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Leukine (Sargramostim) - Diarrhoea - Suspected Cause - Side Effect Reports

 
 



Index of reports > Cases with Diarrhoea (24)

Below is the selection of side effect reports (a.k.a. adverse event reports) related to Leukine (Sargramostim) where reactions include diarrhoea. The selected reports were submitted to the FDA during the sample period of about a year.

Possible Leukine side effects in 82 year old male

Reported by a consumer/non-health professional from United States on 2012-08-10

Patient: 82 year old male

Reactions: Haematochezia, Diarrhoea, Colitis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ipilimumab
    Dosage: 10 mg/kg, qd on day 1of a 21 day cycle
    Indication: Malignant Melanoma
    Start date: 2011-04-21
    End date: 2011-06-24

Leukine
    Dosage: 250 mcg, qd on days1-14 of a 21 day cycle
    Indication: Malignant Melanoma
    Start date: 2011-04-21
    End date: 2011-07-07

Other drugs received by patient: Sulfamethoprim



Possible Leukine side effects in 82 year old male

Reported by a consumer/non-health professional from United States on 2012-08-10

Patient: 82 year old male, weighing 77.3 kg (170.1 pounds)

Reactions: Haematochezia, Diarrhoea, Arthralgia, Presyncope, Colitis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ipilimumab
    Dosage: 10 mg/kg over 90 min on day 1
    Indication: Malignant Melanoma
    Start date: 2011-04-21
    End date: 2011-06-24

Leukine
    Dosage: 250 mcg, qd, on days 1-14
    Indication: Malignant Melanoma
    Start date: 2011-04-21
    End date: 2011-07-07

Other drugs received by patient: Aspirin; Doxazosin Mesylate; Preservision EYE Vitamin and Mineral Suppl.; Prednisone TAB; Doxazosin Mesylate; Prilosec; Magnesium



Possible Leukine side effects in female

Reported by a consumer/non-health professional from United States on 2012-07-23

Patient: female, weighing 57.7 kg (127.0 pounds)

Reactions: Abdominal Discomfort, Nausea, Diarrhoea, Injection Site Reaction, Urinary Tract Infection, Colitis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ipilimumab
    Dosage: unk
    Start date: 2011-08-04
    End date: 2011-08-25

Ipilimumab
    Dosage: 10 mg/kg, (day 1, q12 wks)
    Indication: Malignant Melanoma
    Start date: 2011-08-04
    End date: 2011-08-04

Ipilimumab
    Dosage: 10 mg/kg, day 1, q12wks
    Start date: 2011-12-29
    End date: 2011-12-29

Ipilimumab
    Dosage: 10 mg/kg, (days 1, q12 wks)
    Start date: 2011-08-25
    End date: 2011-08-25

Leukine
    Dosage: 250 mcg, qd (days 1-14)
    Start date: 2012-01-19
    End date: 2012-02-01

Leukine
    Dosage: 250 mcg, qd(days 1-14)
    Indication: Malignant Melanoma
    Start date: 2011-08-04
    End date: 2011-08-17

Other drugs received by patient: Klonopin; Ascorbic Acid; Wellbutrin; Extra Strength Tylenol; Clonazepam; Effexor; Multi-Vitamins; Lasix; Selenium; Difenhydramin; Aspirin; Vitamin D; Prilosec



Possible Leukine side effects in 71 year old male

Reported by a consumer/non-health professional from United States on 2012-07-23

Patient: 71 year old male, weighing 74.0 kg (162.8 pounds)

Reactions: Weight Decreased, Colitis Ulcerative, Diarrhoea, Dehydration, Muscular Weakness

Drug(s) suspected as cause:
Antineoplastic Agents
    Dosage: 10 mg/kg, once day 1 of 21 day cycle
    Indication: Malignant Melanoma
    Start date: 2011-04-22
    End date: 2011-04-22

Antineoplastic Agents
    Dosage: 10 mg/kg, once day 1 of 21 day cycle
    Start date: 2011-08-25
    End date: 2011-08-25

Antineoplastic Agents
    Dosage: 10 mg/kg, once day 1 of 21 day cycle
    Start date: 2011-09-16
    End date: 2011-09-16

Leukine
    Dosage: 250 mcg, qd days 1-14
    Indication: Malignant Melanoma
    Start date: 2011-04-22

Leukine
    Dosage: 250 mcg, unk
    End date: 2011-08-17

Leukine
    Dosage: 250 mcg, qd days 1-14
    Start date: 2011-09-16
    End date: 2011-09-29



Possible Leukine side effects in 61 year old female

Reported by a consumer/non-health professional from United States on 2012-07-13

Patient: 61 year old female, weighing 59.0 kg (129.8 pounds)

