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) 1 Bocci G, Oprea TI, Benet LZ
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
S (Water solubility) 3 mg/mL Bocci G, Oprea TI, Benet LZ

Approvals:

DateAgencyCompanyOrphan
July 26, 2007 PMDA Schering-Plough K.K.
Aug. 11, 1999 FDA MERCK SHARP DOHME
Jan. 26, 1999 EMA MERCK SHARP & DOHME B.V.

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 751.20 21.44 504 18935 150653 63318930
Disease progression 704.18 21.44 448 18991 122310 63347273
Malignant neoplasm progression 446.09 21.44 290 19149 81831 63387752
Pancytopenia 348.48 21.44 266 19173 96667 63372916
Tumour pseudoprogression 330.72 21.44 60 19379 232 63469351
Product use in unapproved indication 287.04 21.44 312 19127 178768 63290815
Bone marrow failure 218.94 21.44 127 19312 29163 63440420
Hypermutation 210.46 21.44 31 19408 11 63469572
Death 202.90 21.44 389 19050 373992 63095591
Seizure 201.71 21.44 225 19214 132409 63337174
Neutropenia 199.01 21.44 256 19183 174749 63294834
Platelet count decreased 190.45 21.44 205 19234 115917 63353666
Myelosuppression 177.72 21.44 103 19336 23600 63445983
Neoplasm progression 176.55 21.44 120 19319 36308 63433275
Lymphopenia 157.26 21.44 87 19352 18240 63451343
Off label use 154.51 21.44 504 18935 673958 62795625
Metastases to liver 149.33 21.44 92 19347 23547 63446036
Haematotoxicity 147.04 21.44 67 19372 9309 63460274
Febrile neutropenia 124.73 21.44 167 19272 118282 63351301
Vasogenic cerebral oedema 120.59 21.44 32 19407 864 63468719
Aplastic anaemia 106.36 21.44 54 19385 9515 63460068
Eastern Cooperative Oncology Group performance status worsened 105.54 21.44 31 19408 1223 63468360
Leukopenia 100.36 21.44 121 19318 77169 63392414
Brain oedema 96.71 21.44 58 19381 14137 63455446
Hospice care 94.73 21.44 47 19392 7885 63461698
Disease recurrence 91.97 21.44 73 19366 27957 63441626
Joint swelling 77.65 21.44 6 19433 327660 63141923
Glioblastoma multiforme 77.13 21.44 22 19417 781 63468802
Herpes simplex encephalitis 73.89 21.44 18 19421 341 63469242
Radiation necrosis 71.78 21.44 18 19421 386 63469197
Hemiparesis 68.69 21.44 57 19382 23225 63446358
Metastases to peritoneum 68.20 21.44 29 19410 3413 63466170
Therapy partial responder 63.54 21.44 40 19399 10618 63458965
Eastern Cooperative Oncology Group performance status improved 57.59 21.44 9 19430 9 63469574
Pulmonary embolism 55.33 21.44 115 19324 116569 63353014
Angina bullosa haemorrhagica 55.33 21.44 12 19427 132 63469451
Metastases to lymph nodes 54.70 21.44 33 19406 8125 63461458
Ascites 53.21 21.44 64 19375 40664 63428919
Brain neoplasm 52.52 21.44 26 19413 4340 63465243
Arthralgia 51.82 21.44 59 19380 569651 62899932
Neoplasm recurrence 51.52 21.44 22 19417 2616 63466967
Malignant glioma 50.71 21.44 8 19431 9 63469574
Glioblastoma 50.41 21.44 16 19423 821 63468762
Central nervous system necrosis 49.24 21.44 11 19428 140 63469443
Metastases to central nervous system 47.03 21.44 36 19403 13069 63456514
Nausea 46.53 21.44 431 19008 854040 62615543
