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Medications and Drugs

Brand Names: Danocrine

Generic Name: danazol (Pronunciation: DAN a zol)

What is danazol (Danocrine)?

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.

Danazol 100 mg-BAR

capsule, yellow, imprinted with barr, 634

Danazol 200 mg-BAR

capsule, orange, imprinted with barr, 635

Danazol 50 mg-BAR

capsule, white/yellow, imprinted with barr, 633

What are the possible side effects of danazol (Danocrine)?

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.

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.

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 is the most important information I should know about danazol (Danocrine)?

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.

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.

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.

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.

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).



Report Problems to the Food and Drug Administration

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

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