Current drug safety最新文献

{"title":"Pharmacovigilance Analysis of Azelastine-Related Adverse Events: Insights from the FDA FAERS Database (2006-2024).","authors":"Feihong Liang, Lulu Chen, Caixi Hu, Renbin Lu, Caihui He, Guodong Yu","doi":"10.2174/0115748863416393260406204526","DOIUrl":"https://doi.org/10.2174/0115748863416393260406204526","url":null,"abstract":"<p><strong>Background: </strong>Azelastine is widely used in the treatment of allergic rhinitis, and it is necessary to gain insight into the true extent of adverse events (AEs) associated with it.</p><p><strong>Methods: </strong>This pharmacovigilance study was based on an analysis of reports from the FDA Adverse Event Reporting System (FAERS) for the period January 1, 2006, to December 31, 2024. AEs of drugs were compared using the Proportional Reporting Ratio (PRR), Reporting Odds Ratio (ROR), Bayesian Confidence Propagation Neural Network (BCPN), and Multi-item Gamma Poisson Shrinkage (MGPS).</p><p><strong>Results: </strong>The number of AE occurrences in Respiratory, thoracic, and mediastinal disorders and Product issues was high. There is a significant difference in the proportion of occurrence between men and women. All AEs listed in the drug insert were validated through this analysis. In addition to the improvement of the drug process, the focus should still be on the adverse reactions such as Dysgeusia, Nasal discomfort, and Somnolence.</p><p><strong>Conclusion: </strong>This study systematically depicts the safety profile of azelastine by analysing large-scale adverse reaction data and provides empirical evidence for the improvement of clinical dosing guidelines and risk communication strategies. Pharmacovigilance departments should maintain vigilance for rare but serious adverse reactions to azelastine to optimize its risk-benefit profile.</p>","PeriodicalId":10777,"journal":{"name":"Current drug safety","volume":" ","pages":""},"PeriodicalIF":0.7,"publicationDate":"2026-06-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148197585","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":"Assessing the Risk of Drug-Induced Influenza-Like Illness: A Disproportionality Analysis of Two Decades of FAERS Data (2004-2025).","authors":"Xing Gao, Xhuang Chen, Jie Zu, Tianya Liu","doi":"10.2174/0115748863440350260326055214","DOIUrl":"https://doi.org/10.2174/0115748863440350260326055214","url":null,"abstract":"<p><strong>Introduction: </strong>With the rising incidence of Influenza-like Illness (ILI), comprehensive studies on causative drugs remain lacking. This study aimed to detect drugs associated with ILI through disproportionality analysis of the FDA Adverse Event Reporting System (FAERS) database.</p><p><strong>Methods: </strong>Adverse Event (AE) reports were extracted from the FAERS database for the period spanning 2004 Q1 through 2025 Q1. The Medical Dictionary for Regulatory Activities (MedDRA) was used to identify ILI cases. Four statistical methods were employed to identify drugs with positive signals: the Reporting Odds Ratio (ROR), the Proportional Reporting Ratio (PRR), the Bayesian Confidence Propagation Neural Network (BCPNN), and the Empirical Bayes Geometric Mean (EBGM).</p><p><strong>Results: </strong>Our analysis identified 77,060 ILI-associated reports. A total of 60 drugs exhibited positive signals. The 5 most frequently reported drugs were interferon β-1a, evolocumab, ofatumumab, interferon β-1b, and zoledronic acid. Under the ATC1 classification, antineoplastic and immunomodulating agents accounted for the majority of reported cases (n=43,436), followed by nervous system agents (n=8,941), cardiovascular system agents (n=6,871), and musculoskeletal system agents (n=5,577). Weibull shape parameter analyses revealed β<1 for most drugs, indicating that drug-induced ILI predominantly manifested early failure types.</p><p><strong>Discussion: </strong>This study confirms known ILI risks (e.g., interferons) and reveals new signals for immunotherapies and lipid-lowering agents, providing evidence for prescribing updates. Timeto- onset analysis shows declining risk over time, highlighting the need for early symptom monitoring.</p><p><strong>Conclusion: </strong>This first comprehensive FAERS study identifies key drugs associated with ILI, including interferon β-1a, evolocumab, ofatumumab, interferon β-1b, and zoledronic acid. Clinical monitoring for drug-induced ILI is essential to enhance medication safety.