List of 61 drugs associated with ITP with significant disproportional reporting, classified by decreasing ROR
“Suspect”/“interacting” drug . | n ITP/drug . | ROR (95% CI) . | Median onset of ITP after starting drug . | Fatal outcomes . | |
---|---|---|---|---|---|
Median onset (days) . | Data available for n notifications . | n (%) . | |||
Alemtuzumab | 239 | 161.5 (140.9-185.1) | 352 (221-492) | 33 (14%) | 9 (4) |
Immunoglobulin human anti-rabies | 8 | 83.4 (41.5-167.5) | — | — | 0 |
Guanfacine | 10 | 39.4 (21.1-73.3) | — | — | 0 |
Measles and rubella vaccine | 10 | 22.7 (12.2-42.3) | 16 (7-22) | 9 (90%) | 0 |
HIB vaccine | 68 | 16.8 (13.2-21.4) | 8 (2-15) | 55 (81%) | 0 |
Measles, mumps, rubella, and varicella-zoster vaccine | 39 | 16.1 (11.7-22.2) | 21 (11.75-27) | 32 (82%) | 0 |
Rabies vaccine | 14 | 16.1 (9.5-27.2) | < 1 | 1 (7%) | 0 |
Hepatitis B vaccine | 76 | 15.0 (11.9-18.8) | 12 (7-24) | 57 (75%) | 0 |
Hepatitis A vaccine | 43 | 11.3 (8.4-15.3) | 16.5 (7.75-30.75) | 36 (84%) | 1 (2) |
Measles, mumps, and rubella vaccine | 114 | 10.9 (9.0-13.2) | 19 (9-24) | 93 (82%) | 2 (2) |
Nivolumab | 47 | 10.5 (7.8-14.0) | 89.5 (32-237) | 6 (13%) | 8 (17) |
Fludarabine | 11 | 10.1 (5.6-18.3) | 9 | 1 (9%) | 2 (18) |
Busulfan | 5 | 10.1 (4.2-24.3) | — | — | 2 (40) |
Temozolomide | 13 | 9.7 (5.6-16.8) | — | — | 1 (8) |
Rotavirus vaccine | 54 | 9.5 (7.3-12.5) | 10 (3.75-13.75) | 44 (81%) | 0 |
Pembrolizumab | 24 | 9.4 (6.3-14.1) | 213 (77-441) | 5 (21%) | 3 (13) |
Meningococcal vaccine | 73 | 8.6 (6.8-10.8) | 9.5 (5.25-20) | 54 (74%) | 0 |
Ipilimumab | 17 | 8.5 (5.3-13.7) | 23 | 1 (6%) | 2 (12) |
Typhoid vaccine | 9 | 8.3 (4.3-15.9) | 12 (2-14) | 5 (56%) | 0 |
Folinic acid | 15 | 8.1 (4.9-13.5) | — | — | 0 |
Pneumococcal vaccine | 136 | 7.4 (6.2-8.8) | 9.5 (2-22) | 108 (79%) | 0 |
Ibrutinib | 27 | 7.1 (4.9-10.4) | — | — | 2 (7) |
Irinotecan | 23 | 6.9 (4.6-10.4) | — | — | 0 |
Losartan | 13 | 6.7 (3.9-11.6) | 37 | 1 (8%) | 0 |
Venetoclax | 8 | 6.2 (3.1-12.3) | 130 | 1 (13%) | 0 |
Doxycycline | 15 | 6.0 (3.6-10.0) | 20.5 (15.75-25.25) | 2 (13%) | 0 |
Melphalan | 5 | 5.9 (2.5-14.2) | 357 | 1 (20%) | 0 |
Diphtheria, pertussis, polio, and tetanus vaccine | 26 | 5.9 (4.0-8.7) | 13 (4-21.5) | 19 (73%) | 0 |
