Drug · FAERS side-effect profile with label screen
Hydroxyzine Pamoate side effects: what 3,609 FDA adverse event reports show
Drug class
Not stated in label
Brand names
Hydroxyzine Hydrochloride
openFDA label
Who reports
3,609 reports · 64% serious · 681 with death outcome · 66% female
openFDA FAERS counts, all years, deduplication not applied
Used for
For symptomatic relief of anxiety and tension associated with psychoneurosis and as an adjunct in organic disease states in which anxiety is manifested. Useful in the management of pruritus due to allergic conditions such as chronic urticaria and atopic and contact dermatoses and in histamine-mediated pruritus.
FDA label, Indications and Usage
What it is
DESCRIPTION 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 0 2 •2HCI M.W. 447.83 Hydroxyzine hydrochloride, USP occurs as a white, odorless powder which is very soluble in water.
FDA label, Description section
Boxed warning
None in the current label
How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation.
Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)?
That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.
Causality screen of the 40 strongest signals
Labeled (related wording) 2Likely indication confounding 2Reporting / coding artifact 3Lab value / disease marker 1Outcome field, not a reaction 1Not in label — unassessed 31
What the badges mean
- Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
- Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
- Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
- Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
- Outcome field, not a reaction Death is a report outcome, not a reaction term. It is dominated by the underlying illness; see the seriousness profile and the boxed warning instead.
- Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.
Strongest disproportionality signals
Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 200 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
Show:
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Respiratory arrest | 117 | 24.5 20.5–29.3ROR 25.3 · χ² 2,611 / p <1e-300 | 24.4 EB05 20.9 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious PRR 22.1 · 97% clinician | no trial data cached |
| Completed suicide (death by suicide) | 307 | 21.3 19.1–23.7ROR 23.2 · χ² 5,913 / p <1e-300 | 21.2 EB05 19.3 · IC025 +4.2 3/3 methods agree | Outcome field, not a reaction | serious PRR 19.1 · 99% clinician | no trial data cached |
| Economic problem | 28 | 10.6 7.3–15.3ROR 10.6 · χ² 233 / p 7e-53 | 9.9 EB05 6.9 · IC025 +2.5 3/3 methods agree | Reporting / coding artifact | serious PRR 9.6 · ♀ 36% (drug 66%) | no trial data cached |
| Impaired quality of life | 24 | 9.7 6.5–14.5ROR 9.8 · χ² 179 / p 5e-41 | 8.8 EB05 6.0 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 4.9 | no trial data cached |
| Drug abuse | 136 | 9.5 8.0–11.2ROR 9.8 · χ² 1,023 / p 1e-224 | 9.3 EB05 8.0 · IC025 +2.9 3/3 methods agree | Reporting / coding artifact | serious PRR 8.6 · ♀ 44% (drug 66%) · 98% clinician | no trial data cached |
| Scratch | 16 | 9.0 5.5–14.7ROR 9.0 · χ² 106 / p 4e-25 | 7.7 EB05 4.8 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious n=15 | no trial data cached |
| Cardiac arrest (heart stopping) | 125 | 8.8 7.4–10.4ROR 9.1 · χ² 856 / p 2e-188 | 8.6 EB05 7.4 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 7.9 · 97% clinician | no trial data cached |
