Speak up! Report your side effects.

Most adverse drug reactions go unreported. This is a public health matter because without knowledge on potential safety issues, the FDA’s ability to address a particular drug product concern may be delayed or remain unaddressed.

Disclaimer & Consent (Please Read): By completing the fields below, you are permitting Safest Drug to submit a report on your behalf to the U.S. Food & Drug Administration (FDA). Your information will remain confidential within Safest Drug and some information you provide may be used to track key metrics (example: total number of reports submitted to the FDA in a given month) which track our productivity or communicate our impact in helping consumers to file FDA reports. By clicking submit below you are also permitting Safest Drug to contact you if we need additional information or need to clarify the information you provided. This is a free service and at no time will you be charged. Depending on the details you would like to provide, it may take approximately 3 to 15 minutes to complete this report. You may want to have the medication in front of you to ensure easier reporting of the name(s) of the medication and manufacturer. Helpful demographic data, like age or race, is also being collected but that information is optional to provide. After submitting, a member of the Safest Drug team will email or call you to confirm your report is being submitted to the FDA (or) to gather additional information. The FDA may also contact you to confirm receipt of your report and if you prefer to file a report directly with the FDA, click here.

Your name *
Your name
Are you reporting a drug reaction(s) that happened to you (or) to someone you know? *
If you are submitting a report on behalf of someone else, are they aware and have provided their consent? *
Provide the name as it appears on the box, bottle or package. Include as many names as you see. If you need to report more than two medications, please email us at contact@safestdrug.org
Be as descriptive as you can. Once we submit your report to the FDA, one of their representatives may reach out to you for more information, as necessary.
Is this medication still being consumed? *
If you don't know exactly, please provide your best guess (example: I took the medication for about 2 days).
Did any of the following occur as a result, or possible result, of taking this medication? *
Please check all that may apply.
Tell us the condition or illness your healthcare provider was hoping to treat by prescribing this medication to you.
Gender of person experiencing the medication reaction
(Optional)
(Optional)
Date of Birth for person experiencing the medication reaction
Date of Birth for person experiencing the medication reaction
(Optional)
Ethnicity of the person experiencing the medication reaction
(Optional)
Race of the person experiencing the medication reaction
Your phone number
Your phone number
(Optional, if you are providing an email address)

Additional Information about Side Effect Reporting

We use the term “side effects” because it is the more commonly used, but the FDA is more interested in your “adverse drug reactions”. As a matter of fact, those who work in the healthcare industry consider the two terms to be very different. Side effects may be expected and temporary, whereas adverse drug reactions may be unexpected and more serious.

Regardless, all medications pose the risk of side effects or adverse drug reactions and some may need to be reported.

So, if you need to report a suspected or confirmed adverse drug reaction that is concerning to you (or, “undesired” per the FDA’s advisory), then you have the right to report this. For all reports you submit to us or to the FDA, we strongly advise for you to share with your prescribing healthcare provider too.