Loratadineloratadine

Name: LORATADINE (loratadine) — FDA Adverse Event Reports
Creator: PillSignal
License: https://open.fda.gov/license/

According to the FDA label: TEMPORARILY RELIEVES THESE SYMPTOMS DUE TO HAY FEVER OR OTHR UPPER RESPIRATORY ALLERGIES: RUNNY NOSE ITCHY, WATERY EYES SNEEZING ITCHING OF THE NOSE OR THROAT

47,904 adverse event reports submitted to the FDA (2004–2026)

This data reflects voluntary reports submitted to the FDA's Adverse Event Monitoring System (AEMS), formerly the FDA Adverse Event Reporting System (FAERS). A report does not mean the medication caused the event. Data may be incomplete or contain errors. Learn more about AEMS. New to this data? Read our guide on how to interpret FDA adverse event reports →

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Top Reported Adverse Events

The most frequently reported events in association with Loratadine in the FAERS database. These are events reported by patients taking this medication, not necessarily caused by it. A single report may include multiple events.

Ranked by frequency of reports, not severity. The most-reported event is not necessarily the most dangerous or the most common in patients taking this drug.

Who Is Reporting

Demographics of patients in FAERS reports that included this information. Not all reports include patient demographics.

By Sex

By Age Group

This shows who filed reports, reflecting who takes this drug and who tends to report, not who is at greatest risk.

Reported Outcomes

Outcomes recorded in FAERS reports that included Loratadine. A single report may involve multiple reactions, each with a different outcome. These categories are defined by FDA reporting guidelines, not by PillSignal.

Serious outcomes are far more likely to be reported than mild ones, so this overstates how often outcomes are serious. A recorded death does not mean the drug caused it.

Report Volume Over Time

Number of FAERS reports received per quarter for Loratadine. Changes in volume may reflect shifts in prescribing rates, media attention, or reporting behavior, not changes in the medication's safety profile.

The steep increase around 2004 reflects the FDA's move to electronic submission, not a change in this drug's safety. Trends track reporting volume, not risk.

Other medications with similar adverse event profiles in FDA FAERS reports.

Data Source

This data is sourced from the FDA's Adverse Event Monitoring System (AEMS), formerly FAERS, via the OpenFDA API. PillSignal is not affiliated with the FDA.

View this data on the FDA website →

Data last updated: June 2026