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temozolomide 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | 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 |
Predicted pharmacokinetic/toxicological properties (PK-AZ):
| Property | Description | Value | Unit | Confidence | Similarity |
|---|---|---|---|---|---|
| azlogd74 | LogD at pH 7.4 | -0.873 | High | 1 | |
| caco2-efflux | Caco-2 efflux ratio (BA/AB) | 0.782 | High | 1 | |
| caco2-intrinsic-papp | Caco-2 intrinsic apparent permeability | 25.763 | 10^-6 cm/s | High | 1 |
| dh-clint | Dog hepatocyte intrinsic clearance | 11.169 | uL/min/10^6 cells | High | 1 |
| dppb | Dog plasma protein binding (% unbound) | 92.800 | % | High | 1 |
| fcs-ppb | Fetal calf serum protein binding (% unbound) | 93.640 | % | High | 1 |
| herg | hERG pIC50 | 3.632 | pIC50 | High | 1 |
| hh-clint | Human hepatocyte intrinsic clearance | 5.728 | uL/min/10^6 cells | High | 1 |
| hlm-clint | Human liver microsomal intrinsic clearance | 3.034 | uL/min/mg protein | High | 1 |
| hppb | Human plasma protein binding (% unbound) | 83.140 | % | High | 1 |
| kinase-safety-class | ACVR2A,ACVR2B,AXL,BRAF,CAMK2D,CDK9,DDR1,DYRK1B,EIF2AK3,ERBB2,GRK2,MAP3K21,MAPK7,PDK1,PIK3CD,PRKDC,SIK2,TEK | 18 | |||
| kinase-selectivity-class | GRK2 | 1 | |||
| mdck-mdr1-bcrp-efflux | MDCK-MDR1-BCRP efflux ratio | 1.233 | High | 1 | |
| mdck-mdr1-efflux | MDCK-MDR1 efflux ratio | 5.728 | High | 1 | |
| mh-clint | Mouse hepatocyte intrinsic clearance | 25.763 | High | 1 | |
| mppb | Mouse plasma protein binding (% unbound) | 88.520 | High | 1 | |
| nih-mdck-mdr1-efflux | NIH MDCK-MDR1 efflux ratio | 3.214 | High | 1 | |
| pfas-class | PFAS structural alert (1 = True, 0 = False) | 0 | |||
| pppb | Pig plasma protein binding (% unbound) | 87.470 | % | High | 1 |
| rat-kpuu-brain | Rat brain Kpuu | 0.673 | % | High | 1 |
| rh-clint | Rat hepatocyte intrinsic clearance | 9.594 | uL/min/10^6 cells | High | 1 |
| rh-fuinc | Rat hepatocyte fraction unbound in incubation | 98.860 | % | High | 1 |
| rppb | Rat plasma protein binding (% unbound) | 76.890 | % | High | 1 |
| solubility-dd | Solubility at pH 7.4 in DMSO | 1028.016 | uM | High | 1 |
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 |
|---|---|---|---|---|---|---|
| Disease progression | 1002.14 | 23.03 | 574 | 22533 | 156041 | 90449299 |
| Thrombocytopenia | 874.36 | 23.03 | 584 | 22523 | 208141 | 90397199 |
| Malignant neoplasm progression | 653.98 | 23.03 | 381 | 22726 | 106489 | 90498851 |
| Product use in unapproved indication | 562.75 | 23.03 | 550 | 22557 | 335686 | 90269654 |
| Pancytopenia | 407.32 | 23.03 | 296 | 22811 | 119967 | 90485373 |
| Tumour pseudoprogression | 376.15 | 23.03 | 75 | 23032 | 646 | 90604694 |
| Hypermutation | 362.89 | 23.03 | 52 | 23055 | 18 | 90605322 |
| Death | 313.61 | 23.03 | 476 | 22631 | 456075 | 90149265 |
| Neoplasm progression | 302.12 | 23.03 | 170 | 22937 | 44316 | 90561024 |
| Neutropenia | 256.71 | 23.03 | 301 | 22806 | 224603 | 90380737 |
| Off label use | 253.29 | 23.03 | 731 | 22376 | 1101521 | 89503819 |
| Bone marrow failure | 245.87 | 23.03 | 133 | 22974 | 32088 | 90573252 |
| Lymphopenia | 236.93 | 23.03 | 116 | 22991 | 22765 | 90582575 |
| Seizure | 236.42 | 23.03 | 240 | 22867 | 152389 | 90452951 |
| Myelosuppression | 213.90 | 23.03 | 146 | 22961 | 53445 | 90551895 |
| Platelet count decreased | 198.73 | 23.03 | 208 | 22899 | 136761 | 90468579 |
| Metastases to liver | 187.20 | 23.03 | 107 | 23000 | 28700 | 90576640 |
| Febrile neutropenia | 172.33 | 23.03 | 207 | 22900 | 158142 | 90447198 |
| Haematotoxicity | 168.14 | 23.03 | 76 | 23031 | 12459 | 90592881 |
| Vasogenic cerebral oedema | 157.21 | 23.03 | 41 | 23066 | 1249 | 90604091 |
| Therapy partial responder | 157.10 | 23.03 | 87 | 23020 | 21956 | 90583384 |
| Disease recurrence | 151.20 | 23.03 | 103 | 23004 | 37550 | 90567790 |
| Aplastic anaemia | 130.58 | 23.03 | 65 | 23042 | 13204 | 90592136 |
| Eastern Cooperative Oncology Group performance status worsened | 123.19 | 23.03 | 37 | 23070 | 1902 | 90603438 |
| Leukopenia | 113.33 | 23.03 | 134 | 22973 | 100576 | 90504764 |
| Brain oedema | 111.38 | 23.03 | 64 | 23043 | 17321 | 90588019 |
| Hospice care | 105.85 | 23.03 | 51 | 23056 | 9653 | 90595687 |
| Joint swelling | 101.28 | 23.03 | 7 | 23100 | 503293 | 90102047 |
| Glioblastoma multiforme | 91.49 | 23.03 | 25 | 23082 | 913 | 90604427 |
| Herpes simplex encephalitis | 84.57 | 23.03 | 20 | 23087 | 403 | 90604937 |
| Radiation necrosis | 80.13 | 23.03 | 21 | 23086 | 652 | 90604688 |
| Metastases to central nervous system | 77.65 | 23.03 | 51 | 23056 | 17491 | 90587849 |
| Glioblastoma | 77.61 | 23.03 | 22 | 23085 | 921 | 90604419 |
| Nausea | 75.63 | 23.03 | 512 | 22595 | 1109804 | 89495536 |
| Pulmonary embolism | 75.01 | 23.03 | 126 | 22981 | 130694 | 90474646 |
| Diffuse large B-cell lymphoma recurrent | 72.66 | 23.03 | 29 | 23078 | 3497 | 90601843 |
| Hemiparesis | 72.27 | 23.03 | 62 | 23045 | 31757 | 90573583 |
| Infusion related reaction | 70.51 | 23.03 | 11 | 23096 | 416769 | 90188571 |
| Metastases to peritoneum | 68.06 | 23.03 | 29 | 23078 | 4126 | 90601214 |
| Glossodynia | 66.09 | 23.03 | 4 | 23103 | 321775 | 90283565 |
