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Methotrexate Pregnancy and Breastfeeding Warnings

Brand names: Folex PFS, Jylamvo, Methotrexate LPF Sodium, Otrexup, Rasuvo, RediTrex, Rheumatrex Dose Pack, Trexall, Xatmep

Medically reviewed by Drugs.com. Last updated on May 8, 2023.

Methotrexate Pregnancy Warnings

This drug causes teratogenic effects, embryotoxicity, abortion, and fetal defects in humans. It has also been reported to cause impairment of fertility, oligospermia, and menstrual dysfunction in humans, during and for a short period after cessation of therapy.

A study examined the effects of this drug on pregnancy outcomes. The study found that pregnant women exposed to this drug at a dose equal to or less than 30 mg/week had a higher rate of spontaneous abortion/miscarriage (42.5%) compared to both unexposed patients with autoimmune disease (22.5%) and unexposed patients with non-autoimmune disease (17.3%). Additionally, among live births, pregnant women exposed to methotrexate had a higher rate of major birth defects compared to both groups of unexposed patients (2.9%). The study concluded that the major birth defects observed in pregnancies exposed to methotrexate were not always consistent with the expected adverse developmental outcomes associated with methotrexate use.

AU TGA pregnancy category D: Drugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects. Accompanying texts should be consulted for further details.

US FDA pregnancy category X: Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits.

US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D and X are being phased out.

AU, UK: Use is contraindicated.
US: Use is contraindicated for all indications except oncology.

AU TGA pregnancy category: D
US FDA pregnancy category: X (psoriasis and rheumatoid arthritis); Not assigned (all other conditions)

Risk Summary: This drug can cause teratogenic effects or fetal death when administered to a pregnant woman.

Comments:
-This drug should be used in the treatment of neoplastic diseases only when the potential benefit outweighs the risk to the fetus.
-This drug affects spermatogenesis and oogenesis and may temporarily impair fertility.
-If the injection formulation of this drug is required to treat a neoplastic disease during pregnancy, it is advisable to opt for the preservative-free formulation since benzyl alcohol, which is a preservative, can pass through the placenta.
-Women of childbearing potential should not be started on this drug until pregnancy is excluded and should be fully counseled on the serious risk to the fetus should they become pregnant while undergoing treatment.
-Pregnancy should be avoided if either partner is receiving this drug, during and for a minimum of 3 months after therapy is completed for male patients, and during and for at least one ovulatory cycle after therapy is completed for female patients.
-Advise females of reproductive potential to use effective contraception during and for 6 months after the final dose of this drug.

See references

Methotrexate Breastfeeding Warnings

Use is contraindicated.

Excreted into human milk: Yes

Comments:
-The effects in the nursing infant or on milk production are unknown.
-Lactating women should be instructed not to breastfeed during treatment with this drug and for 1 week after the final dose.

Limited literature is available regarding the presence of this drug in human milk, indicating that it is present in minimal quantities. The highest ratio of this drug concentration in breast milk compared to plasma concentration reported is 0.08:1.

See references

References for pregnancy information

  1. Cerner Multum, Inc. UK Summary of Product Characteristics.
  2. Cerner Multum, Inc. Australian Product Information.
  3. Product Information. Methotrexate Sodium (methotrexate). Teva Pharmaceuticals (formerly IVAX). 2017.

References for breastfeeding information

  1. Cerner Multum, Inc. UK Summary of Product Characteristics.
  2. Cerner Multum, Inc. Australian Product Information.
  3. United States National Library of Medicine. Toxnet. Toxicology Data Network. http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT 2013.
  4. Product Information. Methotrexate Sodium (methotrexate). Teva Pharmaceuticals (formerly IVAX). 2017.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.