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  1. Science and Research | 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 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 - 3.83 MB)

Pharmacogenomic Biomarkers in Drug Labeling

  Drug Therapeutic Area* Biomarker Labeling Sections
  Abacavir Infectious Diseases HLA-B Boxed Warning, Dosage and Administration, Contraindications, Warnings and Precautions
  Abemaciclib (1) Oncology ESR
(Hormone Receptor)
Indications and Usage, Adverse Reactions, Clinical Studies
  Abemaciclib (2) Oncology ERBB2
(HER2)
Indications and Usage, Adverse Reactions, Clinical Studies
  Abemaciclib (3) Oncology MKI67 Clinical Studies
  Abrocitinib Dermatology CYP2C19 Dosage and Administration, Use in Specific Populations, Clinical Pharmacology
  Adagrasib Oncology KRAS Indications and Usage, Dosage and Administration, Adverse Reactions, Clinical Pharmacology, Clinical Studies
  Ado-Trastuzumab Emtansine Oncology ERBB2
(HER2)
Indications and Usage, Dosage and Administration, Adverse Reactions, Clinical Pharmacology, Clinical Studies
  Aducanumab-avwa Neurology APOE Warnings and Precautions, Clinical Studies
  Afatinib Oncology EGFR Indications and Usage, Dosage and Administration, Adverse Reactions, Clinical Studies
  Alectinib Oncology ALK Indications and Usage, Dosage and Administration, Adverse Reactions, Clinical Pharmacology, Clinical Studies
  Alglucosidase Alfa Inborn Errors of Metabolism GAA Warnings and Precautions
  Allopurinol Oncology HLA-B Warnings
  Alpelisib (1)  Oncology ERBB2
(HER2)
Indication and Usage, Dosage and Administration, Adverse Reactions, Clinical Studies
  Alpelisib (2) Oncology ESR
(Hormone Receptor)
Indication and Usage, Dosage and Administration, Adverse Reactions, Clinical Studies
  Alpelisib (3) Oncology PIK3CA Indication and Usage, Dosage and Administration, Adverse Reactions, Clinical Studies
  Amifampridine Neurology NAT2 Dosage and Administration, Adverse Reactions, Use in Specific Populations, Clinical Pharmacology
  Amifampridine Phosphate Neurology NAT2 Dosage and Administration, Use in Specific Populations, Clinical Pharmacology
  Amikacin Infectious Diseases     MT-RNR1     Warnings and Precautions
  Amitriptyline Psychiatry CYP2D6 Precautions
  Amivantamab-vmjw Oncology EGFR Indications and Usage, Dosage and Administration, Adverse Reactions, Clinical Studies
  Amoxapine Psychiatry CYP2D6 Precautions
  Amphetamine Psychiatry CYP2D6 Clinical Pharmacology
  Anakinra Rheumatology NLRP3 Indications and Usage, Dosage and Administration, Warnings and Precautions, Adverse Reactions, Use in Specific Populations, Clinical Pharmacology, Clinical Studies
  Anastrozole Oncology ESR, PGR
(Hormone Receptor)
Indications and Usage, Adverse Reactions, Drug Interactions, Clinical Studies
  Anifrolumab-fnia Rheumatology Gene Signature
(IFN)
Clinical Pharmacology, Clinical Studies
  Arformoterol (1) Pulmonary UGT1A1 Clinical Pharmacology
  Arformoterol (2) Pulmonary CYP2D6 Clinical Pharmacology
  Aripiprazole Psychiatry CYP2D6 Dosage and Administration, Use in Specific Populations, Clinical Pharmacology
  Aripiprazole Lauroxil Psychiatry CYP2D6 Dosage and Administration, Use in Specific Populations, Clinical Pharmacology
  Arsenic Trioxide Oncology PML-RARA Indications and Usage, Clinical Studies
  Articaine and Epinephrine (1) Anesthesiology G6PD Warnings and Precautions
  Articaine and Epinephrine (2) Anesthesiology Nonspecific
(Congenital Methemoglobinemia)
Warnings and Precautions
  Asciminib Oncology BCR-ABL1
(Philadelphia chromosome)
Indications and Usage, Dosage and Administration, Adverse Reactions, Use in Specific Populations, Clinical Studies
  Ascorbic Acid Endocrinology G6PD Dosage and Administration, Warnings and Precautions, Adverse Reactions, Patient Counseling Information
  Atezolizumab (1) Oncology CD274
(PD-L1)
Indications and Usage, Dosage and Administration, Adverse Reactions, Clinical Pharmacology, Clinical Studies
  Atezolizumab (2)   Oncology Gene Signature
(T-effector)
Clinical Studies
  Atezolizumab (3) Oncology EGFR Indications and Usage, Adverse Reactions, Clinical Studies
  Atezolizumab (4) Oncology ALK Indications and Usage, Adverse Reactions, Clinical Studies
  Atezolizumab (5) Oncology BRAF Indications and Usage, Dosage and Administration, Adverse Reactions, Clinical Studies
  Atomoxetine Psychiatry CYP2D6 Dosage and Administration, Warnings and Precautions, Adverse Reactions, Drug Interactions, Use in Specific Populations, Clinical Pharmacology
  Ascorbic Acid, PEG-3350, Potassium Chloride, Sodium Ascorbate, Sodium Chloride, and Sodium Sulfate Gastroenterology G6PD Warnings and Precautions, Adverse Reactions
  Avapritinib (1) Oncology PDGFRA Indications and Usage, Dosage and Administration, Clinical Studies
  Avapritinib (2) Oncology KIT Clinical Studies
  Avatrombopag (1) Hematology F2
(Prothrombin)
Warnings and Precautions
  Avatrombopag (2) Hematology F5
(Factor V Leiden)
Warnings and Precautions
  Avatrombopag (3) Hematology PROC Warnings and Precautions
  Avatrombopag (4) Hematology PROS1 Warnings and Precautions
  Avatrombopag (5) Hematology SERPINC1
(Antithrombin III)
Warnings and Precautions
  Avatrombopag (6) Hematology CYP2C9 Clinical Pharmacology
  Avelumab Oncology CD274
(PD-L1)
Clinical Studies
  Azacitidine (1) Oncology CBL Clinical Studies
  Azacitidine (2) Oncology PTPN11 Clinical Studies
  Azacitidine (3) Oncology RAS Clinical Studies
  Azathioprine (1) Rheumatology TPMT Dosage and Administration,  Warnings, Precautions, Drug Interactions, Adverse Reactions, Clinical Pharmacology
  Azathioprine (2) Rheumatology NUDT15 Dosage and Administration, Warnings, Precautions, Adverse Reactions, Clinical Pharmacology
  Belinostat Oncology UGT1A1 Dosage and Administration, Clinical Pharmacology
  Belzutifan (1) Oncology CYP2C19 Warnings and Precautions, Drug Interactions, Use in Specific Populations, Clinical Pharmacology
  Belzutifan (2) Oncology UGT2B17 Warnings and Precautions, Drug Interactions, Use in Specific Populations, Clinical Pharmacology
  Belzutifan (3) Oncology VHL Clinical Studies
  Betaine Inborn Errors of Metabolism CBS, MMADHC, MTHFR (Homocystinuria Deficiency) Indications and Usage, Warnings and Precautions, Clinical Pharmacology, Clinical Studies
  Binimetinib (1) Oncology BRAF Indications and Usage, Dosage and Administration, Warnings and Precautions, Adverse Reactions, Use in Specific Populations, Clinical Studies  
  Binimetinib (2) Oncology UGT1A1 Clinical Pharmacology
  Blinatumomab (1) Oncology BCR-ABL1
(Philadelphia chromosome)
Adverse Reactions, Clinical Studies
  Blinatumomab (2) Oncology CD19 Indications and Usage
  Boceprevir Infectious Diseases IFNL3
(IL28B)
Clinical Pharmacology
  Bosutinib Oncology BCR-ABL1
(Philadelphia chromosome)
Indications and Usage, Dosage and Administration, Warnings and Precautions, Adverse Reactions, Use in Specific Populations, Clinical Studies
  Brentuximab Vedotin (1) Oncology ALK Use in Specific Populations, Clinical Studies
  Brentuximab Vedotin (2) Oncology TNFRSF8
(CD30)
Indications and Usage, Dosage and Administration, Adverse Reactions, Use in Specific Populations, Clinical Studies
  Brexpiprazole Psychiatry CYP2D6 Dosage and Administration, Use in Specific Populations, Clinical Pharmacology
  Brigatinib Oncology ALK Indications and Usage, Dosage and Administration, Adverse Reactions, Clinical Studies
  Brivaracetam Neurology CYP2C19 Clinical Pharmacology
  Bupivacaine (1) Anesthesiology G6PD Warnings
  Bupivacaine (2) Anesthesiology Nonspecific
(Congenital Methemoglobinemia)
Warnings
  Bupropion Psychiatry CYP2D6 Clinical Pharmacology
  Busulfan Oncology BCR-ABL1
(Philadelphia chromosome)
Clinical Studies
  Cabotegravir and Rilpivirine (1) Infectious Diseases HLA-B Clinical Studies
  Cabotegravir and Rilpivirine (2) Infectious Diseases UGT1A1 Clinical Pharmacology
  Cabozantinib Oncology RET Clinical Studies
  Capmatinib Oncology MET Indications and Usage, Dosage and Administration, Clinical Studies
  Capecitabine (1) Oncology DPYD Warnings and Precautions, Clinical Pharmacology, Patient Counseling Information
  Capecitabine (2) Oncology ERBB2
(HER2)
Indications and Usage, Dosage and Administration, Adverse Reactions, Clinical Studies
  Capivasertib (1) Oncology AKT1 Indications and Usage, Dosage and Administration, Adverse Reactions, Clinical Studies
  Capivasertib (2) Oncology ERBB2
(HER2)
Indications and Usage, Dosage and Administration, Clinical Studies
  Capivasertib (3) Oncology ESR
(Hormone Receptor)
Indications and Usage, Dosage and Administration, Clinical Studies
  Capivasertib (4) Oncology PIK3CA Indications and Usage, Dosage and Administration, Adverse Reactions, Clinical Studies
  Capivasertib (5) Oncology PTEN Indications and Usage, Dosage and Administration, Adverse Reactions, Clinical Studies
  Carbamazepine (1) Neurology HLA-B Boxed Warning, Warnings, Precautions
  Carbamazepine (2) Neurology HLA-A Warnings
  Carglumic Acid Inborn Errors of Metabolism NAGS Indications and Usage, Dosage and Administration, Warnings and Precautions, Use in Specific Populations, Clinical Pharmacology, Clinical Studies
  Cariprazine Psychiatry CYP2D6 Clinical Pharmacology
  Carisoprodol Rheumatology CYP2C19 Use in Specific Populations, Clinical Pharmacology
  Carvedilol Cardiology CYP2D6 Drug Interactions, Clinical Pharmacology
  Casimersen Neurology DMD Indications and Usage, Adverse Reactions, Use in Specific Populations, Clinical Pharmacology, Clinical Studies
  Ceftriaxone (1) Infectious Diseases G6PD Warnings
  Ceftriaxone (2) Infectious Diseases Nonspecific
(Congenital Methemoglobinemia)
Warnings
