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
  • Trial design features

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 (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-B*57:01Boxed Warning, Dosage and Administration, Contraindications, Warnings and Precautions
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, Adverse Reactions, Clinical Pharmacology, Clinical Studies
AlirocumabEndocrinologyNot specifiedIndications and Usage, Adverse Reactions, Clinical Studies
AmitriptylinePsychiatryCYP2D6Precautions
AnastrozoleOncologyESR1, PGRIndications 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
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
BrivaracetamNeurologyCYP2C19Clinical Pharmacology
BusulfanOncologyBCR-ABL1 (Philadelphia chromosome)Clinical Studies
CabozantinibOncologyRETClinical Studies
CapecitabineOncologyDPYDWarnings and Precautions, Patient Counseling Information
Carbamazepine (1)NeurologyHLA-B*15:02Boxed Warning, Warnings, Precautions
Carbamazepine (2)NeurologyHLA-A*31:01Warnings
Carglumic AcidInborn Errors of MetabolismNAGSIndications and Usage, Warnings and Precautions, Use in Specific Populations, Clinical Pharmacology, Clinical Studies
CarisoprodolRheumatologyCYP2C19Use in Specific Populations, Clinical Pharmacology
CarvedilolCardiologyCYP2D6Drug Interactions, Clinical Pharmacology
CelecoxibRheumatologyCYP2C9Dosage and Administration, Use in Specific Populations, Clinical Pharmacology
CeritinibOncologyALKIndications and Usage, Adverse Reactions, Clinical Pharmacology, Clinical Studies
Cetuximab (1)OncologyEGFRIndications and Usage, Dosage and Administration, Warnings and Precautions, Adverse Reactions, Clinical Studies
Cetuximab (2)OncologyKRAS, NRAS (RAS)Indications 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)OncologyHRAS, KRAS, NRAS (RAS)Dosage and Administration, Warnings and Precautions
DaclatasvirInfectious DiseasesIFNL3 (IL28B)Clinical Studies
Dapsone (1)DermatologyG6PDWarnings and Precautions, Use in Specific Populations
Dapsone (2)DermatologyNot specifiedWarnings and Precautions
Dapsone (3)Infectious DiseasesG6PDPrecautions, Adverse Reactions, Overdosage
DarifenacinUrologyCYP2D6Clinical Pharmacology
Dasabuvir, Ombitasvir, Paritaprevir, and RitonavirInfectious DiseasesIFNL3 (IL28B)Clinical Studies
DasatinibOncologyBCR-ABL1 (Philadelphia chromosome); T315I mutationIndications 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
DesfluraneAnesthesiologyNot specifiedContraindications
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
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
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)OncologyESR1Indications and Usage, Dosage and Administration, Warnings and Precautions, Adverse Reactions, Drug Interactions, Use in Specific Populations, Clinical Studies
EvolocumabEndocrinologyNot specifiedIndications and Usage, Dosage and Administration, Adverse Reactions, Use in Specific Populations, Clinical Studies
ExemestaneOncologyESR1, PGRIndications 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
Fulvestrant (1)OncologyERBB2 (HER2)Indications and Usage, Adverse Reactions, Clinical Studies
Fulvestrant (2)OncologyESR1, PGRIndications 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
HydralazineCardiologyNAT1, NAT2Clinical Pharmacology
IbrutinibOncologydel (17p)Indications and Usage, Clinical 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
IrinotecanOncologyUGT1A1Dosage and Administration, Warnings and Precautions, Clinical Pharmacology
IsofluraneAnesthesiologyNot specifiedContraindications
Isoniazid, Pyrazinamide, and RifampinInfectious DiseasesNAT1, NAT2Clinical Pharmacology
Isosorbide DinitrateCardiologyCYB5R1, CYB5R2, CYB5R3, CYB5R4Overdosage
Isosorbide MononitrateCardiologyCYB5R1, CYB5R2, CYB5R3, CYB5R4Overdosage
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)OncologyESR1, PGRIndications and Usage, Dosage and Administration, Adverse Reactions, Use in Specific Populations, Clinical Studies
Lapatinib (3)OncologyHLA-DQA1*02:01, HLA-DRB1*07:01Clinical Pharmacology
Ledipasvir and SofosbuvirInfectious DiseasesIFNL3 (IL28B)Clinical Studies
LenalidomideHematologydel (5q)Boxed Warning, Indications and Usage, Adverse Reactions, Use in Specific Populations, Clinical Studies
LesinuradRheumatologyCYP2C9Drug Interactions, Clinical Pharmacology
LetrozoleOncologyESR1, PGRIndications and Usage, Adverse Reactions, Clinical Studies
Lidocaine and Prilocaine (1)AnesthesiologyNot specifiedWarnings and Precautions
Lidocaine and Prilocaine (2)AnesthesiologyG6PDWarnings and Precautions, Clinical Pharmacology
LomitapideEndocrinologyNot specifiedBoxed Warning, Indication and Usage, Warnings and Precautions, Adverse Reactions, Clinical Studies
MafenideInfectious DiseasesG6PDWarnings, Adverse Reactions
