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. 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.

Pharmacogenomic Biomarkers in Drug Labeling

DrugTherapeutic Area*Biomarker†Referenced Subgroup‡Labeling 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

Alectinib

Oncology

ALK

ALK gene rearrangement positive

Indications and Usage, Adverse Reactions, Clinical Pharmacology, Clinical Studies

Alirocumab

Endocrinology

LDLR

LDL receptor mutation heterozygotes

Indications and Usage, Adverse Reactions, 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, Use in Specific Populations, Drug Interactions, Clinical Pharmacology

Aripiprazole Lauroxil

Psychiatry

CYP2D6

CYP2D6 poor metabolizers

Dosage and Administration, Use in Specific Populations, 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

Belinostat

Oncology

UGT1A1

UGT1A1*28 allele homozygotes

Dosage and Administration, Clinical Pharmacology

Blinatumomab

Oncology

BCR-ABL1

Philadelphia chromosome negative

Indications and Usage, Clinical Studies

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

Brexpiprazole

Psychiatry

CYP2D6

CYP2D6 poor metabolizers

Dosage and Administration, Drug Interactions, Use in Specific Populations, Clinical Pharmacology

Busulfan

Oncology

BCR-ABL1

Philadelphia chromosome negative

Clinical Studies

Cabozantinib

Oncology

RET

RET mutation positive

Clinical Studies

Capecitabine

Oncology

DPYD

DPD deficient

Warnings and Precautions, Patient Counseling 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

Cholic Acid

Inborn Errors of Metabolism

AKR1D1, HSD3B7, CYP27A1, AMACR, CYP7A1

Bile acid synthesis enzyme deficient

Indications and Usage, Warnings and Precautions, Adverse Reactions, Use in Specific Populations, Clinical Pharmacology, Clinical Studies

Cisplatin

Oncology

TPMT

TPMT intermediate or poor metabolizers

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

Cobimetinib

Oncology

BRAF

BRAF V600E/K mutation positive

Indications and Usage, Dosage and Administration, Adverse Reactions, Clinical Pharmacology, Clinical Studies

Codeine

Anesthesiology

CYP2D6

CYP2D6 ultrarapid metabolizers

Boxed Warning, 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

Neurology

CYP2C19

CYP2C19 poor metabolizers

Clinical Pharmacology

Dinutuximab

Oncology

MYCN

MYCN amplification positive

Clinical Studies

Dolutegravir

Infectious Diseases

UGT1A1

UGT1A1 poor metabolizers

Clinical Pharmacology

Doxepin (1)

Psychiatry

CYP2D6

CYP2D6 poor metabolizers

Clinical Pharmacology

Doxepin (2)

Psychiatry

CYP2C19

CYP2C19 poor metabolizers

Clinical Pharmacology

Drospirenone and Ethinyl Estradiol

Gynecology

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

Elosulfase

Inborn Errors of Metabolism

GALNS

N-acetylgalactosamine-6-sulfatase deficient

Indications and Usage, Warnings and Precautions, 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

Escitalopram (1)

Psychiatry

CYP2D6

CYP2D6 poor metabolizers

Drug Interactions

Escitalopram (2)

Psychiatry

CYP2C19

CYP2C19 poor metabolizers

Adverse Reactions

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

Evolocumab

Endocrinology

LDLR

LDL receptor mutation heterozygotes and homozygotes

Indications and Usage, Dosage and Administration, Adverse Reactions, Use in Specific Populations, 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

Fesoterodine

Urology

CYP2D6

CYP2D6 poor metabolizers

Drug Interactions, Clinical Pharmacology

Fluorouracil (1)

Dermatology

DPYD

DPD deficient

Contraindications, Warnings

Fluorouracil (2)

Oncology

DPYD

DPD deficient

Warnings

Fluoxetine

Psychiatry

CYP2D6

CYP2D6 poor metabolizers

Warnings and Precautions, Drug Interactions, Clinical Pharmacology

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

Gefitinib

Oncology

EGFR

EGFR exon 19 deletions or exon 21 substitution (L858R) mutation positive

Indications and Usage, Dosage and Administration, Clinical Pharmacology, Clinical Studies

Glimepiride

Endocrinology

G6PD

G6PD deficient

Warnings and Precautions, Adverse Reactions

Glipizide

Endocrinology

G6PD

G6PD deficient

Precautions

Glyburide

Endocrinology

G6PD

G6PD deficient

Precautions

Hydralazine

Cardiology

NAT1-2

NAT 1-2 slow acetylators

Clinical Pharmacology

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, Clinical 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

