Medication approval journey

hydroxyzine (Vistaril)

Approved for Anxiety and tension associated with psychoneurosis

page first published · last updated

Also answers to “the antique armchair” — its codename in our videos and posts. The full codebook

FDA approvedOther anti-anxiety medicationTaper risk: low

How this page reads

The page as written, with the clinical terms

Plain language uses the same facts, the same numbers and the same caveats. It does not leave anything out. Quotes from the FDA label are never reworded in either setting.

Before you stop or change your hydroxyzine dose

Low risk from stopping, but still worth planning

Withdrawal risk in this group is generally low, but dose changes are still worth discussing rather than improvising.

what the hydroxyzine warnings mean

label facts below are read from the hydroxyzine hydrochloride tablets FDA label on DailyMed, set id 8f41912e-12ce-4174-a0fb-cfb4888d8d58, version 7, effective august 27, 2026 (remedyrepack, anda 217652), the set the dossier above cites. it is an old-format label without numbered sections, so the brackets name the section instead. every source is linked at the end of this section. last checked 2026-10-12.

hydroxyzine was approved on may 31, 1956, for "symptomatic relief of anxiety and tension associated with psychoneurosis", for itching from allergic conditions, and as a sedative before and after anaesthesia [label, indications; approval]. about 4.7 million americans filled a prescription for it in 2024, up from about 2.4 million in 2014, and the number of prescriptions nearly doubled, from 7.8 million to 14.9 million, a rise larger than the survey’s margin of error [meps]. it is an antihistamine, which the label says is "unrelated chemically to the phenothiazines, reserpine, meprobamate or the benzodiazepines" [label, clinical pharmacology], and its label carries no boxed warning. what it carries instead is a heart-rhythm warning on qt prolongation and torsade de pointes, a contraindication in anyone whose qt interval is already long, a contraindication in early pregnancy, a serious skin reaction, and one sentence about its own evidence that is worth reading twice: "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" [label, indications]. this section says what each of those means in plain words, what the label does and does not say about trials, which side effects it lists and whether it counts them, and what independent research has found, in both directions. every number is from the label or from a study linked at the end.

this is information to take to a prescriber. nothing here is a reason to start, stop or change a dose on your own. the label has no discontinuation section and gives no taper, so any question about stopping is one for the prescriber, not this page.

no boxed warning, and the heart-rhythm warning in the label’s words

the hydroxyzine label has no boxed warning. the qt language sits in four ordinary sections, and the first is the precautions paragraph, quoted whole: "qt prolongation/torsade de pointes (tdp): cases of qt prolongation and torsade de pointes have been reported during post-marketing use of hydroxyzine. the majority of reports occurred in patients with other risk factors for qt prolongation/tdp (pre-existing heart disease, electrolyte imbalances or concomitant arrhythmogenic drug use). therefore, hydroxyzine should be used with caution in patients with risk factors for qt prolongation, congenital long qt syndrome, a family history of long qt syndrome, other conditions that predispose to qt prolongation and ventricular arrhythmia, as well as recent myocardial infarction, uncompensated heart failure, and bradyarrhythmias" [label, precautions]. the paragraph then names the drugs it means: class 1a antiarrhythmics (quinidine, procainamide) and class iii (amiodarone, sotalol), the antipsychotics ziprasidone, iloperidone, clozapine, quetiapine and chlorpromazine, the antidepressants citalopram and fluoxetine, the antibiotics azithromycin, erythromycin, clarithromycin, gatifloxacin and moxifloxacin, and pentamidine, methadone, ondansetron and droperidol [label, precautions].

the second place is the contraindications section, one sentence that goes further than caution: "hydroxyzine is contraindicated in patients with a prolonged qt interval" [label, contraindications]. the third is the adverse reactions list, under cardiac system: "qt prolongation, torsade de pointes" [label, adverse reactions]. the fourth is overdose: "hydroxyzine overdose may cause qt prolongation and torsade de pointes. ecg monitoring is recommended in cases of hydroxyzine overdose" [label, overdosage].

