The frequencies of adverse events are ranked according to the following: Very common (>1/10); common (>1/100, <1/10); uncommon (>1/1000, <1/100); rare (>1/10,000, <1/1000); very rare (<1/10,000), including isolated reports.
Gastrointestinal Disorders: Common: Digestive, gastric or intestinal disorders (abdominal pain, nausea, vomiting, diarrhoea and flatulence) moderate in severity. Very Rare: Cases of pancreatitis have been reported during treatment with fenofibrate.
Hepatobiliary Disorders: Common: Moderately elevated levels of serum transaminases. Uncommon: Development of gallstones. Very Rare: Episodes of hepatitis. When symptoms (eg, jaundice, pruritus) indicative of hepatitis occur, laboratory tests are to be conducted for verification and fenofibrate discontinued, if applicable.
Skin and Subcutaneous Tissue Disorders: Uncommon: Rashes, pruritus, urticaria or photosensitivity reactions. Rare: Alopecia. Very Rare: Cutaneous photosensitivity with erythema, vesiculation or nodulation on parts of the skin exposed to sunlight or artificial UV light (eg, sunlamp) in individual cases (even after many months of uncomplicated use).
Musculoskeletal, Connective Tissue and Bone Disorders: Rare: Diffuse myalgia, myositis, muscular cramps and weakness. Very Rare: Rhabdomyolysis.
Blood and Lymphatic System Disorders: Rare: Decrease in hemoglobin and leukocytes.
Nervous System Disorders: Rare: Sexual asthenia, headache.
Respiratory, Thoracic and Mediastinal Disorders: Very Rare: Interstitial pneumopathies.
Investigation: Uncommon: Increases in serum creatinine and urea.