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Table of Pharmacogenomic Biomarkers in Drug Labeling

Back to Pharmacogenomics: Overview of the Genomics and Targeted Therapy Group

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
  • Trial design features

The table below lists therapeutic products from Drugs@FDA with pharmacogenomic information found in the drug 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 germline or somatic gene variants (polymorphisms, mutations), functional deficiencies with a genetic etiology, gene expression differences, and chromosomal abnormalities; selected protein biomarkers that are used to select treatments for patients are also included.

This table does not include non-human genetic biomarkers (e.g., microbial variants that influence sensitivity to antibiotics), 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, or biomarkers that are related to a drug other than the referenced drug (e.g., influences the effect of the referenced drug as a perpetrator of an interaction with another drug). For drugs that are available in multiple dosage forms, salts, or combinations, a single representative product is listed. In the case of combination products, the single agent associated with the biomarker is listed unless the agent is only approved as a combination product, in which case all agents are listed.

Download detailed version of the Table of Pharmacogenomic Biomarkers in Drug Labeling with Labeling Text (PDF - 2.20MB)

Pharmacogenomic Biomarkers in Drug Labeling

Drug Therapeutic Area* Biomarker Labeling Sections
Abacavir Infectious Diseases HLA-B Boxed Warning, Dosage and Administration, Contraindications, Warnings and Precautions
Abemaciclib (1) Oncology ESR
(Hormone Receptor)
Indications and Usage, Adverse Reactions, Clinical Studies
Abemaciclib (2) Oncology ERBB2
(HER2)
Indications and Usage, Adverse Reactions, Clinical Studies
Ado-Trastuzumab Emtansine Oncology ERBB2
(HER2)
Indications and Usage, Dosage and Administration, Adverse Reactions, Clinical Pharmacology, Clinical Studies
Afatinib Oncology EGFR Indications and Usage, Dosage and Administration, Adverse Reactions, Clinical Studies
Alectinib Oncology ALK Indications and Usage, Dosage and Administration, Adverse Reactions, Clinical Pharmacology, Clinical Studies
Alpelisib (1)  Oncology ERBB2
(HER2)
Indication and Usage, Dosage and Administration, Adverse Reactions, Clinical Studies
Alpelisib (2) Oncology ESR
(Hormone Receptor)
Indication and Usage, Dosage and Administration, Adverse Reactions, Clinical Studies
Alpelisib (3) Oncology PIK3CA Indication and Usage, Dosage and Administration, Adverse Reactions, Clinical Studies
Amifampridine Neurology NAT2 Dosage and Administration, Adverse Reactions, Use in Specific Populations, Clinical Pharmacology
Amifampridine Phosphate Neurology NAT2 Dosage and Administration, Use in Specific Populations, Clinical Pharmacology
Amitriptyline Psychiatry CYP2D6 Precautions
Amoxapine Psychiatry CYP2D6 Precautions
Amphetamine Psychiatry CYP2D6 Clinical Pharmacology
Anastrozole Oncology ESR, PGR
(Hormone Receptor)
Indications and Usage, Adverse Reactions, Drug Interactions, Clinical Studies
Arformoterol (1) Pulmonary UGT1A1 Clinical Pharmacology
Arformoterol (2) Pulmonary CYP2D6 Clinical Pharmacology
Aripiprazole Psychiatry CYP2D6 Dosage and Administration, Use in Specific Populations, Clinical Pharmacology
Aripiprazole Lauroxil Psychiatry CYP2D6 Dosage and Administration, Use in Specific Populations, Clinical Pharmacology
Arsenic Trioxide Oncology PML-RARA Indications and Usage, Clinical Studies
Articaine and Epinephrine (1) Anesthesiology G6PD Warnings and Precautions
Articaine and Epinephrine (2) Anesthesiology Nonspecific
(Congenital Methemoglobinemia)
Warnings and Precautions
Atezolizumab (1) Oncology CD274
(PD-L1)
Indications and Usage, Dosage and Administration, Adverse Reactions, Clinical Pharmacology, Clinical Studies
Atezolizumab (2)   Oncology Gene Signature
(T-effector)
Clinical Studies
Atezolizumab (3) Oncology EGFR Indications and Usage, Clinical Studies
Atezolizumab (4) Oncology ALK Indications and Usage, Clinical Studies
Atomoxetine Psychiatry CYP2D6 Dosage and Administration, Warnings and Precautions, Adverse Reactions, Drug Interactions, Use in Specific Populations, Clinical Pharmacology
Ascorbic Acid, PEG-3350, Potassium Chloride, Sodium Ascorbate, Sodium Chloride, and Sodium Sulfate Gastroenterology G6PD Warnings and Precautions
