M & H Sevoflurane USP Adverse Reactions

As with all potent inhaled anesthetics, sevoflurane may cause dose-dependent cardio-respiratory depression. Most adverse events are mild or moderated in severity and transient in duration. Nausea and vomiting have been observed in the postoperative period, common sequelae of surgery and general anesthesia, which may be due to inhalational anesthetic, other agents administered intra-operatively or post-operatively, and to the patient's response to the surgical procedure.
Effects on the cardiovascular system: The cardiovascular effects of sevoflurane are similar to those of isoflurane but it does not produce coronary steal. Also, sevoflurane produces less tachycardia than isoflurane suggesting that it may be preferable in those predisposed to myocardial ischemia.
Effects on the kidneys: Investigations of the nephrotoxic potential of sevoflurane have found no evidence of renal function impairment despite peak plasma-fluoride ion concentrations greater than 50 nanomol/mL being recorded in some patients at the end of sevoflurane anesthesia.
Effects on the liver: There have been signs of hepatotoxicity in animal studies but in studies in humans, markers for hepatocellular dysfunction were no greater after sevoflurane anesthesia than those after isoflurane.
Effect on the nervous system: Sevoflurane has been shown to have a dose-related epileptogenic effect although the mechanism is unknown. Tonic-clonic seizure-like movements associated with induction of anaesthesia using sevoflurane have been reported particularly in children with or without a personal and/or family history of tonic-clonic seizure.
The most commonly reported adverse reactions were as follows: In adult patients: hypotension, nausea and vomiting.
In elderly patients: bradycardia, hypotension and nausea.
In pediatric patients: agitation, cough, vomiting and nausea.
All events, at least possibly related to sevoflurane from clinical trials, are displayed in the Table 2 as follows by MedDRA System Organ Class, Preferred Term and frequency. The following frequency groupings are used: Very common (>1/10); common (>1/100 and 1/10); uncommon (>1/1,000 and <1/100); rare (>1/10,000 and <1/1,000); very rare (<1/10,000), including isolated reports. The type, severity, and frequency of adverse events in sevoflurane patients were comparable to adverse events in reference-drug patients. (See Table 2.)

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Drug abuse and dependence: None known.