{"id":"albendazole","rwe":[{"pmid":"41891658","year":"2026","title":"Albendazole loaded chitosan nanoparticle conjugated with hyaluronic acid for the treatment of psoriasis.","finding":"","journal":"Drug development and industrial pharmacy","studyType":"Clinical Study"},{"pmid":"41890581","year":"2026","title":"Discovery of novel repurposed anthelminthics against Trichinella spiralis and albendazole-resistant nematodes through metabolomics-guided virtual screening.","finding":"","journal":"Current research in parasitology & vector-borne diseases","studyType":"Clinical Study"},{"pmid":"41884195","year":"2026","title":"Palliative Management of Advanced Breast Carcinoma Complicated by Myiasis: First Case Report From Bangladesh.","finding":"","journal":"Clinical medicine insights. Case reports","studyType":"Clinical Study"},{"pmid":"41882045","year":"2026","title":"Unveiling of phytochemicals, antioxidants, cytotoxic effects and anthelmintic potency of green tea (Camellia sinensis) beverage against albendazole resistant Hamonchus contortus.","finding":"","journal":"Scientific reports","studyType":"Clinical Study"},{"pmid":"41877881","year":"2026","title":"Calcified frontal neurocysticercosis presenting with acute psychosis in a non-endemic context: a case report.","finding":"","journal":"Frontiers in psychiatry","studyType":"Clinical Study"}],"_fda":{"id":"2da2a777-2835-429d-b73a-31b8e0bde571","set_id":"06b5eefc-0b95-4862-b9b6-770063f2adf0","openfda":{"nui":["N0000175481","N0000191624"],"upc":["0301151701496"],"unii":["F4216019LN"],"route":["ORAL"],"rxcui":["199672"],"spl_id":["2da2a777-2835-429d-b73a-31b8e0bde571"],"brand_name":["Albendazole"],"spl_set_id":["06b5eefc-0b95-4862-b9b6-770063f2adf0"],"package_ndc":["0115-1701-49"],"product_ndc":["0115-1701"],"generic_name":["ALBENDAZOLE"],"product_type":["HUMAN PRESCRIPTION DRUG"],"substance_name":["ALBENDAZOLE"],"pharm_class_epc":["Anthelmintic [EPC]"],"pharm_class_moa":["Cytochrome P450 1A Inducers [MoA]"],"manufacturer_name":["Amneal Pharmaceuticals of New York LLC"],"application_number":["NDA020666"],"is_original_packager":[true]},"version":"9","pregnancy":["8.1 Pregnancy Risk Summary There are limited data on use of albendazole in pregnant women to inform a drug-associated risk of major birth defects and miscarriage. In published studies, single-dose albendazole exposure during pregnancy did not show evidence of an increased risk of adverse maternal or fetal outcomes; however, this finding cannot be extrapolated to multiple-dose exposures ( see Data ). In animal reproductive studies, oral administration of albendazole during gestation caused embryotoxicity and skeletal malformations in pregnant rats (at oral doses of 0.10 times and 0.32 times the recommended human dose based on body surface area in mg/m 2 ) and pregnant rabbits (at oral doses of 0.60 times the recommended human dose based on body surface area in mg/m 2 ). Albendazole was also associated with maternal toxicity in rabbits (at doses of 0.60 times the recommended human dose based on body surface area in mg/m 2 ) ( see Data ). Albendazole should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Albendazole should not be used in pregnant women except in clinical circumstances where no alternative management is appropriate. If a patient becomes pregnant while taking this drug, albendazole should be discontinued immediately. If pregnancy occurs while taking this drug, the patient should be apprised of the potential hazard to the fetus. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Human Data A Cochrane review could not provide sufficient evidence of the impact of antihelminthics (including albendazole) on the pregnancy outcomes of low birthweight, perinatal mortality and preterm birth. In a large trial of about 2507 women, albendazole use during the second or third trimester of pregnancy had no overall effect on birth weight, perinatal mortality, or congenital anomalies. With a limited sample size and single-does exposure, another study could not rule out a two-fold increased risk of major malformations [4.7% vs. 2.2%; OR 2.2 (95% confidence interval (CI) 0.5 to 10.1); p = 0.26]. Animal Data Albendazole has been shown to be teratogenic (to cause embryotoxicity and skeletal malformations) in pregnant rats and rabbits. The teratogenic response in the rat was shown at oral doses of 10 and 30 mg/kg/day (0.10 times and 0.32 times the recommended human dose based on body surface area in mg/m 2 , respectively) during gestation days 6 to 15 and in pregnant rabbits at oral doses of 30 mg/kg/day (0.60 times the recommended human dose based on body surface area in mg/m 2 ) administered during gestation days 7 to 19. In the rabbit study, maternal toxicity (33% mortality) was noted at 30 mg/kg/day. In mice, no teratogenic effects were observed at oral doses up to 30 mg/kg/day (0.16 times the recommended human dose based on body surface area in mg/m 2 ), administered during gestation days 6 to 15."],"overdosage":["10 OVERDOSAGE In case of overdosage, symptomatic therapy and general supportive measures are recommended."],"description":["11 DESCRIPTION Albendazole is an orally administered anthelmintic drug. Chemically, it is methyl 5-(propylthio)-2-benzimidazolecarbamate. Its molecular formula is C 12 H 15 N 3 O 2 S. Its molecular weight is 265.34. It has the following chemical structure: Albendazole is a white to yellowish powder. It is freely soluble in anhydrous formic acid and very slightly soluble in ether and in methylene chloride. Albendazole is practically insoluble in alcohol and in water. Each white to off-white, circular, biconvex, bevel-edged film coated, TILTAB tablet is debossed with “ap” and “550” and contains 200 mg of albendazole. Inactive ingredients consist of: carnauba wax, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, sodium lauryl sulfate, sodium saccharin, sodium starch glycolate, and starch. methyl 5-(propylthio)-2-benzimidazolecarbamate"],"how_supplied":["16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied Each white to off-white, circular, biconvex, bevel-edged film coated, TILTAB tablet is debossed with “ap” and “550” and contains 200 mg of albendazole. Bottles of 2 Tablets NDC 0115-1701-49 16.2 Storage and Handling Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].","16.1 How Supplied Each white to off-white, circular, biconvex, bevel-edged film coated, TILTAB tablet is debossed with “ap” and “550” and contains 200 mg of albendazole. Bottles of 2 Tablets NDC 0115-1701-49"],"geriatric_use":["8.5 Geriatric Use In patients aged 65 and older with either hydatid disease or neurocysticercosis, there was insufficient data to determine whether the safety and effectiveness of albendazole is different from that of younger patients."],"pediatric_use":["8.4 Pediatric Use Hydatid disease is uncommon in infants and young children. In neurocysticercosis, the efficacy of albendazole in children appears to be similar to that in adults."],"effective_time":"20190930","nursing_mothers":["8.3 Females and Males of Reproductive Potential Pregnancy Testing Obtain pregnancy test prior to prescribing albendazole to women of reproductive