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Teriflunomide side effects: what 44,957 FDA adverse event reports show

Teriflunomide · 1,116 reaction terms · 160,260 drug–reaction co-reports · data 2026-09-14
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Drug class

Pyrimidine Synthesis Inhibitor

FDA label (Established Pharmacologic Class)

Who reports

44,957 reports · 43% serious · 726 with death outcome · 80% female

openFDA FAERS counts, all years, deduplication not applied

Used for

Teriflunomide tablets are indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. Teriflunomide is pyrimidine .

FDA label, Indications and Usage

What it is

Teriflunomide is an oral de novo pyrimidine synthesis inhibitor of the DHO-DH enzyme, with the chemical name (Z)-2-Cyano-3-hydroxy-but-2-enoic acid-(4-trifluoromethylphenyl)-amide.

FDA label, Description section

Boxed warning

HEPATOTOXICITY and EMBRYOFETAL TOXICITY Hepatotoxicity Clinically significant and potentially life-threatening liver injury, including acute liver failure requiring transplant, has been reported in patients treated with teriflunomide in the postmarketing setting [see Warnings and Precautions ( 5.1 )] .

FDA label
How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation. Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)? That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.

Causality screen of the 40 strongest signals

Labeled adverse reaction 2Labeled (related wording) 3Likely indication confounding 6Reporting / coding artifact 2Lab value / disease marker 4Not in label — unassessed 23
What the badges mean

Strongest disproportionality signals

Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only (and, for the 300 most-reported drugs, adjusted for age band), and flags pairs whose reports are unusually skewed by sex or come mostly from consumers. Each row also shows the PRR against the other drugs of the same FDA class, which removes most confounding by the condition being treated, and a calibrated p-value: on validation, known non-causes average an ROR of about 2, so significance is judged against that empirical null (✓ = p < 0.05 after calibration). 1,076 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.

