{"id":"https://openalex.org/W4387598705","doi":"https://doi.org/10.1007/s00737-023-01378-1","title":"Postmarketing safety profile of brexanolone: a pharmacovigilance analysis based on FDA Adverse Event Reporting System (FAERS)","display_name":"Postmarketing safety profile of brexanolone: a pharmacovigilance analysis based on FDA Adverse Event Reporting System (FAERS)","publication_year":2023,"publication_date":"2023-10-13","ids":{"openalex":"https://openalex.org/W4387598705","doi":"https://doi.org/10.1007/s00737-023-01378-1","pmid":"https://pubmed.ncbi.nlm.nih.gov/37831172"},"language":"en","primary_location":{"id":"doi:10.1007/s00737-023-01378-1","doi":"https://doi.org/10.1007/s00737-023-01378-1","is_oa":false,"landing_page_url":"https://doi.org/10.1007/s00737-023-01378-1","pdf_url":null,"source":{"id":"https://openalex.org/S4210187589","display_name":"Archives of Women s Mental Health","issn_l":"1434-1816","issn":["1434-1816","1435-1102"],"is_oa":false,"is_in_doaj":false,"is_core":true,"listed_in":["cwts-core","dongbi-c","doyens","jufo-1","ki-jl-1","medline","norway-1","poland-100","russia-white-list-1","vabb-shw"],"host_organization":"https://openalex.org/P4310319900","host_organization_name":"Springer Science+Business Media","host_organization_lineage":["https://openalex.org/P4310319900","https://openalex.org/P4310319965"],"host_organization_lineage_names":["Springer Science+Business Media","Springer Nature"],"type":"journal"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Archives of Women's Mental Health","raw_type":"journal-article"},"volume":null,"type":"article","indexed_in":["crossref","pubmed"],"open_access":{"is_oa":false,"oa_status":"closed","oa_url":null,"any_repository_has_fulltext":false},"authorships":[{"author_position":"first","author":{"id":"https://openalex.org/A5015709541","display_name":"Meilian Zhang","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I129708740","display_name":"Fujian Medical University","ror":"https://ror.org/050s6ns64","country_code":"CN","type":"education","lineage":["https://openalex.org/I129708740"]}],"countries":["CN"],"is_corresponding":false,"raw_author_name":"Meilian Zhang","raw_affiliation_strings":["Department of Ultrasound, Fujian Maternity and Child Health Hospital, College of Clinical Medicine for Obstetrics & Gynecology and Pediatrics, Fujian Medical University, Fuzhou, China"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Department of Ultrasound, Fujian Maternity and Child Health Hospital, College of Clinical Medicine for Obstetrics & Gynecology and Pediatrics, Fujian Medical University, Fuzhou, China","institution_ids":["https://openalex.org/I129708740"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5089306449","display_name":"Wenhuo Xie","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I129708740","display_name":"Fujian Medical University","ror":"https://ror.org/050s6ns64","country_code":"CN","type":"education","lineage":["https://openalex.org/I129708740"]}],"countries":["CN"],"is_corresponding":false,"raw_author_name":"Wenhuo Xie","raw_affiliation_strings":["Department of Clinical Pharmacy and Pharmacy Administration, School of Pharmacy, Fujian Medical University, Fuzhou, China"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Department of Clinical Pharmacy and Pharmacy Administration, School of Pharmacy, Fujian Medical University, Fuzhou, China","institution_ids":["https://openalex.org/I129708740"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5100356247","display_name":"Jianbin Li","orcid":"https://orcid.org/0000-0001-7813-0452","observed_orcids":["https://orcid.org/0000-0001-7813-0452"]},"institutions":[{"id":"https://openalex.org/I129708740","display_name":"Fujian Medical University","ror":"https://ror.org/050s6ns64","country_code":"CN","type":"education","lineage":["https://openalex.org/I129708740"]}],"countries":["CN"],"is_corresponding":false,"raw_author_name":"Jianbin Li","raw_affiliation_strings":["Department of Clinical Pharmacy and Pharmacy Administration, School of Pharmacy, Fujian Medical University, Fuzhou, China"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Department of Clinical Pharmacy and Pharmacy Administration, School of Pharmacy, Fujian Medical