Neurological symptom 45.64 21.44 26 19413 5757 63463826
Infusion related reaction 45.11 21.44 10 19429 245511 63224072
Brain neoplasm malignant 45.07 21.44 16 19423 1160 63468423
Pneumocystis jirovecii pneumonia 44.95 21.44 39 19400 16875 63452708
Diffuse large B-cell lymphoma recurrent 44.16 21.44 19 19420 2301 63467282
White blood cell count decreased 43.97 21.44 117 19322 138987 63330596
Mental status changes 43.40 21.44 57 19382 39542 63430041
Magnetic resonance imaging head abnormal 43.36 21.44 18 19421 1995 63467588
Muscle swelling 40.83 21.44 12 19427 474 63469109
Crystal nephropathy 40.73 21.44 14 19425 922 63468661
Sinusitis 40.12 21.44 10 19429 226643 63242940
Pain 39.77 21.44 107 19332 740521 62729062
Musculoskeletal stiffness 39.47 21.44 5 19434 184613 63284970
Ganglioneuroma 39.04 21.44 9 19430 133 63469450
Facial asymmetry 38.80 21.44 13 19426 792 63468791
Platelet transfusion 38.79 21.44 13 19426 793 63468790
Maternal exposure during pregnancy 38.39 21.44 10 19429 220052 63249531
Vomiting 38.12 21.44 297 19142 559320 62910263
Jaw operation 38.08 21.44 13 19426 839 63468744
Hydrocephalus 36.99 21.44 22 19417 5278 63464305
Petechiae 36.84 21.44 32 19407 13865 63455718
Early satiety 36.09 21.44 13 19426 983 63468600
Wound 35.94 21.44 4 19435 163259 63306324
Gliosarcoma 35.46 21.44 5 19434 0 63469583
Enterocutaneous fistula 35.27 21.44 14 19425 1383 63468200
Abdominal discomfort 35.23 21.44 28 19411 320857 63148726
Swelling 34.23 21.44 21 19418 275357 63194226
Vulval disorder 33.94 21.44 12 19427 860 63468723
Dehydration 33.58 21.44 123 19316 173231 63296352
Peripheral swelling 33.44 21.44 20 19419 265922 63203661
Sialoadenitis 32.84 21.44 14 19425 1658 63467925
Neutrophil count abnormal 31.20 21.44 16 19423 2876 63466707
Asthenia 30.88 21.44 212 19227 383392 63086191
Lymphocyte count decreased 30.78 21.44 42 19397 30215 63439368
Drug hypersensitivity 30.62 21.44 30 19409 310657 63158926
Recurrent cancer 30.52 21.44 14 19425 1973 63467610
Gastritis fungal 30.27 21.44 7 19432 105 63469478
Optic neuropathy 30.22 21.44 14 19425 2018 63467565
Lethargy 29.87 21.44 58 19381 55949 63413634
Metastatic malignant melanoma 29.14 21.44 12 19427 1303 63468280
Agranulocytosis 28.82 21.44 37 19402 25097 63444486
Asthma 28.39 21.44 3 19436 127558 63342025
DNA mismatch repair protein gene mutation 28.37 21.44 4 19435 0 63469583
Therapy cessation 27.60 21.44 40 19399 30417 63439166
Blood disorder 27.42 21.44 20 19419 6751 63462832
Therapy change 27.00 21.44 19 19420 6062 63463521
Dyspnoea 26.83 21.44 108 19331 661205 62808378
Sepsis 26.63 21.44 105 19334 153018 63316565
Anxiety 26.46 21.44 17 19422 217524 63252059
Deep vein thrombosis 25.96 21.44 70 19369 83730 63385853
Gastroenteropancreatic neuroendocrine tumour disease 25.74 21.44 5 19434 30 63469553
Neutrophil count decreased 24.87 21.44 54 19385 56352 63413231
Drug intolerance 24.83 21.44 35 19404 308626 63160957
Coagulation time prolonged 24.77 21.44 11 19428 1437 63468146
Drug clearance decreased 24.51 21.44 11 19428 1473 63468110
