Tofacitinib adverse event reports that FDA received

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

Name type: Generic name
Class: Janus kinase inhibitor

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 July 2012 to June 2026, FDA received 4,874 adverse event reports that name Tofacitinib. In these reports the drug is a suspect or interacting product.

In the same period, 2,084 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 860 reports in the 12 months to June 2026 and 1,058 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, 860 (0.1%) name Tofacitinib. Reports from other health professionals were 69.8% of the reports that name Tofacitinib and 19.7% 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 Tofacitinib 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 160 reports that name Tofacitinib.
In January to March 2026, FDA received 165.
In April to June 2025, FDA received 238.

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 606 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 4,854 of the 4,874 reports (99.6%).

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 606 terms.

Reaction terms in the reports that name Tofacitinib, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 4,874 reports
Drug ineffectivethe medicine did not work as expected	2,168	44.5%
Off label useused for a purpose or in a way not on the label	1,726	35.4%
Rheumatoid arthritisrheumatoid arthritis, an inflammatory joint disease	1,673	34.3%
Painpain, site not specified	1,511	31%
Drug intolerancethe medicine was not tolerated	1,493	30.6%
Fatiguetiredness	1,435	29.4%
Rashskin rash	1,406	28.8%
Joint swellinga swollen joint	1,404	28.8%
Synovitis	1,381	28.3%
Abdominal discomfortstomach discomfort	1,351	27.7%
Alopeciahair loss	1,351	27.7%
Pemphigus	1,342	27.5%
Swelling	1,342	27.5%
Arthropathy	1,333	27.3%
Glossodynia	1,332	27.3%
Wound	1,331	27.3%
Hepatic enzyme increasedraised liver enzymes	1,327	27.2%
Systemic lupus erythematosuslupus, an autoimmune disease	1,323	27.1%
Treatment failurethe treatment did not work	1,323	27.1%
Infusion related reactiona reaction during or soon after an infusion	1,317	27%
Arthralgiajoint pain	1,303	26.7%
Condition aggravatedthe condition being treated got worse	1,296	26.6%
Hand deformity	1,290	26.5%
Contraindicated product administered	1,284	26.3%
Pericarditisinflammation of the sac around the heart	1,255	25.7%
Anti-cyclic citrullinated peptide antibody positive	1,197	24.6%
Maternal exposure during pregnancythe mother took the medicine during pregnancy	1,194	24.5%
Discomfort	1,132	23.2%
Hypersensitivityan allergic-type reaction	1,131	23.2%
General physical health deteriorationgeneral decline in health	1,071	22%
Blood cholesterol increasedraised cholesterol	997	20.5%
Helicobacter infection	969	19.9%
Headachehead pain	966	19.8%
Type 2 diabetes mellitustype 2 diabetes	962	19.7%
Duodenal ulcer perforation	955	19.6%
Product use issuea problem in how the product was used	939	19.3%
Hypertensionhigh blood pressure	923	18.9%
Therapeutic product effect decreased	891	18.3%
Musculoskeletal stiffnessstiffness in muscles or joints	889	18.2%
Mobility decreasedreduced ability to move about	886	18.2%
Vomitingbeing sick	885	18.2%
Blistera blister	879	18%
Nauseafeeling sick	807	16.6%
Weight increasedweight gain	799	16.4%
Peripheral swellingswelling of the arms or legs	790	16.2%
Rheumatoid factor positive	786	16.1%
Psoriatic arthropathy	738	15.1%
Rheumatic fever	737	15.1%
Folliculitis	723	14.8%
Intentional product use issuedeliberate use not as intended	723	14.8%

Download all 606 terms of Tofacitinib (CSV)

The counts add to more than 4,874 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.

Same ingredient, other names

Reporters write a brand name or a generic name. Each name has its own page and its own count.

Names of Tofacitinib with a page, in the order generic names, brand names, names as reported
Name	Name type	Reports
Tofacitinib (this page)	Generic name	4,874
Tofacitinib citrate	Generic name	5,775
Xeljanz	Brand name	156,082

Sum of the separately reported names: 166,731. A report that names two of these names is in the sum two times. The sum is not the number of reports for the ingredient.

