Important safety information for finasteride:
Finasteride is for use by MEN ONLY and should NOT be used by women or children.
Read this Important Safety Information before you start taking finasteride and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or treatment.
What should I tell my healthcare provider before taking finasteride?
Before taking finasteride, tell your healthcare provider if you:
have any other medical conditions, including problems with your prostate or liver
Tell your healthcare provider about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.
Who should not take finasteride?
Do not take finasteride if you have ever had an allergic reaction to any of its ingredients. Finasteride should not be used by women who are or may be pregnant or those who may become pregnant, and therefore is typically not prescribed to pre-menopausal women. It also should not be used while breastfeeding. Finasteride is not recommended for use in infants or children. If you have a history of liver disease, you should not use finasteride. Finasteride can affect the levels of a substance called PSA in your bloodstream, which is used as a marker to detect or monitor prostate cancer. Therefore you should tell your healthcare provider if you are taking this medication, especially if you have a history of prostate cancer. If you have a history of benign prostatic hyperplasia (BPH) with intermittent urinary tract obstruction, a healthcare provider may monitor you closely if you are being treated with this medication.
Finasteride and a dietary supplement known as Saw Palmetto (Serenoa repens) both have similar effects in the body (and may both be recommended for use in people with benign prostatic hyperplasia BPH), so their effects may be compounded when used together. Before starting treatment with finasteride, let your healthcare provider know about any medications or supplements you’re taking.
What are the possible side effects of finasteride?
decrease in your blood Prostate Specific Antigen (PSA) levels. Finasteride 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 healthcare provider that you are taking finasteride because finasteride decreases PSA levels. Changes in PSA levels will need to be evaluated by your healthcare 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 finasteride. You should also tell your healthcare provider if you have not been taking finasteride as prescribed because this may affect the PSA test results. For more information, talk to your healthcare 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 finasteride.
The most common side effects of finasteride include:
Finasteride serious side effects
Serious side effects from finasteride when taken as directed are typically rare. There is some evidence that finasteride can increase the risk of breast cancer. It can also cause angioedema (a reaction that causes swelling in the face, eyes, and throat). Women who are pregnant, nursing, or may become pregnant should not use finasteride or come in contact with broken or crushed finasteride tablets. When used during pregnancy it can cause significant harm to the developing fetus.
The following have been reported in general use with finasteride:
breast tenderness and enlargement. Tell your healthcare provider about any changes in your breasts such as lumps, pain or nipple discharge.
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;
difficulty in achieving an erection that continued after stopping the medication;
male infertility and/or poor quality of semen.
in rare cases, male breast cancer.
Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of finasteride. For more information, ask your healthcare provider or pharmacist.
Finasteride may affect your ability to get or maintain an erection (erectile dysfunction). It can also affect your libido or reduce the volume of your ejaculation. There are some reports of testicular pain when using finasteride. When using this medication, let your healthcare provider know if you are experiencing new-onset or worsening depression.
Women who are pregnant, nursing, or may become pregnant should not use finasteride and should not touch broken tablets. When used during pregnancy, finasteride can cause significant harm to the developing fetus.
If you are experiencing a medical emergency, call 911 or seek immediate medical attention.
Withholding or providing inaccurate information about your health and medical history in order to obtain treatment may result in harm, including, in some cases, death.
You are encouraged to report negative side effects of prescription products to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Please see the full Prescribing Information for complete safety information.