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R
montelukast
219ms
Level 1
✓ What this shows
- • Reported adverse events from FDA FAERS
- • Descriptive statistics from a locked corpus
- • Data verified with cryptographic hashes
✗ What this is NOT
- • Not medical advice or recommendations
- • Not proof of causality
- • Not a complete safety profile
About this substance
1. INDICATIONS AND USAGE Montelukast sodium tablets are a leukotriene receptor antagonist indicated for: • Prophylaxis and chronic treatment of asthma in patients 2 years of age and older (1.1). • Acute prevention of exercise-induced bronchoconstriction (EIB) in patients 15 years of age and older (1...
Known as: Montelukast Sodium
Route: ORAL
Source: OpenFDA Drug Labels · Reference only · Not medical advice
500
Events in Corpus
v20260131-01
78,995
Total in FDA
77%
Serious Reports
21
Fatal Outcomes
Seriousness
Serious
383
Non-Serious
117
Sex Distribution
Male
144
Female
341
Unknown
15
Age Distribution
0-17
78
18-40
71
41-64
129
65-84
122
85+
9
Unknown
91
Outcomes
Recovered/Resolved
381
Recovering/Resolving
180
Not Recovered/Not Resolved
330
Recovered with Sequelae
10
Fatal
21
Unknown
976
Top Reported Reactions (click to view reports)
Verification Data
Corpus Version: v20260131-01
Root Hash: ec5727564d1ed19be5b08b26d3866f446b12d3d388f5a8cd713332c6d97ad264
Stats Hash: N/A
EVE Decision ID: EVE-MED-20260402-923fe8
This output reports adverse events from FDA FAERS. It does not constitute medical advice.
Molecular Structure (reference)
Structural visualization for identification only.
This visualization shows the molecular structure for identification purposes only. It does not represent pharmacological effect, safety, or clinical relevance.
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