Side Effects of rivaroxaban: A Synthesis of Findings from 27 Studies

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Original Abstract of the Article

Major Research Findings

Rivaroxaban, a novel oral anticoagulant, has been widely used for the prevention of stroke and thromboembolism. However, various side effects associated with rivaroxaban use have been reported in recent years. 12 introduced a case where priapism occurred after rivaroxaban administration. The case suggests that physicians have an obligation to inform patients of the possibility of side effects, even if they are rare. Furthermore, 13 reported a case of spontaneous atraumatic splenic rupture following rivaroxaban administration. This suggests that rivaroxaban may be associated with a higher risk of bleeding than conventional warfarin. In addition, 4 reports a case where drug hypersensitivity syndrome was induced by rivaroxaban administration, leading to acute renal failure. This suggests that rivaroxaban may have the potential to cause kidney dysfunction. 1 reported a case of thrombocytopenia developing after rivaroxaban administration. This suggests that rivaroxaban has the potential to cause thrombocytopenia.

Reasons for Side Effects

Rivaroxaban is a coagulation factor Xa inhibitor. Coagulation factor Xa plays a crucial role in blood coagulation. Rivaroxaban inhibits blood coagulation by inhibiting coagulation factor Xa, making it effective in preventing stroke and thromboembolism but also increasing the risk of bleeding.

Common Side Effects

Bleeding

Rivaroxaban is known to increase the risk of bleeding. 21 showed that rivaroxaban is associated with a lower risk of gastrointestinal bleeding than conventional warfarin, but the risk of bleeding is not zero. reported a case of hemopericardium leading to cardiac tamponade after rivaroxaban administration. 22 also showed that rivaroxaban is associated with a higher rate of intracranial hemorrhage compared to warfarin.

Gastrointestinal Side Effects

Rivaroxaban can cause gastrointestinal side effects. 21 reported diarrhea after rivaroxaban administration.

Skin

Rivaroxaban can cause skin side effects. 26 reported a case of warfarin-induced skin necrosis following rivaroxaban administration.

Kidney

Rivaroxaban can cause kidney side effects. 4 reported a case of drug hypersensitivity syndrome leading to acute renal failure after rivaroxaban administration.

Thrombocytopenia

Rivaroxaban can cause thrombocytopenia. 1 reported a case of thrombocytopenia developing after rivaroxaban administration.

Other

In addition to the above, 24 reported a case of a life-threatening non-allergic drug hypersensitivity reaction to rivaroxaban. 12 reported a case where a patient developed anticoagulant-induced priapism after surgery.

Countermeasures for Side Effects

Bleeding

As rivaroxaban increases the risk of bleeding, caution is required during administration. 3 describes the development of andexanet alfa, a drug designed to reverse the anticoagulant effects of rivaroxaban.

Gastrointestinal Side Effects

Consult your doctor if you are concerned about gastrointestinal side effects.

Skin

Consult your doctor if you are concerned about skin side effects.

Kidney

Consult your doctor if you are concerned about kidney side effects. If you have impaired kidney function, consult your doctor before taking rivaroxaban. 4 suggests that further research on kidney side effects is necessary.

Thrombocytopenia

Consult your doctor if you are concerned about thrombocytopenia.

Comparison Between Studies

Commonalities Between Studies

Numerous studies have shown that rivaroxaban is more effective than conventional warfarin in preventing stroke and thromboembolism. Moreover, many studies have shown that rivaroxaban increases the risk of bleeding.

Differences Between Studies

There are studies that have shown that rivaroxaban is associated with a lower risk of gastrointestinal bleeding than conventional warfarin, as well as studies that have shown that rivaroxaban is associated with a higher risk. indicates that rivaroxaban may cause side effects not observed with conventional warfarin, such as hemopericardium. 22 also shows that rivaroxaban is associated with a higher rate of intracranial hemorrhage compared to warfarin.

Points to Note Regarding Application to Real Life

Rivaroxaban is a drug that increases the risk of bleeding. It is important to understand the risk of bleeding and be cautious when using rivaroxaban. Although drugs have been developed to reduce side effects, such as 3 , constant vigilance is necessary. Additionally, rivaroxaban can interact with other medications. If you are using rivaroxaban, inform your doctor about any other medications you are taking and follow your doctor's instructions.

