Dalbavancin Safety Surveillance: Signal Detection and Analysis from the FDA Adverse Event Reporting System (FAERS)

Dalbavancin Safety Surveillance: Signal Detection and Analysis from the FDA Adverse Event Reporting System (FAERS) | Authorea try { document.documentElement.classList.add('js'); } catch (e) { } var _gaq = _gaq || []; _gaq.push(['_setAccount', 'G-8VDV14Y67G']); _gaq.push(['_trackPageview']); (function() { var ga = document.createElement('script'); ga.type = 'text/javascript'; ga.async = true; ga.src = ('https:' == document.location.protocol ? 'https://ssl' : 'http://www') + '.google-analytics.com/ga.js'; var s = document.getElementsByTagName('script')[0]; s.parentNode.insertBefore(ga, s); })(); Skip to main content Preprints Collections Wiley Open Research IET Open Research Ecological Society of Japan All Collections About About Authorea FAQs Contact Us Quick Search anywhere Search for preprint articles, keywords, etc. Search Search ADVANCED SEARCH SCROLL This is a preprint and has not been peer reviewed. Data may be preliminary. 6 December 2025 V1 Latest version Share on Dalbavancin Safety Surveillance: Signal Detection and Analysis from the FDA Adverse Event Reporting System (FAERS) Authors : Lihua Tian 0009-0009-9396-9593 , Mengzeng , Ping Zou , Jingjie Liao , Qiaoyun Zhang , Qiaoqiao Liu , Yanyuan Li , Yushen Huang , Yazhou Wang [email protected] , and Lingjun Wu Authors Info & Affiliations https://doi.org/10.22541/au.176501715.59359387/v1 162 views 135 downloads Contents Abstract Information & Authors Metrics & Citations View Options References Figures Tables Media Share Abstract Aims: Dalbavancin, a novel lipoglycopeptide antibiotic, is currently approved for treating acute bacterial skin and skin structure infections (ABSSSI), including those caused by methicillin-resistant staphylococcus aureus (MRSA). This pharmacovigilance study analyzed Dalbavancin -associated adverse events (AEs) using real-world data from the FDA Adverse Event Reporting System (FAERS) database, addressing the critical need for post-marketing safety surveillance. Methods: Using FAERS reports from August 2014 to March 2023 (covering Dalbavancin ’s entire post-marketing period), we analyzed Dalbavancin -associated AEs. Disproportionality analyses employed four algorithms: Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and Multi-item Gamma Poisson Shrinker (MGPS). The characteristics of the adverse events were investigated using time-to-onset analysis, the Weibull distribution model, and stratified analysis. Results: A total of 14,787,480 reports listed Dalbavancin as the primary suspect (PS) drug. These yielded 922 Dalbavancin -related AEs comprising 2,257 preferred terms (PTs) across 25 System Organ Classes (SOCs). AE incidence was higher in males (40.56%) than females (35.36%). Most AEs occurred in 2020 (n=133, 14.43%), with serious and non-serious AEs constituting 47.94% and 52.06% of reports. Most AEs occurred within the first treatment month (n=125, 89.29%). Common reactions: rash, pruritus, back pain, erythema, hypersensitivity, vomiting, and urticaria-aligned with prescribing information and clinical trials. Unexpected significant AEs included acute kidney injury, urinary abnormalities, toxic nephropathy, cardiovascular disorders, and sinus tachycardia. Conclusion: This study delivers crucial information to improve its clinical application. Dalbavancin Safety Surveillance: Signal Detection and Analysis from the FDA Adverse Event Reporting System (FAERS) Lihua Tian 1 | Mengzeng An 2 | Lingjun Wu 1 | Ping Zou 1 | Jingjie Liao 1 | Qiaoyun Zhang 1 | Qiaoqiao Liu 1 | Yanyuan Li 1 | Yushen Huang 1 | Yazhou Wang 1 1 Department of Pharmacy, the Fourth Affiliated Hospital of Guangxi Medical University, Liuzhou, China. 2 Department of Hepatopancreatobiliary Surgery, the Fourth Affiliated Hospital of Guangxi Medical University, Liuzhou, China. Correspondence Yazhou Wang, Department of Pharmacy, the Fourth Affiliated Hospital of Guangxi Medical University, Liuzhou, China. E-mail: [email protected] . These authors are co-corresponding authors: Yushen Huang, Department of Pharmacy, the Fourth Affiliated Hospital of Guangxi Medical University, Liuzhou, China. E-mail: [email protected] . These authors contributed equally to this work: Lihua Tian, Mengzeng An. Funding information This work was supported by the China Postdoctoral Science Foundation (NO. 2025MD774067), the Guangxi Natural Science Foundation (No.2023GXNSFBA026334), the Guangxi Young Elite Scientist Sponsorship Program (No.GXYESS2025185) and the Guangxi High-Level Medical Talent Sponsorship Program. Aims: Dalbavancin, a novel lipoglycopeptide antibiotic, is currently approved for treating acute bacterial skin and skin structure infections (ABSSSI), including those caused by methicillin-resistant staphylococcus aureus (MRSA). This pharmacovigilance study analyzed Dalbavancin -associated adverse events (AEs) using real-world data from the FDA Adverse Event Reporting System (FAERS) database, addressing the critical need for post-marketing safety surveillance. Methods: Using FAERS reports from August 2014 to March 2023 (covering Dalbavancin ’s entire post-marketing period), we analyzed Dalbavancin -associated AEs. Disproportionality analyses employed four algorithms: Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and Multi-item Gamma Poisson Shrinker (MGPS). The characteristics of the adverse events were investigated using time-to-onset analysis, the Weibull distribution model, and stratified analysis. Results: A total of 14,787,480 reports listed Dalbavancin as the primary suspect (PS) drug. These yielded 922 Dalbavancin -related AEs comprising 2,257 preferred terms (PTs) across 25 System Organ Classes (SOCs). AE incidence was higher in males (40.56%) than females (35.36%). Most AEs occurred in 2020 (n=133, 14.43%), with serious and non-serious AEs constituting 47.94% and 52.06% of reports. Most AEs occurred within the first treatment month (n=125, 89.29%). Common reactions: rash, pruritus, back pain, erythema, hypersensitivity, vomiting, and urticaria-aligned with prescribing information and clinical trials. Unexpected significant AEs included acute kidney injury, urinary abnormalities, toxic nephropathy, cardiovascular disorders, and sinus tachycardia. Conclusion: This study