Terlipressin side effects: what 313 FDA adverse event reports show

Terlipressin · Terlivaz · 9 reaction terms · 101 drug–reaction co-reports · data 2026-09-14

Drug class

Vasopressin Receptor Agonist

FDA label (Established Pharmacologic Class)

Brand names

Terlivaz

openFDA label

Who reports

313 reports · 90% serious · 93 with death outcome · 36% female

openFDA FAERS counts, all years, deduplication not applied

Used for

TERLIVAZ is indicated to improve kidney function in adults with hepatorenal syndrome with rapid reduction in kidney function. Limitation of Use Patients with a serum creatinine > 5 mg/dL are unlikely to experience benefit. TERLIVAZ is a vasopressin receptor agonist indicated to improve kidney function in adults with hepatorenal syndrome with rapid reduction in kidney function.

FDA label, Indications and Usage

What it is

TERLIVAZ contains terlipressin, a vasopressin receptor agonist. Terlipressin is a 12-amino acid peptide with the chemical name N -[ N -( N -glycylglycyl)glycyl]-8-L-lysinevasopressin. The structure of terlipressin acetate is shown below:

FDA label, Description section

Boxed warning

SERIOUS OR FATAL RESPIRATORY FAILURE TERLIVAZ may cause serious or fatal respiratory failure. Patients with volume overload or with acute-on-chronic liver failure (ACLF) Grade 3 are at increased risk [see References (15) ]. Assess oxygenation saturation (e.g., SpO 2 ) before initiating TERLIVAZ.

FDA label

How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation. Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)? That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.

Causality screen of the 8 strongest signals

Not in label — unassessed 8

What the badges mean

Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.

Strongest disproportionality signals

Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 1 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.

Show: hide coding/lab/outcome terms hide indication terms unlabeled only hide PRR-only

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Hepatic encephalopathy	16	114.9 71.3–185.3ROR 121.1 · χ² 1,693 / p <1e-300	101.2 EB05 66.1 · IC025 +3.8 3/3 methods agree	Not in label — unassessed	serious PRR 73.3	no trial data cached
Ascites	22	50.1 33.5–75.0ROR 53.9 · χ² 1,012 / p 3e-222	48.1 EB05 33.5 · IC025 +3.9 3/3 methods agree	Not in label — unassessed	serious PRR 32.4 · ♀ 9% (drug 36%) · 100% clinician	no trial data cached
Multiple organ dysfunction syndrome	17	40.8 25.7–64.8ROR 43.1 · χ² 622 / p 1e-137	39.2 EB05 25.9 · IC025 +3.4 3/3 methods agree	Not in label — unassessed	serious PRR 26.0	no trial data cached
Electrocardiogram qt prolonged	17	31.7 19.9–50.3ROR 33.4 · χ² 475 / p 1e-105	30.7 EB05 20.3 · IC025 +3.3 3/3 methods agree	Not in label — unassessed	serious PRR 20.5	no trial data cached
Multi-organ failure	7	26.7 12.9–55.6ROR 27.3 · χ² 149 / p 2e-34	24.5 EB05 11.7 · IC025 +2.0 3/3 methods agree	Not in label — unassessed	serious PRR 17.0	no trial data cached
Lung infection	6	25.5 11.6–56.4ROR 26.0 · χ² 118 / p 9e-28	22.6 EB05 9.2 · IC025 +1.7 3/3 methods agree	Not in label — unassessed	serious PRR 17.4	no trial data cached
Eosinophilia	6	23.0 10.4–50.8ROR 23.4 · χ² 105 / p 5e-25	20.1 EB05 7.7 · IC025 +1.7 3/3 methods agree	Not in label — unassessed	serious PRR 15.3	no trial data cached
Myelosuppression	6	11.8 5.3–26.1ROR 12.0 · χ² 49 / p 1e-12	8.3 EB05 3.5 · IC025 +1.3 3/3 methods agree	Not in label — unassessed	serious PRR 7.5	no trial data cached

Trial evidence (ClinicalTrials.gov)

Trial cross-check not yet run for this drug (ClinicalTrials.gov pull covers the 800 most-reported drugs first).

