Drug · FAERS side-effect profile with label screen
Daspone side effects: what 9,681 FDA adverse event reports show
Drug class
Sulfone
FDA label (Established Pharmacologic Class)
Brand names
Dapsone
openFDA label
Who reports
9,681 reports · 81% serious · 919 with death outcome · 52% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Dapsone gel, 7.5%, is indicated for the topical treatment of acne vulgaris in patients 9 years of age and older. Dapsone gel, 7.5%, is a sulfone indicated for the topical treatment of acne vulgaris in patients 9 years of age and older (1) .
FDA label, Indications and Usage
What it is
Dapsone gel, 7.5%, contains dapsone USP, a sulfone, in an aqueous gel base for topical dermatologic use. Dapsone gel, 7.5% is an off-white to yellow gel with suspended 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. 1,042 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 | 1,068.0 596.9–1,911.1ROR 1,069.9 · χ² 11,380 / p <1e-300 | 394.9 EB05 261.1 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious n=16 | no trial data cached |
| Type 2 lepra reaction | 49 | 764.0 551.6–1,058.0ROR 767.9 · χ² 26,942 / p <1e-300 | 461.2 EB05 362.6 · IC025 +5.9 3/3 methods agree | Not in label — unassessed | serious n=48 · ♀ 20% (drug 52%) · 96% clinician | no trial data cached |
| Methaemoglobinaemia | 476 | 566.4 513.0–625.4ROR 595.7 · χ² 211,933 / p <1e-300 | 440.0 EB05 407.8 · IC025 +8.1 3/3 methods agree | Not in label — unassessed | serious n=462 · 96% clinician | no trial data cached |
| Lepromatous leprosy | 15 | 492.9 281.3–863.9ROR 493.7 · χ² 5,590 / p <1e-300 | 265.4 EB05 170.7 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious n=15 | no trial data cached |
| Blood methaemoglobin present | 19 | 446.0 272.1–730.9ROR 446.9 · χ² 6,615 / p <1e-300 | 269.2 EB05 182.2 · IC025 +4.4 3/3 methods agree | Lab value / disease marker | serious n=17 | no trial data cached |
| Aeromonas infection | 12 | 159.2 88.6–286.1ROR 159.4 · χ² 1,611 / p <1e-300 | 120.4 EB05 73.4 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious n=12 | no trial data cached |
| Alopecia scarring | 10 | 136.9 72.3–259.4ROR 137.1 · χ² 1,143 / p 6e-251 | 103.8 EB05 60.3 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious n=9 | no trial data cached |
| Dermatitis herpetiformis | 14 | 132.3 77.2–226.9ROR 132.5 · χ² 1,597 / p <1e-300 | 106.9 EB05 67.7 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious n=8 | no trial data cached |
| Leukaemoid reaction | 11 | 96.3 52.6–176.1ROR 96.4 · χ² 903 / p 9e-199 | 79.9 EB05 47.6 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Linear iga disease | 62 | 83.8 65.0–107.9ROR 84.3 · χ² 4,800 / p <1e-300 | 78.8 EB05 63.6 · IC025 +5.2 3/3 methods agree | Not in label — unassessed | serious n=61 · ♀ 81% (drug 52%) · 97% clinician | no trial data cached |
| Zygomycosis | 14 | 65.9 38.7–112.1ROR 66.0 · χ² 806 / p 1e-177 | 59.0 EB05 37.4 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious n=14 | no trial data cached |
| Pleocytosis | 15 | 57.5 34.5–96.0ROR 57.6 · χ² 757 / p 6e-167 | 52.5 EB05 33.8 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious n=15 | no trial data cached |
| Vanishing bile duct syndrome | 28 | 56.0 38.5–81.5ROR 56.2 · χ² 1,421 / p <1e-300 | 52.7 EB05 38.3 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious n=28 · ♀ 0% (drug 52%) · 100% clinician | no trial data cached |
| Antineutrophil cytoplasmic antibody positive | 17 | 51.7 32.0–83.7ROR 51.8 · χ² 777 / p 3e-171 | 48.0 EB05 31.7 · IC025 +3.6 3/3 methods agree | Lab value / disease marker | serious n=17 | no trial data cached |
| Chronic spontaneous urticaria | 25 | 50.2 33.8–74.6ROR 50.4 · χ² 1,131 / p 3e-248 | 47.4 EB05 33.8 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious n=21 · ♀ 100% (drug 52%) · 100% clinician | no trial data cached |
| Haemolytic anaemia | 164 | 40.2 34.5–46.9ROR 40.9 · χ² 6,120 / p <1e-300 | 39.3 EB05 34.5 · IC025 +4.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 27.5 · 93% clinician | no trial data cached |
