OOIR: Observatory of International Research

Papers

(The TQCC of Expert Opinion on Drug Safety is 5. The table below lists those papers that are above that threshold based on CrossRef citation counts [max. 250 papers]. The publications cover those that have been published in the past four years, i.e., from 2021-12-01 to 2025-12-01.)

Article	Citations
Novel insights into post-marketing AEs associated with bempedoic acid: a comprehensive analysis utilizing the FAERS database	114
Resistance to hedgehog inhibitors in basal cell carcinoma: strategies to adopt	93
Adverse event profiles of drug-induced decreased libido: an assessment of the US food and drug administration Adverse Event Reporting System	82
An update on the cognitive safety of antimuscarinics in the treatment of overactive bladder	75
Hypogammaglobulinemia and infections in patients with multiple sclerosis treated with anti-CD20 monoclonal antibodies: a systematic review and meta-analysis of observational studies	57
Drug-induced hepatitis B virus reactivation: insights from FAERS database analysis	49
Adverse events in patients with cardiovascular disease taking proton pump inhibitors	46
Exploration and evaluation of adverse event signals of droxidopa based on the FAERS database	44
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	42
Safety profile of isocitrate dehydrogenase inhibitors in cancer therapy: a pharmacovigilance study of the FDA Adverse Event Reporting System	42
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	32
Exploration of cardiac adverse events associated with relugolix and degarelix: a multi-center pharmacovigilance study based on the FAERS database	32
Assessment of adverse events related to anti-interleukin-6 receptor monoclonal antibodies using the FDA adverse event reporting system: a real-world pharmacovigilance study	30
Mechanism and clinical utility of abatacept in the treatment of rheumatoid arthritis	29
An updated safety review of Hidradenitis Suppurativa treatment options	27
Why is pharmacovigilance essential for biosimilars?	25
The safety of phthalate-containing medications used during pregnancy	25
Safety assessment of brexanolone in the FAERS database: real adverse event analysis and discussion of side effects	25
The role of artificial intelligence in pharmacovigilance for rare diseases	25
Long-term safety of ketamine and esketamine in treatment of depression	23
Assessment of adverse events of the novel antiepileptic drug lamotrigine: a real-world pharmacovigilance study based on FAERS	23
The safety profile of azithromycin in pediatrics: a pharmacovigilance disproportionality analysis	21
Underuse of GLP-1 receptor agonists in the management of type 2 diabetes despite a favorable benefit-safety profile	21
Infectious events in patients with alopecia areata treated with JAK inhibitors: low burden and minimal impact on persistence in treatment	21
Pharmacovigilance approaches to study rare and very rare side-effects: the example of clozapine-related DiHS/DRESS syndrome	19

The Impact of Medication Regimen Complexity Score on Multi-Organ Dysfunction and Clinical Outcomes in Critically Ill Patients: A Cohort Study	19
The effectiveness and safety of aripiprazole, bromocriptine, and cabergoline in the treatment of hyperprolactinemia: a systematic review and network meta-analysis	19
Diarrhea-predominant irritable bowel syndrome treatment options eluxadoline, rifaximin, and alosetron: analysis of the FDA adverse event reporting system (FAERS) database	18
A safety review of approved oral agents for treating type 2 diabetes and associated diseases in pregnant patients	18
Proton pump inhibitors and increased reporting odds of renal neoplasms: FAERS-based adverse event data mining and analysis	17
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	17
Safety and efficacy of anticoagulant administration in people with atrial fibrillation and advanced chronic kidney disease	17
Risk of acute kidney injury in patients receiving vancomycin and concomitant piperacillin-tazobactam or carbapenem: a multicenter, retrospective cohort study	17
Safety and efficacy of anti-SARS-CoV-2 monoclonal antibodies in pregnancy	17
Unveiling the hidden ocular risks of isotretinoin: a comprehensive FAERS-Based analysis	17
Newly identified adverse events of enzalutamide using the food and drug administration adverse event reporting system	17
Safety concerns associated with BACE1 inhibitors – past, present, and future	17
Correction	17
