Drug · FAERS side-effect profile with label screen
Fexofenadine Hydrochloride Oral side effects: what 5,871 FDA adverse event reports show
Drug class
Not stated in label
Who reports
5,871 reports · 71% serious · 406 with death outcome · 62% 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 2No label text to screen 37
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. 490 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 |
|---|---|---|---|---|---|---|
| Seasonal allergy | 49 | 12.4 9.4–16.4ROR 12.5 · χ² 502 / p 2e-111 | 12.1 EB05 9.4 · IC025 +3.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=30 · 73% consumer | no trial data cached |
| Drug eruption | 54 | 11.0 8.4–14.3ROR 11.1 · χ² 478 / p 3e-106 | 10.6 EB05 8.3 · IC025 +2.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 9.7 | no trial data cached |
| Infusion site pain | 37 | 10.4 7.5–14.3ROR 10.4 · χ² 303 / p 3e-68 | 9.8 EB05 7.3 · IC025 +2.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=24 · ♀ 84% (drug 62%) · 73% consumer | no trial data cached |
| Dermatitis contact | 30 | 9.5 6.6–13.5ROR 9.5 · χ² 218 / p 1e-49 | 8.7 EB05 6.3 · IC025 +2.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=20 · ♀ 89% (drug 62%) · 82% consumer | no trial data cached |
| Dizziness postural | 21 | 7.8 5.1–12.0ROR 7.8 · χ² 118 / p 9e-28 | 6.9 EB05 4.7 · IC025 +2.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=13 · ♀ 85% (drug 62%) | no trial data cached |
| Hepatic function abnormal | 76 | 7.3 5.9–9.2ROR 7.4 · χ² 409 / p 3e-91 | 7.1 EB05 5.8 · IC025 +2.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.2 · ♀ 37% (drug 62%) · 95% clinician | no trial data cached |
| Erythema multiforme | 19 | 7.3 4.6–11.4ROR 7.3 · χ² 97 / p 4e-23 | 6.3 EB05 4.2 · IC025 +1.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.5 | no trial data cached |
| Brain fog | 28 | 6.9 4.7–9.9ROR 6.9 · χ² 134 / p 2e-31 | 6.2 EB05 4.5 · IC025 +2.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.3 · ♀ 88% (drug 62%) · 82% consumer | no trial data cached |
| Skin infection | 20 | 6.4 4.1–9.9ROR 6.4 · χ² 86 / p 1e-20 | 5.7 EB05 3.8 · IC025 +1.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.5 · 70% consumer | no trial data cached |
| Interstitial lung disease | 84 | 6.2 5.0–7.7ROR 6.3 · χ² 363 / p 4e-81 | 6.0 EB05 5.0 · IC025 +2.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.1 · ♀ 32% (drug 62%) · 94% clinician | no trial data cached |
| Pharyngeal swelling | 16 | 6.0 3.7–9.7ROR 6.0 · χ² 61 / p 2e-15 | 5.2 EB05 3.4 · IC025 +1.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=12 | no trial data cached |
| Altered state of consciousness | 36 | 6.0 4.3–8.3ROR 6.0 · χ² 144 / p 2e-33 | 5.6 EB05 4.2 · IC025 +1.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.9 | no trial data cached |
| Hereditary angioedema | 17 | 5.8 3.6–9.3ROR 5.8 · χ² 63 / p 1e-15 | 5.1 EB05 3.3 · IC025 +1.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.6 | no trial data cached |
| Adrenal insufficiency | 19 | 5.7 3.6–8.9ROR 5.7 · χ² 68 / p 6e-17 | 5.0 EB05 3.4 · IC025 +1.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.7 | no trial data cached |
| Schizophrenia | 19 | 5.6 3.6–8.8ROR 5.6 · χ² 67 / p 1e-16 | 5.0 EB05 3.4 · IC025 +1.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.2 | no trial data cached |
| Euphoric mood | 16 | 5.5 3.4–9.1ROR 5.6 · χ² 55 / p 6e-14 | 4.8 EB05 3.2 · IC025 +1.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=15 | no trial data cached |
| Poor venous access | 16 | 5.5 3.4–9.0ROR 5.6 · χ² 55 / p 6e-14 | 4.8 EB05 3.2 · IC025 +1.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=14 | no trial data cached |
