Danazol is a synthetic steroid derived from ethisterone.

Danazol is used to treat endometriosis.

Danazol is also used to treat attacks of hereditary angioedema (an immune system disorder).

Danazol reduces bradykinin production and could potentially reduce the impact of a bradykinin storm. Bradykinin storms may be responsible for some of the complications experienced by COVID-19 patients.

You should not use danazol if you have: undiagnosed vaginal bleeding, porphyria, severe liver or kidney disease, severe heart problems, or if you have ever had a stroke or blood clot, or cancer of the breast, uterus/cervix, or vagina.

Do not use danazol if you are pregnant. Use effective birth control, and tell your doctor if you become pregnant.

Do not breast-feed while using danazol.

Take danazol exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.

You will need frequent medical tests.

Danazol can affect the results of certain medical tests. Tell any doctor who treats you that you are using this medicine.

Women who take danazol to treat endometriosis should start the medication during a menstrual period.

Danazol is usually given for 3 to 9 months to treat endometriosis. To prevent attacks of hereditary angioedema, you may need to use the medication long-term.

Follow your doctor's dosing instructions very carefully.

Your dose needs may change if you become ill, have a fever or infection, or if you have surgery or a medical emergency. Tell your doctor about any such situation that affects you. Do not change your medication dose or schedule without your doctor's advice.

Store danazol at room temperature away from moisture, heat, and light.

Usual Adult Dose for Endometriosis:

Mild Disease:
-Initial dose: 200 to 400 mg orally per day, given in 2 divided doses
-Maintenance dose: Gradual downward titrations should be performed to maintain amenorrhea.
-Duration of therapy: Up to 9 months

Moderate to Severe Disease or Patients Infertile due to Endometriosis:
-Initial dose: 800 mg orally per day, given in 2 divided doses
-Maintenance dose: Gradual downward titrations should be performed to maintain amenorrhea.
-Duration of therapy: Up to 9 months

Comments:
-Treatment should begin during menstruation, OR appropriate pregnancy tests should be performed prior to starting treatment ensure that the patient is not pregnant while on treatment.
-Treatment should continue uninterrupted 3 to 6 months, but may continue for up to 9 months.
-Treatment may be reinstituted if symptoms recur.

Use: Treatment of endometriosis amenable to hormonal management

Usual Adult Dose for Fibrocystic Breast Disease:

100 to 400 mg orally per day, given in 2 divided doses

Comments:

-Most patients may be treated with simple measures (e.g., padded brassieres, analgesics). Patients requiring treatment with this drug may have symptoms of severe pain and tenderness.
-Patients should be advised that treatment is not innocuous; hormone level alterations and symptom recurrence are very common after discontinuation of treatment.
-This drug is usually effective in decreasing symptoms of fibrocystic breast disease (e.g., nodularity, pain, tenderness); pain and tenderness are typically eliminated in 2 to 3 months, and nodularity is usually eliminated after 4 to 6 months of uninterrupted treatment.
-Approximately 50% of patients will have symptom recurrence within 1 year; treatment may be reinstated in this patient population if necessary.

Use: Treatment of symptomatic fibrocystic breast disease by suppression of ovarian function

Usual Adult Dose for Angioedema:

Initial dose: 200 mg orally 2 to 3 times a day
-After a favorable initial response, continuing doses should be determined by decreasing the dose by 50% or less at intervals of 1 to 3 months (or longer).
-If an attack occurs, the daily dose may be increased by 200 mg.

You should not use danazol if you are allergic to it, or if you have:

• undiagnosed vaginal bleeding;

• severe heart problems;

• a history of stroke or blood clot;

• severe liver or kidney disease;

• porphyria (a genetic enzyme disorder that causes symptoms affecting the skin or nervous system); or

• a history of hormone-related cancer, or cancer of the breast, uterus/cervix, or vagina.

To make sure danazol is safe for you, tell your doctor if you have ever had:

• heart problems;

• high blood pressure;

• liver disease;

• kidney disease;

• epilepsy or other seizure disorder;

• diabetes; or

• migraine headaches.

You may need to have a negative pregnancy test before starting this treatment.

Do not use danazol if you are pregnant. It could harm the unborn baby or cause birth defects. Use effective birth control to prevent pregnancy while you are using this medicine.

Ask your doctor about using a non-hormonal birth control (such as a condom or diaphragm with spermicide) to prevent pregnancy.

Danazol can pass into breast milk and may harm a nursing baby. You should not breast-feed while you are using danazol.

Danazol is not approved for use by anyone younger than 18 years old.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Call your doctor for instructions if you miss more than 2 doses in a row.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from light and excess heat and moisture (not in the bathroom).

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Get emergency medical help if you have signs of an allergic reaction to danazol: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• loss of appetite, stomach pain (upper right side);

• cough with bloody mucus or vomit that looks like coffee grounds;

• jaundice (yellowing of the skin or eyes);

• bloody or tarry stools, dark urine;

• swelling or weight gain;

• a hoarse or deepened voice, sore throat;

• hair loss, or increased hair growth;

• acne or other skin problems;

• unexplained muscle pain, tenderness, or weakness;

• increased pressure inside the skull - severe headaches, ringing in your ears, dizziness, nausea, vision problems, pain behind your eyes; or

• signs of a blood clot - sudden numbness or weakness, problems with vision or speech, swelling or redness in an arm or leg.

Common danazol side effects may include:

• flushing (sudden warmth, redness, or tingly feeling);

• changes in your menstrual periods;

• unusual vaginal bleeding or spotting;

• breast changes;

• sexual problems;

• decreased amount of semen released during sex;

• mood changes, nervousness; or

• vaginal dryness or irritation.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Tell your doctor about all other medicines you use, especially:

• carbamazepine;

• cyclosporine;

• tacrolimus;

• warfarin;

• insulin or oral diabetes medications; or

• cholesterol lowering medicines such as atorvastatin, lovastatin, or simvastatin.

This list is not complete. Other drugs may interact with danazol, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Before having any laboratory test, tell your doctor and the laboratory personnel that you are taking danazol.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.