Drug · FAERS side-effect profile with label screen
Edoxaban Tosylate side effects: what 6,590 FDA adverse event reports show
Drug class
Factor xa inhibitor
FDA label, Indications wording
Brand names
Savaysa
openFDA label
Who reports
6,590 reports · 90% serious · 873 with death outcome · 48% female
openFDA FAERS counts, all years, deduplication not applied
Used for
SAVAYSA is a factor Xa inhibitor indicated: To reduce the risk of stroke and systemic embolism (SE) in patients with nonvalvular atrial fibrillation (NVAF) ( 1.1 ) Limitation of Use for NVAF SAVAYSA should not be used in patients with creatinine cleara.
FDA label, Indications and Usage
What it is
Edoxaban, a factor Xa inhibitor, is supplied as edoxaban tosylate monohydrate.
FDA label, Description section
Boxed warning
(A) REDUCED EFFICACY IN NONVALVULAR ATRIAL FIBRILLATION PATIENTS WITH CREATININE CLEARANCE (CRCL) > 95 ML/MIN (B) PREMATURE DISCONTINUATION OF SAVAYSA INCREASES THE RISK OF ISCHEMIC EVENTS (C) SPINAL/EPIDURAL HEMATOM.
FDA 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 — boxed warning 3Labeled adverse reaction 5Labeled (related wording) 4Reporting / coding artifact 1Lab value / disease marker 2Not in label — unassessed 25
What the badges mean
- Labeled — boxed warning The term (or its clinical synonym) appears in the FDA boxed warning: causality is regulator-recognised and considered serious.
- Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
- 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. 268 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 |
|---|---|---|---|---|---|---|
| Cerebral infarction | 262 | 34.4 30.6–38.8ROR 35.8 · χ² 8,392 / p <1e-300 | 34.0 EB05 30.7 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious PRR 21.8 · 98% clinician | no trial data cached |
| Mitral valve incompetence | 53 | 15.0 11.4–19.6ROR 15.1 · χ² 674 / p 7e-149 | 14.8 EB05 11.6 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 9.6 · ♀ 80% (drug 48%) · 94% clinician | no trial data cached |
| Melaena (black stool) | 96 | 13.9 11.4–17.0ROR 14.1 · χ² 1,133 / p 1e-248 | 13.8 EB05 11.6 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 9.0 · 96% clinician | no trial data cached |
| Haematuria (blood in urine) | 147 | 13.7 11.7–16.1ROR 14.0 · χ² 1,712 / p <1e-300 | 13.6 EB05 11.8 · IC025 +3.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 8.2 | no trial data cached |
| Renal impairment | 286 | 10.9 9.7–12.2ROR 11.4 · χ² 2,565 / p <1e-300 | 10.8 EB05 9.8 · IC025 +3.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 7.2 | no trial data cached |
| Brain oedema | 42 | 10.6 7.8–14.4ROR 10.7 · χ² 355 / p 2e-79 | 10.1 EB05 7.7 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 6.7 · ♀ 92% (drug 48%) | no trial data cached |
| Cardiac failure (heart failure) | 260 | 10.3 9.2–11.6ROR 10.7 · χ² 2,182 / p <1e-300 | 10.2 EB05 9.2 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 6.6 · 92% clinician | no trial data cached |
| Pneumonia aspiration | 75 | 9.6 7.7–12.0ROR 9.7 · χ² 568 / p 7e-126 | 9.3 EB05 7.6 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 6.2 · 100% clinician | no trial data cached |
| Joint dislocation | 30 | 9.1 6.4–13.0ROR 9.1 · χ² 207 / p 3e-47 | 8.4 EB05 6.0 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 6.6 · ♀ 100% (drug 48%) · 97% clinician | no trial data cached |
