35/100 · Moderate
Manufactured by Bayer HealthCare LLC.
Loratadine Adverse Events: Mild to Moderate Reactions Predominate
188,705 FDA adverse event reports analyzed
Last updated: 2026-05-12
LORATADINE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Bayer HealthCare LLC.. Based on analysis of 188,705 FDA adverse event reports, LORATADINE has a safety score of 35 out of 100. This lower score reflects a significant number of adverse event reports, suggesting that patients should discuss potential risks carefully with their healthcare provider. The most commonly reported adverse reactions for LORATADINE include DRUG INEFFECTIVE, FATIGUE, NAUSEA, HEADACHE, DIARRHOEA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for LORATADINE.
Loratadine has a safety concern score of 35 out of 100, placing it in the moderate concern category based on analysis of FDA adverse event data. The FDA has received approximately 188,705 adverse event reports for this medication, which is primarily manufactured by Bayer Healthcare Llc..
The most commonly reported adverse events include Drug Ineffective, Fatigue, Nausea. Of classified reports, 46.5% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Most reported reactions are mild to moderate in severity.
The majority of reactions are related to gastrointestinal and neurological symptoms. Serious reactions, while present, are less frequent, comprising about 46.5% of all reports.
Patients taking Loratadine should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Loratadine is generally well-tolerated, but patients should be advised to avoid extra doses and to be cautious with drug interactions. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Loratadine received a safety concern score of 35/100 (moderate concern). This is based on a 46.5% serious event ratio across 104,301 classified reports. The score accounts for 188,705 total adverse event reports and 100 distinct reaction types. This moderate score is typical for widely prescribed medications with established safety profiles.
Adverse event reports by sex: Female: 63,049, Male: 32,089, Unknown: 281. The most frequently reported age groups are age 64 (1,502 reports), age 65 (1,360 reports), age 63 (1,311 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 104,301 classified reports for LORATADINE:
The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.
Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.
Loratadine is generally well-tolerated, but patients should be advised to avoid extra doses and to be cautious with drug interactions.
If you are taking Loratadine, here are important things to know. The most commonly reported side effects include drug ineffective, fatigue, nausea, headache, diarrhoea. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Follow the prescribed dosage and do not exceed the recommended amount. Be cautious when taking loratadine with other medications to avoid potential interactions. If you experience a serious adverse reaction, seek emergency medical attention immediately or call 911. You can report side effects to the FDA's MedWatch program at 1-800-FDA-1088.
The FDA continues to monitor loratadine for safety, and no major safety concerns have been identified to date.
The FDA has received approximately 188,705 adverse event reports associated with Loratadine. These reports come from healthcare professionals, consumers, and manufacturers through the FDA Adverse Event Reporting System (FAERS). Note that the number of reports does not directly indicate the frequency of side effects, as adverse events are voluntarily reported and may be underrepresented.
The most frequently reported adverse events for Loratadine include Drug Ineffective, Fatigue, Nausea, Headache, Diarrhoea. By volume, the top reported reactions are: Drug Ineffective (12,885 reports), Fatigue (6,410 reports), Nausea (5,696 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Loratadine.
Out of 104,301 classified reports, 48,512 (46.5%) were classified as serious and 55,789 as non-serious. The FDA classifies an event as "serious" if it results in death, hospitalization, disability, or other medically significant outcomes. A higher serious-event ratio warrants closer attention but does not necessarily mean the drug is unsafe.
Adverse event reports for Loratadine break down by patient sex as follows: Female: 63,049, Male: 32,089, Unknown: 281. This distribution reflects reporting patterns rather than actual risk differences between groups. Reporting rates can be influenced by prescribing patterns, disease demographics, and reporting behavior.
The most frequently reported age groups for Loratadine adverse events are: age 64: 1,502 reports, age 65: 1,360 reports, age 63: 1,311 reports, age 68: 1,303 reports, age 69: 1,296 reports. Age-related reporting patterns can reflect both the demographics of the patient population and potential age-related susceptibility to certain side effects.
The primary manufacturer associated with Loratadine adverse event reports is Bayer Healthcare Llc.. Multiple manufacturers may produce generic versions of this drug. The manufacturer listed reflects the most frequently reported brand in FDA adverse event data.
Beyond the most common reactions, other reported adverse events for Loratadine include: Dyspnoea, Off Label Use, Dizziness, Pain, Rash. Less common side effects can still be clinically significant. Patients should report any unusual symptoms to their healthcare provider.
You can report adverse events from Loratadine to the FDA through their MedWatch program at www.fda.gov/medwatch, by calling 1-800-FDA-1088, or by completing Form FDA 3500. Healthcare professionals, consumers, and manufacturers can all submit reports. Reporting helps the FDA monitor drug safety after approval.
Loratadine has a safety concern score of 35 out of 100 (moderate concern). This score is calculated from the ratio of serious to non-serious adverse events, the diversity of reported reactions, and the overall volume of reports relative to usage. Most reported reactions are mild to moderate in severity.
Key safety signals identified in Loratadine's adverse event data include: Frequent reports of fatigue, nausea, and headache suggest common side effects.. Serious reactions such as pneumonia and death are reported but less frequently.. Drug interactions and overdose are noted as key safety signals.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Loratadine is generally well-tolerated, but patients should be advised to avoid extra doses and to be cautious with drug interactions. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Loratadine.
Follow the prescribed dosage and do not exceed the recommended amount. Be cautious when taking loratadine with other medications to avoid potential interactions.
Loratadine has 188,705 adverse event reports on file with the FDA. The majority of reactions are related to gastrointestinal and neurological symptoms. The volume of reports for Loratadine reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor loratadine for safety, and no major safety concerns have been identified to date. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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