Objective To analyze adverse drug event (ADE) signals related to telavancin, dalbavancin, and oritavancin, three novel lipoglycopeptide antibiotics, using the FDA Adverse Event Reporting System (FAERS) and the World Health Organization drug adverse reaction reporting database(WHO-VigiAccess), and to provide references for the safe and rational application of these drugs.

Methods Based on the FAERS and WHO-VigiAccess database spanning from the first quarter of 2009 to the second quarter of 2025, ADE reports concerning telavancin, dalbavancin and oritavancin as the primary suspect drugs were collected. ADE signal was mined by the reporting odds ratio method and the Bayesian confidence propagation neural network methods.

Results A total of 162 ADEs involving 3,075 cases were identified from the FAERS database, among which telavancin was associated with 27 ADE signals, 131 cases; dalbavancin with 65 ADE signals, 888 cases; oritavancin with 70 ADE signals, 2,056 cases. In the WHO-VigiAccess database, 98 ADE signals covering 2,152 cases were detected, including 20 ADE signals (115 cases) for telavancin, 41 ADE signals (624 cases) for dalbavancin, and 37 ADE signals (1,413 cases) for oritavancin. ADE signals of the three lipoglycopeptide antibiotics involved 19 system organ class categories, mainly including skin and subcutaneous tissue disorders, general disorders and administration site conditions, gastrointestinal disorders. By comparison with the drug package inserts, a total of 15 newly identified ADEs were detected for telavancin, 38 for dalbavancin, and 31 for oritavancin, involving dyspnea, throat tightness, leukopenia, thrombocytopenia, increased transaminases, flank pain, rhabdomyolysis, cardiovascular disorders.

Conclusion The overall safety profile of three novel lipoglycopeptide antibiotics is manageable. In clinical practice, vigilance should be maintained against risks of renal injury, infusion-related hypersensitivity and delayed cutaneous reactions, while active monitoring for unlisted ADEs such as dyspnea, rhabdomyolysis and elevated transaminases should be strengthened.

1. 卢克鹏, 宋洪涛. 糖肽类抗生素在治疗MRSA感染中的PK/PD与给药方案的研究进展[J]. 中国医院药学杂志, 2014, 34(11): 952-957.LuKP, SongHT. PK/PD characteristics and the progress of research on the dosage regimen of glycopeptides antibiotics in the treatment of MRSA infection[J]. Chinese Journal of Hospital Pharmacy, 2014, 34(11): 952-957. DOI: 10.13286/j.cnki.chinhosppharmacyj.2014.11.28.

2. 罗云桃, 夏启航, 王庆忠, 等. VISA/VRSA相关耐药进化史及耐药进化代价[J]. 国际检验医学杂志, 2021, 42(16): 2001-2005.LuoYT, XiaQH, WangQZ, et al. Evolution history and cost of drug resistance related to VISA/VRSA[J]. International Journal of Laboratory Medicine, 2021, 42(16): 2001-2005. DOI: 10.3969/j.issn.1673-4130.2021.16.017.

3. WilsonSE, GrahamDR, WangW, et al. Telavancin in the treatment of concurrent staphylococcus aureus bacteremia: a retrospective analysis of ATLAS and ATTAIN studies[J]. Infect Dis Ther, 2017, 6(3): 413-422. DOI: 10.1007/s40121-017-0162-1.

4. 赖崇发, 严华成, 石磊. 抗MRSA感染新药的应用与研究进展[J]. 国外医药(抗生素分册), 2017, 38(4): 166-172, 178.LaiCF, YanHC, ShiL. The application and research progress of new anti-MRSA drugs[J]. World Notes on Antibiotics, 2017, 38(4): 166-172, 178. DOI: 10.13461/j.cnki.wna.005010.

5. 国家药品监督管理局. 2025年02月13日药品批准证明文件送达信息 [EB/OL]. (2025-02-13) [2026-01-07]. https://www.nmpa.gov.cn/zwfw/sdxx/sdxxyp/yppjfb/20250213135832129.html.

6. 黄妍, 于洋. 基于FAERS数据库的依折麦布单药与复方制剂不良事件信号挖掘[J]. 药物流行病学杂志, 2026, 35(2): 156-163.HuangY, YuY. Adverse drug event signal mining of ezetimibe monotherapy and compound preparations based on the FAERS database[J]. Chinese Journal of Pharmacoepidemiology, 2026, 35(2): 156-163. DOI: 10.12173/j.issn.1005-0698.202504037.

7. Ellis SimonsenSM, van OrmanER, HatchBE, et al. Cellulitis incidence in a defined population[J]. Epidemiol Infect, 2006, 134(2): 293-299. DOI: 10.1017/S095026880500484X.

