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Leukine (Sargramostim) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Leukine (Sargramostim) and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.

Reports by Event Outcome

All Cases (140)
Death (21)

Reports by Reaction Type

Diarrhoea (24)Nausea (20)Fatigue (18)Dehydration (17)Dyspnoea (16)Abdominal Pain (15)Pyrexia (15)Adrenal Insufficiency (14)Syncope (13)Rash (12)Decreased Appetite (11)Hypotension (11)

Below are a few examples of reports where side effects / adverse reactions may be related to Leukine (Sargramostim). For a complete list or a specific selection of reports, please use the links above.

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 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

Reported by a consumer/non-health professional from United States on 2012-08-17

Patient:

Reactions: Death, Infusion Related Reaction

Adverse event resulted in: death

Drug(s) suspected as cause:
Leukine



Possible Leukine side effects in

Reported by a consumer/non-health professional from United States on 2012-08-17

Patient:

Reactions: Death, Infusion Related Reaction

Adverse event resulted in: death

Drug(s) suspected as cause:
Leukine



Possible Leukine side effects in

Reported by a consumer/non-health professional from United States on 2012-08-17

Patient:

Reactions: Death, Infusion Related Reaction

Adverse event resulted in: death

Drug(s) suspected as cause:
Leukine



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 84 year old male

Reported by a consumer/non-health professional from United States on 2012-08-10

Patient: 84 year old male, weighing 94.0 kg (206.8 pounds)

Reactions: Autoimmune Disorder, Oedema Peripheral, Arthritis

Drug(s) suspected as cause:
Ipilimumab
    Dosage: 10 mg/kg, on day 1of 21 day cycle (cycle 1-4)
    Indication: Malignant Melanoma
    Start date: 2011-04-21

Ipilimumab
    Dosage: 870 mg, once, q12 weeks
    Start date: 2012-03-07
    End date: 2012-03-07

Leukine
    Dosage: 250 mcg, 14 days
    Start date: 2012-03-07
    End date: 2012-03-20

Leukine
    Dosage: 250 mcg, qd on days 1-14 of a 21 day cycle
    Indication: Malignant Melanoma
    Start date: 2011-04-21



Possible Leukine side effects in 82 year old male

Reported by a consumer/non-health professional from United States on 2012-08-10

Patient: 82 year old male

Reactions: Haematochezia, Diarrhoea, Colitis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ipilimumab
    Dosage: 10 mg/kg, qd on day 1of a 21 day cycle
    Indication: Malignant Melanoma
    Start date: 2011-04-21
    End date: 2011-06-24

Leukine
    Dosage: 250 mcg, qd on days1-14 of a 21 day cycle
    Indication: Malignant Melanoma
    Start date: 2011-04-21
    End date: 2011-07-07

Other drugs received by patient: Sulfamethoprim



Possible Leukine side effects in 82 year old male

Reported by a consumer/non-health professional from United States on 2012-08-10

Patient: 82 year old male, weighing 77.3 kg (170.1 pounds)

Reactions: Haematochezia, Diarrhoea, Arthralgia, Presyncope, Colitis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ipilimumab
    Dosage: 10 mg/kg over 90 min on day 1
    Indication: Malignant Melanoma
    Start date: 2011-04-21
    End date: 2011-06-24

Leukine
    Dosage: 250 mcg, qd, on days 1-14
    Indication: Malignant Melanoma
    Start date: 2011-04-21
    End date: 2011-07-07

Other drugs received by patient: Aspirin; Doxazosin Mesylate; Preservision EYE Vitamin and Mineral Suppl.; Prednisone TAB; Doxazosin Mesylate; Prilosec; Magnesium



Possible Leukine side effects in 67 year old male

Reported by a health professional (non-physician/pharmacist) from Germany on 2012-08-02

Patient: 67 year old male

Reactions: Neoplasm Malignant

Adverse event resulted in: death

Drug(s) suspected as cause:
CPG 7909
    Dosage: unk(day 1 and day 15)
    Start date: 2009-07-04
    End date: 2009-07-04

CPG 7909
    Dosage: unk(day 1 and day 15)
    Indication: Malignant Melanoma
    Start date: 2009-06-11
    End date: 2009-06-11

CPG 7909
    Dosage: unk(day 1 and day 15)
    Start date: 2009-06-23
    End date: 2009-06-23

CPG 7909
    Dosage: unk(day 1 and day 15)
    Start date: 2009-07-23
    End date: 2009-07-23

Investigational Drug
    Dosage: unk(day 1 and day 15)
    Start date: 2009-06-23
    End date: 2009-06-23

Investigational Drug
    Dosage: unk(day 1 and day 15)
    Start date: 2009-07-23
    End date: 2009-07-23

Investigational Drug
    Dosage: unk(day 1 and day 15)
    Start date: 2009-07-23
    End date: 2009-07-23

Investigational Drug
    Dosage: unk (day 1 and day 15)
    Indication: Malignant Melanoma
    Start date: 2009-06-11
    End date: 2009-06-11

Investigational Drug
    Dosage: unk()day 1 and day 15
    Start date: 2009-06-23
    End date: 2009-06-23

