Skip to content
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.

AMBROXOL: 906 Adverse Event Reports & Safety Profile

Grow Your Own Natural Pharmacy at Home

Medicinal Garden Kit — 10 healing herbs, 4,818 seeds + step-by-step guide.

Get the Kit
906
Total FAERS Reports
55 (6.1%)
Deaths Reported
441
Hospitalizations
906
As Primary/Secondary Suspect
87
Life-Threatening
8
Disabilities

Active Ingredient: AMBROXOL HYDROCHLORIDE ·

First Report: 19940311 · Latest Report: 20250731

What Are the Most Common AMBROXOL Side Effects?

#1 Most Reported
Dyspnoea
169 reports (18.7%)
#2 Most Reported
Drug ineffective
149 reports (16.4%)
#3 Most Reported
Cough
141 reports (15.6%)

All AMBROXOL Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Dyspnoea 169 18.7% 0 55
Drug ineffective 149 16.5% 1 95
Cough 141 15.6% 0 27
Off label use 138 15.2% 2 120
Chest discomfort 134 14.8% 0 21
Nasopharyngitis 128 14.1% 0 10
Atrial fibrillation 125 13.8% 0 7
Dyspnoea exertional 122 13.5% 0 12
Dysphonia 121 13.4% 0 10
Wheezing 121 13.4% 0 7
Obstructive airways disorder 113 12.5% 0 1
Eosinophilia 111 12.3% 0 0
Myoglobin blood increased 111 12.3% 0 0
Brain natriuretic peptide increased 110 12.1% 0 0
Coronary artery disease 110 12.1% 0 0
Fractional exhaled nitric oxide increased 110 12.1% 0 0
Muscle spasms 110 12.1% 0 0
Macular degeneration 109 12.0% 0 79
Nausea 109 12.0% 1 103
Cardiac disorder 107 11.8% 0 0

Who Reports AMBROXOL Side Effects? Age & Gender Data

Gender: 53.0% female, 47.0% male. Average age: 57.8 years. Most reports from: DE. View detailed demographics →

Is AMBROXOL Getting Safer? Reports by Year

YearReportsDeathsHosp.
2000 1 0 1
2004 1 1 0
2005 10 1 10
2006 2 0 0
2010 1 0 1
2011 8 0 8
2012 2 0 2
2013 7 3 5
2014 16 1 7
2015 57 1 50
2016 44 4 30
2017 47 2 14
2018 156 1 30
2019 35 10 13
2020 57 3 13
2021 34 1 18
2022 13 1 5
2023 17 1 7
2024 38 0 23
2025 8 0 3

View full timeline →

What Is AMBROXOL Used For?

IndicationReports
Product used for unknown indication 476
Productive cough 29
Pneumonia 26
Cough 25
Sputum abnormal 23
Pain 22
Asthma 20
Chronic obstructive pulmonary disease 17
Bronchitis 16
Arthralgia 13

AMBROXOL vs Alternatives: Which Is Safer?

AMBROXOL vs AMDINOCILLIN PIVOXIL AMBROXOL vs AMG-510 AMBROXOL vs AMIFAMPRIDINE AMBROXOL vs AMIFOSTINE AMBROXOL vs AMIKACIN AMBROXOL vs AMILORIDE AMBROXOL vs AMILORIDE\HYDROCHLOROTHIAZIDE AMBROXOL vs AMINO ACIDS AMBROXOL vs AMINO ACIDS, SOURCE UNSPECIFIED AMBROXOL vs AMINO ACIDS\ANHYDROUS DEXTROSE\CALCIUM\MAGNESIUM HEPTAHYDRATE\POTASSIUM\SODIUM\SODIUM GLYCEROPHOSPHATE ANHYDROUS\SOYBEAN OIL

Official FDA Label for AMBROXOL

Official prescribing information from the FDA-approved drug label.