PedAM
Pediatric Disease Annotations & Medicines
| dystonia | ||||
| Disease ID | 120 |
|---|---|
| Disease | dystonia |
| Manually Symptom | UMLS | Name(Total Manually Symptoms:29) C2712340 | dyspnea C2364114 | tremor C2364072 | depression C1963087 | constipation C1963064 | anxiety C1518715 | homunculus C1439329 | homocystinuria C1334804 | motor manifestations C1096335 | radiculomyelopathy C1096335 | myeloradiculopathy C0575081 | gait disturbance C0426980 | motor symptoms C0342776 | complex i deficiency C0270814 | spastic syndrome C0264162 | camptocormia C0262471 | ent problem C0262405 | cerebral dysfunction C0235169 | excitability C0221163 | motor disorders C0037933 | spinal disease C0035258 | restless legs syndrome C0031117 | peripheral neuropathy C0027765 | neurological disorders C0027765 | neurologic disorder C0027066 | myoclonus C0026650 | movement disorders C0015371 | extrapyramidal syndrome C0013384 | abnormal movements C0001430 | adenoma |
| Text Mined Symptom | UMLS | Name | Sentences' Count(Total Symptoms:10) C0040822 | tremor | 17 C0026650 | movement disorders | 3 C0235169 | excitability | 3 C0426980 | motor symptoms | 2 C0011570 | depression | 2 C0027066 | myoclonus | 2 C0027765 | neurologic disorder | 1 C0027765 | neurological disorders | 1 C0013384 | abnormal movements | 1 C1334804 | motor manifestations | 1 |
Manually Genotype(Total Text Mining Genotypes:0) |
|---|
| (Waiting for update.) |
All Snps(Total Genotypes:4) | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| snpId | pubmedId | geneId | geneSymbol | diseaseId | sourceId | sentence | score | Year | geneSymbol_dbSNP | CHROMOSOME | POS | REF | ALT |
| rs1182 | 19202559 | 1861 | TOR1A | umls:C0013421 | BeFree | We studied the influence of the rs1182 polymorphism of the TOR1A gene on the risk of dystonia spread in two representative cohorts of patients presenting with primary blepharospasm (BSP), one from Italy and the other from the United States of America. | 0.204343442 | 2009 | TOR1A | 9 | 129813781 | C | A |
| rs121434410 | 26231208 | 8575 | PRKRA | umls:C0013421 | BeFree | A recessively inherited form of early-onset dystonia DYT16 has been recently identified to arise due to a homozygous missense mutation P222L in PACT. | 0.125981653 | 2015 | PRKRA;LOC101927027 | 2 | 178436264 | G | A |
| rs121908683 | 19087156 | 8398 | PLA2G6 | umls:C0013421 | BeFree | R632W mutation in PLA2G6 segregates with dystonia-parkinsonism in a consanguineous Iranian family. | 0.002714419 | 2009 | PLA2G6 | 22 | 38115667 | G | A |
| rs121917763 | 10661862 | 7054 | TH | umls:C0013421 | BeFree | The phenotype of AR-DRD with the Leu205Pro mutation in the TH gene, which produces a severe decrease in TH activity to 1.5% of that of the wild type, was severe, not dystonia/Segawa's syndrome, but early-onset parkinsonism. | 0.131973237 | 1999 | TH | 11 | 2167896 | A | G |
GWASdb Annotation(Total Genotypes:0) | |
|---|---|
| (Waiting for update.) | |
GWASdb Snp Trait(Total Genotypes:10) | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 |
| 3 | 54378600 | rs11711956 | A | G | rs11711956 | 24375517 | 2.00E-06 | NA | 1.73 | [1.38-2.18] | 127 European ancestry cases; 984 European ancestry controls | European(1111) | ALL(1111) | EUR(1111) | ALL(1111) | Musician's dystonia | HPOID:0001332 | Dystonia | DOID:543 | dystonia | NA | NA | NA | NA | NA | NA | Research Support, Non-U.S. Gov't | G | CACNA2D3 |
