Important Safety Information About AVODART

AVODART is for adult men only. Women should not take or touch AVODART due to risk of a specific birth defect. If a woman comes in contact with leaking AVODART Capsules, she should wash the contact area immediately with soap and water.

Do not take AVODART if you are allergic to dutasteride, finasteride, or any of the ingredients in AVODART.

AVODART may cause rare and serious allergic reactions, including swelling of your face, tongue, or throat, and serious skin reactions, such as skin peeling. Get medical help right away if you have these serious allergic reactions.

Your healthcare provider may check you for other prostate problems, including prostate cancer, before you start and while you take AVODART. A blood test called PSA (prostate-specific antigen) is sometimes used to see if you might have prostate cancer. AVODART will reduce the amount of PSA measured in your blood. Your healthcare provider is aware of this effect and can still use PSA to see if you might have prostate cancer. Increases in your PSA levels while on treatment with AVODART (even if the PSA levels are in the normal range) should be evaluated by your healthcare provider.

AVODART may cause serious side effects including a higher chance of a more serious form of prostate cancer.

Only your healthcare provider can tell if your symptoms are due to BPH or a more serious condition like prostate cancer. See your doctor for regular exams.

Do not donate blood until at least 6 months after stopping AVODART.

The most common side effects of AVODART include trouble getting or keeping an erection (impotence), a decrease in sex drive (libido), ejaculation problems and enlarged or painful breasts. Dizziness and an increase in drug-related ejaculation disorders also occurred with combination therapy (AVODART and tamsulosin).

Some types of medicines should be used with caution when taken with AVODART, such as ritonavir.

Before you take AVODART, tell your doctor if you have liver disease.

While some men have fewer problems and symptoms after 3 months of treatment with AVODART, a treatment period of at least 6 months is usually necessary to see if AVODART will work for you.

Click here for complete Prescribing Information for AVODART.

Complete Prescribing Information for AVODART is provided in Adobe's Portable Document Format (PDF). To view these documents you will need Adobe Acrobat Reader; if you do not have it, follow the link to download a copy.

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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.