Ultiva Adverse Reactions

Adverse events are listed as follows by system organ class and frequency. Frequencies are defined as very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000) and very rare (<1/10,000).
Clinical Trial Data: The most common adverse events associated with ULTIVA are direct extensions of mu-opioid agonist pharmacology. The overall reporting incidence, as determined from all phases of controlled anaesthesia studies at recommended doses, is presented as follows.
These adverse events resolve within minutes of discontinuing or decreasing the rate of ULTIVA administration.
Nervous System Disorders: Very common: Skeletal muscle rigidity. Rare: Sedation (during recovery from general anaesthesia).
Cardiac Disorders: Common: Bradycardia.
Vascular Disorders: Very common: Hypotension. Common: Post-operative hypertension.
Respiratory, Thoracic and Mediastinal Disorders: Common: Acute respiratory depression, apnoea. Uncommon: Hypoxia.
Gastrointestinal Disorders: Very common: Nausea, vomiting. Uncommon: Constipation.
Skin and Subcutaneous Tissue Disorders: Common: Pruritus.
General Disorders and Administration Site Conditions: Common: Post-operative shivering. Uncommon: Post-operative aches.
Post-Marketing Data: The following adverse events and reporting frequencies have been determined from post-marketing reporting.
Immune System Disorders: Rare: Allergic reactions including anaphylaxis have been reported in patients receiving ULTIVA in conjunction with one or more anaesthetic agents.
Cardiac Disorders: Rare: Asystole/cardiac arrest, usually preceded by bradycardia, has been reported in patients receiving ULTIVA in conjunction with other anaesthetic agents.