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Ultane Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Ultane (sevoflurane) Volatile Liquid For Inhalation is used to induce and maintain general anesthesia in adult and pediatric patients during surgery. It is an anesthetic drug. This medication is available in generic form. Common side effects include drowsiness and dizziness. Expect these effects. Notify your doctor if you develop: anxiety, chills, breathing trouble, unusual change in amount of urine, seizures, muscle stiffness, fast/irregular heartbeat, stomach/abdominal pain, fatigue, yellowing eyes or skin, dark urine.
The administration of general anesthesia such as Ultane must be individualized based on the patient's response. Ultane may interact with other drugs. Tell your doctor all medications and supplements you use. During pregnancy, Ultane should be used only if prescribed. Consult your doctor before breastfeeding.
Our Ultane (sevoflurane) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Ultane FDA Prescribing Information: Side Effects
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, 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 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.
Adverse Events During the Induction Period (from Onset of Anesthesia by Mask Induction to Surgical Incision) Incidence > 1%
Adult Patients (N = 118)
Laryngospasm 8%, Airway obstruction 8%, Breathholding 5%, Cough Increased 5%
Pediatric Patients (N = 507)
Tachycardia 6%, Hypotension 4%
Breathholding 5%, Cough Increased 5%, Laryngospasm 3%, Apnea 2%
Increased salivation 2%
Adverse Events During Maintenance and Emergence Periods, Incidence > 1 % (N = 2906)
Body as a whole
Fever 1%, Shivering 6%, Hypothermia 1%, Movement 1%, Headache 1%
Hypotension 11%, Hypertension 2%, Bradycardia 5%, Tachycardia 2%
Somnolence 9%, Agitation 9%, Dizziness 4%, Increased salivation 4%
Nausea 25%, Vomiting 18%
Cough increased 11%, Breathholding 2%, Laryngospasm 2%
Adverse Events, All Patients in Clinical Trials (N = 2906), All Anesthetic Periods, Incidence < 1% (Reported in 3 or More Patients)
Body as a whole
Arrhythmia, Ventricular Extrasystoles, Supraventricular Extrasystoles, Complete AV Block, Bigeminy, Hemorrhage, Inverted T Wave, Atrial Fibrillation, Atrial Arrhythmia, Second Degree AV Block, Syncope, S-T Depressed
Metabolism and Nutrition
Hemic and Lymphatic System
Skin and Special Senses
Urination Impaired, Urine Abnormality, Urinary Retention, Oliguria
See WARNINGS for information regarding malignant hyperthermia.
Post-Marketing Adverse Events
The following adverse events have been identified during post-approval use of Ultane (sevoflurane USP). Due to the spontaneous nature of these reports, the actual incidence and relationship of Ultane to these events cannot be established with certainty.
Seizures - Post-marketing reports indicate that sevoflurane 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 EEC. 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 induction, during emergence, and during post-operative recovery up to a day following anesthesia.
- 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 (see PRECAUTIONS).
- Hepatic necrosis
- Hepatic failure
- Malignant hyperthermia (see CONTRAINDICATIONS and WARNINGS)
- Allergic reactions, such as rash, urticaria, pruritus, bronchospasm, anaphylactic or anaphylactoid reactions (see CONTRAINDICATIONS)
- Rare reports of hypersensitivity (including contact dermatitis, rash, dyspnoea, wheezing, chest discomfort, swelling face, or anaphylactic reaction) have been received, particularly in association with long-term occupational exposure to inhaled anesthetic agents, including sevoflurane (see Occupational Caution).
- Transient elevations in glucose, liver function tests, and white blood cell count may occur as with use of other anesthetic agents.
Read the entire FDA prescribing information for Ultane (Sevoflurane) »
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