bendamustine 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |

Stem definitionDrug idCAS RN
antineoplastic, alkylating agents, (beta-chloroethyl)amine derivatives 302 16506-27-7

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • bendamustine
  • bendamustine hydrochloride
  • treanda
  • bendamustine HCl
A nitrogen mustard compound that functions as an ALKYLATING ANTINEOPLASTIC AGENT and is used in the treatment of CHRONIC LYMPHOCYTIC LEUKEMIA and NON-HODGKIN'S LYMPHOMA.
  • Molecular weight: 358.26
  • Formula: C16H21Cl2N3O2
  • CLOGP: 3.24
  • LIPINSKI: 0
  • HAC: 5
  • HDO: 1
  • TPSA: 58.36
  • ALOGS: -3.76
  • ROTB: 9
  • Status: OFP
    • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

None

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 1 Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 1 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 6.26 µM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
Vd (Volume of distribution) 0.22 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 4.49 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.05 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 0.41 hours Lombardo F, Berellini G, Obach RS

Predicted pharmacokinetic/toxicological properties (PK-AZ):

PropertyDescriptionValueUnitConfidenceSimilarity
kinase-safety-class ACVR2B,AURKA,AXL,BRAF,BTK,CAMK2D,CDK5,CDK9,DYRK1B,EIF2AK3,ERBB2,GRK2,IKBKB,ITK,KDR,MAP2K6,MAPK10,MAPK7,MAPKAPK2,NTRK2,PDK1,PDK2,PDK4,PIK3CB,PRKDC,SIK2,STK33,SYK,TEK,TGFBR1 30
kinase-selectivity-class GRK2,MAP2K6 2
pfas-class PFAS structural alert (1 = True, 0 = False) 0

Approvals:

DateAgencyCompanyOrphan
Sept. 27, 2010 PMDA SymBio Pharmaceuticals Limited
March 20, 2008 FDA CEPHALON

FDA Adverse Event Reporting System (Female)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Disease progression 1599.79 18.53 823 26083 155792 90445749
Neutropenia 653.42 18.53 537 26369 224367 90377174
Progressive multifocal leukoencephalopathy 576.66 18.53 205 26701 15450 90586091
Diffuse large B-cell lymphoma recurrent 522.42 18.53 135 26771 3391 90598150
Blood lactate dehydrogenase increased 476.22 18.53 205 26701 25727 90575814
Febrile neutropenia 473.75 18.53 385 26521 157964 90443577
Pancytopenia 463.69 18.53 340 26566 119923 90481618
Off label use 397.08 18.53 950 25956 1101302 89500239
Cytomegalovirus infection 381.83 18.53 177 26729 26425 90575116
Lymphoma 378.76 18.53 145 26761 13446 90588095
Neutrophil count decreased 366.54 18.53 241 26665 71291 90530250
COVID-19 317.26 18.53 316 26590 168527 90433014
Thrombocytopenia 312.54 18.53 346 26560 208379 90393162
Myelosuppression 297.69 18.53 190 26716 53401 90548140
Platelet count decreased 288.50 18.53 273 26633 136696 90464845
Pyrexia 287.38 18.53 615 26291 659870 89941671
Lymphocyte count decreased 282.61 18.53 158 26748 34892 90566649
Cytopenia 259.40 18.53 119 26787 17330 90584211
Diffuse large B-cell lymphoma 218.71 18.53 86 26820 8559 90592982
Hypogammaglobulinaemia 204.49 18.53 87 26819 10587 90590954
Malignant neoplasm progression 202.33 18.53 201 26705 106669 90494872
Cytokine release syndrome 198.39 18.53 116 26790 27857 90573684
Therapy partial responder 176.64 18.53 99 26807 21944 90579597
COVID-19 pneumonia 174.45 18.53 92 26814 18085 90583456
Tumour lysis syndrome 146.98 18.53 70 26836 11082 90590459
White blood cell count decreased 146.00 18.53 212 26694 166897 90434644
Lymphopenia 139.22 18.53 86 26820 22795 90578746
Cytomegalovirus infection reactivation 137.66 18.53 60 26846 7740 90593801
Anaemia 126.48 18.53 305 26601 352497 90249044
Myelodysplastic syndrome 123.21 18.53 77 26829 20826 90580715
B-cell lymphoma recurrent 122.78 18.53 29 26877 495 90601046
Pneumocystis jirovecii pneumonia 118.36 18.53 76 26830 21540 90580001
Abdominal discomfort 117.08 18.53 6 26900 477322 90124219
JC virus infection 116.96 18.53 40 26866 2679 90598862
Diffuse large B-cell lymphoma refractory 116.12 18.53 36 26870 1764 90599777
Sepsis 113.99 18.53 197 26709 179617 90421924
CD4 lymphocytes decreased 112.83 18.53 34 26872 1513 90600028
Cytomegalovirus chorioretinitis 109.60 18.53 37 26869 2382 90599159
Pain 108.17 18.53 83 26823 996258 89605283
Mantle cell lymphoma recurrent 103.07 18.53 24 26882 384 90601157
Vasogenic cerebral oedema 96.88 18.53 29 26877 1261 90600280
Second primary malignancy 89.68 18.53 49 26857 10329 90591212
Agranulocytosis 83.71 18.53 75 26831 34927 90566614
Haematotoxicity 83.66 18.53 50 26856 12485 90589056
Bone marrow failure 82.97 18.53 72 26834 32149 90569392
Joint swelling 81.83 18.53 24 26882 503276 90098265
Swelling 80.06 18.53 14 26892 419044 90182497
Rash maculo-papular 79.25 18.53 78 26828 40855 90560686
Hypercalcaemia 79.19 18.53 72 26834 34168 90567373
Maternal exposure during pregnancy 78.34 18.53 8 26898 360055 90241486
Arthralgia 78.00 18.53 70 26836 778452 89823089
Hepatitis B 77.27 18.53 34 26872 4485 90597056
Cytomegalovirus test positive 74.55 18.53 31 26875 3560 90597981
Wound 73.64 18.53 4 26902 302976 90298565
Autoimmune haemolytic anaemia 73.06 18.53 35 26871 5610 90595931
Humoral immune defect 72.50 18.53 18 26888 382 90601159
Pemphigus 71.79 18.53 7 26899 326857 90274684
Lymphoma transformation 71.52 18.53 16 26890 212 90601329
Nasopharyngitis 70.72 18.53 17 26889 407087 90194454
Neoplasm progression 70.28 18.53 76 26830 44410 90557131
Aplasia pure red cell 69.65 18.53 33 26873 5161 90596380
Headache 69.41 18.53 93 26813 862653 89738888
Pneumonia 67.75 18.53 370 26536 637689 89963852
Dizziness 65.17 18.53 48 26858 589236 90012305
Leukopenia 64.62 18.53 111 26795 100599 90500942
Death 62.03 18.53 284 26622 456267 90145274
Neurological symptom 61.03 18.53 33 26873 6814 90594727
Weight increased 59.21 18.53 25 26881 417902 90183639
Pericarditis 58.75 18.53 6 26900 270145 90331396
Discomfort 57.37 18.53 7 26899 274328 90327213
Skin neoplasm excision 57.26 18.53 21 26885 1725 90599816
Disease recurrence 57.16 18.53 63 26843 37590 90563951
Chills 57.02 18.53 123 26783 131858 90469683
Lymphadenopathy 56.76 18.53 69 26837 45706 90555835
Vaccination failure 56.72 18.53 19 26887 1194 90600347
Asthma 56.42 18.53 4 26902 242156 90359385
Post-acute COVID-19 syndrome 56.35 18.53 19 26887 1218 90600323
Erythropoiesis abnormal 56.09 18.53 14 26892 304 90601237
Anxiety 55.65 18.53 12 26894 309760 90291781
Abdominal pain upper 55.63 18.53 15 26891 332659 90268882
Cytomegalovirus viraemia 55.19 18.53 32 26874 7554 90593987
Herpes zoster 53.87 18.53 99 26807 94545 90506996
Gait disturbance 53.61 18.53 7 26899 260489 90341052
Follicular lymphoma 53.18 18.53 14 26892 378 90601163
Product dose omission issue 53.01 18.53 11 26895 291676 90309865
Fatigue 52.63 18.53 172 26734 1153851 89447690
Psoriatic arthropathy 52.54 18.53 4 26902 228331 90373210
Helicobacter infection 52.13 18.53 4 26902 226846 90374695
Arthropathy 51.72 18.53 22 26884 366220 90235321
Haemolytic anaemia 51.68 18.53 36 26870 11661 90589880
Atrial fibrillation 51.52 18.53 119 26787 133492 90468049
Gastrointestinal fungal infection 51.51 18.53 14 26892 428 90601113
Toxic skin eruption 50.50 18.53 40 26866 15734 90585807
Condition aggravated 50.08 18.53 62 26844 595483 90006058
Wheezing 49.96 18.53 6 26900 238074 90363467
Blood cholesterol increased 49.75 18.53 3 26903 208009 90393532
Drug hypersensitivity 49.64 18.53 39 26867 463570 90137971
Apoptotic colonopathy 49.62 18.53 10 26896 77 90601464
Hypoaesthesia 49.19 18.53 16 26890 314194 90287347
Peripheral swelling 49.17 18.53 31 26875 413075 90188466
Neuropathy peripheral 48.49 18.53 118 26788 136852 90464689
Venoocclusive liver disease 48.22 18.53 27 26879 5966 90595575
Rheumatoid arthritis 47.76 18.53 24 26882 362590 90238951
Exposure during pregnancy 47.66 18.53 7 26899 238403 90363138
Coronavirus infection 47.54 18.53 26 26880 5489 90596052
Contraindicated product administered 47.20 18.53 18 26888 320121 90281420
Injury 46.73 18.53 3 26903 197346 90404195
Extravasation 46.51 18.53 21 26885 2943 90598598
Folliculitis 45.85 18.53 4 26902 204349 90397192
Blister 45.54 18.53 10 26896 254988 90346553
Drug interaction 45.21 18.53 13 26893 276440 90325101
Campylobacter infection 45.08 18.53 16 26890 1196 90600345
Aspergillus infection 44.78 18.53 32 26874 10791 90590750
Muscle spasms 44.74 18.53 10 26896 251873 90349668
Varicella zoster virus infection 44.07 18.53 22 26884 3855 90597686
Immune effector cell-associated neurotoxicity syndrome 43.75 18.53 25 26881 5743 90595798
