Reporting Adverse Events and/or Product Complaints

What are adverse events and product complaints?

An adverse event is any untoward medical occurrence in a patient who has been given a pharmaceutical product that may or may not have been caused by treatment with the product. An adverse event is commonly referred to as a side effect and can be any unfavorable and unintended sign, symptom or disease associated with the use of a product. 

A product complaint is any inquiry or dissatisfaction with the identity, strength, quality or purity of a pharmaceutical product or medical device, including reports of suspected counterfeit/falsified product.

Why report adverse events and product complaints?

By reporting adverse events and product complaints for Vertex products, you help us ensure the quality and safety of medicines for patients. These reports also help us meet our reporting responsibilities to health authorities.

How do I report an adverse event and/or product complaint?

Region

Email

Phone Number

United States

medicalinfo@vrtx.com

877-634-8789

Canada

medicalinfoCA@vrtx.com

877-634-8789

Brazil

medicalinfoLATAM@vrtx.com

0800-047-4048

Latin America (excluding Brazil)

medicalinfoLATAM@vrtx.com

+55 11-4700-2942

Australia

vertexmedicalinfo@vrtx.com

+43 1800-179-987

United Kingdom

vertexmedicalinfo@vrtx.com

+44 2038-718-772

Switzerland

vertexmedicalinfo@vrtx.com

0800-00-0054

Russia

vertexmedicalinfo@vrtx.com 880-055-10402

All other countries

vertexmedicalinfo@vrtx.com

+35 317-617-299

Or refer to Vertex Global Medical Information for local country numbers: www.vertexmedinfo.com

What information should I include when submitting a report?

Please report all safety information even if the details are incomplete:

  • Name of the product including dose, strength, frequency and lot number

  • A description of the product complaint or side effect associated with the product including all symptoms  

  • Your name and contact information (optional)

  • Information about the person who experienced the side effect (e.g., initials, date of birth, gender, etc.)