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Propofol

Generic Name
Propofol
Brand Names
Diprivan
Drug Type
Small Molecule
Chemical Formula
C12H18O
CAS Number
2078-54-8
Unique Ingredient Identifier
YI7VU623SF

Overview

Propofol is an intravenous anaesthetic agent used for induction and maintenance of general anaesthesia. IV administration of propfol is used to induce unconsciousness after which anaesthesia may be maintained using a combination of medications. Recovery from propofol-induced anaesthesia is generally rapid and associated with less frequent side effects (e.g. drowsiness, nausea, vomiting) than with thiopental, methohexital, and etomidate. Propofol may be used prior to diagnostic procedures requiring anaesthesia, in the management of refractory status epilepticus, and for induction and/or maintenance of anaesthesia prior to and during surgeries.

Indication

Used for induction and/or maintenance of anaesthesia and for management of refractory status epilepticus.

Associated Conditions

No associated conditions information available.

Research Report

Published: Jul 16, 2025

Propofol (DB00818): A Comprehensive Clinical and Pharmacological Monograph

Introduction

Propofol, chemically identified as 2,6-diisopropylphenol, is a short-acting, intravenously administered hypnotic agent that has become a cornerstone of modern anesthetic practice.[1] Since its widespread introduction, it has fundamentally reshaped the landscape of anesthesia, primarily due to a highly favorable pharmacokinetic profile characterized by rapid and smooth induction of anesthesia, predictable dose-dependent effects, and a clear-headed, swift recovery.[3] These properties have been instrumental in facilitating the global expansion of ambulatory (day-case) surgery and have established propofol as the principal agent for total intravenous anesthesia (TIVA) techniques.[4] Its utility extends beyond the operating room to procedural sedation and the sedation of critically ill patients in the intensive care unit (ICU).[3]

This clinical versatility, however, is balanced by a significant and demanding risk profile. Propofol possesses a narrow therapeutic window, meaning the dose required for sedation is close to that which can cause profound, life-threatening cardiorespiratory depression, including hypotension, apnea, and loss of protective airway reflexes.[9] This inherent risk is compounded by the lack of a specific pharmacological reversal agent, mandating its administration by personnel expertly trained in general anesthesia and advanced airway management.[12] Furthermore, its lipid emulsion formulation creates a potential vector for microbial contamination if strict aseptic technique is not followed.[3] The drug also carries a potential for abuse, particularly among healthcare professionals, and is associated with the rare but often lethal complication of Propofol Infusion Syndrome (PRIS) when used at high doses or for prolonged periods.[12]

Continue reading the full research report

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor
2025/08/12
Not Applicable
Not yet recruiting
2025/08/12
Not Applicable
Not yet recruiting
Xijing Hospital
2025/07/31
Not Applicable
Not yet recruiting
2025/07/29
Not Applicable
Active, not recruiting
2025/07/25
Not Applicable
Not yet recruiting
Jinqiao Qian
2025/07/24
Not Applicable
Completed
Children's Hospital of Hebei Province
2025/07/23
Not Applicable
ENROLLING_BY_INVITATION
Tamas Vegh, MD
2025/07/22
Not Applicable
Not yet recruiting
2025/07/22
Not Applicable
Completed
2025/07/14
Not Applicable
Recruiting

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Dr. Reddy's Laboratories, Inc.
43598-548
INTRAVENOUS
10 mg in 1 mL
9/30/2022
General Injectables & Vaccines, Inc
52584-269
INTRAVENOUS
10 mg in 1 mL
1/18/2017
Sagent Pharmaceuticals
25021-608
INTRAVENOUS
10 mg in 1 mL
2/3/2023
A-S Medication Solutions
50090-4569
INTRAVENOUS
10 mg in 1 mL
2/29/2020
Fresenius Kabi USA, LLC
63323-269
INTRAVENOUS
10 mg in 1 mL
9/15/2023
Hospira, Inc.
0409-6010
INTRAVENOUS
10 mg in 1 mL
2/14/2023
Hospira, Inc.
0409-4699
INTRAVENOUS
10 mg in 1 mL
2/14/2023
Amneal Pharmaceuticals Private Limited
80830-2365
INTRAVENOUS
10 mg in 1 mL
5/20/2025
Hikma Pharmaceuticals USA Inc.
0641-6196
INTRAVENOUS
10 mg in 1 mL
11/18/2022
Fresenius Kabi USA, LLC
63323-269
INTRAVENOUS
10 mg in 1 mL
3/24/2023