| 5 | 163869843 | rs6556752 | C | T | rs6556752 | 24375517 | 1.32E-04 | NA | 6.6 | [2.51-17.37] | 127 European ancestry cases; 984 European ancestry controls | European(1111) | ALL(1111) | EUR(1111) | ALL(1111) | Musician's dystonia | HPOID:0001332 | Dystonia | DOID:543 | dystonia | NA | NA | NA | NA | NA | NA | Research Support, Non-U.S. Gov't | T | LOC100507193 |
| 7 | 76962868 | rs11983527 | C | G | rs11983527 | 24375517 | 2.91E-04 | NA | 1.5 | [1.20-1.86] | 127 European ancestry cases; 984 European ancestry controls | European(1111) | ALL(1111) | EUR(1111) | ALL(1111) | Musician's dystonia | HPOID:0001332 | Dystonia | DOID:543 | dystonia | NA | NA | NA | NA | NA | NA | Research Support, Non-U.S. Gov't | G | PION |
| 7 | 76968595 | rs11505827 | G | A | rs11505827 | 24375517 | 3.48E-04 | NA | 1.48 | [1.20-1.84] | 127 European ancestry cases; 984 European ancestry controls | European(1111) | ALL(1111) | EUR(1111) | ALL(1111) | Musician's dystonia | HPOID:0001332 | Dystonia | DOID:543 | dystonia | NA | NA | NA | NA | NA | NA | Research Support, Non-U.S. Gov't | A | PION |
| 8 | 26922112 | rs17060993 | T | A | rs17060993 | 24375517 | 2.00E-06 | NA | 2.7 | [1.80-4.06] | 127 European ancestry cases; 984 European ancestry controls | European(1111) | ALL(1111) | EUR(1111) | ALL(1111) | Musician's dystonia | HPOID:0001332 | Dystonia | DOID:543 | dystonia | NA | NA | NA | NA | NA | NA | Research Support, Non-U.S. Gov't | T | NA |
| 10 | 70304269 | rs5030881 | G | A | rs5030881 | 24375517 | 2.56E-04 | NA | 2.78 | [1.61-4.82] | 127 European ancestry cases; 984 European ancestry controls | European(1111) | ALL(1111) | EUR(1111) | ALL(1111) | Musician's dystonia | HPOID:0001332 | Dystonia | DOID:543 | dystonia | NA | NA | NA | NA | NA | NA | Research Support, Non-U.S. Gov't | C | NA |
| 13 | 43111120 | rs7491228 | C | T | rs7491228 | 24375517 | 4.35E-04 | NA | 1.5 | [1.20-1.88] | 127 European ancestry cases; 984 European ancestry controls | European(1111) | ALL(1111) | EUR(1111) | ALL(1111) | Musician's dystonia | HPOID:0001332 | Dystonia | DOID:543 | dystonia | NA | NA | NA | NA | NA | NA | Research Support, Non-U.S. Gov't | C | NA |
| 13 | 43121473 | rs9594780 | A | G | rs9594780 | 24375517 | 1.88E-04 | NA | 1.54 | [1.23-1.93] | 127 European ancestry cases; 984 European ancestry controls | European(1111) | ALL(1111) | EUR(1111) | ALL(1111) | Musician's dystonia | HPOID:0001332 | Dystonia | DOID:543 | dystonia | NA | NA | NA | NA | NA | NA | Research Support, Non-U.S. Gov't | A | NA |
| 14 | 98649816 | rs9323992 | C | T | rs9323992 | 24375517 | 1.31E-05 | NA | 1.67 | [1.33-2.10] | 127 European ancestry cases; 984 European ancestry controls | European(1111) | ALL(1111) | EUR(1111) | ALL(1111) | Musician's dystonia | HPOID:0001332 | Dystonia | DOID:543 | dystonia | NA | NA | NA | NA | NA | NA | Research Support, Non-U.S. Gov't | C | NA |
| 17 | 66382209 | rs11655081 | T | C | rs11655081 | 24375517 | 4.00E-09 | NA | 4.33 | [2.66-7.05] | 127 European ancestry cases; 984 European ancestry controls | European(1111) | ALL(1111) | EUR(1111) | ALL(1111) | Musician's dystonia | HPOID:0001332 | Dystonia | DOID:543 | dystonia | NA | NA | NA | NA | NA | NA | Research Support, Non-U.S. Gov't | C | ARSG |
Mapped by lexical matching(Total Items:1) | ||||
|---|---|---|---|---|
| HP ID | HP Name | MP ID | MP Name | Annotation |
