Drug · FAERS side-effect profile with label screen
Fexofenadine Hydrochloride side effects: what 21,591 FDA adverse event reports show
Drug class
Not stated in label
Who reports
21,591 reports · 33% serious · 690 with death outcome · 69% 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 5No label text to screen 35
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.
- 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. 1,093 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 |
|---|---|---|---|---|---|---|
| Vascular access site complication | 13 | 54.3 31.1–94.9ROR 54.3 · χ² 594 / p 2e-131 | 48.1 EB05 29.9 · IC025 +3.2 3/3 methods agree | Reporting / coding artifact | – | not reported in cached trials |
| Neurosis | 14 | 30.7 18.0–52.3ROR 30.7 · χ² 362 / p 6e-81 | 28.7 EB05 18.2 · IC025 +3.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=13 | not reported in cached trials |
| Persistent depressive disorder | 12 | 29.9 16.8–53.1ROR 29.9 · χ² 298 / p 6e-67 | 27.8 EB05 16.9 · IC025 +2.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=12 | not reported in cached trials |
| Labelled drug-food interaction medication error | 11 | 21.7 11.9–39.4ROR 21.7 · χ² 192 / p 5e-44 | 20.2 EB05 11.4 · IC025 +2.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | – | not reported in cached trials |
| Nasal pruritus | 25 | 19.9 13.4–29.6ROR 20.0 · χ² 422 / p 5e-94 | 19.2 EB05 13.6 · IC025 +3.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | 84% consumer | not reported in cached trials |
| Infusion site discharge | 31 | 17.9 12.5–25.5ROR 17.9 · χ² 469 / p 3e-104 | 17.4 EB05 12.7 · IC025 +3.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=21 · ♀ 100% (drug 69%) · 81% consumer | not reported in cached trials |
| Extra dose administered | 718 | 17.8 16.5–19.1ROR 18.3 · χ² 11,160 / p <1e-300 | 17.5 EB05 16.4 · IC025 +4.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=15 · 98% consumer | not reported in cached trials |
| Chronic spontaneous urticaria | 19 | 17.0 10.8–26.8ROR 17.0 · χ² 266 / p 5e-60 | 16.2 EB05 10.6 · IC025 +2.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=17 | not reported in cached trials |
| Pre-existing condition improved | 102 | 15.9 13.1–19.4ROR 16.0 · χ² 1,389 / p <1e-300 | 15.6 EB05 13.2 · IC025 +3.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=52 | not reported in cached trials |
| Infusion site bruising | 34 | 15.8 11.2–22.1ROR 15.8 · χ² 448 / p 1e-99 | 15.3 EB05 11.3 · IC025 +3.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=30 · ♀ 91% (drug 69%) | not reported in cached trials |
| Croup infectious | 11 | 14.0 7.7–25.3ROR 14.0 · χ² 118 / p 8e-28 | 12.2 EB05 6.3 · IC025 +2.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=11 | not reported in cached trials |
| Seasonal allergy | 194 | 13.5 11.7–15.6ROR 13.6 · χ² 2,205 / p <1e-300 | 13.3 EB05 11.8 · IC025 +3.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=114 · 73% consumer | not reported in cached trials |
| Wrong dose | 32 | 13.0 9.1–18.4ROR 13.0 · χ² 337 / p 1e-75 | 12.4 EB05 8.9 · IC025 +2.8 3/3 methods agree | Reporting / coding artifact | 100% consumer | not reported in cached trials |
| Mast cell activation syndrome | 16 | 11.9 7.2–19.4ROR 11.9 · χ² 147 / p 5e-34 | 10.5 EB05 6.4 · IC025 +2.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=16 | not reported in cached trials |
| Infusion site pruritus | 37 | 11.6 8.4–16.1ROR 11.7 · χ² 345 / p 2e-77 | 11.1 EB05 8.2 · IC025 +2.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=25 · ♀ 92% (drug 69%) | NCT00502775: 1/229 (0.4%) control |
| Infusion site irritation | 14 | 11.0 6.5–18.7ROR 11.0 · χ² 117 / p 2e-27 | 9.5 EB05 5.5 · IC025 +2.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=7 | NCT00502775: 1/229 (0.4%) control |
| Multiple allergies | 84 | 10.5 8.5–13.0ROR 10.5 · χ² 704 / p 2e-155 | 10.2 EB05 8.4 · IC025 +2.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=68 · ♀ 94% (drug 69%) · 72% consumer | not reported in cached trials |
| Sleep-related eating disorder | 10 | 10.4 5.6–19.5ROR 10.4 · χ² 75 / p 2e-18 | 8.2 EB05 4.4 · IC025 +1.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=7 | not reported in cached trials |
| Cataplexy | 15 | 10.3 6.2–17.1ROR 10.3 · χ² 115 / p 3e-27 | 8.8 EB05 5.3 · IC025 +2.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=12 | not reported in cached trials |
