Ultiva

Last reviewed on RxList: 10/28/2019
Ultiva Side Effects Center

Last reviewed on RxList 10/28/2019

What Is Ultiva?

Ultiva (remifentanil) is a narcotic (opioid) pain medicine used to treat or prevent acute pain after surgery.

What Are Side Effects of Ultiva?

Common side effects of Ultiva include:

Tell your doctor if you have serious side effects of Ultiva, which may clear up within minutes after stopping the infusion or decreasing the dose:

  • weak, shallow breathing, or breathing that stops;
  • fast or slow heart rate;
  • stiff muscles;
  • severe weakness, or
  • feeling light-headed or fainting.

Dosage for Ultiva

Ultiva is for intravenous (IV) use only and is administered under a physician's supervision. Dose is determined by weight of the patient. Your breathing and other vital signs will be constantly monitored while you are treated with this drug.

What Drugs, Substances, or Supplements Interact with Ultiva?

Ultiva may interact with:

  • MAO inhibitors,
  • drugs for sleep,
  • sedatives,
  • tranquilizers,
  • anti-anxiety drugs,
  • narcotic pain relievers,
  • psychiatric medicines,
  • anti-seizure drugs,
  • muscle relaxants, or
  • antihistamines

Check the labels on all medicines (e.g., cough-and-cold products) because they may contain drowsiness-causing ingredients. Tell your doctor all medications you are taking.

Ultiva During Pregnancy and Breastfeeding

Ultiva should be used during pregnancy only if prescribed. It is not known whether this medication passes in breast milk. Consult your doctor before breastfeeding.

Additional Information

Our Ultiva (remifentanil) 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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Ultiva Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Like other opioid medicines, remifentanil can slow your breathing. Death may occur if breathing becomes too weak.

Your caregivers will watch for any side effects you have, such as:

  • noisy breathing, sighing, shallow breathing, breathing that stops during sleep;
  • fast or slow heart rate;
  • stiff muscles; or
  • severe weakness, feeling light-headed or fainting.

Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea.

Serious side effects may be more likely in older adults and those who are overweight, malnourished, or debilitated.

Common side effects may include:

  • slow breathing;
  • slow heart rate;
  • muscle stiffness; or
  • feeling light-headed.

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 Ultiva (Remifentanil)

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Ultiva Professional Information

SIDE EFFECTS

The following serious adverse reactions are described, or described in greater detail, in other sections:

  • Addiction, Abuse, and Misuse [see WARNINGS AND PRECAUTIONS]
  • Respiratory Depression in Spontaneously Breathing Patients [see WARNINGS AND PRECAUTIONS]
  • Interactions with Benzodiazepines or other CNS Depressants [see WARNINGS AND PRECAUTIONS]
  • Serotonin Syndrome [see WARNINGS AND PRECAUTIONS]
  • Skeletal Muscle Rigidity [see WARNINGS AND PRECAUTIONS]
  • Bradycardia [see WARNINGS AND PRECAUTIONS]
  • Hypotension [see WARNINGS AND PRECAUTIONS]
  • Biliary Tract Disease [see WARNINGS AND PRECAUTIONS]
  • Seizures [see WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction 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.

Adverse event information is derived from controlled clinical studies that were conducted in a variety of surgical procedures of varying duration, using a variety of premedications and other anesthetics, and in patient populations with diverse characteristics including underlying disease.

Adults

Approximately 2,770 adult patients were exposed to ULTIVA in controlled clinical studies. The frequencies of adverse events during general anesthesia with the recommended doses of ULTIVA are given in Table 11. Each patient was counted once for each type of adverse event.

Table 11: Adverse Events Reported in ≥ 1% of Adult Patients in General Anesthesia Studiesa at the Recommended Dosesb of ULTIVA

