What is the probability of entecavir causing fetal malformations?

Nov 15, 2025 Source: Cainiu Health
Dr. Zhang Lu
Introduction
If entecavir must be used during pregnancy due to therapeutic needs (e.g., active chronic hepatitis B), the physician will decide on the treatment plan after comprehensively evaluating the patient's condition and potential risks. Clinical observations to date have not shown a significantly higher incidence of fetal malformations compared to the general population; however, regular prenatal examinations are necessary to closely monitor fetal development and promptly identify any potential abnormalities.

Entecavir is commonly available in tablet form. Currently, there is no clear data defining the exact probability of entecavir causing fetal malformations; however, animal studies have shown that the drug has certain reproductive toxicity. Therefore, its use during pregnancy is not recommended unless absolutely necessary. If there are concerns, it is advisable to consult a healthcare provider in advance. Detailed analysis is as follows:

If entecavir must be used during pregnancy due to medical necessity (e.g., active chronic hepatitis B), the physician will decide on the treatment plan after comprehensively evaluating the patient's condition and potential risks. Clinical observations to date have not shown an increased risk of fetal malformations compared to the general population; however, regular prenatal check-ups are essential to closely monitor fetal development and promptly identify any possible abnormalities.

If entecavir is not essential during pregnancy or if the condition can be managed with safer alternative medications, physicians typically recommend switching drugs or adjusting the treatment plan. Avoiding non-essential use of entecavir minimizes potential drug exposure to the fetus, reduces unnecessary health risks, and provides a safer environment for fetal development.

If a patient plans to conceive or experiences an unintended pregnancy while taking entecavir, she should immediately inform her doctor and must not discontinue or adjust the dosage on her own. The physician will develop an appropriate management plan based on individual circumstances, balancing maternal treatment needs with fetal safety, and conduct regular prenatal monitoring to ensure the health of both mother and baby.

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