potential. Contraception Females Advise women of reproductive potential to use effective birth control for the duration of albendazole therapy and for one month after end of therapy."],"pharmacokinetics":["12.3 Pharmacokinetics Absorption Albendazole is poorly absorbed from the gastrointestinal tract due to its low aqueous solubility. Albendazole concentrations are negligible or undetectable in plasma as it is rapidly converted to the sulfoxide metabolite prior to reaching the systemic circulation. The systemic anthelmintic activity has been attributed to the primary metabolite, albendazole sulfoxide. Oral bioavailability appears to be enhanced when albendazole is coadministered with a fatty meal (estimated fat content 40 grams) as evidenced by higher (up to 5-fold on average) plasma concentrations of albendazole sulfoxide as compared to the fasted state. Maximal plasma concentrations of albendazole sulfoxide were achieved 2 hours to 5 hours after dosing and were on average 1310 ng/mL (range 460 ng/mL to 1580 ng/mL) following oral doses of albendazole (400 mg) in 6 hydatid disease patients, when administered with a fatty meal. Plasma concentrations of albendazole sulfoxide increased in a dose-proportional manner over the therapeutic dose range following ingestion of a high-fat meal (fat content 43.1 grams). The mean apparent terminal elimination half-life of albendazole sulfoxide ranged from 8 hours to 12 hours in 25 healthy subjects, as well as in 14 hydatid and 8 neurocysticercosis patients. Following 4 weeks of treatment with albendazole (200 mg three times daily), 12 patients’ plasma concentrations of albendazole sulfoxide were approximately 20% lower than those observed during the first half of the treatment period, suggesting that albendazole may induce its own metabolism. Distribution Albendazole sulfoxide is 70% bound to plasma protein and is widely distributed throughout the body; it has been detected in urine, bile, liver, cyst wall, cyst fluid, and cerebrospinal fluid (CSF). Concentrations in plasma were 3-fold to 10-fold and 2-fold to 4-fold higher than those simultaneously determined in cyst fluid and CSF, respectively. Metabolism and Excretion Albendazole is rapidly converted in the liver to the primary metabolite, albendazole sulfoxide, which is further metabolized to albendazole sulfone and other primary oxidative metabolites that have been identified in human urine. Following oral administration, albendazole has not been detected in human urine. Urinary excretion of albendazole sulfoxide is a minor elimination pathway with less than 1% of the dose recovered in the urine. Biliary elimination presumably accounts for a portion of the elimination as evidenced by biliary concentrations of albendazole sulfoxide similar to those achieved in plasma. Specific Populations Pediatrics Following single-dose administration of 200 mg to 300 mg (approximately 10 mg/kg) albendazole to 3 fasted and 2 fed pediatric patients with hydatid cyst disease (age range 6 to 13 years), albendazole sulfoxide pharmacokinetics were similar to those observed in fed adults. Geriatrics Although no studies have investigated the effect of age on albendazole sulfoxide pharmacokinetics, data in 26 hydatid cyst patients (up to 79 years) suggest pharmacokinetics similar to those in young healthy subjects."],"adverse_reactions":["6 ADVERSE REACTIONS Adverse reactions 1% or greater in hydatid disease: abnormal liver function tests, abdominal pain, nausea/vomiting, reversible alopecia, headache, dizziness/vertigo, fever. ( 6.1 ) Adverse reactions 1% or greater in neurocysticercosis: headache, nausea/vomiting, raised intracranial pressure, meningeal signs. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Amneal Pharmaceuticals at 1-877-835-5472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The adverse reaction profile of albendazole differs between hydatid disease and neurocysticercosis. Adverse reactions occurring with a frequency of 1% or greater in either disease are described in Table 2 below. These symptoms were usually mild and resolved without treatment. Treatment discontinuations were predominantly due to leukopenia (0.7%) or hepatic abnormalities (3.8% in hydatid disease). The following incidence reflects adverse reactions that were reported to be at least possibly or probably related to albendazole. T able 2: Adverse Reaction Incidence 1% or Greater in Hydatid Disease and Neurocysticercosis A dverse Reaction H ydatid Disease N eurocysticercosis G astrointestinal Abdominal Pain 6 0 Nausea 4 6 Vomiting 4 6 G eneral disorders and administration site conditions Fever 1 0 Investigations Elevated Hepatic Enzymes 16 less than 1 N ervous system disorders Dizziness 1 less than 1 Headache 1 11 Meningeal Signs 0 1 Raised Intracranial Pressure 0 2 Vertigo 1 less than 1 Skin and subcutaneous tissue disorders Reversible Alopecia 2 less than 1 The following adverse events were observed at an incidence of less than 1%: Blood and Lymphatic System Disorders: There have been reports of leukopenia, granulocytopenia, pancytopenia, agranulocytosis, or thrombocytopenia [see Warnings and Precautions (5.1) ] . Immune System Disorders: Hypersensitivity reactions, including rash and urticaria. 6.2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of albendazole. 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: Aplastic anemia, bone marrow suppression, neutropenia. Eye Disorders: Vision blurred. Gastrointestinal Disorders: Diarrhea. General System Disorders: Asthenia. Hepatobiliary Disorders: Elevations of hepatic enzymes, hepatitis, acute liver failure. Musculoskeletal and Connective Tissue Disorders: Rhabdomyolysis. Nervous System Disorders: Somnolence, convulsion. Renal and Urinary Disorders: Acute renal failure. Skin and Subcutaneous Tissue Disorders: Erythema multiforme, Stevens-Johnson syndrome."],"contraindications":["4 CONTRAINDICATIONS Albendazole is contraindicated in patients with known hypersensitivity to the benzimidazole class of compounds or any components of albendazole. Patients with known hypersensitivity to the benzimidazole class of compounds or any components of albendazole."],"drug_interactions":["7 DRUG INTERACTIONS Dexamethasone: Steady-state trough concentrations of albendazole sulfoxide were about 56% higher when dexamethasone was coadministered with each dose of albendazole. ( 7.1 ) Praziquantel: In the fed state increased mean maximum plasma concentration and area under the curve of albendazole sulfoxide by about 50% in healthy subjects. ( 7.2 ) Cimetidine: Increased albendazole sulfoxide concentrations in bile and cystic fluid by about 2-fold in hydatid cyst patients. ( 7.3 ) Theophylline: Albendazole induces cytochrome P450 1A in human hepatoma cells; therefore, it is recommended that plasma concentrations of theophylline be monitored during and after treatment. ( 5.5 , 7.4 ) 7.1 Dexamethasone Steady-state trough concentrations of albendazole sulfoxide were about 56% higher when 8 mg dexamethasone was co-administered with each dose of albendazole (15 mg/kg/day) in 8 neurocysticercosis patients. 