Propofol

The mechanism of action, like all general anesthetics, is poorly understood. However, propofol is thought to produce its sedative/anesthetic effects by the positive modulation of the inhibitory function of the neurotransmitter GABA through the ligand-gated GABA A receptors.

• Propofol injectable emulsion is an intravenous general anesthetic and sedation drug indicated for: Induction of General Anesthesia for Patients Greater than or Equal to 3 Years of Age Maintenance of General Anesthesia for Patients Greater than or Equal to 2 Months of Age Initiation and Maintenance of Monitored Anesthesia Care (MAC) Sedation in Adult Patients Sedation for Adult Patients in Combination with Regional Anesthesia Intensive Care Unit (ICU) Sedation of Intubated, Mechanically Ventilated Adult Patients Limitations of Use Propofol injectable emulsion is not recommended for induction of anesthesia below the age of 3 years or for maintenance of anesthesia below the age of 2 months because its safety and effectiveness have not been established in those populations [see Pediatric Use ( 8.4 )] . Safety, effectiveness and dosing guidelines for propofol injectable emulsion have not been established for MAC sedation in the pediatric population; therefore, it is not recommended for this use [see Pediatric Use ( 8.4 )].

• Propofol injectable emulsion is contraindicated in patients with a known hypersensitivity to propofol or any of propofol injectable emulsion components. Propofol injectable emulsion is contraindicated in patients with a history of anaphylaxis to eggs, egg products, soybeans or soy products.contraindicated

See Full Prescribing Information for detailed dosing instructions. 2.1 Important Dosage and Administration Information Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Shake well before use. Do not use if there is evidence of excessive creaming or aggregation, if large droplets are visible, or if there are other forms of phase separation indicating that the stability of the product has been compromised. Slight creaming, which should disappear after shaking, may be visible upon prolonged standing. Do not use if there is evidence of separation of the phases of the emulsion. Propofol injectable emulsion with EDTA inhibits microbial growth for up to 12 hours, as demonstrated by test data for representative USP microorganisms. Product is packaged under nitrogen. For general anesthesia or monitored anesthesia care (MAC) sedation, propofol injectable emulsion should be administered only by persons trained in the administration of general anesthesia and not involved in the conduct of the surgical/diagnostic procedure. Sedated patients should be continuously monitored, and equipment for maintaining a patent airway, providing artificial ventilation, administering supplemental oxygen, and instituting cardiovascular resuscitation must be immediately available. Patients should be continuously monitored for early signs of hypotension, apnea, airway obstruction, and/or oxygen desaturation.

Hypersensitivity Reactions : Serious and sometimes fatal reactions ( 5.1 ) Microbial Contamination : Strict aseptic technique must be maintained during handling. Propofol injectable emulsion vials are never to be accessed more than once or used on more than one person. Administration should commence promptly and be completed within 12 hours after the vial has been opened. Discard unused drug product. Do not use if contamination is suspected ( 5.2 ) Cardiovascular depression : Cases of bradycardia, asystole, and cardiac arrest have been reported. Pediatric patients are susceptible to this effect, particularly when fentanyl is given concomitantly ( 5.4 ) 5.1 Anaphylactic and Anaphylactoid Reactions Use of propofol injectable emulsion has been associated with both fatal and life threatening anaphylactic and anaphylactoid reactions. Clinical features of anaphylaxis, including angioedema, bronchospasm, erythema, and hypotension, occur rarely following propofol injectable emulsion administration. 5.2 Risks of Microbial Contamination Strict aseptic technique must always be maintained during handling. Propofol injectable emulsion is a single-dose parenteral product (single patient infusion vial) which contains 0.005% disodium edetate (EDTA) to inhibit the rate of growth of microorganisms, for up to 12 hours, in the event of accidental extrinsic contamination. However, propofol injectable emulsion can still support the growth of microorganisms, as it is not an antimicrobially preserved product under USP standards. Do not use if contamination is suspected.

The following serious or otherwise important adverse reactions are discussed elsewhere in the labeling: Hypersensitivity reaction [see Warnings and Precautions ( 5.1 )] Hypotension and/or bradycardia [see Warnings and Precautions ( 5.4 )] Propofol Infusion Syndrome [see Warnings and Precautions ( 5.9 )] In the description below, rates of the more common events represent US/Canadian clinical study results. Less frequent events are also derived from publications and marketing experience in over 8 million patients; there are insufficient data to support an accurate estimate of their incidence rates. These studies were conducted using a variety of premedicants, varying lengths of surgical/diagnostic procedures, and various other anesthetic/sedative agents. Most adverse events were mild and transient. 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. Anesthesia and MAC Sedation in Adults The following estimates of adverse events for propofol injectable emulsion include data from clinical trials in general anesthesia/MAC sedation (N=2,889 adult patients). The adverse events listed below as probably causally related are those events in which the actual incidence rate in patients treated with propofol injectable emulsion was greater than the comparator incidence rate in these trials.

