Drug · FAERS side-effect profile with label screen

Isoproterenol side effects: what 422 FDA adverse event reports show

Isoproterenol Hydrochloride · 13 reaction terms · 150 drug–reaction co-reports · data 2026-09-14

Drug class

Beta-adrenergic agonist

FDA label, Indications wording of the closest related product

Label matched

Isoproterenol Hydrochloride (Isoproterenol Hydrochloride)

closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match

Who reports

422 reports · 95% serious · 56 with death outcome · 49% female

openFDA FAERS counts, all years, deduplication not applied

Used for

Isoproterenol hydrochloride injection is indicated: • To improve hemodynamic status in patients in distributive shock and shock due to reduced cardiac output • For bronchospasm occurring during anesthesia INDICATIONS AND USAGE Isoproterenol hydrochlori.

FDA label, Indications and Usage

What it is

Isoproterenol hydrochloride is 3,4-Dihydroxy-α-[(isopropylamino)methyl] benzyl alcohol hydrochloride, a beta-adrenergic agonist and a synthetic sympathomimetic amine that is structurally related to epinephrine.

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 8 strongest signals

Labeled (related wording) 1Not in label — unassessed 7

What the badges mean

Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
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. 5 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
Ventricular fibrillation	20	89.4 58.2–137.1ROR 93.8 · χ² 1,658 / p <1e-300	82.4 EB05 56.3 · IC025 +4.1 3/3 methods agree	Not in label — unassessed	serious PRR 54.1 · 100% clinician	no trial data cached
Ventricular tachycardia	27	81.1 56.3–116.8ROR 86.6 · χ² 2,054 / p <1e-300	76.7 EB05 55.4 · IC025 +4.4 3/3 methods agree	Labeled (related wording) related wording	serious PRR 49.5 · 100% clinician	no trial data cached
Cardiogenic shock	21	73.2 48.2–111.1ROR 77.0 · χ² 1,424 / p <1e-300	68.7 EB05 47.4 · IC025 +4.0 3/3 methods agree	Not in label — unassessed	serious PRR 44.2	no trial data cached
Toxic epidermal necrolysis (severe skin peeling reaction)	20	66.0 43.0–101.2ROR 69.2 · χ² 1,215 / p 2e-266	62.2 EB05 42.5 · IC025 +3.9 3/3 methods agree	Not in label — unassessed	serious PRR 40.0 · 90% clinician	no trial data cached
Ventricular extrasystoles	9	43.0 22.5–82.1ROR 43.9 · χ² 329 / p 1e-73	39.7 EB05 22.3 · IC025 +2.6 3/3 methods agree	Not in label — unassessed	serious PRR 29.0	no trial data cached
Sinus bradycardia	8	41.1 20.7–81.6ROR 41.8 · χ² 274 / p 8e-62	37.6 EB05 20.3 · IC025 +2.4 3/3 methods agree	Not in label — unassessed	serious PRR 25.6	no trial data cached
Electrocardiogram qt prolonged	23	31.8 21.4–47.3ROR 33.5 · χ² 656 / p 6e-145	31.0 EB05 21.8 · IC025 +3.6 3/3 methods agree	Not in label — unassessed	serious PRR 19.6 · 100% clinician	no trial data cached
Premature delivery	6	18.6 8.4–41.3ROR 18.9 · χ² 83 / p 3e-20	15.4 EB05 5.6 · IC025 +1.6 3/3 methods agree	Not in label — unassessed	serious PRR 11.6	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
Ventricular tachycardia	27	81.1 56.3–116.8ROR 86.6 · χ² 2,054 / p <1e-300	76.7 EB05 55.4 · IC025 +4.4 3/3 methods agree	Labeled (related wording) related wording	serious PRR 49.5 · 100% clinician	no trial data cached