Metastases to bone marrow 24.43 21.44 8 19431 454 63469129
Pneumonia fungal 24.12 21.44 17 19422 5438 63464145
Needle issue 23.76 21.44 22 19417 10354 63459229
Oesophagitis 23.67 21.44 26 19413 14982 63454601
Condition aggravated 23.14 21.44 56 19383 402161 63067422
Liver abscess 22.98 21.44 13 19426 2841 63466742
Infrequent bowel movements 22.62 21.44 10 19429 1292 63468291
Ecchymosis 22.51 21.44 22 19417 11072 63458511
Acute hepatitis B 22.38 21.44 7 19432 342 63469241
White blood cell count abnormal 22.07 21.44 17 19422 6225 63463358
Haemoglobin 22.07 21.44 6 19433 178 63469405
Mucocutaneous rash 21.93 21.44 4 19435 16 63469567
Hypersensitivity 21.79 21.44 35 19404 292650 63176933
Carcinoid tumour 21.60 21.44 7 19432 384 63469199

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 829.47 17.99 591 18772 107486 34830082
Product use in unapproved indication 356.40 17.99 379 18984 117120 34820448
Tumour pseudoprogression 290.17 17.99 65 19298 435 34937133
Malignant neoplasm progression 279.08 17.99 291 19072 87755 34849813
Thrombocytopenia 245.98 17.99 363 19000 155884 34781684
Seizure 219.79 17.99 280 19083 104577 34832991
Death 194.12 17.99 569 18794 397480 34540088
Lymphopenia 191.83 17.99 117 19246 16218 34921350
Neoplasm progression 181.23 17.99 129 19234 23171 34914397
Nausea 155.94 17.99 476 18887 339432 34598136
Hypermutation 107.21 17.99 18 19345 13 34937555
Disease recurrence 96.11 17.99 86 19277 21404 34916164
Vomiting 96.08 17.99 328 19035 247293 34690275
Myelosuppression 87.94 17.99 78 19285 19187 34918381
Off label use 87.16 17.99 459 18904 419065 34518503
Glioblastoma 84.73 17.99 29 19334 1030 34936538
Brain oedema 81.77 17.99 65 19298 13756 34923812
Radiation necrosis 80.39 17.99 18 19345 120 34937448
Hospice care 79.62 17.99 49 19314 6891 34930677
Brain operation 78.20 17.99 21 19342 319 34937249
Hemiparesis 74.25 17.99 65 19298 15713 34921855
Constipation 68.18 17.99 198 19165 136784 34800784
Eastern Cooperative Oncology Group performance status worsened 66.83 17.99 24 19339 984 34936584
Aphasia 57.41 17.99 65 19298 21389 34916179
Product use issue 56.93 17.99 115 19248 63101 34874467
Hydrocephalus 55.12 17.99 35 19328 5197 34932371
Recurrent cancer 52.58 17.99 22 19341 1365 34936203
Metastases to liver 52.02 17.99 50 19313 13613 34923955
Neoplasm recurrence 51.24 17.99 25 19338 2224 34935344
Diaphragmatic spasm 50.83 17.99 12 19351 104 34937464
Glioblastoma multiforme 50.55 17.99 18 19345 720 34936848
Faecal volume decreased 49.47 17.99 12 19351 118 34937450
Haematotoxicity 49.46 17.99 39 19324 8155 34929413
Fatigue 49.25 17.99 362 19001 370291 34567277
Pulmonary embolism 47.78 17.99 133 19230 89613 34847955
Metastases to lung 47.09 17.99 40 19323 9280 34928288
Pancreatic neuroendocrine tumour metastatic 47.05 17.99 11 19352 91 34937477
Metastases to meninges 41.87 17.99 19 19344 1435 34936133
Malignant glioma 41.43 17.99 8 19355 22 34937546
Platelet count decreased 41.43 17.99 153 19210 119564 34818004
