No black box warning on record for Finasteride

As of the latest FDA labeling reviewed, Finasteride (finasteride) does not carry a black box warning. Standard warnings and precautions still apply — see the full Finasteride medicine page for the complete safety profile.

Other warnings & precautions

Pregnancy Category X — ABSOLUTE CONTRAINDICATION: Finasteride is absolutely contraindicated in pregnant women. DHT is required for normal differentiation of the external male genitalia in the fetus. Even minimal exposure (including via skin contact with crushed tablets or semen from treated men) can cause feminization of male fetuses. Pregnant women must not handle crushed or broken finasteride tablets. Women of childbearing age must ensure they are not pregnant before touching these tablets and that partners use condoms.
PSA Monitoring for Prostate Cancer: Finasteride reduces serum PSA by approximately 50% after 6 months of use. Men on finasteride being evaluated for prostate cancer should have their PSA values doubled for age-appropriate comparison. Any confirmed PSA increase while on finasteride warrants evaluation for prostate cancer.
Post-Finasteride Syndrome: An FDA-mandated label change in 2012 added warnings for persistent sexual dysfunction (libido loss, ED, ejaculatory dysfunction) and depression that may persist after stopping finasteride. The mechanism is unknown. Patients should be counseled about this possibility, though its frequency is debated.
Prostate Cancer Risk: The Prostate Cancer Prevention Trial found finasteride reduced overall prostate cancer incidence by 25% but was associated with a slight increase in high-grade (Gleason ≥7) cancers. Current thinking is this may represent detection bias. Ongoing discussion with urologist is warranted for long-term BPH patients.

Other warnings & precautions

Pregnancy Category X — ABSOLUTE CONTRAINDICATION: Finasteride is absolutely contraindicated in pregnant women. DHT is required for normal differentiation of the external male genitalia in the fetus. Even minimal exposure (including via skin contact with crushed tablets or semen from treated men) can cause feminization of male fetuses. Pregnant women must not handle crushed or broken finasteride tablets. Women of childbearing age must ensure they are not pregnant before touching these tablets and that partners use condoms.

PSA Monitoring for Prostate Cancer: Finasteride reduces serum PSA by approximately 50% after 6 months of use. Men on finasteride being evaluated for prostate cancer should have their PSA values doubled for age-appropriate comparison. Any confirmed PSA increase while on finasteride warrants evaluation for prostate cancer.

Post-Finasteride Syndrome: An FDA-mandated label change in 2012 added warnings for persistent sexual dysfunction (libido loss, ED, ejaculatory dysfunction) and depression that may persist after stopping finasteride. The mechanism is unknown. Patients should be counseled about this possibility, though its frequency is debated.

Prostate Cancer Risk: The Prostate Cancer Prevention Trial found finasteride reduced overall prostate cancer incidence by 25% but was associated with a slight increase in high-grade (Gleason ≥7) cancers. Current thinking is this may represent detection bias. Ongoing discussion with urologist is warranted for long-term BPH patients.

Finasteride Black Box Warning

No black box warning on record for Finasteride

Other warnings & precautions

Finasteride Black Box Warning

No black box warning on record for Finasteride

Other warnings & precautions