8. VolpicelliL, VendittiM, OlivaA. Acute bacterial skin and skin structure infections in pediatric patients: potential role of dalbavancin[J]. Expert Rev Anti Infect Ther, 2023, 21(4): 329-341. DOI: 10.1080/14787210.2023.2182769.

9. GiorgobianiM, BurroughsMH, AntadzeT, et al. The safety and efficacy of dalbavancin and active comparator in pediatric patients with acute bacterial skin and skin structure infections[J]. Pediatr Infect Dis J, 2023, 42(3): 199-205. DOI: 10.1097/INF.0000000000003798.

10. WenzlerE, RodvoldKA. Telavancin: the long and winding road from discovery to food and drug administration approvals and future directions[J]. Clin Infect Dis, 2015, 61(Suppl 2): S38-S47. DOI: 10.1093/cid/civ522.

11. BarriereSL. The ATTAIN trials: efficacy and safety of telavancin compared with vancomycin for the treatment of hospital-acquired and ventilator-associated bacterial pneumonia[J]. Future Microbiol, 2014, 9(3): 281-289. DOI: 10.2217/fmb.14.4.

12. KalilAC, MeterskyML, KlompasM, et al. Management of adults with hospital-acquired and ventilator-associated pneumonia: 2016 clinical practice guidelines by the Infectious Diseases Society of America and the American Thoracic Society[J]. Clin Infect Dis, 2016, 63(5): e61-e111. DOI: 10.1093/cid/ciw504.

13. StevensDL, BisnoAL, ChambersHF, et al. Practice guidelines for the diagnosis and management of skin and soft tissue infections: 2014 update by the Infectious Diseases Society of America[J]. Clin Infect Dis, 2014, 59(2): e10-e52. DOI: 10.1093/cid/ciu444.

14. DuaneTM, HustonJM, CollomM, et al. Surgical Infection Society 2020 updated guidelines on the management of complicated skin and soft tissue infections[J]. Surg Infect (Larchmt), 2021, 22(4): 383-399. DOI: 10.1089/sur.2020.436.

15. HuangV, ClaytonNA, WelkerKH. Glycopeptide hypersensitivity and adverse reactions[J]. Pharmacy (Basel), 2020, 8(2): 70. DOI: 10.3390/pharmacy8020070.

16. JameW, BasgutB, AbdiA. Efficacy and safety of novel glycopeptides versus vancomycin for the treatment of gram-positive bacterial infections including methicillin resistant Staphylococcus aureus: a systematic review and meta-analysis[J]. PLoS One, 2021, 16(11): e0260539. DOI: 10.1371/journal.pone.0260539.

17. CoreyGR, RubinsteinE, StryjewskiME, et al. Potential role for telavancin in bacteremic infections due to gram-positive pathogens: focus on Staphylococcus aureus[J]. Clin Infect Dis, 2015, 60(5): 787-796. DOI: 10.1093/cid/ciu971.

18. 铁远, 刘蕾. 新型脂糖肽类抗生素达巴万星、奥利万星和特拉万星的研究进展[J]. 中国新药杂志, 2016, 25(22): 2542-2549.TieY, LiuL. Progress in research of the new lipoglycopeptide antimicrobial agents dalbavancin, oritavancin and telavancin[J]. Chinese Journal of New Drugs, 2016, 25(22): 2542-2549. DOI: 10.20251/j.cnki.1003-3734.2016.22.004.

19. PatelJH, ChurchwellMD, SeroogyJD, et al. Telavancin and hydroxy propyl-beta-cyclodextrin clearance during continuous renal replacement therapy: an in vitro study[J]. Int J Artif Organs, 2009, 32(10): 745-751. DOI: 10.1177/039139880903201006.

20. 管栋梁. 新型糖肽及脂肽类抗生素的设计、合成与抗耐药菌活性研究[D]. 上海: 中国科学院大学(中国科学院上海药物研究所), 2019.

21. 王婧雯, 吴寅, 文爱东. 新型糖肽类抗生素——达巴万星[J]. 中国感染控制杂志, 2011, 10(2): 156-157, 104.WangJW, WuY, WenAD. A new glycopeptide antibiotic——dalbavancin[J]. Chinese Journal of Infection Control, 2011, 10(2): 156-157, 104. DOI: 10.3969/j.issn.1671-9638.2011.02.023.

22. van GroesenE, InnocentiP, MartinNI. Recent advances in the development of semisynthetic glycopeptide antibiotics: 2014-2022[J]. ACS Infect Dis, 2022, 8(8): 1381-1407. DOI: 10.1021/acsinfecdis.2c00253.

