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Table of Pharmacogenomic Biomarkers in Drug Labeling

Pharmacogenomics can play an important role in identifying responders and non-responders to medications, avoiding adverse events, and optimizing drug dose. Drug labeling 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 labeling. The labeling for some, but not all, of the products includes specific actions to be taken based on the biomarker information. Biomarkers in the table include are not limited to germline or somatic gene variants, functional deficiencies, expression changes, and chromosomal abnormalities.

This table does not include non-human genetic biomarkers (e.g., viral or bacterial) i.e., microbial variants that influence sensitivity to anti-invectives; biomarkers that are used solely for diagnostic purposes unless they are linked to drug activity or used to identify a specific subset in whom prescribing information differs (e.g., for genetic diseases). Therapeutic areas do not necessarily reflect the FDA review division.

Pharmacogenomic information can appear in different sections of the labeling. Relevant sections of the labeling with such information are noted in the last column of the table. For more information on the relevance of information in various parts of drug labeling (e.g. Indications and Usage, Dosage and Administration, Boxed Warning, etc.), please refer to the appropriate labeling guidance. For information on the FDA's initiative to improve prescription drug labeling, visit the FDA/CDER Learn website.

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Pharmacogenomic Biomarkers in Drug Labeling

    DrugTherapeutic AreaHUGO SymbolReferenced SubgroupLabeling Sections
    Abacavir Infectious Diseases HLA-B HLA-B*5701 allele carriers Boxed Warning, Contraindications, Warnings and Precautions, Patient Counseling Information
    Ado-Trastuzumab Emtansine Oncology ERBB2 HER2 protein overexpression or gene amplification positive Indications and Usage, Warnings and Precautions, Adverse Reactions, Clinical Pharmacology, Clinical Studies
    Afatinib Oncology EGFR EGFR exon 19 deletion or exon 21 substitution (L858R) mutation positive Indications and Usage, Dosage and Administration, Adverse Reactions, Clinical Pharmacology, Clinical Studies, Patient Counseling Information
    Amitriptyline Psychiatry CYP2D6 CYP2D6 poor metabolizers Precautions
    Anastrozole Oncology ESR1, PGR Hormone receptor positive Indications and Usage, Clinical Pharmacology, Clinical Studies
    Aripiprazole Psychiatry CYP2D6 CYP2D6 poor metabolizers Clinical Pharmacology, Dosage and Administration
    Arsenic Trioxide Oncology PML/RARA PML/RARα (t(15;17)) gene expression positive Boxed Warning, Clinical Pharmacology, Indications and Usage, Warnings
    Atomoxetine Psychiatry CYP2D6 CYP2D6 poor metabolizers Dosage and Administration, Warnings and Precautions, Drug Interactions, Clinical Pharmacology
    Atorvastatin Endocrinology LDLR Homozygous familial hypercholesterolemia Indications and Usage, Dosage and Administration, Warnings and Precautions, Clinical Pharmacology, Clinical Studies
    Azathioprine Rheumatology TPMT TPMT intermediate or poor metabolizers Dosage and Administration, Warnings and Precautions, Drug Interactions, Adverse Reactions, Clinical Pharmacology
    Belimumab Autoimmune Diseases BAFF/TNFSF13B CD257 positive Clinical Pharmacology, Clinical Studies
    Boceprevir Infectious Diseases IFNL3 IL28B rs12979860 T allele carriers Clinical Pharmacology
    Bosutinib Oncology BCR/ABL1 Philadelphia chromosome (t(9;22)) positive Indications and Usage, Adverse Reactions, Clinical Studies
    Brentuximab Vedotin Oncology TNFRSF8 CD30 positive Indications and Usage, Description, Clinical Pharmacology
    Busulfan Oncology Ph Chromosome Ph Chromosome negative Clinical Studies
    Capecitabine Oncology DPYD DPD deficient Contraindications, Warnings and Precautions, Patient Information
    Carbamazepine (1) Neurology HLA-B HLA-B*1502 allele carriers Boxed Warning, Warnings and Precautions
