Remifentanil

ULTIVA is a µ-opioid agonist with rapid onset and peak effect, and short duration of action. The µ-opioid activity of ULTIVA is antagonized by opioid antagonists such as naloxone.

• ULTIVA is indicated for intravenous (IV) administration: • As an analgesic agent for use during the induction and maintenance of general anesthesia for inpatient and outpatient procedures. • For continuation as an analgesic into the immediate postoperative period in adult patients under the direct supervision of an anesthesia practitioner in a postoperative anesthesia care unit or intensive care setting.

• ULTIVA is contraindicated: • For epidural or intrathecal administration due to the presence of glycine in the formulation [see Nonclinical Toxicology (13) ] . • In patients with hypersensitivity to remifentanil (e.g., anaphylaxis) [see Adverse Reactions (6.2) ] .contraindicated

• Monitor patients closely for respiratory depression when initiating therapy and following dosage increases and adjust the dosage accordingly. ( 2.1 ) • Initial Dosage in Adults : See full prescribing information for recommended doses in adult patients. ( 2.2 , 2.3 ) • Initial Dosage in Pediatric Patients : See full prescribing information for recommended doses in pediatric patients. ( 2.2 ) • Geriatric Patients : The starting doses should be decreased by 50% in elderly patients (> 65 years). ( 2.6 ) 2.1 Important Dosage and Administration Instructions Monitor patients closely for respiratory depression when initiating therapy and following dosage increases with ULTIVA and adjust the dosage accordingly [see Warnings and Precautions (5.2) ]. ULTIVA is for IV use only. Continuous infusions of ULTIVA should be administered only by an infusion device. The injection site should be close to the venous cannula and all IV tubing should be cleared at the time of discontinuation of infusion. ULTIVA should not be administered without dilution. Consider an alternative to ULTIVA for patients taking mixed agonist/antagonist and partial agonist opioid analgesics due to reduced analgesic effect or potential withdrawal symptoms. If concomitant use is warranted, carefully observe the patient, particularly during treatment initiation and dose adjustment. Discontinue ULTIVA if patient is not responding appropriately to treatment. Discard unused portion.

• Life-Threatening Respiratory Depression : Monitor closely, particularly during initiation and titration. ( 5.2 ) • Risks from Use as Postoperative Analgesia with Concomitant Benzodiazepines or other CNS Depressants : Hypotension, profound sedation, respiratory depression, coma, and death may result from the concomitant use of ULTIVA with benzodiazepines or other CNS depressants ( 5.3 ) • Opioid-Induced Hyperalgesia and Allodynia : Opioid-Induced Hyperalgesia (OIH) occurs when an opioid analgesic paradoxically causes an increase in pain, or an increase in sensitivity to pain. If OIH is suspected, carefully consider appropriately decreasing the dose of the current opioid analgesic or opioid rotation. ( 5.4 ) • Serotonin Syndrome : Potentially life-threatening condition could result from concomitant serotonergic drug administration. Discontinue ULTIVA if serotonin syndrome is suspected. ( 5.5 ) • Administration : Continuous infusions of ULTIVA should be administered only by an infusion device. ( 5.6 ) • Skeletal Muscle Rigidity: is related to the dose and speed of administration. Muscle rigidity induced by ULTIVA should be managed in the context of the patient's clinical condition. ( 5.7 ) • Potential Inactivation by Nonspecific Esterases in Blood Products : ULTIVA should not be administered into the same IV tubing with blood due to potential inactivation by nonspecific esterases in blood products. ( 5.8 ) • Bradycardia : Monitor heart rate during dosage initiation and titration.

The following serious adverse reactions are described, or described in greater detail, in other sections: • Addiction, Abuse, and Misuse [see Warnings and Precautions (5.1) ] • Life-Threatening Respiratory Depression [see Warnings and Precautions (5.2) ] • Interactions with Benzodiazepines or other CNS Depressants [see Warnings and Precautions (5.3) ] • Opioid-Induced Hyperalgesia and Allodynia [see Warnings and Precautions (5.4) ] • Serotonin Syndrome [see Warnings and Precautions (5.5) ] • Skeletal Muscle Rigidity [see Warnings and Precautions (5.7) ] • Bradycardia [see Warnings and Precautions (5.9) ] • Hypotension [see Warnings and Precautions (5.10) ] • Biliary Tract Disease [see Warnings and Precautions (5.13) ] • Seizures [see Warnings and Precautions (5.14) ] Most common adverse reactions (incidence ≥ 1%) were respiratory depression, bradycardia, hypotension, and skeletal muscle rigidity. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Mylan at 1-877-446-3679 (1-877-4-INFO-RX) 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 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.

