Adverse Reaction Profile of KOSELUGO

The most common side effects of KOSELUGO include vomiting, rash, abdominal pain, diarrhea, nausea, dry skin, fatigue, musculoskeletal pain, fever, acneiform rash, stomatitis, headache, paronychia, and pruritus, with many occurring in over 40% of patients. Serious adverse events such as cardiomyopathy, ocular toxicity, increased creatine phosphokinase, and risk of bleeding have also been reported. Laboratory abnormalities include elevated creatine phosphokinase, liver enzymes, and decreased blood counts. Permanent discontinuation due to adverse reactions occurred in 12% of patients. Long-term safety data and effects in populations outside the studied group are not specified in the description.