    Carbamazepine (2) Neurology HLA-A HLA-A*3101 allele carriers Boxed Warning, Warnings and Precautions
    Carglumic Acid Metabolic Disorders NAGS N-acetylglutamate synthase deficiency Indications and Usage, Warnings and Precautions, Special Populations, Clinical Pharmacology, Clinical Studies
    Carisoprodol Rheumatology CYP2C19 CYP2C19 poor metabolizers Clinical Pharmacology, Special Populations
    Carvedilol Cardiology CYP2D6 CYP2D6 poor metabolizers Drug Interactions, Clinical Pharmacology
    Celecoxib Rheumatology CYP2C9 CYP2C9 poor metabolizers Dosage and Administration, Drug Interactions, Use in Specific Populations, Clinical Pharmacology
    Cetuximab (1) Oncology EGFR EGFR protein expression positive Indications and Usage, Warnings and Precautions, Description, Clinical Pharmacology, Clinical Studies
    Cetuximab (2) Oncology KRAS KRAS codon 12 and 13 mutation negative Indications and Usage, Dosage and Administration, Warnings and Precautions, Adverse Reactions, Clinical Pharmacology, Clinical Studies
    Cevimeline Dermatology CYP2D6 CYP2D6 poor metabolizers Drug Interactions
    Chloroquine Infectious Diseases G6PD G6PD deficient Precautions
    Chlorpropamide Endocrinology G6PD G6PD deficient Precautions
    Cisplatin Oncology TPMT TPMT intermediate or poor metabolizers Clinical Pharmacology, Warnings, Precautions
    Citalopram (1) Psychiatry CYP2C19 CYP2C19 poor metabolizers Drug Interactions, Warnings
    Citalopram (2) Psychiatry CYP2D6 CYP2D6 poor metabolizers Drug Interactions
    Clobazam Neurology CYP2C19 CYP2C19 poor metabolizers Clinical Pharmacology, Dosage and Administration, Use in Specific Populations
    Clomipramine Psychiatry CYP2D6 CYP2D6 poor metabolizers Drug Interactions
    Clopidogrel Cardiology CYP2C19 CYP2C19 intermediate or poor metabolizers Boxed Warning, Dosage and Administration, Warnings and Precautions, Drug Interactions, Clinical Pharmacology
    Clozapine Psychiatry CYP2D6 CYP2D6 poor metabolizers Drug Interactions, Clinical Pharmacology
    Codeine Anesthesiology CYP2D6 CYP2D6 poor metabolizers Warnings and Precautions, Use in Specific Populations, Clinical Pharmacology
    Crizotinib Oncology ALK ALK gene rearrangement positive Indications and Usage, Dosage and Administration, Drug Interactions, Warnings and Precautions, Adverse Reactions, Clinical Pharmacology, Clinical Studies
    Dabrafenib (1) Oncology BRAF BRAF V600E mutation positive Indications and Usage, Dosage and Administration, Warnings and Precautions, Clinical Pharmacology, Clinical Studies, Patient Counseling Information
    Dabrafenib (2) Oncology G6PD G6PD deficient Warnings and Precautions, Adverse Reactions, Patient Counseling Information
    Dapsone (1) Dermatology G6PD G6PD deficient Indications and Usage, Precautions, Adverse Reactions, Patient Counseling Information
    Dapsone (2) Infectious Diseases G6PD G6PD deficient Precautions, Adverse Reactions, Overdosage
    Dasatinib Oncology BCR/ABL1 Philadelphia chromosome (t(9;22)) positive; T315I mutation-positive Indications and Usage, Clinical Studies, Patient Counseling Information
    Denileukin Diftitox Oncology IL2RA CD25 antigen positive Indications and Usage, Warnings and Precautions, Clinical Studies
    Desipramine Psychiatry CYP2D6 CYP2D6 poor metabolizers Drug Interactions
    Dexlansoprazole (1) Gastroenterology CYP2C19 CYP2C19 poor metabolizers Clinical Pharmacology, Drug Interactions
    Dexlansoprazole (2) Gastroenterology CYP1A2 CYP1A2 genotypes Clinical Pharmacology
    Dextromethorphan and Quinidine Neurology CYP2D6 CYP2D6 poor metabolizers Clinical Pharmacology, Warnings and Precautions, Drug Interactions
    Diazepam Psychiatry CYP2C19 CYP2C19 poor metabolizers Drug Interactions, Clinical Pharmacology
    Doxepin Psychiatry CYP2D6 CYP2D6 poor metabolizers Precautions
    Drospirenone and Ethinyl Estradiol Neurology CYP2C19 CYP2C19 poor metabolizers Clinical Pharmacology, Warnings and Precautions, Drug Interactions
    Eltrombopag (1) Hematology F5 Factor V Leiden carriers Warnings and Precautions
