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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.

ACETYLLEUCINE: 174 Adverse Event Reports & Safety Profile

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174
Total FAERS Reports
8 (4.6%)
Deaths Reported
140
Hospitalizations
174
As Primary/Secondary Suspect
9
Life-Threatening

First Report: 2012 · Latest Report: 20250526

What Are the Most Common ACETYLLEUCINE Side Effects?

#1 Most Reported
Hepatitis acute
25 reports (14.4%)
#2 Most Reported
Fall
22 reports (12.6%)
#3 Most Reported
Anaemia
17 reports (9.8%)

All ACETYLLEUCINE Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Hepatitis acute 25 14.4% 0 25
Fall 22 12.6% 0 22
Anaemia 17 9.8% 0 14
Anticoagulation drug level above therapeutic 16 9.2% 0 16
Haematoma 16 9.2% 0 15
Confusional state 12 6.9% 0 12
Acute generalised exanthematous pustulosis 10 5.8% 0 10
Hepatitis 10 5.8% 0 10
Condition aggravated 9 5.2% 7 0
Eosinophilia 9 5.2% 0 3
Gastrointestinal disorder 9 5.2% 0 9
Hepatic necrosis 9 5.2% 0 9
Hyponatraemia 9 5.2% 0 9
Jaundice 9 5.2% 0 9
Sleep apnoea syndrome 9 5.2% 0 9
Thrombocytopenia 9 5.2% 7 0
Head injury 8 4.6% 0 8
Inappropriate antidiuretic hormone secretion 8 4.6% 0 8
Vomiting 8 4.6% 0 8
Hyperbilirubinaemia 7 4.0% 0 7

Who Reports ACETYLLEUCINE Side Effects? Age & Gender Data

Gender: 56.5% female, 43.5% male. Average age: 71.1 years. Most reports from: FR. View detailed demographics →

Is ACETYLLEUCINE Getting Safer? Reports by Year

YearReportsDeathsHosp.
2012 7 0 7
2013 6 1 6
2014 5 0 5
2015 2 0 2
2016 27 7 14
2017 24 0 23
2018 30 0 27
2019 24 0 21
2020 23 0 23
2021 1 0 0
2022 1 0 1
2023 11 0 8
2024 4 0 0
2025 1 0 1

View full timeline →

What Is ACETYLLEUCINE Used For?

IndicationReports
Product used for unknown indication 85
Vertigo 51
Dizziness 12

ACETYLLEUCINE vs Alternatives: Which Is Safer?

ACETYLLEUCINE vs ACETYLLEUCINE, L- ACETYLLEUCINE vs ACETYLSALICYLIC ACID ACETYLLEUCINE vs ACITRETIN ACETYLLEUCINE vs ACLARUBICIN ACETYLLEUCINE vs ACLIDINIUM ACETYLLEUCINE vs ACLIDINIUM\FORMOTEROL ACETYLLEUCINE vs ACORAMIDIS ACETYLLEUCINE vs ACTEMRA ACETYLLEUCINE vs ACTIQ ACETYLLEUCINE vs ACTIVATED CHARCOAL

Official FDA Label for ACETYLLEUCINE

Official prescribing information from the FDA-approved drug label.