Rocuronium Kabi Adverse Reactions

The frequency of undesirable effects is classified into the following categories:
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: Frequency cannot be estimated from the available data.
The most common undesirable effects are pain/reaction around injection site, changes in vital functions and prolonged neuromuscular block.
Immune system disorders: Very rare: Anaphylactic reaction e.g. anaphylactic shock; Anaphylactoid reaction*; Hypersensitivity.
Nervous system disorders: Very rare: Paralysis.
Cardiac disorders: Very rare: Tachycardia.
Vascular disorders: Very rare: Hypotension; Circulatory collapse and shock.
Respiratory, thoracic, and mediastinal disorders: Very rare: Bronchospasm.
Not known: Apnoea, Respiratory failure.
Skin and subcutaneous tissue disorders: Very rare: Rash, erythematous rash; Angioedema, Urticaria; Itching; Exanthema.
Musculoskeletal disorders: Not known: skeletal muscle weakness; steroid myopathy* (see Precautions).
General disorders and administration site conditions: Very common: Injection site pain/reaction*.
Investigations: Very rare: Increased histamine level*.
Injury, poisoning and procedural complication: Very rare: prolonged neuromuscular block*.
*Additional information on adverse reactions: Anaphylactic reaction: Severe anaphylactic reactions to neuromuscular blocking agents have been reported to be fatal in some cases. Due to the possible severity of these reactions, one should always assume that they may occur and take the necessary precautions.
Local injection site reactions: During rapid sequence induction of anaesthesia, pain on injection has been reported, especially when the patient has not yet completely lost consciousness and particularly when propofol is used as the induction agent. In clinical studies, pain on injection has been noted in 16 % of the patients who underwent rapid sequence induction of anaesthesia with propofol and in less than 0.5 % of the patients who underwent rapid sequence induction of anaesthesia with fentanyl and thiopental.
Increased histamine level: Since neuromuscular blocking agents are known to be capable of inducing histamine release both locally and systemically, the possible occurrence of itching and erythematous reaction at the site of injection and/or generalised histaminoid (anaphylactoid) reactions such as bronchospasm and cardiovascular changes e.g. hypotension and tachycardia should always be taken into consideration when administering these drugs. Rash, exanthema, urticaria, bronchospasm and hypotension have been reported very rarely in patients given rocuronium bromide.
In clinical studies only a slight increase in mean plasma histamine level has been observed following rapid bolus administration of 0.3 - 0.9 mg rocuronium bromide per kg body weight.
Prolonged neuromuscular block: The most frequent adverse reaction to non-depolarizing blocking agents as a class consists of an extension of the agent's pharmacological action beyond the time period needed. This may vary from skeletal muscle weakness to profound and prolonged skeletal muscle paralysis resulting in respiratory insufficiency or apnoea.
Paediatric patients: A meta-analysis of 11 clinical studies in paediatric patients (n=704) with rocuronium bromide (up to 1 mg/kg) showed that tachycardia was identified as adverse drug reaction with a frequency of 1.4 %.