thrombocytopenia |
Disease ID | 124 |
---|---|
Disease | thrombocytopenia |
Manually Symptom | UMLS | Name(Total Manually Symptoms:82) C2707258 | infections C2697310 | sarcoidosis C2364133 | infection C2364050 | hypothermia C2186532 | liver disease C1962966 | retinopathy C1962958 | hematoma C1660219 | analgesia C1623038 | cirrhosis C1521999 | acute myocardial infarction C1509147 | histiocytoma C1508749 | capillary fragility C1443043 | myeloproliferative syndromes C1387528 | acute hemolytic anemia C1384590 | hemangiomatosis C1333817 | giant hemangioma C1275974 | splenic hamartoma C1275974 | hamartoma of spleen C1268935 | microangiopathic hemolytic anemia C1142517 | lupus anticoagulant C1027109 | scleroderma C0948824 | hemorrhagic anemia C0948089 | acute coronary syndrome C0917798 | cerebral ischemia C0878643 | epiphenomenon C0796110 | w syndrome C0796095 | c syndrome C0728731 | prematurity C0685201 | splenic hemangioma C0600502 | hemostatic disorders C0398686 | primary immunodeficiency C0346424 | splenic angiosarcoma C0338575 | sagittal sinus thrombosis C0334121 | inflammatory myofibroblastic tumor C0282607 | vascular tumors C0272412 | splenic abscess C0267373 | intestinal bleeding C0265053 | lower extremity thrombophlebitis C0221025 | kasabach-merritt syndrome C0221021 | microangiopathic haemolytic anaemia C0206255 | malaria C0152915 | disseminated tuberculosis C0151945 | cerebral vein thrombosis C0085669 | acute leukemia C0085278 | antiphospholipid syndrome C0042974 | von willebrand's disease C0040156 | thyrotoxicosis C0040053 | thrombosis C0035021 | relapsing fever C0034150 | purpuras C0034150 | purpura C0032285 | pneumonia C0032001 | pituitary apoplexy C0031256 | petechiae C0029927 | ovarian cyst C0029166 | oral manifestations C0027051 | myocardial infarction C0026848 | myopathy C0026691 | kawasaki disease C0023794 | lipidosis C0023418 | leukemia C0021051 | immunodeficiency disorder C0021051 | immunodeficiency C0020532 | hypersplenism C0019693 | hiv infection C0019618 | histiocytosis C0019189 | chronic hepatitis C0019101 | hemorrhagic fever with renal syndrome C0019087 | hemorrhagic diathesis C0019087 | haemorrhagic diathesis C0019080 | hemorrhage C0018916 | hemangiomas C0018916 | hemangioma C0017181 | gastrointestinal hemorrhage C0010823 | cmv infection C0006309 | brucellosis C0005956 | bone marrow disease C0005818 | platelet disorders C0005818 | blood platelet disorders C0005779 | coagulopathy C0002879 | acquired hemolytic anemia C0002878 | hemolytic anemia |
Text Mined Symptom | UMLS | Name | Sentences' Count(Total Symptoms:41) C0040053 | thrombosis | 41 C0009450 | infection | 34 C0002878 | hemolytic anemia | 30 C0019080 | hemorrhage | 24 C0023895 | liver disease | 22 C0019189 | chronic hepatitis | 21 C0023890 | cirrhosis | 18 C0024530 | malaria | 17 C0020532 | hypersplenism | 14 C0796095 | c syndrome | 14 C0023418 | leukemia | 13 C0005779 | coagulopathy | 12 C0221021 | microangiopathic hemolytic anemia | 9 C0021311 | infections | 8 C0034150 | purpura | 8 C0267373 | intestinal bleeding | 7 C0948089 | acute coronary syndrome | 5 C0020672 | hypothermia | 4 C0032285 | pneumonia | 4 C0085669 | acute leukemia | 3 C0085278 | antiphospholipid syndrome | 3 C0021051 | immunodeficiency | 3 C0398686 | primary immunodeficiency | 3 C0019087 | hemorrhagic diathesis | 2 C0006309 | brucellosis | 2 C0018916 | hemangiomas | 2 C0027051 | myocardial infarction | 2 C0031256 | petechiae | 2 C0221021 | microangiopathic haemolytic anaemia | 2 C0085240 | lupus anticoagulant | 1 C0021051 | immunodeficiency disorder | 1 C0728731 | prematurity | 1 C0036202 | sarcoidosis | 1 C0221025 | kasabach-merritt syndrome | 1 C0019101 | hemorrhagic fever with renal syndrome | 1 C0346424 | splenic angiosarcoma | 1 C0018944 | hematoma | 1 C0032001 | pituitary apoplexy | 1 C0035309 | retinopathy | 1 C0019693 | hiv infection | 1 C0010823 | cmv infection | 1 |
