Drug · FAERS side-effect profile with label screen
Vasopressin side effects: what 4,355 FDA adverse event reports show
Drug class
Not stated in label
Who reports
4,355 reports · 96% serious · 1,717 with death outcome · 42% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Vasopressin injection is indicated to increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines. Vasopressin injection is indicated to increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines. ( 1 )
FDA label, Indications and Usage
What it is
Vasopressin is a polypeptide hormone. Vasopressin injection, USP is a sterile, aqueous solution of synthetic arginine vasopressin for intravenous administration. The 1 mL solution contains vasopressin, USP 20 units/mL, 1.36 mg sodium acetate trihydrate and Water for Injection, USP.
FDA label, Description section
Boxed warning
None in the current 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 40 strongest signals
Labeled adverse reaction 1Likely indication confounding 1Reporting / coding artifact 3Lab value / disease marker 1Not in label — unassessed 34
What the badges mean
- Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
- Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
- Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
- Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
- 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. 186 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
Show:
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Cardiogenic shock | 418 | 145.3 132.5–159.4ROR 160.6 · χ² 58,029 / p <1e-300 | 140.1 EB05 129.2 · IC025 +6.8 3/3 methods agree | Not in label — unassessed | serious PRR 84.2 · 95% clinician | no trial data cached |
| Appendicitis | 259 | 138.0 122.4–155.6ROR 146.7 · χ² 34,116 / p <1e-300 | 132.8 EB05 119.8 · IC025 +6.5 3/3 methods agree | Not in label — unassessed | serious PRR 81.3 · ♀ 7% (drug 42%) · 96% clinician | no trial data cached |
| Ventricular fibrillation | 231 | 102.0 89.8–115.8ROR 107.6 · χ² 22,524 / p <1e-300 | 99.1 EB05 88.8 · IC025 +6.1 3/3 methods agree | Not in label — unassessed | serious PRR 59.8 · ♀ 10% (drug 42%) · 96% clinician | no trial data cached |
| Multiple organ dysfunction syndrome | 409 | 71.6 65.3–78.6ROR 78.9 · χ² 28,024 / p <1e-300 | 70.3 EB05 64.8 · IC025 +5.9 3/3 methods agree | Not in label — unassessed | serious PRR 42.0 · ♀ 21% (drug 42%) · 96% clinician | no trial data cached |
| Ascites | 282 | 46.6 41.6–52.2ROR 49.8 · χ² 12,433 / p <1e-300 | 46.0 EB05 41.7 · IC025 +5.2 3/3 methods agree | Not in label — unassessed | serious PRR 28.0 · ♀ 11% (drug 42%) · 94% clinician | no trial data cached |
| Shock | 198 | 42.1 36.8–48.3ROR 44.1 · χ² 7,850 / p <1e-300 | 41.6 EB05 37.0 · IC025 +5.0 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 25.1 · 95% clinician | no trial data cached |
| Bacterial infection | 140 | 36.6 31.0–43.1ROR 37.7 · χ² 4,775 / p <1e-300 | 36.1 EB05 31.4 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious PRR 25.1 · ♀ 17% (drug 42%) · 96% clinician | no trial data cached |
| Incorrect route of product administration | 122 | 35.2 29.5–42.0ROR 36.2 · χ² 3,994 / p <1e-300 | 34.8 EB05 29.9 · IC025 +4.6 3/3 methods agree | Reporting / coding artifact | serious PRR 41.4 · ♀ 7% (drug 42%) · 98% clinician | no trial data cached |
| Acute respiratory distress syndrome | 125 | 34.3 28.8–40.7ROR 35.2 · χ² 3,977 / p <1e-300 | 33.9 EB05 29.2 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious PRR 20.4 · 93% clinician | no trial data cached |