| Bipolar disorder | 16 | 8.5 5.2–13.9ROR 8.5 · χ² 98 / p 2e-23 | 7.2 EB05 4.6 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 8.8 | no trial data cached |
| Impaired gastric emptying | 18 | 8.2 5.2–13.0ROR 8.2 · χ² 107 / p 2e-25 | 7.1 EB05 4.6 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 8.3 | no trial data cached |
| Chronic kidney disease | 106 | 8.0 6.7–9.7ROR 8.3 · χ² 648 / p 3e-143 | 7.8 EB05 6.6 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 7.3 | no trial data cached |
| Sleep disorder due to a general medical condition | 22 | 7.9 5.2–12.0ROR 8.0 · χ² 126 / p 2e-29 | 7.0 EB05 4.8 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 1.9 · 91% clinician | no trial data cached |
| Hyperlipidaemia | 15 | 7.3 4.4–12.1ROR 7.3 · χ² 75 / p 2e-18 | 6.1 EB05 3.9 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 7.2 | no trial data cached |
| Autoimmune disorder | 11 | 6.7 3.7–12.1ROR 6.7 · χ² 48 / p 3e-12 | 5.4 EB05 3.2 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 6.4 | no trial data cached |
| End stage renal disease | 21 | 6.6 4.3–10.2ROR 6.7 · χ² 95 / p 1e-22 | 5.9 EB05 4.0 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 6.0 | no trial data cached |
| Anhedonia | 29 | 6.4 4.4–9.2ROR 6.4 · χ² 126 / p 2e-29 | 5.8 EB05 4.2 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 5.7 · ♀ 28% (drug 66%) | no trial data cached |
| Dental caries | 12 | 6.3 3.6–11.1ROR 6.3 · χ² 48 / p 2e-12 | 5.2 EB05 3.2 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 8.8 | no trial data cached |
| Skin reaction | 15 | 6.2 3.7–10.3ROR 6.2 · χ² 60 / p 4e-15 | 5.3 EB05 3.4 · IC025 +1.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 8.2 | no trial data cached |
| Obesity | 17 | 6.2 3.9–10.0ROR 6.2 · χ² 69 / p 5e-17 | 5.4 EB05 3.5 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 5.7 | no trial data cached |
| Drug hypersensitivity | 200 | 6.0 5.2–6.9ROR 6.3 · χ² 833 / p 2e-183 | 5.9 EB05 5.2 · IC025 +2.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.9 | no trial data cached |
| Temperature intolerance | 10 | 5.7 3.1–10.6ROR 5.7 · χ² 34 / p 3e-9 | 4.6 EB05 2.7 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious n=7 | no trial data cached |
| Seasonal allergy | 13 | 5.4 3.1–9.2ROR 5.4 · χ² 42 / p 5e-11 | 4.6 EB05 2.9 · IC025 +1.3 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=8 | no trial data cached |
| Encephalopathy | 22 | 5.2 3.4–7.9ROR 5.2 · χ² 71 / p 2e-17 | 4.7 EB05 3.3 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 4.7 · 95% clinician | no trial data cached |
| Intentional dose omission | 24 | 5.1 3.4–7.6ROR 5.1 · χ² 75 / p 2e-18 | 4.7 EB05 3.3 · IC025 +1.6 3/3 methods agree | Reporting / coding artifact | serious PRR 6.3 | no trial data cached |
| Carpal tunnel syndrome | 12 | 5.0 2.8–8.7ROR 5.0 · χ² 34 / p 3e-9 | 4.2 EB05 2.6 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 5.5 | no trial data cached |
| Mental disorder | 37 | 4.9 3.6–6.8ROR 5.0 · χ² 112 / p 2e-26 | 4.7 EB05 3.5 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 5.0 | no trial data cached |
| Eating disorder | 18 | 4.9 3.1–7.8ROR 4.9 · χ² 52 / p 3e-13 | 4.4 EB05 2.9 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 4.1 | no trial data cached |
| Tubulointerstitial nephritis | 15 | 4.7 2.8–7.7ROR 4.7 · χ² 39 / p 2e-10 | 4.1 EB05 2.7 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 4.2 | no trial data cached |
