At a glance
What is it—and why does it matter?
Terlipressin is described chemically as a peptide composed of 12 amino acids. The product’s active ingredient, terlipressin, is classified as a vasopressin receptor agonist (i.e., it binds to and activates vasopressin receptors). In the labeled indication, terlipressin (TERLIVAZ) is indicated for improving renal function in adults with hepatorenal syndrome associated with rapid reduction in kidney function. A labeled warning for terlipressin notes risk of severe respiratory failure, including fatal cases.
Sources for this introduction: [1] [2] [3] [4]
This published profile is a reference in progress. Findings retain their source context; missing topics are marked below.
What is it?
A molecule, not a product name.
Identity
Terlipressin is described chemically as a peptide composed of 12 amino acids.
- Source records
- 2
- Independent studies
- 1
- Regulatory records
- 1
Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.
Exact passages, locators, and provenance
- supports · Source-backed record
“Terlipressin is a 12-amino acid peptide with the chemical nameN-[N-(N-glycylglycyl)glycyl]-8-L-lysinevasopressin.”
These highlights do not include all the information needed to use TERLIVAZ®safely and effectively. See full prescribing information for TERLIVAZ.TERLIVAZ (terlipressin) for injection, for intravenous useInitial U.S. Approval: 2022 · 11 DESCRIPTION
dailymed:3a35b86c-f451-4fac-8499-43019e4da354:d3cf759c2742:d3cf759c2742 - supports · Source-backed record
“Terlipressin is a synthetic vasopressin analogue”
Evaluation of Terlipressin and In-Hospital Mortality in the Treatment of Hepatorenal Syndrome-Acute Kidney Injury (HRS-AKI). · BACKGROUND
pubmed:42500941:016633ebe7d5:016633ebe7d5
How does it work?
Target, response, and disposition.
Mechanism
The product’s active ingredient, terlipressin, is classified as a vasopressin receptor agonist (i.e., it binds to and activates vasopressin receptors).
- Source records
- 1
- Regulatory records
- 1
Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.
Exact passages, locators, and provenance
- supports · Source-backed record
“TERLIVAZ contains terlipressin, a vasopressin receptor agonist.”
These highlights do not include all the information needed to use TERLIVAZ®safely and effectively. See full prescribing information for TERLIVAZ.TERLIVAZ (terlipressin) for injection, for intravenous useInitial U.S. Approval: 2022 · 11 DESCRIPTION
dailymed:3a35b86c-f451-4fac-8499-43019e4da354:d3cf759c2742:d3cf759c2742
What has been studied?
What the evidence says.
Study findings
In the labeled indication, terlipressin (TERLIVAZ) is indicated for improving renal function in adults with hepatorenal syndrome associated with rapid reduction in kidney function.
- Source records
- 1
- Regulatory records
- 1
Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.
Exact passages, locators, and provenance
- supports · Source-backed record
“TERLIVAZ is indicated to improve kidney function in adults with hepatorenal syndrome with rapid reduction in kidney function.”
These highlights do not include all the information needed to use TERLIVAZ®safely and effectively. See full prescribing information for TERLIVAZ.TERLIVAZ (terlipressin) for injection, for intravenous useInitial U.S. Approval: 2022 · 1 INDICATIONS AND USAGE
dailymed:3a35b86c-f451-4fac-8499-43019e4da354:d3cf759c2742:d3cf759c2742
Risks and interactions
Risks, organized for scanning.
Contraindications
Per labeled contraindications, terlipressin should not be used in patients with hypoxia or worsening respiratory symptoms.
- Source records
- 1
- Regulatory records
- 1
Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.
Exact passages, locators, and provenance
- supports · Source-backed record
“TERLIVAZ is contraindicated in patients experiencing hypoxia or worsening respiratory symptoms.”
These highlights do not include all the information needed to use TERLIVAZ®safely and effectively. See full prescribing information for TERLIVAZ.TERLIVAZ (terlipressin) for injection, for intravenous useInitial U.S. Approval: 2022 · 4 CONTRAINDICATIONS
dailymed:3a35b86c-f451-4fac-8499-43019e4da354:d3cf759c2742:d3cf759c2742
Safety findings
A labeled warning for terlipressin notes risk of severe respiratory failure, including fatal cases.
- Source records
- 1
- Regulatory records
- 1
Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.
