Last update Jan. 15, 2026

FR-900506

Compatible

Safe product and/or breastfeeding is the best option.

Immunosuppressive macrolide that inhibits calcineurin, used to prevent transplant rejection (kidney, liver, heart, etc.) and in the treatment of atopic eczema, psoriasis and other autoimmune diseases (arthritis, lupus, inflammatory bowel disease, etc.). Oral systemic and topical dermatological administration.

Its high molecular weight and high protein binding explain the clinically insignificant excretion obtained in colostrum and breast milk. (Kuczaj 2024, Akamine 2021, Hiramatsu 2018, Kociszewska 2018, Zheng 2013, Bramham 2013, Gardiner 2006, French 2003, Jain 1997)

No short- or long-term developmental or immunological problems have been observed in more than 200 infants whose mothers took it (Coscia 2025, Deans 2025, Kuczaj 2024, Mizutani 2023, Boyle 2021, Klintmalm 2020, Nure 2019, Constantinescu 2014, Izumi 2014, Thiagarajan 2013, Gouraud 2012, French 2003), except for one mild, self-resolving case of transient thrombocytosis. (Gouraud 2012)

Plasma levels in these infants were undetectable or very low. (Kuczaj 2024, Akamine 2021, Hiramatsu 2018, Izumi 2014 Bramham 2013, Gomez-Lobo 2012, Gouraud 2012)

Its low oral bioavailability, which is further reduced when taken with food (EMA 2015), especially if it is fatty, hinders its passage into the infant's plasma from the breast milk ingested.

Infants who have been exposed to calcineurin inhibitors during pregnancy may have immune deficiency in the first year of life (Grimer 2007), hence the importance of not being deprived of breastfeeding without a proven reason.

Tacrolimus may cause a slight decrease in serum prolactin levels, which has no impact on breast milk production in established breastfeeding. (Szypulska 2021)

Various medical societies and expert consensus groups consider the use of tacrolimus during breastfeeding to be safe. (Rüegg 2024, Russell 2023, Sammaritano 2020, Götestam-Skorpen 2016, Flint 2016, Durst 2015, Constantinescu 2014, Schulze 2014, Thiagarajan 2013, Armenti 2013, van der Houde 2010, Østensen 2006)


See below the information of this related product:

Alternatives

We do not have alternatives for FR-900506 since it is relatively safe.

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

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

FR-900506 is Tacrolimus (oral use) in Experimental code/s.

Is written in other languages:

Groups

FR-900506 belongs to these groups or families:

Tradenames

Main tradenames from several countries containing FR-900506 in its composition:

Pharmacokinetics

Variable Value Unit
Oral Bioavail. 20 - 25 %
Molecular weight 822 daltons
Protein Binding 99 %
VD 2.6 l/Kg
Tmax 1.6 - 3 hours
T½ 34 - 43 hours
M/P ratio 0.5 -
Theoretical Dose 0.00006 mg/Kg/d
Relative Dose 0.06 - 0.5 %
Ped.Relat.Dose 0.03 - 0.2 %

