{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,2,26]],"date-time":"2026-02-26T15:19:47Z","timestamp":1772119187380,"version":"3.50.1"},"reference-count":29,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2025,8,13]],"date-time":"2025-08-13T00:00:00Z","timestamp":1755043200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.springernature.com\/gp\/researchers\/text-and-data-mining"},{"start":{"date-parts":[[2025,8,13]],"date-time":"2025-08-13T00:00:00Z","timestamp":1755043200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/www.springernature.com\/gp\/researchers\/text-and-data-mining"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Naunyn-Schmiedeberg's Arch Pharmacol"],"published-print":{"date-parts":[[2026,1]]},"DOI":"10.1007\/s00210-025-04501-4","type":"journal-article","created":{"date-parts":[[2025,8,13]],"date-time":"2025-08-13T06:51:57Z","timestamp":1755067917000},"page":"1425-1439","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["Signal mining for non-bleeding adverse event in novel oral anticoagulants: a pharmacovigilance study based on FAERS database"],"prefix":"10.1007","volume":"399","author":[{"given":"Guimu","family":"Guo","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ying","family":"Song","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sijie","family":"Chang","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jinhua","family":"Zhang","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"297","published-online":{"date-parts":[[2025,8,13]]},"reference":[{"issue":"8","key":"4501_CR1","doi-asserted-by":"publisher","first-page":"1654","DOI":"10.1111\/bcp.14221","volume":"86","author":"G Bonaldo","year":"2020","unstructured":"Bonaldo G, Vaccheri A, Motola D (2020) Direct-acting oral anticoagulants and alopecia: the valuable support of postmarketing data. Br J Clin Pharmacol 86(8):1654\u20131660. https:\/\/doi.org\/10.1111\/bcp.14221","journal-title":"Br J Clin Pharmacol"},{"issue":"3","key":"4501_CR2","doi-asserted-by":"publisher","first-page":"246","DOI":"10.1016\/j.cgh.2012.10.021","volume":"11","author":"P Bytzer","year":"2013","unstructured":"Bytzer P, Connolly SJ, Yang S, Ezekowitz M, Formella S, Reilly PA, Aisenberg J (2013) Analysis of upper gastrointestinal adverse events among patients given dabigatran in the RE-LY trial. Clin Gastroenterol Hepatol 11(3):246-252 e241-245. https:\/\/doi.org\/10.1016\/j.cgh.2012.10.021","journal-title":"Clin Gastroenterol Hepatol"},{"issue":"4","key":"4501_CR3","doi-asserted-by":"publisher","first-page":"339","DOI":"10.1080\/14740338.2018.1439474","volume":"17","author":"D Caldeira","year":"2018","unstructured":"Caldeira D, Rodrigues R, Abreu D, Anes AM, Rosa MM, Ferreira JJ (2018) Suspected adverse drug reaction reports with oral anticoagulants in Portugal: a pharmacovigilance study. Expert Opin Drug Saf 17(4):339\u2013345. https:\/\/doi.org\/10.1080\/14740338.2018.1439474","journal-title":"Expert Opin Drug Saf"},{"issue":"11","key":"4501_CR4","doi-asserted-by":"publisher","first-page":"e2243307","DOI":"10.1001\/jamanetworkopen.2022.43307","volume":"5","author":"YH Chan","year":"2022","unstructured":"Chan YH, Chao TF, Chen SW, Lee HF, Chen WM, Li PR et al (2022) Development of interstitial lung disease among patients with atrial fibrillation receiving oral anticoagulants in Taiwan. JAMA Netw Open 5(11):e2243307. https:\/\/doi.org\/10.1001\/jamanetworkopen.2022.43307","journal-title":"JAMA Netw Open"},{"key":"4501_CR5","unstructured":"Dabigatran FDA-Approved Drugs (Update date: November 2023). https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2023\/214358s007lbl.pdf"},{"issue":"4","key":"4501_CR6","doi-asserted-by":"publisher","first-page":"749","DOI":"10.1016\/j.thromres.2015.07.030","volume":"136","author":"N De Crem","year":"2015","unstructured":"De Crem N, Peerlinck K, Vanassche T, Vanheule K, Debaveye B, Middeldorp S et al (2015) Abnormal uterine bleeding in VTE patients treated with rivaroxaban compared to vitamin K antagonists. Thromb Res 136(4):749\u2013753. https:\/\/doi.org\/10.1016\/j.thromres.2015.07.030","journal-title":"Thromb