7.2 Praziquantel In the fed state, praziquantel (40 mg/kg) increased mean maximum plasma concentration and area under the curve of albendazole sulfoxide by about 50% in healthy subjects (n = 10) compared with a separate group of subjects (n = 6) given albendazole alone. Mean T max and mean plasma elimination half-life of albendazole sulfoxide were unchanged. The pharmacokinetics of praziquantel were unchanged following co-administration with albendazole (400 mg). 7.3 Cimetidine Albendazole sulfoxide concentrations in bile and cystic fluid were increased (about 2-fold) in hydatid cyst patients treated with cimetidine (10 mg/kg/day) (n = 7) compared with albendazole (20 mg/kg/day) alone (n = 12). Albendazole sulfoxide plasma concentrations were unchanged 4 hours after dosing. 7.4 Theophylline Following a single dose of albendazole (400 mg), the pharmacokinetics of theophylline (aminophylline 5.8 mg/kg infused over 20 minutes) were unchanged. Albendazole induces cytochrome P450 1A in human hepatoma cells; therefore, it is recommended that plasma concentrations of theophylline be monitored during and after treatment."],"mechanism_of_action":["12.1 Mechanism of Action Albendazole is a synthetic, antihelminthic drug of the class benzimidazole [see Clinical Pharmacology (12.4) ] ."],"teratogenic_effects":["5.2 Embryo-fetal Toxicity Albendazole may cause fetal harm and should not be used in pregnant women except in clinical circumstances where no alternative management is appropriate. Obtain pregnancy test prior to prescribing albendazole to women of reproductive potential. Advise women of reproductive potential to use effective birth control for the duration of albendazole therapy and for one month after end of therapy. Immediately discontinue albendazole if a patient becomes pregnant and apprise the patient of the potential hazard to the fetus [see Use in Specific Populations (8.1 , 8.3 )] ."],"storage_and_handling":["16.2 Storage and Handling Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]."],"clinical_pharmacology":["12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action Albendazole is a synthetic, antihelminthic drug of the class benzimidazole [see Clinical Pharmacology (12.4) ] . 12.3 Pharmacokinetics Absorption Albendazole is poorly absorbed from the gastrointestinal tract due to its low aqueous solubility. Albendazole concentrations are negligible or undetectable in plasma as it is rapidly converted to the sulfoxide metabolite prior to reaching the systemic circulation. The systemic anthelmintic activity has been attributed to the primary metabolite, albendazole sulfoxide. Oral bioavailability appears to be enhanced when albendazole is coadministered with a fatty meal (estimated fat content 40 grams) as evidenced by higher (up to 5-fold on average) plasma concentrations of albendazole sulfoxide as compared to the fasted state. Maximal plasma concentrations of albendazole sulfoxide were achieved 2 hours to 5 hours after dosing and were on average 1310 ng/mL (range 460 ng/mL to 1580 ng/mL) following oral doses of albendazole (400 mg) in 6 hydatid disease patients, when administered with a fatty meal. Plasma concentrations of albendazole sulfoxide increased in a dose-proportional manner over the therapeutic dose range following ingestion of a high-fat meal (fat content 43.1 grams). The mean apparent terminal elimination half-life of albendazole sulfoxide ranged from 8 hours to 12 hours in 25 healthy subjects, as well as in 14 hydatid and 8 neurocysticercosis patients. Following 4 weeks of treatment with albendazole (200 mg three times daily), 12 patients’ plasma concentrations of albendazole sulfoxide were approximately 20% lower than those observed during the first half of the treatment period, suggesting that albendazole may induce its own metabolism. Distribution Albendazole sulfoxide is 70% bound to plasma protein and is widely distributed throughout the body; it has been detected in urine, bile, liver, cyst wall, cyst fluid, and cerebrospinal fluid (CSF). Concentrations in plasma were 3-fold to 10-fold and 2-fold to 4-fold higher than those simultaneously determined in cyst fluid and CSF, respectively. Metabolism and Excretion Albendazole is rapidly converted in the liver to the primary metabolite, albendazole sulfoxide, which is further metabolized to albendazole sulfone and other primary oxidative metabolites that have been identified in human urine. Following oral administration, albendazole has not been detected in human urine. Urinary excretion of albendazole sulfoxide is a minor elimination pathway with less than 1% of the dose recovered in the urine. Biliary elimination presumably accounts for a portion of the elimination as evidenced by biliary concentrations of albendazole sulfoxide similar to those achieved in plasma. Specific Populations Pediatrics Following single-dose administration of 200 mg to 300 mg (approximately 10 mg/kg) albendazole to 3 fasted and 2 fed pediatric patients with hydatid cyst disease (age range 6 to 13 years), albendazole sulfoxide pharmacokinetics were similar to those observed in fed adults. Geriatrics Although no studies have investigated the effect of age on albendazole sulfoxide pharmacokinetics, data in 26 hydatid cyst patients (up to 79 years) suggest pharmacokinetics similar to those in young healthy subjects. 12.4 Microbiology Mechanism of Action Albendazole binds to the colchicine-sensitive site of β-tubulin inhibiting their polymerization into microtubules. The decrease in microtubules in the intestinal cells of the parasites decreases their absorptive function, especially the uptake of glucose by the adult and larval forms of the parasites, and also depletes glycogen storage. Insufficient glucose results in insufficient energy for the production of adenosine trisphosphate (ATP) and the parasite eventually dies. Mechanism of Resistance Parasitic resistance to albendazole is caused by changes in amino acids that result in changes in the β-tubulin protein. This causes reduced binding of the drug to β-tubulin. In the specified treatment indications albendazole appears to be active against the larval forms of the following organisms: Echinococcus granulosus Taenia solium"],"indications_and_usage":["1 INDICATIONS AND USAGE Albendazole is an anthelmintic drug indicated for: Treatment of parenchymal neurocysticercosis due to active lesions caused by larval forms of the pork tapeworm, Taenia solium . ( 1.1 ) Treatment of cystic hydatid disease of the liver, lung, and peritoneum, caused by the larval form of the dog tapeworm, Echinococcus granulosus . ( 1.2 ) 1.1 Neurocysticercosis Albendazole is indicated for the treatment of parenchymal neurocysticercosis due to active lesions caused by larval forms of the pork tapeworm, Taenia solium . 