The Medical Dictionary for Regulatory Activities (MedDRA)

Zoledronic Acid and Clinical Fractures and Mortality after Hip Fracture

Lyles, K. W., Colón-Emeric, C. S., Magaziner, J. S., Adachi, J. D., Pieper, C. F., Mautalen, C., Hyldstrup, L., Recknor, C., Nordsletten, L., Moore, K. A., et al. (2007) · New England Journal of Medicine · doi:10.1056/nejmoa074941 · Cited by 2,003

Febuxostat Compared with Allopurinol in Patients with Hyperuricemia and Gout

Becker, M. A., Schumacher, H. R., Wortmann, R. L., MacDonald, P. A., Eustace, D., Palo, W. A., Streit, J., & Joseph-Ridge, N. (2005) · New England Journal of Medicine · doi:10.1056/nejmoa050373 · Cited by 1,357

Rucaparib in relapsed, platinum-sensitive high-grade ovarian carcinoma (ARIEL2 Part 1): an international, multicentre, open-label, phase 2 trial

Swisher, E. M., Lin, K. K., Oza, A. M., Scott, C. L., Giordano, H., Sun, J., Konecny, G. E., Coleman, R. L., Tinker, A. V., O'Malley, D. M., et al. (2017) · The Lancet Oncology · doi:10.1016/s1470-2045(16)30559-9 · Cited by 1,196

Preliminary Findings of mRNA Covid-19 Vaccine Safety in Pregnant Persons

Shimabukuro, T. T., Kim, S. Y., Myers, T. R., Moro, P. L., Oduyebo, T., Panagiotakopoulos, L., Marquez, P. L., Olson, C. K., Liu, R., Chang, K. T., et al. (2021) · New England Journal of Medicine · doi:10.1056/nejmoa2104983 · Cited by 927

Rucaparib in Men With Metastatic Castration-Resistant Prostate Cancer Harboring a BRCA1 or BRCA2 Gene Alteration

Abida, W., Patnaik, A., Campbell, D., Shapiro, J., Bryce, A. H., McDermott, R., Sautois, B., Vogelzang, N. J., Bambury, R. M., Voog, E., et al. (2020) · Journal of Clinical Oncology · doi:10.1200/jco.20.01035 · Cited by 694

LOINC, a Universal Standard for Identifying Laboratory Observations: A 5-Year Update

McDonald, C. J., Huff, S. M., Suico, J. G., Hill, G., Leavelle, D., Aller, R., Forrey, A., Mercer, K., DeMoor, G., Hook, J., et al. (2003) · Clinical Chemistry · doi:10.1373/49.4.624 · Cited by 579

Zoledronic acid and risedronate in the prevention and treatment of glucocorticoid-induced osteoporosis (HORIZON): a multicentre, double-blind, double-dummy, randomised controlled trial

Reid, D. M., Devogelaer, J.-P., Saag, K., Roux, C., Lau, C.-S., Reginster, J.-Y., Papanastasiou, P., Ferreira, A., Hartl, F., Fashola, T., et al. (2009) · The Lancet · doi:10.1016/s0140-6736(09)60250-6 · Cited by 527

High Rates of Adverse Drug Events in a Highly Computerized Hospital

(2005) · Archives of Internal Medicine · doi:10.1001/archinte.165.10.1111 · Cited by 363

HORIZON: an open-label extension trial of ranibizumab for choroidal neovascularization secondary to age-related macular degeneration

Singer, M. A., Awh, C. C., Sadda, S., Freeman, W. R., Antoszyk, A. N., Wong, P., & Tuomi, L. (2012) · Ophthalmology · doi:10.1016/j.ophtha.2011.12.016 · Cited by 356

Information retrieval and text mining technologies for chemistry

Krallinger, M., Rabal, O., Lourenço, A., Oyarzabal, J., & Valencia, A. (2017) · Chemical Reviews · doi:10.1021/acs.chemrev.6b00851 · Cited by 281

Islet transplantation versus insulin therapy in patients with type 1 diabetes with severe hypoglycaemia or poorly controlled glycaemia after kidney transplantation (TRIMECO): a multicentre, randomised controlled trial

