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Histamine Analogue — Vertigo / Ménière's Disease Pregnancy: There are no adequate data from the use of betahistine in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity, embryonal/foetal development, parturition and postnatal development at clinically relevant therapeutic exposure. As a precautionary measure, it is preferable to avoid the use of betahistine during pregnancy. It is not known whether betahistine is excreted in human milk (it is excreted in rat milk) - the importance of the drug to the mother should be weighed against the benefits of nursing and the potential risks for the child.

Betahistine

Brand names: Serc

Betahistine is an oral histamine analogue used to reduce the frequency and severity of vertigo, tinnitus and hearing loss in Ménière's disease.

Auto-extracted from the source labelling — not yet independently clinician-verified. These values were distilled from the UK SPC (or the US label where noted) but have not had a clinician sign-off. Confirm against the current SmPC before prescribing.

Adult dose

Dose: Initial oral treatment 8 to 16 mg three times daily; maintenance doses are generally in the range 24-48 mg daily
Route: Oral - take the tablets preferably with meals, or after meals with a glass of water (taking betahistine with food may help relieve the mild indigestion it can cause)
Frequency: Three times daily initially; the maintenance daily dose should be given in 2 or 3 divided doses throughout the day
Max: Daily dose should not exceed 48 mg
PRODUCT: Betahistine 16 mg tablets (UK SPC). BY STRENGTH: 8 mg tablets - 1 to 2 tablets three times a day; 16 mg tablets - half to 1 tablet three times a day; 24 mg tablets - recommended starting dose 24 mg, and if the maximum daily dose of 48 mg is indicated adults take one 24 mg tablet twice daily (morning and evening). Dosage can be adjusted to suit individual patient needs. RESPONSE: improvement could sometimes be observed only after a couple of weeks of treatment, and the best results are sometimes obtained after a few months; there are indications that treatment from the onset of the disease prevents progression of the disease and/or the loss of hearing in later phases. RENAL AND HEPATIC IMPAIRMENT: no specific clinical trials are available, but according to post-marketing experience no dose adjustment appears to be necessary. ELDERLY: although data from clinical studies are limited, extensive post-marketing experience suggests no dose adjustment is necessary. PAEDIATRIC: betahistine tablets are not recommended for use in children and adolescents below age 18 due to lack of data on safety and efficacy. NOT APPROPRIATE for benign paroxysmal vertigo or for dizziness related to central nervous system disease.

Dose adjustments

Renal

There are no specific clinical trials available in patients with renal impairment, but according to post-marketing experience no dose adjustment appears to be necessary.

Dose auto-extracted from UK Summary of Product Characteristics (SPC) via the eMC — not yet clinician-verified. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

  • Hypersensitivity to the active substance or to any of the excipients
  • Phaeochromocytoma - as betahistine is a synthetic analogue of histamine it may induce the release of catecholamines from the tumour, resulting in severe hypertension

Side effects

  • Headache (common)
  • Nausea and dyspepsia (common)
  • Mild gastric complaints - vomiting, gastrointestinal pain, dry mouth, diarrhoea, abdominal distension and bloating (frequency not known); these can normally be dealt with by taking the dose during meals or by lowering the dose
  • Cutaneous and subcutaneous hypersensitivity reactions, in particular angioneurotic oedema, urticaria, rash and pruritus (frequency not known)
  • Hypersensitivity reactions, e.g. anaphylaxis (frequency not known)
  • Thrombocytopenia (frequency not known)

Interactions

  • There are no proven cases of hazardous interactions; no in-vivo interaction studies have been performed, and based on in-vitro data no in-vivo inhibition of cytochrome P450 enzymes is expected
  • Monoamine oxidase (MAO) inhibitors, including MAO subtype B selective agents such as selegiline - in vitro data indicate inhibition of betahistine metabolism; caution is recommended with concomitant use
  • H1 antagonists (antihistamines) - betahistine is a histamine analogue, so concurrent administration may cause a mutual attenuation of the effect of the active agents
  • Case reports exist of an interaction with ethanol and with a compound containing pyrimethamine with dapsone, and of potentiation of betahistine with salbutamol

Clinical monograph

How it works

It acts as a weak histamine H1-receptor agonist and a more potent H3-receptor antagonist, increasing inner-ear microcirculation and modulating vestibular nucleus activity.

Prescribing in practice

  • Avoid in phaeochromocytoma and use with caution in asthma and active or historic peptic ulcer disease, as histaminergic activity may worsen these conditions.
  • Theoretically antagonised by antihistamines, so review concurrent sedating antihistamine use that could blunt efficacy.
  • Take with or after food to reduce gastric upset; clinical benefit may take several weeks to become apparent.

Monitoring

No routine laboratory monitoring is required; assess response by frequency and severity of vertigo attacks and review periodically.

Counselling the patient

  • Take doses with food and continue regularly even if symptoms fluctuate.
  • Report worsening wheeze, indigestion or abdominal pain.
  • Benefit on vertigo may build gradually over weeks rather than immediately.

Evidence & guidelines

Betahistine is an established symptomatic treatment for Ménière's disease, though trial evidence for its efficacy remains modest and somewhat mixed.

Reference: NICE CKS Ménière's Disease; Cochrane Review (Betahistine for Ménière's disease 2016); Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Related

Curated clinical cross-links plus same-class fallbacks.