The advance of modern medicine has helped human kind on many levels. The age of the average person has been extended, once deadly diseases are now a minor incontinence and medicine heals wounds that was once life altering. However, this doesn’t mean that all medicine is perfect. Even the most tested medicine reacts differently to each individual person. Sometimes these meds have a reaction that isn’t expected and can harm an individual. When this happens, here is How to Report Adverse Drug Reactions.

The Food and Drug Administration (FDA) is the entity that approves all medicine that comes in and out of the USA. This is who will eventually be contacted about the adverse drug reaction. However, this isn’t the first step.

How to Report Adverse Drug Reactions

Step One

Call a doctor. Get to the hospital, clinic, or private physician immediately! When you feel any bad reaction from drugs or medicine, a doctor should immediately be consulted. The reaction could be mild and cause you know harm, but it also could be deadly with long-lasting effects.

Step Two

Talk to the Doctor about what is happening with the drugs. Your doctor should know your complete medical history. He can tell you if the reaction is normal or if there is more action needed. Tell the physician everything that has been happening to you since the effects started.

Step Three

Ask your doctor about FDA’s Adverse Event Reporting System. Have the doctor describe it to you in detail. Make sure your doctor sends in the right paperwork for the drug used. Follow up with your doctor, physician, or health care provider for updates on this report.

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Step Four

Discuss, with your doctor or health care provider, if you need to send the report to the drug manufacturer. If you sent off a report to the FDA, this may not be a necessary step. However, when learning how to report adverse drug reactions properly, it is good to cover all the bases.

Step Five

Send in another report on your own. The FDA has an established process on reporting adverse drug reactions. You can find what is information is required and correct forms by going to the official FDA website. Make sure that the name of the drug, the reaction to the rug, and the dates of the reaction are noted on the forms. You can send the form back via the website or fax it in. The information needed can be found at under Drugs > Guidance, Compliance & Regulatory Information > Surveillance > FDA Adverse Events Reporting System (FAERS)

In Summary, the steps on how to report adverse drug reactions are:

  1. Contact your doctor, physician, or health care provider.
  2. Talk to your Doctor about the reactions you are having.
  3. Ask them to send in a report to the FDA & follow up on updates.
  4. Send a report to the Drug Manufacturer.
  5. Manually send in a report on your own through the FDA website.


About Cary Byrd

eDrugSearch founder, Cary Byrd, has been called an “e-health innovator” by MarketIntellNow, interviewed by top pharmaceutical industry journalists, invited to Matthew Holt’s Health 2.0 Conference and a Consumer Report's health summit, and highlighted on numerous health blogs.

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