PedAM
Pediatric Disease Annotations & Medicines
| diarrhea | ||||
| Disease ID | 727 |
|---|---|
| Disease | diarrhea |
| Manually Symptom | (Waiting for update.) |
| Text Mined Symptom | UMLS | Name | Sentences' Count(Total Symptoms:23) C0009450 | infection | 139 C0030193 | pain | 90 C0011175 | dehydration | 84 C0000737 | abdominal pain | 59 C0021311 | infections | 49 C0022104 | irritable bowel syndrome | 46 C0009319 | colitis | 35 C0024523 | malabsorption | 23 C0162429 | malnutrition | 12 C0014833 | escherichia | 8 C0178238 | intestinal infection | 7 C0796095 | c syndrome | 6 C0010418 | cryptosporidiosis | 6 C0021167 | incontinence | 5 C0343386 | clostridium difficile infection | 5 C0400821 | microscopic colitis | 3 C0422833 | ent symptoms | 3 C0021832 | intestinal parasites | 2 C0267963 | exocrine pancreatic insufficiency | 1 C0206044 | calicivirus infection | 1 C0035869 | rotavirus infections | 1 C0004663 | bacteroides fragilis | 1 C0020456 | hyperglycemia | 1 |
Manually Genotype(Total Text Mining Genotypes:0) |
|---|
| (Waiting for update.) |
All Snps(Total Genotypes:24) | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| snpId | pubmedId | geneId | geneSymbol | diseaseId | sourceId | sentence | score | Year | geneSymbol_dbSNP | CHROMOSOME | POS | REF | ALT |
| rs1045642 | 23543295 | 2952 | GSTT1 | umls:C0011991 | BeFree | In irinotecan-treated patients, T allele of ABCB1C1236T SNP was associated with a lower risk of asthenia(OR = 0.047; 95 % CI = 0.004–0.493; P = 0.011) and Tallele of ABCB1 C3435T SNP was associated with a lower risk of diarrhea (OR = 0.177; 95 % CI = 0.034–0.919;P = 0.039), and individuals with two copies of GSTT1 gene had a lower risk for asthenia (OR = 0.093; 95 %CI = 0.011–0.794; P = 0.030). | 0.000271442 | 2013 | ABCB1 | 7 | 87509329 | A | T,G |
| rs1045642 | 19349543 | 5243 | ABCB1 | umls:C0011991 | BeFree | PG analysis showed that ABCB1 (C3435T)T/T (membrane transport) was associated with IP-related diarrhea; UGT1A1 (G-3156A)A/A (drug metabolism) was associated with IP-related neutropenia. | 0.001085767 | 2009 | ABCB1 | 7 | 87509329 | A | T,G |
| rs1045642 | 23543295 | 5243 | ABCB1 | umls:C0011991 | BeFree | In irinotecan-treated patients, T allele of ABCB1C1236T SNP was associated with a lower risk of asthenia(OR = 0.047; 95 % CI = 0.004–0.493; P = 0.011) and Tallele of ABCB1 C3435T SNP was associated with a lower risk of diarrhea (OR = 0.177; 95 % CI = 0.034–0.919;P = 0.039), and individuals with two copies of GSTT1 gene had a lower risk for asthenia (OR = 0.093; 95 %CI = 0.011–0.794; P = 0.030). | 0.001085767 | 2013 | ABCB1 | 7 | 87509329 | A | T,G |
| rs1045642 | 19349543 | 54658 | UGT1A1 | umls:C0011991 | BeFree | PG analysis showed that ABCB1 (C3435T)T/T (membrane transport) was associated with IP-related diarrhea; UGT1A1 (G-3156A)A/A (drug metabolism) was associated with IP-related neutropenia. | 0.015711291 | 2009 | ABCB1 | 7 | 87509329 | A | T,G |
| rs1137101 | 25516614 | 3953 | LEPR | umls:C0011991 | BeFree | The Q223R leptin receptor mutation results in increased susceptibility of children and adults to E. histolytica, one of the leading causes of diarrhea morbidity and mortality in children of the developing world. | 0.000271442 | 2015 | LEPR | 1 | 65592830 | A | G |
| rs17376848 | 25677447 | 118429 | ANTXR2 | umls:C0011991 | BeFree | DPYD T85C, T1896C and A2846T mutant variants were associated with diarrhea (P < 0.05) and HFS (P < 0.02), and IVS14+1G>A additionally with diarrhea (P < 0.001). | 0.000271442 | 2015 | DPYD | 1 | 97450068 | A | G |
| rs17376848 | 25677447 | 1806 | DPYD | umls:C0011991 | BeFree | DPYD T85C, T1896C and A2846T mutant variants were associated with diarrhea (P < 0.05) and HFS (P < 0.02), and IVS14+1G>A additionally with diarrhea (P < 0.001). | 0.003724241 | 2015 | DPYD | 1 | 97450068 | A | G |
| rs17868320 | 22912756 | 54600 | UGT1A9 | umls:C0011991 | BeFree | Multivariate analysis showed that increased cumulated sorafenib (AUC(cum)) was independently associated with any grade ≥ 3 toxicity (p = 0.037); UGT1A9 polymorphism (rs17868320) with grade ≥ 2 diarrhea (p = 0.015) and female gender with grade ≥ 2 hand-foot skin reaction (p = 0.018). | 0.005005506 | 2012 | UGT1A10;UGT1A8 | 2 | 233669782 | C | T |
| rs2231142 | 17148776 | 9429 | ABCG2 | umls:C0011991 | BeFree | One variant, a common functional single-nucleotide polymorphism (SNP) in the ABCG2 gene, was associated with diarrhea in 124 patients treated with oral gefitinib 250 mg once daily; seven (44%) of 16 patients heterozygous for ABCG2 421C>A (Q141K) developed diarrhea, versus only 13 (12%) of 108 patients homozygous for the wild-type sequence (P = .0046). | 0.006091273 | 2006 | ABCG2 | 4 | 88131171 | G | T |
| rs2231142 | 19032367 | 1649 | DDIT3 | umls:C0011991 | BeFree | This study demonstrates that the ABCG2 Q141K polymorphism may correlate with chemotherapy-induced diarrhea in patients with DLBCL who have received frontline R-CHOP chemotherapy, and this has implications for optimizing treatment with such agents. | 0.000271442 | 2008 | ABCG2 | 4 | 88131171 | G | T |
| rs2231142 | 19032367 | 9429 | ABCG2 | umls:C0011991 | BeFree | ABCG2 Q141K polymorphism is associated with chemotherapy-induced diarrhea in patients with diffuse large B-cell lymphoma who received frontline rituximab plus cyclophosphamide/doxorubicin/vincristine/prednisone chemotherapy. | 0.006091273 | 2008 | ABCG2 | 4 | 88131171 | G | T |
| rs2231142 | 19032367 | 80316 | PPP1R2P9 | umls:C0011991 | BeFree | On multivariate analysis, grade I-IV diarrhea was statistically significant according to ABCG2 Q141K polymorphism (the QQ genotype vs the QK or KK genotypes; hazard ratio 2.835; 95% confidence interval 1.432-5.613; P = 0.003). | 0.000271442 | 2008 | ABCG2 | 4 | 88131171 | G | T |
| rs2244613 | 25611302 | 1066 | CES1 | umls:C0011991 | BeFree | Reduced risk of neutropenia and diarrhoea was associated with ABCC2-24C/T (odds ratio (OR)=0.22, 0.06-0.85) and CES1 (rs2244613; OR=0.29, 0.09-0.89), respectively. | 0.000542884 | 2014 | CES1 | 16 | 55810697 | G | T |
