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Alprostadil Pregnancy and Breastfeeding Warnings

Brand names: Caverject, Caverject Impulse, Edex, Edex Refill, Muse, Prostin VR Pediatric

Medically reviewed by Drugs.com. Last updated on Aug 8, 2024.

Alprostadil Pregnancy Warnings

This drug is not indicated for use in female patients.

AU TGA pregnancy category: Not formally assigned to a pregnancy category
US FDA pregnancy category: Not assigned.

Risk summary: Based on animal data, this drug may cause fetal harm; animal studies have revealed evidence of embryotoxicity at clinically relevant doses.

Comments: Male partners should use a condom during intercourse.

Animal studies have revealed evidence of embryotoxicity. There are no controlled data in human pregnancy.

This drug is chemically identical to prostaglandin E1 (PGE1), which occurs naturally in seminal fluid. Use of this drug may add to the amount of PGE1 present in the seminal fluid. Male partners should use a condom during intercourse to avoid vaginal irritation and risk of preterm delivery.

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

Alprostadil Breastfeeding Warnings

This drug is not indicated for use in women.

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

See references

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See also

References for pregnancy information

  1. (2001) "Product Information. Edex (alprostadil)." Schwarz Pharma
  2. "Product Information. Caverject (alprostadil)." Pharmacia and Upjohn
  3. (2001) "Product Information. Muse (alprostadil)." Vivus LLC.
  4. "Product Information. Prostin VR Pediatric (alprostadil)." Pharmacia and Upjohn
  5. Cerner Multum, Inc. "UK Summary of Product Characteristics."
  6. Cerner Multum, Inc. "Australian Product Information."
  7. (2022) "Product Information. Caverject (alprostadil)." Pfizer U.S. Pharmaceuticals Group
  8. (2024) "Product Information. Edex (alprostadil)." Endo Laboratories LLC
  9. (2022) "Product Information. Prostin VR Pediatric (alprostadil)." Pfizer U.S. Pharmaceuticals Group
  10. (2024) "Product Information. Muse (alprostadil)." Meda Pharmaceuticals

References for breastfeeding information

  1. (2001) "Product Information. Edex (alprostadil)." Schwarz Pharma
  2. "Product Information. Caverject (alprostadil)." Pharmacia and Upjohn
  3. (2001) "Product Information. Muse (alprostadil)." Vivus LLC.
  4. "Product Information. Prostin VR Pediatric (alprostadil)." Pharmacia and Upjohn
  5. Cerner Multum, Inc. "UK Summary of Product Characteristics."
  6. Cerner Multum, Inc. "Australian Product Information."

Further information

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

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