PedAM
Pediatric Disease Annotations & Medicines
| dyspepsia | ||||
| Disease ID | 887 |
|---|---|
| Disease | dyspepsia |
| Manually Symptom | (Waiting for update.) |
| Text Mined Symptom | UMLS | Name | Sentences' Count(Total Symptoms:12) C0009450 | infection | 21 C0426576 | gastrointestinal symptoms | 9 C0850666 | h. pylori infection | 7 C0017152 | gastritis | 4 C0232493 | epigastric pain | 4 C0022104 | irritable bowel syndrome | 3 C0850666 | helicobacter pylori infection | 3 C0030286 | pancreatic disease | 2 C0011389 | dental plaque | 1 C0024623 | gastric cancer | 1 C0030920 | peptic ulcer | 1 C0017168 | acid reflux | 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 |
| rs11536889 | 23565226 | 7097 | TLR2 | umls:C0013395 | BeFree | A case-control study comprising 284 ethnic Chinese individuals (70 non-cardia GC cases and 214 functional dyspepsia controls) was conducted for the genotyping of TLR2 -196 to -174del, CD14 -260 C/T and TLR4 rs11536889 using PCR, RT-PCR and mass spectrometry. | 0.000271442 | 2013 | TLR4 | 9 | 117715853 | G | C |
| rs2015062 | 19147801 | 4512 | COX1 | umls:C0013395 | GAD | [Mitochondrial DNA and gastrointestinal motor and sensory functions in health and functional gastrointestinal disorders.] | 0.002367032 | 2009 | COX1 | MT | 7028 | C | T |
| rs3928306 | 19147801 | 4550 | RNR2 | umls:C0013395 | GAD | [Mitochondrial DNA and gastrointestinal motor and sensory functions in health and functional gastrointestinal disorders.] | 0.002367032 | 2009 | NA | MT | 3010 | G | A |
| rs5443 | 21443717 | 2784 | GNB3 | umls:C0013395 | BeFree | On the other hand, the association between T allele of GNB3 C825T polymorphism and dyspepsia was reported from Japan and Netherlands. | 0.013549688 | 2011 | GNB3;CDCA3 | 12 | 6845711 | C | T |
GWASdb Annotation(Total Genotypes:0) | |
|---|---|
| (Waiting for update.) | |
GWASdb Snp Trait(Total Genotypes:0) | |
|---|---|
| (Waiting for update.) | |
Mapped by lexical matching(Total Items:0) |
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| (Waiting for update.) |
Mapped by homologous gene(Total Items:0) |
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| (Waiting for update.) |
Chemical(Total Drugs:18) | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| CUI | ChemicalName | ChemicalID | CasRN | DiseaseName | DiseaseID | DirectEvidence | PubMedIDs | ||
| C0013395 | amitriptyline | D000639 | 50-48-6 | dyspepsia | MESH:D004415 | therapeutic | 15943846 | ||
| C0013395 | cimetidine | D002927 | 51481-61-9 | dyspepsia | MESH:D004415 | therapeutic | 630330 | ||
| C0013395 | cisapride | D020117 | 81098-60-4 | dyspepsia | MESH:D004415 | therapeutic | 10604046 | ||
| C0013395 | citalopram | D015283 | 59729-33-8 | dyspepsia | MESH:D004415 | marker/mechanism | 15765832 | ||
| C0013395 | codeine | D003061 | 76-57-3 | dyspepsia | MESH:D004415 | marker/mechanism | 9751092 | ||
| C0013395 | diclofenac | D004008 | 15307-86-5 | dyspepsia | MESH:D004415 | marker/mechanism | 1439622 | ||
| C0013395 | erythromycin | D004917 | 114-07-8 | dyspepsia | MESH:D004415 | therapeutic | 15238200 | ||
| C0013395 | fluvoxamine | D016666 | 54739-18-3 | dyspepsia | MESH:D004415 | marker/mechanism | 9164424 | ||
| C0013395 | indomethacin | D007213 | 53-86-1 | dyspepsia | MESH:D004415 | marker/mechanism | 4916769 | ||
| C0013395 | lansoprazole | D064747 | - | dyspepsia | MESH:D004415 | therapeutic | 15468341 | ||
| C0013395 | methotrexate | D008727 | 1959/5/2 | dyspepsia | MESH:D004415 | marker/mechanism | 6018206 | ||
| C0013395 | nizatidine | D016567 | 76963-41-2 | dyspepsia | MESH:D004415 | therapeutic | 7769203 | ||
| C0013395 | omeprazole | D009853 | 73590-58-6 | dyspepsia | MESH:D004415 | marker/mechanism | 17316343 | ||
| C0013395 | omeprazole | D009853 | 73590-58-6 | dyspepsia | MESH:D004415 | therapeutic | 17266883 | ||
| C0013395 | oxycodone | D010098 | 76-42-6 | dyspepsia | MESH:D004415 | marker/mechanism | 9751092 | ||
| C0013395 | pentagastrin | D010418 | 5534-95-2 | dyspepsia | MESH:D004415 | marker/mechanism | 18463442 | ||
| C0013395 | propranolol | D011433 | 525-66-6 | dyspepsia | MESH:D004415 | marker/mechanism | 5086971 | ||
| C0013395 | epoprostenol | D011464 | 35121-78-9 | dyspepsia | MESH:D004415 | marker/mechanism | 18936500 | ||
FDA approved drug and dosage information(Total Drugs:16) | ||||||||
|---|---|---|---|---|---|---|---|---|
