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Note: This document contains side effect information about finasteride. Some of the dosage forms listed on this page may not apply to the brand name Proscar.In Summary
Common side effects of Proscar include: impotence and decreased libido. See below for a comprehensive list of adverse effects.For the Consumer
Applies to finasteride: oral tablet
Along with its needed effects, finasteride (the active ingredient contained in Proscar) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur while taking finasteride:
Incidence not known
Some side effects of finasteride may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Less common or rare
Incidence not known
For Healthcare Professionals
Applies to finasteride: oral tabletGenitourinary
Most men were older and were taking concomitant medications and/or had comorbid conditions:
Very common (10% or more): Impotence (up to 18.5%)
Common (1% to 10%): Abnormal ejaculation, decreased ejaculatory volume, abnormal sexual function, gynecomastia, erectile dysfunction, ejaculation disorder, testicular pain, male infertility and/or poor seminal quality
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.
Erectile dysfunction has been reported to continue beyond treatment discontinuation. Normalization or improvement of seminal quality has been reported after withdrawing finasteride treatment.Endocrine
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 (the active ingredient contained in Proscar) therapy should be carefully evaluated for medical causes as well as noncompliance.
Uncommon (0.1% to 1%): Breast tenderness, breast enlargement
Frequency not reported: Reductions in prostate specific antigen (PSA) levels of approximately 50%Nervous system
Common (1% to 10%): Decreased libido, dizziness, somnolence
Frequency not reported: HeadacheCardiovascular
Common (1% to 10%): Postural hypotension, hypotension
Postmarketing reports: PalpitationsOncologic
Frequency not reported: A prevention or delay in the appearance of prostate cancer, an increased risk of high-grade prostate cancer
Postmarketing reports: Rare cases of male breast cancerGastrointestinal
Frequency not reported: Nausea, flatulence, abdominal painDermatologic
A 58 year old man presented with an itchy, lumpy rash on upper and lower extremities following two weeks of finasteride (the active ingredient contained in Proscar) 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.
Rare (less than 0.1%): Rash
Very rare (less than 0.01%): Cutaneous leukocytoclastic vasculitis, solitary fixed drug eruption
Postmarketing reports: Pruritus, urticaria, angioedema (including swelling of the lips, tongue, throat, and face)Hypersensitivity
Frequency not reported: Pruritus, urticaria, angioedema of the lips, tongue, throat, and faceMetabolic
Common (1% to 10%): EdemaRespiratory
Uncommon (0.1% to 1%): Rhinitis, dyspneaPsychiatric
Frequency not reported: DepressionMusculoskeletal
Frequency not reported: AstheniaHepatic
Frequency not reported: Increased hepatic enzymes
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