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Ilaris (Canakinumab) - Side Effect Reports to FDA

 
 



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 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 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 2012-08-22

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 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 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 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 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 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 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 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

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