You can report PSSD to the FDA using this link.

1. Open the FDA MedWatch portal and choose “Consumer/Patient (FDA Form 3500B)” under Begin Online Report.

2. Section A – About the Problem.

   • A1–A3: Indicate you were hurt or had a bad side effect and give the date the problem occurred.

   • A4: In the free-text narrative, state “Post selective serotonin re-uptake inhibitor sexual dysfunction (PSSD)” and include MedDRA code 10086208.
     Describe symptoms, onset during or after SSRI/SNRI use, and persistence after discontinuation.

   • A5: Add relevant tests or “None.”

3. Section B – Product Availability. Indicate if you still have the product and whether you can upload a photo of the prescription label or bottle.

4. Section C – About the Products (Drug/medicine). Enter suspect antidepressant details: product name (generic and brand), manufacturer if known, OTC or Rx, NDC if available, strength, dose, frequency, route, start and stop dates, reason prescribed, and whether symptoms improved on stopping or returned on restart. Add additional antidepressants if applicable.

5. Skip Section D (Medical Device) unless relevant.

6. Section E – About the Person Who Had the Problem. Provide age, sex at birth, weight, relevant conditions, allergies, and all other medications or supplements currently used.

7. Section F – About You (the Reporter). Provide your contact information. If you do not want your identity disclosed to the manufacturer, check the box in F11.

8. Review and submit the report online. Alternatively, download Form FDA 3500B and mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852, or fax to 800-332-0178.

Your report to the FDA is now complete.

You can report PSSD in the UK using this link.

Step 1. Go to the Yellow Card portal and click “Report a suspected problem or side effect”.

Step 2. Select the report type: choose “Side effect” (adverse drug reaction).

Step 3. Provide details of the person affected: age, sex, weight, medical conditions, allergies, and other medicines or supplements currently being used.

Step 4. Enter medicine details:

• Medicine name (generic and brand, e.g., sertraline / Zoloft).

• Strength, dosage, frequency, and route (oral, daily, etc.).

• Start and stop dates.

• Reason it was prescribed (e.g., depression, anxiety).

• Manufacturer and batch/lot number if known (optional).

Step 5. Describe the problem:

• Use the term “Post selective serotonin re-uptake inhibitor sexual dysfunction (PSSD)”.

• Include the MedDRA code 10086208 in your description.

• List specific symptoms: e.g., genital anesthesia, erectile dysfunction, anorgasmia, loss of libido, emotional blunting, etc.

• State when symptoms started (during treatment, after discontinuation).

• Clarify that the symptoms persisted after stopping the drug and for how long.

• Add information about improvement or lack of improvement after stopping, and whether any rechallenge occurred.

• Describe the impact on quality of life (sexual, psychological, daily functioning).

Step 6. Add supporting information:

• Any tests, investigations, or consultations done.

• Upload documents if available (optional).

Step 7. Provide your details:

• Your contact information (to allow MHRA to follow up if needed).

• Indicate if you are the patient, a relative, or a healthcare professional.

Step 8. Review and submit the report. You’ll receive a confirmation reference number for your submission.

Your report to the UK MHRA is now done.

RxISK collects patient reports to capture drug harms clinical trials and national pharmacovigilance failed to identify. Reports to Rxisk have led to scientific literature on PSSD.

1. Go to rxisk.org/experiencing-a-drug-side-effect/ and click “Complete a RxISK Report.”

2. Enter your email (required) so you receive a copy. Optionally add demographics like age, sex, country, weight. Add medical history and current medications or supplements.

3. Provide suspect drug details: name (generic and brand), dose, frequency, route, start and stop dates, and any dose changes.

4. Describe the side effect: write “Post selective serotonin re-uptake inhibitor sexual dysfunction (PSSD)” and include SNOMED CT code 1340196008. List symptoms such as genital numbness, erectile dysfunction, loss of libido, anorgasmia, emotional blunting, etc. Indicate onset (during treatment or after stopping), persistence after discontinuation, duration, and whether there was improvement or not.

5. Complete the causality questions: RxISK asks about timing, alternative causes, dechallenge/rechallenge, and other structured items to calculate the RxISK Score.

6. Review and submit the report. You will get a PDF copy with all details and a calculated RxISK Score. You can share this PDF with your doctor or pharmacist.

7. Optionally, invite your healthcare provider to add comments via the “HCP Comment” link.

What to include for best quality report: detailed drug information, detailed symptoms, exact timing, persistence after stopping, attempts to reverse the problem, and the SNOMED CT code 1340196008 so the condition is clearly identified.