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PedAM

Pediatric Disease Annotations & Medicines



   liver neoplasms
  

Disease ID 721
Disease liver neoplasms
Definition
Tumors or cancer of the LIVER.
Synonym
hepatic neopl
hepatic neoplasia
hepatic neoplasias
hepatic neoplasm
hepatic neoplasms
hepatic tumor
hepatic tumors
hepatic tumour
hepatic tumours
hepatics tumors
hepatoma
liver neopl
liver neoplasm
liver neoplasms [disease/finding]
liver tumor
liver tumors
liver tumour
liver tumours
liver--tumors
neopl hepatic
neopl liver
neoplasm liver
neoplasm of liver
neoplasm of liver (disorder)
neoplasm of the liver
neoplasm, hepatic
neoplasm, liver
neoplasms, hepatic
neoplasms, liver
tumor liver
tumor of liver
tumour liver
tumour of liver
OMIM
DOID
UMLS
C0023903
MeSH
SNOMED-CT
Comorbidity
UMLS | Disease | Sentences' Count(Total Sentences:74)
C0019158  |  hepatitis  |  16
C0019204  |  hepatocellular carcinoma  |  10
C0019163  |  hepatitis b  |  6
C0023890  |  cirrhosis  |  6
C0019196  |  hepatitis c  |  6
C0023890  |  liver cirrhosis  |  6
C0011847  |  diabetes  |  4
C0155773  |  portal vein thrombosis  |  3
C0042769  |  virus infection  |  3
C0040053  |  thrombosis  |  3
C0206624  |  hepatoblastoma  |  3
C0206698  |  cholangiocarcinoma  |  3
C0206669  |  hepatocellular adenoma  |  2
C0041296  |  tuberculosis  |  2
C1261473  |  sarcoma  |  2
C0023895  |  liver disease  |  2
C0001430  |  adenoma  |  2
C0028754  |  obesity  |  2
C0023903  |  hepatic tumor  |  2
C0018916  |  hemangioma  |  2
C0023903  |  liver cancer  |  2
C0149925  |  small cell carcinoma  |  2
C0008311  |  cholangitis  |  2
C0024623  |  gastric cancer  |  2
C0043119  |  adult progeria  |  1
C0001418  |  adenocarcinoma  |  1
C0007137  |  epidermoid carcinoma  |  1
C0019204  |  liver carcinoma  |  1
C0013502  |  hydatid cysts  |  1
C0024299  |  lymphoma  |  1
C0494165  |  liver metastases  |  1
C0013502  |  hydatid cyst  |  1
C0345907  |  hepatic angiosarcoma  |  1
C0004623  |  bacterial infection  |  1
C0153676  |  lung metastasis  |  1
C0020437  |  hypercalcemia  |  1
C0879615  |  stromal tumor  |  1
C0279661  |  pancreatic acinar cell carcinoma  |  1
C0009402  |  colorectal cancer  |  1
C0494165  |  hepatic metastases  |  1
C0019163  |  hepatitis b infection  |  1
C0041313  |  hepatic tuberculosis  |  1
C0751498  |  sigmoid cancer  |  1
C0019204  |  hepatoma  |  1
C0010481  |  cushing syndrome  |  1
C0030305  |  pancreatitis  |  1
C0238198  |  gastrointestinal stromal tumor  |  1
C0442874  |  neuropathy  |  1
C0030499  |  parasitic disease  |  1
C0086692  |  benign neoplasm  |  1
C0010481  |  cushing's syndrome  |  1
C0007113  |  rectal cancer  |  1
C0021843  |  intestinal obstruction  |  1
C0005411  |  biliary atresia  |  1
C0878544  |  cardiomyopathy  |  1
