{"id":"ferric-citrate","rwe":[{"pmid":"41897502","year":"2026","title":"Dimercaprol Reprograms Intestinal Redox Homeostasis and Organelle Crosstalk to Combat Iron-Induced Gut Dysbiosis Through NRF2/HO-1 Signaling.","finding":"","journal":"Antioxidants (Basel, Switzerland)","studyType":"Clinical Study"},{"pmid":"41882749","year":"2026","title":"Safety of Ferric Citrate Hydrate in Pregnant Women With Iron Deficiency Anemia, Fetuses, and Newborns: A Real-World, Observational, Post-Marketing Surveillance Study.","finding":"","journal":"The journal of obstetrics and gynaecology research","studyType":"Clinical Study"},{"pmid":"41818967","year":"2026","title":"Unveiling the synergistic regulation of Co-metabolic substrates and Fe(III) on tetrabromobisphenol A degradation by Geobacter sulfurreducens PCA.","finding":"","journal":"Journal of environmental management","studyType":"Clinical Study"},{"pmid":"41815919","year":"2026","title":"Safe dosage and potential risks of chlorogenic acid: insights from in vitro and in vivo studies.","finding":"","journal":"Frontiers in pharmacology","studyType":"Clinical Study"},{"pmid":"41703145","year":"2026","title":"A robust aminothiazole-based colorimetric sensor for visual detection of Fe(3+) ions in environmental and pharmaceutical samples.","finding":"","journal":"Scientific reports","studyType":"Clinical Study"}],"_fda":{"id":"b21d112b-5910-49b0-bba4-2e4339fcc89c","set_id":"314bd2e4-2ca5-4e2a-9fea-13373f910f34","openfda":{"upc":["0044200004901"],"unii":["63G354M39Z"],"route":["ORAL"],"rxcui":["1594680"],"spl_id":["b21d112b-5910-49b0-bba4-2e4339fcc89c"],"brand_name":["Ferric Citrate"],"spl_set_id":["314bd2e4-2ca5-4e2a-9fea-13373f910f34"],"package_ndc":["0480-2996-97"],"product_ndc":["0480-2996"],"generic_name":["FERRIC CITRATE"],"product_type":["HUMAN PRESCRIPTION DRUG"],"substance_name":["FERRIC CITRATE"],"manufacturer_name":["Teva Pharmaceuticals, Inc."],"application_number":["ANDA212563"],"is_original_packager":[true]},"version":"1","pregnancy":["8.1 Pregnancy Risk Summary There are no available data on ferric citrate use in pregnant women to inform a drug-associated risk of major birth defects and miscarriage. Animal reproduction studies have not been conducted using ferric citrate. Skeletal and encephalic malformation was observed in neonatal mice when ferric gluconate was administered intraperitoneally to gravid dams on gestation days 7 to 9. However, oral administration of other ferric or ferrous compounds to gravid CD1-mice and Wistar-rats caused no fetal malformation. An overdose of iron in pregnant women may carry a risk for spontaneous abortion, gestational diabetes and fetal malformation. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. Adverse outcomes in pregnancy occur regardless of the health of the mother or the use of medications. In the U.S. general population, the estimated background risks of major birth defects and miscarriage in clinically recognized pregnancies are 2% to 4% and 15% to 20%, respectively. Clinical Considerations The effect of ferric citrate on the absorption of vitamins and other nutrients has not been studied in pregnant women. Requirements for vitamins and other nutrients are increased in pregnancy."],"overdosage":["10 OVERDOSAGE No data are available regarding overdose of ferric citrate in patients. In patients with chronic kidney disease, the maximum dose studied was 2,520 mg ferric iron (12 tablets of ferric citrate) per day. Iron absorption from ferric citrate may lead to excessive elevations in iron stores, especially when concomitant intravenous iron is used [see Warnings and Precautions (5.1)] . In clinical trials, one case of elevated iron in the liver as confirmed by biopsy was reported in a patient on dialysis administered intravenous iron and ferric citrate."],"description":["11 DESCRIPTION Ferric citrate, a phosphate binder and iron replacement product, is known chemically as iron (+3), x (1, 2, 3-propanetricarboxylic acid, 2-hydroxy-), y (H 2 O) The structural formula is below: Ferric citrate tablets for oral administration are pink, oval shaped, film-coated tablets containing 210 mg of ferric iron which is equivalent to 1 g of ferric citrate. In addition, each tablet contains the following inactive ingredients: calcium stearate, FD&C Blue #2/Indigo Carmine Aluminum Lake, FD&C Red #40/Allura Red AC Aluminum Lake, FD&C Yellow #6/Sunset Yellow FCF Aluminum Lake, hypromellose 2910, polyethylene glycol 4000, pregelatinized corn starch, and titanium dioxide. 1"],"how_supplied":["16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied Ferric Citrate tablets are available as follows: 210 mg – Each pink, film-coated, oval tablet debossed with “W824” on one side and “TEVA” on the other side contains 210 mg ferric iron equivalent to 1 g ferric citrate. Tablets are supplied in bottles of 200 (NDC 0480-2996-97). 16.2 Storage and Handling Storage: Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from moisture."],"geriatric_use":["8.5 Geriatric Use Clinical studies of ferric citrate included 292 subjects aged 65 years and older (104 subjects aged 75 years and older). Overall, the clinical study experience has not identified any obvious differences in responses between the elderly and younger patients in the tolerability or efficacy of ferric citrate."],"pediatric_use":["8.4 Pediatric Use The safety and efficacy of ferric citrate has not been established in pediatric patients. Juvenile Animal Toxicity Data In animal studies, greater gastrointestinal toxicity was observed when ferric citrate was administered by gavage as compared to administration with solid food. Because ferric citrate is recommended to be taken with meals and patients under 6 months of age are unlikely to be eating solid food, they may be at greater risk of gastrointestinal toxicity."],"effective_time":"20241101","clinical_studies":["14 CLINICAL STUDIES 14.1 Hyperphosphatemia in Chronic Kidney Disease on Dialysis The ability of ferric citrate to lower serum phosphorus in patients with CKD on dialysis was demonstrated in randomized clinical trials: one 56-week, safety and efficacy trial, consisting of a 52-week active-controlled phase and a 4-week, placebo-controlled, randomized withdrawal period, and one 4-week open-label trial of different fixed doses of ferric citrate. Both trials excluded subjects who had an absolute requirement for aluminum containing drugs with meals. Study KRX-0502-304 (NCT 01191255) Study KRX-0502-304 was a long-term, randomized, controlled, safety and efficacy trial. After the 2-week washout period during which phosphate binders were held, patients with a mean serum phosphorus of 7.5 mg/dL during washout were randomized 2:1 to ferric citrate (N=292) or active control (calcium acetate and/or sevelamer carbonate; N=149). The majority (>96%) of subjects were on hemodialysis. The starting dose of ferric citrate was 6 tablets/day, divided with meals. The starting dose of active control was the patient’s dose prior