Has your healthcare provider ever talked to you about using an FDA-approved drug for an unapproved use (sometimes called an “off-label” use) to treat your disease or medical condition?

Both prescription drugs and over-the-counter drugs (OTCs) can be used in off-label ways, although most studies of off-label use focus on prescription drugs. Off-label use is very common and generally legal …

Jul 9, 2025 · Off-label use means using an FDA-approved medication in a way that hasn’t been approved by the FDA. For example, a medication may be used for a different health condition or at a …

Jun 5, 2025 · Off-label use is when you use a medication in a different way than what the Food and Drug Administration (FDA) approved it for. This includes taking a medication for a different condition, …

May 14, 2025 · Off-label use refers to prescribing a medication for a different purpose than those formally approved by the FDA and found in the package labeling of the drug. The FDA approves …

Feb 3, 2023 · Is it OK to use a medication off-label? Learn about possible benefits, risks and unintended consequences of demand spikes.

Off-label practice occurs when a drug is prescribed, dispensed, and administered on other terms than the ones specified in the SmPC by the MAH. Therefore, it embraces the uses of a medicinal drug …

Nov 19, 2025 · In simple terms, “off-label” means that a doctor prescribes a medication for a use that is not included in the official FDA approval of that medication. This does not mean the use is unsafe or …

Sep 4, 2015 · When your doctor prescribes a drug for you, you probably assume — and with good reason — that it is an FDA-approved treatment for your condition. That may or may not be the case. …

A Legal Medical Practice: Off-label use refers to a doctor legally prescribing an FDA-approved drug for a purpose, patient group, or dosage not listed on the drug's official label.