delivers crucial information to improve its clinical application. Keywords: Dalbavancin ; FAERS; Adverse events; Pharmacovigilance. Introduction Antibiotic resistance is defined as the capacity of bacteria to withstand the inhibitory effects of antibiotics to which they were formerly susceptible. This process is recognized as a natural biological phenomenon. With the use of antibiotics, antibiotic resistance is inevitable [1] . For example, MRSA was initially discovered in China during the 1970s. Following 1980, the proportion of MRSA among isolated S. aureus strains rose to approximately 20%. By 2008, this proportion exceeded 60%, reflecting a rapid increase in MRSA prevalence [2] . Reports indicate significant mortality due to antibiotic resistance globally: 35,000 annual deaths in the European Union alone, over 38,000 per year in Thailand, and 58,000 infant deaths in a single year in India caused by antibiotic-resistant bacterial infections typically transmitted from mothers et al [3] . The escalating threat of antibiotic resistance, coupled with a diminishing therapeutic arsenal, poses a significant challenge to global public health. Without effective intervention, bacterial infections are projected to cause an estimated 10 million annual deaths globally by 2050 [4] . Consequently, developing novel antibiotics remains imperative. Dalbavancin, a semi-synthetic long-acting lipoglycopeptide derived from the teicoplanin-like compound A40926, received FDA approval in May 2014 for treating acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible Gram-positive pathogens in adults [5] . Its mechanism involves disruption of bacterial cell wall synthesis. A structural modification, which is an 11-carbon saturated hydrocarbon chain appended to its sugar moiety, significantly prolongs its half-life ( 6-10 days) and enhances membrane anchoring. This confers superior antibacterial activity against Gram-positive bacteria compared to earlier glycopeptides, with preferential tissue distribution (notably skin/bone) over plasma. These unique pharmacokinetic/pharmacodynamic (PK/PD) properties enable optimized dosing regimens, including two-dose or once-weekly intravenous administration. Consequently, Dalbavancin was subsequently approved for pediatric ABSSSI in 2016 [6,7] . Its distinct PK/PD profile establishes Dalbavancin as a highly effective therapeutic option. Research has shown that lipoglycopeptide antibiotics demonstrate non-inferior efficacy to vancomycin in ABSSSI [8] . Dalbavancin undergoes dual hepatic-renal elimination, requiring no dosage adjustment in hepatic or renal impairment. It exhibits low clinical drug interaction potential, with pharmacokinetics unaffected by age or sex, though weight and renal function may influence exposure [9,10] . The REDS study [11] and an clinical trial in ABSSSI-treated patients [12] reported favorable Dalbavancin safety, with common AEs: general disorders, infusion reactions, hypersensitivity, and dermatological events-aligning with labeling. No treatment-related serious AEs (SAEs) occurred. A meta-analysis by Monteagudo-Martínez et al [13] , incorporating six randomized controlled trials and a large-sample case series (N=3,073) demonstrated Dalbavancin ’s superior safety versus comparators : lower overall AE incidence (30.6% vs. 38.1%; OR 0.79, 95% CI: 0.66–0.94; p=0.01), reduced discontinuations, fewer SAEs, and significantly decreased mortality (OR 0.26, 95% CI: 0.07–0.90; p=0.03). Cumulative evidence supports Dalbavancin ’s strong safety profile, including tolerability in vancomycin-allergic patients [14] . However, the majority of current research on this drug has been limited to post-marketing observations within corresponding patient populations, lacking large-scale, high-sample-size real-world studies. The FAERS is a database designed to support the FDA’s post-marketing monitoring program for drugs and therapeutic biologics approved for marketing. The database contains all AEs and medication error information collected by the FDA [15,16] . Our pharmacovigilance analysis utilizing FAERS data detected significant safety signals associated with Dalbavancin . This study employed four pharmacovigilance methods: ROR and PRR, and Bayesian methods BCPNN and MGPS, leveraging their complementary strengths to enhance signal detection robustness. The non-Bayesian ROR corrects reporting bias with limited data, while PRR prioritizes specificity by excluding certain AEs. Conversely, BCPNN and MGPS offer higher specificity, signal stability, and lower misclassification probability. BCPNN enables early detection despite sparse/missing data, with improving stability as reports accumulate, whereas MGPS excels in identifying rare adverse reactions. Crucially, signals were only deemed significant when meeting all four algorithms’ criteria simultaneously, an approach that expanded verification coverage, and maximized result stability, comprehensiveness, and reliability. This post-marketing safety characterization provides evidence-based guidance for optimizing Dalbavancin clinical management. Data sources The FAERS database is based on the International Safety Reporting Guidelines (ICHE2B) published by ICH. AEs were coded in accordance with the Medical Dictionary for Regulatory Activities (MedDRA) classification system to ensure standardized reporting. The FAERS database is structured into seven distinct data domains: demographic and administrative information (DEMO), adverse drug reactions (REAC), patient outcomes (OUTC), drug/biologic information (DRUG), drug therapy start and end dates (THER), reporting source (RPSR), and indications for use or diagnosis (INDI). Deduplication followed FDA-recommended protocols. For duplicate CASEIDs, the latest FDA_DT entry was prioritized. Temporally overlapping reports retained the highest PRIMARYID [17] . Our analysis included FAERS submissions from August 2014, through March 2025. Data processing We applied FDA-recommended methods to address duplicate reports. The drug name ” Dalbavancin ” was comprehensively retrieved using the MeSH search terms. Only cases with designated Dalbavancin as the “Primary Suspect” were included in the exposure assessment. AEs were coded using PTs from MedDRA version 27.0 within the FAERS database. Data analysis Four disproportionate