Chronic lymphocytic leukaemia recurrent 43.54 18.53 12 26894 387 90601154
Cerebral aspergillosis 43.50 18.53 13 26893 562 90600979
Osteoarthritis 43.46 18.53 4 26902 195726 90405815
Bronchopulmonary aspergillosis 43.29 18.53 32 26874 11366 90590175
Synovitis 43.16 18.53 22 26884 329730 90271811
Serum sickness 42.94 18.53 21 26885 3521 90598020
Sinus polyp 42.85 18.53 12 26894 411 90601130
Neutropenic infection 42.28 18.53 17 26889 1792 90599749
Neoplasm skin 42.25 18.53 20 26886 3122 90598419
Acute myeloid leukaemia 41.19 18.53 40 26866 20600 90580941
Panniculitis 40.67 18.53 34 26872 14424 90587117
Mucosal inflammation 40.26 18.53 66 26840 57559 90543982
Product use in unapproved indication 39.70 18.53 201 26705 336035 90265506
Prescribed underdose 39.61 18.53 76 26830 74943 90526598
Clostridium difficile colitis 39.36 18.53 44 26862 26662 90574879
Cerebral toxoplasmosis 39.16 18.53 15 26891 1390 90600151
Contusion 38.94 18.53 13 26893 251203 90350338
Malaise 38.64 18.53 72 26834 585914 90015627
Impaired healing 38.31 18.53 11 26895 234188 90367353
Feeling abnormal 38.27 18.53 3 26903 167232 90434309
Plasma cell leukaemia 38.24 18.53 14 26892 1144 90600397
Cytomegalovirus enterocolitis 38.15 18.53 13 26893 861 90600680
Hepatitis B reactivation 37.79 18.53 20 26886 3954 90597587
Eastern Cooperative Oncology Group performance status worsened 37.78 18.53 16 26890 1923 90599618
Hypertensive cardiomyopathy 37.17 18.53 10 26896 294 90601247
Enterococcal sepsis 37.12 18.53 15 26891 1601 90599940
Pain in extremity 36.70 18.53 48 26858 450481 90151060
Nasal abscess 36.66 18.53 9 26897 182 90601359
Encephalitis cytomegalovirus 36.52 18.53 12 26894 710 90600831
Non-small cell lung cancer 35.97 18.53 20 26886 4361 90597180
Klebsiella sepsis 35.71 18.53 15 26891 1766 90599775
Adenocarcinoma of colon 35.11 18.53 17 26889 2789 90598752
Cytomegalovirus colitis 34.94 18.53 18 26888 3368 90598173
Fear of injection 34.82 18.53 25 26881 8490 90593051
Memory impairment 34.68 18.53 8 26898 197236 90404305
Fall 33.74 18.53 57 26849 481753 90119788
Gastrooesophageal reflux disease 32.97 18.53 5 26901 166332 90435209
Obliterative bronchiolitis 32.81 18.53 16 26890 2665 90598876
B-cell lymphoma refractory 32.74 18.53 7 26899 74 90601467
Depression 32.51 18.53 25 26881 300576 90300965
Therapy responder 31.68 18.53 9 26897 325 90601216
Basal cell carcinoma 31.51 18.53 44 26862 33345 90568196
Insomnia 30.95 18.53 32 26874 333442 90268099
Sinusitis 30.64 18.53 34 26872 343054 90258487
Musculoskeletal stiffness 30.40 18.53 26 26880 296506 90305035
Psoriasis 30.32 18.53 4 26902 147750 90453791
Splenic marginal zone lymphoma recurrent 30.12 18.53 5 26901 10 90601531
Febrile bone marrow aplasia 29.69 18.53 24 26882 9714 90591827
Lymphatic duct injury 29.57 18.53 6 26900 48 90601493
Hypertension 29.45 18.53 57 26849 457475 90144066
Acute kidney injury 29.43 18.53 179 26727 320208 90281333
Urinary tract infection bacterial 29.31 18.53 20 26886 6265 90595276
Blood pressure increased 29.20 18.53 11 26895 197206 90404335
Infusion site irritation 29.17 18.53 12 26894 1341 90600200
Enterococcal infection 29.15 18.53 24 26882 9967 90591574
Pneumonitis 28.73 18.53 49 26857 44121 90557420
Mucosal erosion 28.72 18.53 13 26893 1832 90599709
Inappropriate schedule of product administration 28.61 18.53 5 26901 149928 90451613
Acute febrile neutrophilic dermatosis 28.60 18.53 16 26890 3529 90598012
Leukaemia cutis 28.27 18.53 7 26899 147 90601394
Alopecia 28.26 18.53 66 26840 495005 90106536
Dry mouth 27.70 18.53 10 26896 184049 90417492
Gait inability 27.69 18.53 5 26901 146451 90455090
Hospitalisation 27.43 18.53 3 26903 128097 90473444
Febrile infection 27.30 18.53 13 26893 2056 90599485
Pneumonia fungal 27.29 18.53 20 26886 7011 90594530
Injection site pain 26.89 18.53 9 26897 173690 90427851
VIth nerve paresis 26.85 18.53 6 26900 79 90601462
Leukaemic lymphoma 26.51 18.53 6 26900 84 90601457
Therapeutic product effect decreased 26.47 18.53 26 26880 277545 90323996
Neutrophil count abnormal 26.34 18.53 16 26890 4112 90597429
Blood immunoglobulin G decreased 25.94 18.53 15 26891 3523 90598018
Kidney malrotation 25.75 18.53 5 26901 31 90601510
Platelet count abnormal 25.62 18.53 16 26890 4319 90597222
Blood disorder 25.47 18.53 20 26886 7770 90593771
Mantle cell lymphoma 25.39 18.53 9 26897 670 90600871
Renal failure 25.30 18.53 91 26815 130916 90470625
Plasma cell myeloma refractory 24.94 18.53 10 26896 1046 90600495
Hepatic enzyme increased 24.93 18.53 43 26863 360693 90240848
Hypoglossal nerve paresis 24.85 18.53 6 26900 113 90601428
Guillain-Barre syndrome 24.71 18.53 16 26890 4596 90596945
Pseudomembranous colitis 24.70 18.53 15 26891 3853 90597688
Listeria sepsis 24.68 18.53 9 26897 727 90600814
Hydronephrosis 24.68 18.53 24 26882 12378 90589163
Lower respiratory tract infection 24.46 18.53 23 26883 250636 90350905
Liver injury 24.45 18.53 10 26896 170557 90430984
Adverse drug reaction 24.33 18.53 3 26903 116698 90484843
Procalcitonin increased 24.28 18.53 11 26895 1553 90599988
Oral fungal infection 24.09 18.53 14 26892 3318 90598223
Fungal oesophagitis 24.07 18.53 9 26897 780 90600761
Drug eruption 23.98 18.53 40 26866 35367 90566174
Aspartate aminotransferase increased 23.84 18.53 76 26830 102861 90498680
High-grade B-cell lymphoma 23.82 18.53 5 26901 48 90601493
Organising pneumonia 23.75 18.53 19 26887 7578 90593963
Schistocytosis 23.73 18.53 5 26901 49 90601492
Splenic marginal zone lymphoma 23.37 18.53 5 26901 53 90601488
Chest pain 23.11 18.53 37 26869 319608 90281933
Musculoskeletal pain 23.03 18.53 11 26895 171240 90430301
Cardiac failure 22.82 18.53 78 26828 109418 90492123
Disseminated intravascular coagulation 22.78 18.53 30 26876 21508 90580033
Bacterial infection 22.28 18.53 31 26875 23413 90578128
Dysplasia 22.26 18.53 10 26896 1384 90600157
Amnesia 22.11 18.53 3 26903 108502 90493039
Ototoxicity 21.90 18.53 11 26895 1953 90599588
Granuloma skin 21.88 18.53 21 26885 10659 90590882
Aplasia 21.76 18.53 14 26892 3977 90597564
Disseminated mucormycosis 21.74 18.53 8 26898 663 90600878
Eosinophilia 21.73 18.53 34 26872 28499 90573042
Alopecia scarring 21.64 18.53 6 26900 198 90601343
Wound infection 21.54 18.53 3 26903 106399 90495142
Overdose 21.41 18.53 10 26896 157699 90443842
Extranodal marginal zone B-cell lymphoma (MALT type) recurrent 21.33 18.53 4 26902 20 90601521
Hemianopia 21.29 18.53 11 26895 2071 90599470
Pleural effusion 20.95 18.53 77 26829 111914 90489627
Infusion site phlebitis 20.76 18.53 5 26901 93 90601448
Polyneuropathy 20.55 18.53 27 26879 19314 90582227
Breath sounds abnormal 20.39 18.53 24 26882 15362 90586179
Colitis 20.35 18.53 56 26850 69886 90531655
Rosai-Dorfman syndrome 20.31 18.53 4 26902 27 90601514
Cryoglobulinaemia 20.28 18.53 8 26898 802 90600739
Sciatica 20.20 18.53 3 26903 101379 90500162
Varicella zoster oesophagitis 20.18 18.53 4 26902 28 90601513
Adverse event 20.17 18.53 5 26901 117413 90484128
Multiple organ dysfunction syndrome 20.16 18.53 55 26851 68281 90533260
Skin necrosis 20.13 18.53 25 26881 16916 90584625
Drug resistance 20.09 18.53 34 26872 30415 90571126
Urosepsis 20.06 18.53 28 26878 21204 90580337
Bone marrow disorder 19.98 18.53 12 26894 3020 90598521
Bone marrow infiltration 19.98 18.53 8 26898 834 90600707
Cystitis haemorrhagic 19.87 18.53 15 26891 5498 90596043
Paraneoplastic pemphigus 19.84 18.53 5 26901 113 90601428
Neuroendocrine carcinoma of the skin 19.83 18.53 8 26898 850 90600691
Meningitis enteroviral 19.82 18.53 4 26902 31 90601510
Hypoalbuminaemia 19.76 18.53 24 26882 15873 90585668
Road traffic accident 19.66 18.53 4 26902 107622 90493919
Granulocyte count decreased 19.60 18.53 11 26895 2441 90599100
Blood parathyroid hormone decreased 19.51 18.53 21 26885 12195 90589346
Dyspnoea 19.34 18.53 168 26738 880787 89720754
Hyperuricaemia 19.31 18.53 16 26890 6703 90594838
Borrelia infection 19.29 18.53 6 26900 297 90601244
Therapy non-responder 19.21 18.53 86 26820 136618 90464923
Clostridial sepsis 19.19 18.53 7 26899 566 90600975
Erythema 19.11 18.53 125 26781 229121 90372420
Oesophageal candidiasis 19.08 18.53 16 26890 6813 90594728
Erythema annulare 19.03 18.53 6 26900 311 90601230
Bacterial sepsis 19.02 18.53 14 26892 4941 90596600
Varicella zoster gastritis 18.91 18.53 4 26902 40 90601501
Immune reconstitution inflammatory syndrome 18.70 18.53 16 26890 7003 90594538
Respiratory failure 18.56 18.53 77 26829 118341 90483200

