Danazol Capsule: Uses, Dosage, Side Effects, Precautions and Alternates

Quick overview

Danazol Capsule contains danazol, a synthetic steroid derived from ethisterone. It is used to treat endometriosis and to prevent attacks of hereditary angioedema, a condition causing swelling of the skin, abdomen, face, or airway. It works by lowering hormones that drive the ovaries and by raising a blood protein that helps prevent swelling attacks. This medicine carries important warnings around pregnancy, liver health, and blood clots.

What is Danazol Capsule

Danazol is a man-made steroid medicine related to testosterone. It is used to treat certain hormone-related conditions in women and to prevent attacks of a rare swelling disorder.

Danazol Capsule uses

• Treatment of endometriosis that can be managed with hormone therapy
• Prevention of attacks of hereditary angioedema (a condition causing swelling of the skin, abdomen, face, or airway) in males and females

Benefits of Danazol Capsule

• Helps treat endometriosis
• Can reduce pelvic pain
• May suppress abnormal endometrial tissue growth
• Can be used for fibrocystic breast disease in selected patients
• May help prevent attacks in hereditary angioedema

How Danazol Capsule works

Danazol lowers the hormones that drive the ovaries, which helps shrink endometriosis tissue. For hereditary angioedema, it raises the level of a blood protein (C1 esterase inhibitor) that is missing or low in people with this condition, which helps prevent swelling attacks.

Danazol Capsule dosage

Take this medicine by mouth as a capsule, divided into two or three doses a day depending on your condition. For endometriosis, treatment should begin while you are having your period, so your doctor can be sure you are not pregnant before starting. Food increases how much of the drug your body absorbs, so take your doses consistently with or without food as your doctor instructs. Treatment for endometriosis usually needs to continue without interruption for several months to work properly. For hereditary angioedema, your doctor will adjust your dose over time based on how well it prevents attacks.

Available forms and strengths

• Capsule (50 mg, 100 mg, 200 mg)

Side effects of Danazol Capsule

Common

• Weight gain
• Acne and oily skin
• Mild excess hair growth (hirsutism)
• Fluid retention or swelling
• Hair loss
• Voice changes (hoarseness, sore throat, deepening of pitch)
• Menstrual changes including spotting, irregular periods, or missed periods
• Flushing and sweating
• Vaginal dryness or irritation
• Reduced breast size
• Nervousness and mood changes
• Headache
• Nausea, vomiting, constipation
• Muscle cramps or spasms, joint pain

Serious

• Liver problems including yellowing of skin/eyes (jaundice), liver tumors, or life-threatening internal bleeding from liver masses
• Blood clots, including dangerous clots in the brain, or stroke
• Benign intracranial hypertension (pressure buildup in the brain) causing headache, vision changes, nausea, and vomiting
• Severe allergic skin reactions such as Stevens-Johnson syndrome
• Irreversible voice changes or masculinizing effects such as clitoral enlargement
• Severe mood or mental health changes including depression
• Seizures
• Low or high blood cell counts

Warnings and precautions

• Do not take this medicine if you are or might be pregnant, because it can cause serious harm to a female baby's development.
• This medicine can cause dangerous blood clots, including clots that cause stroke, which can be life-threatening.
• Long-term use can cause liver problems, including rare but serious liver tumors or bleeding inside the liver, which may not cause symptoms until a medical emergency occurs.
• This medicine can cause increased pressure in the brain, with symptoms like headache, nausea, vomiting, and vision changes. Tell your doctor right away if these occur.
• This medicine can change your cholesterol levels in ways that may raise your risk of heart and blood vessel disease.
• Some masculinizing side effects, like voice changes, may not go away even after stopping the medicine.
• Danazol must not be used during pregnancy. It can cause abnormal development of the genitals in a female baby. You should have a pregnancy test before starting treatment and use a non-hormonal method of birth control while taking this medicine.
• Danazol should not be used while breastfeeding.
• This medicine should not be used by people with severely impaired kidney function.
• This medicine should not be used by people with severely impaired liver function. Liver problems, including liver tumors and dangerous internal bleeding, have occurred with long-term use, so your doctor may check your liver function regularly.
• Alcohol is best limited or avoided because both alcohol and danazol can place additional stress on the liver.
• This medicine usually does not directly impair driving, but avoid driving if dizziness or visual symptoms occur.

Storage

• Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]
• Dispense in a well-closed container with a child-resistant closure
• Keep this and all medications out of the reach of children

When to see a doctor

• Get medical help right away if you have symptoms of a stroke or blood clot, such as sudden weakness, vision changes, or severe headache.
• Seek medical care immediately if you get a severe headache with nausea, vomiting, or vision problems, as this could signal dangerous pressure in the brain.
• Contact your doctor if you notice yellowing of your skin or eyes, dark urine, or severe stomach pain, as these can be signs of serious liver problems.
• Tell your doctor right away if you become pregnant while taking this medicine.

Alternatives

• Norethindrone
• Medroxyprogesterone
• Combined hormonal contraceptives