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MedDRA terminology has been used to classify the adverse events.
Human Experience: A total of 76 cases of deliberate or accidental overdosage with aripiprazole have been reported worldwide. These include overdoses with aripiprazole alone and in combination with other substances. No fatality was reported from these cases. Of the 44 cases with known outcome, 33 recovered without sequelae and 1 recovered with sequelae (mydriasis and feeling abnormal). The largest known acute ingestion with a known outcome involved 1080 mg of aripiprazole (36 times the maximum recommended daily dose) in a patient who fully recovered. Included in the 76 cases are 10 cases of deliberate or accidental overdosage in children (≤12 years) involving aripiprazole ingestions up to 195 mg with no fatalities.
Symptoms: Common adverse events (reported in at least 5% of all overdose cases) reported with aripiprazole overdosage (alone or in combination with other substances) include vomiting, somnolence and tremor. Other clinically important signs and symptoms observed in ≥1 patients with aripiprazole overdoses (alone or with other substances) include acidosis, aggression, increased aspartate aminotransferase, atrial fibrillation, bradycardia, coma, confusional state, convulsion, increased blood creatine phosphokinase, depressed level of consciousness, hypertension, hypokalaemia, hypotension, lethargy, loss of consciousness, prolonged QRS complex, prolonged QT, aspiration pneumonia, respiratory arrest, status epilepticus and tachycardia.
Treatment: No specific information is available on the treatment of overdose with aripiprazole. An electrocardiogram should be obtained in case of overdosage and, if QTc interval prolongation is present, cardiac monitoring should be instituted. Otherwise, management of overdose should concentrate on supportive therapy, maintaining an adequate airway, oxygenation and ventilation, and management of symptoms. Close medical supervision and monitoring should continue until the patient recovers.
Charcoal: In the event of an overdose of Abilify, an early charcoal administration may be useful in partially preventing the absorption of aripiprazole. Administration of activated charcoal 50 g, 1 hr after a single 15-mg oral dose of aripiprazole, decreased the mean AUC and Cmax of aripiprazole by 50%.
Hemodialysis: Although there is no information on the effect of hemodialysis in treating an overdose with aripiprazole, hemodialysis is unlikely to be useful in overdose management since aripiprazole is highly bound to plasma proteins.