Therapy cessation 39.70 17.99 48 19315 16925 34920643
Diabetes insipidus 39.63 17.99 23 19340 2905 34934663
Hepatic lesion 39.52 17.99 25 19338 3687 34933881
Deep vein thrombosis 39.05 17.99 101 19262 65147 34872421
Bone marrow failure 38.81 17.99 63 19300 29190 34908378
Arthralgia 37.50 17.99 24 19339 170017 34767551
Lymphocyte count decreased 37.46 17.99 54 19309 22568 34915000
Drug ineffective 36.80 17.99 400 18963 456351 34481217
Brain neoplasm 35.14 17.99 22 19341 3187 34934381
Therapy partial responder 34.37 17.99 34 19329 9582 34927986
Intussusception 34.07 17.99 13 19350 633 34936935
Magnetic resonance imaging head abnormal 33.64 17.99 16 19347 1345 34936223
Myocardial infarction 32.82 17.99 13 19350 121072 34816496
Confusional state 32.63 17.99 162 19201 143998 34793570
Intracranial tumour haemorrhage 30.06 17.99 10 19353 325 34937243
Brain tumour operation 29.56 17.99 5 19358 4 34937564
Metastases to central nervous system 29.31 17.99 29 19334 8176 34929392
Tumour haemorrhage 29.19 17.99 19 19344 2943 34934625
Cardiac failure 27.84 17.99 8 19355 91240 34846328
Drug interaction 27.62 17.99 52 19311 225894 34711674
Pancytopenia 27.53 17.99 115 19248 95042 34842526
Brain neoplasm malignant 27.28 17.99 12 19351 842 34936726
Neutropenia 27.27 17.99 164 19199 156614 34780954
Bone marrow disorder 27.18 17.99 15 19348 1720 34935848
Pneumocystis jirovecii pneumonia 26.89 17.99 43 19320 19667 34917901
Rosacea 26.40 17.99 13 19350 1180 34936388
Skin warm 26.24 17.99 16 19347 2211 34935357
Hippocampal sclerosis 26.02 17.99 7 19356 107 34937461
Herpes simplex encephalitis 25.99 17.99 9 19354 331 34937237
Generalised tonic-clonic seizure 25.93 17.99 44 19319 21130 34916438
Radiation injury 25.62 17.99 10 19353 518 34937050
Metastasis 25.60 17.99 20 19343 4124 34933444
Dyspnoea 25.39 17.99 115 19248 376667 34560901
Central nervous system necrosis 25.33 17.99 7 19356 119 34937449
Aplastic anaemia 25.24 17.99 29 19334 9687 34927881
COVID-19 25.18 17.99 6 19357 77544 34860024
Swelling of eyelid 24.26 17.99 12 19351 1099 34936469
Cardiac failure congestive 24.15 17.99 8 19355 83262 34854306
Medulloblastoma 24.12 17.99 6 19357 66 34937502
Gait disturbance 23.92 17.99 102 19261 85038 34852530
Nasopharyngitis 23.55 17.99 5 19358 69963 34867605
Product administered to patient of inappropriate age 22.79 17.99 17 19346 3274 34934294
Blood pressure diastolic increased 22.23 17.99 20 19343 5005 34932563
Acquired gene mutation 22.02 17.99 12 19351 1343 34936225
Oligodendroglioma 22.00 17.99 5 19358 36 34937532
Porokeratosis 21.88 17.99 6 19357 99 34937469
Therapy interrupted 21.66 17.99 32 19331 13665 34923903
Epilepsy 21.63 17.99 41 19322 21454 34916114
Ataxia 21.38 17.99 32 19331 13821 34923747
Atrial fibrillation 21.09 17.99 22 19341 122371 34815197
Anaplastic astrocytoma 21.08 17.99 6 19357 114 34937454
Paraparesis 20.81 17.99 13 19350 1876 34935692
Rhabdomyolysis 20.75 17.99 6 19357 68157 34869411
Hospitalisation 20.72 17.99 74 19289 56828 34880740
Intracranial pressure increased 20.03 17.99 17 19346 3938 34933630
