Common Temozolomide Side Effects


The most commonly reported Temozolomide side effects (click to view or check a box to report):

Platelet Count Decreased (200)
Thrombocytopenia (190)
Asthenia (173)
Nausea (165)
Disease Progression (162)
Febrile Neutropenia (142)
Pneumonia (128)
White Blood Cell Count Decreased (124)
Pyrexia (121)
Convulsion (121)
Dehydration (119)
Vomiting (119)
Pulmonary Embolism (117)
Fatigue (107)
Confusional State (104)
Neutropenia (103)
Pancytopenia (90)
Dyspnoea (82)
Fall (80)
Headache (79)

➢ More



If you or someone in your family has experienced a serious side effect to a health product, you are encouraged to report the experience to your health care professional (e.g. physician, pharmacist). You could also complete a copy of the side effect reporting form or report your side effect to FDA.

Temozolomide Side Effects Reported to FDA



Temozolomide Side Effect Report#9999328
Leukopenia, Lymphopenia
This is a report of a 68-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: small cell lung cancer metastatic, who was treated with Temozolomide (dosage: 150 Mg/m2 Daily D1-5 Q28d, start time: NS), combined with:
  • Etoposide (100 Mg/m2 D1-10 Q28d)
and developed a serious reaction and side effect(s): Leukopenia, Lymphopenia after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Temozolomide treatment in female patients, resulting in Leukopenia side effect.
Temozolomide Side Effect Report#9999319
Neutropenia, Leukopenia, Lymphopenia
This report suggests a potential Temozolomide Neutropenia side effect(s) that can have serious consequences. A 64-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: small cell lung cancer metastatic and used Temozolomide (dosage: 150 Mg/m2 D1-5 Q28) starting NS. After starting Temozolomide the patient began experiencing various side effects, including: Neutropenia, Leukopenia, LymphopeniaAdditional drugs used concurrently:
  • Etoposide (50 Mg/m2 D1-10 Q28)
Although Temozolomide demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Neutropenia, may still occur.
Temozolomide Side Effect Report#9984732
Bone Marrow Failure, Leukopenia, Lymphopenia, Fatigue, Metastases To Central Nervous System
This Death problem was reported by a health professional from US. A 68-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On NS this consumer started treatment with Temozolomide (dosage: 150 Mg/m2, Unk). The following drugs were being taken at the same time:
  • Carboplatin
  • Etoposide
  • Etoposide (100 Mg/m2, Unk)
When using Temozolomide, the patient experienced the following unwanted symptoms/side effects: Bone Marrow Failure, Leukopenia, Lymphopenia, Fatigue, Metastases To Central Nervous SystemAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Death, may become evident only after a product is in use by the general population.
Temozolomide Side Effect Report#9981000
Disease Progression, Bone Marrow Failure, Eosinophil Count Increased, Basophil Count Increased, Monocyte Count Increased, Nausea, Malaise, Constipation, White Blood Cell Count Decreased
This Disease Progression side effect was reported by a consumer or non-health professional from JP. A 55-year-old male patient (weight:NA) experienced the following symptoms/conditions: gliomatosis cerebri.The patient was prescribed Temozolomide (drug dosage: 150 Mg/m2, Qd), which was initiated on
Jan 15, 2007. Concurrently used drugs: NA..After starting to take Temozolomide the consumer reported adverse symptoms, such as: Disease Progression, Bone Marrow Failure, Eosinophil Count Increased, Basophil Count Increased, Monocyte Count Increased, Nausea, Malaise, Constipation, White Blood Cell Count DecreasedThese side effects may potentially be related to Temozolomide.
Temozolomide Side Effect Report#9972690
Disease Progression, Hepatic Function Abnormal, Blood Creatinine Increased, White Blood Cell Count Decreased, Lymphocyte Count Decreased
This is a report of a 75-year-old male patient (weight: NA) from JP, suffering from the following health symptoms/conditions: anaplastic astrocytoma, who was treated with Temozolomide (dosage: 100 Mg/m2, Qd, start time:
Jun 29, 2009), combined with: NA. and developed a serious reaction and side effect(s): Disease Progression, Hepatic Function Abnormal, Blood Creatinine Increased, White Blood Cell Count Decreased, Lymphocyte Count Decreased after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Temozolomide treatment in male patients, resulting in Disease Progression side effect. The patient was hospitalized.
Temozolomide Side Effect Report#9972461
Sepsis