FDA Adverse Event Reporting System (Male)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Disease progression 1780.47 17.51 1270 37010 142386 42440669
Off label use 414.20 17.51 1380 36900 636955 41946100
COVID-19 411.35 17.51 513 37767 115435 42467620
Progressive multifocal leukoencephalopathy 379.33 17.51 192 38088 11344 42571711
Febrile neutropenia 368.87 17.51 624 37656 185079 42397976
Cytomegalovirus infection 366.52 17.51 272 38008 32034 42551021
Blood lactate dehydrogenase increased 335.51 17.51 237 38043 25844 42557211
Pyrexia 297.88 17.51 900 37380 393142 42189913
Diffuse large B-cell lymphoma recurrent 284.90 17.51 121 38159 4765 42578290
Lymphoma 282.04 17.51 170 38110 14151 42568904
Hypogammaglobulinaemia 270.59 17.51 155 38125 11736 42571319
Neutropenia 267.46 17.51 567 37713 198864 42384191
Lymphocyte count decreased 262.55 17.51 210 38070 27599 42555456
Neutrophil count decreased 254.52 17.51 299 37981 63116 42519939
Malignant neoplasm progression 244.14 17.51 386 37894 108014 42475041
Myelosuppression 231.22 17.51 230 38050 40231 42542824
Tumour lysis syndrome 222.99 17.51 174 38106 22057 42560998
Cytopenia 211.16 17.51 153 38127 17344 42565711
Cytokine release syndrome 211.08 17.51 229 38051 44298 42538757
Thrombocytopenia 202.64 17.51 494 37786 189785 42393270
COVID-19 pneumonia 195.05 17.51 159 38121 21454 42561601
Myelodysplastic syndrome 192.07 17.51 161 38119 22584 42560471
Cytomegalovirus chorioretinitis 185.19 17.51 88 38192 4523 42578532
Lymphadenopathy 164.07 17.51 175 38105 33190 42549865
Neoplasm progression 164.06 17.51 164 38116 28836 42554219
Pancytopenia 163.55 17.51 340 37940 117403 42465652
Cytomegalovirus infection reactivation 163.51 17.51 110 38170 11068 42571987
Neutropenic sepsis 126.66 17.51 109 38171 15837 42567218
Lymphoma transformation 124.43 17.51 37 38243 495 42582560
Drug interaction 123.41 17.51 43 38237 266956 42316099
Infusion related reaction 122.40 17.51 206 38074 60600 42522455
Hepatitis B reactivation 121.37 17.51 66 38214 4512 42578543
Product dose omission issue 114.03 17.51 6 38274 154359 42428696
Therapy partial responder 110.96 17.51 112 38168 19909 42563146
Haematotoxicity 103.70 17.51 83 38197 10902 42572153
Diffuse large B-cell lymphoma 103.54 17.51 78 38202 9376 42573679
Second primary malignancy 102.65 17.51 78 38202 9497 42573558
Platelet count decreased 101.50 17.51 314 37966 138267 42444788
Infection 100.44 17.51 273 38007 111795 42471260
B-cell lymphoma recurrent 99.18 17.51 35 38245 827 42582228
Immune effector cell-associated neurotoxicity syndrome 99.07 17.51 76 38204 9385 42573670
White blood cell count decreased 98.01 17.51 268 38012 110128 42472927
Septic shock 96.22 17.51 237 38043 91435 42491620
Humoral immune defect 92.08 17.51 27 38253 343 42582712
End stage renal disease 90.61 17.51 92 38188 16466 42566589
Arthralgia 89.83 17.51 36 38244 205202 42377853
Prescribed underdose 87.22 17.51 73 38207 10209 42572846
Product use in unapproved indication 86.35 17.51 361 37919 184095 42398960
Acute myeloid leukaemia 85.95 17.51 103 38177 22153 42560902
Pneumocystis jirovecii pneumonia 85.14 17.51 109 38171 25072 42557983
Toxicity to various agents 82.57 17.51 52 38228 229084 42353971
Mantle cell lymphoma recurrent 82.55 17.51 32 38248 991 42582064
Dizziness 80.06 17.51 64 38216 249190 42333865
Extravasation 79.17 17.51 40 38240 2350 42580705
Pneumonia 77.79 17.51 645 37635 421504 42161551
Headache 77.46 17.51 61 38219 239308 42343747
Chronic lymphocytic leukaemia recurrent 76.39 17.51 27 38253 641 42582414
Bone marrow failure 75.91 17.51 119 38161 32974 42550081
Autoimmune haemolytic anaemia 73.93 17.51 52 38228 5619 42577436
Somnolence 71.83 17.51 19 38261 141086 42441969
Cytomegalovirus enterocolitis 69.99 17.51 31 38249 1352 42581703
Pneumonia cytomegaloviral 68.60 17.51 44 38236 4082 42578973
Human polyomavirus infection 68.50 17.51 30 38250 1273 42581782
Anaemia 67.21 17.51 456 37824 279822 42303233
Hepatitis B 66.11 17.51 52 38228 6659 42576396
Pain 65.59 17.51 74 38206 244774 42338281
Pain in extremity 64.91 17.51 27 38253 150577 42432478
Cytomegalovirus test positive 64.34 17.51 43 38237 4276 42578779
Inappropriate schedule of product administration 64.23 17.51 6 38274 95896 42487159
Rash maculo-papular 63.71 17.51 118 38162 37385 42545670
CD4 lymphocytes decreased 63.19 17.51 32 38248 1889 42581166
Hypertension 61.51 17.51 37 38243 167167 42415888
Fall 60.53 17.51 73 38207 234447 42348608
Post-acute COVID-19 syndrome 58.93 17.51 20 38260 419 42582636
Chills 58.75 17.51 202 38078 93864 42489191
Insomnia 58.17 17.51 17 38263 118236 42464819
Bacteraemia 57.36 17.51 90 38190 24950 42558105
Overdose 55.84 17.51 13 38267 105251 42477804
Anxiety 54.84 17.51 19 38261 118541 42464514
Rhabdomyolysis 54.68 17.51 4 38276 78015 42505040
Condition aggravated 54.64 17.51 94 38186 260660 42322395
Follicular lymphoma 54.44 17.51 19 38261 434 42582621
Hepatitis E 53.54 17.51 34 38246 3100 42579955
Fatigue 51.02 17.51 210 38070 435431 42147624
Lymphopenia 50.08 17.51 78 38202 21485 42561570
Endocarditis noninfective 49.91 17.51 14 38266 150 42582905
Hepatitis viral 49.88 17.51 21 38259 808 42582247
Seizure 49.74 17.51 23 38257 120538 42462517
Cerebrovascular accident 49.58 17.51 13 38267 97147 42485908
Secondary immunodeficiency 49.23 17.51 21 38259 835 42582220
Basal cell carcinoma 48.35 17.51 79 38201 22654 42560401
Squamous cell carcinoma 48.35 17.51 59 38221 12923 42570132
Serum sickness 47.92 17.51 28 38252 2197 42580858
Sepsis 46.90 17.51 323 37957 199011 42384044
Hospitalisation 46.35 17.51 6 38274 74324 42508731
Primary amyloidosis 44.59 17.51 14 38266 227 42582828
Asthma 44.23 17.51 3 38277 62311 42520744
Neoplasm 43.88 17.51 40 38240 6265 42576790
Intentional product misuse 43.87 17.51 3 38277 61897 42521158
Neuropathy peripheral 43.46 17.51 194 38086 101659 42481396
Bronchopulmonary aspergillosis 43.34 17.51 69 38211 19360 42563695
Nausea 42.34 17.51 198 38082 396601 42186454
Herpes zoster 42.32 17.51 102 38178 38775 42544280
Enterococcal infection 42.08 17.51 53 38227 11986 42571069
Pneumonia pseudomonal 41.93 17.51 35 38245 4874 42578181
Therapy non-responder 41.88 17.51 124 38156 53235 42529820
Weight increased 40.96 17.51 23 38257 107960 42475095
Atypical pneumonia 40.90 17.51 32 38248 4065 42578990
Squamous cell carcinoma of skin 39.76 17.51 53 38227 12673 42570382
Cytomegalovirus colitis 39.54 17.51 31 38249 3950 42579105
Aplasia pure red cell 39.53 17.51 40 38240 7126 42575929
Muscle spasms 39.42 17.51 14 38266 86030 42497025
Peripheral swelling 39.17 17.51 16 38264 90254 42492801
Disease recurrence 39.12 17.51 84 38196 29594 42553461
Infusion site phlebitis 38.93 17.51 9 38271 40 42583015
Organising pneumonia 37.87 17.51 40 38240 7492 42575563
Depression 37.73 17.51 27 38253 111336 42471719
Gait disturbance 36.98 17.51 21 38259 97979 42485076
Oral fungal infection 36.82 17.51 22 38258 1799 42581256
Dermatitis exfoliative generalised 36.77 17.51 35 38245 5789 42577266
Infusion site extravasation 36.64 17.51 34 38246 5447 42577608
Marginal zone lymphoma recurrent 35.61 17.51 9 38271 62 42582993
Neoplasm recurrence 35.56 17.51 25 38255 2699 42580356
Musculoskeletal stiffness 35.21 17.51 5 38275 57760 42525295
Cytomegalovirus viraemia 35.19 17.51 45 38235 10332 42572723
Paraneoplastic pemphigus 34.89 17.51 9 38271 68 42582987
Hypoglycaemia 34.63 17.51 6 38274 59848 42523207
Chronic lymphocytic leukaemia 34.32 17.51 31 38249 4798 42578257
Coma 34.18 17.51 4 38276 53550 42529505
Agitation 33.98 17.51 8 38272 64306 42518749
Campylobacter infection 33.67 17.51 19 38261 1396 42581659
Fat tissue increased 33.47 17.51 14 38266 530 42582525
JC virus infection 33.36 17.51 25 38255 2979 42580076
Splenomegaly 33.26 17.51 57 38223 16990 42566065
Abdominal lymphadenopathy 33.12 17.51 17 38263 1032 42582023
Intentional product use issue 33.05 17.51 140 38140 71693 42511362
Pneumonia bacterial 32.65 17.51 54 38226 15638 42567417
Coronavirus infection 32.28 17.51 31 38249 5183 42577872
Blood pressure increased 31.63 17.51 27 38253 101901 42481154
Phlebitis 31.58 17.51 28 38252 4230 42578825
Hyponatraemia 31.34 17.51 27 38253 101435 42481620
Drug ineffective for unapproved indication 31.33 17.51 102 38178 46061 42536994
Ill-defined disorder 31.15 17.51 54 38226 16242 42566813
Pseudomonas infection 30.75 17.51 53 38227 15870 42567185
Immunoglobulins decreased 30.70 17.51 16 38264 1003 42582052
Suicide attempt 30.55 17.51 3 38277 46097 42536958
Cytomegalovirus syndrome 30.36 17.51 9 38271 119 42582936
Gastrointestinal haemorrhage 30.19 17.51 26 38254 97700 42485355
Procalcitonin increased 29.97 17.51 21 38259 2255 42580800
Suicidal ideation 29.75 17.51 4 38276 48157 42534898
Malaise 29.54 17.51 95 38185 212061 42370994
Hypersensitivity 29.47 17.51 136 38144 72234 42510821
Cell-mediated cytotoxicity 29.44 17.51 7 38273 36 42583019
Urethral obstruction 29.22 17.51 10 38270 215 42582840
Stress 28.98 17.51 3 38277 44209 42538846
Aggression 28.94 17.51 3 38277 44160 42538895
Peripheral T-cell lymphoma unspecified 28.80 17.51 13 38267 593 42582462
Cardiac failure congestive 28.67 17.51 21 38259 85581 42497474
Blood bilirubin decreased 28.60 17.51 13 38267 603 42582452
Fungal infection 28.53 17.51 58 38222 19664 42563391
Candida pneumonia 28.53 17.51 14 38266 772 42582283
Aplasia 28.50 17.51 28 38252 4815 42578240
Constipation 28.35 17.51 65 38215 162226 42420829
Polyneuropathy 28.34 17.51 56 38224 18605 42564450
Metastases to muscle 28.15 17.51 10 38270 241 42582814
Myalgia 27.97 17.51 27 38253 96053 42487002
Leukopenia 27.92 17.51 137 38143 74609 42508446
Rash 27.89 17.51 375 37905 276579 42306476
Vision blurred 27.74 17.51 7 38273 53692 42529363
Cystitis viral 27.73 17.51 16 38264 1226 42581829
Feeling abnormal 27.72 17.51 14 38266 69772 42513283
Haematochezia 27.64 17.51 9 38271 58427 42524628
Abdominal distension 27.60 17.51 15 38265 71720 42511335
International normalised ratio increased 27.49 17.51 5 38275 48163 42534892
Metastases to retroperitoneum 27.37 17.51 10 38270 262 42582793
Bradycardia 27.32 17.51 22 38258 85462 42497593
Oedema peripheral 26.71 17.51 51 38229 136025 42447030
Neuroendocrine carcinoma of the skin 25.93 17.51 14 38266 943 42582112
Malignant pleural effusion 25.65 17.51 18 38262 1937 42581118
Blood creatine phosphokinase increased 25.56 17.51 6 38274 48332 42534723
Dry skin 25.56 17.51 6 38274 48332 42534723
Injection site phlebitis 25.54 17.51 6 38274 29 42583026
Lactic acidosis 25.19 17.51 5 38275 45256 42537799
Dermatitis exfoliative 24.94 17.51 31 38249 6916 42576139
Product use issue 24.73 17.51 135 38145 76616 42506439
B-cell lymphoma 24.53 17.51 26 38254 4887 42578168
Chest pain 24.27 17.51 56 38224 139474 42443581
Nephrogenic diabetes insipidus 24.24 17.51 16 38264 1558 42581497
Cytomegalovirus hepatitis 23.96 17.51 11 38269 522 42582533
Agranulocytosis 23.88 17.51 71 38209 30541 42552514
Blood stem cell harvest failure 23.78 17.51 6 38274 41 42583014
Metastases to bone marrow 23.59 17.51 11 38269 541 42582514
Vomiting 23.52 17.51 158 38122 289565 42293490
Blood glucose increased 23.51 17.51 19 38261 73680 42509375
Sphingomonas paucimobilis infection 23.18 17.51 6 38274 46 42583009
Balance disorder 23.14 17.51 7 38273 47638 42535417
Gastroenteritis sapovirus 23.08 17.51 8 38272 179 42582876
Gastrooesophageal reflux disease 23.01 17.51 6 38274 45017 42538038
Opportunistic infection 23.00 17.51 17 38263 1984 42581071
Rheumatoid arthritis 22.98 17.51 5 38275 42435 42540620
Epistaxis 22.89 17.51 16 38264 66810 42516245
Rectal haemorrhage 22.83 17.51 8 38272 49598 42533457
Cytomegalovirus gastritis 22.73 17.51 9 38271 295 42582760
Ureteric compression 22.53 17.51 9 38271 302 42582753
Cerebral aspergillosis 22.48 17.51 16 38264 1761 42581294
Abdominal neoplasm 22.28 17.51 10 38270 450 42582605
Haemophagocytic lymphohistiocytosis 22.22 17.51 50 38230 18172 42564883
Hallucination 22.16 17.51 12 38268 57495 42525560
Haemoptysis 22.03 17.51 7 38273 46160 42536895
Myositis 21.84 17.51 44 38236 14822 42568233
Dyspnoea 21.77 17.51 274 38006 442347 42140708
Retinitis 21.62 17.51 10 38270 483 42582572
Cardio-respiratory arrest 21.50 17.51 13 38267 58623 42524432
Babesiosis 21.39 17.51 8 38272 224 42582831
Metastases to spleen 21.31 17.51 10 38270 499 42582556
Haemolysis 21.31 17.51 34 38246 9555 42573500
Hyperleukocytosis 21.05 17.51 18 38262 2590 42580465
Diffuse large B-cell lymphoma refractory 20.81 17.51 16 38264 1981 42581074
Arthritis 20.75 17.51 6 38274 42059 42540996
Ototoxicity 20.74 17.51 17 38263 2308 42580747
Contusion 20.69 17.51 6 38274 41979 42541076
Lymphoplasmacytoid lymphoma/immunocytoma recurrent 20.67 17.51 5 38275 28 42583027
Myocardial infarction 20.59 17.51 51 38229 123958 42459097
Psoriasis 20.46 17.51 9 38271 48595 42534460
Infusion site irritation 20.44 17.51 9 38271 387 42582668
Heart rate decreased 20.40 17.51 4 38276 36528 42546527
Ilium fracture 20.18 17.51 7 38273 157 42582898
Mantle cell lymphoma 20.12 17.51 14 38266 1486 42581569
Sleep disorder 20.10 17.51 9 38271 48086 42534969
Adenocarcinoma 20.07 17.51 16 38264 2088 42580967
Skin toxicity 20.03 17.51 27 38253 6522 42576533
Diabetes mellitus 19.78 17.51 15 38265 60072 42522983
Loss of personal independence in daily activities 19.77 17.51 10 38270 49806 42533249
Abdominal pain 19.68 17.51 96 38184 190375 42392680
Candida infection 19.67 17.51 53 38227 21557 42561498
Loss of consciousness 19.56 17.51 33 38247 92321 42490734
Inflammatory marker increased 19.38 17.51 27 38253 6729 42576326
Back pain 19.36 17.51 64 38216 141712 42441343
Drug resistance 19.17 17.51 71 38209 34177 42548878
Blood immunoglobulin M abnormal 19.13 17.51 6 38274 97 42582958
Dry mouth 19.11 17.51 6 38274 39873 42543182
Incorrect dose administered 19.07 17.51 12 38268 52962 42530093
Glomerular filtration rate decreased 18.98 17.51 44 38236 16307 42566748
Blood immunoglobulin G abnormal 18.96 17.51 6 38274 100 42582955
Wheezing 18.92 17.51 13 38267 54768 42528287
Pneumonia escherichia 18.60 17.51 10 38270 668 42582387
Blood pressure decreased 18.38 17.51 102 38178 58230 42524825
Metabolic acidosis 18.32 17.51 12 38268 51846 42531209
Injection site pain 18.31 17.51 15 38265 57783 42525272
Acquired C1 inhibitor deficiency 18.29 17.51 4 38276 13 42583042
Toxic skin eruption 18.25 17.51 39 38241 13691 42569364
Chylothorax 18.24 17.51 12 38268 1162 42581893
Visual impairment 18.12 17.51 8 38272 43105 42539950
Weight decreased 18.09 17.51 111 38169 207837 42375218
Vaccination failure 18.04 17.51 13 38267 1459 42581596
Type IV hypersensitivity reaction 18.02 17.51 16 38264 2421 42580634
Musculoskeletal pain 17.90 17.51 4 38276 33336 42549719
Guillain-Barre syndrome 17.88 17.51 27 38253 7236 42575819
B-cell small lymphocytic lymphoma recurrent 17.85 17.51 4 38276 15 42583040
Stevens-Johnson syndrome 17.83 17.51 52 38228 22126 42560929
Renal tubular necrosis 17.70 17.51 46 38234 18308 42564747
Hypoaesthesia 17.60 17.51 23 38257 71440 42511615
Muscular weakness 17.53 17.51 30 38250 83468 42499587

