Drugs

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 - 1.54MB)

Pharmacogenomic Biomarkers in Drug Labeling

DrugTherapeutic Area*BiomarkerLabeling Sections
AbacavirInfectious DiseasesHLA-BBoxed Warning, Dosage and Administration, Contraindications, Warnings and Precautions
Abemaciclib (1)OncologyESR
(Hormone Receptor)
Indications and Usage, Adverse Reactions, Clinical Studies
Abemaciclib (2)OncologyERBB2
(HER2)
Indications and Usage, Adverse Reactions, Clinical Studies
Ado-Trastuzumab EmtansineOncologyERBB2
(HER2)
Indications and Usage, Warnings and Precautions, Adverse Reactions, Clinical Pharmacology, Clinical Studies
AfatinibOncologyEGFRIndications and Usage, Dosage and Administration, Adverse Reactions, Clinical Studies
AlectinibOncologyALKIndications and Usage, Dosage and Administration, Adverse Reactions, Clinical Pharmacology, Clinical Studies
AmitriptylinePsychiatryCYP2D6Precautions
AnastrozoleOncologyESR, PGR
(Hormone Receptor)
Indications and Usage, Adverse Reactions, Drug Interactions, Clinical Studies
Arformoterol (1)PulmonaryUGT1A1Clinical Pharmacology
Arformoterol (2)PulmonaryCYP2D6Clinical Pharmacology
AripiprazolePsychiatryCYP2D6Dosage and Administration, Use in Specific Populations, Clinical Pharmacology
Aripiprazole LauroxilPsychiatryCYP2D6Dosage and Administration, Use in Specific Populations, Clinical Pharmacology
Arsenic TrioxideOncologyPML-RARAIndications and Usage
AtezolizumabOncologyCD274
(PD-L1)
Adverse Reactions, Clinical Pharmacology, Clinical Studies
AtomoxetinePsychiatryCYP2D6Dosage and Administration, Warnings and Precautions, Adverse Reactions, Drug Interactions, Clinical Pharmacology
Ascorbic Acid, PEG-3350, Potassium Chloride, Sodium Ascorbate, Sodium Chloride, and Sodium SulfateGastroenterologyG6PDWarnings and Precautions
AvelumabOncologyCD274
(PD-L1)
Clinical Studies
AzathioprineRheumatologyTPMTDosage and Administration,  Warnings, Precautions, Drug Interactions, Adverse Reactions, Clinical Pharmacology
BelinostatOncologyUGT1A1Dosage and Administration, Clinical Pharmacology
BlinatumomabOncologyBCR-ABL1
(Philadelphia chromosome)
Indications and Usage, Clinical Studies
BoceprevirInfectious DiseasesIFNL3
(IL28B)
Clinical Pharmacology
BosutinibOncologyBCR-ABL1
(Philadelphia chromosome)
Indications and Usage, Adverse Reactions, Use in Specific Populations, Clinical Studies
Brentuximab VedotinOncologyALKClinical Studies
BrexpiprazolePsychiatryCYP2D6Dosage and Administration, Use in Specific Populations, Clinical Pharmacology
BrigatinibOncologyALKIndications and Usage, Adverse Reactions, Clinical Studies
BrivaracetamNeurologyCYP2C19Clinical Pharmacology
BusulfanOncologyBCR-ABL1
(Philadelphia chromosome)
Clinical Studies
CabozantinibOncologyRETClinical Studies
CapecitabineOncologyDPYDWarnings and Precautions, Patient Counseling Information
Carbamazepine (1)NeurologyHLA-BBoxed Warning, Warnings, Precautions
Carbamazepine (2)NeurologyHLA-AWarnings
Carglumic AcidInborn Errors of MetabolismNAGSIndications and Usage, Warnings and Precautions, Use in Specific Populations, Clinical Pharmacology, Clinical Studies
CariprazinePsychiatryCYP2D6Clinical Pharmacology
CarisoprodolRheumatologyCYP2C19Use in Specific Populations, Clinical Pharmacology
CarvedilolCardiologyCYP2D6Drug Interactions, Clinical Pharmacology
