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PROPOFOL
PROPOFOL is a General Anesthetic [EPC] drug. It is currently FDA-approved (first approved 1989) for Induction of General Anesthesia, Maintenance of General Anesthesia, Initiation and Maintenance of MAC Sedation.
Propofol is a marketed anesthetic agent primarily indicated for the induction of general anesthesia, holding a significant position in the anesthesiology market. Its key strength lies in its well-established efficacy and safety profile, supported by extensive clinical use. The primary risk to consider is the key composition patent expiry in 2028, which could lead to increased competition from generic alternatives.
At a glance
| Generic name | PROPOFOL |
|---|---|
| Drug class | General Anesthetic [EPC] |
| Modality | Small molecule |
| Phase | FDA-approved |
| First approval | 1989 |
Approved indications
- Induction of General Anesthesia
- Maintenance of General Anesthesia
- Initiation and Maintenance of MAC Sedation
- Sedation in Combination with Regional Anesthesia
- ICU Sedation
Common side effects
- Respiratory depression
- Apnea
- Tachypnea
- Labored breathing
- Hypotension
- Bradycardia
- Tachycardia
- Arrhythmias
- Hypertension
- Fasciculations
- Emesis
- Excitation
Serious adverse events
- Seizures
- Excessive depression
- Opisthotonos
Drug interactions
- Opioids (e.g., morphine, meperidine, fentanyl)
- Sedatives (e.g., benzodiazepines, barbiturates, chloral hydrate, droperidol)
- Analgesic Agents (e.g., nitrous oxide, opioids)
- Potent Inhalational Agents (e.g., isoflurane, sevoflurane, desflurane, enflurane, halothane)
- Valproate
Key clinical trials
- Total Intravenous and Balanced Anesthesia in Diabetic Patients Undergoing Video-Assisted Thoracoscopy (PHASE4)
- The Relationship Between Opioid-Free Anesthesia and Postoperative Agitation-Delirium and Quality of Recovery in Pediatric Ear, Nose, and Throat Cases Monitored With Perioperative Bispectral Index
- EEG and Pain Monitor Data Under Anesthesia to Study Pharmacodynamic Effects of Opioids and Sedatives (NA)
- Comparison of Two Intravenous Drug Combinations for Ambulatory Oral & Maxillofacial Surgery (PHASE1)
- Effect of Remimazolam and Propofol on Postoperative Delirium (NA)
- Hemodynamic Effects of Remimazolam vs Propofol During Robot-assisted Gynecologic Surgery (NA)
- Propofol Versus Sevoflurane Anesthesia on the Intraocular Pressure and Hemodynamics in Patient Undergoing Cyclophotocoagulation (NA)
- Actualities in Procedural Sedation: Remimazolam (PHASE4)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- PROPOFOL CI brief — competitive landscape report
- PROPOFOL updates RSS · CI watch RSS
Frequently asked questions about PROPOFOL
What is PROPOFOL?
What is PROPOFOL used for?
What drug class is PROPOFOL in?
When was PROPOFOL approved?
What development phase is PROPOFOL in?
What are the side effects of PROPOFOL?
Related
- Drug class: All General Anesthetic [EPC] drugs
- Indication: Drugs for Induction of General Anesthesia
- Indication: Drugs for Maintenance of General Anesthesia
- Indication: Drugs for Initiation and Maintenance of MAC Sedation
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing