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Drug · FAERS side-effect profile with label screen

Cetirizine side effects: what 77,111 FDA adverse event reports show

Cetirizine · Cetirizine Hydrochloride · 1,230 reaction terms · 817,943 drug–reaction co-reports · data 2026-09-14

Drug class

Not stated in label

Brand names

Cetirizine Hydrochloride

openFDA label

Who reports

77,111 reports · 76% serious · 8,614 with death outcome · 71% 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) 2Lab value / disease marker 7Not 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.
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, for the 300 most-reported drugs, adjusted for age band), and flags pairs whose reports are unusually skewed by sex or come mostly from consumers. Each row also shows the PRR against the other drugs of the same FDA class, which removes most confounding by the condition being treated, and a calibrated p-value: on validation, known non-causes average an ROR of about 2, so significance is judged against that empirical null (✓ = p < 0.05 after calibration). 1,190 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.

Show: hide coding/lab/outcome terms hide indication terms unlabeled only hide PRR-only

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Amyloid arthropathy	56	1,870.6 891.8–3,923.8ROR 1,872.0 · calibrated p 1e-16 ✓	217.4 EB05 173.6 · IC025 +5.8 3/3 methods agree	Not in label — unassessed	serious n=56 · ♀ 100% (drug 71%) · 100% clinician	not reported in cached trials
Anti-cyclic citrullinated peptide antibody positive	5,438	921.5 871.7–974.2ROR 991.3 · calibrated p 3e-17 ✓	207.8 EB05 203.2 · IC025 +7.6 3/3 methods agree	Lab value / disease marker	serious PRR 158.7 · ♀ 100% (drug 71%) · 93% clinician	not reported in cached trials
Swollen joint count increased	2,278	760.0 701.4–823.5ROR 783.1 · calibrated p 5e-16 ✓	198.1 EB05 191.4 · IC025 +7.5 3/3 methods agree	Lab value / disease marker	serious n=2,277 · ♀ 100% (drug 71%) · 96% clinician	not reported in cached trials
Anti-cyclic citrullinated peptide antibody	478	705.7 594.9–837.3ROR 710.1 · calibrated p 2e-15 ✓	193.1 EB05 179.0 · IC025 +7.2 3/3 methods agree	Lab value / disease marker	serious n=478 · ♀ 100% (drug 71%) · 95% clinician	not reported in cached trials
Cardiospasm	397	688.9 572.0–829.7ROR 692.5 · calibrated p 3e-15 ✓	191.5 EB05 176.2 · IC025 +7.1 3/3 methods agree	Not in label — unassessed	serious n=396	not reported in cached trials
Rheumatic fever	3,085	671.9 629.1–717.6ROR 699.8 · calibrated p 2e-15 ✓	191.7 EB05 186.1 · IC025 +7.5 3/3 methods agree	Not in label — unassessed	serious n=3,084 · ♀ 100% (drug 71%) · 95% clinician	not reported in cached trials
Pemphigus	8,559	616.3 593.4–640.1ROR 693.1 · calibrated p 2e-15 ✓	187.0 EB05 183.7 · IC025 +7.5 3/3 methods agree	Not in label — unassessed	serious PRR 142.8 · ♀ 100% (drug 71%)	not reported in cached trials
Duodenal ulcer perforation	4,993	592.2 563.8–622.1ROR 633.1 · calibrated p 5e-15 ✓	184.7 EB05 180.4 · IC025 +7.5 3/3 methods agree	Not in label — unassessed	serious PRR 140.5 · ♀ 100% (drug 71%) · 94% clinician	not reported in cached trials
Deep vein thrombosis postoperative	1,296	541.2 492.4–594.7ROR 550.4 · calibrated p 2e-14 ✓	179.1 EB05 171.1 · IC025 +7.3 3/3 methods agree	Not in label — unassessed	serious n=1,296 · ♀ 100% (drug 71%) · 94% clinician	not reported in cached trials
