{"id":"hydroxychloroquine","rwe":[{"pmid":"41894261","year":"2026","title":"Lupus erythematosus-specific bullous lesions: A case report.","finding":"","journal":"Medicine","studyType":"Clinical Study"},{"pmid":"41891412","year":"2026","title":"Late-Onset Sjögren disease: A different clinical entity?","finding":"","journal":"Sarcoidosis, vasculitis, and diffuse lung diseases : official journal of WASOG","studyType":"Clinical Study"},{"pmid":"41889659","year":"2026","title":"Treatment patterns of biologic disease-modifying anti-rheumatic drugs in juvenile idiopathic arthritis: a population-based study in Korea.","finding":"","journal":"Journal of rheumatic diseases","studyType":"Clinical Study"},{"pmid":"41884851","year":"2026","title":"Immune profiling-informed immunomodulation associated with gestational extension in early-onset preeclampsia with monochorionic twins: a case report.","finding":"","journal":"Frontiers in immunology","studyType":"Clinical Study"},{"pmid":"41883149","year":"2026","title":"Cumulative defined daily doses enables objective assessment of treatment intensity and outcome prediction in immunoglobulin G4-related disease and its subtypes.","finding":"","journal":"Rheumatology (Oxford, England)","studyType":"Clinical Study"}],"_fda":{"id":"40b93dff-c062-433c-e063-6294a90a6b67","set_id":"04139607-f7c0-4fe1-a210-ffa5af347d56","openfda":{"upc":["0382619131017","0382619131024","0382619131031"],"unii":["8Q2869CNVH"],"route":["ORAL"],"rxcui":["979092"],"spl_id":["40b93dff-c062-433c-e063-6294a90a6b67"],"brand_name":["HYDROXYCHLOROQUINE SULFATE"],"spl_set_id":["04139607-f7c0-4fe1-a210-ffa5af347d56"],"package_ndc":["82619-131-01","82619-131-02","82619-131-03"],"product_ndc":["82619-131"],"generic_name":["HYDROXYCHLOROQUINE SULFATE"],"product_type":["HUMAN PRESCRIPTION DRUG"],"substance_name":["HYDROXYCHLOROQUINE SULFATE"],"manufacturer_name":["Creekwood Pharmaceuticals LLC"],"application_number":["ANDA040150"],"is_original_packager":[true]},"version":"3","pregnancy":["8.1 Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to hydroxychloroquine sulfate tablets during pregnancy. Encourage patients to register by contacting 1-877-311-8972. Risk Summary Prolonged clinical experience over decades of use and available data from published epidemiologic and clinical studies with hydroxychloroquine sulfate tablets use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal, or fetal outcomes (see Data) . There are risks to the mother and fetus associated with untreated or increased disease activity from malaria, rheumatoid arthritis, and systemic lupus erythematosus in pregnancy (see Clinical Considerations) . Animal reproduction studies were not conducted with hydroxychloroquine. The estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the US general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Clinical Considerations Disease-Associated Maternal and/or Embryo-Fetal Risk Malaria : Malaria during pregnancy increases the risk for adverse pregnancy outcomes, including maternal anemia, prematurity, spontaneous abortion, and stillbirth. Rheumatoid Arthritis : Published data suggest that increased disease activity is associated with the risk of developing adverse pregnancy outcomes in women with rheumatoid arthritis Adverse pregnancy outcomes include preterm delivery (before 37 weeks of gestation), low birth weight (less than 2500 g) infants, and small for gestational age at birth. Systemic Lupus Erythematosus : Pregnant women with systemic lupus erythematosus, especially those with increased disease activity, are at increased risk of adverse pregnancy outcomes, including spontaneous abortion, fetal death, preeclampsia, preterm birth, and intrauterine growth restriction. Passage of maternal auto-antibodies across the placenta may result in neonatal illness, including neonatal lupus and congenital heart block. Data Human Data Data from published epidemiologic and clinical studies have not established an association with hydroxychloroquine sulfate tablets use during pregnancy and major birth defects, miscarriage, or adverse maternal or fetal outcomes. Hydroxychloroquine readily crosses the placenta with cord blood levels corresponding to maternal plasma levels. No retinal toxicity, ototoxicity, cardiotoxicity, or growth and developmental abnormalities have been observed in children who were exposed to hydroxychloroquine in utero . Available epidemiologic and clinical studies have methodological limitations including small sample size and study design."],"overdosage":["10 OVERDOSAGE Hydroxychloroquine sulfate tablets overdosage symptoms have an onset within 1–3 hours of ingestion. The following have been reported with hydroxychloroquine sulfate tablets overdosage: Cardiovascular toxicity, including QRS or QTc prolongation, ventricular tachycardia, ventricular fibrillation, torsade de pointes, atrioventricular block, cardiac arrest and death. Life-threatening hypotension is common. Severe hypokalemia secondary to an intracellular shift is common in severe toxicity. Central nervous system (CNS) depression, seizures, visual disturbances, transient blindness, and coma may occur. Gastrointestinal decontamination procedures warrant consideration in patients that present within the first hour post-ingestion. If the level of consciousness rapidly deteriorates in severe poisoning, consider intubation before gastrointestinal decontamination procedures. Monitor plasma potassium levels and manage accordingly. Hemofiltration, hemodialysis, and hemoperfusion are not of benefit. Consider contacting a poison center (1-800-221-2222) or a medical toxicologist for overdosage management recommendations."],"references":["15 REFERENCES 1 Center for Disease Control and Prevention. Malaria. https://www.cdc.gov/parasites/malaria/index.html"],"description":["11 DESCRIPTION Hydroxychloroquine sulfate tablets, USP is an antimalarial and antirheumatic drug, chemically described as 2-[[4-[(7-Chloro-4-quinolyl)amino]pentyl]ethylamino] ethanol sulfate (1:1) with the molecular formula C 18 H 26 ClN 3 O•H 2 SO 4 . The molecular weight of hydroxychloroquine sulfate is 433.95. Its structural formula is: Hydroxychloroquine sulfate, USP is a white or practically white crystalline powder, freely soluble in water; practically insoluble in alcohol, chloroform and ether. Hydroxychloroquine sulfate tablets, USP 200 mg for oral administration contain 200 mg hydroxychloroquine sulfate (equivalent to 155 mg of hydroxychloroquine) and the following inactive ingredients: corn starch, pregelatinized starch, anhydrous dibasic calcium phosphate, magnesium stearate, hypromellose 2910(3 mPas), hydroxypropyl cellulose, titanium dioxide, polyethylene glycol 400, hypromellose 2910(50 mPas). Image"],"how_supplied":["16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied Hydroxychloroquine sulfate tablets, USP 200 mg is white, capsule shaped film-coated tablets debossed with \"ꓲꓲꓲ\" on one side and plain on other side. The tablets are available in bottles of: 100 tablets - NDC 82619-131-01 500 tablets - NDC 82619-131-02 1000 tablets - NDC 82619-131-03 16.2 Storage Dispense in a tight, light-resistant container as defined in the USP/NF. Store at 20° to 25°C (68° to 77°F), excursions permitted between 15° and 30°C (59° and 86°F) [See USP Controlled Room Temperature].","16.1 How Supplied Hydroxychloroquine sulfate tablets, USP 200 mg is white, capsule shaped film-coated tablets debossed with \"ꓲꓲꓲ\" on one side and plain on other side. The tablets are available in bottles of: 100 tablets - NDC 82619-131-01 500 tablets - NDC 82619-131-02 1000 tablets - NDC 82619-131-03"],"microbiology":["12.4 Microbiology Mechanism of Action in Malaria The precise mechanism by which hydroxychloroquine exhibits activity against Plasmodium is not known. Hydroxychloroquine is a weak base and may exert its effect by concentrating in the acid vesicles of the parasite and inhibiting polymerization of heme. It can also inhibit certain enzymes by its interaction with DNA. Antimicrobial Activity Hydroxychloroquine is active against the erythrocytic forms of chloroquine sensitive strains of P. falciparum, P. malariae, P. vivax, and P. ovale . Hydroxychloroquine is not active against the gametocytes and exoerythrocytic forms including the hypnozoite liver stage forms of P. vivax and P. ovale . Drug Resistance P. falciparum strains exhibiting reduced susceptibility to chloroquine also show reduced susceptibility to hydroxychloroquine. Resistance of Plasmodium parasites to chloroquine is widespread [see Indications and Usage (1.1) ]."],"geriatric_use":["8.5 Geriatric Use Clinical trials of hydroxychloroquine sulfate tablets did not include sufficient numbers of patients 65 years of age and older to determine whether they respond differently from younger adult patients. Nevertheless, this drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. In general, dose selection in geriatric patients should start with the lowest recommended dose, taking into consideration the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy."],"pediatric_use":["8.4 Pediatric Use The safety and effectiveness of hydroxychloroquine sulfate tablets have been established in pediatric patients for the treatment of uncomplicated malaria due to P. falciparum, P. malariae, P. vivax, and P. ovale , as well as for the prophylaxis of malaria in geographic areas where chloroquine resistance is not reported. However, this product cannot be directly administered to pediatric patients weighing less than 31 kg because the film-coated tablets cannot be crushed or divided [see Dosage and Administration ( 2.1 , 2.2 )]. The safety and effectiveness of hydroxychloroquine sulfate tablets have not been established in pediatric patients for the treatment of rheumatoid arthritis, chronic discoid lupus erythematosus, or systemic lupus erythematosus."],"effective_time":"20251009","pharmacodynamics":["12.2 Pharmacodynamics The exposure-response relationship and time course of pharmacodynamic response for the safety and effectiveness of hydroxychloroquine have not been fully characterized."],"pharmacokinetics":["12.3 Pharmacokinetics Following oral administration, the whole blood concentration of hydroxychloroquine at steady state is dose proportional over a dose range from 200 mg daily to 400 mg daily of hydroxychloroquine sulfate tablets in rheumatoid arthritis and lupus patients. Absorption Following a single 200 mg oral dose of hydroxychloroquine sulfate tablets to healthy male volunteers, whole blood hydroxychloroquine Cmax was 129.6 ng/mL (plasma C max was 50.3 ng/mL) with T max of 3.3 hours (plasma T max 3.7 hours). Peak blood concentrations of metabolites were observed at the same time as peak levels of hydroxychloroquine. Mean absolute oral bioavailability is 79% (SD: 12%) in fasting conditions. Peak blood concentrations ranged from 1161 ng/mL to 2436 ng/mL (mean 1918 ng/mL) following a single dose of 155 mg intravenous infusion and from 2290 ng/mL to 4211 ng/mL (mean 3312 ng/mL) following a single dose of 310 mg intravenous infusion in healthy subjects. Pharmacokinetic parameters were not significantly different over the therapeutic dose range of 155 mg and 310 mg, indicating linear kinetics. In patients with rheumatoid arthritis, there was large variability as to the fraction of the dose absorbed (i.e. 30 to 100%), and mean hydroxychloroquine levels were significantly higher in patients with less disease activity. Distribution Hydroxychloroquine sulfate tablets are extensively distributed to tissues and has a large volume of distribution. Approximately 50% of hydroxychloroquine is bound to plasma proteins. Metabolism Significant levels of three metabolites, desethylhydroxychloroquine (DHCQ), desethylchloroquine (DCQ), and bidesethylhydroxychloroquine (BDCQ) were found in plasma and blood, with DHCQ being the major metabolite. In vitro, hydroxychloroquine is metabolized mainly by CYP2C8, CYP3A4 and CYP2D6 as well as by FMO-1 and MAO-A Elimination / Excretion Renal clearance in patients with rheumatoid arthritis treated with hydroxychloroquine sulfate tablets for at least 6 months was similar to that in single dose studies in healthy volunteers, suggesting that no change in clearance occurred with chronic dosing. Renal clearance of unchanged hydroxychloroquine was approximately 16% to 30% of the dose after oral and IV administration. Results following a single oral dose of a 200 mg tablet demonstrated a half-life of hydroxychloroquine about 40 days in whole blood. Following chronic oral administration of hydroxychloroquine, the absorption half-life of hydroxychloroquine was approximately 3 to 4 hours and the terminal half-life ranged from 40 to 50 days in whole blood. The effective half-life of hydroxychloroquine is likely to be shorter and steady state is achieved by 6 weeks following 400 mg daily oral administration in rheumatoid arthritis patients. Drug Interaction Studies In vitro study suggested that hydroxychloroquine has a potential to inhibit CYP2D6, CYP3A4, P-glycoproteins (P-gp), MATE1 and MATE2-K. In vitro study suggested that hydroxychloroquine has no significant potential to inhibit CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, and the main transporters OATP1B1, OATP1B3, OAT1, OAT3, OCT1, and OCT2. In vitro, hydroxychloroquine has no significant potential to induce CYP1A2, CYP2B6 and CYP3A4."],"adverse_reactions":["6 ADVERSE REACTIONS The following adverse reactions are described in greater detail in other sections: Cardiomyopathy and Ventricular Arrhythmias [see Warnings and Precautions (5.1) ] Retinal Toxicity [see Warnings and Precautions (5.2) ] Serious Skin Reactions [see Warnings and Precautions (5.3) ] Worsening of Psoriasis [see Warnings and Precautions (5.4) ] Risks Associated with Use in Porphyria [see Warnings and Precautions (5.5) ] Hematologic Toxicity [see Warnings and Precautions (5.6) ] Hemolytic Anemia Associated with G6PD [see Warnings and Precautions (5.7) ] Skeletal Muscle Myopathy or Neuropathy [see Warnings and Precautions (5.8) ] Neuropsychiatric Reactions Including Suicidality [see Warnings and Precautions (5.9) ] Hypoglycemia [see Warnings and Precautions (5.10) ] Renal Toxicity [see Warnings and Precautions (5.11) ] The following adverse reactions have been identified during post-approval use of 4-aminoquinoline drugs, including hydroxychloroquine sulfate tablets. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure: Blood and lymphatic system disorders : Bone marrow depression, anemia, aplastic anemia, agranulocytosis, leukopenia, thrombocytopenia Cardiac disorders : Cardiomyopathy, cardiac failure, QT-interval prolongation, ventricular tachycardia, torsades de pointes, atrioventricular block, bundle branch block, sick sinus syndrome, pulmonary hypertension Ear and labyrinth disorders : Vertigo, tinnitus, nystagmus, sensorineural hearing loss Eye disorders : Retinopathy, retinal pigmentation changes (typically bull's eye appearance), visual field defects (paracentral scotomas), macular degeneration, corneal edema, corneal opacities, decreased dark adaptation Gastrointestinal disorders : Nausea, vomiting, diarrhea, abdominal pain General disorders : Fatigue Hepatobiliary disorders : Abnormal liver function tests, fulminant hepatic failure Immune system disorders : Urticaria, angioedema, bronchospasm Metabolism and nutrition disorders : Anorexia, hypoglycemia, weight loss Musculoskeletal and connective tissue disorders : Proximal myopathy, depressed tendon reflexes, abnormal nerve conduction Nervous system disorders : Ataxia, dizziness, headache, seizure, extrapyramidal disorders (dystonia, dyskinesia, tremor) Neuropsychiatric disorders : Affect/emotional lability, irritability, nervousness, psychosis, suicidal ideation, suicidal behavior, depression, hallucinations, anxiety, agitation, confusion, delusions, paranoia, mania and sleep disorders (insomnia, night terrors, nightmares) Skin and subcutaneous tissue disorders : Alopecia, hair color changes, rash, pruritus, photosensitivity, psoriasis exacerbation, hyperpigmentation, exfoliative dermatitis, erythema multiforme, acute generalized exanthematous pustulosis, Drug Rash with Eosinophilia and Systemic Symptoms (DRESS syndrome), Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) The most common adverse reactions reported are: nausea, vomiting, diarrhea, and abdominal pain. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Creekwood Pharmaceuticals LLC. at 1-732-344-0220 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch ."],"contraindications":["4 CONTRAINDICATIONS Hydroxychloroquine sulfate tablets are contraindicated in patients with known hypersensitivity to 4-aminoquinoline compounds. Patients with hypersensitivity to 4-aminoquinoline compounds ( 4 )"],"drug_interactions":["7 DRUG INTERACTIONS Drugs Prolonging QT Interval and Other Arrhythmogenic Drugs. ( 7.1 ) See FPI for more important drug interactions. ( 7 ) 7.1 Drugs Prolonging QT Interval and Other Arrhythmogenic Drugs Hydroxychloroquine sulfate tablets prolongs the QT interval. There may be an increased risk of inducing ventricular arrhythmias if hydroxychloroquine sulfate tablets are used concomitantly with other arrhythmogenic drugs. Therefore, hydroxychloroquine sulfate tablets are not recommended in patients taking other drugs that have the potential to prolong the QT interval or are arrhythmogenic [see Warnings and Precautions (5.1) ]. 7.2 Insulin or Other Antidiabetic Drugs Hydroxychloroquine sulfate tablets may enhance the effects of insulin and antidiabetic drugs, and consequently increase the hypoglycemic risk. Therefore, a decrease in dosage of insulin and other antidiabetic drugs may be necessary [see Warnings and Precautions (5.10) ]. 7.3 Drugs that Lower the Seizure Threshold Hydroxychloroquine sulfate tablets can lower the seizure threshold. Co-administration of hydroxychloroquine sulfate tablets with other antimalarials known to lower the seizure threshold (e.g., mefloquine) may increase the risk of seizures. 7.4 Antiepileptics The activity of antiepileptic drugs might be impaired if co-administered with hydroxychloroquine sulfate tablets. 7.5 Methotrexate Concomitant use of hydroxychloroquine sulfate tablets and methotrexate may increase the incidence of adverse reactions. 7.6 Cyclosporine An increased plasma cyclosporine level was reported when cyclosporine and hydroxychloroquine sulfate tablets were co-administered. Monitor serum cyclosporine levels closely in patients receiving combined therapy. 7.7 Digoxin Concomitant hydroxychloroquine sulfate tablets and digoxin therapy may result in increased serum digoxin levels. Monitor serum digoxin levels closely in patients receiving combined therapy. 7.8 Cimetidine Concomitant use of cimetidine resulted in a 2-fold increase of exposure of chloroquine, which is structurally related to hydroxychloroquine. Interaction of cimetidine with hydroxychloroquine cannot be ruled out. Avoid concomitant use of cimetidine. 7.9 Rifampicin Lack of efficacy of hydroxychloroquine was reported when rifampicin was concomitantly administered. Avoid concomitant use of rifampicin. 7.10 Praziquantel Chloroquine has been reported to reduce the bioavailability of praziquantel. Interaction of praziquantel with hydroxychloroquine cannot be ruled out. 7.11 Antacids and kaolin Antacids and kaolin can reduce absorption of chloroquine; an interval of at least 4 hours between intake of these agents and chloroquine should be observed. Interaction of antacids and kaolin with hydroxychloroquine cannot be ruled out. 7.12 Ampicillin In a study of healthy volunteers, chloroquine significantly reduced the bioavailability of ampicillin. Interaction of ampicillin with hydroxychloroquine cannot be ruled out."],"mechanism_of_action":["12.1 Mechanism of Action Malaria Hydroxychloroquine is a 4-aminoquinoline antimalarial [see Microbiology (12.4) ] and antirheumatic agent. Rheumatoid Arthritis, Systemic Lupus Erythematosus and Chronic Discoid Lupus Erythematosus The mechanisms underlying the anti-inflammatory and immunomodulatory effects of hydroxychloroquine sulfate tablets in the treatment of rheumatoid arthritis, chronic discoid lupus erythematosus and systemic lupus erythematosus are not fully known."],"recent_major_changes":["RECENT MAJOR CHANGES Warnings and Precautions, Risks Associated with Use in Porphyria ( 5.5 ) ………………………………………….............................7/2023 Warnings and Precautions, Neuropsychiatric Reactions Including Suicidality ( 5.9 ) ………………………………………………….7/2023"],"clinical_pharmacology":["12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action Malaria Hydroxychloroquine is a 4-aminoquinoline antimalarial [see Microbiology (12.4) ] and antirheumatic agent. Rheumatoid Arthritis, Systemic Lupus Erythematosus and Chronic Discoid Lupus Erythematosus The mechanisms underlying the anti-inflammatory and immunomodulatory effects of hydroxychloroquine sulfate tablets in the treatment of rheumatoid arthritis, chronic discoid lupus erythematosus and systemic lupus erythematosus are not fully known. 12.2 Pharmacodynamics The exposure-response relationship and time course of pharmacodynamic response for the safety and effectiveness of hydroxychloroquine have not been fully characterized. 12.3 Pharmacokinetics Following oral administration, the whole blood concentration of hydroxychloroquine at steady state is dose proportional over a dose range from 200 mg daily to 400 mg daily of hydroxychloroquine sulfate tablets in rheumatoid arthritis and lupus patients. Absorption Following a single 200 mg oral dose of hydroxychloroquine sulfate tablets to healthy male volunteers, whole blood hydroxychloroquine Cmax was 129.6 ng/mL (plasma C max was 50.3 ng/mL) with T max of 3.3 hours (plasma T max 3.7 hours). Peak blood concentrations of metabolites were observed at the same time as peak levels of hydroxychloroquine. Mean absolute oral bioavailability is 79% (SD: 12%) in fasting conditions. Peak blood concentrations ranged from 1161 ng/mL to 2436 ng/mL (mean 1918 ng/mL) following a single dose of 155 mg intravenous infusion and from 2290 ng/mL to 4211 ng/mL (mean 3312 ng/mL) following a single dose of 310 mg intravenous infusion in healthy subjects. Pharmacokinetic parameters were not significantly different over the therapeutic dose range of 155 mg and 310 mg, indicating linear kinetics. In patients with rheumatoid arthritis, there was large variability as to the fraction of the dose absorbed (i.e. 30 to 100%), and mean hydroxychloroquine levels were significantly higher in patients with less disease activity. Distribution Hydroxychloroquine sulfate tablets are extensively distributed to tissues and has a large volume of distribution. Approximately 50% of hydroxychloroquine is bound to plasma proteins. Metabolism Significant levels of three metabolites, desethylhydroxychloroquine (DHCQ), desethylchloroquine (DCQ), and bidesethylhydroxychloroquine (BDCQ) were found in plasma and blood, with DHCQ being the major metabolite. In vitro, hydroxychloroquine is metabolized mainly by CYP2C8, CYP3A4 and CYP2D6 as well as by FMO-1 and MAO-A Elimination / Excretion Renal clearance in patients with rheumatoid arthritis treated with hydroxychloroquine sulfate tablets for at least 6 months was similar to that in single dose studies in healthy volunteers, suggesting that no change in clearance occurred with chronic dosing. Renal clearance of unchanged hydroxychloroquine was approximately 16% to 30% of the dose after oral and IV administration. Results following a single oral dose of a 200 mg tablet demonstrated a half-life of hydroxychloroquine about 40 days in whole blood. Following chronic oral administration of hydroxychloroquine, the absorption half-life of hydroxychloroquine was approximately 3 to 4 hours and the terminal half-life ranged from 40 to 50 days in whole blood. The effective half-life of hydroxychloroquine is likely to be shorter and steady state is achieved by 6 weeks following 400 mg daily oral administration in rheumatoid arthritis patients. Drug Interaction Studies In vitro study suggested that hydroxychloroquine has a potential to inhibit CYP2D6, CYP3A4, P-glycoproteins (P-gp), MATE1 and MATE2-K. In vitro study suggested that hydroxychloroquine has no significant potential to inhibit CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, and the main transporters OATP1B1, OATP1B3, OAT1, OAT3, OCT1, and OCT2. In vitro, hydroxychloroquine has no significant potential to induce CYP1A2, CYP2B6 and CYP3A4. 12.4 Microbiology Mechanism of Action in Malaria The precise mechanism by which hydroxychloroquine exhibits activity against Plasmodium is not known. Hydroxychloroquine is a weak base and may exert its effect by concentrating in the acid vesicles of the parasite and inhibiting polymerization of heme. It can also inhibit certain enzymes by its interaction with DNA. Antimicrobial Activity Hydroxychloroquine is active against the erythrocytic forms of chloroquine sensitive strains of P. falciparum, P. malariae, P. vivax, and P. ovale . Hydroxychloroquine is not active against the gametocytes and exoerythrocytic forms including the hypnozoite liver stage forms of P. vivax and P. ovale . Drug Resistance P. falciparum strains exhibiting reduced susceptibility to chloroquine also show reduced susceptibility to hydroxychloroquine. Resistance of Plasmodium parasites to chloroquine is widespread [see Indications and Usage (1.1) ]."],"indications_and_usage":["1 INDICATIONS AND USAGE Hydroxychloroquine sulfate tablets are an antimalarial and antirheumatic indicated for the: Treatment of uncomplicated malaria due to Plasmodium falciparum, Plasmodium malariae, Plasmodium ovale, and Plasmodium vivax in adult and pediatric patients. ( 1.1 ) Prophylaxis of malaria in geographic areas where chloroquine resistance is not reported in adult and pediatric patients. ( 1.1 ) Treatment of rheumatoid arthritis in adults. ( 1.2 ) Treatment of systemic lupus erythematosus in adults. ( 1.3 ) Treatment of chronic discoid lupus erythematosus in adults. ( 1.4 ) Limitations of Use ( 1.1 ): Hydroxychloroquine sulfate tablets are not recommended for the: Treatment of complicated malaria. Treatment of chloroquine or hydroxychloroquine-resistant strains of Plasmodium species. Treatment of malaria acquired in geographic areas where chloroquine resistance occurs or when the Plasmodium species has not been identified. Prophylaxis of malaria in geographic areas where chloroquine resistance occurs. Prevention of relapses of P. vivax or P. ovale because it is not active against the hypnozoite liver stage forms of these parasites. For radical cure of P. vivax and P. ovale infections, concomitant therapy with an 8-aminoquinoline drug is necessary. 1.1 Malaria Hydroxychloroquine sulfate tablets are indicated in adult and pediatric patient for the: Treatment of uncomplicated malaria due to Plasmodium falciparum, Plasmodium malariae, Plasmodium vivax, and Plasmodium ovale. Prophylaxis of malaria in geographic areas where chloroquine resistance is not reported. Limitations of Use : Hydroxychloroquine sulfate tablets are not recommended for: Treatment of complicated malaria. Treatment of malaria by chloroquine or hydroxychloroquine-resistant strains of Plasmodium species [see Microbiology (12.4) ]. Treatment of malaria acquired in geographic areas where chloroquine resistance occurs or when the Plasmodium species has not been identified. Prophylaxis of malaria in geographic areas where chloroquine resistance occurs. Prevention of relapses of P. vivax or P. ovale because it is not active against the hypnozoite liver stage forms of these parasites. For radical cure of P. vivax and P. ovale infections, concomitant therapy with an 8-aminoquinoline drug is necessary [see Microbiology (12.4) ]. For the most current information about drug resistance, refer to the latest recommendations from the Center for Disease Control and Prevention1. 