An adverse drug reaction is a reaction that is noxious and unintended, and which occurs at doses normally used for the prophylaxis, diagnosis or therapy of disease, or for the modification of physiological function.
Adverse drug reactions are for the most part only suspected associations.  Reports should be submitted on:
1.    Any serious adverse event that might be associated with a drug, biologic, medical device, or dietary supplement. 
2.    Unexpected events not consistent with the product information or labeling regardless of their severity.
3.    Therapeutic failures – cases where the drug or device failed to work as it should
4.    Case of use errors with medications or devices where the error may have been due to: poor communication, ambiguities in product names, directions for use or packaging
5.    Product quality issues: suspected counterfeit products, defective components, potential contamination, device malfunctions, poor packaging.

Adverse drug reactions should be reported as soon as it is suspected that drug therapy has resulted in a negative, unintended effect.

Submit an adverse drug reaction report here

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Download the SVG Suspected Adverse Drug Reaction Report Form here