Betahistine Safety in Pregnancy
Betahistine is contraindicated during pregnancy and should be avoided. 1
Evidence-Based Recommendation
The available evidence consistently advises against betahistine use in pregnant women:
Betahistine is explicitly contraindicated in pregnancy according to a comprehensive review of ear disease treatments during pregnancy published in the European Archives of Oto-Rhino-Laryngology. 1
The FDA drug label for histamine (the parent compound) states that histamine should only be used during pregnancy if clearly needed, and exposure or repeated doses should be avoided due to its known ability to contract uterine muscle, which poses theoretical risk to the pregnancy. 2
The FDA classifies histamine as Pregnancy Category C, meaning animal studies have shown adverse effects or are unavailable, and there are no adequate well-controlled studies in pregnant women. 2
Limited Human Safety Data
The human experience with betahistine in pregnancy is extremely limited:
A 2018 case series from Turkey reported outcomes of only 27 pregnant women exposed to betahistine—the largest published series to date. Among 20 live births with known malformation details, there were 17 normal outcomes, one major malformation, and two minor malformations. 3
This case series is insufficient to establish safety, as acknowledged by the authors themselves, who noted the need for larger epidemiological studies with control groups. 3
The small sample size, lack of control group, and absence of systematic follow-up make it impossible to draw definitive conclusions about teratogenic risk. 4
Mechanism of Concern
The contraindication is based on pharmacological principles:
Betahistine is a histamine analogue with histamine H1 receptor agonist activity. 5
Histamine has documented ability to contract uterine smooth muscle, which could theoretically trigger preterm labor or miscarriage. 2
This mechanism-based concern exists even in the absence of large-scale human outcome data. 2
Clinical Management Approach
For pregnant women with vestibular disorders (Ménière's disease, vertigo):
First-line alternatives for vertigo/nausea: Meclizine or dimenhydrinate are considered relatively safe antiemetics for vertigo attacks during pregnancy. 1
Alternative antiemetics: Metoclopramide, vitamin B6, and ginger rhizome can be used. 1
Severe Ménière's disease: Low-dose diazepam and diuretics may be considered with caution in selected severe cases only. 1
Systemic corticosteroids (prednisone, prednisolone) can be considered in selected cases when benefits clearly outweigh risks. 1
Important Caveats
If a woman has inadvertently taken betahistine in early pregnancy before knowing she was pregnant, the limited case series data suggest most pregnancies resulted in normal outcomes, though this should not be interpreted as proof of safety. 3
The risk-benefit calculation changes in life-threatening maternal conditions, but vestibular disorders rarely meet this threshold. 6
Betahistine has an excellent postmarketing safety profile in non-pregnant populations (>130 million patients exposed since 1968), with predominantly mild, self-limiting adverse effects. 7