| Glomerular filtration rate decreased | 34 | 9.0 6.4–12.5ROR 9.0 · χ² 232 / p 1e-52 | 8.3 EB05 6.1 · IC025 +2.4 3/3 methods agree | Lab value / disease marker | serious PRR 6.9 · 94% clinician | no trial data cached |
| Subdural haematoma | 40 | 8.9 6.5–12.1ROR 8.9 · χ² 271 / p 3e-61 | 8.3 EB05 6.3 · IC025 +2.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.7 · 100% clinician | no trial data cached |
| Subarachnoid haemorrhage | 28 | 8.7 6.0–12.7ROR 8.8 · χ² 184 / p 3e-42 | 8.0 EB05 5.7 · IC025 +2.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.6 · 93% clinician | no trial data cached |
| Metastases to central nervous system | 34 | 8.5 6.1–11.8ROR 8.5 · χ² 216 / p 3e-49 | 7.8 EB05 5.8 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 5.5 · ♀ 94% (drug 48%) · 91% clinician | no trial data cached |
| Upper gastrointestinal haemorrhage | 44 | 8.3 6.2–11.2ROR 8.4 · χ² 275 / p 4e-62 | 7.8 EB05 6.0 · IC025 +2.4 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.2 · 95% clinician | no trial data cached |
| Pulmonary hypertension | 54 | 8.2 6.3–10.7ROR 8.3 · χ² 335 / p 3e-75 | 7.8 EB05 6.2 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 5.3 · ♀ 86% (drug 48%) | no trial data cached |
| Cerebral haemorrhage | 90 | 8.0 6.5–9.9ROR 8.1 · χ² 546 / p 5e-121 | 7.8 EB05 6.5 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 5.2 · 93% clinician | no trial data cached |
| Interstitial lung disease | 120 | 7.9 6.6–9.5ROR 8.0 · χ² 718 / p 2e-158 | 7.7 EB05 6.6 · IC025 +2.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.1 · 95% clinician | no trial data cached |
| Myelodysplastic syndrome | 35 | 7.7 5.5–10.7ROR 7.7 · χ² 197 / p 4e-45 | 7.1 EB05 5.3 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 5.0 · ♀ 84% (drug 48%) · 97% clinician | no trial data cached |
| Iron deficiency anaemia | 22 | 7.6 5.0–11.6ROR 7.7 · χ² 120 / p 3e-28 | 6.8 EB05 4.6 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 5.0 · ♀ 70% (drug 48%) | no trial data cached |
| Gastrointestinal haemorrhage | 195 | 7.4 6.4–8.5ROR 7.6 · χ² 1,073 / p 1e-235 | 7.3 EB05 6.5 · IC025 +2.6 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.2 · 91% clinician | no trial data cached |
| Cardiogenic shock | 32 | 7.1 5.1–10.1ROR 7.2 · χ² 163 / p 1e-37 | 6.6 EB05 4.8 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 4.6 · ♀ 86% (drug 48%) · 97% clinician | no trial data cached |
| Hiatus hernia | 29 | 7.1 5.0–10.2ROR 7.2 · χ² 146 / p 5e-34 | 6.5 EB05 4.7 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 5.2 · ♀ 100% (drug 48%) · 93% clinician | no trial data cached |
| Presyncope (near-fainting) | 53 | 7.0 5.3–9.1ROR 7.0 · χ² 265 / p 6e-60 | 6.6 EB05 5.2 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 5.7 · ♀ 25% (drug 48%) · 96% clinician | no trial data cached |
| Atrial fibrillation | 210 | 6.9 6.0–7.8ROR 7.1 · χ² 1,048 / p 3e-230 | 6.8 EB05 6.0 · IC025 +2.5 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 4.5 | no trial data cached |
| Candida infection (yeast infection) | 35 | 6.7 4.8–9.3ROR 6.7 · χ² 163 / p 1e-37 | 6.2 EB05 4.6 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 5.6 · ♀ 100% (drug 48%) | no trial data cached |
| Ischaemic stroke | 37 | 6.6 4.8–9.1ROR 6.6 · χ² 170 / p 4e-39 | 6.1 EB05 4.6 · IC025 +2.1 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 4.1 | no trial data cached |
| Cardiomegaly | 25 | 6.4 4.3–9.5ROR 6.4 · χ² 109 / p 8e-26 | 5.8 EB05 4.1 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 4.2 · ♀ 27% (drug 48%) · 92% clinician | no trial data cached |
