Drug · FAERS side-effect profile with label screen
Cetirizine side effects: what 163,560 FDA adverse event reports show
Drug class
Not stated in label
Brand names
Cetirizine Hydrochloride
openFDA label
Who reports
163,560 reports · 55% serious · 10,788 with death outcome · 72% 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
Cetirizine is a member of the class of piperazines that is piperazine in which the hydrogens attached to nitrogen are replaced by a (4-chlorophenyl)(phenyl)methyl and a 2-(carboxymethoxy)ethyl group respectively.
PubChem CID 2678 (ChEBI)
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) 2Reporting / coding artifact 1Lab value / disease marker 7Not in label — unassessed 30
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.
- 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.
- 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. 1,152 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 |
|---|---|---|---|---|---|---|
| Anti-cyclic citrullinated peptide antibody positive | 5,442 | 433.3 409.7–458.2ROR 448.1 · χ² 526,347 / p <1e-300 | 97.9 EB05 95.7 · IC025 +6.6 3/3 methods agree | Lab value / disease marker | serious PRR 102.8 · ♀ 100% (drug 72%) · 93% clinician | not reported in cached trials |
| Swollen joint count increased | 2,279 | 356.8 329.2–386.6ROR 361.8 · χ² 210,008 / p <1e-300 | 93.4 EB05 90.2 · IC025 +6.4 3/3 methods agree | Lab value / disease marker | serious n=2,278 · ♀ 100% (drug 72%) · 96% clinician | not reported in cached trials |
| Anti-cyclic citrullinated peptide antibody | 477 | 328.2 276.7–389.3ROR 329.2 · χ² 42,886 / p <1e-300 | 91.0 EB05 84.4 · IC025 +6.2 3/3 methods agree | Lab value / disease marker | serious n=477 · ♀ 100% (drug 72%) · 100% clinician | not reported in cached trials |
| Cardiospasm | 397 | 322.8 268.0–388.8ROR 323.6 · χ² 35,511 / p <1e-300 | 90.6 EB05 83.3 · IC025 +6.2 3/3 methods agree | Not in label — unassessed | serious n=396 | not reported in cached trials |
| Rheumatic fever | 3,089 | 316.3 296.1–337.9ROR 322.4 · χ² 275,346 / p <1e-300 | 90.4 EB05 87.7 · IC025 +6.4 3/3 methods agree | Not in label — unassessed | serious n=3,088 · ♀ 100% (drug 72%) · 95% clinician | not reported in cached trials |
| Pemphigus | 8,560 | 289.0 278.1–300.2ROR 304.8 · χ² 743,055 / p <1e-300 | 88.0 EB05 86.5 · IC025 +6.4 3/3 methods agree | Not in label — unassessed | serious PRR 92.4 · ♀ 100% (drug 72%) | not reported in cached trials |
| Duodenal ulcer perforation | 4,996 | 278.1 264.6–292.2ROR 286.8 · χ² 428,356 / p <1e-300 | 87.0 EB05 85.0 · IC025 +6.4 3/3 methods agree | Not in label — unassessed | serious PRR 91.0 · ♀ 100% (drug 72%) · 94% clinician | not reported in cached trials |
| Deep vein thrombosis postoperative | 1,299 | 255.4 232.3–280.7ROR 257.4 · χ² 108,226 / p <1e-300 | 84.6 EB05 80.8 · IC025 +6.3 3/3 methods agree | Not in label — unassessed | serious n=1,299 · ♀ 100% (drug 72%) · 94% clinician | not reported in cached trials |
