Is Black Seed safe while breastfeeding?

Summary of use during breastfeeding

Black seed (Nigella sativa) contains an essential oil containing a wide variety of terpenes, thymoquinone, beta-elemene and other many constituents. Black seed and a related species (Nigella arvensis) have been used orally as galactogogues in India, Türkiye and the Middle East;[1-7] however, no scientifically valid clinical trials support this use in humans.[8] One study found a slightly greater increase in serum prolactin than placebo, but no evidence of growth promotion in infants.[9] Galactogogues should never replace evaluation and counseling on modifiable factors that affect milk production.[10,11] The oil has also been used topically. No data exist on the excretion of any components of black seed into breastmilk or on the safety and efficacy of black seed in infants. Limited information indicates that black seed is generally well tolerated. Black seed oil can cause allergic contact dermatitis.

Dietary supplements do not require extensive pre-marketing approval from the U.S. Food and Drug Administration. Manufacturers are responsible to ensure the safety, but do not need to prove the safety and effectiveness of dietary supplements before they are marketed. Dietary supplements may contain multiple ingredients, and differences are often found between labeled and actual ingredients or their amounts. A manufacturer may contract with an independent organization to verify the quality of a product or its ingredients, but that does not certify the safety or effectiveness of a product. Because of the above issues, clinical testing results on one product may not be applicable to other products. More detailed information about dietary supplements is available elsewhere on the LactMed Web site.

Effects on the breastfed infant

Relevant published information was not found as of the revision date.

Effects on milk supply

One hundred fifty-eight mothers in Iran of who reported difficulty in breastfeeding were given either a proprietary mixture of herbs (Shirafza Drop) or a chlorophyll solution as a placebo. The herbal mixture contained the purported galactogogues fennel, anise, cumin, black seed, and parsley. Infant ages ranged between 0 and 6 months and they were exclusively breastfed. Weight gain of the infants was measured over time. No difference in infant weight gain was seen between the two groups of infants.[12] Blinding and randomization in this study is unclear.

A single-blinded study was performed on mothers having baby of 1 month of age or less with complaints of insufficient breast milk secretion and poor anthropometric measures of her child (weight, height, head circumference). Mothers were randomly assigned to receive either 1 gram of ground Nigella sativa seeds (n = 50) or 1 gram of a cellulose placebo (n = 50) twice daily for 28 days. Serum prolactin increased from 75 to 192 (units not specified) in the Nigella group which was slightly greater than in the control group. Babies in both groups gained weight, length and head circumference, but no difference was seen between the two groups. There were also no changes in maternal serum hemoglobin, creatinine, AST and ALT levels or differences between the groups.[9]

Levels in milk

Maternal Levels. Relevant published information was not found as of the revision date.

Infant Levels. Relevant published information was not found as of the revision date.