FDA公布的药品说明书中药物基因组学相关生物标志物列表

TableofPharmacogenomicBiomarkersinDrugLabeling

Pharmacogenomicscanplayanimportantroleinidentifyingrespondersandnon-responderstomedications,avoidingadverseevents,andoptimizingdrugdose.Druglabelingmaycontaininformationongenomicbiomarkersandcandescribe:

Drugexposureandclinicalresponsevariability

Riskforadverseevents

Genotype-specificdosing

Mechanismsofdrugaction

Polymorphicdrugtargetanddispositiongenes

ThetablebelowlistsFDA-approveddrugswithpharmacogenomicinformationintheirlabeling.Thelabelingforsome,butnotall,oftheproductsincludesspecificactionstobetakenbasedonthebiomarkerinformation.Pharmacogenomicinformationcanappearindifferentsectionsofthelabelingdependingontheactions.Formoreinformation,pleaserefertotheappropriatelabelingguidance.

Biomarkersinthetableincludebutarenotlimitedtogerm-lineorsomaticgenevariants,functionaldeficiencies,expressionchanges,andchromosomalabnormalities;selectedproteinbiomarkersthatareusedtoselectpatientsfortreatmentarealsoincluded.

Thistabledoesnotincludenon-humangeneticbiomarkers(e.g.,microbialvariantsthatinfluencesensitivitytoantibiotics),orbiomarkersthatareusedsolelyfordiagnosticpurposes(e.g.,forgeneticdiseases)unlesstheyarelinkedtodrugactivityorusedtoidentifyaspecificsubsetinwhomprescribinginformationdiffers.Fordrugsthatareavailableinmultipledosageforms,salts,orcombinations,asinglerepresentativeproductislisted.Inthecaseofcombinationproducts,thesingleagentassociatedwiththebiomarkerislistedunlesstheagentisonlyapprovedasacombinationproduct,inwhichcaseallagentsarelisted.

PharmacogenomicBiomarkersinDrugLabeling

Drug

TherapeuticArea*

Biomarker†

ReferencedSubgroup‡

LabelingSections

Abacavir

InfectiousDiseases

HLA-B

HLA-B*5701allelecarriers

BoxedWarning,Contraindications,WarningsandPrecautions

Ado-TrastuzumabEmtansine

Oncology

ERBB2

HER2proteinoverexpressionorgeneamplificationpositive

IndicationsandUsage,WarningsandPrecautions,AdverseReactions,ClinicalPharmacology,ClinicalStudies

Afatinib

Oncology

EGFR

EGFRexon19deletionorexon21substitution(L858R)positive

IndicationsandUsage,DosageandAdministration,AdverseReactions,ClinicalPharmacology,ClinicalStudies

Alectinib

Oncology

ALK

ALKgenerearrangementpositive

IndicationsandUsage,AdverseReactions,ClinicalPharmacology,ClinicalStudies

Alirocumab

Endocrinology

LDLR

LDLreceptormutationheterozygotes

IndicationsandUsage,AdverseReactions,ClinicalStudies

Amitriptyline

Psychiatry

CYP2D6

CYP2D6poormetabolizers

Precautions

Anastrozole

Oncology

ESR1,PGR

Hormonereceptorpositive

IndicationsandUsage,AdverseReactions,DrugInteractions,ClinicalStudies

Arformoterol(1)

Pulmonary

UGT1A1

UGT1A1poormetabolizers

ClinicalPharmacology

Arformoterol(2)

Pulmonary

CYP2D6

CYP2D6intermediateorpoormetabolizers

ClinicalPharmacology

Aripiprazole

Psychiatry

CYP2D6

CYP2D6poormetabolizers

DosageandAdministration,UseinSpecificPopulations,DrugInteractions,ClinicalPharmacology