Lupus vulgaris	784	535.8 474.7–604.8ROR 541.3 · calibrated p 3e-14 ✓	178.2 EB05 168.0 · IC025 +7.2 3/3 methods agree	Not in label — unassessed	serious n=784 · ♀ 100% (drug 71%) · 96% clinician	not reported in cached trials
C-reactive protein	563	451.8 394.6–517.3ROR 455.1 · calibrated p 2e-13 ✓	167.6 EB05 156.3 · IC025 +7.1 3/3 methods agree	Lab value / disease marker	serious n=563 · ♀ 100% (drug 71%) · 96% clinician	not reported in cached trials
Hepatic enzyme	85	428.6 304.1–603.9ROR 429.1 · calibrated p 1e-12 ✓	159.4 EB05 132.9 · IC025 +6.0 3/3 methods agree	Not in label — unassessed	serious n=85 · ♀ 100% (drug 71%) · 100% clinician	not reported in cached trials
Rheumatoid factor positive	3,410	398.8 378.4–420.3ROR 417.2 · calibrated p 4e-13 ✓	160.5 EB05 156.0 · IC025 +7.2 3/3 methods agree	Lab value / disease marker	serious n=3,408 · ♀ 100% (drug 71%) · 94% clinician	not reported in cached trials
Immunisation	255	393.9 324.8–477.7ROR 395.2 · calibrated p 1e-12 ✓	157.9 EB05 142.3 · IC025 +6.7 3/3 methods agree	Not in label — unassessed	serious n=255	not reported in cached trials
Grip strength	135	383.8 295.0–499.3ROR 384.5 · calibrated p 2e-12 ✓	154.7 EB05 134.0 · IC025 +6.4 3/3 methods agree	Not in label — unassessed	serious n=135 · ♀ 100% (drug 71%) · 100% clinician	not reported in cached trials
Facet joint syndrome	1,804	368.6 343.4–395.6ROR 377.4 · calibrated p 1e-12 ✓	155.2 EB05 149.3 · IC025 +7.1 3/3 methods agree	Not in label — unassessed	serious n=1,804 · ♀ 100% (drug 71%) · 96% clinician	not reported in cached trials
Vaginal flatulence	171	348.8 277.9–437.9ROR 349.6 · calibrated p 4e-12 ✓	149.4 EB05 131.5 · IC025 +6.5 3/3 methods agree	Not in label — unassessed	serious n=171 · ♀ 100% (drug 71%)	not reported in cached trials
Swollen joint count	134	328.5 255.2–423.0ROR 329.1 · calibrated p 8e-12 ✓	144.9 EB05 125.4 · IC025 +6.3 3/3 methods agree	Not in label — unassessed	serious n=134 · ♀ 100% (drug 71%) · 100% clinician	not reported in cached trials
Hand deformity	7,034	319.7 309.1–330.8ROR 351.7 · calibrated p 2e-12 ✓	146.1 EB05 143.2 · IC025 +7.1 3/3 methods agree	Not in label — unassessed	serious PRR 120.9 · ♀ 100% (drug 71%) · 92% clinician	not reported in cached trials
Palmoplantar keratoderma	385	315.6 272.4–365.7ROR 317.2 · calibrated p 7e-12 ✓	144.2 EB05 132.5 · IC025 +6.8 3/3 methods agree	Not in label — unassessed	serious n=385	not reported in cached trials
Adjustment disorder with depressed mood	1,035	289.6 265.3–316.2ROR 293.5 · calibrated p 1e-11 ✓	139.2 EB05 132.2 · IC025 +6.9 3/3 methods agree	Not in label — unassessed	serious n=1,032 · ♀ 100% (drug 71%) · 96% clinician	not reported in cached trials
Helicobacter infection	4,932	256.9 247.2–267.0ROR 274.4 · calibrated p 2e-11 ✓	131.4 EB05 128.4 · IC025 +7.0 3/3 methods agree	Not in label — unassessed	serious PRR 105.7 · ♀ 100% (drug 71%) · 94% clinician	not reported in cached trials
Muscle injury	3,831	239.8 229.7–250.3ROR 252.2 · calibrated p 5e-11 ✓	126.8 EB05 123.4 · IC025 +6.9 3/3 methods agree	Labeled (related wording) related wording	serious PRR 104.5 · ♀ 100% (drug 71%) · 94% clinician	not reported in cached trials
Dislocation of vertebra	1,017	230.5 212.0–250.6ROR 233.6 · calibrated p 1e-10 ✓	123.9 EB05 117.7 · IC025 +6.8 3/3 methods agree	Not in label — unassessed	serious n=1,017 · ♀ 100% (drug 71%) · 95% clinician	not reported in cached trials
Sleep disorder due to general medical condition, insomnia type	2,758	204.9 195.1–215.2ROR 212.5 · calibrated p 2e-10 ✓	116.3 EB05 112.7 · IC025 +6.8 3/3 methods agree	Not in label — unassessed	serious n=2,752 · ♀ 100% (drug 71%) · 94% clinician	not reported in cached trials
