Expert Opinion on Drug Safety

Article	Citations
Genetic alterations conferring resistance to hedgehog inhibitors in basal cell carcinoma	77
The risk of menopausal symptoms in premenopausal breast cancer patients and current pharmacological prevention strategies	62
Ibrutinib plus rituximab for the treatment of adult patients with Waldenström’s macroglobulinemia: a safety evaluation	61
Assessment of adverse events of the novel antiepileptic drug lamotrigine: a real-world pharmacovigilance study based on FAERS	57
Hepatic adverse events with CDK4/6 inhibitors: a systematic review combining meta-analysis and FAERS database	51
Impact of baseline glucocorticoids (GCs) on cardiotoxic events and myocardial damage related to immune checkpoint inhibitors: a retrospective clinical research	47
A cross-sectional study on substandard and falsified medicines (fake or counterfeit drugs) in UK pharmacies during the COVID-19 pandemic	45
Safety assessment of esomeprazole: real-world adverse event signal mining and analysis based on FAERS database	42
The role of artificial intelligence in pharmacovigilance for rare diseases	41
Drug-associated pancreatic cancer: insights from real-world pharmacovigilance and network pharmacology	35
Vortioxetine in major depressive disorder: from mechanisms of action to clinical studies. An updated review	34
Safety profiles of tetracycline-class drugs: a pharmacovigilance analysis of the FAERS database	34
Real-world safety profile of riluzole: a systematic analysis of data from the FAERS database and case reports	33
Cardiac disorder-related adverse events for aryl hydrocarbon receptor agonists: a safety review	31
Biological therapies in infants and children younger than 6 years of age with atopic dermatitis: suitability and practical considerations	30
Post-marketing safety of pimavanserin: a real-world pharmacovigilance study based on the FDA adverse event reporting system (FAERS)	29
Real-world safety evaluation of brivaracetam: insights from the US FDA Adverse Event Reporting System	29
The emerging role of Bruton’s tyrosine kinase inhibition in urticaria management	29
Data mining study on adverse events of tirzepatide based on FAERS database	28
Lessons learned from COVID-19, H1N1, and routine vaccine pharmacovigilance in the United States: a path to a more robust vaccine safety program	27
Seizures associated with antibiotics: a real-world disproportionality analysis of FAERS database	26
Safety assessment of brexanolone in the FAERS database: real adverse event analysis and discussion of side effects	24
Association between methotrexate-induced Stevens-Johnson syndrome/toxic epidermal necrolysis and furosemide: a real-world disproportionality analysis	24
Thromboembolic events in younger women exposed to Pfizer-BioNTech or Moderna COVID-19 vaccines	23
Comprehensive evaluation of post-approval regulatory actions during the drug lifecycle – a focus on benefits and risks	22

The long-term safety of chronic azithromycin use in adult patients with cystic fibrosis, evaluating biomarkers for renal function, hepatic function and electrical properties of the heart	21
Long-term safety of ketamine and esketamine in treatment of depression	20
Urinary tract infections and genital mycotic infections associated with SGLT‑2 inhibitors: an analysis of the FDA Adverse Event Reporting System	20
A new paradigm in adverse drug reaction reporting: consolidating the evidence for an intervention to improve reporting	20
Pharmacovigilance study and genetic target prediction analysis of FDA adverse event reports (FAERS) for drug-induced sinusitis	19
An updated safety review of hidradenitis suppurativa treatment options	19
Monitoring and safety of CAR-T therapy in clinical practice	18
Opioid-related adverse drug events in surgical patients: risk factors and association with clinical outcomes	18
Tolerability and safety outcomes of first-line oral second-generation antipsychotics in patients with schizophrenia	18
Association between antipsychotics and pulmonary embolism: a pharmacovigilance analysis	17
Safety and effectiveness of fifth generation cephalosporins for the treatment of methicillin-resistant staphylococcus aureus bloodstream infections: a narrative review exploring past, present, and fut	17
