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Pyrazinamide Pregnancy and Breastfeeding Warnings

Medically reviewed by Drugs.com. Last updated on Jan 22, 2025.

Pyrazinamide Pregnancy Warnings

This drug should be used during pregnancy only if clearly needed.

US FDA pregnancy category: Not assigned

Risk summary: No data are available on the use of this drug in pregnant women to inform a drug-related risk.

Animal studies have not been reported. There are no controlled data in human pregnancy.

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.

See references

Pyrazinamide Breastfeeding Warnings

Caution is recommended; benefit to mother should outweigh risk to the infant.
-Some experts recommend: A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.

Excreted into human milk: Yes

Comments:
-The WHO classifies this drug as compatible with breastfeeding; the breastfed infant should be monitored for jaundice.
-The US Centers for Disease Control and Prevention and other professional organizations state breastfeeding should not be discouraged in women taking this drug.
-Some experts recommend: Exclusively breastfed infants should be monitored for the signs/symptoms of toxicity (e.g., arthralgia, fever, hepatitis, jaundice, loss of appetite, nausea, rash, thrombocytopenia, vomiting).

See references

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References for pregnancy information

  1. (2001) "Product Information. Pyrazinamide (pyrazinamide)." VersaPharm Inc
  2. (2022) "Product Information. Pyrazinamide (pyrazinamide)." Macleods Pharma USA, Inc

References for breastfeeding information

  1. (2001) "Product Information. Pyrazinamide (pyrazinamide)." VersaPharm Inc
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics."
  3. Department of Adolescent and Child Health and Development. UNICEF. World Health Organization (2014) Breastfeeding and maternal medication: recommendations for drugs in the eleventh Who model list of essential drugs. http://whqlibdoc.who.int/hq/2002/55732.pdf?ua=1
  4. Briggs GG, Freeman RK. (2015) "Drugs in Pregnancy and Lactation." Philadelphia, PA: Wolters Kluwer Health

Further information

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