Drug · FAERS side-effect profile with label screen
Dopamine Hydrochloride side effects: what 3,762 FDA adverse event reports show
Who reports
3,762 reports · 95% serious · 1,314 with death outcome · 47% female
openFDA FAERS counts, all years, deduplication not applied
Used for
SECTION Law of similars - Use according to standard homeopathic indications.
FDA label, Indications and Usage
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
Lab value / disease marker 4No label text to screen 36
What the badges mean
- 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.
- No label text to screen No validated FDA label was retrievable for this product, so the screen could not run. Disproportionality only.
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. 209 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 | 105 | 41.3 34.2–49.9ROR 42.5 · χ² 4,062 / p <1e-300 | 40.7 EB05 34.6 · IC025 +4.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 24.8 · 99% clinician | no trial data cached |
| Ventricular fibrillation | 59 | 29.7 23.0–38.3ROR 30.1 · χ² 1,599 / p <1e-300 | 29.3 EB05 23.5 · IC025 +4.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 17.9 · 94% clinician | no trial data cached |
| Multi-organ failure | 88 | 28.1 22.8–34.6ROR 28.7 · χ² 2,263 / p <1e-300 | 27.8 EB05 23.3 · IC025 +4.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 16.9 | no trial data cached |
| Shock | 108 | 26.5 22.0–31.9ROR 27.3 · χ² 2,615 / p <1e-300 | 26.3 EB05 22.4 · IC025 +4.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 15.9 · 93% clinician | no trial data cached |
| Ventricular tachycardia | 74 | 25.0 19.9–31.3ROR 25.5 · χ² 1,674 / p <1e-300 | 24.8 EB05 20.4 · IC025 +4.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 15.2 · 93% clinician | no trial data cached |
| Disseminated intravascular coagulation | 57 | 22.6 17.4–29.2ROR 22.9 · χ² 1,150 / p 2e-252 | 22.4 EB05 17.9 · IC025 +3.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 13.7 · 96% clinician | no trial data cached |
| Multiple organ dysfunction syndrome | 108 | 21.7 18.0–26.1ROR 22.3 · χ² 2,101 / p <1e-300 | 21.5 EB05 18.3 · IC025 +4.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 12.9 · 91% clinician | no trial data cached |
| Blood urea increased | 65 | 21.6 17.0–27.5ROR 22.0 · χ² 1,253 / p 1e-274 | 21.4 EB05 17.4 · IC025 +3.8 3/3 methods agree | Lab value / disease marker | serious PRR 14.2 · 98% clinician | no trial data cached |
| Neutrophil count increased | 37 | 20.1 14.6–27.8ROR 20.3 · χ² 652 / p 5e-144 | 19.9 EB05 15.0 · IC025 +3.5 3/3 methods agree | Lab value / disease marker | serious PRR 13.3 · 97% clinician | no trial data cached |
| Metabolic acidosis | 110 | 19.4 16.2–23.4ROR 20.0 · χ² 1,901 / p <1e-300 | 19.3 EB05 16.5 · IC025 +3.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 11.8 · 93% clinician | no trial data cached |
| Toxic epidermal necrolysis (severe skin peeling reaction) | 44 | 16.3 12.2–21.9ROR 16.5 · χ² 616 / p 3e-136 | 16.1 EB05 12.4 · IC025 +3.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 9.8 · 91% clinician | no trial data cached |
| Sinus bradycardia | 28 | 16.2 11.2–23.4ROR 16.3 · χ² 382 / p 2e-85 | 15.8 EB05 11.3 · IC025 +3.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 10.0 · 92% clinician | no trial data cached |
| Lymphocyte count decreased | 48 | 15.2 11.4–20.1ROR 15.3 · χ² 620 / p 4e-137 | 15.0 EB05 11.7 · IC025 +3.2 3/3 methods agree | Lab value / disease marker | serious PRR 11.2 · 96% clinician | no trial data cached |
| Pulmonary hypertension | 54 | 14.4 11.1–18.8ROR 14.6 · χ² 660 / p 6e-146 | 14.2 EB05 11.2 · IC025 +3.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 8.8 · 96% clinician | no trial data cached |
| Bradycardia (slow heart rate) | 134 | 14.1 11.9–16.6ROR 14.6 · χ² 1,617 / p <1e-300 | 14.0 EB05 12.1 · IC025 +3.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 8.7 · 94% clinician | no trial data cached |
| Cardiac arrest (heart stopping) | 208 | 14.0 12.3–16.0ROR 14.8 · χ² 2,507 / p <1e-300 | 14.0 EB05 12.4 · IC025 +3.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 8.5 · 92% clinician | no trial data cached |
| Coagulopathy | 41 | 13.8 10.2–18.7ROR 13.9 · χ² 473 / p 4e-105 | 13.5 EB05 10.2 · IC025 +3.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 8.5 · 91% clinician | no trial data cached |
