Drug · FAERS side-effect profile with label screen
Dapsone side effects: what 10,611 FDA adverse event reports show
Drug class
Sulfone
FDA label (Established Pharmacologic Class)
Who reports
10,611 reports · 76% serious · 926 with death outcome · 54% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Dapsone Gel, 5%, is indicated for the topical treatment of acne vulgaris. Dapsone Gel is indicated for the topical treatment of acne vulgaris ( 1 ).
FDA label, Indications and Usage
What it is
Dapsone Gel, 5%, contains dapsone, a sulfone, in an aqueous gel base for topical dermatologic use. Dapsone gel, 5% is a gritty translucent material with visible drug substance particles.
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 2Reporting / coding artifact 1Lab value / disease marker 3Not in label — unassessed 34
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.
- 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. 1,065 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 |
|---|---|---|---|---|---|---|
| Type 1 lepra reaction | 17 | 974.4 544.5–1,743.6ROR 975.9 · χ² 10,381 / p <1e-300 | 375.0 EB05 248.0 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious n=16 | no trial data cached |
| Type 2 lepra reaction | 49 | 697.0 503.2–965.3ROR 700.2 · χ² 24,573 / p <1e-300 | 427.6 EB05 336.2 · IC025 +5.9 3/3 methods agree | Not in label — unassessed | serious n=48 · ♀ 20% (drug 54%) · 100% clinician | no trial data cached |
| Methaemoglobinaemia | 480 | 522.3 473.1–576.6ROR 547.0 · χ² 196,561 / p <1e-300 | 405.4 EB05 375.9 · IC025 +8.0 3/3 methods agree | Not in label — unassessed | serious n=465 · 96% clinician | no trial data cached |
| Lepromatous leprosy | 15 | 449.7 256.6–788.2ROR 450.3 · χ² 5,098 / p <1e-300 | 249.6 EB05 160.5 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious n=15 | no trial data cached |
| Blood methaemoglobin present | 20 | 433.1 266.9–702.8ROR 433.9 · χ² 6,704 / p <1e-300 | 264.9 EB05 181.0 · IC025 +4.5 3/3 methods agree | Lab value / disease marker | serious n=18 | no trial data cached |
| Aeromonas infection | 12 | 145.2 80.8–261.0ROR 145.4 · χ² 1,468 / p <1e-300 | 111.7 EB05 68.1 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious n=12 | no trial data cached |
| Alopecia scarring | 10 | 124.9 65.9–236.7ROR 125.0 · χ² 1,042 / p 8e-229 | 96.4 EB05 56.0 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious n=9 | no trial data cached |
| Dermatitis herpetiformis | 14 | 120.7 70.4–207.0ROR 120.9 · χ² 1,454 / p <1e-300 | 98.8 EB05 62.5 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious n=8 | no trial data cached |
| Leukaemoid reaction | 11 | 87.9 48.0–160.7ROR 87.9 · χ² 823 / p 3e-181 | 73.8 EB05 44.0 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Linear iga disease | 62 | 76.4 59.3–98.4ROR 76.9 · χ² 4,369 / p <1e-300 | 72.0 EB05 58.2 · IC025 +5.1 3/3 methods agree | Not in label — unassessed | serious n=61 · ♀ 81% (drug 54%) · 97% clinician | no trial data cached |
| Zygomycosis | 14 | 60.1 35.3–102.2ROR 60.2 · χ² 733 / p 1e-161 | 54.3 EB05 34.4 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious n=14 | no trial data cached |
| Pleocytosis | 15 | 52.5 31.4–87.6ROR 52.6 · χ² 688 / p 5e-152 | 48.2 EB05 31.0 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious n=15 | no trial data cached |
| Vanishing bile duct syndrome | 28 | 51.1 35.1–74.3ROR 51.2 · χ² 1,292 / p 4e-283 | 48.3 EB05 35.1 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious n=28 · ♀ 0% (drug 54%) · 100% clinician | no trial data cached |
| Antineutrophil cytoplasmic antibody positive | 17 | 47.2 29.2–76.3ROR 47.3 · χ² 706 / p 7e-156 | 44.0 EB05 29.1 · IC025 +3.5 3/3 methods agree | Lab value / disease marker | serious n=17 | no trial data cached |
| Chronic spontaneous urticaria | 25 | 45.8 30.8–68.1ROR 45.9 · χ² 1,028 / p 8e-226 | 43.4 EB05 30.9 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious n=21 · ♀ 100% (drug 54%) · 100% clinician | no trial data cached |
| Haemolytic anaemia | 165 | 36.9 31.7–43.0ROR 37.5 · χ² 5,626 / p <1e-300 | 36.1 EB05 31.7 · IC025 +4.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 27.0 · 93% clinician | no trial data cached |