| Neurological symptom | 65.77 | 23.03 | 33 | 23074 | 6814 | 90598526 |
| Recurrent cancer | 64.12 | 23.03 | 24 | 23083 | 2435 | 90602905 |
| Brain neoplasm | 63.67 | 23.03 | 29 | 23078 | 4835 | 90600505 |
| Wound | 61.52 | 23.03 | 4 | 23103 | 302976 | 90302364 |
| Eastern Cooperative Oncology Group performance status improved | 59.24 | 23.03 | 9 | 23098 | 9 | 90605331 |
| Arthralgia | 59.11 | 23.03 | 67 | 23040 | 778455 | 89826885 |
| Angina bullosa haemorrhagica | 58.46 | 23.03 | 12 | 23095 | 121 | 90605219 |
| Ascites | 56.12 | 23.03 | 65 | 23042 | 47675 | 90557665 |
| Sinusitis | 55.92 | 23.03 | 10 | 23097 | 343078 | 90262262 |
| Abdominal discomfort | 52.75 | 23.03 | 28 | 23079 | 477300 | 90128040 |
| Neoplasm recurrence | 50.92 | 23.03 | 22 | 23085 | 3237 | 90602103 |
| Malignant glioma | 50.48 | 23.03 | 8 | 23099 | 13 | 90605327 |
| Sepsis | 50.45 | 23.03 | 129 | 22978 | 179685 | 90425655 |
| Disseminated cryptococcosis | 50.26 | 23.03 | 15 | 23092 | 754 | 90604586 |
| Swelling | 50.23 | 23.03 | 22 | 23085 | 419036 | 90186304 |
| Central nervous system necrosis | 49.82 | 23.03 | 11 | 23096 | 161 | 90605179 |
| Maternal exposure during pregnancy | 49.76 | 23.03 | 15 | 23092 | 360048 | 90245292 |
| Asthma | 49.74 | 23.03 | 3 | 23104 | 242157 | 90363183 |
| Musculoskeletal stiffness | 49.74 | 23.03 | 8 | 23099 | 296524 | 90308816 |
| Metastases to lymph nodes | 49.35 | 23.03 | 33 | 23074 | 11656 | 90593684 |
| Peripheral swelling | 49.03 | 23.03 | 22 | 23085 | 413084 | 90192256 |
| Pneumocystis jirovecii pneumonia | 48.84 | 23.03 | 42 | 23065 | 21574 | 90583766 |
| Metastasis | 48.65 | 23.03 | 26 | 23081 | 6111 | 90599229 |
| Vomiting | 47.88 | 23.03 | 354 | 22753 | 787939 | 89817401 |
| Mental status changes | 47.84 | 23.03 | 58 | 23049 | 44621 | 90560719 |
| Brain neoplasm malignant | 47.10 | 23.03 | 16 | 23091 | 1225 | 90604115 |
| White blood cell count decreased | 46.99 | 23.03 | 120 | 22987 | 166989 | 90438351 |
| Pain | 46.73 | 23.03 | 117 | 22990 | 996224 | 89609116 |
| Magnetic resonance imaging head abnormal | 45.74 | 23.03 | 19 | 23088 | 2537 | 90602803 |
| Drug resistance | 45.43 | 23.03 | 47 | 23060 | 30402 | 90574938 |
| Agranulocytosis | 45.12 | 23.03 | 50 | 23057 | 34952 | 90570388 |
| Drug hypersensitivity | 44.55 | 23.03 | 32 | 23075 | 463577 | 90141763 |
| Hydrocephalus | 43.26 | 23.03 | 24 | 23083 | 6070 | 90599270 |
| Blood cholesterol increased | 41.47 | 23.03 | 3 | 23104 | 208009 | 90397331 |
| Gliosarcoma | 41.22 | 23.03 | 6 | 23101 | 3 | 90605337 |
| Platelet transfusion | 40.78 | 23.03 | 14 | 23093 | 1106 | 90604234 |
| Ganglioneuroma | 40.74 | 23.03 | 9 | 23098 | 132 | 90605208 |
| Muscle swelling | 40.50 | 23.03 | 12 | 23095 | 588 | 90604752 |
| Acute myeloid leukaemia | 40.45 | 23.03 | 37 | 23070 | 20603 | 90584737 |
| Crystal nephropathy | 40.41 | 23.03 | 14 | 23093 | 1137 | 90604203 |
| Corneal toxicity | 40.10 | 23.03 | 8 | 23099 | 69 | 90605271 |
| Dehydration | 39.38 | 23.03 | 124 | 22983 | 194323 | 90411017 |
| Facial asymmetry | 39.16 | 23.03 | 13 | 23094 | 927 | 90604413 |
| Petechiae | 38.47 | 23.03 | 32 | 23075 | 15709 | 90589631 |
| Blister | 38.29 | 23.03 | 9 | 23098 | 254989 | 90350351 |
| Product administered to patient of inappropriate age | 37.69 | 23.03 | 20 | 23087 | 4633 | 90600707 |
| DNA mismatch repair protein gene mutation | 36.37 | 23.03 | 5 | 23102 | 0 | 90605340 |
| Enterocutaneous fistula | 36.13 | 23.03 | 14 | 23093 | 1560 | 90603780 |
| Jaw operation | 36.10 | 23.03 | 12 | 23095 | 859 | 90604481 |
| Deep vein thrombosis | 35.90 | 23.03 | 75 | 23032 | 91545 | 90513795 |
| Rhabdoid tumour | 35.78 | 23.03 | 7 | 23100 | 54 | 90605286 |
| Discomfort | 35.14 | 23.03 | 13 | 23094 | 274322 | 90331018 |
| Optic neuropathy | 35.04 | 23.03 | 16 | 23091 | 2682 | 90602658 |
| Migraine | 34.60 | 23.03 | 4 | 23103 | 190388 | 90414952 |
| Hepatic enzyme increased | 34.51 | 23.03 | 25 | 23082 | 360711 | 90244629 |
| Anaemia | 34.30 | 23.03 | 179 | 22928 | 352623 | 90252717 |
| Nasopharyngitis | 34.25 | 23.03 | 32 | 23075 | 407072 | 90198268 |
| Early satiety | 34.03 | 23.03 | 13 | 23094 | 1394 | 90603946 |
| Therapy change | 33.95 | 23.03 | 23 | 23084 | 8299 | 90597041 |
| Metastases to bone | 33.85 | 23.03 | 37 | 23070 | 25468 | 90579872 |
| Lymphocyte count decreased | 33.52 | 23.03 | 43 | 23064 | 35007 | 90570333 |
| Weight increased | 32.70 | 23.03 | 35 | 23072 | 417892 | 90187448 |
| Asthenia | 32.49 | 23.03 | 240 | 22867 | 533511 | 90071829 |
| Drug ineffective | 32.35 | 23.03 | 513 | 22594 | 1383785 | 89221555 |
| Therapy cessation | 32.27 | 23.03 | 43 | 23064 | 36318 | 90569022 |
| Sialoadenitis | 31.72 | 23.03 | 14 | 23093 | 2168 | 90603172 |
| Anxiety | 31.59 | 23.03 | 20 | 23087 | 309752 | 90295588 |
| Hypersensitivity | 31.40 | 23.03 | 42 | 23065 | 454635 | 90150705 |
| Neutrophil count abnormal | 31.35 | 23.03 | 17 | 23090 | 4111 | 90601229 |
| Vulval disorder | 31.02 | 23.03 | 12 | 23095 | 1332 | 90604008 |
| Renal-limited thrombotic microangiopathy | 30.95 | 23.03 | 8 | 23099 | 235 | 90605105 |
| Type 2 diabetes mellitus | 30.85 | 23.03 | 7 | 23100 | 203237 | 90402103 |
| Glioma | 30.56 | 23.03 | 9 | 23098 | 432 | 90604908 |
