Table 19: Incidence of EPS Compared to Placebo in the Adjunctive Therapy Bipolar Depression Studies Adverse Event Term Placebo LATUDA 20 to (N=334) 120 mg/day (%) (N=360)(%) All EPS events 13 24 Ail EPS events, 9 14 excluding Akathisia/Restlessness Akathisia 5 11 Dystonia* 1 1 Parkinsonism** 8 13 Restlessness 1 4 Note: Figures rounded to the nearest integer *Dystonia includes adverse event terms: dystonia, oculogyric crisis, oromandibular dystonia, tongue spasm, torticollis, and trismus **Parkinsonism includes adverse event terms: bradykinesia, cogwheel rigidity, drooling, extrapyramidal disorder
, glabellar reflex abnormal, hypokinesia, muscle rigidity, parkinsonism, psychomotor retardation, and tremor
The most common adverse reactions in clinical trials in patients with schizophrenia ([greater than or equal to]5% and twice placebo) were injection site reactions, somnolence/sedation, dizziness, akathisia and extrapyramidal disorder
The most common treatment-emergent adverse events (TEAEs)(3), that occurred at a rate of 10 percent or more were: extrapyramidal disorder
(movement disorder) (25%), insomnia (14%), headache (12%), and akathisia (restlessness) (11%).
The most common adverse events were akathisia, extrapyramidal disorder
, tremor, dyspepsia, and vomiting.
Cariprazine was generally well tolerated with the most common adverse events (10%) observed in any treatment group being akathisia, headache, insomnia, restlessness, and extrapyramidal disorder
adverse reactions, defined by at least a 5% incidence and twice that of placebo, are injection site reactions, somnolence/sedation, dizziness, akathisia and extrapyramidal disorder
The most commonly reported adverse reactions (5% and twice placebo), which were predominantly mild to moderate in severity, were akathisia, extrapyramidal disorder
, dyspepsia, restlessness, tremor, fatigue and vomiting.
Across the cariprazine treated group, the most common adverse events (incidence >/=5% and greater than placebo) were nasopharyngitis, tremor, extrapyramidal disorder
, akathisia, back pain, and blood creatine phosphokinase increased.
The most common adverse events (AEs) observed in any cariprazine dose group were insomnia, extrapyramidal disorder
, akathisia, sedation, nausea, dizziness, and constipation.
, musculoskeletal stiffness, muscle rigidity, and bradykinesia
The most common side effects that occurred with INVEGA(R) were restlessness and extrapyramidal disorder
(for example, involuntary movements, tremors and muscle stiffness).
ADULTS: Nausea, vomiting, constipation, headache, dizziness, an inner sense of restlessness or need to move (akathisia), anxiety, insomnia, and restlessness -- PEDIATRIC PATIENTS (10 to 17 years): Extrapyramidal disorder
(for example, uncontrolled movement disorders or muscle disturbances such as restlessness, tremors and muscle stiffness), headache, sleepiness, and nausea