Topotecan Side Effects

It is possible that some side effects of topotecan may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

For the Consumer

Applies to topotecan: oral capsule

As well as its needed effects, topotecan may cause unwanted side effects that require medical attention.

If any of the following side effects occur while taking topotecan, check with your doctor immediately:

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 topotecan side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned 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

General

The most common adverse events were hematologic: neutropenia, leukopenia, anemia, and thrombocytopenia.

Hematologic

Very common (10% or more): Neutropenia (up to 97%), leukopenia (97%), anemia (up to 94%), thrombocytopenia (up to 74%), pyrexia/grade 4 neutropenia (28%), febrile neutropenia (28%), hemorrhage (15%)
Common (1% to 10%): Pancytopenia, coagulation adverse event
Postmarketing reports: Severe bleeding (in association with thrombocytopenia)

Gastrointestinal

Very common (10% or more): Nausea (64%), other gastrointestinal adverse event (63%), vomiting (45%), diarrhea (32%), constipation (29%), abdominal pain (22%), stomatitis (18%)
Common (1% to 10%): Abdominal pain, intestinal obstruction, dyspepsia
Frequency not reported: Neutropenic colitis
Postmarketing reports: Abdominal pain potentially associated with neutropenic colitis

Dermatologic

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

Very common (10% or more): Alopecia (49%), dermatologic adverse reaction (48%), rash (16%)
Common (1% to 10%): Pruritus
Frequency not reported: Urticaria
Postmarketing reports: Angioedema, severe dermatitis, severe pruritus

Immunologic

Very common (10% or more): Sepsis or pyrexia/infection with neutropenia (43%), infection-febrile neutropenia (28%), infection (27%)
Common (1% to 10%): Pneumonia, allergy-immunology adverse event, pharyngitis, rhinitis, sepsis

Other

Pain includes abdominal pain or cramping, arthralgia, bone pain, chest pain (non-cardiac and non-pleuritic), dysmenorrhea, dyspareunia, earache, headache, hepatic pain, myalgia, neuropathic pain, pain due to radiation, pelvic pain, pleuritic pain, rectal or perirectal pain, tumor pain, body pain, back pain, and skeletal pain.
"Constitutional" is a composite term that includes fatigue (lethargy, malaise, asthenia), fever (in the absence of neutropenia), rigors, chills, sweating, and weight gain or loss.

Very common (10% or more): Constitutional (69%), pain (up to 59%), fatigue (29%), pyrexia (28%), asthenia (25%), mucositis (14%)
Common (1% to 10%): Treatment related death, malaise

Respiratory

Very common (10% or more): Dyspnea (22%), pulmonary adverse event (17%), coughing (15%)
Common (1% to 10%): Epistaxis, respiratory disorder
Rare (less than 0.1%): Interstitial lung disease
Postmarketing reports: Fatal interstitial lung disease

Hepatic

Very common (10% or more): Hepatic adverse event (24%)
Common (1% to 10%): Transient elevations in hepatic enzymes, hyperbilirubinemia, elevated ALT, elevated AST

Nervous system

Very common (10% or more): Non-neuropathy neurologic adverse event (35%), headache (18%)
Common (1% to 10%): Paresthesia, neuropathy, dizziness
Uncommon (0.1% to 1%): Hypoesthesia, peripheral neuropathy, paresis

Cardiovascular

Very common (10% or more): Cardiovascular adverse event (25%)

Metabolic

Very common (10% or more): Metabolic-laboratory adverse event (39%), anorexia (19%)
Frequency not reported: Dehydration

Musculoskeletal

Very common (10% or more): Musculoskeletal adverse event (14%)

Hypersensitivity

Common (1% to 10%): Hypersensitivity (including rash)
Postmarketing reports: Allergic manifestations, anaphylactoid reactions

Genitourinary

Very common (10% or more): Genitourinary adverse event (36%)
Common (1% to 10%): Sexual reproduction function adverse event

Local

Rare (less than 0.1%): Extravasation
Postmarketing reports: Inadvertent extravasation

Endocrine

Common (1% to 10%): Endocrine adverse event

Ocular

Common (1% to 10%): Ocular-visual adverse event

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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