Uritos Adverse Reactions

Adverse reactions to this product including abnormalities in laboratory test values were reported in 533 (45.5%) of 1,172 cases evaluated. Major adverse reactions included thirst in 368 cases (31.4%), constipation in 98 cases (8.4%), photophobia in 18 cases (1.5%), blurred vision in 16 cases (1.4%), sleepiness in 16 cases (1.4%), stomach discomfort in 13 cases (1.1%), increased triglyceride in 13 cases(1.1%), and increased γ-GTP in 12 cases (1.0%) (at the time of approval).
Clinically Significant Adverse Reaction: Acute Glaucoma (Incidence: 0.06%): Since incidence of acute glaucoma induced by increased intraocular pressure has been reported, patients should be monitored carefully. When such a symptom is observed, administration should be discontinued, and appropriate measures should be taken immediately.
Urinary Retention (Frequency Unknown: Based on Spontaneous Reporting): Since urinary retention may occur, patients should be monitored carefully. When symptoms are observed, administration should be discontinued, and appropriate measures should be taken.
Clinically Significant Adverse Reactions (Similar Drugs): Ileus Paralytic: Since incidence of ileus paralytic has been reported in the similar drugs (other agents for overactive bladder), patients should be monitored carefully. When symptoms including severe constipation and abdominal distention are observed, administration should be discontinued, and appropriate measures should be taken.
Hallucination/Delirium: Since incidence of hallucination/delirium has been reported in the similar drugs (other agents for overactive bladder), patients should be monitored carefully. When these symptoms are observed, administration should be discontinued, and appropriate measures should be taken.
QT Prolongation, Ventricular Tachycardia: Since incidence of symptoms including QT prolongation, ventricular tachycardia, atrioventricular block, and bradycardia has been reported in the similar drugs (other agents for overactive bladder), patients should be monitored carefully. When these symptoms are observed, administration should be discontinued, and appropriate measures should be taken.
Other Adverse Reactions: (See Table 8.)

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Inform the physician in case of any adverse reactions related to drug use.