| Type 2 diabetes mellitus | 27 | 4.6 3.2–6.8ROR 4.7 · χ² 74 / p 4e-18 | 4.3 EB05 3.1 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 4.1 | no trial data cached |
| Hiatus hernia | 10 | 4.5 2.4–8.3ROR 4.5 · χ² 24 / p 6e-7 | 3.8 EB05 2.2 · IC025 +0.9 3/3 methods agree | Not in label — unassessed | serious PRR 3.7 | no trial data cached |
| Hunger | 10 | 4.3 2.3–8.0ROR 4.3 · χ² 22 / p 1e-6 | 3.7 EB05 2.2 · IC025 +0.8 3/3 methods agree | Not in label — unassessed | serious n=7 | no trial data cached |
| Foot fracture | 14 | 4.3 2.5–7.2ROR 4.3 · χ² 32 / p 8e-9 | 3.8 EB05 2.4 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 4.3 | no trial data cached |
| Renal injury | 22 | 4.3 2.8–6.5ROR 4.3 · χ² 52 / p 3e-13 | 3.9 EB05 2.8 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 3.8 | no trial data cached |
| Haemorrhoids | 14 | 4.2 2.5–7.0ROR 4.2 · χ² 31 / p 2e-8 | 3.7 EB05 2.4 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 3.3 | no trial data cached |
| Ankle fracture | 11 | 4.1 2.3–7.4ROR 4.1 · χ² 23 / p 8e-7 | 3.6 EB05 2.2 · IC025 +0.8 3/3 methods agree | Not in label — unassessed | serious PRR 3.4 | no trial data cached |
| Urticaria (hives) | 116 | 4.1 3.4–4.8ROR 4.2 · χ² 266 / p 5e-60 | 4.0 EB05 3.4 · IC025 +1.7 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 5.3 | no trial data cached |
| Brain fog | 10 | 4.0 2.1–7.4ROR 4.0 · χ² 19 / p 5e-6 | 3.4 EB05 2.0 · IC025 +0.7 3/3 methods agree | Not in label — unassessed | serious PRR 4.1 | no trial data cached |
| Rib fracture | 14 | 4.0 2.3–6.7ROR 4.0 · χ² 28 / p 6e-8 | 3.6 EB05 2.3 · IC025 +0.9 3/3 methods agree | Not in label — unassessed | serious PRR 3.9 | no trial data cached |
| Sleep disorder | 47 | 3.9 2.9–5.2ROR 3.9 · χ² 99 / p 1e-23 | 3.8 EB05 3.0 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 2.0 | no trial data cached |
| Limb injury | 18 | 3.9 2.4–6.1ROR 3.9 · χ² 35 / p 1e-9 | 3.6 EB05 2.4 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 4.0 | no trial data cached |
| Haematocrit decreased | 13 | 3.8 2.2–6.5ROR 3.8 · χ² 24 / p 5e-7 | 3.4 EB05 2.1 · IC025 +0.8 3/3 methods agree | Lab value / disease marker | serious PRR 3.5 | no trial data cached |
Trial evidence (ClinicalTrials.gov)
Trial cross-check not yet run for this drug (ClinicalTrials.gov pull covers the 800 most-reported drugs first).
Most frequently reported reactions
By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Completed suicide (death by suicide) | 307 | 21.3 19.1–23.7ROR 23.2 · χ² 5,913 / p <1e-300 | 21.2 EB05 19.3 · IC025 +4.2 3/3 methods agree | Outcome field, not a reaction | serious PRR 19.1 · 99% clinician | no trial data cached |
| Drug hypersensitivity | 200 | 6.0 5.2–6.9ROR 6.3 · χ² 833 / p 2e-183 | 5.9 EB05 5.2 · IC025 +2.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.9 | no trial data cached |
| Anxiety | 166 | 3.4 2.9–3.9ROR 3.5 · χ² 280 / p 4e-63 | 3.4 EB05 2.9 · IC025 +1.5 3/3 methods agree | Likely indication confounding term in indications | serious PRR 3.5 | no trial data cached |
| Pruritus (itching) | 162 | 2.5 2.1–2.9ROR 2.6 · χ² 146 / p 8e-34 | 2.5 EB05 2.2 · IC025 +1.1 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 3.2 | no trial data cached |
| Drug abuse | 136 | 9.5 8.0–11.2ROR 9.8 · χ² 1,023 / p 1e-224 | 9.3 EB05 8.0 · IC025 +2.9 3/3 methods agree | Reporting / coding artifact | serious PRR 8.6 · ♀ 44% (drug 66%) · 98% clinician | no trial data cached |