| Lupus vulgaris | 785 | 252.1 223.3–284.6ROR 253.3 · χ² 65,078 / p <1e-300 | 84.2 EB05 79.3 · IC025 +6.2 3/3 methods agree | Not in label — unassessed | serious n=785 · ♀ 100% (drug 72%) · 100% clinician | not reported in cached trials |
| C-reactive protein | 564 | 212.7 185.8–243.6ROR 213.5 · χ² 43,966 / p <1e-300 | 79.3 EB05 73.9 · IC025 +6.1 3/3 methods agree | Lab value / disease marker | serious n=564 · ♀ 100% (drug 72%) · 100% clinician | not reported in cached trials |
| Immunisation | 257 | 188.2 155.1–228.4ROR 188.5 · χ² 19,046 / p <1e-300 | 75.4 EB05 68.0 · IC025 +5.8 3/3 methods agree | Not in label — unassessed | serious n=255 | not reported in cached trials |
| Rheumatoid factor positive | 3,411 | 187.0 177.4–197.2ROR 191.0 · χ² 253,120 / p <1e-300 | 75.6 EB05 73.5 · IC025 +6.2 3/3 methods agree | Lab value / disease marker | serious n=3,409 · ♀ 100% (drug 72%) · 94% clinician | not reported in cached trials |
| Grip strength | 135 | 179.9 138.2–234.0ROR 180.0 · χ² 9,783 / p <1e-300 | 73.7 EB05 63.8 · IC025 +5.6 3/3 methods agree | Not in label — unassessed | serious n=135 · ♀ 100% (drug 72%) · 100% clinician | not reported in cached trials |
| Facet joint syndrome | 1,826 | 177.8 165.6–190.9ROR 179.8 · χ² 132,621 / p <1e-300 | 74.0 EB05 71.2 · IC025 +6.1 3/3 methods agree | Not in label — unassessed | serious n=1,826 · ♀ 100% (drug 72%) · 95% clinician | not reported in cached trials |
| Vaginal flatulence | 171 | 163.5 130.2–205.2ROR 163.6 · χ² 11,907 / p <1e-300 | 70.9 EB05 62.4 · IC025 +5.6 3/3 methods agree | Not in label — unassessed | serious n=171 · ♀ 100% (drug 72%) · 100% clinician | not reported in cached trials |
| Swollen joint count | 134 | 154.0 119.6–198.2ROR 154.1 · χ² 9,065 / p <1e-300 | 69.0 EB05 59.7 · IC025 +5.5 3/3 methods agree | Not in label — unassessed | serious n=134 · ♀ 100% (drug 72%) · 100% clinician | not reported in cached trials |
| Hand deformity | 7,039 | 150.1 145.0–155.3ROR 156.8 · χ² 474,372 / p <1e-300 | 68.8 EB05 67.5 · IC025 +6.1 3/3 methods agree | Not in label — unassessed | serious PRR 78.3 · ♀ 100% (drug 72%) · 92% clinician | not reported in cached trials |
| Palmoplantar keratoderma | 384 | 147.1 126.9–170.4ROR 147.4 · χ² 25,554 / p <1e-300 | 68.0 EB05 62.4 · IC025 +5.8 3/3 methods agree | Not in label — unassessed | serious n=384 | not reported in cached trials |
| Adjustment disorder with depressed mood | 1,046 | 138.8 127.1–151.5ROR 139.7 · χ² 67,807 / p <1e-300 | 66.3 EB05 63.0 · IC025 +5.9 3/3 methods agree | Not in label — unassessed | serious n=1,043 · ♀ 100% (drug 72%) · 96% clinician | not reported in cached trials |
| Helicobacter infection | 4,960 | 121.7 117.1–126.6ROR 125.5 · χ² 301,273 / p <1e-300 | 62.2 EB05 60.8 · IC025 +5.9 3/3 methods agree | Not in label — unassessed | serious PRR 68.8 · ♀ 100% (drug 72%) · 93% clinician | not reported in cached trials |
