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KINERET

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Kineret Adverse Events Reported to the FDA Over Time

How are Kineret adverse event reports trending over time?

This graph shows volume of adverse events submitted to the FDA by quarter for Kineret, as well as related generic and/or brandname drugs containing the same primary active ingredients. Adverse events are counted if Kineret is flagged as the suspect drug causing the adverse event.

Most Common Kineret Adverse Events Reported to the FDA

What are the most common Kineret adverse events reported to the FDA?

Injection Site Pain
101 (2.56%)
Injection Site Reaction
99 (2.51%)
Pyrexia
85 (2.15%)
Injection Site Erythema
74 (1.87%)
Drug Ineffective
65 (1.65%)
Rash
53 (1.34%)
Rheumatoid Arthritis
51 (1.29%)
Histiocytosis Haematophagic
47 (1.19%)
Condition Aggravated
44 (1.11%)
Injection Site Pruritus
44 (1.11%)
Dyspnoea
43 (1.09%)
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Vomiting
43 (1.09%)
Injection Site Swelling
38 (.96%)
Hypersensitivity
37 (.94%)
Pruritus
36 (.91%)
Arthralgia
32 (.81%)
Nausea
32 (.81%)
Urticaria
32 (.81%)
Diarrhoea
29 (.73%)
Headache
29 (.73%)
Juvenile Arthritis
27 (.68%)
Aspartate Aminotransferase Increase...
25 (.63%)
Erythema
25 (.63%)
Injection Site Rash
25 (.63%)
Oedema Peripheral
24 (.61%)
Alanine Aminotransferase Increased
23 (.58%)
Arthritis
23 (.58%)
Injection Site Haematoma
21 (.53%)
Injection Site Irritation
21 (.53%)
Pain In Extremity
21 (.53%)
Lymphadenopathy
19 (.48%)
Malaise
19 (.48%)
Neutropenia
19 (.48%)
Pain
19 (.48%)
Fatigue
18 (.46%)
Immunosuppression
18 (.46%)
Infection
18 (.46%)
Renal Failure
18 (.46%)
Cardiac Failure
17 (.43%)
Pneumonia
17 (.43%)
Staphylococcal Infection
17 (.43%)
Injection Site Warmth
16 (.41%)
Sepsis
16 (.41%)
Atrial Fibrillation
15 (.38%)
Cough
15 (.38%)
Cytolytic Hepatitis
15 (.38%)
General Physical Health Deteriorati...
15 (.38%)
Haemoglobin Decreased
15 (.38%)
Inflammation
15 (.38%)
Parvovirus Infection
15 (.38%)
Rash Erythematous
15 (.38%)
Rash Generalised
15 (.38%)
Convulsion
14 (.35%)
Death
14 (.35%)
Pleural Effusion
14 (.35%)
Asthenia
13 (.33%)
Cellulitis
13 (.33%)
Dizziness
13 (.33%)
Impaired Healing
13 (.33%)
Herpes Zoster
12 (.3%)
Therapeutic Response Decreased
12 (.3%)
Thrombocytopenia
12 (.3%)
White Blood Cell Count Decreased
12 (.3%)
Angioedema
11 (.28%)
Leukopenia
11 (.28%)
Malignant Melanoma
11 (.28%)
Skin Cancer
11 (.28%)
Abdominal Pain
10 (.25%)
Acute Respiratory Distress Syndrome
10 (.25%)
Anaphylactic Reaction
10 (.25%)
Blister
10 (.25%)
Cerebrovascular Accident
10 (.25%)
Chest Pain
10 (.25%)
Eczema
10 (.25%)
Eosinophilia
10 (.25%)
Hepatic Steatosis
10 (.25%)
Metastases To Lymph Nodes
10 (.25%)
Pancytopenia
10 (.25%)
Red Blood Cell Sedimentation Rate I...
10 (.25%)
Septic Shock
10 (.25%)
Upper Respiratory Tract Infection
10 (.25%)
Viral Infection
10 (.25%)
Acute Hepatic Failure
9 (.23%)
Bronchitis
9 (.23%)
C-reactive Protein Increased
9 (.23%)
Injection Site Urticaria
9 (.23%)
Joint Swelling
9 (.23%)
Myocardial Infarction
9 (.23%)
Rhinorrhoea
9 (.23%)
Urinary Tract Infection
9 (.23%)
Weight Increased
9 (.23%)
Abscess
8 (.2%)
Alopecia
8 (.2%)
Anaemia
8 (.2%)
Antibody Test Positive
8 (.2%)
Arm Amputation
8 (.2%)
Chronic Infantile Neurological Cuta...
8 (.2%)
Contusion
8 (.2%)
Depression
8 (.2%)
Drug Effect Decreased
8 (.2%)
Gangrene
8 (.2%)

