Drug · FAERS side-effect profile with label screen
Cetirizine and Pseudoephedrine side effects: what 2,990 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
2,990 reports · 37% serious · 307 with death outcome · 77% 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 3Lab value / disease marker 2Not 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. 186 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 | 322 | 186.2 167.7–206.7ROR 208.5 · χ² 57,603 / p <1e-300 | 179.4 EB05 163.5 · IC025 +7.0 3/3 methods agree | Not in label — unassessed | serious PRR 279.7 · ♀ 100% (drug 77%) | no trial data cached |
| Hand deformity | 288 | 157.6 141.0–176.1ROR 174.2 · χ² 43,686 / p <1e-300 | 152.6 EB05 138.3 · IC025 +6.7 3/3 methods agree | Not in label — unassessed | serious PRR 257.8 · ♀ 100% (drug 77%) | no trial data cached |
| Helicobacter infection | 200 | 140.1 122.4–160.4ROR 150.0 · χ² 26,948 / p <1e-300 | 135.6 EB05 120.5 · IC025 +6.4 3/3 methods agree | Not in label — unassessed | serious PRR 223.2 · ♀ 100% (drug 77%) | no trial data cached |
| Pericarditis | 272 | 116.2 103.6–130.2ROR 127.7 · χ² 30,453 / p <1e-300 | 113.4 EB05 102.5 · IC025 +6.4 3/3 methods agree | Not in label — unassessed | serious PRR 177.2 · ♀ 100% (drug 77%) | no trial data cached |
| Synovitis | 246 | 96.7 85.7–109.1ROR 105.3 · χ² 22,913 / p <1e-300 | 94.7 EB05 85.2 · IC025 +6.1 3/3 methods agree | Not in label — unassessed | serious PRR 153.7 · ♀ 100% (drug 77%) | no trial data cached |
| Glossodynia (burning tongue/mouth pain) | 293 | 93.0 83.3–103.7ROR 102.9 · χ² 26,241 / p <1e-300 | 91.2 EB05 82.8 · IC025 +6.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 204.3 · ♀ 100% (drug 77%) | no trial data cached |
| Folliculitis | 134 | 92.0 77.9–108.7ROR 96.3 · χ² 11,820 / p <1e-300 | 89.7 EB05 77.6 · IC025 +5.8 3/3 methods agree | Not in label — unassessed | serious PRR 164.2 · ♀ 100% (drug 77%) | no trial data cached |
| Autoimmune disorder | 107 | 79.1 65.6–95.4ROR 82.0 · χ² 8,088 / p <1e-300 | 77.2 EB05 65.7 · IC025 +5.5 3/3 methods agree | Not in label — unassessed | serious PRR 128.7 · ♀ 100% (drug 77%) | no trial data cached |
| Wound | 283 | 72.0 64.4–80.5ROR 79.4 · χ² 19,563 / p <1e-300 | 70.9 EB05 64.3 · IC025 +5.8 3/3 methods agree | Not in label — unassessed | serious PRR 129.6 · ♀ 99% (drug 77%) | no trial data cached |
| Systemic lupus erythematosus | 313 | 62.5 56.2–69.4ROR 69.7 · χ² 18,741 / p <1e-300 | 61.7 EB05 56.2 · IC025 +5.6 3/3 methods agree | Not in label — unassessed | serious PRR 97.8 · ♀ 100% (drug 77%) | no trial data cached |
| Wound infection | 92 | 59.8 48.8–73.1ROR 61.6 · χ² 5,214 / p <1e-300 | 58.6 EB05 49.2 · IC025 +5.1 3/3 methods agree | Not in label — unassessed | serious PRR 97.8 · ♀ 100% (drug 77%) | no trial data cached |
| Hypercholesterolaemia | 78 | 57.5 46.2–71.7ROR 59.0 · χ² 4,243 / p <1e-300 | 56.3 EB05 46.6 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious PRR 93.3 · ♀ 100% (drug 77%) | no trial data cached |
| Bursitis | 84 | 49.1 39.7–60.6ROR 50.5 · χ² 3,883 / p <1e-300 | 48.2 EB05 40.2 · IC025 +4.9 3/3 methods agree | Not in label — unassessed | serious PRR 88.2 · ♀ 100% (drug 77%) | no trial data cached |
