Anise

Pregnancy

The EMA monographs for aniseed and anise oil, both dated 12 November 2013, say available information does not establish effects in pregnancy and lactation and does not recommend use because data are insufficient. The aniseed monograph reports no fertility data. No human pregnancy study specific to anise was identified in this review, so birth-defect, miscarriage, and trimester-specific outcome claims are not verified. EMA's 2021 estragole statement names Pimpinella anisum fruit as an estragole-containing plant and says exposure from herbal medicinal products should be as low as practically achievable. For pregnant and breastfeeding people, it does not recommend estragole-containing herbal medicinal products when daily intake exceeds its 0.05 mg/person guidance value unless an adequate-data risk assessment justifies use. The statement says an exact general limit cannot be defined; this is not an anise-specific dose estimate and does not equate culinary use with medicinal products.

Breastfeeding

LactMed describes anise as a traditional or purported galactagogue but says few scientifically valid trials support this use. In a 2023 randomized clinical trial, 145 mothers of infants born before 32 weeks enrolled and 129 were analyzed. The intervention was 2 g dried anise seed plus 1 g black tea, three times daily for 7 days; the comparison groups received black tea or no intervention. The trial reported higher pumped milk volumes in the anise group on days 1 and 3 through 7, with no statistically significant infant-weight differences on days 0, 3, or 7; no adverse side effects were reported by participants, and follow-up ended at 7 days. Cragg et al.'s 2026 review included this one anise trial and rated the day-7 milk-volume difference low certainty: 98.0 mL (95% CI 63.2 to 132.8; 129 participants); the infant-weight difference was 9.2 g (95% CI -55.8 to 74.2; 90 participants), also low certainty, with no long-term follow-up. The 2020 Cochrane review of mothers of healthy term infants did not study anise as a standalone herb and found results for natural galactagogues very uncertain. The 2018 ABM protocol says it cannot recommend a specific galactagogue; its stated five-year validity period has elapsed.

What was tested

The anise-specific human trial tested a brewed tea made from 2 g dried anise seed and 1 g black tea, taken three times daily for one week by mothers pumping milk for hospitalized preterm infants born before 32 weeks. It did not test anise oil, ordinary food seasoning, longer use, or mothers of term infants. The trial and review do not establish a dose or effect for other products or preparations.