Last update June 9, 2026

Adalimumab

Compatible

Safe product and/or breastfeeding is the best option.

Human IgG1 monoclonal antibody against tumour necrosis factor, used in autoimmune diseases such as rheumatoid arthritis, juvenile idiopathic arthritis, ankylosing spondylitis, psoriatic arthritis, psoriasis, hidradenitis suppurativa, Crohn’s disease, ulcerative colitis and uveitis. Administered subcutaneously on a weekly or fortnightly basis.

It is excreted in breast milk in clinically insignificant amounts (Matro 2018, Fritzsche 2012, Ben-Horin 2010) and no clinical, infectious or developmental problems have been observed in infants whose mothers were taking it. (Palomino 2025, Bendaoud 2024, Membrive 2023, Matro 2018, Lund 2017, Dall'ara 2016, Julsgaard 2013, Fritzsche 2012, Mishkin 2006, Mahadevan 2006, Vesga 2005)

Plasma levels in these infants were undetectable or very low. (Julsgaard 2013, Fritzsche 2012)

Due to its protein nature, it is inactivated in the gastrointestinal tract and is not absorbed (oral bioavailability is practically zero), which hinders or prevents its passage into the infant’s plasma from ingested breast milk (Lactmed, Anderson 2021, Rademaker 2018, Götestam 2016, Witzel 2014, Butler 2014, Mervic 2014), except in preterm infants and during the immediate neonatal period, where there may be increased intestinal permeability (Sammaritano 2020). It may be advisable to avoid its use in the first week after delivery: there may be significant transfer of IgG into milk for the first 3–4 days postpartum. Waiting two weeks after delivery before resuming treatment allows the newborn’s plasma levels to fall from their intrauterine levels and also minimises transmission to the baby. (Krysko 2023) 

A case has been reported of early-onset congenital neutropenia in a newborn whose mother was taking adalimumab for Crohn’s disease and isoniazid for tuberculosis. (van den Broek 2018)

Anti-TNF drugs reduce tumour necrosis factor levels in breast milk (Sepiashvili 2025). This reduction in TNF, which plays a role in milk production, could increase the risk of lactation failure. (Yan 2026)

The manufacturer (Amgen 2017, EMA 2010) considers the use of this medication during breastfeeding to be safe. Numerous experts and scientific societies in the fields of rheumatology, gastroenterology and dermatology consider the risk to be very low and, therefore, its use during breastfeeding to be compatible. (Hale, Mahadevan 2025, Rüegg 2025, Torres 2023, Russell 2023, Owczarek 2020, Yeung 2020, Sammaritano 2020 and 2014, Lamb 2019, Mahadevan 2019 and 2013, Picardo 2019, Amin 2018, Nguyen 2016, Flint 2016, McConnell 2016, Gotestam 2016, Huang 2016 and 2014, Briggs 2015, Grunewald 2015, Damas 2015, van der Woude 2015 and 2010, Nielsen 2014, Witzel 2014, Butler 2014, Schulze 2014, Yarur 2013, Bae 2012, Fischer 2010)


See below the information of these related products:

Alternatives

  • Etanercept (Safe product and/or breastfeeding is the best option.)
  • Infliximab (Safe product and/or breastfeeding is the best option.)

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

Adalimumab in other languages or writings:

Groups

Adalimumab belongs to these groups or families:

Tradenames

Main tradenames from several countries containing Adalimumab in its composition:

Pharmacokinetics

Variable Value Unit
Oral Bioavail. 0 %
Molecular weight 148.000 daltons
Protein Binding 0 %
VD 0.07 - 0.09 l/Kg
Tmax 131 hours
T½ 360 (240 - 480) hours
M/P ratio 0.01 -
Theoretical Dose 0.00465 mg/Kg/d
Relative Dose 0.7 %

