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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.

RACECADOTRIL: 729 Adverse Event Reports & Safety Profile

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729
Total FAERS Reports
162 (22.2%)
Deaths Reported
475
Hospitalizations
729
As Primary/Secondary Suspect
123
Life-Threatening

First Report: 20050802 · Latest Report: 20250811

What Are the Most Common RACECADOTRIL Side Effects?

#1 Most Reported
Toxic epidermal necrolysis
83 reports (11.4%)
#2 Most Reported
Acute kidney injury
80 reports (11.0%)
#3 Most Reported
Rash maculo-papular
69 reports (9.5%)

All RACECADOTRIL Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Toxic epidermal necrolysis 83 11.4% 72 68
Acute kidney injury 80 11.0% 31 53
Rash maculo-papular 69 9.5% 23 56
Confusional state 55 7.5% 5 40
Drug reaction with eosinophilia and systemic symptoms 49 6.7% 4 40
Eosinophilia 49 6.7% 23 41
Thrombocytopenia 41 5.6% 23 33
Hepatocellular injury 39 5.4% 7 19
Somnolence 37 5.1% 0 25
Off label use 32 4.4% 13 11
Vomiting 29 4.0% 2 27
Acute generalised exanthematous pustulosis 27 3.7% 0 15
Cholestasis 27 3.7% 21 16
Death 26 3.6% 26 26
Dyspnoea 26 3.6% 24 26
Rectal haemorrhage 25 3.4% 23 25
Sepsis 25 3.4% 23 25
Diffuse alveolar damage 24 3.3% 23 24
Eczema 24 3.3% 23 24
Generalised oedema 24 3.3% 24 24

Who Reports RACECADOTRIL Side Effects? Age & Gender Data

Gender: 48.1% female, 51.9% male. Average age: 60.1 years. Most reports from: FR. View detailed demographics →

Is RACECADOTRIL Getting Safer? Reports by Year

YearReportsDeathsHosp.
2005 1 0 1
2007 3 0 3
2009 1 0 0
2012 4 2 2
2013 2 0 2
2014 11 1 7
2015 27 14 25
2016 61 23 47
2017 93 20 78
2018 40 0 28
2019 100 11 35
2020 122 57 86
2021 57 15 43
2022 69 1 49
2023 46 0 20
2024 24 0 12
2025 17 14 2

View full timeline →

What Is RACECADOTRIL Used For?

IndicationReports
Diarrhoea 387
Product used for unknown indication 201
Prophylaxis against diarrhoea 26
Poisoning deliberate 15
Abdominal pain 14
Suicide attempt 9
Toxicity to various agents 8
Chest scan 7
Skin infection 7
Gastroenteritis 6

RACECADOTRIL vs Alternatives: Which Is Safer?

RACECADOTRIL vs RADIATION THERAPY RACECADOTRIL vs RADIUM RA-223 DICHLORIDE RACECADOTRIL vs RALOXIFENE RACECADOTRIL vs RALTEGRAVIR RACECADOTRIL vs RALTITREXED RACECADOTRIL vs RAMELTEON RACECADOTRIL vs RAMIPRIL RACECADOTRIL vs RAMUCIRUMAB RACECADOTRIL vs RANEXA RACECADOTRIL vs RANIBIZUMAB

Official FDA Label for RACECADOTRIL

Official prescribing information from the FDA-approved drug label.