Adverse events of terlipressin in liver cirrhosis with acute gastrointestinal bleeding: a clinical pharmacist’s real-world observational study

Background: Terlipressin is the first-line treatment for the management of acute gastro-esophageal variceal bleeding and hepatorenal syndrome in liver cirrhosis. However, the incidence, characteristics, and outcomes of terlipressin related adverse events have not been defined. Methods: We retrospectively reviewed all patients with cirrhosis and acute gastrointestinal bleeding who were treated with terlipressin at our department between January and March 2018. Except for the dose and duration of terlipressin, a clinical pharmacist observed and recorded the type, intervention, and outcomes of adverse events during terlipressin every day. Results: A total of 24 patients were investigated. The incidence of adverse events during terlipressin was 50.0%. There were eight types of adverse events observed. Grade of adverse events was mild or moderate in most of patients. No lethal adverse event was observed. Six patients (25.0%) developed serum sodium concentration reduction. Two patients (8.3%) developed hyponatremia, in both of whom spontaneous resolution was achieved in the absence of any intervention. One patient developed tachycardia, in whom spontaneous resolution was achieved in the absence of any intervention. One patient developed abdominal pain, which was spontaneously resolved after the cessation of terlipressin. Conclusions: In our everyday clinical practice, terlipressin related adverse events are common, but often reversible. Further large scale observational studies should be necessary to confirm our findings.