Expert Opinion on Drug Safety

Article	Citations
Adverse event profiles of drug-induced decreased libido: an assessment of the US food and drug administration Adverse Event Reporting System	138
Comparison of adverse events of poly adenosine diphosphate ribose polymerase inhibitors in patients with ovarian cancer using the United States Food and Drug Administration Adverse Event Reporting Sys	131
Adverse events in patients with cardiovascular disease taking proton pump inhibitors	105
Safety concerns associated with various types of statins: a disproportionality analysis of the FAERS database	58
The safety of phthalate-containing medications used during pregnancy	47
Novel insights into post-marketing AEs associated with bempedoic acid: a comprehensive analysis utilizing the FAERS database	42
Safety profile of isocitrate dehydrogenase inhibitors in cancer therapy: a pharmacovigilance study of the FDA Adverse Event Reporting System	42
Exploration and evaluation of adverse event signals of droxidopa based on the FAERS database	41
Drug-induced hepatitis B virus reactivation: insights from FAERS database analysis	38
Safety assessment of brexanolone in the FAERS database: real adverse event analysis and discussion of side effects	36
The role of artificial intelligence in pharmacovigilance for rare diseases	36
A real-world pharmacovigilance study of QT interval prolongation and Torsades de Pointes associated with CDK4/6 inhibitors in breast cancer patients: findings from the FDA adverse event reporting syst	35
Assessment of adverse events of the novel antiepileptic drug lamotrigine: a real-world pharmacovigilance study based on FAERS	29
Infectious events in patients with alopecia areata treated with JAK inhibitors: low burden and minimal impact on persistence in treatment	29
Mechanism and clinical utility of abatacept in the treatment of rheumatoid arthritis	28
Assessment of adverse events related to anti-interleukin-6 receptor monoclonal antibodies using the FDA adverse event reporting system: a real-world pharmacovigilance study	28
Exploration of cardiac adverse events associated with relugolix and degarelix: a multi-center pharmacovigilance study based on the FAERS database	27
Why is pharmacovigilance essential for biosimilars?	27
An update on the cognitive safety of antimuscarinics in the treatment of overactive bladder	27
An updated safety review of Hidradenitis Suppurativa treatment options	24
Underuse of GLP-1 receptor agonists in the management of type 2 diabetes despite a favorable benefit-safety profile	24
Hypogammaglobulinemia and infections in patients with multiple sclerosis treated with anti-CD20 monoclonal antibodies: a systematic review and meta-analysis of observational studies	24
Newly identified adverse events of enzalutamide using the food and drug administration adverse event reporting system	23
Safety concerns associated with BACE1 inhibitors – past, present, and future	23
The safety profile of azithromycin in pediatrics: a pharmacovigilance disproportionality analysis	22

Unveiling the hidden ocular risks of isotretinoin: a comprehensive FAERS-Based analysis	22
The effectiveness and safety of aripiprazole, bromocriptine, and cabergoline in the treatment of hyperprolactinemia: a systematic review and network meta-analysis	21
The Impact of Medication Regimen Complexity Score on Multi-Organ Dysfunction and Clinical Outcomes in Critically Ill Patients: A Cohort Study	21
Diarrhea-predominant irritable bowel syndrome treatment options eluxadoline, rifaximin, and alosetron: analysis of the FDA adverse event reporting system (FAERS) database	20
Risk of acute kidney injury in patients receiving vancomycin and concomitant piperacillin-tazobactam or carbapenem: a multicenter, retrospective cohort study	20
Safety and efficacy of anticoagulant administration in people with atrial fibrillation and advanced chronic kidney disease	20
A safety review of approved oral agents for treating type 2 diabetes and associated diseases in pregnant patients	20
Safety and efficacy of anti-SARS-CoV-2 monoclonal antibodies in pregnancy	20
Comparative disproportionality analysis of adverse events associated with combined therapy versus monotherapy of abiraterone and olaparib for prostate cancer: a pharmacovigilance study using the FAERS	19
Disease-specific ADRs of TNF-α inhibitors as reported by patients with inflammatory rheumatic diseases: a registry-based prospective multicenter cohort study	19
Post-marketing safety concerns with palbociclib: a disproportionality analysis of the FDA adverse event reporting system	18
Gastrointestinal adverse events associated with immune checkpoint inhibitors: a pharmacovigilance analysis of the EudraVigilance and VigiAccess databases	18
Update of safety profile of levonorgestrel: a disproportionality analysis based on FAERS from 2004 to 2023	18
Sodium-glucose cotransporter-2 inhibitors and cardiovascular safety profile: a pharmacovigilance analysis of the US food and drug administration adverse event reporting system	18
