Adverse Drug Reactions

Clinically significant adverse reactions

  1. 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.

 

  1. Urinary retention (frequency unknown) Since urinary retention may occur, patients should be monitored carefully. When symptoms are observed, administration should be discontinued, and appropriate measures should be taken.

 

  1. Hepatic dysfunction (frequency unknown) Since hepatic dysfunction with increased AST(GOT), ALT(GPT) and bilirubin may occur, patients should be monitored carefully. When these abnormalities in laboratory test values are observed, administration should be discontinued, and appropriate measures should be taken immediately.

 

  1. Paralytic Ileus (frequency unknown) When symptoms including severe constipation and abdominal distention are observed, administration should be discontinued, and appropriate measures should be taken.

 

  1. Hallucination/delirium (frequency unknown) When these symptoms are observed, administration should be discontinued, and appropriate measures should be taken.

 

  1. QT prolongation, ventricular tachycardia (frequency unknown) It has been reported that QT prolongation, ventricular tachycardia, atrioventricular block, bradycardia, etc. occur. When these symptoms are observed, administration should be discontinued, and appropriate measures should be taken.

 

Other adverse reactions

≥ 5% 5%> to ≥ 0.1% Unknown
Hypersensitivity Rash, itching, etc
Psychoneurologic Sleepiness, dysgeusia, dizziness, headache Numbness
Gastrointestinal Constipation Stomach discomfort/ abdominal discomfort, nausea, abdominal pain, abdominal distention, diarrhea, anorexia, dyspepsia, gastritis, vomiting, dry lip, abnormal faeces, stomatitis
Cardiovascular Palpltations, extra systoles, increased blood pressure
Respiratory Pharyngolaryngeal pain, cough, dry throat, hoarseness
Hematologic Decreased RBC, decreased WBC,
decreased platelets
Renal/urinary Dysuria, residual urine, positive WBC and RBC in urine, urinary tract infections (cystitis, pyelonephritis, etc.) , positive protein in urine, increased creatinine
Ophthalmologic Photophobia, blurred vision, abnormal sensation in eye, xerophthalmia, asthenopia, eyelid edema, diplopia
Hepatic Increased y-GTP, increased ALP, increased AST (GOT), increased ALT (GPT), increased bilirubin
Others Thirst/dry mouth
(33.1%)
Increased triglyceride, edema, increased LDH, increased blood uric acid, malaise, increased cholesterol, chest pain, back pain, feeling of weakness, dry skin

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

Seek medical attention immediately at the first sign of any adverse drug reaction.