Tiotropium vs Montelukast: side effects in FDA adverse event reports
At a glance
| Tiotropium | Montelukast | |
|---|---|---|
| Drug class | – | – |
| Brand names | Tiotropium Bromide | – |
| FAERS reports | 136,142 | 121,015 |
| Serious | 50% | 60% |
| Death outcome | 9,792 | 4,918 |
| Boxed warning | No | Yes SERIOUS NEUROPSYCHIATRIC EVENTS Serious neuropsychiatric (NP) events have been reported with the use of montelukast sodium. The types of events reported were hi |
Signals both drugs share
| Reaction | Tiotropium | Montelukast | Label screen (A / B) |
|---|---|---|---|
| Asthma-chronic obstructive pulmonary disease overlap syndrome | 271 · PRR 168.4 | 273 · PRR 192.5 | Likely indication confounding / Labeled (related wording) |
| Restrictive pulmonary disease | 173 · PRR 26.6 | 205 · PRR 36.7 | Not in label — unassessed / Labeled (related wording) |
| Pulmonary vasculitis | 151 · PRR 61.4 | 135 · PRR 59.3 | Not in label — unassessed / Labeled (related wording) |
| Right atrial hypertrophy | 89 · PRR 639.8 | 90 · PRR 764.6 | Labeled (related wording) / Not in label — unassessed |
| Obstructive airways disorder | 2,820 · PRR 51.9 | 2,396 · PRR 47.2 | Likely indication confounding / Not in label — unassessed |
| Sputum discoloured | 1,395 · PRR 26.5 | 1,452 · PRR 31.3 | Not in label — unassessed / Not in label — unassessed |
| Eosinophilic granulomatosis with polyangiitis | 294 · PRR 26.1 | 318 · PRR 32.3 | Not in label — unassessed / Not in label — unassessed |
| Dust allergy | 359 · PRR 91.4 | 242 · PRR 57.9 | Not in label — unassessed / Likely indication confounding |
| Bronchial secretion retention | 245 · PRR 36.9 | 289 · PRR 51.2 | Likely indication confounding / Likely indication confounding |
| Bronchial wall thickening | 248 · PRR 80.0 | 219 · PRR 74.9 | Likely indication confounding / Likely indication confounding |
| Mycotic allergy | 295 · PRR 82.9 | 147 · PRR 36.5 | Not in label — unassessed / Likely indication confounding |
| Mite allergy | 299 · PRR 136.4 | 136 · PRR 46.8 | Not in label — unassessed / Likely indication confounding |
| Bronchopulmonary aspergillosis allergic | 205 · PRR 44.2 | 201 · PRR 48.5 | Likely indication confounding / Likely indication confounding |
| Reversible airways obstruction | 184 · PRR 85.7 | 219 · PRR 128.8 | Likely indication confounding / Not in label — unassessed |
| Lung hyperinflation | 195 · PRR 44.7 | 136 · PRR 32.2 | Not in label — unassessed / Not in label — unassessed |
| Total lung capacity increased | 152 · PRR 194.5 | 157 · PRR 236.1 | Not in label — unassessed / Not in label — unassessed |
| Vital capacity decreased | 107 · PRR 47.8 | 200 · PRR 138.7 | Not in label — unassessed / Not in label — unassessed |
| Forced vital capacity decreased | 161 · PRR 50.7 | 111 · PRR 35.7 | Not in label — unassessed / Not in label — unassessed |
| Total lung capacity abnormal | 152 · PRR 102.4 | 113 · PRR 73.0 | Not in label — unassessed / Not in label — unassessed |
| Vocal cord dysfunction | 111 · PRR 43.9 | 125 · PRR 57.7 | Not in label — unassessed / Not in label — unassessed |
Labeled signals distinctive to Tiotropium
- None stood out among the strongest labeled signals.
Labeled signals distinctive to Montelukast
- Nasal oedema — n=298, PRR 34.4 Labeled (related wording)
- Neuropsychiatric symptoms — n=243, PRR 62.4 Labeled — boxed warning
Common questions
Which has more reported side effects, Tiotropium or Montelukast?
Tiotropium has 136,142 FAERS reports and Montelukast 121,015. More reports does not mean more dangerous: volume follows how widely and how long a drug has been used, prescription vs over-the-counter status, and publicity. The seriousness share (50% vs 60%) is a better like-for-like signal of the kind of problems reported.
Which side effects do Tiotropium and Montelukast share?
Both drugs carry disproportionality signals for asthma-chronic obstructive pulmonary disease overlap syndrome, restrictive pulmonary disease, pulmonary vasculitis, right atrial hypertrophy, obstructive airways disorder. Shared signals often reflect a shared drug class or the condition both are used for.
Is Tiotropium or Montelukast safer?
FAERS cannot answer that: it has no denominator and no comparator. Use this page to see which risks are already on each label and which signals are unlabeled, then check the prescribing information and your clinician for your situation.
Sources: openFDA FAERS pair statistics (OpenPV build 2026-09-14), FDA labels via openFDA, openFDA count queries for seriousness and deaths. Pair chosen because it is a commonly searched comparison. Generated 2026-10-08.