three things the words mean. "post-marketing reports" are case reports filed after approval, without a denominator: they can establish that something has happened and cannot establish how often, and the label gives no rate, no count and no qt measurement in milliseconds. "the majority occurred in patients with other risk factors" cuts both ways: a healthy adult with no heart disease, normal electrolytes and no interacting drugs is not the population the reports describe, and the risk factors it lists are common enough that the qualifier covers a great many real patients. and a contraindication is not a caution: for someone whose qt interval is already long, the label does not say use carefully, it says do not. the european regulator’s reading of the same signal, and the dose cap it produced, are in the next block. this site’s earlier article on this one warning, which is where this explainer program began, is linked at the end [qt-blog].

the dose: what the us label permits and what europe capped

the us label’s anxiety dose is "50 to 100 mg q.i.d.", four times a day, for adults, with 50 mg a day in divided doses for children under 6 and 50 to 100 mg a day for children over 6 [label, dosage and administration]. the label sets no maximum of its own beyond that range and sets no lower dose for older people, though it says dose selection for an elderly patient "should be cautious, usually starting at the low end of the dosing range" [label, precautions, geriatric use].

in february 2015 the european medicines agency’s safety committee concluded that hydroxyzine carries "a small but definite risk" of qt prolongation and torsade de pointes, capped the adult dose at 100 mg a day and the dose in the elderly at 50 mg, and advised against use in people with heart-rhythm risk factors or on other qt-prolonging drugs [prac-2015]. the top of the us label’s adult range, 100 mg four times a day, is four times the european ceiling. the same evidence produced two regulatory answers, a warning paragraph and a contraindication in the united states and a dose cap in europe; this page records the divergence and does not rule on it. the question it hands a patient is a plain one: if the prescription is above 100 mg a day, what makes the higher dose right for me?

what the label says about its own trials: nothing

the label has no clinical studies section. no trial count, no duration, no participant number and no comparator appears anywhere on it, and its adverse-reaction list carries no incidence figures [label, adverse reactions]. its one statement about systematic evidence is negative: "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. the physician should reassess periodically the usefulness of the drug for the individual patient" [label, indications]. the approval record gives the date, may 31, 1956, and the application number [approval]; the dossier above explains why a drug approved in that year carries no efficacy trials on its label. the label does say when it starts working: clinical effects "are usually noted within 15 to 30 minutes after oral administration" [label, clinical pharmacology]. for the trials that do exist, run by researchers decades after approval, see the research section below.

the other precautions and contraindications, in plain words

this is an old-format label, so there is no numbered warnings list; the items below are everything else the contraindications, warnings and precautions sections carry.

  • early pregnancy, contraindicated: hydroxyzine "induced fetal abnormalities in the rat and mouse at doses substantially above the human therapeutic range", human data "are inadequate to establish safety in early pregnancy", and "until such data are available, hydroxyzine is contraindicated in early pregnancy" [contraindications]. this is an animal finding plus an absence of human data, and the label treats the absence as a reason not to use it.
  • breastfeeding: "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" [warnings]. that is the entire warnings section of this label.
  • other sedatives, in the label’s capitals: "the potentiating action of hydroxyzine must be considered when the drug is used in conjunction with central nervous system depressants such as narcotics, non-narcotic analgesics and barbiturates", whose doses "should be reduced" when given alongside it [precautions].
  • driving and alcohol: because drowsiness may occur, patients should be "cautioned against driving a car or operating dangerous machinery", advised against other cns depressants, and told that "the effects of alcohol may be increased" [precautions].
  • older people: "sedating drugs may cause confusion and over sedation in the elderly"; the label says to start low and observe closely, notes that the extent of kidney excretion "has not been determined", and says it has not been established whether the controlled studies included enough people over 65 to tell [precautions, geriatric use].
  • a serious skin reaction: hydroxyzine "may rarely cause acute generalized exanthematous pustulosis (agep)", fever with many small sterile pustules over large red swollen areas. the label says to stop at the first sign of a rash or any sign of hypersensitivity, not to restart if agep is suspected, and to avoid cetirizine and levocetirizine afterwards because of cross-sensitivity [precautions]. this and serotonin-type emergencies are the only places a label tells a patient to stop; it is an instruction about an emergency, not a routine decision.
  • cetirizine and levocetirizine: hydroxyzine is contraindicated in anyone with a known hypersensitivity to either, because they are related compounds [contraindications].
  • overdose: the most common sign is "hypersedation"; others are convulsions, stupor, nausea and vomiting. low blood pressure is "unlikely", and the label says not to use epinephrine because hydroxyzine counteracts it. there is no specific antidote, dialysis is "doubtful" to help, and ecg monitoring is recommended for the qt risk [overdosage].

