Mycophenolate Mofetil
Active ingredient
Sold as Myfenax · Myclausen · CELLCEPT · AG-MYCOPHENOLATE · APO-MYCOPHENOLATE
- Drug class
- -
- Availability
- Prescription only
- Routes
- Oral, Intravenous
- Markets covered
- 4
- Products on record
- 72
- FDA reports (12 mo)
- 12,347
Overview
Plain-language summary, compiled from the cited regulatory records
Mycophenolate mofetil is an antimetabolite immunosuppressant [1]. It is indicated for the prevention of organ rejection in adult and pediatric recipients aged 3 months and older who have undergone allogeneic kidney, heart, or liver transplants [1]. It is used in combination with other immunosuppressants [1].
Mycophenolate mofetil is available under several brand names [1]. In the past 12 months, there have been 12,347 adverse event reports associated with this active ingredient [2]. The most frequently reported adverse events include off-label use, drug ineffectiveness, diarrhea, condition aggravation, and infection [2].
This is not medical advice. Consult a qualified healthcare professional.
Regulatory status by market
| Market | Regulator | Products | Last revision |
|---|---|---|---|
| GB United Kingdom | MHRA | 44 | May 29, 2026 |
| CA Canada | Health Canada | 20 | May 21, 2026 |
| US United States | FDA | 4 | May 14, 2026 |
| EU European Union | EMA | 4 | May 7, 2026 |
GBUnited Kingdom· MHRA
44 products
Uses
Mycophenolate mofetil is indicated in combination with ciclosporin and corticosteroids for the prophylaxis of acute transplant rejection in patients receiving allogeneic renal, cardiac or hepatic transplants.
How to take
CACanada· Health Canada
20 products
Uses
TEVA-MYCOPHENOLATE (mycophenolate mofetil) is indicated for:
Adults • The prophylaxis of organ rejection in patients receiving allogeneic renal, cardiac or hepatic transplants. TEVA-MYCOPHENOLATE should be used concomitantly with cyclosporine and corticosteroids. 1 Pediatrics (2-18 years of age) • TEVA-MYCOPHENOLATE is indicated for the prophylaxis of organ rejection in pediatric patients (2 to 18 years) receiving allogeneic renal transplants.
TEVA-MYCOPHENOLATE should be used concomitantly with cyclosporine and corticosteroids. 2 Geriatrics • No data are available to Health Canada; therefore, Health Canada has not authorized an indication for geriatric use.
How to take
USUnited States· FDA
4 products
Uses
3) ], in combination with other immunosuppressants. Mycophenolate mofetil is an antimetabolite immunosuppressant indicated for the prophylaxis of organ rejection in adult and pediatric recipients 3 months of age and older of allogeneic kidney, heart or liver transplants, in combination with other immunosuppressants ( 1 )
How to take
EUEuropean Union· EMA
4 products
Uses
CellCept is indicated in combination with ciclosporin and corticosteroids for the prophylaxis of acute transplant rejection in adult and paediatric (1 to 18 years of age) patients receiving allogeneic renal, cardiac or hepatic transplants.
How to take
Drug interactions
Known interactions involving Mycophenolate Mofetil. Select one for details. This list is informational and not a complete interaction checker.
Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.
Sources & citations
- [1]MHRA (UK) · PL044160712 · revised June 6, 2025
- [2]Health Canada (DPD) · 02348675 · revised October 9, 2025
- [3]FDA DailyMed · 0f1704e2-a66a-4b… · revised May 14, 2026 [PDF]
- [4]European Medicines Agency · EMEA/H/C/000082 · revised May 7, 2026
- [5]OpenFDA adverse-event reports (US), 12 months ending June 4, 2026.
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.