University, Fuzhou, China","institution_ids":["https://openalex.org/I129708740"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5040800641","display_name":"Jiaping Zheng","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I129708740","display_name":"Fujian Medical University","ror":"https://ror.org/050s6ns64","country_code":"CN","type":"education","lineage":["https://openalex.org/I129708740"]}],"countries":["CN"],"is_corresponding":true,"raw_author_name":"Jiaping Zheng","raw_affiliation_strings":["Department of Rehabilitation Medicine, School of Health, Fujian Medical University, Fuzhou, China. zhengjp@fjmu.edu.cn","Department of Rehabilitation Medicine, School of Health, Fujian Medical University, Fuzhou, China"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Department of Rehabilitation Medicine, School of Health, Fujian Medical University, Fuzhou, China. zhengjp@fjmu.edu.cn","institution_ids":["https://openalex.org/I129708740"]},{"raw_affiliation_string":"Department of Rehabilitation Medicine, School of Health, Fujian Medical University, Fuzhou, China","institution_ids":["https://openalex.org/I129708740"]}]},{"author_position":"last","author":{"id":"https://openalex.org/A5026216205","display_name":"Yu Zhou","orcid":"https://orcid.org/0000-0003-1942-3073","observed_orcids":["https://orcid.org/0000-0003-1942-3073"]},"institutions":[{"id":"https://openalex.org/I129708740","display_name":"Fujian Medical University","ror":"https://ror.org/050s6ns64","country_code":"CN","type":"education","lineage":["https://openalex.org/I129708740"]}],"countries":["CN"],"is_corresponding":true,"raw_author_name":"Yu Zhou","raw_affiliation_strings":["Department of Clinical Pharmacy and Pharmacy Administration, School of Pharmacy, Fujian Medical University, Fuzhou, China. cfjsczy@fjmu.edu.cn","Department of Clinical Pharmacy and Pharmacy Administration, School of Pharmacy, Fujian Medical University, Fuzhou, China"],"raw_orcid":"https://orcid.org/0000-0003-1942-3073","affiliations":[{"raw_affiliation_string":"Department of Clinical Pharmacy and Pharmacy Administration, School of Pharmacy, Fujian Medical University, Fuzhou, China. cfjsczy@fjmu.edu.cn","institution_ids":["https://openalex.org/I129708740"]},{"raw_affiliation_string":"Department of Clinical Pharmacy and Pharmacy Administration, School of Pharmacy, Fujian Medical University, Fuzhou, China","institution_ids":["https://openalex.org/I129708740"]}]}],"institutions":[],"countries_distinct_count":1,"institutions_distinct_count":1,"corresponding_author_ids":["https://openalex.org/A5026216205","https://openalex.org/A5040800641"],"corresponding_institution_ids":["https://openalex.org/I129708740"],"apc_list":{"value":3590,"currency":"USD","value_usd":3590},"apc_paid":null,"fwci":9.523,"has_fulltext":false,"cited_by_count":15,"citation_normalized_percentile":{"value":0.97111124,"is_in_top_1_percent":false,"is_in_top_10_percent":true},"cited_by_percentile_year":{"min":89,"max":99},"biblio":{"volume":"27","issue":"1","first_page":"35","last_page":"44"},"is_retracted":false,"is_paratext":false,"is_xpac":false,"primary_topic":{"id":"https://openalex.org/T11943","display_name":"Pharmacovigilance and Adverse Drug Reactions","score":0.9970999956130981,"subfield":{"id":"https://openalex.org/subfields/3005","display_name":"Toxicology"},"field":{"id":"https://openalex.org/fields/30","display_name":"Pharmacology, Toxicology and Pharmaceutics"},"domain":{"id":"https://openalex.org/domains/1","display_name":"Life Sciences"}},"topics":[{"id":"https://openalex.org/T11943","display_name":"Pharmacovigilance and Adverse Drug Reactions","score":0.9970999956130981,"subfield":{"id":"https://openalex.org/subfields/3005","display_name":"Toxicology"},"field":{"id":"https://openalex.org/fields/30","display_name":"Pharmacology, Toxicology and Pharmaceutics"},"domain":{"id":"https://openalex.org/domains/1","display_name":"Life Sciences"}},{"id":"https://openalex.org/T10786","display_name":"Maternal Mental Health During Pregnancy and Postpartum","score":0.0006000000284984708,"subfield":{"id":"https://openalex.org/subfields/2739","display_name":"Public Health, Environmental and Occupational Health"},"field":{"id":"https://openalex.org/fields/27","display_name":"Medicine"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}},{"id":"https://openalex.org/T11649","display_name":"Pharmaceutical