| rs2244613 | 25611302 | 1244 | ABCC2 | umls:C0011991 | BeFree | Reduced risk of neutropenia and diarrhoea was associated with ABCC2-24C/T (odds ratio (OR)=0.22, 0.06-0.85) and CES1 (rs2244613; OR=0.29, 0.09-0.89), respectively. | 0.003181358 | 2014 | CES1 | 16 | 55810697 | G | T |
| rs386467430 | 25677447 | 118429 | ANTXR2 | umls:C0011991 | BeFree | DPYD T85C, T1896C and A2846T mutant variants were associated with diarrhea (P < 0.05) and HFS (P < 0.02), and IVS14+1G>A additionally with diarrhea (P < 0.001). | 0.000271442 | 2015 | NA | NA | NA | NA | NA |
| rs386467430 | 25381393 | 1806 | DPYD | umls:C0011991 | BeFree | The DPYD*2A variant statistically significantly associated with the specific AEs nausea/vomiting (P = .007) and neutropenia (P < .001), whereas D949V statistically significantly associated with dehydration (P = .02), diarrhea (P = .003), leukopenia (P = .002), neutropenia (P < .001), and thrombocytopenia (P < .001). | 0.003724241 | 2015 | NA | NA | NA | NA | NA |
| rs386467430 | 25677447 | 1806 | DPYD | umls:C0011991 | BeFree | DPYD T85C, T1896C and A2846T mutant variants were associated with diarrhea (P < 0.05) and HFS (P < 0.02), and IVS14+1G>A additionally with diarrhea (P < 0.001). | 0.003724241 | 2015 | NA | NA | NA | NA | NA |
| rs67376798 | 25677447 | 1806 | DPYD | umls:C0011991 | BeFree | DPYD T85C, T1896C and A2846T mutant variants were associated with diarrhea (P < 0.05) and HFS (P < 0.02), and IVS14+1G>A additionally with diarrhea (P < 0.001). | 0.003724241 | 2015 | DPYD | 1 | 97082391 | T | A |
| rs67376798 | 25677447 | 118429 | ANTXR2 | umls:C0011991 | BeFree | DPYD T85C, T1896C and A2846T mutant variants were associated with diarrhea (P < 0.05) and HFS (P < 0.02), and IVS14+1G>A additionally with diarrhea (P < 0.001). | 0.000271442 | 2015 | DPYD | 1 | 97082391 | T | A |
| rs67376798 | 25381393 | 1806 | DPYD | umls:C0011991 | BeFree | The DPYD*2A variant statistically significantly associated with the specific AEs nausea/vomiting (P = .007) and neutropenia (P < .001), whereas D949V statistically significantly associated with dehydration (P = .02), diarrhea (P = .003), leukopenia (P = .002), neutropenia (P < .001), and thrombocytopenia (P < .001). | 0.003724241 | 2015 | DPYD | 1 | 97082391 | T | A |
| rs712829 | 20159991 | 1956 | EGFR | umls:C0011991 | BeFree | In contrast, EGFR-activating mutations were significantly correlated with response, longer time-to-progression, and overall survival, whereas EGFR -191C/A (P < 0.001), -216 G/T (P < 0.01), and R497K (P = 0.02) polymorphisms were strongly associated with grade >1 diarrhea. | 0.006905599 | 2010 | EGFR | 7 | 55019062 | G | T |
| rs712830 | 20159991 | 1956 | EGFR | umls:C0011991 | BeFree | In contrast, EGFR-activating mutations were significantly correlated with response, longer time-to-progression, and overall survival, whereas EGFR -191C/A (P < 0.001), -216 G/T (P < 0.01), and R497K (P = 0.02) polymorphisms were strongly associated with grade >1 diarrhea. | 0.006905599 | 2010 | EGFR | 7 | 55019087 | A | C |
| rs717620 | 17060857 | 1244 | ABCC2 | umls:C0011991 | BeFree | Patients with the MRP2 C-24T variant had significantly more diarrhea in the first year after transplantation. | 0.003181358 | 2006 | ABCC2 | 10 | 99782821 | C | T |
| rs9351963 | 25127363 | 56479 | KCNQ5 | umls:C0011991 | BeFree | These results suggest that rs9351963 in KCNQ5 is a possible predictive factor of incidence of diarrhea in cancer patients treated with irinotecan chemotherapy and for selecting chemotherapy regimens, such as irinotecan alone or a combination of irinotecan with a KCNQ5 opener. | 0.000271442 | 2014 | KCNQ5 | 6 | 73040138 | A | C |
GWASdb Annotation(Total Genotypes:0) | |
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| (Waiting for update.) | |
GWASdb Snp Trait(Total Genotypes:0) | |
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| (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:116) | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| CUI | ChemicalName | ChemicalID | CasRN | DiseaseName | DiseaseID | DirectEvidence | PubMedIDs | ||
| C0011991 | amifostine | D004999 | 20537-88-6 | diarrhea | MESH:D003967 | therapeutic | 10971385 | ||
| C0011991 | amlodipine | D017311 | 88150-42-9 | diarrhea | MESH:D003967 | marker/mechanism | 18201582 | ||
| C0011991 | amodiaquine | D000655 | 86-42-0 | diarrhea | MESH:D003967 | marker/mechanism | 974497 | ||
| C0011991 | ampicillin | D000667 | 69-53-4 | diarrhea | MESH:D003967 | marker/mechanism | 2306432 | ||
| C0011991 | amsacrine | D000677 | - | diarrhea | MESH:D003967 | marker/mechanism | 2410119 | ||
| C0011991 | atropine | D001285 | 51-55-8 | diarrhea | MESH:D003967 | therapeutic | 10867622 | ||
| C0011991 | azacitidine | D001374 | 320-67-2 | diarrhea | MESH:D003967 | marker/mechanism | 2410119 | ||
| C0011991 | azithromycin | D017963 | 83905-01-5 | diarrhea | MESH:D003967 | marker/mechanism | 10326742 | ||
| C0011991 | azithromycin | D017963 | 83905-01-5 | diarrhea | MESH:D003967 | therapeutic | 12145722 | ||
| C0011991 | bisoprolol | D017298 | 66722-44-9 | diarrhea | MESH:D003967 | marker/mechanism | 15662077 | ||
| C0011991 | bleomycin | D001761 | 11056-06-7 | diarrhea | MESH:D003967 | marker/mechanism | 7534090 | ||
| C0011991 | bortezomib | D000069286 | - | diarrhea | MESH:D003967 | marker/mechanism | 15161691 | ||
| C0011991 | buspirone | D002065 | 36505-84-7 | diarrhea | MESH:D003967 | marker/mechanism | 10928399 | ||
| C0011991 | busulfan | D002066 | 55-98-1 | diarrhea | MESH:D003967 | marker/mechanism | 11019834 | ||
| C0011991 | caffeine | D002110 | 1958/8/2 | diarrhea | MESH:D003967 | marker/mechanism | 7217021 | ||
| C0011991 | carbachol | D002217 | - | diarrhea | MESH:D003967 | marker/mechanism | 20350559 | ||
| C0011991 | cefotaxime | D002439 | 63527-52-6 | diarrhea | MESH:D003967 | marker/mechanism | 2041948 | ||
| C0011991 | celecoxib | D000068579 | - | diarrhea | MESH:D003967 | marker/mechanism | 19246950 | ||
