What the label lists and what reports show
Teriflunomide side effects
Teriflunomide's FDA label: “Most common adverse reactions (≥10% and ≥2% greater than placebo): headache, diarrhea, nausea, alopecia, increase in ALT.” FAERS holds 44,957 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is alopecia (6,076 reports).
- Generic listed
- Boxed warning
Check it at the source: the teriflunomide FDA label on DailyMed (effective February 20, 2026, Genzyme Corporation); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of AUBAGIO?AUBAGIO may cause serious side effects, including: see " What is the most important information I should know about AUBAGIO? " decreases in your white blood cell count. Your white blood cell counts should be checked before you start taking AUBAGIO. When you have a low white blood cell count you: may have more frequent infections. You should have a skin test for TB (tuberculosis) before you start taking AUBAGIO. Tell your healthcare provider if you have any of these symptoms of an infection: fever tiredness body aches chills nausea vomiting should not receive certain vaccinations during your treatment with AUBAGIO and for 6 months after your treatment with AUBAGIO ends. allergic reactions. […]
Source: FDA drug label, NDA202992 (Sanofi Aventis Us), as published by Genzyme Corporation, effective February 20, 2026 (SPL set 4650d12c-b9c8-4525-b07f-a2d773eca155), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common adverse reactions (≥10% and ≥2% greater than placebo): headache, diarrhea, nausea, alopecia, increase in ALT.
Table 1: Adverse Reactions in Pooled Placebo-Controlled Studies in Patients with Relapsing Forms of Multiple Sclerosis
| Adverse Reaction | AUBAGIO 7 mg (N=1045) | AUBAGIO 14 mg (N=1002) | Placebo (N=997) |
|---|---|---|---|
| Headache | 18% | 16% | 15% |
| Increase in Alanine aminotransferase | 13% | 15% | 9% |
| Diarrhea | 13% | 14% | 8% |
| Alopecia | 10% | 13% | 5% |
| Nausea | 8% | 11% | 7% |
| Paresthesia | 8% | 9% | 7% |
| Arthralgia | 8% | 6% | 5% |
| Neutropenia | 4% | 6% | 2% |
| Hypertension | 3% | 4% | 2% |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe following clinically significant adverse reactions are described elsewhere in the prescribing information: Hepatotoxicity [see Contraindications (4) and Warnings and Precautions (5.1) ] Bone Marrow Effects/Immunosuppression Potential/Infections [see Warnings and Precautions (5.4) ] Hypersensitivity Reactions [see Contraindications (4) and Warnings and Precautions (5.5) ] Serious Skin Reactions [see Warnings and Precautions (5.6) ] Drug Reaction with Eosinophilia and Systemic Symptoms [see Warnings and Precautions (5.7) ] Cutaneous or Mucocutaneous Ulcers and Impaired Wound Healing [see Warnings and Precautions (5.8) ] Peripheral Neuropathy [see Warnings and Precautions (5.9) ] Increased Blood Pressure [see Warnings and Precautions (5.10) ] Respiratory Effects [see Warnings and Precautions (5.11) ] Pancreatitis in Pediatric Patients [see Warnings and Precautions (5.12) ] Most common adverse reactions (≥10% and ≥2% greater than placebo): headache, diarrhea, nausea, alopecia, increase in ALT. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Genzyme Corporation at 1-800-745-4447 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. …
Source: FDA drug label, NDA202992 (Sanofi Aventis Us), as published by Genzyme Corporation, effective February 20, 2026 (SPL set 4650d12c-b9c8-4525-b07f-a2d773eca155), via openFDA; the full label on DailyMed
What do FAERS reports show?
44,957 reports list teriflunomide among the medicines taken, each a report of something that happened, not proof the medicine caused it; 726 are coded as a death and 6,374 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 20 reactions below, 7 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Teriflunomide: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions