cyclophosphamide Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
alkylating agents of the cyclophosphamide group 758 50-18-0

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • cyclophosphamide
  • cyclophosphamid
  • cyclophosphamidum
  • cyclophosphan
  • cyclophosphane
  • cytophosphan
  • mitoxan
  • cyclophosphamide hydrate
Precursor of an alkylating nitrogen mustard antineoplastic and immunosuppressive agent that must be activated in the LIVER to form the active aldophosphamide. It has been used in the treatment of LYMPHOMA and LEUKEMIA. Its side effect, ALOPECIA, has been used for defleecing sheep. Cyclophosphamide may also cause sterility, birth defects, mutations, and cancer.
  • Molecular weight: 261.08
  • Formula: C7H15Cl2N2O2P
  • CLOGP: 0.80
  • LIPINSKI: 0
  • HAC: 4
  • HDO: 1
  • TPSA: 41.57
  • ALOGS: -1.24
  • ROTB: 5

  • 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
S (Water solubility) 40 mg/mL Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 6.50 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 19.15 ┬ÁM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 74 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution) 0.73 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 1.10 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.87 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 8 hours Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
Nov. 16, 1959 FDA BAXTER HLTHCARE

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
Febrile neutropenia 7360.33 43.85 1809 17095 9073 2330108
Neutropenia 4061.36 43.85 1323 17581 20225 2318956
Pyrexia 2217.80 43.85 1106 17798 52602 2286579
Product use in unapproved indication 1828.72 43.85 620 18284 10580 2328601
Acute myeloid leukaemia 1629.05 43.85 413 18491 2297 2336884
Pancytopenia 1491.73 43.85 536 18368 10916 2328265
Sepsis 1429.98 43.85 592 18312 17896 2321285
Mucosal inflammation 1421.04 43.85 427 18477 4797 2334384
Thrombocytopenia 1366.86 43.85 579 18325 18552 2320629
Pneumonia 1345.57 43.85 773 18131 48523 2290658
Anaemia 1296.72 43.85 671 18233 34121 2305060
Bone marrow failure 1172.30 43.85 376 18528 5310 2333871
Myelodysplastic syndrome 1170.10 43.85 314 18590 2246 2336935
Leukopenia 1064.61 43.85 406 18498 9790 2329391
Neutropenic sepsis 1011.98 43.85 249 18655 1193 2337988
Nausea 1009.97 43.85 893 18011 111296 2227885
Off label use 968.94 43.85 732 18172 72866 2266315
Cytomegalovirus infection 882.66 43.85 255 18649 2458 2336723
Vomiting 875.76 43.85 682 18222 70920 2268261
Second primary malignancy 840.60 43.85 200 18704 806 2338375
Septic shock 816.09 43.85 303 18601 6751 2332430
Pneumocystis jirovecii pneumonia 799.19 43.85 227 18677 2046 2337135
Diarrhoea 793.37 43.85 687 18217 82877 2256304
Disease progression 731.88 43.85 363 18541 16732 2322449
Pleural effusion 726.26 43.85 321 18583 11347 2327834
Infection 725.29 43.85 367 18537 17662 2321519
Haematotoxicity 715.99 43.85 181 18723 986 2338195
Respiratory failure 708.67 43.85 330 18574 13198 2325983
Malignant neoplasm progression 704.78 43.85 318 18586 11810 2327371
Neuropathy peripheral 696.99 43.85 310 18594 11122 2328059
Ejection fraction decreased 684.03 43.85 211 18693 2590 2336591
Febrile bone marrow aplasia 667.45 43.85 161 18743 696 2338485
White blood cell count decreased 618.53 43.85 331 18573 17877 2321304
Neutrophil count decreased 611.83 43.85 241 18663 6326 2332855
Posterior reversible encephalopathy syndrome 602.06 43.85 186 18718 2294 2336887
Multiple organ dysfunction syndrome 593.37 43.85 246 18658 7395 2331786
Premature menopause 584.36 43.85 115 18789 124 2339057
Progressive multifocal leukoencephalopathy 558.54 43.85 171 18733 2041 2337140
General physical health deterioration 554.20 43.85 283 18621 13856 2325325
Dyspnoea 547.48 43.85 545 18359 78188 2260993
Fatigue 522.12 43.85 550 18354 84323 2254858
Cystitis haemorrhagic 518.52 43.85 124 18780 512 2338669
Cardiomyopathy 514.44 43.85 170 18734 2637 2336544
Cardiotoxicity 508.79 43.85 140 18764 1107 2338074
Pulmonary embolism 496.88 43.85 286 18618 17797 2321384
Left ventricular dysfunction 495.70 43.85 137 18767 1103 2338078
Tumour lysis syndrome 486.69 43.85 131 18773 944 2338237
Hepatitis B 479.35 43.85 123 18781 717 2338464
Venoocclusive liver disease 477.39 43.85 115 18789 493 2338688
Platelet count decreased 477.31 43.85 266 18638 15547 2323634
Asthenia 476.33 43.85 402 18502 46524 2292657
Stomatitis 474.64 43.85 226 18678 9484 2329697
Cardiac failure 450.48 43.85 234 18670 11860 2327321
Interstitial lung disease 425.54 43.85 196 18708 7616 2331565
Hypotension 420.65 43.85 321 18583 32115 2307066
Haemoglobin decreased 414.84 43.85 255 18649 17896 2321285
Metastases to bone 410.05 43.85 136 18768 2133 2337048
Disease recurrence 401.48 43.85 149 18755 3302 2335879
Graft versus host disease 383.50 43.85 106 18798 853 2338328
Palmar-plantar erythrodysaesthesia syndrome 376.48 43.85 150 18754 4051 2335130
Dehydration 373.99 43.85 258 18646 22037 2317144
Bacteraemia 370.71 43.85 118 18786 1612 2337569
Hypokalaemia 370.66 43.85 197 18707 10457 2328724
Drug ineffective 356.90 43.85 496 18408 101128 2238053
Exposure during pregnancy 345.39 43.85 258 18646 24961 2314220
Renal failure 344.41 43.85 223 18681 17126 2322055
Deep vein thrombosis 342.90 43.85 200 18704 12732 2326449
Peripheral sensory neuropathy 335.55 43.85 97 18807 933 2338248
Colitis 331.85 43.85 146 18758 5080 2334101
Acute promyelocytic leukaemia 321.15 43.85 71 18833 187 2338994
Neoplasm progression 314.57 43.85 136 18768 4532 2334649
Maternal exposure during pregnancy 307.18 43.85 196 18708 14667 2324514
Hepatic failure 304.29 43.85 141 18763 5548 2333633
Alopecia 303.22 43.85 226 18678 21775 2317406
Abdominal pain 296.92 43.85 269 18635 34105 2305076
Acute kidney injury 295.19 43.85 246 18658 27876 2311305
Staphylococcal infection 291.08 43.85 134 18770 5192 2333989
Lymphopenia 289.22 43.85 107 18797 2347 2336834
Ovarian failure 285.82 43.85 65 18839 203 2338978
Cough 283.72 43.85 258 18646 32859 2306322
Metastases to liver 280.93 43.85 110 18794 2831 2336350
Acute graft versus host disease 280.17 43.85 75 18829 527 2338654
Neurotoxicity 277.50 43.85 100 18804 2030 2337151
Bronchopulmonary aspergillosis 276.41 43.85 83 18821 921 2338260
Adenovirus infection 276.18 43.85 66 18838 271 2338910
Decreased appetite 261.07 43.85 232 18672 28659 2310522
Atrial fibrillation 256.11 43.85 170 18734 13598 2325583
Aspergillus infection 253.88 43.85 77 18827 886 2338295
Pneumonitis 253.67 43.85 112 18792 3927 2335254
Epstein-Barr virus infection 251.35 43.85 79 18825 1032 2338149