| Polyneuropathy | 23 | 6.2 4.1–9.3ROR 6.2 · χ² 94 / p 1e-22 | 5.5 EB05 3.9 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 3.7 · ♀ 75% (drug 48%) · 100% clinician | no trial data cached |
| Faeces discoloured | 40 | 5.9 4.3–8.0ROR 5.9 · χ² 157 / p 3e-36 | 5.5 EB05 4.2 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 4.7 | no trial data cached |
| Osteopenia | 28 | 5.8 4.0–8.5ROR 5.9 · χ² 108 / p 2e-25 | 5.4 EB05 3.9 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 4.4 · ♀ 100% (drug 48%) · 96% clinician | no trial data cached |
| Gingival bleeding | 25 | 5.8 3.9–8.6ROR 5.8 · χ² 95 / p 9e-23 | 5.3 EB05 3.8 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 4.0 | no trial data cached |
| C-reactive protein increased | 66 | 5.8 4.5–7.4ROR 5.8 · χ² 256 / p 6e-58 | 5.6 EB05 4.5 · IC025 +2.1 3/3 methods agree | Lab value / disease marker | serious PRR 3.7 · ♀ 75% (drug 48%) | no trial data cached |
| Sopor | 24 | 5.7 3.8–8.5ROR 5.7 · χ² 89 / p 2e-21 | 5.2 EB05 3.7 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 3.7 · ♀ 71% (drug 48%) · 100% clinician | no trial data cached |
| Skin fissures | 33 | 5.6 4.0–7.8ROR 5.6 · χ² 119 / p 5e-28 | 5.2 EB05 3.9 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious n=33 · ♀ 84% (drug 48%) | no trial data cached |
| Post procedural haemorrhage | 20 | 5.5 3.5–8.5ROR 5.5 · χ² 68 / p 7e-17 | 4.9 EB05 3.3 · IC025 +1.5 3/3 methods agree | Reporting / coding artifact | serious PRR 3.7 | no trial data cached |
| Drug eruption | 30 | 5.4 3.8–7.8ROR 5.4 · χ² 104 / p 1e-24 | 5.0 EB05 3.7 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 3.9 · 93% clinician | no trial data cached |
| Epistaxis (nosebleed) | 127 | 5.4 4.5–6.4ROR 5.5 · χ² 452 / p 2e-100 | 5.3 EB05 4.6 · IC025 +2.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.4 | no trial data cached |
| Haematoma | 44 | 5.4 4.0–7.2ROR 5.4 · χ² 153 / p 2e-35 | 5.1 EB05 4.0 · IC025 +1.9 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 3.4 | no trial data cached |
| Eructation (belching) | 32 | 5.4 3.8–7.6ROR 5.4 · χ² 109 / p 8e-26 | 5.0 EB05 3.7 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious n=32 · ♀ 100% (drug 48%) · 94% clinician | no trial data cached |
| Anaemia (low red blood cells) | 313 | 5.2 4.7–5.8ROR 5.4 · χ² 1,073 / p 1e-235 | 5.2 EB05 4.7 · IC025 +2.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.6 · 95% clinician | 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 |
|---|---|---|---|---|---|---|
| Anaemia (low red blood cells) | 313 | 5.2 4.7–5.8ROR 5.4 · χ² 1,073 / p 1e-235 | 5.2 EB05 4.7 · IC025 +2.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.6 · 95% clinician | no trial data cached |
| Renal impairment | 286 | 10.9 9.7–12.2ROR 11.4 · χ² 2,565 / p <1e-300 | 10.8 EB05 9.8 · IC025 +3.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 7.2 | no trial data cached |
| Cerebral infarction | 262 | 34.4 30.6–38.8ROR 35.8 · χ² 8,392 / p <1e-300 | 34.0 EB05 30.7 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious PRR 21.8 · 98% clinician | no trial data cached |
| Cardiac failure (heart failure) | 260 | 10.3 9.2–11.6ROR 10.7 · χ² 2,182 / p <1e-300 | 10.2 EB05 9.2 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 6.6 · 92% clinician | no trial data cached |
| Pneumonia (lung infection) | 212 | 2.1 1.8–2.4ROR 2.1 · χ² 121 / p 2e-28 | 2.1 EB05 1.9 · IC025 +0.8 | Labeled adverse reaction exact term | serious PRR 1.4 | no trial data cached |
