Reactions from Clinical Trials or Postmarketing Surveillance: The clinical adverse events that occurred in at least one of the 885 patients receiving propafenone hydrochloride sustained release (SR) in five phase II studies and two phase III studies are shown in the table as follows. It is expected that the adverse reactions and frequencies for immediate release (IR) formulations would be similar. This table also includes adverse reactions from post-marketing experience with propafenone. The reactions considered at least possibly related to propafenone are displayed by system organ class and frequency using the following convention: very common (≥ 1/10), common (≥ 1/100 to <1/10), uncommon (≥ 1/1000 to <1/100) and not known (adverse reactions from post-marketing experience; cannot be estimated from the available data). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness when the seriousness could be assessed. (See table.)
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