| Contraindicated product administered | 206 | 48.1 42.2–54.9ROR 51.6 · χ² 9,410 / p <1e-300 | 47.6 EB05 42.4 · IC025 +5.2 3/3 methods agree | Reporting / coding artifact | serious PRR 90.3 · ♀ 99% (drug 77%) | no trial data cached |
| Joint range of motion decreased | 87 | 45.9 37.3–56.5ROR 47.2 · χ² 3,751 / p <1e-300 | 45.1 EB05 37.7 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious PRR 89.3 · ♀ 100% (drug 77%) | no trial data cached |
| Liver injury | 154 | 44.9 38.4–52.4ROR 47.2 · χ² 6,526 / p <1e-300 | 44.4 EB05 38.8 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious PRR 71.1 · ♀ 100% (drug 77%) | no trial data cached |
| Prescribed overdose | 123 | 44.8 37.6–53.3ROR 46.7 · χ² 5,192 / p <1e-300 | 44.2 EB05 38.0 · IC025 +4.9 3/3 methods agree | Not in label — unassessed | serious PRR 115.8 | no trial data cached |
| Fibromyalgia | 147 | 42.6 36.4–49.9ROR 44.8 · χ² 5,905 / p <1e-300 | 42.2 EB05 36.7 · IC025 +4.9 3/3 methods agree | Not in label — unassessed | serious PRR 84.6 · ♀ 100% (drug 77%) | no trial data cached |
| Irritable bowel syndrome | 116 | 38.2 32.0–45.7ROR 39.7 · χ² 4,148 / p <1e-300 | 37.8 EB05 32.4 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious PRR 74.2 · ♀ 98% (drug 77%) | no trial data cached |
| Laryngitis | 58 | 37.6 29.1–48.5ROR 38.3 · χ² 2,020 / p <1e-300 | 37.0 EB05 29.7 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious n=58 · ♀ 100% (drug 77%) | no trial data cached |
| Lower limb fracture | 102 | 37.6 31.0–45.5ROR 38.9 · χ² 3,580 / p <1e-300 | 37.2 EB05 31.5 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious PRR 63.2 · ♀ 100% (drug 77%) | no trial data cached |
| Hip arthroplasty | 80 | 37.1 29.8–46.0ROR 38.1 · χ² 2,759 / p <1e-300 | 36.6 EB05 30.3 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious PRR 58.5 · ♀ 100% (drug 77%) · 92% clinician | no trial data cached |
| Sciatica | 81 | 35.9 29.0–44.6ROR 36.9 · χ² 2,704 / p <1e-300 | 35.5 EB05 29.5 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious PRR 73.9 · ♀ 100% (drug 77%) | no trial data cached |
| Type 2 diabetes mellitus | 172 | 35.8 31.0–41.4ROR 38.0 · χ² 5,769 / p <1e-300 | 35.5 EB05 31.3 · IC025 +4.8 3/3 methods agree | Labeled (related wording) related wording | serious PRR 57.8 · ♀ 100% (drug 77%) | no trial data cached |
| Red blood cell sedimentation rate increased | 56 | 35.5 27.4–46.1ROR 36.2 · χ² 1,836 / p <1e-300 | 35.0 EB05 27.9 · IC025 +4.3 3/3 methods agree | Lab value / disease marker | serious PRR 61.7 · ♀ 100% (drug 77%) | no trial data cached |
| Arthropathy | 269 | 33.9 30.3–38.0ROR 37.2 · χ² 8,543 / p <1e-300 | 33.7 EB05 30.4 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious PRR 62.8 · ♀ 100% (drug 77%) | no trial data cached |
| Prescribed underdose | 86 | 30.3 24.6–37.3ROR 31.2 · χ² 2,400 / p <1e-300 | 30.0 EB05 25.1 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious PRR 79.4 · ♀ 100% (drug 77%) | no trial data cached |
| Discomfort | 257 | 29.8 26.5–33.5ROR 32.5 · χ² 7,115 / p <1e-300 | 29.6 EB05 26.7 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious PRR 78.2 · ♀ 99% (drug 77%) | no trial data cached |