| Metastases to lung | 30.04 | 23.03 | 28 | 23079 | 15963 | 90589377 |
| Lethargy | 29.95 | 23.03 | 56 | 23051 | 63083 | 90542257 |
| Cerebral haemorrhage | 29.38 | 23.03 | 40 | 23067 | 34482 | 90570858 |
| Primary progressive aphasia | 29.10 | 23.03 | 4 | 23103 | 0 | 90605340 |
| Metastatic malignant melanoma | 28.82 | 23.03 | 12 | 23095 | 1612 | 90603728 |
| Mobility decreased | 28.72 | 23.03 | 14 | 23093 | 250720 | 90354620 |
| Diffuse large B-cell lymphoma | 28.55 | 23.03 | 21 | 23086 | 8624 | 90596716 |
| Impaired healing | 28.51 | 23.03 | 12 | 23095 | 234187 | 90371153 |
| Blood disorder | 28.18 | 23.03 | 20 | 23087 | 7770 | 90597570 |
| Penetrating aortic ulcer | 27.95 | 23.03 | 5 | 23102 | 22 | 90605318 |
| Constipation | 27.74 | 23.03 | 143 | 22964 | 280252 | 90325088 |
| Disorientation | 27.29 | 23.03 | 44 | 23063 | 44070 | 90561270 |
| Depression | 27.25 | 23.03 | 22 | 23085 | 300579 | 90304761 |
| Psoriasis | 27.11 | 23.03 | 3 | 23104 | 147751 | 90457589 |
| Arthritis | 26.97 | 23.03 | 5 | 23102 | 167310 | 90438030 |
| Gastrooesophageal reflux disease | 26.75 | 23.03 | 5 | 23102 | 166332 | 90439008 |
| White blood cell count abnormal | 26.54 | 23.03 | 19 | 23088 | 7485 | 90597855 |
| Malaise | 26.47 | 23.03 | 70 | 23037 | 585916 | 90019424 |
| Oesophagitis | 26.41 | 23.03 | 27 | 23080 | 17222 | 90588118 |
| Medulloblastoma recurrent | 26.06 | 23.03 | 6 | 23101 | 107 | 90605233 |
| Mucosal inflammation | 25.95 | 23.03 | 50 | 23057 | 57575 | 90547765 |
| Intracranial tumour haemorrhage | 25.87 | 23.03 | 7 | 23100 | 246 | 90605094 |
| Gastroenteropancreatic neuroendocrine tumour disease | 25.74 | 23.03 | 5 | 23102 | 37 | 90605303 |
| Myelodysplastic syndrome | 25.47 | 23.03 | 29 | 23078 | 20874 | 90584466 |
| Needle issue | 25.41 | 23.03 | 24 | 23083 | 13910 | 90591430 |
| Coagulation time prolonged | 25.07 | 23.03 | 11 | 23096 | 1679 | 90603661 |
| Alopecia | 24.01 | 23.03 | 57 | 23050 | 495014 | 90110326 |
| Neutrophil count decreased | 23.98 | 23.03 | 55 | 23052 | 71477 | 90533863 |
| Drug clearance decreased | 23.85 | 23.03 | 11 | 23096 | 1887 | 90603453 |
| Drug intolerance | 23.79 | 23.03 | 49 | 23058 | 447542 | 90157798 |
| Dyspnoea | 23.72 | 23.03 | 130 | 22977 | 880825 | 89724515 |
| Metastases to bone marrow | 23.57 | 23.03 | 8 | 23099 | 611 | 90604729 |
| Lung infiltration | 23.54 | 23.03 | 24 | 23083 | 15258 | 90590082 |
| Condition aggravated | 23.37 | 23.03 | 76 | 23031 | 595469 | 90009871 |
| Tumour necrosis | 23.32 | 23.03 | 9 | 23098 | 992 | 90604348 |
| Acute hepatitis B | 23.26 | 23.03 | 7 | 23100 | 362 | 90604978 |
| Gastritis fungal | 23.25 | 23.03 | 6 | 23101 | 175 | 90605165 |
| Cryptococcosis | 23.21 | 23.03 | 10 | 23097 | 1461 | 90603879 |
| Pneumonia fungal | 23.04 | 23.03 | 17 | 23090 | 7014 | 90598326 |
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 | 1120.76 | 18.33 | 794 | 22889 | 142862 | 42454790 |
| Product use in unapproved indication | 674.57 | 18.33 | 658 | 23025 | 183798 | 42413854 |
| Malignant neoplasm progression | 358.45 | 18.33 | 367 | 23316 | 108033 | 42489619 |
| Tumour pseudoprogression | 344.15 | 18.33 | 86 | 23597 | 964 | 42596688 |
| Thrombocytopenia | 307.09 | 18.33 | 448 | 23235 | 189831 | 42407821 |
| Neoplasm progression | 275.92 | 18.33 | 182 | 23501 | 28818 | 42568834 |
| Hypermutation | 257.90 | 18.33 | 42 | 23641 | 18 | 42597634 |
| Seizure | 239.37 | 18.33 | 314 | 23369 | 120247 | 42477405 |
| Lymphopenia | 238.94 | 18.33 | 149 | 23534 | 21414 | 42576238 |
| Death | 203.34 | 18.33 | 647 | 23036 | 470538 | 42127114 |
| Nausea | 179.29 | 18.33 | 554 | 23129 | 396245 | 42201407 |
| Myelosuppression | 142.50 | 18.33 | 142 | 23541 | 40319 | 42557333 |
| Recurrent cancer | 134.45 | 18.33 | 46 | 23637 | 1627 | 42596025 |
| Disease recurrence | 130.92 | 18.33 | 118 | 23565 | 29560 | 42568092 |
| Off label use | 125.58 | 18.33 | 689 | 22994 | 637646 | 41960006 |
| Vanishing bile duct syndrome | 121.87 | 18.33 | 44 | 23639 | 1827 | 42595825 |
| Glioblastoma | 109.66 | 18.33 | 38 | 23645 | 1397 | 42596255 |
| Vomiting | 104.92 | 18.33 | 376 | 23307 | 289347 | 42308305 |
| Cholestatic liver injury | 89.73 | 18.33 | 43 | 23640 | 3666 | 42593986 |
| Metastases to liver | 88.39 | 18.33 | 73 | 23610 | 16253 | 42581399 |
| Hemiparesis | 84.42 | 18.33 | 73 | 23610 | 17303 | 42580349 |
| Brain operation | 82.23 | 18.33 | 24 | 23659 | 499 | 42597153 |
| Brain oedema | 82.18 | 18.33 | 70 | 23613 | 16257 | 42581395 |
| Hospice care | 79.84 | 18.33 | 53 | 23630 | 8460 | 42589192 |
| Constipation | 74.06 | 18.33 | 228 | 23455 | 162063 | 42435589 |
| Therapy partial responder | 73.66 | 18.33 | 72 | 23611 | 19949 | 42577703 |
| Radiation necrosis | 73.43 | 18.33 | 19 | 23664 | 247 | 42597405 |
| Eastern Cooperative Oncology Group performance status worsened | 70.79 | 18.33 | 27 | 23656 | 1309 | 42596343 |
| Malignant glioma | 68.33 | 18.33 | 13 | 23670 | 32 | 42597620 |
| Aphasia | 66.01 | 18.33 | 74 | 23609 | 24009 | 42573643 |
| Haematotoxicity | 65.55 | 18.33 | 52 | 23631 | 10933 | 42586719 |
| Fatigue | 62.83 | 18.33 | 435 | 23248 | 435206 | 42162446 |
| Metastases to lung | 61.66 | 18.33 | 51 | 23632 | 11373 | 42586279 |
| Product use issue | 61.09 | 18.33 | 133 | 23550 | 76618 | 42521034 |
