Musculoskeletal adverse events associated with bempedoic acid: a real-world pharmacovigilance study.

Introduction: Linezolid is an oxazolidinone antibiotic that is active against drug-resistant Gram-positive bacteria and multidrug-resistant Mycobacterium tuberculosis. Real-world studies on the safety of linezolid in large populations are lacking. This study aimed to determine the adverse events associated with linezolid in real-world settings by analyzing data from the US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS). Methods: We retrospectively extracted reports on adverse drug events (ADEs) from the FAERS database from the first quarter of 2004 to that of 2023. By using disproportionality analysis including reporting odds ratio (ROR), proportional reporting ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), along with the multi-item gamma Poisson shrinker (MGPS), we evaluated whether there was a significant association between linezolid and ADE. The time to onset of ADE was further analyzed in the general population and within each age, weight, reporting population, and weight subgroups. Results: A total of 11,176 reports of linezolid as the "primary suspected" drug and 263 significant adverse events of linezolid were identified, including some common adverse events such as thrombocytopenia (n = 1,139, ROR 21.98), anaemia (n = 704, ROR 7.39), and unexpected signals that were not listed on the drug label such as rhabdomyolysis (n = 90, ROR 4.33), and electrocardiogram QT prolonged (n = 73, ROR 4.07). Linezolid-induced adverse reactions involved 27 System Organ Class (SOC). Gender differences existed in ADE signals related to linezolid. The median onset time of all ADEs was 6 days, and most ADEs (n = 3,778) occurred within the first month of linezolid use but some may continue to occur even after a year of treatment (n = 46). Conclusion: This study reports the time to onset of adverse effects in detail at the levels of SOC and specific preferred term (PT). The results of our study provide valuable insights for optimizing the use of linezolid and reducing potential side effects, expected to facilitate the safe use of linezolid in clinical settings.

A Real-World Disproportionality Analysis of FDA Adverse Event Reporting System(FAERS) Event for Belatacept.

The bempedoic acid plus ezetimibe fixed-dose combination (BAPEFC) is a novel lipid-lowering agent that was successively marketed in regions such as the United States and the European Union in 2020. It significantly reduces low-density lipoprotein cholesterol through a dual mechanism of inhibiting adenosine triphosphate-citrate lyase and Niemann-Pick C1-like 1. Although clinical trials have confirmed its efficacy, its long-term safety in the real world requires further evaluation. All adverse event reports related to BAPEFC from the first quarter of 2020 to the first quarter of 2025 were extracted from the FDA Adverse Event Reporting System (FAERS) database. After data standardization, a comprehensive evaluation of adverse reaction signals was performed using the reporting odds ratio (ROR), proportional reporting ratio, Bayesian confidence propagation neural network, and multi-item gamma Poisson shrinker methods. Subgroup analyses by sex and age were further conducted for newly identified adverse drug reactions. A total of 875 reports involving at least 1 BAPEFC agent were identified in FAERS. The preferred term with the highest number of reports was arthralgia (n = 103), while the strongest positive signal was for tendon discomfort (n = 3, ROR = 135.27, proportional reporting ratio = 135.03, information component = 7.06, empirical Bayes geometric mean = 133.36). At the system organ class level, musculoskeletal and connective tissue disorders had the highest ROR value (ROR = 6.02, 95% confidence interval [CI]: 5.46-6.63). The newly identified signal for "Blood Triglycerides Increased" showed statistically significant ROR signals in both male and female subgroups (ROR = 36.59 [95% CI: 15.16-88.32] vs ROR = 34.78 [95% CI: 15.57-77.67]), and the adjusted Bonferroni-P values were statistically significant (Bonferroni-P < .0001). Subgroup analysis of the combined data for the newly identified "Pancreatitis" and "Pancreatitis Acute" showed statistically significant ROR signals in both the non-elderly subgroup (<65 years) and the elderly subgroup (≥65 years) (ROR = 10.43 [95% CI: 4.32-25.18] vs ROR = 5.88 [95% CI: 2.2-15.71]), and the adjusted Bonferroni-P values were statistically significant (Bonferroni-P = .0003 vs Bonferroni-P = .0106). Based on the FAERS database, this study provides the first comprehensive and systematic analysis of adverse drug events associated with BAPEFC. It newly identifies several adverse drug reactions not mentioned in the prescribing information, such as blood triglycerides increased, pancreatitis, and pancreatitis acute, thereby offering evidence for clinical monitoring and identification of potential risks associated with BAPEFC.

