Current drug safety最新文献

{"title":"Exploring Vericiguat in Heart Failure: Mechanistic Insights, Therapeutic Advantages, and Clinical Validation.","authors":"Wen-Rui Hao, Chun-Han Cheng, Huan-Yuan Chen, Ju-Chi Liu, Tzu-Hurng Cheng, Jin-Jer Chen","doi":"10.2174/0115748863377494250530105725","DOIUrl":"https://doi.org/10.2174/0115748863377494250530105725","url":null,"abstract":"<p><p>Vericiguat, a novel stimulator of soluble guanylate cyclase (sGC), marks a significant advancement in the management of heart failure with reduced ejection fraction (HFrEF). By enhancing the nitric oxide signaling pathway, it facilitates vasodilation and improves myocardial function. Clinical trials, including the VICTORIA study, have demonstrated that vericiguat effectively reduces the risk of cardiovascular death and hospitalizations associated with chronic HFrEF. The favorable safety profile of this drug, with tolerability comparable to placebo, further supports its suitability for long-term use. Understanding the pharmacodynamics and pharmacokinetics of vericiguat is essential to appreciating its clinical efficacy and its role in current heart failure treatment strategies. This review explores existing research to explore the therapeutic potential of vericiguat, its practical implications for patient care, and the need for further investigation to expand its applications. By addressing unmet needs in heart failure management, vericiguat represents a promising addition to contemporary treatment paradigms.</p>","PeriodicalId":10777,"journal":{"name":"Current drug safety","volume":" ","pages":""},"PeriodicalIF":1.1,"publicationDate":"2025-06-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144539347","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Adverse Drug Reaction Profile of Capecitabine-based Chemotherapy Regimen and its Predisposing Factors in Patients Attending a Tertiary Care Hospital in South India.","authors":"Avishek Amar, Jayanthi Mathaiyan, Biswajit Dubashi","doi":"10.2174/0115748863366875250526114841","DOIUrl":"https://doi.org/10.2174/0115748863366875250526114841","url":null,"abstract":"<p><strong>Background: </strong>Capecitabine, an important drug used for solid tumors involving the gastrointestinal tract, is known to be associated with many Adverse Drug Reactions (ADRs) leading to dose modification or discontinuation.</p><p><strong>Objective: </strong>The objective of this study was to determine the frequency and pattern of adverse drug reactions (ADRs) associated with capecitabine-based chemotherapy regimens (CBCR).</p><p><strong>Methods: </strong>A prospective observational study was carried out at a regional cancer center in South India. A total of 120 cancer patients receiving CBCR were recruited and interviewed for the occurrence of any ADRs during the complete course of chemotherapy cycles. The adverse drug events were graded for severity as per the CTCAE criteria (v4.03), and causality assessment was done using the WHO and Naranjo scales. The preventability assessment of the ADRs was conducted using the modified Schumock and Thornton scale. The chi-squared test was used to analyze the difference in the frequency of ADRs among cancer types, genders, and chemotherapy regimens.</p><p><strong>Results: </strong>The majority of ADRs (96.6%) reported throughout the treatment cycles were from the gastrointestinal system, followed by neurology-related events (93.3%). Among the various ADRs detected, skin/nail discoloration and fatigue/weakness were the most frequently reported. Causality analysis classified most ADRs under the \"possible\" category (50.5% by the WHO scale and 50.9% by the Naranjo scale). Most ADRs were of Grade I severity (54.5%) and were deemed \"probably preventable.\"</p><p><strong>Conclusion: </strong>CBCR was associated with several ADRs, though most were of Grade I severity and primarily affected the gastrointestinal system. The majority of ADRs were classified as \"possible\" based on causality analysis, and most were deemed \"probably preventable.\" Future research could focus on ameliorating these ADRs to avoid dose adjustments or discontinuation of chemotherapy.</p>","PeriodicalId":10777,"journal":{"name":"Current drug safety","volume":" ","pages":""},"PeriodicalIF":1.1,"publicationDate":"2025-06-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144282789","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The Impact of Non-Steroidal Anti-Inflammatory Drugs on Gastrointestinal Bleeding: Review on Risk Scoring for Better Prediction.","authors":"Dwi Aris Agung Nugrahaningsih, - Mustofa, Woro Rukmi Pratiwi, Dyah Samti Mayasari, Shaula Chintyasari","doi":"10.2174/0115748863356598250523095124","DOIUrl":"https://doi.org/10.2174/0115748863356598250523095124","url":null,"abstract":"<p><p>Non-steroidal anti-inflammatory drugs (NSAIDs) are commonly prescribed for pain relief and inflammation management; however, they can lead to serious