Drug · FAERS side-effect profile with label screen
Dobutamine side effects: what 3,718 FDA adverse event reports show
Drug class
Not stated in label
Who reports
3,718 reports · 95% serious · 1,409 with death outcome · 44% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Dobutamine Injection, USP is indicated when parenteral therapy is necessary for inotropic support in the short-term treatment of patients with cardiac decompensation due to depressed contractility resulting either from organic heart disease or from cardiac surgical procedures. Experience with intravenous dobutamine in controlled trials does not extend beyond 48 hours of repeated boluses and/or continuous infusions.
FDA label, Indications and Usage
What it is
DESCRIPTION Dobutamine Injection, USP is a clear, practically colorless, sterile, nonpyrogenic solution of dobutamine hydrochloride for intravenous use only. Each milliliter contains 12.5 mg (41.5 µmol) dobutamine, as the hydrochloride and sodium metabisulfite, 0.2 mg added as antioxidant.
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 1Labeled (related wording) 1Likely indication confounding 2Reporting / coding artifact 3Lab value / disease marker 2Not in label — unassessed 31
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.
- Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
- 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. 190 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 | 417 | 169.8 154.9–186.2ROR 191.2 · χ² 67,802 / p <1e-300 | 163.6 EB05 150.9 · IC025 +6.9 3/3 methods agree | Not in label — unassessed | serious PRR 99.5 · 98% clinician | no trial data cached |
| Appendicitis | 241 | 150.2 132.7–170.0ROR 160.5 · χ² 34,641 / p <1e-300 | 144.6 EB05 129.9 · IC025 +6.6 3/3 methods agree | Not in label — unassessed | serious PRR 89.7 · ♀ 0% (drug 44%) · 97% clinician | no trial data cached |
| Ventricular fibrillation | 238 | 123.2 108.8–139.5ROR 131.5 · χ² 28,115 / p <1e-300 | 119.4 EB05 107.2 · IC025 +6.4 3/3 methods agree | Labeled (related wording) related wording | serious PRR 73.0 · ♀ 9% (drug 44%) · 95% clinician | no trial data cached |
| Multiple organ dysfunction syndrome | 369 | 75.6 68.6–83.3ROR 83.8 · χ² 26,759 / p <1e-300 | 74.3 EB05 68.2 · IC025 +5.9 3/3 methods agree | Not in label — unassessed | serious PRR 45.0 · ♀ 15% (drug 44%) · 95% clinician | no trial data cached |
| Ascites | 262 | 50.7 45.1–57.0ROR 54.5 · χ² 12,616 / p <1e-300 | 50.1 EB05 45.2 · IC025 +5.3 3/3 methods agree | Not in label — unassessed | serious PRR 30.8 · ♀ 8% (drug 44%) · 97% clinician | no trial data cached |
| Incorrect route of product administration | 120 | 40.6 34.0–48.4ROR 41.9 · χ² 4,562 / p <1e-300 | 40.0 EB05 34.4 · IC025 +4.8 3/3 methods agree | Reporting / coding artifact | serious PRR 48.6 · ♀ 2% (drug 44%) · 96% clinician | no trial data cached |
| Bacterial infection | 121 | 37.0 31.0–44.1ROR 38.2 · χ² 4,177 / p <1e-300 | 36.6 EB05 31.4 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious PRR 25.7 · ♀ 2% (drug 44%) · 97% clinician | no trial data cached |
| Hyperlipidaemia | 62 | 29.3 22.9–37.6ROR 29.8 · χ² 1,660 / p <1e-300 | 28.9 EB05 23.4 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious PRR 19.4 · ♀ 0% (drug 44%) · 97% clinician | no trial data cached |
| Neuralgia | 119 | 27.8 23.3–33.2ROR 28.7 · χ² 3,037 / p <1e-300 | 27.6 EB05 23.7 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious PRR 24.8 · ♀ 0% (drug 44%) · 97% clinician | no trial data cached |
