SUGAMMADEX for Surgery: Side Effects & Safety Data
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There are 28 adverse event reports in the FDA FAERS database where SUGAMMADEX was used for Surgery.
Most Reported Side Effects for SUGAMMADEX
| Side Effect | Reports | % | Deaths | Hosp. |
|---|---|---|---|---|
| Anaphylactic reaction | 338 | 14.8% | 12 | 140 |
| Bradycardia | 293 | 12.9% | 27 | 76 |
| Cardiac arrest | 198 | 8.7% | 30 | 71 |
| Bronchospasm | 182 | 8.0% | 7 | 52 |
| Anaphylactic shock | 176 | 7.7% | 6 | 69 |
| Hypotension | 155 | 6.8% | 10 | 50 |
| Recurrence of neuromuscular blockade | 113 | 5.0% | 5 | 29 |
| Drug ineffective | 108 | 4.7% | 1 | 36 |
| Oxygen saturation decreased | 91 | 4.0% | 2 | 38 |
| Off label use | 71 | 3.1% | 1 | 10 |
| Hypoxia | 59 | 2.6% | 3 | 27 |
| Blood pressure decreased | 55 | 2.4% | 7 | 19 |
| Maternal exposure during pregnancy | 53 | 2.3% | 0 | 6 |
| Dyspnoea | 52 | 2.3% | 2 | 20 |
| Tachycardia | 49 | 2.2% | 2 | 22 |
Other Indications for SUGAMMADEX
Neuromuscular blockade reversal (1,191)
Product used for unknown indication (128)
Anaesthesia reversal (86)
Neuromuscular blockade (49)
Anaesthesia (46)
General anaesthesia (25)
Adverse drug reaction (14)
Obstructive airways disorder (13)
Muscle relaxant therapy (12)
Reversal of sedation (12)
Other Drugs Used for Surgery
OXYCODONE (339)
MORPHINE (141)
PROPOFOL (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)