Adverse Event Induction/Maintenance Postoperative Analgesia After Discontinuation
ULTIVA
(n = 921)
Alfentanil/ Fentanyl
(n = 466)
ULTIVA
(n = 281)
Morphine
(n = 98)
ULTIVA
(n = 929)
Alfentanil/ Fentanyl
(n = 466)
Nausea 8 (< 1%) 0 61 (22%) 15 (15%) 339 (36%) 202 (43%)
Hypotension 178 (19%) 30 (6%) 0 0 16 (2%) 9 (2%)
Vomiting 4 (< 1%) 1 (< 1%) 22 (8%) 5 (5%) 150 (16%) 91 (20%)
Muscle rigidity 98 (11%)c 37 (8%) 7 (2%) 0 2 (< 1%) 1 (< 1%)
Bradycardia 62 (7%) 24 (5%) 3 (1%) 3 (3%) 11 (1%) 6 (1%)
Shivering 3 (< 1%) 0 15 (5%) 9 (9%) 49 (5%) 10 (2%)
Fever 1 (< 1%) 0 2 (< 1%) 0 44 (5%) 9 (2%)
Dizziness 0 0 1 (< 1%) 0 27 (3%) 9 (2%)
Visual disturbance 0 0 0 0 24 (3%) 14 (3%)
Headache 0 0 1 (< 1%) 1 (1%) 21 (2%) 8 (2%)
Respiratory depression 1 (< 1%) 0 19 (7%) 4 (4%) 17 (2%) 20 (4%)
Apnea 0 1 (< 1%) 9 (3%) 2 (2%) 2 (< 1%) 1 (< 1%)
Pruritus 2 (< 1%) 0 7 (2%) 1 (1%) 22 (2%) 7 (2%)
Tachycardia 6 (< 1%) 7 (2%) 0 0 10 (1%) 8 (2%)
Postoperative pain 0 0 7 (2%) 0 4 (< 1%) 5 (1%)
Hypertension 10 (1%) 7 (2%) 5 (2%) 3 (3%) 12 (1%) 8 (2%)
Agitation 2 (< 1%) 0 3 (1%) 1 (1%) 6 (< 1%) 1 (< 1%)
Hypoxia 0 0 1 (< 1%) 0 10 (1%) 7 (2%)
a Does not include adverse events from cardiac studies or the neonatal study. See Tables 14, 15, and 16 for cardiac information.
b See Table 1 for recommended doses. Not all doses of ULTIVA were equipotent to the comparator opioid. Administration of ULTIVA in excess of the recommended dose (i.e., doses > 1 and up to 20 mcg/kg) resulted in a higher incidence of some adverse events: muscle rigidity (37%), bradycardia (12%), hypertension (4%), and tachycardia (4%).
c Included in the muscle rigidity incidence is chest wall rigidity (5%). The overall muscle rigidity incidence is < 1% when remifentanil is administered concurrently or after a hypnotic induction agent.

In the elderly population (> 65 years), the incidence of hypotension is higher, whereas the incidence of nausea and vomiting is lower.

Table 12: Incidence (%) of Most Common Adverse Events by Gender in General Anesthesia Studiesa at the Recommended Dosesb of ULTIVA

Adverse Event n Induction Maintenance Postoperative Analgesia After Discontinuation
ULTIVA Alfentanil/F entanyl ULTIVA Morphine ULTIVA Alfentanil/F entanyl
Male 326 Female 595 Male 183 Female 283 Male 85 Female 196 Male 36 Female 62 Male 332 Female 597 Male 183 Female 283
Nausea 2% < 1% 0 0 12% 26% 8% 19% 22% 45% 30% 52%
Hypotension 29% 14% 7% 6% 0 0 0 0 2% 2% 2% 2%
Vomiting < 1% < 1% 0 < 1% 4% 10% 0 8% 5% 22% 8% 27%
Muscle rigidity 17% 7% 14% 4% 6% 1% 0 0 < 1% < 1% 0 < 1%
a Does not include adverse events from cardiac studies or the neonatal study.
b See Table 1 for recommended doses. Not all doses of ULTIVA were equipotent to the comparator opioid.

The frequencies of adverse events from the clinical studies at the recommended doses of ULTIVA in monitored anesthesia care are given in Table 13.

Table 13: Adverse Events Reported in ≥ 1% of Adult Patients in Monitored Anesthesia Care Studies at the Recommended Dosesa of ULTIVA

