temozolomide ๐Ÿถ Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
2589 85622-93-1

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • temomedac
  • SCH 52365
  • temozolomide
  • methazolastone
  • temodal
  • temozolamide
Temozolomide is not directly active but undergoes rapid nonenzymatic conversion at physiologic pH to the reactive compound 5-(3-methyltriazen1-yl)-imidazole-4-carboxamide (MTIC). The cytotoxicity of MTIC is thought to be primarily due to alkylation of DNA.
  • Molecular weight: 194.15
  • Formula: C6H6N6O2
  • CLOGP: -0.81
  • LIPINSKI: 0
  • HAC: 8
  • HDO: 1
  • TPSA: 105.94
  • ALOGS: -1.58
  • ROTB: 1

  • Status: OFP

  • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

None

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 2 Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 5.60 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 25.46 ยตM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 96 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution) 0.50 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 3.60 mL/min/kg Lombardo F, Berellini G, Obach RS
t_half (Half-life) 1.50 hours Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
Aug. 11, 1999 FDA MERCK SHARP DOHME
July 26, 2007 PMDA Schering-Plough K.K.

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
Thrombocytopenia 553.74 20.27 409 16890 127264 50460561
Disease progression 505.11 20.27 346 16953 95520 50492305
Tumour pseudoprogression 318.58 20.27 57 17242 173 50587652
Malignant neoplasm progression 305.26 20.27 223 17076 67901 50519924
Pancytopenia 299.51 20.27 240 17059 83790 50504035
Product use in unapproved indication 208.27 20.27 226 17073 115593 50472232
Bone marrow failure 202.55 20.27 123 17176 27501 50560324
Hypermutation 200.10 20.27 30 17269 11 50587814
Platelet count decreased 176.57 20.27 194 17105 100532 50487293
Seizure 167.94 20.27 204 17095 117670 50470155
Off label use 154.56 20.27 431 16868 473995 50113830
Lymphopenia 144.76 20.27 81 17218 15540 50572285
Death 138.22 20.27 327 16972 325052 50262773
Myelosuppression 136.00 20.27 74 17225 13443 50574382
Metastases to liver 133.32 20.27 84 17215 20020 50567805
Neoplasm progression 122.63 20.27 92 17207 29065 50558760
Febrile neutropenia 113.71 20.27 153 17146 97514 50490311
Haematotoxicity 110.57 20.27 54 17245 7841 50579984
Neutropenia 98.28 20.27 179 17120 147786 50440039
Aplastic anaemia 96.95 20.27 49 17250 7654 50580171
Brain oedema 90.40 20.27 55 17244 12315 50575510
Disease recurrence 79.20 20.27 61 17238 20020 50567805
Leukopenia 78.86 20.27 106 17193 67422 50520403
Hospice care 76.41 20.27 38 17261 5734 50582091
Herpes simplex encephalitis 74.43 20.27 18 17281 294 50587531
Glioblastoma multiforme 72.12 20.27 21 17278 717 50587108
Hemiparesis 64.39 20.27 54 17245 19994 50567831
Joint swelling 62.20 20.27 6 17293 245280 50342545
Radiation necrosis 57.90 20.27 15 17284 328 50587497
Angina bullosa haemorrhagica 54.01 20.27 12 17287 132 50587693
Malignant glioma 49.83 20.27 8 17291 9 50587816
Pulmonary embolism 49.34 20.27 108 17191 101596 50486229
Central nervous system necrosis 48.94 20.27 11 17288 128 50587697
Nausea 48.53 20.27 408 16891 704990 49882835
Metastases to central nervous system 48.30 20.27 36 17263 11246 50576579
White blood cell count decreased 45.74 20.27 114 17185 116608 50471217
Neoplasm recurrence 44.95 20.27 20 17279 2349 50585476
Metastases to peritoneum 44.59 20.27 21 17278 2812 50585013
Brain neoplasm malignant 44.00 20.27 15 17284 862 50586963
Magnetic resonance imaging head abnormal 43.62 20.27 18 17281 1759 50586066
Muscle swelling 42.14 20.27 12 17287 378 50587447
Arthralgia 42.11 20.27 53 17246 438649 50149176