to the washout period. The dose of phosphate binder was increased or decreased as needed to maintain serum phosphorus levels between 3.5 and 5.5 mg/dL, to a maximum of 12 tablets/day. As shown in the figure below, serum phosphorus levels declined following initiation of therapy. The phosphorus lowering effect was maintained over 52 weeks of treatment. Figure 1: Serum Phosphorus Control over 52 Weeks Following completion of the 52-week active-controlled phase, ferric citrate-treated patients were eligible to enter a 4-week placebo-controlled randomized withdrawal phase, in which patients were re-randomized in a 1:1 ratio to receive ferric citrate (N=96) or placebo (N=96). During the placebo-controlled period, the serum phosphorus concentration rose by 2.2 mg/dL on placebo relative to patients who remained on ferric citrate. Table 3: Effect of Ferric Citrate on serum phosphorus during randomized withdrawal Primary Endpoint (Week 56) Ferric Citrate Placebo Treatment Difference (95% CI) p-value Serum phosphorus (mg/dL) Mean baseline (Week 52) Mean change from baseline (Week 56) 5.12 −0.24 5.44 1.79 −2.18 (−2.59, −1.77) <0.0001 a a The LS mean treatment difference and p-value for the change in mean were created via an ANCOVA model with treatment as the fixed effect and Week-52 baseline (phosphorus) as the covariate. Between-treatment differences were calculated as the LS mean (ferric citrate) – LS mean (placebo or active control). Note: Analyses using ANCOVA with last observation carried forward. ANCOVA=analysis of covariance; CI=confidence interval. Study KRX-0502-305 (NCT 01074125) Following a 1- to 2-week washout from all phosphate-binding agents, 154 patients with hyperphosphatemia (mean serum phosphorus of 7.5 mg/dL) and CKD on dialysis were randomized in a 1:1:1 ratio to 1, 6, or 8 tablets/day of ferric citrate for 4 weeks. Ferric citrate was administered with meals; subjects receiving 1 tablet/day were instructed to take it with their largest meal of the day, and subjects on 6 or 8 tablets/day took divided doses in any distribution with meals. Dose-dependent decreases in serum phosphorus were observed by Day 7 and remained relatively stable for the duration of treatment. The demonstrated reductions from baseline to Week 4 in mean serum phosphorus were significantly greater with 6 and 8 tablets/day than with 1 tablet/day (p<0.0001). Mean reduction in serum phosphorus at Week 4 was 0.1 mg/dL with 1 tablet/day, 1.9 mg/dL with 6 tablets/day, and 2.1 mg/dL with 8 tablets/day. 1 14.2 Iron Deficiency Anemia in Chronic Kidney Disease Not on Dialysis Study KRX-0502-306 (NCT 02268994) The efficacy of ferric citrate for the treatment of iron deficiency anemia in adult patients with CKD not on dialysis was demonstrated in a 24-week study consisting of a 16-week, randomized, double-blind, placebo-controlled, efficacy period followed by an 8-week open-label safety extension period in which all patients remaining in the study, including the placebo group, received ferric citrate. Patients with eGFR <60 mL/min/1.73m 2 , who were intolerant of or have had an inadequate therapeutic response to oral iron supplements, with Hgb ≥9.0 g/dL and ≤11.5 g/dL, serum ferritin ≤200 ng/mL and TSAT ≤25% were enrolled. Patients were randomized to treatment with either ferric citrate (n=117) or placebo (n= 117). Dosing with ferric citrate or placebo was initiated at 3 tablets/day with meals. Dose titration could occur at Weeks 4, 8 and 12 during Randomized Period, and at Weeks 18 and 20 during Safety Extension Period based on Hgb response. Use of oral or intravenous iron, erythropoiesis stimulating agents (ESAs) was not permitted at any time during the study. The mean age of the patients was 65 years (range 26 to 93); 63% were female, 69% Caucasian, 30% were African American and <2% were other races. The main efficacy outcome measure was the proportion of subjects achieving an increase in Hgb of ≥1.0 g/dL at any time point between baseline and the end of the 16-week Randomized Period. Table 4: Efficacy of Ferric Citrate in Iron Deficiency Anemia in Chronic Kidney Disease (Not on Dialysis) Ferric Citrate (N=117) Placebo (N=115) p-value Proportion of patients achieving an increase in hemoglobin of ≥1.0 g/dL at any time point during the 16 week randomized period 52% 19% <0.001 During the 16-week randomized period 49% of subjects in the ferric citrate arm and 15% of subjects in the placebo arm (p <0.001) had a mean change in hemoglobin from baseline ≥0.75 g/dL over any 4-week time period provided that an increase of at least 1.0 g/dL had occurred during that 4-week period. Increases in mean hemoglobin (0.75 ± 0.09 g/dL), serum ferritin (163 ± 9 ng/mL) and transferrin saturation (18 ± 1%) were observed from baseline during the 16-week randomized period in the ferric citrate arm."],"pharmacodynamics":["12.2 Pharmacodynamics Hyperphosphatemia in Chronic Kidney Disease on Dialysis Ferric citrate reduces serum phosphorus levels and has also been shown to increase serum iron parameters, including ferritin, iron and TSAT. In dialysis patients treated with ferric citrate for hyperphosphatemia in a 52-week study in which intravenous iron could also be administered, mean (SD) ferritin levels rose from 593 (293) ng/mL to 895 (482) ng/mL, mean (SD) TSAT levels rose from 31% (11) to 39% (17) and mean (SD) iron levels rose from 73 (29) mcg/dL to 88 (42) mcg/dL. In contrast, in patients treated with active control, these parameters remained relatively constant [see Contraindications (4) and Warnings and Precautions (5.1)] . Iron Deficiency Anemia in Chronic Kidney Disease Not on Dialysis Ferric citrate may increase hemoglobin levels and has also been shown to reduce serum phosphorus levels. In chronic kidney disease patients not on dialysis treated with ferric citrate for iron deficiency anemia in a 16-week placebo-controlled study, mean (SD) phosphorus levels decreased from 4.23 (0.91) mg/dL at baseline to 3.72 (0.60) mg/dL. In comparison, in patients treated with placebo control, mean (SD) phosphorus levels decreased from 4.12 (0.68) mg/dL at baseline to 3.87 (0.68) mg/dL."],"pharmacokinetics":["12.3 Pharmacokinetics Absorption and Distribution Formal pharmacokinetic studies have not been performed with ferric citrate. Examination of serum iron parameters has shown that there is systemic absorption of iron from ferric citrate [see Contraindications (4), Warnings and Precautions (5.1) and Clinical Pharmacology (12.1)] . Drug Interaction Studies In vitro Of the drugs screened for an interaction with ferric citrate in vitro, only doxycycline showed the potential for interaction with at least 70% decrease in its concentration. This interaction can be avoided by spacing the administration of doxycycline and ferric citrate [see Drug Interactions (7)] . In vivo Six drug interaction studies (N=26 to 60/study) were conducted to establish the effects of ferric citrate (administered as 3 x 2 g/day with meals) on the disposition of concomitantly