Montelukast Sodium side effects: what 121,015 FDA adverse event reports show
Drug class
Not stated in label
Who reports
121,015 reports · 60% serious · 4,918 with death outcome · 72% female
Used for
Montelukast sodium tablets are a leukotriene receptor antagonist indicated for: • Prophylaxis and chronic treatment of asthma in patients 15 years of age and older (1.1). • Acute prevention of exercise-induced bronchoconstriction (EIB) in patients 15 years of age and older (1.2).
What it is
Montelukast is an aliphatic sulfide, a monocarboxylic acid and a member of quinolines. It has a role as an anti-arrhythmia drug, a leukotriene antagonist and an anti-asthmatic drug.
Boxed warning
SERIOUS NEUROPSYCHIATRIC EVENTS Serious neuropsychiatric (NP) events have been reported with the use of montelukast sodium. The types of events reported were highly variable, and included, but were not limited to, agitation, aggression, depression, sleep disturbances, suicidal thoughts and behavior (including suicide).
Causality screen of the 40 strongest signals
What the badges mean
- Labeled — boxed warning The term (or its clinical synonym) appears in the FDA boxed warning: causality is regulator-recognised and considered serious.
- Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
- Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
- Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
- Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
- Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.
Strongest disproportionality signals
Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only (and, for the 300 most-reported drugs, adjusted for age band), and flags pairs whose reports are unusually skewed by sex or come mostly from consumers. Each row also shows the PRR against the other drugs of the same FDA class, which removes most confounding by the condition being treated, and a calibrated p-value: on validation, known non-causes average an ROR of about 2, so significance is judged against that empirical null (✓ = p < 0.05 after calibration). 1,173 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Right atrial hypertrophy | 90 | 764.6 471.0–1,241.2ROR 765.2 · calibrated p 2e-14 ✓ | 135.9 EB05 113.9 · IC025 +6.0 3/3 methods agree | Not in label — unassessed | serious n=90 · ♀ 0% (drug 72%) · 100% clinician | not reported in cached trials |
| Allergic granulomatous angiitis | 564 | 372.9 321.8–432.1ROR 374.6 · calibrated p 1e-12 ✓ | 117.0 EB05 109.1 · IC025 +6.6 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=564 · 100% clinician | not reported in cached trials |
| Total lung capacity increased | 157 | 236.1 185.4–300.6ROR 236.4 · calibrated p 2e-10 ✓ | 98.2 EB05 86.0 · IC025 +6.0 3/3 methods agree | Not in label — unassessed | serious n=157 · ♀ 100% (drug 72%) · 100% clinician | not reported in cached trials |
| Asthma-chronic obstructive pulmonary disease overlap syndrome | 273 | 192.5 161.9–228.9ROR 192.9 · calibrated p 7e-10 ✓ | 90.2 EB05 81.6 · IC025 +6.1 3/3 methods agree | Labeled (related wording) related wording | serious n=272 | not reported in cached trials |
| Neuropsychological symptoms | 300 | 187.4 159.1–220.8ROR 187.9 · calibrated p 9e-10 ✓ | 89.1 EB05 81.0 · IC025 +6.1 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=300 · 100% clinician | not reported in cached trials |
| Vital capacity decreased | 200 | 138.7 115.1–167.2ROR 138.9 · calibrated p 1e-8 ✓ | 76.3 EB05 67.8 · IC025 +5.8 3/3 methods agree | Not in label — unassessed | serious n=199 | not reported in cached trials |
| Prolonged expiration | 117 | 138.1 108.2–176.2ROR 138.2 · calibrated p 1e-8 ✓ | 75.7 EB05 64.9 · IC025 +5.6 3/3 methods agree | Not in label — unassessed | serious n=117 | not reported in cached trials |
| Reversible airways obstruction | 219 | 128.8 108.0–153.5ROR 129.0 · calibrated p 2e-8 ✓ | 73.2 EB05 65.4 · IC025 +5.8 3/3 methods agree | Not in label — unassessed | serious n=219 | not reported in cached trials |
| Ejection fraction | 194 | 86.1 72.4–102.3ROR 86.2 · calibrated p 4e-7 ✓ | 57.2 EB05 50.7 · IC025 +5.4 3/3 methods agree | Not in label — unassessed | serious n=194 · ♀ 100% (drug 72%) | not reported in cached trials |
| Sensitisation | 254 | 86.0 73.9–100.0ROR 86.2 · calibrated p 4e-7 ✓ | 57.2 EB05 51.5 · IC025 +5.5 3/3 methods agree | Not in label — unassessed | serious n=254 · ♀ 100% (drug 72%) | not reported in cached trials |
| Forced expiratory volume decreased | 862 | 75.6 69.8–81.9ROR 76.1 · calibrated p 8e-7 ✓ | 52.6 EB05 49.7 · IC025 +5.6 3/3 methods agree | Lab value / disease marker | serious n=856 | not reported in cached trials |
| Bronchial wall thickening | 219 | 74.9 63.9–87.8ROR 75.0 · calibrated p 1e-6 ✓ | 52.1 EB05 46.5 · IC025 +5.3 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=219 · ♀ 37% (drug 72%) | not reported in cached trials |
| Total lung capacity abnormal | 113 | 73.0 58.6–91.0ROR 73.1 · calibrated p 1e-6 ✓ | 50.9 EB05 43.5 · IC025 +5.1 3/3 methods agree | Not in label — unassessed | serious n=110 · ♀ 0% (drug 72%) · 100% clinician | not reported in cached trials |
| Spirometry abnormal | 163 | 66.4 55.4–79.6ROR 66.5 · calibrated p 2e-6 ✓ | 47.8 EB05 41.9 · IC025 +5.1 3/3 methods agree | Lab value / disease marker | serious n=162 · ♀ 0% (drug 72%) | not reported in cached trials |
| Neuropsychiatric symptoms | 243 | 62.4 53.8–72.2ROR 62.5 · calibrated p 4e-6 ✓ | 45.7 EB05 41.1 · IC025 +5.2 3/3 methods agree | Labeled — boxed warning exact term | serious n=239 · 100% clinician | not reported in cached trials |
| Pulmonary function test abnormal | 404 | 60.3 53.9–67.6ROR 60.5 · calibrated p 4e-6 ✓ | 44.7 EB05 41.2 · IC025 +5.2 3/3 methods agree | Reporting / coding artifact | serious n=397 | not reported in cached trials |
| Perfume sensitivity | 144 | 60.0 49.6–72.5ROR 60.0 · calibrated p 5e-6 ✓ | 44.3 EB05 38.6 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious n=139 | not reported in cached trials |
| Pulmonary vasculitis | 135 | 59.3 48.7–72.1ROR 59.3 · calibrated p 5e-6 ✓ | 43.9 EB05 38.1 · IC025 +5.0 3/3 methods agree | Labeled (related wording) related wording | serious n=135 · ♀ 0% (drug 72%) · 100% clinician | not reported in cached trials |
| Dust allergy | 242 | 57.9 50.1–67.0ROR 58.0 · calibrated p 6e-6 ✓ | 43.3 EB05 38.9 · IC025 +5.1 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=238 · ♀ 49% (drug 72%) | not reported in cached trials |
| Vocal cord dysfunction | 125 | 57.7 47.1–70.7ROR 57.8 · calibrated p 7e-6 ✓ | 43.1 EB05 37.1 · IC025 +4.9 3/3 methods agree | Not in label — unassessed | serious n=118 · ♀ 100% (drug 72%) | not reported in cached trials |
| Bronchial secretion retention | 289 | 51.2 44.9–58.4ROR 51.3 · calibrated p 1e-5 ✓ | 39.5 EB05 35.8 · IC025 +5.0 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=284 | not reported in cached trials |
| Blood immunoglobulin e increased | 554 | 50.9 46.3–55.9ROR 51.1 · calibrated p 1e-5 ✓ | 39.3 EB05 36.6 · IC025 +5.1 3/3 methods agree | Lab value / disease marker | serious n=529 | not reported in cached trials |
| Bronchopulmonary aspergillosis allergic | 201 | 48.5 41.5–56.7ROR 48.6 · calibrated p 2e-5 ✓ | 37.8 EB05 33.6 · IC025 +4.9 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=200 | not reported in cached trials |
| Temperature regulation disorder | 474 | 47.9 43.2–53.0ROR 48.0 · calibrated p 2e-5 ✓ | 37.5 EB05 34.8 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious n=470 · ♀ 100% (drug 72%) | not reported in cached trials |