Manually Genotype(Total Text Mining Genotypes:0) |
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(Waiting for update.) |
All Snps(Total Genotypes:2) | |||||||||||||
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snpId | pubmedId | geneId | geneSymbol | diseaseId | sourceId | sentence | score | Year | geneSymbol_dbSNP | CHROMOSOME | POS | REF | ALT |
rs786205154 | NA | 2120 | ETV6 | umls:C0040034 | CLINVAR | NA | 0.24 | NA | ETV6 | 12 | 11885921 | AACAG | - |
rs786205155 | NA | 2120 | ETV6 | umls:C0040034 | CLINVAR | NA | 0.24 | NA | ETV6 | 12 | 11884481 | T | C |
GWASdb Annotation(Total Genotypes:0) | |
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(Waiting for update.) |
GWASdb Snp Trait(Total Genotypes:2) | |||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
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 |
5 | 176842474 | rs2731672 | T | C | rs2731672 | 21546496 | 1.00E-06 | FXII levels | NA | NA | 70 children | NOPOP(70) | ALL(70) | NOPOP(70) | ALL(70) | Platelet function and related traits | HPOID:0011869 | Abnormal platelet function | DOID:2218 | DOID:3393 | blood platelet disease | coronary artery disease | D013921 | Thrombocytopenia | NA | NA | Vascular disease | Hemorrhagic disorder | Thrombocytosis |
20 | 3381549 | rs965469 | T | C | rs965469 | 21703177 | 1.00E-09 | IFN-related thrombocytopenia at wk 4 | NA | NA | 984 European ancestry with genotype 1 HCV; 201 African Americans ancestry with genotype 1 HCV; 99 Hispanics ancestry with genotype 1 HCV | African American(201) | European(984) | Hispanic(99) | ALL(1284) | HIS(99) | AFR(201) | EUR(984) | ALL(1284) | IFN-related cytopenia | HPOID:0001871 | Abnormality of blood and blood-forming tissues | DOID:1588 | DOID:1227 | thrombocytopenia | neutropenia | D013921 | Thrombocytopenia | EFOID:0004220 |
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:86) | |||||||||
---|---|---|---|---|---|---|---|---|---|
CUI | ChemicalName | ChemicalID | CasRN | DiseaseName | DiseaseID | DirectEvidence | PubMedIDs | ||
C0040034 | amifostine | D004999 | 20537-88-6 | thrombocytopenia | MESH:D013921 | therapeutic | 1333372 | ||
C0040034 | aminocaproic acid | D015119 | 60-32-2 | thrombocytopenia | MESH:D013921 | marker/mechanism | 6537999 | ||
C0040034 | aminosalicylic acid | D010131 | 65-49-6 | thrombocytopenia | MESH:D013921 | marker/mechanism | 5434719 | ||
C0040034 | amitriptyline | D000639 | 50-48-6 | thrombocytopenia | MESH:D013921 | marker/mechanism | 910638 | ||
C0040034 | ampicillin | D000667 | 69-53-4 | thrombocytopenia | MESH:D013921 | marker/mechanism | 5101527 | ||
C0040034 | argatroban | C031942 | 74863-84-6 | thrombocytopenia | MESH:D013921 | therapeutic | 11269422 | ||
C0040034 | arsenic trioxide | C006632 | 1327-53-3 | thrombocytopenia | MESH:D013921 | marker/mechanism | 17497326 | ||
C0040034 | aspartame | D001218 | 22839-47-0 | thrombocytopenia | MESH:D013921 | marker/mechanism | 17534100 | ||
C0040034 | bivalirudin | C074619 | 128270-60-0 | thrombocytopenia | MESH:D013921 | therapeutic | 16651880 | ||
C0040034 | bleomycin | D001761 | 11056-06-7 | thrombocytopenia | MESH:D013921 | marker/mechanism | 54212 | ||
