Temozolomide Side Effects

Some side effects of temozolomide may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to temozolomide: oral capsule

Get emergency medical help if you have any of these signs of an allergic reaction while taking temozolomide: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

• seizure (convulsions);

• numbness or tingling on one side of your body;

• signs of infection such as fever, chills, sore throat, flu symptoms, easy bruising or bleeding (nosebleeds, bleeding gums), loss of appetite, nausea and vomiting, unusual weakness;

• dry cough, feeling short of breath, weight loss, night sweats;

• pain or burning when you urinate;

• white patches or sores inside your mouth or on your lips; or

• nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects of temozolomide may include:

• hair loss;

• tired feeling;

• diarrhea, constipation;

• mild skin rash;

• dizziness, blurred vision;

• sleep problems (insomnia); or

• unusual or unpleasant taste in your mouth.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to temozolomide: intravenous powder for injection, oral capsule

Gastrointestinal

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

General

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

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

Other

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

Endocrine

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

Genitourinary

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

Respiratory

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

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

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

Metabolic

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

Musculoskeletal

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

Ocular

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

Immunologic

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

Oncologic

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

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

Hepatic

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

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