| C0011991 | cephalexin | D002506 | 15686-71-2 | diarrhea | MESH:D003967 | marker/mechanism | 15222673 | ||
| C0011991 | chlordiazepoxide | D002707 | 58-25-3 | diarrhea | MESH:D003967 | marker/mechanism | 2000517 | ||
| C0011991 | chlorpromazine | D002746 | 50-53-3 | diarrhea | MESH:D003967 | marker/mechanism | 4247303 | ||
| C0011991 | cimetidine | D002927 | 51481-61-9 | diarrhea | MESH:D003967 | marker/mechanism | 375397 | ||
| C0011991 | ciprofloxacin | D002939 | 85721-33-1 | diarrhea | MESH:D003967 | marker/mechanism | 10440621 | ||
| C0011991 | ciprofloxacin | D002939 | 85721-33-1 | diarrhea | MESH:D003967 | therapeutic | 24101390 | ||
| C0011991 | citalopram | D015283 | 59729-33-8 | diarrhea | MESH:D003967 | marker/mechanism | 12691792 | ||
| C0011991 | clofazimine | D002991 | 2030-63-9 | diarrhea | MESH:D003967 | marker/mechanism | 16295502 | ||
| C0011991 | clozapine | D003024 | 5786-21-0 | diarrhea | MESH:D003967 | marker/mechanism | 1527237 | ||
| C0011991 | codeine | D003061 | 76-57-3 | diarrhea | MESH:D003967 | therapeutic | 7237001 | ||
| C0011991 | colchicine | D003078 | 64-86-8 | diarrhea | MESH:D003967 | marker/mechanism | 16240705 | ||
| C0011991 | creatine | D003401 | 57-00-1 | diarrhea | MESH:D003967 | marker/mechanism | 11740307 | ||
| C0011991 | crizotinib | C551994 | - | diarrhea | MESH:D003967 | marker/mechanism | 21757253 | ||
| C0011991 | cyclophosphamide | D003520 | 50-18-0 | diarrhea | MESH:D003967 | marker/mechanism | 10084258 | ||
| C0011991 | cyclosporine | D016572 | 59865-13-3 | diarrhea | MESH:D003967 | marker/mechanism | 18156240 | ||
| C0011991 | cyclosporine | D016572 | 59865-13-3 | diarrhea | MESH:D003967 | therapeutic | 23619107 | ||
| C0011991 | deferasirox | C415250 | - | diarrhea | MESH:D003967 | marker/mechanism | 17233848 | ||
| C0011991 | cisplatin | D002945 | 15663-27-1 | diarrhea | MESH:D003967 | marker/mechanism | 11104554 | ||
| C0011991 | diclofenac | D004008 | 15307-86-5 | diarrhea | MESH:D003967 | marker/mechanism | 1439622 | ||
| C0011991 | zalcitabine | D016047 | 7481-89-2 | diarrhea | MESH:D003967 | marker/mechanism | 12403023 | ||
| C0011991 | diethylstilbestrol | D004054 | 56-53-1 | diarrhea | MESH:D003967 | marker/mechanism | 5171004 | ||
| C0011991 | digoxin | D004077 | 20830-75-5 | diarrhea | MESH:D003967 | marker/mechanism | 20466255 | ||
| C0011991 | droxidopa | D015103 | 23651-95-8 | diarrhea | MESH:D003967 | therapeutic | 986992 | ||
| C0011991 | diltiazem | D004110 | 42399-41-7 | diarrhea | MESH:D003967 | marker/mechanism | 2699494 | ||
| C0011991 | doxycycline | D004318 | 564-25-0 | diarrhea | MESH:D003967 | marker/mechanism | 10879639 | ||
| C0011991 | enalapril | D004656 | 75847-73-3 | diarrhea | MESH:D003967 | marker/mechanism | 15662077 | ||
| C0011991 | epirubicin | D015251 | 56420-45-2 | diarrhea | MESH:D003967 | marker/mechanism | 3458431 | ||
| C0011991 | everolimus | D000068338 | - | diarrhea | MESH:D003967 | marker/mechanism | 16951235 | ||
| C0011991 | felbamate | C047360 | 25451-15-4 | diarrhea | MESH:D003967 | marker/mechanism | 9848129 | ||
| C0011991 | fenfluramine | D005277 | 458-24-2 | diarrhea | MESH:D003967 | marker/mechanism | 4895336 | ||
| C0011991 | floxuridine | D005467 | 50-91-9 | diarrhea | MESH:D003967 | marker/mechanism | 6199474 | ||
| C0011991 | fluorouracil | D005472 | 51-21-8 | diarrhea | MESH:D003967 | marker/mechanism | 11432626 | ||
| C0011991 | fluoxetine | D005473 | 54910-89-3 | diarrhea | MESH:D003967 | marker/mechanism | 10928399 | ||
| C0011991 | leucovorin | D002955 | 1958/5/9 | diarrhea | MESH:D003967 | marker/mechanism | 11432626 | ||
| C0011991 | gefitinib | C419708 | 184475-35-2 | diarrhea | MESH:D003967 | marker/mechanism | 15196742 | ||
| C0011991 | gemcitabine | C056507 | 103882-84-4 | diarrhea | MESH:D003967 | marker/mechanism | 10955861 | ||
| C0011991 | hydroxyurea | D006918 | 127-07-1 | diarrhea | MESH:D003967 | marker/mechanism | 12620292 | ||
| C0011991 | imatinib mesylate | D000068877 | - | diarrhea | MESH:D003967 | marker/mechanism | 17405756 | ||
| C0011991 | indomethacin | D007213 | 53-86-1 | diarrhea | MESH:D003967 | marker/mechanism | 16240705 | ||
| C0011991 | indomethacin | D007213 | 53-86-1 | diarrhea | MESH:D003967 | therapeutic | 7237001 | ||
| C0011991 | labetalol | D007741 | 36894-69-6 | diarrhea | MESH:D003967 | marker/mechanism | 672730 | ||
| C0011991 | lactulose | D007792 | 4618-18-2 | diarrhea | MESH:D003967 | marker/mechanism | 234288 | ||
| C0011991 | lansoprazole | D064747 | - | diarrhea | MESH:D003967 | marker/mechanism | 11012560 | ||
| C0011991 | linezolid | D000069349 | - | diarrhea | MESH:D003967 | marker/mechanism | 14520146 | ||
| C0011991 | loracarbef | C054920 | - | diarrhea | MESH:D003967 | marker/mechanism | 1621751 | ||
| C0011991 | lorazepam | D008140 | 846-49-1 | diarrhea | MESH:D003967 | marker/mechanism | 4040158 | ||
| C0011991 | mebendazole | D008463 | 31431-39-7 | diarrhea | MESH:D003967 | marker/mechanism | 7330947 | ||
| C0011991 | mefloquine | D015767 | 53230-10-7 | diarrhea | MESH:D003967 | marker/mechanism | 12962582 | ||
| C0011991 | meloxicam | C065757 | 71125-38-7 | diarrhea | MESH:D003967 | marker/mechanism | 20073572 | ||
| C0011991 | melphalan | D008558 | 148-82-3 | diarrhea | MESH:D003967 | marker/mechanism | 10971385 | ||
| C0011991 | mesna | D015080 | 19767-45-4 | diarrhea | MESH:D003967 | marker/mechanism | 1677714 | ||
| C0011991 | metformin | D008687 | 657-24-9 | diarrhea | MESH:D003967 | marker/mechanism | 14604317 | ||
| C0011991 | dextromethorphan | D003915 | 125-71-3 | diarrhea | MESH:D003967 | marker/mechanism | 6375709 | ||
| C0011991 | methotrexate | D008727 | 1959/5/2 | diarrhea | MESH:D003967 | marker/mechanism | 1450620 | ||
| C0011991 | miglustat | C059896 | - | diarrhea | MESH:D003967 | marker/mechanism | 17067996 | ||
| C0011991 | mitomycin | D016685 | 1950/7/7 | diarrhea | MESH:D003967 | marker/mechanism | 12119460 | ||
| C0011991 | mitoxantrone | D008942 | 65271-80-9 | diarrhea | MESH:D003967 | marker/mechanism | 1802019 | ||