| DiseaseID | Drug_name | active_ingredients | strength | Dosage Form/Route | Marketing Status | TE code | RLD | RS |
| MESH:D004415 | prilosec | omeprazole | 20MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons | CAPSULE, DELAYED REL PELLETS;ORAL | Discontinued | None | Yes | No |
| MESH:D004415 | prilosec | omeprazole | 20MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons | CAPSULE, DELAYED REL PELLETS;ORAL | Discontinued | None | Yes | No |
| MESH:D004415 | prilosec | omeprazole | 20MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons | CAPSULE, DELAYED REL PELLETS;ORAL | Discontinued | None | Yes | No |
| MESH:D004415 | prilosec | omeprazole | 20MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons | CAPSULE, DELAYED REL PELLETS;ORAL | Discontinued | None | Yes | No |
| MESH:D004415 | omeprazole | omeprazole | 20MG | TABLET, DELAYED RELEASE;ORAL | Over-the-counter | None | Yes | Yes |
| MESH:D004415 | omeprazole | omeprazole | 20MG | TABLET, DELAYED RELEASE;ORAL | Over-the-counter | None | Yes | Yes |
| MESH:D004415 | omeprazole | omeprazole | 20MG | TABLET, DELAYED RELEASE;ORAL | Over-the-counter | None | Yes | Yes |
| MESH:D004415 | omeprazole | omeprazole | 20MG | TABLET, DELAYED RELEASE;ORAL | Over-the-counter | None | Yes | Yes |
| MESH:D004415 | axid | nizatidine | 150MG | CAPSULE;ORAL | Discontinued | None | No | No |
| MESH:D004415 | axid | nizatidine | 15MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons | SOLUTION;ORAL | Discontinued | None | Yes | No |
| MESH:D004415 | prevacid | lansoprazole | 15MG | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | AB | Yes | No |
| MESH:D004415 | prevacid | lansoprazole | 15MG/PACKET | FOR SUSPENSION, DELAYED RELEASE;ORAL | Discontinued | None | No | No |
| MESH:D004415 | prevacid | lansoprazole | 15MG | TABLET, DELAYED RELEASE, ORALLY DISINTEGRATING;ORAL | Prescription | None | Yes | No |
| MESH:D004415 | prevacid | lansoprazole | 15MG | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | AB | Yes | No |
| MESH:D004415 | prevacid | lansoprazole | 15MG/PACKET | FOR SUSPENSION, DELAYED RELEASE;ORAL | Discontinued | None | No | No |
| MESH:D004415 | prevacid | lansoprazole | 15MG | TABLET, DELAYED RELEASE, ORALLY DISINTEGRATING;ORAL | Prescription | None | Yes | No |
FDA labeling changes(Total Drugs:16) | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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:D004415 | 12/7/2002 | prilosec | omeprazole | Gastroesophageal reflux and erosive esophagitis | Safety and effectiveness established in pediatric patients 2-16 years of age Information on dose, PK parameters, exposure/response and AE profile | Labeling | B | - | - | - | AstraZeneca | - | FALSE' |
| MESH:D004415 | 12/7/2002 | prilosec | omeprazole | Gastroesophageal reflux and erosive esophagitis | Safety and effectiveness established in pediatric patients 2-16 years of age Information on dose, PK parameters, exposure/response and AE profile | Labeling | B | - | - | - | AstraZeneca | - | FALSE' |
| MESH:D004415 | 03/20/2008 | prilosec | omeprazole | Maintenance healing of erosive esophagitis | Efficacy was extrapolated from adults and older children to 1 to 2 year olds and supported with an open-label trial Unique adverse reactions in pediatric patients included increased respiratory system adverse events and fever. Safety and effectiveness in children less than 1 year of age have not been established Dosing and administration information provided for patients 1 year and older weighing at least 5 kg. New dosage form | Labeling | - | - | B, P | - | AstraZeneca | 1/5/2001 | FALSE' |
| MESH:D004415 | 03/20/2008 | prilosec | omeprazole | Maintenance healing of erosive esophagitis | Efficacy was extrapolated from adults and older children to 1 to 2 year olds and supported with an open-label trial Unique adverse reactions in pediatric patients included increased respiratory system adverse events and fever. Safety and effectiveness in children less than 1 year of age have not been established Dosing and administration information provided for patients 1 year and older weighing at least 5 kg. New dosage form | Labeling | - | - | B, P | - | AstraZeneca | 1/5/2001 | FALSE' |
| MESH:D004415 | 12/7/2002 | prilosec | omeprazole | Gastroesophageal reflux and erosive esophagitis | Safety and effectiveness established in pediatric patients 2-16 years of age Information on dose, PK parameters, exposure/response and AE profile | Labeling | B | - | - | - | AstraZeneca | - | FALSE' |