CelecoxibRheumatologyCYP2C9Dosage and Administration, Use in Specific Populations, Clinical Pharmacology
CeritinibOncologyALKIndications and Usage, Dosage and Administration, Adverse Reactions, Clinical Studies
Cerliponase AlfaInborn Errors of MetabolismTPP1Indications and Usage, Use in Specific Populations, Clinical Studies
Cetuximab (1)OncologyEGFRIndications and Usage, Dosage and Administration, Warnings and Precautions, Adverse Reactions, Clinical Studies
Cetuximab (2)OncologyRASIndications and Usage, Dosage and Administration, Warnings and Precautions, Adverse Reactions, Clinical Studies
CevimelineDentalCYP2D6Precautions
ChloroquineInfectious DiseasesG6PDPrecautions
ChlorpropamideEndocrinologyG6PDPrecautions
CisplatinOncologyTPMTAdverse Reactions
Citalopram (1)PsychiatryCYP2C19Dosage and Administration, Warnings, Clinical Pharmacology
Citalopram (2)PsychiatryCYP2D6Clinical Pharmacology
ClobazamNeurologyCYP2C19Dosage and Administration, Use in Specific Populations, Clinical Pharmacology
ClomipraminePsychiatryCYP2D6Precautions
ClopidogrelCardiologyCYP2C19Boxed Warning, Warnings and Precautions, Clinical Pharmacology
ClozapinePsychiatryCYP2D6Dosage and Administration, Use in Specific Populations, Clinical Pharmacology
CobimetinibOncologyBRAFIndications and Usage, Dosage and Administration, Adverse Reactions, Clinical Studies
CodeineAnesthesiologyCYP2D6Boxed Warning, Warnings and Precautions, Use in Specific Populations, Patient Counseling Information
Crizotinib (1)OncologyALKIndications and Usage, Dosage and Administration, Adverse Reactions, Use in Specific Populations, Clinical Pharmacology, Clinical Studies
Crizotinib (2)OncologyROS1Indications and Usage, Dosage and Administration, Adverse Reactions, Use in Specific Populations, Clinical Studies
Dabrafenib (1)OncologyBRAFIndications and Usage, Dosage and Administration, Warnings and Precautions, Adverse Reactions, Clinical Pharmacology, Clinical Studies, Patient Counseling Information
Dabrafenib (2)OncologyG6PDWarnings and Precautions, Adverse Reactions, Patient Counseling Information
Dabrafenib (3)OncologyRASDosage and Administration, Warnings and Precautions
DaclatasvirInfectious DiseasesIFNL3
(IL28B)
Clinical Studies
Dapsone (1)DermatologyG6PDWarnings and Precautions, Use in Specific Populations
Dapsone (2)DermatologyNonspecific
(Congenital  Methemoglobinemia)
Warnings and Precautions
Dapsone (3)Infectious DiseasesG6PDPrecautions, Adverse Reactions, Overdosage
DarifenacinUrologyCYP2D6Clinical Pharmacology
Dasabuvir, Ombitasvir, Paritaprevir, and RitonavirInfectious DiseasesIFNL3
(IL28B)
Clinical Studies
DasatinibOncologyBCR-ABL1
(Philadelphia chromosome)
Indications and Usage, Dosage and Administration, Warnings and Precautions, Adverse Reactions, Clinical Studies
Denileukin DiftitoxOncologyIL2RA
(CD25 antigen)
Indications and Usage, Warnings and Precautions, Clinical Studies
DesipraminePsychiatryCYP2D6Precautions
DesfluraneAnesthesiologyNonspecific
(Genetic Susceptibility to Malignant Hyperthermia)
Contraindications
DesvenlafaxinePsychiatryCYP2D6Clinical Pharmacology
DeutetrabenazineNeurologyCYP2D6Dosage and Administration, Warnings and Precautions, Use in Specific Populations, Clinical Pharmacology
DexlansoprazoleGastroenterologyCYP2C19Drug Interactions, Clinical Pharmacology
