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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.

BENZYDAMINE: 345 Adverse Event Reports & Safety Profile

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345
Total FAERS Reports
50 (14.5%)
Deaths Reported
246
Hospitalizations
345
As Primary/Secondary Suspect
17
Life-Threatening
4
Disabilities

Active Ingredient: BENZYDAMINE HYDROCHLORIDE ·

First Report: 200706 · Latest Report: 20240414

What Are the Most Common BENZYDAMINE Side Effects?

#1 Most Reported
Drug ineffective
232 reports (67.2%)
#2 Most Reported
Macular degeneration
210 reports (60.9%)
#3 Most Reported
Nausea
196 reports (56.8%)

All BENZYDAMINE Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Drug ineffective 232 67.3% 3 158
Macular degeneration 210 60.9% 0 145
Nausea 196 56.8% 44 196
Constipation 169 49.0% 32 165
Anaemia 165 47.8% 32 165
Headache 164 47.5% 32 164
Off label use 162 47.0% 16 161
Pyrexia 144 41.7% 1 139
Therapeutic product effect incomplete 142 41.2% 0 142
Chronic sinusitis 140 40.6% 0 140
Malaise 139 40.3% 0 139
Pain 139 40.3% 0 139
Paraesthesia oral 139 40.3% 0 139
Weight decreased 139 40.3% 0 139
Erythema 133 38.6% 0 133
Abdominal pain 130 37.7% 0 130
Female genital tract fistula 130 37.7% 0 130
Colitis 129 37.4% 0 129
Frequent bowel movements 129 37.4% 0 129
Haematochezia 129 37.4% 0 129

Who Reports BENZYDAMINE Side Effects? Age & Gender Data

Gender: 91.6% female, 8.4% male. Average age: 59.0 years. Most reports from: CA. View detailed demographics →

Is BENZYDAMINE Getting Safer? Reports by Year

YearReportsDeathsHosp.
2007 2 0 2
2013 1 0 1
2014 10 0 3
2015 11 0 11
2016 11 10 10
2017 1 1 1
2018 13 0 10
2019 5 1 2
2020 38 35 38
2021 3 0 1
2022 6 0 6
2023 2 0 1
2024 3 0 3

View full timeline →

What Is BENZYDAMINE Used For?

IndicationReports
Product used for unknown indication 234
Prophylaxis 42
Toothache 16
Mucosal inflammation 13
Oropharyngeal pain 12

BENZYDAMINE vs Alternatives: Which Is Safer?

BENZYDAMINE vs BENZYL ALCOHOL\ETANERCEPT BENZYDAMINE vs BEPOTASTINE BESILATE BENZYDAMINE vs BERACTANT BENZYDAMINE vs BERAPROST BENZYDAMINE vs BEROTRALSTAT BENZYDAMINE vs BESIFLOXACIN BENZYDAMINE vs BETA CAROTENE BENZYDAMINE vs BETA GLUCAN BENZYDAMINE vs BETAHISTINE BENZYDAMINE vs BETAINE

Official FDA Label for BENZYDAMINE

Official prescribing information from the FDA-approved drug label.