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Temozolomide

Temozolomide is a chemotherapy drug used to treat certain aggressive brain tumors, including newly diagnosed glioblastoma and anaplastic astrocytoma, in adults.

Brand name Temodar
Drug class Alkylating Drug
Rx Forms 2
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026 Content updated Oct 2, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 20 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

✓No current FDA shortage listed · checked Oct 8, 2026 🚨Recall on record
Other forms & routes:
Injection
Temozolomide at a glance The quick version — the full detail is in the Patient Information Guide below.
Dr. Brian Staiger, PharmD, BCPS
The Pharmacist’s Take By · Clinical pharmacist · Written

Temozolomide (Temodar) is a chemotherapy drug for aggressive brain tumors in adults, mainly glioblastoma and anaplastic astrocytoma, that kills cancer cells by damaging their DNA; it is the standard partner to radiation for glioblastoma, on the market since about 1999 and available as a generic. For chemotherapy it is usually manageable, and nausea, tiredness and constipation are what most people notice. Its boxed warning targets dosing mix-ups, since each capsule strength must come in its own labeled container, so check the strength and count every cycle. The bigger medical risk is a serious drop in blood counts (myelosuppression), plus possible liver injury, which is why blood tests are frequent.

Clinical pearls

  • Swallow the capsules whole with water on an empty stomach, and never open, chew or dissolve them.
  • If a capsule breaks, avoid touching the powder and rinse any skin or eyes it reaches with water right away.
  • Steroids like dexamethasone raise the risk of Pneumocystis, a serious lung infection, so report new cough or breathlessness quickly.
  • Use effective contraception until 6 months after the last dose for women, 3 months (condoms, no semen donation) for men.
How we write & review this content — our editorial policy →
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾

Every container of temozolomide capsules must clearly show the strength of each capsule, and patients must take the correct number of capsules from each package. Temozolomide comes in multiple capsule strengths. Taking the wrong number of capsules — or getting the wrong strength — could result in a serious overdose or underdose. When your pharmacist dispenses temozolomide, each strength must be packaged separately in its own vial or original package, labeled with the strength per capsule. Always double-check the strength and number of capsules with your pharmacist before each treatment cycle.

Read the full warning on DailyMed →
How you get itPrescription only
Comes asCapsule, Injection
Earliest FDA record1999
Companies listing it with the FDA12
FDA label last updatedFeb 20, 2026
FDA’s strongest warning (boxed)Yes, read the warning

Patient information guide A plain-language walkthrough of Temozolomide, written from its FDA label.

What Temozolomide is used for

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Temozolomide is a chemotherapy drug approved for the treatment of certain malignant brain tumors in adults. The specific indications depend on the product and formulation:

  • Newly diagnosed glioblastoma — both Temodar (capsule and injection) and Temozolomide Capsules, USP are indicated for adults, given alongside focal radiation therapy and then continued as maintenance treatment
  • Adjuvant treatment of newly diagnosed anaplastic astrocytoma — Temodar (capsule and injection) is indicated for adults, beginning after completion of radiotherapy
  • Refractory anaplastic astrocytoma — Temodar (capsule and injection) is indicated for adults with this condition; Temozolomide Capsules, USP are specifically indicated for adults whose disease has progressed on a regimen containing nitrosourea and procarbazine

How Temozolomide works

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Temozolomide is not active in its original form. Once it enters the body, it spontaneously converts — without needing liver enzymes — into a reactive compound that directly attacks DNA in cancer cells. This process (called DNA alkylation) damages the genetic material at specific sites, causes DNA strands to break, and triggers cancer cells to undergo programmed cell death. Normal liver enzymes play only a minor supporting role.

Temozolomide dosage

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Temozolomide is taken once daily, either as a capsule by mouth or as an intravenous infusion over 90 minutes, depending on the product and treatment phase. Treatment generally follows one of two phases: a concomitant phase (given every day alongside radiation for several consecutive weeks) and a maintenance or adjuvant phase (given only on the first 5 days of a repeating 28-day cycle).

