Danocrine

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 other reasons not mentioned in this medication guide.

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

You will need regular medical tests.

Danocrine can affect the results of some medical tests. Inform any doctor who treats you that you are taking Danocrine.

Women using Danocrine to treat endometriosis should start the medication during their menstrual period.

Danocrine is typically taken for 3 to 9 months to treat endometriosis. To prevent attacks of hereditary angioedema, you may need to take the medication for a longer period.

Follow your doctor's dosing instructions very closely.

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

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

You should not take 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 inform your doctor if you become pregnant.

Do not breast-feed while taking this medicine.

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.

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 right away 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.

Take the medicine as soon as possible, but skip the missed dose if it is nearly time for your next dose. Do not take two doses at once.

Contact your doctor for guidance 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.

Tell your doctor about all other medicines you are taking, 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.