</p>","PeriodicalId":10777,"journal":{"name":"Current drug safety","volume":" ","pages":""},"PeriodicalIF":0.7,"publicationDate":"2026-05-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148143001","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 Possible Protective Effect of Cerium Oxide Nanoparticles on Colistin-Induced Injury in Renal Cortex of Adult Male Albino Rats: Light and Electron Microscopic Study.","authors":"Azza I Helal, Aml Younis Marei, Maha Mohamed Abo Gazia, Sherif Abdelbaky, Marwa M Abd-Elsalam","doi":"10.2174/0115748863457976260326200744","DOIUrl":"https://doi.org/10.2174/0115748863457976260326200744","url":null,"abstract":"<p><strong>Introduction: </strong>Acute Kidney Injury (AKI) is a rapid decline in renal function. Colistin, a last resort antibiotic for multidrug-resistant infections, is associated with significant nephrotoxicity. Cerium oxide nanoparticles (CeONPs) are potent scavengers of reactive oxygen species (ROS), exhibiting antioxidant and anti-inflammatory properties. This study aimed to investigate the protective effects of CeONPs against colistin-induced renal damage in adult male albino rats.</p><p><strong>Methods: </strong>Forty-eight adult male albino rats were equally divided into four groups: Group I (Control), Group II (CeONPs), Group III (Colistin), and Group IV (CeONPs + Colistin). At the end of the experiment, blood samples were collected to assess renal function by measuring serum urea and creatinine. Kidney tissue was processed for histological examination and immunohistochemical staining to evaluate the expression of the inflammatory marker for nuclear factor Kappa B (NF-κB).</p><p><strong>Results: </strong>Colistin administration in Group III resulted in significant renal impairment, characterized by elevated serum urea and creatinine, severe histopathological damage (including tubular necrosis), and a marked increase in NF-κB expression. In contrast, rats pre-treated with CeONPs (Group IV) demonstrated significantly improved kidney function tests, a substantial reduction in histopathological lesions, and a notable decrease in NF-κB expression compared to the colistin group.</p><p><strong>Discussion: </strong>Colistin induces AKI through increased membrane permeability, oxidative damage, and acute tubular necrosis. This oxidative stress upregulates inflammatory mediators like NF- κB, exacerbating tissue injury. The renoprotective effect of CeONPs is attributed to their unique ability to switch between Ce³⁷ and Ce³⁷ oxidation states, allowing continuous ROS scavenging. By reducing oxidative stress, CeONPs also suppress the NF-κB-mediated inflammatory pathway.</p><p><strong>Conclusion: </strong>CeONPs exhibit notable nephroprotective effects against colistin-induced AKI through their antioxidant and anti-inflammatory characteristics. These findings propose CeONPs as a potential therapeutic adjunct to reduce nephrotoxicity in patients requiring colistin treatment.</p>","PeriodicalId":10777,"journal":{"name":"Current drug safety","volume":" ","pages":""},"PeriodicalIF":0.7,"publicationDate":"2026-05-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148143006","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":"Pharmacovigilance Assessment of Thrombotic Adverse Events Linked to GLP-1 Receptor Agonists: Analysis of FAERS Reports from 2020-2025.","authors":"Eman M Mansory, Osman O Radhwi","doi":"10.2174/0115748863468899260323094036","DOIUrl":"https://doi.org/10.2174/0115748863468899260323094036","url":null,"abstract":"<p><strong>Introduction: </strong>Glucagon-like peptide-1 receptor agonists are widely prescribed for diabetes and obesity. The association between GLP-1 RAs and thrombotic events remains unclear, with conflicting evidence from clinical and experimental studies. This study aims to assess the reporting of thrombotic adverse events with GLP-1 RAs in the FDA Adverse Event Reporting System (FAERS).</p><p><strong>Methods: </strong>A retrospective pharmacovigilance analysis of FAERS reports was performed. Thrombotic adverse events were identified using Standardized MedDRA Queries. Disproportionality was assessed via Reporting Odds Ratios. Time-to-onset was analyzed, and comparative analyses were conducted with Orlistat and SGLT2i.