side effects, and why there are no numbers

the label characterises its side effects as "usually mild and transitory in nature" and lists them without frequencies, because it reports no controlled trial from which a frequency could come [label, adverse reactions]. the list: dry mouth; drowsiness, which "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", usually at doses considerably higher than recommended; and, under cardiac system, qt prolongation and torsade de pointes. the label states that "clinically significant respiratory depression has not been reported at recommended doses". post-marketing reports add allergic reaction, headache, hallucination, agep, fixed drug eruptions, itching, rash and hives [label, adverse reactions]. a reader used to the drug-versus-placebo tables on other labels on this site should notice their absence here: it is not that hydroxyzine has fewer side effects, it is that the label never counted them. the trials in the next section are the only counted record.

what the research says, in both directions

in favour. the cochrane review of hydroxyzine for generalised anxiety disorder pooled five randomised trials with 884 participants and found it reduced anxiety symptoms more than placebo and was reasonably tolerated [guaiana-2010]. in a 12-week trial of 334 adults with generalised anxiety, 50 mg a day lowered hamilton anxiety scores by about 12 points against 10 on placebo, and worked about as well as the benzodiazepine bromazepam [llorca-2002]. in a 4-week trial of 244 adults, 50 mg a day cut hamilton scores by about 10.8 points against 7.2 on placebo, and hydroxyzine was the only drug in the trial to clearly beat placebo on the main measure; buspirone’s advantage appeared only on secondary ones [lader-1998]. both trials ran at 50 mg a day, half the european cap and an eighth of the top of the us label’s range.

against, or smaller than it sounds. the same cochrane review found the evidence too thin to compare hydroxyzine with benzodiazepines or buspirone, and its reviewers concluded it should not be a first-line treatment ahead of antidepressants [guaiana-2010]. the two trials above are from before trial registration, and the funding source of each could not be read from the available records [llorca-2002; lader-1998]. the 12-week edge over placebo is about 2 points on a scale where both groups fell 10 or more [llorca-2002]. twelve weeks is the longest trial on this page, and the label says effectiveness beyond four months has never been systematically assessed, so for anyone who has taken it longer than that the evidence is silent [label, indications]. on the heart, the european regulator judged the risk "small but definite" and acted; the us label records reports without a rate [prac-2015; label, precautions]. this site’s evidence page on the anxiety question has the trials in more detail [anxiety-topic].

questions to ask your prescriber about hydroxyzine

each one comes from a warning or a study above. they are questions, not instructions; the answers depend on a history nobody here has.

  • the label says hydroxyzine is contraindicated if my qt interval is already long, and to use it with caution if i have heart disease, low potassium or magnesium, a slow heart rate, a recent heart attack, heart failure, or long qt in the family. do any of those apply to me, and should anything be checked first?
  • i take citalopram, fluoxetine, quetiapine, ziprasidone, clozapine, methadone, ondansetron, azithromycin, clarithromycin, amiodarone or sotalol. the label names each of these as a qt-prolonging drug to be cautious with. is anything i take on that list?
  • europe caps hydroxyzine at 100 mg a day, 50 mg over 65, and the us label allows 50 to 100 mg four times a day. what is my dose, and if it is above 100 mg, what makes the higher dose right for me?
  • the label says effectiveness beyond four months has never been systematically studied and that the prescriber should reassess periodically. how long have i been on it, and when do we reassess?
  • i take an opioid, another painkiller, a sleeping pill or a barbiturate. the label says in capitals that their doses should be reduced alongside hydroxyzine. has that been considered?
  • i am pregnant or might become pregnant. the label contraindicates hydroxyzine in early pregnancy. what is the plan?
  • if i am over 65: the label says sedating drugs can cause confusion and over-sedation in older people and to start low. what dose am i on, and who is watching for confusion?
  • the label has no discontinuation section. if we ever stop, is there anything to expect, and how would we do it?

