From the FDA Drug Label
Pregnancy Category B Reproduction studies using oxybutynin chloride in the hamster, rabbit, rat, and mouse have shown no definite evidence of impaired fertility or harm to the animal fetus. The safety of oxybutynin chloride administered to women who are or who may become pregnant has not been established Therefore, oxybutynin chloride should not be given to pregnant women unless, in the judgment of the physician, the probable clinical benefits outweigh the possible hazards.
Oxybutynin use in pregnancy should be approached with caution. The drug is classified as Pregnancy Category B, and while animal studies have shown no evidence of impaired fertility or harm to the fetus, there is no established safety for use in pregnant women. Ditropan (oxybutynin) should only be given to pregnant women if the probable clinical benefits outweigh the possible hazards, as determined by a physician 1.
From the Research
Ditropan (oxybutynin) should be used during pregnancy only if clearly needed and when the potential benefits outweigh the risks. It is classified as FDA pregnancy category B, meaning animal studies have not shown harm to the fetus, but there are limited well-controlled studies in pregnant women. If you have overactive bladder symptoms during pregnancy, discuss with your healthcare provider about whether Ditropan is appropriate for your situation. They may first recommend non-medication approaches such as pelvic floor exercises, bladder training, and limiting caffeine intake. If medication becomes necessary, your doctor will prescribe the lowest effective dose for the shortest duration possible. The main concern with Ditropan during pregnancy is that it crosses the placenta and has anticholinergic properties that could theoretically affect the developing fetus, though specific risks are not well-documented. Always inform your obstetrician about all medications you're taking, including Ditropan, to ensure proper monitoring throughout your pregnancy.
Some key points to consider:
- The use of anticholinergic medications, such as oxybutynin, has been associated with an increased risk of dementia in some studies 2.
- However, the evidence regarding the use of oxybutynin during pregnancy is limited, and the potential risks and benefits must be carefully weighed by a healthcare provider.
- Non-medication approaches, such as pelvic floor exercises and bladder training, may be recommended as a first-line treatment for overactive bladder symptoms during pregnancy.
- If medication is necessary, the lowest effective dose and shortest duration of treatment should be used to minimize potential risks to the fetus.
It's essential to note that the most recent and highest-quality study on this topic is from 2025 2, which highlights the importance of carefully considering the potential risks and benefits of oxybutynin use during pregnancy. However, this study focused on the risk of incident dementia associated with anticholinergic medications, rather than the specific use of oxybutynin during pregnancy. Therefore, the decision to use Ditropan during pregnancy should be made on a case-by-case basis, taking into account the individual patient's needs and medical history.