  Celecoxib Rheumatology CYP2C9 Dosage and Administration, Use in Specific Populations, Clinical Pharmacology
  Cemiplimab-rwlc (1) Oncology ALK Indications and Usage, Clinical Studies
  Cemiplimab-rwlc (2) Oncology CD274
(PD-L1)
Indications and Usage, Dosage and Administration, Clinical Studies
  Cemiplimab-rwlc (3) Oncology EGFR Indications and Usage, Clinical Studies
  Cemiplimab-rwlc (4) Oncology ROS1 Indications and Usage, Clinical Studies
  Ceritinib Oncology ALK Indications and Usage, Dosage and Administration, Warning and Precautions, Adverse Reactions, Clinical Studies
  Cerliponase Alfa Inborn Errors of Metabolism TPP1 Indications and Usage, Use in Specific Populations, Clinical Studies
  Cetuximab (1) Oncology EGFR Indications and Usage, Dosage and Administration, Adverse Reactions, Clinical Studies
  Cetuximab (2) Oncology RAS Indications and Usage, Dosage and Administration, Warnings and Precautions, Adverse Reactions, Clinical Studies
  Cetuximab (3) Oncology BRAF Indications and Usage, Dosage and Administration, Adverse Reactions, Use in Specific Populations, Clinical Studies
  Cevimeline Dental CYP2D6 Precautions
  Chloroprocaine (1) Anesthesiology G6PD Warnings
  Chloroprocaine (2) Anesthesiology Nonspecific
(Congenital Methemoglobinemia)
Warnings
  Chloroquine Infectious Diseases G6PD Precautions, Adverse Reactions
  Chlorpropamide Endocrinology G6PD Precautions
  Cholic Acid Inborn Errors of Metabolism AMACR, AKR1D1, CYP7A1, CYP27A1, DHCR7, HSD3B2
(Bile Acid Synthesis Disorders)
Indications and Usage, Dosage and Administration, Warnings and Precautions, Adverse Reactions, Use in Specific Populations, Clinical Studies
  Cisplatin Oncology TPMT Adverse Reactions
  Citalopram (1) Psychiatry CYP2C19 Dosage and Administration, Warnings, Clinical Pharmacology
  Citalopram (2) Psychiatry CYP2D6 Clinical Pharmacology
  Clobazam Neurology CYP2C19 Dosage and Administration, Use in Specific Populations, Clinical Pharmacology
  Clomipramine Psychiatry CYP2D6 Precautions
  Clopidogrel Cardiology CYP2C19 Boxed Warning, Warnings and Precautions, Clinical Pharmacology
  Clozapine Psychiatry CYP2D6 Dosage and Administration, Use in Specific Populations, Clinical Pharmacology
  Cobimetinib Oncology BRAF Indications and Usage, Dosage and Administration, Adverse Reactions, Clinical Studies
  Codeine Anesthesiology CYP2D6 Boxed Warning, Warnings and Precautions, Use in Specific Populations, Patient Counseling Information
  Crizanlizumab-tmca Hematology HBB Adverse Reactions, Clinical Studies
  Crizotinib (1) Oncology ALK Indications and Usage, Dosage and Administration, Adverse Reactions, Use in Specific Populations, Clinical Pharmacology, Clinical Studies
  Crizotinib (2) Oncology ROS1 Indications and Usage, Dosage and Administration, Adverse Reactions, Use in Specific Populations, Clinical Studies
  Dabrafenib (1) Oncology BRAF Indications and Usage, Dosage and Administration, Warnings and Precautions, Adverse Reactions, Use in Specific Populations, Clinical Pharmacology, Clinical Studies
  Dabrafenib (2) Oncology G6PD Warnings and Precautions, Adverse Reactions, Patient Counseling Information
  Dabrafenib (3) Oncology RAS Dosage and Administration, Warnings and Precautions
  Daclatasvir Infectious Diseases IFNL3
(IL28B)
Clinical Studies
  Dacomitinib Oncology EGFR Indications and Usage, Dosage and Administration, Adverse Reactions, Use in Specific Populations, Clinical Studies
  Dapsone (1) Dermatology G6PD Warnings and Precautions, Use in Specific Populations, Patient Counseling Information
  Dapsone (2) Dermatology Nonspecific
(Congenital Methemoglobinemia)
Warnings and Precautions, Adverse Reactions, Patient Counseling Information
  Dapsone (3) Infectious Diseases G6PD Precautions, Adverse Reactions, Overdosage
  Darifenacin Urology CYP2D6 Clinical Pharmacology
  Dasabuvir, Ombitasvir, Paritaprevir, and Ritonavir Infectious Diseases IFNL3
(IL28B)
Clinical Studies
  Dasatinib Oncology BCR-ABL1
(Philadelphia chromosome)
Indications and Usage, Dosage and Administration, Warnings and Precautions, Adverse Reactions, Use in Specific Populations, Clinical Studies
  Denileukin Diftitox Oncology IL2RA
(CD25 antigen)
Indications and Usage, Clinical Studies
  Desipramine Psychiatry CYP2D6 Precautions
  Desflurane Anesthesiology CACNA1S, RYR1 
(Genetic Susceptibility to Malignant Hyperthermia)
Contraindications, Warnings and Precautions, Clinical Pharmacology
  Desmopressin  Hematology F8 Indications and Usage, Dosage and Administration, Clinical Pharmacology
  Desvenlafaxine Psychiatry CYP2D6 Clinical Pharmacology
  Deutetrabenazine Neurology CYP2D6 Dosage and Administration, Use in Specific Populations, Clinical Pharmacology
  Dexlansoprazole Gastroenterology CYP2C19 Drug Interactions, Clinical Pharmacology
  Dextromethorphan and Quinidine Neurology CYP2D6 Warnings and Precautions, Clinical Pharmacology
  Diazepam Neurology CYP2C19 Clinical Pharmacology
  Dinutuximab Oncology MYCN Clinical Studies
  Docetaxel Oncology ESR, PGR
(Hormone Receptor)
Clinical Studies
  Dolutegravir Infectious Diseases UGT1A1 Clinical Pharmacology
  Donepezil Neurology CYP2D6 Clinical Pharmacology
  Dostarlimab-gxly Oncology Microsatellite Instability, Mismatch Repair Indications and Usage, Dosage and Administration, Adverse Reactions, Clinical Studies
  Doxepin (1) Psychiatry CYP2D6 Clinical Pharmacology
  Doxepin (2) Psychiatry CYP2C19 Clinical Pharmacology
  Dronabinol Gastroenterology CYP2C9 Use in Specific Populations, Clinical Pharmacology
  Drospirenone and Ethinyl Estradiol Gynecology CYP2C19 Clinical Pharmacology
  Duloxetine Psychiatry CYP2D6 Drug Interactions
  Durvalumab (1) Oncology     ALK Indications and Usage, Clinical Studies
  Durvalumab (2) Oncology  EGFR Indications and Usage, Clinical Studies
  Durvalumab (3) Oncology CD274
(PD-L1)
Clinical Pharmacology, Clinical Studies
  Duvelisib Oncology Chromosome 17p Clinical Studies
  Eculizumab (1) Neurology ACHR Indications and Usage, Clinical Studies
  Eculizumab (2) Neurology AQP4 Indications and Usage, Clinical Studies
  Efavirenz Infectious Diseases CYP2B6 Clinical Pharmacology
  Efgartigimod Alfa-fcab Neurology ACHR Indications and Usage, Clinical Pharmacology, Clinical Studies
  Eflornithine Oncology MYCN Adverse Reactions, Clinical Studies
  Elacestrant (1) Oncology     ESR
(Hormone Receptor)
Indications and Usage, Dosage and Administration, Adverse Reactions, Clinical Studies
  Elacestrant (2) Oncology     ERBB2
(HER2)
Indications and Usage, Dosage and Administration, Adverse Reactions, Clinical Studies
  Elagolix Gynecology SLCO1B1 Clinical Pharmacology
  Elbasvir and Grazoprevir Infectious Diseases IFNL3
(IL28B)
Clinical Studies
  Elexacaftor, Ivacaftor, and Tezacaftor Pulmonary CFTR Indications and Usage, Use in Specific Populations, Clinical Pharmacology, Clinical Studies
  Eliglustat Inborn Errors of Metabolism CYP2D6 Indications and Usage, Dosage and Administration, Contraindications, Warnings and Precautions, Drug Interactions, Use in Specific Populations, Clinical Pharmacology, Clinical Studies
  Elranatamab-bcmm (1) Oncology Chromosome 17p Clinical Studies
  Elranatamab-bcmm (2) Oncology Chromosome 4p;14q Clinical Studies
  Elranatamab-bcmm (3) Oncology Chromosome 14q;16q Clinical Studies
  Elosulfase Inborn Errors of Metabolism GALNS Indications and Usage, Warnings and Precautions, Use in Specific Populations, Clinical Pharmacology, Clinical Studies
  Eltrombopag (1) Hematology F5
(Factor V Leiden)
Warnings and Precautions
  Eltrombopag (2) Hematology SERPINC1
(Antithrombin III)
Warnings and Precautions
  Eltrombopag (3) Hematology Chromosome 7 Adverse Reactions
  Eltrombopag (4) Hematology Chromosome 13 Adverse Reactions
  Emapalumab-lzsg Hematology PRF1, RAB27A, SH2D1A, STXBP2, STX11, UNC13D, XIAP (Hemophagocytic Lymphohistiocytosis) Clinical Studies
  Enasidenib Oncology IDH2 Indications and Usage, Dosage and Administration, Clinical Pharmacology, Clinical Studies
  Encorafenib (1) Oncology BRAF Indications and Usage, Dosage and Administration, Warnings and Precautions, Adverse Reactions, Use in Specific Populations, Clinical Pharmacology, Clinical Studies, Patient Counseling Information
  Encorafenib (2) Oncology RAS Dosage and Administration, Warnings and Precautions, Clinical Studies  
  Entrectinib (1) Oncology ROS1 Indications and Usage, Dosage and Administration, Adverse Reactions, Use in Specific Populations, Clinical Pharmacology, Clinical Studies
  Entrectinib (2) Oncology NTRK Indications and Usage, Dosage and Administration, Adverse Reactions, Use in Specific Populations, Clinical Pharmacology, Clinical Studies
  Eplontersen Neurology TTR Adverse Reactions, Clinical Pharmacology, Clinical Studies
  Erdafitinib (1) Oncology FGFR Indications and Usage, Dosage and Administration, Adverse Reactions, Clinical Studies, Patient Counseling Information
  Erdafitinib (2)  Oncology CYP2C9 Use in Specific Populations, Clinical Pharmacology
  Eribulin (1) Oncology ERBB2
(HER2)
Clinical Studies
  Eribulin (2) Oncology ESR, PGR
(Hormone Receptor)
Clinical Studies
  Erlotinib Oncology EGFR Indications and Usage, Dosage and Administration, Adverse Reactions, Clinical Studies
  Erythromycin and Sulfisoxazole Infectious Diseases G6PD Precautions
  Escitalopram (1) Psychiatry CYP2D6 Drug Interactions
  Escitalopram (2) Psychiatry CYP2C19 Adverse Reactions
  Esomeprazole Gastroenterology CYP2C19 Drug Interactions, Clinical Pharmacology
  Estradiol and Progesterone (1) Gynecology PROC Contraindications
  Estradiol and Progesterone (2) Gynecology PROS1 Contraindications
  Estradiol and Progesterone (3) Gynecology

