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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.

BROMHEXINE: 264 Adverse Event Reports & Safety Profile

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264
Total FAERS Reports
31 (11.7%)
Deaths Reported
165
Hospitalizations
264
As Primary/Secondary Suspect
20
Life-Threatening
15
Disabilities

Active Ingredient: BROMHEXINE HYDROCHLORIDE ·

First Report: 19931208 · Latest Report: 20250809

What Are the Most Common BROMHEXINE Side Effects?

#1 Most Reported
Off label use
82 reports (31.1%)
#2 Most Reported
Somnolence
64 reports (24.2%)
#3 Most Reported
Gastrooesophageal reflux disease
55 reports (20.8%)

All BROMHEXINE Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Off label use 82 31.1% 15 63
Somnolence 64 24.2% 1 55
Gastrooesophageal reflux disease 55 20.8% 0 54
Coma 54 20.5% 0 54
Pneumonia aspiration 54 20.5% 0 54
Pyrexia 51 19.3% 5 40
Chronic sinusitis 45 17.1% 0 45
Nausea 44 16.7% 0 38
Drug ineffective 42 15.9% 0 38
Underdose 39 14.8% 0 39
Constipation 38 14.4% 5 33
Erythema 38 14.4% 0 33
Dyspepsia 36 13.6% 0 36
Paraesthesia oral 36 13.6% 0 36
Therapeutic product effect incomplete 36 13.6% 0 36
Weight decreased 36 13.6% 0 36
Headache 35 13.3% 0 34
Infusion related reaction 35 13.3% 0 35
Malaise 35 13.3% 0 34
Anaemia 34 12.9% 0 34

Who Reports BROMHEXINE Side Effects? Age & Gender Data

Gender: 63.8% female, 36.2% male. Average age: 58.6 years. Most reports from: CA. View detailed demographics →

Is BROMHEXINE Getting Safer? Reports by Year

YearReportsDeathsHosp.
2009 1 0 1
2013 4 1 1
2014 3 0 3
2015 5 0 5
2016 8 1 4
2017 6 0 3
2018 7 0 3
2019 2 0 1
2020 23 19 7
2021 13 0 12
2022 1 0 0
2023 5 0 3
2024 4 0 3
2025 4 0 0

View full timeline →

What Is BROMHEXINE Used For?

IndicationReports
Product used for unknown indication 169
Cough 17
Productive cough 10
Covid-19 6

BROMHEXINE vs Alternatives: Which Is Safer?

BROMHEXINE vs BROMOCRIPTINE BROMHEXINE vs BROTIZOLAM BROMHEXINE vs BUCILLAMINE BROMHEXINE vs BUDESONIDE BROMHEXINE vs BUDESONIDE\FORMOTEROL BROMHEXINE vs BUDESONIDE\FORMOTEROL\GLYCOPYRROLATE BROMHEXINE vs BUDESONIDE\FORMOTEROL\GLYCOPYRRONIUM BROMHEXINE vs BUMETANIDE BROMHEXINE vs BUPIVACAINE BROMHEXINE vs BUPIVACAINE\BUPIVACAINE ANHYDROUS

Official FDA Label for BROMHEXINE

Official prescribing information from the FDA-approved drug label.