Drug · FAERS side-effect profile with label screen
Cetirizine side effects: what 30,106 FDA adverse event reports show
Drug class
Not stated in label
Brand names
Cetirizine Hydrochloride
openFDA label
Who reports
30,106 reports · 78% serious · 4,852 with death outcome · 79% 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) 2Likely indication confounding 1Lab value / disease marker 8Not in label — unassessed 29
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.
- 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. 1,184 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 |
|---|---|---|---|---|---|---|
| Swollen joint count increased | 1,972 | 1,222.4 1,136.6–1,314.6ROR 1,308.0 · χ² 864,932 / p <1e-300 | 438.2 EB05 422.2 · IC025 +8.6 3/3 methods agree | Lab value / disease marker | serious n=1,971 · ♀ 100% (drug 79%) · 95% clinician | not reported in cached trials |
| Monocyte chemotactic protein-1 increased | 22 | 1,161.2 585.0–2,304.9ROR 1,162.1 · χ² 9,046 / p <1e-300 | 314.0 EB05 218.5 · IC025 +4.6 3/3 methods agree | Lab value / disease marker | serious n=22 · ♀ 0% (drug 79%) | not reported in cached trials |
| Anti-cyclic citrullinated peptide antibody | 399 | 1,053.0 901.1–1,230.6ROR 1,067.2 · χ² 165,045 / p <1e-300 | 407.9 EB05 375.4 · IC025 +7.9 3/3 methods agree | Lab value / disease marker | serious n=399 · ♀ 100% (drug 79%) · 94% clinician | not reported in cached trials |
| Anti-cyclic citrullinated peptide antibody positive | 4,174 | 1,008.2 962.5–1,055.9ROR 1,170.2 · χ² 1,700,995 / p <1e-300 | 408.1 EB05 397.8 · IC025 +8.6 3/3 methods agree | Lab value / disease marker | serious PRR 302.3 · ♀ 100% (drug 79%) · 93% clinician | not reported in cached trials |
| Rheumatic fever | 2,557 | 999.8 941.8–1,061.3ROR 1,092.4 · χ² 1,038,194 / p <1e-300 | 406.3 EB05 393.2 · IC025 +8.5 3/3 methods agree | Not in label — unassessed | serious n=2,556 · ♀ 100% (drug 79%) · 95% clinician | not reported in cached trials |
| Hepatic enzyme | 81 | 975.1 695.0–1,368.2ROR 977.7 · χ² 32,156 / p <1e-300 | 368.2 EB05 305.7 · IC025 +6.5 3/3 methods agree | Not in label — unassessed | serious n=81 · ♀ 100% (drug 79%) · 100% clinician | not reported in cached trials |
| Pemphigus | 6,940 | 893.5 863.7–924.2ROR 1,160.8 · χ² 2,688,694 / p <1e-300 | 388.3 EB05 380.7 · IC025 +8.5 3/3 methods agree | Not in label — unassessed | serious PRR 287.3 · ♀ 100% (drug 79%) · 90% clinician | not reported in cached trials |
| Deep vein thrombosis postoperative | 1,094 | 891.6 815.5–974.7ROR 925.1 · χ² 422,904 / p <1e-300 | 385.7 EB05 366.9 · IC025 +8.3 3/3 methods agree | Not in label — unassessed | serious n=1,094 · ♀ 100% (drug 79%) · 95% clinician | not reported in cached trials |
| Lupus vulgaris | 654 | 861.4 768.1–965.9ROR 880.5 · χ² 248,835 / p <1e-300 | 378.2 EB05 354.5 · IC025 +8.1 3/3 methods agree | Not in label — unassessed | serious n=654 · ♀ 100% (drug 79%) · 95% clinician | not reported in cached trials |
| Rheumatoid factor positive | 3,007 | 767.6 729.6–807.6ROR 852.7 · χ² 1,086,577 / p <1e-300 | 362.0 EB05 351.3 · IC025 +8.4 3/3 methods agree | Lab value / disease marker | serious n=3,005 · ♀ 100% (drug 79%) · 94% clinician | not reported in cached trials |
| Grip strength | 115 | 692.2 534.4–896.7ROR 694.9 · χ² 39,170 / p <1e-300 | 326.3 EB05 279.3 · IC025 +6.8 3/3 methods agree | Not in label — unassessed | serious n=115 · ♀ 100% (drug 79%) · 100% clinician | not reported in cached trials |
| Swollen joint count | 122 | 691.9 538.2–889.4ROR 694.7 · χ² 41,565 / p <1e-300 | 327.3 EB05 281.4 · IC025 +6.9 3/3 methods agree | Not in label — unassessed | serious n=122 · ♀ 100% (drug 79%) · 100% clinician | not reported in cached trials |
