TABLE 1.
Clinical characteristics of reports with ciprofloxacin-, levofloxacin-, and moxifloxacin-associated tendonitis and tendon rupture from the FAERS database (January 2016 to March 2021).
| Characteristic | Ciprofloxacin (N, %) | Levofloxacin (N, %) | Moxifloxacin (N, %) | All fluoroquinolones | ||||
|---|---|---|---|---|---|---|---|---|
| Tendonitis | Tendon rupture | Tendonitis | Tendon rupture | Tendonitis | Tendon rupture | Tendonitis | Tendon rupture | |
| Number of events of tendonitis or tendon rupture | 905 | 449 | 798 | 536 | 68 | 33 | 1771 | 1018 |
| Gender | ||||||||
| Female | 482 (53.26) | 225 (50.11) | 438 (54.89) | 241 (44.96) | 33 (48.53) | 17 (51.52) | 953 (53.81) | 483 (47.45) |
| Male | 380 (41.99) | 203 (45.21) | 248 (31.08) | 240 (44.78) | 30 (44.12) | 15 (45.45) | 658 (37.15) | 458 (44.99) |
| Unknown | 43 (4.75) | 21 (4.68) | 112 (14.04) | 55 (10.26) | 5 (7.35) | 1 (3.03) | 160 (9.03) | 77 (7.56) |
| Age (year) | ||||||||
| <18 | 11 (1.22) | 0 (0.00) | 8 (1.00) | 8 (1.49) | 0 (0.00) | 0 (0.00) | 19 (1.07) | 8 (0.78) |
| 18≤ and ≤65 | 635 (70.16) | 229 (51.00) | 386 (48.37) | 196 (36.57) | 43 (63.24) | 18 (54.54) | 1064 (60.08) | 443 (43.52) |
| >65 | 138 (15.25) | 135 (30.07) | 206 (25.81) | 213 (39.74) | 11 (16.18) | 10 (30.30) | 355 (20.05) | 358 (35.17) |
| Unknown | 121 (13.37) | 85 (18.93) | 198 (24.94) | 119 (22.20) | 14 (20.59) | 5 (15.15) | 333 (18.80) | 209 (20.53) |
| Mean age (year) | 49.88 | 58.19 | 57.71 | 63.78 | 52.44 | 60.43 | 53.24 | 61.15 |
| Indications | ||||||||
| Infections | 724 (80.00) | 321 (71.49) | 599 (75.06) | 377 (70.34) | 48 (70.59) | 23 (69.70) | 1371 (77.41) | 721 (70.83) |
| Others | 79 (8.73) | 32 (7.13) | 84 (10.53) | 73 (13.62) | 13 (19.12) | 5 (15.15) | 176 (9.94) | 110 (10.81) |
| Product used for unknown indication | 72 (7.96) | 76 (16.93) | 121 (15.16) | 87 (16.23) | 4 (5.88) | 2 (6.06) | 197 (11.12) | 165 (16.21) |
| Serious outcome | ||||||||
| Death (DE) | 2 (0.22) | 1 (0.22) | 1 (0.12) | 4 (0.75) | 1 (1.47) | 0 (0.00) | 4 (0.23) | 5 (0.49) |
| Life-threatening (LT) | 15 (1.66) | 16 (3.56) | 9 (1.13) | 11 (2.05) | 4 (5.88) | 0 (0.00) | 28 (1.58) | 27 (2.65) |
| Hospitalization—initial or prolonged (HO) | 150 (16.57) | 126 (28.06) | 100 (12.53) | 149 (27.80) | 9 (13.24) | 14 (42.42) | 259 (14.62) | 289 (28.39) |
| Disability (DS) | 461 (50.94) | 186 (41.42) | 360 (45.11) | 219 (40.86) | 20 (29.41) | 10 (30.30) | 841 (47.49) | 415 (40.77) |
| Congenital anomaly (CA) | 1 (0.11) | 0 (0.00) | 0 (0.00) | 0 (0.00) | 0 (0.00) | 0 (0.00) | 1 (0.06) | 0 (0.00) |
| Required intervention to prevent permanent impairment/damage (RI) | 4 (0.44) | 5 (1.11) | 13 (1.63) | 11 (2.05) | 0 (0.00) | 0 (0.00) | 17 (0.96) | 16 (1.57) |
