FDA

Ferric Citrate

Approved 11 Mar 2026OralTablet

Indications

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 )

1.1Hyperphosphatemia 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.

1.2Iron 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.

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 )

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 )

5.1Iron 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.

At a glance

Brand name: Ferric Citrate
Route: Oral
Dosage form: Tablet
Applicant: Teva Pharms USA
Status: Prescription
FDA approval: 11 Mar 2026
Application: ANDA212563-001

Indications

1.1Hyperphosphatemia 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.

1.2Iron 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 precautions

5.1Iron Overload

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.

6.1Clinical 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%).

Ferric Citrate

Indications

1.1Hyperphosphatemia in Chronic Kidney Disease on Dialysis

1.2Iron Deficiency Anemia in Chronic Kidney Disease Not on Dialysis

Contraindications

Warnings and precautions

5.1Iron Overload

At a glance

Two medicines in one question?

Ferric Citrate

Indications

1.1Hyperphosphatemia in Chronic Kidney Disease on Dialysis

1.2Iron Deficiency Anemia in Chronic Kidney Disease Not on Dialysis

Contraindications

Warnings and precautions

5.1Iron Overload

At a glance

Two medicines in one question?

5.2Risk of Overdosage in Children Due to Accidental Ingestion

Interactions

Pregnancy and breastfeeding

8.1Pregnancy Risk Summary

Adverse reactions

6.1Clinical Trials Experience

Composition

Official product information