Suspected Adverse Reaction Form Food and Drug Administration
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People also ask
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What to do if patient has an adverse reaction to a drug?
If the ADR is serious, stay with the patient and have a colleague notify the prescriber. Document the patient's clinical condition, your interventions, and the patient's response. When the patient is stable, inform your supervisor, pharmacist, and risk manager if the ADR was serious. -
What is an example of adverse drug reaction form?
Examples of such adverse drug reactions include rashes, jaundice, anemia, a decrease in the white blood cell count, kidney damage, and nerve injury that may impair vision or hearing. These reactions tend to be more serious but typically occur in a very small number of people. -
What does suspected adverse drug reaction mean?
Suspected adverse reaction means any adverse event for which there is a reasonable possibility that the drug caused the adverse event. For the purposes of IND safety reporting, "reasonable possibility" means there is evidence to suggest a causal relationship between the drug and the adverse event. -
How can suspected adverse drug reactions be reported to the FDA?
Call FDA at 1-800-FDA-1088 to report by telephone. Reporting Form FDA 3500 commonly used by health professionals.
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