| C0011991 | morphine | D009020 | 57-27-2 | diarrhea | MESH:D003967 | therapeutic | 2540324 | ||
| C0011991 | moxifloxacin | C104727 | - | diarrhea | MESH:D003967 | marker/mechanism | 20731847 | ||
| C0011991 | nelfinavir | D019888 | 159989-64-7 | diarrhea | MESH:D003967 | marker/mechanism | 10708286 | ||
| C0011991 | nevirapine | D019829 | 129618-40-2 | diarrhea | MESH:D003967 | marker/mechanism | 10950090 | ||
| C0011991 | nicotine | D009538 | - | diarrhea | MESH:D003967 | marker/mechanism | 2371153 | ||
| C0011991 | octreotide | D015282 | 83150-76-9 | diarrhea | MESH:D003967 | marker/mechanism | 2508821 | ||
| C0011991 | octreotide | D015282 | 83150-76-9 | diarrhea | MESH:D003967 | therapeutic | 10720019 | ||
| C0011991 | ofloxacin | D015242 | 82419-36-1 | diarrhea | MESH:D003967 | marker/mechanism | 10190377 | ||
| C0011991 | omeprazole | D009853 | 73590-58-6 | diarrhea | MESH:D003967 | marker/mechanism | 11012560 | ||
| C0011991 | omeprazole | D009853 | 73590-58-6 | diarrhea | MESH:D003967 | therapeutic | 8071518 | ||
| C0011991 | oxaliplatin | C030110 | - | diarrhea | MESH:D003967 | marker/mechanism | 11432626 | ||
| C0011991 | oxytetracycline | D010118 | 79-57-2 | diarrhea | MESH:D003967 | marker/mechanism | 7364640 | ||
| C0011991 | paclitaxel | D017239 | - | diarrhea | MESH:D003967 | marker/mechanism | 10955861 | ||
| C0011991 | paclitaxel | D017239 | - | diarrhea | MESH:D003967 | therapeutic | 16332718 | ||
| C0011991 | pantoprazole | C064276 | 102625-70-7 | diarrhea | MESH:D003967 | marker/mechanism | 11012560 | ||
| C0011991 | pantoprazole | C064276 | 102625-70-7 | diarrhea | MESH:D003967 | therapeutic | 11173893 | ||
| C0011991 | peginterferon alfa-2b | C417083 | - | diarrhea | MESH:D003967 | marker/mechanism | 20721883 | ||
| C0011991 | propylthiouracil | D011441 | 51-52-5 | diarrhea | MESH:D003967 | marker/mechanism | 15822032 | ||
| C0011991 | raltitrexed | C068874 | - | diarrhea | MESH:D003967 | marker/mechanism | 11528249 | ||
| C0011991 | rifampin | D012293 | 13292-46-1 | diarrhea | MESH:D003967 | therapeutic | 24101390 | ||
| C0011991 | sirolimus | D020123 | 53123-88-9 | diarrhea | MESH:D003967 | marker/mechanism | 15102967 | ||
| C0011991 | sorafenib | C471405 | - | diarrhea | MESH:D003967 | marker/mechanism | 18796127 | ||
| C0011991 | spironolactone | D013148 | 1952/1/7 | diarrhea | MESH:D003967 | marker/mechanism | 11250985 | ||
| C0011991 | spironolactone | D013148 | 1952/1/7 | diarrhea | MESH:D003967 | therapeutic | 24101390 | ||
| C0011991 | tacrolimus | D016559 | 109581-93-3 | diarrhea | MESH:D003967 | marker/mechanism | 8605372 | ||
| C0011991 | temsirolimus | C401859 | - | diarrhea | MESH:D003967 | marker/mechanism | 20430774 | ||
| C0011991 | thiethylperazine | D013847 | 1420-55-9 | diarrhea | MESH:D003967 | therapeutic | 9348575 | ||
| C0011991 | thiopental | D013874 | 76-75-5 | diarrhea | MESH:D003967 | marker/mechanism | 7900578 | ||
| C0011991 | thiotepa | D013852 | 52-24-4 | diarrhea | MESH:D003967 | marker/mechanism | 11019834 | ||
| C0011991 | ticlopidine | D013988 | 55142-85-3 | diarrhea | MESH:D003967 | marker/mechanism | 16211203 | ||
| C0011991 | timolol | D013999 | 26839-75-8 | diarrhea | MESH:D003967 | marker/mechanism | 8434677 | ||
| C0011991 | tinidazole | D014011 | 19387-91-8 | diarrhea | MESH:D003967 | marker/mechanism | 11173893 | ||
| C0011991 | topiramate | C052342 | 97240-79-4 | diarrhea | MESH:D003967 | therapeutic | 21849664 | ||
| C0011991 | tretinoin | D014212 | 302-79-4 | diarrhea | MESH:D003967 | marker/mechanism | 4685585 | ||
| C0011991 | vancomycin | D014640 | 1404-90-6 | diarrhea | MESH:D003967 | marker/mechanism | 21148517 | ||
| C0011991 | vinblastine | D014747 | 865-21-4 | diarrhea | MESH:D003967 | marker/mechanism | 11104554 | ||
| C0011991 | vincristine | D014750 | - | diarrhea | MESH:D003967 | marker/mechanism | 4294312 | ||
| C0011991 | vindesine | D014751 | 53643-48-4 | diarrhea | MESH:D003967 | marker/mechanism | 6249481 | ||
| C0011991 | vinorelbine | C030852 | 71486-22-1 | diarrhea | MESH:D003967 | marker/mechanism | 15196742 | ||
| C0011991 | vorinostat | C111237 | - | diarrhea | MESH:D003967 | marker/mechanism | 20479100 | ||
| C0011991 | zidovudine | D015215 | 30516-87-1 | diarrhea | MESH:D003967 | marker/mechanism | 12403023 | ||
FDA approved drug and dosage information(Total Drugs:54) | ||||||||
|---|---|---|---|---|---|---|---|---|
| DiseaseID | Drug_name | active_ingredients | strength | Dosage Form/Route | Marketing Status | TE code | RLD | RS |
| MESH:D003967 | 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:D003967 | 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:D003967 | 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:D003967 | 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:D003967 | omeprazole | omeprazole | 20MG | TABLET, DELAYED RELEASE;ORAL | Over-the-counter | None | Yes | Yes |
| MESH:D003967 | omeprazole | omeprazole | 20MG | TABLET, DELAYED RELEASE;ORAL | Over-the-counter | None | Yes | Yes |
| MESH:D003967 | omeprazole | omeprazole | 20MG | TABLET, DELAYED RELEASE;ORAL | Over-the-counter | None | Yes | Yes |
| MESH:D003967 | omeprazole | omeprazole | 20MG | TABLET, DELAYED RELEASE;ORAL | Over-the-counter | None | Yes | Yes |
| MESH:D003967 | zyvox | linezolid | 400MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons | TABLET;ORAL | Discontinued | None | Yes | No |
| MESH:D003967 | zyvox | linezolid | 200MG/100ML (2MG/ML) | SOLUTION;IV (INFUSION) | Prescription | AP | Yes | No |
| MESH:D003967 | zyvox | linezolid | 100MG/5ML | FOR SUSPENSION;ORAL | Prescription | AB | Yes | Yes |
| MESH:D003967 | zyvox | linezolid | 400MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons | TABLET;ORAL | Discontinued | None | Yes | No |
| MESH:D003967 | zyvox | linezolid | 200MG/100ML (2MG/ML) | SOLUTION;IV (INFUSION) | Prescription | AP | Yes | No |
| MESH:D003967 | zyvox | linezolid | 100MG/5ML | FOR SUSPENSION;ORAL | Prescription | AB | Yes | Yes |