| Hydrocephalus | 59.82 | 18.33 | 39 | 23644 | 6039 | 42591613 |
| Neoplasm recurrence | 58.16 | 18.33 | 29 | 23654 | 2695 | 42594957 |
| Drug ineffective | 54.04 | 18.33 | 560 | 23123 | 629637 | 41968015 |
| Intracranial tumour haemorrhage | 52.49 | 18.33 | 16 | 23667 | 388 | 42597264 |
| Neutropenia | 52.04 | 18.33 | 234 | 23449 | 199197 | 42398455 |
| Diaphragmatic spasm | 50.79 | 18.33 | 12 | 23671 | 104 | 42597548 |
| Product administered to patient of inappropriate age | 50.44 | 18.33 | 32 | 23651 | 4729 | 42592923 |
| Brain neoplasm | 48.14 | 18.33 | 28 | 23655 | 3540 | 42594112 |
| Glioblastoma multiforme | 47.36 | 18.33 | 18 | 23665 | 864 | 42596788 |
| Pancytopenia | 45.16 | 18.33 | 156 | 23527 | 117587 | 42480065 |
| Diabetes insipidus | 44.51 | 18.33 | 27 | 23656 | 3686 | 42593966 |
| Arthralgia | 44.13 | 18.33 | 30 | 23653 | 205208 | 42392444 |
| Metastases to lymph nodes | 43.73 | 18.33 | 32 | 23651 | 5966 | 42591686 |
| Metastases to peritoneum | 43.40 | 18.33 | 23 | 23660 | 2426 | 42595226 |
| Pancreatic neuroendocrine tumour metastatic | 43.39 | 18.33 | 11 | 23672 | 131 | 42597521 |
| Faecal volume decreased | 43.06 | 18.33 | 12 | 23671 | 210 | 42597442 |
| Metastases to meninges | 42.23 | 18.33 | 21 | 23662 | 1940 | 42595712 |
| Pulmonary embolism | 40.36 | 18.33 | 152 | 23531 | 119460 | 42478192 |
| Dyspnoea | 38.74 | 18.33 | 122 | 23561 | 442499 | 42155153 |
| Platelet count decreased | 37.15 | 18.33 | 164 | 23519 | 138417 | 42459235 |
| Bone marrow failure | 36.78 | 18.33 | 66 | 23617 | 33027 | 42564625 |
| Metastasis | 36.35 | 18.33 | 26 | 23657 | 4679 | 42592973 |
| Brain tumour operation | 35.91 | 18.33 | 6 | 23677 | 4 | 42597648 |
| Metastases to central nervous system | 35.78 | 18.33 | 36 | 23647 | 10319 | 42587333 |
| Hepatic lesion | 35.10 | 18.33 | 25 | 23658 | 4469 | 42593183 |
| Myocardial infarction | 34.29 | 18.33 | 13 | 23670 | 123996 | 42473656 |
| Therapy cessation | 34.00 | 18.33 | 49 | 23634 | 20401 | 42577251 |
| Herpes simplex encephalitis | 32.58 | 18.33 | 11 | 23672 | 373 | 42597279 |
| Deep vein thrombosis | 32.17 | 18.33 | 105 | 23578 | 76852 | 42520800 |
| Intussusception | 31.99 | 18.33 | 13 | 23670 | 746 | 42596906 |
| Confusional state | 31.91 | 18.33 | 180 | 23503 | 167417 | 42430235 |
| Drug interaction | 31.56 | 18.33 | 63 | 23620 | 266936 | 42330716 |
| Magnetic resonance imaging head abnormal | 31.45 | 18.33 | 16 | 23667 | 1551 | 42596101 |
| Nasopharyngitis | 30.54 | 18.33 | 5 | 23678 | 83991 | 42513661 |
| Lymphocyte count decreased | 30.31 | 18.33 | 55 | 23628 | 27754 | 42569898 |
| Biliary obstruction | 30.02 | 18.33 | 20 | 23663 | 3209 | 42594443 |
| Astrocytoma | 29.81 | 18.33 | 9 | 23674 | 211 | 42597441 |
| Brain neoplasm malignant | 29.30 | 18.33 | 13 | 23670 | 928 | 42596724 |
| Radiation injury | 28.88 | 18.33 | 11 | 23672 | 531 | 42597121 |
| Epilepsy | 28.83 | 18.33 | 52 | 23631 | 26119 | 42571533 |
| Product dose omission issue | 28.82 | 18.33 | 26 | 23657 | 154339 | 42443313 |
| Acquired gene mutation | 28.46 | 18.33 | 15 | 23668 | 1565 | 42596087 |
| Parathyroid tumour malignant | 28.12 | 18.33 | 7 | 23676 | 77 | 42597575 |
| Atrial fibrillation | 27.91 | 18.33 | 22 | 23661 | 139571 | 42458081 |
| Bone marrow disorder | 27.89 | 18.33 | 16 | 23667 | 1970 | 42595682 |
| Tumour haemorrhage | 27.87 | 18.33 | 20 | 23663 | 3618 | 42594034 |
| Oligodendroglioma | 27.47 | 18.33 | 6 | 23677 | 35 | 42597617 |
| Metastases to bone | 26.87 | 18.33 | 37 | 23646 | 14772 | 42582880 |
| Swelling of eyelid | 26.87 | 18.33 | 16 | 23667 | 2112 | 42595540 |
| Nephrogenic diabetes insipidus | 25.70 | 18.33 | 14 | 23669 | 1560 | 42596092 |
| Cardiac failure congestive | 25.34 | 18.33 | 8 | 23675 | 85594 | 42512058 |
| Cardiac failure | 25.19 | 18.33 | 14 | 23669 | 106842 | 42490810 |
| COVID-19 | 24.83 | 18.33 | 17 | 23666 | 115931 | 42481721 |
| Hyperkalaemia | 24.76 | 18.33 | 7 | 23676 | 80451 | 42517201 |
| Rosacea | 24.67 | 18.33 | 13 | 23670 | 1355 | 42596297 |
| Pneumocystis jirovecii pneumonia | 23.96 | 18.33 | 47 | 23636 | 25134 | 42572518 |
| Acute kidney injury | 23.88 | 18.33 | 114 | 23569 | 367223 | 42230429 |
| Rhabdomyolysis | 23.62 | 18.33 | 7 | 23676 | 78012 | 42519640 |
| Medulloblastoma | 23.55 | 18.33 | 6 | 23677 | 73 | 42597579 |
| Hippocampal sclerosis | 23.48 | 18.33 | 7 | 23676 | 157 | 42597495 |
| Skin warm | 22.73 | 18.33 | 16 | 23667 | 2807 | 42594845 |
| Gait disturbance | 22.57 | 18.33 | 111 | 23572 | 97889 | 42499763 |
| Drug resistance | 22.43 | 18.33 | 55 | 23628 | 34193 | 42563459 |
| Paraparesis | 22.14 | 18.33 | 14 | 23669 | 2057 | 42595595 |
| Influenza | 21.94 | 18.33 | 4 | 23679 | 62171 | 42535481 |
| Anaplastic astrocytoma | 21.75 | 18.33 | 6 | 23677 | 101 | 42597551 |
| Metastases to spinal cord | 21.74 | 18.33 | 5 | 23678 | 38 | 42597614 |
| Xanthoma | 21.12 | 18.33 | 6 | 23677 | 113 | 42597539 |
| Neurological decompensation | 20.62 | 18.33 | 17 | 23666 | 3772 | 42593880 |
| Chest discomfort | 20.59 | 18.33 | 5 | 23678 | 63611 | 42534041 |
| Pruritus | 20.23 | 18.33 | 47 | 23636 | 188724 | 42408928 |
| Alexia | 20.20 | 18.33 | 4 | 23679 | 13 | 42597639 |
| Central nervous system necrosis | 20.08 | 18.33 | 7 | 23676 | 262 | 42597390 |