Limitations of Current Research

Rivaroxaban is still a relatively new drug, and its side effects are not yet fully understood. 4 suggests that further research is needed.

Future Research Directions

Further research is necessary to better understand the side effects of rivaroxaban. Specifically, research needs to be conducted on long-term side effects, side effects caused by genetic polymorphism in rivaroxaban, and interactions of rivaroxaban with other drugs.

Conclusion

Rivaroxaban is a drug that is effective in preventing stroke and thromboembolism, but it also carries the risk of side effects such as bleeding. If you are using rivaroxaban, it is important to understand the risk of bleeding and be cautious. Additionally, rivaroxaban can interact with other medications. If you are using rivaroxaban, inform your doctor about any other medications you are taking and follow your doctor's instructions. The side effects of rivaroxaban are not yet fully understood. Further research is needed to better understand the side effects of rivaroxaban.

Literature analysis of 27 papers
Positive Content
20
Neutral Content
2
Negative Content
5
Article Type
0
2
2
4
24
1.

Thrombocytopenia due to rivaroxaban: A rare adverse effect.

Author: TığlıoğluMesut, AkyolPınar, SağlamBuğra, ArasMerih Reis, Afacan ÖztürkHacer Berna, YıldızAbdulkerim, AlbayrakMurat

Thrombocytopenia

This case report describes a patient with chronic atrial fibrillation who developed thrombocytopenia while taking rivaroxaban, a novel oral direct acting anticoagulant.

Case ReportsIn the medical field, a report that describes in detail a unique case, an unusual medical condition, or the effect of a treatment. Provides new insights and possibilities for treatment through individual patient cases.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

2.

Pharmacogenetic Approach for the Prevention of Rivaroxaban's ADRs: A Systematic Review and Meta-Analysis.

Author: MardiParham, AbbasiBahareh, ShafieeArman, AfsharmoghaddamTara

Rivaroxaban dosage
Rivaroxaban ADRs

This systematic review and meta-analysis found that the ABCB1 gene variant rs1045642 is associated with higher rivaroxaban levels. Identifying this genetic variant before administering rivaroxaban may help reduce adverse drug reactions.

Meta-AnalysisA statistical technique that integrates the results of multiple studies to draw more general conclusions about a particular issue.
Systematic ReviewA review that systematically collects, evaluates, and integrates relevant research to answer a specific research question.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

3.

Andexanet alfa: a recombinant mimetic of human factor Xa for the reversal of anticoagulant therapies.

Author: EscolarG, Diaz-RicartM, Arellano-RodrigoE

Anticoagulation reversal

This review discusses the clinical development of andexanet alfa, a modified recombinant human FXa molecule designed to reverse the anticoagulant effects of both direct and indirect FXa inhibitors. Andexanet alfa shows promise in reversing the anticoagulation of FXa inhibitors, but further research is needed to fully assess its efficacy and safety.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

5.

Complete recovery of deep venous thrombosis from Coombs (+) thrombotic thrombocytopenic purpura: case report.

Author: ZhouMi, YinJie

DVT

This case report describes a patient with acute thrombotic thrombocytopenic purpura (TTP) who developed catheter-associated deep vein thrombosis (DVT) after receiving plasma exchange (PEX) treatment.

Case ReportsIn the medical field, a report that describes in detail a unique case, an unusual medical condition, or the effect of a treatment. Provides new insights and possibilities for treatment through individual patient cases.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

6.

Direct (New) Oral Anticoagulants (DOACs): Drawbacks, Bleeding and Reversal.

Author: KarciogluOzgur, ZenginSehmus, OzkayaBilgen, ErsanEylem, YilmazSarper, AfacanGoksu, AbuskaDerya, HosseinzadehMandana, YeniocakSelman

Prevents VTE
Protects coagulation cascade
Treats thromboses
Bleeding

Direct oral anticoagulants (DOACs) are promising options for treating thromboses and venous thromboembolism (VTE) with lower bleeding risks than warfarin. However, DOACs carry a higher risk of gastrointestinal bleeding compared to warfarin. This review summarizes the side effects of DOACs in various clinical scenarios.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

8.

The management of livedoid vasculopathy focused on direct oral anticoagulants (DOACs): four case reports successfully treated with rivaroxaban.