| Hyperlipidaemia | 76 | 30.7 24.6–38.4ROR 31.2 · χ² 2,143 / p <1e-300 | 30.3 EB05 25.0 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious PRR 20.1 · 97% clinician | no trial data cached |
| Metabolic acidosis | 185 | 28.3 24.6–32.6ROR 29.5 · χ² 4,823 / p <1e-300 | 28.1 EB05 24.8 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious PRR 16.9 · 97% clinician | no trial data cached |
| Lactic acidosis | 178 | 26.9 23.2–31.0ROR 28.0 · χ² 4,386 / p <1e-300 | 26.6 EB05 23.5 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious PRR 16.0 · 95% clinician | no trial data cached |
| Multi-organ failure | 96 | 26.5 21.7–32.3ROR 27.1 · χ² 2,318 / p <1e-300 | 26.2 EB05 22.1 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious PRR 15.8 | no trial data cached |
| Hyponatraemia (low sodium) | 281 | 24.2 21.6–27.1ROR 25.8 · χ² 6,208 / p <1e-300 | 24.0 EB05 21.8 · IC025 +4.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 14.7 · ♀ 11% (drug 42%) · 96% clinician | no trial data cached |
| Neuralgia | 118 | 23.5 19.7–28.1ROR 24.2 · χ² 2,514 / p <1e-300 | 23.3 EB05 20.0 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious PRR 20.8 · ♀ 6% (drug 42%) · 97% clinician | no trial data cached |
| End stage renal disease | 82 | 21.5 17.4–26.7ROR 21.9 · χ² 1,579 / p <1e-300 | 21.3 EB05 17.7 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious PRR 12.8 · 96% clinician | no trial data cached |
| Disseminated intravascular coagulation | 62 | 21.2 16.6–27.2ROR 21.5 · χ² 1,171 / p 8e-257 | 21.0 EB05 17.0 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious PRR 12.7 · ♀ 63% (drug 42%) · 92% clinician | no trial data cached |
| Stress | 310 | 20.8 18.7–23.2ROR 22.4 · χ² 5,830 / p <1e-300 | 20.7 EB05 18.9 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious PRR 20.5 · ♀ 11% (drug 42%) | no trial data cached |
| Septic shock | 182 | 20.4 17.7–23.5ROR 21.2 · χ² 3,323 / p <1e-300 | 20.2 EB05 17.9 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious PRR 12.0 · 91% clinician | no trial data cached |
| Blood test abnormal | 59 | 20.3 15.8–26.2ROR 20.6 · χ² 1,060 / p 7e-233 | 20.1 EB05 16.2 · IC025 +3.7 3/3 methods agree | Reporting / coding artifact | serious PRR 18.5 · 97% clinician | no trial data cached |
| Gout | 75 | 20.2 16.1–25.3ROR 20.5 · χ² 1,344 / p 2e-294 | 20.0 EB05 16.5 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious PRR 18.1 · 99% clinician | no trial data cached |
| Ulcer | 64 | 19.4 15.2–24.8ROR 19.7 · χ² 1,096 / p 1e-240 | 19.2 EB05 15.6 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious PRR 14.6 · ♀ 12% (drug 42%) · 95% clinician | no trial data cached |
| Respiratory depression | 45 | 17.7 13.3–23.7ROR 17.9 · χ² 692 / p 1e-152 | 17.5 EB05 13.6 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 10.9 · 93% clinician | no trial data cached |
| Intentional overdose | 232 | 17.6 15.5–19.9ROR 18.5 · χ² 3,610 / p <1e-300 | 17.5 EB05 15.7 · IC025 +3.9 3/3 methods agree | Reporting / coding artifact | serious PRR 10.9 · ♀ 75% (drug 42%) · 96% clinician | no trial data cached |
| Sepsis (blood infection) | 404 | 17.5 15.9–19.2ROR 19.2 · χ² 6,275 / p <1e-300 | 17.4 EB05 16.0 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious PRR 10.5 · ♀ 16% (drug 42%) · 95% clinician | no trial data cached |
| Renal tubular necrosis | 35 | 17.2 12.4–23.9ROR 17.3 · χ² 516 / p 1e-114 | 16.9 EB05 12.6 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious PRR 10.3 | no trial data cached |
| Hypoxia (low oxygen) | 120 | 16.5 13.9–19.7ROR 17.0 · χ² 1,732 / p <1e-300 | 16.4 EB05 14.1 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious PRR 10.0 · ♀ 67% (drug 42%) · 92% clinician | no trial data cached |