| HP:0002071 | Abnormality of extrapyramidal motor function | MP:0003880 | abnormal central pattern generator function; | |
Mapped by homologous gene(Total Items:1) | ||||
|---|---|---|---|---|
| HP ID | HP Name | MP ID | MP Name | Annotation |
| HP:0002094 | Dyspnea | MP:0005402 | abnormal action potential;HP:0001288 | Gait disturbance |
Chemical(Total Drugs:60) | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| CUI | ChemicalName | ChemicalID | CasRN | DiseaseName | DiseaseID | DirectEvidence | PubMedIDs | ||
| C0013421 | amitriptyline | D000639 | 50-48-6 | dystonia | MESH:D004421 | marker/mechanism | 1602323 | ||
| C0013421 | amoxapine | D000657 | 14028-44-5 | dystonia | MESH:D004421 | marker/mechanism | 6701281 | ||
| C0013421 | amphetamine | D000661 | 300-62-9 | dystonia | MESH:D004421 | marker/mechanism | 7953053 | ||
| C0013421 | aripiprazole | D000068180 | - | dystonia | MESH:D004421 | marker/mechanism | 16569800 | ||
| C0013421 | baclofen | D001418 | 1134-47-0 | dystonia | MESH:D004421 | therapeutic | 18349207 | ||
| C0013421 | buspirone | D002065 | 36505-84-7 | dystonia | MESH:D004421 | marker/mechanism | 8101969 | ||
| C0013421 | carbamazepine | D002220 | 298-46-4 | dystonia | MESH:D004421 | marker/mechanism | 11869747 | ||
| C0013421 | carbamazepine | D002220 | 298-46-4 | dystonia | MESH:D004421 | therapeutic | 1899474 | ||
| C0013421 | cetirizine | D017332 | 83881-51-0 | dystonia | MESH:D004421 | marker/mechanism | 16401869 | ||
| C0013421 | chloroquine | D002738 | 1954/5/7 | dystonia | MESH:D004421 | marker/mechanism | 3371193 | ||
| C0013421 | chlorpromazine | D002746 | 50-53-3 | dystonia | MESH:D004421 | marker/mechanism | 10389620 | ||
| C0013421 | chlorpromazine | D002746 | 50-53-3 | dystonia | MESH:D004421 | therapeutic | 2278124 | ||
| C0013421 | cimetidine | D002927 | 51481-61-9 | dystonia | MESH:D004421 | marker/mechanism | 11399384 | ||
| C0013421 | cisapride | D020117 | 81098-60-4 | dystonia | MESH:D004421 | marker/mechanism | 15506326 | ||
| C0013421 | citalopram | D015283 | 59729-33-8 | dystonia | MESH:D004421 | marker/mechanism | 17414946 | ||
| C0013421 | clozapine | D003024 | 5786-21-0 | dystonia | MESH:D004421 | marker/mechanism | 14754793 | ||
| C0013421 | clozapine | D003024 | 5786-21-0 | dystonia | MESH:D004421 | therapeutic | 9374198 | ||
| C0013421 | codeine | D003061 | 76-57-3 | dystonia | MESH:D004421 | marker/mechanism | 11587381 | ||
| C0013421 | droxidopa | D015103 | 23651-95-8 | dystonia | MESH:D004421 | marker/mechanism | 16277235 | ||
| C0013421 | droperidol | D004329 | 548-73-2 | dystonia | MESH:D004421 | marker/mechanism | 11075569 | ||
| C0013421 | entacapone | C071192 | 116314-67-1 | dystonia | MESH:D004421 | marker/mechanism | 18814889 | ||
| C0013421 | fluoxetine | D005473 | 54910-89-3 | dystonia | MESH:D004421 | marker/mechanism | 11481710 | ||
| C0013421 | fluvoxamine | D016666 | 54739-18-3 | dystonia | MESH:D004421 | marker/mechanism | 10200869 | ||
| C0013421 | foscarnet | D017245 | 4428-95-9 | dystonia | MESH:D004421 | marker/mechanism | 18356641 | ||
| C0013421 | gabapentin | C040029 | 60142-96-3 | dystonia | MESH:D004421 | marker/mechanism | 15644468 | ||
| C0013421 | gabapentin | C040029 | 60142-96-3 | dystonia | MESH:D004421 | therapeutic | 10809949 | ||
| C0013421 | haloperidol | D006220 | 52-86-8 | dystonia | MESH:D004421 | marker/mechanism | 10350027 | ||