SERPINC1
(Antithrombin III)

Contraindications
  Estradiol Valerate Gynecology ESR, PGR
(Hormone Receptor)
Warnings
  Eteplirsen Neurology DMD Indications and Usage, Adverse Reactions, Use in Specific Populations, Clinical Studies
  Etrasimod Gastroenterology CYP2C9 Drug Interactions, Use in Specific Populations, Clinical Pharmacology
  Everolimus (1) Oncology ERBB2
(HER2)
Indications and Usage, Dosage and Administration, Warnings and Precautions, Adverse Reactions, Use in Specific Populations, Clinical Pharmacology, Clinical Studies
  Everolimus (2) Oncology ESR
(Hormone Receptor)
Indications and Usage, Dosage and Administration, Warnings and Precautions, Adverse Reactions, Use in Specific Populations, Clinical Pharmacology, Clinical Studies
  Evinacumab-dgnb (1) Endocrinology LDLR Clinical Studies
  Evinacumab-dgnb (2) Endocrinology     Nonspecific
(Homozygous Familial Hypercholesterolemia)
Indication and Usage, Adverse Reactions, Use in Specific Populations, Clinical Pharmacology, Clinical Studies
  Evolocumab (1) Endocrinology Nonspecific
(Heterozygous Familial Hypercholesterolemia)
Indications and Usage, Dosage and Administration, Adverse Reactions, Use in Specific Populations, Clinical Pharmacology, Clinical Studies
  Evolocumab (2) Endocrinology Nonspecific
(Homozygous Familial Hypercholesterolemia)
Indications and Usage, Dosage and Administration, Adverse Reactions, Use in Specific Populations, Clinical Pharmacology, Clinical Studies
  Exemestane Oncology ESR, PGR
(Hormone Receptor)
Indications and Usage, Dosage and Administration, Clinical Studies
  Fam-Trastuzumab Deruxtecan-nxki (1) Oncology

ERBB2
(HER2)

