Home Contact Sitemap

PedAM

Pediatric Disease Annotations & Medicines



   liver failure, acute
  

Disease ID 1633
Disease liver failure, acute
Synonym
acute failure hepatic
acute failure liver
acute hepatic failure
acute hepatic failure (disorder)
acute liver failure
alf - acute liver failure
failure hepatic acute
failure, acute hepatic
failure, acute liver
fhf - fulminant hepatic failure
fulminant hepatic failure
fulminant hepatic failure (disorder)
fulminant hepatic failures
fulminant liver failure
fulminant liver failures
fulminate liver failure
fulminating hepatic failure
fulminating hepatic failures
fulminating liver failure
fulminating liver failures
hepatic failure - acute
hepatic failure, acute
hepatic failure, fulminant
hepatic failure, fulminating
hepatic failures, fulminant
hepatic failures, fulminating
hepatic fulminant failure
liver acute failure alf
liver failure, acute [disease/finding]
liver failure, fulminant
liver failure, fulminating
liver failures, fulminant
liver failures, fulminating
Orphanet
MeSH
SNOMED-CT
Comorbidity
UMLS | Disease | Sentences' Count(Total Sentences:83)
C0019158  |  hepatitis  |  25
C0019151  |  hepatic encephalopathy  |  24
C1527311  |  brain edema  |  8
C0023890  |  cirrhosis  |  8
C0019163  |  hepatitis b  |  8
C0085293  |  hepatitis e  |  7
C0023895  |  liver disease  |  5
C0042721  |  viral hepatitis  |  5
C0019147  |  hepatic coma  |  4
C0019202  |  wilson disease  |  4
C0002871  |  anemia  |  3
C0001125  |  lactic acidosis  |  3
C0019196  |  hepatitis c  |  3
C0042769  |  virus infection  |  3
C0019100  |  dengue haemorrhagic fever  |  2
C0268542  |  ornithine transcarbamylase deficiency  |  2
C0040127  |  thyroid storm  |  2
C0019204  |  hepatocellular carcinoma  |  2
C0024299  |  lymphoma  |  2
C0042769  |  viral infection  |  2
C0006142  |  breast cancer  |  2
C0020550  |  hyperthyroidism  |  1
C0020538  |  hypertension  |  1
C0023448  |  lymphoblastic leukemia  |  1
C0079774  |  peripheral t-cell lymphoma  |  1
C0023891  |  alcoholic liver cirrhosis  |  1
C0040156  |  thyrotoxicosis  |  1
C0023434  |  chronic lymphocytic leukemia  |  1
C0042769  |  viral infections  |  1
C0018801  |  heart failure  |  1
C0002874  |  aplastic anemia  |  1
C0878544  |  cardiomyopathy  |  1
C0410528  |  skeletal dysplasia  |  1
C0023895  |  hepatocellular disease  |  1
C0036472  |  scrub typhus  |  1
C0019829  |  hodgkin's disease  |  1
C0018801  |  cardiac failure  |  1
C0023895  |  liver disorders  |  1
C0879615  |  stromal tumor  |  1
C0019829  |  hodgkin lymphoma  |  1
C0041296  |  tuberculosis  |  1
C0032285  |  pneumonia  |  1
C0151740  |  elevated intracranial pressure  |  1
C0009492  |  compartment syndrome  |  1
C0019100  |  dengue hemorrhagic fever  |  1
C0085273  |  parvovirus b19 infection  |  1
C0002726  |  amyloidosis  |  1
C0019212  |  hepatorenal syndrome  |  1
C0023890  |  liver cirrhosis  |  1
C0041471  |  typhus  |  1
C0687720  |  neurogenic diabetes insipidus  |  1
C0027708  |  wilms tumor  |  1
C0013990  |  emphysema  |  1
C0019163  |  hepatitis b infection  |  1
C0281963  |  red cell aplasia  |  1
C0023364  |  leptospirosis  |  1
C0001623  |  adrenal insufficiency  |  1
C0015230  |  rash  |  1
C0023418  |  leukemia  |  1
C1619734  |  pulmonary arterial hypertension  |  1
C0006112  |  metabolic encephalopathy  |  1
C0042384  |  vasculitis  |  1
C0021345  |  mononucleosis  |  1
C0011847  |  diabetes  |  1
C0023895  |  liver diseases  |  1
C0023467  |  acute myeloid leukemia  |  1
C0151295  |  mononeuritis multiplex  |  1
C0042721  |  virus hepatitis  |  1
C0034902  |  pure red cell aplasia  |  1
C0021053  |  immune disease  |  1
C0002895  |  sickle cell anemia  |  1
C0334277  |  metastatic adenocarcinoma  |  1
C0038041  |  spotted fever  |  1
C0023449  |  acute lymphoblastic leukemia  |  1
C0282193  |  iron overload  |  1
C0021345  |  infectious mononucleosis  |  1
C0035920  |  rubella  |  1
C0041327  |  pulmonary tuberculosis  |  1
C0023895  |  liver disorder  |  1
C1565489  |  renal insufficiency  |  1
C0011848  |  diabetes insipidus  |  1
C0006413  |  burkitt lymphoma  |  1
C0023448  |  lymphocytic leukemia  |  1
Curated Gene
Entrez_id | Symbol | Resource(Total Genes:22)
INS  |  3630  |  CTD_human
TNF  |  7124  |  CTD_human
POMC  |  5443  |  CTD_human
FAS  |  355  |  CTD_human
GC  |  2638  |  CTD_human
CAST  |  831  |  CTD_human
ALB  |  213  |  CTD_human
ATP7B  |  540  |  CTD_human
CSF3  |  1440  |  CTD_human
HGF  |  3082  |  CTD_human
IL1RN  |  3557  |  CTD_human
FST  |  10468  |  CTD_human
FASLG  |  356  |  CTD_human
SERPINC1  |  462  |  CTD_human
GFER  |  2671  |  CTD_human
KRT8  |  3856  |  CTD_human
SCO1  |  6341  |  CTD_human
GPNMB  |  10457  |  CTD_human
MAPK8  |  5599  |  CTD_human
CD74  |  972  |  CTD_human
INHBA  |  3624  |  CTD_human
KRT18  |  3875  |  CTD_human
Inferring Gene
Entrez_id | Symbol | Resource(Total Genes:1)
7124  |  TNF  |  infer
Text Mined Gene(Waiting for update.)