Glioblastoma 42.08 20.27 14 17285 746 50587079
Brain neoplasm 41.71 20.27 22 17277 3751 50584074
Crystal nephropathy 41.12 20.27 14 17285 801 50587024
Ascites 39.87 20.27 55 17244 35806 50552019
Facial asymmetry 39.82 20.27 13 17286 653 50587172
Vomiting 38.46 20.27 279 17020 460479 50127346
Ganglioneuroma 38.05 20.27 9 17290 133 50587692
Early satiety 37.93 20.27 13 17286 759 50587066
Mental status changes 37.90 20.27 54 17245 36218 50551607
Jaw operation 37.80 20.27 13 17286 767 50587058
Pneumocystis jirovecii pneumonia 36.13 20.27 34 17265 14629 50573196
Enterocutaneous fistula 36.02 20.27 14 17285 1170 50586655
Metastases to lymph nodes 35.99 20.27 25 17274 6999 50580826
Vasogenic cerebral oedema 35.27 20.27 11 17288 476 50587349
Vulval disorder 35.06 20.27 12 17287 698 50587127
Gliosarcoma 34.91 20.27 5 17294 0 50587825
Petechiae 34.70 20.27 31 17268 12481 50575344
Hydrocephalus 34.24 20.27 21 17278 4767 50583058
Sialoadenitis 33.75 20.27 14 17285 1386 50586439
Musculoskeletal stiffness 32.92 20.27 3 17296 128478 50459347
Neutrophil count abnormal 31.99 20.27 16 17283 2443 50585382
Optic neuropathy 31.18 20.27 14 17285 1680 50586145
Peripheral swelling 30.78 20.27 16 17283 205920 50381905
Sinusitis 30.74 20.27 10 17289 170548 50417277
Dehydration 30.68 20.27 118 17181 152331 50435494
Infusion related reaction 30.46 20.27 10 17289 169547 50418278
Lymphocyte count decreased 30.23 20.27 41 17258 26266 50561559
Gastritis fungal 30.02 20.27 7 17292 97 50587728
Lethargy 29.25 20.27 57 17242 49375 50538450
Metastatic malignant melanoma 29.18 20.27 12 17287 1162 50586663
Blood disorder 28.84 20.27 20 17279 5585 50582240
Asthenia 28.77 20.27 197 17102 318845 50268980
Dyspnoea 28.70 20.27 94 17205 547514 50040311
Agranulocytosis 28.68 20.27 36 17263 21385 50566440
Pain 28.56 20.27 102 17197 578801 50009024
DNA mismatch repair protein gene mutation 27.93 20.27 4 17295 0 50587825
Therapy change 27.72 20.27 19 17280 5206 50582619
Maternal exposure during pregnancy 27.70 20.27 10 17289 159768 50428057
Neutrophil count decreased 27.14 20.27 53 17246 45973 50541852
Drug hypersensitivity 26.55 20.27 28 17271 250982 50336843
Needle issue 26.30 20.27 21 17278 7254 50580571
Anxiety 26.24 20.27 14 17285 177592 50410233
Drug clearance decreased 26.05 20.27 11 17288 1138 50586687
Pneumonia fungal 26.02 20.27 17 17282 4303 50583522
Coagulation time prolonged 25.88 20.27 11 17288 1157 50586668
Gastroenteropancreatic neuroendocrine tumour disease 25.79 20.27 5 17294 26 50587799
Swelling 24.07 20.27 20 17279 200852 50386973
Deep vein thrombosis 24.00 20.27 67 17232 73237 50514588
Oesophagitis 23.76 20.27 26 17273 13357 50574468
Wound 23.39 20.27 4 17295 105790 50482035
Therapy cessation 23.26 20.27 36 17263 25975 50561850
Intracranial tumour haemorrhage 23.17 20.27 6 17293 131 50587694
Infrequent bowel movements 22.86 20.27 10 17289 1128 50586697
Liver abscess 22.80 20.27 13 17286 2580 50585245
Carcinoid tumour 22.49 20.27 7 17292 301 50587524
White blood cell count abnormal 22.49 20.27 17 17282 5423 50582402
Abdominal discomfort 22.15 20.27 28 17271 231613 50356212
Ecchymosis 22.08 20.27 22 17277 10147 50577678
Sepsis 22.08 20.27 97 17202 132828 50454997
Brain tumour operation 21.92 20.27 4 17295 14 50587811
Haemoglobin 21.78 20.27 6 17293 167 50587658
Recurrent cancer 21.59 20.27 11 17288 1746 50586079
Mucocutaneous rash 21.49 20.27 4 17295 16 50587809
Radiation interaction 20.95 20.27 3 17296 0 50587825
Cerebral haemorrhage 20.85 20.27 35 17264 27017 50560808
Metastases to lung 20.60 20.27 22 17277 10998 50576827
Asthma 20.60 20.27 3 17296 89334 50498491
Lung infiltration 20.35 20.27 24 17275 13369 50574456

