Fluimucil Adverse Reactions

Syrup: Summary of the safety profile: The adverse effects most commonly associated with the oral administration of N-acetylcysteine are gastrointestinal. Hypersensitivity reactions including anaphylactic shock, anaphylactic/anaphylactoid reactions, bronchospasm, angioedema, rash and pruritus have been reported less frequently.
Summary table of undesirable effects: The table as follows lists the undesirable effects recorded according to system/organ class and frequency: very common (≥1/10), common (≥1/100 - <1/10), uncommon (≥1/1,000 - <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 group, undesirable effects are presented in order of decreasing seriousness. (See table.)

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There is also a risk of worsening of bronchial congestion, especially in infants and in certain patients incapable of effective expectoration.
Description of some adverse reactions: Severe skin reactions such as Stevens-Johnson syndrome and Lyell's syndrome have been reported in very rare cases with a chronological connection with the use of acetylcysteine. In most cases, at least one other suspect medicinal product that was more likely to have been the cause of the mucocutaneous syndrome could be identified. In the event of the recent onset of cutaneous or mucosal reactions, medical advice should be sought and the treatment with acetylcysteine should be discontinued immediately.
A decrease in platelet aggregation in the presence of acetylcysteine has been confirmed in various studies. The clinical significance of this has not yet been determined.