questions people ask

does hydroxyzine (vistaril, atarax) have a black box warning?
no. the hydroxyzine hydrochloride label carries no boxed warning. its heart-rhythm language sits in four ordinary sections instead: a precautions paragraph saying cases of qt prolongation and torsade de pointes have been reported after approval, mostly in people with other risk factors; a contraindication in anyone with an already prolonged qt interval; a line in the adverse-reactions list; and an overdose section recommending ecg monitoring. that placement is less prominent than a box and is not the same as no warning. the label also contraindicates hydroxyzine in early pregnancy and warns of a rare serious skin reaction.
what does the hydroxyzine label say about qt prolongation and torsade de pointes?
in its own words: "cases of qt prolongation and torsade de pointes have been reported during post-marketing use of hydroxyzine. the majority of reports occurred in patients with other risk factors for qt prolongation/tdp (pre-existing heart disease, electrolyte imbalances or concomitant arrhythmogenic drug use)." it says to use hydroxyzine with caution in people with those risk factors, congenital or familial long qt, a recent heart attack, uncompensated heart failure or slow heart rhythms, and alongside other qt-prolonging drugs, naming quinidine, procainamide, amiodarone, sotalol, ziprasidone, iloperidone, clozapine, quetiapine, chlorpromazine, citalopram, fluoxetine, azithromycin, erythromycin, clarithromycin, gatifloxacin, moxifloxacin, pentamidine, methadone, ondansetron and droperidol. separately, it says hydroxyzine "is contraindicated in patients with a prolonged qt interval". post-marketing reports have no denominator, so the label gives no rate.
is hydroxyzine safe if you have a heart condition?
the label answers in two registers. for anyone whose qt interval is already prolonged it is a contraindication, not a caution: the label says do not use it. for people with heart disease, a rhythm disorder, low potassium or magnesium, a recent heart attack, heart failure, a slow heart rate or a family history of long qt, it says to use it with caution and to be careful about other qt-prolonging drugs. in 2015 the european regulator went further and capped the dose at 100 mg a day, 50 mg in the elderly, and advised against use in people with those risk factors at all. whether a particular heart history falls on one side or the other is a prescriber’s call, and a baseline ecg or electrolyte check is a reasonable thing to ask about.
why did europe cap the hydroxyzine dose and the us did not?
in february 2015 the european medicines agency’s safety committee reviewed the cardiac signal, concluded hydroxyzine carried "a small but definite risk" of qt prolongation and torsade de pointes, and capped the adult dose at 100 mg a day and the dose in the elderly at 50 mg, advising the lowest effective dose for the shortest time and avoidance in people with rhythm risk factors or interacting drugs. the us label responded to the same signal with a precautions paragraph and a contraindication in anyone with a prolonged qt interval, but no dose cap; it still permits 50 to 100 mg four times a day for anxiety. same evidence, two regulatory answers. this page records the divergence and does not rule on which regulator was right.
does hydroxyzine work for anxiety?
in the short term, by the trials that exist, yes, modestly. the cochrane review pooled five randomised trials in 884 people and found hydroxyzine reduced generalised anxiety more than placebo and was reasonably tolerated, but the evidence was too thin to compare it with benzodiazepines or buspirone, and the reviewers said it should not be first-line ahead of antidepressants. a 12-week trial of 334 adults found 50 mg a day lowered hamilton anxiety scores by about 12 points against 10 on placebo, about as well as the benzodiazepine bromazepam; a 4-week trial of 244 adults found 10.8 points against 7.2. both trials predate trial registration and their funding could not be read. the label itself contains no trial at all and says effectiveness beyond four months has never been systematically assessed.
what are the most common hydroxyzine side effects?
the label lists them without numbers, because it reports no controlled trial to count them from. it calls them "usually mild and transitory": dry mouth; drowsiness, which it says usually fades within a few days or with a lower dose; involuntary movements including rare tremor and convulsions, usually at doses well above those recommended; and qt prolongation and torsade de pointes. post-marketing reports add allergic reactions, headache, hallucination, a rare serious pustular skin reaction (agep), fixed drug eruptions, itching, rash and hives. the label says to warn patients about driving and that alcohol’s effects may be increased, and that older people are prone to confusion and over-sedation. the absence of drug-versus-placebo rates is a fact about the label, not evidence that the drug is gentler than those that have them.
how long can you take hydroxyzine for anxiety?
the label does not set a limit, but it says in its indications section that "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", and that the prescriber "should reassess periodically the usefulness of the drug for the individual patient". the longest trial in the library ran 12 weeks. the label has no discontinuation section, no withdrawal warning and no taper; whether that silence means stopping is uneventful is not something the label says, and this page does not either. anyone past four months has a reassessment the label itself asks for.

sources for this section

the library rows link to our one-page summary of each study, with the original paper, its funding and our evidence grade on that page.

  1. hydroxyzine hydrochloride tablets prescribing information, fda label on dailymed (set id 8f41912e-12ce-4174-a0fb-cfb4888d8d58, version 7, effective august 27, 2026; remedyrepack, anda 217652): clinical pharmacology, indications and usage, contraindications, warnings, precautions (including geriatric use and agep), adverse reactions, overdosage, dosage and administration
  2. drugs@fda, nda 010485 (hydroxyzine hydrochloride), approved may 31, 1956
  3. ahrq medical expenditure panel survey, prescribed medicines public-use files 2014 (hc-168a) and 2024 (hc-254a): people with at least one hydroxyzine purchase and prescriptions, weighted; the 2014 to 2024 prescription change clears the survey’s margin of error; computed by veisund, method on the usage section of this page
  4. european medicines agency, pharmacovigilance risk assessment committee. prac recommends new measures to minimise known heart risks of hydroxyzine-containing medicines. 13 february 2015 (library row)
  5. guaiana g, barbui c, cipriani a. hydroxyzine for generalised anxiety disorder. cochrane database of systematic reviews 2010 (five trials, 884 participants) (library row)
  6. llorca pm, et al. efficacy and safety of hydroxyzine in the treatment of generalized anxiety disorder: a 3-month double-blind study. journal of clinical psychiatry 2002 (334 adults) (library row)
  7. lader m, scotto jc. a multicentre double-blind comparison of hydroxyzine, buspirone and placebo in patients with generalized anxiety disorder. psychopharmacology 1998 (244 adults, four weeks) (library row)
  8. fda hydroxyzine qt prolongation warning: what the label says, the earlier article on this site that this explainer program grew from
  9. does hydroxyzine work for anxiety? the trials, the cochrane review and the heart-rhythm warning, a separate evidence page on this site
we went and looked

claims about hydroxyzine we went and checked

  • misattributedare toddlers on medicaid being put on anti-anxiety drugs in large numberssaid on a Substack newsletter, 2026-03-10; The underlying worry is real and the public record backs it: in the 2025 reporting year the median state documented first-line psychosocial care for only 59.2 percent of children aged 1 to 11 starting an antipsychotic, got both required metabolic blood tests for 29.1 percent of young children on two or more antipsychotic prescriptions, and saw 47.6 percent of children newly prescribed an ADHD medicine again within 30 days. Those are the states' own numbers.

every check quotes one sentence, links the original at the timestamp, and takes each assertion to the primary record. the full list: /checked.

How long the hydroxyzine trials actually ran

We could not establish a longest trial length for hydroxyzine. That is a gap in what we can show you — not evidence that the trials ran long.

Approved before the Physician Labeling Rule, so no clinical studies section was ever required. The absence is the state of the public record, not a gap in our research.

The gap between how long the trials ran and how long people actually take these medications is the single most important thing on this page. It is not evidence that longer use is unsafe or ineffective. It is evidence that longer use was not what got tested.

People often stay on these drugs for far longer than the trials ran. The label does not say how long any trial ran, because it reports no trials.

That does not mean longer use is unsafe. It does not mean the drug stops working either. It means longer use was never the thing that got tested.

If you have been on it a long time, that is a fair thing to ask your prescriber about.

No boxed warning on the hydroxyzine label

The FDA label we quote for hydroxyzine carries no boxed warning. A boxed warning is the strongest warning the FDA can put on a label, and this label does not have one. That is a fact about the label. It is not a rating of how safe the drug is, and it does not mean the label warns about nothing: what it does warn about is in the sections below.

FDA label effective August 27, 2026. Read the full label on DailyMed

What hydroxyzine is FDA approved for, and what the record shows

Approved for symptomatic relief of anxiety and tension associated with psychoneurosis, and as an adjunct in organic disease states in which anxiety is manifested; the label also covers pruritus from allergic conditions and pre- and post-anesthetic sedation in 1956, under application NDA 010485. Source: FDA Drugs@FDA.

