When This Medicine Should Not Be Used:
This medicine is not right for everyone. Do not use it if you have had an allergic reaction to danazol, or if you have severe liver disease, kidney disease, heart disease, a history of blood clotting problems, a tumor that is sensitive to androgen (male hormone), or porphyria. Do not use this medicine if you are pregnant or breastfeeding, or if you have unusual vaginal bleeding that has not been checked by your doctor.

How to Use This Medicine:
Capsule

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
• You should start taking this medicine while you are having your monthly period.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:
Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how danazol works. Tell your doctor if you are also using any of the following:
  
  • Carbamazepine
  • Cyclosporine
  • Tacrolimus
  • Insulin or diabetes medicine that you take by mouth
  • Medicine to lower cholesterol
  • A blood thinner, such as warfarin

Warnings While Using This Medicine:

• It is not safe to take this medicine during pregnancy. It could harm an unborn baby. Tell your doctor right away if you become pregnant. You should use birth control that does not have hormones while you take this medicine.
• Make sure your doctor knows if you have a blood disease, diabetes, epilepsy, high blood pressure, kidney or heart problems, or migraines.
• This medicine may cause the following problems:
  
  • Irregular or absent monthly periods
  • Benign intracranial hypertension
  • Changes in blood sugar levels
  • Deep or husky voice, unusual hair growth, or weight gain (in women)
• Tell any doctor or dentist who treats you that you are using this medicine. This medicine may affect certain medical test results.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:
Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blistering, peeling, red skin rash
• Chest pain, trouble breathing
• Dark urine or pale stools
• Headache or changes in vision
• Nausea, vomiting, loss of appetite, pain in your upper stomach, yellow skin or eyes
• Numbness or weakness in your arm or leg, or on one side of your body
• Swelling of the face, hands, arms, legs, or feet

If you notice these less serious side effects, talk with your doctor:

• Acne, oily skin, deep or husky voice, or unusual hair growth
• Weight gain

If you notice other side effects that you think are caused by this medicine, tell your doctor.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088