| Obstructive airways disorder | 2,396 | 47.2 45.2–49.4ROR 48.2 · calibrated p 2e-5 ✓ | 37.2 EB05 35.9 · IC025 +5.1 3/3 methods agree | Not in label — unassessed | age-adj. PRR 48.2 · serious PRR 36.5 | not reported in cached trials |
| Mite allergy | 136 | 46.8 38.7–56.5ROR 46.8 · calibrated p 2e-5 ✓ | 36.7 EB05 31.8 · IC025 +4.7 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=134 · ♀ 0% (drug 72%) · 100% clinician | not reported in cached trials |
| Rhinitis allergic | 905 | 44.2 41.1–47.5ROR 44.5 · calibrated p 3e-5 ✓ | 35.3 EB05 33.4 · IC025 +5.0 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious n=864 | not reported in cached trials |
| Polycystic ovaries | 320 | 44.2 39.1–49.9ROR 44.3 · calibrated p 3e-5 ✓ | 35.2 EB05 32.1 · IC025 +4.9 3/3 methods agree | Not in label — unassessed | serious n=315 · ♀ 100% (drug 72%) | not reported in cached trials |
| Restrictive pulmonary disease | 205 | 36.7 31.6–42.7ROR 36.8 · calibrated p 9e-5 ✓ | 30.3 EB05 27.0 · IC025 +4.6 3/3 methods agree | Labeled (related wording) related wording | serious n=203 | not reported in cached trials |
| Mycotic allergy | 147 | 36.5 30.5–43.6ROR 36.5 · calibrated p 1e-4 ✓ | 30.1 EB05 26.2 · IC025 +4.5 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=143 · ♀ 0% (drug 72%) | not reported in cached trials |
| Laryngeal stenosis | 100 | 36.2 29.1–44.9ROR 36.2 · calibrated p 1e-4 ✓ | 29.8 EB05 25.2 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious n=100 · ♀ 100% (drug 72%) · 100% consumer | not reported in cached trials |
| Forced vital capacity decreased | 111 | 35.7 29.1–43.7ROR 35.7 · calibrated p 1e-4 ✓ | 29.5 EB05 25.2 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious n=109 | not reported in cached trials |
| Nasal polyps | 812 | 34.9 32.4–37.7ROR 35.2 · calibrated p 1e-4 ✓ | 29.1 EB05 27.5 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious n=745 | not reported in cached trials |
| Nasal oedema | 298 | 34.4 30.4–39.0ROR 34.5 · calibrated p 1e-4 ✓ | 28.7 EB05 26.1 · IC025 +4.6 3/3 methods agree | Labeled (related wording) related wording | serious n=286 · ♀ 92% (drug 72%) | not reported in cached trials |
| Eosinophilic granulomatosis with polyangiitis | 318 | 32.3 28.6–36.4ROR 32.3 · calibrated p 2e-4 ✓ | 27.2 EB05 24.8 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious n=317 · ♀ 39% (drug 72%) | not reported in cached trials |
| Lung hyperinflation | 136 | 32.2 26.8–38.7ROR 32.3 · calibrated p 2e-4 ✓ | 27.2 EB05 23.5 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious n=132 | not reported in cached trials |
| Sputum discoloured | 1,452 | 31.3 29.6–33.1ROR 31.7 · calibrated p 2e-4 ✓ | 26.6 EB05 25.5 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious PRR 32.0 | not reported in cached trials |
| Full blood count abnormal | 1,597 | 30.8 29.2–32.5ROR 31.2 · calibrated p 2e-4 ✓ | 26.2 EB05 25.2 · IC025 +4.6 3/3 methods agree | Lab value / disease marker | serious PRR 33.0 | not reported in cached trials |
| Eosinophil count abnormal | 111 | 30.2 24.7–36.9ROR 30.2 · calibrated p 3e-4 ✓ | 25.7 EB05 21.9 · IC025 +4.2 3/3 methods agree | Lab value / disease marker | serious n=106 · ♀ 100% (drug 72%) | not reported in cached trials |
| Chronic spontaneous urticaria | 155 | 28.2 23.8–33.5ROR 28.3 · calibrated p 4e-4 ✓ | 24.3 EB05 21.2 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious n=150 · ♀ 100% (drug 72%) | not reported in cached trials |
Clinical concept groups
MedDRA splits one clinical problem across several terms (e.g. "neutropenia", "neutrophil count decreased", "agranulocytosis"), which dilutes term-level signals. These rows count reports with any term in a concept group (an exact union, not a sum), compared with all other drugs. Groups are hand-built and listed in the methods.
