FARMACO-Table of Pharmacogenomic Biomarkers in Drug Labeling - FDA

23/02/2024, 20:28 Table of Pharmacogenomic Biomarkers in Drug Labeling | FDA
Table of Pharmacogenomic Biomarkers in Drug Labeling
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FDA CDER Genomics pharmacogenomics@fda.hhs.gov (mailto:pharmacogenomics@fda.hhs.gov)
Division of Translational and Precision Medicine (DTPM) (/about-fda/center-drug-evaluation-and-research-cder/division-
translational-and-precision-medicine-dtpm)
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 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm) 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
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Pharmacogenomic Biomarkers in Drug Labeling
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 Drug  Therapeutic Area*  Biomarker†  Labeling Sections 
Abacavir Infectious Diseases HLA-B Boxed Warning,

(http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm? Dosage and
event=overview.process&varApplNo=020977) Administration,
Contraindications,
Warnings and
Precautions
Abemaciclib (1) Oncology ESR Indications and Usage,

(http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm? (Hormone Receptor) Adverse Reactions,
event=overview.process&varApplNo=208716) Clinical Studies
Abemaciclib (2) Oncology ERBB2 Indications and Usage,

(http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm? (HER2) Adverse Reactions, 
event=overview.process&varApplNo=208716) Clinical Studies Top ()
https://www.fda.gov/drugs/science-and-research-drugs/table-pharmacogenomic-biomarkers-drug-labeling 1/41
Abemaciclib (3) Oncology MKI67 Clinical Studies

(http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=overview.process&varApplNo=208716)
Abrocitinib Dermatology CYP2C19 Dosage and

(http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm? Administration, Use in
event=overview.process&varApplNo=213871) Specific Populations,
Clinical Pharmacology
Adagrasib Oncology KRAS Indications and Usage,

event=overview.process&varApplNo=216340) Administration, Adverse
Reactions, Clinical
Pharmacology, Clinical
Studies
Ado-Trastuzumab Emtansine Oncology ERBB2 Indications and Usage,

(http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm? (HER2) Dosage and
Reactions, Clinical
Studies
Aducanumab-avwa Neurology APOE Warnings and

(http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm? Precautions, Clinical
event=overview.process&varApplNo=761178) Studies
Afatinib Oncology EGFR Indications and Usage,

Reactions, Clinical
Studies
Alectinib Oncology ALK Indications and Usage,

Reactions, Clinical
Studies
Alglucosidase Alfa Inborn Errors of GAA Warnings and

(http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm? Metabolism Precautions
Allopurinol Oncology HLA-B Warnings

Alpelisib (1) Oncology ERBB2 Indication and Usage,

Reactions, Clinical
Studies
Alpelisib (2) Oncology ESR Indication and Usage,

(http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm? (Hormone Receptor) Dosage and
Reactions, Clinical
Studies
Alpelisib (3) Oncology PIK3CA Indication and Usage,

Reactions, Clinical
Studies
Amifampridine Neurology NAT2 Dosage and

(http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm? Administration, Adverse
event=overview.process&varApplNo=209321) Reactions, Use in
Specific Populations,

Top ()
Amifampridine Phosphate Neurology NAT2 Dosage and

Amikacin Infectious Diseases MT-RNR1 Warnings and

(http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm? Precautions
Amitriptyline Psychiatry CYP2D6 Precautions

Amivantamab-vmjw Oncology EGFR Indications and Usage,

Reactions, Clinical
Studies
Amoxapine Psychiatry CYP2D6 Precautions

Amphetamine Psychiatry CYP2D6 Clinical Pharmacology

Anakinra Rheumatology NLRP3 Indications and Usage,

Warnings and
Precautions, Adverse
Reactions, Use in
Clinical Pharmacology,
Clinical Studies
Anastrozole Oncology ESR, PGR Indications and Usage,

event=overview.process&varApplNo=020541) Drug Interactions,
Clinical Studies
Anifrolumab-fnia Rheumatology Gene Signature Clinical Pharmacology,

(http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm? (IFN) Clinical Studies
Arformoterol (1) Pulmonary UGT1A1 Clinical Pharmacology

Arformoterol (2) Pulmonary CYP2D6 Clinical Pharmacology

Aripiprazole Psychiatry CYP2D6 Dosage and

Aripiprazole Lauroxil Psychiatry CYP2D6 Dosage and

Arsenic Trioxide Oncology PML-RARA Indications and Usage,

(http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm? Clinical Studies
Articaine and Epinephrine (1) Anesthesiology G6PD Warnings and


Top ()
Articaine and Epinephrine (2) Anesthesiology Nonspecific Warnings and

(http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm? (Congenital Precautions
event=overview.process&varApplNo=022466) Methemoglobinemia)
Asciminib Oncology BCR-ABL1 Indications and Usage,

(http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm? (Philadelphia Dosage and
event=overview.process&varApplNo=215358) chromosome) Administration, Adverse
Reactions, Use in
Clinical Studies
Ascorbic Acid Endocrinology G6PD Dosage and

(http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm? Administration,
event=overview.process&varApplNo=209112) Warnings and
Reactions, Patient
Counseling Information
Atezolizumab (1) Oncology CD274 Indications and Usage,

(http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm? (PD-L1) Dosage and
Reactions, Clinical
Studies
Atezolizumab (2) Oncology Gene Signature Clinical Studies

(http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm? (T-effector)
Atezolizumab (3) Oncology EGFR Indications and Usage,

(http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm? Adverse Reactions,
Atezolizumab (4) Oncology ALK Indications and Usage,

Atezolizumab (5) Oncology BRAF Indications and Usage,

Reactions, Clinical
Studies
Atomoxetine Psychiatry CYP2D6 Dosage and

Reactions, Drug
Interactions, Use in
Ascorbic Acid, PEG-3350, Potassium Chloride, Sodium Gastroenterology G6PD Warnings and
Ascorbate, Sodium Chloride, and Sodium Sulfate Precautions, Adverse
(http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm? Reactions
Avapritinib (1) Oncology PDGFRA Indications and Usage,

event=overview.process&varApplNo=212608) Administration, Clinical
Studies
Avapritinib (2) Oncology KIT Clinical Studies

Avatrombopag (1) Hematology F2 Warnings and

(http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm? (Prothrombin) Precautions
Avatrombopag (2) Hematology F5 Warnings and

(http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm? (Factor V Leiden) Precautions 
event=overview.process&varApplNo=210238) Top ()
Avatrombopag (3) Hematology PROC Warnings and

Avatrombopag (4) Hematology PROS1 Warnings and

Avatrombopag (5) Hematology SERPINC1 Warnings and

(http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm? (Antithrombin III) Precautions
Avatrombopag (6) Hematology CYP2C9 Clinical Pharmacology

Avelumab Oncology CD274 Clinical Studies

(http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm? (PD-L1)
Azacitidine (1 Oncology CBL Clinical Studies

event=overview.process&varApplNo=050794))
Azacitidine (2) Oncology PTPN11 Clinical Studies

Azacitidine (3) Oncology RAS Clinical Studies

Azathioprine (1) Rheumatology TPMT Dosage and

event=overview.process&varApplNo=016324) Warnings,
Precautions, Drug
Interactions, Adverse
Reactions, Clinical
Pharmacology
Azathioprine (2) Rheumatology NUDT15 Dosage and

event=overview.process&varApplNo=016324) Warnings, Precautions,
Adverse Reactions,
Belinostat Oncology UGT1A1 Dosage and

(http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm? Administration, Clinical
event=overview.process&varApplNo=206256) Pharmacology
Belzutifan (1) Oncology CYP2C19 Warnings and