1.2 Rheumatoid Arthritis Hydroxychloroquine sulfate tablets are indicated for the treatment of acute and chronic rheumatoid arthritis in adults. 1.3 Systemic Lupus Erythematosus Hydroxychloroquine sulfate tablets are indicated for the treatment of systemic lupus erythematosus in adults. 1.4 Chronic Discoid Lupus Erythematosus Hydroxychloroquine sulfate tablets are indicated for the treatment of chronic discoid lupus erythematosus in adults."],"warnings_and_cautions":["5 WARNINGS AND PRECAUTIONS Cardiomyopathy and Ventricular Arrhythmias : Fatal or life-threatening cardiomyopathy and ventricular arrhythmias were reported. ( 5.1 ) Retinal Toxicity : Irreversible retinal damage is related to cumulative dosage and treatment duration. Baseline retinal exam and exams during treatment are recommended. ( 5.2 ) Serious Skin Reactions : Stevens Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms, acute generalized exanthematous pustulosis have been reported. ( 5.3 ) Worsening of Psoriasis : Avoid in patients with psoriasis. ( 5.4 ) Risks Associated with Use in Porphyria : Avoid in patients with porphyria. Hepatotoxicity was reported in patients with porphyria cutanea tarda ( 5.5 ). Hematologic Toxicity : Discontinue if myelosuppression occurs. ( 5.6 ) Renal Toxicity : Consider phospholipidosis as a possible cause of renal injury in patients with underlying connective tissue disorders. Discontinue hydroxychloroquine sulfate tablets if renal toxicity is suspected or demonstrated by tissue biopsy in any organ system. ( 5.1 , 5.8 , 5.11 ) 5.1 Cardiomypathy and Ventricular Arrhythmias Fatal and life-threatening cases of cardiotoxicity, including cardiomyopathy, have been reported in patients treated with hydroxychloroquine sulfate tablets. Signs and symptoms of cardiac compromise have occurred during acute and chronic hydroxychloroquine sulfate tablets treatment. In multiple cases, endomyocardial biopsy showed association of the cardiomyopathy with phospholipidosis in the absence of inflammation, infiltration, or necrosis. Drug-induced phospholipidosis may occur in other organ systems [see Warnings and Precautions ( 5.8 , 5.11 )]. Patients may present with ventricular hypertrophy, pulmonary hypertension and conduction disorders including sick sinus syndrome. ECG findings include atrioventricular, right or left bundle branch block. Hydroxychloroquine sulfate tablets has a potential to prolong the QT interval. Ventricular arrhythmias (including torsades de pointes) have been reported in hydroxychloroquine sulfate tablets-treated patients. The magnitude of QT prolongation may increase with increasing concentrations of the drug. Therefore, the recommended dose should not be exceeded [see Adverse Reactions (6) , Overdosage (10) ]. Avoid hydroxychloroquine sulfate tablets administration in patients with congenital or documented acquired QT prolongation and/or known risk factors for prolongation of the QT interval such as: Cardiac disease, e.g., heart failure, myocardial infarction. Proarrhythmic conditions, e.g., bradycardia (< 50 bpm). History of ventricular dysrhythmias. Uncorrected hypokalemia and/or hypomagnesemia. Concomitant administration with QT interval prolonging agents as this may lead to an increased risk for ventricular arrhythmias [see Drug Interactions (7.1) ]. Therefore, hydroxychloroquine sulfate tablets are not recommended in patients taking other drugs that have the potential to prolong the QT interval. Correct electrolyte imbalances prior to use. Monitor cardiac function as clinically indicated during hydroxychloroquine sulfate tablets therapy. Discontinue hydroxychloroquine sulfate tablets if cardiotoxicity is suspected or demonstrated by tissue biopsy. 5.2 Retinal Toxicity Irreversible retinal damage was observed in some patients treated with hydroxychloroquine sulfate and it is related to cumulative dosage and treatment duration. In patients of Asian descent, retinal toxicity may first be noticed outside the macula. Risk factors for retinal damage include daily hydroxychloroquine sulfate dosages ≥5 mg/kg of actual body weight, durations of use greater than five years, renal impairment, use of concomitant drug products such as tamoxifen citrate, and concurrent macular disease. Within the first year of starting hydroxychloroquine sulfate tablets, a baseline ocular examination is recommended including best corrected distance visual acuity (BCVA), an automated threshold visual field (VF) of the central 10 degrees (with retesting if an abnormality is noted), and spectral domain ocular coherence tomography (SD-OCT). For patients at higher risk of retinal damage, monitoring should include annual examinations which include BCVA, VF and SD-OCT. For patients without significant risk factors, annual retinal exams can usually be deferred until five years of treatment. In patients of Asian descent, it is recommended that visual field testing be performed in the central 24 degrees instead of the central 10 degrees. If ocular toxicity is suspected, discontinue hydroxychloroquine sulfate tablets and monitor the patient closely given that retinal changes and visual disturbances may progress even after cessation of therapy. 5.3 Serious Skin Reactions Serious adverse reactions have been reported with the use of hydroxychloroquine sulfate tablets including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), acute generalized exanthematous pustulosis (AGEP). Monitor for serious skin reactions, especially in patients receiving a drug that may also induce dermatitis. Advise patients to seek medical attention promptly if they experience signs and symptoms of serious skin reactions such as blisters on the skin, eyes, lips or in the mouth, itching or burning, with or without fever [see Warnings and Precautions ( 5.4 , 5.5 ), Adverse Reactions (6) ]. Discontinue hydroxychloroquine sulfate tablets if these severe reactions occur. 5.4 Worsening of Psoriasis Administration of hydroxychloroquine sulfate tablets to patients with psoriasis may precipitate a severe flare-up of psoriasis. Avoid hydroxychloroquine sulfate tablets in patients with psoriasis, unless the benefit to the patient outweighs the possible risk. 5.5 Risks Associated with Use in Porphyria Administration of hydroxychloroquine sulfate tablets to patients with porphyria may exacerbate porphyria. Avoid hydroxychloroquine sulfate tablets in patients with porphyria. Hepatotoxicity Associated with Porphyria Cutanea Tarda Cases of hepatotoxicity have been reported when hydroxychloroquine was used in patients with porphyria cutanea tarda (PCT). Patients received dosages ranging from 200 mg twice weekly to 400 mg daily. Most of the PCT-related cases presented with marked elevations in transaminases (>20 times upper limit of the reference range) within days to a month of hydroxychloroquine initiation. In some cases, PCT was diagnosed only after the occurrence of treatment-induced liver injury, when hydroxychloroquine was prescribed for an approved indication. Some of the cases were associated with other risk factors for hepatic injury (e.g., alcohol use, concomitant hepatotoxic medications). Measure liver tests promptly in patients who report symptoms that may indicate liver injury, such as fatigue, rash, nausea, dark urine, or jaundice. In this clinical context, if the patient is found to have abnormal serum liver tests (e.g., ALT level greater than three times the upper limit of the reference range, total bilirubin greater than two times the upper limit of the reference range), interrupt treatment with Hydroxychloroquine sulfate tablets, and investigate further to establish the probable cause. The safety and effectiveness of hydroxychloroquine sulfate tablets for the treatment of PCT have not been established and hydroxychloroquine sulfate tablets are not approved for this use. 5.6 Hematologic Toxicity Hydroxychloroquine sulfate tablets may cause myelosuppression including aplastic anemia, agranulocytosis, leukopenia, or thrombocytopenia. Monitor blood cell counts periodically in patients on prolonged hydroxychloroquine sulfate tablets therapy. If the patient develops myelosuppression which cannot be attributable to the disease, discontinue the drug. 5.7 Hemolytic Anemia Associated with G6PD Deficiency Hemolysis has been reported in patients with glucose-6-phosphate dehydrogenase (G6PD) deficiency. Monitor for hemolytic anemia as this can occur, particularly in association with other drugs that cause hemolysis. 5.8 Skeletal Muscle Myopathy or Neuropathy Skeletal muscle myopathy or neuropathy leading to progressive weakness and atrophy of proximal muscle groups, depressed tendon reflexes, and abnormal nerve conduction, have been reported. Muscle and nerve biopsies have shown associated phospholipidosis. Drug-induced phospholipidosis may occur in other organ systems [see Warnings and Precautions ( 5.1 , 5.11 )]. Assess muscle strength and deep tendon reflexes periodically in patients on long-term therapy with hydroxychloroquine sulfate tablets. Discontinue hydroxychloroquine sulfate tablets if muscle or nerve toxicity is suspected or demonstrated by tissue biopsy. 5.9 Neuropsychiatric Reactions Including Suicidality Suicidal behavior, suicidal ideation, and other neuropsychiatric adverse reactions have been reported in patients treated with hydroxychloroquine sulfate tablets [see Adverse Reactions (6) ]. Neuropsychiatric adverse reactions typically occurred within the first month after the start of treatment with hydroxychloroquine and have been reported in patients with and without a prior history of psychiatric disorders. The risks and benefits of continued treatment with hydroxychloroquine sulfate tablets should be assessed for patients who develop these symptoms. Given the long half-life of the drug, some patients may require several weeks off drug for symptoms to partially or fully abate. Advise patients to contact their healthcare provider promptly if they experience new or worsening neuropsychiatric symptoms such as depression, suicidal thoughts or behavior, or mood changes. 5.10 Hypoglycemia Hydroxychloroquine sulfate tablets can cause severe and potentially life-threatening hypoglycemia, in the presence or absence of antidiabetic agents [see Drug Interactions (7) ]. Measure blood glucose in patients presenting with clinical symptoms suggestive of hypoglycemia and as adjust the antidiabetic treatment as necessary. Warn hydroxychloroquine sulfate tablets-treated patients about the risk of hypoglycemia and educate them on the signs and symptoms of hypoglycemia; diabetic patients should monitor their blood sugar levels. Advise patients to seek medical attention if they develop any signs and symptoms of hypoglycemia. 5.11 Renal Toxicity Proteinuria with or without moderate reduction in glomerular filtration rate have been reported with the use of hydroxychloroquine sulfate tablets. Renal biopsy showed phospholipidosis without immune deposits, inflammation, and/or increased cellularity. Physicians should consider phospholipidosis as a possible cause of renal injury in patients with underlying connective tissue disorders who are receiving hydroxychloroquine sulfate tablets. Drug- induced phospholipidosis may occur in other organ systems [see Warnings and Precautions ( 5.1 , 5.8 )]. Discontinue hydroxychloroquine sulfate tablets if renal toxicity is suspected or demonstrated by tissue biopsy."],"nonclinical_toxicology":["13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility No carcinogenicity or genotoxicity studies have been conducted with hydroxychloroquine. No animal studies have been performed to evaluate the potential effects of hydroxychloroquine on reproduction or development, or to determine potential effects on fertility in males or females."],"information_for_patients":["17 PATIENT COUNSELING INFORMATION Important Administration Instructions Advise the patient to take hydroxychloroquine sulfate tablets with food or milk and not to crush or divide the tablet. Cardiomyopathy and Ventricular Arrhythmias Inform the patient that serious cardiac effects, life-threatening and fatal cases have been reported with use of hydroxychloroquine sulfate tablets. Advise patients to seek medical attention immediately if they experience any symptoms of heart rhythm changes including fast or irregular heartbeat, lightheadedness, dizziness, or syncope [see Warnings and Precautions (5.1) ]. Retinal Toxicity Inform the patient that irreversible retinal damage has been observed in some patients with the use of hydroxychloroquine sulfate tablets. Advise patients of the importance of the ophthalmology visits for monitoring their eyes. Instruct patients to seek medical attention promptly if they experience decreased vision or decreased dark adaptation [see Warnings and Precautions (5.2) ]. Serious Skin Reactions Inform the patient that severe, life-threatening skin reactions have been reported with the use of hydroxychloroquine sulfate tablets. Advise the patient to seek medical attention immediately if experiencing any of the following signs and symptoms: blisters on the skin, eyes, lips or in the mouth, itching or burning, with or without fever [see Warnings and Precautions (5.3) ]. Hepatotoxicity Associated with Porphyria Cutanea Tarda Inform the patient that liver toxicity has been reported in when hydroxychloroquine sulfate tablets was used in patients with porphyria cutanea tarda. In some cases, PCT was diagnosed only after the occurrence of liver injury, when hydroxychloroquine sulfate tablets was prescribed for an approved indication. Advise the patient to seek medical attention if experiencing fatigue, rash, nausea, dark urine, or jaundice [see Warnings and Precautions (5.5) ]. Skeletal Muscle Myopathy or Neuropathy Inform the patient that muscle weakness and atrophy has been reported with hydroxychloroquine sulfate tablets use. Advise