Danocrine

(Danazol)

The active ingredient in Danocrine is danazol. It works by suppressing the release of gonadotropins (FSH and LH) from the pituitary gland, which leads to a reduction in estrogen production by the ovaries. Lower estrogen levels cause atrophy of endometrial tissue and reduce the hormonal stimulation that drives conditions like endometriosis and fibrocystic breast disease. Danazol also has weak androgenic activity, which contributes to its overall hormonal suppression effect.

Follow all directions given to you by your doctor and read all documents provided, including the full Prescribing Information, FDA-Approved Product Labeling, Instructions for Use, and Medication Guide before using Danocrine. However, the following is a synopsis of the general guidelines for the use of Danocrine:

• Take Danocrine exactly as prescribed, usually once or twice daily.
• Swallow capsules with water and do not skip doses.
• Your doctor may adjust the dose based on response, the condition being treated, and side effects.
• Use effective birth control while taking Danocrine because it may cause harm to an unborn baby.
• If a dose is missed, take it as soon as possible unless it is almost time for the next dose.

Some mild or common side effects of Danocrine include:

• Weight gain.
• Acne.
• Hair growth or hair loss.
• Reduction in breast size.
• Vaginal bleeding or menstrual irregularities.
• Fluid retention or mild edema.
• Headaches.
• Joint pain.

Some individuals may experience serious side effects while using Danocrine. These side effects may require immediate medical attention. If you experience any of the following, contact your healthcare provider or seek emergency medical help:

• Signs of liver disease, such as jaundice, changes in your cholesterol levels, abdominal pain, or dark urine.
• Severe allergic reaction, hives, or trouble breathing.
• Intracranial hypertension (increased pressure in the skull).
• Blood clots, chest pain, or shortness of breath.
• Unusual bruising or hematologic abnormalities.

These are not all of the possible side effects of Danocrine. You should always seek medical advice from your healthcare provider for any questions or concerns about your medical condition or treatment. Read all patient information, medication guides, or drug information sheets that come with this medication. You can also report adverse effects to the Food and Drug Administration at www.fda.gov/medwatch or 1-800-FDA-1088.

Before starting Danocrine, it is crucial to discuss any existing health conditions with your healthcare provider. You should be sure that your healthcare provider is aware of all your medical conditions, including:

• Liver disease or a history of jaundice.
• High blood pressure or cardiovascular concerns.
• Blood clot risks or a history of thromboembolic disorders.
• Porphyria.
• Breast cancer or estrogen-related cancers.
• Kidney impairment.
• A history of polycythemia.
• Conditions affected by androgenic effects, such as acne or oily skin.

Danocrine should not be used in individuals who:

• Are pregnant or may become pregnant.
• Have severe liver disease.
• Have unexplained vaginal bleeding.
• Have porphyria.
• Are breastfeeding.
• Have an androgen-dependent tumor.
• Current or history of blood clots.

Danocrine may take several weeks to show improvement, depending on whether it is being used for endometriosis, hereditary angioedema, or fibrocystic breast disease. Continued follow-up is often needed to check progress.

When Danocrine is taken with other prescription drugs, over-the-counter medications, vitamins, and supplements, it may change how they work or increase the frequency or severity of side effects. Make sure that you tell your healthcare professional about anything that you are taking to avoid any negative drug interactions, including:

• Warfarin, because Danocrine may increase the effects of anticoagulants.
• Cyclosporine and tacrolimus, because Danocrine may raise levels of these medicines.
• Statins such as simvastatin, atorvastatin, and lovastatin, because of an increased risk of muscle-related adverse effects.
• Carbamazepine, because enzyme changes may alter Danocrine levels.

Danocrine is available in the following dosage forms and strengths: 50 mg, 100 mg, and 200 mg oral capsules.

It should be stored at room temperature, away from the reach of children or pets.

Danocrine is manufactured by Sanofi‑Aventis.

Yes. Danocrine is available as a generic.

Do not stop taking Danocrine without talking to your healthcare provider. If treatment needs to end, your doctor will guide you based on your condition and symptoms.

Danocrine should not be used during pregnancy due to the risk to the developing fetus. If you can become pregnant, you should use a non-hormonal method of contraception during therapy. If you become pregnant while taking Danocrine, stop the medication and contact your provider immediately.

Danocrine should not be used while breastfeeding because it may affect breast milk and the infant. Talk to your doctor about safe ways to feed your baby while taking Danocrine.