Off-label drug use is when a doctor prescribes a drug for a patient in a different way than what is included in the FDA-approved labeling for that drug.

Once a drug is approved by the FDA, the FDA typically designates on the label what conditions it was approved for.

In general, doctors are permitted to prescribe a drug “off-label” for a condition or symptom not included on the approved FDA label, if deemed medically appropriate for the patient.