Montelukast

Common brands: Montelukast Sodium, Singulair, Albuterol, Acid Reducer, Ventolin Hfa

Top reporter: Ajanta Pharma Usa Inc.

Corticosteroid [EPC]Leukotriene Receptor Antagonist [EPC]Nonsteroidal Anti-inflammatory Drug [EPC]Proton Pump Inhibitor [EPC]Benzodiazepine [EPC]
80,773
Total Reports
39,831
Serious Reports
3,927
Death Reports
30
Reported Reactions
Death Report Ratio: Moderate (4.86%)

Patient Demographics

Male
23,805
Female
49,753

Reported Adverse Reactions (30)

Side effects reported in FDA adverse event reports for Montelukast.

# Reaction Reports % of Total
1 DYSPNOEA 7,947
7.5%
2 ASTHMA 7,658
7.3%
3 DRUG INEFFECTIVE 6,118
5.8%
4 FATIGUE 5,665
5.4%
5 HEADACHE 4,933
4.7%
6 COUGH 4,789
4.5%
7 NAUSEA 4,335
4.1%
8 OFF LABEL USE 4,049
3.8%
9 PNEUMONIA 4,005
3.8%
10 PAIN 3,744
3.6%
11 DIARRHOEA 3,534
3.4%
12 ANXIETY 3,523
3.3%
13 WHEEZING 3,388
3.2%
14 MALAISE 3,054
2.9%
15 DIZZINESS 3,006
2.9%
16 PRURITUS 2,995
2.8%
17 RASH 2,961
2.8%
18 VOMITING 2,802
2.7%
19 ARTHRALGIA 2,580
2.4%
20 PYREXIA 2,495
2.4%
21 PRODUCT DOSE OMISSION ISSUE 2,404
2.3%
22 INSOMNIA 2,371
2.3%
23 DEPRESSION 2,368
2.2%
24 URTICARIA 2,258
2.1%
25 CONDITION AGGRAVATED 2,205
2.1%
26 FALL 2,153
2.0%
27 PRODUCT USE IN UNAPPROVED INDICATION 2,106
2.0%
28 ASTHENIA 2,104
2.0%
29 HYPERTENSION 1,920
1.8%
30 WEIGHT DECREASED 1,857
1.8%

Important Disclaimer

FDA adverse event reports are submitted voluntarily and do not prove causation. A reported reaction does not mean the drug caused it. Drugs with more users naturally have more reports. Always consult your doctor or pharmacist before making medication decisions.