industry and healthcare","score":9.999999747378752e-05,"subfield":{"id":"https://openalex.org/subfields/3004","display_name":"Pharmacology"},"field":{"id":"https://openalex.org/fields/30","display_name":"Pharmacology, Toxicology and Pharmaceutics"},"domain":{"id":"https://openalex.org/domains/1","display_name":"Life Sciences"}}],"keywords":[{"id":"https://openalex.org/keywords/brexanolone","display_name":"brexanolone","score":1.0},{"id":"https://openalex.org/keywords/post-marketing-safety","display_name":"post-marketing safety","score":0.7839999794960022},{"id":"https://openalex.org/keywords/adverse-drug-reactions","display_name":"adverse drug reactions","score":0.9570000171661377},{"id":"https://openalex.org/keywords/postpartum-depression","display_name":"postpartum depression","score":0.9750000238418579},{"id":"https://openalex.org/keywords/perinatal-depression","display_name":"perinatal depression","score":0.9639999866485596},{"id":"https://openalex.org/keywords/disproportionality-analysis","display_name":"disproportionality analysis","score":0.8460000157356262},{"id":"https://openalex.org/keywords/selective-serotonin-reuptake-inhibitors","display_name":"selective serotonin reuptake inhibitors","score":0.8389999866485596},{"id":"https://openalex.org/keywords/psychiatric-adverse-events","display_name":"psychiatric adverse events","score":0.8149999976158142},{"id":"https://openalex.org/keywords/medication-discontinuation","display_name":"drug discontinuation","score":0.5590000152587891}],"concepts":[{"id":"https://openalex.org/C57658597","wikidata":"https://www.wikidata.org/wiki/Q1550789","display_name":"Pharmacovigilance","level":3,"score":0.9157037734985352},{"id":"https://openalex.org/C2777105317","wikidata":"https://www.wikidata.org/wiki/Q4686710","display_name":"Adverse Event Reporting System","level":3,"score":0.8269956111907959},{"id":"https://openalex.org/C71924100","wikidata":"https://www.wikidata.org/wiki/Q11190","display_name":"Medicine","level":0,"score":0.78802090883255},{"id":"https://openalex.org/C197636746","wikidata":"https://www.wikidata.org/wiki/Q7234359","display_name":"Postmarketing surveillance","level":3,"score":0.6226919293403625},{"id":"https://openalex.org/C197934379","wikidata":"https://www.wikidata.org/wiki/Q2047938","display_name":"Adverse effect","level":2,"score":0.5562067627906799},{"id":"https://openalex.org/C2778715236","wikidata":"https://www.wikidata.org/wiki/Q55622662","display_name":"Discontinuation","level":2,"score":0.5342127084732056},{"id":"https://openalex.org/C2776867660","wikidata":"https://www.wikidata.org/wiki/Q1814941","display_name":"Depression (economics)","level":2,"score":0.511814534664154},{"id":"https://openalex.org/C23276603","wikidata":"https://www.wikidata.org/wiki/Q158230","display_name":"Pharmacoepidemiology","level":3,"score":0.49339786171913147},{"id":"https://openalex.org/C156957248","wikidata":"https://www.wikidata.org/wiki/Q1862216","display_name":"Odds ratio","level":2,"score":0.4814240634441376},{"id":"https://openalex.org/C44249647","wikidata":"https://www.wikidata.org/wiki/Q208498","display_name":"Confidence interval","level":2,"score":0.4277998208999634},{"id":"https://openalex.org/C98274493","wikidata":"https://www.wikidata.org/wiki/Q128406","display_name":"Pharmacology","level":1,"score":0.317454993724823},{"id":"https://openalex.org/C118552586","wikidata":"https://www.wikidata.org/wiki/Q7867","display_name":"Psychiatry","level":1,"score":0.31146061420440674},{"id":"https://openalex.org/C126322002","wikidata":"https://www.wikidata.org/wiki/Q11180","display_name":"Internal medicine","level":1,"score":0.30905449390411377},{"id":"https://openalex.org/C139719470","wikidata":"https://www.wikidata.org/wiki/Q39680","display_name":"Macroeconomics","level":1,"score":0.0},{"id":"https://openalex.org/C2426938","wikidata":"https://www.wikidata.org/wiki/Q3355478","display_name":"Medical prescription","level":2,"score":0.0},{"id":"https://openalex.org/C162324750","wikidata":"https://www.wikidata.org/wiki/Q8134","display_name":"Economics","level":0,"score":0.0}],"mesh":[{"descriptor_ui":"D004338","descriptor_name":"Drug Combinations","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D004338","descriptor_name":"Drug