</p><p><strong>Results: </strong>1,618 unique thrombotic AE reports involving GLP-1 RAs were identified. Arterial events predominated (55.3%), followed by venous (23.2%) and mixed events (21.5%). Compared with all other drugs, GLP-1 RAs were not disproportionately associated with thrombotic AEs (overall ROR = 0.67, 95% CI: 0.64-0.71). Venous events showed the lowest disproportionality (ROR = 0.53, 95% CI: 0.48-0.59). Liraglutide displayed higher RORs than other GLP-1 RAs, while tirzepatide showed the lowest. Compared with Orlistat, GLP-1 RAs had markedly lower odds of venous events (OR 0.27), and, versus SGLT2i, lower odds across all event types.</p><p><strong>Discussion: </strong>In this large FAERS analysis, GLP-1 RAs did not show a disproportionate reporting signal for thrombotic events and, in several comparisons, appeared to have lower thrombotic reporting than alternative agents. While limitations of spontaneous reporting preclude causal inference, these findings provide reassuring real-world safety data.</p><p><strong>Conclusion: </strong>GLP-1 RAs were not associated with thrombotic AEs in FAERS and may confer a protective profile. Continued post-marketing surveillance is warranted.</p>","PeriodicalId":10777,"journal":{"name":"Current drug safety","volume":" ","pages":""},"PeriodicalIF":0.7,"publicationDate":"2026-05-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148143043","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":"Descriptive Analysis of Adverse Drug Events of Three mTOR Inhibitors Using WHO-VigiAccess.","authors":"Prerna Bhati, Prakash Haloi, Havagiray R Chitme","doi":"10.2174/0115748863459321260316063853","DOIUrl":"https://doi.org/10.2174/0115748863459321260316063853","url":null,"abstract":"<p><strong>Introduction: </strong>The mechanistic target of rapamycin (mTOR) pathway regulates cell growth, metabolism, and survival. Its dysregulation contributes to cancer, autoimmune disorders, neurodegeneration, and aging. While mTOR inhibitors such as Sirolimus, Everolimus, and Temsirolimus are therapeutically valuable, they are linked to significant adverse drug reactions (ADRs).</p><p><strong>Objective: </strong>To investigate adverse events (AEs) and ADRs associated with mTOR inhibitors using the World Health Organization's VigiAccess database.</p><p><strong>Methods: </strong>A retrospective descriptive analysis was conducted using ADRs reports from WHOVigiAccess (2000 onward). Data included patient demographics and geographic distribution. Statistical measures such as odds ratios and relative risks were applied to assess risks.</p><p><strong>Results: </strong>Sirolimus showed a 132% increased risk of gastrointestinal (GI) hemorrhage, alongside oral ulceration, highlighting mucosal toxicity. It was also linked to a 67% higher risk of interstitial lung disease and a 63% increased likelihood of ascites. Temsirolimus was associated with a 40% higher risk of pneumonia and a 36% higher risk of sepsis, reflecting immunosuppressive effects.</p><p><strong>Discussion: </strong>The findings underscore the diverse and serious ADRs of mTOR inhibitors, ranging from gastrointestinal and pulmonary complications to heightened infection risk. These outcomes emphasize the need for careful monitoring and risk-benefit evaluation in clinical use.</p><p><strong>Conclusion: </strong>mTOR inhibitors, while effective, pose substantial risks of ADRs including hemorrhage, lung disease, ascites, and infections. Clinicians should weigh therapeutic benefits against potential harms and adopt vigilant monitoring strategies to optimize patient safety.</p>","PeriodicalId":10777,"journal":{"name":"Current drug safety","volume":" ","pages":""},"PeriodicalIF":0.7,"publicationDate":"2026-05-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147971176","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":"Tenecteplase for Acute Ischemic Stroke: Improved Handling in Emergency Conditions.","authors":"Antonio Siniscalchi, Luca Gallelli, Sabrina Anticoli, Diana Amantea","doi":"10.2174/0115748863475206260508092323","DOIUrl":"https://doi.org/10.2174/0115748863475206260508092323","url":null,"abstract":"<p><p>Tenecteplase, a genetically modified recombinant tissue plasminogen activator with a long half-life, has recently been proposed as a valid alternative to alteplase for thrombolysis in patients with acute ischemic stroke. According to clinical studies and trials, tenecteplase has several practical advantages over alteplase, including administration by single bolus rather than continuous infusion, shorter treatment duration, and possibly associated with fewer complications. Not only do these features increase the efficiency of emergency department workflow, but they also enable faster reperfusion and more rapid transfer to thrombectomy-capable centers. Although clinical evidence strongly suggests that tenecteplase has greater efficacy and safety, its use may lead to implemented \"bridging therapy\" in terms of rapid administration of a full dose of intravenous fibrinolytics before endovascular thrombectomy, enhanced recanalization rates, and improved efficacy of thrombolytic treatment in ischemic stroke patients.