Tamsulosin Hydrochloride Side Effects

6 ADVERSE REACTIONS The most common adverse events (≥2% of patients and at a higher incidence than placebo) with the 0.4 mg dose or 0.8 mg dose were headache, dizziness, rhinitis, infection, abnormal ejaculation, asthenia, back pain, diarrhea, pharyngitis, chest pain, cough increased, somnolence, nausea, sinusitis, insomnia, libido decreased, tooth disorder, and blurred vision (6.1) To report SUSPECTED ADVERSE REACTIONS, contact XLCare Pharmaceuticals, Inc.

at 1-866-495-1995 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1 Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reactions rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.

The incidence of treatment-emergent adverse events has been ascertained from six short-term U.S.

and European placebo-controlled clinical trials in which daily doses of 0.1 to 0.8 mg tamsulosin hydrochloride capsules were used.

These studies evaluated safety in 1783 patients treated with tamsulosin hydrochloride capsules and 798 patients administered placebo.

Table 1 summarizes the treatment-emergent adverse events that occurred in ≥2% of patients receiving either tamsulosin hydrochloride capsules 0.4 mg or 0.8 mg and at an incidence numerically higher than that in the placebo group during two 13-week U.S.

trials (US92-03A and US93-01) conducted in 1487 men.

Table 1 Treatment-Emergent* Adverse Events Occurring in ≥2% of Tamsulosin Hydrochloride Capsules or Placebo Patients in Two U.S.

Short-Term Placebo-Controlled Clinical Studies BODY SYSTEM/ ADVERSE EVENT TAMSULOSIN HYDROCHLORIDE CAPSULES GROUPS PLACEBO 0.4 mg n=502 0.8 mg n=492 n=493 BODY AS WHOLE Headache 97 (19.3%) 104 (21.1%) 99 (20.1%) Infection† 45 (9%) 53 (10.8%) 37 (7.5%) Asthenia 39 (7.8%) 42 (8.5%) 27 (5.5%) Back pain 35 (7%) 41 (8.3%) 27 (5.5%) Chest pain 20 (4%) 20 (4.1%) 18 (3.7%) NERVOUS SYSTEM Dizziness 75 (14.9%) 84 (17.1%) 50 (10.1%) Somnolence 15 (3%) 21 (4.3%) 8 (1.6%) Insomnia 12 (2.4%) 7 (1.4%) 3 (0.6%) Libido decreased 5 (1%) 10 (2%) 6 (1.2%) RESPIRATORY SYSTEM Rhinitis‡ 66 (13.1%) 88 (17.9%) 41 (8.3%) Pharyngitis 29 (5.8%) 25 (5.1%) 23 (4.7%) Cough increased 17 (3.4%) 22 (4.5%) 12 (2.4%) Sinusitis 11 (2.2%) 18 (3.7%) 8 (1.6%) DIGESTIVE SYSTEM Diarrhea 31 (6.2%) 21 (4.3%) 22 (4.5%) Nausea 13 (2.6%) 19 (3.9%) 16 (3.2%) Tooth disorder 6 (1.2%) 10 (2%) 7 (1.4%) UROGENITAL SYSTEM Abnormal ejaculation 42 (8.4%) 89 (18.1%) 1 (0.2%) SPECIAL SENSES Blurred vision 1 (0.2%) 10 (2%) 2 (0.4%) * A treatment-emergent adverse event was defined as any event satisfying one of the following criteria: The adverse event occurred for the first time after initial dosing with double-blind study medication;