PMID- 37992768
OWN - NLM
STAT- MEDLINE
DCOM- 20240108
LR  - 20240208
IS  - 1573-2517 (Electronic)
IS  - 0165-0327 (Linking)
VI  - 347
DP  - 2024 Feb 15
TI  - Mining and analysis of adverse event signals of Cariprazine based on the 
      real-world data of FAERS database.
PG  - 45-50
LID - S0165-0327(23)01445-3 [pii]
LID - 10.1016/j.jad.2023.11.076 [doi]
AB  - OBJECTIVE: This study aims to analyze the adverse events (AEs) of Cariprazine 
      based on the FAERS database, providing evidence for its safety surveillance. 
      METHODS: For signal quantification of Cariprazine-related AEs, we used 
      disproportionality analysis including the Ratio of Odds Ratio (ROR), Proportional 
      Reporting Ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), 
      and Multi-Item Gamma Poisson Shrinker (MGPS) algorithms. RESULTS: We selected 
      Cariprazine-related AE reports from the FAERS database from the fourth quarter of 
      2015 to the first quarter of 2023, and performed a detailed data analysis. Out of 
      a total of 12,278,580 case reports, 3659 were found to be directly related to 
      Cariprazine. We identified 140 Preferred Terms (PT) to describe these AEs, 
      finding that they involved 27 organ systems. Specifically, AEs related to eye 
      disorders such as Cataract cortical, Cataract nuclear, Accommodation disorder, 
      Lenticular opacities, Oculogyric crisis, Dyschromatopsia were not explicitly 
      mentioned in the drug's leaflet, indicating the presence of new ADR signals. 
      CONCLUSION: Analysis of the FAERS database identified AEs associated with 
      Cariprazine, notably in eye disorders not previously documented in the drug's 
      official leaflet. These findings emphasize the need for continuous post-market 
      surveillance and awareness among healthcare professionals regarding potential new 
      ADR signals.
CI  - Copyright (c) 2023 Elsevier B.V. All rights reserved.
FAU - Zhu, Haohao
AU  - Zhu H
AD  - Mental Health Center of Jiangnan University, Wuxi Central Rehabilitation 
      Hospital, Wuxi, Jiangsu, China.
FAU - Qu, Yucai
AU  - Qu Y
AD  - Mental Health Center of Jiangnan University, Wuxi Central Rehabilitation 
      Hospital, Wuxi, Jiangsu, China.
FAU - Du, Zhiqiang
AU  - Du Z
AD  - Mental Health Center of Jiangnan University, Wuxi Central Rehabilitation 
      Hospital, Wuxi, Jiangsu, China.
FAU - Zhou, Qin
AU  - Zhou Q
AD  - Mental Health Center of Jiangnan University, Wuxi Central Rehabilitation 
      Hospital, Wuxi, Jiangsu, China.
FAU - Shen, Yuan
AU  - Shen Y
AD  - Mental Health Center of Jiangnan University, Wuxi Central Rehabilitation 
      Hospital, Wuxi, Jiangsu, China.
FAU - Jiang, Ying
AU  - Jiang Y
AD  - Mental Health Center of Jiangnan University, Wuxi Central Rehabilitation 
      Hospital, Wuxi, Jiangsu, China. Electronic address: 
      jiangying1010@jiangnan.edu.cn.
FAU - Zhou, Zhenhe
AU  - Zhou Z
AD  - Mental Health Center of Jiangnan University, Wuxi Central Rehabilitation 
      Hospital, Wuxi, Jiangsu, China. Electronic address: zhouzh@jiangnan.edu.cn.
FAU - Zhou, Hongliang
AU  - Zhou H
AD  - Department of Psychology, The Affiliated Hospital of Jiangnan University, Wuxi, 
      Jiangsu, China. Electronic address: Hongliangzh2022@hotmail.com.
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20231120
PL  - Netherlands
TA  - J Affect Disord
JT  - Journal of affective disorders
JID - 7906073
RN  - F6RJL8B278 (cariprazine)
SB  - IM
MH  - Humans
MH  - United States
MH  - Adverse Drug Reaction Reporting Systems
MH  - Bayes Theorem
MH  - *Drug-Related Side Effects and Adverse Reactions/epidemiology
MH  - *Cataract
MH  - *Eye Diseases
OTO - NOTNLM
OT  - Adverse drug reaction
OT  - Adverse events
OT  - Cariprazine
OT  - FDA adverse event reporting system
OT  - Real-world data analysis
COIS- Declaration of competing interest The authors declare no conflicts of interest.
EDAT- 2023/11/23 00:42
MHDA- 2024/01/08 06:42
CRDT- 2023/11/22 19:27
PHST- 2023/08/16 00:00 [received]
PHST- 2023/11/16 00:00 [revised]
PHST- 2023/11/19 00:00 [accepted]
PHST- 2024/01/08 06:42 [medline]
PHST- 2023/11/23 00:42 [pubmed]
PHST- 2023/11/22 19:27 [entrez]
AID - S0165-0327(23)01445-3 [pii]
AID - 10.1016/j.jad.2023.11.076 [doi]
PST - ppublish
SO  - J Affect Disord. 2024 Feb 15;347:45-50. doi: 10.1016/j.jad.2023.11.076. Epub 2023 
      Nov 20.