Haemophagocytic lymphohistiocytosis 250.24 43.85 83 18821 1300 2337881
Lung infiltration 249.57 43.85 94 18810 2170 2337011
Toxicity to various agents 249.36 43.85 239 18665 32515 2306666
Acute lymphocytic leukaemia 246.84 43.85 65 18839 425 2338756
Candida infection 244.94 43.85 99 18805 2774 2336407
Chills 239.66 43.85 171 18733 15381 2323800
Constipation 238.95 43.85 195 18709 21434 2317747
Diffuse large B-cell lymphoma recurrent 238.59 43.85 47 18857 51 2339130
Ascites 235.96 43.85 118 18786 5502 2333679
Herpes zoster 235.70 43.85 142 18762 9583 2329598
Hypoxia 230.23 43.85 120 18784 6107 2333074
Aplasia 228.18 43.85 61 18843 426 2338755
Lower respiratory tract infection 228.06 43.85 114 18790 5310 2333871
Syncope 227.15 43.85 171 18733 16704 2322477
Cytomegalovirus viraemia 220.33 43.85 59 18845 415 2338766
Enterococcal infection 219.38 43.85 65 18839 686 2338495
Post transplant lymphoproliferative disorder 218.99 43.85 60 18844 465 2338716
Alanine aminotransferase increased 217.83 43.85 155 18749 13877 2325304
Lymphadenopathy 216.96 43.85 112 18792 5586 2333595
Hyponatraemia 213.34 43.85 150 18754 13175 2326006
Diffuse large B-cell lymphoma 209.95 43.85 65 18839 805 2338376
Urinary tract infection 208.24 43.85 208 18696 29734 2309447
Drug resistance 205.19 43.85 85 18819 2539 2336642
Tachycardia 204.84 43.85 159 18745 16250 2322931
Acute lymphocytic leukaemia recurrent 204.50 43.85 48 18856 179 2339002
Plasma cell myeloma 202.89 43.85 121 18783 8012 2331169
Blood follicle stimulating hormone increased 200.50 43.85 41 18863 62 2339119
Device related infection 200.22 43.85 89 18815 3170 2336011
Hypertension 199.39 43.85 195 18709 27166 2312015
Acute respiratory distress syndrome 199.36 43.85 89 18815 3203 2335978
Venoocclusive disease 196.57 43.85 48 18856 220 2338961
Pericardial effusion 194.72 43.85 93 18811 3916 2335265
Disseminated intravascular coagulation 194.69 43.85 88 18816 3262 2335919
Hypogammaglobulinaemia 194.34 43.85 59 18845 681 2338500
Chronic graft versus host disease 192.55 43.85 51 18853 342 2338839
Agranulocytosis 191.44 43.85 88 18816 3394 2335787
Encephalopathy 189.19 43.85 95 18809 4466 2334715
Seizure 188.86 43.85 180 18724 24286 2314895
Neutropenic colitis 185.61 43.85 47 18857 257 2338924
BK virus infection 185.30 43.85 47 18857 259 2338922
Metastases to lymph nodes 182.04 43.85 60 18844 920 2338261
Acute graft versus host disease in skin 181.35 43.85 49 18855 358 2338823
Cytopenia 180.32 43.85 60 18844 949 2338232
Clostridium difficile colitis 178.44 43.85 72 18832 2007 2337174
Varicella zoster virus infection 177.98 43.85 47 18857 311 2338870
Staphylococcal sepsis 173.22 43.85 59 18845 1006 2338175
Embolism 172.34 43.85 62 18842 1251 2337930
Myocarditis 169.02 43.85 60 18844 1163 2338018
Pseudocirrhosis 168.05 43.85 36 18868 77 2339104
Premature baby 166.88 43.85 78 18826 3126 2336055
Metastases to central nervous system 165.98 43.85 69 18835 2079 2337102
Lung disorder 164.30 43.85 96 18808 6116 2333065
Hepatotoxicity 163.73 43.85 79 18825 3402 2335779
Blood lactate dehydrogenase increased 163.67 43.85 79 18825 3405 2335776
Breast cancer metastatic 162.74 43.85 68 18836 2076 2337105
Neoplasm recurrence 160.82 43.85 45 18859 380 2338801
Hepatic function abnormal 160.73 43.85 94 18810 5998 2333183
Cytokine release syndrome 160.12 43.85 43 18861 306 2338875
Hepatitis B reactivation 159.69 43.85 41 18863 239 2338942
Premature delivery 157.74 43.85 75 18829 3125 2336056
Bone pain 157.41 43.85 107 18797 8889 2330292
Human herpesvirus 6 infection 156.50 43.85 43 18861 337 2338844
Pulmonary oedema 154.21 43.85 98 18806 7265 2331916
Cardiac failure congestive 152.65 43.85 133 18771 15968 2323213
Aspartate aminotransferase increased 152.56 43.85 120 18784 12492 2326689
Systemic candida 152.40 43.85 41 18863 294 2338887
Pneumothorax 148.01 43.85 65 18839 2247 2336934
Blood culture positive 147.90 43.85 48 18856 699 2338482
Bacterial infection 147.24 43.85 64 18840 2157 2337024
Headache 147.09 43.85 293 18611 79886 2259295
Respiratory tract infection 147.05 43.85 77 18827 3952 2335229
Hypoalbuminaemia 146.83 43.85 56 18848 1338 2337843
Pulmonary haemorrhage 146.47 43.85 54 18850 1171 2338010
Breast cancer 145.25 43.85 104 18800 9391 2329790
Hepatitis 144.43 43.85 89 18815 6248 2332933
Amenorrhoea 143.50 43.85 63 18841 2176 2337005
Ovarian atrophy 142.49 43.85 27 18877 19 2339162
Respiratory distress 140.23 43.85 81 18823 5048 2334133
Intestinal perforation 139.96 43.85 58 18846 1733 2337448
Blood bilirubin increased 139.75 43.85 82 18822 5263 2333918
Neutropenic infection 139.55 43.85 34 18870 154 2339027
Kaposi's sarcoma 139.31 43.85 37 18867 251 2338930
Product use issue 139.09 43.85 112 18792 12057 2327124
Hepatocellular injury 138.10 43.85 74 18830 3981 2335200
Polyneuropathy 137.45 43.85 57 18847 1706 2337475
Pulmonary fibrosis 136.65 43.85 64 18840 2576 2336605
Therapy non-responder 136.12 43.85 94 18810 8010 2331171
Graft versus host disease in skin 136.08 43.85 36 18868 240 2338941
Weight decreased 135.83 43.85 162 18742 28209 2310972
C-reactive protein increased 135.35 43.85 85 18819 6170 2333011
Metastases to lung 135.07 43.85 56 18848 1675 2337506
Gastrointestinal toxicity 133.91 43.85 42 18862 544 2338637
Klebsiella infection 131.84 43.85 45 18859 772 2338409
Herpes simplex 131.13 43.85 48 18856 1019 2338162
Enterococcal bacteraemia 130.54 43.85 31 18873 123 2339058
Hypocalcaemia 127.04 43.85 69 18835 3814 2335367
Lupus nephritis 125.98 43.85 35 18869 287 2338894
Subclavian vein thrombosis 125.66 43.85 33 18871 213 2338968
Haematuria 125.57 43.85 71 18833 4247 2334934
Fungal infection 125.18 43.85 74 18830 4815 2334366
Oral candidiasis 124.99 43.85 55 18849 1910 2337271
Stem cell transplant 124.50 43.85 36 18868 346 2338835
Renal impairment 124.14 43.85 97 18807 9995 2329186
Venous thrombosis 123.86 43.85 43 18861 778 2338403
Cognitive disorder 123.70 43.85 76 18828 5305 2333876
Condition aggravated 121.93 43.85 163 18741 31816 2307365
Treatment failure 121.65 43.85 84 18820 7155 2332026
Cardiac arrest 121.15 43.85 113 18791 14817 2324364
Arrhythmia 120.69 43.85 78 18826 5950 2333231
Staphylococcal bacteraemia 120.03 43.85 39 18865 570 2338611
Peripheral motor neuropathy 119.49 43.85 32 18872 225 2338956
Central nervous system lymphoma 119.42 43.85 31 18873 190 2338991
Therapy partial responder 118.74 43.85 35 18869 362 2338819
Primary hypogonadism 118.72 43.85 23 18881 21 2339160
Proteinuria 117.11 43.85 59 18845 2791 2336390
Malaise 116.37 43.85 215 18689 55370 2283811
Bone marrow toxicity 115.84 43.85 34 18870 346 2338835
Portal hypertension 115.59 43.85 37 18867 514 2338667