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 565.28 17.87 429 16792 81487 29475819
Tumour pseudoprogression 260.35 17.87 57 17164 319 29556987
Malignant neoplasm progression 241.40 17.87 254 16967 73605 29483701
Product use in unapproved indication 232.49 17.87 269 16952 86606 29470700
Lymphopenia 190.81 17.87 111 17110 13422 29543884
Seizure 188.97 17.87 251 16970 92872 29464434
Thrombocytopenia 176.74 17.87 296 16925 134527 29422779
Neoplasm progression 172.53 17.87 117 17104 18495 29538811
Death 164.86 17.87 503 16718 341581 29215725
Nausea 144.42 17.87 431 16790 288824 29268482
Off label use 103.63 17.87 396 16825 300404 29256902
Vomiting 85.22 17.87 294 16927 211966 29345340
Brain oedema 81.60 17.87 63 17158 12157 29545149
Brain operation 79.28 17.87 21 17200 286 29557020
Hypermutation 77.01 17.87 13 17208 9 29557297
Myelosuppression 75.09 17.87 60 17161 12167 29545139
Radiation necrosis 72.84 17.87 16 17205 91 29557215
Disease recurrence 70.98 17.87 65 17156 15849 29541457
Constipation 67.16 17.87 181 17040 113979 29443327
Glioblastoma 66.42 17.87 24 17197 952 29556354
Hemiparesis 64.27 17.87 59 17162 14427 29542879
Hospice care 62.09 17.87 38 17183 5030 29552276
Diaphragmatic spasm 52.12 17.87 12 17209 87 29557219
Recurrent cancer 51.78 17.87 21 17200 1144 29556162
Pulmonary embolism 50.76 17.87 127 17094 76407 29480899
Aphasia 50.39 17.87 59 17162 19139 29538167
Faecal volume decreased 50.33 17.87 12 17209 103 29557203
Pancreatic neuroendocrine tumour metastatic 47.39 17.87 11 17210 83 29557223
Glioblastoma multiforme 47.39 17.87 17 17204 660 29556646
Lymphocyte count decreased 42.12 17.87 54 17167 19217 29538089
Metastases to liver 40.78 17.87 42 17179 11814 29545492
Deep vein thrombosis 39.89 17.87 97 17124 57302 29500004
Diabetes insipidus 39.76 17.87 22 17199 2412 29554894
Hydrocephalus 39.57 17.87 27 17194 4300 29553006
Hepatic lesion 39.56 17.87 24 17197 3126 29554180
Platelet count decreased 39.24 17.87 142 17079 104530 29452776
Metastases to lung 38.80 17.87 34 17187 7821 29549485
Fatigue 36.37 17.87 311 16910 316510 29240796
Malignant glioma 35.45 17.87 7 17214 21 29557285
Neoplasm recurrence 35.43 17.87 19 17202 1958 29555348
Bone marrow failure 35.41 17.87 60 17161 27389 29529917
Metastases to meninges 34.74 17.87 16 17205 1189 29556117
Magnetic resonance imaging head abnormal 34.56 17.87 16 17205 1203 29556103
Brain neoplasm 34.20 17.87 21 17200 2795 29554511
Haematotoxicity 33.10 17.87 29 17192 6670 29550636
Intussusception 32.20 17.87 12 17209 520 29556786
Myocardial infarction 32.17 17.87 12 17209 110284 29447022
Confusional state 31.83 17.87 153 17068 127724 29429582
Brain neoplasm malignant 31.49 17.87 12 17209 553 29556753
Pancytopenia 31.30 17.87 113 17108 83055 29474251
Swelling of eyelid 30.91 17.87 12 17209 582 29556724
Intracranial tumour haemorrhage 30.49 17.87 10 17211 295 29557011
Aplastic anaemia 30.25 17.87 29 17192 7481 29549825
Gait disturbance 29.61 17.87 102 17119 73247 29484059
Arthralgia 29.36 17.87 23 17198 139594 29417712
Brain tumour operation 29.31 17.87 5 17216 4 29557302
Therapy cessation 29.23 17.87 39 17182 14423 29542883
Skin warm 28.17 17.87 16 17205 1844 29555462
Rosacea 27.88 17.87 13 17208 994 29556312
Metastases to central nervous system 27.72 17.87 27 17194 7104 29550202
Herpes simplex encephalitis 26.51 17.87 9 17212 296 29557010
Hippocampal sclerosis 26.45 17.87 7 17214 95 29557211
Tumour haemorrhage 26.34 17.87 17 17204 2468 29554838
Pneumocystis jirovecii pneumonia 26.18 17.87 40 17181 16739 29540567
Medulloblastoma 25.77 17.87 6 17215 46 29557260
Central nervous system necrosis 25.21 17.87 7 17214 115 29557191
Cardiac failure congestive 24.67 17.87 7 17214 76574 29480732
Cardiac failure 24.19 17.87 8 17213 79279 29478027
Product administered to patient of inappropriate age 22.94 17.87 16 17205 2639 29554667
Hyperglycaemia 22.80 17.87 57 17164 34230 29523076
Blood pressure diastolic increased 22.43 17.87 18 17203 3668 29553638
Porokeratosis 22.43 17.87 6 17215 85 29557221
Nasopharyngitis 22.12 17.87 4 17217 59661 29497645
Oligodendroglioma 21.87 17.87 5 17216 35 29557271
Drug interaction 21.81 17.87 52 17169 197333 29359973
Intracranial pressure increased 21.17 17.87 17 17204 3468 29553838
Paraparesis 21.03 17.87 13 17208 1751 29555555
Anaplastic astrocytoma 20.84 17.87 6 17215 113 29557193
Hospitalisation 20.36 17.87 66 17155 45922 29511384
Alopecia 19.86 17.87 38 17183 19046 29538260
Dyspnoea 19.63 17.87 111 17110 326621 29230685
Paraganglion neoplasm malignant 19.57 17.87 4 17217 15 29557291
Hereditary motor and sensory neuropathy 19.57 17.87 4 17217 15 29557291
Neurological decompensation 19.34 17.87 14 17207 2448 29554858
Unmasking of previously unidentified disease 18.98 17.87 9 17212 714 29556592
Therapy partial responder 18.93 17.87 19 17202 5180 29552126
Rhabdomyolysis 18.78 17.87 6 17215 60802 29496504
Therapy change 18.67 17.87 14 17207 2584 29554722
Epilepsy 18.32 17.87 36 17185 18396 29538910
Craniotomy 18.25 17.87 5 17216 78 29557228
Acute kidney injury 18.24 17.87 86 17135 265181 29292125
Metastatic malignant melanoma 18.22 17.87 12 17209 1803 29555503
Herpes simplex pneumonia 17.89 17.87 4 17217 25 29557281

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 955.38 16.94 668 29127 141012 64327925
Thrombocytopenia 584.07 16.94 612 29183 223189 64245748
Tumour pseudoprogression 475.90 16.94 95 29700 412 64468525
Malignant neoplasm progression 442.77 16.94 387 29408 112484 64356453
Product use in unapproved indication 383.50 16.94 439 29356 176179 64292758
Lymphopenia 319.29 16.94 179 29616 25478 64443459
Death 279.13 16.94 657 29138 482048 63986889
Neoplasm progression 267.68 16.94 190 29605 40774 64428163
Seizure 262.44 16.94 353 29442 166539 64302398
Hypermutation 257.54 16.94 40 29755 11 64468926
Pancytopenia 208.41 16.94 292 29503 143017 64325920
Off label use 207.30 16.94 701 29094 632105 63836832
Bone marrow failure 186.81 16.94 164 29631 47788 64421149
Disease recurrence 169.42 16.94 130 29665 31380 64437557
Platelet count decreased 154.07 16.94 277 29518 167434 64301503
Metastases to liver 144.79 16.94 106 29689 23835 64445102
Myelosuppression 142.97 16.94 105 29690 23725 64445212
Brain oedema 136.36 16.94 99 29696 21976 64446961
Haematotoxicity 123.55 16.94 76 29719 12820 64456117
Hospice care 122.27 16.94 63 29732 7562 64461375
Nausea 117.35 16.94 689 29106 785111 63683826
Hemiparesis 96.56 16.94 92 29703 29735 64439202
Glioblastoma 96.05 16.94 33 29762 1428 64467509
Herpes simplex encephalitis 95.16 16.94 27 29768 614 64468323
Radiation necrosis 92.40 16.94 23 29772 309 64468628
Aplastic anaemia 91.86 16.94 65 29730 13855 64455082
Lymphocyte count decreased 81.06 16.94 97 29698 40602 64428335
Glioblastoma multiforme 79.75 16.94 27 29768 1117 64467820
Leukopenia 77.69 16.94 155 29640 101087 64367850
Febrile neutropenia 76.61 16.94 225 29570 187432 64281505
Magnetic resonance imaging head abnormal 76.57 16.94 32 29763 2380 64466557
Vomiting 75.40 16.94 473 29322 550644 63918293
Arthralgia 74.90 16.94 57 29738 442203 64026734
Malignant glioma 73.90 16.94 14 29781 43 64468894
Hydrocephalus 73.38 16.94 45 29750 7546 64461391
Joint swelling 69.01 16.94 9 29786 215373 64253564
Neutropenia 68.00 16.94 254 29541 239370 64229567
Pulmonary embolism 66.06 16.94 182 29613 146174 64322763
Central nervous system necrosis 65.83 16.94 17 29778 267 64468670
Constipation 63.33 16.94 241 29554 229096 64239841
Metastases to central nervous system 63.18 16.94 52 29743 13860 64455077
Pneumocystis jirovecii pneumonia 58.57 16.94 68 29727 27566 64441371
Brain operation 57.67 16.94 18 29777 573 64468364
Neoplasm recurrence 57.38 16.94 30 29765 3709 64465228
Diaphragmatic spasm 54.65 16.94 12 29783 89 64468848
Intracranial tumour haemorrhage 54.50 16.94 16 29779 412 64468525
Product administered to patient of inappropriate age 54.22 16.94 31 29764 4570 64464367
Metastases to lymph nodes 53.60 16.94 39 29756 8678 64460259
Metastases to peritoneum 53.13 16.94 28 29767 3519 64465418
Recurrent cancer 51.17 16.94 24 29771 2349 64466588
Dyspnoea 50.70 16.94 167 29628 718507 63750430
Hepatic lesion 49.94 16.94 32 29763 5792 64463145
Faecal volume decreased 49.30 16.94 12 29783 146 64468791
Brain neoplasm malignant 49.21 16.94 19 29776 1149 64467788
White blood cell count decreased 48.69 16.94 172 29623 157665 64311272
