Drug · FAERS side-effect profile with label screen
Cetirizine and Pseudoephedrine side effects: what 640 FDA adverse event reports show
Drug class
Not stated in label
Label matched
Cetirizine (Cetirizine Hydrochloride)
closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match
Who reports
640 reports · 95% serious · 261 with death outcome · 96% 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) 3Reporting / coding artifact 4Lab value / disease marker 1Not in label — unassessed 32
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. 94 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 |
|---|---|---|---|---|---|---|
| Pemphigus | 345 | 935.4 868.8–1,007.1ROR 2,028.1 · χ² 312,237 / p <1e-300 | 865.1 EB05 791.2 · IC025 +8.4 3/3 methods agree | Not in label — unassessed | serious PRR 554.4 | no trial data cached |
| Hand deformity | 305 | 782.1 719.8–849.9ROR 1,493.3 · χ² 231,702 / p <1e-300 | 728.5 EB05 662.4 · IC025 +8.2 3/3 methods agree | Not in label — unassessed | serious PRR 505.0 | no trial data cached |
| Helicobacter infection | 192 | 628.9 557.8–709.1ROR 898.1 · χ² 117,517 / p <1e-300 | 581.0 EB05 515.2 · IC025 +7.7 3/3 methods agree | Not in label — unassessed | serious PRR 396.4 | no trial data cached |
| Pericarditis | 289 | 578.3 530.2–630.7ROR 1,053.6 · χ² 163,180 / p <1e-300 | 547.4 EB05 496.5 · IC025 +8.0 3/3 methods agree | Not in label — unassessed | serious PRR 348.2 | no trial data cached |
| Synovitis | 257 | 473.3 430.1–520.9ROR 790.3 · χ² 119,020 / p <1e-300 | 450.8 EB05 406.4 · IC025 +7.7 3/3 methods agree | Not in label — unassessed | serious PRR 297.1 | no trial data cached |
| Glossodynia (burning tongue/mouth pain) | 309 | 459.2 423.4–498.1ROR 887.0 · χ² 139,000 / p <1e-300 | 440.4 EB05 400.7 · IC025 +7.8 3/3 methods agree | Labeled (related wording) related wording | serious PRR 398.7 | no trial data cached |
| Folliculitis | 121 | 388.3 330.4–456.5ROR 478.6 · χ² 45,833 / p <1e-300 | 361.7 EB05 310.8 · IC025 +6.9 3/3 methods agree | Not in label — unassessed | serious PRR 274.2 | no trial data cached |
| Wound | 295 | 351.4 322.9–382.4ROR 651.0 · χ² 101,747 / p <1e-300 | 339.9 EB05 308.6 · IC025 +7.6 3/3 methods agree | Not in label — unassessed | serious PRR 251.7 | no trial data cached |
| Autoimmune disorder | 94 | 324.9 269.3–392.1ROR 380.7 · χ² 29,748 / p <1e-300 | 301.9 EB05 254.1 · IC025 +6.6 3/3 methods agree | Not in label — unassessed | serious PRR 209.2 · 90% clinician | no trial data cached |
| Systemic lupus erythematosus | 335 | 313.2 290.7–337.5ROR 656.2 · χ² 103,132 / p <1e-300 | 304.8 EB05 278.4 · IC025 +7.5 3/3 methods agree | Not in label — unassessed | serious PRR 193.6 | no trial data cached |
| Hypercholesterolaemia | 73 | 251.9 202.8–312.9ROR 284.2 · χ² 17,861 / p <1e-300 | 234.6 EB05 192.8 · IC025 +6.1 3/3 methods agree | Not in label — unassessed | serious PRR 161.5 · 90% clinician | no trial data cached |
| Wound infection | 80 | 242.9 197.7–298.5ROR 277.5 · χ² 18,902 / p <1e-300 | 228.0 EB05 189.1 · IC025 +6.2 3/3 methods agree | Not in label — unassessed | serious PRR 157.2 | no trial data cached |
| Contraindicated product administered | 218 | 238.5 214.0–265.8ROR 361.2 · χ² 51,022 / p <1e-300 | 232.0 EB05 207.3 · IC025 +7.0 3/3 methods agree | Reporting / coding artifact | serious PRR 179.3 | no trial data cached |
| Bursitis | 71 | 193.9 155.6–241.7ROR 218.0 · χ² 13,363 / p <1e-300 | 183.3 EB05 150.2 · IC025 +6.0 3/3 methods agree | Not in label — unassessed | serious PRR 138.0 | no trial data cached |
| Liver injury | 140 | 190.8 164.7–221.0ROR 243.9 · χ² 26,117 / p <1e-300 | 184.9 EB05 160.6 · IC025 +6.5 3/3 methods agree | Not in label — unassessed | serious PRR 119.6 | no trial data cached |
| Joint range of motion decreased | 76 | 187.3 151.6–231.5ROR 212.5 · χ² 13,829 / p <1e-300 | 178.0 EB05 146.9 · IC025 +6.0 3/3 methods agree | Not in label — unassessed | serious PRR 144.4 | no trial data cached |
| Prescribed overdose | 105 | 178.7 150.0–213.0ROR 213.6 · χ² 18,296 / p <1e-300 | 172.2 EB05 146.3 · IC025 +6.3 3/3 methods agree | Not in label — unassessed | serious PRR 184.4 | no trial data cached |
| Fibromyalgia | 127 | 172.2 147.3–201.3ROR 214.6 · χ² 21,359 / p <1e-300 | 167.0 EB05 144.0 · IC025 +6.4 3/3 methods agree | Not in label — unassessed | serious PRR 137.0 | no trial data cached |
| Arthropathy | 277 | 163.5 149.6–178.7ROR 287.5 · χ² 44,470 / p <1e-300 | 160.9 EB05 145.6 · IC025 +6.8 3/3 methods agree | Not in label — unassessed | serious PRR 120.6 | no trial data cached |
| Laryngitis | 52 | 157.7 121.4–204.7ROR 171.5 · χ² 7,905 / p <1e-300 | 148.5 EB05 117.6 · IC025 +5.5 3/3 methods agree | Not in label — unassessed | serious n=52 · 94% clinician | no trial data cached |
| Hip arthroplasty | 72 | 156.1 125.5–194.1ROR 175.7 · χ² 10,895 / p <1e-300 | 149.2 EB05 122.5 · IC025 +5.8 3/3 methods agree | Not in label — unassessed | serious PRR 97.4 | no trial data cached |
| Type 2 diabetes mellitus | 159 | 155.0 135.4–177.4ROR 205.9 · χ² 24,093 / p <1e-300 | 151.5 EB05 132.7 · IC025 +6.4 3/3 methods agree | Labeled (related wording) related wording | serious PRR 98.8 | no trial data cached |
| Red blood cell sedimentation rate increased | 52 | 154.3 118.9–200.4ROR 167.9 · χ² 7,736 / p <1e-300 | 145.5 EB05 115.2 · IC025 +5.5 3/3 methods agree | Lab value / disease marker | serious PRR 105.9 | no trial data cached |
| Irritable bowel syndrome | 99 | 152.5 127.2–182.9ROR 180.2 · χ² 14,695 / p <1e-300 | 147.5 EB05 124.7 · IC025 +6.1 3/3 methods agree | Not in label — unassessed | serious PRR 117.2 | no trial data cached |
| Lower limb fracture | 87 | 149.9 123.3–182.4ROR 173.4 · χ² 12,676 / p <1e-300 | 144.6 EB05 120.8 · IC025 +6.0 3/3 methods agree | Not in label — unassessed | serious PRR 99.7 | no trial data cached |
| Discomfort | 262 | 142.2 129.5–156.1ROR 240.1 · χ² 36,543 / p <1e-300 | 140.2 EB05 126.5 · IC025 +6.6 3/3 methods agree | Not in label — unassessed | serious PRR 151.6 | no trial data cached |
| Sciatica | 68 | 141.1 112.6–176.7ROR 157.7 · χ² 9,284 / p <1e-300 | 135.2 EB05 110.3 · IC025 +5.7 3/3 methods agree | Not in label — unassessed | serious PRR 114.8 | no trial data cached |
| Prescribed underdose | 82 | 135.2 110.4–165.6ROR 155.0 · χ² 10,758 / p <1e-300 | 130.6 EB05 108.6 · IC025 +5.9 3/3 methods agree | Not in label — unassessed | serious PRR 140.0 | no trial data cached |
