Simdax Adverse Reactions

In placebo-controlled clinical trials for ADHF (REVIVE programme), 53% of patients experienced adverse reactions, the most frequent of which were ventricular tachycardia, hypotension, and headache.
In a dobutamine-controlled clinical trial for ADHF (SURVIVE), 18% of patients experienced adverse reactions, the most frequent of which were ventricular tachycardia, atrial fibrillation, hypotension, ventricular extrasystoles, tachycardia, and headache.
The following table describes the adverse reactions observed in 1% or greater of patients during REVIVE I, REVIVE II, SURVIVE, LIDO, RUSSLAN, 300105, and 3001024 clinical trials. If the incidence of any particular event in an individual trial was greater than that seen across the other trials, then the higher incidence is reported in the table.
The events considered at least possibly related to levosimendan are displayed by system organ class and frequency, using the following convention: very common (≥ 1/10), common (≥ 1/100, < 1/10). (See Table 3.)

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Post-marketing adverse reactions: In post-marketing experience, ventricular fibrillation has been reported in patients being administered Simdax.