Dobutamine Hydrochloride side effects: what 1,269 FDA adverse event reports show

Dobutamine Hydrochloride · 80 reaction terms · 4,348 drug–reaction co-reports · data 2026-09-14

Drug class

Not stated in label

Who reports

1,269 reports · 97% serious · 528 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 (related wording) 1Likely indication confounding 1Reporting / coding artifact 4Lab value / disease marker 2Not in label — unassessed 32

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.
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. 40 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
Appendicitis	104	187.1 155.5–225.2ROR 203.7 · χ² 18,859 / p <1e-300	179.0 EB05 151.9 · IC025 +6.3 3/3 methods agree	Not in label — unassessed	serious PRR 111.6 · ♀ 5% (drug 44%) · 93% clinician	no trial data cached
Ventricular fibrillation	113	169.5 142.0–202.3ROR 186.0 · χ² 18,577 / p <1e-300	163.2 EB05 139.4 · IC025 +6.3 3/3 methods agree	Labeled (related wording) related wording	serious PRR 100.0 · ♀ 12% (drug 44%) · 93% clinician	no trial data cached
Cardiogenic shock	123	143.8 121.5–170.2ROR 159.1 · χ² 17,158 / p <1e-300	139.5 EB05 120.0 · IC025 +6.2 3/3 methods agree	Not in label — unassessed	serious PRR 84.7 · ♀ 14% (drug 44%) · 92% clinician	no trial data cached
Multiple organ dysfunction syndrome	135	80.4 68.5–94.3ROR 89.8 · χ² 10,467 / p <1e-300	79.1 EB05 68.5 · IC025 +5.7 3/3 methods agree	Not in label — unassessed	serious PRR 47.5 · ♀ 11% (drug 44%) · 94% clinician	no trial data cached
Bacterial infection	77	68.8 55.4–85.5ROR 73.2 · χ² 5,063 / p <1e-300	67.5 EB05 55.7 · IC025 +5.2 3/3 methods agree	Not in label — unassessed	serious PRR 47.1 · ♀ 7% (drug 44%) · 95% clinician	no trial data cached
Incorrect route of product administration	67	66.2 52.4–83.6ROR 69.8 · χ² 4,223 / p <1e-300	64.8 EB05 52.8 · IC025 +5.1 3/3 methods agree	Reporting / coding artifact	serious PRR 78.4 · ♀ 8% (drug 44%) · 97% clinician	no trial data cached
Hyperlipidaemia	47	65.1 49.1–86.2ROR 67.6 · χ² 2,893 / p <1e-300	63.3 EB05 49.5 · IC025 +4.8 3/3 methods agree	Not in label — unassessed	serious PRR 42.5 · ♀ 15% (drug 44%) · 96% clinician	no trial data cached
Ascites	113	63.8 53.5–76.1ROR 69.9 · χ² 6,902 / p <1e-300	62.9 EB05 53.7 · IC025 +5.3 3/3 methods agree	Not in label — unassessed	serious PRR 38.3 · ♀ 9% (drug 44%) · 94% clinician	no trial data cached
Neuralgia	78	53.4 43.0–66.2ROR 56.8 · χ² 3,946 / p <1e-300	52.5 EB05 43.5 · IC025 +4.9 3/3 methods agree	Not in label — unassessed	serious PRR 47.0 · ♀ 7% (drug 44%) · 95% clinician	no trial data cached
Ulcer	51	53.1 40.6–69.5ROR 55.3 · χ² 2,549 / p <1e-300	52.0 EB05 41.1 · IC025 +4.7 3/3 methods agree	Not in label — unassessed	serious PRR 39.7 · ♀ 11% (drug 44%) · 92% clinician	no trial data cached
Aspiration	31	47.4 33.5–67.2ROR 48.6 · χ² 1,360 / p 4e-298	46.1 EB05 34.0 · IC025 +4.2 3/3 methods agree	Not in label — unassessed	serious PRR 28.9 · ♀ 7% (drug 44%) · 100% clinician	no trial data cached
Gout	50	46.1 35.2–60.6ROR 48.0 · χ² 2,159 / p <1e-300	45.3 EB05 35.7 · IC025 +4.5 3/3 methods agree	Not in label — unassessed	serious PRR 41.4 · ♀ 11% (drug 44%) · 96% clinician	no trial data cached