Hereditary motor and sensory neuropathy 19.77 17.99 4 19359 15 34937553
Hyperglycaemia 19.51 17.99 57 19306 39423 34898145
Craniotomy 19.49 17.99 6 19357 151 34937417
Paraganglion neoplasm malignant 19.19 17.99 4 19359 18 34937550
Product dose omission issue 19.01 17.99 23 19340 119688 34817880
Joint swelling 18.73 17.99 5 19358 59885 34877683
Drug reaction with eosinophilia and systemic symptoms 18.61 17.99 50 19313 32962 34904606
Astrocytoma 18.34 17.99 6 19357 185 34937383
Herpes simplex pneumonia 18.09 17.99 4 19359 25 34937543

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 1394.70 17.18 900 32618 183462 79527408
Thrombocytopenia 841.86 17.18 773 32745 264486 79446384
Product use in unapproved indication 567.48 17.18 608 32910 249751 79461119
Malignant neoplasm progression 565.18 17.18 463 33055 135527 79575343
Tumour pseudoprogression 509.87 17.18 104 33414 575 79710295
Death 344.45 17.18 743 32775 565771 79145099
Lymphopenia 335.21 17.18 190 33328 30367 79680503
Neoplasm progression 328.03 17.18 227 33291 51455 79659415
Seizure 321.36 17.18 396 33122 188438 79522432
Hypermutation 296.49 17.18 46 33472 18 79710852
Pancytopenia 220.33 17.18 308 33210 165437 79545433
Disease recurrence 208.01 17.18 162 33356 43947 79666923
Bone marrow failure 199.34 17.18 168 33350 50939 79659931
Myelosuppression 196.56 17.18 151 33367 40145 79670725
Off label use 185.12 17.18 811 32707 906404 78804466
Metastases to liver 176.36 17.18 123 33395 28191 79682679
Eastern Cooperative Oncology Group performance status worsened 174.10 17.18 55 33463 2010 79708860
Haematotoxicity 168.79 17.18 96 33422 15423 79695447
Platelet count decreased 164.54 17.18 294 33224 194370 79516500
Neutropenia 164.51 17.18 369 33149 287341 79423529
Brain oedema 141.78 17.18 103 33415 25160 79685710
Hospice care 140.30 17.18 74 33444 10250 79700620
Therapy partial responder 133.38 17.18 86 33432 17311 79693559
Nausea 123.17 17.18 753 32765 956443 78754427
Glioblastoma 118.64 17.18 39 33479 1621 79709249
Radiation necrosis 112.44 17.18 28 33490 417 79710453
Hemiparesis 105.74 17.18 98 33420 33635 79677235
Vasogenic cerebral oedema 94.46 17.18 32 33486 1461 79709409
Herpes simplex encephalitis 93.99 17.18 27 33491 709 79710161
Aplastic anaemia 93.70 17.18 70 33448 17835 79693035
Arthralgia 92.12 17.18 64 33454 571739 79139131
Hydrocephalus 91.28 17.18 53 33465 8847 79702023
Joint swelling 89.10 17.18 9 33509 288637 79422233
Glioblastoma multiforme 88.36 17.18 29 33489 1199 79709671
Vomiting 84.15 17.18 522 32996 665306 79045564
Malignant glioma 79.43 17.18 15 33503 51 79710819
Leukopenia 78.58 17.18 160 33358 116353 79594517
Lymphocyte count decreased 78.32 17.18 98 33420 47191 79663679
Febrile neutropenia 78.26 17.18 244 33274 230755 79480115
Metastases to peritoneum 75.95 17.18 37 33481 4335 79706535
Magnetic resonance imaging head abnormal 75.71 17.18 32 33486 2694 79708176
Metastases to lymph nodes 71.43 17.18 48 33470 10349 79700521
Neoplasm recurrence 71.22 17.18 35 33483 4179 79706691