Author: Franco MarquesGabriela, CriadoPaulo Ricardo, Alves Batista MoritaThâmara Cristiane, Cajas GarcíaMaría Salomé

Pain reduction
Ulcer prevention

Rivaroxaban, a direct oral anticoagulant, may be a promising treatment for livedoid vasculopathy, a thrombotic skin disease, reducing pain and ulcerations in patients.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

9.

Comparison of transesophageal echocardiography findings after different anticoagulation strategies in patients with atrial fibrillation: a systematic review and meta-analysis.

Author: YangJian, ZhangXuan, WangXi-Ying, ZhangChi, ChenSong-Zan, HuShen-Jiang

Anticoagulation

This meta-analysis compares the incidence of left atrial thrombi (LAT) between different anticoagulants. The results indicate that both vitamin K antagonists (VKAs) and non-vitamin K antagonist oral anticoagulants (NOACs) have been used to treat patients with atrial fibrillation and those undergoing ablation.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Meta-AnalysisA statistical technique that integrates the results of multiple studies to draw more general conclusions about a particular issue.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.
Systematic ReviewA review that systematically collects, evaluates, and integrates relevant research to answer a specific research question.

Language : English

10.

Influence of Polypharmacy on the Effectiveness and Safety of Rivaroxaban Versus Warfarin in Patients With Nonvalvular Atrial Fibrillation.

Author: MartinezBrandon K, BakerWilliam L, SoodNitesh A, BunzThomas J, MeineckeAnna-Katharina, ErikssonDaniel, ColemanCraig I

NVAF treatment
Polypharmacy

This study evaluated the impact of polypharmacy on the effectiveness and safety of rivaroxaban versus warfarin in patients with nonvalvular atrial fibrillation (NVAF).

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

12.

[Does a physician have to inform the patient about the rare risk of priapism before administering an anticoagulant?]

Author: VogelerMarcus

Informed consent
Priapism

This article discusses a legal case where a patient developed priapism after surgery due to anticoagulant use. The court found that the hospital was not obligated to provide detailed information about rare but possible side effects, but emphasized the physician's legal duty to personally inform patients about risks and side effects, even if they are uncommon.

Case ReportsIn the medical field, a report that describes in detail a unique case, an unusual medical condition, or the effect of a treatment. Provides new insights and possibilities for treatment through individual patient cases.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : German

13.

Atraumatic Splenic Rupture: A Notable Complication of Rivaroxaban Use.

Author: Ostos PerezCatherine A, MenchacaKristina, JonesCan X, Ostos PerezErika, IsaacShaun

Atraumatic splenic rupture
Bleeding complications

This case report highlights the potential association between direct oral anticoagulants (DOACs) and atraumatic splenic rupture. It emphasizes the importance of recognizing this rare but potentially fatal complication in patients on DOACs, especially those without previous risk factors.

Case ReportsIn the medical field, a report that describes in detail a unique case, an unusual medical condition, or the effect of a treatment. Provides new insights and possibilities for treatment through individual patient cases.

Language : English

16.

Optimal nonvitamin K antagonist oral anticoagulant therapy in a warfarin-sensitive patient after left atrial appendage closure: A case report.

Author: ShenLong, FangSha-Sha, GeHeng, QiaoZhi-Qing, GuZhi-Chun

Viable regimen

Rivaroxaban 15 mg daily after left atrial appendage closure (LAAC) may be a viable regimen in patients intolerant to warfarin.

Case ReportsIn the medical field, a report that describes in detail a unique case, an unusual medical condition, or the effect of a treatment. Provides new insights and possibilities for treatment through individual patient cases.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

17.

Anticoagulant-associated adverse drug reactions in 2013-15.

Author: EekAnne Katrine, StrømBjørn Oddvar, BakkehøiGine, Stenberg-NilsenHanne

Blood clots
Cognitive effects
Death
Hemorrhage

Direct-acting oral anticoagulants (DOACs) were associated with adverse events, including hemorrhages, blood clots, cognitive effects, headache, and hair loss. The highest comorbidity and number of reported deaths were observed with rivaroxaban.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

21.

New Anticoagulant Agents: Incidence of Adverse Drug Reactions and New Signals Thereof.