orally administered clopidogrel, ciprofloxacin, digoxin, diltiazem, glimepiride and losartan in healthy subjects. With the exception of ciprofloxacin, ferric citrate did not alter the systemic exposure of the tested drugs, as measured by the area under the curve (AUC) and C max of the tested drugs when either co-administered with ferric citrate or given 2 hours later. Ferric citrate decreased the relative bioavailability of concomitantly administered ciprofloxacin by approximately 45%. However, there was no interaction when ferric citrate and ciprofloxacin were taken 2 hours apart. Consequently, ciprofloxacin should be taken at least 2 hours before or after ferric citrate is dosed [see Drug Interactions (7)] ."],"adverse_reactions":["6 ADVERSE REACTIONS Most common adverse reactions (incidence ≥5%) are discolored feces, diarrhea, constipation, nausea, vomiting, cough, abdominal pain, and hyperkalemia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Teva at 1-888-838-2872 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 adverse reaction rates in the clinical trials of another drug and may not reflect the rates observed in practice. Hyperphosphatemia in Chronic Kidney Disease on Dialysis A total of 289 patients were treated with ferric citrate and 149 patients were treated with active control (sevelamer carbonate and/or calcium acetate) during the 52-week, randomized, open-label, active control phase of a trial in patients on dialysis. A total of 322 patients were treated with ferric citrate for up to 28 days in three short-term trials. Across these trials, 557 unique patients were treated with ferric citrate; dosage regimens in these trials ranged from 210 mg to 2,520 mg of ferric iron per day, equivalent to 1 to 12 tablets of ferric citrate. Adverse reactions reported in more than 5% of patients treated with ferric citrate in these trials included diarrhea (21%), discolored feces (19%), nausea (11%), constipation (8%), vomiting (7%), and cough (6%). During the 52-week, active-control period, 61 patients (21%) on ferric citrate discontinued study drug because of an adverse reaction, as compared to 21 patients (14%) in the active control arm. Patients who were previously intolerant to any of the active control treatments (calcium acetate and sevelamer carbonate) were not eligible to enroll in the study. Gastrointestinal adverse reactions were the most common reason for discontinuing ferric citrate (14%). Iron Deficiency Anemia in Chronic Kidney Disease Not on Dialysis Across two trials, 190 patients with CKD-NDD were treated with ferric citrate. This included a study of 117 patients treated with ferric citrate and 116 patients treated with placebo in a 16-week, randomized, double-blind period and a study of 75 patients treated with ferric citrate and 73 treated with placebo in a 12-week randomized double-blind period. Dosage regimens in these trials ranged from 210 mg to 2,520 mg of ferric iron per day, equivalent to 1 to 12 tablets of ferric citrate. Adverse reactions reported in at least 5% of patients treated with ferric citrate in these trials are listed in Table 1. Table 1: Adverse Reactions Reported in Two Clinical Trials in at least 5% of patients receiving Ferric Citrate Body System Adverse Reaction Ferric Citrate % (N=190) Placebo % (N=188) Any Adverse Reaction 75 62 Metabolism and Nutrition Disorders Hyperkalemia 5 3 Gastrointestinal Disorders Discolored Feces 22 0 Diarrhea 21 12 Constipation 18 10 Nausea 10 4 Abdominal Pain 5 2 During the 16-week, placebo-control trial, 12 patients (10%) on ferric citrate discontinued study drug because of an adverse reaction, as compared to 10 patients (9%) in the placebo control arm. Diarrhea was the most common adverse reaction leading to discontinuation of ferric citrate (2.6%)."],"contraindications":["4 CONTRAINDICATIONS Ferric citrate is contraindicated in patients with iron overload syndromes (e.g., hemochromatosis) [see Warnings and Precautions (5.1)] . Iron overload syndromes (e.g., hemochromatosis). ( 4 )"],"drug_interactions":["7 DRUG INTERACTIONS Table 2: Oral drugs that can be administered concomitantly with ferric citrate Amlodipine Aspirin Atorvastatin Calcitriol Clopidogrel Digoxin Diltiazem Doxercalciferol Enalapril Fluvastatin Glimepiride Levofloxacin Losartan Metoprolol Pravastatin Propranolol Sitagliptin Warfarin Oral drugs that have to be separated from ferric citrate and meals Dosing Recommendations Doxycycline Take at least 1 hour before ferric citrate Ciprofloxacin Take at least 2 hours before or after ferric citrate Oral medications not listed in Table 2. There are no empirical data on avoiding drug interactions between ferric citrate and most concomitant oral drugs. For oral medications where a reduction in the bioavailability of that medication would have a clinically significant effect on its safety or efficacy, consider separation of the timing of the administration of the two drugs. The duration of separation depends upon the absorption characteristics of the medication concomitantly administered, such as the time to reach peak systemic levels and whether the drug is an immediate release or an extended release product. Consider monitoring clinical responses or blood levels of concomitant medications that have a narrow therapeutic range. When clinically significant drug interactions are expected, consider separation of the timing of administration. Consider monitoring clinical responses or blood levels of the concomitant medication. ( 7 )"],"mechanism_of_action":["12.1 Mechanism of Action Hyperphosphatemia in Chronic Kidney Disease on Dialysis Ferric iron binds dietary phosphate in the GI tract and precipitates as ferric phosphate. This compound is insoluble and is excreted in the stool. By binding phosphate in the GI tract and decreasing absorption, ferric citrate lowers the phosphate concentration in the serum. Iron Deficiency Anemia in Chronic Kidney Disease Not on Dialysis Ferric iron is reduced from the ferric to the ferrous form by ferric reductase in the GI tract. After transport through the enterocytes into the blood, oxidized ferric iron circulates bound to the plasma protein transferrin, and can be incorporated into hemoglobin."],"clinical_pharmacology":["12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action Hyperphosphatemia in Chronic Kidney Disease on Dialysis Ferric iron binds dietary phosphate in the GI tract and precipitates as ferric phosphate. This compound is insoluble and is excreted in the stool. By binding phosphate in the GI tract and decreasing absorption, ferric citrate lowers the phosphate concentration in the serum. Iron Deficiency Anemia in Chronic Kidney Disease Not on Dialysis Ferric iron is reduced from the ferric to the ferrous form by ferric reductase in the GI tract. After transport through the enterocytes into the blood, oxidized ferric iron circulates bound to the plasma protein transferrin, and can be incorporated into hemoglobin. 