PedAM

Pediatric Disease Annotations & Medicines


	hypertriglyceridemia

Disease ID	703
Disease	hypertriglyceridemia
Definition	A condition of elevated levels of TRIGLYCERIDES in the blood.
Synonym	elevated triglycerides high triglycerides hyperglyceridaemia hyperglyceridemia hypertriglyceridaemia hypertriglyceridemia (disorder) hypertriglyceridemia [disease/finding] hypertriglyceridemias increased triglycerides raised triglycerides
UMLS	C0020557
MeSH	D015228
SNOMED-CT	SNOMEDCT_US_2016_09_01:302870006
Comorbidity	UMLS \| Disease \| Sentences' Count(Total Sentences:62) C0030305 \| pancreatitis \| 30 C0001339 \| acute pancreatitis \| 18 C0011847 \| diabetes \| 17 C0028754 \| obesity \| 12 C0948265 \| metabolic syndrome \| 12 C0011860 \| type 2 diabetes \| 9 C0020443 \| hypercholesterolemia \| 9 C0011849 \| diabetes mellitus \| 7 C0020459 \| hyperinsulinemia \| 5 C0042373 \| vascular disease \| 4 C0020456 \| hyperglycemia \| 4 C0007222 \| cardiovascular disease \| 4 C0004153 \| atherosclerosis \| 4 C0011860 \| type 2 diabetes mellitus \| 4 C0011880 \| diabetic ketoacidosis \| 4 C0018099 \| gout \| 3 C0740394 \| hyperuricemia \| 3 C0020538 \| hypertension \| 3 C0030312 \| pancytopenia \| 2 C0022661 \| chronic kidney disease \| 2 C0027726 \| nephrotic syndrome \| 2 C0032914 \| preeclampsia \| 2 C0028754 \| adiposity \| 2 C0040188 \| tic disorders \| 1 C0035309 \| retinopathy \| 1 C0221032 \| congenital generalized lipodystrophy \| 1 C0042373 \| vascular diseases \| 1 C0018995 \| hemochromatosis \| 1 C0003972 \| atherosclerotic cardiovascular disease \| 1 C0010068 \| coronary artery disease \| 1 C0149931 \| migraine \| 1 C1561644 \| chronic kidney disease (ckd) \| 1 C0023449 \| acute lymphoblastic leukemia \| 1 C0022661 \| chronic renal failure \| 1 C0541760 \| liver adenoma \| 1 C0221032 \| generalized lipodystrophy \| 1 C0035078 \| renal failure \| 1 C0027051 \| myocardial infarction \| 1 C0149521 \| recurrent pancreatitis \| 1 C0020676 \| hypothyroidism \| 1 C0013295 \| duodenal ulcer \| 1 C0040034 \| thrombocytopenia \| 1 C0033687 \| proteinuria \| 1 C0018799 \| heart disease \| 1 C0006142 \| breast cancer \| 1 C0221032 \| congenital lipodystrophy \| 1 C0442874 \| neuropathy \| 1 C0023787 \| lipodystrophy \| 1 C0022661 \| end-stage renal disease \| 1 C0029456 \| osteoporosis \| 1 C0023448 \| lymphoblastic leukemia \| 1 C0023817 \| lipoprotein lipase deficiency \| 1 C0010068 \| coronary heart disease \| 1 C0007222 \| cardiovascular diseases \| 1 C0022658 \| kidney disease \| 1 C0039730 \| thalassemia \| 1 C0159069 \| impaired glucose tolerance \| 1 C0023418 \| leukemia \| 1 C0027051 \| myocardial infarct \| 1 C0003850 \| arteriosclerosis \| 1 C0018799 \| heart diseases \| 1 C0011570 \| depression \| 1
Curated Gene	Entrez_id \| Symbol \| Resource(Total Genes:14) INS \| 3630 \| CTD_human CRP \| 1401 \| CTD_human PPARA \| 5465 \| CTD_human LPL \| 4023 \| CTD_human BCHE \| 590 \| CTD_human IFNA2 \| 3440 \| CTD_human GCKR \| 2646 \| CTD_human;GWASCAT APOB \| 338 \| CTD_human CETP \| 1071 \| CTD_human APOA5 \| 116519 \| CTD_human ZPR1 \| 8882 \| GWASCAT LMF1 \| 64788 \| CTD_human PLTP \| 5360 \| CTD_human TMEM241 \| 85019 \| GWASCAT
Inferring Gene	Entrez_id \| Symbol \| Resource(Total Genes:26) 38 \| ACAT1 \| infer 154 \| ADRB2 \| infer 27329 \| ANGPTL3 \| infer 335 \| APOA1 \| infer 336 \| APOA2 \| infer 337 \| APOA4 \| infer 116519 \| APOA5 \| infer 338 \| APOB \| infer 345 \| APOC3 \| infer 348 \| APOE \| infer 8542 \| APOL1 \| infer 9031 \| BAZ1B \| infer 1071 \| CETP \| infer 1581 \| CYP7A1 \| infer 5167 \| ENPP1 \| infer 2169 \| FABP2 \| infer 2590 \| GALNT2 \| infer 2646 \| GCKR \| infer 9388 \| LIPG \| infer 4023 \| LPL \| infer 51085 \| MLXIPL \| infer 5465 \| PPARA \| infer 5468 \| PPARG \| infer 6101 \| RP1 \| infer 26608 \| TBL2 \| infer 10221 \| TRIB1 \| infer
Text Mined Gene	(Waiting for update.)
Locus	(Waiting for update.)

