Prescription medication · Antihistamine / Anxiolytic
hydroxyzine
Also sold as Vistaril, Atarax. Hydroxyzine is used to relieve anxiety and tension, especially when related to mental health conditions or other illnesses.
Data updated 2026-05-15
- 44,206
- FDA reportsOften reported
- 1
- InteractionFew interactions
- $0.17
- Generic price (NADAC)
What the data shows
hydroxyzine (Vistaril) is a prescription Antihistamine / Anxiolytic, reported at a middle-of-the-pack volume (44,206 FDA reports), with 1 documented drug interaction.
Reporting volume reflects how widely a drug is used and studied, not how dangerous it is, a FAERS report documents a temporal association, never proof of cause.
hydroxyzine (Vistaril) is a prescription Antihistamine / Anxiolytic. Hydroxyzine is used to relieve anxiety and tension, especially when related to mental health conditions or other illnesses.
Hydroxyzine is an antihistamine that can also help with anxiety. It works by reducing the effects of histamine, a substance in the body that can cause allergic symptoms.
Verify with FDA → · CMS NADAC pricing →
Drug Pricing (NADAC)
Generic Price
$0.17/unit
Generic Available
Yes (27 manufacturers)
Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →
What it does
Hydroxyzine is used to relieve anxiety and tension, especially when related to mental health conditions or other illnesses.
Common side effects
Dry mouth, Drowsiness
Key warnings
You should not take this medicine if you are pregnant, especially in early pregnancy, as it may harm the baby.
The sections below are summarized in plain English from hydroxyzine's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.
How It Works
Hydroxyzine blocks histamine, a natural substance your body makes during an allergic reaction. By blocking histamine, it helps reduce itching and other allergy symptoms. It also has a calming effect on the brain, which helps reduce anxiety.
Side Effects (from patient reports)
Based on 44,206 FDA adverse event reports.
Most-reported reactions
Adverse reactions in FAERS for hydroxyzine, by number of reports
- Pruritus
Pruritus
2,965 reports
- Nausea
Nausea
2,612 reports
- Fatigue
Fatigue
2,605 reports
- Toxicity To Various Agents
Toxicity To Various Agents
2,302 reports
- Pain
Pain
2,188 reports
- Headache
Headache
2,140 reports
- Completed Suicide
Completed Suicide
2,064 reports
- Rash
Rash
1,990 reports
- Diarrhoea
Diarrhoea
1,859 reports
- Dyspnoea
Dyspnoea
1,844 reports
What this shows Bars show how often each reaction was reported, not how likely it is to happen, a report records a temporal association, never proof that the drug caused it.
Reports over time
Adverse-event reports filed for hydroxyzine each year to the FDA Adverse Event Reporting System (FAERS).
Year-to-year volume tracks usage, prescribing, and scrutiny, not a change in per-patient risk. Source: FDA FAERS.
Where hydroxyzine sits
hydroxyzine has more FDA adverse-event reports than 71% of the drugs FAERS tracks. A high position reflects how widely a drug is used and watched, not how dangerous it is.
Percentile across all drugs PlainMeds tracks by FAERS report volume. The dot is hydroxyzine; the line is the median (50th percentile).
FDA Adverse Event Report Analysis
Detailed analysis of 44,206 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2003–2025.
Total Reports
44,206
Reports Mentioning Death
6,351
14.4% of reports — not proof of cause
Hospitalization Reports
13,813
Top Indication
Product Used For Unknown Indication
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 2 | PRURITUS | 2,965 |
| 3 | NAUSEA | 2,612 |
| 4 | FATIGUE | 2,605 |
| 5 | TOXICITY TO VARIOUS AGENTS | 2,302 |
| 7 | PAIN | 2,188 |
| 8 | HEADACHE | 2,140 |
| 9 | COMPLETED SUICIDE | 2,064 |
| 10 | RASH | 1,990 |
| 11 | DIARRHOEA | 1,859 |
| 12 | DYSPNOEA | 1,844 |
| 13 | ANXIETY | 1,799 |
| 14 | VOMITING | 1,631 |
| 15 | DIZZINESS | 1,555 |
| 16 | URTICARIA | 1,390 |
| 17 | FALL | 1,328 |
Reactions in Death Reports
Reactions in Hospitalization Reports
Source: FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation
Serious Warnings
You should not take this medicine if you are pregnant, especially in early pregnancy, as it may harm the baby. Also, do not take hydroxyzine if you have a heart condition called prolonged QT interval or if you are allergic to hydroxyzine, cetirizine, or levocetirizine.
Known Drug Interactions
No significant adverse interactions with commonly used premedications or drugs used during anesthesia and surgery (including atropine, scopolamine, glycopyrrolate, diazepam, hydroxyzine, d-tubocurarine, succinylcholine and other nondepolarizing muscle relaxants) or topical local anesthetics (including lidocaine, dyclonine HCl and Cetacaine) have been observed in adults or pediatric patients.
Mechanism: There are no known harmful effects when these two medications are used at the same time.
