Classifications: androgen/anabolic steroid; Therapeutic: anabolic steroid
Pregnancy Category: X
50 mg, 100 mg, 200 mg capsules
Synthetic androgen steroid; derivative of testosterone with dose-related mild androgenic effects but no estrogenic or progestational
activity. Suppresses pituitary output of FSH and LH, resulting in anovulation and associated amenorrhea.
Interrupts progress and pain of endometriosis by causing atrophy and involution of both normal and ectopic endometrial tissue.
Palliative treatment of endometriosis when alternative hormonal therapy is ineffective, contraindicated, or intolerable.
Also used to treat fibrocystic breast disease and hereditary angioedema.
To treat precocious puberty, gynecomastia, menorrhagia, premenstrual syndrome (PMS), chronic immune thrombocytopenic purpura
(ITP), autoimmune hemolytic anemia, hemophilia A and B.
Pregnancy (category X), lactation; children; undiagnosed abnormal genital bleeding; impaired renal, cardiac, or hepatic
function; porphyria; vaginal bleeding.
Migraine headache, epilepsy; seizure disorders; elderly.
Route & Dosage
Adult: PO 400 mg b.i.d. for 36 mo, start during menstruation or if pregnancy test is negative, may extended to 9 mo if necessary.
Do not repeat regimen.
Fibrocystic Breast Disease
Adult: PO 100400 mg in 2 divided doses, start during menstruation or if pregnancy test is negative
Adult: PO 200 mg b.i.d. or t.i.d., may decrease by 50% at intervals of 13 mo or longer, start during menstruation or if pregnancy
test is negative
- Start therapy during menstruation, or after a negative pregnancy test.
- Store capsules at 15°30° C (59°86° F) in tightly closed container.
Adverse Effects (≥1%)Body as a Whole:
Hypersensitivity (skin rashes, nasal congestion). Endocrine:
Androgenic effects (acne, mild hirsutism, deepening of voice, oily skin and hair, hair loss, edema, weight gain, pitch breaks,
voice weakness, decrease in breast size); hypoestrogenic effects (hot flashes;
sweating; emotional lability; nervousness; vaginitis
with itching, drying, burning, or bleeding; amenorrhea, irregular menstrual patterns);
impairment in glucose tolerance. CNS:
Dizziness, sleep disorders, fatigue
, tremor, irritability. Special Senses:
Conjunctival edema. CV:
Elevated BP. GI:
Gastroenteritis, hepatic damage
(rare), increased LDL, decreased HDL. Urogenital:
Decreased libido. Musculoskeletal:
Joint lock-up, joint swelling.
possibility of increased hepatotoxicity.
Other pharmacokinetic information is not known. Half-Life:
Assessment & Drug Effects
- Routine breast examinations should be carried out during therapy. Carcinoma of the breast should be ruled out prior to start
of therapy for fibrocystic breast disease. Advise patient to report to physician if any nodule enlarges or becomes tender
or hard during therapy.
- Because danazol may cause fluid retention, patients with cardiac or renal dysfunction, epilepsy, or migraine should be observed
closely during therapy, as these problems could worsen. Monitor weight.
- Drug-induced edema may compress the median nerve, producing symptoms of carpal tunnel syndrome. If patient complains of wrist
pain that worsens at night, paresthesias in radial palmar aspect of the hand and fingers, consult physician.
- Lab tests: Baseline and periodic liver function tests should be performed in all patients. Patients with diabetes (or history
of) should have blood glucose tests.
Patient & Family Education
- Note: Pain and discomfort are usually relieved in 2 or 3 mo; the nodularity in 46 mo. Menses may be regular or irregular
in pattern during therapy.
- Note: Drug-induced amenorrhea is reversible. Ovulation and cyclic bleeding usually return within 6090 d after therapeutic
regimen is discontinued as well as the potential for conception.
- Use a nonhormonal contraceptive during treatment because ovulation may not be suppressed until 68 wk after therapy
is begun. If pregnancy occurs while taking this drug, discontinue danazol. Continue discussing the question of continuing
the pregnancy considered.
- Report voice changes promptly. Stop drug to avoid permanent damage to voice. Virilizing adverse effects may persist even
after drug therapy is terminated.