[4][5] Betahistine was once believed to have some positive effects in the treatment of Ménière's disease and vertigo,[3] but more recent evidence casts doubt on its efficacy.

[4][5] Studies of the use of betahistine have shown a reduction in symptoms of vertigo and, to a lesser extent, tinnitus, but conclusive evidence is lacking at present.

Oral betahistine has been approved for the treatment of Ménière's disease and vestibular vertigo in more than 80 countries worldwide, and has been reportedly prescribed for more than 130 million patients.

Any adverse effects that persist or outweigh the relief of symptoms of the original condition may warrant that the patient consult their physician to adjust or change the medication.

Betahistine primarily acts on histamine H₁ receptors located on blood vessels in the inner ear, leading to vasodilation and increased vascular permeability.

By modulating H₃ receptors, betahistine increases the release of various neurotransmitters, including histamine, acetylcholine, norepinephrine, serotonin, and GABA from nerve endings.

[citation needed] Betahistine is marketed under a number of brand names, including Veserc, Serc, Hiserk, Betaserc, and Vergo.

[1] Betahistine, marketed as Serc, received initial approval from the US Food and Drug Administration (FDA) in November 1966 for the treatment of Ménière's disease.

This approval was based on a single clinical study conducted by Joseph Elia and published in the Journal of the American Medical Association (JAMA) in April of that year.

This decision not to immediately remove betahistine from the market drew congressional scrutiny, particularly from Representative Lawrence Fountain, who cited the Food, Drug, and Cosmetic Act's mandate for withdrawal when substantial evidence of efficacy is lacking.

[14] Unimed's attempted legal challenge to maintain the drug's market presence was also unsuccessful, with the US Court of Appeals for the Second Circuit upholding the FDA's withdrawal.