End stage renal disease	49	44.1 33.5–58.1ROR 45.8 · χ² 2,018 / p <1e-300	43.3 EB05 34.0 · IC025 +4.5 3/3 methods agree	Not in label — unassessed	serious PRR 26.1 · ♀ 12% (drug 44%) · 92% clinician	no trial data cached
Fear	72	44.0 35.2–55.1ROR 46.6 · χ² 2,982 / p <1e-300	43.5 EB05 35.7 · IC025 +4.7 3/3 methods agree	Not in label — unassessed	serious PRR 35.0	no trial data cached
Blood test abnormal	37	43.7 31.8–60.0ROR 45.0 · χ² 1,498 / p <1e-300	42.7 EB05 32.3 · IC025 +4.2 3/3 methods agree	Reporting / coding artifact	serious PRR 39.7 · ♀ 16% (drug 44%) · 95% clinician	no trial data cached
Multi-organ failure	43	40.6 30.3–54.5ROR 42.0 · χ² 1,620 / p <1e-300	39.9 EB05 30.8 · IC025 +4.3 3/3 methods agree	Not in label — unassessed	serious PRR 24.1	no trial data cached
Hypercholesterolaemia	23	39.8 26.6–59.8ROR 40.6 · χ² 831 / p 5e-183	38.6 EB05 27.1 · IC025 +3.7 3/3 methods agree	Not in label — unassessed	serious PRR 25.1 · ♀ 10% (drug 44%) · 100% clinician	no trial data cached
Full blood count abnormal	25	39.3 26.6–58.0ROR 40.1 · χ² 893 / p 1e-196	38.2 EB05 27.2 · IC025 +3.8 3/3 methods agree	Lab value / disease marker	serious PRR 31.0 · ♀ 5% (drug 44%) · 100% clinician	no trial data cached
Stress	167	38.5 33.4–44.3ROR 44.2 · χ² 6,066 / p <1e-300	38.2 EB05 33.6 · IC025 +4.9 3/3 methods agree	Not in label — unassessed	serious PRR 37.7 · ♀ 16% (drug 44%)	no trial data cached
Micturition urgency	26	38.0 26.0–55.6ROR 38.8 · χ² 899 / p 1e-197	37.0 EB05 26.5 · IC025 +3.8 3/3 methods agree	Not in label — unassessed	serious PRR 37.3 · ♀ 4% (drug 44%) · 100% clinician	no trial data cached
Hyponatraemia (low sodium)	118	34.8 29.3–41.3ROR 38.3 · χ² 3,841 / p <1e-300	34.5 EB05 29.6 · IC025 +4.6 3/3 methods agree	Not in label — unassessed	serious PRR 21.2 · ♀ 8% (drug 44%) · 94% clinician	no trial data cached
Anhedonia	55	34.4 26.6–44.6ROR 35.9 · χ² 1,749 / p <1e-300	34.0 EB05 27.1 · IC025 +4.3 3/3 methods agree	Not in label — unassessed	serious PRR 22.2	no trial data cached
Renal injury	53	29.2 22.5–38.1ROR 30.5 · χ² 1,417 / p <1e-300	28.9 EB05 23.0 · IC025 +4.1 3/3 methods agree	Not in label — unassessed	serious PRR 17.4	no trial data cached
Blood cholesterol increased	72	25.6 20.4–32.0ROR 27.0 · χ² 1,676 / p <1e-300	25.4 EB05 20.8 · IC025 +4.1 3/3 methods agree	Lab value / disease marker	serious PRR 23.0 · ♀ 8% (drug 44%) · 94% clinician	no trial data cached
Chronic obstructive pulmonary disease	79	25.1 20.3–31.1ROR 26.7 · χ² 1,805 / p <1e-300	24.9 EB05 20.6 · IC025 +4.1 3/3 methods agree	Not in label — unassessed	serious PRR 17.4 · ♀ 9% (drug 44%) · 94% clinician	no trial data cached
Myocardial ischaemia	17	24.5 15.3–39.4ROR 24.9 · χ² 360 / p 1e-80	23.9 EB05 15.7 · IC025 +3.1 3/3 methods agree	Not in label — unassessed	serious PRR 14.6	no trial data cached
Joint injury	28	21.7 15.0–31.3ROR 22.1 · χ² 532 / p 6e-118	21.4 EB05 15.5 · IC025 +3.4 3/3 methods agree	Not in label — unassessed	serious PRR 16.7 · ♀ 4% (drug 44%) · 100% clinician	no trial data cached
Transaminases increased	29	21.6 15.1–31.0ROR 22.1 · χ² 550 / p 8e-122	21.3 EB05 15.5 · IC025 +3.4 3/3 methods agree	Not in label — unassessed	serious PRR 13.7 · ♀ 8% (drug 44%) · 93% clinician	no trial data cached
