Reporting an Adverse Event
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 unfavourable 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 products.
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 |
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Phone Number |
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Australia |
+61 1800 179 987 |
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New Zealand |
+64 (0)508 553 435 |
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All other countries |
+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:
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Name of the product including dose, strength, frequency and lot number
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A description of the product complaint or side effect associated with the product including all symptoms
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Your name and contact information (optional)
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Information about the person who experienced the side effect (e.g., initials, date of birth, gender, etc.)
Please note that Vertex may process your personal data in accordance with our Privacy policy if you report a side effect or if your treating physician reports a side effect.