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).
Severe cutaneous adverse reactions (SCARs), including drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported in association with racecadotril treatment (see Precautions).
Skin and subcutaneous tissue disorders: Uncommon: rash, erythema. Unknown: erythema multiforme, tongue oedema, face oedema, lip oedema, eyelid oedema, angioedema, urticaria, erythema nodosum, rash papular, prurigo, pruritus, drug reaction with eosinophilia and systemic symptoms (DRESS).
Immune system disorders: Unknown: anaphylactic shock.
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.
Capsule: Nervous system disorders: Common: headache.
Skin and subcutaneous tissue disorders: Unknown: toxic skin eruption.
Paediatric population: In infants or children treated with racecadotril, the occurrence of tonsillitis has been reported as an uncommon adverse event. There are specific formulations for these age groups.
Granules for oral suspension: Infections and infestations: Uncommon: tonsillitis.