Propecia Side Effects

Generic Name: finasteride

Please note - some side effects for Propecia may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of Propecia - for the Consumer

Propecia

All medicines may cause side effects, but many people have no, or minor, side effects. No COMMON side effects have been reported with Propecia. Seek medical attention right away if any of these SEVERE side effects occur when using Propecia:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); breast enlargement, lumps, pain, or tenderness; depression; nipple discharge; testicular pain.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

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Propecia Side Effects - for the Professional

Propecia

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.

TABLE 1. Drug-Related Adverse Experiences for Propecia (finasteride 1 mg) in Year 1 (%) MALE PATTERN HAIR LOSS

	Propecia N=945	Placebo N=934
Decreased Libido	1.8	1.3
Erectile Dysfunction	1.3	0.7
Ejaculation Disorder   (Decreased Volume of Ejaculate)	1.2 (0.8)	0.7 (0.4)
Discontinuation due to drug-related sexual adverse experiences	1.2	0.9

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.

Postmarketing Experience for Propecia (finasteride 1 mg)

Breast tenderness and enlargement; depression; hypersensitivity reactions including rash, pruritus, urticaria, and swelling of the lips and face; testicular pain; erectile dysfunction that continued after discontinuation of treatment; and male breast cancer. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate the frequency or establish a causal relationship to drug exposure. See Controlled Clinical Trials and Long-Term Open Extension Studies for PROSCAR® (finasteride 5 mg) in the Treatment of Benign Prostatic Hyperplasia.

Controlled Clinical Trials and Long-Term Open Extension Studies for PROSCAR® (finasteride 5 mg) in the Treatment of Benign Prostatic Hyperplasia

In the PROSCAR Long-Term Efficacy and Safety Study (PLESS), a 4-year controlled clinical study, 3040 patients between the ages of 45 and 78 with symptomatic BPH and an enlarged prostate were evaluated for safety over a period of 4 years (1524 on PROSCAR 5 mg/day and 1516 on placebo). 3.7% (57 patients) treated with PROSCAR 5 mg and 2.1% (32 patients) treated with placebo discontinued therapy as a result of adverse reactions related to sexual function, which are the most frequently reported adverse reactions.

Table 2 presents the only clinical adverse reactions considered possibly, probably or definitely drug related by the investigator, for which the incidence on PROSCAR was ≥1% and greater than placebo over the 4 years of the study. In years 2-4 of the study, there was no significant difference between treatment groups in the incidences of impotence, decreased libido and ejaculation disorder.

TABLE 2. Drug-Related Adverse Experiences for PROSCAR (finasteride 5 mg) BENIGN PROSTATIC HYPERPLASIA

N = 1524 and 1516, finasteride vs placebo, respectively
* Combined Years 2-4
	Year 1 (%)		Years 2, 3 and 4* (%)
	Finasteride, 5 mg	Placebo	Finasteride, 5 mg	Placebo
Impotence	8.1	3.7	5.1	5.1
Decreased Libido	6.4	3.4	2.6	2.6
Decreased Volume of Ejaculate	3.7	0.8	1.5	0.5
Ejaculation Disorder	0.8	0.1	0.2	0.1
Breast Enlargement	0.5	0.1	1.8	1.1
Breast Tenderness	0.4	0.1	0.7	0.3
Rash	0.5	0.2	0.5	0.1

The adverse experience profiles in the 1-year, placebo-controlled, Phase III BPH studies and the 5-year open extensions with PROSCAR 5 mg and PLESS were similar.

There is no evidence of increased adverse experiences with increased duration of treatment with PROSCAR 5 mg. New reports of drug-related sexual adverse experiences decreased with duration of therapy.

During the 4- to 6-year placebo- and comparator-controlled Medical Therapy of Prostatic Symptoms (MTOPS) study that enrolled 3047 men, there were 4 cases of breast cancer in men treated with PROSCAR but no cases in men not treated with PROSCAR. During the 4-year placebo-controlled PLESS study that enrolled 3040 men, there were 2 cases of breast cancer in placebo-treated men but no cases in men treated with PROSCAR. During the 7-year placebo-controlled Prostate Cancer Prevention Trial (PCPT) that enrolled 18,882 men, there was 1 case of breast cancer in men treated with PROSCAR, and 1 case of breast cancer in men treated with placebo. The relationship between long-term use of finasteride and male breast neoplasia is currently unknown.

