Rheumatrex adverse event reports that FDA received

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

Name type: Product name as reported
Also reported as: Rheumatrex /00113801/, Rheumatrex /00113802/

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 January 2004 to June 2026, FDA received 4,266 adverse event reports that name Rheumatrex. The name is as reporters wrote it. In these reports the drug is a suspect or interacting product.

In the same period, 1,961 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 27 reports in the 12 months to June 2026 and 77 in the 12 months before. FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

Of the 1,332,454 drug reports that FDA received in the 12 months to June 2026, 27 (under 0.1%) name Rheumatrex. Reports from physicians were 56% of the reports that name Rheumatrex and 21.9% 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 Rheumatrex 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.

In April to June 2026, FDA received 3 reports that name Rheumatrex.
In January to March 2026, FDA received 7.
In April to June 2025, FDA received 20.

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 274 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 4,244 of the 4,266 reports (99.5%).

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 274 terms.

Reaction terms in the reports that name Rheumatrex, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 4,266 reports
Interstitial lung diseasescarring or inflammation of lung tissue	314	7.4%
Pneumonialung infection	263	6.2%
Drug ineffectivethe medicine did not work as expected	198	4.6%
Pancytopenialow counts of all blood cells	186	4.4%
Pneumocystis jiroveci pneumonia	170	4%
Pyrexiafever	156	3.7%
Lymphoproliferative disorder	126	3%
Rheumatoid arthritisrheumatoid arthritis, an inflammatory joint disease	123	2.9%
Pneumocystis jirovecii pneumonia	100	2.3%
Malaisegeneral feeling of being unwell	93	2.2%
Condition aggravatedthe condition being treated got worse	92	2.2%
Herpes zostershingles	92	2.2%
Lymphomaa cancer of the lymphatic system	91	2.1%
Disseminated intravascular coagulation	87	2%
White blood cell count decreasedlow white cell count	86	2%
Sepsisa severe body-wide response to infection	84	2%
Nauseafeeling sick	82	1.9%
Hepatic function abnormal	81	1.9%
Stomatitissore mouth	81	1.9%
Platelet count decreasedlow platelet count	80	1.9%
Renal impairmentreduced kidney function	80	1.9%
Liver disorder	76	1.8%
Arthralgiajoint pain	75	1.8%
Breast cancer	71	1.7%
Pleural effusionfluid around the lung	71	1.7%
Colon cancer	70	1.6%
Anaemialow red blood cells	67	1.6%
Lung neoplasm malignantlung cancer	66	1.5%
Off label useused for a purpose or in a way not on the label	62	1.5%
Diffuse large B-cell lymphoma	61	1.4%
Neoplasm malignanta cancer, type not specified	61	1.4%
Bone marrow failure	60	1.4%
Respiratory failurethe lungs could not supply enough oxygen	58	1.4%
Drug interactionan interaction between medicines	57	1.3%
Diarrhoealoose or frequent stools	54	1.3%
Gastric cancer	53	1.2%
C-reactive protein increased	50	1.2%
Nasopharyngitisa cold	49	1.1%
Pulmonary tuberculosis	49	1.1%
Vomitingbeing sick	48	1.1%
Cough	45	1.1%
Pneumonia bacterial	45	1.1%
Decreased appetitereduced appetite	42	1%
Bone marrow depression	41	1%
Septic shockshock arising from infection	41	1%
Abdominal discomfortstomach discomfort	40	0.9%
Dyspnoeashortness of breath	40	0.9%
Painpain, site not specified	40	0.9%
Cardiac failureheart failure	37	0.9%
Multi-organ failure	37	0.9%

Download all 274 terms of Rheumatrex (CSV)

The counts add to more than 4,266 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 Rheumatrex, 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	Other Serious (Important Medical Events)	Not serious
2004	259	259	70	35	225	2	16	0
2005	76	76	14	10	65	0	16	0
2006	83	83	9	16	68	0	26	0
2007	122	120	22	19	94	1	31	2
2008	126	124	19	17	100	3	36	2
2009	110	110	24	19	88	4	27	0
2010	150	149	31	23	111	2	51	1
2011	130	130	24	14	96	4	52	0
2012	204	201	34	25	133	3	104	3
2013	160	156	10	21	96	6	94	4
2014	140	131	17	25	91	1	75	9
2015	200	186	25	28	107	7	120	14
2016	453	336	31	35	157	2	235	117
2017	392	383	45	29	166	7	277	9
2018	312	284	27	16	124	3	214	28
2019	291	245	29	40	111	8	171	46
2020	427	211	33	22	101	2	155	216
2021	241	219	23	14	84	7	166	22
2022	134	132	9	12	47	2	104	2
2023	97	96	6	5	33	1	78	1
2024	90	90	4	8	34	4	70	0
2025	56	56	4	4	24	2	44	0
2026	13	13	1	3	7	1	11	0

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 Rheumatrex, by the year in which FDA received them

The column of 2026 has an outline, because the year is not complete. It has the reports that FDA received through June 2026 only.

Show the figures of the chart as a table

Reports that name Rheumatrex, by the year in which FDA received them
Year	Reports
2004	253
2005	75
2006	88
2007	125
2008	131
2009	108
2010	151
2011	151
2012	242
2013	162
2014	153
2015	179
2016	473
2017	396
2018	300
2019	282
2020	400
2021	229
2022	132
2023	92
2024	81
2025	53
2026	10

Reports that name Rheumatrex, 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 Rheumatrex
Age	Reports	Share
Under 2	2	under 0.1%
2 to 11	8	0.2%
12 to 17	8	0.2%
18 to 44	157	3.7%
45 to 64	713	16.7%
65 to 74	804	18.8%
75 and over	727	17%
Age not given	1,847	43.3%

Sex of the patient in the reports that name Rheumatrex
Sex	Reports	Share
Female	2,580	60.5%
Male	903	21.2%
Unknown or not given	783	18.4%

Type of reporter in the reports that name Rheumatrex
Reporter	Reports	Share
Physician	2,391	56%
Pharmacist	798	18.7%
Other health professional	305	7.1%
Lawyer	1	under 0.1%
Consumer or non-health professional	612	14.3%
Not given	159	3.7%

Age and sex are as the report gives them. The reporter is the primary source in the report. 13.5% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Rheumatrex record
Indication as recorded (MedDRA)	Reports	Share
Rheumatoid arthritis	2,484	58.2%
Psoriatic arthropathy	48	1.1%
Rheumatic disorder	25	0.6%
Psoriasis	20	0.5%
Arthritis	13	0.3%
Musculoskeletal pain	8	0.2%

The reporter fills in the indication, and the field is often empty. Each share is of all 4,266 reports.

Drugs in the same reports

Other drugs that the reports of Rheumatrex name, in any role, in order of name
Drug	Reports that name the two
Diclofenac sodium	254
Enbrel	621
Folic acid	336
Lansoprazole	156
Prednisolone	931
Predonine	436
Prograf	170
Remicade	740
Simponi	153
Xeljanz	191

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 RheumatrexThe 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. Rheumatrex: adverse event reports that FDA received. https://reportedreactions.com/drug/rheumatrex/ 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 Rheumatrex as a suspect or interacting product. The 1,961 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 Rheumatrex 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 Rheumatrex?

No. It is a count of what people reported to FDA: 4,266 reports from January 2004 to June 2026. 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?

Physician (56%), pharmacist (18.7%) and consumer or non-health professional (14.3%). 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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