Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Betahistine
Drug ID BADD_D00258
Description 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.[A220318,L16408] 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through its actions on histamine receptors.[A220333,L16403] Betahistine was first approved by the FDA in the 1970s but withdrawn within approximately 5 years due to a lack of evidence supporting its efficacy.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.
Indications and Usage Betahistine is indicated for the reduction of recurrent vertigo episodes associated with Ménière's disease in patients 18 years old and above.[L16388]
Marketing Status approved; investigational
ATC Code N07CA01
DrugBank ID DB06698
KEGG ID D07522
MeSH ID D001621
PubChem ID 2366
TTD Drug ID D0XW9U
NDC Product Code Not Available
UNII X32KK4201D
Synonyms Betahistine | Aequamen | Betahistin-Ratiopharm | Betahistin Ratiopharm | Betahistine Dihydrobromide | Dihydrobromide, Betahistine | Betahistine Hydrochloride | Hydrochloride, Betahistine | Betahistine Dihydrochloride | Dihydrochloride, Betahistine | Betahistine Mesylate | Mesylate, Betahistine | Betahistine Methanesulphonate | Methanesulphonate, Betahistine | Betahistine Methanesulfonate | Methanesulfonate, Betahistine | Betavert | By-Vertin | By Vertin | Extovyl | Fidium | Lectil | Melopat | Mersilon | PT-9 | PT 9 | PT9 | Ribrain | Serc | Betaserc | Vasomotal | Betahistine Biphar | Vertigon | Betahistin AL | Betahistin Stada
Chemical Information
Molecular Formula C8H12N2
CAS Registry Number 5638-76-6
SMILES CNCCC1=CC=CC=N1
Chemical Structure
ADRs Induced by Drug
*The priority for ADR severity classification is based on FAERS assessment, followed by the most severe level in CTCAE rating. If neither is available, it will be displayed as 'Not available'.
**The 'Not Available' level is hidden by default and can be restored by clicking on the legend twice.
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Abdominal discomfort07.01.06.001---
Abdominal distension07.01.04.001--
Abdominal pain upper07.01.05.003--
Anaphylactic shock10.01.07.002; 24.06.02.004---
Angioedema10.01.05.009; 22.04.02.008; 23.04.01.001---
Asthenia08.01.01.001---
Asthma10.01.03.010; 22.03.01.002---
Bronchospasm10.01.03.012; 22.03.01.004--
Condition aggravated08.01.03.004---
Confusional state17.02.03.005; 19.13.01.001--
Dermatitis23.03.04.002---
Dermatitis allergic10.01.03.014; 23.03.04.003---
Dermatitis atopic10.01.04.004; 23.03.04.016---
Diarrhoea07.02.01.001--
Discomfort08.01.08.003---
Dizziness02.11.04.006; 17.02.05.003; 24.06.02.007--
Drug ineffective08.06.01.006---
Dyspepsia07.01.02.001--
Dyspnoea02.11.05.003; 22.02.01.004--
Erythema23.03.06.001---
Erythema multiforme10.01.03.015; 23.03.01.003--
Fatigue08.01.01.002--
Feeling abnormal08.01.09.014---
Feeling hot08.01.09.009---
Flatulence07.01.04.002--
Gastrointestinal disorder07.11.01.001---
Hallucination19.10.04.003--
Headache17.14.01.001--
Hypersensitivity10.01.03.003--
Hypoaesthesia17.02.06.023; 23.03.03.081---
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