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Leukine (Sargramostim) - Abdominal Pain - Suspected Cause - Side Effect Reports

 
 



Index of reports > Cases with Abdominal Pain (15)

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

Possible Leukine side effects in 61 year old male

Reported by a physician from United States on 2012-08-22

Patient: 61 year old male, weighing 82.6 kg (181.7 pounds)

Reactions: Myalgia, Abdominal Pain, Fatigue, Stomatitis, Amylase Increased, Arthralgia, Pancreatitis, Lipase Increased, Decreased Appetite

Drug(s) suspected as cause:
Ipilimumab
    Dosage: 10 mg/kg on day 1 q12 weeks (maintenance therapy)
    End date: 2011-06-12

Ipilimumab
    Dosage: 10 mg/kg over 90 min on day 1 (induction therapy)
    Indication: Malignant Melanoma
    Start date: 2011-07-12

Leukine
    Dosage: 250 mcg (maintenance therapy) cycle 5+, total:19 cycles till date

Leukine
    Dosage: 250 mcg (induction therapy), cycle 1-4
    Indication: Malignant Melanoma
    Start date: 2011-07-12



Possible Leukine side effects in 71 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-27

Patient: 71 year old male, weighing 94.0 kg (206.8 pounds)

Reactions: Abdominal Pain, Syncope, Fatigue, Dyspnoea, Pruritus, Nausea, Adrenal Insufficiency, Cholecystitis, Decreased Appetite

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ipilimumab
    Dosage: last dose:20mar12,12jun12.cou:16,10mg/kg over 90 min on day1 ,1q12 weeks(maintenance),917mg
    Indication: Malignant Melanoma
    Start date: 2011-08-02

Leukine
    Dosage: last dose on 07nov2011,courses:16
    Indication: Malignant Melanoma
    Start date: 2011-08-02

Other drugs received by patient: Gentamicin Sulfate; Polymycin B Sulfate; Sodium Chloride; Omeprazole; Zolpidem Tartrate; Diphenhydramine HCL; Famotidine; Lorazepam; Naphazoline HCL; Pheniramine Maleate; Oxycodone HCL; Colace Caps 100 MG; Ondansetron Hydrochloride; Enoxaparin Sodium; Prednisone; Aspirin; Cosyntropin



Possible Leukine side effects in 71 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-26

Patient: 71 year old male, weighing 94.0 kg (206.8 pounds)

Reactions: Abdominal Pain, Fatigue, Syncope, Dyspnoea, Pruritus, Nausea, Adrenal Insufficiency, Cholecystitis, Decreased Appetite

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ipilimumab
    Dosage: last dose:20mar12,12jun12.cou:16,10mg/kg over 90 min on day1 ,1q12 weeks(maintenance),917mg
    Indication: Malignant Melanoma
    Start date: 2011-08-02

Leukine
    Dosage: last dose on 07nov2011,courses:16
    Indication: Malignant Melanoma
    Start date: 2011-08-02

Other drugs received by patient: Cosyntropin; Prednisone; Sodium Chloride; Zolpidem Tartrate; Omeprazole; Lorazepam; Naphazoline HCL; Colace Caps 100 MG; Diphenhydramine HCL; Gentamicin Sulfate; Ondansetron Hydrochloride; Oxycodone HCL; Polymycin B Sulfate; Enoxaparin Sodium; Famotidine; Pheniramine Maleate; Aspirin



Possible Leukine side effects in 71 year old male

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

Patient: 71 year old male, weighing 91.0 kg (200.2 pounds)

Reactions: Abdominal Pain, Angina Unstable, Headache, Transaminases Increased, Fatigue, Malaise, Dizziness, Pulmonary Oedema, Adrenal Insufficiency, Cholecystitis, Enterocolitis, Myocardial Infarction, Sinus Congestion, Cough, Metastatic Malignant Melanoma, Pneumonia, Dyspnoea, Vomiting, Nausea, Alanine Aminotransferase Increased, Hypotension, Rhinorrhoea, Hepatic Steatosis, Anxiety, Lung Disorder, Syncope, Aspartate Aminotransferase Increased, Sinus Tachycardia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Antineoplastic Agents
    Dosage: 10 mg/kg, 90 minutes on day 1, q12 weeks

Antineoplastic Agents
    Dosage: 10 mg/kg, once
    Start date: 2011-09-13
    End date: 2011-09-13

Antineoplastic Agents
    Dosage: 10 mg/kg, once
    Start date: 2011-08-02
    End date: 2011-08-02

