Betahistine

Overview

Ménière's disease is a progressive disease of the inner ear characterized by vertigo, tinnitus, and hearing loss. It has a significant impact on both the physical and social functioning of affected individuals. Betahistine is a histamine-like antivertigo drug used for treating symptoms associated with Ménière's disease. It is thought to reduce symptoms through its actions on histamine receptors. Betahistine was first approved by the FDA in the 1970s but withdrawn within approximately 5 years due to a lack of evidence supporting its efficacy. It is currently marketed in Canada by various companies, including Teva Pharmaceuticals.

Indication

Betahistine is indicated for the reduction of recurrent vertigo episodes associated with Ménière's disease in patients 18 years old and above.

Associated Conditions

Menière's Disease

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Comparing Oral Lumbrokinase DLBS1033 and Betahistine Mesylate in Benign Paroxysmal Positional Vertigo	2025/07/20	NCT07075289	Not Applicable	Completed	Universitas Sebelas Maret
Transcutaneous Auricular Vagus Nerve Stimulation for Meniere Disease	2024/08/09	NCT06544590	N/A	Completed	Beijing Tongren Hospital
Laser Acupuncture for Meniere Disease	2024/08/09	NCT06544434	Phase 2	Recruiting	Beijing Tongren Hospital
Modulating Auditory Symptoms and Vertigo of Meniere's Disease by Non-invasive Mastoid Electric Stimulation	2023/08/21	NCT06001593	Phase 1	Recruiting	Seoul National University Hospital
Pharmacokinetic Profile of Betahistine With and Without Selegiline in Healthy Volunteers	2023/07/10	NCT05938517	Phase 1	Completed	Ludwig-Maximilians - University of Munich
Safety and Efficacy of Shi's Traumatology Osteopathic Manipulative Treatment for Cervicogenic Dizziness	2022/11/03	NCT05604937	Not Applicable	Completed	Zhan Yunfan
Interventions for Residual Dizziness After Successful Repositioning Maneuvers in Patients With BPPV	2018/08/10	NCT03624283	Not Applicable	UNKNOWN	Eye & ENT Hospital of Fudan University
The CBF Study Evaluating the Effect of Betahistine on the Cerebral Blood Flow	2011/11/09	NCT01468285	Phase 4	Completed	Abbott Products
Evaluation of Co-Administration of Betahistine as Adjunctive to Olanzapine in Healthy Subjects	2010/07/23	NCT01168336	Phase 1	Completed	OBEcure Ltd.
Evaluation of Safety, Drug-Drug Interactions and Pharmacokinetic Profiles of Co-Administration of Betahistine With Olanzapine in Healthy Female Subjects	2009/02/27	NCT00852956	Phase 1	Completed	OBEcure Ltd.

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
No FDA approvals found for this drug.

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
BETASERC 24 TABLET 24 mg	Mylan Laboratories SAS	SIN12235P	TABLET	24 mg	3/24/2003
MERISLON TABLET 6 mg	EISAI CO LTD (KAWASHIMA PLANT)	SIN03047P	TABLET	6 mg	6/7/1989
GP-BETAHISTINE TABLETS 24MG	CELOGEN GENERICS PRIVATE LTD	SIN16812P	TABLET	24mg	6/21/2023
BETASERC TABLETS 16 mg	Mylan Laboratories SAS	SIN11365P	TABLET	16 mg	8/2/2000

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
MERISLON TAB 6MG	N/A	EISAI (HONG KONG) COMPANY LIMITED	N/A	N/A	10/23/2001

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
BETAHISTINE LUPIN betahistine dihydrochloride 16mg tablet blister pack	388870	Southern Cross Pharma Pty Ltd	Medicine	A	10/13/2022
APO-BETAHISTINE betahistine dihydrochloride 16 mg uncoated tablet blister pack	217105	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	10/20/2014
BETAHISTINE GH betahistine dihydrochloride 16 mg tablets blister packs	212076	Generic Health Pty Ltd	Medicine	A	8/14/2014
BETAHISTINE-WGR betahistine dihydrochloride 16 mg tablets blister packs	212078	GM Pharma International Pty Ltd	Medicine	A	8/14/2014
SETEAR betahistine dihydrochloride 24 mg tablet blister pack	261439	Southern XP IP Pty Ltd	Medicine	A	3/2/2017
BETISTAVERT betahistine dihydrochloride 16 mg tablets blister packs	212087	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	8/14/2014
BEHISTATINE betahistine dihydrochloride 16 mg tablets blister packs	212084	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	8/14/2014
BETAHISTINE GPPL betahistine dihydrochloride 16 mg tablets blister packs	212085	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	8/14/2014
BETASERT betahistine dihydrochloride 16 mg tablets blister packs	212080	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	8/14/2014
SERBEHIST betahistine dihydrochloride 16 mg tablets blister packs	212086	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	8/14/2014

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
AURO-BETAHISTINE	auro pharma inc	02449145	Tablet - Oral	8 MG	11/30/2015
M-BETAHISTINE	mantra pharma inc	02519690	Tablet - Oral	16 MG	7/25/2022
AURO-BETAHISTINE	auro pharma inc	02449161	Tablet - Oral	24 MG	11/30/2015
APO-BETAHISTINE	Apotex Inc	02427982	Tablet - Oral	24 MG	N/A
ACT BETAHISTINE	actavis pharma company	02374765	Tablet - Oral	24 MG	10/13/2011
TEVA-BETAHISTINE	teva canada limited	02280191	Tablet - Oral	16 MG	8/14/2006
SERC - TAB 4MG	solvay pharma inc	02222035	Tablet - Oral	4 MG / TAB	8/13/1997
MINT-BETAHISTINE	mint pharmaceuticals inc	02538121	Tablet - Oral	8 MG	10/20/2023
TEVA-BETAHISTINE	teva canada limited	02280205	Tablet - Oral	24 MG	8/30/2006
MINT-BETAHISTINE	mint pharmaceuticals inc	02538156	Tablet - Oral	24 MG	10/31/2023

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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