Drug · FAERS side-effect profile with label screen
Clofazimine side effects: what 6,351 FDA adverse event reports show
Brand names
Lamprene
openFDA label
Who reports
6,351 reports · 89% serious · 1,259 with death outcome · 48% female
openFDA FAERS counts, all years, deduplication not applied
Used for
LAMPRENE is an antimycobacterial indicated for the treatment of lepromatous leprosy, including dapsone-resistant lepromatous leprosy and lepromatous leprosy complicated by erythema nodosum leprosum. ( 1.1 ) To prevent the development of drug-resistance, LAMPRENE should be used only as a part of combination therapy for initial treatment of lepromatous leprosy.
FDA label, Indications and Usage
What it is
LAMPRENE (clofazimine) is an antimycobacterial available as soft gelatin capsules for oral administration.
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 3Labeled (related wording) 6Reporting / coding artifact 2Lab value / disease marker 3Not in label — unassessed 26
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.
- Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
- 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. 226 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 |
|---|---|---|---|---|---|---|
| Electrocardiogram qt prolonged | 762 | 71.4 66.8–76.4ROR 81.0 · χ² 51,786 / p <1e-300 | 69.8 EB05 65.7 · IC025 +5.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 45.8 · 92% clinician | no trial data cached |
| Tuberculosis | 148 | 38.4 32.7–45.1ROR 39.3 · χ² 5,299 / p <1e-300 | 37.8 EB05 33.0 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious PRR 24.9 | no trial data cached |
| Drug resistance | 268 | 34.8 30.9–39.2ROR 36.3 · χ² 8,684 / p <1e-300 | 34.4 EB05 31.1 · IC025 +4.8 3/3 methods agree | Reporting / coding artifact | serious PRR 19.8 · 97% clinician | no trial data cached |
| Hepatotoxicity (liver damage) | 186 | 27.9 24.2–32.2ROR 28.7 · χ² 4,767 / p <1e-300 | 27.6 EB05 24.5 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious PRR 18.3 · 96% clinician | no trial data cached |
| Polyneuropathy | 75 | 20.9 16.7–26.2ROR 21.2 · χ² 1,396 / p <1e-300 | 20.7 EB05 17.1 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious PRR 13.6 · 97% clinician | no trial data cached |
| Drug-induced liver injury | 143 | 15.4 13.1–18.1ROR 15.7 · χ² 1,901 / p <1e-300 | 15.3 EB05 13.3 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious PRR 10.0 | no trial data cached |
| Drug reaction with eosinophilia and systemic symptoms | 115 | 14.9 12.4–17.9ROR 15.2 · χ² 1,475 / p <1e-300 | 14.8 EB05 12.6 · IC025 +3.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 9.6 · 96% clinician | no trial data cached |
| Electrolyte imbalance | 50 | 14.4 10.9–19.0ROR 14.5 · χ² 608 / p 1e-134 | 14.2 EB05 11.1 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious PRR 9.6 | no trial data cached |
| Incorrect product administration duration | 88 | 14.4 11.7–17.7ROR 14.6 · χ² 1,078 / p 9e-237 | 14.2 EB05 11.9 · IC025 +3.4 3/3 methods agree | Reporting / coding artifact | serious n=81 | no trial data cached |
| Haemoptysis | 116 | 13.8 11.5–16.5ROR 14.0 · χ² 1,355 / p 6e-297 | 13.6 EB05 11.6 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 9.3 | no trial data cached |
| Neuropathy peripheral (nerve damage in hands/feet) | 383 | 13.4 12.2–14.8ROR 14.2 · χ² 4,395 / p <1e-300 | 13.4 EB05 12.3 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 10.1 · 91% clinician | no trial data cached |
| Deafness | 95 | 12.0 9.8–14.7ROR 12.2 · χ² 946 / p 5e-208 | 11.8 EB05 9.9 · IC025 +3.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 8.0 | no trial data cached |
| Pneumothorax | 54 | 11.3 8.6–14.7ROR 11.4 · χ² 494 / p 8e-110 | 11.0 EB05 8.6 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 7.3 | no trial data cached |
| Nephropathy toxic | 37 | 11.0 8.0–15.2ROR 11.1 · χ² 326 / p 4e-73 | 10.5 EB05 7.8 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 7.3 | no trial data cached |
| Malnutrition | 35 | 10.4 7.5–14.5ROR 10.5 · χ² 288 / p 6e-65 | 9.9 EB05 7.2 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 7.0 | no trial data cached |
| Aspartate aminotransferase increased | 158 | 9.9 8.4–11.5ROR 10.1 · χ² 1,247 / p 2e-273 | 9.7 EB05 8.5 · IC025 +3.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 6.9 | no trial data cached |