| Pulmonary fibrosis | 80 | 29.4 23.7–36.5ROR 30.2 · χ² 2,161 / p <1e-300 | 29.1 EB05 24.1 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious PRR 45.6 · ♀ 100% (drug 77%) | no trial data cached |
| Foot deformity | 45 | 28.5 21.3–38.1ROR 28.9 · χ² 1,162 / p 4e-255 | 28.1 EB05 21.9 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious PRR 50.8 · ♀ 100% (drug 77%) | no trial data cached |
| Psoriatic arthropathy | 162 | 28.3 24.4–32.9ROR 29.9 · χ² 4,232 / p <1e-300 | 28.1 EB05 24.7 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious PRR 54.3 · ♀ 100% (drug 77%) | no trial data cached |
| Knee arthroplasty | 83 | 28.0 22.6–34.6ROR 28.7 · χ² 2,126 / p <1e-300 | 27.7 EB05 23.1 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious PRR 44.6 · ♀ 99% (drug 77%) · 92% clinician | no trial data cached |
| Infusion related reaction (reaction during infusion) | 258 | 27.5 24.4–30.9ROR 29.9 · χ² 6,544 / p <1e-300 | 27.3 EB05 24.6 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious PRR 52.2 · ♀ 99% (drug 77%) | no trial data cached |
| Obesity | 62 | 27.3 21.3–35.0ROR 27.9 · χ² 1,540 / p <1e-300 | 27.0 EB05 21.8 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious PRR 47.8 · ♀ 100% (drug 77%) | no trial data cached |
| Therapeutic product effect decreased | 171 | 27.1 23.4–31.3ROR 28.7 · χ² 4,261 / p <1e-300 | 26.9 EB05 23.7 · IC025 +4.4 3/3 methods agree | Reporting / coding artifact | serious PRR 78.1 · ♀ 99% (drug 77%) | no trial data cached |
| Joint dislocation | 40 | 26.7 19.6–36.3ROR 27.0 · χ² 960 / p 4e-211 | 26.3 EB05 20.1 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious PRR 44.9 · ♀ 100% (drug 77%) | no trial data cached |
| Impaired healing | 124 | 26.5 22.3–31.5ROR 27.6 · χ² 3,015 / p <1e-300 | 26.3 EB05 22.7 · IC025 +4.3 3/3 methods agree | Reporting / coding artifact | serious PRR 49.2 · ♀ 99% (drug 77%) | no trial data cached |
| Blood cholesterol increased | 162 | 24.4 21.0–28.4ROR 25.7 · χ² 3,607 / p <1e-300 | 24.3 EB05 21.3 · IC025 +4.2 3/3 methods agree | Lab value / disease marker | serious PRR 56.7 · ♀ 98% (drug 77%) | no trial data cached |
| Gait inability | 114 | 24.2 20.2–29.0ROR 25.1 · χ² 2,507 / p <1e-300 | 24.0 EB05 20.5 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious PRR 45.4 · ♀ 99% (drug 77%) | no trial data cached |
| Hepatic enzyme increased | 229 | 23.7 20.9–26.8ROR 25.5 · χ² 4,948 / p <1e-300 | 23.6 EB05 21.1 · IC025 +4.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 51.8 · ♀ 100% (drug 77%) | 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 |
|---|---|---|---|---|---|---|
| Drug ineffective (drug did not work) | 559 | 3.0 2.8–3.2ROR 3.4 · χ² 779 / p 1e-171 | 3.0 EB05 2.8 · IC025 +1.4 3/3 methods agree | Reporting / coding artifact | serious PRR 8.1 | no trial data cached |
| Fatigue (tiredness) | 411 | 3.7 3.4–4.1ROR 4.1 · χ² 840 / p 6e-185 | 3.7 EB05 3.4 · IC025 +1.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 8.8 | no trial data cached |
| Pain | 404 | 4.6 4.2–5.0ROR 5.2 · χ² 1,168 / p 3e-256 | 4.6 EB05 4.2 · IC025 +2.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 10.0 | no trial data cached |
