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 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 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 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 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 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 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 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 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 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 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
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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