Temozolomide
Other Alkylating Agents
Sold as Kizfizo · Temomedac · TEMODAL · TEMODAR
- Drug class
- Other Alkylating Agents
- Availability
- Prescription only
- Routes
- Oral, Intravenous
- Markets covered
- 4
- Products on record
- 87
- FDA reports (12 mo)
- 1,226
Overview
Plain-language summary, compiled from the cited regulatory records
Temozolomide is an alkylating drug [1]. It belongs to the drug class of Other Alkylating Agents [1].
Temozolomide is approved for treating adults with specific types of brain tumors [1]. This includes newly diagnosed glioblastoma, where it is used concurrently with radiotherapy and then as maintenance treatment [1]. It is also indicated for anaplastic astrocytoma, both as an adjuvant treatment for newly diagnosed cases and for adults with refractory anaplastic astrocytoma [1].
One brand name for temozolomide is TEMODAR [1]. In the past 12 months, there have been 1226 adverse event reports associated with this active ingredient [2]. The most frequent reactions reported include off-label use, product use in an unapproved indication, death, disease progression, and drug ineffectiveness [2].
This is not medical advice. Consult a qualified healthcare professional.
Regulatory status by market
| Market | Regulator | Products | Last revision |
|---|---|---|---|
| GB United Kingdom | MHRA | 48 | May 15, 2026 |
| CA Canada | Health Canada | 33 | March 22, 2025 |
| EU European Union | EMA | 5 | November 6, 2025 |
| US United States | FDA | 1 | February 20, 2026 |
GBUnited Kingdom· MHRA
48 products
Uses
Temozolomide capsules are is indicated for the treatment of: - adult patients with newly-diagnosed glioblastoma multiforme concomitantly with radiotherapy (RT) and subsequently as monotherapy treatment. - children from the age of three years, adolescents and adult patients with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma, showing recurrence or progression after standard therapy.
How to take
CACanada· Health Canada
33 products
Uses
TEMODAL® (temozolomide) is indicated for: treatment of adult patients with newly diagnosed glioblastoma multiforme concomitantly with radiotherapy and then as maintenance treatment. treatment of adult patients with glioblastoma multiforme or anaplastic astrocytoma and documented evidence of recurrence or progression after standard therapy.
1 Pediatrics Pediatrics (<18 years and >3 years): Based on the data submitted and reviewed by Health Canada, the safety and efficacy of TEMODAL® in pediatric patients has not been established; therefore, Health Canada has not authorized an indication for pediatric use.
2 Geriatrics Geriatrics (≥70 years old): Evidence from clinical studies and experience suggests that use in the geriatric population is associated with differences in safety or effectiveness. (see 7 WARNINGS AND PRECAUTIONS)
EUEuropean Union· EMA
5 products
Uses
Temodal is indicated for the treatment of: - adult patients with newly-diagnosed glioblastoma multiforme concomitantly with radiotherapy (RT) and subsequently as monotherapy treatment. - children from the age of three years, adolescents and adult patients with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma, showing recurrence or progression after standard therapy.
How to take
USUnited States· FDA
1 product
Uses
1 INDICATIONS AND USAGE TEMODAR is an alkylating drug indicated for the treatment of adults with: Newly diagnosed glioblastoma concomitantly with radiotherapy and then as maintenance treatment. 1 ) Anaplastic astrocytoma. 2 ) Adjuvant treatment of adults with newly diagnosed anaplastic astrocytoma.
2 ) Treatment of adults with refractory anaplastic astrocytoma. 1 Newly Diagnosed Glioblastoma TEMODAR is indicated for the treatment of adults with newly diagnosed glioblastoma, concomitantly with radiotherapy and then as maintenance treatment.
2 Anaplastic Astrocytoma TEMODAR is indicated for the: adjuvant treatment of adults with newly diagnosed anaplastic astrocytoma; treatment of adults with refractory anaplastic astrocytoma.
Drug interactions
Known interactions involving Temozolomide. Select one for details. This list is informational and not a complete interaction checker.
Showing 240 of 280. Type above to find a specific drug.
Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.
Sources & citations
- [1]MHRA (UK) · PL604770011 · revised July 4, 2025
- [2]Health Canada (DPD) · 02241093 · revised March 22, 2025
- [3]European Medicines Agency · EMEA/H/C/000229 · revised November 6, 2025
- [4]FDA DailyMed · 046a9011-3911-4d… · revised February 20, 2026 [PDF]
- [5]OpenFDA adverse-event reports (US), 12 months ending June 4, 2026.
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.