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

Summary

Common side effects of Ultiva include: nausea. Other side effects include: shivering and diaphoresis. Continue reading for a comprehensive list of adverse effects.

Applies to remifentanil: intravenous powder for solution, intravenous solution.

Serious side effects of Ultiva

Along with its needed effects, remifentanil (the active ingredient contained in Ultiva) 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 remifentanil:

More common

• Blurred vision
• chest pain or discomfort
• confusion
• difficult or troubled breathing
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• irregular, fast or slow, or shallow breathing
• lightheadedness, dizziness, or fainting
• muscle stiffness or tightness
• pale or blue lips, fingernails, or skin
• shortness of breath
• slow or irregular heartbeat
• sweating
• unusual tiredness or weakness

Less common

• Bluish lips or skin
• chills
• decrease in cardiac output
• fast, pounding, or heartbeat or pulse
• feeling of warmth
• fever
• headache
• nausea or vomiting
• nervousness
• not breathing
• pain after surgery
• pain in the shoulders, arms, jaw, or neck
• pounding in the ears
• problems with bleeding or clotting
• redness of the face, neck, arms, and occasionally, upper chest
• shivering

Rare

• Abdominal or stomach pain
• black, tarry stools
• bleeding gums
• blood in the urine or stools
• body aches or pain
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• congestion
• cough or hoarseness
• cough producing mucus
• coughing that sometimes produces a pink frothy sputum
• coughing up blood
• decreased frequency or amount of urine
• difficult, fast, or noisy breathing
• difficulty with swallowing
• disorientation
• dry mouth
• dryness or soreness of the throat
• dysphoria
• eye pain
• flushed, dry skin
• fruit-like breath odor
• general feeling of illness
• hiccups
• hives, itching, or skin rash
• increased blood pressure
• increased hunger
• increased menstrual flow or vaginal bleeding
• increased sweating
• increased thirst
• increased urination
• loss of appetite
• lower back or side pain
• muscle cramps or pain
• nervousness
• noisy breathing
• nosebleeds
• numbness or tingling in the hands, feet, or lips
• painful or difficult urination
• pale skin
• paralysis
• pinpoint red spots on the skin
• prolonged bleeding from cuts
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• rapid heartbeat
• red or black, tarry stools
• red or dark brown urine
• runny nose
• seizures
• shakiness in the legs, arms, hands, or feet
• small clicking, bubbling, or rattling sounds in the lungs when listening with a stethoscope
• stuffy nose
• swelling in the legs and ankles
• swelling of the face, fingers, or lower legs
• tender, swollen glands in the neck
• tightness in the chest
• troubled breathing with exertion
• unexplained weight loss
• unusual bleeding or bruising
• voice changes
• vomiting
• weakness and heaviness of the legs
• weight gain

Other side effects of Ultiva

Some side effects of remifentanil 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:

Less common

• Anxiety
• blurred or loss of vision
• difficulty having a bowel movement (stool)
• disturbed color perception
• double vision
• halos around lights
• hyperventilation
• night blindness
• overbright appearance of lights
• pain at the injection site
• restlessness
• trouble with sleeping
• tunnel vision

Rare

• Burning while urinating
• heartburn
• hives or welts
• loss of bladder control
• loss of memory
• nightmares
• problems with memory
• seeing, hearing, or feeling things that are not there
• severe constipation
• severe vomiting
• trouble with urinating
• uncontrolled eye movements

For Healthcare Professionals

Applies to remifentanil: intravenous powder for injection, intravenous solution.

General

The most commonly reported adverse reactions have included respiratory depression, bradycardia, hypotension, and skeletal muscle rigidity. In pediatric patients, the most commonly reported events were nausea, vomiting, and shivering.^[Ref]

Respiratory

Cough, dyspnea, bronchospasm, laryngospasm, rhonchi, stridor, nasal congestion, pharyngitis, pleural effusion, hiccups, pulmonary edema, rales, bronchitis, and rhinorrhea have been reported in less than 1% of patients.

