PROPOFOL for Sedation: Side Effects & Safety Data
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There are 1,714 adverse event reports in the FDA FAERS database where PROPOFOL was used for Sedation.
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)
Sedative therapy (904)
Status epilepticus (752)
Maintenance of anaesthesia (247)
Seizure (234)
Anaesthesia procedure (215)
Induction and maintenance of anaesthesia (187)
Other Drugs Used for Sedation
MIDAZOLAM (1,360)
DEXMEDETOMIDINE (859)
FENTANYL (706)
SUFENTANIL (413)
KETAMINE (283)
MIDAZOLAM\MIDAZOLAM (197)
DIAZEPAM (194)
LORAZEPAM (193)
REMIFENTANIL (176)
MORPHINE (131)