MercaptopurineOncologyTPMTDosage and Administration, Warnings, Precautions, Adverse Reactions, Clinical Pharmacology
Methylene BlueHematologyG6PDContraindications, Warnings and Precautions
Metoclopramide (1)GastroenterologyCYB5R1, CYB5R2, CYB5R3, CYB5R4Precautions, Overdosage
Metoclopramide (2)GastroenterologyG6PDPrecautions, Overdosage
MetoprololCardiologyCYP2D6Drug Interactions, Clinical Pharmacology
MipomersenEndocrinologyNot specifiedBoxed Warning, Indications and Usage, Warnings and Precautions, Adverse Reactions, Use in Specific Populations, Clinical Studies
ModafinilPsychiatryCYP2D6Clinical Pharmacology
Mycophenolic AcidTransplantationHPRT1Warnings and Precautions
Nalidixic AcidInfectious DiseasesG6PDPrecautions, Adverse Reactions
NebivololCardiologyCYP2D6Dosage and Administration, Clinical Pharmacology
NefazodonePsychiatryCYP2D6Precautions
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
NitrofurantoinInfectious DiseasesG6PDWarnings, Adverse Reactions
NivolumabOncologyBRAFIndications and Usage, Adverse Reactions, Clinical Studies
NortriptylinePsychiatryCYP2D6Precautions
ObinutuzumabOncologyMS4A1 (CD20 antigen)Clinical Studies
OlaparibOncologyBRCA1, BRCA2Indications 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, Adverse Reactions, Clinical Studies
OxcarbazepineNeurologyHLA-B*15:02Warnings and Precautions
Palbociclib (1)OncologyESR1Indications 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)OncologyKRAS, NRAS (RAS)Indications 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-B*57:01Clinical Pharmacology
Peginterferon Alfa-2bInfectious DiseasesIFNL3 (IL28B)Clinical Pharmacology
PegloticaseRheumatologyG6PDBoxed Warning, Contraindications, Warnings and Precautions, Patient Counseling Information
Pembrolizumab (1)OncologyBRAFClinical Studies
Pembrolizumab (2)OncologyCD274 (PD-L1)Indications and Usage, Dosage and Administration, Clinical Studies
PerphenazinePsychiatryCYP2D6Precautions, Clinical Pharmacology
Pertuzumab (1)OncologyERBB2 (HER2)Indications and Usage, Warnings and Precautions, Adverse Reactions, Clinical Pharmacology, Clinical Studies
Pertuzumab (2)OncologyESR1, PGRClinical Studies
Phenytoin (1)NeurologyCYP2C9Clinical Pharmacology
Phenytoin (2)NeurologyCYP2C19Clinical Pharmacology
Phenytoin (3)NeurologyHLA-B*15:02Warnings
PimozidePsychiatryCYP2D6Dosage and Administration, Precautions
PiroxicamRheumatologyCYP2C9Clinical Pharmacology
PonatinibOncologyBCR-ABL1 (Philadelphia chromosome); T315I mutationIndications 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 DiseasesCYB5R1, CYB5R2, CYB5R3, CYB5R4Precautions, 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)OncologyCYB5R1, CYB5R2, CYB5R3, CYB5R4Boxed Warning, Contraindications, Warnings and Precautions
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)OncologyBRCA1, BRCA2Indications and Usage, Dosage and Administration, Adverse Reactions, Use in Specific Populations, Clinical Studies
Rucaparib (2)OncologyCYP2D6Clinical Pharmacology
Rucaparib (3)OncologyCYP1A2Clinical Pharmacology
SevofluraneAnesthesiologyRYR1Warnings
SimeprevirInfectious DiseasesIFNL3 (IL28B)Clinical Pharmacology, Clinical Studies
Sodium NitriteToxicologyG6PDWarnings and Precautions
SofosbuvirInfectious DiseasesIFNL3 (IL28B)Clinical Studies
Sofosbuvir and VelpatasvirInfectious DiseasesIFNL3 (IL28B)Clinical Studies
SuccimerHematologyG6PDClinical Pharmacology
Sulfamethoxazole and TrimethoprimInfectious DiseasesG6PDPrecautions
SulfasalazineGastroenterologyG6PDPrecautions
Tamoxifen (1)OncologyESR1, PGRIndications 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
TramadolAnesthesiologyCYP2D6Clinical Pharmacology
TrametinibOncologyBRAFIndications and Usage, Dosage and Administration, Adverse Reactions, Clinical Pharmacology, Clinical Studies, Patient Counseling Information
Trastuzumab (1)OncologyERBB2 (HER2)Indications and Usage, Warnings and Precautions, Clinical Pharmacology, Clinical Studies
Trastuzumab (2)OncologyESR1, PGRClinical Studies
TretinoinOncologyPML-RARAIndications and Usage, Warnings, Clinical Pharmacology
TrimipraminePsychiatryCYP2D6Precautions
UstekinumabDermatology and GastroenterologyIL12A, IL12B, IL23AWarnings and Precautions
Valproic Acid (1)NeurologyPOLGBoxed Warning, Contraindications, Warnings and Precautions
Valproic Acid (2)NeurologyABL2, ASL, ASS1, CPS1, NAGS, OTCContraindications, Warnings and Precautions
Vemurafenib (1)OncologyBRAFIndications and Usage, Dosage and Administration, Warnings and Precautions, Clinical Pharmacology, Clinical Studies, Patient Counseling Information
Vemurafenib (2)OncologyNRASWarnings and Precautions, Adverse Reactions
VenlafaxinePsychiatryCYP2D6Precautions
VenetoclaxOncologydel (17p)Indications 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.
† 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.

 

 

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