Medication Guide App

Proscar Side Effects

Generic Name: finasteride

Note: This page contains side effects data for the generic drug finasteride. It is possible that some of the dosage forms included below may not apply to the brand name Proscar.

It is possible that some side effects of Proscar may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

For the Consumer

Applies to finasteride: oral tablet

As well as its needed effects, finasteride (the active ingredient contained in Proscar) may cause unwanted side effects that require medical attention.

If any of the following side effects occur while taking finasteride, check with your doctor immediately:

More common
  • Chills
  • cold sweats
  • confusion
  • dizziness, faintness, or lightheadedness when getting up from a lying or sitting position
Less common
  • Bloating or swelling of the face, arms, hands, lower legs, or feet
  • breast enlargement and tenderness
  • hives or welts
  • itchy skin
  • rapid weight gain
  • redness of the skin
  • skin rash
  • swelling of the lips and face
  • tingling of the hands or feet
  • unusual weight gain or loss
Incidence not known
  • Clear or bloody discharge from the nipple
  • dimpling of the breast skin
  • inverted nipple
  • lump in the breast or under the arm
  • persistent crusting or scaling of the nipple
  • redness or swelling of the breast
  • sore on the skin of the breast that does not heal

Some finasteride side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:

More common
  • Decreased interest in sexual intercourse
  • inability to have or keep an erection
  • loss in sexual ability, desire, drive, or performance
Less common
  • Runny nose
  • sleepiness or unusual drowsiness
  • sneezing
  • stuffy nose
Less common or rare
  • Abdominal or stomach pain
  • back pain
  • decreased amount of semen
  • diarrhea
  • dizziness
  • headache
Incidence not known
  • Testicular pain

For Healthcare Professionals

Applies to finasteride: oral tablet

Genitourinary

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: Headache

Cardiovascular

Common (1% to 10%): Postural hypotension, hypotension
Postmarketing reports: Palpitations

Oncologic

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 cancer

Gastrointestinal

Frequency not reported: Nausea, flatulence, abdominal pain

Dermatologic

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 face

Metabolic

Common (1% to 10%): Edema

Respiratory

Uncommon (0.1% to 1%): Rhinitis, dyspnea

Psychiatric

Frequency not reported: Depression

Musculoskeletal

Frequency not reported: Asthenia

Hepatic

Frequency not reported: Increased hepatic enzymes

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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