primaryid
string
caseid
string
caseversion
string
i_f_code
string
event_dt
string
mfr_dt
string
init_fda_dt
string
fda_dt
string
rept_cod
string
auth_num
string
mfr_num
string
mfr_sndr
string
lit_ref
string
age
string
age_cod
string
age_grp
string
sex
string
e_sub
string
wt
string
wt_cod
string
rept_dt
string
to_mfr
string
occp_cod
string
reporter_country
string
occr_country
string
228584031
22858403
1
I
null
20230818
20230824
20230824
EXP
null
AT-NOVITIUMPHARMA-2023ATNVP01402
NOVITIUM PHARMA
Franz Martin Fink.Case report: metoclopramide induced acute dystonic reaction in adolescent CYP2D6 poor metabolizers.Frontiers in Pharmacology.11-JUL-2023;14:1-5
14
YR
T
M
Y
62
KG
20230824
null
HP
AT
AT
228584041
22858404
1
I
null
20230816
20230824
20230824
EXP
null
JP-STL-000133
Stallion Laboratories
Saito S, Iijima M, Ikeguchi R, Ishizuka K, Kitagawa K. Four Cases of Suspected Levetiracetam-Induced Asymptomatic Rhabdomyolysis. Cureus. 2023 Jul 10;15(7):e41666. doi: 10.7759/cureus.41666.
25
YR
null
F
Y
null
null
20230823
null
HP
JP
JP
228584061
22858406
1
I
null
20230820
20230824
20230824
EXP
null
CA-002147023-NVSC2020CA079525
SANDOZ
null
44
YR
null
F
Y
null
null
20230824
null
CN
CA
CA
228584071
22858407
1
I
null
20230816
20230824
20230824
EXP
null
JP-STL-000134
Stallion Laboratories
Saito S, Iijima M, Ikeguchi R, Ishizuka K, Kitagawa K. Four Cases of Suspected Levetiracetam-Induced Asymptomatic Rhabdomyolysis. Cureus. 2023 Jul 10;15(7):e41666. doi: 10.7759/cureus.41666.
32
YR
null
M
Y
null
null
20230823
null
HP
JP
JP
228584081
22858408
1
I
null
20230728
20230824
20230824
EXP
null
US-SANDOZ-SDZ2023US017485
SANDOZ
null
null
null
null
F
Y
67.73
KG
20230824
null
HP
US
US
228584112
22858411
2
F
20230818
20230823
20230824
20230828
EXP
null
US-ABBVIE-5378307
ABBVIE
null
67
YR
null
F
Y
null
null
20230828
null
CN
US
US
228584121
22858412
1
I
null
20230818
20230824
20230824
EXP
null
HU-002147023-NVSC2023HU088347
SANDOZ
null
null
null
E
F
Y
null
null
20230824
null
CN
HU
HU
228584131
22858413
1
I
null
20230823
20230824
20230824
EXP
null
NVSC2023US183901
NOVARTIS
null
null
null
null
M
Y
null
null
20230824
null
HP
US
US
228584141
22858414
1
I
20230821
20230821
20230824
20230824
PER
null
US-AMGEN-USASP2023149180
AMGEN
null
null
null
null
F
Y
null
null
20230823
null
CN
US
US
228584151
22858415
1
I
null
20230821
20230824
20230824
PER
null
US-BEIGENE-BGN-2023-008914
BEIGENE
null
null
null
null
null
Y
null
null
20230824
null
CN
US
US
228584161
22858416
1
I
null
20230823
20230824
20230824
PER
null
US-BRISTOL-MYERS SQUIBB COMPANY-2023-118925
BRISTOL MYERS SQUIBB
null
73
YR
E
F
Y
null
null
20230824
null
HP
US
US
228584182
22858418
2
F
20230202
20230911
20230824
20230918
EXP
PT-INFARMED-T202308-452
PT-AMGEN-PRTSP2023148746
AMGEN
null
75
YR
E
F
Y
null
null
20230918
null
MD
PT
PT
228584191
22858419
1
I
null
20230821
20230824
20230824
PER
null
US-AMGEN-USASP2023149526
AMGEN
null
null
null
null
null
Y
null
null
20230823
null
PH
US
US
228584201
22858420
1
I
null
20230821
20230824
20230824
EXP
null
KR-ROCHE-3408710
ROCHE
Park C, Lee H, Kang K, Lee W, Do Y, Kwak J, Shin H, Kim S, Yi J, Lim S, Lee J, Yang D, Byun J, Yoon S and Koh Y Combination of acalabrutinib with rituximab and lenalidomide in relapsed/refractory B cell non-Hodgkin lymphoma [Abstract no: 326]. DOI:10.1002/hon.3164_326. Hematological Oncology 2023 Jun 01;41 (S2):443-.
