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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.

REBAMIPIDE: 427 Adverse Event Reports & Safety Profile

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427
Total FAERS Reports
32 (7.5%)
Deaths Reported
222
Hospitalizations
427
As Primary/Secondary Suspect
33
Life-Threatening
9
Disabilities

First Report: 20071105 · Latest Report: 20250905

What Are the Most Common REBAMIPIDE Side Effects?

#1 Most Reported
Hepatic function abnormal
30 reports (7.0%)
#2 Most Reported
Drug eruption
28 reports (6.6%)
#3 Most Reported
Rash
26 reports (6.1%)

All REBAMIPIDE Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Hepatic function abnormal 30 7.0% 2 17
Drug eruption 28 6.6% 1 12
Nausea 26 6.1% 1 14
Rash 26 6.1% 1 12
Vomiting 22 5.2% 0 8
Pyrexia 19 4.5% 1 19
Anaemia 18 4.2% 1 8
Diarrhoea 18 4.2% 1 10
Platelet count decreased 18 4.2% 1 7
Pruritus 18 4.2% 0 2
Off label use 17 4.0% 2 6
Dizziness 16 3.8% 0 6
Interstitial lung disease 14 3.3% 3 12
Alanine aminotransferase increased 13 3.0% 0 7
Aspartate aminotransferase increased 13 3.0% 0 6
Constipation 12 2.8% 1 9
Decreased appetite 12 2.8% 2 8
Drug-induced liver injury 12 2.8% 0 10
Dyspnoea 12 2.8% 0 4
Pancytopenia 12 2.8% 1 1

Who Reports REBAMIPIDE Side Effects? Age & Gender Data

Gender: 56.6% female, 43.4% male. Average age: 63.7 years. Most reports from: JP. View detailed demographics →

Is REBAMIPIDE Getting Safer? Reports by Year

YearReportsDeathsHosp.
2007 1 1 1
2008 1 0 0
2009 1 1 0
2010 8 0 4
2012 2 0 2
2013 8 2 3
2014 20 0 15
2015 50 4 33
2016 42 5 20
2017 35 3 21
2018 49 5 27
2019 22 3 7
2020 12 3 6
2021 30 2 14
2022 21 0 9
2023 15 1 6
2024 6 0 2
2025 3 0 1

View full timeline →

What Is REBAMIPIDE Used For?

IndicationReports
Product used for unknown indication 157
Prophylaxis 29
Chronic gastritis 15
Gastritis prophylaxis 14
Gastric ulcer 11
Gastritis 11
Abdominal discomfort 6
Prophylaxis against gastrointestinal ulcer 6
Gastrointestinal disorder 5
Gastrointestinal disorder prophylaxis 5

REBAMIPIDE vs Alternatives: Which Is Safer?

REBAMIPIDE vs REBETOL REBAMIPIDE vs REBIF REBAMIPIDE vs REBOXETINE REBAMIPIDE vs RECLAST REBAMIPIDE vs RECOMBINANT VARICELLA ZOSTER VIRUS GLYCOPROTEIN E REBAMIPIDE vs REGADENOSON REBAMIPIDE vs REGORAFENIB REBAMIPIDE vs REGORAFENIB\REGORAFENIB REBAMIPIDE vs RELATLIMAB REBAMIPIDE vs RELPAX

Official FDA Label for REBAMIPIDE

Official prescribing information from the FDA-approved drug label.