PMID- 35552457
OWN - NLM
STAT- MEDLINE
DCOM- 20220517
LR  - 20220716
IS  - 2045-2322 (Electronic)
IS  - 2045-2322 (Linking)
VI  - 12
IP  - 1
DP  - 2022 May 12
TI  - Frequently reported adverse events of rebamipide compared to other drugs for 
      peptic ulcer and gastroesophageal reflux disease.
PG  - 7839
LID - 10.1038/s41598-022-11505-0 [doi]
LID - 7839
AB  - This study aimed to detect safety signals of rebamipide and search for adverse 
      events (AEs) of rebamipide that are more common than those of other drugs for 
      peptic ulcer disease (PUD) and gastroesophageal reflux disease (GERD) in the 
      elderly population. A total of 101,735 AE reports for drugs used to treat PUD and 
      GERD between 2009 and 2018 from the KIDS-KAERS database (KIDS-KD) were used. 
      Disproportionality analysis was performed to calculate the proportional reporting 
      ratio (PRR), reporting odds ratio (ROR), and information component (IC). Drug 
      labels in Korea, Japan, and China were reviewed to identify signals that have 
      been listed. AEs frequently reported in the elderly population were also 
      analyzed. Seriousness and median time to AEs were evaluated for statistically 
      significant AEs. A total of 14 signals were detected, and 4 signals (dry mouth, 
      dermatitis, purpura/petechia, and fluid overload) were not listed on drug labels; 
      however, they may be included as part of other listed AEs. In the elderly 
      population, 11 AEs such as dyspepsia/indigestion/gastrointestinal distress, 
      somnolence, dry mouth, and edema were common. These AEs were not serious and 
      occurred within 2-9 days. This study identified possible AEs of rebamipide, a 
      relatively safe drug.
CI  - (c) 2022. The Author(s).
FAU - Jang, Eunkyeong
AU  - Jang E
AD  - College of Pharmacy, Ewha Womans University, Seoul, 03760, Republic of Korea.
FAU - Park, Minju
AU  - Park M
AD  - College of Pharmacy, Ewha Womans University, Seoul, 03760, Republic of Korea.
FAU - Jeong, Ji Eun
AU  - Jeong JE
AD  - College of Pharmacy, Ewha Womans University, Seoul, 03760, Republic of Korea.
FAU - Lee, Ji Young
AU  - Lee JY
AD  - College of Pharmacy, Ewha Womans University, Seoul, 03760, Republic of Korea.
FAU - Kim, Myeong Gyu
AU  - Kim MG
AD  - College of Pharmacy, Ewha Womans University, Seoul, 03760, Republic of Korea. 
      kimmg@ewha.ac.kr.
AD  - Graduate School of Pharmaceutical Sciences, Ewha Womans University, Seoul, 03760, 
      Republic of Korea. kimmg@ewha.ac.kr.
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20220512
PL  - England
TA  - Sci Rep
JT  - Scientific reports
JID - 101563288
RN  - 0 (Quinolones)
RN  - LR583V32ZR (rebamipide)
RN  - OF5P57N2ZX (Alanine)
SB  - IM
MH  - Adverse Drug Reaction Reporting Systems
MH  - Aged
MH  - Alanine/analogs & derivatives
MH  - *Gastroesophageal Reflux/drug therapy
MH  - Humans
MH  - *Peptic Ulcer/chemically induced/drug therapy
MH  - Quinolones
MH  - *Xerostomia
PMC - PMC9098635
COIS- The authors declare no competing interests.
EDAT- 2022/05/14 06:00
MHDA- 2022/05/18 06:00
PMCR- 2022/05/12
CRDT- 2022/05/13 14:18
PHST- 2022/03/01 00:00 [received]
PHST- 2022/04/22 00:00 [accepted]
PHST- 2022/05/13 14:18 [entrez]
PHST- 2022/05/14 06:00 [pubmed]
PHST- 2022/05/18 06:00 [medline]
PHST- 2022/05/12 00:00 [pmc-release]
AID - 10.1038/s41598-022-11505-0 [pii]
AID - 11505 [pii]
AID - 10.1038/s41598-022-11505-0 [doi]
PST - epublish
SO  - Sci Rep. 2022 May 12;12(1):7839. doi: 10.1038/s41598-022-11505-0.