analysis algorithms, including ROR, PRR, BCPNN, and MGPS [18] , were used to detect potential AE signals related to Dalbavancin . The integration of these four algorithms mitigates the limitations inherent to individual methods and enhances the reliability of the results. AE signals were generated using concurrent positive results across all four detection algorithms. All AE reports in our database were coded with PTs for standardized summarization and analysis, then mapped to corresponding SOC levels within MedDRA v26.0 [19] . Events meeting all four algorithmic criteria were analyzed through pseudotemporal stratification, stratified analysis and Weibull parametric survival modeling. (AEs) that were life-threatening or resulted in hospitalization, disability, or death were classified as serious adverse events (SAEs). The proportion of SAEs was derived from the ratio of SAEs to the total number of AEs. Reports were categorized into SAE and non-SAE groups to evaluate the influence of age and gender on severe outcomes. To ensure analytical rigor, entries with missing sex or age data were excluded from the analysis. SAE incidence was analyzed using Pearson’s χ² test. Association strength was expressed as ORs (95% CIs) [20] . Analyses utilized IBM SPSS v22.0, with α=0.05 significance threshold. Time-to-onset (TTO) (interval from treatment initiation to AE onset) analysis excluded records with temporal inconsistencies. Non-normal TTO distributions were summarized by median and interquartile range (IQR). Results General characteristics. A flowchart of data processing was provided in Fig.1.The clinical characteristics of Dalbavancin related AEs were described in Table 1. A total of 922 AEs were reported in the study. AE reporting rates showed no significant gender-based difference: 35.36% in females versus 40.56% in males. The cohort’s age distribution predominated in the 18-65 year range (24.08%), followed by geriatric patients (>65 years; 18.22%). Serious outcomes included death, life-threatening, hospitalization, disability, and other serious outcomes. Proportional incidence of serious outcomes: hospitalization (n=205, 22.23%), other serious outcomes (n=165, 17.90%), death (n=35, 3.80%), life-threatening conditions (n=33, 3.58%), and disabling outcomes (n=4, 0.43%). Hospitalizations constituted the predominant serious outcome category. The United States accounted for the majority of AE reports (77.87%), followed by France (8.13%), the United Kingdom (3.58%), Italy (3.15%), and Spain (2.60%). Primary AE reporters are primarily submitted by healthcare professionals, including Medical Doctor, Health Professional, Other health-professional. These reported cases constituted the largest proportion (50.22%) of reports, a predominance that enhances pharmacovigilance data credibility. AE reports were predominantly clustered within 2019-2024, with 2020 representing the peak reporting year (n=133; 14.43%). SAEs accounted for 47.94% of cases versus 52.06% non-serious AEs. Figure 1 Flow diagram of this study (DEMO demographic and administrative information, DRUG drug information, REAC preferred terminology for adverse event, PS primary suspect drug) Table 1 Clinical characteristics of reports with Dalbavancin from the FAERS database (August 2014 to March 2025) Number of events 922 Gender Male 374 40.56 Female 326 35.36 Unknown 222 24.08 Age <18 25 2.71 18 ≥ and ≤ 65 222 24.08 ＞65 168 18.22 Unknown 507 54.99 Serious Outcome Hospitalization 205 22.23 Death 35 3.80 Life-Threatening 33 3.58 Disability 4 0.43 Other Outcome 165 17.90 Unknown 480 52.06 Reported Countries (Top five) United States 718 77.87 France 75 8.13 United Kingdom 33 3.58 Italy 29 3.15 Spain 24 2.60 Reported Person Medical Doctor 261 28.31 Pharmacist 248 26.90 Consumer 203 22.02 Health Professional 157 17.03 Other health-professional 45 4.88 Unknown 8 0.87 Reporting year 2025 35 3.80 2024 131 14.21 2023 101 10.95 2022 101 10.95 2021 103 11.17 2020 133 14.43 2019 101 10.95 2018 51 5.53 2017 90 9.76 2016 43 4.66 2015 20 2.17 2014 13 1.41 Serious or non-serious reports Serious 442 47.94 Non-serious 480 52.06 Signal detection The signal strength reports of Dalbavancin at the SOCs level were shown in Figure 2. According to statistics, 25 SOCs were involved in Dalbavancin induced AEs. The top 5 SOCs were general disorders and administration site conditions（n=422,18.70%）, skin and subcutaneous tissue disorders（n=379,16.79%）, injury, poisoning and procedural complications（n=318，14.09%）, gastrointestinal disorders（n=159,7.04%）, respiratory, thoracic and mediastinal disorders（n=134,5.94%）. It was found that the PTs under the 13 SOCs met signal detection criteria, and they were skin and subcutaneous tissue disorders, respiratory, thoracic and mediastinal disorders, musculoskeletal and connective tissue disorders, immune system disorders, gastrointestinal disorders, general disorders and administration site conditions, renal and urinary disorders, injury, poisoning and procedural complications, vascular disorders, infections and infestations, hepatobiliary disorders, blood and lymphatic system disorders, cardiac disorders. We identified 922 Dalbavancin -associated AEs, encompassing 58 PTs spanning 13 SOCs (Table 2). Frequently observed treatment-emergent adverse reactions (rash, pruritus, back pain, erythema, hypersensitivity, vomiting, urticaria) were consistent with the anticipated safety profile described in both prescribing information and established clinical trial data. Meanwhile, the following AEs were identified with their respective metrics: infusion site extravasation (ROR=82.88, PRR=82.12, EBGM=81.77, IC=6.35), bicytopenia (ROR=40.36, PRR=40.31, EBGM=40.23, IC=5.33), infusion site reaction (ROR=31.63, PRR=31.59, EBGM=31.54, IC=4.98), vomiting projectile (ROR=31.49, PRR=31.45, EBGM=31.4, IC=4.97), extravasation (ROR=23.16, PRR=23.13, EBGM=23.11, IC=4.53), flank pain (ROR=22.16, PRR=22.1, EBGM=22.07, IC=4.46), infusion site swelling (ROR=19.79, PRR=19.74, EBGM=19.73, IC=4.3), urine abnormality (ROR=17.24, PRR=17.22, EBGM=17.21, IC=4.11), hyperventilation (ROR=17.23, PRR=17.21, EBGM=17.2, IC=4.1). Additionally, post-marketing surveillance identified statistically significant AEs not described in the prescribing information. They were acute kidney injury （ROR=4.26, PRR=4.22, EBGM=4.22, IC=2.08）, urine