Author: Treceño-LobatoCarlos, Jiménez-SerraníaMaría-Isabel, Martínez-GarcíaRaquel, Corzo-DelibesFrancisco, Martín AriasLuis H

Lower risk of global bleeding
Potential osteoporosis protection
Diarrhea
Epistaxis
Hematoma

Nonvitamin K antagonist oral anticoagulants (NOACs) appear to be safer than vitamin K antagonists (VKAs) in real-life ambulatory settings. In a study of 334 patients, NOACs were associated with a lower risk of global bleeding, specifically dabigatran, and a potential protective effect against osteoporosis, especially with apixaban. VKAs were associated with a higher risk of epistaxis and hematoma.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Multicenter StudyResearch conducted in collaboration with multiple research institutions. It aims to collect a wide range of data and obtain more generalizable results.
Observational StudyResearch that observes and collects data on participants' behavior and outcomes in their natural state, without intervention.

Language : English

22.

Intracranial Hemorrhage Following Anticoagulant Treatment in Denmark: Spontaneous Adverse Drug Reaction Reports Versus Real-World Data.

Author: von OsmanskiBenedikte Irene, ScheldeAstrid Blicher, Jimenez-SolemEspen, NyelandMartin Erik, HorwitzHenrik

Lower ICH risk
ICH reports

This study investigated the high number of reports concerning intracranial hemorrhages (ICHs) following treatment with direct oral anticoagulants (DOACs) compared with warfarin in Denmark. The study found that despite DOACs being associated with a lower risk of ICH than warfarin in clinical trials, the number of reports concerning ICHs after DOAC treatment was higher in Denmark.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Observational StudyResearch that observes and collects data on participants' behavior and outcomes in their natural state, without intervention.

Language : English

23.

Warfarin is associated with higher rates of epistaxis compared to direct oral anticoagulants: A nationwide propensity score-weighted study.

Author: IngasonArnar B, RumbaEdward, HreinssonJohann P, AgustssonArnar S, LundSigrun H, PalssonDaniel A, ReynissonIndridi E, GudmundsdottirBrynja R, OnundarsonPall T, TryggvasonGeir, BjornssonEinar S

Reduced epistaxis
Epistaxis risk

A study of 2098 patients receiving apixaban, 474 receiving dabigatran, 3106 receiving rivaroxaban, and 1403 receiving warfarin found that warfarin treatment was associated with higher rates of clinically relevant epistaxis compared to direct oral anticoagulants.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

24.

Life-Threatening Non-Allergic Drug Hypersensitivity Reaction as a Very Rare Side Effect of Rivaroxaban Administration in the Netherlands.

Author: HakkenbrakNadia A G, TruijersMaarten

Thromboembolic disease prevention
Hemorrhagic complications
Non-hemorrhagic side effects

Rivaroxaban is a common drug used to prevent blood clots. Most side effects are related to bleeding, but there can also be other serious side effects.

Case ReportsIn the medical field, a report that describes in detail a unique case, an unusual medical condition, or the effect of a treatment. Provides new insights and possibilities for treatment through individual patient cases.

Language : English

25.

US Emergency Department Visits for Outpatient Adverse Drug Events, 2013-2014.

Author: ShehabNadine, LovegroveMaribeth C, GellerAndrew I, RoseKathleen O, WeidleNina J, BudnitzDaniel S

Focuses patient safety efforts
Increased use of anticoagulants and diabetes agents

The prevalence of emergency department visits for adverse drug events in the United States was estimated to be 4 per 1000 individuals in 2013 and 2014. The most common drug classes implicated were anticoagulants, antibiotics, diabetes agents, and opioid analgesics.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, U.S. Gov't, Non-P.H.S.Research funding provided by US government agencies other than the Public Health Service.

Language : English

26.

Anticoagulation therapy for thromboembolism prevention: a case of warfarin-induced skin necrosis in the setting of protein C deficiency.

Author: LaiJonathan, RamaiDaryl, AlchiRamiz, BloomfieldDennis

WISN treatment
Side effects

Rivaroxaban and dabigatran are alternatives to warfarin for treating thrombotic diseases in patients with protein C deficiency. This case report discusses the use of these drugs in a patient who developed warfarin-induced skin necrosis.

Case ReportsIn the medical field, a report that describes in detail a unique case, an unusual medical condition, or the effect of a treatment. Provides new insights and possibilities for treatment through individual patient cases.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

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