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Danocrine Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Danocrine (danazol) is a steroid used to treat endometriosis and fibrocystic breast disease. It is also used to prevent attacks of angioedema in people with an inherited form of this disorder. The brand name of this medication is discontinued, but generic versions may be available. Common side effects include acne or other skin problems; increased hair growth or hair loss; weight gain; breast changes; deepened voice; nervousness; increased sweating, warmth or tingly feeling under your skin; changes in your menstrual periods; or vaginal dryness, discomfort, or itching.
In moderate to severe disease, or in patients infertile due to endometriosis, a starting dose of 800 mg Danocrine given in two divided doses is recommended. The total daily dosage of Danocrine for fibrocystic breast disease ranges from 100 mg to 400 mg given in two divided doses depending upon patient response. Danocrine may interact with blood thinners, or carbamazepine. Tell your doctor all medications and supplements you use. Danocrine can cause birth defects. Do not use Danocrine if you are pregnant. Tell your doctor if you become pregnant during treatment. Before you start taking Danocrine, you may need to have a pregnancy test to make sure you are not pregnant. Use an effective barrier form of birth control (such as a condom or diaphragm with spermicide gel or inserts). Hormonal contraception (such as birth control pills, injections, implants, skin patches, and vaginal rings) may not be effective to prevent pregnancy during treatment. Breastfeeding is not recommended while using this drug.
Our Danocrine (danazol) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Danocrine in Detail - Patient Information: Side Effects
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have any of these serious side effects:
- sudden numbness or weakness, confusion, problems with vision, speech, or balance;
- chest pain, sudden cough, wheezing, rapid breathing, fast heart rate;
- swelling, rapid weight gain, feeling short of breath;
- headache, ringing in your ears, dizziness, nausea, vision problems, pain behind your eyes; or
- stomach pain, loss of appetite, dark urine, jaundice (yellowing of the skin or eyes).
Less serious side effects may include:
- acne or other skin problems;
- increased hair growth or hair loss;
- weight gain;
- breast changes;
- deepened voice;
- increased sweating, warmth or tingly feeling under your skin;
- changes in your menstrual periods; or
- vaginal dryness, discomfort, or itching.
This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Danocrine (Danazol) »
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Danocrine FDA Prescribing Information: Side Effects
The following events have been reported in association with the use of DANOCRINE:
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 DANOCRINE, 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. In the male a modest reduction in spermatogenesis may be evident during treatment. Abnormalities in semen volume, viscosity, sperm count, and motility may occur in patients receiving long-term therapy.
Hepatic dysfunction, as evidenced by reversible elevated serum enzymes and/or jaundice, has been reported in patients receiving a daily dosage of DANOCRINE of 400 mg or more. It is recommended that patients receiving DANOCRINE be monitored for hepatic dysfunction by laboratory tests and clinical observation. Serious hepatic toxicity including cholestatic jaundice, peliosis hepatis, and hepatic adenoma have been reported. (See WARNINGS and PRECAUTIONS.)
Abnormalities in laboratory tests may occur during therapy with DANOCRINE including CPK, glucose tolerance, glucagon, thyroid binding globulin, sex hormone binding globulin, other plasma proteins, lipids and lipoproteins.
The following reactions have been reported, a causal relationship to the administration of DANOCRINE has neither been confirmed nor refuted; allergic: urticaria, pruritus and rarely, nasal congestion; CNS effects: headache, nervousness and emotional lability, dizziness and fainting, depression, fatigue, sleep disorders, tremor, paresthesias, weakness, visual disturbances, and rarely, benign intracranial hypertension, anxiety, changes in appetite, chills, and rarely convulsions, Guillain-Barre syndrome; gastrointestinal: gastroenteritis, nausea, vomiting, constipation, and rarely, pancreatitis and splenic peliosis; musculoskeletal: muscle cramps or spasms, or pains, joint pain, joint lockup, joint swelling, pain in back, neck, or extremities, and rarely, carpal tunnel syndrome which may be secondary to fluid retention; genitourinary: hematuria, prolonged posttherapy amenorrhea; hematologic: an increase in red cell and platelet count. Reversible erythrocytosis, leukocytosis or polycythemia may be provoked. Eosinophilia, leukopenia and thrombocytopenia have also been noted. Skin: rashes (maculopapular, vesicular, papular, purpuric, petechial), and rarely, sun sensitivity, Stevens-Johnson syndrome and erythema multiforme; other: increased insulin requirements in diabetic patients, change in libido, myocardial infarction, palpitation, tachycardia, elevation in blood pressure, interstitial pneumonitis, and rarely, cataracts, bleeding gums, fever, pelvic pain, nipple discharge. Malignant liver tumors have been reported in rare instances, after long-term use.
Read the entire FDA prescribing information for Danocrine (Danazol) »
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