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Index of reports
> Cases with Dehydration (17)
Below is the selection of side effect reports (a.k.a. adverse event reports) related to Leukine (Sargramostim) where reactions include dehydration. 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 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
Reported by a physician from Germany on 2012-07-16
Patient:
Reactions: Dehydration, Hypotension, Dizziness, Hypophysitis, Hypothyroidism, Headache, Blood Prolactin Abnormal
Drug(s) suspected as cause:
Leukine
Dosage: 250 mg, qd days 1-14 of 21 day cycle
Indication: Malignant Melanoma
Start date: 2011-06-28
Leukine
Dosage: 250 mg, qd days 1-14 of 21 day cycle
Start date: 2012-02-14
Leukine
Dosage: 250 mg, qd days 1-14 of 21 day cycle
Start date: 2011-08-30
End date: 2011-09-12
Other drugs received by patient: Citalopram Hydrobromide; Ketoconazole; Januvia; Docusate Sodium; Benadryl; Glyburide; Benadryl Itch; Gold Bond; Antineoplastic Agents; Metoprolol Tartrate; Digoxin; Ranitidine; Warfarin Sodium; Sarna; Atarax; Lantus; Humulin N; Lisinopril; Crestor; Ibuprofen; Finasteride; Gabapentin; Imodium Multi-Symptom Relief; Elavil; Prochlorperazine Maleate; Polyethylene Glycol
Possible Leukine side effects in 80 year old male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-06
Patient: 80 year old male, weighing 89.0 kg (195.8 pounds)
Reactions: Pneumonia, Dehydration, Muscular Weakness, Decreased Appetite
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Ipilimumab
Dosage: 10mg/kg iv over 90 min on day1.cycle 4 day 1.delayed for 14days.last dose on 08aug11.
Indication: Malignant Melanoma
Start date: 2011-06-27
Leukine
Dosage: last dose:21aug2011
Indication: Malignant Melanoma
Start date: 2011-06-27
Possible Leukine side effects in 75 year old male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-04-16
Patient: 75 year old male, weighing 82.0 kg (180.4 pounds)
Reactions: Hypotension, Dehydration, Hyponatraemia, Atrial Fibrillation
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Ipilimumab
Dosage: 10mg/kg iv over 90 mins on d1 q12 wk,no of course-2,last dose on 05jul2011.interrupt on 18jul2011
Indication: Malignant Melanoma
Start date: 2011-06-13
Leukine
Dosage: last admin. 18-jul-2011
Indication: Malignant Melanoma
Start date: 2011-06-13
Metoprolol Tartrate
Possible Leukine side effects in 80 year old male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-03-12
Patient: 80 year old male, weighing 89.0 kg (195.8 pounds)
Reactions: Pneumonia, Dehydration, Decreased Appetite
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Ipilimumab
Dosage: 10mg/kg iv over 90 min on day1.cycle 4 day 1.delayed for 14days.last dose on 08aug11.
Indication: Malignant Melanoma
Start date: 2011-06-27
Leukine
Dosage: last dose:21aug2011
Indication: Malignant Melanoma
Start date: 2011-06-27
Possible Leukine side effects in 75 year old male
Reported by a consumer/non-health professional from United States on 2012-02-19
Patient: 75 year old male, weighing 82.0 kg (180.4 pounds)
Reactions: Hypotension, Dehydration, Atrial Fibrillation, Hyponatraemia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Ipilimumab
Dosage: 10mg/kg iv over 90 mins on d1 q12 wk,no of course-2,last dose on 05jul2011.interrupt on 18jul2011
Indication: Malignant Melanoma
Start date: 2011-06-13
Leukine
Dosage: last admin. 18-jul-2011
Indication: Malignant Melanoma
Start date: 2011-06-13
Metoprolol Tartrate
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 77 year old male
Reported by a consumer/non-health professional from United States on 2011-10-28
Patient: 77 year old male, weighing 106.0 kg (233.2 pounds)
Reactions: Vomiting, Nausea, Dehydration, Adrenal Insufficiency, Fall, Decreased Appetite, Renal Failure Acute
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Ipilimumab
Dosage: last dose on 12aug11
Indication: Malignant Melanoma
Start date: 2011-03-18
End date: 2011-08-12
Leukine
Dosage: cont and last dose on 06oct11
Indication: Malignant Melanoma
Start date: 2011-03-18
End date: 2011-09-01
Possible Leukine side effects in 77 year old male
Reported by a consumer/non-health professional from United States on 2011-10-25
Patient: 77 year old male, weighing 106.0 kg (233.2 pounds)
Reactions: Vomiting, Nausea, Dehydration, Adrenal Insufficiency, Fall, Renal Failure Acute, Decreased Appetite
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Ipilimumab
Dosage: last dose on 12aug11
Indication: Malignant Melanoma
Start date: 2011-03-18
End date: 2011-08-12
Leukine
Dosage: cont and last dose on 06oct11
Indication: Malignant Melanoma
Start date: 2011-03-18
End date: 2011-09-01
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 77 year old male
Reported by a consumer/non-health professional from United States on 2011-10-13
Patient: 77 year old male, weighing 106.0 kg (233.2 pounds)
Reactions: Dehydration, Fall, Decreased Appetite
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Ipilimumab
Dosage: last dose on 12aug11
Indication: Malignant Melanoma
Start date: 2011-03-18
End date: 2011-08-12
Leukine
Dosage: cont and last dose on 06oct11
Indication: Malignant Melanoma
Start date: 2011-03-18
End date: 2011-09-01
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
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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