Ephedra
HerbalAlso called · 4 names▾▴
Chinese ephedra, ma huang, mahuang, Ephedra sinica
Herbal supplement (stimulant and weight loss)
Herbs and supplements are not FDA-approved before sale. About these sources
Research strength: 3 / 5
NCCIH advises against ephedra use during pregnancy, and Health Canada also advises against products containing ephedra or ephedrine during pregnancy. The FDA's 2004 final rule says dietary supplements containing ephedrine alkaloids present an “unreasonable risk of illness or injury”; the rule covers supplements, not over-the-counter or prescription medicines with ephedrine or pseudoephedrine. A 2008 study of weight-loss products containing ephedra found an association with anencephaly, a serious brain birth defect, but its authors said the finding might have been due to chance. A 2024 Japanese cohort found no statistically significant link with major birth defects among 376 users of multi-ingredient Kampo formulas containing ephedra; only eight cases occurred, so the estimate is uncertain. Ask your provider about your situation.
Last reviewed: 2026-10-16
Sources
- NCCIH: EphedraUS government
- Health Canada: Unauthorized products may pose serious health risksGovernment regulator
- FDA: Final Rule Declaring Dietary Supplements Containing Ephedrine Alkaloids Adulterated
- Bitsko et al., 2008: Periconceptional use of weight loss products including ephedra and birth defectsUS government
- Noda et al., 2024: Kampo medicines containing ephedra and major congenital malformationsUS government
Research strength: 3 / 5
NCCIH and Health Canada advise against ephedra products during pregnancy; the FDA's 2004 rule is specific to dietary supplements containing ephedrine alkaloids, not over-the-counter or prescription ephedrine or pseudoephedrine medicines. A 2025 Japanese cohort compared 699 users of multi-ingredient Kampo formulas containing ephedra with 1,069 acetaminophen users. It found no statistically significant association with several outcomes, including preterm birth and low birth weight, but estimates were wide. A second-trimester analysis included 415 formula users, and the study did not collect third-trimester use. Ask your provider about your situation.
Last reviewed: 2026-10-16
Sources
- NCCIH: EphedraUS government
- Health Canada: Unauthorized products may pose serious health risksGovernment regulator
- FDA: Final Rule Declaring Dietary Supplements Containing Ephedrine Alkaloids Adulterated
- Noda et al., 2025: Perinatal outcomes after use of Kampo medicines containing ephedraUS government
Research strength: 3 / 5
NCCIH and Health Canada advise against ephedra products during pregnancy; the FDA's 2004 rule applies to dietary supplements containing ephedrine alkaloids, not over-the-counter or prescription ephedrine or pseudoephedrine medicines. The 2025 Japanese study did not collect information on third-trimester Kampo use, so it cannot answer questions about that period. Its findings for selected outcomes earlier in pregnancy do not establish outcomes for Ephedra supplements. No third-trimester study of standalone Ephedra supplements is included in the cited sources. Ask your provider about your situation.
Last reviewed: 2026-10-16
Sources
- NCCIH: EphedraUS government
- Health Canada: Unauthorized products may pose serious health risksGovernment regulator
- FDA: Final Rule Declaring Dietary Supplements Containing Ephedrine Alkaloids Adulterated
- Noda et al., 2025: Perinatal outcomes after use of Kampo medicines containing ephedraUS government
Ephedra — Breastfeeding
Research strength: 1 / 5
NCCIH and Health Canada advise against ephedra or ephedrine products while breastfeeding. The FDA's 2004 rule applies to dietary supplements containing ephedrine alkaloids, not over-the-counter or prescription medicines containing ephedrine or pseudoephedrine. NCCIH's Ephedra page does not describe breast-milk measurements or infant follow-up, while MotherToBaby's general herbal sheet says information on herbal use during breastfeeding is limited. The cited pages do not establish an effect on a baby through milk; NCCIH does report serious cardiovascular and nervous system effects for the person taking ephedra. Ask your provider about your situation.
Last reviewed: 2026-10-16
Sources
- NCCIH: EphedraUS government
- Health Canada: Unauthorized products may pose serious health risksGovernment regulator
- MotherToBaby: Herbal ProductsTeratology service
- FDA: Final Rule Declaring Dietary Supplements Containing Ephedrine Alkaloids Adulterated
Pregnancy
The 2008 National Birth Defects Prevention Study case-control analysis found that self-reported periconceptional use of weight-loss products containing ephedra was associated with anencephaly (adjusted OR 2.8, 95% CI 1.0-7.3). The authors called the result hypothesis-generating and said the many exposure-outcome comparisons could mean it was due to chance. The analysis involved multi-ingredient weight-loss products, not ephedra alone. In Noda et al. 2024, 376 women used first-trimester Kampo formulas containing ephedra within a 20,879-person Japanese cohort; 8 exposed infants had major congenital malformations. The adjusted OR was 1.45 (95% CI 0.57-3.71) versus acetaminophen and 1.13 (95% CI 0.55-2.31) versus no medication in a sensitivity analysis; neither estimate was statistically significant. Noda et al. 2025 analyzed 20,083 participants, including 699 users of multi-ingredient Kampo formulas and 1,069 acetaminophen users. It found no statistically significant associations for cesarean section, preterm birth, low birth weight, small for gestational age, or low Apgar scores, but confidence intervals were wide. Both Noda reports use the TMM BirThree cohort; person-level overlap was not reported, so they are not separate independent cohort replications. The 2025 study did not collect third-trimester use data, and the 2025 analysis excluded 390 women with miscarriages or stillbirths, so it does not estimate miscarriage risk. No study directly tested a standalone Ephedra dietary supplement product.