Pulmonary embolism 68.29 17.18 192 33326 171462 79539408
Pneumocystis jirovecii pneumonia 68.14 17.18 76 33442 32432 79678438
Central nervous system necrosis 66.90 17.18 17 33501 276 79710594
Constipation 64.91 17.18 263 33255 282787 79428083
Infusion related reaction 64.19 17.18 10 33508 230227 79480643
Metastases to central nervous system 64.15 17.18 54 33464 16321 79694549
Brain operation 61.45 17.18 19 33499 646 79710224
Arthropathy 58.82 17.18 4 33514 177107 79533763
Product administered to patient of inappropriate age 56.76 17.18 33 33485 5520 79705350
Eastern Cooperative Oncology Group performance status improved 54.74 17.18 9 33509 9 79710861
Contraindicated product administered 53.99 17.18 3 33515 157535 79553335
Brain neoplasm 53.64 17.18 32 33486 5614 79705256
Recurrent cancer 53.52 17.18 25 33493 2668 79708202
Diaphragmatic spasm 53.42 17.18 12 33506 111 79710759
Therapy cessation 53.09 17.18 72 33446 37490 79673380
Dyspnoea 53.08 17.18 184 33334 856841 78854029
Intracranial tumour haemorrhage 52.47 17.18 16 33502 519 79710351
Metastases to lung 51.63 17.18 50 33468 18113 79692757
Therapeutic product effect decreased 50.82 17.18 5 33513 163858 79547012
Hepatic lesion 49.91 17.18 33 33485 6926 79703944
Diabetes insipidus 47.98 17.18 29 33489 5208 79705662
Faecal volume decreased 47.86 17.18 12 33506 184 79710686
Brain neoplasm malignant 47.21 17.18 20 33498 1693 79709177
Musculoskeletal stiffness 45.71 17.18 9 33509 174999 79535871
White blood cell count decreased 45.57 17.18 178 33340 188110 79522760
Pain 44.96 17.18 149 33369 703653 79007217
Metastases to meninges 43.85 17.18 24 33494 3577 79707293
Aphasia 43.84 17.18 74 33444 46658 79664212
Petechiae 42.96 17.18 48 33470 20517 79690353
Asthma 42.21 17.18 4 33514 135091 79575779
Pancreatic neuroendocrine tumour metastatic 42.08 17.18 10 33508 121 79710749
Agranulocytosis 41.84 17.18 71 33447 44959 79665911
Metastasis 40.76 17.18 29 33489 6851 79704019
Mental status changes 39.38 17.18 87 33431 66872 79643998
Deep vein thrombosis 39.31 17.18 126 33392 120793 79590077
Drug ineffective 39.18 17.18 654 32864 1080259 78630611
Therapy change 38.87 17.18 29 33489 7370 79703500
Neurological symptom 38.67 17.18 31 33487 8752 79702118
Platelet transfusion 38.23 17.18 19 33499 2323 79708547
Angina bullosa haemorrhagica 36.88 17.18 10 33508 211 79710659
Acquired gene mutation 36.11 17.18 18 33500 2215 79708655
Brain tumour operation 35.91 17.18 8 33510 71 79710799
Fatigue 35.67 17.18 568 32950 929159 78781711
Tumour haemorrhage 35.54 17.18 22 33496 4122 79706748
Sinusitis 35.41 17.18 19 33499 195482 79515388
Abdominal discomfort 35.33 17.18 32 33486 250695 79460175
Metastatic malignant melanoma 34.64 17.18 19 33499 2844 79708026
Jaw operation 34.40 17.18 13 33505 816 79710054
Radiation injury 34.19 17.18 13 33505 830 79710040
Gliosarcoma 33.88 17.18 5 33513 0 79710870
Nasopharyngitis 32.77 17.18 35 33483 253846 79457024
Condition aggravated 32.70 17.18 105 33413 501019 79209851
