- You can tell the U.S. Food and Drug Administration (FDA) about a problem that a drug caused or might have caused.
- People from the U.S. and other countries can file FDA reports.
- You can file a report for yourself or your child, even if your child is 18 or older.
- You do NOT need to give your child’s name to the FDA or to the drug manufacturer.
- The FDA may require stronger warnings on drug labels, or take other actions, if many people report their problems to the FDA.
Step 1 — Collect Your Information
Ask yourself the following questions. Then go to Step 2 to complete the FDA form:
- Drug: What drug did the patient (you or your child) get? For a list of drug names, see Testosterone Drugs or GnRHa Drugs. If you don’t know the exact name, then just mention the drug type: Testosterone or Gonadotropin-Releasing Hormone Analog (GnRHa) (“puberty blocker”) or other drug.
- Doctor: Who prescribed the drug? (An endocrinologist, psychiatrist, pediatrician, etc.?)
- Mental Health: Did the patient have any mental health conditions diagnosed before or after the drug was prescribed, such as autism or attention deficit disorder? Did the drug make the patient’s mental health worse?
- Physical Health: Did the patient have any physical health conditions diagnosed before or after the drug was prescribed, such as Polycystic ovary syndrome (PCOS), Endometriosis or Classic congenital adrenal hyperplasia (CAH)? Did the drug make the patient’s physical health worse?
Step 2 — Go to the FDA Site
Go to the FDA’s MedWatch Voluntary Reporting site to file a report online or download a PDF that you can print and mail to the FDA. If you’re getting the PDF, select Form 3500. Click here to get to the FDA site.
Step 3 — Start Filling in the Form
Begin to fill in the FDA form. If the patient did not yet suffer an adverse drug effect, but you think it was inappropriate for the doctor to prescribe the drug, then just skip this section and go to the next part of the form.
Step 4 — Tell What Happened
On the first screen, a box says: Tell us what happened and how it happened:* You must provide information here.
For example: Tell the FDA if the patient did not get enough testing, screening or counseling before getting transition drugs. Tell the FDA if the patient’s mental or physical health problems got worse. Here are some examples:
Step 5— Check the Blue Box
At the bottom of the first screen, check the top blue box to indicate that the problem involved a drug (instead of a medical device):
Step 6 — Don’t Give Your Name to Drug Company?
Continue to fill out the FDA form. On the fourth screen, the FDA will ask for your contact information. Enter a name. Below that, there is an option to enter your email address and phone number. You are not required to provide your phone or email. The FDA will accept your form without verifying your legal name, phone or address.
At the bottom of the fourth screen, there will be questions asking if you reported your problem to the drug manufacturer and if you want to identify yourself to the drug manufacturer. This is your choice. If you do NOT want to identify yourself to the drug manufacturer, then check the box to say NO. You can still submit the form to the FDA.
A warning will pop up. You can just close it and continue without agreeing to give your name to the drug manufacturer.
Step 7 — SAVE or PRINT
Proceed to the final screen where you can review your information. SAVE or PRINT a copy for yourself. Then submit it to the FDA.