Drug · FAERS side-effect profile with label screen
Cetiirizine side effects: what 42,091 FDA adverse event reports show
Drug class
Not stated in label
Brand names
Cetirizine
openFDA label
Who reports
42,091 reports · 80% serious · 4,934 with death outcome · 68% female
openFDA FAERS counts, all years, deduplication not applied
Used for
temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: ■ runny nose ■ sneezing ■ itchy, watery eyes ■ itching of the nose or throat
FDA label, Indications and Usage
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
Lab value / disease marker 7No label text to screen 33
What the badges mean
- 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.
- 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.
- No label text to screen No validated FDA label was retrievable for this product, so the screen could not run. Disproportionality only.
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. 1,166 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 |
|---|---|---|---|---|---|---|
| Amyloid arthropathy | 56 | 3,433.2 1,636.8–7,201.1ROR 3,437.8 · χ² 23,590 / p <1e-300 | 374.8 EB05 299.4 · IC025 +6.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=56 · ♀ 100% (drug 68%) · 100% clinician | no trial arm names this drug |
| Radiation inflammation | 36 | 401.3 258.3–623.3ROR 401.6 · χ² 7,687 / p <1e-300 | 198.0 EB05 149.5 · IC025 +5.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=36 · ♀ 0% (drug 68%) | no trial arm names this drug |
| Grip strength | 98 | 366.9 282.5–476.6ROR 367.8 · χ² 20,248 / p <1e-300 | 202.1 EB05 170.7 · IC025 +6.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=98 · ♀ 100% (drug 68%) · 100% clinician | no trial arm names this drug |
| C-reactive protein | 358 | 326.4 285.6–372.9ROR 329.2 · χ² 69,533 / p <1e-300 | 194.3 EB05 178.0 · IC025 +7.1 3/3 methods agree | Lab value / disease marker | serious n=358 · ♀ 100% (drug 68%) · 96% clinician | no trial arm names this drug |
| Vaginal flatulence | 118 | 314.5 249.7–396.2ROR 315.4 · χ² 22,279 / p <1e-300 | 186.3 EB05 159.7 · IC025 +6.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=118 · ♀ 100% (drug 68%) | no trial arm names this drug |
| Swollen joint count | 89 | 283.4 218.4–367.9ROR 284.0 · χ² 15,696 / p <1e-300 | 173.4 EB05 145.2 · IC025 +6.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=89 · ♀ 100% (drug 68%) · 100% clinician | no trial arm names this drug |
| Duodenal ulcer perforation | 2,619 | 277.6 264.9–291.0ROR 296.0 · χ² 460,916 / p <1e-300 | 177.4 EB05 171.8 · IC025 +7.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 128.2 · ♀ 100% (drug 68%) · 93% clinician | no trial arm names this drug |
| Facet joint syndrome | 1,090 | 264.4 245.8–284.4ROR 271.4 · χ² 185,689 / p <1e-300 | 171.6 EB05 163.2 · IC025 +7.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=1,090 · ♀ 100% (drug 68%) · 95% clinician | no trial arm names this drug |
| Deep vein thrombosis postoperative | 675 | 262.5 239.2–288.1ROR 266.8 · χ² 114,388 / p <1e-300 | 170.5 EB05 160.0 · IC025 +7.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=675 · ♀ 100% (drug 68%) · 92% clinician | no trial arm names this drug |
| Anti-cyclic citrullinated peptide antibody positive | 2,391 | 253.6 241.6–266.2ROR 268.8 · χ² 396,518 / p <1e-300 | 167.3 EB05 161.7 · IC025 +7.3 3/3 methods agree | Lab value / disease marker | serious PRR 121.5 · ♀ 100% (drug 68%) · 93% clinician | no trial arm names this drug |
| Swollen joint count increased | 1,043 | 251.2 233.3–270.6ROR 257.6 · χ² 171,767 / p <1e-300 | 166.0 EB05 157.7 · IC025 +7.2 3/3 methods agree | Lab value / disease marker | serious n=1,043 · ♀ 100% (drug 68%) · 96% clinician | no trial arm names this drug |
| Rheumatic fever | 1,422 | 241.3 226.6–257.0ROR 249.7 · χ² 227,979 / p <1e-300 | 161.7 EB05 154.8 · IC025 +7.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=1,422 · ♀ 100% (drug 68%) · 95% clinician | no trial arm names this drug |
| Lupus vulgaris | 373 | 228.1 201.8–257.8ROR 230.1 · χ² 57,414 / p <1e-300 | 154.8 EB05 142.0 · IC025 +6.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=373 · ♀ 100% (drug 68%) · 95% clinician | no trial arm names this drug |
| Muscle injury | 2,468 | 214.9 205.2–225.1ROR 228.2 · χ² 365,335 / p <1e-300 | 149.6 EB05 144.7 · IC025 +7.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 117.2 · ♀ 100% (drug 68%) · 94% clinician | no trial arm names this drug |
| Sleep disorder due to general medical condition, insomnia type | 1,834 | 199.0 188.6–209.9ROR 208.0 · χ² 256,921 / p <1e-300 | 141.6 EB05 136.3 · IC025 +7.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=1,830 · ♀ 100% (drug 68%) · 94% clinician | no trial arm names this drug |
| Anti-cyclic citrullinated peptide antibody | 187 | 194.3 164.1–230.1ROR 195.2 · χ² 25,620 / p <1e-300 | 137.5 EB05 121.8 · IC025 +6.4 3/3 methods agree | Lab value / disease marker | serious n=187 · ♀ 100% (drug 68%) · 95% clinician | no trial arm names this drug |
| Subcutaneous drug absorption impaired | 150 | 189.6 157.1–228.9ROR 190.3 · χ² 20,160 / p <1e-300 | 134.7 EB05 117.6 · IC025 +6.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=150 · ♀ 100% (drug 68%) · 100% clinician | no trial arm names this drug |
| Cardiospasm | 152 | 186.8 155.0–225.2ROR 187.5 · χ² 20,212 / p <1e-300 | 133.3 EB05 116.5 · IC025 +6.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=151 | no trial arm names this drug |
| Folliculitis | 2,726 | 179.0 171.5–186.8ROR 191.3 · χ² 353,550 / p <1e-300 | 131.3 EB05 127.2 · IC025 +6.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 111.6 · ♀ 99% (drug 68%) · 94% clinician | no trial arm names this drug |
| Adjustment disorder with depressed mood | 523 | 174.9 158.3–193.1ROR 177.0 · χ² 66,523 / p <1e-300 | 128.6 EB05 119.6 · IC025 +6.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=522 · ♀ 100% (drug 68%) · 96% clinician | no trial arm names this drug |
| Helicobacter infection | 2,537 | 165.4 158.2–172.8ROR 175.9 · χ² 309,974 / p <1e-300 | 123.8 EB05 119.8 · IC025 +6.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 94.6 · ♀ 100% (drug 68%) · 93% clinician | no trial arm names this drug |
| Pemphigus | 2,938 | 154.4 148.3–160.8ROR 165.9 · χ² 340,661 / p <1e-300 | 117.6 EB05 114.1 · IC025 +6.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 85.3 · ♀ 100% (drug 68%) · 90% clinician | no trial arm names this drug |
| Dislocation of vertebra | 509 | 148.0 134.1–163.3ROR 149.8 · χ² 56,977 / p <1e-300 | 113.4 EB05 105.4 · IC025 +6.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=509 · ♀ 100% (drug 68%) · 94% clinician | no trial arm names this drug |
| Immunisation | 96 | 141.8 113.0–177.9ROR 142.1 · χ² 10,303 / p <1e-300 | 107.9 EB05 91.0 · IC025 +5.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=96 | no trial arm names this drug |
| Rheumatoid factor positive | 1,277 | 141.8 133.3–150.8ROR 146.2 · χ² 138,393 / p <1e-300 | 110.0 EB05 105.0 · IC025 +6.6 3/3 methods agree | Lab value / disease marker | serious n=1,277 · ♀ 100% (drug 68%) · 96% clinician | no trial arm names this drug |
