Exelfos Adverse Reactions

The most common adverse reactions following the single-dose administration of fosfomycin trometamol involve the gastrointestinal tract, mainly diarrhoea. These events are usually self-limited in duration and resolve spontaneously.
The following table displays ADRs that have been reported with the use of fosfomycin from either clinical-trial or post-marketing experiences.
The displayed frequency categories use the following convention: Very common (1/10); Common (1/100 to < 1/10); Uncommon (1/1000 to < 1/100); Rare (1/10000 to < 1/1000); Very rare (< 1/10000); Not known (cannot be estimated from the available data).
Blood and lymphatic system disorders: Not known: slight increase of eosinophils and platelets count, with mild petechiae.
Rare: aplastic anemia.
Immune system disorders: Rare: hypersensitivity, exanthema, urticaria and angioedema, and severe anaphylactic reactions including anaphylactic shock (see Precautions).
Gastrointestinal disorders: Common: vomiting, diarrhoea, dyspepsia, nausea.
Hepatobiliary disorders: Not known: transient increase of plasmatic alkaline phosphates and aminotransferases.
Others: Not known: visual disturbances, lack of appetite, phlebitis, dyspnea, bronchospasm and cephalea.
Rare: superinfections from resistant bacteria.
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.