What the label lists and what reports show
Tetraferric tricitrate decahydrate side effects
Tetraferric tricitrate decahydrate's FDA label: “Most common adverse reactions (incidence ≥5%) are discolored feces, diarrhea, constipation, nausea, vomiting, cough, abdominal pain, and hyperkalemia.” FAERS holds 2,194 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is diarrhoea (307 reports).
- No generic listed
Check it at the source: the tetraferric tricitrate decahydrate FDA label on DailyMed (effective December 4, 2024, Akebia Therapeutics, Inc.); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsMost common adverse reactions (incidence ≥5%) are discolored feces, diarrhea, constipation, nausea, vomiting, cough, abdominal pain, and hyperkalemia.
Table 1: Adverse Events Reported in Two Clinical Trials in at least 5% of patients receiving Auryxia
| Body System Adverse Reaction | Auryxia % (N=190) | Placebo % (N=188) |
|---|---|---|
| Any Adverse Reaction | 75 | 62 |
| Hyperkalemia | 5 | 3 |
| Discolored feces | 22 | 0 |
| Diarrhea | 21 | 12 |
| Constipation | 18 | 10 |
| Nausea | 10 | 4 |
| Abdominal Pain | 5 | 2 |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedMost 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 Keryx Biopharmaceuticals at 1-844-445-3799 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 Auryxia 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 Auryxia for up to 28 days in three short-term trials. Across these trials, 557 unique patients were treated with Auryxia; 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 Auryxia. …
Source: FDA drug label, NDA205874 (Keryx Biopharms), as published by Akebia Therapeutics, Inc., effective December 4, 2024 (SPL set aadd18e0-3752-11e4-8510-0800200c9a66), via openFDA; the full label on DailyMed
What do FAERS reports show?
2,194 reports list tetraferric tricitrate decahydrate among the medicines taken, 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. Of the 19 reactions below, 5 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Tetraferric tricitrate decahydrate: the full record
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- Report a side effect to the FDA
- MedWatch
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