This report suggests a potential Temozolomide 180mg Teva Sepsis side effect(s) that can have serious consequences. A 76-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: brain neoplasm malignant and used Temozolomide 180mg Teva (dosage: 1 Cap Qd) starting NS. After starting Temozolomide 180mg Teva the patient began experiencing various side effects, including: SepsisAdditional drugs used concurrently:
  • Temozolomide 140mg Teva (1 Cap)
  • Granisetron
  • Pepcid
  • Coumadin
  • Ambien
  • Percocet
The patient was hospitalized. Although Temozolomide 180mg Teva demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Sepsis, may still occur.
Temozolomide Side Effect Report#9959585
Alanine Aminotransferase Increased, Toxicity To Various Agents
This Alanine Aminotransferase Increased problem was reported by a physician from US. A 50-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: glioblastoma. On
Dec 30, 2013 this consumer started treatment with Temozolomide (dosage: 75mg/m2 140mg Days 1-28). The following drugs were being taken at the same time:
  • Nexium
  • Acyclovir
  • Keppra
  • Lisinopril
When using Temozolomide, the patient experienced the following unwanted symptoms/side effects: Alanine Aminotransferase Increased, Toxicity To Various AgentsAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Alanine Aminotransferase Increased, may become evident only after a product is in use by the general population.
Temozolomide Side Effect Report#9935649
Neutropenic Sepsis, Demyelination
This Neutropenic Sepsis side effect was reported by a health professional from GB. A 58-year-old male patient (weight:NA) experienced the following symptoms/conditions: glioblastoma.The patient was prescribed Temozolomide (drug dosage: Unk), which was initiated on NS. Concurrently used drugs:
  • Dexamethasone (4 Mg, Qd)
  • Tazocin
  • Atenolol
  • Lisinopril
  • Metformin
  • Levothyroxine Sodium
.After starting to take Temozolomide the consumer reported adverse symptoms, such as: Neutropenic Sepsis, DemyelinationThese side effects may potentially be related to Temozolomide. The patient was hospitalized.
Temozolomide Side Effect Report#9921940
Myeloid Maturation Arrest, Thrombocytopenia, Platelet Count Decreased, Haemorrhagic Diathesis, Petechiae, Leukopenia, Bone Marrow Failure, Sepsis, Pyrexia
This is a report of a 61-year-old female patient (weight: NA) from CZ, suffering from the following health symptoms/conditions: NA, who was treated with Temozolomide (dosage: 75 Mg/m2/day, start time: NS), combined with:
  • Co-trimoxazole
  • Citalopram (20 Mg/day)
and developed a serious reaction and side effect(s): Myeloid Maturation Arrest, Thrombocytopenia, Platelet Count Decreased, Haemorrhagic Diathesis, Petechiae, Leukopenia, Bone Marrow Failure, Sepsis, Pyrexia after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Temozolomide treatment in female patients, resulting in Myeloid Maturation Arrest side effect. The patient was hospitalized.
Temozolomide Side Effect Report#9919586
Bone Marrow Toxicity, Brain Mass, Radiation Necrosis
This report suggests a potential Temozolomide Bone Marrow Toxicity side effect(s) that can have serious consequences. A 61-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: glioblastoma and used Temozolomide (dosage: NA) starting NS. After starting Temozolomide the patient began experiencing various side effects, including: Bone Marrow Toxicity, Brain Mass, Radiation NecrosisAdditional drugs used concurrently: NA. Although Temozolomide demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Bone Marrow Toxicity, may still occur.
Temozolomide Side Effect Report#9913855
Nausea, Vomiting, Vomiting, Underdose, Abdominal Discomfort, Product Substitution Issue
This Nausea problem was reported by a physician from US. A 55-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: brain neoplasm malignant. On
Jan 22, 2014 this consumer started treatment with Temozolomide (dosage: D14 X 5 Q28day). The following drugs were being taken at the same time: NA. When using Temozolomide, the patient experienced the following unwanted symptoms/side effects: Nausea, Vomiting, Vomiting, Underdose, Abdominal Discomfort, Product Substitution IssueAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Nausea, may become evident only after a product is in use by the general population.
Temozolomide Side Effect Report#9912536
Thrombosis
This Thrombosis side effect was reported by a pharmacist from US. A 42-year-old female patient (weight:NA) experienced the following symptoms/conditions: brain neoplasm malignant.The patient was prescribed Temozolomide (drug dosage: NA), which was initiated on
Nov 26, 2013. Concurrently used drugs: NA..After starting to take Temozolomide the consumer reported adverse symptoms, such as: ThrombosisThese side effects may potentially be related to Temozolomide.
Temozolomide Side Effect Report#9892890
Intracranial Tumour Haemorrhage, Headache, Hepatic Function Abnormal, Constipation, Pneumonia, Pneumonia, Hyponatraemia
This is a report of a 79-year-old male patient (weight: NA) from JP, suffering from the following health symptoms/conditions: anaplastic astrocytoma, who was treated with Temozolomide (dosage: 75 Mg/m2, Qd, start time:
Nov 22, 2010), combined with:
  • Warfarin (Unk)
  • Prednisolone (Unk)
  • Gaster D (Unk)
  • Fructose (+) Glycerin (Unk)
  • Rinderon (betamethasone) (Unk)
  • Gaster (Unk)
and developed a serious reaction and side effect(s): Intracranial Tumour Haemorrhage, Headache, Hepatic Function Abnormal, Constipation, Pneumonia, Pneumonia, Hyponatraemia after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Temozolomide treatment in male patients, resulting in Intracranial Tumour Haemorrhage side effect.
Temozolomide Side Effect Report#9891587
Haematotoxicity, Haematotoxicity
This report suggests a potential Temozolomide Haematotoxicity side effect(s) that can have serious consequences. A 8-year-old female patient (weight: NA) from DE was diagnosed with the following symptoms/conditions: brain stem glioma and used Temozolomide (dosage: 75 Mg/m2(n=5), Qd) starting NS. After starting Temozolomide the patient began experiencing various side effects, including: Haematotoxicity, HaematotoxicityAdditional drugs used concurrently: NA. Although Temozolomide demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Haematotoxicity, may still occur.
Temozolomide Side Effect Report#9891513
Haematotoxicity, Haematotoxicity
This Haematotoxicity problem was reported by a health professional from DE. A 4-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: glioma. On NS this consumer started treatment with Temozolomide (dosage: 75 Mg/m2 (n=5), Qd). The following drugs were being taken at the same time: NA. When using Temozolomide, the patient experienced the following unwanted symptoms/side effects: Haematotoxicity, HaematotoxicityAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Haematotoxicity, may become evident only after a product is in use by the general population.
Temozolomide Side Effect Report#9890866
Metastases To Liver, Surgery, Monoparesis, Pulmonary Mass, Hepatic Neoplasm, Pleural Effusion
This Death side effect was reported by a physician from BR. A 14-year-old female patient (weight:NA) experienced the following symptoms/conditions: neoplasm.The patient was prescribed Temozolomide (drug dosage: NA), which was initiated on NS. Concurrently used drugs:
  • Cisplatin
  • Vepesid
  • Vinorelbine Tartrate
.After starting to take Temozolomide the consumer reported adverse symptoms, such as: Metastases To Liver, Surgery, Monoparesis, Pulmonary Mass, Hepatic Neoplasm, Pleural EffusionThese side effects may potentially be related to Temozolomide.
Temozolomide Side Effect Report#9882678
Sepsis, Pyrexia, Pneumonia, Fungal Infection, Dry Skin, Restlessness, Hepatic Function Abnormal, Anaemia, Lymphocyte Count Decreased
This is a report of a 77-year-old female patient (weight: NA) from JP, suffering from the following health symptoms/conditions: anaplastic astrocytoma,fungal infection,pneumonia, who was treated with Temozolomide (dosage: 75 Mg/m2, Qd, start time:
Jan 08, 2010), combined with:
  • Prodif (Unk)
  • Vancomycin (Unk)
  • Funguard (Unk)
  • Warfarin (Unk)
  • Coniel (Unk)
  • Cardenalin (Unk)
  • Takepron (Unk)
  • Prednisolone (Unk)
and developed a serious reaction and side effect(s): Sepsis, Pyrexia, Pneumonia, Fungal Infection, Dry Skin, Restlessness, Hepatic Function Abnormal, Anaemia, Lymphocyte Count Decreased after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Temozolomide treatment in female patients, resulting in Sepsis side effect.
Temozolomide Side Effect Report#9881483
Disease Progression, Inflammation Of Wound, Subcutaneous Abscess, Cytomegalovirus Infection, Constipation, Anaemia, Lymphocyte Count Decreased, White Blood Cell Count Decreased
This report suggests a potential Temozolomide Disease Progression side effect(s) that can have serious consequences. A 76-year-old male patient (weight: NA) from JP was diagnosed with the following symptoms/conditions: glioblastoma multiforme and used Temozolomide (dosage: 150 Mg/m2, Qd) starting
Apr 04, 2011. After starting Temozolomide the patient began experiencing various side effects, including: Disease Progression, Inflammation Of Wound, Subcutaneous Abscess, Cytomegalovirus Infection, Constipation, Anaemia, Lymphocyte Count Decreased, White Blood Cell Count DecreasedAdditional drugs used concurrently: NA.The patient was hospitalized. Although Temozolomide demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Disease Progression, may still occur.