| Sneezing | 233 | 10.2 9.0–11.6ROR 10.3 · χ² 1,908 / p <1e-300 | 10.0 EB05 9.0 · IC025 +3.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.3 · 87% consumer | not reported in cached trials |
| Skin weeping | 34 | 10.0 7.1–14.0ROR 10.0 · χ² 264 / p 1e-59 | 9.3 EB05 6.8 · IC025 +2.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=21 | not reported in cached trials |
| Obstructive sleep apnoea syndrome | 14 | 9.8 5.8–16.6ROR 9.8 · χ² 101 / p 4e-24 | 8.2 EB05 4.9 · IC025 +2.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=14 | not reported in cached trials |
| Infusion site haemorrhage | 32 | 9.7 6.8–13.7ROR 9.7 · χ² 238 / p 6e-54 | 8.9 EB05 6.5 · IC025 +2.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=22 · 78% consumer | NCT00502775: 1/224 (0.4%) on Fexofenadine |
| Steroid withdrawal syndrome | 10 | 9.6 5.2–17.9ROR 9.6 · χ² 68 / p 8e-17 | 7.5 EB05 4.1 · IC025 +1.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=10 | not reported in cached trials |
| Exposure to toxic agent | 30 | 9.1 6.4–13.0ROR 9.1 · χ² 207 / p 4e-47 | 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=28 · 100% clinician | not reported in cached trials |
| Product administration interrupted | 71 | 9.1 7.2–11.4ROR 9.1 · χ² 496 / p 3e-110 | 8.7 EB05 7.1 · IC025 +2.7 3/3 methods agree | Reporting / coding artifact | serious n=64 | not reported in cached trials |
| Nasal septum deviation | 18 | 9.0 5.7–14.3ROR 9.0 · χ² 119 / p 5e-28 | 7.8 EB05 5.0 · IC025 +2.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=15 | not reported in cached trials |
| Postural orthostatic tachycardia syndrome | 12 | 9.0 5.1–15.8ROR 9.0 · χ² 76 / p 1e-18 | 7.2 EB05 4.2 · IC025 +1.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=9 | not reported in cached trials |
| Infusion site warmth | 11 | 8.9 4.9–16.2ROR 9.0 · χ² 69 / p 4e-17 | 7.1 EB05 4.0 · IC025 +1.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=7 | not reported in cached trials |
| Allergic reaction to excipient | 18 | 8.9 5.6–14.2ROR 8.9 · χ² 118 / p 9e-28 | 7.7 EB05 5.0 · IC025 +2.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | – | not reported in cached trials |
| Infusion site rash | 11 | 7.9 4.4–14.3ROR 7.9 · χ² 59 / p 8e-15 | 6.2 EB05 3.6 · IC025 +1.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | – | not reported in cached trials |
| Infusion site pain | 103 | 7.9 6.5–9.6ROR 7.9 · χ² 607 / p 2e-134 | 7.6 EB05 6.4 · IC025 +2.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=68 · 78% consumer | NCT00502775: 3/227 (1.3%) on Fexofenadine; 1/229 (0.4%) control |
| Narcolepsy | 15 | 7.8 4.7–12.9ROR 7.8 · χ² 81 / p 1e-19 | 6.5 EB05 4.1 · IC025 +1.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=12 | not reported in cached trials |
| Microcephaly | 10 | 7.7 4.1–14.3ROR 7.7 · χ² 51 / p 4e-13 | 6.0 EB05 3.4 · IC025 +1.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=10 | not reported in cached trials |
| Infusion site erythema | 65 | 7.7 6.0–9.8ROR 7.7 · χ² 367 / p 4e-82 | 7.3 EB05 5.9 · IC025 +2.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=42 · ♀ 89% (drug 69%) · 78% consumer | not reported in cached trials |
| Product use complaint | 114 | 7.2 6.0–8.6ROR 7.2 · χ² 596 / p 5e-132 | 7.0 EB05 5.9 · IC025 +2.5 3/3 methods agree | Reporting / coding artifact | serious n=20 · 84% consumer | not reported in cached trials |
| Quadriparesis | 12 | 7.1 4.0–12.5ROR 7.1 · χ² 56 / p 3e-14 | 5.7 EB05 3.4 · IC025 +1.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=12 | not reported in cached trials |
| Therapeutic response decreased | 427 | 6.9 6.3–7.6ROR 7.0 · χ² 2,144 / p <1e-300 | 6.8 EB05 6.3 · IC025 +2.6 3/3 methods agree | Reporting / coding artifact | serious PRR 1.5 · 86% consumer | not reported in cached trials |
| Intellectual disability | 10 | 6.9 3.7–12.8ROR 6.9 · χ² 44 / p 1e-11 | 5.4 EB05 3.1 · IC025 +1.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=10 | not reported in cached trials |
| Snoring | 26 | 6.7 4.6–9.9ROR 6.7 · χ² 120 / p 3e-28 | 6.1 EB05 4.3 · IC025 +1.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=11 | 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 Fexofenadine 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 (4 of 40 signal terms matched).
