Last update June 9, 2026

Mycophenolate Mofetil Hydrochloride

Likely Compatibility

Fairly safe. Mild or unlikely adverse effects. Compatible under certain circumstances. Follow-up recommended. Read Commentary.

Immunosuppressant indicated in the prophylaxis of acute renal, cardiac or liver allogeneic transplant rejection. Oral administration twice a day.

There are discrepancies between two studies that measured the excretion of the drug in breast milk: in one (Huerta 2021), excretion is high, with a relative dose (RD) of 19% or higher, whilst in the other (Krutsch 2023), excretion was negligible: RD 0.02%. 

Its pharmacokinetic data (large volume of distribution and high percentage of protein binding) makes transfer into breastmilk in significant quantities unlikely.

No problems have been observed in infants breastfed for up to 14 months whose mothers were taking it. (Boyle 2021, Constantinescu 2014)

Its use is authorized in infants from 3 months of age (FDA 2018). Mycophenolate is considered unsafe during lactation by various medical societies and expert consensus. (Hale, Rüegg 2025, Pluma 2025, Birru 2020, Brown 2017, Flint 2016, Shah 2016, Götestam 2016, Noviani 2016, Briggs 2015, Butler 2014, Weber 2008, Mahadevan 2006, Østensen 2006, Temprano 2005)

Until there is more published data on this drug in relation to breastfeeding, safer known alternatives are preferable (Shah 2016), especially during the neonatal period and in cases of prematurity.


See below the information of this related product:

  • Maternal Transplant (Fairly safe. Mild or unlikely adverse effects. Compatible under certain circumstances. Follow-up recommended. Read Commentary.)

Alternatives

Suggestions made at e-lactancia are done by APILAM team of health professionals, and are based on updated scientific publications. It is not intended to replace the relationship you have with your doctor but to compound it. The pharmaceutical industry contraindicates breastfeeding, mistakenly and without scientific reasons, in most of the drug data sheets.

Jose Maria Paricio, Founder & President of APILAM/e-Lactancia

Your contribution is essential for this service to continue to exist. We need the generosity of people like you who believe in the benefits of breastfeeding.

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José María Paricio, founder of e-lactancia.
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Other names

Mycophenolate Mofetil Hydrochloride is also known as Mycophenolate Mofetil. Here it is a list of alternative known names::


Mycophenolate Mofetil Hydrochloride in other languages or writings:

Groups

Mycophenolate Mofetil Hydrochloride belongs to these groups or families:

Tradenames

Main tradenames from several countries containing Mycophenolate Mofetil Hydrochloride in its composition:

Pharmacokinetics

Variable Value Unit
Oral Bioavail. 94 %
Molecular weight 434 daltons
Protein Binding 97 %
VD 3.6 ± 1.5 l/Kg
pKa 9.76 -
Tmax 1 - 1.5 hours
T½ 17. 9 ± 6.5 hours
Theoretical Dose 0.06 - 1.2 (?) mg/Kg/d
Relative Dose 0.02 - 19. (?) %

