FDA-filed SPL labeling · retrieved through openFDA

Teriflunomide

Teriflunomide is an oral immunomodulatory tablet used to treat relapsing forms of multiple sclerosis (MS) in adults, available as the brand Aubagio and as generic teriflunomide.

Brand name Aubagio
Drug class ⓘ Pyrimidine Synthesis Inhibitor
Rx Form 1 Route Oral
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 16 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

At a glance
Linked label effectiveFeb 20, 2026
Clinical labels in scope ⓘ16
AvailabilityRx
Earliest approval/marketing year ⓘ2012
FDA-listed product records ⓘ93
Boxed warningYes
How we combine label and product data →
✓No current FDA shortage listed · checked Sep 23, 2026 🚨Recall on record
⭐ Teriflunomide at a glance The quick version — the full detail is in the Patient Information Guide below.
💊
HelloPharmacist Editorial Team Bottom Line
Teriflunomide (Aubagio and generics) is a once-daily oral tablet that helps reduce relapses in adults with relapsing forms of multiple sclerosis. It requires careful monitoring for liver problems and is absolutely not safe during pregnancy. Work closely with your care team on regular blood tests, reliable contraception, and any new symptoms that come up during treatment.
How we write & review this content — our editorial policy →
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾

This medication carries two serious FDA boxed warnings — the most serious type of warning the FDA can require.

Liver damage: Teriflunomide has caused severe liver injury, including acute liver failure requiring transplant, in some patients after the drug was approved. This can happen at any time during treatment. If you develop symptoms like yellowing skin or eyes, dark urine, unusual fatigue, nausea, vomiting, or stomach pain, contact your doctor immediately. Your liver function must be tested before you start and checked monthly for the first six months. Using other medications that are hard on the liver at the same time raises your risk further. People with severe liver disease must not take this drug.

Risk to unborn babies: Teriflunomide can cause birth defects and fetal death. Women who are pregnant or who might become pregnant must not take this medication unless they are using effective contraception. A pregnancy test is required before starting. Because the drug stays in the body for a very long time (up to two years without special treatment), effective birth control must continue even after stopping — until blood tests confirm the drug has cleared. If you become pregnant while taking teriflunomide, stop it immediately and contact your doctor to begin an elimination procedure. Men who want to father a child should also speak to their doctor about stopping the drug and clearing it from their system.

Read the full warning on DailyMed →

📖 Teriflunomide: Patient Information Guide

A plain-language walkthrough of Teriflunomide — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.

🎯What it's used for▾

Teriflunomide tablets are approved for adults with relapsing forms of multiple sclerosis (MS). This covers several distinct MS presentations:

  • Clinically isolated syndrome (CIS) — a first episode of neurological symptoms that may be a sign of MS
  • Relapsing-remitting MS — the most common pattern, with defined attacks followed by recovery periods
  • Active secondary progressive MS — a later phase of the disease that still shows relapses or new MRI activity

Aubagio (the brand-name film-coated tablet) and generic teriflunomide film-coated and uncoated tablets all carry this same indication for adults.

⚙️How it works▾

Teriflunomide is an immunomodulatory agent — meaning it adjusts how the immune system behaves rather than shutting it down completely. It works by blocking a mitochondrial enzyme called dihydroorotate dehydrogenase (DHODH), which activated immune cells (lymphocytes) need to make new copies of themselves. By limiting this process, teriflunomide reduces the number of overactive immune cells that can travel to the brain and spinal cord and trigger the inflammation that drives MS relapses. The exact sequence of events that leads to benefit in MS isn't fully mapped out, but reducing these activated lymphocytes in the central nervous system is thought to be the key mechanism.

💊How it's taken▾

Teriflunomide tablets are taken once a day by mouth. They can be taken with or without food — eating does not meaningfully change how the drug is absorbed. Your prescriber will choose the appropriate strength for you. Because the drug builds up in the body slowly and takes about three months to reach a stable level, consistency matters — try to take it at the same time each day. Follow your prescriber's and pharmacist's instructions on what to do if you miss a dose.

