Idorsia Adverse Event Reporting Form

We strongly encourage you to report any possible ADVERSE EVENT OR SIDE EFFECT due to one of our products. Please report your ADVERSE EVENT OR SIDE EFFECT using the following form.

If this is an emergency, please contact your local health care physician immediately.

Adverse Event/Side Effect Information:

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Country of Occurrence

Description of side effect (including outcome/result of side effect, relevant medical history and any other relevant details)

Describe the adverse event/side effect providing details on treatment needed and medical history, if any.

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Start Date of Reaction/Event

The date of the start of the reaction/event or date of the first symptom.

End Date of Reaction/Event

The date the reaction/event was reported as resolved/recovered

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Life Threatening

Life Threatening

Congenital Anomaly/Birth Defect

Congenital Anomaly/Birth Defect

Results in Death

Results in Death

Disabling/Incapacitating

Disabling/Incapacitating

Other Medically Important Condition

Other Medically Important Condition

Caused/Prolonged Hospitalization

Caused/Prolonged Hospitalization

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Date of Death

Outcome at Last Observation

Please provide the latest outcome of the adverse event or side effect you experienced.

Date of Hospitalization

Patient Information:

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Patient Name/Initials

The identification of the patient may be prohibited by certain national confidentiality laws or directives. The information should be provided when it is in conformance with the confidentiality requirements

Patient Gender

The sex of the patient

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Patient Age

The age at the time of the first reaction/event (number only)

Patient DOB

A full precision date should be used (i.e., day, month, year). If the full date of birth is unknown, an approximate age can be used

Patient Age Unit

When providing the age in decades,please note that, for example, the 7th decade refers to a person in their 60’s

Product Information:

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Select the reported product

Batch/Lot Number

This is particularly important for vaccines and biologicals. The section allows for multiple batch or lot numbers, each separated by a delimiter defined by the transmission standard chosen. The most specific information available should be provided.

Dosage Information

Example: 5 mg 2 times a day every other day for 30 days

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Start of Drug

First date of use

Date of Last Administration

For ongoing drug administration after the onset of the reaction or event, this item should be blank and Actions taken with drug should be used.

Action taken with Drug as a Result of Side Effect

These data, taken together with the outcome of the reaction, provide the information concerning dechallenge. "Not applicable" should be used in circumstances such as if the patient died or the treatment had been completed prior to the reaction or event.

Reporter Information

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Consent to Contact?

Captures whether the reporter has consented to being contacted in relation to this report.

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Reporter Title

Reporter First Name

Reporter Last Name

Reporter City

Reporter Postal Code

Reporter Email

Reporter Organization

Reporter Qualification

Reporter Street Address

Reporter State

Reporter Country

Reporter Phone

* I understand this form is not for reporting potential product quality complaints. To report suspected product quality complaints online, click here

Idorsia retains your personal data to address or provide a reply to your medical information inquiry. In processing your personal data, Idorsia will fully comply with internationally recognized standards of data protection. In doing so, Idorsia ensures compliance of its staff with strict standards of security and confidentiality. Additional information on the processing of personal data and the exercise of rights related to your personal data can be found in Idorsia’s Privacy Policy