Montelukast Sodium — FDA Animal & Veterinary Adverse Event (ADE) Reports
Source: openFDA animalandveterinary/event.json, the FDA Center for Veterinary Medicine (CVM) adverse event report database. Data pulled 2026-07-22. Counts are report-level: one report may list multiple reactions and multiple animals, so figures are not additive and do not imply causation. Montelukast Sodium is a active ingredient.
Total reports
Montelukast Sodium: 13
Reports by species (top entries)
- Human 12
- Dog 1
Top reported reactions (VEDDRA terms, top entries)
- Accidental exposure 6
- Abdominal pain 2
- Dry mouth 2
- Nasal irritation 2
- Tingling sensation 2
- Vomiting 2
- Abnormal ECG 1
- Bad taste 1
- Breathlessness 1
- Burning sensation (skin) 1
Source JSON: pdf-raw/ade/ade_active_ingredients_2026-07-22_b29.json (openFDA animalandveterinary/event.json, pulled 2026-07-22).