|The overall safety profile of bezafibrate is based on a combination of clinical study data and post-marketing experience. The frequency of adverse drug reactions (ADRs) according to MedDRA System Organ Class is displayed in the table below. Frequency of reporting: Common (≥ 1/100 and <1/10), Uncommon ( ≥ 1/1,000 and <1/100), Rare ( ≥ 1/10,000 and <1/1000), Very rare (<1/10,000). |
Blood and lymphatic system disorders:Very rare: Pancytopenia, thrombocytopenic purpura.
Immune system disorders:Uncommon: Hypersensitivity reactions including anaphylactic reactions.
Metabolism and nutrition disorders:Common: Decreased appetite.
Nervous system disorders:Uncommon: Dizziness, headache.Rare: Peripheral neuropathy, paraesthesia.
Psychiatric disorders: Rare: Depression, insomnia.
Gastrointestinal disorders: Common: Gastrointestinal disorders.Uncommon: Abdominal pain, constipation, dyspepsia, abdominal distension, diarrhoea, nausea.Rare: PancreatitisHepatobiliary disorders: Uncommon: Cholestasis. Very rare: Cholelithiasis.
Skin and subcutaneous tissue disorders:Uncommon: Pruritus, urticaria, photosensitivity reaction, alopecia, rash. Very rare: Erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis.
Musculoskeletal and connective tissue disorders: Uncommon: Muscular weakness, myalgia, muscle cramp. Very rare: Rhabdomyolysis.
Renal and urinary disorders: Uncommon: Acute renal failure.
Reproductive system and breast disorders: Uncommon: Erectile dysfunction NOS.
Respiratory, thoracic and mediastinal disorders: Very rare: Interstitial lung disease.
Investigations: Uncommon: Increased blood creatinine phosphokinase, blood creatinine increased, decreased gamma-glutamyl transferase and in parallel alkaline phosphataseVery rare: Haemoglobin decreased, platelet increased, white blood cell count decreased, gamma-glutamyl transferase increased, transaminase increased.