FDA Logo--links to FDA home page
U.S. Food and Drug Administration
HHS Log--links to Department of Health and Human Services website

FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA

horizontal rule

Consumer Update

red envelope Sign up for Consumer Updates by e-mail

RSS feed RSS feed for Consumer Updates [what is RSS?]

Main Consumer Health Information Page

FDA 101: How to Use the Consumer Complaint System and MedWatch

Printer-friendly PDF (373 KB)
Cover page of PDF version of this article, including photo of a telelphone and a laptop with the MedWatch reporting page on the screen.

On this page:

If you have a complaint about a product regulated by the Food and Drug Administration (FDA), the agency wants to hear about it.

FDA offers a number of ways to report a complaint. Two of the main reporting systems available to consumers are the Consumer Complaint Reporting system and MedWatch.

1. Consumer Complaint Reporting

FDA's Consumer Complaint Coordinators (CCC's) located in FDA offices throughout the United States and Puerto Rico will listen, document your complaint about an FDA-regulated product, and follow up as necessary. Consumers should report problems to the CCC for their geographic region. (See the accompanying list of CCC's. The list is also on FDA's Web site at www.fda.gov/opacom/backgrounders/complain.html.)

Some examples of complaints that your CCC wants to hear about are

back to top

Reporting Problems Can Spur Action
If a person reports an illness or injury that appears likely to be caused by an FDA-regulated product, FDA acts immediately. Depending on the seriousness of the problem, an FDA investigator may visit the person who made the complaint, collect product samples, and initiate inspections.

"Just a few complaints can make a difference," says Joan Trankle, FDA's National CCC. For example:

Complaints of a less serious nature, or those that appear to be isolated incidents, are monitored and the information is used during a future inspection of a company to help FDA identify problem areas in a production plant. The complaints are also discussed with company management during these inspections.

back to top

2. MedWatch Reporting

MedWatch is for reporting any adverse events (unexpected side effects) that occur while using human health care products and some other FDA-regulated products such as

When FDA approves a medical product, the agency has determined that the benefits of the product outweigh the risks. "But every product that FDA approves carries some risk," says Norman Marks, M.D., Medical Director of FDA's MedWatch Program. "Sometimes there are risks that only come to light after a medical product gets on the market and is used in a larger number of patients, for a longer period of time, and in patients whose health characteristics are different from those of the patients studied before approval." So continued monitoring of adverse events is essential and depends on reporting of these events to FDA so they can be entered in MedWatch.

Every MedWatch report is important and is recorded in an FDA database for review and comparison to similar previous reports. When added together, reports can signal a safety problem and lead to an FDA action to protect the public, says Marks. "Reporting can help you, a family member, or someone else avoid harm, serious illness, or even death."

back to top

How to Report to MedWatch
Reporting to MedWatch is easy, confidential, and secure. You provide information about your experience on a MedWatch form. FDA encourages you to have your health care professional either complete the form for you or help you complete the form yourself. "Health care professionals have test results and other clinical information that will help us better evaluate the report," says Marks.

Reporting by health care professionals is voluntary. If they choose not to report, or if you'd rather file the report yourself, you may use one of these methods:

If you or your health care professional does not want to complete a MedWatch report, you may report a problem with a health care product to your CCC. "There are times when consumers want to explain their problem and have us record the complaint," says Trankle. "This gives us the advantage of being able to ask questions and obtain important information that we might not get if they were filling out a MedWatch report."

horizontal rule

CCC's and MedWatch are for reporting problems; neither provides medical advice. If you experience an adverse event, you should contact your health care professional first and then report the problem to FDA.

horizontal rule

back to top

What Happens After Reporting to MedWatch?

FDA actions may include

back to top

Problems to Report to MedWatch
MedWatch is for reporting four types of problems with human health care products. Examples of each are shown here.

1. Serious adverse event

2. Product quality problem

3. Product use error

4. Problem with different manufacturer of same medicine

  • death
  • life-threatening situation
  • requires admission to hospital or longer-than-expected hospital stay
  • permanent disability
  • birth defect, miscarriage, stillbirth, or birth with serious disease
  • requires medical care to prevent permanent damage
  • suspected counterfeit product
  • potentially contaminated product indicated by suspicious odor or unusual color
  • inaccurate or unreadable product labeling
  • mixing up products with similar drug names or packaging
  • taking wrong dose of a drug because of confusing dosing instructions on label
  • not getting same results from a generic drug as a brand name drug, or from another generic

Reporting Emergencies

If you have a medical emergency, call your health care professional for medical advice. If you wish to report a serious, life-threatening adverse event related to the use of an FDA-regulated product, call FDA’s 24-hour emergency line at 301-443-1240 or call your local FDA Consumer Complaint Coordinator.

back to top

FDA Consumer Complaint Coordinators / Regions and Telephone Numbers
(as of April 30, 2008)

  • Alabama 866-289-3399
  • Alaska 425-483-4949
  • Arizona 949-608-3530
  • Arkansas 214-253-5200, ext 5233
  • California (Northern) 510-337-6741
  • California (Southern) 949-608-3530
  • Colorado 303-236-3044
  • Connecticut 781-596-7700
  • Delaware 215-597-9064
  • District of Columbia 410-779-5713
  • Florida 866-337-6272
  • Georgia 404-253-1169
  • Hawaii 510-337-6741
  • Idaho 425-483-4949
  • Illinois 312-353-7840
  • Indiana 313-393-8100
  • Iowa 913-752-2440
  • Kansas 913-752-2440
  • Kentucky 513-679-2700, ext 124
  • Louisiana 866-289-3399
  • Maine 781-596-7700
  • Massachusetts 781-596-7700
  • Michigan 313-393-8100
  • Minnesota 612-758-7221
  • Mississippi 866-289-3399
  • Missouri 913-752-2440
  • Montana 425-483-4949
  • Nebraska 913-752-2440
  • Nevada 510-337-6741
  • New Hampshire 781-596-7700
  • New Jersey 973-331-4917
  • New Mexico 303-236-3044
  • New York 866-446-9055
  • North Carolina 404-253-1169
  • North Dakota 612-758-7221
  • Ohio 513-679-2700, ext 124
  • Oklahoma 214-253-5200, ext 5233
  • Oregon 425-483-4949
  • Pennsylvania 215-597-9064
  • Rhode Island 781-596-7700
  • South Carolina 404-253-1169
  • South Dakota 612-758-7221
  • Tennessee 866-289-3399
  • Texas 214-253-5200, ext 5233
  • Utah 303-236-3044
  • Vermont 781-596-7700
  • Virginia 410-779-5713
  • Washington 425-483-4949
  • West Virginia 410-779-5713
  • Wisconsin 612-758-7221
  • Wyoming 303-236-3044
  • Puerto Rico & U.S. Virgin Islands 800-332-0127

This article appears on FDA's Consumer Health Information Web page (www.fda.gov/consumer), which features the latest on all FDA-regulated products. Sign up for free e-mail subscriptions at www.fda.gov/consumer/consumerenews.html.

back to top

For More Information

Your Guide to Reporting Problems to FDA

MedWatch Reporting by Consumers

Sign Up for Free MedWatch Safety Alerts by Email

back to top

Date Posted: June 10, 2008

horizontal rule