Active substance
Terlipressin
- US FDA 1
- Safety 1
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| TERLIVAZ | EQ 0.85MG BASE/VIAL | powder · intravenous | MALLINCKRODT IRELAND | Prescription | 14 Sep 2022 |
Safety signals and safety-related labeling changes
- MHRA 23 Mar 2023 Terlipressin: new recommendations to reduce risks of respiratory failure and septic shock in patients with type 1 hepatorenal syndrome
New recommendations following a recent clinical trial which found that in patients with type 1 hepatorenal syndrome terlipressin may cause serious or fatal respiratory failure at a frequency higher than previously known, and that terlipressin increases the risk of sepsis and septic shock.
Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.