72/100 · Elevated
Manufactured by Kenvue Brands LLC
Cetirizine Hydrochloride Adverse Events Show High Fatigue and Rash Reports
615,076 FDA adverse event reports analyzed
Last updated: 2026-05-12
CETIRIZINE HYDROCHLORIDE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Kenvue Brands LLC. Based on analysis of 615,076 FDA adverse event reports, CETIRIZINE HYDROCHLORIDE has a safety score of 72 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 include DRUG INEFFECTIVE, FATIGUE, PAIN, OFF LABEL USE, RASH. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for CETIRIZINE HYDROCHLORIDE.
Cetirizine Hydrochloride has a safety concern score of 72 out of 100, placing it in the elevated concern category based on analysis of FDA adverse event data. The FDA has received approximately 615,076 adverse event reports for this medication, which is primarily manufactured by Kenvue Brands Llc.
The most commonly reported adverse events include Drug Ineffective, Fatigue, Pain. Of classified reports, 55.3% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Fatigue and rash are the most common adverse reactions reported.
The majority of adverse events are non-serious, but serious reactions are concerning. A wide range of reactions are reported, indicating diverse safety concerns.
Patients taking Cetirizine Hydrochloride should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Cetirizine Hydrochloride may interact with other drugs, and patients should be aware of potential side effects such as fatigue and rash. Consult a healthcare provider before combining with other medications. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Cetirizine Hydrochloride received a safety concern score of 72/100 (elevated concern). This is based on a 55.3% serious event ratio across 156,375 classified reports. The score accounts for 615,076 total adverse event reports and 100 distinct reaction types. This elevated score indicates a notable proportion of serious adverse events and warrants careful monitoring.
Adverse event reports by sex: Female: 98,471, Male: 38,695, Unknown: 151. The most frequently reported age groups are age 43 (3,213 reports), age 44 (3,211 reports), age 40 (2,070 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 156,375 classified reports for CETIRIZINE HYDROCHLORIDE:
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 may interact with other drugs, and patients should be aware of potential side effects such as fatigue and rash. Consult a healthcare provider before combining with other medications.
If you are taking Cetirizine Hydrochloride, here are important things to know. The most commonly reported side effects include drug ineffective, fatigue, pain, off label use, rash. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Monitor for signs of fatigue and rash, which are the most commonly reported side effects. Follow the prescribed dosage and consult a healthcare provider if you experience any unusual symptoms. 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 for safety. Patients should report any adverse reactions to the FDA's MedWatch program.
The FDA has received approximately 615,076 adverse event reports associated with Cetirizine Hydrochloride. 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 include Drug Ineffective, Fatigue, Pain, Off Label Use, Rash. By volume, the top reported reactions are: Drug Ineffective (20,910 reports), Fatigue (18,112 reports), Pain (15,413 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.
Out of 156,375 classified reports, 86,434 (55.3%) were classified as serious and 69,941 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 break down by patient sex as follows: Female: 98,471, Male: 38,695, Unknown: 151. 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 adverse events are: age 43: 3,213 reports, age 44: 3,211 reports, age 40: 2,070 reports, age 59: 2,050 reports, age 58: 1,814 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 adverse event reports is Kenvue Brands 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 include: Headache, Pruritus, Nausea, Dyspnoea, Abdominal Discomfort. 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 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 has a safety concern score of 72 out of 100 (elevated 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. Fatigue and rash are the most common adverse reactions reported.
Key safety signals identified in Cetirizine Hydrochloride's adverse event data include: Frequent reports of fatigue and rash suggest potential side effects.. A high number of serious reactions, particularly respiratory issues, indicate significant safety concerns.. A diverse range of reactions, including serious conditions like pericarditis and pneumonia, are reported.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Cetirizine Hydrochloride may interact with other drugs, and patients should be aware of potential side effects such as fatigue and rash. Consult a healthcare provider before combining with other medications. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Cetirizine Hydrochloride.
Monitor for signs of fatigue and rash, which are the most commonly reported side effects. Follow the prescribed dosage and consult a healthcare provider if you experience any unusual symptoms.
Cetirizine Hydrochloride has 615,076 adverse event reports on file with the FDA. The majority of adverse events are non-serious, but serious reactions are concerning. The volume of reports for Cetirizine Hydrochloride reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor cetirizine hydrochloride for safety. Patients 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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