    Eltrombopag (2) Hematology SERPINC1 Antithrombin III deficient Warnings and Precautions
    Erlotinib (1) Oncology EGFR EGFR protein expression positive Clinical Pharmacology
    Erlotinib (2) Oncology EGFR EGFR exon 19 deletion or exon 21 substitution (L858R) positive Indications and Usage, Dosage and Administration, Clinical Pharmacology, Clinical Studies
    Esomeprazole Gastroenterology CYP2C19 CYP2C19 poor metabolizers Drug Interactions, Clinical Pharmacology
    Everolimus (1) Oncology ERBB2 HER2 protein overexpression negative Indications and Usage, Boxed Warning, Adverse Reactions, Use in Specific Populations, Clinical Pharmacology, Clinical Studies
    Everolimus (2) Oncology ESR1 Estrogen receptor positive Clinical Pharmacology, Clinical Studies
    Exemestane Oncology ESR1 Estrogen receptor positive Indications and Usage, Dosage and Administration, Clinical Studies, Clinical Pharmacology
    Fluorouracil (1) Dermatology DPYD DPD deficient Contraindications, Warnings, Patient Information
    Fluorouracil (2) Oncology DPYD DPD deficient Warnings
    Fluoxetine Psychiatry CYP2D6 CYP2D6 poor metabolizers Warnings, Precautions, Clinical Pharmacology
    Flurbiprofen Rheumatology CYP2C9 CYP2C9 poor metabolizers Clinical Pharmacology, Special Populations
    Fluvoxamine Psychiatry CYP2D6 CYP2D6 poor metabolizers Drug Interactions
    Fulvestrant Oncology ESR1 Estrogen receptor positive Indications and Usage, Clinical Pharmacology, Clinical Studies, Patient Counseling Information
    Galantamine Neurology CYP2D6 CYP2D6 poor metabolizers Special Populations
    Glimepiride Endocrinology G6PD G6PD deficient Warning and Precautions
    Glipizide Endocrinology G6PD G6PD deficient Precautions
    Glyburide Endocrinology G6PD G6PD deficient Precautions
    Ibritumomab Tiuxetan Oncology MS4A1 CD20 positive Indications and Usage, Clinical Pharmacology, Description
    Iloperidone Psychiatry CYP2D6 CYP2D6 poor metabolizers Clinical Pharmacology, Dosage and Administration, Drug Interactions, Specific Populations, Warnings and Precautions
    Imatinib (1) Oncology KIT c-KIT D816V mutation negative Indications and Usage, Dosage and Administration Clinical Pharmacology, Clinical Studies
    Imatinib (2) Oncology BCR/ABL1 Philadelphia chromosome (t(9;22)) positive Indications and Usage, Dosage and Administration, Clinical Pharmacology, Clinical Studies
    Imatinib (3) Oncology PDGFRB PDGFR gene rearrangement positive Indications and Usage, Dosage and Administration, Clincal Studies
    Imatinib (4) Oncology FIP1L1/PDGFRA FIP1L1/PDGFRα fusion kinase (or CHIC2 deletion) positive Indications and Usage, Dosage and Administration, Clinical Studies
    Imipramine Psychiatry CYP2D6 CYP2D6 poor metabolizers Drug Interactions
    Indacaterol Pulmonary UGT1A1 UGT1A1 *28 allele homozygotes Clinical Pharmacology
    Irinotecan Oncology UGT1A1 UGT1A1*28 allele carriers Dosage and Administration, Warnings, Clinical Pharmacology
    Isosorbide and Hydralazine Cardiology NAT1-2 Slow acetylators Clinical Pharmacology
    Ivacaftor Pulmonary CFTR CFTR G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N, or S549R carriers Indications and Usage, Adverse Reactions, Use in Specific Populations, Clinical Pharmacology, Clinical Studies
    Lansoprazole Gastroenterology CYP2C19 CYP2C19 poor metabolizer Drug Interactions, Clinical Pharmacology
    Lapatinib Oncology ERBB2 HER2 protein overexpression positive Indications and Usage, Clinical Pharmacology, Patient Counseling Information
    Lenalidomide Hematology del (5q) Chromosome 5q deletion Boxed Warning, Indications and Usage, Clinical Studies, Patient Counseling
    Letrozole Oncology ESR1, PGR Hormone receptor positive Indications and Usage, Adverse Reactions, Clinical Studies, Clinical Pharmacology
    Lomitapide Endocrinology LDLR Homozygous familial hypercholesterolemia and LDL receptor mutation deficient Indication and Usage, Adverse Reactions, Clinical Studies
    Mafenide Infectious Diseases G6PD G6PD deficient Warnings, Adverse Reactions
