"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"...
Propecia Side Effects Center
Medical Editor: Charles Patrick Davis, MD, PhD
Propecia is indicated for the treatment of male pattern hair loss (androgenetic alopecia) in men only. Propecia (finasteride) is available in generic form. Side effects of Propecia may include but are not limited to decrease in blood prostate specific antigen (PSA) levels, can affect the PSA blood test , and cause a decrease in sex drive.
Propecia is available in strength of 1 mg tablets;the recommended dose of Propecia is one tablet (1mg) taken once daily. In general daily use for three months is necessary before benefit is observed. Withdrawl of treatment leads to reversal of effect within 12 months. No drug interactions of clinical importance have been identified. Propecia is not indicated for use in women. Women should not handle crushed or broken Propecia tablets when they are pregnant or may potentially be pregnant. Caution should be used in older men who have benign prostatic hyperplasia (BPH), PSA levels are decreased by approximately 50%. Men aged 55 and over have increased risk of high grade prostate cancer with 5a-reductase inhibitors. Caution should be exercised in administration of Propecia in those patients with liver function abnormalities. Propecia is not indicated for use in pediatric patients.
Our Propecia (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.
Propecia 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 Propecia (Finasteride)
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Propecia 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 Propecia (Finasteride)
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Propecia FDA Prescribing Information: Side Effects
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
Clinical Studies for PROPECIA (finasteride 1 mg) in the Treatment of Male Pattern Hair Loss
In three controlled clinical trials for PROPECIA of 12-month duration, 1.4% of patients taking PROPECIA (n=945) were discontinued due to adverse experiences that were considered to be possibly, probably or definitely drug-related (1.6% for placebo; n=934).
Clinical adverse experiences that were reported as possibly, probably or definitely drug-related in ≥ 1% of patients treated with PROPECIA or placebo are presented in Table 1.
TABLE 1: Drug-Related Adverse Experiences for PROPECIA
(finasteride 1 mg) in Year 1 (%) MALE PATTERN HAIR LOSS
|Ejaculation Disorder (Decreased Volume of Ejaculate)||1.2 (0.8)||0.7 (0.4)|
|Discontinuation due to drug-related sexual adverse experiences||1.2||0.9|
Integrated analysis of clinical adverse experiences showed that during treatment with PROPECIA, 36 (3.8%) of 945 men had reported one or more of these adverse experiences as compared to 20 (2.1%) of 934 men treated with placebo (p=0.04). Resolution occurred in men who discontinued therapy with PROPECIA due to these side effects and in most of those who continued therapy. The incidence of each of the above adverse experiences decreased to ≤ 0.3% by the fifth year of treatment with PROPECIA.
In a study of finasteride 1 mg daily in healthy men, a median decrease in ejaculate volume of 0.3 mL (- 11%) compared with 0.2 mL (-8%) for placebo was observed after 48 weeks of treatment. Two other studies showed that finasteride at 5 times the dosage of PROPECIA (5 mg daily) produced significant median decreases of approximately 0.5 mL (-25%) compared to placebo in ejaculate volume, but this was reversible after discontinuation of treatment.
In the clinical studies with PROPECIA, the incidences for breast tenderness and enlargement, hypersensitivity reactions, and testicular pain in finasteride-treated patients were not different from those in patients treated with placebo.
Controlled Clinical Trials and Long-Term Open Extension Studies for PROSCAR® (finasteride 5 mg) and AVODART (dutasteride) in the Treatment of Benign Prostatic Hyperplasia
In the PROSCAR Long-Term Efficacy and Safety Study (PLESS), a 4-year controlled clinical study, 3040 patients between the ages of 45 and 78 with symptomatic BPH and an enlarged prostate were evaluated for safety over a period of 4 years (1524 on PROSCAR 5 mg/day and 1516 on placebo). 3.7% (57 patients) treated with PROSCAR 5 mg 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 2 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 2: Drug-Related Adverse Experiences for PROSCAR (finasteride
5 mg) BENIGN PROSTATIC HYPERPLASIA
|Year 1 (%)||Years 2, 3 and 4* (%)|
|Finasteride 5 mg||Placebo||Finasteride 5 mg||Placebo|
|Decreased Volume of Ejaculate||3.7||0.8||1.5||0.5|
|*Combined Years 2-4
N = 1524 and 1516, finasteride vs placebo, respectively
The adverse experience profiles in the 1-year, placebo-controlled, Phase III BPH studies and the 5-year open extensions with PROSCAR 5 mg and PLESS were similar.
There is no evidence of increased sexual adverse experiences with increased duration of treatment with PROSCAR 5 mg. New reports of drug-related sexual adverse experiences decreased with duration of therapy.
During the 4- to 6-year placebo- and comparator-controlled Medical Therapy of Prostatic Symptoms (MTOPS) study that enrolled 3047 men, there were 4 cases of breast cancer in men treated with PROSCAR but no cases in men not treated with PROSCAR. 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 were reported in men treated with PROSCAR.
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 PROSCAR, 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.
The PCPT trial was a 7-year randomized, double-blind, placebo-controlled trial that enrolled 18,882 healthy 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%). In a 4-year placebo-controlled clinical trial with another 5α-reductase inhibitor [AVODART (dutasteride)], similar results for Gleason score 8-10 prostate cancer were observed (1% dutasteride vs 0.5% placebo). The clinical significance of these findings with respect to use of PROPECIA by men is unknown.
No clinical benefit has been demonstrated in patients with prostate cancer treated with PROSCAR. PROSCAR is not approved to reduce the risk of developing prostate cancer.
The following adverse reactions have been identified during post approval use of PROPECIA. 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:
Reproductive System: sexual dysfunction that continued after discontinuation of treatment, including erectile dysfunction, libido disorders, ejaculation disorders, and orgasm disorders; male infertility and/or poor seminal quality (normalization or improvement of seminal quality has been reported after discontinuation of finasteride); testicular pain.
Neoplasms: male breast cancer;
Breast disorders: breast tenderness and enlargement;
Nervous System/Psychiatric: depression
Read the entire FDA prescribing information for Propecia (Finasteride)
Additional Propecia Information
Propecia - User Reviews
Propecia User Reviews
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