Hydroxyzine: uses, dosing, side effects & brands
Hydroxyzine is an antihistamine sold in the U.S. under 4 brand and generic names, for anxiety disorders, nausea and pruritus. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
Key facts
- Drug class
- Antihistamine
- Treats (across its forms)
- Anxiety Disorders, Nausea and Pruritus
- Available as
- Capsule · Tablet · Injectable · Solution · Syrup
- Sold as
- 4 products — Hydroxyzine Pamoate, Atarax and Vistaril, and others
- Prescription?
- Prescription only
- Generic available?
- Yes
- Half-life
- about 14 to 20 hours in healthy adults (two reported mean values: 20.0 ± 4.1 hours and 14.0 hours)
- What the pharmacy pays
- about $0.04 per ml — not your price
How Hydroxyzine Hydrochloride is dosed
From the FDA label for Hydroxyzine Hydrochloride (application ANDA088617). Other hydroxyzine products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
For symptomatic relief of anxiety and tension associated with psychoneurosis and as an adjunct in organic disease states in which anxiety is manifested: adults, 50 to 100 mg q.i.d.; children under 6 years, 50 mg daily in divided doses; children over 6 years, 50 to 100 mg daily in divided doses. For use in the management of pruritus due to allergic conditions such as chronic urticaria and atopic and contact dermatoses and in histamine-mediated pruritus: adults, 25 mg t.i.d. or q.i.d.; children under 6 years, 50 mg daily in divided doses; children over 6 years, 50 to 100 mg daily in divided doses. As a sedative when used as a premedication and following general anesthesia: 50 to 100 mg for adults and 0.6 mg/kg of body weight in children. When treatment is initiated by the intramuscular route of administration, subsequent doses may be administered orally. As with all potent medication, the dosage should be adjusted according to the patient’s response to therapy.
Everything below is the FDA label for Hydroxyzine Hydrochloride (injectable, solution, syrup, tablet). Hydroxyzine is also sold as capsule, and those are different medicines to take — follow the label for the one you were prescribed.
Hydroxyzine Hydrochloride side effects
Side effects reported with the administration of hydroxyzine hydrochloride are usually mild and transitory in nature. Anticholinergic: Dry mouth. Central Nervous System: Drowsiness is usually transitory and may disappear in a few days of continued therapy or upon reduction of dose. Involuntary motor activity including rare instances of tremor and convulsions have been reported, usually with doses considerably higher than those recommended. Clinically significant respiratory depression has not been reported at recommended doses. Cardiac System: QT prolongation, Torsade de Pointes. In postmarketing experience, the following additional undesirable effects have been reported: Body as a Whole: Allergic reaction. Nervous System: Headache. Psychiatric: Hallucination. Skin and Appendages: Oral hydroxyzine is associated with Acute Generalized Exanthematous Pustulosis (AGEP) and fixed drug eruptions in postmarketing reports; pruritus, rash, urticaria.
Who shouldn’t take Hydroxyzine Hydrochloride
Oral hydroxyzine hydrochloride is contraindicated in patients with known hypersensitivity to hydroxyzine hydrochloride products, and in patients with known hypersensitivity to cetirizine hydrochloride or levocetirizine hydrochloride. Hydroxyzine is contraindicated in patients with a prolonged QT interval. Hydroxyzine, when administered to the pregnant mouse, rat, and rabbit induced fetal abnormalities in the rat and mouse at doses substantially above the human therapeutic range. Clinical data in human beings are inadequate to establish safety in early pregnancy. Until such data are available, hydroxyzine is contraindicated in early pregnancy. Hydroxyzine is contraindicated for patients who have shown a previous hypersensitivity to any component of this medication.
Every hydroxyzine product we track (4)
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
| # | Drug | Rating | Type | Form | Generic? | Pharmacy pays | |
|---|---|---|---|---|---|---|---|
| 1 | 70/100 | Prescription | Capsule | No data | — | View → | |
| 2 | 64/100 | Prescription | Tablet | Generic | $0 | View → | |
| 3 | 64/100 | Prescription | Capsule | Generic | $0 | View → | |
| 4 | Not yet rated | Prescription | Injectable | Generic | $0 | View → |
What hydroxyzine pills look like
Imprint codes, colour and shape from the FDA’s labelling data. Match the imprint on your pill — or search any imprint.