Disease ID	703
Disease	hypertriglyceridemia
Integrated Phenotype	(Waiting for update.)
Text Mined Phenotype	HPO \| Name \| Sentences' Count(Total Phenotypes:64) HP:0001733 \| Pancreatic inflammation \| 30 HP:0001735 \| Acute pancreatitis \| 17 HP:0000855 \| Insulin resistance \| 13 HP:0001513 \| Obesity \| 12 HP:0003124 \| Elevated serum cholesterol \| 9 HP:0000819 \| Diabetes mellitus \| 7 HP:0000842 \| Elevated insulin level \| 5 HP:0002621 \| Atherosclerosis \| 5 HP:0001953 \| Diabetic ketosis \| 4 HP:0001013 \| Eruptive xanthomas \| 4 HP:0003074 \| High blood glucose \| 4 HP:0003233 \| Low HDL-cholesterol \| 4 HP:0001993 \| Ketoacidosis \| 3 HP:0000822 \| Hypertension \| 3 HP:0002149 \| Hyperuricemia \| 3 HP:0001997 \| Gout \| 3 HP:0001397 \| Hepatic steatosis \| 3 HP:0012743 \| Central obesity \| 2 HP:0100602 \| Pre-eclampsia \| 2 HP:0003146 \| Decreased circulating cholesterol level \| 2 HP:0001876 \| Low blood cell count \| 2 HP:0100543 \| Cognitive deficits \| 2 HP:0002027 \| Abdominal pain \| 2 HP:0012622 \| Chronic kidney disease \| 2 HP:0001945 \| Fever \| 2 HP:0001297 \| Cerebral vascular events \| 2 HP:0003774 \| End-stage renal failure \| 2 HP:0000100 \| Nephrosis \| 2 HP:0001873 \| Low platelet count \| 1 HP:0000716 \| Depression \| 1 HP:0005110 \| Atrial fibrillation \| 1 HP:0001677 \| Coronary artery disease \| 1 HP:0002140 \| Ischemic stroke \| 1 HP:0000939 \| Osteoporosis \| 1 HP:0001909 \| Leukemia \| 1 HP:0000833 \| Glucose intolerance \| 1 HP:0040216 \| Hypoinsulinemia \| 1 HP:0000821 \| Underactive thyroid \| 1 HP:0009125 \| Lipodystrophy \| 1 HP:0003077 \| Hyperlipidemia \| 1 HP:0100027 \| Recurring pancreatitis \| 1 HP:0003256 \| Coagulopathy \| 1 HP:0001658 \| Myocardial infarction \| 1 HP:0001410 \| Decreased liver function \| 1 HP:0002076 \| Migraine headaches \| 1 HP:0002634 \| Arteriosclerosis \| 1 HP:0000083 \| Renal insufficiency \| 1 HP:0001433 \| Enlarged liver and spleen \| 1 HP:0000159 \| Lip abnormality \| 1 HP:0002902 \| Hyponatremia \| 1 HP:0011900 \| Hypofibrinogenemia \| 1 HP:0002588 \| Duodenal ulcer \| 1 HP:0009064 \| Generalized lipodystrophy \| 1 HP:0008283 \| High blood insulin levels while fasting \| 1 HP:0006721 \| Acute lymphocytic leukemia \| 1 HP:0010980 \| Hyperlipoproteinemia \| 1 HP:0000488 \| Noninflammatory retina disease \| 1 HP:0003002 \| Breast carcinoma \| 1 HP:0100033 \| Tic disorder \| 1 HP:0002917 \| Low blood magnesium levels \| 1 HP:0001744 \| Splenomegaly \| 1 HP:0009059 \| Congenital generalized lipodystrophy \| 1 HP:0002910 \| Elevated transaminases \| 1 HP:0000093 \| Proteinuria \| 1

