Depakote ER Adverse Reactions

The following adverse reactions possibly related to valproates are displayed by MedDRA system organ class classification. Frequency groupings are classified according to the subsequent conventions: 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), Very rare (<1/10,000) and Not known (cannot be estimated from the available data). (See Tables 5a and 5b.)

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Pediatric population: The safety profile of valproate in the pediatric population is comparable to adults, but some adverse reactions are more severe or principally observed in the pediatric population. There is a particular risk of severe liver damage in infants and young children especially under the age of three years. Young children are also at particular risk of pancreatitis. These risks decrease with increasing age (see Pharmacology under Actions). Psychiatric disorders such as aggression, agitation, disturbance in attention, abnormal behavior, psychomotor hyperactivity and learning disorder are principally observed in the pediatric population.
Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorization of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system.