Hydroxyzine hydrochloride adverse event reports that FDA received

Name: Reaction terms in FDA adverse event reports that name Hydroxyzine hydrochloride
Creator: Reported Reactions
License: https://creativecommons.org/publicdomain/zero/1.0/

Name type: Generic name
Class: Antihistamine
Also reported as: Hydroxyzine Hydrochloride Tablets 25mg, Hydroxyzine Hydrochloride Tablets 50mg, Hydroxyzine Hydrochloride Tablets

What a report is

A report is not proof that the drug was the cause of the event.

FDA says:

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product.
Source: openFDA, Drug Adverse Event Overview, section "Responsible use of the data". The site read the page on 2 Oct 2026. The data have the reports that FDA received through 30 Jun 2026.

FDA also says:

There is no certainty that the reported event (adverse event or medication error) was actually due to the product. FDA does not require that a causal relationship between a product and event be proven, and reports do not always contain enough detail to properly evaluate an event. The information in these reports has not been scientifically or otherwise verified as to a cause and effect relationship and cannot be used to estimate the incidence of these events.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.
Source: openFDA, Response of the drug event API (meta.disclaimer). The site read the page on 2 Oct 2026.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

Drug reports received through 30 Jun 2026. Device reports have a separate cutoff, 30 Sep 2026. Why a report count is not a rate.

Reports on file

From January 2004 to June 2026, FDA received 2,500 adverse event reports that name Hydroxyzine hydrochloride. In these reports the drug is a suspect or interacting product.

In the same period, 10,691 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 417 reports in the 12 months to June 2026 and 269 in the 12 months before. FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

Of the 1,332,454 drug reports that FDA received in the 12 months to June 2026, 417 (under 0.1%) name Hydroxyzine hydrochloride. Reports from consumers or other non-health professionals were 16.2% of the reports that name Hydroxyzine hydrochloride and 45.8% of all drug reports.

The number of people who use the product is not in the data. A count is not a rate. A count of reports is not a count of events or of patients, because one event can have more than one report.

There are many instances of duplicative reports and some reports do not contain all the necessary information.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

Suspect product

FDA records each drug in a report as suspect, concomitant or interacting. This page counts the reports in which Hydroxyzine hydrochloride is suspect or interacting. FDA says:

Any number of the drugs may be marked as suspect if thought to be responsible for one or more of the reactions, but that information is not validated.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Data version

openFDA FAERS release of 29 Oct 2026. Reports received through 30 Jun 2026.

Since the last update

FDA says:

Many factors can influence whether or not an event will be reported, such as the time a product has been marketed and publicity about an event.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The information in these reports cannot be used to estimate the incidence (occurrence rates) of the events reported.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

The latest update of the FDA data, recorded on 28 Oct 2026, changed no count of this page.

In April to June 2026, FDA received 91 reports that name Hydroxyzine hydrochloride.
In January to March 2026, FDA received 152.
In April to June 2025, FDA received 58.

April to June 2026 is the latest closed quarter in the data. A closed quarter is a quarter for which the FDA files have most of the reports.

All updates Feed of updates (RSS)

Reaction lookup

These are the reaction terms that the reports record, with the number of reports for each term. Type a term or a plain word to find its count.

What this list leaves out

The table lists the 268 reaction terms that 5 or more reports record. A term with fewer than 5 reports is not in the table.

The site keeps reaction terms for 2,391 of the 2,500 reports (95.6%).

The reports of the other years are not in the counts.

So a count in the table can be lower than the count of FDA.

Find a reaction term

The table shows the first 50 of 268 terms.

