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Proleukin (Aldesleukin) - Side Effect Reports to FDA

 
 



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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