References

  1. LactMed. Drugs and Lactation Database (LactMed). Internet. Bethesda (MD): National Library of Medicine (US); 2006-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK501922/ 2006 - Consulted on April 16, 2024 Full text (link to original source)
  2. 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)
  3. Palomino L, Velasco Rodríguez-Belvís M, Casanova MJ, Leo-Carnerero E, Calviño-Suárez C, Rivero M, Calvo M, Arroyo MT, Fernández-Clotet A, Pérez-Martínez I, Masedo González Á, Hernández V, Ruiz-Cerulla A, López Serrano P, Vega P, Rodríguez-Lago I, Lidón RV, De Jorge MÁ, Guerra I, García LA, Molina Arriero G, Hervías Cruz D, et al. Psychomotor Development in Infants Following Maternal Exposure to Biologics: Results From the DUMBO Registry. Clin Gastroenterol Hepatol. 2026 Jun;24(6):1688-1701. Abstract Full text (link to original source)
  4. Yan Z, Chen H, Sun J, Chen T, Zhang W, He Y, He J, Zhang C. Divergent safety profiles of TNF inhibitors in pregnancy: a comprehensive pharmacovigilance analysis of the FAERS database. J Autoimmun. 2026 May;160:103553. Abstract
  5. Sepiashvili L, Brydon A, Koroshegyi C, Gold A, Dalvi P, Ghayoori S, Rahman M, Huang V, Maxwell C, Nguyen GC, Ito S. Reduction of tumor necrosis factor (TNF) in milk of women receiving anti-TNF antibody. Pediatr Res. 2025 May;97(6):1935-1942. Abstract
  6. Hoxha T, Youssef M, Huang V, Tandon P. Inflammatory Bowel Disease and Breastfeeding: A Narrative Review. Inflamm Bowel Dis. 2025 Jan 6;31(1):210-219. Abstract
  7. Mahadevan U, Seow CH, Barnes EL, Chaparro M, Flanagan E, Friedman S, Julsgaard M, Kane S, Ng S, Torres J, Watermeyer G, Yamamoto-Furusho J, Robinson C, Fisher S, Anderson P, Gearry R, Duricova D, Dubinsky M, Long M; Global Consensus Group for Pregnancy and IBD. Global Consensus Statement on the Management of Pregnancy in Inflammatory Bowel Disease. Clin Gastroenterol Hepatol. 2025 Oct;23(11S):S1-S60. Abstract
  8. 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)
  9. Bendaoud S, Nahon S, Beaugerie L, Gornet JM, Wils P, Amiot A, Peyrin-Biroulet L, Abitbol V, Hébuterne X, Altwegg R, Rosa I, Amil M, Heluwaert F, Plastaras L, Stefanescu C, Quentin V, Antoni M, Bideau K, Boualit M, Cuillerier E, Locher C, Skinazi F, et al. Risk of anti-TNF therapy on pregnancy, breastfeeding, live vaccines and related information in patients with inflammatory bowel disease: Real-world data from a nationwide study. Dig Liver Dis. 2024 Dec;56(12):2038-2044. Abstract
  10. 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)
  11. Torres J, Chaparro M, Julsgaard M, Katsanos K, Zelinkova Z, Agrawal M, Ardizzone S, Campmans-Kuijpers M, Dragoni G, Ferrante M, Fiorino G, Flanagan E, Gomes CF, Hart A, Hedin CR, Juillerat P, Mulders A, Myrelid P, O'Toole A, Rivière P, Scharl M, Selinger CP, et al. European Crohn's and Colitis Guidelines on Sexuality, Fertility, Pregnancy, and Lactation. J Crohns Colitis. 2023 Jan 27;17(1):1-27. Abstract Full text (link to original source)
  12. Krysko KM, Dobson R, Alroughani R, Amato MP, Bove R, Ciplea AI, Fragoso Y, Houtchens M, Jokubaitis VG, Magyari M, Abdelnasser A, Padma V, Thiel S, Tintore M, Vukusic S, Hellwig K. Family planning considerations in people with multiple sclerosis. Lancet Neurol. 2023 Apr;22(4):350-366. Abstract
  13. Membrive-Jiménez C, Sánchez-Piedra C, Martínez-González O, García-González J, Expósito-Pérez L, Bohórquez-Heras C, Campos-Fernández C, Sanchez-Alonso F, Cáliz-Cáliz R, Castrejón-Fernández I. Safety and effectiveness of bDMARDs during pregnancy in patients with rheumatic diseases: Real-world data from the BIOBADASER registry. Reumatol Clin (Engl Ed). 2023 Nov;19(9):500-506. Abstract Full text (link to original source)
  14. Stratigakis A, Paty D, Zou P, Zhao Z, Li Y, Zhang T. A regression approach for assessing large molecular drug concentration in breast milk. Reprod Breed 2023;3:199-207. Full text (link to original source) Full text (in our servers)
  15. Anderson PO. Monoclonal Antibodies During Breastfeeding. Breastfeed Med. 2021 Aug;16(8):591-593. Abstract
