What is an adverse event?

Any untoward medical occurrence in a patient or clinical-trial subject administered a medicinal product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign (e.g. an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether considered related to the medicinal product.

Why report adverse events?

Novartis takes pride in the continued efforts to ensure the safety of our patients while on our products. By reporting adverse events for Novartis products you can help us achieve this. Your information will also enable Novartis to fulfill its reporting responsibilities to health authorities, which requires that we provide information on adverse events with our products, even in cases where a relationship between the product and the effect is not established.

This video demonstrates how a reported adverse event contributes to better understanding of the safety profile of a drug.

For Adverse Events Reporting, visit https://www.report.novartis.com or email: [email protected]