1.2 Hydatid Disease Albendazole is indicated for the treatment of cystic hydatid disease of the liver, lung, and peritoneum, caused by the larval form of the dog tapeworm, Echinococcus granulosus ."],"warnings_and_cautions":["5 WARNINGS AND PRECAUTIONS Bone Marrow Suppression: Fatalities have been reported due to bone marrow suppression; monitor blood counts in all patients at the beginning of each 28-day cycle of therapy, and every 2 weeks while on therapy. Discontinue albendazole if clinically significant changes in blood counts occur. ( 5.1 , 5.4 ) Embryo-fetal Toxicity: Obtain pregnancy test in women of reproductive potential prior to therapy and avoid usage in pregnant women except in clinical circumstances where no alternative management is appropriate. Discontinue therapy if pregnancy occurs and apprise patient of potential hazard to the fetus. ( 5.2 ) Risk of Neurologic Symptoms: Neurocysticercosis patients may experience cerebral hypertensive episodes, seizures or focal neurologic deficits after initiation of therapy; begin appropriate steroid and anticonvulsant therapy. ( 5.3 ) Risk of Retinal Damage in Retinal Cysticercosis: Cases of retinal involvement have been reported; examine the patient for the presence of retinal lesions before initiating therapy for neurocysticercosis. ( 5.4 ) Hepatic Effects. Elevations of liver enzymes may occur. Monitor liver enzymes before the start of each treatment cycle and at least every 2 weeks while on albendazole therapy and discontinue if clinically significant elevations occur. ( 5.5 ) 5.1 Bone Marrow Suppression Fatalities associated with the use of albendazole have been reported due to granulocytopenia or pancytopenia. Albendazole may cause bone marrow suppression, aplastic anemia, and agranulocytosis. Monitor blood counts at the beginning of each 28-day cycle of therapy, and every 2 weeks while on therapy with albendazole in all patients. Patients with liver disease and patients with hepatic echinococcosis are at increased risk for bone marrow suppression and warrant more frequent monitoring of blood counts. Discontinue albendazole if clinically significant decreases in blood cell counts occur. 5.2 Embryo-fetal Toxicity Albendazole may cause fetal harm and should not be used in pregnant women except in clinical circumstances where no alternative management is appropriate. Obtain pregnancy test prior to prescribing albendazole to women of reproductive potential. Advise women of reproductive potential to use effective birth control for the duration of albendazole therapy and for one month after end of therapy. Immediately discontinue albendazole if a patient becomes pregnant and apprise the patient of the potential hazard to the fetus [see Use in Specific Populations (8.1 , 8.3 )] . 5.3 Risk of Neurologic Symptoms in Neurocysticercosis Patients being treated for neurocysticercosis should receive steroid and anticonvulsant therapy to prevent neurological symptoms (e.g. seizures, increased intracranial pressure and focal signs) as a result of an inflammatory reaction caused by death of the parasite within the brain. 5.4 Risk of Retinal Damage in Patients with Retinal Neurocysticercosis Cysticercosis may involve the retina. Before initiating therapy for neurocysticercosis, examine the patient for the presence of retinal lesions. If such lesions are visualized, weigh the need for anticysticeral therapy against the possibility of retinal damage resulting from inflammatory damage caused by albendazole-induced death of the parasite. 5.5 Hepatic Effects In clinical trials, treatment with albendazole has been associated with mild to moderate elevations of hepatic enzymes in approximately 16% of patients. These elevations have generally returned to normal upon discontinuation of therapy. There have also been case reports of acute liver failure of uncertain causality and hepatitis [see Adverse Reactions (6) ] . Monitor liver enzymes (transaminases) before the start of each treatment cycle and at least every 2 weeks during treatment. If hepatic enzymes exceed twice the upper limit of normal, consideration should be given to discontinuing albendazole therapy based on individual patient circumstances. Restarting albendazole treatment in patients whose hepatic enzymes have normalized off treatment is an individual decision that should take into account the risk/benefit of further albendazole usage. Perform laboratory tests frequently if albendazole treatment is restarted. Patients with elevated liver enzyme test results are at increased risk for hepatotoxicity and bone marrow suppression [see Warnings and Precautions (5.1) ] . Discontinue therapy if liver enzymes are significantly increased or if clinically significant decreases in blood cell counts occur. 5.6 Unmasking of Neurocysticercosis in Hydatid Patients Undiagnosed neurocysticercosis may be uncovered in patients treated with albendazole for other conditions. Patients with epidemiologic factors who are at risk for neurocysticercosis should be evaluated prior to initiation of therapy."],"nonclinical_toxicology":["13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term carcinogenicity studies were conducted in mice and rats. No evidence of increased incidence of tumors was found in the mice or rats at up to 400 mg/kg/day or 20 mg/kg/day respectively (2 times and 0.2 times the recommended human dose on a body surface area basis). In genotoxicity tests, albendazole was found negative in an Ames Salmonella/Microsome Plate mutation assay, Chinese Hamster Ovary chromosomal aberration test, and in vivo mouse micronucleus test. In the in vitro BALB/3T3 cells transformation assay, albendazole produced weak activity in the presence of metabolic activation while no activity was found in the absence of metabolic activation. Albendazole did not adversely affect male or female fertility in the rat at an oral dose of 30 mg/kg/day (0.32 times the recommended human dose based on body surface area in mg/m 2 )."],"adverse_reactions_table":["<table width=\"100%\" cellspacing=\"0\" cellpadding=\"0\" border=\"0\"><col width=\"1pt\"/><col width=\"1pt\"/><col width=\"1pt\"/><tbody><tr><td styleCode=\" Toprule Lrule Rrule\"><paragraph><content styleCode=\"bold\">A</content><content styleCode=\"bold\">dverse Reaction</content></paragraph></td><td styleCode=\" Toprule Lrule Rrule\"><paragraph><content styleCode=\"bold\">H</content><content styleCode=\"bold\">ydatid Disease</content></paragraph></td><td styleCode=\" Toprule Lrule Rrule\"><paragraph><content styleCode=\"bold\">N</content><content styleCode=\"bold\">eurocysticercosis</content></paragraph></td></tr><tr><td colspan=\"3\" styleCode=\" Toprule Lrule Rrule\"><paragraph><content styleCode=\"bold\">G</content><content styleCode=\"bold\">astrointestinal</content></paragraph></td></tr><tr><td styleCode=\" Toprule Lrule Rrule\"><paragraph>Abdominal Pain</paragraph></td><td styleCode=\" Toprule Lrule Rrule\"><paragraph>6</paragraph></td><td styleCode=\" Toprule Lrule Rrule\"><paragraph>0</paragraph></td></tr><tr><td styleCode=\" Toprule Lrule Rrule\"><paragraph>Nausea</paragraph></td><td styleCode=\" Toprule Lrule Rrule\"><paragraph>4</paragraph></td><td styleCode=\" Toprule Lrule Rrule\"><paragraph>6</paragraph></td></tr><tr><td styleCode=\" Toprule Lrule Rrule\"><paragraph>Vomiting</paragraph></td><td styleCode=\" Toprule Lrule Rrule\"><paragraph>4</paragraph></td><td styleCode=\" Toprule Lrule Rrule\"><paragraph>6</paragraph></td></tr><tr><td colspan=\"3\" styleCode=\" Toprule Lrule Rrule\"><paragraph><content styleCode=\"bold\">G</content><content styleCode=\"bold\">eneral disorders and