| Insurance issue | 23 | 5.5 3.7–8.3ROR 5.6 · χ² 81 / p 1e-19 | 5.0 EB05 3.5 · IC025 +1.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 8.9 · ♀ 100% (drug 62%) · 74% consumer | no trial data cached |
| Product use complaint | 22 | 5.1 3.3–7.7ROR 5.1 · χ² 68 / p 9e-17 | 4.6 EB05 3.2 · IC025 +1.5 3/3 methods agree | Reporting / coding artifact | serious n=12 · ♀ 38% (drug 62%) | no trial data cached |
| Pneumonia aspiration | 34 | 4.9 3.5–6.8ROR 4.9 · χ² 101 / p 5e-24 | 4.6 EB05 3.4 · IC025 +1.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.0 · ♀ 29% (drug 62%) · 91% clinician | no trial data cached |
| Basal cell carcinoma | 21 | 4.8 3.1–7.4ROR 4.8 · χ² 59 / p 6e-15 | 4.4 EB05 3.0 · IC025 +1.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.0 | no trial data cached |
| Vitamin d deficiency | 13 | 4.8 2.8–8.2ROR 4.8 · χ² 35 / p 2e-9 | 4.1 EB05 2.6 · IC025 +1.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.0 | no trial data cached |
| Cerebral infarction | 31 | 4.5 3.2–6.4ROR 4.5 · χ² 82 / p 8e-20 | 4.3 EB05 3.1 · IC025 +1.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 3.7 · ♀ 41% (drug 62%) · 90% clinician | no trial data cached |
| Anaphylactic reaction (severe allergic reaction) | 67 | 4.4 3.4–5.5ROR 4.4 · χ² 170 / p 3e-39 | 4.2 EB05 3.5 · IC025 +1.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 3.6 | no trial data cached |
| Ligament sprain | 12 | 4.3 2.5–7.6ROR 4.4 · χ² 28 / p 7e-8 | 3.8 EB05 2.3 · IC025 +1.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=10 | no trial data cached |
| Neuralgia | 29 | 4.3 3.0–6.1ROR 4.3 · χ² 69 / p 4e-17 | 4.0 EB05 2.9 · IC025 +1.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.0 | no trial data cached |
| Upper respiratory tract infection (cold/sinus infection) | 55 | 4.3 3.3–5.5ROR 4.3 · χ² 134 / p 3e-31 | 4.1 EB05 3.3 · IC025 +1.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.6 | no trial data cached |
| Neutrophil count decreased | 48 | 4.2 3.2–5.6ROR 4.3 · χ² 115 / p 3e-27 | 4.1 EB05 3.2 · IC025 +1.6 3/3 methods agree | Lab value / disease marker | serious PRR 3.7 · 94% clinician | no trial data cached |
| Skin haemorrhage | 17 | 4.2 2.6–6.8ROR 4.2 · χ² 38 / p 3e-10 | 3.8 EB05 2.5 · IC025 +1.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=9 | no trial data cached |
| Hyperlipidaemia | 14 | 4.2 2.5–7.0ROR 4.2 · χ² 31 / p 2e-8 | 3.7 EB05 2.4 · IC025 +1.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 3.7 | no trial data cached |
| Sinus disorder | 23 | 4.1 2.8–6.2ROR 4.2 · χ² 52 / p 3e-13 | 3.9 EB05 2.7 · IC025 +1.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.1 | no trial data cached |
| Lymphadenopathy | 41 | 4.1 3.0–5.6ROR 4.2 · χ² 94 / p 1e-22 | 4.0 EB05 3.0 · IC025 +1.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.1 · ♀ 83% (drug 62%) | no trial data cached |
| Nightmare | 40 | 4.1 3.0–5.6ROR 4.1 · χ² 91 / p 7e-22 | 3.9 EB05 3.0 · IC025 +1.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.4 · ♀ 89% (drug 62%) · 80% consumer | no trial data cached |
| Hypercholesterolaemia | 11 | 4.1 2.3–7.4ROR 4.1 · χ² 23 / p 9e-7 | 3.6 EB05 2.2 · IC025 +0.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 3.5 | no trial data cached |
| Lymphocyte count decreased | 20 | 4.0 2.6–6.3ROR 4.1 · χ² 43 / p 3e-11 | 3.7 EB05 2.6 · IC025 +1.2 3/3 methods agree | Lab value / disease marker | serious PRR 3.8 | no trial data cached |
| Bronchospasm (airway tightening) | 16 | 4.0 2.4–6.5ROR 4.0 · χ² 33 / p 5e-9 | 3.6 EB05 2.4 · IC025 +1.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 2.7 | no trial data cached |
| Sensory disturbance | 18 | 4.0 2.5–6.3ROR 4.0 · χ² 37 / p 5e-10 | 3.7 EB05 2.5 · IC025 +1.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.4 | no trial data cached |