    Maraviroc Infectious Diseases CCR5 CCR5 positive Indications and Usage, Warnings and Precautions, Clinical Pharmacology, Clinical Studies, Patient Counseling Information
    Mercaptopurine Oncology TPMT TPMT intermediate or poor metabolizers Dosage and Administration, Contraindications, Precautions, Adverse Reactions, Clinical Pharmacology
    Methylene Blue Hematology G6PD G6PD deficient Precautions
    Metoclopramide Gastroentrology CYB5R1-4 NADH cytochrome b5 reductase deficient Precautions
    Metoprolol Cardiology CYP2D6 CYP2D6 poor metabolizers Precautions, Clinical Pharmacology
    Mipomersen Endocrinology LDLR Homozygous familial hypercholesterolemia and LDL receptor mutation deficient Indication and Usage, Clinical Studies, Use in Specific Populations
    Modafinil Psychiatry CYP2D6 CYP2D6 poor metabolizers Drug Interactions
    Mycophenolic Acid Transplantation HPRT1 HGPRT deficient Precautions
    Nalidixic Acid Infectious Diseases G6PD G6PD deficient Precautions, Adverse Reactions
    Nefazodone Psychiatry CYP2D6 CYP2D6 poor metabolizers Drug Interactions
    Nilotinib (1) Oncology BCR/ABL1 Philadelphia chromosome (t(9 :22)) positive Indications and Usage, Patient Counseling Information
    Nilotinib (2) Oncology UGT1A1 UGT1A1*28 allele homozygotes Warnings and Precautions, Clinical Pharmacology
    Nitrofurantoin Infectious Diseases G6PD G6PD deficient Warnings, Adverse Reactions
    Nortriptyline Psychiatry CYP2D6 CYP2D6 poor metabolizers Drug Interactions
    Ofatumumab Oncology MS4A1 CD20 positive Indications and Usage, Clinical Pharmacology
    Omacetaxine Oncology BCR/ABL1 BCR-ABL T315I Clinical Pharmacology
    Omeprazole Gastroenterology CYP2C19 CYP2C19 poor metabolizers Dosage and Administration, Warnings and Precautions, Drug Interactions
    Panitumumab (1) Oncology EGFR EGFR protein expression positive Indications and Usage, Warnings and Precautions, Clinical Pharmacology, Clinical Studies
    Panitumumab (2) Oncology KRAS KRAS codon 12 and 13 mutation negative Indications and Usage, Clinical Pharmacology, Clinical Studies
    Pantoprazole Gastroenterology CYP2C19 CYP2C19 poor metabolizers Clinical Pharmacology, Drug Interactions, Special Populations
    Paroxetine Psychiatry CYP2D6 CYP2D6 poor metabolizers Clinical Pharmacology, Drug Interactions
    Pazopanib Oncology UGT1A1 (TA)7/(TA)7 genotype (UGT1A1*28/*28) Clinical Pharmacology, Warnings and Precautions
    PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, and Ascorbic Acid Gastroenterology G6PD G6PD deficient Warnings and Precautions
    Peginterferon alfa-2b Infectious Diseases IFNL3 IL28B rs12979860 T allele carriers Clinical Pharmacology
    Pegloticase Rheumatology G6PD G6PD deficient Contraindications, Patient Counseling Information
    Perphenazine Psychiatry CYP2D6 CYP2D6 poor metabolizers Clinical Pharmacology, Drug Interactions
    Pertuzumab Oncology ERBB2 HER2 protein overexpression positive Indications and Usage, Warnings and Precautions, Adverse Reactions, Clinical Studies, Clinical Pharmacology
    Phenytoin Neurology HLA-B HLA-B*1502 allele carriers Warnings
    Pimozide Psychiatry CYP2D6 CYP2D6 poor metabolizers Warnings, Precautions, Contraindications, Dosage and Administration
    Ponatinib Oncology BCR/ABL1 Philadelphia chromosome (t(9;22)) positive, BCR –ABL T315I mutation Indications and Usage, Warnings and Precautions, Adverse Reactions, Use in Specific Populations, Clinical Pharmacology, Clinical Studies
    Prasugrel Cardiology CYP2C19 CYP2C19 poor metabolizers Use in Specific Populations, Clinical Pharmacology, Clinical Studies
    Pravastatin Endocrinology LDLR Homozygous familial hypercholesterolemia and LDL receptor deficient Clinical Studies, Use in Specific Populations
    Primaquine Infectious Diseases G6PD G6PD deficient Warnings and Precautions, Adverse Reactions
    Propafenone Cardiology CYP2D6 CYP2D6 poor metabolizers Clinical Pharmacology
    Propranolol Cardiology CYP2D6 CYP2D6 poor metabolizers Precautions, Drug Interactions, Clinical Pharmacology
