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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
Cardiac Malformations and Oral Clefts Following in Utero Exposure to Cyclobenzaprine: A Propensity Score Stratified Analysis
Retrospective Inferential
cyclobenzaprine
cardiac malformations
oral clefts
Characterization of Metformin Users with Polycystic Ovarian Syndrome: A Descriptive Analysis
Descriptive
metformin
off-label use in polycystic ovarian syndrome
Utilization Patterns of Metformin in Patients with Polycystic Ovarian Syndrome: A Descriptive Analysis
Descriptive
metformin
off-label use in polycystic ovarian syndrome
Frequency of Blood Phosphate Monitoring Following Ferric Carboxymaltose (FCM) Administration in Patients in the Sentinel Distributed Database: A Descriptive Analysis
Descriptive
Mycophenolate Use During Pregnancy: A Descriptive Analysis
Descriptive
mycophenolate
use in pregnancy
Etonogestrel Implant Insertions and Removals Among Females by Provider Specialty in the Sentinel Distributed Database: A Descriptive Analysis
Descriptive
Ketamine Use in Patients with Emergency Department Encounters: A Second Descriptive Analysis
Descriptive
ketamine
Ketamine Use in Patients with Emergency Department Encounters: A Descriptive Analysis
Descriptive
ketamine
Prevalence of Cutaneous Lupus Erythematosus in the Sentinel Distributed Database: A Descriptive Analysis
Descriptive
Dihydropyrimidine Dehydrogenase (DPYD) Gene Variant Testing Rates and Fluoropyrimidine Use Following Pharmacogenetic Testing Among Incident Fluoropyrimidine Users: A Descriptive Analysis
Descriptive