ACCEL-LEFLUNOMIDE
As listed in the register: ACCEL-LEFLUNOMIDE
10 mg · tablet
- Prescription only
- Cancer treatments and immune-system medicines
- Active substance
- Leflunomide
- Made by
- Accel Pharma Inc
- Source
- Official label
Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.
What it is for
Mediclarum has not yet retrieved and stored the official label for this product, so none of its text is shown here. Open the official leaflet
How it works
From the US prescribing label for the same active substance (Leflunomide). It describes the substance, not this exact product.
Leflunomide is an isoxazole immunomodulatory agent that inhibits dihydroorotate dehydrogenase (a mitochondrial enzyme involved in de novo pyrimidine synthesis) and has antiproliferative activity.
Several in vivo and in vitro experimental models have demonstrated an anti-inflammatory effect.
Following oral administration, leflunomide is metabolized to an active metabolite, teriflunomide, which is responsible for essentially all of leflunomide's in vivo activity.
Teriflunomide, the active metabolite of leflunomide, is eliminated by direct biliary excretion of unchanged drug as well as renal excretion of metabolites.
Effect of food Coadministration of leflunomide tablets with a high fat meal did not have a significant impact on teriflunomide plasma concentrations.
Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2026-05-01
Safety of the active substance
From the US prescribing label for the same active substance (Leflunomide). It describes the substance, not this exact product.
WARNING: EMBRYO-FETAL TOXICITY and HEPATOTOXICITY WARNING: EMBRYO-FETAL TOXICITY and HEPATOTOXICITY See full prescribing information for complete boxed warning.
- Leflunomide is contraindicated in: Pregnant women.
- Leflunomide may cause fetal harm.
- If a woman becomes pregnant while taking this drug, stop leflunomide, apprise the patient of the potential hazard to the fetus, and begin a drug elimination procedure [see Warnings and Precautions (5.1, 5.3) and Use in Specific Populations (8.1) ].
- Patients with severe hepatic impairment [see Warnings and Precautions (5.2) ].
Most Common Adverse Reactions The most common adverse reactions in leflunomide-treated patients with RA include diarrhea, elevated liver enzymes (ALT and AST), alopecia, and rash.
Quoted from the US prescribing label for the same active substance. Your own pack’s leaflet is the authority for your product. DailyMed
Same active substance, strength and form in other countries
Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.
Medicine passport: one printable page to show a pharmacist abroad
United States17 matching products
European UnionNo exact match for this strength and form
Spain14 matching products
- ARAVA 10 mg · comprimido recubierto con película2 makers
- LEFLUNOMIDA MEDAC 10 mg · comprimido recubierto con película2 makers
- LEFLUARTIL 10 MG · comprimido recubierto con película
- LEFLUNOMIDA AUROVITAS 10 mg · comprimido recubierto con película
- LEFLUNOMIDA CINFA 10 mg · comprimido recubierto con película
- LEFLUNOMIDA NORMON 10 mg · comprimido recubierto con película
- LEFLUNOMIDA PHARMATHEN 10 mg · comprimido recubierto con película
- LEFLUNOMIDA RATIOPHARM 10 mg leflunomida · comprimido recubierto con película
Netherlands9 matching products
- Arava 10 mg 10 mg · filmomhulde tablet
- Leflunomide Aurobindo 10 mg 10 mg · filmomhulde tablet
- Leflunomide CF 10 mg 10 mg · filmomhulde tablet
- Leflunomide medac 10 mg 10 mg · filmomhulde tablet
- Leflunomide ratiopharm 10 mg 10 mg · filmomhulde tablet
- Leflunomide Sandoz 10 mg 10 mg · filmomhulde tablet
- Leflunomide Tillomed 10 mg 10 mg · tablet
- Leflunomide Viatris 10 mg 10 mg · filmomhulde tablet
SwitzerlandNo exact match for this strength and form
Details
| Made by | Accel Pharma Inc |
|---|---|
| Active substance | Leflunomide |
| Used in | Cancer treatments and immune-system medicines |
| Strength | 10 mg |
| Form | tablet |
| Classification | L04AK01 · Cancer treatments and immune-system medicines |
| Route | oral |
| Dispensing (as stated by the register) | PRESCRIPTION |
| Status | Marketed |
| Marketed | Yes, according to the register |
| DIN | 02478862 |
| DPD drug code | 96957 |
Source: Drug Product Database · 2026-09-30 · not reviewed by a clinician
Contains information licensed under the Open Government Licence – Canada. Reuse terms: Open Government Licence – Canada.
Other strengths and forms
2 products are sold under this name. Grouped by form; a number on a strength means several companies make it.
- tablet2 products
- 10 mg
- 20 mg
Same active substance
These contain the same substance. That does not mean one can replace another — ask a pharmacist.