- NCT00435461 — Fluticasone Furoate Nasal Spray Versus Oral Fexofenadine (N=1000, PHASE4; 2 AE terms posted; arms: Placebo; FFNS 110 mcg; Fex 180 mg)
- NCT00502775 — Fluticasone Furoate Nasal Spray Versus Oral Fexofenadine (N=680, PHASE4; 61 AE terms posted; arms: Placebo; Fluticasone Furoate 110mcg; Fexofenadine 180 mg)
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) | 3,734 | 2.8 2.7–2.8ROR 3.1 · χ² 4,447 / p <1e-300 | 2.8 EB05 2.7 · IC025 +1.4 3/3 methods agree | Reporting / coding artifact | serious PRR 1.0 · 89% consumer | not reported in cached trials |
| Headache | 965 | 1.5 1.4–1.6ROR 1.5 · χ² 163 / p 1e-37 | 1.5 EB05 1.4 · IC025 +0.5 | No label text to screen label has no adverse-reaction text | serious PRR 2.3 · 72% consumer | NCT00435461: 12/312 (3.8%) on Fexofenadine; 11/313 (3.5%) control |
| Fatigue (tiredness) | 952 | 1.2 1.1–1.3ROR 1.2 · χ² 30 / p 3e-8 | 1.2 EB05 1.1 · IC025 +0.1 | No label text to screen label has no adverse-reaction text | serious PRR 2.0 | NCT00502775: 1/227 (0.4%) on Fexofenadine; 1/229 (0.4%) control |
| Pruritus (itching) | 909 | 2.3 2.2–2.5ROR 2.4 · χ² 705 / p 1e-155 | 2.3 EB05 2.2 · IC025 +1.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 3.1 | NCT00502775: 1/229 (0.4%) control |
| Nausea | 853 | 1.0 1.0–1.1ROR 1.1 · χ² 2 / p 0.079 | 1.0 EB05 1.0 · IC025 -0.0 PRR-only: not supported by EBGM or IC | No label text to screen label has no adverse-reaction text | serious PRR 1.9 | NCT00502775: 1/227 (0.4%) on Fexofenadine |
| No adverse event | 800 | 4.4 4.1–4.7ROR 4.5 · χ² 2,101 / p <1e-300 | 4.4 EB05 4.1 · IC025 +2.0 3/3 methods agree | Reporting / coding artifact | 94% consumer | not reported in cached trials |
| Diarrhoea (diarrhea) | 762 | 1.1 1.1–1.2ROR 1.2 · χ² 15 / p 5e-5 | 1.1 EB05 1.1 · IC025 +0.1 | No label text to screen label has no adverse-reaction text | serious PRR 1.9 | NCT00502775: 1/227 (0.4%) on Fexofenadine |
| Extra dose administered | 718 | 17.8 16.5–19.1ROR 18.3 · χ² 11,160 / p <1e-300 | 17.5 EB05 16.4 · IC025 +4.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=15 · 98% consumer | not reported in cached trials |
| Dizziness | 716 | 1.4 1.3–1.5ROR 1.4 · χ² 82 / p 7e-20 | 1.4 EB05 1.3 · IC025 +0.4 | No label text to screen label has no adverse-reaction text | serious PRR 2.2 · 70% consumer | NCT00502775: 1/227 (0.4%) on Fexofenadine |
| Rash | 688 | 1.5 1.4–1.7ROR 1.6 · χ² 133 / p 6e-31 | 1.5 EB05 1.4 · IC025 +0.5 | No label text to screen label has no adverse-reaction text | serious PRR 2.4 | not reported in cached trials |
| Dyspnoea (shortness of breath) | 675 | 1.2 1.1–1.2ROR 1.2 · χ² 15 / p 6e-5 | 1.2 EB05 1.1 · IC025 +0.1 | No label text to screen label has no adverse-reaction text | serious PRR 1.6 | not reported in cached trials |
| Somnolence (drowsiness) | 627 | 3.0 2.8–3.3ROR 3.1 · χ² 858 / p 7e-189 | 3.0 EB05 2.8 · IC025 +1.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 2.4 · 84% consumer | NCT00502775: 1/224 (0.4%) on Fexofenadine |
| Cough | 622 | 2.2 2.0–2.3ROR 2.2 · χ² 391 / p 3e-87 | 2.2 EB05 2.0 · IC025 +1.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 2.7 | NCT00502775: 2/227 (0.9%) on Fexofenadine; 1/229 (0.4%) control |
| Pain | 570 | 0.9 0.8–1.0ROR 0.9 · χ² 7 / p 0.005 | 0.9 EB05 0.8 · IC025 -0.3 PRR-only: not supported by EBGM or IC | No label text to screen label has no adverse-reaction text | serious PRR 1.4 | NCT00502775: 3/227 (1.3%) on Fexofenadine; 1/229 (0.4%) control |
| Insomnia (trouble sleeping) | 560 | 2.0 1.9–2.2ROR 2.1 · χ² 299 / p 3e-67 | 2.0 EB05 1.9 · IC025 +0.9 | No label text to screen label has no adverse-reaction text | serious PRR 2.5 · 76% consumer | not reported in cached trials |
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 headache, fatigue, pruritus, nausea, diarrhoea, extra dose administered. 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, 1,133 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
FEXOFENADINE, 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.