Drugs

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. Pharmacogenomic information can appear in different sections of the labeling depending on the actions. For more information, please refer to the appropriate labeling guidance.

Biomarkers in the table include but are not limited to germ-line or somatic gene variants, functional deficiencies, expression changes, and chromosomal abnormalities; selected protein biomarkers that are used to select patients for treatment are also included.

This table does not include non-human genetic biomarkers (e.g., microbial variants that influence sensitivity to antibiotics),; or biomarkers that are used solely for diagnostic purposes (e.g., for genetic diseases) unless they are linked to drug activity or used to identify a specific subset in whom prescribing information differs.

Pharmacogenomic Biomarkers in Drug Labeling

DrugTherapeutic Area*Biomarker†Referenced SubgroupLabeling Sections
Abacavir Infectious Diseases HLA-B HLA-B*5701 allele carriers Boxed Warning, Contraindications, Warnings and Precautions
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)positive Indications and Usage, Dosage and Administration, Adverse Reactions, Clinical Pharmacology, Clinical Studies
Amitriptyline Psychiatry CYP2D6 CYP2D6 poor metabolizers Precautions
Anastrozole Oncology ESR1, PGR Hormone receptor-positive Indications and Usage, Adverse Reactions, Drug Interactions, Clinical Studies
Arformoterol (1) Pulmonary UGT1A1 UGT1A1 poor metabolizers Clinical Pharmacology
Arformoterol (2) Pulmonary CYP2D6 CYP2D6 intermediate or poor metabolizers Clinical Pharmacology
Aripiprazole Psychiatry CYP2D6 CYP2D6 poor metabolizers Dosage and Administration, Clinical Pharmacology
Arsenic Trioxide Oncology PML-RARA PML-RARα translocation positive Clinical Pharmacology, Indications and Usage
Atomoxetine Psychiatry CYP2D6 CYP2D6 poor metabolizers Dosage and Administration, Warnings and Precautions, Drug Interactions, Clinical Pharmacology
Azathioprine Rheumatology TPMT TPMT intermediate or poor metabolizers Clinical Pharmacology, Warnings, Precautions Drug Interactions, Adverse Reactions, Dosage and Administration
Boceprevir Infectious Diseases IFNL3 IL28B rs12979860 T allele carriers (C/T and T/T genotype) Clinical Pharmacology
Bosutinib Oncology BCR/ABL1 Philadelphia chromosome positive Indications and Usage Adverse Reactions, Use in Specific Populations, Clinical Studies
Busulfan Oncology BCR-ABL1 Philadelphia 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, Precautions
Carbamazepine (2) Neurology HLA-A HLA-A*3101 allele carriers Warnings
Carglumic Acid Inborn Errors of Metabolism NAGS N-acetylglutamate synthase deficient Indications and Usage, Warnings and Precautions, Use in Specific Populations Clinical Pharmacology Clinical Studies
Carisoprodol Rheumatology CYP2C19 CYP2C19 poor metabolizers Use in Specific Populations, Clinical Pharmacology
Carvedilol Cardiology CYP2D6 CYP2D6 poor metabolizers Drug Interactions, Clinical Pharmacology
Celecoxib Rheumatology CYP2C9 CYP2C9 poor metabolizers Dosage and Administration, Use in Specific Populations, Clinical Pharmacology
Ceritinib Oncology ALK ALK gene rearrangement positive Indications and Usage, Adverse Reactions, Clinical Pharmacology, Clinical Studies
Cetuximab (1) Oncology EGFR EGFR protein expression positive Indications and Usage, Dosage and Administration, Warnings and Precautions, Adverse Reactions, 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 Dental CYP2D6 CYP2D6 poor metabolizers Precautions
