Headache and nausea were reported clinical trials. These were generally mild or moderate in nature and occurred at a similar incidence in patients receiving placebo treatment. All other adverse reactions were added from post-marketing experience.
The pooled global placebo or active controlled clinical trials (n=2326 for Famvir arm) were retrospectively reviewed to obtain a frequency category for all adverse reactions mentioned as follows. Adverse drug reactions (Table 2) are listed according to system organ classes in MedDRA. Within each system organ class, the adverse drug reactions are ranked by frequency, with the most frequent reactions first. Within each frequency grouping, adverse drug reactions are presented in order of decreasing seriousness. In addition, the corresponding frequency category using the following convention (CIOMS III) is also provided for each adverse drug reaction: very common (≥1/10); common (≥1/100, <1/10); uncommon (≥1/1,000, <1/100); rare (≥1/10,000, <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data). (See Table 2.)
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