Atracurium Besylate Side Effects

ADVERSE REACTIONS Observed in Controlled Clinical Studies Atracurium was well tolerated and produced few adverse reactions during extensive clinical trials.

Most adverse reactions were suggestive of histamine release.

In studies including 875 patients, atracurium was discontinued in only one patient (who required treatment for bronchial secretions) and six other patients required treatment for adverse reactions attributable to atracurium (wheezing in one, hypotension in five).

Of the five patients who required treatment for hypotension, three had a history of significant cardiovascular disease.

The overall incidence rate for clinically important adverse reactions, therefore, was 7/875 or 0.8%.

Table 1 includes all adverse reactions reported attributable to atracurium during clinical trials with 875 patients.

Table 1: Percent of Patients Reporting Adverse Reactions * Includes the recommended initial dosage range for most patients.

Adverse Reaction Initial Atracurium Dose (mg/kg) 0.00 to 0.30 (n = 485) 0.31 to 0.50 * (n = 366) > 0.60 (n = 24) Total (n = 875) Skin Flush 1% 8.7% 29.2% 5% Erythema 0.6% 0.5% 0% 0.6% Itching 0.4% 0% 0% 0.2% Wheezing/Bronchial Secretions 0.2% 0.3% 0% 0.2% Hives 0.2% 0% 0% 0.1% Most adverse reactions were of little clinical significance unless they were associated with significant hemodynamic changes.

Table 2 summarizes the incidences of substantial vital sign changes noted during atracurium clinical trials with 530 patients, without cardiovascular disease, in whom these parameters were assessed.

Table 2: Percent of Patients Showing >30% Vital Sign Changes Following Administration of Atracurium * Includes the recommended initial dosage range for most patients.