Disease ID	703
Disease	hypertriglyceridemia
Manually Symptom	(Waiting for update.)
Text Mined Symptom	(Waiting for update.)

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

All Snps(Total Genotypes:10)
snpId	pubmedId	geneId	geneSymbol	diseaseId	sourceId	sentence	score	Year	geneSymbol_dbSNP	CHROMOSOME	POS	REF	ALT
rs1260326	23505323	2646	GCKR	umls:C0020557	GWASCAT	Genomic study in Mexicans identifies a new locus for triglycerides and refines European lipid loci.	0.249468128	2013	GCKR	2	27508073	T	C
rs1260326	20657596	2646	GCKR	umls:C0020557	GAD	[Excess of rare variants in genes identified by genome-wide association study of hypertriglyceridemia.]	0.249468128	2010	GCKR	2	27508073	T	C
rs1260326	20657596	2646	GCKR	umls:C0020557	GWASCAT	Excess of rare variants in genes identified by genome-wide association study of hypertriglyceridemia.	0.249468128	2010	GCKR	2	27508073	T	C
rs4635554	20657596	338	APOB	umls:C0020557	GAD	[Excess of rare variants in genes identified by genome-wide association study of hypertriglyceridemia.]	0.129468128	2010	NA	2	21166787	T	G
rs7016880	20657596	4023	LPL	umls:C0020557	GAD	[Excess of rare variants in genes identified by genome-wide association study of hypertriglyceridemia.]	0.271145155	2010	NA	8	20019235	G	C
rs714052	20657596	9031	BAZ1B	umls:C0020557	GAD	[Excess of rare variants in genes identified by genome-wide association study of hypertriglyceridemia.]	0.002367032	2010	BAZ1B	7	73450539	A	G
rs964184	20657596	8882	ZPR1	umls:C0020557	GWASCAT	Excess of rare variants in genes identified by genome-wide association study of hypertriglyceridemia.	0.122367032	2010	ZPR1	11	116778201	G	C
rs964184	20657596	8882	ZPR1	umls:C0020557	GAD	[Excess of rare variants in genes identified by genome-wide association study of hypertriglyceridemia.]	0.122367032	2010	ZPR1	11	116778201	G	C
rs964184	23505323	8882	ZPR1	umls:C0020557	GWASCAT	Genomic study in Mexicans identifies a new locus for triglycerides and refines European lipid loci.	0.122367032	2013	ZPR1	11	116778201	G	C
rs9949617	23505323	85019	TMEM241	umls:C0020557	GWASCAT	Genomic study in Mexicans identifies a new locus for triglycerides and refines European lipid loci.	0.12	2013	TMEM241	18	23299253	C	T

GWASdb Annotation(Total Genotypes:0)
(Waiting for update.)