Adverse Event ULTIVA
(n = 159)
ULTIVA + 2 mg Midazolamb
(n = 103)
Propofol (0.5 mg/kg then 50 mcg/kg/min)
(n = 63)
Nausea 70 (44%) 19 (18%) 20 (32%)
Vomiting 35 (22%) 5 (5%) 13 (21%)
Pruritus 28 (18%) 16 (16%) 0
Headache 28 (18%) 12 (12%) 6 (10%)
Sweating 10 (6%) 0 1 (2%)
Shivering 8 (5%) 1 (< 1%) 1 (2%)
Dizziness 8 (5%) 5 (5%) 1 (2%)
Hypotension 7 (4%) 0 6 (10%)
Bradycardia 6 (4%) 0 7 (11%)
Respiratory depression 4 (3%) 1 (< 1%)a 0
Muscle rigidity 4 (3%) 0 1 (2%)
Chills 2 (1%) 0 2 (3%)
Flushing 2 (1%) 0 0
Warm sensation 2 (1%) 0 0
Pain at study IV site 2 (1%) 0 11 (17%)
a See Table 3 for recommended doses. Administration of ULTIVA in excess of the recommended infusion rate (i.e., starting doses > 0.1 mcg/kg/min) resulted in a higher incidence of some adverse events: nausea (60%), apnea (8%), and muscle rigidity (5%).
b With higher midazolam doses, higher incidences of respiratory depression and apnea were observed.

Other Adverse Events In Adult Patients

The frequencies of less commonly reported adverse clinical events from all controlled general anesthesia and monitored anesthesia care studies are presented below.

Event frequencies are calculated as the number of patients who were administered ULTIVA and reported an event divided by the total number of patients exposed to ULTIVA in all controlled studies including cardiac dose-ranging and neurosurgery studies (n = 1,883 general anesthesia, n = 609 monitored anesthesia care).

Incidence Less than 1%

Digestive: constipation, abdominal discomfort, xerostomia, gastro-esophageal reflux, dysphagia, diarrhea, ileus.

Cardiovascular: various atrial and ventricular arrhythmias, heart block, ECG change consistent with myocardial ischemia, elevated CPK-MB level, syncope.

Musculoskeletal: muscle stiffness, musculoskeletal chest pain.

Respiratory: cough, dyspnea, bronchospasm, laryngospasm, rhonchi, stridor, nasal congestion, pharyngitis, pleural effusion, hiccup(s), pulmonary edema, rales, bronchitis, rhinorrhea.

Nervous: anxiety, involuntary movement, prolonged emergence from anesthesia, confusion, awareness under anesthesia without pain, rapid awakening from anesthesia, tremors, disorientation, dysphoria, nightmare(s), hallucinations, paresthesia, nystagmus, twitch, seizure, amnesia.

Body as a Whole: decreased body temperature, anaphylactic reaction, delayed recovery from neuromuscular block.

Skin: rash, urticaria.

Urogenital: urine retention, oliguria, dysuria, urine incontinence.

Infusion Site Reaction: erythema, pruritus, rash.

Metabolic and Nutrition: abnormal liver function, hyperglycemia, electrolyte disorders, increased CPK level.

Hematologic and Lymphatic: anemia, lymphopenia, leukocytosis, thrombocytopenia.

The frequencies of adverse events from the clinical studies at the recommended doses of ULTIVA in cardiac surgery are given in Tables 14, 15, and 16. These tables represent adverse events collected during discrete phases of cardiac surgery. Any event should be viewed as temporally associated with drug administration and the phase indicated should not be perceived as the only time the event might occur.

Table 14: Adverse Events Reported in ≥ 1% of Patients in the Induction/Intubation and Maintenance Phases of Cardiac Surgery Studies at the Recommended Dosesa of ULTIVA

Adverse Event Induction/Intubation Maintenance
ULTIVA
(n = 227)
Fentanyl
(n = 176)
Sufentanil
(n = 41)
ULTIVA
(n = 227)
Fentanyl
(n = 176)
Sufentanil
(n = 41)
Hypotension 18 (8%) 6 (3%) 7 (17%) 26 (11%) 6 (3%) 1 (2%)
Bradycardia 9 (4%) 5 (3%) 0 3 (1%) 1 (< 1%) 1 (2%)
Hypertension 3 (1%) 2 (1%) 2 (5%) 8 (4%) 6 (3%) 1 (2%)
Constipation 9 (4%) 1 (< 1%) 3 (7%) 0 0 1 (2%)
Muscle rigidity 2 (< 1%) 2 (1%) 0 5 (2%) 8 (5%) 0
Premature ventricular beats 1 (< 1%) 0 0 3 (1%) 1 (< 1%) 0
Myocardial ischemia 0 0 0 7 (3%) 8 (5%) 1 (2%)
Atrial fibrillation 0 0 0 7 (3%) 3 (2%) 1 (2%)
Decreased cardiac output 0 0 0 5 (2%) 1 (< 1%) 1 (2%)
Tachycardia 0 1 (< 1%) 0 4 (2%) 2 (1%) 0
Coagulation disorder 0 0 0 4 (2%) 0 1 (2%)
Arrhythmia 0 0 0 3 (1%) 0 0
Ventricular fibrillation 0 0 0 3 (1%) 1 (< 1%) 1 (2%)
Postoperative complication 0 0 0 3 (1%) 0 0
Third degree heart block 0 0 0 2 (< 1%) 0 1 (2%)
Hemorrhage 0 0 0 2 (< 1%) 0 1 (2%)
Perioperative complication 0 0 0 2 (< 1%) 1 (< 1%) 1 (2%)
Involuntary movement(s) 0 0 0 2 (< 1%) 3 (2%) 0
Thrombocytop enia 0 0 1 (2%) 0 0 0
Oliguria 0 0 0 0 3 (2%) 0
Anemia 0 0 0 2 (< 1%) 2 (1%) 0
a See Table 4 for recommended doses.

