Rexulti Adverse Reactions

The following adverse reactions are discussed in more detail in other sections of the monograph: Increased Mortality in Elderly Patients with Dementia-Related Psychosis [see Warnings, Increased Mortality in Elderly Patients with Dementia-Related Psychosis under Precautions].
Suicidal Thoughts and Behaviors [see Suicidal Thoughts and Behaviors under Precautions].
Cerebrovascular Adverse Reactions Including Stroke in Elderly Patients with Dementia-Related Psychosis [see Cerebrovascular Adverse Reactions Including Stroke in Elderly Patients with Dementia-Related Psychosis under Precautions].
QT prolongation [see QT Prolongation under Precautions].
Venous thromboembolism [see Venous Thromboembolism under Precautions].
Neuroleptic Malignant Syndrome (NMS) [see Neuroleptic Malignant Syndrome (NMS) under Precautions].
Tardive Dyskinesia [see Tardive Dyskinesia under Precautions].
Metabolic Changes [see Metabolic Changes under Precautions].
Pathological Gambling and Other Compulsive Behaviors [see Pathological Gambling and Other Compulsive Behaviors under Precautions].
Leukopenia, Neutropenia, and Agranulocytosis [see Leukopenia, Neutropenia, and Agranulocytosis under Precautions].
Orthostatic Hypotension and Syncope [see Orthostatic Hypotension and Syncope under Precautions].
Falls [see Falls under Precautions].
Seizures [see Seizures under Precautions].
Body Temperature Dysregulation [see Body Temperature Dysregulation under Precautions].
Dysphagia [see Dysphagia under Precautions].
Potential for Cognitive and Motor Impairment [see Potential for Cognitive and Motor Impairment under Precautions].
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.
The safety of REXULTI was evaluated in 852 patients (18 to 65 years of age) diagnosed with schizophrenia who participated in two 6-week, placebo-controlled, fixed-dose clinical trials in which REXULTI was administered at daily doses of 1 mg, 2 mg and 4 mg [see Pharmacology: Pharmacodynamics: Clinical Studies under Actions].
Common Adverse Reactions: Adverse reactions associated with REXULTI (incidence of 2% or greater and REXULTI incidence greater than placebo) during short-term (up to 6 weeks) trials in patients with schizophrenia are shown in Table 5. (See Table 5.)


Click on icon to see table/diagram/image


Extrapyramidal Symptoms: The incidence of reported EPS-related adverse reactions, excluding akathisia, was 5% for REXULTI-treated patients versus 4% for placebo-treated patients. The incidence of akathisia events for REXULTI-treated patients was 6% versus 5% for placebo-treated patients.
In the 6-week, placebo-controlled, fixed-dose schizophrenia studies, data was objectively collected on the Simpson Angus Rating Scale (SAS) for extrapyramidal symptoms (EPS), the Barnes Akathisia Rating Scale (BARS) for akathisia and the Abnormal Involuntary Movement Scale (AIMS) for dyskinesia. The mean change from baseline at last visit for REXULTI-treated patients for the SAS, BARS and AIMS was comparable to placebo-treated patients. The percentage of patients who shifted from normal to abnormal was greater in REXULTI-treated patients versus placebo for the BARS (2% versus 1%) and the SAS (7% versus 5%).
Dystonia: Symptoms of dystonia may occur in susceptible individuals during the first few days of treatment. Dystonic symptoms include: spasm of the neck muscles, sometimes progressing to tightness of the throat, swallowing difficulty, difficulty breathing, and/or protrusion of the tongue. While these symptoms can occur at low doses, they occur more frequently and with greater severity with high potency and at higher doses of first generation antipsychotic drugs. An elevated risk of acute dystonia is observed in males and younger age groups.
Other Adverse Reactions Observed During the Premarketing Evaluation of REXULTI: Other adverse reactions (≥ 1% frequency and greater than placebo) within the short-term, placebo-controlled trials are shown as follows. The following listing does not include adverse reactions: 1) already listed in previous tables or elsewhere in the labeling, 2) for which a drug cause was remote, 3) which were so general as to be uninformative, 4) which were not considered to have clinically significant implications, or 5) which occurred at a rate equal to or less than placebo.
Eye Disorders: Vision Blurred.
Gastrointestinal Disorders: Nausea, Dry Mouth, Salivary Hypersecretion, Abdominal Pain, Flatulence.
Infections and Infestations: Urinary Tract Infection.
Investigations: Blood Prolactin Increased.
Musculoskeletal and Connective Tissue Disorders: Myalgia.
Psychiatric Disorders: Abnormal Dreams, Insomnia.
Skin and Subcutaneous Tissue Disorders: Hyperhidrosis.
Postmarketing Experience: The following adverse reaction has been identified during post-approval use of REXULTI. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Nervous System disorders: Neuroleptic Malignant Syndrome.