| Transaminases increased | 66 | 9.8 7.7–12.5ROR 9.9 · χ² 514 / p 4e-114 | 9.5 EB05 7.7 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 6.7 · 97% clinician | no trial data cached |
| Blood sodium decreased | 55 | 9.7 7.4–12.6ROR 9.8 · χ² 419 / p 2e-93 | 9.3 EB05 7.3 · IC025 +2.7 3/3 methods agree | Lab value / disease marker | serious PRR 6.7 · ♀ 26% (drug 48%) | no trial data cached |
| Hypomagnesaemia | 39 | 9.3 6.8–12.7ROR 9.4 · χ² 280 / p 3e-63 | 8.7 EB05 6.6 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 6.2 | no trial data cached |
| Sputum discoloured | 26 | 9.1 6.2–13.4ROR 9.1 · χ² 179 / p 4e-41 | 8.3 EB05 5.8 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 7.4 | no trial data cached |
| Blood calcium decreased | 31 | 9.1 6.4–12.9ROR 9.1 · χ² 215 / p 6e-49 | 8.4 EB05 6.1 · IC025 +2.4 3/3 methods agree | Lab value / disease marker | serious PRR 7.3 | no trial data cached |
| Hypokalaemia (low potassium) | 121 | 8.7 7.3–10.4ROR 8.9 · χ² 819 / p 2e-180 | 8.5 EB05 7.3 · IC025 +2.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.7 | no trial data cached |
| Myelosuppression | 87 | 8.5 6.9–10.4ROR 8.6 · χ² 565 / p 4e-125 | 8.2 EB05 6.8 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 5.5 · 95% clinician | no trial data cached |
| Skin discolouration | 117 | 8.4 7.0–10.1ROR 8.6 · χ² 758 / p 4e-167 | 8.2 EB05 7.0 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 7.2 · ♀ 73% (drug 48%) · 91% clinician | no trial data cached |
| Anaemia (low red blood cells) | 474 | 8.2 7.5–9.0ROR 8.8 · χ² 3,018 / p <1e-300 | 8.2 EB05 7.6 · IC025 +2.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.6 | no trial data cached |
| Gastroenteritis | 36 | 8.2 5.9–11.3ROR 8.2 · χ² 219 / p 7e-50 | 7.6 EB05 5.7 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 5.6 | no trial data cached |
| Oral candidiasis (oral thrush) | 32 | 8.1 5.8–11.5ROR 8.2 · χ² 193 / p 4e-44 | 7.5 EB05 5.5 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 7.3 | no trial data cached |
| Alanine aminotransferase increased | 151 | 8.1 6.9–9.5ROR 8.3 · χ² 938 / p 3e-206 | 8.0 EB05 7.0 · IC025 +2.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.6 | no trial data cached |
| Hepatitis (liver inflammation) | 61 | 7.9 6.1–10.1ROR 8.0 · χ² 359 / p 2e-80 | 7.5 EB05 6.0 · IC025 +2.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.2 · 97% clinician | no trial data cached |
| Respiratory failure | 173 | 7.8 6.8–9.1ROR 8.0 · χ² 1,027 / p 1e-225 | 7.7 EB05 6.8 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 5.1 | no trial data cached |
| Tinnitus (ringing in the ears) | 104 | 7.5 6.2–9.0ROR 7.6 · χ² 577 / p 9e-128 | 7.3 EB05 6.2 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 6.4 | no trial data cached |
| Clostridium difficile colitis | 24 | 7.5 5.0–11.2ROR 7.5 · χ² 128 / p 6e-30 | 6.7 EB05 4.7 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 4.9 · ♀ 19% (drug 48%) · 100% clinician | no trial data cached |
| Lymphopenia | 30 | 7.1 4.9–10.1ROR 7.1 · χ² 150 / p 1e-34 | 6.4 EB05 4.7 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 4.9 · ♀ 0% (drug 48%) · 93% clinician | no trial data cached |
| Platelet count increased | 26 | 6.6 4.5–9.7ROR 6.6 · χ² 117 / p 1e-27 | 6.0 EB05 4.2 · IC025 +1.9 3/3 methods agree | Lab value / disease marker | serious PRR 5.6 | no trial data cached |
| Toxic skin eruption | 20 | 6.5 4.2–10.1ROR 6.6 · χ² 88 / p 3e-21 | 5.8 EB05 3.9 · IC025 +1.8 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.2 · ♀ 15% (drug 48%) · 100% clinician | no trial data cached |
| Hepatocellular injury | 28 | 6.5 4.5–9.4ROR 6.5 · χ² 125 / p 3e-29 | 5.9 EB05 4.3 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 4.2 · 100% clinician | no trial data cached |
| Hyperbilirubinaemia | 20 | 6.4 4.1–9.9ROR 6.4 · χ² 86 / p 9e-21 | 5.7 EB05 3.9 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 4.2 | no trial data cached |
| Psychotic disorder | 57 | 6.4 4.9–8.3ROR 6.4 · χ² 253 / p 3e-57 | 6.1 EB05 4.9 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 4.5 | no trial data cached |
| Productive cough (cough with phlegm) | 87 | 6.1 4.9–7.5ROR 6.1 · χ² 364 / p 2e-81 | 5.9 EB05 4.9 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 5.0 | no trial data cached |