| C-reactive protein | 449 | 689.3 605.0–785.3ROR 699.7 · χ² 153,609 / p <1e-300 | 339.4 EB05 313.8 · IC025 +7.8 3/3 methods agree | Lab value / disease marker | serious n=449 · ♀ 100% (drug 79%) · 95% clinician | not reported in cached trials |
| Duodenal ulcer perforation | 3,612 | 682.0 652.3–713.2ROR 774.9 · χ² 1,231,967 / p <1e-300 | 341.9 EB05 332.7 · IC025 +8.3 3/3 methods agree | Not in label — unassessed | serious PRR 252.1 · ♀ 100% (drug 79%) · 94% clinician | not reported in cached trials |
| Cardiospasm | 258 | 604.2 511.3–714.0ROR 609.4 · χ² 82,303 / p <1e-300 | 314.3 EB05 283.4 · IC025 +7.4 3/3 methods agree | Not in label — unassessed | serious n=258 · ♀ 54% (drug 79%) | not reported in cached trials |
| Adjustment disorder with depressed mood | 871 | 534.1 489.2–583.2ROR 550.0 · χ² 260,340 / p <1e-300 | 298.8 EB05 282.5 · IC025 +7.9 3/3 methods agree | Not in label — unassessed | serious n=870 · ♀ 100% (drug 79%) · 96% clinician | not reported in cached trials |
| Hand deformity | 5,567 | 520.0 503.2–537.4ROR 637.7 · χ² 1,641,274 / p <1e-300 | 296.0 EB05 289.5 · IC025 +8.1 3/3 methods agree | Not in label — unassessed | serious PRR 237.4 · ♀ 100% (drug 79%) · 93% clinician | not reported in cached trials |
| Immunisation | 173 | 465.5 383.9–564.5ROR 468.2 · χ² 47,502 / p <1e-300 | 269.5 EB05 237.4 · IC025 +7.0 3/3 methods agree | Not in label — unassessed | serious n=173 | not reported in cached trials |
| Facet joint syndrome | 1,253 | 462.5 430.9–496.4ROR 482.5 · χ² 344,465 / p <1e-300 | 275.5 EB05 263.0 · IC025 +7.9 3/3 methods agree | Not in label — unassessed | serious n=1,253 · ♀ 100% (drug 79%) · 95% clinician | not reported in cached trials |
| Dislocation of vertebra | 859 | 440.9 405.0–480.0ROR 453.8 · χ² 229,279 / p <1e-300 | 267.2 EB05 252.5 · IC025 +7.7 3/3 methods agree | Not in label — unassessed | serious n=859 · ♀ 100% (drug 79%) · 95% clinician | not reported in cached trials |
| X-ray abnormal | 666 | 417.0 378.9–458.8ROR 426.4 · χ² 171,666 / p <1e-300 | 257.8 EB05 241.8 · IC025 +7.6 3/3 methods agree | Lab value / disease marker | serious n=666 · ♀ 100% (drug 79%) · 97% clinician | not reported in cached trials |
| Anticipatory anxiety | 98 | 397.9 310.3–510.2ROR 399.2 · χ² 24,308 / p <1e-300 | 240.4 EB05 203.1 · IC025 +6.5 3/3 methods agree | Not in label — unassessed | serious n=98 · ♀ 100% (drug 79%) | not reported in cached trials |
| Palmoplantar keratoderma | 252 | 376.7 323.2–439.1ROR 379.9 · χ² 60,723 / p <1e-300 | 239.2 EB05 215.4 · IC025 +7.2 3/3 methods agree | Not in label — unassessed | serious n=252 · ♀ 55% (drug 79%) | not reported in cached trials |
| Helicobacter infection | 3,561 | 375.9 361.4–390.9ROR 426.1 · χ² 860,358 / p <1e-300 | 242.9 EB05 236.3 · IC025 +7.8 3/3 methods agree | Not in label — unassessed | serious PRR 189.3 · ♀ 100% (drug 79%) · 94% clinician | not reported in cached trials |
| Subcutaneous drug absorption impaired | 184 | 356.7 298.6–426.1ROR 358.9 · χ² 42,707 / p <1e-300 | 229.4 EB05 202.9 · IC025 +6.9 3/3 methods agree | Not in label — unassessed | serious n=184 · ♀ 100% (drug 79%) · 100% clinician | not reported in cached trials |
| Retinitis | 559 | 352.2 318.3–389.8ROR 358.9 · χ² 129,150 / p <1e-300 | 231.3 EB05 215.6 · IC025 +7.5 3/3 methods agree | Not in label — unassessed | serious n=559 · ♀ 100% (drug 79%) · 96% clinician | not reported in cached trials |
| Pericarditis | 4,875 | 289.1 280.1–298.3ROR 344.7 · χ² 985,266 / p <1e-300 | 203.5 EB05 198.8 · IC025 +7.6 3/3 methods agree | Not in label — unassessed | serious PRR 151.3 · 91% clinician | not reported in cached trials |
