Medication safety during pregnancy and breastfeeding and effects on female and male fertility
Medication Considerations During Pregnancy Breastfeeding and in Men
Pregnancy | Breastfeeding | Men | Other Considerations | |
|---|---|---|---|---|
| Corticosteroids | Compatible; optimally <20 mg/day; potential increased risk of oral cleft, preterm birth, and low birth weight at higher doses | Compatible; optimally wait 2 hours after dose to breastfeed | Long-term use can be associated with decreased testosterone levels | Difficult to determine if risks during pregnancy are independent of maternal disease activity |
| Methotrexate | Contraindicated; teratogenic | Not recommended; insufficient data | Possible/low risk of teratogenicity and reversible azoospermia | Before planned pregnancy, discontinue at least 1 month in women and 3 months in men |
| Leflunomide | Contraindicated; teratogenic; if planning pregnancy, check blood level prior to ensure undetectable; if taking and unplanned pregnancy, administer cholestyramine | Not recommended; insufficient data | Insufficient data | Before planned pregnancy in women or men, discontinue 3.5 months to 2 years prior or consider cholestyramine |
| Sulfasalazine | Compatible; folate supplementation needed | Compatible | Reversible azoospermia that resolves 2–3 months after discontinuation | |
| Hydroxychloroquine | Compatible; reduces risk of SLE flare in pregnancy; may improve pregnancy outcomes in SLE | Compatible | No known risk | |
| Azathioprine | Compatible; crosses placenta but fetal liver lacks the enzyme to convert to the active metabolite | Compatible | Limited data but no known risk | |
| Mycophenolate mofetil | Contraindicated; teratogenic; increased risk of first trimester pregnancy loss | Not recommended; insufficient data | Possible teratogenicity | Before planned pregnancy, discontinue at least 6 weeks in women and 3 months in men |
| Antitumor necrosis factor α agents | Compatible; if pregnant and taking, consider discontinuation during third trimester when placental transfer occurs | Compatible | Limited data but no known risk | Certolizumab has no active placental transfer |
| Cyclophosphamide | Contraindicated; teratogenic; dose- and age-dependent infertility including premature ovarian failure | Contraindicated | Dose-dependent infertility including irreversible azoospermia | In men and women, consider waiting 6–12 months before planned pregnancy |
| Cyclosporine and tacrolimus | Compatible; potential risk of preterm birth and low birth weight reported, but difficult to determine if risk is independent of other maternal factors | Not recommended; insufficient data | Limited data, but no known risk | Tacrolimus dose may need to be increased during pregnancy |
| Abatacept, rituximab, belimumab, anti-IL6, anti-IL17, and JAK inhibitors | Not recommended; insufficient data | Insufficient data, but antibodies probably safe | Insufficient data | Most IgG molecules cross placenta in the second trimester and can therefore reach fetal circulation at that time |
| Colchicine | Compatible; potential risk of preterm birth and low birth weight, but difficult to determine if risk is independent of other maternal factors | Compatible | Limited data, but no known risk | No need to hold in pregnant women with familial Mediterranean fever |
| Nonsteroidal antiinflammatory drugs | Risk of miscarriage when used during the first trimester. Stop in third trimester to prevent premature closure of the fetal ductus arteriosus | Compatible | Safe to use, but daily use, particularly for aspirin, could potentially reduce fertility | Could inhibit ovulation, consider avoiding days 8–20 of the menstrual cycle for planned pregnancy |
| ACEi/ARB | Contraindicated in second and third trimester due to fetal renal effects | No known risk with enalapril and captopril; insufficient data for other ACEi/ARBs | Compatibl |
ACEi, Angiotensin-converting enzyme inhibitor; ARB, angiotensin-receptor blocker; IL, interleukin; JAK, Janus kinase; SLE, systemic lupus erythematosus.Compatible = low risk with no clear evidence of harm to fetus or infant.Any medication not clinically indicated or needed should be avoided in pregnancy, with the exception of hydroxychloroquine, which should be continued during pregnancy in lupus to reduce the risk of flare.Must always consider fetal risk of the medication versus fetal risk if disease flares.Although most medications in the chart have been detected in small amounts in breast milk, those listed as compatible have been used historically without safety concerns.Letter-based categories (i.e., A, B, C, D, and X) for medication risks in pregnancy and lactation are often confusing and not always clinically helpful. Therefore, in June 2015, the Food and Drug Administration implemented new Pregnancy and Lactation Labeling Rule that will phase out letter-based categories over the next several years.