🤒Side effects — in detail▾

The most commonly reported side effects in clinical trials included:

  • Headache
  • Diarrhea
  • Nausea
  • Hair thinning or hair loss (alopecia)
  • Elevated liver enzymes (ALT) on blood tests
  • Tingling or numbness (paresthesia)
  • Joint pain (arthralgia)
  • Low neutrophil count (neutropenia)
  • High blood pressure (hypertension)

More serious reactions — including severe liver injury, dangerous skin reactions, serious infections, and interstitial lung disease — have also been reported. Contact your doctor promptly if you develop jaundice (yellowing of skin or eyes), a widespread rash, signs of infection, or breathing difficulties.

⚠️Warnings & precautions▾
  • Liver injury (hepatotoxicity): Severe and potentially fatal liver damage, including cases requiring transplant, has been reported. Liver tests must be done before starting and monitored monthly for the first six months. People with pre-existing liver disease or those on other liver-affecting drugs face higher risk. Stop the drug and contact your doctor immediately if liver-related symptoms appear.
  • Harm to unborn babies (embryofetal toxicity): Teriflunomide causes birth defects and fetal death in animal studies at levels lower than those in humans. It is contraindicated in pregnancy. Reliable contraception is essential during treatment and until blood levels are confirmed safe after stopping.
  • Bone marrow suppression and infection risk: The drug can lower white blood cell and platelet counts. Patients should be screened for tuberculosis before starting, and treatment should be withheld during active infections.
  • Serious skin reactions: Rare but life-threatening skin conditions (Stevens-Johnson syndrome, toxic epidermal necrolysis, DRESS syndrome) have been reported. Stop the drug and seek care immediately for severe rash or blistering.
  • Blood pressure increase: Blood pressure should be measured before and regularly during treatment.
  • Peripheral neuropathy: Nerve damage causing numbness or weakness has occurred. Report new symptoms to your doctor promptly.
  • Interstitial lung disease: Inflammation or scarring of the lungs has been reported. Tell your doctor about new or worsening breathing symptoms.
🔀What it interacts with▾

Teriflunomide affects how several other drugs are processed by the body — always give your pharmacist and doctor a full medication list before starting. Key interactions include:

  • Leflunomide (Arava): Absolutely cannot be combined — teriflunomide is the active form of leflunomide, and using both creates dangerously high levels
  • Warfarin: Teriflunomide can reduce warfarin's blood-thinning effect by about 25% — close monitoring of INR (clotting test) is required
  • Rosuvastatin (Crestor): Teriflunomide significantly raises rosuvastatin levels; the daily dose of rosuvastatin must not exceed 10 mg
  • Other statins (atorvastatin, pravastatin, simvastatin) and nateglinide: Levels may be increased — dose reduction and close monitoring may be needed
  • Repaglinide, pioglitazone, rosiglitazone, paclitaxel (CYP2C8 substrates): Teriflunomide raises their blood levels — monitoring and possible dose adjustment required
  • Duloxetine, theophylline, tizanidine, alosetron (CYP1A2 substrates): Teriflunomide may reduce their effectiveness — monitoring and possible dose adjustment required
  • Certain antibiotics and other OAT3-cleared drugs (ciprofloxacin, methotrexate, furosemide, penicillin G, zidovudine, cefaclor, ketoprofen, cimetidine): Teriflunomide may raise their levels — monitor for increased effects or side effects
  • Oral contraceptives: Teriflunomide can increase hormone levels of some contraceptives — discuss which birth control method to use with your doctor

This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.

📋Before taking it▾
  • Severe liver disease: Teriflunomide is contraindicated — do not use if you have severe hepatic impairment
  • Pregnancy: Contraindicated — do not take if you are pregnant; a negative pregnancy test is required before starting
  • Women who can become pregnant: Effective contraception is mandatory during treatment and until blood levels are confirmed safe after stopping
  • Men planning to father a child: The drug is found in semen; men should discuss stopping the drug and using an accelerated elimination procedure with their doctor
  • Pre-existing liver disease: Increases the risk of liver injury — discuss with your doctor before starting
  • Current leflunomide use: Cannot be combined — leflunomide is converted to teriflunomide in the body
  • Allergy to teriflunomide or leflunomide: Do not take if you have had a hypersensitivity reaction (anaphylaxis, angioedema, serious skin reaction) to either drug
  • Active infections or tuberculosis: TB screening required before starting; treatment should not begin during active infections
  • Breastfeeding: Not recommended — the drug may harm a nursing infant
  • Children and adolescents: Safety and effectiveness have not been established in pediatric patients
  • Older adults (over 65): Clinical studies did not include patients over 65; use with caution and discuss with your doctor
  • Mild or moderate kidney or liver impairment: No dose adjustment needed, but inform your doctor of any kidney or liver conditions
🚑If you take too much▾

There is no documented experience with teriflunomide overdose in humans. In studies, healthy subjects tolerated higher-than-recommended daily doses for up to two weeks without serious problems. In the event of a significant overdose, the recommended approach is to use cholestyramine or activated charcoal to speed up elimination of the drug from the body — the same procedure used when the drug needs to be cleared quickly for other reasons.

📡Pharmacodynamics — effects in the body▾

In a clinical study in healthy adults, teriflunomide did not meaningfully prolong the QT interval (the heart's electrical recovery time) at the doses studied — meaning it is not expected to cause dangerous heart rhythm changes through that mechanism. Its main measurable effect on the immune system is a reduction in activated white blood cells (lymphocytes and neutrophils) circulating in the bloodstream, which was observed in clinical trials with decreases in white blood cell and platelet counts during treatment.

🔬Pharmacokinetics — how your body processes it▾

After an oral dose, teriflunomide reaches peak blood levels within one to four hours, and food does not meaningfully affect absorption. It binds very tightly to blood proteins (over 99%) and is mainly distributed in the bloodstream rather than throughout body tissues. The drug has a very long half-life — about 18 to 19 days — meaning it stays in the body for a long time; it takes roughly three months of daily dosing to reach a stable level. Teriflunomide is cleared mainly through the bile into stool and through the kidneys into urine, and without a special elimination procedure (using cholestyramine or activated charcoal), it can take on average eight months — and up to two years — to fall to very low levels after stopping.

📦How to store it▾

Store at 68°F to 77°F (20°C to 25°C) with excursions permitted between 59°F and 86°F (15°C and 30°C).

📄 Written from Teriflunomide’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →

56

Supplements & herbs that interact with Teriflunomide

56 supplements and herbal products have documented interactions with Teriflunomide in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.

Severity mix
  • Major · 4
  • Moderate · 43
  • Minor · 9
ACTIVATED CHARCOAL Major BEER Major SIBERIAN COCKLEBUR Major WINE Major ASHWAGANDHA Moderate BLACK COHOSH Moderate BOLDO Moderate BUCHU Moderate +48 more
Every supplement checked against Teriflunomide — ranked by severity The full interaction hub: 4 major · 43 moderate · 9 minor · every one linked to its full report. Check Teriflunomide against your exact supplements

Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.

🩺 Pharmacist Counseling Corner

Quick, plain-English answers to the questions patients ask most about Teriflunomide — the kind of thing our pharmacy team would talk through with you at the counter.