GWASdb Snp Trait(Total Genotypes:14)
CHR	POS	SNPID	REF	ALT	ORI_SNPID	PMID	P_VALUE	P_VALUE_TEXT	OR/BETA	CI95_TEXT	GWAS_INITIAL_SAMPLE_SIZE	SUB_POPULATION	SUPER_POPULATION	GWAS_TRAIT	HPO_ID	HPO_TERM	DO_ID	DO_TERM	MESH_ID	MESH_TERM	EFO_ID	EFO_TERM	DOLITE_TERM	RISK_ALLELE	PUBLICATION_TYPE	AA	GENE_SYMBOL	TYPE	REFGENE
2	21389659	rs4635554	T	G	rs4635554	20657596	2.00E-07	NA	1.67	[1.38-2.02]	463 European ancestry cases; 1,197 European ancestry controls	European(1660)	ALL(1660)	EUR(1660)	ALL(1660)	Hypertriglyceridemia	HPOID:0002155	Hypertriglyceridemia	DOID:0050527	familial hypertriglyceridemia	D015228	Hypertriglyceridemia	EFOID:0004530	hypertriglyceridemia	Metabolism disease	rs4635554-G	Research Support, N.I.H., Extramural	Research Support, Non-U.S. Gov't	T
2	27730940	rs1260326	T	C	rs1260326	20657596	7.00E-09	NA	1.75	[1.45-2.12]	463 European ancestry cases; 1,197 European ancestry controls	European(1660)	ALL(1660)	EUR(1660)	ALL(1660)	Hypertriglyceridemia	HPOID:0002155	Hypertriglyceridemia	DOID:0050527	familial hypertriglyceridemia	D015228	Hypertriglyceridemia	EFOID:0004530	hypertriglyceridemia	Metabolism disease	rs1260326-T	Research Support, N.I.H., Extramural	Research Support, Non-U.S. Gov't	C
2	27730940	rs1260326	T	C	rs1260326	23505323	2.00E-13	Hypertriglyceridemia	NA	NA	1122 Mexican cases; 1118 Mexican controls	Mexican(2240)	ALL(2240)	HIS(2240)	ALL(2240)	Hypertriglyceridemia	HPOID:0002155	Hypertriglyceridemia	DOID:0050527	familial hypertriglyceridemia	D015228	Hypertriglyceridemia	EFOID:0004530	hypertriglyceridemia	Metabolism disease	NA	Research Support, N.I.H., Extramural	C	GCKR
5	156464242	rs2036402	T	C	rs2036402	23505323	3.00E-06	Hypertriglyceridemia	NA	NA	1122 Mexican cases; 1118 Mexican controls	Mexican(2240)	ALL(2240)	HIS(2240)	ALL(2240)	Hypertriglyceridemia	HPOID:0002155	Hypertriglyceridemia	DOID:0050527	familial hypertriglyceridemia	D015228	Hypertriglyceridemia	EFOID:0004530	hypertriglyceridemia	Metabolism disease	NA	Research Support, N.I.H., Extramural	A	HAVCR1
7	72864869	rs714052	A	G	rs714052	20657596	3.00E-06	NA	2.27	[1.61-3.23]	463 European ancestry cases; 1,197 European ancestry controls	European(1660)	ALL(1660)	EUR(1660)	ALL(1660)	Hypertriglyceridemia	HPOID:0002155	Hypertriglyceridemia	DOID:0050527	familial hypertriglyceridemia	D015228	Hypertriglyceridemia	EFOID:0004530	hypertriglyceridemia	Metabolism disease	NA	Research Support, N.I.H., Extramural	Research Support, Non-U.S. Gov't	T
7	72987354	rs2286276	C	T	rs2286276	23505323	2.00E-06	Hypertriglyceridemia	NA	NA	1122 Mexican cases; 1118 Mexican controls	Mexican(2240)	ALL(2240)	HIS(2240)	ALL(2240)	Hypertriglyceridemia	HPOID:0002155	Hypertriglyceridemia	DOID:0050527	familial hypertriglyceridemia	D015228	Hypertriglyceridemia	EFOID:0004530	hypertriglyceridemia	Metabolism disease	NA	Research Support, N.I.H., Extramural	A	TBL2
