Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Temozolomide
Drug ID BADD_D02150
Description Refractory anaplastic astrocytoma (WHO grade III) and Glioblastoma multiforme (WHO grade IV) are primary malignant brain tumours with poor prognosis and limited treatment options. Despite considerable genetic heterogeneity, these tumours often have impaired DNA repair systems, rendering them initially sensitive to alkylating agents, although they invariably develop resistance to these agents over time.[A229848, A229858, L32033] Temozolomide is an imidazotetrazine prodrug that is stable at acidic pH but undergoes spontaneous nonenzymatic hydrolysis at neutral or slightly basic pH; these properties allow for both oral and intravenous administration.[A229853, A229888, A229923, L32033] Following initial hydrolysis, further reactions liberate a highly reactive methyl diazonium cation capable of methylating various residues on adenosine and guanine bases leading to DNA lesions and eventual apoptosis.[A229853, A229923] Temozomolide as an adjunct to radiotherapy followed by maintenance dosing remains the standard of care for both Glioblastoma and refractory anaplastic astrocytoma.[L32033] Temozolomide was granted FDA approval on August 11, 1999, as an oral capsule and subsequently on February 27, 2009, as an intravenous injection. It is currently marketed under the trademark TEMODAR® by Merck.[L32033]
Indications and Usage Temozolomide is indicated in adult patients for the treatment of newly diagnosed glioblastoma concomitantly with radiotherapy and for use as maintenance treatment thereafter. It is also indicated for the treatment of refractory anaplastic astrocytoma in adult patients who have experienced disease progression on a drug regimen containing nitrosourea and procarbazine.[L32033]
Marketing Status approved; investigational
ATC Code L01AX03
DrugBank ID DB00853
KEGG ID D06067
MeSH ID D000077204
PubChem ID 5394
TTD Drug ID D0C8EU
NDC Product Code 75834-143; 29902-0009; 68554-0048; 16729-050; 16729-129; 23155-774; 47335-890; 70771-1092; 75834-142; 16571-818; 0085-1366; 23155-779; 47335-893; 47335-929; 65162-802; 67877-539; 70771-1093; 16571-816; 0085-3004; 16729-049; 47335-930; 50268-761; 64980-337; 65162-806; 68382-754; 70771-1096; 64980-335; 64980-338; 65162-801; 65162-805; 67877-540; 67877-542; 68382-755; 70771-1097; 75834-144; 46014-1450; 0085-1519; 75834-146; 58175-0411; 16571-820; 0085-1425; 0085-1430; 23155-777; 47335-891; 64980-336; 67877-538; 68382-752; 70771-1094; 75834-132; 16571-821; 16729-130; 67877-541; 68382-753; 68382-756; 75834-145; 46014-1121; 50683-0485; 53104-7697; 16729-051; 50268-762; 64980-333; 65162-804; 67877-537; 68382-751; 70771-1095; 14778-1414; 66499-0015; 0085-1417; 23155-778; 64980-334; 81955-0014; 82920-703; 16571-817; 16571-819; 16729-048; 23155-775; 23155-776; 65162-803; 50683-0185; 0085-1381; 47335-892
UNII YF1K15M17Y
Synonyms Temozolomide | 8-Carbamoyl-3-methylimidazo(5,1-d)-1,2,3,5-tetrazin-4(3H)-one | Methazolastone | Temodal | Temodar | Temozolomide Hexyl Ester | TMZA-HE | CCRG 81045 | CCRG-81045 | CCRG81045 | TMZ-Bioshuttle | TMZ Bioshuttle | NSC 362856 | NSC-362856 | NSC362856 | M&B 39831 | M&B-39831 | M&B39831
Chemical Information
Molecular Formula C6H6N6O2
CAS Registry Number 85622-93-1
SMILES CN1C(=O)N2C=NC(=C2N=N1)C(=O)N
Chemical Structure
ADRs Induced by Drug
*The priority for ADR severity classification is based on FAERS assessment, followed by the most severe level in CTCAE rating. If neither is available, it will be displayed as 'Not available'.
**The 'Not Available' level is hidden by default and can be restored by clicking on the legend twice..
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Abdominal distension07.01.04.001--
Abdominal pain07.01.05.002--
Acute hepatic failure09.01.03.0010.000280%Not Available
Acute leukaemia16.01.02.001; 01.10.02.001--Not Available
Acute lymphocytic leukaemia16.01.01.001; 01.10.01.0010.000168%Not Available
Acute myeloid leukaemia16.01.05.001; 01.10.05.0010.000336%Not Available
Acute respiratory distress syndrome24.03.02.034; 10.02.01.067; 22.01.03.0010.000224%
Acute respiratory failure22.02.06.001; 14.01.04.0040.000224%Not Available
Agitation17.02.05.012; 19.06.02.001--
Agranulocytosis01.02.03.0010.000672%Not Available
Alanine aminotransferase increased13.03.04.005--
Alopecia23.02.02.001--
Altered state of consciousness17.02.04.001; 19.07.01.003--Not Available
Alveolitis22.01.01.001--Not Available
Amenorrhoea21.01.02.001; 05.05.01.002--
Amnesia19.20.01.001; 17.03.02.001--
Anaemia01.03.02.0010.001869%
Anaemia megaloblastic14.12.01.003; 01.03.02.0030.000112%Not Available
Anaphylactic reaction10.01.07.001; 24.06.03.006--
Anaphylactic shock24.06.02.004; 10.01.07.002--Not Available
Angioedema22.04.02.008; 23.04.01.001; 10.01.05.009--Not Available
Anxiety19.06.02.002--
Apathy19.04.04.002--Not Available
Aphasia19.21.01.001; 17.02.03.0010.001780%
Aplastic anaemia01.03.03.0020.002350%Not Available
Arthralgia15.01.02.001--
Aspartate aminotransferase increased13.03.04.011--
Asthenia08.01.01.0010.004858%Not Available
Astrocytoma16.30.01.002; 17.20.01.002--Not Available
Ataxia17.02.02.001; 08.01.02.0040.000280%
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