Report side effects or adverse events
What is a side effect or adverse event?
A side effect or adverse event is any unwanted medical occurrence in a patient who has been given a Novartis product that may or may not have been caused by treatment with the product. A side effect or adverse event can therefore be any unfavorable and unintended sign, symptom, or disease associated with the use of the product.
*Includes administration (at any dose) of drug, biologic, gene therapy, theragnostic product, drug-device combination product, or medical device
Why report side effects or adverse events?
By reporting side effects or adverse events 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 or adverse events with our products - even in cases where a relationship between the product and the effect is not established.
Pregnancy is a special case of an adverse event. Report any use of Novartis products during pregnancy to ensure safety for the mother and baby. In addition to pregnancy and lactation, there are other special situations that need to be reported as adverse events. These include lab abnormalities, overdoses, off-label use, misuse, abuse, occupational exposure, medication errors, lack of efficacy, drug interactions, infectious disease transmission, withdrawal, and rebound effects.
If you or the person you are reporting on behalf of are currently suffering from severe side effects or adverse events you should contact your local doctor or other medical health professional before reporting the side effect or adverse event.
How to report side effects or adverse events?
To report the side effects or adverse events electronically please click below:
Report a side effect or adverse event
Note: Report side effects or adverse events for Novartis Products only.
Alternatively, if you are unable to report the side effect or adverse event electronically you can email your local Novartis Drug Safety Responsible person (Scroll below for the contact details).
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 Novartis product:
- Description of when the patient started the treatment, including dosing strength and frequency (amount and how often, e.g. 40mg twice daily). Any action taken with the product (e.g. reduced dose, discontinued) and impact of that action on the side effect or adverse event.
- The side effect or adverse event associated with the product:
- Symptom evolution over time. Description of any treatment needed for the side effect or adverse event. 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 or adverse event. If you do not wish to be contacted, you should indicate this in your email.
- Information about the person who experienced the side effect or adverse event:
- 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).