Note: This document contains side effect information about etoposide. Some dosage forms listed on this page may not apply to the brand name Toposar.

Applies to etoposide: oral capsule liquid filled. Other dosage forms:

• intravenous powder for solution, intravenous solution

Serious side effects of Toposar

Along with its needed effects, etoposide (the active ingredient contained in Toposar) 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 etoposide:

More common

• Black, tarry stools
• bleeding gums
• blood in the urine or stools
• chest pain
• chills
• cough
• fever
• painful or difficult urination
• pale skin
• pinpoint red spots on the skin
• shortness of breath
• sore throat
• sores, ulcers, or white spots on the lips or in the mouth
• swollen glands
• troubled breathing with exertion
• unusual bleeding or bruising
• unusual tiredness or weakness

Less common

• Blurred vision
• confusion
• cough
• difficulty with swallowing
• dizziness
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• fast heartbeat
• feeling of warmth
• headache
• hives
• itching
• nervousness
• numbness or tingling in the fingers or toes
• pounding in the ears
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• redness of the face, neck, arms, and occasionally, upper chest
• skin rash
• slow or fast heartbeat
• sweating
• tightness in the chest
• wheezing

Rare

• Bone pain

Incidence not known

• Abdominal or stomach pain, severe
• blistering, peeling, or loosening of the skin
• cough or hoarseness
• dark urine
• diarrhea
• difficult breathing
• drowsiness
• joint or muscle pain
• loss of appetite
• lower back or side pain
• muscle tremors
• nausea or vomiting
• rapid, deep breathing
• red, irritated eyes
• red skin lesions, often with a purple center
• restlessness
• seizures
• stomach cramps
• yellow eyes or skin

Other side effects of Toposar

Some side effects of etoposide 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

• Hair loss or thinning of the hair
• swelling or inflammation of the mouth
• weight loss

Incidence not known

• Bad, unusual, or unpleasant (after) taste
• change in taste
• constipation
• cracked lips
• general feeling of discomfort or illness
• heartburn
• lack or loss of strength
• pain or burning in the throat
• sleepiness or unusual drowsiness

For Healthcare Professionals

Applies to etoposide: intravenous powder for injection, intravenous solution, oral capsule.

Hematologic

Very common (10% or more): Myelosuppression (sometimes fatal), leukopenia, thrombocytopenia, neutropenia, anemia^[Ref]

Gastrointestinal

Very common (10% or more): Abdominal pain, constipation, nausea, vomiting, anorexia, mucositis (including stomatitis and esophagitis)

Common (1% to 10%): Diarrhea

Rare (less than 0.1%): Dysphagia, dysgeusia^[Ref]

Cardiovascular

Common (1% to 10%): Myocardial infarction, arrhythmia, transient systolic hypotension (following rapid IV administration), hypertension

Uncommon (0.1% to 1%): Cyanosis

Rare (less than 0.1%): Heart failure^[Ref]

Hypersensitivity

Common (1% to 10%): Anaphylaxis (sometimes fatal)^[Ref]

Dermatologic

Very common (10% or more): Alopecia, pigmentation

Common (1% to 10%): Rash, urticaria, pruritus

Rare (less than 0.1%): Stevens-Johnson syndrome, toxic epidermal necrolysis, radiation recall dermatitis, maculopapular rash^[Ref]

Hepatic

Common (1% to 10%): Hepatotoxicity^[Ref]

Other

Very common (10% or more): Asthenia, malaise

Frequency not reported: Fever^[Ref]

Respiratory

Rare (less than 0.1%): Pulmonary fibrosis, interstitial pneumonitis, bronchospasm, dyspnea^[Ref]

Immunologic

Frequency not reported: Infectious complications^[Ref]

Metabolic

Frequency not reported: Tumor lysis syndrome (sometimes fatal) has been reported following the use of this drug in association with other chemotherapeutic drugs^[Ref]

Nervous system

Very common (10% or more: Neurotoxicity (e.g., somnolence, fatigue)

Common (1% to 10%): Dizziness

Uncommon (0.1% to 1%): Peripheral neuropathy

Rare (less than 0.1%): Seizure (occasionally associated with allergic reactions), optic neuritis, cortical blindness transient, neurotoxicity (e.g., somnolence, fatigue)

Frequency not reported: Aftertaste^[Ref]

Ocular

Rare (0.01% to 0.1%): Optic neuritis, transient cortical blindness^[Ref]

Local

Common (1% to 10%): Extravasation (e.g., local soft tissue toxicity, swelling, pain, cellulitis, necrosis including skin necrosis), phlebitis

Oncologic

Common (1% to 10%): Acute leukemia

Frequency not reported: Acute promyelocytic leukemia^[Ref]