Wound 32.47 17.18 5 33513 116174 79594696
Peritumoural oedema 32.34 17.18 6 33512 18 79710852
Arthritis 31.98 17.18 5 33513 114875 79595995
Myocardial infarction 31.76 17.18 19 33499 184110 79526760
Maternal exposure during pregnancy 31.75 17.18 9 33509 136529 79574341
Needle issue 31.68 17.18 33 33485 13035 79697835
Ganglioneuroma 30.76 17.18 8 33510 143 79710727
Wheezing 30.46 17.18 6 33512 116658 79594212
Crystal nephropathy 30.45 17.18 14 33504 1441 79709429
Glioma 30.40 17.18 11 33507 611 79710259
Cardiac failure congestive 30.26 17.18 11 33507 142391 79568479
Anxiety 30.18 17.18 36 33482 248476 79462394
Febrile bone marrow aplasia 30.00 17.18 32 33486 12988 79697882
Product dispensing error 29.51 17.18 32 33486 13231 79697639
Incoherent 29.38 17.18 25 33493 7667 79703203
Sialoadenitis 29.06 17.18 15 33503 1986 79708884
Metastases to bone 28.87 17.18 43 33475 24384 79686486
Blood pressure diastolic increased 28.77 17.18 33 33485 14509 79696361
Cardiac failure 28.11 17.18 15 33503 154827 79556043
Neutrophil count decreased 27.93 17.18 95 33423 93864 79617006
Diffuse large B-cell lymphoma recurrent 27.89 17.18 19 33499 4188 79706682
Astrocytoma 27.39 17.18 8 33510 223 79710647
Facial asymmetry 27.36 17.18 11 33507 815 79710055
Hospitalisation 26.89 17.18 94 33424 94142 79616728
Bone marrow disorder 26.79 17.18 17 33501 3326 79707544
Vulval disorder 26.77 17.18 10 33508 608 79710262
Alanine aminotransferase increased 26.70 17.18 137 33381 162433 79548437
Cerebral haemorrhage 26.41 17.18 68 33450 57605 79653265
Optic neuropathy 26.15 17.18 17 33501 3467 79707403
Dehydration 25.98 17.18 186 33332 248001 79462869
Hypersensitivity 25.88 17.18 44 33474 262195 79448675
Myalgia 25.78 17.18 24 33494 185617 79525253
Hyperhidrosis 25.61 17.18 16 33502 151476 79559394
Craniotomy 25.57 17.18 9 33509 461 79710409
Hippocampal sclerosis 25.54 17.18 7 33511 154 79710716
Pain in extremity 25.46 17.18 74 33444 364464 79346406
Ataxia 25.29 17.18 41 33477 24998 79685872
Body temperature decreased 25.12 17.18 47 33471 32098 79678772
Anaplastic astrocytoma 25.08 17.18 7 33511 165 79710705
Drug resistance 24.99 17.18 55 33463 42158 79668712
Asthenia 24.85 17.18 326 33192 511363 79199507
Malaise 24.04 17.18 115 33403 489754 79221116
Tumour necrosis 23.93 17.18 13 33505 1909 79708961
Dizziness 23.89 17.18 127 33391 526314 79184556
Muscle swelling 23.73 17.18 10 33508 835 79710035
Drug intolerance 23.68 17.18 47 33471 264072 79446798
Depression 23.65 17.18 34 33484 216756 79494114
Rhabdomyolysis 23.60 17.18 7 33511 103124 79607746
Product dose omission issue 23.10 17.18 43 33475 247494 79463376
Epilepsy 22.80 17.18 52 33466 40808 79670062
Drug reaction with eosinophilia and systemic symptoms 22.76 17.18 69 33449 64175 79646695
Gastroenteropancreatic neuroendocrine tumour disease 22.58 17.18 5 33513 43 79710827
Hyperglycaemia 22.58 17.18 73 33445 70262 79640608
Psoriasis 22.58 17.18 5 33513 89582 79621288
Hyperkalaemia 22.40 17.18 10 33508 114388 79596482
DNA mismatch repair protein gene mutation 22.39 17.18 4 33514 9 79710861