8	19876746	rs7016880	G	C	rs7016880	20657596	2.00E-07	NA	3.13	[2.04-4.76]	463 European ancestry cases; 1,197 European ancestry controls	European(1660)	ALL(1660)	EUR(1660)	ALL(1660)	Hypertriglyceridemia	HPOID:0002155	Hypertriglyceridemia	DOID:0050527	familial hypertriglyceridemia	D015228	Hypertriglyceridemia	EFOID:0004530	hypertriglyceridemia	Metabolism disease	NA	Research Support, N.I.H., Extramural	Research Support, Non-U.S. Gov't	G
8	19928582	rs9644568	G	A	rs9644568	23505323	4.00E-11	Hypertriglyceridemia	NA	NA	1122 Mexican cases; 1118 Mexican controls	Mexican(2240)	ALL(2240)	HIS(2240)	ALL(2240)	Hypertriglyceridemia	HPOID:0002155	Hypertriglyceridemia	DOID:0050527	familial hypertriglyceridemia	D015228	Hypertriglyceridemia	EFOID:0004530	hypertriglyceridemia	Metabolism disease	NA	Research Support, N.I.H., Extramural	G	NA
8	22088432	rs12541335	A	G	rs12541335	23505323	7.00E-06	Hypertriglyceridemia	NA	NA	1122 Mexican cases; 1118 Mexican controls	Mexican(2240)	ALL(2240)	HIS(2240)	ALL(2240)	Hypertriglyceridemia	HPOID:0002155	Hypertriglyceridemia	DOID:0050527	familial hypertriglyceridemia	D015228	Hypertriglyceridemia	EFOID:0004530	hypertriglyceridemia	Metabolism disease	NA	Research Support, N.I.H., Extramural	G	PHYHIP
11	115943253	rs1426391	A	C	rs1426391	23505323	7.00E-06	Hypertriglyceridemia	NA	NA	1122 Mexican cases; 1118 Mexican controls	Mexican(2240)	ALL(2240)	HIS(2240)	ALL(2240)	Hypertriglyceridemia	HPOID:0002155	Hypertriglyceridemia	DOID:0050527	familial hypertriglyceridemia	D015228	Hypertriglyceridemia	EFOID:0004530	hypertriglyceridemia	Metabolism disease	NA	Research Support, N.I.H., Extramural	A	NA
11	116648917	rs964184	G	C	rs964184	20657596	5.00E-24	NA	3.28	[2.61-4.14]	463 European ancestry cases; 1,197 European ancestry controls	European(1660)	ALL(1660)	EUR(1660)	ALL(1660)	Hypertriglyceridemia	HPOID:0002155	Hypertriglyceridemia	DOID:0050527	familial hypertriglyceridemia	D015228	Hypertriglyceridemia	EFOID:0004530	hypertriglyceridemia	Metabolism disease	rs964184-G	Research Support, N.I.H., Extramural	Research Support, Non-U.S. Gov't	C
11	116648917	rs964184	G	C	rs964184	23505323	5.00E-35	Hypertriglyceridemia	NA	NA	1122 Mexican cases; 1118 Mexican controls	Mexican(2240)	ALL(2240)	HIS(2240)	ALL(2240)	Hypertriglyceridemia	HPOID:0002155	Hypertriglyceridemia	DOID:0050527	familial hypertriglyceridemia	D015228	Hypertriglyceridemia	EFOID:0004530	hypertriglyceridemia	Metabolism disease	NA	Research Support, N.I.H., Extramural	C	NA
15	31215935	rs7178375	C	T	rs7178375	23505323	6.00E-06	Hypertriglyceridemia	NA	NA	1122 Mexican cases; 1118 Mexican controls	Mexican(2240)	ALL(2240)	HIS(2240)	ALL(2240)	Hypertriglyceridemia	HPOID:0002155	Hypertriglyceridemia	DOID:0050527	familial hypertriglyceridemia	D015228	Hypertriglyceridemia	EFOID:0004530	hypertriglyceridemia	Metabolism disease	NA	Research Support, N.I.H., Extramural	C	FAN1
18	20879217	rs9949617	C	T	rs9949617	23505323	2.00E-08	Hypertriglyceridemia	NA	NA	1122 Mexican cases; 1118 Mexican controls	Mexican(2240)	ALL(2240)	HIS(2240)	ALL(2240)	Hypertriglyceridemia	HPOID:0002155	Hypertriglyceridemia	DOID:0050527	familial hypertriglyceridemia	D015228	Hypertriglyceridemia	EFOID:0004530	hypertriglyceridemia	Metabolism disease	NA	Research Support, N.I.H., Extramural	T	TMEM241