Dextromethorphan and QuinidineNeurologyCYP2D6Warnings and Precautions, Clinical Pharmacology
DiazepamNeurologyCYP2C19Clinical Pharmacology
DinutuximabOncologyMYCNClinical Studies
DolutegravirInfectious DiseasesUGT1A1Clinical Pharmacology
Doxepin (1)PsychiatryCYP2D6Clinical Pharmacology
Doxepin (2)PsychiatryCYP2C19Clinical Pharmacology
DronabinolGastroenterologyCYP2C9Use in Specific Populations, Clinical Pharmacology
Drospirenone and Ethinyl EstradiolGynecologyCYP2C19Clinical Pharmacology
DuloxetinePsychiatryCYP2D6Drug Interactions
DurvalumabOncologyCD274
(PD-L1)
Clinical Pharmacology, Clinical Studies
EfavirenzInfectious DiseasesCYP2B6Clinical Pharmacology
Elbasvir and GrazoprevirInfectious DiseasesIFNL3
(IL28B)
Clinical Studies
EliglustatInborn Errors of MetabolismCYP2D6Indications and Usage, Dosage and Administration, Contraindications, Warnings and Precautions, Drug Interactions, Use in Specific Populations, Clinical Pharmacology, Clinical Studies
ElosulfaseInborn Errors of MetabolismGALNSIndications and Usage, Warnings and Precautions, Use in Specific Populations, Clinical Pharmacology, Clinical Studies
Eltrombopag (1)HematologyF5
(Factor V Leiden)
Warnings and Precautions
Eltrombopag (2)HematologySERPINC1
(Antithrombin III)
Warnings and Precautions
EnasidenibOncologyIDH2Indications and Usage, Dosage and Administration, Clinical Pharmacology, Clinical Studies
Enflurane AnesthesiologyNonspecific
(Genetic Susceptibility to Malignant Hyperthermia)
Contraindications
ErlotinibOncologyEGFRIndications and Usage, Dosage and Administration, Adverse Reactions, Clinical Studies
Erythromycin and SulfisoxazoleInfectious DiseasesG6PDPrecautions
Escitalopram (1)PsychiatryCYP2D6Drug Interactions
Escitalopram (2)PsychiatryCYP2C19Adverse Reactions
EsomeprazoleGastroenterologyCYP2C19Drug Interactions, Clinical Pharmacology
EteplirsenNeurologyDMDIndications and Usage, Adverse Reactions, Use in Specific Populations, Clinical Studies
Everolimus (1)OncologyERBB2
(HER2)
Indications and Usage, Dosage and Administration, Warnings and Precautions, Adverse Reactions, Drug Interactions, Use in Specific Populations, Clinical Studies
Everolimus (2)OncologyESR
(Hormone Receptor)
Indications and Usage, Dosage and Administration, Warnings and Precautions, Adverse Reactions, Drug Interactions, Use in Specific Populations, Clinical Studies
ExemestaneOncologyESR, PGR
(Hormone Receptor)
Indications and Usage, Dosage and Administration, Clinical Studies
FesoterodineUrologyCYP2D6Drug Interactions, Clinical Pharmacology
Flibanserin (1)GynecologyCYP2C9Clinical Pharmacology
Flibanserin (2)GynecologyCYP2C19Adverse Reactions, Use in Specific Populations, Clinical Pharmacology
Flibanserin (3)GynecologyCYP2D6Clinical Pharmacology
Fluorouracil (1)DermatologyDPYDContraindications, Warnings
Fluorouracil (2)OncologyDPYDWarnings and Precautions, Patient Counseling Information
FluoxetinePsychiatryCYP2D6Precautions, Clinical Pharmacology
FlurbiprofenRheumatologyCYP2C9Clinical Pharmacology
FluvoxaminePsychiatryCYP2D6Drug Interactions
Formoterol (1)PulmonaryCYP2D6Clinical Pharmacology
Formoterol (2)PulmonaryCYP2C19Clinical Pharmacology
Fulvestrant (1)OncologyERBB2
(HER2)
Indications and Usage, Adverse Reactions, Clinical Studies
Fulvestrant (2)OncologyESR, PGR