Baclofen is a muscle relaxant that could carry the risk for neurological adverse events (nAEs). We aim to analyze the nAE profile of frequently used baclofen for its clinical application. Our research is a disproportional analysis based on the FDA Adverse Event Reporting System (FAERS) database. We obtained adverse event reports of baclofen from January 2004 to June 2023 from the FAERS database. Reporting odds ratio (ROR) and Bayesian confidence propagation neural network (BCPNN) were performed to find nAE associated with baclofen. We extracted a total of 9305 nAE cases with baclofen as the primary suspect. The patients were mostly under 18 years old (45.49%), with markedly more males (43.72%) than females (36.52%). In all, 7275 (78.18%) reports were from the United States. There were 2023 of 9305 (21.74%) reports that occurred serious adverse events (SAE). The median onset time of reports with baclofen-related nAE was 10 days (interquartile range (IQR) 1-112). Intrathecal injection (75.78%) was more than oral (23.06%). We detected 119 significant signals, among which the higher frequencies were somnolence (ROR: 4.69, 95% CI (4.37, 5.03); IC: 2.17, IC025 (2.06)), tremor (ROR: 2.76, 95% CI (2.50, 3.04); IC: 1.43, IC025 (1.29)), lethargy (ROR: 6.37, 95% CI (5.71, 7.10); IC: 2.61, IC025 (2.45)), status epilepticus (ROR: 8.71, 95% CI (7.07, 10.73); IC: 2.98, IC025 (2.69)), generalized tonic-clonic seizure (ROR: 3.17, 95% CI (2.54,3.95); IC: 1.62, IC025 (1.30)], and cerebrospinal fluid leakage (ROR: 229.56, 95% CI (197.76, 266.47); IC: 6.61, IC025 (6.43)]. Unexpected significant nAE might also occur, such as intracranial hypotension (ROR: 428.52, 95% CI (355.18, 517.00); IC: 6.75, IC025 (6.56)], cognitive disorder (ROR: 2.65, 95% CI (2.21, 3.19); IC: 1.38, IC025 (1.11)], anterograde amnesia (ROR: 7.35, 95% CI (2.74, 19.72); IC: 1.69, IC025 (0.90)], metabolic encephalopathy (ROR: 14.77, 95% CI (10.40, 21.00); IC: 3.55, IC025 (2.93)], and myoclonus (ROR: 5.98, 95% CI (4.70, 7.59); IC: 2.46, IC025 (2.13)]. Given the wide use of baclofen, clinicians should be well-informed about important potential nAE. Although disproportional analysis is a refinement approach, it is still necessary to be vigilant about the nAE of baclofen. It is extremely crucial to early monitoring, especially in minors and the initial stage following the commencement of use.

As the first-in-class delta-like ligand 3/cluster of differentiation 3 bispecific T-cell engager approved globally for extensive-stage small cell lung cancer, tarlatamab still lacks comprehensive post-marketing safety data from real-world settings beyond clinical trials. This study employs the US Food and Drug Administration Adverse Event Reporting System (FAERS) database to conduct a comprehensive evaluation of its safety profile, identifying potential risk signals and variations among subpopulations. A retrospective analysis was conducted using data from the FAERS prior to Q2 2025. Reports listing tarlatamab as the primary suspect drug were included. Signal detection employed quadruple disproportionality analysis (reporting odds ratio (ROR), proportional reporting ratio, Bayesian confidence propagation neural network, and multi-item gamma Poisson shrinker). Adverse events (AEs) were standardized using the Medical Dictionary for Regulatory Activities v27.1. Subgroup analyses focused on sex, age, and clinical outcomes. Analysis of 676 tarlatamab-associated AE reports revealed extremely strong signals for core on-target toxicities: cytokine release syndrome (CRS) (ROR = 618.54) and immune effector cell-associated neurotoxicity syndrome (ICANS) (ROR = 1014.66). New safety signals included tumor lysis syndrome (TLS) (ROR = 48.15) and respiratory failure (ROR = 6.45), both of which exhibited significant disproportionality. Sex-based analysis identified significantly higher CRS risk in females versus males (ROR = 947.46 vs 400.82), while mortality reports were more prominent in males (ROR = 2.81). The overall onset time for all AEs exhibited an early failure pattern, with a median onset time of 3days (interquartile range, 1-10). Clinical outcomes analysis indicated death events in 12.9% of cases and hospitalization requirements in 20.9%. Leveraging FAERS, this first comprehensive real-world characterization of tarlatamab safety confirms core immune-related toxicities (CRS, ICANS) and identifies new signals (TLS, respiratory failure), with sex- and age-associated risk differences. As spontaneous-report signals are inherently hypothesis-generating, causality requires validation in robust pharmacoepidemiologic studies; meanwhile, early detection and supportive care are essential to optimize the benefit-risk profile as use expands.

