Common uses

Danazol may be used for a number of different medical problems. These include treatment of:
• Pain and/or infertility due to endometriosis;
• A tendency for females to develop cysts in the breasts (fibrocystic breast disease); or
• Hereditary angioedema, which causes swelling of the face, arms, legs, throat, windpipe, bowels, or sexual organs.

Before using

Some medical conditions may interact with Danazol. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
• if you are planning to become pregnant
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have a history of blood clots or stroke, cancer, heart failure, heart disease, or liver or kidney problems

Directions

Take Danazol capsules by mouth. Follow the directions on the prescription label. Swallow the capsules with a drink of water. Take your doses at regular intervals. Do not take your medicine more often than directed.

Contact your pediatrician or health care professional regarding the use of this medicine in children. Special care may be needed.

Cautions

Thromboembolism, thrombotic and thrombophlebitic events including sagittal sinus thrombosis and life threatening have been reported.
Experience with long-term Danazol therapy is limited. Serious toxicity including cholestatic jaundice has been reported. Peliosis hepatis, benign hepatic adenoma and hepatic carcinoma have been observed with long-term use. Peliosis hepatis, hepatic adenoma and hepatic carcinoma may be silent until complicated by acute, potentially life-threatening intraabdominal haemorrhage. The physician should therefore be alert to this possibility. In patients with HAE attempts should be made to determine the lowest dose that will provide adequate protection. If the drug was begun at a time of exacerbation of HAE due to trauma, stress or other cause, periodic attempts to decrease or withdraw therapy should be considered.

Possible side effects

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Acne; changes in menstrual flow; changes in semen volume and sperm count; emotional problems; excessively oily skin; flushing; hair loss; nervousness; reduction in breast size; sweating; vaginal itching or dryness; voice changes (hoarseness, sore throat, change in pitch); weight gain.
Seek medical attention right away if any of these SEVERE side effects occur:
Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); abnormal hair growth; arm or leg pain; breathing trouble; chest pain; dark urine; dizziness; fainting; headache; nausea; one-sided weakness; slurred speech; sore throat or fever; stomach pain; swelling; unusual bleeding or bruising; vision problems; vomiting; yellowing of the skin or eyes.

If you take too much

If overdose is suspected, contact your local poison control center or emergency room immediately.

Additional information

Danazol inhibits ovulation in many women but pregnancies can occur if barrier contraception is not used. Virilization of the foetus can result from use beyond the 8th week of pregnancy. Therefore it is essential that barrier methods of contraception are used during Danazol treatment. Pregnancy should be excluded before commencing therapy and therapy should commence during menstruation. If a patient becomes pregnant while taking danazol, administration of the drug should be discontinued and the patient should be apprised of the potential risk to the foetus. If a patient suspects she has become pregnant during treatment, she should cease danazol treatment and consult her physician. Exposure to danazol in utero may result in androgenic effects on the female foetus; reports to date comprise clitoral hypertrophy, labial fusion, urogenital sinus defect, vaginal atresia and ambiguous genitalia.

Drug interactions

Tell your health care provider if you are taking any other medicines, especially any of the following:
• Anticoagulants (eg, warfarin), carbamazepine, cyclosporine, or macrolide immunosuppressants (eg, tacrolimus) because the actions and side effects of these medicines may be increased
This may not be a complete list of all interactions that may occur. Ask your health care provider if Danazol may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.