Locus(Waiting for update.)
Disease ID 1633
Disease liver failure, acute
Integrated Phenotype(Waiting for update.)
Text Mined Phenotype
HPO | Name | Sentences' Count(Total Phenotypes:69)
HP:0001298  |  Encephalopathy  |  31
HP:0012115  |  Liver inflammation  |  25
HP:0002480  |  Hepatic encephalopathy  |  24
HP:0002181  |  Cerebral edema  |  12
HP:0000969  |  Dropsy  |  12
HP:0003256  |  Coagulopathy  |  8
HP:0001394  |  Hepatic cirrhosis  |  8
HP:0001259  |  Coma  |  6
HP:0001399  |  Liver failure  |  5
HP:0001919  |  Acute renal failure  |  5
HP:0200123  |  Chronic liver inflammation  |  4
HP:0006562  |  Viral hepatitis  |  4
HP:0003128  |  Lactic acidosis  |  3
HP:0200119  |  Acute liver inflammation  |  3
HP:0002045  |  Abnormally low body temperature  |  3
HP:0001903  |  Anemia  |  3
HP:0001928  |  Abnormal blood coagulation studies  |  2
HP:0200084  |  Giant cell hepatitis  |  2
HP:0001397  |  Hepatic steatosis  |  2
HP:0001987  |  Hyperammonemia  |  2
HP:0003002  |  Breast carcinoma  |  2
HP:0100806  |  Sepsis  |  2
HP:0002605  |  Hepatic necrosis  |  2
HP:0001635  |  Congestive heart failure  |  2
HP:0002665  |  Lymphoma  |  2
HP:0001945  |  Fever  |  2
HP:0001402  |  Hepatocellular carcinoma  |  2
HP:0004808  |  Acute myelogenous leukemia  |  1
HP:0001410  |  Decreased liver function  |  1
HP:0001541  |  Ascites  |  1
HP:0000083  |  Renal insufficiency  |  1
HP:0005110  |  Atrial fibrillation  |  1
HP:0003201  |  Rhabdomyolysis  |  1
HP:0012190  |  T cell lymphoma  |  1
HP:0000873  |  Diabetes insipidus  |  1
HP:0000836  |  Overactive thyroid  |  1
HP:0012189  |  Hodgkin disease  |  1
HP:0000846  |  Hypoadrenalism  |  1
HP:0011029  |  Internal bleeding  |  1
HP:0011034  |  Amyloid disease  |  1
HP:0001941  |  acidemia  |  1
HP:0030080  |  Burkitt lymphoma  |  1
HP:0002904  |  High blood bilirubin levels  |  1
HP:0000708  |  Behavioral problems  |  1
HP:0002721  |  Immunodeficiency  |  1
HP:0001638  |  Cardiomyopathy  |  1
HP:0002664  |  Neoplasia  |  1
HP:0001250  |  Seizures  |  1
HP:0012410  |  Pure red cell aplasia  |  1
HP:0012378  |  Fatigue  |  1
HP:0001297  |  Cerebral vascular events  |  1
HP:0004947  |  Arteriovenous fistula  |  1
HP:0040187  |  Neonatal sepsis  |  1
HP:0002960  |  Autoimmune condition  |  1
HP:0012531  |  Pain  |  1
HP:0004900  |  Severe lactic acidosis  |  1
HP:0006721  |  Acute lymphocytic leukemia  |  1
HP:0002667  |  Wilms tumor  |  1
HP:0002090  |  Pneumonia  |  1
HP:0000822  |  Hypertension  |  1
HP:0002633  |  Vasculitis  |  1
HP:0002625  |  Blood clot in a deep vein  |  1
HP:0002615  |  Low blood pressure  |  1
HP:0030731  |  Carcinoma  |  1
HP:0002148  |  Hypophosphataemia  |  1
HP:0001909  |  Leukemia  |  1
HP:0005550  |  Chronic lymphatic leukemia  |  1
HP:0001915  |  Aplastic anemia  |  1
HP:0002652  |  Skeletal dysplasia  |  1
Disease ID 1633
Disease liver failure, acute
Manually Symptom(Waiting for update.)
Text Mined Symptom
UMLS | Name | Sentences' Count(Total Symptoms:14)
C0085584  |  encephalopathy  |  29
C0019151  |  hepatic encephalopathy  |  22
C1527311  |  brain edema  |  8
C0005779  |  coagulopathy  |  6
C0019202  |  wilson disease  |  4
C0019158  |  hepatitis  |  4
C0948600  |  organ failure  |  3
C0020672  |  hypothermia  |  3
C0042769  |  virus infection  |  2
C0009450  |  infection  |  2
C0023907  |  liver regeneration  |  1
C0011847  |  diabetes  |  1
C0020649  |  hypotension  |  1
C0019270  |  herniation  |  1
Manually Genotype(Total Text Mining Genotypes:0)
(Waiting for update.)
