What are side effects of Dexmedetomidine?

1.

Food and Drug Administration (DailyMed).

Publish date: May 2, 2023.

Adverse Reactions Hypotension and bradycardia were the most common adverse reactions associated with the use of dexmedetomidine during post approval use of the drug. Table 7: Adverse Reactions Experienced During Post-approval Use of Dexmedetomidine System Organ Class Preferred Term Blood and Lymphatic System Disorders Anemia Cardiac Disorders Arrhythmia, atrial fibrillation, atrioventricular block, bradycardia, cardiac arrest, cardiac disorder, extrasystoles, myocardial infarction, supraventricular tachycardia, tachycardia, ventricular arrhythmia, ventricular tachycardia Eye Disorders Photopsia, visual impairment Gastrointestinal Disorders Abdominal pain, diarrhea, nausea, vomiting General Disorders and Administration Site Conditions Chills, hyperpyrexia, pain, pyrexia, thirst Hepatobiliary Disorders Hepatic function abnormal, hyperbilirubinemia Investigations Alanine aminotransferase increased, aspartate aminotransferase increased, blood alkaline phosphatase increased, blood urea increased, electrocardiogram T wave inversion, gammaglutamyltransferase increased, electrocardiogram QT prolonged Metabolism and Nutrition Disorders Acidosis, hyperkalemia, hypoglycemia, hypovolemia, hypernatremia Nervous System Disorders Convulsion, dizziness, headache, neuralgia, neuritis, speech disorder Psychiatric Disorders Agitation, confusional state, delirium, hallucination, illusion Renal and Urinary Disorders Oliguria, polyuria Respiratory, Thoracic and Mediastinal Disorders Apnea, bronchospasm, dyspnea, hypercapnia, hypoventilation, hypoxia, pulmonary congestion, respiratory acidosis Skin and Subcutaneous Tissue Disorders Hyperhidrosis Surgical and Medical Procedures Light anesthesia Vascular Disorders Blood pressure fluctuation, hemorrhage, hypertension, hypotension

2.

Food and Drug Administration (DailyMed).

Publish date: October 5, 2023.

Adverse Reactions The most frequently observed treatment-emergent adverse events included hypotension, hypertension, nausea, bradycardia, fever, vomiting, hypoxia, tachycardia and anemia (see Table 4 ). Table 4: Treatment-Emergent Adverse Events Occurring in >1% of All Dexmedetomidine-Treated Adult Patients in the Randomized Placebo-Controlled Continuous Infusion <24 Hours ICU Sedation Studies Adverse Event Randomized Dexmedetomidine (N = 387) Placebo (N = 379) Hypotension 28% 13% Hypertension 16% 18% Nausea 11% 9% Bradycardia 7% 3% Fever 5% 4% Vomiting 4% 6% Atrial Fibrillation 4% 3% Hypoxia 4% 4% Tachycardia 3% 5% Hemorrhage 3% 4% Anemia 3% 2% Dry Mouth 3% 1% Rigors 2% 3% Agitation 2% 3% Hyperpyrexia 2% 3% Pain 2% 2% Hyperglycemia 2% 2% Acidosis 2% 2% Pleural Effusion 2% 1% Oliguria 2% <1% Thirst 2% <1% In a controlled clinical trial, dexmedetomidine was compared to midazolam for ICU sedation exceeding 24 hours duration in adult patients. Key treatment emergent adverse events occurring in dexmedetomidine or midazolam treated adult patients in the randomized active comparator continuous infusion long-term intensive care unit sedation study are provided in Table 5. The number (%) of adult subjects who had a dose-related increase in treatment-emergent adverse events by maintenance adjusted dose rate range in the dexmedetomidine group is provided in Table 6. Table 5: Key Treatment-Emergent Adverse Events Occurring in Dexmedetomidine- or Midazolam-Treated Adult Patients in the Randomized Active Comparator Continuous Infusion Long-Term Intensive Care Unit Sedation Study † Includes any type of hypertension.

3.

Food and Drug Administration (DailyMed).

Publish date: May 5, 2024.

Adverse Reactions 6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: • Hypotension, bradycardia and sinus arrest [see Warnings and Precautions (5.2) ] • Transient hypertension [see Warnings and Precautions (5.3) ] • The most common adverse reactions (incidence >2%) in adults are hypotension, bradycardia, and dry mouth. ( 6.1 ) • The most common adverse reactions (incidence >5%) in pediatric patients aged 1 month to less than 17 years are bradypnea, bradycardia, hypertension, and hypotension. ( 6.1 ) • Adverse reactions in adults, associated with infusions >24 hours in duration include ARDS, respiratory failure, and agitation. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Hospira, Inc. at 1-800-441-4100, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reactions rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Most common treatment-emergent adverse reactions, occurring in greater than 2% of adult patients in both Intensive Care Unit and procedural sedation studies include hypotension, bradycardia and dry mouth. Intensive Care Unit Sedation Adverse reaction information is derived from the continuous infusion trials of Precedex (dexmedetomidine hydrochloride) for sedation in the Intensive Care Unit setting in which 1,007 adult patients received Precedex (dexmedetomidine hydrochloride). The mean total dose was 7.4 mcg/kg (range: 0.8 to 84.1), mean dose per hour was 0.5 mcg/kg/hr (range: 0.1 to 6.0) and the mean duration of infusion of 15.9 hours (range: 0.2 to 157.2). The population was between 17 to 88 years of age, 43% ≥65 years of age, 77% male and 93% Caucasian.

4.

Elsevier ClinicalKey Drug Monograph

Content last updated: May 4, 2024.

