According to information collected during clinical trials and spontaneous reports since marketing authorisation, the following undesirable effects may occur under treatment with naftidrofuryl.
The following definitions apply to the frequency terminology used hereafter:
very common ≥ 1/10
common ≥ 1/100, <1/10
uncommon ≥ 1/1,000, <1/100
rare ≥ 1/10,000, <1/1,000
very rare <1/10,000
frequency not known: cannot be estimated from the available data
Gastro-intestinal disorders:
Uncommon: Diarrhoea, nausea, vomiting and epigastric pain.
Frequency not known: In some patients who took the medicinal product without liquid before going to bed, the capsule being stuck in the throat led to local oesophagitis.
Renal and urinary disorders:
Very rare: Calcium oxalate kidney stones (see section 4.4).
Skin and subcutaneous tissue disorders:
Uncommon: Skin rash.
Hepatobiliary disorders:
Rare: Liver damage
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. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard