Drug · FAERS side-effect profile with label screen
Cetirizine side effects: what 9,103 FDA adverse event reports show
Drug class
Not stated in label
Brand names
Cetirizine Hydrochloride
openFDA label
Who reports
9,103 reports · 55% serious · 413 with death outcome · 65% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Perennial Allergic Rhinitis: Cetirizine hydrochloride is indicated for the relief of symptoms associated with perennial allergic rhinitis due to allergens such as dust mites, animal dander and molds in children 6 to 23 months of age. Symptoms treated effectively include sneezing, rhinorrhea, postnasal discharge, nasal pruritus, ocular pruritus, and tearing.
FDA label, Indications and Usage
What it is
DESCRIPTION Cetirizine hydrochloride is an orally active and selective H 1 -receptor antagonist.
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) 6Likely indication confounding 6Reporting / coding artifact 6Not in label — unassessed 22
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.
- 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. 1,031 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 |
|---|---|---|---|---|---|---|
| Infusion site discharge | 37 | 50.8 36.7–70.4ROR 51.0 · χ² 1,720 / p <1e-300 | 48.6 EB05 36.8 · IC025 +4.4 3/3 methods agree | Likely indication confounding term in indications | serious n=27 · 89% consumer | no trial data cached |
| Device maintenance issue | 12 | 49.9 28.2–88.5ROR 50.0 · χ² 516 / p 1e-114 | 45.6 EB05 27.8 · IC025 +3.1 3/3 methods agree | Reporting / coding artifact | – | no trial data cached |
| Injection site burning | 12 | 35.4 20.0–62.7ROR 35.5 · χ² 362 / p 4e-81 | 33.2 EB05 20.2 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | – | no trial data cached |
| Infusion site mass | 16 | 35.0 21.3–57.3ROR 35.0 · χ² 487 / p 3e-108 | 33.2 EB05 21.7 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Infusion site haemorrhage | 39 | 28.0 20.4–38.4ROR 28.1 · χ² 977 / p 1e-214 | 27.3 EB05 20.9 · IC025 +3.8 3/3 methods agree | Labeled (related wording) related wording | serious n=23 · 87% consumer | no trial data cached |
| Device infusion issue | 26 | 24.7 16.8–36.3ROR 24.7 · χ² 561 / p 3e-124 | 24.0 EB05 17.2 · IC025 +3.4 3/3 methods agree | Reporting / coding artifact | serious n=13 · 100% consumer | no trial data cached |
| Infusion site induration | 15 | 24.5 14.7–40.8ROR 24.6 · χ² 312 / p 4e-70 | 23.6 EB05 15.0 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious n=6 | no trial data cached |
| Infusion site irritation | 13 | 24.3 14.1–41.9ROR 24.3 · χ² 265 / p 8e-60 | 23.2 EB05 14.2 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious n=6 | no trial data cached |
| Obstructive sleep apnoea syndrome | 13 | 21.6 12.5–37.3ROR 21.6 · χ² 233 / p 6e-53 | 20.6 EB05 12.5 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious n=12 | no trial data cached |
| Infusion site infection | 21 | 21.5 14.0–33.0ROR 21.5 · χ² 387 / p 2e-86 | 20.9 EB05 14.3 · IC025 +3.1 3/3 methods agree | Labeled (related wording) related wording | serious n=8 | no trial data cached |
| Infusion site swelling | 57 | 21.5 16.6–27.9ROR 21.6 · χ² 1,083 / p 1e-237 | 21.2 EB05 16.9 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious n=26 · 88% consumer | no trial data cached |
| Infusion site warmth | 10 | 19.3 10.3–35.9ROR 19.3 · χ² 154 / p 1e-35 | 17.9 EB05 9.4 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious n=5 | no trial data cached |
| Infusion site erythema | 68 | 19.0 15.0–24.1ROR 19.1 · χ² 1,133 / p 9e-249 | 18.8 EB05 15.3 · IC025 +3.7 3/3 methods agree | Labeled (related wording) related wording | serious n=28 · 84% consumer | no trial data cached |
| Seasonal allergy | 110 | 18.1 15.0–21.8ROR 18.3 · χ² 1,742 / p <1e-300 | 17.9 EB05 15.2 · IC025 +3.7 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=59 · 90% consumer | no trial data cached |
| Eyelid pain | 15 | 17.9 10.8–29.8ROR 17.9 · χ² 221 / p 3e-50 | 17.1 EB05 10.5 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | – | no trial data cached |
