PedAM
Pediatric Disease Annotations & Medicines
| restless legs syndrome | ||||
| Disease ID | 279 |
|---|---|
| Disease | restless legs syndrome |
| Manually Symptom | (Waiting for update.) |
| Text Mined Symptom | UMLS | Name | Sentences' Count(Total Symptoms:7) C0162316 | iron deficiency | 4 C0086132 | depressive symptoms | 3 C0037317 | sleep disturbance | 3 C0235169 | excitability | 2 C1963757 | dopamine dysregulation syndrome | 1 C0011570 | depression | 1 C0152025 | polyneuropathy | 1 |
Manually Genotype(Total Text Mining Genotypes:0) |
|---|
| (Waiting for update.) |
All Snps(Total Genotypes:31) | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| snpId | pubmedId | geneId | geneSymbol | diseaseId | sourceId | sentence | score | Year | geneSymbol_dbSNP | CHROMOSOME | POS | REF | ALT |
| rs1051308 | 26313808 | 3163 | HMOX2 | umls:C0035258 | BeFree | We analyzed whether HMOX1 and HMOX2 genes are related with the risk to develop RLS.We analyzed the distribution of genotypes and allelic frequencies of the HMOX1 rs2071746, HMOX1 rs2071747, HMOX2 rs2270363, and HMOX2 rs1051308 SNPs, as well as the presence of Copy number variations (CNVs) of these genes in 205 subjects RLS and 445 healthy controls.The frequencies of rs2071746TT genotype and rs2071746T allelic variant were significantly lower in RLS patients than that in controls, although the other 3 studied SNPs did not differ between RLS patients and controls. | 0.000271442 | 2015 | HMOX2;CDIP1 | 16 | 4510300 | G | A |
| rs12593813 | 17637780 | 5607 | MAP2K5 | umls:C0035258 | GWASCAT | In a genome-wide association study we found highly significant associations between RLS and intronic variants in the homeobox gene MEIS1, the BTBD9 gene encoding a BTB(POZ) domain as well as variants in a third locus containing the genes encoding mitogen-activated protein kinase MAP2K5 and the transcription factor LBXCOR1 on chromosomes 2p, 6p and 15q, respectively. | 0.132920927 | 2007 | MAP2K5 | 15 | 67744514 | A | G |
| rs12593813 | 21779176 | 5607 | MAP2K5 | umls:C0035258 | GWASCAT | Genome-wide association study identifies novel restless legs syndrome susceptibility loci on 2p14 and 16q12.1. | 0.132920927 | 2011 | MAP2K5 | 15 | 67744514 | A | G |
| rs12593813 | 21779176 | 5607 | MAP2K5 | umls:C0035258 | GAD | [Genome-wide association study identifies novel restless legs syndrome susceptibility loci on 2p14 and 16q12.1.] | 0.132920927 | 2011 | MAP2K5 | 15 | 67744514 | A | G |
| rs12593813 | 17637780 | 5607 | MAP2K5 | umls:C0035258 | GAD | [Genome-wide association study of restless legs syndrome identifies common variants in three genomic regions.] | 0.132920927 | 2007 | MAP2K5 | 15 | 67744514 | A | G |
| rs12593813 | 17637780 | 390598 | SKOR1 | umls:C0035258 | GAD | [Genome-wide association study of restless legs syndrome identifies common variants in three genomic regions.] | 0.00764398 | 2007 | MAP2K5 | 15 | 67744514 | A | G |
| rs1975197 | 21779176 | 5789 | PTPRD | umls:C0035258 | GAD | [Genome-wide association study identifies novel restless legs syndrome susceptibility loci on 2p14 and 16q12.1.] | 0.24827274 | 2011 | PTPRD | 9 | 8846955 | G | A |
| rs1975197 | 18660810 | 5789 | PTPRD | umls:C0035258 | GWASCAT | PTPRD (protein tyrosine phosphatase receptor type delta) is associated with restless legs syndrome. | 0.24827274 | 2008 | PTPRD | 9 | 8846955 | G | A |
| rs1975197 | 21779176 | 5789 | PTPRD | umls:C0035258 | GWASCAT | Genome-wide association study identifies novel restless legs syndrome susceptibility loci on 2p14 and 16q12.1. | 0.24827274 | 2011 | PTPRD | 9 | 8846955 | G | A |
| rs1975197 | 18660810 | 5789 | PTPRD | umls:C0035258 | GAD | [PTPRD (protein tyrosine phosphatase receptor type delta) is associated with restless legs syndrome.] | 0.24827274 | 2008 | PTPRD | 9 | 8846955 | G | A |
| rs2071746 | 26313808 | 3163 | HMOX2 | umls:C0035258 | BeFree | We analyzed whether HMOX1 and HMOX2 genes are related with the risk to develop RLS.We analyzed the distribution of genotypes and allelic frequencies of the HMOX1 rs2071746, HMOX1 rs2071747, HMOX2 rs2270363, and HMOX2 rs1051308 SNPs, as well as the presence of Copy number variations (CNVs) of these genes in 205 subjects RLS and 445 healthy controls.The frequencies of rs2071746TT genotype and rs2071746T allelic variant were significantly lower in RLS patients than that in controls, although the other 3 studied SNPs did not differ between RLS patients and controls. | 0.000271442 | 2015 | HMOX1 | 22 | 35380679 | A | T |
| rs2071747 | 26313808 | 3163 | HMOX2 | umls:C0035258 | BeFree | We analyzed whether HMOX1 and HMOX2 genes are related with the risk to develop RLS.We analyzed the distribution of genotypes and allelic frequencies of the HMOX1 rs2071746, HMOX1 rs2071747, HMOX2 rs2270363, and HMOX2 rs1051308 SNPs, as well as the presence of Copy number variations (CNVs) of these genes in 205 subjects RLS and 445 healthy controls.The frequencies of rs2071746TT genotype and rs2071746T allelic variant were significantly lower in RLS patients than that in controls, although the other 3 studied SNPs did not differ between RLS patients and controls. | 0.000271442 | 2015 | HMOX1 | 22 | 35381192 | G | C |
| rs2270363 | 26313808 | 3163 | HMOX2 | umls:C0035258 | BeFree | We analyzed whether HMOX1 and HMOX2 genes are related with the risk to develop RLS.We analyzed the distribution of genotypes and allelic frequencies of the HMOX1 rs2071746, HMOX1 rs2071747, HMOX2 rs2270363, and HMOX2 rs1051308 SNPs, as well as the presence of Copy number variations (CNVs) of these genes in 205 subjects RLS and 445 healthy controls.The frequencies of rs2071746TT genotype and rs2071746T allelic variant were significantly lower in RLS patients than that in controls, although the other 3 studied SNPs did not differ between RLS patients and controls. | 0.000271442 | 2015 | HMOX2;NMRAL1 | 16 | 4476291 | A | G |
| rs2300478 | 21779176 | 4211 | MEIS1 | umls:C0035258 | GAD | [Genome-wide association study identifies novel restless legs syndrome susceptibility loci on 2p14 and 16q12.1.] | 0.255559401 | 2011 | MEIS1 | 2 | 66554321 | T | G |
| rs2300478 | 17637780 | 4211 | MEIS1 | umls:C0035258 | GWASCAT | MEIS1 has been implicated in limb development, raising the possibility that RLS has components of a developmental disorder. | 0.255559401 | 2007 | MEIS1 | 2 | 66554321 | T | G |
| rs2300478 | 17637780 | 4211 | MEIS1 | umls:C0035258 | GAD | [Genome-wide association study of restless legs syndrome identifies common variants in three genomic regions.] | 0.255559401 | 2007 | MEIS1 | 2 | 66554321 | T | G |
| rs2300478 | 21779176 | 4211 | MEIS1 | umls:C0035258 | GWASCAT | Genome-wide association study identifies novel restless legs syndrome susceptibility loci on 2p14 and 16q12.1. | 0.255559401 | 2011 | MEIS1 | 2 | 66554321 | T | G |
| rs3104767 | 21779176 | 643714 | CASC16 | umls:C0035258 | GWASCAT | Genome-wide association study identifies novel restless legs syndrome susceptibility loci on 2p14 and 16q12.1. | 0.12 | 2011 | CASC16 | 16 | 52590826 | G | T |
| rs3104767 | 21779176 | 27324 | TOX3 | umls:C0035258 | GAD | [Genome-wide association study identifies novel restless legs syndrome susceptibility loci on 2p14 and 16q12.1.] | 0.002367032 | 2011 | CASC16 | 16 | 52590826 | G | T |
| rs3794087 | 24424098 | 6506 | SLC1A2 | umls:C0035258 | BeFree | The solute carrier family 1 (glial high affinity glutamate transporter), member 2 gene, SLC1A2, rs3794087 variant and assessment risk for restless legs syndrome. | 0.000271442 | 2013 | SLC1A2 | 11 | 35308068 | G | T |
| rs3923809 | 17634447 | 114781 | BTBD9 | umls:C0035258 | GWASCAT | In an Icelandic discovery sample of patients with RLS and periodic limb movements in sleep, we observed a genomewide significant association with a common variant in an intron of BTBD9 on chromosome 6p21.2 (odds ratio, 1.8; P=2x10(-9)). | 0.259098077 | 2007 | BTBD9;LOC101929425 | 6 | 38473194 | A | G |
| rs3923809 | 17634447 | 114781 | BTBD9 | umls:C0035258 | GAD | [We have discovered a variant associated with susceptibility to periodic limb movements in sleep. The inverse correlation of the variant with iron stores is consistent with the suspected involvement of iron depletion in the pathogenesis of the disease.] | 0.259098077 | 2007 | BTBD9;LOC101929425 | 6 | 38473194 | A | G |
| rs41305272 | 24436253 | 5607 | MAP2K5 | umls:C0035258 | BeFree | A predicted miR-330-3p target site SNP (rs41305272) in mitogen-activated protein kinase kinase 5 (MAP2K5) mRNA was in LD (d' = 1.0, r(2) = 0.02) with a reported GWAS-identified variant for restless legs syndrome (RLS), a disorder frequently comorbid with anxiety and depression, possibly because of a shared pathophysiology. | 0.132920927 | 2013 | MAP2K5 | 15 | 67807105 | C | T |
| rs41305272 | 24436253 | 442902 | MIR330 | umls:C0035258 | BeFree | A predicted miR-330-3p target site SNP (rs41305272) in mitogen-activated protein kinase kinase 5 (MAP2K5) mRNA was in LD (d' = 1.0, r(2) = 0.02) with a reported GWAS-identified variant for restless legs syndrome (RLS), a disorder frequently comorbid with anxiety and depression, possibly because of a shared pathophysiology. | 0.000271442 | 2013 | MAP2K5 | 15 | 67807105 | C | T |
| rs4626664 | 18660810 | 5789 | PTPRD | umls:C0035258 | GAD | [PTPRD (protein tyrosine phosphatase receptor type delta) is associated with restless legs syndrome.] | 0.24827274 | 2008 | PTPRD | 9 | 9261737 | G | A |
| rs4626664 | 18660810 | 5789 | PTPRD | umls:C0035258 | GWASCAT | PTPRD (protein tyrosine phosphatase receptor type delta) is associated with restless legs syndrome. | 0.24827274 | 2008 | PTPRD | 9 | 9261737 | G | A |
| rs6747972 | 21779176 | 54465 | ETAA1 | umls:C0035258 | GAD | [Genome-wide association study identifies novel restless legs syndrome susceptibility loci on 2p14 and 16q12.1.] | 0.002367032 | 2011 | NA | 2 | 67843093 | A | G |
| rs9296249 | 17637780 | 114781 | BTBD9 | umls:C0035258 | GAD | [Genome-wide association study of restless legs syndrome identifies common variants in three genomic regions.] | 0.259098077 | 2007 | BTBD9 | 6 | 38398065 | T | C |
| rs9296249 | 17637780 | 114781 | BTBD9 | umls:C0035258 | GWASCAT | In a genome-wide association study we found highly significant associations between RLS and intronic variants in the homeobox gene MEIS1, the BTBD9 gene encoding a BTB(POZ) domain as well as variants in a third locus containing the genes encoding mitogen-activated protein kinase MAP2K5 and the transcription factor LBXCOR1 on chromosomes 2p, 6p and 15q, respectively. | 0.259098077 | 2007 | BTBD9 | 6 | 38398065 | T | C |
| rs9357271 | 21779176 | 114781 | BTBD9 | umls:C0035258 | GWASCAT | Genome-wide association study identifies novel restless legs syndrome susceptibility loci on 2p14 and 16q12.1. | 0.259098077 | 2011 | BTBD9 | 6 | 38398097 | T | C |
| rs9357271 | 21779176 | 114781 | BTBD9 | umls:C0035258 | GAD | [Genome-wide association study identifies novel restless legs syndrome susceptibility loci on 2p14 and 16q12.1.] | 0.259098077 | 2011 | BTBD9 | 6 | 38398097 | T | C |
GWASdb Annotation(Total Genotypes:0) | |
|---|---|
| (Waiting for update.) | |
GWASdb Snp Trait(Total Genotypes:43) | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | 66764308 | rs12469063 | A | G | rs12469063 | 17637780 | 6.52E-12 | NA | NA | NA | 401 cases; 1,644 controls | NOPOP(2045) | ALL(2045) | NOPOP(2045) | ALL(2045) | Restless legs syndrome | HPOID:0002981 | Abnormality of the calf | DOID:0050425 | restless legs syndrome | D012148 | Restless Legs Syndrome | EFOID:0004270 | restless legs syndrome | Central nervous system disease | NA | Research Support, Non-U.S. Gov't | A | MEIS1 |
