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How to Share Adverse Drug Reaction Info

FDA updates its online tool for consumers

How to use FDA's new drug reaction tool

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A new online tool provides more user-friendly access to data on medications.

If you suspect you might be having a bad reaction to a medication, the Food and Drug Administration (FDA) just made it easier to compare your symptoms with others who’ve had similar experiences.

The agency has updated an online tool to provide consumers, health care providers and researchers more user-friendly access to data on drug reactions, medication errors and product quality complaints.

Established in the 1960s, the FDA’s Adverse Event Reporting System (FAERS) database is a collection of reports from consumers, the pharmaceutical industry and health care providers. It’s part of the program the FDA uses to monitor the safety of drugs and biologic products, such as blood or vaccines.

The FDA cautions that information in FAERS has its limitations. Because the FDA hasn’t verified the entries in the database, there is no guarantee that a particular product actually caused a patient’s symptoms. The agency advises patients with medication concerns to check the FAERS data, but then also to talk with their health care professionals

The new system replaces a far more complicated series of spreadsheets, which were difficult for consumers to interpret. With the new tool, anyone can search by a patient’s age, by drug or biologic, by the type of reaction, or by year. For example, someone who gets nauseous after taking a drug can find out how many people have reported the same symptom in a given year.

“The database is used as a surveillance tool to help the agency look for new safety concerns that might be related to a marketed product,” FDA Commissioner Scott Gottlieb said in a statement.

The FDA regularly examines the reaction data as part of its routine safety monitoring. If a particular concern is repeated often enough or if something looks especially serious, the potential safety issue is referred to the agency's Center for Drug Evaluation and Research for further evaluation. FAERS is one of many databases that help alert the agency to possible problems associated with a drug or other medical product. 

If the safety concern warrants it, the FDA may act to improve a product’s safety and protect the public health. That might involve updating a product’s labeling, restricting the use of the drug, communicating new safety information to the public or, in rare cases, removing a product from the market. 

FDA officials hope the easier-to-use, more transparent database will encourage more consumers, health care professionals and others to contribute more information about adverse drug reactions. 

Janet Woodcock, director of the FDA Center for Drug Evaluation and Research, said the reports from the public and medical professionals are valuable components of the FDA's continuing assessments of drugs and other medical products.

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