Pneumonia cytomegaloviral 114.27 43.85 32 18872 271 2338910
Leukoencephalopathy 113.06 43.85 40 18864 767 2338414
Therapeutic response decreased 112.77 43.85 80 18824 7115 2332066
Death 111.90 43.85 265 18639 81203 2257978
Muscular weakness 111.82 43.85 108 18796 14789 2324392
Breast cancer recurrent 111.60 43.85 39 18865 720 2338461
Acute respiratory failure 110.68 43.85 58 18846 2980 2336201
Hyperbilirubinaemia 110.45 43.85 47 18857 1502 2337679
Hodgkin's disease 110.24 43.85 36 18868 535 2338646
Oedema peripheral 109.30 43.85 133 18771 23630 2315551
Pain 108.45 43.85 222 18682 61635 2277546
Congestive cardiomyopathy 106.16 43.85 40 18864 923 2338258
Cellulitis 105.79 43.85 85 18819 9116 2330065
Pulmonary alveolar haemorrhage 105.43 43.85 37 18867 692 2338489
Aphasia 104.19 43.85 66 18838 4862 2334319
Mental status changes 103.87 43.85 69 18835 5513 2333668
Pneumatosis intestinalis 103.72 43.85 32 18872 391 2338790
Hepatomegaly 103.44 43.85 47 18857 1762 2337419
B-cell lymphoma recurrent 102.99 43.85 21 18883 31 2339150
Blood luteinising hormone increased 101.78 43.85 22 18882 50 2339131
Mucormycosis 100.10 43.85 31 18873 384 2338797
Rhinovirus infection 99.98 43.85 29 18875 282 2338899
Premature labour 99.64 43.85 48 18856 2058 2337123
Mitral valve incompetence 99.55 43.85 51 18853 2499 2336682
Bacterial sepsis 99.22 43.85 32 18872 456 2338725
Rash 98.82 43.85 209 18695 59349 2279832
Electrolyte imbalance 98.11 43.85 47 18857 1990 2337191
Upper respiratory tract infection 98.02 43.85 80 18824 8771 2330410
Blood creatinine increased 97.76 43.85 86 18818 10447 2328734
Bone marrow disorder 97.66 43.85 30 18874 361 2338820
Autoimmune haemolytic anaemia 97.60 43.85 35 18869 699 2338482
Chest pain 97.53 43.85 137 18767 28000 2311181
Epistaxis 97.14 43.85 83 18821 9696 2329485
JC virus infection 96.81 43.85 26 18878 185 2338996
Metastasis 96.80 43.85 37 18867 889 2338292
Lung consolidation 96.63 43.85 32 18872 498 2338683
Secondary immunodeficiency 96.17 43.85 22 18882 71 2339110
Fungaemia 96.06 43.85 27 18877 232 2338949
Hemiparesis 95.67 43.85 55 18849 3395 2335786
Skin toxicity 95.09 43.85 35 18869 755 2338426
Hypertransaminasaemia 94.95 43.85 33 18871 599 2338582
Graft versus host disease in gastrointestinal tract 94.66 43.85 27 18877 246 2338935
Chronic myelomonocytic leukaemia 93.93 43.85 22 18882 81 2339100
Intentional product use issue 93.46 43.85 55 18849 3547 2335634
Thrombotic microangiopathy 93.16 43.85 40 18864 1307 2337874
Oesophagitis 92.73 43.85 45 18859 1961 2337220
Hyperglycaemia 92.38 43.85 61 18843 4824 2334357
Leukaemia recurrent 92.24 43.85 26 18878 226 2338955
Oedema 92.09 43.85 82 18822 10121 2329060
Acute leukaemia 91.44 43.85 27 18877 281 2338900
Dysphagia 90.79 43.85 90 18814 12715 2326466
Hypophagia 90.67 43.85 56 18848 3944 2335237
Atelectasis 90.59 43.85 44 18860 1921 2337260
Capillary leak syndrome 90.10 43.85 28 18876 351 2338830
Arthralgia 89.45 43.85 190 18714 54095 2285086
5q minus syndrome 89.21 43.85 19 18885 39 2339142
Coagulopathy 87.74 43.85 49 18855 2860 2336321
Peritonitis 87.71 43.85 47 18857 2527 2336654
Thrombosis 87.55 43.85 76 18828 9068 2330113
Leukaemia cutis 86.02 43.85 17 18887 19 2339162
Idiopathic pneumonia syndrome 86.02 43.85 17 18887 19 2339162
Oral pain 85.86 43.85 51 18853 3346 2335835
Refractory anaemia with an excess of blasts 85.32 43.85 20 18884 74 2339107
Pseudomonas infection 85.19 43.85 36 18868 1130 2338051
Organising pneumonia 84.63 43.85 33 18871 838 2338343
Transaminases increased 83.65 43.85 56 18848 4531 2334650
Escherichia bacteraemia 83.51 43.85 26 18878 328 2338853
Adenoviral hepatitis 81.87 43.85 16 18888 16 2339165
Haematocrit decreased 81.84 43.85 54 18850 4264 2334917
Sinus tachycardia 81.65 43.85 49 18855 3276 2335905
Splenomegaly 81.49 43.85 38 18866 1513 2337668
Gastrointestinal disorder 81.13 43.85 72 18832 8845 2330336
Ileus 80.64 43.85 42 18862 2130 2337051
Ventricular hypokinesia 80.23 43.85 29 18875 593 2338588
Hepatic necrosis 80.20 43.85 34 18870 1076 2338105
Epstein-Barr virus associated lymphoproliferative disorder 80.08 43.85 24 18880 264 2338917
Myalgia 79.93 43.85 113 18791 23220 2315961
Fusarium infection 79.88 43.85 19 18885 76 2339105
Chronic lymphocytic leukaemia 79.62 43.85 28 18876 527 2338654
Cytomegalovirus test positive 79.51 43.85 26 18878 388 2338793
Leukocytosis 78.36 43.85 49 18855 3527 2335654
Blindness 77.83 43.85 49 18855 3569 2335612
Skin infection 77.66 43.85 36 18868 1414 2337767
Pneumonia fungal 77.08 43.85 25 18879 363 2338818
Pulmonary mass 76.58 43.85 39 18865 1887 2337294
Acute myelomonocytic leukaemia 76.54 43.85 17 18887 46 2339135
Non-Hodgkin's lymphoma 76.14 43.85 31 18873 884 2338297
Malnutrition 76.05 43.85 38 18866 1765 2337416
Foetal growth restriction 76.04 43.85 33 18871 1107 2338074
Hepatosplenomegaly 75.90 43.85 26 18878 451 2338730
Liver injury 75.35 43.85 41 18863 2273 2336908
Transplant failure 75.08 43.85 23 18881 274 2338907
Immunosuppression 74.77 43.85 32 18872 1037 2338144
Nephropathy toxic 74.73 43.85 33 18871 1155 2338026
Oligohydramnios 74.70 43.85 31 18873 929 2338252
Meningitis 74.40 43.85 32 18872 1050 2338131
Oesophageal candidiasis 73.99 43.85 28 18876 654 2338527
Confusional state 73.39 43.85 111 18793 24233 2314948
Osteosarcoma 72.95 43.85 16 18888 40 2339141
Therapeutic product effect incomplete 72.77 43.85 73 18831 10458 2328723
Viral haemorrhagic cystitis 72.08 43.85 17 18887 65 2339116
Cytomegalovirus chorioretinitis 71.66 43.85 20 18884 167 2339014
Appendicitis 71.65 43.85 32 18872 1151 2338030
Pneumomediastinum 71.43 43.85 21 18883 215 2338966
Pseudomonal sepsis 71.29 43.85 22 18882 269 2338912
Enteritis 71.02 43.85 31 18873 1055 2338126
Body temperature increased 70.87 43.85 44 18860 3127 2336054
Encephalitis 70.86 43.85 32 18872 1182 2337999
Chronic myeloid leukaemia 70.67 43.85 26 18878 560 2338621
Enterococcal sepsis 70.64 43.85 19 18885 136 2339045
Respiratory syncytial virus infection 70.62 43.85 27 18877 649 2338532
Alveolar soft part sarcoma 70.59 43.85 13 18891 6 2339175
Plasma cell myeloma recurrent 70.41 43.85 23 18881 342 2338839
Urinary tract infection bacterial 70.33 43.85 25 18879 486 2338695
Paraesthesia 69.85 43.85 103 18801 21985 2317196
Granulomatosis with polyangiitis 69.65 43.85 20 18884 187 2338994
Non-Hodgkin's lymphoma recurrent 69.39 43.85 16 18888 54 2339127
Pulmonary hypertension 69.07 43.85 52 18852 5066 2334115
Invasive ductal breast carcinoma 69.02 43.85 29 18875 897 2338284
Alveolar proteinosis 68.56 43.85 17 18887 84 2339097
Skin lesion 68.30 43.85 47 18857 3978 2335203
Osteonecrosis 68.22 43.85 60 18844 7282 2331899
Recurrent cancer 68.18 43.85 22 18882 314 2338867
Infusion related reaction 67.86 43.85 68 18836 9728 2329453
Systemic mycosis 67.40 43.85 18 18886 125 2339056
Diabetes mellitus 67.15 43.85 60 18844 7435 2331746
Deafness 66.83 43.85 40 18864 2661 2336520
Ileus paralytic 66.34 43.85 27 18877 769 2338412
Lymphocyte count decreased 66.03 43.85 43 18861 3320 2335861
Cytomegalovirus colitis 65.98 43.85 21 18883 286 2338895
Clostridium bacteraemia 65.98 43.85 14 18890 28 2339153
Generalised tonic-clonic seizure 64.67 43.85 51 18853 5321 2333860
Metastatic malignant melanoma 64.49 43.85 21 18883 309 2338872
Cerebral infarction 64.17 43.85 47 18857 4390 2334791
Pneumocystis jirovecii infection 63.89 43.85 19 18885 203 2338978
Oropharyngeal pain 63.84 43.85 71 18833 11447 2327734
Anti-Muellerian hormone level decreased 63.83 43.85 13 18891 19 2339162
B-cell lymphoma 63.63 43.85 25 18879 648 2338533
Human bocavirus infection 63.59 43.85 12 18892 8 2339173
Foetal exposure during pregnancy 63.52 43.85 50 18854 5202 2333979
Hypomagnesaemia 63.51 43.85 38 18866 2526 2336655
Acute pulmonary oedema 63.44 43.85 30 18874 1233 2337948
Pulmonary toxicity 63.06 43.85 25 18879 664 2338517
Gastrointestinal haemorrhage 62.73 43.85 73 18831 12362 2326819
Neoplasm malignant 62.71 43.85 49 18855 5044 2334137
Microangiopathic haemolytic anaemia 61.89 43.85 17 18887 133 2339048
Hepatitis E 61.51 43.85 18 18886 181 2339000
Cardiac failure acute 61.33 43.85 28 18876 1061 2338120
Traumatic lung injury 61.31 43.85 20 18884 296 2338885
Gamma-glutamyltransferase increased 60.99 43.85 50 18854 5512 2333669
Refractory cytopenia with multilineage dysplasia 60.62 43.85 13 18891 28 2339153
Escherichia sepsis 60.46 43.85 23 18881 545 2338636
Staphylococcus test positive 60.31 43.85 22 18882 462 2338719
Epstein Barr virus positive mucocutaneous ulcer 60.10 43.85 14 18890 50 2339131
Jugular vein thrombosis 59.97 43.85 21 18883 390 2338791
Richter's syndrome 59.89 43.85 14 18890 51 2339130
Erythema 59.82 43.85 103 18801 25056 2314125
Acute graft versus host disease in liver 59.80 43.85 16 18888 112 2339069
Dyspnoea exertional 59.77 43.85 50 18854 5670 2333511
Enterocolitis infectious 59.33 43.85 18 18886 207 2338974
Klebsiella bacteraemia 58.84 43.85 16 18888 120 2339061
Drug ineffective for unapproved indication 58.42 43.85 38 18866 2928 2336253
Back pain 58.18 43.85 116 18788 31543 2307638
Cardiomegaly 58.02 43.85 35 18869 2361 2336820
Acute graft versus host disease in intestine 57.97 43.85 18 18886 225 2338956
Nephroblastoma 57.96 43.85 12 18892 20 2339161
Mouth ulceration 57.85 43.85 42 18862 3870 2335311
Pancreatitis 57.65 43.85 57 18847 8022 2331159
Cholecystitis 57.57 43.85 34 18870 2206 2336975
Circulatory collapse 57.44 43.85 41 18863 3679 2335502
Cholestasis 57.43 43.85 41 18863 3680 2335501
Cerebral haemorrhage 57.28 43.85 48 18856 5456 2333725
Gastrosplenic fistula 57.14 43.85 10 18894 1 2339180
Cytogenetic abnormality 56.97 43.85 16 18888 137 2339044
Cryptococcosis 56.87 43.85 16 18888 138 2339043
Liver disorder 56.77 43.85 51 18853 6363 2332818
Hypertriglyceridaemia 56.72 43.85 25 18879 871 2338310
Leukaemia 56.36 43.85 24 18880 768 2338413
Gastritis 56.24 43.85 44 18860 4537 2334644
Glioma 55.99 43.85 14 18890 72 2339109
Parainfluenzae virus infection 55.87 43.85 16 18888 148 2339033
Enterobacter infection 55.84 43.85 18 18886 256 2338925
Myeloid leukaemia 55.83 43.85 14 18890 73 2339108
Tricuspid valve incompetence 55.75 43.85 30 18874 1626 2337555
Meningitis cryptococcal 55.45 43.85 17 18887 203 2338978
Encephalitis viral 55.30 43.85 17 18887 205 2338976
Nocardiosis 55.08 43.85 18 18886 268 2338913
Gastroenteritis 54.93 43.85 37 18867 3023 2336158
Refractory cytopenia with unilineage dysplasia 54.87 43.85 15 18889 115 2339066
Plasma cell leukaemia 54.49 43.85 16 18888 163 2339018
Maternal exposure before pregnancy 54.45 43.85 24 18880 836 2338345
Nervous system disorder 54.32 43.85 37 18867 3079 2336102
Ovarian disorder 54.07 43.85 17 18887 222 2338959
Inappropriate antidiuretic hormone secretion 54.04 43.85 33 18871 2276 2336905
Endocarditis 53.95 43.85 23 18881 738 2338443
Pancreatitis acute 53.89 43.85 40 18864 3813 2335368
Pulmonary mycosis 53.56 43.85 15 18889 127 2339054
Bone marrow transplant 53.46 43.85 16 18888 175 2339006
Viral infection 53.31 43.85 43 18861 4633 2334548
Hypercalcaemia 53.00 43.85 34 18870 2558 2336623
Acquired gene mutation 52.75 43.85 15 18889 135 2339046
Haemolysis 52.74 43.85 25 18879 1033 2338148
Haemorrhage 52.69 43.85 63 18841 10976 2328205
Acute hepatitis B 52.62 43.85 12 18892 38 2339143
White blood cell count increased 52.48 43.85 51 18853 7027 2332154
Clonal evolution 52.22 43.85 10 18894 8 2339173
Haemolytic anaemia 52.18 43.85 30 18874 1851 2337330
Myocardial ischaemia 52.10 43.85 32 18872 2230 2336951
Bronchiectasis 51.90 43.85 24 18880 937 2338244
Pseudomonal bacteraemia 51.84 43.85 14 18890 102 2339079
Enterocolitis 51.76 43.85 23 18881 817 2338364
Gastrointestinal necrosis 51.18 43.85 21 18883 611 2338570
Cutaneous calcification 51.17 43.85 10 18894 10 2339171
Fungal skin infection 51.06 43.85 20 18884 514 2338667
Infection reactivation 51.02 43.85 14 18890 109 2339072
Blood immunoglobulin G decreased 50.81 43.85 16 18888 210 2338971
Metastases to skin 50.74 43.85 16 18888 211 2338970
Abdominal compartment syndrome 50.69 43.85 14 18890 112 2339069
Plasmablastic lymphoma 50.65 43.85 12 18892 47 2339134
Tuberculosis of central nervous system 50.45 43.85 12 18892 48 2339133
Liver function test abnormal 50.05 43.85 51 18853 7439 2331742
Myelopathy 49.98 43.85 18 18886 364 2338817
Plasmacytoma 49.88 43.85 18 18886 366 2338815
Clostridium test positive 49.88 43.85 17 18887 290 2338891
Gene mutation 49.88 43.85 15 18889 167 2339014
Escherichia infection 49.85 43.85 26 18878 1322 2337859
Ataxia 49.26 43.85 32 18872 2460 2336721
Human herpesvirus 8 infection 49.20 43.85 11 18893 31 2339150
Acquired haemophilia 49.13 43.85 14 18890 127 2339054
Anaphylactic reaction 48.99 43.85 57 18847 9648 2329533
Low birth weight baby 48.85 43.85 22 18882 807 2338374
Acute coronary syndrome 48.74 43.85 27 18877 1550 2337631
Klebsiella sepsis 48.71 43.85 15 18889 182 2338999
Lymphoproliferative disorder 48.42 43.85 20 18884 592 2338589
Large intestinal ulcer perforation 48.31 43.85 9 18895 5 2339176
Cystitis 48.24 43.85 44 18860 5598 2333583
Fluid overload 48.16 43.85 33 18871 2773 2336408
Cholecystitis acute 47.84 43.85 24 18880 1124 2338057
Streptococcal bacteraemia 47.82 43.85 14 18890 141 2339040
Combined immunodeficiency 47.81 43.85 10 18894 18 2339163
