danazol

Pronunciation: DAN a zol

Brand: Danocrine

Danazol 100 mg-BAR

capsule, yellow, imprinted with barr, 634

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Danazol 200 mg-BAR

capsule, orange, imprinted with barr, 635

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Danazol 50 mg-BAR

capsule, white/yellow, imprinted with barr, 633

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

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

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Danazol can harm an unborn baby or cause vaginal birth defects in a newborn female infant. Do not use if you are pregnant.

You may need to have a negative pregnancy test before starting this treatment.

Use a barrier form of birth control (such as a condom or diaphragm with spermicide). Hormonal contraception (such as birth control pills, injections, implants, skin patches, and vaginal rings) may not be effective enough to prevent pregnancy during your treatment with danazol.

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Your medication needs may change if you become ill, have a fever or infection, or if you have surgery or a medical emergency. Tell your doctor about any such situation that affects you. Do not change your medication dose or schedule without your doctor's advice.

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It may take several weeks before your symptoms improve. Keep using the medication as directed and tell your doctor if your symptoms do not improve or if they get worse during treatment.

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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 (hereditary angioedema).

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

What should I discuss with my healthcare provider before taking danazol?

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

  • severe heart disease, a history of stroke or blood clot;
  • severe kidney disease;
  • severe liver disease;
  • a hormone-related cancer such as breast or uterine cancer;
  • porphyria (a genetic enzyme disorder that causes symptoms affecting the skin or nervous system);
  • abnormal vaginal bleeding that has not been checked by a doctor; or
  • if you are pregnant or breast-feeding.

To make sure you can safely take danazol, tell your doctor if you have any of these other conditions:

  • heart disease, high blood pressure, coronary artery disease, congestive heart failure;
  • high cholesterol or triglycerides;
  • a history of breast cancer;
  • diabetes;
  • hypoparathyroidism, or low levels of calcium in your blood;
  • a seizure disorder;
  • kidney or liver disease; or
  • migraine headaches.
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FDA pregnancy category X. This medication can harm an unborn baby or cause vaginal birth defects in a newborn female infant. Do not use danazol if you are pregnant. Stop taking danazol and tell your doctor right away if you become pregnant during treatment.

You may need to have a negative pregnancy test before starting this treatment.

Use a barrier form of birth control (such as a condom or diaphragm with spermicide). Hormonal contraception (such as birth control pills, injections, implants, skin patches, and vaginal rings) may not be effective enough to prevent pregnancy during your treatment with danazol.

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Danazol can pass into breast milk and may harm a nursing baby. You should not breast-feed while you are using danazol.

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

How should I take danazol?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Women who take danazol to treat endometriosis or fibrocystic breast disease should start the medication during a menstrual period.

Danazol is usually given for 6 to 9 months to treat fibrocystic breast disease or endometriosis. To prevent attacks of hereditary angioedema, you may need to use the medication long-term. Follow your doctor's instructions.

Your doctor may occasionally change your dose to make sure you get the best results.

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Your medication needs may change if you become ill, have a fever or infection, or if you have surgery or a medical emergency. Tell your doctor about any such situation that affects you. Do not change your medication dose or schedule without your doctor's advice.

Use danazol regularly to get the most benefit. Try not to miss any doses. Get your prescription refilled before you run out of medicine completely.

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While using danazol, you may need blood tests at your doctor's office. Visit your doctor regularly.

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It may take several weeks before your symptoms improve. Keep using the medication as directed and tell your doctor if your symptoms do not improve or if they get worse during treatment.

This medication can cause unusual results with certain medical tests. Tell any doctor who treats you that you are using danazol.

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Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

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Call your doctor for instructions if you have missed doses for more than 2 days in a row.

What happens if I overdose?

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Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

An overdose of danazol is not expected to produce life threatening symptoms. However, long term use of high doses can lead to symptoms such as weight gain, increased acne or facial hair, menstrual problems, or breast changes.

What should I avoid while taking danazol?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

What are the possible side effects of danazol?

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Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

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In rare cases, danazol can cause a condition that results in the breakdown of skeletal muscle tissue, leading to kidney failure. Call your doctor right away if you have unexplained muscle pain, tenderness, or weakness especially if you also have fever, unusual tiredness, and dark colored urine.

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Call your doctor at once if you have a serious side effect such as:

  • sudden numbness or weakness (especially on one side of the body), confusion, problems with speech or balance;
  • severe headache, ringing in your ears, dizziness, nausea, vomiting, vision problems, pain behind your eyes;
  • chest pain, sudden cough, wheezing, rapid breathing, coughing up blood;
  • pain, swelling, warmth, or redness in one or both legs;
  • swelling or rapid weight gain, especially in your face and midsection;
  • bloody, black, or tarry stools;
  • cough up blood or vomit that looks like coffee grounds; or
  • upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

  • acne or other skin problems, increased sweating;
  • increased hair growth or hair loss;
  • breast changes;
  • decreased amount of semen released during sex;
  • hoarse or deepened voice, sore throat;
  • flushing (warmth, redness, or tingly feeling);
  • changes in your menstrual periods;
  • unusual vaginal bleeding or spotting;
  • vaginal dryness, discomfort, or itching.

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 other drugs will affect danazol?

Tell your doctor about all other medicines you use, especially:

  • carbamazepine (Carbatrol, Equetro, Tegretol);
  • cyclosporine (Gengraf, Neoral, Sandimmune);
  • insulin or oral diabetes medications;
  • tacrolimus (Prograf);
  • a blood thinner such as warfarin (Coumadin, Jantoven); or
  • cholesterol lowering medicines such as atorvastatin (Lipitor, Caduet), fluvastatin (Lescol), lovastatin (Mevacor, Altoprev, Advicor), pitavastatin (Livalo), pravastatin (Pravachol), rosuvastatin (Crestor), or simvastatin (Zocor, Simcor, Vytorin, Juvisync).

This list is not complete and other drugs may interact with danazol. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about danazol.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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