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Pharmacogenomics

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Pharmacogenomics studies how genes affect a person’s response to medicines — why a drug helps some people, does nothing for others or causes side effects. Testing is used in clinical care for some medicines and conditions.

According to NHGRI, 14% of FDA-approved drugs in 2022 had a pharmacogenomic testing recommendation, with examples including drugs for depression, pain and the heart, and drugs for breast cancer that carries a receptor called HER2. The FDA publishes a table of drugs whose labels contain pharmacogenomic information.

Pharmacogenomic tests are not available for every drug or condition, and the genomic data they are built on are often unrepresentative of diverse populations, which may limit their accuracy in certain groups. The decision to adjust any drug based on a genetic result is made solely by the doctor or pharmacist.

Where it stands today — maturityApproved for specific uses12
  1. In widespread clinical use
  2. Approved for specific uses
  3. In clinical trials
  4. Preclinical
  5. Concept

Used in clinical care to guide the prescribing of some drugs, but not available for every drug or condition.

  • Testing recommendations in drug labelsApproved for specific uses

    In 2022, 14% of FDA-approved drugs had a pharmacogenomic testing recommendation.1

Status last checked: · What the maturity levels mean

What is it?

Pharmacogenomics is the study of how genes affect a person's response to drugs.

Sources3

How does it work?

Researchers study how variants in genes affect the body's response to drugs, which helps distinguish those who respond to a drug from those who do not.

The FDA publishes a table of drugs whose labels contain pharmacogenomic information, and the markers in it include inherited genetic variants or ones acquired in the tumour.

Sources32

Where is it used today?

Testing is currently used in clinical care to guide prescribing decisions for drugs ranging from antidepressants and painkillers to heart drugs.

An example is breast cancers that carry a receptor called HER2, where the choice of some treatments is based on its presence.

Sources1

Limits and risks

Testing is not yet available for every drug or every condition.

The genomic data used to develop the tests often do not represent diverse populations.

No drug is adjusted or stopped on the basis of a genetic test result without the doctor or pharmacist.

Sources1

Common questions

Can I adjust my own medication after a pharmacogenomic test?

No. The result is one element of the decision, and the doctor or pharmacist decides on any adjustment; testing is also not available for every drug.1

Questions for your doctor

  • Is there a pharmacogenomic test relevant to the drugs I take?
  • How will the test result affect my treatment plan?

References

  1. 1 Health agencies & guidelines · Accessed 2026-10-08
  2. 2
    U.S. FDA. Table of Pharmacogenomic Biomarkers in Drug Labeling. www.fda.gov/drugs/science-and-research-drugs/table-pharmacogenomic-biomarkers-drug-labeling
    Health agencies & guidelines · Accessed 2026-10-08
  3. 3
    MedlinePlus Genetics (NLM). What is pharmacogenomics?. medlineplus.gov/genetics/understanding/genomicresearch/pharmacogenomics/
    Health agencies & guidelines · Accessed 2026-10-08

Review status: Edited content · Last updated:

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