Res"},{"key":"4501_CR7","doi-asserted-by":"publisher","first-page":"e071752","DOI":"10.1136\/bmj-2022-071752","volume":"379","author":"MM Dhodapkar","year":"2022","unstructured":"Dhodapkar MM, Shi X, Ramachandran R, Chen EM, Wallach JD, Ross JS (2022) Characterization and corroboration of safety signals identified from the US food and drug administration adverse event reporting system, 2008\u201319: cross sectional study. BMJ 379:e071752. https:\/\/doi.org\/10.1136\/bmj-2022-071752","journal-title":"BMJ"},{"key":"4501_CR8","doi-asserted-by":"publisher","first-page":"79","DOI":"10.1146\/annurev-pharmtox-010611-134633","volume":"52","author":"J Fareed","year":"2012","unstructured":"Fareed J, Thethi I, Hoppensteadt D (2012) Old versus new oral anticoagulants: focus on pharmacology. Annu Rev Pharmacol Toxicol 52:79\u201399. https:\/\/doi.org\/10.1146\/annurev-pharmtox-010611-134633","journal-title":"Annu Rev Pharmacol Toxicol"},{"key":"4501_CR9","doi-asserted-by":"publisher","first-page":"60","DOI":"10.1016\/j.phrs.2018.07.016","volume":"135","author":"P Gelosa","year":"2018","unstructured":"Gelosa P, Castiglioni L, Tenconi M, Baldessin L, Racagni G, Corsini A, Bellosta S (2018) Pharmacokinetic drug interactions of the non-vitamin K antagonist oral anticoagulants (NOACs). Pharmacol Res 135:60\u201379. https:\/\/doi.org\/10.1016\/j.phrs.2018.07.016","journal-title":"Pharmacol Res"},{"issue":"2","key":"4501_CR10","doi-asserted-by":"publisher","first-page":"151","DOI":"10.5811\/cpcem.2018.2.37096","volume":"2","author":"C Goldfine","year":"2018","unstructured":"Goldfine C, Glazer C, Ratzan RM (2018) Spontaneous spinal epidural hematoma from rivaroxaban. Clin Pract Cases Emerg Med 2(2):151\u2013154. https:\/\/doi.org\/10.5811\/cpcem.2018.2.37096","journal-title":"Clin Pract Cases Emerg Med"},{"key":"4501_CR11","doi-asserted-by":"publisher","first-page":"107602962412813","DOI":"10.1177\/10760296241281366","volume":"30","author":"N Hassan","year":"2024","unstructured":"Hassan N, Schapkaitz E, Rhemtula H, Ncete N (2024) Incidence and impact on quality of life of heavy menstrual bleeding in women on oral anticoagulant therapy. Clin Appl Thromb Hemost 30:10760296241281366. https:\/\/doi.org\/10.1177\/10760296241281366","journal-title":"Clin Appl Thromb Hemost"},{"issue":"7","key":"4501_CR12","doi-asserted-by":"publisher","first-page":"685","DOI":"10.1007\/s40264-018-0650-6","volume":"41","author":"M Hellfritzsch","year":"2018","unstructured":"Hellfritzsch M, Rasmussen L, Hallas J, Pottegard A (2018) Using the symmetry analysis design to screen for adverse effects of non-vitamin K antagonist oral anticoagulants. Drug Saf 41(7):685\u2013695. https:\/\/doi.org\/10.1007\/s40264-018-0650-6","journal-title":"Drug Saf"},{"issue":"1","key":"4501_CR13","doi-asserted-by":"publisher","first-page":"104","DOI":"10.1016\/j.jacc.2019.01.011","volume":"74","author":"CT January","year":"2019","unstructured":"January CT, Wann LS, Calkins H, Chen LY, Cigarroa JE, Cleveland JC Jr et al (2019) 2019 AHA\/ACC\/HRS focused update of the 2014 AHA\/ACC\/HRS guideline for the management of patients with atrial fibrillation: a report of the American college of cardiology\/American heart association task force on clinical practice guidelines and the heart rhythm society. J Am Coll Cardiol 74(1):104\u2013132. https:\/\/doi.org\/10.1016\/j.jacc.2019.01.011","journal-title":"J Am Coll Cardiol"},{"key":"4501_CR14","doi-asserted-by":"publisher","first-page":"e937017","DOI":"10.12659\/AJCR.937017","volume":"23","author":"J Kovacs","year":"2022","unstructured":"Kovacs J, Talib S, Khashan A, Garsondiya B, Carson MP (2022) A 77-year-old man with heparin-induced aldosterone suppression causing hyperkalemia. Am J Case Rep 23:e937017. https:\/\/doi.org\/10.12659\/AJCR.937017","journal-title":"Am J Case Rep"},{"issue":"9","key":"4501_CR15","doi-asserted-by":"publisher","first-page":"e70525","DOI":"10.7759\/cureus.70525","volume":"16","author":"AA Limardo","year":"2024","unstructured":"Limardo AA, Berrios JJ, Pagan A, de Jesus