Drug · FAERS side-effect profile with label screen
Dexmedetomidine In 0.9% side effects: what 1,743 FDA adverse event reports show
Drug class
Alpha 2 -adrenergic receptor agonist
FDA label, Indications wording of the closest related product
Label matched
Dexmedetomidine (Dexmedetomidine)
closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match
Who reports
1,743 reports · 98% serious · 168 with death outcome · 41% 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 hydrochloride in 0.9% Sodium Chloride Injection (4 mcg/mL) is a sterile, nonpyrogenic ready to use solution suitable for intravenous infusion.
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 11Labeled (related wording) 5Likely indication confounding 1Reporting / coding artifact 3Lab value / disease marker 1Not in label — unassessed 19
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. 22 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) | 180 | 40.9 35.6–47.0ROR 45.5 · χ² 6,959 / p <1e-300 | 40.6 EB05 35.9 · IC025 +5.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 24.8 · 97% clinician | no trial data cached |
| Sinus bradycardia | 30 | 37.4 26.2–53.3ROR 38.0 · χ² 1,023 / p 8e-225 | 36.5 EB05 26.8 · IC025 +3.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 22.6 · 96% clinician | no trial data cached |
| Respiratory depression | 37 | 36.4 26.5–50.1ROR 37.2 · χ² 1,236 / p 5e-271 | 35.7 EB05 27.0 · IC025 +4.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 21.4 · 94% clinician | no trial data cached |
| Ventricular fibrillation | 25 | 27.1 18.3–40.0ROR 27.4 · χ² 601 / p 6e-133 | 26.5 EB05 18.9 · IC025 +3.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 15.9 · 100% clinician | no trial data cached |
| Hypotonia | 22 | 26.4 17.5–40.1ROR 26.8 · χ² 513 / p 8e-114 | 25.9 EB05 18.0 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 17.7 · 100% clinician | no trial data cached |
| Myoclonus | 25 | 25.3 17.1–37.3ROR 25.6 · χ² 558 / p 1e-123 | 24.8 EB05 17.6 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 15.7 · ♀ 71% (drug 41%) · 100% clinician | no trial data cached |
| Generalised tonic-clonic seizure | 33 | 24.3 17.3–34.1ROR 24.8 · χ² 713 / p 2e-157 | 24.0 EB05 17.8 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious PRR 14.5 · ♀ 65% (drug 41%) · 94% clinician | no trial data cached |
| Ventricular tachycardia | 27 | 19.6 13.5–28.5ROR 19.9 · χ² 459 / p 5e-102 | 19.3 EB05 13.9 · IC025 +3.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 11.6 · 96% clinician | no trial data cached |
| Tachypnoea | 22 | 19.6 12.9–29.6ROR 19.8 · χ² 369 / p 2e-82 | 19.2 EB05 13.2 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 11.8 · 95% clinician | no trial data cached |
| Hypothermia | 16 | 19.0 11.7–31.0ROR 19.2 · χ² 255 / p 1e-57 | 18.4 EB05 11.7 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 11.3 | no trial data cached |
| Cardiac arrest (heart stopping) | 107 | 15.6 12.9–18.7ROR 16.5 · χ² 1,446 / p <1e-300 | 15.5 EB05 13.1 · IC025 +3.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 9.1 · 98% clinician | no trial data cached |
| Obstructive airways disorder | 13 | 14.0 8.2–24.1ROR 14.1 · χ² 144 / p 1e-33 | 12.8 EB05 7.1 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 7.9 | no trial data cached |
| Ileus | 14 | 13.7 8.1–23.1ROR 13.8 · χ² 152 / p 3e-35 | 12.5 EB05 7.2 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 8.1 | no trial data cached |
| Aspiration | 12 | 13.3 7.6–23.4ROR 13.4 · χ² 125 / p 3e-29 | 11.8 EB05 6.4 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 8.1 | no trial data cached |
| Posterior reversible encephalopathy syndrome | 10 | 12.7 6.8–23.5ROR 12.7 · χ² 96 / p 6e-23 | 10.6 EB05 5.4 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 7.4 | no trial data cached |
| Oxygen saturation decreased | 58 | 12.5 9.7–16.1ROR 12.9 · χ² 604 / p 1e-133 | 12.3 EB05 9.8 · IC025 +3.1 3/3 methods agree | Lab value / disease marker | serious PRR 7.8 · 97% clinician | no trial data cached |
| Altered state of consciousness | 22 | 12.3 8.1–18.6ROR 12.4 · χ² 217 / p 2e-49 | 11.5 EB05 7.6 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 7.3 · 95% clinician | no trial data cached |
