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Report an Adverse Event

If you experience a side effect, unexpected reaction, or product quality issue, please tell us. We take every report seriously and are required to escalate serious events to the FDA.

🚨 If this is a medical emergency

If you are experiencing a life-threatening reaction, severe symptoms, or any condition that could be immediately dangerous, call 911 or your local emergency number now. Do not wait to report to us or to the FDA first.

Report to ProtocolRX

For non-emergency reports, contact us as soon as possible. Include as much of the following as you can:

  • Your name and order number
  • The product and lot number (printed on the packaging)
  • Date the reaction began and duration
  • Symptoms and severity
  • Any medical attention received
  • Whether you have discontinued the product

Email support@protocolrx.com

We will respond within one business day and, when clinically appropriate, connect you back to the prescribing provider through our telehealth partner.

Report to the FDA

You can also report adverse events directly to the FDA through the MedWatch program. Reporting is voluntary but strongly encouraged for any serious event.

  • Online: FDA MedWatch reporting portal
  • Phone: 1-800-FDA-1088 (1-800-332-1088)
  • Fax: 1-800-FDA-0178
  • Mail: MedWatch, 5600 Fishers Lane, Rockville, MD 20857

Dietary supplement issues can be reported through the FDA’s Safety Reporting Portal.

What we do with reports

  • We log every report in our safety-signal system.
  • We route reports to the dispensing pharmacy and the prescribing provider for clinical review.
  • We escalate serious adverse events to the FDA as required by law.
  • We investigate product-quality complaints with the pharmacy and, where relevant, halt distribution of affected lots.

Compounded medications

Compounded drugs are not FDA-approved and are not evaluated by the FDA for safety, effectiveness, or quality before dispensing. Post-market surveillance depends on reports from patients and providers. Your report genuinely matters — it helps us and the pharmacy identify safety signals that might otherwise go undetected.