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Disease progression 2376.09 16.86 1496 54467 242538 110290798
COVID-19 868.72 16.86 826 55137 244234 110289102
Progressive multifocal leukoencephalopathy 839.67 16.86 354 55609 24602 110508734
Off label use 720.53 16.86 2010 53953 1498175 109035161
Febrile neutropenia 719.14 16.86 842 55121 315925 110217411
Diffuse large B-cell lymphoma recurrent 706.70 16.86 218 55745 6081 110527255
Neutropenia 695.97 16.86 900 55063 373720 110159616
Cytomegalovirus infection 690.93 16.86 397 55566 54047 110479289
Blood lactate dehydrogenase increased 569.73 16.86 326 55637 44008 110489328
Pyrexia 507.99 16.86 1282 54681 896983 109636353
Myelosuppression 503.40 16.86 402 55561 93938 110439398
Neutrophil count decreased 474.67 16.86 432 55531 120509 110412827
Cytokine release syndrome 470.66 16.86 343 55620 69963 110463373
Hypogammaglobulinaemia 467.11 16.86 220 55743 19856 110513480
Thrombocytopenia 457.19 16.86 710 55253 348175 110185161
Cytopenia 451.16 16.86 245 55718 29871 110503465
Malignant neoplasm progression 442.71 16.86 492 55471 174075 110359261
Pancytopenia 419.05 16.86 523 55440 209090 110324246
COVID-19 pneumonia 403.32 16.86 245 55718 36898 110496438
Lymphocyte count decreased 366.68 16.86 272 55691 56971 110476365
Tumour lysis syndrome 328.83 16.86 201 55762 30600 110502736
Myelodysplastic syndrome 321.45 16.86 213 55750 37271 110496065
Cytomegalovirus infection reactivation 313.68 16.86 163 55800 18170 110515166
Lymphoma 307.38 16.86 166 55797 20005 110513331
Platelet count decreased 298.66 16.86 467 55496 229976 110303360
Cytomegalovirus chorioretinitis 286.85 16.86 115 55848 7013 110526323
Therapy partial responder 264.35 16.86 188 55775 36873 110496463
Diffuse large B-cell lymphoma 251.10 16.86 134 55829 15764 110517572
Pain 195.88 16.86 121 55842 954834 109578502
Second primary malignancy 193.06 16.86 118 55845 17950 110515386
Pneumonia 192.28 16.86 914 55049 875800 109657536
Pneumocystis jirovecii pneumonia 192.10 16.86 165 55798 42570 110490766
Neoplasm progression 189.78 16.86 197 55766 64398 110468938
Lymphoma transformation 174.98 16.86 44 55919 560 110532776
White blood cell count decreased 168.63 16.86 364 55599 229026 110304310
Arthralgia 167.95 16.86 93 55870 779539 109753797
Haematotoxicity 166.82 16.86 114 55849 20968 110512368
Sepsis 166.09 16.86 450 55513 326896 110206440
Hepatitis B reactivation 164.83 16.86 79 55884 7405 110525931
Immune effector cell-associated neurotoxicity syndrome 164.26 16.86 99 55864 14683 110518653
CD4 lymphocytes decreased 162.67 16.86 60 55903 2914 110530422
Lymphopenia 162.33 16.86 146 55817 40024 110493312
Anaemia 161.04 16.86 624 55339 546462 109986874
B-cell lymphoma recurrent 159.68 16.86 47 55916 1111 110532225
Lymphadenopathy 156.56 16.86 177 55786 63658 110469678
Humoral immune defect 151.21 16.86 41 55922 712 110532624
Septic shock 149.33 16.86 278 55685 157250 110376086
Mantle cell lymphoma recurrent 147.45 16.86 43 55920 983 110532353
Headache 147.33 16.86 138 55825 882239 109651097
Joint swelling 146.84 16.86 24 55939 442821 110090515
Product use in unapproved indication 145.48 16.86 527 55436 446850 110086486
Dizziness 143.63 16.86 88 55875 698105 109835231
Cytomegalovirus test positive 142.10 16.86 70 55893 6966 110526370
Acute myeloid leukaemia 139.37 16.86 131 55832 37979 110495357
Autoimmune haemolytic anaemia 139.13 16.86 79 55884 10488 110522848
JC virus infection 132.41 16.86 61 55902 5229 110528107
Rash maculo-papular 128.96 16.86 173 55790 74049 110459287
Bone marrow failure 126.14 16.86 151 55812 57697 110475639
Drug interaction 120.78 16.86 51 55912 500132 110033204
Product dose omission issue 114.68 16.86 14 55949 321768 110211568
End stage renal disease 111.20 16.86 90 55873 21383 110511953
Neuropathy peripheral 111.13 16.86 266 55697 179011 110354325
Swelling 107.84 16.86 23 55940 351018 110182318
Cytomegalovirus enterocolitis 106.54 16.86 41 55922 2240 110531096
Abdominal discomfort 105.43 16.86 34 55929 393824 110139512
Maternal exposure during pregnancy 104.71 16.86 6 55957 254877 110278459
Pain in extremity 103.46 16.86 59 55904 487059 110046277
Asthma 102.49 16.86 6 55957 250285 110283051
Post-acute COVID-19 syndrome 101.98 16.86 36 55927 1539 110531797
Prescribed underdose 101.33 16.86 144 55819 65030 110468306
Chills 100.57 16.86 266 55697 190314 110343022
Serum sickness 98.52 16.86 47 55916 4359 110528977
Bronchopulmonary aspergillosis 98.52 16.86 97 55866 29766 110503570
Aplasia pure red cell 98.36 16.86 61 55902 9517 110523819
Weight increased 97.79 16.86 45 55918 419599 110113737
Anxiety 97.42 16.86 27 55936 345051 110188285
Agranulocytosis 96.82 16.86 137 55826 61623 110471713
Neutropenic sepsis 96.14 16.86 97 55866 30649 110502687
Chronic lymphocytic leukaemia recurrent 95.63 16.86 31 55932 1018 110532318
Nasopharyngitis 95.50 16.86 40 55923 394321 110139015
Wound 94.84 16.86 6 55957 234431 110298905
Basal cell carcinoma 93.53 16.86 115 55848 45155 110488181
Follicular lymphoma 92.63 16.86 28 55935 727 110532609
Peripheral swelling 91.57 16.86 45 55918 403989 110129347
Fall 89.72 16.86 104 55859 603378 109929958
Fatigue 89.55 16.86 316 55647 1215642 109317694
Hypertension 89.50 16.86 76 55887 510008 110023328
Muscle spasms 87.96 16.86 17 55946 278140 110255196
Wheezing 86.43 16.86 13 55950 255217 110278119
Human polyomavirus infection 86.35 16.86 33 55930 1769 110531567
Psoriatic arthropathy 86.15 16.86 3 55960 196758 110336578
Hepatitis B 85.72 16.86 56 55907 9556 110523780
Diffuse large B-cell lymphoma refractory 85.53 16.86 36 55927 2485 110530851
Condition aggravated 84.31 16.86 152 55811 734684 109798652
Mobility decreased 82.95 16.86 11 55952 237411 110295925
Enterococcal infection 82.22 16.86 74 55889 20292 110513044
Leukopenia 81.88 16.86 211 55752 148580 110384756
Abdominal pain upper 80.44 16.86 38 55925 349073 110184263
Blood cholesterol increased 80.26 16.86 3 55960 184782 110348554
Pemphigus 79.81 16.86 8 55955 214562 110318774
Cytomegalovirus viraemia 78.62 16.86 68 55895 17696 110515640
Rheumatoid arthritis 78.17 16.86 27 55936 299586 110233750
Malaise 77.92 16.86 138 55825 671681 109861655
Cytomegalovirus colitis 77.70 16.86 47 55916 7014 110526322
Insomnia 77.50 16.86 43 55920 360547 110172789
Pericarditis 76.91 16.86 10 55953 219104 110314232
Drug hypersensitivity 76.81 16.86 70 55893 454020 110079316
Contusion 76.51 16.86 13 55950 233348 110299988
Helicobacter infection 75.56 16.86 4 55959 181873 110351463
Bacteraemia 75.45 16.86 100 55863 42290 110491046
Arthropathy 74.85 16.86 26 55937 287496 110245840
Synovitis 74.50 16.86 23 55940 274069 110259267
Gait disturbance 74.45 16.86 24 55939 278184 110255152
Campylobacter infection 74.18 16.86 32 55931 2347 110530989
Coronavirus infection 74.05 16.86 51 55912 9494 110523842
Duodenal ulcer perforation 73.54 16.86 4 55959 177696 110355640
Injury 73.33 16.86 4 55959 177261 110356075
Pneumonia cytomegaloviral 73.22 16.86 45 55918 6909 110526427
Death 72.97 16.86 603 55360 698266 109835070
Osteoarthritis 72.90 16.86 5 55958 182618 110350718
Vaccination failure 72.58 16.86 32 55931 2474 110530862
Organising pneumonia 72.27 16.86 59 55904 14184 110519152
Gastrooesophageal reflux disease 71.63 16.86 5 55958 179971 110353365
Contraindicated product administered 70.85 16.86 19 55944 248248 110285088
Infection 70.70 16.86 366 55597 361834 110171502
Herpes zoster 70.59 16.86 164 55799 108215 110425121
Sleep disorder 69.88 16.86 9 55954 198635 110334701
Inappropriate schedule of product administration 69.80 16.86 10 55953 203627 110329709
Hypoaesthesia 69.67 16.86 36 55927 314187 110219149
Vasogenic cerebral oedema 69.19 16.86 30 55933 2228 110531108
Oral fungal infection 68.82 16.86 37 55926 4415 110528921
Depression 67.95 16.86 38 55925 317297 110216039
Impaired healing 66.64 16.86 10 55953 196707 110336629
Discomfort 66.04 16.86 14 55949 214693 110318643
Cerebral aspergillosis 65.40 16.86 29 55934 2273 110531063
Blister 63.76 16.86 18 55945 227358 110305978
Hypercalcaemia 63.72 16.86 97 55866 46560 110486776
Musculoskeletal stiffness 63.62 16.86 31 55932 279791 110253545
Hepatitis E 63.22 16.86 35 55928 4424 110528912
Pneumonia pseudomonal 62.54 16.86 42 55921 7504 110525832
Somnolence 61.72 16.86 37 55926 297412 110235924
Overdose 61.09 16.86 21 55942 233773 110299563
Aspergillus infection 61.04 16.86 70 55893 25546 110507790
Neoplasm 60.66 16.86 48 55915 11039 110522297
Exposure during pregnancy 60.32 16.86 7 55956 167417 110365919
Toxic skin eruption 60.26 16.86 72 55891 27443 110505893
Disease recurrence 59.72 16.86 109 55854 60675 110472661
Atrial fibrillation 59.43 16.86 252 55711 229390 110303946
Varicella zoster virus infection 59.00 16.86 38 55925 6330 110527006
Erythropoiesis abnormal 58.55 16.86 19 55944 626 110532710
Splenomegaly 58.47 16.86 67 55896 24431 110508905
Pneumonia bacterial 57.97 16.86 69 55894 26192 110507144
Type 2 diabetes mellitus 57.81 16.86 10 55953 177222 110356114
Dry mouth 57.62 16.86 15 55948 199933 110333403
Gait inability 56.64 16.86 3 55960 136373 110396963
Memory impairment 56.32 16.86 15 55948 196929 110336407
Aplasia 56.26 16.86 40 55923 7833 110525503
Procalcitonin increased 55.22 16.86 31 55932 4025 110529311
Feeling abnormal 55.13 16.86 12 55951 180699 110352637
Dermatitis exfoliative generalised 54.73 16.86 45 55918 10927 110522409
Musculoskeletal pain 54.15 16.86 13 55950 183010 110350326
Blood pressure increased 53.79 16.86 32 55931 258341 110274995
Squamous cell carcinoma 53.64 16.86 56 55907 18407 110514929
Hepatic enzyme increased 53.60 16.86 50 55913 320842 110212494
Alopecia 52.92 16.86 64 55899 364689 110168647
Folliculitis 51.42 16.86 11 55952 167642 110365694
Nausea 50.74 16.86 392 55571 1235298 109298038
Neoplasm recurrence 50.40 16.86 32 55931 5200 110528136
Dyspnoea 50.33 16.86 341 55622 1106531 109426805
Hepatitis viral 49.83 16.86 21 55942 1454 110531882
Neuroendocrine carcinoma of the skin 49.63 16.86 22 55941 1723 110531613
Endocarditis noninfective 49.26 16.86 14 55949 291 110533045
Intentional overdose 49.11 16.86 5 55958 132496 110400840
Primary amyloidosis 48.86 16.86 14 55949 300 110533036
Eosinophilia 48.42 16.86 97 55866 57839 110475497
Infusion related reaction 48.11 16.86 344 55619 380818 110152518
Squamous cell carcinoma of skin 47.88 16.86 51 55912 17152 110516184
Encephalitis cytomegalovirus 47.72 16.86 22 55941 1888 110531448
Drug ineffective for unapproved indication 47.72 16.86 137 55826 102701 110430635
Pseudomonas infection 46.95 16.86 64 55899 27789 110505547
Intentional product misuse 46.79 16.86 6 55957 132898 110400438
Hospitalisation 46.56 16.86 8 55955 142485 110390851
Skin neoplasm excision 46.16 16.86 22 55941 2036 110531300
Rhabdomyolysis 46.06 16.86 4 55959 120397 110412939
Chest pain 45.68 16.86 75 55888 376300 110157036
Psoriasis 45.43 16.86 8 55955 139985 110393351
Pleural effusion 45.18 16.86 194 55769 177515 110355821
Atypical pneumonia 45.09 16.86 35 55928 7827 110525509
Injection site pain 44.75 16.86 17 55946 177905 110355431
Therapeutic product effect decreased 44.54 16.86 35 55928 244281 110289055
Drug resistance 44.29 16.86 92 55871 56282 110477054
Chronic lymphocytic leukaemia 44.22 16.86 31 55932 5937 110527399
Toxicity to various agents 43.73 16.86 113 55850 480442 110052894
Dyspepsia 43.63 16.86 21 55942 190944 110342392
Cystitis viral 43.28 16.86 19 55944 1454 110531882
Blood lactate dehydrogenase abnormal 42.56 16.86 15 55948 638 110532698
Abdominal lymphadenopathy 42.40 16.86 20 55943 1808 110531528
Neutropenic infection 42.02 16.86 24 55939 3221 110530115
Medication error 41.71 16.86 3 55960 105363 110427973
Stress 41.70 16.86 3 55960 105345 110427991
Joint range of motion decreased 41.70 16.86 6 55957 121826 110411510
Haemolytic anaemia 41.37 16.86 52 55911 20868 110512468
Secondary immunodeficiency 41.10 16.86 27 55936 4649 110528687
Hyperleukocytosis 40.72 16.86 24 55939 3415 110529921
Colitis 40.59 16.86 129 55834 102194 110431142
Plasmacytoma 40.55 16.86 28 55935 5234 110528102
Hydronephrosis 40.28 16.86 51 55912 20614 110512722
Pneumonia fungal 39.76 16.86 43 55920 14711 110518625
Candida infection 39.66 16.86 80 55883 47929 110485407
