Canakinumab

Common brands: Ilaris, Kineret, Methotrexate, Actemra, Rasuvo

Top reporter: Novartis Pharmaceuticals Corporation

Corticosteroid [EPC]Interleukin-1 Receptor Antagonist [EPC]Interleukin-6 Receptor Antagonist [EPC]Folate Analog Metabolic Inhibitor [EPC]Tumor Necrosis Factor Blocker [EPC]
10,642
Total Reports
4,207
Serious Reports
466
Death Reports
30
Reported Reactions
Death Report Ratio: Moderate (4.38%)

Patient Demographics

Male
3,991
Female
5,396

Reported Adverse Reactions (30)

Side effects reported in FDA adverse event reports for Canakinumab.

# Reaction Reports % of Total
1 PYREXIA 1,415
8.8%
2 INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION 1,242
7.7%
3 DRUG INEFFECTIVE 1,195
7.4%
4 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION 954
5.9%
5 PAIN 937
5.8%
6 CONDITION AGGRAVATED 853
5.3%
7 MALAISE 721
4.5%
8 OFF LABEL USE 693
4.3%
9 ARTHRALGIA 606
3.7%
10 RASH 561
3.5%
11 INCORRECT DOSE ADMINISTERED 502
3.1%
12 JOINT SWELLING 487
3.0%
13 HEADACHE 438
2.7%
14 FATIGUE 389
2.4%
15 PULMONARY EMBOLISM 387
2.4%
16 DIVERTICULITIS 381
2.4%
17 RENAL FAILURE 375
2.3%
18 DEEP VEIN THROMBOSIS 336
2.1%
19 COUGH 330
2.0%
20 PNEUMONIA 330
2.0%
21 PRODUCT USE IN UNAPPROVED INDICATION 330
2.0%
22 APPARENT DEATH 324
2.0%
23 C-REACTIVE PROTEIN INCREASED 316
2.0%
24 COVID-19 310
1.9%
25 SEPSIS 308
1.9%
26 VOMITING 299
1.8%
27 URTICARIA 298
1.8%
28 DIARRHOEA 293
1.8%
29 ABDOMINAL PAIN 280
1.7%
30 ILLNESS 278
1.7%

Important Disclaimer

FDA adverse event reports are submitted voluntarily and do not prove causation. A reported reaction does not mean the drug caused it. Drugs with more users naturally have more reports. Always consult your doctor or pharmacist before making medication decisions.