C0040034 | bortezomib | D000069286 | - | thrombocytopenia | MESH:D013921 | marker/mechanism | 15738379 | ||
C0040034 | busulfan | D002066 | 55-98-1 | thrombocytopenia | MESH:D013921 | marker/mechanism | 16543071 | ||
C0040034 | carbamazepine | D002220 | 298-46-4 | thrombocytopenia | MESH:D013921 | marker/mechanism | 12897634 | ||
C0040034 | carbimazole | D002231 | 22232-54-8 | thrombocytopenia | MESH:D013921 | marker/mechanism | 10848805 | ||
C0040034 | carmustine | D002330 | 154-93-8 | thrombocytopenia | MESH:D013921 | marker/mechanism | 12494480 | ||
C0040034 | cetirizine | D017332 | 83881-51-0 | thrombocytopenia | MESH:D013921 | marker/mechanism | 17955500 | ||
C0040034 | chloramphenicol | D002701 | 56-75-7 | thrombocytopenia | MESH:D013921 | marker/mechanism | 6071896 | ||
C0040034 | cladribine | D017338 | 4291-63-8 | thrombocytopenia | MESH:D013921 | marker/mechanism | 12181031 | ||
C0040034 | cimetidine | D002927 | 51481-61-9 | thrombocytopenia | MESH:D013921 | marker/mechanism | 7427548 | ||
C0040034 | ciprofloxacin | D002939 | 85721-33-1 | thrombocytopenia | MESH:D013921 | marker/mechanism | 12022900 | ||
C0040034 | colchicine | D003078 | 64-86-8 | thrombocytopenia | MESH:D013921 | marker/mechanism | 16240705 | ||
C0040034 | cyclophosphamide | D003520 | 50-18-0 | thrombocytopenia | MESH:D013921 | marker/mechanism | 12406105 | ||
C0040034 | cyclosporine | D016572 | 59865-13-3 | thrombocytopenia | MESH:D013921 | marker/mechanism | 12469693 | ||
C0040034 | cyclosporine | D016572 | 59865-13-3 | thrombocytopenia | MESH:D013921 | therapeutic | 10410193 | ||
C0040034 | cisplatin | D002945 | 15663-27-1 | thrombocytopenia | MESH:D013921 | marker/mechanism | 11135224 | ||
C0040034 | cisplatin | D002945 | 15663-27-1 | thrombocytopenia | MESH:D013921 | therapeutic | 24158386 | ||
C0040034 | diclofenac | D004008 | 15307-86-5 | thrombocytopenia | MESH:D013921 | marker/mechanism | 11051389 | ||
C0040034 | epirubicin | D015251 | 56420-45-2 | thrombocytopenia | MESH:D013921 | marker/mechanism | 11557123 | ||
C0040034 | eptifibatide | C086648 | - | thrombocytopenia | MESH:D013921 | marker/mechanism | 17008982 | ||
C0040034 | ethambutol | D004977 | 74-55-5 | thrombocytopenia | MESH:D013921 | marker/mechanism | 188103 | ||
C0040034 | ethosuximide | D005013 | 77-67-8 | thrombocytopenia | MESH:D013921 | marker/mechanism | 623072 | ||
C0040034 | everolimus | D000068338 | - | thrombocytopenia | MESH:D013921 | marker/mechanism | 10551636 | ||
C0040034 | fenoprofen | D005279 | 31879-05-7 | thrombocytopenia | MESH:D013921 | marker/mechanism | 6228839 | ||
C0040034 | fluconazole | D015725 | 86386-73-4 | thrombocytopenia | MESH:D013921 | marker/mechanism | 24459006 | ||
C0040034 | fluorouracil | D005472 | 51-21-8 | thrombocytopenia | MESH:D013921 | marker/mechanism | 12119460 | ||
C0040034 | folic acid | D005492 | 59-30-3 | thrombocytopenia | MESH:D013921 | therapeutic | 8958188 | ||
C0040034 | leucovorin | D002955 | 1958/5/9 | thrombocytopenia | MESH:D013921 | marker/mechanism | 12119460 | ||
C0040034 | leucovorin | D002955 | 1958/5/9 | thrombocytopenia | MESH:D013921 | therapeutic | 6607976 | ||
C0040034 | gefitinib | C419708 | 184475-35-2 | thrombocytopenia | MESH:D013921 | marker/mechanism | 15196742 | ||
C0040034 | gemcitabine | C056507 | 103882-84-4 | thrombocytopenia | MESH:D013921 | marker/mechanism | 10526274 | ||
C0040034 | haloperidol | D006220 | 52-86-8 | thrombocytopenia | MESH:D013921 | marker/mechanism | 9637888 | ||
