Out of 13,226 patients examined for Uralyt-U [in clinical trials for new drug application (NDA) and post-marketing studies for re-evaluation] and Xitrin (in clinical trials for NDA), adverse reactions (including abnormal changes of laboratory test values) were observed in 192 (1.45%) patients. Most frequently reported adverse reactions were gastrointestinal symptoms (0.6%) eg, diarrhea and loose stools (20 events); stomach discomfort (15 events); and nausea (10 events). Main abnormal changes in laboratory test value were serum potassium elevation (28 events); GPT elevation (23 events); and GOT elevation (18 events).
Incidence of adverse reactions:
Abnormality of Metabolism:
0.1-1%: Increased GOT, GPT. <1%: Increased ALP, γ-GPT, LDH.
<1%: Increased blood creatinine, BUN.
0.1-1%: Stomach discomfort, diarrhea. <1%: Anorexia, retching, nausea, vomiting, heartburn, stomatitis, abdominal distention.
<1%: Rash, itching.
<1%: Urinary disorder. The cause is incarceration of shrunk calculus into the urinary duct. In such case, an appropriate measure including surgical measure should be taken.
<1%: Tachycardia, feeling of residual urine, sleepiness, anemia, malaise.
*Careful monitoring should be performed during treatment and if any abnormality was observed; appropriate measure eg, a decrease in dosage or Xitrin discontinuation should be considered.