Expert Opinion on Drug Safety

Article	Citations
Genetic alterations conferring resistance to hedgehog inhibitors in basal cell carcinoma	53
The risk of menopausal symptoms in premenopausal breast cancer patients and current pharmacological prevention strategies	52
Ibrutinib plus rituximab for the treatment of adult patients with Waldenström’s macroglobulinemia: a safety evaluation	52
Evaluation of the safety profile of amivantamab based on real-world evidence: a call to vigilance	44
A cross-sectional study on substandard and falsified medicines (fake or counterfeit drugs) in UK pharmacies during the COVID-19 pandemic	42
Data mining study on adverse events of tirzepatide based on FAERS database	38
Real-world safety profile of riluzole: a systematic analysis of data from the FAERS database and case reports	38
Cardiac disorder-related adverse events for aryl hydrocarbon receptor agonists: a safety review	35
Lessons learned from COVID-19, H1N1, and routine vaccine pharmacovigilance in the United States: a path to a more robust vaccine safety program	34
Efficacy and safety evaluation of safinamide as an add-on treatment to levodopa for parkinson’s disease	31
Seizures associated with antibiotics: a real-world disproportionality analysis of FAERS database	30
Association between methotrexate-induced Stevens-Johnson syndrome/toxic epidermal necrolysis and furosemide: a real-world disproportionality analysis	29
Resistance to hedgehog inhibitors in basal cell carcinoma: strategies to adopt	28
Safety assessment of brexanolone in the FAERS database: real adverse event analysis and discussion of side effects	27
Dermatologic adverse events associated with targeted therapies for melanoma	26
Defining and enhancing collaboration between community pharmacists and primary care providers to improve medication safety	26
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	25
Tolerability and safety outcomes of first-line oral second-generation antipsychotics in patients with schizophrenia	24
Monitoring and safety of CAR-T therapy in clinical practice	24
Opioid-related adverse drug events in surgical patients: risk factors and association with clinical outcomes	24
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	23
Association between antipsychotics and pulmonary embolism: a pharmacovigilance analysis	21
Safety evaluation of secukinumab in pediatric patients with plaque psoriasis	21
Effects of adding adjuvants to propofol on the post-anesthesia cognitive function in patients undergoing gastroscopy/colonoscopy: a systematic review and meta-analysis	20
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	19

Urinary tract infections and genital mycotic infections associated with SGLT‑2 inhibitors: an analysis of the FDA Adverse Event Reporting System	19
Cognitive dysfunction following finasteride use: a disproportionality analysis of the global pharmacovigilance database	19
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	18
Comparative study on the occurrence of adverse effects in the concomitant use of azathioprine and aldehyde oxidase inhibitors	18
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	16
Efficacy and safety of spesolimab for the management of generalized pustular psoriasis: a drug safety evaluation	16
Reply to the article ‘Investigating the root cause of N- nitrosodimethylamine formation in metformin pharmaceutical products’	16
Nail lichen planus treatment safety	16
Safety of current treatment options for NTRK fusion-positive cancers	16
Safety of non-hormonal medications for managing hot flashes	15
Cardiac arrhythmias associated with anaplastic lymphoma kinase (ALK) inhibitors: an analysis of the FDA Adverse Event Reporting System (FAERS)	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
A real-world pharmacovigilance study of FDA Adverse Event Reporting System (FAERS) for gemcitabine	14
An update on the safety of ixazomib for the treatment of multiple myeloma	14
Safety of medications for hereditary angioedema during pregnancy and lactation	14
An update on the cognitive safety of antimuscarinics in the treatment of overactive bladder	14
Thalidomide: history, withdrawal, renaissance, and safety concerns	13
Vaccine pharmacovigilance in South Africa: successes and limitations of current approaches	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