| Sexual dysfunction | 13 | 4.0 2.3–6.8ROR 4.0 · χ² 26 / p 2e-7 | 3.5 EB05 2.2 · IC025 +0.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.8 | no trial data cached |
| Extra dose administered | 44 | 3.9 2.9–5.3ROR 4.0 · χ² 94 / p 2e-22 | 3.8 EB05 2.9 · IC025 +1.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=5 · 100% consumer | no trial data cached |
| Ear infection | 29 | 3.9 2.7–5.6ROR 3.9 · χ² 60 / p 5e-15 | 3.7 EB05 2.7 · IC025 +1.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.8 · ♀ 89% (drug 62%) | 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 |
|---|---|---|---|---|---|---|
| Headache | 325 | 1.9 1.7–2.1ROR 1.9 · χ² 131 / p 1e-30 | 1.9 EB05 1.7 · IC025 +0.7 | No label text to screen label has no adverse-reaction text | serious PRR 2.2 | no trial data cached |
| Diarrhoea (diarrhea) | 323 | 1.8 1.6–2.0ROR 1.8 · χ² 116 / p 2e-27 | 1.8 EB05 1.6 · IC025 +0.7 | No label text to screen label has no adverse-reaction text | serious PRR 2.0 | no trial data cached |
| Pruritus (itching) | 295 | 2.8 2.5–3.1ROR 2.9 · χ² 342 / p 1e-76 | 2.8 EB05 2.5 · IC025 +1.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 3.9 | no trial data cached |
| Dizziness | 279 | 2.0 1.8–2.2ROR 2.1 · χ² 142 / p 5e-33 | 2.0 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 |
| Rash | 256 | 2.1 1.9–2.4ROR 2.2 · χ² 151 / p 5e-35 | 2.1 EB05 1.9 · IC025 +0.9 | No label text to screen label has no adverse-reaction text | serious PRR 2.7 | no trial data cached |
| Pyrexia (fever) | 210 | 2.2 1.9–2.5ROR 2.2 · χ² 133 / p 5e-31 | 2.2 EB05 1.9 · IC025 +0.9 | No label text to screen label has no adverse-reaction text | serious PRR 2.0 | no trial data cached |
| Malaise (feeling unwell) | 200 | 1.6 1.4–1.9ROR 1.6 · χ² 48 / p 2e-12 | 1.6 EB05 1.4 · IC025 +0.5 | No label text to screen label has no adverse-reaction text | serious PRR 1.7 | no trial data cached |
| Pneumonia (lung infection) | 194 | 2.1 1.9–2.5ROR 2.2 · χ² 119 / p 5e-28 | 2.1 EB05 1.9 · IC025 +0.9 | No label text to screen label has no adverse-reaction text | serious PRR 1.8 | no trial data cached |
| Cough | 182 | 2.3 2.0–2.7ROR 2.4 · χ² 138 / p 5e-32 | 2.3 EB05 2.0 · IC025 +1.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 2.0 | no trial data cached |
| Insomnia (trouble sleeping) | 175 | 2.3 2.0–2.7ROR 2.4 · χ² 135 / p 2e-31 | 2.3 EB05 2.1 · IC025 +1.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 3.0 | no trial data cached |
| Condition aggravated | 162 | 1.9 1.6–2.2ROR 1.9 · χ² 71 / p 2e-17 | 1.9 EB05 1.7 · IC025 +0.7 | Reporting / coding artifact | serious PRR 1.7 | no trial data cached |
| Arthralgia (joint pain) | 155 | 1.3 1.1–1.6ROR 1.3 · χ² 13 / p 2e-4 | 1.3 EB05 1.2 · IC025 +0.2 | No label text to screen label has no adverse-reaction text | serious PRR 1.5 | no trial data cached |
| Anxiety | 153 | 1.9 1.6–2.2ROR 1.9 · χ² 67 / p 1e-16 | 1.9 EB05 1.7 · IC025 +0.7 | No label text to screen label has no adverse-reaction text | serious PRR 2.0 | no trial data cached |
| Urticaria (hives) | 139 | 3.0 2.5–3.5ROR 3.0 · χ² 183 / p 7e-42 | 3.0 EB05 2.6 · IC025 +1.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 3.5 | no trial data cached |
| Erythema (skin redness) | 131 | 2.3 1.9–2.7ROR 2.3 · χ² 94 / p 2e-22 | 2.3 EB05 2.0 · IC025 +0.9 | No label text to screen label has no adverse-reaction text | serious PRR 3.3 | 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.
✓ A hand-written Bradford Hill causality assessment exists for this drug: Minoxidil (oral) ↔ Pericardial effusion.
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, diarrhoea, pruritus, dizziness, rash, pyrexia. 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, 530 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.