Temozolomide: uses, dosing, side effects & brands
Temozolomide is an alkylating drug sold in the U.S. under 2 brand and generic names, for glioblastoma and melanoma. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
Key facts
- Drug class
- Alkylating Drug
- Treats (across its forms)
- Glioblastoma and Melanoma
- Available as
- Capsule · Injectable
- Sold as
- 2 products — Temodar and Temozolomide
- Prescription?
- Prescription only
- Generic available?
- Yes
- What the pharmacy pays
- about $149 for a 30-count supply — not your price
How temozolomide is dosed
From the FDA label for Temodar (application NDA021029). Other temozolomide products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
Administer either orally or intravenously. ( 2.4 ) Newly Diagnosed Glioblastoma : 75 mg/m 2 once daily for 42 to 49 days concomitant with focal radiotherapy followed by initial maintenance dose of 150 mg/m 2 once daily for Days 1 to 5 of each 28-day cycle for 6 cycles. May increase maintenance dose to 200 mg/m 2 for Cycles 2 to 6 based on toxicity. ( 2.1 ) Provide Pneumocystis pneumonia (PCP) prophylaxis during concomitant phase and continue in patients who develop lymphopenia until resolution to Grade 1 or less. ( 2.1 ) Adjuvant Treatment of Newly Diagnosed Anaplastic Astrocytoma: Beginning 4 weeks after the end of radiotherapy, administer TEMODAR orally in a single dose on days 1-5 of a 28-day cycle for 12 cycles. The recommended dosage for Cycle 1 is 150 mg/m 2 per day and for Cycles 2 to 12 is 200 mg/m 2 if patient experienced no or minimal toxicity in Cycle 1. ( 2.2 ) Refractory Anaplastic Astrocytoma: Initial dose of 150 mg/m 2 once daily on Days 1 to 5 of each 28-day cycle. ( 2.2 ) 2.1 Monitoring to Inform Dosage and Administration Prior to dosing, withhold TEMODAR until patients have an absolute neutrophil count (ANC) of 1.5 x 10 9 /L or greater and a platelet count of 100 x 10 9 /L or greater. For concomitant radiotherapy, obtain a complete blood count prior to initiation of treatment and weekly during treatment. For the 28-day treatment cycles, obtain a complete…
Temozolomide side effects
The following clinically significant adverse reactions are described elsewhere in the labeling: Myelosuppression [see Warnings and Precautions (5.1) ] Hepatotoxicity [see Warnings and Precautions (5.2) ] Pneumocystis Pneumonia [see Warnings and Precautions (5.3) ] Secondary Malignancies [see Warnings and Precautions (5.4) ] The most common adverse reactions (≥20%) are: alopecia, fatigue, nausea, vomiting, headache, constipation, anorexia, and convulsions. ( 6.1 ) The most common Grade 3 to 4 hematologic laboratory abnormalities (≥10%) in patients with anaplastic astrocytoma are: decreased lymphocytes, decreased platelets, decreased neutrophils, and decreased leukocytes. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Merck Sharp & Dohme LLC at 1-877-888-4231 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Newly Diagnosed Glioblastoma The safety of TEMODAR was evaluated in study MK-7365-051 [see Clinical Studies (14.1) ]. Severe or life-threatening adverse reactions occurred in 49% of patients treated with TEMODAR; the most common were fatigue (13%), convulsions (6%), headache…
Who shouldn’t take temozolomide
TEMODAR is contraindicated in patients with a history of serious hypersensitivity reactions to: temozolomide or any other ingredients in TEMODAR; and dacarbazine, since both temozolomide and dacarbazine are metabolized to the same active metabolite 5-(3-methyltriazen-1-yl)-imidazole-4-carboxamide. Reactions to TEMODAR have included anaphylaxis [see Adverse Reactions (6.2) ]. History of serious hypersensitivity to temozolomide or any other ingredients in TEMODAR and dacarbazine. ( 4 )
Every temozolomide product we track (2)
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
| # | Drug | Rating | Type | Form | Generic? | Pharmacy pays | |
|---|---|---|---|---|---|---|---|
| 1 | 70/100 | Prescription | Capsule | Generic | $149 | View → | |
| 2 | Not yet rated | Prescription | Capsule | Generic | $149 | View → |
What temozolomide pills look like
Imprint codes, colour and shape from the FDA’s labelling data. Match the imprint on your pill — or search any imprint.
