Danocrine Side Effects

Generic name: danazol

Medically reviewed by Drugs.com. Last updated on Nov 17, 2022.

Note: This document contains side effect information about danazol. Some dosage forms listed on this page may not apply to the brand name Danocrine.

Applies to danazol: oral capsules.

Warning

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.)

Serious and potentially life-threatening thromboembolic events reported.^b ^f (See Cardiovascular Effects under Cautions.)

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]