Blood stem cell harvest failure 39.57 16.86 10 55953 130 110533206
Dermatitis exfoliative 39.56 16.86 38 55925 11309 110522027
Guillain-Barre syndrome 39.40 16.86 37 55926 10707 110522629
Balance disorder 39.30 16.86 6 55957 116554 110416782
Hypoglycaemia 39.09 16.86 6 55957 116098 110417238
Leukaemia cutis 38.47 16.86 11 55952 234 110533102
Extravasation 37.85 16.86 26 55937 4819 110528517
Acute kidney injury 37.79 16.86 489 55474 634941 109898395
Mantle cell lymphoma 37.68 16.86 18 55945 1674 110531662
Seizure 37.47 16.86 34 55929 221151 110312185
Febrile bone marrow aplasia 37.09 16.86 45 55918 17420 110515916
Haemophagocytic lymphohistiocytosis 36.74 16.86 61 55902 31498 110501838
Pneumonitis 36.52 16.86 103 55860 76428 110456908
Blood disorder 36.39 16.86 34 55929 9776 110523560
Gastrointestinal fungal infection 36.38 16.86 14 55949 765 110532571
Paraneoplastic pemphigus 36.23 16.86 10 55953 186 110533150
Apoptotic colonopathy 35.60 16.86 10 55953 199 110533137
Vision blurred 34.73 16.86 11 55952 129011 110404325
Immunoglobulins decreased 34.48 16.86 19 55944 2380 110530956
Neurological symptom 34.43 16.86 41 55922 15567 110517769
Neoplasm skin 34.41 16.86 21 55942 3183 110530153
Cytomegalovirus hepatitis 34.33 16.86 14 55949 892 110532444
Sinusitis 34.27 16.86 61 55902 296627 110236709
Amnesia 34.25 16.86 6 55957 105402 110427934
Plasma cell leukaemia 34.10 16.86 18 55945 2070 110531266
Neck pain 34.04 16.86 10 55953 123120 110410216
Back pain 33.92 16.86 87 55876 370909 110162427
Suicidal ideation 33.65 16.86 4 55959 93933 110439403
Nasal congestion 33.27 16.86 5 55958 98277 110435059
Blood immunoglobulin G decreased 33.08 16.86 25 55938 5375 110527961
Road traffic accident 33.02 16.86 7 55956 107391 110425945
Therapy non-responder 32.77 16.86 162 55801 157145 110376191
Clostridium difficile colitis 32.71 16.86 70 55893 43708 110489628
Campylobacter gastroenteritis 32.55 16.86 17 55946 1912 110531424
Wound infection 32.44 16.86 5 55958 96460 110436876
Marginal zone lymphoma recurrent 32.39 16.86 7 55956 43 110533293
Drug intolerance 32.26 16.86 102 55861 406410 110126926
Cerebral toxoplasmosis 32.23 16.86 20 55943 3122 110530214
Adverse drug reaction 32.21 16.86 7 55956 105552 110427784
Fungal infection 32.11 16.86 76 55887 50730 110482606
Abdominal distension 32.01 16.86 25 55938 175078 110358258
Venoocclusive liver disease 32.00 16.86 39 55924 15168 110518168
Visual impairment 31.92 16.86 14 55949 134414 110398922
Urethral obstruction 31.84 16.86 10 55953 296 110533040
Fat tissue increased 31.61 16.86 14 55949 1094 110532242
Lymphatic duct injury 31.60 16.86 7 55956 49 110533287
Nasal abscess 31.45 16.86 9 55954 192 110533144
Bone marrow disorder 31.44 16.86 22 55941 4201 110529135
Panniculitis 31.24 16.86 39 55924 15543 110517793
B-cell small lymphocytic lymphoma recurrent 31.23 16.86 6 55957 18 110533318
Skin toxicity 31.16 16.86 34 55929 11749 110521587
Peripheral T-cell lymphoma unspecified 31.15 16.86 13 55950 878 110532458
Sinus polyp 31.12 16.86 12 55951 659 110532677
Rectal haemorrhage 30.89 16.86 11 55952 119822 110413514
Haematochezia 30.82 16.86 10 55953 115514 110417822
Sciatica 30.60 16.86 5 55958 92394 110440942
Acute febrile neutrophilic dermatosis 30.56 16.86 23 55940 4913 110528423
Cerebrovascular accident 30.55 16.86 28 55935 181256 110352080
Dysplasia 30.37 16.86 16 55947 1832 110531504
Confusional state 30.33 16.86 128 55835 468552 110064784
Pneumonia escherichia 30.27 16.86 14 55949 1210 110532126
Coma 30.07 16.86 11 55952 117858 110415478
Metastases to meninges 29.78 16.86 23 55940 5105 110528231
Metastases to muscle 29.58 16.86 10 55953 375 110532961
Venoocclusive disease 29.51 16.86 25 55938 6325 110527011
Cell-mediated cytotoxicity 29.47 16.86 7 55956 69 110533267
Drug eruption 29.40 16.86 76 55887 53583 110479753
Fluid retention 29.30 16.86 6 55957 94301 110439035
Candida pneumonia 29.18 16.86 13 55950 1030 110532306
B-cell lymphoma 28.89 16.86 26 55937 7128 110526208
Gastrointestinal disorder 28.61 16.86 49 55914 241903 110291433
Metastases to retroperitoneum 28.54 16.86 10 55953 418 110532918
Lymphoplasmacytoid lymphoma/immunocytoma recurrent 28.32 16.86 6 55957 33 110533303
Agitation 28.09 16.86 11 55952 113040 110420296
Therapy responder 28.01 16.86 10 55953 442 110532894
Splenic marginal zone lymphoma 27.99 16.86 7 55956 87 110533249
Haemolysis 27.99 16.86 37 55926 15602 110517734
Interstitial lung disease 27.97 16.86 142 55821 139192 110394144
Oedema peripheral 27.83 16.86 80 55883 328580 110204756
Hyponatraemia 27.69 16.86 42 55921 217611 110315725
Lower limb fracture 27.51 16.86 3 55960 75345 110457991
Ureteric compression 27.49 16.86 9 55954 305 110533031
Ototoxicity 27.26 16.86 20 55943 4111 110529225
Cytomegalovirus syndrome 27.24 16.86 9 55954 314 110533022
JC polyomavirus test positive 26.80 16.86 16 55947 2331 110531005
Obliterative bronchiolitis 26.80 16.86 19 55944 3704 110529632
Adenocarcinoma 26.63 16.86 20 55943 4260 110529076
Erysipelas 26.49 16.86 33 55930 13125 110520211
Metastases to bone marrow 26.34 16.86 12 55951 1002 110532334
Prescribed overdose 26.34 16.86 6 55957 87575 110445761
Nephrogenic diabetes insipidus 26.19 16.86 16 55947 2429 110530907
Vomiting 26.18 16.86 315 55648 910360 109622976
Polyneuropathy 26.03 16.86 53 55910 31959 110501377
Gastroenteritis sapovirus 26.03 16.86 8 55955 220 110533116
H1N1 influenza 25.50 16.86 17 55946 3001 110530335
Lower respiratory tract infection 25.44 16.86 53 55910 243053 110290283
Opportunistic infection 25.31 16.86 18 55945 3525 110529811
Drug ineffective 25.19 16.86 973 54990 1519567 109013769
Chylothorax 24.84 16.86 12 55951 1144 110532192
Liver function test increased 24.83 16.86 7 55956 88541 110444795
Arthritis 24.72 16.86 29 55934 167557 110365779
Paraesthesia 24.38 16.86 66 55897 276455 110256881
Dry skin 24.34 16.86 12 55951 107641 110425695
Heart rate decreased 24.23 16.86 6 55957 82750 110450586
International normalised ratio increased 24.07 16.86 7 55956 86765 110446571
Enterococcal sepsis 24.06 16.86 17 55946 3295 110530041
Cytomegalovirus gastritis 23.93 16.86 10 55953 678 110532658
Rhinorrhoea 23.89 16.86 11 55952 102655 110430681
Dermatitis 23.73 16.86 47 55916 27790 110505546
Muscular weakness 23.68 16.86 57 55906 248411 110284925
Cytomegalovirus gastroenteritis 23.41 16.86 10 55953 716 110532620
Eastern Cooperative Oncology Group performance status worsened 23.35 16.86 16 55947 2953 110530383
Acute graft versus host disease in skin 23.34 16.86 28 55935 10712 110522624
Adverse event 23.31 16.86 13 55950 108796 110424540
Heart rate increased 23.31 16.86 23 55940 143811 110389525
Leukaemic lymphoma 23.27 16.86 6 55957 85 110533251
Escherichia bacteraemia 22.92 16.86 27 55936 10137 110523199
Blood glucose increased 22.88 16.86 20 55943 132476 110400860
Bradycardia 22.84 16.86 27 55936 155490 110377846
Multiple organ dysfunction syndrome 22.76 16.86 143 55820 151567 110381769
Pneumonia viral 22.49 16.86 28 55935 11129 110522207
Klebsiella infection 22.39 16.86 38 55925 19971 110513365
Mucosal inflammation 22.19 16.86 102 55861 96039 110437297
Illness 22.12 16.86 7 55956 82164 110451172
Fungal oesophagitis 22.00 16.86 11 55952 1130 110532206
Metastases to spleen 21.96 16.86 10 55953 834 110532502
Neutrophil Pelger-Huet anomaly present 21.68 16.86 8 55955 389 110532947
Cell-mediated immune deficiency 21.59 16.86 7 55956 230 110533106
Injection site reaction 21.59 16.86 9 55954 89061 110444275
Hypoglossal nerve paresis 21.52 16.86 6 55957 116 110533220
Neutrophil count abnormal 21.41 16.86 19 55944 5113 110528223
Rosai-Dorfman syndrome 21.36 16.86 5 55958 46 110533290
Incorrect dose administered 21.33 16.86 13 55950 103628 110429708
Escherichia infection 21.26 16.86 41 55922 23775 110509561
Immune system disorder 21.22 16.86 30 55933 13471 110519865
Chronic lymphocytic leukaemia refractory 21.15 16.86 6 55957 124 110533212
Drug reaction with eosinophilia and systemic symptoms 21.14 16.86 90 55873 82005 110451331
High-grade B-cell lymphoma 21.08 16.86 7 55956 248 110533088
Hyperuricaemia 20.96 16.86 31 55932 14500 110518836
Wrong technique in product usage process 20.89 16.86 9 55954 87339 110445997
Blood pressure fluctuation 20.82 16.86 6 55957 74818 110458518
Klebsiella sepsis 20.64 16.86 17 55946 4136 110529200
Sphingomonas paucimobilis infection 20.62 16.86 6 55957 136 110533200
Cardio-respiratory arrest 20.59 16.86 17 55946 115819 110417517
Blood immunoglobulin G abnormal 20.50 16.86 6 55957 139 110533197
Nocardiosis 20.49 16.86 22 55941 7464 110525872
Hallucination 20.49 16.86 13 55950 101419 110431917
Cytomegalovirus oesophagitis 20.48 16.86 10 55953 976 110532360
Adenocarcinoma of colon 20.27 16.86 20 55943 6148 110527188
Rheumatoid factor positive 20.26 16.86 22 55941 131618 110401718
Disseminated toxoplasmosis 20.25 16.86 8 55955 469 110532867
Ilium fracture 20.23 16.86 7 55956 282 110533054
VIth nerve paresis 20.22 16.86 6 55957 146 110533190
Blood immunoglobulin M abnormal 20.14 16.86 6 55957 148 110533188
Mixed dementia 20.13 16.86 7 55956 286 110533050
Radiation injury 20.08 16.86 10 55953 1018 110532318
Infusion site phlebitis 20.06 16.86 6 55957 150 110533186
Urticaria 20.05 16.86 88 55875 318769 110214567
Adenoviral encephalitis 20.00 16.86 5 55958 62 110533274
Babesiosis 19.96 16.86 8 55955 487 110532849
Respiratory failure 19.86 16.86 181 55782 215151 110318185
Metabolic acidosis 19.85 16.86 13 55950 99731 110433605
Acquired C1 inhibitor deficiency 19.73 16.86 4 55959 17 110533319
Febrile infection 19.63 16.86 17 55946 4431 110528905
Retroperitoneal lymphadenopathy 19.62 16.86 11 55952 1425 110531911
C-reactive protein abnormal 19.60 16.86 22 55941 129673 110403663
Loss of consciousness 19.54 16.86 44 55919 196262 110337074
Blood pressure decreased 19.51 16.86 112 55851 114979 110418357
Ear infection 19.47 16.86 4 55959 62728 110470608
Stevens-Johnson syndrome 19.39 16.86 60 55903 46841 110486495
Neurotoxicity 19.35 16.86 56 55907 42151 110491185
Cytokine storm 19.24 16.86 11 55952 1479 110531857
Extranodal marginal zone B-cell lymphoma (MALT type) recurrent 19.20 16.86 4 55959 20 110533316
Granulocyte count decreased 19.20 16.86 16 55947 3958 110529378
Renal failure 19.18 16.86 187 55776 226387 110306949
T-cell lymphoma stage IV 19.12 16.86 6 55957 177 110533159
Injection site erythema 19.12 16.86 12 55951 94164 110439172
Chest discomfort 18.95 16.86 37 55926 173811 110359525
Infection reactivation 18.83 16.86 16 55947 4065 110529271
Schistocytosis 18.82 16.86 5 55958 80 110533256
Tumour flare 18.72 16.86 11 55952 1556 110531780
Alopecia scarring 18.69 16.86 6 55957 191 110533145
Drug-induced liver injury 18.55 16.86 20 55943 120047 110413289
Nephropathy toxic 18.34 16.86 42 55921 27436 110505900
Treatment noncompliance 18.30 16.86 7 55956 72983 110460353
Oropharyngeal pain 18.29 16.86 25 55938 135251 110398085
Hyperthermia 18.23 16.86 36 55927 21236 110512100
Myalgia 18.19 16.86 55 55908 222326 110311010
Varicella zoster oesophagitis 18.05 16.86 4 55959 28 110533308
Cryoglobulinaemia 18.02 16.86 10 55953 1269 110532067
Pneumocystis jirovecii infection 17.78 16.86 16 55947 4384 110528952
Lung adenocarcinoma 17.75 16.86 23 55940 9508 110523828
Lymphoplasmacytoid lymphoma/immunocytoma refractory 17.69 16.86 3 55960 3 110533333
Lymphocytic lymphoma 17.68 16.86 5 55958 102 110533234
Immunosuppression 17.63 16.86 32 55931 17727 110515609
Renal tubular necrosis 17.56 16.86 44 55919 30431 110502905
Coagulation factor V level decreased 17.48 16.86 8 55955 675 110532661
Pelvic venous thrombosis 17.38 16.86 13 55950 2751 110530585
Generalised oedema 17.35 16.86 44 55919 30660 110502676
Blood uric acid abnormal 17.27 16.86 7 55956 439 110532897
Pneumothorax spontaneous 17.22 16.86 11 55952 1806 110531530
Mucosal erosion 17.13 16.86 13 55950 2811 110530525
Infusion site extravasation 17.04 16.86 25 55938 11609 110521727
Myositis 16.97 16.86 44 55919 31072 110502264
Left ventricular dysfunction 16.90 16.86 37 55926 23456 110509880
Autoimmune disorder 16.89 16.86 6 55957 65477 110467859
Glomerular filtration rate decreased 16.89 16.86 42 55921 28914 110504422
Hepatitis B e antigen positive 16.88 16.86 4 55959 39 110533297
Cardiomyopathy 16.86 16.86 46 55917 33479 110499857

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC L01AA09 ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
ANTINEOPLASTIC AGENTS
ALKYLATING AGENTS
Nitrogen mustard analogues
FDA MoA N0000000236 Alkylating Activity
FDA EPC N0000175558 Alkylating Drug
MeSH PA D000477 Alkylating Agents
MeSH PA D000970 Antineoplastic Agents
MeSH PA D018906 Antineoplastic Agents, Alkylating
CHEBI has role CHEBI:35610 antineoplastic agent
CHEBI has role CHEBI:75835 anti-anaemic agent

Related Drugs by ATC class:

L01AA Nitrogen mustard analogues 8 drugs
chlorambucilcyclophosphamideifosfamidemechlorethaminemelphalanmelphalan flufenamideprednimustinetrofosfamide

Drug Use | Suggest Off label Use Form| |View source of the data|

DiseaseRelationSNOMED_IDDOID
Chronic lymphoid leukemia, disease indication 92814006
Follicular non-Hodgkin's lymphoma indication 308121000
Treatment prior to tumor-specific T-cell infusion therapy indication
Indolent B-Cell Lymphoma indication
Diffuse large B-cell lymphoma refractory indication
Mantle cell lymphoma off-label use 443487006
Fluid volume disorder contraindication 1860003
Hyperkalemia contraindication 14140009
Acute nephropathy contraindication 58574008
Hepatic failure contraindication 59927004
Acute infectious disease contraindication 63171007
Kidney disease contraindication 90708001 DOID:557
Disease of liver contraindication 235856003 DOID:409
Anemia contraindication 271737000 DOID:2355
Pregnancy, function contraindication 289908002
Thrombocytopenic disorder contraindication 302215000 DOID:1588
Neutropenic disorder contraindication 303011007 DOID:1227
Bone marrow depression contraindication 307762000
Breastfeeding (mother) contraindication 413712001
Smokes tobacco daily contraindication 449868002
Chemotherapy-Induced Hyperuricemia contraindication




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 4.61 acidic
pKa2 6.18 Basic
pKa3 2.83 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
100MG/VIAL TREANDA CEPHALON N022249 March 20, 2008 RX POWDER INTRAVENOUS 8791270 Jan. 12, 2026 FOR USE IN THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA AND/OR NON-HODGKINS LYMPHOMA
180MG/2ML (90MG/ML) TREANDA CEPHALON N022249 Sept. 13, 2013 DISCN SOLUTION INTRAVENOUS 8791270 Jan. 12, 2026 FOR USE IN THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA AND/OR NON-HODGKINS LYMPHOMA
25MG/VIAL TREANDA CEPHALON N022249 May 1, 2009 RX POWDER INTRAVENOUS 8791270 Jan. 12, 2026 FOR USE IN THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA AND/OR NON-HODGKINS LYMPHOMA
45MG/0.5ML (90MG/ML) TREANDA CEPHALON N022249 Sept. 13, 2013 DISCN SOLUTION INTRAVENOUS 8791270 Jan. 12, 2026 FOR USE IN THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA AND/OR NON-HODGKINS LYMPHOMA
100MG/4ML (25MG/ML) BELRAPZO EAGLE PHARMS N205580 May 15, 2018 RX SOLUTION INTRAVENOUS 8791270 Jan. 12, 2026 FOR THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA
100MG/4ML (25MG/ML) BELRAPZO EAGLE PHARMS N205580 May 15, 2018 RX SOLUTION INTRAVENOUS 8791270 Jan. 12, 2026 FOR THE TREATMENT OF PATIENTS WITH INDOLENT B-CELL NON-HODGKIN LYMPHOMA
100MG/4ML (25MG/ML) BENDEKA EAGLE PHARMS N208194 Dec. 7, 2015 RX SOLUTION INTRAVENOUS 8791270 Jan. 12, 2026 FOR USE IN TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) AND/OR NON-HODGKINS LYMPHOMA
100MG/VIAL TREANDA CEPHALON N022249 March 20, 2008 RX POWDER INTRAVENOUS 8445524 March 26, 2029 FOR USE IN THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) AND/OR INDOLENT B-CELL NON-HODGKIN LYMPHOMA (NHL)
100MG/VIAL TREANDA CEPHALON N022249 March 20, 2008 RX POWDER INTRAVENOUS 8669279 March 26, 2029 FOR USE IN THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) AND/OR INDOLENT B-CELL NON-HODGKIN LYMPHOMA (NHL)
100MG/VIAL TREANDA CEPHALON N022249 March 20, 2008 RX POWDER INTRAVENOUS 8883836 March 26, 2029 FOR USE IN THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) AND/OR INDOLENT B-CELL NON-HODGKIN LYMPHOMA (NHL)
100MG/VIAL TREANDA CEPHALON N022249 March 20, 2008 RX POWDER INTRAVENOUS 9533955 March 26, 2029 FOR USE IN THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL)
100MG/VIAL TREANDA CEPHALON N022249 March 20, 2008 RX POWDER INTRAVENOUS 9533955 March 26, 2029 FOR USE IN THE TREATMENT OF PATIENTS WITH INDOLENT B-CELL NON-HODGKIN LYMPHOMA
25MG/VIAL TREANDA CEPHALON N022249 May 1, 2009 RX POWDER INTRAVENOUS 8445524 March 26, 2029 FOR USE IN THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) AND/OR INDOLENT B-CELL NON-HODGKIN LYMPHOMA (NHL)
25MG/VIAL TREANDA CEPHALON N022249 May 1, 2009 RX POWDER INTRAVENOUS 8669279 March 26, 2029 FOR USE IN THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) AND/OR INDOLENT B-CELL NON-HODGKIN LYMPHOMA (NHL)
25MG/VIAL TREANDA CEPHALON N022249 May 1, 2009 RX POWDER INTRAVENOUS 8883836 March 26, 2029 FOR USE IN THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) AND/OR INDOLENT B-CELL NON-HODGKIN LYMPHOMA (NHL)
25MG/VIAL TREANDA CEPHALON N022249 May 1, 2009 RX POWDER INTRAVENOUS 9533955 March 26, 2029 FOR USE IN THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL)
25MG/VIAL TREANDA CEPHALON N022249 May 1, 2009 RX POWDER INTRAVENOUS 9533955 March 26, 2029 FOR USE IN THE TREATMENT OF PATIENTS WITH INDOLENT B-CELL NON-HODGKIN LYMPHOMA
180MG/2ML (90MG/ML) TREANDA CEPHALON N022249 Sept. 13, 2013 DISCN SOLUTION INTRAVENOUS 8344006 Sept. 23, 2029 FOR USE IN THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) AND/OR INDOLENT B-CELL NON-HODGKIN LYMPHOMA (NHL)
45MG/0.5ML (90MG/ML) TREANDA CEPHALON N022249 Sept. 13, 2013 DISCN SOLUTION INTRAVENOUS 8344006 Sept. 23, 2029 FOR USE IN THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) AND/OR INDOLENT B-CELL NON-HODGKIN LYMPHOMA (NHL)
100MG/4ML (25MG/ML) BELRAPZO EAGLE PHARMS N205580 May 15, 2018 RX SOLUTION INTRAVENOUS 11103483 Jan. 28, 2031 FOR THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA
100MG/4ML (25MG/ML) BELRAPZO EAGLE PHARMS N205580 May 15, 2018 RX SOLUTION INTRAVENOUS 11103483 Jan. 28, 2031 FOR THE TREATMENT OF PATIENTS WITH INDOLENT B-CELL NON-HODGKIN LYMPHOMA
100MG/4ML (25MG/ML) BELRAPZO EAGLE PHARMS N205580 May 15, 2018 RX SOLUTION INTRAVENOUS 11844783 Jan. 28, 2031 FOR THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA
100MG/4ML (25MG/ML) BELRAPZO EAGLE PHARMS N205580 May 15, 2018 RX SOLUTION INTRAVENOUS 11844783 Jan. 28, 2031 FOR THE TREATMENT OF PATIENTS WITH INDOLENT B-CELL NON-HODGKIN LYMPHOMA
100MG/4ML (25MG/ML) BELRAPZO EAGLE PHARMS N205580 May 15, 2018 RX SOLUTION INTRAVENOUS 11844783 Jan. 28, 2031 FOR USE IN THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA AND/OR NON-HODGKINS LYMPHOMA
100MG/4ML (25MG/ML) BELRAPZO EAGLE PHARMS N205580 May 15, 2018 RX SOLUTION INTRAVENOUS 12350257 Jan. 28, 2031 FOR THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA
100MG/4ML (25MG/ML) BELRAPZO EAGLE PHARMS N205580 May 15, 2018 RX SOLUTION INTRAVENOUS 12350257 Jan. 28, 2031 FOR THE TREATMENT OF PATIENTS WITH INDOLENT B-CELL NON-HODGKIN LYMPHOMA
100MG/4ML (25MG/ML) BELRAPZO EAGLE PHARMS N205580 May 15, 2018 RX SOLUTION INTRAVENOUS 12350257 Jan. 28, 2031 FOR USE IN THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA AND/OR NON-HODGKINS LYMPHOMA
100MG/4ML (25MG/ML) BELRAPZO EAGLE PHARMS N205580 May 15, 2018 RX SOLUTION INTRAVENOUS 9572796 Jan. 28, 2031 FOR THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA
100MG/4ML (25MG/ML) BELRAPZO EAGLE PHARMS N205580 May 15, 2018 RX SOLUTION INTRAVENOUS 9572796 Jan. 28, 2031 FOR THE TREATMENT OF PATIENTS WITH INDOLENT B-CELL NON-HODGKIN LYMPHOMA
100MG/4ML (25MG/ML) BELRAPZO EAGLE PHARMS N205580 May 15, 2018 RX SOLUTION INTRAVENOUS 9572797 Jan. 28, 2031 FOR THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA
100MG/4ML (25MG/ML) BELRAPZO EAGLE PHARMS N205580 May 15, 2018 RX SOLUTION INTRAVENOUS 9572797 Jan. 28, 2031 FOR THE TREATMENT OF PATIENTS WITH INDOLENT B-CELL NON-HODGKIN LYMPHOMA
100MG/4ML (25MG/ML) BENDEKA EAGLE PHARMS N208194 Dec. 7, 2015 RX SOLUTION INTRAVENOUS 11103483 Jan. 28, 2031 FOR THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA
100MG/4ML (25MG/ML) BENDEKA EAGLE PHARMS N208194 Dec. 7, 2015 RX SOLUTION INTRAVENOUS 11103483 Jan. 28, 2031 FOR THE TREATMENT OF PATIENTS WITH INDOLENT B-CELL NON-HODGKIN LYMPHOMA
100MG/4ML (25MG/ML) BENDEKA EAGLE PHARMS N208194 Dec. 7, 2015 RX SOLUTION INTRAVENOUS 11844783 Jan. 28, 2031 FOR THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA
100MG/4ML (25MG/ML) BENDEKA EAGLE PHARMS N208194 Dec. 7, 2015 RX SOLUTION INTRAVENOUS 11844783 Jan. 28, 2031 FOR THE TREATMENT OF PATIENTS WITH INDOLENT B-CELL NON-HODGKIN LYMPHOMA
100MG/4ML (25MG/ML) BENDEKA EAGLE PHARMS N208194 Dec. 7, 2015 RX SOLUTION INTRAVENOUS 11844783 Jan. 28, 2031 FOR USE IN THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA AND/OR NON-HODGKINS LYMPHOMA
100MG/4ML (25MG/ML) BENDEKA EAGLE PHARMS N208194 Dec. 7, 2015 RX SOLUTION INTRAVENOUS 12350257 Jan. 28, 2031 FOR THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA
100MG/4ML (25MG/ML) BENDEKA EAGLE PHARMS N208194 Dec. 7, 2015 RX SOLUTION INTRAVENOUS 12350257 Jan. 28, 2031 FOR THE TREATMENT OF PATIENTS WITH INDOLENT B-CELL NON-HODGKIN LYMPHOMA
100MG/4ML (25MG/ML) BENDEKA EAGLE PHARMS N208194 Dec. 7, 2015 RX SOLUTION INTRAVENOUS 12350257 Jan. 28, 2031 FOR USE IN THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA AND/OR NON-HODGKINS LYMPHOMA
100MG/4ML (25MG/ML) BENDEKA EAGLE PHARMS N208194 Dec. 7, 2015 RX SOLUTION INTRAVENOUS 9572796 Jan. 28, 2031 FOR THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA
100MG/4ML (25MG/ML) BENDEKA EAGLE PHARMS N208194 Dec. 7, 2015 RX SOLUTION INTRAVENOUS 9572796 Jan. 28, 2031 FOR THE TREATMENT OF PATIENTS WITH INDOLENT B-CELL NON-HODGKIN LYMPHOMA
100MG/4ML (25MG/ML) BENDEKA EAGLE PHARMS N208194 Dec. 7, 2015 RX SOLUTION INTRAVENOUS 9572797 Jan. 28, 2031 FOR THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA
100MG/4ML (25MG/ML) BENDEKA EAGLE PHARMS N208194 Dec. 7, 2015 RX SOLUTION INTRAVENOUS 9572797 Jan. 28, 2031 FOR THE TREATMENT OF PATIENTS WITH INDOLENT B-CELL NON-HODGKIN LYMPHOMA
100MG/4ML (25MG/ML) BELRAPZO EAGLE PHARMS N205580 May 15, 2018 RX SOLUTION INTRAVENOUS 8609707 Aug. 11, 2031 FOR THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA
100MG/4ML (25MG/ML) BELRAPZO EAGLE PHARMS N205580 May 15, 2018 RX SOLUTION INTRAVENOUS 8609707 Aug. 11, 2031 FOR THE TREATMENT OF PATIENTS WITH INDOLENT B-CELL NON-HODGKIN LYMPHOMA
100MG/4ML (25MG/ML) BENDEKA EAGLE PHARMS N208194 Dec. 7, 2015 RX SOLUTION INTRAVENOUS 8609707 Aug. 11, 2031 FOR USE IN THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA AND/OR NON-HODGKINS LYMPHOMA
100MG/4ML (25MG/ML) BENDEKA EAGLE PHARMS N208194 Dec. 7, 2015 RX SOLUTION INTRAVENOUS 10052385 March 15, 2033 FOR THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA
100MG/4ML (25MG/ML) BENDEKA EAGLE PHARMS N208194 Dec. 7, 2015 RX SOLUTION INTRAVENOUS 10052385 March 15, 2033 FOR THE TREATMENT OF PATIENTS WITH INDOLENT B-CELL NON-HODGKIN LYMPHOMA
100MG/4ML (25MG/ML) BENDEKA EAGLE PHARMS N208194 Dec. 7, 2015 RX SOLUTION INTRAVENOUS 9000021 March 15, 2033 FOR USE IN THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA AND/OR NON-HODGKINS LYMPHOMA
100MG/4ML (25MG/ML) BENDEKA EAGLE PHARMS N208194 Dec. 7, 2015 RX SOLUTION INTRAVENOUS 9034908 March 15, 2033 FOR USE IN THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA AND/OR NON-HODGKINS LYMPHOMA
100MG/4ML (25MG/ML) BENDEKA EAGLE PHARMS N208194 Dec. 7, 2015 RX SOLUTION INTRAVENOUS 9144568 March 15, 2033 FOR USE IN THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA AND/OR NON-HODGKINS LYMPHOMA
100MG/4ML (25MG/ML) BENDEKA EAGLE PHARMS N208194 Dec. 7, 2015 RX SOLUTION INTRAVENOUS 9572887 March 15, 2033 FOR THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA
100MG/4ML (25MG/ML) BENDEKA EAGLE PHARMS N208194 Dec. 7, 2015 RX SOLUTION INTRAVENOUS 9572887 March 15, 2033 FOR THE TREATMENT OF PATIENTS WITH INDOLENT B-CELL NON-HODGKIN LYMPHOMA
100MG/4ML (25MG/ML) BENDEKA EAGLE PHARMS N208194 Dec. 7, 2015 RX SOLUTION INTRAVENOUS 9579384 March 15, 2033 FOR THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA
100MG/4ML (25MG/ML) BENDEKA EAGLE PHARMS N208194 Dec. 7, 2015 RX SOLUTION INTRAVENOUS 9579384 March 15, 2033 FOR THE TREATMENT OF PATIENTS WITH INDOLENT B-CELL NON-HODGKIN LYMPHOMA
100MG/4ML (25MG/ML) BENDEKA EAGLE PHARMS N208194 Dec. 7, 2015 RX SOLUTION INTRAVENOUS 9597397 March 15, 2033 FOR THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA
100MG/4ML (25MG/ML) BENDEKA EAGLE PHARMS N208194 Dec. 7, 2015 RX SOLUTION INTRAVENOUS 9597397 March 15, 2033 FOR THE TREATMENT OF PATIENTS WITH INDOLENT B-CELL NON-HODGKIN LYMPHOMA
100MG/4ML (25MG/ML) BENDEKA EAGLE PHARMS N208194 Dec. 7, 2015 RX SOLUTION INTRAVENOUS 9597398 March 15, 2033 FOR THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA
100MG/4ML (25MG/ML) BENDEKA EAGLE PHARMS N208194 Dec. 7, 2015 RX SOLUTION INTRAVENOUS 9597399 March 15, 2033 FOR THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA
100MG/4ML (25MG/ML) BENDEKA EAGLE PHARMS N208194 Dec. 7, 2015 RX SOLUTION INTRAVENOUS 9597399 March 15, 2033 FOR THE TREATMENT OF PATIENTS WITH INDOLENT B-CELL NON-HODGKIN LYMPHOMA