Reaction terms in the reports that name Hydroxyzine hydrochloride, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 2,500 reports
Toxicity to various agentspoisoning or toxic effect of one or more substances	618	24.7%
Completed suicidedeath by suicide	425	17%
Drug abusemisuse of a medicine	246	9.8%
Drug ineffectivethe medicine did not work as expected	201	8%
Off label useused for a purpose or in a way not on the label	166	6.6%
Cardio-respiratory arrestthe heart and breathing stopped	148	5.9%
Somnolencedrowsiness	122	4.9%
Drug interactionan interaction between medicines	100	4%
Intentional overdosea deliberate overdose	97	3.9%
Hypotensionlow blood pressure	91	3.6%
Coma	79	3.2%
Overdosea dose above the recommended amount	79	3.2%
Falla fall	72	2.9%
Pruritusitching	72	2.9%
Vomitingbeing sick	63	2.5%
Electrocardiogram QT prolongeda QT prolongation on the ECG	59	2.4%
Deaththe patient died; cause not stated by this term	57	2.3%
Nauseafeeling sick	54	2.2%
Depressionlow mood	52	2.1%
Dyspnoeashortness of breath	50	2%
Malaisegeneral feeling of being unwell	47	1.9%
Rashskin rash	45	1.8%
Confusional stateconfusion	44	1.8%
Suicide attempta suicide attempt	44	1.8%
Cardiac arrestthe heart stopped	43	1.7%
Dizzinesslight-headedness or unsteadiness	43	1.7%
Intentional product misusedeliberate use not as intended	43	1.7%
Arthralgiajoint pain	42	1.7%
Tachycardiafast heart rate	42	1.7%
Condition aggravatedthe condition being treated got worse	39	1.6%
Serotonin syndrometoo much serotonin activity, with agitation, fever and tremor	39	1.6%
Drug ineffective for unapproved indication	38	1.5%
Headachehead pain	37	1.5%
Insomniadifficulty sleeping	36	1.4%
Anxiety	35	1.4%
Fatiguetiredness	34	1.4%
Poisoning	34	1.4%
Medication errora mistake in prescribing, dispensing or taking a medicine	33	1.3%
Osteoporosisthinning of the bones	33	1.3%
Painpain, site not specified	32	1.3%
Abdominal pain upperupper stomach pain	31	1.2%
Amnesiamemory loss	30	1.2%
Constipation	30	1.2%
Drug dependencedependence on a medicine	30	1.2%
Drug reaction with eosinophilia and systemic symptomsDRESS, a severe reaction with rash, fever and organ involvement	30	1.2%
Feeling abnormalfeeling odd or not right	30	1.2%
Poisoning deliberate	30	1.2%
Agitationrestlessness	29	1.2%
Sedationdrowsiness	29	1.2%
Urticariahives	29	1.2%

Download all 268 terms of Hydroxyzine hydrochloride (CSV)

The counts add to more than 2,500 reports, because one report can record more than one term. FDA says:

No individual drug is connected to any individual reaction. When a report lists multiple drugs and multiple reactions, there is no way to conclude from the data therein that a given drug is responsible for a given reaction.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The CSV file has the same rows and the same limits. Its last row is a note that says so.

MedDRA term

The person who codes a report selects the preferred term that agrees best with the description of the reporter. The words under a term are the plain meaning that this site gives.

Not the label

The FDA-approved label of a product lists its adverse reactions. See the official pages at the end of this page.

Same ingredient, other names

Reporters write a brand name or a generic name. Each name has its own page and its own count.

Names of Hydroxyzine with a page, in the order generic names, brand names, names as reported
Name	Name type	Reports
Hydroxyzine	Generic name	8,643
Hydroxyzine hydrochloride (this page)	Generic name	2,500

Sum of the separately reported names: 11,143. A report that names two of these names is in the sum two times. The sum is not the number of reports for the ingredient.

FDA says:

Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Importantly, the AEMS data by themselves are not an indicator of the safety profile of the drug or biologic.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

Outcomes by year

The table gives the outcomes that the reporters gave, in the terms of FDA.

Outcomes in the reports that name Hydroxyzine hydrochloride, by the year of the openFDA file that holds the report

The table continues to the right.