| C0013421 | haloperidol | D006220 | 52-86-8 | dystonia | MESH:D004421 | therapeutic | 9374198 | ||
| C0013421 | lamotrigine | C047781 | 84057-84-1 | dystonia | MESH:D004421 | marker/mechanism | 19681008 | ||
| C0013421 | lisuride | D008090 | 18016-80-3 | dystonia | MESH:D004421 | therapeutic | 1350058 | ||
| C0013421 | lorazepam | D008140 | 846-49-1 | dystonia | MESH:D004421 | therapeutic | 18344742 | ||
| C0013421 | loxapine | D008152 | 1977/10/2 | dystonia | MESH:D004421 | marker/mechanism | 16239854 | ||
| C0013421 | dextromethorphan | D003915 | 125-71-3 | dystonia | MESH:D004421 | marker/mechanism | 8667476 | ||
| C0013421 | methylphenidate | D008774 | 113-45-1 | dystonia | MESH:D004421 | marker/mechanism | 15908830 | ||
| C0013421 | methysergide | D008784 | 361-37-5 | dystonia | MESH:D004421 | therapeutic | 3470140 | ||
| C0013421 | midodrine | D008879 | 42794-76-3 | dystonia | MESH:D004421 | marker/mechanism | 11001613 | ||
| C0013421 | mirtazapine | C035133 | - | dystonia | MESH:D004421 | marker/mechanism | 12019672 | ||
| C0013421 | nicotine | D009538 | - | dystonia | MESH:D004421 | marker/mechanism | 19404753 | ||
| C0013421 | norepinephrine | D009638 | 51-41-2 | dystonia | MESH:D004421 | marker/mechanism | 1666503 | ||
| C0013421 | olanzapine | C076029 | 132539-06-1 | dystonia | MESH:D004421 | marker/mechanism | 10518183 | ||
| C0013421 | olanzapine | C076029 | 132539-06-1 | dystonia | MESH:D004421 | therapeutic | 14642376 | ||
| C0013421 | phenylpropanolamine | D010665 | 14838-15-4 | dystonia | MESH:D004421 | marker/mechanism | 7492048 | ||
| C0013421 | phenytoin | D010672 | 57-41-0 | dystonia | MESH:D004421 | marker/mechanism | 1011032 | ||
| C0013421 | pramipexole | C061333 | - | dystonia | MESH:D004421 | marker/mechanism | 19319462 | ||
| C0013421 | prochlorperazine | D011346 | 58-38-8 | dystonia | MESH:D004421 | marker/mechanism | 10579022 | ||
| C0013421 | procyclidine | D011352 | 77-37-2 | dystonia | MESH:D004421 | therapeutic | 12503843 | ||
| C0013421 | propranolol | D011433 | 525-66-6 | dystonia | MESH:D004421 | marker/mechanism | 10768633 | ||
| C0013421 | pyridoxine | D011736 | - | dystonia | MESH:D004421 | therapeutic | 5467095 | ||
| C0013421 | quinine | D011803 | 130-95-0 | dystonia | MESH:D004421 | marker/mechanism | 14697088 | ||
| C0013421 | succinylcholine | D013390 | 306-40-1 | dystonia | MESH:D004421 | therapeutic | 9557916 | ||
| C0013421 | sulpiride | D013469 | 15676-16-1 | dystonia | MESH:D004421 | marker/mechanism | 1742756 | ||
| C0013421 | tetrabenazine | D013747 | 58-46-8 | dystonia | MESH:D004421 | marker/mechanism | 8644096 | ||
| C0013421 | tetrabenazine | D013747 | 58-46-8 | dystonia | MESH:D004421 | therapeutic | 3279337 | ||
| C0013421 | thiethylperazine | D013847 | 1420-55-9 | dystonia | MESH:D004421 | marker/mechanism | 1880525 | ||
| C0013421 | thiopental | D013874 | 76-75-5 | dystonia | MESH:D004421 | therapeutic | 9557916 | ||
| C0013421 | trihexyphenidyl | D014282 | 144-11-6 | dystonia | MESH:D004421 | marker/mechanism | 4144147 | ||
| C0013421 | trihexyphenidyl | D014282 | 144-11-6 | dystonia | MESH:D004421 | therapeutic | 16702617 | ||
| C0013421 | valproic acid | D014635 | 99-66-1 | dystonia | MESH:D004421 | marker/mechanism | 15230719 | ||
| C0013421 | valproic acid | D014635 | 99-66-1 | dystonia | MESH:D004421 | therapeutic | 1851702 | ||
| C0013421 | ziprasidone | C092292 | 146939-27-7 | dystonia | MESH:D004421 | marker/mechanism | 17484950 | ||