| Fear | 91 | 16.2 13.2–19.9ROR 16.5 · χ² 1,282 / p 6e-281 | 16.1 EB05 13.5 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious PRR 13.1 | no trial data cached |
| Ventricular tachycardia | 55 | 16.0 12.3–20.9ROR 16.2 · χ² 758 / p 3e-167 | 15.9 EB05 12.6 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 9.5 · 94% clinician | no trial data cached |
| Hypothermia | 33 | 15.7 11.2–22.1ROR 15.8 · χ² 439 / p 1e-97 | 15.4 EB05 11.3 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 9.5 · ♀ 94% (drug 42%) | no trial data cached |
| Cardiac arrest (heart stopping) | 267 | 15.6 13.9–17.5ROR 16.5 · χ² 3,626 / p <1e-300 | 15.5 EB05 14.0 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious PRR 9.3 · 95% clinician | no trial data cached |
| Circulatory collapse | 54 | 15.2 11.7–19.9ROR 15.4 · χ² 703 / p 3e-155 | 15.1 EB05 11.9 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 9.1 · ♀ 71% (drug 42%) · 92% clinician | no trial data cached |
| Serotonin syndrome | 60 | 15.1 11.8–19.5ROR 15.3 · χ² 777 / p 3e-171 | 15.0 EB05 12.0 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 8.9 · 97% clinician | no trial data cached |
| Blood cholesterol increased | 143 | 14.8 12.6–17.4ROR 15.3 · χ² 1,825 / p <1e-300 | 14.7 EB05 12.8 · IC025 +3.5 3/3 methods agree | Lab value / disease marker | serious PRR 13.4 · ♀ 13% (drug 42%) · 97% clinician | no trial data cached |
| Renal injury | 91 | 14.6 11.9–17.9ROR 14.9 · χ² 1,141 / p 2e-250 | 14.5 EB05 12.1 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 8.7 | no trial data cached |
| Coagulopathy | 50 | 14.5 11.0–19.1ROR 14.7 · χ² 615 / p 4e-136 | 14.3 EB05 11.2 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious PRR 9.0 · 96% clinician | no trial data cached |
| Acute respiratory failure | 57 | 14.4 11.1–18.6ROR 14.6 · χ² 694 / p 2e-153 | 14.2 EB05 11.3 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious PRR 8.6 | no trial data cached |
| Aspiration | 32 | 14.3 10.1–20.2ROR 14.4 · χ² 380 / p 5e-85 | 13.9 EB05 10.1 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 8.7 · ♀ 11% (drug 42%) · 97% clinician | no trial data cached |
| Status epilepticus | 33 | 14.1 10.0–19.8ROR 14.2 · χ² 387 / p 2e-86 | 13.7 EB05 10.0 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 8.4 | no trial data cached |
| Anhedonia | 71 | 12.9 10.3–16.3ROR 13.1 · χ² 769 / p 1e-169 | 12.8 EB05 10.4 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious PRR 8.5 | 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 |
|---|---|---|---|---|---|---|
| Drug ineffective (drug did not work) | 1,333 | 4.9 4.7–5.1ROR 6.6 · χ² 4,377 / p <1e-300 | 4.9 EB05 4.7 · IC025 +2.2 3/3 methods agree | Reporting / coding artifact | serious PRR 8.2 · 99% clinician | no trial data cached |
| Off label use (used outside approved label) | 545 | 3.0 2.8–3.3ROR 3.3 · χ² 768 / p 2e-169 | 3.0 EB05 2.8 · IC025 +1.5 3/3 methods agree | Reporting / coding artifact | serious PRR 3.2 · 96% clinician | no trial data cached |
| Hypotension (low blood pressure) | 508 | 12.2 11.3–13.3ROR 13.7 · χ² 5,270 / p <1e-300 | 12.2 EB05 11.3 · IC025 +3.4 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 8.4 · 93% clinician | no trial data cached |
| Cardiogenic shock | 418 | 145.3 132.5–159.4ROR 160.6 · χ² 58,029 / p <1e-300 | 140.1 EB05 129.2 · IC025 +6.8 3/3 methods agree | Not in label — unassessed | serious PRR 84.2 · 95% clinician | no trial data cached |