AripiprazoleLauroxil

Psychiatry

CYP2D6

CYP2D6poormetabolizers

DosageandAdministration,UseinSpecificPopulations,ClinicalPharmacology

ArsenicTrioxide

Oncology

PML-RARA

PML-RARαtranslocationpositive

ClinicalPharmacology,IndicationsandUsage

Atomoxetine

Psychiatry

CYP2D6

CYP2D6poormetabolizers

DosageandAdministration,WarningsandPrecautions,DrugInteractions,ClinicalPharmacology

Azathioprine

Rheumatology

TPMT

TPMTintermediateorpoormetabolizers

ClinicalPharmacology,Warnings,Precautions,DrugInteractions,AdverseReactions,DosageandAdministration

Belinostat

Oncology

UGT1A1

UGT1A1*28allelehomozygotes

DosageandAdministration,ClinicalPharmacology

Blinatumomab

Oncology

BCR-ABL1

Philadelphiachromosomenegative

IndicationsandUsage,ClinicalStudies

Boceprevir

InfectiousDiseases

IFNL3

IL28Brs12979860Tallelecarriers(C/TandT/Tgenotype)

ClinicalPharmacology

Bosutinib

Oncology

BCR-ABL1

Philadelphiachromosomepositive

IndicationsandUsage,AdverseReactions,UseinSpecificPopulations,ClinicalStudies

Brexpiprazole

Psychiatry

CYP2D6

CYP2D6poormetabolizers

DosageandAdministration,DrugInteractions,UseinSpecificPopulations,ClinicalPharmacology

Busulfan

Oncology

BCR-ABL1

Philadelphiachromosomenegative

ClinicalStudies

Cabozantinib

Oncology

RET

RETmutationpositive

ClinicalStudies

Capecitabine

Oncology

DPYD

DPDdeficient

WarningsandPrecautions,PatientCounselingInformation

Carbamazepine(1)

Neurology

HLA-B

HLA-B*1502allelecarriers

BoxedWarning,Warnings,Precautions

Carbamazepine(2)

Neurology

HLA-A

HLA-A*3101allelecarriers

Warnings

CarglumicAcid

InbornErrorsofMetabolism

NAGS

N-acetylglutamatesynthasedeficient

IndicationsandUsage,WarningsandPrecautions,UseinSpecificPopulations,ClinicalPharmacology,ClinicalStudies

Carisoprodol

Rheumatology

CYP2C19

CYP2C19poormetabolizers

UseinSpecificPopulations,ClinicalPharmacology

Carvedilol

Cardiology

CYP2D6

CYP2D6poormetabolizers

DrugInteractions,ClinicalPharmacology

Celecoxib

Rheumatology

CYP2C9

CYP2C9poormetabolizers

DosageandAdministration,UseinSpecificPopulations,ClinicalPharmacology

Ceritinib

Oncology

ALK

ALKgenerearrangementpositive

IndicationsandUsage,AdverseReactions,ClinicalPharmacology,ClinicalStudies

Cetuximab(1)

Oncology

EGFR

EGFRproteinexpressionpositive

IndicationsandUsage,DosageandAdministration,WarningsandPrecautions,AdverseReactions,ClinicalPharmacology,ClinicalStudies

Cetuximab(2)

Oncology

KRAS

KRAScodon12and13mutationnegative

IndicationsandUsage,DosageandAdministration,WarningsandPrecautions,AdverseReactions,ClinicalPharmacology,ClinicalStudies

Cevimeline

Dental

CYP2D6

CYP2D6poormetabolizers

Precautions

Chloroquine

InfectiousDiseases

G6PD

G6PDdeficient

Precautions

Chlorpropamide

Endocrinology

G6PD

G6PDdeficient

Precautions

CholicAcid

InbornErrorsofMetabolism

AKR1D1,HSD3B7,CYP27A1,AMACR,CYP7A1

Bileacidsynthesisenzymedeficient

IndicationsandUsage,WarningsandPrecautions,AdverseReactions,UseinSpecificPopulations,ClinicalPharmacology,ClinicalStudies