FDA approved drug and dosage information(Total Drugs:48) | ||||||||
|---|---|---|---|---|---|---|---|---|
| DiseaseID | Drug_name | active_ingredients | strength | Dosage Form/Route | Marketing Status | TE code | RLD | RS |
| MESH:D004421 | neurontin | gabapentin | 100MG | CAPSULE;ORAL | Prescription | AB | Yes | No |
| MESH:D004421 | neurontin | gabapentin | 100MG | CAPSULE;ORAL | Prescription | AB | Yes | No |
| MESH:D004421 | neurontin | gabapentin | 600MG | TABLET;ORAL | Prescription | AB | Yes | No |
| MESH:D004421 | neurontin | gabapentin | 600MG | TABLET;ORAL | Prescription | AB | Yes | No |
| MESH:D004421 | neurontin | gabapentin | 250MG/5ML | SOLUTION;ORAL | Prescription | AA | Yes | Yes |
| MESH:D004421 | neurontin | gabapentin | 250MG/5ML | SOLUTION;ORAL | Prescription | AA | Yes | Yes |
| MESH:D004421 | neurontin | gabapentin | 0 | SOLUTION; ORAL | Prescription | None | No | No |
| MESH:D004421 | neurontin | gabapentin | 0 | SOLUTION; ORAL | Prescription | None | No | No |
| MESH:D004421 | neurontin | gabapentin | 600MG | TABLET; ORAL | Prescription | None | No | No |
| MESH:D004421 | neurontin | gabapentin | 600MG | TABLET; ORAL | Prescription | None | No | No |
| MESH:D004421 | neurontin | gabapentin | 800MG | CAPSULE; ORAL | Prescription | None | No | No |
| MESH:D004421 | neurontin | gabapentin | 800MG | CAPSULE; ORAL | Prescription | None | No | No |
| MESH:D004421 | neurontin | gabapentin | 250MG/5ML | SOLUTION; ORAL | Prescription | None | No | No |
| MESH:D004421 | neurontin | gabapentin | 250MG/5ML | SOLUTION; ORAL | Prescription | None | No | No |
| MESH:D004421 | lamictal | lamotrigine | 100MG | TABLET;ORAL | Prescription | AB | Yes | No |
| MESH:D004421 | lamictal | lamotrigine | 100MG | TABLET;ORAL | Prescription | AB | Yes | No |
| MESH:D004421 | lamictal | lamotrigine | 100MG | TABLET;ORAL | Prescription | AB | Yes | No |
| MESH:D004421 | lamictal xr | lamotrigine | 25MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB | Yes | No |
| MESH:D004421 | lamictal xr | lamotrigine | 25MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB | Yes | No |
| MESH:D004421 | lamictal xr | lamotrigine | 25MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB | Yes | No |
| MESH:D004421 | remeron | mirtazapine | 15MG | TABLET;ORAL | Prescription | AB | Yes | Yes |
| MESH:D004421 | daytrana | methylphenidate | 10MG/9HR (1.1MG/HR) | FILM, EXTENDED RELEASE;TRANSDERMAL | Prescription | None | Yes | No |
| MESH:D004421 | daytrana | methylphenidate | 10MG/9HR (1.1MG/HR) | FILM, EXTENDED RELEASE;TRANSDERMAL | Prescription | None | Yes | No |
| MESH:D004421 | daytrana | methylphenidate | 10MG/9HR (1.1MG/HR) | FILM, EXTENDED RELEASE;TRANSDERMAL | Prescription | None | Yes | No |
| MESH:D004421 | abilify | aripiprazole | 10MG | TABLET;ORAL | Prescription | AB | Yes | Yes |
| MESH:D004421 | abilify | aripiprazole | 1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons | SOLUTION;ORAL | Discontinued | None | Yes | No |
| MESH:D004421 | abilify | aripiprazole | 10MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons | TABLET, ORALLY DISINTEGRATING;ORAL | Discontinued | None | No | No |
| MESH:D004421 | abilify | aripiprazole | 9.75MG/1.3ML (7.5MG/ML) | INJECTABLE;INTRAMUSCULAR | Discontinued | None | No | No |
| MESH:D004421 | abilify | aripiprazole | 10MG | TABLET;ORAL | Prescription | AB | Yes | Yes |
