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Danazol Side Effects

The most commonly reported side effects of danazol include off label use, headache, and hypersensitivity, based on 2,802 FDA adverse event reports from 2004 to 2025. 13.6% of reports found the drug to be ineffective.

Danazol side effects

Percentages show how often each reaction appears relative to total reports for danazol.

1
Off Label Use14.4%404
2
Drug Ineffective13.6%382
3
Headache10.6%297
4
Hypersensitivity7.6%214
5
Angioedema7.6%212
6
Hereditary Angioedema7.5%211
7
Drug Intolerance7.3%205
8
Drug Ineffective For Unapproved Indication7.2%203
9
Dysphonia7.2%202
10
Swelling Face7.2%201
11
Swollen Tongue7.0%196
12
Platelet Count Decreased6.3%177
13
Nausea5.8%162
14
Fatigue5.6%157
15
Product Use In Unapproved Indication5.4%152

These are voluntary reports and do not establish that danazol caused these reactions.

Report severity

83.7%Serious2,345 reports
35.5%Hospitalizations996 reports
13.5%Fatal378 reports

Seriousness is determined by the reporter, not by OpenClaim.

Danazol drug interactions

Other drugs that appear in adverse event reports alongside danazol. Drugs flagged as a suspected cause appear in the first column. Drugs taken at the same time but not suspected appear in the second.

Also suspected

1
Dexamethasone11.7%327
2
Prednisone11.6%325
3
Romiplostim11.1%310
4
Cyclosporine9.1%254
5
Ruxolitinib8.8%246
6
Rituximab7.7%215
7
Sertraline-hydrochloride7.4%207
8
Icatibant-acetate7.4%206
9
Duloxetine-hydrochloride7.0%196
10
Hydromorphone-hydrochloride7.0%195
11
Clarithromycin7.0%195
12
Topiramate7.0%195
13
Eszopiclone6.9%194
14
Amoxicillin6.9%194
15
Lansoprazole6.9%194

Taken alongside

1
Prednisone15.3%429
2
Acetaminophen12.4%348
3
Pantoprazole-sodium12.2%343
4
Fluticasone10.8%303
5
Aspirin9.5%266
6
Omeprazole8.2%231
7
Albuterol7.9%222
8
Metoclopramide-hydrochloride7.9%220
9
Lisinopril7.7%215
10
Naproxen7.6%214
11
Fluoxetine-hydrochloride7.6%213
12
Furosemide7.4%208
13
Cephalexin7.4%207
14
Folic-acid7.3%205
15
Levothyroxine-sodium7.1%198

Co-occurrence in adverse event reports does not establish a drug interaction. Patients often take multiple medications, and these lists reflect prescribing patterns rather than causal relationships. Consult a healthcare provider about potential drug interactions.

Who reports danazol side effects

45.3% of danazol adverse event reports involve female patients and 36.7% involve male patients. The largest age group is adult at 60%. These figures reflect who reports side effects, not underlying risk.

Sex

Female45.3%
Male36.7%
Unknown18.0%

Age group

< 20.1%
2–112.3%
12–171.3%
18–6460.4%
65+35.9%

What is danazol used for

Conditions and purposes for which patients were taking danazol when the adverse event was reported.

Abdominal Pain UpperAcute Graft Versus Host Disease In SkinAcute Myeloid LeukaemiaAnaemiaAnaemia Haemolytic AutoimmuneAnaemia ProphylaxisAngioedemaAngioneurotic OedemaAntiphospholipid SyndromeAplasia Pure Red CellAplastic AnaemiaAppendicitisAutoimmune DermatitisAutoimmune DisorderAutoimmune Haemolytic Anaemia

Showing 15 of 156 indications

Danazol brand names and reporting trend

Danazol is sold under the brand name Danocrine.

Brand names

Danocrine3,218

Quarterly reports (20042025)

20052010201520202025

An upward trend reflects increased FAERS reporting overall, not necessarily increased risk.

Taking danazol with another medication?

Ask OpenClaim about your specific drug combination. Get a sourced report using FDA data, drug labels, and medical literature.