Hydroxyzine recalls
From the FDA Enforcement database. A recall covers specific lots — not the drug as a whole.
How long hydroxyzine keeps
No hydroxyzine label we read sets a separate limit for after opening, but they do specify how it must be stored — and the stability behind any date assumes those conditions.
Does hydroxyzine expire? The in-use limits and storage rules from its labelsHydroxyzine and breastfeeding
From LactMed, the US National Library of Medicine’s Drugs and Lactation Database — quoted, not rewritten.
Full LactMed record for hydroxyzine: levels in milk, effects in breastfed infants, and the drugs it would consider insteadSmall occasional doses of hydroxyzine would not be expected to cause any adverse effects in breastfed infants. Larger doses or more prolonged use may cause drowsiness and other effects in the infant or decrease the milk supply, particularly in combination with a sympathomimetic such as pseudoephedrine or before lactation is well established. Other agents are preferred, especially while nursing a newborn or preterm infant.
National Institute of Child Health and Human Development, record revised September 15, 2025. LactMed states its information is not a substitute for professional judgement.
What people report to the FDA about hydroxyzine
The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 13,821 reports naming hydroxyzine, and the FDA flagged 56% of those reports as serious. The effects reported most often — leaving out reports about overdose, misuse or the condition being treated, which dominate the raw list for common medicines:
- pruritus1,125 reports
- nausea869 reports
- fatigue863 reports
- rash831 reports
- headache816 reports
- diarrhoea635 reports
- dyspnoea603 reports
- vomiting562 reports
Read these as a signal, not a rate. A report does not mean hydroxyzine caused the effect — anyone can file one, and many describe people taking several medicines for several conditions. Crucially there is no denominator: FAERS does not record how many people took the drug, so these counts cannot be turned into “X% of patients” — a bigger number often just means a more widely used or more talked-about drug. Duplicates exist, and publicity drives reporting. For what is actually established, read the FDA label section above.
Source: openFDA drug/event (FAERS), retrieved August 25, 2026.
How long hydroxyzine stays in your system
The elimination half-life of hydroxyzine is about 14 to 20 hours in healthy adults (two reported mean values: 20.0 ± 4.1 hours and 14.0 hours). This is the parent drug's elimination half-life. It varies a lot by age — averaging about 29 hours in older adults and about 7 hours in children. Hydroxyzine is broken down into an active metabolite, cetirizine (itself an antihistamine), which is cleared by the kidneys and can build up when kidney function is impaired.
Hydroxyzine Hydrochloride 25 mg Film-coated Tablets — Summary of Product Characteristics (SmPC), section 5.2 Pharmacokinetic properties ↗Half-life is how long the body takes to clear half a dose. It is not the same as how long a drug test can detect it, and it varies with age, kidney and liver function.
Can you drink alcohol on hydroxyzine?
The label says use caution
The label addresses alcohol in its Precautions. It cautions that the effect of alcohol may be increased by hydroxyzine, because hydroxyzine potentiates the action of central nervous system depressants (it names narcotics, non-narcotic analgesics, and barbiturates). Patients are advised against the simultaneous use of other CNS depressant drugs. This is an additive CNS-depression/sedation caution, not a disulfiram-like flushing reaction.
Is hydroxyzine safe during pregnancy?
The label says do not use in pregnancy
The label states hydroxyzine is contraindicated in early pregnancy. It notes that in animal studies (mouse, rat, rabbit) hydroxyzine induced fetal abnormalities in the rat and mouse at doses substantially above the human therapeutic range, and that human data are inadequate to establish safety in early pregnancy — so until such data exist, it is contraindicated early in pregnancy. Anyone who is or may become pregnant should discuss this with their prescriber.
This is what hydroxyzine’s FDA label says — not a recommendation to take or stop it. In pregnancy, that decision is your prescriber’s; do not start or stop a medicine on your own.
Hydroxyzine Pamoate — DailyMed FDA label ↗Related guides
Related calculators
Frequently asked questions
What is Hydroxyzine Hydrochloride?
Hydroxyzine Hydrochloride is an antihistamine used to treat Anxiety Disorders, Nausea, Pruritus, Substance Withdrawal Syndrome.