| Muscle injury | 2,389 | 287.0 274.0–300.6ROR 311.6 · χ² 480,058 / p <1e-300 | 202.3 EB05 195.6 · IC025 +7.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 161.7 · ♀ 100% (drug 79%) · 94% clinician | not reported in cached trials |
| Sleep disorder due to general medical condition, insomnia type | 1,864 | 284.8 270.2–300.2ROR 303.5 · χ² 372,448 / p <1e-300 | 201.1 EB05 193.6 · IC025 +7.5 3/3 methods agree | Not in label — unassessed | serious n=1,862 · ♀ 100% (drug 79%) · 94% clinician | not reported in cached trials |
| Sleep disorder due to general medical condition, hypersomnia type | 29 | 284.3 184.4–438.2ROR 284.6 · χ² 5,589 / p <1e-300 | 177.9 EB05 129.9 · IC025 +4.9 3/3 methods agree | Not in label — unassessed | serious n=29 · ♀ 100% (drug 79%) · 100% clinician | not reported in cached trials |
| Vaginal flatulence | 88 | 282.2 220.2–361.6ROR 283.0 · χ² 17,272 / p <1e-300 | 191.9 EB05 160.6 · IC025 +6.2 3/3 methods agree | Not in label — unassessed | serious n=88 · ♀ 100% (drug 79%) | not reported in cached trials |
| Glossodynia (burning tongue/mouth pain) | 6,419 | 281.5 274.1–289.2ROR 357.5 · χ² 1,273,503 / p <1e-300 | 199.8 EB05 195.7 · IC025 +7.6 3/3 methods agree | Labeled (related wording) related wording | serious PRR 213.2 · ♀ 100% (drug 79%) · 92% clinician | not reported in cached trials |
| Folliculitis | 2,741 | 252.3 241.9–263.2ROR 277.5 · χ² 501,743 / p <1e-300 | 184.5 EB05 178.8 · IC025 +7.4 3/3 methods agree | Not in label — unassessed | serious PRR 160.0 · ♀ 100% (drug 79%) · 95% clinician | not reported in cached trials |
| Synovitis | 4,750 | 249.5 241.9–257.4ROR 296.1 · χ² 862,807 / p <1e-300 | 183.1 EB05 178.8 · IC025 +7.4 3/3 methods agree | Not in label — unassessed | serious PRR 141.3 · ♀ 100% (drug 79%) · 93% clinician | not reported in cached trials |
| Tender joint count | 21 | 228.7 139.6–374.8ROR 228.9 · χ² 3,402 / p <1e-300 | 148.8 EB05 102.7 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious n=21 · ♀ 100% (drug 79%) | not reported in cached trials |
| Peripheral venous disease | 985 | 228.6 212.9–245.4ROR 236.3 · χ² 167,275 / p <1e-300 | 171.1 EB05 162.4 · IC025 +7.2 3/3 methods agree | Not in label — unassessed | serious n=984 · ♀ 100% (drug 79%) · 95% clinician | not reported in cached trials |
| Seronegative arthritis | 268 | 218.9 190.9–251.1ROR 220.9 · χ² 43,913 / p <1e-300 | 164.3 EB05 148.4 · IC025 +6.8 3/3 methods agree | Not in label — unassessed | serious n=268 · ♀ 100% (drug 79%) · 94% clinician | not reported in cached trials |
| Urticaria thermal | 34 | 216.0 147.0–317.6ROR 216.3 · χ² 5,372 / p <1e-300 | 150.8 EB05 112.8 · IC025 +5.0 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=34 · ♀ 100% (drug 79%) | not reported in cached trials |
| Alpha tumour necrosis factor increased | 22 | 212.6 131.8–343.0ROR 212.8 · χ² 3,378 / p <1e-300 | 142.7 EB05 99.3 · IC025 +4.4 3/3 methods agree | Lab value / disease marker | serious n=22 · ♀ 0% (drug 79%) | not reported in cached trials |
| Bronchial neoplasm | 30 | 196.1 130.7–294.1ROR 196.2 · χ² 4,377 / p <1e-300 | 139.3 EB05 102.3 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious n=30 · ♀ 100% (drug 79%) | 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) | 9,400 | 5.0 4.9–5.1ROR 6.8 · χ² 31,865 / p <1e-300 | 5.0 EB05 4.9 · IC025 +2.3 3/3 methods agree | Reporting / coding artifact | serious PRR 8.9 | not reported in cached trials |
| Pain | 8,846 | 10.1 10.0–10.3ROR 13.9 · χ² 74,026 / p <1e-300 | 10.0 EB05 9.8 · IC025 +3.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 11.5 | NCT01916226: 1/170 (0.6%) on Cetirizine |
| Fatigue (tiredness) | 8,749 | 7.9 7.8–8.1ROR 10.8 · χ² 54,316 / p <1e-300 | 7.8 EB05 7.7 · IC025 +2.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 10.6 | NCT01916226: 1/170 (0.6%) on Cetirizine |
| Alopecia (hair loss) | 7,448 | 27.4 26.8–27.9ROR 36.0 · χ² 183,664 / p <1e-300 | 26.4 EB05 25.9 · IC025 +4.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 41.3 | not reported in cached trials |
| Rheumatoid arthritis | 7,360 | 48.5 47.5–49.5ROR 63.8 · χ² 321,196 / p <1e-300 | 45.3 EB05 44.5 · IC025 +5.5 3/3 methods agree | Not in label — unassessed | serious PRR 40.8 · ♀ 100% (drug 79%) | not reported in cached trials |
| Abdominal discomfort | 7,329 | 31.9 31.3–32.6ROR 41.8 · χ² 211,316 / p <1e-300 | 30.5 EB05 29.9 · IC025 +4.9 3/3 methods agree | Not in label — unassessed | serious PRR 50.1 | not reported in cached trials |
| Systemic lupus erythematosus | 7,067 | 174.2 170.1–178.3ROR 227.3 · χ² 971,874 / p <1e-300 | 139.1 EB05 136.4 · IC025 +7.1 3/3 methods agree | Not in label — unassessed | serious PRR 105.2 · ♀ 100% (drug 79%) · 90% clinician | not reported in cached trials |
| Pemphigus | 6,940 | 893.5 863.7–924.2ROR 1,160.8 · χ² 2,688,694 / p <1e-300 | 388.3 EB05 380.7 · IC025 +8.5 3/3 methods agree | Not in label — unassessed | serious PRR 287.3 · ♀ 100% (drug 79%) · 90% clinician | not reported in cached trials |
| Off label use (used outside approved label) | 6,610 | 5.3 5.2–5.5ROR 6.6 · χ² 24,113 / p <1e-300 | 5.3 EB05 5.2 · IC025 +2.4 3/3 methods agree | Reporting / coding artifact | serious PRR 6.6 | not reported in cached trials |
| Rash | 6,536 | 10.6 10.4–10.9ROR 13.3 · χ² 57,419 / p <1e-300 | 10.5 EB05 10.3 · IC025 +3.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 16.8 | not reported in cached trials |
| Glossodynia (burning tongue/mouth pain) | 6,419 | 281.5 274.1–289.2ROR 357.5 · χ² 1,273,503 / p <1e-300 | 199.8 EB05 195.7 · IC025 +7.6 3/3 methods agree | Labeled (related wording) related wording | serious PRR 213.2 · ♀ 100% (drug 79%) · 92% clinician | not reported in cached trials |
| Swelling | 5,990 | 47.7 46.6–48.8ROR 59.3 · χ² 257,180 / p <1e-300 | 44.7 EB05 43.7 · IC025 +5.4 3/3 methods agree | Not in label — unassessed | serious PRR 53.2 · 91% clinician | not reported in cached trials |
| Hypersensitivity (allergic reaction) | 5,658 | 21.9 21.4–22.4ROR 26.7 · χ² 110,335 / p <1e-300 | 21.3 EB05 20.8 · IC025 +4.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 29.0 | not reported in cached trials |
| Hand deformity | 5,567 | 520.0 503.2–537.4ROR 637.7 · χ² 1,641,274 / p <1e-300 | 296.0 EB05 289.5 · IC025 +8.1 3/3 methods agree | Not in label — unassessed | serious PRR 237.4 · ♀ 100% (drug 79%) · 93% clinician | not reported in cached trials |
| Infusion related reaction (reaction during infusion) | 5,494 | 63.2 61.6–64.8ROR 77.0 · χ² 308,670 / p <1e-300 | 57.9 EB05 56.6 · IC025 +5.8 3/3 methods agree | Not in label — unassessed | serious PRR 53.6 · ♀ 99% (drug 79%) · 92% clinician | 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.
- Rheumatic fever — n=2,557, PRR 999.8
- Hepatic enzyme — n=81, PRR 975.1
- Pemphigus — n=6,940, PRR 893.5
- Deep vein thrombosis postoperative — n=1,094, PRR 891.6
- Lupus vulgaris — n=654, PRR 861.4
- Grip strength — n=115, PRR 692.2
- Swollen joint count — n=122, PRR 691.9
- Duodenal ulcer perforation — n=3,612, PRR 682.0
- Cardiospasm — n=258, PRR 604.2
- Adjustment disorder with depressed mood — n=871, PRR 534.1
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 pain, fatigue, alopecia, rheumatoid arthritis, abdominal discomfort, systemic lupus erythematosus. 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, 1,224 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.