Index of reports
> Life Threatening Events (22)
Below is the selection of side effect reports (a.k.a. adverse event reports) related to Ilaris (Canakinumab) life threatening events. The selected reports were submitted to the FDA during the sample period of about a year.
Possible Ilaris side effects in female
Reported by a health professional (non-physician/pharmacist) from Norway on 2012-08-23
Patient: female
Reactions: Parvovirus Infection, Histiocytosis Haematophagic, General Physical Health Deterioration, Pyrexia, Rash, Serum Ferritin Increased, Bone Marrow Disorder, Thrombocytopenia, Leukopenia
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Ilaris
Other drugs received by patient: Methotrexate; Prednisolone; Calcigran; Omeprazole (Prisolec); Folic Acid
Possible Ilaris side effects in female
Reported by a health professional (non-physician/pharmacist) from Norway on 2012-08-13
Patient: female
Reactions: Parvovirus Infection, Histiocytosis Haematophagic, General Physical Health Deterioration, Rash, Pyrexia, Serum Ferritin Increased, Bone Marrow Disorder, Thrombocytopenia, Leukopenia
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Ilaris
Dosage: 150 mg (dose was reduced to half)
Ilaris
Dosage: 300 mg every 4th week
Indication: Juvenile Arthritis
Start date: 2011-05-01
Other drugs received by patient: Calcigran; Folic Acid; Omeprazole (Prisolec); Prednisolone; Methotrexate
Possible Ilaris side effects in male
Reported by a physician from United States on 2012-07-23
Patient: male, weighing 73.0 kg (160.6 pounds)
Reactions: Respiratory Failure, Interstitial Lung Disease, Anaemia, Coagulopathy, Hypokalaemia
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Amiodarone HCL
Dosage: 400 mg, qd
Administration route: Oral
Indication: Atrial Fibrillation
Start date: 2012-01-20
End date: 2012-06-07
Xarelto
Dosage: 20 mg, qd
Administration route: Oral
Indication: Atrial Fibrillation
Start date: 2011-12-30
End date: 2012-06-07
Ilaris
Dosage: unk
Administration route: Oral
Indication: Cardiovascular Event Prophylaxis
Start date: 2011-07-08
End date: 2012-04-23
Other drugs received by patient: Aspirin; Lisinopril; Carvedilol; Potassium Chloride; Lipitor; Lasix
Possible Ilaris side effects in female
Reported by a physician from Israel on 2012-07-23
Patient: female, weighing 17.0 kg (37.4 pounds)
Reactions: Device Related Sepsis, Histiocytosis Haematophagic, Pneumonia, Gastroenteritis, Septic Shock, Peritonitis
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Ilaris
Other drugs received by patient: Amoxicillin; Iron; Methylprednisolone; Methotrexate; Vitamin D
Possible Ilaris side effects in male
Reported by a physician from United States on 2012-07-10
Patient: male, weighing 104.3 kg (229.5 pounds)
Reactions: Bladder Cancer
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Ilaris
Dosage: double blinded
Start date: 2011-09-09
Placebo
Dosage: double blinded
Indication: Gouty Arthritis
Start date: 2011-09-09
Triamcinolone Acetonide
Dosage: double blinded
Indication: Gouty Arthritis
Start date: 2011-09-09
Blinded NO Treatment Received
Dosage: double blinded
Indication: Gouty Arthritis
Start date: 2011-09-09
Ilaris
Dosage: double blinded
Indication: Gouty Arthritis
Start date: 2011-09-09
Other drugs received by patient: Remeron; Depakote; Allopurinol; Colchicine; Losartan Potassium; Risperdal
Possible Ilaris side effects in male
Reported by a physician from United States on 2012-06-21
Patient: male, weighing 73.0 kg (160.6 pounds)
Reactions: Interstitial Lung Disease, Respiratory Failure, Anaemia, Coagulopathy, Hypokalaemia
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Amiodarone HCL
Dosage: 400 mg, qd
Administration route: Oral
Indication: Atrial Fibrillation
Start date: 2012-01-20
End date: 2012-06-07
Ilaris
Dosage: unk
Administration route: Oral
Indication: Cardiovascular Event Prophylaxis
Start date: 2011-07-08
End date: 2012-04-23
Other drugs received by patient: Lisinopril; Potassium Chloride; Carvedilol; Aspirin; Lipitor; Xarelto; Lasix
Possible Ilaris side effects in male
Reported by a physician from United States on 2012-06-20
Patient: male, weighing 73.0 kg (160.6 pounds)
Reactions: Interstitial Lung Disease, Respiratory Failure, Coagulopathy, Anaemia, Hypokalaemia
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Ilaris
Dosage: unk
Administration route: Oral
Indication: Cardiovascular Event Prophylaxis
Start date: 2011-07-08
End date: 2012-04-23
Amiodarone HCL
Dosage: 400 mg, qd
Administration route: Oral
