PedAM

Pediatric Disease Annotations & Medicines


	cholestasis

Disease ID	524
Disease	cholestasis
Definition	Impairment of bile flow due to obstruction in small bile ducts (INTRAHEPATIC CHOLESTASIS) or obstruction in large bile ducts (EXTRAHEPATIC CHOLESTASIS).
Synonym	bile duct obstruction bile duct obstructions bile duct occlusion bile ducts obstruction bile ducts obstructions bile obstruction bile occlusion bile stasis bile stasis, nos biles ducts obstruction biles ducts obstructions biliary stases biliary stasis cholestases cholestasis (finding) cholestasis [disease/finding] cholestasis, nos duct obstruction, bile duct obstructions, bile obstruction bile duct obstruction of bile duct obstruction of bile duct (disorder) obstruction of bile duct nos obstruction of bile duct nos (disorder) obstruction of bile duct, nos obstruction, bile duct obstructions, bile duct occlusion of bile duct occlusion of bile duct (disorder) occlusion of bile duct, nos of bile duct obstruction stases, biliary stasis, biliary
DOID	DOID:13580
ICD10	ICD10CM:K83.1
UMLS	C0008370
MeSH	D002779
SNOMED-CT	SNOMEDCT_US_2016_09_01:30144000;SNOMEDCT_US_2016_09_01:197446008;SNOMEDCT_US_2016_09_01:33688009
Comorbidity	UMLS \| Disease \| Sentences' Count(Total Sentences:83) C0019158 \| hepatitis \| 26 C0023890 \| cirrhosis \| 13 C0023895 \| liver disease \| 7 C0008312 \| biliary cirrhosis \| 6 C0019343 \| pemphigoid gestationis \| 5 C0024523 \| malabsorption \| 3 C0020443 \| hypercholesterolemia \| 3 C0010674 \| cystic fibrosis \| 3 C0019196 \| hepatitis c \| 3 C0030805 \| pemphigoid \| 3 C0008350 \| cholelithiasis \| 2 C0042109 \| urticarial \| 2 C0008311 \| cholangitis \| 2 C0008312 \| primary biliary cirrhosis \| 2 C0023890 \| liver cirrhosis \| 2 C0036992 \| short bowel syndrome \| 2 C0023895 \| liver diseases \| 2 C0030305 \| pancreatitis \| 2 C0042721 \| viral hepatitis \| 2 C0019045 \| hemoglobinopathies \| 1 C0019114 \| hemosiderosis \| 1 C0019621 \| langerhans cell histiocytosis \| 1 C0010692 \| bladder inflammation \| 1 C0162429 \| malnutrition \| 1 C0011847 \| diabetes \| 1 C0042870 \| vitamin d deficiency \| 1 C0004030 \| aspergillosis \| 1 C0007134 \| renal cell carcinoma \| 1 C0032827 \| k deficiency \| 1 C0022658 \| renal disease \| 1 C0005411 \| biliary atresia \| 1 C0520459 \| necrotizing enterocolitis \| 1 C0002871 \| anemia \| 1 C0020305 \| hydrops fetalis \| 1 C0019621 \| histiocytosis x \| 1 C0085207 \| gestational diabetes \| 1 C0042870 \| vitamin d defic \| 1 C0267917 \| acute cholangitis \| 1 C0162568 \| erythropoietic protoporphyria \| 1 C0346185 \| ovarian dysgerminoma \| 1 C0022116 \| ischemia \| 1 C1859722 \| arc syndrome \| 1 C0019196 \| hepatitis c infection \| 1 C0162568 \| protoporphyria \| 1 C0022661 \| chronic renal disease \| 1 C0878544 \| cardiomyopathy \| 1 C0024299 \| lymphoma \| 1 C0040100 \| thymoma \| 1 C0008313 \| sclerosing cholangitis \| 1 C0206624 \| hepatoblastoma \| 1 C0030293 \| pancreatic insufficiency \| 1 C0038238 \| steatorrhea \| 1 C0035579 \| rickets \| 1 C0002895 \| sickle cell disease \| 1 C1621895 \| adrenal hyperplasia \| 1 C0022353 \| neonatal jaundice \| 1 C0008350 \| gallstone \| 1 C0008350 \| gallstones \| 1 C0004623 \| bacterial infection \| 1 C0376358 \| prostate cancer \| 1 C0019618 \| histiocytosis \| 1 C0087086 \| thrombi \| 1 C0037274 \| dermatoses \| 1 C0021053 \| immune disease \| 1 C0152096 \| trisomy 18 \| 1 C0017551 \| gilbert's syndrome \| 1 C0024236 \| lymphedema \| 1 C1956257 \| pulmonary stenosis \| 1 C0206698 \| cholangiocarcinoma \| 1 C0042769 \| virus infection \| 1 C0009207 \| cockayne syndrome \| 1 C0032285 \| pneumoniae \| 1 C1565489 \| renal insufficiency \| 1 C0023890 \| hepatic cirrhosis \| 1 C0001623 \| adrenal insufficiency \| 1 C0024530 \| malaria \| 1 C0018801 \| heart failure \| 1 C0008340 \| choledochal cyst \| 1 C0019163 \| hepatitis b \| 1 C0017205 \| gaucher disease \| 1 C0014130 \| endocrine disorders \| 1 C0020550 \| hyperthyroidism \| 1 C0023895 \| hepatocellular disease \| 1