All Snps(Total Genotypes:1)
snpId pubmedId geneId geneSymbol diseaseId sourceId sentence score Year geneSymbol_dbSNP CHROMOSOME POS REF ALT
rs83302340811654658UGT1A1umls:C0162557BeFreeThe UDP-glucuronosyltransferase (UGT) 1A polymorphism c.2042C>G (rs8330) is associated with increased human liver acetaminophen glucuronidation, increased UGT1A exon 5a/5b splice variant mRNA ratio, and decreased risk of unintentional acetaminophen-induced acute liver failure.0.0002714422013UGT1A10;UGT1A8;UGT1A7;UGT1A6;UGT1A5;UGT1A9;UGT1A4;UGT1A1;UGT1A32233772999GC
GWASdb Annotation(Total Genotypes:0)
(Waiting for update.)
GWASdb Snp Trait(Total Genotypes:0)
(Waiting for update.)
Mapped by lexical matching(Total Items:0)
(Waiting for update.)
Mapped by homologous gene(Total Items:0)
(Waiting for update.)
Chemical(Total Drugs:49)
CUI ChemicalName ChemicalID CasRN DiseaseName DiseaseID DirectEvidence PubMedIDs
C0162557acarboseD02090956180-94-0liver failure, acuteMESH:D017114marker/mechanism18648179
C0162557acetaminophenD000082103-90-2liver failure, acuteMESH:D017114marker/mechanism10212046
C0162557acetylcysteineD000111616-91-1liver failure, acuteMESH:D017114therapeutic10919033
C0162557caffeineD0021101958/8/2liver failure, acuteMESH:D017114therapeutic22154906
C0162557carbamazepineD002220298-46-4liver failure, acuteMESH:D017114marker/mechanism16033627
C0162557celecoxibD000068579-liver failure, acuteMESH:D017114marker/mechanism19701976
C0162557chlorambucilD002699305-03-3liver failure, acuteMESH:D017114marker/mechanism10922320
C0162557chlorzoxazoneD00275395-25-0liver failure, acuteMESH:D017114marker/mechanism17390222
C0162557ciprofloxacinD00293985721-33-1liver failure, acuteMESH:D017114marker/mechanism12399240
C0162557clozapineD0030245786-21-0liver failure, acuteMESH:D017114marker/mechanism10950478
C0162557colchicineD00307864-86-8liver failure, acuteMESH:D017114marker/mechanism15088997
C0162557cyclophosphamideD00352050-18-0liver failure, acuteMESH:D017114marker/mechanism19008178
C0162557cyclosporineD01657259865-13-3liver failure, acuteMESH:D017114marker/mechanism11757752
C0162557diclofenacD00400815307-86-5liver failure, acuteMESH:D017114marker/mechanism11204815
C0162557doxycyclineD004318564-25-0liver failure, acuteMESH:D017114marker/mechanism19539102
C0162557enalaprilD00465675847-73-3liver failure, acuteMESH:D017114marker/mechanism11141678
C0162557entecavirC413685-liver failure, acuteMESH:D017114therapeutic21186528
C0162557flutamideD00548513311-84-7liver failure, acuteMESH:D017114marker/mechanism10215102
C0162557imatinib mesylateD000068877-liver failure, acuteMESH:D017114marker/mechanism18161937
C0162557imipramineD00709950-49-7liver failure, acuteMESH:D017114marker/mechanism2315196
C0162557lamotrigineC04778184057-84-1liver failure, acuteMESH:D017114marker/mechanism17923349
C0162557lenalidomideC467567-liver failure, acuteMESH:D017114marker/mechanism20011646
C0162557metforminD008687657-24-9liver failure, acuteMESH:D017114marker/mechanism12639207
C0162557methotrexateD0087271959/5/2liver failure, acuteMESH:D017114marker/mechanism20141060
C0162557methoxsalenD008730298-81-7liver failure, acuteMESH:D017114marker/mechanism8308218
C0162557mirtazapineC035133-liver failure, acuteMESH:D017114marker/mechanism16797245
C0162557modafinilC04883368693-11-8liver failure, acuteMESH:D017114marker/mechanism16045030
C0162557nevirapineD019829129618-40-2liver failure, acuteMESH:D017114marker/mechanism15213559
C0162557nortriptylineD00966172-69-5liver failure, acuteMESH:D017114marker/mechanism7884180
C0162557ofloxacinD01524282419-36-1liver failure, acuteMESH:D017114marker/mechanism11580158
C0162557omeprazoleD00985373590-58-6liver failure, acuteMESH:D017114marker/mechanism1553942
C0162557phenytoinD01067257-41-0liver failure, acuteMESH:D017114marker/mechanism10915174
C0162557piroxicamD01089436322-90-4liver failure, acuteMESH:D017114marker/mechanism12185885
C0162557propylthiouracilD01144151-52-5liver failure, acuteMESH:D017114marker/mechanism12645809
C0162557epoprostenolD01146435121-78-9liver failure, acuteMESH:D017114therapeutic15633222
C0162557pyrazinamideD01171898-96-4liver failure, acuteMESH:D017114marker/mechanism12006469
C0162557rifampinD01229313292-46-1liver failure, acuteMESH:D017114marker/mechanism12006469
C0162557ritonavirD019438-liver failure, acuteMESH:D017114marker/mechanism9786823
C0162557rosiglitazoneC089730-liver failure, acuteMESH:D017114marker/mechanism18397974
C0162557sorafenibC471405-liver failure, acuteMESH:D017114marker/mechanism18796127
C0162557tenofovirD000068698-liver failure, acuteMESH:D017114marker/mechanism16176639
C0162557thalidomideD01379250-35-1liver failure, acuteMESH:D017114marker/mechanism17493431
C0162557thiopentalD01387476-75-5liver failure, acuteMESH:D017114marker/mechanism16116121
C0162557tolcaponeC066340134308-13-7liver failure, acuteMESH:D017114marker/mechanism11052337
C0162557topiramateC05234297240-79-4liver failure, acuteMESH:D017114marker/mechanism10915174
C0162557tramadolD01414727203-92-5liver failure, acuteMESH:D017114marker/mechanism12850423
C0162557troglitazoneC05769397322-87-7liver failure, acuteMESH:D017114marker/mechanism10685776
C0162557valproic acidD01463599-66-1liver failure, acuteMESH:D017114marker/mechanism10403231
C0162557vancomycinD0146401404-90-6liver failure, acuteMESH:D017114marker/mechanism19706026
FDA approved drug and dosage information(Total Drugs:36)
DiseaseID Drug_name active_ingredients strength Dosage Form/Route Marketing Status TE code RLD RS
MESH:D017114prilosecomeprazole20MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasonsCAPSULE, DELAYED REL PELLETS;ORALDiscontinuedNoneYesNo
