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Can ELIQUIS cause hematuria? Understanding the Risks and What to Do

4 min read

According to the FDA drug label, hematuria (blood in the urine) is a possible adverse reaction to ELIQUIS (apixaban), occurring in some patients [1.2.1]. The central question for many is, can ELIQUIS cause hematuria, and what does it mean for your health?

Quick Summary

ELIQUIS, an anticoagulant, works by preventing blood clots but increases bleeding risk. Hematuria, or blood in the urine, is a recognized side effect, though it may also signal an underlying urological issue.

Key Points

  • Direct Side Effect: Yes, ELIQUIS (apixaban) can cause hematuria (blood in urine) as it is an anticoagulant that increases the risk of bleeding [1.2.1, 1.2.2].

  • Mechanism of Action: ELIQUIS works by inhibiting Factor Xa, a key factor in the blood clotting process, which lowers the risk of stroke but inherently increases bleeding potential [1.3.2, 1.3.4].

  • Underlying Issues: Hematuria while on ELIQUIS may unmask a pre-existing but previously asymptomatic urological condition, such as stones or tumors [1.4.4].

  • Increased Risk Factors: The risk of hematuria is higher in patients with kidney impairment, advanced age, low body weight, or those taking other medications like NSAIDs or aspirin [1.9.1, 1.6.3].

  • Medical Attention is Crucial: Never ignore blood in your urine. Contact your doctor immediately but do not stop taking ELIQUIS unless instructed, to avoid the risk of clots or stroke [1.4.1, 1.6.3].

  • Comparative Safety: Clinical studies suggest ELIQUIS has a lower risk of major bleeding, including hematuria, compared to other anticoagulants like Xarelto (rivaroxaban) and warfarin [1.5.1, 1.5.3].

  • Management: If hematuria occurs, a doctor will investigate the cause, which may involve pausing the medication, adjusting the dose, or performing a urological evaluation [1.4.2].

In This Article

What is ELIQUIS (Apixaban) and How Does It Work?

ELIQUIS, with the generic name apixaban, is an oral anticoagulant medication prescribed to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation (AFib) [1.3.3]. It is also used to treat and prevent deep vein thrombosis (DVT) and pulmonary embolism (PE) [1.6.3]. Apixaban is a direct, reversible, and highly selective inhibitor of Factor Xa, a critical component in the blood clotting cascade [1.3.4]. By blocking Factor Xa, ELIQUIS effectively decreases thrombin generation, which in turn reduces the formation of fibrin clots [1.3.2]. Unlike older anticoagulants like warfarin, ELIQUIS has predictable pharmacokinetics and fewer drug and food interactions, reaching its full therapeutic effect within hours [1.3.1].

The Inherent Risk of Bleeding

Because ELIQUIS is a blood thinner, its primary therapeutic action of preventing clots also carries an inherent risk of bleeding [1.8.1]. This can range from minor issues like bruising more easily or occasional nosebleeds to serious, potentially fatal bleeding events [1.6.4, 1.8.2]. The manufacturer explicitly warns that ELIQUIS increases the risk of bleeding [1.8.5]. This risk is amplified when taken with other medications that affect hemostasis, such as aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs), and other anticoagulants [1.6.3, 1.8.5].

Understanding Hematuria: Blood in the Urine

Hematuria is the medical term for the presence of red blood cells in the urine [1.7.5]. It can be categorized into two types:

  • Gross Hematuria: The blood is visible to the naked eye, causing urine to appear pink, red, or cola-colored [1.7.4].
  • Microscopic Hematuria: The urine appears normal, but red blood cells are detected during a laboratory test, such as a urinalysis [1.7.5].

Hematuria is a symptom, not a disease itself, and can originate from any part of the urinary tract, including the kidneys, ureters, bladder, or urethra [1.7.2]. Common causes, aside from medication side effects, include urinary tract infections (UTIs), kidney or bladder stones, an enlarged prostate, kidney disease, or, more seriously, cancer of the bladder or kidney [1.7.1, 1.7.5].

The Link: Can ELIQUIS Cause Hematuria?

Yes, ELIQUIS can cause hematuria. The official prescribing information lists hematuria as a bleeding-related adverse reaction [1.2.1, 1.2.2]. In a key clinical study (AMPLIFY), hematuria was observed in 1.7% of patients taking apixaban [1.2.1]. The genitourinary system is a documented site for bleeding in patients on this medication [1.2.2].

While ELIQUIS can induce bleeding on its own, it's crucial to understand that it can also unmask an underlying urological condition. An issue that might not normally cause bleeding, like a small bladder tumor or stone, could begin to bleed when the blood's clotting ability is reduced by an anticoagulant [1.4.4, 1.4.1]. Therefore, any instance of hematuria while on ELIQUIS warrants a thorough medical investigation to rule out other serious causes [1.4.2].