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

  Fam-Trastuzumab Deruxtecan-nxki (2) Oncology ESR
(Hormone Receptor)
Clinical Studies
  Fesoterodine Urology CYP2D6 Drug Interactions, Clinical Pharmacology
  Fosphenytoin (1) Neurology CYP2C9 Warnings and Precautions, Use in Specific Populations, Clinical Pharmacology
  Fosphenytoin (2)  Neurology HLA-B Warnings and Precautions
  Flibanserin (1) Gynecology CYP2C9 Clinical Pharmacology
  Flibanserin (2) Gynecology CYP2C19 Adverse Reactions, Use in Specific Populations, Clinical Pharmacology
  Flibanserin (3) Gynecology CYP2D6 Clinical Pharmacology
  Fluorouracil (1) Dermatology DPYD Contraindications, Warnings
  Fluorouracil (2) Oncology DPYD Warnings and Precautions, Patient Counseling Information
  Fluoxetine Psychiatry CYP2D6 Warnings and Precautions, Drug Interactions, Clinical Pharmacology
  Flurbiprofen Rheumatology CYP2C9 Clinical Pharmacology
  Flutamide Oncology G6PD Warnings
  Fluvoxamine Psychiatry CYP2D6 Drug Interactions
  Formoterol (1) Pulmonary CYP2D6 Clinical Pharmacology
  Formoterol (2) Pulmonary CYP2C19 Clinical Pharmacology
  Fosdenopterin Neurology MOCS1 Indications and Usage, Dosage and Administration, Adverse Reactions, Use in Specific Populations, Clinical Pharmacology, Clinical Studies
  Fruquintinib Oncology RAS Indications and Usage, Clinical Studies
  Fulvestrant (1) Oncology ERBB2
(HER2)
Indications and Usage, Adverse Reactions, Clinical Studies
  Fulvestrant (2) Oncology ESR, PGR
(Hormone Receptor)
Indications and Usage, Adverse Reactions, Clinical Pharmacology, Clinical Studies
  Futibatinib Oncology FGFR2 Indications and Usage, Dosage and Administration, Adverse Reactions, Clinical Studies
  Galantamine Neurology CYP2D6 Clinical Pharmacology
  Ganaxolone Neurology CDKL5 Indications and Usage, Clinical Studies
  Gefitinib (1) Oncology EGFR Indications and Usage, Dosage and Administration, Clinical Studies
  Gefitinib (2) Oncology CYP2D6 Clinical Pharmacology
  Gemtuzumab Ozogamicin Onoclogy CD33 Indications and Usage, Dosage and Administration, Adverse Reactions, Clinical Studies
  Gentamicin Infectious Diseases     MT-RNR1     Warnings
  Gilteritinib Oncology FLT3 Indications and Usage, Dosage and Administration, Clinical Studies
  Givosiran Gastroenterology CPOX, HMBS, PPOX
(Acute Hepatic Porphyria)
Clinical Studies
  Glimepiride Endocrinology G6PD Warnings and Precautions, Adverse Reactions
  Glipizide Endocrinology G6PD Precautions
  Glyburide Endocrinology G6PD Precautions
  Glycerol Phenylbutyrate (1) Inborn Errors of Metabolism ASS1, CPS1, OTC
(Urea Cycle Disorders)
Indications and Usage, Adverse Reactions, Clinical Studies
  Glycerol Phenylbutyrate (2) Inborn Errors of Metabolism NAGS Indications and Usage
  Golodirsen Neurology DMD Indications and Usage, Use in Specific Populations, Clinical Pharmacology, Clinical Studies
  Goserelin Oncology ESR, PGR
(Hormone Receptor)
Indications and Usage, Clinical Studies
  Hydralazine Cardiology Nonspecific
(NAT)
Clinical Pharmacology
  Hydroxychloroquine Infectious Diseases G6PD Warnings and Precautions, Adverse Reactions
  Ibrutinib (1) Oncology Chromosome 17p Indications and Usage, Clinical Studies
  Ibrutinib (2) Oncology Chromosome 11q Clinical Studies
  Ibrutinib (3) Oncology MYD88 Clinical Studies
  Iloperidone Psychiatry CYP2D6 Dosage and Administration, Warnings and Precautions, Drug Interactions, Clinical Pharmacology
  Imatinib (1) Oncology KIT Indications and Usage, Dosage and Administration, Clinical Studies
  Imatinib (2) Oncology BCR-ABL1
(Philadelphia chromosome)
Indications and Usage, Dosage and Administration, Warnings and Precautions, Adverse Reactions, Use in Specific Populations, Clinical Pharmacology, Clinical Studies
  Imatinib (3) Oncology PDGFRB Indications and Usage, Dosage and Administration, Clinical Studies
  Imatinib (4) Oncology FIP1L1-PDGFRA Indications and Usage, Dosage and Administration, Clinical Studies
  Imipramine Psychiatry CYP2D6 Precautions
  Inclisiran Endocrinology   Nonspecific
(Heterozygous Familial Hypercholesterolemia)
Indications and Usage, Clinical Studies
  Indacaterol Pulmonary UGT1A1 Clinical Pharmacology
  Inebilizumab-cdon Neurology AQP4 Indications and Usage, Clinical Studies
  Infigratinib Oncology FGFR2 Indications and Usage, Dosage and Administration, Clinical Studies
  Inotersen Neurology TTR Adverse Reactions, Clinical Pharmacology
  Inotuzumab Ozogamicin Oncology BCR-ABL1
(Philadelphia chromosome)
Clinical Studies
  Ipilimumab (1) Oncology HLA-A Clinical Studies
  Ipilimumab (2) Oncology Microsatellite Instability, Mismatch Repair Indications and Usage, Dosage and Administration, Warnings and Precautions, Adverse Reactions, Use in Specific Populations, Clinical Studies
  Ipilimumab (3) Oncology CD274
(PD-L1)
Indications and Usage, Dosage and Administration, Use in Specific Populations, Clinical Studies
  Ipilimumab (4) Oncology ALK Indications and Usage, Adverse Reactions, Clinical Studies
  Ipilimumab (5) Oncology EGFR Indications and Usage, Adverse Reactions, Clinical Studies
  Irinotecan Oncology UGT1A1 Dosage and Administration, Warnings and Precautions, Clinical Pharmacology
  Isatuximab- irfc (1) Oncology Chromosome 17p Clinical Studies
  Isatuximab- irfc (2) Oncology Chromosome 4p;14q Clinical Studies
  Isatuximab- irfc (3) Oncology Chromosome 14q;16q Clinical Studies
  Isoflurane Anesthesiology CACNA1S, RYR1 
(Genetic Susceptibility to Malignant Hyperthermia)
Contraindications, Warnings, Clinical Pharmacology
  Isoniazid, Pyrazinamide, and Rifampin Infectious Diseases Nonspecific
(NAT)
Clinical Pharmacology
  Isosorbide Dinitrate Cardiology CYB5R Overdosage
  Isosorbide Mononitrate Cardiology CYB5R Overdosage
  Ivacaftor Pulmonary CFTR Indications and Usage, Adverse Reactions, Use in Specific Populations, Clinical Pharmacology, Clinical Studies
  Ivacaftor and Lumacaftor Pulmonary CFTR Indications and Usage, Adverse Reactions, Use in Specific Populations, Clinical Studies
  Ivacaftor and Tezacaftor Pulmonary CFTR Indications and Usage, Adverse Reactions, Use in Specific Populations, Clinical Pharmacology, Clinical Studies
  Ivosidenib Oncology IDH1 Indications and Usage, Dosage and Administration, Clinical Pharmacology, Clinical Studies
  Ixabepilone (1) Oncology ERBB2
(HER2)
Clinical Studies
  Ixabepilone (2) Oncology ESR, PGR
(Hormone Receptor)
Clinical Studies
  Lacosamide Neurology CYP2C19 Clinical Pharmacology
  Lansoprazole Gastroenterology CYP2C19 Drug Interactions, Clinical Pharmacology
  Lapatinib (1) Oncology ERBB2
(HER2)
Indications and Usage, Dosage and Administration, Adverse Reactions, Use in Specific Populations, Clinical Studies
  Lapatinib (2) Oncology ESR, PGR
(Hormone Receptor)
Indications and Usage, Dosage and Administration, Adverse Reactions, Use in Specific Populations, Clinical Studies
  Lapatinib (3) Oncology HLA-DQA1 Clinical Pharmacology
  Lapatinib (4) Oncology HLA-DRB1 Clinical Pharmacology
  Larotrectinib Oncology NTRK Indications and Usage, Dosage and Administration, Adverse Reactions, Clinical Studies
  Lecanemab-irmb Neurology     APOE Boxed Warning, Warnings and Precautions, Clinical Studies, Patient Counseling Information
  Ledipasvir and Sofosbuvir Infectious Diseases IFNL3
(IL28B)
Clinical Studies
  Lenalidomide Hematology Chromosome 5q Boxed Warning, Indications and Usage, Adverse Reactions, Use in Specific Populations, Clinical Studies
  Leniolisib (1) Pulmonary     PIK3CD Clinical Studies
  Leniolisib (2) Pulmonary     PIK3R1 Clinical Studies
  Lenvatinib Oncology Microsatellite Instability, Mismatch Repair Indications and Usage, Adverse Reactions, Clinical Studies
  Lesinurad Rheumatology CYP2C9 Drug Interactions, Clinical Pharmacology
  Letrozole Oncology ESR, PGR
(Hormone Receptor)
Indications and Usage, Adverse Reactions, Clinical Studies
  Levothyroxine Endocrinology Nonspecific (Congenital Hypothyroidism) Indications and Usage, Warnings and Precautions, Use in Specific Populations
  Lidocaine and Prilocaine (1) Anesthesiology Nonspecific
(Congenital Methemoglobinemia)
Warnings and Precautions
  Lidocaine and Prilocaine (2) Anesthesiology G6PD Warnings and Precautions, Clinical Pharmacology
  Lidocaine and Tetracaine (1) Anesthesiology G6PD Warnings and Precautions
  Lidocaine and Tetracaine (2) Anesthesiology Nonspecific
(Congenital Methemoglobinemia)
Warnings and Precautions
  Lofexidine Anesthesiology CYP2D6 Use in Specific Populations
  Lomitapide Endocrinology Nonspecific
(Homozygous Familial Hypercholesterolemia)
Indications and Usage, Warnings and Precautions, Adverse Reactions, Clinical Studies
  Lonafarnib (1) Inborn Errors of Metabolism LMNA Indications and Usage, Adverse Reactions, Use in Specific Populations, Clinical Studies
  Lonafarnib (2) Inborn Errors of Metabolism ZMPSTE24 Indications and Usage, Use in Specific Populations
  Lorlatinib (1) Oncology ALK Indications and Usage, Dosage and Administration, Adverse Reactions, Clinical Studies
  Lorlatinib (2) Oncology ROS1 Adverse Reactions
  Lumasiran Urology AGXT Indications and Usage, Adverse Reactions, Use in Specific Populations, Clinical Pharmacology, Clinical Studies
  Luspatercept–aamt Hematology HBB Clinical Studies
  Lusutrombopag (1) Hematology F2
(Prothrombin)
Warnings and Precautions
  Lusutrombopag (2) Hematology F5
(Factor V Leiden)
Warnings and Precautions
  Lusutrombopag (3) Hematology PROC Warnings and Precautions
  Lusutrombopag (4) Hematology PROS1 Warnings and Precautions
  Lusutrombopag (5) Hematology SERPINC1
(Antithrombin III)
Warnings and Precautions
  Lutetium Lu 177 Dotatate Oncology SSTR  Indications and Usage, Adverse Reactions, Clinical Pharmacology, Clinical Studies
  Lutetium Lu 177 Vipivotide Tetraxetan Oncology FOLH1
(PSMA)
Indications and Usage, Dosage and Administration, Adverse Reactions, Clinical Studies
  Mafenide Infectious Diseases G6PD Warnings, Adverse Reactions
  Maralixibat Gastroenterology JAG1 Clinical Studies
  Margetuximab-cmkb (1) Oncology ERBB2
(HER2)
Indications and Usage, Adverse Reactions, Clinical Pharmacology, Clinical Studies
  Margetuximab-cmkb (2) Oncology FCGR2A
(CD32A)
Clinical Pharmacology
  Margetuximab-cmkb (3) Oncology FCGR2B
(CD32B)
Clinical Pharmacology
  Margetuximab-cmkb (4) Oncology FCGR3A
(CD16A)
Clinical Pharmacology
  Mavacamten Cardiology CYP2C19 Dosage and Administration, Clinical Pharmacology
  Meclizine Neurology CYP2D6 Warnings and Precautions
  Meloxicam Anesthesiology CYP2C9 Use in Specific Populations, Clinical Pharmacology
  Mepivacaine (1) Anesthesiology G6PD Warnings
  Mepivacaine (2) Anesthesiology Nonspecific
(Congenital Methemoglobinemia)
Warnings
  Mepolizumab Oncology     FIP1L1-PDGFRA     Adverse Reactions, Clinical Studies
  Mercaptopurine (1) Oncology TPMT Dosage and Administration, Warnings and Precautions, Adverse Reactions, Clinical Pharmacology
  Mercaptopurine (2) Oncology NUDT15 Dosage and Administration, Warnings and Precautions, Clinical Pharmacology
  Methylene Blue Hematology G6PD Contraindications, Warnings and Precautions
  Metoclopramide (1) Gastroenterology CYB5R Use in Specific Populations
  Metoclopramide (2) Gastroenterology G6PD Use in Specific Populations, Overdosage
  Metoclopramide (3) Gastroenterology CYP2D6 Dosage and Administration, Use in Specific Populations, Clinical Pharmacology
  Metoprolol Cardiology CYP2D6 Clinical Pharmacology
  Metreleptin Endocrinology LEP Contraindications
  Midostaurin (1) Oncology FLT3 Indications and Usage, Dosage and Administration, Adverse Reactions, Clinical Studies
  Midostaurin (2) Oncology NPM1 Clinical Studies
  Midostaurin (3) Oncology KIT Clinical Studies
  Migalastat Inborn Errors of Metabolism GLA Indications and Usage, Dosage and Administration, Clinical Pharmacology, Clinical Studies
  Mirabegron Urology CYP2D6 Clinical Pharmacology
  Mirvetuximab Soravtansine-gynx Oncology FOLR1 Indications and Usage, Dosage and Administration, Clinical Studies
  Mitapivat Hematology PKLR Clinical Studies
  Mivacurium Anesthesiology BCHE Warnings, Precautions, Clinical Pharmacology
  Mobocertinib Oncology EGFR Indications and Usage, Dosage and Administration, Adverse Reactions, Clinical Studies
  Modafinil Psychiatry CYP2D6 Clinical Pharmacology
  Mycophenolic Acid Transplantation HPRT1 Warnings and Precautions
  Nalidixic Acid Infectious Diseases G6PD Precautions, Adverse Reactions
  Nateglinide Endocrinology CYP2C9 Drug Interactions
  Nebivolol Cardiology CYP2D6 Dosage and Administration, Clinical Pharmacology
  Nedosiran Nephrology AGXT Indications and Usage, Adverse Reactions, Use in Specific Populations, Clinical Pharmacology, Clinical Studies
  Nefazodone Psychiatry CYP2D6 Precautions
  Neomycin Infectious Diseases   MT-RNR1     Warnings
  Neratinib (1) Oncology ERBB2
(HER2)

