Drug · FAERS side-effect profile with label screen
Fexofenadine side effects: what 16,425 FDA adverse event reports show
Drug class
Not stated in label
Who reports
16,425 reports · 74% serious · 860 with death outcome · 67% 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 1Lab value / disease marker 1No label text to screen 38
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. 1,118 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 |
|---|---|---|---|---|---|---|
| Pathergy reaction | 10 | 740.5 339.1–1,616.9ROR 740.9 · χ² 4,195 / p <1e-300 | 246.9 EB05 143.3 · IC025 +3.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=10 | not reported in cached trials |
| Cardiospasm | 43 | 106.6 78.1–145.4ROR 106.8 · χ² 4,049 / p <1e-300 | 94.3 EB05 72.9 · IC025 +5.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=43 · ♀ 100% (drug 67%) | not reported in cached trials |
| Immunisation | 30 | 94.9 65.5–137.5ROR 95.1 · χ² 2,505 / p <1e-300 | 83.7 EB05 61.5 · IC025 +4.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=30 · ♀ 100% (drug 67%) | not reported in cached trials |
| Palmoplantar keratoderma | 43 | 81.0 59.6–110.3ROR 81.2 · χ² 3,119 / p <1e-300 | 73.8 EB05 57.1 · IC025 +4.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=43 · ♀ 100% (drug 67%) | not reported in cached trials |
| Ear infection fungal | 10 | 43.7 23.3–82.1ROR 43.7 · χ² 363 / p 3e-81 | 39.4 EB05 22.8 · IC025 +2.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=10 | NCT00502775: 1/224 (0.4%) on Fexofenadine |
| Drug administered to patient of inappropriate age | 202 | 36.5 31.7–41.9ROR 36.9 · χ² 6,742 / p <1e-300 | 35.4 EB05 31.5 · IC025 +4.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=12 · 100% consumer | not reported in cached trials |
| Neuropsychological symptoms | 14 | 31.6 18.6–53.7ROR 31.6 · χ² 375 / p 7e-84 | 29.7 EB05 18.8 · IC025 +3.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=14 | not reported in cached trials |
| Atrial tachycardia | 49 | 30.3 22.9–40.3ROR 30.4 · χ² 1,329 / p 3e-291 | 29.4 EB05 23.1 · IC025 +4.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=50 · ♀ 90% (drug 67%) | not reported in cached trials |
| Chronic spontaneous urticaria | 25 | 29.6 19.9–44.0ROR 29.6 · χ² 647 / p 4e-143 | 28.4 EB05 20.2 · IC025 +3.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=25 · 100% clinician | not reported in cached trials |
| Mechanical urticaria | 10 | 28.0 15.0–52.5ROR 28.1 · χ² 229 / p 4e-52 | 26.1 EB05 14.9 · IC025 +2.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=10 | not reported in cached trials |
| Urticarial vasculitis | 11 | 27.6 15.2–50.1ROR 27.6 · χ² 250 / p 1e-56 | 25.8 EB05 15.2 · IC025 +2.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=11 | not reported in cached trials |
| Pruritus genital | 45 | 25.1 18.7–33.7ROR 25.2 · χ² 999 / p 2e-219 | 24.4 EB05 19.0 · IC025 +3.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=44 · ♀ 100% (drug 67%) | not reported in cached trials |
| Mast cell activation syndrome | 24 | 23.5 15.7–35.3ROR 23.6 · χ² 487 / p 4e-108 | 22.8 EB05 16.1 · IC025 +3.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=22 | not reported in cached trials |
| Nephrogenic anaemia | 77 | 21.4 17.1–26.7ROR 21.5 · χ² 1,450 / p <1e-300 | 20.9 EB05 17.3 · IC025 +3.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=77 | not reported in cached trials |
| Genital swelling | 11 | 20.8 11.5–37.7ROR 20.8 · χ² 185 / p 2e-42 | 19.5 EB05 10.9 · IC025 +2.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=11 | not reported in cached trials |
| Genital ulceration | 12 | 20.6 11.6–36.3ROR 20.6 · χ² 201 / p 7e-46 | 19.4 EB05 11.3 · IC025 +2.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=12 | not reported in cached trials |
| Chronic kidney disease-mineral and bone disorder | 17 | 20.5 12.7–33.1ROR 20.5 · χ² 291 / p 1e-65 | 19.7 EB05 12.8 · IC025 +2.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=17 | not reported in cached trials |
