Teriflunomide adverse event reports that FDA received

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

Name type: Generic name
Class: Pyrimidine synthesis 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 February 2013 to June 2026, FDA received 4,984 adverse event reports that name Teriflunomide. In these reports the drug is a suspect or interacting product.

In the same period, 297 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 334 reports in the 12 months to June 2026 and 387 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, 334 (under 0.1%) name Teriflunomide. Reports for patients aged 45 to 64 were 47.3% of the reports that name Teriflunomide and 20% 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 Teriflunomide 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 87 reports that name Teriflunomide.
In January to March 2026, FDA received 96.
In April to June 2025, FDA received 84.

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 642 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 4,973 of the 4,984 reports (99.8%).

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 642 terms.

Reaction terms in the reports that name Teriflunomide, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 4,984 reports
Alopeciahair loss	824	16.5%
Fatiguetiredness	820	16.5%
Diarrhoealoose or frequent stools	761	15.3%
Multiple sclerosis relapsea flare of multiple sclerosis	632	12.7%
Hypoaesthesianumbness	593	11.9%
Falla fall	553	11.1%
Headachehead pain	539	10.8%
Condition aggravatedthe condition being treated got worse	538	10.8%
Paraesthesiatingling or pins and needles	502	10.1%
Gait disturbancedifficulty walking	495	9.9%
Memory impairmentmemory problems	474	9.5%
Nauseafeeling sick	470	9.4%
Painpain, site not specified	449	9%
Astheniaweakness or lack of energy	349	7%
Cough	348	7%
Multiple sclerosis	348	7%
Balance disorderproblems with balance	342	6.9%
Pain in extremitypain in an arm or leg	342	6.9%
Product dose omissiona dose was missed	324	6.5%
Dizzinesslight-headedness or unsteadiness	306	6.1%
Depressionlow mood	298	6%
Drug ineffectivethe medicine did not work as expected	268	5.4%
Feeling abnormalfeeling odd or not right	249	5%
Muscular weaknessmuscle weakness	244	4.9%
Back pain	234	4.7%
Malaisegeneral feeling of being unwell	233	4.7%
Unevaluable eventthe event could not be assessed	229	4.6%
Weight decreasedweight loss	222	4.5%
Muscle spasmsmuscle cramps	220	4.4%
Visual impairmentreduced vision	211	4.2%
Dyspnoeashortness of breath	204	4.1%
Nasopharyngitisa cold	203	4.1%
Hypertensionhigh blood pressure	199	4%
Insomniadifficulty sleeping	195	3.9%
Pruritusitching	194	3.9%
Abdominal discomfortstomach discomfort	191	3.8%
Arthralgiajoint pain	186	3.7%
Urinary tract infectionbladder or urinary infection	179	3.6%
Vomitingbeing sick	178	3.6%
Product dose omission issuea dose was missed	176	3.5%
Rashskin rash	175	3.5%
Stress	171	3.4%
Blood pressure increaseda raised blood pressure reading	165	3.3%
Mobility decreasedreduced ability to move about	160	3.2%
Anxiety	153	3.1%
Abdominal pain upperupper stomach pain	150	3%
Tremorshaking	142	2.8%
Pyrexiafever	137	2.7%
Cognitive disorderproblems with thinking or memory	128	2.6%
Decreased appetitereduced appetite	122	2.4%

Download all 642 terms of Teriflunomide (CSV)

The counts add to more than 4,984 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 Teriflunomide with a page, in the order generic names, brand names, names as reported
Name	Name type	Reports
Teriflunomide (this page)	Generic name	4,984
Aubagio	Brand name	36,990

Sum of the separately reported names: 41,974. 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 Teriflunomide, 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
2013	7	2	0	0	2	0	0	0	5
2014	102	88	3	3	51	3	0	44	14
2015	81	64	8	5	36	1	0	30	17
2016	98	82	6	6	55	3	0	35	16
2017	4	4	0	0	2	0	0	2	0
2018	439	292	3	9	131	38	1	266	147
2019	951	472	16	11	192	61	0	419	479
2020	905	516	12	6	205	93	1	459	389
2021	583	471	17	2	173	127	0	392	112
2022	535	330	13	2	131	50	0	284	205
2023	336	253	9	20	82	32	7	206	83
2024	375	335	18	23	123	18	3	240	40
2025	360	316	20	5	115	5	1	229	44
2026	208	184	6	7	62	11	0	121	24

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 Teriflunomide, 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 Teriflunomide, by the year in which FDA received them
Year	Reports
2013	155
2014	463
2015	244
2016	124
2017	195
2018	566
2019	634
2020	346
2021	597
2022	458
2023	310
2024	359
2025	350
2026	183

Reports that name Teriflunomide, 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 Teriflunomide
Age	Reports	Share
Under 2	3	0.1%
2 to 11	3	0.1%
12 to 17	4	0.1%
18 to 44	967	19.4%
45 to 64	2,358	47.3%
65 to 74	486	9.8%
75 and over	85	1.7%
Age not given	1,078	21.6%

Sex of the patient in the reports that name Teriflunomide
Sex	Reports	Share
Female	3,468	69.6%
Male	965	19.4%
Unknown or not given	551	11.1%

Type of reporter in the reports that name Teriflunomide
Reporter	Reports	Share
Physician	1,124	22.6%
Pharmacist	149	3%
Other health professional	646	13%
Lawyer	0	0%
Consumer or non-health professional	2,940	59%
Not given	125	2.5%

Age and sex are as the report gives them. The reporter is the primary source in the report. 71.9% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Teriflunomide record
Indication as recorded (MedDRA)	Reports	Share
Multiple sclerosis	3,079	61.8%
Relapsing-remitting multiple sclerosis	480	9.6%
Multiple sclerosis relapse	164	3.3%
Relapsing multiple sclerosis	59	1.2%
Secondary progressive multiple sclerosis	12	0.2%
Foetal exposure during pregnancy	5	0.1%

The reporter fills in the indication, and the field is often empty. Each share is of all 4,984 reports.

Drugs in the same reports

Other drugs that the reports of Teriflunomide name, in any role, in order of name
Drug	Reports that name the two
Amlodipine	126
Ampyra	181
Atorvastatin	100
Baclofen	301
Calcium	102
Ergocalciferol	330
Gabapentin	326
Lisinopril	134
Omeprazole	133
Vitamin d	189

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

Aubagio same ingredient
Terconazole next in the A to Z list
Teriparatide next in the A to Z list
Tercian next in the A to Z list
Terizidone next in the A to Z list
Terbutaline sulfate next in the A to Z list
Tessalon next in the A to Z list
Terbutaline next in the A to Z list
Testim next in the A to Z list
Terbinafine hydrochloride next in the A to Z list
Testopel next in the A to Z list
Terbinafine hcl 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 TeriflunomideThe 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. Teriflunomide: adverse event reports that FDA received. https://reportedreactions.com/drug/teriflunomide/ 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 Teriflunomide as a suspect or interacting product. The 297 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 Teriflunomide 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 Teriflunomide?

No. It is a count of what people reported to FDA: 4,984 reports from February 2013 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?

Consumer or non-health professional (59%), physician (22.6%) and other health professional (13%). 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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