Temodar Side Effects

Generic Name: temozolomide

Please note - some side effects for Temodar may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Temodar - for the Consumer

Temodar

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 Temodar:

Anxiety; back pain; breast pain; constipation; cough; diarrhea; dizziness; drowsiness; dry skin; hair loss; headache; joint pain; loss of appetite; mouth sores; muscle aches; nausea; stomach pain; 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 or painful urination; fever, chills, or sore throat; loss of bladder control; loss of coordination; memory loss; muscle pain or weakness; numbness and tingling; pain, irritation, itching, warmth, swelling, or redness at the injection site; paralysis; persistent cough; red, swollen, peeling, or blistered skin; seizures; severe or persistent headache, nausea, or vomiting; severe tiredness or weakness; shortness of breath; speech changes; sudden or unusual weight gain; swelling of the ankles, feet, or hands; unusual bruising or bleeding; trouble walking; vision changes (eg, blurred vision, double vision).

Temodar Side Effects - for the Professional

Temodar

• The most common adverse reactions (≥10% incidence) are: alopecia, fatigue, nausea, vomiting, headache, constipation, anorexia, convulsions, rash, hemiparesis, diarrhea, asthenia, fever, dizziness, coordination abnormal, viral infection, amnesia, and insomnia. (6.1)
• The most common Grade 3 to 4 hematologic laboratory abnormalities (≥10% incidence) that have developed during treatment with temozolomide are: lymphopenia, thrombocytopenia, neutropenia, and leukopenia. (6.1)
• Allergic reactions have also been reported. (6)

Side Effects by Body System

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.

Dermatologic

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

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).

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