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U.S. Department of Health and Human Services

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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. Some, but not all, of the labels include specific actions to be taken based on genetic information. 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. Microbial variants that influence sensitivity to anti-infectives are not included in the table. 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 guidance. For information on the FDA's initiative to improve prescription drug labels, visit the FDA/CDER Learn website.

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Pharmacogenomic Biomarkers in Drug Labels

    DrugTherapeutic AreaBiomarkerLabel Sections
    Abacavir Antivirals HLA-B*5701 Boxed Warning, Contraindications, Warnings and Precautions, Patient Counseling Information
    Aripiprazole Psychiatry CYP2D6 Clinical Pharmacology, Dosage and Administration
    Arsenic Trioxide Oncology PML/RARα Boxed Warning, Clinical Pharmacology, Indications and Usage, Warnings
    Atomoxetine Psychiatry CYP2D6 Dosage and Administration, Warnings and Precautions, Drug Interactions, Clinical Pharmacology
    Atorvastatin Metabolic and Endocrinology LDL receptor Indications and Usage, Dosage and Administration, Warnings and Precautions, Clinical Pharmacology, Clinical Studies
    Azathioprine Rheumatology TPMT Dosage and Administration, Warnings and Precautions, Drug Interactions, Adverse Reactions, Clinical Pharmacology
    Boceprevir Antivirals IL28B Clinical Pharmacology
    Brentuximab Vedotin Oncology CD30 Indications and Usage, Description, Clinical Pharmacology
    Busulfan Oncology Ph Chromosome Clinical Studies
    Capecitabine Oncology DPD Contraindications, Precautions, Patient Information
    Carbamazepine Neurology HLA-B*1502 Boxed Warning, Warnings and Precautions
    Carisoprodol Musculoskeletal CYP2C19 Clinical Pharmacology, Special Populations
    Carvedilol Cardiovascular CYP2D6 Drug Interactions, Clinical Pharmacology
    Celecoxib Analgesics CYP2C9 Dosage and Administration, Drug Interactions, Use in Specific Populations, Clinical Pharmacology
    Cetuximab (1) Oncology EGFR Indications and Usage, Warnings and Precautions, Description, Clinical Pharmacology, Clinical Studies
    Cetuximab (2) Oncology KRAS Indications and Usage, Dosage and Administration, Warnings and Precautions, Adverse Reactions, Clinical Pharmacology, Clinical Studies
    Cevimeline Dermatology and Dental CYP2D6 Drug Interactions
    Chlordiazepoxide and Amitriptyline Psychiatry CYP2D6 Precautions
    Chloroquine Antiinfectives G6PD Precautions
    Cisplatin Oncology TPMT Clinical Pharmacology, Warnings, Precautions
    Citalopram (1) Psychiatry CYP2C19 Drug Interactions, Warnings
    Citalopram (2) Psychiatry CYP2D6 Drug Interactions
    Clobazam Neurology CYP2C19 Clinical Pharmacology, Dosage and Administration, Use in Specific Populations
    Clomipramine Psychiatry CYP2D6 Drug Interactions
    Clopidogrel Cardiovascular CYP2C19 Boxed Warning, Dosage and Administration, Warnings and Precautions, Drug Interactions, Clinical Pharmacology
    Clozapine Psychiatry CYP2D6 Drug Interactions, Clinical Pharmacology
    Codeine Analgesics CYP2D6 Warnings and Precautions, Use in Specific Populations, Clinical Pharmacology
    Crizotinib Oncology ALK Indications and Usage, Warnings and Precautions, Adverse Reactions, Clinical Pharmacology, Clinical Studies
    Dapsone Dermatology and Dental G6PD Indications and Usage, Precautions, Adverse Reactions, Patient Counseling Information
    Dasatinib Oncology Ph Chromosome Indications and Usage, Clinical Studies, Patient Counseling Information
    Denileukin Diftitox Oncology CD25 Indications and Usage, Warnings and Precautions, Clinical Studies