R, Espinet R (2024) Spontaneous spinal subdural hematoma associated with rivaroxaban and aspirin use: a report of a rare case. Cureus 16(9):e70525. https:\/\/doi.org\/10.7759\/cureus.70525","journal-title":"Cureus"},{"key":"4501_CR16","doi-asserted-by":"publisher","first-page":"1527","DOI":"10.2147\/DDDT.S203112","volume":"13","author":"S Lin","year":"2019","unstructured":"Lin S, Wang Y, Zhang L, Guan W (2019) Dabigatran must be used carefully: literature review and recommendations for management of adverse events. Drug Des Devel Ther 13:1527\u20131533. https:\/\/doi.org\/10.2147\/DDDT.S203112","journal-title":"Drug Des Devel Ther"},{"issue":"19","key":"4501_CR17","doi-asserted-by":"publisher","first-page":"4693","DOI":"10.1182\/bloodadvances.2020001830","volume":"4","author":"TL Ortel","year":"2020","unstructured":"Ortel TL, Neumann I, Ageno W, Beyth R, Clark NP, Cuker A et al (2020) American society of hematology 2020 guidelines for management of venous thromboembolism: treatment of deep vein thrombosis and pulmonary embolism. Blood Adv 4(19):4693\u20134738. https:\/\/doi.org\/10.1182\/bloodadvances.2020001830","journal-title":"Blood Adv"},{"issue":"6","key":"4501_CR18","doi-asserted-by":"publisher","first-page":"575","DOI":"10.1016\/s0002-9343(99)80017-5","volume":"98","author":"JR Oster","year":"1995","unstructured":"Oster JR, Singer I, Fishman LM (1995) Heparin-induced aldosterone suppression and hyperkalemia. Am J Med 98(6):575\u2013586. https:\/\/doi.org\/10.1016\/s0002-9343(99)80017-5","journal-title":"Am J Med"},{"issue":"19","key":"4501_CR19","doi-asserted-by":"publisher","first-page":"2162","DOI":"10.1016\/j.jacc.2018.03.023","volume":"71","author":"A Qamar","year":"2018","unstructured":"Qamar A, Vaduganathan M, Greenberger NJ, Giugliano RP (2018) Oral anticoagulation in patients with liver disease. J Am Coll Cardiol 71(19):2162\u20132175. https:\/\/doi.org\/10.1016\/j.jacc.2018.03.023","journal-title":"J Am Coll Cardiol"},{"issue":"11","key":"4501_CR20","doi-asserted-by":"publisher","first-page":"1191","DOI":"10.1007\/s40264-020-00990-9","volume":"43","author":"E Raschi","year":"2020","unstructured":"Raschi E, Fusaroli M, Diemberger I, Poluzzi E (2020) Direct oral anticoagulants and interstitial lung disease: emerging clues from pharmacovigilance. Drug Saf 43(11):1191\u20131194. https:\/\/doi.org\/10.1007\/s40264-020-00990-9","journal-title":"Drug Saf"},{"issue":"5","key":"4501_CR21","doi-asserted-by":"publisher","first-page":"461","DOI":"10.7150\/ijms.7967","volume":"11","author":"T Sakaeda","year":"2014","unstructured":"Sakaeda T, Kadoyama K, Minami K, Okuno Y (2014) Commonality of drug-associated adverse events detected by 4 commonly used data mining algorithms. Int J Med Sci 11(5):461\u2013465. https:\/\/doi.org\/10.7150\/ijms.7967","journal-title":"Int J Med Sci"},{"issue":"7","key":"4501_CR22","doi-asserted-by":"publisher","first-page":"e5108","DOI":"10.7759\/cureus.5108","volume":"11","author":"Z Sanford","year":"2019","unstructured":"Sanford Z, Nanjundappa A, Annie FH, Embrey S (2019) Adrenal hemorrhage in a patient anticoagulated with apixaban with antiphospholipid syndrome. Cureus 11(7):e5108. https:\/\/doi.org\/10.7759\/cureus.5108","journal-title":"Cureus"},{"issue":"1","key":"4501_CR23","doi-asserted-by":"publisher","first-page":"39","DOI":"10.1186\/s12959-022-00397-9","volume":"20","author":"E Sheklabadi","year":"2022","unstructured":"Sheklabadi E, Sharifi Y, Tabarraee M, Tamehrizadeh SS, Rabiee P, Hadaegh F (2022) Adrenal hemorrhage following direct oral anticoagulant (DOAC) therapy: two case reports and literature review. Thromb J 20(1):39. https:\/\/doi.org\/10.1186\/s12959-022-00397-9","journal-title":"Thromb J"},{"issue":"10","key":"4501_CR24","doi-asserted-by":"publisher","first-page":"1685","DOI":"10.1093\/europace\/euab218","volume":"23","author":"J Steffel","year":"2021","unstructured":"Steffel J, Heidbuchel H (2021) 2021 European heart rhythm association practical guide on the use of non-vitamin K antagonist oral anticoagulants in patients with atrial fibrillation: comment-authors\u2019 