This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Proleukin (Aldesleukin) 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 (36)
Death (10)
Life Threatening Events (3)
Disability (1)
Reports by Reaction Type
Neoplasm Progression (7),
Hypotension (6),
Unresponsive To Stimuli (5),
Dyspnoea (5),
Infection (4),
Mental Status Changes (4),
Tachycardia (3),
Oedema Peripheral (3),
Oedema (3),
Pleural Effusion (3),
Intestinal Ischaemia (3),
Hyponatraemia (3)
Below are a few examples of reports where side effects / adverse reactions may be related to Proleukin (Aldesleukin). For a complete list or a specific selection of reports, please use the links above.
Possible Proleukin side effects in male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-20
Patient: male, weighing 41.7 kg (91.7 pounds)
Reactions: Pancreatitis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Proleukin
Dosage: 4.5 miu on days 0-4
Indication: Neuroblastoma
Start date: 2012-07-23
End date: 2012-07-27
Irinotecan Hydrochloride
Dosage: 250 mg
Indication: Neuroblastoma
Start date: 2012-08-06
Oxaliplatin
Dosage: 120 mg iv
Indication: Neuroblastoma
Start date: 2012-08-06
Zoledronic
Dosage: 4 mg iv on day 0
Indication: Neuroblastoma
Start date: 2012-07-23
Gemcitabine Hydrochloride
Dosage: 1400 mg iv
Indication: Neuroblastoma
Start date: 2012-08-06
Gemcitabine Hydrochloride
Dosage: 1400 mg iv
Indication: Neuroblastoma
Start date: 2012-08-13
Other drugs received by patient: Neutraphos; Oxycontin; Bactrim; Lortab PRN; Citracal D; Zofran
Possible Proleukin side effects in male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-16
Patient: male, weighing 41.7 kg (91.7 pounds)
Reactions: Abdominal Pain, Vomiting, Bone Pain, Pancreatitis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Proleukin
Dosage: 4.5 miu on days 0-4
Indication: Neuroblastoma
Start date: 2012-07-23
End date: 2012-07-27
Zoledronic Acid
Dosage: 4 mg, iv on day 0
Indication: Neuroblastoma
Start date: 2012-07-23
Other drugs received by patient: Gemcitabine Hydrochloride; Lortab PRN; Zofran; Neutraphos; Irinotecan Hydrochloride; Bactrim; Oxycontin; Citracal D; Oxaliplatin
Possible Proleukin side effects in 85 year old male
Reported by a health professional (non-physician/pharmacist) from Japan on 2012-07-17
Patient: 85 year old male
Reactions: Respiratory Failure, Pleural Effusion, Ascites
Adverse event resulted in: death
Drug(s) suspected as cause:
Proleukin
Indication: Angiosarcoma
Proleukin
Docetaxel
Indication: Angiosarcoma
Docetaxel
Possible Proleukin side effects in 74 year old male
Reported by a physician from Japan on 2012-07-13
Patient: 74 year old male
Reactions: Interstitial Lung Disease, Hyperglycaemia, Sepsis, Enterocolitis, Metastases To Lung
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Proleukin
Dosage: unk
Indication: Metastatic Renal Cell Carcinoma
Everolimus (Everolimus)
Dosage: 10 mg, qd, po
Administration route: Oral
Indication: Renal Cell Carcinoma
Start date: 2010-09-30
Other drugs received by patient: Teceleukin; Allopurinol; Ingterferon Alfa; Sorafenib Tosilate; Sunitinib Malate; Paxil; Crestor
Possible Proleukin side effects in 67 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-18
Patient: 67 year old female
Reactions: Corneal Light Reflex Test Abnormal, Renal Cell Carcinoma, Unresponsive To Stimuli, Mental Status Changes, Hepatic Failure, Neoplasm Progression, Acidosis, Peripheral Ischaemia, Capillary Leak Syndrome, Multi-Organ Failure, Metastases To Adrenals, Vasoconstriction, Pulmonary Oedema, Electrolyte Imbalance, Pupil Fixed, Acute Respiratory Failure, Thrombocytopenia, Diarrhoea Infectious, Clostridial Infection, Metastases To Lung, Renal Failure Acute, Nodal Arrhythmia, Intestinal Ischaemia, Metabolic Acidosis, Hyponatraemia, Areflexia, Cardiac Arrest, Shock, Infection
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Proleukin
Other drugs received by patient: Amlodipine; Docusate Sodium; Omeprazole; Zolpidem; Glimepiride; Norco; Simvastatin; Acetylsalicylic Acid SRT; Lisinopril; Alprazolam; Atenolol; Metformin HCL
Possible Proleukin side effects in female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-07
