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Individual Drug Analyses

This page contains a complete list of all FDA analyses conducted in the Sentinel System from the start of Mini-Sentinel in 2009 to the present. 

The table below is organized at the individual analysis level (e.g., Level 1, Level 2, Query Builder, protocol-based assessment, etc.). It is designed to support searches for a specific analysis. 

Alternatively, the Drug Studies table groups together related analyses that FDA conducted to address a safety concern, or set of related safety concerns. The Drug Studies page also provides important background information and describes the regulatory impact.

Note: The appearance of a drug in a Sentinel study does not mean that FDA has concluded that a causal relationship exists between the drug and the health outcome of interest. Patients and healthcare providers should refer to FDA.gov for further information about drug safety.

FDA Sentinel Analyses from ARIA and Other Sentinel Data Sources

Title Medical Product Outcomes Date
Incidence of Hospitalized Tachyarrhythmia in Patients with Type 2 Diabetes Mellitus Using Tirzepatide or Other Long-Acting Glucagon-Like Peptide-1 (GLP-1) Receptor Agonists: A Descriptive Analysis
Descriptive
tirzepatide mounjaro
Characteristics and Rates of Diabetic Ketoacidosis (DKA) by Chronic Kidney Disease (CKD) Stage Among Patients with Short/Rapid-Acting Insulin Use and Type 1 Diabetes Mellitus (T1DM): A Descriptive Analysis
Descriptive
short/​rapid-acting insulin
diabetic ketoacidosis
Characteristics and Rates of Diabetic Ketoacidosis (DKA) Among Users of Sodium-Glucose Co-Transporter 2 (SGLT-2) Inhibitors, Sitagliptin, or Short/Rapid-Acting Insulin: A Descriptive Analysis
Descriptive
short/​rapid-acting insulin,
sitagliptin,
sodium-glucose co-transporter-2 (SGLT-2) inhibitors
diabetic ketoacidosis
Characterization of Patients with Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) and Thrombotic Microangiopathy (TMA) Associated with HSCT (HSCT-TMA) in TriNetX: A Descriptive Analysis
TriNetX Analysis
hematopoietic stem cell transplantation
thrombotic microangiopathy
Trends in Healthcare Encounters Involving Disorders or Poisoning Related to Cannabis, Stratified by the Legality Status of Cannabis by State and Territory: An Updated Descriptive Analysis
Descriptive
cannabis-related disorders
poisoning
Characteristics of Patients with Healthcare Encounters Involving Disorders or Poisoning Related to Cannabis: An Updated Descriptive Analysis
Descriptive
cannabis-related disorders
poisoning
Incidence of Inflammatory Bowel Disease Following Dipeptidyl Peptidase-4 (DPP-4) Inhibitor Use in Patients with Type 2 Diabetes Mellitus: An Inverse Probability of Treatment Weighting Analysis
Retrospective Inferential
dipeptidyl peptidase-4 (DPP-4) inhibitors
inflammatory bowel disease (IBD)
Utilization Patterns of Diabetes Mellitus and Anti-Obesity Drugs: A Descriptive Analysis
Descriptive
Mometasone Furoate Sinus Implant Use in Patients with Nasal Polyps: An Updated Descriptive Analysis
Descriptive
mometasone sinus implant
Characterization of Mothers in the Mother-Infant Linkage Table in the Sentinel Distributed Database: An Updated Descriptive Analysis
Descriptive