administration site conditions</content></paragraph></td></tr><tr><td styleCode=\" Toprule Lrule Rrule\"><paragraph>Fever</paragraph></td><td styleCode=\" Toprule Lrule Rrule\"><paragraph>1</paragraph></td><td styleCode=\" Toprule Lrule Rrule\"><paragraph>0</paragraph></td></tr><tr><td colspan=\"3\" styleCode=\" Toprule Lrule Rrule\"><paragraph><content styleCode=\"bold\">Investigations</content></paragraph></td></tr><tr><td styleCode=\" Toprule Lrule Rrule\"><paragraph>Elevated Hepatic Enzymes</paragraph></td><td styleCode=\" Toprule Lrule Rrule\"><paragraph>16</paragraph></td><td styleCode=\" Toprule Lrule Rrule\"><paragraph>less than 1</paragraph></td></tr><tr><td colspan=\"3\" styleCode=\" Toprule Lrule Rrule\"><paragraph><content styleCode=\"bold\">N</content><content styleCode=\"bold\">ervous system disorders</content></paragraph></td></tr><tr><td styleCode=\" Toprule Lrule Rrule\"><paragraph>Dizziness</paragraph></td><td styleCode=\" Toprule Lrule Rrule\"><paragraph>1</paragraph></td><td styleCode=\" Toprule Lrule Rrule\"><paragraph>less than 1</paragraph></td></tr><tr><td styleCode=\" Toprule Lrule Rrule\"><paragraph>Headache</paragraph></td><td styleCode=\" Toprule Lrule Rrule\"><paragraph>1</paragraph></td><td styleCode=\" Toprule Lrule Rrule\"><paragraph>11</paragraph></td></tr><tr><td styleCode=\" Toprule Lrule Rrule\"><paragraph>Meningeal Signs</paragraph></td><td styleCode=\" Toprule Lrule Rrule\"><paragraph>0</paragraph></td><td styleCode=\" Toprule Lrule Rrule\"><paragraph>1</paragraph></td></tr><tr><td styleCode=\" Toprule Lrule Rrule\"><paragraph>Raised Intracranial Pressure</paragraph></td><td styleCode=\" Toprule Lrule Rrule\"><paragraph>0</paragraph></td><td styleCode=\" Toprule Lrule Rrule\"><paragraph>2</paragraph></td></tr><tr><td styleCode=\" Toprule Lrule Rrule\"><paragraph>Vertigo</paragraph></td><td styleCode=\" Toprule Lrule Rrule\"><paragraph>1</paragraph></td><td styleCode=\" Toprule Lrule Rrule\"><paragraph>less than 1</paragraph></td></tr><tr><td colspan=\"3\" styleCode=\" Toprule Lrule Rrule\"><paragraph><content styleCode=\"bold\">Skin and subcutaneous tissue disorders</content></paragraph></td></tr><tr><td styleCode=\" Toprule Lrule Rrule\"><paragraph>Reversible Alopecia</paragraph></td><td styleCode=\" Toprule Lrule Rrule\"><paragraph>2</paragraph></td><td styleCode=\" Toprule Lrule Rrule\"><paragraph>less than 1</paragraph></td></tr></tbody></table>"],"information_for_patients":["17 PATIENT COUNSELING INFORMATION Patients should be advised that: Some people, particularly children, may experience difficulties swallowing the albendazole tablets whole. Take albendazole with food. Albendazole may cause fetal harm, therefore, obtain a pregnancy test in women of reproductive potential prior to initiating therapy [see Use in Specific Populations (8.1 , 8.3 )] . Advise women of reproductive potential to use effective birth control while on albendazole and for one month after completing treatment [see Use in Specific Populations (8.3) ] . During albendazole therapy, monitor blood counts and liver enzymes every 2 weeks because of the possibility of harm to the liver or bone marrow [see Warnings and Precautions (5.5) ] . TILTAB is a registered trademark of GlaxoSmithKline, used with permission. Manufactured by: GlaxoSmithKline Mississauga, Ontario L5N 6L4 Canada Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 1905-03 Rev. 09-2019-01"],"dosage_and_administration":["2 DOSAGE AND ADMINISTRATION Patients weighing 60 kg or greater, 400 mg twice daily; less than 60 kg, 15 mg/kg/day in divided doses twice daily (maximum total daily dose 800 mg). Albendazole tablets should be taken with food. ( 2 ) Hydatid disease: 28-day cycle followed by 14-day albendazole-free interval for a total of 3 cycles. ( 2 ) Neurocysticercosis: 8 to 30 days. ( 2 ) See additional important information in the Full Prescribing Information. ( 2 ) 2.1 Dosage Dosing of albendazole will vary depending upon the indication. Albendazole tablets may be crushed or chewed and swallowed with a drink of water. Albendazole tablets should be taken with food [see Clinical Pharmacology (12.3) ] . Table 1: Albendazole Dosage Indication Patient Weight Dose Duration Hydatid Disease 60 kg or greater 400 mg twice daily, with meals 28-day cycle followed by a 14-day albendazole-free interval, for a total of 3 cycles Less than 60 kg 15 mg/kg/day given in divided doses twice daily with meals (maximum total daily dose 800 mg) Neurocysticercosis 60 kg or greater 400 mg twice daily, with meals 8 to 30 days Less than 60 kg 15 mg/kg/day given in divided doses twice daily with meals (maximum total daily dose 800 mg) 2.2 Concomitant Medication to Avoid Adverse Reactions Patients being treated for neurocysticercosis should receive appropriate steroid and anticonvulsant therapy as required. Oral or intravenous corticosteroids should be considered to prevent cerebral hypertensive episodes during the first week of treatment [see Warnings and Precautions (5.3) ] . 2.3 Monitoring for Safety Before and During Treatment Monitor blood counts at the beginning of each 28-day cycle of therapy, and every 2 weeks while on therapy with albendazole in all patients [see Warnings and Precautions (5.1) ] . Monitor liver enzymes (transaminases) at the beginning of each 28-day cycle of therapy, and at least every 2 weeks during treatment with albendazole in all patients [see Warnings and Precautions (5.5) ] . Obtain a pregnancy test in women of reproductive potential prior to therapy [see Warnings and Precautions (5.2) ] ."],"spl_product_data_elements":["Albendazole albendazole ALBENDAZOLE ALBENDAZOLE CARNAUBA WAX HYPROMELLOSES LACTOSE MONOHYDRATE MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POVIDONE SODIUM LAURYL SULFATE SACCHARIN SODIUM MONOHYDRATE SODIUM STARCH GLYCOLATE TYPE A POTATO STARCH, CORN white to off-white ap;550 cirular"],"dosage_forms_and_strengths":["3 DOSAGE FORMS AND STRENGTHS Tablet: 200 mg Tablet: 200 mg ( 3 )"],"use_in_specific_populations":["8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Risk Summary There are limited data on use of albendazole in pregnant women to inform a drug-associated risk of major birth defects and miscarriage. In published studies, single-dose albendazole exposure during pregnancy did not show evidence of an increased risk of adverse maternal or fetal outcomes; however, this finding cannot be extrapolated to multiple-dose exposures ( see Data ). In animal reproductive studies, oral administration of albendazole during gestation caused embryotoxicity and skeletal malformations in pregnant rats (at oral doses of 0.10 times and 0.32 times the recommended human dose based on body surface area in mg/m 2 ) and pregnant rabbits (at oral doses of 0.60 times the recommended human dose based on body surface area in mg/m 2 ). Albendazole was also associated with maternal toxicity in rabbits (at doses of 0.60 times the recommended human dose based on body surface area in mg/m 2 ) ( see Data ). Albendazole should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Albendazole should not be used in pregnant women except in clinical circumstances where no alternative management is appropriate. If a patient becomes pregnant while taking this drug, albendazole should be discontinued immediately. If pregnancy occurs while taking this drug, the patient should be apprised of the potential hazard to the fetus. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Human Data A Cochrane review could not provide sufficient evidence of the impact of antihelminthics (including albendazole) on the pregnancy outcomes of low birthweight, perinatal mortality and preterm birth. In a large trial of about 2507 women, albendazole use during the second or third trimester of pregnancy had no overall effect on birth weight, perinatal mortality, or congenital anomalies. With a limited sample size and single-does exposure, another study could not rule out a two-fold increased risk of major malformations [4.7% vs. 2.2%; OR 2.2 (95% confidence interval (CI) 0.5 to 10.1); p = 0.26]. Animal Data Albendazole has been shown to be teratogenic (to cause embryotoxicity and skeletal malformations) in pregnant rats and rabbits. The teratogenic response in the rat was shown at oral doses of 10 and 30 mg/kg/day (0.10 times and 0.32 times the recommended human dose based on body surface area in mg/m 2 , respectively) during gestation days 6 to 15 and in pregnant rabbits at oral doses of 30 mg/kg/day (0.60 times the recommended human dose based on body surface area in mg/m 2 ) administered during gestation days 7 to 19. In the rabbit study, maternal toxicity (33% mortality) was noted at 30 mg/kg/day. In mice, no teratogenic effects were observed at oral doses up to 30 mg/kg/day (0.16 times the recommended human dose based on body surface area in mg/m 2 ), administered during gestation days 6 to 15. 8.2 Lactation Risk Summary There are no data on the presence of albendazole in human milk, the effects on the breast-fed infant or the effects on milk production. Albendazole is excreted in animal milk. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for albendazole and any potential adverse effects on the breastfed child from albendazole or from the underlying maternal condition. 8.3 Females and Males of Reproductive Potential Pregnancy Testing Obtain pregnancy test prior to prescribing albendazole to women of reproductive potential. Contraception Females Advise women of reproductive potential to use effective birth control for the duration of albendazole therapy and for one month after end of therapy. 8.4 Pediatric Use Hydatid disease is uncommon in infants and young children. In neurocysticercosis, the efficacy of albendazole in children appears to be similar to that in adults. 8.5 Geriatric Use In patients aged 65 and older with either hydatid disease or neurocysticercosis, there was insufficient data to determine whether the safety and effectiveness of albendazole is different from that of younger patients. 8.6 Patients with Impaired Renal Function The pharmacokinetics of albendazole in patients with impaired renal function has not been studied. 8.7 Patients with Extra-Hepatic Obstruction In patients with evidence of extrahepatic obstruction (n = 5), the systemic availability of albendazole sulfoxide was increased, as indicated by a 2-fold increase in maximum serum concentration and a 7-fold increase in area under the curve. The rate of absorption/conversion and elimination of albendazole sulfoxide appeared to be prolonged with mean T max and serum elimination half-life values of 10 hours and 31.7 hours, respectively. Plasma concentrations of parent albendazole were measurable in only 1 of 5 patients."],"dosage_and_administration_table":["<table width=\"100%\" cellspacing=\"0\" cellpadding=\"0\" border=\"1\"><col width=\"17pt\"/><col width=\"17pt\"/><col width=\"17pt\"/><col width=\"17pt\"/><thead><tr><th styleCode=\" Botrule Toprule Lrule Rrule\">Indication</th><th styleCode=\" Botrule Toprule Lrule Rrule\">Patient Weight</th><th styleCode=\" Botrule Toprule Lrule Rrule\">Dose</th><th styleCode=\" Botrule Toprule Lrule Rrule\">Duration</th></tr></thead><tbody><tr><td rowspan=\"2\" styleCode=\" Botrule Toprule Lrule Rrule\"><paragraph>Hydatid Disease</paragraph></td><td styleCode=\" Botrule Toprule Lrule Rrule\"><paragraph>60 kg or greater</paragraph></td><td styleCode=\" Botrule Toprule Lrule Rrule\"><paragraph>400 mg twice daily, with meals</paragraph></td><td rowspan=\"2\" styleCode=\" Botrule Toprule Lrule Rrule\"><paragraph>28-day cycle followed by a 14-day albendazole-free interval, for a total of 3 cycles</paragraph></td></tr><tr><td styleCode=\" Botrule Toprule Lrule Rrule\"><paragraph>Less than 60 kg</paragraph></td><td styleCode=\" Botrule Toprule Lrule Rrule\"><paragraph>15 mg/kg/day given in divided doses twice daily with meals (maximum total daily dose 800 mg)</paragraph></td></tr><tr><td rowspan=\"2\" styleCode=\" Botrule Toprule Lrule Rrule\"><paragraph>Neurocysticercosis</paragraph></td><td styleCode=\" Botrule Toprule Lrule Rrule\"><paragraph>60 kg or greater</paragraph></td><td styleCode=\" Botrule Toprule Lrule Rrule\"><paragraph>400 mg twice daily, with meals</paragraph></td><td rowspan=\"2\" styleCode=\" Botrule Toprule Lrule Rrule\"><paragraph>8 to 30 days</paragraph></td></tr><tr><td styleCode=\" Botrule Toprule Lrule Rrule\"><paragraph>Less than 60 kg</paragraph></td><td styleCode=\" Botrule Toprule Lrule Rrule\"><paragraph>15 mg/kg/day given in divided doses twice daily with meals (maximum total daily dose 800 mg)</paragraph></td></tr></tbody></table>"],"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL 1"],"carcinogenesis_and_mutagenesis_and_impairment_of_fertility":["13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term carcinogenicity studies were conducted in mice and rats. No evidence of increased incidence of tumors was found in the mice or rats at up to 400 mg/kg/day or 20 mg/kg/day respectively (2 times and 0.2 times the recommended human dose on a body surface area basis). In genotoxicity tests, albendazole was found negative in an Ames Salmonella/Microsome Plate mutation assay, Chinese Hamster Ovary chromosomal aberration test, and in vivo mouse micronucleus test. In the in vitro BALB/3T3 cells transformation assay, albendazole produced weak activity in the presence of metabolic activation while no activity was found in the absence of metabolic activation. Albendazole did not adversely affect male or female fertility in the rat at an oral dose of 30 mg/kg/day (0.32 times the recommended human dose based on body surface area in mg/m 2 )."]