(http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm? Precautions, Drug
event=overview.process&varApplNo=215383) Interactions, Use in
Belzutifan (2) Oncology UGT2B17 Warnings and

Belzutifan (3) Oncology VHL Clinical Studies

Betaine Inborn Errors of CBS, MMADHC, Indications and Usage,

(http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm? Metabolism MTHFR Warnings and
event=overview.process&varApplNo=020576) (Homocystinuria Precautions, Clinical
Deficiency) Pharmacology, Clinical
Studies

Top ()
Binimetinib (1) Oncology BRAF Indications and Usage,

Warnings and
Reactions, Use in
Clinical Studies
Binimetinib (2) Oncology UGT1A1 Clinical Pharmacology

Blinatumomab (1) Oncology BCR-ABL1 Adverse Reactions,

(http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm? (Philadelphia Clinical Studies
event=overview.process&varApplNo=125557) chromosome)
Blinatumomab (2) Oncology CD19 Indications and Usage

Boceprevir Infectious Diseases IFNL3 Clinical Pharmacology

(http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm? (IL28B)
Bosutinib Oncology BCR-ABL1 Indications and Usage,

event=overview.process&varApplNo=203341) chromosome) Administration,
Warnings and
Reactions, Use in
Clinical Studies
Brentuximab Vedotin (1) Oncology ALK Use in Specific

(http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm? Populations, Clinical
event=overview.process&varApplNo=125388) Studies
Brentuximab Vedotin (2) Oncology TNFRSF8 Indications and Usage,

(http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm? (CD30) Dosage and
Reactions, Use in
Clinical Studies
Brexpiprazole Psychiatry CYP2D6 Dosage and

Brigatinib Oncology ALK Indications and Usage,

Reactions, Clinical
Studies
Brivaracetam Neurology CYP2C19 Clinical Pharmacology

Bupivacaine (1) Anesthesiology G6PD Warnings

Bupivacaine (2) Anesthesiology Nonspecific Warnings

(http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm? (Congenital
Bupropion Psychiatry CYP2D6 Clinical Pharmacology


Top ()
Busulfan Oncology BCR-ABL1 Clinical Studies

(http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm? (Philadelphia
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,

Studies
Capecitabine (1) Oncology DPYD Warnings and

event=overview.process&varApplNo=020896) Pharmacology, Patient
Capecitabine (2) Oncology ERBB2 Indications and Usage,

Reactions, Clinical
Studies
Capivasertib (1) Oncology AKT1 Indications and Usage,

Reactions, Clinical
Studies
Capivasertib (2) Oncology ERBB2 Indications and Usage,

Studies
Capivasertib (3) Oncology ESR Indications and Usage,

Studies
Capivasertib (4) Oncology PIK3CA Indications and Usage,

Reactions, Clinical
Studies
Capivasertib (5) Oncology PTEN Indications and Usage,

Reactions, Clinical
Studies
Carbamazepine (1) Neurology HLA-B Boxed Warning,

(http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm? Warnings, Precautions
Carbamazepine (2) Neurology HLA-A Warnings


Top ()
Carglumic Acid Inborn Errors of NAGS Indications and Usage,

(http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm? Metabolism Dosage and
Warnings and
Precautions, Use in
Clinical Studies
Cariprazine Psychiatry CYP2D6 Clinical Pharmacology

Carisoprodol Rheumatology CYP2C19 Use in Specific

Carvedilol Cardiology CYP2D6 Drug Interactions,

(http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm? Clinical Pharmacology
Casimersen Neurology DMD Indications and Usage,

event=overview.process&varApplNo=213026) Use in Specific
Populations, Clinical
Studies
Ceftriaxone (1) Infectious Diseases G6PD Warnings

Ceftriaxone (2) Infectious Diseases Nonspecific Warnings

Celecoxib Rheumatology CYP2C9 Dosage and

Cemiplimab-rwlc (1) Oncology ALK Indications and Usage,

Cemiplimab-rwlc (2) Oncology CD274 Indications and Usage,

Studies
Cemiplimab-rwlc (3) Oncology EGFR Indications and Usage,

Cemiplimab-rwlc (4) Oncology ROS1 Indications and Usage,

Ceritinib Oncology ALK Indications and Usage,

Warning and
Reactions, Clinical
Studies
Cerliponase Alfa Inborn Errors of TPP1 Indications and Usage,

(http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm? Metabolism Use in Specific
event=overview.process&varApplNo=761052) Populations, Clinical
Studies

Top ()
Cetuximab (1) Oncology EGFR Indications and Usage,

Reactions, Clinical
Studies
Cetuximab (2) Oncology RAS Indications and Usage,

Warnings and
Reactions, Clinical
Studies
Cetuximab (3) Oncology BRAF Indications and Usage,

Reactions, Use in
Clinical Studies
Cevimeline Dental CYP2D6 Precautions

Chloroprocaine (1) Anesthesiology G6PD Warnings

Chloroprocaine (2) Anesthesiology Nonspecific Warnings

Chloroquine Infectious Diseases G6PD Precautions, Adverse

Chlorpropamide Endocrinology G6PD Precautions

Cholic Acid Inborn Errors of AMACR, AKR1D1, Indications and Usage,

(http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm? Metabolism CYP7A1, CYP27A1, Dosage and
event=overview.process&varApplNo=205750) DHCR7, HSD3B2 Administration,
(Bile Acid Synthesis Warnings and
Disorders) Precautions, Adverse
Reactions, Use in
Clinical Studies
Cisplatin Oncology TPMT Adverse Reactions

Citalopram (1) Psychiatry CYP2C19 Dosage and

event=overview.process&varApplNo=020822) Warnings, Clinical
Pharmacology
Citalopram (2) Psychiatry CYP2D6 Clinical Pharmacology

Clobazam Neurology CYP2C19 Dosage and

Clomipramine Psychiatry CYP2D6 Precautions


Top ()
Clopidogrel Cardiology CYP2C19 Boxed Warning,

(http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm? Warnings and
event=overview.process&varApplNo=020839) Precautions, Clinical
Pharmacology
Clozapine Psychiatry CYP2D6 Dosage and

Cobimetinib Oncology BRAF Indications and Usage,

Reactions, Clinical
Studies
Codeine Anesthesiology CYP2D6 Boxed Warning,

event=overview.process&varApplNo=022402) Precautions, Use in
Patient Counseling
Information
Crizanlizumab-tmca Hematology HBB Adverse Reactions,

Crizotinib (1) Oncology ALK Indications and Usage,

Reactions, Use in
Clinical Studies
Crizotinib (2) Oncology ROS1 Indications and Usage,

Reactions, Use in
Clinical Studies
Dabrafenib (1) Oncology BRAF Indications and Usage,

Warnings and
Reactions, Use in
Clinical Studies
Dabrafenib (2) Oncology G6PD Warnings and

(http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm? Precautions, Adverse
event=overview.process&varApplNo=202806) Reactions, Patient
Dabrafenib (3) Oncology RAS Dosage and

Precautions
Daclatasvir Infectious Diseases IFNL3 Clinical Studies

Dacomitinib Oncology EGFR Indications and Usage,

Reactions, Use in
Clinical Studies 
Top ()
Dapsone (1) Dermatology G6PD Warnings and

(http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm? Precautions, Use in
Patient Counseling
Information
Dapsone (2) Dermatology Nonspecific Warnings and

(http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm? (Congenital Precautions, Adverse
event=overview.process&varApplNo=021794) Methemoglobinemia) Reactions, Patient
Dapsone (3) Infectious Diseases G6PD Precautions, Adverse

(http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm? Reactions, Overdosage
Darifenacin Urology CYP2D6 Clinical Pharmacology

Dasabuvir, Ombitasvir, Paritaprevir, and Ritonavir Infectious Diseases IFNL3 Clinical Studies
Dasatinib Oncology BCR-ABL1 Indications and Usage,

Warnings and
Reactions, Use in
Clinical Studies
Denileukin Diftitox Oncology IL2RA Indications and Usage,

(http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm? (CD25 antigen) Clinical Studies
Desipramine Psychiatry CYP2D6 Precautions

Desflurane Anesthesiology CACNA1S, RYR1 Contraindications,

(http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm? (Genetic Susceptibility Warnings and
event=overview.process&varApplNo=020118) to Malignant Precautions, Clinical
Hyperthermia) Pharmacology
Desmopressin Hematology F8 Indications and Usage,

Pharmacology
Desvenlafaxine Psychiatry CYP2D6 Clinical Pharmacology

Deutetrabenazine Neurology CYP2D6 Dosage and

Dexlansoprazole Gastroenterology CYP2C19 Drug Interactions,

Dextromethorphan and Quinidine Neurology CYP2D6 Warnings and

Diazepam Neurology CYP2C19 Clinical Pharmacology

Dinutuximab Oncology MYCN Clinical Studies


Top ()
Docetaxel Oncology ESR, PGR Clinical Studies

(http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm? (Hormone Receptor)
Dolutegravir Infectious Diseases UGT1A1 Clinical Pharmacology

Donepezil Neurology CYP2D6 Clinical Pharmacology

Dostarlimab-gxly Oncology Microsatellite Indications and Usage,

(http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm? Instability, Mismatch Dosage and
event=overview.process&varApplNo=761174) Repair Administration, Adverse
Reactions, Clinical
Studies
Doxepin (1) Psychiatry CYP2D6 Clinical Pharmacology

Doxepin (2) Psychiatry CYP2C19 Clinical Pharmacology

Dronabinol Gastroenterology CYP2C9 Use in Specific

Drospirenone and Ethinyl Estradiol Gynecology CYP2C19 Clinical Pharmacology

Duloxetine Psychiatry CYP2D6 Drug Interactions

Durvalumab (1) Oncology ALK Indications and Usage,

Durvalumab (2) Oncology EGFR Indications and Usage,

Durvalumab (3) Oncology CD274 Clinical Pharmacology,

(http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm? (PD-L1) Clinical Studies
Duvelisib Oncology Chromosome 17p Clinical Studies

Eculizumab (1) Neurology ACHR Indications and Usage,

Eculizumab (2) Neurology AQP4 Indications and Usage,

Efavirenz Infectious Diseases CYP2B6 Clinical Pharmacology

Efgartigimod Alfa-fcab Neurology ACHR Indications and Usage,

(http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm? Clinical Pharmacology,
Eflornithine Oncology MYCN Adverse Reactions,

event=overview.process&varApplNo=215500) 
Top ()
Elacestrant (1) Oncology ESR Indications and Usage,

Reactions, Clinical
Studies
Elacestrant (2) Oncology ERBB2 Indications and Usage,

Reactions, Clinical
Studies
Elagolix Gynecology SLCO1B1 Clinical Pharmacology

Elbasvir and Grazoprevir Infectious Diseases IFNL3 Clinical Studies

Elexacaftor, Ivacaftor, and Tezacaftor Pulmonary CFTR Indications and Usage,

(http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm? Use in Specific
Studies
Eliglustat Inborn Errors of CYP2D6 Indications and Usage,

Contraindications,
Warnings and
Precautions, Drug
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 GALNS Indications and Usage,

(http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm? Metabolism Warnings and
Clinical Studies
Eltrombopag (1) Hematology F5 Warnings and

(http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm? (Factor V Leiden) Precautions
Eltrombopag (2) Hematology SERPINC1 Warnings and

Eltrombopag (3) Hematology Chromosome 7 Adverse Reactions

Eltrombopag (4) Hematology Chromosome 13 Adverse Reactions


Top ()
Emapalumab-lzsg Hematology PRF1, RAB27A, Clinical Studies

(http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm? SH2D1A, STXBP2,
event=overview.process&varApplNo=761107) STX11, UNC13D,
XIAP
(Hemophagocytic
Lymphohistiocytosis)
Enasidenib Oncology IDH2 Indications and Usage,

Studies
Encorafenib (1) Oncology BRAF Indications and Usage,

Warnings and
Reactions, Use in
Clinical
Studies, Patient
Encorafenib (2) Oncology RAS Dosage and

Precautions, Clinical
Studies
Entrectinib (1) Oncology ROS1 Indications and Usage,

Reactions, Use in
Clinical Studies
Entrectinib (2) Oncology NTRK Indications and Usage,

Reactions, Use in
Clinical Studies
Eplontersen Neurology TTR Adverse Reactions,

Erdafitinib (1) Oncology FGFR Indications and Usage,

Reactions, Clinical
Studies, Patient
Erdafitinib (2) Oncology CYP2C9 Use in Specific

Eribulin (1) Oncology ERBB2 Clinical Studies

(http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm? (HER2)
Eribulin (2) Oncology ESR, PGR Clinical Studies


Top ()
Erlotinib Oncology EGFR Indications and Usage,

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,

Estradiol and Progesterone (1) Gynecology PROC Contraindications

Estradiol and Progesterone (2) Gynecology PROS1 Contraindications

Estradiol and Progesterone (3) Gynecology SERPINC1 Contraindications

(http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm? (Antithrombin III)
Estradiol Valerate Gynecology ESR, PGR Warnings

Eteplirsen Neurology DMD Indications and Usage,

Studies
Etrasimod Gastroenterology CYP2C9 Drug Interactions, Use

(http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm? in Specific Populations,
event=overview.process&varApplNo=216956) Clinical Pharmacology
Everolimus (1) Oncology ERBB2 Indications and Usage,

Warnings and
Reactions, Use in
Clinical Studies
Everolimus (2) Oncology ESR Indications and Usage,

Warnings and
Reactions, Use in
Clinical Studies
Evinacumab-dgnb (1) Endocrinology LDLR Clinical Studies


Top ()
Evinacumab-dgnb (2) Endocrinology Nonspecific Indication and Usage,

(http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm? (Homozygous Familial Adverse Reactions,
event=overview.process&varApplNo=761181) Hypercholesterolemia) Use in Specific
Studies
Evolocumab (1) Endocrinology Nonspecific Indications and Usage,

(http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm? (Heterozygous Dosage and
event=overview.process&varApplNo=125522) Familial Administration, Adverse
Hypercholesterolemia) Reactions, Use in
Clinical Studies
Evolocumab (2) Endocrinology Nonspecific Indications and Usage,

(http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm? (Homozygous Familial Dosage and
event=overview.process&varApplNo=125522) Hypercholesterolemia) Administration, Adverse
Reactions, Use in
Clinical Studies
Exemestane Oncology ESR, PGR Indications and Usage,

Studies
Fam-Trastuzumab Deruxtecan-nxki (1) Oncology ERBB2 Indications and Usage,

Warnings and
Reactions, Use in
Clinical Studies
Fam-Trastuzumab Deruxtecan-nxki (2) Oncology ESR Clinical Studies

Fesoterodine Urology CYP2D6 Drug Interactions,

Fosphenytoin (1) Neurology CYP2C9 Warnings and

(http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm? Precautions, Use in
Fosphenytoin (2) Neurology HLA-B Warnings and

Flibanserin (1) Gynecology CYP2C9 Clinical Pharmacology

Flibanserin (2) Gynecology CYP2C19 Adverse Reactions,

Pharmacology
Flibanserin (3) Gynecology CYP2D6 Clinical Pharmacology

Fluorouracil (1) Dermatology DPYD Contraindications,

(http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm? Warnings
Top ()
Fluorouracil (2) Oncology DPYD Warnings and