Avatrombopag (1) Hematology F2
(Prothrombin)
Warnings and Precautions
Avatrombopag (2) Hematology F5
(Factor V Leiden)
Warnings and Precautions
Avatrombopag (3) Hematology PROC Warnings and Precautions
Avatrombopag (4) Hematology PROS1 Warnings and Precautions
Avatrombopag (5) Hematology SERPINC1
(Antithrombin III)
Warnings and Precautions
Avatrombopag (6) Hematology CYP2C9 Clinical Pharmacology
Avelumab Oncology CD274
(PD-L1)
Clinical Studies
Azathioprine (1) Rheumatology TPMT Dosage and Administration,  Warnings, Precautions, Drug Interactions, Adverse Reactions, Clinical Pharmacology
Azathioprine (2) Rheumatology NUDT15 Dosage and Administration, Warnings, Precautions, Adverse Reactions, Clinical Pharmacology
Belinostat Oncology UGT1A1 Dosage and Administration, Clinical Pharmacology
Binimetinib (1) Oncology BRAF Indications and Usage, Dosage and Administration, Warnings and Precautions, Adverse Reactions, Use in Specific Populations, Clinical Studies  
Binimetinib (2) Oncology UGT1A1 Clinical Pharmacology
Blinatumomab Oncology BCR-ABL1
(Philadelphia chromosome)
Adverse Reactions, Clinical Studies
Boceprevir Infectious Diseases IFNL3
(IL28B)
Clinical Pharmacology
Bosutinib Oncology BCR-ABL1
(Philadelphia chromosome)
Indications and Usage, Dosage and Administration, Warnings and Precautions, Adverse Reactions, Use in Specific Populations, Clinical Studies
Brentuximab Vedotin (1) Oncology ALK Clinical Studies
Brentuximab Vedotin (2) Oncology TNFRSF8
(CD30)
Indications and Usage, Dosage and Administration, Adverse Reactions, Use in Specific Populations, Clinical Studies
Brexpiprazole Psychiatry CYP2D6 Dosage and Administration, Use in Specific Populations, Clinical Pharmacology
Brigatinib Oncology ALK Indications and Usage, Adverse Reactions, Clinical Studies
Brivaracetam Neurology CYP2C19 Clinical Pharmacology
Busulfan Oncology BCR-ABL1
(Philadelphia chromosome)
Clinical Studies
Cabozantinib Oncology RET Clinical Studies
Capecitabine Oncology DPYD Warnings and Precautions, Patient Counseling Information
Carbamazepine (1) Neurology HLA-B Boxed Warning, Warnings, Precautions
Carbamazepine (2) Neurology HLA-A Warnings
Carglumic Acid Inborn Errors of Metabolism NAGS Indications and Usage, Dosage and Administration, Warnings and Precautions, Use in Specific Populations, Clinical Pharmacology, Clinical Studies
Cariprazine Psychiatry CYP2D6 Clinical Pharmacology
Carisoprodol Rheumatology CYP2C19 Use in Specific Populations, Clinical Pharmacology
Carvedilol Cardiology CYP2D6 Drug Interactions, Clinical Pharmacology
Ceftriaxone (1) Infectious Diseases G6PD Warnings
Ceftriaxone (2) Infectious Diseases Nonspecific
(Congenital Methemoglobinemia)
Warnings
Celecoxib Rheumatology CYP2C9 Dosage and Administration, Use in Specific Populations, Clinical Pharmacology
Ceritinib Oncology ALK Indications and Usage, Dosage and Administration, Warning and Precautions, Adverse Reactions, Clinical Studies
Cerliponase Alfa Inborn Errors of Metabolism TPP1 Indications and Usage, Use in Specific Populations, Clinical Studies
Cetuximab (1) Oncology EGFR Indications and Usage, Dosage and Administration, Adverse Reactions, Clinical Studies
Cetuximab (2) Oncology RAS Indications and Usage, Dosage and Administration, Warnings and Precautions, Adverse Reactions, Clinical Studies
Cevimeline Dental CYP2D6 Precautions
Chloroprocaine (1) Anesthesiology G6PD Warnings
Chloroprocaine (2) Anesthesiology Nonspecific
(Congenital Methemoglobinemia)
Warnings
Chloroquine Infectious Diseases G6PD Precautions, Adverse Reactions
Chlorpropamide Endocrinology G6PD Precautions
Cisplatin Oncology TPMT Adverse Reactions
Citalopram (1) Psychiatry CYP2C19 Dosage and Administration, Warnings, Clinical Pharmacology
Citalopram (2) Psychiatry CYP2D6 Clinical Pharmacology
Clobazam Neurology CYP2C19 Dosage and Administration, Use in Specific Populations, Clinical Pharmacology
Clomipramine Psychiatry CYP2D6 Precautions
Clopidogrel Cardiology CYP2C19 Boxed Warning, Warnings and Precautions, Clinical Pharmacology
Clozapine Psychiatry CYP2D6 Dosage and Administration, Use in Specific Populations, Clinical Pharmacology
Cobimetinib Oncology BRAF Indications and Usage, Dosage and Administration, Adverse Reactions, Clinical Studies
Codeine Anesthesiology CYP2D6 Boxed Warning, Warnings and Precautions, Use in Specific Populations, Patient Counseling Information
