Temozolomide Side Effects

Medically reviewed by Drugs.com. Last updated on Oct 16, 2024.

Applies to temozolomide: oral capsule.

Other dosage forms:

• intravenous powder for solution

Common side effects of temozolomide

Some side effects of temozolomide may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common side effects

• constipation

Less common or rare side effects

• 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

Serious side effects of temozolomide

Along with its needed effects, temozolomide may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking temozolomide:

Less common or rare side effects

• amnesia
• black, tarry stools
• blood in the urine or stools
• 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
• seizures
• swelling of the feet or lower legs
• unusual bleeding or bruising

Incidence not known

• blistering, peeling, or loosening of the skin
• chest pain or tightness
• clay colored stools
• cough
• decreased appetite
• diarrhea
• difficulty with 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
• stomach pain or tenderness
• trouble breathing
• unusual tiredness or weakness
• yellow skin or eyes

For healthcare professionals

Applies to temozolomide: intravenous powder for injection, oral capsule.

General adverse events

The most common side effects were alopecia, nausea, vomiting, anorexia, headache, and constipation.^[Ref]

Gastrointestinal

• Very common (10% or more): Constipation (Up to 33%), nausea (Up to 53%), vomiting (Up to 42%), diarrhea (16%)
• Common (1% to 10%): Abdominal pain, diarrhea, stomatitis, taste perversion, dysphagia, dyspepsia
• Uncommon (0.1% to 1%): Abdominal distension, fecal incontinence, gastrointestinal disorder, gastroenteritis, hemorrhoids^[Ref]

Nervous system

• Very common (10% or more): Headache (Up to 41%), convulsions (Up to 23%), hemiparesis (18%), abnormal coordination (11%)
• Common (1% to 10%): Dizziness, confusion, memory impairment, amnesia, paresthesia, somnolence, paresis, urinary incontinence, ataxia, abnormal gait, neuropathy, balance impairment, speech disorder, tremors, hemiparesis^[Ref]

Cardiovascular

• Very common (10% or more): Peripheral edema (11%)
• Uncommon (0.1% to 1%): Palpitation^[Ref]

Other

• Very common (10% or more): Fatigue (Up to 61%), asthenia (13%), fever (13%)
• Common (1% to 10%): Weakness, radiation injury, face edema, pain, hearing impairment
• Uncommon (0.1% to 1%): Otitis media, tinnitus, hyperacusis, earache, deafness, vertigo, impotence, vaginal hemorrhage, menorrhagia, amenorrhea, vaginitis, breast pain^[Ref]

Endocrine

• Common (1% to 10%): Adrenal hypercorticism^[Ref]

Respiratory

• Common (1% to 10%): Cough, dyspnea, upper respiratory tract infection, pharyngitis, sinusitis

Post-marketing surveillance: Interstitial pneumonitis, pneumonitis, alveolitis, pulmonary fibrosis^[Ref]

Dermatologic

• Very common (10% or more): Alopecia (55 to 69%), rash (13 to 19%)
• Common (1% to 10%): Dry skin, erythema, pruritus, petechiae
• Uncommon (0.1% to 1%): Photosensitivity reaction, abnormal pigmentation, sweating increased

Post-marketing surveillance: Toxic epidermal necrolysis, Stevens-Johnson syndrome^[Ref]

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.^[Ref]

Psychiatric

• Common (1% to 10%): Insomnia, anxiety, depression
• Uncommon (0.1% to 1%): Agitation, apathy, behavior disorder, hallucination, amnesia^[Ref]

Metabolic

• Very common (10% or more): Anorexia (19 to 27%)
• Common (1% to 10%): Weight increase, weight decrease, hyperglycemia
• Uncommon (0.1% to 1%): Hypokalemia^[Ref]

Musculoskeletal

• Common (1% to 10%): Arthralgia, back pain^[Ref]

Ocular

• Common (1% to 10%): Vision blurred, diplopia
• Uncommon (0.1% to 1%): Hemianopia, visual acuity reduced, vision disorder, visual field defect, eye pain, dry eyes^[Ref]

Immunologic

• Common (1% to 10%): Infection, Herpes simplex, wound infection, candidiasis oral
• Uncommon (0.1% to 1%): Herpes zoster, influenza-like symptoms

Post-marketing surveillance: Opportunistic infections including Pneumocystis pneumonia^[Ref]

Oncologic

Post-marketing surveillance: Secondary malignancies including myeloid leukemia^[Ref]

Hematologic

• Common (1% to 10%): Thrombocytopenia, hemorrhage, leukopenia, neutropenia, lymphopenia, febrile neutropenia, anemia

Post-marketing surveillance: Prolonged pancytopenia, myelodysplastic syndrome^[Ref]

Hepatic

• Common (1% to 10%): ALT increased
• Uncommon (0.1% to 1%): Hepatic enzymes increased, Gamma GT increased, AST increased

Post-marketing surveillance: Fatal and severe hepatotoxicity, elevation of liver enzymes, hyperbilirubinemia, cholestasis, hepatitis

Hypersensitivity

• Common (1% to 10%): Allergic reaction

Renal

• Common (1% to 10%): Urinary tract infection, micturition increased frequency
• Uncommon (0.1% to 1%): Dysuria

Further information

Temozolomide side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

Medical Disclaimer