Finasteride (Propecia) drug label

Patient Information – April 2012

After Propecia was approved in 1997, the FDA required several updates to the label. In 2012, the label was revised to include reports of sexual adverse effects “that continued after stopping the medication”. Here are adverse effects from the current label, with underlining added for emphasis:

The most common side effects of PROPECIA 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 PROPECIA [emphasis added]:

• 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 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.

Note: In June 2022, FDA required a new adverse reaction to be added to Prescribing Information (below): suicidal ideation and behavior. It does not appear in Patient Information. For background, see a Reuters story and this post.

View original document (PDF). See also: A history of changes to the Propecia label


Highlights of Prescribing Information – August 2022

View original document (PDF)

Excerpt from Section 6: Adverse Reactions (p. 3) with emphasis added:

6 ADVERSE REACTIONS

6.1 Clinical Trials Experience

[…]

Clinical Studies for PROPECIA (finasteride 1 mg) in the Treatment of Male Pattern Hair Loss

In three controlled clinical trials for PROPECIA of 12-month duration, 1.4% of patients taking PROPECIA (n=945) were discontinued due to adverse experiences that were considered to be possibly, probably or definitely drug-related (1.6% for placebo; n=934).

Clinical adverse experiences that were reported as possibly, probably or definitely drug-related in ≥1% of patients treated with PROPECIA or placebo are presented in Table 1.

Integrated analysis of clinical adverse experiences showed that during treatment with PROPECIA, 36 (3.8%) of 945 men had reported one or more of these adverse experiences as compared to 20 (2.1%) of 934 men treated with placebo (p=0.04). Resolution occurred in men who discontinued therapy with PROPECIA due to these side effects and in most of those who continued therapy. The incidence of each of the above adverse experiences decreased to ≤0.3% by the fifth year of treatment with PROPECIA.

In a study of finasteride 1 mg daily in healthy men, a median decrease in ejaculate volume of 0.3 mL (-11%) compared with 0.2 mL (-8%) for placebo was observed after 48 weeks of treatment. Two other studies showed that finasteride at 5 times the dosage of PROPECIA (5 mg daily) produced significant median decreases of approximately 0.5 mL (-25%) compared to placebo in ejaculate volume, but this was reversible after discontinuation of treatment.

In the clinical studies with PROPECIA, the incidences for breast tenderness and enlargement, hypersensitivity reactions, and testicular pain in finasteride-treated patients were not different from those in patients treated with placebo.

[Omitted: trials of PROSCAR (finasteride 5 mg) and AVODART (dutasteride)]

6.2 Postmarketing Experience

The following adverse reactions have been identified during post approval use of PROPECIA…

Hypersensitivity Reaction: hypersensitivity reactions such as rash, pruritus, urticaria, and angioedema (including swelling of the lips, tongue, throat, and face);

Reproductive System: sexual dysfunction that continued after discontinuation of treatment, including erectile dysfunction, libido disorders, ejaculation disorders, and orgasm disorders; male infertility and/or poor seminal quality (normalization or improvement of seminal quality has been reported after discontinuation of finasteride); testicular pain; hematospermia.

Neoplasms: male breast cancer;

Breast disorders: breast tenderness and enlargement;

Nervous System/Psychiatric: depression, suicidal ideation and behavior

Note: In June 2022, FDA required a new adverse reaction to be added to Prescribing Information: suicidal ideation and behavior. It does not appear in Patient Information. Background is in a Reuters story and this post.


2022 updates required by FDA

View FDA letter (PDF)

Excerpt from p. 43 with emphasis added:

…[W]e are requiring that Organon make labeling changes under section 505(0)(4) of the FD&C Act to clarify the risks of use of Propecia. We are requiring the addition of suicidal ideation and behavior to the list of nervous system/psychiatric reactions in the ADVERSE REACTIONS (Postmarketing Experience) section… We are requiring that Organon change the Propecia labeling to add sexual adverse events mentioned in the ADVERSE REACTIONS (Clinical Trials Experience) section to PATIENT COUNSELING INFORMATION. We are requiring that the following reactions be added to the PATIENT COUNSELING INFORMATION section of the Propecia labeling: decreased libido, erectile dysfunction, and ejaculation disorder, including decreased ejaculate volume

See also: History of changes to the Propecia label