Suprane Adverse Reactions

Clinical Trials Experience: Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Adverse event information is derived from controlled clinical trials, the majority of which were conducted in the United States. 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 2,143 patients exposed to SUPRANE in clinical trials, 370 adults and 152 children were induced with desflurane alone and 987 patients were maintained principally with desflurane. The frequencies given reflect the percent of patients with the event. Each patient was counted once for each type of adverse event. They are presented in alphabetical order according to body system. (See Table 9.)

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Post-Marketing Experience: The following adverse reactions have been identified during post-approval use of SUPRANE. Because these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Blood and Lymphatic System Disorders: Coagulopathy.
Metabolism and Nutrition Disorders: Hyperkalemia, Hypokalemia, metabolic acidosis.
Nervous System Disorders: Convulsion, Post-operative agitation in children.
Eye Disorders: Ocular icterus.
Cardiac Disorders: Cardiac arrest, QTc prolongation, Torsade de pointes, ventricular failure, ventricular hypokinesia, atrial fibrillation.
Vascular Disorders: Malignant hypertension, hemorrhage, hypotension, shock.
Respiratory, Thoracic and Mediastinal Disorders: Respiratory arrest, respiratory failure, respiratory distress, bronchospasm, hemoptysis.
Gastrointestinal Disorders: Pancreatitis acute, abdominal pain.
Hepatobiliary Disorders: Hepatic failure, hepatic necrosis, hepatitis, cytolytic hepatitis, cholestasis, jaundice, hepatic function abnormal, liver disorder.
Skin and Subcutaneous Tissue Disorder: Urticaria, erythema.
Musculoskeletal, Connective Tissue and Bone Disorders: Rhabdomyolysis.
General Disorders and Administration Site Conditions: Hyperthermia malignant, asthenia, malaise.
Investigations: Electrocardiogram ST-T change, electrocardiogram T-wave inversion, transaminases increased, alanine aminotransferase increased, aspartate aminotransferase increased, blood bilirubin increased, coagulation test abnormal, ammonia increased.
Injury, Poisoning, and Procedural Complications*: Tachyarrhythmia, palpitations, eye burns, blindness transient, encephalopathy, ulcerative keratitis, ocular hyperemia, visual acuity reduced, eye irritation, eye pain, dizziness, migraine, fatigue, accidental exposure, skin burning sensation, drug administration error.
*Reactions categorized within this System Organ Class (SOC) were accidental exposures to non-patients.