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

 
 



Index of reports > Cases with Dyspnoea (16)

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

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:
Leukine
    Dosage: last dose on 07nov2011,courses:16
    Indication: Malignant Melanoma
    Start date: 2011-08-02

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

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:
Leukine
    Dosage: last dose on 07nov2011,courses:16
    Indication: Malignant Melanoma
    Start date: 2011-08-02

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

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:
Leukine
    Dosage: 250 mcg, qd (on days 1-14) maintenance therapy

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) 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 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

Leukine
    Dosage: 250 mcg/day, on day 1-14

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

Leukine
    Dosage: 250 mcg, qd
    Indication: Malignant Melanoma
    Start date: 2011-10-04
    End date: 2011-10-18

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, 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

Antineoplastic Agents
    Dosage: 10 mg/kg, once
    Start date: 2011-08-23
    End date: 2011-08-23

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:
Leukine
    Dosage: last dose on 07nov2011,courses:16
    Indication: Malignant Melanoma
    Start date: 2011-08-02

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

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:
Leukine
    Dosage: 250 mcg, qd
    Start date: 2011-09-13
    End date: 2011-09-26

Leukine
    Dosage: 250 mcg/day, on day 1-14

Antineoplastic Agents
    Dosage: 10 mg/kg, once
    Start date: 2011-09-13
    End date: 2011-09-13

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

Antineoplastic Agents
    Dosage: 10 mg/kg, once
    Start date: 2011-08-23
    End date: 2011-08-23

Leukine
    Dosage: 250 mcg, qd
    Start date: 2011-08-23
    End date: 2011-09-05

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

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 35 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-01-27

Patient: 35 year old female, weighing 87.0 kg (191.4 pounds)

Reactions: Dyspnoea

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Leukine
    Dosage: last administered dt:02jan2012,no of courses:12
    Indication: Malignant Melanoma
    Start date: 2011-05-04

Proleukin

Ipilimumab
    Dosage: last administered dt:19dec2011,no of courses:12
    Indication: Malignant Melanoma
    Start date: 2011-05-04



Possible Leukine side effects in 35 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-01-27

Patient: 35 year old female, weighing 87.0 kg (191.4 pounds)

Reactions: Dyspnoea

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Leukine
    Dosage: last administered dt:02jan2012,no of courses:12
    Indication: Malignant Melanoma
    Start date: 2011-05-04

Ipilimumab
    Dosage: last administered dt:19dec2011,no of courses:12
    Indication: Malignant Melanoma
    Start date: 2011-05-04

Proleukin



Possible Leukine side effects in 63 year old male

Reported by a consumer/non-health professional from United States on 2011-12-15

Patient: 63 year old male, weighing 94.0 kg (206.8 pounds)

Reactions: Multi-Organ Failure, Dyspnoea, Hyperkalaemia, Neoplasm Malignant, Hyponatraemia, Neutrophil Count Decreased, Renal Failure Acute

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Leukine
    Dosage: last dose on 26aug11
    Indication: Malignant Melanoma
    Start date: 2011-07-21

Ipilimumab
    Dosage: last dose on 12aug11 12aug11 cycle 2
    Indication: Malignant Melanoma
    Start date: 2011-07-21

Vancomycin
    Indication: Dermatitis
    Start date: 2011-08-22
    End date: 2011-08-24

Other drugs received by patient: Mirtazapine; Milk OF Magnesia TAB; Pepcid; Prinzide; Dilaudid; Temazepam



Possible Leukine side effects in

Reported by a physician from Germany on 2011-12-06

Patient:

Reactions: Back Pain, Flushing, Dyspnoea, Chest Discomfort, Hyperhidrosis, Muscle Spasms

Drug(s) suspected as cause:
Leukine
    Dosage: unk
    Indication: Metastatic Malignant Melanoma
    Start date: 2011-06-30

Antineoplastic Agents
    Dosage: unk
    Indication: Product Used FOR Unknown Indication



Possible Leukine side effects in

Reported by a physician from United States on 2011-12-02

Patient:

Reactions: Dyspnoea

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Investigational Drug
    Dosage: 10 mg/kg, unk
    Indication: Malignant Melanoma
    Start date: 2011-04-06

Leukine
    Dosage: unk
    Indication: Malignant Melanoma

Other drugs received by patient: Duragesic-100; Pacerone; Dilaudid; Feosol; Atenolol; Zyloprim; Oxycodone HCL; Coumadin; Terazosin HCL



Possible Leukine side effects in

Reported by a consumer/non-health professional from United States on 2011-11-18

Patient:

Reactions: Flushing, Dyspnoea, Nausea, Rash

Drug(s) suspected as cause:
Leukine



Possible Leukine side effects in

Reported by a consumer/non-health professional from United States on 2011-10-26

Patient:

Reactions: Flushing, Dyspnoea, Nausea, Rash

Drug(s) suspected as cause:
Leukine



Possible Leukine side effects in

Reported by a consumer/non-health professional from United States on 2011-10-26

Patient:

Reactions: Flushing, Dyspnoea, Nausea, Rash

Drug(s) suspected as cause:
Leukine



Possible Leukine side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2011-10-25

Patient:

Reactions: Flushing, Dyspnoea, Nausea, Rash

Drug(s) suspected as cause:
Leukine



Possible Leukine side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2011-10-25

Patient:

Reactions: Flushing, Dyspnoea, Nausea, Rash

Drug(s) suspected as cause:
Leukine

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