References

  1. Hale TW. Medications & Mothers' Milk. 1991- . Springer Publishing Company. Available from https://www.halesmeds.com Consulted on April 10, 2024 Full text (link to original source)
  2. Rüegg L, Pluma A, Hamroun S, Cecchi I, Perez-Garcia LF, Anderson PO, Andreoli L, Wirström SB, Boyadhzieva V, Chambers C, Costedoat-Chalumeau N, Dolhain RJEM, Fischer-Betz R, Giles I, Gøtestam-Skorpen C, Hoeltzenbein M, Marchiori F, Mayer-Pickel K, Molto A, Nelson-Piercy C, Nielsen OH, Tincani A, et al. EULAR recommendations for use of antirheumatic drugs in reproduction, pregnancy, and lactation: 2024 update. Ann Rheum Dis. 2025 Jun;84(6):910-926. Abstract Full text (link to original source)
  3. Pluma A, Hamroun S, Rüegg L, Cecchi I, Kramer M, Perez-Garcia LF, Rivero T, Finckh A, Meissner Y, Förger F. Antirheumatic drugs in reproduction, pregnancy, and lactation: a systematic literature review informing the 2024 update of the EULAR recommendations. Ann Rheum Dis. 2025 Sep;84(9):1561-1590. Abstract Full text (link to original source)
  4. Krutsch K, Burkham J, Datta P, Hale TW. Transfer of mycophenolic acid into human milk. J Nephrol. 2023 Jul;36(6):1715-1717. Abstract
  5. Huerta A, Caballero Bermejo AF, de Villa LF, Sedano R, Ruiz-Antorán B, Avendaño-Solá C, Portoles Pérez J, Sancho-López A. Measurement of the passage of mycophenolic acid into breast milk in a patient with lupus nephritis. Kidney Int. 2021 Sep;100(3):711. Abstract Full text (link to original source)
  6. Boyle S, Sung-Him Mew T, Lust K, McKenzie S, Javorsky G, Parsonage W. Pregnancy Following Heart Transplantation: A Single Centre Case Series and Review of the Literature. Heart Lung Circ. 2021 Jan;30(1):144-153. Abstract
  7. Birru Talabi M, Clowse MEB. Antirheumatic medications in pregnancy and breastfeeding. Curr Opin Rheumatol. 2020 May;32(3):238-246. Abstract
  8. FDA. Mycophenolate. Drug summary. 2018 Full text (in our servers)
  9. Brown SM, Aljefri KA, Waas R, Hampton PJ. Systemic medications used in treatment of common dermatological conditions: Safety profile with respect to pregnancy, breast feeding and content in seminal fluid. J Dermatolog Treat. 2017 Abstract
  10. Götestam Skorpen C, Hoeltzenbein M, Tincani A, Fischer-Betz R, Elefant E, Chambers C, da Silva J, Nelson-Piercy C, Cetin I, Costedoat-Chalumeau N, Dolhain R, Förger F, Khamashta M, Ruiz-Irastorza G, Zink A, Vencovsky J, Cutolo M, Caeyers N, Zumbühl C, Østensen M. The EULAR points to consider for use of antirheumatic drugs before pregnancy, and during pregnancy and lactation. Ann Rheum Dis. 2016 May;75(5):795-810. Abstract Full text (link to original source) Full text (in our servers)
  11. Noviani M, Wasserman S, Clowse ME. Breastfeeding in mothers with systemic lupus erythematosus. Lupus. 2016 Aug;25(9):973-9. Abstract
  12. Flint J, Panchal S, Hurrell A, van de Venne M, Gayed M, Schreiber K, Arthanari S, Cunningham J, Flanders L, Moore L, Crossley A, Purushotham N, Desai A, Piper M, Nisar M, Khamashta M, Williams D, Gordon C, Giles I; BSR and BHPR Standards, Guidelines and Audit Working Group. BSR and BHPR guideline on prescribing drugs in pregnancy and breastfeeding-Part I: standard and biologic disease modifying anti-rheumatic drugs and corticosteroids. Rheumatology (Oxford). 2016 Sep;55(9):1693-7. Abstract Full text (link to original source) Full text (in our servers)
  13. Shah S, Verma P. Overview of Pregnancy in Renal Transplant Patients. Int J Nephrol. 2016;2016:4539342. Abstract
  14. Briggs GG, Freeman RK, Towers CV, Forinash AB. Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk. Wolters Kluwer Health. Tenth edition (acces on line) 2015
  15. Constantinescu S, Pai A, Coscia LA, Davison JM, Moritz MJ, Armenti VT. Breast-feeding after transplantation. Best Pract Res Clin Obstet Gynaecol. 2014 Nov;28(8):1163-73. Abstract
  16. Butler DC, Heller MM, Murase JE. Safety of dermatologic medications in pregnancy and lactation: Part II. Lactation. J Am Acad Dermatol. 2014 Mar;70(3):417.e1-10; quiz 427. Abstract
  17. Weber JC, Kuhnert C. Traitements de fond des affections inflammatoires systémiques au cours de l’allaitement. [Breastfeeding and drug management in connective tissue and rheumatic diseases]. Rev Med Interne. 2008 Dec;29(12):1017-23. Abstract
  18. AEMPS. Micofenolato. Ficha técnica. 2006 Full text (in our servers)
  19. Østensen M, Khamashta M, Lockshin M, Parke A, Brucato A, Carp H, Doria A, Rai R, Meroni P, Cetin I, Derksen R, Branch W, Motta M, Gordon C, Ruiz-Irastorza G, Spinillo A, Friedman D, Cimaz R, Czeizel A, Piette JC, Cervera R, Levy RA, et al. Anti-inflammatory and immunosuppressive drugs and reproduction. Arthritis Res Ther. 2006 Abstract Full text (link to original source) Full text (in our servers)
  20. Mahadevan U, Kane S. American gastroenterological association institute technical review on the use of gastrointestinal medications in pregnancy. Gastroenterology. 2006 Jul;131(1):283-311. Review. Abstract Full text (link to original source) Full text (in our servers)
  21. Temprano KK, Bandlamudi R, Moore TL. Antirheumatic drugs in pregnancy and lactation. Semin Arthritis Rheum. 2005 Abstract

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