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Aminocaproic acid Pregnancy and Breastfeeding Warnings

Brand names: Amicar

Medically reviewed by Drugs.com. Last updated on Apr 29, 2025.

Aminocaproic acid Pregnancy Warnings

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

US FDA pregnancy category:
-Oral tablet and solution: C
-IV infusion: 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 revealed decreased implantations, litter sizes, and number of pups born. There are no controlled data in human pregnancy.

US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

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

Aminocaproic acid Breastfeeding Warnings

Caution is recommended.

Excreted into human milk: Unknown
Excreted into animal milk: Data not available

Comments: The effects in the nursing infant are unknown.

See references

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References for pregnancy information

  1. (2001) "Product Information. Amicar (aminocaproic acid)." Immunex Corporation
  2. (2018) "Product Information. Aminocaproic Acid (aminocaproic acid)." Hospira Inc
  3. (2022) "Product Information. Amicar (aminocaproic acid)." Akorn Inc

References for breastfeeding information

  1. (2001) "Product Information. Amicar (aminocaproic acid)." Immunex Corporation

Further information

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