| Disseminated cryptococcosis | 13 | 38.9 22.5–67.4ROR 39.0 · χ² 435 / p 5e-97 | 36.4 EB05 22.6 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious n=13 | no trial data cached |
| Immune reconstitution syndrome | 23 | 38.7 25.7–58.5ROR 38.8 · χ² 794 / p 5e-175 | 37.0 EB05 26.0 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious n=21 · ♀ 17% (drug 52%) | no trial data cached |
| Pyoderma gangrenosum | 53 | 32.6 24.9–42.8ROR 32.8 · χ² 1,571 / p <1e-300 | 31.8 EB05 25.3 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious n=53 | no trial data cached |
| Nocardiosis | 38 | 32.6 23.7–44.9ROR 32.7 · χ² 1,115 / p 9e-245 | 31.7 EB05 24.1 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious n=38 · ♀ 17% (drug 52%) · 100% clinician | no trial data cached |
| Steroid dependence | 12 | 31.0 17.5–54.8ROR 31.0 · χ² 314 / p 1e-70 | 29.3 EB05 17.8 · 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 | 30.4 27.4–33.7ROR 31.5 · χ² 9,911 / p <1e-300 | 30.0 EB05 27.4 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious PRR 21.3 · 99% clinician | no trial data cached |
| Toxoplasmosis | 15 | 30.4 18.3–50.6ROR 30.4 · χ² 392 / p 2e-87 | 29.0 EB05 18.6 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious n=15 | no trial data cached |
| Pneumonia pseudomonal | 21 | 30.3 19.7–46.6ROR 30.4 · χ² 559 / p 8e-124 | 29.2 EB05 20.1 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious n=21 · 100% clinician | no trial data cached |
| Product delivery mechanism issue | 58 | 26.1 20.2–33.8ROR 26.3 · χ² 1,360 / p 5e-298 | 25.6 EB05 20.6 · IC025 +4.0 3/3 methods agree | Reporting / coding artifact | 74% consumer | no trial data cached |
| Cushingoid | 38 | 25.8 18.7–35.5ROR 25.9 · χ² 870 / p 2e-191 | 25.2 EB05 19.2 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious n=36 · 100% clinician | no trial data cached |
| Mycobacterium avium complex infection | 31 | 25.5 17.9–36.3ROR 25.6 · χ² 697 / p 6e-154 | 24.9 EB05 18.4 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious n=30 · ♀ 21% (drug 52%) · 93% clinician | no trial data cached |
| Lupus nephritis | 20 | 23.8 15.3–37.0ROR 23.9 · χ² 410 / p 2e-91 | 23.1 EB05 15.7 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=20 · 100% clinician | no trial data cached |
| Brain abscess | 25 | 21.6 14.6–32.1ROR 21.7 · χ² 467 / p 8e-104 | 21.1 EB05 15.0 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious n=25 · ♀ 0% (drug 52%) · 92% clinician | no trial data cached |
| Haemolysis | 75 | 21.2 16.9–26.6ROR 21.3 · χ² 1,409 / p <1e-300 | 20.9 EB05 17.2 · IC025 +3.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 15.3 · 97% clinician | no trial data cached |
| Lymphadenitis | 23 | 20.8 13.8–31.3ROR 20.8 · χ² 410 / p 2e-91 | 20.3 EB05 14.1 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=23 · 100% clinician | no trial data cached |
| Acute febrile neutrophilic dermatosis | 22 | 20.8 13.7–31.6ROR 20.8 · χ² 391 / p 3e-87 | 20.2 EB05 14.0 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious n=22 | no trial data cached |
| Bone demineralisation | 10 | 20.6 11.0–38.3ROR 20.6 · χ² 166 / p 3e-38 | 19.2 EB05 10.3 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious n=9 | no trial data cached |
| Cytomegalovirus test positive | 16 | 19.7 12.1–32.3ROR 19.8 · χ² 264 / p 1e-59 | 19.0 EB05 12.1 · IC025 +2.8 3/3 methods agree | Lab value / disease marker | serious n=15 | no trial data cached |
| Infection reactivation | 10 | 19.1 10.2–35.5ROR 19.1 · χ² 152 / p 3e-35 | 17.6 EB05 9.2 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Necrotising fasciitis | 30 | 18.6 13.0–26.6ROR 18.7 · χ² 478 / p 3e-106 | 18.2 EB05 13.3 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=29 · 100% clinician | no trial data cached |
| Pemphigoid | 62 | 18.3 14.2–23.4ROR 18.4 · χ² 986 / p 8e-217 | 18.0 EB05 14.5 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious PRR 12.7 | no trial data cached |
| Cytomegalovirus viraemia | 34 | 16.9 12.1–23.7ROR 17.0 · χ² 491 / p 5e-109 | 16.6 EB05 12.3 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=33 · ♀ 20% (drug 52%) | no trial data cached |
| Cutaneous lupus erythematosus | 15 | 16.7 10.0–27.7ROR 16.7 · χ² 204 / p 1e-46 | 15.8 EB05 9.6 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious n=15 | no trial data cached |