MESH:D017114prilosecomeprazole20MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasonsCAPSULE, DELAYED REL PELLETS;ORALDiscontinuedNoneYesNo
MESH:D017114omeprazoleomeprazole20MGTABLET, DELAYED RELEASE;ORALOver-the-counterNoneYesYes
MESH:D017114omeprazoleomeprazole20MGTABLET, DELAYED RELEASE;ORALOver-the-counterNoneYesYes
MESH:D017114lamictallamotrigine100MGTABLET;ORALPrescriptionABYesNo
MESH:D017114lamictallamotrigine100MGTABLET;ORALPrescriptionABYesNo
MESH:D017114lamictallamotrigine100MGTABLET;ORALPrescriptionABYesNo
MESH:D017114lamictal xrlamotrigine25MGTABLET, EXTENDED RELEASE;ORALPrescriptionABYesNo
MESH:D017114lamictal xrlamotrigine25MGTABLET, EXTENDED RELEASE;ORALPrescriptionABYesNo
MESH:D017114lamictal xrlamotrigine25MGTABLET, EXTENDED RELEASE;ORALPrescriptionABYesNo
MESH:D017114ciprociprofloxacin400MG/40ML (10MG/ML)INJECTABLE;INJECTIONDiscontinuedNoneYesNo
MESH:D017114ciprociprofloxacin250MG/5MLFOR SUSPENSION;ORALPrescriptionABYesNo
MESH:D017114remeronmirtazapine15MGTABLET;ORALPrescriptionABYesYes
MESH:D017114norvirritonavir80MG/MLSOLUTION;ORALPrescriptionNoneYesYes
MESH:D017114norvirritonavir100MGCAPSULE;ORALDiscontinuedNoneNoNo
MESH:D017114norvirritonavir100MGCAPSULE;ORALPrescriptionNoneYesYes
MESH:D017114norvirritonavir100MGTABLET;ORALPrescriptionABYesYes
MESH:D017114gleevecimatinib mesylateEQ 50MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasonsCAPSULE;ORALDiscontinuedNoneYesNo
MESH:D017114gleevecimatinib mesylateEQ 100MG BASETABLET;ORALPrescriptionABYesNo
MESH:D017114celebrexcelecoxib100MGCAPSULE;ORALPrescriptionABYesNo
MESH:D017114celebrexcelecoxib100MGCAPSULE;ORALPrescriptionNoneNoNo
MESH:D017114provigilmodafinil100MGTABLET;ORALPrescriptionABYesNo
MESH:D017114topamaxtopiramate100MGTABLET;ORALPrescriptionABYesYes
MESH:D017114topamaxtopiramate15MGCAPSULE;ORALPrescriptionABYesNo
MESH:D017114topamaxtopiramate100MGTABLET;ORALPrescriptionABYesYes
MESH:D017114topamaxtopiramate15MGCAPSULE;ORALPrescriptionABYesNo
MESH:D017114topamaxtopiramate100MGTABLET;ORALPrescriptionABYesYes
MESH:D017114topamaxtopiramate15MGCAPSULE;ORALPrescriptionABYesNo
MESH:D017114topamaxtopiramate100MGTABLET;ORALPrescriptionABYesYes
MESH:D017114topamaxtopiramate15MGCAPSULE;ORALPrescriptionABYesNo
MESH:D017114ofirmevacetaminophen1GM/100ML (10MG/ML)SOLUTION;IV (INFUSION)PrescriptionAPYesYes
MESH:D017114ofirmevacetaminophen1GM/100ML (10MG/ML)SOLUTION;IV (INFUSION)PrescriptionAPYesYes
MESH:D017114acetaminophenacetaminophen650MGSUPPOSITORY;RECTALOver-the-counterNoneYesYes
MESH:D017114acetaminophenacetaminophen650MGSUPPOSITORY;RECTALOver-the-counterNoneYesYes
MESH:D017114baracludeentecavir0.5MGTABLET;ORALPrescriptionABYesNo
MESH:D017114baracludeentecavir0.05MG/MLSOLUTION;ORALPrescriptionNoneYesYes
FDA labeling changes(Total Drugs:36)
DiseaseID Pediatric_Labeling_Date Trade_Name Generic_Name_or_Proper_Name Indications Studied Label Changes Summary Product Labeling BPCA(B) PREA(P) BPCA(B) and PREA(P) Pediatric Rule (R) Sponsor Pediatric Exclusivity Granted Date NNPS
MESH:D01711412/7/2002prilosecomeprazoleGastroesophageal reflux and erosive esophagitisSafety and effectiveness established in pediatric patients 2-16 years of age Information on dose, PK parameters, exposure/response and AE profileLabelingB---AstraZeneca-FALSE'
MESH:D01711403/20/2008prilosecomeprazoleMaintenance healing of erosive esophagitisEfficacy was extrapolated from adults and older children to 1 to 2 year olds and supported with an open-label trial Unique adverse reactions in pediatric patients included increased respiratory system adverse events and fever. Safety and effectiveness in children less than 1 year of age have not been established Dosing and administration information provided for patients 1 year and older weighing at least 5 kg. New dosage formLabeling--B, P-AstraZeneca1/5/2001FALSE'
MESH:D01711412/7/2002prilosecomeprazoleGastroesophageal reflux and erosive esophagitisSafety and effectiveness established in pediatric patients 2-16 years of age Information on dose, PK parameters, exposure/response and AE profileLabelingB---AstraZeneca-FALSE'
MESH:D01711403/20/2008prilosecomeprazoleMaintenance healing of erosive esophagitisEfficacy was extrapolated from adults and older children to 1 to 2 year olds and supported with an open-label trial Unique adverse reactions in pediatric patients included increased respiratory system adverse events and fever. Safety and effectiveness in children less than 1 year of age have not been established Dosing and administration information provided for patients 1 year and older weighing at least 5 kg. New dosage formLabeling--B, P-AstraZeneca1/5/2001FALSE'
MESH:D01711401/17/2003lamictallamotrigineAdjunctive therapy for partial seizuresExtended indication from adults to pediatric patients e 2 years Patients aged 2 - 18 years had clearance influenced predominantly by total body weight and concurrent antiepileptic drug (AED) therapy. The oral clearance was higher, on a body weight basis, in pediatric patients than in adults Because of increased clearance in pediatrics, maintenance doses in patients weighing < 30 kg may need an increase of as much as 50% based upon clinical response Evidence shows that the inclusion of VPA in a multi-drug regimen increases the risk of serious, potentially life-threatening rash in pediatric patients Approximately 11.5% of the 1,081 pediatric patients who received the drug as adjunctive therapy in clinical trials discontinued treatment because of an AELabelingB---GlaxoSmithKline02/14/2007FALSE'
