What the label lists and what reports show
Apixaban side effects
Apixaban's FDA label: “Most common adverse reactions (>1%) in adult patients are related to bleeding.” FAERS holds 66,522 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 dyspnoea (3,794 reports).
- Generic approved
- Boxed warning
Check it at the source: the apixaban FDA label on DailyMed (effective April 24, 2026, Cardinal Health 107, LLC); 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 ELIQUIS?See “What is the most important information I should know about ELIQUIS?” The most common side effect of ELIQUIS in adults was bleeding. The most common side effect of ELIQUIS in children include: • headache • heavy menstrual bleeding • vomiting These are not all of the possible side effects of ELIQUIS. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. […] it may take longer than usual for any bleeding to stop Call your healthcare provider or get medical help right away if you or your child develop any of these signs or symptoms of bleeding during treatment with ELIQUIS: • unexpected bleeding or bruising, or bleeding that lasts a long time, such as: o unusual bleeding from the gums o nosebleeds that happen often o menstrual bleeding or vaginal bleeding that is heavier than normal • bleeding that is severe or you cannot control • red, pink, or brown urine • red or black stools (looks like tar) • cough up blood or blood clots • vomit blood or your vomit looks like “coffee grounds” • unexpected pain, swelling, or joint pain • headaches, feeling dizzy or weak • Spinal or epidural blood clots (hematoma).
Source: FDA drug label, NDA202155 (Bristol Myers Squibb), as published by Cardinal Health 107, LLC, effective April 24, 2026 (SPL set a454cd24-0c6d-46e8-b1e4-197388606175), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common adverse reactions (>1%) in adult patients are related to bleeding.
Table 2: Bleeding Events in Patients with Nonvalvular Atrial Fibrillation in ARISTOTLE*
| Reaction | ELIQUIS N=9088 n (per 100 pt-year) | Warfarin N=9052 n (per 100 pt-year) | Hazard Ratio (95% CI) | P-value |
|---|---|---|---|---|
| Major | 327 (2.13) | 462 (3.09) | 0.69 (0.60, 0.80) | <0.0001 |
| Intracranial (ICH) | 52 (0.33) | 125 (0.82) | 0.41 (0.30, 0.57) | - |
| Hemorrhagic stroke | 38 (0.24) | 74 (0.49) | 0.51 (0.34, 0.75) | - |
| Other ICH | 15 (0.10) | 51 (0.34) | 0.29 (0.16, 0.51) | - |
| Gastrointestinal (GI) | 128 (0.83) | 141 (0.93) | 0.89 (0.70, 1.14) | - |
| Fatal | 10 (0.06) | 37 (0.24) | 0.27 (0.13, 0.53) | - |
| Intracranial | 4 (0.03) | 30 (0.20) | 0.13 (0.05, 0.37) | - |
| Non-intracranial | 6 (0.04) | 7 (0.05) | 0.84 (0.28, 2.15) | - |
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 Thrombotic Events After Premature Discontinuation [see Warnings and Precautions (5.1) ] • Bleeding [see Warnings and Precautions (5.2) ] • Spinal/Epidural Anesthesia or Puncture [see Warnings and Precautions (5.3) ] • Most common adverse reactions (>1%) in adult patients are related to bleeding. (6.1) • The most common adverse reactions (≥10%) in pediatric patients were headache, vomiting, and excessive menstrual bleeding. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Bristol-Myers Squibb at 1-800-721-5072 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Adult Patients 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. Reduction of Risk of Stroke and Systemic Embolism in Patients with Nonvalvular Atrial Fibrillation The safety of ELIQUIS was evaluated in the ARISTOTLE and AVERROES studies [see Clinical Studies (14) ], including 11,284 patients exposed to ELIQUIS 5 mg twice daily and 602 patients exposed to ELIQUIS 2.5 mg twice daily. …
Source: FDA drug label, NDA202155 (Bristol Myers Squibb), as published by Cardinal Health 107, LLC, effective April 24, 2026 (SPL set a454cd24-0c6d-46e8-b1e4-197388606175), via openFDA; the full label on DailyMed
What do FAERS reports show?
66,522 reports list apixaban among the medicines taken, each a report of something that happened, not proof the medicine caused it; 7,220 are coded as a death and 29,310 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. Of the 18 reactions below, 7 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?
- Apixaban: 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