(http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm? Precautions, Patient
event=overview.process&varApplNo=012209) Counseling Information
Fluoxetine Psychiatry CYP2D6 Warnings and

event=overview.process&varApplNo=018936) 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,

Reactions, Use in
Clinical Studies
Fruquintinib Oncology RAS Indications and Usage,

Fulvestrant (1) Oncology ERBB2 Indications and Usage,

(http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm? (HER2) Adverse Reactions,
Fulvestrant (2) Oncology ESR, PGR Indications and Usage,

event=overview.process&varApplNo=021344) Clinical Pharmacology,
Clinical Studies
Futibatinib Oncology FGFR2 Indications and Usage,

Reactions, Clinical
Studies
Galantamine Neurology CYP2D6 Clinical Pharmacology

Ganaxolone Neurology CDKL5 Indications and Usage,

Gefitinib (1) Oncology EGFR Indications and Usage,

Studies
Gefitinib (2) Oncology CYP2D6 Clinical Pharmacology


Top ()
Gemtuzumab Ozogamicin Onoclogy CD33 Indications and Usage,

Reactions, Clinical
Studies
Gentamicin Infectious Diseases MT-RNR1 Warnings

Gilteritinib Oncology FLT3 Indications and Usage,

Studies
Givosiran Gastroenterology CPOX, HMBS, PPOX Clinical Studies

(http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm? (Acute Hepatic
event=overview.process&varApplNo=212194) Porphyria)
Glimepiride Endocrinology G6PD Warnings and

event=overview.process&varApplNo=020496) Reactions
Glipizide Endocrinology G6PD Precautions

Glyburide Endocrinology G6PD Precautions

Glycerol Phenylbutyrate (1) Inborn Errors of ASS1, CPS1, OTC Indications and Usage,
(http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm? Metabolism (Urea Cycle Adverse Reactions,
event=overview.process&varApplNo=203284) Disorders) Clinical Studies
Glycerol Phenylbutyrate (2) Inborn Errors of NAGS Indications and Usage

(http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm? Metabolism
Golodirsen Neurology DMD Indications and Usage,

Studies
Goserelin Oncology ESR, PGR Indications and Usage,

(http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm? (Hormone Receptor) Clinical Studies
Hydralazine Cardiology Nonspecific Clinical Pharmacology

(http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm? (NAT)
Hydroxychloroquine Infectious Diseases G6PD Warnings and

Ibrutinib (1) Oncology Chromosome 17p Indications and Usage,

Ibrutinib (2) Oncology Chromosome 11q Clinical Studies

Ibrutinib (3) Oncology MYD88 Clinical Studies


Top ()
Iloperidone Psychiatry CYP2D6 Dosage and

Precautions, Drug
Interactions, Clinical
Pharmacology
Imatinib (1) Oncology KIT Indications and Usage,

Studies
Imatinib (2) Oncology BCR-ABL1 Indications and Usage,

Warnings and
Reactions, Use in
Clinical Studies
Imatinib (3) Oncology PDGFRB Indications and Usage,

Studies
Imatinib (4) Oncology FIP1L1-PDGFRA Indications and Usage,

Studies
Imipramine Psychiatry CYP2D6 Precautions

Inclisiran Endocrinology Nonspecific Indications and Usage,

(http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm? (Heterozygous Clinical Studies
event=overview.process&varApplNo=214012) Familial
Hypercholesterolemia)
Indacaterol Pulmonary UGT1A1 Clinical Pharmacology

Inebilizumab-cdon Neurology AQP4 Indications and Usage,

Infigratinib Oncology FGFR2 Indications and Usage,

Studies
Inotersen Neurology TTR Adverse Reactions,

Inotuzumab Ozogamicin Oncology BCR-ABL1 Clinical Studies

Ipilimumab (1) Oncology HLA-A Clinical Studies

Ipilimumab (2) Oncology Microsatellite Indications and Usage,

event=overview.process&varApplNo=125377) Repair Administration,
Warnings and
Reactions, Use in 
Top ()
Clinical Studies
Ipilimumab (3) Oncology CD274 Indications and Usage,

event=overview.process&varApplNo=125377) Administration, Use in
Clinical Studies
Ipilimumab (4) Oncology ALK Indications and Usage,

Ipilimumab (5) Oncology EGFR Indications and Usage,

Irinotecan Oncology UGT1A1 Dosage and

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 Contraindications,

(http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm? (Genetic Susceptibility Warnings, Clinical
event=overview.process&varApplNo=017624) to Malignant Pharmacology
Hyperthermia)
Isoniazid, Pyrazinamide, and Rifampin Infectious Diseases Nonspecific Clinical Pharmacology

Isosorbide Dinitrate Cardiology CYB5R Overdosage

Isosorbide Mononitrate Cardiology CYB5R Overdosage

Ivacaftor Pulmonary CFTR Indications and Usage,

Studies
Ivacaftor and Lumacaftor Pulmonary CFTR Indications and Usage,

Studies
Ivacaftor and Tezacaftor Pulmonary CFTR Indications and Usage,

Studies
Ivosidenib Oncology IDH1 Indications and Usage,


Top ()
Studies
Ixabepilone (1) Oncology ERBB2 Clinical Studies

(http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm? (HER2)
Ixabepilone (2) Oncology ESR, PGR Clinical Studies

Lacosamide Neurology CYP2C19 Clinical Pharmacology

Lansoprazole Gastroenterology CYP2C19 Drug Interactions,

Lapatinib (1) Oncology ERBB2 Indications and Usage,

Reactions, Use in
Clinical Studies
Lapatinib (2) Oncology ESR, PGR Indications and Usage,

Reactions, Use in
Clinical Studies
Lapatinib (3) Oncology HLA-DQA1 Clinical Pharmacology

Lapatinib (4) Oncology HLA-DRB1 Clinical Pharmacology

Larotrectinib Oncology NTRK Indications and Usage,

Reactions, Clinical
Studies
Lecanemab-irmb Neurology APOE Boxed Warning,

event=overview.process&varApplNo=761269) Precautions, Clinical
Studies, Patient
Ledipasvir and Sofosbuvir Infectious Diseases IFNL3 Clinical Studies

Lenalidomide Hematology Chromosome 5q Boxed Warning,

(http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm? Indications and Usage,
event=overview.process&varApplNo=021880) Adverse Reactions,
Use in Specific
Studies
Leniolisib (1) Pulmonary PIK3CD Clinical Studies

Leniolisib (2) Pulmonary PIK3R1 Clinical Studies

Lenvatinib Oncology Microsatellite Indications and Usage,

(http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm? Instability, Mismatch Adverse Reactions,
event=overview.process&varApplNo=206947) Repair Clinical Studies

Top ()
Lesinurad Rheumatology CYP2C9 Drug Interactions,

Letrozole Oncology ESR, PGR Indications and Usage,

Levothyroxine Endocrinology Nonspecific Indications and Usage,

(http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm? (Congenital Warnings and
event=overview.process&varApplNo=021402) Hypothyroidism) Precautions, Use in
Specific Populations
Lidocaine and Prilocaine (1) Anesthesiology Nonspecific Warnings and

Lidocaine and Prilocaine (2) Anesthesiology G6PD Warnings and

Lidocaine and Tetracaine (1) Anesthesiology G6PD Warnings and

Lidocaine and Tetracaine (2) Anesthesiology Nonspecific Warnings and

Lofexidine Anesthesiology CYP2D6 Use in Specific

(http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm? Populations
Lomitapide Endocrinology Nonspecific Indications and Usage,

