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Hycamtin (Topotecan) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Hycamtin (Topotecan) and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.

Reports by Event Outcome

All Cases (157)
Death (52)
Life Threatening Events (11)
Disability (10)

Reports by Reaction Type

White Blood Cell Count Decreased (37)Neutrophil Count Decreased (34)Platelet Count Decreased (32)Anaemia (28)Death (24)RED Blood Cell Count Decreased (21)Nausea (13)Decreased Appetite (11)Febrile Neutropenia (11)Fatigue (10)Interstitial Lung Disease (8)Blood Creatinine Increased (8)

Below are a few examples of reports where side effects / adverse reactions may be related to Hycamtin (Topotecan). For a complete list or a specific selection of reports, please use the links above.

Possible Hycamtin side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: male

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Hycamtin



Possible Hycamtin side effects in 50 year old female

Reported by a health professional (non-physician/pharmacist) from Japan on 2012-08-24

Patient: 50 year old female, weighing 62.5 kg (137.5 pounds)

Reactions: Blood Alkaline Phosphatase Increased, White Blood Cell Count Decreased, Pain of Skin, Anaemia, Alanine Aminotransferase Increased, Gamma-Glutamyltransferase Increased, Aspartate Aminotransferase Increased, Platelet Count Decreased, Blood Creatinine Increased, Neutrophil Count Decreased

Drug(s) suspected as cause:
Hycamtin

Other drugs received by patient: Dexamethasone Sodium Phosphate; Granisetron



Possible Hycamtin side effects in 51 year old female

Reported by a health professional (non-physician/pharmacist) from Japan on 2012-08-13

Patient: 51 year old female

Reactions: White Blood Cell Count Decreased, RED Blood Cell Count Decreased, Nausea, Anaemia, Platelet Count Decreased, Headache, Neutrophil Count Decreased, Decreased Appetite

Drug(s) suspected as cause:
Hycamtin
    Dosage: 1mgm2 per day
    Start date: 2011-12-19
    End date: 2012-02-03

Hycamtin
    Dosage: 1.25mgm2 per day
    Indication: Ovarian Cancer Recurrent
    Start date: 2011-11-28
    End date: 2011-12-02



Possible Hycamtin side effects in 68 year old female

Reported by a health professional (non-physician/pharmacist) from Japan on 2012-08-13

Patient: 68 year old female, weighing 38.0 kg (83.6 pounds)

Reactions: White Blood Cell Count Decreased, C-Reactive Protein Increased, RED Blood Cell Count Decreased, Nausea, Anaemia, Neutrophil Count Decreased, Decreased Appetite

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Hycamtin

Other drugs received by patient: Decadron Phosphate; Clindamycin HCL; Zithromax; Rocephin; Minocycline HCL; Gran; Doripenem; Levofloxacin; Fosmicin S; Kytril



Possible Hycamtin side effects in 70 year old female

Reported by a physician from Japan on 2012-08-13

Patient: 70 year old female, weighing 45.0 kg (99.0 pounds)

Reactions: Hepatic Function Abnormal, Neutropenia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Hycamtin

Other drugs received by patient: Decadron Phosphate; Heparin Sodium; Urso 250



Possible Hycamtin side effects in

Reported by a physician from Greece on 2012-08-09

Patient:

Reactions: Off Label Use, Neuropathy Peripheral

Drug(s) suspected as cause:
Doxorubicin Hydrochloride
    Dosage: on day 4; every 28 days
    Indication: Pleural Mesothelioma Malignant

Hycamtin
    Dosage: days 1-3; every 28 days
    Indication: Pleural Mesothelioma Malignant

Other drugs received by patient: Opiates; Anti-Inflammatory Drugs; Bronchodilator, NOS; Antiemetic



Possible Hycamtin side effects in 68 year old female

Reported by a health professional (non-physician/pharmacist) from Japan on 2012-08-09

Patient: 68 year old female, weighing 38.0 kg (83.6 pounds)

Reactions: White Blood Cell Count Decreased, RED Blood Cell Count Decreased, Nausea, C-Reactive Protein Increased, Anaemia, Neutrophil Count Decreased, Decreased Appetite