Folliculitis	4,331	197.4 189.9–205.1ROR 209.1 · calibrated p 3e-10 ✓	113.9 EB05 111.1 · IC025 +6.8 3/3 methods agree	Not in label — unassessed	serious PRR 101.9 · ♀ 99% (drug 71%) · 94% clinician	not reported in cached trials
X-ray abnormal	737	192.1 174.8–211.2ROR 194.0 · calibrated p 5e-10 ✓	111.9 EB05 105.3 · IC025 +6.6 3/3 methods agree	Lab value / disease marker	serious n=737 · ♀ 100% (drug 71%) · 97% clinician	not reported in cached trials
Retinitis	669	182.6 165.6–201.4ROR 184.2 · calibrated p 9e-10 ✓	108.6 EB05 101.8 · IC025 +6.5 3/3 methods agree	Not in label — unassessed	serious n=669 · ♀ 100% (drug 71%) · 96% clinician	not reported in cached trials
Subcutaneous drug absorption impaired	218	182.1 153.3–216.2ROR 182.6 · calibrated p 1e-9 ✓	107.7 EB05 96.2 · IC025 +6.2 3/3 methods agree	Not in label — unassessed	serious n=216 · ♀ 100% (drug 71%) · 100% clinician	not reported in cached trials
Pericarditis	6,432	171.6 166.5–176.9ROR 187.1 · calibrated p 7e-10 ✓	104.9 EB05 102.7 · IC025 +6.7 3/3 methods agree	Not in label — unassessed	serious PRR 80.5 · ♀ 97% (drug 71%) · 91% clinician	not reported in cached trials
Anticipatory anxiety	99	157.5 122.9–201.8ROR 157.7 · calibrated p 5e-9 ✓	97.6 EB05 82.5 · IC025 +5.7 3/3 methods agree	Not in label — unassessed	serious n=99 · ♀ 100% (drug 71%)	not reported in cached trials
Glossodynia (burning tongue/mouth pain)	8,025	152.8 148.8–156.9ROR 170.4 · calibrated p 2e-9 ✓	97.5 EB05 95.8 · IC025 +6.6 3/3 methods agree	Labeled (related wording) related wording	serious PRR 107.2 · ♀ 100% (drug 71%) · 91% clinician	not reported in cached trials
Synovitis	6,152	141.0 136.8–145.3ROR 153.1 · calibrated p 4e-9 ✓	92.6 EB05 90.7 · IC025 +6.5 3/3 methods agree	Not in label — unassessed	serious PRR 73.8 · ♀ 100% (drug 71%) · 93% clinician	not reported in cached trials
Peripheral venous disease	1,356	140.1 131.3–149.6ROR 142.6 · calibrated p 7e-9 ✓	92.2 EB05 88.1 · IC025 +6.4 3/3 methods agree	Not in label — unassessed	serious n=1,354 · ♀ 100% (drug 71%) · 95% clinician	not reported in cached trials
Hypocholesterolaemia	90	112.4 87.9–143.8ROR 112.5 · calibrated p 7e-8 ✓	78.1 EB05 65.5 · IC025 +5.4 3/3 methods agree	Not in label — unassessed	serious n=90 · ♀ 100% (drug 71%) · 100% clinician	not reported in cached trials
Seronegative arthritis	328	112.4 98.8–127.8ROR 112.9 · calibrated p 5e-8 ✓	79.1 EB05 72.1 · IC025 +6.0 3/3 methods agree	Not in label — unassessed	serious n=328 · ♀ 100% (drug 71%) · 100% clinician	not reported in cached trials
C-reactive protein abnormal	1,662	95.3 90.1–100.7ROR 97.3 · calibrated p 1e-7 ✓	70.4 EB05 67.6 · IC025 +6.0 3/3 methods agree	Lab value / disease marker	serious n=1,662 · ♀ 100% (drug 71%) · 95% clinician	not reported in cached trials
Systemic lupus erythematosus	8,763	89.6 87.5–91.7ROR 100.9 · calibrated p 1e-7 ✓	67.3 EB05 66.1 · IC025 +6.0 3/3 methods agree	Not in label — unassessed	age-adj. PRR 68.1 · serious PRR 52.6 · ♀ 100% (drug 71%)	not reported in cached trials
Wound	6,786	87.8 85.5–90.2ROR 96.2 · calibrated p 1e-7 ✓	66.3 EB05 65.0 · IC025 +6.0 3/3 methods agree	Not in label — unassessed	age-adj. PRR 64.7 · serious PRR 60.0 · ♀ 99% (drug 71%) · 92% clinician	not reported in cached trials
Breast cancer stage iii	1,486	81.6 77.1–86.5ROR 83.2 · calibrated p 4e-7 ✓	62.7 EB05 60.1 · IC025 +5.9 3/3 methods agree	Not in label — unassessed	serious n=1,486 · ♀ 100% (drug 71%) · 94% clinician	not reported in cached trials