abnormality（ROR=17.24, PRR=17.22, EBGM=17.21, IC=4.11）, nephropathy toxic（ROR=7.8, PRR=7.8, EBGM=7.79, IC=2.96）, cardiovascular disorder（ROR=8.09, PRR=8.08, EBGM=8.07, IC=3.01）, sinus tachycardia（ROR=7.11, PRR=7.1, EBGM=7.1, IC=2.83）. Figure 3 displays a forest plot visualizing the distribution of PTs across SOCs. For all SOC-stratified PTs, RORs with 95% confidence intervals exceeding 1, demonstrated statistically significant safety signals, indicating robust drug-event associations. Despite low case frequency for infusion site extravasation (classified under general disorders and administration site conditions SOC), a robust drug-event association was revealed (ROR =82.88, 95% CI =53.88-127.48), demonstrating pronounced signal strength. Although cardiac disorder AEs and sinus tachycardia AEs were infrequent, they demonstrated significant association with Dalbavancin exposure, warranting enhanced clinical vigilance for cardiovascular monitoring. Figure 2 Reports of Dalbavancin at the SOC level. Table 2 Signal strength of reports of Dalbavancin at the System Organ Class (SOC) level in FAERS database. ROR reporting odds ratio, CI confidence interval, PRR proportional reporting ratio, χ2 chi-squared, IC information component, IC 025 the lower limit of 95% CI of the IC, EBGM empirical Bayesian geometric mean, EBGM 05 the lower limit of 95% CI of EBGM. *Indicates statistically significant signals in algorithm Skin and subcutaneous tissue disorders Rash 98 6.11 ( 4.99 - 7.49 ) 5.89 ( 400.87 ) 5.89 ( 4.97 ) 2.56 ( 2.26 ) Pruritus 68 4.92 ( 3.87 - 6.27 ) 4.8 ( 206.11 ) 4.8 ( 3.93 ) 2.26 ( 1.91 ) Erythema 48 6.19 ( 4.65 - 8.24 ) 6.08 ( 204.21 ) 6.07 ( 4.78 ) 2.6 ( 2.19 ) Urticaria 38 6.61 ( 4.8 - 9.11 ) 6.52 ( 177.95 ) 6.52 ( 4.98 ) 2.7 ( 2.24 ) Hyperhidrosis 14 3.22 ( 1.9 - 5.45 ) 3.21 ( 21.31 ) 3.21 ( 2.07 ) 1.68 ( 0.93 ) Blister 10 4.93 ( 2.65 - 9.18 ) 4.92 ( 31.22 ) 4.92 ( 2.92 ) 2.3 ( 1.43 ) Angioedema 9 5.85 ( 3.04 - 11.26 ) 5.83 ( 36.03 ) 5.83 ( 3.37 ) 2.54 ( 1.63 ) Rash macular 7 5.54 ( 2.64 - 11.63 ) 5.52 ( 25.94 ) 5.52 ( 2.97 ) 2.47 ( 1.44 ) Stevens-johnson syndrome 6 10.55 ( 4.73 - 23.52 ) 10.53 ( 51.71 ) 10.52 ( 5.38 ) 3.4 ( 2.3 ) Rash papular 4 5.07 ( 1.9 - 13.51 ) 5.06 ( 13.02 ) 5.06 ( 2.23 ) 2.34 ( 1.05 ) Skin reaction 3 5.83 ( 1.88 - 18.08 ) 5.82 ( 11.97 ) 5.82 ( 2.26 ) 2.54 ( 1.1 ) Toxic skin eruption 3 9.27 ( 2.99 - 28.76 ) 9.26 ( 22.08 ) 9.25 ( 3.59 ) 3.21 ( 1.77 ) Petechiae 3 8.86 ( 2.86 - 27.51 ) 8.85 ( 20.89 ) 8.85 ( 3.43 ) 3.15 ( 1.7 ) Respiratory, thoracic and mediastinal disorders Dyspnoea 59 2.96 ( 2.29 - 3.84 ) 2.91 ( 74.68 ) 2.91 ( 2.34 ) 1.54 ( 1.16 ) Throat irritation 12 7.55 ( 4.28 - 13.32 ) 7.52 ( 67.84 ) 7.52 ( 4.68 ) 2.91 ( 2.11 ) Throat tightness 10 11.23 ( 6.03 - 20.9 ) 11.18 ( 92.7 ) 11.18 ( 6.64 ) 3.48 ( 2.61 ) Pharyngeal oedema 3 6.91 ( 2.23 - 21.46 ) 6.91 ( 15.15 ) 6.9 ( 2.68 ) 2.79 ( 1.34 ) Hyperventilation 3 17.23 ( 5.55 - 53.5 ) 17.21 ( 45.78 ) 17.2 ( 6.67 ) 4.1 ( 2.66 ) Pharyngeal swelling 3 7.15 ( 2.3 - 22.19 ) 7.14 ( 15.84 ) 7.14 ( 2.77 ) 2.84 ( 1.39 ) Musculoskeletal and connective tissue disorders Back pain 58 7.04 ( 5.43 - 9.14 ) 6.89 ( 292.85 ) 6.88 ( 5.54 ) 2.78 ( 2.4 ) Flank pain 7 22.16 ( 10.55 - 46.56 ) 22.1 ( 140.86 ) 22.07 ( 11.86 ) 4.46 ( 3.44 ) Immune system disorders Hypersensitivity 47 6.95 ( 5.21 - 9.28 ) 6.83 ( 234.34 ) 6.82 ( 5.36 ) 2.77 ( 2.35 ) Anaphylactic reaction 25 13.21 ( 8.91 - 19.6 ) 13.08 ( 278.86 ) 13.07 ( 9.4 ) 3.71 ( 3.14 ) Anaphylactic shock 8 9.6 ( 4.8 - 19.23 ) 9.57 ( 61.4 ) 9.57 ( 5.35 ) 3.26 ( 2.29 ) Anaphylactoid reaction 3 27.95 ( 9 - 86.8 ) 27.92 ( 77.74 ) 27.88 ( 10.8 ) 4.8 ( 3.36 ) Gastrointestinal disorders Vomiting 44 2.79 ( 2.07 - 3.75 ) 2.75 ( 49.35 ) 2.75 ( 2.14 ) 1.46 ( 1.03 ) Lip swelling 7 6.07 ( 2.89 - 12.74 ) 6.05 ( 29.51 ) 6.05 ( 3.25 ) 2.6 ( 1.57 ) Vomiting projectile 3 31.49 ( 10.14 - 97.8 ) 31.45 ( 88.3 ) 31.4 ( 12.16 ) 4.97 ( 3.53 ) General disorders and administration site conditions Pyrexia 34 2.85 ( 2.03 - 4.01 ) 2.83 ( 40.35 ) 2.83 ( 2.13 ) 1.5 ( 1.01 ) Chills 27 6.72 ( 4.6 - 9.83 ) 6.66 ( 129.94 ) 6.65 ( 4.84 ) 2.73 ( 2.19 ) Chest pain 25 4.3 ( 2.9 - 6.37 ) 4.26 ( 62.55 ) 4.26 ( 3.06 ) 2.09 ( 1.52 ) Chest discomfort 24 6.77 ( 4.53 - 10.13 ) 6.71 ( 116.82 ) 6.71 ( 4.79 ) 2.75 ( 2.17 ) Infusion site extravasation 21 82.88 ( 53.88 - 127.48 ) 82.12 ( 1675.72 ) 81.77 ( 57.03 ) 6.35 ( 5.73 ) Swelling face 9 4.11 ( 2.13 - 7.9 ) 4.09 ( 21.06 ) 4.09 ( 2.37 ) 2.03 ( 1.12 ) Feeling hot 9 4.5 ( 2.34 - 8.67 ) 4.49 ( 24.43 ) 4.49 ( 2.6 ) 2.17 ( 1.25 ) Injection site extravasation 7 14.84 ( 7.06 - 31.17 ) 14.8 ( 90 ) 14.79 ( 7.95 ) 3.89 ( 2.86 ) Infusion site pain 6 11.26 ( 5.05 - 25.1 ) 11.23 ( 55.92 ) 11.23 ( 5.74 ) 3.49 ( 2.4 ) Feeling cold 6 6.27 ( 2.81 - 13.96 ) 6.25 ( 26.47 ) 6.25 ( 3.2 ) 2.64 ( 1.55 ) Infusion site swelling 5 19.79 ( 8.22 - 47.6 ) 19.74 ( 88.89 ) 19.73 ( 9.46 ) 4.3 ( 3.12 ) Extravasation 3 23.16 ( 7.46 - 71.92 ) 23.13 ( 63.45 ) 23.11 ( 8.95 ) 4.53 ( 3.09 ) Infusion site reaction 3 31.63 ( 10.18 - 98.23 ) 31.59 ( 88.71 ) 31.54 ( 12.22 ) 4.98 ( 3.53 ) Infusion site erythema 3 8.96 ( 2.89 - 27.82 ) 8.95 ( 21.18 ) 8.95 ( 3.47 ) 3.16 ( 1.72 ) Renal and urinary disorders Acute kidney injury 31 4.26 ( 2.99 - 6.08 ) 4.22 ( 76.33 ) 4.22 ( 3.13 ) 2.08 ( 1.56 ) Urine abnormality 3 17.24 ( 5.55 - 53.54 ) 17.22 ( 45.81 ) 17.21 ( 6.67 ) 4.11 ( 2.66 ) Nephropathy toxic 3 7.8 ( 2.51 - 24.22 ) 7.8 ( 17.77 ) 7.79 ( 3.02 ) 2.96 ( 1.52 ) Injury, poisoning and procedural complications Infusion related reaction 27 11.16 ( 7.63 - 16.31 ) 11.04 ( 246.54 ) 11.03 ( 8.03 ) 3.46 ( 2.91 ) Vascular disorders Flushing 15 5.31 ( 3.2 - 8.82 ) 5.28 ( 52.11 ) 5.28 ( 3.45 ) 2.4 ( 1.68 ) Pallor 7 7.58 ( 3.61 - 15.91 ) 7.56 ( 39.82 ) 7.55 ( 4.06 ) 2.92 ( 1.9 ) Cyanosis 5 11.21 ( 4.66 - 26.96 ) 11.18 ( 46.35 ) 11.18 ( 5.36 ) 3.48 ( 2.3 ) Infections and infestations Cellulitis 13 7.33 ( 4.25 - 12.64 ) 7.29 ( 70.57 ) 7.29 ( 4.62 ) 2.87 ( 2.09 ) Osteomyelitis 4 6.65 ( 2.49 - 17.74 ) 6.64 ( 19.17 ) 6.64 ( 2.92 ) 2.73 ( 1.44 ) Hepatobiliary disorders Cholestasis 5 7.79 ( 3.24 - 18.74 ) 7.78 ( 29.52 ) 7.77 ( 3.73 ) 2.96 ( 1.78 ) Hepatic cytolysis 3 6.47 ( 2.08 - 20.07 ) 6.46 ( 13.84 ) 6.46 ( 2.5 ) 2.69 ( 1.25 ) Blood and lymphatic system disorders Eosinophilia 5 8.36 ( 3.48 - 20.11 ) 8.35 ( 32.32 ) 8.34 ( 4 ) 3.06 ( 1.88 ) Leukocytosis 3 5.29 ( 1.71 - 16.43 ) 5.29 ( 10.43 ) 5.29 ( 2.05 ) 2.4 ( 0.96 ) Bicytopenia 3 40.36 ( 12.99 - 125.4 ) 40.31 ( 114.77 ) 40.23 ( 15.58 ) 5.33 ( 3.88 ) Cardiac disorders Cardiovascular disorder 4 8.09 ( 3.03 - 21.58 ) 8.08 ( 24.8 ) 8.07 ( 3.55 ) 3.01 ( 1.72 ) Sinus tachycardia 3 7.11 ( 2.29 - 22.07 ) 7.1 ( 15.73 ) 7.1 ( 2.75 ) 2.83 ( 1.38 ) Figure 3 Forest plot of the preferred terms (PT) under different system organ classifications (SOC). Onset time of events TTO for Dalbavancin -associated AEs was obtained from the database. After excluding inaccurate, undocumented, or unverifiable reports, 140 AEs had documented TTO data. As depicted in Figure 4, the majority of AEs (n=125, 89.29%) manifested within the first month of Dalbavancin therapy. Incidence decreased significantly to 8.57% (n=12, 8.57%) during month 2, approaching baseline levels (0-0.71%) beyond month 3. This temporal pattern aligns with Weibull distribution modeling (β parameter analysis, Table 3). These findings demonstrated Dalbavancin ’s favorable long-term safety profile. Vigilant monitoring for potential adverse reactions during the initial treatment month remains essential. Figure 4 Time to onset of AEs with Dalbavancin as the primary suspected drug. Table 3 Weibull shape parameter test. shape parameter：β 0.68 0.61-0.75 scale parameter：α 11.64 8.62-14.65 Type Early failure Serious and non-serious adverse event reports This study documented 442 SAEs (47.94%) and 480 NSAEs(52.06%). Through subgroup analysis of gender and age (Table 4), SAEs occurred more frequently in males (58.5%) versus females (41.5%), with significantly increased male risk (OR =1.584, 95% CI =1.173-2.139; p=0.003). Additionally, geriatric patients (≥65 years) experienced higher SAE incidence than younger counterparts (52.9% vs. 47.1%), demonstrating significantly elevated risk (OR= 2.638, 95% CI =1.759-3.956; p<0.001). Table 4 Comparison of patient sex and age between serious and non-serious reports. OR: Odds Ratio. CI: Confidential Interval Gender Female (Reference) 160/166 Male 226/148 0.003 1.584 (1.173 - 2.139) Age ≤ 65 (Reference) 104/136 > 65 117/58 < 0.001 2.638 (1.759 - 3.956) Discussion Current real-world evidence regarding Dalbavancin safety remains limited. Leveraging the FAERS database, This study characterized the post-marketing safety signals associated with Dalbavancin exposure. Utilizing large-scale pharmacovigilance analytics, this study detected statistically significant safety signals associated with Dalbavancin . This real-world pharmacovigilance study provides robust evidence supporting the clinical safety profile of Dalbavancin . Dalbavancin was approved for two dosing regimens: single-dose or double-dose. They were : 1500 mg via single intravenous infusion (over 30 minutes), or 1000 mg IV followed by 500 mg IV one week later in adults [21] . Dalbavancin represents a valuable therapeutic alternative to daily IV therapy or outpatient antimicrobial regimens, effectively simplifying treatment protocols and facilitating expedited discharge eligibility [22] . A prospective observational study utilizing the Canadian CLEAR registry [23] documented intravenous Dalbavancin administration patterns. Clinical applications encompassed both targeted therapy and empirical antimicrobial treatment for ABSSSI, with off-label use extending to osteoarticular infections, bacteremia, vascular infections, and infective endocarditis. The dataset encompassed both outpatient and inpatient populations. Results demonstrated Dalbavancin ’s high microbiological eradication rates, superior clinical cure rates, and favorable safety profile. Its single-dose regimen streamlined therapy and enabled expedited hospital discharge. Studies have demonstrated that variations in initial dosing and administration regimens significantly modulate treatment efficacy and AE incidence [24] . Furthermore, a comparative clinical study found Dalbavancin had comparable efficacy to standard antimicrobial regimens in treating complex infections, with similar safety and tolerability profiles between the two therapeutic approaches [25] . Dalbavancin thus offers not only convenience but also well-established efficacy. Notably, our study shows that both infusion-related adverse events and administration site conditions as robust safety signals, which include: infusion site extravasation, infusion site reaction, extravasation, infusion site swelling, injection site extravasation, infusion site pain, infusion related reaction, infusion site erythema. Despite limited case numbers, discernible associations with Dalbavancin -related AEs were observed. This finding confirms alignment with the prescribing information. Consequently, vigilant monitoring for these AEs is necessary during intravenous Dalbavancin administration. Dalbavancin exhibited gradual accumulation with repeated administration. A long-term clinical study has confirmed no renal impairment [26] . Dalbavancin demonstrated a favorable renal safety profile, requiring no dosage adjustment in mild-to-moderate renal impairment (eGFR >30 mL/min/1.73 m²). Nephrotoxicity is not mentioned in the prescribing information. However, González et al. [8] reported nephrotoxicity in patients with ABSSSI receiving intravenous Dalbavancin in three pivotal clinical trials, where nephrotoxicity was observed in 3.7% of Dalbavancin recipients versus 9.3% of vancomycin recipients (P = 0.039), highlighting its renal safety advantage. Our study identified treatment-emergent renal AEs, including acute kidney injury, urinary abnormalities, and nephrotoxicity, associated with Dalbavancin . Furthermore, age-stratified analysis revealed increased AEs risk in ≥65 years cohort; the incidence of these AEs was significantly higher in geriatric patients compared to younger cohorts. We postulate that this may be attributable to the predominantly renally clearance of Dalbavancin [27] . Given the higher prevalence of declining renal function and increased susceptibility to renal impairment in older adults, this risk is particularly relevant for geriatric populations. Consequently, cautious therapeutic management and monitoring are warranted in older patients. Meanwhile, larger prospective studies are warranted to monitor and elucidate the potential nephrotoxicity of Dalbavancin, thereby guiding clinical