Investigational Drug
    Dosage: unk(day 1 and day 15)
    Start date: 2009-07-04
    End date: 2009-07-04

Investigational Drug
    Dosage: unk(day 1 and day 15)
    Start date: 2009-06-11
    End date: 2009-06-11

Investigational Drug
    Dosage: unk(day 1 and day 15)
    Start date: 2009-07-04
    End date: 2009-07-04

Leukine
    Dosage: unk(day 1 and day 15)
    Start date: 2009-07-23
    End date: 2009-07-23

Leukine
    Dosage: unk(day 1 and day 15)
    Start date: 2009-06-23
    End date: 2009-06-23

Leukine
    Dosage: unk(day 1 and day 15)
    Indication: Malignant Melanoma
    Start date: 2009-06-11
    End date: 2009-06-11

Leukine
    Dosage: unk(day 1 and day 15)
    Start date: 2009-07-04
    End date: 2009-07-04

Other Cytokines and Immunomodulating Agents
    Dosage: unk(day 1 and day15)
    Start date: 2009-06-23
    End date: 2009-06-23

Other Cytokines and Immunomodulating Agents
    Dosage: unk(day 1 and day 15)
    Indication: Malignant Melanoma
    Start date: 2009-06-11
    End date: 2009-06-11

Other Cytokines and Immunomodulating Agents
    Dosage: unk(day 1 and day 15)
    Start date: 2009-07-04
    End date: 2009-07-04

Other Cytokines and Immunomodulating Agents
    Dosage: unk(day 1 and day 15)
    Start date: 2009-07-23
    End date: 2009-07-23

Vaccines
    Dosage: unk(day 1 and day 15)
    Start date: 2009-07-04
    End date: 2009-07-04

Vaccines
    Dosage: unk(day 1 and day 15)
    Start date: 2009-07-23
    End date: 2009-07-23

Vaccines
    Dosage: unk(day 1 and day 15)
    Indication: Malignant Melanoma
    Start date: 2009-06-11
    End date: 2009-06-11

Vaccines
    Dosage: unk(day 1 and day 15)
    Start date: 2009-06-23
    End date: 2009-06-23



Possible Leukine side effects in 67 year old male

Reported by a health professional (non-physician/pharmacist) from Germany on 2012-07-30

Patient: 67 year old male

Reactions: Neoplasm Malignant

Adverse event resulted in: death

Drug(s) suspected as cause:
CPG 7909
    Dosage: unk(day 1 and day 15)
    Indication: Malignant Melanoma
    Start date: 2009-06-11
    End date: 2009-06-11

CPG 7909
    Dosage: unk(day 1 and day 15)
    Start date: 2009-06-23
    End date: 2009-06-23

CPG 7909
    Dosage: unk(day 1 and day 15)
    Start date: 2009-07-04
    End date: 2009-07-04

CPG 7909
    Dosage: unk(day 1 and day 15)
    Start date: 2009-07-23
    End date: 2009-07-23

Investigational Drug
    Dosage: unk(day 1 and day 15)
    Start date: 2009-06-11
    End date: 2009-06-11

Investigational Drug
    Dosage: unk (day 1 and day 15)
    Indication: Malignant Melanoma
    Start date: 2009-06-11
    End date: 2009-06-11

Investigational Drug
    Dosage: unk(day 1 and day 15)
    Start date: 2009-07-04
    End date: 2009-07-04

Investigational Drug
    Dosage: unk(day 1 and day 15)
    Start date: 2009-07-23
    End date: 2009-07-23

Investigational Drug
    Dosage: unk(day 1 and day 15)
    Start date: 2009-07-23
    End date: 2009-07-23

Investigational Drug
    Dosage: unk(day 1 and day 15)
    Start date: 2009-06-23
    End date: 2009-06-23

Investigational Drug
    Dosage: unk(day 1 and day 15)
    Start date: 2009-07-04
    End date: 2009-07-04

Investigational Drug
    Dosage: unk()day 1 and day 15
    Start date: 2009-06-23
    End date: 2009-06-23

Leukine
    Dosage: unk(day 1 and day 15)
    Start date: 2009-07-23
    End date: 2009-07-23

Leukine
    Dosage: unk(day 1 and day 15)
    Indication: Malignant Melanoma
    Start date: 2009-06-11
    End date: 2009-06-11

Leukine
    Dosage: unk(day 1 and day 15)
    Start date: 2009-06-23
    End date: 2009-06-23

Leukine
    Dosage: unk(day 1 and day 15)
    Start date: 2009-07-04
    End date: 2009-07-04

Other Cytokines and Immunomodulating Agents
    Dosage: unk(day 1 and day 15)
    Start date: 2009-07-04
    End date: 2009-07-04

Other Cytokines and Immunomodulating Agents
    Dosage: unk(day 1 and day 15)
    Start date: 2009-07-23
    End date: 2009-07-23

Other Cytokines and Immunomodulating Agents
    Dosage: unk(day 1 and day 15)
    Indication: Malignant Melanoma
    Start date: 2009-06-11
    End date: 2009-06-11

