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Guanfacine Pregnancy and Breastfeeding Warnings

Brand names: Intuniv, Tenex

Medically reviewed by Drugs.com. Last updated on May 6, 2025.

Guanfacine Pregnancy Warnings

This drug should be used during pregnancy only if clearly needed.
-According to some authorities: Use is not recommended.

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.

Comments:
-A pregnancy exposure registry is available.
-Adequate methods of contraception should be encouraged.

Animal studies revealed reduced fetal survival at doses that produced maternal toxicity. Placental transfer has been observed in animals. There are no controlled data in human pregnancy.

To monitor the outcomes of pregnant women exposed to this drug, a pregnancy registry has been established. Physicians are encouraged to register patients and pregnant women are encouraged to register themselves by calling 1-866-961-2388.

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

Guanfacine Breastfeeding Warnings

UK: A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.
US: Other agents may be preferred; otherwise, caution is recommended.

Excreted into human milk: Unknown
Excreted into animal milk: Yes

Comments: The effects in the nursing infant are unknown.

See references

Does Guanfacine interact with my other drugs?

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See also

References for pregnancy information

  1. (2001) "Product Information. Tenex (guanfacine)." Wyeth-Ayerst Laboratories
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics."
  3. (2009) "Product Information. Intuniv (guanfacine)." Shire US Inc
  4. (2025) "Product Information. GuanFACINE Hydrochloride (guanFACINE)." A2A Integrated Pharmaceuticals LLC

References for breastfeeding information

  1. (2001) "Product Information. Tenex (guanfacine)." Wyeth-Ayerst Laboratories
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics."
  3. (2009) "Product Information. Intuniv (guanfacine)." Shire US Inc
  4. United States National Library of Medicine (2013) Toxnet. Toxicology Data Network. http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT

Further information

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

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