Drugs A - Z

Danazol Oral capsule

It is used in women to treat endometriosis and the symptoms of fibrocystic breast disease

Generic Name: danazol

Brand Names: Danocrine

There is an FDA Alert for this drug. Click here to view it.

    Fetotoxicity
  • May cause fetal harm; contraindicated in pregnant women. Pregnancy must be excluded before the start of treatment and prevented thereafter by use of a nonhormonal method of contraception during therapy. (See Fetal/Neonatal Morbidity and Mortality under Cautions.)
    Thrombotic Events
  • Serious and potentially life-threatening thromboembolic events reported. (See Cardiovascular Effects under Cautions.)
    Hepatic Effects
  • Serious and potentially life-threatening hepatic effects (e.g., peliosis hepatis and benign hepatic adenoma resulting in intra-abdominal hemorrhage) reported with long-term therapy. (See Hepatic Effects under Cautions.)
  • Administer lowest effective dosage.
  • If therapy initiated at time of exacerbation of hereditary angioedema due to trauma, stress, or other causes, periodically attempt to decrease dosage or withdraw therapy.
    Pseudotumor Cerebri
  • Risk of pseudotumor cerebri (benign intracranial hypertension); manifested by papilledema, headache, nausea and vomiting, and/or visual disturbances.
  • If signs and symptoms of pseudotumor cerebri occur, examine for the presence of papilledema; if present, discontinue danazol immediately and refer patient to a neurologist for further evaluation and care.

What is this medicine?

DANAZOL (DA na zole) is used in women to treat endometriosis and the symptoms of fibrocystic breast disease. This medicine may also be used in men and women to prevent serious allergic reactions known as angioedema.

What should I tell my health care provider before I take this medicine?

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 medicines, foods, dyes, or preservatives
  • pregnant or trying to get pregnant
  • breast-feeding

How should I use this medicine?

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

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

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 medicine?

Do not take this medicine with any of the following medications:
  • cisapride
  • pimozide
  • ranolazine

This medicine may also interact with the following medications:

  • carbamazepine
  • medicines that treat or prevent blood clots like warfarin

What should I watch for while using this medicine?

Check with your doctor or health care professional if you are a female patient and notice any changes in your voice, decrease in breast size, or if hair starts growing on your face.

This medicine should not be used in pregnancy. You should use a non-hormonal form of birth control while on this medicine. If you become pregnant or think you may be pregnant while you are taking this medicine, you should stop taking this medicine and contact your doctor or health care professional. This medicine may cause risk to a female fetus.

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

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:
  • allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
  • changes in vision
  • dark urine
  • decrease in breast size
  • hair loss or unusual hair growth
  • headache
  • irregular vaginal bleeding, spotting
  • nausea, vomiting, stomach pain
  • redness, blistering, peeling or loosening of the skin, including inside the mouth
  • unusual bleeding or bruising
  • unusual swelling of feet or ankles
  • unusually weak or tired
  • voice changes
  • weight gain
  • yellowing of the skin or eyes

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

  • acne, oily skin
  • hot flashes, sweating
  • mood changes
  • vaginal dryness or irritation

Where should I keep my medicine?

Keep out of the reach of children.

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

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.


Last Updated: April 09, 2009
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