Can tofacitinib be used during pregnancy?

Medical Advisory BoardAll articles are reviewed for accuracy by our Medical Advisory Board
Educational purpose only • Exercise caution as content is pending human review
Article Review Status
Submitted
Under Review
Approved

Last updated: October 9, 2026 • View editorial policy

Have a follow-up question?

Our Medical A.I. is used by practicing medical doctors at top research institutions around the world. Ask any follow up question and get world-class guideline-backed answers instantly.

Ask Question

Tofacitinib Should Be Discontinued At Least 4 Weeks Before Conception and Avoided During Pregnancy

Tofacitinib should be discontinued at least 4 weeks prior to conception unless there is no effective alternative therapy to maintain maternal health, and it should not be used during pregnancy. 1

Guideline Recommendations

The most recent and authoritative guidance comes from the 2025 Global Consensus Statement on the Management of Pregnancy in Inflammatory Bowel Disease, which provides clear direction:

  • Women with IBD should discontinue tofacitinib at least 4 weeks prior to conception unless there is no effective alternative therapy to maintain maternal health 1
  • Pregnant women with active disease should start or optimize appropriate therapies as in nonpregnant patients, EXCEPT for Janus kinase inhibitors (which includes tofacitinib) 1

The 2025 EULAR recommendations similarly state that drugs with insufficient safety data, including tofacitinib, should be avoided until further evidence is available 2

The 2020 American College of Rheumatology guideline notes that there is no available evidence regarding use or safety of tofacitinib during pregnancy, and the Voting Panel elected not to offer recommendations regarding this drug, while emphasizing that small molecules like tofacitinib are likely to pass through the placenta 3

Why This Recommendation Exists

Placental Transfer

Unlike large biologic molecules that don't cross the placenta significantly until the second trimester, tofacitinib is a small molecule (molecular weight ~312 Da) that likely crosses the placenta from the beginning of pregnancy 3, 4. This means fetal exposure occurs during the critical period of organogenesis (weeks 3-8).

Animal Data Concerns

The FDA drug label reveals concerning animal data: tofacitinib was teratogenic and fetocidal in rats and rabbits at exposures 73-times and 6.3-times the maximum recommended human dose, respectively 5. Specific malformations included:

  • Membranous ventricular septal defects
  • Skeletal malformations (absent cervical arch, bent long bones, sternoschisis)
  • Increased post-implantation loss and reduced fetal body weight

Limited Human Data

The available human data is insufficient to draw conclusions. The FDA label states that data from only 11 exposed patients in a pregnancy registry, plus pharmacovigilance and published literature, are insufficient to draw conclusions about drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes 5.

A 2026 analysis of 85 maternal exposure events showed: 46 healthy newborns, 12 medical terminations, 1 fetal death, 1 congenital malformation, and 14 spontaneous abortions 6. While outcomes appeared similar to the general population, the sample size is too small for definitive conclusions.

Clinical Decision-Making Algorithm

For Women Planning Pregnancy:

  1. Discontinue tofacitinib at least 4 weeks before attempting conception 1
  2. Transition to pregnancy-compatible medications (e.g., anti-TNF agents like certolizumab, vedolizumab, or ustekinumab depending on the condition)
  3. Only continue tofacitinib if:
    • No effective alternative therapy exists to maintain maternal health AND
    • Uncontrolled disease poses greater risk than potential fetal exposure
    • This requires explicit shared decision-making with full disclosure of limited safety data

For Women Who Become Pregnant on Tofacitinib:

  1. Discontinue immediately upon positive pregnancy test
  2. Transition to pregnancy-compatible alternative
  3. Counsel that the risk of uncontrolled disease activity during pregnancy (preterm delivery, low birth weight, small for gestational age) may outweigh theoretical medication risks 5

For Severe Disease During Pregnancy:

The 2025 IBD consensus acknowledges that controlling disease activity during pregnancy is critical to reduce adverse outcomes 1. If disease cannot be controlled with pregnancy-compatible medications, the physician and patient must weigh:

  • Risks of uncontrolled disease (preterm birth, low birth weight, disease complications)
  • Theoretical risks from tofacitinib (unknown human teratogenicity, animal data concerns)

The FDA label states tofacitinib can be used during pregnancy only if the potential benefit justifies the potential risk to the fetus 7, but this should be considered only in exceptional circumstances.

Critical Caveats

Do not use the dermatology guideline's permissive language as justification. The 2020 AAD-NPF psoriasis guideline states "tofacitinib can be used during pregnancy only if the potential benefit justifies the potential risk" 7, but this is expert consensus from 2020, predating the more restrictive 2025 IBD and EULAR guidelines that explicitly recommend discontinuation before conception.

The 4-week washout period is based on pharmacokinetics to ensure drug elimination before conception, though the exact rationale for this specific timeframe is not detailed in the guidelines.

Breastfeeding is also contraindicated - mothers on tofacitinib should not breastfeed 1, 2

Paternal exposure appears safe - pregnancy outcomes with paternal tofacitinib exposure (99 events, 67 healthy newborns) showed no concerning patterns 6, 4

References

Related Questions

Is it safe to breastfeed while taking tofacitinib (Xeljanz)?
In a patient with severe ulcerative colitis receiving intravenous hydrocortisone 100 mg three times daily for 7 days and still having 8–9 loose stools daily, who will be started on tofacitinib 10 mg twice daily for 8 weeks (then 5 mg twice daily) because he cannot afford TNF‑α inhibitors, how should the hydrocortisone injection be tapered or discontinued when initiating tofacitinib?
How should I perform and interpret a tuberculin skin test (TST) for a patient who will be started on tofacitinib, including management of positive or negative results?
What are the recommended dosing, monitoring, adverse effects, and alternative treatment options for tafacitinib in inflammatory bowel disease such as ulcerative colitis and Crohn’s disease?
In a patient with autoimmune hepatitis on mycophenolate mofetil, can a Janus kinase (JAK) inhibitor be used to control his ulcerative colitis?
In a 53-year-old patient with BMI 28 kg/m², fasting glucose 89 mg/dL, and a glucose level of 35 mg/dL two hours after an oral glucose tolerance test, what is the appropriate next management?
What oral antibiotic regimen is appropriate for an adult with a dental abscess?
How should Dandy‑Walker malformation of the posterior fossa be evaluated and managed?
How should a dual‑energy X‑ray absorptiometry (DEXA) scan be interpreted and when is zoledronic acid indicated?
What safety concerns and side effects do immunologists associate with mRNA COVID‑19 vaccines (Pfizer‑BNT162b2 and Moderna‑mRNA‑1273), including myocarditis, pericarditis, anaphylaxis, and reduced efficacy in patients with uncontrolled autoimmune disease or on high‑dose immunosuppressants?
How should I switch a patient with high blood glucose who is on glimepiride 2 mg twice daily to gliclazide 60 mg extended‑release twice daily?

Professional Medical Disclaimer

This information is intended for healthcare professionals. Any medical decision-making should rely on clinical judgment and independently verified information. The content provided herein does not replace professional discretion and should be considered supplementary to established clinical guidelines. Healthcare providers should verify all information against primary literature and current practice standards before application in patient care. Dr.Oracle assumes no liability for clinical decisions based on this content.