DOI: 10.12890/2026_006178

Bleeding disorder, a newly recognized adverse event following sacubitril/valsartan therapy

Authors

  • Yaser W. Al-Omari Department of Pharmacy, Prince Faisal Bin Alhussein Hospital, Ministry of Health, Zarqa-Rusaifeh, Jordan; Department of Internal Medicine, Prince Faisal Bin Alhussein Hospital, Ministry of Health, Zarqa-Rusaifeh, Jordan
  • Samer A. Mustafa Department of Internal Medicine, Prince Faisal Bin Alhussein Hospital, Ministry of Health, Zarqa-Rusaifeh, Jordan
  • Ali H. Saleh Department of Internal Medicine, Prince Faisal Bin Alhussein Hospital, Ministry of Health, Zarqa-Rusaifeh, Jordan
  • Wesam S. Abdel-Razaq College of Pharmacy, King Saud bin Abdulaziz University for Health Sciences, Ministry of National Guard Health Affairs, Riyadh, Saudi Arabia; King Abdullah International Medical Research Centre, Ministry of National Guard Health Affairs, Riyadh, Saudi Arabia 0000-0003-3745-2839

razaqw@ksau-hs.edu.sa

Keywords

Sacubitril/valsartan, Entresto, adverse drug reaction, bleeding disorder, patient safety

Abstract

Introduction: Sacubitril/valsartan (Entresto) is the only currently approved angiotensin receptor–neprilysin inhibitor (ARNI) drug. It demonstrates important therapeutic outcomes in heart failure patients by reducing hospitalizations and deaths. ARNI is generally safe but concerns about adverse drug reactions (ADRs) exist. This report documents a potential bleeding disorder, evidenced by elevated prothrombin time (PT) and international normalized ratio (INR), as a newly identified ADR.
Case description: Despite not receiving anticoagulant medication, three male heart failure patients had elevated PT/INR values within 14 days to four months of initiating Entresto 50 mg twice daily. Temporary discontinuation (dechallenging) of Entresto resulted in a decline in PT/INR, while it increased upon re-challenge in at least one patient. Laboratory findings showed varying degrees of anaemia, occasional renal and hepatic abnormalities, with normal platelet counts. Naranjo scores (6–8) support a probable causal relationship between Entresto and the bleeding tendency, warranting careful coagulation monitoring during treatment.
Conclusion: This case series explicitly identified a probable causal relationship between Entresto (ARNI) and a potential bleeding risk as evaluated by the Naranjo ADR probability scale. By highlighting this previously unidentified ADR, this report attempts to raise awareness among healthcare practitioners regarding the need for vigilant monitoring of coagulation parameters in high-risk patients, even without concomitant anticoagulant treatment.

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References

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Published

2026-03-11

Issue

Vol. 13 No. 4 (2026)

Categories

How to Cite

1.
Al-Omari YW, Mustafa SA, Saleh AH, Abdel-Razaq WS. Bleeding disorder, a newly recognized adverse event following sacubitril/valsartan therapy. EJCRIM [Internet]. 2026 Mar. 11 [cited 2026 Nov. 3];13(4). Available from: https://ejcrim.com/index.php/ejcrim/article/view/6178