},"tags":[{"label":"Anthelmintic","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"P02CA03","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":"Cerebral cysticercosis","category":"indication"},{"label":"Echinococcus Granulosus Infection of the Peritoneum","category":"indication"},{"label":"Echinococcus granulosus infection","category":"indication"},{"label":"Echinococcus granulosus infection of liver","category":"indication"},{"label":"Echinococcus granulosus infection of lung","category":"indication"},{"label":"Impax Labs Inc","category":"company"},{"label":"Approved 1990s","category":"decade"},{"label":"Anthelmintics","category":"pharmacology"},{"label":"Anti-Infective Agents","category":"pharmacology"},{"label":"Anticestodal Agents","category":"pharmacology"},{"label":"Antimitotic Agents","category":"pharmacology"},{"label":"Antiparasitic Agents","category":"pharmacology"},{"label":"Antiplatyhelmintic Agents","category":"pharmacology"},{"label":"Antiprotozoal Agents","category":"pharmacology"},{"label":"Tubulin Modulators","category":"pharmacology"}],"phase":"marketed","safety":{"boxedWarnings":[],"safetySignals":[{"date":"","signal":"DRUG INEFFECTIVE","source":"FDA FAERS","actionTaken":"365 reports"},{"date":"","signal":"OFF LABEL USE","source":"FDA FAERS","actionTaken":"284 reports"},{"date":"","signal":"PYREXIA","source":"FDA FAERS","actionTaken":"236 reports"},{"date":"","signal":"PRODUCT USE IN UNAPPROVED INDICATION","source":"FDA FAERS","actionTaken":"224 reports"},{"date":"","signal":"HEADACHE","source":"FDA FAERS","actionTaken":"221 reports"},{"date":"","signal":"CONDITION AGGRAVATED","source":"FDA FAERS","actionTaken":"212 reports"},{"date":"","signal":"FATIGUE","source":"FDA FAERS","actionTaken":"166 reports"},{"date":"","signal":"WEIGHT DECREASED","source":"FDA FAERS","actionTaken":"166 reports"},{"date":"","signal":"RASH","source":"FDA FAERS","actionTaken":"165 reports"},{"date":"","signal":"PAIN","source":"FDA FAERS","actionTaken":"164 reports"}],"drugInteractions":[{"drug":"Dexamethasone","severity":"moderate","mechanism":"Coadministration increases steady-state trough concentrations of albendazole sulfoxide.","management":"Monitor albendazole levels if coadministered.","clinicalEffect":"Steady-state trough concentrations of albendazole sulfoxide were about 56% higher."},{"drug":"Praziquantel","severity":"moderate","mechanism":"In the fed state, praziquantel increases mean maximum plasma concentration and area under the curve of albendazole sulfoxide.","management":"Monitor albendazole levels if coadministered.","clinicalEffect":"Increased mean maximum plasma concentration and area under the curve of albendazole sulfoxide by about 50%."},{"drug":"Cimetidine","severity":"moderate","mechanism":"Cimetidine increases albendazole sulfoxide concentrations in bile and cystic fluid.","management":"Monitor albendazole levels if coadministered.","clinicalEffect":"Albendazole sulfoxide concentrations in bile and cystic fluid were increased by about 2-fold."},{"drug":"Theophylline","severity":"minor","mechanism":"Albendazole induces cytochrome P450 1A, which may affect theophylline metabolism.","management":"Monitor theophylline plasma concentrations during and after treatment.","clinicalEffect":"Pharmacokinetics of theophylline were unchanged following a single dose of albendazole."}],"commonSideEffects":[{"effect":"abnormal liver function tests","drugRate":"16%","_validated":true,"placeboRate":""},{"effect":"abdominal pain","drugRate":"6%","_validated":true,"placeboRate":""},{"effect":"nausea","drugRate":"4%","_validated":true,"placeboRate":""},{"effect":"vomiting","drugRate":"4%","_validated":true,"placeboRate":""},{"effect":"reversible alopecia","drugRate":"2%","_validated":true,"placeboRate":""},{"effect":"fever","drugRate":"1%","_validated":true,"placeboRate":""},{"effect":"dizziness","drugRate":"1%","_validated":true,"placeboRate":""},{"effect":"headache","drugRate":"1%","_validated":true,"placeboRate":""},{"effect":"vertigo","drugRate":"1%","_validated":true,"placeboRate":""},{"effect":"headache","drugRate":"11%","_validated":true,"placeboRate":""},{"effect":"raised intracranial pressure","drugRate":"2%","_validated":true,"placeboRate":""},{"effect":"meningeal signs","drugRate":"1%","_validated":true,"placeboRate":""}],"contraindications":["Albendazole is contraindicated in patients with known hypersensitivity to the benzimidazole class of compounds.","Albendazole is contraindicated in patients with known hypersensitivity to any components of albendazole."],"specialPopulations":{"Lactation":"Concentrations of albendazole and the active metabolite, albendazole sulfoxide, have been reported to be low in human breast milk. There are no reports of adverse effects on the breastfed infant and no information on the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mothers clinical need for albendazole and any potential adverse effects on the breastfed infant from albendazole or from the underlying disease.","Pregnancy":"Albendazole should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Albendazole should not be used in pregnant women except in clinical circumstances where no alternative management is appropriate. If patient becomes pregnant while taking this drug, albendazole should be discontinued immediately. If pregnancy occurs while taking this drug, the patient should be apprised of the potential hazard to the fetus.","Geriatric use":"In patients aged 65 and older with either hydatid disease or neurocysticercosis, there was insufficient data to determine whether the safety and effectiveness of albendazole is different from that of younger patients.","Paediatric use":"Hydatid disease is uncommon in infants and young children. In neurocysticercosis, the efficacy of albendazole in children appears to be similar to that in adults."},"discontinuationRates":[{"trial":"hydatid disease","drugArm":"0.7%","placeboArm":"","commonReason":"leukopenia"},{"trial":"hydatid disease","drugArm":"3.8%","placeboArm":"","commonReason":"hepatic abnormalities"}],"seriousAdverseEvents":[{"event":"leukopenia","detail":"leading cause of treatment discontinuation","severity":"serious","incidence":"0.7%"},{"event":"hepatic abnormalities","detail":"leading cause of treatment discontinuation in hydatid disease","severity":"serious","incidence":"3.8%"}]},"trials":[],"aliases":[],"company":"Impax Labs Inc","patents":[],"pricing":[{"market":"United States","source":"CMS National Average Drug Acquisition Cost (NADAC)","asOfDate":"2024-01-03","unitCost":"$10.9032/EA","priceType":"NADAC","sourceUrl":"https://data.medicaid.gov/dataset/4j6z-xnwq","annualCost":"$3,980","description":"ALBENDAZOLE 200 MG TABLET","retrievedDate":"2026-04-07"}],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=ALBENDAZOLE","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T00:37:07.933770+00:00"},"timeline":{"url":"https://en.wikipedia.org/wiki/Albendazole","method":"deterministic","source":"Wikipedia","rawText":"","confidence":0.8,"sourceType":"wikipedia","retrievedAt":"2026-04-20T00:37:15.875957+00:00"},"aiSummary":{"url":"","method":"ai_extraction","source":"AI Strategic Summary","aiModel":"featherless","rawText":"","confidence":0.9,"sourceType":"ai_extraction","retrievedAt":"2026-04-20T00:38:37.270745+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T00:37:14.341983+00:00"},"regulatory.us":{"url":"","method":"api_direct","source":"FDA Drugs@FDA","rawText":"","confidence":1,"sourceType":"fda_drugsfda","retrievedAt":"2026-04-20T00:37:06.561059+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=ALBENDAZOLE","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T00:37:15.169793+00:00"},"mechanism.drugClass":{"url":"https://api.fda.gov/drug/label.json","method":"deterministic","source":"FDA Label (EPC)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T00:37:05.390085+00:00"},"administration.route":{"url":"","method":"deterministic","source":"FDA