Infliximab Recombinant adverse event reports that FDA received

Name: Reaction terms in FDA adverse event reports that name Infliximab Recombinant
Creator: Reported Reactions
License: https://creativecommons.org/publicdomain/zero/1.0/

Name type: Product name as reported

What a report is

A report is not proof that the drug was the cause of the event.

FDA says:

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product.
Source: openFDA, Drug Adverse Event Overview, section "Responsible use of the data". The site read the page on 2 Oct 2026. The data have the reports that FDA received through 30 Jun 2026.

FDA also says:

There is no certainty that the reported event (adverse event or medication error) was actually due to the product. FDA does not require that a causal relationship between a product and event be proven, and reports do not always contain enough detail to properly evaluate an event. The information in these reports has not been scientifically or otherwise verified as to a cause and effect relationship and cannot be used to estimate the incidence of these events.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.
Source: openFDA, Response of the drug event API (meta.disclaimer). The site read the page on 2 Oct 2026.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

Drug reports received through 30 Jun 2026. Device reports have a separate cutoff, 30 Sep 2026. Why a report count is not a rate.

Reports on file

From February 2004 to September 2021, FDA received 8,049 adverse event reports that name Infliximab Recombinant. The name is as reporters wrote it. In these reports the drug is a suspect or interacting product.

In the same period, 17 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 0 reports in the 12 months to June 2026 and 0 in the 12 months before. FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

Reports from consumers or other non-health professionals were 5.6% of the reports that name Infliximab Recombinant and 45.8% of all drug reports.

The number of people who use the product is not in the data. A count is not a rate. A count of reports is not a count of events or of patients, because one event can have more than one report.

There are many instances of duplicative reports and some reports do not contain all the necessary information.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

Suspect product

FDA records each drug in a report as suspect, concomitant or interacting. This page counts the reports in which Infliximab Recombinant is suspect or interacting. FDA says:

Any number of the drugs may be marked as suspect if thought to be responsible for one or more of the reactions, but that information is not validated.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Data version

openFDA FAERS release of 29 Oct 2026. Reports received through 30 Jun 2026.

Since the last update

FDA says:

Many factors can influence whether or not an event will be reported, such as the time a product has been marketed and publicity about an event.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The information in these reports cannot be used to estimate the incidence (occurrence rates) of the events reported.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

The latest update of the FDA data, recorded on 28 Oct 2026, changed no count of this page.

FDA received no report that names Infliximab Recombinant in April to June 2026, in January to March 2026 or in April to June 2025.

April to June 2026 is the latest closed quarter in the data. A closed quarter is a quarter for which the FDA files have most of the reports.

All updates Feed of updates (RSS)

Reaction lookup

These are the reaction terms that the reports record, with the number of reports for each term. Type a term or a plain word to find its count.

What this list leaves out

The table lists the 576 reaction terms that 5 or more reports record. A term with fewer than 5 reports is not in the table.

The site keeps reaction terms for 8,038 of the 8,049 reports (99.9%).

The reports of the other years are not in the counts.

So a count in the table can be lower than the count of FDA.

Find a reaction term

The table shows the first 50 of 576 terms.

Reaction terms in the reports that name Infliximab Recombinant, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 8,049 reports
Off label useused for a purpose or in a way not on the label	1,553	19.3%
Drug ineffectivethe medicine did not work as expected	589	7.3%
Product use issuea problem in how the product was used	583	7.2%
Condition aggravatedthe condition being treated got worse	565	7%
Intentional product use issuedeliberate use not as intended	489	6.1%
Infusion related reactiona reaction during or soon after an infusion	431	5.4%
Inappropriate schedule of product administrationthe product was taken at the wrong times	360	4.5%
Crohn's disease	354	4.4%
Blood pressure fluctuation	282	3.5%
Arthralgiajoint pain	276	3.4%
Tuberculosis	266	3.3%
Infectionan infection, type not specified	235	2.9%
Pneumonialung infection	218	2.7%
Lupus-like syndromelupus-like symptoms	210	2.6%
Nauseafeeling sick	209	2.6%
Weight increasedweight gain	208	2.6%
Colitis ulcerative	201	2.5%
Dyspnoeashortness of breath	189	2.3%
Headachehead pain	188	2.3%
Pyrexiafever	188	2.3%
Pulmonary tuberculosis	186	2.3%
Blood pressure increaseda raised blood pressure reading	181	2.2%
Product use in unapproved indicationused for a purpose not on the label	180	2.2%
Fatiguetiredness	179	2.2%
Malaisegeneral feeling of being unwell	176	2.2%
Weight decreasedweight loss	168	2.1%
Psoriasispsoriasis, a skin condition	164	2%
Abdominal painstomach or belly pain	154	1.9%
Hypersensitivityan allergic-type reaction	148	1.8%
Therapeutic response decreasedthe medicine worked less well	145	1.8%
Rashskin rash	139	1.7%
Painpain, site not specified	125	1.6%
Pruritusitching	121	1.5%
Crohn's diseaseCrohn's disease, an inflammatory bowel disease	120	1.5%
Diarrhoealoose or frequent stools	120	1.5%
Vomitingbeing sick	117	1.5%
Nasopharyngitisa cold	116	1.4%
Adverse eventan unwanted medical event, type not specified	115	1.4%
Disseminated tuberculosis	113	1.4%
Drug specific antibody present	113	1.4%
Herpes zostershingles	111	1.4%
Cough	109	1.4%
Heart rate decreased	106	1.3%
Hypertensionhigh blood pressure	103	1.3%
Dizzinesslight-headedness or unsteadiness	102	1.3%
Incorrect dose administeredthe wrong dose was given	101	1.3%
Exposure during pregnancythe medicine was taken during pregnancy	100	1.2%
Urinary tract infectionbladder or urinary infection	99	1.2%
Neoplasm malignanta cancer, type not specified	93	1.2%
Heart rate irregular	92	1.1%

