In the literature the most frequently reported adverse events attributed to I.V. acetylcysteine administration were rash, urticaria, and pruritus. The frequency of adverse events has been reported to be between 0.2% and 20.8%, and they most commonly occur during the initial loading dose of acetylcysteine.

The incidence of drug-related adverse events occurring within the first 2 hours following acetylcysteine administration reported in a randomized study (Infusion Rate Study) in patients with acetaminophen poisoning is presented in Table 5 by preferred term. In this study patients were randomized to a 15-minute or a 60-minute loading dose regimen.

Table 1 Incidence of Drug-Related Adverse Events Occurring Within the First 2 Hours Following Study Drug Administration by Preferred Term: Safety Study

Adverse events summarized by the Rocky Mountain Poison and Drug Center from 76 published articles in which I.V. acetylcysteine was administered (acetaminophen overdose and other published uses) are listed with an incidence greater than 1% in Table 2. Charcoal, naloxone, and benzodiazepines were administered concomitantly in several of these studies.

Data on file: Systematic Analysis of Medical Literature Regarding Safety of I.V. N-acetylcysteine, Rocky Mountain Poison & Drug Center, Denver Health; 27 December 2001.

Drug stability and safety of acetylcysteine when mixed with other drugs have not been established.

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