| MESH:D003967 | busulfex | busulfan | 6MG/ML | INJECTABLE;INJECTION | Prescription | AP | Yes | Yes |
| MESH:D003967 | cipro | ciprofloxacin | 400MG/40ML (10MG/ML) | INJECTABLE;INJECTION | Discontinued | None | Yes | No |
| MESH:D003967 | cipro | ciprofloxacin | 400MG/40ML (10MG/ML) | INJECTABLE;INJECTION | Discontinued | None | Yes | No |
| MESH:D003967 | cipro | ciprofloxacin | 250MG/5ML | FOR SUSPENSION;ORAL | Prescription | AB | Yes | No |
| MESH:D003967 | cipro | ciprofloxacin | 250MG/5ML | FOR SUSPENSION;ORAL | Prescription | AB | Yes | No |
| MESH:D003967 | prevacid | lansoprazole | 15MG | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | AB | Yes | No |
| MESH:D003967 | prevacid | lansoprazole | 15MG/PACKET | FOR SUSPENSION, DELAYED RELEASE;ORAL | Discontinued | None | No | No |
| MESH:D003967 | prevacid | lansoprazole | 15MG | TABLET, DELAYED RELEASE, ORALLY DISINTEGRATING;ORAL | Prescription | None | Yes | No |
| MESH:D003967 | prevacid | lansoprazole | 15MG | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | AB | Yes | No |
| MESH:D003967 | prevacid | lansoprazole | 15MG/PACKET | FOR SUSPENSION, DELAYED RELEASE;ORAL | Discontinued | None | No | No |
| MESH:D003967 | prevacid | lansoprazole | 15MG | TABLET, DELAYED RELEASE, ORALLY DISINTEGRATING;ORAL | Prescription | None | Yes | No |
| MESH:D003967 | rapamune | sirolimus | 1MG/ML | SOLUTION;ORAL | Prescription | None | Yes | Yes |
| MESH:D003967 | rapamune | sirolimus | 1MG | TABLET;ORAL | Prescription | AB | Yes | No |
| MESH:D003967 | mobic | meloxicam | 7.5MG | TABLET;ORAL | Prescription | AB | Yes | No |
| MESH:D003967 | mobic | meloxicam | 7.5MG/5ML | SUSPENSION;ORAL | Prescription | None | Yes | Yes |
| MESH:D003967 | gleevec | imatinib mesylate | EQ 50MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons | CAPSULE;ORAL | Discontinued | None | Yes | No |
| MESH:D003967 | gleevec | imatinib mesylate | EQ 100MG BASE | TABLET;ORAL | Prescription | AB | Yes | No |
| MESH:D003967 | celebrex | celecoxib | 100MG | CAPSULE;ORAL | Prescription | AB | Yes | No |
| MESH:D003967 | celebrex | celecoxib | 100MG | CAPSULE;ORAL | Prescription | None | No | No |
| MESH:D003967 | eloxatin | oxaliplatin | 50MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons | INJECTABLE;IV (INFUSION) | Discontinued | None | Yes | No |
| MESH:D003967 | eloxatin | oxaliplatin | 50MG/10ML (5MG/ML) | INJECTABLE;IV (INFUSION) | Prescription | AP | Yes | Yes |
| MESH:D003967 | oxaliplatin | oxaliplatin | 50MG/10ML (5MG/ML) | INJECTABLE;IV (INFUSION) | Prescription | AP | Yes | Yes |
| MESH:D003967 | retrovir | zidovudine | 100MG | CAPSULE;ORAL | Prescription | AB | Yes | Yes |
| MESH:D003967 | retrovir | zidovudine | 50MG/5ML | SYRUP;ORAL | Prescription | AA | Yes | Yes |
| MESH:D003967 | retrovir | zidovudine | 10MG/ML | INJECTABLE;INJECTION | Prescription | AP | Yes | Yes |
| MESH:D003967 | retrovir | zidovudine | 200MG | TABLET;ORAL | Discontinued | None | No | No |
| MESH:D003967 | zidovudine | zidovudine | 60MG | TABLET;ORAL | Discontinued | None | No | No |
| MESH:D003967 | zidovudine | zidovudine | 60MG | TABLET;ORAL | Discontinued | None | No | No |
| MESH:D003967 | topamax | topiramate | 100MG | TABLET;ORAL | Prescription | AB | Yes | Yes |
| MESH:D003967 | topamax | topiramate | 15MG | CAPSULE;ORAL | Prescription | AB | Yes | No |
| MESH:D003967 | topamax | topiramate | 100MG | TABLET;ORAL | Prescription | AB | Yes | Yes |
| MESH:D003967 | topamax | topiramate | 15MG | CAPSULE;ORAL | Prescription | AB | Yes | No |
| MESH:D003967 | topamax | topiramate | 100MG | TABLET;ORAL | Prescription | AB | Yes | Yes |
| MESH:D003967 | topamax | topiramate | 15MG | CAPSULE;ORAL | Prescription | AB | Yes | No |
| MESH:D003967 | topamax | topiramate | 100MG | TABLET;ORAL | Prescription | AB | Yes | Yes |
| MESH:D003967 | topamax | topiramate | 15MG | CAPSULE;ORAL | Prescription | AB | Yes | No |
| MESH:D003967 | afinitor | everolimus | 5MG | TABLET;ORAL | Prescription | None | Yes | No |
| MESH:D003967 | torisel | temsirolimus | 25MG/ML (25MG/ML) | SOLUTION;INTRAVENOUS | Prescription | None | Yes | Yes |
| MESH:D003967 | exjade | deferasirox | 125MG | TABLET, FOR SUSPENSION;ORAL | Prescription | AB | Yes | No |
| MESH:D003967 | velcade | bortezomib | 3.5MG/VIAL | INJECTABLE;INTRAVENOUS, SUBCUTANEOUS | Prescription | None | Yes | Yes |
FDA labeling changes(Total Drugs:54) | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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:D003967 | 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:D003967 | 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:D003967 | 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:D003967 | 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:D003967 | 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:D003967 | 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:D003967 | 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:D003967 | 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:D003967 | 12/19/2002 | zyvox | linezolid | Nosocomial pneumonia, community-acquired pneumonia, complicated and uncomplicated skin and skin structure infections, and vancomycin-resistant infections caused by susceptible strains | Extended age range down to birth for nosocomial pneumonia, community-acquired pneumonia, complicated skin and skin structure infections and vancomycin-resistant infections. Safety and efficacy extrapolated from studies in adults and supported by PK and comparator-controlled studies in patients from birth to 11 years Extended age range down to 5 years of age for uncomplicated skin and skin structure infections based upon a comparator-controlled study in 5 to 17 year olds Clearance of linezolid varies as a function of age; As age of pediatric patients increases, clearance gradually decreases, and by adolescence mean clearance values approach those observed in adults Pediatric patients exhibit wider variability in clearance and systemic exposure (AUC) compared with adults New every 8 hours dosing regimen for pediatric patients birth to 11 years of age and every 12 hours dosing regimen for pediatric patients 12 years and older Information on PK parameters, AE profile, laboratory changes, dosing, and clinical studies | Labeling | B | - | - | - | Pfizer | 11/2/2005 | FALSE' |