| MESH:D004415 | 12/7/2002 | prilosec | omeprazole | Gastroesophageal reflux and erosive esophagitis | Safety and effectiveness established in pediatric patients 2-16 years of age Information on dose, PK parameters, exposure/response and AE profile | Labeling | B | - | - | - | AstraZeneca | - | FALSE' |
| MESH:D004415 | 03/20/2008 | prilosec | omeprazole | Maintenance healing of erosive esophagitis | Efficacy was extrapolated from adults and older children to 1 to 2 year olds and supported with an open-label trial Unique adverse reactions in pediatric patients included increased respiratory system adverse events and fever. Safety and effectiveness in children less than 1 year of age have not been established Dosing and administration information provided for patients 1 year and older weighing at least 5 kg. New dosage form | Labeling | - | - | B, P | - | AstraZeneca | 1/5/2001 | FALSE' |
| MESH:D004415 | 03/20/2008 | prilosec | omeprazole | Maintenance healing of erosive esophagitis | Efficacy was extrapolated from adults and older children to 1 to 2 year olds and supported with an open-label trial Unique adverse reactions in pediatric patients included increased respiratory system adverse events and fever. Safety and effectiveness in children less than 1 year of age have not been established Dosing and administration information provided for patients 1 year and older weighing at least 5 kg. New dosage form | Labeling | - | - | B, P | - | AstraZeneca | 1/5/2001 | FALSE' |
| MESH:D004415 | 05/25/2004 | axid | nizatidine | Esophagitis, and heartburn due to GERD | Indicated in pediatric patients 12 years and older Information on dose, PK parameters, and AE profile | Labeling | B | - | - | - | Reliant Pharms | - | FALSE' |
| MESH:D004415 | 05/25/2004 | axid | nizatidine | Esophagitis, and heartburn due to GERD | Indicated in pediatric patients 12 years and older Information on dose, PK parameters, and AE profile | Labeling | B | - | - | - | Reliant Pharms | - | FALSE' |
| MESH:D004415 | 06/17/2004 | prevacid | lansoprazole | Short-term treatment of symptomatic GERD and erosive Esophagitis | Expanded age range to include patients 12 -17 years of age; previously labeled only in pediatric patients 1-11 years of age Safety and effectiveness in pediatric patients | Labeling | B | - | - | - | Tap | 07/15/2008 | FALSE' |
| MESH:D004415 | 06/17/2004 | prevacid | lansoprazole | Short-term treatment of symptomatic GERD and erosive Esophagitis | Expanded age range to include patients 12 -17 years of age; previously labeled only in pediatric patients 1-11 years of age Safety and effectiveness in pediatric patients | Labeling | B | - | - | - | Tap | 07/15/2008 | FALSE' |
| MESH:D004415 | 06/17/2004 | prevacid | lansoprazole | Short-term treatment of symptomatic GERD and erosive Esophagitis | Expanded age range to include patients 12 -17 years of age; previously labeled only in pediatric patients 1-11 years of age Safety and effectiveness in pediatric patients | Labeling | B | - | - | - | Tap | 07/15/2008 | FALSE' |
| MESH:D004415 | 10/28/2008 | prevacid | lansoprazole | Symptomatic GERD in infants | Effectiveness was not established in a 4 week multicenter, double-blind, placebo-controlled study of patients 1 month and < 12 months of age AE profile similar to that observed in adultsInformation on PK parameters in neonates to < 1 year, and clinical studies | Labeling | - | - | B, P | - | Takeda | 07/15/2008 | FALSE' |
| MESH:D004415 | 10/28/2008 | prevacid | lansoprazole | Symptomatic GERD in infants | Effectiveness was not established in a 4 week multicenter, double-blind, placebo-controlled study of patients 1 month and < 12 months of age AE profile similar to that observed in adultsInformation on PK parameters in neonates to < 1 year, and clinical studies | Labeling | - | - | B, P | - | Takeda | 07/15/2008 | FALSE' |
| MESH:D004415 | 10/28/2008 | prevacid | lansoprazole | Symptomatic GERD in infants | Effectiveness was not established in a 4 week multicenter, double-blind, placebo-controlled study of patients 1 month and < 12 months of age AE profile similar to that observed in adultsInformation on PK parameters in neonates to < 1 year, and clinical studies | Labeling | - | - | B, P | - | Takeda | 07/15/2008 | FALSE' |