FDA-filed SPL labeling · retrieved through openFDA

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 Routes Oral · Intravenous
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 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 →

At a glance
Linked label effectiveFeb 20, 2026
Clinical labels in scope ⓘ20
AvailabilityRx
Earliest approval/marketing year ⓘ1999
FDA-listed product records ⓘ228
Boxed warningYes
How we combine label and product data →
✓No current FDA shortage listed · checked Sep 22, 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.
💊
HelloPharmacist Editorial Team Bottom Line
Temozolomide is a powerful chemotherapy used to treat aggressive brain tumors — glioblastoma and anaplastic astrocytoma — in adults, often alongside radiation therapy. It requires close blood count and liver monitoring throughout treatment because it can cause serious drops in blood cell levels and, rarely, liver damage. Follow your prescriber's instructions exactly, swallow capsules whole, and never miss a monitoring appointment.
How we write & review this content — our editorial policy →
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾

Important dispensing warning: Temozolomide capsules come in different strengths. To avoid dangerous dosing errors, each container must clearly state the strength of each capsule. Patients should always check that they are taking the right number of capsules from the right package. If you have any doubt about your dose or packaging, contact your pharmacist before taking the medication.

Read the full warning on DailyMed →

📖 Temozolomide: Patient Information Guide

A plain-language walkthrough of Temozolomide — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.

🎯What it's used for▾

Temozolomide is an alkylating chemotherapy drug approved for adults with certain aggressive brain tumors. Specific approvals depend on the product:

  • Newly diagnosed glioblastoma: Both Temodar (oral/IV) and Temozolomide Capsules, USP are approved for use alongside radiation therapy, followed by maintenance treatment.
  • Adjuvant treatment of newly diagnosed anaplastic astrocytoma: Temodar (oral/IV) is approved for this use, starting about 4 weeks after completing radiation.
  • Refractory anaplastic astrocytoma (tumor not responding to prior treatment): Temodar (oral/IV) is approved for adults whose disease has returned or progressed. Temozolomide Capsules, USP are specifically approved for patients whose disease has progressed on a prior regimen containing nitrosourea and procarbazine.
⚙️How it works▾

Temozolomide doesn't attack cancer cells directly. Instead, once it enters the body, it spontaneously converts to an active compound called MTIC. MTIC works by attaching chemical groups to DNA — specifically at key spots on a building block called guanine — causing DNA strands to break. Cancer cells cannot repair this damage and undergo programmed cell death (apoptosis). Because it crosses into the brain readily, it is particularly well-suited to treating brain tumors.

💊How it's taken▾

Temozolomide can be given by mouth (capsule) or as an intravenous infusion, depending on the product and treatment phase. During the phase when it is given alongside radiation, it is taken once daily for several weeks straight. During maintenance cycles, it is taken once daily on only the first 5 days of a 28-day cycle. Food can reduce how quickly the drug is absorbed, so ask your prescriber whether to take it with or without food and stay consistent.

  • Always swallow capsules whole — never open, crush, or chew them
  • Blood counts must be checked before each cycle and regularly during treatment to guide dosing decisions
  • Your prescriber may adjust or pause your dose based on how your blood counts and other lab values respond
🤒Side effects — in detail▾

The most common side effects reported in clinical trials include:

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

More serious reactions to watch for include severely low blood cell counts (which can cause dangerous infections or bleeding), liver injury, and a serious lung infection called Pneumocystis pneumonia (PCP). If you develop a fever, unusual bruising, yellowing of the skin or eyes, or new difficulty breathing, contact your medical team right away.

⚠️Warnings & precautions▾
  • Myelosuppression (low blood cell counts): This is the most common serious risk. It can affect white blood cells, platelets, and red blood cells — sometimes severely. Women and older adults (especially over 70) are at higher risk. Regular blood monitoring is essential throughout treatment.
  • Liver toxicity (hepatotoxicity): Fatal and severe liver injury have been reported. Liver function tests are done before, during, and after treatment.
  • Pneumocystis pneumonia (PCP): A serious lung infection that can develop, especially in patients taking steroids or with prolonged treatment. Preventive medication (PCP prophylaxis) is required during certain treatment phases.
  • Secondary cancers: Cases of myelodysplastic syndrome (a bone marrow disorder) and blood cancers such as myeloid leukemia have been reported after temozolomide treatment.
  • Fetal harm: Temozolomide can cause serious birth defects and miscarriage. Effective contraception is required during treatment and for several months afterward for both men and women.
🔀What it interacts with▾

The label identifies a small number of clinically relevant drug interactions to be aware of:

  • Valproic acid (used for seizures or mood disorders) — may reduce how fast temozolomide is cleared from the body by about 5%; your doctor should know if you take it
  • Ranitidine (an acid-reducing drug) — no clinically significant effect on temozolomide levels was observed in studies
  • Dexamethasone, phenytoin, carbamazepine, phenobarbital, ondansetron, prochlorperazine, and H2-receptor antagonists — no significant effect on temozolomide clearance was found in population analyses

This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.