| Concept | Reports | PRR 95% CI | Reading |
|---|---|---|---|
| Depression | 4,819 | 3.02.9–3.1 | signal |
| Anaphylaxis / angioedema | 1,970 | 2.82.6–2.9 | signal |
| Serious infection | 10,946 | 2.52.4–2.5 | signal |
| Suicidality | 3,047 | 2.22.1–2.2 | signal |
| Tendon disorder | 395 | 1.81.6–2.0 | raised |
| Interstitial lung disease | 986 | 1.81.7–1.9 | raised |
| Fall / fracture | 3,701 | 1.71.6–1.7 | raised |
| Venous thromboembolism | 2,087 | 1.71.6–1.7 | raised |
| Opportunistic infection | 1,275 | 1.61.5–1.7 | raised |
| Arrhythmia / qt | 1,507 | 1.41.3–1.4 | raised |
| Hyperglycaemia / diabetes | 2,686 | 1.31.3–1.4 | raised |
| Heart failure | 1,340 | 1.31.2–1.4 | raised |
| Pancreatitis | 560 | 1.21.1–1.3 | raised |
| Liver injury | 1,990 | 1.11.1–1.2 | raised |
| Seizure | 1,202 | 1.11.0–1.1 | raised |
| Hypoglycaemia | 586 | 1.11.0–1.1 | no difference |
Trial evidence (ClinicalTrials.gov)
✓ Trial adverse-event data found on ClinicalTrials.gov
Largest completed trials with posted results that list Montelukast as a study intervention. The right-hand column of the signal table shows whether each FAERS term was also recorded in these trials, with a real denominator (0 of 40 signal terms matched).
- NCT00092118 — The Clinical Effects of Montelukast in Patients With Perennial Allergic Rhinitis (0476-265) (N=1992, PHASE3; 5 AE terms posted; arms: Placebo; Montelukast 10 mg)
Caveats: trial populations, doses and follow-up differ from the reporting population; AE terms are sponsor-coded and matched here by wording; absence from a trial list means the term was not reported above the sponsor's frequency threshold, not that it cannot occur.
Most frequently reported reactions
By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Asthma | 14,958 | 26.6 26.1–27.0ROR 30.2 · calibrated p 3e-4 ✓ | 23.1 EB05 22.8 · IC025 +4.5 3/3 methods agree | Labeled — boxed warning exact term | age-adj. PRR 28.7 · serious PRR 27.0 | NCT00092118: 1/1,002 (0.1%) on Montelukast (serious AE) |
| Dyspnoea (shortness of breath) | 14,844 | 4.6 4.6–4.7ROR 5.2 · calibrated p 0.219 | 4.5 EB05 4.5 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | age-adj. PRR 4.6 · serious PRR 4.8 | not reported in cached trials |
| Drug ineffective (drug did not work) | 9,192 | 1.2 1.2–1.2ROR 1.2 · calibrated p 0.459 | 1.2 EB05 1.2 · IC025 +0.2 | Reporting / coding artifact | age-adj. PRR 1.5 · serious PRR 1.8 | not reported in cached trials |
| Cough | 9,063 | 5.8 5.7–5.9ROR 6.2 · calibrated p 0.140 | 5.6 EB05 5.5 · IC025 +2.5 3/3 methods agree | Labeled adverse reaction exact term | age-adj. PRR 6.0 · serious PRR 7.1 | not reported in cached trials |
| Fatigue (tiredness) | 8,691 | 1.9 1.9–2.0ROR 2.0 · calibrated p 0.956 | 1.9 EB05 1.9 · IC025 +0.9 | Labeled adverse reaction exact term | age-adj. PRR 2.0 · serious PRR 2.4 | not reported in cached trials |
| Headache | 8,235 | 2.3 2.2–2.3ROR 2.4 · calibrated p 0.861 | 2.3 EB05 2.2 · IC025 +1.2 3/3 methods agree | Labeled adverse reaction exact term | age-adj. PRR 2.2 · serious PRR 3.0 | not reported in cached trials |
| Wheezing | 7,647 | 25.6 25.0–26.2ROR 27.3 · calibrated p 4e-4 ✓ | 22.4 EB05 22.0 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | age-adj. PRR 26.6 · serious PRR 26.5 | not reported in cached trials |
| Pneumonia (lung infection) | 7,016 | 3.8 3.7–3.9ROR 4.0 · calibrated p 0.378 | 3.8 EB05 3.7 · IC025 +1.9 3/3 methods agree | Labeled (related wording) related wording | age-adj. PRR 3.8 · serious PRR 3.7 | not reported in cached trials |
| Nausea | 6,812 | 1.5 1.5–1.5ROR 1.5 · calibrated p 0.661 | 1.5 EB05 1.5 · IC025 +0.5 | Labeled adverse reaction exact term | age-adj. PRR 1.4 · serious PRR 1.7 | not reported in cached trials |