| Rash | 356 | 5.8 5.2–6.3ROR 6.4 · χ² 1,421 / p <1e-300 | 5.7 EB05 5.2 · IC025 +2.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 16.2 | no trial data cached |
| Abdominal discomfort | 336 | 14.1 12.7–15.6ROR 15.8 · χ² 4,101 / p <1e-300 | 14.1 EB05 12.8 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious PRR 47.0 · ♀ 98% (drug 77%) | no trial data cached |
| Alopecia (hair loss) | 329 | 11.7 10.6–13.0ROR 13.0 · χ² 3,242 / p <1e-300 | 11.7 EB05 10.6 · IC025 +3.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 36.8 · ♀ 100% (drug 77%) | no trial data cached |
| Rheumatoid arthritis | 324 | 20.1 18.1–22.3ROR 22.4 · χ² 5,882 / p <1e-300 | 20.0 EB05 18.3 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious PRR 37.6 · ♀ 100% (drug 77%) | no trial data cached |
| Pemphigus | 322 | 186.2 167.7–206.7ROR 208.5 · χ² 57,603 / p <1e-300 | 179.4 EB05 163.5 · IC025 +7.0 3/3 methods agree | Not in label — unassessed | serious PRR 279.7 · ♀ 100% (drug 77%) | no trial data cached |
| Systemic lupus erythematosus | 313 | 62.5 56.2–69.4ROR 69.7 · χ² 18,741 / p <1e-300 | 61.7 EB05 56.2 · IC025 +5.6 3/3 methods agree | Not in label — unassessed | serious PRR 97.8 · ♀ 100% (drug 77%) | no trial data cached |
| Product use issue | 302 | 11.3 10.2–12.6ROR 12.5 · χ² 2,854 / p <1e-300 | 11.3 EB05 10.2 · IC025 +3.3 3/3 methods agree | Reporting / coding artifact | serious PRR 23.7 | no trial data cached |
| Maternal exposure during pregnancy | 295 | 23.5 21.1–26.2ROR 25.9 · χ² 6,335 / p <1e-300 | 23.4 EB05 21.2 · IC025 +4.3 3/3 methods agree | Reporting / coding artifact | serious PRR 45.8 · ♀ 100% (drug 77%) | no trial data cached |
| Glossodynia (burning tongue/mouth pain) | 293 | 93.0 83.3–103.7ROR 102.9 · χ² 26,241 / p <1e-300 | 91.2 EB05 82.8 · IC025 +6.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 204.3 · ♀ 100% (drug 77%) | no trial data cached |
| Swelling | 288 | 21.7 19.4–24.2ROR 23.9 · χ² 5,661 / p <1e-300 | 21.6 EB05 19.6 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious PRR 52.8 · ♀ 99% (drug 77%) | no trial data cached |
| Hand deformity | 288 | 157.6 141.0–176.1ROR 174.2 · χ² 43,686 / p <1e-300 | 152.6 EB05 138.3 · IC025 +6.7 3/3 methods agree | Not in label — unassessed | serious PRR 257.8 · ♀ 100% (drug 77%) | no trial data cached |
| Wound | 283 | 72.0 64.4–80.5ROR 79.4 · χ² 19,563 / p <1e-300 | 70.9 EB05 64.3 · IC025 +5.8 3/3 methods agree | Not in label — unassessed | serious PRR 129.6 · ♀ 99% (drug 77%) | 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=322, PRR 186.2
- Hand deformity — n=288, PRR 157.6
- Helicobacter infection — n=200, PRR 140.1
- Pericarditis — n=272, PRR 116.2
- Synovitis — n=246, PRR 96.7
- Folliculitis — n=134, PRR 92.0
- Autoimmune disorder — n=107, PRR 79.1
- Wound — n=283, PRR 72.0
- Systemic lupus erythematosus — n=313, PRR 62.5
- Wound infection — n=92, PRR 59.8
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 and Pseudoephedrine?
In FDA FAERS, the most frequently co-reported reaction terms for Cetirizine and Pseudoephedrine 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 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, 226 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.