What the label lists and what reports show
Auranofin side effects
Auranofin's FDA label lists its adverse reactions in its own words. FAERS holds 205 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 drug hypersensitivity (18 reports).
- No generic listed
- Boxed warning
Check it at the source: the auranofin FDA label on DailyMed (effective November 8, 2025, Sebela Pharmaceuticals Inc.); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsThe adverse reactions incidences listed below are based on observations of 1) 4,784 RIDAURA treated patients in clinical trials (2,474 U.S., 2,310 foreign), of whom 2,729 were treated more than one year and 573 for more than three years; and 2) postmarketing experience. The highest incidence is during the first six months of treatment; however, reactions can occur after many months of therapy. With rare exceptions, all patients were on concomitant nonsteroidal anti-inflammatory therapy; some of them were also taking low dosages of corticosteroids. Reactions occurring in more than 1% of RIDAURA-treated patients Gastrointestinal: loose stools or diarrhea (47%); abdominal pain (14%); nausea with or without vomiting (10%); constipation; anorexia*; flatulence*; dyspepsia*; dysgeusia. Dermatological: rash (24%); pruritus (17%); hair loss; urticaria. Mucous Membrane: stomatitis (13%); …
Incidence of Adverse Reactions for Specific Categories – 18 Comparative Trials
| Reaction | Ridaura (445 patients) | Injectable Gold (445 patients) |
|---|---|---|
| Proteinuria | 0.9% | 5.4% |
| Rash | 26% | 39% |
| Diarrhea | 42.5% | 13% |
| Stomatitis | 13% | 18% |
| Anemia | 3.1% | 2.7% |
| Leukopenia | 1.3% | 2.2% |
| Thromocytopenia | 0.9% | 2.2% |
| Elevated liver function tests | 1.9% | 1.7% |
| Pulmonary | 0.2% | 0.2% |
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.
Source: FDA drug label, NDA018689 (Legacy), as published by Sebela Pharmaceuticals Inc., effective November 8, 2025 (SPL set 43ba3de1-ab2e-06f6-e054-00144ff8d46c), via openFDA; the full label on DailyMed
What do FAERS reports show?
205 reports list auranofin among the medicines taken, each a report of something that happened, not proof the medicine caused it; 28 are coded as a death and 94 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 22 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.
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?
- Auranofin: 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