Indications and Usage, Adverse Reactions, Clinical Studies

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

Clinical Studies

  Nilotinib (1) Oncology BCR-ABL1
(Philadelphia chromosome)
Indications and Usage, Dosage and Administration, Warnings and Precautions, Adverse Reactions, Use in Specific Populations, Clinical Pharmacology, Clinical Studies
  Nilotinib (2) Oncology UGT1A1 Clinical Pharmacology
  Niraparib Oncology BRCA (Homologous Recombination Deficiency) Indications and Usage, Dosage and Administration, Clinical Studies
  Nitrofurantoin Infectious Diseases G6PD Warnings, Adverse Reactions
  Nirogacestat (1) Oncology APC Clinical Studies
  Nirogacestat (2) Oncology CTNNB1 Clinical Studies
  Nivolumab (1) Oncology BRAF Adverse Reactions, Clinical Studies
  Nivolumab (2) Oncology CD274
(PD-L1)
Indications and Usage, Dosage and Administration, Use in Specific Populations, Clinical Pharmacology, Clinical Studies
  Nivolumab (3) Oncology Microsatellite Instability, Mismatch Repair Indications and Usage, Clinical Studies
  Nivolumab (4) Oncology EGFR Indications and Usage, Adverse Reactions, Clinical Studies
  Nivolumab (5) Oncology ALK Indications and Usage, Adverse Reactions, Clinical Studies
  Nivolumab (6) Oncology ERBB2
(HER2)
Adverse Reactions, Clinical Studies
  Nivolumab and Relatlimab-rmbw (1) Oncology BRAF Clinical Studies
  Nivolumab and Relatlimab-rmbw (2) Oncology CD274
(PD-L1)
Clinical Studies
  Nivolumab and Relatlimab-rmbw (3) Oncology LAG3 Clinical Studies
  Nortriptyline Psychiatry CYP2D6 Precautions
  Nusinersen Neurology SMN2 Clinical Pharmacology, Clinical Studies
  Obinutuzumab Oncology MS4A1
(CD20 antigen)
Clinical Studies
  Odevixibat (1) Gastroenterology ABCB11 Indications and Usage, Clinical Pharmacology, Clinical Studies
  Odevixibat (2)
 