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This graph shows the top adverse events submitted to the FDA for Kineret, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Kineret is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.

Adverse Event Categories for Kineret

What are the most common Kineret adverse events reported to the FDA?

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This graph shows the top categories of adverse events submitted to the FDA for Kineret, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Kineret is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.

Common Uses of Kineret According to Those Reporting Adverse Events

Why are people taking Kineret, according to those reporting adverse events to the FDA?

Rheumatoid Arthritis
650
Juvenile Arthritis
300
Drug Use For Unknown Indication
168
Pre-existing Disease
27
Stills Disease Adult Onset
22
Polyarthritis
18
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Chronic Infantile Neurological Cuta...
17
Vasculitis
14
Product Used For Unknown Indication
10
Systemic Lupus Erythematosus
9
Osteoarthritis
7
Drug Level
7
Arthritis
6
Psoriatic Arthropathy
6
Connective Tissue Disorder
5
Immune Reconstitution Syndrome
5
Histiocytosis Haematophagic
4
Schnitzlers Syndrome
4
Diffuse Vasculitis
4
Amyloidosis
4
Muckle-wells Syndrome
3
Gout
3
Ankylosing Spondylitis
2
Osteoporosis
2
Polychondritis
2
Erdheim-chester Disease
2
Ocular Hypertension
2
Autoimmune Disorder
1
Sjogrens Syndrome
1
Interferon Gamma Receptor Deficienc...
1
Reiters Syndrome
1
Blood Immunoglobulin D Increased
1
Pyrexia
1
Dermatomyositis
1
Bone Marrow Disorder
1
Castlemans Disease
1
Cryopyrin Associated Periodic Syndr...
1
Ill-defined Disorder
1
Tumour Necrosis Factor Receptor-ass...
1
Crush Injury
1
Urticaria Thermal
1
Antiinflammatory Therapy
1
Multiple Injuries
1
Amyotrophic Lateral Sclerosis
1
Off Label Use
1
Immune System Disorder
1
Sapho Syndrome
1
Breast Cancer
1
Psoriasis
1
Scleroderma
1
Inflammation
1

Drug Labels

LabelLabelerEffective
KineretSwedish Orphan Biovitrum AB (publ)31-DEC-12

Kineret Case Reports

What Kineret safety concerns are being reported by doctors and researchers in the medical literature?

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About Results

This report contains aggregated drug side effects and adverse events for Kineret. The data has been pulled from the United States Food and Drug Administration's (US FDA) Adverse Event Reporting System (AERS), a database containing more than 4,000,000 adverse event reports.

DrugCite expands your query using the Unified Medical Language System (UMLS) to include generic drugs and primary active ingredients. While the core of DrugCite's advanced drug filtering algorithm is based on the industry standard UMLS, DrugCite's proprietary filtering system also includes dozens of additional steps to reconcile malformed drug names in the FDA's data.

DrugCite only counts a drug if the submitter of the adverse event indicates that the drug is suspected to have caused the adverse event.

Depending on how the data is aggregated, different counts may occur. When someone submits an adverse event to the FDA, the submitter can attribute multiple adverse events to one or more drugs. For example, an individual taking Paxil could submit the adverse events "anxiety" and "suicidal ideation" for the same individual safety report (ISR). This means when DrugCite aggregates by adverse event, two distinct adverse events are counted in the adverse event graph; once for "anxiety" and again for "suicidal ideation". However, when DrugCite aggregates by individual safety reports irrespective of the details of the adverse events contained within the safety report, the report is only counted once.

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