Osteomyelitis bacterial 47.73 43.85 11 18893 37 2339144
Diastolic dysfunction 47.55 43.85 20 18884 620 2338561
Clostridium difficile infection 47.28 43.85 33 18871 2857 2336324
Orthopnoea 47.26 43.85 20 18884 630 2338551
Perineal necrosis 47.11 43.85 9 18895 7 2339174
Hydrocephalus 47.05 43.85 22 18882 881 2338300
Guillain-Barre syndrome 47.02 43.85 20 18884 638 2338543
Perineal infection 46.80 43.85 10 18894 21 2339160
Hepatitis acute 46.68 43.85 26 18878 1509 2337672
Hypoproteinaemia 46.65 43.85 17 18887 356 2338825
HER-2 positive breast cancer 46.58 43.85 12 18892 71 2339110
Productive cough 46.48 43.85 42 18862 5279 2333902
Basedow's disease 46.46 43.85 19 18885 548 2338633
Hypophosphataemia 46.45 43.85 23 18881 1047 2338134
Squamous cell carcinoma 46.40 43.85 25 18879 1358 2337823
Cerebral venous sinus thrombosis 46.21 43.85 17 18887 366 2338815
Appendiceal abscess 46.05 43.85 11 18893 45 2339136
Non-cardiac chest pain 45.67 43.85 21 18883 809 2338372
Pneumonia bacterial 45.51 43.85 22 18882 950 2338231
Mantle cell lymphoma 45.42 43.85 13 18891 120 2339061
Lennox-Gastaut syndrome 45.31 43.85 10 18894 26 2339155
Corynebacterium infection 45.23 43.85 12 18892 81 2339100
Hypersensitivity 45.21 43.85 88 18816 23505 2315676
Dizziness 45.13 43.85 155 18749 58510 2280671
Mesenteric abscess 45.11 43.85 9 18895 11 2339170
Large intestinal ulcer 45.02 43.85 18 18886 489 2338692
Myeloproliferative neoplasm 44.95 43.85 13 18891 125 2339056
Alpha haemolytic streptococcal infection 44.58 43.85 13 18891 129 2339052
Blood alkaline phosphatase increased 44.52 43.85 45 18859 6500 2332681
Bone marrow infiltration 44.42 43.85 11 18893 54 2339127
Brain oedema 44.04 43.85 29 18875 2281 2336900
Premature rupture of membranes 43.92 43.85 21 18883 885 2338296
Brain abscess 43.90 43.85 16 18888 335 2338846

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
Febrile neutropenia 5779.05 47.22 1611 14635 9489 1721046
Neutropenia 2987.58 47.22 1103 15143 17157 1713378
Product use in unapproved indication 1986.25 47.22 689 15557 8733 1721802
Pyrexia 1931.00 47.22 1078 15168 45322 1685213
Off label use 1770.03 47.22 957 15289 37614 1692921
Pneumonia 1611.61 47.22 958 15288 45224 1685311
Sepsis 1355.66 47.22 642 15604 18796 1711739
Myelodysplastic syndrome 1306.15 47.22 390 15856 2899 1727636
Thrombocytopenia 1220.94 47.22 615 15631 20634 1709901
Mucosal inflammation 1121.20 47.22 367 15879 3802 1726733
Pancytopenia 1085.17 47.22 468 15778 10889 1719646
Bone marrow failure 954.40 47.22 344 15902 4856 1725679
Cytomegalovirus infection 945.72 47.22 305 15941 2996 1727539
Anaemia 898.46 47.22 563 15683 28894 1701641
Acute myeloid leukaemia 895.74 47.22 287 15959 2754 1727781
Hepatitis B 894.39 47.22 241 16005 1162 1729373
Leukopenia 873.92 47.22 369 15877 8111 1722424
Septic shock 799.40 47.22 342 15904 7767 1722768
Second primary malignancy 751.19 47.22 198 16048 861 1729674
Multiple organ dysfunction syndrome 743.72 47.22 338 15908 8904 1721631
Infection 740.86 47.22 369 15877 11991 1718544
Haematotoxicity 717.38 47.22 187 16059 771 1729764
Progressive multifocal leukoencephalopathy 696.22 47.22 205 16041 1434 1729101
Respiratory failure 687.91 47.22 370 15876 14135 1716400
Pneumocystis jirovecii pneumonia 674.90 47.22 220 16026 2236 1728299
Neutropenic sepsis 644.16 47.22 189 16057 1303 1729232
Febrile bone marrow aplasia 602.76 47.22 160 16086 718 1729817
White blood cell count decreased 602.56 47.22 328 15918 12821 1717714
Drug ineffective 587.30 47.22 603 15643 63198 1667337
Platelet count decreased 550.81 47.22 335 15911 16188 1714347
Neutrophil count decreased 548.19 47.22 241 16005 5840 1724695
Disease progression 529.69 47.22 332 15914 16931 1713604
Diffuse large B-cell lymphoma 513.68 47.22 149 16097 980 1729555
Venoocclusive liver disease 509.54 47.22 142 16104 791 1729744
Tumour lysis syndrome 497.75 47.22 161 16085 1590 1728945
Graft versus host disease 442.23 47.22 143 16103 1410 1729125
Cystitis haemorrhagic 436.37 47.22 117 16129 549 1729986
Acute kidney injury 435.12 47.22 391 15855 34553 1695982
Bronchopulmonary aspergillosis 428.87 47.22 140 16106 1426 1729109
Malignant neoplasm progression 405.78 47.22 261 15985 13897 1716638
Hypogammaglobulinaemia 389.28 47.22 106 16140 533 1730002
Neuropathy peripheral 374.63 47.22 213 16033 9040 1721495
Lymphopenia 374.21 47.22 135 16111 1898 1728637
Aspergillus infection 368.90 47.22 121 16125 1252 1729283
Hypotension 365.21 47.22 330 15916 29324 1701211
Acute graft versus host disease 359.74 47.22 106 16140 741 1729794
Diarrhoea 357.51 47.22 430 15816 53422 1677113
Cytomegalovirus chorioretinitis 349.32 47.22 88 16158 305 1730230
Epstein-Barr virus infection 346.56 47.22 110 16136 1015 1729520
Pleural effusion 343.59 47.22 215 16031 10895 1719640
Vomiting 343.33 47.22 358 15888 37957 1692578
Renal failure 341.64 47.22 269 15977 19748 1710787
Haemophagocytic lymphohistiocytosis 333.99 47.22 114 16132 1346 1729189
Hepatitis B reactivation 330.19 47.22 84 16162 306 1730229
Posterior reversible encephalopathy syndrome 328.95 47.22 113 16133 1362 1729173
Cytokine release syndrome 322.72 47.22 89 16157 473 1730062
Alanine aminotransferase increased 314.25 47.22 211 16035 12067 1718468
Colitis 310.92 47.22 145 16101 4035 1726500
Stomatitis 304.40 47.22 155 16091 5249 1725286
Venoocclusive disease 296.79 47.22 76 16170 286 1730249
Pulmonary embolism 281.57 47.22 202 16044 12857 1717678
Adenovirus infection 278.57 47.22 76 16170 385 1730150
Dyspnoea 272.92 47.22 370 15876 51689 1678846
Acute graft versus host disease in skin 271.26 47.22 78 16168 494 1730041
Disease recurrence 270.75 47.22 114 16132 2468 1728067
Pneumonitis 264.14 47.22 127 16119 3788 1726747
Diffuse large B-cell lymphoma recurrent 263.45 47.22 57 16189 75 1730460
Interstitial lung disease 260.97 47.22 172 16074 9524 1721011
Nausea 257.93 47.22 357 15889 50839 1679696
Haemoglobin decreased 251.69 47.22 211 16035 16903 1713632
Agranulocytosis 244.26 47.22 117 16129 3459 1727076
Lower respiratory tract infection 239.00 47.22 118 16128 3733 1726802
Chills 236.45 47.22 174 16072 11513 1719022
General physical health deterioration 235.90 47.22 182 16064 12936 1717599
Product use issue 235.38 47.22 154 16092 8417 1722118
Herpes zoster 233.98 47.22 123 16123 4450 1726085
Abdominal pain 232.91 47.22 223 16023 21267 1709268
Lung infiltration 231.96 47.22 97 16149 2062 1728473
Hypoxia 229.73 47.22 133 16113 5830 1724705
Chronic graft versus host disease 228.91 47.22 68 16178 490 1730045
BK virus infection 221.39 47.22 64 16182 414 1730121
Hepatotoxicity 220.08 47.22 104 16142 2980 1727555
