Drug · FAERS side-effect profile with label screen
Rifampicin side effects: what 10,058 FDA adverse event reports show
Drug class
Not stated in label
Brand names
Rifadin
openFDA label
Who reports
10,058 reports · 97% serious · 1,593 with death outcome · 45% female
openFDA FAERS counts, all years, deduplication not applied
Used for
3. How Rifadin Infusion is given Rifadin Infusion is given by a doctor or nurse. This is because it needs to be given as a slow drip into a vein (infusion). How much is given If you are not sure why you are being given Rifadin Infusion or have any questions about how much Rifadin Infusion is being given to you, speak to your doctor or nurse.
FDA label, Indications and Usage
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 1Labeled (related wording) 6Likely indication confounding 11Not 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.
- Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
- 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. 989 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 |
|---|---|---|---|---|---|---|
| Serpiginous choroiditis | 19 | 1,347.3 755.7–2,401.8ROR 1,349.8 · χ² 14,639 / p <1e-300 | 446.6 EB05 302.2 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious n=19 | no trial data cached |
| Mycobacterium ulcerans infection | 22 | 1,292.6 758.6–2,202.4ROR 1,295.4 · χ² 16,649 / p <1e-300 | 468.8 EB05 326.4 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious n=22 · 100% clinician | no trial data cached |
| Tuberculoma of central nervous system | 53 | 851.5 618.6–1,172.0ROR 856.0 · χ² 31,239 / p <1e-300 | 494.4 EB05 392.4 · IC025 +6.1 3/3 methods agree | Labeled (related wording) related wording | serious n=53 · 100% clinician | no trial data cached |
| Type 2 lepra reaction | 35 | 476.6 330.2–688.1ROR 478.3 · χ² 13,103 / p <1e-300 | 319.5 EB05 240.1 · IC025 +5.3 3/3 methods agree | Not in label — unassessed | serious n=35 · ♀ 22% (drug 45%) · 100% clinician | no trial data cached |
| Pulmonary interstitial emphysema syndrome | 22 | 380.2 241.3–598.9ROR 381.0 · χ² 6,705 / p <1e-300 | 251.1 EB05 174.8 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious n=22 · ♀ 0% (drug 45%) · 91% clinician | no trial data cached |
| Tuberculoid leprosy | 10 | 373.9 190.6–733.2ROR 374.3 · χ² 2,839 / p <1e-300 | 197.7 EB05 114.8 · IC025 +3.2 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=10 | no trial data cached |
| Diaphragmatic injury | 11 | 364.8 192.2–692.6ROR 365.2 · χ² 3,088 / p <1e-300 | 201.9 EB05 120.3 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Immune reconstitution inflammatory syndrome associated tuberculosis | 46 | 334.2 244.9–456.2ROR 335.8 · χ² 12,862 / p <1e-300 | 257.0 EB05 200.5 · IC025 +5.6 3/3 methods agree | Labeled (related wording) related wording | serious n=46 · 95% clinician | no trial data cached |
| Alveolar lung disease | 22 | 270.9 173.7–422.4ROR 271.5 · χ² 4,991 / p <1e-300 | 198.4 EB05 138.1 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious n=22 · ♀ 0% (drug 45%) · 91% clinician | no trial data cached |
| Tuberculosis of central nervous system | 29 | 254.8 173.3–374.7ROR 255.6 · χ² 6,300 / p <1e-300 | 197.5 EB05 144.2 · IC025 +4.9 3/3 methods agree | Labeled (related wording) related wording | serious n=29 · ♀ 65% (drug 45%) | no trial data cached |