Cisplatin

Oncology

TPMT

TPMTintermediateorpoormetabolizers

AdverseReactions

Citalopram(1)

Psychiatry

CYP2C19

CYP2C19poormetabolizers

ClinicalPharmacology,Warnings,DosageandAdministration

Citalopram(2)

Psychiatry

CYP2D6

CYP2D6poormetabolizers

ClinicalPharmacology

Clobazam

Neurology

CYP2C19

CYP2C19poormetabolizers

DosageandAdministration,UseinSpecificPopulations,ClinicalPharmacology

Clomipramine

Psychiatry

CYP2D6

CYP2D6poormetabolizers

Precautions

Clopidogrel

Cardiology

CYP2C19

CYP2C19intermediateorpoormetabolizers

BoxedWarning,DosageandAdministration,WarningsandPrecautions,ClinicalPharmacology

Clozapine

Psychiatry

CYP2D6

CYP2D6poormetabolizers

DosageandAdministration,UseinSpecificPopulations,ClinicalPharmacology

Cobimetinib

Oncology

BRAF

BRAFV600E/Kmutationpositive

IndicationsandUsage,DosageandAdministration,AdverseReactions,ClinicalPharmacology,ClinicalStudies

Codeine

Anesthesiology

CYP2D6

CYP2D6ultrarapidmetabolizers

BoxedWarning,WarningsandPrecautions,UseinSpecificPopulations,PatientCounselingInformation

Crizotinib

Oncology

ALK

ALKgenerearrangementpositive

IndicationsandUsage,DosageandAdministration,AdverseReactions,ClinicalPharmacology,ClinicalStudies

Dabrafenib(1)

Oncology

BRAF

BRAFV600E/Kmutationpositive

IndicationsandUsage,DosageandAdministration,WarningsandPrecautions,AdverseReactions,ClinicalPharmacology,ClinicalStudies,PatientCounselingInformation

Dabrafenib(2)

Oncology

G6PD

G6PDdeficient

WarningsandPrecautions,AdverseReactions,PatientCounselingInformation

Dapsone(1)

Dermatology

G6PD

G6PDdeficient

WarningsandPrecautions,UseinSpecificPopulations,PatientCounselingInformation

Dapsone(2)

InfectiousDiseases

G6PD

G6PDdeficient

Precautions,AdverseReactions,Overdosage

Dasatinib

Oncology

BCR-ABL1

Philadelphiachromosomepositive,T315Imutationpositive

IndicationsandUsage,DosageandAdministration,WarningsandPrecautions,AdverseReactions,ClinicalPharmacology,ClinicalStudies

DenileukinDiftitox

Oncology

IL2RA

CD25antigenpositive

IndicationsandUsage,WarningsandPrecautions,ClinicalStudies

Desipramine

Psychiatry

CYP2D6

CYP2D6poormetabolizers

Precautions

Dexlansoprazole

Gastroenterology

CYP2C19

CYP2C19poormetabolizers

DrugInteractions,ClinicalPharmacology

DextromethorphanandQuinidine

Neurology

CYP2D6

CYP2D6poormetabolizers

WarningsandPrecautions,ClinicalPharmacology

Diazepam

Neurology

CYP2C19

CYP2C19poormetabolizers

ClinicalPharmacology

Dinutuximab

Oncology

MYCN

MYCNamplificationpositive

ClinicalStudies

Dolutegravir

InfectiousDiseases

UGT1A1

UGT1A1poormetabolizers

ClinicalPharmacology

Doxepin(1)

Psychiatry

CYP2D6

CYP2D6poormetabolizers

ClinicalPharmacology

Doxepin(2)

Psychiatry

CYP2C19

CYP2C19poormetabolizers

ClinicalPharmacology

DrospirenoneandEthinylEstradiol

Gynecology

CYP2C19

CYP2C19intermediatemetabolizers

ClinicalPharmacology

Eliglustat

InbornErrorsofMetabolism

CYP2D6

CYP2D6ultrarapid,intermediateorpoormetabolizers

IndicationsandUsage,DosageandAdministration,Contraindications,WarningsandPrecautions,DrugInteractions,UseinSpecificPopulations,ClinicalPharmacology,ClinicalStudies

Elosulfase

InbornErrorsofMetabolism

GALNS

N-acetylgalactosamine-6-sulfatasedeficient

IndicationsandUsage,WarningsandPrecautions,UseinSpecificPopulations,ClinicalPharmacology,ClinicalStudies

Eltrombopag(1)

Hematology

F5

FactorVLeidencarriers

WarningsandPrecautions

Eltrombopag(2)

Hematology

SERPINC1

AntithrombinIIIdeficient

WarningsandPrecautions

Erlotinib(1)

Oncology

EGFR

EGFRproteinexpressionpositive

ClinicalStudies

Erlotinib(2)

Oncology

EGFR

EGFRexon19deletionorexon21substitution(L858R)positive

IndicationsandUsage,DosageandAdministration,AdverseReactions,ClinicalPharmacology,ClinicalStudies

Escitalopram(1)

Psychiatry

CYP2D6

CYP2D6poormetabolizers

DrugInteractions

Escitalopram(2)

Psychiatry

CYP2C19

CYP2C19poormetabolizers

AdverseReactions

Esomeprazole

Gastroenterology

CYP2C19

CYP2C19poormetabolizers

DrugInteractions,ClinicalPharmacology

Everolimus(1)

Oncology

ERBB2

HER2proteinoverexpressionnegative

IndicationsandUsage,DosageandAdministration,WarningsandPrecautions,AdverseReactions,DrugInteractions,UseinSpecificPopulations,ClinicalPharmacology,ClinicalStudies

Everolimus(2)

Oncology

ESR1

Estrogenreceptorpositive

ClinicalStudies

Evolocumab

Endocrinology

LDLR

LDLreceptormutationheterozygotesandhomozygotes

IndicationsandUsage,DosageandAdministration,AdverseReactions,UseinSpecificPopulations,ClinicalStudies

Exemestane(1)

Oncology

ESR1

Estrogenreceptorpositive

IndicationsandUsage,DosageandAdministration,ClinicalStudies

Exemestane(2)

Oncology

PGR

Progesteronereceptorpositive

ClinicalStudies

Fesoterodine

Urology

CYP2D6

CYP2D6poormetabolizers

DrugInteractions,ClinicalPharmacology

Fluorouracil(1)

Dermatology

DPYD

DPDdeficient

Contraindications,Warnings

Fluorouracil(2)

Oncology

DPYD

DPDdeficient

Warnings

Fluoxetine

Psychiatry

CYP2D6

CYP2D6poormetabolizers

WarningsandPrecautions,DrugInteractions,ClinicalPharmacology

Flurbiprofen

Rheumatology

CYP2C9

CYP2C9poormetabolizers

ClinicalPharmacology

Fluvoxamine

Psychiatry

CYP2D6

CYP2D6poormetabolizers

DrugInteractions

Fulvestrant

Oncology

ESR1,PGR

Hormonereceptorpositive

IndicationsandUsage,ClinicalPharmacology,ClinicalStudies

Galantamine

Neurology

CYP2D6

CYP2D6poormetabolizers

ClinicalPharmacology

Gefitinib

Oncology

EGFR

EGFRexon19deletionsorexon21substitution(L858R)mutationpositive

IndicationsandUsage,DosageandAdministration,ClinicalPharmacology,ClinicalStudies

Glimepiride

Endocrinology

G6PD

G6PDdeficient

WarningsandPrecautions,AdverseReactions

Glipizide

Endocrinology

G6PD

G6PDdeficient

Precautions

Glyburide

Endocrinology

G6PD

G6PDdeficient

Precautions

Hydralazine

Cardiology

NAT1-2

NAT1-2slowacetylators

ClinicalPharmacology

Ibrutinib

Oncology

del(17p)

