Pletaal Adverse Reactions

Clinical Study Data: Peripheral Arterial Disease: Table 2 shows the adverse experiences reported during placebo-controlled clinical trials of Pletaal at 50 or 100mg twice a day for 12 to 24 weeks. Included are adverse experiences that occurred in ≥2% of patients and, at 100mg twice a day, occurred at a higher rate than with placebo and are considered to have a causal relationship based on the mechanism of action or previous findings.
Table 2 lists the types of adverse events reported with Pletaal exposure, although varying incidence rates were observed in similar clinical studies conducted in different geographic areas. The incidence rates in Table 2 represent that which was observed in the trials conducted in the United States, which were the highest rates observed over all clinical trials. (See Table 2.)

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Prevention of stroke recurrence: Table 3 lists adverse drug reactions (ADRs) reported during post-marketing study of Pletaal in Japan. Included are ADRs that occurred with a significantly higher rate in patients treated with Pletaal that in Aspirin. (See Table 3.)

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Other Post-marketing Data: Table 4 shows the additional ADRs to Pletaal not included in the clinical studies tables (Table 2 and 3), reported spontaneously during the post-marketing period. The exact rate of these spontaneously reported ADRs is unknown. (See Table 4.)

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