Contraception Requirements for Enbrel and Humira
Women of childbearing potential do not need to use contraception while taking Enbrel (etanercept) or Humira (adalimumab), as these medications are considered compatible with pregnancy and are not teratogenic. 1
Key Evidence Supporting Safety
Pregnancy Compatibility
Both TNF inhibitors can be continued throughout pregnancy according to the most recent 2025 EULAR guidelines, which found no association with increased risk of congenital malformations, miscarriage, or other adverse pregnancy outcomes 1
The 2020 American College of Rheumatology guidelines conditionally recommend continuing etanercept, adalimumab, and other TNF inhibitors prior to and during pregnancy 1
Current evidence from meta-analyses demonstrates that TNF inhibitors (including adalimumab and etanercept) are not associated with increased rates of birth defects compared to background population rates 1
FDA Drug Label Information
The Humira (adalimumab) FDA label states that "you and your doctor should decide if you should take HUMIRA while you are pregnant or breastfeeding," but does not mandate contraception use 2
The Enbrel (etanercept) FDA label reports that studies showed no statistically significant increased risk of minor birth defects and no pattern of major or minor birth defects in exposed pregnancies 3
Important Timing Considerations
Third Trimester Management
While contraception is not required, there are nuanced recommendations about timing if pregnancy occurs:
Etanercept (Enbrel) can be continued until gestational week 30-32 if disease control requires it 1
Adalimumab (Humira) may be discontinued by gestational week 20 if disease is well-controlled, though continuation is acceptable for active disease 1
The rationale for potential third-trimester discontinuation relates to placental transfer and neonatal drug levels, not teratogenicity 1
Breastfeeding Compatibility
Both medications are compatible with breastfeeding, with etanercept present in low levels in breast milk but not detected in infant plasma 3
TNF inhibitors are strongly recommended for continuation during breastfeeding 1
Clinical Pitfalls to Avoid
Do not confuse TNF inhibitors with truly teratogenic medications like methotrexate, leflunomide, or mycophenolate, which do require contraception and discontinuation before conception 1
Do not unnecessarily discontinue these medications in women planning pregnancy, as uncontrolled inflammatory disease poses greater risks to pregnancy outcomes than the medications themselves 1
Counsel patients appropriately that while contraception is not medically required for these specific biologics, pregnancy planning discussions should still occur to optimize disease control and medication timing 1