Report Side Effects or Adverse Events

If you are a patient and think you have experienced a side effect/adverse event or unexpected reaction from a Veru Inc. product, please:

Speak to the healthcare professional who prescribed the medicine as soon as you can
Report the side effect/adverse event to Veru Inc. using the form below

If you are a healthcare provider and your patient has experienced an adverse event from a Veru Inc. product, please:

Report the side effect/adverse event to Veru Inc. using the form below

You may also report the side effect/adverse event directly to the FDA by visiting www.FDA.gov/medwatch or calling 1-800-FDA-1088.

ADVERSE EVENT REPORTING FORM

"*" indicates required fields

Country

Type of person reporting*

Name of person reporting*

First Last

Occupation*

Healthcare profession*

Email address*

Phone*

Due to nature of Pharmacovigilance (PV) activities and legal obligations to follow up with adverse event (AE) reporters and/or special situations received by Veru, Veru might require a formal follow up in an effort to obtain additional details to facilitate a thorough case evaluation.

May we follow up with you if we have additional questions related to the reported adverse event(s)?**

Yes

Are you a Veru employee?

Yes

Initials of patient*

Patient gender*

Male

Female

Prefer not to say

Race

Ethnicity

Age (years)*

Is the patient pregnant?

Yes

Product Information

Product name:*

Strength:

Frequency:

Batch/lot number:

Therapy start date:

Therapy stop date:

Dose reduced?

Yes

Is therapy still ongoing?

Yes

Event abated after treatment stopped or dose reduced?

Yes

Event reappeared after therapy reintroduced?

Yes

Side effect/adverse event details:*

Do not use the patient’s name or any personally identifiable information (email, address, phone number).

Outcome of the adverse event:

Recovered

Recovered with treatment

Recovered with lasting effect

Recovering

Not recovered

Death (patient died)

Adverse event start date:

Adverse event stop date:

Did the adverse event result in any of the following?

Hospitalization

Prolongation of existing hospitalization

Life-threatening illness (immediate risk of death from the event)

Disability or permanent damage

Patient died

Congenital anomaly or birth defect

None of the above

Report 2nd adverse event?

Yes

2nd Side effect/adverse event details:*

Do not use the patient’s name or any personally identifiable information (email, address, phone number).

Outcome of the 2nd adverse event:

Recovered

Recovered with treatment

Recovered with lasting effect

Recovering

Not recovered

Death (patient died)

2nd adverse event start date:

2nd adverse event stop date:

Did the 2nd adverse event result in any of the following?

Hospitalization

Prolongation of existing hospitalization

Life-threatening illness (immediate risk of death from the event)

Disability or permanent damage

Patient died

Congenital anomaly or birth defect

None of the above

Report 3rd adverse event?

Yes

3rd Side effect/adverse event details:*

Do not use the patient’s name or any personally identifiable information (email, address, phone number).

Outcome of the 3rd adverse event:

Recovered

Recovered with treatment

Recovered with lasting effect

Recovering

Not recovered

Death (patient died)

3rd adverse event start date:

3rd adverse event stop date:

Did the 3rd adverse event result in any of the following?

Hospitalization

Prolongation of existing hospitalization

Life-threatening illness (immediate risk of death from the event)

Disability or permanent damage

Patient died

Congenital anomaly or birth defect

None of the above

Additional comments:

Relevant lab details:

Medical history:

Concomitant medication:

Consent to the processing of your personal data*

I confirm that the details I have provided are correct

By clicking the “Submit” button, you confirm your consent to the processing of the personal data as provided in the report. Personal data will be used by Veru Inc. and its affiliates solely to meet our obligations, and may be transferred out of your country. For more information on how Veru processes your personal data, including information on your data protection rights, please visit our privacy notice.

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