Factors Increasing Hematuria Risk on ELIQUIS

Several factors can heighten the risk of bleeding, including hematuria, for individuals taking ELIQUIS:

  • Kidney Impairment: Since about 27% of apixaban is cleared by the kidneys, impaired renal function can lead to higher concentrations of the drug in the blood, increasing bleeding risk [1.3.2, 1.9.4]. Studies show patients with moderately reduced kidney function can have twice the concentration of apixaban compared to those with normal function, even on the same dose [1.9.1].
  • Concomitant Medications: Taking other drugs that increase bleeding risk, like NSAIDs (ibuprofen, naproxen), aspirin, or certain antidepressants (SSRIs, SNRIs), significantly raises the potential for bleeding events [1.6.3, 1.8.5].
  • Advanced Age and Low Body Weight: The standard dosage may need to be adjusted in patients who are over 80 years old or weigh less than or equal to 60 kg, especially when combined with elevated serum creatinine, due to a higher risk of bleeding [1.6.3].
  • Underlying Conditions: A history of bleeding problems, liver disease, or certain urological conditions can predispose a patient to hematuria [1.6.5, 1.7.1].

Comparison with Other Anticoagulants

When compared to other common anticoagulants, the risk of bleeding varies.

Anticoagulant Mechanism of Action Bleeding/Hematuria Risk Profile
ELIQUIS (Apixaban) Direct Factor Xa Inhibitor Generally associated with a lower risk of major bleeding compared to warfarin and rivaroxaban [1.5.1, 1.5.3, 1.5.2].
XARELTO (Rivaroxaban) Direct Factor Xa Inhibitor Studies suggest a higher risk of bleeding complications, including gastrointestinal bleeding and hematuria, compared to apixaban [1.5.1, 1.5.4].
Warfarin (Coumadin) Vitamin K Antagonist ELIQUIS has demonstrated significantly less major bleeding compared to warfarin in major clinical trials [1.5.3, 1.8.3]. Requires regular monitoring (INR).

Studies have found that apixaban is associated with a lower incidence of major bleeding events than rivaroxaban [1.5.2, 1.5.5]. One study noted that hematuria-related complications were more common with anticoagulants in general, with rivaroxaban having the highest rate among several direct oral anticoagulants [1.2.5].

What to Do If You Experience Hematuria on ELIQUIS

If you are taking ELIQUIS and notice blood in your urine, it is essential to contact your doctor immediately [1.4.1, 1.8.1]. Do not stop taking ELIQUIS unless specifically instructed by your healthcare provider, as stopping suddenly can increase your risk of a stroke or blood clot [1.6.3, 1.8.2].

Your doctor will likely recommend:

  1. Medical Evaluation: To assess the severity of the bleeding and investigate the underlying cause [1.4.3]. This often involves a physical exam, urinalysis, blood tests, and imaging of the urinary tract (like an ultrasound or CT scan) [1.4.4].
  2. Urological Consultation: A urologist may perform a cystoscopy (inserting a small camera into the bladder) to directly visualize the urinary tract lining and identify the source of bleeding [1.7.3].
  3. Medication Management: Depending on the severity and cause, your doctor might temporarily pause ELIQUIS, adjust the dose, or, in cases of severe bleeding, administer a reversal agent like andexanet alfa [1.4.2, 1.4.3].

Conclusion

To answer the question, "Can ELIQUIS cause hematuria?"—yes, it is a known and documented side effect stemming from its function as a blood thinner [1.2.1, 1.8.4]. While ELIQUIS has a favorable safety profile compared to some other anticoagulants, the risk of bleeding remains [1.5.3, 1.5.2]. Hematuria while taking ELIQUIS should never be ignored. It serves as a critical signal to seek prompt medical attention to both manage the immediate bleeding and to investigate and rule out any other serious underlying health conditions [1.4.1]. Always maintain open communication with your healthcare provider about any side effects you experience.

Frequently Asked Questions

In one major clinical trial (AMPLIFY), hematuria was reported as an adverse reaction in 1.7% of patients taking ELIQUIS [1.2.1]. It is listed as a potential bleeding-related side effect [1.2.2].

No, do not stop taking ELIQUIS on your own. Stopping suddenly can significantly increase your risk of having a stroke or a blood clot [1.6.3, 1.8.2]. Contact your prescribing doctor immediately for guidance.

While it can be a direct side effect of the medication, it can also signal a serious underlying condition like kidney stones, an infection, or bladder cancer [1.7.1, 1.4.4]. Therefore, it should always be evaluated by a healthcare professional promptly [1.4.1].

Yes. A significant portion of ELIQUIS is cleared by the kidneys, so impaired kidney function can lead to higher levels of the drug in your system, which increases the risk of bleeding, including hematuria [1.9.1, 1.9.4].

You should be very cautious. Taking NSAIDs like ibuprofen or aspirin with ELIQUIS significantly increases your risk of bleeding [1.6.3, 1.8.5]. Always consult your doctor before combining these medications.

Yes, for severe and uncontrolled bleeding, a specific reversal agent called andexanet alfa is available to counteract the effects of apixaban [1.4.3, 1.8.5].

Several large studies have shown that ELIQUIS (apixaban) is associated with a significantly lower risk of major bleeding complications compared to both Xarelto (rivaroxaban) and warfarin [1.5.1, 1.5.2, 1.5.3].

References

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Medical Disclaimer

This content is for informational purposes only and should not replace professional medical advice.