C0019284  |  diaphragmatic hernia  |  1
C0021843  |  intestinal obstructions  |  1
C0034013  |  precocious puberty  |  1
C0043119  |  werner syndrome  |  1
C0241910  |  autoimmune hepatitis  |  1
C0023903  |  liver tumor  |  1
C0002766  |  analgesia  |  1
C0242379  |  lung cancer  |  1
C0020456  |  hyperglycemia  |  1
C0040053  |  thrombus  |  1
C0008350  |  cholelithiasis  |  1
C0031117  |  peripheral neuropathy  |  1
C0007102  |  colon cancer  |  1
C0030499  |  parasitic diseases  |  1
C0149521  |  chronic pancreatitis  |  1
C0006625  |  cachectic  |  1
C0018920  |  cavernous hemangioma  |  1
C0020538  |  hypertension  |  1
C0023891  |  alcoholic liver cirrhosis  |  1
Curated Gene
Entrez_id | Symbol | Resource(Total Genes:111)
TNF  |  7124  |  CTD_human
RAF1  |  5894  |  CTD_human
PDRG1  |  81572  |  CTD_human
TP53  |  7157  |  CTD_human
SIX3  |  6496  |  CTD_human
STAT3  |  6774  |  CTD_human
PTPRO  |  5800  |  CTD_human
HCFC1  |  3054  |  CTD_human
MYC  |  4609  |  CTD_human
IFT88  |  8100  |  CTD_human
HMOX1  |  3162  |  CTD_human
PPARA  |  5465  |  CTD_human
JUN  |  3725  |  CTD_human
IGF2  |  3481  |  CTD_human
GPX3  |  2878  |  CTD_human
CSF2  |  1437  |  CTD_human
HRAS  |  3265  |  CTD_human
TRIO  |  7204  |  CTD_human
TNFSF10  |  8743  |  CTD_human
ESR1  |  2099  |  CTD_human
NDRG1  |  10397  |  CTD_human
IL12B  |  3593  |  CTD_human
NFE2L2  |  4780  |  CTD_human
NR1H4  |  9971  |  CTD_human
PRICKLE2  |  166336  |  CTD_human
MYO5B  |  4645  |  CTD_human
LTF  |  4057  |  CTD_human
NUDT7  |  283927  |  CTD_human
ATP7B  |  540  |  CTD_human
ABL1  |  25  |  CTD_human
APCS  |  325  |  CTD_human
BRAF  |  673  |  CTD_human
CSF3  |  1440  |  CTD_human
CLSTN2  |  64084  |  CTD_human
TCF4  |  6925  |  CTD_human
ANXA2  |  302  |  CTD_human
CYP2E1  |  1571  |  CTD_human
HGF  |  3082  |  CTD_human
CDKN2A  |  1029  |  CTD_human
GNMT  |  27232  |  CTD_human
RTP3  |  83597  |  CTD_human
FST  |  10468  |  CTD_human
ITIH1  |  3697  |  CTD_human
CTNNB1  |  1499  |  CTD_human
PPARG  |  5468  |  CTD_human
KRAS  |  3845  |  CTD_human
CRABP1  |  1381  |  CTD_human
NR1I3  |  9970  |  CTD_human
PTER  |  9317  |  CTD_human
SLC11A2  |  4891  |  CTD_human
PQLC3  |  130814  |  CTD_human
FLCN  |  201163  |  CTD_human
IL2  |  3558  |  CTD_human
NOP16  |  51491  |  CTD_human
SERPINE1  |  5054  |  CTD_human
CDKN1B  |  1027  |  CTD_human
DACT2  |  168002  |  CTD_human
CCR4  |  1233  |  CTD_human
WDR17  |  116966  |  CTD_human
KRT8  |  3856  |  CTD_human
GSTM1  |  2944  |  CTD_human
TGFA  |  7039  |  CTD_human
FHIT  |  2272  |  CTD_human
ATF3  |  467  |  CTD_human
NAT2  |  10  |  CTD_human
GJB1  |  2705  |  CTD_human
AHR  |  196  |  CTD_human
PRKCE  |  5581  |  CTD_human
SLC40A1  |  30061  |  CTD_human
ACOT1  |  641371  |  CTD_human
SNHG11  |  128439  |  CTD_human
ZDHHC2  |  51201  |  CTD_human
SCD  |  6319  |  CTD_human
EXOSC2  |  23404  |  CTD_human
UGDH  |  7358  |  CTD_human
DDX54  |  79039  |  CTD_human
ANXA4  |  307  |  CTD_human
HEBP2  |  23593  |  CTD_human
ANXA7  |  310  |  CTD_human
IFNA1  |  3439  |  CTD_human
ADAMTS17  |  170691  |  CTD_human
TTC39A  |  22996  |  CTD_human
CIDEA  |  1149  |  CTD_human
CCDC134  |  79879  |  CTD_human
DPP10  |  57628  |  CTD_human
TTLL9  |  164395  |  CTD_human
YIF1A  |  10897  |  CTD_human
PLS1  |  5357  |  CTD_human
IL12A  |  3592  |  CTD_human
MAPK14  |  1432  |  CTD_human
HERC3  |  8916  |  CTD_human
SPATA21  |  374955  |  CTD_human
CPT1B  |  1375  |  CTD_human
TNK2  |  10188  |  CTD_human
PSMA4  |  5685  |  CTD_human
GADL1  |  339896  |  CTD_human
BTBD11  |  121551  |  CTD_human
SRMS  |  6725  |  CTD_human
SLC38A9  |  153129  |  CTD_human
TMEM132D  |  121256  |  CTD_human
HSDL2  |  84263  |  CTD_human
ZSCAN22  |  342945  |  CTD_human
LINGO2  |  158038  |  CTD_human
WSCD1  |  23302  |  CTD_human
DCD  |  117159  |  CTD_human
KRT18  |  3875  |  CTD_human
CHN2  |  1124  |  CTD_human
MIR29A  |  407021  |  CTD_human
HIGD2A  |  192286  |  CTD_human
NUDCD3  |  23386  |  CTD_human
EFNB2  |  1948  |  CTD_human
Inferring Gene(Waiting for update.)
Text Mined Gene
Entrez_id | Symbol | Score | Resource(Total Genes:50)
54474  |  KRT20  |  DISEASES
3956  |  LGALS1  |  DISEASES
7249  |  TSC2  |  DISEASES
1048  |  CEACAM5  |  DISEASES
51185  |  CRBN  |  DISEASES
2678  |  GGT1  |  DISEASES
968  |  CD68  |  DISEASES
2538  |  G6PC  |  DISEASES
3337  |  DNAJB1  |  DISEASES
271  |  AMPD2  |  DISEASES
2184  |  FAH  |  DISEASES
4072  |  EPCAM  |  DISEASES
1119  |  CHKA  |  DISEASES
7078  |  TIMP3  |  DISEASES
1513  |  CTSK  |  DISEASES
10  |  NAT2  |  DISEASES
4838  |  NODAL  |  DISEASES
3815  |  KIT  |  DISEASES
4286  |  MITF  |  DISEASES
1581  |  CYP7A1  |  DISEASES
51181  |  DCXR  |  DISEASES
6504  |  SLAMF1  |  DISEASES
9435  |  CHST2  |  DISEASES
6868  |  ADAM17  |  DISEASES
947  |  CD34  |  DISEASES
5591  |  PRKDC  |  DISEASES
7030  |  TFE3  |  DISEASES
5324  |  PLAG1  |  DISEASES
3855  |  KRT7  |  DISEASES
64782  |  AEN  |  DISEASES
7127  |  TNFAIP2  |  DISEASES
23583  |  SMUG1  |  DISEASES
10164  |  CHST4  |  DISEASES
1499  |  CTNNB1  |  DISEASES
55107  |  ANO1  |  DISEASES
11186  |  RASSF1  |  DISEASES
2547  |  XRCC6  |  DISEASES
4151  |  MB  |  DISEASES
4311  |  MME  |  DISEASES
3880  |  KRT19  |  DISEASES
1380  |  CR2  |  DISEASES
116496  |  FAM129A  |  DISEASES
1041  |  CDSN  |  DISEASES
2315  |  MLANA  |  DISEASES
2719  |  GPC3  |  DISEASES
983  |  CDK1  |  DISEASES
174  |  AFP  |  DISEASES
272  |  AMPD3  |  DISEASES
728441  |  GGT2  |  DISEASES
270  |  AMPD1  |  DISEASES
Locus(Waiting for update.)
Disease ID 721
Disease liver neoplasms
Integrated Phenotype(Waiting for update.)
Text Mined Phenotype
HPO | Name | Sentences' Count(Total Phenotypes:52)
HP:0002664  |  Neoplasia  |  48
HP:0012115  |  Liver inflammation  |  16
HP:0030731  |  Carcinoma  |  14
HP:0001402  |  Hepatocellular carcinoma  |  10
HP:0001394  |  Hepatic cirrhosis  |  6
HP:0200123  |  Chronic liver inflammation  |  4
HP:0001399  |  Liver failure  |  4
HP:0030242  |  Blood clot in portal vein  |  3
HP:0030153  |  Cholangiocarcinoma  |  3
HP:0002896  |  Liver cancer  |  3
HP:0002884  |  Hepatoblastoma  |  3
HP:0100523  |  Hepatic abscess  |  2
HP:0012378  |  Fatigue  |  2
HP:0012126  |  Gastric cancer  |  2
HP:0002202  |  Pleural effusion  |  2
HP:0100242  |  Sarcoma  |  2
HP:0030151  |  Cholangitis  |  2
HP:0001028  |  Strawberry mark  |  2
HP:0012028  |  Hepatocellular adenoma  |  2
HP:0001513  |  Obesity  |  2
HP:0002240  |  Enlarged liver  |  2
HP:0002835  |  Aspiration  |  2
HP:0001410  |  Decreased liver function  |  2
HP:0005214  |  Bowel obstruction  |  1
HP:0003072  |  Hypercalcemia  |  1
HP:0001048  |  Cavernous angioma  |  1
HP:0000969  |  Dropsy  |  1
HP:0006280  |  Chronic pancreas inflammation  |  1
HP:0002665  |  Lymphoma  |  1
HP:0100723  |  Gastrointestinal stroma tumor  |  1
HP:0100762  |  Hemobilia  |  1
HP:0001397  |  Hepatic steatosis  |  1
HP:0003003  |  Colon cancer  |  1
HP:0003287  |  Abnormality of mitochondrial metabolism  |  1
HP:0001638  |  Cardiomyopathy  |  1
HP:0008236  |  Isosexual precocious puberty  |  1
HP:0000826  |  Precocious puberty  |  1
HP:0001541  |  Ascites  |  1
HP:0002094  |  Dyspnea  |  1
HP:0000776  |  Diaphragmatic hernia  |  1
HP:0003073  |  Hypoalbuminaemia  |  1
HP:0001081  |  Gallstones  |  1
HP:0009830  |  Peripheral neuritis  |  1
HP:0009726  |  Renal neoplasm  |  1
HP:0000822  |  Hypertension  |  1
HP:0001733  |  Pancreatic inflammation  |  1
HP:0200058  |  Angiosarcoma  |  1
HP:0004787  |  Fulminant hepatitis  |  1
HP:0001578  |  Hypercortisolism  |  1
HP:0100820  |  Glomerulopathy  |  1
HP:0005912  |  Biliary duct atresia  |  1
HP:0003074  |  High blood glucose  |  1
Disease ID 721
Disease liver neoplasms
Manually Symptom(Waiting for update.)
Text Mined Symptom
UMLS | Name | Sentences' Count(Total Symptoms:7)
C0009450  |  infection  |  6
C0019204  |  hepatocellular carcinoma  |  5
C0426768  |  o sign  |  4
C0020437  |  hypercalcemia  |  1
C0153676  |  lung metastasis  |  1
C0002793  |  dedifferentiation  |  1
C0019158  |  hepatitis  |  1
Manually Genotype(Total Text Mining Genotypes:0)
(Waiting for update.)
