Drug · FAERS side-effect profile with label screen
Fexofenadine HCL side effects: what 9,187 FDA adverse event reports show
Drug class
Not stated in label
Who reports
9,187 reports · 62% serious · 549 with death outcome · 64% female
openFDA FAERS counts, all years, deduplication not applied
Used for
temporarily relieves these symptoms due to hay fever or other respiratory allergies: runny nose sneezing itchy, watery eyes itching of the nose or throat
FDA label, Indications and Usage
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
Reporting / coding artifact 3Lab value / disease marker 1No label text to screen 36
What the badges mean
- 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.
- No label text to screen No validated FDA label was retrievable for this product, so the screen could not run. Disproportionality only.
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. 1,046 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 |
|---|---|---|---|---|---|---|
| Persistent depressive disorder | 12 | 70.3 39.6–124.9ROR 70.4 · χ² 729 / p 6e-161 | 61.8 EB05 37.7 · IC025 +3.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=12 | no trial data cached |
| Neurosis | 13 | 66.9 38.6–116.2ROR 67.0 · χ² 757 / p 5e-167 | 59.6 EB05 37.1 · IC025 +3.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=13 | no trial data cached |
| Mucosal discolouration | 10 | 36.2 19.4–67.7ROR 36.3 · χ² 303 / p 3e-68 | 33.6 EB05 19.4 · IC025 +2.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=10 | no trial data cached |
| Chronic spontaneous urticaria | 17 | 35.7 22.1–57.7ROR 35.8 · χ² 531 / p 8e-118 | 34.0 EB05 22.5 · IC025 +3.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=17 | no trial data cached |
| Pharyngeal hypoaesthesia | 10 | 24.8 13.3–46.2ROR 24.8 · χ² 203 / p 2e-46 | 23.3 EB05 13.1 · IC025 +2.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=8 | no trial data cached |
| Infusion site discharge | 17 | 22.9 14.2–36.9ROR 22.9 · χ² 331 / p 3e-74 | 22.1 EB05 14.5 · IC025 +3.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=12 | no trial data cached |
| Steroid withdrawal syndrome | 10 | 22.6 12.1–42.2ROR 22.6 · χ² 184 / p 4e-42 | 21.2 EB05 11.7 · IC025 +2.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=10 | no trial data cached |
| Lip discolouration | 10 | 18.3 9.8–34.1ROR 18.3 · χ² 145 / p 9e-34 | 16.8 EB05 8.7 · IC025 +2.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=9 | no trial data cached |
| Microcephaly | 10 | 18.1 9.7–33.7ROR 18.1 · χ² 144 / p 2e-33 | 16.6 EB05 8.5 · IC025 +2.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=10 | no trial data cached |
| Quadriparesis | 12 | 16.6 9.4–29.3ROR 16.6 · χ² 160 / p 7e-37 | 15.4 EB05 8.5 · IC025 +2.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=12 | no trial data cached |
| Intellectual disability | 10 | 16.2 8.7–30.2ROR 16.2 · χ² 127 / p 1e-29 | 14.5 EB05 7.3 · IC025 +2.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=10 | no trial data cached |
| Conversion disorder | 13 | 15.4 8.9–26.6ROR 15.5 · χ² 160 / p 5e-37 | 14.3 EB05 8.0 · IC025 +2.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=13 | no trial data cached |
| Infusion site bruising | 13 | 14.0 8.1–24.2ROR 14.0 · χ² 144 / p 2e-33 | 12.7 EB05 7.1 · IC025 +2.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=11 | no trial data cached |
| Skin weeping | 20 | 13.8 8.9–21.4ROR 13.8 · χ² 223 / p 8e-51 | 13.0 EB05 8.4 · IC025 +2.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=19 | no trial data cached |
| Hypopituitarism | 10 | 13.2 7.1–24.5ROR 13.2 · χ² 100 / p 8e-24 | 11.1 EB05 5.6 · IC025 +2.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=10 | no trial data cached |
| Rhinitis allergic | 23 | 11.9 7.9–17.9ROR 11.9 · χ² 217 / p 2e-49 | 11.1 EB05 7.4 · IC025 +2.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=20 | no trial data cached |
| Seasonal allergy | 69 | 11.2 8.8–14.2ROR 11.3 · χ² 628 / p 6e-139 | 10.9 EB05 8.8 · IC025 +3.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=44 · 75% consumer | no trial data cached |
