{"id":"https://openalex.org/W7225823053","doi":"https://doi.org/10.1177/22313354261492930","title":"Disproportionality Analysis of Fentanyl in Children Using Real-world Data from the FDA Adverse Event Reporting System (FAERS) Database","display_name":"Disproportionality Analysis of Fentanyl in Children Using Real-world Data from the FDA Adverse Event Reporting System (FAERS) Database","publication_year":2026,"publication_date":"2026-11-11","ids":{"openalex":"https://openalex.org/W7225823053","doi":"https://doi.org/10.1177/22313354261492930"},"language":"en","primary_location":{"id":"doi:10.1177/22313354261492930","doi":"https://doi.org/10.1177/22313354261492930","is_oa":true,"landing_page_url":"https://doi.org/10.1177/22313354261492930","pdf_url":null,"source":{"id":"https://openalex.org/S2764844132","display_name":"Journal of Applied Pharmaceutical Science","issn_l":"2231-3354","issn":["2231-3354"],"is_oa":true,"is_in_doaj":false,"is_core":true,"listed_in":["cwts-core","norway-1","poland-40","russia-white-list-2"],"host_organization":"https://openalex.org/P4327876862","host_organization_name":"Open Science Publishers LLP","host_organization_lineage":["https://openalex.org/P4327876862"],"host_organization_lineage_names":["Open Science Publishers LLP"],"type":"journal"},"license":"cc-by-nc","license_id":"https://openalex.org/licenses/cc-by-nc","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Journal of Applied Pharmaceutical Science","raw_type":"journal-article"},"volume":null,"type":"article","is_traditional":true,"indexed_in":["crossref"],"open_access":{"is_oa":true,"oa_status":"diamond","oa_url":"https://doi.org/10.1177/22313354261492930","any_repository_has_fulltext":false},"authorships":[{"author_position":"first","author":{"id":"https://openalex.org/A5098947092","display_name":"Shwetha Somakumar","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I164861460","display_name":"Manipal Academy of Higher Education","ror":"https://ror.org/02xzytt36","country_code":"IN","type":"education","lineage":["https://openalex.org/I164861460"]}],"countries":["IN"],"is_corresponding":false,"raw_author_name":"Shwetha Somakumar","raw_affiliation_strings":["Department of Pharmacy Practice, Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education, Manipal, Karnataka, India"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Department of Pharmacy Practice, Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education, Manipal, Karnataka, India","institution_ids":["https://openalex.org/I164861460"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5090823423","display_name":"Arunangshu Ghoshal","orcid":"https://orcid.org/0000-0001-9975-2568","observed_orcids":["https://orcid.org/0000-0001-9975-2568"]},"institutions":[{"id":"https://openalex.org/I164861460","display_name":"Manipal Academy of Higher Education","ror":"https://ror.org/02xzytt36","country_code":"IN","type":"education","lineage":["https://openalex.org/I164861460"]},{"id":"https://openalex.org/I76414455","display_name":"Kasturba Medical College, Manipal","ror":"https://ror.org/05hg48t65","country_code":"IN","type":"education","lineage":["https://openalex.org/I164861460","https://openalex.org/I76414455"]}],"countries":["IN"],"is_corresponding":false,"raw_author_name":"Arun Ghoshal","raw_affiliation_strings":["Department of Palliative Medicine and Supportive Care, Kasturba Medical College, Manipal Academy of Higher Education, Manipal, Karnataka, India"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Department of Palliative Medicine and Supportive Care, Kasturba Medical College, Manipal Academy of Higher Education, Manipal, Karnataka, India","institution_ids":["https://openalex.org/I164861460","https://openalex.org/I76414455"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5032346436","display_name":"Vasudeva Bhat K","orcid":"https://orcid.org/0000-0002-4081-1372","observed_orcids":["https://orcid.org/0000-0002-4081-1372"]},"institutions":[{"id":"https://openalex.org/I164861460","display_name":"Manipal