All Snps(Total Genotypes:11)
snpId pubmedId geneId geneSymbol diseaseId sourceId sentence score Year geneSymbol_dbSNP CHROMOSOME POS REF ALT
rs11348802225549141673BRAFumls:C0023903BeFreeTo summarize the usefulness of several recently discovered immunohistochemical markers in the study of gastrointestinal and liver tumors; to suggest the most current and effective immunohistochemical panels addressing common diagnostic challenges for these tumors; to share practical experience and useful tips for human epidermal growth factor receptor 2 testing in gastric and gastroesophageal junction adenocarcinoma and v-raf murine sarcoma viral oncogene homolog B V600E immunohistochemistry in colorectal carcinoma.0.1229099162015BRAF7140753336AT,G,C
rs113488022255491412064ERBB2umls:C0023903BeFreeTo summarize the usefulness of several recently discovered immunohistochemical markers in the study of gastrointestinal and liver tumors; to suggest the most current and effective immunohistochemical panels addressing common diagnostic challenges for these tumors; to share practical experience and useful tips for human epidermal growth factor receptor 2 testing in gastric and gastroesophageal junction adenocarcinoma and v-raf murine sarcoma viral oncogene homolog B V600E immunohistochemistry in colorectal carcinoma.0.0010857672015BRAF7140753336AT,G,C
rs13181199196862068ERCC2umls:C0023903GAD[XPD codon 751 polymorphism modifies the risk of hepatocellular carcinoma]0.0026384742009ERCC2;KLC31945351661TA,G
rs199475623174086074153MBL2umls:C0023903BeFreeExpression analysis of the D129G mutation was performed in E. coli (expression as fusion protein MBP-PAH) and in a human hepatoma cell line with an N-terminal FLAG epitope.0.0010857672007PAH12102877517TC,A
rs199475623174086075053PAHumls:C0023903BeFreeExpression analysis of the D129G mutation was performed in E. coli (expression as fusion protein MBP-PAH) and in a human hepatoma cell line with an N-terminal FLAG epitope.0.0019000932007PAH12102877517TC,A
rs199475623174086074155MBPumls:C0023903BeFreeExpression analysis of the D129G mutation was performed in E. coli (expression as fusion protein MBP-PAH) and in a human hepatoma cell line with an N-terminal FLAG epitope.0.0008143262007PAH12102877517TC,A
rs199475623174086075553PRG2umls:C0023903BeFreeExpression analysis of the D129G mutation was performed in E. coli (expression as fusion protein MBP-PAH) and in a human hepatoma cell line with an N-terminal FLAG epitope.0.0008143262007PAH12102877517TC,A
rs361525209535247124TNFumls:C0023903GAD[This meta-analysis supports TNF rs361525 (-238G>A) polymorphism being associated with HCC in an Asian population.]0.1581762912010TNF631575324GA
rs3811647235884707018TFumls:C0023903BeFreeIntronic SNP rs3811647 of the human transferrin gene modulates its expression in hepatoma cells.0.0005428842012TF3133765185GA
rs430397195336863309HSPA5umls:C0023903GAD[allele A and genotypes AA and AG of rs430397 may represent high risk and poor prognosis for HCC.]0.0031813582009HSPA59125238840CT
rs62508577196296565053PAHumls:C0023903BeFreeWe analyzed p.S231F PAH protein in prokaryotic (Escherichia coli) and eukaryotic expression system (hepatoma cells).0.0019000932009PAH12102855150GA
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:48)
CUI ChemicalName ChemicalID CasRN DiseaseName DiseaseID DirectEvidence PubMedIDs
C0023903acetaminophenD000082103-90-2liver neoplasmsMESH:D008113marker/mechanism22084566
C0023903s-adenosylmethionineD01243629908-03-0liver neoplasmsMESH:D008113therapeutic12163149
C0023903arsenic trioxideC0066321327-53-3liver neoplasmsMESH:D008113marker/mechanism14682389
C0023903betaineD001622107-43-7liver neoplasmsMESH:D008113therapeutic19642983
C0023903caffeineD0021101958/8/2liver neoplasmsMESH:D008113therapeutic1995187
C0023903capsaicinD002211404-86-4liver neoplasmsMESH:D008113therapeutic1888447
C0023903carbamazepineD002220298-46-4liver neoplasmsMESH:D008113marker/mechanism25058030
