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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 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 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 2012-07-23
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 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 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 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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