This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Ilaris (Canakinumab) 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 (332)
Death (9)
Life Threatening Events (22)
Disability (2)
Reports by Reaction Type
Pyrexia (38),
Drug Ineffective (27),
Arthralgia (24),
Headache (23),
Rash (21),
Pneumonia (19),
Histiocytosis Haematophagic (19),
Condition Aggravated (19),
Vomiting (13),
Concomitant Disease Progression (13),
Pain (12),
Erythema (12)
Below are a few examples of reports where side effects / adverse reactions may be related to Ilaris (Canakinumab). For a complete list or a specific selection of reports, please use the links above.
Possible Ilaris side effects in male
Reported by a physician from Germany on 2012-08-24
Patient: male, weighing 15.2 kg (33.4 pounds)
Reactions: Sepsis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Ilaris
Dosage: 60.3 mg, unk
Indication: Juvenile Arthritis
Start date: 2012-05-14
Prednisolone
Possible Ilaris side effects in female
Reported by a consumer/non-health professional from United States on 2012-08-24
Patient: female
Reactions: Hypokinesia, Pain in Extremity, Arthralgia, Chest Pain, Urticaria, Pyrexia, Enuresis
Drug(s) suspected as cause:
Ilaris
Possible Ilaris side effects in female
Reported by a consumer/non-health professional from United States on 2012-08-24
Patient: female
Reactions: Pruritus, Urticaria, Rhinorrhoea, Oropharyngeal Pain, Pyrexia, Rash, Insomnia, Dizziness
Drug(s) suspected as cause:
Ilaris
Other drugs received by patient: Armodafinil
Possible Ilaris side effects in male
Reported by a physician from United Kingdom on 2012-08-24
Patient: male, weighing 74.8 kg (164.6 pounds)
Reactions: Pneumonia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Ilaris
Other drugs received by patient: Acetaminophen
Possible Ilaris side effects in
Reported by a consumer/non-health professional from United Kingdom on 2012-08-24
Patient:
Reactions: Pneumonia
Drug(s) suspected as cause:
Ilaris
Possible Ilaris side effects in female
Reported by a physician from France on 2012-08-24
Patient: female, weighing 12.0 kg (26.4 pounds)
Reactions: Histiocytosis Haematophagic
Drug(s) suspected as cause:
Ilaris
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 male
Reported by a physician from United States on 2012-08-23
Patient: male, weighing 74.8 kg (164.6 pounds)
Reactions: Cerumen Impaction, Gastritis Erosive, Dizziness, Mastoiditis, Erosive Duodenitis, Gastric Ulcer, non-Cardiac Chest Pain
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Acetylsalicylic Acid SRT
Dosage: 81 mg, qd
Administration route: Oral
Indication: Cardiovascular Event Prophylaxis
Start date: 2008-01-01
End date: 2011-11-27
Blinded NO Treatment Received
Dosage: double blinded
Indication: Cardiovascular Event Prophylaxis
Start date: 2011-07-21
Ilaris
Dosage: double blinded
Indication: Cardiovascular Event Prophylaxis
Start date: 2011-07-21
Placebo
Dosage: double blinded
Indication: Cardiovascular Event Prophylaxis
Start date: 2011-07-21
Other drugs received by patient: Plavix
Possible Ilaris side effects in male
Reported by a physician from United States on 2012-08-23
Patient: male, weighing 74.8 kg (164.6 pounds)
Reactions: Cerumen Impaction, Gastritis Erosive, Dizziness, non-Cardiac Chest Pain, Erosive Duodenitis, Gastric Ulcer, Mastoiditis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Acetylsalicylic Acid SRT
Dosage: 81 mg, qd
Administration route: Oral
Indication: Cardiovascular Event Prophylaxis
Start date: 2008-01-01
End date: 2011-11-27
Blinded NO Treatment Received
Dosage: double blinded
Indication: Cardiovascular Event Prophylaxis
Start date: 2011-07-21
Ilaris
Dosage: double blinded
Indication: Cardiovascular Event Prophylaxis
Start date: 2011-07-21
Placebo
Dosage: double blinded
Indication: Cardiovascular Event Prophylaxis
Start date: 2011-07-21
Other drugs received by patient: Plavix
Possible Ilaris side effects in female
Reported by a physician from Germany on 2012-08-22
