BMC Pharmacology & Toxicology最新文献

{"title":"Safety profile of faricimab: a multi-source pharmacovigilance analysis using FAERS and JADER.","authors":"Chuanya Liu, Shangze Li, Ziyi Wang, Zhifu Li, Zhou Fang, Yuan Zhang, Yu Gao","doi":"10.1186/s40360-025-00902-6","DOIUrl":"https://doi.org/10.1186/s40360-025-00902-6","url":null,"abstract":"<p><strong>Background: </strong>Faricimab is a bispecific antibody targeting vascular endothelial growth factor (VEGF) and angiopoietin-2 (Ang-2), offering a novel therapeutic approach for ocular diseases. However, its long-term safety profile remains under evaluation. This study analyzes its adverse events (AEs) using the U.S. FDA Adverse Event Reporting System (FAERS) and the Japanese Adverse Drug Event Report (JADER).</p><p><strong>Methods: </strong>AEs from FAERS (2004-2024) and JADER (2004-2024) were analyzed using disproportionality algorithms. Subgroup analyses assessed differences by age and sex. AE onset time was also assessed.</p><p><strong>Results: </strong>Several newly identified adverse events (AEs) were observed, including macular ischemia, keratic precipitates, and optic nerve injury, with strong safety signals detected in both FAERS and JADER. For instance, macular ischemia showed a high association with faricimab use (ROR = 260.46), suggesting a potential risk of retinal circulation impairment. Similarly, keratic precipitates (ROR = 739.65) indicate a notable inflammatory response. All these findings highlight the need for closer monitoring of ocular complications, particularly in high-risk patient groups. The FAERS database mainly reported retinal occlusive vasculitis, ocular vasculitis, and keratic precipitates, while JADER predominantly featured retinal occlusive vasculitis and retinal vascular occlusion. Sex-based differences indicated a higher risk of inflammatory AEs in females (e.g., uveitis and eye inflammation) and a greater incidence of retinal vascular events in males (e.g., retinal vasculitis). Age-related differences showed that older patients (≥65 years) had lower inflammatory AE risks but were more prone to optic nerve damage and retinal atrophy, while younger patients (<65 years) exhibited a higher risk of vitreous hemorrhage and cataracts.</p><p><strong>Conclusions: </strong>This study identified previously unreported safety signals, suggesting the need for potential updates to faricimab's safety labeling. Faricimab's dual-target mechanism presents unique safety concerns. Clinicians should monitor ocular inflammation and vascular complications, particularly in younger males and Asian patients. Further studies using real-world data are needed to validate these findings.</p>","PeriodicalId":9023,"journal":{"name":"BMC Pharmacology & Toxicology","volume":"26 1","pages":"82"},"PeriodicalIF":2.8,"publicationDate":"2025-04-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11994024/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143969660","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Commentary on \"real world results of ibrutinib in patients with relapsed or refractory chronic lymphocytic leukemia: a meta-analysis of clinical studies\".","authors":"Ali Beheshti Namdar, Masoud Keikha","doi":"10.1186/s40360-025-00923-1","DOIUrl":"https://doi.org/10.1186/s40360-025-00923-1","url":null,"abstract":"","PeriodicalId":9023,"journal":{"name":"BMC Pharmacology & Toxicology","volume":"26 1","pages":"80"},"PeriodicalIF":2.8,"publicationDate":"2025-04-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11992757/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143953038","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Saikosaponin D inhibits the inflammatory response of secretory otitis media through FTO-mediated N⁶-methyladenosine modification of TLR4 mRNA.","authors":"Minjing Yin, Xiuli Han","doi":"10.1186/s40360-025-00910-6","DOIUrl":"https://doi.org/10.1186/s40360-025-00910-6","url":null,"abstract":"<p><p>Secretory Otitis Media (SOM) is a non-suppurative inflammatory disease of the middle ear. Saikosaponin D (SSD), a compound with significant anti-inflammatory and immunomodulatory properties, was investigated for its preventive effects and underlying mechanisms against SOM. A rat model of SOM was established through intraperitoneal ovalbumin injection. Middle ear lavage fluid (MELF) and tissue samples were collected for comprehensive analysis, including bacterial load quantification, neutrophil enumeration, and inflammatory factor assessment. HEK293T cells were utilized for mechanistic validation. Our findings demonstrated that SSD preventive treatment