Danocrine is used to treat endometriosis.

Danocrine is also used to treat attacks of hereditary angioedema (an immune system disorder).

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

You should not use Danocrine if you have: undiagnosed vaginal bleeding, porphyria, severe liver or kidney disease, severe heart problems, or if you have ever had a stroke or blood clot, or cancer of the breast, uterus/cervix, or vagina.

Do not use if you are pregnant. Use effective birth control, and tell your doctor if you become pregnant.

Do not breast-feed while using this medicine.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

You will need frequent medical tests.

Danocrine can affect the results of certain medical tests. Tell any doctor who treats you that you are using Danocrine.

Women who take Danocrine to treat endometriosis should start the medication during a menstrual period.

Danocrine is usually given for 3 to 9 months to treat endometriosis. To prevent attacks of hereditary angioedema, you may need to use the medication long-term.

Follow your doctor's dosing instructions very carefully.

Your dose 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.

Store at room temperature away from moisture, heat, and light.

You should not use Danocrine if you are allergic to it, or if you have:

• undiagnosed vaginal bleeding;

• severe heart problems;

• a history of stroke or blood clot;

• severe liver or kidney disease;

• porphyria (a genetic enzyme disorder that causes symptoms affecting the skin or nervous system); or

• a history of hormone-related cancer, or cancer of the breast, uterus/cervix, or vagina.

Tell your doctor if you have ever had:

• heart problems;

• high blood pressure;

• liver disease;

• kidney disease;

• epilepsy or other seizure disorder;

• diabetes; or

• migraine headaches.

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

Do not use Danocrine if you are pregnant. It could harm the unborn baby or cause birth defects. Use effective birth control to prevent pregnancy while you are using this medicine.

Ask your doctor about using a non-hormonal birth control (such as a condom or diaphragm with spermicide) to prevent pregnancy.

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

Danocrine is not approved for use by anyone younger than 18 years old.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Call your doctor for instructions if you miss more than 2 doses in a row.

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

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

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

Danocrine may cause serious side effects. Call your doctor at once if you have:

• loss of appetite, stomach pain (upper right side);

• cough with bloody mucus or vomit that looks like coffee grounds;

• jaundice (yellowing of the skin or eyes);

• bloody or tarry stools, dark urine;

• swelling or weight gain;

• a hoarse or deepened voice, sore throat;

• hair loss, or increased hair growth;

• acne or other skin problems;

• unexplained muscle pain, tenderness, or weakness;

• increased pressure inside the skull--severe headaches, ringing in your ears, dizziness, nausea, vision problems, pain behind your eyes; or

• signs of a blood clot--sudden numbness or weakness, problems with vision or speech, swelling or redness in an arm or leg.

Common side effects of Danocrine may include:

• flushing (sudden warmth, redness, or tingly feeling);

• changes in your menstrual periods;

• unusual vaginal bleeding or spotting;

• breast changes;

• sexual problems;

• decreased amount of semen released during sex;

• mood changes, nervousness; or

• vaginal dryness or irritation.

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.

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

• carbamazepine;

• cyclosporine;

• tacrolimus;

• warfarin;

• insulin or oral diabetes medications; or

• cholesterol lowering medicines such as atorvastatin, lovastatin, or simvastatin.

This list is not complete. Other drugs may affect Danocrine, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.