Faster Information from FDA Means Improved Drug Safety for Patients

FDA is making it easier and faster for health care professionals and patients to get the most up-to-date drug safety information on the more than 18,000 drugs available on our website. Their improved Drug Safety Labeling Changes Program enables FDA to post the latest safety information about a medicine almost at the same time the agency approves a change, as opposed to once a month.

For each FDA-approved drug, the agency provides detailed prescribing information, known as product “labeling.” Labeling helps those who prescribe medications understand key information about the drug, such as how much to prescribe, how often a patient should take a drug, which conditions the medicine treats, and what safety precautions should be followed for patients taking the drug. Safety information can change multiple times over the lifetime of a drug as FDA learns about new risks, interactions with other medications and side effects. After we become aware of new safety information, changes to the drug product labeling may be required. The public can access this information as well, now in a searchable database. Key in the drug name and get a comprehensive listing of the labeling changes related to safety for that product.