Combinations","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D004338","descriptor_name":"Drug Combinations","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D004338","descriptor_name":"Drug Combinations","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D005260","descriptor_name":"Female","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D005260","descriptor_name":"Female","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D005260","descriptor_name":"Female","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D005260","descriptor_name":"Female","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D006801","descriptor_name":"Humans","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D006801","descriptor_name":"Humans","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D006801","descriptor_name":"Humans","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D006801","descriptor_name":"Humans","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D011247","descriptor_name":"Pregnancy","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D011247","descriptor_name":"Pregnancy","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D011247","descriptor_name":"Pregnancy","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D011247","descriptor_name":"Pregnancy","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D011280","descriptor_name":"Pregnanolone","qualifier_ui":"Q000009","qualifier_name":"adverse effects","is_major_topic":false},{"descriptor_ui":"D011280","descriptor_name":"Pregnanolone","qualifier_ui":"Q000009","qualifier_name":"adverse effects","is_major_topic":false},{"descriptor_ui":"D011280","descriptor_name":"Pregnanolone","qualifier_ui":"Q000009","qualifier_name":"adverse effects","is_major_topic":false},{"descriptor_ui":"D011280","descriptor_name":"Pregnanolone","qualifier_ui":"Q000009","qualifier_name":"adverse effects","is_major_topic":false},{"descriptor_ui":"D011446","descriptor_name":"Prospective Studies","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D011446","descriptor_name":"Prospective Studies","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D011446","descriptor_name":"Prospective Studies","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D011446","descriptor_name":"Prospective Studies","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D014481","descriptor_name":"United States","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D014481","descriptor_name":"United States","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D014481","descriptor_name":"United States","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D014481","descriptor_name":"United States","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D014486","descriptor_name":"United States Food and Drug Administration","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D014486","descriptor_name":"United States Food and Drug Administration","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D014486","descriptor_name":"United States Food and Drug Administration","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D014486","descriptor_name":"United States Food and Drug Administration","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D017367","descriptor_name":"Selective Serotonin Reuptake Inhibitors","qualifier_ui":"Q000009","qualifier_name":"adverse effects","is_major_topic":true},{"descriptor_ui":"D017367","descriptor_name":"Selective Serotonin Reuptake Inhibitors","qualifier_ui":"Q000009","qualifier_name":"adverse effects","is_major_topic":true},{"descriptor_ui":"D017367","descriptor_name":"Selective Serotonin Reuptake Inhibitors","qualifier_ui":"Q000009","qualifier_name":"adverse effects","is_major_topic":true},{"descriptor_ui":"D017367","descriptor_name":"Selective Serotonin Reuptake Inhibitors","qualifier_ui":"Q000009","qualifier_name":"adverse