| Hepatic enzyme | 30 | 136.2 90.9–204.1ROR 136.3 · χ² 3,047 / p <1e-300 | 100.2 EB05 73.6 · IC025 +4.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=30 · ♀ 100% (drug 68%) · 100% clinician | no trial arm names this drug |
| X-ray abnormal | 377 | 133.5 119.2–149.5ROR 134.7 · χ² 38,870 / p <1e-300 | 104.6 EB05 96.0 · IC025 +6.4 3/3 methods agree | Lab value / disease marker | serious n=377 · ♀ 100% (drug 68%) · 96% clinician | no trial arm names this drug |
| Hand deformity | 2,710 | 130.3 125.0–135.8ROR 139.2 · χ² 274,743 / p <1e-300 | 103.1 EB05 99.9 · IC025 +6.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 81.1 · ♀ 100% (drug 68%) · 92% clinician | no trial arm names this drug |
| Palmoplantar keratoderma | 146 | 126.7 105.7–152.0ROR 127.2 · χ² 14,373 / p <1e-300 | 99.6 EB05 86.8 · IC025 +6.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=146 | no trial arm names this drug |
| Peripheral venous disease | 793 | 123.5 114.3–133.4ROR 125.9 · χ² 76,895 / p <1e-300 | 98.6 EB05 93.0 · IC025 +6.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=793 · ♀ 100% (drug 68%) · 95% clinician | no trial arm names this drug |
| Hypocholesterolaemia | 61 | 123.1 93.0–163.0ROR 123.3 · χ² 5,809 / p <1e-300 | 95.7 EB05 77.2 · IC025 +5.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=61 · ♀ 100% (drug 68%) · 100% clinician | no trial arm names this drug |
| Retinitis | 322 | 119.1 105.5–134.5ROR 120.0 · χ² 30,248 / p <1e-300 | 95.5 EB05 87.1 · IC025 +6.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=322 · ♀ 100% (drug 68%) · 95% clinician | no trial arm names this drug |
| Pericarditis | 2,823 | 101.6 97.7–105.7ROR 108.9 · χ² 233,096 / p <1e-300 | 84.3 EB05 81.7 · IC025 +6.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 61.5 · ♀ 98% (drug 68%) · 92% clinician | no trial arm names this drug |
| C-reactive protein abnormal | 1,007 | 92.9 86.9–99.3ROR 95.1 · χ² 76,906 / p <1e-300 | 78.1 EB05 74.2 · IC025 +6.1 3/3 methods agree | Lab value / disease marker | serious n=1,007 · ♀ 100% (drug 68%) · 94% clinician | no trial arm names this drug |
| Synovitis | 2,734 | 88.9 85.5–92.5ROR 95.0 · χ² 201,314 / p <1e-300 | 75.4 EB05 73.1 · IC025 +6.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 57.1 · ♀ 100% (drug 68%) · 93% clinician | no trial arm names this drug |
| Breast cancer stage iii | 850 | 75.8 70.5–81.4ROR 77.3 · χ² 54,284 / p <1e-300 | 65.7 EB05 62.1 · IC025 +5.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=850 · ♀ 100% (drug 68%) · 92% clinician | no trial arm names this drug |
| Porphyria acute | 181 | 75.1 64.2–87.8ROR 75.4 · χ² 11,413 / p <1e-300 | 64.8 EB05 57.3 · IC025 +5.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=181 · ♀ 100% (drug 68%) · 100% clinician | no trial arm names this drug |
| Glossodynia (burning tongue/mouth pain) | 2,872 | 73.4 70.7–76.2ROR 78.7 · χ² 178,516 / p <1e-300 | 63.9 EB05 62.0 · IC025 +5.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 66.6 · ♀ 100% (drug 68%) · 90% clinician | no trial arm names this drug |
| Irritable bowel syndrome | 2,692 | 71.8 69.0–74.7ROR 76.6 · χ² 163,993 / p <1e-300 | 62.7 EB05 60.7 · IC025 +5.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 57.4 · ♀ 99% (drug 68%) · 93% clinician | no trial arm names this drug |
| Overlap syndrome | 83 | 68.1 54.1–85.6ROR 68.2 · χ² 4,758 / p <1e-300 | 59.1 EB05 49.2 · IC025 +5.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=83 · ♀ 100% (drug 68%) · 100% clinician | no trial arm names this drug |
Trial evidence (ClinicalTrials.gov)
No completed trial with posted adverse-event results was found on ClinicalTrials.gov for Cetiirizine (searched CETIIRIZINE).