What exactly does teriflunomide do for my MS? ▾
Teriflunomide helps reduce relapses in adults with relapsing forms of MS — including relapsing-remitting MS, clinically isolated syndrome, and active secondary progressive MS. It works by limiting the activity of overactive immune cells that travel to the brain and spinal cord and cause the inflammation behind MS attacks. It won't reverse existing damage, but it's designed to reduce how often and how severely relapses happen.
Can I take this medication if I'm pregnant or planning to become pregnant? ▾
No — teriflunomide cannot be taken during pregnancy. It has been shown to cause serious birth defects and fetal death in animal studies. Before you start, your doctor will confirm you're not pregnant. You'll need to use reliable contraception throughout treatment and even after stopping, until a blood test confirms the drug has cleared to a safe level. If you want to become pregnant in the future, talk to your doctor — there's a procedure using cholestyramine or activated charcoal that can speed up how quickly the drug leaves your body. Men who want to father a child also need to discuss this with their doctor.
How will I know if the medication is affecting my liver? ▾
Your doctor will check your liver enzyme levels before you start and then at least once a month for the first six months. Watch for warning signs between appointments: yellowing of your skin or the whites of your eyes (jaundice), unusually dark urine, unexplained fatigue, nausea, vomiting, or pain in your upper right abdomen. If any of those happen, call your doctor right away — don't wait for your next scheduled test.
Are there any medications I absolutely cannot take with teriflunomide? ▾
Yes — you should not take leflunomide (Arava) at the same time, because your body converts leflunomide into teriflunomide, which would push levels to a dangerous range. Beyond that hard stop, several drugs can have their levels significantly changed by teriflunomide, including warfarin, rosuvastatin, and some diabetes and cancer medications. Always give your pharmacist and all your doctors a complete list of everything you take — including over-the-counter products — before starting.
My hair seems to be thinning since I started — is that normal? ▾
Hair thinning and hair loss are among the more commonly reported side effects of teriflunomide — seen in about 10–13% of people in clinical trials. It's frustrating, but it's a known reaction. Let your doctor know it's happening so they can keep an eye on things and rule out other causes. In many cases it's manageable, but your care team may want to review whether the benefit continues to outweigh this side effect for you personally.
If I need to stop taking teriflunomide, does it just clear out on its own? ▾
Not quickly — teriflunomide stays in the body for a very long time because of its long half-life. Without any intervention, it can take an average of eight months, and sometimes up to two years, to fall to very low levels. If you need to clear it faster — for example, because of pregnancy, a serious side effect, or another reason — your doctor can prescribe an 11-day course of cholestyramine or activated charcoal, which speeds up elimination and reduces levels by more than 98%. Don't stop the medication or start the elimination procedure on your own without talking to your doctor first.
Is Teriflunomide available over the counter? ▾
Teriflunomide is dispensed by prescription according to its FDA labeling, so it isn't sold over the counter. Your prescriber and pharmacist will determine if it's appropriate for you.
When was Teriflunomide first available? ▾
Teriflunomide has been available in the United States since at least 2012, based on FDA approval history (Drugs@FDA) and product marketing records.
Who makes Teriflunomide? ▾
Teriflunomide is supplied by 34 manufacturers listed in the FDA NDC Directory, including Msn Laboratories Private Limited, Genzyme Corporation, Zydus Lifesciences Limited.

💬 Answers drafted from Teriflunomide’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →

🧰 Keep exploring

📊Teriflunomide supplement interactions56 checked — ranked by severity 🌿Drug & Supplement CheckerTeriflunomide vs. vitamins & herbs 💬Ask a PharmacistFree answer, usually < 24h 🔎NDC & pricing lookupFind Teriflunomide NDCs & costs 🅰️Browse Drugs A–ZLook up any medication

💊 How Teriflunomide comes

Teriflunomide is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Tablet

By mouth
Brands Aubagio
How this form is used
What it may be used for
  • Aubagio (teriflunomide) tablet is used to treat relapsing forms of MS in adults, including clinically isolated syndrome, relapsing-remitting MS, and active secondary progressive MS
  • Generic teriflunomide tablets are indicated for the same relapsing forms of MS in adults
Important instructions
  • Aubagio and teriflunomide tablets are taken by mouth once daily, with or without food
  • Liver function tests (transaminase and bilirubin) must be obtained within 6 months before starting, and ALT monitored at least monthly for the first 6 months of treatment
  • A complete blood count (CBC) should be obtained within 6 months before starting; blood pressure should be checked before starting and periodically during treatment
  • Pregnancy must be excluded before starting treatment in females of reproductive potential; effective contraception is required during treatment
Available strengths 3 strengths
7 mg 14 mg 14 mg/141
81 FDA-listed product records ⓘ

📊 Teriflunomide across the U.S. market

How Teriflunomide appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

1
Dose forms ⓘ
34
Manufacturers
2
Brand names
93
FDA-listed product records ⓘ
2012
First marketed ⓘ

Also listed with the FDA, not a patient dose form: Powder (12) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

Msn Laboratories Private Limited8%
Genzyme Corporation6%
Zydus Lifesciences Limited5%
Aurobindo Pharma Limited5%
Zydus Pharmaceuticals USA Inc.4%
Accord Healthcare Inc.4%
Other makers67%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

📈 How widely Teriflunomide is used

A general measure of how commonly Teriflunomide is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Teriflunomide is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

8,104
Medicaid prescriptions filled (Q1–Q4 2025)
$12.8M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Teriflunomide prescribed? Of the 1,596 medications we measure, Teriflunomide ranks #967 by Medicaid prescriptions — more than 39% of them.

