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Testosterone Pregnancy and Breastfeeding Warnings

Testosterone is also known as: Andro-Cyp 100, AndroGel, Androderm, Aveed, Axiron, Delatest, Delatestryl, Depo-Testosterone, Depotest, Everone, FIRST-Testosterone, FIRST-Testosterone MC, Fortesta, Natesto, Striant, Testamone-100, Testim, Testoderm, Testolin, Testopel, Testopel Pellets, Testro AQ, Virilon IM, Vogelxo, Xyosted

Medically reviewed on Aug 15, 2017

Testosterone Pregnancy Warnings

Testosterone has been tested by subcutaneous injection and implantation in mice and rats. The implant induced cervical-uterine tumors in mice, which metastasized in some cases. Testosterone is also known to increase the number of tumors and decrease the degree of differentiation of chemically induced carcinomas of the liver in rats. There are no adequate data for the use of this drug in pregnant women.

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.

Use is contraindicated.

AU TGA pregnancy category: D
US FDA pregnancy category: X

Comments:
-Treatment with this drug should be discontinued immediately if pregnancy occurs and the potential hazard to the fetus should be evaluated.
-There is a potential for transfer of testosterone from men treated with this drug to women who are or may become pregnant.
-Treatment with androgens can lead to fertility disorders by repressing sperm-formation (or causing oligospermia) in male patients, and to infrequent or repressed menstrual cycle in female patients.
-Exposure of a fetus to androgens may result in varying degrees of virilization.

See references

Testosterone Breastfeeding Warnings

Use is contraindicated.

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

Comments:
-The effects in the nursing infant are unknown.
-Exposure of a nursing infant to androgens may result in varying degrees of virilization.

See references

References for pregnancy information

  1. "Product Information. Fortesta (testosterone)." Endo Pharmaceuticals (formally Indevus Pharmaceuticals Inc), Lexington, MA.
  2. Mandelbaum JM, Simon NM "Severe methyprylon intoxication treated by hemodialysis." JAMA 216 (1971): 139-40
  3. "Product Information. Testopel (testosterone)." Bartor Pharmacal Co, Inc, Rye, NY.
  4. "Product Information. Androderm (testosterone topical)." SmithKline Beecham, Philadelphia, PA.
  5. "Product Information. Aveed (testosterone)." Endo Pharmaceuticals Solutions Inc, Malvern, PA.
  6. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  7. "Product Information. Depo-Testosterone (testosterone)." Pfizer U.S. Pharmaceuticals Group, New York, NY.
  8. Cerner Multum, Inc. "Australian Product Information." O 0
  9. "Product Information. Testosterone Enanthate (testosterone)." West-Ward Pharmaceutical Corporation, Eatontown, NJ.
  10. "Product Information. Axiron (testosterone)." Lilly, Eli and Company, Indianapolis, IN.
  11. "Product Information. Testim (testosterone)." A-S Medication Solutions, Chicago, IL.

References for breastfeeding information

  1. "Product Information. Fortesta (testosterone)." Endo Pharmaceuticals (formally Indevus Pharmaceuticals Inc), Lexington, MA.
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. "Product Information. Testosterone Enanthate (testosterone)." West-Ward Pharmaceutical Corporation, Eatontown, NJ.
  4. "Product Information. Axiron (testosterone)." Lilly, Eli and Company, Indianapolis, IN.
  5. "Product Information. AndroGel (testosterone)." Unimed Pharmaceuticals, Buffalo Grove, IL.
  6. Cerner Multum, Inc. "Australian Product Information." O 0
  7. "Product Information. Aveed (testosterone)." Endo Pharmaceuticals Solutions Inc, Malvern, PA.
  8. "Product Information. Testopel (testosterone)." Bartor Pharmacal Co, Inc, Rye, NY.
  9. "Product Information. Androderm (testosterone topical)." SmithKline Beecham, Philadelphia, PA.
  10. "Product Information. Depo-Testosterone (testosterone)." Pfizer U.S. Pharmaceuticals Group, New York, NY.

Further information

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

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