| 2 | 66781453 | rs2300478 | T | G | rs2300478 | 17637780 | 3.00E-28 | NA | 1.74 | [1.57-1.92] | 401 cases; 1,644 controls | NOPOP(2045) | ALL(2045) | NOPOP(2045) | ALL(2045) | Restless legs syndrome | HPOID:0002981 | Abnormality of the calf | DOID:0050425 | restless legs syndrome | D012148 | Restless Legs Syndrome | EFOID:0004270 | restless legs syndrome | Central nervous system disease | rs2300478-G | Research Support, Non-U.S. Gov't | T | MEIS1 |
| 2 | 66781453 | rs2300478 | T | G | rs2300478 | 21779176 | 3.00E-49 | NA | 1.68 | [1.57-1.81] | 922 European ancestry cases; 1,526 European ancestry controls | European(2448) | ALL(2448) | EUR(2448) | ALL(2448) | Restless legs syndrome | HPOID:0002981 | Abnormality of the calf | DOID:0050425 | restless legs syndrome | D012148 | Restless Legs Syndrome | EFOID:0004270 | restless legs syndrome | Central nervous system disease | rs2300478-G | Research Support, N.I.H., Extramural | Research Support, Non-U.S. Gov't | T |
| 2 | 68070225 | rs6747972 | A | G | rs6747972 | 21779176 | 9.00E-11 | NA | 1.23 | [1.16-1.31] | 922 European ancestry cases; 1,526 European ancestry controls | European(2448) | ALL(2448) | EUR(2448) | ALL(2448) | Restless legs syndrome | HPOID:0002981 | Abnormality of the calf | DOID:0050425 | restless legs syndrome | D012148 | Restless Legs Syndrome | EFOID:0004270 | restless legs syndrome | Central nervous system disease | rs6747972-A | Research Support, N.I.H., Extramural | Research Support, Non-U.S. Gov't | G |
| 6 | 38277910 | rs6905637 | C | T | rs6905637 | 17634447 | 2.00E-04 | NA | NA | NA | 306 cases; 15,664 controls | NOPOP(15970) | ALL(15970) | NOPOP(15970) | ALL(15970) | Restless legs syndrome | HPOID:0002981 | Abnormality of the calf | DOID:0050425 | restless legs syndrome | D012148 | Restless Legs Syndrome | EFOID:0004270 | restless legs syndrome | Central nervous system disease | NA | Research Support, Non-U.S. Gov't | T | BTBD9 |
| 6 | 38300140 | rs228181 | A | G | rs228181 | 17634447 | 8.00E-05 | NA | NA | NA | 306 cases; 15,664 controls | NOPOP(15970) | ALL(15970) | NOPOP(15970) | ALL(15970) | Restless legs syndrome | HPOID:0002981 | Abnormality of the calf | DOID:0050425 | restless legs syndrome | D012148 | Restless Legs Syndrome | EFOID:0004270 | restless legs syndrome | Central nervous system disease | NA | Research Support, Non-U.S. Gov't | A | BTBD9 |
| 6 | 38332610 | rs9394492 | C | T | rs9394492 | 17637780 | 4.07E-04 | NA | NA | NA | 401 cases; 1,644 controls | NOPOP(2045) | ALL(2045) | NOPOP(2045) | ALL(2045) | Restless legs syndrome | HPOID:0002981 | Abnormality of the calf | DOID:0050425 | restless legs syndrome | D012148 | Restless Legs Syndrome | EFOID:0004270 | restless legs syndrome | Central nervous system disease | NA | Research Support, Non-U.S. Gov't | T | BTBD9 |
| 6 | 38361112 | rs4714156 | C | T | rs4714156 | 17637780 | 6.50E-07 | NA | NA | NA | 401 cases; 1,644 controls | NOPOP(2045) | ALL(2045) | NOPOP(2045) | ALL(2045) | Restless legs syndrome | HPOID:0002981 | Abnormality of the calf | DOID:0050425 | restless legs syndrome | D012148 | Restless Legs Syndrome | EFOID:0004270 | restless legs syndrome | Central nervous system disease | NA | Research Support, Non-U.S. Gov't | C | BTBD9 |
| 6 | 38365841 | rs9296249 | T | C | rs9296249 | 17637780 | 4.00E-18 | NA | 1.67 | [1.49-1.89] | 401 cases; 1,644 controls | NOPOP(2045) | ALL(2045) | NOPOP(2045) | ALL(2045) | Restless legs syndrome | HPOID:0002981 | Abnormality of the calf | DOID:0050425 | restless legs syndrome | D012148 | Restless Legs Syndrome | EFOID:0004270 | restless legs syndrome | Central nervous system disease | rs9296249-T | Research Support, Non-U.S. Gov't | T | BTBD9 |
| 6 | 38365873 | rs9357271 | T | C | rs9357271 | 17634447 | 2.00E-07 | NA | NA | NA | 306 cases; 15,664 controls | NOPOP(15970) | ALL(15970) | NOPOP(15970) | ALL(15970) | Restless legs syndrome | HPOID:0002981 | Abnormality of the calf | DOID:0050425 | restless legs syndrome | D012148 | Restless Legs Syndrome | EFOID:0004270 | restless legs syndrome | Central nervous system disease | NA | Research Support, Non-U.S. Gov't | T | BTBD9 |
| 6 | 38365873 | rs9357271 | T | C | rs9357271 | 17637780 | 6.31E-18 | NA | NA | NA | 401 cases; 1,644 controls | NOPOP(2045) | ALL(2045) | NOPOP(2045) | ALL(2045) | Restless legs syndrome | HPOID:0002981 | Abnormality of the calf | DOID:0050425 | restless legs syndrome | D012148 | Restless Legs Syndrome | EFOID:0004270 | restless legs syndrome | Central nervous system disease | NA | Research Support, Non-U.S. Gov't | T | BTBD9 |
| 6 | 38365873 | rs9357271 | T | C | rs9357271 | 21779176 | 8.00E-22 | NA | 1.47 | [1.35-1.47] | 922 European ancestry cases; 1,526 European ancestry controls | European(2448) | ALL(2448) | EUR(2448) | ALL(2448) | Restless legs syndrome | HPOID:0002981 | Abnormality of the calf | DOID:0050425 | restless legs syndrome | D012148 | Restless Legs Syndrome | EFOID:0004270 | restless legs syndrome | Central nervous system disease | rs9357271-T | Research Support, N.I.H., Extramural | Research Support, Non-U.S. Gov't | T |
| 6 | 38366186 | rs4711546 | A | G | rs4711546 | 17634447 | 2.00E-06 | NA | NA | NA | 306 cases; 15,664 controls | NOPOP(15970) | ALL(15970) | NOPOP(15970) | ALL(15970) | Restless legs syndrome | HPOID:0002981 | Abnormality of the calf | DOID:0050425 | restless legs syndrome | D012148 | Restless Legs Syndrome | EFOID:0004270 | restless legs syndrome | Central nervous system disease | NA | Research Support, Non-U.S. Gov't | G | BTBD9 |
| 6 | 38400139 | rs4565302 | T | C | rs4565302 | 17634447 | 2.00E-04 | NA | NA | NA | 306 cases; 15,664 controls | NOPOP(15970) | ALL(15970) | NOPOP(15970) | ALL(15970) | Restless legs syndrome | HPOID:0002981 | Abnormality of the calf | DOID:0050425 | restless legs syndrome | D012148 | Restless Legs Syndrome | EFOID:0004270 | restless legs syndrome | Central nervous system disease | NA | Research Support, Non-U.S. Gov't | T | BTBD9 |