• Pregnancy : May cause fetal harm. ( 8.1 ) • Labor or Delivery : Respiratory depression and other opioid effects may occur in newborns whose mothers are given ULTIVA shortly before delivery. ( 8.1 ) • Lactation : Infants exposed to ULTIVA through breast milk should be monitored for excess sedation and respiratory depression. ( 8.2 ) • Pediatric Use : ULTIVA has not been studied in pediatric patients for use as a postoperative analgesic or as an analgesic component of monitored anesthesia care. ( 8.4 ) 8.1 Pregnancy Risk Summary Use of opioid analgesics for an extended period of time during pregnancy may cause neonatal opioid withdrawal syndrome. Available data with remifentanil hydrochloride in pregnant women are insufficient to inform a drug-associated risk for major birth defects and miscarriage. In animal reproduction studies, reduced fetal rat body weight and pup weights were reported at 2.2 times a human intravenous infusion of an induction dose of 1 mcg/kg with a maintenance dose of 2 mcg/kg/min for a surgical procedure lasting 3 hours.

Metabolism

After IV doses administered over 60 seconds, the pharmacokinetics of remifentanil fit a three-compartment model with a rapid distribution half-life of one minute, a slower distribution half-life of 6 minutes, and a terminal elimination half-life of 10 to 20 minutes. Since the terminal elimination component contributes less than 10% of the overall area under the concentration versus time curve (AUC), the effective biological half-life of ULTIVA is 3 to 10 minutes.

Clinical Presentation Acute overdose with remifentanil can be manifested by respiratory depression, somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, constricted pupils, and, in some cases, pulmonary edema, bradycardia, hypotension, hypoglycemia, partial or complete airway obstruction, atypical snoring, and death. Marked mydriasis rather than miosis may be seen with hypoxia in overdose situations [see Clinical Pharmacology (12.2) ] . Treatment of Overdose In case of overdose, priorities are the reestablishment of a patent and protected airway and institution of assisted or controlled ventilation, if needed. Employ other supportive measures (including oxygen and vasopressors) in the management of circulatory shock and pulmonary edema as indicated. Cardiac arrest or arrhythmias will require advanced life-support measures. The opioid antagonists, naloxone or nalmefene, are specific antidotes to respiratory depression resulting from opioid overdose. For clinically significant respiratory or circulatory depression secondary to remifentanil overdose, stop the infusion or administer an opioid antagonist.

• Jul 12, 1996NDANDA020630Mylan Institutional
• Jan 16, 2018ANDAANDA206223Fresenius Kabi Usa
• Oct 13, 2020ANDAANDA210594Hikma

1. 1Anaphylactic Shock34415%
2. 2Hypotension1566.7%
3. 3Anaphylactic Reaction1446.2%
4. 4Cardiac Arrest1195.1%
5. 5Blood Pressure Decreased1024.4%
6. 6Bradycardia873.8%
7. 7Tachycardia873.8%
8. 8Bronchospasm783.4%
9. 9Rash693.0%
10. 10Erythema632.7%
11. 11Drug Ineffective592.5%
12. 12Toxic Epidermal Necrolysis592.5%
13. 13Oxygen Saturation Decreased582.5%
14. 14Drug Interaction542.3%
15. 15Off Label Use532.3%

Recent PubMed references pinned to Remifentanil as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

• Ciprofol-Esketamine Versus Ciprofol-Remifentanil in Hysteroscopic Endometrial Polypectomy: A Randomized Controlled Trial.
  Medical science monitor : international medical journal of experimental and clinical research · 2026 · Zhang Z, Wang Z, Gong W, et al.
  PMID 42226428DOI 10.12659/MSM.952468
• Respiratory Depression Following Concomitant Infusion of Remimazolam and Remifentanil Using Targeted Effect-Site Concentrations: A Randomized Controlled Trial.
  Medicina (Kaunas, Lithuania) · 2026 · Kim HY, Min SK, Moon JH, et al.
  PMID 42195193DOI 10.3390/medicina62050940
• Rescue of astrocytic ASCT1 expression and d-serine uptake attenuates remifentanil-induced hyperalgesia.
  Biochemical and biophysical research communications · 2026 · Chen C, Shi Y, Wan Y, et al.
  PMID 42161059DOI 10.1016/j.bbrc.2026.153944
• Safety and efficacy of esketamine versus remifentanil as adjuncts to propofol sedation in children undergoing haematologic-oncologic procedures in China: a single-centre, randomised, controlled, crossover trial protocol.
  BMJ open · 2026 · Xu S, Yang YF, Gao JM, et al.
  PMID 42156146DOI 10.1136/bmjopen-2025-109040
• Remifentanil patient-controlled analgesia for labour analgesia: guidance from the obstetric anaesthetists' association: Recommendations for well tolerated provision of remifentanil PCA for labour analgesia.
  European journal of anaesthesiology · 2026 · Hughes DA, Broom MA, Eley VA, et al.
  PMID 42080744DOI 10.1097/EJA.0000000000002373
• Comparison of the Effect of Different Administration Sequence of Propofol and Remifentanil on Sedation/Anesthesia During Gastroscopy in Obese Patients.
  Drug design, development and therapy · 2026 · Tang J, Zhong Z, Jiang H, et al.
  PMID 42064827DOI 10.2147/DDDT.S594697
• Effect of glucose load on metabolism in patients with type 2 diabetes during elective surgery using remifentanil-induced anesthesia:a randomized controlled trial.
  The journal of medical investigation : JMI · 2026 · Kasai A, Fukuta K, Kambe N, et al.
  PMID 42021080DOI 10.2152/jmi.73.222
• The Correlation Between Neoadjuvant Chemotherapy for Ovarian Cancer and the Analgesic Effects of Remifentanil a Prospective Cohort Study.
  Drug design, development and therapy · 2026 · Ding Y, Xing L, Paerhati H, et al.
  PMID 41947995DOI 10.2147/DDDT.S582499

