What the label lists and what reports show
Rifabutin side effects
Rifabutin's FDA label lists its adverse reactions in its own words. FAERS holds 2,689 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 nausea (167 reports).
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Check it at the source: the rifabutin FDA label on DailyMed (effective September 1, 2026, REMEDYREPACK INC.); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsAdverse Reactions from Clinical Trials Rifabutin capsules were generally well tolerated in the controlled clinical trials. Discontinuation of therapy due to an adverse event was required in 16% of patients receiving rifabutin, compared to 8% of patients receiving placebo in these trials. Primary reasons for discontinuation of rifabutin were rash (4% of treated patients), gastrointestinal intolerance (3%), and neutropenia (2%). The following table enumerates adverse experiences that occurred at a frequency of 1% or greater, among the patients treated with rifabutin in studies 023 and 027.
Table 3 Clinical Adverse Experiences Reported in ≥1% of Patients Treated With Rifabutin
| Adverse event | Rifabutin (n = 566) % | Placebo (n = 580) % |
|---|---|---|
| Abdominal pain | 4 | 3 |
| Asthenia | 1 | 1 |
| Chest pain | 1 | 1 |
| Fever | 2 | 1 |
| Headache | 3 | 5 |
| Pain | 1 | 2 |
| Leucopenia | 10 | 7 |
| Anemia | 1 | 2 |
| Anorexia | 2 | 2 |
| Diarrhea | 3 | 3 |
| Dyspepsia | 3 | 1 |
| Eructation | 3 | 1 |
| Flatulence | 2 | 1 |
| Nausea | 6 | 5 |
| Nausea and vomiting | 3 | 2 |
| Vomiting | 1 | 1 |
| Myalgia | 2 | 1 |
| Insomnia | 1 | 1 |
| Rash | 11 | 8 |
| Taste perversion | 3 | 1 |
| Discolored urine | 30 | 6 |
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, NDA050689 (Pfizer), as published by REMEDYREPACK INC., effective September 1, 2026 (SPL set 25a60937-cbbe-4a50-994f-2ce15203f589), via openFDA; the full label on DailyMed
What do FAERS reports show?
2,689 reports list rifabutin among the medicines taken, each a report of something that happened, not proof the medicine caused it; 304 are coded as a death and 950 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, 10 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?
- Rifabutin: 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