| 6 | 38408223 | rs12208647 | G | A | rs12208647 | 17634447 | 2.00E-04 | NA | NA | NA | 306 cases; 15,664 controls | NOPOP(15970) | ALL(15970) | NOPOP(15970) | ALL(15970) | Restless legs syndrome | HPOID:0002981 | Abnormality of the calf | DOID:0050425 | restless legs syndrome | D012148 | Restless Legs Syndrome | EFOID:0004270 | restless legs syndrome | Central nervous system disease | NA | Research Support, Non-U.S. Gov't | G | BTBD9 |
| 6 | 38436317 | rs6904723 | A | C | rs6904723 | 17634447 | 7.00E-07 | NA | NA | NA | 306 cases; 15,664 controls | NOPOP(15970) | ALL(15970) | NOPOP(15970) | ALL(15970) | Restless legs syndrome | HPOID:0002981 | Abnormality of the calf | DOID:0050425 | restless legs syndrome | D012148 | Restless Legs Syndrome | EFOID:0004270 | restless legs syndrome | Central nervous system disease | NA | Research Support, Non-U.S. Gov't | C | BTBD9 |
| 6 | 38440970 | rs3923809 | A | G | rs3923809 | 17634447 | 1.00E-17 | NA | 1.9 | [1.50-2.20] | 306 cases; 15,664 controls | NOPOP(15970) | ALL(15970) | NOPOP(15970) | ALL(15970) | Restless legs syndrome | HPOID:0002981 | Abnormality of the calf | DOID:0050425 | restless legs syndrome | D012148 | Restless Legs Syndrome | EFOID:0004270 | restless legs syndrome | Central nervous system disease | rs3923809-A | Research Support, Non-U.S. Gov't | G | BTBD9 |
| 6 | 38440970 | rs3923809 | A | G | rs3923809 | 17637780 | 1.75E-09 | NA | NA | NA | 401 cases; 1,644 controls | NOPOP(2045) | ALL(2045) | NOPOP(2045) | ALL(2045) | Restless legs syndrome | HPOID:0002981 | Abnormality of the calf | DOID:0050425 | restless legs syndrome | D012148 | Restless Legs Syndrome | EFOID:0004270 | restless legs syndrome | Central nervous system disease | NA | Research Support, Non-U.S. Gov't | G | BTBD9 |
| 6 | 38470087 | rs4236060 | C | T | rs4236060 | 17637780 | 1.00E-08 | NA | NA | NA | 401 cases; 1,644 controls | NOPOP(2045) | ALL(2045) | NOPOP(2045) | ALL(2045) | Restless legs syndrome | HPOID:0002981 | Abnormality of the calf | DOID:0050425 | restless legs syndrome | D012148 | Restless Legs Syndrome | EFOID:0004270 | restless legs syndrome | Central nervous system disease | NA | Research Support, Non-U.S. Gov't | C | BTBD9 |
| 6 | 38483564 | rs6923737 | T | C | rs6923737 | 17634447 | 1.00E-07 | NA | NA | NA | 306 cases; 15,664 controls | NOPOP(15970) | ALL(15970) | NOPOP(15970) | ALL(15970) | Restless legs syndrome | HPOID:0002981 | Abnormality of the calf | DOID:0050425 | restless legs syndrome | D012148 | Restless Legs Syndrome | EFOID:0004270 | restless legs syndrome | Central nervous system disease | NA | Research Support, Non-U.S. Gov't | T | BTBD9 |
| 6 | 38535576 | rs1321056 | G | A | rs1321056 | 17634447 | 4.00E-05 | NA | NA | NA | 306 cases; 15,664 controls | NOPOP(15970) | ALL(15970) | NOPOP(15970) | ALL(15970) | Restless legs syndrome | HPOID:0002981 | Abnormality of the calf | DOID:0050425 | restless legs syndrome | D012148 | Restless Legs Syndrome | EFOID:0004270 | restless legs syndrome | Central nervous system disease | NA | Research Support, Non-U.S. Gov't | T | BTBD9 |
| 6 | 38543377 | rs17543178 | A | G | rs17543178 | 17634447 | 3.00E-04 | NA | NA | NA | 306 cases; 15,664 controls | NOPOP(15970) | ALL(15970) | NOPOP(15970) | ALL(15970) | Restless legs syndrome | HPOID:0002981 | Abnormality of the calf | DOID:0050425 | restless legs syndrome | D012148 | Restless Legs Syndrome | EFOID:0004270 | restless legs syndrome | Central nervous system disease | NA | Research Support, Non-U.S. Gov't | A | BTBD9 |
| 6 | 38544497 | rs2814894 | A | G | rs2814894 | 17634447 | 3.00E-05 | NA | NA | NA | 306 cases; 15,664 controls | NOPOP(15970) | ALL(15970) | NOPOP(15970) | ALL(15970) | Restless legs syndrome | HPOID:0002981 | Abnormality of the calf | DOID:0050425 | restless legs syndrome | D012148 | Restless Legs Syndrome | EFOID:0004270 | restless legs syndrome | Central nervous system disease | NA | Research Support, Non-U.S. Gov't | G | BTBD9 |
| 6 | 38599566 | rs1739626 | C | A | rs1739626 | 17634447 | 5.00E-05 | NA | NA | NA | 306 cases; 15,664 controls | NOPOP(15970) | ALL(15970) | NOPOP(15970) | ALL(15970) | Restless legs syndrome | HPOID:0002981 | Abnormality of the calf | DOID:0050425 | restless legs syndrome | D012148 | Restless Legs Syndrome | EFOID:0004270 | restless legs syndrome | Central nervous system disease | NA | Research Support, Non-U.S. Gov't | T | BTBD9 |
| 6 | 38627279 | rs1781738 | T | C | rs1781738 | 17634447 | 6.00E-05 | NA | NA | NA | 306 cases; 15,664 controls | NOPOP(15970) | ALL(15970) | NOPOP(15970) | ALL(15970) | Restless legs syndrome | HPOID:0002981 | Abnormality of the calf | DOID:0050425 | restless legs syndrome | D012148 | Restless Legs Syndrome | EFOID:0004270 | restless legs syndrome | Central nervous system disease | NA | Research Support, Non-U.S. Gov't | G | NA |
| 9 | 8846955 | rs1975197 | G | A | rs1975197 | 18660810 | 6.00E-09 | 1.31 | [1.20-1.44] | 628 cases; 1,644 controls | NOPOP(2272) | ALL(2272) | NOPOP(2272) | ALL(2272) | Restless legs syndrome | HPOID:0002981 | Abnormality of the calf | DOID:0050425 | restless legs syndrome | D012148 | Restless Legs Syndrome | EFOID:0004270 | restless legs syndrome | Central nervous system disease | rs1975197-T | Research Support, Non-U.S. Gov't | C | PTPRD | |
| 9 | 8846955 | rs1975197 | G | A | rs1975197 | 21779176 | 3.00E-10 | NA | 1.29 | [1.19-1.40] | 922 European ancestry cases; 1,526 European ancestry controls | European(2448) | ALL(2448) | EUR(2448) | ALL(2448) | Restless legs syndrome | HPOID:0002981 | Abnormality of the calf | DOID:0050425 | restless legs syndrome | D012148 | Restless Legs Syndrome | EFOID:0004270 | restless legs syndrome | Central nervous system disease | rs1975197-A | Research Support, N.I.H., Extramural | Research Support, Non-U.S. Gov't | C |
| 9 | 9261737 | rs35041767 | G | GC | rs4626664 | 17637780 | 6.81E-06 | NA | NA | NA | 401 cases; 1,644 controls | NOPOP(2045) | ALL(2045) | NOPOP(2045) | ALL(2045) | Restless legs syndrome | HPOID:0002981 | Abnormality of the calf | DOID:0050425 | restless legs syndrome | D012148 | Restless Legs Syndrome | EFOID:0004270 | restless legs syndrome | Central nervous system disease | NA | Research Support, Non-U.S. Gov't | G | PTPRD |
