Medication-info.com Search Menu

Temozolomide (Temodar): Uses, Side Effects and Dosage

Updated:
Facts
Status:
Prescription (Rx)
Strength:
5 mg, 20 mg, 100 mg, 140 mg, 180 mg, 250 mg
Brand names:
Drug class:
Active ingredient:
Similar drugs:

Source: FDA drug labeling via NLM DailyMed · About this document

Patient information: uses, side effects, how to take - Temozolomide

What is TEMOZOLOMIDE?

TEMOZOLOMIDE is a prescription medicine used to treat adults with certain brain cancer tumors. It is not known if TEMOZOLOMIDE is safe and effective in children.

Do not take TEMOZOLOMIDE if you:

  • have had an allergic reaction to temozolomide or any of the other ingredients in TEMOZOLOMIDE. See the end of this leaflet for a list of ingredients in TEMOZOLOMIDE. Symptoms of an allergic reaction with TEMOZOLOMIDE may include: a red itchy rash, or a severe allergic reaction, such as trouble breathing, swelling of the face, throat, or tongue, or severe skin reaction. If you are not sure, ask your doctor.
  • have had an allergic reaction to dacarbazine (DTIC), another cancer medicine.

Before taking or receiving TEMOZOLOMIDE, tell your healthcare provider about all of your medical conditions, including if you:

  • have kidney problems
  • have liver problems

  • are pregnant or plan to become pregnant. TEMOZOLOMIDE can harm your unborn baby and cause birth defects. Females who can become pregnant:

  • You should not become pregnant during treatment with TEMOZOLOMIDE.
  • You should use an effective form of birth control (contraception) during treatment and for 6 months after your last dose of TEMOZOLOMIDE.
  • Your healthcare provider should do a pregnancy test to make sure that you are not pregnant before you start taking TEMOZOLOMIDE.
  • Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with TEMOZOLOMIDE.

Males with a female partner who is pregnant or who can become pregnant:

  • Use a condom for birth control (contraception) during treatment and for 3 months after taking your last dose of TEMOZOLOMIDE.
  • Do not donate semen during treatment and for 3 months after your last dose of TEMOZOLOMIDE.
  • are breast-feeding or plan to breastfeed. It is not known if TEMOZOLOMIDE passes into your breast milk. Do not breastfeed during treatment and for 1 week after your last dose of TEMOZOLOMIDE.

Tell your doctor about all the medicines you take,including prescription and non-prescription medicines, vitamins, and herbal supplements.

Know the medicines you take. Keep a list of them and show it to your healthcare provider and pharmacist when you get a new medicine.

How should I take TEMOZOLOMIDE?

TEMOZOLOMIDE may be taken 2 different ways:

  • you may take TEMOZOLOMIDE by mouth as a capsule, or

  • you may receive TEMOZOLOMIDE as an intravenous (IV) injection into your vein.

    Your healthcare provider will decide the best way for you to take TEMOZOLOMIDE.

  • If your healthcare provider prescribes TEMOZOLOMIDE capsules for you, take the capsules exactly as prescribed.

There are 2 common dosing schedules for taking or receiving TEMOZOLOMIDE depending on the type of brain cancer tumor that you have.

  • People with certain brain cancer tumors take or receive TEMOZOLOMIDE:

    • 1 time each day for 42 to 49 days in a row, along with receiving radiation treatment.

      This is 1 cycle of treatment.

      After this, your healthcare provider may prescribe 6 more cycles of TEMOZOLOMIDE as “maintenance” treatment. For each of these cycles, you take or receive TEMOZOLOMIDE 1 time each day for 5 days in a row and then you stop taking it for the next 23 days. This is a 28-day maintenance treatment cycle.

  • People with certain other brain cancer tumors take or receive TEMOZOLOMIDE:

    • 1 time each day for 5 days in a row only, and then stop taking it for the next 23 days. This is 1 cycle of treatment (28 days).
    • Your healthcare provider will watch your progress on TEMOZOLOMIDE and decide how long you should take it.
  • If your healthcare provider prescribes a treatment regimen that is different from the information in this leaflet, make sure you follow the instructions given to you by your healthcare provider.
  • Your healthcare provider may change your dose of TEMOZOLOMIDE, or tell you to stop TEMOZOLOMIDE for a short period of time or permanently if you have certain side effects.
  • Your healthcare provider will decide how many treatment cycles of TEMOZOLOMIDE that you will receive, depending on how you respond to and tolerate treatment.

TEMOZOLOMIDE Capsules , USP :

  • Take TEMOZOLOMIDE Capsules, USP exactly as your healhtcare provider tells you to.
  • TEMOZOLOMIDE capsules contain a white capsule body with a color cap and the colors vary based on the dosage strength. Your healhtcare provider may prescribe more than 1 strength of TEMOZOLOMIDE capsules, USP for you, so it is important that you understand how to take your medicine the right way. Be sure that you understand exactly how many capsules you need to take on each day of your treatment, and what strengths to take. This may be different whenever you start a new cycle.
  • Do not take more TEMOZOLOMIDE than prescribed.
  • Talk to your healhtcare provider or pharmacist before taking your dose if you are not sure how much TEMOZOLOMIDE to take. This will help to prevent taking too much TEMOZOLOMIDE and decrease your chances of getting serious side effects.
  • Take each day’s dose of TEMOZOLOMIDE Capsules, USP at one time, with a full glass of water.
  • Take TEMOZOLOMIDE capsules, USP at the same time each day.
  • Take TEMOZOLOMIDE the same way each time, either with food or without food.
  • Swallow TEMOZOLOMIDE Capsules, USP whole with water. Do not open, chew, or dissolve the contents of the capsules.

  • If TEMOZOLOMIDE Capsules, USP

    are accidentally opened or damaged, be careful not to breathe in (inhale) the powder from the capsules or get the powder on your skin or mucous membranes (for example, in your nose or mouth). If contact with any of these areas happens, wash the area with water right away.

  • To help reduce nausea and vomiting, try to take TEMOZOLOMIDE on an empty stomach or at bedtime. Your healthcare provider may prescribe medicine to help prevent or treat nausea, or other medicines to reduce side effects with TEMOZOLOMIDE.

  • See your healthcare provider regularly to check your progress. Your healthcare provider will check you for side effects.
  • If you take more TEMOZOLOMIDE than prescribed, call your healthcare provider or get emergency medical help right away.

What are the possible side effects of TEMOZOLOMIDE?

TEMOZOLOMIDE can cause serious side effects, including:

  • Decreased blood cell counts. TEMOZOLOMIDE can affect your bone marrow and cause you to have decreased blood cell counts. Decreased white blood cell count, red blood cell count and platelet count are common with TEMOZOLOMIDE but it can also be severe and lead to death. Some people need to be hospitalized or need to receive transfusions to treat their decreased blood cell counts.

    • Your healthcare provider will do blood tests regularly to check your blood cell counts before you start and during treatment with TEMOZOLOMIDE.
    • Your healthcare provider may need to change the dose of TEMOZOLOMIDE, or when you get it depending on your blood cell counts
    • People who are age 70 or older and women have a higher risk for developing decreased blood cell counts during treatment with TEMOZOLOMIDE.
  • Liver problems. Liver problems can happen with TEMOZOLOMIDE and can sometimes be severe and lead to death. Your healthcare provider will do blood tests to check your liver function before you start taking TEMOZOLOMIDE, during treatment, and about 2 to 4 weeks after your last dose of TEMOZOLOMIDE

  • Pneumocystis pneumonia (PCP). PCP is an infection that people can get when their immune system is weak. TEMOZOLOMIDE decreases white blood cells, which makes your immune system weaker and can increase your risk of getting PCP.

    • People who are taking steroid medicines or who stay on TEMOZOLOMIDE for a longer period of time may have an increased risk of getting PCP infection.
    • Anyone who takes TEMOZOLOMIDE will be watched carefully by their healthcare provider for low blood cell counts and this infection.
    • Tell your healthcare provider if you have any of the following signs and symptoms of PCP infection: shortness of breath, or fever, chills, dry cough.
  • Secondary cancers. Blood problems such as myelodysplastic syndrome (MDS) and new cancers (secondary cancers), including a certain kind of leukemia, can happen in people who take TEMOZOLOMIDE. Your healthcare provider will monitor you for this.

Common side effects with TEMOZOLOMIDE include:

  • hair loss
  • feeling tired
  • nausea and vomiting.
  • headache
  • constipation
  • loss of appetite
  • convulsions

Additional side effects seen with TEMOZOLOMIDE for injection:

  • pain, irritation, itching, warmth, swelling or redness at the site of infusion
  • bruising or small red or purple spots under the skin

TEMOZOLOMIDE can affect fertility in males and may affect your ability to father a child. Talk with your healthcare provider if fertility is a concern for you.

Tell your healthcare provider about any side effect that bothers you or that does not go away.

These are not all the possible side effects of TEMOZOLOMIDE. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store TEMOZOLOMIDE Capsules, USP?

  • Store TEMOZOLOMIDE Capsules, USP between 68°F to 77°F (20°C to 25°C).

Keep TEMOZOLOMIDE Capsules, USP out of the reach of children.

General information about the safe and effective use of TEMOZOLOMIDE.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use TEMOZOLOMIDE for a condition for which it was not prescribed. Do not give TEMOZOLOMIDE to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about TEMOZOLOMIDE that is written for health professionals.

What are the ingredients in TEMOZOLOMIDE?

TEMOZOLOMIDE capsules:

Active ingredient: temozolomide

Inactive ingredients: lactose anhydrous, sodium starch glycolate, colloidal silicon dioxide, tartaric acid, and stearic acid.

The body of the capsules is made of gelatin and titanium dioxide and is opaque white. The cap is also made of gelatin and the colors may vary based on the dosage strength. The capsule body and cap are imprinted with pharmaceutical branding ink, which contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, purified water, strong ammonia solution,

potassium hydroxide, and ferric oxide.

TEMOZOLOMIDE 5 mg: The opaque green cap contains gelatin, titanium dioxide, iron oxide yellow and FD&C Blue #2.

TEMOZOLOMIDE 20 mg: The opaque yellow cap contains gelatin, titanium dioxide and iron oxide yellow.

TEMOZOLOMIDE 100 mg: The opaque flesh cap contains gelatin, titanium dioxide and iron oxide red.

TEMOZOLOMIDE 140 mg: The transparent blue cap contains gelatin and FD&C Blue #2

TEMOZOLOMIDE 180 mg: The opaque orange cap contains gelatin, titanium dioxide and iron oxide red.

TEMOZOLOMIDE 250 mg: The opaque white cap contains gelatin and titanium dioxide.

Made in Turkey

Distributed by:

Devatis, Inc.

San Clemente, CA 92672

Revised: 11/2024

About this document

Source: FDA drug labeling via NLM DailyMed · Application number: ANDA 207658 · View the label on DailyMed

Revision date stated in the text: November 2024

Found a mistake? Write to us via the contact page.

The information on this site does not replace the advice of a doctor or pharmacist.

Drug information for Temozolomide

Rx or OTC
Prescription (Rx)?
  • This drug is available only with a prescription from a licensed healthcare provider.
  • Rx
Drug class Alkylating Drug
Active ingredient Temozolomide
Dosage form Capsule
Route Oral
Marketing status listed in the FDA NDC Directory
Company (applicant) DEVA HOLDING AS
FDA approval ANDA 207658Abbreviated New Drug Application (ANDA) – generic drug Approved April 26, 2017
Therapeutic equivalence (TE) code ABCodes starting with A mean the FDA rates the drug therapeutically equivalent to its reference drug (Orange Book).
Manufacturers 12 labelers list this drug on DailyMed
Recalls
  • March 3, 2026: Class II recall: Failed Impurities/Degradation Specifications: An out-of-specification result observed during 9th-month long term stability testing
Packages (NDC)
Package
5 mg – 5 in 1 bottle NDC 73043-011-05
5 mg – 14 in 1 bottle NDC 73043-011-14
20 mg – 5 in 1 bottle NDC 73043-012-05
20 mg – 14 in 1 bottle NDC 73043-012-14
100 mg – 5 in 1 bottle NDC 73043-013-05
100 mg – 14 in 1 bottle NDC 73043-013-14
140 mg – 5 in 1 bottle NDC 73043-014-05
140 mg – 14 in 1 bottle NDC 73043-014-14
180 mg – 5 in 1 bottle NDC 73043-015-05
180 mg – 14 in 1 bottle NDC 73043-015-14
250 mg – 5 in 1 bottle NDC 73043-016-05

Source: FDA drug labeling via NLM DailyMed, data as of October 31, 2026. FDA data (DailyMed, Orange Book, Drug Shortages, enforcement reports). Not a substitute for the advice of a doctor or pharmacist.