Evigrade

Betahistine

AEMPS

Histamine analogue, antivertigo agent

ATC code: N07CA01

Updated · Methodology

Indications

C

Meniere's disease

First line

First-line for Meniere's disease to reduce vertigo attack frequency per EAONO/JOS 2015 and -HNS 2020. Standard dose 16 mg three times daily or 24 mg twice daily for 6–12 months. Evidence is conflicting: BEMED 2016 (221 patients) showed no benefit over placebo at 48 mg or 144 mg/day over 9 months. retained registration on historical data; has not approved it in the US.

ICD-10: H81.0 · ICD-11: AB31.0

Marketing claims without evidence base

The drug is promoted for these uses outside international guidelines. Each entry below is analyzed against AEMPS, FDA, EMA, Cochrane and major RCTs.

F

Memory and concentration enhancement

Not recommended

Betahistine is a histamine analogue prescribed for Meniere's disease and peripheral vestibular vertigo ( 2017 guidelines and AEMPS Ficha Técnica). Evidence quality for Meniere's disease is modest: the Cochrane review by Murdin 2016 found low-quality evidence. For cerebral circulation improvement or cognitive decline in older adults, betahistine is not used: no clinical studies of such use exist. Vascular cognitive dysfunction is managed not by vasodilators but by blood-pressure control, lipid management, smoking cessation, physical activity, and cognitive training. If betahistine was prescribed for memory improvement or brain circulation, consider seeking a second opinion.

How to read tiers A–F
  • AStrong evidence – first or second line in international guidelines
  • BRecommended in selected cases
  • CStudy data contradict each other
  • DBenefit not proven, no documented harm
  • FDocumented harm, or risk without benefit

Mechanism of action

A weak H1-receptor agonist and strong H3-receptor antagonist in the CNS. Proposed mechanism: improved inner-ear microcirculation and reduced endolymph pressure via stria vascularis vasodilation. Metabolized to inactive 2-pyridylacetic acid. Half-life 3–4 hours, dosed 2–3 times daily. -approved for Meniere's disease; has not approved it in the US.

Safety

Contraindications

  • Betahistine hypersensitivity
  • Pheochromocytoma
  • Active peptic ulcer
  • Severe asthma (theoretical risk, rare in practice)
  • Age under 18

Serious adverse effects

  • Allergic reactions, angioedema (rare)
  • Peptic ulcer exacerbation

Common adverse effects

  • Nausea, dyspepsia
  • Headache
  • Warmth or flushing

Pregnancy: can you take Betahistine?

Limited pregnancy data. Use is not recommended.

Breastfeeding: can you take Betahistine?

No data. Not used during lactation.

Reference information, not a clinical decision. Discuss feeding pauses or changes with your physician or an IBCLC.

Practical notes

Timing and administration

Take with food to reduce GI side effects. Effect on attack frequency develops over 2–3 months, so courses under 3 months are uninformative. Reassess continuation after 12 months. With persistent attacks despite adequate therapy, intratympanic steroids or gentamicin are considered.
Label mentions2 mentions

Verbatim lines from the interaction sections, in the language of the label

From this drug’s label

  • antihistamínicosclass named in the label
    «Como la betahistina es un análogo de la histamina, la interacción de betahistina con antihistamínicos puede en teoría afectar la eficacia de uno de estos medicamentos.»

    AEMPS, section 4.5 · Open on CIMA

From other drugs’ labels

  • «Betahistina y fármacos anticolinesterásicos: Hidroxizina antagoniza los efectos de la betahistina y de los fármacos anticolinesterásicos»

    AEMPS, section 4.5 · Open on CIMA

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Frequently asked

What is Betahistine used for?

Betahistine is evaluated for the following indications with varying evidence strength: Meniere's disease (evidence tier C), Vertigo (evidence tier C), Memory and concentration enhancement (evidence tier F). See the full indication matrix with dosing and citations above on this page.

What are the side effects of Betahistine?

Common side effects of Betahistine (≥ 1 in 100): Nausea, dyspepsia, Headache, Warmth or flushing. See the Safety section for uncommon and serious reactions.

Is Betahistine safe during pregnancy?

Limited pregnancy data. Use is not recommended.

Is Betahistine compatible with breastfeeding?

No data. Not used during lactation.

Who should not take Betahistine?

Betahistine is contraindicated in: Betahistine hypersensitivity; Pheochromocytoma; Active peptic ulcer; Severe asthma (theoretical risk, rare in practice); Age under 18. Full list in the Safety section.

Official sources

Direct links to regulator labels. Open in a new tab.

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