The following frequencies have been used in order to classify the occurrence of undesirable effects: 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; Very rare < 1/10,000; not known (cannot be estimated from the available data).
Incidence is listed as follows within each body system: Immune system disorders: Rare: hypersensitivity reactions including anaphylaxis have been reported in patients receiving remifentanil in conjunction with one or more anaesthetic agents.
Psychiatric disorders: Not known: drug dependence.
Nervous system disorders: Very common: skeletal muscle rigidity. Rare: sedation (during awakening after general anaesthesia). Not known: convulsions.
Cardiac disorders: Common: bradycardia. Rare: asystole/cardiac arrest with preceding bradycardia in patients treated with remifentanil in combination with other anaesthetics. Not known: atrioventricular block.
Vascular disorders: Very common: hypotension. Common: post-operatively occurring 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 pain. Not known: drug tolerance.
Discontinuation of treatment: Symptoms following withdrawal of remifentanil including tachycardia, hypertension and agitation have been reported infrequently upon abrupt cessation, particularly after prolonged administration of more than 3 days (see Precautions).
View ADR Monitoring Form