The most commonly reported adverse drug reaction in clinical trials with Venofer was dysgeusia, which occurred with a rate of 4.5 events per 100 subjects. The most important serious adverse drug reactions associated with Venofer are hypersensitivity reactions, which occurred with a rate of 0.25 events per 100 subjects in clinical trials. Anaphylactoid/anaphylactic reactions were reported only in the post-marketing setting (estimated rate of less than 0.075 events per 100 subjects); fatalities have been reported. See Precautions.
The adverse drug reactions reported after the administration of Venofer in 4,046 subjects in clinical trials as well as those reported from the post-marketing setting are presented in the table as follows. (See Table 3.)
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