| Hypertensive crisis | 11 | 11.9 6.6–21.4ROR 11.9 · χ² 99 / p 1e-23 | 10.0 EB05 5.3 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 7.0 | no trial data cached |
| Withdrawal syndrome | 41 | 11.7 8.6–15.8ROR 11.9 · χ² 391 / p 3e-87 | 11.3 EB05 8.5 · IC025 +2.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 9.9 · 100% clinician | no trial data cached |
| Accidental overdose | 31 | 10.2 7.2–14.5ROR 10.4 · χ² 249 / p 3e-56 | 9.6 EB05 6.9 · IC025 +2.6 3/3 methods agree | Reporting / coding artifact | serious PRR 9.9 · ♀ 63% (drug 41%) · 97% clinician | no trial data cached |
| Electrocardiogram qt prolonged | 30 | 10.0 7.0–14.3ROR 10.2 · χ² 235 / p 2e-53 | 9.4 EB05 6.7 · IC025 +2.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.0 · 97% clinician | no trial data cached |
| Anaphylactic shock | 21 | 9.9 6.4–15.1ROR 10.0 · χ² 159 / p 1e-36 | 8.9 EB05 5.9 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 5.8 · 100% clinician | no trial data cached |
| Hypoxia (low oxygen) | 28 | 9.6 6.7–13.9ROR 9.8 · χ² 208 / p 2e-47 | 8.9 EB05 6.3 · IC025 +2.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.5 · 96% clinician | no trial data cached |
| Therapy partial responder | 12 | 9.6 5.5–16.9ROR 9.7 · χ² 84 / p 3e-20 | 7.9 EB05 4.5 · IC025 +1.9 3/3 methods agree | Reporting / coding artifact | serious PRR 6.8 | no trial data cached |
| Delirium | 27 | 9.4 6.5–13.7ROR 9.5 · χ² 195 / p 2e-44 | 8.6 EB05 6.0 · IC025 +2.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.6 · ♀ 19% (drug 41%) · 93% clinician | no trial data cached |
| Sinus tachycardia | 11 | 9.3 5.2–16.8ROR 9.4 · χ² 74 / p 4e-18 | 7.5 EB05 4.2 · IC025 +1.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.6 | no trial data cached |
| Cardiogenic shock | 11 | 9.3 5.1–16.7ROR 9.3 · χ² 73 / p 6e-18 | 7.4 EB05 4.2 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 5.4 | no trial data cached |
| Circulatory collapse | 12 | 8.4 4.8–14.8ROR 8.5 · χ² 71 / p 1e-17 | 6.8 EB05 4.0 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 5.0 | no trial data cached |
| Incorrect route of product administration | 11 | 7.9 4.4–14.2ROR 7.9 · χ² 59 / p 7e-15 | 6.3 EB05 3.6 · IC025 +1.6 3/3 methods agree | Reporting / coding artifact | serious PRR 9.3 | no trial data cached |
| Agitation | 47 | 7.7 5.8–10.2ROR 7.9 · χ² 267 / p 2e-60 | 7.3 EB05 5.6 · IC025 +2.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.0 · 96% clinician | no trial data cached |
| Rhabdomyolysis (muscle breakdown) | 26 | 7.5 5.1–11.0ROR 7.6 · χ² 141 / p 9e-33 | 6.8 EB05 4.8 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 4.4 · 92% clinician | no trial data cached |
| Sedation | 16 | 7.4 4.5–12.0ROR 7.4 · χ² 82 / p 6e-20 | 6.3 EB05 4.0 · IC025 +1.8 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 6.0 | no trial data cached |
| Hyperglycaemia (high blood sugar) | 20 | 6.6 4.3–10.2ROR 6.7 · χ² 90 / p 1e-21 | 5.8 EB05 4.0 · IC025 +1.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.4 · 95% clinician | no trial data cached |
| Mental status changes | 15 | 6.5 3.9–10.8ROR 6.5 · χ² 64 / p 5e-16 | 5.5 EB05 3.5 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 4.2 | no trial data cached |
| Respiratory failure | 39 | 6.4 4.7–8.8ROR 6.6 · χ² 174 / p 5e-40 | 6.0 EB05 4.6 · IC025 +2.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.8 · 95% clinician | no trial data cached |
| Shock | 12 | 6.3 3.6–11.1ROR 6.4 · χ² 49 / p 2e-12 | 5.2 EB05 3.2 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 3.7 | no trial data cached |
| Cholestasis (bile flow blockage) | 10 | 6.3 3.4–11.7ROR 6.3 · χ² 39 / p 2e-10 | 5.0 EB05 2.9 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 3.7 | no trial data cached |
| Heart rate decreased | 18 | 6.1 3.9–9.7ROR 6.2 · χ² 72 / p 9e-18 | 5.4 EB05 3.6 · IC025 +1.6 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.5 | no trial data cached |
| Unresponsive to stimuli | 13 | 6.1 3.5–10.5ROR 6.1 · χ² 50 / p 7e-13 | 5.1 EB05 3.2 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 3.4 | no trial data cached |
| Respiratory arrest | 13 | 5.6 3.3–9.7ROR 5.7 · χ² 45 / p 1e-11 | 4.8 EB05 3.0 · IC025 +1.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.3 | 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 |