Electrocardiogram qt prolonged	23	31.8 21.4–47.3ROR 33.5 · χ² 656 / p 6e-145	31.0 EB05 21.8 · IC025 +3.6 3/3 methods agree	Not in label — unassessed	serious PRR 19.6 · 100% clinician	no trial data cached
Cardiogenic shock	21	73.2 48.2–111.1ROR 77.0 · χ² 1,424 / p <1e-300	68.7 EB05 47.4 · IC025 +4.0 3/3 methods agree	Not in label — unassessed	serious PRR 44.2	no trial data cached
Toxic epidermal necrolysis (severe skin peeling reaction)	20	66.0 43.0–101.2ROR 69.2 · χ² 1,215 / p 2e-266	62.2 EB05 42.5 · IC025 +3.9 3/3 methods agree	Not in label — unassessed	serious PRR 40.0 · 90% clinician	no trial data cached
Ventricular fibrillation	20	89.4 58.2–137.1ROR 93.8 · χ² 1,658 / p <1e-300	82.4 EB05 56.3 · IC025 +4.1 3/3 methods agree	Not in label — unassessed	serious PRR 54.1 · 100% clinician	no trial data cached
Ventricular extrasystoles	9	43.0 22.5–82.1ROR 43.9 · χ² 329 / p 1e-73	39.7 EB05 22.3 · IC025 +2.6 3/3 methods agree	Not in label — unassessed	serious PRR 29.0	no trial data cached
Sinus bradycardia	8	41.1 20.7–81.6ROR 41.8 · χ² 274 / p 8e-62	37.6 EB05 20.3 · IC025 +2.4 3/3 methods agree	Not in label — unassessed	serious PRR 25.6	no trial data cached
Premature delivery	6	18.6 8.4–41.3ROR 18.9 · χ² 83 / p 3e-20	15.4 EB05 5.6 · IC025 +1.6 3/3 methods agree	Not in label — unassessed	serious PRR 11.6	no trial data cached
Myocarditis	4	17.6 6.6–46.6ROR 17.7 · χ² 47 / p 4e-12	11.6 EB05 3.4 · IC025 +0.9 3/3 methods agree	Not in label — unassessed	serious PRR 10.7	no trial data cached
Respiratory depression	3	12.2 3.9–37.6ROR 12.2 · χ² 21 / p 3e-6	6.1 EB05 2.0 · IC025 +0.2	Not in label — unassessed	serious PRR 7.6	no trial data cached
Neuroleptic malignant syndrome	3	12.5 4.1–38.7ROR 12.6 · χ² 21 / p 2e-6	6.3 EB05 2.0 · IC025 +0.2 3/3 methods agree	Not in label — unassessed	serious PRR 7.6	no trial data cached
Caesarean section	3	12.7 4.1–39.2ROR 12.8 · χ² 22 / p 2e-6	6.4 EB05 2.0 · IC025 +0.2 3/3 methods agree	Not in label — unassessed	serious PRR 7.9	no trial data cached
Rebound effect	3	13.1 4.3–40.6ROR 13.2 · χ² 23 / p 1e-6	6.7 EB05 2.1 · IC025 +0.2 3/3 methods agree	Not in label — unassessed	serious PRR 12.8	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.

Ventricular fibrillation — n=20, PRR 89.4
Cardiogenic shock — n=21, PRR 73.2
Toxic epidermal necrolysis — n=20, PRR 66.0
Electrocardiogram qt prolonged — n=23, PRR 31.8

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 Isoproterenol?

In FDA FAERS, the most frequently co-reported reaction terms for Isoproterenol are ventricular tachycardia, electrocardiogram qt prolonged, cardiogenic shock, toxic epidermal necrolysis, ventricular fibrillation, ventricular extrasystoles. 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 Isoproterenol have an FDA boxed warning?

No. The FDA label retrieved for Isoproterenol has no boxed warning; see the label's Warnings and Precautions for the recognised risks.

Do FAERS signals prove that Isoproterenol 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 051acbc2-7bf8-4059-e063-6394a90a115b, effective 20260317; matched on openfda.generic_name.exact:"ISOPROTERENOL HYDROCHLORIDE")
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, 13 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.