Show:
ReactionReportsPRR 95% CI · ROR · χ²/pEBGM EB05 · IC025Label screenSerious-only & strataTrial cross-check
Band sensation9637.8
30.7–46.6ROR 37.9 · calibrated p 8e-5 ✓
34.8 EB05 29.4 · IC025 +4.6
3/3 methods agree
Not in label — unassessedserious n=69 · 72% consumernot reported in cached trials
Relapsing multiple sclerosis1727.4
16.8–44.7ROR 27.4 · calibrated p 8e-4 ✓
25.2 EB05 16.6 · IC025 +3.1
3/3 methods agree
Likely indication confounding
term in indications; also in warnings
serious n=16not reported in cached trials
Nuclear magnetic resonance imaging abnormal17625.7
22.1–29.9ROR 25.8 · calibrated p 6e-4 ✓
24.4 EB05 21.5 · IC025 +4.3
3/3 methods agree
Reporting / coding artifactserious n=147 · 81% consumernot reported in cached trials
Progressive multiple sclerosis6025.1
19.4–32.6ROR 25.2 · calibrated p 8e-4 ✓
23.7 EB05 19.1 · IC025 +3.9
3/3 methods agree
Likely indication confounding
term in indications; also in warnings
serious n=56not reported in cached trials
Jc virus test positive4123.5
17.2–32.2ROR 23.5 · calibrated p 0.001 ✓
22.2 EB05 17.1 · IC025 +3.6
3/3 methods agree
Lab value / disease markerserious n=32 · 78% consumernot reported in cached trials
Secondary progressive multiple sclerosis9123.5
19.0–29.0ROR 23.5 · calibrated p 0.001 ✓
22.3 EB05 18.7 · IC025 +4.0
3/3 methods agree
Likely indication confounding
term in indications; also in warnings
serious n=86not reported in cached trials
Decreased interest28223.4
20.7–26.3ROR 23.5 · calibrated p 1e-3 ✓
22.2 EB05 20.1 · IC025 +4.2
3/3 methods agree
Not in label — unassessedserious n=109 · 75% consumernot reported in cached trials
Eosinophilic colitis1723.1
14.2–37.6ROR 23.1 · calibrated p 0.002 ✓
21.5 EB05 14.1 · IC025 +3.0
3/3 methods agree
Not in label — unassessedserious n=17not reported in cached trials
Multiple sclerosis2,22122.6
21.6–23.5ROR 23.7 · calibrated p 9e-4 ✓
21.5 EB05 20.8 · IC025 +4.4
3/3 methods agree
Likely indication confounding
term in indications; also in warnings
serious PRR 40.4NCT00751881: 1/233 (0.4%) on Teriflunomide; 2/385 (0.5%) control (serious AE)
Relapsing-remitting multiple sclerosis3922.0
16.0–30.4ROR 22.1 · calibrated p 0.002 ✓
20.9 EB05 15.9 · IC025 +3.5
3/3 methods agree
Likely indication confounding
term in indications; also in warnings
serious n=37not reported in cached trials
Bladder disorder42120.6
18.7–22.7ROR 20.8 · calibrated p 0.002 ✓
19.7 EB05 18.2 · IC025 +4.1
3/3 methods agree
Not in label — unassessedserious n=201NCT04338061: 1/581 (0.2%) on Teriflunomide (serious AE)
Expanded disability status scale score increased5220.3
15.4–26.8ROR 20.3 · calibrated p 0.002 ✓
19.3 EB05 15.3 · IC025 +3.6
3/3 methods agree
Lab value / disease markerserious n=52not reported in cached trials
Walking aid user27420.1
17.8–22.7ROR 20.2 · calibrated p 0.002 ✓
19.3 EB05 17.4 · IC025 +4.0
3/3 methods agree
Not in label — unassessedserious n=235 · 73% consumernot reported in cached trials
Jc polyomavirus test positive4819.8
14.8–26.4ROR 19.8 · calibrated p 0.003 ✓
18.9 EB05 14.8 · IC025 +3.5
3/3 methods agree
Lab value / disease markerserious n=36not reported in cached trials
Primary progressive multiple sclerosis1818.0
11.2–28.8ROR 18.0 · calibrated p 0.005 ✓
16.8 EB05 10.9 · IC025 +2.8
3/3 methods agree
Likely indication confounding
term in indications; also in warnings
serious n=17not reported in cached trials
Throat clearing13617.7
14.9–21.0ROR 17.7 · calibrated p 0.004 ✓
17.0 EB05 14.7 · IC025 +3.7
3/3 methods agree
Not in label — unassessedserious n=79not reported in cached trials
Trigeminal neuralgia13916.7
14.1–19.7ROR 16.7 · calibrated p 0.005 ✓
16.1 EB05 13.9 · IC025 +3.7
3/3 methods agree
Not in label — unassessedserious n=97 · 73% consumernot reported in cached trials
Wheelchair user14515.6
13.2–18.4ROR 15.7 · calibrated p 0.006 ✓
