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What the label lists and what reports show

Danazol side effects

Danazol's FDA label lists its adverse reactions in its own words. FAERS holds 2,803 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is headache (340 reports).

  • Generic listed
  • Boxed warning

Check it at the source: the danazol FDA label on DailyMed (effective April 30, 2020, Lannett Company, Inc.); the FDA FAERS public dashboard.

What does the label list?

From the label: adverse reactions

The following events have been reported in association with the use of danazol capsules: Androgen like effects include weight gain, acne and seborrhea. Mild hirsutism, edema, hair loss, voice change, which may take the form of hoarseness, sore throat or of instability or deepening of pitch, may occur and may persist after cessation of therapy. Hypertrophy of the clitoris is rare. Other possible endocrine effects are menstrual disturbances including spotting, alteration of the timing of the cycle and amenorrhea. Although cyclical bleeding and ovulation usually return within 60-90 days after discontinuation of therapy with danazol capsules, persistent amenorrhea has occasionally been reported. Flushing, sweating, vaginal dryness and irritation and reduction in breast size, may reflect lowering of estrogen. Nervousness and emotional lability have been reported. …

Source: FDA drug label, Lannett Company, Inc., effective April 30, 2020 (SPL set f2c9b713-aafc-49ca-866e-334d9b5c2e2d), via openFDA; the full label on DailyMed

What do FAERS reports show?

2,803 reports list danazol among the medicines taken, each a report of something that happened, not proof the medicine caused it; 376 are coded as a death and 983 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 18 reactions below, 5 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.

Reports received each year

The 25 most reported reactions

  • Drug Ineffective (a use or a product term, not a reaction)463
  • Off Label Use (a use or a product term, not a reaction)442
  • Headache (named in the label)340
  • Angioedema (a use or a product term, not a reaction)248
  • Hypersensitivity247
  • Drug Intolerance236
  • Dysphonia233
  • Swelling Face233
  • Swollen Tongue228
  • Hereditary Angioedema (a use or a product term, not a reaction)226
  • Drug Ineffective For Unapproved Indication (a use or a product term, not a reaction)204
  • Platelet Count Decreased192
  • Fatigue (named in the label)184
  • Nausea (named in the label)179
  • Product Use In Unapproved Indication (a use or a product term, not a reaction)156
  • Haemoglobin Decreased146
  • Death (an outcome recorded in the report)141
  • Constipation (named in the label)129
  • Asthenia123
  • Thrombocytopenia (named in the label)120
  • Anaemia110
  • Hepatic Enzyme Increased110
  • Pain104
  • Neutropenia103
  • Haemolysis101

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms

What next?

Danazol: the full record
label, generics, price, shortages, recalls
Side effects hub
the most reported medicines and reactions