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Risks and Side Effects
Who should NOT take AVODART?
- Do not take AVODART if you have had an allergic reaction to AVODART or any of its ingredients.
- Do not take AVODART if you have previously demonstrated, clinically significant hypersensitivity (eg, serious skin reactions, angioedema) to AVODART or other 5α-reductase inhibitors.
What are the special precautions about AVODART?
- Patients should be assessed to rule out prostate cancer and other urological diseases prior to treatment with AVODART and periodically thereafter.
- Men treated with AVODART should not donate blood until at least 6 months after their final dose to prevent giving AVODART to a pregnant female through a blood transfusion.
- Tell your doctor if you have liver problems. AVODART may not be right for you.
What are the possible side effects of AVODART?
- Possible side effects are impotence (trouble getting or keeping an erection), a decrease in libido (sex drive), enlarged breasts, a decrease in the amount of semen released during sex, and allergic reactions such as rash, itching, hives, and swelling of the lips or face. These events occurred infrequently.
Talk with your doctor if you have questions about these and other side effects that you think may be related to taking AVODART.
What are the special warnings for women about AVODART?
- Women should never take AVODART.
- Women who are pregnant or may become pregnant should not handle AVODART Capsules. If a woman who is pregnant with a male baby gets enough AVODART into her body after swallowing it or through her skin after handling it, the male baby may be born with abnormal sex organs.
Patients should not donate blood until 6 months after their last dose.
Indication and Important Safety Information About AVODART® (dutasteride)
AVODART alone and in combination with the alpha blocker tamsulosin is indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to improve symptoms. AVODART alone also reduces the risk of acute urinary retention (AUR) and prostate surgery. AUR is a condition, possibly requiring surgery, where the prostate is so enlarged that it completely blocks urine coming from the bladder.
Only your health care provider can tell if your symptoms are from BPH and not a more serious condition, such as prostate cancer. See your doctor for regular exams.
Women and children should not take AVODART. Women who are or could become pregnant should not handle AVODART due to the potential risk of a specific birth defect.
Do not donate blood until at least 6 months after stopping AVODART.
Tell your doctor if you have liver disease. AVODART may not be right for you.
Possible side effects, including sexual side effects and swelling or tenderness of the breast, occur infrequently. Dizziness and an increase in drug-related ejaculation disorders also occurred with combination therapy (AVODART and tamsulosin).
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 Soft Gelatin Capsules, 0.5 mg.
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