📋Before taking it▾
  • Allergy to temozolomide or dacarbazine: Do not take temozolomide if you have had a serious allergic reaction (including anaphylaxis) to temozolomide, any capsule ingredient, or dacarbazine — they share an active metabolite
  • Pregnancy: Temozolomide can cause fetal harm, including malformations and pregnancy loss. Pregnancy should be ruled out before starting, and effective contraception must be used during treatment and for 6 months after the last dose (females) or 3 months (males using condoms)
  • Breastfeeding: Do not breastfeed during treatment or for 1 week after the last dose due to the risk of serious harm to the infant
  • Male fertility: Temozolomide may impair fertility and affect sperm; men should not donate semen during treatment or for 3 months after the last dose
  • Children: Safety and effectiveness have not been established in pediatric patients
  • Older adults (65+): Higher risk of severe blood count drops; extra monitoring is warranted, especially for those over 70
  • Severe kidney or liver disease: Safe dosing has not been established for patients with severely reduced kidney function or severe liver impairment — your doctor needs to know your full medical history
🚑If you take too much▾

Taking too much temozolomide can cause life-threatening drops in blood cell counts (myelosuppression), fever, multi-organ failure, and has resulted in death in reported cases. If an overdose is suspected, blood counts should be monitored closely and supportive medical care provided immediately.

📡Pharmacodynamics — effects in the body▾

Temozolomide damages the DNA of cancer cells, triggering their programmed death. However, the precise relationship between drug exposure and the degree of tumor response — and the timing of that response — is not fully characterized based on current data.

🔬Pharmacokinetics — how your body processes it▾

After an oral dose, temozolomide is absorbed quickly, typically reaching peak blood levels in about 1 hour. A high-fat meal can reduce the peak concentration by about 32% and delay absorption, so consistent food timing matters. The drug has a short half-life of approximately 1.8 hours and is mostly excreted in the urine. It spontaneously converts to its active form (MTIC) at normal body pH — no liver enzymes are needed for this step — and the oral and IV forms produce very similar drug exposures at the same dose.

📦How to store it▾

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 Temozolomide’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. 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.

🩺 Pharmacist Counseling Corner

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 used for? ▾
Temozolomide is a chemotherapy drug used to treat aggressive brain tumors in adults. It's most commonly used for glioblastoma — one of the most serious types of brain cancer — given alongside radiation first and then continued on its own. It's also used for a tumor called anaplastic astrocytoma, either after radiation or when the tumor has stopped responding to other treatments. Your specific situation will determine which approach your oncologist uses.
Should I take this with food or on an empty stomach? ▾
Food does affect how temozolomide is absorbed — a high-fat meal can reduce how much reaches your bloodstream and slow its absorption. That said, your prescriber will give you specific guidance based on your treatment plan. The key is to be consistent — don't switch back and forth — and always follow the instructions you were given rather than guessing.
What side effects should I actually expect, and which ones mean I need to call someone right away? ▾
The most common things people notice are nausea, vomiting, fatigue, hair loss, headache, constipation, and reduced appetite — these are expected and your team can help manage them. What you really need to call about right away is any fever, unusual bruising or bleeding, signs of infection, or new shortness of breath or cough — those could mean your blood counts have dropped to a dangerous level or that you've developed a serious lung infection. Yellowing of the skin or eyes also needs immediate attention, as it can signal liver problems.
Why do I need so many blood tests while I'm on this drug? ▾
Temozolomide can significantly lower your white blood cells, platelets, and red blood cells — sometimes to the point where you'd need hospitalization or a transfusion. Blood tests let your doctor catch this early and adjust your dose or pause treatment before things become dangerous. Think of them as your safety net throughout treatment. Women and older adults tend to need especially close monitoring.
Is it safe if I'm pregnant or planning to get pregnant? ▾
Temozolomide is not safe during pregnancy. It has caused serious birth defects and pregnancy loss in both animal studies and in people. If you're a woman of childbearing age, you'll need a pregnancy test before starting, and you must use reliable contraception during treatment and for 6 months after your last dose. If you're a man, you need to use condoms and avoid donating sperm during treatment and for 3 months after. Please talk to your doctor right away if pregnancy becomes a concern at any point.
Can I open the capsule if I have trouble swallowing it? ▾
No — do not open, crush, or chew the capsules. The powder inside is a hazardous chemotherapy drug, and if it contacts your skin or the lining of your mouth, it can cause harm. Swallow them whole with a full glass of water. If a capsule breaks accidentally, avoid touching the powder, flush the area with water right away, and let your pharmacist or care team know. If swallowing is a genuine problem, talk to your doctor — they can look into other options with you.
Is Temozolomide available over the counter? ▾
Temozolomide is dispensed by prescription according to its FDA labeling, so it isn't sold over the counter. Your prescriber and pharmacist will determine if it's appropriate for you.
When was Temozolomide first available? ▾
Temozolomide has been available in the United States since at least 1999, based on FDA approval history (Drugs@FDA) and product marketing records.
Who makes Temozolomide? ▾
Temozolomide is supplied by 30 manufacturers listed in the FDA NDC Directory, including Merck Sharp & Dohme LLC, Sun Pharmaceutical Industries, Inc., Accord Healthcare Inc..