| Toxic epidermal necrolysis (severe skin peeling reaction) | 72 | 27.1 21.5–34.0ROR 27.6 · χ² 1,774 / p <1e-300 | 26.8 EB05 22.0 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious PRR 16.3 | no trial data cached |
| Hyponatraemia (low sodium) | 256 | 25.8 22.9–29.1ROR 27.6 · χ² 6,068 / p <1e-300 | 25.7 EB05 23.1 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious PRR 15.9 · ♀ 5% (drug 44%) · 96% clinician | no trial data cached |
| Ventricular tachycardia | 73 | 25.0 19.9–31.3ROR 25.4 · χ² 1,649 / p <1e-300 | 24.7 EB05 20.3 · IC025 +4.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 15.2 · 92% clinician | no trial data cached |
| End stage renal disease | 73 | 22.4 17.9–28.2ROR 22.9 · χ² 1,470 / p <1e-300 | 22.2 EB05 18.3 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious PRR 13.5 · ♀ 3% (drug 44%) · 97% clinician | no trial data cached |
| Ulcer | 63 | 22.4 17.5–28.6ROR 22.8 · χ² 1,262 / p 1e-276 | 22.2 EB05 17.9 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious PRR 17.0 · ♀ 0% (drug 44%) · 95% clinician | no trial data cached |
| Aspiration | 41 | 21.4 15.8–29.1ROR 21.7 · χ² 775 / p 6e-171 | 21.2 EB05 16.2 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious PRR 13.3 · ♀ 3% (drug 44%) · 95% clinician | no trial data cached |
| Gout | 66 | 20.8 16.4–26.4ROR 21.2 · χ² 1,221 / p 1e-267 | 20.6 EB05 16.8 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious PRR 18.9 · ♀ 0% (drug 44%) · 98% clinician | no trial data cached |
| Blood test abnormal | 49 | 19.8 14.9–26.1ROR 20.0 · χ² 851 / p 2e-187 | 19.5 EB05 15.4 · IC025 +3.6 3/3 methods agree | Reporting / coding artifact | serious PRR 18.2 · ♀ 4% (drug 44%) · 98% clinician | no trial data cached |
| Stress | 250 | 19.7 17.5–22.2ROR 21.0 · χ² 4,412 / p <1e-300 | 19.6 EB05 17.6 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious PRR 19.7 · ♀ 2% (drug 44%) · 95% clinician | no trial data cached |
| Shock | 71 | 17.6 14.0–22.2ROR 17.9 · χ² 1,093 / p 5e-240 | 17.5 EB05 14.3 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious PRR 10.7 · 94% clinician | no trial data cached |
| Status epilepticus | 35 | 17.5 12.6–24.3ROR 17.7 · χ² 527 / p 7e-117 | 17.2 EB05 12.9 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 10.6 · 94% clinician | no trial data cached |
| Pulmonary hypertension | 64 | 17.3 13.6–22.1ROR 17.6 · χ² 966 / p 3e-212 | 17.2 EB05 13.9 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 10.6 | no trial data cached |
| Sepsis (blood infection) | 338 | 17.1 15.5–19.0ROR 18.7 · χ² 5,131 / p <1e-300 | 17.1 EB05 15.6 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious PRR 10.4 · ♀ 14% (drug 44%) · 95% clinician | no trial data cached |
| Pulmonary arterial hypertension | 42 | 16.3 12.1–22.0ROR 16.5 · χ² 587 / p 5e-130 | 16.1 EB05 12.3 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 10.1 · ♀ 79% (drug 44%) | no trial data cached |
| Disseminated intravascular coagulation | 40 | 16.0 11.8–21.8ROR 16.2 · χ² 547 / p 3e-121 | 15.8 EB05 12.0 · IC025 +3.2 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 9.7 | no trial data cached |
| Micturition urgency | 32 | 16.0 11.3–22.6ROR 16.1 · χ² 433 / p 2e-96 | 15.7 EB05 11.5 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 15.9 · ♀ 0% (drug 44%) · 94% clinician | no trial data cached |
| Multi-organ failure | 49 | 15.8 12.0–20.9ROR 16.0 · χ² 663 / p 2e-146 | 15.6 EB05 12.2 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 9.7 | no trial data cached |
| Cardiomyopathy | 40 | 15.3 11.2–20.8ROR 15.4 · χ² 519 / p 4e-115 | 15.0 EB05 11.4 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious PRR 9.3 · 92% clinician | no trial data cached |
