Off-label use refers to using an FDA-approved drug for an unapproved use. After the FDA approves a drug, a doctor may legally prescribe the drug for an unapproved use if they believe it is medically appropriate. Reasons for off-label use might include the lack of an approved drug for your disease or medical condition or lack of benefits from other approved treatments. Off-label use might include: using a drug for a disease or condition for which it is not approved, giving a drug in a different way, or prescribing a drug in different dosages than what is recommended. While doctors can prescribe drugs for off-label use, drug manufacturers are prohibited from recommending any uses other than what the FDA has approved.