OpenPV Signal Explorer
FAERS disproportionality dashboard
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Drug

Dexmedetomidine Hydrochloride

131 flagged reaction(s) · 3,365 total co-reports · max PRR 33.6
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 250 33.6 36.6 signal
2 Respiratory Depression 48 27.9 28.4 signal
3 Ventricular Fibrillation 39 25.0 25.3 signal
4 Sinus Bradycardia 31 22.8 23.0 signal
5 Ventricular Tachycardia 41 17.6 17.9 signal
6 Hypotonia 23 16.3 16.5 signal
7 Myoclonus 26 15.5 15.7 signal
8 Hypothermia 22 15.4 15.6 signal
9 Generalised Tonic-clonic Seizure 34 14.8 15.0 signal
10 Atelectasis 20 14.7 14.8 signal
11 Cardiac Arrest 170 14.6 15.4 signal
12 Tachypnoea 27 14.2 14.3 signal
13 Disseminated Intravascular Coagulation 25 12.6 12.7 signal
14 Neuroleptic Malignant Syndrome 21 12.6 12.7 signal
15 Drug Reaction With Eosinophilia And Systemic Symptoms 44 12.3 12.4 signal
16 Obstructive Airways Disorder 19 12.1 12.2 signal
17 Acute Respiratory Failure 32 11.9 12.0 signal
18 Hypoxia 57 11.6 11.8 signal
19 Multi-organ Failure 28 11.4 11.5 signal
20 Aspiration 17 11.2 11.2 signal
21 Oxygen Saturation Decreased 84 10.7 11.0 signal
22 Cardiogenic Shock 20 10.0 10.0 signal
23 Covid-19 Pneumonia 16 9.6 9.6 signal
24 Altered State Of Consciousness 29 9.6 9.7 signal
25 Ileus 16 9.2 9.3 signal
26 Multiple Organ Dysfunction Syndrome 36 9.2 9.3 signal
27 Pneumonia Aspiration 32 9.1 9.2 signal
28 Supraventricular Tachycardia 12 8.9 9.0 signal
29 Delirium 43 8.8 9.0 signal
30 Septic Shock 52 8.6 8.7 signal
31 Respiratory Failure 86 8.4 8.6 signal
32 Circulatory Collapse 20 8.3 8.4 signal
33 Posterior Reversible Encephalopathy Syndrome 11 8.2 8.2 signal
34 Laceration 11 8.2 8.2 signal
35 Status Epilepticus 13 8.2 8.2 signal
36 Myocardial Ischaemia 13 8.1 8.1 signal
37 Hepatic Function Abnormal 41 7.9 8.0 signal
38 Unresponsive To Stimuli 28 7.7 7.8 signal
39 Agitation 78 7.5 7.7 signal
40 Sinus Tachycardia 15 7.5 7.6 signal
41 Blood Pressure Decreased 70 7.5 7.7 signal
42 Thrombotic Microangiopathy 10 7.3 7.4 signal
43 Acute Respiratory Distress Syndrome 18 7.2 7.3 signal
44 Anaphylactic Shock 26 7.2 7.3 signal
45 Shock 23 7.2 7.2 signal
46 Sedation 26 7.1 7.1 signal
47 Withdrawal Syndrome 42 7.1 7.2 signal
48 Hypertensive Crisis 11 7.0 7.0 signal
49 Rhabdomyolysis 41 7.0 7.1 signal
50 Accidental Overdose 36 7.0 7.1 signal
51 Respiratory Distress 27 7.0 7.0 signal
52 Ventricular Extrasystoles 10 6.8 6.9 signal
53 Heart Rate Decreased 32 6.4 6.5 signal
54 Cerebral Infarction 22 6.4 6.4 signal
55 Respiratory Arrest 25 6.4 6.4 signal
56 Hypotension 177 6.3 6.6 signal
57 Pneumothorax 14 6.3 6.3 signal
58 Cardio-respiratory Arrest 37 6.3 6.3 signal
59 Electrocardiogram Qt Prolonged 31 6.1 6.2 signal
60 Depressed Level Of Consciousness 34 6.1 6.2 signal
61 Encephalopathy 21 6.1 6.1 signal
62 Tachycardia 73 5.8 6.0 signal