EMA Drug Approvals

Approved Product
Authorization Holder
Status
Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
PROPOFOL-LIPURO EMULSION FOR INJECTION/INFUSION 500MG/50ML
N/A
N/A
N/A
7/3/2019

Health Canada Drug Approvals

Approved Product
Company
DIN
Dosage Form
Strength
Market Date
DIPRIVAN 1%
02018950
Emulsion - Intravenous
10 MG / ML
12/31/1993
TEVA-PROPOFOL
teva canada limited
02437961
Emulsion - Intravenous
10 MG / ML
11/20/2015
PROPOFOL
baxter corporation
02468336
Emulsion - Intravenous
10 MG / ML
4/24/2018
PROPOFOL INJECTION
fresenius kabi canada ltd
02437643
Emulsion - Intravenous
10 MG / ML
6/1/2015
PROPOFOL-II INJECTION
02376865
Emulsion - Intravenous
10 MG / ML
6/11/2013
PROPOFOL INJECTION
baxter corporation
02244379
Emulsion - Intravenous
10 MG / ML
3/1/2002
PROPOFOL INJECTION
hospira healthcare ulc
02242973
Emulsion - Intravenous
10 MG / ML
4/2/2004
PROPOFOL INJECTION
marcan pharmaceuticals inc
02525879
Emulsion - Intravenous
10 MG / ML
4/18/2023
PROPOFOL INJECTION
02236887
Emulsion - Intravenous
10 MG / ML
2/5/1998

CIMA AEMPS Drug Approvals

Approved Product
Company
Registration Number
Pharmaceutical Form
Prescription Type
Status
DIPRIVAN 10 mg/ml EMULSION INYECTABLE Y PARA PERFUSION
58785
EMULSIÓN INYECTABLE Y PARA PERFUSIÓN
Uso Hospitalario
Commercialized
PROPOFOL SANDOZ 20 MG/ML EMULSION INYECTABLE Y PARA PERFUSION EFG
Sandoz Farmaceutica S.A.
76392
EMULSIÓN INYECTABLE Y PARA PERFUSIÓN
Uso Hospitalario
Not Commercialized
PROPOFOL SANDOZ 10 MG/ML EMULSION INYECTABLE Y PARA PERFUSION EFG
Sandoz Farmaceutica S.A.
76391
EMULSIÓN INYECTABLE Y PARA PERFUSIÓN
Uso Hospitalario
Not Commercialized
DIPRIVAN 20 mg/ml EMULSION PARA PERFUSION
60744
EMULSIÓN INYECTABLE Y PARA PERFUSIÓN
Uso Hospitalario
Commercialized
PROPOFOL FRESENIUS 20 MG/ML EMULSION INYECTABLE Y PARA PERFUSION EFG
64033
EMULSIÓN INYECTABLE Y PARA PERFUSIÓN
Uso Hospitalario
Not Commercialized
PROPOFOL LIPOVEN FRESENIUS 20 mg/ml EMULSION INYECTABLE Y PARA PERFUSION
67216
EMULSIÓN INYECTABLE Y PARA PERFUSIÓN
Uso Hospitalario
Commercialized
PROPOFOL FARMAK 20 MG/ML EMULSION INYECTABLE Y PARA PERFUSION EFG
Farmak International Sp. Z O.O.
89617
EMULSIÓN INYECTABLE Y PARA PERFUSIÓN
Uso Hospitalario
Not Commercialized
PROPOFOL LIPOVEN FRESENIUS 20 MG/ML EMULSION INYECTABLE Y PARA PERFUSION EN JERINGA PRECARGADA EFG
77590
EMULSIÓN INYECTABLE Y PARA PERFUSIÓN
Uso Hospitalario
Not Commercialized
PROPOFOL BIOQ 10 MG/ML EMULSION PARA PERFUSION EN SISTEMA DE ADMINISTRACION
Bioq Pharma B.V.
83629
EMULSIÓN PARA PERFUSIÓN EN SISTEMA DE ADMINISTRACIÓN
Uso Hospitalario
Not Commercialized
PROPOFOL LIPURO 10 mg/ml EMULSIÓN INYECTABLE Y PARA PERFUSIÓN
62953
EMULSIÓN INYECTABLE Y PARA PERFUSIÓN
Uso Hospitalario
Commercialized

Philippines FDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product
Company
Registration Number
Dosage Form
Strength
Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name
MA Holder
MA Number
Pharmaceutical Form
Active Ingredient
Authorization Date
No UK EMC drug information found for this drug.

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