Long-term safety and effectiveness of vonoprazan for prevention of gastric and duodenal ulcer recurrence in patients on nonsteroidal anti-inflammatory drugs in Japan: a 12-month post-marketing surveil	18
Does the use of generative AI chatbots by patients introduce risk of adverse drug events?	18
A real-world disproportionality analysis of baloxavir marboxil: post-marketing pharmacovigilance data	17
Corticosteroids for the treatment of Duchenne muscular dystrophy: a safety review	17
Correction	17
First-time adverse drug reactions, survival analysis, and the share of adverse drug reactions in treatment discontinuation in real-world rheumatoid arthritis patients: a comparison of first-time treat	17
Cardiorenometabolic medicine as a new subspecialty in the light of novel pharmaceuticals with dual or triple benefits	17
Angioedema risk of thrombolytics: an integrated assessment using disproportionality analysis of the USFDA adverse event reporting system, case reviews and meta-analysis	16
Tirzepatide and glucagon-like peptide-1 receptor agonists: safety always comes first!	16
Comparative analysis of CDKI-related adverse events in older patients: a real-world data from the FDA adverse event reporting system database	15
SSRI withdrawal syndrome in children and adolescents: a narrative literature review	15
Current safety concerns about the use of antiseizure medications in pregnancy	15
Long-term efficacy and safety of intra-articular corticosteroid injections in patients with knee osteoarthritis	15
Cardiovascular adverse events in patients with HER2-positive breast cancer treated with trastuzumab-drug conjugates : a Bayesian disproportional real world study for signal detection leveraging the FD	15
Drug-induced erectile dysfunction: a real-world pharmacovigilance study using the FDA adverse event reporting system database	15
Post-marketing safety evaluation of zanubrutinib: a real-world pharmacovigilance analysis based on the FAERS database	15
Long-term safety of lanthanum carbonate in the real word: a 19-year disproportionality analysis from the FDA Adverse Event Reporting System	15
Disproportionality analysis of the safety profile of rufinamide in the real world: an evaluation of the FDA Adverse Event Reporting System database	15
Data mining for signal detection of adverse events for taxanes based on the food and drug administration adverse drug events reporting system database	14
Drug-induced myocarditis: a real-world pharmacovigilance study using the FDA adverse event reporting system database	14
Data pharmacovigilance analysis of medroxyprogesterone-related adverse events in the FDA adverse event reporting system	14
Vancomycin and linezolid: severe cutaneous adverse reactions to drugs	14
Biologic and targeted synthetic therapies in juvenile idiopathic arthritis: a review of current and emerging therapeutic agents	14
Assessment of adverse events of tasimelteon: a real-world pharmacovigilance study based on FAERS	13
Long-term safety profile and secondary effectiveness of canakinumab in pediatric rheumatic diseases: a single-center experience	13
Exploration of the clinical characteristics and potential mechanisms of liver injury induced by proton pump inhibitors	13
GLP-1-derived therapies and risk of sarcopenia: myth or reality?	13
Drug safety evaluation of ixekizumab for psoriasis: a review of the current knowledge	12
How do safety warnings on medicines affect prescribing?	12
Development and validation of a nomogram to predict the risk of potentially inappropriate medication use in older lung cancer outpatients with multimorbidity	12
Treatment free remission (TFR) after second-generation tyrosine kinase inhibitors (2G-TKIs) treatment in chronic myeloid leukemia (CML): from feasibility to safety	12
Safety considerations for drugs newly approved for treating acute myeloid leukemia	12
Differences in safety profiles of anti-herpesvirus medications: a real-world pharmacovigilance study based on the FAERS database	12
Anticoagulant-associated calciphylaxis: analysis of USFDA adverse event report system and clinical feature analysis of reported cases	12
Adverse events associated with acute pancreatitis caused by immune checkpoint inhibitors: a pharmacovigilance analysis of the FDA adverse event reporting system (FAERS) database	12
Adverse events associated with inclisiran: a real-world disproportionality analysis based on the FAERS database	11

Antibody-drug conjugates-related interstitial lung diseases: data mining of the FAERS database	11
Comparative effectiveness and safety of drug therapy for chronic urticaria: a network meta-analysis and risk-benefit assessment	11
Adverse event profile of ocular injury associated with JAK inhibitors in patients with rheumatoid arthritis: a disproportionality analysis	11
Adverse event signal analysis of type Ib MET tyrosine kinase inhibitors based on food and drug administration adverse event reporting system	11
Influence factors of metronidazole-related CNS disorders: an analysis of the Japan adverse drug event report and FDA adverse event reporting system	11
The effectiveness and safety of naldemedine in treating opioid-induced constipation among non-cancer adult patients: updated meta-analysis	11
Hemorrhage profile associated with immune checkpoint inhibitors: a systematic review and a real-world study based on the FAERS database	11
Congenital anomalies associated with the use of cardiovascular drugs during pregnancy: a large-scale data analysis from the FAERS database	11
Association between dual orexin receptor antagonists (DORAs) and suicidality: reports to the United States Food and Drug Administration Adverse Event Reporting System (FAERS)	11
Updated insights on levetiracetam-associated severe cutaneous adverse reactions: a real-world pharmacovigilance analysis	11
Safety of marketed biosimilar monoclonal antibody cancer treatments in the US: a disproportionality analysis using the food and drug administration adverse event reporting system (FAERS) database	11
Drug-induced hyperacusis: a disproportionality analysis of the FAERS database	10
Ocular toxicities associated with antibody drug conjugates and immunotherapy in oncology: clinical presentation, pathogenesis, and management strategies	10
Short-acting beta 2 agonists overuse in asthma: where are we now?	10
Skin cancer associated with calcineurin inhibitors treatment: analysis of FAERS database	10
Potential drugs for reducing the occurrence of immune checkpoint inhibitor-induced interstitial lung disease: an exploratory study using the JADER and FAERS databases	10
Adverse events of direct factor Xa inhibitors: a disproportionality analysis of the FAERS database	10
Will the future of pharmacovigilance be more automated?	10
Treating psychosis in people with Parkinson’s disease	10
Reply to Letter to the Editor regarding “Drug-induced noninfectious myocarditis: a disproportionality analysis of the FAERS database”	10
Are the current safety measures for the treatment of depression with esketamine sufficient?	10
Adverse events associated with aromatase inhibitors: an analysis of real-world datasets and drug-gene interaction network	10
The importance and utility of post market drug safety monitoring in cancer therapy	10
Safety evaluation of ILaris: a real-world analysis of adverse events based on the FAERS database	10
Comparing musculoskeletal and connective tissue disorder risks of teriparatide and abaloparatide in osteoporosis: an analysis based on FDA adverse event reporting system (FAERS)	10
Impact of preoperative pharmaceutical care consultation on medication errors in surgical patients: a comprehensive analysis	10
Detection of risk signals for ustekinumab in the real world using the FDA Adverse Event Reporting System (FAERS)	9
A review on side effect management of second-generation antipsychotics to treat schizophrenia: a drug safety perspective	9
What’s in a name? What shall we call xanomeline-trospium combination?	9
Completeness of pharmaceutical industry insulin adverse event reports from Africa and the Middle East	9
Investigating bleeding adverse events associated with BTK inhibitors in the food and drug administration adverse event reporting system (FAERS)	9
Generic pharmaceuticals, regulatory aspects, bioequivalence investigation, and perception	9
Utility and limitations of the FDA adverse events reporting system public dashboard for safety analyses: a case study with vesicular monoamine transporter 2 inhibitors	9
The Safety, Efficacy, and Clinical Use of Novel Once-Weekly Insulins in the Management of Diabetes	9
Biosimilars and immunogenicity: a matter of concern?	9
A real‑world pharmacovigilance study of FDA adverse event reporting system events for daratumumab	9
The role of co-morbidities in the development of an AEFI after COVID-19 vaccination in a large prospective cohort with patient-reported outcomes in the Netherlands	9
Analysis of the relationship between histamine H1 receptor antagonists and broad dementia events using the FAERS, JADER, and CVAR databases	9
An update on the safety of ixazomib for the treatment of multiple myeloma	8
COVID-19 vaccine safety studies- the need for a third group for extended monitoring	8
Seizures associated with antibiotics: a real-world disproportionality analysis of FAERS database	8
Risk factors analysis and construction of predictive models for acute kidney injury in overweight patients receiving vancomycin treatment	8
Dupilumab in real-life settings: a review of adverse events and their pathogenesis	8
Cognitive dysfunction following finasteride use: a disproportionality analysis of the global pharmacovigilance database	8
Contributory factors and patient harm including deaths associated direct acting oral anticoagulants (DOACs) medication incidents: evaluation of real world data reported to the National Reporting and L	8