Reactions: Abdominal Pain, Nausea, Diarrhoea, Colitis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ipilimumab
    Dosage: last dose on 29jun11,no of courses: 6
    Indication: Malignant Melanoma
    Start date: 2011-04-27
    End date: 2011-06-29

Leukine
    Dosage: last dose on 10jul11,no of courses: 6
    Indication: Malignant Melanoma
    Start date: 2011-04-27
    End date: 2011-07-10



Possible Leukine side effects in 49 year old male

Reported by a consumer/non-health professional from United States on 2012-06-25

Patient: 49 year old male, weighing 92.0 kg (202.4 pounds)

Reactions: Abdominal Pain, Pruritus, Diarrhoea, Chills, Hyperhidrosis, Large Intestinal Haemorrhage

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ipilimumab
    Dosage: dose 10 mg/kg, dose last course 921 mg last date administered is 03aug2011
    Indication: Malignant Melanoma
    Start date: 2011-06-13

Leukine
    Dosage: dose: 250 mcg/day (day 1-14) last administered date is 08aug2011
    Indication: Malignant Melanoma
    Start date: 2011-06-13



Possible Leukine side effects in 61 year old male

Reported by a physician from United Kingdom on 2012-06-22

Patient: 61 year old male

Reactions: Vomiting, Pain in Extremity, Aphasia, Muscular Weakness, Pulmonary Embolism, Purpura, Lower Respiratory Tract Infection, Tremor, Fatigue, Diarrhoea

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Ima950 (Vaccines)
    Dosage: , 4.96 mg;id, , 4.96 mg;id
    Indication: Glioblastoma
    Start date: 2012-02-21
    End date: 2012-02-21

Ima950 (Vaccines)
    Dosage: , 4.96 mg;id, , 4.96 mg;id
    Indication: Glioblastoma
    Start date: 2012-01-03
    End date: 2012-01-03

Leukine
    Dosage: 75 mcg;id, 75 mcg;id
    Indication: Glioblastoma
    Start date: 2012-02-21
    End date: 2012-02-21

Leukine
    Dosage: 75 mcg;id, 75 mcg;id
    Indication: Glioblastoma
    Start date: 2012-01-03
    End date: 2012-01-03

Temozolomide
    Dosage: 200 mg;po 200 mg/m2;po
    Administration route: Oral
    Indication: Glioblastoma
    Start date: 2012-02-28
    End date: 2012-03-03

Other drugs received by patient: Omeprazole; Gliclazide; Clobazam; Levetiracetam; Dexamethasone



Possible Leukine side effects in 61 year old male

Reported by a physician from United Kingdom on 2012-04-05

Patient: 61 year old male

Reactions: Vomiting, Neutrophil Count Increased, Aphasia, Pulmonary Embolism, Purpura, Tremor, Fatigue, Diarrhoea, Asthenia, White Blood Cell Count Increased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ima950 (Vaccines)
    Dosage: 4.96 mg;id
    Indication: Glioblastoma
    Start date: 2012-01-03
    End date: 2012-01-03

Ima950 (Vaccines)
    Dosage: 4.96 mg;id
    Indication: Glioblastoma
    Start date: 2012-02-21
    End date: 2012-02-21

Leukine
    Dosage: 75 mcg;id
    Indication: Glioblastoma
    Start date: 2012-01-03
    End date: 2012-01-03

Leukine
    Dosage: 75 mcg;id
    Indication: Glioblastoma
    Start date: 2012-02-21
    End date: 2012-02-21

Temozolomide
    Dosage: 200 mg;po 200 mg/m2;po
    Administration route: Oral
    Indication: Glioblastoma
    Start date: 2012-02-28
    End date: 2012-03-03



Possible Leukine side effects in 49 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-02-29

Patient: 49 year old male, weighing 92.0 kg (202.4 pounds)

Reactions: Abdominal Pain, Pruritus, Diarrhoea, Chills, Large Intestinal Haemorrhage

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ipilimumab
    Dosage: dose 10 mg/kg, dose last course 921 mg last date administered is 03aug2011
    Indication: Malignant Melanoma
    Start date: 2011-06-13

Leukine
    Dosage: dose: 250 mcg/day (day 1-14) last administered date is 08aug2011
    Indication: Malignant Melanoma
    Start date: 2011-06-13



Possible Leukine side effects in 77 year old female

Reported by a consumer/non-health professional from United States on 2012-02-05

Patient: 77 year old female, weighing 64.0 kg (140.8 pounds)

Reactions: Large Intestine Perforation, Embolism, Diarrhoea, Colitis Ulcerative, Pseudomembranous Colitis, Platelet Count Decreased, Rash, Large Intestinal Haemorrhage

