Table of Pharmacogenomic Biomarkers in Drug Labels

Pharmacogenomics can play an important role in identifying responders and non-responders to medications, avoiding adverse events, and optimizing drug dose. Drug labels may contain information on genomic biomarkers and can describe:

Drug exposure and clinical response variability
Risk for adverse events
Genotype-specific dosing
Mechanisms of drug action
Polymorphic drug target and disposition genes

The table below lists FDA-approved drugs with pharmacogenomic information in their labels. Relevant sections of the label with such information are noted in the last column of the table. Biomarkers may include gene variants, functional deficiencies, expression changes, chromosomal abnormalities, and others. Please note that the table columns can be sorted.

Pharmacogenomic information can appear in different sections of the label. For more information on the relevance of information in various parts of the drug label (e.g. Indications and Usage, Dosage and Administration, Boxed Warning, etc.), please go to the relevant labeling guidance¹. For information on the FDA's initiative to improve prescription drug labels, please visit the FDA/CDER Learn website².

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