The widespread use of immune checkpoint inhibitors (ICIs) has led to breakthrough advances for patients with various advanced solid tumors. As the skin is an important target organ of immune responses, it is the most commonly affected site of treatment-related adverse events associated with ICIs, with a relatively high incidence of ICI-related skin toxicity events. Immune-related adverse events induced by ICIs are increasingly becoming a bottleneck limiting their clinical application. To collect post-marketing adverse events and medication errors related to drugs and therapeutic biological products and to evaluate real-world drug safety, the United States Food and Drug Administration (FDA) established the FDA Adverse Event Reporting System (FAERS) database. Based on the FAERS database, this study aims to systematically evaluate differences in the risk of skin toxicity events among different drug subtypes, cytotoxic-T-lymphocyte-associated antigen-4 inhibitors, programmed death-1 (PD-1) inhibitors, and programmed death-ligand 1 (PD-L1) inhibitors, and to explore the limitations and potential improvements of existing pharmacovigilance methods. Skin toxicity event data from the FAERS database between 2004 and 2024 were cleaned, standardized, and screened to identify adverse events associated with the target drugs. Pharmacovigilance signal detection methods, including the reporting odds ratio (ROR) method and Bayesian confidence propagation neural network (BCPNN) method, were used for the signals of ICIs-related skin toxicity event in the data, with stratified analyses by age and sex. For the ROR method, a skin toxicity event reporting count ≥3 and a lower bound of the 95% confidence interval (CI) >1 were used as criteria for a positive signal; for the Bayesian method, the information component was used as the core parameter. Subsequently, a systematic statistical analysis of the frequencies of different types of adverse events induced by different drugs was conducted, and outcomes associated with different drugs were summarized. Pharmacovigilance signal detection methods were applied for data analysis. A total of 15 768 reports of skin-related adverse events were collected. The reported population was predominantly male, with most patients aged ≥65 years, and a higher proportion of cases from Europe and the United States. Among the reported indications, the 3 most common were malignant melanoma, non-small cell lung cancer, and metastatic melanoma. Most adverse events occurred within 30 days after drug administration, during which the number of reports was the highest. Using the two signal detection methods, positive signals were identified for 5 of the 8 target drugs: nivolumab (ROR=1.20, 95% CI 1.17 to 1.23), pembrolizumab (ROR=1.31, 95% CI 1.27 to 1.35), ipilimumab (ROR=1.82, 95% CI 1.74 to 1.90), atezolizumab (ROR=1.06, 95% CI 1.01 to 1.12), and tislelizumab (ROR=3.05, 95% CI 2.71 to 3.43). Further analysis showed that the PD-1 inhibitors pembrolizumab and nivolumab had higher numbers of reported cases of immune-mediated dermatitis, vitiligo, psoriasis, and other skin toxicity events than other ICIs. Comparison of outcomes of skin toxicity reactions caused by different drugs revealed that nivolumab-related cases had the highest numbers of reports of hospitalization, death, and life-threatening, followed by pembrolizumab. Five ICIs may induce skin toxicity events, which exhibit specific population characteristics, temporal patterns, and toxicity profiles. When using the PD-1 inhibitors nivolumab or pembrolizumab, particular vigilance is required for severe cutaneous toxicity to avoid unfavorable outcomes. Expanding the sample size and incorporating machine learning in the future may improve the precision and clinical translatability of signal detection, providing important evidence for optimizing clinical monitoring strategies for ICIs and establishing toxicity early-warning models.

Background This study aims to systematically evaluate adverse events (AEs) associated with hydrocortisone through the FDA Adverse Event Reporting System (FAERS) database. Research designs AE reports associated with hydrocortisone from Q1 2014 to Q4 2023 were extracted from the FAERS database. Multiple disproportionality analysis techniques, including Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and Empirical Bayes Geometric Mean (EBGM), were employed for signal detection. In addition, we also analyzed the time to onset of AEs. Results Analysis of 7,532 hydrocortisone-associated AEs from the FAERS database revealed significant signals across multiple system organ claasses. The strongest associations were found in endocrine disorders (ROR: 13.39), ear and labyrinth disorders (ROR: 3.05), and immune system disorders (ROR: 2.17). Additionally, the study uncovered unexpected AEs such as splenic peliosis and lymphoid tissue hypoplasia. 63.9% of the AEs occurred within 7 days of treatment. Conclusions Based on disproportionality analysis of FAERS data, this study provides new insights into the safety of hydrocortisone in the real-world setting. Future prospective studies should be conducted to validate the findings of this investigation.

