Note: This document contains side effect information about dexmedetomidine. Some dosage forms listed on this page may not apply to the brand name Precedex.

Summary

Common side effects of Precedex include: bradycardia, hypotension, agitation, hypertension, nausea, and tachycardia. Other side effects include: vomiting, and xerostomia. Continue reading for a comprehensive list of adverse effects.

Applies to dexmedetomidine: intravenous solution.

Serious side effects of Precedex

Along with its needed effects, dexmedetomidine (the active ingredient contained in Precedex) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur while taking dexmedetomidine:

More common

• Blurred vision
• chest pain or discomfort
• confusion
• coughing
• dizziness
• dizziness, faintness, or lightheadedness when getting suddenly up from a lying or sitting position
• headache
• irregular, fast or slow, or shallow breathing
• nervousness
• pale or blue lips, fingernails, or skin
• pounding in the ears
• slow or fast heartbeat
• sweating
• trouble breathing
• unusual tiredness or weakness

Less common

• Bleeding gums
• bloody urine
• coughing that sometimes produces a pink frothy sputum
• coughing up blood
• drowsiness
• dry mouth
• extremely high fever or body temperature
• fast, pounding, or irregular heartbeat or pulse
• fever
• flushed, dry skin
• fruit-like breath odor
• increased hunger
• increased menstrual flow or vaginal bleeding
• increased thirst
• increased urination
• loss of appetite
• lower back or side pain
• mood or mental changes
• muscle cramps in the hands, arms, feet, legs, or face
• muscle spasms or twitching seizures
• nausea
• nosebleeds
• numbness and tingling around the mouth, fingertips, or feet
• pale, clammy skin
• paralysis
• prolonged bleeding from cuts
• red or black, tarry stools
• red or dark brown urine
• seizures
• stomach cramps
• swelling of face, fingers, legs, or ankles
• tremor
• unexplained weight gain or loss
• vomiting

Incidence not known

• Chest tightness
• confusion as to time, place, or person
• frequent urination
• holding false beliefs that cannot be changed by fact
• increased volume of pale, dilute urine
• irritability
• no blood pressure
• pain or discomfort in the arms, jaw, back, or neck
• restlessness
• seeing, hearing, or feeling things that are not there
• shakiness
• sleepiness
• slow to respond
• slurred speech
• stomach pain
• stopping of the heart
• unconsciousness
• unusual excitement, nervousness, or restlessness
• weakness or heaviness of the legs
• yellow eyes or skin

Other side effects of Precedex

Some side effects of dexmedetomidine may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Anxiety
• constipation
• shaking

Incidence not known

• Hives, itching, rash
• redness of the skin
• seeing flashes or sparks of light

For Healthcare Professionals

Applies to dexmedetomidine: intravenous solution, sublingual film.

Cardiovascular

Very common (10% or more): Hypotension (56%), bradycardia (42%), systolic hypertension (28%), hypotension requiring intervention (28%), tachycardia (25%), hypertension requiring intervention (19%), hypertension (16%), diastolic hypertension (12%), tachycardia requiring intervention (10%)

Common (1% to 10%): Atrial fibrillation, sinus tachycardia, myocardial ischemia or infarction, bradycardia requiring intervention

Uncommon (0.1% to 1%): Ventricular tachycardia, atrioventricular block first degree, decreased cardiac output

Frequency not reported: Sinus arrest

Postmarketing reports: Arrhythmia, cardiac arrest, cardiac disorder, extrasystoles, supraventricular tachycardia, ventricular arrhythmia, electrocardiogram T wave inversion, prolonged QT, blood pressure fluctuation, heart block^[Ref]

Respiratory

Very common (10% or more): Respiratory depression (37%)

Common (1% to 10%): Atelectasis, hypoxia, pulmonary edema, pleural effusion, respiratory failure, acute respiratory distress syndrome, bradypnea, pneumonia, pharyngolaryngeal pain

Uncommon (0.1% to 1%): Wheezing, dyspnea, apnea

Frequency not reported: Decreased respiratory rate

Postmarketing reports: Bronchospasm, hypercapnia, hypoventilation, pulmonary congestion, respiratory acidosis^[Ref]

Gastrointestinal

Very common (10% or more): Nausea (11%)

Common (1% to 10%): Dry mouth, vomiting, constipation, abdominal distension, abdominal pain, diarrhea^[Ref]

Dermatologic

Common (1% to 10%): Decubitus ulcer

Uncommon (0.1% to 1%): Rash

Postmarketing reports: Hyperhidrosis^[Ref]

Hematologic

Common (1% to 10%): Anemia

Uncommon (0.1% to 1%): Thrombocytopenia^[Ref]

Metabolic

Common (1% to 10%): Hypovolemia, hyperglycemia, hypoglycemia, hypocalcemia, acidosis, hypokalemia, hypomagnesemia, hypernatremia, hypophosphatemia

Uncommon (0.1% to 1%): Metabolic acidosis, hypoalbuminemia, electrolyte imbalance

Postmarketing reports: Hyperkalemia, acidosis^[Ref]

Nervous system

Common (1% to 10%): Headache

Postmarketing reports: Convulsion, dizziness, neuralgia, neuritis, speech disorder^[Ref]

Other

Common (1% to 10%): Pyrexia, hyperthermia, chills, post-procedural hemorrhage, withdrawal event/syndrome, rigors, hyperpyrexia, pain, thirst, generalized edema, peripheral edema, sepsis, septic shock

Uncommon (0.1% to 1%): Ineffective drug

Frequency not reported: Tolerance, tachyphylaxis

Postmarketing reports: Light anesthesia^[Ref]

Psychiatric

Common (1% to 10%): Agitation, anxiety

Uncommon (0.1% to 1%): Hallucination

Postmarketing reports: Confusional state, delirium, illusion^[Ref]

Renal

Common (1% to 10%): Acute renal failure, decreased urine output, oliguria

Postmarketing reports: Increased blood urea, polyuria^[Ref]

Hepatic

Postmarketing reports: Abnormal hepatic function, hyperbilirubinemia, increased ALT, increased AST, increased blood alkaline phosphatase, increased gamma-glutamyl transferase^[Ref]

Ocular

Frequency not reported: Reduced lacrimation

Postmarketing reports: Photopsia, abnormal vision, visual impairment^[Ref]