Definition of treatment resistant psoriasis and related safety concerns	8
Liver toxicity in oncology trials and beyond: a simplified concept for management of hepatocellular drug-induced liver injury in patients with abnormal baseline liver tests	8
Efficacy and safety of biologics and small molecules for psoriasis in pediatric and geriatric populations. Part I: focus on pediatric patients	8
Reporting of tumor lysis syndrome with targeted therapy for hepatic cancer in the FDA adverse events reporting system	8
The efficacy and safety of Capivasertib (AZD5363) in the treatment of patients with solid tumor: a systematic review and meta-analysis of randomized clinical trials	8
A new paradigm in adverse drug reaction reporting: consolidating the evidence for an intervention to improve reporting	8
Hepatobiliary disorders and Direct-Acting Antiviral (DAA) therapies: real-world evidence and insights from the EudraVigilance database	8
Ocular adverse events of cenegermin used in neurotrophic keratopathy: an analysis of the FDA adverse event reporting system database	8
Effects of adding adjuvants to propofol on the post-anesthesia cognitive function in patients undergoing gastroscopy/colonoscopy: a systematic review and meta-analysis	8
Safety of medications for hereditary angioedema during pregnancy and lactation	8
Chronic sequelae of immune-related adverse events	8
Comparison of four criteria for potentially inappropriate medications in older patients with newly diagnosed non-small cell lung cancer	8
Safe prescribing of antihypertensive drugs in the elderly and managing the risk of adverse events	8
Study on analgesic-induced endocrine gland damage and its potential mechanisms	8
Tirzepatide data: safety first is safety always!	8
Drug-induced dementia: a pharmacovigilance analysis of the FAERS database	8
Real-world safety evaluation of brivaracetam: insights from the US FDA Adverse Event Reporting System	8
Safety profiles of tetracycline-class drugs: a pharmacovigilance analysis of the FAERS database	8
Comparative evaluation of adverse drug reactions for tenofovir alafenamide and tenofovir disoproxil fumarate using the FAERS Database: a disproportionality analysis	8
Cardiovascular toxicities of selective ret-specific tyrosine kinase inhibitors: a pharmacovigilance study based on the United States Food and Drug Administration Adverse Event Reporting System databas	8
COMfort Eye Trial (COMET) results - a non-inferiority, randomized, investigator-masked, two-parallel group, phase III clinical trial, to evaluate the efficacy and safety of a preservative free formula	7
Clozapine may consistently protect from suicidal behaviors while other antipsychotics may lack a specific protective effect: a comprehensive VigiBase study interpreted in the context of the prior lite	7
The impact of the COVID-19 pandemic on adverse events associated with ACEIs and ARBs: a real-world analysis using the FDA adverse event reporting system	7
Letter to the Editor in response to: “Drug-induced noninfectious myocarditis: a disproportionality analysis of the FAERS database”	7
Concomitant use of sodium-glucose co-transporter 2 inhibitors and metformin and the risk of osteomyelitis reporting: a disproportionality analysis based on FAERS database	7
Reviewing the evidence surrounding preservative-free tafluprost/timolol fixed-dose combination therapy in open-angle glaucoma and ocular hypertension management: a focus on efficacy, safety, and toler	7
Post-marketing safety of panitumumab: a real-world pharmacovigilance study	7
A comparative analysis of the safety profiles between inclisiran and other PCSK9 inhibitors from real-world evidence – what have we learned recently?	7
Pharmacovigilance insights into drug-induced cystitis: analysis of FDA data from 2004 to 2024	7
Cardiovascular adverse events associated with EGFR and HER2 dual TKIs: a pharmacovigilance study based on the FAERS database	7
Adverse events associated with inclisiran: a real-world pharmacovigilance study of FDA adverse event reporting system (FAERS)	7
Signal mining and gender differences analysis of adverse events in NMIBC treatment with gemcitabine and BCG bladder instillation based on the FAERS database	7
Postmarketing safety of [ 177 Lu]Lu-PSMA-617 radioligand therapy for prostate cancer: a disproportionality analysis of the FDA adverse event reporting system	7
Intraocular inflammation as a major adverse event of anti-vascular endothelial growth factor therapy for neovascular age-related macular degeneration: from clinical trials to real-world practice	7
A real-world pharmacovigilance study of blinatumomab based on the FDA adverse event reporting system	7

Pre- and post-operative safety considerations for patients undergoing percutaneous nephrolithotomy	7
Assessment of safety profile of ivabradine in real-world scenario using FDA adverse event reporting system database	7
The safety of available pharmacotherapy for stroke prevention in atrial fibrillation	7
