Equfina Adverse 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 [see IMPORTANT PRECAUTIONS under Precautions].
Impulse-control disorder (0.2%): Impulse-control disorder including pathological gambling, pathological hypersexuality, compulsive shopping, or hyperphagia may occur [see IMPORTANT PRECAUTIONS].
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: (See Table 6.)

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Urinary tract infection (frequency unknown): Urinary tract infection was observed in a long-term open-label study.