Hidrasec Adverse Reactions

The following adverse drug reactions listed as follows 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: Uncommon: rash, erythema.
Unknown: erythema multiforme, tongue oedema, face oedema, lip oedema, eyelid oedema, angioedema, urticaria, erythema nodosum, papular rash, prurigo, pruritus.
Serious skin reactions (including angioedema) have been reported in patients on racecadotril therapy. The incidence of these reactions is unknown but if they occur, racecadotril therapy must be discontinued and appropriate alternative therapy instituted. Patients should be aware not to take racecadotril again in these cases.