8.1 Pregnancy Risk Summary Data from randomized controlled trials, cohort studies and case series over several decades with propofol use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Most of the reported exposures to propofol describe propofol exposure at the time of cesarean delivery. There are reports of neonatal depression in infants exposed to propofol during delivery (see Clinical Considerations). In animal reproduction studies, decreased pup survival concurrent with increased maternal mortality was observed with intravenous administration of propofol to pregnant rats either prior to mating and during early gestation or during late gestation and early lactation at exposures less than the human induction dose of 2.5 mg/kg. In pregnant rats administered 15 mg/kg/day intravenous propofol (equivalent to the human induction dose) from two weeks prior to mating to early in gestation (Gestation Day 7), offspring that were allowed to mate had increased postimplantation losses. The pharmacological activity (anesthesia) of the drug on the mother is probably responsible for the adverse effects seen in the offspring.

Metabolism

The pharmacokinetics of propofol are well described by a three- compartment linear model with compartments representing the plasma, rapidly equilibrating tissues, and slowly equilibrating tissues. Following an intravenous bolus dose, there is rapid equilibration between the plasma and the brain, accounting for the rapid onset of anesthesia.

10.1 Symptoms Overdosage is likely to cause cardiorespiratory depression. 10.2 Treatment If overdosage occurs, propofol injectable emulsion administration should be discontinued immediately. Respiratory depression should be treated by artificial ventilation with oxygen. Cardiovascular depression may require repositioning of the patient by raising the patient's legs, increasing the flow rate of intravenous fluids, and administering pressor agents and/or anticholinergic agents.

• Oct 2, 1989NDANDA019627Fresenius Kabi Usa
• Jan 4, 1999ANDAANDA075102Sagent Pharms Inc
• Apr 19, 2005ANDAANDA074848Hikma
• Mar 17, 2006ANDAANDA077908Hospira
• Nov 15, 2018ANDAANDA205067Dr Reddys
• Sep 16, 2020ANDAANDA205576Innopharma
• Oct 12, 2021ANDAANDA206408Avet Lifesciences
• Aug 15, 2024ANDAANDA217525Amneal

1. 1Hypotension2,8768.0%
2. 2Drug Ineffective2,7617.7%
3. 3Anaphylactic Shock2,0355.7%
4. 4Cardiac Arrest1,8075.1%
5. 5Anaphylactic Reaction1,6704.7%
6. 6Off Label Use1,6554.6%
7. 7Drug Interaction1,5454.3%
8. 8Tachycardia1,1973.3%
9. 9Bradycardia1,1793.3%
10. 10Pyrexia1,0012.8%
11. 11Acute Kidney Injury9852.8%
12. 12Rhabdomyolysis9092.5%
13. 13Renal Failure8052.3%
14. 14Bronchospasm8032.2%
15. 15Oxygen Saturation Decreased8022.2%

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

• Differential effects of sevoflurane versus propofol on calmodulin expression in breast cancer patients.
  Pakistan journal of pharmaceutical sciences · 2026 · Wang J, He B, Kuerban G, et al.
  PMID 42262213DOI 10.36721/PJPS.2026.39.8.239.1
• Association between venous access-site closure device use and postoperative nausea and vomiting after atrial fibrillation ablation under propofol sedation: a single-centre retrospective observational study in Okayama, Japan.
  BMJ open · 2026 · Sakanoue H, Yamaji H, Okamoto S, et al.
  PMID 42236090DOI 10.1136/bmjopen-2026-117719
• Efficacy and Safety of Ciprofol versus Propofol for Tracheal Intubation in Pediatric Patients Undergoing Laparoscopic Hernia Repair: An Assessor-Blinded Randomised Controlled Trial.
  Drug design, development and therapy · 2026 · Pan J, Zhong T, Lv Y, et al.
  PMID 42206234DOI 10.2147/DDDT.S602666
• Effects of Fospropofol on intraoperative hemodynamics in patients undergoing Supratentorial tumor resection: A randomized controlled trial.
  Journal of clinical anesthesia · 2026 · Sun Y, Chen Y, Zhuang W, et al.
  PMID 42176429DOI 10.1016/j.jclinane.2026.112237
• Does previous COVID-19 severity affect propofol sedation safety during ERCP?: A prospective observational study.
  Medicine · 2026 · Sahap M, Lafci A, Aydemir O, et al.
  PMID 42175509DOI 10.1097/MD.0000000000049049
• Vitamin D alleviates neurotoxicity induced by propofol anaesthesia in the offspring of mice.
  PloS one · 2026 · Solmaz HC, Karacaer F, Biricik E, et al.
  PMID 42172230DOI 10.1371/journal.pone.0349784
• The Influence of Remimazolam versus Propofol on Quality of Emergence and Sleep in Elderly Patients After Spinal Surgery: A Non-Randomized Observational Study.
  Drug design, development and therapy · 2026 · Zhang J, Zhao B, Liu B, et al.
  PMID 42157791DOI 10.2147/DDDT.S593190
• 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

