ADVERSE REACTIONS
Clinical Studies for PROPECIA (finasteride 1 mg) in the Treatment of Male Pattern Hair Loss
In controlled clinical trials for PROPECIA of 12-month duration, 1.4% of the patients were discontinued due to
adverse experiences that were considered to be possibly, probably or definitely drug-related (1.6% for placebo); 1.2%
of patients on PROPECIA and 0.9% of patients on placebo discontinued therapy because of a drug-related sexual
adverse experience. The following clinical adverse reactions were reported as possibly, probably or definitely drugrelated
in ?1% of patients treated for 12 months with PROPECIA or placebo, respectively: decreased libido (1.8%,
1.3%), erectile dysfunction (1.3%, 0.7%) and ejaculation disorder (1.2%, 0.7%; primarily decreased volume of
ejaculate:[0.8%, 0.4%]). 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 all men who discontinued therapy with
PROPECIA due to these side effects and in 58% of those who continued therapy.
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, and for
hypersensitivity reactions in finasteride-treated patients were not different from those in patients treated with placebo.
Controlled Clinical Trials and Long-Term Open Extension Studies for PROSCAR* (finasteride 5 mg) in the Treatment
of Benign Prostatic Hyperplasia
In controlled clinical trials for PROSCAR of 12-month duration, 1.3% of the patients were discontinued due to
adverse experiences that were considered to be possibly, probably or definitely drug-related (0.9% for placebo); only
one patient on PROSCAR (0.2%) and one patient on placebo (0.2%) discontinued therapy because of a drug-related
sexual adverse experience. The following clinical adverse reactions were reported as possibly, probably or definitely
drug-related in ?1% of patients treated for 12 months with PROSCAR or placebo, respectively: erectile dysfunction
(3.7%, 1.1%), decreased libido (3.3%, 1.6%) and decreased volume of ejaculate (2.8%, 0.9%). The adverse
experience profiles for patients treated with finasteride 1 mg/day for 12 months and those maintained on PROSCAR
for 24 to 48 months were similar to that observed in the 12-month controlled studies with PROSCAR. Sexual adverse
experiences resolved with continued treatment in over 60% of patients who reported them.
Adverse Effects Reported in Post-Marketing Experience for PROSCAR (finasteride 5 mg)
Breast tenderness and enlargement, as well as hypersensitivity reactions, including lip swelling and skin rash
have been reported.