Indication: Atrial Fibrillation
Start date: 2012-01-20
End date: 2012-06-07
Other drugs received by patient: Lisinopril; Aspirin; Carvedilol; Xarelto; Lasix; Potassium Chloride; Lipitor
Possible Ilaris side effects in male
Reported by a physician from United States on 2012-06-15
Patient: male, weighing 73.0 kg (160.6 pounds)
Reactions: International Normalised Ratio Increased, Coagulopathy, Anaemia, Atrial Fibrillation, Disease Progression, Hypokalaemia, Respiratory Failure, Interstitial Lung Disease, Blood Glucose Increased
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Amiodarone HCL
Dosage: 400 mg, qd
Administration route: Oral
Indication: Atrial Fibrillation
Start date: 2012-01-20
End date: 2012-06-07
Ilaris
Dosage: unk
Administration route: Oral
Indication: Cardiovascular Event Prophylaxis
Start date: 2011-07-08
End date: 2012-04-23
Other drugs received by patient: Carvedilol; Xarelto; Aspirin; Potassium Chloride; Lasix; Lisinopril; Lipitor
Possible Ilaris side effects in male
Reported by a physician from United States on 2012-06-15
Patient: male, weighing 73.0 kg (160.6 pounds)
Reactions: Respiratory Failure, Interstitial Lung Disease, Coagulopathy, Anaemia, Hypokalaemia
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Ilaris
Dosage: unk
Administration route: Oral
Indication: Cardiovascular Event Prophylaxis
Start date: 2011-07-08
End date: 2012-04-23
Amiodarone HCL
Dosage: 400 mg, qd
Administration route: Oral
Indication: Atrial Fibrillation
Start date: 2012-01-20
End date: 2012-06-07
Other drugs received by patient: Lisinopril; Lipitor; Potassium Chloride; Xarelto; Carvedilol; Aspirin; Lasix
Possible Ilaris side effects in female
Reported by a physician from Israel on 2012-06-04
Patient: female, weighing 17.0 kg (37.4 pounds)
Reactions: Gastroenteritis, Septic Shock, Peritonitis
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Ilaris
Other drugs received by patient: Vitamin D; Amoxicillin; Iron; Methylprednisolone; Methotrexate
Possible Ilaris side effects in female
Reported by a physician from Israel on 2012-05-24
Patient: female, weighing 17.0 kg (37.4 pounds)
Reactions: Gastroenteritis, Septic Shock, Peritonitis
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Ilaris
Other drugs received by patient: Methylprednisolone; Vitamin D; Amoxicillin; Iron; Methotrexate
Possible Ilaris side effects in female
Reported by a physician from United States on 2012-05-15
Patient: female, weighing 90.3 kg (198.7 pounds)
Reactions: Overdose, Palpitations, Angina Unstable, Suicide Attempt, Concomitant Disease Progression, Suicidal Ideation
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Blinded NO Treatment Received
Dosage: double blinded
Indication: Cardiovascular Event Prophylaxis
Start date: 2011-06-23
Klonopin
Dosage: weekly
Indication: Anxiety
Start date: 2011-08-18
Metoprolol Succinate Extended Release
Dosage: 50 mg, bid
Administration route: Oral
Start date: 2012-05-01
Placebo
Dosage: double blinded
Indication: Cardiovascular Event Prophylaxis
Start date: 2011-06-23
Metoprolol Succinate Extended Release
Dosage: 25 mg, bid
Administration route: Oral
Start date: 2011-06-17
End date: 2012-04-30
Ilaris
Dosage: double blinded
Indication: Cardiovascular Event Prophylaxis
Start date: 2011-06-23
Other drugs received by patient: Trazodone HCL; Buspar; Aspirin; Trazodone HCL; Effexor; Effexor; Effexor; Effexor; Buspar
Possible Ilaris side effects in male
Reported by a physician from United States on 2012-05-11
Patient: male, weighing 115.3 kg (253.7 pounds)
Reactions: Cellulitis, Beta Haemolytic Streptococcal Infection, Sepsis
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Ilaris
Other drugs received by patient: Simvastatin; Effient; Lisinopril; Bystolic; Niaspan; Zocor; Aspirin
Possible Ilaris side effects in female
Reported by a physician from United States on 2012-05-08
Patient: female, weighing 90.3 kg (198.7 pounds)
Reactions: Overdose, Palpitations, Angina Unstable, Suicide Attempt, Concomitant Disease Progression, Suicidal Ideation
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Klonopin
Dosage: weekly
Indication: Anxiety
Start date: 2011-08-18
Placebo
Dosage: double blinded
Indication: Cardiovascular Event Prophylaxis
Start date: 2011-06-23
Ilaris
Dosage: double blinded
Indication: Cardiovascular Event Prophylaxis
Start date: 2011-06-23
Blinded NO Treatment Received
Dosage: double blinded
Indication: Cardiovascular Event Prophylaxis
Start date: 2011-06-23
Metoprolol Succinate Extended Release
