Drug Notebook

FDA Alerts

    Fetotoxicity
  • May cause fetal harm; contraindicated in pregnant women. Pregnancy must be excluded before the start of treatment and prevented thereafter by use of a nonhormonal method of contraception during therapy. (See Fetal/Neonatal Morbidity and Mortality under Cautions.)
    Thrombotic Events
  • Serious and potentially life-threatening thromboembolic events reported. (See Cardiovascular Effects under Cautions.)
    Hepatic Effects
  • 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. (See Hepatic Effects under Cautions.)
  • Administer lowest effective dosage.
  • 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.
    Pseudotumor Cerebri
  • Risk of pseudotumor cerebri (benign intracranial hypertension); manifested by papilledema, headache, nausea and vomiting, and/or visual disturbances.
  • 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.

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danazol
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(DAN a zol)

What is the most important information I should know about danazol?

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).

What is danazol?

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.

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