| 9 | 9261737 | rs35041767 | G | GC | rs4626664 | 18660810 | 6.00E-10 | NA | 1.44 | [1.31-1.59] | 628 cases; 1,644 controls | NOPOP(2272) | ALL(2272) | NOPOP(2272) | ALL(2272) | Restless legs syndrome | HPOID:0002981 | Abnormality of the calf | DOID:0050425 | restless legs syndrome | D012148 | Restless Legs Syndrome | EFOID:0004270 | restless legs syndrome | Central nervous system disease | rs4626664-A | Research Support, Non-U.S. Gov't | G | PTPRD |
| 9 | 9261737 | rs4626664 | G | A | rs4626664 | 17637780 | 6.81E-06 | NA | NA | NA | 401 cases; 1,644 controls | NOPOP(2045) | ALL(2045) | NOPOP(2045) | ALL(2045) | Restless legs syndrome | HPOID:0002981 | Abnormality of the calf | DOID:0050425 | restless legs syndrome | D012148 | Restless Legs Syndrome | EFOID:0004270 | restless legs syndrome | Central nervous system disease | NA | Research Support, Non-U.S. Gov't | G | PTPRD |
| 9 | 9261737 | rs4626664 | G | A | rs4626664 | 18660810 | 6.00E-10 | NA | 1.44 | [1.31-1.59] | 628 cases; 1,644 controls | NOPOP(2272) | ALL(2272) | NOPOP(2272) | ALL(2272) | Restless legs syndrome | HPOID:0002981 | Abnormality of the calf | DOID:0050425 | restless legs syndrome | D012148 | Restless Legs Syndrome | EFOID:0004270 | restless legs syndrome | Central nervous system disease | rs4626664-A | Research Support, Non-U.S. Gov't | G | PTPRD |
| 15 | 68036852 | rs12593813 | A | G | rs12593813 | 17637780 | 1.00E-15 | NA | 1.5 | [1.36-1.66] | 401 cases; 1,644 controls | NOPOP(2045) | ALL(2045) | NOPOP(2045) | ALL(2045) | Restless legs syndrome | HPOID:0002981 | Abnormality of the calf | DOID:0050425 | restless legs syndrome | D012148 | Restless Legs Syndrome | EFOID:0004270 | restless legs syndrome | Central nervous system disease | rs12593813-G | Research Support, Non-U.S. Gov't | A | MAP2K5 |
| 15 | 68036852 | rs12593813 | A | G | rs12593813 | 21779176 | 1.00E-22 | NA | 1.41 | [1.32-1.52] | 922 European ancestry cases; 1,526 European ancestry controls | European(2448) | ALL(2448) | EUR(2448) | ALL(2448) | Restless legs syndrome | HPOID:0002981 | Abnormality of the calf | DOID:0050425 | restless legs syndrome | D012148 | Restless Legs Syndrome | EFOID:0004270 | restless legs syndrome | Central nervous system disease | rs12593813-G | Research Support, N.I.H., Extramural | Research Support, Non-U.S. Gov't | A |
| 15 | 68037578 | rs11635424 | A | G | rs11635424 | 17637780 | 3.65E-16 | NA | NA | NA | 401 cases; 1,644 controls | NOPOP(2045) | ALL(2045) | NOPOP(2045) | ALL(2045) | Restless legs syndrome | HPOID:0002981 | Abnormality of the calf | DOID:0050425 | restless legs syndrome | D012148 | Restless Legs Syndrome | EFOID:0004270 | restless legs syndrome | Central nervous system disease | NA | Research Support, Non-U.S. Gov't | A | MAP2K5 |
| 15 | 68054388 | rs884202 | G | A | rs884202 | 17637780 | 1.17E-05 | NA | NA | NA | 401 cases; 1,644 controls | NOPOP(2045) | ALL(2045) | NOPOP(2045) | ALL(2045) | Restless legs syndrome | HPOID:0002981 | Abnormality of the calf | DOID:0050425 | restless legs syndrome | D012148 | Restless Legs Syndrome | EFOID:0004270 | restless legs syndrome | Central nervous system disease | NA | Research Support, Non-U.S. Gov't | G | MAP2K5 |
| 15 | 68072075 | rs4489954 | T | G | rs4489954 | 17637780 | 2.68E-15 | NA | NA | NA | 401 cases; 1,644 controls | NOPOP(2045) | ALL(2045) | NOPOP(2045) | ALL(2045) | Restless legs syndrome | HPOID:0002981 | Abnormality of the calf | DOID:0050425 | restless legs syndrome | D012148 | Restless Legs Syndrome | EFOID:0004270 | restless legs syndrome | Central nervous system disease | NA | Research Support, Non-U.S. Gov't | T | MAP2K5 |
| 15 | 68072275 | rs3784709 | C | T | rs3784709 | 17637780 | 4.06E-16 | NA | NA | NA | 401 cases; 1,644 controls | NOPOP(2045) | ALL(2045) | NOPOP(2045) | ALL(2045) | Restless legs syndrome | HPOID:0002981 | Abnormality of the calf | DOID:0050425 | restless legs syndrome | D012148 | Restless Legs Syndrome | EFOID:0004270 | restless legs syndrome | Central nervous system disease | NA | Research Support, Non-U.S. Gov't | T | MAP2K5 |
| 15 | 68095085 | rs1026732 | G | A | rs1026732 | 17637780 | 6.09E-17 | NA | NA | NA | 401 cases; 1,644 controls | NOPOP(2045) | ALL(2045) | NOPOP(2045) | ALL(2045) | Restless legs syndrome | HPOID:0002981 | Abnormality of the calf | DOID:0050425 | restless legs syndrome | D012148 | Restless Legs Syndrome | EFOID:0004270 | restless legs syndrome | Central nervous system disease | NA | Research Support, Non-U.S. Gov't | A | MAP2K5 |
| 15 | 68103206 | rs6494696 | G | C | rs6494696 | 17637780 | 2.00E-16 | NA | NA | NA | 401 cases; 1,644 controls | NOPOP(2045) | ALL(2045) | NOPOP(2045) | ALL(2045) | Restless legs syndrome | HPOID:0002981 | Abnormality of the calf | DOID:0050425 | restless legs syndrome | D012148 | Restless Legs Syndrome | EFOID:0004270 | restless legs syndrome | Central nervous system disease | NA | Research Support, Non-U.S. Gov't | C | NA |
| 16 | 7467489 | rs6500963 | T | C | rs6500963 | 17637780 | 2.69E-06 | NA | NA | NA | 401 cases; 1,644 controls | NOPOP(2045) | ALL(2045) | NOPOP(2045) | ALL(2045) | Restless legs syndrome | HPOID:0002981 | Abnormality of the calf | DOID:0050425 | restless legs syndrome | D012148 | Restless Legs Syndrome | EFOID:0004270 | restless legs syndrome | Central nervous system disease | NA | Research Support, Non-U.S. Gov't | C | RBFOX1 |
| 16 | 52624738 | rs3104767 | G | T | rs3104767 | 21779176 | 9.00E-19 | NA | 1.35 | [1.27-1.43] | 922 European ancestry cases; 1,526 European ancestry controls | European(2448) | ALL(2448) | EUR(2448) | ALL(2448) | Restless legs syndrome | HPOID:0002981 | Abnormality of the calf | DOID:0050425 | restless legs syndrome | D012148 | Restless Legs Syndrome | EFOID:0004270 | restless legs syndrome | Central nervous system disease | rs3104767-G | Research Support, N.I.H., Extramural | Research Support, Non-U.S. Gov't | T |
