Table 1.
Product–event pairs selected for analysis
| Drug | Adverse event | Month identified | |
|---|---|---|---|
| 1 | Lisdexamfetamine | Raynaud’s phenomenon | Mar 2011 |
| 2 | Olmesartan | Sprue-like enteropathy | Sep 2011 |
| 3 | Methylphenidate | Priapism | Sep 2011 |
| 4 | Topical econazole | Increased international normalized ratio (INR) | Feb 2012 |
| 5 | Pradaxa | Angioedema | Apr 2012 |
| 6 | Dronedarone | Vasculitis | Apr 2012 |
| 7 | Hydroxyzine | Serious injection site reactions | Jul 2012 |
| 8 | Ziprasidone | Drug reaction with eosinophilia and systemic symptoms (DRESS) | Jun 2014 |
| 9 | Tecfidera | Progressive multifocal leukoencephalopathy (PML) | Oct 2014 |
| 10 | Banana Boat Sunscreen Spray | Flammablility resulting in serious skin burns | Jun 2012 |