reply. Europace 23(10):1685\u20131686. https:\/\/doi.org\/10.1093\/europace\/euab218","journal-title":"Europace"},{"issue":"7","key":"4501_CR25","doi-asserted-by":"publisher","first-page":"1767","DOI":"10.1016\/j.jstrokecerebrovasdis.2016.03.036","volume":"25","author":"S Tomari","year":"2016","unstructured":"Tomari S, Homma K, Noguchi T, Aiba T, Matsuki T, Suzuki R et al (2016) Development of interstitial lung disease after initiation of apixaban anticoagulation therapy. J Stroke Cerebrovasc Dis 25(7):1767\u20131769. https:\/\/doi.org\/10.1016\/j.jstrokecerebrovasdis.2016.03.036","journal-title":"J Stroke Cerebrovasc Dis"},{"issue":"1","key":"4501_CR26","doi-asserted-by":"publisher","first-page":"1","DOI":"10.1007\/s40801-015-0056-z","volume":"3","author":"MM Watras","year":"2016","unstructured":"Watras MM, Patel JP, Arya R (2016) Traditional anticoagulants and hair loss: a role for direct oral anticoagulants? A review of the literature. Drugs Real World Outcomes 3(1):1\u20136. https:\/\/doi.org\/10.1007\/s40801-015-0056-z","journal-title":"Drugs Real World Outcomes"},{"key":"4501_CR27","doi-asserted-by":"publisher","first-page":"1399172","DOI":"10.3389\/fphar.2024.1399172","volume":"15","author":"J Wu","year":"2024","unstructured":"Wu J, Wu J, Tang B, Wang X, Wei F, Zhang Y et al (2024) Suspected adverse drug reactions of rivaroxaban reported in the United States Food and Drug Administration adverse event reporting system database: a pharmacovigilance study. Front Pharmacol 15:1399172. https:\/\/doi.org\/10.3389\/fphar.2024.1399172","journal-title":"Front Pharmacol"},{"key":"4501_CR28","doi-asserted-by":"publisher","first-page":"801199","DOI":"10.3389\/fonc.2021.801199","volume":"11","author":"H Yang","year":"2021","unstructured":"Yang H, Yu X, An Z (2021) Cutaneous toxicity associated with enfortumab vedotin: a real-word study leveraging U.S. food and drug administration adverse event reporting system. Front Oncol 11:801199. https:\/\/doi.org\/10.3389\/fonc.2021.801199","journal-title":"Front Oncol"},{"issue":"4","key":"4501_CR29","doi-asserted-by":"publisher","first-page":"456","DOI":"10.1002\/jcph.21","volume":"53","author":"M Zaleski","year":"2013","unstructured":"Zaleski M, Dabage N, Paixao R, Muniz J (2013) Dabigatran-induced hyperkalemia in a renal transplant recipient: a clinical observation. J Clin Pharmacol 53(4):456\u2013458. https:\/\/doi.org\/10.1002\/jcph.21","journal-title":"J Clin Pharmacol"}],"container-title":["Naunyn-Schmiedeberg's Archives of Pharmacology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s00210-025-04501-4.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1007\/s00210-025-04501-4","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s00210-025-04501-4.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,2,19]],"date-time":"2026-02-19T22:08:59Z","timestamp":1771538939000},"score":1,"resource":{"primary":{"URL":"https:\/\/link.springer.com\/10.1007\/s00210-025-04501-4"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,8,13]]},"references-count":29,"journal-issue":{"issue":"1","published-print":{"date-parts":[[2026,1]]}},"alternative-id":["4501"],"URL":"https:\/\/doi.org\/10.1007\/s00210-025-04501-4","relation":{"has-preprint":[{"id-type":"doi","id":"10.21203\/rs.3.rs-6624124\/v1","asserted-by":"object"}]},"ISSN":["0028-1298","1432-1912"],"issn-type":[{"value":"0028-1298","type":"print"},{"value":"1432-1912","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,8,13]]},"assertion":[{"value":"9 May 2025","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"29 July 2025","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"13 August 2025","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"Not applicable.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval"}},{"value":"Not applicable.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent to participate"}},{"value":"Not applicable.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"The authors declare no competing interests.","order":5,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}]}}