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

 
 



Index of reports > Cases with Syncope (13)

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

Possible Leukine side effects in male

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

Patient: male

Reactions: Rectal Haemorrhage, Constipation, Cardiac Disorder, Hospitalisation, Granulocytopenia, Inappropriate Antidiuretic Hormone Secretion, Thrombocytopenia, Cardiac Failure Congestive, Pneumonia, Anaemia, Pancytopenia, Atrial Fibrillation, Febrile Neutropenia, Syncope, Embolism, Sepsis, Dehydration, Asthenia, Mantle Cell Lymphoma Recurrent, Leukopenia, Deep Vein Thrombosis, Infection

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Cyclophosphamide
    Dosage: on day 1
    Indication: Mantle Cell Lymphoma

Cyclophosphamide
    Dosage: on day 1
    Indication: Diffuse Large B-Cell Lymphoma

Doxorubicin HCL
    Dosage: on day 1
    Indication: Diffuse Large B-Cell Lymphoma

Doxorubicin HCL
    Dosage: on day 1
    Indication: Mantle Cell Lymphoma

Leukine
    Dosage: on day 9-15; 250 mcg/m2/day
    Indication: Mantle Cell Lymphoma

Leukine
    Dosage: on day 9-15; 250 mcg/m2/day
    Indication: Diffuse Large B-Cell Lymphoma

Prednisone TAB
    Dosage: on days 1-5
    Indication: Mantle Cell Lymphoma

Prednisone TAB
    Dosage: on days 1-5
    Indication: Diffuse Large B-Cell Lymphoma

Rituximab
    Dosage: on day 15; as infusion
    Indication: Diffuse Large B-Cell Lymphoma

Rituximab
    Dosage: on day 15; as infusion
    Indication: Mantle Cell Lymphoma

Vincristine
    Dosage: on day 1 (maximum dose: 2mg)
    Indication: Diffuse Large B-Cell Lymphoma

Vincristine
    Dosage: on day 1 (maximum dose: 2mg)
    Indication: Mantle Cell Lymphoma



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 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 71 year old male

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

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

Reactions: Syncope, Adrenal Insufficiency, Cholecystitis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ipilimumab
    Dosage: last dose: 20mar2012. courses:14. 10mg/kg over 90 min on day1 ,1q12 weeks(maintenance)
    Indication: Malignant Melanoma
    Start date: 2011-08-02

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



Possible Leukine side effects in 71 year old male

Reported by a consumer/non-health professional from United States on 2012-05-11

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

Reactions: Syncope, Adrenal Insufficiency, Cholecystitis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ipilimumab
    Dosage: last dose on 20mar2012
    Indication: Malignant Melanoma
    Start date: 2011-08-02

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



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 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 62 year old male

Reported by a consumer/non-health professional from United States on 2011-10-07

Patient: 62 year old male, weighing 112.0 kg (246.4 pounds)

Reactions: Syncope, Dehydration, Hypotension

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ipilimumab
    Indication: Malignant Melanoma
    Start date: 2011-06-29
    End date: 2011-07-20

Leukine
    Indication: Malignant Melanoma
    Start date: 2011-06-29
    End date: 2011-08-02



Possible Leukine side effects in 62 year old male

Reported by a consumer/non-health professional from United States on 2011-10-03

Patient: 62 year old male, weighing 112.0 kg (246.4 pounds)

Reactions: Syncope, Dehydration, Hypotension

Drug(s) suspected as cause:
Ipilimumab
    Indication: Malignant Melanoma
    Start date: 2011-06-29
    End date: 2011-07-20

Leukine
    Indication: Malignant Melanoma
    Start date: 2011-06-29
    End date: 2011-08-02

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