What the label lists and what reports show
Loratadine side effects
Loratadine's FDA label lists its adverse reactions in its own words. FAERS holds 106,995 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is fatigue (6,654 reports).
- Generic listed
Check it at the source: the loratadine FDA label on DailyMed (effective December 5, 2025, Bayer HealthCare LLC.); the FDA FAERS public dashboard.
What do FAERS reports show?
106,995 reports list loratadine among the medicines taken, each a report of something that happened, not proof the medicine caused it; 4,661 are coded as a death and 23,139 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 23 reactions below, 2 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Loratadine: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions