Table. Age- and Sex-Adjusted Incidence Rates of Hospitalization for Severe Acute Liver Injury for Group 1 and 2 Medicationsa.
| Medication | Hepatotoxicity categoryb | No. of initiators | Age, median (IQR), y | Male, No. (%) | Female, No. (%) | No. of person-years | No. of events | Adjusted incidence rate (95% CI), events per 10 000 person-yearsc |
|---|---|---|---|---|---|---|---|---|
| Group 1 (≥10.0 events per 10 000 person-years) | ||||||||
| Stavudined | B | 750 | 48.5 (42.0-54.8) | 724 (96.5) | 26 (3.5) | 306 | 3 | 86.4 (27.7-269.7) |
| Erlotinib | C | 4356 | 71.3 (64.4-78.7) | 4225 (97.0) | 131 (3.0) | 1133 | 4 | 19.7 (7.4-53.0) |
| Lenalidomide or thalidomide | C | 8191 | 71.8 (65.4-78.2) | 7975 (97.4) | 216 (2.6) | 2860 | 7 | 13.7 (6.4-28.9) |
| Chlorpromazine | A | 17 449 | 60.4 (49.7-69.7) | 16 253 (93.1) | 1196 (6.9) | 2542 | 4 | 12.0 (4.5-32.3) |
| Metronidazoled | C | 423 666 | 57.6 (43.6-68.2) | 309 774 (73.1) | 113 892 (26.9) | 12 340 | 19 | 11.8 (7.4-18.7) |
| Prochlorperazine | C | 167 779 | 63.5 (51.9-72.2) | 145 045 (86.5) | 22 734 (13.5) | 11 999 | 20 | 11.6 (7.4-18.2) |
| Isoniazidd | A | 20 476 | 58.6 (47.4-69.2) | 18 719 (91.4) | 1757 (8.6) | 7642 | 11 | 10.5 (5.8-19.2) |
| Group 2 (5.0-9.9 events per 10 000 person-years) | ||||||||
| Moxifloxacind | B | 376 367 | 63.9 (56.1-73.7) | 346 663 (92.1) | 29 704 (7.9) | 11 141 | 16 | 9.3 (5.6-15.4) |
| Azathioprine or mercaptopurine | A | 16 033 | 62.6 (50.3-71.3) | 14 188 (88.5) | 1845 (11.5) | 6305 | 7 | 7.7 (3.7-16.4) |
| Levofloxacin or ofloxacind | B | 580 210 | 65.9 (55.8-73.9) | 537 103 (92.6) | 43 107 (7.4) | 18 799 | 21 | 7.2 (4.6-11.1) |
| Clarithromycind | B | 210 356 | 61.8 (52.0-70.9) | 190 190 (90.4) | 20 166 (9.6) | 8169 | 8 | 6.7 (3.3-13.5) |
| Ketoconazoled | A | 29 976 | 59.0 (45.5-70.5) | 27 763 (92.6) | 2213 (7.4) | 2980 | 3 | 6.1 (2.0-19.0) |
| Fluconazoled | B | 287 646 | 55.6 (40.7-67.7) | 172 110 (59.8) | 115 536 (40.2) | 16 008 | 13 | 6.0 (3.4-10.4) |
| Captopril | B | 18 863 | 70.5 (60.4-78.3) | 18 378 (97.4) | 485 (2.6) | 6859 | 7 | 5.8 (2.7-12.2) |
| Amoxicillin with clavulanated | A | 1 235 143 | 60.6 (49.2-69.9) | 1 114 900 (90.3) | 120 243 (9.7) | 38 233 | 29 | 5.4 (3.7-7.9) |
| Sulfamethoxazole with trimethoprimd | A | 1 025 123 | 62.9 (52.0-71.8) | 915 649 (89.3) | 109 474 (10.7) | 42 145 | 32 | 5.1 (3.5-7.3) |
| Ciprofloxacind | B | 1 125 460 | 64.8 (56.3-73.2) | 1 028 351 (91.4) | 97 109 (8.6) | 36 803 | 29 | 5.1 (3.5-7.4) |
Rates of severe acute liver injury were assessed among patients without preexisting liver or biliary disease and after censoring for incident diagnoses of liver or biliary diseases or other conditions that may precipitate findings consistent with liver injury.
Based on published reports. Original category as defined by Björnsson and Hoofnagle.6 Medications listed in the US National Institutes of Health LiverTox database were classified into categories of likelihood for causing acute liver injury based on the number of published reports of hepatotoxicity (category A, ≥50 cases; category B, 12-49 cases; category C, 4-11 cases).
Incidence rates adjusted for age and sex.
Represents antimicrobial (ie, antibacterial, antiviral, or antifungal) medications.