| Generalised oedema | 30 | 13.6 9.5–19.4ROR 13.7 · χ² 337 / p 1e-75 | 13.2 EB05 9.4 · IC025 +2.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 9.1 · 96% clinician | no trial data cached |
| Hyperbilirubinaemia | 25 | 13.6 9.2–20.0ROR 13.6 · χ² 278 / p 1e-62 | 13.0 EB05 8.9 · IC025 +2.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 8.3 · 91% clinician | no trial data cached |
| Acute respiratory failure | 45 | 13.1 9.8–17.6ROR 13.3 · χ² 491 / p 4e-109 | 12.8 EB05 9.8 · IC025 +3.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 8.0 · 93% clinician | no trial data cached |
| Myocardial ischaemia | 26 | 12.7 8.6–18.6ROR 12.7 · χ² 267 / p 2e-60 | 12.1 EB05 8.3 · IC025 +2.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.7 · 100% clinician | no trial data cached |
| Sinus tachycardia | 32 | 12.6 8.9–17.8ROR 12.7 · χ² 330 / p 5e-74 | 12.2 EB05 8.8 · IC025 +2.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.8 | no trial data cached |
| Circulatory collapse | 38 | 12.4 9.0–17.0ROR 12.5 · χ² 387 / p 2e-86 | 12.0 EB05 8.9 · IC025 +2.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.5 · ♀ 70% (drug 47%) · 92% clinician | no trial data cached |
| Lactic acidosis | 70 | 12.2 9.7–15.4ROR 12.4 · χ² 707 / p 5e-156 | 12.0 EB05 9.7 · IC025 +3.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.4 · 91% clinician | no trial data cached |
| Renal injury | 64 | 11.9 9.3–15.2ROR 12.1 · χ² 628 / p 7e-139 | 11.7 EB05 9.4 · IC025 +3.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.2 | no trial data cached |
| Status epilepticus | 24 | 11.8 7.9–17.7ROR 11.9 · χ² 227 / p 1e-51 | 11.1 EB05 7.5 · IC025 +2.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.2 · ♀ 91% (drug 47%) | no trial data cached |
| Respiratory depression | 26 | 11.8 8.1–17.4ROR 11.9 · χ² 247 / p 6e-56 | 11.2 EB05 7.7 · IC025 +2.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.1 · ♀ 70% (drug 47%) · 100% clinician | no trial data cached |
| Ventricular extrasystoles | 22 | 11.8 7.8–17.9ROR 11.9 · χ² 207 / p 4e-47 | 11.0 EB05 7.3 · IC025 +2.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.6 | no trial data cached |
| Acute respiratory distress syndrome | 37 | 11.7 8.5–16.1ROR 11.8 · χ² 350 / p 2e-78 | 11.2 EB05 8.3 · IC025 +2.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.7 · 100% clinician | no trial data cached |
| Septic shock | 89 | 11.5 9.4–14.1ROR 11.8 · χ² 843 / p 1e-185 | 11.3 EB05 9.4 · IC025 +3.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.9 · 93% clinician | no trial data cached |
| Renal tubular necrosis | 20 | 11.4 7.3–17.6ROR 11.4 · χ² 178 / p 5e-41 | 10.4 EB05 6.7 · IC025 +2.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.9 | no trial data cached |
| Renal failure acute | 85 | 11.0 8.9–13.6ROR 11.3 · χ² 765 / p 1e-168 | 10.8 EB05 9.0 · IC025 +3.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.7 | no trial data cached |
| Hypoxia (low oxygen) | 69 | 11.0 8.7–13.9ROR 11.2 · χ² 616 / p 3e-136 | 10.7 EB05 8.7 · IC025 +3.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.7 | no trial data cached |
| Hypotension (low blood pressure) | 391 | 10.9 9.9–12.0ROR 12.0 · χ² 3,533 / p <1e-300 | 10.8 EB05 10.0 · IC025 +3.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.6 · 93% clinician | no trial data cached |
| Blood calcium decreased | 22 | 10.9 7.2–16.5ROR 10.9 · χ² 188 / p 6e-43 | 10.0 EB05 6.6 · IC025 +2.4 3/3 methods agree | Lab value / disease marker | serious PRR 7.9 · ♀ 90% (drug 47%) · 90% clinician | no trial data cached |
| Supraventricular tachycardia | 18 | 10.5 6.6–16.7ROR 10.6 · χ² 145 / p 9e-34 | 9.4 EB05 5.9 · IC025 +2.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.7 | no trial data cached |
| Respiratory failure | 137 | 10.5 8.9–12.4ROR 10.8 · χ² 1,167 / p 4e-256 | 10.3 EB05 8.9 · IC025 +3.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.3 · 91% clinician | no trial data cached |
| Fear | 50 | 10.3 7.8–13.6ROR 10.4 · χ² 410 / p 2e-91 | 9.9 EB05 7.7 · IC025 +2.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 8.4 | no trial data cached |
| Pulmonary oedema | 77 | 9.6 7.7–12.0ROR 9.8 · χ² 584 / p 2e-129 | 9.3 EB05 7.6 · IC025 +2.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.9 · 99% clinician | no trial data cached |
