Table 3.
Off-Label Drug Classifications for Reported Adverse Events in the FAERS Data
| Drug Classification | 2014 (N=295556) | 2015 (N=574499) | 2016 (N=709274) | 2017 (N=1026588) | 2018 (N=1042836) |
|---|---|---|---|---|---|
| Antithrombotic agents | 18,315 (6.20) | 36,033 (6.27) | 50,899 (7.18) | 66,460 (6.47) | 62,901 (6.03) |
| Immunosuppressants | 11,700 (3.96) | 20,876 (3.63) | 27,833 (3.92) | 81,944 (7.98) | 49,680 (4.76) |
| Drugs for peptic ulcer and gastro-oesophageal reflux disease | 11,004 (3.72) | 23,705 (4.13) | 29,663 (4.18) | 35,153 (3.42) | 69,766 (6.69) |
| Antidepressants | 13,138 (4.45) | 25,212 (4.39) | 30,028 (4.23) | 40,596 (3.95) | 42,412 (4.07) |
| Opioids | 13,543 (4.58) | 22,773 (3.96) | 24,895 (3.51) | 35,922 (3.50) | 40,086 (3.84) |
| Antiepileptics | 11,343 (3.84) | 20,513 (3.57) | 24,911(3.51) | 36,384 (3.55) | 35,708 (3.42) |
| Lipid modifying agents, plain | 8912 (3.02) | 19,429 (3.38) | 25,389 (3.58) | 30,908 (3.01) | 35,723 (3.43) |
| Antipsychotics | 7548 (2.55) | 13,737 (2.39) | 15,886 (2.24) | 33,627 (3.28) | 27,317 (2.62) |
| First-generation | 2007 (0.68) | 3731 (0.65) | 4049 (0.57) | 6791 (0.66) | 7112 (0.68) |
| Second-generation | 5541 (1.87) | 10,006 (1.74) | 11,837 (1.67) | 26,836 (2.61) | 20,205 (1.94) |
| Antineoplastic agents | 9372 (3.17) | 16,511 (2.87) | 18,634 (2.63) | 46,176 (4.50) | 30,173 (2.90) |
| Chemotherapy | 4712 (1.59) | 7415 (1.29) | 6830 (0.96) | 16,776 (1.63) | 12,036 (1.16) |
| Targeted therapy | 4660 (1.58) | 9096 (1.58) | 11,804 (1.66) | 29,400 (2.86) | 18,137 (1.74) |
| Anxiolytics | 7968 (2.70) | 13,246 (4.48) | 14,402 (2.03) | 19,534 (1.90) | 22,351 (2.14) |
| Direct acting antivirals | 4368 (1.48) | 11,157 (1.94) | 11,323 (1.60) | 15,054 (1.47) | 13,263 (1.27) |
Note: Values are reported as n (%).
Abbreviation: FAERS, Food and Drug Administration Adverse Event Reporting System.