Adverse Event Reporting

What is a side effect?

A side effect is any unwanted 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. A side effect can therefore be any unfavorable and unintended sign, symptom, or disease associated with the use of the product.

Why report side effects?

By reporting side effects for Novartis products you help us to ensure the safety of our products and our patients. Your information will also enable Novartis to fulfill its reporting responsibilities to health authorities, which requires that we provide information on side effects with our products - even in cases where a relationship between the product and the effect is not established.

If you or the person you are reporting on behalf of are currently suffering from severe side effects you should contact your local doctor or other medical health professional before reporting the side effect.

How to report side effects?

To report the side effects electronically please click below:

Note: Report Adverse events for Novartis Products only. 

Alternatively, if you are unable to report the side effect electronically you can email your local Novartis Drug Safety Responsible person to: [email protected].

When submitting in an e-mail format please provide the following information in your email to ensure it is handled in a manner consistent with the applicable local laws:

• Name of the drug: Description of when the patient started the medication, including dosing strength and frequency (amount and how often, e.g. 40mg twice daily). Any action taken with the medication (e.g. reduced dose, stopped) and impact of that action on the side effect.
• The side effect associated with the drug: Symptom evolution over time. Description of any treatment needed for the side effect. Name of healthcare provider who provided treatment and contact information.
• Your name (optional): Please note that your personal identifying information (e.g. name, email address) will not be shared with the health authorities. Novartis or its agents may contact you for further information about the side effect. If you do not wish to be contacted, you should indicate this in your email.
• Information about the person who experienced the side effect: Any other medical conditions currently ongoing. Medications currently taken (name, dosing strength, frequency, and when medication was started). Gender and age of the person taking medication (optional).