| Pain | 6,543 | 1.9 1.8–1.9ROR 1.9 · calibrated p 0.888 | 1.8 EB05 1.8 · IC025 +0.8 | Labeled adverse reaction exact term | age-adj. PRR 2.2 · serious PRR 2.1 | not reported in cached trials |
| Malaise (feeling unwell) | 5,300 | 2.1 2.0–2.2ROR 2.2 · calibrated p 0.976 | 2.1 EB05 2.0 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | age-adj. PRR 2.3 · serious PRR 2.6 | not reported in cached trials |
| Dizziness | 4,870 | 1.7 1.7–1.7ROR 1.7 · calibrated p 0.788 | 1.7 EB05 1.7 · IC025 +0.7 | Labeled adverse reaction exact term | age-adj. PRR 1.7 · serious PRR 2.0 | not reported in cached trials |
| Diarrhoea (diarrhea) | 4,849 | 1.3 1.3–1.3ROR 1.3 · calibrated p 0.522 | 1.3 EB05 1.3 · IC025 +0.3 | Labeled adverse reaction exact term | age-adj. PRR 1.3 · serious PRR 1.4 | not reported in cached trials |
| Anxiety | 4,826 | 3.0 2.9–3.0ROR 3.0 · calibrated p 0.612 | 2.9 EB05 2.9 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | age-adj. PRR 3.1 · serious PRR 3.4 | NCT00092118: 1/1,002 (0.1%) on Montelukast (serious AE) |
| Off label use (used outside approved label) | 4,692 | 0.9 0.9–1.0ROR 0.9 · calibrated p 0.264 | 0.9 EB05 0.9 · IC025 -0.1 PRR-only: not supported by EBGM or IC | Reporting / coding artifact | age-adj. PRR 0.8 · serious PRR 1.0 | not reported in cached trials |
Unlabeled candidate signals
These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.
- Right atrial hypertrophy — n=90, PRR 764.6
- Total lung capacity increased — n=157, PRR 236.1
- Vital capacity decreased — n=200, PRR 138.7
- Prolonged expiration — n=117, PRR 138.1
- Reversible airways obstruction — n=219, PRR 128.8
- Ejection fraction — n=194, PRR 86.1
- Sensitisation — n=254, PRR 86.0
- Total lung capacity abnormal — n=113, PRR 73.0
- Perfume sensitivity — n=144, PRR 60.0
- Vocal cord dysfunction — n=125, PRR 57.7
✓ A hand-written Bradford Hill causality assessment exists for this drug: Montelukast ↔ Neuropsychiatric events.
Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.
Common questions
What are the most reported side effects of Montelukast?
In FDA FAERS, the most frequently co-reported reaction terms for Montelukast are asthma, dyspnoea, cough, fatigue, headache, wheezing. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.
Does Montelukast have an FDA boxed warning?
Yes. The current FDA label carries a boxed warning: SERIOUS NEUROPSYCHIATRIC EVENTS Serious neuropsychiatric (NP) events have been reported with the use of montelukast sodium. The types of events reported were highly variable, and included, but were not limited to, agitation, aggression, depression, sleep disturbances, suicidal thoughts and behavior (including suicide).
Do FAERS signals prove that Montelukast causes these side effects?
No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.
Sources & methods
- FDA label via openFDA (set ID 4fe3c0d4-94ff-43ca-9d24-54676fe593fe, effective 20210626; matched on
openfda.generic_name.exact:"MONTELUKAST" AND openfda.product_type:"HUMAN PRESCRIPTION DRUG") - PubChem CID 5281040 description (ChEBI)
- Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
- FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA
count=aggregation, fieldpatient.drug.openfda.generic_name.exact, 1,213 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction - Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
- Seriousness and sex counts from openFDA
count=serious,patient.patientsex,seriousnessdeath - ClinicalTrials.gov API v2 (query
MONTELUKAST, results-bearing studies sorted by enrollment)
Page generated 2026-10-14. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.