management. Analysis of the data revealed a statistically significant association between Dalbavancin exposure and cardiovascular disorders, including cardiovascular disorders（N=4, ROR=8.09, PRR=8.08, EBGM=8.07, IC=3.01）, and sinus tachycardia（N=3, ROR=7.11, PRR=7.1, EBGM=7.1, IC=2.83）, notwithstanding limited case reports. Currently, no conclusive evidence establishes a direct causal relationship between Dalbavancin exposure and cardiovascular toxicity. Our finding suggests that cardiovascular disorders warrant vigilance during Dalbavancin administration, ensuring the safety of clinical use. Furthermore, pseudotemporal trajectory analysis demonstrated that most Dalbavancin -associated AEs manifest within 30 days post-treatment initiation. To evaluate temporal changes in the risk of Dalbavancin -related AEs, we analyzed the Weibull shape parameter in the overall patient cohort. We exclusively focused on the shape parameter β. Analysis revealed a derived β value of 0.68, with 95% CI of 0.75. Both values were below 1, indicating a decreasing prevalence of AEs over time [28] . Therefore, based on its sustained therapeutic concentrations and favorable safety profile, Dalbavancin may offer superior tolerability for prolonged treatment courses. Dalbavancin ’s proven efficacy and safety are driving expanded off-label use for infections including bacteremia, infective endocarditis, and complicated healthcare-associated infections spanning osteomyelitis, prosthetic joint infections, surgical site infections, and septic arthritis [29–33] . However, clinical cure rates vary across different infection types [34] . Studies have even identified its antiviral activity in vitro [35] , and the safety profile of Dalbavancin in pediatric patients with ABSSSI remains consistent with that in adults, with no novel safety signals detected [36] . Furthermore, population pharmacokinetic analyses [37] substantiated Dalbavancin dosing recommendations across diverse patient populations, including those with significant weight variations and renal impairment, aligning with our study’s implication for enhanced monitoring in patients >65 years. Additional studies confirm Dalbavancin ’s safety and efficacy in heterogeneous populations [38] . Nevertheless, studies [39–42] indicated that specific disease states may alter Dalbavancin ’s pharmacokinetics, potentially compromising sustained achievement of pharmacokinetic/pharmacodynamic (PK/PD) targets over time, which could contribute to treatment failure in certain clinical scenarios. Current evidence sources exhibit biases limiting generalizability. Our statistical analysis did not account for the potential impact of body weight, dosing regimen, or other covariates on Dalbavancin safety outcomes. More real-world studies evaluating both approved and off-label indications are necessary to comprehensively characterize Dalbavancin ’s safety. Incorporating our findings, vigilance is required for both commonly documented AEs and unexpected reactions identified here but absent from prescribing information. Emerging threats of Dalbavancin resistance warrant vigilant monitoring. Enhanced surveillance of determinants contributing to Dalbavancin resistance is critical for optimizing therapeutic outcomes [43–45] . Conclusion This pharmacovigilance study utilized the FAERS database to characterize significant AE signals and evaluate the post-marketing safety of Dalbavancin, thereby providing insights into its clinical manifestations. Commonly reported AEs included rash, pruritus, dorsalgia, erythema, hypersensitivity reactions, vomiting, and urticaria. Clinicians must monitor for infusion-related reactions during intravenous Dalbavancin administration. We also identified unexpected AE signals not described in the prescribing information, warranting further evaluation. Enhanced AE monitoring during the initial treatment month, particularly in special populations, is crucial, with heightened vigilance for events associated with unlabeled indications. Nonetheless, further studies are required to validate known and identify novel Dalbavancin -associated AEs, thereby optimizing clinical guidance for both approved and extralabel indications. AUTHOR CONTRIBUTIONS All authors critically reviewed and approved the manuscript for submission in addition to the contributions listed below. LT, MA, YW and YH contributed substantially to the study design and concept, data interpretation and manuscript preparation. LT, MA, LW and PZ conducted the data analyses. JL and QZ made the relative statistics. MA, QL and YL performed the data curation. LT drafted the manuscript and collected the references. YH and YW revised the manuscript. YH provided conceptualization and financial support, supervision writing. ACKNOWLEDGEMENTS This study was performed using the FAERS database provided by the FDA. The information, results, or interpretation of the current study do not represent any opinion of the FDA. CONFLICT OF INTEREST STATEMENT The authors declare no conflict of interest. DATA AVAILABILITY STATEMENT This study analyzed publicly available datasets, which can be accessed here: [https://fis.fda.gov/extensions/FPD-QDE-FAERS/FPD-QDE-FAERS.html]. REFERENCES [1] Poudel A N, Zhu S, Cooper N, et al. The economic burden of antibiotic resistance: a systematic review and meta-analysis[J]. PLOS One, 2023, 18(5): e0285170.[2] Xiao Y H, Giske C G, Wei Z Q, et al. Epidemiology and characteristics of antimicrobial resistance in China[J]. Drug Resistance Updates, 2011, 14(4): 236-250.[3] Khan R T, Sharma V, Khan S S, et al. Prevention and potential remedies for antibiotic resistance: current research and future prospects[J]. Frontiers in Microbiology, 2024, 15: 1455759.[4] Luo Q, Lu P, Chen Y, et al. ESKAPE in China: epidemiology and characteristics of antibiotic resistance[J]. Emerging Microbes & Infections, 2024, 13(1): 2317915.[5] Ramdeen S, Boucher H W. Dalbavancin for the treatment of acute bacterial skin and skin structure infections[J]. Expert Opinion on Pharmacotherapy, 2015, 16(13): 2073.[6] Barberán J, Cuerda A de la, Barberán L C. Dalbavancin [J]. Revista Española De Quimioterapia, 2021, 34(Suppl1): 26.[7] Caselli D, Aricò M, Castagnola E, et al. Bridging the gap: a systematic review with expert opinion on the use of Dalbavancin for In-label and off-label indications in pediatric patients[J]. Antibiotics (Basel, Switzerland), 2025, 14(2): 121.