Therapy cessation 48.29 16.94 67 29728 32422 64436515
Diabetes insipidus 46.78 16.94 28 29767 4493 64464444
Infusion related reaction 45.77 16.94 10 29785 164457 64304480
Agranulocytosis 44.11 16.94 70 29725 38159 64430778
Pancreatic neuroendocrine tumour metastatic 43.15 16.94 10 29785 97 64468840
Brain neoplasm 42.32 16.94 27 29768 4851 64464086
Metastases to lung 41.82 16.94 43 29752 15221 64453716
Petechiae 41.43 16.94 47 29748 18579 64450358
Brain tumour operation 41.43 16.94 8 29787 28 64468909
Arthropathy 41.38 16.94 4 29791 120963 64347974
Therapy change 40.05 16.94 29 29766 6405 64462532
Contraindicated product administered 38.42 16.94 3 29792 107826 64361111
Deep vein thrombosis 38.08 16.94 121 29674 105061 64363876
Aphasia 38.01 16.94 68 29727 40838 64428099
Needle issue 36.65 16.94 32 29763 9240 64459697
Angina bullosa haemorrhagica 36.64 16.94 10 29785 196 64468741
Therapeutic product effect decreased 36.49 16.94 5 29790 115346 64353591
Metastases to meninges 35.97 16.94 20 29775 2795 64466142
Musculoskeletal stiffness 35.29 16.94 7 29788 123199 64345738
Metastatic malignant melanoma 35.08 16.94 19 29776 2522 64466415
Jaw operation 34.32 16.94 13 29782 746 64468191
Cardiac failure congestive 34.24 16.94 9 29786 130571 64338366
Gliosarcoma 33.40 16.94 5 29790 0 64468937
Myocardial infarction 32.59 16.94 18 29777 165803 64303134
Mental status changes 31.56 16.94 80 29715 61082 64407855
Fatigue 31.30 16.94 502 29293 748228 63720709
Crystal nephropathy 31.06 16.94 14 29781 1251 64467686
Product dispensing error 30.90 16.94 32 29763 11418 64457519
Sialoadenitis 30.61 16.94 15 29780 1618 64467319
Asthma 30.43 16.94 4 29791 95221 64373716
Ganglioneuroma 30.01 16.94 8 29787 143 64468794
Pain 29.81 16.94 143 29652 553368 63915569
Anxiety 29.54 16.94 30 29765 202619 64266318
Tumour haemorrhage 29.47 16.94 19 29776 3474 64465463
Blood pressure diastolic increased 28.93 16.94 30 29765 10722 64458215
Facial asymmetry 28.14 16.94 11 29784 688 64468249
Neutrophil count decreased 28.11 16.94 89 29706 77107 64391830
Vulval disorder 27.93 16.94 10 29785 489 64468448
Hospitalisation 27.65 16.94 87 29708 75120 64393817
Metastasis 27.36 16.94 22 29773 5673 64463264
Glioma 27.16 16.94 10 29785 530 64468407
DNA mismatch repair protein gene mutation 26.72 16.94 4 29791 0 64468937
Hippocampal sclerosis 25.71 16.94 7 29788 136 64468801
Anaplastic astrocytoma 25.33 16.94 7 29788 144 64468793
Alanine aminotransferase increased 25.26 16.94 129 29666 138902 64330035
Body temperature decreased 25.25 16.94 44 29751 25884 64443053
Asthenia 25.11 16.94 305 29490 427739 64041198
Cardiac failure 25.11 16.94 15 29780 132358 64336579
Myalgia 24.85 16.94 22 29773 158595 64310342
Oligodendroglioma 24.80 16.94 6 29789 71 64468866
Hyperglycaemia 24.72 16.94 73 29722 60895 64408042
Rhabdomyolysis 24.67 16.94 6 29789 91720 64377217
Vasogenic cerebral oedema 24.52 16.94 11 29784 972 64467965
Cerebral haemorrhage 24.48 16.94 65 29730 51025 64417912
Sinusitis 24.39 16.94 19 29776 145909 64323028
Metastases to bone 24.37 16.94 38 29757 20397 64448540
Febrile bone marrow aplasia 24.35 16.94 28 29767 11227 64457710
Muscle swelling 24.24 16.94 10 29785 720 64468217