Clinical concept groups

MedDRA splits one clinical problem across several terms (e.g. "neutropenia", "neutrophil count decreased", "agranulocytosis"), which dilutes term-level signals. These rows count reports with any term in a concept group (an exact union, not a sum), compared with all other drugs. Groups are hand-built and listed in the methods.

Concept	Reports	PRR 95% CI	Reading
Liver injury	9,123	8.48.3–8.6	signal
Anaphylaxis / angioedema	2,506	5.55.3–5.7	signal
Interstitial lung disease	1,717	4.94.7–5.2	signal
Hyperglycaemia / diabetes	4,888	3.93.8–4.0	signal
Depression	3,347	3.33.2–3.4	signal
Serious infection	9,038	3.23.1–3.3	signal
Severe cutaneous reaction	661	2.42.2–2.6	signal
Pancreatitis	535	1.81.7–2.0	raised
Arrhythmia / qt	1,159	1.61.5–1.7	raised
Rhabdomyolysis / myopathy	471	1.61.4–1.7	raised
Hyponatraemia	462	1.61.4–1.7	raised
Tendon disorder	217	1.61.4–1.8	raised
Thrombocytopenia	1,250	1.51.5–1.6	raised
Fall / fracture	2,129	1.51.5–1.6	raised
Gi bleeding	977	1.51.4–1.5	raised
Opportunistic infection	645	1.31.2–1.4	raised