Bacteraemia 217.30 47.22 89 16157 1791 1728744
Plasma cell myeloma 215.96 47.22 155 16091 9859 1720676
Lymphadenopathy 211.44 47.22 111 16135 4003 1726532
Candida infection 210.44 47.22 88 16158 1870 1728665
Device related infection 210.23 47.22 92 16154 2194 1728341
Atrial fibrillation 209.18 47.22 180 16066 14931 1715604
Cardiac failure 203.22 47.22 164 16082 12438 1718097
Cough 201.89 47.22 196 16050 19001 1711534
Herpes simplex 201.12 47.22 65 16181 638 1729897
Post transplant lymphoproliferative disorder 201.01 47.22 66 16180 684 1729851
Staphylococcal infection 197.42 47.22 111 16135 4596 1725939
Hepatic failure 196.92 47.22 120 16126 5783 1724752
Neurotoxicity 191.15 47.22 83 16163 1941 1728594
Ascites 190.04 47.22 115 16131 5471 1725064
Hyperbilirubinaemia 187.73 47.22 85 16161 2202 1728333
Neoplasm progression 187.64 47.22 95 16151 3172 1727363
Cytopenia 186.68 47.22 66 16180 870 1729665
Stem cell transplant 178.96 47.22 54 16192 413 1730122
Condition aggravated 178.84 47.22 192 16054 20958 1709577
Bacterial sepsis 176.73 47.22 58 16188 600 1729935
Pseudomonas infection 175.87 47.22 69 16177 1235 1729300
Decreased appetite 173.14 47.22 200 16046 23671 1706864
Blood bilirubin increased 171.45 47.22 112 16134 6098 1724437
B-cell lymphoma 170.95 47.22 60 16186 773 1729762
Encephalopathy 170.63 47.22 99 16147 4353 1726182
Escherichia sepsis 169.46 47.22 56 16190 593 1729942
Polyneuropathy 169.09 47.22 73 16173 1682 1728853
Drug resistance 165.53 47.22 87 16159 3143 1727392
Aspartate aminotransferase increased 164.99 47.22 136 16110 10620 1719915
Cardiotoxicity 163.67 47.22 58 16188 770 1729765
Klebsiella infection 160.76 47.22 57 16189 758 1729777
Staphylococcal sepsis 158.73 47.22 63 16183 1164 1729371
Muscular weakness 155.96 47.22 129 16117 10120 1720415
Dehydration 155.77 47.22 164 16082 17494 1713041
Thrombotic microangiopathy 155.44 47.22 63 16183 1232 1729303
Asthenia 155.33 47.22 229 16017 34441 1696094
Hodgkin's disease 155.21 47.22 55 16191 730 1729805
Escherichia infection 153.39 47.22 58 16188 935 1729600
Acute lymphocytic leukaemia 152.97 47.22 50 16196 510 1730025
Respiratory distress 152.18 47.22 97 16149 5060 1725475
Aplasia 150.02 47.22 47 16199 413 1730122
Deep vein thrombosis 149.15 47.22 124 16122 9796 1720739
Therapy non-responder 148.96 47.22 103 16143 6163 1724372
Pneumonia cytomegaloviral 148.92 47.22 45 16201 346 1730189
Osteonecrosis 148.90 47.22 87 16159 3875 1726660
Fungal infection 148.34 47.22 72 16174 2190 1728345
Mantle cell lymphoma recurrent 146.32 47.22 31 16215 34 1730501
Hyponatraemia 144.74 47.22 117 16129 8883 1721652
Clostridium difficile colitis 142.44 47.22 63 16183 1541 1728994
Acute lymphocytic leukaemia recurrent 142.36 47.22 41 16205 261 1730274
Transplant failure 142.15 47.22 44 16202 370 1730165
Skin toxicity 137.83 47.22 47 16199 552 1729983
Hypertriglyceridaemia 135.50 47.22 56 16190 1153 1729382
Fatigue 135.23 47.22 266 15980 50515 1680020
Systemic mycosis 134.95 47.22 35 16211 140 1730395
Therapeutic response decreased 134.48 47.22 92 16154 5408 1725127
JC virus infection 133.14 47.22 36 16210 175 1730360
Urinary tract infection 132.43 47.22 117 16129 10036 1720499
Bone marrow toxicity 131.20 47.22 40 16206 318 1730217
Treatment failure 130.39 47.22 83 16163 4318 1726217
Cytogenetic abnormality 129.60 47.22 36 16210 197 1730338
Plasmacytoma 129.21 47.22 43 16203 466 1730069
Graft versus host disease in skin 128.36 47.22 41 16205 386 1730149
Oedema 128.26 47.22 98 16148 6850 1723685
Epstein-Barr virus associated lymphoproliferative disorder 128.14 47.22 39 16207 308 1730227
Mucormycosis 127.68 47.22 47 16199 700 1729835
Acute respiratory distress syndrome 125.63 47.22 75 16171 3476 1727059
Cellulitis 125.52 47.22 94 16152 6374 1724161
Richter's syndrome 123.55 47.22 31 16215 105 1730430
Hypokalaemia 122.28 47.22 92 16154 6282 1724253
Enterococcal infection 119.12 47.22 47 16199 854 1729681
Transaminases increased 118.85 47.22 75 16171 3842 1726693
Graft versus host disease in gastrointestinal tract 117.37 47.22 38 16208 375 1730160
Splenomegaly 116.92 47.22 60 16186 2060 1728475
Tachycardia 114.35 47.22 119 16127 12509 1718026
Lymphoproliferative disorder 112.46 47.22 38 16208 433 1730102
Hepatitis 112.03 47.22 79 16167 4876 1725659
Strongyloidiasis 111.84 47.22 37 16209 393 1730142
Hepatomegaly 111.58 47.22 54 16192 1631 1728904
Renal impairment 111.43 47.22 116 16130 12198 1718337
Acute graft versus host disease in intestine 111.32 47.22 34 16212 272 1730263
Intentional product use issue 110.93 47.22 63 16183 2656 1727879
B-cell lymphoma recurrent 110.80 47.22 25 16221 45 1730490
Cardiomyopathy 110.23 47.22 63 16183 2689 1727846
Neutropenic colitis 109.50 47.22 33 16213 251 1730284
Arrhythmia 109.15 47.22 84 16162 5932 1724603
Constipation 107.48 47.22 125 16121 14875 1715660
Acute hepatic failure 107.42 47.22 56 16190 1987 1728548
Peripheral sensory neuropathy 107.16 47.22 43 16203 818 1729717
Burkitt's lymphoma 106.04 47.22 28 16218 122 1730413
C-reactive protein increased 104.22 47.22 81 16165 5804 1724731
Disseminated intravascular coagulation 104.17 47.22 67 16179 3547 1726988
Pseudomonal sepsis 103.64 47.22 34 16212 351 1730184
Dysphagia 103.33 47.22 102 16144 10066 1720469
Leukoencephalopathy 103.20 47.22 41 16205 759 1729776
Intestinal perforation 101.55 47.22 50 16196 1569 1728966
Infection reactivation 101.05 47.22 26 16220 100 1730435
Lymphoma 100.77 47.22 54 16192 2028 1728507
Gastrointestinal haemorrhage 100.72 47.22 118 16128 14149 1716386
Lung disorder 100.66 47.22 75 16171 5044 1725491
Nervous system disorder 100.49 47.22 57 16189 2397 1728138
Central nervous system lymphoma 100.22 47.22 28 16218 157 1730378
Viral haemorrhagic cystitis 99.65 47.22 24 16222 65 1730470
Pulmonary fibrosis 99.42 47.22 57 16189 2447 1728088
Pneumonia fungal 99.34 47.22 35 16211 456 1730079
Aphasia 96.89 47.22 63 16183 3398 1727137
Toxicity to various agents 95.38 47.22 167 16079 28974 1701561
Weight decreased 94.19 47.22 145 16101 22608 1707927
Blood culture positive 93.73 47.22 38 16208 743 1729792
Staphylococcal bacteraemia 93.31 47.22 38 16208 752 1729783
Neoplasm recurrence 93.13 47.22 32 16214 385 1730150
Chronic lymphocytic leukaemia 92.85 47.22 39 16207 837 1729698
Nephropathy toxic 92.56 47.22 48 16198 1684 1728851
Microsporidia infection 92.30 47.22 21 16225 40 1730495
Guillain-Barre syndrome 91.30 47.22 39 16207 874 1729661
Sinusitis 90.55 47.22 71 16175 5152 1725383
Pneumothorax 90.04 47.22 55 16191 2657 1727878
Seizure 89.89 47.22 134 16112 20307 1710228
Acquired gene mutation 89.80 47.22 26 16220 169 1730366