Academy of Higher Education","ror":"https://ror.org/02xzytt36","country_code":"IN","type":"education","lineage":["https://openalex.org/I164861460"]},{"id":"https://openalex.org/I76414455","display_name":"Kasturba Medical College, Manipal","ror":"https://ror.org/05hg48t65","country_code":"IN","type":"education","lineage":["https://openalex.org/I164861460","https://openalex.org/I76414455"]}],"countries":["IN"],"is_corresponding":false,"raw_author_name":"Vasudeva Bhat K","raw_affiliation_strings":["Department of Pediatric Oncology, Kasturba Medical College, Manipal Academy of Higher Education, Manipal, Karnataka, India"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Department of Pediatric Oncology, Kasturba Medical College, Manipal Academy of Higher Education, Manipal, Karnataka, India","institution_ids":["https://openalex.org/I164861460","https://openalex.org/I76414455"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5161421290","display_name":"Krithika Shantanu Rao","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I164861460","display_name":"Manipal Academy of Higher Education","ror":"https://ror.org/02xzytt36","country_code":"IN","type":"education","lineage":["https://openalex.org/I164861460"]},{"id":"https://openalex.org/I76414455","display_name":"Kasturba Medical College, Manipal","ror":"https://ror.org/05hg48t65","country_code":"IN","type":"education","lineage":["https://openalex.org/I164861460","https://openalex.org/I76414455"]}],"countries":["IN"],"is_corresponding":false,"raw_author_name":"Krithika Shantanu Rao","raw_affiliation_strings":["Department of Palliative Medicine and Supportive Care, Kasturba Medical College, Manipal Academy of Higher Education, Manipal, Karnataka, India"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Department of Palliative Medicine and Supportive Care, Kasturba Medical College, Manipal Academy of Higher Education, Manipal, Karnataka, India","institution_ids":["https://openalex.org/I164861460","https://openalex.org/I76414455"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5062944208","display_name":"Naveen S. Salins","orcid":"https://orcid.org/0000-0001-5237-9874","observed_orcids":["https://orcid.org/0000-0001-5237-9874"]},"institutions":[{"id":"https://openalex.org/I164861460","display_name":"Manipal Academy of Higher Education","ror":"https://ror.org/02xzytt36","country_code":"IN","type":"education","lineage":["https://openalex.org/I164861460"]},{"id":"https://openalex.org/I76414455","display_name":"Kasturba Medical College, Manipal","ror":"https://ror.org/05hg48t65","country_code":"IN","type":"education","lineage":["https://openalex.org/I164861460","https://openalex.org/I76414455"]}],"countries":["IN"],"is_corresponding":false,"raw_author_name":"Naveen Salins","raw_affiliation_strings":["Department of Palliative Medicine and Supportive Care, Kasturba Medical College, Manipal Academy of Higher Education, Manipal, Karnataka, India"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Department of Palliative Medicine and Supportive Care, Kasturba Medical College, Manipal Academy of Higher Education, Manipal, Karnataka, India","institution_ids":["https://openalex.org/I164861460","https://openalex.org/I76414455"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5013196041","display_name":"Gouri Nair","orcid":"https://orcid.org/0000-0003-2081-6827","observed_orcids":["https://orcid.org/0000-0003-2081-6827"]},"institutions":[{"id":"https://openalex.org/I302410947","display_name":"M S Ramaiah University of Applied Sciences","ror":"https://ror.org/02anh8x74","country_code":"IN","type":"education","lineage":["https://openalex.org/I302410947"]}],"countries":["IN"],"is_corresponding":false,"raw_author_name":"Gouri Nair","raw_affiliation_strings":["Department of Pharmacology, Faculty of Pharmacy, M. S. Ramaiah University of Applied Sciences, Bengaluru, Karnataka, India"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Department of Pharmacology, Faculty of Pharmacy, M. S. Ramaiah University of Applied