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A potentially fatal symptom complex sometimes referred to as Neuroleptic Malignant SyndromeNMShas been reported in association with antipsychotic drugssee ADVERSE REACTIONSClinical manifestations of NMS are hyperpyrexiamuscle rigidityaltered mental statusincluding catatonic signsand evidence of autonomic instabilityirregular pulse or blood pressuretachycardiadiaphoresisand cardiac dysrhythmiasAdditional signs may include elevated creatine phosphokinasemyoglobinuriarhabdomyolysisand acute renal failure.

If a patient requires antipsychotic drug treatment after recovery from NMSthe potential reintroduction of drug therapy should be carefully consideredThe patient should be carefully monitoredsince recurrences of NMS have been reported.

Because clinical trials are conducted under widely varying conditionsadverse reaction rates observed in the clinical trials of a drugcannot be directly compared to rates in the clinical trials of another drugand may not reflect the rates observed in practice.

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