Identifying factors influencing clinicians’ reporting of medication errors: a systematic review and qualitative evidence synthesis using the theoretical domains framework	13
Ocular adverse events of cenegermin used in neurotrophic keratopathy: an analysis of the FDA adverse event reporting system database	13
Safety assessment of sildenafil use in neonates: a real-world data analysis based on the FDA adverse event reporting system (FAERS)	13
Safety of current systemic therapies for nail psoriasis	12
Safety considerations with the current treatments for peripheral T-cell lymphoma	12
Post-Marketing Safety Concerns with Upadacitinib: A Disproportionality Analysis of the FDA Adverse Event Reporting system	12
Ubrogepant and rimegepant: systematic review, meta-analysis, and meta-regression of clinical studies	12
An update on the safety of olaparib for treating ovarian cancer	12
Insights into efficacy and safety of dapagliflozin treatment for the management in older adults with type 2 diabetes: a systematic review and meta-analysis	12
Drug-induced dementia: a pharmacovigilance analysis of the FAERS database	11
Analysis of completeness for spontaneous reporting of disease-modifying therapies in multiple sclerosis	11
Sexual dysfunction with major depressive disorder and antidepressant treatments: impact, assessment, and management	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
A new paradigm in adverse drug reaction reporting: consolidating the evidence for an intervention to improve reporting	11
Adverse events of nusinersen: a real-world drug safety surveillance study based on the FDA adverse event reporting system (FAERS) database	11
Improving the data quality of spontaneous ADR reports: a practical example from Malta	11
Clinical profile of acute pancreatitis following treatment with protease inhibitors: a real-world analysis of post-marketing surveillance data	11
Adverse event of ruxolitinib cream: a real-world analysis based on FDA Adverse Event Reporting System from 2021 to 2024	10
The efficacy and safety of adjunctive intranasal esketamine treatment in major depressive disorder: a systematic review and meta-analysis	10
Safety assessment of ezetimibe: real-world adverse event analysis from the FAERS database	10
Safety evaluation of oliceridine for the management of postoperative moderate-to-severe acute pain	10
Identification of risk factors for gastrointestinal immune–related adverse events associated with immune check point inhibitors	10
Adverse drug events associated with metreleptin administration: a real-world pharmacovigilance study from 2014 to 2024 using the FAERS database	10
A reappraisal of the role of fever in the occurrence of neurological sequelae following lithium intoxication: a systematic review	9
Gastrointestinal and cardiovascular adverse events associated with NSAIDs	9
Antimicrobial resistance and the post antibiotic era: better late than never effort	9
Dupilumab in real-life settings: a review of adverse events and their pathogenesis	9
Association between cyclin-dependent kinase 4/6 inhibitors and venous thromboembolism: analysis of F.A.E.R.S. data	9
Comprehensive evaluation of post-approval regulatory actions during the drug lifecycle – a focus on benefits and risks	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

Thromboembolic events in younger women exposed to Pfizer-BioNTech or Moderna COVID-19 vaccines	9
Evaluating safety in hyaluronic acid lip injections	9
Immune checkpoint inhibitor-related myocarditis: current understanding and potential diagnostic and therapeutic strategies	9
Post-marketing safety of finerenone: a disproportionality analysis of the FDA adverse event reporting system	9
Preserving residual kidney function in persons on peritoneal dialysis: the role of pharmacotherapy	8
Safety issues of psilocybin and LSD as potential rapid acting antidepressants and potential challenges	8
Underuse of GLP-1 receptor agonists in the management of type 2 diabetes despite a favorable benefit-safety profile	8
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	8
Completeness of pharmaceutical industry insulin adverse event reports from Africa and the Middle East	8
Adverse events in patients with cardiovascular disease taking proton pump inhibitors	8
Analysis of hemorrhagic drug-drug interactions between P-gp inhibitors and direct oral anticoagulants from the FDA Adverse Event Reporting System	8