Sciences, Bengaluru, Karnataka, India","institution_ids":["https://openalex.org/I302410947"]}]},{"author_position":"last","author":{"id":"https://openalex.org/A5109342864","display_name":"Rajesh Vilakkathala","orcid":"https://orcid.org/0000-0003-1261-4977","observed_orcids":["https://orcid.org/0000-0003-1261-4977"]},"institutions":[{"id":"https://openalex.org/I164861460","display_name":"Manipal Academy of Higher Education","ror":"https://ror.org/02xzytt36","country_code":"IN","type":"education","lineage":["https://openalex.org/I164861460"]}],"countries":["IN"],"is_corresponding":false,"raw_author_name":"Rajesh V","raw_affiliation_strings":["Department of Pharmacy Practice, Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education, Manipal, Karnataka, India"],"raw_orcid":"https://orcid.org/0000-0003-1261-4977","affiliations":[{"raw_affiliation_string":"Department of Pharmacy Practice, Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education, Manipal, Karnataka, India","institution_ids":["https://openalex.org/I164861460"]}]}],"institutions":[],"countries_distinct_count":1,"institutions_distinct_count":3,"corresponding_author_ids":[],"corresponding_institution_ids":[],"apc_list":null,"apc_paid":null,"fwci":0.0,"has_fulltext":false,"cited_by_count":0,"citation_normalized_percentile":{"value":0.0,"is_in_top_1_percent":false,"is_in_top_10_percent":false},"cited_by_percentile_year":null,"biblio":{"volume":null,"issue":null,"first_page":null,"last_page":null},"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/T12547","display_name":"Pharmaceutical studies and practices","score":0.0010999999940395355,"subfield":{"id":"https://openalex.org/subfields/2735","display_name":"Pediatrics, Perinatology and Child 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/T11199","display_name":"Pain Management and Opioid Use","score":0.00019999999494757503,"subfield":{"id":"https://openalex.org/subfields/2703","display_name":"Anesthesiology and Pain Medicine"},"field":{"id":"https://openalex.org/fields/27","display_name":"Medicine"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}}],"keywords":[],"concepts":[{"id":"https://openalex.org/C71924100","wikidata":"https://www.wikidata.org/wiki/Q11190","display_name":"Medicine","level":0,"score":0.7883999943733215},{"id":"https://openalex.org/C2781072394","wikidata":"https://www.wikidata.org/wiki/Q407541","display_name":"Fentanyl","level":2,"score":0.7390999794006348},{"id":"https://openalex.org/C57658597","wikidata":"https://www.wikidata.org/wiki/Q1550789","display_name":"Pharmacovigilance","level":3,"score":0.722000002861023},{"id":"https://openalex.org/C2777105317","wikidata":"https://www.wikidata.org/wiki/Q4686710","display_name":"Adverse Event Reporting System","level":3,"score":0.6675999760627747},{"id":"https://openalex.org/C197934379","wikidata":"https://www.wikidata.org/wiki/Q2047938","display_name":"Adverse effect","level":2,"score":0.6394000053405762},{"id":"https://openalex.org/C160798450","wikidata":"https://www.wikidata.org/wiki/Q4230870","display_name":"Concordance","level":2,"score":0.5781999826431274},{"id":"https://openalex.org/C197636746","wikidata":"https://www.wikidata.org/wiki/Q7234359","display_name":"Postmarketing surveillance","level":3,"score":0.5105999708175659},{"id":"https://openalex.org/C156957248","wikidata":"https://www.wikidata.org/wiki/Q1862216","display_name":"Odds ratio","level":2,"score":0.44350001215934753},{"id":"https://openalex.org/C194828623","wikidata":"https://www.wikidata.org/wiki/Q2861470","display_name":"Emergency medicine","level":1,"score":0.4302000105381012},{"id":"https://openalex.org/C3020169349","wikidata":"https://www.wikidata.org/wiki/Q45959","display_name":"Adverse drug event","level":3,"score":0.3874000012874603},{"id":"https://openalex.org/C199475168","wikidata":"https://www.wikidata.org/wiki/Q1539689","display_name":"MedDRA","level":4,"score":0.374099999666214},{"id":"https://openalex.org/C545542383","wikidata":"https://www.wikidata.org/wiki/Q2751242","display_name":"Medical