63 Intestinal Perforation 9 5.7 5.7 signal
64 Hyperglycaemia 29 5.7 5.7 signal
65 Therapy Partial Responder 12 5.7 5.7 signal
66 Mental Status Changes 22 5.6 5.7 signal
67 Electrolyte Imbalance 9 5.6 5.6 signal
68 Post Procedural Complication 15 5.5 5.6 signal
69 Cytokine Release Syndrome 14 5.2 5.2 signal
70 Toxic Epidermal Necrolysis 11 5.2 5.2 signal
71 Incorrect Route Of Product Administration 12 5.1 5.1 signal
72 Blood Creatine Phosphokinase Increased 19 4.6 4.6 signal
73 Aspartate Aminotransferase Increased 32 4.3 4.3 signal
74 Post Procedural Haemorrhage 7 4.3 4.3 signal
75 Cholestasis 11 4.1 4.1 signal
76 Blood Bilirubin Increased 15 3.9 4.0 signal
77 Fear 15 3.9 3.9 signal
78 Metabolic Acidosis 17 3.8 3.8 signal
79 Pulmonary Hypertension 11 3.7 3.7 signal
80 Syringe Issue 9 3.6 3.7 signal
81 Salivary Hypersecretion 5 3.6 3.6 signal
82 Renal Injury 15 3.6 3.6 signal
83 Drug Withdrawal Syndrome 44 3.5 3.6 signal
84 Restlessness 18 3.5 3.5 signal
85 Pulmonary Oedema 22 3.5 3.5 signal
86 Product Use Issue 91 3.5 3.5 signal
87 Hyperbilirubinaemia 5 3.4 3.5 signal
88 Pulmonary Arterial Hypertension 7 3.4 3.4 signal
89 Febrile Neutropenia 31 3.3 3.4 signal
90 Hepatic Failure 14 3.3 3.3 signal
91 Blood Pressure Fluctuation 11 3.2 3.3 signal
92 Liver Injury 11 3.2 3.2 signal
93 Cerebral Haemorrhage 16 3.2 3.2 signal
94 Bronchospasm 6 3.0 3.0 signal
95 Muscle Rigidity 5 3.0 3.0 signal
96 Hepatic Cytolysis 5 2.9 2.9 signal
97 Melaena 9 2.9 2.9 signal
98 Product Administration Error 8 2.8 2.9 signal
99 Injection Site Extravasation 5 2.8 2.9 signal
100 Anaphylactic Reaction 22 2.8 2.9 signal
101 Brain Injury 4 2.8 2.8 no signal
102 Dyskinesia 16 2.8 2.8 signal
103 Transfusion 4 2.7 2.7 no signal
104 Acute Hepatic Failure 5 2.6 2.6 no signal
105 Serotonin Syndrome 7 2.6 2.6 signal
106 Coma 17 2.5 2.5 signal
107 Anhedonia 9 2.4 2.4 signal
108 Fluid Overload 5 2.4 2.4 no signal
109 Haemorrhage Intracranial 5 2.4 2.4 no signal
110 Interstitial Lung Disease 16 2.4 2.4 signal
111 Unevaluable Event 25 2.3 2.4 signal
112 Diarrhoea Haemorrhagic 3 2.3 2.3 no signal
113 Irritability 19 2.2 2.2 signal
114 Dystonia 6 2.2 2.2 no signal
115 Rash Generalised 8 2.2 2.2 no signal
116 Drug Level Increased 5 2.1 2.1 no signal
117 Premature Baby 9 2.1 2.1 signal
118 Peritonitis 6 2.1 2.1 no signal
119 Dialysis 4 2.0 2.0 no signal
120 Extrapyramidal Disorder 7 2.0 2.0 no signal
121 Toxicity To Various Agents 46 1.9 2.0 no signal
122 Rebound Effect 3 1.9 1.9 no signal
123 Caesarean Section 3 1.8 1.8 no signal
124 Overdose 55 1.8 1.8 no signal
125 Premature Delivery 3 1.3 1.3 no signal
126 Product Preparation Error 3 1.0 1.0 no signal
127 Product Complaint 3 0.9 0.9 no signal
128 Incorrect Dose Administered By Device 3 0.8 0.8 no signal
129 Device Leakage 5 0.8 0.8 no signal
130 Incorrect Drug Administration Duration 3 0.7 0.7 no signal
131 Drug Exposure During Pregnancy 3 0.6 0.6 no signal