[8] Gonzalez P L, Rappo U, Mas Casullo V, et al. Safety of Dalbavancin in the treatment of acute bacterial skin and skin structure infections (ABSSSI): nephrotoxicity rates compared with vancomycin: a post hoc analysis of three clinical trials[J]. Infectious Diseases and Therapy, 2021, 10(1): 471-481.[9] Buckwalter M, Dowell J A. Population pharmacokinetic analysis of Dalbavancin, a novel lipoglycopeptide[J]. The Journal of Clinical Pharmacology, 2005, 45(11): 1279-1287.[10] Hervochon C, Hennart B, Leroy A-G, et al. Dalbavancin plasma concentrations in 133 patients: a PK/PD observational study[J]. journal of antimicrobial chemotherapy,2023,12(78):2919–2925. [11] Papavramidis T, Gentile I, Cattelan A M, et al. REDS study: Retrospective effectiveness study of Dalbavancin and other standard of care of the same IV antibiotic class in patients with ABSSSI[J]. International Journal of Antimicrobial Agents, 2023, 61(4): 106746.[12] Righi E, Visentin A, Meroi M, et al. Dalbavancin in the treatment of acute bacterial skin and skin structure and other infections: a safety evaluation[J]. Expert Opinion on Drug Safety, 2022, 21(9): 1171-1181.[13] Monteagudo-Martínez N, Solís-García Del Pozo J, Ikuta I, et al. Systematic review and meta-analysis on the safety of Dalbavancin [J]. Expert Opinion on Drug Safety, 2021, 20(9): 1095-1107.[14] Jones B M, Freeman K J, Cleveland K O, et al. Evaluation of Dalbavancin in Vancomycin Allergic Patients: A Case Series[J]. Clinical Therapeutics, 2022, 44(12): e59-e63.[15] Wang B, Zhao K, Xian N, et al. Adverse events associated with vismodegib: insights from a real-world pharmacovigilance study using the FAERS database[J]. Frontiers in Pharmacology, 2025, 16: 1497708.[16] Zhao K, Xiao S, Zhao Y, et al. Comprehensive post-marketing safety analysis of tildrakizumab: insights from the FDA adverse event reporting system[J]. Expert Opinion on Drug Safety, 2025: 1-8.[17] Shu Y, Ding Y, He X, et al. Hematological toxicities in PARP inhibitors: a real-world study using FDA adverse event reporting system (FAERS) database[J]. Cancer Medicine, 2023, 12(3): 3365-3375.[18] Wang M, Yang Z, Yan M, et al. Depression and suicide/self-injury signals for weight loss medications: a disproportionality analysis of semaglutide, liraglutide, and tirzepatide in FAERS database[J]. Journal of Affective Disorders, 2025: 119670.[19] Zhou Q, Du Z, Qu K, et al. Adverse events of epidiolex: a real-world drug safety surveillance study based on the FDA adverse event reporting system (FAERS) database[J]. Asian Journal of Psychiatry, 2023, 90: 103828.[20] Mazhar F, Battini V, Gringeri M, et al. The impact of anti-TNFα agents on weight-related changes: new insights from a real-world pharmacovigilance study using the FDA adverse event reporting system (FAERS) database[J].expert opinion on biological therapy, 2021,21(9):1281-1290. [21] Billeter M, Zervos M J, Chen A Y, et al. Dalbavancin : a novel once-weekly lipoglycopeptide antibiotic[J]. Clinical Infectious Diseases: an Official Publication of the Infectious Diseases Society of America, 2008, 46(4): 577-583.[22] Rebold N, Alosaimy S, Pearson J C, et al. Dalbavancin Sequential Therapy for Gram-Positive Bloodstream Infection: A Multicenter Observational Study[J]. Infectious Diseases and Therapy, 2024, 13(3): 565-579.[23] Zhanel G, Silverman M, Malhotra J, et al. Real-life experience with IV Dalbavancin in Canada; results from the CLEAR (Canadian LEadership on Antimicrobial Real-life usage) registry[J]. Journal of Global Antimicrobial Resistance, 2024, 38: 154-157.[24] Parruti G, Polilli E, Coladonato S, 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, Switzerland), 2024, 13(11): 1063.[25] Steuber T D, Gipson H, Boyett B, et al. Head-to-head comparison of multi-dose oritavancin and Dalbavancin for complicated infections: a propensity score-matched analysis[J]. International Journal of Antimicrobial Agents, 2024, 63(6): 107165.[26] Söderquist B, Möller M, Salihovic S. Trough levels of Dalbavancin during long-term treatment of prosthetic joint infections[J]. Infectious Diseases (london, England), 2025: 1-7.[27] Molina K C, Miller M A, Mueller S W, et al. Clinical pharmacokinetics and pharmacodynamics of Dalbavancin [J]. Clinical Pharmacokinetics, 2022, 61(3): 363-374.[28] Sauzet O, Carvajal A, Escudero A, et al. Illustration of the weibull shape parameter signal detection tool using electronic healthcare record data [J]. drug safety, 2013, 36(10):995-1006. [29] Leanza G M, Rando E, Frondizi F, et al. A systematic review of Dalbavancin efficacy as a sequential therapy for infective endocarditis[J]. Infection, 2025, 53(1): 15-23.[30] Hidalgo-Tenorio C, Sadyrbaeva-Dolgova S, Aparicio-Minguijón E, et al. Real-world evidence of Dalbavancin effectiveness as consolidation therapy in infective endocarditis due to enterococcus spp[J]. Journal of Microbiology, Immunology, and Infection = Wei Mian Yu Gan Ran Za Zhi, 2025: S1684-1182(25)44-1.[31] Chiriac U, Liebchen U, Frey O R, et al. Model-based dose identification of Dalbavancin for long-term suppressive outpatient treatment of ventricular assist device infections[J]. Antibiotics (Basel, Switzerland), 2024, 13(11): 1103.[32] Esposito S, Pagliano P, De Simone G, et al. In-label, off-label prescription, efficacy and tolerability of Dalbavancin : report from a national registry[J]. Infection, 2024, 52(4): 1297-1306.[33] De Vito A, Fiore V, Colpani A, et al. The current and future off-label uses of Dalbavancin : a narrative review[J]. European Review for Medical and Pharmacological Sciences, 2023,27(3):1222-1238.[34] McSorley J C, Reyes D, Tonna I, et al. Experience with Dalbavancin use in various gram-positive infections within Aberdeen Royal Infirmary OPAT service[J]. Infection, 2024, 52(2): 567-576.[35] Wang G, Yang M L, Duan Z L, et al. Dalbavancin binds ACE2 to block its interaction with SARS-CoV-2 spike protein and is effective in inhibiting SARS-CoV-2 infection in animal models[J]. Cell Research, 2021, 31(1): 17-24.[36] Giorgobiani M, Burroughs M H, Antadze T, et al. The safety and efficacy of Dalbavancin and active comparator in pediatric patients with acute bacterial skin and skin structure infections[J]. Pediatric Infectious Disease Journal, 2023, 42(3): 199-205.