|---|---|---|---|---|---|---|
| Bradycardia (slow heart rate) | 180 | 40.9 35.6–47.0ROR 45.5 · χ² 6,959 / p <1e-300 | 40.6 EB05 35.9 · IC025 +5.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 24.8 · 97% clinician | no trial data cached |
| Cardiac arrest (heart stopping) | 107 | 15.6 12.9–18.7ROR 16.5 · χ² 1,446 / p <1e-300 | 15.5 EB05 13.1 · IC025 +3.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 9.1 · 98% clinician | no trial data cached |
| Oxygen saturation decreased | 58 | 12.5 9.7–16.1ROR 12.9 · χ² 604 / p 1e-133 | 12.3 EB05 9.8 · IC025 +3.1 3/3 methods agree | Lab value / disease marker | serious PRR 7.8 · 97% clinician | no trial data cached |
| Agitation | 47 | 7.7 5.8–10.2ROR 7.9 · χ² 267 / p 2e-60 | 7.3 EB05 5.6 · IC025 +2.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.0 · 96% clinician | no trial data cached |
| Withdrawal syndrome | 41 | 11.7 8.6–15.8ROR 11.9 · χ² 391 / p 3e-87 | 11.3 EB05 8.5 · IC025 +2.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 9.9 · 100% clinician | no trial data cached |
| Respiratory failure | 39 | 6.4 4.7–8.8ROR 6.6 · χ² 174 / p 5e-40 | 6.0 EB05 4.6 · IC025 +2.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.8 · 95% clinician | no trial data cached |
| Respiratory depression | 37 | 36.4 26.5–50.1ROR 37.2 · χ² 1,236 / p 5e-271 | 35.7 EB05 27.0 · IC025 +4.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 21.4 · 94% clinician | no trial data cached |
| Generalised tonic-clonic seizure | 33 | 24.3 17.3–34.1ROR 24.8 · χ² 713 / p 2e-157 | 24.0 EB05 17.8 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious PRR 14.5 · ♀ 65% (drug 41%) · 94% clinician | no trial data cached |
| Drug withdrawal syndrome | 31 | 4.2 3.0–6.0ROR 4.3 · χ² 73 / p 7e-18 | 4.0 EB05 2.9 · IC025 +1.4 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.1 · 100% clinician | no trial data cached |
| Accidental overdose | 31 | 10.2 7.2–14.5ROR 10.4 · χ² 249 / p 3e-56 | 9.6 EB05 6.9 · IC025 +2.6 3/3 methods agree | Reporting / coding artifact | serious PRR 9.9 · ♀ 63% (drug 41%) · 97% clinician | no trial data cached |
| Electrocardiogram qt prolonged | 30 | 10.0 7.0–14.3ROR 10.2 · χ² 235 / p 2e-53 | 9.4 EB05 6.7 · IC025 +2.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.0 · 97% clinician | no trial data cached |
| Sinus bradycardia | 30 | 37.4 26.2–53.3ROR 38.0 · χ² 1,023 / p 8e-225 | 36.5 EB05 26.8 · IC025 +3.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 22.6 · 96% clinician | no trial data cached |
| Hypoxia (low oxygen) | 28 | 9.6 6.7–13.9ROR 9.8 · χ² 208 / p 2e-47 | 8.9 EB05 6.3 · IC025 +2.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.5 · 96% clinician | no trial data cached |
| Delirium | 27 | 9.4 6.5–13.7ROR 9.5 · χ² 195 / p 2e-44 | 8.6 EB05 6.0 · IC025 +2.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.6 · ♀ 19% (drug 41%) · 93% clinician | no trial data cached |
| Ventricular tachycardia | 27 | 19.6 13.5–28.5ROR 19.9 · χ² 459 / p 5e-102 | 19.3 EB05 13.9 · IC025 +3.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 11.6 · 96% 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.
- Hypotonia — n=22, PRR 26.4
- Myoclonus — n=25, PRR 25.3
- Generalised tonic-clonic seizure — n=33, PRR 24.3
- Tachypnoea — n=22, PRR 19.6
- Altered state of consciousness — n=22, PRR 12.3
- Anaphylactic shock — n=21, PRR 9.9
- Rhabdomyolysis — n=26, PRR 7.5
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 0.9%?
In FDA FAERS, the most frequently co-reported reaction terms for Dexmedetomidine In 0.9% are bradycardia, cardiac arrest, oxygen saturation decreased, agitation, withdrawal syndrome, respiratory failure. 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 In 0.9% have an FDA boxed warning?
No. The FDA label retrieved for Dexmedetomidine In 0.9% has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Dexmedetomidine In 0.9% 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 8c162541-986b-4b30-866c-b2631ba2c975, effective 20260720; matched on
openfda.generic_name.exact:"DEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE") - 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, 62 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.