C0023903cerivastatinC086276-liver neoplasmsMESH:D008113marker/mechanism25058030
C0023903chlorambucilD002699305-03-3liver neoplasmsMESH:D008113therapeutic3465877
C0023903cholineD00279462-49-7liver neoplasmsMESH:D008113marker/mechanism3554467
C0023903cyclophosphamideD00352050-18-0liver neoplasmsMESH:D008113therapeutic18298334
C0023903cisplatinD00294515663-27-1liver neoplasmsMESH:D008113therapeutic2933968
C0023903diethylstilbestrolD00405456-53-1liver neoplasmsMESH:D008113marker/mechanism15890375
C0023903epirubicinD01525156420-45-2liver neoplasmsMESH:D008113therapeutic3465877
C0023903floxuridineD00546750-91-9liver neoplasmsMESH:D008113therapeutic11677951
C0023903fluconazoleD01572586386-73-4liver neoplasmsMESH:D008113marker/mechanism25058030
C0023903fluorouracilD00547251-21-8liver neoplasmsMESH:D008113therapeutic15113037
C0023903leucovorinD0029551958/5/9liver neoplasmsMESH:D008113therapeutic21208846
C0023903gemcitabineC056507103882-84-4liver neoplasmsMESH:D008113therapeutic10965557
C0023903glutathioneD00597870-18-8liver neoplasmsMESH:D008113therapeutic7852184
C0023903griseofulvinD006118126-07-8liver neoplasmsMESH:D008113marker/mechanism2445643
C0023903indomethacinD00721353-86-1liver neoplasmsMESH:D008113marker/mechanism1477515
C0023903lindaneD00155658-89-9liver neoplasmsMESH:D008113marker/mechanism18951770
C0023903lovastatinD00814875330-75-5liver neoplasmsMESH:D008113marker/mechanism25058030
C0023903melphalanD008558148-82-3liver neoplasmsMESH:D008113therapeutic12606622
C0023903methotrexateD0087271959/5/2liver neoplasmsMESH:D008113therapeutic3465877
C0023903methylphenidateD008774113-45-1liver neoplasmsMESH:D008113marker/mechanism8545847
C0023903mitomycinD0166851950/7/7liver neoplasmsMESH:D008113therapeutic15113037
C0023903norepinephrineD00963851-41-2liver neoplasmsMESH:D008113therapeutic1530348
C0023903oxaliplatinC030110-liver neoplasmsMESH:D008113therapeutic21208846
C0023903paclitaxelD017239-liver neoplasmsMESH:D008113therapeutic11468447
C0023903pantoprazoleC064276102625-70-7liver neoplasmsMESH:D008113marker/mechanism25058030
C0023903phenytoinD01067257-41-0liver neoplasmsMESH:D008113marker/mechanism25058030
C0023903pregabalinD000069583-liver neoplasmsMESH:D008113marker/mechanism22539615
C0023903propranololD011433525-66-6liver neoplasmsMESH:D008113therapeutic19743301
C0023903sorafenibC471405-liver neoplasmsMESH:D008113therapeutic25489883
C0023903spironolactoneD0131481952/1/7liver neoplasmsMESH:D008113marker/mechanism25058030
C0023903streptozocinD01331118883-66-4liver neoplasmsMESH:D008113marker/mechanism2532796
C0023903streptozocinD01331118883-66-4liver neoplasmsMESH:D008113therapeutic227055
C0023903toremifeneD01731289778-26-7liver neoplasmsMESH:D008113marker/mechanism7586193
C0023903toremifeneD01731289778-26-7liver neoplasmsMESH:D008113therapeutic8402624
C0023903triamtereneD014223396-01-0liver neoplasmsMESH:D008113marker/mechanism25058030
C0023903troglitazoneC05769397322-87-7liver neoplasmsMESH:D008113therapeutic10503899
C0023903vinblastineD014747865-21-4liver neoplasmsMESH:D008113therapeutic3686684
C0023903vinorelbineC03085271486-22-1liver neoplasmsMESH:D008113therapeutic9849468
C0023903vitamin aD01480111103-57-4liver neoplasmsMESH:D008113marker/mechanism2055368
C0023903vorinostatC111237-liver neoplasmsMESH:D008113therapeutic17593366
C0023903zidovudineD01521530516-87-1liver neoplasmsMESH:D008113marker/mechanism10558926
FDA approved drug and dosage information(Total Drugs:20)
DiseaseID Drug_name active_ingredients strength Dosage Form/Route Marketing Status TE code RLD RS
MESH:D008113mevacorlovastatin10MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasonsTABLET;ORALDiscontinuedNoneYesNo
MESH:D008113daytranamethylphenidate10MG/9HR (1.1MG/HR)FILM, EXTENDED RELEASE;TRANSDERMALPrescriptionNoneYesNo
MESH:D008113daytranamethylphenidate10MG/9HR (1.1MG/HR)FILM, EXTENDED RELEASE;TRANSDERMALPrescriptionNoneYesNo
MESH:D008113daytranamethylphenidate10MG/9HR (1.1MG/HR)FILM, EXTENDED RELEASE;TRANSDERMALPrescriptionNoneYesNo
MESH:D008113eloxatinoxaliplatin50MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasonsINJECTABLE;IV (INFUSION)DiscontinuedNoneYesNo
MESH:D008113eloxatinoxaliplatin50MG/10ML (5MG/ML)INJECTABLE;IV (INFUSION)PrescriptionAPYesYes
MESH:D008113oxaliplatinoxaliplatin50MG/10ML (5MG/ML)INJECTABLE;IV (INFUSION)PrescriptionAPYesYes
MESH:D008113retrovirzidovudine100MGCAPSULE;ORALPrescriptionABYesYes
MESH:D008113retrovirzidovudine50MG/5MLSYRUP;ORALPrescriptionAAYesYes
MESH:D008113retrovirzidovudine10MG/MLINJECTABLE;INJECTIONPrescriptionAPYesYes
MESH:D008113retrovirzidovudine200MGTABLET;ORALDiscontinuedNoneNoNo
MESH:D008113zidovudinezidovudine60MGTABLET;ORALDiscontinuedNoneNoNo
MESH:D008113zidovudinezidovudine60MGTABLET;ORALDiscontinuedNoneNoNo
MESH:D008113ofirmevacetaminophen1GM/100ML (10MG/ML)SOLUTION;IV (INFUSION)PrescriptionAPYesYes
MESH:D008113ofirmevacetaminophen1GM/100ML (10MG/ML)SOLUTION;IV (INFUSION)PrescriptionAPYesYes
MESH:D008113acetaminophenacetaminophen650MGSUPPOSITORY;RECTALOver-the-counterNoneYesYes
MESH:D008113acetaminophenacetaminophen650MGSUPPOSITORY;RECTALOver-the-counterNoneYesYes
MESH:D008113lyricapregabalin25MGCAPSULE;ORALPrescriptionNoneYesNo
MESH:D008113lyricapregabalin25MGCAPSULE; ORALPrescriptionNoneNoNo
MESH:D008113lyricapregabalin25MGCAPSULE; ORALPrescriptionNoneNoNo
FDA labeling changes(Total Drugs:20)
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:D00811302/14/2002mevacorlovastatinHeterozygous Familial HypercholesterolemiaNew indication in adolescent boys and girls (at least one year post-menarche) 10-17 years of ageLabelingB---Merck07/17/2001FALSE'
MESH:D0081136/4/2006daytranamethylphenidateADHDSummary is pendingLabeling-P--Shire-FALSE'
MESH:D00811312/14/2009daytranamethylphenidatePostmarketing safety studyInformation added to Warnings and Adverse Reactions on skin reactions observed in a postmarketing dermal study in pediatric patientsLabeling-P--Shire-FALSE'
MESH:D00811306/29/2010daytranamethylphenidateADHDExpanded pediatric indication to include adolescent patients ages13-17 years The most commonly reported adverse reactions in a trial in patients 13-17 years included appetite decreased, nausea, insomnia, weight decreased, dizziness, abdominal pain, and anorexia. The majority of patients had erythema at the application site Information on PK parameters, Adverse Event profile and clinical studiesLabeling-P--Shire-FALSE'
MESH:D00811310/1/2007eloxatinoxaliplatinSolid tumorsThe effectiveness of oxaliplatin in children has not been established No significant activity observed in 2 Phase I and 2 Phase II trials in 159 patients ages 7 months to 22 years with solid tumors Information on clinical studies and AEsLabelingB---Sanofi-Aventis09/27/2006FALSE'
MESH:D00811310/1/2007eloxatinoxaliplatinSolid tumorsThe effectiveness of oxaliplatin in children has not been established No significant activity observed in 2 Phase I and 2 Phase II trials in 159 patients ages 7 months to 22 years with solid tumors Information on clinical studies and AEsLabelingB---Sanofi-Aventis09/27/2006FALSE'
MESH:D00811310/1/2007eloxatinoxaliplatinSolid tumorsThe effectiveness of oxaliplatin in children has not been established No significant activity observed in 2 Phase I and 2 Phase II trials in 159 patients ages 7 months to 22 years with solid tumors Information on clinical studies and AEsLabelingB---Sanofi-Aventis09/27/2006FALSE'
MESH:D0081136/11/2009retrovirzidovudineTreatment of HIV-1 infection in combination with other antiretroviral agentsProvided dosing recommendations for patients 4 weeks to < 6 weeks of age and weighing 4 kg to < 9 kgLabeling-P--GlaxoSmithKline-TRUE'
MESH:D0081136/11/2009retrovirzidovudineTreatment of HIV-1 infection in combination with other antiretroviral agentsProvided dosing recommendations for patients 4 weeks to < 6 weeks of age and weighing 4 kg to < 9 kgLabeling-P--GlaxoSmithKline-TRUE'
