How to Report an ADR
An ADR, or Adverse Drug Reaction, is an unwanted and unintended effect that a drug has on a patient. You can report an ADR on the Internet to the Food and Drug Administration via the online FDA MedWatch form on their website. These reactions can be anywhere from mild or severe, but if you are experiencing or have experienced an ADR, it may be important to report it to make sure that safety and quality concerns about the drug are considered.
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Instructions
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Open your Internet browser and go to the FDA's Adverse Drug Reactions reporting page (AccessData.fda.gov/scripts/medwatch/medwatch-online.htm).
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Click on the blue button labeled "Begin" in the right sidebar.
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Enter your patient information, such as Patient ID number, date of birth, sex and weight in the appropriate fields, and click the "Next Section" button at the bottom right of the page.
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Enter the required information regarding the Adverse Drug Reaction incident in the provided fields, such as problem, date of incident, description of incident, outcome, tests taken, and relevant health history. Click the "Next Section" button.
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State whether the product that cause the adverse effect is available for testing. Click the "Next Section" button.
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Enter the information about the drug that caused the incident into the provided fields, such as name, strength and manufacturer of the drug, as well as the dose taken, times, and method it was taken in. Click the "Next Section" button.
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Enter a list of any other drugs taken during the same period into the provided text field. Click the "Next Section" button.
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Enter your contact information as the reporter of the incident, such as name, phone number and email as well as your doctor's name and contact information.
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Click the "Submit" button to report your ADR.
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