| Muscle injury | 3,851 | 113.5 108.7–118.5ROR 116.2 · χ² 225,267 / p <1e-300 | 60.0 EB05 58.4 · IC025 +5.8 3/3 methods agree | Labeled (related wording) related wording | serious PRR 68.0 · ♀ 100% (drug 72%) · 94% clinician | not reported in cached trials |
| Dislocation of vertebra | 1,024 | 109.4 100.6–119.0ROR 110.1 · χ² 58,658 / p <1e-300 | 58.8 EB05 55.8 · IC025 +5.7 3/3 methods agree | Not in label — unassessed | serious n=1,024 · ♀ 100% (drug 72%) · 95% clinician | not reported in cached trials |
| Sleep disorder due to general medical condition, insomnia type | 2,782 | 97.5 92.8–102.4ROR 99.2 · χ² 149,397 / p <1e-300 | 55.2 EB05 53.5 · IC025 +5.7 3/3 methods agree | Not in label — unassessed | serious n=2,763 · ♀ 100% (drug 72%) · 94% clinician | not reported in cached trials |
| Folliculitis | 4,362 | 93.7 90.1–97.4ROR 96.2 · χ² 228,821 / p <1e-300 | 54.0 EB05 52.7 · IC025 +5.7 3/3 methods agree | Not in label — unassessed | serious PRR 66.3 · ♀ 99% (drug 72%) · 94% clinician | not reported in cached trials |
| X-ray abnormal | 742 | 91.1 82.9–100.1ROR 91.5 · χ² 38,228 / p <1e-300 | 53.1 EB05 50.0 · IC025 +5.6 3/3 methods agree | Lab value / disease marker | serious n=742 · ♀ 100% (drug 72%) · 100% clinician | not reported in cached trials |
| Subcutaneous drug absorption impaired | 221 | 87.3 73.5–103.7ROR 87.4 · χ² 11,059 / p <1e-300 | 51.6 EB05 46.2 · IC025 +5.3 3/3 methods agree | Not in label — unassessed | serious n=220 · ♀ 100% (drug 72%) · 100% clinician | not reported in cached trials |
| Retinitis | 671 | 86.0 78.0–94.9ROR 86.4 · χ² 33,375 / p <1e-300 | 51.3 EB05 48.1 · IC025 +5.5 3/3 methods agree | Not in label — unassessed | serious n=671 · ♀ 100% (drug 72%) · 100% clinician | not reported in cached trials |
| Pericarditis | 6,456 | 80.9 78.5–83.5ROR 84.2 · χ² 309,770 / p <1e-300 | 49.5 EB05 48.5 · IC025 +5.6 3/3 methods agree | Not in label — unassessed | serious PRR 52.3 · ♀ 97% (drug 72%) · 91% clinician | not reported in cached trials |
| Glossodynia (burning tongue/mouth pain) | 8,134 | 73.1 71.2–75.1ROR 76.9 · χ² 365,676 / p <1e-300 | 46.5 EB05 45.7 · IC025 +5.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 69.7 · ♀ 100% (drug 72%) · 90% clinician | not reported in cached trials |
| Peripheral venous disease | 1,376 | 67.2 62.9–71.7ROR 67.7 · χ² 58,341 / p <1e-300 | 44.0 EB05 42.1 · IC025 +5.4 3/3 methods agree | Not in label — unassessed | serious n=1,373 · ♀ 100% (drug 72%) · 94% clinician | not reported in cached trials |
| Synovitis | 6,167 | 66.3 64.3–68.4ROR 68.9 · χ² 259,576 / p <1e-300 | 43.7 EB05 42.8 · IC025 +5.4 3/3 methods agree | Not in label — unassessed | serious PRR 47.8 · ♀ 100% (drug 72%) · 93% clinician | not reported in cached trials |
| Seronegative arthritis | 329 | 52.9 46.5–60.2ROR 53.0 · χ² 11,740 / p <1e-300 | 37.4 EB05 34.1 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious n=329 · ♀ 100% (drug 72%) · 100% clinician | not reported in cached trials |