| Hypoprothrombinaemia | 31 | 237.9 164.1–344.8ROR 238.6 · χ² 6,343 / p <1e-300 | 188.7 EB05 139.2 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious n=31 · ♀ 13% (drug 45%) · 100% clinician | no trial data cached |
| Acid fast bacilli infection | 14 | 202.7 117.1–350.9ROR 203.0 · χ² 2,378 / p <1e-300 | 147.8 EB05 93.6 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious n=14 | no trial data cached |
| Meningitis tuberculous | 49 | 198.7 148.3–266.3ROR 199.7 · χ² 8,612 / p <1e-300 | 169.4 EB05 133.2 · IC025 +5.5 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=49 · 95% clinician | no trial data cached |
| Immune reconstitution syndrome | 109 | 189.6 156.0–230.5ROR 191.7 · χ² 18,554 / p <1e-300 | 168.6 EB05 143.7 · IC025 +6.3 3/3 methods agree | Not in label — unassessed | serious n=108 | no trial data cached |
| Paradoxical drug reaction | 296 | 182.9 162.7–205.7ROR 188.4 · χ² 49,015 / p <1e-300 | 166.3 EB05 151.0 · IC025 +6.8 3/3 methods agree | Labeled adverse reaction exact term | serious n=295 · 98% clinician | no trial data cached |
| Sideroblastic anaemia | 10 | 158.2 83.2–300.9ROR 158.3 · χ² 1,308 / p 1e-286 | 115.3 EB05 66.9 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Choroiditis | 25 | 148.6 99.1–222.9ROR 148.9 · χ² 3,281 / p <1e-300 | 125.6 EB05 89.4 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious n=25 · 100% clinician | no trial data cached |
| Rhodococcus infection | 11 | 146.9 79.7–270.7ROR 147.0 · χ² 1,354 / p 8e-297 | 111.2 EB05 66.3 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Vitamin k deficiency | 24 | 133.7 88.5–202.0ROR 134.1 · χ² 2,846 / p <1e-300 | 114.4 EB05 80.9 · IC025 +4.5 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=24 | no trial data cached |
| Tuberculosis gastrointestinal | 19 | 132.9 83.6–211.3ROR 133.1 · χ² 2,214 / p <1e-300 | 111.2 EB05 75.3 · IC025 +4.1 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=19 | no trial data cached |
| Cardiac valve vegetation | 26 | 119.1 80.2–176.7ROR 119.4 · χ² 2,767 / p <1e-300 | 104.2 EB05 74.7 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious n=26 · ♀ 22% (drug 45%) · 92% clinician | no trial data cached |
| Peritoneal tuberculosis | 23 | 116.2 76.4–176.8ROR 116.5 · χ² 2,379 / p <1e-300 | 101.0 EB05 70.9 · IC025 +4.4 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=23 · 100% clinician | no trial data cached |
| Leprosy | 11 | 115.4 62.9–211.8ROR 115.5 · χ² 1,075 / p 4e-236 | 92.3 EB05 55.0 · IC025 +3.2 3/3 methods agree | Likely indication confounding term in indications | serious n=11 | no trial data cached |
| Bone tuberculosis | 19 | 108.8 68.6–172.6ROR 109.0 · χ² 1,827 / p <1e-300 | 93.9 EB05 63.5 · IC025 +4.1 3/3 methods agree | Labeled (related wording) related wording | serious n=19 | no trial data cached |
| Tuberculous pleurisy | 21 | 96.2 62.1–148.9ROR 96.4 · χ² 1,800 / p <1e-300 | 85.0 EB05 58.7 · IC025 +4.2 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=21 | no trial data cached |
| Lymph node tuberculosis | 32 | 93.7 65.8–133.5ROR 94.0 · χ² 2,720 / p <1e-300 | 85.3 EB05 63.2 · IC025 +4.7 3/3 methods agree | Labeled (related wording) related wording | serious n=33 | no trial data cached |
| Tubo-ovarian abscess | 10 | 88.3 46.9–166.2ROR 88.3 · χ² 746 / p 2e-164 | 73.3 EB05 42.5 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Extrapulmonary tuberculosis | 12 | 87.8 49.3–156.4ROR 87.9 · χ² 906 / p 2e-199 | 74.6 EB05 45.5 · IC025 +3.3 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=12 | no trial data cached |