Gastroenterology    ATP8B1     Indications and Usage, Clinical Pharmacology, Clinical Studies
  Odevixibat (3) Gastroenterology     JAG1     Clinical Studies
  Odevixibat (4) Gastroenterology     NOTCH2     Clinical Studies
  Olaparib (1) Oncology BRCA Indications and Usage, Dosage and Administration, Warnings and Precautions, Adverse Reactions, Clinical Studies
  Olaparib (2) Oncology ERBB2
(HER2)
Indications and Usage, Dosage and Administration, Adverse Reactions, Clinical Studies
  Olaparib (3) Oncology ESR, PGR
(Hormone Receptor)

Indications and Usage, Clinical Studies

  Olaparib (4) Oncology BRCA, Genomic Instability (Homologous Recombination Deficiency) Indications and Usage, Dosage and Administration, Adverse Reactions, Clinical Studies
  Olaparib (5) Oncology Homologous Recombination Repair Indications and Usage, Dosage and Administration, Adverse Reactions, Clinical Studies
  Olaparib (6) Oncology PPP2R2A Clinical Studies
  Olaratumab Oncology PDGFRA Clinical Studies
  Oliceridine Anesthesiology CYP2D6 Warnings and Precautions, Drug Interactions, Use in Specific Populations, Clinical Pharmacology
  Olutasidenib Oncology IDH1 Indications and Usage, Dosage and Administration, Adverse Reactions, Use in Specific Populations, Clinical Pharmacology, Clinical Studies
  Omacetaxine Oncology BCR-ABL1
(Philadelphia chromosome)
Clinical Studies
  Ombitasvir, Paritaprevir, and Ritonavir Infectious Diseases IFNL3
(IL28B)
Clinical Studies
  Omeprazole Gastroenterology CYP2C19 Drug Interactions, Clinical Pharmacology
  Oxymetazoline and Tetracaine (1) Anesthesiology G6PD Warnings and Precautions
  Oxymetazoline and Tetracaine (2) Anesthesiology Nonspecific
(Congenital Methemoglobinemia)
Warnings and Precautions
  Ondansetron Gastroenterology CYP2D6 Clinical Pharmacology
  Osimertinib Oncology EGFR Indications and Usage, Dosage and Administration, Adverse Reactions, Clinical Studies
  Ospemifene (1) Gynecology CYP2C9 Clinical Pharmacology
  Ospemifene (2) Gynecology CYP2B6 Clinical Pharmacology
  Oxcarbazepine Neurology HLA-B Warnings and Precautions
  Palbociclib (1) Oncology ESR
(Hormone Receptor)
Indications and Usage, Adverse Reactions, Clinical Studies
  Palbociclib (2) Oncology ERBB2
(HER2)
Indications and Usage, Adverse Reactions, Clinical Studies
  Paliperidone Psychiatry CYP2D6 Clinical Pharmacology
  Palonosetron Gastroenterology CYP2D6 Clinical Pharmacology
  Panitumumab (1) Oncology EGFR Adverse Reactions, Clinical Pharmacology, Clinical Studies
  Panitumumab (2) Oncology RAS Indications and Usage, Dosage and Administration, Warnings and Precautions, Adverse Reactions, Clinical Studies
  Pantoprazole Gastroenterology CYP2C19 Clinical Pharmacology
  Parathyroid Hormone Inborn Errors of Metabolism CASR Indications and Usage, Clinical Studies
  Paroxetine Psychiatry CYP2D6 Drug Interactions, Clinical Pharmacology
  Patisiran Neurology TTR Adverse Reactions, Clinical Pharmacology, Clinical Studies
  Pazopanib (1) Oncology UGT1A1 Clinical Pharmacology
  Pazopanib (2) Oncology HLA-B Clinical Pharmacology
  Peginterferon Alfa-2b Infectious Diseases IFNL3
(IL28B)
Clinical Pharmacology
  Pegloticase Rheumatology G6PD Boxed Warning, Contraindications, Warnings and Precautions, Adverse Reactions, Patient Counseling Information
  Pembrolizumab (1) Oncology BRAF Adverse Reactions, Clinical Studies
  Pembrolizumab (2) Oncology CD274
(PD-L1)
Indications and Usage, Dosage and Administration, Adverse Reactions, Use in Specific Populations, Clinical Studies
  Pembrolizumab (3) Oncology Microsatellite Instability, Mismatch Repair Indications and Usage, Dosage and Administration, Adverse Reactions, Use in Specific Populations, Clinical Studies  
  Pembrolizumab (4) Oncology EGFR Indications and Usage, Adverse Reactions, Clinical Studies
  Pembrolizumab (5) Oncology ALK Indications and Usage, Adverse Reactions, Clinical Studies
  Pembrolizumab (6) Oncology Tumor Mutational Burden Indications and Usage, Dosage and Administration, Clinical Studies
  Pembrolizumab (7) Oncology ERBB2
(HER2)
Indications and Usage, Adverse Reactions, Clinical Studies
  Pemetrexed (1) Oncology ALK Indications and Usage, Adverse Reactions, Clinical Studies
  Pemetrexed (2) Oncology EGFR Indications and Usage, Adverse Reactions, Clinical Studies
  Pemetrexed (3) Oncology CD274
(PD-L1)
Clinical Studies
  Pemigatinib (1) Oncology FGFR1 Indications and Usage, Dosage and Administration, Adverse Reactions, Use in Specific Populations, Clinical Studies
  Pemigatinib (2) Oncology FGFR2 Indications and Usage, Dosage and Administration, Clinical Studies
  Perphenazine Psychiatry CYP2D6 Precautions, Clinical Pharmacology
  Pertuzumab (1) Oncology ERBB2
(HER2)
Indications and Usage, Dosage and Administration, Warnings and Precautions, Adverse Reactions, Clinical Pharmacology, Clinical Studies
  Pertuzumab (2) Oncology ESR, PGR
(Hormone Receptor)
Clinical Studies
  Phenytoin (1) Neurology CYP2C9 Warnings and Precautions, Use in Specific Populations, Clinical Pharmacology
  Phenytoin (2) Neurology CYP2C19 Clinical Pharmacology
  Phenytoin (3) Neurology HLA-B Warnings and Precautions
  Pimozide Psychiatry CYP2D6 Dosage and Administration, Precautions
  Piroxicam Rheumatology CYP2C9 Clinical Pharmacology
  Pirtobrutinib (1) Oncology BTK Clinical Studies
  Pirtobrutinib (2) Oncology Chromosome 11q Clinical Studies
  Pirtobrutinib (3) Oncology Chromosome 17p Clinical Studies
  Pirtobrutinib (4) Oncology IGHV Clinical Studies
  Pirtobrutinib (5) Oncology TP53 Clinical Studies
  Pitolisant Psychiatry CYP2D6 Dosage and Administration, Use in Specific Populations, Clinical Pharmacology
  Plazomicin Infectious Diseases     MT-RNR1   Warnings and Precautions
  Polatuzumab Vedotin-piiq (1) Oncology   BCL2     Clinical Studies
  Polatuzumab Vedotin-piiq (2) Oncology     BCL6     Clinical Studies
  Polatuzumab Vedotin-piiq (3) Oncology     MYC     Clinical Studies
  Ponatinib Oncology BCR-ABL1
(Philadelphia chromosome)
Indications and Usage, Warnings and Precautions, Adverse Reactions, Use in Specific Populations, Clinical Studies
  Pralsetinib Oncology CCDC6-RET, KIF5B-RET,  RET Indications and Usage, Dosage and Administration, Adverse Reactions, Use in Specific Populations, Clinical Pharmacology, Clinical Studies
  Prasugrel (1) Cardiology CYP2C19 Use in Specific Populations, Clinical Pharmacology, Clinical Studies
  Prasugrel (2) Cardiology CYP2C9 Use in Specific Populations, Clinical Pharmacology, Clinical Studies
  Prasugrel (3) Cardiology CYP3A5 Use in Specific Populations, Clinical Pharmacology, Clinical Studies
  Prasugrel (4) Cardiology CYP2B6 Use in Specific Populations, Clinical Pharmacology, Clinical Studies
  Primaquine (1) Infectious Diseases G6PD Contraindications, Warnings, Precautions, Adverse Reactions, Overdosage
  Primaquine (2)  Infectious Diseases CYB5R Precautions, Adverse Reactions
  Probenecid Rheumatology G6PD Adverse Reactions
