What the label lists and what reports show
Ferric oxyhydroxide side effects
Ferric oxyhydroxide's FDA label: “The most common adverse drug reactions to Velphoro chewable tablets in clinical trials were discolored feces (12%) and diarrhea (6%).” FAERS holds 3,002 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 (315 reports).
- No generic listed
Check it at the source: the ferric oxyhydroxide FDA label on DailyMed (effective April 1, 2026, Fresenius Medical Care Renal Therapies Group, LLC); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsThe most common adverse drug reactions to Velphoro chewable tablets in clinical trials were discolored feces (12%) and diarrhea (6%).
From the label: adverse reactions, continuedThe most common adverse drug reactions to Velphoro chewable tablets in clinical trials were discolored feces (12%) and diarrhea (6%). ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Medical Care Renal Therapies Group, LLC at 1-800-323-5188 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trial Experience Adult Patients 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 rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety data derived from Velphoro clinical trials reflect exposure to Velphoro in 2 active-controlled clinical studies involving a total of 778 adult patients on hemodialysis and 57 adult patients on peritoneal dialysis exposed for up to 55 weeks. Dosage regimens ranged from 250 mg to 3,000 mg per day. In a parallel design, dose-finding study of Velphoro with a treatment duration of 6 weeks in hemodialysis patients, adverse reactions for Velphoro (N=128) were similar to those reported for the active-control group (sevelamer hydrochloride) (N=26), with the exception of discolored feces (12%) which did not occur in the active-control group. Diarrhea was reported in 6% of patients treated with Velphoro.
Source: FDA drug label, Fresenius Medical Care Renal Therapies Group, LLC, effective April 1, 2026 (SPL set 237da26c-f38c-4faa-93ad-735e71c9d0c1), via openFDA; the full label on DailyMed
What do FAERS reports show?
3,002 reports list ferric oxyhydroxide among the medicines taken, each a report of something that happened, not proof the medicine caused it; 1,290 are coded as a death and 548 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 20 reactions below, 3 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?
- Ferric oxyhydroxide: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions