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

 
 



Index of reports > Cases with Fatigue (18)

Below is the selection of side effect reports (a.k.a. adverse event reports) related to Leukine (Sargramostim) where reactions include fatigue. 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 61 year old male

Reported by a physician from United States on 2012-08-16

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

Reactions: Myalgia, Amylase Increased, Fatigue, 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 on day 1 (induction therapy)
    Indication: Malignant Melanoma
    Start date: 2011-07-12

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

Leukine
    Dosage: 250 mcg (maintenance therapy)



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 2012-07-26

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

Reactions: Blood Pressure Increased, Pruritus, Dyspnoea, Fatigue, Nausea, Rash Maculo-Papular, Decreased Appetite

Adverse event resulted in: hospitalization

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

Ipilimumab
    Dosage: 10 mg/kg, once
    Indication: Malignant Melanoma
    Start date: 2011-08-02

Leukine
    Dosage: 250 mcg, qd (on days 1-14) maintenance therapy

Leukine
    Dosage: 250 mcg, qd (on days 1-14) induction therapy
    Indication: Malignant Melanoma
    Start date: 2011-08-02

Other drugs received by patient: Zolpidem Tartrate; Prednisone; Acetylsalicylic Acid SRT; Lorazepam; Omeprazole; Colace; Lorazepam; Oxycodone HCL



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 male

Reported by a physician from Germany on 2012-07-13

Patient: male, weighing 94.8 kg (208.5 pounds)

Reactions: Metastatic Malignant Melanoma, Fatigue, Nausea, Anaemia

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Ipilimumab
    Dosage: 10 mg/kg, q21d
    Indication: Metastatic Malignant Melanoma
    Start date: 2012-05-16
    End date: 2012-06-06

Leukine
    Dosage: 125 mcg/m2, day 1-14,q21 d
    Indication: Metastatic Malignant Melanoma
    Start date: 2012-05-16
    End date: 2012-06-19

Other drugs received by patient: Zofran; Senna-Mint WAF; Colace; Omeprazole; MS Contin; Lipitor; Aspirin; Gabapentin; Miralax; Prozac; Ativan



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 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 male

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

Patient: male, weighing 94.8 kg (208.5 pounds)

Reactions: Metastatic Malignant Melanoma, Fatigue, Nausea, Anaemia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Leukine
    Dosage: 125 mcg/m2, day 1-14,q21 d
    Indication: Metastatic Malignant Melanoma
    Start date: 2012-05-16
    End date: 2012-06-19

Yervoy
    Dosage: 10 mg/kg, q21d
    Indication: Metastatic Malignant Melanoma
    Start date: 2012-05-16
    End date: 2012-06-06

Other drugs received by patient: Senna-Mint WAF; Colace; Lipitor; Miralax; Zofran; Gabapentin; Omeprazole; Prozac; Ativan; Aspirin; MS Contin



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 consumer/non-health professional from United States on 2012-06-15

Patient: 61 year old male, weighing 72.0 kg (158.4 pounds)

Reactions: Fatigue, Embolism, Neoplasm Malignant, Hypotension

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Ipilimumab
    Dosage: day 1 c3 delayed until 01sep11 start dt:1sep11 last dose:1sep11,4aug11,758mg resumed on 22sep11
    Indication: Malignant Melanoma
    Start date: 2011-07-15
    End date: 2011-10-06

Leukine
    Dosage: c3 delayed until 01sep11 start dt:1sep11 last dose:14sep11(3500mg,17aug11 resumed on 22sep11
    Indication: Malignant Melanoma
    Start date: 2011-07-15
    End date: 2011-10-06



Possible Leukine side effects in 61 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-05-28

Patient: 61 year old male, weighing 72.0 kg (158.4 pounds)

Reactions: Fatigue, Neoplasm Malignant, Embolism, Hypotension

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Ipilimumab
    Dosage: day 1 c3 delayed until 01sep11 start dt:1sep11 last dose:1sep11 resumed on 22sep11
    Indication: Malignant Melanoma
    Start date: 2011-07-15

Leukine
    Dosage: c3 delayed until 01sep11 start dt:1sep11 last dose:14sep11(3500mcg) resumed on 22sep11
    Indication: Malignant Melanoma
    Start date: 2011-07-15



Possible Leukine side effects in 61 year old male

Reported by a consumer/non-health professional from United States on 2012-05-16

Patient: 61 year old male, weighing 72.0 kg (158.4 pounds)

Reactions: Fatigue, Embolism, Neoplasm Malignant, Hypotension

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Ipilimumab
    Dosage: day 1 c3 delayed until 01sep11 start dt:1sep11 last dose:1sep11 resumed on 22sep11
    Indication: Malignant Melanoma
    Start date: 2011-07-15

Leukine
    Dosage: c3 delayed until 01sep11 start dt:1sep11 last dose:14sep11(3500mcg) resumed on 22sep11
    Indication: Malignant Melanoma
    Start date: 2011-07-15



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

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 53 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2011-11-28

Patient: 53 year old male, weighing 121.0 kg (266.2 pounds)

Reactions: Dermatitis Acneiform, Vomiting, Nausea, Mental Status Changes, Hyponatraemia, Hypokalaemia, Fatigue, Hypopituitarism, Adrenal Insufficiency, Hypocalcaemia, Hyperthyroidism, Septic Shock, Decreased Appetite, Lethargy, Blood Pressure Diastolic Decreased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ipilimumab
    Dosage: last dose:28jul2011 dosage:total dose last course: 1246 mg
    Indication: Malignant Melanoma
    Start date: 2011-05-26

Leukine
    Dosage: last dose:03aug2011 dosage:250mcg/day iv over 90min on day 1-14
    Indication: Malignant Melanoma
    Start date: 2011-05-26

Other drugs received by patient: Synthroid

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