| Other serious (important medical event) (OT) | 524 (57.90) | 280 (62.36) | 400 (50.12) | 287 (53.54) | 44 (64.70) | 15 (45.45) | 968 (54.66) | 582 (57.17) |
| Reporting region | ||||||||
| Africa | 0 (0.00) | 0 (0.00) | 3 (0.38) | 2 (0.37) | 0 (0.00) | 0 (0.00) | 3 (0.17) | 2 (0.20) |
| Asia | 2 (0.22) | 2 (0.44) | 12 (1.50) | 10 (1.86) | 4 (5.88) | 1 (3.03) | 18 (1.02) | 13 (1.28) |
| Europe | 497 (54.92) | 193 (42.98) | 314 (39.35) | 162 (30.22) | 21 (30.88) | 10 (30.30) | 832 (46.98) | 365 (35.85) |
| North America | 398 (43.98) | 249 (55.46) | 457 (57.27) | 358 (66.79) | 43 (63.24) | 22 (66.67) | 898 (50.71) | 629 (61.79) |
| Oceania | 2 (0.22) | 0 (0.00) | 1 (0.12) | 1 (0.19) | 0 (0.00) | 0 (0.00) | 3 (0.17) | 1 (0.10) |
| South America | 0 (0.00) | 1 (0.22) | 1 (0.12) | 0 (0.00) | 0 (0.00) | 0 (0.00) | 1 (0.06) | 1 (0.10) |
| Unknown | 6 (0.66) | 0 (0.00) | 10 (1.25) | 3 (0.56) | 0 (0.00) | 0 (0.00) | 16 (0.90) | 3 (0.29) |
| Reported person | ||||||||
| Health professional | ||||||||
| Physician (MD) | 98 (10.83) | 57 (12.69) | 103 (12.91) | 67 (12.50) | 11 (16.18) | 7 (21.21) | 212 (11.97) | 131 (12.87) |
| Pharmacist (PH) | 33 (3.65) | 11 (2.45) | 30 (3.76) | 40 (7.46) | 2 (2.94) | 0 (0.00) | 65 (3.67) | 51 (5.01) |
| Health professional (HP) | 84 (9.28) | 19 (4.23) | 37 (4.64) | 23 (4.29) | 3 (4.41) | 1 (3.03) | 124 (7.00) | 43 (4.22) |
| Other health professional (OT) | 129 (14.25) | 77 (17.15) | 98 (12.28) | 62 (11.57) | 13 (19.12) | 9 (27.27) | 240 (13.55) | 148 (14.54) |
| Non-healthcare professional | ||||||||
| Consumer (CN) | 516 (57.02) | 252 (56.12) | 459 (57.52) | 298 (55.60) | 33 (48.53) | 13 (39.39) | 1008 (56.92) | 563 (55.30) |
| Lawyer (LW) | 1 (0.11) | 7 (1.56) | 0 (0.00) | 2 (0.37) | 2 (2.94) | 0 (0.00) | 3 (0.17) | 9 (0.88) |
| Unknown | 44 (4.86) | 26 (5.79) | 71 (8.90) | 44 (8.21) | 4 (5.88) | 3 (9.09) | 119 (6.72) | 73 (7.17) |
| Reporting year | ||||||||
| 2021 Q1 a | 40 (4.42) | 11 (2.45) | 19 (2.38) | 12 (2.24) | 0 (0.00) | 0 (0.00) | 59 (3.33) | 23 (2.26) |
| 2020 | 178 (19.67) | 49 (10.91) | 123 (15.41) | 79 (14.74) | 11 (16.18) | 4 (12.12) | 312 (17.62) | 132 (12.97) |
| 2019 | 189 (20.88) | 107 (23.83) | 145 (18.17) | 84 (15.67) | 12 (17.64) | 9 (27.27) | 346 (19.54) | 200 (19.65) |
| 2018 | 214 (23.65) | 108 (24.05) | 178 (22.30) | 121 (22.57) | 12 (17.64) | 2 (6.06) | 404 (22.81) | 231 (22.69) |
| 2017 | 121 (13.37) | 79 (17.59) | 146 (18.30) | 133 (24.81) | 12 (17.64) | 8 (24.24) | 279 (15.75) | 220 (21.61) |
| 2016 | 163 (18.01) | 95 (21.16) | 187 (23.43) | 107 (19.96) | 21 (30.88) | 10 (30.30) | 371 (20.95) | 212 (20.83) |
a
The first quarter of 2021. N, number of adverse event reported.