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U.S. Department of Health and Human Services

Safety

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Suprane (desflurane, USP)

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- April 2009

 

The detailed view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE sections. Deletions or editorial revisions made to these sections are not included in this summary. Read about the new physician labeling format.


Summary View

 

Brand (Generic) Name

Sections Modified

Suprane (desflurane, USP)

ADVERSE REACTIONS

  • Post Marketing Reports
    The following adverse reactions have been identified during post-approval use of Suprane (desflurane, USP). 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
    • Eye Disorders: Ocular icterus
    • Cardiac Disorders: Cardiac arrest, Torsade de pointes, ventricular failure, ventricular hypokinesia
    • 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, 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: Tranaminases increased, alanine aminotransferase increased, aspartate aminotransferase increased, coagulation test abnormal, ammonia increased
    • Injury, Poisoning, and Procedural Complications*:...