| Tongue erythema | 12 | 19.1 10.8–33.8ROR 19.1 · χ² 186 / p 1e-42 | 17.9 EB05 10.2 · IC025 +2.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=10 | not reported in cached trials |
| Sleep terror | 59 | 18.1 14.0–23.5ROR 18.2 · χ² 926 / p 1e-203 | 17.8 EB05 14.3 · IC025 +3.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=57 | not reported in cached trials |
| Tension headache | 57 | 17.1 13.2–22.3ROR 17.2 · χ² 839 / p 7e-185 | 16.8 EB05 13.4 · IC025 +3.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=56 | NCT00502775: 1/227 (0.4%) on Fexofenadine; 1/229 (0.4%) control |
| Hyperparathyroidism secondary | 33 | 16.8 12.0–23.7ROR 16.9 · χ² 470 / p 2e-104 | 16.4 EB05 12.1 · IC025 +3.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=33 | not reported in cached trials |
| Psychogenic seizure | 12 | 16.8 9.5–29.7ROR 16.8 · χ² 161 / p 4e-37 | 15.5 EB05 8.6 · IC025 +2.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=12 | not reported in cached trials |
| Essential tremor | 14 | 16.2 9.6–27.4ROR 16.2 · χ² 182 / p 7e-42 | 15.1 EB05 8.9 · IC025 +2.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=14 | not reported in cached trials |
| Carotid artery occlusion | 44 | 15.5 11.5–20.9ROR 15.6 · χ² 576 / p 1e-127 | 15.2 EB05 11.7 · IC025 +3.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=44 · ♀ 100% (drug 67%) | not reported in cached trials |
| Rebound acid hypersecretion | 36 | 15.2 10.9–21.0ROR 15.2 · χ² 456 / p 2e-101 | 14.7 EB05 11.0 · IC025 +3.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=36 | not reported in cached trials |
| Product administered to patient of inappropriate age | 68 | 14.6 11.5–18.5ROR 14.7 · χ² 839 / p 1e-184 | 14.3 EB05 11.6 · IC025 +3.3 3/3 methods agree | Reporting / coding artifact | 100% consumer | not reported in cached trials |
| Vulvovaginal candidiasis | 14 | 13.5 8.0–22.9ROR 13.5 · χ² 149 / p 2e-34 | 12.2 EB05 7.0 · IC025 +2.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=14 | not reported in cached trials |
| Lip swelling | 326 | 12.6 11.3–14.1ROR 12.9 · χ² 3,453 / p <1e-300 | 12.5 EB05 11.4 · IC025 +3.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 14.7 | NCT00502775: 1/227 (0.4%) on Fexofenadine |
| Hypersexuality | 17 | 11.9 7.4–19.2ROR 11.9 · χ² 158 / p 2e-36 | 10.7 EB05 6.6 · IC025 +2.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=16 | not reported in cached trials |
| Bleeding time prolonged | 11 | 11.7 6.5–21.2ROR 11.7 · χ² 96 / p 5e-23 | 9.7 EB05 5.2 · IC025 +2.0 3/3 methods agree | Lab value / disease marker | serious n=11 | not reported in cached trials |
| Sleep paralysis | 13 | 11.4 6.6–19.7ROR 11.4 · χ² 112 / p 1e-26 | 9.8 EB05 5.5 · IC025 +2.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=13 | not reported in cached trials |
| Nasal pruritus | 11 | 11.4 6.3–20.6ROR 11.4 · χ² 93 / p 2e-22 | 9.4 EB05 5.0 · IC025 +1.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | – | not reported in cached trials |
| Mouth swelling | 49 | 11.0 8.3–14.5ROR 11.0 · χ² 430 / p 7e-96 | 10.5 EB05 8.1 · IC025 +2.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=47 · ♀ 90% (drug 67%) | not reported in cached trials |
| Genital rash | 12 | 10.9 6.2–19.2ROR 10.9 · χ² 97 / p 3e-23 | 9.0 EB05 5.0 · IC025 +2.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=10 | not reported in cached trials |
| Conjunctivitis allergic | 12 | 10.5 6.0–18.6ROR 10.6 · χ² 94 / p 2e-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 | not reported in cached trials |
| Pharyngeal swelling | 78 | 10.5 8.4–13.1ROR 10.5 · χ² 654 / p 1e-144 | 10.2 EB05 8.3 · IC025 +2.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=73 | not reported in cached trials |
| Angioedema (deep swelling of face/throat) | 352 | 10.3 9.2–11.4ROR 10.5 · χ² 2,913 / p <1e-300 | 10.1 EB05 9.3 · IC025 +3.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 8.3 | not reported in cached trials |
| Self-injurious ideation | 33 | 10.1 7.2–14.3ROR 10.2 · χ² 261 / p 5e-59 | 9.5 EB05 6.9 · IC025 +2.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=33 · ♀ 100% (drug 67%) | not reported in cached trials |
