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Hydroxyzine Side Effects

The most commonly reported side effects of hydroxyzine include pruritus, fatigue, and nausea, based on 75,163 FDA adverse event reports from 2004 to 2025. 5.3% of reports found the drug to be ineffective.

Hydroxyzine side effects

Percentages show how often each reaction appears relative to total reports for hydroxyzine.

1
Pruritus5.5%4,148
2
Drug Ineffective5.3%4,019
3
Fatigue5.1%3,827
4
Nausea5.0%3,759
5
Off Label Use4.3%3,269
6
Headache4.0%3,035
7
Pain3.9%2,965
8
Toxicity To Various Agents3.7%2,808
9
Rash3.6%2,715
10
Diarrhoea3.5%2,655
11
Anxiety3.3%2,508
12
Dyspnoea3.3%2,490
13
Vomiting3.1%2,356
14
Dizziness2.9%2,194
15
Completed Suicide2.9%2,182

These are voluntary reports and do not establish that hydroxyzine caused these reactions.

Report severity

69.6%Serious52,312 reports
35.7%Hospitalizations26,807 reports
12.7%Fatal9,541 reports

Seriousness is determined by the reporter, not by OpenClaim.

Hydroxyzine drug interactions

Other drugs that appear in adverse event reports alongside hydroxyzine. Drugs flagged as a suspected cause appear in the first column. Drugs taken at the same time but not suspected appear in the second.

Also suspected

1
Dupilumab6.7%5,048
2
Quetiapine-fumarate3.0%2,280
3
Acetaminophen2.8%2,106
4
Sodium-oxybate2.8%2,082
5
Omalizumab2.8%2,075
6
Omeprazole2.4%1,833
7
Adalimumab2.3%1,744
8
Gabapentin2.1%1,592
9
Esomeprazole2.0%1,525
10
Lenalidomide2.0%1,483
11
Sertraline-hydrochloride1.9%1,435
12
Tramadol-hydrochloride1.9%1,419
13
Pantoprazole-sodium1.8%1,365
14
Alprazolam1.7%1,289
15
Pregabalin1.6%1,222

Taken alongside

1
Acetaminophen18.2%13,685
2
Albuterol13.2%9,933
3
Gabapentin12.6%9,453
4
Ergocalciferol11.8%8,876
5
Omeprazole11.5%8,643
6
Levothyroxine-sodium11.0%8,250
7
Aspirin10.2%7,636
8
Furosemide9.7%7,280
9
Prednisone9.6%7,228
10
Ondansetron9.4%7,057
11
Fluticasone9.2%6,910
12
Atorvastatin-calcium8.5%6,411
13
Cetirizine-hydrochloride7.7%5,817
14
Amlodipine7.7%5,763
15
Pantoprazole-sodium7.6%5,685

Co-occurrence in adverse event reports does not establish a drug interaction. Patients often take multiple medications, and these lists reflect prescribing patterns rather than causal relationships. Consult a healthcare provider about potential drug interactions.

Who reports hydroxyzine side effects

60.6% of hydroxyzine adverse event reports involve female patients and 31.7% involve male patients. The largest age group is adult at 67%. These figures reflect who reports side effects, not underlying risk.

Sex

Female60.6%
Male31.7%
Unknown7.6%

Age group

< 20.8%
2–113.0%
12–173.8%
18–6466.7%
65+25.7%

What is hydroxyzine used for

Conditions and purposes for which patients were taking hydroxyzine when the adverse event was reported.

Abdominal DiscomfortAbdominal PainAbdominal Pain UpperAbnormal BehaviourAbnormal DreamsAcarodermatitisAccidental Exposure To ProductAcneAcute Coronary SyndromeAcute Graft Versus Host DiseaseAcute Lymphocytic LeukaemiaAcute Pulmonary OedemaAdjustment DisorderAdjustment Disorder With Depressed MoodAdjuvant Therapy

Showing 15 of 1,078 indications

Hydroxyzine brand names and reporting trend

Hydroxyzine is sold under brand names including Vistaril, Orgatrax.

Brand names

Vistaril3,919
Orgatrax551

Quarterly reports (20042025)

20052010201520202025

An upward trend reflects increased FAERS reporting overall, not necessarily increased risk.

Taking hydroxyzine with another medication?

Ask OpenClaim about your specific drug combination. Get a sourced report using FDA data, drug labels, and medical literature.