(http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm? (Homozygous Familial Warnings and
event=overview.process&varApplNo=203858) Hypercholesterolemia) Precautions, Adverse
Reactions, Clinical
Studies
Lonafarnib (1) Inborn Errors of LMNA Indications and Usage,

(http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm? Metabolism Adverse Reactions,
Studies
Lonafarnib (2) Inborn Errors of ZMPSTE24 Indications and Usage,

(http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm? Metabolism Use in Specific
event=overview.process&varApplNo=213969) Populations
Lorlatinib (1) Oncology ALK Indications and Usage,

Reactions, Clinical
Studies
Lorlatinib (2) Oncology ROS1 Adverse Reactions

Lumasiran Urology AGXT Indications and Usage,

Studies
Luspatercept–aamt Hematology HBB Clinical Studies

Lusutrombopag (1) Hematology F2 Warnings and


Top ()
Lusutrombopag (2) Hematology F5 Warnings and

Lusutrombopag (3) Hematology PROC Warnings and

Lusutrombopag (4) Hematology PROS1 Warnings and

Lusutrombopag (5) Hematology SERPINC1 Warnings and

Lutetium Lu 177 Dotatate Oncology SSTR Indications and Usage,

Clinical Studies
Lutetium Lu 177 Vipivotide Tetraxetan Oncology FOLH1 Indications and Usage,

(http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm? (PSMA) Dosage and
Reactions, Clinical
Studies
Mafenide Infectious Diseases G6PD Warnings, Adverse

Maralixibat Gastroenterology JAG1 Clinical Studies

Margetuximab-cmkb (1) Oncology ERBB2 Indications and Usage,

Clinical Studies
Margetuximab-cmkb (2) Oncology FCGR2A Clinical Pharmacology

(http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm? (CD32A)
Margetuximab-cmkb (3) Oncology FCGR2B Clinical Pharmacology

(http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm? (CD32B)
Margetuximab-cmkb (4) Oncology FCGR3A Clinical Pharmacology

(http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm? (CD16A)
Mavacamten Cardiology CYP2C19 Dosage and

Meclizine Neurology CYP2D6 Warnings and

Meloxicam Anesthesiology CYP2C9 Use in Specific

Mepivacaine (1) Anesthesiology G6PD Warnings

Mepivacaine (2) Anesthesiology Nonspecific Warnings


Top ()
Mepolizumab Oncology FIP1L1-PDGFRA Adverse Reactions,

Mercaptopurine (1) Oncology TPMT Dosage and

Reactions, Clinical
Pharmacology
Mercaptopurine (2) Oncology NUDT15 Dosage and

Pharmacology
Methylene Blue Hematology G6PD Contraindications,

event=overview.process&varApplNo=204630) Precautions
Metoclopramide (1) Gastroenterology CYB5R Use in Specific

(http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm? Populations
Metoclopramide (2) Gastroenterology G6PD Use in Specific

(http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm? Populations,
event=overview.process&varApplNo=017854) Overdosage
Metoclopramide (3) Gastroenterology CYP2D6 Dosage and

Metoprolol Cardiology CYP2D6 Clinical Pharmacology

Metreleptin Endocrinology LEP Contraindications

Midostaurin (1) Oncology FLT3 Indications and Usage,

Reactions, Clinical
Studies
Midostaurin (2) Oncology NPM1 Clinical Studies

Midostaurin (3) Oncology KIT Clinical Studies

Migalastat Inborn Errors of GLA Indications and Usage,

Studies
Mirabegron Urology CYP2D6 Clinical Pharmacology

Mirvetuximab Soravtansine-gynx Oncology FOLR1 Indications and Usage,

Studies
Mitapivat Hematology PKLR Clinical Studies


Top ()
Mivacurium Anesthesiology BCHE Warnings, Precautions,

Mobocertinib Oncology EGFR Indications and Usage,

Reactions, Clinical
Studies
Modafinil Psychiatry CYP2D6 Clinical Pharmacology

Mycophenolic Acid Transplantation HPRT1 Warnings and

Nalidixic Acid Infectious Diseases G6PD Precautions, Adverse

Nateglinide Endocrinology CYP2C9 Drug Interactions

Nebivolol Cardiology CYP2D6 Dosage and

Nedosiran Nephrology AGXT Indications and Usage,

Studies
Nefazodone Psychiatry CYP2D6 Precautions

Neomycin Infectious Diseases MT-RNR1 Warnings

Neratinib (1) Oncology ERBB2 Indications and Usage,

Neratinib (2) Oncology ESR, PGR Clinical Studies

Nilotinib (1) Oncology BCR-ABL1 Indications and Usage,

Warnings and
Reactions, Use in
Clinical Studies
Nilotinib (2) Oncology UGT1A1 Clinical Pharmacology

Niraparib Oncology BRCA (Homologous Indications and Usage,

(http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm? Recombination Dosage and
event=overview.process&varApplNo=208447) Deficiency) Administration, Clinical
Studies

Top ()
Nitrofurantoin Infectious Diseases G6PD Warnings, Adverse

Nirogacestat (1) Oncology APC Clinical Studies

Nirogacestat (2) Oncology CTNNB1 Clinical Studies

Nivolumab (1) Oncology BRAF Adverse Reactions,

Nivolumab (2) Oncology CD274 Indications and Usage,

event=overview.process&varApplNo=125554) Administration, Use in
Clinical Studies
Nivolumab (3) Oncology Microsatellite Indications and

(http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm? Instability, Mismatch Usage, Clinical Studies
event=overview.process&varApplNo=125554) Repair
Nivolumab (4) Oncology EGFR Indications and Usage,

Nivolumab (5) Oncology ALK Indications and Usage,

Nivolumab (6) Oncology ERBB2 Adverse Reactions,

(http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm? (HER2) Clinical Studies
Nivolumab and Relatlimab-rmbw (1) Oncology BRAF Clinical Studies

Nivolumab and Relatlimab-rmbw (2) Oncology CD274 Clinical Studies

Nivolumab and Relatlimab-rmbw (3) Oncology LAG3 Clinical Studies

Nortriptyline Psychiatry CYP2D6 Precautions

Nusinersen Neurology SMN2 Clinical Pharmacology,

Obinutuzumab Oncology MS4A1 Clinical Studies

(http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm? (CD20 antigen)
Odevixibat (1) Gastroenterology ABCB11 Indications and Usage,

Odevixibat (2) Gastroenterology ATP8B1 Indications and Usage,


Top ()
Odevixibat (3) Gastroenterology JAG1 Clinical Studies

Odevixibat (4) Gastroenterology NOTCH2 Clinical Studies

Olaparib (1) Oncology BRCA Indications and Usage,

Warnings and
Reactions, Clinical
Studies
Olaparib (2) Oncology ERBB2 Indications and Usage,

Reactions, Clinical
Studies
Olaparib (3) Oncology ESR, PGR Indications and Usage,

Olaparib (4) Oncology BRCA, Genomic Indications and Usage,

(http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm? Instability Dosage and
event=overview.process&varApplNo=208558) (Homologous Administration, Adverse
Recombination Reactions, Clinical
Deficiency) Studies
Olaparib (5) Oncology Homologous Indications and Usage,

(http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm? Recombination Repair Dosage and
Reactions, Clinical
Studies
Olaparib (6) Oncology PPP2R2A Clinical Studies

Olaratumab Oncology PDGFRA Clinical Studies

Oliceridine Anesthesiology CYP2D6 Warnings and

Olutasidenib Oncology IDH1 Indications and Usage,

Reactions, Use in
Clinical Studies
Omacetaxine Oncology BCR-ABL1 Clinical Studies