| X | 42848384 | rs1983167 | T | C | rs1983167 | 17637780 | 6.48E-07 | NA | NA | NA | 401 cases; 1,644 controls | NOPOP(2045) | ALL(2045) | NOPOP(2045) | ALL(2045) | Restless legs syndrome | HPOID:0002981 | Abnormality of the calf | DOID:0050425 | restless legs syndrome | D012148 | Restless Legs Syndrome | EFOID:0004270 | restless legs syndrome | Central nervous system disease | NA | Research Support, Non-U.S. Gov't | G | NA |
| X | 42854606 | rs7881785 | A | G | rs7881785 | 17637780 | 9.01E-07 | NA | NA | NA | 401 cases; 1,644 controls | NOPOP(2045) | ALL(2045) | NOPOP(2045) | ALL(2045) | Restless legs syndrome | HPOID:0002981 | Abnormality of the calf | DOID:0050425 | restless legs syndrome | D012148 | Restless Legs Syndrome | EFOID:0004270 | restless legs syndrome | Central nervous system disease | NA | Research Support, Non-U.S. Gov't | G | NA |
Mapped by lexical matching(Total Items:0) |
|---|
| (Waiting for update.) |
Mapped by homologous gene(Total Items:0) |
|---|
| (Waiting for update.) |
Chemical(Total Drugs:18) | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| CUI | ChemicalName | ChemicalID | CasRN | DiseaseName | DiseaseID | DirectEvidence | PubMedIDs | ||
| C0035258 | cabergoline | C047047 | 81409-90-7 | restless legs syndrome | MESH:D012148 | therapeutic | 17230484 | ||
| C0035258 | caffeine | D002110 | 1958/8/2 | restless legs syndrome | MESH:D012148 | marker/mechanism | 690085 | ||
| C0035258 | citalopram | D015283 | 59729-33-8 | restless legs syndrome | MESH:D012148 | marker/mechanism | 17189751 | ||
| C0035258 | clozapine | D003024 | 5786-21-0 | restless legs syndrome | MESH:D012148 | marker/mechanism | 17224721 | ||
| C0035258 | fluoxetine | D005473 | 54910-89-3 | restless legs syndrome | MESH:D012148 | marker/mechanism | 18468624 | ||
| C0035258 | gabapentin | C040029 | 60142-96-3 | restless legs syndrome | MESH:D012148 | therapeutic | 18656214 | ||
| C0035258 | dextromethorphan | D003915 | 125-71-3 | restless legs syndrome | MESH:D012148 | therapeutic | 10985875 | ||
| C0035258 | mirtazapine | C035133 | - | restless legs syndrome | MESH:D012148 | marker/mechanism | 12530413 | ||
| C0035258 | olanzapine | C076029 | 132539-06-1 | restless legs syndrome | MESH:D012148 | marker/mechanism | 10505594 | ||
| C0035258 | oxycodone | D010098 | 76-42-6 | restless legs syndrome | MESH:D012148 | therapeutic | 18656214 | ||
| C0035258 | pramipexole | C061333 | - | restless legs syndrome | MESH:D012148 | therapeutic | 10553755 | ||
| C0035258 | pregabalin | D000069583 | - | restless legs syndrome | MESH:D012148 | marker/mechanism | 20140131 | ||
| C0035258 | pregabalin | D000069583 | - | restless legs syndrome | MESH:D012148 | therapeutic | 18656214 | ||
| C0035258 | propranolol | D011433 | 525-66-6 | restless legs syndrome | MESH:D012148 | therapeutic | 3717447 | ||
| C0035258 | ropinirole | C046649 | 91374-21-9 | restless legs syndrome | MESH:D012148 | therapeutic | 18656214 | ||
| C0035258 | topiramate | C052342 | 97240-79-4 | restless legs syndrome | MESH:D012148 | marker/mechanism | 19444538 | ||
| C0035258 | tramadol | D014147 | 27203-92-5 | restless legs syndrome | MESH:D012148 | marker/mechanism | 17230457 | ||
| C0035258 | tramadol | D014147 | 27203-92-5 | restless legs syndrome | MESH:D012148 | therapeutic | 18656214 | ||
FDA approved drug and dosage information(Total Drugs:26) | ||||||||
|---|---|---|---|---|---|---|---|---|
| DiseaseID | Drug_name | active_ingredients | strength | Dosage Form/Route | Marketing Status | TE code | RLD | RS |
| MESH:D012148 | neurontin | gabapentin | 100MG | CAPSULE;ORAL | Prescription | AB | Yes | No |
| MESH:D012148 | neurontin | gabapentin | 600MG | TABLET;ORAL | Prescription | AB | Yes | No |
| MESH:D012148 | neurontin | gabapentin | 250MG/5ML | SOLUTION;ORAL | Prescription | AA | Yes | Yes |
| MESH:D012148 | neurontin | gabapentin | 0 | SOLUTION; ORAL | Prescription | None | No | No |
| MESH:D012148 | neurontin | gabapentin | 600MG | TABLET; ORAL | Prescription | None | No | No |
| MESH:D012148 | neurontin | gabapentin | 800MG | CAPSULE; ORAL | Prescription | None | No | No |
| MESH:D012148 | neurontin | gabapentin | 250MG/5ML | SOLUTION; ORAL | Prescription | None | No | No |
| MESH:D012148 | remeron | mirtazapine | 15MG | TABLET;ORAL | Prescription | AB | Yes | Yes |
| MESH:D012148 | zyprexa | olanzapine | 2.5MG | TABLET;ORAL | Prescription | AB | Yes | No |
| MESH:D012148 | zyprexa | olanzapine | 10MG/VIAL | INJECTABLE;INTRAMUSCULAR | Prescription | AP | Yes | Yes |
| MESH:D012148 | zyprexa | olanzapine | 2.5MG | TABLET;ORAL | Prescription | AB | Yes | No |
| MESH:D012148 | zyprexa | olanzapine | 10MG/VIAL | INJECTABLE;INTRAMUSCULAR | Prescription | AP | Yes | Yes |
| MESH:D012148 | topamax | topiramate | 100MG | TABLET;ORAL | Prescription | AB | Yes | Yes |
| MESH:D012148 | topamax | topiramate | 15MG | CAPSULE;ORAL | Prescription | AB | Yes | No |
| MESH:D012148 | topamax | topiramate | 100MG | TABLET;ORAL | Prescription | AB | Yes | Yes |
| MESH:D012148 | topamax | topiramate | 15MG | CAPSULE;ORAL | Prescription | AB | Yes | No |
| MESH:D012148 | topamax | topiramate | 100MG | TABLET;ORAL | Prescription | AB | Yes | Yes |
| MESH:D012148 | topamax | topiramate | 15MG | CAPSULE;ORAL | Prescription | AB | Yes | No |
| MESH:D012148 | topamax | topiramate | 100MG | TABLET;ORAL | Prescription | AB | Yes | Yes |
| MESH:D012148 | topamax | topiramate | 15MG | CAPSULE;ORAL | Prescription | AB | Yes | No |
| MESH:D012148 | lyrica | pregabalin | 25MG | CAPSULE;ORAL | Prescription | None | Yes | No |
| MESH:D012148 | lyrica | pregabalin | 25MG | CAPSULE;ORAL | Prescription | None | Yes | No |
| MESH:D012148 | lyrica | pregabalin | 25MG | CAPSULE; ORAL | Prescription | None | No | No |