| Meconium in amniotic fluid | 14 | 87.2 51.1–148.9ROR 87.4 · χ² 1,064 / p 1e-233 | 75.4 EB05 47.8 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious n=14 | no trial data cached |
| Endocarditis staphylococcal | 19 | 84.4 53.4–133.5ROR 84.5 · χ² 1,425 / p <1e-300 | 75.2 EB05 50.9 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious n=19 | no trial data cached |
| Antimicrobial susceptibility test resistant | 12 | 83.4 46.8–148.4ROR 83.5 · χ² 861 / p 2e-189 | 71.4 EB05 43.5 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Granulomatous liver disease | 26 | 79.9 54.0–118.2ROR 80.1 · χ² 1,875 / p <1e-300 | 73.0 EB05 52.3 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious n=26 | no trial data cached |
| Disseminated tuberculosis | 86 | 72.9 58.8–90.3ROR 73.5 · χ² 5,818 / p <1e-300 | 69.4 EB05 57.9 · IC025 +5.3 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=85 · 91% clinician | no trial data cached |
| Pulmonary tuberculosis | 142 | 71.8 60.8–84.8ROR 72.8 · χ² 9,510 / p <1e-300 | 68.8 EB05 59.8 · IC025 +5.5 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=142 | no trial data cached |
| Biopsy liver abnormal | 10 | 71.6 38.2–134.6ROR 71.7 · χ² 607 / p 3e-134 | 61.5 EB05 35.7 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Bovine tuberculosis | 12 | 67.1 37.7–119.1ROR 67.1 · χ² 694 / p 4e-153 | 59.2 EB05 36.1 · IC025 +3.2 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=12 | no trial data cached |
| Drug rash with eosinophilia and systemic symptoms | 96 | 62.6 51.2–76.7ROR 63.2 · χ² 5,591 / p <1e-300 | 60.1 EB05 50.7 · IC025 +5.2 3/3 methods agree | Labeled (related wording) related wording | serious n=96 · 91% clinician | no trial data cached |
| Jarisch-herxheimer reaction | 20 | 60.0 38.5–93.6ROR 60.2 · χ² 1,072 / p 3e-235 | 55.4 EB05 37.9 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious n=19 | no trial data cached |
| Mycobacterial infection | 48 | 59.7 44.9–79.6ROR 60.0 · χ² 2,638 / p <1e-300 | 56.8 EB05 44.6 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious n=48 · 96% clinician | no trial data cached |
| Red man syndrome | 24 | 57.7 38.4–86.5ROR 57.8 · χ² 1,245 / p 5e-273 | 53.8 EB05 38.1 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious n=24 · ♀ 22% (drug 45%) | 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 | 1,005 | 13.3 12.5–14.1ROR 14.6 · χ² 11,417 / p <1e-300 | 13.2 EB05 12.5 · IC025 +3.6 3/3 methods agree | Reporting / coding artifact | serious PRR 8.4 · 95% clinician | no trial data cached |
| Pyrexia (fever) | 917 | 5.5 5.2–5.9ROR 6.0 · χ² 3,450 / p <1e-300 | 5.5 EB05 5.2 · IC025 +2.4 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.1 · 92% clinician | no trial data cached |
| Drug reaction with eosinophilia and systemic symptoms | 558 | 46.5 42.9–50.5ROR 49.2 · χ² 24,296 / p <1e-300 | 45.5 EB05 42.4 · IC025 +5.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 26.8 · 98% clinician | no trial data cached |
| Drug ineffective (drug did not work) | 517 | 0.8 0.8–0.9ROR 0.8 · χ² 22 / p 1e-6 | 0.8 EB05 0.8 · IC025 -0.4 PRR-only: not supported by EBGM or IC | Reporting / coding artifact | serious PRR 1.3 · 92% clinician | no trial data cached |
| Vomiting | 452 | 2.0 1.8–2.2ROR 2.1 · χ² 234 / p 5e-53 | 2.0 EB05 1.9 · IC025 +0.9 | Likely indication confounding term in indications; also in warnings | serious PRR 1.7 · 93% clinician | no trial data cached |
