Drug Safety Information for KINERET (Anakinra)

Safety-related Labeling Changes for KINERET (ANAKINRA) Rx Drug: FDA Link

Adverse Drug Reactions for KINERET* (Anakinra)

These charts and graphs are based on reports received through the FDA Adverse Event Reporting System (FAERS) program (see below).

Top 20 Adverse Effects Associated with KINERET
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Pyrexia115
2Injection site pain106
3Drug ineffective105
4Injection site reaction94
5Injection site erythema77
6Histiocytosis haematophagic77
7Arthralgia71
8Rheumatoid arthritis69
9Rash63
10Condition aggravated56
11Vomiting53
12Dyspnoea52
13Pneumonia47
14Headache45
15Nausea45
16Pruritus42
17Injection site pruritus42
18Pain41
19Fatigue41
20Diarrhoea40

* This side effect also appears in "Top 10 Side Effects of KINERET " in the drug's Review Summary based on AskaPatient reviews.

Top 10 Reasons for Taking KINERET
(associated with FDA Medwatch/FAERS Reports)

Reason # of FDA Reports
1Rheumatoid arthritis1921
2Juvenile arthritis1107
3Product used for unknown indication773
4Still's disease adult onset214
5Chronic infantile neurological cutaneous and articular syndrome132
6Gout67
7Polyarthritis63
8Arthritis49
9Pre-existing disease48
10Amyloidosis45

*Also a top-10 reason in AskaPatient Review Summary.


Types of Adverse Events for KINERET

Total Reports Filed with FDA: 6200


Number of FDA Adverse Event Reports by Patient Age for KINERET

Total Reports Filed with FDA: 6200*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Anakinra (Kineret, Il-1ra)

Charts are based on 6200 reports filed with the FDA between 2004 and June 2015.

Adverse Event Reports are submitted to the FDA by pharmaceutical companies (mandatory reporting is required by manufacturers, distributors, or importers), health care providers such as doctors (voluntary reporting), and by patients themselves (voluntary reporting). More Information on FDA MedWatch (FDA Safety Information and Adverse Event Reporting Program)Voluntary reporting takes place under the FDA's MedWatch program, where health care professionals and consumers submit reports to FDA when they find a problem with a drug, medical device, biologic, or other FDA-regulated product. An adverse event is any undesirable experience or extreme side effect associated with the use of a medical product. Adverse events include: death, life threatening event, hospitalization, disability or permanent damage, congenital anomaly or birth defect, medical product use requiring a surgical or other intervention, or other serious medical situation believed to be caused by the drug.

Click to go back to search results and KINERET Reviews and Review Summary .

Historical Analytics of FDA Adverse Event Reports Provided by Druginformer.com. FDA Drug Safety Information, including safety-related labeling updates, required post-approval safety studies, risk evaluation management strategies (REMS), alerts, and recalls are compiled by AskaPatient.com from the U.S. Food and Drug Administration.