Drug · FAERS side-effect profile with label screen
Rifabutin side effects: what 2,689 FDA adverse event reports show
Drug class
Rifamycin Antimycobacterial
FDA label (Established Pharmacologic Class)
Who reports
2,689 reports · 83% serious · 304 with death outcome · 48% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Rifabutin capsules are indicated for the prevention of disseminated Mycobacterium avium complex (MAC) disease in patients with advanced HIV infection.
FDA label, Indications and Usage
What it is
DESCRIPTION Rifabutin capsules, USP for oral administration contain 150 mg of the rifamycin antimycobacterial agent rifabutin, USP, per capsule, along with the inactive ingredients, microcryst.
FDA label, Description section
Boxed warning
None in the current label
How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation.
Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)?
That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.
Causality screen of the 40 strongest signals
Labeled adverse reaction 10Labeled (related wording) 1Reporting / coding artifact 7Not in label — unassessed 22
What the badges mean
- Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
- Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
- Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
- Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.
Strongest disproportionality signals
Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 54 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
Show:
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Drug resistance | 161 | 49.2 42.3–57.2ROR 52.3 · χ² 7,513 / p <1e-300 | 48.6 EB05 42.6 · IC025 +5.2 3/3 methods agree | Reporting / coding artifact | serious PRR 31.3 · 99% clinician | no trial data cached |
| Uveitis | 61 | 35.4 27.6–45.4ROR 36.2 · χ² 1,995 / p <1e-300 | 34.9 EB05 28.1 · IC025 +4.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 22.7 · 98% clinician | no trial data cached |
| Drug level decreased | 41 | 31.4 23.1–42.5ROR 31.9 · χ² 1,172 / p 5e-257 | 30.9 EB05 23.7 · IC025 +4.0 3/3 methods agree | Reporting / coding artifact | serious PRR 22.9 · ♀ 14% (drug 48%) · 95% clinician | no trial data cached |
| Tuberculosis | 50 | 30.4 23.1–40.1ROR 31.0 · χ² 1,389 / p <1e-300 | 30.0 EB05 23.7 · IC025 +4.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 21.1 · 90% clinician | no trial data cached |
| Drug reaction with eosinophilia and systemic symptoms | 82 | 25.1 20.3–31.1ROR 25.9 · χ² 1,870 / p <1e-300 | 24.9 EB05 20.7 · IC025 +4.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 17.4 · ♀ 81% (drug 48%) · 94% clinician | no trial data cached |
| Nephropathy toxic | 26 | 18.2 12.4–26.8ROR 18.4 · χ² 406 / p 1e-90 | 17.9 EB05 12.7 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 13.0 · ♀ 20% (drug 48%) · 92% clinician | no trial data cached |
| Hepatotoxicity (liver damage) | 50 | 17.6 13.4–23.2ROR 17.9 · χ² 767 / p 5e-169 | 17.5 EB05 13.7 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 12.0 · 98% clinician | no trial data cached |
| Acute hepatic failure | 30 | 17.2 12.1–24.6ROR 17.4 · χ² 442 / p 2e-98 | 17.0 EB05 12.3 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious PRR 12.0 · 100% clinician | no trial data cached |
| Lymphopenia | 27 | 15.0 10.3–21.8ROR 15.1 · χ² 338 / p 8e-76 | 14.6 EB05 10.3 · IC025 +2.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 10.8 · ♀ 20% (drug 48%) · 100% clinician | no trial data cached |