Blood creatinine increased 89.66 47.22 110 16136 13836 1716699
Myelitis transverse 89.41 47.22 26 16220 172 1730363
Bacterial infection 88.34 47.22 48 16198 1854 1728681
Therapeutic product effect incomplete 87.91 47.22 71 16175 5377 1725158
Acute graft versus host disease in liver 87.36 47.22 25 16221 155 1730380
Syncope 86.67 47.22 109 16137 14060 1716475
Cytomegalovirus test positive 86.23 47.22 32 16214 488 1730047
Atelectasis 84.83 47.22 47 16199 1887 1728648
Oesophagitis 84.81 47.22 45 16201 1656 1728879
Haematuria 84.63 47.22 80 16166 7480 1723055
Neutrophil count increased 84.58 47.22 52 16194 2541 1727994
Drug ineffective for unapproved indication 84.51 47.22 46 16200 1783 1728752
Streptococcal infection 84.47 47.22 34 16212 652 1729883
Pulmonary toxicity 84.43 47.22 36 16210 803 1729732
Chronic graft versus host disease in skin 84.23 47.22 22 16224 91 1730444
Refractory anaemia with an excess of blasts 83.85 47.22 22 16224 93 1730442
Cerebral toxoplasmosis 83.43 47.22 24 16222 152 1730383
Immunosuppression 83.41 47.22 36 16210 828 1729707
Kaposi's sarcoma 83.29 47.22 36 16210 831 1729704
Cytomegalovirus viraemia 83.26 47.22 32 16214 540 1729995
Encephalitis 83.06 47.22 39 16207 1099 1729436
Clostridium difficile infection 82.86 47.22 45 16201 1736 1728799
Blood lactate dehydrogenase increased 81.69 47.22 58 16188 3617 1726918
Neutropenic infection 81.01 47.22 23 16223 138 1730397
Klebsiella sepsis 80.88 47.22 25 16221 209 1730326
Sinus tachycardia 80.62 47.22 50 16196 2482 1728053
Autoimmune haemolytic anaemia 80.55 47.22 34 16212 739 1729796
Acute promyelocytic leukaemia 80.31 47.22 23 16223 143 1730392
Human herpesvirus 6 infection 79.87 47.22 28 16218 359 1730176
Respiratory tract infection fungal 79.80 47.22 21 16225 90 1730445
Pulmonary haemorrhage 79.24 47.22 43 16203 1656 1728879
Chronic lymphocytic leukaemia recurrent 78.76 47.22 20 16226 72 1730463
Oedema peripheral 78.69 47.22 109 16137 15441 1715094
Dysarthria 77.45 47.22 65 16181 5194 1725341
Non-Hodgkin's lymphoma 77.13 47.22 35 16211 910 1729625
Refractory cytopenia with multilineage dysplasia 77.06 47.22 17 16229 26 1730509
Pulmonary alveolar haemorrhage 76.12 47.22 37 16209 1128 1729407
Upper respiratory tract infection 76.09 47.22 58 16188 4035 1726500
Blindness 76.07 47.22 50 16196 2746 1727789
Pneumatosis intestinalis 75.26 47.22 29 16217 493 1730042
Confusional state 74.90 47.22 126 16120 21152 1709383
Pneumocystis jirovecii infection 74.61 47.22 25 16221 277 1730258
Influenza 72.68 47.22 70 16176 6697 1723838
Sweat gland tumour 72.65 47.22 18 16228 57 1730478
T-cell lymphoma 72.62 47.22 23 16223 210 1730325
Encephalitis enteroviral 72.15 47.22 14 16232 5 1730530
Contraindicated product administered 71.42 47.22 38 16208 1406 1729129
Glioblastoma multiforme 71.30 47.22 23 16223 224 1730311
Peripheral T-cell lymphoma unspecified 71.16 47.22 20 16226 115 1730420
Nocardiosis 71.04 47.22 28 16218 507 1730028
Ejection fraction decreased 70.63 47.22 44 16202 2201 1728334
Headache 70.35 47.22 162 16084 34214 1696321
Parainfluenzae virus infection 70.24 47.22 22 16224 193 1730342
Plasma cell myeloma recurrent 70.06 47.22 27 16219 459 1730076
Systemic candida 69.71 47.22 25 16221 344 1730191
Oral candidiasis 69.15 47.22 36 16210 1273 1729262
Hyperglycaemia 68.25 47.22 60 16186 5105 1725430
Hypoalbuminaemia 68.23 47.22 37 16209 1423 1729112
Mass 67.97 47.22 34 16212 1104 1729431
Hemiparesis 67.43 47.22 46 16200 2688 1727847
Squamous cell carcinoma 67.42 47.22 40 16206 1831 1728704
Pericardial effusion 67.37 47.22 50 16196 3340 1727195
Cerebral aspergillosis 67.19 47.22 20 16226 145 1730390
Chloroma 66.99 47.22 18 16228 85 1730450
Lymphocyte count decreased 66.44 47.22 42 16204 2156 1728379
Left ventricular dysfunction 65.97 47.22 34 16212 1177 1729358
Bronchitis 65.65 47.22 60 16186 5372 1725163
Cholecystitis 65.49 47.22 37 16209 1543 1728992
Peritonitis 64.99 47.22 45 16201 2694 1727841
White blood cell count increased 64.52 47.22 68 16178 7244 1723291
Basal cell carcinoma 64.16 47.22 43 16203 2440 1728095
Febrile infection 63.90 47.22 20 16226 175 1730360
Ataxia 63.82 47.22 42 16204 2311 1728224
Paraesthesia 63.25 47.22 80 16166 10371 1720164
Traumatic lung injury 63.04 47.22 22 16224 278 1730257
Myeloid leukaemia 62.97 47.22 17 16229 82 1730453
Clostridium colitis 62.48 47.22 21 16225 235 1730300
Pneumomediastinum 61.86 47.22 22 16224 295 1730240
Hypofibrinogenaemia 61.70 47.22 20 16226 198 1730337
Hypertension 61.68 47.22 110 16136 19338 1711197
Escherichia bacteraemia 61.52 47.22 22 16224 300 1730235
Fluid overload 61.45 47.22 39 16207 2016 1728519
Skin infection 61.25 47.22 30 16216 930 1729605
H1N1 influenza 61.00 47.22 20 16226 206 1730329
Cardiac arrest 60.98 47.22 98 16148 15832 1714703
Facial paresis 60.92 47.22 24 16222 434 1730101
West Nile viral infection 60.74 47.22 17 16229 96 1730439
Gastrointestinal toxicity 60.73 47.22 23 16223 372 1730163
Deafness 60.51 47.22 38 16208 1928 1728607
Small intestinal obstruction 60.51 47.22 37 16209 1790 1728745
Glioma 59.81 47.22 16 16230 74 1730461
Death 59.60 47.22 283 15963 87160 1643375
Skin lesion 59.43 47.22 44 16202 2928 1727607
Respiratory tract infection 59.25 47.22 41 16205 2452 1728083
Pneumonia klebsiella 59.01 47.22 22 16224 340 1730195
Metastasis 58.95 47.22 28 16218 810 1729725
Body temperature increased 58.91 47.22 42 16204 2635 1727900
Hepatosplenic candidiasis 58.49 47.22 13 16233 21 1730514
Erythroleukaemia 58.49 47.22 13 16233 21 1730514
Therapy partial responder 58.29 47.22 21 16225 293 1730242
Pain 58.26 47.22 129 16117 26528 1704007
Primary hypogonadism 57.84 47.22 14 16232 39 1730496
Cystitis viral 57.84 47.22 14 16232 39 1730496
Premature baby 57.58 47.22 43 16203 2899 1727636
Palmar-plantar erythrodysaesthesia syndrome 57.19 47.22 46 16200 3461 1727074
Embolism 56.95 47.22 30 16216 1087 1729448
Gastrointestinal disorder 56.50 47.22 52 16194 4696 1725839
Pulmonary mass 56.19 47.22 32 16214 1355 1729180
Foetal exposure during pregnancy 55.86 47.22 59 16187 6300 1724235
Systemic inflammatory response syndrome 55.66 47.22 27 16219 819 1729716
5q minus syndrome 55.44 47.22 14 16232 49 1730486
Plasmablastic lymphoma 54.58 47.22 14 16232 53 1730482
T-cell lymphoma stage IV 54.53 47.22 12 16234 18 1730517
Pulmonary oedema 54.14 47.22 59 16187 6527 1724008
Haemolysis 53.22 47.22 29 16217 1126 1729409
Neuralgia 53.21 47.22 31 16215 1371 1729164
Enterovesical fistula 53.12 47.22 17 16229 161 1730374
Chronic myelomonocytic leukaemia 53.03 47.22 17 16229 162 1730373
Osteoporosis 52.80 47.22 32 16214 1523 1729012
Oesophageal candidiasis 52.65 47.22 23 16223 545 1729990