| Disseminated cryptococcosis | 13 | 35.5 20.5–61.5ROR 35.6 · χ² 395 / p 3e-88 | 33.4 EB05 20.7 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious n=13 | no trial data cached |
| Immune reconstitution syndrome | 23 | 35.3 23.4–53.4ROR 35.4 · χ² 721 / p 5e-159 | 33.9 EB05 23.8 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious n=21 · ♀ 17% (drug 54%) | no trial data cached |
| Pyoderma gangrenosum | 53 | 29.8 22.7–39.0ROR 29.9 · χ² 1,424 / p <1e-300 | 29.1 EB05 23.1 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious n=53 | no trial data cached |
| Nocardiosis | 38 | 29.7 21.6–40.9ROR 29.8 · χ² 1,011 / p 3e-222 | 28.9 EB05 22.0 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious n=38 · ♀ 17% (drug 54%) · 100% clinician | no trial data cached |
| Steroid dependence | 12 | 28.3 16.0–50.0ROR 28.3 · χ² 285 / p 3e-64 | 26.8 EB05 16.2 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious n=12 | no trial data cached |
| Drug reaction with eosinophilia and systemic symptoms | 354 | 27.7 25.0–30.8ROR 28.7 · χ² 8,983 / p <1e-300 | 27.3 EB05 25.0 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious PRR 20.8 · 99% clinician | no trial data cached |
| Toxoplasmosis | 15 | 27.7 16.7–46.2ROR 27.8 · χ² 355 / p 2e-79 | 26.5 EB05 17.0 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious n=15 | no trial data cached |
| Pneumonia pseudomonal | 21 | 27.7 18.0–42.5ROR 27.7 · χ² 506 / p 2e-112 | 26.7 EB05 18.4 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious n=21 · 100% clinician | no trial data cached |
| Central obesity | 10 | 27.3 14.6–51.0ROR 27.4 · χ² 225 / p 4e-51 | 25.6 EB05 14.6 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Product delivery mechanism issue | 58 | 23.8 18.4–30.9ROR 24.0 · χ² 1,231 / p 5e-270 | 23.4 EB05 18.8 · IC025 +3.9 3/3 methods agree | Reporting / coding artifact | 74% consumer | no trial data cached |
| Cushingoid | 38 | 23.5 17.1–32.4ROR 23.6 · χ² 787 / p 2e-173 | 23.0 EB05 17.5 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious n=36 · 100% clinician | no trial data cached |
| Mycobacterium avium complex infection | 31 | 23.3 16.3–33.1ROR 23.3 · χ² 631 / p 1e-139 | 22.7 EB05 16.8 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious n=30 · ♀ 21% (drug 54%) · 93% clinician | no trial data cached |
| Lupus nephritis | 20 | 21.7 14.0–33.7ROR 21.8 · χ² 371 / p 6e-83 | 21.1 EB05 14.3 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious n=20 · 100% clinician | no trial data cached |
| Brain abscess | 25 | 19.7 13.3–29.2ROR 19.8 · χ² 422 / p 5e-94 | 19.2 EB05 13.6 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=25 · ♀ 0% (drug 54%) · 92% clinician | no trial data cached |
| Haemolysis | 75 | 19.3 15.4–24.2ROR 19.5 · χ² 1,273 / p 4e-279 | 19.1 EB05 15.7 · IC025 +3.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 15.0 · 97% clinician | no trial data cached |
| Lymphadenitis | 23 | 19.0 12.6–28.6ROR 19.0 · χ² 370 / p 9e-83 | 18.5 EB05 12.8 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious n=23 · 100% clinician | no trial data cached |
| Acute febrile neutrophilic dermatosis | 22 | 19.0 12.5–28.8ROR 19.0 · χ² 353 / p 4e-79 | 18.4 EB05 12.7 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious n=22 | no trial data cached |
| Bone demineralisation | 10 | 18.8 10.1–35.0ROR 18.8 · χ² 150 / p 1e-34 | 17.3 EB05 9.0 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious n=9 | no trial data cached |
| Cytomegalovirus test positive | 16 | 18.0 11.0–29.4ROR 18.0 · χ² 238 / p 5e-54 | 17.2 EB05 10.8 · IC025 +2.7 3/3 methods agree | Lab value / disease marker | serious n=15 | no trial data cached |
| Infection reactivation | 10 | 17.4 9.3–32.4ROR 17.4 · χ² 137 / p 5e-32 | 15.8 EB05 8.0 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Necrotising fasciitis | 30 | 17.0 11.8–24.3ROR 17.0 · χ² 431 / p 4e-96 | 16.6 EB05 12.0 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious n=29 · 100% clinician | no trial data cached |
| Pemphigoid | 62 | 16.7 13.0–21.4ROR 16.8 · χ² 890 / p 8e-196 | 16.4 EB05 13.2 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 12.4 | no trial data cached |
| Cytomegalovirus viraemia | 35 | 15.9 11.4–22.2ROR 16.0 · χ² 471 / p 1e-104 | 15.6 EB05 11.6 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious n=34 · ♀ 19% (drug 54%) | no trial data cached |