upper gastrointestinal (GI) issues, including ulcers, bleeding, and perforations. This review explores various risk factors for NSAID-related GI complications, including medication dosage, duration of treatment, patient age, health history, and interactions with other drugs. It also evaluates existing measures to reduce these risks, such as using proton pump inhibitors (PPIs) and selective COX-2 inhibitors, while discussing their limitations. Emphasis is placed on the value of prediction tools that integrate multiple risk factors to enhance preventive care. The review provides an in-depth analysis of current scoring systems and examines future directions, including the integration of biomarkers, genetic data, and technologies like machine learning to improve prediction and clinical utility. By addressing gaps in existing models, it offers insights into advancing personalized approaches to minimize NSAID-induced GI complications.</p>","PeriodicalId":10777,"journal":{"name":"Current drug safety","volume":" ","pages":""},"PeriodicalIF":1.1,"publicationDate":"2025-06-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144282790","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"DRESS Syndrome with Cold Agglutinins: An Unusual Immune Response to Anticonvulsants.","authors":"Sumit Jaiswal, Sourabh Pathania, Gaurav Sharma, Ankur Singh, Upinder Kaur, Anup Singh, Sankha Shubhra Chakrabarti","doi":"10.2174/0115748863384587250519045051","DOIUrl":"https://doi.org/10.2174/0115748863384587250519045051","url":null,"abstract":"<p><strong>Introduction: </strong>DRESS (Drug Reaction with Eosinophilia and Systemic Symptoms) is a rare adverse drug reaction characterized by cutaneous and systemic manifestations, with a mortality rate of up to 10%. In this study, we describe the case of a 77-year-old man who developed DRESS syndrome with cold agglutination.</p><p><strong>Case presentation: </strong>A 77-year-old man prescribed phenytoin and carbamazepine for suspected cranial neuralgia after a tooth extraction developed high-grade fever and hemorrhagic crusting on the upper and lower lips and oral mucosa, morbilliform rashes over the chest, abdomen, and back along with facial edema, all occurring over 2 weeks. Clinically significant right-sided submandibular, cervical, and axillary lymphadenopathy was observed. Additional findings, including peripheral blood eosinophilia, hepatitis, and coagulopathy, helped us make a provisional diagnosis of DRESS syndrome. The peripheral blood smear showed an incidental finding of cold agglutination phenomenon at room temperature (16 °C; winter months in North India), which disappeared under warmer conditions. However, gross hemolysis was not confirmed. The patient showed significant response in both clinical and hematological parameters within 24 hours of initiating intravenous dexamethasone, which was continued and gradually tapered over 14 days. Follow-up at one month showed the disappearance of the cold agglutination phenomenon.</p><p><strong>Conclusion: </strong>Cold agglutination in DRESS syndrome has not been documented in detail in the past. One hypothesis is the agglutination of red blood cells (RBCs) due to the effect of the pathogenetic antibodies in DRESS syndrome directed against RBC antigens. Further molecular research may elucidate the pathways of this rare clinical finding.</p>","PeriodicalId":10777,"journal":{"name":"Current drug safety","volume":" ","pages":""},"PeriodicalIF":1.1,"publicationDate":"2025-06-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144215182","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Evaluating the Impact of SGLT-2 Inhibitors on Frailty in Older Adults: A Clinical Review.","authors":"Sulthan Al Rashid, Abinaya Vannapatti Gopalakrishnan, Naina Mohamed Pakkir Maideen, Riyadh S Almalki","doi":"10.2174/0115748863365749250519051710","DOIUrl":"https://doi.org/10.2174/0115748863365749250519051710","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Sodium-glucose cotransporter-2 (SGLT-2) inhibitors, including empagliflozin, canagliflozin, and dapagliflozin, have demonstrated significant cardiovascular and renal benefits in managing type 2 diabetes mellitus (T2DM). However, their impact on frailty in older adults remains a subject of debate, given their associations with weight loss, fluid depletion, and potential reductions in muscle mass, which could contribute to sarcopenia and frailty-related complications.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objectives: &lt;/strong&gt;This narrative review evaluates the effects of SGLT-2 inhibitors on frailty in older adults with T2DM by analyzing their influence on body composition, muscle mass, and overall functional status. It further examines the balance between their benefits and risks in frail populations, emphasizing the need for appropriate patient selection and monitoring strategies.