Tumour necrosis 24.21 16.94 13 29782 1696 64467241
Radiation injury 24.18 16.94 10 29785 724 64468213
Dehydration 24.06 16.94 177 29618 216586 64252351
Gastroenteropancreatic neuroendocrine tumour disease 23.83 16.94 5 29790 29 64468908
Toxicity to various agents 23.82 16.94 87 29708 363426 64105511
Arthritis 23.50 16.94 5 29790 83809 64385128
Nasopharyngitis 23.32 16.94 34 29761 196039 64272898
Incoherent 23.11 16.94 22 29773 7096 64461841
Astrocytoma 23.08 16.94 7 29788 202 64468735
Therapy partial responder 23.03 16.94 26 29769 10222 64458715
Pain in extremity 22.99 16.94 68 29727 303017 64165920
Epilepsy 22.94 16.94 49 29746 33482 64435455
Hyperkalaemia 22.92 16.94 9 29786 101120 64367817
Hyperhidrosis 22.53 16.94 15 29780 124905 64344032
Optic neuropathy 22.07 16.94 15 29780 2996 64465941
Condition aggravated 21.94 16.94 93 29702 372333 64096604
Electrocardiogram QT prolonged 21.75 16.94 5 29790 79443 64389494
Abdominal discomfort 21.30 16.94 32 29763 182290 64286647
Swelling of eyelid 21.20 16.94 13 29782 2179 64466758
Maternal exposure during pregnancy 20.97 16.94 9 29786 95875 64373062
Ataxia 20.88 16.94 37 29758 22047 64446890
Wound 20.57 16.94 5 29790 76472 64392465
Radiation interaction 20.53 16.94 5 29790 61 64468876
Bone marrow disorder 20.53 16.94 14 29781 2811 64466126
Monocyte count decreased 20.39 16.94 14 29781 2843 64466094
Encephalomalacia 20.38 16.94 10 29785 1081 64467856
Malaise 20.36 16.94 104 29691 396143 64072794
Acute kidney injury 20.31 16.94 123 29672 449117 64019820
Wheezing 20.29 16.94 6 29789 80573 64388364
Oligoastrocytoma 20.04 16.94 3 29792 0 64468937
Early satiety 19.98 16.94 10 29785 1129 64467808
Acute myocardial infarction 19.88 16.94 4 29791 69714 64399223
Acquired gene mutation 19.77 16.94 12 29783 1974 64466963
Intracranial pressure increased 19.71 16.94 20 29775 6969 64461968
Depression 19.69 16.94 34 29761 183257 64285680
Craniotomy 19.68 16.94 7 29788 336 64468601
Breast necrosis 19.58 16.94 5 29790 75 64468862
Gastritis fungal 19.35 16.94 6 29789 187 64468750
Dizziness 19.32 16.94 118 29677 430045 64038892
Psoriasis 18.68 16.94 5 29790 71698 64397239
Acute myeloid leukaemia 18.63 16.94 40 29755 27423 64441514
Suicidal ideation 18.59 16.94 4 29791 66538 64402399
Meningitis 18.49 16.94 21 29774 8308 64460629
Suicide attempt 18.41 16.94 5 29790 71002 64397935
Drug-induced liver injury 18.33 16.94 56 29739 47587 64421350
Mucocutaneous rash 18.30 16.94 4 29791 29 64468908
Coronary artery disease 18.24 16.94 3 29792 60430 64408507
Blood disorder 18.21 16.94 19 29776 6838 64462099
Infrequent bowel movements 18.20 16.94 10 29785 1365 64467572
Hypersensitivity 18.02 16.94 40 29755 196412 64272525
Porokeratosis 17.96 16.94 6 29789 238 64468699
Meningitis bacterial 17.95 16.94 12 29783 2331 64466606
Skin striae 17.83 16.94 10 29785 1420 64467517
Neoplasm 17.81 16.94 19 29776 7012 64461925
Tongue ulceration 17.40 16.94 14 29781 3612 64465325
Weight decreased 17.34 16.94 205 29590 285534 64183403
Skin warm 17.30 16.94 17 29778 5700 64463237
Fat necrosis 17.21 16.94 8 29787 767 64468170
Strongyloidiasis 17.15 16.94 13 29782 3077 64465860
Bronchitis 17.13 16.94 15 29780 108728 64360209