Crizotinib (1) Oncology ALK Indications and Usage, Dosage and Administration, Adverse Reactions, Use in Specific Populations, Clinical Pharmacology, Clinical Studies
Crizotinib (2) Oncology ROS1 Indications and Usage, Dosage and Administration, Adverse Reactions, Use in Specific Populations, Clinical Studies
Dabrafenib (1) Oncology BRAF Indications and Usage, Dosage and Administration, Warnings and Precautions, Adverse Reactions, Clinical Pharmacology, Clinical Studies, Patient Counseling Information
Dabrafenib (2) Oncology G6PD Warnings and Precautions, Adverse Reactions, Patient Counseling Information
Dabrafenib (3) Oncology RAS Dosage and Administration, Warnings and Precautions
Daclatasvir Infectious Diseases IFNL3
(IL28B)
Clinical Studies
Dacomitinib Oncology EGFR Indications and Usage, Dosage and Administration, Adverse Reactions, Use in Specific Populations, Clinical Studies
Dapsone (1) Dermatology G6PD Warnings and Precautions, Use in Specific Populations, Patient Counseling Information
Dapsone (2) Dermatology Nonspecific
(Congenital Methemoglobinemia)
Warnings and Precautions, Adverse Reactions, Patient Counseling Information
Dapsone (3) Infectious Diseases G6PD Precautions, Adverse Reactions, Overdosage
Darifenacin Urology CYP2D6 Clinical Pharmacology
Dasabuvir, Ombitasvir, Paritaprevir, and Ritonavir Infectious Diseases IFNL3
(IL28B)
Clinical Studies
Dasatinib Oncology BCR-ABL1
(Philadelphia chromosome)
Indications and Usage, Dosage and Administration, Warnings and Precautions, Adverse Reactions, Use in Specific Populations, Clinical Studies
Denileukin Diftitox Oncology IL2RA
(CD25 antigen)
Indications and Usage, Warnings and Precautions, Clinical Studies
Desipramine Psychiatry CYP2D6 Precautions
Desflurane Anesthesiology Nonspecific
(Genetic Susceptibility to Malignant Hyperthermia)
Contraindications
Desvenlafaxine Psychiatry CYP2D6 Clinical Pharmacology
Deutetrabenazine Neurology CYP2D6 Dosage and Administration, Warnings and Precautions, Use in Specific Populations, Clinical Pharmacology
Dexlansoprazole Gastroenterology CYP2C19 Drug Interactions, Clinical Pharmacology
Dextromethorphan and Quinidine Neurology CYP2D6 Warnings and Precautions, Clinical Pharmacology
Diazepam Neurology CYP2C19 Clinical Pharmacology
Dinutuximab Oncology MYCN Clinical Studies
Docetaxel Oncology ESR, PGR
(Hormone Receptor)
Clinical Studies
Dolutegravir Infectious Diseases UGT1A1 Clinical Pharmacology
Donepezil Neurology CYP2D6 Clinical Pharmacology
Doxepin (1) Psychiatry CYP2D6 Clinical Pharmacology
Doxepin (2) Psychiatry CYP2C19 Clinical Pharmacology
Dronabinol Gastroenterology CYP2C9 Use in Specific Populations, Clinical Pharmacology
Drospirenone and Ethinyl Estradiol Gynecology CYP2C19 Clinical Pharmacology
Duloxetine Psychiatry CYP2D6 Drug Interactions
Durvalumab Oncology CD274
(PD-L1)
Clinical Pharmacology, Clinical Studies
Duvelisib Oncology Chromosome 17p Clinical Studies
Efavirenz Infectious Diseases CYP2B6 Clinical Pharmacology
Elagolix Gynecology SLCO1B1 Clinical Pharmacology
Elbasvir and Grazoprevir Infectious Diseases IFNL3
(IL28B)
Clinical Studies
Eliglustat Inborn Errors of Metabolism CYP2D6 Indications and Usage, Dosage and Administration, Contraindications, Warnings and Precautions, Drug Interactions, Use in Specific Populations, Clinical Pharmacology, Clinical Studies
Elosulfase Inborn Errors of Metabolism GALNS Indications and Usage, Warnings and Precautions, Use in Specific Populations, Clinical Pharmacology, Clinical Studies
Eltrombopag (1) Hematology F5
(Factor V Leiden)
Warnings and Precautions
Eltrombopag (2) Hematology SERPINC1
(Antithrombin III)
Warnings and Precautions
Eltrombopag (3) Hematology Chromosome 7del Adverse Reactions
Eltrombopag (4) Hematology Chromosome 13del Adverse Reactions
Emapalumab-lzsg Hematology PRF1, RAB27A, SH2D1A, STXBP2, STX11, UNC13D, XIAP (Hemophagocytic Lymphohistiocytosis) Clinical Studies
Enasidenib Oncology IDH2 Indications and Usage, Dosage and Administration, Clinical Pharmacology, Clinical Studies
Encorafenib Oncology BRAF Indications and Usage, Dosage and Administration, Warnings and Precautions, Adverse Reactions, Use in Specific Populations, Clinical Pharmacology, Clinical Studies
Enflurane Anesthesiology Nonspecific
(Genetic Susceptibility to Malignant Hyperthermia)
Contraindications
Erdafitinib (1) Oncology FGFR Indications and Usage, Dosage and Administration, Adverse Reactions, Clinical Studies, Patient Counseling Information
Erdafitinib (2)  Oncology CYP2C9 Use in Specific Populations, Clinical Pharmacology
Eribulin (1) Oncology ERBB2
(HER2)
Clinical Studies
Eribulin (2) Oncology ESR, PGR
(Hormone Receptor)
Clinical Studies
Erlotinib Oncology EGFR Indications and Usage, Dosage and Administration, Adverse Reactions, Clinical Studies
Erythromycin and Sulfisoxazole Infectious Diseases G6PD Precautions
Escitalopram (1) Psychiatry CYP2D6 Drug Interactions
Escitalopram (2) Psychiatry CYP2C19 Adverse Reactions
Esomeprazole Gastroenterology CYP2C19 Drug Interactions, Clinical Pharmacology
Eteplirsen Neurology DMD Indications and Usage, Adverse Reactions, Use in Specific Populations, Clinical Studies
Everolimus (1) Oncology ERBB2
(HER2)
Indications and Usage, Dosage and Administration, Warnings and Precautions, Adverse Reactions, Use in Specific Populations, Clinical Pharmacology, Clinical Studies
Everolimus (2) Oncology ESR
(Hormone Receptor)
Indications and Usage, Dosage and Administration, Warnings and Precautions, Adverse Reactions, Use in Specific Populations, Clinical Pharmacology, Clinical Studies
Exemestane Oncology ESR, PGR
(Hormone Receptor)
Indications and Usage, Dosage and Administration, Clinical Studies
Fesoterodine Urology CYP2D6 Drug Interactions, Clinical Pharmacology
Fosphenytoin Neurology HLA-B Warnings and Precautions
Flibanserin (1) Gynecology CYP2C9 Clinical Pharmacology
Flibanserin (2) Gynecology CYP2C19 Adverse Reactions, Use in Specific Populations, Clinical Pharmacology
Flibanserin (3) Gynecology CYP2D6 Clinical Pharmacology
Fluorouracil (1) Dermatology DPYD Contraindications, Warnings
Fluorouracil (2) Oncology DPYD Warnings and Precautions, Patient Counseling Information
Fluoxetine Psychiatry CYP2D6 Precautions, Clinical Pharmacology
Flurbiprofen Rheumatology CYP2C9 Clinical Pharmacology
Flutamide Oncology G6PD Warnings
Fluvoxamine Psychiatry CYP2D6 Drug Interactions
Formoterol (1) Pulmonary CYP2D6 Clinical Pharmacology
Formoterol (2) Pulmonary CYP2C19 Clinical Pharmacology
Fulvestrant (1) Oncology ERBB2
(HER2)
Indications and Usage, Adverse Reactions, Clinical Studies
Fulvestrant (2) Oncology ESR, PGR
(Hormone Receptor)
Indications and Usage, Adverse Reactions, Clinical Pharmacology, Clinical Studies
Galantamine Neurology CYP2D6 Clinical Pharmacology
Gefitinib (1) Oncology EGFR Indications and Usage, Dosage and Administration, Clinical Studies
Gefitinib (2) Oncology CYP2D6 Clinical Pharmacology
Gilteritinib Oncology FLT3 Indications and Usage, Dosage and Administration, Clinical Studies
Glimepiride Endocrinology G6PD Warnings and Precautions, Adverse Reactions
Glipizide Endocrinology G6PD Precautions
Glyburide Endocrinology G6PD Precautions
Goserelin Oncology ESR, PGR
(Hormone Receptor)
Indications and Usage, Clinical Studies
Hydralazine Cardiology Nonspecific
(NAT)
Clinical Pharmacology
Hydroxychloroquine Infectious Diseases G6PD Precautions, Adverse Reactions
Ibrutinib (1) Oncology Chromosome 17p Indications and Usage, Clinical Studies
Ibrutinib (2) Oncology Chromosome 11q Clinical Studies
Iloperidone Psychiatry CYP2D6 Dosage and Administration, Warnings and Precautions, Drug Interactions, Clinical Pharmacology
Imatinib (1) Oncology KIT Indications and Usage, Dosage and Administration, Clinical Studies
Imatinib (2) Oncology BCR-ABL1
(Philadelphia chromosome)
Indications and Usage, Dosage and Administration, Warnings and Precautions, Adverse Reactions, Use in Specific Populations, Clinical Pharmacology, Clinical Studies
Imatinib (3) Oncology PDGFRB Indications and Usage, Dosage and Administration, Clinical Studies
Imatinib (4) Oncology FIP1L1-PDGFRA Indications and Usage, Dosage and Administration, Clinical Studies
Imipramine Psychiatry CYP2D6 Precautions
Indacaterol Pulmonary UGT1A1 Clinical Pharmacology
Inotersen Neurology TTR Adverse Reactions, Clinical Pharmacology
Inotuzumab Ozogamicin Oncology BCR-ABL1
(Philadelphia chromosome)
Clinical Studies
Ipilimumab (1) Oncology HLA-A Clinical Studies
Ipilimumab (2) Oncology Microsatellite Instability, Mismatch Repair Indications and Usage, Adverse Reactions, Use in Specific Populations, Clinical Studies
Irinotecan Oncology UGT1A1 Dosage and Administration, Warnings and Precautions, Clinical Pharmacology
Isoflurane Anesthesiology Nonspecific
(Genetic Susceptibility to Malignant Hyperthermia)
Contraindications
Isoniazid, Pyrazinamide, and Rifampin Infectious Diseases Nonspecific
(NAT)
Clinical Pharmacology
Isosorbide Dinitrate Cardiology CYB5R Overdosage
