May 19 2022

Classification of the active ingredient betahistine


Risk level in pregnancy: This medicine is classified as Category D.

Have not been established the safety of betahistine dihydrochloride in human pregnancy. Studies in experimental animals are insufficient to determine the possible alterations of embryonic or fetal development, or after birth. The potential risk for humans is unknown. The manufacturer recommends not using betahistine during pregnancy unless clearly necessary.

A review on the safety of drug use during pregnancy antivertigos states that betahistine is contraindicated during pregnancy [1].

References:

1. Vlastarakos PV, Nikolopoulos TP, Manolopoulos L, Ferekidis E, Kreatsas G. Treating common ear problems in pregnancy: what is safe? Eur Arch Otorhinolaryngol. 2008 Feb;265(2):139-45.

Update 13.06.2010

Meaning of category D

There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.