Chromosome17pdeletionpositive

IndicationsandUsage,ClinicalStudies

Iloperidone

Psychiatry

CYP2D6

CYP2D6poormetabolizers

DosageandAdministration,WarningsandPrecautions,DrugInteractions,ClinicalPharmacology

Imatinib(1)

Oncology

KIT

KITproteinexpressionpositive,c-KITD816Vmutationnegative

IndicationsandUsage,DosageandAdministration,WarningsandPrecautions,AdverseReactions,UseinSpecificPopulations,ClinicalPharmacology,ClinicalStudies

Imatinib(2)

Oncology

BCR-ABL1

Philadelphiachromosomepositive

IndicationsandUsage,DosageandAdministration,WarningsandPrecautions,AdverseReactions,UseinSpecificPopulations,ClinicalPharmacology,ClinicalStudies

Imatinib(3)

Oncology

PDGFRB

PDGFRgenerearrangementpositive

IndicationsandUsage,DosageandAdministration,ClinicalStudies

Imatinib(4)

Oncology

FIP1L1-PDGFRA

FIP1L1-PDGFRαfusionkinase(orCHIC2deletion)positive

IndicationsandUsage,DosageandAdministration,ClinicalStudies

Imipramine

Psychiatry

CYP2D6

CYP2D6poormetabolizers

Precautions

Indacaterol

Pulmonary

UGT1A1

UGT1A1*28allelehomozygotes

ClinicalPharmacology

Irinotecan

Oncology

UGT1A1

UGT1A1*28allelecarriers

DosageandAdministration,WarningsandPrecautions,ClinicalPharmacology

Ivacaftor

Pulmonary

CFTR

CFTRG551D,G1244E,G1349D,G178R,G551S,S1251N,S1255P,S549N,S549R,R117Hmutationpositive,F508delmutationhomozygotes

IndicationsandUsage,AdverseReactions,UseinSpecificPopulations,ClinicalPharmacology,ClinicalStudies

Lacosamide

Neurology

CYP2C19

CYP2C19poormetabolizers

ClinicalPharmacology

Lansoprazole

Gastroenterology

CYP2C19

CYP2C19intermediateorpoormetabolizers

DrugInteractions

Lapatinib(1)

Oncology

ERBB2

HER2proteinoverexpressionpositive

IndicationsandUsage,DosageandAdministration,AdverseReactions,UseinSpecificPopulations,ClinicalPharmacology,ClinicalStudies

Lapatinib(2)

Oncology

HLA-DQA1,HLA-DRB1

HLA-DQA1*0201orHLA-DRB1*0701allelecarriers

ClinicalPharmacology

Lenalidomide

Hematology

del(5q)

Chromosome5qdeletionpositive

BoxedWarning,IndicationsandUsage,AdverseReactions,UseinSpecificPopulations,ClinicalStudies

Lesinurad

Rheumatology

CYP2C9

CYP2C9poormetabolizers

ClinicalPharmacology

Letrozole

Oncology

ESR1,PGR

Hormonereceptorpositive

IndicationsandUsage,AdverseReactions,ClinicalPharmacology,ClinicalStudies

Lomitapide

Endocrinology

LDLR

LDLreceptormutationhomozygotes

IndicationandUsage,WarningsandPrecautions,AdverseReactions,ClinicalStudies

IvacaftorandLumacaftor

Pulmonary

CFTR

CFTRF508delmutationhomozygotes

IndicationsandUsage,AdverseReactions,ClinicalPharmacology,ClinicalStudies

Mafenide

InfectiousDiseases

G6PD

G6PDdeficient

Warnings,AdverseReactions

Mercaptopurine

Oncology

TPMT

TPMTintermediateorpoormetabolizers

ClinicalPharmacology,Warnings,Precautions,AdverseReactions,DosageandAdministration

