Liver dysfunction (see Precautions).
Teratogenic risk (see Precautions).
Confusion or Convulsions: Few cases of stupor have been described during sodium valproate therapy; they were isolated or associated with an increase in the occurrence of seizures whilst on therapy, and they decrease on withdrawal of treatment or reduction of dosage. These cases have most often been reported during combined therapy (in particular with phenobarbital) or after a sudden increase in valproate doses.
Digestive disorders (nausea, gastralgia) may occur in some patients at the start of treatment, but they usually disappear after a few days without discontinuing the treatment.
Transient and/or dose-related undesirable effects have been reported: Hair loss, fine postural tremor, hyperammononaemia without changes in hepatic tests. When using Depakine IV, nausea or dizziness may occur a few minutes after injection: They disappear spontaneously within a few minutes.
Isolated reduction of fibrinogen or increase in bleeding time have been reported, usually without associated clinical signs and particularly with high doses (sodium valproate has inhibitory effect on the 2nd phase of platelet aggregation).
Anaemia, leucopaenia, thrombocytopaenia or pancytopaenia have also been reported.
Pancreatitis, sometimes resulting in fatalities, have been described.
The occurrence of vasculitis has been reported.
Increase in weight may occur; amenorrhea and irregular periods have also been reported.
Hearing loss, either reversible or irreversible, has been reported; however, a cause-and-effect relationship has not been established.