What pharmacogenomic markers are FDA‑approved for ADHD? 

There are some pharmacogenomic (PGx) markers included in FDA drug labels that relate to ADHD treatments, though very few are full “companion diagnostics,” and many are about metabolism rather than guaranteeing a treatment outcome.

FDA‑Approved PGx Biomarkers Relevant to ADHD Treatments 

Here are what the regulatory labels currently note: 

• The CYP2D6 gene is one of the few pharmacogenomic markers the FDA acknowledges in ADHD drug labeling. Atomoxetine (a non‑stimulant ADHD medication) is metabolised by CYP2D6. The drug label states that poor metabolisers of CYP2D6 have higher drug exposures (higher plasma concentrations, higher area under the curve) and increased risk of adverse effects. Dosage adjustments and careful monitoring are recommended in such cases.  

• Viloxazine (branded Qelbree in the U.S.) also appears in the FDA Table of Pharmacogenomic Biomarkers in Drug Labeling due to its interaction with CYP2D6 (i.e., how it is metabolised). The label indicates differences in exposure in CYP2D6 poor metabolisers. 

• Amphetamine‑type medications are also listed in the FDA pharmacogenetic associations table: there is an acknowledged possibility that CYP2D6 poor metaboliser status may affect systemic concentration and risk of adverse reactions. However, the label does not require genetic testing before prescribing; it is more a warning or advisory.  

What “FDA‑Approved” Means in This Context 

• The presence of PGx information in a drug label does not necessarily mean that genetic testing is required before using the drug; often it’s “recommended,” or “consider in certain populations,” or “dose adjustment may be needed.”  

• Many of the markers relate to pharmacokinetics (how the body breaks down or clears the drug) rather than guaranteeing how well someone will respond (pharmacodynamics). For example, CYP2D6 variation changes drug levels, which might influence side effects or how quickly the drug acts but does not assure improved or poorer efficacy on its own.  

Visit providers like ADHD Certify for personal consultations informed by the latest genetic guidance. 

For a deeper dive into the science, diagnosis, and full treatment landscape, read our complete guide to Genetic studies and biomarkers.