| MESH:D003967 | 12/19/2002 | zyvox | linezolid | Nosocomial pneumonia, community-acquired pneumonia, complicated and uncomplicated skin and skin structure infections, and vancomycin-resistant infections caused by susceptible strains | Extended age range down to birth for nosocomial pneumonia, community-acquired pneumonia, complicated skin and skin structure infections and vancomycin-resistant infections. Safety and efficacy extrapolated from studies in adults and supported by PK and comparator-controlled studies in patients from birth to 11 years Extended age range down to 5 years of age for uncomplicated skin and skin structure infections based upon a comparator-controlled study in 5 to 17 year olds Clearance of linezolid varies as a function of age; As age of pediatric patients increases, clearance gradually decreases, and by adolescence mean clearance values approach those observed in adults Pediatric patients exhibit wider variability in clearance and systemic exposure (AUC) compared with adults New every 8 hours dosing regimen for pediatric patients birth to 11 years of age and every 12 hours dosing regimen for pediatric patients 12 years and older Information on PK parameters, AE profile, laboratory changes, dosing, and clinical studies | Labeling | B | - | - | - | Pfizer | 11/2/2005 | FALSE' |
| MESH:D003967 | 12/19/2002 | zyvox | linezolid | Nosocomial pneumonia, community-acquired pneumonia, complicated and uncomplicated skin and skin structure infections, and vancomycin-resistant infections caused by susceptible strains | Extended age range down to birth for nosocomial pneumonia, community-acquired pneumonia, complicated skin and skin structure infections and vancomycin-resistant infections. Safety and efficacy extrapolated from studies in adults and supported by PK and comparator-controlled studies in patients from birth to 11 years Extended age range down to 5 years of age for uncomplicated skin and skin structure infections based upon a comparator-controlled study in 5 to 17 year olds Clearance of linezolid varies as a function of age; As age of pediatric patients increases, clearance gradually decreases, and by adolescence mean clearance values approach those observed in adults Pediatric patients exhibit wider variability in clearance and systemic exposure (AUC) compared with adults New every 8 hours dosing regimen for pediatric patients birth to 11 years of age and every 12 hours dosing regimen for pediatric patients 12 years and older Information on PK parameters, AE profile, laboratory changes, dosing, and clinical studies | Labeling | B | - | - | - | Pfizer | 11/2/2005 | FALSE' |
| MESH:D003967 | 12/5/2005 | zyvox | linezolid | Central nervous system infections | PK data in pediatric patients with ventriculoperitoneal shunts showed variable cerebrospinal fluid (CSF) concentrations; therapeutic concentrations were not consistently achieved or maintained in the CSF Use of linezolid for the empiric treatment of pediatric patients with central nervous system infections is not recommended Additional information on efficacy in pediatric patients with infectious vancomycin-resistant Enterococcus faecium | Labeling | B | - | - | - | Pfizer | 11/2/2005 | FALSE' |
| MESH:D003967 | 12/5/2005 | zyvox | linezolid | Central nervous system infections | PK data in pediatric patients with ventriculoperitoneal shunts showed variable cerebrospinal fluid (CSF) concentrations; therapeutic concentrations were not consistently achieved or maintained in the CSF Use of linezolid for the empiric treatment of pediatric patients with central nervous system infections is not recommended Additional information on efficacy in pediatric patients with infectious vancomycin-resistant Enterococcus faecium | Labeling | B | - | - | - | Pfizer | 11/2/2005 | FALSE' |
| MESH:D003967 | 12/5/2005 | zyvox | linezolid | Central nervous system infections | PK data in pediatric patients with ventriculoperitoneal shunts showed variable cerebrospinal fluid (CSF) concentrations; therapeutic concentrations were not consistently achieved or maintained in the CSF Use of linezolid for the empiric treatment of pediatric patients with central nervous system infections is not recommended Additional information on efficacy in pediatric patients with infectious vancomycin-resistant Enterococcus faecium | Labeling | B | - | - | - | Pfizer | 11/2/2005 | FALSE' |
| MESH:D003967 | 01/13/2003 | busulfex | busulfan | Part of a conditioning regimen administered prior to hematopoietic progenitor cell transplantation for a variety of malignant hematologic or non-malignant diseases | The population pharmacokinetic estimates of busulfan for clearance and volume of distribution were determined in an open-label, uncontrolled PK study in 24 pediatric patients 5 months to 16 years who received busulfan as part of a conditioning regimen administered prior to hematopoietic progenitor cell transplantation for a variety of malignant hematologic or non-malignant diseases Suggested dosing regimen | Labeling | B | - | - | - | Orphan Medical | 12/3/2002 | FALSE' |
| MESH:D003967 | 03/25/2004 | cipro | ciprofloxacin | Complicated UTI and pyelonephritis | Indicated for the treatment of complicated urinary tract infections (cUTIs) and pyelonephritis in pediatric patients 1 17 years of age Not drug of first choice due to increased adverse events compared to controls including events related to joints and/or surrounding tissues Information on PK and dose in pediatric patients 1 17 years of age The most frequent adverse events observed within 6 weeks of treatment initiation during the cUTI clinical trial were gastrointestinal 15% compared to 9% and musculoskeletal 9.3% compared to 6% in ciprofloxacin-treated compared to control-treated patients, respectively | Labeling | B | - | - | - | Bayer | 12/18/2003 | FALSE' |
