DrugCite
Search

SIMPONI

Adverse Events
Drug Profile
Learn More
Reference
About Results
Comments

Simponi Adverse Events Reported to the FDA Over Time

How are Simponi adverse event reports trending over time?

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

Most Common Simponi Adverse Events Reported to the FDA

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

Pneumonia
240 (3.01%)
Drug Dose Omission
172 (2.15%)
Device Malfunction
143 (1.79%)
Headache
103 (1.29%)
Drug Ineffective
102 (1.28%)
Hypertension
90 (1.13%)
Dyspnoea
84 (1.05%)
Infection
84 (1.05%)
Pyrexia
84 (1.05%)
Nausea
79 (.99%)
Fatigue
76 (.95%)
Show More Show More
Pain
72 (.9%)
Inappropriate Schedule Of Drug Admi...
69 (.86%)
Arthralgia
68 (.85%)
Pain In Extremity
65 (.81%)
Diarrhoea
64 (.8%)
Dizziness
64 (.8%)
Malaise
64 (.8%)
Rheumatoid Arthritis
62 (.78%)
Vomiting
61 (.76%)
Fall
59 (.74%)
Bronchitis
56 (.7%)
Psoriasis
53 (.66%)
Device Failure
52 (.65%)
Oedema Peripheral
52 (.65%)
Asthenia
51 (.64%)
Herpes Zoster
51 (.64%)
Urinary Tract Infection
47 (.59%)
Paraesthesia
45 (.56%)
Weight Decreased
41 (.51%)
Cough
40 (.5%)
Immediate Post-injection Reaction
40 (.5%)
Sinusitis
40 (.5%)
Chest Pain
39 (.49%)
Depression
37 (.46%)
Staphylococcal Infection
37 (.46%)
Nasopharyngitis
36 (.45%)
Oropharyngeal Pain
36 (.45%)
Rash
36 (.45%)
Arthritis
35 (.44%)
Influenza
35 (.44%)
Cellulitis
34 (.43%)
Decreased Appetite
34 (.43%)
Asthma
32 (.4%)
Breast Cancer
31 (.39%)
Sepsis
31 (.39%)
Tuberculosis
31 (.39%)
Anxiety
29 (.36%)
Chest Discomfort
29 (.36%)
Interstitial Lung Disease
29 (.36%)
Liver Function Test Abnormal
29 (.36%)
Migraine
29 (.36%)
Skin Cancer
29 (.36%)
Therapeutic Response Decreased
29 (.36%)
Abnormal Loss Of Weight
28 (.35%)
Myocardial Infarction
28 (.35%)
Abdominal Pain
27 (.34%)
Death
27 (.34%)
Drug Effect Decreased
27 (.34%)
Neoplasm Malignant
27 (.34%)
Palpitations
27 (.34%)
Blood Cholesterol Increased
26 (.33%)
Diverticulitis
26 (.33%)
Pruritus
26 (.33%)
Skin Ulcer
26 (.33%)
Cerebrovascular Accident
25 (.31%)
Hypoaesthesia
25 (.31%)
Joint Swelling
25 (.31%)
Malignant Melanoma
25 (.31%)
Off Label Use
25 (.31%)
Back Pain
24 (.3%)
Immune System Disorder
24 (.3%)
C-reactive Protein Increased
23 (.29%)
Gastroenteritis
23 (.29%)
Hyperhidrosis
23 (.29%)
Hypotension
22 (.28%)
Knee Arthroplasty
22 (.28%)
Anaemia
21 (.26%)
Cardiac Failure
21 (.26%)
Feeling Abnormal
21 (.26%)
Hypersensitivity
21 (.26%)
Weight Increased
21 (.26%)
Convulsion
20 (.25%)
Lower Respiratory Tract Infection
20 (.25%)
Urticaria
20 (.25%)
Injection Site Haematoma
19 (.24%)
Night Sweats
19 (.24%)
Renal Failure
19 (.24%)
Swelling
19 (.24%)
Upper Respiratory Tract Infection
19 (.24%)
Atrial Fibrillation
18 (.23%)
Colitis
18 (.23%)
Gait Disturbance
18 (.23%)
Hepatic Enzyme Increased
18 (.23%)
Influenza Like Illness
18 (.23%)
Nervousness
18 (.23%)
Rash Generalised
18 (.23%)
Syncope
18 (.23%)
Tachycardia
18 (.23%)
Tremor
18 (.23%)
Abscess
17 (.21%)

ExportShare/Embed GraphExport Export Data

This graph shows the top adverse events submitted to the FDA for Simponi, 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 Simponi 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 Simponi

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

Show More Show More

ExportShare/Embed Graph Export Export Data

This graph shows the top categories of adverse events submitted to the FDA for Simponi, 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 Simponi 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 Simponi According to Those Reporting Adverse Events

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

Rheumatoid Arthritis
1337
Product Used For Unknown Indication
330
Psoriatic Arthropathy
320
Ankylosing Spondylitis
302
Drug Use For Unknown Indication
36
Psoriasis
31
Show More Show More
Ill-defined Disorder
25
Arthritis
19
Crohns Disease
17
Spondylitis
15
Colitis Ulcerative
8
Seronegative Arthritis
8
Juvenile Arthritis
7
Osteoarthritis
5
Musculoskeletal Pain
4
Inflammation
3
Maternal Exposure During Pregnancy
3
Spondyloarthropathy
2
Immune System Disorder
2
Accidental Exposure
2
Autoimmune Disorder
2
Tumour Necrosis Factor Receptor-ass...
1
Neuropathy Peripheral
1
Behcets Syndrome
1
Uveitis
1
Epstein-barr Virus Infection
1
Multiple Sclerosis
1
Unevaluable Event
1
Chest Pain
1
Drug Exposure During Pregnancy
1
Sarcoidosis
1
Proctocolitis
1
Reiters Syndrome
1
Prostatic Specific Antigen
1
Temporal Arteritis
1
Arthritis Reactive
1

Drug Labels

LabelLabelerEffective
SimponiJanssen Biotech, Inc.28-NOV-12

Simponi Case Reports

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

Powered by Google

About Results

This report contains aggregated drug side effects and adverse events for Simponi. 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.

Comments

Share your experience with Simponi.