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, Adverse Reactions
Citalopram (1) Psychiatry CYP2C19 CYP2C19 poor metabolizers Clinical Pharmacology, Warnings, Dosage and Administration
Citalopram (2) Psychiatry CYP2D6 CYP2D6 poor metabolizers Clinical Pharmacology
Clobazam Neurology CYP2C19 CYP2C19 poor metabolizers Dosage and Administration, Use in Specific Populations, Clinical Pharmacology
Clomipramine Psychiatry CYP2D6 CYP2D6 poor metabolizers Precautions
Clopidogrel Cardiology CYP2C19 CYP2C19 intermediate or poor metabolizers Boxed Warning, Dosage and Administration, Warnings and Precautions, Clinical Pharmacology
Clozapine Psychiatry CYP2D6 CYP2D6 poor metabolizers Dosage and Administration, Use in Specific Populations, Clinical Pharmacology
Codeine Anesthesiology CYP2D6 CYP2D6 ultra-rapid metabolizers Boxed Warnings, Warnings and Precautions, Use in Specific Populations, Patient Counseling Information
Crizotinib Oncology ALK ALK gene rearrangement positive Indications and Usage, Dosage and Administration, Adverse Reactions, Clinical Pharmacology, Clinical Studies
Dabrafenib (1) Oncology BRAF BRAF V600E/K mutation positive Indications and Usage, Dosage and Administration, Warnings and Precautions, Adverse Reactions, 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 Warnings and Precautions, Use in Specific Populations, Patient Counseling Information
Dapsone (2) Infectious Diseases G6PD G6PD deficient Precautions, Adverse Reactions, Overdosage
Dasatinib Oncology BCR/ABL1 Philadelphia chromosome positive;, T315I mutation-positive Indications and Usage, Dosage and Administration, Warnings and Precautions, Adverse Reactions, Clinical Pharmacology, Clinical Studies
Denileukin Diftitox Oncology IL2RA CD25 antigen positive Indications and Usage, Warnings and Precautions, Clinical Studies
Desipramine Psychiatry CYP2D6 CYP2D6 poor metabolizers Precautions
Dexlansoprazole Gastroenterology CYP2C19 CYP2C19 poor metabolizers Drug Interactions, Clinical Pharmacology
Dextromethorphan and Quinidine Neurology CYP2D6 CYP2D6 poor metabolizers Warnings and Precautions, Clinical Pharmacology
Diazepam Psychiatry CYP2C19 CYP2C19 poor metabolizers Clinical Pharmacology
Divalproex Neurology POLG POLG mutation positive Boxed Warning, Contraindications, Warnings and Precautions
Doxepin (1) Psychiatry CYP2D6 CYP2D6 poor metabolizers Clinical Pharmacology
Doxepin (2) Psychiatry CYP2C19 CYP2D6 poor metabolizers Clinical Pharmacology
Drospirenone and Ethinyl Estradiol Gynecology, Dermatology CYP2C19 CYP2C19 intermediate metabolizers Clinical Pharmacology
Eliglustat Inborn Errors of Metabolism CYP2D6 CYP2D6 ultrarapid, intermediate or poor metabolizers Indications and Usage, Dosage and Administration, Contraindications, Warnings and Precautions, Drug Interactions, Use in Specific Populations, Clinical Pharmacology, Clinical Studies
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 Studies
Erlotinib (2) Oncology EGFR EGFR exon 19 deletion or exon 21 substitution (L858R) positive Indications and Usage Dosage and Administration, Adverse Reactions, 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, Dosage and Administration, Warnings and Precautions, Adverse Reactions, Drug Interactions, Use in Specific Populations, Clinical Pharmacology, Clinical Studies
Everolimus (2) Oncology ESR1 Estrogen receptor positive Clinical Studies
Exemestane (1) Oncology ESR1 Estrogen receptor positive Indications and Usage, Dosage and Administration, Clinical Studies
Exemestane (2) Oncology PGR Progesterone receptor positive Clinical Studies
