Precedex Side Effects Center

Last updated on RxList: 3/23/2021
Precedex Side Effects Center

What Is Precedex?

Precedex (dexmedetomidine hydrochloride) is an alpha2-adrenergic agonist with sedative properties used for short-term intravenous sedation.

What Are Side Effects of Precedex?

Common side effects of Precedex include:

Dosage for Precedex

Precedex is only used in controlled settings and is administered intravenously (IV). Dosing of Precedex is individualized and adjusted to desired clinical response. It is not indicated for infusions lasting longer than 24 hours.

What Drugs, Substances, or Supplements Interact with Precedex?

Precedex may interact with anesthetics, sedatives, hypnotics, or opioids. Tell your doctor all prescription and over-the-counter medications you use.

Precedex During Pregnancy and Breastfeeding

During pregnancy, Precedex should only be used if prescribed. It is not known whether this medication passes into breast milk. Consult your doctor before breastfeeding. Precedex may produce withdrawal symptoms if abruptly discontinued.

Additional Information

Our Precedex (dexmedetomidine hydrochloride) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

QUESTION

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Precedex Consumer Information

Get emergency medical help if the patient has signs of an allergic reaction: hives; difficult breathing; swelling of the face, lips, tongue, or throat.

Tell the medical caregivers right away if the person receiving dexmedetomidine has:

  • agitation, signs of waking up, or any change in level of consciousness;
  • slow heartbeats;
  • weak or shallow breathing, cough;
  • feeling light-headed or short of breath;
  • muscle weakness; or
  • pale or blue-colored skin.

Certain side effects may occur during the first 48 hours after the patient stops receiving dexmedetomidine. Call the doctor right away if the patient has any of the following side effects:

  • headache, confusion, anxiety, feeling nervous or agitated;
  • weakness, feeling light-headed or short of breath;
  • stomach pain, diarrhea, constipation;
  • excessive sweating;
  • weight loss;
  • blurred vision, pounding in the neck or ears;
  • severe chest pain, rapid or irregular heartbeats; or
  • an unusual craving for salt.

Common side effects may include:

  • slowed breathing;
  • slow or irregular heartbeats;
  • anemia;
  • dry mouth, nausea;
  • fever; or
  • dizziness.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Precedex (Dexmedetomidine hydrochloride)

SLIDESHOW

Digestive Disorders: Common Misconceptions See Slideshow
Precedex Professional Information

SIDE EFFECTS

The following clinically significant adverse reactions are described elsewhere in the labeling:

  • Hypotension, bradycardia and sinus arrest [see WARNINGS AND PRECAUTIONS]
  • Transient hypertension [see WARNINGS AND PRECAUTIONS]

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 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 for sedation in the Intensive Care Unit setting in which 1,007 adult patients received Precedex. 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. Treatment-emergent adverse reactions occurring at an incidence of >2% are provided in Table 2. The most frequent adverse reactions were hypotension, bradycardia and dry mouth [see WARNINGS AND PRECAUTIONS].

Table 2: Adverse Reactions with an Incidence >2%-Adult Intensive Care Unit Sedation Population <24 hours*

Adverse EventAll Precedex
(N = 1007)
(%)
Randomized Precedex
(N = 798)
(%)
Placebo
(N = 400)
(%)
Propofol
(N = 188)
(%)
Hypotension25%24%12%13%
Hypertension12%13%19%4%
Nausea9%9%9%11%
Bradycardia5%5%3%0
Atrial Fibrillation4%5%3%7%
Pyrexia4%4%4%4%
Dry Mouth4%3%1%1%
Vomiting3%3%5%3%
Hypovolemia3%3%2%5%
Atelectasis3%3%3%6%
Pleural Effusion2%2%1%6%
Agitation2%2%3%1%
Tachycardia2%2%4%1%
Anemia2%2%2%2%
Hyperthermia2%2%3%0
Chills2%2%3%2%
Hyperglycemia2%2%2%3%
Hypoxia2%2%2%3%
Post-procedural Hemorrhage2%2%3%4%
Pulmonary Edema1%1%1%3%
Hypocalcemia1%1%02%
Acidosis1%1%1%2%
Urine Output Decreased1%1%02%
Sinus Tachycardia1%1%1%2%
Ventricular Tachycardia<1%1%1%5%
Wheezing<1%1%02%
Edema Peripheral<1%01%2%
* 26 subjects in the all Precedex group and 10 subjects in the randomized Precedex group had exposure for greater than 24 hours