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Ipilimumab
    Indication: Malignant Melanoma
    Start date: 2011-08-04
    End date: 2011-09-16

Leukine
    Indication: Malignant Melanoma
    Start date: 2011-08-04
    End date: 2011-09-19



Possible Leukine side effects in

Reported by a consumer/non-health professional from Germany on 2012-02-01

Patient:

Reactions: Pruritus, Fatigue, Diarrhoea, Hyponatraemia, Endocrine Disorder, Renal Failure Acute, Hypokalaemia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Antineoplastic Agents
    Dosage: 10 mg/kg, q3w
    Indication: Malignant Melanoma
    Start date: 2011-10-20
    End date: 2012-01-04

Leukine
    Dosage: 125 mcg/m2, d1-14 q21d
    Indication: Malignant Melanoma
    Start date: 2011-10-20
    End date: 2012-01-18

Other drugs received by patient: Diphenhydramine HCL; Lisinopril; Famotidine; Metoprolol Tartrate; Valsartan



Possible Leukine side effects in 83 year old female

Reported by a consumer/non-health professional from United States on 2011-12-20

Patient: 83 year old female, weighing 46.0 kg (101.2 pounds)

Reactions: Fatigue, Diarrhoea, Dehydration

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ipilimumab
    Dosage: last dose:15jul2011 10mg/kg over 90mins
    Indication: Malignant Melanoma
    Start date: 2011-05-13
    End date: 2011-07-15

Leukine
    Dosage: last dose:28jul2011 250mcg/day on days 1-14
    Indication: Malignant Melanoma
    Start date: 2011-05-13
    End date: 2011-07-28



Possible Leukine side effects in 76 year old female

Reported by a consumer/non-health professional from United States on 2011-12-06

Patient: 76 year old female, weighing 64.0 kg (140.8 pounds)

Reactions: Large Intestine Perforation, Embolism, Diarrhoea, Platelet Count Decreased, Rash, Large Intestinal Haemorrhage

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Ipilimumab
    Indication: Malignant Melanoma
    Start date: 2011-08-04
    End date: 2011-09-16

Leukine
    Indication: Malignant Melanoma
    Start date: 2011-08-04
    End date: 2011-09-19



Possible Leukine side effects in 76 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2011-11-29

Patient: 76 year old female, weighing 64.0 kg (140.8 pounds)

Reactions: Large Intestine Perforation, Embolism, Diarrhoea, Platelet Count Decreased, Rash, Large Intestinal Haemorrhage

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ipilimumab
    Indication: Malignant Melanoma
    Start date: 2011-08-04
    End date: 2011-09-16

Leukine
    Indication: Malignant Melanoma
    Start date: 2011-08-04
    End date: 2011-09-19



Possible Leukine side effects in 76 year old female

Reported by a consumer/non-health professional from United States on 2011-11-24

Patient: 76 year old female, weighing 64.0 kg (140.8 pounds)

Reactions: Large Intestine Perforation, Embolism, Diarrhoea, Platelet Count Decreased, Rash, Large Intestinal Haemorrhage

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ipilimumab
    Indication: Malignant Melanoma
    Start date: 2011-08-04
    End date: 2011-09-16

Leukine
    Indication: Malignant Melanoma
    Start date: 2011-08-04
    End date: 2011-09-19



Possible Leukine side effects in 53 year old female

Reported by a consumer/non-health professional from United States on 2011-11-03

Patient: 53 year old female, weighing 48.0 kg (105.6 pounds)

Reactions: Weight Decreased, Hyperkalaemia, Anaemia, Pyrexia, Constipation, Hypokalaemia, Small Intestinal Obstruction, Syncope, Renal Failure, Ileus, Diarrhoea, Colitis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ipilimumab
    Dosage: last dose on 06sep2011 (600 mg)
    Indication: Malignant Melanoma
    Start date: 2011-07-25
    End date: 2011-09-06

Leukine
    Dosage: last dose on 19sep2011
    Indication: Malignant Melanoma
    Start date: 2011-07-25
    End date: 2011-09-19

Other drugs received by patient: Fosamax; Colace; Celexa; Phenergan HCL; Nexium; Zofran; Flonase; Cepastat



Possible Leukine side effects in 76 year old female

Reported by a consumer/non-health professional from United States on 2011-11-02

Patient: 76 year old female, weighing 64.0 kg (140.8 pounds)

Reactions: Gastrointestinal Haemorrhage, Diarrhoea, Rash

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ipilimumab
    Indication: Malignant Melanoma
    Start date: 2011-08-04
    End date: 2011-09-16

Leukine
    Indication: Malignant Melanoma
    Start date: 2011-08-04
    End date: 2011-09-19



Possible Leukine side effects in 76 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2011-10-28