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])		Mechanism
action		Bioact sourceMoA source
Histone deacetylase 5 Enzyme IC50 8 CHEMBL
Histone deacetylase 2 Enzyme IC50 8.05 CHEMBL
Histone deacetylase 1 Enzyme IC50 7.77 CHEMBL
Histone deacetylase 3 Enzyme IC50 7.60 CHEMBL
Histone deacetylase 6 Enzyme IC50 8.22 CHEMBL
Histone deacetylase 8 Enzyme IC50 6.97 CHEMBL
Histone deacetylase 4 Enzyme IC50 8 CHEMBL
Histone deacetylase 10 Enzyme IC50 7.14 CHEMBL

External reference:

IDSource
4027339 VUID
N0000179513 NUI
D07085 KEGG_DRUG
3543-75-7 SECONDARY_CAS_RN
1114693 RXNORM
C0525079 UMLSCUI
CHEBI:135515 CHEBI
CHEMBL487253 ChEMBL_ID
DB06769 DRUGBANK_ID
CHEMBL1201734 ChEMBL_ID
D000069461 MESH_DESCRIPTOR_UI
65628 PUBCHEM_CID
7478 IUPHAR_LIGAND_ID
5228 INN_ID
9266D9P3PQ UNII
132929 MMSL
241056 MMSL
25220 MMSL
275320 MMSL
d07121 MMSL
4027339 VANDF
006925 NDDF
006926 NDDF
427812009 SNOMEDCT_US
428012008 SNOMEDCT_US
430082006 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
BENDAMUSTINE HYDROCHLORIDE HUMAN PRESCRIPTION DRUG LABEL 1 10019-079 INJECTION 100 mg INTRAVENOUS NDA 26 sections
bendamustine hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 16729-250 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 25 mg INTRAVENOUS ANDA 26 sections
bendamustine hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 16729-251 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 100 mg INTRAVENOUS ANDA 26 sections
VIVIMUSTA Human Prescription Drug Label 1 24338-270 INJECTION 25 mg INTRAVENOUS NDA 25 sections
BELRAPZO HUMAN PRESCRIPTION DRUG LABEL 1 42367-521 INJECTION 100 mg INTRAVENOUS NDA 28 sections
BENDAMUSTINE HYDROCHLORIDE Human Prescription Drug Label 1 55150-391 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 25 mg INTRAVENOUS ANDA 27 sections
BENDAMUSTINE HYDROCHLORIDE Human Prescription Drug Label 1 55150-392 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 100 mg INTRAVENOUS ANDA 27 sections
Bendamustine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 60505-6228 INJECTION, SOLUTION 25 mg INTRAVENOUS NDA 25 sections
Bendeka HUMAN PRESCRIPTION DRUG LABEL 1 63459-348 INJECTION, SOLUTION 25 mg INTRAVENOUS NDA 31 sections
TREANDA HUMAN PRESCRIPTION DRUG LABEL 1 63459-390 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 25 mg INTRAVENOUS NDA 26 sections
TREANDA HUMAN PRESCRIPTION DRUG LABEL 1 63459-391 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 100 mg INTRAVENOUS NDA 26 sections
TREANDA HUMAN PRESCRIPTION DRUG LABEL 1 63459-395 INJECTION, SOLUTION, CONCENTRATE 45 mg INTRAVENOUS NDA 26 sections
TREANDA HUMAN PRESCRIPTION DRUG LABEL 1 63459-396 INJECTION, SOLUTION, CONCENTRATE 180 mg INTRAVENOUS NDA 26 sections
bendamustine hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 68001-571 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 25 mg INTRAVENOUS ANDA 26 sections
bendamustine hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 68001-572 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 100 mg INTRAVENOUS ANDA 26 sections
VIVIMUSTA Human Prescription Drug Label 1 71225-120 INJECTION 25 mg INTRAVENOUS NDA 25 sections
Bendamustine HUMAN PRESCRIPTION DRUG LABEL 1 71288-102 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 25 mg INTRAVENOUS ANDA 28 sections
Bendamustine HUMAN PRESCRIPTION DRUG LABEL 1 71288-103 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 100 mg INTRAVENOUS ANDA 28 sections
BENDAMUSTINE HYDROCHLORIDE HUMAN PRESCRIPTION DRUG LABEL 1 83831-183 INJECTION 100 mg INTRAVENOUS NDA 24 sections