PMID- 34127681 OWN - NLM STAT- MEDLINE DCOM- 20211101 LR - 20211101 IS - 2045-2322 (Electronic) IS - 2045-2322 (Linking) VI - 11 IP - 1 DP - 2021 Jun 14 TI - Systematic analysis of safety profile for darunavir and its boosted agents using data mining in the FDA Adverse Event Reporting System database. PG - 12438 LID - 10.1038/s41598-021-91549-w [doi] LID - 12438 AB - This current investigation was aimed to generate signals for adverse events (AEs) of darunavir-containing agents by data mining using the US Food and Drug Administration Adverse Event Reporting System (FAERS). All AE reports for darunavir, darunavir/ritonavir, or darunavir/cobicistat between July 2006 and December 2019 were identified. The reporting Odds Ratio (ROR), proportional reporting ratio (PRR), and Bayesian confidence propagation neural network (BCPNN) were used to detect the risk signals. A suspicious signal was generated only if the results of the three algorithms were all positive. A total of 10,756 reports were identified commonly observed in hepatobiliary, endocrine, cardiovascular, musculoskeletal, gastrointestinal, metabolic, and nutrition system. 40 suspicious signals were generated, and therein 20 signals were not included in the label. Severe high signals (i.e. progressive extraocular muscle paralysis, acute pancreatitis, exfoliative dermatitis, acquired lipodystrophy and mitochondrial toxicity) were identified. In pregnant women, umbilical cord abnormality, fetal growth restriction, low birth weight, stillbirth, premature rupture of membranes, premature birth and spontaneous abortion showed positive signals. Darunavir and its boosted agents induced AEs in various organs/tissues, and were shown to be possibly associated with multiple adverse pregnant conditions. This study highlighted some novel and severe AEs of darunavir which need to be monitored prospectively. FAU - Tian, Xiaojiang AU - Tian X AD - Department of Pharmacy, Chongqing Health Center for Women and Children, Chongqing, 400021, China. FAU - Yao, Yao AU - Yao Y AD - Department of Pharmacy, Chongqing Health Center for Women and Children, Chongqing, 400021, China. FAU - He, Guanglin AU - He G AD - Department of Anthropology and Ethnology, Institute of Anthropology, National Institute for Data Science in Health and Medicine, and School of Life Sciences, Xiamen University, Xiamen, 361005, China. FAU - Jia, Yuntao AU - Jia Y AD - Department of Pharmacy, Children's Hospital of Chongqing Medical University, Chongqing, 400014, China. FAU - Wang, Kejing AU - Wang K AD - Department of Pharmacy, Chongqing Health Center for Women and Children, Chongqing, 400021, China. xiaojiang0912@sina.com. FAU - Chen, Lin AU - Chen L AD - Department of Pharmacy, Chongqing Health Center for Women and Children, Chongqing, 400021, China. clfxmm@163.com. LA - eng PT - Journal Article DEP - 20210614 PL - England TA - Sci Rep JT - Scientific reports JID - 101563288 RN - 0 (HIV Protease Inhibitors) RN - YO603Y8113 (Darunavir) SB - IM MH - Adolescent MH - Adult MH - Adverse Drug Reaction Reporting Systems/*statistics & numerical data MH - Darunavir/*adverse effects MH - Data Mining MH - Drug-Related Side Effects and Adverse Reactions/*epidemiology/etiology MH - Female MH - HIV Infections/drug therapy MH - HIV Protease Inhibitors/*adverse effects MH - Humans MH - Male MH - Middle Aged MH - Pharmacovigilance MH - Pregnancy MH - Pregnancy Complications/chemically induced/*epidemiology MH - United States/epidemiology MH - United States Food and Drug Administration/statistics & numerical data MH - Young Adult PMC - PMC8203613 COIS- The authors declare no competing interests. EDAT- 2021/06/16 06:00 MHDA- 2021/11/03 06:00 PMCR- 2021/06/14 CRDT- 2021/06/15 06:21 PHST- 2021/02/09 00:00 [received] PHST- 2021/05/24 00:00 [accepted] PHST- 2021/06/15 06:21 [entrez] PHST- 2021/06/16 06:00 [pubmed] PHST- 2021/11/03 06:00 [medline] PHST- 2021/06/14 00:00 [pmc-release] AID - 10.1038/s41598-021-91549-w [pii] AID - 91549 [pii] AID - 10.1038/s41598-021-91549-w [doi] PST - epublish SO - Sci Rep. 2021 Jun 14;11(1):12438. doi: 10.1038/s41598-021-91549-w.