Disproportionality Analysis of Nusinersen in the Food and Drug Administration Adverse Event Reporting System: A Real-World Postmarketing Pharmacovigilance Assessment

Etrasimod is a sphingosine 1-phosphate (S1P) receptor modulator that selectively activates S1P receptor subtypes 1, 4, and 5, but exhibits no detectable activity on S1P2 and S1P3. It is primarily used for the treatment of ulcerative colitis (UC). There has been limited research on the adverse events (AEs) associated with etrasimod during its use in treating UC, necessitating a comprehensive and real-world evaluation of its clinical safety. This study aims to assess the AEs of etrasimod in UC patients using data from the FDA Adverse Event Reporting System (FAERS) database. By analyzing all AEs in the FAERS database since 2004, the safety of etrasimod in clinical applications was evaluated. Based on the reporting odds ratio (ROR), proportional reporting ratio (PRR), Bayesian confidence propagation neural network (BCPNN), and multi-item gamma Poisson shrinkage (MGPS), we employed disproportionality analysis to identify all AEs associated with etrasimod in clinical application. In this study, positive signals of etrasimod-related AEs spanned multiple system organ classes (SOCs), including general disorders and administration site conditions (ROR = 1.59, 95% CI: 1.41–1.80), gastrointestinal disorders (ROR = 2.36, 95% CI: 2.06–2.71), eye disorders(ROR = 5.18, 95% CI: 4.34–6.19), metabolic and nutritional disorders(ROR = 3.49, 95% CI: 2.85–4.28), and immune system disorders(ROR = 1.56, 95% CI: 1.04–2.33). And we identified previously unreported AEs not currently listed on drug label, including headache, dizziness, fatigue, diarrhea, blurred vision, etc. Our research provides real-world evidence on the safety profile of etrasimod, which is crucial for clinicians to safeguard patient health.Supplementary InformationThe online version contains supplementary material available at 10.1038/s41598-025-19679-z.

Omadacycline is a newly launched drug of tetracycline. Therefore, it is necessary to comprehensive evaluate reports on the safety of omadacycline in large, real-world populations. This study aimed to mine the adverse event (AE) signals related to omadacycline through the Food and Drug Administration Adverse Event Reporting System (FAERS) database. Data from the FAERS database from 1 January 2004 and 31 March 2024 were queried through OpenVigil 2.1. After the completion of data mapping, we collated and summarized key demographic and clinical characteristics of the reported cases. During the analysis, both Reporting odds ratio (ROR) and Bayesian confidence propagation neural network (BCPNN) were employed for the detection of AE signals. We extracted a total of 452 suspected AE cases with omadacycline from the FAERS database. Among them, 69 positive signals were obtained using the ROR and BCPNN. The highest frequency reported systemic organ class (SOC) was gastrointestinal disorders. Common clinical AEs of omadacycline were detected in the FAERS database, such as nausea, vomiting, tongue discolouration, hepatic enzyme increased, and hypersensitivity. In addition, we identified potential unexpected serious AEs through disproportionality analysis, including eosinophilia, pancytopenia, internal haemorrhage, restless legs syndrome, hypoacusis, and tinnitus. In light of the growing use of omadacycline in clinical practice, routinely reviewing data from the FAERS database for signals of AE can help to ensure patient medication safety and enhance overall medical quality.

