This drug must not be used during pregnancy because its use may result in birth defects. In females, treatment should begin during menstruation. Otherwise, an early pregnancy test is recommended before starting treatment. Use a reliable, non-hormonal birth control method (e.g., diaphragm, condoms) while taking this drug. Consult your doctor for details.

Danazol may rarely cause serious (sometimes fatal) blood clots, liver disease (e.g., peliosis hepatis, hepatic adenoma), and increased pressure on the brain (pseudotumor cerebri, benign intracranial hypertension). Tell your doctor immediately if you have: weakness on one side of the body, slurred speech, vision changes, confusion, sudden stomach/abdominal pain or swelling, dark urine, persistent nausea/vomiting, yellowing eyes/skin, swollen eyes, unusual headache.

This medication is used to treat several conditions, including pelvic pain and infertility due to a uterus condition (endometriosis), breast pain and tenderness due to nodules (fibrocystic breast disease), and swelling of the abdomen/arms/face/airway due to a certain congenital disease (hereditary angioedema).

Danazol is an androgen similar to testosterone. In women, it works by preventing the ovaries from producing certain natural substances (hormones) that can make these conditions worse. In both men and women, it also works on the body's defense system (immune system) to correct the problems related to angioedema.

Take this medication by mouth with food, usually twice daily or as directed by your doctor.

Dosage is based on your medical condition and response to treatment.

Use this medication regularly to get the most benefit from it. To help you remember, take it at the same times each day.

Tell your doctor if your condition persists or worsens after 3 months.

See also Warning section.

Weight gain, flushing, sweating, vaginal dryness/irritation, and decreased breast or testicle size may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: swelling of hands/feet, mental/mood changes (e.g., nervousness, depression).

Women may experience signs of masculinization (male characteristics) from danazol. To prevent these changes from becoming permanent, stop taking this medication and tell your doctor immediately if any of the following occur: hoarseness, deepening voice, sore throat, facial hair growth, new or worsening acne, enlarged clitoris.

Women often stop having regular menstrual periods while taking this medication. Menstrual periods usually return within 90 days of stopping the drug.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before taking danazol, tell your doctor or pharmacist if you are allergic to it; or to testosterone; or if you have any other allergies.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: abnormal vaginal bleeding of unknown cause, liver disease, kidney disease, heart disease, a certain blood disorder (porphyria).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: high cholesterol levels (hypercholesterolemia), breast cancer, prostate cancer, seizure disorder, migraine headaches, diabetes, stroke.

This medication may make you more sensitive to the sun. Avoid prolonged sun exposure, tanning booths, and sunlamps. Use a sunscreen and wear protective clothing when outdoors.

Extreme caution is advised for use in children because they may be more sensitive to the effects of the drug, especially on bone growth and sexual development. Before starting treatment, consult a doctor with experience using this drug in children.

Caution is advised when using this drug in elderly men because they are at increased risk of developing enlarged prostate and prostate cancer with the use of androgen-like drugs.

This medication must not be used during pregnancy. It may harm the unborn baby. If you become pregnant or think you may be pregnant, tell your doctor immediately. (See also Warning section.)

This drug may pass into breast milk and could have undesirable effects on a nursing infant. Therefore, breast-feeding is not recommended while using this drug. Consult your doctor before breast-feeding.

Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: "blood thinners" (e.g., warfarin), carbamazepine, certain statin-type drugs (lovastatin, simvastatin), cyclosporine, tacrolimus.

This medication may interfere with certain laboratory tests (including male hormone blood levels, glucose tolerance), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: yellowing eyes/skin, stomach/abdominal pain or swelling, dark urine.

Do not share this medication with others.

Laboratory and/or medical tests (e.g., liver function tests) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

Store at room temperature away from light and moisture. Different brands require different storage temperatures, so consult your pharmacist for more information. Do not store in the bathroom. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Information last revised October 2008 Copyright(c) 2008 First DataBank, Inc.