COVID-19 22.34 17.18 20 33498 157654 79553216
Inflammation 22.13 17.18 6 33512 93747 79617123
Swelling 21.71 17.18 36 33482 216675 79494195
Oligodendroglioma 21.44 17.18 6 33512 143 79710727
Radiation interaction 21 17.18 5 33513 61 79710809
Electrocardiogram QT prolonged 20.93 17.18 6 33512 90380 79620490
Primary progressive aphasia 20.33 17.18 3 33515 0 79710870
Acute myeloid leukaemia 20.31 17.18 42 33476 30843 79680027
Organising pneumonia 20.26 17.18 24 33494 10915 79699955
Suicide attempt 20.16 17.18 5 33513 82927 79627943
Influenza 20.15 17.18 15 33503 129591 79581279
Intracranial pressure increased 20.14 17.18 21 33497 8301 79702569
Monocyte count decreased 20.14 17.18 14 33504 3187 79707683
Encephalomalacia 20.06 17.18 10 33508 1231 79709639
Acute myocardial infarction 20.03 17.18 4 33514 77032 79633838
Cerebrospinal fluid leakage 19.80 17.18 11 33507 1688 79709182
Suicidal ideation 19.77 17.18 4 33514 76336 79634534
Gastritis fungal 19.75 17.18 6 33512 192 79710678
Breast necrosis 19.74 17.18 5 33513 80 79710790
Weight increased 19.58 17.18 56 33462 277330 79433540
Chronic obstructive pulmonary disease 19.18 17.18 6 33512 85413 79625457
Product use issue 19.00 17.18 152 33366 209670 79501200
Atrial fibrillation 18.80 17.18 34 33484 197852 79513018
Early satiety 18.66 17.18 10 33508 1429 79709441
Back pain 18.27 17.18 66 33452 304114 79406756
Porokeratosis 18.10 17.18 6 33512 256 79710614
Bronchitis 18.00 17.18 17 33501 130627 79580243
Acute hepatitis B 17.90 17.18 7 33511 482 79710388
Neurological decompensation 17.90 17.18 16 33502 5237 79705633
Coronary artery disease 17.88 17.18 3 33515 65471 79645399
Nasal congestion 17.88 17.18 5 33513 76547 79634323
Meningitis 17.71 17.18 21 33497 9561 79701309
Food protein-induced enterocolitis syndrome 17.71 17.18 4 33514 38 79710832
Angioedema 17.70 17.18 5 33513 76030 79634840
Intussusception 17.66 17.18 9 33509 1161 79709709
Meningitis bacterial 17.31 17.18 12 33506 2720 79708150
Infrequent bowel movements 17.22 17.18 10 33508 1669 79709201

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

DiseaseRelationSNOMED_IDDOID
Astrocytoma, anaplastic indication 55353007 DOID:3078
Glioma, malignant indication 74532006
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 0085-1366 CAPSULE 100 mg ORAL NDA 33 sections
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 0085-1381 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 2.50 mg INTRAVENOUS 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 0085-1417 CAPSULE 250 mg ORAL 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 0085-1425 CAPSULE 140 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 0085-1430 CAPSULE 180 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 0085-1519 CAPSULE 20 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
TEMODAR HUMAN PRESCRIPTION DRUG LABEL 1 0085-3004 CAPSULE 5 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 0781-2691 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