HIGH-VOLUME · SEX-BALANCED
montelukast Side Effects
montelukast (also sold as Singulair) is HIGH-VOLUME in this FAERS book #95 of 524 by FAERS report count. Signature opener: SEX-BALANCED - 68% of sex-coded reports are female (48,242 F / 23,173 M).
Data updated 2026-05-15
- 78,359
- FAERS reports
FAERS voluntary reports, 2002 to 2025. High volume tracks exposure and reporting culture; see methodology for de-dup rules.
montelukast reporting skew - 68% of sex-coded reports are female (48,242 F / 23,173 M). Volume band HIGH-VOLUME #95 of 524 by FAERS report count; caseload CASELOAD.
High-report extract for montelukast (Singulair): 78,359 FAERS rows (2002-2025). Top named reactions: DYSPNOEA, ASTHMA, FATIGUE. Outcome stamps DEATH-MARKED · HOSP-MID · SEX-BALANCED. FAERS is voluntary signal detection, not incidence.
Counts from the openFDA FAERS extract (2002–2025). Stamps CASELOAD · DEATH-MARKED · HOSP-MID · SEX-BALANCED.
DYSPNOEA leads 7,723 of 78,359 reports
Who reports · age peak 45-64 (SEX-BALANCED)
Sex coding · SEX-BALANCED
Age peak 45-64 (18,237 reports)
FAERS filings rising toward 2025
Reactions in Death Reports
Death appears on 3,777 reports (4.8% - MARKED). Reactions below co-occur in those rows only.
| Reaction | Reports |
|---|---|
| DEATH | 1,714 |
| PNEUMONIA | 290 |
| ASTHMA | 258 |
| DYSPNOEA | 253 |
| FATIGUE | 221 |
| PYREXIA | 215 |
| COMPLETED SUICIDE | 214 |
| HEADACHE | 177 |
| PAIN | 167 |
| ACUTE KIDNEY INJURY | 160 |
| NAUSEA | 153 |
| CONDITION AGGRAVATED | 151 |
| HYPERTENSION | 143 |
| CARDIAC ARREST | 138 |
| FLUID RETENTION | 134 |
| RESPIRATORY FAILURE | 134 |
| ERYTHEMA | 133 |
| CONSTIPATION | 127 |
Reactions in Hospitalization Reports
Hospitalization mid-share (21,518, 27.5%). Co-reported reactions:
| Reaction | Reports |
|---|---|
| DYSPNOEA | 3,501 |
| ASTHMA | 3,138 |
| PNEUMONIA | 2,487 |
| COUGH | 1,699 |
| WHEEZING | 1,572 |
| FATIGUE | 1,556 |
| HEADACHE | 1,311 |
| NAUSEA | 1,266 |
| PYREXIA | 1,149 |
| FALL | 1,136 |
| DIARRHOEA | 1,105 |
| MALAISE | 1,085 |
| VOMITING | 1,019 |
| PAIN | 1,015 |
| THERAPEUTIC PRODUCT EFFECT INCOMPLETE | 945 |
| ASTHENIA | 901 |
| HOSPITALISATION | 863 |
| DIZZINESS | 854 |
How to read montelukast FAERS figures (CASELOAD · DEATH-MARKED · HOSP-MID)
FAERS holds 78,359 voluntary reports linked to montelukast (Singulair), 2002-2025. Death is listed on 3,777 (4.8%). Hospitalization appears on 21,518 (27.5%). Top co-reported indication: Product Used For Unknown Indication.
CASELOAD books overweight common drugs and loud reporting cultures; SEX-BALANCED is the page opener, not a per-patient risk.
Read with montelukast
Peers ranked by ABS(total_reports), then an ABS(death_share) pole; guide hop follows DEATH-MARKED · HOSP-MID stamps.
ABS(total_reports) peer at 79,748 FAERS cases (Δ 1,389 heavier vs montelukast); DEATH-MARKED · HOSP-MID · FEMALE-LED vs this page's CASELOAD · DEATH-MARKED · HOSP-MID · SEX-BALANCED.
ABS(total_reports) peer at 76,270 FAERS cases (Δ 2,089 lighter vs montelukast); DEATH-HEAVY · HOSP-MID · FEMALE-LED vs this page's CASELOAD · DEATH-MARKED · HOSP-MID · SEX-BALANCED.
ABS(total_reports) peer at 75,912 FAERS cases (Δ 2,447 lighter vs montelukast); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's CASELOAD · DEATH-MARKED · HOSP-MID · SEX-BALANCED.
ABS(total_reports) peer at 82,165 FAERS cases (Δ 3,806 heavier vs montelukast); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's CASELOAD · DEATH-MARKED · HOSP-MID · SEX-BALANCED.
ABS(death_share) pole at 62.1% death-mentioned reports (Δ 57.3 pp vs montelukast's DEATH-MARKED): CASELOAD · HOSP-MID.
montelukast sits in CASELOAD; high report volume tracks exposure and reporting culture more than per-patient risk. Methodology states the de-dup rules.