Patient: 76 year old female, weighing 64.0 kg (140.8 pounds)

Reactions: Gastrointestinal Haemorrhage, Diarrhoea

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ipilimumab
    Indication: Malignant Melanoma
    Start date: 2011-08-04
    End date: 2011-09-16

Leukine
    Indication: Malignant Melanoma
    Start date: 2011-08-04
    End date: 2011-09-19



Possible Leukine side effects in 53 year old female

Reported by a consumer/non-health professional from United States on 2011-10-24

Patient: 53 year old female, weighing 48.0 kg (105.6 pounds)

Reactions: Weight Decreased, Renal Failure, Syncope, Diarrhoea, Hyperkalaemia, Anaemia, Colitis, Pyrexia, Hypokalaemia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ipilimumab
    Dosage: last dose on 06sep2011 (600 mg)
    Indication: Malignant Melanoma
    Start date: 2011-07-25
    End date: 2011-09-06

Leukine
    Dosage: last dose on 19sep2011
    Indication: Malignant Melanoma
    Start date: 2011-07-25
    End date: 2011-09-19

Other drugs received by patient: Zofran; Phenergan HCL; Nexium; Celexa; Flonase; Fosamax; Cepastat; Colace



Possible Leukine side effects in 53 year old female

Reported by a consumer/non-health professional from United States on 2011-10-20

Patient: 53 year old female, weighing 48.0 kg (105.6 pounds)

Reactions: Weight Decreased, Syncope, Renal Failure, Diarrhoea, Hyperkalaemia, Anaemia, Colitis, Pyrexia, Hypokalaemia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ipilimumab
    Dosage: last dose on 06sep2011 (600 mg)
    Indication: Malignant Melanoma
    Start date: 2011-07-25
    End date: 2011-09-06

Leukine
    Dosage: last dose on 19sep2011
    Indication: Malignant Melanoma
    Start date: 2011-07-25
    End date: 2011-09-19

Other drugs received by patient: Nexium; Fosamax; Phenergan HCL; Colace; Zofran; Cepastat; Celexa; Flonase



Possible Leukine side effects in 79 year old female

Reported by a consumer/non-health professional from United States on 2011-10-19

Patient: 79 year old female, weighing 55.0 kg (121.0 pounds)

Reactions: Diarrhoea, Dehydration, Abdominal Distension, Muscular Weakness, Hyponatraemia, Pyrexia, Fall, Enterocolitis Infectious

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ipilimumab
    Dosage: last dose on 01sep2011 (553 mg)
    Indication: Malignant Melanoma
    Start date: 2011-06-30

Leukine
    Dosage: last dose on 14sep2011, total dose to date= 14 mg
    Indication: Malignant Melanoma
    Start date: 2011-06-30



Possible Leukine side effects in 79 year old female

Reported by a consumer/non-health professional from United States on 2011-10-18

Patient: 79 year old female, weighing 55.0 kg (121.0 pounds)

Reactions: Diarrhoea, Dehydration, Abdominal Distension, Hyponatraemia, Pyrexia, Fall, Enterocolitis Infectious

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ipilimumab
    Dosage: last dose on 01sep2011 (553 mg)
    Indication: Malignant Melanoma
    Start date: 2011-06-30

Leukine
    Dosage: last dose on 14sep2011, total dose to date= 14 mg
    Indication: Malignant Melanoma
    Start date: 2011-06-30



Possible Leukine side effects in 79 year old female

Reported by a consumer/non-health professional from United States on 2011-10-13

Patient: 79 year old female, weighing 55.0 kg (121.0 pounds)

Reactions: Diarrhoea, Dehydration, Clostridium Difficile Colitis, Hyponatraemia, Abdominal Distension, Pyrexia, Fall

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ipilimumab
    Dosage: last dose on 01sep2011 (553 mg)
    Indication: Malignant Melanoma
    Start date: 2011-06-30

Leukine
    Dosage: last dose on 14sep2011, total dose to date= 14 mg
    Indication: Malignant Melanoma
    Start date: 2011-06-30



Possible Leukine side effects in 50 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2011-10-02

Patient: 50 year old female, weighing 64.0 kg (140.8 pounds)

Reactions: Large Intestine Perforation, Back Pain, Diarrhoea, Dehydration, Hypoalbuminaemia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ipilimumab
    Dosage: last dose:29aug2011, total dose this course 620 mg.
    Indication: Malignant Melanoma
    Start date: 2011-07-18
    End date: 2011-08-29

Leukine
    Dosage: last dose: 06sep2011; total dose this course 2250 mg, 250 mcg/day on day 1-14
    Indication: Malignant Melanoma
    Start date: 2011-07-18
    End date: 2011-09-06

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