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Report an Adverse Event or Product Quality Complaint

Live assistance is available Monday – Friday, between the hours of 9 AM and 7 PM EST.

1 (888) 661-9260

Your support is critical to Chiesi USA for providing up-to-date safety and quality information about our products. Collecting information about side effects and adverse events enables us to continually monitor the benefit and risk profiles of our products. Reporting of product complaints allows us to monitor the quality of the product and evaluate for any needed improvements.

An adverse event is any unwanted or undesirable 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. An adverse even can therefore be any unfavorable and unintended sign, symptom or disease associated with the use of the product.


To help us process your information quickly and effectively, please report as much relevant information as possible. At a minimum, you should provide the following:

  1. The initials of the person who experienced the adverse event an/or other identifiers such as gender, date of birth
  2. The contact information of the person reporting the issue
  3. A description of the adverse event, such as signs and symptoms experienced, date the event started, result of the event
  4. The name of the Chiesi product

Chiesi USA is required by law to investigate safety events and may be obliged to report such incidents to the Food and Drug Administration (FDA). Accordingly, Chiesi USA will collect the information provided by you as the reporter, and may use this information to contact you and seek additional details as required to fulfill our regulatory obligations.

Personal information you provide is collected and shared as required to comply with the law and to facilitate your request. If the information is collected on behalf of Chiesi, it will be processed in accordance with the law and Chiesi’s Privacy Policy.

Adverse events may also be reported to the FDA’s MedWatch Program at or by calling (800) FDA-1088