The 10 most recently updated of 2,741 ClinicalTrials.gov registrations naming Propofol as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• The Effects of Different Anesthetics on the Brain's Neural Networks
  Not yet recruiting · Phase 4 · Interventional · 120 enrolled · Fudan University
  NCT07644663updated 2026-06-12
• 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
• Efficacy of Propofol Combination With Either Ketamine, Dexmedetomidine or Midazolam for Sedation During Upper Gastrointestinal Endoscopic Procedures
  Completed · Phase 4 · Interventional · 75 enrolled · Ain Shams University
  NCT07190612updated 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
• Personalized Music, Dreaming During Propofol Sedation
  Not yet recruiting · Interventional · 300 enrolled · Wonkwang University Hospital
  NCT07638072updated 2026-06-10
• RemImazolam Besylate for ICU-sedation in Patients With Mechanical Ventilation After Oral and Maxillofacial Surgery
  Suspended · Phase 4 · Interventional · 117 enrolled · Nanfang Hospital, Southern Medical University
  NCT05606315updated 2026-06-10
• Internal Jugular Vein Ultrasound and Acute Kidney Injury After Abdominal Surgery
  Not yet recruiting · Observational · 150 enrolled · Tîrgu Mureș Emergency Clinical County Hospital, Romania
  NCT07638306updated 2026-06-10
• Blocking Sphenopalatine Ganglion by Intranasal Lidocaine Spray in Partial Turbinectomy Surgeries
  Recruiting · Phase 3 · Interventional · 50 enrolled · Ain Shams University
  NCT07299630updated 2026-06-09
• Patient Controlled Propofol Sedation Versus Standard Sedation in Advanced Therapeutic Colonoscopy With a Focus on Patient Satisfaction
  Not yet recruiting · Phase 4 · Interventional · 40 enrolled · Karolinska Institutet
  NCT07637279updated 2026-06-09

Frequently asked questions

How does Propofol work?

The mechanism of action, like all general anesthetics, is poorly understood. However, propofol is thought to produce its sedative/anesthetic effects by the positive modulation of the inhibitory function of the neurotransmitter GABA through the ligand-gated GABA A receptors.

What is Propofol used for?

According to FDA labeling, Propofol carries indications including: Propofol injectable emulsion is an intravenous general anesthetic and sedation drug indicated for: Induction of General Anesthesia for Patients Greater than or Equal to 3 Years of Age Maintenance of General Anesthesia for Patients Greater than or Equal to 2 Months of Age Initiation and Maintenance of Monitored Anesthesia Care (MAC) Sedation in Adult Patients Sedation for Adult Patients in Combination with Regional Anesthesia Intensive Care Unit (ICU) Sedation of Intubated, Mechanically Ventilated Adult Patients Limitations of Use Propofol injectable emulsion is not recommended for induction of anesthesia below the age of 3 years or for maintenance of anesthesia below the age of 2 months because its safety and effectiveness have not been established in those populations [see Pediatric Use ( 8.4 )] . Safety, effectiveness and dosing guidelines for propofol injectable emulsion have not been established for MAC sedation in the pediatric population; therefore, it is not recommended for this use [see Pediatric Use ( 8.4 )].. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Propofol?

Propofol is classified as Other general anesthetics, General Anesthetic, GABA A Modulators, Decreased Central Nervous System Disorganized Electrical Activity, Decreased Central Nervous System Organized Electrical Activity, Decreased Peripheral Nervous System Organized Electrical Activity, General Anesthesia.

What are the brand names for Propofol?

Propofol is marketed under brand names including Diprivan, Propoflo, Propovan, Propoven.

What are the contraindications for Propofol?

Propofol labeling lists contraindications including: Propofol injectable emulsion is contraindicated in patients with a known hypersensitivity to propofol or any of propofol injectable emulsion components. Propofol injectable emulsion is contraindicated in patients with a history of anaphylaxis to eggs, egg products, soybeans or soy products.. Always consult the full prescribing information and a clinician.