Patient: female, weighing 63.0 kg (138.6 pounds)
Reactions: Glaucoma, Intracranial Pressure Increased, Meningitis, Postictal State, Epilepsy
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Ilaris
Dosage: 300 mg, 5 weekly
Start date: 2011-11-01
End date: 2012-02-06
Ilaris
Dosage: 300 mg for every 8 weeks
Indication: Chronic Infantile Neurological Cutaneous and Articular Syndrome
Start date: 2010-06-01
Other drugs received by patient: Kineret; Lyrica; Aspirin; Clonid-Ophtal; Dipiperon; Trental; Prednisone TAB; Predni; Interleukin-1; Lumigan; Perilax; Venlafaxine; Timo-Comod; Beclometasone Dipropionate W / Formoterol Fumarate; Prednisone TAB; Cosopt
Possible Ilaris side effects in male
Reported by a physician from United States on 2012-08-22
Patient: male, weighing 78.0 kg (171.6 pounds)
Reactions: Renal Failure Acute
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Blinded NO Treatment Received
Dosage: code not broken
Indication: Cardiovascular Event Prophylaxis
Start date: 2011-09-29
End date: 2012-06-29
Ibuprofen
Ilaris
Dosage: code not broken
Indication: Cardiovascular Event Prophylaxis
Start date: 2011-09-29
End date: 2012-06-29
Lasix
Dosage: 40 mg, qd
Start date: 2011-08-01
End date: 2012-03-29
Losartan Potassium
Dosage: 25 mg, bid
Start date: 2011-12-01
End date: 2012-03-29
Metformin HCL
Dosage: 1000 mg, bid
Start date: 2011-09-01
End date: 2012-03-29
Omeprazole
Dosage: 20 mg, qd
Indication: Gastrooesophageal Reflux Disease
Start date: 2011-09-01
End date: 2012-03-29
Placebo
Dosage: code not broken
Indication: Cardiovascular Event Prophylaxis
Start date: 2011-09-29
End date: 2012-06-29
Spironolactone
Dosage: 25 mg, qd
Start date: 2011-08-01
End date: 2012-03-29
Victoza
Dosage: unk
Indication: Type 2 Diabetes Mellitus
Start date: 2012-02-14
End date: 2012-03-24
Other drugs received by patient: Crestor; Aspirin; Potassium; Carvedilol; Multi-Vitamins
Possible Ilaris side effects in female
Reported by a physician from Germany on 2012-08-22
Patient: female, weighing 61.1 kg (134.4 pounds)
Reactions: Meningitis, Intracranial Pressure Increased, Epilepsy, Postictal State
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Ilaris
Dosage: 300 mg, 5 weekly
Start date: 2011-11-01
End date: 2012-02-06
Ilaris
Dosage: 300 mg, for every 8 weeks
Indication: Chronic Infantile Neurological Cutaneous and Articular Syndrome
Start date: 2010-06-01
Other drugs received by patient: Trental; Dipiperon; Perilax; Lyrica; Beclometasone Dipropionate W / Formoterol Fumarate; Interleukin-1; Kineret; Prednisone TAB; Prednisone TAB; Corticosteroids; Venlafaxine; Aspirin
Possible Ilaris side effects in male
Reported by a physician from United States on 2012-08-22
Patient: male, weighing 78.0 kg (171.6 pounds)
Reactions: Renal Failure Acute
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Blinded NO Treatment Received
Dosage: code not broken
Indication: Cardiovascular Event Prophylaxis
Start date: 2011-09-29
End date: 2012-06-29
Ibuprofen
Ilaris
Dosage: code not broken
Indication: Cardiovascular Event Prophylaxis
Start date: 2011-09-29
End date: 2012-06-29
Lasix
Dosage: 40 mg, qd
Start date: 2011-08-01
End date: 2012-03-29
Losartan Potassium
Dosage: 25 mg, bid
Start date: 2011-12-01
End date: 2012-03-29
Metformin
Dosage: 1000 mg, bid
Start date: 2011-09-01
End date: 2012-03-29
Omeprazole
Dosage: 20 mg, qd
Indication: Gastrooesophageal Reflux Disease
Start date: 2011-09-01
End date: 2012-03-29
Placebo
Dosage: code not broken
Indication: Cardiovascular Event Prophylaxis
Start date: 2011-09-29
End date: 2012-06-29
Spironolactone
Dosage: 25 mg, qd
Start date: 2011-08-01
End date: 2012-03-29
Victoza
Dosage: unk
Indication: Type 2 Diabetes Mellitus
Start date: 2012-02-14
End date: 2012-03-24
Other drugs received by patient: Aspirin; Carvedilol; Multi-Vitamins; Potassium; Crestor
Possible Ilaris side effects in male
Reported by a health professional (non-physician/pharmacist) from Germany on 2012-08-22
Patient: male, weighing 15.2 kg (33.4 pounds)