Fluorouracil (1) Dermatology DPYD DPD deficient Contraindications, Warnings, Patient Information
Fluorouracil (2) Oncology DPYD DPD deficient Warnings
Fluoxetine Psychiatry CYP2D6 CYP2D6 poor metabolizers Clinical Pharmacology, Warnings, Precautions
Flurbiprofen Rheumatology CYP2C9 CYP2C9 poor metabolizers Clinical Pharmacology
Fluvoxamine Psychiatry CYP2D6 CYP2D6 poor metabolizers Drug Interactions
Fulvestrant Oncology ESR1, PGR Hormone receptor positive Indications and Usage, Clinical Pharmacology, Clinical Studies
Galantamine Neurology CYP2D6 CYP2D6 poor metabolizers Clinical Pharmacology
Glimepiride Endocrinology G6PD G6PD deficient Warning and Precautions, Adverse Reactions
Glipizide Endocrinology G6PD G6PD deficient Precautions
Glyburide Endocrinology G6PD G6PD deficient Precautions
Ibrutinib Oncology del (17p) Chromosome 17p deletion positive Indications and Usage, Clinical Studies
Iloperidone Psychiatry CYP2D6 CYP2D6 poor metabolizers Dosage and Administration, Warnings and Precautions,Drug Interactions, Clinical Pharmacology
Imatinib (1) Oncology KIT KIT protein expression positive, c-KIT D816V mutation negative Indications and Usage, Dosage and Administration, Warnings and Precautions, Adverse Reactions, Use in Specific Populations, Clinical Pharmacology, Clinical Studies
Imatinib (2) Oncology BCR-ABL1 Philadelphia chromosome positive Indications and Usage, Dosage and Administration, Warnings and Precautions, Adverse Reactions, Use in Specific Populations, 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 Precautions
Indacaterol Pulmonary UGT1A1 UGT1A1-*28 allele homozygotes Clinical Pharmacology
Irinotecan Oncology UGT1A1 UGT1A1*28 allele carriers Dosage and Administration, Warnings and Precautions, 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 mutation carriers, F508del mutation homozygotes Indications and Usage, Adverse Reactions, Use in Specific Populations, Clinical Pharmacology, Clinical Studies
Lansoprazole Gastroenterology CYP2C19 CYP2C19 intermediate or poor metabolizers Drug Interactions
Lapatinib (1) Oncology ERBB2 HER2 protein overexpression positive Indications and Usage, Dosage and Administration, Adverse Reactions, Use in Specific Populations, Clinical Pharmacology, Clinical Studies
Lapatinib (2) Oncology HLA-DQA1, HLA-DRB1 HLA-DQA1*0201 or -DRB1*0701 allele carriers Clinical Pharmacology
Lenalidomide Hematology del (5q) Chromosome 5q deletion positive Boxed Warning, Indications and Usage, Adverse Reactions, Use in Specific Populations, Clinical Studies
Letrozole Oncology ESR1, PGR Hormone receptor positive Indications and Usage, Adverse Reactions, Clinical Pharmacology, Clinical Studies
Lomitapide Endocrinology LDLR LDLR mutation homozygotes (homozygous familial hypercholesterolemia) Indication and Usage, Warnings and Precautions, Adverse Reactions, Clinical Studies
Mafenide Infectious Diseases G6PD G6PD deficient Warnings, Adverse Reactions
Mercaptopurine Oncology TPMT TPMT intermediate or poor metabolizers Clinical Pharmacology, Warnings, Precautions, Adverse Reactions, Dosage and Administration
Methylene Blue Hematology G6PD G6PD deficient Precautions
Metoclopramide Gastroentrology CYB5R1-4 NADH cytochrome b5 reductase deficient Precautions
Metoprolol Cardiology CYP2D6 CYP2D6 poor metabolizers Clinical Pharmacology
Mipomersen Endocrinology LDLR LDLR mutation heterozygotes and homozygotes (heterozygous and homozygous familial hypercholesterolemia) Boxed Warning, Indications and Usage, Warnings and Precautions, Adverse Reactions, Use in Specific Populations, Clinical Studies
