Danazol, Oral

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KEY POINTS

• This medicine is taken by mouth to treat conditions such as endometriosis, fibrocystic breast disease, and hereditary angioedema. Take it exactly as directed.
• Do not become pregnant while you are taking this medicine.
• Keep all appointments for tests to see how this medicine affects you.
• This medicine may cause blood clots, stroke, liver problems, or other unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: gonadotropin inhibitor; anabolic steroid

Generic and brand names: danazol, oral

What is this medicine used for?

This medicine is taken by mouth to treat conditions such as endometriosis, fibrocystic breast disease, and hereditary angioedema (swelling of various parts of the body).

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have:

• An allergy to any medicine
• A stroke or transient ischemic attack (TIA)
• Bleeding problems such as hemophilia or abnormal vaginal bleeding
• Blood clots
• Breast cancer or cancer of the uterus
• Diabetes
• Heart problems
• High cholesterol
• High blood pressure
• Liver or kidney disease
• Migraine headaches or headaches along with vomiting, double vision, unsteadiness, weakness, or personality changes
• Porphyria (nerve pain or sensitivity to sunlight)
• Seizures

Females of childbearing age: Do not become pregnant while you are taking this medicine. Talk to your healthcare provider if you need birth control. Use a nonhormonal form of birth control such as a condom, diaphragm or sponge while taking this medicine. This medicine has been reported to cause birth defects. Stop taking this medicine at the first sign that you may be pregnant and contact your healthcare provider right away. Do not breast-feed while you are taking this medicine.

How do I take it?

Check the label on the medicine for directions about your specific dose. Take this medicine exactly as your healthcare provider prescribes. Do not take more or less or take it longer than prescribed. Do not stop taking this medicine without your healthcare provider's approval.

Check with your healthcare provider before using this medicine in children under 18.

What if I miss a dose?

If you miss a dose, take it as soon as you remember unless it is almost time for the next scheduled dose. In that case, skip the missed dose and take the next one as directed. Do not take double doses. If you are not sure of what to do if you miss a dose, or if you miss more than one dose, contact your healthcare provider.

What if I overdose?

Symptoms of an acute overdose have not been reported.

What should I watch out for?

If you think that you are pregnant, stop taking this medicine and contact your provider right away.

This medicine may cause blood clots and stroke. Contact your healthcare provider right away if you have confusion, sudden loss of feeling on one side of your body, or problems with your speech or balance; trouble breathing; pain, swelling, or warmth in one or both legs.

This medicine can cause increased pressure in the brain. Contact your provider right away if you experience severe headaches, nausea, vomiting, and vision problems.

This medicine can cause liver problems. Contact your healthcare provider right away if you have dark urine, light-colored bowel movements, upper stomach pain, loss of appetite, vomiting, or yellowing of your skin or eyes.

Your healthcare provider may want to see you regularly to check your progress.

You will need to have blood tests regularly to see how this medicine affects you. Keep all appointments for these tests. Women taking this medicine may have irregular menstrual periods. Check with your healthcare provider if they continue.

This medicine may make your skin more sensitive to the sun, which may lead to painful sunburns. While you are taking this medicine, avoid long exposure to the sun. Wear protective clothing, a hat, and sunscreen lotion when you need to be outdoors. Do not use a sunlamp or tanning bed. If you get a severe sunburn, contact your healthcare provider right away.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine.

If you have diabetes: This medicine may affect your blood sugar level and change the amount of insulin or other diabetes medicines you may need. Talk to your healthcare provider about this.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; tightness in your chest; swelling of your lips, tongue, and throat); sudden weakness, numbness, or tingling, especially on one side of your body; sudden or severe headache; sudden trouble with vision, speech, balance, or walking.

Serious (Report these to your healthcare provider right away.): Muscle pain; weakness; yellowing of your skin or eyes; severe nausea and vomiting; vision changes; unusual bruising or bleeding; trouble breathing; pain, swelling, or warmth in one or both legs.

Other: Sweating, mood changes, acne, oily skin, flushing, deepening of your voice, unwanted hair growth, nausea, constipation, headache, vaginal irritation or dryness, menstrual changes, dizziness.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• Calcitriol (Rocaltrol)
• Carbamazepine (Carbatrol, Epitol, Equetro, Tegretol)
• Cholesterol-lowering medicines such as atorvastatin (Lipitor), fluvastatin (Lescol), lovastatin (Altoprev), pravastatin (Pravachol), rosuvastatin (Crestor), and simvastatin (Zocor)
• Diabetes medicines such as acarbose (Precose), glimepiride (Amaryl), glipizide (Glucotrol), glyburide (Glynase), insulin, metformin (Fortamet, Glucophage, Riomet), miglitol (Glyset), nateglinide (Starlix), pioglitazone (Actos), repaglinide (Prandin), rosiglitazone (Avandia), and sitagliptin (Januvia)
• Hormonal birth control pills, implants, shots, patches, vaginal rings, and IUDs, and hormones such as conjugated estrogens (Premarin), estradiol (Climara, Estrace, Estraderm, Vivelle), medroxyprogesterone (Depo-Provera, Provera), and norethindrone (Aygestin, Micronor)
• Immunosuppressants such as cyclosporine (Gengraf, Neoral, Sandimmune), sirolimus (Rapamune), and tacrolimus (Astagraf, Prograf, Protopic)
• Pimozide (Orap)
• Ranolazine (Ranexa)
• Red yeast rice
• Warfarin (Coumadin)

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine at room temperature. Keep the container tightly closed. Protect it from heat, high humidity, and bright light.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicine in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.