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) | 5,734 | 3.7 3.6–3.8ROR 4.1 · χ² 11,621 / p <1e-300 | 3.7 EB05 3.6 · IC025 +1.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.5 | no trial arm names this drug |
| Drug ineffective (drug did not work) | 5,198 | 2.0 1.9–2.0ROR 2.1 · χ² 2,637 / p <1e-300 | 2.0 EB05 1.9 · IC025 +0.9 | Reporting / coding artifact | serious PRR 3.4 | no trial arm names this drug |
| Pain | 5,062 | 4.1 4.0–4.2ROR 4.6 · χ² 12,232 / p <1e-300 | 4.1 EB05 4.0 · IC025 +2.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.4 · ♀ 91% (drug 68%) | no trial arm names this drug |
| Rash | 5,005 | 5.8 5.7–6.0ROR 6.5 · χ² 20,083 / p <1e-300 | 5.7 EB05 5.6 · IC025 +2.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 8.4 · ♀ 89% (drug 68%) | no trial arm names this drug |
| Dyspnoea (shortness of breath) | 4,534 | 4.0 3.9–4.1ROR 4.4 · χ² 10,469 / p <1e-300 | 4.0 EB05 3.9 · IC025 +1.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 3.8 | no trial arm names this drug |
| Off label use (used outside approved label) | 4,490 | 2.6 2.5–2.7ROR 2.8 · χ² 4,526 / p <1e-300 | 2.6 EB05 2.5 · IC025 +1.3 3/3 methods agree | Reporting / coding artifact | serious PRR 3.1 | no trial arm names this drug |
| Pruritus (itching) | 4,422 | 5.9 5.7–6.1ROR 6.5 · χ² 18,039 / p <1e-300 | 5.8 EB05 5.7 · IC025 +2.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 9.2 | no trial arm names this drug |
| Arthralgia (joint pain) | 3,989 | 4.8 4.7–5.0ROR 5.2 · χ² 12,242 / p <1e-300 | 4.8 EB05 4.7 · IC025 +2.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.9 · ♀ 91% (drug 68%) | no trial arm names this drug |
| Pyrexia (fever) | 3,865 | 5.6 5.4–5.8ROR 6.1 · χ² 14,721 / p <1e-300 | 5.6 EB05 5.4 · IC025 +2.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.9 | no trial arm names this drug |
| Hypersensitivity (allergic reaction) | 3,715 | 10.2 9.9–10.5ROR 11.1 · χ² 30,344 / p <1e-300 | 10.0 EB05 9.7 · IC025 +3.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 13.1 · ♀ 95% (drug 68%) | no trial arm names this drug |
| Headache | 3,615 | 2.9 2.8–3.0ROR 3.1 · χ² 4,565 / p <1e-300 | 2.9 EB05 2.8 · IC025 +1.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 3.8 | no trial arm names this drug |
| Nausea | 3,603 | 2.3 2.2–2.4ROR 2.4 · χ² 2,678 / p <1e-300 | 2.3 EB05 2.2 · IC025 +1.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 2.7 | no trial arm names this drug |
| Joint swelling | 3,545 | 15.1 14.6–15.6ROR 16.4 · χ² 45,442 / p <1e-300 | 14.7 EB05 14.3 · IC025 +3.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 18.0 · ♀ 98% (drug 68%) | no trial arm names this drug |
| Swelling | 3,538 | 19.6 19.0–20.2ROR 21.3 · χ² 60,238 / p <1e-300 | 18.9 EB05 18.3 · IC025 +4.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 21.8 · ♀ 97% (drug 68%) | no trial arm names this drug |
| Abdominal discomfort | 3,473 | 10.5 10.2–10.9ROR 11.4 · χ² 29,613 / p <1e-300 | 10.3 EB05 10.1 · IC025 +3.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 16.2 · ♀ 94% (drug 68%) | no trial arm names this drug |
Unlabeled candidate signals
Every screened signal with n ≥ 20 was either labeled, an indication term, or an artifact pattern — no unlabeled candidate stood out in the top signals.
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 Cetiirizine?
In FDA FAERS, the most frequently co-reported reaction terms for Cetiirizine are fatigue, pain, rash, dyspnoea, pruritus, arthralgia. 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 Cetiirizine have an FDA boxed warning?
No. The FDA label retrieved for Cetiirizine has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Cetiirizine 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 fd8f495a-9940-363b-e053-6294a90a1097, effective 20251219; matched on
openfda.generic_name.exact:"CETIIRIZINE") - 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, 1,206 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 - ClinicalTrials.gov API v2 (query
CETIIRIZINE, results-bearing studies sorted by enrollment)
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.