What kind of drug is hydroxyzine?
The FDA classifies hydroxyzine as an antihistamine. If you are checking whether it is safe to combine with something else, the class is what matters — two drugs from the same class usually should not be stacked.
Is hydroxyzine safe during pregnancy?
The label states hydroxyzine is contraindicated in early pregnancy. It notes that in animal studies (mouse, rat, rabbit) hydroxyzine induced fetal abnormalities in the rat and mouse at doses substantially above the human therapeutic range, and that human data are inadequate to establish safety in early pregnancy — so until such data exist, it is contraindicated early in pregnancy. Anyone who is or may become pregnant should discuss this with their prescriber. This is what hydroxyzine's FDA label says; whether to use it in pregnancy is your prescriber's decision.
Can you drink alcohol while taking hydroxyzine?
The label addresses alcohol in its Precautions. It cautions that the effect of alcohol may be increased by hydroxyzine, because hydroxyzine potentiates the action of central nervous system depressants (it names narcotics, non-narcotic analgesics, and barbiturates). Patients are advised against the simultaneous use of other CNS depressant drugs. This is an additive CNS-depression/sedation caution, not a disulfiram-like flushing reaction. This is what hydroxyzine's FDA label says; alcohol advice depends on your dose and health, so confirm with your pharmacist.
How long does hydroxyzine stay in your system?
The elimination half-life of hydroxyzine is about 14 to 20 hours in healthy adults (two reported mean values: 20.0 ± 4.1 hours and 14.0 hours) — that is how long the body takes to clear half of a dose. This is the parent drug's elimination half-life. It varies a lot by age — averaging about 29 hours in older adults and about 7 hours in children. Hydroxyzine is broken down into an active metabolite, cetirizine (itself an antihistamine), which is cleared by the kidneys and can build up when kidney function is impaired. Half-life is not the same as how long a drug test can detect the drug, and it varies with age, kidney and liver function.
Can you take hydroxyzine with other medicines?
It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run hydroxyzine against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
What brand names is hydroxyzine sold under?
We track 4 hydroxyzine-containing products in the U.S.: Hydroxyzine Pamoate, Atarax, Vistaril and Hydroxyzine Hydrochloride. They are the same active ingredient; they differ in form, manufacturer, price and FDA recall record.
What forms does hydroxyzine come in?
Across the brands we track, hydroxyzine is currently marketed as capsule, tablet, injectable, solution and syrup, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.
Is there a generic hydroxyzine?
Yes. Our catalog lists 2 generic hydroxyzine products alongside the brand versions. A generic has the same active ingredient and must meet the FDA's bioequivalence standard; it usually costs less. Ask your pharmacist which one your plan covers.
Has hydroxyzine been recalled?
The FDA's Enforcement database lists 1 recall record whose product description mentions hydroxyzine. The most recent: hydrOXYzine Hydrochloride Oral Solution (Jun 2, 2026). A recall applies to specific lots, not to the drug as a whole — check the record for the affected lot numbers.
How long does it take for hydroxyzine to work?
Hydroxyzine works fast. For itching, anxiety, or its calming, sleepy effect, most people feel it within about 15-60 minutes, with peak effect around two hours and relief lasting several hours. It's meant for on-demand or short-term use, not a slow-building daily medicine. Because it can make you drowsy, don't drive until you know how it affects you.
What should I avoid while taking hydroxyzine?
Alcohol: the FDA label flags alcohol as something to be careful with — see the alcohol section above for what it actually says. This is what the FDA label and our cited sources say — it is not a complete list. Your pharmacist can check your own combination.
Is hydroxyzine a controlled substance?
No. Hydroxyzine (Vistaril, Atarax) is an antihistamine used for anxiety, itching and nausea; it is NOT a DEA-scheduled controlled substance and is not habit-forming, which is part of why it is chosen as a non-addictive as-needed option. It is sedating, so it can cause drowsiness.
What are the common side effects of Vistaril/Atarax (hydroxyzine)?
The most common and expected effect of hydroxyzine (sold as Vistaril and Atarax) is drowsiness or sedation, which can be marked. MedlinePlus and the FDA label also list dry mouth, dizziness, and headache, and hydroxyzine's antihistamine action can cause blurred vision. These effects are often strongest when you start or increase the dose. Alcohol and other sedating medicines can make the drowsiness worse.