| Accidental poisoning | 10 | 16.1 8.7–30.1ROR 16.2 · χ² 126 / p 1e-29 | 14.5 EB05 7.2 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious n=10 | 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) | 1,196 | 3.0 2.8–3.2ROR 3.3 · χ² 1,645 / p <1e-300 | 3.0 EB05 2.8 · IC025 +1.5 3/3 methods agree | Reporting / coding artifact | serious PRR 3.3 | no trial data cached |
| Drug ineffective (drug did not work) | 1,009 | 1.7 1.6–1.8ROR 1.7 · χ² 282 / p 2e-63 | 1.7 EB05 1.6 · IC025 +0.6 | Reporting / coding artifact | serious PRR 2.7 | no trial data cached |
| Methaemoglobinaemia | 476 | 566.4 513.0–625.4ROR 595.7 · χ² 211,933 / p <1e-300 | 440.0 EB05 407.8 · IC025 +8.1 3/3 methods agree | Not in label — unassessed | serious n=462 · 96% clinician | no trial data cached |
| Pyrexia (fever) | 457 | 2.9 2.6–3.1ROR 3.0 · χ² 560 / p 5e-124 | 2.9 EB05 2.6 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 2.4 | no trial data cached |
| Fatigue (tiredness) | 454 | 1.3 1.2–1.4ROR 1.3 · χ² 26 / p 2e-7 | 1.3 EB05 1.2 · IC025 +0.2 | Not in label — unassessed | serious PRR 1.3 | no trial data cached |
| Nausea | 453 | 1.2 1.1–1.4ROR 1.3 · χ² 22 / p 1e-6 | 1.2 EB05 1.2 · IC025 +0.2 | Not in label — unassessed | serious PRR 1.3 | no trial data cached |
| Diarrhoea (diarrhea) | 399 | 1.3 1.2–1.5ROR 1.4 · χ² 36 / p 1e-9 | 1.3 EB05 1.2 · IC025 +0.3 | Not in label — unassessed | serious PRR 1.3 | no trial data cached |
| Pneumonia (lung infection) | 383 | 2.6 2.3–2.8ROR 2.6 · χ² 370 / p 8e-83 | 2.6 EB05 2.4 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 1.9 | no trial data cached |
| Dyspnoea (shortness of breath) | 366 | 1.4 1.3–1.5ROR 1.4 · χ² 43 / p 3e-11 | 1.4 EB05 1.3 · IC025 +0.3 | Not in label — unassessed | serious PRR 1.2 | no trial data cached |
| Anaemia (low red blood cells) | 357 | 4.1 3.7–4.5ROR 4.2 · χ² 825 / p 9e-182 | 4.0 EB05 3.7 · IC025 +1.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.0 | no trial data cached |
| Drug reaction with eosinophilia and systemic symptoms | 354 | 30.4 27.4–33.7ROR 31.5 · χ² 9,911 / p <1e-300 | 30.0 EB05 27.4 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious PRR 21.3 · 99% clinician | no trial data cached |
| Pain | 348 | 1.2 1.1–1.4ROR 1.2 · χ² 15 / p 7e-5 | 1.2 EB05 1.1 · IC025 +0.1 | Not in label — unassessed | serious PRR 1.2 | no trial data cached |
| Rash | 347 | 1.7 1.6–1.9ROR 1.8 · χ² 109 / p 7e-26 | 1.7 EB05 1.6 · IC025 +0.6 | Labeled adverse reaction exact term | serious PRR 2.0 | no trial data cached |
| Treatment failure | 344 | 9.1 8.2–10.1ROR 9.4 · χ² 2,475 / p <1e-300 | 9.0 EB05 8.2 · IC025 +3.0 3/3 methods agree | Reporting / coding artifact | serious PRR 11.3 · ♀ 75% (drug 52%) | no trial data cached |
| Condition aggravated | 343 | 2.5 2.2–2.7ROR 2.5 · χ² 300 / p 2e-67 | 2.5 EB05 2.2 · IC025 +1.1 3/3 methods agree | Reporting / coding artifact | serious PRR 2.4 | 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 764.0
- Methaemoglobinaemia — n=476, PRR 566.4
- Linear iga disease — n=62, PRR 83.8
- Vanishing bile duct syndrome — n=28, PRR 56.0
- Chronic spontaneous urticaria — n=25, PRR 50.2
- Immune reconstitution syndrome — n=23, PRR 38.7
- Pyoderma gangrenosum — n=53, PRR 32.6
- Nocardiosis — n=38, PRR 32.6
- Drug reaction with eosinophilia and systemic symptoms — n=354, PRR 30.4
- Pneumonia pseudomonal — n=21, PRR 30.3
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 Daspone?
In FDA FAERS, the most frequently co-reported reaction terms for Daspone are methaemoglobinaemia, pyrexia, fatigue, nausea, diarrhoea, pneumonia. 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 Daspone have an FDA boxed warning?
No. The FDA label retrieved for Daspone has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Daspone 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 fba0b181-077a-4667-bde1-cf9592f120c2, effective 20230531; matched on
openfda.generic_name.exact:"DASPONE") - 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, 1,082 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.