significantly reduced colony-forming units (CFUs) in SOM-induced rats, attenuated middle ear mucosal thickening, and suppressed pro-inflammatory cytokine levels (TNF-α, IL-6, and INF-γ). Mechanistically, SSD treatment counteracted SOM-induced m⁶A level elevation and reversed the downregulation of FTO expression. Functional studies revealed that FTO inhibition exacerbated inflammatory responses, while SSD treatment mitigated these effects. Further investigation demonstrated that SSD decreased TLR4 mRNA stability through FTO-mediated m⁶A modification. In conclusion, SSD alleviates SOM progression by reducing bacterial load and neutrophil infiltration. The therapeutic effects are mediated through FTO upregulation and subsequent m⁶A-dependent TLR4 mRNA degradation. This study elucidates a novel molecular mechanism underlying SSD's preventive action against SOM development.</p>","PeriodicalId":9023,"journal":{"name":"BMC Pharmacology & Toxicology","volume":"26 1","pages":"79"},"PeriodicalIF":2.8,"publicationDate":"2025-04-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11987459/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143971847","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Comparison of the efficacy of sucroferric oxyhydroxide and lanthanum carbonate in the hyperphosphatemia of maintainable Hemodialysis.","authors":"Min Li, YiJing Kang, Chao Zhang, XiQuan Ni","doi":"10.1186/s40360-025-00914-2","DOIUrl":"https://doi.org/10.1186/s40360-025-00914-2","url":null,"abstract":"<p><strong>Objective: </strong>To study the efficacy of sucroferric oxyhydroxide (SFOH) and lanthanum carbonate (LC) in the treatment of hemodialysis hyperphosphatemia.</p><p><strong>Methods: </strong>A total of 60 hemodialysis patients with secondary hyperparathyroidism combined with hyperphosphatemia from January 2024 to April 2024 in China Rongtong Medical & Healthcare Group Tai'an 88 Hospital were selected. All patients were randomly divided into 2 groups. One group was treated with SFOH, and the other with LC. Patients in the 2 groups were treated for 3 months continuously, and clinical outcomes, serum phosphorus, serum calcium, and intact parathyroid hormone (iPTH) levels were compared before treatment, and at 1, 2, and 3 months after treatment.</p><p><strong>Results: </strong>When compared with before treatment, the serum phosphorus levels of both groups of patients decreased significantly after 1 month, 2 months, and 3 months of treatment, with statistical significance (P < 0.01). The degree of serum phosphorus decrease in SFOH group was higher than that in LC group (P < 0.01, P < 0.05). There was no statistically significant difference in the effect of serum calcium between the two groups (P > 0.05). Both groups of patients showed a significant decrease in iPTH after treatment, with a statistically significant difference (P < 0.01). The degree of iPTH decrease in SFOH group was more pronounced than in LC group (P < 0.05). After treatment, the serum hosphorus compliance rates of SFOH group and LC Group were 80% and 53.3%, respectively, and the difference in effective rates between the two groups was statistically significant (P < 0.05).</p><p><strong>Conclusion: </strong>SFOH was superior to LC in lowering patients' blood phosphorus and iPTH levels in patients with maintenance hemodialysis hyperphosphatemia combined with secondary hyperparathyroidism.</p>","PeriodicalId":9023,"journal":{"name":"BMC Pharmacology & Toxicology","volume":"26 1","pages":"78"},"PeriodicalIF":2.8,"publicationDate":"2025-04-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11984282/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143958229","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Modified diatom-based ocular suspension for sustained diclofenac sodium delivery: a novel drug carrier approach.","authors":"Ramin Ghasemi Shayan, Dorsa Jalaei, Faramarz Dobakhti","doi":"10.1186/s40360-025-00917-z","DOIUrl":"https://doi.org/10.1186/s40360-025-00917-z","url":null,"abstract":"<p><strong>Purpose: </strong>Ophthalmic drugs typically last only around 15 minutes due to rapid elimination from tear flow, with only about 2% absorption, while the rest may enter the nasal mucosa, potentially causing systemic side effects. Diatoms, with properties like unique structure, abundance, low cost, heat resistance, non-toxicity, and easy access, present a promising solution for sustained drug delivery. This study aimed to prepare and evaluate an ocular suspension of diclofenac sodium loaded onto modified diatoms.