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Where applicable, the following frequency rating has been used: Very common (> 1/10); common (> 1/100 to 1/10); uncommon (> 1/1000 to 1/100); rare (> 1/10000 to 1/1000); very rare (1/10000), including "isolated reports".
Congenital and familial/genetic disorders: (See "Use in Pregnancy & Lactation").
Hepato-biliary disorders: Rare cases of liver dysfunction (see "Warnings").
Gastrointestinal disorders: Nausea, gastralgia, diarrhoea frequently occurs in some patients at the start of treatment, but they usually disappear after a few days without discontinuing the treatment.
Cases of pancreatitis: Very rare, sometimes lethal, have been reported (see "Warnings").
Nervous system disorders: Confusion; a few cases of stupor or lethargy sometimes leading to transient coma (encephalopathy) have been described during sodium valproate therapy; they were isolated or associated with an increase in the occurrence of convulsions whilst on therapy, and they decreased 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. Very rare cases of reversible dementia associated with reversible cerebral atrophy have been reported. Isolated reversible Parkinsonism has been reported. Transient and (or) dose related fine postural tremor and somnolence have often been reported.
Metabolic disorders: Cases of isolated and moderate hyperammonemia without change in liver function tests may frequently occur and should not cause treatment discontinuation. Hyperammonemia associated with neurological symptoms have also been reported. In such cases further investigations should be considered (see "Precautions").
Blood and lymphatic system disorders: Frequent occurrences of thrombocytopenia, rare cases of anaemia, leucopenia or pancytopenia have been reported.
Isolated reduction of fibrinogen or increase in bleeding time has been reported, usually without associated clinical signs and particularly with high doses (sodium valproate has an inhibitory effect on the second phase of platelet aggregation) (see also "Pregnancy under Use in Pregnancy & Lactation").
Skin and subcutaneous tissue disorders: The following side-effects have been reported and the frequencies are unknown: Cutaneous reactions may occur with valproate such as exanthematous rash. In exceptional cases, toxic epidermal necrolysis, Stevens-Johnson syndrome and erythema multiforme have been reported.
Transient and (or) dose related hair loss has often been reported. Regrowth normally begins within six months, although the hair may become curlier than previously.
Reproductive system disorders: The following side-effects have been reported and the frequencies are unknown: Amenorrhoea and irregular periods have been reported.
Vascular disorders: The following side-effects have been reported and the frequencies are unknown: The occurrence of vasculitis has been reported.
Ear disorders: Hearing loss, either reversible or irreversible, has been reported rarely; however a cause and effect relationship has not been established.
Renal and urinary disorders: There have been isolated reports of a reversible Fanconi's syndrome (a defect in proximal renal tubular function) associated with valproate therapy but the mode of action is as yet unclear.
Immune system disorders: The following side-effects have been reported and the frequencies are unknown: Allergic reactions have been reported.
General disorders: Very rare cases of non-severe peripheral oedema have been reported. The following side-effects have been reported and the frequencies are unknown: Increase in weight may also occur. Weight gain being a risk factor for polycystic ovary syndrome, it should be carefully monitored (see "Precautions").