12.2 Pharmacodynamics Hyperphosphatemia in Chronic Kidney Disease on Dialysis Ferric citrate reduces serum phosphorus levels and has also been shown to increase serum iron parameters, including ferritin, iron and TSAT. In dialysis patients treated with ferric citrate for hyperphosphatemia in a 52-week study in which intravenous iron could also be administered, mean (SD) ferritin levels rose from 593 (293) ng/mL to 895 (482) ng/mL, mean (SD) TSAT levels rose from 31% (11) to 39% (17) and mean (SD) iron levels rose from 73 (29) mcg/dL to 88 (42) mcg/dL. In contrast, in patients treated with active control, these parameters remained relatively constant [see Contraindications (4) and Warnings and Precautions (5.1)] . Iron Deficiency Anemia in Chronic Kidney Disease Not on Dialysis Ferric citrate may increase hemoglobin levels and has also been shown to reduce serum phosphorus levels. In chronic kidney disease patients not on dialysis treated with ferric citrate for iron deficiency anemia in a 16-week placebo-controlled study, mean (SD) phosphorus levels decreased from 4.23 (0.91) mg/dL at baseline to 3.72 (0.60) mg/dL. In comparison, in patients treated with placebo control, mean (SD) phosphorus levels decreased from 4.12 (0.68) mg/dL at baseline to 3.87 (0.68) mg/dL. 12.3 Pharmacokinetics Absorption and Distribution Formal pharmacokinetic studies have not been performed with ferric citrate. Examination of serum iron parameters has shown that there is systemic absorption of iron from ferric citrate [see Contraindications (4), Warnings and Precautions (5.1) and Clinical Pharmacology (12.1)] . Drug Interaction Studies In vitro Of the drugs screened for an interaction with ferric citrate in vitro, only doxycycline showed the potential for interaction with at least 70% decrease in its concentration. This interaction can be avoided by spacing the administration of doxycycline and ferric citrate [see Drug Interactions (7)] . In vivo Six drug interaction studies (N=26 to 60/study) were conducted to establish the effects of ferric citrate (administered as 3 x 2 g/day with meals) on the disposition of concomitantly orally administered clopidogrel, ciprofloxacin, digoxin, diltiazem, glimepiride and losartan in healthy subjects. With the exception of ciprofloxacin, ferric citrate did not alter the systemic exposure of the tested drugs, as measured by the area under the curve (AUC) and C max of the tested drugs when either co-administered with ferric citrate or given 2 hours later. Ferric citrate decreased the relative bioavailability of concomitantly administered ciprofloxacin by approximately 45%. However, there was no interaction when ferric citrate and ciprofloxacin were taken 2 hours apart. Consequently, ciprofloxacin should be taken at least 2 hours before or after ferric citrate is dosed [see Drug Interactions (7)] ."],"indications_and_usage":["1 INDICATIONS AND USAGE Ferric citrate tablets are a phosphate binder indicated for the control of serum phosphorus levels in adult patients with chronic kidney disease on dialysis. ( 1 ) Ferric citrate tablets are an iron replacement product indicated for the treatment of iron deficiency anemia in adult patients with chronic kidney disease not on dialysis. ( 1 ) 1.1 Hyperphosphatemia in Chronic Kidney Disease on Dialysis Ferric citrate tablets are indicated for the control of serum phosphorus levels in adult patients with chronic kidney disease on dialysis. 1.2 Iron Deficiency Anemia in Chronic Kidney Disease Not on Dialysis Ferric citrate tablets are indicated for the treatment of iron deficiency anemia in adult patients with chronic kidney disease not on dialysis."],"warnings_and_cautions":["5 WARNINGS AND PRECAUTIONS Iron overload: Monitor ferritin and TSAT. Patients may require a reduction in dose or discontinuation of intravenous iron. ( 5.1 ) Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6 years of age. Keep this product out of reach of children. In case of accidental overdose, call a doctor or poison control center immediately. ( 5.2 ) 5.1 Iron Overload Iron absorption from ferric citrate may lead to excessive elevations in iron stores. Increases in serum ferritin and transferrin saturation (TSAT) levels were observed in clinical trials. In a 56-week safety and efficacy trial evaluating the control of serum phosphate levels in patients with chronic kidney disease on dialysis in which concomitant use of intravenous iron was permitted, 55 (19%) of patients treated with ferric citrate had a ferritin level >1500 ng/mL as compared with 13 (9%) of patients treated with active control. Assess iron parameters (e.g., serum ferritin and TSAT) prior to initiating ferric citrate and monitor iron parameters while on therapy [see Contraindications (4), Overdosage (10) and Clinical Pharmacology (12.2)] . Patients receiving intravenous iron may require a reduction in dose or discontinuation of intravenous iron therapy. 5.2 Risk of Overdosage in Children Due to Accidental Ingestion Accidental ingestion and resulting overdose of iron-containing products is a leading cause of fatal poisoning in children under 6 years of age [see Overdosage (10)] . Advise patients of the risks to children and to keep ferric citrate tablets out of the reach of children."],"clinical_studies_table":["
Table 3: Effect of Ferric Citrate on serum phosphorus during randomized withdrawal
Primary Endpoint (Week 56)Ferric CitratePlaceboTreatment Difference (95% CI)p-value
Serum phosphorus (mg/dL) Mean baseline (Week 52) Mean change from baseline (Week 56)5.12−0.245.441.79−2.18 (−2.59, −1.77)<0.0001a
a The LS mean treatment difference and p-value for the change in mean were created via an ANCOVA model with treatment as the fixed effect and Week-52 baseline (phosphorus) as the covariate. Between-treatment differences were calculated as the LS mean (ferric citrate) – LS mean (placebo or active control).
","
Table 4: Efficacy of Ferric Citrate in Iron Deficiency Anemia in Chronic Kidney Disease (Not on Dialysis)
Ferric Citrate (N=117)Placebo (N=115)p-value
Proportion of patients achieving an increase in hemoglobin of ≥1.0 g/dL at any time point during the 16 week randomized period52%19%<0.001
"],"nonclinical_toxicology":["13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility Data from carcinogenesis studies have shown that ferric citrate is not carcinogenic in mice and rats when administered intramuscularly or subcutaneously. Ferric citrate was neither mutagenic in the bacterial reverse mutation assay (Ames test) nor clastogenic in the chromosomal aberration test in Chinese hamster fibroblasts. The potential for ferric citrate to impair reproductive performance or to cause fetal malformation has not been evaluated."],"adverse_reactions_table":["
Table 1: Adverse Reactions Reported in Two Clinical Trials in at least 5% of patients receiving Ferric Citrate
Body SystemAdverse ReactionFerric Citrate % (N=190)Placebo % (N=188)
Any Adverse Reaction7562
Metabolism and Nutrition Disorders
Hyperkalemia53
Gastrointestinal Disorders