patients to report to the physician symptoms of muscle weakness [see Warnings and Precautions (5.8) ]. Neuropsychiatric Reactions Including Suicidality Alert patients to seek medical attention immediately if they experience new or worsening depression, suicidal thoughts, or other mood changes [see Warnings and Precautions (5.9) ]. Hypoglycemia Inform the patient that hydroxychloroquine sulfate tablets has been associated with severe hypoglycemia. Advise the patient to monitor blood sugar levels if possible and to seek medical attention if experiencing any of the signs and symptoms of hypoglycemia such as sweating, shakiness, weakness, dizziness, tachycardia, nausea, blurred vision, confusion, fainting, or loss of consciousness [see Warnings and Precautions (5.10) ]. Pregnancy Inform the patient that there is a pregnancy registry that monitors pregnancy outcomes in women exposed to hydroxychloroquine sulfate tablets during pregnancy. Encourage patients to register by contacting 1-877-311-8972 [see Use in Specific Populations (8.1) ]. Manufactured by: V-Ensure Pharma Technologies Pvt. Ltd. Raigad, Maharashtra 410206, India. Distributed by: Creekwood Pharmaceuticals LLC. Parsippany, NJ 07054. PA1310102 Revised: 05/2025"],"dosage_and_administration":["2 DOSAGE AND ADMINISTRATION Malaria in Adult and Pediatric Patients ( 2.2 ): ● Prophylaxis: Begin weekly doses 2 weeks prior to travel to the endemic area, continue weekly doses while in the endemic area, and continue the weekly doses for 4 weeks after leaving the endemic area: - Adults: 400 mg once a week - Pediatric patients ≥ 31 kg: 6.5 mg/kg up to 400 mg, once a week ● Treatment of Uncomplicated Malaria: See Full Prescribing Information (FPI) for complete dosing information. Rheumatoid Arthritis in Adults ( 2.3 ): Initial dosage: 400 mg to 600 mg daily Chronic dosage: 200 mg once daily or 400 mg once daily (or in two divided doses) Systemic Lupus Erythematosus in Adults ( 2.4 ): 200 mg once daily or 400 mg once daily (or in two divided doses) Chronic Discoid Lupus Erythematosus in Adults ( 2.5 ): 200 mg once daily or 400 mg once daily (or in two divided doses) 2.1 Important Administration Instructions Administer hydroxychloroquine sulfate tablets orally with food or milk. Do not crush or divide the tablets. 2.2 Dosage for Malaria in Adult and Pediatric Patients Hydroxychloroquine sulfate tablets are not recommended in pediatric patients less than 31 kg because the lowest available strength (200 mg) exceeds the recommended dose for these patients and it cannot be divided. Prophylaxis Treatment must start 2 weeks before travel to an endemic area. Advise the patient to take the prophylaxis dosage once a week, staring 2 weeks prior to travel to the endemic area, on the same day every week, continuing the same weekly dose while in the endemic area, and for 4 weeks after leaving the endemic area. The recommended prophylaxis dosage is: Adult patients: 400 mg once a week Pediatric patients ≥ 31kg: 6.5 mg/kg actual body weight (up to 400 mg) once a week Treatment of Uncomplicated Malaria The dosages for the treatment of uncomplicated malaria are: Adult patients: Administer 800 mg initially; subsequently administer 400 mg at 6 hours, 24 hours, and 48 hours after the initial dose (total dosage = 2000 mg). Pediatric patients ≥ 31 kg: Administer 13 mg/kg (up to 800 mg) initially; subsequently administer 6.5 mg/kg (up to 400 mg) at 6 hours, 24 hours, and 48 hours after the initial dose (total dosage = 31 mg/kg - up to 2000 mg). For radical cure of P. vivax and P. ovale infections, concomitant therapy with an 8-aminoquinoline drug is necessary [see Microbiology (12.4) ]. 2.3 Dosage for Rheumatoid Arthritis in Adults The recommended dosage is: Initial dosage: 400 mg to 600 mg daily as a single daily dose or two divided doses. The action of hydroxychloroquine is cumulative and may require weeks to months for maximum therapeutic effect. Daily doses exceeding 5 mg/kg (actual weight) of hydroxychloroquine sulfate increase the incidence of retinopathy [see Warnings and Precautions (5.2) ]. Chronic dosage: 200 mg once daily to 400 mg daily, as a single dose or two divided doses. Corticosteroids, salicylates, and other antirheumatic agents may be used concomitantly with hydroxychloroquine sulfate tablets. 2.4 Dosage for Systemic Lupus Erythematosus in Adults The recommended dosage is 200 mg given once daily, or 400 mg given once daily or in two divided doses. 2.5 Dosage for Chronic Discoid Lupus Erythematosus in Adults The recommended dosage is 200 mg given once daily, or 400 mg given once daily or in two divided doses."],"spl_product_data_elements":["HYDROXYCHLOROQUINE SULFATE hydroxychloroquine sulfate STARCH, CORN ANHYDROUS DIBASIC CALCIUM PHOSPHATE MAGNESIUM STEARATE HYPROMELLOSE 2910 (3 MPA.S) HYDROXYPROPYL CELLULOSE, UNSPECIFIED TITANIUM DIOXIDE POLYETHYLENE GLYCOL 400 HYPROMELLOSE, UNSPECIFIED HYDROXYCHLOROQUINE SULFATE HYDROXYCHLOROQUINE lll"],"dosage_forms_and_strengths":["3 DOSAGE FORMS AND STRENGTHS Hydroxychloroquine sulfate tablets, USP 200 mg are white, capsule shaped film-coated tablets debossed with \"ꓲꓲꓲ\" on one side and plain on other side. Tablets: 200 mg of hydroxychloroquine sulfate ( 3 )"],"use_in_specific_populations":["8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to hydroxychloroquine sulfate tablets during pregnancy. Encourage patients to register by contacting 1-877-311-8972. Risk Summary Prolonged clinical experience over decades of use and available data from published epidemiologic and clinical studies with hydroxychloroquine sulfate tablets use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal, or fetal outcomes (see Data) . There are risks to the mother and fetus associated with untreated or increased disease activity from malaria, rheumatoid arthritis, and systemic lupus erythematosus in pregnancy (see Clinical Considerations) . Animal reproduction studies were not conducted with hydroxychloroquine. The estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the US general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Clinical Considerations Disease-Associated Maternal and/or Embryo-Fetal Risk Malaria : Malaria during pregnancy increases the risk for adverse pregnancy outcomes, including maternal anemia, prematurity, spontaneous abortion, and stillbirth. Rheumatoid Arthritis : Published data suggest that increased disease activity is associated with the risk of developing adverse pregnancy outcomes in women with rheumatoid arthritis Adverse pregnancy outcomes include preterm delivery (before 37 weeks of gestation), low birth weight (less than 2500 g) infants, and small for gestational age at birth. Systemic Lupus Erythematosus : Pregnant women with systemic lupus erythematosus, especially those with increased disease activity, are at increased risk of adverse pregnancy outcomes, including spontaneous abortion, fetal death, preeclampsia, preterm birth, and intrauterine growth restriction. Passage of maternal auto-antibodies across the placenta may result in neonatal illness, including neonatal lupus and congenital heart block. Data Human Data Data from published epidemiologic and clinical studies have not established an association with hydroxychloroquine sulfate tablets use during pregnancy and major birth defects, miscarriage, or adverse maternal or fetal outcomes. Hydroxychloroquine readily crosses the placenta with cord blood levels corresponding to maternal plasma levels. No retinal toxicity, ototoxicity, cardiotoxicity, or growth and developmental abnormalities have been observed in children who were exposed to hydroxychloroquine in utero . Available epidemiologic and clinical studies have methodological limitations including small sample size and study design. 8.2 Lactation Risk Summary Published lactation data report that hydroxychloroquine is present in human milk at low levels. No adverse reactions have been reported in breastfed infants. No retinal toxicity, ototoxicity, cardiotoxicity, or growth and developmental abnormalities have been observed in children who were exposed to hydroxychloroquine through breastmilk. There is no information on the effect of hydroxychloroquine on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for hydroxychloroquine sulfate tablets and any potential adverse effects on the breastfed child from hydroxychloroquine sulfate tablets or from the underlying maternal condition. 8.4 Pediatric Use The safety and effectiveness of hydroxychloroquine sulfate tablets have been established in pediatric patients for the treatment of uncomplicated malaria due to P. falciparum, P. malariae, P. vivax, and P. ovale , as well as for the prophylaxis of malaria in geographic areas where chloroquine resistance is not reported. However, this product cannot be directly administered to pediatric patients weighing less than 31 kg because the film-coated tablets cannot be crushed or divided [see Dosage and Administration ( 2.1 , 2.2 )]. The safety and effectiveness of hydroxychloroquine sulfate tablets have not been established in pediatric patients for the treatment of rheumatoid arthritis, chronic discoid lupus erythematosus, or systemic lupus erythematosus. 8.5 Geriatric Use Clinical trials of hydroxychloroquine sulfate tablets did not include sufficient numbers of patients 65 years of age and older to determine whether they respond differently from younger adult patients. Nevertheless, this drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. In general, dose selection in geriatric patients should start with the lowest recommended dose, taking into consideration the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy. 8.6 Patients with Renal or Hepatic Disease A reduction in the dosage of hydroxychloroquine sulfate tablets may be necessary in patients with hepatic or renal disease."],"package_label_principal_display_panel":["PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 82619-131-01 Hydroxychloroquine Sulfate Tablets, USP 200 mg Rx Only 100 Tablets image","PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 82619-131-02 Hydroxychloroquine Sulfate Tablets, USP 200 mg Rx Only 500 Tablets Image","PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 82619-131-03 Hydroxychloroquine Sulfate Tablets, USP 200 mg Rx Only 1000 Tablets image"],"carcinogenesis_and_mutagenesis_and_impairment_of_fertility":["13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility No carcinogenicity or genotoxicity studies have been conducted with hydroxychloroquine. No animal studies have been performed to evaluate the potential effects of hydroxychloroquine on reproduction or development, or to determine potential effects on fertility in males or females."]},"tags":[{"label":"Antimalarial","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"Toll-like receptor 9","category":"target"},{"label":"TLR9","category":"gene"},{"label":"SIGMAR1","category":"gene"},{"label":"TMEM97","category":"gene"},{"label":"P01BA02","category":"atc"},{"label":"Oral","category":"route"},{"label":"Tablet","category":"form"},{"label":"Off-Patent","category":"patent"},{"label":"Generic Available","category":"availability"},{"label":"Established","category":"status"},{"label":"Discoid lupus erythematosus","category":"indication"},{"label":"Falciparum malaria","category":"indication"},{"label":"Malaria Prevention","category":"indication"},{"label":"Ovale malaria","category":"indication"},{"label":"Plasmodium Falciparum Malaria Prevention","category":"indication"},{"label":"Plasmodium Malariae Malaria Prevention","category":"indication"},{"label":"Advanz Pharma","category":"company"},{"label":"Approved 1950s","category":"decade"},{"label":"Anti-Infective Agents","category":"pharmacology"},{"label":"Antimalarials","category":"pharmacology"},{"label":"Antiparasitic Agents","category":"pharmacology"},{"label":"Antiprotozoal Agents","category":"pharmacology"},{"label":"Antirheumatic Agents","category":"pharmacology"},{"label":"Enzyme Inhibitors","category":"pharmacology"}],"phase":"marketed","safety":{"boxedWarnings":[],"safetySignals":[{"llr":10167.065,"date":"","count":27482,"signal":"Drug ineffective","source":"DrugCentral FAERS","actionTaken":"Reported 27,482 times (LLR=10167)"},{"llr":8290.827,"date":"","count":11470,"signal":"Drug intolerance","source":"DrugCentral FAERS","actionTaken":"Reported 11,470 times (LLR=8291)"},{"llr":6444.617,"date":"","count":8342,"signal":"Contraindicated product administered","source":"DrugCentral FAERS","actionTaken":"Reported 8,342 times (LLR=6445)"},{"llr":5890.531,"date":"","count":9964,"signal":"Joint swelling","source":"DrugCentral FAERS","actionTaken":"Reported 9,964 times (LLR=5891)"},{"llr":5828.327,"date":"","count":8586,"signal":"Rheumatoid arthritis","source":"DrugCentral FAERS","actionTaken":"Reported 8,586 times (LLR=5828)"},{"llr":5560.989,"date":"","count":6966,"signal":"Synovitis","source":"DrugCentral FAERS","actionTaken":"Reported 6,966 times (LLR=5561)"},{"llr":4563.04,"date":"","count":7097,"signal":"Treatment failure","source":"DrugCentral FAERS","actionTaken":"Reported 7,097 times (LLR=4563)"},{"llr":3985.308,"date":"","count":6835,"signal":"Arthropathy","source":"DrugCentral FAERS","actionTaken":"Reported 6,835 times (LLR=3985)"},{"llr":3983.826,"date":"","count":6195,"signal":"Systemic lupus erythematosus","source":"DrugCentral FAERS","actionTaken":"Reported 6,195 times (LLR=3984)"},{"llr":3741.323,"date":"","count":6131,"signal":"Therapeutic product effect decreased","source":"DrugCentral FAERS","actionTaken":"Reported 6,131 times (LLR=3741)"},{"llr":3390.232,"date":"","count":5383,"signal":"Pemphigus","source":"DrugCentral FAERS","actionTaken":"Reported 5,383 times (LLR=3390)"},{"llr":3001.207,"date":"","count":7305,"signal":"Alopecia","source":"DrugCentral FAERS","actionTaken":"Reported 7,305 times (LLR=3001)"},{"llr":2916.333,"date":"","count":4661,"signal":"Hand deformity","source":"DrugCentral FAERS","actionTaken":"Reported 