Adverse Reactions 1. agitation 2. bradycardia 3. constipation 4. drowsiness 5. hypertension 6. hypotension 7. nausea 8. respiratory depression 9. sinus tachycardia 10. abdominal pain 11. acute respiratory distress syndrome (ARDS) 12. anemia 13. anxiety 14. atrial fibrillation 15. bleeding 16. chills 17. dizziness 18. dyspepsia 19. edema 20. fever 21. gastroesophageal reflux 22. hyperglycemia 23. hyperthermia 24. hypoesthesia 25. hypoglycemia 26. hypokalemia 27. hypovolemia 28. hypoxia 29. metabolic acidosis 30. oliguria 31. orthostatic hypotension 32. paresthesias 33. pleural effusion 34. polydipsia 35. renal failure (unspecified) 36. vomiting 37. withdrawal 38. xerostomia 39. hypocalcemia 40. hypomagnesemia 41. peripheral edema 42. pulmonary edema 43. ventricular tachycardia 44. wheezing 45. adrenocortical insufficiency 46. apnea 47. arrhythmia exacerbation 48. AV block 49. bronchospasm 50. cardiac arrest 51. confusion 52. delirium 53. diarrhea 54. dysarthria 55. dyspnea 56. elevated hepatic enzymes 57. hallucinations 58. headache 59. hyperbilirubinemia 60. hyperhidrosis 61. hyperkalemia 62. hypernatremia 63. hypoventilation 64. myocardial infarction 65. neuritis 66. palpitations 67. photopsia 68. physiological dependence 69. polyuria 70. pruritus 71. QT prolongation 72. rash 73. seizures 74. supraventricular tachycardia (SVT) 75. tolerance 76. urticaria 77. visual impairment

Adverse Reactions Dexmedetomidine commonly causes sedation, which is an expected pharmacologic effect with IV use. Agitation (2% to 7%) and anxiety have been reported during adult intensive care sedation trials of intravenous dexmedetomidine. These effects appear to be dose-related; average IV infusion rates less than 0.7 mcg/kg/hour were associated with agitation or anxiety in 5% of adult patients, while infusion rates more than 1.1 mcg/kg/hour IV were associated with agitation or anxiety in 14% and 9% of patients, respectively. Seizures, confusion, delirium, dizziness, hallucinations or illusions, headache, speech disorders (dysarthria or dysphasia, unspecified), neuralgia, neuritis, and light anesthesia have been reported during postmarketing use of IV dexmedetomidine. Patients may be arousable and alert when stimulated; this alone should not be considered as a lack of efficacy in the absence of other clinical signs and symptoms. For dexmedetomidine sublingual film, drowsiness (somnolence) was the most commonly reported adverse reaction in clinical trials, affecting 22% to 23% of treated patients and at incidences higher than with placebo (6%). Effects may linger after treatment, and clinicians should ensure adequate alertness prior to ambulation after receiving a dose. Patients should avoid driving or operating hazardous machinery for at least 8 hours after taking dexmedetomidine sublingual film. Dizziness was also noted with sublingual/buccal use, affecting 4% to 6% of patients receiving dexmedetomidine compared to 1% on placebo.

Adverse Reactions Dexmedetomidine may induce fever (4% to 7%), hyperpyrexia (2%), or hyperthermia (2%), which may be resistant to traditional cooling methods, including cooled IV fluids and antipyretic medications. Discontinue dexmedetomidine if drug-related hyperthermia or fever is suspected and monitor the patient until the body temperature normalizes. Chills (2%), rigors (2%), hypovolemia (3%), generalized edema (2%), and pain (unspecified) (2%) have also been reported in adults during clinical trials of IV dexmedetomidine. Peripheral edema rarely occurred during these clinical trials and was dose-related, occurring in 3% of adults who received an average infusion rate of less than 0.7 mcg/kg/hour IV and 7% of adults who received an average rate of more than 1.1 mcg/kg/hour IV. Bleeding, including post-procedure bleeding, was noted in 2% to 3% of patients.

5.

Elsevier ClinicalKey Drug Class Overview

Content last updated: June 0, 2020.

Adverse Reactions / Side Effects Table Adverse Reactions / Side Effects | Dexmedetomidine Hydrochloride | Lorazepam | Midazolam Hydrochloride | Propofol ---|---|---|---|--- agitation | 2 - 14% | 0.1 - 1% | <4% | <1% anxiety | 5 - 9% | Reported | <1% | <1% apnea | Reported | >1% | 2.8 - 15.4% | 1 - 3% bradycardia | 3 - 62% | Reported | <1% | 1 - 3% drowsiness | 22 - 23% | 1.5 - 15.9% | 1.2 - 10% | <1% hypotension | 5 - 56% | 0.1 - 2.4% | <2.7% | 3 - 26% hypoxia | 2 - 8% | Reported | Reported | <1% nausea | 2 - 11% | <1% | 1.5 - 2.8% | <1% sinus tachycardia | 1 - 25% | Reported | <1% | <3% fever | 4 - 7% | | 4% | <1% hypertension | 8 - 38% | Reported | | <8% injection site reaction | | 0.5 - 17% | <5.6% | 10 - 17.6% paresthesias | 6 - 7% | | <1% | <1% respiratory depression | 37 - 67% | | 8 - 23.3% | Reported constipation | 6 - 14% | Reported | | hyperglycemia | 2 - 7% | | | <1% xerostomia | 3 - 7% | | | <1% acute respiratory distress syndrome (ARDS) | 2.5 - 9% | | | hypoesthesia | 6 - 7% | | | hypokalemia | 9% | | |