This is a plain-language summary of FDA-label interaction records and does not provide individual medication-combination directions.
Common Questions
Can I drive while taking hydroxyzine?
Can I drink alcohol while taking hydroxyzine?
How long does it take for hydroxyzine to work?
Can I take hydroxyzine long-term?
What should I do if I overdose?
Can children take hydroxyzine?
Does hydroxyzine interact with other medications?
Can hydroxyzine cause weight gain?
Is hydroxyzine addictive?
What are the inactive ingredients in hydroxyzine capsules?
What are the common side effects of hydroxyzine?
Does hydroxyzine interact with other medications?
What drug class is hydroxyzine?
What pregnancy or breastfeeding source fields are listed for hydroxyzine?
Related Medications in Antihistamine / Anxiolytic
Other drugs grouped near hydroxyzine - same-class peers and common alternatives.
azelastine
Astelin, Astepro
Azelastine nasal spray is an antihistamine medicine.
Compare with hydroxyzine →
budesonide nasal
Rhinocort
Rhinocort is a nasal spray that helps relieve allergy symptoms.
Compare with hydroxyzine →
cetirizine
Zyrtec
Cetirizine (Zyrtec) is an antihistamine medicine.
Compare with hydroxyzine →
chlorpheniramine
Chlor-Trimeton
Chlorpheniramine is an antihistamine medicine.
Compare with hydroxyzine →
ciclesonide nasal
Omnaris, Zetonna
Omnaris Nasal Spray is a medicine that helps treat allergy symptoms in your nose.
Compare with hydroxyzine →
Compare beyond drug class
Nationwide peers by FAERS volume & death-report share
Two PlainMeds-derived comparison paths for hydroxyzine: nearest FDA FAERS report volume and nearest death-report share among drugs with at least 1,000 logged reports, excluding same-class neighbors listed above. Counts reflect reporting volume, not proven individual harm.
Similar FAERS report volume
Nearest drugs by total FAERS reports. This record: 44,206.
Similar death-report share
Nearest drugs by FAERS death-report share. This record: 14.37%.
- lorazepam Δ 0.03 pts · 174,469 reports · Benzodiazepine 14.34%death share
- phenytoin Δ 0.05 pts · 20,453 reports · Anticonvulsant (Hydantoin) 14.42%death share
- venlafaxine Δ 0.07 pts · 68,147 reports · Serotonin-Norepinephrine Reuptake Inhibitor (SNRI) 14.30%death share
- triazolam Δ 0.07 pts · 8,521 reports · Benzodiazepine (Hypnotic) 14.29%death share
Medication Guides
Understanding Drug Interactions
How CYP450 enzymes, inhibitors, and inducers affect your medications
Generic vs Brand Name Drugs
FDA requirements, cost savings, and when the difference matters
Narrow Therapeutic Index Drugs
FDA bioequivalence and label-record context for narrow therapeutic index medicines
Common Drug Interactions
Dangerous medication combinations and how to protect yourself
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What the FDA Data Shows for hydroxyzine
The FDA label for hydroxyzine (sold under brand names such as Vistaril, Atarax) classifies it as a prescription-only medication in the Antihistamine / Anxiolytic class. Hydroxyzine is used to relieve anxiety and tension, especially when related to mental health conditions or other illnesses. Official labeling lists 2 commonly reported side effects, including Dry mouth, Drowsiness.
Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 44,206 voluntary reports. The database also lists 1 documented drug interaction derived from FDA labeling, with the top-flagged interaction rated minor severity. NADAC pricing from CMS shows a generic unit cost of $0.17.
Report counts do not establish causation, a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history, and patent information are separate source-record fields. This page is a public FDA/CMS registry and does not provide medical, treatment, substitution, or medication-change directions.
Data Sources
Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS). Pricing: CMS National Average Drug Acquisition Cost (NADAC).
FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. This registry does not provide medication decisions.
Last updated: December 16, 2024
PlainMeds is rendered directly from FDA openFDA/FAERS extracts, DailyMed labels, and CMS drug-pricing files, no number is typed in by an editor. FAERS counts, recalls, shortages, and price figures on this page are queried live from those federal extracts. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of 2026-05-15. Primary sources: openFDA / FAERS, DailyMed and CMS Part B ASP.
Read our methodology - how this data is sourced, computed, and verified.
Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled from the source snapshot dated . See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a data issue.
All federal data sources used on this page
- FDA Orange Book - approved drug products with therapeutic equivalence. accessdata.fda.gov/cder/ob
- FDA DailyMed - NIH-hosted drug labeling for FDA-approved meds. dailymed.nlm.nih.gov
- FDA Adverse Event Reporting System (FAERS) - post-marketing safety surveillance. fda.gov/drugs/faers
- NLM RxNorm - standardized clinical drug nomenclature. nlm.nih.gov/research/umls/rxnorm
- CMS Medicare Part B Drug Average Sales Price Files - federal drug pricing data. cms.gov/medicare/part-b-drugs/asp
- FDA Drug Shortages Database - current and resolved drug shortage tracking. accessdata.fda.gov/drugshortages