Sepsis (blood infection)	141	20.9 17.9–24.4ROR 23.4 · χ² 2,665 / p <1e-300	20.8 EB05 18.1 · IC025 +4.0 3/3 methods agree	Not in label — unassessed	serious PRR 12.5 · ♀ 16% (drug 44%) · 95% clinician	no trial data cached
Toxic epidermal necrolysis (severe skin peeling reaction)	19	20.9 13.3–32.6ROR 21.2 · χ² 339 / p 4e-76	20.4 EB05 13.7 · IC025 +3.0 3/3 methods agree	Not in label — unassessed	serious PRR 12.4	no trial data cached
Injury	83	19.4 15.8–23.9ROR 20.7 · χ² 1,437 / p <1e-300	19.3 EB05 16.1 · IC025 +3.8 3/3 methods agree	Not in label — unassessed	serious PRR 14.2	no trial data cached
General physical health deterioration	127	18.3 15.5–21.6ROR 20.2 · χ² 2,069 / p <1e-300	18.2 EB05 15.7 · IC025 +3.8 3/3 methods agree	Reporting / coding artifact	serious PRR 12.7 · ♀ 9% (drug 44%) · 93% clinician	no trial data cached
Diabetes mellitus	80	17.3 14.0–21.4ROR 18.4 · χ² 1,215 / p 2e-266	17.2 EB05 14.2 · IC025 +3.6 3/3 methods agree	Not in label — unassessed	serious PRR 11.2 · ♀ 6% (drug 44%) · 94% clinician	no trial data cached
Abdominal distension (bloating)	106	16.9 14.1–20.3ROR 18.3 · χ² 1,573 / p <1e-300	16.8 EB05 14.3 · IC025 +3.7 3/3 methods agree	Not in label — unassessed	serious PRR 17.7 · ♀ 7% (drug 44%) · 92% clinician	no trial data cached
Unevaluable event	77	16.8 13.6–20.9ROR 17.9 · χ² 1,135 / p 5e-249	16.7 EB05 13.8 · IC025 +3.6 3/3 methods agree	Reporting / coding artifact	serious PRR 17.5	no trial data cached
Dry mouth	81	16.6 13.4–20.4ROR 17.6 · χ² 1,172 / p 4e-257	16.5 EB05 13.6 · IC025 +3.5 3/3 methods agree	Not in label — unassessed	serious PRR 19.5 · ♀ 7% (drug 44%) · 95% clinician	no trial data cached
Disseminated intravascular coagulation	14	16.4 9.7–27.6ROR 16.6 · χ² 187 / p 6e-43	15.5 EB05 9.1 · IC025 +2.5 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious PRR 9.8	no trial data cached
Obstructive airways disorder	11	16.3 9.1–29.4ROR 16.4 · χ² 143 / p 3e-33	15.0 EB05 7.9 · IC025 +2.3 3/3 methods agree	Not in label — unassessed	serious PRR 10.1	no trial data cached
Coronary artery disease	30	16.3 11.4–23.2ROR 16.6 · χ² 415 / p 1e-92	16.0 EB05 11.6 · IC025 +3.1 3/3 methods agree	Not in label — unassessed	serious PRR 9.8 · ♀ 4% (drug 44%) · 100% clinician	no trial data cached
Thrombosis	79	16.2 13.1–20.1ROR 17.2 · χ² 1,115 / p 8e-245	16.1 EB05 13.3 · IC025 +3.5 3/3 methods agree	Not in label — unassessed	serious PRR 10.0 · ♀ 10% (drug 44%) · 94% clinician	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
Death	269	5.2 4.6–5.7ROR 6.3 · χ² 938 / p 3e-206	5.1 EB05 4.6 · IC025 +2.2 3/3 methods agree	Outcome field, not a reaction	serious PRR 3.1 · 92% clinician	no trial data cached
Stress	167	38.5 33.4–44.3ROR 44.2 · χ² 6,066 / p <1e-300	38.2 EB05 33.6 · IC025 +4.9 3/3 methods agree	Not in label — unassessed	serious PRR 37.7 · ♀ 16% (drug 44%)	no trial data cached
Sepsis (blood infection)	141	20.9 17.9–24.4ROR 23.4 · χ² 2,665 / p <1e-300	20.8 EB05 18.1 · IC025 +4.0 3/3 methods agree	Not in label — unassessed	serious PRR 12.5 · ♀ 16% (drug 44%) · 95% clinician	no trial data cached
Multiple organ dysfunction syndrome	135	80.4 68.5–94.3ROR 89.8 · χ² 10,467 / p <1e-300	79.1 EB05 68.5 · IC025 +5.7 3/3 methods agree	Not in label — unassessed	serious PRR 47.5 · ♀ 11% (drug 44%) · 94% clinician	no trial data cached