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC L01AX03 ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
ANTINEOPLASTIC AGENTS
ALKYLATING AGENTS
Other alkylating agents
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
MeSH PA D009676 Noxae
CHEBI has role CHEBI:35610 antineoplastic agents
CHEBI has role CHEBI:50266 Prodrugs

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Astrocytoma, anaplastic indication 55353007 DOID:3078
Ewing's sarcoma indication 76909002 DOID:3369
Glioblastoma multiforme of brain indication 276828006 DOID:3073
Metastatic malignant melanoma off-label use 443493003
Pancreatic Neuroendocrine Tumor off-label use 717919005
Lymphocytopenia contraindication 48813009 DOID:614
Acute nephropathy contraindication 58574008
Hepatic failure contraindication 59927004
Myelodysplastic syndrome contraindication 109995007
Pancytopenia contraindication 127034005 DOID:12450
Anemia contraindication 271737000 DOID:2355
Pregnancy, function contraindication 289908002
Thrombocytopenic disorder contraindication 302215000 DOID:1588
Neutropenic disorder contraindication 303011007 DOID:1227
Aplastic anemia contraindication 306058006 DOID:12449
Bone marrow depression contraindication 307762000
Breastfeeding (mother) contraindication 413712001
Pneumocystosis jiroveci pneumonia contraindication 415125002 DOID:11339




