Drug · FAERS side-effect profile with label screen
Dexmedetomidine side effects: what 3,369 FDA adverse event reports show
Drug class
Alpha 2 -adrenergic receptor agonist
FDA label, Indications wording
Who reports
3,369 reports · 94% serious · 390 with death outcome · 42% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Dexmedetomidine injection is a alpha 2 -adrenergic receptor agonist indicated for: • Sedation of initially intubated and mechanically ventilated adult patients during treatment in an intensive care setting. Administer dexmedetomidine injection by continuous infusion not to exceed 24 hours. ( 1.1 ) • Sedation of non-intubated adult patients prior to and/or during surgical and other procedures.
FDA label, Indications and Usage
What it is
Dexmedetomidine injection, USP (100 mcg/mL) is a sterile, nonpyrogenic solution suitable for intravenous infusion following dilution. Dexmedetomidine injection contains dexmedetomidine hydrochloride as the active pharmaceutical ingredient. Dexmedetomidine hydrochloride is a central alpha 2 -adrenergic agonist.
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 13Labeled (related wording) 4Reporting / coding artifact 2Not in label — unassessed 21
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.
- 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.
- 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. 102 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 |
|---|---|---|---|---|---|---|
| Bradycardia (slow heart rate) | 222 | 26.1 23.0–29.7ROR 27.9 · χ² 5,327 / p <1e-300 | 26.0 EB05 23.2 · IC025 +4.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 15.8 · 97% clinician | no trial data cached |
| Serotonin syndrome | 75 | 24.5 19.6–30.7ROR 25.0 · χ² 1,662 / p <1e-300 | 24.3 EB05 20.0 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious PRR 15.1 · 100% clinician | no trial data cached |
| Delirium | 125 | 22.6 19.0–26.8ROR 23.4 · χ² 2,551 / p <1e-300 | 22.4 EB05 19.3 · IC025 +4.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 14.0 · 98% clinician | no trial data cached |
| Respiratory depression | 44 | 22.4 16.7–30.1ROR 22.7 · χ² 876 / p 8e-193 | 22.1 EB05 17.2 · IC025 +3.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 14.1 · 95% clinician | no trial data cached |
| Tachypnoea | 48 | 22.1 16.7–29.3ROR 22.4 · χ² 944 / p 1e-207 | 21.9 EB05 17.2 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious PRR 13.9 · ♀ 22% (drug 42%) · 93% clinician | no trial data cached |
| Neuroleptic malignant syndrome | 41 | 21.5 15.9–29.2ROR 21.8 · χ² 780 / p 6e-172 | 21.3 EB05 16.3 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious PRR 13.2 · 100% clinician | no trial data cached |
| Myoclonus | 41 | 21.5 15.8–29.1ROR 21.7 · χ² 778 / p 2e-171 | 21.2 EB05 16.3 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious PRR 13.8 · ♀ 63% (drug 42%) · 98% clinician | no trial data cached |
| Posterior reversible encephalopathy syndrome | 26 | 17.0 11.6–25.0ROR 17.2 · χ² 376 / p 5e-84 | 16.7 EB05 11.8 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 10.4 · ♀ 83% (drug 42%) · 96% clinician | no trial data cached |
| Sinus bradycardia | 23 | 14.8 9.9–22.3ROR 14.9 · χ² 282 / p 1e-63 | 14.3 EB05 9.7 · IC025 +2.8 3/3 methods agree | Labeled (related wording) related wording | serious PRR 8.9 · 100% clinician | no trial data cached |