MethyleneBlue

Hematology

G6PD

G6PDdeficient

Precautions

Metoclopramide(1)

Gastroenterology

CYB5R1-4

NADHcytochromeb5reductasedeficient

Precautions

Metoclopramide(2)

Gastroenterology

G6PD

G6PDdeficient

Precautions

Metoprolol

Cardiology

CYP2D6

CYP2D6poormetabolizers

ClinicalPharmacology

Mipomersen

Endocrinology

LDLR

LDLreceptormutationheterozygotesandhomozygotes

IndicationsandUsage,WarningsandPrecautions,AdverseReactions,UseinSpecificPopulations,ClinicalStudies

Modafinil

Psychiatry

CYP2D6

CYP2D6poormetabolizers

ClinicalPharmacology,Precautions

MycophenolicAcid

Transplantation

HPRT1

HGPRTdeficient

WarningsandPrecautions

NalidixicAcid

InfectiousDiseases

G6PD

G6PDdeficient

Precautions,AdverseReactions

Nefazodone

Psychiatry

CYP2D6

CYP2D6poormetabolizers

Precautions

Nilotinib(1)

Oncology

BCR-ABL1

Philadelphiachromosomepositive

IndicationsandUsage,DosageandAdministration,AdverseReactions,UseinSpecificPopulations,ClinicalPharmacology,ClinicalStudies

Nilotinib(2)

Oncology

UGT1A1

UGT1A1*28allelehomozygotes

ClinicalPharmacology

Nitrofurantoin

InfectiousDiseases

G6PD

G6PDdeficient

Warnings,AdverseReactions

Nivolumab(1)

Oncology

BRAF

BRAFV600mutationpositive

IndicationsandUsage,AdverseReactions,ClinicalStudies

Nivolumab(2)

Oncology

CD274

PD-L1proteinexpressionpositive

ClinicalPharmacology

Nortriptyline

Psychiatry

CYP2D6

CYP2D6poormetabolizers

Precautions

Obinutuzumab

Oncology

MS4A1

CD20antigenpositive

ClinicalStudies

Olaparib

Oncology

BRCA1-2

BRCA1-2mutationpositive

IndicationsandUsage,DosageandAdministration,WarningsandPrecautions,AdverseReactions,ClinicalPharmacology,ClinicalStudies

Omacetaxine

Oncology

BCR-ABL1

Philadelphiachromosomepositive

ClinicalPharmacology,ClinicalStudies

Ombitasvir,

Paritaprevir,Ritonavir,andDasabuvir

InfectiousDiseases

IFNL3

IL28Brs12979860Tallelecarriers(non-C/Cgenotype)

ClinicalStudies

Omeprazole

Gastroenterology

CYP2C19

CYP2C19poormetabolizers

DrugInteractions

Osimertinib

Oncology

EGFR

EGFRT790Mmutationpositive

IndicationsandUsage,DosageandAdministration,AdverseReactions,ClinicalPharmacology,ClinicalStudies

Palbociclib(1)

Oncology

ESR1

Estrogenreceptorpositive

IndicationsandUsage,AdverseReactions,ClinicalPharmacology,ClinicalStudies

Palbociclib(2)

Oncology

ERBB2

HER2proteinoverexpressionnegative

IndicationsandUsage,AdverseReactions,ClinicalStudies

Palonosetron

Gastroenterology

CYP2D6

CYP2D6poormetabolizers

ClinicalPharmacology

Panitumumab(1)

Oncology

EGFR

EGFRproteinexpressionpositive

ClinicalPharmacology,ClinicalStudies

Panitumumab(2)

Oncology

KRAS

KRAScodon12and13mutationnegative

IndicationsandUsage,DosageandAdministration,WarningsandPrecautions,AdverseReactions,ClinicalPharmacology,ClinicalStudies