Isosorbide Mononitrate Cardiology CYB5R Overdosage
Ivacaftor Pulmonary CFTR Indications and Usage, Adverse Reactions, Use in Specific Populations, Clinical Pharmacology, Clinical Studies
Ivacaftor and Lumacaftor Pulmonary CFTR Indications and Usage, Adverse Reactions, Use in Specific Populations, Clinical Studies
Ivacaftor and Tezacaftor Pulmonary CFTR Indications and Usage, Adverse Reactions, Use in Specific Populations, Clinical Pharmacology, Clinical Studies
Ivosidenib Oncology IDH1 Indications and Usage, Dosage and Administration, Clinical Pharmacology, Clinical Studies
Ixabepilone (1) Oncology ERBB2
(HER2)
Clinical Studies
Ixabepilone (2) Oncology ESR, PGR
(Hormone Receptor)
Clinical Studies
Lacosamide Neurology CYP2C19 Clinical Pharmacology
Lansoprazole Gastroenterology CYP2C19 Drug Interactions, Clinical Pharmacology
Lapatinib (1) Oncology ERBB2
(HER2)
Indications and Usage, Dosage and Administration, Adverse Reactions, Use in Specific Populations, Clinical Studies
Lapatinib (2) Oncology ESR, PGR
(Hormone Receptor)
Indications and Usage, Dosage and Administration, Adverse Reactions, Use in Specific Populations, Clinical Studies
Lapatinib (3) Oncology HLA-DQA1, HLA-DRB1 Clinical Pharmacology
Larotrectinib Oncology NTRK Indications and Usage, Dosage and Administration, Adverse Reactions, Clinical Studies
Ledipasvir and Sofosbuvir Infectious Diseases IFNL3
(IL28B)
Clinical Studies
Lenalidomide Hematology Chromosome 5q Boxed Warning, Indications and Usage, Adverse Reactions, Use in Specific Populations, Clinical Studies
Lesinurad Rheumatology CYP2C9 Drug Interactions, Clinical Pharmacology
Letrozole Oncology ESR, PGR
(Hormone Receptor)
Indications and Usage, Adverse Reactions, Clinical Studies
Lidocaine and Prilocaine (1) Anesthesiology Nonspecific
(Congenital Methemoglobinemia)
Warnings and Precautions
Lidocaine and Prilocaine (2) Anesthesiology G6PD Warnings and Precautions, Clinical Pharmacology
Lidocaine and Tetracaine (1) Anesthesiology G6PD Warnings and Precautions
Lidocaine and Tetracaine (2) Anesthesiology Nonspecific
(Congenital Methemoglobinemia)
Warnings and Precautions
Lofexidine Anesthesiology CYP2D6 Use in Specific Populations
Lorlatinib (1) Oncology ALK Indications and Usage, Adverse Reactions, Clinical Studies
Lorlatinib (2) Oncology ROS1 Adverse Reactions
Lusutrombopag (1) Hematology F2
(Prothrombin)
Warnings and Precautions
Lusutrombopag (2) Hematology F5
(Factor V Leiden)
Warnings and Precautions
Lusutrombopag (3) Hematology PROC Warnings and Precautions
Lusutrombopag (4) Hematology PROS1 Warnings and Precautions
Lusutrombopag (5) Hematology SERPINC1
(Antithrombin III)
Warnings and Precautions
Mafenide Infectious Diseases G6PD Warnings, Adverse Reactions
Meclizine Neurology CYP2D6 Warnings and Precautions
Mepivacaine (1) Anesthesiology G6PD Warnings
Mepivacaine (2) Anesthesiology Nonspecific
(Congenital Methemoglobinemia)
Warnings
Mercaptopurine (1) Oncology TPMT Dosage and Administration, Warnings and Precautions, Adverse Reactions, Clinical Pharmacology
Mercaptopurine (2) Oncology NUDT15 Dosage and Administration, Warnings and Precautions, Clinical Pharmacology
Methylene Blue Hematology G6PD Contraindications, Warnings and Precautions
Metoclopramide (1) Gastroenterology CYB5R Use in Specific Populations
Metoclopramide (2) Gastroenterology G6PD Use in Specific Populations, Overdosage
Metoclopramide (3) Gastroenterology CYP2D6 Dosage and Administration, Use in Specific Populations, Clinical Pharmacology
Metoprolol Cardiology CYP2D6 Drug Interactions, Clinical Pharmacology
Midostaurin (1) Oncology FLT3 Indications and Usage, Dosage and Administration, Adverse Reactions, Clinical Studies
Midostaurin (2) Oncology NPM1 Clinical Studies
Midostaurin (3) Oncology KIT Clinical Studies
Migalastat Inborn Errors of Metabolism GLA Indications and Usage, Dosage and Administration, Clinical Pharmacology, Clinical Studies
Mirabegron Urology CYP2D6 Clinical Pharmacology
Mivacurium Anesthesiology BCHE Warnings, Precautions, Clinical Pharmacology
Modafinil Psychiatry CYP2D6 Clinical Pharmacology
Mycophenolic Acid Transplantation HPRT1 Warnings and Precautions
Nalidixic Acid Infectious Diseases G6PD Precautions, Adverse Reactions
Nebivolol Cardiology CYP2D6 Dosage and Administration, Clinical Pharmacology
Nefazodone Psychiatry CYP2D6 Precautions
Neratinib (1) Oncology ERBB2
(HER2)

Indications and Usage, Adverse Reactions, Clinical Studies

Neratinib (2) Oncology ESR, PGR