| Generalised tonic-clonic seizure | 36 | 13.7 9.9–19.0ROR 13.9 · χ² 411 / p 9e-92 | 13.4 EB05 9.9 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 8.5 · ♀ 67% (drug 42%) · 94% clinician | no trial data cached |
| Agitation | 153 | 13.0 11.1–15.1ROR 13.5 · χ² 1,678 / p <1e-300 | 12.9 EB05 11.2 · IC025 +3.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 10.0 · 98% clinician | no trial data cached |
| Hypothermia | 21 | 12.9 8.4–19.8ROR 13.0 · χ² 219 / p 9e-50 | 12.2 EB05 7.9 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 8.0 · 95% clinician | no trial data cached |
| Electrocardiogram qt prolonged | 73 | 12.6 10.1–15.9ROR 12.9 · χ² 771 / p 5e-170 | 12.5 EB05 10.2 · IC025 +3.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.6 · 97% clinician | no trial data cached |
| Rebound effect | 22 | 12.1 8.0–18.4ROR 12.2 · χ² 213 / p 2e-48 | 11.3 EB05 7.5 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 11.9 · 100% clinician | no trial data cached |
| Drug ineffective for unapproved indication | 102 | 11.4 9.4–13.8ROR 11.7 · χ² 959 / p 7e-211 | 11.2 EB05 9.5 · IC025 +3.1 3/3 methods agree | Reporting / coding artifact | serious PRR 14.8 · 99% clinician | no trial data cached |
| Hypoxia (low oxygen) | 62 | 11.0 8.6–14.1ROR 11.2 · χ² 555 / p 5e-123 | 10.7 EB05 8.6 · IC025 +2.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.7 · 100% clinician | no trial data cached |
| Status epilepticus | 20 | 11.0 7.1–17.1ROR 11.1 · χ² 172 / p 1e-39 | 10.0 EB05 6.5 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 6.7 | no trial data cached |
| Cardiac arrest (heart stopping) | 146 | 11.0 9.4–12.9ROR 11.4 · χ² 1,318 / p 7e-289 | 10.9 EB05 9.4 · IC025 +3.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.6 · 94% clinician | no trial data cached |
| Respiratory failure | 128 | 10.9 9.2–13.0ROR 11.3 · χ² 1,147 / p 9e-252 | 10.8 EB05 9.3 · IC025 +3.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.7 · 95% clinician | no trial data cached |
| Acute respiratory distress syndrome | 30 | 10.6 7.4–15.1ROR 10.7 · χ² 250 / p 1e-56 | 9.9 EB05 7.0 · IC025 +2.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.5 · 100% clinician | no trial data cached |
| Withdrawal syndrome | 71 | 10.5 8.3–13.2ROR 10.7 · χ² 600 / p 1e-132 | 10.2 EB05 8.3 · IC025 +2.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 9.1 · 91% clinician | no trial data cached |
| Ventricular tachycardia | 27 | 10.2 7.0–14.8ROR 10.2 · χ² 214 / p 1e-48 | 9.4 EB05 6.6 · IC025 +2.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.3 | no trial data cached |
| Acute respiratory failure | 29 | 9.4 6.6–13.6ROR 9.5 · χ² 210 / p 6e-48 | 8.7 EB05 6.2 · IC025 +2.4 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.8 · 92% clinician | no trial data cached |
| Mental status changes | 41 | 9.2 6.8–12.5ROR 9.3 · χ² 291 / p 1e-65 | 8.7 EB05 6.6 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 6.2 · 100% clinician | no trial data cached |
| Cardiogenic shock | 20 | 8.7 5.6–13.5ROR 8.8 · χ² 129 / p 3e-30 | 7.7 EB05 5.1 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 5.3 | no trial data cached |
| Neurotoxicity | 24 | 8.6 5.8–12.8ROR 8.7 · χ² 154 / p 1e-35 | 7.7 EB05 5.3 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 5.3 · 91% clinician | no trial data cached |
| Muscle rigidity | 16 | 8.3 5.1–13.6ROR 8.4 · χ² 96 / p 5e-23 | 7.1 EB05 4.5 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 5.7 | no trial data cached |