C0040034 | hydroxyurea | D006918 | 127-07-1 | thrombocytopenia | MESH:D013921 | marker/mechanism | 12620292 | ||
C0040034 | ifosfamide | D007069 | 3778-73-2 | thrombocytopenia | MESH:D013921 | marker/mechanism | 15150579 | ||
C0040034 | indomethacin | D007213 | 53-86-1 | thrombocytopenia | MESH:D013921 | marker/mechanism | 12632374 | ||
C0040034 | lenalidomide | C467567 | - | thrombocytopenia | MESH:D013921 | marker/mechanism | 17723971 | ||
C0040034 | lepirudin | C083544 | - | thrombocytopenia | MESH:D013921 | therapeutic | 15333046 | ||
C0040034 | linezolid | D000069349 | - | thrombocytopenia | MESH:D013921 | marker/mechanism | 11794421 | ||
C0040034 | mefloquine | D015767 | 53230-10-7 | thrombocytopenia | MESH:D013921 | marker/mechanism | 8161647 | ||
C0040034 | melphalan | D008558 | 148-82-3 | thrombocytopenia | MESH:D013921 | marker/mechanism | 10656432 | ||
C0040034 | meprobamate | D008620 | 57-53-4 | thrombocytopenia | MESH:D013921 | marker/mechanism | 5092569 | ||
C0040034 | methotrexate | D008727 | 1959/5/2 | thrombocytopenia | MESH:D013921 | marker/mechanism | 16246977 | ||
C0040034 | mitomycin | D016685 | 1950/7/7 | thrombocytopenia | MESH:D013921 | marker/mechanism | 12119460 | ||
C0040034 | mitoxantrone | D008942 | 65271-80-9 | thrombocytopenia | MESH:D013921 | marker/mechanism | 10597740 | ||
C0040034 | omeprazole | D009853 | 73590-58-6 | thrombocytopenia | MESH:D013921 | marker/mechanism | 9695674 | ||
C0040034 | oxaliplatin | C030110 | - | thrombocytopenia | MESH:D013921 | marker/mechanism | 15274380 | ||
C0040034 | paclitaxel | D017239 | - | thrombocytopenia | MESH:D013921 | marker/mechanism | 10037178 | ||
C0040034 | paclitaxel | D017239 | - | thrombocytopenia | MESH:D013921 | therapeutic | 16332718 | ||
C0040034 | pefloxacin | D015366 | 70458-92-3 | thrombocytopenia | MESH:D013921 | marker/mechanism | 2258351 | ||
C0040034 | pegfilgrastim | C455861 | - | thrombocytopenia | MESH:D013921 | marker/mechanism | 20547415 | ||
C0040034 | peginterferon alfa-2b | C417083 | - | thrombocytopenia | MESH:D013921 | marker/mechanism | 16637862 | ||
C0040034 | phenytoin | D010672 | 57-41-0 | thrombocytopenia | MESH:D013921 | marker/mechanism | 1147459 | ||
C0040034 | propranolol | D011433 | 525-66-6 | thrombocytopenia | MESH:D013921 | therapeutic | 11871761 | ||
C0040034 | propylthiouracil | D011441 | 51-52-5 | thrombocytopenia | MESH:D013921 | marker/mechanism | 566489 | ||
C0040034 | pyrazinamide | D011718 | 98-96-4 | thrombocytopenia | MESH:D013921 | marker/mechanism | 5434719 | ||
C0040034 | quinine | D011803 | 130-95-0 | thrombocytopenia | MESH:D013921 | marker/mechanism | 10474732 | ||
C0040034 | raltitrexed | C068874 | - | thrombocytopenia | MESH:D013921 | marker/mechanism | 11528249 | ||
C0040034 | ribavirin | D012254 | 36791-04-5 | thrombocytopenia | MESH:D013921 | marker/mechanism | 15081101 | ||
C0040034 | rifampin | D012293 | 13292-46-1 | thrombocytopenia | MESH:D013921 | marker/mechanism | 11798598 | ||
C0040034 | sirolimus | D020123 | 53123-88-9 | thrombocytopenia | MESH:D013921 | marker/mechanism | 10221490 | ||
C0040034 | streptozocin | D013311 | 18883-66-4 | thrombocytopenia | MESH:D013921 | marker/mechanism | 135666 | ||
C0040034 | tacrolimus | D016559 | 109581-93-3 | thrombocytopenia | MESH:D013921 | marker/mechanism | 12753543 | ||
C0040034 | temozolomide | C047246 | 85622-93-1 | thrombocytopenia | MESH:D013921 | marker/mechanism | 17108062 | ||
C0040034 | thalidomide | D013792 | 50-35-1 | thrombocytopenia | MESH:D013921 | marker/mechanism | 24928523 | ||