| Pulmonary arterial hypertension | 25 | 9.6 6.5–14.2ROR 9.6 · χ² 183 / p 4e-42 | 8.7 EB05 6.0 · IC025 +2.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.9 · ♀ 92% (drug 47%) | 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) | 618 | 2.6 2.4–2.8ROR 2.9 · χ² 657 / p 4e-145 | 2.6 EB05 2.4 · IC025 +1.3 3/3 methods agree | Reporting / coding artifact | serious PRR 4.4 · 95% clinician | no trial data cached |
| Hypotension (low blood pressure) | 391 | 10.9 9.9–12.0ROR 12.0 · χ² 3,533 / p <1e-300 | 10.8 EB05 10.0 · IC025 +3.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.6 · 93% clinician | no trial data cached |
| Cardiac arrest (heart stopping) | 208 | 14.0 12.3–16.0ROR 14.8 · χ² 2,507 / p <1e-300 | 14.0 EB05 12.4 · IC025 +3.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 8.5 · 92% clinician | no trial data cached |
| Acute kidney injury (sudden kidney damage) | 198 | 7.3 6.3–8.3ROR 7.6 · χ² 1,068 / p 2e-234 | 7.1 EB05 6.3 · IC025 +2.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.3 · 96% clinician | no trial data cached |
| Renal failure (kidney failure) | 197 | 8.2 7.2–9.4ROR 8.6 · χ² 1,248 / p 1e-273 | 8.1 EB05 7.2 · IC025 +2.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.0 | no trial data cached |
| Condition aggravated | 168 | 3.1 2.7–3.6ROR 3.2 · χ² 241 / p 1e-54 | 3.1 EB05 2.7 · IC025 +1.4 3/3 methods agree | Reporting / coding artifact | serious PRR 2.8 · 92% clinician | no trial data cached |
| Sepsis (blood infection) | 149 | 7.5 6.4–8.7ROR 7.7 · χ² 829 / p 1e-182 | 7.3 EB05 6.4 · IC025 +2.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.5 · 96% clinician | no trial data cached |
| Renal impairment | 138 | 9.2 7.8–10.8ROR 9.5 · χ² 1,004 / p 1e-220 | 9.0 EB05 7.8 · IC025 +2.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.8 | no trial data cached |
| Respiratory failure | 137 | 10.5 8.9–12.4ROR 10.8 · χ² 1,167 / p 4e-256 | 10.3 EB05 8.9 · IC025 +3.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.3 · 91% clinician | no trial data cached |
| Toxicity to various agents | 135 | 4.5 3.8–5.3ROR 4.6 · χ² 365 / p 1e-81 | 4.4 EB05 3.8 · IC025 +1.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 2.8 · 98% clinician | no trial data cached |
| Bradycardia (slow heart rate) | 134 | 14.1 11.9–16.6ROR 14.6 · χ² 1,617 / p <1e-300 | 14.0 EB05 12.1 · IC025 +3.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 8.7 · 94% clinician | no trial data cached |
| Cardiac failure (heart failure) | 127 | 8.8 7.4–10.5ROR 9.1 · χ² 875 / p 1e-192 | 8.6 EB05 7.4 · IC025 +2.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.3 · 95% clinician | no trial data cached |
| Drug interaction | 114 | 4.0 3.3–4.8ROR 4.1 · χ² 256 / p 6e-58 | 3.9 EB05 3.4 · IC025 +1.7 3/3 methods agree | Reporting / coding artifact | serious PRR 2.7 | no trial data cached |
| Anaemia (low red blood cells) | 112 | 3.3 2.7–3.9ROR 3.3 · χ² 176 / p 2e-40 | 3.2 EB05 2.8 · IC025 +1.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 2.2 · 91% clinician | no trial data cached |
| Metabolic acidosis | 110 | 19.4 16.2–23.4ROR 20.0 · χ² 1,901 / p <1e-300 | 19.3 EB05 16.5 · IC025 +3.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 11.8 · 93% clinician | no trial data cached |
Unlabeled candidate signals
Every screened signal with n ≥ 20 was either labeled, an indication term, or an artifact pattern — no unlabeled candidate stood out in the top signals.
✓ A hand-written Bradford Hill causality assessment exists for this drug: Pramipexole (dopamine agonists) ↔ Impulse-control disorder.
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 Dopamine?
In FDA FAERS, the most frequently co-reported reaction terms for Dopamine are hypotension, cardiac arrest, acute kidney injury, renal failure, sepsis, renal impairment. 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 Dopamine have an FDA boxed warning?
No. The FDA label retrieved for Dopamine has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Dopamine 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 9e02d6dd-97c1-7277-e053-2995a90a112d, effective 20250210; matched on
openfda.generic_name.exact:"DOPAMINE") - 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, 249 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.