Parmodia Adverse Reactions

Summary of the safety profile: In clinical studies conducted by the time of approval in Japan, adverse reactions were observed in 206 of 1,418 patients (14.5%). The most commonly reported adverse reactions included cholelithiasis observed in 20 patients (1.4%), diabetes mellitus in 20 patients (1.4%), and blood creatine phosphokinase increased in 12 patients (0.8%).
Summary of adverse reactions: Clinical studies experience: Adverse reactions and frequencies observed in clinical studies conducted by the time of approval in Japan are listed as follows. If any of the following adverse reactions or similar is observed, the patients should be treated appropriately according to the symptoms. (See Table 15.)

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Post-marketing experience: The following adverse reactions have been reported, but the incidence of events cannot be calculated and are unknown because these events include the events reported as spontaneous reports. (See Table 16.)

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Description of adverse events from the PROMINENT study: Venous thromboembolism: In the PROMINENT study, a randomized placebo-controlled trial performed in 10,538 patients with type 2 diabetes, moderate hypertriglyceridemia and low levels of high-density lipoprotein cholesterol, higher incidences of pulmonary embolism and deep vein thrombosis were observed in the pemafibrate group compared to the placebo group [0.7% (37/5,264) in the pemafibrate group versus 0.3% (16/5,274) in the placebo group, 0.7% (36/5,264) in the pemafibrate group versus 0.2% (13/5,274) in the placebo group, respectively].
No events of pulmonary embolism or deep vein thrombosis were assessed as related to pemafibrate by the investigator.