  • Capsules should be swallowed whole with a full glass of water; high-fat meals can reduce and delay absorption, so consistent timing relative to food matters
  • Blood counts must be checked regularly before and during treatment — your doctor may pause or adjust treatment based on those results
  • Always follow your prescriber's specific schedule and never adjust doses on your own

Dosing details from the FDA-approved label

From the Temozolomide prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.

  • Newly Diagnosed Glioblastoma - Concomitant Phase
    • 75 mg/m2 either orally or intravenously once daily for 42 to 49 days in combination with focal radiotherapy
    • Provide PCP prophylaxis during the concomitant phase and continue in patients who develop lymphopenia until resolution to Grade 1 or less
  • Newly Diagnosed Glioblastoma - Single Agent Maintenance Phase
    • Beginning 4 weeks after concomitant phase completion, once daily on Days 1 to 5 of each 28-day cycle for 6 cycles
    • Cycle 1: 150 mg/m2 per day on days 1 to 5
    • Cycles 2 to 6: may increase to 200 mg/m2 per day on days 1 to 5 before starting Cycle 2 if no dosage interruptions or discontinuations are required
    • Maximum: 200 mg/m2 per day
    • If dose is not escalated at the onset of Cycle 2, do not increase for Cycles 3 to 6; if withheld, reduce next cycle dose by 50 mg/m2 per day
  • Adjuvant Treatment of Newly Diagnosed Anaplastic Astrocytoma
    • Beginning 4 weeks after the end of radiotherapy, orally in a single dose on days 1 to 5 of a 28-day cycle for 12 cycles
    • Cycle 1: 150 mg/m2 per day
    • Cycles 2 to 12: 200 mg/m2 per day if no or minimal toxicity in Cycle 1
    • Maximum: 200 mg/m2 per day
    • If dose was not escalated at the onset of Cycle 2, do not increase the dose during Cycles 3 to 6
  • Refractory Anaplastic Astrocytoma
    • Initial dose of 150 mg/m2 once daily on Days 1 to 5 of each 28-day cycle
    • Increase to 200 mg/m2 per day if ANC is greater than or equal to 1.5 × 10^9/L and platelet count is greater than or equal to 100 × 10^9/L at the nadir and on Day 1 of the next cycle
    • Continue until disease progression or unacceptable toxicity
    • Maximum: 200 mg/m2 per day
Read the label’s full dosing text

2 DOSAGE AND ADMINISTRATION 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 blood count prior to treatment on Day 1 and on Day 22 of each cycle. Perform complete blood counts weekly until recovery if the ANC falls below 1.5 x 10 9 /L and the platelet count falls below 100 x 10 9 /L. For concomitant use with focal radiotherapy, obtain a complete blood count weekly and as clinically indicated. 2.2 Recommended Dosage and Dosage Modifications for Newly Diagnosed Glioblastoma Administer TEMODAR either orally or intravenously once daily for 42 to 49 consecutive days during the concomitant use phase with focal radiotherapy, and then once daily on Days 1 to 5 of each 28-day cycle for 6 cycles during the maintenance use phase. Provide Pneumocystis pneumonia (PCP) prophylaxis during the concomitant use phase and continue in patients who develop lymphopenia until resolution to Grade 1 or less [see Warnings and Precautions (5.3) ] .

Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →

Temozolomide side effects

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The most common side effects with temozolomide include:

Common side effects

  • Hair loss (alopecia)
  • Nausea and vomiting
  • Fatigue
  • Headache
  • Constipation
  • Loss of appetite (anorexia)
  • Seizures (convulsions)
  • Rash
  • Rash and dry skin

When to get medical help

  • Call your doctor right away if you develop unusual bruising, bleeding, or signs of infection (fever, chills) — these may signal dangerously low blood counts (myelosuppression)
  • Seek immediate help for shortness of breath or signs of a serious lung infection such as Pneumocystis pneumonia (PCP), especially if you are on steroids
  • Report yellowing of the skin or eyes, dark urine, or severe stomach pain — these can be signs of serious liver injury (hepatotoxicity)
  • Tell your care team immediately if you experience new or worsening neurological symptoms — secondary cancers including leukemia have been reported with temozolomide treatment
  • If a capsule is damaged and the powder contacts your skin or eyes, wash the area immediately with water and contact your care team