Lablanche, S., Vantyghem, M.-C., Kessler, L., Wojtusciszyn, A., Borot, S., Thivolet, C., Girerd, S., Bosco, D., Bosson, J.-L., Colin, C., et al. (2018) · The Lancet Diabetes & Endocrinology · doi:10.1016/s2213-8587(18)30078-0 · Cited by 200

Efficacy and tolerability of zonisamide versus controlled-release carbamazepine for newly diagnosed partial epilepsy: a phase 3, randomised, double-blind, non-inferiority trial

Baulac, M., Brodie, M. J., Patten, A., Segieth, J., & Giorgi, L. (2012) · The Lancet Neurology · doi:10.1016/s1474-4422(12)70105-9 · Cited by 186

Efficacy and safety of vortioxetine (Lu AA21004), 15 and 20 mg/day: a randomized, double-blind, placebo-controlled, duloxetine-referenced study in the acute treatment of adult patients with major depressive disorder

Boulenger, J.-P., Loft, H., & Olsen, C. K. (2014) · International Clinical Psychopharmacology · doi:10.1097/yic.0000000000000018 · Cited by 176

An enriched-enrolment, randomized withdrawal, flexible-dose, double-blind, placebo-controlled, parallel assignment efficacy study of nabilone as adjuvant in the treatment of diabetic peripheral neuropathic pain

Toth, C., Mawani, S., Brady, S., Chan, C., Liu, C., Mehina, E., Garven, A., Bestard, J., & Korngut, L. (2012) · Pain · doi:10.1016/j.pain.2012.06.024 · Cited by 174

Number needed to treat (NNT) in clinical literature: an appraisal

Mendes, D., Alves, C., & Batel-Marques, F. (2017) · BMC Medicine · doi:10.1186/s12916-017-0875-8 · Cited by 169

A big data approach to the concordance of the toxicity of pharmaceuticals in animals and humans

Clark, M., & Steger-Hartmann, T. (2018) · Regulatory Toxicology and Pharmacology · doi:10.1016/j.yrtph.2018.04.018 · Cited by 162

A Randomized Controlled Trial of Venlafaxine ER Versus Placebo in Pediatric Social Anxiety Disorder

March, J. S., Entusah, A. R., Rynn, M., Albano, A. M., & Tourian, K. A. (2007) · Biological Psychiatry · doi:10.1016/j.biopsych.2007.02.025 · Cited by 156

Antidepressant side effects and their impact on treatment outcome in people with major depressive disorder: an iSPOT-D report

Braund, T. A., Tillman, G., Palmer, D. M., Gordon, E., Rush, A. J., & Harris, A. W. F. (2021) · Translational Psychiatry · doi:10.1038/s41398-021-01533-1 · Cited by 135

Cardiovascular Adverse Events Reported from COVID-19 Vaccines: A Study Based on WHO Database

Kaur, R., Dutta, S., Charan, J., Bhardwaj, P., Tandon, A., Yadav, D., Islam, S., & Haque, M. (2021) · International Journal of General Medicine · doi:10.2147/ijgm.s324349 · Cited by 125

Effects of 28-day Bifidobacterium animalis subsp. lactis HN019 supplementation on colonic transit time and gastrointestinal symptoms in adults with functional constipation: A double-blind, randomized, placebo-controlled, and dose-ranging trial

Ibarra, A., Latreille-Barbier, M., Donazzolo, Y., Pelletier, X., & Ouwehand, A. C. (2018) · Gut Microbes · doi:10.1080/19490976.2017.1412908 · Cited by 121

GLP-1 receptor agonist-associated tumor adverse events: A real-world study from 2004 to 2021 based on FAERS

Yang, Z., Lv, Y., Yu, M., Mei, M., Xiang, L., Zhao, S., & Li, R. (2022) · Frontiers in Pharmacology · doi:10.3389/fphar.2022.925377 · Cited by 120

Safety and tolerability of prescription omega-3 fatty acids: A systematic review and meta-analysis of randomized controlled trials

Chang, C.-H., Tseng, P.-T., Chen, N.-Y., Lin, P.-C., Lin, P.-Y., Chang, J. P. C., Kuo, F.-Y., Lin, J., Wu, M.-C., & Su, K.-P. (2018) · Prostaglandins Leukotrienes and Essential Fatty Acids · doi:10.1016/j.plefa.2018.01.001 · Cited by 103

