Clotrimazole is an imidazole antimycotic agent widely used topically and intravaginally to treat candida infections during pregnancy. Topical treatment with clotrimazole is not expected to lead to significant systemic exposure.
There is no evidence that use of clotrimazole during pregnancy is associated with an increased overall risk of congenital malformation or of any specific malformations. Data regarding miscarriage risk are also reassuring. The majority of evidence suggests that use of clotrimazole during pregnancy significantly reduces the incidence of preterm birth (and associated low birth weight) in women with candida infection.
There are no published data regarding clotrimazole and neurodevelopmental outcomes, carcinogenicity or neonatal complications in exposed offspring.
The manufacturers of clotrimazole state that intravaginal clotrimazole preparations may be used in pregnancy if required. Pregnant women may need a longer duration of treatment (usually about 7 days) to clear the infection.
Exposure to clotrimazole at any stage in pregnancy would not usually be regarded as medical grounds for termination of pregnancy or any additional fetal monitoring. However, other risk factors may be present in individual cases which may independently increase the risk of adverse pregnancy outcome. Clinicians are reminded of the importance of consideration of such factors when performing case-specific risk assessments.
This is a summary of the full UKTIS monograph for health care professionals and should not be used in isolation. The full UKTIS monograph and access to any hyperlinked related documents is available to NHS health care professionals who are logged in.
If you have a patient with exposure to a drug or chemical and require assistance in making a patient-specific risk assessment, please telephone UKTIS on 0344 892 0909 to discuss the case with a teratology specialist.
If you would like to report a pregnancy to UKTIS please click here to download our pregnancy reporting form. Please encourage all women to complete an online reporting form.