85/100 · Critical
Manufactured by Dr. Reddy's Laboratories Inc.
Cetirizine Hydrochloride Tablets: High Serious Reaction Rate and Diverse Safety Concerns
341,923 FDA adverse event reports analyzed
Last updated: 2026-05-12
CETIRIZINE HYDROCHLORIDE TABLETS is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Dr. Reddy's Laboratories Inc.. Based on analysis of 341,923 FDA adverse event reports, CETIRIZINE HYDROCHLORIDE TABLETS 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 TABLETS 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 TABLETS.
Cetirizine Hydrochloride Tablets 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 341,923 adverse event reports for this medication, which is primarily manufactured by Dr. Reddy'S Laboratories Inc..
The most commonly reported adverse events include Drug Ineffective, Pain, Fatigue. Of classified reports, 78.4% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. High percentage of serious adverse events (78.4%) indicates significant safety concerns.
A wide range of reactions, including systemic lupus erythematosus and pericarditis, suggest diverse safety issues. Report volume is substantial, with over 340,000 total reports, providing a comprehensive dataset for analysis.
Patients taking Cetirizine Hydrochloride Tablets should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Cetirizine Hydrochloride Tablets may interact with other medications, and there are warnings against off-label use and contraindicated products. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Cetirizine Hydrochloride Tablets received a safety concern score of 85/100 (high concern). This is based on a 78.4% serious event ratio across 28,581 classified reports. The score accounts for 341,923 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: 18,818, Male: 4,987, 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 28,581 classified reports for CETIRIZINE HYDROCHLORIDE TABLETS:
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 Tablets may interact with other medications, and there are warnings against off-label use and contraindicated products.
If you are taking Cetirizine Hydrochloride Tablets, 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. Always consult a healthcare provider before starting or stopping cetirizine hydrochloride tablets, especially if you have a history of autoimmune diseases or cardiovascular conditions. Report any adverse reactions to the FDA's MedWatch program to help improve safety monitoring. 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 tablets for safety, and regulatory actions may be taken based on ongoing data.
The FDA has received approximately 341,923 adverse event reports associated with Cetirizine Hydrochloride Tablets. 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 Tablets include Drug Ineffective, Pain, Fatigue, Alopecia, Abdominal Discomfort. By volume, the top reported reactions are: Drug Ineffective (9,071 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 Tablets.
Out of 28,581 classified reports, 22,417 (78.4%) were classified as serious and 6,164 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 Tablets break down by patient sex as follows: Female: 18,818, Male: 4,987, 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 Tablets 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 Tablets adverse event reports is Dr. Reddy'S Laboratories 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 Cetirizine Hydrochloride Tablets include: Rheumatoid Arthritis, Systemic Lupus Erythematosus, Pemphigus, Off Label Use, 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 Cetirizine Hydrochloride Tablets 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 Tablets 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. High percentage of serious adverse events (78.4%) indicates significant safety concerns.
Key safety signals identified in Cetirizine Hydrochloride Tablets's adverse event data include: Systemic lupus erythematosus and rheumatoid arthritis are key safety signals.. Multiple reports of serious cardiovascular events, including pericarditis and hypertension.. Significant number of reports involving gastrointestinal issues, such as abdominal discomfort and duodenal ulcer perforation.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Cetirizine Hydrochloride Tablets may interact with other medications, and there are warnings against off-label use and contraindicated products. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Cetirizine Hydrochloride Tablets.
Always consult a healthcare provider before starting or stopping cetirizine hydrochloride tablets, especially if you have a history of autoimmune diseases or cardiovascular conditions. Report any adverse reactions to the FDA's MedWatch program to help improve safety monitoring.
Cetirizine Hydrochloride Tablets has 341,923 adverse event reports on file with the FDA. A wide range of reactions, including systemic lupus erythematosus and pericarditis, suggest diverse safety issues. The volume of reports for Cetirizine Hydrochloride Tablets reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor cetirizine hydrochloride tablets for safety, and regulatory actions may be taken based on ongoing data. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
Explore other medications manufactured by Dr. Reddy's Laboratories Inc. and compare their safety profiles:
The following drugs share commonly reported adverse reactions with CETIRIZINE HYDROCHLORIDE TABLETS:
Drugs related to CETIRIZINE HYDROCHLORIDE TABLETS based on therapeutic use, drug class, or shared indications: