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Safety

Report an Adverse Event

If something happened that you think may be related to your medication, we want to know — whether or not you are sure it was the medication.

Effective: August 18, 2026 Last reviewed: August 18, 2026

In plain language

If this is an emergency, stop reading and call 911. For thoughts of self-harm, call or text 988.

For anything else, report it by secure message, phone, or email. Reporting is free, takes a few minutes, and does not affect your billing or your care.

You can also report directly to the FDA, and you can do that anonymously if you prefer.

01If this is an emergency

Do not use this page to report an emergency. Secure messages and email are not monitored continuously and may not be read for one or more business days.

Call 911 or go to the nearest emergency department for severe abdominal pain that will not go away, swelling of the face, lips, tongue, or throat, difficulty breathing, chest pain, or persistent vomiting with signs of dehydration.
Call or text 988 for the Suicide & Crisis Lifeline if you are having thoughts of self-harm.
Call 1-800-222-1222 for Poison Control.

Once you are safe, please tell us what happened so it can be documented in your record and reported appropriately.

02What to report

Report anything that seems wrong. You do not need to be certain the medication caused it — determining that is our job, not yours.

Adverse events

  • Any side effect, including common ones like nausea, that is severe, persistent, or worse than expected;
  • Any hospitalization, emergency visit, or new diagnosis while on treatment;
  • An allergic reaction of any severity;
  • Symptoms listed as serious in the Important Safety Information;
  • A pregnancy that occurs while on treatment;
  • Depression, mood change, or thoughts of self-harm;
  • An accidental overdose, a missed or doubled dose with consequences, or an injection error.

Product quality problems

  • Medication that is cloudy, discolored, or contains visible particles;
  • Packaging that arrived damaged, leaking, or unsealed;
  • A shipment that arrived warm, or with fully melted refrigerant;
  • A label that is wrong, unreadable, or does not match what you were prescribed;
  • A device or pen that malfunctioned;
  • Medication that appears to have no effect, or a markedly different effect than previous supply of the same product.

Do not use a product you are concerned about. Keep it, keep the packaging, and photograph both.

03How to report to us

RTN Rx Safety Team

Secure message — sign in and message your care team; this reaches a clinician fastest
Phone — 1-833-995-7240, Mon–Fri 8am–8pm ET · Sat 9am–5pm ET
Email — info@rtnrx.com
Mail — Safety Team, Routine RX LLC, P.O. Box 8130, Fayetteville, AR 72717

What to include

  • Your name and date of birth;
  • The medication, dose, and how long you have been taking it;
  • What happened, when it started, and how long it lasted;
  • Whether you stopped the medication, and whether the problem improved;
  • Any treatment you received, including emergency care;
  • Other medications, supplements, and relevant medical history;
  • The pharmacy name and lot number from the label, and photographs, for a product quality problem.

Partial information is still useful. Send what you have.

04What we do with your report

  1. Clinical triage. A clinician reviews every report. Reports describing a serious event are reviewed the same business day, and we will contact you.
  2. Your care. Your clinician will advise whether to stop, hold, or adjust your medication, and will document the event in your medical record.
  3. Reporting onward. We report serious and unexpected adverse events to the FDA through MedWatch, and to the manufacturer or compounding pharmacy as applicable. Product quality complaints go to the dispensing pharmacy and, where warranted, to the FDA and the state board of pharmacy.
  4. Replacement. If a product quality problem is confirmed, the pharmacy replaces the medication at no cost to you.
  5. Follow-up. We may contact you for additional detail. You are never obliged to respond.

Reports we submit to the FDA include the clinical details necessary to evaluate the event. Your identity is protected in accordance with the Notice of Privacy Practices and applicable law.

05Reporting directly to the FDA

You have the right to report directly to the FDA, in addition to or instead of telling us. You do not need our permission, and you may report anonymously.

FDA MedWatch

Online — fda.gov/medwatch
Phone — 1-800-FDA-1088 (1-800-332-1088)
Fax — 1-800-FDA-0178
Mail — MedWatch, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20852-9787

You may also report a compounding pharmacy to your state board of pharmacy, and a clinician to your state medical board. Your care team will give you those contact details on request without asking why.

06No cost, no retaliation

Reporting is free. It will never affect your pricing, your access to care, or your standing with your clinician, and we will not discourage you from reporting to a regulator. If you feel a report was not taken seriously, escalate it to info@rtnrx.com with the words "escalation" in the subject line and a clinical lead will review it.