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.

Outcomes by year

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

Outcomes in the reports that name Tofacitinib, 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
2012	4	4	0	0	1	0	0	3	0
2013	4	4	0	1	4	0	0	0	0
2014	6	5	1	0	3	0	0	4	1
2015	6	2	0	0	1	0	0	1	4
2016	35	24	1	0	8	0	1	16	11
2017	45	32	5	1	12	3	0	20	13
2018	67	49	3	1	17	0	1	38	18
2019	118	91	3	4	22	6	1	77	27
2020	299	287	6	15	43	33	2	266	12
2021	564	553	14	42	85	177	8	501	11
2022	660	624	46	61	152	141	2	561	36
2023	494	469	93	139	176	146	20	429	25
2024	824	767	356	395	461	385	195	713	57
2025	1,179	1,151	701	657	749	672	443	1,050	28
2026	569	547	372	356	383	344	262	513	22

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 Tofacitinib, 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 Tofacitinib, by the year in which FDA received them
Year	Reports
2012	5
2013	4
2014	5
2015	11
2016	53
2017	61
2018	101
2019	161
2020	408
2021	600
2022	594
2023	536
2024	923
2025	1,087
2026	325

Reports that name Tofacitinib, 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 Tofacitinib
Age	Reports	Share
Under 2	14	0.3%
2 to 11	114	2.3%
12 to 17	56	1.1%
18 to 44	1,804	37%
45 to 64	706	14.5%
65 to 74	289	5.9%
75 and over	146	3%
Age not given	1,745	35.8%

Sex of the patient in the reports that name Tofacitinib
Sex	Reports	Share
Female	3,316	68%
Male	704	14.4%
Unknown or not given	854	17.5%

Type of reporter in the reports that name Tofacitinib
Reporter	Reports	Share
Physician	1,032	21.2%
Pharmacist	40	0.8%
Other health professional	3,403	69.8%
Lawyer	1	under 0.1%
Consumer or non-health professional	387	7.9%
Not given	11	0.2%

Age and sex are as the report gives them. The reporter is the primary source in the report. 15.3% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Tofacitinib record
Indication as recorded (MedDRA)	Reports	Share
Rheumatoid arthritis	1,934	39.7%
Colitis ulcerative	207	4.2%
Dermatomyositis	136	2.8%
Psoriatic arthropathy	92	1.9%
Still's disease	81	1.7%
Interstitial lung disease	41	0.8%

The reporter fills in the indication, and the field is often empty. Each share is of all 4,874 reports.

Drugs in the same reports

Other drugs that the reports of Tofacitinib name, in any role, in order of name
Drug	Reports that name the two
Actemra	2,250
Enbrel	2,456
Humira	2,329
Leflunomide	2,342
Methotrexate	3,438
Orencia	2,432
Prednisone	2,884
Rituximab	2,742
Simponi	2,309
Sulfasalazine	2,764

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.

Pages near this one

Tofacitinib citrate same ingredient
Xeljanz same ingredient
Ruxolitinib same class
Rinvoq same class
Upadacitinib same class
Opzelura same class
Tocopherol next in the A to Z list
Tocilizumab next in the A to Z list
Tofranil next in the A to Z list
Tobrex next in the A to Z list
Tolep next in the A to Z list
Tobramycin and dexamethasone next in the A to Z list

These links are for navigation. No count selected them. The class page lists each drug of the class.

Official pages

DailyMed labels for TofacitinibThe 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. Tofacitinib: adverse event reports that FDA received. https://reportedreactions.com/drug/tofacitinib/ 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 Tofacitinib as a suspect or interacting product. The 2,084 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 Tofacitinib 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 Tofacitinib?

No. It is a count of what people reported to FDA: 4,874 reports from July 2012 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?

Other health professional (69.8%), physician (21.2%) and consumer or non-health professional (7.9%). 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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