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Hycamtin

Other drugs received by patient: Kytril; Zithromax; Minocycline HCL; Levofloxacin; Rocephin; Doripenem; Clindamycin HCL; Fosmicin S; Decadron Phosphate; Gran



Possible Hycamtin side effects in female

Reported by a physician from Japan on 2012-08-09

Patient: female, weighing 46.0 kg (101.2 pounds)

Reactions: C-Reactive Protein Increased, Anaemia, Platelet Count Decreased, Neutrophil Count Decreased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Hycamtin

Other drugs received by patient: Transfusion; Paclitaxel; Gemcitabine Hydrochloride; Carboplatin



Possible Hycamtin side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-08

Patient: male

Reactions: Hospitalisation

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Hycamtin



Possible Hycamtin side effects in 61 year old female

Reported by a consumer/non-health professional from United States on 2012-08-02

Patient: 61 year old female

Reactions: Dehydration

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Hycamtin

Other drugs received by patient: Hydrochlorothiazide



Possible Hycamtin side effects in 80 year old female

Reported by a physician from Japan on 2012-08-01

Patient: 80 year old female, weighing 68.0 kg (149.6 pounds)

Reactions: White Blood Cell Count Decreased, Blood Urea Increased, RED Blood Cell Count Decreased, Anaemia, Platelet Count Decreased, Blood Creatinine Increased, Neutrophil Count Decreased

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Hycamtin
    Dosage: .75mgm2 per day
    Indication: Ovarian Cancer Recurrent
    Start date: 2012-04-24
    End date: 2012-04-28

Hycamtin
    Dosage: .5mgm2 per day
    Start date: 2012-05-22
    End date: 2012-05-26

Other drugs received by patient: Dexamethasone Sodium Phosphate; Granisetron



Possible Hycamtin side effects in 62 year old male

Reported by a consumer/non-health professional from United States on 2012-07-31

Patient: 62 year old male

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Hycamtin

Other drugs received by patient: Zofran; Calcium; Klor-CON; Morphine Sulfate; Aspirin; Fluoxetine HCL; Fentanyl Citrate; Furosemide; Isosorbide; Magnesium; Metformin Hydrochloride; Pravastatin; Plavix; Miralax; Lisinopril; Gabapentin; Fenofibrate



Possible Hycamtin side effects in 57 year old male

Reported by a consumer/non-health professional from United States on 2012-07-27

Patient: 57 year old male

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Hycamtin



Possible Hycamtin side effects in 51 year old male

Reported by a consumer/non-health professional from United States on 2012-07-27

Patient: 51 year old male

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Hycamtin



Possible Hycamtin side effects in 77 year old female

Reported by a physician from Japan on 2012-07-25

Patient: 77 year old female, weighing 46.0 kg (101.2 pounds)

Reactions: Diarrhoea, Dizziness, Headache, Blood Sodium Decreased

Drug(s) suspected as cause:
Hycamtin



Possible Hycamtin side effects in male

Reported by a consumer/non-health professional from United States on 2012-07-24

Patient: male

Reactions: Hospitalisation

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Hycamtin



Possible Hycamtin side effects in female

Reported by a physician from Japan on 2012-07-23

Patient: female, weighing 50.0 kg (110.0 pounds)

Reactions: Dysgeusia, Platelet Count Decreased, Neutrophil Count Decreased

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Hycamtin



Possible Hycamtin side effects in 80 year old female

Reported by a physician from Japan on 2012-07-16

Patient: 80 year old female, weighing 68.0 kg (149.6 pounds)

Reactions: White Blood Cell Count Decreased, Blood Urea Increased, RED Blood Cell Count Decreased, Anaemia, Platelet Count Decreased, Blood Creatinine Increased, Neutrophil Count Decreased

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Hycamtin
    Dosage: .75mgm2 per day
    Indication: Ovarian Cancer Recurrent
    Start date: 2012-04-24
    End date: 2012-04-28

Hycamtin
    Dosage: .5mgm2 per day
    Start date: 2012-05-22
    End date: 2012-05-26

Other drugs received by patient: Granisetron; Dexamethasone Sodium Phosphate



Possible Hycamtin side effects in 57 year old female

Reported by a health professional (non-physician/pharmacist) from Japan on 2012-07-12