Modafinil Psychiatry CYP2D6 CYP2D6 poor metabolizers Clinical Pharmacology, Precautions
Mycophenolic Acid Transplantation HPRT1 HGPRT deficient Warnings and Precautions
Nalidixic Acid Infectious Diseases G6PD G6PD deficient Precautions, Adverse Reactions
Nefazodone Psychiatry CYP2D6 CYP2D6 poor metabolizers Precautions
Nilotinib (1) Oncology BCR-ABL Philadelphia chromosome positive Indications and Usage, Dosage and Administration, Adverse Reactions, Use in Specififc Populations, Clinical Pharmacology, Clinical Studies
Nilotinib (2) Oncology UGT1A1 UGT1A1*28 allele homozygotes Clinical Pharmacology
Nitrofurantoin Infectious Diseases G6PD G6PD deficient Warnings, Adverse Reactions
Nortriptyline Psychiatry CYP2D6 CYP2D6 poor metabolizers Precautions
Obinutuzumab Oncology MS4A1 CD20 antigen positive Clinical Studies
Omacetaxine Oncology BCR-ABL1 Philadelphia chromosome positive Clinical Pharmacology, Clinical Studies
Omeprazole Gastroenterology CYP2C19 CYP2C19 poor metabolizers Drug Interactions
Panitumumab (1) Oncology EGFR EGFR protein expression positive Clinical Pharmacology, Clinical Studies
Panitumumab (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
Pantoprazole Gastroenterology CYP2C19 CYP2C19 poor metabolizers Clinical Pharmacology
Paroxetine Psychiatry CYP2D6 CYP2D6 extensive metabolizers Drug Interactions
Pazopanib Oncology UGT1A1 UGT1A1*28 allele homozygotes (TA)7/(TA)7 genotype 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
Pegloticase Rheumatology G6PD G6PD deficient Contraindications, Patient Counseling Information
Perphenazine Psychiatry CYP2D6 CYP2D6 poor metabolizers Clinical Pharmacology, Precautions
Pertuzumab Oncology ERBB2 HER2 protein overexpression positive Indications and Usage, Warnings and Precautions, Adverse Reactions, Clinical Pharmacology, Clinical Studies
Phenytoin Neurology HLA-B HLA-B*1502 allele carriers Warnings
Pimozide Psychiatry CYP2D6 CYP2D6 poor metabolizers Precautions, Dosage and Administration
Ponatinib Oncology BCR-ABL1 Philadelphia chromosome positive; T315I mutation positive Indications and Usage, Warnings and Precautions, Adverse Reactions, Use in Specific Populations, Clinical Pharmacology, Clinical Studies
Prasugrel (1) Cardiology CYP2C19 CYP2C19 poor metabolizers Use in Specific Populations, Clinical Pharmacology, Clinical Studies
Prasugrel (2) Cardiology CYP2C9 CYP2C9 variant carriers Use in Specific Populations, Clinical Pharmacology, Clinical Studies
Prasugrel (3) Cardiology CYP3A5 CYP3A5 variant carriers Use in Specific Populations, Clinical Pharmacology, Clinical Studies
Prasugrel (4) Cardiology CYP2B6 CYP2B6 variant carriers Use in Specific Populations, Clinical Pharmacology, Clinical Studies
Pravastatin Endocrinology LDLR LDLR mutation heterozygotes and homozygotes (heterozygous and homozygous familial hypercholesterolemia) Indications and Usage, Use in Specific Populations, Clinical Studies
Primaquine Infectious Diseases G6PD G6PD deficient Warnings and Precautions, Adverse Reactions
Propafenone Cardiology CYP2D6 CYP2D6 poor metabolizers Dosage and Administration, Warnings and Precautions, Clinical Pharmacology
Propranolol Cardiology CYP2D6 CYP2D6 poor metabolizers Clinical Pharmacology
Protriptyline Psychiatry CYP2D6 CYP2D6 poor metabolizers Precautions
Quinidine Cardiology CYP2D6 CYP2D6 poor metabolizers Precautions
Quinine Sulfate (1) Infectious Diseases G6PD G6PD deficient Contraindications
Quinine Sulfate (2) Infectious Diseases CYP2D6 CYP2D6 poor metabolizers Drug Interactions
Rabeprazole Gastroenterology CYP2C19 CYP2C19 poor metabolizers Drug Interactions, Clinical Pharmacology
