Sevoflurane Side Effects

Brand Names: Ultane

Please note - some side effects for Sevoflurane may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Sevoflurane - for the Consumer

Sevoflurane

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Sevoflurane:

Agitation; dizziness; drowsiness; increased cough; increased saliva; lightheadedness; nausea; shivering; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chills; fast, slow, or irregular heartbeat; fever; seizures; unusual change in amount or urine; yellowing of the skin or eyes.

Sevoflurane Side Effects - for the Professional

Sevoflurane

Adverse events are derived from controlled clinical trials conducted in the United States, Canada, and Europe. The reference drugs were isoflurane, enflurane, and propofol in adults and halothane in pediatric patients. The studies were conducted using a variety of premedications, other anesthetics, and surgical procedures of varying length. Most adverse events reported were mild and transient, and may reflect the surgical procedures, patient characteristics (including disease) and/or medications administered.

Of the 5182 patients enrolled in the clinical trials, 2906 were exposed to Sevoflurane, USP, including 118 adults and 507 pediatric patients who underwent mask induction. Each patient was counted once for each type of adverse event. Adverse events reported in patients in clinical trials and considered to be possibly or probably related to Sevoflurane, USP are presented within each body system in order of decreasing frequency in the following listings. One case of malignant hyperthermia was reported in pre-registration clinical trials.

See WARNINGS for information regarding malignant hyperthermia.

Adverse Events During Post-Marketing Experience:

Post-marketing reports indicate that Sevoflurane, USP use has been associated with seizures. The majority of cases were in children and young adults, most of whom had no medical history of seizures. Several cases reported no concomitant medications, and at least one case was confirmed by EEG. Although many cases were single seizures that resolved spontaneously or after treatment, cases of multiple seizures have also been reported. Seizures have occurred during, or soon after Sevoflurane, USP induction, during emergence, and during post-operative recovery up to a day following anesthesia.

Rare cases of malignant hyperthermia and allergic reactions, such as rash, urticaria, pruritis, bronchospasm, anaphylactic or anaphylactoid reactions have been reported.

Very rare cases of mild, moderate and severe post-operative hepatic dysfunction or hepatitis with or without jaundice have been reported. Histological evidence was not provided for any of the reported hepatitis cases. In most of these cases, patients had underlying hepatic conditions or were under treatment with drugs known to cause hepatic dysfunction. Most of the reported events were transient and resolved spontaneously. In addition, there have been rare post-marketing reports of hepatic failure and hepatic necrosis associated with the use of potent volatile anesthetic agents, including Sevoflurane, USP. However, the actual incidence and relationship of Sevoflurane, USP to these events cannot be established with certainty.

Laboratory Findings:

Transient elevations in glucose, liver function tests, and white blood cell count may occur as with use of other anesthetic agents.

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