Patient: female, weighing 48.5 kg (106.7 pounds)
Reactions: Myalgia, Hypotension, Tachycardia, Pyrexia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Zoledronic Acid
Dosage: 4 mg iv on day 0
Indication: Neuroblastoma
Start date: 2012-06-04
Proleukin
Dosage: 4.53 mil units sc d 0-4
Indication: Neuroblastoma
Start date: 2012-06-05
Proleukin
Dosage: 4.53 mil units sc d 0-4
Indication: Neuroblastoma
Start date: 2012-06-04
Other drugs received by patient: Diphenhydramine HCL; Oxycontin; Citracal D; Acetaminophen
Possible Proleukin side effects in 74 year old male
Reported by a individual with unspecified qualification from Japan on 2012-05-31
Patient: 74 year old male
Reactions: Interstitial Lung Disease, Sepsis, Hyperglycaemia, Neoplasm Progression, Enterocolitis, Metastatic Renal Cell Carcinoma
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Proleukin
Indication: Metastatic Renal Cell Carcinoma
Everolimus (Everolimus)
Dosage: 10 mg;qd;po
Administration route: Oral
Indication: Renal Cell Carcinoma
Start date: 2010-09-30
Other drugs received by patient: Allopurinol; Sorafenib Tosilate; Teceleukin; Paxil; Interferon Alfa; Crestor; Sunitinib Malate
Possible Proleukin side effects in 67 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-05-29
Patient: 67 year old female
Reactions: Unresponsive To Stimuli, Neoplasm Progression, Peripheral Ischaemia, Capillary Leak Syndrome, Oedema, Metastatic Renal Cell Carcinoma, Diarrhoea Infectious, Thrombocytopenia, Clostridial Infection, Acute Respiratory Failure, Renal Failure Acute, Intestinal Ischaemia, Metabolic Acidosis, Nodal Rhythm, Hyponatraemia, Dehydration, Cardiac Arrest, Shock, Infection
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Proleukin
Other drugs received by patient: Acetylsaliylic Acid; Alprazolam; Omeprazole; Amlodipine; Lisinopril; Metformin; Glimepiride; Norco; Zolpidem; Atenolol; Docusate Sodium; Simvastatin
Possible Proleukin side effects in female
Reported by a individual with unspecified qualification from United States on 2012-05-16
Patient: female, weighing 88.6 kg (194.9 pounds)
Reactions: Lymphocyte Count Decreased
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Proleukin
Possible Proleukin side effects in 51 year old female
Reported by a pharmacist from Spain on 2012-04-18
Patient: 51 year old female
Reactions: Eyelid Oedema, Urticaria Papular, Erythema
Drug(s) suspected as cause:
Proleukin
Dosage: 16 miu;qd;iv
Indication: Metastatic Malignant Melanoma
Start date: 2011-02-05
End date: 2011-02-08
Intron A
Dosage: 9 miu;qd;sc
Indication: Metastatic Malignant Melanoma
Start date: 2011-02-05
End date: 2011-02-08
Possible Proleukin side effects in 51 year old female
Reported by a pharmacist from Spain on 2012-04-17
Patient: 51 year old female
Reactions: Eyelid Oedema, Urticaria, Erythema
Drug(s) suspected as cause:
Intron A
Dosage: 9 miu;qd;sc
Indication: Product Used FOR Unknown Indication
Start date: 2011-02-05
End date: 2011-02-08
Proleukin
Dosage: 16 miu;qd;iv
Indication: Product Used FOR Unknown Indication
Start date: 2011-02-05
End date: 2011-02-08
Possible Proleukin side effects in 46 year old female
Reported by a physician from United States on 2012-04-11
Patient: 46 year old female, weighing 59.9 kg (131.8 pounds)
Reactions: Graft Versus Host Disease, Graft Versus Host Disease in Liver, Blood Glucose Increased
Drug(s) suspected as cause:
Proleukin
Other drugs received by patient: Lorazepam; Cholecalciferol; Ergocalciferol; Prednisone; Bactrim; Oxycodone HCL; Acyclovir; Ambien; Oxycontin; Levothyroxine Sodium; Tacrolimus; Voriconazole; Folic Acid; Zyprexa
Possible Proleukin side effects in 26 year old female
Reported by a physician from United States on 2012-04-11
Patient: 26 year old female, weighing 125.1 kg (275.2 pounds)
Reactions: Blood Glucose Increased
Drug(s) suspected as cause:
Proleukin
Other drugs received by patient: Actigall; Ambien; Citalopram; Lantus; Novolog; Dilaudid; Lovaza; Prednisone TAB; Zyprexa; Bactrim; Omeprazole; Tacrolimus; Acyclovir; Ativan; Pravastatin
Possible Proleukin side effects in female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-03-30