| Extra dose administered | 193 | 11.1 9.6–12.8ROR 11.3 · χ² 1,756 / p <1e-300 | 11.0 EB05 9.7 · IC025 +3.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=5 · 100% consumer | no trial data cached |
| Infusion site pruritus | 15 | 11.0 6.6–18.3ROR 11.0 · χ² 126 / p 1e-29 | 9.6 EB05 5.7 · IC025 +2.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=11 | no trial data cached |
| Psychomotor skills impaired | 12 | 10.5 5.9–18.4ROR 10.5 · χ² 93 / p 3e-22 | 8.7 EB05 4.9 · IC025 +1.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=12 | no trial data cached |
| Product administered to patient of inappropriate age | 26 | 9.9 6.7–14.6ROR 9.9 · χ² 199 / p 2e-45 | 9.1 EB05 6.3 · IC025 +2.4 3/3 methods agree | Reporting / coding artifact | 100% consumer | no trial data cached |
| Respiratory tract infection viral | 10 | 9.9 5.3–18.4ROR 9.9 · χ² 71 / p 2e-17 | 7.8 EB05 4.2 · IC025 +1.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=10 | no trial data cached |
| Sensitive skin | 30 | 9.5 6.6–13.6ROR 9.5 · χ² 218 / p 1e-49 | 8.8 EB05 6.3 · IC025 +2.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=24 · ♀ 100% (drug 64%) · 76% consumer | no trial data cached |
| Device infusion issue | 10 | 9.3 5.0–17.4ROR 9.4 · χ² 66 / p 2e-16 | 7.3 EB05 4.0 · IC025 +1.7 3/3 methods agree | Reporting / coding artifact | serious n=8 | no trial data cached |
| Multiple allergies | 31 | 9.0 6.4–12.9ROR 9.1 · χ² 213 / p 1e-48 | 8.3 EB05 6.0 · IC025 +2.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=26 · ♀ 87% (drug 64%) · 81% consumer | no trial data cached |
| Dermatitis contact | 44 | 8.9 6.6–11.9ROR 8.9 · χ² 298 / p 4e-67 | 8.4 EB05 6.4 · IC025 +2.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=33 · 78% consumer | no trial data cached |
| Nephrogenic anaemia | 18 | 8.8 5.6–14.0ROR 8.8 · χ² 117 / p 2e-27 | 7.6 EB05 4.9 · IC025 +2.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=18 | no trial data cached |
| Infusion site haemorrhage | 12 | 8.5 4.8–14.9ROR 8.5 · χ² 72 / p 1e-17 | 6.8 EB05 4.0 · IC025 +1.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=10 | no trial data cached |
| Infusion site pain | 46 | 8.2 6.2–11.0ROR 8.3 · χ² 285 / p 4e-64 | 7.8 EB05 6.0 · IC025 +2.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=30 · 74% consumer | no trial data cached |
| Respiratory rate decreased | 11 | 8.0 4.4–14.4ROR 8.0 · χ² 60 / p 4e-15 | 6.3 EB05 3.7 · IC025 +1.6 3/3 methods agree | Lab value / disease marker | serious n=10 | no trial data cached |
| Pre-existing condition improved | 22 | 8.0 5.3–12.1ROR 8.0 · χ² 127 / p 9e-30 | 7.1 EB05 4.8 · IC025 +2.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=12 · ♀ 86% (drug 64%) | no trial data cached |
| Infusion site erythema | 27 | 7.5 5.1–10.9ROR 7.5 · χ² 144 / p 2e-33 | 6.7 EB05 4.8 · IC025 +2.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=18 · 78% consumer | no trial data cached |
| Drug eruption | 57 | 7.4 5.7–9.6ROR 7.4 · χ² 308 / p 3e-69 | 7.0 EB05 5.6 · IC025 +2.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.4 | no trial data cached |
| Pemphigoid | 23 | 7.1 4.7–10.7ROR 7.1 · χ² 114 / p 6e-27 | 6.3 EB05 4.4 · IC025 +1.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.7 · ♀ 38% (drug 64%) | no trial data cached |
| Tongue discolouration | 13 | 6.7 3.9–11.6ROR 6.8 · χ² 58 / p 1e-14 | 5.6 EB05 3.4 · IC025 +1.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=13 | no trial data cached |
| Product administration interrupted | 22 | 6.6 4.3–10.0ROR 6.6 · χ² 98 / p 2e-23 | 5.8 EB05 4.0 · IC025 +1.8 3/3 methods agree | Reporting / coding artifact | serious n=18 | no trial data cached |
| Paranasal sinus hypersecretion | 11 | 6.5 3.6–11.8ROR 6.6 · χ² 46 / p 6e-12 | 5.3 EB05 3.1 · IC025 +1.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=7 | no trial data cached |
| Enterocolitis | 16 | 6.4 3.9–10.5ROR 6.4 · χ² 68 / p 1e-16 | 5.5 EB05 3.6 · IC025 +1.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=16 | no trial data cached |
