85/100 · Critical
Manufactured by Amneal Pharmaceuticals LLC
Cetirizine Adverse Reactions: High Seriousness and Diverse Reactions
233,494 FDA adverse event reports analyzed
Last updated: 2026-05-12
CETIIRIZINE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Amneal Pharmaceuticals LLC. Based on analysis of 233,494 FDA adverse event reports, CETIIRIZINE 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 CETIIRIZINE include FATIGUE, DRUG INEFFECTIVE, PAIN, RASH, DYSPNOEA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for CETIIRIZINE.
Cetiirizine 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 233,494 adverse event reports for this medication, which is primarily manufactured by Amneal Pharmaceuticals Llc.
The most commonly reported adverse events include Fatigue, Drug Ineffective, Pain. Of classified reports, 79.9% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Fatigue and pain are the most common reactions, with a significant number of serious adverse events reported.
A wide range of reactions, including respiratory, gastrointestinal, and musculoskeletal issues, are observed. The drug is frequently reported to be ineffective, and there are concerns about drug intolerance and hypersensitivity. There are notable reports of serious conditions such as systemic lupus erythematosus and pericarditis. The majority of adverse events are non-serious, but the high percentage of serious events is a cause for concern.
Patients taking Cetiirizine should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Cetirizine may interact with other medications, and patients should be aware of potential drug intolerance and hypersensitivity reactions. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Cetiirizine received a safety concern score of 85/100 (high concern). This is based on a 79.9% serious event ratio across 39,675 classified reports. The score accounts for 233,494 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: 23,901, Male: 11,046, Unknown: 30. The most frequently reported age groups are age 44 (1,625 reports), age 43 (1,191 reports), age 40 (626 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 39,675 classified reports for CETIIRIZINE:
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 may interact with other medications, and patients should be aware of potential drug intolerance and hypersensitivity reactions.
If you are taking Cetiirizine, here are important things to know. The most commonly reported side effects include fatigue, drug ineffective, pain, rash, dyspnoea. 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 you experience persistent or severe side effects. Do not stop taking cetirizine without consulting your doctor, as this could worsen your condition. 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 healthcare providers should be vigilant about serious adverse events and consider alternative treatments if necessary.
The FDA has received approximately 233,494 adverse event reports associated with Cetiirizine. 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 Cetiirizine include Fatigue, Drug Ineffective, Pain, Rash, Dyspnoea. By volume, the top reported reactions are: Fatigue (5,414 reports), Drug Ineffective (4,954 reports), Pain (4,810 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Cetiirizine.
Out of 39,675 classified reports, 31,700 (79.9%) were classified as serious and 7,975 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 Cetiirizine break down by patient sex as follows: Female: 23,901, Male: 11,046, Unknown: 30. 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 Cetiirizine adverse events are: age 44: 1,625 reports, age 43: 1,191 reports, age 40: 626 reports, age 68: 570 reports, age 67: 561 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 Cetiirizine adverse event reports is Amneal Pharmaceuticals 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 Cetiirizine include: Pruritus, Off Label Use, Arthralgia, Pyrexia, Hypersensitivity. 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 Cetiirizine 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.
Cetiirizine 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. Fatigue and pain are the most common reactions, with a significant number of serious adverse events reported.
Key safety signals identified in Cetiirizine's adverse event data include: High percentage of serious adverse events (79.9%). Diverse range of reactions including respiratory, gastrointestinal, and musculoskeletal issues. Frequent reports of drug ineffectiveness and intolerance. Reports of serious conditions such as systemic lupus erythematosus and pericarditis. Significant number of reports related to infections and respiratory tract issues. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Cetirizine may interact with other medications, and patients should be aware of potential drug intolerance and hypersensitivity reactions. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Cetiirizine.
Consult a healthcare provider if you experience persistent or severe side effects. Do not stop taking cetirizine without consulting your doctor, as this could worsen your condition.
Cetiirizine has 233,494 adverse event reports on file with the FDA. A wide range of reactions, including respiratory, gastrointestinal, and musculoskeletal issues, are observed. The volume of reports for Cetiirizine reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor cetirizine for safety, and healthcare providers should be vigilant about serious adverse events and consider alternative treatments if necessary. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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