Exact passages, locators, and provenance
- supports · Source-backed record
“TERLIVAZ may cause serious or fatal respiratory failure.”
These highlights do not include all the information needed to use TERLIVAZ®safely and effectively. See full prescribing information for TERLIVAZ.TERLIVAZ (terlipressin) for injection, for intravenous useInitial U.S. Approval: 2022 · WARNING: SERIOUS OR FATAL RESPIRATORY FAILURE
dailymed:3a35b86c-f451-4fac-8499-43019e4da354:d3cf759c2742:d3cf759c2742
Safety findings
The label indicates that pediatric safety and efficacy data are insufficient to establish use in pediatric patients.
- Source records
- 1
- Regulatory records
- 1
Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.
Exact passages, locators, and provenance
- supports · Source-backed record
“Safety and effectiveness of TERLIVAZ have not been established in pediatric patients.”
These highlights do not include all the information needed to use TERLIVAZ®safely and effectively. See full prescribing information for TERLIVAZ.TERLIVAZ (terlipressin) for injection, for intravenous useInitial U.S. Approval: 2022 · 8.4 Pediatric Use
dailymed:3a35b86c-f451-4fac-8499-43019e4da354:d3cf759c2742:d3cf759c2742
Products and regulatory status
Same ingredient. Different records.
This profile does not yet contain a published summary for this topic. This is a coverage gap, not evidence that no research exists.
Administration context
The practical clinical context.
Administration
For preparation of terlipressin injection, each vial is reconstituted with 5 mL 0.9% sodium chloride, yielding a concentration of 0.85 mg per 5 mL.
- Source records
- 1
- Regulatory records
- 1
Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.
Exact passages, locators, and provenance
- supports · Source-backed record
“Reconstitute each vial with 5 mL of 0.9% Sodium Chloride Injection to prepare a 0.85 mg/5 mL solution.”
These highlights do not include all the information needed to use TERLIVAZ®safely and effectively. See full prescribing information for TERLIVAZ.TERLIVAZ (terlipressin) for injection, for intravenous useInitial U.S. Approval: 2022 · 2.3 Preparation and Administration
dailymed:3a35b86c-f451-4fac-8499-43019e4da354:d3cf759c2742:d3cf759c2742
Dose records
Recommended initiation dosing for terlipressin (TERLIVAZ) is 0.85 mg q6h, administered as a slow IV bolus over 2 minutes for the first 3 days.
- Source records
- 1
- Regulatory records
- 1
Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.
Exact passages, locators, and provenance
- supports · Source-backed record
“The recommended starting dosage is TERLIVAZ 0.85 mg every 6 hours by slow intravenous bolus injection (over 2 minutes) on Days 1 through 3.”
These highlights do not include all the information needed to use TERLIVAZ®safely and effectively. See full prescribing information for TERLIVAZ.TERLIVAZ (terlipressin) for injection, for intravenous useInitial U.S. Approval: 2022 · 2.2 Recommended Dosage
dailymed:3a35b86c-f451-4fac-8499-43019e4da354:d3cf759c2742:d3cf759c2742
Research status + gaps
What still needs better answers?
- No publishable claim yet for: interaction, regulatory
- 14 compiled claim(s) withheld by automated assurance: assurance_score_below_0.58 (11), assurance_score_below_0.72 (2), current_regulatory_source_required (1), extraction_ambiguity (8), extraction_confidence_not_high (5), high_risk_requires_regulatory_or_two_independent_sources (3), no_direct_support (13)
These are the limits of this profile, not an exhaustive list of scientific uncertainties.
References + discovery
Open the records yourself.
- These highlights do not include all the information needed to use TERLIVAZ®safely and effectively. See full prescribing information for TERLIVAZ.TERLIVAZ (terlipressin) for injection, for intravenous useInitial U.S. Approval: 2022 ↗
dailymed · published 2026-06-19 · retrieved 2026-09-04T22:25:11Z
- Evaluation of Terlipressin and In-Hospital Mortality in the Treatment of Hepatorenal Syndrome-Acute Kidney Injury (HRS-AKI). ↗
pubmed · published 2026-07-25 · retrieved 2026-08-21T17:03:42Z
Publication history and provenance
Version 4 · Automated assessment · 2026-09-04T22:25:11Z
bae4f20dbf293565b1ff174bb71b45dcfe92a59bd5f130037ae8b112e41ce4cd