emergency","level":1,"score":0.36059999465942383},{"id":"https://openalex.org/C177713679","wikidata":"https://www.wikidata.org/wiki/Q679690","display_name":"Intensive care medicine","level":1,"score":0.3569999933242798},{"id":"https://openalex.org/C535046627","wikidata":"https://www.wikidata.org/wiki/Q30612","display_name":"Clinical trial","level":2,"score":0.3522999882698059},{"id":"https://openalex.org/C143095724","wikidata":"https://www.wikidata.org/wiki/Q515895","display_name":"Odds","level":3,"score":0.3224000036716461},{"id":"https://openalex.org/C2779473830","wikidata":"https://www.wikidata.org/wiki/Q1540899","display_name":"MEDLINE","level":2,"score":0.3059999942779541},{"id":"https://openalex.org/C2780035454","wikidata":"https://www.wikidata.org/wiki/Q8386","display_name":"Drug","level":2,"score":0.3041999936103821},{"id":"https://openalex.org/C4892016","wikidata":"https://www.wikidata.org/wiki/Q2045717","display_name":"Package insert","level":2,"score":0.2992999851703644},{"id":"https://openalex.org/C77088390","wikidata":"https://www.wikidata.org/wiki/Q8513","display_name":"Database","level":1,"score":0.296099990606308},{"id":"https://openalex.org/C23276603","wikidata":"https://www.wikidata.org/wiki/Q158230","display_name":"Pharmacoepidemiology","level":3,"score":0.29019999504089355},{"id":"https://openalex.org/C2779328685","wikidata":"https://www.wikidata.org/wiki/Q1475557","display_name":"Patient safety","level":3,"score":0.27070000767707825},{"id":"https://openalex.org/C151956035","wikidata":"https://www.wikidata.org/wiki/Q1132755","display_name":"Logistic regression","level":2,"score":0.25839999318122864},{"id":"https://openalex.org/C188313352","wikidata":"https://www.wikidata.org/wiki/Q119697","display_name":"Off-label use","level":2,"score":0.2524000108242035},{"id":"https://openalex.org/C195910791","wikidata":"https://www.wikidata.org/wiki/Q1324077","display_name":"Medical record","level":2,"score":0.25040000677108765}],"mesh":[],"locations_count":1,"locations":[{"id":"doi:10.1177/22313354261492930","doi":"https://doi.org/10.1177/22313354261492930","is_oa":true,"landing_page_url":"https://doi.org/10.1177/22313354261492930","pdf_url":null,"source":{"id":"https://openalex.org/S2764844132","display_name":"Journal of Applied Pharmaceutical Science","issn_l":"2231-3354","issn":["2231-3354"],"is_oa":true,"is_in_doaj":false,"is_core":true,"listed_in":["cwts-core","norway-1","poland-40","russia-white-list-2"],"host_organization":"https://openalex.org/P4327876862","host_organization_name":"Open Science Publishers LLP","host_organization_lineage":["https://openalex.org/P4327876862"],"host_organization_lineage_names":["Open Science Publishers LLP"],"type":"journal"},"license":"cc-by-nc","license_id":"https://openalex.org/licenses/cc-by-nc","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Journal of Applied Pharmaceutical Science","raw_type":"journal-article"}],"best_oa_location":{"id":"doi:10.1177/22313354261492930","doi":"https://doi.org/10.1177/22313354261492930","is_oa":true,"landing_page_url":"https://doi.org/10.1177/22313354261492930","pdf_url":null,"source":{"id":"https://openalex.org/S2764844132","display_name":"Journal of Applied Pharmaceutical Science","issn_l":"2231-3354","issn":["2231-3354"],"is_oa":true,"is_in_doaj":false,"is_core":true,"listed_in":["cwts-core","norway-1","poland-40","russia-white-list-2"],"host_organization":"https://openalex.org/P4327876862","host_organization_name":"Open Science Publishers LLP","host_organization_lineage":["https://openalex.org/P4327876862"],"host_organization_lineage_names":["Open Science Publishers LLP"],"type":"journal"},"license":"cc-by-nc","license_id":"https://openalex.org/licenses/cc-by-nc","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Journal of Applied Pharmaceutical