FAEMS reports are more commonly filed for which type of effects?

FAEMS reports are more commonly filed for which type of effects?

• A. Mild Adverse
• B. Beneficial Effects
• C. Severe Adverse
• D. No Effects

Answer: (C)

Spontaneous adverse-event reporting systems rely on people to submit reports about problems suspected to be related to a drug. Those reports are more likely when the problem is serious—life-threatening, causes hospitalization, or requires medical intervention—because such events are more noticeable and demand action. That bias means FAERS is enriched for severe adverse effects, while mild or transient symptoms are often under-reported. Beneficial effects aren’t the focus of FAERS, and “no effect” isn’t something that gets filed as an adverse event. So the type of effect most commonly filed is severe adverse effects.

Spontaneous adverse-event reporting systems rely on people to submit reports about problems suspected to be related to a drug. Those reports are more likely when the problem is serious—life-threatening, causes hospitalization, or requires medical intervention—because such events are more noticeable and demand action. That bias means FAERS is enriched for severe adverse effects, while mild or transient symptoms are often under-reported. Beneficial effects aren’t the focus of FAERS, and “no effect” isn’t something that gets filed as an adverse event. So the type of effect most commonly filed is severe adverse effects.