Statistics are updated quarterly; data are summarized annually.
Mode of Collection:
Voluntary reports by consumers and health care professionals of adverse events related to FDA-approved drug and therapeutic biologic products; mandatory reports of adverse events reported to pharmaceutical manufacturers.
Patient’s age, gender, weight. Data concerning the event: date of event; type of event (product use error, adverse event, etc.); outcome (death, hospitalization, congenital anomaly, etc.); written description of event. Data concerning the product: product name, manufacturer, lot number and other identifying information, dates of use, diagnosis or reason for use. Data about the person filing report: identifying information, type (consumer, health professional).
Reports from consumers, health professionals, and manufacturers can be made by mail, telephone, or on-line. Adverse event reports are entered into the AERS database. Adverse events in AERS are coded to terms in the Medical Dictionary for Regulatory Activities terminology (MedDRA). AERS events are evaluated by clinical reviewers to monitor the safety of products after they are approved by FDA. If a potential safety concern is identified in AERS, further evaluation might include epidemiological studies. Based on an evaluation of the potential safety concern, FDA may take regulatory action(s) to improve product safety and protect the public health, such as updating a product’s labeling information, restricting the use of the drug, communicating new safety information to the public, or, in rare cases, removing a product from the market.
Response Rates and Sample Size:
AERS contains over 4 million reports of adverse events reported between 1969 and the present.
AERS data have limitations. First, there is no certainty that the reported event was actually due to the product. FDA does not require that a causal relationship between a product and event be proven, and reports do not always contain enough detail to properly evaluate an event. Further, FDA does not receive all adverse event reports that occur with a product. Many factors can influence whether or not an event will be reported, such as the time a product has been marketed and publicity about an event. Therefore, AERS cannot be used to calculate the incidence of an adverse event in the U.S. population.