| Hypothyroidism | 58 | 6.0 4.7–7.8ROR 6.1 · χ² 238 / p 6e-54 | 5.8 EB05 4.6 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 4.3 | 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 |
|---|---|---|---|---|---|---|
| Electrocardiogram qt prolonged | 762 | 71.4 66.8–76.4ROR 81.0 · χ² 51,786 / p <1e-300 | 69.8 EB05 65.7 · IC025 +5.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 45.8 · 92% clinician | no trial data cached |
| Off label use (used outside approved label) | 704 | 2.7 2.5–2.9ROR 2.9 · χ² 771 / p 6e-170 | 2.7 EB05 2.5 · IC025 +1.3 3/3 methods agree | Reporting / coding artifact | serious PRR 3.0 | no trial data cached |
| Nausea | 563 | 2.4 2.2–2.6ROR 2.5 · χ² 455 / p 2e-101 | 2.4 EB05 2.2 · IC025 +1.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.6 | no trial data cached |
| Vomiting | 503 | 3.5 3.3–3.9ROR 3.8 · χ² 936 / p 6e-206 | 3.5 EB05 3.3 · IC025 +1.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.2 | no trial data cached |
| Anaemia (low red blood cells) | 474 | 8.2 7.5–9.0ROR 8.8 · χ² 3,018 / p <1e-300 | 8.2 EB05 7.6 · IC025 +2.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.6 | no trial data cached |
| Dyspnoea (shortness of breath) | 403 | 2.4 2.1–2.6ROR 2.4 · χ² 321 / p 5e-72 | 2.3 EB05 2.2 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 2.0 | no trial data cached |
| Neuropathy peripheral (nerve damage in hands/feet) | 383 | 13.4 12.2–14.8ROR 14.2 · χ² 4,395 / p <1e-300 | 13.4 EB05 12.3 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 10.1 · 91% clinician | no trial data cached |
| Product use in unapproved indication | 284 | 3.8 3.4–4.3ROR 4.0 · χ² 600 / p 7e-133 | 3.8 EB05 3.5 · IC025 +1.7 3/3 methods agree | Reporting / coding artifact | serious PRR 4.1 | no trial data cached |
| Cough | 276 | 3.3 2.9–3.7ROR 3.4 · χ² 435 / p 6e-97 | 3.2 EB05 2.9 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 3.3 | no trial data cached |
| Drug resistance | 268 | 34.8 30.9–39.2ROR 36.3 · χ² 8,684 / p <1e-300 | 34.4 EB05 31.1 · IC025 +4.8 3/3 methods agree | Reporting / coding artifact | serious PRR 19.8 · 97% clinician | no trial data cached |
| Pyrexia (fever) | 229 | 2.2 1.9–2.5ROR 2.2 · χ² 148 / p 2e-34 | 2.2 EB05 2.0 · IC025 +0.9 | Labeled (related wording) related wording | serious PRR 1.7 | no trial data cached |
| Decreased appetite (loss of appetite) | 223 | 3.2 2.8–3.6ROR 3.3 · χ² 335 / p 5e-75 | 3.2 EB05 2.8 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 3.0 | no trial data cached |
| Death | 221 | 0.8 0.7–1.0ROR 0.8 · χ² 6 / p 0.006 | 0.8 EB05 0.8 · IC025 -0.5 PRR-only: not supported by EBGM or IC | Outcome field, not a reaction | serious PRR 0.5 | no trial data cached |
| Asthenia (weakness) | 211 | 1.9 1.6–2.1ROR 1.9 · χ² 83 / p 3e-20 | 1.8 EB05 1.6 · IC025 +0.7 | Not in label — unassessed | serious PRR 1.6 | no trial data cached |
| Hepatotoxicity (liver damage) | 186 | 27.9 24.2–32.2ROR 28.7 · χ² 4,767 / p <1e-300 | 27.6 EB05 24.5 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious PRR 18.3 · 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.
- Tuberculosis — n=148, PRR 38.4
- Hepatotoxicity — n=186, PRR 27.9
- Polyneuropathy — n=75, PRR 20.9
- Drug-induced liver injury — n=143, PRR 15.4
- Electrolyte imbalance — n=50, PRR 14.4
- Haemoptysis — n=116, PRR 13.8
- Neuropathy peripheral — n=383, PRR 13.4
- Pneumothorax — n=54, PRR 11.3
- Nephropathy toxic — n=37, PRR 11.0
- Malnutrition — n=35, PRR 10.4
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 Clofazimine?
In FDA FAERS, the most frequently co-reported reaction terms for Clofazimine are electrocardiogram qt prolonged, nausea, vomiting, anaemia, dyspnoea, neuropathy peripheral. 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 Clofazimine have an FDA boxed warning?
No. The FDA label retrieved for Clofazimine has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Clofazimine 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 2e07448f-f888-4747-80ab-570c1b621250, effective 20260817; matched on
openfda.generic_name.exact:"CLOFAZIMINE") - 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, 266 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.