Other Cytokines and Immunomodulating Agents
    Dosage: unk(day 1 and day15)
    Start date: 2009-06-23
    End date: 2009-06-23

Vaccines
    Dosage: unk(day 1 and day 15)
    Start date: 2009-06-23
    End date: 2009-06-23

Vaccines
    Dosage: unk(day 1 and day 15)
    Start date: 2009-07-23
    End date: 2009-07-23

Vaccines
    Dosage: unk(day 1 and day 15)
    Start date: 2009-07-04
    End date: 2009-07-04

Vaccines
    Dosage: unk(day 1 and day 15)
    Indication: Malignant Melanoma
    Start date: 2009-06-11
    End date: 2009-06-11



Possible Leukine side effects in 60 year old male

Reported by a consumer/non-health professional from Germany on 2012-07-27

Patient: 60 year old male, weighing 79.0 kg (173.8 pounds)

Reactions: Gastrointestinal Pain, Lymphadenopathy, Hyperglycaemia, Anaemia, Hypoalbuminaemia, Hepatic Lesion, Headache, Metastases To Central Nervous System

Drug(s) suspected as cause:
Ipilimumab
    Dosage: 10 mg/kg, qd over 90min day 1q12h
    Start date: 2011-08-22
    End date: 2011-08-22

Ipilimumab
    Dosage: 10 mg/kg, qd over 90min on day 1 cycle 1-4
    Indication: Malignant Melanoma
    Start date: 2011-06-20
    End date: 2011-06-20

Leukine
    Dosage: 250 mcg, qd on days 1-14
    Indication: Malignant Melanoma
    Start date: 2011-06-20

Leukine
    Dosage: 250 mcg, qd on day 1-14
    End date: 2011-10-30

Other drugs received by patient: Acetylcysteine; Metoprolol; Multivitamin and Mineral; Multi-Vitamins; Simvastatin; Coenzyme Q10; Selenium; Aspirin; Melatonin; Ibuprofen



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 female

Reported by a consumer/non-health professional from United States on 2012-07-24

Patient: female

Reactions: Endometrial Cancer

Drug(s) suspected as cause:
Leukine



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 female

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

Patient: female, weighing 57.7 kg (127.0 pounds)

Reactions: Abdominal Discomfort, Nausea, Diarrhoea, Injection Site Reaction, Urinary Tract Infection, Colitis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ipilimumab
    Dosage: unk
    Start date: 2011-08-04
    End date: 2011-08-25

Ipilimumab
    Dosage: 10 mg/kg, (day 1, q12 wks)
    Indication: Malignant Melanoma
    Start date: 2011-08-04
    End date: 2011-08-04

Ipilimumab
    Dosage: 10 mg/kg, day 1, q12wks
    Start date: 2011-12-29
    End date: 2011-12-29

Ipilimumab
    Dosage: 10 mg/kg, (days 1, q12 wks)
    Start date: 2011-08-25
    End date: 2011-08-25

Leukine
    Dosage: 250 mcg, qd (days 1-14)
    Start date: 2012-01-19
    End date: 2012-02-01

Leukine
    Dosage: 250 mcg, qd(days 1-14)
    Indication: Malignant Melanoma
    Start date: 2011-08-04
    End date: 2011-08-17

Other drugs received by patient: Klonopin; Ascorbic Acid; Wellbutrin; Extra Strength Tylenol; Clonazepam; Effexor; Multi-Vitamins; Lasix; Selenium; Difenhydramin; Aspirin; Vitamin D; Prilosec



Possible Leukine side effects in

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

Patient:

Reactions: Sick Sinus Syndrome, Hypothyroidism, Conduction Disorder

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Antineoplastic Agents
    Dosage: 10 mg/kg, on day 1
    Indication: Malignant Melanoma
    Start date: 2011-04-25
    End date: 2011-06-27

Antineoplastic Agents
    Dosage: 10 mg/kg
    End date: 2011-07-27

Leukine
    Dosage: 250 mcg, qd,
    End date: 2011-08-22

Leukine
    Dosage: 250 mcg, qd
    Indication: Malignant Melanoma
    Start date: 2011-04-25
    End date: 2011-07-31



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

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 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 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 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 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 53 year old male

Reported by a physician from United States on 2012-06-29

Patient: 53 year old male

Reactions: Wound Dehiscence, Gastrointestinal Stoma Complication, Wound Infection

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Dexamethasone

Ipilimumab
    Indication: Malignant Melanoma
    Start date: 2011-05-26
    End date: 2012-01-12

Leukine
    Indication: Malignant Melanoma
    Start date: 2011-05-26
    End date: 2012-01-26



Possible Leukine side effects in 60 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-29

Patient: 60 year old female

Reactions: Back Pain, Chest Discomfort, Chest Pain, Musculoskeletal Discomfort

Drug(s) suspected as cause:
Leukine

Other drugs received by patient: Antineoplastic Agents; Antineoplastic Agents



Possible Leukine side effects in

Reported by a physician from United States on 2012-06-27

Patient:

Reactions: Vomiting, Chills

Drug(s) suspected as cause:
Leukine

Other drugs received by patient: Acetaminophen; Benadryl

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