hydroxyzine
Brand names: Vistaril, Atarax
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.
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.
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.
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.
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.
Storage
Store hydroxyzine at room temperature (68° to 77°F) and protect it from moisture.
Side Effects (from patient reports)
Based on 24,098 FDA adverse event reports.
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
Death-Related Reports
6,351
Hospitalization Reports
13,813
Top Indication
Product Used For Unknown Indication
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 1 | DRUG INEFFECTIVE | 2,973 |
| 2 | PRURITUS | 2,965 |
| 3 | NAUSEA | 2,612 |
| 4 | FATIGUE | 2,605 |
| 5 | TOXICITY TO VARIOUS AGENTS | 2,302 |
| 6 | OFF LABEL USE | 2,251 |
| 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 |
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.
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.
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budesonide nasal
Rhinocort
Rhinocort is a nasal spray that helps relieve allergy symptoms.
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cetirizine
Zyrtec
Cetirizine (Zyrtec) is an antihistamine medicine.
Compare with hydroxyzine →
chlorpheniramine
Chlor-Trimeton
Chlorpheniramine is an antihistamine medicine.
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ciclesonide nasal
Omnaris, Zetonna
Omnaris Nasal Spray is a medicine that helps treat allergy symptoms in your nose.
Compare with hydroxyzine →
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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 24,098 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.
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