    Desipramine Psychiatry CYP2D6 Drug Interactions
    Dexlansoprazole (1) Gastroenterology CYP2C19 Clinical Pharmacology, Drug Interactions
    Dexlansoprazole (2) Gastroenterology CYP1A2 Clinical Pharmacology
    Dextromethorphan and Quinidine Neurology CYP2D6 Clinical Pharmacology, Warnings and Precautions
    Diazepam Psychiatry CYP2C19 Drug Interactions, Clinical Pharmacology
    Doxepin Psychiatry CYP2D6 Precautions
    Drospirenone and Ethinyl Estradiol Reproductive CYP2C19 Precautions, Drug Interactions
    Eltrombopag (1) Hematology Factor V Leiden (FV) Warnings and Precautions
    Eltrombopag (2) Hematology Antithrombin III deficiency (SERPINC1) Warnings and Precautions
    Erlotinib Oncology EGFR Clinical Pharmacology
    Esomeprazole Gastroenterology CYP2C19 Drug Interactions, Clinical Pharmacology
    Everolimus Oncology HER2/NEU Indications and Usage, Boxed Warning, Adverse Reactions, Use in Specific Populations, Clinical Pharmacology, Clinical Studies
    Exemestane Oncology ER &/ PGR Indications and Usage, Dosage and Administration, Clinical Studies, Clinical Pharmacology
    Fluorouracil Dermatology and Dental DPD Contraindications, Warnings
    Fluoxetine Psychiatry CYP2D6 Warnings, Precautions, Clinical Pharmacology
    Fluoxetine and Olanzapine Psychiatry CYP2D6 Drug Interactions, Clinical Pharmacology
    Flurbiprofen Rheumatology CYP2C9 Clinical Pharmacology, Special Populations
    Fluvoxamine Psychiatry CYP2D6 Drug Interactions
    Fulvestrant Oncology ER Indications and Usage, Patient Counseling Information
    Galantamine Neurology CYP2D6 Special Populations
    Gefitinib Oncology EGFR Clinical Pharmacology
    Iloperidone Psychiatry CYP2D6 Clinical Pharmacology, Dosage and Administration, Drug Interactions, Specific Populations, Warnings and Precautions
    Imatinib (1) Oncology C-Kit Indications and Usage, Dosage and Administration Clinical Pharmacology, Clinical Studies
    Imatinib (2) Oncology Ph Chromosome Indications and Usage, Dosage and Administration, Clinical Pharmacology, Clinical Studies
    Imatinib (3) Oncology PDGFR Indications and Usage, Dosage and Administration, Clincal Studies
    Imatinib (4) Oncology FIP1L1-PDGFRα Indications and Usage, Dosage and Administration, Clinical Studies
    Imipramine Psychiatry CYP2D6 Drug Interactions
    Indacaterol Pulmonary UGT1A1 Clinical Pharmacology
    Irinotecan Oncology UGT1A1 Dosage and Administration, Warnings, Clinical Pharmacology
    Isosorbide and Hydralazine Cardiovascular NAT1; NAT2 Clinical Pharmacology
    Ivacaftor Pulmonary CFTR (G551D) Indications and Usage, Adverse Reactions, Use in Specific Populations, Clinical Pharmacology, Clinical Studies
    Lansoprazole Gastroenterology CYP2C19 Drug Interactions, Clinical Pharmacology
    Lapatinib Oncology HER2/NEU Indications and Usage, Clinical Pharmacology, Patient Counseling Information
    Lenalidomide Hematology Chromosome 5q Boxed Warning, Indications and Usage, Clinical Studies, Patient Counseling
    Letrozole Oncology ER &/ PGR Indications and Usage, Adverse Reactions, Clinical Studies, Clinical Pharmacology
    Maraviroc Antivirals CCR5 Indications and Usage, Warnings and Precautions, Clinical Pharmacology, Clinical Studies, Patient Counseling Information
    Mercaptopurine Oncology TPMT Dosage and Administration, Contraindications, Precautions, Adverse Reactions, Clinical Pharmacology
    Metoprolol Cardiovascular CYP2D6 Precautions, Clinical Pharmacology
    Modafinil Psychiatry CYP2D6 Drug Interactions
    Mycophenolic Acid Transplantation HGPRT Precautions
    Nefazodone Psychiatry CYP2D6 Drug Interactions
    Nilotinib (1) Oncology Ph Chromosome Indications and Usage, Patient Counseling Information
    Nilotinib (2) Oncology UGT1A1 Warnings and Precautions, Clinical Pharmacology