💬 Answers drafted from Temozolomide’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →

🧰 Keep exploring

📊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

💊 How Temozolomide 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.

Capsule

By mouth
Brands Temodar
How this form is used
What it may be used for
  • Temodar capsules are used for newly diagnosed glioblastoma (with radiation and then as maintenance) and for adjuvant or refractory anaplastic astrocytoma in adults
  • Temozolomide Capsules, USP are used for newly diagnosed glioblastoma and for refractory anaplastic astrocytoma in adults who progressed on nitrosourea- and procarbazine-containing regimens
Important instructions
  • Swallow capsules whole with a glass of water — do not open, chew, or dissolve them
  • If a capsule is damaged and powder is exposed, avoid skin or mucous membrane contact and wash the area immediately with water
  • Food can reduce the speed and amount of drug absorbed; follow your prescriber's specific guidance on taking with or without food
  • Temozolomide Capsules, USP must be dispensed in a separate vial or original package clearly listing the strength per capsule to prevent dosing errors
Available strengths 7 strengths
5 mg 20 mg 100 mg 140 mg 180 mg 250 mg
Show 1 more strength Show fewer strengths
180 1
209 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 in adults, administered intravenously alongside radiation therapy and then as maintenance
  • Temodar injection is also used intravenously 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 by a healthcare professional in a clinical setting
  • Temodar can be administered either intravenously or orally depending on the treatment phase and prescriber decision — do not switch forms without medical guidance
Available strengths 1 strength
2.5 mg/mL
4 FDA-listed product records ⓘ

📊 Temozolomide across the U.S. market

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.

2
Dose forms ⓘ
30
Manufacturers
2
Brand names
228
FDA-listed product records ⓘ
1999
First marketed ⓘ

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 LLC9%
Sun Pharmaceutical Industries, Inc.8%
Accord Healthcare Inc.8%
Amneal Pharmaceuticals LLC8%
Ascend Laboratories, LLC8%
Rising Pharmaceuticals, Inc.5%
Other makers54%

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

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 1,596 medications we measure, Temozolomide ranks #1,050 by Medicaid prescriptions — more than 34% of them.

Where Temozolomide ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5
Total prescriptions — #1,050 of 1,596
#1,045 Lanthanum 4,990 Rx #1,046 Acalabrutinib 4,921 Rx #1,047 Ciprofloxacin Injectio... 4,872 Rx #1,048 Lanreotide Injection 4,864 Rx #1,049 Alcohol 4,861 Rx #1,050 Temozolomide 4,846 Rx #1,051 Hydralazine / Isosorbi... 4,770 Rx #1,052 Teduglutide Injection 4,744 Rx #1,053 Rifapentine 4,737 Rx #1,054 Dronabinol 4,723 Rx #1,055 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 200 of 228 products — FDA National Drug Code Directory. See every product, package size and price: browse all 228 Temozolomide NDCs →

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.

🏷️ Sold under these brand names

Temodar

🏭 Manufacturers & labelers

Merck Sharp & Dohme LLC 21 Sun Pharmaceutical Industries, Inc. 19 Accord Healthcare Inc. 18 Amneal Pharmaceuticals LLC 18 Ascend Laboratories, LLC 18 Rising Pharmaceuticals, Inc. 12 Rising Pharma Holdings, Inc. 12 CivicaScript LLC 12 Areva Pharmaceuticals 11 OPKO Pharmaceuticals, LLC 8 Bryant Ranch Prepack 6 Camber Pharmaceuticals, Inc. 6 Zydus Pharmaceuticals USA Inc. 6 Devatis, Inc. 6 Excella GmbH & Co. KG 6 Zydus Pharmaceuticals (USA) Inc. 6 Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. 6 Zydus Lifesciences Limited 6 Lannett Company, Inc. 6 Nivagen Pharmaceuticals, Inc. 6 ANI Pharmaceuticals, Inc. 6 AvPAK 4 American Pacific Corporation 2 Shilpa Pharma Lifesciences Limited 1

…and 6 more on the FDA NDC directory.

RxNorm drug class

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.

🔬 Where this comes from

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
NDC products indexed
228
Distinct labelers/manufacturers represented
30
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 we combine label and product data

HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 20 FDA-filed SPL label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.

For canonical ingredient pages, bounded product-attributed indication and administration excerpts may be added to the AI evidence, and the generator is instructed to preserve available product, brand, route, and form qualifiers instead of treating one label as universal. Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Merck Sharp & Dohme LLC is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.

This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.