"April 13, 2012 -- The baldness drug Propecia and the BPH drug Proscar may cause infertility and more sexual problems than previously thought, the FDA warns.
The main ingredient of both drugs is finasteride. Finasteride reduces male ho"...
Proscar Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Proscar (finasteride) works by decreasing the amount of a natural body hormone dihydrotestosterone (DHT) that causes growth of the prostate and is used to treat symptoms of benign prostatic hyperplasia (BPH) in men with an enlarged prostate. Proscar is available in generic form. Common side effects of Proscar include impotence, loss of interest in sex, trouble having an orgasm, abnormal ejaculation, swelling in your hands or feet, swelling or tenderness in your breasts, dizziness, weakness, feeling faint, headache, runny nose, or skin rash. In some men, Proscar can decrease the amount of semen released during sex. This is harmless. Proscar may also increase hair growth.
The recommended dose of Proscar is one tablet (5 mg) taken once a day. Other drugs may interact with Proscar. Tell your doctor all prescription and over-the-counter medications and supplements you use. Proscar is not recommended for use in women and must not be used during pregnancy. This medication is not usually used in women. Therefore, it is unlikely to be used during pregnancy or breast-feeding.
Our Proscar (finasteride) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Proscar in Detail - Patient Information: Side Effects
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you notice any breast lumps, pain, nipple discharge, or other breast changes. These may be signs of male breast cancer.
Less serious side effects may include:
- impotence, loss of interest in sex, or trouble having an orgasm;
- abnormal ejaculation;
- swelling in your hands or feet;
- swelling or tenderness in your breasts;
- dizziness, weakness;
- feeling like you might pass out;
- runny nose; or
- skin rash.
The sexual side effects of finasteride (decreased libido, trouble having an erection, ejaculation problems) may continue after you stop taking this medication. Talk to your doctor if you have concerns about these side effects.
Read the entire detailed patient monograph for Proscar (Finasteride)
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Proscar Overview - Patient Information: Side Effects
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor immediately if any of these unlikely but serious side effects occur: lump in the breast, nipple discharge, breast enlargement/tenderness/pain, pain in the testicles, inability to urinate.
A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the entire patient information overview for Proscar (Finasteride)
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Proscar FDA Prescribing Information: Side Effects
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* (%)|
|Decreased Volume of Ejaculate||3.7||0.8||1.5||0.5|
|*Combined Years 2-4
N = 1524 and 1516, finasteride vs placebo, respectively
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 .]
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 (see Table 2). 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
|Doxazosin 4 mg or 8 mg*
|Body as a whole|
|Metabolic and Nutritional|
|*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.|
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]. 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.
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 7year 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.
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.
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 (ED) that continued after discontinuation of treatment, reported rarely in men taking PROSCAR for the treatment of BPH. Most men were older and were taking concomitant medications and/or had co-morbid conditions with a known association to ED. The independent role of PROSCAR in these events is unknown.
- male infertility and/or poor seminal quality have been reported rarely in men taking PROSCAR for the treatment of BPH. The independent role of PROSCAR in these events is unknown. Normalization or improvement of seminal quality has been reported after discontinuation of finasteride.
- decreased libido that continued after discontinuation of treatment
- male breast cancer.
Read the entire FDA prescribing information for Proscar (Finasteride)
Additional Proscar Information
Proscar - User Reviews
Proscar User Reviews
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