Breastfeeding
The cited public pages provide no Ephedra-specific human milk measurements or infant follow-up. MotherToBaby's general herbal-products sheet says little information is available on herbal products during breastfeeding, but it does not evaluate Ephedra specifically. NCCIH and Health Canada advise against use during lactation; this does not document infant exposure or an effect through milk.
Ephedra is a botanical ingredient also called ma huang and may contain ephedrine alkaloids. The FDA's 2004 final rule states: “Dietary supplements containing ephedrine alkaloids present an unreasonable risk of illness or injury under conditions of use recommended or suggested in the labeling, or if no conditions of use are recommended or suggested in the labeling, under ordinary conditions of use. Therefore, dietary supplements containing ephedrine alkaloids are adulterated under section 402(f)(1)(A) of the Federal Food, Drug, and Cosmetic Act.” This rule concerns dietary supplements containing ephedrine alkaloids, not over-the-counter or prescription medicines containing ephedrine or pseudoephedrine. MotherToBaby notes that herbal preparations can vary in ingredients and strength and may contain ingredients not listed on the label.
What was tested
Bitsko et al. 2008 used self-reported periconceptional use of weight-loss products and assessed 23 birth-defect categories. The 2024 and 2025 Noda reports examined Japanese multi-ingredient Kampo formulas containing ephedra in the TMM BirThree cohort; they did not test a single-ingredient Ephedra supplement. The reports analyzed data from the same named cohort, although their person-level overlap was not reported. The 2025 report measured selected perinatal outcomes and did not collect third-trimester exposure; the cited studies did not assess breastfeeding or milk transfer.
How should the pregnancy cautions be read alongside human outcome studies?
- Source A says
- NCCIH and Health Canada advise against ephedra or ephedrine products during pregnancy and breastfeeding. The FDA's 2004 rule finds that dietary supplements containing ephedrine alkaloids present an unreasonable risk of illness or injury under labeled or ordinary conditions of use. (NCCIH: Ephedra, Health Canada: Unauthorized products may pose serious health risks, FDA: Final Rule Declaring Dietary Supplements Containing Ephedrine Alkaloids Adulterated)
- Source B says
- Bitsko et al. 2008 reported an association between ephedra-containing weight-loss products and anencephaly, but the authors said chance could explain the finding. The 2024 and 2025 Noda analyses found no statistically significant associations for selected outcomes in multi-ingredient Kampo formulas containing ephedra. (Bitsko et al., 2008: Periconceptional use of weight loss products including ephedra and birth defects, Noda et al., 2024: Kampo medicines containing ephedra and major congenital malformations, Noda et al., 2025: Perinatal outcomes after use of Kampo medicines containing ephedra)
- Why they differ
- The FDA rule evaluates overall supplement risk under labeled or ordinary use and is not a pregnancy-outcome estimate. Bitsko studied mixed weight-loss products and many exposure-outcome comparisons. The Noda reports studied specific multi-ingredient formulas in one Japanese cohort, with few exposed outcome events and wide confidence intervals. The sources therefore address different products and outcomes rather than one identical exposure question.
- Other sources
- MotherToBaby's general herbal-products sheet says multi-ingredient products are hard to study in pregnancy; it does not make an Ephedra-specific pregnancy finding. (MotherToBaby: Herbal Products)
- What the evidence shows overall
- The cohort findings add human evidence for selected Kampo formulas but do not establish outcomes for standalone Ephedra supplements. The 2008 association is uncertain, and the Noda estimates are imprecise. The studies do not overturn the FDA supplement risk finding or the advice from NCCIH and Health Canada to avoid use during pregnancy.
- MotherToBaby's general sheet suggests discussing an herbal product's purpose with a health care provider and asking about options with more pregnancy information. (MotherToBaby)
General research, not specific to pregnancy.
NCCIH lists cardiovascular and nervous system effects associated with ephedra, including high blood pressure, heart attack, seizure, stroke, and psychosis. The FDA's rule applies to dietary supplements containing ephedrine alkaloids.
- NCCIH reports that these effects have been linked to relatively low doses and short-term use. (NCCIH: Ephedra)
- The FDA's 2004 final rule states that dietary supplements containing ephedrine alkaloids present an unreasonable risk of illness or injury under labeled or ordinary conditions of use. (FDA: Final Rule Declaring Dietary Supplements Containing Ephedrine Alkaloids Adulterated)
- NCCIH: EphedraUS governmentSecondary
- MotherToBaby: Herbal ProductsTeratology serviceSecondaryIndependent check
- Health Canada: Unauthorized products may pose serious health risksGovernment regulatorSecondaryPage dated 2020-10-30Independent check
- FDA: Final Rule Declaring Dietary Supplements Containing Ephedrine Alkaloids AdulteratedSecondaryPage dated 2004-02-11
- Bitsko et al., 2008: Periconceptional use of weight loss products including ephedra and birth defectsUS governmentPrimary
- Noda et al., 2024: Kampo medicines containing ephedra and major congenital malformationsUS governmentPrimary
- Noda et al., 2025: Perinatal outcomes after use of Kampo medicines containing ephedraUS governmentPrimaryPage dated 2025-10-13
Last reviewed 2026-10-16
Independent check 2026-10-16
Not yet clinician-reviewed
Ask your provider about your situation.