Temozolomide recalls
From the FDA Enforcement database. A recall covers specific lots — not the drug as a whole.
Can you crush or split temozolomide?
At least one temozolomideproduct is labelled to be swallowed whole — crushing an extended-release tablet releases the whole day’s dose at once. Which applies depends on the form you were given.
What each temozolomide label says about crushing, splitting and chewingHow long temozolomide keeps
The date on a sealed pack is not the only one: some temozolomide labels start a second clock once the product is opened or mixed, as short as 14 hours.
Does temozolomide expire? The in-use limits and storage rules from its labelsWhat people report to the FDA about temozolomide
The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 17,966 reports naming temozolomide, and the FDA flagged 82% of those reports as serious. The effects reported most often — leaving out reports about overdose, misuse or the condition being treated, which dominate the raw list for common medicines:
- thrombocytopenia1,408 reports
- nausea1,216 reports
- neutropenia924 reports
- fatigue874 reports
- vomiting857 reports
- febrile neutropenia767 reports
- malignant neoplasm progression767 reports
- anaemia679 reports
Read these as a signal, not a rate. A report does not mean temozolomide caused the effect — anyone can file one, and many describe people taking several medicines for several conditions. Crucially there is no denominator: FAERS does not record how many people took the drug, so these counts cannot be turned into “X% of patients” — a bigger number often just means a more widely used or more talked-about drug. Duplicates exist, and publicity drives reporting. For what is actually established, read the FDA label section above.
Source: openFDA drug/event (FAERS), retrieved July 26, 2026.
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Frequently asked questions
What is temozolomide?
Temodar (Temozolomide) is an alkylating drug used to treat Glioblastoma, Melanoma.
What kind of drug is temozolomide?
The FDA classifies temozolomide as an alkylating drug. Alkylating chemotherapy drugs attach chemical groups to a cell's DNA, forming cross-links that lock the two DNA strands together. This damage stops the cell from copying its DNA and dividing, which triggers it to die; because they are not limited to one phase of the cell cycle, they can act on cells whether or not they are actively dividing. If you are checking whether it is safe to combine with something else, the class is what matters — two drugs from the same class usually should not be stacked.
Can you take temozolomide with other medicines?
It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run temozolomide against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
What brand names is temozolomide sold under?
We track 2 temozolomide-containing products in the U.S.: Temodar and Temozolomide. They are the same active ingredient; they differ in form, manufacturer, price and FDA recall record.
What forms does temozolomide come in?
Across the brands we track, temozolomide is currently marketed as capsule and injectable, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.
Is there a generic temozolomide?
Yes. Our catalog lists 1 generic temozolomide product alongside the brand versions. A generic has the same active ingredient and must meet the FDA's bioequivalence standard; it usually costs less. Ask your pharmacist which one your plan covers.
Has temozolomide been recalled?
The FDA's Enforcement database lists 1 recall record whose product description mentions temozolomide. The most recent: Product label: Temozolomide Capsules (Mar 3, 2026). A recall applies to specific lots, not to the drug as a whole — check the record for the affected lot numbers.
Cite this page
- APA
- pharmaranks. (2026, July 24). Temozolomide: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/temozolomide
- MLA
- “Temozolomide: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/temozolomide.
We summarise public FDA and NIH sources — for a clinical claim, cite the primary source we link to as well.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Read the full FDA label for temozolomide on DailyMed (NIH) ↗.