Danazol is a man-made form of a steroid. Danazol affects the ovaries and pituitary gland and prevents the release of certain hormones in the body.

Danazol is used to treat endometriosis and fibrocystic breast disease. Danazol is also used to prevent attacks of angioedema in people with an inherited form of this disorder.

Danazol may also be used for other purposes not listed in this medication guide.

You should not use this medication if you are allergic to danazol, or if you have porphyria, or severe problems with your heart, liver, or kidney. You also should not take danazol if you are pregnant or breast-feeding, or if you have abnormal vaginal bleeding that has not been checked by a doctor.

This medication can cause birth defects. Do not use if you are pregnant.

Before you start taking danazol, 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 forms of contraception (such as birth control pills, injections, implants, skin patches, and vaginal rings) may not be effective enough to prevent pregnancy during your treatment.

Your medication needs may change if you have unusual stress such as a serious illness, fever or infection, or if you have surgery or a medical emergency. Tell your doctor about any such situation that affects you.

Call your doctor at once if you have a serious side effect such as sudden numbness or weakness, problems with vision or speech, chest pain, sudden cough, or wheezing, swelling, rapid weight gain, feeling short of breath, ringing in your ears, dizziness, nausea, pain behind your eyes, stomach pain and loss of appetite, dark urine, or jaundice (yellowing of the skin or eyes).

You should not use this medication if you are allergic to danazol, or if you have:

• severe heart disease;

• severe kidney disease;

• severe liver disease;

• porphyria;

• abnormal vaginal bleeding that has not been checked by a doctor;

• if you are pregnant or breast-feeding a baby.

Before taking danazol, tell your doctor if you are allergic to any drugs, or if you have:

• a history of stroke or blood clot;

• high cholesterol or triglycerides, coronary artery disease;

• breast cancer;

• a seizure disorder;

• heart disease, congestive heart failure;

• kidney or liver disease; or

• migraine headaches.

If you have any of these conditions, you may need a dose adjustment or special tests to safely take danazol.

FDA pregnancy category X. This medication can cause birth defects. Do not use danazol if you are pregnant. Tell your doctor right away if you become pregnant during treatment.

Before you start taking danazol, 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 forms of contraception (such as birth control pills, injections, implants, skin patches, and vaginal rings) may not be effective enough to prevent pregnancy during your treatment.

Taking danazol to treat endometriosis may increase your risk of ovarian cancer. Talk with your doctor about your individual risk.