Podjanee JittamalaWuelton MonteiroMenno R. SmitBelen PedriqueSabine SpechtCarlos J. ChaccourCéline DardPascal Del GiudiceVirak KhieuAnnabel MaruaniVirgilio E. Failoc-RojasMarimar Sáez-De-ocarizAntoni Soriano-ArandesJaime Piquero-CasalsAnne FaisantMarie Pierre Brenier-PinchartDavid WimmersbergerJean T. CoulibalyJennifer KeiserFranck BoraleviOliver SokanaMichael MarksDaniel EngelmanLucia RomaniAndrew C. SteerLorenz von SeidleinNicholas J. WhiteEli HarrissKasia StepniewskaGeorgina S. HumphreysKalynn KennonPhilippe J. GuerinKevin C. KobylinskiFaculty of Tropical Medicine, Mahidol UniversityHospital Regional LambayequeVall d'Hebron Institut de RecercaUniversidad San Ignacio de LoyolaUniversité de BordeauxMinistry of Health CambodiaUniversity of CocodyCentre Suisse de Recherches Scientifiques AbidjanIfakara Health InstituteEmma KinderziekenhuisUniversidad de NavarraLondon School of Hygiene & Tropical MedicineGreen Templeton CollegeUniversity of OxfordThe Kirby InstituteUniversity of MelbourneUniversitat BaselHospital for Tropical DiseasesCentre Hospitalier Universitaire de BordeauxLiverpool School of Tropical MedicineCentre Hospitalier Regional et Universitaire de ToursArmed Forces Research Institute of Medical Sciences, ThailandMurdoch Children's Research InstituteNuffield Department of MedicineCentre Hospitalier Universitaire de GrenobleInstituto Nacional de PediatríaUniversiteit van AmsterdamUniversidade do Estado do AmazonasUniversitat de BarcelonaCentre Hospitalier de Basse-TerreDrugs for Neglected Diseases initiative (DNDi)Infectious Diseases Data Observatory (IDDO)Solomon Islands Ministry of Health and Medical ServicesDermikCentre Hospitalier Intercommunal de Fréjus-Saint-RaphaëlFundação de Medicina Tropical Dr. Heitor Vieira DouradoWorldWide Antimalarial Resistance Network (WWARN)Centro de Investigação em Saúde de Manhiça2022-08-042022-08-042021-03-01PLoS Neglected Tropical Diseases. Vol.15, No.3 (2021)19352735193527272-s2.0-85103144168https://repository.li.mahidol.ac.th/handle/20.500.14594/78372Background Oral ivermectin is a safe broad spectrum anthelminthic used for treating several neglected tropical diseases (NTDs). Currently, ivermectin use is contraindicated in children weighing less than 15 kg, restricting access to this drug for the treatment of NTDs. Here we provide an updated systematic review of the literature and we conducted an individual-level patient data (IPD) meta-analysis describing the safety of ivermectin in children weighing less than 15 kg. Methodology/Principal findings A systematic review was conducted using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) for IPD guidelines by searching MEDLINE via PubMed, Web of Science, Ovid Embase, LILACS, Cochrane Database of Systematic Reviews, TOXLINE for all clinical trials, case series, case reports, and database entries for reports on the use of ivermectin in children weighing less than 15 kg that were published between 1 January 1980 to 25 October 2019. The protocol was registered in the International Prospective Register of Systematic Reviews (PROSPERO): CRD42017056515. A total of 3,730 publications were identified, 97 were selected for potential inclusion, but only 17 sources describing 15 studies met the minimum criteria which consisted of known weights of children less than 15 kg linked to possible adverse events, and provided comprehensive IPD. A total of 1,088 children weighing less than 15 kg were administered oral iver-mectin for one of the following indications: scabies, mass drug administration for scabies control, crusted scabies, cutaneous larva migrans, myiasis, pthiriasis, strongyloidiasis, tri-churiasis, and parasitic disease of unknown origin. Overall a total of 1.4% (15/1,088) of children experienced 18 adverse events all of which were mild and self-limiting. No serious adverse events were reported. Conclusions/Significance Existing limited data suggest that oral ivermectin in children weighing less than 15 kilograms is safe. Data from well-designed clinical trials are needed to provide further assurance.Mahidol UniversityMedicineArticleSCOPUS10.1371/journal.pntd.0009144