Potential side effects of currently available pharmacotherapies in male lower urinary tract symptoms suggestive of benign prostatic hyperplasia	7
Investigating the risk of deep vein thrombosis with JAK inhibitors: a disproportionality analysis using FDA Adverse Event Reporting System Database (FAERS)	7
Drug-induced nephrolithiasis: a real-world pharmacovigilance study of the FDA Adverse Event Reporting System	7
Correction	7
Characteristics of adverse drug reactions induced by flutamide and bicalutamide: a real-world pharmacovigilance study using FAERS	7
Safeguarding drug safety in neonates: addressing the impact of in-hospital medication administration errors through prevention and standardization	7
Approved treatments for neovascular age-related macular degeneration: current safety and future directions	7
Injection site reactions resulting from the use of biological therapy in the treatment of moderate-to-severe plaque psoriasis	7
The safety and efficacy of sugammadex for reversing neuromuscular blockade in younger children and infants	7
Analyzing the patterns of adverse drug reactions due to anti-infectives from large-scale nationwide database in Thailand	7
Immune checkpoint inhibitor related myositis: an observational, retrospective, pharmacovigilance study	7
Comparative safety review of antithrombotic treatment options for patients with atrial fibrillation undergoing percutaneous coronary intervention	6
Risk factors, prevention and treatment of weight gain associated with the use of antidepressants and antipsychotics: a state-of-the-art clinical review	6
Safety of SGLT2 inhibitors for patients with type 2 diabetes: where are we now?	6
Incidence and risk of treatment-related fatal adverse events in cancer patients treated with antibody conjugated drugs: a systematic review and meta-analysis of randomized controlled trials	6
Incidence, clinical characteristics and related drugs analyzing of drug-induced movement disorders in 102914 inpatients: a retrospective real-world study	6
An umbrella review of systematic reviews on contributory factors to medication errors in health-care settings	6
Management of refractory checkpoint inhibitor-induced colitis	6
Examining the safety of belimumab, especially in children: an analysis of real-world pharmacovigilance data from the US FDA adverse event reporting system (FAERS) database	6
Safety of PARP inhibitors as maintenance therapy in ovarian cancer	6
Suspected statin-related adverse drug reactions: analysis of spontaneous reports in Hubei Province, China (2014–2022)	6
Pulmonary adverse events associated with amiodarone: a real-world pharmacovigilance study based on the FDA adverse event reporting system	6
A real-world pharmacovigilance case/non-case study of FDA adverse event reporting system events for mannitol	6
A narrative review of the comparative safety of disease-modifying anti-rheumatic drugs used for the treatment of rheumatoid arthritis	6
Post-marketing safety assessment of constipation drugs: a real-world pharmacovigilance study based on FAERS database	6
Safety assessment of tafamidis: a real-world adverse event analysis from the FAERS database	6
Hematopoietic adverse events associated with PARP inhibitors: A FAERS database study	6
PD-1/PD-L1 inhibitors-associated cardiac adverse events: a retrospective and real-world study based on the FDA Adverse Event Reporting System (FAERS)	6
Safety and efficacy of DOACs in clinically complex phenotypes of patients with atrial fibrillation: focus on frailty, multimorbidity and polypharmacy	6
Correction	6
Infectious complications associated with immune and targeted anti-cancer therapies: a retrospective study of the FDA adverse events reporting system (FAERS)	6
Neural dysfunction, inflammatory disorder, and metabolic interference feature in amantadine-related adverse drug events: a perspective from FAERS and network toxicology	6
Bridging evidence gaps in dravet syndrome: real-world safety insights from under-reported antiseizure therapies	6
A retrospective study to evaluate Hy’s Law, DrILTox ALF score, Robles-Diaz model, and a new logistic regression model for predicting acute liver failure in Chinese patients with drug-induced liver inj	6
Is the psychedelic experience an essential aspect of the therapeutic effect of serotonergic psychedelics? Conceptual, discovery, development and implementation implications for psilocybin and related	6
Comparison of safety of acetaminophen and ibuprofen in minors: based on the FAERS database	6
Risk of serious skin and subcutaneous tissue disorders for nimesulide among the pediatric population: a jeopardy identified through the analysis of global individual case safety reports	6
Post-marketing safety surveillance of Amivantamab: a real world study based on the FDA adverse event reporting system	6
Appropriateness of psychopharmacological therapies to psychiatric diagnoses in persons with autism spectrum disorder with or without intellectual disabilities: a cross-sectional analytic study	6