| Cutaneous lupus erythematosus | 15 | 15.2 9.2–25.3ROR 15.2 · χ² 184 / p 3e-42 | 14.2 EB05 8.5 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious n=15 | 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 |
|---|---|---|---|---|---|---|
| Off label use (used outside approved label) | 1,250 | 2.8 2.7–3.0ROR 3.1 · χ² 1,560 / p <1e-300 | 2.8 EB05 2.7 · IC025 +1.4 3/3 methods agree | Reporting / coding artifact | serious PRR 3.3 | no trial data cached |
| Drug ineffective (drug did not work) | 1,140 | 1.7 1.6–1.8ROR 1.8 · χ² 359 / p 3e-80 | 1.7 EB05 1.6 · IC025 +0.7 | Reporting / coding artifact | serious PRR 2.7 | no trial data cached |
| Nausea | 487 | 1.2 1.1–1.3ROR 1.2 · χ² 20 / p 4e-6 | 1.2 EB05 1.1 · IC025 +0.1 | Not in label — unassessed | serious PRR 1.3 | no trial data cached |
| Methaemoglobinaemia | 480 | 522.3 473.1–576.6ROR 547.0 · χ² 196,561 / p <1e-300 | 405.4 EB05 375.9 · IC025 +8.0 3/3 methods agree | Not in label — unassessed | serious n=465 · 96% clinician | no trial data cached |
| Fatigue (tiredness) | 475 | 1.2 1.1–1.3ROR 1.2 · χ² 17 / p 1e-5 | 1.2 EB05 1.1 · IC025 +0.1 | Not in label — unassessed | serious PRR 1.3 | no trial data cached |
| Pyrexia (fever) | 468 | 2.7 2.4–2.9ROR 2.8 · χ² 496 / p 4e-110 | 2.7 EB05 2.5 · IC025 +1.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.4 | no trial data cached |
| Diarrhoea (diarrhea) | 423 | 1.3 1.2–1.4ROR 1.3 · χ² 30 / p 2e-8 | 1.3 EB05 1.2 · IC025 +0.2 | Not in label — unassessed | serious PRR 1.3 | no trial data cached |
| Rash | 397 | 1.8 1.6–2.0ROR 1.8 · χ² 146 / p 7e-34 | 1.8 EB05 1.7 · IC025 +0.7 | Labeled adverse reaction exact term | serious PRR 2.0 | no trial data cached |
| Dyspnoea (shortness of breath) | 385 | 1.3 1.2–1.5ROR 1.4 · χ² 35 / p 2e-9 | 1.3 EB05 1.2 · IC025 +0.3 | Not in label — unassessed | serious PRR 1.3 | no trial data cached |
| Pneumonia (lung infection) | 384 | 2.3 2.1–2.6ROR 2.4 · χ² 300 / p 1e-67 | 2.3 EB05 2.2 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 1.8 | no trial data cached |
| Pain | 373 | 1.2 1.1–1.3ROR 1.2 · χ² 12 / p 2e-4 | 1.2 EB05 1.1 · IC025 +0.1 | Labeled adverse reaction exact term | serious PRR 1.2 | no trial data cached |
| Anaemia (low red blood cells) | 362 | 3.8 3.4–4.2ROR 3.9 · χ² 734 / p 8e-162 | 3.7 EB05 3.4 · IC025 +1.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.0 | no trial data cached |
| Condition aggravated | 359 | 2.4 2.1–2.6ROR 2.4 · χ² 281 / p 2e-63 | 2.3 EB05 2.1 · IC025 +1.1 3/3 methods agree | Reporting / coding artifact | serious PRR 2.4 | no trial data cached |
| Drug reaction with eosinophilia and systemic symptoms | 354 | 27.7 25.0–30.8ROR 28.7 · χ² 8,983 / p <1e-300 | 27.3 EB05 25.0 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious PRR 20.8 · 99% clinician | no trial data cached |
| Treatment failure | 349 | 8.4 7.6–9.4ROR 8.7 · χ² 2,278 / p <1e-300 | 8.3 EB05 7.6 · IC025 +2.9 3/3 methods agree | Reporting / coding artifact | serious PRR 11.1 · ♀ 75% (drug 54%) | 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.
- Type 2 lepra reaction — n=49, PRR 697.0
- Methaemoglobinaemia — n=480, PRR 522.3
- Linear iga disease — n=62, PRR 76.4
- Vanishing bile duct syndrome — n=28, PRR 51.1
- Chronic spontaneous urticaria — n=25, PRR 45.8
- Immune reconstitution syndrome — n=23, PRR 35.3
- Pyoderma gangrenosum — n=53, PRR 29.8
- Nocardiosis — n=38, PRR 29.7
- Drug reaction with eosinophilia and systemic symptoms — n=354, PRR 27.7
- Pneumonia pseudomonal — n=21, PRR 27.7
✓ A hand-written Bradford Hill causality assessment exists for this drug: Dapsone ↔ Methaemoglobinaemia / haemolysis.
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 Dapsone?
In FDA FAERS, the most frequently co-reported reaction terms for Dapsone are nausea, methaemoglobinaemia, fatigue, pyrexia, diarrhoea, rash. 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 Dapsone have an FDA boxed warning?
No. The FDA label retrieved for Dapsone has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Dapsone 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 0f1301f6-884d-4fc7-a5b2-421b2375b985, effective 20260709; matched on
openfda.generic_name.exact:"DAPSONE") - 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, 1,105 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.