Table 15: Adverse Events Reported in ≥ 1% of Patients in the ICU Phase of Cardiac Surgery Studies at the Recommended Dosesa of ULTIVA

Adverse Event ULTIVA
n = 227
Fentanyl
n = 176
Sufentanil
n = 41
Hypertension 14 (6%) 8 (5%) 2 (5%)
Hypotension 12 (5%) 3 (2%) 1 (2%)
Tachycardia 9 (4%) 5 (3%) 0
Shivering 8 (4%) 3 (2%) 1 (2%)
Nausea 8 (4%) 3 (2%) 0
Hemorrhage 4 (2%) 1 (< 1%) 1 (2%)
Postoperative complication 4 (2%) 5 (3%) 2 (5%)
Agitation 4 (2%) 1 (< 1%) 1 (2%)
Ache 4 (2%) 0 0
Decreased cardiac output 3 (1%) 0 0
Arrhythmia 3 (1%) 0 0
Muscle rigidity 2 (< 1%) 1 (< 1%) 2 (5%)
Bradycardia 2 (< 1%) 2 (1%) 0
Vomiting 1 (< 1%) 2 (1%) 0
Premature ventricular beats 1 (< 1%) 2 (1%) 0
Anemia 0 3 (2%) 0
Somnolence 0 0 1 (2%)
Fever 0 2 (1%) 0
a See Table 4 for recommended doses.

Table 16: Adverse Events Reported in ≥ 1% of Patients in the Post-Study Drug Phase of Cardiac Surgery Studies at the Recommended Dosesa of ULTIVA

