82/100 · Critical
Manufactured by Major Pharmaceuticals
Cetirizine Adverse Events: High Seriousness and Diverse Reactions
493,372 FDA adverse event reports analyzed
Last updated: 2026-05-12
CETIRIZINE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Major Pharmaceuticals. Based on analysis of 493,372 FDA adverse event reports, CETIRIZINE has a safety score of 82 out of 100. This score indicates a relatively favorable safety profile, with fewer or less severe adverse events compared to many other tracked medications. The most commonly reported adverse reactions for CETIRIZINE include DRUG INEFFECTIVE, FATIGUE, PAIN, RASH, OFF LABEL USE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for CETIRIZINE.
Cetirizine has a safety concern score of 82 out of 100, placing it in the high concern category based on analysis of FDA adverse event data. The FDA has received approximately 493,372 adverse event reports for this medication, which is primarily manufactured by Major Pharmaceuticals.
The most commonly reported adverse events include Drug Ineffective, Fatigue, Pain. Of classified reports, 76.2% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. High percentage of serious adverse events (76.2%) indicates significant safety concerns.
A wide range of reactions reported, including systemic lupus erythematosus and pericarditis, suggesting potential severe side effects. Report volume is substantial, with over 493,000 reports, providing a comprehensive dataset for analysis.
Patients taking Cetirizine should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Cetirizine is contraindicated in patients with known hypersensitivity to the drug. It should be used with caution in patients with pre-existing liver or kidney conditions. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Cetirizine received a safety concern score of 82/100 (high concern). This is based on a 76.2% serious event ratio across 72,697 classified reports. The score accounts for 493,372 total adverse event reports and 100 distinct reaction types. This high score reflects a significant proportion of serious adverse events in the reporting data.
Adverse event reports by sex: Female: 44,740, Male: 18,378, Unknown: 60. The most frequently reported age groups are age 43 (2,597 reports), age 44 (2,551 reports), age 40 (1,380 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 72,697 classified reports for CETIRIZINE:
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.
Cetirizine is contraindicated in patients with known hypersensitivity to the drug. It should be used with caution in patients with pre-existing liver or kidney conditions.
If you are taking Cetirizine, here are important things to know. The most commonly reported side effects include drug ineffective, fatigue, pain, rash, off label use. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Consumers should report any adverse reactions to the FDA's MedWatch program. Follow prescribed dosages and consult a healthcare provider if any unusual symptoms occur. 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 cetirizine for safety, and regulatory actions may be taken based on ongoing data analysis.
The FDA has received approximately 493,372 adverse event reports associated with Cetirizine. 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 Cetirizine include Drug Ineffective, Fatigue, Pain, Rash, Off Label Use. By volume, the top reported reactions are: Drug Ineffective (12,975 reports), Fatigue (12,861 reports), Pain (12,124 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Cetirizine.
Out of 72,697 classified reports, 55,406 (76.2%) were classified as serious and 17,291 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 Cetirizine break down by patient sex as follows: Female: 44,740, Male: 18,378, Unknown: 60. 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 Cetirizine adverse events are: age 43: 2,597 reports, age 44: 2,551 reports, age 40: 1,380 reports, age 59: 1,160 reports, age 58: 963 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 Cetirizine adverse event reports is Major Pharmaceuticals. 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 Cetirizine include: Abdominal Discomfort, Alopecia, Rheumatoid Arthritis, Systemic Lupus Erythematosus, Pemphigus. 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 Cetirizine 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.
Cetirizine has a safety concern score of 82 out of 100 (high 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. High percentage of serious adverse events (76.2%) indicates significant safety concerns.
Key safety signals identified in Cetirizine's adverse event data include: Systemic lupus erythematosus and rheumatoid arthritis are notable as they indicate potential autoimmune reactions.. Pericarditis and other cardiovascular issues are significant, given the serious nature of these events.. Multiple gastrointestinal issues, including duodenal ulcer perforation and hepatitis, are frequently reported.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Cetirizine is contraindicated in patients with known hypersensitivity to the drug. It should be used with caution in patients with pre-existing liver or kidney conditions. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Cetirizine.
Consumers should report any adverse reactions to the FDA's MedWatch program. Follow prescribed dosages and consult a healthcare provider if any unusual symptoms occur.
Cetirizine has 493,372 adverse event reports on file with the FDA. A wide range of reactions reported, including systemic lupus erythematosus and pericarditis, suggesting potential severe side effects. The volume of reports for Cetirizine reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor cetirizine for safety, and regulatory actions may be taken based on ongoing data analysis. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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