Antineoplastic Agents
    Dosage: 10 mg/kg, once
    Indication: Malignant Melanoma
    Start date: 2011-10-04
    End date: 2011-10-04

Antineoplastic Agents
    Dosage: 10 mg/kg, once
    Start date: 2011-08-23
    End date: 2011-08-23

Leukine
    Dosage: 250 mcg/day, on day 1-14

Leukine
    Dosage: 250 mcg, qd
    Indication: Malignant Melanoma
    Start date: 2011-10-04
    End date: 2011-10-18

Leukine
    Dosage: 250 mcg, qd
    Start date: 2011-09-13
    End date: 2011-09-26

Leukine
    Dosage: 250 mcg, qd
    Start date: 2011-08-02
    End date: 2011-08-15

Leukine
    Dosage: 250 mcg, qd
    Start date: 2011-08-23
    End date: 2011-09-05

Other drugs received by patient: Hydromorphone HCL; Prednisone; Sodium Chloride; Sodium Chloride; Omeprazole; Diphenhydramine HCL; Pepcid; Enoxaparin Sodium; Oxycodone Hydrochloride; Zolpidem Tartrate; Pepcid; Clobetasol Propionate; Oxycodone Hydrochloride; Lorazepam; Famotidine; Polymyxin / Trimethoprim Sulphate; Prednisone; Cosyntropin; Omeprazole; Naphazoline Hydrochloride / Pheniramine Maleate; Ondansetron Hydrochloride; Pepcid; Docusate Sodium; Gentamicin Sulfate; Sodium Chloride



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 71 year old male

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

Patient: 71 year old male, weighing 91.0 kg (200.2 pounds)

Reactions: Abdominal Pain, Dyspnoea, Nausea, Alanine Aminotransferase Increased, Hypotension, Transaminases Increased, Hepatic Steatosis, Fatigue, Syncope, Aspartate Aminotransferase Increased, Adrenal Insufficiency, Cholecystitis, Enterocolitis, Sinus Tachycardia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Antineoplastic Agents
    Dosage: 10 mg/kg, once
    Start date: 2011-09-13
    End date: 2011-09-13

Antineoplastic Agents
    Dosage: 10 mg/kg, once
    Start date: 2011-08-23
    End date: 2011-08-23

Antineoplastic Agents
    Dosage: 10 mg/kg, 90 minutes on day 1, q12 weeks

Antineoplastic Agents
    Dosage: 10 mg/kg, once
    Start date: 2011-08-02
    End date: 2011-08-02

Antineoplastic Agents
    Dosage: 10 mg/kg, once
    Indication: Malignant Melanoma
    Start date: 2011-10-04
    End date: 2011-10-04

Leukine
    Dosage: 250 mcg, qd
    Start date: 2011-09-13
    End date: 2011-09-26

Leukine
    Dosage: 250 mcg/day, on day 1-14

Leukine
    Dosage: 250 mcg, qd
    Indication: Malignant Melanoma
    Start date: 2011-10-04
    End date: 2011-10-18

Leukine
    Dosage: 250 mcg, qd
    Start date: 2011-08-02
    End date: 2011-08-15

Leukine
    Dosage: 250 mcg, qd
    Start date: 2011-08-23
    End date: 2011-09-05

Other drugs received by patient: Naphazoline Hydrochloride / Pheniramine Maleate; Sodium Chloride; Omeprazole; Diphenhydramine HCL; Docusate Sodium; Polymyxin / Trimethoprim Sulphate; Prednisone; Zolpidem Tartrate; Hydromorphone HCL; Enoxaparin Sodium; Famotidine; Ondansetron Hydrochloride; Cosyntropin; Prednisone; Lorazepam; Clobetasol Propionate; Gentamicin Sulfate; Oxycodone Hydrochloride



Possible Leukine side effects in 71 year old male

Reported by a consumer/non-health professional from United States on 2012-07-10

Patient: 71 year old male, weighing 94.0 kg (206.8 pounds)

Reactions: Abdominal Pain, Dyspnoea, Syncope, Fatigue, Adrenal Insufficiency, Cholecystitis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ipilimumab
    Dosage: last dose:20mar12,12jun12.cou:16,10mg/kg over 90 min on day1 ,1q12 weeks(maintenance),917mg
    Indication: Malignant Melanoma
    Start date: 2011-08-02

Leukine
    Dosage: last dose on 07nov2011,courses:16
    Indication: Malignant Melanoma
    Start date: 2011-08-02