| Infusion site swelling | 17 | 6.3 3.9–10.2ROR 6.3 · χ² 71 / p 2e-17 | 5.5 EB05 3.6 · IC025 +1.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=11 | no trial data cached |
| Skin papilloma | 11 | 6.3 3.5–11.3ROR 6.3 · χ² 43 / p 2e-11 | 5.1 EB05 3.0 · IC025 +1.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=9 | 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) | 823 | 1.4 1.3–1.5ROR 1.5 · χ² 111 / p 2e-26 | 1.4 EB05 1.3 · IC025 +0.4 | Reporting / coding artifact | serious PRR 0.9 · 77% consumer | no trial data cached |
| Nausea | 499 | 1.4 1.3–1.6ROR 1.5 · χ² 70 / p 3e-17 | 1.4 EB05 1.3 · IC025 +0.4 | No label text to screen label has no adverse-reaction text | serious PRR 1.9 | no trial data cached |
| Fatigue (tiredness) | 483 | 1.4 1.3–1.5ROR 1.4 · χ² 62 / p 2e-15 | 1.4 EB05 1.3 · IC025 +0.4 | No label text to screen label has no adverse-reaction text | serious PRR 1.7 | no trial data cached |
| Headache | 463 | 1.7 1.5–1.8ROR 1.7 · χ² 133 / p 5e-31 | 1.7 EB05 1.6 · IC025 +0.6 | No label text to screen label has no adverse-reaction text | serious PRR 2.1 | no trial data cached |
| Diarrhoea (diarrhea) | 462 | 1.6 1.5–1.8ROR 1.7 · χ² 118 / p 8e-28 | 1.6 EB05 1.5 · IC025 +0.6 | No label text to screen label has no adverse-reaction text | serious PRR 1.9 | no trial data cached |
| Dizziness | 417 | 1.9 1.7–2.1ROR 2.0 · χ² 185 / p 2e-42 | 1.9 EB05 1.8 · IC025 +0.8 | No label text to screen label has no adverse-reaction text | serious PRR 2.4 | no trial data cached |
| Dyspnoea (shortness of breath) | 394 | 1.6 1.4–1.8ROR 1.6 · χ² 88 / p 3e-21 | 1.6 EB05 1.5 · IC025 +0.5 | No label text to screen label has no adverse-reaction text | serious PRR 1.6 | no trial data cached |
| Pruritus (itching) | 393 | 2.4 2.2–2.6ROR 2.4 · χ² 316 / p 4e-71 | 2.4 EB05 2.2 · IC025 +1.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 3.5 | no trial data cached |
| Product quality issue | 359 | 6.1 5.5–6.7ROR 6.3 · χ² 1,528 / p <1e-300 | 6.0 EB05 5.5 · IC025 +2.4 3/3 methods agree | Reporting / coding artifact | serious PRR 1.5 · 95% consumer | no trial data cached |
| Rash | 341 | 1.8 1.6–2.0ROR 1.8 · χ² 122 / p 1e-28 | 1.8 EB05 1.6 · IC025 +0.7 | No label text to screen label has no adverse-reaction text | serious PRR 2.4 | no trial data cached |
| Pain | 296 | 1.1 1.0–1.2ROR 1.1 · χ² 3 / p 0.055 | 1.1 EB05 1.0 · IC025 -0.1 PRR-only: not supported by EBGM or IC | No label text to screen label has no adverse-reaction text | serious PRR 1.2 | no trial data cached |
| Malaise (feeling unwell) | 285 | 1.5 1.3–1.7ROR 1.5 · χ² 45 / p 1e-11 | 1.5 EB05 1.3 · IC025 +0.4 | No label text to screen label has no adverse-reaction text | serious PRR 1.7 | no trial data cached |
| Pyrexia (fever) | 270 | 1.8 1.6–2.0ROR 1.8 · χ² 93 / p 3e-22 | 1.8 EB05 1.6 · IC025 +0.6 | No label text to screen label has no adverse-reaction text | serious PRR 1.8 | no trial data cached |
| Vomiting | 266 | 1.3 1.1–1.5ROR 1.3 · χ² 18 / p 1e-5 | 1.3 EB05 1.2 · IC025 +0.2 | No label text to screen label has no adverse-reaction text | serious PRR 1.4 | no trial data cached |
| Cough | 266 | 2.2 1.9–2.4ROR 2.2 · χ² 169 / p 7e-39 | 2.2 EB05 2.0 · IC025 +0.9 | No label text to screen label has no adverse-reaction text | serious PRR 2.0 | no trial data cached |
Unlabeled candidate signals
Every screened signal with n ≥ 20 was either labeled, an indication term, or an artifact pattern — no unlabeled candidate stood out in the top signals.
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 Fexofenadine?
In FDA FAERS, the most frequently co-reported reaction terms for Fexofenadine are nausea, fatigue, headache, diarrhoea, dizziness, dyspnoea. 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 Fexofenadine have an FDA boxed warning?
No. The FDA label retrieved for Fexofenadine has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Fexofenadine 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 579c7ff9-0c44-1d46-e063-6294a90aef34, effective 20260727; matched on
openfda.generic_name.exact:"FEXOFENADINE") - 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, 1,086 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.