Mapped by lexical matching(Total Items:0)
(Waiting for update.)

Mapped by homologous gene(Total Items:0)
(Waiting for update.)

Chemical(Total Drugs:20)
CUI	ChemicalName	ChemicalID	CasRN	DiseaseName	DiseaseID	DirectEvidence	PubMedIDs
C0020557	atenolol	D001262	29122-68-7	hypertriglyceridemia	MESH:D015228	marker/mechanism	1981077
C0020557	bexarotene	C095105	-	hypertriglyceridemia	MESH:D015228	marker/mechanism	21163938
C0020557	cyclosporine	D016572	59865-13-3	hypertriglyceridemia	MESH:D015228	marker/mechanism	11583721
C0020557	diethylstilbestrol	D004054	56-53-1	hypertriglyceridemia	MESH:D015228	marker/mechanism	1145147
C0020557	everolimus	D000068338	-	hypertriglyceridemia	MESH:D015228	marker/mechanism	10551636
C0020557	indinavir	D019469	150378-17-9	hypertriglyceridemia	MESH:D015228	marker/mechanism	11545549
C0020557	lovastatin	D008148	75330-75-5	hypertriglyceridemia	MESH:D015228	therapeutic	15159270
C0020557	metformin	D008687	657-24-9	hypertriglyceridemia	MESH:D015228	therapeutic	22627169
C0020557	nicotine	D009538	-	hypertriglyceridemia	MESH:D015228	marker/mechanism	24368177
C0020557	olanzapine	C076029	132539-06-1	hypertriglyceridemia	MESH:D015228	marker/mechanism	11442886
C0020557	pravastatin	D017035	81093-37-0	hypertriglyceridemia	MESH:D015228	therapeutic	10751747
C0020557	ritonavir	D019438	-	hypertriglyceridemia	MESH:D015228	marker/mechanism	11545549
C0020557	sirolimus	D020123	53123-88-9	hypertriglyceridemia	MESH:D015228	marker/mechanism	10221490
C0020557	streptozocin	D013311	18883-66-4	hypertriglyceridemia	MESH:D015228	marker/mechanism	20696151
C0020557	tacrolimus	D016559	109581-93-3	hypertriglyceridemia	MESH:D015228	marker/mechanism	11583721
C0020557	temsirolimus	C401859	-	hypertriglyceridemia	MESH:D015228	marker/mechanism	20430774
C0020557	tretinoin	D014212	302-79-4	hypertriglyceridemia	MESH:D015228	marker/mechanism	10741706
C0020557	troglitazone	C057693	97322-87-7	hypertriglyceridemia	MESH:D015228	therapeutic	11768731
C0020557	vitamin a	D014801	11103-57-4	hypertriglyceridemia	MESH:D015228	marker/mechanism	4045180
C0020557	riboflavin	D012256	83-88-5	hypertriglyceridemia	MESH:D015228	therapeutic	17425952

FDA approved drug and dosage information(Total Drugs:13)
DiseaseID	Drug_name	active_ingredients	strength	Dosage Form/Route	Marketing Status	TE code	RLD	RS
MESH:D015228	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:D015228	rapamune	sirolimus	1MG/ML	SOLUTION;ORAL	Prescription	None	Yes	Yes
MESH:D015228	rapamune	sirolimus	1MG	TABLET;ORAL	Prescription	AB	Yes	No
MESH:D015228	norvir	ritonavir	80MG/ML	SOLUTION;ORAL	Prescription	None	Yes	Yes
MESH:D015228	norvir	ritonavir	100MG	CAPSULE;ORAL	Discontinued	None	No	No
MESH:D015228	norvir	ritonavir	100MG	CAPSULE;ORAL	Prescription	None	Yes	Yes
MESH:D015228	norvir	ritonavir	100MG	TABLET;ORAL	Prescription	AB	Yes	Yes
MESH:D015228	zyprexa	olanzapine	2.5MG	TABLET;ORAL	Prescription	AB	Yes	No
MESH:D015228	zyprexa	olanzapine	10MG/VIAL	INJECTABLE;INTRAMUSCULAR	Prescription	AP	Yes	Yes
MESH:D015228	zyprexa	olanzapine	2.5MG	TABLET;ORAL	Prescription	AB	Yes	No
MESH:D015228	zyprexa	olanzapine	10MG/VIAL	INJECTABLE;INTRAMUSCULAR	Prescription	AP	Yes	Yes
MESH:D015228	afinitor	everolimus	5MG	TABLET;ORAL	Prescription	None	Yes	No
MESH:D015228	torisel	temsirolimus	25MG/ML (25MG/ML)	SOLUTION;INTRAVENOUS	Prescription	None	Yes	Yes

