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What you should know before using

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatrics

Danazol may cause male-like changes in female children and cause premature sexual development in male children. It may also slow or stop growth in any child.

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults. Although there is no specific information comparing use of danazol in the elderly with use in other age groups, danazol has effects similar to androgens (male hormones). Androgens used in older males may increase the risk of developing prostate enlargement or cancer.

Pregnancy Category Explanation
All Trimesters X Studies in animals or pregnant women have demonstrated positive evidence of fetal abnormalities. This drug should not be used in women who are or may become pregnant because the risk clearly outweighs any possible benefit.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug Interactions

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

  • Bupropion

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Blood clotting disorders or
  • Severe liver disease or
  • Tumor caused by too much male hormones or
  • Tumor on the genitals or
  • Unusual bleeding from the vagina—Danazol should not be used when these conditions exist
  • Porphyria—This condition may be made worse
  • Type 2 diabetes mellitus—Danazol may increase blood glucose (sugar) levels
  • Epilepsy or
  • Heart disease or
  • Kidney disease or
  • Migraine headaches—These conditions can be made worse by the fluid retention (keeping too much body water) that can be caused by danazol

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