Proscar Side Effects

Generic Name: finasteride

Please note - some side effects for Proscar 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 Proscar - for the Consumer

Proscar

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Proscar:

Decreased sexual desire or ability.

Seek medical attention right away if any of these SEVERE side effects occur when using Proscar:

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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Proscar Side Effects - for the Professional

Proscar

Clinical Trials Experience

Proscar is generally well tolerated; adverse reactions usually have been mild and transient.

4-Year Placebo-Controlled Study (PLESS)

In PLESS, 1524 patients treated with Proscar and 1516 patients treated with placebo were evaluated for safety over a period of 4 years. The most frequently reported adverse reactions were related to sexual function. 3.7% (57 patients) treated with Proscar 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 1 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 1: Drug-Related Adverse Experiences

	Year 1 (%)		Years 2, 3 and 4* (%)
	Finasteride	Placebo	Finasteride	Placebo
N = 1524 and 1516, finasteride vs placebo, respectively
* Combined Years 2-4
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

Phase III Studies and 5-Year Open Extensions

The adverse experience profile in the 1-year, placebo-controlled, Phase III studies, the 5-year open extensions, and PLESS were similar.

Medical Therapy of Prostatic Symptoms (MTOPS) Study

In the MTOPS study, 3047 men with symptomatic BPH were randomized to receive Proscar 5 mg/day (n=768), doxazosin 4 or 8 mg/day (n=756), the combination of Proscar 5 mg/day and doxazosin 4 or 8 mg/day (n=786), or placebo (n=737) for 4 to 6 years. [See Clinical Studies (14.2).]

The incidence rates of drug-related adverse experiences reported by ≥2% of patients in any treatment group in the MTOPS Study are listed in Table 2.

The individual adverse effects which occurred more frequently in the combination group compared to either drug alone were: asthenia, postural hypotension, peripheral edema, dizziness, decreased libido, rhinitis, abnormal ejaculation, impotence and abnormal sexual function. Of these, the incidence of abnormal ejaculation in patients receiving combination therapy was comparable to the sum of the incidences of this adverse experience reported for the two monotherapies.

Combination therapy with finasteride and doxazosin was associated with no new clinical adverse experience.

Four patients in MTOPS reported the adverse experience breast cancer. Three of these patients were on finasteride only and one was on combination therapy. [See Long Term Data.]

The MTOPS Study was not specifically designed to make statistical comparisons between groups for reported adverse experiences. In addition, direct comparisons of safety data between the MTOPS study and previous studies of the single agents may not be appropriate based upon differences in patient population, dosage or dose regimen, and other procedural and study design elements.

Table 2: Incidence ≥2% in One or More Treatment Groups: Drug-Related Clinical Adverse Experiences in MTOPS

Adverse Experience		Placebo (N=737) (%)	Doxazosin 4 mg or 8 mg* (N=756) (%)	Finasteride (N=768) (%)	Combination (N=786) (%)
* Doxazosin dose was achieved by weekly titration (1 to 2 to 4 to 8 mg). The final tolerated dose (4 mg or 8 mg) was administered at end-Week 4. Only those patients tolerating at least 4 mg were kept on doxazosin. The majority of patients received the 8-mg dose over the duration of the study.
Body as a whole
Asthenia		7.1	15.7	5.3	16.8
Headache		2.3	4.1	2.0	2.3
Cardiovascular
Hypotension		0.7	3.4	1.2	1.5
Postural Hypotension		8.0	16.7	9.1	17.8
Metabolic and Nutritional
Peripheral Edema		0.9	2.6	1.3	3.3
Nervous
Dizziness		8.1	17.7	7.4	23.2
Libido Decreased		5.7	7.0	10.0	11.6
Somnolence		1.5	3.7	1.7	3.1
Respiratory
Dyspnea		0.7	2.1	0.7	1.9
Rhinitis		0.5	1.3	1.0	2.4
Urogenital
Abnormal Ejaculation		2.3	4.5	7.2	14.1
Gynecomastia		0.7	1.1	2.2	1.5
Impotence		12.2	14.4	18.5	22.6
Sexual Function Abnormal		0.9	2.0	2.5	3.1

Long-Term Data

High-Grade Prostate Cancer

The PCPT trial was a 7-year randomized, double-blind, placebo-controlled trial that enrolled 18,882 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%) [see Indications and Usage (1.3) and Warnings and Precautions (5.2)]. 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).

No clinical benefit has been demonstrated in patients with prostate cancer treated with Proscar.

Breast Cancer

During the 4- to 6-year placebo- and comparator-controlled MTOPS study that enrolled 3047 men, there were 4 cases of breast cancer in men treated with finasteride but no cases in men not treated with finasteride. 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 finasteride. 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 finasteride, 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.

Sexual Function

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

Postmarketing Experience

The following additional adverse effects have been reported in post-marketing experience with Proscar and/or finasteride at lower doses. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure:

• hypersensitivity reactions, including pruritus, urticaria, and swelling of the lips and face
• testicular pain
• erectile dysfunction that continued after discontinuation of treatment
• depression
• male breast 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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