CANAKINUMAB

N/A

Manufactured by Novartis Pharmaceuticals Corporation

25,877 FDA adverse event reports analyzed

Last updated: 2026-04-14

About CANAKINUMAB

CANAKINUMAB is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Novartis Pharmaceuticals Corporation. The most commonly reported adverse reactions for CANAKINUMAB include PYREXIA, INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION, DRUG INEFFECTIVE, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION, PAIN. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for CANAKINUMAB.

Top Adverse Reactions

PYREXIA1,405 reports
INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION1,242 reports
DRUG INEFFECTIVE1,189 reports
INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION953 reports
PAIN934 reports
CONDITION AGGRAVATED841 reports
MALAISE714 reports
OFF LABEL USE679 reports
ARTHRALGIA605 reports
RASH558 reports
INCORRECT DOSE ADMINISTERED502 reports
JOINT SWELLING487 reports
HEADACHE432 reports
PULMONARY EMBOLISM387 reports
FATIGUE386 reports
DIVERTICULITIS381 reports
RENAL FAILURE374 reports
DEEP VEIN THROMBOSIS336 reports
PRODUCT USE IN UNAPPROVED INDICATION328 reports
COUGH327 reports
PNEUMONIA326 reports
APPARENT DEATH324 reports
C REACTIVE PROTEIN INCREASED315 reports
COVID 19308 reports
SEPSIS307 reports
URTICARIA296 reports
VOMITING295 reports
DIARRHOEA291 reports
ABDOMINAL PAIN279 reports
ILLNESS274 reports
STILL^S DISEASE262 reports
RED BLOOD CELL SEDIMENTATION RATE INCREASED253 reports
HAEMOPHAGOCYTIC LYMPHOHISTIOCYTOSIS244 reports
NASOPHARYNGITIS242 reports
NAUSEA240 reports
THROMBOSIS230 reports
INTERSTITIAL LUNG DISEASE225 reports
FEELING ABNORMAL224 reports
INFLUENZA220 reports
PULMONARY THROMBOSIS210 reports
INFECTION208 reports
PAIN IN EXTREMITY196 reports
ARTHRITIS182 reports
HERPES ZOSTER177 reports
DYSPNOEA169 reports
MYOCARDIAL INFARCTION166 reports
C REACTIVE PROTEIN ABNORMAL164 reports
DEATH163 reports
HAEMOGLOBIN DECREASED162 reports
PRODUCT DOSE OMISSION ISSUE162 reports
INTENTIONAL PRODUCT USE ISSUE159 reports
DRUG INTOLERANCE157 reports
HYPERTENSION156 reports
INFLAMMATION156 reports
STOMATITIS153 reports
WEIGHT INCREASED153 reports
TERMINAL STATE151 reports
JUVENILE IDIOPATHIC ARTHRITIS149 reports
OROPHARYNGEAL PAIN146 reports
PRURITUS143 reports
DRUG HYPERSENSITIVITY142 reports
ARTHROPATHY140 reports
MYALGIA137 reports
RHINORRHOEA137 reports
DIZZINESS136 reports
ERYTHEMA134 reports
ASTHENIA125 reports
CELLULITIS125 reports
CONTRAINDICATED PRODUCT ADMINISTERED123 reports
CHEST PAIN122 reports
ABDOMINAL PAIN UPPER121 reports
BACK PAIN120 reports
INJECTION SITE PAIN117 reports
PHOTOSENSITIVITY REACTION116 reports
WEIGHT DECREASED115 reports
PRODUCT USE ISSUE110 reports
URINARY TRACT INFECTION109 reports
UPPER RESPIRATORY TRACT INFECTION107 reports
CRYOPYRIN ASSOCIATED PERIODIC SYNDROME105 reports
LYMPHADENOPATHY105 reports
PRODUCT STORAGE ERROR103 reports
DRUG INEFFECTIVE FOR UNAPPROVED INDICATION101 reports
ANAEMIA100 reports
NASAL CONGESTION98 reports
CHILLS95 reports
LUNG DISORDER93 reports
ANXIETY90 reports
VIRAL INFECTION88 reports
OSTEOPOROSIS87 reports
MATERNAL EXPOSURE DURING PREGNANCY83 reports
FALL81 reports
HYPERSENSITIVITY81 reports
THROMBOCYTOPENIA81 reports
GAIT DISTURBANCE80 reports
GROWTH RETARDATION80 reports
INSOMNIA80 reports
DISEASE RECURRENCE79 reports
GASTROINTESTINAL DISORDER79 reports
FAMILIAL MEDITERRANEAN FEVER78 reports
BRONCHITIS77 reports

Report Outcomes

Out of 10,556 classified reports for CANAKINUMAB:

Serious 46.6%Non-Serious 53.4%

The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.

Demographics Breakdown

Reports by Sex

Female5,358 (57.5%)
Male3,954 (42.4%)
Unknown12 (0.1%)

Reports by Age

Age 8205 reports
Age 7179 reports
Age 3177 reports
Age 4170 reports
Age 5168 reports
Age 10163 reports
Age 6158 reports
Age 12157 reports
Age 11136 reports
Age 15132 reports
Age 13126 reports
Age 14123 reports
Age 57123 reports
Age 17122 reports
Age 9121 reports
Age 16120 reports
Age 58120 reports
Age 18114 reports
Age 295 reports
Age 2088 reports

Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.

Frequently Asked Questions

How many FDA adverse event reports are associated with CANAKINUMAB?

This profile reflects 25,877 FDA FAERS reports that mention CANAKINUMAB. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for CANAKINUMAB?

Frequently reported terms in FAERS include PYREXIA, INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION, DRUG INEFFECTIVE, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION, PAIN, CONDITION AGGRAVATED. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures CANAKINUMAB?

Labeling and FAERS entries often list Novartis Pharmaceuticals Corporation in connection with CANAKINUMAB. Always verify the specific product and NDC with your pharmacist.

Important Disclaimer: This content is generated by AI analysis of FDA adverse event reports and is provided for informational purposes only. It is not medical advice. Adverse event reports submitted to the FDA do not prove that a medication caused the reported side effect. Always consult your healthcare provider before starting, stopping, or changing any medication. If you experience a serious side effect, contact your doctor or call 911 immediately.