Vigadexa Adverse Reactions




Full Prescribing Info
Adverse Reactions
Tabulated summary of adverse drug reactions from clinical trials: The following adverse reactions have been reported during clinical trials with Vigadexa and are classified according to the subsequent convention: very common (≥ 1/10), common (≥ 1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), and very rare (<1/10,000). Within each frequency-grouping, adverse reactions are presented in order of decreasing seriousness. (See Table 1.)

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Adverse drug reactions from spontaneous reports and literature cases (frequency not known): The following adverse drug reactions have been derived from post-marketing experience with Vigadexa via spontaneous case reports and literature cases. Because these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency which is therefore categorized as not known. Adverse drug reactions are listed according to system organ classes in MedDRA. Within each system organ class, ADRs are presented in order of decreasing seriousness. (See Table 2.)

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Additional adverse reactions reported with the individual components of Moxifloxacin/Dexamethasone Eye Drops, Solution are listed in the product information for Moxifloxacin Eye Drops, Solution and Dexamethasone Eye Drops, Solution.
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