The following CIOMS frequency rating is used, when applicable: 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).
Immune System Disorders
There have been reports of anaphylactic reactions, allergic skin eruption and fixed drug eruption.
Gastrointestinal disorders
There have been reports of diarrhoea, nausea, epigastric discomfort and gastrointestinal bleeding occurring during treatment with Carbocisteine.
Frequency not known: vomiting, gastrointestinal bleeding.
Skin and subcutaneous tissue disorders
There have been reports of skin rashes and allergic skin eruptions. Isolated cases of dermatitis bullous such as Stevens– Johnson syndrome and erythema multiforme have also been reported.
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 Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.