[37] Baiardi G, Cameran Caviglia M, Boni S, et al. Multidose Dalbavancin population pharmacokinetic analysis for prolonged target attainment in patients requiring long-term treatment[J]. Antibiotics (Basel, Switzerland), 2025, 14(2): 190.[38] Sobrino B, Luque S, Velasco-Arnaiz E, et al. Gram-positive infections in special populations. Expert view on the role of Dalbavancin [J]. Expert Review of Anti-Infective Therapy, 2025, 23(5): 265-275.[39] Oliva A, Petrucci F, Leanza C, et al. Using Dalbavancin for the treatment of acute bacterial skin and skin structure infections (ABSSSIs) in obese patients: a real-life, single-center observational study[J]. Antibiotics (Basel, Switzerland), 2025, 14(1): 75.[40] Morata Ruiz L, Ruggieri A, Falcone M, et al. Dalbavancin real-life utilization among diabetic patients suffering from infections in Italy and Spain: The DALBADIA retrospective cohort study[J]. Journal of Global Antimicrobial Resistance, 2024, 36: 200-209.[41] Cafaro A, Baiardi G, Mesini A, et al. Dalbavancin pharmacokinetics in an 18-month-old child undergoing extracorporeal membrane oxygenation: a short communication[J]. Therapeutic Drug Monitoring, 2025.[42] Mazzitelli M, Mengato D, Scaglione V, et al. Clinical, microbiological and laboratory predictors of on- and off-label Dalbavancin treatment failure[J]. Journal of Global Antimicrobial Resistance, 2025: S2213-7165(25)117-1.[43] Tebano G, Zaghi I, Baldasso F, et al. Antibiotic resistance to molecules commonly prescribed for the treatment of antibiotic-resistant gram-positive pathogens: what is relevant for the clinician?[J]. Pathogens (basel, Switzerland), 2024, 13(1): 88.[44] Galfo V, Tiseo G, Riccardi N, et al. Therapeutic drug monitoring of antibiotics for methicillin-resistant staphylococcus aureus infections: an updated narrative review for clinicians[J]. Clinical Microbiology and Infection: the Official Publication of the European Society of Clinical Microbiology and Infectious Diseases, 2025, 31(2): 194-200.[45] Cattaneo D, Fusi M, Colaneri M, et al. Therapeutic drug monitoring of Dalbavancin in real life: a two-year experience[J]. Antibiotics (Basel, Switzerland), 2023, 13(1): 20. Information & Authors Information Version history V1 Version 1 06 December 2025 Copyright This work is licensed under a Non Exclusive No Reuse License. Authors Affiliations Lihua Tian 0009-0009-9396-9593 Liuzhou Workers' Hospital View all articles by this author Mengzeng Liuzhou Workers' Hospital View all articles by this author Ping Zou Liuzhou Workers' Hospital View all articles by this author Jingjie Liao Liuzhou Workers' Hospital View all articles by this author Qiaoyun Zhang Liuzhou Workers' Hospital View all articles by this author Qiaoqiao Liu Liuzhou Workers' Hospital View all articles by this author Yanyuan Li Liuzhou Workers' Hospital View all articles by this author Yushen Huang Liuzhou Workers' Hospital View all articles by this author Yazhou Wang [email protected] Liuzhou Workers' Hospital View all articles by this author Lingjun Wu Fourth Affiliated Hospital of Guangxi Medical University View all articles by this author Metrics & Citations Metrics Article Usage 162 views 135 downloads .FvxKWukQNSOunydq8rnd { width: 100px; } Citations Download citation Lihua Tian, Mengzeng, Ping Zou, et al. Dalbavancin Safety Surveillance: Signal Detection and Analysis from the FDA Adverse Event Reporting System (FAERS). Authorea . 06 December 2025. DOI: https://doi.org/10.22541/au.176501715.59359387/v1 If you have the appropriate software installed, you can download article citation data to the citation manager of your choice. Simply select your manager software from the list below and click Download. For more information or tips please see 'Downloading to a citation manager' in the Help menu . Format Please select one from the list RIS (ProCite, Reference Manager) EndNote BibTex Medlars RefWorks Direct import Tips for downloading citations document.getElementById('citMgrHelpLink').addEventListener('click', function() { popupHelp(this.href); return false; }); $(".js__slcInclude").on("change", function(e){ if ($(this).val() == 'refworks') $('#direct').prop("checked", false); $('#direct').prop("disabled", ($(this).val() == 'refworks')); }); View Options View options PDF View PDF Figures Tables Media Share Share Share article link Copy Link Copied! Copying failed. Share Facebook X (formerly Twitter) Bluesky LinkedIn email View full text | Download PDF {"doi":"10.22541/au.176501715.59359387/v1","type":"Article"} Now Reading: Share Figures Tables Close figure viewer Back to article Figure title goes here Change zoom level Go to figure location within the article Download figure Toggle share panel Toggle share panel Share Toggle information panel Toggle information panel Go to previous graphic Go to next graphic Go to previous table Go to next table All figures All tables View all material View all material xrefBack.goTo xrefBack.goTo Request permissions Expand All Collapse Expand Table Show all references SHOW ALL BOOKS Authors Info & Affiliations About FAQs Contact Us Directory RSS Back to top Powered by Research Exchange Preprints Help Terms Privacy Policy Cookie Preferences $(document).ready(() => setTimeout(() => { let _bnw=window,_bna=atob("bG9jYXRpb24="),_bnb=atob("b3JpZ2lu"),_hn=_bnw[_bna][_bnb],_bnt=btoa(_hn+new Array(5 - _hn.length % 4).join(" ")); $.get("/resource/lodash?t="+_bnt); },4000)); (function(){function c(){var b=a.contentDocument||a.contentWindow.document;if(b){var d=b.createElement('script');d.innerHTML="window.__CF$cv$params={r:'9fe8cd1fdb57e2c5',t:'MTc3OTI1MzQ3Mw=='};var a=document.createElement('script');a.src='/cdn-cgi/challenge-platform/scripts/jsd/main.js';document.getElementsByTagName('head')[0].appendChild(a);";b.getElementsByTagName('head')[0].appendChild(d)}}if(document.body){var a=document.createElement('iframe');a.height=1;a.width=1;a.style.position='absolute';a.style.top=0;a.style.left=0;a.style.border='none';a.style.visibility='hidden';document.body.appendChild(a);if('loading'!==document.readyState)c();else if(window.addEventListener)document.addEventListener('DOMContentLoaded',c);else{var e=document.onreadystatechange||function(){};document.onreadystatechange=function(b){e(b);'loading'!==document.readyState&&(document.onreadystatechange=e,c())}}}})();