4,661 times (LLR=2916)"},{"llr":2886.433,"date":"","count":7382,"signal":"Abdominal discomfort","source":"DrugCentral FAERS","actionTaken":"Reported 7,382 times (LLR=2886)"},{"llr":2847.594,"date":"","count":4905,"signal":"Glossodynia","source":"DrugCentral FAERS","actionTaken":"Reported 4,905 times (LLR=2848)"}],"commonSideEffects":[{"effect":"Drug intolerance","drugRate":"","severity":"serious","_validated":false,"_confidence":0.3},{"effect":"Contraindicated product administered","drugRate":"","severity":"serious","_validated":false,"_confidence":0.3},{"effect":"Joint swelling","drugRate":"","severity":"serious","_validated":false,"_confidence":0.3},{"effect":"Rheumatoid arthritis","drugRate":"","severity":"serious","_validated":false,"_confidence":0.3},{"effect":"Synovitis","drugRate":"","severity":"serious","_validated":false,"_confidence":0.3},{"effect":"Treatment failure","drugRate":"","severity":"serious","_validated":false,"_confidence":0.3},{"effect":"Arthropathy","drugRate":"","severity":"serious","_validated":false,"_confidence":0.3},{"effect":"Systemic lupus erythematosus","drugRate":"","severity":"serious","_validated":false,"_confidence":0.3},{"effect":"Therapeutic product effect decreased","drugRate":"","severity":"serious","_validated":false,"_confidence":0.3},{"effect":"Pemphigus","drugRate":"","severity":"serious","_validated":false,"_confidence":0.3},{"effect":"Alopecia","drugRate":"","severity":"serious","_validated":false,"_confidence":0.3},{"effect":"Hand deformity","drugRate":"","severity":"serious","_validated":false,"_confidence":0.3},{"effect":"Abdominal discomfort","drugRate":"","severity":"serious","_validated":false,"_confidence":0.3},{"effect":"Glossodynia","drugRate":"","severity":"serious","_validated":false,"_confidence":0.3}],"contraindications":["Alcoholism","Anemia","Anemia due to enzyme deficiency","Deficiency of glucose-6-phosphate dehydrogenase","Disease of liver","Disorder of eye","Disorder of macula of retina","Neutropenic disorder","Porphyria","Psoriasis","Retinal disorder","Visual field defect","Visual impairment"],"specialPopulations":{"Pregnancy":"Prolonged clinical experience over decades of use and available data from published epidemiologic and clinical studies with hydroxychloroquine sulfate use in pregnant women have not identified drug-associated risk of major birth defects, miscarriage, or adverse maternal, or fetal outcomes. There are risks to the mother and fetus associated with untreated or increased disease activity from malaria, rheumatoid arthritis, and systemic lupus erythematosus in pregnancy.","Geriatric use":"Clinical studies of hydroxychloroquine sulfate did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. However, this drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function.","Paediatric use":"Safety and efficacy have not been established in the chronic use of hydroxychloroquine sulfate for systemic lupus erythematosus and juvenile idiopathic arthritis in children. Children are especially sensitive to the 4-aminoquinoline compounds. Most reported fatalities followed the accidental ingestion of chloroquine, sometimes in small doses.","Renal impairment":"Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection and it may be used with caution in patients with renal impairment."}},"trials":[],"aliases":[],"company":"Advanz","patents":[],"pricing":[{"market":"United States","source":"CMS National Average Drug Acquisition Cost (NADAC)","asOfDate":"2024-01-03","unitCost":"$0.1448/EA","priceType":"NADAC","sourceUrl":"https://data.medicaid.gov/dataset/4j6z-xnwq","annualCost":"$53","description":"HYDROXYCHLOROQUINE 100 MG TAB","retrievedDate":"2026-04-07"}],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=HYDROXYCHLOROQUINE","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T03:32:30.710139+00:00"},"timeline":{"url":"https://en.wikipedia.org/wiki/Hydroxychloroquine","method":"deterministic","source":"Wikipedia","rawText":"","confidence":0.8,"sourceType":"wikipedia","retrievedAt":"2026-04-20T03:32:37.198398+00:00"},"aiSummary":{"url":"","method":"ai_extraction","source":"AI Strategic Summary","aiModel":"featherless","rawText":"","confidence":0.9,"sourceType":"ai_extraction","retrievedAt":"2026-04-20T03:33:06.985115+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T03:32:35.807734+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=HYDROXYCHLOROQUINE","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T03:32:36.121802+00:00"},"administration.route":{"url":"","method":"deterministic","source":"FDA Label","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T03:32:29.533194+00:00"},"indications.approved":{"url":"","method":"ai_extraction","source":"FDA Label + AI","aiModel":"featherless","rawText":"","confidence":0.9,"sourceType":"fda_label","retrievedAt":"2026-04-20T03:33:01.249162+00:00"},"safety.boxedWarnings":{"url":"","method":"deterministic","source":"FDA Label (no boxed warning)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T03:32:29.533225+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL1535/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T03:32:36.828487+00:00"},"regulatory.fda_application":{"url":"","method":"deterministic","source":"FDA Label","rawText":"ANDA040150","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T03:32:29.533230+00:00"}},"allNames":"hydroxychloroquine sulfate","offLabel":[],"synonyms":["hydroxychloroquine","hydroxychloroquine sulfate","oxichloroquine","oxychlorochin","oxychloroquine"],"timeline":[{"date":"1955-01-01","type":"neutral","source":"FDA Orange Book","milestone":"Rights transferred from SANOFI AVENTIS US to Advanz Pharma"},{"date":"1955-04-18","type":"positive","source":"DrugCentral","milestone":"FDA approval (Sanofi Aventis Us)"},{"date":"2020-04-07","type":"neutral","source":"FDA Orange Book","milestone":"Generic entry — 14 manufacturers approved"},{"date":"2022-01-14","type":"positive","source":"FDA Orange Book","milestone":"Sovuna approved — 200MG"}],"aiSummary":"Hydroxychloroquine Sulfate, marketed by Advanz, is an established antimalarial and anti-inflammatory agent with a key composition patent expiring in 2028. Its primary strength lies in its well-documented efficacy for treating uncomplicated malaria, supported by a long history of use. The primary risk is the presence of multiple off-patent competitors, including chloroquine and primaquine, which may erode market share.","approvals":[{"date":"1955-04-18","orphan":false,"company":"SANOFI AVENTIS US","regulator":"FDA"}],"brandName":"Hydroxychloroquine Sulfate","ecosystem":[{"indication":"Discoid lupus erythematosus","otherDrugs":[{"name":"alclometasone dipropionate","slug":"alclometasone-dipropionate","company":""},{"name":"amcinonide","slug":"amcinonide","company":"Astellas"},{"name":"betamethasone","slug":"betamethasone","company":""},{"name":"betamethasone benzoate","slug":"betamethasone-benzoate","company":"Parke Davis"}],"globalPrevalence":2400000},{"indication":"Falciparum malaria","otherDrugs":[{"name":"artesunate","slug":"artesunate","company":"Amivas"},{"name":"atovaquone","slug":"atovaquone","company":""},{"name":"chloroquine","slug":"chloroquine","company":"Sanofi Aventis Us"},{"name":"halofantrine","slug":"halofantrine","company":"Glaxosmithkline"}],"globalPrevalence":240000},{"indication":"Malaria Prevention","otherDrugs":[{"name":"chloroquine","slug":"chloroquine","company":"Sanofi Aventis Us"}],"globalPrevalence":240000},{"indication":"Ovale malaria","otherDrugs":[{"name":"chloroquine","slug":"chloroquine","company":"Sanofi Aventis Us"}],"globalPrevalence":240000},{"indication":"Plasmodium Falciparum Malaria Prevention","otherDrugs":[{"name":"atovaquone","slug":"atovaquone","company":""},{"name":"chloroquine","slug":"chloroquine","company":"Sanofi Aventis Us"},{"name":"proguanil","slug":"proguanil","company":"Glaxosmithkline"}],"globalPrevalence":240000},{"indication":"Plasmodium Malariae Malaria Prevention","otherDrugs":[{"name":"chloroquine","slug":"chloroquine","company":"Sanofi Aventis Us"}],"globalPrevalence":240000},{"indication":"Plasmodium Ovale Malaria Prevention","otherDrugs":[{"name":"chloroquine","slug":"chloroquine","company":"Sanofi Aventis Us"}],"globalPrevalence":240000},{"indication":"Quartan malaria","otherDrugs":[{"name":"chloroquine","slug":"chloroquine","company":"Sanofi Aventis Us"}],"globalPrevalence":240000}],"mechanism":{"target":"Toll-like receptor 9","novelty":"Follow-on","targets":[{"gene":"TLR9","source":"DrugCentral","target":"Toll-like receptor 9","protein":"Toll-like receptor 9"},{"gene":"SIGMAR1","source":"DrugCentral","target":"Sigma non-opioid intracellular receptor 1","protein":"Sigma non-opioid intracellular receptor 1"},{"gene":"TMEM97","source":"DrugCentral","target":"Transmembrane protein 97","protein":"Transmembrane protein 97"},{"gene":"CHRM2","source":"DrugCentral","target":"Muscarinic acetylcholine receptor M2","protein":"Muscarinic acetylcholine receptor M2"},{"gene":"ADRA1D","source":"DrugCentral","target":"Alpha-1D adrenergic receptor","protein":"Alpha-1D adrenergic receptor"},{"gene":"TLR7","source":"DrugCentral","target":"Toll-like receptor 7","protein":"Toll-like receptor 7"},{"gene":"CHRM3","source":"DrugCentral","target":"Muscarinic acetylcholine receptor M3","protein":"Muscarinic acetylcholine receptor M3"},{"gene":"CHRM4","source":"DrugCentral","target":"Muscarinic acetylcholine receptor M4","protein":"Muscarinic acetylcholine receptor M4"},{"gene":"ADRA2A","source":"DrugCentral","target":"Alpha-2A adrenergic receptor","protein":"Alpha-2A adrenergic receptor"},{"gene":"CHRM1","source":"DrugCentral","target":"Muscarinic acetylcholine receptor M1","protein":"Muscarinic acetylcholine receptor M1"}],"modality":"Small Molecule","drugClass":"Antimalarial","explanation":"Mechanism of action: The precise mechanism by which hydroxychloroquine exhibits activity against Plasmodium is not known. Hydroxychloroquine, like chloroquine, is weak base and may exert its effect by concentrating in the acid vesicles of the parasite and by inhibiting polymerization of heme. It can also inhibit certain enzymes by its interaction with DNA.","oneSentence":"Hydroxychloroquine Sulfate works by interfering with the replication of malaria parasites and reducing inflammation in the body.","technicalDetail":"Hydroxychloroquine Sulfate acts as an antimalarial agent by inhibiting the activity of heme polymerase, an enzyme essential for the survival of Plasmodium parasites, thereby preventing their replication and ultimately leading to their death.","_target_confidence":0.5},"_wikipedia":{"url":"https://en.wikipedia.org/wiki/Hydroxychloroquine","title":"Hydroxychloroquine","extract":"Hydroxychloroquine, sold under the brand name Plaquenil among others, is a medication used to prevent and treat malaria in areas where malaria remains sensitive to chloroquine. Other uses include treatment of rheumatoid arthritis, lupus, and porphyria cutanea tarda. It is taken by mouth, often in the form of hydroxychloroquine sulfate."},"commercial":{"launchDate":"1955","_launchSource":"DrugCentral (FDA 1955-04-18, SANOFI AVENTIS US)"},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/1395","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=HYDROXYCHLOROQUINE","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=HYDROXYCHLOROQUINE","fields":["publications"],"source":"PubMed/NCBI"},{"id":4,"url":"https://en.wikipedia.org/wiki/Hydroxychloroquine","fields":["history","overview"],"source":"Wikipedia"},{"id":5,"url":"https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files","fields":["patents","exclusivity","genericManufacturers"],"source":"FDA Orange Book"}],"_enrichedAt":"2026-03-30T11:58:01.829811","_validation":{"fieldsValidated":2,"lastValidatedAt":"2026-04-20T03:33:06.985706+00:00","fieldsConflicting":15,"overallConfidence":0.8},"biosimilars":[],"competitors":[{"drugName":"chloroquine","drugSlug":"chloroquine","fdaApproval":"1949-10-31","patentStatus":"Unknown","relationship":"same-class"},{"drugName":"primaquine","drugSlug":"primaquine","fdaApproval":"1952-01-23","genericCount":3,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"amodiaquine","drugSlug":"amodiaquine","fdaApproval":"","patentStatus":"Unknown","relationship":"same-class"},{"drugName":"tafenoquine","drugSlug":"tafenoquine","fdaApproval":"2018-07-20","patentExpiry":"Dec 2, 2035","patentStatus":"Patent protected","relationship":"same-class"}],"dataSources":[{"url":"https://data.medicaid.gov/dataset/4j6z-xnwq","name":"CMS National Average Drug Acquisition Cost (NADAC)","fields":["pricing"],"retrievedDate":"2026-04-07"}],"genericName":"hydroxychloroquine","indications":{"approved":[{"id":"hydroxychloroquine-uncomplicated-malaria-treatmen","name":"Uncomplicated malaria treatment","dosing":null,"approvals":[],"diseaseId":"","eligibility":"Adult and pediatric patients","pivotalTrial":null,"restrictions":[],"patientPopulation":"Adult and pediatric patients","diagnosticRequired":null,"brandNameForIndication":"Hydroxychloroquine Sulfate"},{"id":"hydroxychloroquine-malaria-prophylaxis","name":"Malaria prophylaxis","dosing":null,"approvals":[],"diseaseId":"","eligibility":"Adult and pediatric patients","pivotalTrial":null,"restrictions":[],"patientPopulation":"Adult and pediatric patients","diagnosticRequired":null,"brandNameForIndication":"Hydroxychloroquine Sulfate"},{"id":"hydroxychloroquine-rheumatoid-arthritis-treatment","name":"Rheumatoid arthritis treatment","dosing":null,"approvals":[],"diseaseId":"","eligibility":"Adults","pivotalTrial":null,"restrictions":[],"patientPopulation":"Adults","diagnosticRequired":null,"brandNameForIndication":"Hydroxychloroquine Sulfate"},{"id":"hydroxychloroquine-systemic-lupus-erythematosus-t","name":"Systemic lupus erythematosus treatment","dosing":null,"approvals":[],"diseaseId":"","eligibility":"Adults","pivotalTrial":null,"restrictions":[],"patientPopulation":"Adults","diagnosticRequired":null,"brandNameForIndication":"Hydroxychloroquine