| C-reactive protein abnormal | 1,666 | 44.8 42.4–47.4ROR 45.2 · χ² 52,521 / p <1e-300 | 33.2 EB05 31.9 · IC025 +5.0 3/3 methods agree | Lab value / disease marker | serious n=1,666 · ♀ 100% (drug 72%) · 95% clinician | not reported in cached trials |
| Systemic lupus erythematosus | 8,891 | 42.8 41.8–43.8ROR 45.2 · χ² 270,890 / p <1e-300 | 32.1 EB05 31.6 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious PRR 34.5 · ♀ 100% (drug 72%) | not reported in cached trials |
| Wound | 6,913 | 42.2 41.1–43.3ROR 44.0 · χ² 208,141 / p <1e-300 | 31.8 EB05 31.2 · IC025 +4.9 3/3 methods agree | Not in label — unassessed | serious PRR 39.4 · ♀ 99% (drug 72%) · 91% clinician | not reported in cached trials |
| Breast cancer stage iii | 1,490 | 38.4 36.2–40.7ROR 38.7 · χ² 41,510 / p <1e-300 | 29.6 EB05 28.4 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious n=1,490 · ♀ 100% (drug 72%) · 94% clinician | not reported in cached trials |
| Contraindicated product administered | 6,687 | 36.3 35.3–37.3ROR 37.8 · χ² 178,122 / p <1e-300 | 28.4 EB05 27.8 · IC025 +4.8 3/3 methods agree | Reporting / coding artifact | serious PRR 36.7 · ♀ 99% (drug 72%) · 90% clinician | not reported in cached trials |
| Temperature regulation disorder | 459 | 33.9 30.5–37.5ROR 33.9 · χ² 11,495 / p <1e-300 | 26.8 EB05 24.8 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious n=456 · ♀ 100% (drug 72%) | not reported in cached trials |
| Irritable bowel syndrome | 4,426 | 33.3 32.2–34.4ROR 34.2 · χ² 109,538 / p <1e-300 | 26.5 EB05 25.8 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious PRR 34.8 · ♀ 98% (drug 72%) · 91% clinician | not reported in cached trials |
| Lip dry | 1,854 | 33.2 31.6–35.0ROR 33.6 · χ² 45,781 / p <1e-300 | 26.5 EB05 25.5 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious n=1,807 · ♀ 99% (drug 72%) · 94% clinician | not reported in cached trials |
Trial evidence (ClinicalTrials.gov)
✓ Trial adverse-event data found on ClinicalTrials.gov
Largest completed trials with posted results that list Cetirizine as a study intervention. The right-hand column of the signal table shows whether each FAERS term was also recorded in these trials, with a real denominator (0 of 40 signal terms matched).
- NCT00974571 — Montelukast in Perennial Allergic Rhinitis - 2001-2002 Study (0476-246) (N=1365, PHASE3; 5 AE terms posted; arms: Montelukast 10 mg; Cetirizine 10 mg; Placebo)
- NCT01916226 — A Comparator Study of Fluticasone Propionate Nasal Spray Verses (vs) Cetirizine in the Treatment of Seasonal A (N=682, PHASE4; 34 AE terms posted; arms: FPNS 200 μg; Cetirizine 10 mg; FPNS Matching Placebo; Cetirizine Matching Placebo)
Caveats: trial populations, doses and follow-up differ from the reporting population; AE terms are sponsor-coded and matched here by wording; absence from a trial list means the term was not reported above the sponsor's frequency threshold, not that it cannot occur.