Assessment of adverse events related to anti-interleukin-6 receptor monoclonal antibodies using the FDA adverse event reporting system: a real-world pharmacovigilance study	8
Factors affecting persistence with biologic treatments in patients with rheumatoid arthritis: a systematic literature review	8
Infectious events in patients with alopecia areata treated with JAK inhibitors: low burden and minimal impact on persistence in treatment	8
Ocular adverse events associated with GLP-1 receptor agonists: a real-world study based on the FAERS database and network pharmacology	8
Infection and infestation-related adverse events of biologics in psoriasis: insights from the Food and Drug Administration Adverse Event Reporting System (FAERS)	8
The safety of phthalate-containing medications used during pregnancy	7
Safety profiles of tetracycline-class drugs: a pharmacovigilance analysis of the FAERS database	7
Post-marketing safety concerns with abrocitinib: a real-world pharmacovigilance analysis of the FDA adverse event reporting system	7
Evaluating potential unexpected adverse events and mortality after oral analgesics administration in fracture care-a cohort study	7
Fluoroquinolones-related psychiatric adverse events: a real‑world retrospective and pharmacovigilance database analysis	7
Efficacy and safety of biologics and small molecules for psoriasis in pediatric and geriatric populations. Part I: focus on pediatric patients	7
Real-world analysis of medications inducing meibomian gland dysfunction: based on the FDA adverse event reporting system database	7
A real-world pharmacovigilance analysis of the FDA adverse event reporting system events for polatuzumab vedotin	7
Antifungal agents and the kidney: pharmacokinetics, clinical nephrotoxicity, and interactions	7
Safety evaluation of the trastuzumab biosimilar in Iranian women with HER2-positive breast cancer undergoing adjuvant chemotherapy: a post-marketing surveillance	7
Analysis of clinical characteristics of terbinafine-induced subacute cutaneous lupus erythematosus	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
Comprehensive safety profile of dipeptidyl peptidase-4 inhibitors: a post-marketing study based on FAERS database using signal detection algorithms	7
Risk factors analysis and construction of predictive models for acute kidney injury in overweight patients receiving vancomycin treatment	7
Comparative evaluation of adverse drug reactions for tenofovir alafenamide and tenofovir disoproxil fumarate using the FAERS Database: a disproportionality analysis	7
Safety review of current pharmacotherapies for levodopa-treated patients with Parkinson’s disease	7
Managing the ADR of Stevens-Johnson syndrome/toxic epidermal necrolysis	7
A safety review of current monoclonal antibodies used to treat multiple sclerosis	7
Safety profile of lasmiditan: a retrospective post-marketing pharmacovigilance study based on the real-world data of FAERS database	7
A pharmacovigilance study assessing risk of angioedema with angiotensin receptor blockers using the US FDA Adverse Event Reporting System	7
Ocular adverse events associated with platins: a disproportionality analysis of pharmacovigilance data and extensive systematic review of case reports	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
Signal of dementia with proton pump inhibitor after minimizing competition bias: an updated disproportionality analysis	7
Safety of proteasome inhibitor drugs for the treatment of multiple myeloma post-marketing: a pharmacovigilance investigation based on the FDA adverse event reporting system	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
Inclisiran: a small interfering RNA strategy targeting PCSK9 to treat hypercholesterolemia	7
Exploration and evaluation of adverse event signals of droxidopa based on the FAERS database	7
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	7
Safety profile of isocitrate dehydrogenase inhibitors in cancer therapy: a pharmacovigilance study of the FDA Adverse Event Reporting System	7
What should clinicians know about the renal effect and the mechanism of action of levosimendan?	6
Long-term safety of ketamine and esketamine in treatment of depression	6
Reporting of tumor lysis syndrome with targeted therapy for hepatic cancer in the FDA adverse events reporting system	6
Risk of respiratory, thoracic, and mediastinal disorders associated with endothelin receptor antagonists and prostacyclin-related drugs in pulmonary hypertension: a disproportionality analysis based o	6
Drug-induced hepatitis B virus reactivation: insights from FAERS database analysis	6
Adverse events with pemigatinib in the real world: a pharmacovigilance study based on the FDA Adverse Event Reporting System	6
Nobel Prize for immune checkpoint inhibitors, understanding the immunological switching between immunosuppression and autoimmunity	6
The role of GLP-1 receptor agonists during COVID-19 pandemia: a hypothetical molecular mechanism	6
A pharmacovigilance analysis of FDA adverse event reporting system events for romosozumab	6
Comparative risk of infection of medications used for type 2 diabetes	6
Vortioxetine in major depressive disorder: from mechanisms of action to clinical studies. An updated review	6
Thromboembolism adverse event profiles of thrombopoietin receptor agonists: a real-world, pharmacovigilance study	6
TBC and COVID: an interplay between two infections	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
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	6
A safety review of recently approved and emerging drugs for patients with relapsed or refractory multiple myeloma	6
Model driven method for exploring individual and confounding effects in spontaneous adverse event reporting databases	6
Correction	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
Disproportionality analysis of adverse neurological and psychiatric reactions with the ChAdOx1 (Oxford-AstraZeneca) and BNT162b2 (Pfizer-BioNTech) COVID-19 vaccines in the United Kingdom	6
Exploring SGLT-2 inhibitors and sarcopenia in FAERS: a post-marketing surveillance study	5
Antibiotics-associated pseudomembranous colitis: a disproportionality analysis of the US food and drug administration adverse event reporting system (FAERS) database	5
The emerging role of Bruton’s tyrosine kinase inhibition in urticaria management	5
Disproportionality analysis of data from VigiBase and other global product safety databases on toxicity of iron chelating agents	5
Efficacy and safety of biological drugs in interstitial lung disease associated with connective tissue diseases	5
Drug-induced Stevens-Johnson syndrome: a disproportionality analysis from the pharmacovigilance database of the World Health Organization	5
Drug safety in thalassemia: lessons from the present and directions for the future	5
The burden of adverse drug reactions reported by patients in the Dutch ADR monitor: a proof of concept	5
Compartment syndrome associations with drugs: a pharmacovigilance study of the FDA adverse event reporting system (FAERS)	5
Signal mining and gender differences analysis of adverse events in NMIBC treatment with gemcitabine and BCG bladder instillation based on the FAERS database	5
Treatment-emergent Candida infections in patients with psoriasis, psoriatic arthritis, and axial spondyloarthritis treated with ixekizumab: an integrated safety analysis of 25 clinical studies	5
Biological therapies in infants and children younger than 6 years of age with atopic dermatitis: suitability and practical considerations	5
Comparison of four criteria for potentially inappropriate medications in older patients with newly diagnosed non-small cell lung cancer	5
Post-marketing safety of pimavanserin: a real-world pharmacovigilance study based on the FDA adverse event reporting system (FAERS)	5
A real-world pharmacovigilance study of FDA adverse event reporting system events for atogepant	5

Can the revival of serotonergic psychedelic drugs as treatments for mental disorders help to characterize their risks and benefits?	5
Combined nephrotoxicity of Polymyxins and Vancomycin: a study on adverse event reporting for monotherapy versus combinations using the FDA adverse event reporting system (FAERS)	5
Recommendations for the selection of nucleoside analogues as antihuman herpesvirus drugs: a real-world analysis of reported cases from the FDA adverse event reporting system	5
Catatonia related to tacrolimus: a real world pharmacovigilance study of FDA adverse event reporting system (FAERS) database	5
Clinical features, treatment, and prognosis of SGLT2 inhibitors induced acute pancreatitis	5
Real-world pharmacovigilance study of FDA adverse event reporting system events for finerenone	5
Real-world safety evaluation of brivaracetam: insights from the US FDA Adverse Event Reporting System	5