(Hormone Receptor)
Indications and Usage, Adverse Reactions, Clinical Pharmacology, Clinical Studies
GalantamineNeurologyCYP2D6Clinical Pharmacology
GefitinibOncologyEGFRIndications and Usage, Dosage and Administration, Clinical Studies
GlimepirideEndocrinologyG6PDWarnings and Precautions, Adverse Reactions
GlipizideEndocrinologyG6PDPrecautions
GlyburideEndocrinologyG6PDPrecautions
HydralazineCardiologyNonspecific
(NAT)
Clinical Pharmacology
Ibrutinib (1)OncologyChromosome 17pIndications and Usage, Clinical Studies
Ibrutinib (2)OncologyChromosome 11qClinical Studies
IloperidonePsychiatryCYP2D6Dosage and Administration, Warnings and Precautions, Drug Interactions, Clinical Pharmacology
Imatinib (1)OncologyKITIndications and Usage, Dosage and Administration, Clinical Studies
Imatinib (2)OncologyBCR-ABL1
(Philadelphia chromosome)
Indications and Usage, Dosage and Administration, Warnings and Precautions, Adverse Reactions, Use in Specific Populations, Clinical Pharmacology, Clinical Studies
Imatinib (3)OncologyPDGFRBIndications and Usage, Dosage and Administration, Clinical Studies
Imatinib (4)OncologyFIP1L1-PDGFRAIndications and Usage, Dosage and Administration, Clinical Studies
ImipraminePsychiatryCYP2D6Precautions
IndacaterolPulmonaryUGT1A1Clinical Pharmacology
Inotuzumab OzogamicinOncologyBCR-ABL1
(Philadelphia chromosome)
Clinical Studies
IrinotecanOncologyUGT1A1Dosage and Administration, Warnings and Precautions, Clinical Pharmacology
IsofluraneAnesthesiologyNonspecific
(Genetic Susceptibility to Malignant Hyperthermia)
Contraindications
Isoniazid, Pyrazinamide, and RifampinInfectious DiseasesNonspecific
(NAT)
Clinical Pharmacology
Isosorbide DinitrateCardiologyCYB5ROverdosage
Isosorbide MononitrateCardiologyCYB5ROverdosage
IvacaftorPulmonaryCFTRIndications and Usage, Adverse Reactions, Use in Specific Populations, Clinical Pharmacology, Clinical Studies
Ivacaftor and LumacaftorPulmonaryCFTRIndications and Usage, Adverse Reactions, Use in Specific Populations, Clinical Studies
LacosamideNeurologyCYP2C19Clinical Pharmacology
LansoprazoleGastroenterologyCYP2C19Drug Interactions, Clinical Pharmacology
Lapatinib (1)OncologyERBB2
(HER2)
Indications and Usage, Dosage and Administration, Adverse Reactions, Use in Specific Populations, Clinical Studies
Lapatinib (2)OncologyESR, PGR
(Hormone Receptor)
Indications and Usage, Dosage and Administration, Adverse Reactions, Use in Specific Populations, Clinical Studies
Lapatinib (3)OncologyHLA-DQA1, HLA-DRB1Clinical Pharmacology
Ledipasvir and SofosbuvirInfectious DiseasesIFNL3
(IL28B)
Clinical Studies
LenalidomideHematologyChromosome 5qBoxed Warning, Indications and Usage, Adverse Reactions, Use in Specific Populations, Clinical Studies
LesinuradRheumatologyCYP2C9Drug Interactions, Clinical Pharmacology
LetrozoleOncologyESR, PGR
(Hormone Receptor)
Indications and Usage, Adverse Reactions, Clinical Studies
Lidocaine and Prilocaine (1)AnesthesiologyNonspecific
(Congenital  Methemoglobinemia)
Warnings and Precautions
Lidocaine and Prilocaine (2)AnesthesiologyG6PDWarnings and Precautions, Clinical Pharmacology
MafenideInfectious DiseasesG6PDWarnings, Adverse Reactions
MercaptopurineOncologyTPMTDosage and Administration, Warnings, Precautions, Adverse Reactions, Clinical Pharmacology
