Prescription medicine
Ferric citrate First approved as Auryxia
Ferric citrate (Auryxia) is a prescription medicine with an FDA approval on record since 2014. FDA's NDC Directory lists it from 1 generic labeler.
- Generic listed
Check it at the source: the ferric citrate FDA label on DailyMed (effective November 1, 2024, Teva Pharmaceuticals, Inc.); the NDA 205874 record on Drugs@FDA; every ferric citrate label on DailyMed.
Highlights of the record
FDA label of November 1, 2024; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageFerric citrate tablets are a phosphate binder indicated for the control of serum phosphorus levels in adult patients with chronic kidney disease on dialysis.
Forms and strengths
- 210 mg
Film-coated tablet.
On the market
- Earliest approval on file
- September 5, 2014 Auryxia, Keryx Biopharms; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 1 first March 11, 2026; 1 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 1 of which 1 under generic applications, 0 under brand applications, repackagers included
- Last listed patent
- July 21, 2030 Auryxia tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 4 since 2017 0 Class I among all firms' recalls; latest March 15, 2021
- FAERS reports
- 2,194 through July 30, 2026
What is ferric citrate used for?
From the label: indications and usageFerric 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. […]
Conditions named in the indications of ferric citrate's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Parenteral Iron Replacement and Phosphate Binder.
Source: FDA drug label (Ferric Citrate), Teva Pharmaceuticals, Inc., effective November 1, 2024 (SPL set 314bd2e4-2ca5-4e2a-9fea-13373f910f34), via openFDA; the full label on DailyMed
Is there a generic for ferric citrate (Auryxia)?
The FDA approved the first generic ferric citrate on March 11, 2026. 1 generic application is approved; 1 of it carries a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists ferric citrate from 1 labeler under a generic (ANDA) application. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists 3 patents for Auryxia tablets, the last expiring on July 21, 2030. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2014 earliest approval on file
- 2026 first generic approved
- 2030 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Has ferric citrate been recalled?
The FDA's Enforcement Report lists 4 recalls naming ferric citrate since 2017: 0 Class I (the most serious), 3 Class II, 1 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| March 15, 2021 | Class II | Cardinal Health Inc. | CGMP Deviations: Intermittent exposure to temperature excursion during storage. |
| December 9, 2020 | Class II | Akebia Therapeutics dba Keryx Biopharmaceutials, Inc | CGMP Deviations |
| July 10, 2020 | Class II | Keryx Biopharmaceuticals, Inc. | cGMP deviations: Lots recalled were not manufactured in conformance with the FDA-approved manufacturing process for Auryxia. |
| December 12, 2017 | Class III | Keryx Biopharmaceuticals, Inc. | Presence of Foreign Substance: Reports have been received of damaged StripPax packets containing silica gel desiccant potentially allowing the silica gel … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the ferric citrate label say about other medicines?
The ferric citrate label names 20 other medicines in its interaction, contraindication or warning sections. The labels of 1 other medicine name ferric citrate. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Amlodipine | drug interactions | Amlodipine Aspirin Atorvastatin Calcitriol Clopidogrel Digoxin Diltiazem Doxercalciferol Enalapril Fluvastatin Glimepiride Levofloxacin Losartan; Metoprolol Pravastatin Propranolol Sitagliptin Warfarin |
| Aspirin | drug interactions | Amlodipine Aspirin Atorvastatin Calcitriol Clopidogrel Digoxin Diltiazem Doxercalciferol Enalapril Fluvastatin Glimepiride Levofloxacin Losartan; Metoprolol Pravastatin Propranolol Sitagliptin Warfarin |
| Atorvastatin | drug interactions | Amlodipine Aspirin Atorvastatin Calcitriol Clopidogrel Digoxin Diltiazem Doxercalciferol Enalapril Fluvastatin Glimepiride Levofloxacin Losartan; Metoprolol Pravastatin Propranolol Sitagliptin Warfarin |
| Calcitriol | drug interactions | Amlodipine Aspirin Atorvastatin Calcitriol Clopidogrel Digoxin Diltiazem Doxercalciferol Enalapril Fluvastatin Glimepiride Levofloxacin Losartan; Metoprolol Pravastatin Propranolol Sitagliptin Warfarin |
| Ciprofloxacin | drug interactions | Ciprofloxacin; Take at least 2 hours before or after ferric citrate |