MESH:D0081136/11/2009retrovirzidovudineTreatment of HIV-1 infection in combination with other antiretroviral agentsProvided dosing recommendations for patients 4 weeks to < 6 weeks of age and weighing 4 kg to < 9 kgLabeling-P--GlaxoSmithKline-TRUE'
MESH:D0081136/11/2009retrovirzidovudineTreatment of HIV-1 infection in combination with other antiretroviral agentsProvided dosing recommendations for patients 4 weeks to < 6 weeks of age and weighing 4 kg to < 9 kgLabeling-P--GlaxoSmithKline-TRUE'
MESH:D00811309/19/2008retrovir syrup, capsules and tabletszidovudineUsed in combination with 18 other antiretroviral agents for the treatment of HIV-1 infectionDosing and administration information provided to children 6 weeks to less than 18 years of age Macrocytosis was reported in the majority of pediatric patients receiving Retrovir 180 mg/m2 every 6 hours in open-label studies New dosing regimenLabeling-P--GlaxoSmithKline-TRUE'
MESH:D0081136/11/2009retrovirzidovudineTreatment of HIV-1 infection in combination with other antiretroviral agentsProvided dosing recommendations for patients 4 weeks to < 6 weeks of age and weighing 4 kg to < 9 kgLabeling-P--GlaxoSmithKline-TRUE'
MESH:D0081132/11/2010ofirmevacetaminophenManagement 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:D00811301/27/2017ofirmevacetaminophenTreatmeny 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:D0081132/11/2010ofirmevacetaminophenManagement 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:D00811301/27/2017ofirmevacetaminophenTreatmeny 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:D00811312/22/2016lyricapregabalinFibromyalgiaSafety and efficacy in pediatric patients have not been established. A 15-week, placebo-controlled trial was conducted with 107 pediatric patients with fibromyalgia, ages 12 through 17 years . The primary efficacy endpoint of change from baseline to Week 15 in mean pain intensity showed numerically greater improvement for the pregabalin-treated patients compared to placebo-treated patients, but did not reach statistical significance. The most frequently observed adverse reactions in the clinical trial included dizziness, nausea, headache, weight increased, and fatigue. The overall safety profile in adolescents was similar to that observed in adults with fibromyalgia. Postmarketing study.Labeling-P--PF Prism CV-FALSE
MESH:D00811312/22/2016lyricapregabalinFibromyalgiaSafety and efficacy in pediatric patients have not been established. A 15-week, placebo-controlled trial was conducted with 107 pediatric patients with fibromyalgia, ages 12 through 17 years . The primary efficacy endpoint of change from baseline to Week 15 in mean pain intensity showed numerically greater improvement for the pregabalin-treated patients compared to placebo-treated patients, but did not reach statistical significance. The most frequently observed adverse reactions in the clinical trial included dizziness, nausea, headache, weight increased, and fatigue. The overall safety profile in adolescents was similar to that observed in adults with fibromyalgia. Postmarketing study.Labeling-P--PF Prism CV-FALSE
MESH:D00811312/22/2016lyricapregabalinFibromyalgiaSafety and efficacy in pediatric patients have not been established. A 15-week, placebo-controlled trial was conducted with 107 pediatric patients with fibromyalgia, ages 12 through 17 years . The primary efficacy endpoint of change from baseline to Week 15 in mean pain intensity showed numerically greater improvement for the pregabalin-treated patients compared to placebo-treated patients, but did not reach statistical significance. The most frequently observed adverse reactions in the clinical trial included dizziness, nausea, headache, weight increased, and fatigue. The overall safety profile in adolescents was similar to that observed in adults with fibromyalgia. Postmarketing study.Labeling-P--PF Prism CV-FALSE