Methylene BlueHematologyG6PDContraindications, Warnings and Precautions
Metoclopramide (1)GastroenterologyCYB5RPrecautions, Overdosage
Metoclopramide (2)GastroenterologyG6PDPrecautions, Overdosage
MetoprololCardiologyCYP2D6Drug Interactions, Clinical Pharmacology
Midostaurin (1)OncologyFLT3Indications and Usage, Dosage and Administration, Adverse Reactions, Clinical Studies
Midostaurin (2) OncologyNPM1Clinical Studies
Midostaurin (3) OncologyKITClinical Studies
MirabegronUrologyCYP2D6Clinical Pharmacology
ModafinilPsychiatryCYP2D6Clinical Pharmacology
Mycophenolic AcidTransplantationHPRT1Warnings and Precautions
Nalidixic AcidInfectious DiseasesG6PDPrecautions, Adverse Reactions
NebivololCardiologyCYP2D6Dosage and Administration, Clinical Pharmacology
NefazodonePsychiatryCYP2D6Precautions
Neratinib (1)OncologyERBB2
(HER2)

Indications and Usage, Adverse Reactions, Clinical Studies

Neratinib (2)OncologyESR, PGR
(Hormone Receptor)

Clinical Studies

Nilotinib (1)OncologyBCR-ABL1
(Philadelphia chromosome)
Indications and Usage, Dosage and Administration, Warnings and Precautions, Adverse Reactions, Use in Specific Populations, Clinical Studies
Nilotinib (2)OncologyUGT1A1Clinical Pharmacology
NiraparibOncologyBRCAClinical Studies
NitrofurantoinInfectious DiseasesG6PDWarnings, Adverse Reactions
Nivolumab (1)OncologyBRAFIndications and Usage, Adverse Reactions, Clinical Studies
Nivolumab (2)OncologyCD274
(PD-L1)
Clinical Pharmacology, Clinical Studies
Nivolumab (3)OncologyMicrosatellite Instability, Mismatch RepairIndications and Usage, Use in Specific Populations, Clinical Pharmacology, Clinical Studies
NortriptylinePsychiatryCYP2D6Precautions
ObinutuzumabOncologyMS4A1
(CD20 antigen)
Clinical Studies
OlaparibOncologyBRCAIndications and Usage, Dosage and Administration, Warnings and Precautions, Adverse Reactions, Clinical Studies
OlaratumabOncologyPDGFRAClinical Studies
OmacetaxineOncologyBCR-ABL1
(Philadelphia chromosome)
Clinical Studies
Ombitasvir, Paritaprevir, and RitonavirInfectious DiseasesIFNL3
(IL28B)
Clinical Studies
OmeprazoleGastroenterologyCYP2C19Drug Interactions, Clinical Pharmacology
OndansetronGastroenterologyCYP2D6Clinical Pharmacology
OsimertinibOncologyEGFRIndications and Usage, Dosage and Administration, Warnings and Precautions, Adverse Reactions, Clinical Studies
OxcarbazepineNeurologyHLA-BWarnings and Precautions
Palbociclib (1)OncologyESR
(Hormone Receptor)
Indications and Usage, Adverse Reactions, Clinical Studies
Palbociclib (2)OncologyERBB2
(HER2)
Indications and Usage, Adverse Reactions, Clinical Studies
PalonosetronGastroenterologyCYP2D6Clinical Pharmacology
Panitumumab (1)OncologyEGFRAdverse Reactions, Clinical Pharmacology, Clinical Studies
Panitumumab (2)OncologyRASIndications and Usage, Dosage and Administration, Warnings and Precautions, Adverse Reactions, Clinical Studies
PantoprazoleGastroenterologyCYP2C19Clinical Pharmacology
Parathyroid HormoneInborn Errors of MetabolismCASRIndications and Usage, Clinical Studies
ParoxetinePsychiatryCYP2D6Drug Interactions
Pazopanib (1)OncologyUGT1A1Clinical Pharmacology
Pazopanib (2)OncologyHLA-BClinical Pharmacology
Peginterferon Alfa-2bInfectious DiseasesIFNL3
(IL28B)
Clinical Pharmacology
PegloticaseRheumatologyG6PDBoxed Warning, Contraindications, Warnings and Precautions, Patient Counseling Information
