Results 61 to 70 of about 9,302 (232)

Dipeptidyl Peptidase-4 Inhibitor–Associated Pancreatic Carcinoma: A Review of the FAERS Database

, 2016
BACKGROUND: To date, there is limited literature regarding the association between dipeptidyl peptidase-4 (DPP-4) inhibitors and pancreatic carcinoma.
Werner, Paul M, Ahmed-Sarwar, Nabila, Brown, Jack, Nagel, Angela, Van Manen, Robbert P, Cipriano, Gabriela   +5 more
core   +1 more source

Pediatric Developmental Safety Assessment: Are We Ready for the Next Thalidomide?

Clinical Pharmacology &Therapeutics, Volume 120, Issue 5, Page 1169-1172, November 2026.
Pediatric drug development has achieved remarkable success in the last 20 years with over 1,000 products studied in pediatric patients. This success has been driven in part by an increased understanding of pediatric disease processes. The aspect that has been largely overlooked is the potential adverse effect of new drugs on pediatric developmental ...
Gilbert J. Burckart, Susan M. Abdel‐Rahman, Gelareh Abulwerdi, Sherbet Samuels, Rebecca Racz, Mohamed A. Mohamoud, Nicholas P. Tatonetti   +6 more
wiley   +1 more source

The Impact of the Sentinel Initiative and FAERS Surveillance System on Consumer Safety [PDF]

, 2016
The U.S. Food and Drug Administration (FDA) uses the FDA Adverse Event Reporting System (FAERS) to monitor adverse events resulting from pharmaceutical drug use. However, this system has limitations such as not allowing real-time data collection.
Batra, Sonia
core  

Characterization of ocular adverse events associated with crizotinib: real-world insights from the two global pharmacovigilance databases of FAERS and VigiBase

Frontiers in Oncology
To evaluate the risk of ocular adverse events (AEs) associated with crizotinib using real-world data from FAERS and VigiBase, and to characterize signal patterns through disproportionality and time-to-onset (TTO) analyses. Reports from FAERS and VigiBase
Shuai Dong, Zhi-chao Jiang, Li Gao, Rong Zhang, Yan Liu   +4 more
doaj   +1 more source

Pediatric Developmental Safety Assessment and New Approach Methodologies: US FDA/Triangle CERSI Workshop Report

Clinical Pharmacology &Therapeutics, Volume 120, Issue 5, Page 1240-1249, November 2026.
Pediatric developmental safety assessment presents distinct challenges in drug development. Children undergo dynamic changes in organ systems and drug disposition pathways during development, and drug‐related effects may be delayed or manifested differently than in adults.
Gilbert J. Burckart, Gelareh Abulwerdi, Christin L. Daniels, Calib Choi, Rebecca Racz, Jean‐Pierre Valentin, Kristin Ardlie, Nicholas Tatonetti, Susan Laffan, Marjory Moreau, Will Redfern, Lang Li, James J. Hickman, Rajanikanth Madabushi, Bhagwat Prasad, Lynne Yao, Paul B. Watkins   +16 more
wiley   +1 more source

Antihypertensives and Skin Cancer: Evidence from FAERS

This is the supplemental materials for the manuscript “Antihypertensives and Skin Cancer: Evidence from FAERS” published in Journal of the American Academy of ...
Meng, Long
core   +1 more source

Semaglutide and Panic Attacks: Active‐Comparator Disproportionality Analysis, Temporal Assessment of Notoriety Bias and Evidence Triangulation in Post‐Marketing Pharmacovigilance

Pharmacoepidemiology and Drug Safety, Volume 35, Issue 11, November 2026.
ABSTRACT Purpose To evaluate how confounding by indication and notoriety bias shape the apparent semaglutide–panic attack signal in the FDA Adverse Event Reporting System (FAERS) and to interpret this signal using an evidence‐triangulation framework integrating randomized and observational studies.
Ben Melamed, Mahak Parsi‐Zahabi, Mohammad Ali Omrani, Bala Swetha Baskaran, Lujain Ez Eddin, Nazgol Kermanshahi, Niaz Chalabianloo, Flory Tsobo Muanda   +7 more
wiley   +1 more source

Annual distribution of AE reports for TXA in FAERS.

Annual distribution of AE reports for TXA in FAERS.
Jing Feng (177843), Chiwei Guo (22569722), Shujuan Zhao (6317975)   +2 more
core   +1 more source

Hepatobiliary disorders associated with TNF-α inhibitors: a pharmacovigilance analysis of FAERS and JADER

Frontiers in Immunology
IntroductionTumor necrosis factor-a (TNF-a) inhibitors are widely used for immune-mediated diseases. Their systemic adverse events (AEs) have become increasingly prominent. The hepatobiliary risks of different TNF-a inhibitors were compared in this paper
Hongyu Chen, Shirui Jiang, Jingyu Wang, Ailin Zhang, Liqin Zhu   +4 more
doaj   +1 more source

Drug Safety During Breastfeeding: A Comparative Analysis of FDA Adverse Event Reports and LactMed^®

Pharmaceuticals
Background/Objectives: While breastfeeding is highly recommended, breastfed infants may be exposed to drugs by milk due to maternal pharmacotherapy, resulting in a risk of adverse drug events (ADE) or reactions (ADRs). The U.S.
Hülya Tezel Yalçın, Nadir Yalçın, Michael Ceulemans, Karel Allegaert   +3 more
doaj   +1 more source