| MESH:D012148 | lyrica | pregabalin | 25MG | CAPSULE; ORAL | Prescription | None | No | No |
| MESH:D012148 | lyrica | pregabalin | 25MG | CAPSULE; ORAL | Prescription | None | No | No |
| MESH:D012148 | lyrica | pregabalin | 25MG | CAPSULE; ORAL | Prescription | None | No | No |
FDA labeling changes(Total Drugs:26) | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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:D012148 | 12/10/2000 | neurontin | gabapentin | Adjunctive therapy in the treatment of partial seizures | Safety and effectiveness established down to 3 years Neuropsychiatric AE's identified in 3-12 year olds Oral clearance normalized per body weight increased in children | Labeling | B | - | - | - | Parke-Davis | 2/2/2000 | FALSE' |
| MESH:D012148 | 12/10/2000 | neurontin | gabapentin | Adjunctive therapy in the treatment of partial seizures | Safety and effectiveness established down to 3 years Neuropsychiatric AE's identified in 3-12 year olds Oral clearance normalized per body weight increased in children | Labeling | B | - | - | - | Parke-Davis | 2/2/2000 | FALSE' |
| MESH:D012148 | 12/10/2000 | neurontin | gabapentin | Adjunctive therapy in the treatment of partial seizures | Safety and effectiveness established down to 3 years Neuropsychiatric AE's identified in 3-12 year olds Oral clearance normalized per body weight increased in children | Labeling | B | - | - | - | Parke-Davis | 2/2/2000 | FALSE' |
| MESH:D012148 | 12/10/2000 | neurontin | gabapentin | Adjunctive therapy in the treatment of partial seizures | Safety and effectiveness established down to 3 years Neuropsychiatric AE's identified in 3-12 year olds Oral clearance normalized per body weight increased in children | Labeling | B | - | - | - | Parke-Davis | 2/2/2000 | FALSE' |
| MESH:D012148 | 12/10/2000 | neurontin | gabapentin | Adjunctive therapy in the treatment of partial seizures | Safety and effectiveness established down to 3 years Neuropsychiatric AE's identified in 3-12 year olds Oral clearance normalized per body weight increased in children | Labeling | B | - | - | - | Parke-Davis | 2/2/2000 | FALSE' |
| MESH:D012148 | 12/10/2000 | neurontin | gabapentin | Adjunctive therapy in the treatment of partial seizures | Safety and effectiveness established down to 3 years Neuropsychiatric AE's identified in 3-12 year olds Oral clearance normalized per body weight increased in children | Labeling | B | - | - | - | Parke-Davis | 2/2/2000 | FALSE' |
| MESH:D012148 | 12/10/2000 | neurontin | gabapentin | Adjunctive therapy in the treatment of partial seizures | Safety and effectiveness established down to 3 years Neuropsychiatric AE's identified in 3-12 year olds Oral clearance normalized per body weight increased in children | Labeling | B | - | - | - | Parke-Davis | 2/2/2000 | FALSE' |
| MESH:D012148 | 12/1/2005 | remeron | mirtazapine | Major Depressive Disorder | Safety and effectiveness in the pediatric population have not been established FDA required boxed warning for all antidepressants: Suicidality in Children and Adolescents - Antidepressants increased the risk of suicidal thinking and behavior (suicidality) in short-term studies in children and adolescents with Major Depressive Disorder (MDD) and other psychiatric disorders. Anyone considering the use of Remeron or any other antidepressant in a child or adolescent must balance this risk with the clinical need. Patients who are started on therapy should be observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Remeron is not approved for use in pediatric patients. (See Warnings and Precautions: Pediatric Use) Pooled analyses of short-term (4 to 16 weeks) placebo-controlled trials of 9 antidepressant drugs (SSRIs and others) in children and adolescents with major depressive disorder (MDD), obsessive compulsive disorder (OCD), or other psychiatric disorders (a total of 24 trials involving over 4400 patients) have revealed a greater risk of adverse events representing suicidal thinking or behavior (suicidality) during the first few months of treatment in those receiving antidepressants. The average risk of such events in patients receiving antidepressants was 4%, twice the placebo risk of 2%. No suicides occurred in these trials Two placebo-controlled trials in 258 pediatric patients with MDD have been conducted with Remeron and the data were not sufficient to support a claim for use in pediatric patients | Labeling | B | - | - | - | Organon | - | FALSE' |
| MESH:D012148 | 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:D012148 | 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:D012148 | 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:D012148 | 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:D012148 | 12/22/2009 | topamax | topiramate | Migraine Prophylaxis | Safety and effectiveness for migraine prevention in pediatric patients have not been established Dose-related increased shift in serum creatinine in adolescent patients occurred in a clinical study Information added to Warnings and Precautions and Pediatric Use | Labeling | - | P | - | - | Ortho-McNeil-Janssen | - | FALSE' |
| MESH:D012148 | 12/22/2009 | topamax | topiramate | Migraine Prophylaxis | Safety and effectiveness for migraine prevention in pediatric patients have not been established Dose-related increased shift in serum creatinine in adolescent patients occurred in a clinical study Information added to Warnings and Precautions and Pediatric Use | Labeling | - | P | - | - | Ortho-McNeil-Janssen | - | FALSE' |
