Drug
Dexmedetomidine Hydrochloride In 0.9% Sodium Chloride
Important: Reactions below are the flagged terms from this drug’s
FAERS report history (min. 3 co-reports per term) — PRR/ROR indicate
disproportionality in spontaneous reporting, not causation.
Data from FDA FAERS via openFDA. Last recalculated: 2026-09-14.
| Reaction | Co-reports (a) | PRR | ROR | Signal | |
|---|---|---|---|---|---|
| 1 | Bradycardia | 180 | 40.9 | 45.5 | signal |
| 2 | Sinus Bradycardia | 30 | 37.4 | 38.0 | signal |
| 3 | Respiratory Depression | 37 | 36.4 | 37.2 | signal |
| 4 | Ventricular Fibrillation | 25 | 27.1 | 27.4 | signal |
| 5 | Hypotonia | 22 | 26.4 | 26.8 | signal |
| 6 | Myoclonus | 25 | 25.3 | 25.6 | signal |
| 7 | Generalised Tonic-clonic Seizure | 33 | 24.3 | 24.8 | signal |
| 8 | Ventricular Tachycardia | 27 | 19.6 | 19.9 | signal |
| 9 | Tachypnoea | 22 | 19.6 | 19.8 | signal |
| 10 | Hypothermia | 16 | 19.0 | 19.2 | signal |
| 11 | Cardiac Arrest | 107 | 15.6 | 16.5 | signal |
| 12 | Obstructive Airways Disorder | 13 | 14.0 | 14.1 | signal |
| 13 | Ileus | 14 | 13.7 | 13.8 | signal |
| 14 | Aspiration | 12 | 13.3 | 13.4 | signal |
| 15 | Posterior Reversible Encephalopathy Syndrome | 10 | 12.7 | 12.7 | signal |
| 16 | Oxygen Saturation Decreased | 58 | 12.5 | 12.9 | signal |
| 17 | Altered State Of Consciousness | 22 | 12.3 | 12.4 | signal |
| 18 | Hypertensive Crisis | 11 | 11.9 | 11.9 | signal |
| 19 | Withdrawal Syndrome | 41 | 11.7 | 11.9 | signal |
| 20 | Atelectasis | 9 | 11.2 | 11.2 | signal |
| 21 | Accidental Overdose | 31 | 10.2 | 10.4 | signal |
| 22 | Electrocardiogram Qt Prolonged | 30 | 10.0 | 10.2 | signal |
| 23 | Anaphylactic Shock | 21 | 9.9 | 10.0 | signal |
| 24 | Hypoxia | 28 | 9.6 | 9.8 | signal |
| 25 | Therapy Partial Responder | 12 | 9.6 | 9.7 | signal |
| 26 | Myocardial Ischaemia | 9 | 9.4 | 9.5 | signal |
| 27 | Delirium | 27 | 9.4 | 9.5 | signal |
| 28 | Sinus Tachycardia | 11 | 9.3 | 9.4 | signal |
| 29 | Cardiogenic Shock | 11 | 9.3 | 9.3 | signal |
| 30 | Neuroleptic Malignant Syndrome | 9 | 9.1 | 9.2 | signal |
| 31 | Circulatory Collapse | 12 | 8.4 | 8.5 | signal |
| 32 | Ventricular Extrasystoles | 7 | 8.1 | 8.1 | signal |
| 33 | Incorrect Route Of Product Administration | 11 | 7.9 | 7.9 | signal |
| 34 | Agitation | 47 | 7.7 | 7.9 | signal |
| 35 | Supraventricular Tachycardia | 6 | 7.6 | 7.6 | signal |
| 36 | Rhabdomyolysis | 26 | 7.5 | 7.6 | signal |
| 37 | Sedation | 16 | 7.4 | 7.4 | signal |
| 38 | Hyperglycaemia | 20 | 6.6 | 6.7 | signal |
| 39 | Mental Status Changes | 15 | 6.5 | 6.5 | signal |
| 40 | Respiratory Failure | 39 | 6.4 | 6.6 | signal |
| 41 | Toxic Epidermal Necrolysis | 8 | 6.4 | 6.4 | signal |
| 42 | Shock | 12 | 6.3 | 6.4 | signal |
| 43 | Cholestasis | 10 | 6.3 | 6.3 | signal |
| 44 | Heart Rate Decreased | 18 | 6.1 | 6.2 | signal |
| 45 | Unresponsive To Stimuli | 13 | 6.1 | 6.1 | signal |
| 46 | Disseminated Intravascular Coagulation | 7 | 6.0 | 6.0 | signal |
| 47 | Respiratory Arrest | 13 | 5.6 | 5.7 | signal |
| 48 | Cerebral Infarction | 11 | 5.4 | 5.4 | signal |
| 49 | Status Epilepticus | 5 | 5.3 | 5.3 | signal |
| 50 | Depressed Level Of Consciousness | 17 | 5.2 | 5.2 | signal |
| 51 | Laceration | 4 | 5.0 | 5.1 | signal |
| 52 | Thrombotic Microangiopathy | 4 | 5.0 | 5.0 | signal |
| 53 | Hepatic Cytolysis | 5 | 4.9 | 4.9 | signal |
| 54 | Drug Reaction With Eosinophilia And Systemic Symptoms | 10 | 4.7 | 4.7 | signal |
| 55 | Drug Withdrawal Syndrome | 31 | 4.2 | 4.3 | signal |
| 56 | Haemorrhage Intracranial | 5 | 4.0 | 4.0 | signal |
| 57 | Dystonia | 6 | 3.7 | 3.7 | signal |
| 58 | Drug Level Increased | 5 | 3.6 | 3.6 | signal |
| 59 | Rebound Effect | 3 | 3.2 | 3.2 | no signal |
| 60 | Extrapyramidal Disorder | 6 | 2.9 | 2.9 | signal |
| 61 | Serotonin Syndrome | 4 | 2.5 | 2.5 | no signal |
| 62 | Premature Baby | 6 | 2.4 | 2.4 | no signal |