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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, L-: 149 Adverse Event Reports & Safety Profile

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149
Total FAERS Reports
13 (8.7%)
Deaths Reported
47
Hospitalizations
149
As Primary/Secondary Suspect
36
Life-Threatening
1
Disabilities

First Report: 20071211 · Latest Report: 20250424

What Are the Most Common ACETYLLEUCINE, L- Side Effects?

#1 Most Reported
Off label use
43 reports (28.9%)
#2 Most Reported
Renal failure
13 reports (8.7%)
#3 Most Reported
Death
10 reports (6.7%)

All ACETYLLEUCINE, L- Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Off label use 43 28.9% 0 1
Renal failure 13 8.7% 0 4
Autoimmune haemolytic anaemia 10 6.7% 0 10
Death 10 6.7% 10 0
Hypoglycaemia 9 6.0% 0 0
Interstitial lung disease 9 6.0% 0 0
Ischaemic stroke 9 6.0% 0 9
Lactic acidosis 9 6.0% 0 0
Oxygen saturation decreased 9 6.0% 0 8
Pulmonary embolism 9 6.0% 0 1
Miosis 8 5.4% 0 8
Toxicity to various agents 8 5.4% 0 8
Acute generalised exanthematous pustulosis 7 4.7% 0 0
Pneumonia 7 4.7% 1 5

Who Reports ACETYLLEUCINE, L- Side Effects? Age & Gender Data

Gender: 54.4% female, 45.6% male. Average age: 38.5 years. Most reports from: FR. View detailed demographics →

Is ACETYLLEUCINE, L- Getting Safer? Reports by Year

YearReportsDeathsHosp.
2007 1 0 1
2013 3 0 3
2017 2 0 2
2020 18 0 17
2021 19 0 2
2022 27 10 10
2023 2 0 0
2024 13 1 4
2025 10 1 3

View full timeline →

What Is ACETYLLEUCINE, L- Used For?

IndicationReports
Product used for unknown indication 56
Vertigo 30
Gm2 gangliosidosis 14
Vestibular neuronitis 9
Ataxia 6
Neuronal ceroid lipofuscinosis 6
Niemann-pick disease 6

ACETYLLEUCINE, L- vs Alternatives: Which Is Safer?

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

Official FDA Label for ACETYLLEUCINE, L-

Official prescribing information from the FDA-approved drug label.