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;A comprehensive review of systematic reviews, meta-analyses, randomized controlled trials (RCTs), and real-world observational studies was conducted. Data were obtained from major medical databases, including PubMed, Embase, Cochrane Library, and Web of Science. Studies focusing on body composition changes, cardiovascular outcomes, frailty-related events, and mortality in older adults using SGLT-2 inhibitors were analyzed.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;Findings indicate that SGLT-2 inhibitors significantly reduce body weight, visceral fat, and cardiovascular events while preserving renal function. However, multiple studies report reductions in lean body mass and skeletal muscle index, raising concerns about sarcopenia, particularly in frail individuals. Meta-analyses of RCTs reveal that SGLT-2 inhibitors may decrease skeletal muscle mass while promoting lipolysis and gluconeogenesis, potentially exacerbating frailty in high-risk populations. Despite these concerns, retrospective cohort studies and real-world evidence suggest that SGLT-2 inhibitors are associated with lower mortality and reduced frailty-related events in individuals with T2DM and heart failure. Comparative studies highlight that SGLT-2 inhibitors provide superior cardiovascular protection over dipeptidyl peptidase-4 inhibitors (DPP- 4is) and comparable benefits to glucagon-like peptide-1 receptor agonists (GLP-1RAs), albeit with an increased risk of DKA and genital infections.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusion: &lt;/strong&gt;While SGLT-2 inhibitors offer significant cardiometabolic and renal benefits, their effects on muscle mass and frailty warrant further investigation. Individualized treatment approaches- including nutritional support, exercise interventions, and close monitoring-are essential to mitigate potential risks in frail older adults. Updated clinical guidelines should address the appropriate use of SGLT-2 inhibitors in frail populations, considering both their benefits and risks. Future research should focus on elucidating the biological mechanisms underlying the","PeriodicalId":10777,"journal":{"name":"Current drug safety","volume":" ","pages":""},"PeriodicalIF":1.1,"publicationDate":"2025-05-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144198369","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Biosimilar Regulations: Current Framework and Future Prospects.","authors":"Simran Kaur, Simran Yadav, Vishesh Sahu, Navneet Sharma, Vikesh Kumar Shukla","doi":"10.2174/0115748863360017250509063745","DOIUrl":"https://doi.org/10.2174/0115748863360017250509063745","url":null,"abstract":"<p><strong>Introduction/objective: </strong>Biosimilars, a class of biologic medications that are highly similar to reference biologics, have emerged as cost-effective alternatives to their expensive originator counterparts. Due to their complex nature and manufacturing processes, biosimilars differ significantly from small molecule generics and must undergo a rigorous assessment to ensure safety, efficacy, and accessibility. This review explores the regulatory landscape surrounding biosimilars across key markets such as the United States, Europe, and India, with a focus on approval processes and post-marketing pharmacovigilance for patient safety.</p><p><strong>Methods: </strong>The study conducted a detailed review of regulatory guidelines, approval frameworks, and post-marketing requirements for biosimilars across various countries. Data was collected from official sources such as the European Medicines Agency (EMA), the United States Food and Drug Administration (FDA), and relevant Indian regulatory bodies. The research also analysed guidelines focusing on pharmacovigilance practices, particularly for vulnerable populations like paediatric and geriatric patients.</p><p><strong>Results: </strong>The analysis found that while regulatory agencies such as the EMA and FDA have established stringent biosimilar approval pathways, India's regulatory framework, though promising, still lacks comprehensive pharmacovigilance guidelines. The harmonization of global biosimilar guidelines has contributed to their widespread adoption in new therapeutic areas and emerging markets, driving market expansion. The study highlights the importance of postmarketing monitoring to ensure continued safety, with particular emphasis on vulnerable populations.</p><p><strong>Conclusion: </strong>The regulatory landscape for biosimilars is evolving, with increasing global collaboration fostering the harmonization of guidelines. Regulatory agencies such as the European Medicines Agency (EMA) and the United States Food and Drug Administration (FDA) have established rigorous approval frameworks, ensuring biosimilars meet the necessary standards for safety and efficacy. In emerging markets like India, the biosimilar sector is poised for significant growth, though the regulatory framework is still maturing. Strengthening regulatory infrastructure, particularly in areas such as approval processes and quality control, will be crucial in supporting this expansion. The review emphasizes the importance of robust and clear regulations to facilitate the safe and effective integration of biosimilars into global healthcare systems, ensuring greater accessibility for patients without compromising on quality.