Genomics > Table of Pharmacogenomic Biomarkers in Drug Labeling

Genomics > Table of Pharmacogenomic Biomarkers in Drug Labeling

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

Drug	Therapeutic Area	HUGO Symbol	Referenced Subgroup	Labeling 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
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 deficient	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	Dental	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 ultra-rapid metabolizers	Boxed Warnings, Warnings and Precautions, Use in Specific Populations, Clinical Pharmacology , Patient Counseling Information
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 mutation carriers	Indications and Usage, Adverse Reactions, Use in Specific Populations, Clinical Pharmacology, Clinical Studies
Lansoprazole	Gastroenterology	CYP2C19	CYP2C19 poor metabolizers	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	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, 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	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
Obinutuzumab	Oncology	MS4A1	CD20 positive	Indication and Usage, Warnings and Precautions, Description, Clinical Pharmacology, Clinical Studies
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 –ABL T315I	BCR –ABL T315I mutation	Indications and Usage, Adverse Reactions, Clinical Pharmacology, Clinical Studies
Prasugrel	Cardiology	CYP2C19	CYP2C19 poor metabolizers	Use in Specific Populations, Clinical Pharmacology, Clinical Studies
Pravastatin	Endocrinology	LDLR	Homozygous familial hypercholesterolemia	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 familial hypercholesterolemia	Indications and Usage, Dosage and Administration, Clinical Pharmacology, Clinical Studies
Simeprevir	Infectious Diseases	IFNL3	IL28B rs12979860 T allele carriers	Clinical studies, Clinical Pharmacology
Sodium Nitrite	Antidotal Therapy	G6PD	G6PD deficient	Warnings and Precautions
Sofosbuvir	Infectious Diseases	IFNL3	IL28B rs12979860 T allele carriers	Clinical Pharmacology, 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	Indications and Usage, Precautions, Medication Guide
Tamoxifen (2)	Oncology	F5	Factor V Leiden carriers	Warnings
Tamoxifen (3)	Oncology	F2	Prothrombin mutation G20210A positive	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 metabolizers	Dosage and Administration, Precautions, Warnings
Thioridazine	Psychiatry	CYP2D6	CYP2D6 poor metabolizers	Precautions, Warnings, Contraindications
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 (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
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
Vortioxetine	Neurology	CYP2D6	CYP2D6 poor metabolizers	Dosage and Administration, Drug interactions, 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 rs9923231 A allele carriers	Dosage and Administration, Clinical Pharmacology
Warfarin (3)	Cardiology or Hematology	PROC	Protein C deficient	Warning and precautions