Curated Gene	Entrez_id \| Symbol \| Resource(Total Genes:59) TNF \| 7124 \| CTD_human NQO1 \| 1728 \| CTD_human ATP8B1 \| 5205 \| UniProtKB-KW BLVRA \| 644 \| CTD_human IL6 \| 3569 \| CTD_human ICAM1 \| 3383 \| CTD_human POMC \| 5443 \| CTD_human SLC51A \| 200931 \| CTD_human SLC51B \| 123264 \| CTD_human ABCB11 \| 8647 \| CTD_human;UniProtKB-KW;GHR AMACR \| 23600 \| UniProtKB-KW VCAM1 \| 7412 \| CTD_human MIR27B \| 407019 \| CTD_human CXCL2 \| 2920 \| CTD_human RELA \| 5970 \| CTD_human FGA \| 2243 \| CTD_human NOS2 \| 4843 \| CTD_human PDYN \| 5173 \| CTD_human TJP2 \| 9414 \| UniProtKB-KW SLC25A13 \| 10165 \| UniProtKB-KW NFE2L2 \| 4780 \| CTD_human MIR185 \| 406961 \| CTD_human CYP27A1 \| 1593 \| CTD_human NR1H4 \| 9971 \| CTD_human;UniProtKB-KW NR1H2 \| 7376 \| CTD_human CYP7B1 \| 9420 \| CTD_human;UniProtKB-KW MIR337 \| 442905 \| CTD_human ABCB4 \| 5244 \| UniProtKB-KW;GHR SERPINA1 \| 5265 \| CTD_human IGF1 \| 3479 \| CTD_human HSD3B7 \| 80270 \| CTD_human;UniProtKB-KW MIRLET7I \| 406891 \| CTD_human MIRLET7B \| 406884 \| CTD_human SERPINE1 \| 5054 \| CTD_human F2RL3 \| 9002 \| CTD_human EGR1 \| 1958 \| CTD_human CYP8B1 \| 1582 \| CTD_human ABCC2 \| 1244 \| CTD_human ABCC3 \| 8714 \| CTD_human CXCL8 \| 3576 \| CTD_human CCL7 \| 6354 \| CTD_human AKR1D1 \| 6718 \| UniProtKB-KW NR1H3 \| 10062 \| CTD_human RDX \| 5962 \| CTD_human MIR99A \| 407055 \| CTD_human MIR218-1 \| 407000 \| CTD_human MAPK14 \| 1432 \| CTD_human MAPK13 \| 5603 \| CTD_human SLC23A2 \| 9962 \| CTD_human SLC23A1 \| 9963 \| CTD_human MIR377 \| 494326 \| CTD_human MIR361 \| 494323 \| CTD_human MIR190A \| 406965 \| CTD_human SNAI1 \| 6615 \| CTD_human CYP7A1 \| 1581 \| CTD_human MIR130B \| 406920 \| CTD_human MIR875 \| 100126309 \| CTD_human MIR411 \| 693121 \| CTD_human MIR24-1 \| 407012 \| CTD_human
Inferring Gene	Entrez_id \| Symbol \| Resource(Total Genes:7) 8647 \| ABCB11 \| infer 5244 \| ABCB4 \| infer 5205 \| ATP8B1 \| infer 2099 \| ESR1 \| infer 3113 \| HLA-DPA1 \| infer 6580 \| SLC22A1 \| infer 6581 \| SLC22A3 \| infer
Text Mined Gene	Entrez_id \| Symbol \| Score \| Resource(Total Genes:444) 100506492 \| DSCAM-AS1 \| DISEASES 1080 \| CFTR \| DISEASES 6344 \| SCTR \| DISEASES 5009 \| OTC \| DISEASES 608 \| TNFRSF17 \| DISEASES 84957 \| RELT \| DISEASES 23152 \| CIC \| DISEASES 634 \| CEACAM1 \| DISEASES 4335 \| MNT \| DISEASES 6343 \| SCT \| DISEASES 1071 \| CETP \| DISEASES 2099 \| ESR1 \| DISEASES 23411 \| SIRT1 \| DISEASES 4282 \| MIF \| DISEASES 6948 \| TCN2 \| DISEASES 3162 \| HMOX1 \| DISEASES 11035 \| RIPK3 \| DISEASES 1113 \| CHGA \| DISEASES 6554 \| SLC10A1 \| DISEASES 2937 \| GSS \| DISEASES 28231 \| SLCO4A1 \| DISEASES 5173 \| PDYN \| DISEASES 5020 \| OXT \| DISEASES 3421 \| IDH3G \| DISEASES 7076 \| TIMP1 \| DISEASES 4313 \| MMP2 \| DISEASES 343 \| AQP8 \| DISEASES 10423 \| CDIPT \| DISEASES 366 \| AQP9 \| DISEASES 1666 \| DECR1 \| DISEASES 8857 \| FCGBP \| DISEASES 2091 \| FBL \| DISEASES 7040 \| TGFB1 \| DISEASES 973 \| CD79A \| DISEASES 1048 \| CEACAM5 \| DISEASES 6822 \| SULT2A1 \| DISEASES 57817 \| HAMP \| DISEASES 3082 \| HGF \| DISEASES 5054 \| SERPINE1 \| DISEASES 8985 \| PLOD3 \| DISEASES 56521 \| DNAJC12 \| DISEASES 4353 \| MPO \| DISEASES 2584 \| GALK1 \| DISEASES 6347 \| CCL2 \| DISEASES 6928 \| HNF1B \| DISEASES 5539 \| PPY \| DISEASES 230 \| ALDOC \| DISEASES 51056 \| LAP3 \| DISEASES 3558 \| IL2 \| DISEASES 345 \| APOC3 \| DISEASES 3458 \| IFNG \| DISEASES 2026 \| ENO2 \| DISEASES 2729 \| GCLC \| DISEASES 55754 \| TMEM30A \| DISEASES 3565 \| IL4 \| DISEASES 11334 \| TUSC2 \| DISEASES 338 \| APOB \| DISEASES 4358 \| MPV17 \| DISEASES 335 \| APOA1 \| DISEASES 7276 \| TTR \| DISEASES 9429 \| ABCG2 \| DISEASES 1958 \| EGR1 \| DISEASES 847 \| CAT \| DISEASES 10804 \| GJB6 \| DISEASES 6718 \| AKR1D1 \| DISEASES 540 \| ATP7B \| DISEASES 583 \| BBS2 \| DISEASES 2806 \| GOT2 \| DISEASES 6555 \| SLC10A2 \| DISEASES 6662 \| SOX9 \| DISEASES 51081 \| MRPS7 \| DISEASES 7355 \| SLC35A2 \| DISEASES 92797 \| HELB \| DISEASES 2678 \| GGT1 \| DISEASES 968 \| CD68 \| DISEASES 3630 \| INS \| DISEASES 348 \| APOE \| DISEASES 1571 \| CYP2E1 \| DISEASES 445 \| ASS1 \| DISEASES 23473 \| CAPN7 \| DISEASES 9945 \| GFPT2 \| DISEASES 8431 \| NR0B2 \| DISEASES 113 \| ADCY7 \| DISEASES 6737 \| TRIM21 \| DISEASES 23225 \| NUP210 \| DISEASES 84105 \| PCBD2 \| DISEASES 182 \| JAG1 \| DISEASES 1401 \| CRP \| DISEASES 6341 \| SCO1 \| DISEASES 4922 \| NTS \| DISEASES 3845 \| KRAS \| DISEASES 10752 \| CHL1 \| DISEASES 4853 \| NOTCH2 \| DISEASES 2922 \| GRP \| DISEASES 10599 \| SLCO1B1 \| DISEASES 6927 \| HNF1A \| DISEASES 1593 \| CYP27A1 \| DISEASES 3569 \| IL6 \| DISEASES 26525 \| IL36RN \| DISEASES 55997 \| CFC1 \| DISEASES 9394 \| HS6ST1 \| DISEASES 570 \| BAAT \| DISEASES 5168 \| ENPP2 \| DISEASES 4316 \| MMP7 \| DISEASES 58472 \| SQRDL \| DISEASES 64240 \| ABCG5 \| DISEASES 6741 \| SSB \| DISEASES 9360 \| PPIG \| DISEASES 10063 \| COX17 \| DISEASES 28234 \| SLCO1B3 \| DISEASES 9786 \| KIAA0586 \| DISEASES 10162 \| LPCAT3 \| DISEASES 949 \| SCARB1 \| DISEASES 10961 \| ERP29 \| DISEASES 2184 \| FAH \| DISEASES 8766 \| RAB11A \| DISEASES 54947 \| LPCAT2 \| DISEASES 4087 \| SMAD2 \| DISEASES 2294 \| FOXF1 \| DISEASES 27443 \| CECR2 \| DISEASES 5465 \| PPARA \| DISEASES 7077 \| TIMP2 \| DISEASES 671 \| BPI \| DISEASES 25939 \| SAMHD1 \| DISEASES 27134 \| TJP3 \| DISEASES 5595 \| MAPK3 \| DISEASES 10998 \| SLC27A5 \| DISEASES 23523 \| CABIN1 \| DISEASES 6855 \| SYP \| DISEASES 3553 \| IL1B \| DISEASES 8647 \| ABCB11 \| DISEASES 3931 \| LCAT \| DISEASES 2817 \| GPC1 \| DISEASES 1716 \| DGUOK \| DISEASES 79031 \| PDCL3 \| DISEASES 590 \| BCHE \| DISEASES 1356 \| CP \| DISEASES 6774 \| STAT3 \| DISEASES 5443 \| POMC \| DISEASES 3383 \| ICAM1 \| DISEASES 10891 \| PPARGC1A \| DISEASES 2162 \| F13A1 \| DISEASES 10058 \| ABCB6 \| DISEASES 11112 \| HIBADH \| DISEASES 644 \| BLVRA \| DISEASES 5244 \| ABCB4 \| DISEASES 5243 \| ABCB1 \| DISEASES 8034 \| SLC25A16 \| DISEASES 7008 \| TEF \| DISEASES 122481 \| AK7 \| DISEASES 6652 \| SORD \| DISEASES 58488 \| PCTP \| DISEASES 4864 \| NPC1 \| DISEASES 7157 \| TP53 \| DISEASES 150094 \| SIK1 \| DISEASES 207 \| AKT1 \| DISEASES 5972 \| REN \| DISEASES 64241 \| ABCG8 \| DISEASES 133688 \| UGT3A1 \| DISEASES 167410 \| LIX1 \| DISEASES 51302 \| CYP39A1 \| DISEASES 8795 \| TNFRSF10B \| DISEASES 3439 \| IFNA1 \| DISEASES 4851 \| NOTCH1 \| DISEASES 1737 \| DLAT \| DISEASES 7082 \| TJP1 \| DISEASES 5741 \| PTH \| DISEASES 3087 \| HHEX \| DISEASES 3694 \| ITGB6 \| DISEASES 79888 \| LPCAT1 \| DISEASES 5205 \| ATP8B1 \| DISEASES 79895 \| ATP8B4 \| DISEASES 4645 \| MYO5B \| DISEASES 8714 \| ABCC3 \| DISEASES 761 \| CA3 \| DISEASES 5018 \| OXA1L \| DISEASES 27163 \| NAAA \| DISEASES 9154 \| SLC28A1 \| DISEASES 4838 \| NODAL \| DISEASES 6750 \| SST \| DISEASES 5468 \| PPARG \| DISEASES 9069 \| CLDN12 \| DISEASES 11309 \| SLCO2B1 \| DISEASES 1636 \| ACE \| DISEASES 5739 \| PTGIR \| DISEASES 23387 \| SIK3 \| DISEASES 2264 \| FGFR4 \| DISEASES 3856 \| KRT8 \| DISEASES 1990 \| CELA1 \| DISEASES 9965 \| FGF19 \| DISEASES 7412 \| VCAM1 \| DISEASES 2215 \| FCGR3B \| DISEASES 27306 \| HPGDS \| DISEASES 248 \| ALPI \| DISEASES 213 \| ALB \| DISEASES 8820 \| HESX1 \| DISEASES 7349 \| UCN \| DISEASES 200931 \| SLC51A \| DISEASES 128 \| ADH5 \| DISEASES 327 \| APEH \| DISEASES 6690 \| SPINK1 \| DISEASES 7098 \| TLR3 \| DISEASES 27242 \| TNFRSF21 \| DISEASES 6469 \| SHH \| DISEASES 80270 \| HSD3B7 \| DISEASES 3990 \| LIPC \| DISEASES 79053 \| ALG8 \| DISEASES 290 \| ANPEP \| DISEASES 55957 \| LIN37 \| DISEASES 1581 \| CYP7A1 \| DISEASES 8772 \| FADD \| DISEASES 598 \| BCL2L1 \| DISEASES 3175 \| ONECUT1 \| DISEASES 3479 \| IGF1 \| DISEASES 9963 \| SLC23A1 \| DISEASES 54578 \| UGT1A6 \| DISEASES 5940 \| RBMY1A1 \| DISEASES 54658 \| UGT1A1 \| DISEASES 7363 \| UGT2B4 \| DISEASES 2525 \| FUT3 \| DISEASES 6579 \| SLCO1A2 \| DISEASES 54205 \| CYCS \| DISEASES 2752 \| GLUL \| DISEASES 2147 \| F2 \| DISEASES 3626 \| INHBC \| DISEASES 5644 \| PRSS1 \| DISEASES 5340 \| PLG \| DISEASES 1657 \| DMXL1 \| DISEASES 6169 \| RPL38 \| DISEASES 3265 \| HRAS \| DISEASES 6868 \| ADAM17 \| DISEASES 9420 \| CYP7B1 \| DISEASES 836 \| CASP3 \| DISEASES 358 \| AQP1 \| DISEASES 148229 \| ATP8B3 \| DISEASES 3172 \| HNF4A \| DISEASES 9153 \| SLC28A2 \| DISEASES 29926 \| GMPPA \| DISEASES 3170 \| FOXA2 \| DISEASES 10170 \| DHRS9 \| DISEASES 4233 \| MET \| DISEASES 6748 \| SSR4 \| DISEASES 4684 \| NCAM1 \| DISEASES 8630 \| HSD17B6 \| DISEASES 6936 \| GCFC2 \| DISEASES 1582 \| CYP8B1 \| DISEASES 1728 \| NQO1 \| DISEASES 28232 \| SLCO3A1 \| DISEASES 6863 \| TAC1 \| DISEASES 4018 \| LPA \| DISEASES 55 \| ACPP \| DISEASES 5179 \| PENK \| DISEASES 51733 \| UPB1 \| DISEASES 1555 \| CYP2B6 \| DISEASES 6794 \| STK11 \| DISEASES 5520 \| PPP2R2A \| DISEASES 4094 \| MAF \| DISEASES 400668 \| PRSS57 \| DISEASES 387775 \| SLC22A10 \| DISEASES 26276 \| VPS33B \| DISEASES 3855 \| KRT7 \| DISEASES 2811 \| GP1BA \| DISEASES 9021 \| SOCS3 \| DISEASES 2520 \| GAST \| DISEASES 222546 \| RFX6 \| DISEASES 286410 \| ATP11C \| DISEASES 4088 \| SMAD3 \| DISEASES 10057 \| ABCC5 \| DISEASES 2152 \| F3 \| DISEASES 10732 \| TCFL5 \| DISEASES 245908 \| DEFB105A \| DISEASES 84068 \| SLC10A7 \| DISEASES 504180 \| DEFB105B \| DISEASES 123264 \| SLC51B \| DISEASES 2938 \| GSTA1 \| DISEASES 885 \| CCK \| DISEASES 8856 \| NR1I2 \| DISEASES 9075 \| CLDN2 \| DISEASES 1174 \| AP1S1 \| DISEASES 226 \| ALDOA \| DISEASES 1908 \| EDN3 \| DISEASES 9376 \| SLC22A8 \| DISEASES 1576 \| CYP3A4 \| DISEASES 23436 \| CELA3B \| DISEASES 7430 \| EZR \| DISEASES 63894 \| VIPAS39 \| DISEASES 11188 \| NISCH \| DISEASES 6609 \| SMPD1 \| DISEASES 4089 \| SMAD4 \| DISEASES 1528 \| CYB5A \| DISEASES 1544 \| CYP1A2 \| DISEASES 1508 \| CTSB \| DISEASES 1364 \| CLDN4 \| DISEASES 5962 \| RDX \| DISEASES 6672 \| SP100 \| DISEASES 3146 \| HMGB1 \| DISEASES 2100 \| ESR2 \| DISEASES 3605 \| IL17A \| DISEASES 285193 \| DUSP28 \| DISEASES 9962 \| SLC23A2 \| DISEASES 1499 \| CTNNB1 \| DISEASES 3516 \| RBPJ \| DISEASES 84706 \| GPT2 \| DISEASES 2534 \| FYN \| DISEASES 954 \| ENTPD2 \| DISEASES 100506658 \| OCLN \| DISEASES 161291 \| TMEM30B \| DISEASES 5265 \| SERPINA1 \| DISEASES 10656 \| KHDRBS3 \| DISEASES 3240 \| HP \| DISEASES 120 \| ADD3 \| DISEASES 79876 \| UBA5 \| DISEASES 60 \| ACTB \| DISEASES 162 \| AP1B1 \| DISEASES 9586 \| CREB5 \| DISEASES 4097 \| MAFG \| DISEASES 337 \| APOA4 \| DISEASES 26136 \| TES \| DISEASES 6714 \| SRC \| DISEASES 51592 \| TRIM33 \| DISEASES 841 \| CASP8 \| DISEASES 617 \| BCS1L \| DISEASES 5599 \| MAPK8 \| DISEASES 1803 \| DPP4 \| DISEASES 26580 \| BSCL2 \| DISEASES 10724 \| MGEA5 \| DISEASES 2705 \| GJB1 \| DISEASES 3880 \| KRT19 \| DISEASES 23038 \| WDTC1 \| DISEASES 22977 \| AKR7A3 \| DISEASES 22796 \| COG2 \| DISEASES 28514 \| DLL1 \| DISEASES 6580 \| SLC22A1 \| DISEASES 2494 \| NR5A2 \| DISEASES 462 \| SERPINC1 \| DISEASES 356 \| FASLG \| DISEASES 1490 \| CTGF \| DISEASES 9970 \| NR1I3 \| DISEASES 336 \| APOA2 \| DISEASES 632 \| BGLAP \| DISEASES 57198 \| ATP8B2 \| DISEASES 5406 \| PNLIP \| DISEASES 8517 \| IKBKG \| DISEASES 26576 \| SRPK3 \| DISEASES 2730 \| GCLM \| DISEASES 6319 \| SCD \| DISEASES 84548 \| TMEM185A \| DISEASES 1244 \| ABCC2 \| DISEASES 2805 \| GOT1 \| DISEASES 959 \| CD40LG \| DISEASES 1491 \| CTH \| DISEASES 5314 \| PKHD1 \| DISEASES 1791 \| DNTT \| DISEASES 3725 \| JUN \| DISEASES 7422 \| VEGFA \| DISEASES 84293 \| FAM213A \| DISEASES 4143 \| MAT1A \| DISEASES 4318 \| MMP9 \| DISEASES 9682 \| KDM4A \| DISEASES 10864 \| SLC22A7 \| DISEASES 54657 \| UGT1A4 \| DISEASES 5292 \| PIM1 \| DISEASES 7099 \| TLR4 \| DISEASES 51230 \| PHF20 \| DISEASES 1896 \| EDA \| DISEASES 249 \| ALPL \| DISEASES 229 \| ALDOB \| DISEASES 6048 \| RNF5 \| DISEASES 3055 \| HCK \| DISEASES 50943 \| FOXP3 \| DISEASES 3105 \| HLA-A \| DISEASES 10257 \| ABCC4 \| DISEASES 8718 \| TNFRSF25 \| DISEASES 9356 \| SLC22A6 \| DISEASES 1906 \| EDN1 \| DISEASES 3096 \| HIVEP1 \| DISEASES 3801 \| KIFC3 \| DISEASES 3440 \| IFNA2 \| DISEASES 3030 \| HADHA \| DISEASES 51284 \| TLR7 \| DISEASES 53919 \| SLCO1C1 \| DISEASES 51761 \| ATP8A2 \| DISEASES 10396 \| ATP8A1 \| DISEASES 80333 \| KCNIP4 \| DISEASES 6624 \| FSCN1 \| DISEASES 2235 \| FECH \| DISEASES 3875 \| KRT18 \| DISEASES 238 \| ALK \| DISEASES 2524 \| FUT2 \| DISEASES 250 \| ALPP \| DISEASES 2172 \| FABP6 \| DISEASES 8513 \| LIPF \| DISEASES 2875 \| GPT \| DISEASES 594855 \| CPLX3 \| DISEASES 6696 \| SPP1 \| DISEASES 174 \| AFP \| DISEASES 4780 \| NFE2L2 \| DISEASES 594857 \| NPS \| DISEASES 4599 \| MX1 \| DISEASES 4363 \| ABCC1 \| DISEASES 2825 \| GPR1 \| DISEASES 221938 \| MMD2 \| DISEASES 728441 \| GGT2 \| DISEASES 7018 \| TF \| DISEASES 2641 \| GCG \| DISEASES 8604 \| SLC25A12 \| DISEASES 10134 \| BCAP31 \| DISEASES 6915 \| TBXA2R \| DISEASES 388552 \| BLOC1S3 \| DISEASES 7124 \| TNF \| DISEASES 10165 \| SLC25A13 \| DISEASES 147372 \| CCBE1 \| DISEASES 6522 \| SLC4A2 \| DISEASES 51014 \| TMED7 \| DISEASES 9060 \| PAPSS2 \| DISEASES 4588 \| MUC6 \| DISEASES 283337 \| ZNF740 \| DISEASES 3586 \| IL10 \| DISEASES 83939 \| EIF2A \| DISEASES 54659 \| UGT1A3 \| DISEASES 2128 \| EVX1 \| DISEASES 6256 \| RXRA \| DISEASES 2939 \| GSTA2 \| DISEASES 7019 \| TFAM \| DISEASES 7511 \| XPNPEP1 \| DISEASES 151306 \| GPBAR1 \| DISEASES 51312 \| SLC25A37 \| DISEASES 9414 \| TJP2 \| DISEASES 55733 \| HHAT \| DISEASES 23263 \| MCF2L \| DISEASES 3684 \| ITGAM \| DISEASES 5365 \| PLXNB3 \| DISEASES 136541 \| PRSS58 \| DISEASES 9971 \| NR1H4 \| DISEASES 7421 \| VDR \| DISEASES 8972 \| MGAM \| DISEASES 10577 \| NPC2 \| DISEASES 57119 \| EPPIN \| DISEASES 11245 \| GPR176 \| DISEASES 2585 \| GALK2 \| DISEASES 344 \| APOC2 \| DISEASES 9294 \| S1PR2 \| DISEASES 284424 \| MIR7-3HG \| DISEASES 677807 \| SNORA22 \| DISEASES
Locus	(Waiting for update.)

Disease ID	524
Disease	cholestasis
Integrated Phenotype	(Waiting for update.)