Pembrolizumab (1)OncologyBRAFAdverse Reactions, Clinical Studies
Pembrolizumab (2)OncologyCD274
(PD-L1)
Indications and Usage, Dosage and Administration, Use in Specific Populations, Clinical Studies
Pembrolizumab (3) OncologyMicrosatellite Instability, Mismatch RepairIndications and Usage,
Dosage and Administration, Use in Specific Populations, Clinical Studies 
PerphenazinePsychiatryCYP2D6Precautions, Clinical Pharmacology
Pertuzumab (1)OncologyERBB2
(HER2)
Indications and Usage, Warnings and Precautions, Adverse Reactions, Clinical Pharmacology, Clinical Studies
Pertuzumab (2)OncologyESR, PGR
(Hormone Receptor)
Clinical Studies
Phenytoin (1)NeurologyCYP2C9Clinical Pharmacology
Phenytoin (2)NeurologyCYP2C19Clinical Pharmacology
Phenytoin (3)NeurologyHLA-BWarnings
PimozidePsychiatryCYP2D6Dosage and Administration, Precautions
PiroxicamRheumatologyCYP2C9Clinical Pharmacology
PonatinibOncologyBCR-ABL1
(Philadelphia chromosome)
Indications and Usage, Warnings and Precautions, Adverse Reactions, Use in Specific Populations, Clinical Studies
Prasugrel (1)CardiologyCYP2C19Use in Specific Populations, Clinical Pharmacology, Clinical Studies
Prasugrel (2)CardiologyCYP2C9Use in Specific Populations, Clinical Pharmacology, Clinical Studies
Prasugrel (3)CardiologyCYP3A5Use in Specific Populations, Clinical Pharmacology, Clinical Studies
Prasugrel (4)CardiologyCYP2B6Use in Specific Populations, Clinical Pharmacology, Clinical Studies
Primaquine (1)Infectious DiseasesG6PDContraindications, Warnings, Precautions, Adverse Reactions, Overdosage
Primaquine (2) Infectious DiseasesCYB5RPrecautions, Adverse Reactions
PropafenoneCardiologyCYP2D6Dosage and Administration, Warnings and Precautions, Drug Interactions, Clinical Pharmacology
PropranololCardiologyCYP2D6Clinical Pharmacology
ProtriptylinePsychiatryCYP2D6Precautions
QuinidineCardiologyCYP2D6Precautions
Quinine Sulfate (1)Infectious DiseasesG6PDContraindications
Quinine Sulfate (2)Infectious DiseasesCYP2D6Drug Interactions
RabeprazoleGastroenterologyCYP2C19Clinical Pharmacology
Rasburicase (1)OncologyG6PDBoxed Warning, Contraindications, Warnings and Precautions
Rasburicase (2)OncologyCYB5RBoxed Warning, Contraindications, Warnings and Precautions
Ribociclib (1)OncologyESR, PGR
(Hormone Receptor)
Indications and Usage, Clinical Studies
Ribociclib (2)OncologyERBB2
(HER2)
Indications and Usage, Clinical Studies
RisperidonePsychiatryCYP2D6Drug Interactions, Clinical Pharmacology
RituximabOncologyMS4A1
(CD20 antigen)
Indications and Usage, Dosage and Administration, Adverse Reactions, Use in Specific Populations, Clinical Studies
RosuvastatinEndocrinologySLCO1B1Clinical Pharmacology
Rucaparib (1)OncologyBRCAIndications and Usage, Dosage and Administration, Adverse Reactions, Use in Specific Populations, Clinical Studies
Rucaparib (2)OncologyCYP2D6Clinical Pharmacology
Rucaparib (3)OncologyCYP1A2Clinical Pharmacology
SevofluraneAnesthesiologyNonspecific
(Genetic Susceptibility to Malignant Hyperthermia)
Warnings
SimeprevirInfectious DiseasesIFNL3
(IL28B)
Clinical Pharmacology, Clinical Studies
Sodium NitriteToxicologyG6PDWarnings and Precautions
SofosbuvirInfectious DiseasesIFNL3
(IL28B)
Clinical Studies
Sofosbuvir and VelpatasvirInfectious DiseasesIFNL3
(IL28B)
