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Important: This site presents data from the FDA Adverse Event Reporting System (FAERS). A report does not mean the drug caused the event. Full disclaimer.

BETAHISTINE: 681 Adverse Event Reports & Safety Profile

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681
Total FAERS Reports
34 (5.0%)
Deaths Reported
391
Hospitalizations
681
As Primary/Secondary Suspect
40
Life-Threatening
28
Disabilities

First Report: 19980321 · Latest Report: 20250315

What Are the Most Common BETAHISTINE Side Effects?

#1 Most Reported
Dizziness
121 reports (17.8%)
#2 Most Reported
Hypotension
102 reports (15.0%)
#3 Most Reported
Fall
100 reports (14.7%)

All BETAHISTINE Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Dizziness 121 17.8% 0 73
Hypotension 102 15.0% 0 38
Fall 100 14.7% 0 44
Nausea 96 14.1% 9 44
Vomiting 81 11.9% 0 39
Drug ineffective 80 11.8% 0 35
Hypersensitivity 67 9.8% 0 3
Constipation 60 8.8% 0 21
Hyponatraemia 59 8.7% 0 46
Vertigo 56 8.2% 0 14
Decreased appetite 52 7.6% 0 12
Condition aggravated 49 7.2% 0 7
Tachycardia 49 7.2% 0 17
Fatigue 48 7.1% 0 3
Asthenia 46 6.8% 0 17
Dry mouth 46 6.8% 0 1
Drug interaction 45 6.6% 0 37
Eye pruritus 44 6.5% 0 5
Atrial fibrillation 43 6.3% 1 9
Off label use 43 6.3% 0 27

Who Reports BETAHISTINE Side Effects? Age & Gender Data

Gender: 78.4% female, 21.6% male. Average age: 70.6 years. Most reports from: CA. View detailed demographics →

Is BETAHISTINE Getting Safer? Reports by Year

YearReportsDeathsHosp.
2005 3 0 3
2009 27 2 27
2010 4 0 1
2011 10 0 10
2012 16 0 1
2013 11 0 11
2014 18 2 8
2015 19 4 14
2016 35 0 29
2017 29 0 23
2018 42 1 22
2019 23 0 14
2020 34 1 24
2021 53 0 33
2022 32 9 16
2023 27 8 13
2024 24 0 21
2025 10 0 10

View full timeline →

What Is BETAHISTINE Used For?

IndicationReports
Product used for unknown indication 370
Vertigo 111
Dizziness 33
Meniere's disease 13
Balance disorder 12
Ear disorder 12
Labyrinthitis 12
Hypertension 11
Persistent postural-perceptual dizziness 9
Depression 7

BETAHISTINE vs Alternatives: Which Is Safer?

BETAHISTINE vs BETAINE BETAHISTINE vs BETAMETHASONE BETAHISTINE vs BETAMETHASONE DIPROPIONATE BETAHISTINE vs BETAMETHASONE DIPROPIONATE\BETAMETHASONE BETAHISTINE vs BETAMETHASONE DIPROPIONATE\CALCIPOTRIENE BETAHISTINE vs BETAMETHASONE DIPROPIONATE\CALCIPOTRIENE HYDRATE BETAHISTINE vs BETAMETHASONE DIPROPIONATE\CALCIPOTRIENE\CALCIPOTRIENE HYDRATE BETAHISTINE vs BETAMETHASONE DIPROPIONATE\CLOTRIMAZOLE BETAHISTINE vs BETAMETHASONE\BETAMETHASONE BETAHISTINE vs BETAMETHASONE\BETAMETHASONE DIPROPIONATE

Official FDA Label for BETAHISTINE

Official prescribing information from the FDA-approved drug label.