Montelukast vs Loratadine: side effects in FDA adverse event reports
At a glance
| Montelukast | Loratadine | |
|---|---|---|
| Drug class | – | – |
| Brand names | – | – |
| FAERS reports | 121,015 | 106,935 |
| Serious | 60% | 47% |
| Death outcome | 4,918 | 4,661 |
| Boxed warning | Yes SERIOUS NEUROPSYCHIATRIC EVENTS Serious neuropsychiatric (NP) events have been reported with the use of montelukast sodium. The types of events reported were hi | No |
Signals both drugs share
| Reaction | Montelukast | Loratadine | Label screen (A / B) |
|---|---|---|---|
| Rhinitis allergic | 905 · PRR 44.2 | 154 · PRR 7.0 | Likely indication confounding / No label text to screen |
| Chronic spontaneous urticaria | 155 · PRR 28.2 | 99 · PRR 19.3 | Not in label — unassessed / No label text to screen |
Labeled signals distinctive to Montelukast
- Nasal oedema — n=298, PRR 34.4 Labeled (related wording)
- Asthma-chronic obstructive pulmonary disease overlap syndrome — n=273, PRR 192.5 Labeled (related wording)
- Neuropsychiatric symptoms — n=243, PRR 62.4 Labeled — boxed warning
- Restrictive pulmonary disease — n=205, PRR 36.7 Labeled (related wording)
- Pulmonary vasculitis — n=135, PRR 59.3 Labeled (related wording)
Labeled signals distinctive to Loratadine
- None stood out among the strongest labeled signals.
Common questions
Which has more reported side effects, Montelukast or Loratadine?
Montelukast has 121,015 FAERS reports and Loratadine 106,935. 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 (60% vs 47%) is a better like-for-like signal of the kind of problems reported.
Which side effects do Montelukast and Loratadine share?
Both drugs carry disproportionality signals for rhinitis allergic, chronic spontaneous urticaria. Shared signals often reflect a shared drug class or the condition both are used for.
Is Montelukast or Loratadine 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.