Polio vaccine | 38 | 5.9 (4.3-8.1) | 7 (2-11) | 33 (87%) | 0 |
HPV vaccine | 58 | 5.8 (4.4-7.5) | 14 (5.5-40.5) | 47 (81%) | 0 |
Filgrastim | 6 | 4.8 (2.2-10.7) | — | — | 0 |
Eculizumab | 18 | 4.7 (2.9-7.5) | — | — | 1 (6) |
Tacrolimus | 24 | 4.4 (2.9-6.5) | 42 (36-164) | 3 (13%) | 1 (4) |
Oxaliplatin | 35 | 4.3 (3.0-5.9) | 2 | 1 (3%) | 0 |
Diphtheria, hepatitis B, HIB, pertussis, polio and tetanus vaccine | 18 | 4.2 (2.6-6.7) | 11 (3.75-18) | 16 (89%) | 0 |
Vancomycin | 22 | 4.2 (2.8-6.4) | — | — | 0 |
Cephalexin | 7 | 4.2 (2.0-8.7) | — | — | 0 |
Ifosfamide | 5 | 4.0 (1.7-9.7) | — | — | 0 |
Ondansetron | 6 | 3.9 (1.7-8.6) | — | — | 0 |
Fingolimod | 30 | 3.7 (2.6-5.4) | 983 (706-1155.5) | 2 (7%) | 1 (3) |
Acyclovir | 6 | 3.7 (1.7-8.3) | — | — | 0 |
Sofosbuvir | 7 | 3.7 (1.8-7.8) | — | — | 0 |
Yellow fever vaccine | 8 | 3.6 (1.8-7.2) | 14 (7-14) | 3 (38%) | 0 |
Diphtheria, pertussis, and tetanus vaccine | 47 | 3.5 (2.6-4.7) | 10 (7-16) | 41 (87%) | 0 |
Influenza vaccine | 70 | 3.4 (2.6-4.3) | 11 (4.75-22.25) | 52 (74%) | 2 (3) |
Bisoprolol | 6 | 3.3 (1.5-7.3) | 33 | 1 (17%) | 0 |
Sulfamethoxazole; trimethoprim | 22 | 3.1 (2.1-4.8) | 11.5 (7.75-25) | 6 (27%) | 2 (9) |
Peginterferon alfa-2b | 5 | 3.0 (1.3;7.3) | — | — | 0 |
Varicella-zoster vaccine | 45 | 3.0 (2.2-4.0) | 14 (8.5-23) | 39 (87%) | 1 (2) |
Clopidogrel | 17 | 3.0 (1.8-4.8) | 21 | 1 (6%) | 0 |
Ticagrelor | 6 | 2.9 (1.3-6.4) | 19.5 (15.25-23.75) | 2 (33%) | 0 |
Diphtheria, HIB, pertussis, polio, and tetanus vaccine | 8 | 2.8 (1.4-5.7) | 5.5 (1-12.25) | 6 (75%) | 0 |
Sunitinib | 9 | 2.8 (1.4-5.3) | 55 (54.5-55.5) | 2 (22%) | 1 (11) |
Ethinylestradiol; etonogestrel | 6 | 2.7 (1.2-6.0) | — | — | 0 |
Peginterferon alfa-2a | 12 | 2.7 (1.5-4.7) | — | — | 1 (8) |
Rivaroxaban | 33 | 2.5 (1.8-3.5) | 34 | 1 (3%) | 5 (15) |
Vedolizumab | 5 | 2.4 (1.0-5.8) | — | — | 0 |
Ribavirin | 19 | 2.4 (1.5-3.7) | — | — | 1 (5) |
Teriflunomide | 7 | 2.2 (1.1-4.7) | — | — | 0 |
Doxorubicin | 14 | 2.0 (1.2-3.4) | — | — | 0 |
Acetylsalicylic acid | 26 | 1.8 (1.2-2.7) | 20 (16.5-895) | 3 (12%) | 1 (4) |
Total | 1787 notifications 1245 ICSRs | 12 (10.5-33.5) | 823 notifications (46%) 488 ICSRs (39%) | 49 notifications 40 ICSRs Data available for 1231 ICSRs (99%) |