Where Teriflunomide ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5
Total prescriptions — #967 of 1,596
#962 Atezolizumab Injection 8,313 Rx #963 Niacin 8,285 Rx #964 Flunisolide Nasal Spra... 8,259 Rx #965 Varenicline Nasal Spra... 8,153 Rx #966 IncobotulinumtoxinA In... 8,147 Rx #967 Teriflunomide 8,104 Rx #968 Darolutamide 8,087 Rx #969 Aspirin, Butalbital, a... 8,077 Rx #970 Pemetrexed Injection 8,046 Rx #971 Treprostinil Injection 7,921 Rx #972 Nicotine Nasal Spray 7,853 Rx

Utilization by Teriflunomide product

Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

The 14 mg oral tablet is the most-dispensed Teriflunomide product — about 93% of these Medicaid prescriptions.

teriflunomide 14 MG Oral Tablet Most dispensed

7,571 Medicaid prescriptions (Q1–Q4 2025) 93% of Teriflunomide prescriptions shown $12.3M gross reimbursement (before rebates) ≈ $1,629 per prescription (gross)

Summed across the 6 of 50 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1310525

teriflunomide 7 MG Oral Tablet

533 Medicaid prescriptions (Q1–Q4 2025) 7% of Teriflunomide prescriptions shown $442,561 gross reimbursement (before rebates) ≈ $830 per prescription (gross)

Summed across the 4 of 48 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1310533

Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Teriflunomide, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 10 of 98 listed Teriflunomide NDCs with Medicaid activity.

🔍 Compare Teriflunomide products

A representative set of FDA-listed product records for Teriflunomide — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Showing 93 of 93 products — FDA National Drug Code Directory. See every product, package size and price: browse all 93 Teriflunomide NDCs →

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

Ingredient (IN) Teriflunomide RxCUI 1310520 1 dose form · 2 strengths
  1. Dose form (SCDF) Oral Tablet RxCUI 1310524 In current FDA listings
    Clinical drug / strength (SCD) 7 MG RxCUI 1310533 14 MG RxCUI 1310525

Look up RxCUI 1310520 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

🏷️ Sold under these brand names

Aubagio

🏭 Manufacturers & labelers

Msn Laboratories Private Limited 7 Genzyme Corporation 6 Zydus Lifesciences Limited 5 Aurobindo Pharma Limited 5 Zydus Pharmaceuticals USA Inc. 4 Accord Healthcare Inc. 4 Teva Pharmaceuticals, Inc. 4 Opella Healthcare International Sas 4 Glenmark Pharmaceuticals Inc., USA 4 Concord Biotech Limited 4 Biocon Pharma Inc. 4 Alembic Pharmaceuticals Inc. 4 AvKARE 4 Amneal Pharmaceuticals NY LLC 4 Mylan Pharmaceuticals Inc. 2 Aizant Drug Research Solutions Pvt Ltd 2 Alembic Pharmaceuticals Limited 2 SOLA Pharmaceuticals, LLC 2 Sandoz Inc 2 Natco Pharma USA LLC 2 Apotex Corp 2 Dr. Reddy's Laboratories Inc 2 Camber Pharmaceuticals, Inc. 2 Breckenridge Pharmaceutical, Inc. 2

…and 10 more on the FDA NDC directory.

RxNorm drug class

Teriflunomide belongs to the Pyrimidine Synthesis Inhibitor class.

Pharmacologic class Pyrimidine Synthesis Inhibitor
Drug family (ATC) Dihydroorotate dehydrogenase (DHODH) inhibitors
How it works Dihydroorotate Dehydrogenase Inhibitors

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

🔬 Where this comes from

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Feb 20, 2026
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Teriflunomide.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Teriflunomide after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
16
NDC products indexed
93
Distinct labelers/manufacturers represented
34
Linked representative label ⓘ
Genzyme Corporation
Linked label effective
Feb 20, 2026
Composite sections available
25
Linked SPL Set ID
4650d12c-b9c8-4525-b07f-a2d773eca155
Linked SPL Document ID
fafc0928-a014-4dfc-8f46-e0d8aa6690bc
Open the linked representative label on DailyMed ↗

How we combine label and product data

HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 16 FDA-filed SPL label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.

For canonical ingredient pages, bounded product-attributed indication and administration excerpts may be added to the AI evidence, and the generator is instructed to preserve available product, brand, route, and form qualifiers instead of treating one label as universal. Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Genzyme Corporation is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.

This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.