  Procainamide Cardiology Nonspecific
(NAT)
Adverse Reactions, Clinical Pharmacology
  Propafenone Cardiology CYP2D6 Dosage and Administration, Warnings and Precautions, Drug Interactions, Clinical Pharmacology
  Propranolol Cardiology CYP2D6 Clinical Pharmacology
  Protriptyline Psychiatry CYP2D6 Precautions
  Quinidine Cardiology CYP2D6 Precautions
  Quinine Sulfate (1) Infectious Diseases G6PD Warnings and Precautions
  Quinine Sulfate (2) Infectious Diseases CYP2D6 Drug Interactions
  Quizartinib Oncology FLT3 Indications and Usage, Dosage and Administration, Warnings and Precautions, Adverse Reactions, Clinical Studies
  Rabeprazole Gastroenterology CYP2C19 Drug Interactions, Clinical Pharmacology
  Raloxifene Oncology ESR
(Hormone Receptor)
Clinical Studies
  Raltegravir Infectious Diseases UGT1A1 Clinical Pharmacology
  Ramucirumab (1) Oncology EGFR Indications and Usage, Dosage and Administration, Adverse Reactions, Clinical Studies
  Ramucirumab (2) Oncology RAS Clinical Studies
  Rasburicase (1) Oncology G6PD Boxed Warning, Contraindications, Warnings and Precautions
  Rasburicase (2) Oncology CYB5R Boxed Warning, Contraindications, Warnings and Precautions
  Ravulizumab-cwvz Neurology ACHR Indications and Usage, Clinical Studies
  Regorafenib Oncology RAS Indications and Usage, Clinical Studies
  Repotrectinib Oncology ROS1 Indications and Usage, Dosage and Administration, Adverse Reactions, Use in Specific Populations, Clinical Studies
  Ribociclib (1) Oncology ESR, PGR (Hormone Receptor) Indications and Usage, Adverse Reactions, Clinical Studies
  Ribociclib (2) Oncology ERBB2
(HER2)
Indications and Usage, Adverse Reactions, Clinical Studies
  Rimegepant Neurology CYP2C9 Clinical Pharmacology
  Risdiplam Neurology SMN1, SMN2 Clinical Studies
  Risperidone Psychiatry CYP2D6 Clinical Pharmacology
  Rituximab Oncology MS4A1
(CD20 antigen)
Indications and Usage, Dosage and Administration, Adverse Reactions, Use in Specific Populations, Clinical Studies
  Rivaroxaban Cardiology F5
(Factor V Leiden)
Clinical Studies
  Ropeginterferon Alfa-2b-njft Hematology JAK2 Clinical Pharmacology, Clinical Studies
  Ropivacaine (1) Anesthesiology G6PD Warnings
  Ropivacaine (2) Anesthesiology Nonspecific
(Congenital Methemoglobinemia)
Warnings
  Rosuvastatin Endocrinology SLCO1B1 Clinical Pharmacology
  Rozanolixizumab-noli (1) Neurology     ACHR Indications and Usage, Clinical Pharmacology, Clinical Studies
  Rozanolixizumab-noli (2) Neurology     MUSK     Indications and Usage, Clinical Pharmacology, Clinical Studies
  Rucaparib (1) Oncology BRCA Indications and Usage, Dosage and Administration, Adverse Reactions, Clinical Studies
  Rucaparib (2) Oncology CYP2D6 Clinical Pharmacology
  Rucaparib (3) Oncology CYP1A2 Clinical Pharmacology
  Rucaparib (4) Oncology BRCA, Loss of Heterozygosity (Homologous Recombination Deficiency) Warnings and Precautions, Adverse Reactions, Clinical Studies
  Sacituzumab Govitecan-hziy (1) Oncology UGT1A1 Warnings and Precautions, Clinical Pharmacology
  Sacituzumab Govitecan-hziy (2) Oncology     BRCA     Clinical Studies
  Sacituzumab Govitecan-hziy (3) Oncology     ESR
(Hormone Receptor)  
 Indications and Usage, Adverse Reactions, Use in Specific Populations, Clinical Studies
  Sacituzumab Govitecan-hziy (4) Oncology     ERBB2
(HER2)    
Indications and Usage, Adverse Reactions, Use in Specific Populations, Clinical Studies
  Sacrosidase Inborn Errors of Metabolism Nonspecific
(Congenital Sucrase-Isomaltase Deficiency)
Indications and Usage, Adverse Reactions, Clinical Pharmacology
  Satralizumab-mwge Neurology AQP4 Indications and Usage, Adverse Reactions, Clinical Studies
  Selpercatinib Oncology RET Indications and Usage, Dosage and Administration, Adverse Reactions, Use in Specific Populations, Clinical Studies
  Setmelanotide (1) Endocrinology LEPR Indications and Usage, Dosage and Administration, Adverse Reactions, Use in Specific Populations, Clinical Studies
  Setmelanotide (2) Endocrinology PCSK1 Indications and Usage, Dosage and Administration, Adverse Reactions, Use in Specific Populations, Clinical Studies
  Setmelanotide (3) Endocrinology POMC Indications and Usage, Dosage and Administration, Adverse Reactions, Use in Specific Populations, Clinical Studies
  Sevoflurane Anesthesiology CACNA1S, RYR1 
(Genetic Susceptibility to Malignant Hyperthermia)
Contraindications, Warnings, Clinical Pharmacology
  Simeprevir Infectious Diseases IFNL3
(IL28B)
Clinical Pharmacology, Clinical Studies
  Siponimod Neurology CYP2C9 Dosage and Administration, Contraindications, Drug Interactions, Use in Specific Populations, Clinical Pharmacology
  Sodium Nitrite (1) Toxicology G6PD Warnings and Precautions
  Sodium Nitrite (2) Toxicology Nonspecific
(Congenital Methemoglobinemia)
Boxed Warning, Warnings and Precautions
  Sodium Oxybate Neurology ALDH5A1
(Succinic Semialdehyde Dehydrogenase Deficiency)
Contraindications
  Sodium Phenylbutyrate Inborn Errors of Metabolism ASS1, CPS1, OTC
(Urea Cycle Disorders)
Indications and Usage, Dosage and Administration, Adverse Reactions, Clinical Pharmacology
  Sofosbuvir Infectious Diseases IFNL3
(IL28B)
Clinical Studies
  Sofosbuvir and Velpatasvir Infectious Diseases IFNL3
(IL28B)
Clinical Studies
  Sofosbuvir, Velpatasvir, and Voxilaprevir Infectious Diseases IFNL3
(IL28B)
Clinical Studies
  Sotorasib Oncology KRAS Indication and Usage, Dosage and Administration, Adverse Reactions, Clinical Pharmacology, Clinical Studies
  Streptomycin Infectious Diseases     MT-RNR1     Warnings
  Succimer Hematology G6PD Clinical Pharmacology
  Succinylcholine (1) Anesthesiology BCHE Warnings, Precautions
  Succinylcholine (2) Anesthesiology

CACNA1S, RYR1 
(Genetic Susceptibility to Malignant Hyperthermia)

Boxed Warning, Contraindications, Warnings, Precautions, Adverse Reactions, Clinical Pharmacology
  Sulfadiazine Infectious Diseases G6PD Warnings
  Sulfamethoxazole and Trimethoprim (1) Infectious Diseases G6PD Precautions
  Sulfamethoxazole and Trimethoprim (2) Infectious Diseases Nonspecific
(NAT)
Precautions
  Sulfasalazine (1) Gastroenterology G6PD Precautions
  Sulfasalazine (2) Gastroenterology Nonspecific
(NAT)
Clinical Pharmacology
  Synthetic Conjugated Estrogens, A (1) Gynecology PROC Contraindications
  Synthetic Conjugated Estrogens, A (2) Gynecology PROS1 Contraindications
  Synthetic Conjugated Estrogens, A (3) Gynecology SERPINC1
(Antithrombin III)
Contraindications
  Tafamidis Cardiology TTR Clinical Pharmacology, Clinical Studies
  Tafenoquine Infectious Diseases G6PD Dosage and Administration, Contraindications, Warnings and Precautions, Use in Specific Populations, Patient Counseling Information
  Talazoparib (1) Oncology BRCA Indications and Usage, Dosage and Administration, Adverse Reactions, Clinical Studies
  Talazoparib (2) Oncology ERBB2
(HER2)
Indications and Usage, Adverse Reactions, Clinical Studies
  Talazoparib (3) Oncology    
 