| Infusion related reaction (reaction during infusion) | 262 | 130.5 118.8–143.2ROR 220.2 · χ² 33,503 / p <1e-300 | 128.8 EB05 116.2 · IC025 +6.5 3/3 methods agree | Not in label — unassessed | serious PRR 99.7 | no trial data cached |
| Foot deformity | 43 | 127.4 95.4–170.2ROR 136.5 · χ² 5,250 / p <1e-300 | 120.3 EB05 93.0 · IC025 +5.2 3/3 methods agree | Not in label — unassessed | serious PRR 89.7 · 91% clinician | no trial data cached |
| Pulmonary fibrosis | 74 | 127.3 102.7–157.8ROR 143.9 · χ² 9,122 / p <1e-300 | 122.9 EB05 101.1 · IC025 +5.7 3/3 methods agree | Not in label — unassessed | serious PRR 78.0 | no trial data cached |
| Maternal exposure during pregnancy | 316 | 117.8 108.9–127.5ROR 231.7 · χ² 36,500 / p <1e-300 | 116.6 EB05 106.2 · IC025 +6.4 3/3 methods agree | Reporting / coding artifact | serious PRR 91.0 | no trial data cached |
| Therapeutic product effect decreased | 159 | 117.8 102.9–134.8ROR 156.4 · χ² 18,269 / p <1e-300 | 115.8 EB05 101.4 · IC025 +6.2 3/3 methods agree | Reporting / coding artifact | serious PRR 140.9 | no trial data cached |
| Psoriatic arthropathy | 143 | 116.9 101.2–135.1ROR 150.3 · χ² 16,290 / p <1e-300 | 114.7 EB05 99.8 · IC025 +6.1 3/3 methods agree | Not in label — unassessed | serious PRR 89.2 | no trial data cached |
| Hepatic enzyme increased | 234 | 113.2 102.2–125.4ROR 177.9 · χ² 25,905 / p <1e-300 | 111.8 EB05 100.3 · IC025 +6.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 99.3 | no trial data cached |
| Knee arthroplasty | 71 | 111.9 89.9–139.5ROR 125.8 · χ² 7,677 / p <1e-300 | 108.4 EB05 88.8 · IC025 +5.6 3/3 methods agree | Not in label — unassessed | serious PRR 70.6 · 90% clinician | no trial data cached |
| Joint dislocation | 35 | 109.3 79.1–150.9ROR 115.5 · χ² 3,636 / p <1e-300 | 102.9 EB05 77.4 · IC025 +4.9 3/3 methods agree | Not in label — unassessed | serious PRR 74.5 | no trial data cached |
| Obesity | 52 | 107.1 82.5–139.1ROR 116.5 · χ² 5,347 / p <1e-300 | 102.8 EB05 81.4 · IC025 +5.3 3/3 methods agree | Not in label — unassessed | serious PRR 75.4 · 90% clinician | no trial data cached |
| Impaired healing | 106 | 106.1 89.1–126.3ROR 127.0 · χ² 10,912 / p <1e-300 | 103.8 EB05 88.3 · IC025 +5.8 3/3 methods agree | Reporting / coding artifact | serious PRR 77.8 | no trial data cached |
| Swelling | 291 | 102.4 94.1–111.5ROR 187.0 · χ² 29,160 / p <1e-300 | 101.4 EB05 92.0 · IC025 +6.2 3/3 methods agree | Not in label — unassessed | serious PRR 100.7 | 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 |
|---|---|---|---|---|---|---|
| Abdominal discomfort | 348 | 68.4 63.7–73.4ROR 148.6 · χ² 23,165 / p <1e-300 | 68.0 EB05 62.2 · IC025 +5.8 3/3 methods agree | Not in label — unassessed | serious PRR 92.4 | no trial data cached |
| Pemphigus | 345 | 935.4 868.8–1,007.1ROR 2,028.1 · χ² 312,237 / p <1e-300 | 865.1 EB05 791.2 · IC025 +8.4 3/3 methods agree | Not in label — unassessed | serious PRR 554.4 | no trial data cached |
| Pain | 343 | 18.3 17.0–19.6ROR 38.2 · χ² 5,749 / p <1e-300 | 18.2 EB05 16.7 · IC025 +4.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 17.5 | no trial data cached |
| Rheumatoid arthritis | 340 | 98.8 91.9–106.3ROR 209.7 · χ² 32,900 / p <1e-300 | 98.0 EB05 89.6 · IC025 +6.3 3/3 methods agree | Not in label — unassessed | serious PRR 73.2 | no trial data cached |