Discolored Feces 220
Diarrhea2112
Constipation1810
Nausea104
Abdominal Pain52
"],"drug_interactions_table":["
Table 2: Oral drugs that can be administered concomitantly with ferric citrate
AmlodipineAspirinAtorvastatinCalcitriolClopidogrelDigoxinDiltiazem Doxercalciferol Enalapril Fluvastatin Glimepiride Levofloxacin LosartanMetoprololPravastatin PropranololSitagliptinWarfarin
Oral drugs that have to be separated from ferric citrate and meals
Dosing Recommendations
DoxycyclineTake at least 1 hour before ferric citrate
CiprofloxacinTake at least 2 hours before or after ferric citrate
"],"information_for_patients":["17 PATIENT COUNSELING INFORMATION Dosing Recommendations Instruct patients to take ferric citrate tablets as directed with meals and adhere to their prescribed diets. Instruct patients on concomitant medications that should be dosed apart from ferric citrate tablets [see Dosage and Administration (2)] . Instruct patients to swallow the tablets whole, not to chew or crush ferric citrate tablets because it may cause discoloration of mouth and teeth. Adverse Reactions Advise patients that ferric citrate tablets may cause discolored (dark) stools, but this staining of the stool is considered normal with oral medications containing iron. Ferric citrate tablets may cause diarrhea, nausea, constipation, vomiting, hyperkalemia, abdominal pain, and cough. Advise patients to report severe or persistent gastrointestinal symptoms to their physician [see Adverse Reactions (6.1)] . Accidental Ingestion Advise patients to keep this product out of the reach of children and to seek immediate medical attention in case of accidental ingestion by a child. Manufactured In India By: Watson Pharma Private Limited Verna, Salcette Goa 403 722 India Manufactured For: Teva Pharmaceuticals Parsippany, NJ 07054 Iss. 11/2024"],"dosage_and_administration":["2 DOSAGE AND ADMINISTRATION Hyperphosphatemia in Chronic Kidney Disease on Dialysis: Starting dose is 2 tablets orally 3 times per day with meals. ( 2.1 ) Adjust dose by 1 to 2 tablets as needed to maintain serum phosphorus at target levels, up to a maximum of 12 tablets daily. Dose can be titrated at 1-week or longer intervals. ( 2.1 ) Iron Deficiency Anemia in Chronic Kidney Disease Not on Dialysis: Starting dose is 1 tablet orally 3 times per day with meals. ( 2.2 ) Adjust dose as needed to achieve and maintain hemoglobin goal, up to a maximum of 12 tablets daily. ( 2.2 ) 2.1 Dosage for Hyperphosphatemia in Chronic Kidney Disease on Dialysis The recommended starting dose is 2 tablets, swallowed whole, 3 times per day with meals. Ferric citrate tablets must not be chewed or crushed because it may cause discoloration of mouth and teeth. Monitor serum phosphorus levels and titrate the ferric citrate tablet dose in decrements or increments of 1 to 2 tablets per day as needed to maintain serum phosphorus at target levels, up to a maximum dose of 12 tablets daily. Dose can be titrated at 1-week or longer intervals. In a clinical trial, patients required an average of 8 to 9 tablets a day to control serum phosphorus levels. 2.2 Dosage for Iron Deficiency Anemia in Chronic Kidney Disease Not on Dialysis The recommended starting dose is 1 tablet, swallowed whole, 3 times per day with meals. Ferric citrate tablets must not be chewed or crushed because it may cause discoloration of mouth and teeth. Titrate the dose of ferric citrate tablets as needed to achieve and maintain hemoglobin at target levels, up to a maximum dose of 12 tablets daily. In a clinical trial in patients with chronic kidney disease not on dialysis (CKD-NDD), patients required an average of 5 tablets per day to increase hemoglobin levels."],"spl_product_data_elements":["Ferric Citrate Ferric Citrate FERRIC CITRATE FERRIC CATION CALCIUM STEARATE FD&C BLUE NO. 2 ALUMINUM LAKE FD&C RED NO. 40 ALUMINUM LAKE FD&C YELLOW NO. 6 ALUMINUM LAKE HYPROMELLOSE 2910 (6 MPA.S) POLYETHYLENE GLYCOL 4000 STARCH, CORN TITANIUM DIOXIDE W824;TEVA"],"dosage_forms_and_strengths":["3 DOSAGE FORMS AND STRENGTHS Tablets: Each pink, film-coated, oval tablet debossed with “W824” on one side and “TEVA” on the other side contains 210 mg ferric iron equivalent to 1 g ferric citrate. Tablets: 210 mg ferric iron, equivalent to 1 g ferric citrate. ( 3 )"],"use_in_specific_populations":["8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Risk Summary There are no available data on ferric citrate use in pregnant women to inform a drug-associated risk of major birth defects and miscarriage. Animal reproduction studies have not been conducted using ferric citrate. Skeletal and encephalic malformation was observed in neonatal mice when ferric gluconate was administered intraperitoneally to gravid dams on gestation days 7 to 9. However, oral administration of other ferric or ferrous compounds to gravid CD1-mice and Wistar-rats caused no fetal malformation. An overdose of iron in pregnant women may carry a risk for spontaneous abortion, gestational diabetes and fetal malformation. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. Adverse outcomes in pregnancy occur regardless of the health of the mother or the use of medications. In the U.S. general population, the estimated background risks of major birth defects and miscarriage in clinically recognized pregnancies are 2% to 4% and 15% to 20%, respectively. Clinical Considerations The effect of ferric citrate on the absorption of vitamins and other nutrients has not been studied in pregnant women. Requirements for vitamins and other nutrients are increased in pregnancy. 8.2 Lactation Risk Summary There are no human data regarding the effect of ferric citrate in human milk, the effects on the breastfed child, or the effects on milk production. Data from rat studies have shown the transfer of iron into milk by divalent metal transporter-1 (DMT-1) and ferroportin-1 (FPN-1). Hence, there is a possibility of infant exposure when ferric citrate is administered to a nursing woman. The development and health benefits of breastfeeding should be considered along with the mother’s clinical need for ferric citrate and any potential adverse effects on the breastfed child from ferric citrate or from the underlying maternal condition. 8.4 Pediatric Use The safety and efficacy of ferric citrate has not been established in pediatric patients. Juvenile Animal Toxicity Data In animal studies, greater gastrointestinal toxicity was observed when ferric citrate was administered by gavage as compared to administration with solid food. Because ferric citrate is recommended to be taken with meals and patients under 6 months of age are unlikely to be eating solid food, they may be at greater risk of gastrointestinal toxicity. 