References

  1. 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)
  2. Coscia LA, Kliniewski D, Rao S, et al. Breastfeeding after transplantation: 25 year review (1999-2024). Am J Transplant 2025;25:S772. Full text (link to original source)
  3. Deans R, Gerstl B, Shand AW, Lyons S, Budden A, Barrett HL, Luxton G, Fernando M, Yong K, Keung K, Arulpragasam K, Pleass H, Wan KM, Kehag E, Pittman JE, Lotz M, Fenn M, Nesbitt-Hawes E, Byun L, Tang K, Brannstrom M, Abbott J. The first live term birth following uterus transplantation in Australia. Med J Aust. 2025 Oct 20;223(8):404-409. Abstract Full text (link to original source)
  4. Kuczaj A, Danel A, Warwas S, Przybyłowski P, Śliwka J, Pawlak S, Trzcińska I, Hrapkowicz T. Toxic milk- should we still be afraid of breastfeeding while on tacrolimus therapy: A case study. J Heart Lung Transplant 2024;43:S631. Full text (link to original source)
  5. Russell MD, Dey M, Flint J, Davie P, Allen A, Crossley A, Frishman M, Gayed M, Hodson K, Khamashta M, Moore L, Panchal S, Piper M, Reid C, Saxby K, Schreiber K, Senvar N, Tosounidou S, van de Venne M, Warburton L, Williams D, Yee CS, et al. British Society for Rheumatology guideline on prescribing drugs in pregnancy and breastfeeding: immunomodulatory anti-rheumatic drugs and corticosteroids. Rheumatology (Oxford). 2023 Apr 3;62(4):e48-e88. Abstract Full text (link to original source)
  6. Mizutani S, Okunishi Y, Tamada T, Tanaka H, Ito Y, Yamamoto Y, Kitamura A, Tanaka H, Ikeda T, Nakajima A. A Woman with Rheumatoid Arthritis Who Successfully Delivered a Healthy Child with Continuous Administration of Sarilumab Throughout Pregnancy. Intern Med. 2023 Feb 15;62(4):633-636. Abstract Full text (link to original source)
  7. Akamine Y, Fujiyama N, Kagaya H, Saito M, Miura H, Terada Y, Takahashi T, Satoh S, Miura M. Tacrolimus concentrations after renal transplantation in a mother-neonate dyad: Maternal, neonatal and breast milk measurements. J Clin Pharm Ther. 2021 Dec;46(6):1800-1803. Abstract
  8. Szypulska-Koziarska D, Wilk A, Marchelek-Myśliwiec M, Śleboda-Taront D, Wiszniewska B. Tacrolimus-Based Immunosuppressive Therapy Influences Sex Hormone Profile in Renal-Transplant Recipients-A Research Study. Biology (Basel). 2021 Jul 24;10(8). Abstract Full text (link to original source)
  9. 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
  10. Klintmalm GB, Gunby RT Jr. Successful Pregnancy in a Liver Transplant Recipient on Belatacept. Liver Transpl. 2020 Sep;26(9):1193-1194. Abstract
  11. Sammaritano LR, Bermas BL, Chakravarty EE, Chambers C, Clowse MEB, Lockshin MD, Marder W, Guyatt G, Branch DW, Buyon J, Christopher-Stine L, Crow-Hercher R, Cush J, Druzin M, Kavanaugh A, Laskin CA, Plante L, Salmon J, Simard J, Somers EC, Steen V, Tedeschi SK, et al. 2020 American College of Rheumatology Guideline for the Management of Reproductive Health in Rheumatic and Musculoskeletal Diseases. Arthritis Rheumatol. 2020 Apr;72(4):529-556. Abstract Full text (link to original source)
  12. Nure E, Pascale MM, Frongillo F, Franco A, Bianco G, Agnes S. Pregnancy After Liver Transplant: Neonatal Outcomes and Long-Term Maternal Follow-up. Transplant Proc. 2019 Nov;51(9):2948-2951. Abstract
  13. Kociszewska-Najman B, Mazanowska N, Pietrzak B, Paczek L, Szpotanska-Sikorska M, Schreiber-Zamora J, Hryniewiecka E, Zochowska D, Samborowska E, Dadlez M, Wielgos M. Low Transfer of Tacrolimus and Its Metabolites into Colostrum of Graft Recipient Mothers. Nutrients. 2018 Abstract Full text (link to original source) Full text (in our servers)
  14. Hiramatsu Y, Yoshida S, Kotani T, Nakamura E, Kimura Y, Fujita D, Nagayasu Y, Shabana K, Makino S, Takeuchi T, Arawaka S. Changes in the blood level, efficacy, and safety of tacrolimus in pregnancy and the lactation period in patients with systemic lupus erythematosus. Lupus. 2018 Dec;27(14):2245-2252. Abstract
  15. Levy RA, de Jesús GR, de Jesús NR, Klumb EM. Critical review of the current recommendations for the treatment of systemic inflammatory rheumatic diseases during pregnancy and lactation. Autoimmun Rev. 2016 Abstract
  16. Shah S, Verma P. Overview of Pregnancy in Renal Transplant Patients. Int J Nephrol. 2016;2016:4539342. Abstract
  17. 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)
  18. 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)
  19. EMA. Tacrolimus. Drug Summary. 2015 Full text (in our servers)
  20. EMA. Tacrolimus. Ficha técnica. 2015 Full text (in our servers)
  21. van der Woude CJ, Ardizzone S, Bengtson MB, Fiorino G, Fraser G, Katsanos K, Kolacek S, Juillerat P, Mulders AG, Pedersen N, Selinger C, Sebastian S, Sturm A, Zelinkova Z, Magro F; European Crohn’s and Colitis Organization. The second European evidenced-based consensus on reproduction and pregnancy in inflammatory bowel disease. J Crohns Colitis. 2015 Feb;9(2):107-24. Review. Abstract Full text (link to original source) Full text (in our servers)