Year of the openFDA file	Reports	Serious	Death	Life-threatening	Hospitalization (initial or prolonged)	Disability or Permanent Damage	Congenital Anomaly/Birth Defect	Other Serious (Important Medical Events)	Not serious
2004	14	12	7	1	4	0	0	1	2
2005	9	8	2	1	5	0	1	0	1
2006	10	9	1	1	7	0	0	1	1
2007	29	24	11	1	9	0	0	7	5
2008	31	29	7	1	11	1	0	13	2
2009	10	10	9	1	0	0	0	1	0
2010	6	4	0	0	1	0	0	3	2
2011	17	15	3	2	9	0	0	8	2
2012	11	9	3	0	3	0	0	5	2
2013	15	7	0	0	3	1	0	3	8
2014	18	17	2	0	10	0	0	10	1
2015	43	35	12	4	8	0	0	26	8
2016	33	28	15	2	11	1	0	6	5
2017	85	67	52	2	19	0	0	10	18
2018	161	145	91	14	41	0	0	39	16
2019	153	149	93	8	33	0	1	34	4
2020	199	181	90	14	72	0	2	45	18
2021	176	158	76	11	60	1	0	63	18
2022	288	248	103	23	74	6	0	120	40
2023	357	310	124	33	99	5	0	192	47
2024	249	190	44	9	71	3	0	93	59
2025	329	223	62	24	104	12	5	124	106
2026	257	207	74	22	52	3	1	163	50

An outcome in a report is not proof that the drug was the cause. The reporter gives the outcome, and FDA does not verify it. FDA says:

The information in these reports has not been scientifically or otherwise verified as to a cause and effect relationship and cannot be used to estimate the incidence of these events.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The six headings with the names of FDA are the outcome terms of FDA. A report can have more than one outcome. The columns Serious and Not serious are the two values of the openFDA field serious. For the value serious, openFDA gives this description:

The adverse event resulted in death, a life threatening condition, hospitalization, disability, congenital anomaly, or other serious condition
Source: openFDA, Drug adverse event fields (YAML reference). The site read the page on 2 Oct 2026.

The year is the year of the openFDA file that holds the latest version of the report. It is not always the year in which FDA first received the report. The chart of the next section uses the year of first receipt. The latest year is not complete.

Reports by year and month

Reports that name Hydroxyzine hydrochloride, by the year in which FDA received them

The column of 2026 has an outline, because the year is not complete. It has the reports that FDA received through June 2026 only.

Show the figures of the chart as a table

Reports that name Hydroxyzine hydrochloride, by the year in which FDA received them
Year	Reports
2004	13
2005	9
2006	12
2007	26
2008	33
2009	11
2010	6
2011	20
2012	12
2013	16
2014	24
2015	44
2016	41
2017	86
2018	164
2019	149
2020	207
2021	183
2022	290
2023	356
2024	241
2025	314
2026	243

Reports that name Hydroxyzine hydrochloride, by month, five years to June 2026

FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

Why a count moves

A count moves for many reasons. The guide gives FDA's words about them.

Patients and reporters

Age of the patient in the reports that name Hydroxyzine hydrochloride
Age	Reports	Share
Under 2	17	0.7%
2 to 11	52	2.1%
12 to 17	112	4.5%
18 to 44	742	29.7%
45 to 64	624	25%
65 to 74	192	7.7%
75 and over	178	7.1%
Age not given	583	23.3%

Sex of the patient in the reports that name Hydroxyzine hydrochloride
Sex	Reports	Share
Female	1,313	52.5%
Male	827	33.1%
Unknown or not given	360	14.4%

Type of reporter in the reports that name Hydroxyzine hydrochloride
Reporter	Reports	Share
Physician	1,069	42.8%
Pharmacist	343	13.7%
Other health professional	608	24.3%
Lawyer	6	0.2%
Consumer or non-health professional	405	16.2%
Not given	69	2.8%

Age and sex are as the report gives them. The reporter is the primary source in the report. 60.3% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Hydroxyzine hydrochloride record
Indication as recorded (MedDRA)	Reports	Share
Anxiety	192	7.7%
Pruritus	86	3.4%
Insomnia	53	2.1%
Suicide attempt	19	0.8%
Chronic spontaneous urticaria	15	0.6%
Intentional overdose	14	0.6%

The reporter fills in the indication, and the field is often empty. Each share is of all 2,500 reports.

