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This page presents data from the FDA Adverse Event Reporting System (FAERS) and the FDA-approved drug label. A report submitted to FAERS does not prove a drug caused the reported event. Always consult a healthcare provider about medications.

Allergy Relief (loratadine)

Last updated: June 19, 2026
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Allergy Relief is the brand name for loratadine. According to the FDA-approved label, temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: • runny nose • itchy, watery eyes • sneezing • itching of the nose or throat. FAERS contains 105,873 submissions naming this drug from 2003 through 2026; the top three reactions cited are drug ineffective, fatigue, and nausea.

Most-Reported Reactions

Counts of the reactions most often cited in FAERS submissions that named Allergy Relief. Inclusion here does not establish causation - submitters describe what was observed, not what was confirmed. One submission can list several reactions, so the totals exceed the report count.

DRUG INEFFECTIVE 13,016 (12.3%) FATIGUE 6,534 (6.2%) NAUSEA 5,790 (5.5%) HEADACHE 5,278 (5.0%) DIARRHOEA 4,753 (4.5%) DYSPNOEA 4,731 (4.5%) OFF LABEL USE 4,568 (4.3%) DIZZINESS 4,297 (4.1%) PAIN 4,041 (3.8%) RASH 3,390 (3.2%) PRURITUS 3,265 (3.1%) COUGH 3,013 (2.8%) VOMITING 2,973 (2.8%) SOMNOLENCE 2,946 (2.8%) ARTHRALGIA 2,818 (2.7%)

Patient Demographics

Patient sex and age across the FAERS submissions that named Allergy Relief. Percentages here are computed only from submissions where these fields were filled in - many leave them blank.

By Sex

Female Male Unknown

By Age Group

0-17 18-44 45-64 65+

Severity Outcomes

Severity flags recorded across the 105,873 FAERS submissions that named Allergy Relief. Each bar shows the count of those reports carrying that flag. A single case can carry more than one (a hospitalization that became life-threatening, for example), so these bars are independent rates - they don't sum to 100%. Inclusion of a case under any flag does not establish that the drug caused the outcome.

DEATH 4,597 (4.3%) HOSPITALIZATION 22,802 (21.5%) LIFE-THREATENING 2,485 (2.3%) DISABLING 2,203 (2.1%)

Submissions Per Quarter

Quarterly count of FAERS submissions that named Allergy Relief. Ups and downs on this chart can track prescribing volume, news cycles, or shifts in how reports get filed, rather than the drug becoming safer or more dangerous.

2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025 2026

From the FDA-Approved Label

Excerpts from the official FDA-approved prescribing information for Allergy Relief. This is the authoritative source on indications, warnings, and known adverse reactions.

Indications

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: • runny nose • itchy, watery eyes • sneezing • itching of the nose or throat

Warnings

Do not use if you have ever had an allergic reaction to this product or any of its ingredients Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose. When using this product do not take more than directed. Taking more than directed may cause drowsiness. Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

FDA label effective date: 2026-02-25

Disclaimer

AdverseEvent.ai is not affiliated with the FDA. Adverse-event counts come from the FDA Adverse Event Reporting System (FAERS). Drug labels come from the FDA drug label dataset. A report submitted to FAERS does not prove a drug caused the reported event — always consult a healthcare provider about medications. This site is for informational purposes only and is not medical advice.