Available as PDF Downloads.
Important Risk Information About PROPECIA
Women who are or may be pregnant must not use PROPECIA and should not handle crushed or broken PROPECIA tablets because the active ingredient may cause abnormalities of a male baby’s sex organs. If a woman who is pregnant comes into contact with the active ingredient in PROPECIA, a doctor should be consulted. PROPECIA tablets are coated and will prevent contact with the active ingredient during normal handling provided that the tablets are not broken or crushed.
You should not use PROPECIA if you are allergic to finasteride or any of the ingredients of PROPECIA.
In clinical studies for PROPECIA, a small number of men experienced certain sexual side effects, such as less desire for sex, difficulty in achieving an erection, or a decrease in the amount of semen. Each of these side effects occurred in less than 2% of men and went away in men who stopped taking PROPECIA because of them.
In general use, the following have been reported: breast tenderness and enlargement (tell your doctor about any changes in your breasts such as lumps, pain, or nipple discharge); depression; decrease in sex drive that continued after stopping the medication; allergic reactions including rash, itching, hives, and swelling of the lips, tongue, throat, and face; problems with ejaculation that continued after stopping medication; testicular pain; difficulty in achieving an erection that continued after stopping the medication; male infertility and/or poor quality of semen; and, in rare cases, male breast cancer. Tell your doctor if you have any side effect that bothers you or that does not go away.
PROPECIA can affect a blood test called PSA (Prostate-Specific Antigen) for the screening of prostate cancer. If you have a PSA test done, you should tell your health care provider that you are taking PROPECIA because PROPECIA decreases PSA levels. Changes in PSA levels will need to be evaluated by your health care provider. Any increase in follow-up PSA levels from their lowest point may signal the presence of prostate cancer and should be evaluated, even if the test results are still within the normal range for men not taking PROPECIA. You should also tell your health care provider if you have not been taking PROPECIA as prescribed because this may affect the PSA test results. For more information, talk to your health care provider. There may be an increased risk of a more serious form of prostate cancer in men taking finasteride at 5 times the dose of PROPECIA.
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.
This site is intended only for residents of the United States, its territories, and Puerto Rico.
Know the facts. PROPECIA is available by prescription only, so the best thing to do is talk with your doctor.
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. PROPECIA is a registered trademark of Merck Sharp & Dohme Corp. a subsidiary of Merck & Co., Inc.