Roxithromycin pregnancy category - Pregnancy drugs

Complete list of drugs used during pregnancy and lactation, its category as per FDA explained here, PG drugs teratogenic effect of drugs used during pregnancy

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Saturday, April 13, 2024

Roxithromycin pregnancy category

Roxithromycin It is used to treat various bacterial infections, including respiratory tract infections such as bronchitis and pneumonia, as well as skin and soft tissue infections.

Pregnancy     Category (N/A)       ( by FDA )

                       Category  B3       (AU TGA )


  1. FDA (United States): Roxithromycin is not approved for use in the United States, so it doesn't have an assigned pregnancy category by the FDA.


  2. TGA (Australia): Roxithromycin is classified as pregnancy category B3 by the Australian Therapeutic Goods Administration (TGA). This category indicates that animal studies have shown no evidence of fetal harm, but there are no adequate and well-controlled studies in pregnant women. However, the possibility of fetal harm cannot be ruled out. Therefore, the medication should be used during pregnancy only if clearly needed.

  1. Pregnancy: Roxithromycin is typically not recommended during pregnancy unless the benefits outweigh the potential risks. It is often classified as pregnancy category B1 or B2 by some regulatory agencies, meaning that animal studies haven't shown fetal risk, but there are limited or no human studies. As with any medication during pregnancy, it's crucial to weigh the potential benefits against the potential risks, and it's best to consult with a healthcare professional for personalized advice.


  2. Lactation: Roxithromycin does pass into breast milk, although the extent of this transfer is not well established. Due to this and the lack of adequate safety data, it's generally recommended to avoid using roxithromycin during lactation if possible. If the use of roxithromycin is deemed necessary, healthcare providers may advise closely monitoring the infant for any potential adverse effects.

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