Adverse reaction information was also derived from the placebo-controlled, continuous infusion trials of Precedex for sedation in the surgical intensive care unit setting in which 387 adult patients received Precedex for less than 24 hours. The most frequently observed treatment-emergent adverse events included hypotension, hypertension, nausea, bradycardia, fever, vomiting, hypoxia, tachycardia and anemia (see Table 3).

Table 3: 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 EventRandomized Dexmedetomidine
(N = 387)
Placebo
(N = 379)
Hypotension28%13%
Hypertension16%18%
Nausea11%9%
Bradycardia7%3%
Fever5%4%
Vomiting4%6%
Atrial Fibrillation4%3%
Hypoxia4%4%
Tachycardia3%5%
Hemorrhage3%4%
Anemia3%2%
Dry Mouth3%1%
Rigors2%3%
Agitation2%3%
Hyperpyrexia2%3%
Pain2%2%
Hyperglycemia2%2%
Acidosis2%2%
Pleural Effusion2%1%
Oliguria2%<1%
Thirst2%<1%

In a controlled clinical trial, Precedex 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 patients in the randomized active comparator continuous infusion long-term intensive care unit sedation study are provided in Table 4. The number (%) of subjects who had a dose-related increase in treatment-emergent adverse events by maintenance adjusted dose rate range in the Precedex group is provided in Table 5.

Table 4: 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

Adverse EventDexmedetomidine
(N = 244)
Midazolam
(N = 122)
Hypotension156%56%
Hypotension Requiring Intervention28%27%
Bradycardia242%19%
Bradycardia Requiring Intervention5%1%
Systolic Hypertension328%42%
Tachycardia425%44%
Tachycardia Requiring Intervention10%10%
Diastolic Hypertension312%15%
Hypertension311%15%
Hypertension Requiring Intervention19%30%
Hypokalemia9%13%
Pyrexia7%2%
Agitation7%6%
Hyperglycemia7%2%
Constipation6%6%
Hypoglycemia5%6%
Respiratory Failure5%3%
Renal Failure Acute2%1%
Acute Respiratory Distress Syndrome2%1%
Generalized Edema2%6%
Hypomagnesemia1%7%
Includes any type of hypertension
1 Hypotension was defined in absolute terms as Systolic blood pressure of <80 mmHg or Diastolic blood pressure of <50 mmHg or in relative terms as ≤30% lower than pre-study drug infusion value
2 Bradycardia was defined in absolute terms as <40 bpm or in relative terms as ≤30% lower than pre-study drug infusion value 3 Hypertension was defined in absolute terms as Systolic blood pressure >180 mmHg or Diastolic blood pressure of >100 mmHg or in relative terms as ≥30% higher than pre-study drug infusion value
4 Tachycardia was defined in absolute terms as >120 bpm or in relative terms as ≥30% greater than pre-study drug infusion value

The following adverse events occurred between 2 and 5% for Precedex and Midazolam, respectively: renal failure acute (2.5%, 0.8%), acute respiratory distress syndrome (2.5%, 0.8%), and respiratory failure (4.5%, 3.3%).

Table 5. Number (%) of Adult Subjects Who Had a Dose-Related Increase in Treatment Emergent Adverse Events by Maintenance Adjusted Dose Rate Range in the Precedex Group

Precedex (mcg/kg/hr)
Adverse Event≤0.7*
(N = 95)
>0.7 to ≤1.1*
(N = 78)
>1.1*
(N = 71)
Constipation6%5%14%
Agitation5%8%14%
Anxiety5%5%9%
Edema Peripheral3%5%7%
Atrial Fibrillation2%4%9%
Respiratory Failure2%6%10%
Acute Respiratory Distress Syndrome1%3%9%
* Average maintenance dose over the entire study drug administration

Procedural Sedation

Adverse reaction information is derived from the two trials for procedural sedation [see Clinical Studies] in which 318 adult patients received Precedex. The mean total dose was 1.6 mcg/kg (range: 0.5 to 6.7), mean dose per hour was 1.3 mcg/kg/hr (range: 0.3 to 6.1) and the mean duration of infusion of 1.5 hours (range: 0.1 to 6.2). The population was between 18 to 93 years of age, ASA I-IV, 30% ≥65 years of age, 52% male and 61% Caucasian.