Sulfate"},{"id":"hydroxychloroquine-chronic-discoid-lupus-erythema","name":"Chronic discoid lupus erythematosus treatment","dosing":null,"approvals":[],"diseaseId":"","eligibility":"Adults","pivotalTrial":null,"restrictions":[],"patientPopulation":"Adults","diagnosticRequired":null,"brandNameForIndication":"Hydroxychloroquine Sulfate"}],"offLabel":[{"name":"Coronavirus infection","source":"DrugCentral","drugName":"HYDROXYCHLOROQUINE","evidenceCount":2729,"evidenceLevel":"strong"},{"name":"Hypercalcemia associated with Sarcoidosis","source":"DrugCentral","drugName":"HYDROXYCHLOROQUINE","evidenceCount":8,"evidenceLevel":"emerging"},{"name":"Juvenile rheumatoid arthritis","source":"DrugCentral","drugName":"HYDROXYCHLOROQUINE","evidenceCount":112,"evidenceLevel":"strong"},{"name":"Polymorphic light eruption","source":"DrugCentral","drugName":"HYDROXYCHLOROQUINE","evidenceCount":10,"evidenceLevel":"emerging"},{"name":"Porphyria cutanea tarda","source":"DrugCentral","drugName":"HYDROXYCHLOROQUINE","evidenceCount":59,"evidenceLevel":"strong"},{"name":"Q fever endocarditis","source":"DrugCentral","drugName":"HYDROXYCHLOROQUINE","evidenceCount":74,"evidenceLevel":"strong"},{"name":"Vasculitis of the skin","source":"DrugCentral","drugName":"HYDROXYCHLOROQUINE"}],"pipeline":[]},"currentOwner":"Advanz Pharma","drugCategory":"established","labelChanges":[],"patentStatus":"Off-patent — no active Orange Book patents","relatedDrugs":[{"drugId":"chloroquine","brandName":"chloroquine","genericName":"chloroquine","approvalYear":"1949","relationship":"same-class"},{"drugId":"primaquine","brandName":"primaquine","genericName":"primaquine","approvalYear":"1952","relationship":"same-class"},{"drugId":"amodiaquine","brandName":"amodiaquine","genericName":"amodiaquine","approvalYear":"","relationship":"same-class"},{"drugId":"tafenoquine","brandName":"tafenoquine","genericName":"tafenoquine","approvalYear":"2018","relationship":"same-class"}],"trialDetails":[{"nctId":"NCT01480154","phase":"PHASE1","title":"Akt Inhibitor MK2206 and Hydroxychloroquine in Treating Patients With Advanced Solid Tumors, Melanoma, Prostate or Kidney Cancer","status":"ACTIVE_NOT_RECRUITING","sponsor":"National Cancer Institute (NCI)","startDate":"2011-11-23","conditions":["Advanced Malignant Solid Neoplasm","Stage III Cutaneous Melanoma AJCC v7","Stage III Prostate Cancer AJCC v7","Stage III Renal Cell Cancer AJCC v7","Stage IIIA Cutaneous Melanoma AJCC v7","Stage IIIB Cutaneous Melanoma AJCC v7","Stage IIIC Cutaneous Melanoma AJCC v7","Stage IV Cutaneous Melanoma AJCC v6 and v7","Stage IV Prostate Cancer AJCC v7","Stage IV Renal Cell Cancer AJCC v7"],"enrollment":62,"completionDate":"2026-03-19"},{"nctId":"NCT07497282","phase":"PHASE2","title":"Venlafaxine as Adjunct Therapy in Rheumatoid Arthritis","status":"NOT_YET_RECRUITING","sponsor":"Ain Shams University","startDate":"2026-03-26","conditions":["Rheumatoid Arthritis"],"enrollment":70,"completionDate":"2026-12-26"},{"nctId":"NCT01145196","phase":"","title":"Genotype-Phenotype Study of Patients With Plaquenil -Induced Retinal Toxicity, With Evaluation of the ABCA4 Gene","status":"RECRUITING","sponsor":"National Eye Institute (NEI)","startDate":"2010-08-23","conditions":["Genotype","Retinal Disease"],"enrollment":320,"completionDate":""},{"nctId":"NCT05942911","phase":"PHASE2","title":"Safety and Effect on Pain and Function According to RAPID-3 of IHL-675A in Patients With Rheumatoid Arthritis","status":"TERMINATED","sponsor":"Incannex Healthcare Ltd","startDate":"2023-11-22","conditions":["Rheumatoid Arthritis"],"enrollment":20,"completionDate":"2025-10-28"},{"nctId":"NCT07343635","phase":"NA","title":"The Efficacy and Safety of Anti-inflammation Treatment (Hirudoid Introduction Followed by Yellow Light Therapy) Combined With Tofacitinib and Doxycycline in Chinese Adult Patients With Mild to Moderate Erythematous Telangiectatic Rosacea","status":"RECRUITING","sponsor":"The Fourth Affiliated Hospital of Zhejiang University School of Medicine","startDate":"2026-02-01","conditions":["Erythematotelangiectatic Rosacea"],"enrollment":186,"completionDate":"2027-07-01"},{"nctId":"NCT03822780","phase":"NA","title":"Hydroxychloroquin (HCQ) in chILD of Genetic Defect","status":"COMPLETED","sponsor":"Children's Hospital of Fudan University","startDate":"2017-07-01","conditions":["Surfactant Dysfunction"],"enrollment":25,"completionDate":"2026-03-15"},{"nctId":"NCT04678648","phase":"PHASE1","title":"A Trial of RSC-1255 for Treatment of Patients With Advanced Malignancies","status":"RECRUITING","sponsor":"RasCal Therapeutics, Inc.","startDate":"2021-03-03","conditions":["Advanced Malignant Solid Neoplasm","RAS Mutation","Lung Cancer","Colon Cancer","Glioblastoma","Pancreatic Cancer"],"enrollment":134,"completionDate":"2027-01-30"},{"nctId":"NCT04532346","phase":"EARLY_PHASE1","title":"Hydroxychloroquine in Children's Interstitial Lung Diseases With Genetic Causes","status":"RECRUITING","sponsor":"Children's Hospital of Fudan University","startDate":"2024-09-01","conditions":["Interstitial Lung Disease","Surfactant Dysfunction"],"enrollment":60,"completionDate":"2027-04"},{"nctId":"NCT07467252","phase":"PHASE2","title":"AIPH-TB: AI-Optimised Pyrazinamide-Hydroxychloroquine vs Standard RIPE for Drug-Sensitive Pulmonary Tuberculosis - A Phase II RCT","status":"NOT_YET_RECRUITING","sponsor":"Ministry of Health, Saudi Arabia","startDate":"2026-09","conditions":["Pulmonary Tuberculosis"],"enrollment":200,"completionDate":"2028-06"},{"nctId":"NCT04527549","phase":"PHASE2","title":"Testing Dabrafenib and Trametinib With or Without Hydroxychloroquine in Stage IIIC or IV BRAF V600E/K Melanoma","status":"TERMINATED","sponsor":"ECOG-ACRIN Cancer Research Group","startDate":"2021-06-01","conditions":["Clinical Stage IV Cutaneous Melanoma AJCC v8","Locally Advanced Melanoma","Pathologic Stage IIIC Cutaneous Melanoma AJCC v8","Pathologic Stage IV Cutaneous Melanoma AJCC v8","Unresectable Melanoma"],"enrollment":5,"completionDate":"2024-01-08"},{"nctId":"NCT07280741","phase":"PHASE4","title":"Recombinant Herpes Zoster Vaccine in Patients With Autoimmune Rheumatic Diseases Under Immunomodulators","status":"RECRUITING","sponsor":"University of Sao Paulo General Hospital","startDate":"2025-12-02","conditions":["Autoimmune Rheumatic Diseases"],"enrollment":200,"completionDate":"2028-07-30"},{"nctId":"NCT05016297","phase":"PHASE2","title":"Efficacy and Safety of Baricitinib in Sjogren's Syndrome","status":"COMPLETED","sponsor":"Peking Union Medical College Hospital","startDate":"2022-07-14","conditions":["Sjogren's Syndrome"],"enrollment":87,"completionDate":"2024-11-22"},{"nctId":"NCT06037811","phase":"PHASE2","title":"Early Adalimumab Induction for Immune Checkpoint Inhibitor Associated Inflammatory Arthritis","status":"RECRUITING","sponsor":"Tom Appleton","startDate":"2024-04-15","conditions":["Inflammatory Arthritis","Immune-related Adverse Event"],"enrollment":30,"completionDate":"2028-12"},{"nctId":"NCT07443436","phase":"PHASE2","title":"Immunomodulatory Treatment of Interstitial Lung Disease Associated With Surfactant Related Gene Variants","status":"NOT_YET_RECRUITING","sponsor":"Assistance Publique - Hôpitaux de Paris","startDate":"2026-10-01","conditions":["Interstitial Lung Disease"],"enrollment":30,"completionDate":"2027-10-01"},{"nctId":"NCT04937907","phase":"PHASE2","title":"Study of Hydroxychloroquine in Patients With X-linked Alport Syndrome in China (CHXLAS)","status":"COMPLETED","sponsor":"Shanghai Children's Hospital","startDate":"2021-09-08","conditions":["Alport Syndrome, X-Linked"],"enrollment":50,"completionDate":"2024-12-31"},{"nctId":"NCT05799378","phase":"PHASE3","title":"Effects of Stopping Hydroxychloroquine in Elderly Lupus Disease","status":"RECRUITING","sponsor":"NYU Langone Health","startDate":"2024-06-27","conditions":["Systemic Lupus Erythematosus"],"enrollment":330,"completionDate":"2029-06-30"},{"nctId":"NCT05041907","phase":"PHASE2","title":"Finding Treatments for COVID-19: A Trial of Antiviral Pharmacodynamics in Early Symptomatic COVID-19 (PLATCOV)","status":"RECRUITING","sponsor":"University of Oxford","startDate":"2021-09-30","conditions":["COVID-19"],"enrollment":3800,"completionDate":"2027-01"},{"nctId":"NCT05894954","phase":"PHASE3","title":"Precision Medicine Approach for Early Dementia & Mild Cognitive Impairment","status":"COMPLETED","sponsor":"Alzheimer's Prevention and Reversal Project, Inc.","startDate":"2023-07-31","conditions":["Mild Cognitive Impairment","Dementia, Mild"],"enrollment":73,"completionDate":"2026-02-09"},{"nctId":"NCT06915701","phase":"PHASE2,PHASE3","title":"\"Effect of Vitamin E (α-Tocopherol) on Clinical Activity and Inflammation in Rheumatoid Arthritis\"","status":"RECRUITING","sponsor":"University of Guadalajara","startDate":"2026-02-06","conditions":["Rheumatoid Arthritis"],"enrollment":46,"completionDate":"2027-01-15"},{"nctId":"NCT05782335","phase":"","title":"Analysis of T and B Cell Repertoire Changes in Response to Orencia® (Abatacept) in Rheumatoid Arthritis","status":"RECRUITING","sponsor":"Hospital for Special Surgery, New York","startDate":"2022-11-01","conditions":["Rheumatoid Arthritis"],"enrollment":72,"completionDate":"2026-12"},{"nctId":"NCT07409740","phase":"","title":"Optical Coherence Tomography Angiography Evaluation Of Patients Taking Hydroxychloroquine","status":"NOT_YET_RECRUITING","sponsor":"Sohag University","startDate":"2026-02-01","conditions":["Hydroxychloroquine Retinopathy"],"enrollment":90,"completionDate":"2026-09-01"},{"nctId":"NCT04345692","phase":"PHASE3","title":"A Randomized Controlled Clinical Trial: Hydroxychloroquine for the Treatment of COVID-19 in Hospitalized Patients","status":"TERMINATED","sponsor":"Queen's Medical Center","startDate":"2020-03-26","conditions":["COVID-19"],"enrollment":17,"completionDate":"2020-08-31"},{"nctId":"NCT02595346","phase":"PHASE2","title":"Study of the Efficiency of Hydroxychloroquine on the Endothelial Dysfunction and Its Vascular Consequences During the Antiphospholipid Syndrome","status":"COMPLETED","sponsor":"University Hospital, Rouen","startDate":"2016-05-17","conditions":["Antiphospholipid Syndrome (APS)"],"enrollment":25,"completionDate":"2020-08-05"},{"nctId":"NCT06408298","phase":"EARLY_PHASE1","title":"HCQ in Resectable Localized Prostate Cancer","status":"RECRUITING","sponsor":"Lionel.D.Lewis, MD","startDate":"2026-01-06","conditions":["Resectable Localized Prostate Cancer"],"enrollment":20,"completionDate":"2029-03"},{"nctId":"NCT03598595","phase":"PHASE1,PHASE2","title":"Gemcitabine, Docetaxel, and Hydroxychloroquine in Treating Participants With Recurrent or Refractory Osteosarcoma","status":"ACTIVE_NOT_RECRUITING","sponsor":"M.D. Anderson Cancer Center","startDate":"2019-01-28","conditions":["Recurrent Osteosarcoma","Refractory Osteosarcoma"],"enrollment":31,"completionDate":"2026-05-31"},{"nctId":"NCT04201457","phase":"PHASE1,PHASE2","title":"A Trial of Dabrafenib, Trametinib and Hydroxychloroquine for Patients With Recurrent LGG or HGG With a BRAF Aberration","status":"ACTIVE_NOT_RECRUITING","sponsor":"Pediatric Brain Tumor Consortium","startDate":"2020-01-17","conditions":["Low Grade Glioma (LGG) of Brain With BRAF Aberration","High Grade Glioma (HGG) of the Brain With BRAF Aberration","Low Grade Glioma of Brain With Neurofibromatosis Type 1"],"enrollment":57,"completionDate":"2026-03-31"},{"nctId":"NCT05306353","phase":"PHASE2","title":"CD40L Antagonism in Rheumatoid Arthritis (RA)","status":"TERMINATED","sponsor":"National Institute of Allergy and Infectious Diseases (NIAID)","startDate":"2023-07-25","conditions":["Rheumatoid Arthritis"],"enrollment":2,"completionDate":"2025-07-28"},{"nctId":"NCT07077486","phase":"PHASE4","title":"Effects of Telitacicept vs Cyclophosphamide on Lupus Related Interstitial Lung Disease","status":"RECRUITING","sponsor":"Tongji Hospital","startDate":"2025-08-25","conditions":["Lupus or SLE","Interstitial Lung Disease","Systemic Lupus Erythematosus"],"enrollment":100,"completionDate":"2027-03-25"},{"nctId":"NCT04524702","phase":"PHASE2","title":"Paricalcitol and Hydroxychloroquine in Combination With Gemcitabine and Nab-Paclitaxel for Advanced Pancreatic Cancer","status":"COMPLETED","sponsor":"Emory University","startDate":"2020-09-14","conditions":["Advanced Pancreatic Adenocarcinoma","Metastatic Pancreatic Adenocarcinoma","Stage IV Pancreatic Cancer AJCC v8"],"enrollment":10,"completionDate":"2023-06-06"},{"nctId":"NCT05842174","phase":"PHASE1,PHASE2","title":"Targeting Ischemia-Induced Autophagy Dependence in Hepatocellular Carcinoma","status":"NOT_YET_RECRUITING","sponsor":"VA Office of Research and Development","startDate":"2026-02-01","conditions":["Hepatocellular Carcinoma"],"enrollment":93,"completionDate":"2030-10-15"},{"nctId":"NCT07352566","phase":"PHASE4","title":"Utilization of a Microdevice for Psoriasis and Atopic Dermatitis","status":"NOT_YET_RECRUITING","sponsor":"University of California, San Francisco","startDate":"2026-01-01","conditions":["Psoriasis","Atopic Dermatitis"],"enrollment":10,"completionDate":"2030-06-01"},{"nctId":"NCT07294872","phase":"PHASE1","title":"A Study of TIL in Advanced Solid Tumors (CZ)","status":"NOT_YET_RECRUITING","sponsor":"Shanghai Juncell Therapeutics","startDate":"2026-05-08","conditions":["Solid Tumor, Adult"],"enrollment":30,"completionDate":"2029-09-20"},{"nctId":"NCT03481881","phase":"","title":"Pharmacokinetics of Drugs Administered to Children","status":"RECRUITING","sponsor":"Duke University","startDate":"2013-08-14","conditions":["Pediatric ALL"],"enrollment":200,"completionDate":"2033-08-14"},{"nctId":"NCT06776445","phase":"PHASE1","title":"Efficacy and Safety of Different Dose Regimens of Gabapentin for Treating Erythema/Flushing in Rosacea: A Randomized Controlled Trial","status":"COMPLETED","sponsor":"First Affiliated Hospital of Chongqing Medical