| Ileus | 16 | 8.1 5.0–13.2ROR 8.1 · χ² 93 / p 3e-22 | 6.9 EB05 4.4 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 5.0 | no trial data cached |
| Aspiration | 14 | 8.1 4.8–13.6ROR 8.1 · χ² 79 / p 2e-19 | 6.7 EB05 4.1 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 5.1 | no trial data cached |
| Multiple organ dysfunction syndrome | 35 | 7.8 5.6–10.9ROR 7.9 · χ² 201 / p 6e-46 | 7.2 EB05 5.4 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 4.8 · ♀ 19% (drug 42%) · 97% clinician | no trial data cached |
| Encephalopathy | 30 | 7.6 5.3–10.9ROR 7.7 · χ² 166 / p 2e-38 | 7.0 EB05 5.1 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 4.7 · 96% clinician | no trial data cached |
| Hypotonia | 12 | 7.5 4.2–13.1ROR 7.5 · χ² 61 / p 3e-15 | 6.0 EB05 3.6 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 5.2 | no trial data cached |
| Ventricular fibrillation | 13 | 7.3 4.2–12.5ROR 7.3 · χ² 64 / p 6e-16 | 6.0 EB05 3.7 · IC025 +1.6 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.5 | no trial data cached |
| Unresponsive to stimuli | 30 | 7.3 5.1–10.4ROR 7.3 · χ² 156 / p 4e-36 | 6.6 EB05 4.8 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 4.4 · ♀ 22% (drug 42%) · 93% clinician | no trial data cached |
| Supraventricular tachycardia | 11 | 7.2 4.0–12.9ROR 7.2 · χ² 52 / p 2e-13 | 5.7 EB05 3.4 · IC025 +1.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.2 | no trial data cached |
| Tachycardia (fast heart rate) | 100 | 7.0 5.8–8.5ROR 7.2 · χ² 511 / p 2e-113 | 6.8 EB05 5.8 · IC025 +2.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.5 · 96% clinician | no trial data cached |
| Drug interaction | 171 | 6.7 5.8–7.8ROR 7.0 · χ² 831 / p 4e-183 | 6.6 EB05 5.8 · IC025 +2.5 3/3 methods agree | Reporting / coding artifact | serious PRR 4.6 · 99% clinician | no trial data cached |
| Premature delivery | 17 | 6.6 4.1–10.6ROR 6.6 · χ² 76 / p 2e-18 | 5.7 EB05 3.8 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 4.1 | no trial data cached |
| Toxic epidermal necrolysis (severe skin peeling reaction) | 16 | 6.6 4.1–10.8ROR 6.6 · χ² 71 / p 2e-17 | 5.7 EB05 3.7 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 4.0 | no trial data cached |
| Respiratory distress | 29 | 6.5 4.6–9.4ROR 6.6 · χ² 131 / p 1e-30 | 6.0 EB05 4.3 · IC025 +2.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.1 · 100% 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 |
|---|---|---|---|---|---|---|
| Off label use (used outside approved label) | 436 | 3.1 2.9–3.4ROR 3.4 · χ² 656 / p 6e-145 | 3.1 EB05 2.9 · IC025 +1.5 3/3 methods agree | Reporting / coding artifact | serious PRR 3.2 · 96% clinician | no trial data cached |
| Bradycardia (slow heart rate) | 222 | 26.1 23.0–29.7ROR 27.9 · χ² 5,327 / p <1e-300 | 26.0 EB05 23.2 · IC025 +4.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 15.8 · 97% clinician | no trial data cached |
| Hypotension (low blood pressure) | 207 | 6.4 5.6–7.3ROR 6.8 · χ² 954 / p 1e-209 | 6.3 EB05 5.7 · IC025 +2.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.5 · 97% clinician | no trial data cached |
| Drug interaction | 171 | 6.7 5.8–7.8ROR 7.0 · χ² 831 / p 4e-183 | 6.6 EB05 5.8 · IC025 +2.5 3/3 methods agree | Reporting / coding artifact | serious PRR 4.6 · 99% clinician | no trial data cached |
