FDA label 17f863dd-1b47-4f2c-8893-fb06e09250ca

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

SPL set ID
be68c512-7985-47fa-a64b-6bac80bd9751
SPL ID
17f863dd-1b47-4f2c-8893-fb06e09250ca
Version
5
Effective date
2013-12-31
Source export date
2026-10-12
Source partition
1
Source file
https://download.open.fda.gov/drug/label/drug-label-0001-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/7928c8e8c6256620071a8b7e5b93eb8dfa543649c08d17a01ea02251012ba58c/drug-label-0001-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 01:25:45

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 1 matching rows.

warnings

WARNINGS Finasteride is not indicated for use in pediatric patients (see PRECAUTIONS, Pediatric Use) or women (see also WARNINGS, EXPOSURE OF WOMEN — RISK TO MALE FETUS; PRECAUTIONS, Information for Patients and Pregnancy; and HOW SUPPLIED). EXPOSURE OF WOMEN — RISK TO MALE FETUS Women should not handle crushed or broken finasteride tablets USP, 5 mg when they are pregnant or may potentially be pregnant because of the possibility of absorption of finasteride and the subsequent potential risk to a male fetus. Finasteride tablets USP, 5 mg are coated and will prevent contact with the active ingredient during normal handling, provided that the tablets have not been broken or crushed. (See CONTRAINDICATIONS; PRECAUTIONS, Information for Patients and Pregnancy; and HOW SUPPLIED.)

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.