AERS Adverse Events Reporting System的用法和样例：
- Quarterly reports that list certain drugs that are being evaluated for potential safety issues, based on a review of information in the FDA's Adverse Event Reporting System (AERS);
- If I am a manufacturer, what information must I submit in my individual adverse event reports?
- The most common treatment-related adverse event reported with tadalafil was headache (32% vs 15% with placebo).
- Adverse events reported most frequently were dizziness in 46%, headache in 32%, fatigue in 30%, diplopia in 30%, nausea in 26%, abnormal vision in 21%, and somnolence in 21%.