| Atrial fibrillation | 210 | 6.9 6.0–7.8ROR 7.1 · χ² 1,048 / p 3e-230 | 6.8 EB05 6.0 · IC025 +2.5 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 4.5 | no trial data cached |
| Fall | 206 | 2.0 1.7–2.3ROR 2.0 · χ² 99 / p 1e-23 | 2.0 EB05 1.8 · IC025 +0.7 | Labeled adverse reaction exact term | serious PRR 1.5 | no trial data cached |
| Gastrointestinal haemorrhage | 195 | 7.4 6.4–8.5ROR 7.6 · χ² 1,073 / p 1e-235 | 7.3 EB05 6.5 · IC025 +2.6 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.2 · 91% clinician | no trial data cached |
| Acute kidney injury (sudden kidney damage) | 189 | 4.0 3.4–4.5ROR 4.0 · χ² 416 / p 8e-93 | 3.9 EB05 3.5 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 2.5 · 97% clinician | no trial data cached |
| Decreased appetite (loss of appetite) | 170 | 2.3 2.0–2.7ROR 2.4 · χ² 130 / p 2e-30 | 2.3 EB05 2.0 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 2.2 | no trial data cached |
| Haematuria (blood in urine) | 147 | 13.7 11.7–16.1ROR 14.0 · χ² 1,712 / p <1e-300 | 13.6 EB05 11.8 · IC025 +3.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 8.2 | no trial data cached |
| Drug interaction | 145 | 2.9 2.5–3.4ROR 3.0 · χ² 181 / p 1e-41 | 2.9 EB05 2.5 · IC025 +1.3 3/3 methods agree | Reporting / coding artifact | serious PRR 2.0 | no trial data cached |
| Hypotension (low blood pressure) | 143 | 2.3 1.9–2.7ROR 2.3 · χ² 102 / p 4e-24 | 2.3 EB05 2.0 · IC025 +0.9 | Not in label — unassessed | serious PRR 1.6 | no trial data cached |
| General physical health deterioration | 141 | 3.9 3.3–4.6ROR 4.0 · χ² 304 / p 3e-68 | 3.9 EB05 3.4 · IC025 +1.7 3/3 methods agree | Reporting / coding artifact | serious PRR 2.9 | no trial data cached |
| Dehydration | 131 | 3.1 2.6–3.7ROR 3.2 · χ² 188 / p 4e-43 | 3.1 EB05 2.7 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 2.3 | 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.
- Cerebral infarction — n=262, PRR 34.4
- Mitral valve incompetence — n=53, PRR 15.0
- Melaena — n=96, PRR 13.9
- Brain oedema — n=42, PRR 10.6
- Cardiac failure — n=260, PRR 10.3
- Pneumonia aspiration — n=75, PRR 9.6
- Joint dislocation — n=30, PRR 9.1
- Metastases to central nervous system — n=34, PRR 8.5
- Pulmonary hypertension — n=54, PRR 8.2
- Cerebral haemorrhage — n=90, PRR 8.0
✓ A hand-written Bradford Hill causality assessment exists for this drug: Edoxaban ↔ Gastrointestinal haemorrhage.
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 Edoxaban Tosylate?
In FDA FAERS, the most frequently co-reported reaction terms for Edoxaban Tosylate are anaemia, renal impairment, cerebral infarction, cardiac failure, pneumonia, atrial fibrillation. 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 Edoxaban Tosylate have an FDA boxed warning?
Yes. The current FDA label carries a boxed warning: (A) REDUCED EFFICACY IN NONVALVULAR ATRIAL FIBRILLATION PATIENTS WITH CREATININE CLEARANCE (CRCL) > 95 ML/MIN (B) PREMATURE DISCONTINUATION OF SAVAYSA INCREASES THE RISK OF ISCHEMIC EVENTS (C) SPINAL/EPIDURAL HEMATOM.
Do FAERS signals prove that Edoxaban Tosylate 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 e77d3400-56ad-11e3-949a-0800200c9a66, effective 20250710; matched on
openfda.generic_name.exact:"EDOXABAN TOSYLATE") - 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, 308 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.