FDA labeling changes(Total Drugs:13)
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:D015228	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:D015228	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:D015228	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:D015228	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:D015228	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:D015228	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:D015228	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:D015228	08/14/2008	zyprexa	olanzapine	schizophrenia; bipolar disorder	Safety and effectiveness have not been established for patients less than 18 years of age In an analysis of placebo-controlled olanzapine monotherapy studies of adolescent patients, including those with schizophrenia or bipolar disorder, olanzapine was associated with: oHyperglycemia - a statistically significantly greater mean change in fasting glucose levels compared to placebo oHyperlipidemia statistically significant increases compared to placebo in fasting triglycerides, fasting total cholesterol and fasting LDL cholesterol oWeight gain olanzapine treated patients gained an average of 4.6 kg, compared to an average of 0.3 kg in placebo-treated patients with a median exposure of 3 weeks; Average weight gain during long-term therapy was 7.4 kg	-	B	-	-	-	Lilly	10/1/2007	FALSE'
MESH:D015228	08/14/2008	zyprexa	olanzapine	schizophrenia; bipolar disorder	Safety and effectiveness have not been established for patients less than 18 years of age In an analysis of placebo-controlled olanzapine monotherapy studies of adolescent patients, including those with schizophrenia or bipolar disorder, olanzapine was associated with: oHyperglycemia - a statistically significantly greater mean change in fasting glucose levels compared to placebo oHyperlipidemia statistically significant increases compared to placebo in fasting triglycerides, fasting total cholesterol and fasting LDL cholesterol oWeight gain olanzapine treated patients gained an average of 4.6 kg, compared to an average of 0.3 kg in placebo-treated patients with a median exposure of 3 weeks; Average weight gain during long-term therapy was 7.4 kg	-	B	-	-	-	Lilly	10/1/2007	FALSE'
MESH:D015228	4/12/2009	zyprexa	olanzapine	Treatment of manic or mixed episodes of bipolar I disorder and schizophrenia in adolescents ages 13-17	Extended schizophrenia and manic or mixed episodes of bipolar I disorder indications from adults to adolescents 1317 years of age Safety and effectiveness in children < 13 years of age have not been established Recommended starting dose for adolescents is lower than that for adults Compared to patients from adult clinical trials, adolescents were likely to gain more weight, experience increased sedation, and have greater increases in total cholesterol, triglycerides, LDL cholesterol, prolactin and hepatic transaminase levels Information on dosing, adverse reactions, pharmacokinetics, clinical studies	Labeling	B	-	-	-	Lilly	10/1/2007	TRUE'
MESH:D015228	4/12/2009	zyprexa	olanzapine	Treatment of manic or mixed episodes of bipolar I disorder and schizophrenia in adolescents ages 13-17	Extended schizophrenia and manic or mixed episodes of bipolar I disorder indications from adults to adolescents 1317 years of age Safety and effectiveness in children < 13 years of age have not been established Recommended starting dose for adolescents is lower than that for adults Compared to patients from adult clinical trials, adolescents were likely to gain more weight, experience increased sedation, and have greater increases in total cholesterol, triglycerides, LDL cholesterol, prolactin and hepatic transaminase levels Information on dosing, adverse reactions, pharmacokinetics, clinical studies	Labeling	B	-	-	-	Lilly	10/1/2007	TRUE'
MESH:D015228	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:D015228	05/30/2012	torisel	temsirolimus	Advanced recurrent/refractory solid tumors	Effectiveness in pediatric patients has not been established Torisel was studied in 59 patients 1 - 17 years and 12 patients 18 to 21 years in a phase 1-2 safety and exploratory pharmacodynamic study Adverse reactions were similar to those observedd in adults Information on dosing, clinical trials and PK parameters	Labeling	B	-	-	-	-	-	FALSE'