C0040034 | thiotepa | D013852 | 52-24-4 | thrombocytopenia | MESH:D013921 | marker/mechanism | 2121628 | ||
C0040034 | ticlopidine | D013988 | 55142-85-3 | thrombocytopenia | MESH:D013921 | marker/mechanism | 20031738 | ||
C0040034 | tinidazole | D014011 | 19387-91-8 | thrombocytopenia | MESH:D013921 | marker/mechanism | 7123 | ||
C0040034 | valproic acid | D014635 | 99-66-1 | thrombocytopenia | MESH:D013921 | marker/mechanism | 10698845 | ||
C0040034 | vancomycin | D014640 | 1404-90-6 | thrombocytopenia | MESH:D013921 | marker/mechanism | 14520145 | ||
C0040034 | vinblastine | D014747 | 865-21-4 | thrombocytopenia | MESH:D013921 | marker/mechanism | 54212 | ||
C0040034 | vincristine | D014750 | - | thrombocytopenia | MESH:D013921 | marker/mechanism | 11305414 | ||
C0040034 | vincristine | D014750 | - | thrombocytopenia | MESH:D013921 | therapeutic | 2981498 | ||
C0040034 | vindesine | D014751 | 53643-48-4 | thrombocytopenia | MESH:D013921 | marker/mechanism | 3857971 | ||
C0040034 | vinorelbine | C030852 | 71486-22-1 | thrombocytopenia | MESH:D013921 | marker/mechanism | 10526274 | ||
C0040034 | vorinostat | C111237 | - | thrombocytopenia | MESH:D013921 | marker/mechanism | 18854394 | ||
C0040034 | zidovudine | D015215 | 30516-87-1 | thrombocytopenia | MESH:D013921 | marker/mechanism | 18240862 | ||
C0040034 | zidovudine | D015215 | 30516-87-1 | thrombocytopenia | MESH:D013921 | therapeutic | 3190058 |
FDA approved drug and dosage information(Total Drugs:38) | ||||||||
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DiseaseID | Drug_name | active_ingredients | strength | Dosage Form/Route | Marketing Status | TE code | RLD | RS |
MESH:D013921 | 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:D013921 | 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:D013921 | omeprazole | omeprazole | 20MG | TABLET, DELAYED RELEASE;ORAL | Over-the-counter | None | Yes | Yes |
MESH:D013921 | omeprazole | omeprazole | 20MG | TABLET, DELAYED RELEASE;ORAL | Over-the-counter | None | Yes | Yes |
MESH:D013921 | 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:D013921 | zyvox | linezolid | 200MG/100ML (2MG/ML) | SOLUTION;IV (INFUSION) | Prescription | AP | Yes | No |
MESH:D013921 | zyvox | linezolid | 100MG/5ML | FOR SUSPENSION;ORAL | Prescription | AB | Yes | Yes |
MESH:D013921 | 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:D013921 | zyvox | linezolid | 200MG/100ML (2MG/ML) | SOLUTION;IV (INFUSION) | Prescription | AP | Yes | No |
MESH:D013921 | zyvox | linezolid | 100MG/5ML | FOR SUSPENSION;ORAL | Prescription | AB | Yes | Yes |
MESH:D013921 | busulfex | busulfan | 6MG/ML | INJECTABLE;INJECTION | Prescription | AP | Yes | Yes |
MESH:D013921 | temodar | temozolomide | 5MG | CAPSULE;ORAL | Prescription | AB | Yes | No |
MESH:D013921 | temodar | temozolomide | 100MG/VIAL | POWDER;INTRAVENOUS | Prescription | None | Yes | Yes |
MESH:D013921 | cipro | ciprofloxacin | 400MG/40ML (10MG/ML) | INJECTABLE;INJECTION | Discontinued | None | Yes | No |
MESH:D013921 | cipro | ciprofloxacin | 250MG/5ML | FOR SUSPENSION;ORAL | Prescription | AB | Yes | No |
MESH:D013921 | rapamune | sirolimus | 1MG/ML | SOLUTION;ORAL | Prescription | None | Yes | Yes |
MESH:D013921 | rapamune | sirolimus | 1MG | TABLET;ORAL | Prescription | AB | Yes | No |
MESH:D013921 | 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:D013921 | eloxatin | oxaliplatin | 50MG/10ML (5MG/ML) | INJECTABLE;IV (INFUSION) | Prescription | AP | Yes | Yes |