(Hormone Receptor)

Clinical Studies

Nilotinib (1) Oncology BCR-ABL1
(Philadelphia chromosome)
Indications and Usage, Dosage and Administration, Warnings and Precautions, Adverse Reactions, Use in Specific Populations, Clinical Pharmacology, Clinical Studies
Nilotinib (2) Oncology UGT1A1 Clinical Pharmacology
Niraparib Oncology BRCA Clinical Studies
Nitrofurantoin Infectious Diseases G6PD Warnings, Adverse Reactions
Nivolumab (1) Oncology BRAF Adverse Reactions, Clinical Studies
Nivolumab (2) Oncology CD274
(PD-L1)
Clinical Pharmacology, Clinical Studies
Nivolumab (3) Oncology Microsatellite Instability, Mismatch Repair Indications and Usage, Clinical Studies
Nortriptyline Psychiatry CYP2D6 Precautions
Nusinersen Neurology SMN2 Clinical Pharmacology, Clinical Studies
Obinutuzumab Oncology MS4A1
(CD20 antigen)
Clinical Studies
Olaparib (1) Oncology BRCA Indications and Usage, Dosage and Administration, Warnings and Precautions, Adverse Reactions, Clinical Studies
Olaparib (2) Oncology ERBB2
(HER2)
Indications and Usage, Dosage and Administration, Adverse Reactions, Clinical Studies
Olaparib (3) Oncology ESR, PGR
(Hormone Receptor)

Indications and Usage, Clinical Studies

Olaratumab Oncology PDGFRA Clinical Studies
Omacetaxine Oncology BCR-ABL1
(Philadelphia chromosome)
Clinical Studies
Ombitasvir, Paritaprevir, and Ritonavir Infectious Diseases IFNL3
(IL28B)
Clinical Studies
Omeprazole Gastroenterology CYP2C19 Drug Interactions, Clinical Pharmacology
Oxymetazoline and Tetracaine (1) Anesthesiology G6PD Warnings and Precautions
Oxymetazoline and Tetracaine (2) Anesthesiology Nonspecific
(Congenital Methemoglobinemia)
Warnings and Precautions
Ondansetron Gastroenterology CYP2D6 Clinical Pharmacology
Osimertinib Oncology EGFR Indications and Usage, Dosage and Administration, Adverse Reactions, Clinical Studies
Ospemifene (1) Gynecology CYP2C9 Clinical Pharmacology
Ospemifene (2) Gynecology CYP2B6 Clinical Pharmacology
Oxcarbazepine Neurology HLA-B Warnings and Precautions
Palbociclib (1) Oncology ESR
(Hormone Receptor)
Indications and Usage, Adverse Reactions, Clinical Studies
Palbociclib (2) Oncology ERBB2
(HER2)
Indications and Usage, Adverse Reactions, Clinical Studies
Paliperidone Psychiatry CYP2D6 Clinical Pharmacology
Palonosetron Gastroenterology CYP2D6 Clinical Pharmacology
Panitumumab (1) Oncology EGFR Adverse Reactions, Clinical Pharmacology, Clinical Studies
Panitumumab (2) Oncology RAS Indications and Usage, Dosage and Administration, Warnings and Precautions, Adverse Reactions, Clinical Studies
Pantoprazole Gastroenterology CYP2C19 Clinical Pharmacology
Parathyroid Hormone Inborn Errors of Metabolism CASR Indications and Usage, Clinical Studies
Paroxetine Psychiatry CYP2D6 Drug Interactions
Patisiran Neurology TTR Adverse Reactions, Clinical Pharmacology, Clinical Studies
Pazopanib (1) Oncology UGT1A1 Clinical Pharmacology
Pazopanib (2) Oncology HLA-B Clinical Pharmacology
Peginterferon Alfa-2b Infectious Diseases IFNL3
(IL28B)
Clinical Pharmacology
Pegloticase Rheumatology G6PD Boxed Warning, Contraindications, Warnings and Precautions, Patient Counseling Information
Pembrolizumab (1) Oncology BRAF Adverse Reactions, Clinical Studies
Pembrolizumab (2) Oncology CD274
(PD-L1)
Indications and Usage, Dosage and Administration, Clinical Studies
Pembrolizumab (3) Oncology Microsatellite Instability, Mismatch Repair Indications and Usage,
Dosage and Administration, Use in Specific Populations, Clinical Studies 
Pembrolizumab (4) Oncology EGFR Indications and Usage, Adverse Reactions, Clinical Studies
Pembrolizumab (5) Oncology ALK Indications and Usage, Adverse Reactions, Clinical Studies
Perphenazine Psychiatry CYP2D6 Precautions, Clinical Pharmacology
Pertuzumab (1) Oncology ERBB2
(HER2)
Indications and Usage, Dosage and Administration, Warnings and Precautions, Adverse Reactions, Clinical Pharmacology, Clinical Studies
Pertuzumab (2) Oncology ESR, PGR
(Hormone Receptor)
Clinical Studies
Phenytoin (1) Neurology CYP2C9 Clinical Pharmacology
Phenytoin (2) Neurology CYP2C19 Clinical Pharmacology
Phenytoin (3) Neurology HLA-B Warnings
Pimozide Psychiatry CYP2D6 Dosage and Administration, Precautions
Piroxicam Rheumatology CYP2C9 Clinical Pharmacology
Ponatinib Oncology BCR-ABL1
(Philadelphia chromosome)
Indications and Usage, Warnings and Precautions, Adverse Reactions, Use in Specific Populations, Clinical Studies