    Nortriptyline Psychiatry CYP2D6 Drug Interactions
    Omeprazole Gastroenterology CYP2C19 Dosage and Administration, Warnings and Precautions, Drug Interactions
    Panitumumab (1) Oncology EGFR Indications and Usage, Warnings and Precautions, Clinical Pharmacology, Clinical Studies
    Panitumumab (2) Oncology KRAS Indications and Usage, Clinical Pharmacology, Clinical Studies
    Pantoprazole Gastroenterology CYP2C19 Clinical Pharmacology, Drug Interactions, Special Populations
    Paroxetine Psychiatry CYP2D6 Clinical Pharmacology, Drug Interactions
    Peginterferon alfa-2b Antivirals IL28B Clinical Pharmacology
    Perphenazine Psychiatry CYP2D6 Clinical Pharmacology, Drug Interactions
    Pertuzumab Oncology HER2/NEU Indications and Usage, Warnings and Precautions, Adverse Reactions, Clinical Studies, Clinical Pharmacology
    Phenytoin Neurology HLA-B*1502 Warnings
    Pimozide Psychiatry CYP2D6 Warnings, Precautions, Contraindications, Dosage and Administration
    Prasugrel Cardiovascular CYP2C19 Use in Specific Populations, Clinical Pharmacology, Clinical Studies
    Pravastatin Metabolic and Endocrinology APOE2 Clinical Studies, Use in Specific Populations
    Propafenone Cardiovascular CYP2D6 Clinical Pharmacology
    Propranolol Cardiovascular CYP2D6 Precautions, Drug Interactions, Clinical Pharmacology
    Protriptyline Psychiatry CYP2D6 Precautions
    Quinidine Antiarrhythmics CYP2D6 Precautions
    Rabeprazole Gastroenterology CYP2C19 Drug Interactions, Clinical Pharmacology
    Rasburicase Oncology G6PD Boxed Warning, Contraindications
    Rifampin, Isoniazid, and Pyrazinamide Antiinfectives NAT1; NAT2 Adverse Reactions, Clinical Pharmacology
    Risperidone Psychiatry CYP2D6 Drug Interactions, Clinical Pharmacology
    Sodium Phenylacetate and Sodium Benzoate Gastroenterology UCD (NAGS; CPS; ASS; OTC; ASL; ARG) Indications and Usage, Description, Clinical Pharmacology
    Sodium Phenylbutyrate Gastroenterology UCD (NAGS; CPS; ASS; OTC; ASL; ARG) Indications and Usage, Dosage and Administration, Nutritional Management
    Tamoxifen (1) Oncology ER Indications and Usage, Precautions, Medication Guide
    Tamoxifen (2) Oncology Factor V Leiden (FV) Warnings
    Tamoxifen (3) Oncology Prothrombin mutations (F2) Warnings
    Telaprevir Antivirals IL28B Clinical Pharmacology
    Terbinafine Antifungals CYP2D6 Drug Interactions
    Tetrabenazine Neurology CYP2D6 Dosage and Administration, Warnings, Clinical Pharmacology
    Thioguanine Oncology TPMT Dosage and Administration, Precautions, Warnings
    Thioridazine Psychiatry CYP2D6 Precautions, Warnings, Contraindications
    Ticagrelor Cardiovascular CYP2C19 Clinical Studies
    Tolterodine Reproductive and Urologic CYP2D6 Clinical Pharmacology, Drug Interactions, Warnings and Precautions
    Tositumomab Oncology CD20 antigen Indications and Usage, Clinical Pharmacology
    Tramadol and Acetaminophen Analgesics CYP2D6 Clinical Pharmacology
    Trastuzumab Oncology HER2/NEU Indications and Usage, Precautions, Clinical Pharmacology
    Tretinoin Dermatology and Dental PML/RARα Boxed Warning, Dosage and Administration, Precautions
    Trimipramine Psychiatry CYP2D6 Drug Interactions
    Valproic Acid Psychiatry UCD (NAGS; CPS; ASS; OTC; ASL; ARG) Contraindications, Precautions, Adverse Reactions
    Vemurafenib Oncology BRAF Indications and Usage, Warning and Precautions, Clinical Pharmacology, Clinical Studies, Patient Counseling Information
    Venlafaxine Psychiatry CYP2D6 Drug Interactions
    Voriconazole Antifungals CYP2C19 Clinical Pharmacology, Drug Interactions
    Warfarin (1) Hematology CYP2C9 Dosage and Administration, Precautions, Clinical Pharmacology
    Warfarin (2) Hematology VKORC1 Dosage and Administration, Precautions, Clinical Pharmacology
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