</p>","PeriodicalId":10777,"journal":{"name":"Current drug safety","volume":" ","pages":""},"PeriodicalIF":0.7,"publicationDate":"2026-05-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147971120","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":"Liraglutide Causing Pancreatitis in an Indian Obese Female: A Case Report and Review of the Literature.","authors":"Jitendra Singh, Anju Dinkar, Rajeev Verma, Munna Lal Patel, Ajay Kumar Patwa, Nitin Bharti","doi":"10.2174/0115748863418018251111133620","DOIUrl":"https://doi.org/10.2174/0115748863418018251111133620","url":null,"abstract":"<p><strong>Introduction: </strong>Liraglutide, a glucagon-like peptide-1 receptor agonist (GLP-1 RA), is commonly prescribed for obesity and type 2 diabetes mellitus (T2DM). While its metabolic benefits are well-established, rare cases of acute pancreatitis (AP) have raised concerns about drug safety. Despite regulatory warnings from the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA), causality remains debated due to confounding factors and limited human data.</p><p><strong>Case presentation: </strong>We, herein, report the case of a 42-year-old Indian female with obesity (BMI 32.5 kg/m²) who developed acute-onset severe epigastric pain and vomiting three days prior to presentation. She had been using liraglutide 0.6 mg/day for one month for weight management. Laboratory investigations revealed significantly elevated serum amylase and lipase, while abdominal ultrasonography and contrast-enhanced CT scan confirmed acute interstitial edematous pancreatitis. No other common etiologies were identified. Prompt discontinuation of liraglutide and supportive care resulted in full clinical recovery within five days.</p><p><strong>Conclusion: </strong>A systematic literature search yielded 10 relevant case reports encompassing 11 cases of liraglutide-induced acute pancreatitis, with our case bringing the total to 12. These cases showed a slight male predominance and favorable outcomes with conservative treatment. Our report thus highlights the need for clinician vigilance and risk-benefit assessment when prescribing liraglutide, emphasizing early drug cessation upon suspicion of pancreatitis.</p>","PeriodicalId":10777,"journal":{"name":"Current drug safety","volume":" ","pages":""},"PeriodicalIF":0.7,"publicationDate":"2026-05-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147940464","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":"Comparison of the Effects of Low-Dose Versus Standard-Dose Cyproheptadine on BMI Increase in Children and Assessment of its Adverse Drug Reactions: A Randomized Clinical Trial.","authors":"Negar Javidmehr, Tina Talakesh, Hadi Raeisi, Hassan Talakesh, Saeid Heidari-Soureshjani","doi":"10.2174/0115748863470780260417103722","DOIUrl":"https://doi.org/10.2174/0115748863470780260417103722","url":null,"abstract":"<p><strong>Introduction/objective: </strong>Childhood underweight and low body mass index are major public health concerns. There is no definitive evidence on the dosage adjustment of Cyproheptadine as an appetite stimulant. This study aimed to evaluate the effect of Cyproheptadine on Body Mass Index (BMI) in underweight children and assess its associated adverse effects.</p><p><strong>Methods: </strong>This randomized double-blinded clinical trial study was conducted on thin children aged 2 to 10 years. The study was conducted on three groups of 92 children receiving low-dose Cyproheptadine, standard-dose Cyproheptadine, or placebo. Children were assessed monthly for 4 months for changes in anthropometric indices and treatment-related side effects. Data were analyzed using SPSS version 23 Results: Mean BMI showed significant between-group differences at three and four months (p = 0.001 and p < 0.001, respectively). Drowsiness occurred significantly more often in the standard- dose group than in the low-dose group at all visits (p < 0.001). No significant differences between groups in terms of irritability (p > 0.05). Mood swings were consistently more frequent in both Cyproheptadine groups than in the placebo group (p = 0.03).