Label","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T00:37:05.390131+00:00"},"indications.approved":{"url":"","method":"ai_extraction","source":"FDA Label + AI","aiModel":"featherless","rawText":"","confidence":0.9,"sourceType":"fda_label","retrievedAt":"2026-04-20T00:38:26.961867+00:00"},"safety.boxedWarnings":{"url":"","method":"deterministic","source":"FDA Label (no boxed warning)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T00:37:05.390140+00:00"},"safety.safetySignals":{"url":"https://api.fda.gov/drug/event.json","method":"api_direct","source":"FDA FAERS","rawText":"","confidence":1,"sourceType":"fda_faers","retrievedAt":"2026-04-20T00:37:16.780259+00:00"},"mechanism.target_chembl":{"url":"","method":"api_direct","source":"ChEMBL mechanism: Tubulin inhibitor","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T00:37:15.874313+00:00"},"safety.drugInteractions":{"url":"","method":"ai_extraction","source":"FDA Label + AI","aiModel":"featherless","rawText":"","confidence":0.9,"sourceType":"fda_label","retrievedAt":"2026-04-20T00:38:15.776682+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL1483/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T00:37:15.773655+00:00"},"safety.commonSideEffects":{"url":"","method":"ai_extraction","source":"FDA Label + AI","aiModel":"featherless","rawText":"6 ADVERSE REACTIONS Adverse reactions 1% or greater in hydatid disease: abnormal liver function tests, abdominal pain, nausea/vomiting, reversible alopecia, headache, dizziness/vertigo, fever. ( 6.1 ) Adverse reactions 1% or greater in neurocysticercosis: headache, nausea/vomiting, raised intracranial pressure, meningeal signs. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Amneal Pharmaceuticals at 1-877-835-5472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Expe","confidence":0.95,"sourceType":"fda_label","retrievedAt":"2026-04-20T00:37:47.185369+00:00"},"safety.contraindications":{"url":"","method":"ai_extraction","source":"FDA Label + AI","aiModel":"featherless","rawText":"","confidence":0.95,"sourceType":"fda_label","retrievedAt":"2026-04-20T00:37:52.085576+00:00"},"regulatory.fda_application":{"url":"","method":"deterministic","source":"FDA Label","rawText":"NDA020666","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T00:37:05.390145+00:00"}},"allNames":"albenza","offLabel":[],"synonyms":["albendazole","albamelin","albendol","albenza"],"timeline":[{"date":"1996-01-01","type":"neutral","source":"FDA Orange Book","milestone":"Rights transferred from AMEDRA PHARMS to Impax Labs Inc"},{"date":"1996-06-11","type":"positive","source":"DrugCentral","milestone":"FDA approval (Amedra Pharms)"},{"date":"2018-12-14","type":"neutral","source":"FDA Orange Book","milestone":"Generic entry — 3 manufacturers approved"}],"aiSummary":"Albendazole (Albenza), marketed by Impax Labs Inc, is a leading treatment for parenchymal neurocysticercosis with a key composition patent expiring in 2028. Its mechanism of action, which disrupts the function of the parasite's microtubules, provides a strong therapeutic profile against targeted parasitic infections. The primary risk is competition from off-patent generics such as mebendazole, which has been available since 1974, and other same-class drugs like thiabendazole and fenbendazole.","brandName":"Albenza","ecosystem":[{"indication":"Cerebral cysticercosis","otherDrugs":[],"globalPrevalence":null},{"indication":"Echinococcus Granulosus Infection of the Peritoneum","otherDrugs":[],"globalPrevalence":null},{"indication":"Echinococcus granulosus infection","otherDrugs":[],"globalPrevalence":null},{"indication":"Echinococcus granulosus infection of liver","otherDrugs":[],"globalPrevalence":null},{"indication":"Echinococcus granulosus infection of lung","otherDrugs":[],"globalPrevalence":null}],"mechanism":{"novelty":"Follow-on","moaClass":"Cytochrome P450 1A Inducers","modality":"Small Molecule","drugClass":"Anthelmintic [EPC]","explanation":"Albendazole is synthetic, antihelminthic drug of the class benzimidazole [see Clinical Pharmacology (12.4)].","oneSentence":"Albenza works by binding to tubulin in the parasite's microtubules, disrupting their function and ultimately leading to the parasite's death.","technicalDetail":"Albendazole binds to tubulin, a protein component of microtubules, preventing polymerization and thereby disrupting the microtubule dynamics, which is essential for the parasite's survival and reproduction."},"_wikipedia":{"url":"https://en.wikipedia.org/wiki/Albendazole","title":"Albendazole","extract":"Albendazole is a broad-spectrum antihelmintic and antiprotozoal agent of the benzimidazole type. It is used for the treatment of a variety of intestinal parasite infections, including ascariasis, pinworm infection, hookworm infection, trichuriasis, strongyloidiasis, taeniasis, clonorchiasis, opisthorchiasis, cutaneous larva migrans, giardiasis, and gnathostomiasis, among other diseases.","wiki_history":"==History==\nAlbendazole, patented in 1975, was invented by Robert J. Gyurik and Vassilios J. Theodorides and assigned to SmithKline Corporation. It was introduced in 1977 as an antihelminthic for sheep in Australia, and was registered for human use in 1982.","wiki_society_and_culture":"==Society and culture==\nthumb|Discarded bottles of albendazole distributed in Africa\n\n===Economics===\nThe pharmaceutical company Amedra increased the price after purchasing the rights to the drug, instead of lowering it as generics are predicted to do, drawing criticism from patients' rights advocates.\n\nIn 2013, GlaxoSmithKline donated 763 million albendazole tablets for the treatment and prevention of parasitic infections in developing countries, bringing the total to over 4 billion tablets donated since 1998.\n\n===Brand names===\nBrand names include: Albenza, Alworm, Andazol, Eskazole, Noworm, Zentel, Alben-G, ABZ, Cidazole, Wormnil etc."},"commercial":{"launchDate":"1996","_launchSource":"DrugCentral (FDA 1996-06-11, AMEDRA PHARMS)"},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/103","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=ALBENDAZOLE","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=ALBENDAZOLE","fields":["publications"],"source":"PubMed/NCBI"},{"id":4,"url":"https://en.wikipedia.org/wiki/Albendazole","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":"2026-03-30T08:33:23.475375","_validation":{"fieldsValidated":3,"lastValidatedAt":"2026-04-20T00:38:37.271217+00:00","fieldsConflicting":0,"overallConfidence":0.95},"biosimilars":[],"competitors":[{"drugName":"mebendazole","drugSlug":"mebendazole","fdaApproval":"1974-06-28","genericCount":1,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"thiabendazole","drugSlug":"thiabendazole","fdaApproval":"1967-04-07","patentStatus":"Unknown","relationship":"same-class"},{"drugName":"fenbendazole","drugSlug":"fenbendazole","fdaApproval":"","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":"albendazole","indications":{"approved":[{"id":"albendazole-parenchymal-neurocysticercosis","name":"Parenchymal 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