Rasec Adverse Reactions

Data from clinical acute diarrhoea studies are available on 860 paediatric patients treated with racecadotril, and 441 treated with placebo. The following adverse drug reactions listed below have occurred with racecadotril more often than with placebo or have been reported during post-marketing surveillance. The frequency of adverse reactions is defined using the following convention: 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).
Infections and infestations: Uncommon: tonsillitis.
Skin and subcutaneous tissue disorders (see Precautions): Uncommon: rash, erythema.
Unknown: erythema multiforme, tongue oedema, lace oedema, lip oedema, eyelid oedema, angioedema, urticaria, erythema nodosum, rash papular, prurigo, pruritus.
Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorization of the medicinal product allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions.