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Evoluciona Pharma

Adverse Event Reporting

Your Safety Matters. We’re Here to Help.

Evoluciona-doctor-investigation

Evoluciona Pharma is committed to maintaining the highest standards of quality, safety, and regulatory compliance. If you experience an unexpected reaction, side effect, or any issue you believe may be related to a medication compounded by Evoluciona Pharma, it is important to report it promptly.

Adverse event reporting helps ensure product quality, supports patient safety, and assists healthcare professionals in monitoring therapy outcomes.

MD Advantage™ Program

What Is an Adverse Event?

An adverse event is any undesirable or unexpected experience associated with the use of a medication. This may include, but is not limited to:

  • Allergic reactions
  • Injection site reactions
  • Unexpected side effects
  • Incorrect dosing outcomes
  • Issues with product appearance, packaging, or labeling
  • Any symptom or medical concern that you or your healthcare provider believes may be related to the medication

For Patients

If you are experiencing a medical emergency, call 911 or seek immediate medical attention.

Evoluciona Pharma cannot provide clinical advice. If you believe you are experiencing an adverse reaction:

  1. Contact your prescribing physician immediately. Your doctor will determine the appropriate medical steps and may submit an adverse event report on your behalf.
  2. Do not stop or modify your medication unless instructed by your healthcare provider.
  3. You or your physician may also report the event directly to Evoluciona Pharma using the form below.

For Physicians & Healthcare Providers

If your patient experiences an adverse reaction or medication concern, please report it using one of the following options:

Online Reporting Form

Submit an Adverse Event Report through our secure form:

    Adverse Event Report Form

    For use by physicians, clinical staff, and authorized reporters.

    1. Reporter Information (Required)






    2. Patient Information (Required — No PHI)

    Use initials only. Do NOT include full name, DOB, address, SSN, or other PHI.





    3. Medication Details (Required)








    4. Description of the Adverse Event (Required)






    5. Contributing Factors (Optional)





    6. Product Quality Concerns (If applicable)




    7. Email Reporting

    If you prefer to submit this report via email, please send the completed form and event details securely to:

    Compliance / Pharmacovigilance Email:

    info@evoluciona.com

    Information to Include in Your Email

    To ensure proper review and investigation, please include:

    • Patient initials only (no PHI)

    • Medication name, strength, and lot number

    • Description of the event or reaction

    • Date of the event and the date medication was started

    • Relevant medical history or concurrent medications

    • Your contact information for any necessary follow-up

    8. Physician / Clinic Follow-Up (Physician Use Only)




    9. Certification and Submission





    I confirm that the information provided is accurate to the best of my knowledge and contains no protected health information (PHI).

    Evoluciona Pharma’s Quality & Compliance Team may contact you for additional details as needed.

    Choose the Partner That Helps You Deliver More. EVOLUCIONA PHARMA

    Product Quality Concerns

    If you notice any issue with the medication itself—such as discoloration, particles, leakage, or compromised packaging—please discontinue use and report it immediately through the same channels above.

    What Happens After You Submit a Report?

    Your report is reviewed by Evoluciona Pharma’s Quality Assurance & Compliance Team. If necessary, the team may:

    • Contact the provider for clarifying information
    • Investigate the reported lot or formulation
    • Document and escalate findings internally
    • Implement corrective or preventive actions as required
    • Report findings to regulatory authorities when appropriate

    Patients will not be contacted directly by Evoluciona Pharma—communication occurs through the prescribing physician to protect patient privacy.

    Additional Reporting Options

    Adverse events may also be reported directly to the U.S. Food & Drug Administration (FDA): MedWatch Online Reporting: https://www.fda.gov/medwatch

    Phone: 1-800-FDA-108

    Your Safety Is Our Priority

    If you have questions about Evoluciona Pharma’s quality or reporting process, please contact our Compliance Team through the Support & Inquiries section.