Ombitasvir, Paritaprevir, and Ritonavir Infectious Diseases IFNL3 Clinical Studies

Omeprazole Gastroenterology CYP2C19 Drug Interactions,


Top ()
Oxymetazoline and Tetracaine (1) Anesthesiology G6PD Warnings and

Oxymetazoline and Tetracaine (2) Anesthesiology Nonspecific Warnings and

Ondansetron Gastroenterology CYP2D6 Clinical Pharmacology

Osimertinib Oncology EGFR Indications and Usage,

Reactions, Clinical
Studies
Ospemifene (1) Gynecology CYP2C9 Clinical Pharmacology

Ospemifene (2) Gynecology CYP2B6 Clinical Pharmacology

Oxcarbazepine Neurology HLA-B Warnings and

Palbociclib (1) Oncology ESR Indications and Usage,

Palbociclib (2) Oncology ERBB2 Indications and Usage,

Paliperidone Psychiatry CYP2D6 Clinical Pharmacology

Palonosetron Gastroenterology CYP2D6 Clinical Pharmacology

Panitumumab (1) Oncology EGFR Adverse Reactions,

Panitumumab (2) Oncology RAS Indications and Usage,

Warnings and
Reactions, Clinical
Studies
Pantoprazole Gastroenterology CYP2C19 Clinical Pharmacology

Parathyroid Hormone Inborn Errors of CASR Indications and Usage,

(http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm? Metabolism Clinical Studies
Paroxetine Psychiatry CYP2D6 Drug Interactions,

Patisiran Neurology TTR Adverse Reactions,

event=overview.process&varApplNo=210922) Clinical Studies 
Top ()
Pazopanib (1) Oncology UGT1A1 Clinical Pharmacology

Pazopanib (2) Oncology HLA-B Clinical Pharmacology

Peginterferon Alfa-2b Infectious Diseases IFNL3 Clinical Pharmacology

Pegloticase Rheumatology G6PD Boxed Warning,

(http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm? Contraindications,
Reactions, Patient
Pembrolizumab (1) Oncology BRAF Adverse Reactions,

Pembrolizumab (2) Oncology CD274 Indications and Usage,

Reactions, Use in
Clinical Studies
Pembrolizumab (3) Oncology Microsatellite Indications and Usage,

Reactions, Use in
Clinical Studies
Pembrolizumab (4) Oncology EGFR Indications and Usage,

Pembrolizumab (5) Oncology ALK Indications and Usage,

Pembrolizumab (6) Oncology Tumor Mutational Indications and Usage,

(http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm? Burden Dosage and
Studies
Pembrolizumab (7) Oncology ERBB2 Indications and Usage,

Pemetrexed (1) Oncology ALK Indications and Usage,

Pemetrexed (2) Oncology EGFR Indications and Usage,

Pemetrexed (3) Oncology CD274 Clinical Studies

Pemigatinib (1) Oncology FGFR1 Indications and Usage,

Reactions, Use in
Clinical Studies

Top ()
Pemigatinib (2) Oncology FGFR2 Indications and Usage,

Studies
Perphenazine Psychiatry CYP2D6 Precautions, Clinical

(http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm? Pharmacology
Pertuzumab (1) Oncology ERBB2 Indications and Usage,

Warnings and
Reactions, Clinical
Studies
Pertuzumab (2) Oncology ESR, PGR Clinical Studies

Phenytoin (1) Neurology CYP2C9 Warnings and

(https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm? Precautions, Use in
Phenytoin (2) Neurology CYP2C19 Clinical Pharmacology

(https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
Phenytoin (3) Neurology HLA-B Warnings and

(https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm? Precautions
Pimozide Psychiatry CYP2D6 Dosage and

event=overview.process&varApplNo=017473) 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

Plazomicin Infectious Diseases MT-RNR1 Warnings and


Top ()
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 Indications and Usage,

(http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm? (Philadelphia Warnings and
event=overview.process&varApplNo=203469) chromosome) Precautions, Adverse
Reactions, Use in
Clinical Studies
Pralsetinib Oncology CCDC6-RET, KIF5B- Indications and Usage,

(http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm? RET, RET Dosage and
Reactions, Use in
Clinical Studies
Prasugrel (1) Cardiology CYP2C19 Use in Specific

event=overview.process&varApplNo=022307) Pharmacology, Clinical
Studies
Prasugrel (2) Cardiology CYP2C9 Use in Specific

Studies
Prasugrel (3) Cardiology CYP3A5 Use in Specific

Studies
Prasugrel (4) Cardiology CYP2B6 Use in Specific

Studies
Primaquine (1) Infectious Diseases G6PD Contraindications,

(http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm? Warnings, Precautions,
event=overview.process&varApplNo=008316) Adverse Reactions,
Overdosage
Primaquine (2) Infectious Diseases CYB5R Precautions, Adverse

Probenecid Rheumatology G6PD Adverse Reactions

event=BasicSearch.process)
Procainamide Cardiology Nonspecific Adverse Reactions,

(https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm? (NAT) Clinical Pharmacology
Propafenone Cardiology CYP2D6 Dosage and

Precautions, Drug
Interactions, Clinical
Pharmacology
Propranolol Cardiology CYP2D6 Clinical Pharmacology


Top ()
Protriptyline Psychiatry CYP2D6 Precautions

Quinidine Cardiology CYP2D6 Precautions

Quinine Sulfate (1) Infectious Diseases G6PD Warnings and

Quinine Sulfate (2) Infectious Diseases CYP2D6 Drug Interactions

Quizartinib Oncology FLT3 Indications and Usage,

Warnings and
Reactions, Clinical
Studies
Rabeprazole Gastroenterology CYP2C19 Drug Interactions,

Raloxifene Oncology ESR Clinical Studies

Raltegravir Infectious Diseases UGT1A1 Clinical Pharmacology

Ramucirumab (1) Oncology EGFR Indications and Usage,

Reactions, Clinical
Studies
Ramucirumab (2) Oncology RAS Clinical Studies

Rasburicase (1) Oncology G6PD Boxed Warning,

Precautions
Rasburicase (2) Oncology CYB5R Boxed Warning,

Precautions
Ravulizumab-cwvz Neurology ACHR Indications and Usage,

Regorafenib Oncology RAS Indications and Usage,

Repotrectinib Oncology ROS1 Indications and Usage,

Reactions, Use in
Clinical Studies
Ribociclib (1) Oncology ESR, PGR (Hormone Indications and Usage,


(http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm? Receptor) Adverse Reactions,
Top ()
Ribociclib (2) Oncology ERBB2 Indications and Usage,

Rimegepant Neurology CYP2C9 Clinical Pharmacology

Risdiplam Neurology SMN1, SMN2 Clinical Studies

Risperidone Psychiatry CYP2D6 Clinical Pharmacology

Rituximab Oncology MS4A1 Indications and Usage,

(http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm? (CD20 antigen) Dosage and
Reactions, Use in
Clinical Studies
Rivaroxaban Cardiology F5 Clinical Studies

(http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm? (Factor V Leiden)
Ropeginterferon Alfa-2b-njft Hematology JAK2 Clinical Pharmacology,