Serious reactions to watch for include dangerously low blood counts (which can cause infection, bleeding, or anemia), severe liver injury, a serious lung infection called Pneumocystis pneumonia, and — rarely — secondary cancers such as leukemia. Contact your care team immediately if you develop fever, unusual bleeding, yellowing of the skin or eyes, or breathing problems.

Temozolomide warnings and precautions

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  • Low blood counts (myelosuppression): Temozolomide can seriously suppress the bone marrow, reducing white blood cells, platelets, and red blood cells. This can lead to life-threatening infections or bleeding. Women and older adults face a higher risk. Blood counts are monitored closely throughout treatment.
  • Liver damage (hepatotoxicity): Severe and fatal liver injury has been reported. Liver function tests are done at the start of treatment, throughout each cycle, and after completing treatment.
  • Pneumocystis pneumonia (PCP): A serious lung infection that can develop, especially in patients receiving steroids or on longer treatment courses. Preventive treatment may be prescribed, and all patients are monitored for this.
  • Secondary cancers: Cases of myelodysplastic syndrome and secondary leukemia have been observed after treatment with temozolomide-containing regimens.
  • Fetal harm: Temozolomide can cause severe birth defects or pregnancy loss. Effective contraception is required during treatment and for months afterward in both women and men.
  • Capsule safety: Never open, chew, or dissolve temozolomide capsules. If a capsule is damaged, avoid contact with the powder and wash any exposed area immediately.

Temozolomide interactions

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The number of significant drug interactions with temozolomide is relatively limited, but your care team should know about all your medications:

  • Valproic acid (used for seizures or mood disorders) — may slightly decrease the clearance of temozolomide, meaning more drug stays in the body; your team will monitor you closely
  • Dexamethasone, phenytoin, carbamazepine, phenobarbital, prochlorperazine, ondansetron, ranitidine, and other histamine-2 blockers — studies showed these did not meaningfully change how the body processes temozolomide, but always report every medication, supplement, and herbal product you take

Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.

🌿25 supplements and herbs with documented Temozolomide interactions, ranked by severity Check Temozolomide against a supplement or herb →

Before taking Temozolomide

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  • Do not take temozolomide if you have ever had a serious allergic reaction (including anaphylaxis) to temozolomide, dacarbazine, or any ingredient in the formulation — this is a contraindication
  • Tell your doctor if you are pregnant; temozolomide can cause serious fetal harm including malformations and pregnancy loss
  • Women who could become pregnant must have a pregnancy test before starting and must use effective contraception during treatment and for 6 months after the last dose
  • Men with pregnant partners or partners who could become pregnant must use condoms during treatment and for 3 months after the last dose, and must not donate semen during this time; temozolomide may affect male fertility
  • Do not breastfeed while taking temozolomide or for 1 week after the last dose — serious harm to a nursing infant is possible
  • Older adults (especially over age 65–70) and women are at higher risk for severe low blood counts and need closer monitoring
  • Safety and effectiveness have not been established in children
  • If you have severe kidney impairment (creatinine clearance below 36 mL/min) or end-stage kidney disease on dialysis, the appropriate dose is not established — discuss with your doctor
  • If you have severe liver impairment (Child-Pugh class C), the appropriate dose is not established — discuss with your doctor

Temozolomide overdose

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Taking too much temozolomide causes severe suppression of the bone marrow (myelosuppression), and at very high doses, can result in pancytopenia (dangerously low counts of all blood cell types), fever, multi-organ failure, and death. If an overdose is suspected, seek emergency medical help immediately. Treatment involves close monitoring of blood counts and supportive care.

