Safety and Tolerability
In post-marketing study conducted in over 4000 patients by the innovator, the most frequently observed (0.1 to 5%) adverse reactions were elevated levels of liver enzymes such as ALT, AST, ALP, LDH and γ-GTP, nausea, loss of appetite, stomach discomfort, abdominal pain, diarrhea, constipation, dry mouth, taste disturbance, drowsiness, headache, dizziness, palpitations and malaise. Less than 0.1% of patients experienced vomiting, thrombocytopenia, epistaxis, bleeding tendency, insomnia, tremor, numbness, hot flushes and edema. All the adverse reactions reported were of mild to moderate severity, and resolved when the drug was discontinued.
In clinical studies with Seratrodast, no significant difference was observed in the incidence of adverse events when compared with Montelukast. Global assessment towards the therapy with Seratrodast was deemed as “satisfactory-to-excellent” by the investigators. No difference in overall drug compliance was observed with Seratrodast when compared with Montelukast (99.02% vs. 98.06%).
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