The following adverse reactions may occur. Therefore, patients should be closely monitored, and if any abnormal findings are observed, appropriate measures including discontinuation of this drug should be taken.
Clinically Significant Adverse Reactions
Psychiatric symptoms such as hallucination
Visual hallucinations (3.2%), hallucination (1.1%), or other symptoms may occur.
Somnolence (1.9%), sudden onset of sleep (0.4%)
Daytime somnolence or sudden onset of sleep with no signs may occur.
Impulse-control disorder (0.2%)
Impulse-control disorder including pathological gambling, pathological hypersexuality, compulsive shopping, or hyperphagia may occur.
Serotonin syndrome (frequency unknown)
If any of symptoms of serotonin syndrome, such as anxiety, restlessness, excitement, confusion, fever, myoclonus, sweating, and tachycardia, is observed, treatment with this drug should be discontinued, systemic management such as cooling and fluid replacement should be initiated, and appropriate measures should be taken.
Neuroleptic malignant syndrome (frequency unknown)
Rapid dose reduction or discontinuation of this drug may cause high fever, consciousness disorder, severe muscle rigidity, involuntary movement, increased serum CK, or other related symptoms. If any of these symptoms is observed, systemic management such as cooling and fluid replacement should be initiated, and appropriate measures should be taken.
Other Adverse Reactions
| ≥5% | 1 to <5% | <1% | Frequency unknown | |
| Infections | Gingivitis, nasopharyngitis | Pneumonia | ||
| Hematologic | Anemia | |||
| Metabolism | Decreased appetite | |||
| Psychoneurologic | Dyskinesia (12.4%) |
Insomnia, headache, dizziness | Delirium, abnormal REM sleep, pleurothotonus, Parkinson’s disease, restless legs syndrome |
Agitation, anxiety, confusional state, depression, restlessness, akinesia, balance disorder, hyperkinesia, tremor |
| Sensory | Vertigo | Cataract, diplopia, blurred vision, reduced visual acuity, visual impairment |
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| Cardiovascular | Hypotension | Hypertension, orthostatic hypotension |
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| Respiratory | Dyspnea | |||
| Gastrointestinal | Nausea, constipation | Dyspepsia, gastritis, vomiting | Abdominal discomfort, abdominal pain, diarrhea, nausea |
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| Dermatologic | Erythema, hyperhidrosis, photosensitivity reaction |
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| Musculoskeletal | Back pain, abnormal posture, spinal osteoarthritis | Arthralgia, muscle rigidity, muscle spasms |
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| General symptom | Fall | Gait disturbance, oedema peripheral, thirst |
Asthenia, condition aggravated, fatigue, malaise |
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| Laboratory test | ALT increased | AST increased, ALP increased, γ-GTP increased, blood potassium increased, glucose urine present, decreased blood pressure, weight decreased |
Blood pressure increased |
| Reporting of suspected adverse drug reactions |
| Please contact: |
| HI-Eisai Pharmaceutical, Inc. |
| +63 2 88875837 / +63 2 88875160 / +63 9088672236 |
| Or Report to FDA Philippines: www.fda.gov.ph |