Update of safety profile of levonorgestrel: a disproportionality analysis based on FAERS from 2004 to 2023	16
Disease-specific ADRs of TNF-α inhibitors as reported by patients with inflammatory rheumatic diseases: a registry-based prospective multicenter cohort study	16
Corticosteroids for the treatment of Duchenne muscular dystrophy: a safety review	16
Sodium-glucose cotransporter-2 inhibitors and cardiovascular safety profile: a pharmacovigilance analysis of the US food and drug administration adverse event reporting system	16
A real-world disproportionality analysis of baloxavir marboxil: post-marketing pharmacovigilance data	16
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	16
Angioedema risk of thrombolytics: an integrated assessment using disproportionality analysis of the USFDA adverse event reporting system, case reviews and meta-analysis	15
SSRI withdrawal syndrome in children and adolescents: a narrative literature review	15
Post-marketing safety evaluation of zanubrutinib: a real-world pharmacovigilance analysis based on the FAERS database	14
Safety of intranasal corticosteroids for allergic rhinitis in children	14
Safety and effectiveness of empagliflozin in Japanese patients with type 2 diabetes: final results of a 3-year post-marketing surveillance study	14
Comparative analysis of CDKI-related adverse events in older patients: a real-world data from the FDA adverse event reporting system database	14
Hallucinations and delusions associated with Parkinson’s disease psychosis: safety of current treatments and future directions	14
Does the use of generative AI chatbots by patients introduce risk of adverse drug events?	14
Post-marketing safety concerns with palbociclib: a disproportionality analysis of the FDA adverse event reporting system	14
Gastrointestinal adverse events associated with immune checkpoint inhibitors: a pharmacovigilance analysis of the EudraVigilance and VigiAccess databases	13
Data mining for signal detection of adverse events for taxanes based on the food and drug administration adverse drug events reporting system database	13
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	13
Safety of current antiviral drugs for chronic hepatitis B	13
Tirzepatide and glucagon-like peptide-1 receptor agonists: safety always comes first!	13
Disproportionality analysis of the safety profile of rufinamide in the real world: an evaluation of the FDA Adverse Event Reporting System database	12
Anticoagulant-associated calciphylaxis: analysis of USFDA adverse event report system and clinical feature analysis of reported cases	12
Exploration of the clinical characteristics and potential mechanisms of liver injury induced by proton pump inhibitors	12
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	12
A real-world pharmacovigilance study of axitinib: data mining of the public version of FDA adverse event reporting system	12
Antibody-drug conjugates-related interstitial lung diseases: data mining of the FAERS database	12
Long-term safety of lanthanum carbonate in the real word: a 19-year disproportionality analysis from the FDA Adverse Event Reporting System	12
Data pharmacovigilance analysis of medroxyprogesterone-related adverse events in the FDA adverse event reporting system	12
Differences in safety profiles of anti-herpesvirus medications: a real-world pharmacovigilance study based on the FAERS database	12
Influence factors of metronidazole-related CNS disorders: an analysis of the Japan adverse drug event report and FDA adverse event reporting system	12
Association between dual orexin receptor antagonists (DORAs) and suicidality: reports to the United States Food and Drug Administration Adverse Event Reporting System (FAERS)	12
Safety considerations for drugs newly approved for treating acute myeloid leukemia	12
Assessment of adverse events of tasimelteon: a real-world pharmacovigilance study based on FAERS	12
Drug-induced myocarditis: a real-world pharmacovigilance study using the FDA adverse event reporting system database	12
The use of hydroxyurea in the real life of MIOT network: an observational study	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

Long-term safety profile and secondary effectiveness of canakinumab in pediatric rheumatic diseases: a single-center experience	12
Drug safety evaluation of ixekizumab for psoriasis: a review of the current knowledge	12
Vancomycin and linezolid: severe cutaneous adverse reactions to drugs	11
Comparative effectiveness and safety of drug therapy for chronic urticaria: a network meta-analysis and risk-benefit assessment	11