8.5 Geriatric Use Clinical studies of ferric citrate included 292 subjects aged 65 years and older (104 subjects aged 75 years and older). Overall, the clinical study experience has not identified any obvious differences in responses between the elderly and younger patients in the tolerability or efficacy of ferric citrate."],"package_label_principal_display_panel":["PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 0480-2996-97 Ferric Citrate Tablets 210 mg* WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of the reach of children. In case of accidental overdose, call a doctor or poison control center immediately. Rx only 200 Tablets 1"],"carcinogenesis_and_mutagenesis_and_impairment_of_fertility":["13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility Data from carcinogenesis studies have shown that ferric citrate is not carcinogenic in mice and rats when administered intramuscularly or subcutaneously. Ferric citrate was neither mutagenic in the bacterial reverse mutation assay (Ames test) nor clastogenic in the chromosomal aberration test in Chinese hamster fibroblasts. The potential for ferric citrate to impair reproductive performance or to cause fetal malformation has not been evaluated."]},"tags":[{"label":"ferric citrate","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"V03AE08","category":"atc"},{"label":"Generic Available","category":"availability"},{"label":"LOE Approaching","category":"status"},{"label":"Hyperphosphatemia","category":"indication"},{"label":"Iron deficiency anemia","category":"indication"},{"label":"Keryx Biopharms","category":"company"},{"label":"Approved 2010s","category":"decade"}],"phase":"marketed","safety":{"boxedWarnings":[],"safetySignals":[{"date":"","signal":"DIARRHOEA","source":"FDA FAERS","actionTaken":"293 reports"},{"date":"","signal":"SERUM FERRITIN INCREASED","source":"FDA FAERS","actionTaken":"228 reports"},{"date":"","signal":"TRANSFERRIN SATURATION INCREASED","source":"FDA FAERS","actionTaken":"169 reports"},{"date":"","signal":"FAECES DISCOLOURED","source":"FDA FAERS","actionTaken":"117 reports"},{"date":"","signal":"DEATH","source":"FDA FAERS","actionTaken":"112 reports"},{"date":"","signal":"CONSTIPATION","source":"FDA FAERS","actionTaken":"82 reports"},{"date":"","signal":"NAUSEA","source":"FDA FAERS","actionTaken":"70 reports"},{"date":"","signal":"DRUG INEFFECTIVE","source":"FDA FAERS","actionTaken":"69 reports"},{"date":"","signal":"VOMITING","source":"FDA FAERS","actionTaken":"64 reports"},{"date":"","signal":"CHRONIC KIDNEY DISEASE","source":"FDA FAERS","actionTaken":"59 reports"}],"drugInteractions":[{"url":"/drug/dolutegravir","drug":"dolutegravir","action":"Monitor closely","effect":"May interact with Dolutegravir, Iron","source":"DrugCentral","drugSlug":"dolutegravir"},{"url":"/drug/enoxacin","drug":"enoxacin","action":"Monitor closely","effect":"May interact with Enoxacin, Iron","source":"DrugCentral","drugSlug":"enoxacin"},{"url":"/drug/levodopa","drug":"levodopa","action":"Monitor closely","effect":"May interact with Iron, Levodopa","source":"DrugCentral","drugSlug":"levodopa"},{"url":"/drug/levofloxacin","drug":"levofloxacin","action":"Monitor closely","effect":"May interact with Iron, Levofloxacin","source":"DrugCentral","drugSlug":"levofloxacin"},{"url":"/drug/levothyroxine-sodium","drug":"levothyroxine sodium","action":"Monitor closely","effect":"May interact with Iron, Levothyroxine Sodium","source":"DrugCentral","drugSlug":"levothyroxine-sodium"},{"url":"/drug/lomefloxacin","drug":"lomefloxacin","action":"Monitor closely","effect":"May interact with Iron, Lomefloxacin","source":"DrugCentral","drugSlug":"lomefloxacin"},{"url":"/drug/minocycline","drug":"minocycline","action":"Monitor closely","effect":"May interact with Iron, Minocycline","source":"DrugCentral","drugSlug":"minocycline"},{"url":"/drug/moxifloxacin","drug":"moxifloxacin","action":"Monitor closely","effect":"May interact with Iron, Moxifloxacin","source":"DrugCentral","drugSlug":"moxifloxacin"},{"url":"/drug/mycophenolate-mofetil","drug":"mycophenolate mofetil","action":"Monitor closely","effect":"May interact with Iron, Mycophenolate Mofetil","source":"DrugCentral","drugSlug":"mycophenolate-mofetil"},{"url":"/drug/norfloxacin","drug":"norfloxacin","action":"Monitor closely","effect":"May interact with Iron, Norfloxacin","source":"DrugCentral","drugSlug":"norfloxacin"},{"url":"/drug/ofloxacin","drug":"ofloxacin","action":"Monitor closely","effect":"May interact with Iron, Ofloxacin","source":"DrugCentral","drugSlug":"ofloxacin"}],"commonSideEffects":[{"effect":"Discolored feces","drugRate":"22%","severity":"common","organSystem":""},{"effect":"Diarrhea","drugRate":"21%","severity":"common","organSystem":""},{"effect":"Constipation","drugRate":"18%","severity":"common","organSystem":""},{"effect":"Nausea","drugRate":"11%","severity":"common","organSystem":""},{"effect":"Vomiting","drugRate":"7%","severity":"common","organSystem":""},{"effect":"Cough","drugRate":"6%","severity":"common","organSystem":""},{"effect":"Abdominal pain","drugRate":"5%","severity":"common","organSystem":""},{"effect":"Hyperkalemia","drugRate":"5%","severity":"common","organSystem":""}],"seriousAdverseEvents":[]},"trials":[],"aliases":[],"company":"Keryx Biopharms","patents":[{"applNo":"N205874","source":"FDA Orange Book","status":"Active","expires":"Apr 21, 2026","useCode":"U-1577","territory":"US","drugProduct":false,"patentNumber":"8093423","drugSubstance":false},{"applNo":"N205874","source":"FDA Orange Book","status":"Active","expires":"Jul 21, 2030","useCode":"U-2549","territory":"US","drugProduct":false,"patentNumber":"10300039","drugSubstance":false},{"applNo":"N205874","source":"FDA Orange Book","status":"Active","expires":"Jul 21, 2030","useCode":"","territory":"US","drugProduct":true,"patentNumber":"9387191","drugSubstance":false}],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=FERRIC CITRATE","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T00:37:27.790148+00:00"},"patents":{"url":"","method":"deterministic","source":"FDA Orange Book","rawText":"","confidence":1,"sourceType":"fda_orange_book","retrievedAt":"2026-04-20T00:37:27.790069+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T00:37:33.277586+00:00"},"regulatory.us":{"url":"","method":"api_direct","source":"FDA Drugs@FDA","rawText":"","confidence":1,"sourceType":"fda_drugsfda","retrievedAt":"2026-04-20T00:37:26.679199+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=FERRIC CITRATE","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T00:37:33.684191+00:00"},"administration.route":{"url":"","method":"deterministic","source":"FDA Label","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T00:37:25.217899+00:00"},"safety.boxedWarnings":{"url":"","method":"deterministic","source":"FDA Label (no boxed warning)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T00:37:25.217932+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":"2026-04-20T00:37:35.336159+00:00"},"mechanism.target_chembl":{"url":"","method":"api_direct","source":"ChEMBL mechanism: Phosphate sequestering agent","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T00:37:34.897777+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL3301597/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T00:37:34.559090+00:00"},"regulatory.fda_application":{"url":"","method":"deterministic","source":"FDA Label","rawText":"ANDA212563","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T00:37:25.217936+00:00"}},"allNames":"auryxia","offLabel":[],"synonyms":["fexeric","ferric citrate hydrate","ferric citrate","ferric citrate trihydrate"],"timeline":[{"date":"2014-01-01","type":"neutral","source":"FDA Orange Book","milestone":"Rights transferred from KERYX BIOPHARMS to Keryx Biopharms"},{"date":"2014-09-05","type":"positive","source":"DrugCentral","milestone":"FDA approval (Keryx Biopharms)"},{"date":"2021-03-23","type":"positive","source":"DrugCentral","milestone":"PMDA approval (Japan Tobacco Inc.)"