Patient: female
Reactions: Intestinal Ischaemia, Acidosis
Drug(s) suspected as cause:
Proleukin
Possible Proleukin side effects in
Reported by a physician from United States on 2012-03-22
Patient:
Reactions: Atrial Fibrillation
Drug(s) suspected as cause:
Proleukin
Possible Proleukin side effects in 24 year old male
Reported by a physician from United States on 2012-03-16
Patient: 24 year old male
Reactions: Dyspnoea, Hypotension
Drug(s) suspected as cause:
Proleukin
Other drugs received by patient: Tumor Infiltrating Lymphocytes
Possible Proleukin side effects in 54 year old male
Reported by a physician from United States on 2012-03-15
Patient: 54 year old male, weighing 121.2 kg (266.6 pounds)
Reactions: Blood Creatine Phosphokinase Increased, Cerebral Disorder, Tachycardia, Unresponsive To Stimuli, Mental Status Changes, Somnolence, Left Ventricular Dysfunction, Brain Oedema, Tachypnoea, Pathogen Resistance, Demyelination, Dyspnoea, Hypotension, Convulsive Threshold Lowered, Cogwheel Rigidity, Grand MAL Convulsion, Metabolic Encephalopathy, Klebsiella Test Positive
Adverse event resulted in: death, life threatening event, hospitalization
Drug(s) suspected as cause:
Mage Cells
Dosage: 78.8 x 10e9;
Indication: Malignant Melanoma
Start date: 2011-07-22
Proleukin
Dosage: 71.6 miu; q8h;iv
Indication: Metastatic Malignant Melanoma
Start date: 2011-07-22
End date: 2011-07-24
Possible Proleukin side effects in 55 year old male
Reported by a physician from Japan on 2012-03-07
Patient: 55 year old male
Reactions: Sepsis
Adverse event resulted in: death
Drug(s) suspected as cause:
Nexavar
Dosage: daily dose 800 mg/d
Administration route: Oral
Indication: Angiosarcoma
Paclitaxel
Dosage: combination with sorafenib
Docetaxel
Dosage: 15 courses 25-30 mg/m2
Indication: Angiosarcoma
Paclitaxel
Dosage: 6 courses 60-80 mg/m2
Indication: Angiosarcoma
Proleukin
Dosage: 134 local injections at 350 mu
Indication: Angiosarcoma
Possible Proleukin side effects in 71 year old female
Reported by a consumer/non-health professional from United States on 2012-02-03
Patient: 71 year old female
Reactions: Unresponsive To Stimuli, Mental Status Changes, Neoplasm Progression, Parkinsonism, Death, Oedema Peripheral, Pleural Effusion, Use of Accessory Respiratory Muscles, Axonal Neuropathy, Blood Creatinine Increased, Blood Pressure Systolic Decreased, Dyspnoea, Hypotension, Axillary Vein Thrombosis, Subclavian Vein Thrombosis, Renal Failure, Neoplasm Malignant, Cerebral Infarction, Infection
Adverse event resulted in: death, life threatening event, hospitalization
Drug(s) suspected as cause:
Proleukin
Other drugs received by patient: Fludarabine; Cytoxan
Possible Proleukin side effects in 71 year old female
Reported by a physician from United States on 2012-01-31
Patient: 71 year old female
Reactions: Unresponsive To Stimuli, Mental Status Changes, Neoplasm Progression, Somnolence, Vena Cava Thrombosis, Corneal Reflex Decreased, Oedema, Pleural Effusion, Use of Accessory Respiratory Muscles, Diffuse Axonal Injury, Blood Creatinine Increased, Hypotension, Oesophageal Carcinoma, Tremor, Haemodialysis, Renal Failure, Cerebral Infarction, Infection
Adverse event resulted in: death, life threatening event, hospitalization
Drug(s) suspected as cause:
Proleukin
Possible Proleukin 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 Proleukin 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 Proleukin side effects in 46 year old male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-01-03
Patient: 46 year old male, weighing 106.0 kg (233.2 pounds)
Reactions: Metastatic Malignant Melanoma, Alanine Aminotransferase Increased, Chromaturia, Pyrexia, Renal Impairment, Neoplasm Malignant, Aspartate Aminotransferase Increased, Liver Function Test Abnormal, Dizziness, Rash Maculo-Papular
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Vemurafenib
Start date: 2011-12-06
End date: 2011-12-13
Cyclophosphamide
Indication: Metastatic Malignant Melanoma
Start date: 2011-10-31
Proleukin
Indication: Metastatic Malignant Melanoma
Start date: 2011-11-02
End date: 2011-11-16
Ipilimumab
Dosage: also on 11mar2011 and 22nov2011.