  22. Durst JK, Rampersad RM. Pregnancy in Women With Solid-Organ Transplants: A Review. Obstet Gynecol Surv. 2015 Abstract
  23. Schulze H, Esters P, Dignass A. Review article: the management of Crohn's disease and ulcerative colitis during pregnancy and lactation. Aliment Pharmacol Ther. 2014 Nov;40(9):991-1008. Abstract Full text (link to original source) Full text (in our servers)
  24. 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
  25. López LF, Martínez CJ, Castañeda DA, Hernández AC, Pérez HC, Lozano E. Pregnancy and kidney transplantation, triple hazard? Current concepts and algorithm for approach of preconception and perinatal care of the patient with kidney transplantation. Transplant Proc. 2014 Abstract
  26. Izumi Y, Miyashita T, Migita K. Safety of tacrolimus treatment during pregnancy and lactation in systemic lupus erythematosus: a report of two patients. Tohoku J Exp Med. 2014 Sep;234(1):51-6. Abstract Full text (link to original source) Full text (in our servers)
  27. Bramham K, Chusney G, Lee J, Lightstone L, Nelson-Piercy C. Breastfeeding and tacrolimus: serial monitoring in breast-fed and bottle-fed infants. Clin J Am Soc Nephrol. 2013 Abstract
  28. Hebert MF, Zheng S, Hays K, Shen DD, Davis CL, Umans JG, Miodovnik M, Thummel KE, Easterling TR. Interpreting tacrolimus concentrations during pregnancy and postpartum. Transplantation. 2013 Abstract
  29. Thiagarajan KM, Arakali SR, Mealey KJ, Cardonick EH, Gaughan WJ, Davison JM, Moritz MJ, Armenti VT. Safety considerations: breastfeeding after transplant. Prog Transplant. 2013 Jun;23(2):137-46. Abstract
  30. Zheng S, Easterling TR, Hays K, Umans JG, Miodovnik M, Clark S, Calamia JC, Thummel KE, Shen DD, Davis CL, Hebert MF. Tacrolimus placental transfer at delivery and neonatal exposure through breast milk. Br J Clin Pharmacol. 2013 Abstract
  31. Yarur A, Kane SV. Update on pregnancy and breastfeeding in the era of biologics. Dig Liver Dis. 2013 Oct;45(10):787-94. Abstract Full text (link to original source) Full text (in our servers)
  32. Armenti VT, Moritz MJ, Davison JM. Breastfeeding and tacrolimus: is it a reasonable approach? Expert Rev Clin Immunol. 2013 Abstract
  33. Gomez-Lobo V, Landy HJ, Matsumoto C, Fishbein TM. Pregnancy in an intestinal transplant recipient. Obstet Gynecol. 2012 Abstract
  34. Gouraud A, Bernard N, Millaret A, Bruel M, Paret N, Descotes J, Vial T. Follow-up of tacrolimus breastfed babies. Transplantation. 2012 Abstract
  35. Grundmann M, Kacirova I, Duricova J, Perinova I. Metoprolol and alfa-hydroxymetoprolol concentrations during lactation - a case report. 12th International Congress of Therapeutic Drug Monitoring and Clinical Toxicology Stuttgart, Germany · October 2-6, 2011. Poster 088. Ther Drug Monit. 2011;33:504. P088. 2011
  36. van der Woude CJ, Kolacek S, Dotan I, Oresland T, Vermeire S, Munkholm P, Mahadevan U, Mackillop L, Dignass A; European Crohn's Colitis Organisation (ECCO). European evidenced-based consensus on reproduction in inflammatory bowel disease. J Crohns Colitis. 2010 Abstract Full text (link to original source) Full text (in our servers)
  37. 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
  38. Grimer M; Caring for Australians with Renal Impairment (CARI). The CARI guidelines. Calcineurin inhibitors in renal transplantation: pregnancy, lactation and calcineurin inhibitors. Nephrology (Carlton). 2007 Abstract
  39. Heetun ZS, Byrnes C, Neary P, O'Morain C. Review article: Reproduction in the patient with inflammatory bowel disease. Aliment Pharmacol Ther. 2007 Abstract Full text (link to original source) Full text (in our servers)
  40. 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)
  41. Gardiner SJ, Begg EJ. Breastfeeding during tacrolimus therapy. Obstet Gynecol. 2006 Feb;107(2 Pt 2):453-5. Abstract
  42. 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)
  43. French AE, Soldin SJ, Soldin OP, Koren G. Milk transfer and neonatal safety of tacrolimus. Ann Pharmacother. 2003 Abstract Full text (link to original source) Full text (in our servers)
  44. EBPG Expert Group on Renal Transplantation. European best practice guidelines for renal transplantation. Section IV: Long-term management of the transplant recipient. IV.10. Pregnancy in renal transplant recipients. Nephrol Dial Transplant. 2002 Abstract Full text (link to original source) Full text (in our servers)
  45. Anderson PO. Tacrolimus and breastfeeding. Transplantation. 1998 Abstract
  46. Jain A, Venkataramanan R, Fung JJ, Gartner JC, Lever J, Balan V, Warty V, Starzl TE. Pregnancy after liver transplantation under tacrolimus. Transplantation. 1997 Abstract Full text (link to original source) Full text (in our servers)

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