General physical health deterioration	127	18.3 15.5–21.6ROR 20.2 · χ² 2,069 / p <1e-300	18.2 EB05 15.7 · IC025 +3.8 3/3 methods agree	Reporting / coding artifact	serious PRR 12.7 · ♀ 9% (drug 44%) · 93% clinician	no trial data cached
Cardiogenic shock	123	143.8 121.5–170.2ROR 159.1 · χ² 17,158 / p <1e-300	139.5 EB05 120.0 · IC025 +6.2 3/3 methods agree	Not in label — unassessed	serious PRR 84.7 · ♀ 14% (drug 44%) · 92% clinician	no trial data cached
Hyponatraemia (low sodium)	118	34.8 29.3–41.3ROR 38.3 · χ² 3,841 / p <1e-300	34.5 EB05 29.6 · IC025 +4.6 3/3 methods agree	Not in label — unassessed	serious PRR 21.2 · ♀ 8% (drug 44%) · 94% clinician	no trial data cached
Ascites	113	63.8 53.5–76.1ROR 69.9 · χ² 6,902 / p <1e-300	62.9 EB05 53.7 · IC025 +5.3 3/3 methods agree	Not in label — unassessed	serious PRR 38.3 · ♀ 9% (drug 44%) · 94% clinician	no trial data cached
Ventricular fibrillation	113	169.5 142.0–202.3ROR 186.0 · χ² 18,577 / p <1e-300	163.2 EB05 139.4 · IC025 +6.3 3/3 methods agree	Labeled (related wording) related wording	serious PRR 100.0 · ♀ 12% (drug 44%) · 93% clinician	no trial data cached
Abdominal distension (bloating)	106	16.9 14.1–20.3ROR 18.3 · χ² 1,573 / p <1e-300	16.8 EB05 14.3 · IC025 +3.7 3/3 methods agree	Not in label — unassessed	serious PRR 17.7 · ♀ 7% (drug 44%) · 92% clinician	no trial data cached
Appendicitis	104	187.1 155.5–225.2ROR 203.7 · χ² 18,859 / p <1e-300	179.0 EB05 151.9 · IC025 +6.3 3/3 methods agree	Not in label — unassessed	serious PRR 111.6 · ♀ 5% (drug 44%) · 93% clinician	no trial data cached
Somnolence (drowsiness)	95	7.8 6.4–9.5ROR 8.4 · χ² 563 / p 9e-125	7.6 EB05 6.4 · IC025 +2.6 3/3 methods agree	Not in label — unassessed	serious PRR 8.1 · ♀ 6% (drug 44%) · 96% clinician	no trial data cached
Renal failure (kidney failure)	89	11.0 9.0–13.5ROR 11.8 · χ² 804 / p 3e-177	10.8 EB05 9.0 · IC025 +3.0 3/3 methods agree	Not in label — unassessed	serious PRR 6.6	no trial data cached
Drug hypersensitivity	86	7.3 6.0–9.0ROR 7.8 · χ² 468 / p 5e-104	7.1 EB05 5.9 · IC025 +2.5 3/3 methods agree	Not in label — unassessed	serious PRR 11.7 · ♀ 12% (drug 44%) · 92% clinician	no trial data cached
Atrial fibrillation	86	14.6 11.9–17.9ROR 15.6 · χ² 1,079 / p 5e-237	14.5 EB05 12.1 · IC025 +3.4 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 9.0 · 97% 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.

Appendicitis — n=104, PRR 187.1
Cardiogenic shock — n=123, PRR 143.8
Multiple organ dysfunction syndrome — n=135, PRR 80.4
Bacterial infection — n=77, PRR 68.8
Hyperlipidaemia — n=47, PRR 65.1
Ascites — n=113, PRR 63.8
Neuralgia — n=78, PRR 53.4
Ulcer — n=51, PRR 53.1
Aspiration — n=31, PRR 47.4
Gout — n=50, PRR 46.1

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 Dobutamine?

In FDA FAERS, the most frequently co-reported reaction terms for Dobutamine are stress, sepsis, multiple organ dysfunction syndrome, cardiogenic shock, hyponatraemia, ascites. 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, field patient.drug.openfda.generic_name.exact, 80 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.