| Infusion site pruritus | 24 | 17.8 11.9–26.6ROR 17.9 · χ² 362 / p 5e-81 | 17.4 EB05 12.1 · IC025 +3.0 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious n=18 · 88% consumer | no trial data cached |
| Infusion site pain | 97 | 17.6 14.4–21.5ROR 17.8 · χ² 1,491 / p <1e-300 | 17.4 EB05 14.7 · IC025 +3.7 3/3 methods agree | Labeled (related wording) related wording | serious n=43 · 90% consumer | no trial data cached |
| Mast cell activation syndrome | 10 | 17.5 9.4–32.6ROR 17.5 · χ² 138 / p 3e-32 | 16.0 EB05 8.1 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Infusion site bruising | 16 | 17.4 10.7–28.5ROR 17.5 · χ² 230 / p 3e-52 | 16.7 EB05 10.4 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious n=13 | no trial data cached |
| Product administration interrupted | 54 | 16.3 12.5–21.3ROR 16.4 · χ² 755 / p 2e-166 | 16.1 EB05 12.7 · IC025 +3.4 3/3 methods agree | Reporting / coding artifact | serious n=47 | no trial data cached |
| Cataplexy | 10 | 16.2 8.7–30.2ROR 16.2 · χ² 127 / p 1e-29 | 14.6 EB05 7.3 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious n=6 | no trial data cached |
| Multiple allergies | 54 | 15.9 12.2–20.8ROR 16.0 · χ² 736 / p 2e-162 | 15.7 EB05 12.4 · IC025 +3.3 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=42 · 76% consumer | no trial data cached |
| Device alarm issue | 10 | 12.8 6.9–23.9ROR 12.8 · χ² 97 / p 4e-23 | 10.8 EB05 5.4 · IC025 +2.0 3/3 methods agree | Reporting / coding artifact | – | no trial data cached |
| Pre-existing condition improved | 31 | 11.3 8.0–16.1ROR 11.4 · χ² 281 / p 2e-63 | 10.7 EB05 7.7 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious n=18 | no trial data cached |
| Device power source issue | 14 | 11.3 6.7–19.1ROR 11.3 · χ² 121 / p 2e-28 | 9.8 EB05 5.7 · IC025 +2.2 3/3 methods agree | Reporting / coding artifact | – | no trial data cached |
| Nasal disorder | 13 | 11.3 6.5–19.4ROR 11.3 · χ² 111 / p 3e-26 | 9.6 EB05 5.5 · IC025 +2.1 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious n=9 | no trial data cached |
| Sleep disorder due to a general medical condition | 72 | 10.3 8.2–12.9ROR 10.4 · χ² 592 / p 5e-131 | 10.0 EB05 8.1 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 3.5 | no trial data cached |
| Dermatitis contact | 48 | 9.8 7.4–12.9ROR 9.8 · χ² 367 / p 4e-82 | 9.3 EB05 7.2 · IC025 +2.7 3/3 methods agree | Labeled (related wording) related wording | serious n=30 · 83% consumer | no trial data cached |
| Rhinovirus infection | 16 | 9.7 6.0–15.9ROR 9.7 · χ² 116 / p 2e-27 | 8.4 EB05 5.2 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious n=15 | no trial data cached |
| Infusion site reaction | 12 | 9.5 5.4–16.8ROR 9.5 · χ² 83 / p 4e-20 | 7.8 EB05 4.5 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious n=5 | no trial data cached |
| Incorrect drug administration rate | 16 | 8.7 5.3–14.3ROR 8.7 · χ² 102 / p 3e-24 | 7.4 EB05 4.7 · IC025 +2.0 3/3 methods agree | Reporting / coding artifact | serious n=12 | no trial data cached |
| Maternal drugs affecting foetus | 29 | 8.6 6.0–12.4ROR 8.6 · χ² 187 / p 6e-43 | 7.9 EB05 5.6 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 9.4 · 100% clinician | no trial data cached |
| Multiple drug overdose intentional | 12 | 8.5 4.8–15.0ROR 8.5 · χ² 72 / p 1e-17 | 6.9 EB05 4.0 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious n=12 | no trial data cached |
| Insurance issue | 53 | 8.2 6.3–10.8ROR 8.3 · χ² 328 / p 1e-73 | 7.8 EB05 6.1 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 15.7 · 79% consumer | no trial data cached |
| Scratch | 33 | 7.3 5.2–10.3ROR 7.4 · χ² 174 / p 4e-40 | 6.8 EB05 5.0 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious n=6 | no trial data cached |
| Paranasal sinus discomfort | 12 | 7.3 4.2–12.9ROR 7.4 · χ² 59 / p 6e-15 | 6.0 EB05 3.6 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | – | no trial data cached |
| Upper-airway cough syndrome | 26 | 7.3 5.0–10.7ROR 7.3 · χ² 135 / p 2e-31 | 6.6 EB05 4.7 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious n=13 | no trial data cached |
| Rhinitis allergic | 14 | 7.3 4.3–12.3ROR 7.3 · χ² 69 / p 4e-17 | 6.1 EB05 3.8 · IC025 +1.7 3/3 methods agree | Likely indication confounding term in indications | serious n=12 | no trial data cached |
