DrugCite
Search

INFLIXIMAB

Adverse Events
Drug Profile
Learn More
Reference
About Results
Comments

Infliximab Adverse Events Reported to the FDA Over Time

How are Infliximab adverse event reports trending over time?

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

Most Common Infliximab Adverse Events Reported to the FDA

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

Infusion Related Reaction
505 (1.7%)
Skin Cancer
503 (1.7%)
Colitis Ulcerative
431 (1.45%)
Neoplasm Malignant
361 (1.22%)
Pneumonia
313 (1.06%)
Pyrexia
313 (1.06%)
Liver Disorder
312 (1.05%)
Drug Ineffective
307 (1.04%)
Dyspnoea
257 (.87%)
Abdominal Pain
230 (.78%)
Vomiting
220 (.74%)
Show More Show More
Tuberculosis
219 (.74%)
Lupus-like Syndrome
214 (.72%)
Breast Cancer
212 (.71%)
Basal Cell Carcinoma
210 (.71%)
Sepsis
205 (.69%)
Pulmonary Tuberculosis
189 (.64%)
Drug Exposure During Pregnancy
185 (.62%)
Nausea
160 (.54%)
Respiratory Failure
160 (.54%)
Condition Aggravated
159 (.54%)
Dehydration
158 (.53%)
Psoriasis
139 (.47%)
Headache
137 (.46%)
Disseminated Tuberculosis
133 (.45%)
Diarrhoea
129 (.43%)
Pleural Effusion
126 (.42%)
Arthralgia
125 (.42%)
Multi-organ Failure
125 (.42%)
Death
122 (.41%)
Myocardial Infarction
119 (.4%)
Anaemia
116 (.39%)
Colon Cancer
116 (.39%)
Squamous Cell Carcinoma
115 (.39%)
Fistula
114 (.38%)
Lung Neoplasm Malignant
114 (.38%)
Rash
112 (.38%)
Herpes Zoster
111 (.37%)
Hypersensitivity
111 (.37%)
Inflammatory Bowel Disease
110 (.37%)
Infection
109 (.37%)
Asthenia
108 (.36%)
Hypotension
104 (.35%)
Pulmonary Embolism
104 (.35%)
Tachycardia
99 (.33%)
Arthritis
97 (.33%)
Malaise
97 (.33%)
Premature Baby
95 (.32%)
Hypertension
93 (.31%)
Weight Decreased
93 (.31%)
Flushing
92 (.31%)
Renal Failure Acute
92 (.31%)
Cytomegalovirus Infection
91 (.31%)
Chest Pain
90 (.3%)
Lymphoma
90 (.3%)
Ileal Stenosis
88 (.3%)
Malignant Melanoma
88 (.3%)
Small Intestinal Obstruction
88 (.3%)
Cellulitis
87 (.29%)
Acute Respiratory Distress Syndrome
86 (.29%)
Cardiovascular Disorder
86 (.29%)
Cough
86 (.29%)
Septic Shock
86 (.29%)
Thrombocytopenia
86 (.29%)
Pneumonia Legionella
85 (.29%)
Systemic Lupus Erythematosus
84 (.28%)
Pneumocystis Jiroveci Pneumonia
82 (.28%)
Renal Failure
82 (.28%)
Staphylococcal Infection
82 (.28%)
Atrial Fibrillation
79 (.27%)
Cerebrovascular Accident
79 (.27%)
Colitis
77 (.26%)
Myalgia
75 (.25%)
Urinary Tract Infection
75 (.25%)
Rheumatoid Arthritis
73 (.25%)
Perirectal Abscess
70 (.24%)
Anaphylactic Reaction
69 (.23%)
Chest Discomfort
69 (.23%)
Gastroenteritis
67 (.23%)
Chills
66 (.22%)
Deep Vein Thrombosis
66 (.22%)
Depression
66 (.22%)
Intestinal Obstruction
66 (.22%)
Oedema Peripheral
66 (.22%)
Cardiac Failure Congestive
65 (.22%)
Haemoglobin Decreased
65 (.22%)
Interstitial Lung Disease
65 (.22%)
Fatigue
64 (.22%)
Loss Of Consciousness
64 (.22%)
Lymphadenopathy
64 (.22%)
Anal Fistula
63 (.21%)
Hyperhidrosis
63 (.21%)
Gastrointestinal Haemorrhage
62 (.21%)
Respiratory Distress
62 (.21%)
Pain
60 (.2%)
Palpitations
59 (.2%)
Premature Labour
59 (.2%)
Abortion Spontaneous
58 (.2%)
Cardiac Failure
58 (.2%)
Coronary Artery Disease
58 (.2%)
Dizziness
58 (.2%)

ExportShare/Embed GraphExport Export Data

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

What are the most common Infliximab 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 Infliximab, 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 Infliximab 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 Infliximab According to Those Reporting Adverse Events

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

Rheumatoid Arthritis
4005
Crohns Disease
2753
Inflammatory Bowel Disease
714
Colitis Ulcerative
669
Psoriasis
638
Drug Use For Unknown Indication
606
Show More Show More
Ankylosing Spondylitis
419
Psoriatic Arthropathy
277
Product Used For Unknown Indication
219
Drug Exposure During Pregnancy
121
Juvenile Arthritis
116
Ill-defined Disorder
106
Graft Versus Host Disease
68
Behcets Syndrome
49
Sarcoidosis
42
Chronic Obstructive Pulmonary Disea...
42
Colitis
37
Kawasakis Disease
37
Uveitis
35
Arthritis
30
Spondyloarthropathy
26
Inflammation
25
Cachexia
25
Maternal Exposure During Pregnancy
23
Wegeners Granulomatosis
22
Hepatitis C
21
Hidradenitis
20
Takayasus Arteritis
19
Spondylitis
19
Pustular Psoriasis
19
Vasculitis
18
Dermatomyositis
16
Anorectal Disorder
16
Polyarthritis
15
Pyoderma Gangrenosum
14
Erythrodermic Psoriasis
14
Idiopathic Pulmonary Fibrosis
14
Myelodysplastic Syndrome
13
Exposure Via Semen
12
Immunosuppression
11
Sciatica
11
Chronic Obstructive Airways Disease
10
Scleritis
8
Transmission Of Drug Via Semen
8
Sweat Gland Infection
7
Systemic Lupus Erythematosus
7
Foetal Exposure During Pregnancy
7
Sle Arthritis
7
Sjogrens Syndrome
7
Polychondritis
6
Chronic Granulomatous Disease
6

Drug Labels

LabelLabelerEffective
RemicadeJanssen Biotech, Inc.31-MAR-13

Infliximab Case Reports

What Infliximab 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 Infliximab. 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 Infliximab.