</p>","PeriodicalId":10777,"journal":{"name":"Current drug safety","volume":" ","pages":""},"PeriodicalIF":1.1,"publicationDate":"2025-05-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144141712","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Dermocosmetic Bioactive: Safety Assessment and Regulatory Challenges.","authors":"Afifa Akram, Radhakrishan Gaur, Indu SIngh, Shikha Baghel Chauhan","doi":"10.2174/0115748863360706250508050957","DOIUrl":"https://doi.org/10.2174/0115748863360706250508050957","url":null,"abstract":"<p><strong>Objective: </strong>This review investigates the regulatory framework for dermocosmetic bioactive in functional skincare, focusing on products with both cosmetic and pharmaceutical characteristics. The global regulatory environment, with comparisons between the EU, the US, and India, will be analyzed, emphasizing the duality in regulation. Safety assessments, bioavailability, and toxicity concerns will be key focus areas, especially considering the impact of emerging technologies such as nanotechnology and AI-driven formulation development.</p><p><strong>Method: </strong>A comprehensive literature search was performed using PubMed and Google Scholar electronic databases. This involves a comparative analysis of regulatory frameworks governing dermocosmetic bioactives across the EU, US, and India, focusing on understanding differences and similarities in their approaches. Additionally, the review will cover safety assessment techniques, including in vitro methods, ex vivo skin permeation models, and bioavailability studies to evaluate product safety and efficacy. The exploration extends to emerging technologies such as nanotechnology and the use of machine learning for predictive toxicology. It also addresses virtual clinical trials and the integration of \"-omics\" data into safety evaluations, offering new insights into regulatory compliance and risk assessment.</p><p><strong>Result: </strong>The review highlights the need for adaptive regulations to balance innovation with consumer safety. Regulatory differences in the EU, US, and India reflect varying approaches to dual- function products.</p><p><strong>Conclusion: </strong>Advances in nanotechnology, AI, and machine learning offer new pathways for formulation development and safety assessments, suggesting a future where regulatory frameworks evolve to accommodate these innovations while ensuring product safety and efficacy.</p>","PeriodicalId":10777,"journal":{"name":"Current drug safety","volume":" ","pages":""},"PeriodicalIF":1.1,"publicationDate":"2025-05-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144141740","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A Review on Process Analytical Technology as a Driver of Pharmaceutical Manufacturing for the Improvement of Quality while Reducing Costs.","authors":"Ritwik Adak, Arinya Jana, Biplab Debnath, Arijit Das, Reechik Bandyopadhyay","doi":"10.2174/0115748863374678250501184523","DOIUrl":"https://doi.org/10.2174/0115748863374678250501184523","url":null,"abstract":"<p><p>Process analytical technology has emerged as a possible game-changing platform in the pharmaceutical business to improve process knowledge while also improving product quality and lowering production costs. This paper outlines the underlying principles of PAT, its application in pharmaceutical manufacturing processes, and the impact on assurance of quality and reduction of cost. Real-time monitoring, multivariate data analysis, and process control strategies are three modules that are computed and integrated with PAT to develop robust and efficient manufacturing processes. A number of case studies and examples have been used to illustrate this relationship between the implementation of PAT and a reduction in variability with an improvement in process control and consistency of the product, which finally realizes million-dollar savings. It also debates the regulatory perspectives and challenges involved in PAT adoption, focusing on how stakeholders in the industry and agencies can integrate in developing and implementing innovations that will pass the test of compliance criteria. In general, what this paper presents is that PAT will drive pharmaceutical manufacturing into advancement for higher standards of quality with increased efficiency.</p>","PeriodicalId":10777,"journal":{"name":"Current drug safety","volume":" ","pages":""},"PeriodicalIF":1.1,"publicationDate":"2025-05-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144101483","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Identification and Detection of Pharmaceutical Impurities for Ensuring Safety Standard of Medicine: Hyphenated Analytical Techniques and Toxicity Measurements.","authors":"S K Azizuddin, Asif Husain, Mohammad Rashid, Sana Hashmi, Deepak Kumar","doi":"10.2174/0115748863361289250324042233","DOIUrl":"https://doi.org/10.2174/0115748863361289250324042233","url":null,"abstract":"<p><p>Impurity separation and detection are essential processes in the pharmaceutical industry to preserve the quality of drugs as the impurities have the potential to significantly impair the therapeutic efficacy of an active ingredient and have negative effects on pharmaceutical formulations. The primary determinant of drug development is the creation of products that adhere to the highest standards of quality and safety, with a particular emphasis on effectively managing impurities in the therapeutic ingredients. To ensure that the resulting pharmaceutical possesses a high level of safety, meticulous identification, precise quantification, and stringent management of any extraneous components present in the drug ingredient need to be performed. The literature was compiled from different databases, such as DOAJ, PubMed, Research Gate, Google Scholar, Scopus, and Science Direct. Several organic and inorganic contaminants that are frequently present in final products and active pharmaceutical ingredients (APIs) were covered, along with the crucial section for quality control and fundamental details on their security, toxicity, detection limits, and quantification limitations. Pharmaceutical companies resolve the problem of the presence of impurities by adhering to strict regulatory requirements set by reputable agencies, like the ICH, USFDA, EMA, and PMDA. Also, impurity profiling is required for the regulatory submissions of new drug candidates. In some pharmacopoeias, impurity profiling and reporting are also included. To identify and measure contaminants, a variety of analytical techniques are employed, as discussed in this article. This paper covers the scientific features of contaminants present in pharmaceutical preparations, their prevention strategies, and the application of state-of-the-art analytical techniques for their detection.</p>","PeriodicalId":10777,"journal":{"name":"Current drug safety","volume":" ","pages":""},"PeriodicalIF":1.1,"publicationDate":"2025-05-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144076464","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Safety Profile of Amantadine: A Comprehensive Analysis of Real-World Adverse Events from the FDA Adverse Event Reporting System Database.","authors":"Wenpei Chen, Xianjun Chen","doi":"10.2174/0115748863338311241225174353","DOIUrl":"https://doi.org/10.2174/0115748863338311241225174353","url":null,"abstract":"<p><strong>Background: </strong>Traumatic Brain Injury (TBI) is a significant public health issue, often leading to long-term cognitive, physical, and emotional impairments. Amantadine has emerged as a treatment option due to its potential neuroprotective properties, aiming to enhance recovery. However, its safety profile in TBI patients remains under scrutiny.</p><p><strong>Objective: </strong>This study aimed to evaluate the safety of amantadine using the FDA Adverse Event Reporting System (FAERS) database, focusing on identifying novel adverse events to inform clinical decisions.</p><p><strong>Methods: </strong>We analyzed adverse event reports of amantadine from FAERS (2004-2024), identifying 2766 reports where it was the primary suspect. Signal detection was conducted using ROR, PRR, BCPNN, and MGPS methods, ranked by ROR values. A gender subgroup analysis with Bonferroni correction ensured statistical significance.</p><p><strong>Results: </strong>Among the 2766 reports, most events were related to nervous (n=2013, ROR=2.9) and psychiatric disorders (n=1631, ROR=3.46). Notable events included hallucinations (n=302, ROR=27.57), falls (n=286, ROR=5.7), and drug inefficacy (n=266, ROR=1.34). Adverse events were more common in patients aged 65+ years (48.5%) and slightly more frequent in females (49.3%). New adverse events identified included falls, drug inefficacy, tremors, and gait disturbances, mostly occurring within the first month of treatment (39.6%).</p><p><strong>Conclusion: </strong>The study revealed significant safety concerns with amantadine, especially regarding nervous and psychiatric reactions. It highlighted the need for careful monitoring in clinical use and further research to understand mechanisms, enhance therapeutic outcomes, and minimize adverse events.</p>","PeriodicalId":10777,"journal":{"name":"Current drug safety","volume":" ","pages":""},"PeriodicalIF":1.1,"publicationDate":"2025-05-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144076467","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}