| Oral pruritus | 18 | 10.1 6.4–16.1ROR 10.1 · χ² 137 / p 5e-32 | 8.9 EB05 5.6 · IC025 +2.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=16 | NCT00502775: 1/229 (0.4%) control |
| Ureteric obstruction | 10 | 9.4 5.0–17.5ROR 9.4 · χ² 66 / p 2e-16 | 7.3 EB05 4.0 · IC025 +1.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=10 | NCT00502775: 1/227 (0.4%) on Fexofenadine (serious AE) |
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 (5 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) | 1,036 | 1.0 0.9–1.1ROR 1.0 · χ² 0 / p 0.446 | 1.0 EB05 1.0 · IC025 -0.1 PRR-only: not supported by EBGM or IC | Reporting / coding artifact | serious PRR 0.9 | not reported in cached trials |
| Nausea | 928 | 1.5 1.4–1.6ROR 1.5 · χ² 161 / p 3e-37 | 1.5 EB05 1.4 · IC025 +0.5 | No label text to screen label has no adverse-reaction text | serious PRR 1.7 | NCT00502775: 1/227 (0.4%) on Fexofenadine |
| Fatigue (tiredness) | 890 | 1.5 1.4–1.6ROR 1.5 · χ² 135 / p 2e-31 | 1.5 EB05 1.4 · IC025 +0.4 | No label text to screen label has no adverse-reaction text | serious PRR 1.6 | NCT00502775: 1/227 (0.4%) on Fexofenadine; 1/229 (0.4%) control |
| Dyspnoea (shortness of breath) | 853 | 1.9 1.8–2.1ROR 2.0 · χ² 389 / p 6e-87 | 1.9 EB05 1.8 · IC025 +0.8 | No label text to screen label has no adverse-reaction text | serious PRR 1.8 | not reported in cached trials |
| Headache | 816 | 1.7 1.6–1.8ROR 1.7 · χ² 222 / p 1e-50 | 1.7 EB05 1.6 · IC025 +0.6 | No label text to screen label has no adverse-reaction text | serious PRR 1.9 | NCT00435461: 12/312 (3.8%) on Fexofenadine; 11/313 (3.5%) control |
| Dizziness | 796 | 2.0 1.9–2.2ROR 2.1 · χ² 432 / p 3e-96 | 2.0 EB05 1.9 · IC025 +0.9 | No label text to screen label has no adverse-reaction text | serious PRR 2.2 | NCT00502775: 1/227 (0.4%) on Fexofenadine |
| Diarrhoea (diarrhea) | 783 | 1.6 1.5–1.7ROR 1.6 · χ² 159 / p 9e-37 | 1.6 EB05 1.5 · IC025 +0.5 | No label text to screen label has no adverse-reaction text | serious PRR 1.6 | NCT00502775: 1/227 (0.4%) on Fexofenadine |
| Pruritus (itching) | 761 | 2.6 2.4–2.8ROR 2.7 · χ² 743 / p 8e-164 | 2.6 EB05 2.4 · IC025 +1.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 3.6 | NCT00502775: 1/229 (0.4%) control |
| Rash | 717 | 2.1 2.0–2.3ROR 2.2 · χ² 427 / p 3e-95 | 2.1 EB05 2.0 · IC025 +1.0 | No label text to screen label has no adverse-reaction text | serious PRR 2.9 | not reported in cached trials |
| Off label use (used outside approved label) | 713 | 1.0 1.0–1.1ROR 1.1 · χ² 2 / p 0.100 | 1.0 EB05 1.0 · IC025 -0.1 PRR-only: not supported by EBGM or IC | Reporting / coding artifact | serious PRR 0.9 | not reported in cached trials |
| Pain | 645 | 1.3 1.2–1.4ROR 1.4 · χ² 57 / p 3e-14 | 1.3 EB05 1.3 · IC025 +0.3 | No label text to screen label has no adverse-reaction text | serious PRR 1.3 | NCT00502775: 3/227 (1.3%) on Fexofenadine; 1/229 (0.4%) control |
| Urticaria (hives) | 619 | 4.8 4.4–5.1ROR 4.9 · χ² 1,844 / p <1e-300 | 4.7 EB05 4.4 · IC025 +2.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.0 | NCT00502775: 1/224 (0.4%) on Fexofenadine; 1/229 (0.4%) control |
| Malaise (feeling unwell) | 568 | 1.7 1.5–1.8ROR 1.7 · χ² 148 / p 2e-34 | 1.6 EB05 1.5 · IC025 +0.6 | No label text to screen label has no adverse-reaction text | serious PRR 1.8 | not reported in cached trials |
| Anxiety | 515 | 2.3 2.1–2.5ROR 2.3 · χ² 385 / p 6e-86 | 2.3 EB05 2.1 · IC025 +1.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 2.4 | not reported in cached trials |
| Arthralgia (joint pain) | 514 | 1.6 1.5–1.7ROR 1.6 · χ² 112 / p 2e-26 | 1.6 EB05 1.5 · IC025 +0.5 | No label text to screen label has no adverse-reaction text | serious PRR 1.8 | NCT00502775: 1/227 (0.4%) on Fexofenadine |
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, dyspnoea, headache, dizziness, diarrhoea. 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, 1,158 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.