Hidonac Adverse Reactions

Summary of safety profile: Adverse reactions to acetylcysteine are mainly anaphylactoid, hypersensitivity in nature; urticaria, rash, pruritus, and dyspnoea are the most frequent features.
More serious anaphylactoid / hypersensitivity reactions have been reported where the patient develops angioedema, bronchospasm, tachycardia and hypotension.
Case reports of fatalities with intravenous acetylcysteine as antidote for paracetamol overdose have been reported very rarely.
Tabulated list of adverse reactions: The following adverse reactions were reported during post-marketing experience; their frequency is not known (cannot be estimated from the available data). (See Table 3.)

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Description of selected adverse reactions: In very rare cases, the occurrence of severe skin reactions such as Stevens-Johnson syndrome and Lyell's syndrome has been reported in temporal connection with the administration of acetylcysteine.
In most cases at least one co-suspect drug more probably involved in triggering the reported mucocutaneous syndrome could be identified.
Because of this, medical advice should be sought straight away if any new changes to the skin or mucous membranes occur, and acetylcysteine should be stopped immediately.
A decrease in platelet aggregation in the presence of N-acetylcysteine has been confirmed by various investigations. The clinical significance has not yet been established.
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. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system.