What it is
MedWatch is the FDA's program for collecting reports about problems with medical products. An adverse event is an unwanted or harmful health effect that happens after using a product or treatment. Reports can also cover product quality problems or mistakes in how a product was used.
Anyone can submit a report. You don't have to be a doctor, and you don't have to be certain the product caused the problem. The FDA uses reports to look for patterns and to decide whether more safety review is needed.
A report is not a medical visit, a complaint that guarantees a response, or a legal claim. The FDA may not contact you about an individual report. Your health care comes first, so get medical attention for any health concern before you think about paperwork.
How it’s traditionally been approached
Traditionally, health professionals, manufacturers and the public have all been able to send safety reports to the FDA. The FDA describes online and paper ways to submit one. Check the FDA's own website for the current forms and instructions.
A report usually describes who was affected, the product or treatment involved, what happened, when it happened, and what care followed. Many people also include the clinic's name and any product or lot information they were given. Keeping your own notes and records can make this easier.
MedWatch is separate from a state medical board. A state medical board oversees licensed clinicians in that state, and people often contact it about a provider's conduct. Some people file with both. Each has a different role, so ask each one what it can and cannot do.
How the right provider may help
A licensed clinician may help in two ways. First, they can evaluate your symptoms and treat them. Second, they can help you document what happened. Many people start with their primary care clinician, or with an urgent or emergency team if symptoms are serious.
At a visit, you can bring your records. These include consent paperwork, receipts, product names, dates, and photos or notes about symptoms. Questions to ask include: What do you think is going on? What follow-up is appropriate? Can you help me document this for a safety report? Should I see a specialist?
Only a licensed clinician can decide what care is appropriate for you after an evaluation. Some providers in regenerative and wellness medicine may offer follow-up, but you can also seek a second opinion elsewhere. Ask any provider directly about the FDA status of products they use.
The whole-person view
Having a bad reaction or feeling let down by a treatment can be stressful. Body and mind affect each other, so worry, anger or sleeplessness can make physical symptoms feel harder to cope with. Looking after both your physical health and your emotional well-being is a reasonable approach.
Somatic Experiences offers body-based support that some people find helpful when stress is held in the body. Therapists.plus connects people with talk therapy for processing difficult experiences. Neither replaces medical care, and you can use them alongside your clinician's guidance.
Somatic Experiences: nervous system regulation →Somatic Experiences: embodiment and movement →Therapists.plus: mind body connection →
Keep in mind
- Blood-forming stem cell transplants from cord blood or bone marrow are the clearly FDA-approved use, for certain cancers and blood disorders. Stem cell, MSC, bone marrow aspirate, adipose-derived, umbilical cord, Wharton's jelly and exosome products marketed for joints, back pain, sports injuries, skin, anti-aging or hair loss are generally not FDA-approved for those uses, and the FDA has warned the public about unapproved clinics and products.
- Reported risk categories include infection, immune reaction, tumor formation at the injection site, and permanent injury from unapproved products injected into the eye or spine. Red flags include guarantees of results, 'cure' or 'regrow' language, refusing to name the product or its FDA status, pressure to decide quickly, and discouraging a second opinion. Treatment abroad carries materially higher risk, because standards differ and a complication is harder to address from a distance. A vetted domestic provider is a safer first step, and a registered trial on ClinicalTrials.gov is a route to legitimate experimental care.
- Informed consent should cover the exact product and its FDA status, specific risks, a realistic chance of benefit, alternatives including doing nothing, the total cost, and your right to walk away. This page is not a consent form, and it is not medical, legal or financial advice.
- Licensed professionals should guide care for any serious condition. For emergencies, call 911. In a crisis, call or text 988.
Not sure where to start? Answer a few gentle questions and choose who you’d like to hear from.
Frequently asked questions
What is FDA MedWatch adverse event reporting?
FDA MedWatch adverse event reporting is the FDA's program for receiving reports of harmful effects or product problems linked to medical products. Patients, caregivers and health professionals can all submit reports. The FDA uses them to look for safety patterns.
Who can file a MedWatch report?
Anyone can file one, including patients, family members and clinicians. You don't need proof that the product caused the problem. Just describe what happened as accurately as you can.
What information should I have ready for a report?
It helps to have the product or treatment name, the clinic or provider, the dates, a description of your symptoms, and the care you received afterward. Any product or lot information you were given is useful too. Copies of paperwork and receipts can help you remember details.
Should I report a problem after a stem cell treatment?
Yes, you can. Most stem cell products marketed for joints, back pain, skin, anti-aging or hair loss are generally not FDA-approved for those uses, so reports can be especially valuable. Seek medical care first if you are unwell.
What is the difference between MedWatch and a state medical board?
MedWatch collects safety reports about medical products for the FDA. A state medical board oversees licensed clinicians in that state and handles concerns about their conduct. You can contact both, and each can explain what it does with your information.
Will the FDA contact me or fix my problem after I report?
Not necessarily. The FDA may not follow up on individual reports, and a report is not a medical visit or a legal claim. Contact a licensed clinician for care, and ask a qualified professional about any legal questions.
Educational resource. Safe Stem Cells shares general information and connects people with independent providers. It is not medical advice, diagnosis or treatment. Talk with a licensed professional about your health.