Livact Adverse Reactions

Among 2898 patients studied in clinical trials conducted prior to application for approval and in post-marketing drug use investigations, 249 adverse reactions were reported in 169 cases (5.8%). Major adverse reactions included sensation of abdominal bloating (18 cases, 0.6%), retching/nausea (17 cases, 0.6%), diarrhea (16 cases, 0.6%), elevation in blood urea nitrogen (15 cases, 0.5%), and increased blood ammonia (15 cases, 0.5%). (At the 4th Periodic Safety Update Reporting.)
Gastrointestinal¹: 0.1 to <5%: Abdominal distension, queasy , diarrhoea, constipation, abdominal discomfort, abdominal pain, vomiting, anorexia, heartburn, etc. <0.1%: Thirst, eructation.
Renal¹: 0.1 to <5%: Increased BUN and serum creatinine, etc.
Metabolism¹: 0.1 to <5%: Increased blood ammonia, etc.
Hepatic: 0.1 to <5%: Increased serum AST (GOT), serum ALT (GPT), total bilirubin, etc.
Skin: 0.1 to <5%: Rash, itching, etc.
Others: 0.1 to <5%: Malaise, oedema (facial, lower leg, etc.). Frequency Unknown: Redness, hot flush.
¹The dose should be reduced or administration temporarily discontinued in the event that any abnormality is observed.