Drug · FAERS side-effect profile with label screen
Danazol side effects: what 2,802 FDA adverse event reports show
Who reports
2,802 reports · 84% serious · 376 with death outcome · 56% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Endometriosis Danazol capsules are indicated for the treatment of endometriosis amenable to hormonal management. Hereditary Angioedema Danazol capsules are indicated for the prevention of attacks of angioedema of all types (cutaneous, abdominal, laryngeal) in males and females.
FDA label, Indications and Usage
What it is
DESCRIPTION Danazol, USP is a synthetic steroid derived from ethisterone. It is a white to pale yellow crystalline powder, practically insoluble or insoluble in water, and sparingly soluble in alcohol.
FDA label, Description section
Boxed warning
Use of danazol in pregnancy is contraindicated. A sensitive test (e.g., beta subunit test if available) capable of determining early pregnancy is recommended immediately prior to start of therapy. Additionally a non-hormonal method of contraception should be used during therapy.
FDA 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 2Labeled (related wording) 2Likely indication confounding 2Reporting / coding artifact 6Lab value / disease marker 7Not in label — unassessed 21
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.
- 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. 124 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 |
|---|---|---|---|---|---|---|
| Hereditary angioedema | 226 | 164.5 144.9–186.7ROR 178.8 · χ² 35,781 / p <1e-300 | 158.8 EB05 142.2 · IC025 +6.7 3/3 methods agree | Likely indication confounding term in indications | serious PRR 118.4 | no trial data cached |
| Swollen tongue | 228 | 54.9 48.5–62.2ROR 59.7 · χ² 11,948 / p <1e-300 | 54.3 EB05 48.6 · IC025 +5.4 3/3 methods agree | Not in label — unassessed | serious PRR 52.6 · ♀ 99% (drug 56%) | no trial data cached |
| Angioedema (deep swelling of face/throat) | 248 | 42.2 37.5–47.6ROR 46.3 · χ² 9,911 / p <1e-300 | 41.9 EB05 37.7 · IC025 +5.1 3/3 methods agree | Likely indication confounding term in indications | serious PRR 30.5 · ♀ 97% (drug 56%) | no trial data cached |
| Dysphonia | 233 | 29.9 26.5–33.9ROR 32.6 · χ² 6,481 / p <1e-300 | 29.8 EB05 26.7 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious PRR 38.1 · ♀ 100% (drug 56%) | no trial data cached |
| Drug ineffective for unapproved indication | 204 | 27.5 24.1–31.4ROR 29.5 · χ² 5,171 / p <1e-300 | 27.3 EB05 24.3 · IC025 +4.5 3/3 methods agree | Reporting / coding artifact | serious PRR 41.6 · ♀ 91% (drug 56%) | no trial data cached |
| Swelling face | 233 | 26.9 23.8–30.4ROR 29.2 · χ² 5,778 / p <1e-300 | 26.7 EB05 24.0 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious PRR 30.1 · ♀ 98% (drug 56%) | no trial data cached |
| Splenomegaly | 38 | 24.3 17.7–33.4ROR 24.7 · χ² 825 / p 9e-182 | 24.0 EB05 18.3 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious PRR 18.3 | no trial data cached |
| Myelodysplastic syndrome | 40 | 20.7 15.2–28.2ROR 21.0 · χ² 730 / p 5e-161 | 20.5 EB05 15.7 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 14.4 · ♀ 18% (drug 56%) | no trial data cached |
| Platelet count increased | 34 | 19.5 14.0–27.3ROR 19.7 · χ² 577 / p 7e-128 | 19.3 EB05 14.4 · IC025 +3.4 3/3 methods agree | Lab value / disease marker | serious PRR 16.6 | no trial data cached |