| Systemic lupus erythematosus | 335 | 313.2 290.7–337.5ROR 656.2 · χ² 103,132 / p <1e-300 | 304.8 EB05 278.4 · IC025 +7.5 3/3 methods agree | Not in label — unassessed | serious PRR 193.6 | no trial data cached |
| Alopecia (hair loss) | 329 | 54.9 50.9–59.2ROR 111.9 · χ² 17,482 / p <1e-300 | 54.6 EB05 49.8 · IC025 +5.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 71.3 | no trial data cached |
| Maternal exposure during pregnancy | 316 | 117.8 108.9–127.5ROR 231.7 · χ² 36,500 / p <1e-300 | 116.6 EB05 106.2 · IC025 +6.4 3/3 methods agree | Reporting / coding artifact | serious PRR 91.0 | no trial data cached |
| Glossodynia (burning tongue/mouth pain) | 309 | 459.2 423.4–498.1ROR 887.0 · χ² 139,000 / p <1e-300 | 440.4 EB05 400.7 · IC025 +7.8 3/3 methods agree | Labeled (related wording) related wording | serious PRR 398.7 | no trial data cached |
| Hand deformity | 305 | 782.1 719.8–849.9ROR 1,493.3 · χ² 231,702 / p <1e-300 | 728.5 EB05 662.4 · IC025 +8.2 3/3 methods agree | Not in label — unassessed | serious PRR 505.0 | no trial data cached |
| Wound | 295 | 351.4 322.9–382.4ROR 651.0 · χ² 101,747 / p <1e-300 | 339.9 EB05 308.6 · IC025 +7.6 3/3 methods agree | Not in label — unassessed | serious PRR 251.7 | no trial data cached |
| Swelling | 291 | 102.4 94.1–111.5ROR 187.0 · χ² 29,160 / p <1e-300 | 101.4 EB05 92.0 · IC025 +6.2 3/3 methods agree | Not in label — unassessed | serious PRR 100.7 | no trial data cached |
| Rash | 289 | 21.9 20.1–23.8ROR 39.0 · χ² 5,847 / p <1e-300 | 21.8 EB05 19.8 · IC025 +4.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 29.5 | no trial data cached |
| Pericarditis | 289 | 578.3 530.2–630.7ROR 1,053.6 · χ² 163,180 / p <1e-300 | 547.4 EB05 496.5 · IC025 +8.0 3/3 methods agree | Not in label — unassessed | serious PRR 348.2 | no trial data cached |
| Arthropathy | 277 | 163.5 149.6–178.7ROR 287.5 · χ² 44,470 / p <1e-300 | 160.9 EB05 145.6 · IC025 +6.8 3/3 methods agree | Not in label — unassessed | serious PRR 120.6 | no trial data cached |
| Drug intolerance | 271 | 92.5 84.5–101.3ROR 159.7 · χ² 24,483 / p <1e-300 | 91.7 EB05 82.9 · IC025 +6.1 3/3 methods agree | Reporting / coding artifact | serious PRR 91.5 | 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.
- Pemphigus — n=345, PRR 935.4
- Hand deformity — n=305, PRR 782.1
- Helicobacter infection — n=192, PRR 628.9
- Pericarditis — n=289, PRR 578.3
- Synovitis — n=257, PRR 473.3
- Folliculitis — n=121, PRR 388.3
- Wound — n=295, PRR 351.4
- Autoimmune disorder — n=94, PRR 324.9
- Systemic lupus erythematosus — n=335, PRR 313.2
- Hypercholesterolaemia — n=73, PRR 251.9
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 and Pseudoephedrine?
In FDA FAERS, the most frequently co-reported reaction terms for Cetirizine and Pseudoephedrine are abdominal discomfort, pemphigus, pain, rheumatoid arthritis, systemic lupus erythematosus, alopecia. 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 and Pseudoephedrine have an FDA boxed warning?
No. The FDA label retrieved for Cetirizine and Pseudoephedrine has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Cetirizine and Pseudoephedrine 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, 134 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.