What is PharmGKB?

PharmGKB is an NIH-funded resource that provides information about how human genetic variation affects response to medications. PharmGKB collects, curates and disseminates knowledge about clinically actionable gene-drug associations and genotype-phenotype relationships. When using PharmGKB, you will see different types of information. These are detailed in the sections below.

Drug Label Annotations

Drug(opens in new window) label annotations are annotations on medication labels that contain pharmacogenomic(opens in new window) (PGx) information. PharmGKB currently provides U.S., Canadian, European, Swiss and Japanese medication labels with pharmacogenomic information. Drug label annotations are assigned a level of PGx information(opens in new window) including whether they recommend or require testing a patient for a genetic change before giving them the medication.

Medication labels for certain drugs contain advice about how to adjust dose based on genetic information, or information on the possibility of adverse effects in people with certain genetic variants(opens in new window), or a discussion of the proteins involved in breaking down the drug in the body. The U.S. Food and Drug Administration (U.S. FDA) maintains a list of American labels that contain pharmacogenomic information. PharmGKB monitors this list and adds these labels to the website, along with a description of the specific pharmacogenomic information within the label and a PDF version of the label with pharmacogenomic information highlighted. Occasionally PharmGKB finds and annotates labels with pharmacogenomic information not on this list. Labels can also be removed from the U.S. FDA list, and in these cases, PharmGKB notes the removal but maintains the annotation for historical purposes.

The European Union (European Medicines Agency - EMA) and Canada (Health Canada (Santé Canada) - HCSC) do not currently maintain a public list of labels with genetic information, so PharmGKB curators use the FDA list to help determine which international labels to search for genetic information. Canadian labels come from Health Canada's website, while European labels come from European Public Assessment Reports (EPARs) from the European Medicines Agency (EMA). Swiss labels come from Swissmedic and were identified and translated through a text-mining collaboration with the Pharmaceutical Care Research Group (PCRG) at the University of Basel. Japanese labels come from Pharmaceutical and Medical Devices Agency (PMDA), Japan, and were translated through a collaboration with the Japanese Society of Pharmacogenomics.

Drug labels annotations can also be tagged, depending on the type of pharmacogenomic information contained in the label. For example, the Alternate DrugLearn more about the Alternate Drug tag(opens in new window) andDosing InfoLearn more about the Dosing Info tag(opens in new window) tags indicate label annotations which contain recommendations that an alternate drug be selected or a drug’s dosage be adjusted based on a patient’s genotype. More information on our tags can be found here(opens in new window).