Adverse reactions : תופעות לוואי

4.8    Undesirable effects
The most commonly reported adverse reactions during treatment are hypotension (mild, transient) and skin flushing, these events are attributed to histamine release. Very rarely, severe anaphylactoid or anaphylactic reactions have been reported in patients receiving atracurium in conjunction with one or more anaesthetic agents.
Adverse reactions are listed below by system organ class and frequency. Frequencies are defined as: very common > 1/10, common >1/100 and < 1/10, uncommon >1/1000 and < 1/100, rare >1/10,000 and < 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
Common                 Hypotension (mild, transient)#, Skin flushing# 
Respiratory, thoracic and mediastinal disorders
Uncommon              Bronchospasm#

Post-Marketing Data


Immune system disorders
Very rare                  Anaphylactic reaction, anaphylactoid reaction including shock, circulatory failure and cardiac arrest
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.

Events which have been attributed to histamine release are indicated by a hash (#)

Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Any suspected adverse events should be reported to the Ministry of Health according to the National Regulation by using an online form: http://sideeffects.health.gov.il
Additionally, you can also report to: www.perrigo-pharma.co.il