Ivacaftor

Pulmonary

CFTR

CFTR G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N, S549R, R117H mutation positive, F508del mutation homozygotes

Indications and Usage, Adverse Reactions, Use in Specific Populations, Clinical Pharmacology, Clinical Studies

Lacosamide

Neurology

CYP2C19

CYP2C19 poor metabolizers

Clinical Pharmacology

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 HLA-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

Lesinurad

Rheumatology

CYP2C9

CYP2C9 poor metabolizers

Clinical Pharmacology

Letrozole

Oncology

ESR1, PGR

Hormone receptor positive

Indications and Usage, Adverse Reactions, Clinical Pharmacology, Clinical Studies

Lomitapide

Endocrinology

LDLR

LDL receptor mutation homozygotes

Indication and Usage, Warnings and Precautions, Adverse Reactions, Clinical Studies

Ivacaftor and Lumacaftor

Pulmonary

CFTR

CFTR F508del mutation homozygotes

Indications and Usage, Adverse Reactions, Clinical Pharmacology, 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 (1)

Gastroenterology

CYB5R1-4

NADH cytochrome b5 reductase deficient

Precautions

Metoclopramide (2)

Gastroenterology

G6PD

G6PD deficient

Precautions

Metoprolol

Cardiology

CYP2D6

CYP2D6 poor metabolizers

Clinical Pharmacology

Mipomersen

Endocrinology

LDLR

LDL receptor mutation heterozygotes and homozygotes

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-ABL1

Philadelphia chromosome positive

Indications and Usage, Dosage and Administration, Adverse Reactions, Use in Specific Populations, Clinical Pharmacology, Clinical Studies

Nilotinib (2)

Oncology

UGT1A1

UGT1A1*28 allele homozygotes

Clinical Pharmacology

Nitrofurantoin

Infectious Diseases

G6PD

G6PD deficient

Warnings, Adverse Reactions

Nivolumab (1)

Oncology

BRAF

BRAF V600 mutation positive

Indications and Usage, Adverse Reactions, Clinical Studies

Nivolumab (2)

Oncology

CD274

PD-L1 protein expression positive

Clinical Pharmacology

Nortriptyline

Psychiatry

CYP2D6

CYP2D6 poor metabolizers

Precautions

Obinutuzumab

Oncology

MS4A1

CD20 antigen positive

Clinical Studies

Olaparib

Oncology

BRCA1-2

BRCA1-2 mutation positive

Indications and Usage, Dosage and Administration, Warnings and Precautions, Adverse Reactions, Clinical Pharmacology, Clinical Studies

Omacetaxine

Oncology

BCR-ABL1

Philadelphia chromosome positive

Clinical Pharmacology, Clinical Studies

Ombitasvir,   Paritaprevir, Ritonavir, and Dasabuvir

Infectious Diseases

IFNL3

IL28B rs12979860 T allele carriers (non-C/C genotype)

Clinical Studies

Omeprazole

Gastroenterology

CYP2C19

CYP2C19 poor metabolizers

Drug Interactions

Osimertinib

Oncology

EGFR

EGFR T790M mutation positive

Indications and Usage, Dosage and Administration, Adverse Reactions, Clinical Pharmacology, Clinical Studies

Palbociclib (1)

Oncology

ESR1

Estrogen receptor positive

Indications and Usage, Adverse Reactions, Clinical Pharmacology, Clinical Studies

Palbociclib (2)

Oncology

ERBB2

HER2 protein overexpression negative

Indications and Usage, Adverse Reactions, Clinical Studies

Palonosetron

Gastroenterology

CYP2D6

CYP2D6 poor metabolizers

Clinical Pharmacology

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

Parathyroid Hormone

Inborn Errors of Metabolism

CASR

Calcium sensing receptor mutation positive

Indications and Usage, Clinical Studies

Paroxetine

Psychiatry

CYP2D6

CYP2D6 extensive and poor metabolizers

Drug Interactions, Clinical Pharmacology

Pazopanib

Oncology

UGT1A1

UGT1A1*28 allele homozygotes

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

Pembrolizumab (1)

Oncology

BRAF

BRAF V600 mutation positive

Indications and Usage, Adverse Reactions, Clinical Studies

Pembrolizumab (2)

