FDA Reporting Program

We’ve submitted a petition to the FDA calling for stronger warnings and safer tapering guidance for SSRIs and SNRIs. Now we need your help.

Just like the Benzodiazepine Information Coalition’s 2017 campaign—which successfully contributed to the FDA issuing a boxed warning for benzos in 2020—we’re asking everyone harmed by SSRI and SNRI withdrawal to submit a report to FDA MedWatch.

We’re hoping this surge in reports will push the FDA to take action.

Your story matters. Your report can make a difference.

📌 Why We’re Focusing on SSRIs and SNRIs for This Reporting Drive

Since antidepressants include many different classes of medications, and SSRIs (Selective Serotonin Reuptake Inhibitors) and SNRIs (Serotonin-Norepinephrine Reuptake Inhibitors) are so widely prescribed, we’ve chosen to focus on withdrawal from SSRIs and SNRIs for this reporting drive.

By concentrating on withdrawal reactions for these two classes, we can build a strong case for pushing safer, more informed deprescribing practices in the future.

While this drive is focused on SSRI and SNRI withdrawal, we remain committed to advocating for safer prescribing and deprescribing of all classes of antidepressants and believe that every type deserves attention.

Thank you for your support in helping us make this effort a success. Together, we can work toward change for everyone affected by the potential adverse effects of antidepressants.

👥 Who Should Report SSRI or SNRI Withdrawal to the FDA’s MedWatch Program?

We’re asking the following people to report withdrawal experiences from SSRIs or SNRIs:

Patients — anyone who has personally experienced withdrawal symptoms after reducing or stopping an SSRI or SNRI.
Family members — if a loved one died while tapering or in withdrawal (e.g., withdrawal-induced suicide), or if they’re unable to advocate for themselves, you can submit a report on their behalf.
Friends, coaches, and advocates — if someone you know is experiencing severe cognitive impairment or is unable to advocate for themselves due to withdrawal, you can submit a report on their behalf with their consent to help ensure their experience is represented.
Healthcare providers — if they are aware of your SSRI or SNRI withdrawal experience.
- 📢 You’ll need to ask them to report on your behalf (many do not submit reports even though they’re supposed to)

🧠 What to Focus On in Your Report (if applicable):

Akathisia – extreme restlessness, agitation, and a strong compulsion to move
Severity of withdrawal – describe how intense or debilitating the symptoms have been
Protracted withdrawal symptoms – symptoms lasting months or even years after stopping or tapering
Any documented harm – such as abnormal brain scans, cognitive testing, or other medical evidence
Dose and duration – especially if withdrawal symptoms began after a short time on the drug or at a low dose
Challenges tapering – for example, being unable to reduce in small enough increments because available doses are too large

📧 Please forward your confirmation email to [email protected] so we can track the number of submissions.

The MedWatch Report can be accessed below.

🌍 Not in the U.S.? You Can Still Submit a Report to the FDA

You don’t have to live in the United States to submit a report to the FDA about your experience with a medication. Anyone, anywhere in the world can report adverse effects, including withdrawal, using the FDA’s MedWatch reporting system.

⚠️ Important Notes:

The form is relatively easy to complete, with just four main pages (1, 3, 4, 5).
Click “Next” at the bottom of each page to continue.
The final page allows you to review and edit before submitting.
This reporting drive is for SSRI and SNRI antidepressants only — not other medication types. If you’re unsure what class your medication falls into, you can view a full list here.
Fields with a red asterisk (*) are required.
Provide as much factual detail as you can.
The FDA keeps patient identities strictly confidential and protects them by law; reporter information may be shared with the manufacturer for serious cases unless you request otherwise, but it will never be disclosed to the public under the Freedom of Information Act.

✅ What’s Actually Required to Submit a Report

Don’t be intimidated — most fields on the MedWatch form are optional. Here’s what’s actually required to submit a report:

📄 Page 1 — Problem

Describe what happened
Cause of the problem (e.g., “a problem with a product”)

💊 Page 3 — Product

Name(s) of the product as it appears on the box, bottle, or package

🧍 Page 5 — Reporter

Your name (the reporter’s name)

🧾 How to Report SSRI or SNRI Withdrawal to the FDA (MedWatch)

🔷 Step 1: Start the Report

Go to the FDA MedWatch site:
👉 https://www.accessdata.fda.gov/scripts/medwatch/index.cfm
Click Consumer/Patient

🧍 Step 2: About the Problem

What kind of problem was it?
☑️ Check: “Were hurt or had a bad side effect (including new or worsening symptoms)”

Did any of the following happen?
☑️ Select all that apply:

Hospitalization (admitted or stayed longer)
Required help to prevent permanent harm
Disability or health problem
Birth defect
Life-threatening experience
Death (include date of death)
Other serious/important medical incident

Date of occurrence
📅 Use the approximate date you first noticed withdrawal symptoms.

📝 Step 3: Describe What Happened

✍️ Tip: Write this section in a separate document first, then copy/paste into the form (limit: 4,000 characters).

Include:

Name and dose of the SSRI or SNRI
Duration of use
Reason it was prescribed
How you stopped (slow taper, fast taper, cold turkey)
List all withdrawal symptoms
How long the symptoms lasted and whether they’re ongoing
Any ER visits or hospitalizations related to withdrawal
Mention if a death occurred during withdrawal

🛑 Stick to facts. Avoid emotional language — clarity and accuracy are key.

🧪 Step 4: Tests or Medical Evidence

📋 Include any relevant tests or lab work — even normal results help show symptoms weren’t caused by other conditions:

Brain MRI
Lumbar puncture
ENT testing
Routine blood work
Cardiac exams
Cognitive evaluations
X-rays or CT scans

📦 Step 5: Cause of the Problem

☑️ Check: “For a problem with a product”
Do you still have the product? — Select Yes or No

💊 Step 6: Product Information

Under “This report is about”
☑️ Check: “Other”
Then list name of SSRI or SNRI

You may leave “If therapy is ongoing” unchecked or select Yes

Fill in:

Medication name (as it appears on the bottle or packaging)
Maximum dose you took
Frequency (e.g., once daily)
Route: oral
Dates you used the product
Reason for using it
Did the problem stop after reducing or stopping the product? — Select No
Did the problem return after restarting it? — Select No

Optional but helpful:

Expiration date
Lot and NDC numbers (may be on old prescription labels)

📌 If you took more than one SSRI or SNRI, click “Add another product.”

👤 Step 7: About the Patient (Optional)

You may fill in any details about the patient (yourself or someone else), but this is optional.

🧾 Step 8: About the Reporter

Enter your name and contact information.
✅ Check the yellow box if you do not want your identity shared with the manufacturer.
Review your responses on the final screen.
Click Submit to send your report.

📧 Final Step: Let ACE Know & Share Your Story!

Please forward your confirmation email — or a quick note letting us know you submitted a report — to:
📩 [email protected]