Drugs in the same reports

Other drugs that the reports of Hydroxyzine hydrochloride name, in any role, in order of name
Drug	Reports that name the two
Acetaminophen	176
Alcohol	135
Alprazolam	183
Cetirizine	105
Diazepam	123
Furosemide	141
Gabapentin	166
Oxazepam	102
Quetiapine	139
Trazodone	111

The table has the 10 drug names that these reports name most. Two names in one report says only that the report recorded the two. It says nothing about the part of a product in the event.

FDA says:

Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Importantly, the AEMS data by themselves are not an indicator of the safety profile of the drug or biologic.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

Pages near this one

Hydroxyzine same ingredient
Hydroxyzine hcl same class
Hydroxyzine pamoate same class
Unisom SleepTabs same class
Doxylamine succinate same class
Vicks NyQuil same class
Hygroton next in the A to Z list
Hydroxyurea next in the A to Z list
Hyoscine next in the A to Z list
Hydroxydaunorubicin next in the A to Z list
Hyoscyamine sulfate next in the A to Z list
Hydroxychloroquine Sulfate Plaquenil next in the A to Z list

These links are for navigation. No count selected them. The class page lists each drug of the class.

Official pages

DailyMed labels for Hydroxyzine hydrochlorideThe labels (prescribing information) that have this name, at the National Library of Medicine.
MedWatch Online Voluntary Reporting FormThe online form of FDA for a voluntary report.
MedWatch: The FDA Safety Information and Adverse Event Reporting ProgramThe page of the FDA program that receives reports about drugs and devices.
FDA Adverse Event Monitoring System (AEMS) Public DashboardThe public dashboard of FDA for adverse event reports on drugs and biologics.

The site checked these addresses on 2 Oct 2026. The links open in a new tab.

Cite this page

Reported Reactions. Hydroxyzine hydrochloride: adverse event reports that FDA received. https://reportedreactions.com/drug/hydroxyzine-hydrochloride/ Source: U.S. Food and Drug Administration, openFDA Drug Adverse Event (FAERS) files, release of 29 Oct 2026. Reports received through 30 Jun 2026.

Where the data come from

The counts come from the openFDA Drug Adverse Event (FAERS) bulk files, release of 29 Oct 2026. The files have the reports that FDA received through 30 Jun 2026. A drug name is the name on the report. The site matches it to a brand name or a generic name of the National Drug Code Directory of 2 Nov 2026. A class is the pharmacologic class (EPC) of the FDA label.

A report is in the count when it names Hydroxyzine hydrochloride as a suspect or interacting product. The 10,691 reports that name it only as a concomitant medicine are not in the count. The site does not publish a report narrative, a lot number, a detail of a patient or the identity of a reporter. The record of FDA is the authority. See how the site counts reports, the data sources and the corrections page.

Questions

Do these reports show that Hydroxyzine hydrochloride was responsible for the reactions?

No. FDA says:

For any given report, there is no certainty that a suspected drug caused the event.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

A reaction can relate to the condition that the drug treats, to other medicines, or to something else.

Is this the list of reactions on the label of Hydroxyzine hydrochloride?

No. It is a count of what people reported to FDA: 2,500 reports from January 2004 to June 2026. The FDA-approved label of a product lists its adverse reactions. The official pages at the end of this page link to the labels.

Who sent these reports?

Physician (42.8%), other health professional (24.3%) and consumer or non-health professional (16.2%). These are the types of reporter for the reports that name this drug.

If a manufacturer receives an adverse event report, it is normally required to send the report to FDA.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

How does a person report an adverse event?

FDA runs MedWatch, a program that takes voluntary reports from health professionals, patients and consumers. The guide on how to report has the links.

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