Important Safety Information for Finasteride Tablets

Atlas HRT safety summary derived from the FDA-approved Prescribing Information and Patient Information for finasteride tablets, label revised 01/2025. Last reviewed September 11, 2026.

What is finasteride tablets, USP?

Finasteride tablets, USP is a prescription medicine used for the treatment of male pattern hair loss (androgenetic alopecia).

It is not known if Finasteride tablets, USP works for a receding hairline on either side of and above your forehead (temporal area).

Finasteride tablets, USP is not for use by women and children.

Who should not take finasteride tablets, USP?

Do not take finasteride tablets, USP if you:

• are pregnant or may become pregnant.
• Finasteride tablets, USP are coated and will prevent contact with the medicine during handling, as long as the tablets are not broken or crushed. Females who are pregnant or who may become pregnant should not come in contact with broken or crushed Finasteride tablets, USP. If a pregnant woman comes in contact with crushed or broken Finasteride tablets, USP, wash the contact area right away with soap and water. If a woman who is pregnant comes into contact with the active ingredient in Finasteride tablets, USP, a healthcare provider should be consulted.
• If a woman who is pregnant with a male baby swallows or comes in contact with the medicine in finasteride tablets, USP, the male baby may be born with sex organs that are not normal.
• are allergic to any of the ingredients in finasteride tablets, USP.

What should I tell my healthcare provider before taking finasteride tablets, USP?

Before taking finasteride tablets, USP, 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 non- prescription 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.

What are the possible side effects of Finasteride tablets, USP?

decrease in your blood Prostate Specific Antigen (PSA) levels. Finasteride tablets, USP 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 tablets, USP because finasteride tablets, USP 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 tablets, USP. You should also tell your healthcare provider if you have not been taking finasteride tablets, USP 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 tablets, USP.

The most common side effects of finasteride tablets, USP include: decrease in sex drive, trouble getting or keeping an erection, a decrease in the amount of semen.

The following have been reported in general use with finasteride tablets, USP:

breast tenderness and enlargement. Tell your healthcare provider 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.

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 tablets, USP. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.