| Drug-induced liver injury | 443 | 30.4 27.7–33.3ROR 31.7 · χ² 12,388 / p <1e-300 | 29.9 EB05 27.6 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious PRR 17.9 · 98% clinician | no trial data cached |
| Nausea | 393 | 1.0 0.9–1.1ROR 1.0 · χ² 1 / p 0.230 | 1.0 EB05 1.0 · IC025 -0.1 PRR-only: not supported by EBGM or IC | Likely indication confounding term in indications; also in warnings | serious PRR 1.1 | no trial data cached |
| Acute kidney injury (sudden kidney damage) | 362 | 5.0 4.5–5.5ROR 5.1 · χ² 1,148 / p 7e-252 | 4.9 EB05 4.5 · IC025 +2.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 2.9 · 94% clinician | no trial data cached |
| Jaundice (yellowing of skin/eyes) | 361 | 28.3 25.5–31.3ROR 29.3 · χ² 9,348 / p <1e-300 | 27.9 EB05 25.5 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious PRR 17.3 · 95% clinician | no trial data cached |
| Condition aggravated | 345 | 2.4 2.1–2.6ROR 2.4 · χ² 279 / p 5e-63 | 2.4 EB05 2.2 · IC025 +1.1 3/3 methods agree | Reporting / coding artifact | serious PRR 2.1 · 94% clinician | no trial data cached |
| Thrombocytopenia (low platelets) | 309 | 5.8 5.2–6.5ROR 5.9 · χ² 1,223 / p 3e-268 | 5.7 EB05 5.2 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 3.5 · 93% clinician | no trial data cached |
| Rash | 302 | 1.5 1.3–1.6ROR 1.5 · χ² 43 / p 3e-11 | 1.5 EB05 1.3 · IC025 +0.3 | Labeled adverse reaction exact term | serious PRR 1.8 · 94% clinician | no trial data cached |
| Paradoxical drug reaction | 296 | 182.9 162.7–205.7ROR 188.4 · χ² 49,015 / p <1e-300 | 166.3 EB05 151.0 · IC025 +6.8 3/3 methods agree | Labeled adverse reaction exact term | serious n=295 · 98% clinician | no trial data cached |
| Eosinophilia | 286 | 34.7 30.9–38.9ROR 35.7 · χ² 9,175 / p <1e-300 | 34.1 EB05 30.9 · IC025 +4.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 21.0 · 96% clinician | no trial data cached |
| Drug resistance | 268 | 22.0 19.5–24.7ROR 22.5 · χ² 5,294 / p <1e-300 | 21.7 EB05 19.6 · IC025 +4.2 3/3 methods agree | Reporting / coding artifact | serious PRR 14.5 · 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.
- Mycobacterium ulcerans infection — n=22, PRR 1,292.6
- Type 2 lepra reaction — n=35, PRR 476.6
- Pulmonary interstitial emphysema syndrome — n=22, PRR 380.2
- Alveolar lung disease — n=22, PRR 270.9
- Hypoprothrombinaemia — n=31, PRR 237.9
- Immune reconstitution syndrome — n=109, PRR 189.6
- Choroiditis — n=25, PRR 148.6
- Cardiac valve vegetation — n=26, PRR 119.1
- Granulomatous liver disease — n=26, PRR 79.9
- Jarisch-herxheimer reaction — n=20, PRR 60.0
✓ A hand-written Bradford Hill causality assessment exists for this drug: Rifampicin ↔ Drug-induced liver injury.
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 Rifampicin?
In FDA FAERS, the most frequently co-reported reaction terms for Rifampicin are pyrexia, drug reaction with eosinophilia and systemic symptoms, vomiting, drug-induced liver injury, nausea, acute kidney injury. 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 Rifampicin have an FDA boxed warning?
No. The FDA label retrieved for Rifampicin has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Rifampicin 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 1b074c23-dd35-43c9-820c-0e603481fdd3, effective 20260825; matched on
openfda.generic_name.exact:"RIFAMPICIN") - 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, 1,029 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.