Most frequently reported reactions

By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Ascites	22	50.1 33.5–75.0ROR 53.9 · χ² 1,012 / p 3e-222	48.1 EB05 33.5 · IC025 +3.9 3/3 methods agree	Not in label — unassessed	serious PRR 32.4 · ♀ 9% (drug 36%) · 100% clinician	no trial data cached
Electrocardiogram qt prolonged	17	31.7 19.9–50.3ROR 33.4 · χ² 475 / p 1e-105	30.7 EB05 20.3 · IC025 +3.3 3/3 methods agree	Not in label — unassessed	serious PRR 20.5	no trial data cached
Multiple organ dysfunction syndrome	17	40.8 25.7–64.8ROR 43.1 · χ² 622 / p 1e-137	39.2 EB05 25.9 · IC025 +3.4 3/3 methods agree	Not in label — unassessed	serious PRR 26.0	no trial data cached
Hepatic encephalopathy	16	114.9 71.3–185.3ROR 121.1 · χ² 1,693 / p <1e-300	101.2 EB05 66.1 · IC025 +3.8 3/3 methods agree	Not in label — unassessed	serious PRR 73.3	no trial data cached
Multi-organ failure	7	26.7 12.9–55.6ROR 27.3 · χ² 149 / p 2e-34	24.5 EB05 11.7 · IC025 +2.0 3/3 methods agree	Not in label — unassessed	serious PRR 17.0	no trial data cached
Myelosuppression	6	11.8 5.3–26.1ROR 12.0 · χ² 49 / p 1e-12	8.3 EB05 3.5 · IC025 +1.3 3/3 methods agree	Not in label — unassessed	serious PRR 7.5	no trial data cached
Eosinophilia	6	23.0 10.4–50.8ROR 23.4 · χ² 105 / p 5e-25	20.1 EB05 7.7 · IC025 +1.7 3/3 methods agree	Not in label — unassessed	serious PRR 15.3	no trial data cached
Lung infection	6	25.5 11.6–56.4ROR 26.0 · χ² 118 / p 9e-28	22.6 EB05 9.2 · IC025 +1.7 3/3 methods agree	Not in label — unassessed	serious PRR 17.4	no trial data cached
Nephropathy toxic	4	24.1 9.1–63.7ROR 24.4 · χ² 67 / p 1e-16	18.0 EB05 4.7 · IC025 +1.0 3/3 methods agree	Not in label — unassessed	serious PRR 11.8	no trial data cached

Unlabeled candidate signals

These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.

Ascites — n=22, PRR 50.1

Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.

Common questions

What are the most reported side effects of Terlipressin?

In FDA FAERS, the most frequently co-reported reaction terms for Terlipressin are ascites, electrocardiogram qt prolonged, multiple organ dysfunction syndrome, hepatic encephalopathy, multi-organ failure, myelosuppression. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.

Does Terlipressin have an FDA boxed warning?

Yes. The current FDA label carries a boxed warning: SERIOUS OR FATAL RESPIRATORY FAILURE TERLIVAZ may cause serious or fatal respiratory failure. Patients with volume overload or with acute-on-chronic liver failure (ACLF) Grade 3 are at increased risk [see References (15) ]. Assess oxygenation saturation (e.g., SpO 2 ) before initiating TERLIVAZ.

Do FAERS signals prove that Terlipressin causes these side effects?

No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.

Sources & methods

FDA label via openFDA (set ID 3a35b86c-f451-4fac-8499-43019e4da354, effective 20260619; matched on openfda.generic_name.exact:"TERLIPRESSIN")
Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA count= aggregation, field patient.drug.openfda.generic_name.exact, 9 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction
Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
Seriousness and sex counts from openFDA count=serious, patient.patientsex, seriousnessdeath

Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.