Tacrolimus (all routes)

Exposed non-exposed studies (cohort)

Study Country
Study period
Population source Exposure definition Non-exposure definition Sample size Rmk
Al-Otaibi, 2019 Kuwait
2004 - 2017
Renal transplant recipients who became pregnant during the study period. Pregnant women maintained on tacrolimus-based regimen (all patients also maintained on steroids plus azathioprine). exposed to other treatment, sick
Pregnant women maintained on cyclosporin-based regimen (all patients also maintained on steroids plus azathioprine).
33 / 49
Alvaro, 2013 Spain
1986 - 2011
Females with orthotopic liver transplantation who became pregnant during the study period. Pregnant women with orthotopic liver transplantation using tacrolimus during pregnancy. exposed to other treatment, sick
Pregnant women with orthotopic liver transplantation using cyclosporine during pregnancy.
15 / 5 No mention of mycophenomate mofetil.
Ichinose, 2018 Japan
2008 - 2016
Patients with systemic lupus erythematosus who had deliveries during the study period who were admitted to the study centers. Mothers with systemic lupus erythematosus treated with tacrolimus during the pregnancy. unexposed, sick
Mothers with systemic lupus erythematosus never treated with tacrolimus during pregnancy.
15 / 39 The patients for whom tacrolimus treatment was terminated during a pregnancy were excluded.
Kim, 2015 Seoul, Korea
1991 - 2012
All women who delivered babies after having undergone kidney transplantation at those hospitals between the study period. Deliveries given tacrolimus-based immunosuppressants mostly combined with azathioprine and/or steroids (prednisolone or methylprednisolone). exposed to other treatment, sick
Deliveries given cyclosporine-based immunosuppressants mostly combined with azathioprine and/or steroids (prednisolone or methylprednisolone).
28 / 60 None of the pregnancies were exposed to mycophenolic acid.
Perales-Puchalt, 2012 Valencia, Spain
1995 - 2009
Pregnancies occurred in patients with normal functioning kidney transplants from deceased donors. Immunosuppressive drugs used was Tacrolimus. All patients used Prednisone as a co-adjuvant therapy. The treatment protocol of the patients remained unchanged during the study period. exposed to other treatment, sick
Immunosuppressive drugs used were Cyclosporine-A and four had a combination with Azathioprine. All patients used Prednisone as a co-adjuvant therapy. The treatment protocol of the patients remained unchanged during the study period.
9 / 11 Cyclosporine-A (CsA) and Azathioprine (AZA) groups could not be add because four pregnancies had a combination of CsA and AZA. Combinations are detailed and no mycophenolate mofetil involved.
Thompson, 2003 England
1976 - 2001
All pregnancies in the institute's renal transplant recipients Pregnant transplanted patients under tacrolimus, prednisolone and azathioprine. exposed to other treatment, sick
Pregnant transplanted patients under prednisolone, azathioprine -based regimens, with or without cyclosporine.
4 / 23 No mycophenolate mofetil.
Wielgos, 2012 Poland
2005 - 2010
Women with renal or liver transplantation, who had delivered during the study period. Pregnant women who underwent renal or liver transplantation treated with tacrolimus-based regimen (alone or with prednisolone and/or azathioprine). exposed to other treatment, sick
Pregnant women who underwent renal or liver transplantation treated with cyclosporine-based regimen (alone or with prednisolone and/or azathioprine)..
21 / 9 Data of patients treated with tacrolimus who underwent both renal and liver transplantation were added. None of women were treated with mycophenolate mofetil nor sirolimus during the time of pregnancy.

Case-control studies (cohort)

Study Country
Study period
Case Control Sample size Rmk
Sugawara, 2019 Japan
2007 - 2016
Pregnant women with any maternal and/or fetal complications. Pregnant women without any maternal and/or fetal complications. 34 / 23 Maternal adverse events: 34 cases and 23 controls. Fetal adverse events: 27 cases and 30 controls. Authors made some comparison with general obstetric population in Japan (GOP), but there is no distinction between treatments (results not reported here).

master protocol