Text Mined Phenotype	HPO \| Name \| Sentences' Count(Total Phenotypes:80) HP:0012115 \| Liver inflammation \| 27 HP:0000952 \| Yellow skin \| 19 HP:0000989 \| pruritis \| 15 HP:0001394 \| Hepatic cirrhosis \| 13 HP:0001399 \| Liver failure \| 6 HP:0002613 \| Biliary cirrhosis \| 6 HP:0200119 \| Acute liver inflammation \| 5 HP:0002904 \| High blood bilirubin levels \| 4 HP:0002240 \| Enlarged liver \| 3 HP:0003124 \| Elevated serum cholesterol \| 3 HP:0001410 \| Decreased liver function \| 3 HP:0001081 \| Gallstones \| 3 HP:0002024 \| Intestinal malabsorption \| 3 HP:0011675 \| Arrhythmias \| 2 HP:0001408 \| Proliferation of bile canaliculi \| 2 HP:0003155 \| Hyperphosphatasia \| 2 HP:0200034 \| Papule \| 2 HP:0012531 \| Pain \| 2 HP:0200123 \| Chronic liver inflammation \| 2 HP:0001733 \| Pancreatic inflammation \| 2 HP:0030151 \| Cholangitis \| 2 HP:0002748 \| Rickets \| 1 HP:0003256 \| Coagulopathy \| 1 HP:0006562 \| Viral hepatitis \| 1 HP:0100806 \| Sepsis \| 1 HP:0005912 \| Biliary duct atresia \| 1 HP:0002354 \| Memory loss \| 1 HP:0004387 \| Enterocolitis \| 1 HP:0001082 \| Cholecystitis \| 1 HP:0001903 \| Anemia \| 1 HP:0001642 \| Pulmonic stenosis \| 1 HP:0006580 \| Portal fibrosis \| 1 HP:0011985 \| Discolored, acholic stools \| 1 HP:0002665 \| Lymphoma \| 1 HP:0002960 \| Autoimmune condition \| 1 HP:0000083 \| Renal insufficiency \| 1 HP:0100727 \| Histiocytosis \| 1 HP:0001824 \| Weight loss \| 1 HP:0008221 \| Enlarged adrenal glands \| 1 HP:0100890 \| Cyst of the ductus choledochus \| 1 HP:0005230 \| Biliary tract obstruction \| 1 HP:0011854 \| Hemoperitoneum \| 1 HP:0000846 \| Hypoadrenalism \| 1 HP:0001789 \| Hydrops fetalis \| 1 HP:0000969 \| Dropsy \| 1 HP:0002027 \| Abdominal pain \| 1 HP:0001511 \| Prenatal onset growth retardation \| 1 HP:0001919 \| Acute renal failure \| 1 HP:0006579 \| Neonatal jaundice \| 1 HP:0030153 \| Cholangiocarcinoma \| 1 HP:0001404 \| Hepatocellular necrosis \| 1 HP:0012378 \| Fatigue \| 1 HP:0002570 \| Steatorrhea \| 1 HP:0001638 \| Cardiomyopathy \| 1 HP:0001635 \| Congestive heart failure \| 1 HP:0001518 \| Small for gestational age \| 1 HP:0011892 \| Vitamin K deficiency \| 1 HP:0004755 \| Supraventricular tachycardia \| 1 HP:0001541 \| Ascites \| 1 HP:0001510 \| Growth deficiency \| 1 HP:0100522 \| Thymoma \| 1 HP:0001397 \| Hepatic steatosis \| 1 HP:0000078 \| Genital abnormalities \| 1 HP:0004756 \| Ventricular tachycardia \| 1 HP:0002884 \| Hepatoblastoma \| 1 HP:0001414 \| Microvesicular hepatic steatosis \| 1 HP:0100512 \| Vitamin D deficiency \| 1 HP:0012125 \| Prostate cancer \| 1 HP:0001004 \| Lymphatic obstruction \| 1 HP:0001945 \| Fever \| 1 HP:0002664 \| Neoplasia \| 1 HP:0004969 \| peripheral pulmonary stenosis \| 1 HP:0002910 \| Elevated transaminases \| 1 HP:0004395 \| Malnutrition \| 1 HP:0001405 \| Periportal fibrosis \| 1 HP:0004763 \| Episodic supraventricular tachycardia \| 1 HP:0009800 \| gestational diabetes \| 1 HP:0001433 \| Enlarged liver and spleen \| 1 HP:0005584 \| Renal cell carcinoma \| 1 HP:0000836 \| Overactive thyroid \| 1

Disease ID	524
Disease	cholestasis
Manually Symptom	(Waiting for update.)
Text Mined Symptom	UMLS \| Name \| Sentences' Count(Total Symptoms:18) C0022346 \| jaundice \| 19 C0033774 \| pruritus \| 12 C0023895 \| liver disease \| 7 C0020433 \| hyperbilirubinemia \| 4 C0235378 \| hepatotoxicity \| 4 C0033774 \| pruritis \| 3 C0020443 \| hypercholesterolemia \| 3 C0027613 \| neonatal hepatitis \| 2 C0267818 \| bile duct proliferation \| 2 C0030305 \| pancreatitis \| 2 C0008350 \| cholelithiasis \| 2 C0042880 \| vitamin k deficiency \| 1 C0015672 \| fatigue \| 1 C0022116 \| ischemia \| 1 C0206698 \| cholangiocarcinoma \| 1 C0035579 \| rickets \| 1 C1393529 \| vascular complications \| 1 C0426768 \| o sign \| 1

Manually Genotype(Total Text Mining Genotypes:0)
(Waiting for update.)

