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  1. Malignant hyperthermia (see WARNINGS).
  2. Motor activity exemplified by movements of various muscle groups and/or seizures may be encountered with deep levels of ETHRANE (enflurane, USP) anesthesia, or light levels with hypocapnia.
  3. Hypotension, respiratory depression, and hypoxia have been reported.
  4. Arrhythmias, shivering, nausea and vomiting have been reported.
  5. Elevation of the white blood count has been observed.
  6. Mild, moderate and severe liver injury, including hepatic failure, may rarely follow anesthesia with enflurane. Serum transaminases may be increased and histologic evidence of injury may be found. The histologic changes are neither unique nor consistent. In several of these cases, it has not been possible to exclude enflurane as the cause or as a contributing cause to liver injury. The incidence of unexplained hepatotoxicity following the administration of enflurane is unknown, but it appears to be rare and not dose related.

ETHRANE (enflurane, USP) has also been associated with perioperative hyperkalemia (see WARNINGS).

Post-Marketing Events

The following adverse events have been identified during post-approval use of ETHRANE (enflurane, USP). Due to the spontaneous nature of these reports, the actual incidence and relationship of ETHRANE (enflurane, USP) to these events cannot be established with certainty.

Cardiac Disorders: Cardiac arrest

Hepatobiliary Disorders: Hepatic necrosis, Hepatic failure