23. BhavnaniSM, OwenJS, LoutitJS, et al. Pharmacokinetics, safety, and tolerability of ascending single intravenous doses of oritavancin administered to healthy human subjects[J]. Diagn Microbiol Infect Dis, 2004, 50(2): 95-102. DOI: 10.1016/j.diagmicrobio.2004.06.007.

24. De LucaJF, HolmesNE, TrubianoJA. Adverse reactions to vancomycin and cross-reactivity with other antibiotics[J]. Curr Opin Allergy Clin Immunol, 2020, 20(4): 352-361. DOI: 10.1097/aci.0000000000000665.

25. ZhanelGG, CalicD, SchweizerF, et al. New lipoglycopeptides: a comparative review of dalbavancin, oritavancin and telavancin[J]. Drugs, 2010, 70(7): 859-886. DOI: 10.2165/11534440-000000000-00000.

26. JonesBM, FreemanKJ, ClevelandKO, et al. Evaluation of dalbavancin in vancomycin allergic patients: a case series[J]. Clin Ther, 2022, 44(12): e59-e63. DOI: 10.1016/j.clinthera.2022.11.006.

27. Shaju AM, PanickerN, ChandniV, et al. Drugs-associated with red man syndrome: an integrative approach using disproportionality analysis and Pharmip[J]. J Clin Pharm Ther, 2022, 47(10): 1650-1658. DOI: 10.1111/jcpt.13716.

28. EroMP, HarveyNR, HarbertJL, et al. Impact of telavancin on prothrombin time and activated partial thromboplastin time as determined using point-of-care coagulometers[J]. J Thromb Thrombolysis, 2014, 38(2): 235-240. DOI: 10.1007/s11239-013-1004-y.

29. HusseinM, BarclayJ, BakerM, et al. A comparative review of the pharmacology of dalbavancin and oritavancin for gram-positive infections: birds of a feather or apples and oranges[J]. Infect Dis Ther, 2025, 14(10): 2221-2246. DOI: 10.1007/s40121-025-01215-1.

30. ParrutiG, PolilliE, ColadonatoS, et al. Safety and efficacy of dalbavancin in real life: retrospective analysis of a large monocentric case series of patients treated for skin/soft tissue and other difficult-to-treat infections[J]. Antibiotics (Basel), 2024, 13(11): 1063. DOI: 10.3390/antibiotics13111063.

31. LundeCS, HartouniSR, JancJW, et al. Telavancin disrupts the functional integrity of the bacterial membrane through targeted interaction with the cell wall precursor lipid II[J]. Antimicrob Agents Chemother, 2009, 53(8): 3375-3383. DOI: 10.1128/aac.01710-08.

32. PolegaJ, BhugraM, VanderhorstD, et al. Real-world use of dalbavancin in a United States tertiary referral center[J]. Cureus, 2025, 17(3): e81505. DOI: 10.7759/cureus.81505.

33. 白帆, 杜小莉. 新型糖肽类抗生素达巴万星[J]. 中国新药杂志, 2015, 24(13): 1441-1444.BaiF, DuXL. Dalbavancin, a novel glycopeptide antimicrobial agent[J]. Chinese Journal of New Drugs, 2015, 24(13): 1441-1444. DOI: 10.20251/j.cnki.1003-3734.2015.13.001.

34. VeveMP, PatelN, SmithZA, et al. Comparison of dalbavancin to standard-of-care for outpatient treatment of invasive Gram-positive infections[J]. Int J Antimicrob Agents, 2020, 56(6): 106210. DOI: 10.1016/j.ijantimicag.2020.106210.

35. TengC, BausC, WilsonJP, et al. Rhabdomyolysis associations with antibiotics: a pharmacovigilance study of the FDA adverse event reporting system (FAERS)[J]. Int J Med Sci, 2019, 16(11): 1504-1509. DOI: 10.7150/ijms.38605.

36. BarriereS, GenterF, SpencerE, et al. Effects of a new antibacterial, telavancin, on cardiac repolarization (QTc interval duration) in healthy subjects[J]. J Clin Pharmacol, 2004, 44(7): 689-695. DOI: 10.1177/0091270004266620.

37. DunneMW, ZhouM, DarpoB. A thorough QT study with dalbavancin: a novel lipoglycopeptide antibiotic for the treatment of acute bacterial skin and skin-structure infections[J]. Int J Antimicrob Agents, 2015, 45(4): 393-398. DOI: 10.1016/j.ijantimicag.2014.12.021.

38. MasonJW, BellibasSE, HuangNY, et al. Electrocardiographic effects of a supratherapeutic dose of oritavancin[J]. Clin Pharmacol Drug Dev, 2016, 5(6): 502-508. DOI: 10.1002/cpdd.268.