All Snps(Total Genotypes:4)
snpId	pubmedId	geneId	geneSymbol	diseaseId	sourceId	sentence	score	Year	geneSymbol_dbSNP	CHROMOSOME	POS	REF	ALT
rs1799971	18709298	4988	OPRM1	umls:C0008370	BeFree	The possibility of protection from pruritus associated with A118G supports the study of genetic polymorphisms of the OPRM1 gene in patients with cholestasis.	0.000271442	2008	OPRM1	6	154039662	A	G
rs2230028	19998509	5244	ABCB4	umls:C0008370	BeFree	Multidrug resistance protein 3 R652G may reduce susceptibility to idiopathic infant cholestasis.	0.094354082	2009	ABCB4	7	87426860	T	G,C
rs2287622	21320040	8647	ABCB11	umls:C0008370	BeFree	A common variant of BSEP (p.V444A) is now a well-established susceptibility factor for acquired cholestasis and recent evidence suggests that the same variant also influences the therapeutic response and disease progression of viral hepatitis C. Studies in large independent cohorts are now needed to confirm the relevance of p.V444A.	0.213420204	2011	ABCB11	2	168973818	A	T,G,C
rs72552778	24806754	5244	ABCB4	umls:C0008370	BeFree	ABCB4(S320F) homozygosity, with half the normal level of ABCB4, is the tipping point between more benign and potentially fatal cholestasis and makes these patients more acutely sensitive to environmental effects.	0.094354082	2013	ABCB4	7	87447080	G	A

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:91)
CUI	ChemicalName	ChemicalID	CasRN	DiseaseName	DiseaseID	DirectEvidence	PubMedIDs
C0008370	acetaminophen	D000082	103-90-2	cholestasis	MESH:D002779	marker/mechanism	11315774
C0008370	acetohexamide	D000092	968-81-0	cholestasis	MESH:D002779	marker/mechanism	2714585
C0008370	acitretin	D017255	55079-83-9	cholestasis	MESH:D002779	marker/mechanism	11922592
C0008370	s-adenosylmethionine	D012436	29908-03-0	cholestasis	MESH:D002779	marker/mechanism	7450400
C0008370	s-adenosylmethionine	D012436	29908-03-0	cholestasis	MESH:D002779	therapeutic	11281545
C0008370	amitriptyline	D000639	50-48-6	cholestasis	MESH:D002779	marker/mechanism	11092117
C0008370	ampicillin	D000667	69-53-4	cholestasis	MESH:D002779	marker/mechanism	12639171
C0008370	atenolol	D001262	29122-68-7	cholestasis	MESH:D002779	marker/mechanism	2773903
C0008370	bupivacaine	D002045	2180-92-9	cholestasis	MESH:D002779	marker/mechanism	8484525
C0008370	busulfan	D002066	55-98-1	cholestasis	MESH:D002779	marker/mechanism	3376924
C0008370	butorphanol	D002077	42408-82-2	cholestasis	MESH:D002779	marker/mechanism	6537876
C0008370	carbamazepine	D002220	298-46-4	cholestasis	MESH:D002779	marker/mechanism	11837721
C0008370	carbimazole	D002231	22232-54-8	cholestasis	MESH:D002779	marker/mechanism	12201214
C0008370	carmustine	D002330	154-93-8	cholestasis	MESH:D002779	marker/mechanism	10445391
C0008370	cefotaxime	D002439	63527-52-6	cholestasis	MESH:D002779	marker/mechanism	19321684
C0008370	cefotaxime	D002439	63527-52-6	cholestasis	MESH:D002779	therapeutic	17530386
C0008370	celecoxib	D000068579	-	cholestasis	MESH:D002779	marker/mechanism	16518289
C0008370	cephalexin	D002506	15686-71-2	cholestasis	MESH:D002779	marker/mechanism	15365421
C0008370	cerivastatin	C086276	-	cholestasis	MESH:D002779	marker/mechanism	12042141
C0008370	chlorambucil	D002699	305-03-3	cholestasis	MESH:D002779	marker/mechanism	11319447
C0008370	chlordiazepoxide	D002707	58-25-3	cholestasis	MESH:D002779	marker/mechanism	4952749
C0008370	chlorpromazine	D002746	50-53-3	cholestasis	MESH:D002779	marker/mechanism	110598
C0008370	chlorpromazine	D002746	50-53-3	cholestasis	MESH:D002779	therapeutic	572556
C0008370	cimetidine	D002927	51481-61-9	cholestasis	MESH:D002779	marker/mechanism	3816488
C0008370	cinnarizine	D002936	298-57-7	cholestasis	MESH:D002779	marker/mechanism	10190745
C0008370	ciprofloxacin	D002939	85721-33-1	cholestasis	MESH:D002779	marker/mechanism	12399240
C0008370	citalopram	D015283	59729-33-8	cholestasis	MESH:D002779	marker/mechanism	12524417
C0008370	clotrimazole	D003022	23593-75-1	cholestasis	MESH:D002779	marker/mechanism	1608283
C0008370	clozapine	D003024	5786-21-0	cholestasis	MESH:D002779	marker/mechanism	2884090
C0008370	colchicine	D003078	64-86-8	cholestasis	MESH:D002779	marker/mechanism	15318531
C0008370	creatine	D003401	57-00-1	cholestasis	MESH:D002779	marker/mechanism	18452122
C0008370	cyclophosphamide	D003520	50-18-0	cholestasis	MESH:D002779	marker/mechanism	17786148
C0008370	cyclosporine	D016572	59865-13-3	cholestasis	MESH:D002779	marker/mechanism	1570353
C0008370	cyclosporine	D016572	59865-13-3	cholestasis	MESH:D002779	therapeutic	8895755
C0008370	cyproheptadine	D003533	129-03-3	cholestasis	MESH:D002779	marker/mechanism	3559100
C0008370	dapsone	D003622	80-08-0	cholestasis	MESH:D002779	marker/mechanism	11996898
C0008370	diclofenac	D004008	15307-86-5	cholestasis	MESH:D002779	marker/mechanism	10916496
C0008370	dicloxacillin	D004009	3116-76-5	cholestasis	MESH:D002779	marker/mechanism	3701014
C0008370	disopyramide	D004206	3737/9/5	cholestasis	MESH:D002779	marker/mechanism	7396302
C0008370	enalapril	D004656	75847-73-3	cholestasis	MESH:D002779	marker/mechanism	12420643
C0008370	enflurane	D004737	13838-16-9	cholestasis	MESH:D002779	marker/mechanism	3608133
C0008370	erythromycin	D004917	114-07-8	cholestasis	MESH:D002779	therapeutic	572556
C0008370	everolimus	D000068338	-	cholestasis	MESH:D002779	marker/mechanism	19955336
C0008370	floxuridine	D005467	50-91-9	cholestasis	MESH:D002779	marker/mechanism	2937274
C0008370	flutamide	D005485	13311-84-7	cholestasis	MESH:D002779	marker/mechanism	17409513
C0008370	glimepiride	C057619	-	cholestasis	MESH:D002779	marker/mechanism	11173739
C0008370	glutathione	D005978	70-18-8	cholestasis	MESH:D002779	marker/mechanism	8377599
C0008370	griseofulvin	D006118	126-07-8	cholestasis	MESH:D002779	marker/mechanism	12735108
C0008370	hemin	D006427	16009-13-5	cholestasis	MESH:D002779	therapeutic	19085910
C0008370	imipramine	D007099	50-49-7	cholestasis	MESH:D002779	marker/mechanism	7429116
C0008370	indomethacin	D007213	53-86-1	cholestasis	MESH:D002779	marker/mechanism	3047224
C0008370	lovastatin	D008148	75330-75-5	cholestasis	MESH:D002779	marker/mechanism	2026107
C0008370	mefloquine	D015767	53230-10-7	cholestasis	MESH:D002779	marker/mechanism	15983754
C0008370	metformin	D008687	657-24-9	cholestasis	MESH:D002779	marker/mechanism	14561576
C0008370	dextromethorphan	D003915	125-71-3	cholestasis	MESH:D002779	marker/mechanism	10592673
C0008370	methotrexate	D008727	1959/5/2	cholestasis	MESH:D002779	marker/mechanism	1775433