Reactions: Sepsis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Ilaris
Possible Ilaris side effects in male
Reported by a physician from Norway on 2012-08-22
Patient: male, weighing 18.6 kg (40.9 pounds)
Reactions: Injection Site Erythema, Pain in Extremity, Intracranial Pressure Increased, Pyrexia, Injection Site Swelling, Erysipelas, Papilloedema
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Ilaris
Dosage: 75 mg every 8 weeks
Indication: Chronic Infantile Neurological Cutaneous and Articular Syndrome
Start date: 2010-02-15
Ilaris
Indication: Cryopyrin Associated Periodic Syndrome
Other drugs received by patient: Penicillin; Dicloxacillin; Penicillin; Penicillin
Possible Ilaris side effects in male
Reported by a pharmacist from France on 2012-08-22
Patient: male, weighing 35.0 kg (77.0 pounds)
Reactions: Inappropriate Schedule of Drug Administration, Abdominal Pain, Arthralgia, Pyrexia
Drug(s) suspected as cause:
Ilaris
Other drugs received by patient: Colchicine; Colchicine Opacalcium
Possible Ilaris side effects in male
Reported by a physician from United Kingdom on 2012-08-17
Patient: male
Reactions: Diabetes Mellitus, Oedema Peripheral
Drug(s) suspected as cause:
Ilaris
Possible Ilaris side effects in female
Reported by a physician from Germany on 2012-08-17
Patient: female, weighing 56.0 kg (123.2 pounds)
Reactions: Metastases To Lymph Nodes, Metastases To Central Nervous System, Metastases To Lung, Rectal Cancer Metastatic, Decreased Appetite
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Ilaris
Other drugs received by patient: Novalgin; Aspirin; Bisoprolol Fumarate; Granisetron Hydrochloride; Buprenorphine; Xipamide; Omeprazole; Simvastatin; Torsemide; Torsemide; Insidon; Pantoprazole; Morphine; Decadron
Possible Ilaris side effects in female
Reported by a health professional (non-physician/pharmacist) from France on 2012-08-17
Patient: female, weighing 33.0 kg (72.6 pounds)
Reactions: Blood Bilirubin Increased, Jaundice, Autoimmune Hepatitis, Necrosis, Cytolytic Hepatitis, Growth Retardation, Cholestasis, Transaminases Increased, Cholangitis, Ocular Icterus, Prothrombin Level Decreased
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Ilaris
Other drugs received by patient: Methotrexate; Naproxen; Unspecified Growth Hormones; Prednisone TAB; Acetaminophen
Possible Ilaris side effects in male
Reported by a physician from Sweden on 2012-08-16
Patient: male, weighing 102.7 kg (225.9 pounds)
Reactions: Sepsis, Cardiac Arrest
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Ilaris
Dosage: 300 mg, unk
Start date: 2012-05-15
Ilaris
Dosage: 300 mg, unk
Indication: Cardiovascular Event Prophylaxis
Start date: 2012-05-02
End date: 2012-05-02
Other drugs received by patient: Rosuvastatin; Aspirin; Bisoprolol; Furoside; Carvedilol
Possible Ilaris side effects in female
Reported by a physician from Germany on 2012-08-16
Patient: female, weighing 61.1 kg (134.4 pounds)
Reactions: Meningitis, Intracranial Pressure Increased, Epilepsy, Postictal State
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Ilaris
Dosage: 300 mg, 5 weekly
Start date: 2011-11-01
End date: 2012-02-06
Ilaris
Dosage: 300 mg, for every 8 weeks
Indication: Chronic Infantile Neurological Cutaneous and Articular Syndrome
Start date: 2010-06-01
Other drugs received by patient: Kineret; Dipiperon; Trental; Lyrica; Beclometasone Dipropionate W / Formoterol Fumarate; Perilax; Prednisone TAB; Prednisone TAB; Aspirin; Corticosteroids; Interleukin-1; Venlafaxine
Possible Ilaris side effects in 11 year old male
Reported by a physician from United States on 2012-08-16
Patient: 11 year old male, weighing 27.7 kg (60.9 pounds)
Reactions: Abdominal Pain, Vomiting, Pyrexia, Gastrointestinal Obstruction
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Ilaris
Possible Ilaris side effects in male
Reported by a health professional (non-physician/pharmacist) from Germany on 2012-08-16
Patient: male, weighing 93.0 kg (204.6 pounds)
