Two medicines, side by side
Abatacept vs leflunomide
Abatacept and leflunomide are both labeled for rheumatoid arthritis. Drugs@FDA records approvals of abatacept since 2005 and of leflunomide since 1998. Pharmacies paid $1,469.23 per mL (Orencia 125 mg/mL syringe) and $0.324 per leflunomide 10 mg tablet (NADAC, October 7, 2026); the strengths differ and one is a brand and one a generic, so the two prices are not like for like. In FDA's classes, abatacept is a selective t cell costimulation modulator and leflunomide an antirheumatic agent.
Check it at the source: the abatacept FDA label on DailyMed (effective November 13, 2025); the leflunomide FDA label on DailyMed (effective June 4, 2025).
Highlights of the abatacept record
Abatacept (Orencia) · label of November 13, 2025
Used for
From the label: indicationsORENCIA is a selective T cell costimulation modulator indicated for: • the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA). (1.1) • the treatment of patients 2 years of age and older with moderately to severely active polyarticular juvenile idiopathic arthritis (pJIA). (1.2) • the treatment of patients 2 years of age and older with active psoriatic arthritis (PsA). […]
On the market
- Earliest approval on file
- December 23, 2005
- Generic labelers
- none listed
- Pharmacy cost
- $1,469.23 per mL
Supply and safety
- Shortage
- No current entry
- Recalls
- 0
Highlights of the leflunomide record
Leflunomide (Arava) · label of June 4, 2025
EMBRYO-FETAL TOXICITY and HEPATOTOXICITY WARNING: EMBRYO-FETAL TOXICITY and HEPATOTOXICITY See full prescribing information for complete boxed warning. Embryo-Fetal Toxicity Teratogenicity and embryo-lethality occurred in animals administered leflunomide. ( 5.1 , 8.1 ) Exclude pregnancy prior to initiating ARAVA therapy. ( 5.1 , 8.3 ) Advise use of effective contraception in females of reproductive potential during treatment and during a drug elimination procedure.
Used for
From the label: indicationsARAVA is indicated for the treatment of adults with active rheumatoid arthritis (RA). ARAVA is a pyrimidine synthesis inhibitor indicated for the treatment of adults with active rheumatoid arthritis.
On the market
- Earliest approval on file
- September 10, 1998
- Generic labelers
- 16 labelers
- Pharmacy cost
- $0.324 per tablet
Supply and safety
- Shortage
- A presentation being discontinued
- Recalls
- 2
Source: FDA drug labels via openFDA (Abatacept label of November 13, 2025, Leflunomide label of June 4, 2025); NDC Directory, Drugs@FDA, NADAC, FDA shortages and recalls (October 8, 2026)
How do abatacept and leflunomide differ on the record?
In FDA's classes, abatacept is a selective t cell costimulation modulator and leflunomide an antirheumatic agent.
How each works, in its label's words: Abatacept, “Abatacept, a selective costimulation modulator, inhibits T-cell (T lymphocyte) activation by binding to CD80 and CD86, thereby blocking interaction with CD28.”; Leflunomide, “Leflunomide is an isoxazole immunomodulatory agent that inhibits dihydroorotate dehydrogenase (a mitochondrial enzyme involved in de novo pyrimidine synthesis) and has antiproliferative activity.”
Half-life, in each label's words: Abatacept, “Mean estimates for systemic clearance (0.28 mL/h/kg), volume of distribution (0.11 L/kg), and terminal half-life (14.3 …”; Leflunomide, “Due to the very long half-life of teriflunomide (18–19 days), a loading dose of 100 mg for 3 days was used in clinical …”
Only the leflunomide label carries a boxed warning.
Generics: abatacept none approved; leflunomide since 2005 (Drugs@FDA).
| Abatacept | Leflunomide | |
|---|---|---|
| Labeled for | Rheumatoid arthritis | Rheumatoid arthritis |
| Pharmacologic class | Selective T Cell Costimulation Modulator | Antirheumatic Agent |
| How it works (label) | Abatacept, a selective costimulation modulator, inhibits T-cell (T lymphocyte) activation by binding to CD80 and CD86, thereby blocking interaction with CD28. | Leflunomide is an isoxazole immunomodulatory agent that inhibits dihydroorotate dehydrogenase (a mitochondrial enzyme involved in de novo pyrimidine synthesis) and has antiproliferative activity. |
| Half-life (label) | Mean estimates for systemic clearance (0.28 mL/h/kg), volume of distribution (0.11 L/kg), and terminal half-life (14.3 days) were comparable between subcutaneous and intravenous administration. | Due to the very long half-life of teriflunomide (18–19 days), a loading dose of 100 mg for 3 days was used in clinical studies to facilitate the rapid attainment of steady-state teriflunomide concentrations. |
| Earliest approval on file (Drugs@FDA) | December 23, 2005 | September 10, 1998 |
| First generic approved | none | September 13, 2005 |
| Generic labelers (NDC) | none listed | 16 labelers |
| Pharmacy cost (NADAC, each one's most listed form; strengths differ) | $1,469.23 per mL (Orencia 125 mg/mL syringe) | $0.324 per tablet (Leflunomide 10 mg tablet) |
| 12-month price change | +2% | -7% |
| Boxed warning | No | Yes |
| Shortage now | No current entry | A presentation being discontinued |
| Recalls recorded | 0 | 2 |
| FAERS reports (a report is not proof of cause; counts follow how widely a medicine is used) | 137,678 | 104,036 |
| DEA schedule | none | none |
Source: Drugs@FDA, FDA NDC Directory, CMS NADAC of October 7, 2026, FDA shortages and recalls, FAERS via openFDA (FDA files October 8, 2026)
What next?
- Alternatives to abatacept
- every medicine labeled for the same conditions