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)	13,508	2.8 2.8–2.9ROR 3.2 · calibrated p 0.567	2.8 EB05 2.7 · IC025 +1.5 3/3 methods agree	Reporting / coding artifact	age-adj. PRR 2.6 · serious PRR 5.0	not reported in cached trials
Fatigue (tiredness)	13,440	4.8 4.7–4.8ROR 5.6 · calibrated p 0.181	4.7 EB05 4.6 · IC025 +2.2 3/3 methods agree	Labeled adverse reaction exact term	age-adj. PRR 3.9 · serious PRR 6.2	NCT01916226: 1/170 (0.6%) on Cetirizine
Pain	12,536	5.6 5.5–5.7ROR 6.5 · calibrated p 0.120	5.5 EB05 5.5 · IC025 +2.4 3/3 methods agree	Labeled adverse reaction exact term	age-adj. PRR 4.8 · serious PRR 6.4 · ♀ 93% (drug 71%)	NCT01916226: 1/170 (0.6%) on Cetirizine
Rash	10,265	6.6 6.4–6.7ROR 7.4 · calibrated p 0.083	6.4 EB05 6.3 · IC025 +2.7 3/3 methods agree	Labeled adverse reaction exact term	age-adj. PRR 5.6 · serious PRR 10.0	not reported in cached trials
Off label use (used outside approved label)	9,972	3.1 3.1–3.2ROR 3.5 · calibrated p 0.493	3.1 EB05 3.1 · IC025 +1.6 3/3 methods agree	Reporting / coding artifact	age-adj. PRR 2.8 · serious PRR 3.9	not reported in cached trials
Abdominal discomfort	9,641	16.6 16.3–16.9ROR 18.8 · calibrated p 0.003 ✓	15.7 EB05 15.4 · IC025 +3.9 3/3 methods agree	Not in label — unassessed	age-adj. PRR 12.4 · serious PRR 26.1 · ♀ 96% (drug 71%)	not reported in cached trials
Alopecia (hair loss)	9,534	13.8 13.5–14.1ROR 15.6 · calibrated p 0.006 ✓	13.2 EB05 12.9 · IC025 +3.7 3/3 methods agree	Labeled adverse reaction exact term	age-adj. PRR 10.2 · serious PRR 21.0 · ♀ 97% (drug 71%)	not reported in cached trials
Rheumatoid arthritis	8,996	23.4 23.0–23.9ROR 26.4 · calibrated p 5e-4 ✓	21.6 EB05 21.3 · IC025 +4.4 3/3 methods agree	Not in label — unassessed	age-adj. PRR 17.0 · serious PRR 20.1 · ♀ 100% (drug 71%)	not reported in cached trials
Systemic lupus erythematosus	8,763	89.6 87.5–91.7ROR 100.9 · calibrated p 1e-7 ✓	67.3 EB05 66.1 · IC025 +6.0 3/3 methods agree	Not in label — unassessed	age-adj. PRR 68.1 · serious PRR 52.6 · ♀ 100% (drug 71%)	not reported in cached trials
Pemphigus	8,559	616.3 593.4–640.1ROR 693.1 · calibrated p 2e-15 ✓	187.0 EB05 183.7 · IC025 +7.5 3/3 methods agree	Not in label — unassessed	serious PRR 142.8 · ♀ 100% (drug 71%)	not reported in cached trials
Swelling	8,196	26.1 25.5–26.7ROR 29.1 · calibrated p 3e-4 ✓	23.9 EB05 23.4 · IC025 +4.5 3/3 methods agree	Not in label — unassessed	age-adj. PRR 19.7 · serious PRR 29.1 · ♀ 98% (drug 71%)	not reported in cached trials
Hypersensitivity (allergic reaction)	8,046	12.3 12.0–12.6ROR 13.6 · calibrated p 0.010 ✓	11.8 EB05 11.6 · IC025 +3.5 3/3 methods agree	Labeled adverse reaction exact term	age-adj. PRR 11.1 · serious PRR 16.3 · ♀ 95% (drug 71%)	not reported in cached trials
Glossodynia (burning tongue/mouth pain)	8,025	152.8 148.8–156.9ROR 170.4 · calibrated p 2e-9 ✓	97.5 EB05 95.8 · IC025 +6.6 3/3 methods agree	Labeled (related wording) related wording	serious PRR 107.2 · ♀ 100% (drug 71%) · 91% clinician	not reported in cached trials
Headache	7,893	3.5 3.4–3.5ROR 3.7 · calibrated p 0.430	3.4 EB05 3.4 · IC025 +1.7 3/3 methods agree	Labeled adverse reaction exact term	age-adj. PRR 3.1 · serious PRR 4.8	NCT00974571: 8/122 (6.6%) on Cetirizine; 36/613 (5.9%) control
Pruritus (itching)	7,886	5.8 5.7–5.9ROR 6.3 · calibrated p 0.131	5.7 EB05 5.6 · IC025 +2.5 3/3 methods agree	Likely indication confounding term in indications; also in warnings	age-adj. PRR 5.2 · serious PRR 9.2	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.

Amyloid arthropathy — n=56, PRR 1,870.6
Cardiospasm — n=397, PRR 688.9
Rheumatic fever — n=3,085, PRR 671.9
Pemphigus — n=8,559, PRR 616.3
Duodenal ulcer perforation — n=4,993, PRR 592.2
Deep vein thrombosis postoperative — n=1,296, PRR 541.2
Lupus vulgaris — n=784, PRR 535.8
Hepatic enzyme — n=85, PRR 428.6
Immunisation — n=255, PRR 393.9
Grip strength — n=135, PRR 383.8

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, abdominal discomfort, alopecia, rheumatoid arthritis. 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, field patient.drug.openfda.generic_name.exact, 1,230 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 2026-10-14. 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.