Summary

Commonly reported side effects of temozolomide include: leukopenia. Other side effects include: decreased hemoglobin. Continue reading for a comprehensive list of adverse effects.

Applies to temozolomide: oral capsule. Other dosage forms:

• intravenous powder for solution

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

• 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 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
• tightness in the chest
• troubled breathing
• unusual tiredness or weakness
• yellow skin or eyes

Other 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

• 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

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]

General

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