Ropivacaine (1) Anesthesiology G6PD Warnings

Ropivacaine (2) Anesthesiology Nonspecific Warnings

Rosuvastatin Endocrinology SLCO1B1 Clinical Pharmacology

Rozanolixizumab-noli (1) Neurology ACHR Indications and Usage,

Rozanolixizumab-noli (2) Neurology MUSK Indications and Usage,

Rucaparib (1) Oncology BRCA Indications and Usage,

Reactions, Clinical
Studies
Rucaparib (2) Oncology CYP2D6 Clinical Pharmacology

Rucaparib (3) Oncology CYP1A2 Clinical Pharmacology

Rucaparib (4) Oncology BRCA, Loss of Warnings and

(http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm? Heterozygosity Precautions, Adverse
event=overview.process&varApplNo=209115) (Homologous Reactions, Clinical
Recombination Studies
Deficiency)
Sacituzumab Govitecan-hziy (1) Oncology UGT1A1 Warnings and

(http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm? Precautions, Clinical
event=overview.process&varApplNo=761115) Pharmacology Top ()
Sacituzumab Govitecan-hziy (2) Oncology BRCA Clinical Studies

Sacituzumab Govitecan-hziy (3) Oncology ESR Indications and Usage,

Studies
Sacituzumab Govitecan-hziy (4) Oncology ERBB2 Indications and Usage,

Studies
Sacrosidase Inborn Errors of Nonspecific Indications and Usage,

(http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm? Metabolism (Congenital Sucrase- Adverse Reactions,
event=overview.process&varApplNo=020772) Isomaltase Clinical Pharmacology
Deficiency)
Satralizumab-mwge Neurology AQP4 Indications and Usage,

Selpercatinib Oncology RET Indications and Usage,

Reactions, Use in
Clinical Studies
Setmelanotide (1) Endocrinology LEPR Indications and Usage,

Reactions, Use in
Clinical Studies
Setmelanotide (2) Endocrinology PCSK1 Indications and Usage,

Reactions, Use in
Clinical Studies
Setmelanotide (3) Endocrinology POMC Indications and Usage,

Reactions, Use in
Clinical Studies
Sevoflurane Anesthesiology CACNA1S, RYR1 Contraindications,

(http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm? (Genetic Susceptibility Warnings, Clinical
event=overview.process&varApplNo=020478) to Malignant Pharmacology
Hyperthermia)
Simeprevir Infectious Diseases IFNL3 Clinical Pharmacology,

(http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm? (IL28B) Clinical Studies
Siponimod Neurology CYP2C9 Dosage and

event=overview.process&varApplNo=209884) Contraindications, Drug
Sodium Nitrite (1) Toxicology G6PD Warnings and

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Sodium Nitrite (2) Toxicology Nonspecific Boxed Warning,

(http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm? (Congenital Warnings and
event=overview.process&varApplNo=203922) Methemoglobinemia) Precautions
Sodium Oxybate Neurology ALDH5A1 Contraindications

(http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm? (Succinic
event=overview.process&varApplNo=021196) Semialdehyde
Dehydrogenase
Deficiency)
Sodium Phenylbutyrate Inborn Errors of ASS1, CPS1, OTC Indications and Usage,
(http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm? Metabolism (Urea Cycle Dosage and
event=overview.process&varApplNo=020572) Disorders) Administration, Adverse
Reactions, Clinical
Pharmacology
Sofosbuvir Infectious Diseases IFNL3 Clinical Studies

Sofosbuvir and Velpatasvir Infectious Diseases IFNL3 Clinical Studies

Sofosbuvir, Velpatasvir, and Voxilaprevir Infectious Diseases IFNL3 Clinical Studies

Sotorasib Oncology KRAS Indication and Usage,

Reactions, Clinical
Studies
Streptomycin Infectious Diseases MT-RNR1 Warnings

Succimer Hematology G6PD Clinical Pharmacology

Succinylcholine (1) Anesthesiology BCHE Warnings, Precautions

Succinylcholine (2) Anesthesiology CACNA1S, RYR1 Boxed Warning,

(http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm? (Genetic Susceptibility Contraindications,
to Malignant
event=overview.process&varApplNo=008453) Hyperthermia) Warnings, Precautions,
Adverse Reactions,
Sulfadiazine Infectious Diseases G6PD Warnings

Sulfamethoxazole and Trimethoprim (1) Infectious Diseases G6PD Precautions

Sulfamethoxazole and Trimethoprim (2) Infectious Diseases Nonspecific Precautions

Sulfasalazine (1) Gastroenterology G6PD Precautions

Sulfasalazine (2) Gastroenterology Nonspecific Clinical Pharmacology


Top ()
Synthetic Conjugated Estrogens, A (1) Gynecology PROC Contraindications

Synthetic Conjugated Estrogens, A (2) Gynecology PROS1 Contraindications

Synthetic Conjugated Estrogens, A (3) Gynecology SERPINC1 Contraindications

(http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm? (Antithrombin III)
Tafamidis Cardiology TTR Clinical Pharmacology,

Tafenoquine Infectious Diseases G6PD Dosage and

event=overview.process&varApplNo=210607) Contraindications,
Warnings and
Precautions, Use in
Patient Counseling
Information
Talazoparib (1) Oncology BRCA Indications and Usage,

Reactions, Clinical
Studies
Talazoparib (2) Oncology ERBB2 Indications and Usage,

Talazoparib (3) Oncology Homologous Indications and Usage,

(http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm? Recombination Dosage and
event=overview.process&varApplNo=211651) Repair Administrations,
Adverse Reactions,
Drug Interactions,
Clinical Studies
Tamoxifen (1) Oncology ESR, PGR Indications and Usage,

Clinical Studies
Tamoxifen (2) Oncology F5 Warnings and

Tamoxifen (3) Oncology F2 Warnings and

Tamoxifen (4) Oncology CYP2D6 Clinical Pharmacology

Tamsulosin Urology CYP2D6 Warnings and

Pharmacology
Tebentafusp-tebn Oncology HLA-A Indications and Usage,

Studies
Teclistamab-cqyv (1) Oncology Chromosome 17p Clinical Studies

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Teclistamab-cqyv (2) Oncology Chromosome 4p;14q Clinical Studies

Teclistamab-cqyv (3) Oncology Chromosome 14q;16q Clinical Studies

Telaprevir Infectious Diseases IFNL3 Clinical Pharmacology,

(http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm? (IL28B) Clinical Studies
Tepotinib (1) Oncology ALK Clinical Studies

Tepotinib (2) Oncology EGFR Clinical Studies

Tepotinib (3) Oncology MET Indications and Usage,

Reactions, Use in
Clinical Studies
Tetrabenazine Neurology CYP2D6 Dosage and

Precautions, Use in
Thioguanine (1) Oncology TPMT Dosage and

Thioguanine (2) Oncology NUDT15 Dosage and

Thioridazine Psychiatry CYP2D6 Contraindications,

(http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm? Warnings, Precautions
Ticagrelor Cardiology CYP2C19 Clinical Pharmacology

Tipiracil and Trifluridine (1) Oncology ERBB2 Indications and Usage,

Tipiracil and Trifluridine (2) Oncology RAS Indications and Usage,

Tobramycin Infectious Diseases MT-RNR1 Warnings and

Tofersen Oncology SOD1 Indications and Usage,

Studies
Tolazamide Endocrinology G6PD Precautions

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Tolbutamide Endocrinology G6PD Precautions

Tolterodine Urology CYP2D6 Warnings and

Pharmacology
Toremifene Oncology ESR Indications and Usage,

Tramadol Anesthesiology CYP2D6 Boxed Warning,

Patient Counseling
Information
Trametinib (1) Oncology BRAF Indications and Usage,

Reactions, Use in
Clinical Studies
Trametinib (2) Oncology G6PD Adverse Reactions

Trametinib (3) Oncology RAS Warnings and

Trastuzumab (1) Oncology ERBB2 Indications and Usage,

Studies
Trastuzumab (2) Oncology ESR, PGR Clinical Studies

Tretinoin Oncology PML-RARA Indications and Usage,

Warnings and
Precautions, Patient
Triheptanoin Inborn Errors of ACADVL, CPT2, Indications and Usage,