  16. Owczarek W, Walecka I, Lesiak A, Czajkowski R, Reich A, Zerda I, Narbutt J. The use of biological drugs in psoriasis patients prior to pregnancy, during pregnancy and lactation: a review of current clinical guidelines. Postepy Dermatol Alergol. 2020 Dec;37(6):821-830. Abstract Full text (link to original source)
  17. Yeung J, Gooderham MJ, Grewal P, Hong CH, Lansang P, Papp KA, Poulin Y, Turchin I, Vender R. Management of Plaque Psoriasis With Biologic Therapies in Women of Child-Bearing Potential Consensus Paper. J Cutan Med Surg. 2020 Jul/Aug;24(1_suppl):3S-14S. Abstract
  18. 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)
  19. Lamb CA, Kennedy NA, Raine T, Hendy PA, Smith PJ, Limdi JK, Hayee B, Lomer MCE, Parkes GC, Selinger C, Barrett KJ, Davies RJ, Bennett C, Gittens S, Dunlop MG, Faiz O, Fraser A, Garrick V, Johnston PD, Parkes M, Sanderson J, Terry H; et al. British Society of Gastroenterology consensus guidelines on the management of inflammatory bowel disease in adults. Gut. 2019 Dec;68(Suppl 3):s1-s106. Abstract Full text (link to original source)
  20. Picardo S, Seow CH. A Pharmacological Approach to Managing Inflammatory Bowel Disease During Conception, Pregnancy and Breastfeeding: Biologic and Oral Small Molecule Therapy. Drugs. 2019 Jul;79(10):1053-1063. Abstract
  21. Mugheddu C, Atzori L, Lappi A, Murgia S, Rongioletti F. Biologics exposure during pregnancy and breastfeeding in a psoriasis patient. Dermatol Ther. 2019 May;32(3):e12895. Abstract
  22. Mahadevan U, Robinson C, Bernasko N, Boland B, Chambers C, Dubinsky M, Friedman S, Kane S, Manthey J, Sauberan J, Stone J, Jain R. Inflammatory Bowel Disease in Pregnancy Clinical Care Pathway: A Report From the American Gastroenterological Association IBD Parenthood Project Working Group. Gastroenterology. 2019 Apr;156(5):1508-1524. Abstract Full text (link to original source)
  23. van den Broek L, van der Werff-Ten Bosch J, Cortoos PJ, van Steijn S, van den Akker M. Severe neutropenia in a breastfed infant: a case report and discussion of the differential diagnosis. Int Med Case Rep J. 2018 Nov 15;11:333-337. Abstract
  24. Amin M, No DJ, Egeberg A, Wu JJ. Choosing First-Line Biologic Treatment for Moderate-to-Severe Psoriasis: What Does the Evidence Say? Am J Clin Dermatol. 2018 Feb;19(1):1-13. Abstract
  25. Rademaker M, Agnew K, Andrews M, Armour K, Baker C, Foley P, Frew J, Gebauer K, Gupta M, Kennedy D, Marshman G, Sullivan J. Psoriasis in those planning a family, pregnant or breast-feeding. The Australasian Psoriasis Collaboration. Australas J Dermatol. 2018 May;59(2):86-100. Abstract
  26. Matro R, Martin CF, Wolf D, Shah SA, Mahadevan U. Exposure Concentrations of Infants Breastfed by Women Receiving Biologic Therapies for Inflammatory Bowel Diseases and Effects of Breastfeeding on Infections and Development. Gastroenterology. 2018 Sep;155(3):696-704. Abstract Full text (link to original source) Full text (in our servers)
  27. Lund T, Thomsen SF. Use of TNF-inhibitors and ustekinumab for psoriasis during pregnancy: A patient series. Dermatol Ther. 2017 May;30(3). Abstract
  28. Amgen. Adaiimumab (Amgevita). Ficha técnica. 2017 Full text (in our servers)
  29. 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)
  30. 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
  31. Huang VW, Chang HJ, Kroeker KI, Goodman KJ, Hegadoren KM, Dieleman LA, Fedorak RN. Management of Inflammatory Bowel Disease during Pregnancy and Breastfeeding Varies Widely: A Need for Further Education. Can J Gastroenterol Hepatol. 2016;2016:6193275. Epub 2016 Sep 20. Abstract Full text (link to original source) Full text (in our servers)
  32. Nguyen GC, Seow CH, Maxwell C, Huang V, Leung Y, Jones J, Leontiadis GI, Tse F, Mahadevan U, van der Woude CJ; IBD in Pregnancy Consensus Group. The Toronto Consensus Statements for the Management of Inflammatory Bowel Disease in Pregnancy. Gastroenterology. 2016 Mar;150(3):734-757.e1. Abstract Full text (link to original source) Full text (in our servers)
  33. Dall'ara F, Reggia R, Bazzani C, Andreoli L, Agosti M, Mazza G, Lazzaroni MG, Lojacono A, Motta M, Tincani A. Safety of anti-TNF alfa agents during pregancy and breastfeeding: longterm follow up of exposed children in a case-series of mothers with chronic arthritides. Ann Rheum Dis 2016;75 (Suppl 2):493. Abstract Abstract