Homologous Recombination Repair     Indications and Usage, Dosage and Administrations, Adverse Reactions, Drug Interactions, Clinical Studies
  Tamoxifen (1) Oncology ESR, PGR
(Hormone Receptor)
Indications and Usage, Adverse Reactions, Clinical Pharmacology, Clinical Studies
  Tamoxifen (2) Oncology F5
(Factor V Leiden)
Warnings and Precautions
  Tamoxifen (3) Oncology F2
(Prothrombin)
Warnings and Precautions
  Tamoxifen (4) Oncology CYP2D6 Clinical Pharmacology
  Tamsulosin Urology CYP2D6 Warnings and Precautions, Adverse Interactions, Clinical Pharmacology
  Tebentafusp-tebn Oncology HLA-A Indications and Usage, Dosage and Administration, Clinical Studies
  Teclistamab-cqyv (1) Oncology Chromosome 17p Clinical Studies 
  Teclistamab-cqyv (2) Oncology Chromosome 4p;14q Clinical Studies 
  Teclistamab-cqyv (3) Oncology Chromosome 14q;16q Clinical Studies 
  Telaprevir Infectious Diseases IFNL3
(IL28B)
Clinical Pharmacology, Clinical Studies
  Tepotinib (1) Oncology ALK Clinical Studies
  Tepotinib (2) Oncology EGFR Clinical Studies
  Tepotinib (3) Oncology MET Indications and Usage, Dosage and Administration, Adverse Reactions, Use in Specific Populations, Clinical Studies
  Tetrabenazine Neurology CYP2D6 Dosage and Administration, Warnings and Precautions, Use in Specific Populations, Clinical Pharmacology
  Thioguanine (1) Oncology TPMT Dosage and Administration, Warnings, Precautions, Clinical Pharmacology
  Thioguanine (2) Oncology NUDT15 Dosage and Administration, Warnings, Precautions, Clinical Pharmacology
  Thioridazine  Psychiatry CYP2D6 Contraindications, Warnings, Precautions
  Ticagrelor Cardiology CYP2C19 Clinical Pharmacology
  Tipiracil and Trifluridine (1) Oncology ERBB2
(HER2)
Indications and Usage, Adverse Reactions, Clinical Studies
  Tipiracil and Trifluridine (2) Oncology RAS Indications and Usage, Clinical Studies
  Tobramycin Infectious Diseases     MT-RNR1     Warnings and Precautions
  Tofersen Oncology     SOD1 Indications and Usage, Use in Specific Populations, Clinical Studies
  Tolazamide Endocrinology G6PD Precautions
  Tolbutamide Endocrinology G6PD Precautions
  Tolterodine Urology CYP2D6 Warnings and Precautions, Drug Interactions, Clinical Pharmacology
  Toremifene Oncology ESR
(Hormone Receptor)
Indications and Usage, Clinical Studies
  Tramadol Anesthesiology CYP2D6 Boxed Warning, Warnings and Precautions, Use in Specific Populations, Clinical Pharmacology, Patient Counseling Information
  Trametinib (1) Oncology BRAF Indications and Usage, Dosage and Administration, Adverse Reactions, Use in Specific Populations, Clinical Pharmacology, Clinical Studies
  Trametinib (2) Oncology G6PD Adverse Reactions
  Trametinib (3) Oncology RAS Warnings and Precautions
  Trastuzumab (1) Oncology ERBB2
(HER2)
Indications and Usage, Dosage and Administration, Clinical Pharmacology, Clinical Studies
  Trastuzumab (2) Oncology ESR, PGR
(Hormone Receptor)
Clinical Studies
  Tretinoin Oncology PML-RARA Indications and Usage, Dosage and Administration, Warnings and Precautions, Patient Counseling Information
  Triheptanoin Inborn Errors of Metabolism ACADVL, CPT2, HADHA, HADHB (Long-Chain Fatty Acid Oxidation Disorders) Indications and Usage, Clinical Studies
  Tremelimumab-actl (1) Oncology ALK Indications and Usage, Clinical Studies
  Tremelimumab-actl (2) Oncology EGFR Indications and Usage, Clinical Studies
  Tremelimumab-actl (3) Oncology CD274
(PD-L1)
Clinical Studies
  Trimipramine Psychiatry CYP2D6 Precautions
  Trofinetide Neurology     MECP2 Clinical Studies
  Tucatinib (1) Oncology ERBB2
(HER2)
Indications and Usage, Dosage and Administration, Adverse Reactions, Clinical Studies
  Tucatinib (2) Oncology  Microsatellite Instability, Mismatch Repair     Indications and Usage, Dosage and Administration, Adverse Reactions, Clinical Studies
  Tucatinib (3) Oncology     RAS     Clinical Studies
  Umeclidinium Pulmonary CYP2D6 Clinical Pharmacology
  Upadacitinib Rheumatology CYP2D6 Clinical Pharmacology
  Ustekinumab Dermatology and Gastroenterology IL12A, IL12B, IL23A Warnings and Precautions
  Valbenazine Neurology CYP2D6 Dosage and Administration, Warnings and Precautions, Use in Specific Populations, Clinical Pharmacology
  Valproic Acid (1) Neurology POLG Boxed Warning, Contraindications, Warnings and Precautions
  Valproic Acid (2) Neurology Nonspecific
(Urea Cycle Disorders)
Contraindications, Warnings and Precautions
  Vemurafenib (1) Oncology BRAF Indications and Usage, Dosage and Administration, Warnings and Precautions, Adverse Reactions, Use in Specific Populations, Clinical Pharmacology, Clinical Studies, Patient Counseling Information
  Vemurafenib (2) Oncology RAS Warnings and Precautions, Adverse Reactions
  Venetoclax (1) Oncology Chromosome 17p Clinical Studies
  Venetoclax (2) Oncology Chromosome 11q Clinical Studies
  Venetoclax (3) Oncology TP53 Clinical Studies
  Venetoclax (4) Oncology IDH1 Clinical Studies
  Venetoclax (5) Oncology IDH2 Clinical Studies
  Venetoclax (6) Oncology IGHV Clinical Studies
  Venetoclax (7) Oncology NPM1 Clinical Studies
  Venetoclax (8) Oncology FLT3 Clinical Studies
  Venlafaxine Psychiatry CYP2D6 Drug Interactions, Use in Specific Populations, Clinical Pharmacology
  Viloxazine (1) Psychiatry CYP2D6 Clinical Pharmacology
  Viloxazine (2) Psychiatry SLCO1B1 Clinical Pharmacology
  Viltolarsen Neurology DMD Indications and Usage, Adverse Reactions, Use in Specific Populations, Clinical Pharmacology, Clinical Studies
  Vincristine Oncology BCR-ABL1
(Philadelphia chromosome)
Indications and Usage, Adverse Reactions, Clinical Studies
  Voriconazole Infectious Diseases CYP2C19 Clinical Pharmacology
  Vortioxetine Psychiatry CYP2D6 Dosage and Administration, Clinical Pharmacology
  Voxelotor Hematology HBB Clinical Pharmacology, Clinical Studies
  Vutrisiran Neurology TTR Adverse Reactions, Clinical Pharmacology, Clinical Studies
  Warfarin (1) Hematology CYP2C9 Dosage and Administration, Drug Interactions, Clinical Pharmacology
  Warfarin (2) Hematology VKORC1 Dosage and Administration, Clinical Pharmacology
  Warfarin (3) Hematology PROS1 Warnings and Precautions
  Warfarin (4) Hematology PROC Warnings and Precautions
  Zanubrutinib (1) Oncology MYD88 Adverse Reactions, Clinical Studies
  Zanubrutinib (2) Oncology     Chromosome 17p    Adverse Reactions, Clinical Studies
  Zanubrutinib (3) Oncology     TP53     Clinical Studies
  Zilucoplan Neurology ACHR Indications and Usage, Clinical Studies
 * 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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