Safety evaluation of secukinumab in pediatric patients with plaque psoriasis	17
Risk of pancreatitis and pancreatic carcinoma for anti-diabetic medications: findings from real-world safety data analysis and systematic review and meta-analysis of randomized controlled trials	16
Nail lichen planus treatment safety	16
Reply to the article ‘Investigating the root cause of N- nitrosodimethylamine formation in metformin pharmaceutical products’	15
Efficacy and safety of spesolimab for the management of generalized pustular psoriasis: a drug safety evaluation	15
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	14
Cardiac arrhythmias associated with anaplastic lymphoma kinase (ALK) inhibitors: an analysis of the FDA Adverse Event Reporting System (FAERS)	14
An update on the safety of ixazomib for the treatment of multiple myeloma	14
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	14
An update on the cognitive safety of antimuscarinics in the treatment of overactive bladder	14
Safety of non-hormonal medications for managing hot flashes	14
Safety assessment of sildenafil use in neonates: a real-world data analysis based on the FDA adverse event reporting system (FAERS)	13
Effects of adding adjuvants to propofol on the post-anesthesia cognitive function in patients undergoing gastroscopy/colonoscopy: a systematic review and meta-analysis	13
Effect of omega-3 fatty acids on cardiovascular events in high-risk patients with hypertriglyceridemia in Japan: a 3-year post-marketing surveillance study (OCEAN3 survey)	13
Ocular adverse events of cenegermin used in neurotrophic keratopathy: an analysis of the FDA adverse event reporting system database	13
Vaccine pharmacovigilance in South Africa: successes and limitations of current approaches	13
Identifying factors influencing clinicians’ reporting of medication errors: a systematic review and qualitative evidence synthesis using the theoretical domains framework	13
Post-Marketing Safety Concerns with Upadacitinib: A Disproportionality Analysis of the FDA Adverse Event Reporting system	12
Disproportionality analysis of adverse neurological and psychiatric reactions with the ChAdOx1 (Oxford-AstraZeneca) and BNT162b2 (Pfizer-BioNTech) COVID-19 vaccines in the United Kingdom	12
The safety of phthalate-containing medications used during pregnancy	12
Safety considerations with the current treatments for peripheral T-cell lymphoma	12
TBC and COVID: an interplay between two infections	12
Safety of current systemic therapies for nail psoriasis	12
Ubrogepant and rimegepant: systematic review, meta-analysis, and meta-regression of clinical studies	12
An update on the safety of biologic therapies for the treatment of polyarticular juvenile idiopathic arthritis	11
Clinical profile of acute pancreatitis following treatment with protease inhibitors: a real-world analysis of post-marketing surveillance data	11
A real-world pharmacovigilance study of FDA Adverse Event Reporting System (FAERS) for gemcitabine	11
Adverse event profiles of CDK4/6 inhibitors: a disproportionality analysis of the FDA Adverse Event Reporting System (FAERS) database	11
Evaluation of the safety profile of amivantamab based on real-world evidence: a call to vigilance	11
Adverse drug event profile of pharmacotherapies for alcohol use disorder: a retrospective pharmacovigilance disproportionality analysis study	11
Assessing adverse event burden in chronic lymphocytic leukemia treatment regimens: what’s best for patient quality of life?	11
Comparative safety analysis of Hedgehog inhibitor preparations: insights from the FAERS database	11
Sexual dysfunction with major depressive disorder and antidepressant treatments: impact, assessment, and management	11
A drug safety evaluation of dapagliflozin for diabetic nephropathies in patients with cardiovascular risk	11
Possible genetical predictors of efficacy and safety of budesonide-MMX in patients with mild-to-moderate ulcerative colitis, and safety comparison with methylprednisolone	11
The efficacy and safety of adjunctive intranasal esketamine treatment in major depressive disorder: a systematic review and meta-analysis	10
Identification of risk factors for gastrointestinal immune–related adverse events associated with immune check point inhibitors	10
Safety evaluation of oliceridine for the management of postoperative moderate-to-severe acute pain	10
