Tracrium Adverse Reactions

Adverse reactions 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 (≥ 1/1000 to < 1/100), rare (≥ 1/10,000 to < 1/1000), very rare (< 1/10,000). Very common, common and uncommon frequencies were determined from clinical trial data. Rare and very rare frequencies were generally derived from spontaneous data. The frequency classification "Not known" has been applied to those reactions where a frequency could not be estimated from the available data.
Clinical Trial Data: Vascular Disorders: Events which have been attributed to histamine release are indicated by a hash (#).
Common: Hypotension (mild, transient)#, Skin flushing#.
Respiratory, thoracic and mediastinal disorders: Events which have been attributed to histamine release are indicated by a hash (#).
Uncommon: Bronchospasm#.
Post-Marketing Data: Immune system disorders: Very rare: Anaphylactic reaction, anaphylactoid reaction.
Very rarely, severe anaphylactoid or anaphylactic reactions have been reported in patients receiving atracurium in conjunction with one or more anaesthetic agents.
Nervous system disorder: Not known: Seizures.
There have been reports of seizures in ICU patients who have been receiving atracurium concurrently with several other agents. These patients usually had one or more medical conditions predisposing to seizures (e.g. cranial trauma, cerebral oedema, viral encephalitis, hypoxic encephalopathy, uraemia). A causal relationship to laudanosine has not been established. In clinical trials, there appears to be no correlation between plasma laudanosine concentration and the occurrence of seizures.
Skin and subcutaneous tissue disorders: Rare: Urticaria.
Musculoskeletal and connective tissue disorders: Not known: Myopathy, muscle weakness.
There have been some reports of muscle weakness and/or myopathy following prolonged use of muscle relaxants in severely ill patients in the ICU. Most patients were receiving concomitant corticosteroids. These events have been seen infrequently in association with atracurium and a causal relationship has not been established.