| Snoring | 11 | 6.7 3.7–12.1ROR 6.7 · χ² 48 / p 2e-12 | 5.4 EB05 3.2 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious n=6 | no trial data cached |
| Ear infection | 75 | 6.5 5.2–8.2ROR 6.6 · χ² 344 / p 4e-77 | 6.3 EB05 5.2 · IC025 +2.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 7.1 | 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 |
|---|---|---|---|---|---|---|
| Fatigue (tiredness) | 656 | 1.9 1.8–2.1ROR 2.0 · χ² 310 / p 9e-70 | 1.9 EB05 1.8 · IC025 +0.8 | Labeled adverse reaction exact term | serious PRR 1.9 | no trial data cached |
| Nausea | 574 | 1.7 1.5–1.8ROR 1.7 · χ² 161 / p 4e-37 | 1.7 EB05 1.6 · IC025 +0.6 | Labeled adverse reaction exact term | serious PRR 2.1 | no trial data cached |
| Headache | 529 | 1.9 1.8–2.1ROR 2.0 · χ² 249 / p 2e-56 | 1.9 EB05 1.8 · IC025 +0.8 | Labeled adverse reaction exact term | serious PRR 2.2 | no trial data cached |
| Diarrhoea (diarrhea) | 505 | 1.8 1.7–2.0ROR 1.9 · χ² 187 / p 9e-43 | 1.8 EB05 1.7 · IC025 +0.7 | Labeled adverse reaction exact term | serious PRR 1.8 | no trial data cached |
| Dyspnoea (shortness of breath) | 491 | 2.0 1.8–2.2ROR 2.1 · χ² 250 / p 1e-56 | 2.0 EB05 1.9 · IC025 +0.8 | Labeled adverse reaction exact term | serious PRR 2.0 | no trial data cached |
| Pruritus (itching) | 458 | 2.8 2.6–3.0ROR 2.9 · χ² 533 / p 3e-118 | 2.8 EB05 2.6 · IC025 +1.3 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 3.3 | no trial data cached |
| Drug ineffective (drug did not work) | 429 | 0.7 0.7–0.8ROR 0.7 · χ² 38 / p 3e-10 | 0.7 EB05 0.7 · IC025 -0.6 PRR-only: not supported by EBGM or IC | Reporting / coding artifact | serious PRR 0.9 | no trial data cached |
| Pain | 408 | 1.5 1.4–1.7ROR 1.5 · χ² 75 / p 2e-18 | 1.5 EB05 1.4 · IC025 +0.4 | Labeled adverse reaction exact term | serious PRR 1.7 | no trial data cached |
| Cough | 397 | 3.3 3.0–3.6ROR 3.4 · χ² 630 / p 3e-139 | 3.3 EB05 3.0 · IC025 +1.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.0 | no trial data cached |
| Product dose omission issue | 390 | 3.2 2.9–3.5ROR 3.2 · χ² 578 / p 4e-128 | 3.1 EB05 2.9 · IC025 +1.5 3/3 methods agree | Reporting / coding artifact | serious PRR 5.8 | no trial data cached |
| Rash | 374 | 2.0 1.8–2.2ROR 2.0 · χ² 185 / p 2e-42 | 2.0 EB05 1.8 · IC025 +0.8 | Labeled adverse reaction exact term | serious PRR 1.8 | no trial data cached |
| Dizziness | 364 | 1.7 1.5–1.9ROR 1.7 · χ² 102 / p 2e-24 | 1.7 EB05 1.5 · IC025 +0.6 | Not in label — unassessed | serious PRR 1.8 | no trial data cached |
| Off label use (used outside approved label) | 316 | 0.8 0.8–0.9ROR 0.8 · χ² 10 / p 7e-4 | 0.8 EB05 0.8 · IC025 -0.4 PRR-only: not supported by EBGM or IC | Reporting / coding artifact | serious PRR 0.9 | no trial data cached |
| Arthralgia (joint pain) | 302 | 1.7 1.5–1.9ROR 1.7 · χ² 83 / p 3e-20 | 1.7 EB05 1.5 · IC025 +0.6 | Labeled adverse reaction exact term | serious PRR 1.8 | no trial data cached |
| Vomiting | 295 | 1.4 1.3–1.6ROR 1.5 · χ² 41 / p 7e-11 | 1.4 EB05 1.3 · IC025 +0.3 | Labeled adverse reaction exact term | serious PRR 1.5 | 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.
- Infusion site swelling — n=57, PRR 21.5
- Pre-existing condition improved — n=31, PRR 11.3
- Sleep disorder due to a general medical condition — n=72, PRR 10.3
- Maternal drugs affecting foetus — n=29, PRR 8.6
- Insurance issue — n=53, PRR 8.2
- Scratch — n=33, PRR 7.3
- Upper-airway cough syndrome — n=26, PRR 7.3
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 Cetirizine?
In FDA FAERS, the most frequently co-reported reaction terms for Cetirizine are fatigue, nausea, headache, diarrhoea, dyspnoea, pruritus. 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 Cetirizine have an FDA boxed warning?
No. The FDA label retrieved for Cetirizine has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Cetirizine 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 365cbabe-535b-4c34-852b-6cd63782e3e5, effective 20250501; matched on
openfda.generic_name.exact:"CETIRIZINE") - 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, 1,071 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.