Fluifort Adverse Reactions

The experience derived from the commercialization of Fluifort indicates that the occurrence of undesirable effects is a very rare event. Based on the estimate of exposed patients, the spontaneous reporting of adverse reactions has been less than 1 patient out of 1 million exposed patients. In most cases, the symptoms were transient and resolved after therapy discontinuation and, in some cases, after a specific pharmacological treatment.
The adverse reactions reported with Fluifort, which are all very rare (incidence <1/10,000), are the following: Skin and adnexa: skin rash, urticaria, erythema, exanthema, exanthema/erythema bullosum, itching, angioedema, dermatitis.
Digestive system: abdominal pain, nausea, vomiting, diarrhoea.
Nervous system: vertigo.
Cardiovascular system: flushing.
Respiratory system: dyspnoea.
One single case of both hypogeusia and parosmia has been reported in one patient treated with doses higher than those recommended.
The rarest adverse reactions of a severe grade (only three cases reported) include only cases of skin reactions (urticaria, erythema and/or exanthema, also bullosum).
Bronchial obstruction may occur after oral and rectal use of mucolytic agents (unknown frequency).
The medicine contains methyl-p-hydroxybenzoate, known for the possibility of causing urticaria. In general, the para-hydroxybenzoates may cause delayed reactions, such as contact dermatitis, and rarely immediate reactions with manifestations of urticaria and bronchospasm.