Topotecan Side Effects

Some side effects of topotecan may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to topotecan: oral capsule

Along with its needed effects, topotecan 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 topotecan:

More common
  • Black, tarry stools
  • bleeding gums
  • blood in the urine or stools
  • chest pain
  • chills
  • cough
  • fever
  • lower back or side pain
  • 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

Some side effects of topotecan 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
  • Diarrhea
  • hair loss or thinning of the hair
  • lack or loss of strength
  • loss of appetite
  • nausea
  • vomiting
  • weight loss

For Healthcare Professionals

Applies to topotecan: intravenous powder for injection, intravenous solution, oral capsule


Use of granulocyte colony stimulating factor (G-CSF) may be useful. Alternatively, dose reductions could be considered, especially if topotecan is used for palliative effects.

Risk of myelosuppression is increased in cases of pretreatment chemotherapy and/or radiation therapy.

Hematologic side effects have been the most profound and dose-limiting toxicity. Virtually all patients have developed neutropenia (80% to 98% less than 1,500/mm3), leukopenia (98% less than 3,000/mm3), anemia (85% to 95% less than 10 g/dL), and thrombocytopenia (44% to 63% less than 100,000/mm3). Twenty-five percent to 80% of patients developed severe pancytopenia. Nadirs have typically been observed 8 to 15 days after administration, with recovery often noted by day 21. During postmarketing use of topotecan, severe bleeding in association with thrombocytopenia has been reported.


Gastrointestinal side effects have been reported to usually be mild to moderate in severity, observed seven to fourteen days after administration, and last for two to five days. Protracted cases of nausea, vomiting, or diarrhea have been reported infrequently. However, these data are from studies where antiemetic therapy was not routinely used, and effective antiemetic therapy is now available.

Abdominal pain potentially associated with neutropenic colitis has been reported.

Gastrointestinal side effects have been common, but rarely severe, and can usually be controlled with antiemetic therapy. Gastrointestinal side effects have included nausea (64%), vomiting (45%), diarrhea (32%), constipation (29%), abdominal pain (22%), stomatitis (18%), and anorexia (19%). Postmarketing reports of abdominal pain may potentially be associated with neutropenic colitis.


Pain includes body pain, back pain, an skeletal pain.

General side effects have included fatigue (29%), fever (28%), pain (23%), and asthenia (25%).


Dermatologic side effects have included alopecia (49%) and rash (16%). During postmarketing use of topotecan, angioedema, severe dermatitis and severe pruritus have been reported.

Rash also includes pruritus, rash erythematous, urticaria, dermatitis, bullous eruption, and rash maculopapular.


Some of the reports of interstitial lung disease have been fatalities.

Respiratory side effects have included dyspnea (22%), coughing (15%), and interstitial lung disease. A case of bronchiolitis has also been reported.

Nervous system

Nervous system side effects have included headache (18%).


Musculoskeletal side effects have included arthralgias and myalgias.


Genitourinary side effects have been limited to rare cases of acute renal failure, microscopic hematuria, proteinuria, and dysuria.

Cases of acute renal failure have been associated with myelosuppression and sepsis. They are not necessarily directly caused by topotecan therapy.


Hypersensitivity reactions have included anaphylactoid reactions, angioedema, severe dermatitis, and severe pruritus.


Local side effects including erythema and bruising have resulted from inadvertent extravasation.

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