Hydroxyzine was approved in 1956, six years before the 1962 Kefauver-Harris amendments introduced the requirement that drugs prove effectiveness — it was approved on safety alone. The FDA's 1956 review was never published, and the modern label contains no trial data of any kind, so nothing about the studies behind the approval can be stated.

The label carries no clinical studies section and reports no trials: no trial counts, durations, participant numbers or comparators appear anywhere on it. Its one statement about systematic evidence is negative — effectiveness as an antianxiety agent for more than 4 months has not been assessed by systematic clinical studies, and the physician is told to reassess the drug's usefulness periodically.

The largest gap on this page. This drug was approved in 1956. That was six years before a 1962 law first made drugs prove they work. So it was approved on safety alone.

The FDA never published its 1956 review. The modern label holds no trial data of any kind. So nothing can be said about the studies behind the approval.

The FDA approved hydroxyzine in 1956. The approved use was easing anxiety and tension tied to nerve-related distress. It also covers added help in physical illness where anxiety shows up. The label covers itching from allergies too, and calming before and after anesthesia. The file number is NDA 010485. The source is Drugs@FDA, the FDA's own database.

The label has no clinical studies section and reports no trials. It gives no trial counts, no lengths, no group sizes, and no comparison drugs.

Its one statement about tested evidence is a negative one. It says use as an anti-anxiety drug beyond 4 months has not been looked at in planned studies. It tells the doctor to check now and then whether the drug is still worth taking.

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. The physician should reassess periodically the usefulness of the drug for the individual patient.

Verbatim from the hydroxyzine FDA label, Indications and Usage section, effective August 27, 2026 — read the full label on DailyMed.

Side effects of hydroxyzine listed on the FDA label

The label reports side effects without incidence figures — no controlled-trial rates appear on it. It characterizes reported side effects as usually mild and transitory; the cardiac and postmarketing items below come from reports with no frequencies attached.

Read the limits first. The label reports side effects with no rates. No trial figures appear on it.

It calls the reported side effects usually mild and short-lived. The heart-related items come from reports with no rates attached. So do the items reported after the drug went on sale.

QT prolongation and Torsade de Pointes on the hydroxyzine label

The hydroxyzine FDA label names QT prolongation and Torsade de Pointes in its Adverse Reactions section, in the list below.

  • Dry mouth
  • Drowsiness (usually transitory)
  • Involuntary motor activity, including rare tremor and convulsions, usually at doses considerably higher than recommended
  • QT prolongation
  • Torsade de Pointes
  • Headache (postmarketing reports)
  • Hallucination (postmarketing reports)
  • Allergic reaction (postmarketing reports)
Side effects reported with the administration of hydroxyzine hydrochloride are usually mild and transitory in nature.

From the hydroxyzine FDA label, Adverse Reactions section, effective August 27, 2026 — DailyMed.

More from the hydroxyzine label: precautions

  • Sedation, driving and the elderly

    Since drowsiness may occur, the label directs that patients be warned against driving a car or operating dangerous machinery and cautioned that the effects of alcohol may be increased. Sedating drugs may cause confusion and over-sedation in the elderly; the label advises starting elderly patients on low doses and observing them closely.

    FDA label, Precautions section.

  • No assessment beyond 4 months

    The label states that hydroxyzine's effectiveness as an antianxiety agent for long-term use — more than 4 months — has not been assessed by systematic clinical studies, and directs the physician to reassess periodically whether the drug remains useful for the individual patient.

    FDA label, Indications and Usage section.

How many Americans take hydroxyzine

Survey-based federal estimates, published with a lag of about two years. They count prescriptions filled, not outcomes.

These are federal survey numbers. They come out about two years late. They count prescriptions filled. They do not tell you if the drug helped.

14,857,241
prescriptions in the United States (2024), refills included
4,680,154
people filling them (2024), ± 641,310 (95%)

Prescriptions are up 90% from 2014 to 2024, a change larger than the survey’s margin of error. Whatever you decide about hydroxyzine, you are deciding alongside about 4,680,154 other people in 2024.