| Agitation | 153 | 13.0 11.1–15.1ROR 13.5 · χ² 1,678 / p <1e-300 | 12.9 EB05 11.2 · IC025 +3.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 10.0 · 98% clinician | no trial data cached |
| Cardiac arrest (heart stopping) | 146 | 11.0 9.4–12.9ROR 11.4 · χ² 1,318 / p 7e-289 | 10.9 EB05 9.4 · IC025 +3.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.6 · 94% clinician | no trial data cached |
| Respiratory failure | 128 | 10.9 9.2–13.0ROR 11.3 · χ² 1,147 / p 9e-252 | 10.8 EB05 9.3 · IC025 +3.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.7 · 95% clinician | no trial data cached |
| Delirium | 125 | 22.6 19.0–26.8ROR 23.4 · χ² 2,551 / p <1e-300 | 22.4 EB05 19.3 · IC025 +4.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 14.0 · 98% clinician | no trial data cached |
| Drug ineffective for unapproved indication | 102 | 11.4 9.4–13.8ROR 11.7 · χ² 959 / p 7e-211 | 11.2 EB05 9.5 · IC025 +3.1 3/3 methods agree | Reporting / coding artifact | serious PRR 14.8 · 99% clinician | no trial data cached |
| Tachycardia (fast heart rate) | 100 | 7.0 5.8–8.5ROR 7.2 · χ² 511 / p 2e-113 | 6.8 EB05 5.8 · IC025 +2.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.5 · 96% clinician | no trial data cached |
| Acute kidney injury (sudden kidney damage) | 98 | 4.0 3.3–4.9ROR 4.1 · χ² 220 / p 6e-50 | 3.9 EB05 3.3 · IC025 +1.6 3/3 methods agree | Labeled (related wording) related wording | serious PRR 2.4 · 98% clinician | no trial data cached |
| Toxicity to various agents | 97 | 3.6 3.0–4.4ROR 3.7 · χ² 181 / p 2e-41 | 3.5 EB05 3.0 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 2.3 · 98% clinician | no trial data cached |
| Drug withdrawal syndrome | 77 | 5.4 4.3–6.7ROR 5.5 · χ² 273 / p 1e-61 | 5.2 EB05 4.3 · IC025 +2.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.1 · 99% clinician | no trial data cached |
| Serotonin syndrome | 75 | 24.5 19.6–30.7ROR 25.0 · χ² 1,662 / p <1e-300 | 24.3 EB05 20.0 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious PRR 15.1 · 100% clinician | no trial data cached |
| Electrocardiogram qt prolonged | 73 | 12.6 10.1–15.9ROR 12.9 · χ² 771 / p 5e-170 | 12.5 EB05 10.2 · IC025 +3.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.6 · 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.
- Serotonin syndrome — n=75, PRR 24.5
- Tachypnoea — n=48, PRR 22.1
- Neuroleptic malignant syndrome — n=41, PRR 21.5
- Myoclonus — n=41, PRR 21.5
- Posterior reversible encephalopathy syndrome — n=26, PRR 17.0
- Generalised tonic-clonic seizure — n=36, PRR 13.7
- Hypothermia — n=21, PRR 12.9
- Rebound effect — n=22, PRR 12.1
- Status epilepticus — n=20, PRR 11.0
- Mental status changes — n=41, PRR 9.2
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 Dexmedetomidine?
In FDA FAERS, the most frequently co-reported reaction terms for Dexmedetomidine are bradycardia, hypotension, agitation, cardiac arrest, respiratory failure, delirium. 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 Dexmedetomidine have an FDA boxed warning?
No. The FDA label retrieved for Dexmedetomidine has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Dexmedetomidine 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 714cc0d2-8a4c-40c0-8ef0-dcfde4c46989, effective 20260519; matched on
openfda.generic_name.exact:"DEXMEDETOMIDINE") - 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, 142 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.