Dosage: 25 mg, bid
Administration route: Oral
Start date: 2011-06-17
End date: 2012-04-30
Metoprolol Succinate Extended Release
Dosage: 50 mg, bid
Administration route: Oral
Start date: 2012-05-01
Other drugs received by patient: Buspar; Buspar; Effexor; Effexor; Trazodone HCL; Aspirin; Effexor
Possible Ilaris side effects in male
Reported by a physician from Turkey on 2012-03-12
Patient: male, weighing 32.0 kg (70.4 pounds)
Reactions: Histiocytosis Haematophagic
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Ilaris
Dosage: 0.80 ml, unk
Indication: Juvenile Arthritis
Start date: 2011-11-30
Ilaris
Dosage: 0.86 ml, unk
Start date: 2011-12-26
Ilaris
Dosage: 0.88 ml, unk
Start date: 2012-02-22
Ilaris
Dosage: 0.85 ml, unk
Start date: 2012-01-23
Possible Ilaris side effects in male
Reported by a physician from Turkey on 2012-03-09
Patient: male, weighing 32.0 kg (70.4 pounds)
Reactions: Histiocytosis Haematophagic
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Ilaris
Dosage: 0.80 ml, unk
Indication: Juvenile Arthritis
Start date: 2011-11-30
Ilaris
Dosage: 0.85 ml, unk
Start date: 2012-01-23
Ilaris
Dosage: 0.88 ml, unk
Start date: 2012-02-22
Ilaris
Dosage: 0.86 ml, unk
Start date: 2011-12-26
Possible Ilaris side effects in male
Reported by a physician from Turkey on 2012-03-05
Patient: male, weighing 32.0 kg (70.4 pounds)
Reactions: Viral Infection, Histiocytosis Haematophagic
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Ilaris
Dosage: 0.86 ml, unk
Start date: 2011-12-26
Ilaris
Dosage: 0.85 ml, unk
Start date: 2012-01-23
Ilaris
Dosage: 0.80 ml, unk
Indication: Juvenile Arthritis
Start date: 2011-11-30
Ilaris
Dosage: 0.88 ml, unk
Start date: 2012-02-22
Possible Ilaris side effects in male
Reported by a physician from United States on 2012-03-02
Patient: male, weighing 115.3 kg (253.7 pounds)
Reactions: Cellulitis, Beta Haemolytic Streptococcal Infection, Sepsis
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Ilaris
Other drugs received by patient: Zocor; Lisinopril; Bystolic; Aspirin; Simvastatin; Effient; Niaspan
Possible Ilaris side effects in female
Reported by a physician from United States on 2012-01-20
Patient: female, weighing 90.3 kg (198.7 pounds)
Reactions: Overdose, Suicide Attempt, Concomitant Disease Progression
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Klonopin
Dosage: weekly
Indication: Anxiety
Start date: 2011-08-18
Metoprolol Succinate Extended Release
Ilaris
Dosage: double blinded
Indication: Cardiovascular Event Prophylaxis
Start date: 2011-06-23
Blinded NO Treatment Received
Dosage: double blinded
Indication: Cardiovascular Event Prophylaxis
Start date: 2011-06-23
Blinded Placebo
Dosage: double blinded
Indication: Cardiovascular Event Prophylaxis
Start date: 2011-06-23
Other drugs received by patient: Effexor; Effexor; Effexor
Possible Ilaris side effects in female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-01-05
Patient: female, weighing 90.3 kg (198.7 pounds)
Reactions: Overdose, Suicide Attempt, Concomitant Disease Progression
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Ilaris
Dosage: double blinded
Indication: Cardiovascular Event Prophylaxis
Start date: 2011-06-23
Blinded NO Treatment Received
Dosage: double blinded
Indication: Cardiovascular Event Prophylaxis
Start date: 2011-06-23
Metoprolol Succinate Extended Release
Placebo
Dosage: double blinded
Indication: Cardiovascular Event Prophylaxis
Start date: 2011-06-23
Klonopin
Dosage: weekly
Indication: Anxiety
Start date: 2011-08-18
Other drugs received by patient: Effexor; Effexor
Possible Ilaris side effects in male
Reported by a consumer/non-health professional from United States on 2011-12-21
Patient: male, weighing 115.3 kg (253.7 pounds)
Reactions: Cellulitis, Sepsis
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Ilaris
Other drugs received by patient: Zocor; Effient; Lisinopril; Simvastatin; Niaspan; Aspirin; Bystolic
Possible Ilaris side effects in male
Reported by a physician from United States on 2011-10-13
Patient: male, weighing 70.7 kg (155.5 pounds)
Reactions: Productive Cough, Pneumonia, Wheezing, Disease Progression, Fatigue, Dyspnoea Exertional, Respiratory Failure, Pulmonary Congestion, Sputum Discoloured, Lung Infiltration, Asthenia
Adverse event resulted in: death, life threatening event, hospitalization
Drug(s) suspected as cause:
Ilaris
Other drugs received by patient: Stool Softener; Flomax; Prednisone; Lasix; Vitamin D; Fish OIL; Theophylline; Spiriva; Advair Diskus 100 / 50
|