45/100 · Moderate
Manufactured by Lil' Drug Store Products, Inc.
Loratadine Tablet Adverse Events: Mild to Moderate Reactions Predominate
95,541 FDA adverse event reports analyzed
Last updated: 2026-05-12
LORATADINE TABLET is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Lil' Drug Store Products, Inc.. Based on analysis of 95,541 FDA adverse event reports, LORATADINE TABLET 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 TABLET 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 TABLET.
Loratadine Tablet 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 95,541 adverse event reports for this medication, which is primarily manufactured by Lil' Drug Store Products, Inc..
The most commonly reported adverse events include Drug Ineffective, Fatigue, Nausea. Of classified reports, 36.9% 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, with fatigue and nausea being the most common.
The majority of reactions are non-serious, but a significant portion (36.9%) are serious. The reaction diversity is high, with over 100 distinct reactions reported.
Patients taking Loratadine Tablet 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 warned about potential falls and respiratory issues. Overdose and incorrect dosing are common, so caution is advised. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Loratadine Tablet received a safety concern score of 45/100 (moderate concern). This is based on a 36.9% serious event ratio across 51,859 classified reports. The score accounts for 95,541 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: 32,139, Male: 14,676, Unknown: 224. The most frequently reported age groups are age 64 (617 reports), age 65 (602 reports), age 70 (569 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 51,859 classified reports for LORATADINE TABLET:
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 warned about potential falls and respiratory issues. Overdose and incorrect dosing are common, so caution is advised.
If you are taking Loratadine Tablet, 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. Always follow the prescribed dosage and instructions for use. Report any serious or unusual reactions to your healthcare provider. 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. Consumers should follow prescribed dosages and report any unusual symptoms to their healthcare provider.
The FDA has received approximately 95,541 adverse event reports associated with Loratadine Tablet. 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 Tablet include Drug Ineffective, Fatigue, Nausea, Headache, Diarrhoea. By volume, the top reported reactions are: Drug Ineffective (7,899 reports), Fatigue (3,163 reports), Nausea (2,927 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 Tablet.
Out of 51,859 classified reports, 19,135 (36.9%) were classified as serious and 32,724 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 Tablet break down by patient sex as follows: Female: 32,139, Male: 14,676, Unknown: 224. 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 Tablet adverse events are: age 64: 617 reports, age 65: 602 reports, age 70: 569 reports, age 60: 568 reports, age 67: 557 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 Tablet adverse event reports is Lil' Drug Store Products, 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 Tablet 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 Tablet 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 Tablet 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 reported reactions are mild to moderate in severity, with fatigue and nausea being the most common.
Key safety signals identified in Loratadine Tablet's adverse event data include: Falls and pneumonia are notable serious reactions.. Overdose and incorrect dose administration are common issues.. There are reports of weight changes and renal failure.. 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 warned about potential falls and respiratory issues. Overdose and incorrect dosing are common, so caution is advised. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Loratadine Tablet.
Always follow the prescribed dosage and instructions for use. Report any serious or unusual reactions to your healthcare provider.
Loratadine Tablet has 95,541 adverse event reports on file with the FDA. The majority of reactions are non-serious, but a significant portion (36.9%) are serious. The volume of reports for Loratadine Tablet reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor loratadine for safety. Consumers should follow prescribed dosages and report any unusual symptoms to their healthcare provider. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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