C0008370	metolazone	D008788	17560-51-9	cholestasis	MESH:D002779	marker/mechanism	11572578
C0008370	mitoxantrone	D008942	65271-80-9	cholestasis	MESH:D002779	marker/mechanism	19393848
C0008370	morphine	D009020	57-27-2	cholestasis	MESH:D002779	marker/mechanism	3421781
C0008370	nelfinavir	D019888	159989-64-7	cholestasis	MESH:D002779	marker/mechanism	11519908
C0008370	nevirapine	D019829	129618-40-2	cholestasis	MESH:D002779	marker/mechanism	26626330
C0008370	nitric oxide	D009569	10102-43-9	cholestasis	MESH:D002779	marker/mechanism	12612912
C0008370	levonorgestrel	D016912	797-63-7	cholestasis	MESH:D002779	marker/mechanism	15861022
C0008370	octreotide	D015282	83150-76-9	cholestasis	MESH:D002779	marker/mechanism	16283598
C0008370	ofloxacin	D015242	82419-36-1	cholestasis	MESH:D002779	therapeutic	8750178
C0008370	paclitaxel	D017239	-	cholestasis	MESH:D002779	therapeutic	8895755
C0008370	phenytoin	D010672	57-41-0	cholestasis	MESH:D002779	marker/mechanism	12630649
C0008370	piperacillin	D010878	61477-96-1	cholestasis	MESH:D002779	marker/mechanism	11422785
C0008370	piroxicam	D010894	36322-90-4	cholestasis	MESH:D002779	marker/mechanism	9731437
C0008370	pravastatin	D017035	81093-37-0	cholestasis	MESH:D002779	marker/mechanism	10235223
C0008370	prochlorperazine	D011346	58-38-8	cholestasis	MESH:D002779	marker/mechanism	14571732
C0008370	progesterone	D011374	57-83-0	cholestasis	MESH:D002779	marker/mechanism	9116778
C0008370	propylthiouracil	D011441	51-52-5	cholestasis	MESH:D002779	marker/mechanism	11144016
C0008370	ramipril	D017257	87333-19-5	cholestasis	MESH:D002779	marker/mechanism	14567716
C0008370	rifampin	D012293	13292-46-1	cholestasis	MESH:D002779	marker/mechanism	19577586
C0008370	ritonavir	D019438	-	cholestasis	MESH:D002779	marker/mechanism	9786823
C0008370	rofecoxib	C116926	-	cholestasis	MESH:D002779	marker/mechanism	15892770
C0008370	sirolimus	D020123	53123-88-9	cholestasis	MESH:D002779	therapeutic	20417810
C0008370	sulindac	D013467	38194-50-2	cholestasis	MESH:D002779	marker/mechanism	3866535
C0008370	sulpiride	D013469	15676-16-1	cholestasis	MESH:D002779	marker/mechanism	7582254
C0008370	tacrolimus	D016559	109581-93-3	cholestasis	MESH:D002779	marker/mechanism	16573611
C0008370	tacrolimus	D016559	109581-93-3	cholestasis	MESH:D002779	therapeutic	12826230
C0008370	tenoxicam	C032801	59804-37-4	cholestasis	MESH:D002779	marker/mechanism	12821054
C0008370	terfenadine	D016593	50679-08-8	cholestasis	MESH:D002779	marker/mechanism	8757175
C0008370	thalidomide	D013792	50-35-1	cholestasis	MESH:D002779	therapeutic	12923366
C0008370	ticlopidine	D013988	55142-85-3	cholestasis	MESH:D002779	marker/mechanism	10418941
C0008370	troglitazone	C057693	97322-87-7	cholestasis	MESH:D002779	marker/mechanism	11179459
C0008370	valproic acid	D014635	99-66-1	cholestasis	MESH:D002779	marker/mechanism	19239041
C0008370	vitamin a	D014801	11103-57-4	cholestasis	MESH:D002779	marker/mechanism	16175620
C0008370	adenine	D000225	73-24-5	cholestasis	MESH:D002779	marker/mechanism	946274
C0008370	vitamin e	D014810	1406-18-4	cholestasis	MESH:D002779	marker/mechanism	946274

FDA approved drug and dosage information(Total Drugs:24)
DiseaseID	Drug_name	active_ingredients	strength	Dosage Form/Route	Marketing Status	TE code	RLD	RS
MESH:D002779	mevacor	lovastatin	10MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET;ORAL	Discontinued	None	Yes	No
MESH:D002779	busulfex	busulfan	6MG/ML	INJECTABLE;INJECTION	Prescription	AP	Yes	Yes
MESH:D002779	cipro	ciprofloxacin	400MG/40ML (10MG/ML)	INJECTABLE;INJECTION	Discontinued	None	Yes	No
MESH:D002779	cipro	ciprofloxacin	250MG/5ML	FOR SUSPENSION;ORAL	Prescription	AB	Yes	No
MESH:D002779	vioxx	rofecoxib	12.5MG	TABLET;ORAL	Discontinued	None	No	No
MESH:D002779	vioxx	rofecoxib	12.5MG/5ML	SUSPENSION;ORAL	Discontinued	None	No	No
MESH:D002779	vioxx	rofecoxib	12.5MG	TABLET; ORAL	Discontinued	None	No	No
MESH:D002779	rapamune	sirolimus	1MG/ML	SOLUTION;ORAL	Prescription	None	Yes	Yes
MESH:D002779	rapamune	sirolimus	1MG	TABLET;ORAL	Prescription	AB	Yes	No
MESH:D002779	norvir	ritonavir	80MG/ML	SOLUTION;ORAL	Prescription	None	Yes	Yes
MESH:D002779	norvir	ritonavir	100MG	CAPSULE;ORAL	Discontinued	None	No	No
MESH:D002779	norvir	ritonavir	100MG	CAPSULE;ORAL	Prescription	None	Yes	Yes
MESH:D002779	norvir	ritonavir	100MG	TABLET;ORAL	Prescription	AB	Yes	Yes
MESH:D002779	amaryl	glimepiride	1MG	TABLET;ORAL	Prescription	AB	Yes	Yes
MESH:D002779	celebrex	celecoxib	100MG	CAPSULE;ORAL	Prescription	AB	Yes	No
MESH:D002779	celebrex	celecoxib	100MG	CAPSULE;ORAL	Prescription	None	No	No
MESH:D002779	mirena	levonorgestrel	52MG	INTRAUTERINE DEVICE;INTRAUTERINE	Prescription	None	Yes	Yes
MESH:D002779	levonorgestrel	levonorgestrel	75MG/IMPLANT	IMPLANT;IMPLANTATION	Discontinued	None	No	No
MESH:D002779	afinitor	everolimus	5MG	TABLET;ORAL	Prescription	None	Yes	No
MESH:D002779	ofirmev	acetaminophen	1GM/100ML (10MG/ML)	SOLUTION;IV (INFUSION)	Prescription	AP	Yes	Yes
MESH:D002779	ofirmev	acetaminophen	1GM/100ML (10MG/ML)	SOLUTION;IV (INFUSION)	Prescription	AP	Yes	Yes
MESH:D002779	acetaminophen	acetaminophen	650MG	SUPPOSITORY;RECTAL	Over-the-counter	None	Yes	Yes
MESH:D002779	acetaminophen	acetaminophen	650MG	SUPPOSITORY;RECTAL	Over-the-counter	None	Yes	Yes
MESH:D002779	inomax	nitric oxide	100PPM Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	GAS;INHALATION	Discontinued	None	Yes	No

FDA labeling changes(Total Drugs:24)
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:D002779	02/14/2002	mevacor	lovastatin	Heterozygous Familial Hypercholesterolemia	New indication in adolescent boys and girls (at least one year post-menarche) 10-17 years of age	Labeling	B	-	-	-	Merck	07/17/2001	FALSE'
MESH:D002779	01/13/2003	busulfex	busulfan	Part of a conditioning regimen administered prior to hematopoietic progenitor cell transplantation for a variety of malignant hematologic or non-malignant diseases	The population pharmacokinetic estimates of busulfan for clearance and volume of distribution were determined in an open-label, uncontrolled PK study in 24 pediatric patients 5 months to 16 years who received busulfan as part of a conditioning regimen administered prior to hematopoietic progenitor cell transplantation for a variety of malignant hematologic or non-malignant diseases Suggested dosing regimen	Labeling	B	-	-	-	Orphan Medical	12/3/2002	FALSE'