Pantoprazole

Gastroenterology

CYP2C19

CYP2C19poormetabolizers

ClinicalPharmacology

ParathyroidHormone

InbornErrorsofMetabolism

CASR

Calciumsensingreceptormutationpositive

IndicationsandUsage,ClinicalStudies

Paroxetine

Psychiatry

CYP2D6

CYP2D6extensiveandpoormetabolizers

DrugInteractions,ClinicalPharmacology

Pazopanib

Oncology

UGT1A1

UGT1A1*28allelehomozygotes

ClinicalPharmacology,WarningsandPrecautions

PEG-3350,SodiumSulfate,SodiumChloride,PotassiumChloride,SodiumAscorbate,andAscorbicAcid

Gastroenterology

G6PD

G6PDdeficient

WarningsandPrecautions

Pegloticase

Rheumatology

G6PD

G6PDdeficient

Contraindications,PatientCounselingInformation

Pembrolizumab(1)

Oncology

BRAF

BRAFV600mutationpositive

IndicationsandUsage,AdverseReactions,ClinicalStudies

Pembrolizumab(2)

Oncology

CD274

PD-L1proteinexpressionpositive

IndicationsandUsage,DosageandAdministration,ClinicalPharmacology,ClinicalStudies

Perphenazine

Psychiatry

CYP2D6

CYP2D6poormetabolizers

ClinicalPharmacology,Precautions

Pertuzumab

Oncology

ERBB2

HER2proteinoverexpressionpositive

IndicationsandUsage,WarningsandPrecautions,AdverseReactions,ClinicalPharmacology,ClinicalStudies

Phenytoin(1)

Neurology

CYP2C9

CYP2C9variantallelecarriers

ClinicalPharmacology

Phenytoin(2)

Neurology

CYP2C19

CYP2C19variantallelecarriers

ClinicalPharmacology

Phenytoin(3)

Neurology

HLA-B

HLA-B*1502allelecarriers

Warnings

Pimozide

Psychiatry

CYP2D6

CYP2D6poormetabolizers

Precautions,DosageandAdministration

Ponatinib

Oncology

BCR-ABL1

Philadelphiachromosomepositive;T315Imutationpositive

IndicationsandUsage,WarningsandPrecautions,AdverseReactions,UseinSpecificPopulations,ClinicalPharmacology,ClinicalStudies

Prasugrel(1)

Cardiology

CYP2C19

CYP2C19poormetabolizers

UseinSpecificPopulations,ClinicalPharmacology,ClinicalStudies

Prasugrel(2)

Cardiology

CYP2C9

CYP2C9variantallelecarriers

UseinSpecificPopulations,ClinicalPharmacology,ClinicalStudies

Prasugrel(3)

Cardiology

CYP3A5

CYP3A5variantallelecarriers

UseinSpecificPopulations,ClinicalPharmacology,ClinicalStudies

Prasugrel(4)

Cardiology

CYP2B6

CYP2B6variantallelecarriers

UseinSpecificPopulations,ClinicalPharmacology,ClinicalStudies

Pravastatin

Endocrinology

LDLR

LDLreceptormutationheterozygotesandhomozygotes

IndicationsandUsage,UseinSpecificPopulations,ClinicalStudies

PrilocaineandLidocaine(1)

Anesthesiology

CYB5R1-4

NADHcytochromeb5reductasedeficient

WarningsandPrecautions

PrilocaineandLidocaine(2)

Anesthesiology

G6PD

G6PDdeficient

WarningsandPrecautions

Primaquine

InfectiousDiseases

G6PD

G6PDdeficient

WarningsandPrecautions,AdverseReactions

Propafenone

Cardiology

CYP2D6

CYP2D6poormetabolizers

DosageandAdministration,WarningsandPrecautions,ClinicalPharmacology

Propranolol

Cardiology

CYP2D6

CYP2D6poormetabolizers

ClinicalPharmacology

Protriptyline

Psychiatry

CYP2D6

CYP2D6poormetabolizers

Precautions

Quinidine

Cardiology

CYP2D6

CYP2D6poormetabolizers

Precautions

QuinineSulfate(1)