</p><p><strong>Methods: </strong>Diatoms were modified with aluminum sulfate solution, followed by loading of diclofenac sodium. Characteristics of diatoms before and after modification-particle size, surface charge, and drug loading-were analyzed using electron microscopy, FTIR (Fourier Transform Infrared Spectroscopy), XRD (X-ray Diffraction), and elemental mapping. BET (Brunauer-Emmett-Teller (Surface Area Analysis) testing provided adsorption data, while DSC (Differential Scanning Calorimetry) assessed thermal properties. An in vitro release study using a dialysis bag in artificial tear fluid examined drug release over 8 hours. Drug content was determined by spectrophotometry, and cytotoxicity on MDA-MB-231 and HEP-G2 cell lines was evaluated at different diatom concentrations.</p><p><strong>Results: </strong>SEM (Scanning Electron Microscopy) imaging showed no topographic changes post-modification. BET and XRD analyses confirmed drug loading and structural stability, while FTIR indicated involvement of carboxylate groups. TGA and DSC showed stable thermal properties. Elemental mapping confirmed increased surface elements and high drug loading. Modified diatoms showed sustained drug release and no significant cytotoxicity differences.</p><p><strong>Conclusion: </strong>Modified diatoms demonstrated higher drug loading and sustained release, indicating their potential for safe and effective ocular drug delivery. Further studies are recommended to confirm these findings.</p>","PeriodicalId":9023,"journal":{"name":"BMC Pharmacology & Toxicology","volume":"26 1","pages":"77"},"PeriodicalIF":2.8,"publicationDate":"2025-04-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11983991/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143967975","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Kaempferol inhibits cardiomyocyte pyroptosis via promoting O-GlcNAcylation of GSDME and improved acute myocardial infarction.","authors":"Jie Zhou, Huifei Zhou, Jianfeng Zhu, Shunjin Fang","doi":"10.1186/s40360-025-00908-0","DOIUrl":"10.1186/s40360-025-00908-0","url":null,"abstract":"<p><p>Acute myocardial infarction (AMI) is a leading fatal cardiovascular disease and poses a major threat to human health. Pyroptosis, an inflammation-related programmed cell death, plays a critical role in the progression of AMI. Kaempferol is a natural flavonoid compound with a variety of pharmacological effects, which exerts a significant cardioprotective function. The role of O-GlcNAcylation, a post-translation modification, has received attention in diseases including AMI. In this research, we explored the therapeutic potential of Kaempferol to AMI due to its well-known cardioprotective effect, including its antioxidant and anti-inflammatory properties. Hypoxia/reoxygenation (H/R) model was adopted to provoke myocardial injury and AMI mice model was established. Our findings indicated that H/R lessened cell viability and contributed to the release of LDH, IL-1β and IL-18, cell pyroptosis rate, and the expression of NLRP3, active caspase 1 and GSDMD-N-terminal domain (GSDMD-N). Kaempferol mitigated myocardial damage caused by H/R through repressing cell pyroptosis. Besides, we discovered that Kaempferol restored the levels of O-GlcNAcylation by regulating the activity of OGT (O-GlcNAc transferase) and OGA (O-GlcNAcase) in H/R-treated H9c2 cells. Notably, molecular docking revealed the binding relationship between Kaempferol and OGT. Further, we proved that knockdown of OGT abrogated the function of Kaempferol in H/R-induced pyroptosis. In AMI mice, Kaempferol relieved the myocardial tissue injury and decreased the NLRP3 and GSDME-N protein levels. More importantly, our results illustrated that OGT was responsible for the O-GlcNAcylation of GSDME at T94 site and acted as an inducing factor for GSDME phosphorylation. Namely, this study validated that Kaempferol facilitated GSDME O-GlcNAcylation to inhibit H/R-induced pyroptosis in an OGT-dependent manner.</p>","PeriodicalId":9023,"journal":{"name":"BMC Pharmacology & Toxicology","volume":"26 1","pages":"76"},"PeriodicalIF":2.8,"publicationDate":"2025-04-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11980313/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143810433","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Development and validation of simple colorimetric methods for assessing norfloxacin in pure form, in pharmaceutical products and in biological material.","authors":"Muhammad Naeem Khan, Muhammad Adnan, Nusrat Bibi, Asif Kamal, Abd El-Zaher M A Mustafa, Iftikhar Ali","doi":"10.1186/s40360-025-00916-0","DOIUrl":"10.1186/s40360-025-00916-0","url":null,"abstract":"<p><p>Two straightforward, affordable, accurate, and spectrophotometric techniques gross developed to assess norfloxacin, formulations, and biological samples. The oxidation of norfloxacin will be done in technique (A) in acid solution with help of Fe(III). A wavelength of 511 nm with a correlation coefficient of 0.9879 was produced by the resulting Fe(II) coupled with 1,10-phenanthroline and the red colour complex. A uniform absorbance ranging from 1 to 30 µg/mL was discovered. Similarly, in procedure (B), in an acidic medium, Ce(IV) was added to norfloxacin. After reacting with a specific amount of methyl orange, the residual Ce(IV) is then determined. An absorbance measurement at 508 nm and a correlation coefficient of 0.9966 indicate a straight-line relationship between the two variables for concentration range is 1-15 µg/mL. The procedures were developed after a careful analysis of the several elements that influence the reaction process. After calculations, the LOD (limits of detection) and LOQ (limit of quantification) were determined to be 1.098 and 1.111 µg/mL for method A and 2.875 and 3.368 µg/mL for method B respectively. The method B has also been applied for the determination of norfloxacin in spiked human plasma and urine samples. The percentage recoveries ranged from 98.74 to 103.43% and from 98.17 to 100.85% for plasma and urine samples, respectively. Proposed techniques have been successfully used for the examination of biological fluids, formulations for medicines as well as pure norfloxacin following statistical validation through recovery studies.</p>","PeriodicalId":9023,"journal":{"name":"BMC Pharmacology & Toxicology","volume":"26 1","pages":"75"},"PeriodicalIF":2.8,"publicationDate":"2025-04-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11978087/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143802316","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A retrospective research of adverse event reporting system events for voxelotor based on the FAERS database.","authors":"Ying Lin, Hua Li, Yuqing Dong, Weiyue Fang, He Huang, Muqing He, Xiaohai Zhou, Ni Sun","doi":"10.1186/s40360-025-00915-1","DOIUrl":"10.1186/s40360-025-00915-1","url":null,"abstract":"<p><strong>Background: </strong>Sickle cell disease (SCD) is a severe genetic disorder causing anemia, pain, and organ damage, affecting millions globally. Voxelotor, approved in the United States in 2019, targeted sickle cell disease pathophysiology. Despite its therapeutic benefits, concerns remain regarding its long-term safety and potential side effects, including headaches and gastrointestinal disturbances. This study used the FDA Adverse Event Reporting System (FAERS) to assess voxelotor's safety, aiming to enhance treatment strategies and clinical decision-making in SCD management.</p><p><strong>Methods: </strong>In this study, we utilized the FAERS to extract voxelotor-related adverse event reports from 2019 to 2024. We conducted descriptive and disproportionality analyses using four algorithms: Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and Multi-item Gamma Poisson Shrinkage (MGPS) to identify significant adverse event signals. The reliability of voxelotor adverse drug reactions (ADRs) was further improved by comparing with hydroxyurea ADRSs. Finally, adverse reactions were divided into acute ADRS, delayed ADRs and efficacy related reports to analyze the adverse event onset time.</p><p><strong>Results: </strong>A total of 16,677,340 case reports were collected in the FAERS database, of which 20,902 reports related to voxelotor were identified. Voxelotor induced adverse events occurred in 27 system organ categories (SOC). Key system organ classes affected were the blood and gastrointestinal systems. Notably, some adverse events, such as priapism and osteonecrosis, were not listed on the drug's label. The median adverse event onset time of acute ADRs, delayed ADRs and efficacy related reports were 1, 189.5 and 271 days, respectively.</p><p><strong>Conclusion: </strong>This study systematically analyzed ADRs of voxelotor, highlighting the need for ongoing monitoring and further research on voxelotor's long-term safety and efficacy in treating sickle cell disease.</p>","PeriodicalId":9023,"journal":{"name":"BMC Pharmacology & Toxicology","volume":"26 1","pages":"74"},"PeriodicalIF":2.8,"publicationDate":"2025-04-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11969824/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143778762","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Melasma secondary to drugs: a real-world pharmacovigilance study of the FDA adverse event reporting system (FAERS).","authors":"Yaxin Qu, Shuxin Wang, Hanzhang Xie, Xiao Meng, Bingnan Cui, Zhanshuo Xiao","doi":"10.1186/s40360-025-00912-4","DOIUrl":"10.1186/s40360-025-00912-4","url":null,"abstract":"<p><strong>Background: </strong>Melasma is a common hyperpigmentation disorder that causes significant distress to patients. In the real world, it is closely associated with various medications, making the timely identification and discontinuation of causative drugs an important aspect of clinical management. This study investigates the relationship between melasma and drug exposure based on data from the FDA Adverse Event Reporting System (FAERS) database.</p><p><strong>Methods: </strong>This study includes reports from the first quarter of 2004 to the second quarter of 2024, focusing on cases related to melasma. We employed four statistical methods to analyze the association between suspected drugs and adverse events related to melasma.</p><p><strong>Results: </strong>Within a specific timeframe, we extracted a total of 408 adverse reaction reports related to melasma. The result shows that a higher number of cases in female patients compared to male patients. The United States had the highest number of reported cases. We identified 22 drugs that were notably associated with melasma. Among these, the contraceptive \"Ethinylestradiol and norethindrone\" demonstrated the strongest signal of association.</p><p><strong>Conclusions: </strong>Melasma is associated with exposure to various medications, with a notable proportion of cases coincided with contraceptive use. The mechanisms involved include hormonal disturbances and oxidative stress.</p>","PeriodicalId":9023,"journal":{"name":"BMC Pharmacology & Toxicology","volume":"26 1","pages":"73"},"PeriodicalIF":2.8,"publicationDate":"2025-03-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11956175/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143750921","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Rotigotine safety in real-world settings: a pharmacovigilance study using FAERS data.","authors":"Jiakuan Tu, Chaoxiang Zhang, Yichun Qiu, Hao Zhang, Jiaxin Zheng, Shuihua Xie, Jianhua He","doi":"10.1186/s40360-025-00911-5","DOIUrl":"10.1186/s40360-025-00911-5","url":null,"abstract":"<p><strong>Background: </strong>This pharmacovigilance study aims to assess adverse reactions to rotigotine based on spontaneous reports in the FDA Adverse Event Reporting System (FAERS) database, providing insights for clinical dosing.</p><p><strong>Methods: </strong>We conducted a retrospective analysis using FAERS data from Q2 2007 to Q2 2024, employing four disproportionality analysis methods: Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and Multinomial Gamma Poisson Shrinkage (MGPS). These methods were utilized to detect and evaluate adverse events (AEs) associated with rotigotine.</p><p><strong>Results: </strong>The dataset retrieved from the FAERS, encompassing 17,522,075 reports, a subset of 7,570 AE reports specifically implicated rotigotine. Upon analysis, 172 preferred terms (PTs) exhibited significant disproportionality and were consistently identified by the four employed algorithms. Particularly, product adhesion issue(N = 1,336, ROR 115,28 [108.94-121.98], PRR 108.46 [135850.43], EBGM 103.57 [98.79], IC (5.03) [5.03]) emerged as the predominant AE. Serious and unexpected AEs, such as drug ineffectiveness(N = 651, ROR 1.32 [ 1.22-1.43], PRR 1.31 [50.04], EBGM 1.31 [1.23], IC 0.39 [-1.27]), fall incidents(N = 361, ROR 2.93 [2.64-3.25 ], PRR 2.9 [451.76], EBGM 2.9 [2.66], IC 1.54 [-0.13]), and Parkinson's disease(N = 345, ROR 51.57 [46.31-57.42], PRR 50.79 [16476.71], EBGM 49.7 [45.43], IC 5.64 [3.97], were also recorded.The majority of these AEs were reported within the initial 30 days of therapy (n = 298, 22.1%), whereas a significant number were noted after 360 days of treatment (n = 507, 36.2%). The median time to the onset of AEs was 213 days.</p><p><strong>Conclusion: </strong>Our findings, which align with the established safety profile of rotigotine, reveal the presence of unexpected serious AEs and emphasize the importance of continued vigilance in post-marketing surveillance.</p>","PeriodicalId":9023,"journal":{"name":"BMC Pharmacology & Toxicology","volume":"26 1","pages":"72"},"PeriodicalIF":2.8,"publicationDate":"2025-03-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11956487/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143750960","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}