Depakene Adverse Reactions

Since Depakene have usually been used with other antiepileptic drugs, it is not possible, in most cases, to determine whether the following adverse reactions can be attributed to Depakene alone or the combination of drugs.
Gastrointestinal: The most commonly reported adverse effects at the initiation of therapy are nausea, vomiting and indigestion. These effects are usually transient and rarely require discontinuation of therapy. Diarrhea, abdominal cramps and constipation have been reported. Both anorexia with some weight loss and increased appetite with weight gain have also been reported. Some patients experiencing gastrointestinal adverse effects may benefit by converting therapy from Depakene to Depakote.
The administration of enteric-coated sodium hydrogen divalproate may result in reduction of gastrointestinal side effects in some patients.
CNS Effects: Sedative effects have been noted in patients receiving valproic acid alone but are found most often in patients receiving combination therapy. Sedation usually disappears upon reduction of other antiepileptic medication. Tremor has been reported in patients receiving valproate and may be dose related. Ataxia, headache, nystagmus, diplopia, asterixis, "spots before eyes", dysarthria, dizziness and incoordination have rarely been noted. Rare cases of coma have been noted in patients receiving valproic acid alone or in conjunction with phenobarbital.
Dermatologic: Transient increases in hair loss have been observed. Skin rash and erythema multiforme and Stevens-Johnson syndrome have rarely been noted.
Psychiatric: Emotional upset, depression, psychosis, aggression, hyperactivity and behavioral deterioration have been reported.
Musculoskeletal: Weakness has been reported.
Hematologic: Thrombocytopenia has been reported. Valproic acid inhibits the secondary phase of platelet aggregation (see Interactions). This may be reflected in altered bleeding time. Petechiae, bruising, hematoma formation and frank hemorrhage have been reported (see Precautions). Relative lymphocytosis and hypofibrinogenemia have been noted. Leukopenia and eosinophilia have also been reported. Anemia and bone marrow suppression have been reported.
Hepatic: Minor elevations of transaminases (eg, SGOT and SGPT) and LDH are frequent and appear to be dose related. Occasionally, laboratory test results include, as well, increases in serum bilirubin and abnormal changes in other liver function tests. These results may reflect potentially serious hepatotoxicity. (See Warnings.)
Endocrine: There have been reports of irregular menses and secondary amenorrhea, and rare reports of breast enlargement and galactorrhea occurring in patients receiving Depakene. Abnormal thyroid function tests have been reported. (See Precautions.)
Pancreatic: There have been reports of acute pancreatitis, including rare fatal cases, occurring in patients receiving Depakene.
Metabolic: Hyperammonemia (see Precautions). Hyperglycinemia has been reported and has been associated with a fatal outcome in a patient with preexistent nonketotic hyperglycinemia.
Others: Edema of the extremities has been reported.