MESH:D0171148/5/2009lamictallamotrigineAdjunctive treatment for partial seizures in pediatric patients 1  24 monthsSafety and effectiveness as adjunctive treatment for partial seizures were not demonstrated in a small randomized, double-blind, placebo-controlled, withdrawal study in pediatric patients 1 - 24 months Immediate release tablets were associated with an increased risk for infectious adverse reactions including bronchiolitis, bronchitis, ear infection, eye infection, otitis externa, pharyngitis, urinary tract infection, and viral infection (Lamictal 37%, Placebo 5%), and respiratory adverse reactions including nasal congestion, cough, and apnea. (Lamictal 26%, Placebo 5%)LabelingB---GlaxoSmithKline02/14/2007FALSE'
MESH:D01711405/18/2015lamictallamotrigineMaintenance treatment of bipolar disorder Safety and efficacy for the maintenance treatment of bipolar disorder were not established in a double-blind, placebo-controlled trial that evaluated 301 pediatric patients aged 10 to 17 Information on clinical trial and adverse reactions Postmarketing studyLabeling-P--GlaxoSmithKline-FALSE
MESH:D01711405/29/2009lamictal xrlamotrigineAdjunctive therapy for partial onset seizures in patients e13 years of ageExtended release tablets are indicated as adjunctive therapy for partial onset seizures with or without secondary generalization in patients e13 years Safety and effectiveness of extended release tablets for any use in patients below the age of 13 have not been established Information on adverse event profile, and clinical studies New dosage formLabeling-P--GlaxoSmithKline-FALSE'
MESH:D01711401/29/2010lamictal xrlamotrigineAdjunctive therapy for Primary Generalized Tonic-Clonic seizuresNew indication for adjunctive therapy for primary generalized tonic-clonic seizures in patients e 13 years of age Safety and effectiveness for any use in patients < 13 years have not been established Information on dosing, adverse reactions, and clinical studiesLabeling-P--GlaxoSmithKline-FALSE'
MESH:D01711404/25/2011lamictal xrlamotrigineMonotherapy in patients 13 years of age and older with partial seizures who are receiving therapy with a single antiepileptic drug (AED)Approved for conversion to monotherapy in patients e13 years of age with partial seizures receiving treatment with a single antiepileptic drug (AED).Safety and effectiveness have not been established (1) as initial monotherapy or (2) for simultaneous conversion to monotherapy from two or more concomitant AEDsInformation on conversion to monotherapy, adverse reactions, clinical trialNew indicationLabeling-P--GlaxoSmithKline-FALSE'
MESH:D01711403/25/2004ciprociprofloxacinComplicated UTI and pyelonephritisIndicated for the treatment of complicated urinary tract infections (cUTIs) and pyelonephritis in pediatric patients 1  17 years of age Not drug of first choice due to increased adverse events compared to controls including events related to joints and/or surrounding tissues Information on PK and dose in pediatric patients 1  17 years of age The most frequent adverse events observed within 6 weeks of treatment initiation during the cUTI clinical trial were gastrointestinal 15% compared to 9% and musculoskeletal 9.3% compared to 6% in ciprofloxacin-treated compared to control-treated patients, respectivelyLabelingB---Bayer12/18/2003FALSE'
MESH:D01711403/25/2004ciprociprofloxacinComplicated UTI and pyelonephritisIndicated for the treatment of complicated urinary tract infections (cUTIs) and pyelonephritis in pediatric patients 1  17 years of age Not drug of first choice due to increased adverse events compared to controls including events related to joints and/or surrounding tissues Information on PK and dose in pediatric patients 1  17 years of age The most frequent adverse events observed within 6 weeks of treatment initiation during the cUTI clinical trial were gastrointestinal 15% compared to 9% and musculoskeletal 9.3% compared to 6% in ciprofloxacin-treated compared to control-treated patients, respectivelyLabelingB---Bayer12/18/2003FALSE'
MESH:D01711412/1/2005remeronmirtazapineMajor Depressive DisorderSafety and effectiveness in the pediatric population have not been established FDA required boxed warning for all antidepressants: Suicidality in Children and Adolescents - Antidepressants increased the risk of suicidal thinking and behavior (suicidality) in short-term studies in children and adolescents with Major Depressive Disorder (MDD) and other psychiatric disorders. Anyone considering the use of Remeron or any other antidepressant in a child or adolescent must balance this risk with the clinical need. Patients who are started on therapy should be observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Remeron is not approved for use in pediatric patients. (See Warnings and Precautions: Pediatric Use) Pooled analyses of short-term (4 to 16 weeks) placebo-controlled trials of 9 antidepressant drugs (SSRIs and others) in children and adolescents with major depressive disorder (MDD), obsessive compulsive disorder (OCD), or other psychiatric disorders (a total of 24 trials involving over 4400 patients) have revealed a greater risk of adverse events representing suicidal thinking or behavior (suicidality) during the first few months of treatment in those receiving antidepressants. The average risk of such events in patients receiving antidepressants was 4%, twice the placebo risk of 2%. No suicides occurred in these trials Two placebo-controlled trials in 258 pediatric patients with MDD have been conducted with Remeron and the data were not sufficient to support a claim for use in pediatric patientsLabelingB---Organon-FALSE'
MESH:D0171146/10/2005norvirritonavirTreatment of HIV-infection in combination with other antiretroviral agentsExtended age range from 2 years down to 1 month AE profile in the pediatric population was similar to that for adults Information on dose and PK parametersLabelingB---Abbott06/14/2005FALSE'