| Cardiac arrest (heart stopping) | 125 | 8.8 7.4–10.4ROR 9.1 · χ² 856 / p 2e-188 | 8.6 EB05 7.4 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 7.9 · 97% clinician | no trial data cached |
| Respiratory arrest | 117 | 24.5 20.5–29.3ROR 25.3 · χ² 2,611 / p <1e-300 | 24.4 EB05 20.9 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious PRR 22.1 · 97% clinician | no trial data cached |
| Urticaria (hives) | 116 | 4.1 3.4–4.8ROR 4.2 · χ² 266 / p 5e-60 | 4.0 EB05 3.4 · IC025 +1.7 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 5.3 | no trial data cached |
| Depression | 113 | 2.9 2.4–3.4ROR 2.9 · χ² 138 / p 4e-32 | 2.8 EB05 2.4 · IC025 +1.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.8 | no trial data cached |
| Product dose omission issue | 108 | 2.2 1.8–2.7ROR 2.2 · χ² 71 / p 2e-17 | 2.2 EB05 1.9 · IC025 +0.8 | Reporting / coding artifact | serious PRR 3.6 | no trial data cached |
| Chronic kidney disease | 106 | 8.0 6.7–9.7ROR 8.3 · χ² 648 / p 3e-143 | 7.8 EB05 6.6 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 7.3 | no trial data cached |
| Acute kidney injury (sudden kidney damage) | 93 | 3.5 2.9–4.3ROR 3.6 · χ² 169 / p 7e-39 | 3.5 EB05 2.9 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 3.2 | no trial data cached |
| Renal failure (kidney failure) | 87 | 3.8 3.1–4.7ROR 3.8 · χ² 176 / p 2e-40 | 3.7 EB05 3.1 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 3.4 | no trial data cached |
| Toxicity to various agents | 66 | 2.3 1.8–2.9ROR 2.3 · χ² 47 / p 4e-12 | 2.3 EB05 1.8 · IC025 +0.8 | Not in label — unassessed | serious PRR 2.1 · 91% clinician | no trial data cached |
| Illness | 59 | 3.4 2.6–4.4ROR 3.5 · χ² 99 / p 1e-23 | 3.3 EB05 2.7 · IC025 +1.3 3/3 methods agree | Reporting / coding artifact | serious PRR 4.9 | no trial data cached |
Unlabeled candidate signals
These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.
- Respiratory arrest — n=117, PRR 24.5
- Impaired quality of life — n=24, PRR 9.7
- Cardiac arrest — n=125, PRR 8.8
- Chronic kidney disease — n=106, PRR 8.0
- Sleep disorder due to a general medical condition — n=22, PRR 7.9
- End stage renal disease — n=21, PRR 6.6
- Anhedonia — n=29, PRR 6.4
- Encephalopathy — n=22, PRR 5.2
- Mental disorder — n=37, PRR 4.9
- Type 2 diabetes mellitus — n=27, PRR 4.6
Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.
Common questions
What are the most reported side effects of Hydroxyzine?
In FDA FAERS, the most frequently co-reported reaction terms for Hydroxyzine are drug hypersensitivity, anxiety, pruritus, cardiac arrest, respiratory arrest, urticaria. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.
Does Hydroxyzine have an FDA boxed warning?
No. The FDA label retrieved for Hydroxyzine has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Hydroxyzine causes these side effects?
No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.
Sources & methods
- FDA label via openFDA (set ID 89901966-724b-4773-98b8-ea663ceabd53, effective 20241025; matched on
openfda.generic_name.exact:"HYDROXYZINE") - Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
- FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA
count=aggregation, fieldpatient.drug.openfda.generic_name.exact, 240 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction - Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
- Seriousness and sex counts from openFDA
count=serious,patient.patientsex,seriousnessdeath
Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.