What the label lists and what reports show
Edoxaban side effects
Edoxaban's FDA label: “The most common adverse reactions (≥ 5%) are bleeding and anemia ( 6.1 ) Treatment of DVT and PE : The most common adverse reactions (≥ 1%) are bleeding, rash, abnormal liver function tests and anemia ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact …” FAERS holds 6,591 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is anaemia (313 reports).
- No generic listed
- Boxed warning
Check it at the source: the edoxaban FDA label on DailyMed (effective July 10, 2025, Daiichi Sankyo Inc.); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of SAVAYSA?SAVAYSA can cause serious side effects. See " What is the most important information I should know about SAVAYSA? " The most common side effects in people who take SAVAYSA for nonvalvular atrial fibrillation include bleeding and low red blood cell count (anemia). The most common side effects in people who take SAVAYSA for deep vein thrombosis and pulmonary embolism include bleeding, rash, abnormal liver function tests, and low red blood cell count (anemia). Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Source: FDA drug label, Daiichi Sankyo Inc., effective July 10, 2025 (SPL set e77d3400-56ad-11e3-949a-0800200c9a66), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe most common adverse reactions (≥ 5%) are bleeding and anemia ( 6.1 ) Treatment of DVT and PE : The most common adverse reactions (≥ 1%) are bleeding, rash, abnormal liver function tests and anemia ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Daiichi Sankyo, Inc.
Table 6.5: Bleeding Events in the Hokusai VTE Cancer Study
| Reaction | SAVAYSA (N = 522) | Dalteparin (N = 524) |
|---|---|---|
| Major Bleeding A major bleeding event was defined as clinically overt bleeding that met… | 32 (6.1%) | 16 (3.1%) |
| Intracranial | 0 | 1 (0.2%) |
| Lower gastrointestinal | 1 (0.2%) | 1 (0.2%) |
| Non-fatal critical organ bleeding | 5 (1%) | 6 (1.1%) |
| Intracranial bleeding | 2 (0.4%) | 2 (0.4%) |
| Non-fatal non-critical organ bleeding | 27 (5.2%) | 8 (1.5%) |
| Gastrointestinal | 22 (4.2%) | 4 (0.8%) |
| Upper gastrointestinal | 18 (3.4%) | 3 (0.6%) |
| Lower gastrointestinal | 3 (0.6%) | 1 (0.2%) |
| Decrease in Hb ≥ 2 g/dL | 28 (5.4%) | 11 (2.1%) |
| CRNM Bleeding CRNM bleeding was defined as overt bleeding not meeting the criteria for a… | 70 (13.4%) | 48 (9.2%) |
| Any Bleeding, n (%) | 137 (26.2%) | 104 (19.8%) |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe following clinically significant adverse reactions are discussed in greater detail in other sections of the prescribing information. Increased Risk of Stroke with Discontinuation of SAVAYSA in Patients with Nonvalvular Atrial Fibrillation [see Warnings and Precautions (5.2) ] Risk of Bleeding [see Warnings and Precautions (5.3) ] Spinal/Epidural Anesthesia or Puncture [see Warnings and Precautions (5.4) ] Treatment of NVAF : The most common adverse reactions (≥ 5%) are bleeding and anemia ( 6.1 ) Treatment of DVT and PE : The most common adverse reactions (≥ 1%) are bleeding, rash, abnormal liver function tests and anemia ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Daiichi Sankyo, Inc. at 1-877-437-7763 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of SAVAYSA was evaluated in the ENGAGE AF-TIMI 48, Hokusai VTE, and Hokusai VTE Cancer studies including 11,530 patients exposed to SAVAYSA 60 mg and 7124 patients exposed to SAVAYSA 30 mg once daily [see Clinical Studies (14) ]. …
Source: FDA drug label, Daiichi Sankyo Inc., effective July 10, 2025 (SPL set e77d3400-56ad-11e3-949a-0800200c9a66), via openFDA; the full label on DailyMed
What do FAERS reports show?
6,591 reports list edoxaban among the medicines taken, each a report of something that happened, not proof the medicine caused it; 873 are coded as a death and 3,493 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Reports rose sharply in 2024 (1,188, against a median of 253 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens. Of the 21 reactions below, 5 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Edoxaban: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions