Adverse Drug Reactions

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
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
Cardiovascular Hypotension Hypertension, orthostatic
Respiratory Dyspnea
Gastrointestinal Nausea, constipation Dyspepsia, gastritis, vomiting Abdominal discomfort,
abdominal pain, diarrhea,
Dermatologic Erythema, hyperhidrosis,
photosensitivity reaction
Musculoskeletal Back pain, abnormal posture, spinal osteoarthritis Arthralgia, muscle rigidity,
muscle spasms
General symptom Fall Gait disturbance, oedema
peripheral, thirst
Asthenia, condition
aggravated, fatigue, malaise
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: