Cetirizine Hydrochloride
According to the FDA label: Perennial Allergic Rhinitis Cetirizine hydrochloride oral solution, USP is indicated for the relief of symptoms associated with perennial allergic rhinitis due to allergens such as dust mites, animal dander and molds in children 6 to 23 months of age. Symptoms treated effectively include sneezing, rhinorrhea, postnasal discharge, nasal pruritus, ocular pruritus, and tearing.
67,119 adverse event reports submitted to the FDA (2004–2026)
Top Reported Adverse Events
The most frequently reported events in association with Cetirizine Hydrochloride in the FAERS database. These are events reported by patients taking this medication, not necessarily caused by it. A single report may include multiple events.
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Drug Ineffective 12,922 reports
A report that the medication did not work as expected for the person taking it. This is a reporting category, not a sign the drug is defective. It simply means someone felt it was not helping their condition.
Full definition in the glossary →Fatigue 12,582 reports
Extreme tiredness or lack of energy that does not improve with rest.
Full definition in the glossary → See all drugs reporting this event →Pain 11,990 reports
A general report of physical discomfort, used when no more specific location is given.
Full definition in the glossary →Rash 9,692 reports
An area of irritated, red, or bumpy skin.
Full definition in the glossary → See all drugs reporting this event →Off Label Use 9,364 reports
Using a medication for a condition or in a way that the FDA has not officially approved. This is common and often legal, and a report of it does not mean something went wrong. Doctors sometimes prescribe drugs off label based on their judgment.
Full definition in the glossary →Abdominal Discomfort 9,349 reports
A general unease or mild pain in the belly area.
Full definition in the glossary →Alopecia 9,299 reports
Rheumatoid Arthritis 8,785 reports
An autoimmune condition where the immune system attacks the joints, causing pain and swelling. It often appears in reports because it is a condition being treated, not always a reaction.
Full definition in the glossary →Systemic Lupus Erythematosus 8,568 reports
An autoimmune condition, often called lupus, where the immune system attacks the body's own tissues, affecting joints, skin, and organs. It often appears in reports because it is a condition being treated, not always a reaction.
Full definition in the glossary →Pemphigus 8,386 reports
A rare autoimmune condition that causes blistering of the skin and the moist linings of the body such as the mouth.
Full definition in the glossary →Swelling 7,975 reports
A general report of a body part becoming enlarged, often from fluid or inflammation.
Full definition in the glossary →Glossodynia 7,865 reports
Pain or a burning sensation in the tongue.
Full definition in the glossary →Hypersensitivity 7,782 reports
An exaggerated reaction by the immune system, similar to an allergic reaction.
Full definition in the glossary →Arthralgia 7,402 reports
Pruritus 7,309 reports
Ranked by frequency of reports, not severity. The most-reported event is not necessarily the most dangerous or the most common in patients taking this drug.
Who Is Reporting
Demographics of patients in FAERS reports that included this information. Not all reports include patient demographics.
By Sex
View reporter sex data as a table
| Sex | Reports |
|---|---|
| Female | 41,272 |
| Male | 16,347 |
| Unknown | 52 |
By Age Group
View age group data as a table
| Age group | Reports |
|---|---|
| 0-17 | 4,268 |
| 18-34 | 5,199 |
| 35-49 | 12,474 |
| 50-64 | 10,766 |
| 65-74 | 7,138 |
| 75+ | 5,460 |
This shows who filed reports, reflecting who takes this drug and who tends to report, not who is at greatest risk.
Reported Outcomes
Outcomes recorded in FAERS reports that included Cetirizine Hydrochloride. A single report may involve multiple reactions, each with a different outcome. These categories are defined by FDA reporting guidelines, not by PillSignal.
View outcome data as a table
| Outcome | Reports |
|---|---|
| Other Serious | 40,108 |
| Hospitalization | 21,744 |
| Non-Serious | 14,722 |
| Disability | 8,646 |
| Death | 7,847 |
| Life-Threatening | 7,815 |
Serious outcomes are far more likely to be reported than mild ones, so this overstates how often outcomes are serious. A recorded death does not mean the drug caused it.
Report Volume Over Time
Number of FAERS reports received per quarter for Cetirizine Hydrochloride. Changes in volume may reflect shifts in prescribing rates, media attention, or reporting behavior, not changes in the medication's safety profile.
View report trend as a table
| Year | Reports |
|---|---|
| 2004 | 24 |
| 2005 | 68 |
| 2006 | 54 |
| 2007 | 67 |
| 2008 | 183 |
| 2009 | 309 |
| 2010 | 190 |
| 2011 | 276 |
| 2012 | 736 |
| 2013 | 939 |
| 2014 | 1,430 |
| 2015 | 2,007 |
| 2016 | 2,828 |
| 2017 | 2,925 |
| 2018 | 3,837 |
| 2019 | 4,737 |
| 2020 | 5,691 |
| 2021 | 8,213 |
| 2022 | 7,588 |
| 2023 | 6,787 |
| 2024 | 8,202 |
| 2025 | 8,253 |
| 2026 (partial) | 1,775 |
The steep increase around 2004 reflects the FDA's move to electronic submission, not a change in this drug's safety. Trends track reporting volume, not risk.
Medications commonly reported with Cetirizine Hydrochloride
In FDA adverse event reports that mention Cetirizine Hydrochloride, these medications appeared most often in the same report.
- Cetirizine Allergy (29,428 reports)
- Prednisone (18,097 reports)
- Acetaminophen (17,785 reports)
- Methotrexate (14,378 reports)
- Folic Acid (14,341 reports)
This reflects co-occurrence in submitted reports, not evidence of drug interaction or combined risk. People often report several medications taken for the same condition or for unrelated reasons. Talk to a doctor or pharmacist about your specific medications.
Related Drugs
Other medications with similar adverse event profiles in FDA FAERS reports.
Data Source
This data is sourced from the FDA's Adverse Event Monitoring System (AEMS), formerly FAERS, via the OpenFDA API. PillSignal is not affiliated with the FDA.
View this data on the FDA website →Data last updated: June 2026