University","startDate":"2024-01-05","conditions":["Rosacea","Rosacea Subtype 1 (Erythematotelangiectatic)"],"enrollment":50,"completionDate":"2025-07-31"},{"nctId":"NCT05671497","phase":"PHASE2,PHASE3","title":"The Effect of Cilostazol on Rheumatoid Arthritis Patients","status":"COMPLETED","sponsor":"Ain Shams University","startDate":"2022-11-01","conditions":["Rheumatoid Arthritis"],"enrollment":70,"completionDate":"2024-10-01"},{"nctId":"NCT06161363","phase":"","title":"Description of Compliance With Hydroxychloroquine Treatment in Patients With Systemic Lupus Erythematosus","status":"COMPLETED","sponsor":"University Hospital, Toulouse","startDate":"2023-11-27","conditions":["Lupus Erythematosus"],"enrollment":102,"completionDate":"2024-12-16"},{"nctId":"NCT06828328","phase":"EARLY_PHASE1","title":"A Study of GC203 TIL in PDCA (RJ)","status":"RECRUITING","sponsor":"Shanghai Juncell Therapeutics","startDate":"2025-02-10","conditions":["Pancreatic Cancer","Pancratic Ductal Adenocarcinoma","Treatment Side Effects","Tumor Infiltrating Lymphocytes"],"enrollment":10,"completionDate":"2028-01-31"},{"nctId":"NCT04960072","phase":"EARLY_PHASE1","title":"A Study of GC101 TIL in r/r Gastrointestinal Tumors (10hospital)","status":"RECRUITING","sponsor":"Shanghai Juncell Therapeutics","startDate":"2021-06-30","conditions":["Gastrointestinal Tumor"],"enrollment":50,"completionDate":"2026-07-30"},{"nctId":"NCT06971744","phase":"PHASE2","title":"Autophagy Maintenance (AUTOMAIN)","status":"RECRUITING","sponsor":"Medical University of South Carolina","startDate":"2025-12-18","conditions":["Ovarian Cancer"],"enrollment":38,"completionDate":"2029-06-18"},{"nctId":"NCT06488950","phase":"EARLY_PHASE1","title":"A Study of TIL in Advanced Solid Tumors (DFGD)","status":"RECRUITING","sponsor":"Shanghai Juncell Therapeutics","startDate":"2023-04-01","conditions":["Advanced Solid Tumor","Tumor Infiltrating Lymphocytes","Treatment Side Effects","Effects of Immunotherapy"],"enrollment":30,"completionDate":"2027-06-30"},{"nctId":"NCT04943913","phase":"EARLY_PHASE1","title":"Study of GC101 TIL in Brain Glioma (Soochow2)","status":"RECRUITING","sponsor":"Shanghai Juncell Therapeutics","startDate":"2021-05-06","conditions":["Glioma"],"enrollment":50,"completionDate":"2027-05-31"},{"nctId":"NCT04967833","phase":"EARLY_PHASE1","title":"A Study of GC101 TIL in Advanced Solid Tumors (TR)","status":"RECRUITING","sponsor":"Shanghai Juncell Therapeutics","startDate":"2021-04-22","conditions":["Advanced Solid Tumors"],"enrollment":20,"completionDate":"2026-04-22"},{"nctId":"NCT05098171","phase":"EARLY_PHASE1","title":"A Study of GC201 TIL in Advanced Gynecologic Tumors (10hospital)","status":"RECRUITING","sponsor":"Shanghai Juncell Therapeutics","startDate":"2021-09-26","conditions":["Advanced Gynecologic Tumors","Signal Switch Receptor Modified TIL","Treatment Side Effects","Effects of Immunotherapy"],"enrollment":50,"completionDate":"2027-09-25"},{"nctId":"NCT05142475","phase":"EARLY_PHASE1","title":"A Study of GC101 TIL in Advanced Breast Cancer (10hospital)","status":"RECRUITING","sponsor":"Shanghai Juncell Therapeutics","startDate":"2021-11-19","conditions":["Breast Cancer","Treatment Side Effects","Advanced Breast Cancer","Effects of Immunotherapy"],"enrollment":50,"completionDate":"2027-12-20"},{"nctId":"NCT05098197","phase":"EARLY_PHASE1","title":"A Study of GC101 TIL in Advanced Hepatobiliary-Pancreatic Cancers (10hospital)","status":"RECRUITING","sponsor":"Shanghai Juncell Therapeutics","startDate":"2021-09-26","conditions":["Advanced Liver Cancers","Tumor Infiltrating Lymphocyte","Treatment Side Effects","Effects of Immunotherapy","Advanced Pancreatic Cancers"],"enrollment":50,"completionDate":"2026-09-25"},{"nctId":"NCT05098184","phase":"EARLY_PHASE1","title":"A Study of GC101 TIL in Advanced Melanoma (10hospital)","status":"RECRUITING","sponsor":"Shanghai Juncell Therapeutics","startDate":"2021-09-26","conditions":["Advanced Melanoma","Tumor Infiltrating Lymphocyte","Treatment Side Effects","Effects of Immunotherapy"],"enrollment":50,"completionDate":"2026-09-25"},{"nctId":"NCT05843188","phase":"PHASE2","title":"Study of Hydroxychloroquine With FOLFIRI and Bevacizumab in DTP-high Metastatic Colorectal Cancer","status":"ACTIVE_NOT_RECRUITING","sponsor":"University Health Network, Toronto","startDate":"2023-08-09","conditions":["Metastatic Colorectal Cancer"],"enrollment":155,"completionDate":"2026-10-24"},{"nctId":"NCT07265297","phase":"PHASE3","title":"Using Hydroxychloroquine (HCQ) to Treat Steatohepatitis","status":"RECRUITING","sponsor":"National Taiwan University Hospital","startDate":"2025-08-12","conditions":["Steatohepatitis, Nonalcoholic"],"enrollment":210,"completionDate":"2030-12-31"},{"nctId":"NCT02615938","phase":"PHASE2","title":"Hydroxychloroquine (HCQ) in Pediatric Interstitial Lung Disease (ILD)","status":"TERMINATED","sponsor":"Matthias Griese","startDate":"2015-08-21","conditions":["Interstitial Lung Disease","Diffuse Parenchymal Lung Disease","Children´s Interstitial Lung Disease"],"enrollment":35,"completionDate":"2020-09-09"},{"nctId":"NCT04702256","phase":"PHASE3","title":"Induction Therapy for Lupus Nephritis With no Added Oral Steroids: A Trial Comparing Oral Corticosteroids Plus Mycophenolate Mofetil (MMF) Versus Obinutuzumab and MMF","status":"RECRUITING","sponsor":"Assistance Publique - Hôpitaux de Paris","startDate":"2021-12-09","conditions":["Lupus Nephritis","Systemic Lupus Erythematosus (SLE)"],"enrollment":196,"completionDate":"2031-12"},{"nctId":"NCT04344379","phase":"PHASE3","title":"Prevention of SARS-CoV-2 in Hospital Workers s Exposed to the Virus","status":"COMPLETED","sponsor":"Assistance Publique - Hôpitaux de Paris","startDate":"2020-04-17","conditions":["SARS-CoV-2 Infection"],"enrollment":122,"completionDate":"2020-06-18"},{"nctId":"NCT06083688","phase":"PHASE4","title":"Preventing Malaria in School Children to Protect the Whole Community in Rural Blantyre District, Malawi","status":"ACTIVE_NOT_RECRUITING","sponsor":"Liverpool School of Tropical Medicine","startDate":"2024-10-14","conditions":["Malaria,Falciparum","Anemia in Children"],"enrollment":1000,"completionDate":"2026-01"},{"nctId":"NCT07230028","phase":"PHASE4","title":"Doxycycline Boosted Therapy in Lyme Borreliosis: DoBo Study.","status":"NOT_YET_RECRUITING","sponsor":"Radboud University Medical Center","startDate":"2026-03-01","conditions":["Lyme Borreliosis, Nervous System"],"enrollment":50,"completionDate":"2027-11-01"},{"nctId":"NCT04132505","phase":"PHASE1","title":"Binimetinib and Hydroxychloroquine in Treating Patients With KRAS Mutant Metastatic Pancreatic Cancer","status":"ACTIVE_NOT_RECRUITING","sponsor":"M.D. Anderson Cancer Center","startDate":"2019-10-22","conditions":["Metastatic Pancreatic Adenocarcinoma","Stage IV Pancreatic Cancer AJCC v8"],"enrollment":39,"completionDate":"2026-12-31"},{"nctId":"NCT04787991","phase":"PHASE1","title":"Exploratory Platform Trial to Evaluate Immunotherapy Combinations With Chemotherapy for the Treatment of Patients With Previously Untreated Metastatic Pancreatic Adenocarcinoma","status":"COMPLETED","sponsor":"Cancer Insight, LLC","startDate":"2021-08-09","conditions":["Metastatic Pancreatic Adenocarcinoma"],"enrollment":45,"completionDate":"2025-07-31"},{"nctId":"NCT05576896","phase":"PHASE2","title":"Hydroxychloroquine in Combination With Encorafenib and Cetuximab or Panitumumab in the Treatment of Metastatic BRAF-mutated Colorectal Cancer Refractory","status":"RECRUITING","sponsor":"Northwestern University","startDate":"2022-10-10","conditions":["Stage IV Colorectal Cancer Positive for BRAF V600E Mutation","Colorectal Cancer","Colorectal Cancer Stage IV"],"enrollment":43,"completionDate":"2028-07-01"},{"nctId":"NCT00977470","phase":"PHASE2","title":"Erlotinib With or Without Hydroxychloroquine in Chemo-Naive Advanced NSCLC and (EGFR) Mutations","status":"ACTIVE_NOT_RECRUITING","sponsor":"Massachusetts General Hospital","startDate":"2009-10","conditions":["Non-small Cell Lung Cancer"],"enrollment":76,"completionDate":"2027-12"},{"nctId":"NCT05036226","phase":"PHASE1,PHASE2","title":"COAST Therapy in Advanced Solid Tumors and Prostate Cancer","status":"RECRUITING","sponsor":"Medical University of South Carolina","startDate":"2022-03-03","conditions":["Prostate Cancer Recurrent","Solid Tumor, Adult"],"enrollment":76,"completionDate":"2027-05-21"},{"nctId":"NCT07190534","phase":"","title":"The Effectiveness of Hydroxychloroquine Versus Methotrexate in the Treatment of Frontal Fibrosing Alopecia in Routine Clinical Care: a Patient Preference Trial (FFA Trial)","status":"NOT_YET_RECRUITING","sponsor":"Erasmus Medical Center","startDate":"2025-11","conditions":["Frontal Fibrosing Alopecia","Cicatricial Alopecia"],"enrollment":50,"completionDate":"2027-05"},{"nctId":"NCT04007562","phase":"","title":"Acute Rhabdomyolysis and Muscle Pain Associated With Mutations in the LPIN1 Gene - A Retrospective Study Describing the Safety and Efficacy of Hydroxychloroquine Sulfate Given on a Compassionate Basis to Patients Suffering From Lipin-1 Deficiency","status":"WITHDRAWN","sponsor":"Assistance Publique - Hôpitaux de Paris","startDate":"2019-11-04","conditions":["LIPIN1 Deficiency"],"enrollment":0,"completionDate":"2019-11-04"},{"nctId":"NCT05221320","phase":"PHASE2","title":"Trial of Ulixertinib in Combination With Hydroxychloroquine in Patients With Advanced Gastrointestinal (GI) Malignancies","status":"TERMINATED","sponsor":"BioMed Valley Discoveries, Inc","startDate":"2022-05-26","conditions":["Tumor, Solid","Gastrointestinal Cancer"],"enrollment":47,"completionDate":"2024-07-14"},{"nctId":"NCT04333654","phase":"PHASE1","title":"Hydroxychloroquine in Outpatient Adults With COVID-19","status":"TERMINATED","sponsor":"Sanofi","startDate":"2020-04-12","conditions":["Coronavirus Infection"],"enrollment":8,"completionDate":"2020-05-26"},{"nctId":"NCT06652113","phase":"NA","title":"Effect of HCQ Combined With LT4 on LBR in Euthyroid Women With URPL and TPO-Ab","status":"RECRUITING","sponsor":"Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University","startDate":"2024-11-15","conditions":["Recurrent Pregnancy Loss","Euthyroid With Thyroid Antibodies"],"enrollment":796,"completionDate":"2037-03"},{"nctId":"NCT05279027","phase":"EARLY_PHASE1","title":"Zr89 + PET Companion Trial","status":"COMPLETED","sponsor":"Abramson Cancer Center at Penn Medicine","startDate":"2022-03-08","conditions":["Melanoma (Skin)"],"enrollment":6,"completionDate":"2025-05-06"},{"nctId":"NCT01284725","phase":"PHASE3","title":"Weaning of Immunosuppression in Nephritis of Lupus","status":"COMPLETED","sponsor":"Assistance Publique Hopitaux De Marseille","startDate":"2011-02-16","conditions":["Nephritis of Lupus"],"enrollment":100,"completionDate":"2018-12-31"},{"nctId":"NCT03030118","phase":"PHASE2","title":"Study of Anti-Malarials in Incomplete Lupus Erythematosus","status":"COMPLETED","sponsor":"Milton S. Hershey Medical Center","startDate":"2017-12-28","conditions":["Systemic Lupus Erythematosus"],"enrollment":187,"completionDate":"2024-06-30"},{"nctId":"NCT05841758","phase":"PHASE4","title":"Hydroxychloroquine as a Steroid-sparing Agent in Extrapulmonary Sarcoidosis","status":"RECRUITING","sponsor":"Hospices Civils de Lyon","startDate":"2024-07-30","conditions":["Sarcoidosis, Pulmonary"],"enrollment":140,"completionDate":"2029-07-01"},{"nctId":"NCT04397328","phase":"PHASE3","title":"COVID-19 PEP- High-risk Individuals in Long-term and Specialized Care - Canada","status":"WITHDRAWN","sponsor":"London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's","startDate":"2020-05-30","conditions":["COVID-19"],"enrollment":0,"completionDate":"2021-04-30"},{"nctId":"NCT03037437","phase":"PHASE2","title":"Sorafenib Induced Autophagy Using Hydroxychloroquine in Hepatocellular Cancer","status":"COMPLETED","sponsor":"The University of Texas Health Science Center at San Antonio","startDate":"2017-02-16","conditions":["Hepatocellular Cancer"],"enrollment":64,"completionDate":"2025-06-27"},{"nctId":"NCT07138898","phase":"PHASE2","title":"Immunosuppressant Management in Rheumatology Patients Undergoing Elective Total Shoulder Arthroplasty","status":"NOT_YET_RECRUITING","sponsor":"NYU Langone Health","startDate":"2025-09","conditions":["Rheumatic Disease"],"enrollment":80,"completionDate":"2027-09"},{"nctId":"NCT07021495","phase":"","title":"SKIN Disease Profiling by an Exploratory, pRospective, Biomarker Study in dermatoloGY Practice (SKINERGY)","status":"RECRUITING","sponsor":"Leiden University Medical Center","startDate":"2025-07-29","conditions":["Chronic Spontaneous Urticaria (CSU)","Hidradenitis Suppurativa (HS)","Psoriasis (PsO)","Atopic Dermatitis (AD)","CTCL/ Mycosis Fungoides"],"enrollment":840,"completionDate":"2029-12-31"},{"nctId":"NCT04669197","phase":"PHASE2","title":"Study of Paclitaxel Protein Bound + Gemcitabine + Cisplatin + Hydrochloroquine as Treatment in Untreated Pancreas Cancer","status":"ACTIVE_NOT_RECRUITING","sponsor":"HonorHealth Research Institute","startDate":"2020-12-01","conditions":["Untreated Resectable Pancreatic Adenocarcinoma","Borderline Resectable Pancreatic Adenocarcinoma","Locally Advanced Pancreatic Adenocarcinoma"],"enrollment":19,"completionDate":"2025-12-30"},{"nctId":"NCT07013110","phase":"PHASE2","title":"An Artificial Intelligence-powered Approach to Precision Immunotherapy of Human Arthritis","status":"RECRUITING","sponsor":"Prof Salvatore Albani","startDate":"2025-06-18","conditions":["Rheumatoid Arthritis (RA)","Rheumatology"],"enrollment":124,"completionDate":"2028-11"},{"nctId":"NCT03414502","phase":"PHASE3","title":"Treatment of Rheumatoid Arthritis With DMARDs: Predictors of Response","status":"RECRUITING","sponsor":"University of Nebraska","startDate":"2007-12-10","conditions":["Rheumatoid Arthritis"],"enrollment":400,"completionDate":"2029-03"},{"nctId":"NCT06035887","phase":"","title":"Novel ERG for Detection of Hydroxychloroquine