null
null
null
null
Y
null
null
20230824
null
HP
KR
null
228584211
22858421
1
I
null
20230816
20230824
20230824
EXP
null
US-BEIGENE-BGN-2023-008725
BEIGENE
null
null
null
null
null
Y
null
null
20230824
null
CN
US
US
228584221
22858422
1
I
20230627
20230821
20230824
20230824
EXP
null
CN-ROCHE-3409292
ROCHE
null
63
YR
null
M
Y
74
KG
20230824
null
HP
CN
null
228584231
22858423
1
I
null
20230821
20230824
20230824
EXP
null
PL-NOVITIUMPHARMA-2023PLNVP01407
NOVITIUM PHARMA
Konrad Szymanski.Case Report: Biological treatment of epidermolysis bullosa acquisita: report on four cases and literature review.Frontiers in Immunology.12-JUL-2023;14:1-9
null
null
E
F
Y
null
null
20230824
null
HP
PL
PL
228584242
22858424
2
F
null
20230606
20230824
20230828
EXP
null
US-SANDOZ INC.-SDZ2023US017432
SANDOZ
null
null
null
null
F
Y
null
null
20230828
null
HP
US
US
228584251
22858425
1
I
null
20230811
20230824
20230824
EXP
null
US-PADAGIS-2023PAD01169
PADAGIS
Ahmad TK, Huynha LM, Raghub R, Solimanc KM, Henrya W, Sallama A. Intravitreal Triamcinolone Acetonide Presents a Diagnostic Challenge on Noncontrast Computed Tomography. Case Reports in Opthomology. 2022;13(1):243-246
null
null
null
null
Y
null
null
20230824
null
HP
US
US
228584261
22858426
1
I
20221216
20230815
20230824
20230824
EXP
FR-AFSSAPS-CN2023000695
FR-SANDOZ-SDZ2023FR017673
SANDOZ
null
37
YR
null
M
Y
null
null
20230824
null
MD
FR
FR
228584271
22858427
1
I
null
20230605
20230824
20230824
EXP
null
US-SANDOZ-SDZ2023US017519
SANDOZ
null
null
null
null
F
Y
113.64
KG
20230824
null
HP
US
US
228584281
22858428
1
I
null
20230815
20230824
20230824
EXP
null
US-JNJFOC-20230834529
JOHNSON AND JOHNSON
null
null
null
null
null
Y
null
null
20230824
null
MD
US
US
228584291
22858429
1
I
20171130
20230816
20230824
20230824
EXP
null
CA-002147023-PHHY2017CA179388
SANDOZ
null
63
YR
null
F
Y
null
null
20230824
null
CN
CA
CA
228584312
22858431
2
F
null
20230921
20230824
20230926
PER
null
US-LUNDBECK-DKLU3066426
LUNDBECK
null
55
YR
null
M
Y
null
null
20230927
null
CN
US
US
228584321
22858432
1
I
null
20230814
20230824
20230824
EXP
null
DE-SANDOZ-SDZ2023DE015194
SANDOZ
null
null
null
null
F
Y
null
null
20230824
null
CN
DE
DE
228584331
22858433
1
I
20230616
20230731
20230824
20230824
EXP
null
CA-SANDOZ-SDZ2023CA008427
SANDOZ
null
78
YR
null
M
Y
null
null
20230824
null
PH
CA
CA
228584341
22858434
1
I
null
20230608
20230824
20230824
EXP
null
US-SANDOZ-SDZ2023US017422
SANDOZ
null
null
null
null
F
Y
109.09
KG
20230824
null
MD
US
US
228584351
22858435
1
I
20230723
20230811
20230824
20230824
EXP
null
FR-VALIDUS PHARMACEUTICALS LLC-FR-VDP-2023-016229
VALIDUS
null
null
null
null
null
Y
null
null
20230824
null
MD
FR
FR
228584361
22858436
1
I
20230725
20230725
20230824
20230824
EXP
null
US-SANDOZ-SDZ2023US016683
SANDOZ
null
52
YR
null
F
Y
91.61
KG
20230824
null
MD
US
US
228584371
22858437
1
I
null
20230815
20230824
20230824
EXP
null
CZ-SANDOZ-SDZ2023CZ000205
SANDOZ
null
6
YR
null
M
Y
16.5
KG
20230824
null
MD
CZ
CZ
228584381
22858438
1
I
null
20230821
20230824
20230824
PER
null
US-ELI_LILLY_AND_COMPANY-US202308013433
ELI LILLY AND CO
null
null
null
null
F
Y
null
null
20230824
null
CN
US
US
228584411
22858441
1
I
20230801
20230822
20230824
20230824
PER
null
US-ELI_LILLY_AND_COMPANY-US202308013687
ELI LILLY AND CO
null
59
YR
null
F
Y
null
null
20230824
null
CN
US
US
228584421
22858442
1
I
20230821
20230822
20230824
20230824
PER
null
US-ELI_LILLY_AND_COMPANY-US202308013892
ELI LILLY AND CO
null
66
YR
null
F
Y
null
null
20230824
null
CN
US
US
228584431
22858443
1
I
20230821
20230822
20230824
20230824
PER
null
US-ELI_LILLY_AND_COMPANY-US202308013683
ELI LILLY AND CO
null
55
YR
null
null
Y
null
null
20230824
null
CN
US
US
228584441
22858444
1
I
20230820
20230821
20230824
20230824
PER
null
US-ELI_LILLY_AND_COMPANY-US202308012949
ELI LILLY AND CO
null
52
YR
null
F
Y
null
null
20230824
null
CN
US
US
228584451
22858445
1
I
null
20230818
20230824
20230824
PER
null
US-ELI_LILLY_AND_COMPANY-US202308012055
ELI LILLY AND CO
null
null
null
null
F
Y
null
null
20230824
null
CN
US
US
228584461
22858446
1
I
null
20230822
20230824
20230824
PER
null
US-ELI_LILLY_AND_COMPANY-US202308013858
ELI LILLY AND CO
null
null
null
null
F
Y
null
null
20230824
null
CN
US
US
228584471
22858447
1
I
null
20230814
20230824
20230824
PER
null
US-ELI_LILLY_AND_COMPANY-US202308008733
ELI LILLY AND CO
null
59
YR
null
F
Y
null
null
20230824
null
CN
US
US
228584481
22858448
1
I
20230821
20230821
20230824
20230824
PER
null
US-ELI_LILLY_AND_COMPANY-US202308013017
ELI LILLY AND CO
null
65
YR
null
null
Y
null
null
20230824
null
CN
US
US
228584491
22858449
1
I
null
20230816
20230824
20230824
PER
null
US-ELI_LILLY_AND_COMPANY-US202308011535
ELI LILLY AND CO
null
48
YR
null
F
Y
null
null
20230824
null
CN
US
US
228584501
22858450
1
I
20230821
20230822
20230824
20230824
PER
null
US-ELI_LILLY_AND_COMPANY-US202308013685
ELI LILLY AND CO
null
53
YR
null
F
Y
null
null
20230824
null
CN
US
US
228584521
22858452
1
I
20230822
20230822
20230824
20230824
PER
null
US-AMGEN-USASP2023148854
AMGEN
null
null
null
null
M
Y
null
null
20230824
null
MD
US
US
228584531
22858453
1
I
20230821
20230822
20230824
20230824
PER
null
US-AMGEN-USASP2023148874
AMGEN
null
67
YR
E
F
Y
null
null
20230824
null
CN
US
US
228584541
22858454
1
I
20230801
20230821
20230824
20230824
PER
null
US-AMGEN-USASP2023149461
AMGEN
null
74
YR
E
F
Y
null
null
20230824
null
CN
US
US
228584571
22858457
1
I
null
20200107
20230824
20230824
PER
null
US-009507513-2306USA004221
MERCK
null
null
null
null
null
Y
null
null
20230824
null
MD
US
US
228584581
22858458
1
I
null
20230821
20230824
20230824
PER
null
US-AMGEN-USASP2023149519
AMGEN
null
null
null
null
null
Y
null
null
20230824
null
CN
US
US
228584593
22858459
3
F
20230816
20230823
20230824