| MESH:D003967 | 03/25/2004 | cipro | ciprofloxacin | Complicated UTI and pyelonephritis | Indicated for the treatment of complicated urinary tract infections (cUTIs) and pyelonephritis in pediatric patients 1 17 years of age Not drug of first choice due to increased adverse events compared to controls including events related to joints and/or surrounding tissues Information on PK and dose in pediatric patients 1 17 years of age The most frequent adverse events observed within 6 weeks of treatment initiation during the cUTI clinical trial were gastrointestinal 15% compared to 9% and musculoskeletal 9.3% compared to 6% in ciprofloxacin-treated compared to control-treated patients, respectively | Labeling | B | - | - | - | Bayer | 12/18/2003 | FALSE' |
| MESH:D003967 | 03/25/2004 | cipro | ciprofloxacin | Complicated UTI and pyelonephritis | Indicated for the treatment of complicated urinary tract infections (cUTIs) and pyelonephritis in pediatric patients 1 17 years of age Not drug of first choice due to increased adverse events compared to controls including events related to joints and/or surrounding tissues Information on PK and dose in pediatric patients 1 17 years of age The most frequent adverse events observed within 6 weeks of treatment initiation during the cUTI clinical trial were gastrointestinal 15% compared to 9% and musculoskeletal 9.3% compared to 6% in ciprofloxacin-treated compared to control-treated patients, respectively | Labeling | B | - | - | - | Bayer | 12/18/2003 | FALSE' |
| MESH:D003967 | 03/25/2004 | cipro | ciprofloxacin | Complicated UTI and pyelonephritis | Indicated for the treatment of complicated urinary tract infections (cUTIs) and pyelonephritis in pediatric patients 1 17 years of age Not drug of first choice due to increased adverse events compared to controls including events related to joints and/or surrounding tissues Information on PK and dose in pediatric patients 1 17 years of age The most frequent adverse events observed within 6 weeks of treatment initiation during the cUTI clinical trial were gastrointestinal 15% compared to 9% and musculoskeletal 9.3% compared to 6% in ciprofloxacin-treated compared to control-treated patients, respectively | Labeling | B | - | - | - | Bayer | 12/18/2003 | FALSE' |
| MESH:D003967 | 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:D003967 | 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:D003967 | 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:D003967 | 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:D003967 | 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:D003967 | 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:D003967 | 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:D003967 | 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:D003967 | 11/8/2005 | mobic | meloxicam | Relief of signs and symptoms of pauciarticular or polyarticular course Juvenile Rheumatoid Arthritis | Safety and efficacy established in patients 2 years of age and older Clinical studies evaluated doses ranging from 0.125 mg/kg/day to 0.375 mg/kg/day. There was no additional benefit demonstrated by doses above 0.125 mg/kg/day in the clinical trials. The lowest effective dose should be used Adverse events in children were similar to those in adults including skin reactions and gastrointestinal bleed risk Information on dose, PK parameters, AE profile and clinical studies | Labeling | - | - | B, P | - | Boehringer Ingelheim | 04/15/2005 | FALSE' |
| MESH:D003967 | 11/8/2005 | mobic | meloxicam | Relief of signs and symptoms of pauciarticular or polyarticular course Juvenile Rheumatoid Arthritis | Safety and efficacy established in patients 2 years of age and older Clinical studies evaluated doses ranging from 0.125 mg/kg/day to 0.375 mg/kg/day. There was no additional benefit demonstrated by doses above 0.125 mg/kg/day in the clinical trials. The lowest effective dose should be used Adverse events in children were similar to those in adults including skin reactions and gastrointestinal bleed risk Information on dose, PK parameters, AE profile and clinical studies | Labeling | - | - | B, P | - | Boehringer Ingelheim | 04/15/2005 | FALSE' |
| MESH:D003967 | 09/27/2006 | gleevec | imatinib mesylate | Treatment of newly diagnosed pediatric patients with Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase | Extended age range for the treatment of newly diagnosed CML down to pediatric patients There are no data in children < 2 years of age Follow-up in children with newly diagnosed Ph+ chronic phase CML is limited Information on hematologic toxicities, AE profile, clinical studies and dosing guidelines new for newly diagnosed pediatric patients | Labeling | - | - | B, P | - | Novartis | 9/6/2006 | FALSE' |
| MESH:D003967 | 09/27/2006 | gleevec | imatinib mesylate | Treatment of newly diagnosed pediatric patients with Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase | Extended age range for the treatment of newly diagnosed CML down to pediatric patients There are no data in children < 2 years of age Follow-up in children with newly diagnosed Ph+ chronic phase CML is limited Information on hematologic toxicities, AE profile, clinical studies and dosing guidelines new for newly diagnosed pediatric patients | Labeling | - | - | B, P | - | Novartis | 9/6/2006 | FALSE' |
| MESH:D003967 | 12/15/2006 | celebrex | celecoxib | Relief of the signs and symptoms of juvenile rheumatoid arthritis (JRA) | New indication in 2 years and older Has not been studied in patients < 2 years, in patients with body weight < 10 kg, or in patients with active systemic features Celecoxib should be used only with caution in patients with systemic onset JRA due to the risk for serious adverse reactions including the risk of disseminated intravascular coagulation The long-term cardiovascular toxicity in children has not been evaluated; it is unknown if the long-term risk may be similar to that seen in adults New 50 mg capsule developed Information on adding contents of a capsule to applesauce. for patients with difficulty swallowing capsules Information on dose, clinical studies, PK parameters, AEs | Labeling | B | - | - | - | Pfizer | 08/23/2006 | FALSE' |