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 |
|---|---|---|---|---|---|---|
| Drug ineffective (drug did not work) | 21,703 | 2.1 2.1–2.2ROR 2.3 · χ² 13,604 / p <1e-300 | 2.1 EB05 2.1 · IC025 +1.1 3/3 methods agree | Reporting / coding artifact | serious PRR 3.6 | not reported in cached trials |
| Fatigue (tiredness) | 18,862 | 3.2 3.1–3.2ROR 3.4 · χ² 28,192 / p <1e-300 | 3.1 EB05 3.1 · IC025 +1.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.8 | NCT01916226: 1/170 (0.6%) on Cetirizine |
| Pain | 15,934 | 3.4 3.3–3.4ROR 3.6 · χ² 26,716 / p <1e-300 | 3.3 EB05 3.3 · IC025 +1.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.9 | NCT01916226: 1/170 (0.6%) on Cetirizine |
| Off label use (used outside approved label) | 14,268 | 2.1 2.1–2.2ROR 2.2 · χ² 8,680 / p <1e-300 | 2.1 EB05 2.1 · IC025 +1.0 3/3 methods agree | Reporting / coding artifact | serious PRR 2.8 | not reported in cached trials |
| Rash | 13,441 | 4.1 4.0–4.1ROR 4.3 · χ² 30,676 / p <1e-300 | 4.0 EB05 3.9 · IC025 +2.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.3 | not reported in cached trials |
| Headache | 12,655 | 2.6 2.6–2.7ROR 2.8 · χ² 12,783 / p <1e-300 | 2.6 EB05 2.5 · IC025 +1.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.1 | NCT00974571: 8/122 (6.6%) on Cetirizine; 36/613 (5.9%) control |
| Pruritus (itching) | 12,549 | 4.4 4.3–4.4ROR 4.6 · χ² 31,981 / p <1e-300 | 4.2 EB05 4.2 · IC025 +2.1 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 7.2 | not reported in cached trials |
| Nausea | 11,891 | 1.9 1.9–2.0ROR 2.0 · χ² 5,563 / p <1e-300 | 1.9 EB05 1.9 · IC025 +0.9 | Labeled adverse reaction exact term | serious PRR 2.8 | not reported in cached trials |
| Dyspnoea (shortness of breath) | 11,184 | 2.6 2.5–2.6ROR 2.7 · χ² 10,714 / p <1e-300 | 2.5 EB05 2.5 · IC025 +1.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.1 | not reported in cached trials |
| Abdominal discomfort | 10,730 | 8.7 8.5–8.9ROR 9.3 · χ² 69,041 / p <1e-300 | 8.2 EB05 8.1 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 17.7 · ♀ 94% (drug 72%) | not reported in cached trials |
| Alopecia (hair loss) | 10,612 | 7.2 7.1–7.4ROR 7.7 · χ² 54,456 / p <1e-300 | 6.9 EB05 6.8 · IC025 +2.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 14.3 · ♀ 97% (drug 72%) | not reported in cached trials |
| Arthralgia (joint pain) | 10,416 | 3.3 3.2–3.3ROR 3.4 · χ² 16,350 / p <1e-300 | 3.2 EB05 3.2 · IC025 +1.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.2 | NCT01916226: 1/170 (0.6%) on Cetirizine |
| Diarrhoea (diarrhea) | 9,944 | 2.0 2.0–2.0ROR 2.1 · χ² 4,997 / p <1e-300 | 2.0 EB05 1.9 · IC025 +1.0 | Labeled adverse reaction exact term | serious PRR 2.7 | not reported in cached trials |
| Hypersensitivity (allergic reaction) | 9,913 | 7.2 7.0–7.3ROR 7.6 · χ² 50,274 / p <1e-300 | 6.8 EB05 6.7 · IC025 +2.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 11.7 · ♀ 92% (drug 72%) | not reported in cached trials |
| Rheumatoid arthritis | 9,376 | 11.5 11.3–11.7ROR 12.1 · χ² 82,670 / p <1e-300 | 10.6 EB05 10.4 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 13.4 · ♀ 99% (drug 72%) | not reported in cached trials |
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.
- Cardiospasm — n=397, PRR 322.8
- Rheumatic fever — n=3,089, PRR 316.3
- Pemphigus — n=8,560, PRR 289.0
- Duodenal ulcer perforation — n=4,996, PRR 278.1
- Deep vein thrombosis postoperative — n=1,299, PRR 255.4
- Lupus vulgaris — n=785, PRR 252.1
- Immunisation — n=257, PRR 188.2
- Grip strength — n=135, PRR 179.9
- Facet joint syndrome — n=1,826, PRR 177.8
- Vaginal flatulence — n=171, PRR 163.5
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, pain, rash, headache, pruritus, nausea. 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" AND openfda.product_type:"HUMAN PRESCRIPTION DRUG") - PubChem CID 2678 description (ChEBI)
- 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, 1,192 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
CETIRIZINE, 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.