MESH:D0171146/10/2005norvirritonavirTreatment of HIV-infection in combination with other antiretroviral agentsExtended age range from 2 years down to 1 month AE profile in the pediatric population was similar to that for adults Information on dose and PK parametersLabelingB---Abbott06/14/2005FALSE'
MESH:D0171146/10/2005norvirritonavirTreatment of HIV-infection in combination with other antiretroviral agentsExtended age range from 2 years down to 1 month AE profile in the pediatric population was similar to that for adults Information on dose and PK parametersLabelingB---Abbott06/14/2005FALSE'
MESH:D0171146/10/2005norvirritonavirTreatment of HIV-infection in combination with other antiretroviral agentsExtended age range from 2 years down to 1 month AE profile in the pediatric population was similar to that for adults Information on dose and PK parametersLabelingB---Abbott06/14/2005FALSE'
MESH:D01711409/27/2006gleevecimatinib mesylateTreatment of newly diagnosed pediatric patients with Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phaseExtended age range for the treatment of newly diagnosed CML down to pediatric patients There are no data in children < 2 years of age Follow-up in children with newly diagnosed Ph+ chronic phase CML is limited Information on hematologic toxicities, AE profile, clinical studies and dosing guidelines new for newly diagnosed pediatric patientsLabeling--B, P-Novartis9/6/2006FALSE'
MESH:D01711409/27/2006gleevecimatinib mesylateTreatment of newly diagnosed pediatric patients with Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phaseExtended age range for the treatment of newly diagnosed CML down to pediatric patients There are no data in children < 2 years of age Follow-up in children with newly diagnosed Ph+ chronic phase CML is limited Information on hematologic toxicities, AE profile, clinical studies and dosing guidelines new for newly diagnosed pediatric patientsLabeling--B, P-Novartis9/6/2006FALSE'
MESH:D01711412/15/2006celebrexcelecoxibRelief of the signs and symptoms of juvenile rheumatoid arthritis (JRA)New indication in 2 years and older Has not been studied in patients < 2 years, in patients with body weight < 10 kg, or in patients with active systemic features Celecoxib should be used only with caution in patients with systemic onset JRA due to the risk for serious adverse reactions including the risk of disseminated intravascular coagulation The long-term cardiovascular toxicity in children has not been evaluated; it is unknown if the long-term risk may be similar to that seen in adults New 50 mg capsule developed Information on adding contents of a capsule to applesauce. for patients with difficulty swallowing capsules Information on dose, clinical studies, PK parameters, AEsLabelingB---Pfizer08/23/2006FALSE'
MESH:D01711412/15/2006celebrexcelecoxibRelief of the signs and symptoms of juvenile rheumatoid arthritis (JRA)New indication in 2 years and older Has not been studied in patients < 2 years, in patients with body weight < 10 kg, or in patients with active systemic features Celecoxib should be used only with caution in patients with systemic onset JRA due to the risk for serious adverse reactions including the risk of disseminated intravascular coagulation The long-term cardiovascular toxicity in children has not been evaluated; it is unknown if the long-term risk may be similar to that seen in adults New 50 mg capsule developed Information on adding contents of a capsule to applesauce. for patients with difficulty swallowing capsules Information on dose, clinical studies, PK parameters, AEsLabelingB---Pfizer08/23/2006FALSE'
MESH:D01711408/17/2007provigilmodafinilNarcolepsyModafinil is not approved for use in pediatric patients for any indication Safety and effectiveness were not demonstrated in a controlled 6-week study in 165 pediatric patients 5-17 years with narcolepsy Serious rash, including Stevens-Johnson Syndrome, requiring hospitalization and discontinuation of treatment has been reported in adults and children in association with the use of modafinil In the controlled and open-label clinical studies, treatment emergent adverse events of the psychiatric and nervous system included Tourettes syndrome, insomnia, hostility, increased cataplexy, increased hypnagogic hallucinations and suicidal ideation Information on safety, AEs and clinical studyLabelingB---Cephalon, Inc03/21/2006FALSE'
MESH:D01711412/22/2009topamaxtopiramateMigraine ProphylaxisSafety and effectiveness for migraine prevention in pediatric patients have not been established Dose-related increased shift in serum creatinine in adolescent patients occurred in a clinical study Information added to Warnings and Precautions and Pediatric UseLabeling-P--Ortho-McNeil-Janssen-FALSE'
MESH:D01711412/22/2009topamaxtopiramateMigraine ProphylaxisSafety and effectiveness for migraine prevention in pediatric patients have not been established Dose-related increased shift in serum creatinine in adolescent patients occurred in a clinical study Information added to Warnings and Precautions and Pediatric UseLabeling-P--Ortho-McNeil-Janssen-FALSE'
MESH:D01711412/22/2009topamaxtopiramateAdjunctive Treatment for Partial Onset Epilepsy in Infants and Toddlers 1 to 24 monthsEffectiveness was not demonstrated as adjunctive therapy in a randomized, double-blind trial in infants/toddlers 1 to 24 months of age with refractory partial onset seizures Trials in infants/toddlers 1 to 24 months suggested some adverse reactions/toxicities not previously observed in older pediatric patients and adults; i.e, growth/length retardation, certain clinical laboratory abnormalities, and other adverse reactions/toxicities that occurred with a greater frequency and/or greater severity than had been recognized previously from studies in older pediatric patients or adults for various indications. Information added to Warnings and Precautions and Pediatric UseLabelingB---Ortho-McNeil-Janssen07/24/2008FALSE'
