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Report a potential side effect

When a patient experiences something unexpected, harmful or negative while taking a Genentech medicine, this is called a side effect (also sometimes referred to as an Adverse Event).

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

Examples of potential side effects / adverse events include:

  • Headache
  • Nausea (feeling sick)
  • Vomiting
Even if you don't know what caused the potential side effect or if you suspect that it was not caused by the medicine, the potential side effect still needs to be reported.

Scenario: Potential Side Effect

Miguel is attending a regional medical conference. One of the speakers at the conference is a patient who is receiving a Genentech medicine for her condition. During the presentation, the patient tells the audience that when she first started taking the medicine she experienced frequent headaches. Because of this, her doctor reduced his dosage and after that, her headaches went away.


Miguel must report this potential side effect because the new information may impact the safety profile of the medicine.

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Product Details

An Adverse Event (AE), also known as a side effect, is an unwanted and unintended response in a patient, after receiving a medicinal product, that may or may not have been caused by treatment with this product. This includes all events where harm or unintended and unwanted response in a patient, user or other person as a result of the use of a medical device. The information you provide helps to ensure the safety of our products and our patients.

For which Genentech product do you want to report a potential side effect?

Could you please submit additional product details?

Please submit as many product details as possible, including the reason for taking the product.

Side effect details

Side effect examples

Side effects may include (but are not limited to) symptoms like:

  • Nausea (feeling sick)
  • Headache
  • Itching
  • Vomiting

Side effect description

Please describe the adverse event as accurate as possible and provide as many details as possible, like for example: The [side effect] occured after taking [the product] on [date]. The [side effect] started on [date] and the patient was admitted into hospital. The [side effect] stopped on [date].

Pregnancy-related details

The pregnancy-related questions are meant to collect information about side effects and pregnancy. Thank you for contributing to making our products safer and more efficient.

Describe here the side effect, if this has resolved or is ongoing, how serious this is/was, the outcome and any further information that may be relevant both before, during and after the side effect occurred. For medical devices please also describe the way the device caused or contributed to the event and if relevant clearly describe the device malfunction causing the event.

Please give the specific symptoms experienced and then provide a description of the events:

Pregnancy-related details (optional)

Information about the use of our medicines during pregnancy is valuable to us to increase knowledge of their safety and inform patients. Please note, patients should consult with their healthcare professional to be informed on the safety of taking a medicine during pregnancy.

Was a pregnancy/breastfeeding taking place at the same time as either the side effect was experienced, or the Genentech product was consumed?

Information about the patient

To improve the safety of our medication, any information (at least 1 identifying detail) you can provide is very helpful. The data will be stored in accordance with data privacy regulations.

Gender

Reporter details

Are you a…
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Can we contact your healthcare professional?
Healthcare professional contact details

If you consent in contacting your healthcare professional, please provide details below.


By checking the box, you consent to our processing of your personal information, and/or another patient's personal information (if you are reporting on behalf of the patient), information about our products that you or your patient used, and any other information pertaining to the product complaint and Adverse Events you or your patient experienced as described in Genentech’s Privacy Policy. We will process this information to respond to you or your patient’s inquiry, for regulatory purposes and for our internal business and legal purposes. We will not sell this information nor will we share it for purposes of targeted advertising.

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