Fluimucil Adverse Reactions

Summary of the safety profile: The most frequent adverse events associated with the oral administration of acetylcysteine are gastrointestinal in nature. Hypersensitivity reactions including anaphylactic shock, anaphylactic/anaphylactoid reaction, bronchospasm, angioedema, rash and pruritus have been reported less frequently.
Tabulated list of adverse reactions: In the table as follows, adverse reactions are listed by system organ class and frequency (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) and not known (cannot be estimated from the available data).
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Adverse reactions reported after use of N-acetylcysteine oral formulations are shown as follows: See table.

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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.
Seek immediate medical advice if any new changes to the skin or mucous membrane occur. Acetylcysteine must be discontinued immediately.
A decrease in platelet aggregation in the presence of 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 authorization 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.