15.1 EB05 13.1 · IC025 +3.6
3/3 methods agree
Not in label — unassessedserious n=134 · 79% consumernot reported in cached trials
Muscle spasticity39815.4
14.0–17.1ROR 15.6 · calibrated p 0.006 ✓
15.0 EB05 13.8 · IC025 +3.7
3/3 methods agree
Not in label — unassessedserious PRR 14.0not reported in cached trials
Alopecia (hair loss)6,07614.8
14.5–15.2ROR 17.0 · calibrated p 0.004 ✓
14.4 EB05 14.1 · IC025 +3.8
3/3 methods agree
Labeled adverse reaction
exact term
serious PRR 13.7 · 71% consumerNCT00751881: 5/233 (2.1%) on Teriflunomide; 16/385 (4.2%) control
Magnetic resonance imaging abnormal3614.7
10.5–20.5ROR 14.7 · calibrated p 0.009 ✓
14.0 EB05 10.4 · IC025 +3.0
3/3 methods agree
Reporting / coding artifactserious n=25not reported in cached trials
Peroneal nerve palsy17214.5
12.5–16.9ROR 14.6 · calibrated p 0.008 ✓
14.1 EB05 12.4 · IC025 +3.5
3/3 methods agree
Not in label — unassessedserious n=115 · 77% consumernot reported in cached trials
Meningoencephalitis herpetic1313.7
7.9–23.8ROR 13.7 · calibrated p 0.016 ✓
12.0 EB05 6.7 · IC025 +2.3
3/3 methods agree
Not in label — unassessedserious n=13not reported in cached trials
Optic neuritis25813.6
12.0–15.3ROR 13.6 · calibrated p 0.011 ✓
13.2 EB05 11.9 · IC025 +3.5
3/3 methods agree
Not in label — unassessedserious PRR 19.7not reported in cached trials
Central nervous system lesion37112.8
11.6–14.2ROR 12.9 · calibrated p 0.013 ✓
12.5 EB05 11.4 · IC025 +3.5
3/3 methods agree
Not in label — unassessedserious PRR 17.7 · 71% consumernot reported in cached trials
Bladder catheterisation2512.4
8.3–18.4ROR 12.4 · calibrated p 0.019 ✓
11.4 EB05 7.8 · IC025 +2.6
3/3 methods agree
Not in label — unassessedserious n=21 · 100% consumernot reported in cached trials
Dysgraphia15811.4
9.7–13.3ROR 11.4 · calibrated p 0.021 ✓
11.0 EB05 9.6 · IC025 +3.2
3/3 methods agree
Not in label — unassessedserious n=139 · 84% consumernot reported in cached trials
Vitamin d increased1410.8
6.4–18.4ROR 10.8 · calibrated p 0.035 ✓
9.1 EB05 5.4 · IC025 +2.1
3/3 methods agree
Lab value / disease markerserious n=11not reported in cached trials
Hypoaesthesia (numbness)3,17210.1
9.7–10.4ROR 10.8 · calibrated p 0.025 ✓
9.9 EB05 9.6 · IC025 +3.2
3/3 methods agree
Not in label — unassessedserious PRR 11.6NCT00751881: 1/371 (0.3%) on Teriflunomide (serious AE)
Heat exhaustion169.9
6.0–16.2ROR 9.9 · calibrated p 0.044 ✓
8.4 EB05 5.2 · IC025 +2.1
3/3 methods agree
Not in label — unassessedserious n=12not reported in cached trials
Balance disorder1,7869.8
9.4–10.3ROR 10.2 · calibrated p 0.030 ✓
9.6 EB05 9.2 · IC025 +3.2
3/3 methods agree
Not in label — unassessedserious PRR 12.4not reported in cached trials
Temperature intolerance1928.9
7.7–10.3ROR 9.0 · calibrated p 0.048 ✓
8.7 EB05 7.7 · IC025 +2.9
3/3 methods agree
Not in label — unassessedserious n=128 · 78% consumernot reported in cached trials
Bladder dysfunction198.8
5.6–13.8ROR 8.8 · calibrated p 0.062
7.5 EB05 5.0 · IC025 +2.1
3/3 methods agree
Not in label — unassessedserious n=13not reported in cached trials
Fine motor skill dysfunction538.7
6.6–11.4ROR 8.7 · calibrated p 0.055
8.2 EB05 6.4 · IC025 +2.5
3/3 methods agree
Not in label — unassessedserious n=36not reported in cached trials
Paraesthesia (tingling/numbness)2,8148.5
8.2–8.8ROR 9.0 · calibrated p 0.047 ✓
8.3 EB05 8.1 · IC025 +3.0
3/3 methods agree
Labeled adverse reaction
exact term
serious PRR 9.9NCT00751881: 4/233 (1.7%) on Teriflunomide; 23/385 (6.0%) control
Functional gastrointestinal disorder618.3
6.5–10.7ROR 8.3 · calibrated p 0.062
7.9 EB05 6.3 · IC025 +2.5
3/3 methods agree
Not in label — unassessedserious n=32not reported in cached trials
Sensory disturbance2818.3
7.3–9.3ROR 8.3 · calibrated p 0.060
8.1 EB05 7.3 · IC025 +2.8
3/3 methods agree
Not in label — unassessedserious PRR 8.6not reported in cached trials

