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.
How to Take It
Take hydroxyzine exactly as your doctor tells you to. For anxiety, adults usually take 50 mg to 100 mg four times a day. Children's doses are lower and depend on their age. You can take this medicine with or without food.
This is a plain-language summary of hydroxyzine's FDA labeling, not individualized dosing advice. Ask a pharmacist or prescriber before changing how you take this medication.
Pregnancy & Breastfeeding
Do not take hydroxyzine if you are pregnant, especially in early pregnancy. It may cause harm to your unborn baby. Talk to your doctor if you are breastfeeding before taking this medicine.
This is a plain-language summary of hydroxyzine's FDA labeling, not individualized advice. Ask a pharmacist or prescriber about pregnancy or breastfeeding on this medication.
Missed Dose
If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and continue with your regular schedule.
This is a plain-language summary of hydroxyzine's FDA labeling, not individualized advice. Ask a pharmacist or prescriber what to do about your specific missed dose.
Storage
Store hydroxyzine at room temperature (68° to 77°F) and protect it from moisture.
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
- Itching
Itching
2,967 reports
- Feeling sick to your stomach
Feeling sick to your stomach
2,614 reports
- Feeling tired
Feeling tired
2,607 reports
- Harm from other substances
Harm from other substances
2,302 reports
- Pain
Pain
2,188 reports
- Headache
Headache
2,141 reports
- Suicide
Suicide
2,064 reports
- Skin rash
Skin rash
1,991 reports
- Diarrhea
Diarrhea
1,861 reports
- Difficulty breathing
Difficulty breathing
1,846 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) 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.
What to do: These drugs can be used together safely without needing to change the dose.
This is a plain-language summary of interactions documented in FDA labeling, not individualized advice. Ask a pharmacist or prescriber before combining medications.
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?
Is hydroxyzine safe during pregnancy?
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 →
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
Why some drugs demand precise dosing and monitoring
Common Drug Interactions
Dangerous medication combinations and how to protect yourself
Save on hydroxyzine
Compare prices and find discounts at pharmacies near you. Free coupons can save up to 80% on prescriptions.
Disclosure: This link may earn us a commission at no extra cost to you. See our terms.
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 further shape supply and switching decisions. This page summarizes public FDA data for educational purposes only and is not a substitute for professional medical advice, always consult a licensed healthcare provider before starting, stopping, or changing any medication.
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. Always consult a healthcare professional before making medication decisions.
Last updated: December 16, 2024
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 and last refreshed May 2026. See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a correction.
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