Patient: 57 year old female

Reactions: White Blood Cell Count Decreased, RED Blood Cell Count Decreased, Anaemia, Platelet Count Decreased, Abdominal Distension, Neutrophil Count Decreased, Constipation

Drug(s) suspected as cause:
Hycamtin



Possible Hycamtin side effects in 63 year old female

Reported by a health professional (non-physician/pharmacist) from Japan on 2012-07-11

Patient: 63 year old female

Reactions: White Blood Cell Count Decreased, Blood Urea Increased, Nausea, Anaemia, Fatigue, RED Blood Cell Count Decreased, Neutrophil Count Decreased, Decreased Appetite

Drug(s) suspected as cause:
Hycamtin



Possible Hycamtin side effects in 56 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-11

Patient: 56 year old male, weighing 67.3 kg (148.1 pounds)

Reactions: Small Cell Lung Cancer Metastatic

Adverse event resulted in: death

Drug(s) suspected as cause:
Hycamtin

Other drugs received by patient: Lortab; Procrit; Xanax; Morphine Sulfate



Possible Hycamtin side effects in female

Reported by a health professional (non-physician/pharmacist) from Japan on 2012-07-10

Patient: female

Reactions: Interstitial Lung Disease, Pancytopenia, Febrile Neutropenia

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Hycamtin

Other drugs received by patient: Neutrogin; Dexamethasone Sodium Phosphate; Maxipime; Loxoprofen Sodium; Famotidine; Seltouch



Possible Hycamtin side effects in 68 year old female

Reported by a health professional (non-physician/pharmacist) from Japan on 2012-07-10

Patient: 68 year old female, weighing 38.0 kg (83.6 pounds)

Reactions: White Blood Cell Count Decreased, RED Blood Cell Count Decreased, C-Reactive Protein Increased, Nausea, Anaemia, Neutrophil Count Decreased, Decreased Appetite

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Hycamtin

Other drugs received by patient: Doripenem; Gran; Decadron; Minocycline HCL; Levofloxacin; Zithromax; Fosmicin S; Kytril; Rocephin; Clindamycin HCL



Possible Hycamtin side effects in 71 year old female

Reported by a health professional (non-physician/pharmacist) from Japan on 2012-07-10

Patient: 71 year old female

Reactions: Cholestasis

Drug(s) suspected as cause:
Hycamtin



Possible Hycamtin side effects in male

Reported by a consumer/non-health professional from United States on 2012-07-06

Patient: male

Reactions: Fatigue, Pneumonia, Haemorrhage, Hypotension, Blood Glucose Increased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Hycamtin



Possible Hycamtin side effects in 59 year old female

Reported by a physician from Japan on 2012-07-05

Patient: 59 year old female, weighing 60.6 kg (133.3 pounds)

Reactions: White Blood Cell Count Decreased, RED Blood Cell Count Decreased, Anaemia, Platelet Count Decreased, Neutrophil Count Decreased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Hycamtin

Other drugs received by patient: Lansoprazole; Decadron; Cefepime; Flurbiprofen; Sandostatin



Possible Hycamtin side effects in female

Reported by a physician from Japan on 2012-07-05

Patient: female, weighing 46.0 kg (101.2 pounds)

Reactions: C-Reactive Protein Increased, Anaemia, Platelet Count Decreased, Neutrophil Count Decreased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Hycamtin

Other drugs received by patient: Transfusion; Gemcitabine; Carboplatin; Paclitaxel



Possible Hycamtin side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-03

Patient: female

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Hycamtin



Possible Hycamtin side effects in 81 year old male

Reported by a consumer/non-health professional from United States on 2012-07-03

Patient: 81 year old male

Reactions: PRE-Existing Disease, Oral Candidiasis

Adverse event resulted in: death

Drug(s) suspected as cause:
Hycamtin



Possible Hycamtin side effects in 45 year old female

Reported by a consumer/non-health professional from United States on 2012-06-29

Patient: 45 year old female

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Hycamtin

Other drugs received by patient: Potassium Acetate; Lupron; Lortab; Keppra; Unknown

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