| Hypercholesterolaemia | 25 | 14.8 10.0–21.8ROR 14.9 · χ² 307 / p 6e-69 | 14.3 EB05 9.9 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 9.5 · ♀ 0% (drug 44%) · 96% clinician | no trial data cached |
| Blood cholesterol increased | 121 | 14.7 12.3–17.5ROR 15.1 · χ² 1,527 / p <1e-300 | 14.6 EB05 12.5 · IC025 +3.5 3/3 methods agree | Lab value / disease marker | serious PRR 13.4 · ♀ 1% (drug 44%) · 98% clinician | no trial data cached |
| General physical health deterioration | 296 | 14.6 13.1–16.3ROR 15.7 · χ² 3,738 / p <1e-300 | 14.5 EB05 13.2 · IC025 +3.6 3/3 methods agree | Reporting / coding artifact | serious PRR 10.3 · ♀ 14% (drug 44%) · 95% clinician | no trial data cached |
| Full blood count abnormal | 27 | 14.5 9.9–21.1ROR 14.6 · χ² 325 / p 7e-73 | 14.1 EB05 9.9 · IC025 +2.9 3/3 methods agree | Lab value / disease marker | serious PRR 11.6 · ♀ 0% (drug 44%) · 96% clinician | no trial data cached |
| Septic shock | 109 | 14.3 11.8–17.2ROR 14.7 · χ² 1,330 / p 2e-291 | 14.2 EB05 12.0 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 8.6 · 92% clinician | no trial data cached |
| Obstructive airways disorder | 28 | 14.2 9.8–20.5ROR 14.3 · χ² 329 / p 7e-74 | 13.8 EB05 9.7 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 8.9 · ♀ 0% (drug 44%) | no trial data cached |
| Abdominal distension (bloating) | 260 | 14.1 12.6–15.9ROR 15.1 · χ² 3,169 / p <1e-300 | 14.1 EB05 12.7 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious PRR 14.9 · ♀ 5% (drug 44%) · 96% clinician | no trial data cached |
| Myoclonus | 29 | 13.8 9.6–19.8ROR 13.9 · χ² 330 / p 6e-74 | 13.3 EB05 9.5 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 8.8 · 100% clinician | no trial data cached |
| Acute respiratory distress syndrome | 41 | 13.1 9.7–17.8ROR 13.2 · χ² 446 / p 3e-99 | 12.8 EB05 9.7 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 7.9 · 92% clinician | no trial data cached |
| Chronic obstructive pulmonary disease | 118 | 12.8 10.7–15.3ROR 13.2 · χ² 1,271 / p 9e-279 | 12.7 EB05 10.8 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 9.0 · ♀ 2% (drug 44%) · 97% clinician | no trial data cached |
| Pulmonary congestion | 28 | 12.0 8.3–17.3ROR 12.0 · χ² 270 / p 6e-61 | 11.4 EB05 7.9 · IC025 +2.7 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 8.4 | no trial data cached |
| Hypoxia (low oxygen) | 74 | 11.9 9.5–14.9ROR 12.1 · χ² 730 / p 6e-161 | 11.7 EB05 9.6 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 7.2 | no trial data cached |
| Supraventricular tachycardia | 20 | 11.8 7.6–18.3ROR 11.9 · χ² 187 / p 7e-43 | 10.9 EB05 7.0 · IC025 +2.5 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 |
|---|---|---|---|---|---|---|
| Drug ineffective (drug did not work) | 778 | 3.3 3.1–3.6ROR 4.0 · χ² 1,354 / p 1e-296 | 3.3 EB05 3.1 · IC025 +1.6 3/3 methods agree | Reporting / coding artifact | serious PRR 5.7 · 97% clinician | no trial data cached |
| Off label use (used outside approved label) | 539 | 3.5 3.2–3.8ROR 3.9 · χ² 1,004 / p 1e-220 | 3.5 EB05 3.3 · IC025 +1.7 3/3 methods agree | Reporting / coding artifact | serious PRR 3.8 · 95% clinician | no trial data cached |
| Cardiogenic shock | 417 | 169.8 154.9–186.2ROR 191.2 · χ² 67,802 / p <1e-300 | 163.6 EB05 150.9 · IC025 +6.9 3/3 methods agree | Not in label — unassessed | serious PRR 99.5 · 98% clinician | no trial data cached |
| Multiple organ dysfunction syndrome | 369 | 75.6 68.6–83.3ROR 83.8 · χ² 26,759 / p <1e-300 | 74.3 EB05 68.2 · IC025 +5.9 3/3 methods agree | Not in label — unassessed | serious PRR 45.0 · ♀ 15% (drug 44%) · 95% clinician | no trial data cached |
