In the original clinical trials, 3.7% of men taking these drugs (and 4%–6% by some other estimates) developed erectile dysfunction. Sexual problems have continued in some men even after stopping treatment. Dutasteride-Tamsulosin Side Effects Dizziness, lightheadedness, drowsiness, runny/stuffy nose, sexual problems (such as decreased sexual interest/ability, ejaculation problems, decrease in the amount of semen/sperm), testicle pain/swelling, increased breast size, or breast tenderness may occur. There was a higher incidence of Gleason score 8-10 prostate cancer in men receiving AVODART (1.0%) compared with men on placebo (0.5%) [see No clinical benefit has been demonstrated in patients with prostate cancer treated with AVODART.In the 3 pivotal placebo-controlled BPH trials with AVODART, each 4 years in duration, there was no evidence of increased sexual adverse reactions (impotence, decreased libido, and ejaculation disorder) or breast disorders with increased duration of treatment. Table 2 summarizes adverse reactions reported in at least 1% of subjects in the combination group and at a higher incidence than subjects receiving monotherapy with AVODART or tamsulosin.In CombAT, after 4 years of treatment, the incidence of the composite term cardiac failure in the combination therapy group (12/1,610; 0.7%) was higher than in either monotherapy group: AVODART, 2/1,623 (0.1%) and tamsulosin, 9/1,611 (0.6%). Drug side effects … The population was aged 49 to 88 years (mean age: 66 years) and 88% were white. down the sink or in the toilet) or in household garbage. Overall, 1,623 subjects received monotherapy with dutasteride; 1,611 subjects … It is important to take this medication exactly as prescribed by your doctor. Subjects underwent protocol-mandated scheduled prostate biopsies at 2 and 4 years of treatment or had “for-cause biopsies” at non-scheduled times if clinically indicated. The following side effects have been reported by at least 1% of people taking this medication. Composite cardiac failure was also examined in a separate 4-year placebo-controlled trial evaluating AVODART in men at risk for development of prostate cancer. Because they affect levels of the male hormone testosterone, the 5–alpha-reductase inhibitors may cause a variety of sexual side effects. You may report side effects to FDA at 1-800-FDA-1088.This is not a complete list of side effects and others may occur. Tamsulosin is not suitable for some people. 3. Who can and can't take tamsulosin. Swallow the capsule whole. The main side effects of tamsulosin are feeling dizzy and problems when men ejaculate (such as little or no semen). To make sure this medicine is safe for you, tell a … If you experience worsening symptoms or symptoms that do not improve within 6 months, discuss this with your doctor. The group taking both dutasteride and tamsulosin showed significant improvements in BPH symptoms, urinary function and prostate volume after 2 years. If you miss a dose, take it as soon as possible and continue with your regular schedule. Ask your pharmacist how to dispose of medications that are no longer needed or have expired. Do not drive a car or perform hazardous tasks until you are certain that this medication does not impair your ability to perform these tasks safely. Table 1 summarizes clinical adverse reactions reported in at least 1% of subjects receiving AVODART and at a higher incidence than subjects receiving placebo.The REDUCE trial was a randomized, double-blind, placebo-controlled trial that enrolled 8,231 men aged 50 to 75 years with a serum PSA of 2.5 ng/mL to 10 ng/mL and a negative prostate biopsy within the previous 6 months. Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. The sexual side effects of dutasteride may continue after you stop taking this medicine. No causal relationship between AVODART alone or in combination with tamsulosin and cardiac failure has been established. Tamsulosin can be taken by adults (aged 18 and over).