The PCPT trial was a 7-year randomized, double-blind, placebo-controlled trial that enrolled 18,882 healthy men ≥55 years of age with a normal digital rectal examination and a PSA ≤3.0 ng/mL. Men received either PROSCAR (finasteride 5 mg) or placebo daily. Patients were evaluated annually with PSA and digital rectal exams. Biopsies were performed for elevated PSA, an abnormal digital rectal exam, or the end of study. The incidence of Gleason score 8-10 prostate cancer was higher in men treated with finasteride (1.8%) than in those treated with placebo (1.1%). In a 4-year placebo-controlled clinical trial with another 5α-reductase inhibitor (dutasteride, AVODART), similar results for Gleason score 8-10 prostate cancer were observed (1% dutasteride vs 0.5% placebo). The clinical significance of these findings with respect to use of Propecia by men is unknown.

No clinical benefit has been demonstrated in patients with prostate cancer treated with PROSCAR. PROSCAR is not approved to reduce the risk of developing prostate cancer.

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Side Effects by Body System - for Healthcare Professionals

Genitourinary

Two hundred fourteen reports of gynecomastia in men taking finasteride in the United States were received by the FDA between June 1992 and February 1995. Among those reported, fifty eight percent were taking additional medications that have been associated with gynecomastia. Sixty nine of 86 patients who discontinued finasteride treatment had partial or complete remission.

New reports of drug-related sexual adverse experiences have been reported to decrease with duration of therapy.

Genitourinary side effects have included impotence (1.1% to 18.5%), abnormal ejaculation (7.2%), decreased ejaculatory volume (0.9% to 2.8%), abnormal sexual function (2.5%), gynecomastia (2.2%), erectile dysfunction (1.3%), ejaculation disorder (1.2%), and testicular pain. The manufacturer has reported that in controlled clinical trials, 1.2% of patients on finasteride tablets discontinued therapy because of a drug-related sexual adverse experience.

Endocrine

Endocrine side effects have included reductions in prostate specific antigen (PSA) levels of approximately 50%.

Finasteride may cause a decrease in PSA levels in patients with benign prostatic hyperplasia as well as in patients with prostate cancer. In one study, mean PSA reductions of 50% were noted, regardless of baseline levels. There was no indication that PSA levels were further suppressed in patients with prostate cancer.

PSA levels are commonly used in the screening process for prostate cancer. Patients who develop sustained increases in PSA while on finasteride therapy should be carefully evaluated for medical causes as well as noncompliance.

Nervous system

Nervous system side effects including decreased libido (1.6% to 10.0%), dizziness (7.4%), and somnolence (1.7%) have been reported.

Cardiovascular

Cardiovascular side effects including postural hypotension (9.1%) and hypotension (1.2%) have been reported.

General

General side effects including asthenia (5.3%), dizziness, headache, and abdominal pain have been reported.

Oncologic

Oncologic side effects have included a prevention or delay in the appearance of prostate cancer. However, finasteride has also been linked to an increased risk of high grade prostate cancer. Postmarketing experience has included rare cases of male breast cancer.

Gastrointestinal

Gastrointestinal side effects including nausea and flatulence have been reported.

Dermatologic

A 58 year old man presented with an itchy, lumpy rash on upper and lower extremities following two weeks of finasteride treatment for prostatism. The patient had no known allergies and was taking no other medications prior to the episode. The finasteride was discontinued and dapsone was initiated. The rash resolved two weeks after finasteride therapy was stopped.

Dermatologic side effects including rash have been rare. At least one case of cutaneous leukocytoclastic vasculitis has been associated with finasteride therapy. A case of solitary fixed drug eruption has also been reported.

Hypersensitivity

Hypersensitivity side effects including pruritus, urticaria, and swelling of the lips and face have been reported.

Metabolic

Metabolic side effects including peripheral edema (1.3%) have been reported.

Respiratory

Respiratory side effects including rhinitis (1.0%) and dyspnea (0.7%) have been reported.

Psychiatric

Psychiatric side effects have included depression.

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