Finasteride Tablets | Commercial
Important Safety Information: Finasteride Tablets | Commercial
Finasteride 1 mg is an FDA-approved oral medication used to treat male pattern hair loss in adult men. If you’ve started noticing a receding hairline, thinning at the crown, or gradual overall hair thinning, this medication is designed to address one of the root causes. Finasteride works by lowering levels of DHT, a hormone that can shrink hair follicles in men who are genetically prone to hair loss. By reducing DHT, it may help slow further thinning and support visible hair regrowth over time.
Most men need to take finasteride daily for at least three months before seeing noticeable improvement. Consistency matters, and continued use is required to maintain results. If you stop taking the medication, the benefits gained during treatment are typically lost within about 12 months.
This medication is an FDA-approved commercial product indicated for men only and is not approved for use in women or children dispensed by a licensed pharmacy. Review important medication safety information.
What is this?
This Important Safety Information summarizes key warnings and precautions for Finasteride Tablets, USP 1 mg, an oral 5α-reductase inhibitor indicated for the treatment of male pattern hair loss (androgenetic alopecia) in men only. Finasteride works by reducing levels of dihydrotestosterone (DHT), a hormone linked to hair loss in genetically predisposed men.
Finasteride is not indicated for use in women or pediatric patients. This summary does not include all available information. Always read your medication label and follow your provider’s instructions. For full prescribing details, refer to the FDA-approved labeling .
Most Serious Warnings
Product can cause:
Decrease in Prostate-Specific Antigen (PSA) levels, which may affect prostate cancer screening results
Increased risk of high-grade prostate cancer reported with 5α-reductase inhibitors
Severe allergic reactions, including rash, itching, hives, and swelling of the lips, tongue, throat, or face
Persistent sexual dysfunction, including erectile dysfunction, decreased libido, or ejaculation disorders
Depression, including reports of suicidal thoughts or behavior
Breast changes, including tenderness, enlargement, lumps, or in rare cases, male breast cancer
Women who are pregnant or may become pregnant must not handle crushed or broken tablets due to risk of harm to a male fetus .
Who Should NOT Take Finasteride
Do not take this medication if you:
Are pregnant or may become pregnant
Are allergic to finasteride or any ingredient in the formulation
Are a woman or a child
Finasteride 1 mg is indicated for men only .
Before Taking Finasteride, Tell Your Healthcare Provider if You:
Have liver disease or abnormal liver function
Have prostate conditions or are undergoing PSA testing
Have a history of depression or mood disorders
Have a history of infertility or concerns about semen quality
Notice breast changes such as lumps, pain, or discharge
Take prescription, over-the-counter, or herbal medications
Finasteride may lower PSA levels by approximately 50 percent. Any increase in PSA while taking finasteride should be evaluated by a healthcare provider .
Possible Side Effects
Common (reported in 1 percent or more of patients)
Decreased sex drive
Erectile dysfunction
Ejaculation disorder, including decreased semen volume
Serious (seek medical care immediately)
Swelling of the face, lips, tongue, or throat
Difficulty breathing
Severe rash or hives
Breast lumps, nipple discharge, or persistent breast pain
Severe mood changes, depression, or suicidal thoughts
Sexual side effects have been reported to continue after discontinuation in some individuals .
While Taking Finasteride
Tell your healthcare provider immediately if you:
Notice changes in breast tissue
Experience persistent sexual dysfunction
Develop depressive symptoms or mood changes
Have significant changes in PSA levels
Daily use for at least three months is generally required before benefit is observed. Continued use is recommended to maintain results. Stopping treatment typically results in reversal of benefit within 12 months .
Pregnancy Warning
Finasteride is contraindicated in women who are or may become pregnant. Exposure during pregnancy may cause abnormalities of the external genitalia in a male fetus. Tablets are coated to prevent contact during normal handling, but crushed or broken tablets should not be handled by pregnant women .
Overdose
In clinical studies, doses up to 400 mg as a single dose and 80 mg daily for three months did not result in serious adverse reactions. If overdose is suspected, seek medical attention immediately .
Missed Dose
If you miss a dose:
Take the next scheduled dose as directed
Do not take extra tablets
Do not take more than one tablet daily
Storage
Store at 20°C to 25°C (68°F to 77°F)
Keep in a tightly closed, light-resistant container
Protect from moisture
Keep out of reach of children .
Telemedicine Disclosure
This prescription may be issued via telemedicine. If you experience severe or concerning symptoms, contact your prescribing clinician immediately or seek emergency medical care.
Disclaimer
This summary does not include all information about Finasteride Tablets, USP 1 mg and should not replace medical guidance. Always consult your healthcare provider or pharmacist for complete safety information, potential interactions, and individualized treatment recommendations.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit MedWatch or call 1-800-FDA-1088.