What serious side effects of Vistaril/Atarax (hydroxyzine) mean I should call a doctor or go to the ER?
The most important serious risk is a heart-rhythm problem. The FDA label states that "Cases of QT prolongation and Torsade de Pointes have been reported" and that "Hydroxyzine is contraindicated in patients with a prolonged QT interval." Get emergency care for fainting, or a fast, pounding, or irregular heartbeat. Tell your doctor before starting if you have a long-QT history or take other QT-prolonging drugs — the label says "Caution is recommended during the concomitant use of drugs known to prolong the QT interval." Also call your doctor right away for a rash or blister-like sores, swelling, fever, seizures, or unusual trembling/shaking, which MedlinePlus lists as reasons to "call your doctor immediately."
Is Vistaril/Atarax (hydroxyzine) safe for older adults, and can it affect driving?
Both cautions come straight from the FDA label. On driving: "Since drowsiness may occur with use of this drug, patients should be warned of this possibility and cautioned against driving a car or operating dangerous machinery" until you know how it affects you. On older adults, the label warns that "Sedating drugs may cause confusion and over sedation in the elderly; elderly patients generally should be started on low doses of hydroxyzine and observed closely." Its anticholinergic burden (confusion, falls) is why hydroxyzine appears on the American Geriatrics Society Beers list of medicines to use with caution in adults 65 and older.
Can I take Vistaril/Atarax (hydroxyzine) long term for anxiety?
The FDA label is explicit that this hasn't been proven: "The effectiveness of hydroxyzine as an antianxiety agent for long term use, that is more than 4 months, has not been assessed by systematic clinical studies." Hydroxyzine is generally used short-term or as-needed for anxiety, itching, and sedation rather than as an ongoing daily anxiety treatment. If you've been taking it for months, talk with your prescriber about whether it's still the right option rather than deciding on your own.
When do Vistaril/Atarax (hydroxyzine) side effects start, and can I just stop?
Drowsiness typically appears soon after a dose, which is why the FDA warns against driving until you know your response; MedlinePlus notes hydroxyzine is usually taken three or four times a day. Unlike some prescription drugs, hydroxyzine is not known for a dangerous withdrawal reaction, but you should still not stop a prescribed medicine on your own — check with your doctor or pharmacist first, especially if you're taking it for a diagnosed condition. This is not a complete list of side effects; report anything unusual to your clinician.
What is Vistaril/Atarax (hydroxyzine) used for?
Hydroxyzine (brand names Vistaril and Atarax) is an antihistamine with three FDA-approved uses: to relieve anxiety and tension, to relieve itching caused by allergic skin conditions like chronic hives (urticaria) and dermatitis, and as a sedative before and after general anesthesia for surgery (MedlinePlus). Off-label — legal and common, but not FDA-approved for this drug — clinicians also prescribe it as a short-term sleep aid for insomnia and to control nausea and vomiting, uses that draw on its antihistamine and antiemetic properties. Because it is fast-acting and non-addictive, it is often chosen when a doctor wants to avoid habit-forming options. This is not a complete list; ask your prescriber which use applies to you, and never start or stop a prescription on your own.
Is hydroxyzine good for anxiety?
Yes — anxiety and tension are among hydroxyzine's FDA-approved uses (MedlinePlus), so this is an on-label indication, not off-label. It is an antihistamine rather than a benzodiazepine, which makes it a fast-acting and non-addictive option that is often used short-term or as-needed for anxiety. The main trade-off is that it is sedating and can cause drowsiness, so it is typically prescribed for short-term relief; its labeling notes that effectiveness as an anti-anxiety agent for long-term use (more than about four months) has not been well established, so it is generally used short-term. Whether it is the right fit depends on your situation — discuss it with your prescriber rather than adjusting a prescription yourself.
Cite this page
- APA
- pharmaranks. (2026, July 24). Hydroxyzine: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/hydroxyzine
- MLA
- “Hydroxyzine: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/hydroxyzine.
We summarise public FDA and NIH sources — for a clinical claim, cite the primary source we link to as well.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Read the full FDA label for hydroxyzine on DailyMed (NIH) ↗.