| MESH:D012148 | 12/22/2009 | topamax | topiramate | Adjunctive Treatment for Partial Onset Epilepsy in Infants and Toddlers 1 to 24 months | Effectiveness was not demonstrated as adjunctive therapy in a randomized, double-blind trial in infants/toddlers 1 to 24 months of age with refractory partial onset seizures Trials in infants/toddlers 1 to 24 months suggested some adverse reactions/toxicities not previously observed in older pediatric patients and adults; i.e, growth/length retardation, certain clinical laboratory abnormalities, and other adverse reactions/toxicities that occurred with a greater frequency and/or greater severity than had been recognized previously from studies in older pediatric patients or adults for various indications. Information added to Warnings and Precautions and Pediatric Use | Labeling | B | - | - | - | Ortho-McNeil-Janssen | 07/24/2008 | FALSE' |
| MESH:D012148 | 12/22/2009 | topamax | topiramate | Adjunctive Treatment for Partial Onset Epilepsy in Infants and Toddlers 1 to 24 months | Effectiveness was not demonstrated as adjunctive therapy in a randomized, double-blind trial in infants/toddlers 1 to 24 months of age with refractory partial onset seizures Trials in infants/toddlers 1 to 24 months suggested some adverse reactions/toxicities not previously observed in older pediatric patients and adults; i.e, growth/length retardation, certain clinical laboratory abnormalities, and other adverse reactions/toxicities that occurred with a greater frequency and/or greater severity than had been recognized previously from studies in older pediatric patients or adults for various indications. Information added to Warnings and Precautions and Pediatric Use | Labeling | B | - | - | - | Ortho-McNeil-Janssen | 07/24/2008 | FALSE' |
| MESH:D012148 | 07/15/2011 | topamax | topiramate | Monotherapy for partial onset or primary generalized tonic-clonic seizures | Expanded age range down to 2 years; previously approved for monotherapy for partial onset or primary generalized tonic-clonic seizures in patients10 years and older Information on weight based dosing in 2 to < 10 yearsPostmarketing study | Labeling | - | P | - | - | Janssen | - | FALSE' |
| MESH:D012148 | 07/15/2011 | topamax | topiramate | Monotherapy for partial onset or primary generalized tonic-clonic seizures | Expanded age range down to 2 years; previously approved for monotherapy for partial onset or primary generalized tonic-clonic seizures in patients10 years and older Information on weight based dosing in 2 to < 10 yearsPostmarketing study | Labeling | - | P | - | - | Janssen | - | FALSE' |
| MESH:D012148 | 03/28/2014 | topamax | topiramate | Prophylaxis of migraine headache | Approved for use in pediatric patients 12 years and older Safety and effectiveness in pediatric patients less than12 years have not been established for the prophylaxis treatment of migraine headache In the adolescent migraine trials (12 to 17 years), the most commonly observed adverse reactions were: paresthesia, upper respiratory tract infection, anorexia, and abdominal pain The most common cognitive adverse reaction in pooled double-blind studies in adolescent patients 12 to 17 years was difficulty with concentration/attention Markedly abnormally low serum bicarbonate values indicative of metabolic acidosis were reported in topiramate-treated adolescent migraine patients In topiramate-treated patients 12 to 17 years compared to placebo-treated patients, abnormally increased results were more frequent for creatinine, BUN, uric acid, chloride, ammonia, total protein, and platelets. Abnormally decreased results were observed with topiramate vs placebo treatment for phosphorus and bicarbonate Notable changes (increases and decreases) from baseline in systolic blood pressure, diastolic blood pressure, and pulse were observed more commonly in adolescents treated with topiramate compared to adolescents treated with placebo Information on dosing, adverse reactions, laboratory abnormalities, and clinical trials Postmarketing study | Labeling | - | P | - | - | Janssen | - | FALSE' |
| MESH:D012148 | 03/28/2014 | topamax | topiramate | Prophylaxis of migraine headache | Approved for use in pediatric patients 12 years and older Safety and effectiveness in pediatric patients less than12 years have not been established for the prophylaxis treatment of migraine headache In the adolescent migraine trials (12 to 17 years), the most commonly observed adverse reactions were: paresthesia, upper respiratory tract infection, anorexia, and abdominal pain The most common cognitive adverse reaction in pooled double-blind studies in adolescent patients 12 to 17 years was difficulty with concentration/attention Markedly abnormally low serum bicarbonate values indicative of metabolic acidosis were reported in topiramate-treated adolescent migraine patients In topiramate-treated patients 12 to 17 years compared to placebo-treated patients, abnormally increased results were more frequent for creatinine, BUN, uric acid, chloride, ammonia, total protein, and platelets. Abnormally decreased results were observed with topiramate vs placebo treatment for phosphorus and bicarbonate Notable changes (increases and decreases) from baseline in systolic blood pressure, diastolic blood pressure, and pulse were observed more commonly in adolescents treated with topiramate compared to adolescents treated with placebo Information on dosing, adverse reactions, laboratory abnormalities, and clinical trials Postmarketing study | Labeling | - | P | - | - | Janssen | - | FALSE' |
| MESH:D012148 | 12/22/2016 | lyrica | pregabalin | Fibromyalgia | Safety 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:D012148 | 12/22/2016 | lyrica | pregabalin | Fibromyalgia | Safety 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:D012148 | 12/22/2016 | lyrica | pregabalin | Fibromyalgia | Safety 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:D012148 | 12/22/2016 | lyrica | pregabalin | Fibromyalgia | Safety 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:D012148 | 12/22/2016 | lyrica | pregabalin | Fibromyalgia | Safety 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:D012148 | 12/22/2016 | lyrica | pregabalin | Fibromyalgia | Safety 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 |