20230830
PER
null
US-AMGEN-USASP2023148330
AMGEN
null
82
YR
E
F
Y
null
null
20230830
null
HP
US
US
228584604
22858460
4
F
20230801
20230914
20230824
20230916
PER
null
US-AMGEN-USASP2023149106
AMGEN
null
50
YR
A
F
Y
139
KG
20230915
null
HP
US
US
228584632
22858463
2
F
20230608
20230825
20230824
20230831
EXP
null
AU-SA-2023SA201552
SANOFI AVENTIS
null
81
YR
E
F
Y
null
null
20230831
null
HP
AU
AU
228584642
22858464
2
F
20230731
20230905
20230824
20230911
EXP
null
AT-SAKK-2023SA238075AA
SANOFI AVENTIS
null
80
YR
E
M
Y
73
KG
20230911
null
HP
AT
AT
228584661
22858466
1
I
20230101
20230821
20230824
20230824
EXP
null
CA-JNJFOC-20230848557
JOHNSON AND JOHNSON
null
73
YR
E
F
Y
null
null
20230824
null
CN
CA
CA
228584671
22858467
1
I
20230206
20230822
20230824
20230824
EXP
null
DE-SANDOZ-SDZ2023DE017303
SANDOZ
null
58
YR
null
M
Y
null
null
20230824
null
MD
DE
DE
228584681
22858468
1
I
null
20230818
20230824
20230824
PER
null
US-Blueprint Medicines Corporation-SP-US-2023-001262
BLUEPRINT MEDICINES
null
null
null
null
F
Y
null
null
20230824
null
CN
US
US
228584692
22858469
2
F
20230814
20230926
20230824
20230928
EXP
null
US-BRISTOL-MYERS SQUIBB COMPANY-2023-118879
BRISTOL MYERS SQUIBB
null
80
YR
E
M
Y
null
null
20230928
null
CN
US
US
228584701
22858470
1
I
null
20230821
20230824
20230824
EXP
null
CN-SANDOZ-SDZ2023CN016951
SANDOZ
Liu Xiaolong , Pang Jing. One critically ill case of severe rhabdomyolysis syndrome was reported. Chinese Folk Therapy. 2023;31:102-104
67
YR
null
F
Y
null
null
20230824
null
HP
CN
CN
228584711
22858471
1
I
null
20230728
20230824
20230824
EXP
null
US-SANDOZ-SDZ2023US017474
SANDOZ
null
null
null
null
M
Y
null
null
20230824
null
CN
US
US
228584721
22858472
1
I
20230320
20230822
20230824
20230824
EXP
null
AE-ROCHE-3357640
ROCHE
null
44
YR
null
F
Y
null
null
20230824
null
CN
AE
null
228584731
22858473
1
I
null
20230814
20230824
20230824
EXP
null
ZA-LUPIN PHARMACEUTICALS INC.-2023-07033
LUPIN
null
null
null
null
null
Y
null
null
20230824
null
CN
ZA
ZA
228584741
22858474
1
I
null
20230818
20230824
20230824
30DAY
null
US-GSK-US2023112747
GLAXOSMITHKLINE
null
null
null
A
M
Y
null
null
20230824
null
CN
US
US
228584751
22858475
1
I
null
20230814
20230824
20230824
EXP
null
US-GSK-US2023110200
GLAXOSMITHKLINE
null
null
null
null
F
Y
null
null
20230824
null
CN
US
US
228584761
22858476
1
I
null
20230821
20230824
20230824
EXP
null
US-GLAXOSMITHKLINE-USCH2023040612
GLAXOSMITHKLINE
null
null
null
null
null
Y
null
null
20230824
null
CN
US
US
228584771
22858477
1
I
null
20230817
20230824
20230824
EXP
null
US-JNJFOC-20230844411
JOHNSON AND JOHNSON
null
null
null
null
F
Y
null
null
20230824
null
CN
US
US
228584791
22858479
1
I
null
20230821
20230824
20230824
PER
null
US-TAKEDA-2023TUS081999
TAKEDA
null
null
null
null
M
Y
64
KG
20230824
null
MD
US
US
228584801
22858480
1
I
null
20230815
20230824
20230824
EXP
null
CA-APOTEX-2023AP012365
