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hydroxyzine

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Brand names: Vistaril, Atarax

Antihistamine / Anxiolytic Rx

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.

The medicine did not work
2,973
Itching
2,967
Feeling sick to your stomach
2,614
Feeling tired
2,607
Harm from other substances
2,302
Using the medicine for something it's not approved for
2,251
Pain
2,188
Headache
2,141
Suicide
2,064
Skin rash
1,991

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

Female 26,625 (66%)
Male 13,607 (34%)

Age Distribution

0–17 2,522
18–44 8,921
45–64 11,383
65–74 4,641
75+ 2,855

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

COMPLETED SUICIDE 2,057
TOXICITY TO VARIOUS AGENTS 1,629
DEATH 1,208
DRUG ABUSE 650
CARDIO-RESPIRATORY ARREST 552
CARDIAC ARREST 435
RESPIRATORY ARREST 266
POISONING 212
OVERDOSE 210
SUSPECTED SUICIDE 195

Reactions in Hospitalization Reports

NAUSEA 974
DYSPNOEA 915
TOXICITY TO VARIOUS AGENTS 899
VOMITING 802
FALL 777
FATIGUE 773
PAIN 765
PNEUMONIA 749
HYPOTENSION 688
ANXIETY 682

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?
Hydroxyzine can cause drowsiness, so be careful when driving or operating machinery until you know how it affects you.
Can I drink alcohol while taking hydroxyzine?
Drinking alcohol while taking hydroxyzine can increase drowsiness. It is best to avoid alcohol.
How long does it take for hydroxyzine to work?
Hydroxyzine usually starts working within 15 to 30 minutes.
Can I take hydroxyzine long-term?
Your doctor should check if you still need to take hydroxyzine if you have been taking it for more than 4 months.
What should I do if I overdose?
Seek medical attention immediately if you think you have taken too much hydroxyzine.
Can children take hydroxyzine?
Yes, children can take hydroxyzine, but the dose is different than for adults. Follow your doctor's instructions carefully.
Does hydroxyzine interact with other medications?
Yes, hydroxyzine can interact with other medications. Tell your doctor about all the medicines you take.
Can hydroxyzine cause weight gain?
Weight gain is not a common side effect of hydroxyzine.
Is hydroxyzine addictive?
Hydroxyzine is not considered to be addictive.
What are the inactive ingredients in hydroxyzine capsules?
Inactive ingredients include colloidal silicon dioxide, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, sodium starch glycolate (potato), and sodium lauryl sulfate. The capsule shell contains D&C Yellow #10, FD&C Green #3, FD&C Yellow #6, gelatin, and titanium dioxide.
What are the common side effects of hydroxyzine?
The most commonly reported side effects of hydroxyzine include Dry mouth, Drowsiness. Based on 24,098 FDA adverse event reports. Always consult your healthcare provider about potential side effects.
Does hydroxyzine interact with other medications?
Yes, hydroxyzine has 1 known drug interactions. Notable interactions include midazolam. Always inform your doctor about all medications you are taking.
What drug class is hydroxyzine?
hydroxyzine belongs to the Antihistamine / Anxiolytic drug class. It requires a prescription (Rx). Hydroxyzine is used to relieve anxiety and tension, especially when related to mental health conditions or other illnesses.
Is hydroxyzine safe during pregnancy?
Do not take hydroxyzine if you are pregnant, especially in early pregnancy. It may cause harm to your unborn baby. Always consult your healthcare provider before using any medication during pregnancy or breastfeeding.

Related Medications in Antihistamine / Anxiolytic

Other drugs grouped near hydroxyzine — same-class peers and common alternatives.

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Medication Guides

Related Health & Safety Data

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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

All federal data sources used on this page