Prasugrel (1) Cardiology CYP2C19 Use in Specific Populations, Clinical Pharmacology, Clinical Studies
Prasugrel (2) Cardiology CYP2C9 Use in Specific Populations, Clinical Pharmacology, Clinical Studies
Prasugrel (3) Cardiology CYP3A5 Use in Specific Populations, Clinical Pharmacology, Clinical Studies
Prasugrel (4) Cardiology CYP2B6 Use in Specific Populations, Clinical Pharmacology, Clinical Studies
Primaquine (1) Infectious Diseases G6PD Contraindications, Warnings, Precautions, Adverse Reactions, Overdosage
Primaquine (2)  Infectious Diseases CYB5R Precautions, Adverse Reactions
Probenecid Rheumatology G6PD Adverse Reactions
Procainamide Cardiology Nonspecific
(NAT)
Adverse Reactions, Clinical Pharmacology
Propafenone Cardiology CYP2D6 Dosage and Administration, Warnings and Precautions, Drug Interactions, Clinical Pharmacology
Propranolol Cardiology CYP2D6 Clinical Pharmacology
Protriptyline Psychiatry CYP2D6 Precautions
Quinidine Cardiology CYP2D6 Precautions
Quinine Sulfate (1) Infectious Diseases G6PD Warnings and Precautions
Quinine Sulfate (2) Infectious Diseases CYP2D6 Drug Interactions
Rabeprazole Gastroenterology CYP2C19 Drug Interactions, Clinical Pharmacology
Raloxifene Oncology ESR
(Hormone Receptor)
Clinical Studies
Raltegravir Infectious Diseases UGT1A1 Clinical Pharmacology
Ramucirumab (1) Oncology EGFR Clinical Studies
Ramucirumab (2) Oncology RAS Clinical Studies
Rasburicase (1) Oncology G6PD Boxed Warning, Contraindications, Warnings and Precautions
Rasburicase (2) Oncology CYB5R Boxed Warning, Contraindications, Warnings and Precautions
Regorafenib Oncology RAS Indications and Usage, Clinical Studies
Ribociclib (1) Oncology ESR, PGR
(Hormone Receptor)
Indications and Usage, Adverse Reactions, Clinical Studies
Ribociclib (2) Oncology ERBB2
(HER2)
Indications and Usage, Adverse Reactions, Clinical Studies
Risperidone Psychiatry CYP2D6 Clinical Pharmacology
Rituximab Oncology MS4A1
(CD20 antigen)
Indications and Usage, Dosage and Administration, Adverse Reactions, Use in Specific Populations, Clinical Studies
Rivaroxaban Cardiology F5
(Factor V Leiden)
Clinical Studies
Ropivacaine (1) Anesthesiology G6PD Warnings
Ropivacaine (2) Anesthesiology Nonspecific
(Congenital Methemoglobinemia)
Warnings
Rosuvastatin Endocrinology SLCO1B1 Clinical Pharmacology
Rucaparib (1) Oncology BRCA Indications and Usage, Dosage and Administration, Adverse Reactions, Use in Specific Populations, Clinical Studies
Rucaparib (2) Oncology CYP2D6 Clinical Pharmacology
Rucaparib (3) Oncology CYP1A2 Clinical Pharmacology
Rucaparib (4) Oncology Homologous Recombination Deficiency Clinical Studies
Sevoflurane Anesthesiology RYR1 Warnings
Simeprevir Infectious Diseases IFNL3
(IL28B)
Clinical Pharmacology, Clinical Studies
Siponimod Neurology CYP2C9 Dosage and Administration, Contraindications, Drug Interactions, Use in Specific Populations, Clinical Pharmacology
Sodium Nitrite (1) Toxicology G6PD Warnings and Precautions
Sodium Nitrite (2) Toxicology Nonspecific
(Congenital Methemoglobinemia)
Boxed Warning, Warnings and Precautions
Sodium Phenylbutyrate Inborn Errors of Metabolism ASS1, CPS1, OTC
(Urea Cycle Disorders)
Indications and Usage, Dosage and Administration
Sofosbuvir Infectious Diseases IFNL3
(IL28B)
Clinical Studies
Sofosbuvir and Velpatasvir Infectious Diseases IFNL3
(IL28B)
Clinical Studies
Sofosbuvir, Velpatasvir, and Voxilaprevir Infectious Diseases IFNL3
(IL28B)
Clinical Studies
Succimer Hematology G6PD Clinical Pharmacology
Succinylcholine Anesthesiology BCHE Warnings, Precautions
Sulfadiazine Infectious Diseases G6PD Warnings
Sulfamethoxazole and Trimethoprim (1) Infectious Diseases G6PD Precautions
Sulfamethoxazole and Trimethoprim (2) Infectious Diseases Nonspecific
(NAT)
Precautions
Sulfasalazine (1) Gastroenterology G6PD Precautions
Sulfasalazine (2) Gastroenterology Nonspecific
(NAT)
Clinical Pharmacology
Tafamidis Cardiology TTR Clinical Pharmacology, Clinical Studies
Tafenoquine Infectious Diseases G6PD Dosage and Administration, Contraindications, Warnings and Precautions, Use in Specific Populations, Patient Counseling Information
Talazoparib (1) Oncology BRCA Indications and Usage, Dosage and Administration, Adverse Reactions, Clinical Studies
Talazoparib (2) Oncology ERBB2
(HER2)
Indications and Usage, Adverse Reactions, Clinical Studies
Tamoxifen (1) Oncology ESR, PGR
(Hormone Receptor)
Indications and Usage, Adverse Reactions, Clinical Pharmacology, Clinical Studies
Tamoxifen (2) Oncology F5
