Lurasitor 40/Lurasitor 80 Adverse Reactions

Somnolence, akathisia, extrapyramidal symptoms, nausea, omitting, diarrhea and anxiety: Somnolence includes adverse event terms: hypersomnia, hypersomnolence, sedation and somnolence; extrapyramidal symptoms include adverse event terms: bradykinesia, cogwheel rigidity, drooling, dystonia (dystonia, oculogyric crisis, oromandibular dystonia), parkinsonism (hypokinesia, muscle rigidity), psychomotor retardation, tongue spasms, torticollis, tremor and trismus.
The following adverse reactions are discussed in more detail under Precautions: Increased mortality in elderly patients with dementia-related psychosis; suicidal thoughts and behavior; cerebrovascular adverse reactions, including stroke, in elderly patients with dementia-related psychosis; neuroleptic malignant syndrome; tardive dyskinesia; metabolic changes; hyperprolactinemia; leukopenia, neutropenia, and agranulocytosis; orthostatic hypotension and syncope; falls; seizures; potential for cognitive and motor Impairment; body temperature dysregulation; activation of mania/hypomania; dysphagia; neurological adverse reactions in patients with parkinson's disease or dementia with lewy bodies.
Adverse Reactions Observed During the Premarketing Evaluation of Lurasidone Hydrochloride: Following is a list of adverse reactions reported by adult patients treated with lurasidone hydrochloride at multiple doses of ≥20 mg once daily within the premarketing database of patients with schizophrenia. The reactions listed are those that could be of clinical importance, as well as reactions that are plausibly drug-related on pharmacologic or other grounds.
Reactions are further categorized by organ class and listed in order of decreasing frequency according to the following definitions: those occurring in at least 1/100 patients (frequent) (only those not already listed in the tabulated results from placebo-controlled studies appear in this listing); those occurring in 1/100 to 1/1000 patients (infrequent); and those occurring in fewer than 1/1000 patients (rare). (See Table 1.)

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