Danazol Oral Capsule (DANAZOL - ORAL)

Instructions

This medicine may be taken with or without food, but it is important to take it the same way each time.

This medicine will work best if you take it at about the same time every day.

Store at room temperature away from heat, light, and moisture. Do not keep in the bathroom.

Do not store above 77 degrees F (25 degrees C).

If you forget to take a dose on time, take it as soon as you remember. If it is almost time for the next dose, do not take the missed dose. Return to your normal schedule. Do not take 2 doses at one time.

Drug interactions can change how medicines work or increase risk for side effects. Tell your health care providers about all medicines taken. Include prescription and over-the-counter medicines, vitamins, and herbal medicines. Speak with your doctor or pharmacist before starting or stopping any medicine.

Tell your doctor if symptoms do not get better or if they get worse.

Keep all appointments for medical exams and tests while on this medicine.

Cautions

Tell your doctor and pharmacist if you ever had an allergic reaction to a medicine.

Some patients taking this medicine have experienced serious side effects. Please speak with your doctor to understand the risks and benefits associated with this medicine.

This medicine is associated with a rare, but serious problem of the liver. Speak to your doctor about the early signs of liver problems and the benefits and risks of using this medicine.

This medicine is associated with an increased risk for serious blood clots. Speak with your doctor about the benefits and risks from using this medicine.

Do not use the medication any more than instructed.

Call the doctor if there are any signs of confusion or unusual changes in behavior.

Do not breastfeed while on this medicine.

Do not use this medicine if you are pregnant. If you become pregnant, contact your doctor immediately.

This medicine can cause birth defects. Speak with your doctor about birth control methods that should be used while on this medicine.

Women of childbearing age should have a negative pregnancy test before starting this medicine.

Do not share this medicine with anyone who has not been prescribed this medicine.

Side Effects

The following is a list of some common side effects from this medicine. Please speak with your doctor about what you should do if you experience these or other side effects.

• acne
• feeling of heat or flushing
• unusual facial or body hair growth in women
• unusual or long-lasting hoarseness
• sweating
• vaginal dryness or irritation
• weight gain

Call your doctor or get medical help right away if you notice any of these more serious side effects:

• swelling of the legs, feet, and hands
• severe or persistent headache
• signs of liver damage (such as yellowing of eye or skin, dark urine, or unusual tiredness)
• menstruation changes (missed or fewer periods)
• mood changes
• symptoms of stroke (such as one-sided weakness, slurred speech, confusion)
• sudden change or loss of vision

A few people may have an allergic reaction to this medicine. Symptoms can include difficulty breathing, skin rash, itching, swelling, or severe dizziness. If you notice any of these symptoms, seek medical help quickly.