TABLE 1.
COVID-19 cases from FAERS reports, US only, overall and by treatment group. COVID-19 cases are all cases reported to FAERS with a COVID-19 related term in Reactions. Treatment groups are monotherapy only except for glucocorticoids, but within-group combinations (e.g., Ocrelizumab + Rituximab) are included. Cases with COVID-19 as only indication are excluded from the treatment group data sets. Data from 2020–01–22 to 2022–06–30, US. Cases are counted as died if death was reported in the outcomes list, and as survived otherwise. The lines printed in bold are group totals/group headers. Note that since within-group combinations are allowed, the sum over all cases for all individual treatments within a treatment group may be greater than the total number of cases for the entire treatment group. Abbreviations: IQR: Interquartile range, the 25th and 75th percentile; COVID-19: Corona Virus Disease-2019; FAERS: FDA Adverse Event Reporting System.
| Overall | Died | Survived | |
|---|---|---|---|
| Whole dataset: All COVID-19 cases in FAERS, US | 49,742 | 3756 | 45,986 |
| Sex (n, %) | |||
| Female | 28,587 (57.47) | 1434 (38.18) | 27,153 (59.05) |
| Male | 17,421 (35.02) | 1897 (50.51) | 15,524 (33.76) |
| Not specified | 3734 (7.51) | 425 (11.32) | 3309 (7.20) |
| Age (Median, IQR) | |||
| Overall | 59 (47–69) | 70 (60–78) | 58 (46–67) |
| Female | 58 (46–67) | 68 (60–78) | 57 (46–67) |
| Male | 61 (48–70) | 70 (62–78) | 59 (46–69) |
| Not specified | 62 (45–70) | 65 (54–71) | 60 (44–69) |
| Treatment subgroups: COVID-19 cases in FAERS, US, by treatment | |||
| Anti-CD20, monotherapy | 1907 | 202 | 1705 |
| Ocrelizumab | 1142 | 91 | 1051 |
| Ofatumumab | 459 | 8 | 451 |
| Rituximab | 320 | 104 | 216 |
| Anti-TNFα, monotherapy | 3189 | 98 | 3091 |
| Adalimumab | 1807 | 65 | 1742 |
| Certolizumab Pegol | 625 | 12 | 613 |
| Etanercept | 597 | 11 | 586 |
| Golimumab | 78 | 1 | 77 |
| Infliximab | 96 | 9 | 87 |
| Glucocorticoids | 1176 | 208 | 968 |
| Betamethasone | 8 | 0 | 8 |
| Cortisone | 1 | 0 | 1 |
| Dexamethasone | 186 | 57 | 129 |
| Dexamethasone Sodium Phosphate | 7 | 5 | 2 |
| Methylprednisolone | 76 | 12 | 64 |
| Methylprednisolone Sodium Succinate | 15 | 9 | 6 |
| Prednisolone | 158 | 25 | 133 |
| Prednisone | 811 | 131 | 680 |
| JAK inhibitors, monotherapy | 3572 | 183 | 3389 |
| Baricitinib | 53 | 16 | 37 |
| Ruxolitinib | 396 | 64 | 332 |
| Tofacitinib Citrate | 2439 | 56 | 2383 |
| Upadacitinib | 686 | 47 | 639 |
| Thalidomide analogs, monotherapy | 4307 | 424 | 1835 |
| Lenalidomide | 3350 | 337 | 3013 |
| Pomalidomide | 934 | 80 | 854 |
| Thalidomide | 54 | 13 | 41 |