definition of off label: For medications, the term “off-label” refers to when a physician prescribes a medication for use in a condition that is not included in FDA-specified uses for that medication. Physicians are allowed to use personal judgment and prescribe medication for a non-indicated or “off-label” use when the physician thinks that the medication may help someone with a different condition than what the FDA has indicated (see indications). Many medications are used off-label to treat conditions that are not indicated by the FDA. Typically, case studies then report if the medications worked in such off-label uses. If they worked, then larger clinical trials are performed to see if the medication is able to be helpful for most people with that specific condition. When there are enough positive clinical studies, the FDA may revise indications for the drug to include the new condition.