},{"date":"2026-03-11","type":"neutral","source":"FDA Orange Book","milestone":"Generic entry — 1 manufacturer approved"}],"aiSummary":"Auryxia (FERRIC CITRATE) is a small molecule drug developed by Keryx Biopharms, currently owned by the same company. It is used to treat hyperphosphatemia and iron deficiency anemia. Auryxia is a ferric citrate, a type of iron replacement therapy. It is FDA-approved and has a commercial status of patented, with a generic manufacturer available. Key safety considerations include monitoring of serum phosphorus levels and potential gastrointestinal side effects.","approvals":[{"date":"2014-09-05","orphan":false,"company":"KERYX BIOPHARMS","regulator":"FDA"},{"date":"2021-03-23","orphan":false,"company":"Japan Tobacco Inc.","regulator":"PMDA"}],"brandName":"Auryxia","ecosystem":[{"indication":"Hyperphosphatemia","otherDrugs":[{"name":"sucroferric oxyhydroxide","slug":"sucroferric-oxyhydroxide","company":"Vifor Fresenius"}],"globalPrevalence":null},{"indication":"Iron deficiency anemia","otherDrugs":[{"name":"cyanocobalamin","slug":"cyanocobalamin","company":""},{"name":"docusate sodium","slug":"docusate-sodium","company":""},{"name":"ferric carboxymaltose","slug":"ferric-carboxymaltose","company":"Luitpold"},{"name":"ferric derisomaltose","slug":"ferric-derisomaltose","company":"Pharmacosmos As"}],"globalPrevalence":null}],"mechanism":{"novelty":"Follow-on","modality":"Small Molecule","drugClass":"ferric citrate","explanation":"Imagine your body as a bucket with two separate compartments: one for phosphate and one for iron. Auryxia helps by filling the iron compartment, while also using a special 'mop' to clean up excess phosphate in the gut, preventing it from entering the body.","oneSentence":"Auryxia works by binding to phosphate in the gut, reducing its absorption, and also providing iron to the body.","technicalDetail":"Auryxia (ferric citrate) acts as a phosphate binder in the gastrointestinal tract, reducing phosphate absorption, and also provides iron through the release of ferric ions, which are then absorbed by the body."},"commercial":{"launchDate":"2014","_launchSource":"DrugCentral (FDA 2014-09-05, KERYX BIOPHARMS)"},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/4538","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=FERRIC%20CITRATE","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=FERRIC CITRATE","fields":["publications"],"source":"PubMed/NCBI"},{"id":4,"url":"https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files","fields":["patents","exclusivity","genericManufacturers"],"source":"FDA Orange Book"}],"_enrichedAt":"2026-03-30T14:55:37.811667","_validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T00:37:38.375982+00:00","fieldsConflicting":0,"overallConfidence":0.95},"biosimilars":[],"competitors":[{"drugName":"sodium polystyrene sulfonate","drugSlug":"sodium-polystyrene-sulfonate","fdaApproval":"1958-06-05","genericCount":14,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"sevelamer","drugSlug":"sevelamer","fdaApproval":"1998-10-30","genericCount":6,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"lanthanum carbonate","drugSlug":"lanthanum-carbonate","fdaApproval":"2004-10-26","patentExpiry":"Dec 1, 2030","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"sucroferric oxyhydroxide","drugSlug":"sucroferric-oxyhydroxide","fdaApproval":"2013-11-27","relationship":"same-class"},{"drugName":"calcium acetate","drugSlug":"calcium-acetate","fdaApproval":"1982-05-06","patentExpiry":"Jul 20, 2027","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"patiromer calcium","drugSlug":"patiromer-calcium","fdaApproval":"2015-10-21","relationship":"same-class"},{"drugName":"sodium zirconium cyclosilicate","drugSlug":"sodium-zirconium-cyclosilicate","fdaApproval":"2018-05-18","patentExpiry":"Oct 22, 2033","patentStatus":"Patent protected","relationship":"same-class"}],"genericName":"ferric citrate","indications":{"approved":[{"name":"Hyperphosphatemia","source":"DrugCentral","snomedId":20165001,"regulator":"FDA"},{"name":"Iron deficiency anemia","source":"DrugCentral","snomedId":87522002,"regulator":"FDA"}],"offLabel":[],"pipeline":[]},"currentOwner":"Keryx Biopharms","drugCategory":"loe-approaching","labelChanges":[],"relatedDrugs":[{"drugId":"sodium-polystyrene-sulfonate","brandName":"sodium polystyrene sulfonate","genericName":"sodium polystyrene sulfonate","approvalYear":"1958","relationship":"same-class"},{"drugId":"sevelamer","brandName":"sevelamer","genericName":"sevelamer","approvalYear":"1998","relationship":"same-class"},{"drugId":"lanthanum-carbonate","brandName":"lanthanum carbonate","genericName":"lanthanum carbonate","approvalYear":"2004","relationship":"same-class"},{"drugId":"sucroferric-oxyhydroxide","brandName":"sucroferric oxyhydroxide","genericName":"sucroferric oxyhydroxide","approvalYear":"2013","relationship":"same-class"},{"drugId":"calcium-acetate","brandName":"calcium acetate","genericName":"calcium acetate","approvalYear":"1982","relationship":"same-class"},{"drugId":"patiromer-calcium","brandName":"patiromer calcium","genericName":"patiromer calcium","approvalYear":"2015","relationship":"same-class"},{"drugId":"sodium-zirconium-cyclosilicate","brandName":"sodium zirconium cyclosilicate","genericName":"sodium zirconium cyclosilicate","approvalYear":"2018","relationship":"same-class"}],"trialDetails":[{"nctId":"NCT04523727","phase":"PHASE3","title":"Study to Evaluate the Safety and Tolerability of Ferric Citrate in Children With Hyperphosphatemia Related to Chronic Kidney Disease","status":"SUSPENDED","sponsor":"Keryx Biopharmaceuticals","startDate":"2022-06-16","conditions":["Hyperphosphatemia Related to Chronic Kidney Disease"],"enrollment":45,"completionDate":"2027-10"},{"nctId":"NCT07381426","phase":"PHASE3","title":"Ferric Citrate in Iron Deficiency Anemia During Pregnancy","status":"NOT_YET_RECRUITING","sponsor":"Dhaka Medical College","startDate":"2026-02-01","conditions":["Anemia"],"enrollment":680,"completionDate":"2027-03-31"},{"nctId":"NCT04649411","phase":"PHASE3","title":"Study to Evaluate the Safety and Tolerability of KRX-0502 (Ferric Citrate) in Children With Iron Deficiency Anemia Associated With Non-Dialysis Dependent Chronic Kidney