Download all 576 terms of Infliximab Recombinant (CSV)

The counts add to more than 8,049 reports, because one report can record more than one term. FDA says:

No individual drug is connected to any individual reaction. When a report lists multiple drugs and multiple reactions, there is no way to conclude from the data therein that a given drug is responsible for a given reaction.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The CSV file has the same rows and the same limits. Its last row is a note that says so.

MedDRA term

The person who codes a report selects the preferred term that agrees best with the description of the reporter. The words under a term are the plain meaning that this site gives.

Not the label

The FDA-approved label of a product lists its adverse reactions. See the official pages at the end of this page.

Outcomes by year

The table gives the outcomes that the reporters gave, in the terms of FDA.

Outcomes in the reports that name Infliximab Recombinant, by the year of the openFDA file that holds the report

The table continues to the right.

Year of the openFDA file	Reports	Serious	Death	Life-threatening	Hospitalization (initial or prolonged)	Disability or Permanent Damage	Congenital Anomaly/Birth Defect	Other Serious (Important Medical Events)	Not serious
2004	4	4	1	2	4	0	0	1	0
2005	13	13	2	1	11	0	0	3	0
2006	7	7	2	2	5	0	0	1	0
2007	19	19	4	2	12	0	0	10	0
2008	26	26	4	3	20	0	0	5	0
2009	17	17	3	2	12	0	0	5	0
2010	270	270	40	17	95	0	1	157	0
2011	671	669	57	21	258	5	6	399	2
2012	664	644	60	16	235	8	0	425	20
2013	605	600	55	11	136	3	23	442	5
2014	480	475	36	7	134	5	1	340	5
2015	914	631	22	21	147	8	2	509	283
2016	528	516	31	13	138	6	5	412	12
2017	383	375	17	13	76	4	5	311	8
2018	530	514	32	27	133	13	1	404	16
2019	564	552	27	30	244	6	4	333	12
2020	1,299	1,291	31	18	531	19	7	867	8
2021	1,055	1,053	21	7	322	9	1	795	2

An outcome in a report is not proof that the drug was the cause. The reporter gives the outcome, and FDA does not verify it. FDA says:

The information in these reports has not been scientifically or otherwise verified as to a cause and effect relationship and cannot be used to estimate the incidence of these events.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The six headings with the names of FDA are the outcome terms of FDA. A report can have more than one outcome. The columns Serious and Not serious are the two values of the openFDA field serious. For the value serious, openFDA gives this description:

The adverse event resulted in death, a life threatening condition, hospitalization, disability, congenital anomaly, or other serious condition
Source: openFDA, Drug adverse event fields (YAML reference). The site read the page on 2 Oct 2026.

The year is the year of the openFDA file that holds the latest version of the report. It is not always the year in which FDA first received the report. The chart of the next section uses the year of first receipt. The latest year is not complete.

Reports by year and month

Reports that name Infliximab Recombinant, by the year in which FDA received them

Show the figures of the chart as a table

Reports that name Infliximab Recombinant, by the year in which FDA received them
Year	Reports
2004	7
2005	13
2006	7
2007	19
2008	26
2009	21
2010	280
2011	724
2012	735
2013	617
2014	471
2015	914
2016	511
2017	360
2018	560
2019	582
2020	1,262
2021	939

Reports that name Infliximab Recombinant, by month, five years to June 2026

FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

Why a count moves

A count moves for many reasons. The guide gives FDA's words about them.

