Dietary Supplements: 

Report Adverse Events to FDA

What is an Adverse Event?

It is possible to experience an adverse 

event, also known as a side effect or bad 

reaction, while using dietary supplements. 

Adverse events may occur immediately 

or can happen sometime later and can 

range from less serious reactions to 

life-threatening illnesses, such as:

• Itching, rash, hives, or wheezing

• Fatigue or appetite loss 

• Severe, persistent nausea, vomiting, 

diarrhea, or abdominal pain

• Difficulty urinating, decreased urination, 

or dark urine

• Marked mood, cognitive, or 

behavioral changes 

• Severe joint or muscle pain 

• Yellowing of the skin or eyes 

• Abnormal bleeding from the 

nose or gums 

• Blood in urine, stool, or vomit

• Throat, lip, or tongue swelling 

• Low blood pressure, fainting, 

chest pain, or shortness of breath

• Stroke (slurred speech, one-sided 

weakness of face, arm, leg, or 

blurry/loss of vision)

Dietary supplements can be beneficial 

to your health, but they can also have 

unexpected consequences, especially if 

you start taking a new product, take 

supplements in high doses, take multiple 

supplements, or take supplements 

instead of or in addition to medications.

Before deciding to take a dietary 

supplement, always talk to your 

healthcare professional.

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Why Should I Report an Adverse Event?

By law, FDA does not have the authority to 

approve dietary supplements before they are 

sold to the public. In fact, in most cases, FDA 

isn’t even notified when a dietary supplement 

is introduced to the market. However, when 

you report an adverse event associated with 

a dietary supplement, FDA can use the 

information you provide to help identify 

potentially dangerous products and possibly 

remove them from the market.

In some cases, a single adverse event report 

can be very helpful to FDA in investigating 

and taking action to protect other consumers 

from unsafe products. That’s why it’s so 

important for you to notify FDA about any 

adverse reactions to a dietary supplement.

To learn about dietary supplement-related 

actions that FDA has taken to protect 

the public health, visit: www.fda.gov/

dietarysupplements. 

What Should I Do if I Experience an 

Adverse Event?

If you are taking a dietary supplement and 

experience an adverse event, immediately 

stop using the product and seek medical 

care or advice.

You should also submit a report to FDA 

through either:

• The Safety Reporting Portal at 

www.safetyreporting.hhs.gov.

• An FDA Consumer Complaint 

Coordinator. You can find the phone 

number for your local Consumer 

Complaint Coordinator at 

www.fda.gov/consumer-complaintcoordinators or by calling FDA’s 

SAFEFOOD Information Line at 

1-888-SAFEFOOD (1-888-723-3366). 

Even if you aren’t sure the dietary supplement 

caused the adverse event, it’s always better 

to report it to FDA. Try to provide as much 

information as possible. Complete reports 

are the most useful, but even pieces of 

information can be helpful. 

Experiencing an Adverse Event? 

1: STOP taking the supplement immediately

2: SEEK medical care

3: REPORT the adverse event to FDA

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