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FDA ADE reports for Montelukast Sodium

ade_montelukast_adverse_events

ade en 2026-07-22

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).

Sources

FDA ADE reports for Montelukast Sodium (active ingredient) — total reports, species & reaction breakdown
Source document: FDA FAERS / openFDA Animal & Veterinary Event Reports
US FDA Center for Veterinary Medicine (openFDA animal & veterinary event database)retrieved 2026-07-22

Verification file: pdf-raw/ade/ade_active_ingredients_2026-07-22_b29.json

Link points to the issuing authority's site; a direct document link is still being verified.

Machine access

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Raw JSON ↗ llm.txt OpenAPI