“Suspect”/“interacting” drug . | n ITP/drug . | ROR (95% CI) . | Median onset of ITP after starting drug . | Fatal outcomes . | |
---|---|---|---|---|---|
Median onset (days) . | Data available for n notifications . | n (%) . | |||
Alemtuzumab | 239 | 161.5 (140.9-185.1) | 352 (221-492) | 33 (14%) | 9 (4) |
Immunoglobulin human anti-rabies | 8 | 83.4 (41.5-167.5) | — | — | 0 |
Guanfacine | 10 | 39.4 (21.1-73.3) | — | — | 0 |
Measles and rubella vaccine | 10 | 22.7 (12.2-42.3) | 16 (7-22) | 9 (90%) | 0 |
HIB vaccine | 68 | 16.8 (13.2-21.4) | 8 (2-15) | 55 (81%) | 0 |
Measles, mumps, rubella, and varicella-zoster vaccine | 39 | 16.1 (11.7-22.2) | 21 (11.75-27) | 32 (82%) | 0 |
Rabies vaccine | 14 | 16.1 (9.5-27.2) | < 1 | 1 (7%) | 0 |
Hepatitis B vaccine | 76 | 15.0 (11.9-18.8) | 12 (7-24) | 57 (75%) | 0 |
Hepatitis A vaccine | 43 | 11.3 (8.4-15.3) | 16.5 (7.75-30.75) | 36 (84%) | 1 (2) |
Measles, mumps, and rubella vaccine | 114 | 10.9 (9.0-13.2) | 19 (9-24) | 93 (82%) | 2 (2) |
Nivolumab | 47 | 10.5 (7.8-14.0) | 89.5 (32-237) | 6 (13%) | 8 (17) |
Fludarabine | 11 | 10.1 (5.6-18.3) | 9 | 1 (9%) | 2 (18) |
Busulfan | 5 | 10.1 (4.2-24.3) | — | — | 2 (40) |
Temozolomide | 13 | 9.7 (5.6-16.8) | — | — | 1 (8) |
Rotavirus vaccine | 54 | 9.5 (7.3-12.5) | 10 (3.75-13.75) | 44 (81%) | 0 |
Pembrolizumab | 24 | 9.4 (6.3-14.1) | 213 (77-441) | 5 (21%) | 3 (13) |
Meningococcal vaccine | 73 | 8.6 (6.8-10.8) | 9.5 (5.25-20) | 54 (74%) | 0 |
Ipilimumab | 17 | 8.5 (5.3-13.7) | 23 | 1 (6%) | 2 (12) |
Typhoid vaccine | 9 | 8.3 (4.3-15.9) | 12 (2-14) | 5 (56%) | 0 |
Folinic acid | 15 | 8.1 (4.9-13.5) | — | — | 0 |
Pneumococcal vaccine | 136 | 7.4 (6.2-8.8) | 9.5 (2-22) | 108 (79%) | 0 |
Ibrutinib | 27 | 7.1 (4.9-10.4) | — | — | 2 (7) |
Irinotecan | 23 | 6.9 (4.6-10.4) | — | — | 0 |
Losartan | 13 | 6.7 (3.9-11.6) | 37 | 1 (8%) | 0 |
Venetoclax | 8 | 6.2 (3.1-12.3) | 130 | 1 (13%) | 0 |
Doxycycline | 15 | 6.0 (3.6-10.0) | 20.5 (15.75-25.25) | 2 (13%) | 0 |
Melphalan | 5 | 5.9 (2.5-14.2) | 357 | 1 (20%) | 0 |
Diphtheria, pertussis, polio, and tetanus vaccine | 26 | 5.9 (4.0-8.7) | 13 (4-21.5) | 19 (73%) | 0 |
Polio vaccine | 38 | 5.9 (4.3-8.1) | 7 (2-11) | 33 (87%) | 0 |