MESH:D002779	03/25/2004	cipro	ciprofloxacin	Complicated UTI and pyelonephritis	Indicated 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, respectively	Labeling	B	-	-	-	Bayer	12/18/2003	FALSE'
MESH:D002779	03/25/2004	cipro	ciprofloxacin	Complicated UTI and pyelonephritis	Indicated 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, respectively	Labeling	B	-	-	-	Bayer	12/18/2003	FALSE'
MESH:D002779	08/19/2004	vioxx	rofecoxib	Pauciarticular or polyarticular course Juvenile Rheumatoid Arthritis	Merck announced a voluntary worldwide withdrawal of Vioxx (rofecoxib) due to safety concerns on September 30, 2004.	Labeling	B	-	-	-	Merck	02/18/2004	FALSE'
MESH:D002779	08/19/2004	vioxx	rofecoxib	Pauciarticular or polyarticular course Juvenile Rheumatoid Arthritis	Merck announced a voluntary worldwide withdrawal of Vioxx (rofecoxib) due to safety concerns on September 30, 2004.	Labeling	B	-	-	-	Merck	02/18/2004	FALSE'
MESH:D002779	08/19/2004	vioxx	rofecoxib	Pauciarticular or polyarticular course Juvenile Rheumatoid Arthritis	Merck announced a voluntary worldwide withdrawal of Vioxx (rofecoxib) due to safety concerns on September 30, 2004.	Labeling	B	-	-	-	Merck	02/18/2004	FALSE'
MESH:D002779	11/3/2005	rapamune	sirolimus	Prophylaxis of organ rejection in patients undergoing renal transplants	Safety and efficacy established in children 13 years or older judged to be at low to moderate immunologic risk Safety was assessed in a controlled clinical trial in pediatric (	Labeling	B	-	-	-	Wyeth	11/17/2004	FALSE'
MESH:D002779	11/3/2005	rapamune	sirolimus	Prophylaxis of organ rejection in patients undergoing renal transplants	Safety and efficacy established in children 13 years or older judged to be at low to moderate immunologic risk Safety was assessed in a controlled clinical trial in pediatric (	Labeling	B	-	-	-	Wyeth	11/17/2004	FALSE'
MESH:D002779	6/10/2005	norvir	ritonavir	Treatment of HIV-infection in combination with other antiretroviral agents	Extended 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 parameters	Labeling	B	-	-	-	Abbott	06/14/2005	FALSE'
MESH:D002779	6/10/2005	norvir	ritonavir	Treatment of HIV-infection in combination with other antiretroviral agents	Extended 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 parameters	Labeling	B	-	-	-	Abbott	06/14/2005	FALSE'
MESH:D002779	6/10/2005	norvir	ritonavir	Treatment of HIV-infection in combination with other antiretroviral agents	Extended 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 parameters	Labeling	B	-	-	-	Abbott	06/14/2005	FALSE'
MESH:D002779	6/10/2005	norvir	ritonavir	Treatment of HIV-infection in combination with other antiretroviral agents	Extended 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 parameters	Labeling	B	-	-	-	Abbott	06/14/2005	FALSE'
MESH:D002779	11/28/2005	amaryl	glimepiride	Type-2 Diabetes Mellitus	Data are insufficient to recommend pediatric use of glimepiride In an active-controlled, single-blind, 24-week trial, 272 pediatric patients aged 8 to 17 years with Type 2 diabetes were randomized to treatment with glimepiride or metformin. Trial suggested differences favoring metformin AE profile in the pediatric population was similar to that for adults Information on PK parameters	Labeling	-	-	B, P	-	Aventis	9/6/2005	FALSE'
MESH:D002779	12/15/2006	celebrex	celecoxib	Relief 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, AEs	Labeling	B	-	-	-	Pfizer	08/23/2006	FALSE'
MESH:D002779	12/15/2006	celebrex	celecoxib	Relief 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, AEs	Labeling	B	-	-	-	Pfizer	08/23/2006	FALSE'
MESH:D002779	1/10/2009	mirena	levonorgestrel-releasing intrauterine system	Treatment of heavy menstrual bleeding for women using intrauterine contraception	New indication for the treatment of heavy menstrual bleeding for women who choose to use intrauterine contraception Use before menarche is not indicated	Labeling	-	P	-	-	Berlex	-	TRUE'
MESH:D002779	10/7/2009	plan b one step	levonorgestrel	Emergency contraception - OTC in women 17 years and older; RX for women younger than age 17 years	New single dose 1.5 mg tablet New dosage regimen	Labeling	-	P	-	-	Duramed	-	FALSE'
MESH:D002779	10/29/2010	afinitor	everolimus	Treatment of patients with subependymal giant cell astrocytoma (SEGA) associated with tuberous sclerosis	Approved for treatment of patients with SEGA associated with TS An open-label, single-arm safety and efficacy trial was conducted in 28 patients 3-34 years with SEGA associated with TS Afinitor has not been studied in patients with SEGA < 3 years of ageMost common adverse reactions (incidence e30%) were stomatitis, upper respiratory tract infection, sinusitis, otitis media, and pyrexiaDose reduction and/or treatment interruption may be needed to manage adverse drug reactions Information on starting dose, therapeutic drug monitoring, clinical trial, and adverse reactions New indication	Labeling	B	-	-	-	Novartis	-	FALSE'
MESH:D002779	2/11/2010	ofirmev	acetaminophen	Management of mild-to-moderate pain, for the management of moderate-to-severe pain with adjunctive opioid analgesics, and for the reduction of fever	The 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 administration	Labeling	-	P	-	-	Cadence	-	FALSE'
MESH:D002779	01/27/2017	ofirmev	acetaminophen	Treatmeny of pain and fever in pediatric patients birth to 2 years	Treatment 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	-	Mallinckrodt	11/7/2016	FALSE
MESH:D002779	2/11/2010	ofirmev	acetaminophen	Management of mild-to-moderate pain, for the management of moderate-to-severe pain with adjunctive opioid analgesics, and for the reduction of fever	The 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 administration	Labeling	-	P	-	-	Cadence	-	FALSE'
MESH:D002779	01/27/2017	ofirmev	acetaminophen	Treatmeny of pain and fever in pediatric patients birth to 2 years	Treatment 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	-	Mallinckrodt	11/7/2016	FALSE
MESH:D002779	12/21/2010	inomax	nitric oxide	Prevention of bronchopulmonary dysplasia	INOmax is not indicated for prevention of BPD in preterm neonates d 34 weeks gestational age.Efficacy for the prevention of BPD in preterm infants was not established in three ldouble-blind, placebo-controlled clinical trials in a total of 2,149 preterm infants Information on clinical trials, adverse reaction	Labeling	B	-	-	-	INO Therapeutics	2/11/2010	FALSE'