ANAKINRA

N/A

Manufactured by Swedish Orphan Biovitrum AB (publ)

60,861 FDA adverse event reports analyzed

Last updated: 2026-04-14

About ANAKINRA

ANAKINRA is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Swedish Orphan Biovitrum AB (publ). The most commonly reported adverse reactions for ANAKINRA include OFF LABEL USE, DRUG INEFFECTIVE, CONDITION AGGRAVATED, PAIN, RHEUMATOID ARTHRITIS. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for ANAKINRA.

Top Adverse Reactions

OFF LABEL USE4,976 reports
DRUG INEFFECTIVE4,135 reports
CONDITION AGGRAVATED1,616 reports
PAIN1,558 reports
RHEUMATOID ARTHRITIS1,537 reports
JOINT SWELLING1,181 reports
ARTHRALGIA1,173 reports
DRUG INTOLERANCE1,158 reports
PYREXIA1,122 reports
INJECTION SITE PAIN997 reports
RASH949 reports
NAUSEA934 reports
PRODUCT DOSE OMISSION ISSUE890 reports
INFECTION881 reports
DRUG HYPERSENSITIVITY857 reports
VOMITING854 reports
DIARRHOEA853 reports
CONTRAINDICATED PRODUCT ADMINISTERED836 reports
SYNOVITIS796 reports
FATIGUE741 reports
ARTHROPATHY722 reports
INJECTION SITE ERYTHEMA704 reports
ARTHRITIS682 reports
MALAISE666 reports
THERAPEUTIC PRODUCT EFFECT DECREASED663 reports
MOBILITY DECREASED657 reports
TREATMENT FAILURE647 reports
C REACTIVE PROTEIN INCREASED638 reports
RED BLOOD CELL SEDIMENTATION RATE INCREASED633 reports
SEPTIC SHOCK579 reports
COVID 19578 reports
LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES554 reports
HAEMOPHAGOCYTIC LYMPHOHISTIOCYTOSIS543 reports
LOSS OF CONSCIOUSNESS540 reports
INJECTION SITE REACTION532 reports
INJECTION SITE PRURITUS527 reports
PSORIASIS525 reports
HERPES ZOSTER523 reports
HEADACHE521 reports
ADRENAL INSUFFICIENCY511 reports
DIZZINESS497 reports
PRODUCT USE IN UNAPPROVED INDICATION489 reports
POLYARTHRITIS478 reports
OBESITY466 reports
ILL DEFINED DISORDER461 reports
SWELLING456 reports
INTENTIONAL PRODUCT USE ISSUE455 reports
URTICARIA453 reports
SEPSIS452 reports
PRODUCT USE ISSUE451 reports
HYPERSENSITIVITY449 reports
RENAL FAILURE449 reports
PULMONARY EMBOLISM431 reports
PNEUMONIA430 reports
THERAPEUTIC PRODUCT EFFECT INCOMPLETE428 reports
RED BLOOD CELL SEDIMENTATION RATE ABNORMAL417 reports
DIVERTICULITIS412 reports
PRURITUS412 reports
THERAPY NON RESPONDER408 reports
PERIPHERAL SWELLING396 reports
C REACTIVE PROTEIN ABNORMAL388 reports
BONE DENSITY DECREASED385 reports
HYPERTENSION384 reports
RHEUMATOID FACTOR POSITIVE380 reports
DYSPNOEA372 reports
DEEP VEIN THROMBOSIS369 reports
JUVENILE IDIOPATHIC ARTHRITIS366 reports
INJECTION SITE SWELLING337 reports
DRUG INEFFECTIVE FOR UNAPPROVED INDICATION335 reports
DEATH330 reports
INJECTION SITE URTICARIA328 reports
INJECTION SITE RASH325 reports
APPARENT DEATH322 reports
HYPOTENSION322 reports
ABDOMINAL PAIN319 reports
INJECTION SITE BRUISING312 reports
BODY HEIGHT BELOW NORMAL311 reports
WEIGHT INCREASED310 reports
INTERSTITIAL LUNG DISEASE306 reports
HUMAN ANTICHIMERIC ANTIBODY POSITIVE302 reports
NASOPHARYNGITIS295 reports
PAIN IN EXTREMITY292 reports
INSOMNIA275 reports
INTENTIONAL PRODUCT MISUSE275 reports
ANAEMIA274 reports
STILL^S DISEASE274 reports
LIVER FUNCTION TEST ABNORMAL271 reports
ABDOMINAL DISCOMFORT270 reports
PLEURAL EFFUSION270 reports
MUSCULOSKELETAL STIFFNESS263 reports
THROMBOSIS253 reports
FIBROMYALGIA252 reports
URINARY TRACT INFECTION247 reports
JOINT DESTRUCTION241 reports
FEELING ABNORMAL240 reports
IMMUNODEFICIENCY240 reports
HYPOKALAEMIA239 reports
ALOPECIA236 reports
BACK PAIN236 reports
CONTUSION236 reports

Report Outcomes

Out of 15,855 classified reports for ANAKINRA:

Serious 69.1%Non-Serious 30.9%

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

Female9,606 (65.8%)
Male4,989 (34.2%)
Unknown10 (0.1%)

Reports by Age

Age 60374 reports
Age 58275 reports
Age 40240 reports
Age 56225 reports
Age 3221 reports
Age 63213 reports
Age 6194 reports
Age 12182 reports
Age 57170 reports
Age 50162 reports
Age 2161 reports
Age 59159 reports
Age 74159 reports
Age 62150 reports
Age 68150 reports
Age 7149 reports
Age 49146 reports
Age 61146 reports
Age 17144 reports
Age 65142 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 ANAKINRA?

This profile reflects 60,861 FDA FAERS reports that mention ANAKINRA. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for ANAKINRA?

Frequently reported terms in FAERS include OFF LABEL USE, DRUG INEFFECTIVE, CONDITION AGGRAVATED, PAIN, RHEUMATOID ARTHRITIS, JOINT SWELLING. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures ANAKINRA?

Labeling and FAERS entries often list Swedish Orphan Biovitrum AB (publ) in connection with ANAKINRA. 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.