Temozolomide Side Effect Report#9881365
Disease Progression, Constipation, Anaemia
This Disease Progression problem was reported by a consumer or non-health professional from JP. A 69-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: glioblastoma multiforme. On
Oct 16, 2011 this consumer started treatment with Temozolomide (dosage: 75 Mg/m2, Qd). The following drugs were being taken at the same time:
  • Temodal
  • Temodal
  • Baktar
  • Warfarin Potassium
  • Prednisolone
  • Urso
  • Bezatol Sr
  • Excegran
When using Temozolomide, the patient experienced the following unwanted symptoms/side effects: Disease Progression, Constipation, AnaemiaAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Disease Progression, may become evident only after a product is in use by the general population.
Temozolomide Side Effect Report#9879856
Exposure During Pregnancy
This Exposure During Pregnancy side effect was reported by a health professional from US. A 27-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Temozolomide (drug dosage: NA), which was initiated on NS. Concurrently used drugs: NA..After starting to take Temozolomide the consumer reported adverse symptoms, such as: Exposure During PregnancyThese side effects may potentially be related to Temozolomide.
Temozolomide Side Effect Report#9875285
Disease Progression, Unevaluable Event
This is a report of a 73-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: malignant melanoma, who was treated with Temozolomide (dosage: NA, start time:
Jan 07, 2014), combined with: NA. and developed a serious reaction and side effect(s): Disease Progression, Unevaluable Event after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Temozolomide treatment in female patients, resulting in Disease Progression side effect.
Temozolomide Side Effect Report#9874412
Disease Progression, Neutropenia, Thrombocytopenia
This report suggests a potential Temozolomide Disease Progression side effect(s) that can have serious consequences. A 50-year-old male patient (weight: NA) from HK was diagnosed with the following symptoms/conditions: glioblastoma multiforme and used Temozolomide (dosage: 200 Mg/m2 Q4w) starting 2011. After starting Temozolomide the patient began experiencing various side effects, including: Disease Progression, Neutropenia, ThrombocytopeniaAdditional drugs used concurrently: NA. Although Temozolomide demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Disease Progression, may still occur.
Temozolomide Side Effect Report#9871063
Disease Progression
This Disease Progression problem was reported by a consumer or non-health professional from US. A 51-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: soft tissue neoplasm. On
Aug 23, 2011 this consumer started treatment with Temozolomide (dosage: NA). The following drugs were being taken at the same time:
  • Votrient
  • Calcium Chews
  • Multvitamin
When using Temozolomide, the patient experienced the following unwanted symptoms/side effects: Disease ProgressionAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Disease Progression, may become evident only after a product is in use by the general population.
Temozolomide Side Effect Report#9866430
Neutropenia, Agranulocytosis, Bone Marrow Failure, Thrombocytopenia
This Neutropenia side effect was reported by a physician from NO. A 66-year-old female patient (weight:NA) experienced the following symptoms/conditions: glioblastoma.The patient was prescribed Temozolomide (drug dosage: 120 Mg, Qd), which was initiated on
May 29, 2013. Concurrently used drugs: NA..After starting to take Temozolomide the consumer reported adverse symptoms, such as: Neutropenia, Agranulocytosis, Bone Marrow Failure, ThrombocytopeniaThese side effects may potentially be related to Temozolomide.
Temozolomide Side Effect Report#9859778
Disease Progression, Platelet Count Decreased, Decreased Appetite, White Blood Cell Count Decreased, Haematocrit Decreased, Neutrophil Count Increased, Hypercreatininaemia, C-reactive Protein Increased, Hyponatraemia
This is a report of a 64-year-old female patient (weight: NA) from JP, suffering from the following health symptoms/conditions: anaplastic astrocytoma, who was treated with Temozolomide (dosage: 75 Mg/m2, Qd, start time:
Jan 16, 2012), combined with: NA. and developed a serious reaction and side effect(s): Disease Progression, Platelet Count Decreased, Decreased Appetite, White Blood Cell Count Decreased, Haematocrit Decreased, Neutrophil Count Increased, Hypercreatininaemia, C-reactive Protein Increased, Hyponatraemia after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Temozolomide treatment in female patients, resulting in Disease Progression side effect. The patient was hospitalized.


1 of 80 


The appearance of Temozolomide on this list does not mean that FDA has concluded that the drug has the listed risk. It means that FDA has identified a potential safety issue, but it does not mean that FDA has found a causal relationship between the drug and the listed risk.

What are common Temozolomide Side Effects for Women?

Women Side Effects Reports
Platelet Count Decreased 123
Thrombocytopenia 108
White Blood Cell Count Decreased 96
Febrile Neutropenia 87
Asthenia 86
Nausea 82
Disease Progression 69
Pneumonia 67
Neutropenia 62
Dehydration 60

What are common Temozolomide Side Effects for Men?

Men Side Effects Reports
Disease Progression 92
Asthenia 86
Nausea 80
Platelet Count Decreased 77
Thrombocytopenia 77
Pulmonary Embolism 70
Convulsion 68
Confusional State 66
Pyrexia 60
Pneumonia 59

Track Your Side Effects

Note Your Observations

It is really important to keep track of your health symptoms, right from the time you start a new medicine. You can do it any way you prefer: in a notebook, in a computer file or using our online tool. You should also note down any other medicines you are taking at the same time, because there could be an interaction between these medicines.

Why Your Notes are Important

Your notes could be helpful in several ways:

  • You can use them to remind you of details that may alert your health care professional(s) to a problem
  • You will have a record to refer to in the future, in case you are ever prescribed the same medicine again

  • Log Form

    You can use the following log form to write down important information, like the date and time you experienced a side effect and your symptoms, how strong the symptoms were, and any other medicines you were using.

    Medicine Name and Dosage:
    Side Effects Scale Date & Time Other Medicine(s) or Treatment(s)
    Scale: 1 = very mild to 10 = very bad

    Side effects reports are analyzed to discover potential health product safety signals. Some important reactions may take an extremely long time to develop or occur infrequently. Continued monitoring of adverse reactions is thus essential to maintain a comprehensive safety and effectiveness profile of health products.

    You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

    Temozolomide reports list potential signals of serious risks and new safety information that were identified using the FDA Adverse Event Reporting System (FAERS).
    FAERS is a database that contains information on adverse event and medication errors reports submitted to FDA by healthcare professionals (such as physicians, pharmacists, nurses and others), consumers (such as patients, family members, layers and others) and manufacturers.

    Discuss Temozolomide Side Effects

    Did You Have a Temozolomide Side Effect?

    Yes, Severe
    Yes, Moderate
    Yes, Minor
    No

    How Effective is Temozolomide for You?

    Exceeded Expectations
    Effective
    Somewhat Effective
    Not Effective

    Temozolomide Safety Alerts, Active Ingredients, Usage Information

    NDC 0093-7599
    Type HUMAN PRESCRIPTION DRUG
    Proprietary Name Temozolomide
    Name Temozolomide
    Dosage Form CAPSULE
    Route ORAL
    On market since 20130812
    Labeler Teva Pharmaceuticals USA Inc
    Active Ingredient(s) TEMOZOLOMIDE
    Strength(s) 5
    Unit(s) mg/1
    Pharma Class Alkylating Activity [MoA],Alkylating Drug [EPC]

    More About Temozolomide

    Side Effects reported to FDA: 1986

    Temozolomide safety alerts: No

    Reported deaths: 384

    Reported hospitalizations: 1369

    Latest Temozolomide clinical trials

    Temozolomide Reviews

    No reviews, be a first to report a side effect via side effect reporting form