</p><p><strong>Discussion: </strong>These results are consistent with prior evidence supporting Cyproheptadine's role in promoting weight gain and add important insight into dose-related safety. However, the short follow-up period limits conclusions about long-term outcomes.</p><p><strong>Conclusions: </strong>Low-dose cyproheptadine is an effective and safer therapeutic option for increasing BMI in children, offering efficacy comparable to the standard dose with fewer adverse effects. These results also highlight the necessity of long-term monitoring to ensure sustained efficacy and safety.</p>","PeriodicalId":10777,"journal":{"name":"Current drug safety","volume":" ","pages":""},"PeriodicalIF":0.7,"publicationDate":"2026-04-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147834169","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 Treatment of Nociceptive Pain in DOAC-treated Patients: Could it be Safe?","authors":"Gianmarco Marcianò, Vincenzo Rania, Cristina Vocca, Caterina Palleria, Luca Gallelli","doi":"10.2174/0115748863455676260331182324","DOIUrl":"https://doi.org/10.2174/0115748863455676260331182324","url":null,"abstract":"<p><p>Direct oral anticoagulants (DOACs) are widely prescribed in patients at risk of thromboembolism. Although they are generally safer than warfarin, DOACs still carry a risk of bleeding and drug-drug interactions (DDIs). Nociceptive pain is common and may frequently occur in patients receiving DOAC therapy. In these cases, the European Society of Cardiology recommends avoiding non-steroidal anti-inflammatory drugs (NSAIDs) and preferring acetaminophen. However, acetaminophen is not effective when an inflammatory component is present. Consequently, non-pharmacological approaches or topical NSAIDs are suggested, while, in selected cases, lower-risk NSAIDs such as ibuprofen may be considered. Available evidence clearly indicates that concomitant treatment with NSAIDs and DOACs is associated with an increased risk of bleeding, although the magnitude of risk appears to differ across compounds. In this narrative review, we summarize the current evidence on bleeding risk associated with NSAID-DOAC coadministration, discuss potential DDIs from a pharmacokinetic perspective, and outline directions for future research.</p>","PeriodicalId":10777,"journal":{"name":"Current drug safety","volume":" ","pages":""},"PeriodicalIF":0.7,"publicationDate":"2026-04-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147721961","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":"Suspected Cutaneous Adverse Reaction Due to Oral Consumption of Siddha Polyherbo-Mineral Formulation, Gandhaga Rasayanam: A Case Report.","authors":"T Subathra, N Chandan, Manish Barvaliya, P Shanmugapriya, G Senthilvel","doi":"10.2174/0115748863460961260323095447","DOIUrl":"https://doi.org/10.2174/0115748863460961260323095447","url":null,"abstract":"<p><strong>Introduction: </strong>The Siddha formulation Gandhaga Rasayanam (GRM) is a classical polyherbo-mineral medicine containing purified sulphur and other herbal ingredients, including Schedule E(1) drugs. It is traditionally used to manage chronic ailments and dermatological conditions. Limited safety data have been documented for Siddha medicines; this report highlights a suspected adverse cutaneous reaction probably associated with GRM.</p><p><strong>Case summary: </strong>A 36-year-old female treated for residual Padarthamarai (Tinea cruris) developed elevated plaque with ill-defined, diffuse borders over the neck and upper back on Day 3 of therapy with GRM in combination with other Siddha medicines. This lesion was inflamed, warm to the touch, and associated with pruritus, itching, and burning. The lesions subsided markedly upon GRM withdrawal and resolved completely after a short course of levocetirizine. The patient was advised to resume other internal medicines, excluding GRM, the most suspected drug, and no recurrence was observed. This implicates GRM as the probable cause of the adverse reaction.</p><p><strong>Conclusion: </strong>This case highlights the potential for adverse reactions even with traditionally regarded safe Ayush formulations and emphasizes the need for vigilant pharmacovigilance and systematic documentation of adverse events to ensure patient safety.</p>","PeriodicalId":10777,"journal":{"name":"Current drug safety","volume":" ","pages":""},"PeriodicalIF":0.7,"publicationDate":"2026-04-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147671181","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}