What Temozolomide does in the body

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Temozolomide works by damaging the DNA of cancer cells, which triggers those cells to undergo programmed cell death. The precise relationship between how much drug is in the body and the magnitude of its effect — and how quickly those effects develop over time — has not been fully characterized.

How your body processes Temozolomide

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After an oral dose, temozolomide is absorbed quickly, reaching peak blood levels in about 1 hour; a high-fat meal significantly slows and slightly reduces this absorption, so consistent dosing conditions matter. The drug has a short half-life of roughly 1.8 hours and is spontaneously converted in the body (not primarily by liver enzymes) into its active form. About 38% of a dose is recovered in the urine over 7 days, mostly as unchanged drug and breakdown products. The body handles temozolomide similarly regardless of age (19–78 years), sex, smoking status, or mild-to-moderate kidney or liver impairment; however, its behavior in patients with severe kidney or liver disease has not been well studied.

How to store Temozolomide

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Store TEMODAR Capsules at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) . Store TEMODAR for injection refrigerated at 2°C to 8°C (36°F to 46°F).

Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

25

Supplements & herbs that interact with Temozolomide

25 supplements and herbal products have documented interactions with Temozolomide in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.

Severity mix
  • Major · 1
  • Moderate · 14
  • Minor · 10
ACTIVATED CHARCOAL Major ACEROLA Moderate ALPHA-LIPOIC ACID Moderate COENZYME Q10 Moderate COFFEE CHARCOAL Moderate EUROPEAN MANDRAKE Moderate GLUCOMANNAN Moderate GUAR GUM Moderate +17 more
Every supplement checked against Temozolomide — ranked by severity The full interaction hub: 1 major · 14 moderate · 10 minor · every one linked to its full report. Check Temozolomide against your exact supplements

Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.

1

Nutrient depletion considerations

Temozolomide has been associated with lower levels of 1 nutrient in the clinical literature. This does not mean a deficiency will occur — it means these may be worth discussing with your pharmacist or healthcare provider, especially with long-term use.

VITAMIN E Insufficient Evidence
See the full Temozolomide nutrient depletion report

Educational information from a licensed clinical database (Natural Medicines) — not medical advice. Do not start or stop medications or supplements without professional guidance.

Temozolomide: pharmacist answers to common questions

Quick, plain-English answers to the questions patients ask most about Temozolomide — the kind of thing our pharmacy team would talk through with you at the counter.

What exactly is temozolomide treating, and why do I need it?

▾
Temozolomide is a chemotherapy used to treat aggressive brain tumors — specifically glioblastoma (a fast-growing brain tumor) and anaplastic astrocytoma. It works by getting into cancer cells and damaging their DNA so they can no longer divide and grow. Depending on your diagnosis, your doctor may combine it with radiation or use it on its own. Your specific treatment plan will depend on which tumor you have and how your body responds.

How should I take the capsules — does it matter when I take them or whether I eat first?

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Yes, it does matter. Swallow the capsules whole with a full glass of water — never open, crush, or chew them. Try to avoid taking them right after a high-fat meal, because fat can slow absorption and reduce how much of the drug gets into your system. Your doctor or pharmacist can guide you on the best timing. If you accidentally open or damage a capsule, avoid touching the powder and wash any exposed skin right away with water.

What side effects should I expect, and which ones mean I need to call my doctor?

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The most common side effects are nausea, vomiting, fatigue, headache, hair loss, constipation, and poor appetite — these are expected and your team can help manage them. The ones to call about right away are fever, chills, unusual bruising or bleeding (signs your blood counts may be dangerously low), or shortness of breath (which could signal a serious lung infection). Yellowing of the skin or eyes, dark urine, or severe stomach pain could mean liver problems and also need immediate attention.

Why do I need so many blood tests while I'm on this medication?

▾
Temozolomide can lower your white blood cells, red blood cells, and platelets — a condition called myelosuppression. These drops can happen without obvious symptoms at first, but they make you vulnerable to serious infections and bleeding. Regular blood tests let your team catch problems early and pause or adjust your dose before anything becomes life-threatening. Women and older adults are especially at risk, so monitoring is even more important for those patients.