effects","is_major_topic":true},{"descriptor_ui":"D047392","descriptor_name":"beta-Cyclodextrins","qualifier_ui":null,"qualifier_name":null,"is_major_topic":true},{"descriptor_ui":"D047392","descriptor_name":"beta-Cyclodextrins","qualifier_ui":null,"qualifier_name":null,"is_major_topic":true},{"descriptor_ui":"D047392","descriptor_name":"beta-Cyclodextrins","qualifier_ui":null,"qualifier_name":null,"is_major_topic":true},{"descriptor_ui":"D047392","descriptor_name":"beta-Cyclodextrins","qualifier_ui":null,"qualifier_name":null,"is_major_topic":true},{"descriptor_ui":"D060735","descriptor_name":"Pharmacovigilance","qualifier_ui":null,"qualifier_name":null,"is_major_topic":true},{"descriptor_ui":"D060735","descriptor_name":"Pharmacovigilance","qualifier_ui":null,"qualifier_name":null,"is_major_topic":true},{"descriptor_ui":"D060735","descriptor_name":"Pharmacovigilance","qualifier_ui":null,"qualifier_name":null,"is_major_topic":true},{"descriptor_ui":"D060735","descriptor_name":"Pharmacovigilance","qualifier_ui":null,"qualifier_name":null,"is_major_topic":true}],"locations_count":2,"locations":[{"id":"doi:10.1007/s00737-023-01378-1","doi":"https://doi.org/10.1007/s00737-023-01378-1","is_oa":false,"landing_page_url":"https://doi.org/10.1007/s00737-023-01378-1","pdf_url":null,"source":{"id":"https://openalex.org/S4210187589","display_name":"Archives of Women s Mental Health","issn_l":"1434-1816","issn":["1434-1816","1435-1102"],"is_oa":false,"is_in_doaj":false,"is_core":true,"listed_in":["cwts-core","dongbi-c","doyens","jufo-1","ki-jl-1","medline","norway-1","poland-100","russia-white-list-1","vabb-shw"],"host_organization":"https://openalex.org/P4310319900","host_organization_name":"Springer Science+Business Media","host_organization_lineage":["https://openalex.org/P4310319900","https://openalex.org/P4310319965"],"host_organization_lineage_names":["Springer Science+Business Media","Springer Nature"],"type":"journal"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Archives of Women's Mental Health","raw_type":"journal-article"},{"id":"pmid:37831172","doi":null,"is_oa":false,"landing_page_url":"https://pubmed.ncbi.nlm.nih.gov/37831172","pdf_url":null,"source":{"id":"https://openalex.org/S4306525036","display_name":"PubMed","issn_l":null,"issn":null,"is_oa":false,"is_in_doaj":false,"is_core":false,"listed_in":[],"host_organization":"https://openalex.org/I1299303238","host_organization_name":"National Institutes of Health","host_organization_lineage":["https://openalex.org/I1299303238"],"host_organization_lineage_names":[],"type":"repository"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Archives of women's mental health","raw_type":"Journal Article"}],"best_oa_location":null,"sustainable_development_goals":[{"score":1.0,"display_name":"Good health and well-being","id":"https://metadata.un.org/sdg/3"}],"sustainable_development_goals_aurora":[{"score":0.8500000238418579,"display_name":"Good health and well-being","id":"https://metadata.un.org/sdg/3"}],"study_designs":[{"display_name":"Observational Study","id":"https://openalex.org/study-designs/observational-study"}],"awards":[],"funders":[],"has_content":{"pdf":false,"grobid_xml":false},"content_urls":null,"referenced_works_count":23,"referenced_works":["https://openalex.org/W2005366883","https://openalex.org/W2012932867","https://openalex.org/W2085358740","https://openalex.org/W2114921087","https://openalex.org/W2598012653","https://openalex.org/W2626607634","https://openalex.org/W2794431233","https://openalex.org/W2889396010","https://openalex.org/W2896939971","https://openalex.org/W2914543137","https://openalex.org/W2916664976","https://openalex.org/W2972225326","https://openalex.org/W2983463140","https://openalex.org/W3012367474","https://openalex.org/W3047436183","https://openalex.org/W3082360571","https://openalex.org/W3113164066","https://openalex.org/W3193337461","https://openalex.org/W3199138735","https://openalex.org/W4239700635","https://openalex.org/W4247665917","https://openalex.org/W4298112110","https://openalex.org/W4309842649"],"related_works":["https://openalex.org/W2380396032","https://openalex.org/W2204990270","https://openalex.org/W2166639438","https://openalex.org/W2980723253","https://openalex.org/W1630095485","https://openalex.org/W157859230","https://openalex.org/W1979198508","https://openalex.org/W2908992680","https://openalex.org/W2331399373","https://openalex.org/W3811925"],"abstract_inverted_index":null,"counts_by_year":[{"year":2026,"cited_by_count":2},{"year":2025,"cited_by_count":6},{"year":2024,"cited_by_count":6},{"year":2023,"cited_by_count":1}],"updated_date":"2026-10-12T09:40:04.860316","created_date":"2025-10-10T00:00:00"}