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Hycamtin Side Effects

Generic Name: topotecan

Note: This page contains information about the side effects of topotecan. Some of the dosage forms included on this document may not apply to the brand name Hycamtin.

In Summary

Common side effects of Hycamtin include: febrile neutropenia, sepsis, infection, abdominal pain, alopecia, anemia, asthenia, constipation, dyspnea, fatigue, fever, headache, leukopenia, nausea, neutropenia, stomatitis, thrombocytopenia, vomiting, granulocytopenia, diarrhea, and anorexia. Other side effects include: febrile neutropenia, increased serum alanine aminotransferase, increased serum aspartate aminotransferase, intestinal obstruction, pain, and paresthesia. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to topotecan: oral capsule

In addition to its needed effects, some unwanted effects may be caused by topotecan (the active ingredient contained in Hycamtin). In the event that any of these side effects do occur, they may require medical attention.

Major Side Effects

You should check with your doctor immediately if any of these side effects occur when 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

Minor Side Effects

Some of the side effects that can occur with topotecan may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

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


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


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)[Ref]


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[Ref]


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

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[Ref]


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


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


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[Ref]


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

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[Ref]


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


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


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


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


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


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


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


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


1. Lilenbaum RC, Ratain MJ, Miller AA, Hargis JB, Hollis DR, Rosner GL, O'Brien SM, Brewster L, Green MR, Schilsky RL "Phase I study of paclitaxel and topotecan in patients with advanced tumors: a cancer and leukemia group B study." J Clin Oncol 13 (1995): 2230-7

2. Betcher DL, Burnham N "Topotecan." J Pediatr Oncol Nurs 9 (1992): 31-2

3. Hochster H, Liebes L, Speyer J, Sorich J, Taubes B, Oratz R, Wernz J, Chachoua A, Raphael B, Vinci RZ, et al "Phase I trial of low-dose continuous topotecan infusion in patients with cancer: an active and well-tolerated regimen." J Clin Oncol 12 (1994): 553-9

4. Eckardt J, Burris H, Kuhn J, Smith S, Rodriguez G, Weiss G, Smith L, Shaffer D, Johnson R, Von Hoff D "PHASE I AND PHARMACOKINETIC TRIAL OF CONTINUOUS INFUSION TOPOTECAN IN PATIENTS WITH REFRACTORY SOLID TUMORS (MEETING ABSTRACT)." Proc Annu Meet Am Soc Clin Oncol 11 (1992): a3731992

5. Saltz L, Sirott M, Young C, et al. "Phase I clinical and pharmacology study of topotecan given daily for 5 consecutive days to patients with advanced solid tumors, with attempt at dose intensification using recombinant granulocyte colony-stimulating factor." J Natl Cancer Inst 85 (1993): 1499-507

6. Sabiers JH, Berger NA, Berger SJ, Haaga JR, Hoppel CL, Willson JK "Phase I trial of topotecan administered as a 72-hr infusion (Meeting abstract)." Proc Annu Meet Am Assoc Cancer Res 34 (1993): a25411993

7. Kantarjian HM, Beran M, Ellis A, Zwelling L, O'Brien S, Cazenave L, Koller C, Rios MB, Plunkett W, Keating MJ, et al "Phase I study of Topotecan, a new topoisomerase I inhibitor, in patients with refractory or relapsed acute leukemia." Blood 81 (1993): 1146-51

8. "Product Information. Hycamtin (topotecan)." SmithKline Beecham, Philadelphia, PA.

9. van Warmerdam LJ, ten Bokkel Huinink WW, Rodenhuis S, Koier I, Davies BE, Rosing H, Maes RA, Beijnen JH "Phase I clinical and pharmacokinetic study of topotecan administered by a 24-hour continuous infusion." J Clin Oncol 13 (1995): 1768-76

10. Stewart CF, Baker SD, Heideman RL, Jones D, Crom WR, Pratt CB "Clinical pharmacodynamics of continuous infusion topotecan in children: systemic exposure predicts hematologic toxicity." J Clin Oncol 12 (1994): 1946-54

11. Wall J, Burris H, Rodriguez G, Brown T, Weiss G, Kuhn J, Brown J, Johnson R, Friedman C, Mann W, et al "PHASE I TRIAL OF TOPOTECAN (SK AND F 104864) IN PATIENTS WITH REFRACTORY SOLID TUMORS (MEETING ABSTRACT)." Proc Annu Meet Am Soc Clin Oncol 10 (1991): a2611991

12. Janik J, Miller L, Smith J, Kopp W, Alvord G, Gause B, Curti B, Urba WJ, Longo DL "Prechemotherapy granulocyte-macrophage colony stimulating factor (GM- CSF) prevents topotecan-induced neutropenia (Meeting abstract)." Proc Annu Meet Am Soc Clin Oncol 12 (1993): a15071993

13. Miller AA, Hargis JB, Lilenbaum RC, Fields SZ, Rosner GL, Schilsky RL "Phase I study of topotecan and cisplatin in patients with advanced solid tumors: a cancer and leukemia group B study." J Clin Oncol 12 (1994): 2743-50

14. Rowinsky EK, Grochow LB, Hendricks CB, Ettinger DS, Forastiere AA, Hurowitz LA, McGuire WP, Sartorius SE, Lubejko BG, Kaufmann SH, et al "Phase I and pharmacologic study of topotecan: a novel topoisomerase I inhibitor." J Clin Oncol 10 (1992): 647-56

15. Pratt CB, Stewart C, Santana VM, Bowman L, Furman W, Ochs J, Marina N, Kuttesch JF, Heideman R, Sandlund JT, et al "Phase I study of topotecan for pediatric patients with malignant solid tumors." J Clin Oncol 12 (1994): 539-43

16. Haas NB, LaCreta FP, Walczak J, Hudes GR, Brennan J, Ozols RF, O'Dwyer PJ "PHASE I/PHARMACOKINETIC TRIAL OF TOPOTECAN ON A WEEKLY 24-HOUR INFUSION SCHEDULE (MEETING ABSTRACT)." Proc Annu Meet Am Assoc Cancer Res 33 (1992): a31281992

17. O'Brien S, Kantarjian H, Ellis A, Zwelling L, Estey E, Keating M "Topotecan in chronic lymphocytic leukemia." Cancer 75 (1995): 1104-8

18. Rowinsky EK, Adjei A, Donehower RC, Gore SD, Jones RJ, Burke PJ, Cheng YC, Grochow LB, Kaufmann SH "Phase I and pharmacodynamic study of the topoisomerase I-inhibitor topotecan in patients with refractory acute leukemia." J Clin Oncol 12 (1994): 2193-203

19. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

20. Edgerton CC, Gilman M, Roth BJ "Topotecan-induced bronchiolitis." South Med J 97 (2004): 699-701

Not all side effects for Hycamtin may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

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. 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.