Drug-induced dementia: a pharmacovigilance analysis of the FAERS database	10

Adverse events of nusinersen: a real-world drug safety surveillance study based on the FDA adverse event reporting system (FAERS) database	10
Adverse drug events associated with metreleptin administration: a real-world pharmacovigilance study from 2014 to 2024 using the FAERS database	10
Post-marketing safety of finerenone: a disproportionality analysis of the FDA adverse event reporting system	9
Adverse events in patients with cardiovascular disease taking proton pump inhibitors	9
Underuse of GLP-1 receptor agonists in the management of type 2 diabetes despite a favorable benefit-safety profile	9
Dermatologic adverse events associated with targeted therapies for melanoma	9
Association between cyclin-dependent kinase 4/6 inhibitors and venous thromboembolism: analysis of F.A.E.R.S. data	9
Immune checkpoint inhibitor-related myocarditis: current understanding and potential diagnostic and therapeutic strategies	9
Infectious events in patients with alopecia areata treated with JAK inhibitors: low burden and minimal impact on persistence in treatment	9
Resistance to hedgehog inhibitors in basal cell carcinoma: strategies to adopt	9
Evaluating safety in hyaluronic acid lip injections	9
Safety evaluation of ustekinumab for moderate-to-severe ulcerative colitis	9
Safety and tolerability evaluation of erenumab for the preventive treatment of migraine	9
Analysis of hemorrhagic drug-drug interactions between P-gp inhibitors and direct oral anticoagulants from the FDA Adverse Event Reporting System	9
Efficacy and safety evaluation of safinamide as an add-on treatment to levodopa for parkinson’s disease	9
A reappraisal of the role of fever in the occurrence of neurological sequelae following lithium intoxication: a systematic review	9
Tyrosine kinase inhibitors-associated interstitial lung disease used in non-small cell lung cancer: a pharmacovigilance analysis based on the FDA adverse event reporting system database	8
Comparative study on the occurrence of adverse effects in the concomitant use of azathioprine and aldehyde oxidase inhibitors	8
Reporting of tumor lysis syndrome with targeted therapy for hepatic cancer in the FDA adverse events reporting system	8
Insights into efficacy and safety of dapagliflozin treatment for the management in older adults with type 2 diabetes: a systematic review and meta-analysis	8
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	8
Cognitive dysfunction following finasteride use: a disproportionality analysis of the global pharmacovigilance database	8
Safety issues of psilocybin and LSD as potential rapid acting antidepressants and potential challenges	8
Completeness of pharmaceutical industry insulin adverse event reports from Africa and the Middle East	8
An update on the safety of olaparib for treating ovarian cancer	8
Safety profile of lasmiditan: a retrospective post-marketing pharmacovigilance study based on the real-world data of FAERS database	8
Adverse event of ruxolitinib cream: a real-world analysis based on FDA Adverse Event Reporting System from 2021 to 2024	7
Toxicity profiles associated with EGFR-TKIs combined with angiogenesis inhibitors in non-small cell lung cancer: an epidemiological surveillance analysis of the FDA adverse event reporting system	7
A safety review of current monoclonal antibodies used to treat multiple sclerosis	7
Real-world analysis of medications inducing meibomian gland dysfunction: based on the FDA adverse event reporting system database	7
Inclisiran: a small interfering RNA strategy targeting PCSK9 to treat hypercholesterolemia	7
Assessment of adverse events related to anti-interleukin-6 receptor monoclonal antibodies using the FDA adverse event reporting system: a real-world pharmacovigilance study	7
Analysis of clinical characteristics of terbinafine-induced subacute cutaneous lupus erythematosus	7
Infection and infestation-related adverse events of biologics in psoriasis: insights from the Food and Drug Administration Adverse Event Reporting System (FAERS)	7
Evaluating potential unexpected adverse events and mortality after oral analgesics administration in fracture care-a cohort study	7
Comparative evaluation of adverse drug reactions for tenofovir alafenamide and tenofovir disoproxil fumarate using the FAERS Database: a disproportionality analysis	7
Preserving residual kidney function in persons on peritoneal dialysis: the role of pharmacotherapy	7
Exploration and evaluation of adverse event signals of droxidopa based on the FAERS database	7
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	7
Risk factors analysis and construction of predictive models for acute kidney injury in overweight patients receiving vancomycin treatment	7
Comprehensive safety profile of dipeptidyl peptidase-4 inhibitors: a post-marketing study based on FAERS database using signal detection algorithms	7
Defining and enhancing collaboration between community pharmacists and primary care providers to improve medication safety	7
Factors affecting persistence with biologic treatments in patients with rheumatoid arthritis: a systematic literature review	7
A real-world pharmacovigilance analysis of the FDA adverse event reporting system events for polatuzumab vedotin	7
Managing the ADR of Stevens-Johnson syndrome/toxic epidermal necrolysis	7
Fluoroquinolones-related psychiatric adverse events: a real‑world retrospective and pharmacovigilance database analysis	7
Quantification of longitudinal patient-reported burden of adverse drug reactions attributed to the use of TNF-α inhibitors in inflammatory rheumatic diseases: an observational prospective cohort study	7
Nobel Prize for immune checkpoint inhibitors, understanding the immunological switching between immunosuppression and autoimmunity	6
Post-marketing safety concerns with abrocitinib: a real-world pharmacovigilance analysis of the FDA adverse event reporting system	6
A pharmacovigilance study assessing risk of angioedema with angiotensin receptor blockers using the US FDA Adverse Event Reporting System	6
Safety of proteasome inhibitor drugs for the treatment of multiple myeloma post-marketing: a pharmacovigilance investigation based on the FDA adverse event reporting system	6
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	6
Correction	6
Adverse event profiles of drug-induced decreased libido: an assessment of the US food and drug administration Adverse Event Reporting System	6
Efficacy and safety of biologics and small molecules for psoriasis in pediatric and geriatric populations. Part I: focus on pediatric patients	6
What should clinicians know about the renal effect and the mechanism of action of levosimendan?	6
Novel insights into post-marketing AEs associated with bempedoic acid: a comprehensive analysis utilizing the FAERS database	6
Signal of dementia with proton pump inhibitor after minimizing competition bias: an updated disproportionality analysis	6
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	6
Adverse events with pemigatinib in the real world: a pharmacovigilance study based on the FDA Adverse Event Reporting System	6
Comparative risk of infection of medications used for type 2 diabetes	6
Drug-induced hepatitis B virus reactivation: insights from FAERS database analysis	6
Comparison of four criteria for potentially inappropriate medications in older patients with newly diagnosed non-small cell lung cancer	6
Safety review of current pharmacotherapies for levodopa-treated patients with Parkinson’s disease	6
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	6
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	6
Safety evaluation of the trastuzumab biosimilar in Iranian women with HER2-positive breast cancer undergoing adjuvant chemotherapy: a post-marketing surveillance	6
The role of GLP-1 receptor agonists during COVID-19 pandemia: a hypothetical molecular mechanism	6
Ocular adverse events associated with platins: a disproportionality analysis of pharmacovigilance data and extensive systematic review of case reports	6
Model driven method for exploring individual and confounding effects in spontaneous adverse event reporting databases	6
Thromboembolism adverse event profiles of thrombopoietin receptor agonists: a real-world, pharmacovigilance study	6
Safety of medications for hereditary angioedema during pregnancy and lactation	6
A safety review of recently approved and emerging drugs for patients with relapsed or refractory multiple myeloma	6
Hospital-wide interventions for reducing or preventing in-hospital prescribing errors: a scoping review	5
Thalidomide: history, withdrawal, renaissance, and safety concerns	5
A pharmacovigilance analysis of FDA adverse event reporting system events for romosozumab	5
Safety assessment of ezetimibe: real-world adverse event analysis from the FAERS database	5
Antimicrobial resistance and the post antibiotic era: better late than never effort	5
Can COVID-19 have a clinically significant effect on drug metabolism?	5
An updated safety review of the drug treatments for idiopathic pulmonary fibrosis	5

A multicenter, open-label, phase 3 study to evaluate the safety of fremanezumab for migraine, subcutaneously self-administered with an auto-injection device at institutional sites and at home	5
Clinical features, treatment, and prognosis of SGLT2 inhibitors induced acute pancreatitis	5
Real-world safety evaluation of atorvastatin: insights from the US FDA adverse event reporting system (FAERS)	5
Ocular adverse events associated with BRAF and MEK inhibitor combination therapy: a pharmacovigilance disproportionality analysis of the FDA adverse event reporting system	5
Safety of current treatment options for NTRK fusion-positive cancers	5
Ocular adverse events associated with GLP-1 receptor agonists: a real-world study based on the FAERS database and network pharmacology	5
Gastrointestinal and cardiovascular adverse events associated with NSAIDs	5
A real-world disproportionality analysis of colchicine: data mining of the public version of FDA Adverse Event Reporting System	5
Safety and effectiveness of empagliflozin and linagliptin fixed-dose combination therapy in Japanese patients with type 2 diabetes: final results of a one-year post-marketing surveillance study	5
Safety profile of isocitrate dehydrogenase inhibitors in cancer therapy: a pharmacovigilance study of the FDA Adverse Event Reporting System	5
Assessment of adverse events associated with remdesivir use for coronavirus disease 2019 using real-world data	5
Antibiotics-associated pseudomembranous colitis: a disproportionality analysis of the US food and drug administration adverse event reporting system (FAERS) database	5
Drug–drug interaction of Nirmatrelvir/ritonavir and tacrolimus: A potential risk disproportionality analysis of nephrotoxicity from COVID-19 reports in FAERS	5
Immune checkpoint inhibitors-induced diabetes mellitus: a growing clinical presentation requiring our attention	5
Sex differences in adverse drug reactions from Adalimumab and etanercept in patients with inflammatory rheumatic diseases	5
Risk of respiratory, thoracic, and mediastinal disorders associated with endothelin receptor antagonists and prostacyclin-related drugs in pulmonary hypertension: a disproportionality analysis based o	5
Antifungal agents and the kidney: pharmacokinetics, clinical nephrotoxicity, and interactions	5
Dupilumab in real-life settings: a review of adverse events and their pathogenesis	5
Drug safety in thalassemia: lessons from the present and directions for the future	5
Safety and efficacy of anti-SARS-CoV-2 monoclonal antibodies in pregnancy	5
Improving the data quality of spontaneous ADR reports: a practical example from Malta	5
Barriers and facilitators for systematically registering adverse drug reactions in electronic health records: a qualitative study with Dutch healthcare professionals	5
Real-world pharmacovigilance study of FDA adverse event reporting system events for finerenone	5
Drug-induced nephrolithiasis: a real-world pharmacovigilance study of the FDA Adverse Event Reporting System	5
Safety implications of concomitant administration of antidepressants and opioid analgesics in surgical patients	5
Signal mining and gender differences analysis of adverse events in NMIBC treatment with gemcitabine and BCG bladder instillation based on the FAERS database	4
A real-world pharmacovigilance study of FDA adverse event reporting system events for atogepant	4
Ustekinumab as induction and maintenance therapy for ulcerative colitis – national extended follow-up and a review of the literature	4
Cardiovascular outcomes of urate-lowering therapies in patients with gout or hyperuricemia: a network meta-analysis	4
Direct oral anticoagulants toxicity in children: an overview and practical guide	4