| Drug intolerance | 236 | 18.4 16.3–20.8ROR 20.0 · χ² 3,869 / p <1e-300 | 18.3 EB05 16.4 · IC025 +3.9 3/3 methods agree | Reporting / coding artifact | serious PRR 20.5 · ♀ 96% (drug 56%) | no trial data cached |
| Petechiae | 21 | 15.1 9.9–23.2ROR 15.2 · χ² 263 / p 2e-59 | 14.6 EB05 9.7 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 12.0 | no trial data cached |
| Gingival bleeding | 27 | 14.8 10.2–21.5ROR 14.9 · χ² 333 / p 1e-74 | 14.4 EB05 10.1 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 15.2 | no trial data cached |
| Platelet count decreased | 193 | 13.6 11.8–15.6ROR 14.5 · χ² 2,242 / p <1e-300 | 13.5 EB05 12.0 · IC025 +3.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 10.5 | no trial data cached |
| Therapeutic product effect decreased | 76 | 12.8 10.3–16.0ROR 13.2 · χ² 817 / p 5e-180 | 12.7 EB05 10.4 · IC025 +3.2 3/3 methods agree | Reporting / coding artifact | serious PRR 17.2 · ♀ 0% (drug 56%) · 100% clinician | no trial data cached |
| Blood lactate dehydrogenase increased | 27 | 12.7 8.7–18.5ROR 12.8 · χ² 279 / p 7e-63 | 12.1 EB05 8.4 · IC025 +2.7 3/3 methods agree | Lab value / disease marker | serious PRR 7.6 | no trial data cached |
| Hepatic enzyme increased | 110 | 12.1 10.1–14.6ROR 12.6 · χ² 1,113 / p 2e-244 | 12.0 EB05 10.2 · IC025 +3.2 3/3 methods agree | Lab value / disease marker | serious PRR 11.7 · ♀ 17% (drug 56%) · 92% clinician | no trial data cached |
| Incorrect route of product administration | 27 | 12.0 8.3–17.5ROR 12.1 · χ² 262 / p 3e-59 | 11.4 EB05 7.9 · IC025 +2.7 3/3 methods agree | Reporting / coding artifact | serious PRR 5.5 · 70% consumer | no trial data cached |
| Infusion related reaction (reaction during infusion) | 98 | 11.1 9.1–13.5ROR 11.5 · χ² 893 / p 2e-196 | 10.9 EB05 9.2 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 9.4 · ♀ 6% (drug 56%) · 97% clinician | no trial data cached |
| Body height decreased | 16 | 11.1 6.8–18.1ROR 11.1 · χ² 137 / p 7e-32 | 9.8 EB05 6.0 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious n=15 | no trial data cached |
| Haemoglobin decreased | 147 | 10.7 9.1–12.5ROR 11.2 · χ² 1,287 / p 4e-282 | 10.6 EB05 9.2 · IC025 +3.1 3/3 methods agree | Lab value / disease marker | serious PRR 7.4 | no trial data cached |
| Hepatomegaly | 14 | 10.6 6.3–17.9ROR 10.7 · χ² 112 / p 1e-26 | 9.1 EB05 5.4 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 7.9 | no trial data cached |
| Rhabdomyolysis (muscle breakdown) | 58 | 10.4 8.1–13.5ROR 10.6 · χ² 486 / p 7e-108 | 10.1 EB05 8.0 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 7.1 · ♀ 25% (drug 56%) · 100% clinician | no trial data cached |
| Hypersensitivity (allergic reaction) | 247 | 10.0 8.9–11.2ROR 10.8 · χ² 2,001 / p <1e-300 | 9.9 EB05 8.9 · IC025 +3.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 12.7 · ♀ 97% (drug 56%) | no trial data cached |
| Acute myeloid leukaemia | 20 | 9.6 6.2–14.9ROR 9.7 · χ² 146 / p 7e-34 | 8.6 EB05 5.6 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 6.6 | no trial data cached |
| Nephropathy toxic | 12 | 8.1 4.6–14.2ROR 8.1 · χ² 67 / p 1e-16 | 6.5 EB05 3.9 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 5.7 | no trial data cached |
| Thrombocytopenia (low platelets) | 120 | 8.1 6.8–9.6ROR 8.4 · χ² 738 / p 1e-162 | 7.9 EB05 6.7 · IC025 +2.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.7 · ♀ 35% (drug 56%) | no trial data cached |
| Bone marrow failure | 22 | 8.0 5.3–12.2ROR 8.1 · χ² 129 / p 4e-30 | 7.1 EB05 4.9 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 5.6 | no trial data cached |