| Pulmonary mass | 26 | 13.7 9.3–20.0ROR 13.8 · χ² 292 / p 9e-66 | 13.2 EB05 9.1 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 9.1 | no trial data cached |
| Drug interaction | 263 | 12.9 11.5–14.5ROR 14.2 · χ² 2,904 / p <1e-300 | 12.9 EB05 11.6 · IC025 +3.5 3/3 methods agree | Reporting / coding artifact | serious PRR 8.7 · 95% clinician | no trial data cached |
| Electrocardiogram qt prolonged | 52 | 11.3 8.6–14.8ROR 11.5 · χ² 477 / p 5e-106 | 11.0 EB05 8.5 · IC025 +2.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 8.0 · ♀ 26% (drug 48%) · 98% clinician | no trial data cached |
| Deafness | 37 | 11.0 8.0–15.2ROR 11.2 · χ² 327 / p 2e-73 | 10.5 EB05 7.8 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 8.0 · 92% clinician | no trial data cached |
| Drug intolerance | 128 | 10.4 8.8–12.3ROR 10.9 · χ² 1,080 / p 5e-237 | 10.2 EB05 8.8 · IC025 +3.0 3/3 methods agree | Reporting / coding artifact | serious PRR 5.6 · ♀ 70% (drug 48%) | no trial data cached |
| Hepatic cytolysis | 16 | 10.2 6.3–16.7ROR 10.3 · χ² 124 / p 4e-29 | 8.9 EB05 5.5 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 7.1 | no trial data cached |
| Leukopenia (low white blood cells) | 64 | 10.0 7.9–12.8ROR 10.2 · χ² 511 / p 2e-113 | 9.7 EB05 7.8 · IC025 +2.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.2 · 94% clinician | no trial data cached |
| Malnutrition | 14 | 9.8 5.8–16.6ROR 9.9 · χ² 102 / p 2e-24 | 8.3 EB05 5.0 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 7.1 | no trial data cached |
| Cytopenia | 15 | 9.8 5.9–16.2ROR 9.8 · χ² 110 / p 5e-26 | 8.4 EB05 5.1 · IC025 +2.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.0 | no trial data cached |
| Pancytopenia (all blood cells low) | 69 | 9.7 7.7–12.2ROR 9.9 · χ² 528 / p 4e-117 | 9.4 EB05 7.6 · IC025 +2.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.8 · 97% clinician | no trial data cached |
| Renal tubular necrosis | 12 | 9.5 5.4–16.8ROR 9.6 · χ² 83 / p 4e-20 | 7.8 EB05 4.5 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 6.7 | no trial data cached |
| Hepatomegaly | 12 | 9.5 5.4–16.7ROR 9.5 · χ² 83 / p 5e-20 | 7.8 EB05 4.5 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 6.0 | no trial data cached |
| Haemoptysis | 33 | 9.2 6.6–12.9ROR 9.3 · χ² 234 / p 5e-53 | 8.6 EB05 6.3 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 6.6 · ♀ 23% (drug 48%) | no trial data cached |
| Hypercalcaemia | 14 | 8.9 5.3–14.9ROR 8.9 · χ² 90 / p 1e-21 | 7.4 EB05 4.5 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 6.6 | no trial data cached |
| Cholestasis (bile flow blockage) | 21 | 8.6 5.6–13.1ROR 8.6 · χ² 133 / p 4e-31 | 7.6 EB05 5.1 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 6.0 · ♀ 76% (drug 48%) · 100% clinician | no trial data cached |
| Treatment failure | 83 | 7.9 6.4–9.8ROR 8.1 · χ² 494 / p 9e-110 | 7.6 EB05 6.3 · IC025 +2.6 3/3 methods agree | Reporting / coding artifact | serious PRR 8.5 · 98% clinician | no trial data cached |
| Drug level increased | 16 | 7.5 4.6–12.3ROR 7.6 · χ² 84 / p 2e-20 | 6.4 EB05 4.1 · IC025 +1.8 3/3 methods agree | Reporting / coding artifact | serious PRR 5.1 | no trial data cached |
| Drug-induced liver injury | 29 | 7.3 5.1–10.5ROR 7.4 · χ² 153 / p 2e-35 | 6.7 EB05 4.8 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 5.0 | no trial data cached |
| Adrenal insufficiency | 11 | 7.2 4.0–12.9ROR 7.2 · χ² 52 / p 2e-13 | 5.7 EB05 3.4 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 5.0 | no trial data cached |
| Rash maculo-papular | 20 | 7.0 4.6–10.9ROR 7.1 · χ² 98 / p 2e-23 | 6.2 EB05 4.2 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 5.2 · ♀ 75% (drug 48%) | no trial data cached |
