Epilepsan Adverse Reactions

valproic acid




Full Prescribing Info
Adverse Reactions
Side effects can be caused by Valproic Acid monotherapy or in combination.
Gastrointestinal: The most common side effects of Valproic Acid after initial therapy with this drug are nausea, vomiting, and indigestion. These side effects are usually temporary and rarely until the cessation of therapy. Diarrhea, stomach cramps and constipation have been reported. Anorexia with weight loss and increased appetite accompanied by weight gain was also reported.
Central nervous system: The effect of sedation has been reported to occur with a single use of Valproic Acid but has been reported to occur more frequently in patients receiving the combination. Sedation is usually reduced if antiepileptic drugs are reduced. Tremors have been reported inpatients receiving valproate and may be dose dependent. Ataxia, headaches, nystagmus, diplopia, asterixis, "spot before eyes" dysarthria, dizziness and incoordination have been reported to be rare. Coma has been reported in patients receiving Valproic Acid as monotherapy or in combination with Phenobarbital.
Dermatology: An increase in temporary hair loss has been reported. Photosensitivity skin rash, generalized pruritus, erythema multiforme and Stevens-Johnson syndrome are rarely reported.
Psychiatry: Emotional disorders, depression, psychosis, aggression, hyperactivity, and destructive behavior have been reported.
Musculoskeletal: Weaknesses have been reported.
Hematology: Thrombocytopenia has been reported. Valproic Acid inhibits the platelet aggregation phase. This can cause changes in bleeding time. Petechiae, bruising, hematoma formation and hemorrhage have been reported (see Warnings and Precautions).
Lymphocytosis and hypofibrinogemia have been recorded. Leukopenia, esonophilia, anemia, and bone marrow suppression have been reported.
Hepatic: Slight increases in serum concentrations of transaminases (such as SGPT and SGOT) and LDH (lactate dehydrogenase) are often reported to occur and are likely to be dose dependent. Occasionally, laboratory test results include an increase in serum bilirubin and abnormal changes in other liver function tests. These results can illustrate the possibility of serious hepatotoxicity (see Warnings and Precautions).
Endocrine: Irregular menstruation and secondary amenorrhea have been reported. Rarely, breast enlargement and galactorrhea are reported in patients receiving Valproic acid. Abnormal thyroid function tests have been reported.
Pancreatic: Acute pancreatitis, including rare fatal cases, has been reported in patients using Valproic Acid.
Metabolic: Hyperammonemia (see Warnings and Precautions), hyperglycinemiahas been reported and is associated with fatal events in patients with preexistent non ketonic hyperglycinemial.
Others: Edema in extremities has been reported.
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