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Remicade Adverse Events Reported to the FDA Over Time

How are Remicade adverse event reports trending over time?

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

Most Common Remicade Adverse Events Reported to the FDA

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

Infusion Related Reaction
8768 (3.66%)
Dyspnoea
4037 (1.69%)
Pyrexia
2898 (1.21%)
Nausea
2521 (1.05%)
Arthralgia
2488 (1.04%)
Vomiting
2411 (1.01%)
Pneumonia
2401 (1%)
Drug Ineffective
2240 (.94%)
Headache
2003 (.84%)
Diarrhoea
1857 (.78%)
Rash
1679 (.7%)
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Malaise
1572 (.66%)
Tuberculosis
1563 (.65%)
Chest Pain
1560 (.65%)
Flushing
1556 (.65%)
Lupus-like Syndrome
1461 (.61%)
Pain
1451 (.61%)
Abdominal Pain
1432 (.6%)
Death
1402 (.59%)
Dizziness
1353 (.56%)
Erythema
1352 (.56%)
Pneumocystis Jiroveci Pneumonia
1328 (.55%)
Chest Discomfort
1323 (.55%)
Fatigue
1315 (.55%)
Pruritus
1267 (.53%)
Urticaria
1236 (.52%)
Chills
1223 (.51%)
Fall
1223 (.51%)
Back Pain
1215 (.51%)
Asthenia
1201 (.5%)
Herpes Zoster
1194 (.5%)
Breast Cancer
1143 (.48%)
Sepsis
1136 (.47%)
Drug Exposure During Pregnancy
1129 (.47%)
Weight Decreased
1121 (.47%)
Paraesthesia
1091 (.46%)
Cough
1057 (.44%)
Hypersensitivity
1029 (.43%)
Pulmonary Tuberculosis
985 (.41%)
Hypoaesthesia
984 (.41%)
Tachycardia
984 (.41%)
Oedema Peripheral
967 (.4%)
Hypotension
954 (.4%)
Hypertension
949 (.4%)
Lymphoma
933 (.39%)
Palpitations
888 (.37%)
Infection
887 (.37%)
Blood Pressure Increased
850 (.35%)
Colitis Ulcerative
846 (.35%)
Psoriasis
841 (.35%)
Tremor
836 (.35%)
Systemic Lupus Erythematosus
821 (.34%)
Pain In Extremity
819 (.34%)
Myalgia
815 (.34%)
Skin Cancer
777 (.32%)
Myocardial Infarction
776 (.32%)
Anaemia
773 (.32%)
Disseminated Tuberculosis
766 (.32%)
Blood Pressure Decreased
747 (.31%)
Hyperhidrosis
722 (.3%)
Rheumatoid Arthritis
699 (.29%)
Dehydration
692 (.29%)
Urinary Tract Infection
688 (.29%)
Surgery
682 (.28%)
Pleural Effusion
679 (.28%)
Arthritis
673 (.28%)
Neoplasm Malignant
663 (.28%)
Interstitial Lung Disease
653 (.27%)
Loss Of Consciousness
652 (.27%)
Liver Disorder
646 (.27%)
Fistula
622 (.26%)
Cerebrovascular Accident
612 (.26%)
Basal Cell Carcinoma
599 (.25%)
Lung Neoplasm Malignant
598 (.25%)
Respiratory Failure
594 (.25%)
Renal Failure
588 (.25%)
Staphylococcal Infection
586 (.24%)
Nephrolithiasis
582 (.24%)
Depression
577 (.24%)
Hospitalisation
559 (.23%)
Joint Swelling
545 (.23%)
Weight Increased
544 (.23%)
Oxygen Saturation Decreased
535 (.22%)
Anxiety
532 (.22%)
Heart Rate Increased
514 (.21%)
Throat Tightness
514 (.21%)
Cellulitis
511 (.21%)
Cytomegalovirus Infection
498 (.21%)
Alopecia
496 (.21%)
Vision Blurred
496 (.21%)
Drug Interaction
492 (.21%)
Atrial Fibrillation
491 (.21%)
Condition Aggravated
484 (.2%)
Abdominal Pain Upper
482 (.2%)
Feeling Abnormal
478 (.2%)
Malignant Melanoma
478 (.2%)
Syncope
477 (.2%)
Therapeutic Response Decreased
477 (.2%)
Sinusitis
476 (.2%)
Anaphylactic Reaction
469 (.2%)
Muscle Spasms
462 (.19%)

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

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

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

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

Rheumatoid Arthritis
22947
Crohns Disease
20242
Colitis Ulcerative
4965
Ankylosing Spondylitis
3538
Drug Use For Unknown Indication
2800
Psoriatic Arthropathy
2700
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Psoriasis
2476
Product Used For Unknown Indication
2096
Inflammatory Bowel Disease
1163
Juvenile Arthritis
334
Behcets Syndrome
308
Arthritis
303
Colitis
302
Drug Exposure During Pregnancy
284
Uveitis
187
Spondyloarthropathy
156
Polyarthritis
142
Spondylitis
141
Sarcoidosis
130
Pyoderma Gangrenosum
126
Pustular Psoriasis
104
Fistula
80
Ill-defined Disorder
70
Foetal Exposure During Pregnancy
65
Hidradenitis
61
Maternal Exposure During Pregnancy
57
Vasculitis
52
Anal Fistula
51
Inflammation
48
Enterocolitis Haemorrhagic
47
Musculoskeletal Pain
45
Graft Versus Host Disease
39
Erythrodermic Psoriasis
36
Irritable Bowel Syndrome
35
Seronegative Arthritis
35
Gastrointestinal Disorder
32
Iritis
31
Takayasus Arteritis
30
Wegeners Granulomatosis
28
Systemic Lupus Erythematosus
24
Transmission Of Drug Via Semen
21
Proctocolitis
20
Temporal Arteritis
20
Polyarteritis Nodosa
19
Kawasakis Disease
19
Drug Dependence
17
Reiters Syndrome
16
Osteoarthritis
16
Dermatomyositis
16
Paternal Drugs Affecting Foetus
16
Polychondritis
15

Drug Labels

LabelLabelerEffective
RemicadeJanssen Biotech, Inc.31-MAR-13

Remicade Case Reports

What Remicade 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 Remicade. 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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