| Asthma | 19.97 | 18.33 | 5 | 23678 | 62309 | 42535343 |
| Blood pressure diastolic increased | 19.84 | 18.33 | 21 | 23662 | 6384 | 42591268 |
| Therapy non-responder | 19.82 | 18.33 | 70 | 23613 | 53289 | 42544363 |
| Feeling abnormal | 19.82 | 18.33 | 7 | 23676 | 69779 | 42527873 |
| Aplastic anaemia | 19.61 | 18.33 | 29 | 23654 | 12355 | 42585297 |
| Myxoid liposarcoma | 19.56 | 18.33 | 4 | 23679 | 16 | 42597636 |
| Therapy change | 19.47 | 18.33 | 17 | 23666 | 4078 | 42593574 |
| Hospitalisation | 19.16 | 18.33 | 87 | 23596 | 74243 | 42523409 |
| Glioma | 19.07 | 18.33 | 8 | 23675 | 498 | 42597154 |
| Generalised tonic-clonic seizure | 19.04 | 18.33 | 44 | 23639 | 26335 | 42571317 |
| Ataxia | 19.00 | 18.33 | 33 | 23650 | 16092 | 42581560 |
| Condition aggravated | 18.68 | 18.33 | 78 | 23605 | 260676 | 42336976 |
| Paraganglion neoplasm malignant | 18.67 | 18.33 | 4 | 23679 | 21 | 42597631 |
| Hypotension | 18.50 | 18.33 | 77 | 23606 | 257554 | 42340098 |
| Chronic obstructive pulmonary disease | 18.49 | 18.33 | 6 | 23677 | 63108 | 42534544 |
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 | 2036.57 | 18.22 | 1210 | 39692 | 242824 | 110305573 |
| Product use in unapproved indication | 1085.94 | 18.22 | 1061 | 39841 | 446316 | 110102081 |
| Thrombocytopenia | 1055.78 | 18.22 | 936 | 39966 | 347949 | 110200448 |
| Malignant neoplasm progression | 866.80 | 18.22 | 627 | 40275 | 173940 | 110374457 |
| Tumour pseudoprogression | 613.82 | 18.22 | 138 | 40764 | 1478 | 110546919 |
| Hypermutation | 565.09 | 18.22 | 86 | 40816 | 34 | 110548363 |
| Neoplasm progression | 553.60 | 18.22 | 327 | 40575 | 64268 | 110484129 |
| Death | 497.81 | 18.22 | 909 | 39993 | 697960 | 109850437 |
| Lymphopenia | 474.11 | 18.22 | 251 | 40651 | 39919 | 110508478 |
| Seizure | 370.19 | 18.22 | 432 | 40470 | 220753 | 110327644 |
| Disease recurrence | 318.56 | 18.22 | 226 | 40676 | 60558 | 110487839 |
| Pancytopenia | 297.90 | 18.22 | 377 | 40525 | 209236 | 110339161 |
| Off label use | 287.27 | 18.22 | 1202 | 39700 | 1498983 | 109049414 |
| Neutropenia | 258.90 | 18.22 | 482 | 40420 | 374138 | 110174259 |
| Myelosuppression | 258.22 | 18.22 | 240 | 40662 | 94100 | 110454297 |
| Therapy partial responder | 254.54 | 18.22 | 163 | 40739 | 36898 | 110511499 |
| Metastases to liver | 253.91 | 18.22 | 160 | 40742 | 35226 | 110513171 |
| Bone marrow failure | 218.69 | 18.22 | 177 | 40725 | 57671 | 110490726 |
| Haematotoxicity | 210.54 | 18.22 | 118 | 40784 | 20964 | 110527433 |
| Eastern Cooperative Oncology Group performance status worsened | 197.33 | 18.22 | 64 | 40838 | 2905 | 110545492 |
| Glioblastoma | 185.99 | 18.22 | 56 | 40846 | 1984 | 110546413 |
| Platelet count decreased | 176.13 | 18.22 | 310 | 40592 | 230133 | 110318264 |
| Nausea | 167.98 | 18.22 | 898 | 40004 | 1234792 | 109313605 |
| Recurrent cancer | 161.31 | 18.22 | 57 | 40845 | 3366 | 110545031 |
| Hospice care | 158.67 | 18.22 | 82 | 40820 | 12391 | 110536006 |
| Brain oedema | 154.54 | 18.22 | 112 | 40790 | 30986 | 110517411 |
| Vasogenic cerebral oedema | 147.33 | 18.22 | 48 | 40854 | 2210 | 110546187 |
| Febrile neutropenia | 145.40 | 18.22 | 345 | 40557 | 316422 | 110231975 |
| Product administered to patient of inappropriate age | 117.34 | 18.22 | 58 | 40844 | 7978 | 110540419 |
| Radiation necrosis | 116.11 | 18.22 | 32 | 40870 | 822 | 110547575 |
| Joint swelling | 115.63 | 18.22 | 14 | 40888 | 442831 | 110105566 |
| Hemiparesis | 114.88 | 18.22 | 109 | 40793 | 43794 | 110504603 |
| Metastases to peritoneum | 114.40 | 18.22 | 51 | 40851 | 5559 | 110542838 |
| Herpes simplex encephalitis | 111.83 | 18.22 | 31 | 40871 | 814 | 110547583 |
| Arthralgia | 110.23 | 18.22 | 77 | 40825 | 779555 | 109768842 |
| Aplastic anaemia | 106.12 | 18.22 | 81 | 40821 | 24227 | 110524170 |
| Hydrocephalus | 106.11 | 18.22 | 59 | 40843 | 10316 | 110538081 |
| Infusion related reaction | 104.73 | 18.22 | 10 | 40892 | 381152 | 110167245 |
| Malignant glioma | 101.01 | 18.22 | 19 | 40883 | 74 | 110548323 |
| Drug ineffective | 100.84 | 18.22 | 928 | 39974 | 1519612 | 109028785 |
| Metastases to central nervous system | 99.53 | 18.22 | 76 | 40826 | 22741 | 110525656 |
| Leukopenia | 99.45 | 18.22 | 189 | 40713 | 148602 | 110399795 |
| Glioblastoma multiforme | 98.54 | 18.22 | 32 | 40870 | 1458 | 110546939 |
| Metastases to lymph nodes | 95.54 | 18.22 | 63 | 40839 | 14969 | 110533428 |
| Vomiting | 94.27 | 18.22 | 617 | 40285 | 910058 | 109638339 |
| Vanishing bile duct syndrome | 91.93 | 18.22 | 37 | 40865 | 3131 | 110545266 |
| Constipation | 91.81 | 18.22 | 316 | 40586 | 357470 | 110190927 |
| Arthropathy | 89.35 | 18.22 | 4 | 40898 | 287518 | 110260879 |
| Metastasis | 87.25 | 18.22 | 48 | 40854 | 8219 | 110540178 |
| Pulmonary embolism | 86.04 | 18.22 | 222 | 40680 | 214252 | 110334145 |
| Neoplasm recurrence | 83.10 | 18.22 | 40 | 40862 | 5192 | 110543205 |
| Metastases to lung | 79.67 | 18.22 | 67 | 40835 | 22996 | 110525401 |
| Lymphocyte count decreased | 78.06 | 18.22 | 101 | 40801 | 57142 | 110491255 |
| Intracranial tumour haemorrhage | 77.81 | 18.22 | 22 | 40880 | 622 | 110547775 |
| Contraindicated product administered | 75.38 | 18.22 | 4 | 40898 | 248263 | 110300134 |