Is it safe to get pregnant or father a child while on this treatment?

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No — temozolomide can seriously harm a developing baby, including causing birth defects or pregnancy loss. If you could become pregnant, you need to use effective contraception throughout treatment and for 6 months after your last dose. If you're a man, you need to use condoms during treatment and for 3 months after your last dose, and avoid donating sperm during that time. There is also some evidence the drug can affect sperm. If pregnancy is a concern, talk to your doctor before starting treatment.

Can I breastfeed while taking temozolomide?

▾
No. It is not safe to breastfeed while on temozolomide or for at least 1 week after your last dose. The drug could pass into breast milk and cause serious harm — including bone marrow suppression — in a nursing baby. Talk to your care team about your options for feeding your baby during and just after treatment.

Is Temozolomide available over the counter?

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No. Temozolomide is a prescription medicine: every Temozolomide product listed with the FDA is prescription only, so it is not sold over the counter. Your prescriber decides whether it is appropriate for you, and your pharmacist dispenses it.

When was Temozolomide first available?

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The earliest FDA record we hold for Temozolomide is from 1999: its first approval in Drugs@FDA or its earliest product listing in the NDC Directory, whichever is older. Many older medicines were in use before their first formal FDA approval, so this is the earliest date on record, not necessarily when Temozolomide was first used.

Who makes Temozolomide?

▾
12 companies currently list Temozolomide products in the FDA's NDC Directory, including Merck Sharp & Dohme LLC, Accord Healthcare Inc., Amneal Pharmaceuticals LLC. That count includes repackagers and distributors as well as manufacturers (companies that sell only the raw ingredient are not counted), so fewer companies actually make it; the label on your bottle names the one that supplied yours.

Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

More about Temozolomide on HelloPharmacist

📊Temozolomide supplement interactions25 checked — ranked by severity 🌿Drug & Supplement CheckerTemozolomide vs. vitamins & herbs 💬Ask a PharmacistFree answer, usually < 24h 🔎NDC & pricing lookupFind Temozolomide NDCs & costs 🅰️Browse Drugs A–ZLook up any medication
Detailed data & references for Temozolomide Forms & strengths, pricing, billing codes, manufacturers, safety reports and sourcing — the data behind the page. Most people can stop here. Each section below opens on a tap.

Temozolomide forms and strengths (how it comes)

Temozolomide is available in 2 forms. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Need a version that does not list lactose, a gluten source, a dye or gelatin? Inactive ingredients differ by manufacturer: see Temozolomide inactive ingredients by manufacturer.

Capsule

By mouth
Brands Temodar
How this form is used
What it may be used for
  • Temodar capsules are used for newly diagnosed glioblastoma alongside radiation and then as maintenance treatment in adults
  • Temodar capsules are used for adjuvant treatment of newly diagnosed anaplastic astrocytoma and for refractory anaplastic astrocytoma in adults
  • Temozolomide Capsules, USP are used for newly diagnosed glioblastoma alongside radiation and then as maintenance treatment in adults
  • Temozolomide Capsules, USP are used for refractory anaplastic astrocytoma in adults whose disease progressed after nitrosourea- and procarbazine-containing treatment
Important instructions
  • Swallow capsules whole with a full glass of water — do not open, chew, or dissolve them
  • Taking Temozolomide Capsules on an empty stomach (avoiding high-fat meals) leads to more consistent absorption
  • If a capsule is damaged, avoid contact with the powder — wash any exposed skin or mucous membranes immediately with water
  • Follow your prescriber's exact schedule; capsules are taken once daily either every day during the radiation phase or on set days within a 28-day cycle
Available strengths 6 strengths
5 mg 20 mg 100 mg 140 mg 180 mg 250 mg
152 FDA-listed product records ⓘ

