Prepare your questions
If a product has caused a problem
Urgent symptoms need urgent care. A report can follow; it is a separate step.
In the US, medicines are reviewed by the Food and Drug Administration, known as the FDA.
Get urgent help for severe symptoms
Use this as a prompt to seek help, rather than a way to diagnose the cause.
Severe allergic symptoms
- US health guidance names loss of consciousness, swelling of the face or tongue, and difficulty swallowing or breathing among the signs of a severe allergic reaction.
- For severe allergic symptoms, MedlinePlus directs people to phone 911 or seek care at the closest emergency room.
Signs of a severe infection
- The CDC (Centers for Disease Control and Prevention) says sepsis is a medical emergency in which the body has an extreme response to infection.
- Confusion, extreme pain, fever or feeling very cold, and shortness of breath are among the signs listed by the CDC.
After urgent care
Bring the product details to the conversation
- What did the label call the product?
- When was it used, and when did the problem begin?
- What else was being taken?
- Who supplied it, and what records do you have?
Give the doctor or other licensed health professional the clearest account you can. Keep the original wording available.
Tell the FDA about the problem
MedWatch is the FDA system for reporting problems with medical products.
- Patients can submit a MedWatch report themselves without a fee.
- A reported problem does not by itself prove a medicine caused it, and reports cannot show how often a problem occurs.
- Keep a copy of what you report.