(http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm? Metabolism HADHA, HADHB Clinical Studies
event=overview.process&varApplNo=213687) (Long-Chain Fatty
Acid Oxidation
Disorders)
Tremelimumab-actl (1) Oncology ALK Indications and Usage,

Tremelimumab-actl (2) Oncology EGFR Indications and Usage,

Tremelimumab-actl (3) Oncology CD274 Clinical Studies

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Trimipramine Psychiatry CYP2D6 Precautions

Trofinetide Neurology MECP2 Clinical Studies

Tucatinib (1) Oncology ERBB2 Indications and Usage,

Reactions, Clinical
Studies
Tucatinib (2) Oncology Microsatellite Indications and Usage,

Reactions, Clinical
Studies
Tucatinib (3) Oncology RAS Clinical Studies

Umeclidinium Pulmonary CYP2D6 Clinical Pharmacology

Upadacitinib Rheumatology CYP2D6 Clinical Pharmacology

Ustekinumab Dermatology and IL12A, IL12B, IL23A Warnings and

(http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm? Gastroenterology Precautions
Valbenazine Neurology CYP2D6 Dosage and

Precautions, Use in
Valproic Acid (1) Neurology POLG Boxed Warning,

Precautions
Valproic Acid (2) Neurology Nonspecific Contraindications,

(http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm? (Urea Cycle Warnings and
event=overview.process&varApplNo=018081) Disorders) Precautions
Vemurafenib (1) Oncology BRAF Indications and Usage,

Warnings and
Reactions, Use in
Clinical Studies, Patient
Vemurafenib (2) Oncology RAS Warnings and

Venetoclax (1) Oncology Chromosome 17p Clinical Studies

Venetoclax (2) Oncology Chromosome 11q Clinical Studies

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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

(http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm? in Specific Populations,
event=overview.process&varApplNo=020699) Clinical Pharmacology
Viloxazine (1) Psychiatry CYP2D6 Clinical Pharmacology

Viloxazine (2) Psychiatry SLCO1B1 Clinical Pharmacology

Viltolarsen Neurology DMD Indications and Usage,

Studies
Vincristine Oncology BCR-ABL1 Indications and Usage,

(http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm? (Philadelphia Adverse Reactions,
event=overview.process&varApplNo=202497) chromosome) Clinical Studies
Voriconazole Infectious Diseases CYP2C19 Clinical Pharmacology

Vortioxetine Psychiatry CYP2D6 Dosage and

Voxelotor Hematology HBB Clinical Pharmacology,

Vutrisiran Neurology TTR Adverse Reactions,

Warfarin (1) Hematology CYP2C9 Dosage and

(http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm? Administration, Drug
Pharmacology
Warfarin (2) Hematology VKORC1 Dosage and


Top ()
Warfarin (3) Hematology PROS1 Warnings and

Warfarin (4) Hematology PROC Warnings and

Zanubrutinib (1) Oncology MYD88 Adverse Reactions,

Zanubrutinib (2) Oncology Chromosome 17p Adverse Reactions,

Zanubrutinib (3) Oncology TP53 Clinical Studies

Zilucoplan Neurology ACHR Indications and Usage,

Showing 1 to 593 of 593 entries

* 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 (/media/124784/download?attachment).
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FARMACO-Table of Pharmacogenomic Biomarkers in Drug Labeling - FDA

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FARMACO-Table of Pharmacogenomic Biomarkers in Drug Labeling - FDA

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23/02/2024, 20:28 Table of Pharmacogenomic Biomarkers in Drug Labeling | FDA

Table of Pharmacogenomic Biomarkers in Drug Labeling

Drug exposure and clinical response variability

Mechanisms of drug action

Trial design features

Pharmacogenomic Biomarkers in Drug Labeling

 Drug  Therapeutic Area*  Biomarker†  Labeling Sections 

Abacavir Infectious Diseases HLA-B Boxed Warning,

Abemaciclib (1) Oncology ESR Indications and Usage,

Abemaciclib (2) Oncology ERBB2 Indications and Usage,

 Drug  Therapeutic Area*  Biomarker†  Labeling Sections 

Abemaciclib (3) Oncology MKI67 Clinical Studies

Abrocitinib Dermatology CYP2C19 Dosage and

Adagrasib Oncology KRAS Indications and Usage,

Ado-Trastuzumab Emtansine Oncology ERBB2 Indications and Usage,

Aducanumab-avwa Neurology APOE Warnings and

Afatinib Oncology EGFR Indications and Usage,

Alectinib Oncology ALK Indications and Usage,

Alglucosidase Alfa Inborn Errors of GAA Warnings and

Allopurinol Oncology HLA-B Warnings

Alpelisib (1) Oncology ERBB2 Indication and Usage,

Alpelisib (2) Oncology ESR Indication and Usage,

Alpelisib (3) Oncology PIK3CA Indication and Usage,

Amifampridine Neurology NAT2 Dosage and

 Drug  Therapeutic Area*  Biomarker†  Labeling Sections 

Amifampridine Phosphate Neurology NAT2 Dosage and

Amikacin Infectious Diseases MT-RNR1 Warnings and

Amitriptyline Psychiatry CYP2D6 Precautions

Amivantamab-vmjw Oncology EGFR Indications and Usage,

Amoxapine Psychiatry CYP2D6 Precautions

Amphetamine Psychiatry CYP2D6 Clinical Pharmacology

Anakinra Rheumatology NLRP3 Indications and Usage,

Anastrozole Oncology ESR, PGR Indications and Usage,

Anifrolumab-fnia Rheumatology Gene Signature Clinical Pharmacology,

Arformoterol (1) Pulmonary UGT1A1 Clinical Pharmacology

Arformoterol (2) Pulmonary CYP2D6 Clinical Pharmacology

Aripiprazole Psychiatry CYP2D6 Dosage and

Aripiprazole Lauroxil Psychiatry CYP2D6 Dosage and

Arsenic Trioxide Oncology PML-RARA Indications and Usage,

Articaine and Epinephrine (1) Anesthesiology G6PD Warnings and

 Drug  Therapeutic Area*  Biomarker†  Labeling Sections 

Articaine and Epinephrine (2) Anesthesiology Nonspecific Warnings and

Asciminib Oncology BCR-ABL1 Indications and Usage,

Ascorbic Acid Endocrinology G6PD Dosage and

Atezolizumab (1) Oncology CD274 Indications and Usage,

Atezolizumab (2) Oncology Gene Signature Clinical Studies

Atezolizumab (3) Oncology EGFR Indications and Usage,

Atezolizumab (4) Oncology ALK Indications and Usage,

Atezolizumab (5) Oncology BRAF Indications and Usage,

Atomoxetine Psychiatry CYP2D6 Dosage and

Avapritinib (1) Oncology PDGFRA Indications and Usage,

Avapritinib (2) Oncology KIT Clinical Studies

Avatrombopag (1) Hematology F2 Warnings and

Avatrombopag (2) Hematology F5 Warnings and

 Drug  Therapeutic Area*  Biomarker†  Labeling Sections 

Avatrombopag (3) Hematology PROC Warnings and

Avatrombopag (4) Hematology PROS1 Warnings and

Avatrombopag (5) Hematology SERPINC1 Warnings and

Avatrombopag (6) Hematology CYP2C9 Clinical Pharmacology

Avelumab Oncology CD274 Clinical Studies

Azacitidine (1 Oncology CBL Clinical Studies

Azacitidine (2) Oncology PTPN11 Clinical Studies

Azacitidine (3) Oncology RAS Clinical Studies