Ataraxhydroxyzine
According to the FDA label: The total management of anxiety, tension, and psychomotor agitation in conditions of emotional stress requires in most instances a combined approach of psychotherapy and chemotherapy.
45,845 adverse event reports submitted to the FDA (2003–2026)
Top Reported Adverse Events
The most frequently reported events in association with Atarax 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.
Show these terms with plain-language definitions
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Drug Ineffective 3,099 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 →Pruritus 3,069 reports
Nausea 2,725 reports
The feeling of sickness in your stomach that often comes before vomiting.
Full definition in the glossary → See all drugs reporting this event →Fatigue 2,672 reports
Extreme tiredness or lack of energy that does not improve with rest.
Full definition in the glossary → See all drugs reporting this event →Toxicity to Various Agents 2,455 reports
A broad reporting category used when the body has a harmful response, sometimes involving more than one substance.
Full definition in the glossary →Off Label Use 2,354 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 →Pain 2,254 reports
A general report of physical discomfort, used when no more specific location is given.
Full definition in the glossary →Completed Suicide 2,226 reports
A report that a person died by suicide. This is recorded in adverse event data when it occurs during medication use, and its presence does not establish that the drug was the cause. If you or someone you know is struggling, the 988 Suicide and Crisis Lifeline (call or text 988 in the US) is available 24 hours a day.
Full definition in the glossary →Headache 2,210 reports
Pain in the head or upper neck.
Full definition in the glossary → See all drugs reporting this event →Rash 2,049 reports
An area of irritated, red, or bumpy skin.
Full definition in the glossary → See all drugs reporting this event →Diarrhoea 1,932 reports
Loose or watery bowel movements, often frequent. Also spelled diarrhea in American English.
Full definition in the glossary → See all drugs reporting this event →Dyspnoea 1,904 reports
Shortness of breath or difficulty breathing. Also spelled dyspnea in American English.
Full definition in the glossary → See all drugs reporting this event →Anxiety 1,870 reports
A feeling of worry, nervousness, or unease.
Full definition in the glossary → See all drugs reporting this event →Vomiting 1,716 reports
Throwing up the contents of the stomach.
Full definition in the glossary → See all drugs reporting this event →Dizziness 1,604 reports
A feeling of being lightheaded, unsteady, or like the room is spinning.
Full definition in the glossary → See all drugs reporting this event →
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 | 27,620 |
| Male | 14,037 |
| Unknown | 66 |
By Age Group
View age group data as a table
| Age group | Reports |
|---|---|
| 0-17 | 2,631 |
| 18-34 | 5,201 |
| 35-49 | 6,675 |
| 50-64 | 9,218 |
| 65-74 | 4,801 |
| 75+ | 2,968 |
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 Atarax. 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 | 18,749 |
| Non-Serious | 15,590 |
| Hospitalization | 14,223 |
| Death | 6,698 |
| Life-Threatening | 2,228 |
| Disability | 1,018 |
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 Atarax. 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 |
|---|---|
| 2003 | 1 |
| 2004 | 273 |
| 2005 | 373 |
| 2006 | 302 |
| 2007 | 295 |
| 2008 | 359 |
| 2009 | 493 |
| 2010 | 597 |
| 2011 | 675 |
| 2012 | 837 |
| 2013 | 984 |
| 2014 | 1,235 |
| 2015 | 1,837 |
| 2016 | 1,819 |
| 2017 | 2,063 |
| 2018 | 2,844 |
| 2019 | 3,349 |
| 2020 | 3,319 |
| 2021 | 3,446 |
| 2022 | 4,418 |
| 2023 | 4,733 |
| 2024 | 4,684 |
| 2025 | 5,432 |
| 2026 (partial) | 1,477 |
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 Atarax
In FDA adverse event reports that mention Atarax, these medications appeared most often in the same report.
- Gabapentin (7,288 reports)
- Acetaminophen (6,238 reports)
- Omeprazole (6,174 reports)
- Ergocalciferol (5,437 reports)
- Albuterol (5,170 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