How do safety warnings on medicines affect prescribing?	11
Adverse events associated with acute pancreatitis caused by immune checkpoint inhibitors: a pharmacovigilance analysis of the FDA adverse event reporting system (FAERS) database	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 erectile dysfunction: a real-world pharmacovigilance study using the FDA adverse event reporting system database	11
Current safety concerns about the use of antiseizure medications in pregnancy	11
Adverse events associated with inclisiran: a real-world disproportionality analysis based on the FAERS database	10
Congenital anomalies associated with the use of cardiovascular drugs during pregnancy: a large-scale data analysis from the FAERS database	10
Hemorrhage profile associated with immune checkpoint inhibitors: a systematic review and a real-world study based on the FAERS database	10
Updated insights on levetiracetam-associated severe cutaneous adverse reactions: a real-world pharmacovigilance analysis	10
Drug-induced hyperacusis: a disproportionality analysis of the FAERS database	10
Analysis of the relationship between histamine H1 receptor antagonists and broad dementia events using the FAERS, JADER, and CVAR databases	9
Impact of preoperative pharmaceutical care consultation on medication errors in surgical patients: a comprehensive analysis	9
Will the future of pharmacovigilance be more automated?	9
Adverse events associated with aromatase inhibitors: an analysis of real-world datasets and drug-gene interaction network	9
Detection of risk signals for ustekinumab in the real world using the FDA Adverse Event Reporting System (FAERS)	9
A real‑world pharmacovigilance study of FDA adverse event reporting system events for daratumumab	9
Safety evaluation of ILaris: a real-world analysis of adverse events based on the FAERS database	9
Adverse events of direct factor Xa inhibitors: a disproportionality analysis of the FAERS database	9
The importance and utility of post market drug safety monitoring in cancer therapy	9
Ocular toxicities associated with antibody drug conjugates and immunotherapy in oncology: clinical presentation, pathogenesis, and management strategies	9
Treating psychosis in people with Parkinson’s disease	9
Potential drugs for reducing the occurrence of immune checkpoint inhibitor-induced interstitial lung disease: an exploratory study using the JADER and FAERS databases	9
Adverse event signal analysis of type Ib MET tyrosine kinase inhibitors based on food and drug administration adverse event reporting system	9
Adverse event profile of ocular injury associated with JAK inhibitors in patients with rheumatoid arthritis: a disproportionality analysis	9
A review on side effect management of second-generation antipsychotics to treat schizophrenia: a drug safety perspective	8
What’s in a name? What shall we call xanomeline-trospium combination?	8
The Safety, Efficacy, and Clinical Use of Novel Once-Weekly Insulins in the Management of Diabetes	8
Drug-induced dementia: a pharmacovigilance analysis of the FAERS database	8
Biosimilars and immunogenicity: a matter of concern?	8
Comparing musculoskeletal and connective tissue disorder risks of teriparatide and abaloparatide in osteoporosis: an analysis based on FDA adverse event reporting system (FAERS)	8
Skin cancer associated with calcineurin inhibitors treatment: analysis of FAERS database	8
Completeness of pharmaceutical industry insulin adverse event reports from Africa and the Middle East	8
Utility and limitations of the FDA adverse events reporting system public dashboard for safety analyses: a case study with vesicular monoamine transporter 2 inhibitors	8
Reply to Letter to the Editor regarding “Drug-induced noninfectious myocarditis: a disproportionality analysis of the FAERS database”	8
Investigating bleeding adverse events associated with BTK inhibitors in the food and drug administration adverse event reporting system (FAERS)	8
COVID-19 vaccine safety studies- the need for a third group for extended monitoring	8
Generic pharmaceuticals, regulatory aspects, bioequivalence investigation, and perception	8
Risk factors analysis and construction of predictive models for acute kidney injury in overweight patients receiving vancomycin treatment	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
Effects of adding adjuvants to propofol on the post-anesthesia cognitive function in patients undergoing gastroscopy/colonoscopy: a systematic review and meta-analysis	7