MESH:D013921 | oxaliplatin | oxaliplatin | 50MG/10ML (5MG/ML) | INJECTABLE;IV (INFUSION) | Prescription | AP | Yes | Yes |
MESH:D013921 | argatroban | argatroban | 250MG/2.5ML (100MG/ML) | INJECTABLE;INJECTION | Prescription | AP | Yes | Yes |
MESH:D013921 | argatroban | argatroban | 250MG/250ML | INJECTABLE; INJECTION | None (Tentative Approval) | None | No | No |
MESH:D013921 | argatroban | argatroban | 250MG/2.5ML (100MG/ML) | INJECTABLE;INJECTION | Prescription | AP | Yes | Yes |
MESH:D013921 | argatroban | argatroban | 250MG/250ML | INJECTABLE; INJECTION | None (Tentative Approval) | None | No | No |
MESH:D013921 | retrovir | zidovudine | 100MG | CAPSULE;ORAL | Prescription | AB | Yes | Yes |
MESH:D013921 | retrovir | zidovudine | 100MG | CAPSULE;ORAL | Prescription | AB | Yes | Yes |
MESH:D013921 | retrovir | zidovudine | 50MG/5ML | SYRUP;ORAL | Prescription | AA | Yes | Yes |
MESH:D013921 | retrovir | zidovudine | 50MG/5ML | SYRUP;ORAL | Prescription | AA | Yes | Yes |
MESH:D013921 | retrovir | zidovudine | 10MG/ML | INJECTABLE;INJECTION | Prescription | AP | Yes | Yes |
MESH:D013921 | retrovir | zidovudine | 10MG/ML | INJECTABLE;INJECTION | Prescription | AP | Yes | Yes |
MESH:D013921 | retrovir | zidovudine | 200MG | TABLET;ORAL | Discontinued | None | No | No |
MESH:D013921 | retrovir | zidovudine | 200MG | TABLET;ORAL | Discontinued | None | No | No |
MESH:D013921 | zidovudine | zidovudine | 60MG | TABLET;ORAL | Discontinued | None | No | No |
MESH:D013921 | zidovudine | zidovudine | 60MG | TABLET;ORAL | Discontinued | None | No | No |
MESH:D013921 | zidovudine | zidovudine | 60MG | TABLET;ORAL | Discontinued | None | No | No |
MESH:D013921 | zidovudine | zidovudine | 60MG | TABLET;ORAL | Discontinued | None | No | No |
MESH:D013921 | afinitor | everolimus | 5MG | TABLET;ORAL | Prescription | None | Yes | No |
MESH:D013921 | velcade | bortezomib | 3.5MG/VIAL | INJECTABLE;INTRAVENOUS, SUBCUTANEOUS | Prescription | None | Yes | Yes |
FDA labeling changes(Total Drugs:38) | |||||||||||||
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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:D013921 | 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:D013921 | 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:D013921 | 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:D013921 | 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:D013921 | 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:D013921 | 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:D013921 | 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:D013921 | 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:D013921 | 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:D013921 | 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:D013921 | 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:D013921 | 11/3/2003 | temodar | temozolomide | Recurrent CNS tumors | Temozolomide effectiveness in children has not been demonstrated New data from 2 open-label Phase 2 studies in pediatric patients 3-18 years of age. In one study there were 29 patients with recurrent brain stem glioma and 34 patients with recurrent high grade astrocyoma. In a second study there were 122 patients enrolled with various types of tumors; 113 CNS tumors and 9 non-CNS tumors. The temozolomide toxicity profile in children is similar to adults | Labeling | B | - | - | - | Schering | 11/20/2002 | FALSE' |
