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Side Effects & Drug Interactions
ADVERSE REACTIONS
Tadalafil was administered to over 5700 men (mean age 59, range 19 to 87 years) during clinical trials worldwide. Over 1000 patients were treated for 1 year or longer and over 1300 patients were treated for 6 months or more. In placebo-controlled Phase 3 clinical trials, the discontinuation rate due to adverse events in patients treated with tadalafil 10 or 20 mg was 3.1%, compared to 1.4% in placebo-treated patients. When tadalafil was taken as recommended in the placebo-controlled clinical trials, the following adverse events were reported (see Table 7): Text Continues Below
Back pain or myalgia was reported at incidence rates described in Table 7. In tadalafil clinical pharmacology trials, back pain or myalgia generally occurred 12 to 24 hours after dosing and typically resolved within 48 hours. The back pain/ myalgia associated with tadalafil treatment was characterized by diffuse bilateral lower lumbar, gluteal, thigh, or thoracolumbar muscular discomfort and was exacerbated by recumbancy. In general, pain was reported as mild or moderate in severity and resolved without medical treatment, but severe back pain was reported infrequently (< 5% of all reports). When medical treatment was necessary, acetaminophen or non-steroidal anti-inflammatory drugs were generally effective; however, in a small percentage of subjects who required treatment, a mild narcotic (e. g. codeine) was used. Overall, approximately 0.5% of all tadalafil-treated subjects discontinued treatment as a consequence of back pain/ myalgia. Diagnostic testing, including measures for inflammation, muscle injury, or renal damage revealed no evidence of medically significant underlying pathology. Across all studies with any tadalafil dose, reports of changes in color vision were rare (< 0.1% of patients). Page: 1 | 2 | 3 | 4 | 5 | Next >>
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