Other drugs received by patient: Cosyntropin; Naphazoline HCL; Prednisone TAB; Polymycin B Sulfate; Sodium Chloride; Diphenhydramine HCL; Docusate Sodium; Gentamicin Sulfate; Lorazepam; Ondansetron HCL; Famotidine; Zolpidem Tartrate; Enoxaparin Sodium; Pheniramine Maleate; Omeprazole; Oxycodone HCL



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 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 71 year old male

Reported by a consumer/non-health professional from United States on 2012-02-07

Patient: 71 year old male, weighing 92.0 kg (202.4 pounds)

Reactions: Abdominal Pain, Aspartate Aminotransferase Increased, Alanine Aminotransferase Increased, Transaminases Increased, Enterocolitis, Sinus Tachycardia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ipilimumab
    Dosage: last date:04oct11
    Indication: Malignant Melanoma
    Start date: 2011-08-02
    End date: 2011-10-04

Leukine
    Dosage: 250 mcg/day days 1-14 total dosing c4: 3500 mg 18oct11
    Indication: Malignant Melanoma
    Start date: 2011-08-02
    End date: 2011-11-07

Other drugs received by patient: Lorazepam; Lorazepam; Omeprazole; Clobetasol Propionate; Hydromorphone HCL



Possible Leukine side effects in 71 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2011-12-12

Patient: 71 year old male, weighing 92.0 kg (202.4 pounds)

Reactions: Abdominal Pain, Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Enterocolitis, Transaminases Increased, Sinus Tachycardia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ipilimumab
    Dosage: last date:04oct11
    Indication: Malignant Melanoma
    Start date: 2011-08-02
    End date: 2011-10-04

Leukine
    Dosage: 250 mcg/day days 1-14 total dosing c4: 3500 mg 18oct11
    Indication: Malignant Melanoma
    Start date: 2011-08-02
    End date: 2011-11-07

Other drugs received by patient: Omeprazole; Lorazepam; Lorazepam; Clobetasol Propionate; Hydromorphone HCL



Possible Leukine side effects in 71 year old male

Reported by a consumer/non-health professional from United States on 2011-11-29

Patient: 71 year old male, weighing 92.0 kg (202.4 pounds)

Reactions: Abdominal Pain, Aspartate Aminotransferase Increased, Alanine Aminotransferase Increased, Enterocolitis, Sinus Tachycardia, Transaminases Increased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ipilimumab
    Dosage: last date:04oct11
    Indication: Malignant Melanoma
    Start date: 2011-08-02
    End date: 2011-10-04

Leukine
    Dosage: 250 mcg/day days 1-14 total dosing c4: 3500 mg 18oct11
    Indication: Malignant Melanoma
    Start date: 2011-08-02
    End date: 2011-11-07

Other drugs received by patient: Clobetasol Propionate; Lorazepam; Lorazepam; Hydromorphone HCL; Omeprazole



Possible Leukine side effects in 71 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2011-11-18

Patient: 71 year old male, weighing 92.0 kg (202.4 pounds)

Reactions: Abdominal Pain, Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Transaminases Increased, Sinus Tachycardia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ipilimumab
    Dosage: last date:04oct11
    Indication: Malignant Melanoma
    Start date: 2011-08-02
    End date: 2011-10-04

Leukine
    Dosage: 250 mcg/day days 1-14 total dosing c4: 3500 mg 18oct11
    Indication: Malignant Melanoma
    Start date: 2011-08-02
    End date: 2011-11-07

Other drugs received by patient: Lorazepam; Lorazepam; Clobetasol Propionate; Omeprazole



Possible Leukine side effects in 71 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2011-11-03

Patient: 71 year old male, weighing 92.0 kg (202.4 pounds)

Reactions: Abdominal Pain, Transaminases Increased, Sinus Tachycardia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ipilimumab
    Dosage: last date:04oct11
    Indication: Malignant Melanoma
    Start date: 2011-08-02
    End date: 2011-10-04

Leukine
    Dosage: 250 mcg/day days 1-14 total dosing c4: 3500 mg
    Indication: Malignant Melanoma
    Start date: 2011-08-02
    End date: 2011-10-18

Other drugs received by patient: Lorazepam; Omeprazole; Clobetasol Propionate; Lorazepam



Possible Leukine side effects in 71 year old male

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

Patient: 71 year old male, weighing 92.0 kg (202.4 pounds)

Reactions: Abdominal Pain, Transaminases Increased, Sinus Tachycardia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ipilimumab
    Indication: Malignant Melanoma
    Start date: 2011-08-02
    End date: 2011-10-04

Leukine
    Indication: Malignant Melanoma
    Start date: 2011-08-02
    End date: 2011-10-18

Other drugs received by patient: Ativan; Ativan; Clobetasol Propionate; Omeprazole

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