MESH:D013921 | 11/3/2003 | temodar | temozolomide | Recurrent CNS tumors | Temozolomide effectiveness in children has not been demonstrated New data from 2 open-label Phase 2 studies in pediatric patients 3-18 years of age. In one study there were 29 patients with recurrent brain stem glioma and 34 patients with recurrent high grade astrocyoma. In a second study there were 122 patients enrolled with various types of tumors; 113 CNS tumors and 9 non-CNS tumors. The temozolomide toxicity profile in children is similar to adults | Labeling | B | - | - | - | Schering | 11/20/2002 | FALSE' |
MESH:D013921 | 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:D013921 | 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:D013921 | 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:D013921 | 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:D013921 | 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:D013921 | 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:D013921 | 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:D013921 | 5/5/2008 | argatroban | argatroban | Heparin-Induced Thrombocytopenia (HIT) or HIT with Thrombosis | Safety and effectiveness, including the appropriate anticoagulation goals and duration of therapy, have not been established in pediatric patients Population PK/PD analysis of sparse data in 15 seriously ill pediatric patients ages | Labeling | - | - | B, P | - | Encysive | - | FALSE' |
MESH:D013921 | 5/5/2008 | argatroban | argatroban | Heparin-Induced Thrombocytopenia (HIT) or HIT with Thrombosis | Safety and effectiveness, including the appropriate anticoagulation goals and duration of therapy, have not been established in pediatric patients Population PK/PD analysis of sparse data in 15 seriously ill pediatric patients ages | Labeling | - | - | B, P | - | Encysive | - | FALSE' |
MESH:D013921 | 5/5/2008 | argatroban | argatroban | Heparin-Induced Thrombocytopenia (HIT) or HIT with Thrombosis | Safety and effectiveness, including the appropriate anticoagulation goals and duration of therapy, have not been established in pediatric patients Population PK/PD analysis of sparse data in 15 seriously ill pediatric patients ages | Labeling | - | - | B, P | - | Encysive | - | FALSE' |
MESH:D013921 | 5/5/2008 | argatroban | argatroban | Heparin-Induced Thrombocytopenia (HIT) or HIT with Thrombosis | Safety and effectiveness, including the appropriate anticoagulation goals and duration of therapy, have not been established in pediatric patients Population PK/PD analysis of sparse data in 15 seriously ill pediatric patients ages | Labeling | - | - | B, P | - | Encysive | - | FALSE' |
MESH:D013921 | 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:D013921 | 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:D013921 | 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:D013921 | 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:D013921 | 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:D013921 | 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:D013921 | 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:D013921 | 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:D013921 | 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:D013921 | 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:D013921 | 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:D013921 | 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:D013921 | 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:D013921 | 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 |