Lurasidone Hydrochloride Side Effects

6 ADVERSE REACTIONS The following adverse reactions are discussed in more detail in other sections of the labeling: • Increased Mortality in Elderly Patients with Dementia-Related Psychosis [see Boxed Warning and Warnings and Precautions ( 5.1 )] • Suicidal Thoughts and Behaviors [see Boxed Warning and Warnings and Precautions ( 5.2 )] • Cerebrovascular Adverse Reactions, Including Stroke, in Elderly Patients with Dementia-related Psychosis [see Warnings and Precautions ( 5.3 )] • Neuroleptic Malignant Syndrome [see Warnings and Precautions ( 5.4 )] • Tardive Dyskinesia [see Warnings and Precautions ( 5.5 )] • Metabolic Changes [see Warnings and Precautions ( 5.6 )] • Hyperprolactinemia [see Warnings and Precautions ( 5.7 )] • Leukopenia, Neutropenia, and Agranulocytosis [see Warnings and Precautions ( 5.8 )] • Orthostatic Hypotension and Syncope [see Warnings and Precautions ( 5.9 )] • Falls [see Warnings and Precautions ( 5.10 )] • Seizures [see Warnings and Precautions ( 5.11 )] • Potential for Cognitive and Motor Impairment [see Warnings and Precautions ( 5.12 )] • Body Temperature Dysregulation [see Warnings and Precautions ( 5.13 )] • Activation of Mania/Hypomania [see Warnings and Precautions ( 5.14 )] • Dysphagia [see Warnings and Precautions ( 5.15 )] • Neurological Adverse Reactions in Patients with Parkinson’s Disease or Dementia with Lewy Bodies [see Warnings and Precautions ( 5.16 )] Commonly observed adverse reactions (incidence ≥ 5% and at least twice the rate for placebo) were ( 6.1 ): • Adult patients with schizophrenia: somnolence, akathisia, extrapyramidal symptoms, and nausea • Adolescent patients (13 to 17 years) with schizophrenia: somnolence, nausea, akathisia, EPS (non-akathisia), rhinitis (80 mg only), and vomiting • Adult patients with bipolar depression: akathisia, extrapyramidal symptoms, and somnolence • Pediatric patients (10 to 17 years) with bipolar depression: nausea, weight increase, and insomnia.

To report SUSPECTED ADVERSE REACTIONS, contact Annora Pharma Private Limited at 1-866-495-1995 or FDA at 1-800-FDA-1088 www.fda.gov/medwatch .

6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

Adults The information below is derived from an integrated clinical study database for lurasidone hydrochloride consisting of 3799 adult patients exposed to one or more doses of lurasidone hydrochloride for the treatment of schizophrenia, and bipolar depression in placebo-controlled studies.

This experience corresponds with a total experience of 1250.9 patient-years.

A total of 1106 lurasidone hydrochloride -treated patients had at least 24 weeks and 371 lurasidone hydrochloride-treated patients had at least 52 weeks of exposure.

Adverse events during exposure to study treatment were obtained by general inquiry and voluntarily reported adverse experiences, as well as results from physical examinations, vital signs, ECGs, weights and laboratory investigations.

Adverse experiences were recorded by clinical investigators using their own terminology.

In order to provide a meaningful estimate of the proportion of individuals experiencing adverse events, events were grouped in standardized categories using MedDRA terminology.

Schizophrenia The following findings are based on the short-term, placebo-controlled premarketing adult studies for schizophrenia in which lurasidone hydrochloride tablets were administered at daily doses ranging from 20 to 160 mg (n=1508).