Meningitis cryptococcal 52.61 47.22 20 16226 327 1730208
Liver disorder 52.56 47.22 54 16192 5582 1724953
Erysipelas 52.23 47.22 25 16221 736 1729799
Bone marrow disorder 52.17 47.22 20 16226 335 1730200
Leukaemia recurrent 51.79 47.22 19 16227 280 1730255
Hepatitis viral 51.42 47.22 16 16230 137 1730398
Circulatory collapse 51.35 47.22 43 16203 3424 1727111
Small intestinal perforation 51.15 47.22 20 16226 354 1730181
Lung consolidation 51.07 47.22 23 16223 587 1729948
Chronic lymphocytic leukaemia refractory 51.03 47.22 11 16235 14 1730521
Nasal cavity cancer 50.80 47.22 12 16234 29 1730506
Oropharyngeal pain 50.15 47.22 49 16197 4769 1725766
Cerebral haemorrhage 49.46 47.22 55 16191 6222 1724313
Epistaxis 49.33 47.22 63 16183 8243 1722292
Fusarium infection 49.33 47.22 15 16231 118 1730417
Haematopoietic stem cell mobilisation 49.29 47.22 10 16236 7 1730528
Cholestasis 49.27 47.22 43 16203 3622 1726913
Mental status changes 49.20 47.22 54 16192 6021 1724514
Pulmonary veno-occlusive disease 49.03 47.22 14 16232 86 1730449
Enterococcal sepsis 48.35 47.22 16 16230 170 1730365
Organising pneumonia 48.30 47.22 25 16221 873 1729662
Abdominal distension 48.28 47.22 55 16191 6389 1724146
Hepatic encephalopathy 48.24 47.22 35 16211 2257 1728278
Haemoptysis 47.81 47.22 48 16198 4828 1725707
Acute monocytic leukaemia 47.74 47.22 12 16234 41 1730494
Peripheral motor neuropathy 47.46 47.22 17 16229 233 1730302
Pleuritic pain 47.40 47.22 20 16226 434 1730101
Tachypnoea 47.35 47.22 35 16211 2323 1728212

Pharmacologic Action:

SourceCodeDescription
ATC L01AA01 ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
ANTINEOPLASTIC AGENTS
ALKYLATING AGENTS
Nitrogen mustard analogues
MeSH PA D000477 Alkylating Agents
CHEBI has role CHEBI:35610 antineoplastic agent
CHEBI has role CHEBI:35705 immunosuppressive agent
MeSH PA D000970 Antineoplastic Agents
MeSH PA D018906 Antineoplastic Agents, Alkylating
MeSH PA D018501 Antirheumatic Agents
MeSH PA D007155 Immunologic Factors
MeSH PA D007166 Immunosuppressive Agents
MeSH PA D009153 Mutagens
MeSH PA D019653 Myeloablative Agonists
MeSH PA D009676 Noxae

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Multiple myeloma indication 109989006 DOID:9538
Malignant lymphoma indication 118600007 DOID:0060058
Mycosis fungoides indication 118618005
Carcinoma of breast indication 254838004 DOID:3459
Retinoblastoma indication 370967009 DOID:768
Neuroblastoma indication 432328008 DOID:769

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 2.39 Basic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Cytochrome P450 3A4 Enzyme IC50 5.68 WOMBAT-PK
DNA DNA OTHER CHEMBL CHEMBL

External reference:

IDSource
D003520 MESH_DESCRIPTOR_UI
4018114 VUID
N0000146452 NUI
C0010583 UMLSCUI
D00287 KEGG_DRUG
74470007 SNOMEDCT_US
4018114 VANDF
002631 NDDF
31952 MMSL
3002 RXNORM
387420009 SNOMEDCT_US
4519 MMSL
d00036 MMSL
8N3DW7272P UNII
6055-19-2 SECONDARY_CAS_RN
CHEBI:4026 CHEBI
CHEMBL88 ChEMBL_ID
DB00531 DRUGBANK_ID
CHEMBL1200796 ChEMBL_ID
7154 IUPHAR_LIGAND_ID
2907 PUBCHEM_CID

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Cyclophosphamide HUMAN PRESCRIPTION DRUG LABEL 1 0054-0382 CAPSULE 25 mg ORAL NDA 17 sections
Cyclophosphamide HUMAN PRESCRIPTION DRUG LABEL 1 0054-0383 CAPSULE 50 mg ORAL NDA 17 sections
Cyclophosphamide HUMAN PRESCRIPTION DRUG LABEL 1 0781-3233 INJECTION, POWDER, FOR SOLUTION 500 mg INTRAVENOUS ANDA 17 sections
Cyclophosphamide HUMAN PRESCRIPTION DRUG LABEL 1 0781-3244 INJECTION, POWDER, FOR SOLUTION 1 g INTRAVENOUS ANDA 17 sections
Cyclophosphamide HUMAN PRESCRIPTION DRUG LABEL 1 0781-3255 INJECTION, POWDER, FOR SOLUTION 2 g ORAL ANDA 17 sections
CYCLOPHOSPHAMIDE HUMAN PRESCRIPTION DRUG LABEL 1 10019-935 INJECTION, POWDER, FOR SOLUTION 500 mg INTRAVENOUS ANDA 17 sections
CYCLOPHOSPHAMIDE HUMAN PRESCRIPTION DRUG LABEL 1 10019-936 INJECTION, POWDER, FOR SOLUTION 1 g INTRAVENOUS ANDA 17 sections
CYCLOPHOSPHAMIDE HUMAN PRESCRIPTION DRUG LABEL 1 10019-937 INJECTION, POWDER, FOR SOLUTION 2 g INTRAVENOUS ANDA 17 sections
CYCLOPHOSPHAMIDE HUMAN PRESCRIPTION DRUG LABEL 1 10019-938 INJECTION, POWDER, FOR SOLUTION 500 mg INTRAVENOUS ANDA 16 sections
CYCLOPHOSPHAMIDE HUMAN PRESCRIPTION DRUG LABEL 1 10019-939 INJECTION, POWDER, FOR SOLUTION 1 g INTRAVENOUS ANDA 16 sections
CYCLOPHOSPHAMIDE HUMAN PRESCRIPTION DRUG LABEL 1 10019-942 INJECTION, POWDER, FOR SOLUTION 2 g INTRAVENOUS ANDA 16 sections
CYCLOPHOSPHAMIDE HUMAN PRESCRIPTION DRUG LABEL 1 10019-943 INJECTION, POWDER, FOR SOLUTION 500 mg INTRAVENOUS ANDA 17 sections
CYCLOPHOSPHAMIDE HUMAN PRESCRIPTION DRUG LABEL 1 10019-944 INJECTION, POWDER, FOR SOLUTION 1 g INTRAVENOUS ANDA 17 sections
CYCLOPHOSPHAMIDE HUMAN PRESCRIPTION DRUG LABEL 1 10019-945 INJECTION, POWDER, FOR SOLUTION 2 g INTRAVENOUS ANDA 17 sections
Cyclophosphamide HUMAN PRESCRIPTION DRUG LABEL 1 10019-955 INJECTION, POWDER, FOR SOLUTION 500 mg INTRAVENOUS ANDA 16 sections
Cyclophosphamide HUMAN PRESCRIPTION DRUG LABEL 1 10019-956 INJECTION, POWDER, FOR SOLUTION 1 g INTRAVENOUS ANDA 16 sections
Cyclophosphamide HUMAN PRESCRIPTION DRUG LABEL 1 10019-957 INJECTION, POWDER, FOR SOLUTION 2 g INTRAVENOUS ANDA 16 sections
Cyclophosphamide HUMAN PRESCRIPTION DRUG LABEL 1 16714-857 INJECTION, POWDER, FOR SOLUTION 1 g INTRAVENOUS ANDA 17 sections
Cyclophosphamide HUMAN PRESCRIPTION DRUG LABEL 1 16714-858 INJECTION, POWDER, FOR SOLUTION 2 g ORAL ANDA 17 sections
Cyclophosphamide HUMAN PRESCRIPTION DRUG LABEL 1 16714-859 INJECTION, POWDER, FOR SOLUTION 500 mg INTRAVENOUS ANDA 17 sections
CYCLOPHOSPHAMIDE HUMAN PRESCRIPTION DRUG LABEL 1 43975-307 CAPSULE 25 mg ORAL ANDA 17 sections
CYCLOPHOSPHAMIDE HUMAN PRESCRIPTION DRUG LABEL 1 43975-308 CAPSULE 50 mg ORAL ANDA 17 sections
Cyclophosphamide HUMAN PRESCRIPTION DRUG LABEL 1 54868-5005 TABLET 50 mg ORAL ANDA 12 sections
Cyclophosphamide HUMAN PRESCRIPTION DRUG LABEL 1 54868-5218 TABLET 25 mg ORAL ANDA 12 sections
CYCLOPHOSPHAMIDE HUMAN PRESCRIPTION DRUG LABEL 1 54879-021 CAPSULE 25 mg ORAL ANDA 16 sections
CYCLOPHOSPHAMIDE HUMAN PRESCRIPTION DRUG LABEL 1 54879-022 CAPSULE 50 mg ORAL ANDA 16 sections
Cyclophosphamide HUMAN PRESCRIPTION DRUG LABEL 1 68001-370 INJECTION, POWDER, FOR SOLUTION 500 mg INTRAVENOUS ANDA 16 sections
Cyclophosphamide HUMAN PRESCRIPTION DRUG LABEL 1 68001-371 INJECTION, POWDER, FOR SOLUTION 1 g INTRAVENOUS ANDA 16 sections
Cyclophosphamide HUMAN PRESCRIPTION DRUG LABEL 1 68001-372 INJECTION, POWDER, FOR SOLUTION 2 g INTRAVENOUS ANDA 16 sections
Cyclophosphamide HUMAN PRESCRIPTION DRUG LABEL 1 70121-1238 INJECTION, POWDER, FOR SOLUTION 500 mg INTRAVENOUS ANDA 16 sections