Injection

By injection · Into a vein
Brands Temodar
How this form is used
What it may be used for
  • Temodar injection is used for newly diagnosed glioblastoma alongside radiation and then as maintenance treatment in adults
  • Temodar injection is used for adjuvant treatment of newly diagnosed anaplastic astrocytoma and for refractory anaplastic astrocytoma in adults
Important instructions
  • Temodar injection is given as an intravenous infusion (into a vein) over 90 minutes
  • Temodar injection is given once daily, either during the concomitant radiation phase or on specific days within a 28-day cycle, following your prescriber's schedule
Available strengths 1 strength
2.5 mg/mL
4 FDA-listed product records ⓘ

Temozolomide on the U.S. market: products, makers and brands

How Temozolomide appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

12 companies list 71 Temozolomide product records with the FDA, mostly as capsule, injection; the earliest marketing or approval year on record is 1999. Brand names on the directory include Temodar; the rest are generics.

2
Dose forms ⓘ
12
Labelers (makers, repackagers, distributors)
2
Brand names
71
FDA-listed product records ⓘ
1999
Earliest FDA record ⓘ

FDA-listed product records by dose form (tablet variants merged) — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

Also listed with the FDA, not a patient dose form: Powder (15) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

Merck Sharp & Dohme LLC10%
Accord Healthcare Inc.8%
Amneal Pharmaceuticals LLC8%
Ascend Laboratories, LLC8%
Bryant Ranch Prepack8%
Camber Pharmaceuticals, Inc.8%
Other makers48%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

How widely Temozolomide is used (Medicaid data)

A general measure of how commonly Temozolomide is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Temozolomide is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

4,846
Medicaid prescriptions filled (Q1–Q4 2025)
$1.6M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Temozolomide prescribed? Of the 1,601 medications we measure, Temozolomide ranks #1,052 by Medicaid prescriptions — more than 34% of them.

Where Temozolomide ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5
Total prescriptions — #1,052 of 1,601
#1,047 Avacincaptad Pegol 4,978 Rx #1,048 Acalabrutinib 4,921 Rx #1,049 Ciprofloxacin Injectio... 4,872 Rx #1,050 Lanreotide Injection 4,864 Rx #1,051 Alcohol 4,861 Rx #1,052 Temozolomide 4,846 Rx #1,053 Hydralazine / Isosorbi... 4,770 Rx #1,054 Teduglutide Injection 4,744 Rx #1,055 Rifapentine 4,737 Rx #1,056 Dronabinol 4,723 Rx #1,057 Trofinetide 4,625 Rx

Utilization by Temozolomide product

Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

The 100 mg oral capsule is the most-dispensed Temozolomide product — about 37% of these Medicaid prescriptions.

temozolomide 100 MG Oral Capsule Most dispensed

1,810 Medicaid prescriptions (Q1–Q4 2025) 37% of Temozolomide prescriptions shown $524,538 gross reimbursement (before rebates) ≈ $290 per prescription (gross)

Summed across the 9 of 49 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 317160

temozolomide 140 MG Oral Capsule

818 Medicaid prescriptions (Q1–Q4 2025) 17% of Temozolomide prescriptions shown $280,534 gross reimbursement (before rebates) ≈ $343 per prescription (gross)

Summed across the 8 of 54 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 700883

temozolomide 250 MG Oral Capsule

543 Medicaid prescriptions (Q1–Q4 2025) 11% of Temozolomide prescriptions shown $165,405 gross reimbursement (before rebates) ≈ $305 per prescription (gross)

Summed across the 4 of 35 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 313210

temozolomide 5 MG Oral Capsule

459 Medicaid prescriptions (Q1–Q4 2025) 9% of Temozolomide prescriptions shown $25,244 gross reimbursement (before rebates) ≈ $55 per prescription (gross)

Summed across the 7 of 55 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 313211

temozolomide 20 MG Oral Capsule

453 Medicaid prescriptions (Q1–Q4 2025) 9% of Temozolomide prescriptions shown $40,728 gross reimbursement (before rebates) ≈ $90 per prescription (gross)

Summed across the 11 of 57 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 313209

temozolomide 180 MG Oral Capsule

433 Medicaid prescriptions (Q1–Q4 2025) 9% of Temozolomide prescriptions shown $158,320 gross reimbursement (before rebates) ≈ $366 per prescription (gross)

Summed across the 7 of 53 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 700885

temozolomide 100 MG Injection

330 Medicaid prescriptions (Q1–Q4 2025) 7% of Temozolomide prescriptions shown $449,499 gross reimbursement (before rebates) ≈ $1,362 per prescription (gross)

Summed across the 1 of 1 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 835945

Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Temozolomide, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 47 of 304 listed Temozolomide NDCs with Medicaid activity.