| Bone marrow failure | 18 | 6.9 4.3–10.9ROR 6.9 · χ² 84 / p 2e-20 | 6.0 EB05 4.0 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 4.8 | no trial data cached |
| Neutropenia (low neutrophils (infection-fighting cells)) | 119 | 6.9 5.7–8.2ROR 7.1 · χ² 592 / p 4e-131 | 6.7 EB05 5.7 · IC025 +2.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.9 · 97% clinician | no trial data cached |
| Drug eruption | 15 | 6.6 4.0–11.0ROR 6.7 · χ² 66 / p 2e-16 | 5.6 EB05 3.6 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 4.6 | no trial data cached |
| Chromaturia | 18 | 6.2 3.9–9.9ROR 6.3 · χ² 74 / p 5e-18 | 5.4 EB05 3.6 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 6.1 | no trial data cached |
| Osteomyelitis | 14 | 6.0 3.6–10.2ROR 6.1 · χ² 54 / p 1e-13 | 5.1 EB05 3.2 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 4.3 | no trial data cached |
| Anorexia | 10 | 6.0 3.2–11.1ROR 6.0 · χ² 37 / p 7e-10 | 4.8 EB05 2.8 · IC025 +1.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.9 | no trial data cached |
| Hepatic function abnormal | 26 | 5.5 3.7–8.0ROR 5.5 · χ² 91 / p 8e-22 | 5.0 EB05 3.6 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 3.9 · 96% clinician | no trial data cached |
| Drug ineffective for unapproved indication | 39 | 5.5 4.0–7.5ROR 5.5 · χ² 138 / p 4e-32 | 5.1 EB05 3.9 · IC025 +1.8 3/3 methods agree | Reporting / coding artifact | serious PRR 6.5 | no trial data cached |
| Hepatitis (liver inflammation) | 17 | 5.2 3.2–8.3ROR 5.2 · χ² 53 / p 1e-13 | 4.6 EB05 3.0 · IC025 +1.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.7 | no trial data cached |
| Lymphadenopathy | 23 | 5.1 3.4–7.6ROR 5.1 · χ² 71 / p 2e-17 | 4.6 EB05 3.3 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 4.6 | no trial data cached |
| Ascites | 19 | 5.0 3.2–7.9ROR 5.1 · χ² 58 / p 2e-14 | 4.5 EB05 3.1 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 3.6 | no trial data cached |
Trial evidence (ClinicalTrials.gov)
Trial cross-check not yet run for this drug (ClinicalTrials.gov pull covers the 800 most-reported drugs first).
Most frequently reported reactions
By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Drug interaction | 263 | 12.9 11.5–14.5ROR 14.2 · χ² 2,904 / p <1e-300 | 12.9 EB05 11.6 · IC025 +3.5 3/3 methods agree | Reporting / coding artifact | serious PRR 8.7 · 95% clinician | no trial data cached |
| Drug resistance | 161 | 49.2 42.3–57.2ROR 52.3 · χ² 7,513 / p <1e-300 | 48.6 EB05 42.6 · IC025 +5.2 3/3 methods agree | Reporting / coding artifact | serious PRR 31.3 · 99% clinician | no trial data cached |
| Drug intolerance | 128 | 10.4 8.8–12.3ROR 10.9 · χ² 1,080 / p 5e-237 | 10.2 EB05 8.8 · IC025 +3.0 3/3 methods agree | Reporting / coding artifact | serious PRR 5.6 · ♀ 70% (drug 48%) | no trial data cached |
| Neutropenia (low neutrophils (infection-fighting cells)) | 119 | 6.9 5.7–8.2ROR 7.1 · χ² 592 / p 4e-131 | 6.7 EB05 5.7 · IC025 +2.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.9 · 97% clinician | no trial data cached |
| Treatment failure | 83 | 7.9 6.4–9.8ROR 8.1 · χ² 494 / p 9e-110 | 7.6 EB05 6.3 · IC025 +2.6 3/3 methods agree | Reporting / coding artifact | serious PRR 8.5 · 98% clinician | no trial data cached |
| Drug reaction with eosinophilia and systemic symptoms | 82 | 25.1 20.3–31.1ROR 25.9 · χ² 1,870 / p <1e-300 | 24.9 EB05 20.7 · IC025 +4.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 17.4 · ♀ 81% (drug 48%) · 94% clinician | no trial data cached |
