Sevorane

Sevorane Adverse Reactions

sevoflurane

Manufacturer:

Abbvie

Distributor:

Zuellig
Full Prescribing Info
Adverse Reactions
As with all potent inhaled anesthetics, sevoflurane may cause dose-dependent cardiorespiratory depression. Most adverse events are mild or moderate 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 intraoperatively or postoperatively, and to the patient's response to the surgical procedure.
Clinical Trials: As with potent inhaled anesthetics, sevoflurane may cause dose-dependent cardiorespiratory depression. Most adverse events are mild or moderate 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 due to inhalational anesthetic, other agents administered intra-operatively or postoperatively, and to the patient's response to the surgical procedure. The most commonly reported adverse reactions were as follows: Adult Patients: Hypotension, nausea and vomiting.
Elderly Patients: Bradycardia, hypotension and nausea.
Pediatric Patients: Agitation, cough, vomiting and nausea.
All events, at least possibly related to sevoflurane from clinical trials are listed in Table as follows by MedDRA System Organ Class, Preferred Term and frequencies. The following frequency grouping 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 4.)

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ADR Post-Marketing Experience: Adverse events have been spontaneously reported during post approval use of sevoflurane. These events are reported voluntarily from population of an unknown rate of exposure. Therefore, it is not possible to estimate the true incidence of adverse events or establish a causal relationship to Sevoflurane exposure. (See Table 5.)

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