MESH:D01711412/22/2009topamaxtopiramateAdjunctive Treatment for Partial Onset Epilepsy in Infants and Toddlers 1 to 24 monthsEffectiveness was not demonstrated as adjunctive therapy in a randomized, double-blind trial in infants/toddlers 1 to 24 months of age with refractory partial onset seizures Trials in infants/toddlers 1 to 24 months suggested some adverse reactions/toxicities not previously observed in older pediatric patients and adults; i.e, growth/length retardation, certain clinical laboratory abnormalities, and other adverse reactions/toxicities that occurred with a greater frequency and/or greater severity than had been recognized previously from studies in older pediatric patients or adults for various indications. Information added to Warnings and Precautions and Pediatric UseLabelingB---Ortho-McNeil-Janssen07/24/2008FALSE'
MESH:D01711407/15/2011topamaxtopiramateMonotherapy for partial onset or primary generalized tonic-clonic seizuresExpanded age range down to 2 years; previously approved for monotherapy for partial onset or primary generalized tonic-clonic seizures in patients10 years and older Information on weight based dosing in 2 to < 10 yearsPostmarketing studyLabeling-P--Janssen-FALSE'
MESH:D01711407/15/2011topamaxtopiramateMonotherapy for partial onset or primary generalized tonic-clonic seizuresExpanded age range down to 2 years; previously approved for monotherapy for partial onset or primary generalized tonic-clonic seizures in patients10 years and older Information on weight based dosing in 2 to < 10 yearsPostmarketing studyLabeling-P--Janssen-FALSE'
MESH:D01711403/28/2014topamaxtopiramateProphylaxis of migraine headacheApproved for use in pediatric patients 12 years and older Safety and effectiveness in pediatric patients less than12 years have not been established for the prophylaxis treatment of migraine headache In the adolescent migraine trials (12 to 17 years), the most commonly observed adverse reactions were: paresthesia, upper respiratory tract infection, anorexia, and abdominal pain The most common cognitive adverse reaction in pooled double-blind studies in adolescent patients 12 to 17 years was difficulty with concentration/attention Markedly abnormally low serum bicarbonate values indicative of metabolic acidosis were reported in topiramate-treated adolescent migraine patients In topiramate-treated patients 12 to 17 years compared to placebo-treated patients, abnormally increased results were more frequent for creatinine, BUN, uric acid, chloride, ammonia, total protein, and platelets. Abnormally decreased results were observed with topiramate vs placebo treatment for phosphorus and bicarbonate Notable changes (increases and decreases) from baseline in systolic blood pressure, diastolic blood pressure, and pulse were observed more commonly in adolescents treated with topiramate compared to adolescents treated with placebo Information on dosing, adverse reactions, laboratory abnormalities, and clinical trials Postmarketing studyLabeling-P--Janssen-FALSE'
MESH:D01711403/28/2014topamaxtopiramateProphylaxis of migraine headacheApproved for use in pediatric patients 12 years and older Safety and effectiveness in pediatric patients less than12 years have not been established for the prophylaxis treatment of migraine headache In the adolescent migraine trials (12 to 17 years), the most commonly observed adverse reactions were: paresthesia, upper respiratory tract infection, anorexia, and abdominal pain The most common cognitive adverse reaction in pooled double-blind studies in adolescent patients 12 to 17 years was difficulty with concentration/attention Markedly abnormally low serum bicarbonate values indicative of metabolic acidosis were reported in topiramate-treated adolescent migraine patients In topiramate-treated patients 12 to 17 years compared to placebo-treated patients, abnormally increased results were more frequent for creatinine, BUN, uric acid, chloride, ammonia, total protein, and platelets. Abnormally decreased results were observed with topiramate vs placebo treatment for phosphorus and bicarbonate Notable changes (increases and decreases) from baseline in systolic blood pressure, diastolic blood pressure, and pulse were observed more commonly in adolescents treated with topiramate compared to adolescents treated with placebo Information on dosing, adverse reactions, laboratory abnormalities, and clinical trials Postmarketing studyLabeling-P--Janssen-FALSE'
MESH:D0171142/11/2010ofirmevacetaminophenManagement of mild-to-moderate pain, for the management of moderate-to-severe pain with adjunctive opioid analgesics, and for the reduction of feverThe safety and effectiveness of Ofirmev for the treatment of acute pain and fever in pediatric patients ages 2 years and older is supported by evidence from adequate and well-controlled studies of Ofirmev in adults. Additional safety and PK data was collected in 355 from premature neonates to adolescents. The effectiveness of Ofirmev for the treatment of acute pain and fever has not been studied in pediatric patients < 2 years of age.The PK exposure of Ofirmev observed in children and adolescents is similar to adults, but higher in neonates and infants. Dosing simulations from PK data in infants and neonates suggest that dose reductions of 33% in infants 1 month to < 2 years of age, and 50% in neonates up to 28 days, with a minimum dosing interval of 6 hours, will produce a PK exposure similar to that observed in children age 2 years and olderMost common adverse reactions in pediatric patients were nausea, vomiting, constipation, pruritus, agitation, and atelectasis.Information on dosing, clinical studies, adverse reactions and PK parametersNew dosage form and route of administrationLabeling-P--Cadence-FALSE'
