What does it mean when a medication is used off-label?

When a medication is used off-label, it refers to the practice of prescribing it for indications, doses, or patient populations that are not specifically approved by regulatory bodies such as the FDA. This means that while the medication has been approved for certain uses, healthcare providers may choose to use it in other ways based on their professional judgment, clinical experience, or emerging evidence that suggests its effectiveness for different conditions.

This practice is not uncommon in medicine, especially in areas where there may be limited treatment options, or for conditions where research suggests that an approved medication may still provide benefit despite not being formally recognized for that use. Off-label prescribing can be particularly common in fields like psychiatry and pediatrics, where clinical needs may not always align with the existing labeled indications of medications.

In contrast, options relating to expiration dates, different forms of administration, or combining therapies refer to other aspects of medication usage and do not pertain to the concept of off-label use.