Drug Safety Information for REMICADE (Infliximab)

Safety-related Labeling Changes for REMICADE (INFLIXIMAB) Rx Drug: FDA Link

Safety-related Labeling Changes for RENFLEXIS (INFLIXIMAB-ABDA) Biological Drug: FDA Link

Safety-related Labeling Changes for IXIFI (INFLIXIMAB-QBTX) Biological Drug: FDA Link

Required post-approval safety study:

Enhanced pharmacovigilance program for reports of malignancy in pediatric, adolescent, and young adult (less than or equal to 30 years of age) patients treated with Remicade (infliximab), for a period of up to 10 years to collect data that will be analyzed to better define the risk of this serious adverse event. The enhanced pharmacovigilance program includes the following: 1) active query of reporters to obtain additional clinical information related to malignancy diagnoses 2) expedited reporting to FDA of all initial and follow-up reports of any malignancy in pediatric, adolescent, and young adult patients. Due Date: 2020-03-31

Required post-approval safety study:

Expand the Pediatric IBD Registry (DEVELOP) to include pediatric patients with ulcerative colitis (UC) and indeterminate colitis (IC). Due Date: 2045-12-31

Required post-approval safety study:

A study to analyze samples from the Pediatric IBD registry (DEVELOP) and PMR 3 to determine the presence of ADA using the new assay developed in PMC 5. Due Date: 2045-12-31

Required post-approval safety study:

Centocor commits to designing and implementing a registry of patients with pediatric Crohn's disease being treated with REMICADE that will be established to obtain long-term clinical status and safety information. Information will be collected on patient demographics, disease characteristics, history of concomitant medications, dose and duration and frequency of REMICADE administration, clinical status, adverse events including dysplasias and malignancies of all types, infections, autoimmune disease, assessment of immunogenicity, and potential effects of antibody formation. The age range should include patients ages 0 to 19 years. This registry will be designed so that detailed clinical status information is collected at registry entry and on a 6 month basis for at least 20 years. Centocor commits to expand the currently existing Pediatric IBD Registry, and will actively encourage both patients and physicians to participate in the registry through an advertisement campaign, that includes a plan for proactive communication of associated risk. Centocor also commits to recruiting at least 2,000 REMICADE treated pediatric Crohn's patients, which will provide an adequate number of patients to participate in the registry so that outcome measures will be collected and adequate risk assessment can be made. Centocor commits to provide prompt risk communication for serious adverse events that are reported through the registry. The registry data will be analyzed at yearly intervals and the results will be submitted in annual reports for BB-IND 5389. Due Date: 2027-06-30

Original FDA Drug Approval Date for REMICADE: 1998-08-24

Adverse Drug Reactions for REMICADE* (Infliximab)

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 REMICADE
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Infusion related reaction6810
2Drug ineffective3484
3Dyspnoea3449
4Crohn's disease2777
5Arthralgia*2442
6Pyrexia2276
7Nausea2254
8Vomiting2006
9Pneumonia1809
10Headache*1783
11Diarrhoea1700
12Rash*1690
13Pain*1683
14Malaise1574
15Abdominal pain1409
16Fatigue*1409
17Weight decreased1345
18Chest pain1341
19Lupus-like syndrome1339
20Flushing1264

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

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

Reason # of FDA Reports
1Crohn's disease*67199
2Rheumatoid arthritis*63106
3Colitis ulcerative*20485
4Product used for unknown indication18241
5Ankylosing spondylitis*11078
6Psoriatic arthropathy*10375
7Psoriasis*6567
8Inflammatory bowel disease2526
9Juvenile arthritis1243
10Arthritis*1101

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


Types of Adverse Events for REMICADE

Total Reports Filed with FDA: 227977


Number of FDA Adverse Event Reports by Patient Age for REMICADE

Total Reports Filed with FDA: 227977*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Infliximab (Remicade)

Charts are based on 227977 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 REMICADE 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.