| MESH:D003967 | 12/15/2006 | celebrex | celecoxib | Relief of the signs and symptoms of juvenile rheumatoid arthritis (JRA) | New indication in 2 years and older Has not been studied in patients < 2 years, in patients with body weight < 10 kg, or in patients with active systemic features Celecoxib should be used only with caution in patients with systemic onset JRA due to the risk for serious adverse reactions including the risk of disseminated intravascular coagulation The long-term cardiovascular toxicity in children has not been evaluated; it is unknown if the long-term risk may be similar to that seen in adults New 50 mg capsule developed Information on adding contents of a capsule to applesauce. for patients with difficulty swallowing capsules Information on dose, clinical studies, PK parameters, AEs | Labeling | B | - | - | - | Pfizer | 08/23/2006 | FALSE' |
| MESH:D003967 | 10/1/2007 | eloxatin | oxaliplatin | Solid tumors | The effectiveness of oxaliplatin in children has not been established No significant activity observed in 2 Phase I and 2 Phase II trials in 159 patients ages 7 months to 22 years with solid tumors Information on clinical studies and AEs | Labeling | B | - | - | - | Sanofi-Aventis | 09/27/2006 | FALSE' |
| MESH:D003967 | 10/1/2007 | eloxatin | oxaliplatin | Solid tumors | The effectiveness of oxaliplatin in children has not been established No significant activity observed in 2 Phase I and 2 Phase II trials in 159 patients ages 7 months to 22 years with solid tumors Information on clinical studies and AEs | Labeling | B | - | - | - | Sanofi-Aventis | 09/27/2006 | FALSE' |
| MESH:D003967 | 10/1/2007 | eloxatin | oxaliplatin | Solid tumors | The effectiveness of oxaliplatin in children has not been established No significant activity observed in 2 Phase I and 2 Phase II trials in 159 patients ages 7 months to 22 years with solid tumors Information on clinical studies and AEs | Labeling | B | - | - | - | Sanofi-Aventis | 09/27/2006 | FALSE' |
| MESH:D003967 | 6/11/2009 | retrovir | zidovudine | Treatment of HIV-1 infection in combination with other antiretroviral agents | Provided dosing recommendations for patients 4 weeks to < 6 weeks of age and weighing 4 kg to < 9 kg | Labeling | - | P | - | - | GlaxoSmithKline | - | TRUE' |
| MESH:D003967 | 6/11/2009 | retrovir | zidovudine | Treatment of HIV-1 infection in combination with other antiretroviral agents | Provided dosing recommendations for patients 4 weeks to < 6 weeks of age and weighing 4 kg to < 9 kg | Labeling | - | P | - | - | GlaxoSmithKline | - | TRUE' |
| MESH:D003967 | 6/11/2009 | retrovir | zidovudine | Treatment of HIV-1 infection in combination with other antiretroviral agents | Provided dosing recommendations for patients 4 weeks to < 6 weeks of age and weighing 4 kg to < 9 kg | Labeling | - | P | - | - | GlaxoSmithKline | - | TRUE' |
| MESH:D003967 | 6/11/2009 | retrovir | zidovudine | Treatment of HIV-1 infection in combination with other antiretroviral agents | Provided dosing recommendations for patients 4 weeks to < 6 weeks of age and weighing 4 kg to < 9 kg | Labeling | - | P | - | - | GlaxoSmithKline | - | TRUE' |
| MESH:D003967 | 09/19/2008 | retrovir syrup, capsules and tablets | zidovudine | Used in combination with 18 other antiretroviral agents for the treatment of HIV-1 infection | Dosing and administration information provided to children 6 weeks to less than 18 years of age Macrocytosis was reported in the majority of pediatric patients receiving Retrovir 180 mg/m2 every 6 hours in open-label studies New dosing regimen | Labeling | - | P | - | - | GlaxoSmithKline | - | TRUE' |
| MESH:D003967 | 6/11/2009 | retrovir | zidovudine | Treatment of HIV-1 infection in combination with other antiretroviral agents | Provided dosing recommendations for patients 4 weeks to < 6 weeks of age and weighing 4 kg to < 9 kg | Labeling | - | P | - | - | GlaxoSmithKline | - | TRUE' |
| MESH:D003967 | 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:D003967 | 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:D003967 | 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:D003967 | 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:D003967 | 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:D003967 | 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:D003967 | 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:D003967 | 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:D003967 | 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:D003967 | 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' |
| MESH:D003967 | 01/23/2013 | exjade | deferasirox | Treatment of chronic iron overload in patients with non-transfusion dependent thalassemia | Approved for use in 10 years and older for NTDT Safety and effectiveness have not been established in pediatric patients less than 10 years Information on dosing, adverse reactions in adults and pediatric patients, and clinical trials New indication | Labeling | - | P | - | - | Novalar Pharmaceuticals, Inc. | - | FALSE' |
| MESH:D003967 | 09/14/2015 | velcade | bortezomib | Relapsed Acute Lymphoblastic Leukemia (ALL) and Lymphoblastic Lymphoma (LL) | Effectiveness in pediatric patients with relapsed pre-B ALL has not been established. The activity and safety of Velcade in combination with intensive reinduction chemotherapy was evaluated in pediatric and young adult patients with lymphoid malignancies. There were 140 patients with ALL or LL enrolled and evaluated for safety. No new safety concerns were observed | Labeling | B | - | - | - | Millennium Pharmaceuticals, Inc. | - | FALSE |