| Pancytopenia (all blood cells low) | 69 | 9.7 7.7–12.2ROR 9.9 · χ² 528 / p 4e-117 | 9.4 EB05 7.6 · IC025 +2.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.8 · 97% clinician | no trial data cached |
| Thrombocytopenia (low platelets) | 65 | 4.5 3.6–5.8ROR 4.6 · χ² 177 / p 1e-40 | 4.4 EB05 3.6 · IC025 +1.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.2 · ♀ 18% (drug 48%) · 98% clinician | no trial data cached |
| Leukopenia (low white blood cells) | 64 | 10.0 7.9–12.8ROR 10.2 · χ² 511 / p 2e-113 | 9.7 EB05 7.8 · IC025 +2.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.2 · 94% clinician | no trial data cached |
| Uveitis | 61 | 35.4 27.6–45.4ROR 36.2 · χ² 1,995 / p <1e-300 | 34.9 EB05 28.1 · IC025 +4.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 22.7 · 98% clinician | no trial data cached |
| Toxicity to various agents | 60 | 2.8 2.2–3.6ROR 2.8 · χ² 68 / p 1e-16 | 2.7 EB05 2.2 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 2.0 | no trial data cached |
| Electrocardiogram qt prolonged | 52 | 11.3 8.6–14.8ROR 11.5 · χ² 477 / p 5e-106 | 11.0 EB05 8.5 · IC025 +2.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 8.0 · ♀ 26% (drug 48%) · 98% clinician | no trial data cached |
| Hepatotoxicity (liver damage) | 50 | 17.6 13.4–23.2ROR 17.9 · χ² 767 / p 5e-169 | 17.5 EB05 13.7 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 12.0 · 98% clinician | no trial data cached |
| Tuberculosis | 50 | 30.4 23.1–40.1ROR 31.0 · χ² 1,389 / p <1e-300 | 30.0 EB05 23.7 · IC025 +4.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 21.1 · 90% clinician | no trial data cached |
| Neuropathy peripheral (nerve damage in hands/feet) | 48 | 4.0 3.0–5.2ROR 4.0 · χ² 104 / p 1e-24 | 3.8 EB05 3.0 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 3.2 · 96% clinician | no trial data cached |
Unlabeled candidate signals
These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.
- Nephropathy toxic — n=26, PRR 18.2
- Hepatotoxicity — n=50, PRR 17.6
- Acute hepatic failure — n=30, PRR 17.2
- Pulmonary mass — n=26, PRR 13.7
- Deafness — n=37, PRR 11.0
- Haemoptysis — n=33, PRR 9.2
- Cholestasis — n=21, PRR 8.6
- Drug-induced liver injury — n=29, PRR 7.3
- Rash maculo-papular — n=20, PRR 7.0
- Hepatic function abnormal — n=26, PRR 5.5
Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.
Common questions
What are the most reported side effects of Rifabutin?
In FDA FAERS, the most frequently co-reported reaction terms for Rifabutin are neutropenia, drug reaction with eosinophilia and systemic symptoms, pancytopenia, thrombocytopenia, leukopenia, uveitis. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.
Does Rifabutin have an FDA boxed warning?
No. The FDA label retrieved for Rifabutin has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Rifabutin causes these side effects?
No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.
Sources & methods
- FDA label via openFDA (set ID fd6062e2-17c8-48f4-a1fe-69ebe410f583, effective 20260220; matched on
openfda.generic_name.exact:"RIFABUTIN") - Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
- FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA
count=aggregation, fieldpatient.drug.openfda.generic_name.exact, 94 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction - Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
- Seriousness and sex counts from openFDA
count=serious,patient.patientsex,seriousnessdeath
Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.