| Transfusion | 11 | 7.8 4.3–14.1ROR 7.9 · χ² 59 / p 9e-15 | 6.2 EB05 3.6 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 5.1 | no trial data cached |
| Acute myocardial infarction | 30 | 7.6 5.3–10.8ROR 7.7 · χ² 165 / p 5e-38 | 6.9 EB05 5.0 · IC025 +2.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.2 · ♀ 22% (drug 56%) · 93% clinician | no trial data cached |
| Migraine | 94 | 7.4 6.1–9.0ROR 7.6 · χ² 517 / p 9e-115 | 7.2 EB05 6.0 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 9.9 · ♀ 15% (drug 56%) · 91% clinician | no trial data cached |
| Blood count abnormal | 15 | 7.3 4.4–12.1ROR 7.3 · χ² 75 / p 2e-18 | 6.2 EB05 3.9 · IC025 +1.7 3/3 methods agree | Lab value / disease marker | serious PRR 5.6 | no trial data cached |
| Hypercalcaemia | 11 | 6.7 3.7–12.0ROR 6.7 · χ² 48 / p 3e-12 | 5.4 EB05 3.2 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 4.9 | no trial data cached |
| Therapy non-responder | 39 | 6.5 4.8–8.9ROR 6.6 · χ² 178 / p 7e-41 | 6.1 EB05 4.7 · IC025 +2.1 3/3 methods agree | Reporting / coding artifact | serious PRR 7.2 · 92% clinician | no trial data cached |
| Multiple organ dysfunction syndrome | 24 | 6.4 4.3–9.6ROR 6.5 · χ² 105 / p 7e-25 | 5.8 EB05 4.1 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 4.4 · ♀ 0% (drug 56%) · 92% clinician | no trial data cached |
| Product availability issue | 19 | 6.3 4.1–9.9ROR 6.4 · χ² 80 / p 2e-19 | 5.6 EB05 3.8 · IC025 +1.7 3/3 methods agree | Reporting / coding artifact | serious PRR 7.1 | no trial data cached |
| Full blood count decreased | 17 | 6.3 3.9–10.1ROR 6.3 · χ² 71 / p 2e-17 | 5.5 EB05 3.6 · IC025 +1.6 3/3 methods agree | Lab value / disease marker | serious PRR 6.3 | no trial data cached |
| Insurance issue | 12 | 6.0 3.4–10.6ROR 6.1 · χ² 46 / p 7e-12 | 5.0 EB05 3.1 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 7.9 | no trial data cached |
| White blood cell count increased | 31 | 6.0 4.2–8.6ROR 6.1 · χ² 125 / p 2e-29 | 5.6 EB05 4.1 · IC025 +1.9 3/3 methods agree | Lab value / disease marker | serious PRR 4.5 | no trial data cached |
| Dermatitis allergic | 10 | 6.0 3.2–11.1ROR 6.0 · χ² 37 / p 6e-10 | 4.8 EB05 2.8 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 5.5 | no trial data cached |
| Chromaturia | 18 | 6.0 3.8–9.5ROR 6.0 · χ² 69 / p 4e-17 | 5.2 EB05 3.5 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 5.4 | 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) | 442 | 3.8 3.5–4.2ROR 4.3 · χ² 952 / p 2e-209 | 3.8 EB05 3.5 · IC025 +1.8 3/3 methods agree | Reporting / coding artifact | serious PRR 4.5 · ♀ 79% (drug 56%) | no trial data cached |
| Headache | 340 | 4.1 3.7–4.5ROR 4.5 · χ² 806 / p 2e-177 | 4.0 EB05 3.7 · IC025 +1.8 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 5.5 · ♀ 89% (drug 56%) | no trial data cached |
| Angioedema (deep swelling of face/throat) | 248 | 42.2 37.5–47.6ROR 46.3 · χ² 9,911 / p <1e-300 | 41.9 EB05 37.7 · IC025 +5.1 3/3 methods agree | Likely indication confounding term in indications | serious PRR 30.5 · ♀ 97% (drug 56%) | no trial data cached |
| Hypersensitivity (allergic reaction) | 247 | 10.0 8.9–11.2ROR 10.8 · χ² 2,001 / p <1e-300 | 9.9 EB05 8.9 · IC025 +3.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 12.7 · ♀ 97% (drug 56%) | no trial data cached |
| Drug intolerance | 236 | 18.4 16.3–20.8ROR 20.0 · χ² 3,869 / p <1e-300 | 18.3 EB05 16.4 · IC025 +3.9 3/3 methods agree | Reporting / coding artifact | serious PRR 20.5 · ♀ 96% (drug 56%) | no trial data cached |