Compare Temozolomide products

A representative set of FDA-listed product records for Temozolomide — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Showing 71 of 71 products — FDA National Drug Code Directory. See every product, package size and price: browse all 71 Temozolomide NDCs →

Temozolomide recall history

A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.

The FDA’s enforcement reports list one Temozolomide recall since July 2021. It is still ongoing. A recall names specific lots from one company, so check the lot number on your own bottle rather than assuming every product is affected; your pharmacist can check whether your supply came from an affected lot.

Ongoing Class II Mar 3, 2026 · Rising Pharma Holding, Inc.
Failed Impurities/Degradation Specifications: An out-of-specification result observed during 9th-month long term stability testing
  • Product label: Temozolomide Capsules, 5mg, packaged in 5-capsule bottles, Rx only, Manufactured for: Rising Pharmaceuticals, Inc., Allendale, NJ 07401, Country of origin: Taiwan, NDC 16571-816-51. Lots: Lot #: 1TM0524003A, Exp. Date 09/2026. FDA record D-0384-2026 →

Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

Ingredient (IN) Temozolomide RxCUI 37776 2 dose forms · 7 strengths
  1. Dose form (SCDF) Injection RxCUI 1724292 In current FDA listings
    Clinical drug / strength (SCD) 100 MG RxCUI 835945
  2. Dose form (SCDF) Oral Capsule RxCUI 374610 In current FDA listings
    Clinical drug / strength (SCD) 5 MG RxCUI 313211 20 MG RxCUI 313209 100 MG RxCUI 317160 140 MG RxCUI 700883 180 MG RxCUI 700885 250 MG RxCUI 313210

Look up RxCUI 37776 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

Temozolomide brand names

Temozolomide is sold under one brand name in the FDA directory — Temodar. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.

Temodar

Who makes Temozolomide: manufacturers and labelers

12 companies list Temozolomide products with the FDA. By number of product records, the largest are Merck Sharp & Dohme LLC, Accord Healthcare Inc., Amneal Pharmaceuticals LLC. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.

Merck Sharp & Dohme LLC 7 Accord Healthcare Inc. 6 Amneal Pharmaceuticals LLC 6 Ascend Laboratories, LLC 6 Bryant Ranch Prepack 6 Camber Pharmaceuticals, Inc. 6 CivicaScript LLC 6 Devatis, Inc. 6 Nivagen Pharmaceuticals, Inc. 6 Rising Pharma Holdings, Inc. 6 Sun Pharmaceutical Industries, Inc. 6 OPKO Pharmaceuticals, LLC 4

Temozolomide drug class (RxNorm)

Temozolomide belongs to the Alkylating Drug class.

Pharmacologic class Alkylating Drug
Drug family (ATC) Other alkylating agents
How it works Alkylating Activity

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

Sources for this Temozolomide page

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Feb 20, 2026
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Temozolomide.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Temozolomide after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
20
Finished products in the current FDA directory
71
Companies listing them (makers, repackagers, distributors)
12
FDA labeler codes behind them ⓘ
12
Linked representative label ⓘ
Merck Sharp & Dohme LLC
Linked label effective
Feb 20, 2026
Composite sections available
24
Linked SPL Set ID
046a9011-3911-4d3f-a15f-fbb56d5aad56
Linked SPL Document ID
40ceddc0-83a2-4b3b-8953-fd0078a41133
Open the linked representative label on DailyMed ↗

How this page is built

HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Merck Sharp & Dohme LLC is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →