Temozolomide Side Effects

Brand Names: Temodar

Please note - some side effects for Temozolomide may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of Temozolomide - for the Consumer

Temozolomide

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Temozolomide:

Anxiety; back pain; breast pain; constipation; cough; diarrhea; dizziness; drowsiness; dry skin; hair loss; headache; joint pain; loss of appetite; mild stomach pain; mouth or tongue sores; muscle aches; nausea; taste changes; tiredness; trouble sleeping; vomiting; weakness; weight gain.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; confusion; coughing up blood; depression; difficulty swallowing; increased, difficult, or painful urination; fever, chills, or sore throat; loss of bladder control; loss of coordination; memory loss; muscle pain or weakness; numbness, burning, or tingling; pain, irritation, itching, warmth, swelling, or redness at the injection site; paralysis on one side of the body; persistent cough; red, swollen, peeling, or blistered skin; seizures; severe or persistent headache, nausea, or vomiting; severe or persistent tiredness or weakness; shortness of breath; small red or purple spots under the skin; speech changes; sudden or unusual weight gain; swelling of the ankles, feet, or hands; symptoms of liver problems (eg, dark urine, pale stools, persistent loss of appetite, severe stomach pain, yellowing of the skin or eyes); unusual bruising or bleeding; trouble walking; vision changes (eg, blurred vision, double vision).

Side Effects by Body System - for Healthcare Professionals

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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