| Condition aggravated | 338 | 6.3 5.7–7.0ROR 6.9 · χ² 1,529 / p <1e-300 | 6.3 EB05 5.7 · IC025 +2.5 3/3 methods agree | Reporting / coding artifact | serious PRR 5.8 · 95% clinician | no trial data cached |
| Sepsis (blood infection) | 338 | 17.1 15.5–19.0ROR 18.7 · χ² 5,131 / p <1e-300 | 17.1 EB05 15.6 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious PRR 10.4 · ♀ 14% (drug 44%) · 95% clinician | no trial data cached |
| General physical health deterioration | 296 | 14.6 13.1–16.3ROR 15.7 · χ² 3,738 / p <1e-300 | 14.5 EB05 13.2 · IC025 +3.6 3/3 methods agree | Reporting / coding artifact | serious PRR 10.3 · ♀ 14% (drug 44%) · 95% clinician | no trial data cached |
| Vomiting | 276 | 3.3 3.0–3.7ROR 3.5 · χ² 456 / p 2e-101 | 3.3 EB05 3.0 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 3.0 · ♀ 11% (drug 44%) · 96% clinician | no trial data cached |
| Ascites | 262 | 50.7 45.1–57.0ROR 54.5 · χ² 12,616 / p <1e-300 | 50.1 EB05 45.2 · IC025 +5.3 3/3 methods agree | Not in label — unassessed | serious PRR 30.8 · ♀ 8% (drug 44%) · 97% clinician | no trial data cached |
| Abdominal distension (bloating) | 260 | 14.1 12.6–15.9ROR 15.1 · χ² 3,169 / p <1e-300 | 14.1 EB05 12.7 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious PRR 14.9 · ♀ 5% (drug 44%) · 96% clinician | no trial data cached |
| Hyponatraemia (low sodium) | 256 | 25.8 22.9–29.1ROR 27.6 · χ² 6,068 / p <1e-300 | 25.7 EB05 23.1 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious PRR 15.9 · ♀ 5% (drug 44%) · 96% clinician | no trial data cached |
| Stress | 250 | 19.7 17.5–22.2ROR 21.0 · χ² 4,412 / p <1e-300 | 19.6 EB05 17.6 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious PRR 19.7 · ♀ 2% (drug 44%) · 95% clinician | no trial data cached |
| Abdominal pain | 246 | 6.0 5.3–6.7ROR 6.3 · χ² 1,024 / p 5e-225 | 5.9 EB05 5.3 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 4.8 · ♀ 5% (drug 44%) · 97% clinician | no trial data cached |
| Death | 243 | 1.6 1.4–1.8ROR 1.6 · χ² 55 / p 6e-14 | 1.6 EB05 1.4 · IC025 +0.5 | Outcome field, not a reaction | serious PRR 1.0 · 93% clinician | no trial data cached |
| Constipation | 243 | 6.3 5.6–7.2ROR 6.7 · χ² 1,098 / p 5e-241 | 6.3 EB05 5.6 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 6.9 · ♀ 6% (drug 44%) · 95% 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=417, PRR 169.8
- Appendicitis — n=241, PRR 150.2
- Multiple organ dysfunction syndrome — n=369, PRR 75.6
- Ascites — n=262, PRR 50.7
- Bacterial infection — n=121, PRR 37.0
- Hyperlipidaemia — n=62, PRR 29.3
- Neuralgia — n=119, PRR 27.8
- Toxic epidermal necrolysis — n=72, PRR 27.1
- Hyponatraemia — n=256, PRR 25.8
- End stage renal disease — n=73, PRR 22.4
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 Dobutamine?
In FDA FAERS, the most frequently co-reported reaction terms for Dobutamine are cardiogenic shock, multiple organ dysfunction syndrome, sepsis, vomiting, ascites, abdominal distension. 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 Dobutamine have an FDA boxed warning?
No. The FDA label retrieved for Dobutamine has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Dobutamine 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 ee09a55f-9992-48bb-b8d6-1184bd548536, effective 20260126; matched on
openfda.generic_name.exact:"DOBUTAMINE") - 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, 230 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.