HPV vaccine | 58 | 5.8 (4.4-7.5) | 14 (5.5-40.5) | 47 (81%) | 0 |
Filgrastim | 6 | 4.8 (2.2-10.7) | — | — | 0 |
Eculizumab | 18 | 4.7 (2.9-7.5) | — | — | 1 (6) |
Tacrolimus | 24 | 4.4 (2.9-6.5) | 42 (36-164) | 3 (13%) | 1 (4) |
Oxaliplatin | 35 | 4.3 (3.0-5.9) | 2 | 1 (3%) | 0 |
Diphtheria, hepatitis B, HIB, pertussis, polio and tetanus vaccine | 18 | 4.2 (2.6-6.7) | 11 (3.75-18) | 16 (89%) | 0 |
Vancomycin | 22 | 4.2 (2.8-6.4) | — | — | 0 |
Cephalexin | 7 | 4.2 (2.0-8.7) | — | — | 0 |
Ifosfamide | 5 | 4.0 (1.7-9.7) | — | — | 0 |
Ondansetron | 6 | 3.9 (1.7-8.6) | — | — | 0 |
Fingolimod | 30 | 3.7 (2.6-5.4) | 983 (706-1155.5) | 2 (7%) | 1 (3) |
Acyclovir | 6 | 3.7 (1.7-8.3) | — | — | 0 |
Sofosbuvir | 7 | 3.7 (1.8-7.8) | — | — | 0 |
Yellow fever vaccine | 8 | 3.6 (1.8-7.2) | 14 (7-14) | 3 (38%) | 0 |
Diphtheria, pertussis, and tetanus vaccine | 47 | 3.5 (2.6-4.7) | 10 (7-16) | 41 (87%) | 0 |
Influenza vaccine | 70 | 3.4 (2.6-4.3) | 11 (4.75-22.25) | 52 (74%) | 2 (3) |
Bisoprolol | 6 | 3.3 (1.5-7.3) | 33 | 1 (17%) | 0 |
Sulfamethoxazole; trimethoprim | 22 | 3.1 (2.1-4.8) | 11.5 (7.75-25) | 6 (27%) | 2 (9) |
Peginterferon alfa-2b | 5 | 3.0 (1.3;7.3) | — | — | 0 |
Varicella-zoster vaccine | 45 | 3.0 (2.2-4.0) | 14 (8.5-23) | 39 (87%) | 1 (2) |
Clopidogrel | 17 | 3.0 (1.8-4.8) | 21 | 1 (6%) | 0 |
Ticagrelor | 6 | 2.9 (1.3-6.4) | 19.5 (15.25-23.75) | 2 (33%) | 0 |
Diphtheria, HIB, pertussis, polio, and tetanus vaccine | 8 | 2.8 (1.4-5.7) | 5.5 (1-12.25) | 6 (75%) | 0 |
Sunitinib | 9 | 2.8 (1.4-5.3) | 55 (54.5-55.5) | 2 (22%) | 1 (11) |
Ethinylestradiol; etonogestrel | 6 | 2.7 (1.2-6.0) | — | — | 0 |
Peginterferon alfa-2a | 12 | 2.7 (1.5-4.7) | — | — | 1 (8) |
Rivaroxaban | 33 | 2.5 (1.8-3.5) | 34 | 1 (3%) | 5 (15) |
Vedolizumab | 5 | 2.4 (1.0-5.8) | — | — | 0 |
Ribavirin | 19 | 2.4 (1.5-3.7) | — | — | 1 (5) |
Teriflunomide | 7 | 2.2 (1.1-4.7) | — | — | 0 |
Doxorubicin | 14 | 2.0 (1.2-3.4) | — | — | 0 |
Acetylsalicylic acid | 26 | 1.8 (1.2-2.7) | 20 (16.5-895) | 3 (12%) | 1 (4) |
Total | 1787 notifications 1245 ICSRs | 12 (10.5-33.5) | 823 notifications (46%) 488 ICSRs (39%) | 49 notifications 40 ICSRs Data available for 1231 ICSRs (99%) |
HIB, Haemophilus influenzae type b; HPV, human papillomavirus.