Rasburicase (1) Oncology G6PD G6PD deficient Boxed Warning, Contraindications, Warnings and Precautions
Rasburicase (2) Oncology CYB5R1-4 NADH cytochrome b5 reductase deficient Warnings and Precautions
Rifampin, Isoniazid, and Pyrazinamide Infectious Diseases NAT1-2 Slow acetylators (inactivators) Clinical Pharmacology, Adverse Reactions
Risperidone Psychiatry CYP2D6 CYP2D6 poor metabolizers Clinical Pharmacology
Rituximab Oncology MS4A1 CD20 antigen positive Indications and Usage, Dosage and Administration, Adverse Reactions, Use in Specific Populations, Clinical Pharmacology, Clinical Studies
Simeprevir Infectious Diseases IFNL3 IL28B rs12979860 T allele carriers Clinical Pharmacology, Clinical Studies
Sodium Nitrite Toxicology G6PD G6PD deficient Warnings and Precautions
Sodium phenylacetate and Sodium Benzoate Inborn Errors of Metabolism NAGS, CPS1, ASS1, OTC, ASL, ABL2 Urea cycle enzyme deficient Indications and Usage, Dosage and Administration, Warnings and Precautions, Adverse Reactions, Drug Interactions, Use in Specific Populations, Overdosage, Clinical Pharmacology, Clinical Studies
Sofosbuvir Infectious Diseases IFNL3 IL28B rs12979860 T allele carriers (non-C/C genotype)IL28B Clinical Studies
Succimer Hematology G6PD G6PD deficient Clinical Pharmacology
Sulfamethoxazole and Trimethoprim Infectious Diseases G6PD G6PD deficient Precautions
Tamoxifen (1) Oncology ESR1, PGR Hormone receptor positive Clinical Pharmacology, Indications and Usage, Precautions, Adverse Reactions, Medication Guide
Tamoxifen (2) Oncology F5 Factor V Leiden carriers Warnings
Tamoxifen (3) Oncology F2 Prothrombin 20210A allele positive Warnings
Telaprevir Infectious Diseases IFNL3 IL28B rs12979860 T allele carriers (C/T and T/T genotype) Clinical Pharmacology, Clinical Studies
Terbinafine Infectious Diseases CYP2D6 CYP2D6 poor metabolizers Drug Interactions
Tetrabenazine Neurology CYP2D6 CYP2D6 poor metabolizers Dosage and Administration, Warnings and Precautions, Use in Specific Populations, Clinical Pharmacology
Thioguanine Oncology TPMT TPMT intermediate or poor metabolizers (deficient) Warnings, Precautions, Dosage and Administration
Thioridazine Psychiatry CYP2D6 CYP2D6 poor metabolizers Contraindications, Warnings, Precautions
Ticagrelor Cardiology CYP2C19 CYP2C19 poor metabolizers Clinical Studies
Tolterodine Genitourinary CYP2D6 CYP2D6 poor metabolizers Warnings and Precautions, Drug Interactions, Use in Specific Populations, Clinical Pharmacology
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 translocation positive Clinical Pharmacology, Indications and Usage, Warnings
Trimipramine Psychiatry CYP2D6 CYP2D6 poor metabolizers Precautions
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
Vemurafenib Oncology BRAF BRAF V600E mutation positive Indications and Usage, Dosage and Administration, Warning and Precautions, Clinical Pharmacology, Clinical Studies, Patient Counseling Information
Venlafaxine Psychiatry CYP2D6 CYP2D6 poor metabolizers Precautions
Voriconazole Infectious Diseases CYP2C19 CYP2C19 intermediate or poor metabolizers Clinical Pharmacology
Vortioxetine Neurology CYP2D6 CYP2D6 poor metabolizers Dosage and Administration, Clinical Pharmacology
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 A allele carriers Dosage and Administration, Clinical Pharmacology
Warfarin (3) Cardiology, Hematology PROS Protein S deficient Warnings and Precautions
Warfarin (4) Cardiology, Hematology PROC Protein C deficient Warnings and Precautions

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