Key facts
- Active ingredient
- Hydroxyzine Hydrochloride
- Drug class
- Antihistamine
- Form
- Injectable, Solution, Syrup, Tablet
- Strength
- Hydroxyzine Hydrochloride 10MG
- Type
- Prescription (Rx)
- Brand or generic
- Generic
- May treat
- anxiety disorders, nausea, pruritus
- Manufacturer
- Pliva
- Half-life
- about 14 to 20 hours in healthy adults (two reported mean values: 20.0 ± 4.1 hours and 14.0 hours) (how long it stays in your system)
- What the pharmacy pays
- ~$0.04 per ml — not your price
- FDA application
- ANDA088617
What is Hydroxyzine Hydrochloride?
From the FDA label:Hydroxyzine hydrochloride, USP has the chemical name of 2-[2-[4-( p -Chloro-α-phenylbenzyl)-1-piperazinyl]ethoxy]ethanol dihydrochloride. C 21 H 27 ClN 2 O 2 · 2HCl M.W. 447.83 Hydroxyzine hydrochloride, USP occurs as a white, odorless powder which is very soluble in water. Each tablet for oral administration contains 10 mg, 25 mg, or 50 mg hydroxyzine hydrochloride, USP. Inactive ingredients include: anhydrous lactose, carnauba wax, colloidal silicon dioxide, crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, sodium starch glycolate, titanium dioxide, and triacetin. structural formula
How to use
Hydroxyzine Hydrochloride is sold in more than one form (Injectable, Solution, Syrup and Tablet), and each is dosed differently. The instructions below come from the FDA label for application ANDA088617 — follow the label that came with the product you were actually 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.
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.
Warnings
Important safety information
Nursing Mothers It is not known whether this drug is excreted in human milk. Since many drugs are so excreted, hydroxyzine should not be given to nursing mothers.
Who should not 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.
Overdose — what happens if you take too much
The most common manifestation of hydroxyzine overdosage is hypersedation. Other reported signs and symptoms were convulsions, stupor, nausea and vomiting. As in the management of overdosage with any drug, it should be borne in mind that multiple agents may have been taken. If vomiting has not occurred spontaneously, it should be induced. Immediate gastric lavage is also recommended. General supportive care, including frequent monitoring of the vital signs and close observation of the patient, is indicated. Hypotension, though unlikely, may be controlled with intravenous fluids and levarterenol or metaraminol. Do not use epinephrine as hydroxyzine counteracts its pressor action. Hydroxyzine overdose may cause QT prolongation and Torsade de Pointes. ECG monitoring is recommended in cases of hydroxyzine overdose. There is no specific antidote. It is doubtful that hemodialysis would be of any value in the treatment of overdosage with hydroxyzine. However, if other agents such as barbiturates have been ingested concomitantly, hemodialysis may be indicated. There is no practical method to quantitate hydroxyzine in body fluids or tissue after its ingestion or administration.
U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.
How long does Hydroxyzine Hydrochloride stay in your body?
The elimination half-life of hydroxyzine hydrochloride is about 14 to 20 hours in healthy adults (two reported mean values: 20.0 ± 4.1 hours and 14.0 hours) — the time it takes the body to clear about half of it. As a rule of thumb, a medicine is mostly gone after roughly 4 to 5 half-lives, though this varies from person to person with age and kidney or liver function. 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.
This is general information, not medical advice. It doesn’t tell you when a drug test would read negative (tests detect substances for different, often longer, windows) or when it’s safe to take another dose — ask your pharmacist or prescriber. Source: Hydroxyzine Hydrochloride 25 mg Film-coated Tablets — Summary of Product Characteristics (SmPC), section 5.2 Pharmacokinetic properties.
Drug class
May treat (source: NIH RxClass)
Dosage forms
Injectable, Solution, Syrup and Tablet
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
Ask for the generic
Same active ingredient, far cheaper. Is there a generic? →
Request a 90-day supply
Bulk fills usually lower the per-dose price vs monthly refills.
Use copay cards
Manufacturer copay cards & patient-assistance programs — especially for brand drugs.
Compare alternatives
A same-class option may cost less. See alternatives →
Frequently asked questions
- What does Hydroxyzine Hydrochloride treat?
- Hydroxyzine Hydrochloride (Hydroxyzine Hydrochloride) may be used to treat anxiety disorders, nausea, pruritus, substance withdrawal syndrome, vomiting, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- How much does Hydroxyzine Hydrochloride cost?
- Nobody can tell you what you will pay — your price is set by your insurer's formulary, your deductible and the pharmacy's markup, and none of those are published. What IS published is what the pharmacy paid to acquire it: about $0.04 per ml, per the CMS NADAC survey. Treat that as the floor, not the quote — ask the pharmacist for the cash price as well as your copay, because for cheap generics the cash price often wins.
- Is there a coupon or discount for Hydroxyzine Hydrochloride?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Hydroxyzine Hydrochloride. To pay less, Hydroxyzine Hydrochloride is already a generic — usually the lowest-cost version — so the main levers are comparing cash prices between pharmacies and using a pharmacy discount-card service. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Hydroxyzine Hydrochloride?
- Hydroxyzine Hydrochloride is marketed by Pliva. You can see Pliva's full profile, rating, and other products on pharmaranks.
- Is Hydroxyzine Hydrochloride a brand-name or generic drug?
- Hydroxyzine Hydrochloride is a generic medication; its active ingredient is Hydroxyzine Hydrochloride. Generics contain the same active ingredient as the brand-name original and are usually lower cost.
- Is Hydroxyzine Hydrochloride available over the counter?
- No. Hydroxyzine Hydrochloride is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Hydroxyzine Hydrochloride come in?
- Hydroxyzine Hydrochloride is currently marketed as injectable, solution, syrup and tablet, per the FDA's National Drug Code Directory.
- What class of drug is Hydroxyzine Hydrochloride?
- Hydroxyzine Hydrochloride is classified as antihistamine, per the FDA's Established Pharmacologic Class.
- Is Hydroxyzine Hydrochloride FDA-registered?
- Hydroxyzine Hydrochloride is on record with the U.S. FDA under application number ANDA088617. You can verify this on its official FDA label.
- Is Hydroxyzine Hydrochloride safe?
- There's no single safe-or-not verdict, and we don't yet have a composite recall-safety score for Hydroxyzine Hydrochloride. Review its FDA-label side effects and warnings below, and always consult a licensed professional.
- What are the side effects of Hydroxyzine Hydrochloride?
- Hydroxyzine Hydrochloride's side effects are taken directly from its FDA label. From the label: 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.… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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