| Swelling face | 233 | 26.9 23.8–30.4ROR 29.2 · χ² 5,778 / p <1e-300 | 26.7 EB05 24.0 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious PRR 30.1 · ♀ 98% (drug 56%) | no trial data cached |
| Dysphonia | 233 | 29.9 26.5–33.9ROR 32.6 · χ² 6,481 / p <1e-300 | 29.8 EB05 26.7 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious PRR 38.1 · ♀ 100% (drug 56%) | no trial data cached |
| Swollen tongue | 228 | 54.9 48.5–62.2ROR 59.7 · χ² 11,948 / p <1e-300 | 54.3 EB05 48.6 · IC025 +5.4 3/3 methods agree | Not in label — unassessed | serious PRR 52.6 · ♀ 99% (drug 56%) | no trial data cached |
| Hereditary angioedema | 226 | 164.5 144.9–186.7ROR 178.8 · χ² 35,781 / p <1e-300 | 158.8 EB05 142.2 · IC025 +6.7 3/3 methods agree | Likely indication confounding term in indications | serious PRR 118.4 | no trial data cached |
| Drug ineffective for unapproved indication | 204 | 27.5 24.1–31.4ROR 29.5 · χ² 5,171 / p <1e-300 | 27.3 EB05 24.3 · IC025 +4.5 3/3 methods agree | Reporting / coding artifact | serious PRR 41.6 · ♀ 91% (drug 56%) | no trial data cached |
| Platelet count decreased | 193 | 13.6 11.8–15.6ROR 14.5 · χ² 2,242 / p <1e-300 | 13.5 EB05 12.0 · IC025 +3.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 10.5 | no trial data cached |
| Product use in unapproved indication | 156 | 4.8 4.1–5.6ROR 5.0 · χ² 467 / p 6e-104 | 4.7 EB05 4.1 · IC025 +2.0 3/3 methods agree | Reporting / coding artifact | serious PRR 7.0 · ♀ 80% (drug 56%) | no trial data cached |
| Haemoglobin decreased | 147 | 10.7 9.1–12.5ROR 11.2 · χ² 1,287 / p 4e-282 | 10.6 EB05 9.2 · IC025 +3.1 3/3 methods agree | Lab value / disease marker | serious PRR 7.4 | no trial data cached |
| Constipation | 129 | 4.5 3.8–5.3ROR 4.6 · χ² 346 / p 1e-77 | 4.4 EB05 3.8 · IC025 +1.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.1 · ♀ 23% (drug 56%) | no trial data cached |
| Thrombocytopenia (low platelets) | 120 | 8.1 6.8–9.6ROR 8.4 · χ² 738 / p 1e-162 | 7.9 EB05 6.7 · IC025 +2.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.7 · ♀ 35% (drug 56%) | 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.
- Swollen tongue — n=228, PRR 54.9
- Dysphonia — n=233, PRR 29.9
- Swelling face — n=233, PRR 26.9
- Splenomegaly — n=38, PRR 24.3
- Myelodysplastic syndrome — n=40, PRR 20.7
- Petechiae — n=21, PRR 15.1
- Gingival bleeding — n=27, PRR 14.8
- Infusion related reaction — n=98, PRR 11.1
- Rhabdomyolysis — n=58, PRR 10.4
- Acute myeloid leukaemia — n=20, PRR 9.6
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 Danazol?
In FDA FAERS, the most frequently co-reported reaction terms for Danazol are headache, angioedema, hypersensitivity, swelling face, dysphonia, swollen tongue. 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 Danazol have an FDA boxed warning?
Yes. The current FDA label carries a boxed warning: Use of danazol in pregnancy is contraindicated. A sensitive test (e.g., beta subunit test if available) capable of determining early pregnancy is recommended immediately prior to start of therapy. Additionally a non-hormonal method of contraception should be used during therapy.
Do FAERS signals prove that Danazol 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 e19acee5-ff33-45a5-bbbf-801756bc59b4, effective 20221001; matched on
openfda.generic_name.exact:"DANAZOL") - 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, 164 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.