๐Ÿถ Veterinary Drug Use

None

๐Ÿถ Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 12.94 acidic
pKa2 1.16 Basic
pKa3 0.53 Basic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

None

External reference:

IDSource
4021173 VUID
N0000148622 NUI
D06067 KEGG_DRUG
4021173 VANDF
C0076080 UMLSCUI
CHEBI:72564 CHEBI
CHEMBL810 ChEMBL_ID
DB00853 DRUGBANK_ID
D000077204 MESH_DESCRIPTOR_UI
5394 PUBCHEM_CID
6027 INN_ID
7301 IUPHAR_LIGAND_ID
YF1K15M17Y UNII
37776 RXNORM
172754 MMSL
8290 MMSL
d04451 MMSL
007794 NDDF
116099008 SNOMEDCT_US
387009002 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
TEMODAR HUMAN PRESCRIPTION DRUG LABEL 1 0085-1366 CAPSULE 100 mg ORAL NDA 33 sections
TEMODAR HUMAN PRESCRIPTION DRUG LABEL 1 0085-1381 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 2.50 mg INTRAVENOUS NDA 33 sections
TEMODAR HUMAN PRESCRIPTION DRUG LABEL 1 0085-1417 CAPSULE 250 mg ORAL NDA 33 sections
TEMODAR HUMAN PRESCRIPTION DRUG LABEL 1 0085-1425 CAPSULE 140 mg ORAL NDA 33 sections
TEMODAR HUMAN PRESCRIPTION DRUG LABEL 1 0085-1430 CAPSULE 180 mg ORAL NDA 33 sections
TEMODAR HUMAN PRESCRIPTION DRUG LABEL 1 0085-1519 CAPSULE 20 mg ORAL NDA 33 sections
TEMODAR HUMAN PRESCRIPTION DRUG LABEL 1 0085-3004 CAPSULE 5 mg ORAL NDA 33 sections
Temozolomide HUMAN PRESCRIPTION DRUG LABEL 1 0527-1777 CAPSULE 5 mg ORAL ANDA 28 sections
Temozolomide HUMAN PRESCRIPTION DRUG LABEL 1 0527-1778 CAPSULE 20 mg ORAL ANDA 28 sections
Temozolomide HUMAN PRESCRIPTION DRUG LABEL 1 0527-1779 CAPSULE 100 mg ORAL ANDA 28 sections
Temozolomide HUMAN PRESCRIPTION DRUG LABEL 1 0527-1780 CAPSULE 140 mg ORAL ANDA 28 sections
Temozolomide HUMAN PRESCRIPTION DRUG LABEL 1 0527-1781 CAPSULE 180 mg ORAL ANDA 28 sections
Temozolomide HUMAN PRESCRIPTION DRUG LABEL 1 0527-1782 CAPSULE 250 mg ORAL ANDA 28 sections
Temozolomide HUMAN PRESCRIPTION DRUG LABEL 1 0781-2691 CAPSULE 5 mg ORAL NDA AUTHORIZED GENERIC 31 sections
Temozolomide HUMAN PRESCRIPTION DRUG LABEL 1 0781-2692 CAPSULE 20 mg ORAL NDA AUTHORIZED GENERIC 31 sections
Temozolomide HUMAN PRESCRIPTION DRUG LABEL 1 0781-2693 CAPSULE 100 mg ORAL NDA AUTHORIZED GENERIC 31 sections
Temozolomide HUMAN PRESCRIPTION DRUG LABEL 1 0781-2694 CAPSULE 140 mg ORAL NDA AUTHORIZED GENERIC 31 sections
Temozolomide HUMAN PRESCRIPTION DRUG LABEL 1 0781-2695 CAPSULE 180 mg ORAL NDA AUTHORIZED GENERIC 31 sections
Temozolomide HUMAN PRESCRIPTION DRUG LABEL 1 0781-2696 CAPSULE 250 mg ORAL NDA AUTHORIZED GENERIC 31 sections
Temozolomide HUMAN PRESCRIPTION DRUG LABEL 1 16729-048 CAPSULE 5 mg ORAL ANDA 29 sections
Temozolomide HUMAN PRESCRIPTION DRUG LABEL 1 16729-049 CAPSULE 20 mg ORAL ANDA 29 sections
Temozolomide HUMAN PRESCRIPTION DRUG LABEL 1 16729-050 CAPSULE 100 mg ORAL ANDA 29 sections
Temozolomide HUMAN PRESCRIPTION DRUG LABEL 1 16729-051 CAPSULE 250 mg ORAL ANDA 29 sections
Temozolomide HUMAN PRESCRIPTION DRUG LABEL 1 16729-129 CAPSULE 140 mg ORAL ANDA 29 sections
Temozolomide HUMAN PRESCRIPTION DRUG LABEL 1 16729-130 CAPSULE 180 mg ORAL ANDA 29 sections
Temozolomide HUMAN PRESCRIPTION DRUG LABEL 1 23155-774 CAPSULE 5 mg ORAL ANDA 16 sections
Temozolomide HUMAN PRESCRIPTION DRUG LABEL 1 23155-775 CAPSULE 20 mg ORAL ANDA 16 sections
Temozolomide HUMAN PRESCRIPTION DRUG LABEL 1 23155-776 CAPSULE 100 mg ORAL ANDA 16 sections
Temozolomide HUMAN PRESCRIPTION DRUG LABEL 1 23155-777 CAPSULE 140 mg ORAL ANDA 16 sections
Temozolomide HUMAN PRESCRIPTION DRUG LABEL 1 23155-778 CAPSULE 180 mg ORAL ANDA 16 sections