Science","raw_type":"journal-article"},"sustainable_development_goals":[],"study_designs":[],"awards":[],"funders":[],"has_content":{"pdf":false,"grobid_xml":false},"content_urls":null,"referenced_works_count":28,"referenced_works":["https://openalex.org/W1992045689","https://openalex.org/W2009890917","https://openalex.org/W2066724335","https://openalex.org/W2070544236","https://openalex.org/W2136616978","https://openalex.org/W2259981268","https://openalex.org/W2472705372","https://openalex.org/W2800811672","https://openalex.org/W2914328670","https://openalex.org/W2932517566","https://openalex.org/W2972823724","https://openalex.org/W3004054176","https://openalex.org/W3037838896","https://openalex.org/W3121914643","https://openalex.org/W4280506043","https://openalex.org/W4309042619","https://openalex.org/W4388132138","https://openalex.org/W4389180457","https://openalex.org/W4390448427","https://openalex.org/W4391261634","https://openalex.org/W4396696102","https://openalex.org/W4408357602","https://openalex.org/W4410481172","https://openalex.org/W4414851591","https://openalex.org/W4416839948","https://openalex.org/W4417263445","https://openalex.org/W7123799921","https://openalex.org/W7130514022"],"related_works":[],"abstract_inverted_index":{"Fentanyl,":[0],"a":[1,213],"potent":[2],"synthetic":[3],"opioid,":[4],"is":[5,224],"widely":[6],"used":[7],"in":[8,63,120,177],"pediatric":[9],"pain":[10],"management,":[11],"for":[12,48,131,172,186,215],"cancer-related":[13],"pain,":[14],"post-surgical":[15],"care,":[16],"and":[17,35,115,136,145,166,189,201,218,233],"palliative":[18],"scenarios.":[19],"Its":[20],"use":[21,112],"carries":[22],"the":[23,46,57,72,121,128,170,197,209],"possibility":[24],"of":[25,40,89,106,175,220,229],"significant":[26],"adverse":[27],"events":[28],"(AEs)":[29],"due":[30],"to":[31,55,81,109,226],"its":[32],"unique":[33],"metabolic":[34],"physiological":[36],"characteristics.":[37],"The":[38],"lack":[39],"pediatric-specific":[41],"clinical":[42,235],"trial":[43],"data":[44],"underscores":[45],"need":[47,171,214],"real-world":[49],"safety":[50,96,183],"information.":[51],"This":[52],"study":[53],"aimed":[54],"evaluate":[56],"AE":[58,69],"profile":[59],"associated":[60,231],"with":[61],"fentanyl":[62,111,176,230],"children":[64],"aged":[65],"0\u201317":[66],"years":[67],"through":[68],"reports":[70,97,107],"from":[71,78,91],"FDA\u2019s":[73],"Adverse":[74],"Event":[75],"Reporting":[76],"System":[77],"Q1":[79],"2004":[80],"Q2":[82],"2024":[83],"using":[84,127,141],"OpenVigil":[85],"2.1.":[86],"After":[87],"deduplication":[88],"14,184":[90],"16,955":[92],"initially":[93],"obtained":[94],"individual":[95],"(ISRs),":[98],"2,771":[99],"ISRs":[100,117],"were":[101,118,125,139,155],"retrieved,":[102],"followed":[103],"by":[104],"exclusion":[105],"unrelated":[108],"therapeutic":[110],"(579":[113],"ISRs),":[114],"2,192":[116,150],"included":[119,160],"final":[122],"analysis.":[123],"AEs":[124,159,232],"classified":[126],"Medical":[129],"Dictionary":[130],"Regulatory":[132],"Activities":[133],"(version":[134],"27.1),":[135],"disproportionality":[137],"analyses":[138],"performed":[140],"reporting":[142,147,219],"odds":[143],"ratios":[144],"proportional":[146],"ratios.":[148],"Among":[149],"reports,137":[151],"preferred":[152],"terms":[153,203],"(PT)":[154],"identified.":[156],"Frequently":[157],"reported":[158],"somnolence,":[161],"neonatal":[162,190],"drug":[163,191],"withdrawal":[164,192],"syndrome,":[165],"respiratory":[167],"depression,":[168],"stressing":[169],"continuous":[173],"monitoring":[174],"children.":[178],"Disproportionality":[179],"analysis":[180],"identified":[181],"88":[182],"signals,":[184],"particularly":[185],"amnestic":[187],"disorder":[188],"syndrome.":[193],"Concordance":[194],"testing":[195],"between":[196],"structured":[198],"product":[199],"label":[200],"OpenVigil-derived":[202],"showed":[204],"only":[205],"6.72%":[206],"agreement":[207],"at":[208],"PT":[210],"level,":[211],"showing":[212],"increased":[216],"identification":[217],"AEs.":[221],"Continuous":[222],"pharmacovigilance":[223],"essential":[225],"improve":[227],"understanding":[228],"enhance":[234],"safety.":[236]},"counts_by_year":[],"updated_date":"2026-11-12T12:28:57.059296","created_date":"2026-11-12T00:00:00"}