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Danazol

Warning

This medication must not be used during pregnancy. It may harm an unborn baby. In women of childbearing age, this medication should be started during their menstrual period. If not, then they should have a negative pregnancy test before starting this medication. It is important to prevent pregnancy while using this medication. Consult your doctor for more details and to discuss the use reliable forms of non-hormonal birth control (such as condoms, diaphragm with spermicide) while using this medication. If you become pregnant or think you may be pregnant, tell your doctor right away.

Danazol has rarely caused very serious (possibly fatal) blood clots (such as stroke), liver disease, and increased pressure on the brain (benign intracranial hypertension). Get medical help right away if you have any symptoms of these side effects, including nausea/vomiting that doesn't stop, headache that is severe or doesn't go away, weakness on one side of the body, trouble speaking, vision changes, severe stomach/abdominal pain, dark urine, yellowing eyes/skin, mental/mood changes (such as confusion).

Precautions

Before taking danazol, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: heart/blood vessel disease (such as coronary artery disease, stroke), high blood pressure (hypertension), diabetes, high cholesterol levels, breast cancer, liver disease, kidney disease, seizures, migraine headaches, unusual vaginal bleeding, certain blood disorders (porphyria, polycythemia), prostate cancer.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

This medication may affect the sperm. Consult your doctor for more details.

This medication must not be used during pregnancy. It may harm the unborn baby. If you become pregnant or think you may be pregnant, tell your doctor right away. (See also Warning section.)

It is unknown if this medication passes into breast milk. Because of the possible risk to the infant, breastfeeding is not recommended while using this medication. Consult your doctor before breastfeeding.

Side Effects

See also Warning section.

Weight gain, acne, flushing, sweating, voice changes (hoarseness, change in pitch), abnormal growth of body hair (in women), vaginal dryness/irritation, or decreased breast size may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: swelling hands/ankles/feet, menstrual changes (such as spotting, missed periods), mental/mood changes (such as nervousness, mood swings).

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

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Drug information is selected from data included with permission and copyrighted by First DataBank, Inc. This is a summary and does not contain all possible information about this product. For complete information about this product or your specific health needs, ask your healthcare professional. Always seek the advice of your healthcare professional if you have any questions about this product or your medical condition. This information is not intended as individual medical advice and does not substitute for the knowledge and judgment of your healthcare professional. This information does not contain any assurances that this product is safe, effective or appropriate for you.

This information is intended only for residents of the United States. Products sold under the same brand names in other countries may contain different ingredients.

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Information expires December 2024.