Common (1% to 10%): Respiratory depression

Uncommon (0.1% to 1%): Apnea, hypoxia

Frequency not reported: Cough, dyspnea, bronchospasm, laryngospasm, rhonchi, stridor, nasal congestion, pharyngitis, pleural effusion, hiccups, pulmonary edema, rales, bronchitis, rhinorrhea

Opioids:

Frequency not reported: Serious respiratory depression

Cardiovascular

Very common (10% or more): Hypotension (up to 19%)

Common (1% to 10%): Bradycardia, atrial fibrillation, atrial flutter, myocardial ischemia, edema, flushing

Uncommon (0.1% to 1%): Decreased cardiac output

Rare (0.01% to 0.1%): Tachycardia, hypertension

Frequency not reported: Various atrial and ventricular arrhythmias, heart block, ECG change consistent with myocardial ischemia, elevated CPK-MB level, syncope, premature ventricular beats, atrioventricular block

Postmarketing reports: Asystole

Cardiovascular side effects such as hypotension and bradycardia have been reported to occur most frequently during the induction and maintenance period. Bradycardia and hypotension are probably due to a centrally mediated increase in vagal nerve activity. Glycopyrrolate, atropine and/or ephedrine may be useful in treating these effects. Unlike morphine, decreases in blood pressure are not due to histamine release.

In male patients and in those patient older 65 years, the incidence of hypotension is higher. Various atrial and ventricular arrhythmias, heart block, ECG change consistent with myocardial ischemia, elevated CPK-MB level, and syncope have been reported in less than 1% of patients.

Gastrointestinal

Very common (10% or more): Nausea (up to 44%), vomiting (up to 22%)

Common (1% to 10%): Constipation, heartburn

Frequency not reported: Abdominal discomfort, xerostomia, gastro-esophageal reflux, dysphagia, diarrhea, ileus

Musculoskeletal

Common (1% to 10%): Skeletal muscle rigidity

Frequency not reported: Muscle stiffness, musculoskeletal chest pain

Rigidity may be lessened by concomitant administration of a muscle relaxant. Muscle stiffness and musculoskeletal chest pain have been reported in less than 1% of patients.

Gastrointestinal

Nausea has been reported to occur in very commonly, especially when used as a postoperative analgesic and upon discontinuation. Abdominal discomfort, xerostomia, gastro-esophageal reflux, dysphagia, diarrhea, and ileus have been reported in less than 1% of patients.

Nervous system

Involuntary movement, prolonged emergence from anesthesia, awareness under anesthesia without pain, rapid awakening from anesthesia, tremors, paresthesia, nystagmus, twitch, and seizure have been reported in less than 1% of patients.

Common (1% to 10%): Dizziness, headache

Frequency not reported: Serotonin syndrome, involuntary movement, prolonged emergence from anesthesia, awareness under anesthesia without pain, rapid awakening from anesthesia, tremors, paresthesia, nystagmus, twitch, seizure

Hypersensitivity

Anaphylactic reaction was reported in less than 1% of patients.

Frequency not reported: Anaphylactic reaction

Psychiatric

Common (1% to 10%): Agitation

Frequency not reported: Anxiety, confusion, disorientation, dysphoria, nightmares, hallucinations, amnesia

Anxiety, confusion, disorientation, dysphoria, nightmares, hallucinations, amnesia have been reported in less than 1% of patients.

Local

Erythema, pruritus, and rash at the infusion site was reported in less than 1% of patients.

Common (1% to 10%): Pain at IV site

Frequency not reported: Erythema, pruritus, rash

Dermatologic

Common (1% to 10%): Pruritus, sweating

Rash and urticaria have been reported in less than 1% of patients.

Other

Common (1% to 10%): Shivering, fever, chills, sensation of warmth

Frequency not reported: Decreased body temperature

Hematologic

Common (1% to 10%): Coagulation disorder

Frequency not reported: Anemia, lymphopenia, leukocytosis, thrombocytopenia

Anemia, lymphopenia, leukocytosis, and thrombocytopenia have been reported in less than 1% of patients.

Ocular

Common (1% to 10%): Visual disturbances

Metabolic

Frequency not reported: Hyperglycemia, electrolyte disorders, increased CPK level

Genitourinary

Frequency not reported: Urine retention, oliguria, dysuria, urine incontinence

Urine retention, oliguria, dysuria, and urine incontinence have been reported in less than 1% of patients.

Hepatic

Frequency not reported: Abnormal liver function