| Multiple organ dysfunction syndrome | 409 | 71.6 65.3–78.6ROR 78.9 · χ² 28,024 / p <1e-300 | 70.3 EB05 64.8 · IC025 +5.9 3/3 methods agree | Not in label — unassessed | serious PRR 42.0 · ♀ 21% (drug 42%) · 96% clinician | no trial data cached |
| Sepsis (blood infection) | 404 | 17.5 15.9–19.2ROR 19.2 · χ² 6,275 / p <1e-300 | 17.4 EB05 16.0 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious PRR 10.5 · ♀ 16% (drug 42%) · 95% clinician | no trial data cached |
| Condition aggravated | 392 | 6.3 5.7–6.9ROR 6.8 · χ² 1,749 / p <1e-300 | 6.2 EB05 5.7 · IC025 +2.5 3/3 methods agree | Reporting / coding artifact | serious PRR 5.7 · 95% clinician | no trial data cached |
| Toxicity to various agents | 338 | 9.7 8.8–10.8ROR 10.4 · χ² 2,649 / p <1e-300 | 9.6 EB05 8.8 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 6.0 · ♀ 63% (drug 42%) · 98% clinician | no trial data cached |
| Acute kidney injury (sudden kidney damage) | 333 | 10.5 9.5–11.7ROR 11.3 · χ² 2,883 / p <1e-300 | 10.5 EB05 9.6 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious PRR 6.2 · 96% clinician | no trial data cached |
| Vomiting | 310 | 3.2 2.9–3.5ROR 3.4 · χ² 473 / p 4e-105 | 3.2 EB05 2.9 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 2.8 · ♀ 15% (drug 42%) · 95% clinician | no trial data cached |
| Stress | 310 | 20.8 18.7–23.2ROR 22.4 · χ² 5,830 / p <1e-300 | 20.7 EB05 18.9 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious PRR 20.5 · ♀ 11% (drug 42%) | no trial data cached |
| Abdominal pain | 289 | 6.0 5.4–6.7ROR 6.3 · χ² 1,209 / p 4e-265 | 5.9 EB05 5.4 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 4.7 · ♀ 11% (drug 42%) · 96% clinician | no trial data cached |
| General physical health deterioration | 286 | 12.0 10.7–13.4ROR 12.8 · χ² 2,885 / p <1e-300 | 11.9 EB05 10.8 · IC025 +3.4 3/3 methods agree | Reporting / coding artifact | serious PRR 8.4 · ♀ 10% (drug 42%) · 95% clinician | no trial data cached |
| Ascites | 282 | 46.6 41.6–52.2ROR 49.8 · χ² 12,433 / p <1e-300 | 46.0 EB05 41.7 · IC025 +5.2 3/3 methods agree | Not in label — unassessed | serious PRR 28.0 · ♀ 11% (drug 42%) · 94% clinician | no trial data cached |
| Hyponatraemia (low sodium) | 281 | 24.2 21.6–27.1ROR 25.8 · χ² 6,208 / p <1e-300 | 24.0 EB05 21.8 · IC025 +4.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 14.7 · ♀ 11% (drug 42%) · 96% clinician | 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.
- Cardiogenic shock — n=418, PRR 145.3
- Appendicitis — n=259, PRR 138.0
- Ventricular fibrillation — n=231, PRR 102.0
- Multiple organ dysfunction syndrome — n=409, PRR 71.6
- Ascites — n=282, PRR 46.6
- Bacterial infection — n=140, PRR 36.6
- Acute respiratory distress syndrome — n=125, PRR 34.3
- Hyperlipidaemia — n=76, PRR 30.7
- Metabolic acidosis — n=185, PRR 28.3
- Lactic acidosis — n=178, PRR 26.9
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 Vasopressin?
In FDA FAERS, the most frequently co-reported reaction terms for Vasopressin are hypotension, cardiogenic shock, multiple organ dysfunction syndrome, sepsis, toxicity to various agents, acute kidney injury. 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 Vasopressin have an FDA boxed warning?
No. The FDA label retrieved for Vasopressin has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Vasopressin 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 3532868c-ac1d-43c8-e063-6394a90a4fd1, effective 20250515; matched on
openfda.generic_name.exact:"VASOPRESSIN") - 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, fieldpatient.drug.openfda.generic_name.exact, 226 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.