ACC Sandoz Adverse Reactions

The evaluation of undesirable effects is based on the following information on frequencies: 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); Not known (cannot be estimated from the available data). (See table.)

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In very rare cases, severe skin reactions such as Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported in temporal association with the use of acetylcysteine. In most of these reported cases, at least one additional drug that could potentially have intensified the described mucocutaneous effects was being taken at the same time.
If skin or mucous membrane abnormalities develop, medical advice should therefore immediately be sought and the use of acetylcysteine discontinued.
In addition, the occurrence of haemorrhages in association with the administration of acetylcysteine has very rarely been reported, partially with hypersensitivity reactions. A decreased blood platelet aggregation in the presence of acetylcysteine has been confirmed by various studies. The clinical relevance has not yet been clarified to date.
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 listed.