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Description

Organ System Class (MedDRA) Frequency unknown (frequency cannot be determined from available data) Blood and lymphatic system disorders Agranulocytosis, thrombocytopenia, eosinophilia, leukopenia, anemia Immune system disorders Allergic reactions Endocrine system disorders Syndrome of inappropriate antidiuretic hormone secretion (SIADH) Metabolic and nutritional disorders Hyponatremia1, weight loss, anorexia, increased appetite Mental disorders Suicidal thoughts or behavior2, confusion, insomnia, disorientation, mania, anxiety, nervousness, agitation (very rarely worsening to episodes of delirium), delirium, aggressive reaction, hallucinations, nightmares, decreased libido, withdrawal syndrome Nervous system disorders Serotonin syndrome, seizures, neuroleptic malignant syndrome, dizziness, vertigo, headache, somnolence3, restlessness, decreased alertness, tremor, visual impairment, memory impairment, myoclonic seizures, severe aphasia, paresthesia, dystonia, taste changes Cardiac disorders Cardiac arrhythmia4 (including polymorphic ventricular tachycardia), palpitations, premature ventricular contractions, two consecutive sets of premature ventricular contractions, ventricular tachycardia, bradycardia, tachycardia, QT prolongation Vascular disorders Orthostatic hypotension, arterial hypertension, syncope Disorders of the respiratory system, chest and mediastinal organs Nasal congestion, shortness of breath Gastrointestinal disorders Nausea, vomiting, dry mouth, constipation, diarrhea, dyspepsia, abdominal pain, gastroenteritis, increased salivation, paralytic ileus Disorders of the liver and biliary tract Liver dysfunction (including jaundice and liver cell damage)5, intrahepatic cholestasis Skin and subcutaneous tissue disorders Skin rash, itching, hyperhidrosis Musculoskeletal and connective tissue disorders Limb pain, back pain, myalgia, arthralgia Renal and urinary tract disorders Urinary disorders Disorders of the genital organs and breast Priapism6 General and administration site disorders Weakness, swelling, flu-like symptoms, fatigue, chest pain, fever Laboratory and instrumental data Elevated levels of liver enzymes Interaction General The sedative effect of antipsychotics, hypnotics, sedatives, anxiolytics and antihistamines may be enhanced

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