Indication: Metastatic Malignant Melanoma
Start date: 2011-10-04
Possible Proleukin side effects in 39 year old female
Reported by a health professional (non-physician/pharmacist) from France on 2011-12-28
Patient: 39 year old female
Reactions: Injection Site Inflammation, Roseola, Immune System Disorder, Herpes Virus Infection
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Proleukin
Possible Proleukin side effects in 45 year old female
Reported by a physician from United States on 2011-12-27
Patient: 45 year old female, weighing 58.3 kg (128.3 pounds)
Reactions: Bronchopulmonary Aspergillosis, Pseudomonas Test Positive, Treatment Noncompliance, Pulmonary Cavitation
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Proleukin
Other drugs received by patient: Citalopram; Famotidine; Zoledronic Acid; Hydrocodone; Lorazepam; Prednisone; Bactrim; Flovent; Sirolimus; Acyclovir; Folic Acid; Norvasc; Azithromycin; Mycophenolate Mofetil (Cellcept); Voriconazole
Possible Proleukin side effects in 65 year old male
Reported by a physician from France on 2011-12-22
Patient: 65 year old male
Reactions: Anal Abscess
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Acetaminophen
Indication: Product Used FOR Unknown Indication
Proleukin
Dosage: iv
Indication: Malignant Melanoma
Start date: 2011-11-21
End date: 2011-12-04
Possible Proleukin side effects in male
Reported by a physician from France on 2011-11-28
Patient: male, weighing 108.0 kg (237.6 pounds)
Reactions: Nausea, Pain in Extremity, Oedema Peripheral, Asthenia, Deep Vein Thrombosis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Maraviroc
Dosage: 300mg per day
Administration route: Oral
Indication: HIV Infection
Start date: 2011-02-09
Isentress
Dosage: 800mg per day
Administration route: Oral
Indication: HIV Infection
Start date: 2011-02-09
Proleukin
Indication: HIV Infection
Start date: 2011-04-05
End date: 2011-04-19
Other drugs received by patient: Abacavir Sulfate; Prezista; Norvir; Aspegic 325
Possible Proleukin side effects in 43 year old male
Reported by a physician from United States on 2011-11-23
Patient: 43 year old male
Reactions: Metastasis, Death
Adverse event resulted in: death
Drug(s) suspected as cause:
Proleukin
Possible Proleukin side effects in 60 year old female
Reported by a health professional (non-physician/pharmacist) from Denmark on 2011-11-17
Patient: 60 year old female
Reactions: Pain, Drug Intolerance, Hypoaesthesia, Paraesthesia
Drug(s) suspected as cause:
Proleukin
Possible Proleukin side effects in male
Reported by a physician from France on 2011-11-16
Patient: male, weighing 108.0 kg (237.6 pounds)
Reactions: Pain in Extremity, Nausea, Oedema Peripheral, Asthenia, Deep Vein Thrombosis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Proleukin
Indication: HIV Infection
Start date: 2011-04-05
End date: 2011-04-19
Isentress
Dosage: 800mg per day
Administration route: Oral
Indication: HIV Infection
Start date: 2011-02-09
Maraviroc
Dosage: 300mg per day
Administration route: Oral
Indication: HIV Infection
Start date: 2011-02-09
Other drugs received by patient: Aspegic 325; Kivexa; Norvir; Prezista
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