Patients and reporters

Age of the patient in the reports that name Infliximab Recombinant
Age	Reports	Share
Under 2	33	0.4%
2 to 11	147	1.8%
12 to 17	547	6.8%
18 to 44	2,079	25.8%
45 to 64	1,507	18.7%
65 to 74	548	6.8%
75 and over	246	3.1%
Age not given	2,942	36.6%

Sex of the patient in the reports that name Infliximab Recombinant
Sex	Reports	Share
Female	3,358	41.7%
Male	2,793	34.7%
Unknown or not given	1,898	23.6%

Type of reporter in the reports that name Infliximab Recombinant
Reporter	Reports	Share
Physician	3,384	42%
Pharmacist	77	1%
Other health professional	4,123	51.2%
Lawyer	0	0%
Consumer or non-health professional	454	5.6%
Not given	11	0.1%

Age and sex are as the report gives them. The reporter is the primary source in the report. 27.4% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Infliximab Recombinant record
Indication as recorded (MedDRA)	Reports	Share
Crohn's disease	1,958	24.3%
Colitis ulcerative	1,109	13.8%
Rheumatoid arthritis	972	12.1%
Inflammatory bowel disease	891	11.1%
Crohn's disease	360	4.5%
Psoriasis	342	4.2%

The reporter fills in the indication, and the field is often empty. Each share is of all 8,049 reports.

Drugs in the same reports

Other drugs that the reports of Infliximab Recombinant name, in any role, in order of name
Drug	Reports that name the two
Acetaminophen	294
Adalimumab	330
Azathioprine	851
Diphenhydramine	154
Folic acid	308
Humira	331
Hydrocortisone	290
Methotrexate	1,265
Prednisolone	202
Prednisone	905

The table has the 10 drug names that these reports name most. Two names in one report says only that the report recorded the two. It says nothing about the part of a product in the event.

FDA says:

Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Importantly, the AEMS data by themselves are not an indicator of the safety profile of the drug or biologic.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

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These links are for navigation. No count selected them.

Official pages

DailyMed labels for Infliximab RecombinantThe labels (prescribing information) that have this name, at the National Library of Medicine.
MedWatch Online Voluntary Reporting FormThe online form of FDA for a voluntary report.
MedWatch: The FDA Safety Information and Adverse Event Reporting ProgramThe page of the FDA program that receives reports about drugs and devices.
FDA Adverse Event Monitoring System (AEMS) Public DashboardThe public dashboard of FDA for adverse event reports on drugs and biologics.

The site checked these addresses on 2 Oct 2026. The links open in a new tab.

Cite this page

Reported Reactions. Infliximab Recombinant: adverse event reports that FDA received. https://reportedreactions.com/drug/infliximab-recombinant/ Source: U.S. Food and Drug Administration, openFDA Drug Adverse Event (FAERS) files, release of 29 Oct 2026. Reports received through 30 Jun 2026.

Where the data come from

The counts come from the openFDA Drug Adverse Event (FAERS) bulk files, release of 29 Oct 2026. The files have the reports that FDA received through 30 Jun 2026. A drug name is the name on the report. The site matches it to a brand name or a generic name of the National Drug Code Directory of 2 Nov 2026. A class is the pharmacologic class (EPC) of the FDA label.

A report is in the count when it names Infliximab Recombinant as a suspect or interacting product. The 17 reports that name it only as a concomitant medicine are not in the count. The site does not publish a report narrative, a lot number, a detail of a patient or the identity of a reporter. The record of FDA is the authority. See how the site counts reports, the data sources and the corrections page.

Questions

Do these reports show that Infliximab Recombinant was responsible for the reactions?

No. FDA says:

For any given report, there is no certainty that a suspected drug caused the event.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

A reaction can relate to the condition that the drug treats, to other medicines, or to something else.

Is this the list of reactions on the label of Infliximab Recombinant?

No. It is a count of what people reported to FDA: 8,049 reports from February 2004 to September 2021. The FDA-approved label of a product lists its adverse reactions. The official pages at the end of this page link to the labels.

Who sent these reports?

Other health professional (51.2%), physician (42%) and consumer or non-health professional (5.6%). These are the types of reporter for the reports that name this drug.

If a manufacturer receives an adverse event report, it is normally required to send the report to FDA.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

How does a person report an adverse event?

FDA runs MedWatch, a program that takes voluntary reports from health professionals, patients and consumers. The guide on how to report has the links.

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