| Magnetic resonance imaging head abnormal | 71.64 | 18.22 | 32 | 40870 | 3503 | 110544894 |
| Therapeutic product effect decreased | 70.98 | 18.22 | 5 | 40897 | 244311 | 110304086 |
| Pneumocystis jirovecii pneumonia | 70.51 | 18.22 | 83 | 40819 | 42652 | 110505745 |
| Asthma | 70.25 | 18.22 | 6 | 40896 | 250285 | 110298112 |
| Wheezing | 69.28 | 18.22 | 7 | 40895 | 255223 | 110293174 |
| Wound | 67.52 | 18.22 | 5 | 40897 | 234432 | 110313965 |
| Brain neoplasm | 67.45 | 18.22 | 37 | 40865 | 6300 | 110542097 |
| Glossodynia | 66.10 | 18.22 | 4 | 40898 | 222000 | 110326397 |
| Musculoskeletal stiffness | 65.74 | 18.22 | 12 | 40890 | 279810 | 110268587 |
| Abdominal discomfort | 65.33 | 18.22 | 32 | 40870 | 393826 | 110154571 |
| Nasopharyngitis | 63.97 | 18.22 | 33 | 40869 | 394328 | 110154069 |
| Pain | 63.05 | 18.22 | 165 | 40737 | 954790 | 109593607 |
| Central nervous system necrosis | 61.93 | 18.22 | 17 | 40885 | 430 | 110547967 |
| Brain operation | 61.82 | 18.22 | 20 | 40882 | 900 | 110547497 |
| Metastases to bone | 60.37 | 18.22 | 66 | 40836 | 31306 | 110517091 |
| Diabetes insipidus | 58.15 | 18.22 | 34 | 40868 | 6536 | 110541861 |
| Dyspnoea | 57.69 | 18.22 | 213 | 40689 | 1106659 | 109441738 |
| Cholestatic liver injury | 57.05 | 18.22 | 35 | 40867 | 7341 | 110541056 |
| Eastern Cooperative Oncology Group performance status improved | 55.89 | 18.22 | 9 | 40893 | 9 | 110548388 |
| Sinusitis | 55.78 | 18.22 | 20 | 40882 | 296668 | 110251729 |
| Agranulocytosis | 54.94 | 18.22 | 89 | 40813 | 61671 | 110486726 |
| Diaphragmatic spasm | 54.85 | 18.22 | 12 | 40890 | 112 | 110548285 |
| Glioma | 54.40 | 18.22 | 18 | 40884 | 870 | 110547527 |
| Drug resistance | 53.95 | 18.22 | 84 | 40818 | 56290 | 110492107 |
| Maternal exposure during pregnancy | 53.65 | 18.22 | 14 | 40888 | 254869 | 110293528 |
| Aphasia | 52.45 | 18.22 | 85 | 40817 | 58912 | 110489485 |
| Platelet transfusion | 52.10 | 18.22 | 24 | 40878 | 2822 | 110545575 |
| Metastases to meninges | 52.00 | 18.22 | 29 | 40873 | 5099 | 110543298 |
| Therapy cessation | 51.79 | 18.22 | 73 | 40829 | 44784 | 110503613 |
| Brain neoplasm malignant | 51.27 | 18.22 | 21 | 40881 | 1859 | 110546538 |
| Inflammation | 50.66 | 18.22 | 6 | 40896 | 193232 | 110355165 |
| Hepatic lesion | 50.13 | 18.22 | 34 | 40868 | 8459 | 110539938 |
| Medulloblastoma recurrent | 49.03 | 18.22 | 12 | 40890 | 190 | 110548207 |
| Fatigue | 48.23 | 18.22 | 672 | 40230 | 1215286 | 109333111 |
| White blood cell count decreased | 47.36 | 18.22 | 189 | 40713 | 229201 | 110319196 |
| Petechiae | 46.52 | 18.22 | 50 | 40852 | 23267 | 110525130 |
| Swelling | 46.49 | 18.22 | 37 | 40865 | 351004 | 110197393 |
| Deep vein thrombosis | 46.30 | 18.22 | 135 | 40767 | 139752 | 110408645 |
| Brain tumour operation | 45.84 | 18.22 | 10 | 40892 | 92 | 110548305 |
| Blood cholesterol increased | 45.44 | 18.22 | 7 | 40895 | 184778 | 110363619 |
| Injury | 45.26 | 18.22 | 6 | 40896 | 177259 | 110371138 |
| Folliculitis | 44.46 | 18.22 | 5 | 40897 | 167648 | 110380749 |
| Acute myeloid leukaemia | 43.96 | 18.22 | 62 | 40840 | 38048 | 110510349 |
| Mental status changes | 42.79 | 18.22 | 90 | 40812 | 76032 | 110472365 |
| Arthritis | 42.01 | 18.22 | 6 | 40896 | 167580 | 110380817 |
| Neurological symptom | 41.29 | 18.22 | 39 | 40863 | 15569 | 110532828 |
| Astrocytoma | 41.23 | 18.22 | 11 | 40891 | 249 | 110548148 |
| Hepatic enzyme increased | 41.03 | 18.22 | 35 | 40867 | 320857 | 110227540 |
| Faecal volume decreased | 40.18 | 18.22 | 12 | 40890 | 413 | 110547984 |
| Malaise | 39.89 | 18.22 | 122 | 40780 | 671697 | 109876700 |
| Hypersensitivity | 39.56 | 18.22 | 55 | 40847 | 403943 | 110144454 |
| Gliosarcoma | 38.99 | 18.22 | 6 | 40896 | 3 | 110548394 |
| Peritumoural oedema | 38.88 | 18.22 | 7 | 40895 | 20 | 110548377 |
| Type 2 diabetes mellitus | 38.72 | 18.22 | 9 | 40893 | 177223 | 110371174 |
| Therapy change | 38.62 | 18.22 | 31 | 40871 | 9966 | 110538431 |
| Tumour haemorrhage | 38.32 | 18.22 | 24 | 40878 | 5221 | 110543176 |
| Mobility decreased | 38.28 | 18.22 | 20 | 40882 | 237402 | 110310995 |
| Angina bullosa haemorrhagica | 38.24 | 18.22 | 10 | 40892 | 209 | 110548188 |
| Pancreatic neuroendocrine tumour metastatic | 37.80 | 18.22 | 10 | 40892 | 219 | 110548178 |
| Acquired gene mutation | 37.62 | 18.22 | 19 | 40883 | 2735 | 110545662 |
| Oligodendroglioma | 36.86 | 18.22 | 9 | 40893 | 141 | 110548256 |
| Diffuse large B-cell lymphoma recurrent | 36.66 | 18.22 | 25 | 40877 | 6274 | 110542123 |
| Metastatic malignant melanoma | 36.54 | 18.22 | 20 | 40882 | 3389 | 110545008 |
| Drug hypersensitivity | 35.93 | 18.22 | 71 | 40831 | 454019 | 110094378 |
| Blister | 35.42 | 18.22 | 20 | 40882 | 227356 | 110321041 |
| Psoriasis | 35.12 | 18.22 | 5 | 40897 | 139988 | 110408409 |
| Migraine | 35.04 | 18.22 | 10 | 40892 | 171642 | 110376755 |
| Anxiety | 34.77 | 18.22 | 46 | 40856 | 345032 | 110203365 |
| Corneal toxicity | 34.66 | 18.22 | 8 | 40894 | 97 | 110548300 |
| C-reactive protein abnormal | 34.06 | 18.22 | 4 | 40898 | 129691 | 110418706 |
| Nephrogenic diabetes insipidus | 33.78 | 18.22 | 17 | 40885 | 2428 | 110545969 |
| Pain in extremity | 33.74 | 18.22 | 82 | 40820 | 487036 | 110061361 |
