85/100 · Critical
Manufactured by Aurohealth LLC
High Serious Reaction Rate for CETIRIZINE HYDROCHLORIDE ALLERGY
341,924 FDA adverse event reports analyzed
Last updated: 2026-05-12
CETIRIZINE HYDROCHLORIDE ALLERGY is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Aurohealth LLC. Based on analysis of 341,924 FDA adverse event reports, CETIRIZINE HYDROCHLORIDE ALLERGY has a safety score of 85 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 HYDROCHLORIDE ALLERGY include DRUG INEFFECTIVE, PAIN, FATIGUE, ALOPECIA, ABDOMINAL DISCOMFORT. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for CETIRIZINE HYDROCHLORIDE ALLERGY.
Cetirizine Hydrochloride Allergy has a safety concern score of 85 out of 100, placing it in the high concern category based on analysis of FDA adverse event data. The FDA has received approximately 341,924 adverse event reports for this medication, which is primarily manufactured by Aurohealth Llc.
The most commonly reported adverse events include Drug Ineffective, Pain, Fatigue. Of classified reports, 78.5% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. The majority of reactions are non-serious, but the serious reaction rate is high at 78.5%.
A wide range of reactions are reported, indicating potential for diverse side effects. Report volume is substantial, with over 340,000 total reports.
Patients taking Cetirizine Hydrochloride Allergy should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Cetirizine hydrochloride allergy may interact with other drugs, and contraindicated products should be avoided. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Cetirizine Hydrochloride Allergy received a safety concern score of 85/100 (high concern). This is based on a 78.5% serious event ratio across 28,576 classified reports. The score accounts for 341,924 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: 18,814, Male: 4,986, Unknown: 22. The most frequently reported age groups are age 43 (1,831 reports), age 44 (1,578 reports), age 40 (836 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 28,576 classified reports for CETIRIZINE HYDROCHLORIDE ALLERGY:
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 hydrochloride allergy may interact with other drugs, and contraindicated products should be avoided.
If you are taking Cetirizine Hydrochloride Allergy, here are important things to know. The most commonly reported side effects include drug ineffective, pain, fatigue, alopecia, abdominal discomfort. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Consult a healthcare provider if experiencing severe or persistent side effects. Report any adverse reactions to the FDA's MedWatch program. 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 hydrochloride allergy for safety concerns, with ongoing reviews.
The FDA has received approximately 341,924 adverse event reports associated with Cetirizine Hydrochloride Allergy. 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 Hydrochloride Allergy include Drug Ineffective, Pain, Fatigue, Alopecia, Abdominal Discomfort. By volume, the top reported reactions are: Drug Ineffective (9,070 reports), Pain (8,608 reports), Fatigue (8,443 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 Hydrochloride Allergy.
Out of 28,576 classified reports, 22,419 (78.5%) were classified as serious and 6,157 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 Hydrochloride Allergy break down by patient sex as follows: Female: 18,814, Male: 4,986, Unknown: 22. 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 Hydrochloride Allergy adverse events are: age 43: 1,831 reports, age 44: 1,578 reports, age 40: 836 reports, age 59: 649 reports, age 58: 424 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 Hydrochloride Allergy adverse event reports is Aurohealth 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 Cetirizine Hydrochloride Allergy include: Rheumatoid Arthritis, Systemic Lupus Erythematosus, Pemphigus, Rash, Off Label Use. 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 Hydrochloride Allergy 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 Hydrochloride Allergy has a safety concern score of 85 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. The majority of reactions are non-serious, but the serious reaction rate is high at 78.5%.
Key safety signals identified in Cetirizine Hydrochloride Allergy's adverse event data include: Rheumatoid arthritis and systemic lupus erythematosus are key safety signals.. Multiple reports of serious conditions like pericarditis and hepatic enzyme increased.. Drug intolerance and ineffectiveness are frequently reported.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Cetirizine hydrochloride allergy may interact with other drugs, and contraindicated products should be avoided. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Cetirizine Hydrochloride Allergy.
Consult a healthcare provider if experiencing severe or persistent side effects. Report any adverse reactions to the FDA's MedWatch program.
Cetirizine Hydrochloride Allergy has 341,924 adverse event reports on file with the FDA. A wide range of reactions are reported, indicating potential for diverse side effects. The volume of reports for Cetirizine Hydrochloride Allergy reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor cetirizine hydrochloride allergy for safety concerns, with ongoing reviews. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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