Finasteride Side Effects
Brand Names: Propecia, Proscar
Please note - some side effects for Finasteride may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).
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For the consumer For the professional
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Side Effects of Finasteride - for the consumer
Finasteride
All medicines may cause side effects, but many people have no, or minor, side effects. No COMMON side effects have been reported with Finasteride . Seek medical attention right away if any of these SEVERE side effects occur when using Finasteride:
TopSevere 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; nipple discharge; testicular pain.
For the professional
Finasteride
Finasteride is generally well tolerated; adverse reactions usually have been mild and transient.
4-Year Placebo-Controlled Study
In a long-term efficacy and safety study, 1524 patients treated with Finasteride 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 Finasteride 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 Finasteride was ≥1% and greater than placebo over the 4 years of the study. In years 2 to 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 | |
| *Combined Years 2 to 4 N = 1524 and 1516, Finasteride vs placebo, respectively | ||||
| 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 a long-term efficacy and safety study were similar.
Long-Term Data
There is no evidence of increased adverse experiences with increased duration of treatment with Finasteride. New reports of drug-related sexual adverse experiences decreased with duration of therapy.
During the 4- to 6-year placebo- and comparator-controlled 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 a long-term efficacy and safety study that enrolled 3040 men, there were 2 cases of breast cancer in placebo-treated men, but no cases were reported in men treated with Finasteride. The relationship between long-term use of Finasteride and male breast neoplasia is currently unknown.
In a 7-year placebo-controlled trial that enrolled 18,882 healthy men, 9060 had prostate needle biopsy data available for analysis. In the Finasteride group, 280 (6.4%) men had prostate cancer with Gleason scores of 7 to 10 detected on needle biopsy vs. 237 (5.1%) men in the placebo group. Of the total cases of prostate cancer diagnosed in this study, approximately 98% were classified as intracapsular (stage T1 or T2). The clinical significance of these findings is unknown. This information from the literature (Thompson IM, Goodman PJ, Tangen CM, et al. The influence of Finasteride on the development of prostate cancer. N Engl J Med 2003;349:213-22) is provided for consideration by physicians when Finasteride is used as indicated. Finasteride is not approved to reduce the risk of developing prostate cancer.
Post-Marketing Experience
The following additional adverse effects have been reported in post-marketing experience:
- hypersensitivity reactions, including pruritus, urticaria, and swelling of the lips and face
- testicular painTop
More resources:
Finasteride - Includes detailed dosage instructions.
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