Treatment-emergent adverse reactions occurring at an incidence of >2% are provided in Table 6. The most frequent adverse reactions were hypotension, bradycardia, and dry mouth [see WARNINGS AND PRECAUTIONS]. Pre-specified criteria for the vital signs to be reported as adverse reactions are footnoted below the table.

The decrease in respiratory rate and hypoxia was similar between Precedex and comparator groups in both studies.

Table 6: Adverse Reactions with an Incidence >2%—Procedural Sedation Population

Adverse EventPrecedex
(N = 318)
(%)
Placebo
(N = 113)
(%)
Hypotension154%30%
Respiratory Depression237%32%
Bradycardia314%4%
Hypertension413%24%
Tachycardia55%17%
Nausea3%2%
Dry Mouth3%1%
Hypoxia62%3%
Bradypnea2%4%
1 Hypotension was defined in absolute and relative terms as Systolic blood pressure of <80 mmHg or ≤30% lower than pre-study drug infusion value, or Diastolic blood pressure of <50 mmHg
2 Respiratory depression was defined in absolute and relative terms as respiratory rate (RR) <8 beats per minute or >25% decrease from baseline
3 Bradycardia was defined in absolute and relative terms as <40 beats per minute or ≤30% lower than pre-study drug infusion value
4 Hypertension was defined in absolute and relative terms as Systolic blood pressure >180 mmHg or ≥30% higher than pre-study drug infusion value or Diastolic blood pressure of >100 mmHg
5 Tachycardia was defined in absolute and relative terms as >120 beats per minute or ≥30% greater than pre-study drug infusion value
6 Hypoxia was defined in absolute and relative terms as SpO2 <90% or 10% decrease from baseline

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of Precedex. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Hypotension and bradycardia were the most common adverse reactions associated with the use of Precedex during post-approval use of the drug.

Table 7: Adverse Reactions Experienced During Post-Approval Use of Precedex

System Organ ClassPreferred Term
Blood and Lymphatic System DisordersAnemia
Cardiac DisordersArrhythmia, atrial fibrillation, atrioventricular block, bradycardia, cardiac arrest, cardiac disorder, extrasystoles, myocardial infarction, supraventricular tachycardia, tachycardia, ventricular arrhythmia, ventricular tachycardia
Eye DisordersPhotopsia, visual impairment
Gastrointestinal DisordersAbdominal pain, diarrhea, nausea, vomiting
General Disorders and Administration Site ConditionsChills, hyperpyrexia, pain, pyrexia, thirst
Hepatobiliary DisordersHepatic function abnormal, hyperbilirubinemia
InvestigationsAlanine aminotransferase increased, aspartate aminotransferase increased, blood alkaline phosphatase increased, blood urea increased, electrocardiogram T wave inversion, gammaglutamyltransferase increased, electrocardiogram QT prolonged
Metabolism and Nutrition DisordersAcidosis, hyperkalemia, hypoglycemia, hypovolemia, hypernatremia
Nervous System DisordersConvulsion, dizziness, headache, neuralgia, neuritis, speech disorder
Psychiatric DisordersAgitation, confusional state, delirium, hallucination, illusion
Renal and Urinary DisordersOliguria, polyuria
Respiratory, Thoracic and Mediastinal DisordersApnea, bronchospasm, dyspnea, hypercapnia, hypoventilation, hypoxia, pulmonary congestion, respiratory acidosis
Skin and Subcutaneous Tissue DisordersHyperhidrosis, pruritus, rash, urticaria
Surgical and Medical ProceduresLight anesthesia
Vascular DisordersBlood pressure fluctuation, hemorrhage, hypertension, hypotension

Read the entire FDA prescribing information for Precedex (Dexmedetomidine hydrochloride)

© Precedex Patient Information is supplied by Cerner Multum, Inc. and Precedex Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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