    Protriptyline Psychiatry CYP2D6 CYP2D6 poor metabolizers Precautions
    Quinidine Cardiology CYP2D6 CYP2D6 poor metabolizers Precautions
    Quinine Sulfate Infectious Diseases G6PD G6PD deficient Contraindications, Patient Counseling Information
    Rabeprazole Gastroenterology CYP2C19 CYP2C19 poor metabolizers Drug Interactions, Clinical Pharmacology
    Rasburicase Oncology G6PD G6PD deficient Boxed Warning, Contraindications
    Rifampin, Isoniazid, and Pyrazinamide Infectious Diseases NAT1-2 Slow inactivators Adverse Reactions, Clinical Pharmacology
    Risperidone Psychiatry CYP2D6 CYP2D6 poor metabolizers Drug Interactions, Clinical Pharmacology
    Rituximab Oncology MS4A1 CD20 positive Indication and Usage, Clinical Pharmacology, Description, Precautions
    Rosuvastatin Endocrinology LDLR Homozygous and Heterozygous familial hypercholesterolemia Indications and Usage, Dosage and Administration, Clinical Pharmacology, Clinical Studies
    Sodium Nitrite Antidotal Therapy G6PD G6PD deficient Warnings and Precautions
    Succimer Hematology G6PD G6PD deficient Clinical Pharmacology
    Sulfamethoxazole and Trimethoprim Infectious Diseases G6PD G6PD deficient Precautions
    Tamoxifen (1) Oncology ESR1, PGR Hormone receptor positive Indications and Usage, Precautions, Medication Guide
    Tamoxifen (2) Oncology F5 Factor V Leiden carriers Warnings
    Tamoxifen (3) Oncology F2 Prothrombin mutation G20210A Warnings
    Telaprevir Infectious Diseases IFNL3 IL28B rs12979860 T allele carriers Clinical Pharmacology
    Terbinafine Infectious Diseases CYP2D6 CYP2D6 poor metabolizers Drug Interactions
    Tetrabenazine Neurology CYP2D6 CYP2D6 poor metabolizers Dosage and Administration, Warnings, Clinical Pharmacology
    Thioguanine Oncology TPMT TPMT poor metabolizer Dosage and Administration, Precautions, Warnings
    Thioridazine Psychiatry CYP2D6 CYP2D6 poor metabolizers Precautions, Warnings, Contraindications
    Ticagrelor Cardiology CYP2C19 CYP2C19 poor metabolizers Clinical Studies
    Tolterodine Urology CYP2D6 CYP2D6 poor metabolizers Clinical Pharmacology, Drug Interactions, Warnings and Precautions
    Tositumomab Oncology MS4A1 CD20 antigen positive Indications and Usage, Clinical Pharmacology
    Tramadol Analgesic CYP2D6 CYP2D6 poor metabolizers Clinical Pharmacology
    Trametinib Oncology BRAF BRAF V600E/K mutation positive Indications and Usage, Dosage and Administration, Adverse Reactions, Clinical Pharmacology, Clinical Studies, Patient Counseling Information
    Trastuzumab Oncology ERBB2 HER2 protein overexpression positive Indications and Usage, Warnings and Precautions, Clinical Pharmacology, Clinical Studies
    Tretinoin Oncology PML/RARA PML/RARα (t(15;17)) gene expression positive Clinical Studies, Indications and Usage, Warnings
    Trimipramine Psychiatry CYP2D6 CYP2D6 poor metabolizers Drug Interactions
    Valproic Acid (1) Neurology POLG POLG mutation positive Boxed Warning, Contraindications, Warnings and Precautions
    Valproic Acid (2) Neurology NAGS, CPS1, ASS1, OTC, ASL, ABL2 Urea cycle enzyme deficient Contraindications, Warnings and Precautions, Adverse Reactions, Medication Guide
    Velaglucerase Alfa Metabolic Disorders GBA Lysosomal glucocerebrosidase enzyme Indication and Usage, Description, Clinical Pharmacology, Clinical Studies
    Vemurafenib Oncology BRAF BRAF V600E mutation positive Indications and Usage, Warning and Precautions, Clinical Pharmacology, Clinical Studies, Patient Counseling Information
    Venlafaxine Psychiatry CYP2D6 CYP2D6 poor metabolizers Drug Interactions
    Voriconazole Infectious Diseases CYP2C19 CYP219 intermediate or poor metabolizers Clinical Pharmacology, Drug Interactions
    Warfarin (1) Cardiology or Hematology CYP2C9 CYP2C9 intermediate or poor metabolizers Dosage and Administration, Drug Interactions, Clinical Pharmacology
    Warfarin (2) Cardiology or Hematology VKORC1 VKORC1 rs9923231 A allele carriers Dosage and Administration, Clinical Pharmacology
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