| Clopidogrel | drug interactions | Amlodipine Aspirin Atorvastatin Calcitriol Clopidogrel Digoxin Diltiazem Doxercalciferol Enalapril Fluvastatin Glimepiride Levofloxacin Losartan; Metoprolol Pravastatin Propranolol Sitagliptin Warfarin |
| Digoxin | drug interactions | Amlodipine Aspirin Atorvastatin Calcitriol Clopidogrel Digoxin Diltiazem Doxercalciferol Enalapril Fluvastatin Glimepiride Levofloxacin Losartan; Metoprolol Pravastatin Propranolol Sitagliptin Warfarin |
| Diltiazem | drug interactions | Amlodipine Aspirin Atorvastatin Calcitriol Clopidogrel Digoxin Diltiazem Doxercalciferol Enalapril Fluvastatin Glimepiride Levofloxacin Losartan; Metoprolol Pravastatin Propranolol Sitagliptin Warfarin |
| Doxercalciferol | drug interactions | Amlodipine Aspirin Atorvastatin Calcitriol Clopidogrel Digoxin Diltiazem Doxercalciferol Enalapril Fluvastatin Glimepiride Levofloxacin Losartan; Metoprolol Pravastatin Propranolol Sitagliptin Warfarin |
| Doxycycline | drug interactions | Doxycycline; Take at least 1 hour before ferric citrate |
| Enalapril | drug interactions | Amlodipine Aspirin Atorvastatin Calcitriol Clopidogrel Digoxin Diltiazem Doxercalciferol Enalapril Fluvastatin Glimepiride Levofloxacin Losartan; Metoprolol Pravastatin Propranolol Sitagliptin Warfarin |
| Fluvastatin | drug interactions | Amlodipine Aspirin Atorvastatin Calcitriol Clopidogrel Digoxin Diltiazem Doxercalciferol Enalapril Fluvastatin Glimepiride Levofloxacin Losartan; Metoprolol Pravastatin Propranolol Sitagliptin Warfarin |
| Glimepiride | drug interactions | Amlodipine Aspirin Atorvastatin Calcitriol Clopidogrel Digoxin Diltiazem Doxercalciferol Enalapril Fluvastatin Glimepiride Levofloxacin Losartan; Metoprolol Pravastatin Propranolol Sitagliptin Warfarin |
| Levofloxacin | drug interactions | Amlodipine Aspirin Atorvastatin Calcitriol Clopidogrel Digoxin Diltiazem Doxercalciferol Enalapril Fluvastatin Glimepiride Levofloxacin Losartan; Metoprolol Pravastatin Propranolol Sitagliptin Warfarin |
Every other medicine the ferric citrate label names
| Medicine named | Section | What the label says |
|---|---|---|
| Losartan | drug interactions | Amlodipine Aspirin Atorvastatin Calcitriol Clopidogrel Digoxin Diltiazem Doxercalciferol Enalapril Fluvastatin Glimepiride Levofloxacin Losartan; … |
| Metoprolol | drug interactions | Amlodipine Aspirin Atorvastatin Calcitriol Clopidogrel Digoxin Diltiazem Doxercalciferol Enalapril Fluvastatin Glimepiride Levofloxacin Losartan; … |
| Pravastatin | drug interactions | … Enalapril Fluvastatin Glimepiride Levofloxacin Losartan; Metoprolol Pravastatin Propranolol Sitagliptin Warfarin |
| Propranolol | drug interactions | … Fluvastatin Glimepiride Levofloxacin Losartan; Metoprolol Pravastatin Propranolol Sitagliptin Warfarin |
| Sitagliptin | drug interactions | … Glimepiride Levofloxacin Losartan; Metoprolol Pravastatin Propranolol Sitagliptin Warfarin |
| Warfarin | drug interactions | … Levofloxacin Losartan; Metoprolol Pravastatin Propranolol Sitagliptin Warfarin |
Source: FDA drug label (Ferric Citrate), Teva Pharmaceuticals, Inc., effective November 1, 2024 (SPL set 314bd2e4-2ca5-4e2a-9fea-13373f910f34), via openFDA; the full label on DailyMed
What do FAERS reports show for ferric citrate?
The FDA Adverse Event Reporting System holds 2,194 reports that list ferric citrate among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 260 are coded as a death and 420 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as ferric citrate?
6 other medicines are given the same way (oral) and in the same FDA class as ferric citrate or labeled mainly for the same use (anemia), the same class first. Anemia lists all 25 medicines labeled for it, by any route. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Tetraferric tricitrate decahydrate | Anemia | none listed | $6.28 per tablet 210 mg tablet | No current entry |
| Eltrombopag | Anemia | 13 labelers | $25.85 per tablet 50 mg tablet | No current entry |
| Prednisolone | Anemia | 23 labelers | $0.568 per mL 15 mg/5 mL solution | No current entry |
| Daprodustat | Anemia | none listed | n/a | No current entry |
| Mitapivat | Anemia | none listed | n/a | No current entry |
| Vadadustat | Anemia | none listed | n/a | No current entry |
Every medicine labeled for the same conditions as ferric citrate
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to ferric citrate
- 6 medicines for the same use
- Other parenteral iron replacements
- the pharmacologic class, with prices and generics
- Ferric citrate side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other