Adverse event profiles of drug-induced decreased libido: an assessment of the US food and drug administration Adverse Event Reporting System	5
Risk of acute kidney injury in patients receiving vancomycin and concomitant piperacillin-tazobactam or carbapenem: a multicenter, retrospective cohort study	5
Can COVID-19 have a clinically significant effect on drug metabolism?	5
Meeting report: an exploration into the scientific and regulatory aspects of pharmaceutical drug quality in the United States	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
Immune checkpoint inhibitor related myositis: an observational, retrospective, pharmacovigilance study	5
Assessment of the implementation of risk minimization measures for bosentan: a retrospective study	5
Hypercalcemia in children induced by denosumab: a case report and an analysis of the FDA adverse event reporting system database	5
OnabotulinumtoxinA for the prophylactic treatment of headaches in adult patients with chronic migraine: a safety evaluation	4
Safety of selinexor as the only exportin 1 (XPO1) inhibitor so far: a post-marketing study based on the world Health Organization pharmacovigilance database (Vigibase)	4
Reducing treatment toxicity in Waldenström macroglobulinemia	4
A safety evaluation of ruxolitinib for the treatment of polycythemia vera	4
Safety evaluation of axicabtagene ciloleucel for relapsed or refractory large B-cell lymphoma	4
Thromboembolism profiles associated with cyclin-dependent kinase 4/6 inhibitors: a real-world pharmacovigilance study and a systematic review	4
Malignant syndromes: current advances	4
Safety and efficacy of anti-SARS-CoV-2 monoclonal antibodies in pregnancy	4
Safety considerations with the use of platelet inhibitors for elderly patients with non-ST- elevation acute coronary syndrome	4
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	4
Angiotensin receptor-neprilysin inhibitor and sodium-dependent glucose cotransporter-2 inhibitor-associated renal injury: a pharmacovigilance study	4
An updated safety review of the drug treatments for idiopathic pulmonary fibrosis	4
Is there any clinical or laboratory predictive factor for cetuximab-induced skin toxicity?	4
Weight gain, gender, and antipsychotics: a disproportionality analysis of the FDA Adverse Event Reporting System database (FAERS)	4
Sex differences in adverse drug reactions from Adalimumab and etanercept in patients with inflammatory rheumatic diseases	4
Long QT syndrome after using EGFR-TKIs in older patients with advanced non-small cell lung cancer	4
Safety of ramucirumab treatment in patients with advanced hepatocellular carcinoma and elevated alpha-fetoprotein	4
Immune checkpoint inhibitors-induced diabetes mellitus: a growing clinical presentation requiring our attention	4
Direct oral anticoagulants toxicity in children: an overview and practical guide	4
Eye disorders associated with selective serotonin reuptake inhibitors: a real-world disproportionality analysis of FDA adverse event reporting system	4
The effect of patient sex on the efficacy and safety of anticancer immunotherapy	4
How can we manage the cardiac toxicity of immune checkpoint inhibitors?	4
An updated safety review of the current drugs for managing ADHD in children	4
New approaches to antipsychotic medication adherence – safety, tolerability and acceptability	4
Somatostatin analog-induced pancreatic exocrine insufficiency: exploring our diagnostic strategy	4
Efficacy and safety of deucravacitinib for the management of psoriasis: a drug safety evaluation	4
The therapeutic potential of psilocybin: a systematic review	4
A safety review of drug treatments for patients with systemic immunoglobulin light chain (AL) amyloidosis	4
Pre-therapeutic evaluation and practical management of cardiovascular and renal toxicities in patients with metastatic radioiodine-refractory thyroid cancer treated with lenvatinib	4
Drug-induced parkinsonism: diagnosis and treatment	4
Evaluating patient and physician knowledge of risks and safe use of rivaroxaban: a survey across four countries	4
Barriers and facilitators for systematically registering adverse drug reactions in electronic health records: a qualitative study with Dutch healthcare professionals	4
Capecitabine in treating patients with advanced, persistent, or recurrent cervical cancer: an active and safe option?	4