Applies to danazol: oral capsules.
Warning
-
Fetotoxicity
- May cause fetal harm; contraindicated in pregnant women.b f Pregnancy must be excluded before the start of treatment and prevented thereafter by use of a nonhormonal method of contraception during therapy.b f (See Fetal/Neonatal Morbidity and Mortality under Cautions.)
-
Thrombotic Events
- Serious and potentially life-threatening thromboembolic events reported.b f (See Cardiovascular Effects under Cautions.)
-
Hepatic Effects
- Serious and potentially life-threatening hepatic effects (e.g., peliosis hepatis and benign hepatic adenoma resulting in intra-abdominal hemorrhage) reported with long-term therapy.b f (See Hepatic Effects under Cautions.)
- Administer lowest effective dosage.b f
- If therapy initiated at time of exacerbation of hereditary angioedema due to trauma, stress, or other causes, periodically attempt to decrease dosage or withdraw therapy.b f
-
Pseudotumor Cerebri
- Risk of pseudotumor cerebri (benign intracranial hypertension); manifested by papilledema, headache, nausea and vomiting, and/or visual disturbances.b f
- If signs and symptoms of pseudotumor cerebri occur, examine for the presence of papilledema; if present, discontinue danazol immediately and refer patient to a neurologist for further evaluation and care.b f
Side effects include:
Mild hirsutism, decreased breast size, voice changes, sore throat, acne, increased oiliness of skin or hair, hair loss, weight gain, edema, flushing, sweating, nervousness, emotional lability, vaginitis, menstrual irregularities.
For Healthcare Professionals
Applies to danazol: compounding powder, oral capsule.
General
The most commonly reported side effects included acne, edema, and flushing.[Ref]
Dermatologic
Very common (10% or more): Acne (up to 13%)
Common (1% to 10%): Facial edema, hair loss, hirsutism/mild hirsutism, maculopapular rash, papular rash, petechial rash, purpuric rash, seborrhea, sun sensitivity/sun sensitive rash, sweating, vesicular rash
Uncommon (0.1% to 1%): Pruritus, urticaria
Very rare (less than 0.01%): Erythema multiforme, inflammatory erythematous nodules, skin pigmentation/skin pigmentation change, Stevens-Johnson syndrome
Frequency not reported: Exfoliative dermatitis, rash[Ref]
Musculoskeletal
Common (1% to 10%): Arthralgia, backache/back pain, extremity pain, fasciculation, joint lock-up, joint swelling, muscle cramps, muscle spasms, muscle tremors, neck pain, spasms/pains
Rare (0.01% to 0.1%): Benign intracranial hypertension, dizziness
Very rare (less than 0.01%): Carpal tunnel syndrome
Frequency not reported: Altered creatine phosphokinase, creatinine phosphokinase increased, joint pain, limb pain[Ref]
Genitourinary
Common (1% to 10%): Amenorrhea/persistent amenorrhea/prolonged posttherapy amenorrhea, alteration in cycle timing, menstrual disturbances, pelvic pain, spotting, vaginal dryness/irritation
Uncommon (0.1% to 1%): Breast size changes
Rare (0.01% to 0.1%): Hypertrophy of the clitoris
Very rare (less than 0.01%): Abnormalities in semen volume/viscosity/sperm count/motility, hematuria, testicular atrophy
Frequency not reported: Bartholin's cyst, nipple discharge[Ref]
Psychiatric
Common (1% to 10%): Anxiety, depression/depressed mood, emotional lability, irritability, libido changes, nervousness
Frequency not reported: Sleep disorders[Ref]
Gastrointestinal
Common (1% to 10%): Constipation, gastroenteritis, indigestion, nausea, vomiting
Rare (0.01% to 0.1%): Pancreatitis
Very rare (less than 0.01%): Epigastric pain
Frequency not reported: Bleeding gums[Ref]
Respiratory
Common (1% to 10%): Hoarseness, pitch deepening/instability, sore throat, voice change
Uncommon (0.1% to 1%): Nasal congestion
Very rare (less than 0.01%): Interstitial pneumonitis, pleuritic pain[Ref]
Metabolic
Common (1% to 10%): Appetite changes, increased insulin requirements (in patients with diabetes), weight gain
Rare (0.01% to 0.1%): Fluid retention
Frequency not reported: Abnormal glucagon, abnormal glucose tolerance, altered glucose tolerance, altered glucagon, decreased apolipoproteins AI and AII, decreased high density lipoprotein cholesterol, increased total cholesterol/low density lipoprotein cholesterol, induction of amino levulinic acid synthetase[Ref]
Cardiovascular
Common (1% to 10%): Edema, flushing
Rare (0.01% to 0.1%): Arterial thrombosis, blood pressure elevation, hypertension/hypertension exacerbation, palpitation/palpitation exacerbation, tachycardia/tachycardia exacerbation, thrombotic events
Frequency not reported: Myocardial infarction[Ref]
Nervous system
Common (1% to 10%): Headache
Rare (0.01% to 0.1%): Faintness, vertigo, tremor
Very rare (less than 0.01%): Epilepsy aggravation, migraine/migraine provocation
Frequency not reported: Benign intracranial hypertension, cerebrovascular thrombosis, convulsions, dizziness, Guillain-Barre syndrome, paresthesia, sagittal sinus thrombosis[Ref]
Other
Common (1% to 10%): Fever
Rare (0.01% to 0.1%): Fatigue, weakness
Frequency not reported: Altered plasma proteins, chills, fasciculation[Ref]
Hepatic
Uncommon (0.1% to 1%): Hepatic dysfunction
Rare (0.01% to 0.1%): Cholestatic jaundice, hepatic adenoma
Very rare (less than 0.01%): Malignant hepatic tumor, peliosis hepatitis
Frequency not reported: Benign hepatic adenomata, hepatic failure, hepatocellular focal nodular hyperplasia, hepatocellular injury, hepatocellular jaundice, increased AST, jaundice, serum transaminase level increases, reversible elevated serum enzymes[Ref]
Hematologic
Rare (0.01% to 0.1%): Increased platelet count, increased red cell count, leukopenia, polycythemia/reversible polycythemia, thrombocytopenia
Very rare (less than 0.01%): Eosinophilia/reversible eosinophilia, reversible erythrocytosis, splenic peliosis
Frequency not reported: Leukocytosis[Ref]
Ocular
Rare (0.01% to 0.1%): Blurred vision, difficulty wearing contact lenses, focusing difficulty, refraction disorders requiring correction
Frequency not reported: Cataracts[Ref]
Endocrine
Frequency not reported: Altered sex hormone binding globulin, blunted cyclical surges of luteinizing hormone (LH), decreased protein bound iodine, decreased thyroid binding globulin and T4, increased T3 uptake, no disturbance of thyroid stimulating hormone/free thyroxine index[Ref]
Oncologic
Frequency not reported: Malignant liver tumors[Ref]
Hypersensitivity
Frequency not reported: Hereditary angioedema[Ref]