MESH:D01711401/27/2017ofirmevacetaminophenTreatmeny of pain and fever in pediatric patients birth to 2 yearsTreatment of pain Efficacy was not demonstrated in pediatric patients younger than 2 years in a double-blind, placebo-controlled study of 198 pediatric patients younger than 2 years. Pediatric patients less than 2 years of age, including neonates from 28 to 40 weeks gestational age at birth, were randomized to receive opioid plus acetaminophen or opioid plus placebo. No difference in analgesic effect of intravenous acetaminophen, measured by assessment of reduced need for additional opioid treatment for pain control, was observed. Treatment of fever The safety and effectiveness for the treatment of fever in pediatric patients, including premature neonates born at 32 weeks or greater gestation is supported by adequate and well-controlled studies of Ofirmev in adults, clinical studies in 244 pediatric patients 2 years and older, and safety and pharmacokinetic data from 239 patients younger than 2 years including neonates 32 weeks or greater gestational age. Information on dosing, clinical trials. Postmarketing study.Labeling--B,P-Mallinckrodt11/7/2016FALSE
MESH:D0171142/11/2010ofirmevacetaminophenManagement of mild-to-moderate pain, for the management of moderate-to-severe pain with adjunctive opioid analgesics, and for the reduction of feverThe safety and effectiveness of Ofirmev for the treatment of acute pain and fever in pediatric patients ages 2 years and older is supported by evidence from adequate and well-controlled studies of Ofirmev in adults. Additional safety and PK data was collected in 355 from premature neonates to adolescents. The effectiveness of Ofirmev for the treatment of acute pain and fever has not been studied in pediatric patients < 2 years of age.The PK exposure of Ofirmev observed in children and adolescents is similar to adults, but higher in neonates and infants. Dosing simulations from PK data in infants and neonates suggest that dose reductions of 33% in infants 1 month to < 2 years of age, and 50% in neonates up to 28 days, with a minimum dosing interval of 6 hours, will produce a PK exposure similar to that observed in children age 2 years and olderMost common adverse reactions in pediatric patients were nausea, vomiting, constipation, pruritus, agitation, and atelectasis.Information on dosing, clinical studies, adverse reactions and PK parametersNew dosage form and route of administrationLabeling-P--Cadence-FALSE'
MESH:D01711401/27/2017ofirmevacetaminophenTreatmeny of pain and fever in pediatric patients birth to 2 yearsTreatment of pain Efficacy was not demonstrated in pediatric patients younger than 2 years in a double-blind, placebo-controlled study of 198 pediatric patients younger than 2 years. Pediatric patients less than 2 years of age, including neonates from 28 to 40 weeks gestational age at birth, were randomized to receive opioid plus acetaminophen or opioid plus placebo. No difference in analgesic effect of intravenous acetaminophen, measured by assessment of reduced need for additional opioid treatment for pain control, was observed. Treatment of fever The safety and effectiveness for the treatment of fever in pediatric patients, including premature neonates born at 32 weeks or greater gestation is supported by adequate and well-controlled studies of Ofirmev in adults, clinical studies in 244 pediatric patients 2 years and older, and safety and pharmacokinetic data from 239 patients younger than 2 years including neonates 32 weeks or greater gestational age. Information on dosing, clinical trials. Postmarketing study.Labeling--B,P-Mallinckrodt11/7/2016FALSE
MESH:D01711403/20/2014baracludeentecavirTreatment of chronic hepatitis B virus (HBV) infectionApproved for use in pediatric patients 2 years and older Safety and effectiveness have not been established in pediatric patients less than 2 years. Use in this age group has not been evaluated because treatment of HBV in this age group is rarely required There are limited data available on the use of Baraclude in lamivudine-experienced pediatric patients Adverse reactions in clinical trials were similar to those observed in adults Information on dosing in pediatric patients 2 years and weighing at least 10 kg, adverse reactions, PK parameters and clinical trials New dosage formLabeling--B,P-Bristol-Myers Squibb-FALSE'
MESH:D01711403/20/2014baracludeentecavirTreatment of chronic hepatitis B virus (HBV) infectionApproved for use in pediatric patients 2 years and older Safety and effectiveness have not been established in pediatric patients less than 2 years. Use in this age group has not been evaluated because treatment of HBV in this age group is rarely required There are limited data available on the use of Baraclude in lamivudine-experienced pediatric patients Adverse reactions in clinical trials were similar to those observed in adults Information on dosing in pediatric patients 2 years and weighing at least 10 kg, adverse reactions, PK parameters and clinical trials New dosage formLabeling--B,P-Bristol-Myers Squibb-FALSE'