APOTEX
null
27
YR
null
F
Y
null
null
20230824
null
HP
CA
CA
228584821
22858482
1
I
null
20230822
20230824
20230824
PER
null
US-AMGEN-USASP2023149866
AMGEN
null
null
null
null
null
Y
null
null
20230824
null
PH
US
US
228584831
22858483
1
I
null
20230818
20230824
20230824
EXP
null
CA-TAKEDA-2023TUS081496
TAKEDA
null
null
null
null
M
Y
null
null
20230824
null
CN
CA
CA
228584841
22858484
1
I
20190730
20230820
20230824
20230824
EXP
null
US-ROCHE-2903648
ROCHE
null
73
YR
null
F
Y
63.5
KG
20230824
null
MD
US
null
228584861
22858486
1
I
null
20230817
20230824
20230824
30DAY
null
US-SANDOZ INC.-SDZ2023US017197
SANDOZ
null
31
YR
null
F
Y
null
null
20230824
null
CN
US
US
228584872
22858487
2
F
20230811
20230914
20230824
20230921
EXP
null
CZ-SANDOZ INC.-SDZ2023CZ016985
SANDOZ
null
35
YR
null
F
Y
51.5
KG
20230921
null
MD
CZ
CZ
228584881
22858488
1
I
null
20230820
20230824
20230824
EXP
null
NVSC2023CA182833
NOVARTIS
null
38
YR
null
F
Y
null
null
20230824
null
HP
CA
CA
228584891
22858489
1
I
null
20230818
20230824
20230824
PER
null
US-AMGEN-USASP2023148720
AMGEN
null
54
YR
A
F
Y
null
null
20230824
null
MD
US
US
228584901
22858490
1
I
null
20230821
20230824
20230824
EXP
null
US-JNJFOC-20230848367
JOHNSON AND JOHNSON
null
null
null
null
null
Y
null
null
20230824
null
CN
US
US
228584911
22858491
1
I
20230103
20230821
20230824
20230824
EXP
AT-EMA-DD-20230816-7180175-110432
AT-JNJFOC-20230849316
JOHNSON AND JOHNSON
null
61
YR
A
M
Y
67
KG
20230824
null
MD
AT
AT
228584921
22858492
1
I
null
20230823
20230824
20230824
PER
null
US-BRISTOL-MYERS SQUIBB COMPANY-2023-118931
BRISTOL MYERS SQUIBB
null
75
YR
E
M
Y
null
null
20230824
null
HP
US
US
228584941
22858494
1
I
null
20230823
20230824
20230824
PER
null
US-BRISTOL-MYERS SQUIBB COMPANY-2023-118933
BRISTOL MYERS SQUIBB
null
46
YR
A
M
Y
null
null
20230824
null
HP
US
US
228584951
22858495
1
I
20230725
20230817
20230824
20230824
EXP
null
CN-ROCHE-3407633
ROCHE
null
65
YR
null
F
Y
49
KG
20230824
null
HP
CN
null
228584963
22858496
3
F
20220101
20230913
20230824
20230918
PER
null
US-GILEAD-2023-0641112
GILEAD
null
57
YR
A
M
Y
null
null
20230918
null
LW
US
US
228584971
22858497
1
I
null
20230801
20230824
20230824
EXP
null
US-SANDOZ INC.-SDZ2023US017918
SANDOZ
null
null
null
null
M
Y
null
null
20230824
null
MD
US
US
228584981
22858498
1
I
20230601
20230816
20230824
20230824
EXP
null
US-GSK-US2023111990
GLAXOSMITHKLINE
null
68
YR
null
F
Y
null
null
20230824
null
CN
US
US
228584991
22858499
1
I
null
20230818
20230824
20230824
30DAY
null
US-GSK-US2023112758
GLAXOSMITHKLINE
null
null
null
null
F
Y
null
null
20230824
null
CN
US
US
228585002
22858500
2
F
null
20230824
20230824
20230912
30DAY
null
CO-JNJFOC-20230854798
JOHNSON AND JOHNSON
null
null
null
null
null
Y
null
null
20230910
null
CN
CO
CO
228585011
22858501
1
I
20230809
20230822
20230824
20230824
EXP
null
US-ABBVIE-5378574
ABBVIE
null
66
YR
null
F
Y
null
