DOI: 10.12890/2026_006801

Sacubitril/Valsartan and elevated prothrombin time/international normalized ratio in the absence of anticoagulant therapy: a newly recognized potential adverse drug reaction

Authors

  • Tanuj Diyora Department of Cardiology, Dr KNS Memorial Institute of Medical Sciences, Barabanki, India
  • Ayush Ranajn Department of Cardiology, Health City Vistar Hospital, Lucknow, India

drtanujsmmanagement@gmail.com

Keywords

Sacubitril/valsartan, prothrombin time, INR, adverse drug reaction, heart failure

Abstract

Introduction: Sacubitril/valsartan is the first approved angiotensin receptor–neprilysin inhibitor (ARNI) and a cornerstone therapy for heart failure with reduced ejection fraction (HFrEF). While its clinical benefits are well established, adverse drug reactions (ADRs) beyond the recognized profile of hypotension, hyperkalaemia, and renal impairment remain incompletely characterized.
Case description: We report a case of isolated elevation in prothrombin time (PT) and international normalized ratio (INR) in a 58-year-old male with HFrEF receiving sacubitril/valsartan 49/51 mg twice daily, without any concurrent anticoagulant therapy. Approximately 6 weeks after initiation, PT was 18.4 seconds and INR was 1.7. Temporary discontinuation (dechallenge) led to normalization within 2 weeks; cautious re-challenge resulted in recurrent INR elevation. Naranjo Adverse Drug Reaction Probability Scale criteria yielded a score of +9, consistent with a probable drug-induced adverse event.
Conclusion: This case highlights a potentially underrecognized coagulopathic ADR associated with sacubitril/valsartan, manifesting as elevated PT/INR without anticoagulant use. Clinicians should consider periodic coagulation monitoring in patients on ARNI therapy. Further pharmacovigilance studies and mechanistic investigations are strongly warranted.

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Published

2026-06-03

Issue

Vol. 13 No. 6 (2026)

Categories

How to Cite

1.
Diyora T, Ranajn A. Sacubitril/Valsartan and elevated prothrombin time/international normalized ratio in the absence of anticoagulant therapy: a newly recognized potential adverse drug reaction. EJCRIM [Internet]. 2026 Jun. 3 [cited 2026 Nov. 3];13(6). Available from: https://ejcrim.com/index.php/ejcrim/article/view/6801