Prescriptions by year: 2014 7,812,729 · 2015 8,297,685 · 2016 8,082,371 · 2017 7,944,928 · 2018 10,431,207 · 2019 9,898,264 · 2020 10,058,837 · 2021 11,643,509 · 2022 13,652,752 · 2023 15,272,377 · 2024 14,857,241.

Prescriptions are up 90 percent since 2014. About 4.7 million people in the United States took it in 2024.

Correction (29 September 2026). An earlier version of this section took its numbers from ClinCalc DrugStats, a third-party site that republishes this survey; we now compute them from AHRQ’s public-use files ourselves.

Source: AHRQ Medical Expenditure Panel Survey (MEPS), Prescribed Medicines public-use files, 2014 (HC-168A) through 2024 (HC-254A), computed by veisund. People with at least one purchase where the Multum generic name (RXDRGNAM) equals the drug, weighted by the year’s person weight; purchases include refills. Standard errors by Taylor linearization on VARSTR/VARPSU. AHRQ’s reliability rule: a year is not shown when fewer than 60 survey respondents reported the drug or the relative standard error is over 50%. AHRQ cautions that its 2018 questionnaire redesign and the 2020–2022 pandemic years make year-to-year comparisons less certain.

What people report to the FDA about hydroxyzine

Read this before the numbers.

Anyone can file an adverse event report — patients, doctors, manufacturers — and nobody verifies that the drug caused what was reported. There is no denominator: tens of millions of prescriptions generate reports at an unknowable rate, and reporting rises with news coverage, not necessarily with harm. Counts below are report volumes, not rates, and cannot be compared between drugs. The FDA itself says not to use this data to make medical decisions — we show it because you deserve to see what is in the public record, with its limits stated plainly.

Read this before the numbers.

Anyone can send a report to the FDA. Patients can. Doctors can. Drug makers can. Nobody checks that the drug caused what the report describes.

There is also no bottom number. Tens of millions of prescriptions turn into reports at a rate nobody knows. Reports go up when a drug is in the news, and that is not the same as more harm.

So these are counts of reports. They are not rates. You cannot use them to compare one drug with another. The FDA itself says not to use this data to make medical choices.

We show it because it is on the public record, and you should get to see it with its limits named.

50,845
reports mentioning hydroxyzine, all time
33,218
filed as serious (a report-level flag covering every drug and outcome in the report)
filed as serious. That flag covers the whole report, and one report can name more than one drug and more than one outcome.

Most-reported reactions

  • Drug ineffective3,485
  • Pruritus3,383
  • Nausea3,067
  • Fatigue2,961
  • Off label use2,620
  • Toxicity to various agents2,567
  • Completed suicide2,544
  • Pain2,510
  • Headache2,453
  • Rash2,274

“Drug ineffective” ranking this high is worth noticing: a report of not being helped counts as an adverse event too, and people file them in large numbers.

It is worth noticing how high “drug ineffective” ranks. A report that the drug did not help counts as an adverse event too. People file a lot of them.

Source: FDA Adverse Event Reporting System (FAERS), via openFDA, openFDA dataset refreshed 2026-07-30 (the refresh date of the query endpoint, not the date reports run through).

Label history: when this label changes, it is recorded in What changed.

Who pays for hydroxyzine

Two claims datasets and one survey, covering different populations with different instruments — they cannot be reconciled by arithmetic, and where their sum crowds the all-payer estimate, that is a finding about the estimates rather than a percentage.

Medicare Part D · claims · 2024Medicaid · claims floor · 2024All-payer · survey · 2024Commercially insured adults · not publishedChildren · no per-drug data
Medicare Part D
Read the under-65 group correctly before the numbers: Medicare before 65 means the disabled and dual-eligible population — among the sickest, highest-need people in the program — and reading their utilization as typical adult use would be a category error. The beneficiary total sums brand-level rows, so treat it as an upper bound on distinct people. 1,889,798 beneficiaries filled 6,278,612 claims in 2024 — 1,218,334 aged 65 and over, and 671,464 under 65.
Medicaid
At least 8,616,838 prescriptions in 2024 — a floor, because 187 of 977 national data rows are suppressed for privacy and contribute zero. Medicaid covers more children than any insurer in the country and publishes no age split — how much of this number is pediatric use is not knowable from public data.
All payers (survey estimate)
A survey estimate from 293 respondents, which we computed from AHRQ’s MEPS 2024 Prescribed Medicines file (people with at least one purchase, weighted; purchases include refills), puts the whole country at 14,857,241 purchases and 4,680,154 people in 2024. Subtracting the public programs from it would produce a number for everyone else — and we do not print that number, because subtracting a survey from claims counts manufactures precision that does not exist.
The population nobody counts
The commercially insured working-age adult — statistically, the likeliest person to be reading this page — is the one population with no public per-drug count anywhere. Private claims data exists and is sold, but nothing a patient can check is published. For children the record is thinner still: no public source counts pediatric use of hydroxyzine specifically; the closest the public record comes is condition-level treatment rates for children, which we have traced for one condition in how childhood ADHD got counted.