| Weight increased | 33.73 | 18.22 | 65 | 40837 | 419579 | 110128818 |
| Alanine aminotransferase increased | 33.67 | 18.22 | 146 | 40756 | 183627 | 110364770 |
| Condition aggravated | 33.41 | 18.22 | 149 | 40753 | 734687 | 109813710 |
| Radiation injury | 33.30 | 18.22 | 13 | 40889 | 1015 | 110547382 |
| Cerebral haemorrhage | 33.30 | 18.22 | 74 | 40828 | 64894 | 110483503 |
| Dehydration | 32.87 | 18.22 | 196 | 40706 | 279315 | 110269082 |
| Depression | 32.28 | 18.22 | 42 | 40860 | 317293 | 110231104 |
| Jaw operation | 32.10 | 18.22 | 12 | 40890 | 832 | 110547565 |
| Ganglioneuroma | 31.72 | 18.22 | 8 | 40894 | 144 | 110548253 |
| Product dose omission issue | 31.30 | 18.22 | 44 | 40858 | 321738 | 110226659 |
| Incoherent | 30.36 | 18.22 | 25 | 40877 | 8333 | 110540064 |
| Needle issue | 30.01 | 18.22 | 35 | 40867 | 17805 | 110530592 |
| Peripheral swelling | 29.58 | 18.22 | 66 | 40836 | 403968 | 110144429 |
| Neuroblastoma recurrent | 29.34 | 18.22 | 10 | 40892 | 530 | 110547867 |
| Discomfort | 29.21 | 18.22 | 22 | 40880 | 214685 | 110333712 |
| Crystal nephropathy | 28.90 | 18.22 | 14 | 40888 | 1842 | 110546555 |
| Sleep disorder | 28.81 | 18.22 | 19 | 40883 | 198625 | 110349772 |
| DNA mismatch repair protein gene mutation | 28.70 | 18.22 | 5 | 40897 | 11 | 110548386 |
| Gene mutation | 28.40 | 18.22 | 17 | 40885 | 3412 | 110544985 |
| Myocardial infarction | 28.37 | 18.22 | 18 | 40884 | 192065 | 110356332 |
| Optic neuropathy | 28.34 | 18.22 | 19 | 40883 | 4639 | 110543758 |
| Impaired healing | 28.28 | 18.22 | 19 | 40883 | 196698 | 110351699 |
| Tumour necrosis | 28.09 | 18.22 | 15 | 40887 | 2421 | 110545976 |
| Primary progressive aphasia | 27.61 | 18.22 | 4 | 40898 | 0 | 110548397 |
| Dizziness | 27.44 | 18.22 | 149 | 40753 | 698044 | 109850353 |
| Product dispensing error | 27.38 | 18.22 | 32 | 40870 | 16313 | 110532084 |
| Febrile bone marrow aplasia | 27.29 | 18.22 | 33 | 40869 | 17432 | 110530965 |
| Body temperature decreased | 27.26 | 18.22 | 49 | 40853 | 36886 | 110511511 |
| Facial asymmetry | 27.01 | 18.22 | 11 | 40891 | 959 | 110547438 |
| Cardiac failure congestive | 27.00 | 18.22 | 11 | 40891 | 150989 | 110397408 |
| Sepsis | 26.82 | 18.22 | 210 | 40692 | 327136 | 110221261 |
| Sialoadenitis | 26.78 | 18.22 | 15 | 40887 | 2658 | 110545739 |
| Anaplastic astrocytoma | 26.78 | 18.22 | 7 | 40895 | 146 | 110548251 |
| Road traffic accident | 26.56 | 18.22 | 4 | 40898 | 107394 | 110441003 |
| Muscle spasms | 26.10 | 18.22 | 39 | 40863 | 278118 | 110270279 |
| Parathyroid tumour malignant | 26.05 | 18.22 | 7 | 40895 | 163 | 110548234 |
| Drug reaction with eosinophilia and systemic symptoms | 25.98 | 18.22 | 78 | 40824 | 82017 | 110466380 |
| Myelodysplastic syndrome | 25.49 | 18.22 | 48 | 40854 | 37436 | 110510961 |
| Renal-limited thrombotic microangiopathy | 25.34 | 18.22 | 9 | 40893 | 539 | 110547858 |
| Blood pressure diastolic increased | 25.34 | 18.22 | 33 | 40869 | 18774 | 110529623 |
| Dry mouth | 25.31 | 18.22 | 22 | 40880 | 199926 | 110348471 |
| Bone marrow disorder | 25.15 | 18.22 | 17 | 40885 | 4206 | 110544191 |
| Lung disorder | 25.07 | 18.22 | 18 | 40884 | 180029 | 110368368 |
| Ataxia | 24.90 | 18.22 | 42 | 40860 | 30066 | 110518331 |
| Craniotomy | 24.35 | 18.22 | 9 | 40893 | 605 | 110547792 |
| Hippocampal sclerosis | 24.30 | 18.22 | 7 | 40895 | 212 | 110548185 |
| Vulval disorder | 24.22 | 18.22 | 10 | 40892 | 903 | 110547494 |
| Cholestasis | 24.02 | 18.22 | 65 | 40837 | 64453 | 110483944 |
| Drug intolerance | 23.96 | 18.22 | 74 | 40828 | 406438 | 110141959 |
| Sciatica | 23.89 | 18.22 | 3 | 40899 | 92396 | 110456001 |
| Penetrating aortic ulcer | 23.77 | 18.22 | 5 | 40897 | 38 | 110548359 |
| Asthenia | 23.73 | 18.22 | 372 | 40530 | 688627 | 109859770 |
| Neutrophil count decreased | 23.63 | 18.22 | 98 | 40804 | 120843 | 110427554 |
| Nasal congestion | 23.54 | 18.22 | 4 | 40898 | 98278 | 110450119 |
| Haemorrhage intracranial | 23.42 | 18.22 | 40 | 40862 | 28929 | 110519468 |
| Musculoskeletal pain | 23.34 | 18.22 | 20 | 40882 | 183003 | 110365394 |
| Cardiac failure | 23.32 | 18.22 | 21 | 40881 | 187605 | 110360792 |
| Hyperhidrosis | 23.24 | 18.22 | 21 | 40881 | 187277 | 110361120 |
| Suicide attempt | 23.08 | 18.22 | 5 | 40897 | 103389 | 110445008 |
| Myalgia | 23.05 | 18.22 | 29 | 40873 | 222352 | 110326045 |
| Electrocardiogram QT prolonged | 22.89 | 18.22 | 6 | 40896 | 108954 | 110439443 |
| Rhabdomyolysis | 22.81 | 18.22 | 8 | 40894 | 120393 | 110428004 |
| Muscle swelling | 22.56 | 18.22 | 10 | 40892 | 1075 | 110547322 |
| Gastrooesophageal reflux disease | 22.54 | 18.22 | 20 | 40882 | 179956 | 110368441 |
| Hyperkalaemia | 22.54 | 18.22 | 11 | 40891 | 135785 | 110412612 |
| Hyperglycaemia | 22.50 | 18.22 | 76 | 40826 | 85014 | 110463383 |
| Prescribed overdose | 22.27 | 18.22 | 3 | 40899 | 87578 | 110460819 |
| Influenza | 22.15 | 18.22 | 18 | 40884 | 169083 | 110379314 |
| Osteoporosis | 22.12 | 18.22 | 3 | 40899 | 87149 | 110461248 |
| Meningitis bacterial | 22.02 | 18.22 | 14 | 40888 | 3125 | 110545272 |
| Pruritus | 21.81 | 18.22 | 126 | 40776 | 581434 | 109966963 |
| Neurological decompensation | 21.74 | 18.22 | 19 | 40883 | 6864 | 110541533 |
