Skip to main content
          Skip to FDA Search
          Skip to in this section menu
          Skip to footer links


U.S. flagAn official website of the United States government

					Here’s how you know
          			Dot gov**The .gov means it’s official.**Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.
							      SSL**The site is secure.** The **https://** ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 
			U.S. Food and Drug Administration
				
        Search
            Menu
							
						Search FDA
									
									Submit search 
		Featured
							Contact FDA
	                FDA Guidance Documents
	                Recalls, Market Withdrawals and Safety Alerts
	                Press Announcements
	                Warning Letters
	                Advisory Committees
	                En Español

					Products
            Food
							Drugs
							Medical Devices
							Radiation-Emitting Products
							Vaccines, Blood, and Biologics
							Animal and Veterinary
							Cosmetics
							Tobacco ProductsTopics
            About FDA
							Combination Products
							Regulatory Information
							Safety
							Emergency Preparedness
							International Programs
							News and Events
							Training and Continuing Education
							Inspections and Compliance
							Science and ResearchInformation For
            Consumers
	            Patients
	            Industry
	            Health Professionals
	            Federal, State and Local Officials 
 In this section:

        Learn About Expanded Access and Other Treatment Options

Understanding Unapproved Use of Approved Drugs "Off Label" Home
          For Patients
          Learn About Expanded Access and Other Treatment Options
          Understanding Unapproved Use of Approved Drugs "Off Label"Learn About Expanded Access and Other Treatment Options Understanding Unapproved Use of Approved Drugs "Off Label"
  	
        Share
    Post
    Linkedin

    Email
    PrintPill Bottle and Prescription PadHas 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?It is important to know that before a drug can be approved, a company must submit clinical data and other information to FDA for review. The company must show that the drug is safe and effective for its intended uses. “Safe” does not mean that the drug has no side effects. Instead, it means the FDA has determined the benefits of using the drug for a particular use outweigh the potential risks.When you are prescribed a drug for its approved use, you can be sure:That FDA has conducted a careful evaluation of its benefits and risks for that use.The decision to use the drug is supported by strong scientific data.There is approved drug labeling for healthcare providers on how to use the drug safely and effectively for that use.The approved drug labeling for healthcare providers gives key information about the drug that includes:The specific diseases and conditions that the drug is approved to treat.How to use the drug to treat those specific diseases and conditions.Information about the risks of the drug.Information that healthcare providers should discuss with patients before they take a drug.Some drugs may also have labeling information for patients such as Medication Guides, Patient Package Inserts and Instructions for Use.Why might an approved drug be used for an unapproved use?From the FDA perspective, once the FDA approves a drug, healthcare providers generally may prescribe the drug for an unapproved use when they judge that it is medically appropriate for their patient. You may be asking yourself why your healthcare provider would want to prescribe a drug to treat a disease or medical condition that the drug is not approved for.  One reason is that there might not be an approved drug to treat your disease or medical condition.  Another is that you may have tried all approved treatments without seeing any benefits.  In situations like these, you and your healthcare provider may talk about using an approved drug for an unapproved use to treat your disease or medical condition.What are examples of unapproved uses of approved drugs?Unapproved use of an approved drug is often called “off-label” use. This term can mean that the drug is:Used for a disease or medical condition that it is not approved to treat, such as when a chemotherapy is approved to treat one type of cancer, but healthcare providers use it to treat a different type of cancer.Given in a different way, such as when a drug is approved as a capsule, but it is given instead in an oral solution.Given in a different dose, such as when a drug is approved at a dose of one tablet every day, but a patient is told by their healthcare provider to take two tablets every day.If you and your healthcare provider decide to use an approved drug for an unapproved use to treat your disease or medical condition, remember that FDA has not determined that the drug is safe and effective for the unapproved use.Questions you may want to considerIf your healthcare provider is thinking about using an approved drug for an unapproved use, you may want to ask your healthcare provider questions like these:What is the drug approved for?Are there other drugs or therapies that are approved to treat my disease or medical condition?What scientific studies are available to support the use of this drug to treat my disease or medical condition?Is it likely that this drug will work better to treat my disease or medical condition than using an approved treatment?What are the potential benefits and risks of treating my disease or medical condition with this drug?Will my health insurance cover treatment of my disease or medical condition with this drug?Are there any clinical trials studying the use of this drug for my disease or medical condition that I could enroll in?Resources For YouFDA Approved Medication GuidesDrugs@FDA DatabaseDailyMed

                                                                                  Content current as of:
      02/05/2018Understanding Unapproved Use of Approved Drugs "Off Label"
 
 Footer Links
    FDA Archive
          About FDA
          Accessibility
      Visitor Information
          Website Policies / Privacy
          No FEAR Act
          Vulnerability Disclosure Policy
      FOIA
          HHS.gov
          USA.gov
    Contact FDA
      Follow FDA on Facebook
      Follow FDA on X
      Follow FDA on Instagram
      Follow FDA on LinkedIn
      View FDA videos on YouTube
      Subscribe to FDA RSS feeds
    FDA Homepage
    Contact Number
      1-888-INFO-FDA (1-888-463-6332) Back toTop