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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 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 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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