The 10 most recently updated of 1,126 ClinicalTrials.gov registrations naming Remifentanil as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Transition From Sevoflurane to Total Intravenous Anesthesia in Pediatric Patients
  Not yet recruiting · Observational · 50 enrolled · Hospital de Clinicas José de San Martín
  NCT07644260updated 2026-06-12
• Impact of NOL Index Intraoperative Guided Remifentanil Analgesia
  Terminated · Interventional · 90 enrolled · Hopital Foch
  NCT04402242updated 2026-06-11
• COmbined pLaTelet and eRythrocyte AutotransfusioN During Cardiac surgEry (COLTRANE) Trial
  Recruiting · Interventional · 570 enrolled · University Hospital, Bordeaux
  NCT06425614updated 2026-06-11
• Sedation Methods in Percutaneous Transhepatic Biliary Drainage: Procedure Quality and Recovery
  Recruiting · Interventional · 98 enrolled · Ankara City Hospital Bilkent
  NCT07640243updated 2026-06-10
• Effect of Titrated Administration of Ciprofol on Perioperative Hypotension in Elderly Patients Undergoing Laparoscopic Abdominal Surgery: A Randomized Controlled Trial
  Recruiting · Interventional · 500 enrolled · Sixth Affiliated Hospital, Sun Yat-sen University
  NCT07328958updated 2026-06-10
• Comparison of M-TAPA and External Oblique Intercostal Block for Intraoperative Opioid Consumption in Laparoscopic Cholecystectomy
  Recruiting · Observational · 80 enrolled · Ankara Etlik City Hospital
  NCT07595679updated 2026-06-09
• The Effects of Anesthesia on Postoperative Cognitive Functions in Patients Undergoing Sleeve Gastrectomy
  Recruiting · Observational · 60 enrolled · Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital
  NCT07637357updated 2026-06-09
• Minto and Eleveld Remifentanil Target Controlled Infusion (TCI) Models: a Clinical Comparison
  Recruiting · Observational · 100 enrolled · University of Padova
  NCT07259291updated 2026-06-08
• Impact of Estimated Concentration of Propofol on Implicit Memory Formation
  Recruiting · Observational · 80 enrolled · University of Padova
  NCT06497855updated 2026-06-08
• HFNO Flow Rates and Cerebral Oxygenation During Deep Sedation for Cystoscopy
  Not yet recruiting · Interventional · 200 enrolled · Firat University
  NCT07630038updated 2026-06-05

CPIC-curated drug–gene pairs for Remifentanil. Levels describe the strength of curated evidence and guideline status — never a recommendation to test or to adjust therapy.

• COMTCPIC CClinPGx 3
  CYP2D6, OPRM1, COMT, and Opioids
• OPRM1CPIC CClinPGx 3
  CYP2D6, OPRM1, COMT, and Opioids

Frequently asked questions

How does Remifentanil work?

ULTIVA is a µ-opioid agonist with rapid onset and peak effect, and short duration of action. The µ-opioid activity of ULTIVA is antagonized by opioid antagonists such as naloxone.

What is Remifentanil used for?

According to FDA labeling, Remifentanil carries indications including: ULTIVA is indicated for intravenous (IV) administration: • As an analgesic agent for use during the induction and maintenance of general anesthesia for inpatient and outpatient procedures. • For continuation as an analgesic into the immediate postoperative period in adult patients under the direct supervision of an anesthesia practitioner in a postoperative anesthesia care unit or intensive care setting.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Remifentanil?

Remifentanil is classified as Opioid anesthetics, Opioid Agonist, Full Opioid Agonists, Analgesia, Decreased Organized Electrical Activity.

What are the brand names for Remifentanil?

Remifentanil is marketed under brand names including Ultiva.

What are the contraindications for Remifentanil?

Remifentanil labeling lists contraindications including: ULTIVA is contraindicated: • For epidural or intrathecal administration due to the presence of glycine in the formulation [see Nonclinical Toxicology (13) ] . • In patients with hypersensitivity to remifentanil (e.g., anaphylaxis) [see Adverse Reactions (6.2) ] .. Always consult the full prescribing information and a clinician.