InfectiousDiseases

G6PD

G6PDdeficient

Contraindications

QuinineSulfate(2)

InfectiousDiseases

CYP2D6

CYP2D6poormetabolizers

DrugInteractions

Rabeprazole

Gastroenterology

CYP2C19

CYP2C19poormetabolizers

DrugInteractions,ClinicalPharmacology

Rasburicase(1)

Oncology

G6PD

G6PDdeficient

BoxedWarning,Contraindications,WarningsandPrecautions

Rasburicase(2)

Oncology

CYB5R1-4

NADHcytochromeb5reductasedeficient

BoxedWarning,WarningsandPrecautions

Rifampin,Isoniazid,andPyrazinamide

InfectiousDiseases

NAT1-2

NAT1-2slowacetylators

ClinicalPharmacology,AdverseReactions

Risperidone

Psychiatry

CYP2D6

CYP2D6poormetabolizers

ClinicalPharmacology

Rituximab

Oncology

MS4A1

CD20antigenpositive

IndicationsandUsage,DosageandAdministration,AdverseReactions,UseinSpecificPopulations,ClinicalPharmacology,ClinicalStudies

Rosuvastatin(1)

Endocrinology

SLCO1B1

SLCO1B1reducedfunctionallelehomozygotes

ClinicalPharmacology

Rosuvastatin(2)

Endocrinology

LDLR

LDLreceptormutationheterozygotesandhomozygotes

IndicationsandUsage,DosageandAdministration,AdverseReactions,UseinSpecificPopulations,ClinicalPharmacology,ClinicalStudies

Sevoflurane

Anesthesiology

RYR1

Ryanodinereceptormutationpositive

Warnings

Simeprevir

InfectiousDiseases

IFNL3

IL28Brs12979860Tallelecarriers(non-C/Cgenotype)

ClinicalPharmacology,ClinicalStudies

SodiumNitrite

Toxicology

G6PD

G6PDdeficient

WarningsandPrecautions

SodiumPhenylacetateandSodiumBenzoate

InbornErrorsofMetabolism

NAGS,CPS1,ASS1,OTC,ASL,ABL2

Ureacycleenzymedeficient

IndicationsandUsage,DosageandAdministration,WarningsandPrecautions,AdverseReactions,DrugInteractions,UseinSpecificPopulations,Overdosage,ClinicalPharmacology,ClinicalStudies

Sofosbuvir

InfectiousDiseases

IFNL3

IL28Brs12979860Tallelecarriers(non-C/Cgenotype)

ClinicalStudies

Succimer

Hematology

G6PD

G6PDdeficient

ClinicalPharmacology

SulfamethoxazoleandTrimethoprim

InfectiousDiseases

G6PD

G6PDdeficient

Precautions

Tamoxifen(1)

Oncology

ESR1,PGR

Hormonereceptorpositive

ClinicalPharmacology,IndicationsandUsage,Precautions,AdverseReactions

Tamoxifen(2)

Oncology

F5

FactorVLeidencarriers

Warnings

Tamoxifen(3)

Oncology

F2

ProthrombinG0Aallelepositive

Warnings

Telaprevir

InfectiousDiseases

IFNL3

IL28Brs12979860Tallelecarriers(C/TandT/Tgenotype)

ClinicalPharmacology,ClinicalStudies

Tetrabenazine

Neurology

CYP2D6

CYP2D6poormetabolizers

DosageandAdministration,WarningsandPrecautions,UseinSpecificPopulations,ClinicalPharmacology

Thioguanine

Oncology

TPMT

TPMTintermediateorpoormetabolizers

Warn