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Ultane (Sevoflurane Inhalation) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

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)

Cardiovascular

Bradycardia 5%, Hypotension 4%, Tachycardia 2%

Nervous System

Agitation 7%

Respiratory System

Laryngospasm 8%, Airway obstruction 8%, Breathholding 5%, Cough Increased 5%

Pediatric Patients (N = 507)

Cardiovascular

Tachycardia 6%, Hypotension 4%

Nervous System

Agitation 15%

Respiratory System

Breathholding 5%, Cough Increased 5%, Laryngospasm 3%, Apnea 2%

Digestive System

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%

Cardiovascular

Hypotension 11%, Hypertension 2%, Bradycardia 5%, Tachycardia 2%

Nervous System

Somnolence 9%, Agitation 9%, Dizziness 4%, Increased salivation 4%

Digestive System

Nausea 25%, Vomiting 18%

Respiratory System

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

Asthenia, Pain

Cardiovascular

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

Nervous System

Crying, Nervousness, Confusion, Hypertonia, Dry Mouth, Insomnia

Respiratory System

Sputum Increased, Apnea, Hypoxia, Wheezing, Bronchospasm, Hyperventilation, Pharyngitis, Hiccup, Hypoventilation, Dyspnea, Stridor

Metabolism and Nutrition

Increases in LDH, AST, ALT, BUN, Alkaline Phosphatase, Creatinine, Bilirubinemia, Glycosuria, Fluorosis, Albuminuria, Hypophosphatemia, Acidosis, Hyperglycemia

Hemic and Lymphatic System

Leucocytosis, Thrombocytopenia

Skin and Special Senses

Amblyopia, Pruritus, Taste Perversion, Rash, Conjunctivitis

Urogenital

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.

CNS

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 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 induction, during emergence, and during post-operative recovery up to a day following anesthesia.

Cardiac

Cardiac arrest

Hepatic

  • 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

Other

  • Malignant hyperthermia (see CONTRAINDICATIONS and WARNINGS)
  • Allergic reactions, such as rash, urticaria, pruritus, bronchospasm, anaphylactic or anaphylactoid reactions (see CONTRAINDICATIONS)
  • Reports of hypersensitivity (including contact dermatitis, rash, dyspnea, 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).

Laboratory Findings

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


REPORTS OF SUSPECTED ULTANE SIDE EFFECTS / ADVERSE REACTIONS

Below is a sample of reports where side effects / adverse reactions may be related to Ultane. The information is not vetted and should not be considered as verified clinical evidence.

Possible Ultane side effects / adverse reactions in 70 year old female

Reported by a physician from United States on 2012-02-20

Patient: 70 year old female

Reactions: Anaesthetic Complication Neurological, Confusional State, Amnesia, Aggression

Adverse event resulted in: hospitalization

Suspect drug(s):
Ultane



Possible Ultane side effects / adverse reactions in 10 month old female

Reported by a physician from South Africa on 2012-08-22

Patient: 10 month old female weighing 7.8 kg (17.2 pounds)

Reactions: Metabolic Acidosis, Body Temperature Increased, Heart Rate Increased, Hyperthermia Malignant

Suspect drug(s):
Ultane



See index of all Ultane side effect reports >>

Drug label data at the top of this Page last updated: 2014-03-21

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