Investigating the risk of deep vein thrombosis with JAK inhibitors: a disproportionality analysis using FDA Adverse Event Reporting System Database (FAERS)	4
The effectiveness and safety of aripiprazole, bromocriptine, and cabergoline in the treatment of hyperprolactinemia: a systematic review and network meta-analysis	4
A real-world pharmacovigilance study of severe cutaneous adverse reactions associated with antiepileptic drug combination therapy: data mining of FDA adverse event reporting system	4
Combined nephrotoxicity of Polymyxins and Vancomycin: a study on adverse event reporting for monotherapy versus combinations using the FDA adverse event reporting system (FAERS)	4
Safety of ramucirumab treatment in patients with advanced hepatocellular carcinoma and elevated alpha-fetoprotein	4
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	4
OnabotulinumtoxinA for the prophylactic treatment of headaches in adult patients with chronic migraine: a safety evaluation	4
Catatonia related to tacrolimus: a real world pharmacovigilance study of FDA adverse event reporting system (FAERS) database	4
Efficacy and safety of deucravacitinib for the management of psoriasis: a drug safety evaluation	4
How could employing the patient perspective transform pharmacovigilance?	4
Patients’ and health-care professionals’ perspectives on adverse drug reaction burden attributed to the use of biological DMARDs: a qualitative study	4
Weight gain, gender, and antipsychotics: a disproportionality analysis of the FDA Adverse Event Reporting System database (FAERS)	4
Anti-inflammatory strategies for atherosclerotic artery disease	4
Proton pump inhibitors and increased reporting odds of renal neoplasms: FAERS-based adverse event data mining and analysis	4
The safety profile of FLT3 inhibitors in the treatment of newly diagnosed or relapsed/refractory acute myeloid leukemia	4
Angiotensin receptor-neprilysin inhibitor and sodium-dependent glucose cotransporter-2 inhibitor-associated renal injury: a pharmacovigilance study	4
Comprehensive analysis of adverse events associated with T-cell engagers using the FAERS database	4
Adverse events associated with azithromycin and clarithromycin in adults aged ≥65: a disproportionality analysis of the FDA Adverse Event Reporting System (FAERS) database	4
Evaluating patient and physician knowledge of risks and safe use of rivaroxaban: a survey across four countries	4
A real-world adverse events study of rimegepant from the FAERS database	4
Methods for the detection of adverse drug reactions in hospitalized children: a systematic review	4
Assessment of the implementation of risk minimization measures for bosentan: a retrospective study	4
Hypercalcemia in children induced by denosumab: a case report and an analysis of the FDA adverse event reporting system database	4
Hospital registration of adverse drug reactions in electronic health records: importance and contribution to pharmacovigilance	4
Safety of lenalidomide for maintenance treatment of patients with multiple myeloma following autologous stem cell transplantation	4
An update on phosphate binders for the treatment of hyperphosphatemia in chronic kidney disease patients on dialysis: a review of safety profiles	4
Safety of topical interventions for the treatment of actinic keratosis	4
Newly identified adverse events of enzalutamide using the food and drug administration adverse event reporting system	4
Safety evaluation of the DTaP5-IPV-Hib-HepB vaccine: a review	4
New approaches to antipsychotic medication adherence – safety, tolerability and acceptability	4
Mining and analysis of adverse event signals of vandetanib based on the FAERS database	4
Somatostatin analog-induced pancreatic exocrine insufficiency: exploring our diagnostic strategy	4
Safety considerations with the use of platelet inhibitors for elderly patients with non-ST- elevation acute coronary syndrome	4
Safety of romiplostim and eltrombopag for children with immune thrombocytopenia: a pharmacovigilance study of the FDA adverse event reporting system database	4
A pharmacovigilance study on the safety of faricimab in real-world scenario using FDA adverse event reporting system database	4
Disproportionality analysis of data from VigiBase and other global product safety databases on toxicity of iron chelating agents	4