Reactions: Productive Cough, Dyspnoea, Pneumonia, Pyrexia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Ilaris
Possible Ilaris side effects in female
Reported by a physician from France on 2012-08-16
Patient: female, weighing 12.0 kg (26.4 pounds)
Reactions: Histiocytosis Haematophagic
Drug(s) suspected as cause:
Ilaris
Possible Ilaris side effects in male
Reported by a physician from United States on 2012-08-15
Patient: male, weighing 78.0 kg (171.6 pounds)
Reactions: Renal Failure Acute
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Blinded NO Treatment Received
Dosage: code not broken
Indication: Cardiovascular Event Prophylaxis
Start date: 2011-09-29
End date: 2012-06-29
Ibuprofen
Ilaris
Dosage: code not broken
Indication: Cardiovascular Event Prophylaxis
Start date: 2011-09-29
End date: 2012-06-29
Lasix
Dosage: 40 mg, qd
Start date: 2011-08-01
End date: 2012-03-29
Losartan Potassium
Dosage: 25 mg, bid
Start date: 2011-12-01
End date: 2012-03-29
Metformin Hydrochloride
Dosage: 1000 mg, bid
Start date: 2011-09-01
End date: 2012-03-29
Placebo
Dosage: code not broken
Indication: Cardiovascular Event Prophylaxis
Start date: 2011-09-29
End date: 2012-06-29
Spironolactone
Dosage: 25 mg, qd
Start date: 2011-08-01
End date: 2012-03-29
Victoza
Dosage: unk
Indication: Type 2 Diabetes Mellitus
Start date: 2012-02-14
End date: 2012-03-24
Other drugs received by patient: Multi-Vitamins; Carvedilol; Aspirin; Crestor; Omeprazole; Potassium
Possible Ilaris side effects in male
Reported by a physician from United States on 2012-08-15
Patient: male, weighing 78.0 kg (171.6 pounds)
Reactions: Renal Failure Acute
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Blinded NO Treatment Received
Dosage: code not broken
Indication: Cardiovascular Event Prophylaxis
Start date: 2011-09-29
End date: 2012-06-29
Ibuprofen
Ilaris
Dosage: code not broken
Indication: Cardiovascular Event Prophylaxis
Start date: 2011-09-29
End date: 2012-06-29
Lasix
Dosage: 40 mg, qd
Start date: 2011-08-01
End date: 2012-03-29
Losartan Potassium
Dosage: 25 mg, bid
Start date: 2011-12-01
End date: 2012-03-29
Metformin Hydrochloride
Dosage: 1000 mg, bid
Start date: 2011-09-01
End date: 2012-03-29
Placebo
Dosage: code not broken
Indication: Cardiovascular Event Prophylaxis
Start date: 2011-09-29
End date: 2012-06-29
Spironolactone
Dosage: 25 mg, qd
Start date: 2011-08-01
End date: 2012-03-29
Victoza
Dosage: unk
Indication: Type 2 Diabetes Mellitus
Start date: 2012-02-14
End date: 2012-03-24
Other drugs received by patient: Carvedilol; Crestor; Multi-Vitamins; Aspirin; Omeprazole; Potassium
Possible Ilaris side effects in male
Reported by a consumer/non-health professional from Japan on 2012-08-14
Patient: male
Reactions: Drug Effect Decreased, Vomiting, Contusion, Skin Exfoliation, Impetigo, Headache, Wound Secretion
Drug(s) suspected as cause:
Ilaris
Possible Ilaris side effects in female
Reported by a physician from United States on 2012-08-14
Patient: female, weighing 40.0 kg (88.0 pounds)
Reactions: Dizziness, Vertigo, Loss of Consciousness
Drug(s) suspected as cause:
Ilaris
Other drugs received by patient: Prednisone TAB; Tylenol; Coenzyme Q10
Possible Ilaris side effects in female
Reported by a health professional (non-physician/pharmacist) from Canada on 2012-08-13
Patient: female, weighing 27.2 kg (59.8 pounds)
Reactions: Impetigo, Gastroenteritis, Sinusitis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Amoxicillin and Clavulanate Potassium
Dosage: 200 / 500 mg q8h
Indication: Sinusitis
Start date: 2012-03-08
End date: 2012-03-08
Ilaris
Dosage: 4 mg/kg, unk
Indication: Juvenile Arthritis
Start date: 2010-01-12
Other drugs received by patient: Naproxen; Calcia; D-VI-SOL; Prevacid; Tylenol-Acetaminophene; Morphine; Morphine Sulfate; Tylenol-Acetaminophene; Pediapred; Folic Acid; Vitamin D; Methotrexate
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
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