null
20230824
null
CN
US
US
228585021
22858502
1
I
20110101
20230508
20230824
20230824
EXP
null
US-ENDO PHARMACEUTICALS INC-2023-001958
ENDO
null
null
null
null
F
Y
null
null
20230824
null
CN
US
US
228585032
22858503
2
F
null
20230817
20230824
20230824
EXP
null
CO-002147023-NVSC2021CO192372
SANDOZ
null
null
null
null
F
Y
null
null
20230824
null
CN
CO
CO
228585051
22858505
1
I
20230601
20230817
20230824
20230824
PER
null
US-ABBVIE-5374423
ABBVIE
null
null
null
null
null
Y
null
null
20230824
null
MD
US
US
228585063
22858506
3
F
20230101
20230908
20230824
20230925
PER
null
US-AMGEN-USASP2023146606
AMGEN
null
69
YR
E
F
Y
null
null
20230924
null
CN
US
US
228585071
22858507
1
I
null
20230621
20230824
20230824
EXP
null
US-SANDOZ INC.-SDZ2023US017808
SANDOZ
null
null
null
null
F
Y
null
null
20230824
null
HP
US
US
228585081
22858508
1
I
null
20230816
20230824
20230824
EXP
null
CA-APOTEX-2023AP012434
APOTEX
null
29
YR
null
F
Y
null
null
20230824
null
HP
CA
CA
228585091
22858509
1
I
null
20230821
20230824
20230824
EXP
null
US-AstraZeneca-2023A192016
ASTRAZENECA
null
null
null
null
M
Y
null
null
20230824
null
CN
US
null
228585101
22858510
1
I
null
20230816
20230824
20230824
EXP
null
PA-002147023-NVSC2023PA099817
SANDOZ
null
null
null
null
F
Y
null
null
20230824
null
CN
PA
PA
228585111
22858511
1
I
null
20230817
20230824
20230824
EXP
null
US-AstraZeneca-2023A188493
ASTRAZENECA
null
null
null
null
F
Y
null
null
20230824
null
CN
US
null
228585121
22858512
1
I
null
20230508
20230824
20230824
EXP
null
US-ENDO PHARMACEUTICALS INC-2023-001959
ENDO
null
null
null
null
F
Y
null
null
20230824
null
CN
US
US
228585132
22858513
2
F
null
20230814
20230824
20230825
PER
null
NVSC2023US179126
NOVARTIS
null
61
YR
null
F
Y
null
null
20230825
null
CN
US
US
228585141
22858514
1
I
null
20230731
20230824
20230824
EXP
null
US-SANDOZ INC.-SDZ2023US017940
SANDOZ
null
null
null
null
F
Y
null
null
20230824
null
MD
US
US
228585151
22858515
1
I
20230701
20230817
20230824
20230824
EXP
null
US-JNJFOC-20230842535
JOHNSON AND JOHNSON
null
83
YR
E
F
Y
null
null
20230824
null
HP
US
US
228585161
22858516
1
I
null
20230728
20230824
20230824
EXP
null
US-SANDOZ INC.-SDZ2023US017775
SANDOZ
null
null
null
null
F
Y
76.82
KG
20230824
null
HP
US
US
228585171
22858517
1
I
null
20230821
20230824
20230824
PER
null
US-AMGEN-USASP2023149133
AMGEN
null
null
null
null
null
Y
null
null
20230824
null
CN
US
US
228585183
22858518
3
F
20230801
20230911
20230824
20230918
PER
null
US-AMGEN-USASP2023148930
AMGEN
null
52
YR
A
F
Y
null
null
20230917
null
HP
US
US
228585191
22858519
1
I
20230101
20230818
20230824
20230824
PER
null
US-UNITED THERAPEUTICS-UNT-2023-023046
UNITED THERAPEUTICS
null
null
null
null
M
Y
68.481
KG
20230824
null
CN
US
US
228585201
22858520
1
I
null
20230822
20230824
20230824
PER
null
US-AMGEN-USASP2023149393
AMGEN
null
null
null
null
null
Y
null
null
20230824
null
CN
US
US