Temozolomide Side Effects

It is possible that some side effects of temozolomide may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

For the Consumer

Applies to temozolomide: oral capsule

As well as its needed effects, temozolomide may cause unwanted side effects that require medical attention.

If any of the following side effects occur while taking temozolomide, check with your doctor immediately:

Less common or rare
  • Amnesia
  • black, tarry stools
  • blood in the urine or stools
  • convulsions
  • cough or hoarseness
  • fever or chills
  • lower back or side pain
  • muscle weakness or paralysis on one or both sides of the body
  • painful or difficult urination
  • pinpoint red spots on the skin
  • swelling of the feet or lower legs
  • unusual bleeding or bruising
Incidence not known
  • Abdominal or stomach pain or tenderness
  • blistering, peeling, or loosening of the skin
  • chest pain
  • clay colored stools
  • cough
  • decreased appetite
  • diarrhea
  • difficulty swallowing
  • dizziness
  • fast heartbeat
  • headache
  • hives, itching, or skin rash
  • joint or muscle pain
  • nausea or vomiting
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • red skin lesions, often with a purple center
  • red, irritated eyes
  • sneezing
  • sore throat
  • sores, ulcers, or white spots in the mouth or on the lips
  • tightness in the chest
  • troubled breathing
  • unusual tiredness or weakness
  • yellow skin or eyes

Some temozolomide side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:

More common
  • Constipation
Less common or rare
  • Anxiety
  • blurred or double vision
  • breast pain (in females)
  • burning or prickling feeling on the skin
  • confusion
  • diarrhea
  • difficulty with speaking
  • drowsiness
  • increased urge to urinate
  • loss of appetite
  • loss of muscle coordination
  • mental depression
  • runny or stuffy nose
  • trouble sleeping
  • unusual weight gain

For Healthcare Professionals

Applies to temozolomide: intravenous powder for injection, oral capsule


Gastrointestinal effects including nausea (53%), vomiting (42%), constipation (33%), diarrhea (16%), abdominal pain (9%), and anorexia (9%) have been reported.


General effects including headache (41%), fatigue (34%), asthenia (13%), fever (13%), and back pain (8%) have been reported.

Nervous system

Nervous system effects including convulsions (23%), hemiparesis (18%), dizziness (12%), abnormal coordination (11%) amnesia (10%), insomnia (10%), paresthesia (9%), somnolence (9%), paresis (8%), urinary incontinence (8%), ataxia (8%), dysphasia (7%), local convulsions (6%), abnormal gait (6%), and confusion (5%) have been reported.


Cardiovascular effects including peripheral edema (11%) have been reported.


Other effects including viral infection (11%) have been reported.


Endocrine effects including adrenal hypercorticism (8%) have been reported.


Genitourinary effects including urinary tract infection (8%), increased frequency of micturition (6%) and female breast pain (6%) have been reported.


Respiratory effects including upper respiratory tract infection (8%), pharyngitis (8%), sinusitis (6%), and coughing (5%) have been reported. Cases of interstitial pneumonitis/pneumonitis, alveolitis, and pulmonary fibrosis have been reported.


Dermatologic effects including rash (8%) and pruritus (8%) have been reported.

A case of diffuse erythematous skin rash that progressed to an extensive full body desquamative skin rash has been reported. Even though temozolomide was permanently discontinued, the patient continued to experience the rash on a long-term basis with periodic exacerbations.


Psychiatric effects including anxiety (7%) and depression (6%) have been reported.


Metabolic effects including weight gain (5%) have been reported.


Musculoskeletal effects including myalgia (5%) have been reported.


Ocular effects including diplopia (5%) and abnormal vision (5%) have been reported.


Immunologic side effects including rare cases of opportunistic infections such as Pneumocystis carinii pneumonia have been reported.


Oncologic side effects such as very rare cases of myelodysplastic syndrome and secondary malignancies, including leukemia and newly diagnosed glioblastoma multiforme have been reported.


Hematologic side effects have been reported very rarely including prolonged pancytopenia (which may result in aplastic anemia).


Postmarketing hepatic side effects have included elevated liver enzymes, hyperbillirubinemia, cholestasis, and hepatitis.

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