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	7
Reporting of tumor lysis syndrome with targeted therapy for hepatic cancer in the FDA adverse events reporting system	7
Comparison of four criteria for potentially inappropriate medications in older patients with newly diagnosed non-small cell lung cancer	7
Seizures associated with antibiotics: a real-world disproportionality analysis of FAERS database	7
Safety evaluation of secukinumab in pediatric patients with plaque psoriasis	7
Safety of medications for hereditary angioedema during pregnancy and lactation	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
Definition of treatment resistant psoriasis and related safety concerns	7
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	7
Ocular adverse events of cenegermin used in neurotrophic keratopathy: an analysis of the FDA adverse event reporting system database	7
Hepatobiliary disorders and Direct-Acting Antiviral (DAA) therapies: real-world evidence and insights from the EudraVigilance database	7
Study on analgesic-induced endocrine gland damage and its potential mechanisms	7
Cognitive dysfunction following finasteride use: a disproportionality analysis of the global pharmacovigilance database	7
Safety profiles of tetracycline-class drugs: a pharmacovigilance analysis of 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
Efficacy and safety of biologics and small molecules for psoriasis in pediatric and geriatric populations. Part I: focus on pediatric patients	7
Real-world safety evaluation of brivaracetam: insights from the US FDA Adverse Event Reporting System	7
Nobel Prize for immune checkpoint inhibitors, understanding the immunological switching between immunosuppression and autoimmunity	7
A new paradigm in adverse drug reaction reporting: consolidating the evidence for an intervention to improve reporting	6
An update on the safety of ixazomib for the treatment of multiple myeloma	6
Safety issues of psilocybin and LSD as potential rapid acting antidepressants and potential challenges	6
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	6
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	6
The therapeutic potential of psilocybin: a systematic review	6
Signal mining and gender differences analysis of adverse events in NMIBC treatment with gemcitabine and BCG bladder instillation based on the FAERS database	6
Oral isotretinoin for acne: a complete overview	6
Adverse events associated with inclisiran: a real-world pharmacovigilance study of FDA adverse event reporting system (FAERS)	6
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	6
Dupilumab in real-life settings: a review of adverse events and their pathogenesis	6
Opioid-related adverse drug events in surgical patients: risk factors and association with clinical outcomes	6
Letter to the Editor in response to: “Drug-induced noninfectious myocarditis: a disproportionality analysis of the FAERS database”	6
Can the revival of serotonergic psychedelic drugs as treatments for mental disorders help to characterize their risks and benefits?	6
Post-marketing safety surveillance of Amivantamab: a real world study based on the FDA adverse event reporting system	6
Concomitant use of sodium-glucose co-transporter 2 inhibitors and metformin and the risk of osteomyelitis reporting: a disproportionality analysis based on FAERS database	6
Correction	6
Meeting report: an exploration into the scientific and regulatory aspects of pharmaceutical drug quality in the United States	6

Drug-induced nephrolithiasis: a real-world pharmacovigilance study of the FDA Adverse Event Reporting System	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
Drug-induced Stevens-Johnson syndrome: a disproportionality analysis from the pharmacovigilance database of the World Health Organization	6
Comparative evaluation of adverse drug reactions for tenofovir alafenamide and tenofovir disoproxil fumarate using the FAERS Database: a disproportionality analysis	6
Cardiovascular adverse events associated with EGFR and HER2 dual TKIs: a pharmacovigilance study based on the FAERS database	6
A real-world pharmacovigilance study of blinatumomab based on the FDA adverse event reporting system	6
Barriers and facilitators for systematically registering adverse drug reactions in electronic health records: a qualitative study with Dutch healthcare professionals	6
Immune checkpoint inhibitor related myositis: an observational, retrospective, pharmacovigilance study	6