Adverse Event ULTIVA
n = 227
Fentanyl
n = 176

Sufentanil
n = 41

Nausea 90 (40%) 63 (36%) 16 (39%)
Vomiting 33 (15%) 26 (15%) 3 (7%)
Fever 30 (13%) 15 (9%) 0
Atrial fibrillation 27 (12%) 33 (19%) 4 (10%)
Constipation 20 (9%) 35 (20%) 3 (7%)
Pleural effusion 11 (5%) 2 (1%) 2 (5%)
Hypotension 8 (4%) 8 (5%) 1 (2%)
Tachycardia 9 (4%) 15 (9%) 0
Postoperative complication 10 (4%) 6 (3%) 2 (5%)
Oliguria 7 (3%) 7 (4%) 1 (2%)
Confusion 7 (3%) 10 (6%) 5 (12%)
Ache 6 (3%) 2 (1%) 0
Anxiety 6 (3%) 6 (3%) 0
Headache 6 (3%) 2 (1%) 0
Perioperative complication 5 (2%) 7 (4%) 1 (2%)
Anemia 5 (2%) 5 (3%) 1 (2%)
Agitation 5 (2%) 3 (2%) 1 (2%)
Diarrhea 5 (2%) 1 (< 1%) 1 (2%)
Edema 4 (2%) 6 (3%) 0
Dizziness 4 (2%) 3 (2%) 1 (2%)
Postoperative infection 5 (2%) 7 (4%) 0
Hypoxia 4 (2%) 5 (3%) 0
Apnea 4 (2%) 1 (< 1%) 1 (2%)
Hypertension 3 (1%) 3 (2%) 0
Shivering 3 (1%) 1 (< 1%) 0
Heartburn 3 (1%) 3 (2%) 0
Atrial flutter 3 (1%) 1 (< 1%) 0
Arrhythmia 3 (1%) 5 (3%) 0
Hallucinations 3 (1%) 3 (2%) 0
Pneumonia 3 (1%) 3 (2%) 1 (2%)
Pharyngitis 3 (1%) 1 (< 1%) 1 (2%)
Decreased mental acuity 3 (1%) 1 (< 1%) 0
Dyspnea 3 (1%) 1 (< 1%) 0
Cough 3 (1%) 0 0
Decreased cardiac output 1 (< 1%) 0 3 (7%)
Renal insufficiency 1 (< 1%) 5 (3%) 0
Bradycardia 1 (< 1%) 1 (< 1%) 1 (2%)
Urine retention 2 (< 1%) 3 (2%) 0
Cerebral infarction 2 (< 1%) 2 (1%) 1 (2%)
Premature ventricular beats 2 (< 1%) 3 (2%) 0
Cerebral ischemia 1 (< 1%) 1 (< 1%) 1 (2%)
Paresthesia 2 (< 1%) 2 (1%) 0
Seizure 2 (< 1%) 1 (< 1%) 1 (2%)
Sleep disorder 1 (< 1%) 1 (< 1%) 1 (2%)
Bronchospasm 1 (< 1%) 6 (3%) 0
Atelectasis 2 (< 1%) 3 (2%) 0
Respiratory depression 2 (< 1%) 3 (2%) 0
Pulmonary edema 1 (< 1%) 2 (1%) 0
Respiratory distress 2 (< 1%) 0 1 (2%)
Hyperkalemia 2 (< 1%) 3 (2%) 0
Electrolyte disorder 0 3 (2%) 0
Chest congestion 0 3 (2%) 0
Hemoptysis 0 2 (1%) 0
Facial ptosis 0 2 (1%) 0
Hemorrhage 0 2 (1%) 0
Hematuria 0 1 (< 1%) 1 (2%)
Visual disturbance(s) 0 1 (< 1%) 1 (2%)
Hypokalemia 0 2 (1%) 0
Exacerbation of renal failure 0 0 1 (2%)
Blood in stool 0 0 1 (2%)
First degree heart block 0 0 1 (2%)
Pericarditis 0 0 1 (2%)
a See Table 4 for recommended doses.

Pediatrics

ULTIVA has been studied in 342 pediatric patients in controlled clinical studies for maintenance of general anesthesia. In the pediatric population (birth to 12 years), the most commonly reported events were nausea, vomiting, and shivering.

The frequencies of adverse events during general anesthesia with the recommended doses of ULTIVA are given in Table 17. Each patient was counted once for each type of adverse event.

There were no adverse events ≥ 1% for any treatment group during the maintenance period in the pediatric patient general anesthesia studies.

Table 17: Adverse Events Reported in ≥ 1% of Pediatric Patients Receiving ULTIVA in General Anesthesia Studies at the Recommended Dosesa of ULTIVA

Adverse Event Recovery Follow-upb
ULTIVA
(n = 342)
Fentanyl
(n = 103)
Bupivacaine
(n = 86)
ULTIVA
(n = 342)
Fentanyl
(n = 103)
Bupivacaine
(n = 86)
Vomiting 40 (12%) 9 (9%) 10 (12%) 56 (16%) 8 (8%) 12 (14%)
Nausea 23 (8%) 7 (7%) 1 (1%) 17 (6%) 6 (6%) 5 (6%)
Shivering 9 (3%) 0 0 0 0 0
Rhonchi 8 (3%) 2 (2%) 0 0 0 0
Postoperative complication 5 (2%) 2 (2%) 0 4 (1%) 0 0
Stridor 4 (1%) 2 (2%) 0 0 0 0
Cough 4 (1%) 1 (< 1%) 0 0 0

0

a See Table 2 for recommended doses.
b In subjects receiving halothane (n = 22), 10 (45%) experienced vomiting.

Postmarketing Experience

The following adverse reactions have been identified during post approval use of remifentanil. 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.

Cardiovascular: Asystole

Serotonin syndrome: Cases of serotonin syndrome, a potentially life-threatening condition, have been reported during concomitant use of opioids with serotonergic drugs.

Anaphylaxis: Anaphylaxis has been reported with ingredients contained in ULTIVA.

Read the entire FDA prescribing information for Ultiva (Remifentanil)

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

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