Disease","status":"WITHDRAWN","sponsor":"Keryx Biopharmaceuticals","startDate":"2025-01","conditions":["Iron Deficiency Anemia Associated With Non-Dialysis Dependent Chronic Kidney Disease"],"enrollment":0,"completionDate":"2027-03"},{"nctId":"NCT05085275","phase":"PHASE3","title":"Ferric Citrate for the Prevention of Renal Failure in Adults With Advanced Chronic Kidney Disease","status":"COMPLETED","sponsor":"USRC Kidney Research","startDate":"2022-03-30","conditions":["Anemia, Iron Deficiency","Hyperphosphatemia","Renal Insufficiency, Chronic","Renal Anemia","Disease Progression","Cardiovascular","Iron"],"enrollment":289,"completionDate":"2024-01-24"},{"nctId":"NCT06869824","phase":"NA","title":"The Efficacy of Minayo Iron-rich Nutritional Gummies on Female Anemia, Skin Condition and Qi-blood Deficiency Syndrome","status":"COMPLETED","sponsor":"Hangzhou Agile Groups Network Technology Co., Ltd.","startDate":"2025-03-17","conditions":["Anemia","Skin Condition","Qi-blood Deficiency Syndrome"],"enrollment":36,"completionDate":"2025-04-13"},{"nctId":"NCT04543812","phase":"PHASE3","title":"PBF-1681 (Ferric Citrate) for the Treatment of IDA in Patients With NDD-CKD","status":"COMPLETED","sponsor":"Panion & BF Biotech Inc.","startDate":"2020-10-14","conditions":["Anemia of Chronic Kidney Disease"],"enrollment":141,"completionDate":"2022-12-16"},{"nctId":"NCT04741646","phase":"PHASE2","title":"Ferric Citrate and Chronic Kidney Disease in Children","status":"RECRUITING","sponsor":"University of California, Los Angeles","startDate":"2022-06-17","conditions":["Chronic Kidney Diseases"],"enrollment":160,"completionDate":"2027-10"},{"nctId":"NCT04456803","phase":"PHASE3","title":"Ferric Citrate for the Treatment of Hyperphosphatemia in Patients With Chronic Kidney Disease Undergoing Hemodialysis","status":"COMPLETED","sponsor":"Sinomune Pharmaceutical Co., Ltd","startDate":"2019-05-24","conditions":["Hyperphosphatemia","End Stage Renal Disease","ESRD"],"enrollment":239,"completionDate":"2022-09-13"},{"nctId":"NCT03457701","phase":"PHASE2","title":"Anemia Studies in CKD: Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor (PHI) Daprodustat- Iron (ASCEND: Fe)","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2019-07-30","conditions":["Anaemia"],"enrollment":15,"completionDate":"2022-07-05"},{"nctId":"NCT02661295","phase":"PHASE4","title":"A Study of Ferric Citrate to Improve Inflammation and Lipid Levels","status":"TERMINATED","sponsor":"Winthrop University Hospital","startDate":"2015-07","conditions":["End Stage Renal Disease","Hyperphosphatemia","Chronic Inflammation"],"enrollment":38,"completionDate":"2018-03-15"},{"nctId":"NCT03824587","phase":"PHASE2,PHASE3","title":"Study to Evaluate the Efficacy of Tenapanor as Adjunctive Therapy to Phosphate Binder Therapy","status":"COMPLETED","sponsor":"Ardelyx","startDate":"2019-02-28","conditions":["Hyperphosphatemia"],"enrollment":236,"completionDate":"2019-07-17"},{"nctId":"NCT04922645","phase":"PHASE4","title":"Auryxia (Ferric Citrate) Therapy for In-Center and Home Dialysis Participants","status":"COMPLETED","sponsor":"USRC Kidney Research","startDate":"2021-06-29","conditions":["Hyperphosphatemia","Anemia, Iron Deficiency","Renal Insufficiency"],"enrollment":214,"completionDate":"2022-09-15"},{"nctId":"NCT04640168","phase":"PHASE3","title":"Adaptive COVID-19 Treatment Trial 4 (ACTT-4)","status":"COMPLETED","sponsor":"National Institute of Allergy and Infectious Diseases (NIAID)","startDate":"2020-12-02","conditions":["COVID-19"],"enrollment":1010,"completionDate":"2021-06-18"},{"nctId":"NCT04689932","phase":"PHASE4","title":"Triferic AVNU Infusion Via Freedom Pump During Hemodialysis","status":"COMPLETED","sponsor":"Rockwell Medical Technologies, Inc.","startDate":"2021-04-19","conditions":["End Stage Renal Disease"],"enrollment":12,"completionDate":"2021-06-19"},{"nctId":"NCT03079869","phase":"PHASE4","title":"Transition to Ferric Citrate Among Hemodialysis and Peritoneal Dialysis Patients","status":"COMPLETED","sponsor":"Kaiser Permanente","startDate":"2017-05-01","conditions":["Hyperphosphatemia"],"enrollment":55,"completionDate":"2019-09-14"},{"nctId":"NCT05110768","phase":"PHASE2","title":"Treatment of (IDA) by (FPC) Delivered Via Infusion Pump in Patients Receiving Home Infusion Therapy","status":"UNKNOWN","sponsor":"Rockwell Medical Technologies, Inc.","startDate":"2021-11-30","conditions":["Iron Deficiency Anemia"],"enrollment":75,"completionDate":"2022-05-30"},{"nctId":"NCT04721964","phase":"NA","title":"Evaluation of the Effects of Routine Iron Supplementation in Children on Gastrointestinal Iron Losses","status":"COMPLETED","sponsor":"Swiss Federal Institute of Technology","startDate":"2021-02-25","conditions":["Iron Deficiency Anemia","Gastro Intestinal Bleeding","Iron-deficiency"],"enrollment":24,"completionDate":"2021-06-16"},{"nctId":"NCT04409132","phase":"PHASE1,PHASE2","title":"Study to Investigate the Pharmacokinetic Comparability of Dosing Triferic AVNU IV by Continuous Infusion and IV Bolus.","status":"COMPLETED","sponsor":"Rockwell Medical Technologies, Inc.","startDate":"2020-06-25","conditions":["End Stage Renal Disease"],"enrollment":23,"completionDate":"2021-04-02"},{"nctId":"NCT04239391","phase":"PHASE3","title":"Hemoglobin Maintenance in Pediatric ESRD (End-stage Renal Disease) Patients by Ferric Pyrophosphate Citrate (FPC)","status":"UNKNOWN","sponsor":"Rockwell Medical Technologies, Inc.","startDate":"2020-09-01","conditions":["End Stage Renal Disease"],"enrollment":150,"completionDate":"2023-11-01"},{"nctId":"NCT03236246","phase":"PHASE4","title":"KRX-0502 (Ferric Citrate) in Subjects With NDD-CKD and IDA (The COMPASS Trial)","status":"COMPLETED","sponsor":"Keryx Biopharmaceuticals","startDate":"2017-08-15","conditions":["Chronic Kidney Diseases","Iron Deficiency Anemia"],"enrollment":206,"completionDate":"2019-09-27"},{"nctId":"NCT03984760","phase":"PHASE3","title":"Ferric Citrate for the Treatment of Hyperphosphatemia in Patients With Chronic Kidney Disease Undergoing Hemodialysis","status":"COMPLETED","sponsor":"Panion & BF Biotech Inc.","startDate":"2019-06-19","conditions":["Hyperphosphatemia","End Stage Renal Disease","ESRD"],"enrollment":240,"completionDate":"2021-02-20"},{"nctId":"NCT04042324","phase":"PHASE1,PHASE2","title":"A Study to Investigate the Effect of Triferic Plus Heparin Infusion Compared to Heparin Alone on Coagulation Parameters in Hemodialysis Patients","status":"COMPLETED","sponsor":"Rockwell Medical Technologies, Inc.","startDate":"2019-09-30","conditions":["End Stage Renal Disease"],"enrollment":12,"completionDate":"2020-01-16"},{"nctId":"NCT03303144","phase":"PHASE1,PHASE2","title":"Equivalence of Triferic® (Ferric Pyrophosphate Citrate) Administered Via Hemodialysate and Intravenously to Adult CKD-5HD Patients","status":"COMPLETED","sponsor":"Rockwell Medical Technologies, Inc.","startDate":"2017-10-01","conditions":["End Stage Renal 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