Retinopathy","status":"RECRUITING","sponsor":"King's College Hospital NHS Trust","startDate":"2024-05-31","conditions":["Hydroxychloroquine Retinopathy"],"enrollment":140,"completionDate":"2026-05"},{"nctId":"NCT01506973","phase":"PHASE1,PHASE2","title":"A Study of Hydroxychloroquine in Combination With Gemcitabine/Abraxane in Pancreatic Cancer","status":"COMPLETED","sponsor":"Abramson Cancer Center at Penn Medicine","startDate":"2011-12","conditions":["Advanced Adenocarcinoma","Metastatic Adenocarcinoma"],"enrollment":119,"completionDate":"2022-03"},{"nctId":"NCT03377179","phase":"PHASE2","title":"A Study of ABC294640 Alone and in Combination With HCQ Sulfate in the Treatment of Advanced Cholangiocarcinoma","status":"COMPLETED","sponsor":"RedHill Biopharma Limited","startDate":"2018-03-07","conditions":["Cholangiocarcinoma","Cholangiocarcinoma Non-resectable","Cholangiocarcinoma, Perihilar","Cholangiocarcinoma, Extrahepatic","Cholangiocarcinoma, Intrahepatic"],"enrollment":65,"completionDate":"2022-06-21"},{"nctId":"NCT03032406","phase":"PHASE2","title":"CLEVER Pilot Trial: A Phase II Pilot Trial of HydroxyChLoroquine, EVErolimus or the Combination for Prevention of Recurrent Breast Cancer","status":"ACTIVE_NOT_RECRUITING","sponsor":"Abramson Cancer Center at Penn Medicine","startDate":"2017-01-23","conditions":["Breast Cancer Stage IIB"],"enrollment":53,"completionDate":"2026-01-01"},{"nctId":"NCT06676384","phase":"PHASE4","title":"Which of the Commonly Available and Approved Drugs in Addition to Standard of Care Can Significantly Improve the Slope of Estimated Glomerular Filtration Rate at Two Years When Compared to Standard of Care Alone in South-Asian Kidney Biopsy-proven Adult (≥18 Years) Primary IgA Nephropathy?","status":"RECRUITING","sponsor":"Christian Medical College, Vellore, India","startDate":"2025-02-15","conditions":["IgA Nephropathy","Renal Insufficiency, Chronic","IgA Vasculitis","IGA Glomerulonephritis"],"enrollment":585,"completionDate":"2029-08"},{"nctId":"NCT07061717","phase":"PHASE3","title":"Comparing Endocrine Therapy Combined With High-Dose Palbociclib and Hydroxychloroquine to Endocrine Therapy Combined With Standard-Dose Palbociclib for Hormone Receptor-Positive and HER2-Negative Advanced Breast Cancer","status":"NOT_YET_RECRUITING","sponsor":"Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University","startDate":"2025-07-01","conditions":["Hormone Receptor-Positive and HER2-Negative Advanced Breast Cancer"],"enrollment":474,"completionDate":"2029-07-01"},{"nctId":"NCT04464759","phase":"PHASE1,PHASE2","title":"A Study of Nivolumab and Hydroxychloroquine or Nivolumab/Ipilimumab and Hydroxychloroquine in Advanced Melanoma","status":"RECRUITING","sponsor":"Ravi Amaravadi, MD","startDate":"2020-10-21","conditions":["Melanoma"],"enrollment":94,"completionDate":"2025-10-30"},{"nctId":"NCT04354649","phase":"PHASE2","title":"Immune-Mediated Pathophysiology And Clinical Triage Program","status":"RECRUITING","sponsor":"AHS Cancer Control Alberta","startDate":"2021-09-16","conditions":["Arthritis","Arthralgia"],"enrollment":46,"completionDate":"2029-07"},{"nctId":"NCT02603146","phase":"PHASE2","title":"Strategy to Prevent the Onset of Clinically-Apparent Rheumatoid Arthritis","status":"TERMINATED","sponsor":"National Institute of Allergy and Infectious Diseases (NIAID)","startDate":"2016-04-27","conditions":["Healthy Participants","Rheumatoid Arthritis (RA) Prevention"],"enrollment":144,"completionDate":"2022-11-01"},{"nctId":"NCT06319560","phase":"NA","title":"Hydroxychloroquine in Type 2 Diabetes During Pregnancy","status":"RECRUITING","sponsor":"National University of Malaysia","startDate":"2024-03-24","conditions":["Diabetes in Pregnancy","Type 2 Diabetes"],"enrollment":56,"completionDate":"2027-01-01"},{"nctId":"NCT04335084","phase":"PHASE2","title":"A Study of Hydroxychloroquine, Vitamin C, Vitamin D, and Zinc for the Prevention of COVID-19 Infection","status":"COMPLETED","sponsor":"ProgenaBiome","startDate":"2020-06-22","conditions":["COVID-19","Coronavirus Infection","Sars-CoV2","Corona Virus Infection","COVID","Coronavirus","Coronavirus-19","Coronavirus 19"],"enrollment":254,"completionDate":"2024-04-11"},{"nctId":"NCT06350630","phase":"PHASE2","title":"Therapeutic Effect of Hydroxychloroquine on Immunoglobulin A (IgA) Nephropathy Course QUIgAN Study","status":"NOT_YET_RECRUITING","sponsor":"Centre Hospitalier Universitaire de Saint Etienne","startDate":"2025-06","conditions":["IgA Nephropathy"],"enrollment":334,"completionDate":"2030-12-31"},{"nctId":"NCT03979651","phase":"NA","title":"MEK and Autophagy Inhibition in Metastatic/Locally Advanced, Unresectable Neuroblastoma RAS (NRAS) Melanoma","status":"COMPLETED","sponsor":"Hospices Civils de Lyon","startDate":"2019-10-15","conditions":["Metastatic NRAS Melanoma"],"enrollment":29,"completionDate":"2023-01-03"},{"nctId":"NCT04379492","phase":"PHASE2","title":"A Study of Hydroxycholoroquine Compared to Placebo as Treatment for People With COVID-19","status":"WITHDRAWN","sponsor":"Memorial Sloan Kettering Cancer Center","startDate":"2020-05-05","conditions":["COVID-19","COVID19","Sars-CoV2","SARS-Cov-2"],"enrollment":0,"completionDate":"2020-09-25"},{"nctId":"NCT05998759","phase":"PHASE2","title":"Telitacicept for the Treatment of Connective Tissue Disease-associated Thrombocytopenia","status":"RECRUITING","sponsor":"Beijing Hospital","startDate":"2023-12-02","conditions":["Connective Tissue Diseases","Thrombocytopenia"],"enrollment":296,"completionDate":"2025-12"},{"nctId":"NCT06949982","phase":"PHASE2","title":"Efficacy And Safety Of Hydroxychloroquine Combined With Methotrexate, Capecitabine And Bevacizumab Vs. Regorafenib In Participants With Refractory Metastatic Colorectal Cancer With Mutations In RAS Genes","status":"RECRUITING","sponsor":"Sergey Orlov, MD","startDate":"2025-03-17","conditions":["Metastatic Colorectal Cancer (mCRC)","Colorectal Neoplasms"],"enrollment":60,"completionDate":"2027-10"},{"nctId":"NCT06939582","phase":"PHASE1,PHASE2","title":"Hydroxychloroquine Sulfate Tablets for Radiation-induced Oral Mucositis","status":"RECRUITING","sponsor":"Xingchen Peng","startDate":"2024-12-22","conditions":["Radiation-induced Oral Mucositis"],"enrollment":158,"completionDate":"2025-06-20"},{"nctId":"NCT06020378","phase":"","title":"Hydroxychloroquine May be Beneficial for Preeclampsia","status":"ACTIVE_NOT_RECRUITING","sponsor":"RenJi Hospital","startDate":"2024-01-01","conditions":["Pre-Eclampsia"],"enrollment":462,"completionDate":"2026-12-01"},{"nctId":"NCT05630989","phase":"","title":"A Registry to Capture Patient Outcomes With KRAS G12R Altered Advanced Pancreatic Ductal Adenocarcinoma Treated With MEK Inhibitor-based Combination Therapy","status":"RECRUITING","sponsor":"Mandana Kamgar, MD","startDate":"2023-02-07","conditions":["Pancreatic Ductal Adenocarcinoma"],"enrollment":80,"completionDate":"2027-08-01"},{"nctId":"NCT05365893","phase":"EARLY_PHASE1","title":"PHL Treatment in Pancreatic Cancer","status":"RECRUITING","sponsor":"Fox Chase Cancer Center","startDate":"2021-10-20","conditions":["Pancreatic Ductal Adenocarcinoma"],"enrollment":20,"completionDate":"2026-12-31"},{"nctId":"NCT03825289","phase":"PHASE1","title":"Trametinib and Hydroxychloroquine in Treating Patients With Pancreatic Cancer","status":"ACTIVE_NOT_RECRUITING","sponsor":"University of Utah","startDate":"2019-01-18","conditions":["Metastatic Pancreatic Carcinoma","Stage II Pancreatic Cancer","Stage IIA Pancreatic Cancer","Stage IIB Pancreatic Cancer","Stage III Pancreatic Cancer","Stage IV Pancreatic Cancer","Unresectable Pancreatic Carcinoma"],"enrollment":25,"completionDate":"2029-03"},{"nctId":"NCT05083780","phase":"PHASE1","title":"Hydroxychloroquine and Chlorphenesin Carbamate in Combination With mFOLFIRINOX in Pancreatic Cancer","status":"ACTIVE_NOT_RECRUITING","sponsor":"Changhoon Yoo","startDate":"2021-11-30","conditions":["Pancreatic Cancer"],"enrollment":40,"completionDate":"2026-12-30"},{"nctId":"NCT04011410","phase":"PHASE2","title":"Hydroxychloroquine to Increase Tumor Suppressor PAR-4 Levels in Oligometastatic Prostate Cancer","status":"COMPLETED","sponsor":"Patrick Hensley","startDate":"2019-12-03","conditions":["Prostate Cancer Recurrent"],"enrollment":20,"completionDate":"2024-03-08"},{"nctId":"NCT06887517","phase":"","title":"Chinese Rheumatism Biobank(CRB)","status":"RECRUITING","sponsor":"Chinese SLE Treatment And Research Group","startDate":"2025-02-10","conditions":["Lupus Erythematosus, Systemic"],"enrollment":300,"completionDate":"2033-04-01"},{"nctId":"NCT04523857","phase":"PHASE2","title":"ABemacicliB or Abemaciclib and HydroxYchloroquine to Target Minimal Residual Disease in Breast Cancer","status":"RECRUITING","sponsor":"Abramson Cancer Center at Penn Medicine","startDate":"2021-11-01","conditions":["Breast Cancer"],"enrollment":66,"completionDate":"2028-12"},{"nctId":"NCT04735068","phase":"PHASE2","title":"Binimetinib and Hydroxychloroquine in Patients With Advanced KRAS Mutant Non-Small Cell Lung Cancer","status":"COMPLETED","sponsor":"Abramson Cancer Center at Penn Medicine","startDate":"2021-04-09","conditions":["Non-Small Cell Lung Cancer","KRAS Mutation-Related Tumors"],"enrollment":9,"completionDate":"2023-12-31"}],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"administration":{"route":"Oral","formulation":"Tablet","formulations":[{"form":"TABLET","route":"ORAL","productName":"HYDROXYCHLOROQUINE SULFATE"},{"form":"TABLET","route":"ORAL","productName":"HYDROXYCHLOROQUINE SULFATEfilm coated"},{"form":"TABLET","route":"ORAL","productName":"Hydroxychloroquine Sulfate"},{"form":"TABLET","route":"ORAL","productName":"Hydroxychloroquine sulfate"},{"form":"TABLET","route":"ORAL","productName":"Plaquenil"},{"form":"TABLET","route":"ORAL","productName":"Hydroxychloroquine Sulfate"},{"form":"TABLET","route":"ORAL","productName":"Hydroxychloroquine Sulfate"},{"form":"TABLET, FILM COATED","route":"ORAL","productName":"Hydroxychloroquine Sulfate"},{"form":"TABLET, FILM COATED","route":"ORAL","productName":"Hydroxychloroquine sulfate"},{"form":"TABLET, FILM COATED","route":"ORAL","productName":"Hydroxychloroquinesulfate"},{"form":"TABLET, FILM COATED","route":"ORAL","productName":"Hydroxychloroquine Sulfate"}]},"_patentsChecked":true,"crossReferences":{"NUI":"N0000147871","MMSL":"15082","NDDF":"002949","UNII":"4QWG6N8QKH","VUID":"4019780","CHEBI":"CHEBI:5801","VANDF":"4018253","INN_ID":"796","RXNORM":"153972","UMLSCUI":"C0020336","chemblId":"CHEMBL1535","ChEMBL_ID":"CHEMBL1535","KEGG_DRUG":"D02114","DRUGBANK_ID":"DB01611","PUBCHEM_CID":"3652","SNOMEDCT_US":"13502005","IUPHAR_LIGAND_ID":"7198","SECONDARY_CAS_RN":"747-36-4","MESH_DESCRIPTOR_UI":"D006886"},"formularyStatus":[],"_enricherVersion":"v2","_offLabelChecked":true,"developmentCodes":[],"ownershipHistory":[{"period":"1955-","companyName":"Sanofi","relationship":"Original Developer"},{"period":"present","companyName":"Advanz Pharma","relationship":"Current Owner"}],"pharmacokinetics":{"source":"DrugCentral","halfLife":"850.0 hours","clearance":"11.0 mL/min/kg","bioavailability":"74%","fractionUnbound":"0.57%","volumeOfDistribution":"700.0 L/kg"},"publicationCount":10833,"therapeuticAreas":["Immunology"],"atcClassification":{"source":"DrugCentral","atcCode":"P01BA02","allCodes":["P01BA02"]},"biosimilarFilings":[],"originalDeveloper":"Sanofi Aventis Us","recentPublications":[{"date":"2026 Mar 27","pmid":"41894261","title":"Lupus erythematosus-specific bullous lesions: A case report.","journal":"Medicine"},{"date":"2026 Mar 27","pmid":"41891412","title":"Late-Onset Sjögren disease: A different clinical entity?","journal":"Sarcoidosis, vasculitis, and diffuse lung diseases : official journal of WASOG"},{"date":"2026 Apr 1","pmid":"41889659","title":"Treatment patterns of biologic disease-modifying anti-rheumatic drugs in juvenile idiopathic arthritis: a population-based study in Korea.","journal":"Journal of rheumatic diseases"},{"date":"2026","pmid":"41884851","title":"Immune profiling-informed immunomodulation associated with gestational extension in early-onset preeclampsia with monochorionic twins: a case report.","journal":"Frontiers in immunology"},{"date":"2026 Mar 25","pmid":"41883149","title":"Cumulative defined daily doses enables objective assessment of treatment intensity and outcome prediction in immunoglobulin G4-related disease and its subtypes.","journal":"Rheumatology (Oxford, England)"}],"companionDiagnostics":[],"genericManufacturers":15,"_genericFilersChecked":true,"genericManufacturerList":["Accord Hlthcare","Alkaloida Zrt","Amneal Pharms Co","Appco","Aurobindo Pharma Usa","Chartwell Rx","Creekwood Pharms","Hikma Pharms","Ipca Labs Ltd","Laurus","Sandoz","Senores Pharms","Teva Pharms","Watson Labs","Zydus Pharms Usa Inc"],"status":"approved","companyName":"Advanz Pharma","companyId":"advanz","modality":"Small molecule","firstApprovalDate":"1955","enrichmentLevel":4,"visitCount":0,"regulatoryByCountry":[{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"1955-04-18T00:00:00.000Z","mah":"SANOFI AVENTIS US","brand_name_local":null,"application_number":""},{"country_code":"CA","regulator":"Health Canada","status":"approved","approval_date":null,"mah":"","brand_name_local":"","application_number":""},{"country_code":"IL","regulator":"MOH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"SG","regulator":"HSA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AE","regulator":"MOH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"KR","regulator":"MFDS","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AU","regulator":"TGA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"GB","regulator":"MHRA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null}],"trialStats":{"total":40,"withResults":10},"validation":{"fieldsValidated":2,"lastValidatedAt":"2026-04-20T03:33:06.985706+00:00","fieldsConflicting":15,"overallConfidence":0.8},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}