| Exposure during pregnancy | 21.71 | 18.22 | 18 | 40884 | 167406 | 110380991 |
| Radiation interaction | 21.34 | 18.22 | 5 | 40897 | 65 | 110548332 |
| Cognitive disorder | 21.26 | 18.22 | 76 | 40826 | 87435 | 110460962 |
| Chronic obstructive pulmonary disease | 21.12 | 18.22 | 7 | 40895 | 109151 | 110439246 |
| Hepatocellular injury | 20.87 | 18.22 | 53 | 40849 | 50589 | 110497808 |
| Gastroenteropancreatic neuroendocrine tumour disease | 20.68 | 18.22 | 5 | 40897 | 75 | 110548322 |
| Neck pain | 20.40 | 18.22 | 10 | 40892 | 123120 | 110425277 |
| Ascites | 20.37 | 18.22 | 78 | 40824 | 92730 | 110455667 |
| Disorientation | 20.37 | 18.22 | 65 | 40837 | 70606 | 110477791 |
| Swelling of eyelid | 20.28 | 18.22 | 18 | 40884 | 6635 | 110541762 |
| Bronchitis | 20.21 | 18.22 | 17 | 40885 | 157015 | 110391382 |
| Suicidal ideation | 20.06 | 18.22 | 5 | 40897 | 93932 | 110454465 |
| Diffuse large B-cell lymphoma | 20.04 | 18.22 | 27 | 40875 | 15871 | 110532526 |
| Intracranial pressure increased | 19.98 | 18.22 | 22 | 40880 | 10513 | 110537884 |
| Atrial fibrillation | 19.84 | 18.22 | 34 | 40868 | 229608 | 110318789 |
| Encephalomalacia | 19.46 | 18.22 | 10 | 40892 | 1492 | 110546905 |
| Alexia | 19.43 | 18.22 | 4 | 40898 | 27 | 110548370 |
| Monocyte count decreased | 19.42 | 18.22 | 14 | 40888 | 3837 | 110544560 |
| Xanthoma | 19.27 | 18.22 | 6 | 40896 | 238 | 110548159 |
| Anaemia | 19.05 | 18.22 | 296 | 40606 | 546790 | 110001607 |
| Hepatic cytolysis | 19.04 | 18.22 | 54 | 40848 | 54999 | 110493398 |
| Metastases to spinal cord | 19.01 | 18.22 | 6 | 40896 | 249 | 110548148 |
| Acute myocardial infarction | 18.81 | 18.22 | 4 | 40898 | 83773 | 110464624 |
| COVID-19 | 18.78 | 18.22 | 39 | 40863 | 245021 | 110303376 |
| Myxoid liposarcoma | 18.73 | 18.22 | 4 | 40898 | 33 | 110548364 |
| Cerebrospinal fluid leakage | 18.70 | 18.22 | 11 | 40891 | 2137 | 110546260 |
| Breast necrosis | 18.27 | 18.22 | 5 | 40897 | 125 | 110548272 |
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 |
| CHEBI has role | CHEBI:22333 | alkylating agent |
| CHEBI has role | CHEBI:22587 | antiviral agent |
| CHEBI has role | CHEBI:35610 | antineoplastic agent |
| CHEBI has role | CHEBI:50266 | prodrug |
Related Drugs by ATC class:
L01AX Other alkylating agents 3 drugs
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 |
| 7301 | IUPHAR_LIGAND_ID |
| 6027 | INN_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 | 34 sections |
| TEMODAR | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0085-1366 | CAPSULE | 100 mg | ORAL | NDA | 34 sections |
| TEMODAR | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0085-1381 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 2.50 mg | INTRAVENOUS | NDA | 34 sections |
| TEMODAR | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0085-1381 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 2.50 mg | INTRAVENOUS | NDA | 34 sections |
| TEMODAR | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0085-1417 | CAPSULE | 250 mg | ORAL | NDA | 34 sections |
| TEMODAR | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0085-1417 | CAPSULE | 250 mg | ORAL | NDA | 34 sections |
| TEMODAR | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0085-1425 | CAPSULE | 140 mg | ORAL | NDA | 34 sections |
| TEMODAR | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0085-1425 | CAPSULE | 140 mg | ORAL | NDA | 34 sections |
| TEMODAR | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0085-1430 | CAPSULE | 180 mg | ORAL | NDA | 34 sections |
| TEMODAR | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0085-1430 | CAPSULE | 180 mg | ORAL | NDA | 34 sections |
| TEMODAR | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0085-1519 | CAPSULE | 20 mg | ORAL | NDA | 34 sections |
| TEMODAR | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0085-1519 | CAPSULE | 20 mg | ORAL | NDA | 34 sections |
| TEMODAR | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0085-3004 | CAPSULE | 5 mg | ORAL | NDA | 34 sections |
| TEMODAR | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0085-3004 | CAPSULE | 5 mg | ORAL | NDA | 34 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 | 16571-816 | CAPSULE | 5 mg | ORAL | ANDA | 27 sections |
| TEMOZOLOMIDE | Human Prescription Drug Label | 1 | 16571-817 | CAPSULE | 20 mg | ORAL | ANDA | 27 sections |
| TEMOZOLOMIDE | Human Prescription Drug Label | 1 | 16571-818 | CAPSULE | 100 mg | ORAL | ANDA | 27 sections |
| TEMOZOLOMIDE | Human Prescription Drug Label | 1 | 16571-819 | CAPSULE | 140 mg | ORAL | ANDA | 27 sections |
| TEMOZOLOMIDE | Human Prescription Drug Label | 1 | 16571-820 | CAPSULE | 180 mg | ORAL | ANDA | 27 sections |
| TEMOZOLOMIDE | Human Prescription Drug Label | 1 | 16571-821 | CAPSULE | 250 mg | ORAL | ANDA | 27 sections |
| Temozolomide | HUMAN PRESCRIPTION DRUG LABEL | 1 | 16729-048 | CAPSULE | 5 mg | ORAL | ANDA | 30 sections |
| Temozolomide | HUMAN PRESCRIPTION DRUG LABEL | 1 | 16729-049 | CAPSULE | 20 mg | ORAL | ANDA | 30 sections |
| Temozolomide | HUMAN PRESCRIPTION DRUG LABEL | 1 | 16729-050 | CAPSULE | 100 mg | ORAL | ANDA | 30 sections |
| Temozolomide | HUMAN PRESCRIPTION DRUG LABEL | 1 | 16729-051 | CAPSULE | 250 mg | ORAL | ANDA | 30 sections |