Investigating the risk of deep vein thrombosis with JAK inhibitors: a disproportionality analysis using FDA Adverse Event Reporting System Database (FAERS)	6
Postmarketing safety of [ ¹⁷⁷ Lu]Lu-PSMA-617 radioligand therapy for prostate cancer: a disproportionality analysis of the FDA adverse event reporting system	6
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	5
Incidence, clinical characteristics and related drugs analyzing of drug-induced movement disorders in 102914 inpatients: a retrospective real-world study	5
Injection site reactions resulting from the use of biological therapy in the treatment of moderate-to-severe plaque psoriasis	5
Analyzing the patterns of adverse drug reactions due to anti-infectives from large-scale nationwide database in Thailand	5
The safety and efficacy of sugammadex for reversing neuromuscular blockade in younger children and infants	5
Quality of life in ovarian cancer patients treated with bevacizumab: a meta-analysis	5
Comparative safety review of antithrombotic treatment options for patients with atrial fibrillation undergoing percutaneous coronary intervention	5
Post-marketing safety assessment of constipation drugs: a real-world pharmacovigilance study based on FAERS database	5
Appropriateness of psychopharmacological therapies to psychiatric diagnoses in persons with autism spectrum disorder with or without intellectual disabilities: a cross-sectional analytic study	5
PD-1/PD-L1 inhibitors-associated cardiac adverse events: a retrospective and real-world study based on the FDA Adverse Event Reporting System (FAERS)	5
Pharmacovigilance insights into drug-induced cystitis: analysis of FDA data from 2004 to 2024	5
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	5
Pre- and post-operative safety considerations for patients undergoing percutaneous nephrolithotomy	5
Approved treatments for neovascular age-related macular degeneration: current safety and future directions	5
Assessment of safety profile of ivabradine in real-world scenario using FDA adverse event reporting system database	5
Risk factors, prevention and treatment of weight gain associated with the use of antidepressants and antipsychotics: a state-of-the-art clinical review	5
Potential side effects of currently available pharmacotherapies in male lower urinary tract symptoms suggestive of benign prostatic hyperplasia	5
Compared of efficacy and safety of high-dose donepezil vs standard-dose donepezil among elderly patients with Alzheimer’s disease: a systematic review and meta-analysis	5
Safety analysis of fluoroquinolone drugs in elderly patients over 65 based on FAERS	5
Suspected statin-related adverse drug reactions: analysis of spontaneous reports in Hubei Province, China (2014–2022)	5
Hematopoietic adverse events associated with PARP inhibitors: A FAERS database study	5
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	5
A comparative analysis of the safety profiles between inclisiran and other PCSK9 inhibitors from real-world evidence – what have we learned recently?	5
Correction	5
Comparison of safety of acetaminophen and ibuprofen in minors: based on the FAERS database	5
The safety of available pharmacotherapy for stroke prevention in atrial fibrillation	5
Safeguarding drug safety in neonates: addressing the impact of in-hospital medication administration errors through prevention and standardization	5
Characteristics of adverse drug reactions induced by flutamide and bicalutamide: a real-world pharmacovigilance study using FAERS	5
Safety assessment of tafamidis: a real-world adverse event analysis from the FAERS database	5
Post-marketing safety of panitumumab: a real-world pharmacovigilance study	5
Dalbavancin in the treatment of acute bacterial skin and skin structure and other infections: a safety evaluation	5
Infectious complications associated with immune and targeted anti-cancer therapies: a retrospective study of the FDA adverse events reporting system (FAERS)	5
Safety of PARP inhibitors as maintenance therapy in ovarian cancer	5
A real-world pharmacovigilance case/non-case study of FDA adverse event reporting system events for mannitol	5
Neural dysfunction, inflammatory disorder, and metabolic interference feature in amantadine-related adverse drug events: a perspective from FAERS and network toxicology	5
A narrative review of the comparative safety of disease-modifying anti-rheumatic drugs used for the treatment of rheumatoid arthritis	5
Management of refractory checkpoint inhibitor-induced colitis	5