45/100 · Moderate
Manufactured by AAA PHARMACEUTICAL, INC.
Loratadine Oral Reports Show Mostly Mild Reactions, with Serious Cases Notable
88,572 FDA adverse event reports analyzed
Last updated: 2026-05-12
LORATADINE ORAL is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by AAA PHARMACEUTICAL, INC.. Based on analysis of 88,572 FDA adverse event reports, LORATADINE ORAL has a safety score of 45 out of 100. This moderate score indicates a notable volume of adverse event reports that patients and providers should be aware of. The most commonly reported adverse reactions for LORATADINE ORAL include DRUG INEFFECTIVE, FATIGUE, NAUSEA, DYSPNOEA, HEADACHE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for LORATADINE ORAL.
Loratadine Oral has a safety concern score of 45 out of 100, placing it in the moderate concern category based on analysis of FDA adverse event data. The FDA has received approximately 88,572 adverse event reports for this medication, which is primarily manufactured by Aaa Pharmaceutical, Inc..
The most commonly reported adverse events include Drug Ineffective, Fatigue, Nausea. Of classified reports, 60.5% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Most reactions are mild to moderate, with fatigue, nausea, and dizziness being the most common.
Serious reactions, such as pneumonia and death, are reported but less frequent. Off-label use and drug ineffectiveness are also reported, indicating potential misuse. The majority of reports come from older adults, with the highest number of reports from those aged 65-70.
Patients taking Loratadine Oral 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 caution is advised in patients with kidney disease or those taking other medications, as drug interactions can occur. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Loratadine Oral received a safety concern score of 45/100 (moderate concern). This is based on a 60.5% serious event ratio across 47,068 classified reports. The score accounts for 88,572 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: 27,828, Male: 15,577, Unknown: 41. The most frequently reported age groups are age 64 (892 reports), age 63 (732 reports), age 68 (731 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 47,068 classified reports for LORATADINE ORAL:
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 caution is advised in patients with kidney disease or those taking other medications, as drug interactions can occur.
If you are taking Loratadine Oral, here are important things to know. The most commonly reported side effects include drug ineffective, fatigue, nausea, dyspnoea, headache. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Always follow the prescribed dosage and instructions for use. Report any unusual symptoms to your healthcare provider promptly. 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 updates will be provided as necessary. Consumers should report any adverse reactions to the FDA's MedWatch program.
The FDA has received approximately 88,572 adverse event reports associated with Loratadine Oral. 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 Oral include Drug Ineffective, Fatigue, Nausea, Dyspnoea, Headache. By volume, the top reported reactions are: Drug Ineffective (3,510 reports), Fatigue (3,149 reports), Nausea (2,639 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 Oral.
Out of 47,068 classified reports, 28,463 (60.5%) were classified as serious and 18,605 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 Oral break down by patient sex as follows: Female: 27,828, Male: 15,577, Unknown: 41. 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 Oral adverse events are: age 64: 892 reports, age 63: 732 reports, age 68: 731 reports, age 65: 704 reports, age 59: 698 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 Oral adverse event reports is Aaa Pharmaceutical, Inc.. 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 Oral include: Diarrhoea, 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 Oral 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 Oral has a safety concern score of 45 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 reactions are mild to moderate, with fatigue, nausea, and dizziness being the most common.
Key safety signals identified in Loratadine Oral's adverse event data include: Pneumonia and death are key serious adverse events, though less common.. Off-label use and drug ineffectiveness suggest potential misuse or incorrect dosing.. Falls and chronic kidney disease are notable, indicating potential risks in elderly patients.. 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 caution is advised in patients with kidney disease or those taking other medications, as drug interactions can occur. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Loratadine Oral.
Always follow the prescribed dosage and instructions for use. Report any unusual symptoms to your healthcare provider promptly.
Loratadine Oral has 88,572 adverse event reports on file with the FDA. Serious reactions, such as pneumonia and death, are reported but less frequent. The volume of reports for Loratadine Oral reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor loratadine for safety, and updates will be provided as necessary. Consumers should report any adverse reactions to the FDA's MedWatch program. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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