IntroductionTiotropium, a long-acting muscarinic antagonist, is commonly employed for the maintenance treatment of chronic obstructive pulmonary disease (COPD) and asthma. While its efficacy has been validated through numerous randomized controlled trials, safety concerns in real-world post-marketing settings necessitate further evaluation.AimThis study aimed to analyze the adverse events (AEs) associated with tiotropium reported in the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS) database to identify potential safety signals.MethodsA retrospective analysis was conducted on adverse reaction reports related to tiotropium in the FAERS database from the first quarter of 2004 to the fourth quarter of 2024. The AE names in the FAERS database were systematically classified using the Preferred Terms (PTs) and System Organ Classes (SOCs) provided by the latest version of the Medical Dictionary for Regulatory Activities (MedDRA 27.1). After deduplication, a combination of methods, including the Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and Multi-item Gamma Poisson Shrinker (MGPS), was employed for disproportionality analysis.ResultsA total of 129,763 AE reports related to tiotropium were included in the analysis, affecting 65,045 patients. These reports encompassed 27 different SOC categories, identifying 264 AEs associated with tiotropium. After excluding certain AEs deemed clinically insignificant, the most common AEs reported were dyspnea (n = 8,600), cough (n = 2,440), and pneumonia (n = 2080). The AEs exhibiting the highest signal strength included aggravated dyspnea (ROR: 162.04), hoarseness (ROR: 43.42), and aggravated chronic obstructive airway disease (ROR: 43.17). Additionally, we identified potential risks not mentioned in the instructions (United States Prescribing Information and the Canadian Product Monograph), such as epiglottic cancer, halo vision, and malignant lung tumors.ConclusionThis study offers a more comprehensive understanding of tiotropium by uncovering previously unreported adverse reactions. Physicians should take these newly identified adverse reactions into account when prescribing this medication.

Venlafaxine, a serotonin-norepinephrine reuptake inhibitor widely prescribed for major depressive disorder and related conditions, remains insufficiently characterized regarding its adverse event profile. This study aimed to comprehensively evaluate the post-marketing safety of venlafaxine using data from the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS). The data were extracted from the FAERS database from the first quarter (Q1) 2004 to Q2 2025. Adverse drug events were analyzed using the Reporting Odds Ratio (ROR), Bayesian Confidence Propagation Neural Network (BCPNN), Proportional Reporting Ratio (PRR), and Multi-Item Gamma Poisson Shrinker (MGPS) methods. A total of 47,325 venlafaxine-related adverse event reports were analyzed. Disproportionality analysis revealed significant signals for drug ineffectiveness (n = 2,108, ROR = 1.6, PRR = 1.6, χ2 = 483.4, IC = 0.7, EBGM = 1.6), drug hypersensitivity (n = 1,014; ROR = 4.9, PRR = 4.8, χ2 = 2998.7, IC = 2.2, EBGM = 4.7), and anxiety (n = 198, ROR = 4.3, PRR = 4.2, χ2 = 2202.0, IC = 2.0, EBGM = 4.1). Strongest signals (EBGM = 9.9) were observed for suicide attempt, agitated depression, and renal dysplasia. Tachycardia (EBGM = 8.3) was the most frequently reported adverse event among patients under 18years, while emotional disorder (EBGM = 9.5) predominated in those aged 65years and older. Most adverse events (39.3%) occurred within the first 30days of venlafaxine therapy initiation. This pharmacovigilance analysis systematically identified significant safety signals associated with venlafaxine. The findings provide important evidence to support safer clinical use of venlafaxine and may assist in optimizing individualized therapeutic decisions in practice.

Clascoterone is a novel drug for the treatment of acne vulgaris (AV). To gain an improved comprehension of clascoterone safety in the real world, we conducted a disproportionality analysis based on data from the U.S. Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS). Methods Data enrolled in this study was from the FAERS database, covering the period from Q3 2020 to Q4 2024. The risk signals of clascoterone were mined through four disproportional algorithms (reporting odds ratio (ROR), proportional reporting ratio (PRR), bayesian confidence propagation neural network (BCPNN), and multi-item gamma Poisson shrinker (MGPS)). The time-to-onset (TTO) analysis of risk signals was conducted. Among 1085 clascoterone-associated adverse events (AEs), five system organ classes met ROR/BCPNN positive thresholds: product issues (ROR = 16.21, 95%CI(Confidence interval) = 14.68-17.89), injury, poisoning and procedural complications (ROR = 5.69, 95%CI 5.23-6.2), surgical and medical procedures (ROR = 2.97, 95%CI 2.41-3.65), reproductive system and breast disorders (ROR = 1.88, 95%CI 1.25-2.83), and skin and subcutaneous tissue disorders (ROR = 1.83, 95%CI 1.58-2.12). At the preferred term (PT) level, 45 positive signals were detected, including some common AEs (erythema and dry skin) and some uncommon AEs with strong strength (such as hypothalamic pituitary adrenal axis suppression, skin striae, and hair growth abnormal). Furthermore, TTO analysis revealed that over 70% of AEs happened within the first month following therapy. Our study provides broader data support for the safety of clascoterone and offers important insights to enhance the clinical use and minimize potential adverse effects.

