Can Xarelto (rivaroxaban) cause hearing loss?

Rivaroxaban (Xarelto) and Hearing Loss

Based on current evidence, there is no established association between rivaroxaban (Xarelto) and hearing loss. The available clinical guidelines and research do not identify hearing loss as a known side effect of rivaroxaban or other direct oral anticoagulants (DOACs).

Assessment of Evidence

Direct Oral Anticoagulants and Ototoxicity

• No clinical guidelines for DOACs, including rivaroxaban, list hearing loss or tinnitus as a known adverse effect 1
• The comprehensive CHEST guidelines on antithrombotic therapy for atrial fibrillation do not mention hearing-related adverse effects for rivaroxaban 1
• The European Society of Cardiology guidelines similarly do not include hearing loss among the side effects of rivaroxaban 1

Known Side Effects of Rivaroxaban

The most common adverse effects of rivaroxaban include:

• Bleeding complications
• Dyspepsia (which may be ameliorated by taking with food or using a proton pump inhibitor) 1
• Potential drug interactions (though fewer than with warfarin)

Medications Known to Cause Hearing Loss

Several medications are established as potentially ototoxic, including:

• Aminoglycoside antibiotics
• Platinum-based chemotherapy agents (cisplatin, carboplatin) 1, 2
• Loop diuretics, particularly furosemide 3, 2
• Macrolide antibiotics (may cause reversible hearing loss) 1
• Salicylates in high doses 2

Clinical Approach to Suspected Medication-Induced Hearing Loss

If a patient on rivaroxaban experiences hearing loss:

1. Evaluate for other causes:

   • Assess for Ménière's disease, vestibular neuritis, labyrinthitis, or other common causes of hearing loss 1
   • Consider concomitant medications with known ototoxic potential

2. Review medication history:

   • Check for other medications that could cause hearing loss (aminoglycosides, loop diuretics, macrolides)
   • Evaluate for drug interactions that might potentiate ototoxicity

3. Audiometric testing:

   • Obtain baseline audiometry to document the type and severity of hearing loss
   • Sensorineural hearing loss is the typical pattern in drug-induced ototoxicity

4. Management considerations:

   • If no other cause is identified and temporal relationship with rivaroxaban is strong, discuss with patient's cardiologist about alternative anticoagulation options
   • Consider reporting to pharmacovigilance systems as a potential adverse drug reaction

Important Considerations

• Causality assessment: While isolated case reports of unexpected drug effects may exist, establishing causality requires stronger evidence
• Risk-benefit analysis: The decision to continue or discontinue rivaroxaban should weigh the risk of thromboembolism against the hearing symptoms
• Alternative anticoagulants: If a change in therapy is warranted, options include other DOACs (apixaban, dabigatran, edoxaban) or warfarin with appropriate monitoring

Conclusion

There is currently insufficient evidence to establish rivaroxaban as a cause of hearing loss. If a patient on rivaroxaban experiences hearing symptoms, a thorough evaluation for other causes should be conducted, and any suspected adverse drug reaction should be reported to appropriate authorities for further investigation.