Systematic review and meta-analysis of vagus nerve stimulation in the treatment of depression: variable results based on study designs

Martin, J. L. R., & Martín-Sánchez, E. (2012) · European Psychiatry · doi:10.1016/j.eurpsy.2011.07.006 · Cited by 102

A multicenter, retrospective medical record review of X-linked myotubular myopathy: The recensus study

Beggs, A. H., Byrne, B. J., De Chastonay, S., Haselkorn, T., Hughes, I., James, E. S., Kuntz, N. L., Simon, J., Swanson, L. C., Yang, M. L., et al. (2018) · Muscle & Nerve · doi:10.1002/mus.26018 · Cited by 83

Study of serious adverse drug reactions using FDA-approved drug labeling and MedDRA

Wu, L., Ingle, T., Liu, Z., Zhao-Wong, A., Harris, S., Thakkar, S., Zhou, G., Yang, J., Xu, J., Mehta, D., et al. (2019) · BMC Bioinformatics · doi:10.1186/s12859-019-2628-5 · Cited by 80

Benefit and harm of intensive blood pressure treatment: Derivation and validation of risk models using data from the SPRINT and ACCORD trials

Basu, S., Sussman, J. B., Rigdon, J., Steimle, L., Denton, B. T., & Hayward, R. A. (2017) · PLOS Medicine · doi:10.1371/journal.pmed.1002410 · Cited by 77

Moderate-to-severe eosinophilia induced by treatment with immune checkpoint inhibitors: 37 cases from a national reference center for hypereosinophilic syndromes and the French pharmacovigilance database

Scanvion, Q., Béné, J., Gautier, S., Grandvuillemin, A., Le Beller, C., Chenaf, C., Etienne, N., Brousseau, S., Cortot, A. B., Mortier, L., et al. (2020) · OncoImmunology · doi:10.1080/2162402x.2020.1722022 · Cited by 59

A review of the explainability and safety of conversational agents for mental health to identify avenues for improvement

Sarkar, S., Gaur, M., Chen, L. K., Garg, M., & Srivastava, B. (2023) · Frontiers in Artificial Intelligence · doi:10.3389/frai.2023.1229805 · Cited by 38

Incretin-based drugs and intestinal obstruction: A pharmacovigilance study

Gudin, B., Ladhari, C., Robin, P., Laroche, M.-L., Babai, S., Hillaire-Buys, D., & Faillie, J.-L. (2020) · Therapies · doi:10.1016/j.therap.2020.02.024 · Cited by 37

Prediction of clinical risks by analysis of preclinical and clinical adverse events

Clark, M. (2015) · Journal of Biomedical Informatics · doi:10.1016/j.jbi.2015.02.008 · Cited by 36

Analysis of Neurological Adverse Events Reported in VigiBase From COVID-19 Vaccines

Dutta, S., Kaur, R., Charan, J., Bhardwaj, P., Ambwani, S. R., Babu, S., Goyal, J. P., & Haque, M. (2022) · Cureus · doi:10.7759/cureus.21376 · Cited by 36

Safety profile of semaglutide versus placebo in the SELECT study: a randomized controlled trial

Kushner, R. F., Ryan, D. H., Deanfield, J., Kokkinos, A., Cercato, C., Wilding, J., Burguera, B., Wu, C., Craciun, A., Pall, D., et al. (2025) · Obesity · doi:10.1002/oby.24222 · Cited by 35

Hepatotoxicity Related to Agomelatine and Other New Antidepressants: A Case/Noncase Approach With Information From the Portuguese, French, Spanish, and Italian Pharmacovigilance Systems

Montastruc, F., Scotto, S., Vaz, I. R., Guerra, L. N., Escudero, A., Sáinz, M., Falomir, T., Bagheri, H., Herdeiro, M. T., Venegoni, M., et al. (2014) · Journal of Clinical Psychopharmacology · doi:10.1097/jcp.0000000000000094 · Cited by 33

Deep learning prediction of chemical-induced dose-dependent and context-specific multiplex phenotype responses and its application to personalized alzheimer’s disease drug repurposing

