PROPOFOL for Surgery: Side Effects & Safety Data
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There are 141 adverse event reports in the FDA FAERS database where PROPOFOL was used for Surgery.
Most Reported Side Effects for PROPOFOL
| Side Effect | Reports | % | Deaths | Hosp. |
|---|---|---|---|---|
| Drug ineffective | 1,627 | 10.1% | 298 | 841 |
| Anaphylactic shock | 1,494 | 9.3% | 72 | 424 |
| Hypotension | 1,388 | 8.6% | 117 | 646 |
| Off label use | 889 | 5.5% | 211 | 483 |
| Anaphylactic reaction | 862 | 5.4% | 37 | 312 |
| Cardiac arrest | 758 | 4.7% | 293 | 325 |
| Bradycardia | 470 | 2.9% | 56 | 205 |
| Tachycardia | 464 | 2.9% | 38 | 212 |
| Propofol infusion syndrome | 420 | 2.6% | 169 | 193 |
| Foetal exposure during pregnancy | 389 | 2.4% | 58 | 101 |
| Toxicity to various agents | 381 | 2.4% | 245 | 191 |
| Product use in unapproved indication | 367 | 2.3% | 55 | 155 |
| Rhabdomyolysis | 365 | 2.3% | 75 | 207 |
| Bronchospasm | 356 | 2.2% | 15 | 112 |
| Rash | 354 | 2.2% | 27 | 173 |
Other Indications for PROPOFOL
Anaesthesia (2,503)
General anaesthesia (2,292)
Product used for unknown indication (2,240)
Induction of anaesthesia (2,072)
Sedation (1,714)
Sedative therapy (904)
Status epilepticus (752)
Maintenance of anaesthesia (247)
Seizure (234)
Anaesthesia procedure (215)
Other Drugs Used for Surgery
OXYCODONE (339)
MORPHINE (141)
COAGULATION FACTOR IX HUMAN\COAGULATION FACTOR VII HUMAN\COAGULATION FACTOR X HUMAN\PROTEIN C\PROTEIN S HUMAN\PROTHROMBIN (132)
ROCURONIUM (130)
BUPIVACAINE (129)
DEXAMETHASONE (127)
ACETAMINOPHEN\OXYCODONE (102)
FENTANYL (101)
ACETAMINOPHEN\HYDROCODONE (95)
POLYETHYLENE GLYCOL 3350 (89)