Oncology

CD274

PD-L1 protein expression positive

Indications and Usage, Dosage and Administration, Clinical Pharmacology, Clinical Studies

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 (1)

Neurology

CYP2C9

CYP2C9 variant allele carriers

Clinical Pharmacology

Phenytoin (2)

Neurology

CYP2C19

CYP2C19 variant allele carriers

Clinical Pharmacology

Phenytoin (3)

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 allele carriers

Use in Specific Populations, Clinical Pharmacology, Clinical Studies

Prasugrel (3)

Cardiology

CYP3A5

CYP3A5 variant allele carriers

Use in Specific Populations, Clinical Pharmacology, Clinical Studies

Prasugrel (4)

Cardiology

CYP2B6

CYP2B6 variant allele carriers

Use in Specific Populations, Clinical Pharmacology, Clinical Studies

Pravastatin

Endocrinology

LDLR

LDL receptor mutation heterozygotes and homozygotes

Indications and Usage, Use in Specific Populations, Clinical Studies

Prilocaine and Lidocaine (1)

Anesthesiology

CYB5R1-4

NADH cytochrome b5 reductase deficient

Warnings and Precautions

Prilocaine and Lidocaine (2)

Anesthesiology

G6PD

G6PD deficient

Warnings and Precautions

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

Boxed Warning, Warnings and Precautions

Rifampin, Isoniazid, and Pyrazinamide

Infectious Diseases

NAT1-2

NAT 1-2 slow acetylators

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

Rosuvastatin (1)

Endocrinology

SLCO1B1

SLCO1B1 reduced function allele homozygotes

Clinical Pharmacology

Rosuvastatin (2)

Endocrinology

LDLR

LDL receptor mutation heterozygotes and homozygotes

Indications and Usage, Dosage and Administration, Adverse Reactions, Use in Specific Populations, Clinical Pharmacology, Clinical Studies

Sevoflurane

Anesthesiology

RYR1

Ryanodine receptor mutation positive

Warnings

Simeprevir

Infectious Diseases

IFNL3

IL28B rs12979860 T allele carriers (non-C/C genotype)

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)

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

Tamoxifen (2)

Oncology

F5

Factor V Leiden carriers

Warnings

Tamoxifen (3)

Oncology

F2

Prothrombin G20210A allele positive

Warnings

Telaprevir

Infectious Diseases

IFNL3

IL28B rs12979860 T allele carriers (C/T and T/T genotype)

Clinical Pharmacology, Clinical Studies

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

Warnings, Precautions, Dosage and Administration

Thioridazine

Psychiatry

CYP2D6

CYP2D6 poor metabolizers

Contraindications, Warnings, Precautions

Ticagrelor

Cardiology

CYP2C19

CYP2C19 poor metabolizers

Clinical Studies

Tolterodine

Urology

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

Anesthesiology

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 or gene amplification 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 (1)

Oncology

BRAF

BRAF V600E mutation positive

Indications and Usage, Dosage and Administration, Warnings and Precautions, Clinical Pharmacology, Clinical Studies, Patient Counseling Information

Vemurafenib (2)

Oncology

NRAS

NRAS mutation positive

Warnings and Precautions, Adverse Reactions

Venlafaxine

Psychiatry

CYP2D6

CYP2D6 poor metabolizers

Precautions

Voriconazole

Infectious Diseases

CYP2C19

CYP2C19 intermediate or poor metabolizers

Clinical Pharmacology

Vortioxetine

Psychiatry

CYP2D6

CYP2D6 poor metabolizers

Dosage and Administration, Clinical Pharmacology

Warfarin (1)

Hematology

CYP2C9

CYP2C9 intermediate or poor metabolizers

Dosage and Administration, Drug Interactions, Clinical Pharmacology

Warfarin (2)

Hematology

VKORC1

VKORC1 rs9923231 A allele carriers

Dosage and Administration, Clinical Pharmacology

Warfarin (3)

Hematology

PROS1

Protein S deficient

Warnings and Precautions

Warfarin (4)

Hematology

PROC

Protein C deficient

Warnings and Precautions

 

* Therapeutic areas do not necessarily reflect the CDER review division.
† Standard nomenclature is used for genes as per the Human Genome Organization symbol, cytogenetic abnormalities as per the International System for Human Cytogenetic Nomenclature, or other conventions.
‡ Common terminology generally used, labeling language may differ.

 

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