Danazol Capsules

What is this medication?

DANAZOL (DA na zole) treats the symptoms of endometriosis. It may also be used to relieve breast pain caused by fibrocystic breast disease. It works by decreasing the amount of estrogen and other hormones your body makes. It can also be used to prevent episodes of swelling in people with hereditary angioedema. It works by helping your immune system prevent inflammation. It belongs to a group of medications called androgen hormones.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Danocrine

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Breast cancer
• Heart disease
• Kidney disease
• Liver disease
• Porphyria
• Unusual vaginal bleeding
• An unusual or allergic reaction to danazol, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

How should I use this medication?

Take this medication by mouth with a glass of water. Follow the directions on the prescription label. Take this medication with food to decrease stomach upset. Take your doses at regular intervals. Do not take your medication more often than directed.

Talk to your care team about the use of this medication in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medication?

Do not take this medication with any of the following:

• Cisapride
• Pimozide
• Ranolazine

This medication may also interact with the following:

• Carbamazepine
• Medications that treat or prevent blood clots, such as warfarin

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Talk to your care team if you wish to become pregnant or think you might be pregnant. This medication can cause serious birth defects if taken during pregnancy. A barrier contraceptive, such as a condom or diaphragm, is recommended during treatment.

This medication can affect your menstrual cycle. You may stop having menstrual periods. These will return to normal within 2 to 3 months after you stop taking this medication.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Blood clot—pain, swelling, or warmth in the leg, shortness of breath, chest pain
• Increased pressure around the brain—severe headache, blurry vision, change in vision, nausea, vomiting
• Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue
• Stroke—sudden numbness or weakness of the face, arm, or leg, trouble speaking, confusion, trouble walking, loss of balance or coordination, dizziness, severe headache, change in vision
• Swelling of the ankles, hands, or feet

Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome):

• Acne
• Hot flashes
• Irregular menstrual cycles or spotting
• Mood swings, irritability, hostility
• Unexpected hair growth
• Weight gain

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children and pets.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Throw away any unused medication after the expiration date.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.