Sources: Medicare Part D Prescribers — by Geography and Drug, data.cms.gov, National rows, data year 2024 (published with ~17-month lag). Medicaid State Drug Utilization Data 2024, data.medicaid.gov, national aggregate rows. Retrieved 2026-09-01.

Who has been paying for hydroxyzine, 2019–2024

Medicare Part D

Claims, all ages — the one payer with a public per-drug series.

20192024

3,723,145 → 6,278,612 claims

Medicare under 65

Beneficiaries, not ordinary working-age adults: Medicare before 65 means the disabled and dual-eligible population. A gap is a suppressed split, not zero.

20192024

597,185 → 655,330 beneficiaries

Medicaid

A floor each year — small-cell rows are suppressed federally and excluded from the sum.

20192024

4,890,695 → 8,616,838 prescriptions (floor)

Commercially insured adults

No public dataset publishes per-drug commercial claims for any year — the absence is the finding, and it is rendered, not interpolated. The population this library most wants to inform is the one with no public per-drug series, in any year — insurers and PBMs hold that data privately. What the federal surveys do measure — how many adults take these medications at all — is on the adult-usage page.

Sources: Medicare Part D Prescribers by Geography and Drug (data.cms.gov, national rows, per data year); Medicaid State Drug Utilization Data (data.medicaid.gov, national rows). Claims, fills and beneficiaries are different units — compare each series only with itself.

The hydroxyzine approval, step by step

  1. Step 1

    What the approval was actually based on

    Which studies did the FDA rely on, how long did they run, and who was in them?

    read the label on DailyMed

    Our reading

    Approved in 1956, forty-five years before any rule required a label to print its trials, and with four submissions filed against the application in seventy years. There is no clinical studies section because none was ever required to exist. That is the state of the public record and not a gap in our research. Hydroxyzine is an antihistamine that is sedating, and it is prescribed for anxiety largely because it is not addictive and can be taken as needed — the same shape of argument as buspirone, made about a drug that predates modern trial standards entirely.

  2. Step 2

    The approval

    When was it approved, under what application, and by whose review?

    Approved
    May 31, 1956
    Application
    NDA010485
    Review
    STANDARD
    Holds it now
    Roerig (Pfizer)
    Label submissions since
    4

    Drug applications are bought and sold. The company that holds this one today is often not the company that ran the trials, and where we cannot state the original sponsor from a source we leave it blank rather than guess.

    Source: openFDA Drugs@FDA, original application ORIG-1

  3. Step 3

    What was added after it was on the market

    Which warnings arrived only after millions of people were already taking it?

  4. Step 4

    What independent research has found since

    What has been learned by people who were not selling it?

  5. Step 5

    What still is not known

    Which questions you might reasonably have has nobody answered yet?

    • Approved eight years before the FDA was required to see efficacy evidence at all. What is this prescription actually resting on?
    • The indication is "anxiety and tension associated with psychoneurosis" — language from 1956. It has not been restated in modern diagnostic terms because the label has barely been touched.
    • It is chosen over a benzodiazepine because it is not habit-forming. Compared on effect rather than on risk, what is known?

Does hydroxyzine work for anxiety?

The Cochrane review of five trials, the two largest trials and their margins, and the heart-rhythm warning quoted from the regulator with its dose limits.

Read the evidence review

Deciding about hydroxyzine?

Open hydroxyzine (Vistaril) in veisund

The app has the full approval journey, the resources behind it, and people working through the same questions.

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Browse the evidence library