(Factor V Leiden)
Warnings and Precautions
Tamoxifen (3) Oncology F2
(Prothrombin)
Warnings and Precautions
Tamoxifen (4) Oncology CYP2D6 Clinical Pharmacology
Tamsulosin Urology CYP2D6 Warnings and Precautions, Adverse Interactions, Clinical Pharmacology
Telaprevir Infectious Diseases IFNL3
(IL28B)
Clinical Pharmacology, Clinical Studies
Tetrabenazine Neurology CYP2D6 Dosage and Administration, Warnings and Precautions, Use in Specific Populations, Clinical Pharmacology
Thioguanine (1) Oncology TPMT Dosage and Administration, Warnings, Precautions, Clinical Pharmacology
Thioguanine (2) Oncology NUDT15 Dosage and Administration, Warnings, Precautions, Clinical Pharmacology
Thioridazine  Psychiatry CYP2D6 Contraindications, Warnings, Precautions
Ticagrelor Cardiology CYP2C19 Clinical Pharmacology
Tipiracil and Trifluridine (1) Oncology ERBB2
(HER2)
Clinical Studies
Tipiracil and Trifluridine (2) Oncology RAS Clinical Studies
Tolazamide Endocrinology G6PD Precautions
Tolbutamide Endocrinology G6PD Precautions
Tolterodine Urology CYP2D6 Warnings and Precautions, Drug Interactions, Clinical Pharmacology
Toremifene Oncology ESR
(Hormone Receptor)
Indications and Usage, Clinical Studies
Tramadol Anesthesiology CYP2D6 Boxed Warning, Warnings and Precautions, Use in Specific Populations, Clinical Pharmacology, Patient Counseling Information
Trametinib (1) Oncology BRAF Indications and Usage, Dosage and Administration, Adverse Reactions, Clinical Pharmacology, Clinical Studies, Patient Counseling Information
Trametinib (2) Oncology G6PD Adverse Reactions
Trametinib (3) Oncology RAS Warnings and Precautions
Trastuzumab (1) Oncology ERBB2
(HER2)
Indications and Usage, Dosage and Administration, Clinical Pharmacology, Clinical Studies
Trastuzumab (2) Oncology ESR, PGR
(Hormone Receptor)
Clinical Studies
Tretinoin Oncology PML-RARA Indications and Usage, Warnings, Clinical Pharmacology
Trimipramine Psychiatry CYP2D6 Precautions
Umeclidinium Pulmonary CYP2D6 Clinical Pharmacology
Ustekinumab Dermatology and Gastroenterology IL12A, IL12B, IL23A Warnings and Precautions
Valbenazine Neurology CYP2D6 Dosage and Administration, Warnings and Precautions, Use in Specific Populations, Clinical Pharmacology
Valproic Acid (1) Neurology POLG Boxed Warning, Contraindications, Warnings and Precautions
Valproic Acid (2) Neurology Nonspecific
(Urea Cycle Disorders)
Contraindications, Warnings and Precautions
Vemurafenib (1) Oncology BRAF Indications and Usage, Dosage and Administration, Warnings and Precautions, Adverse Reactions, Use in Specific Populations, Clinical Pharmacology, Clinical Studies, Patient Counseling Information
Vemurafenib (2) Oncology RAS Warnings and Precautions, Adverse Reactions
Venetoclax (1) Oncology Chromosome 17p Clinical Studies
Venetoclax (2) Oncology Chromosome 11q Clinical Studies
Venetoclax (3) Oncology TP53 Clinical Studies
Venetoclax (4) Oncology IDH1 Clinical Studies
Venetoclax (5) Oncology IDH2 Clinical Studies
Venetoclax (6) Oncology IGH Clinical Studies
Venetoclax (7) Oncology NPM1 Clinical Studies
Venetoclax (8) Oncology FLT3 Clinical Studies
Venlafaxine Psychiatry CYP2D6 Drug Interactions, Use in Specific Populations, Clinical Pharmacology
Vincristine Oncology BCR-ABL1
(Philadelphia chromosome)
Indications and Usage, Adverse Reactions, Clinical Studies
Voriconazole Infectious Diseases CYP2C19 Clinical Pharmacology
Vortioxetine Psychiatry CYP2D6 Dosage and Administration, Clinical Pharmacology
Warfarin (1) Hematology CYP2C9 Dosage and Administration, Drug Interactions, Clinical Pharmacology
Warfarin (2) Hematology VKORC1 Dosage and Administration, Clinical Pharmacology
Warfarin (3) Hematology PROS1 Warnings and Precautions
Warfarin (4) Hematology PROC Warnings and Precautions
 * Therapeutic areas do not necessarily reflect the CDER review division.
† Representative biomarkers are listed based on standard nomenclature as per the Human Genome Organization (HUGO) symbol and/or simplified descriptors using other common conventions. Listed biomarkers do not necessarily reflect the terminology used in labeling. The term “Nonspecific” is provided when labeling does not explicitly identify the specific biomarker(s) or when the biomarker is represented by a molecular phenotype or gene signature, and in some cases the biomarker was inferred based on the labeling language. For detailed information on the biomarkers used in labeling, refer to the Labeling Text PDF.