pharmacopeia
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Mechanism of action

Sourced from openFDA

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.

Indications

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  • 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.ICD-10: D64.9, E61.1, N18.9

Contraindications

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  • 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).contraindicated

Dosage & administration

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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.

Warnings & precautions

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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)] .

Adverse reactions

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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%).

Use in specific populations

Sourced from openFDA

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.

Pharmacokinetics

Sourced from openFDA
Metabolism
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)] .

Overdosage

Sourced from openFDA

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.

Approval history

Sourced from openFDA
  • Sep 5, 2014NDANDA205874Keryx Biopharms
  • Mar 11, 2026ANDAANDA212563Teva Pharms Usa

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
2,180 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Diarrhoea30114%
  2. 2Serum Ferritin Increased22810%
  3. 3Transferrin Saturation Increased1697.8%
  4. 4Faeces Discoloured1175.4%
  5. 5Death1125.1%
  6. 6Constipation833.8%
  7. 7Nausea703.2%
  8. 8Drug Ineffective693.2%
  9. 9Vomiting653.0%
  10. 10Chronic Kidney Disease592.7%
  11. 11End Stage Renal Disease582.7%
  12. 12Pruritus552.5%
  13. 13Renal Failure532.4%
  14. 14Off Label Use502.3%
  15. 15Gastrointestinal Haemorrhage482.2%

Literature

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Recent PubMed references pinned to Ferric Citrate as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 47 ClinicalTrials.gov registrations naming Ferric Citrate as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Ferric Citrate work?
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.
What is Ferric Citrate used for?
According to FDA labeling, Ferric Citrate carries indications including: 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.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Ferric Citrate?
Ferric Citrate is classified as Drugs for treatment of hyperkalemia and hyperphosphatemia, Electrolyte Activity, Increased Erythroid Cell Production.
What are the brand names for Ferric Citrate?
Ferric Citrate is marketed under brand names including Auryxia.
What are the contraindications for Ferric Citrate?
Ferric Citrate labeling lists contraindications including: 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).. Always consult the full prescribing information and a clinician.
Note. Data for ferric-citrate is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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