What are the most common side effects of TERIFLUNOMIDE?

Reported side effects vary by individual. The side-effects section on this page lists the events most frequently reported to FDA FAERS for TERIFLUNOMIDE. FAERS is voluntary reporting, so it reflects what was reported, not absolute incidence.

Is TERIFLUNOMIDE the same as Teriflunomide?

Teriflunomide is a brand name for TERIFLUNOMIDE. They share the same active ingredient and FDA-approved indications. Biosimilars and authorised generics may differ in inactive ingredients such as buffers or preservatives.

TERIFLUNOMIDE

Q: What is TERIFLUNOMIDE used for?

TERIFLUNOMIDE (brand name Teriflunomide) is a DMARD indicated for 1 INDICATIONS AND USAGE Teriflunomide tablets are indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease.

Q: How does TERIFLUNOMIDE work?

TERIFLUNOMIDE works through the following mechanism: 12.1 Mechanism of Action Teriflunomide, an immunomodulatory agent with anti-inflammatory properties, inhibits dihydroorotate dehydrogenase, a mitochondrial enzyme involved in de novo pyrimidine synthesis. The exact mechanism by which teriflunomide exerts its therapeutic effect in multiple sclerosis is unknown but may involve a reduction in the number of activated lymphocytes in CNS..

DMARD

Brand names: Teriflunomide, Aubagio

Oral

Mechanism of Action

12.1 Mechanism of Action Teriflunomide, an immunomodulatory agent with anti-inflammatory properties, inhibits dihydroorotate dehydrogenase, a mitochondrial enzyme involved in de novo pyrimidine synthesis. The exact mechanism by which teriflunomide exerts its therapeutic effect in multiple sclerosis is unknown but may involve a reduction in the number of activated lymphocytes in CNS.

Indications

1 INDICATIONS AND USAGE 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 tablets are a pyrimidine synthesis inhibitor indicated for the treatment of relapsing forms of multiple sclerosis (MS)

to include clinically isolated syndrome

Contraindications

• 5.3) and Use in Specific Populations (8.1) ] . • Patients with a history of a hypersensitivity reaction to teriflunomide
• leflunomide
• or to any of the inactive ingredients in teriflunomide tablets. Reactions have included anaphylaxis
• angioedema
• and serious skin reactions [see Warnings and Precautions (5.5) ]. • Coadministration with leflunomide [see Clinical Pharmacology (12.3) ]. • Severe hepatic impairment ( 4

FDA Warnings

5 WARNINGS AND PRECAUTIONS • Elimination of teriflunomide tablets can be accelerated by administration of cholestyramine or activated charcoal for 11 days
Consider suspending treatment with teriflunomide tablets in case of serious infection
Patients with pre-existing liver disease and patients taking other hepatotoxic drugs may be at increased risk for developing liver injury when taking teriflunomide tablets
Teriflunomide tablets are contraindicated in patients with severe hepatic impairment [see Contraindications (4) ]

Known Side Effects

10 documented side effects by frequency

Hair Loss

>10%

Fatigue

1-10%

Diarrhea

1-10%

Falls

1-10%

Headache

1-10%

Drug Not Working

1-10%

Tingling/Numbness

1-10%

Nausea

1-10%

Condition Worsened

0.1-1%

Depression

0.1-1%

Community Discussions

No community discussions found for TERIFLUNOMIDE yet.

Primary sources

Every figure on this page links back to its primary source. See data sources for full provenance.

DailyMed FDA label search → TERIFLUNOMIDE openFDA label JSON → TERIFLUNOMIDE FAERS adverse-event reports → TERIFLUNOMIDE ClinicalTrials.gov → completed Phase 2+ trials of TERIFLUNOMIDE

Compare With

13 available comparisons

Formulations

Dosage Forms

Tablet

Route

Oral