temozolomide 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| 2589 | 85622-93-1 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
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.
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
None
ADMET properties:
| Property | Value | Reference |
|---|---|---|
| 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 µM/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:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| 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 term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients 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 term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients 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 term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients 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:
| Source | Code | Description |
|---|---|---|
| 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|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| 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 |
🐶 Veterinary Drug Use
None
🐶 Veterinary products
None
Acid dissociation constants calculated using MoKa v3.0.0
| Dissociation level | Dissociation constant | Type (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:
| ID | Source |
|---|---|
| 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:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| 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 |