  34. McConnell RA, Mahadevan U. Pregnancy and the Patient with Inflammatory Bowel Disease: Fertility, Treatment, Delivery, and Complications. Gastroenterol Clin North Am. 2016 Abstract
  35. 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
  36. 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)
  37. Grunewald S, Jank A. New systemic agents in dermatology with respect to fertility, pregnancy, and lactation. J Dtsch Dermatol Ges. 2015 Abstract Full text (link to original source) Full text (in our servers)
  38. Damas OM, Deshpande AR, Avalos DJ, Abreu MT. Treating Inflammatory Bowel Disease in Pregnancy: The Issues We Face Today. J Crohns Colitis. 2015 Oct;9(10):928-36. Abstract Full text (link to original source) Full text (in our servers)
  39. Nielsen OH, Maxwell C, Hendel J. IBD medications during pregnancy and lactation. Nat Rev Gastroenterol Hepatol. 2014 Feb;11(2):116-27. Abstract
  40. Witzel SJ. Lactation and the use of biologic immunosuppressive medications. Breastfeed Med. 2014 Dec;9(10):543-6. Abstract Full text (link to original source) Full text (in our servers)
  41. 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)
  42. Huang VW, Habal FM. From conception to delivery: managing the pregnant inflammatory bowel disease patient. World J Gastroenterol. 2014 Abstract Full text (link to original source) Full text (in our servers)
  43. 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
  44. Mervic L. Management of moderate to severe plaque psoriasis in pregnancy and lactation in the era of biologics. Acta Dermatovenerol Alp Pannonica Adriat. 2014;23(2):27-31. Abstract Full text (link to original source) Full text (in our servers)
  45. 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)
  46. Julsgaard M, Brown S, Gibson P, Bell S. Adalimumab levels in an infant. J Crohns Colitis. 2013 Abstract
  47. Mahadevan U, Wolf DC, Dubinsky M, Cortot A, Lee SD, Siegel CA, Ullman T, Glover S, Valentine JF, Rubin DT, Miller J, Abreu MT. Placental transfer of anti-tumor necrosis factor agents in pregnant patients with inflammatory bowel disease. Clin Gastroenterol Hepatol. 2013 Mar;11(3):286-92; quiz e24. Abstract Full text (link to original source) Full text (in our servers)
  48. Pistilli B, Bellettini G, Giovannetti E, Codacci-Pisanelli G, Azim HA Jr, Benedetti G, Sarno MA, Peccatori FA. Chemotherapy, targeted agents, antiemetics and growth-factors in human milk: how should we counsel cancer patients about breastfeeding? Cancer Treat Rev. 2013 May;39(3):207-11. Abstract
  49. Fritzsche J, Pilch A, Mury D, Schaefer C, Weber-Schoendorfer C. Infliximab and adalimumab use during breastfeeding. J Clin Gastroenterol. 2012 Sep;46(8):718-9. Abstract
  50. Bae YS, Van Voorhees AS, Hsu S, Korman NJ, Lebwohl MG, Young M, Bebo B Jr, Kimball AB; National Psoriasis Foundation. Review of treatment options for psoriasis in pregnant or lactating women: from the Medical Board of the National Psoriasis Foundation. J Am Acad Dermatol. 2012 Abstract
  51. EMA-AbbVie. Adalimumab (Humira). Drug Summary. 2010 Full text (in our servers)
  52. Fischer-Betz RE, Schneider M. [Biologics during pregnancy and breast--feeding]. Z Rheumatol. 2010 Abstract
  53. 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)
  54. Ben-Horin S, Yavzori M, Katz L, Picard O, Fudim E, Chowers Y, Lang A. Adalimumab level in breast milk of a nursing mother. Clin Gastroenterol Hepatol. 2010 Abstract
  55. Mahadevan U. Pregnancy, Fertility, and Therapies for IBD. Gastroenterol Hepatol (N Y). 2006 Apr;2(4):234-236. No abstract available. Abstract
  56. 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)
  57. Mishkin DS, Van Deinse W, Becker JM, Farraye FA. Successful use of adalimumab (Humira) for Crohn's disease in pregnancy. Inflamm Bowel Dis. 2006 Aug;12(8):827-8. No abstract available. Abstract
  58. Vesga L, Terdiman JP, Mahadevan U. Adalimumab use in pregnancy. Gut. 2005 Jun;54(6):890. No abstract available. Abstract

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