Trial evidence (ClinicalTrials.gov)

✓ Trial adverse-event data found on ClinicalTrials.gov

Largest completed trials with posted results that list Teriflunomide as a study intervention. The right-hand column of the signal table shows whether each FAERS term was also recorded in these trials, with a real denominator (6 of 40 signal terms matched).

Caveats: trial populations, doses and follow-up differ from the reporting population; AE terms are sponsor-coded and matched here by wording; absence from a trial list means the term was not reported above the sponsor's frequency threshold, not that it cannot occur.

Most frequently reported reactions

By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.

ReactionReportsPRR 95% CI · ROR · χ²/pEBGM EB05 · IC025Label screenSerious-only & strataTrial cross-check
Alopecia (hair loss)6,07614.8
14.5–15.2ROR 17.0 · calibrated p 0.004 ✓
14.4 EB05 14.1 · IC025 +3.8
3/3 methods agree
Labeled adverse reaction
exact term
serious PRR 13.7 · 71% consumerNCT00751881: 5/233 (2.1%) on Teriflunomide; 16/385 (4.2%) control
Fatigue (tiredness)4,7652.9
2.8–3.0ROR 3.1 · calibrated p 0.596
2.9 EB05 2.8 · IC025 +1.5
3/3 methods agree
Labeled adverse reaction
exact term
serious PRR 3.6NCT00751881: 6/233 (2.6%) on Teriflunomide; 40/385 (10.4%) control
Diarrhoea (diarrhea)4,7593.5
3.4–3.6ROR 3.8 · calibrated p 0.425
3.5 EB05 3.4 · IC025 +1.7
3/3 methods agree
Labeled adverse reaction
exact term
serious PRR 3.4NCT00751881: 1/371 (0.3%) on Teriflunomide (serious AE)
Fall3,3424.7
4.6–4.9ROR 5.0 · calibrated p 0.232
4.7 EB05 4.6 · IC025 +2.2
3/3 methods agree
Not in label — unassessedserious PRR 4.3 · 71% consumerNCT00751881: 2/409 (0.5%) on Teriflunomide; 2/385 (0.5%) control (serious AE)
Hypoaesthesia (numbness)3,17210.1
9.7–10.4ROR 10.8 · calibrated p 0.025 ✓
9.9 EB05 9.6 · IC025 +3.2
3/3 methods agree
Not in label — unassessedserious PRR 11.6NCT00751881: 1/371 (0.3%) on Teriflunomide (serious AE)
Headache3,0032.2
2.2–2.3ROR 2.3 · calibrated p 0.888
2.2 EB05 2.2 · IC025 +1.1
3/3 methods agree
Labeled adverse reaction
exact term
serious PRR 2.7NCT00751881: 1/371 (0.3%) on Teriflunomide; 3/385 (0.8%) control (serious AE)
Drug ineffective (drug did not work)2,8191.0
1.0–1.0ROR 1.0 · calibrated p 0.306
1.0 EB05 1.0 · IC025 -0.1
PRR-only: not supported by EBGM or IC
Reporting / coding artifactserious PRR 1.4not reported in cached trials
Paraesthesia (tingling/numbness)2,8148.5
8.2–8.8ROR 9.0 · calibrated p 0.047 ✓
8.3 EB05 8.1 · IC025 +3.0
3/3 methods agree
Labeled adverse reaction
exact term
serious PRR 9.9NCT00751881: 4/233 (1.7%) on Teriflunomide; 23/385 (6.0%) control
Nausea2,7461.6
1.6–1.7ROR 1.7 · calibrated p 0.748
1.6 EB05 1.6 · IC025 +0.6Labeled adverse reaction
exact term
serious PRR 2.1 · 71% consumerNCT00751881: 8/233 (3.4%) on Teriflunomide; 27/385 (7.0%) control
Gait disturbance2,4896.1
5.9–6.4ROR 6.4 · calibrated p 0.126
6.0 EB05 5.8 · IC025 +2.5
3/3 methods agree
Not in label — unassessedserious PRR 8.1 · 73% consumernot reported in cached trials
Pain2,2361.7
1.6–1.8ROR 1.7 · calibrated p 0.790
1.7 EB05 1.6 · IC025 +0.7Labeled adverse reaction
exact term
serious PRR 2.2NCT00751881: 1/371 (0.3%) on Teriflunomide (serious AE)
Multiple sclerosis2,22122.6
21.6–23.5ROR 23.7 · calibrated p 9e-4 ✓
21.5 EB05 20.8 · IC025 +4.4
3/3 methods agree
Likely indication confounding
term in indications; also in warnings
serious PRR 40.4NCT00751881: 1/233 (0.4%) on Teriflunomide; 2/385 (0.5%) control (serious AE)
Condition aggravated2,0163.1
3.0–3.3ROR 3.2 · calibrated p 0.557
3.1 EB05 3.0 · IC025 +1.6
3/3 methods agree
Reporting / coding artifactserious PRR 3.7not reported in cached trials
Depression1,7903.7
3.5–3.8ROR 3.8 · calibrated p 0.420
3.7 EB05 3.5 · IC025 +1.8
3/3 methods agree
Not in label — unassessedserious PRR 3.3 · 71% consumerNCT00751881: 1/267 (0.4%) on Teriflunomide; 1/385 (0.3%) control (serious AE)

Unlabeled candidate signals

These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.

Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.

Common questions

What are the most reported side effects of Teriflunomide?

In FDA FAERS, the most frequently co-reported reaction terms for Teriflunomide are alopecia, multiple sclerosis relapse, fatigue, diarrhoea, fall, hypoaesthesia. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.

Does Teriflunomide have an FDA boxed warning?

Yes. The current FDA label carries a boxed warning: HEPATOTOXICITY and EMBRYOFETAL TOXICITY Hepatotoxicity Clinically significant and potentially life-threatening liver injury, including acute liver failure requiring transplant, has been reported in patients treated with teriflunomide in the postmarketing setting [see Warnings and Precautions ( 5.1 )] .

Do FAERS signals prove that Teriflunomide causes these side effects?

No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.

Sources & methods

Page generated 2026-10-14. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.