Wu, Y., Liu, Q., Qiu, Y., & Xie, L. (2022) · PLOS Computational Biology · doi:10.1371/journal.pcbi.1010367 · Cited by 34

Algorithmovigilance, lessons from pharmacovigilance

Balendran, A., Benchoufi, M., Evgeniou, T., & Ravaud, P. (2024) · npj Digital Medicine · doi:10.1038/s41746-024-01237-y · Cited by 34

Examining the nocebo effect of statins through statin adverse events reported in the food and drug administration adverse event reporting system

Moon, J., Cohen Sedgh, R., & Jackevicius, C. A. (2021) · Circulation: Cardiovascular Quality and Outcomes · doi:10.1161/circoutcomes.120.007480 · Cited by 33

The need for guardrails with large language models in pharmacovigilance and other medical safety critical settings

Hakim, J. B., Painter, J. L., Ramcharran, D., Kara, V., Powell, G., Sobczak, P., Sato, C., Bate, A., & Beam, A. (2025) · Scientific Reports · doi:10.1038/s41598-025-09138-0 · Cited by 32

Efficacy of lisdexamfetamine dimesylate in children with attention-deficit/hyperactivity disorder previously treated with methylphenidate: a post hoc analysis

Jain, R., Babcock, T., Burtea, T., Dirks, B., Adeyi, B., Scheckner, B., & Lasser, R. (2011) · Child and Adolescent Psychiatry and Mental Health · doi:10.1186/1753-2000-5-35 · Cited by 26

Machine learning-based identification and rule-based normalization of adverse drug reactions in drug labels

Tiftikci, M., Özgür, A., He, Y., & Hur, J. (2019) · BMC Bioinformatics · doi:10.1186/s12859-019-3195-5 · Cited by 23

Disproportionality analysis of adverse neurological and psychiatric reactions with the ChAdOx1 (Oxford-AstraZeneca) and BNT162b2 (Pfizer-BioNTech) COVID-19 vaccines in the United Kingdom

Otero-Losada, M., Petrovsky, N., Alami, A., Crispo, J. A., Mattison, D., Capani, F., Goetz, C., Krewski, D., & Perez-Lloret, S. (2023) · Expert Opinion on Drug Safety · doi:10.1080/14740338.2022.2120607 · Cited by 22

Safety reporting in clinical trials

Kohl, K. S., & Bonhoeffer, J. (2001) · JAMA · doi:10.1001/jama.285.16.2076 · Cited by 20

Hepatotoxicity associated with agomelatine and other antidepressants: Disproportionality analysis using pooled pharmacovigilance data from the Uppsala Monitoring Centre

Gahr, M., Zeiss, R., Lang, D., Connemann, B. J., & Schönfeldt‐Lecuona, C. (2015) · The Journal of Clinical Pharmacology · doi:10.1002/jcph.475 · Cited by 14

Trends in reporting drug-associated liver injuries in Taiwan: a focus on amiodarone

Ye, J.-H., Ho, Y.-F., On, A. W.-F., Chen, W.-W., Huang, Y.-M., Huang, W.-I., & Tang, Y.-W. (2018) · International Journal of Clinical Pharmacy · doi:10.1007/s11096-018-0698-5 · Cited by 10

Combining varenicline preloading with Acceptance and Commitment Therapy (ACT) in persons with serious mental illness who smoke: The randomized ACTSLow pilot feasibility trial

Anthenelli, R. M., McKenna, B. S., Giannini, J., Attaluri, S. V., Rubin, M., O’Crowley, E., Miller, S., & Heffner, J. L. (2023) · Drug and Alcohol Dependence · doi:10.1016/j.drugalcdep.2023.111012 · Cited by 2

Structured prompt interrogation and recursive extraction of semantics (SPIRES): A method for populating knowledge bases using zero-shot learning

Caufield, J. H., Hegde, H., Emonet, V., Harris, N. L., Joachimiak, M. P., Matentzoglu, N., Kim, H., Moxon, S. A. T., Reese, J. T., Haendel, M. A., et al. (2023) · arXiv · doi:10.48550/arxiv.2304.02711