Clinical Studies
Sofosbuvir, Velpatasvir, and VoxilaprevirInfectious DiseasesIFNL3
(IL28B)
Clinical Studies
SuccimerHematologyG6PDClinical Pharmacology
SuccinylcholineAnesthesiologyBCHEWarnings, Precautions
Sulfamethoxazole and Trimethoprim (1)Infectious DiseasesG6PDPrecautions
Sulfamethoxazole and Trimethoprim (2)Infectious DiseasesNonspecific
(NAT)
Precautions
Sulfasalazine (1)GastroenterologyG6PDPrecautions
Sulfasalazine (2)GastroenterologyNonspecific
(NAT)
Clinical Pharmacology
Tamoxifen (1)OncologyESR, PGR
(Hormone Receptor)
Indications and Usage, Precautions, Adverse Reactions, Clinical Studies
Tamoxifen (2)OncologyF5
(Factor V Leiden)
Warnings
Tamoxifen (3)OncologyF2
(Prothrombin)
Warnings
TelaprevirInfectious DiseasesIFNL3
(IL28B)
Clinical Pharmacology, Clinical Studies
TetrabenazineNeurologyCYP2D6Dosage and Administration, Warnings and Precautions, Use in Specific Populations, Clinical Pharmacology
ThioguanineOncologyTPMTDosage and Administration, Warnings, Precautions
ThioridazinePsychiatryCYP2D6Contraindications, Warnings, Precautions
TicagrelorCardiologyCYP2C19Clinical Pharmacology
TolterodineUrologyCYP2D6Precautions, Clinical Pharmacology
TramadolAnesthesiologyCYP2D6Boxed Warning, Warnings, Precautions, Use in Specific Populations, Clinical Pharmacology
Trametinib (1)OncologyBRAFIndications and Usage, Dosage and Administration, Adverse Reactions, Clinical Pharmacology, Clinical Studies, Patient Counseling Information
Trametinib (2)OncologyG6PDAdverse Reactions
Trametinib (3)OncologyRASWarnings and Precautions
Trastuzumab (1)OncologyERBB2
(HER2)
Indications and Usage, Warnings and Precautions, Clinical Pharmacology, Clinical Studies
Trastuzumab (2)OncologyESR, PGR
(Hormone Receptor)
Clinical Studies
TretinoinOncologyPML-RARAIndications and Usage, Warnings, Clinical Pharmacology
TrimipraminePsychiatryCYP2D6Precautions
UmeclidiniumPulmonaryCYP2D6Clinical Pharmacology
UstekinumabDermatology and GastroenterologyIL12A, IL12B, IL23AWarnings and Precautions
ValbenazineNeurologyCYP2D6Dosage and Administration, Warnings and Precautions, Use in Specific Populations, Clinical Pharmacology
Valproic Acid (1)NeurologyPOLGBoxed Warning, Contraindications, Warnings and Precautions
Valproic Acid (2)NeurologyNonspecific
(Urea Cycle Disorders)
Contraindications, Warnings and Precautions
Vemurafenib (1)OncologyBRAFIndications and Usage, Dosage and Administration, Warnings and Precautions, Adverse Reactions, Use in Specific Populations, Clinical Pharmacology, Clinical Studies, Patient Counseling Information
Vemurafenib (2)OncologyRASWarnings and Precautions, Adverse Reactions
VenlafaxinePsychiatryCYP2D6Precautions
VenetoclaxOncologyChromosome 17pIndications and Usage, Dosage and Administration, Use in Specific Populations, Clinical Studies
VoriconazoleInfectious DiseasesCYP2C19Clinical Pharmacology
VortioxetinePsychiatryCYP2D6Dosage and Administration, Clinical Pharmacology
Warfarin (1)HematologyCYP2C9Dosage and Administration, Drug Interactions, Clinical Pharmacology
Warfarin (2)HematologyVKORC1Dosage and Administration, Clinical Pharmacology
Warfarin (3)HematologyPROS1Warnings and Precautions
Warfarin (4)HematologyPROCWarnings 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.

 

 

 

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