Divalgen 250/Divalgen 500 Adverse Reactions

The most frequently reported adverse effects associated with valproate therapy are gastrointestinal disturbances, particularly at the start of therapy; enteric-coated formulations, taking doses with meals and starting with low doses may minimize symptoms. There may be increased appetite and weight gain in common. Less common adverse effects include oedema, headache, reversible prolongation of bleeding time, and thrombocytopenia. Leucopenia and bone marrow depression have been reported. Neurological adverse effects including ataxia, tremor, sedation, lethargy and confusion have been reported. Very rare cases of extrapyramidal symptoms or reversible dementia associated with cerebral atrophy have been reported. Increased alertness may occur, which is generally considered beneficial, but occasionally rashes and rarely hirsutism, acne, toxic epidermal necrolysis and Stevens-Johnson syndrome or erythema multiforme. Transient hair loss sometimes with regrowth of curly hair, has occurred. Irregular periods, amenorrhea and gynaecomastia have been reported rarely.
Liver dysfunction including hepatic failure has occasionally been reported, usually in the first few months of treatment, and requires valproate withdrawal; there have been fatalities. Elevation of liver enzyme values is common but normally transient and dose-related. Hyperammonemia has occurred, even in the absence of overt hepatic failure, and is sometimes associated with neurological symptoms; Hyperglycemia has been also reported. Pancreatitis has also been reported rarely, and fatalities have occurred; plasma amylase should be measured if there is acute abdominal pain, although the value of serum amylase as diagnostic tool has been questioned. In few patients there have been reports of reversible defects in renal tubular function (Fanconi's syndrome).
Congenital malformations have been reported in infants born to women who had received antiepileptics including valproate during pregnancy. Inflammatory reactions and pain have been reported at the injection site after intravenous doses.