BackgroundGanirelix, a third-generation GnRH antagonist, is widely used in assisted reproductive technology (ART) for rapid pituitary suppression to prevent premature luteinizing hormone (LH) surges. Despite its extensive clinical use, real-world evidence on its safety in large populations remains scarce. This study aimed to evaluate the safety profile of ganirelix by comprehensively analyzing adverse drug events (ADEs) using real-world data from the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS) and the Japan Adverse Drug Event Reporting (JADER) database.MethodsWe extracted ADE data from FAERS (Q1 2004–Q2 2024) and JADER (Q1 2009–Q1 2024). Disproportionality analyses, including reporting odds ratios (ROR), proportional reporting ratios (PRR), Bayesian Confidence Propagation Neural Networks (BCPNN), and Multi-item Gamma Poisson Shrinkage (MGPS), were employed to identify significant associations between ganirelix and ADEs.ResultsIn the FAERS database, we identified 1,096 ganirelix-related ADE reports, spanning 26 system organ classes (SOCs). A total of 65 positive signals were detected, including ADEs consistent with drug label such as ovarian hyperstimulation syndrome (OHSS) (n = 290, ROR 2462.76, PRR 2168.48, EBGM05 1655.59, IC025 9.18), injection site pain (n = 54, ROR 3.99, PRR 3.93, EBGM05 3.13, IC025 0.31), and fetal death (n = 6, ROR 21.05, PRR 21.00, EBGM05 10.72, IC025 2.72). Additionally, unexpected signals not listed in the drug label were identified, including ectopic pregnancy (n = 7, ROR 33.02, PRR 32.93, EBGM05 17.64, IC025 3.37), maternal exposure before pregnancy (n = 30, ROR 76.09, PRR 75.16, EBGM05 74.72, IC025 6.22), dermatitis allergic (n = 4, ROR 7.98, PRR 7.97, EBGM05 3.50, IC025 1.33), and bladder tamponade (n = 4, ROR 771.47, PRR 770.3, EBGM05 311.57, IC025 7.80). The median time to ADE onset was 13 days. External validation using the JADER database (62 ganirelix-related ADE reports) confirmed four signals, including abortion (n = 19), OHSS (n = 17), missed abortion (n = 9), and fetal death (n = 8), aligning with FAERS findings.ConclusionThis study provides a robust real-world safety evaluation of ganirelix, with findings corroborated by two independent pharmacovigilance databases. While consistent with clinical observations, the identification of unexpected signals warrants further pharmacoepidemiological investigations to confirm these results.

Background: On 15 June 2020, the United States Food and Drug Administration (FDA) approved lurbinectedin for treating adult patients with metastatic small-cell lung cancer whose disease has progressed despite prior platinum-based chemotherapy. Following its market approval, safety data on lurbinectedin in large populations is currently lacking. Therefore, this study aims to evaluate adverse events (AEs) associated with lurbinectedin using the FDA's Adverse Event Reporting System (FAERS)database. Methods: Data concerning lurbinectedin from the FAERS database were extracted for the period from June 2020 to September 2023. Four disproportionality analysis algorithms were utilized to assess potential AEs linked to lurbinectedin: reporting odds ratio (ROR), proportional reporting ratio, disproportionate multi-item gamma Poisson shrinker, and Bayesian confidence propagation neural network. These algorithms were applied to quantify signals of lurbinectedin-related AEs. Result: A total of 5,801,535 AE reports were retrieved from the FAERS database, with 511 related to lurbinectedin. These lurbinectedin-induced AEs were observed in 23 system organ classes (SOCs). After simultaneously applying the four algorithms, 47 lurbinectedin-induced AE signals were detected in 23 SOCs. At the SOC level, blood and lymphatic system disorders (ROR, 6.70; 95% confidence interval [CI]: 5.47-8.22) were the only SOC that met all four algorithms. Lurbinectedin's most frequent adverse event was death (ROR: 6.11%, 95% CI: 4.86-7.68), while extravasation exhibited the strongest signal intensity in the ROR algorithm (ROR: 326.37%, 95% CI: 191.66-555.75). Notably, we identified a novel signals: tumor lysis syndrome (ROR: 63.22%, 95% CI: 33.87-117.99). The mean time of onset of AEs was 66 days, the median time of onset was 25days (interquartile range: 8-64days), and most AEs occurred within the first month of lurbinectedin treatment. Conclusion: Our study provided a comprehensive evaluation of lurbinectedin's safety profile in the post-marketing setting. In addition to the adverse events consistent with the existing clinical trials and labeling information, we have also identified an unreported signal related to tumor lysis syndrome. This finding will better guide the clinical practice of lurbinectedin and provide valuable evidence for future research.