| MESH:D004421 | abilify | aripiprazole | 1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons | SOLUTION;ORAL | Discontinued | None | Yes | No |
| MESH:D004421 | abilify | aripiprazole | 10MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons | TABLET, ORALLY DISINTEGRATING;ORAL | Discontinued | None | No | No |
| MESH:D004421 | abilify | aripiprazole | 9.75MG/1.3ML (7.5MG/ML) | INJECTABLE;INTRAMUSCULAR | Discontinued | None | No | No |
| MESH:D004421 | abilify | aripiprazole | 10MG | TABLET;ORAL | Prescription | AB | Yes | Yes |
| MESH:D004421 | abilify | aripiprazole | 1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons | SOLUTION;ORAL | Discontinued | None | Yes | No |
| MESH:D004421 | abilify | aripiprazole | 10MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons | TABLET, ORALLY DISINTEGRATING;ORAL | Discontinued | None | No | No |
| MESH:D004421 | abilify | aripiprazole | 9.75MG/1.3ML (7.5MG/ML) | INJECTABLE;INTRAMUSCULAR | Discontinued | None | No | No |
| MESH:D004421 | abilify | aripiprazole | 10MG | TABLET;ORAL | Prescription | AB | Yes | Yes |
| MESH:D004421 | abilify | aripiprazole | 1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons | SOLUTION;ORAL | Discontinued | None | Yes | No |
| MESH:D004421 | abilify | aripiprazole | 10MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons | TABLET, ORALLY DISINTEGRATING;ORAL | Discontinued | None | No | No |
| MESH:D004421 | abilify | aripiprazole | 9.75MG/1.3ML (7.5MG/ML) | INJECTABLE;INTRAMUSCULAR | Discontinued | None | No | No |
| MESH:D004421 | zyprexa | olanzapine | 2.5MG | TABLET;ORAL | Prescription | AB | Yes | No |
| MESH:D004421 | zyprexa | olanzapine | 2.5MG | TABLET;ORAL | Prescription | AB | Yes | No |
| MESH:D004421 | zyprexa | olanzapine | 10MG/VIAL | INJECTABLE;INTRAMUSCULAR | Prescription | AP | Yes | Yes |
| MESH:D004421 | zyprexa | olanzapine | 10MG/VIAL | INJECTABLE;INTRAMUSCULAR | Prescription | AP | Yes | Yes |
| MESH:D004421 | zyprexa | olanzapine | 2.5MG | TABLET;ORAL | Prescription | AB | Yes | No |
| MESH:D004421 | zyprexa | olanzapine | 2.5MG | TABLET;ORAL | Prescription | AB | Yes | No |
| MESH:D004421 | zyprexa | olanzapine | 10MG/VIAL | INJECTABLE;INTRAMUSCULAR | Prescription | AP | Yes | Yes |
| MESH:D004421 | zyprexa | olanzapine | 10MG/VIAL | INJECTABLE;INTRAMUSCULAR | Prescription | AP | Yes | Yes |
FDA labeling changes(Total Drugs:48) | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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:D004421 | 12/10/2000 | neurontin | gabapentin | Adjunctive therapy in the treatment of partial seizures | Safety and effectiveness established down to 3 years Neuropsychiatric AE's identified in 3-12 year olds Oral clearance normalized per body weight increased in children | Labeling | B | - | - | - | Parke-Davis | 2/2/2000 | FALSE' |
| MESH:D004421 | 12/10/2000 | neurontin | gabapentin | Adjunctive therapy in the treatment of partial seizures | Safety and effectiveness established down to 3 years Neuropsychiatric AE's identified in 3-12 year olds Oral clearance normalized per body weight increased in children | Labeling | B | - | - | - | Parke-Davis | 2/2/2000 | FALSE' |
| MESH:D004421 | 12/10/2000 | neurontin | gabapentin | Adjunctive therapy in the treatment of partial seizures | Safety and effectiveness established down to 3 years Neuropsychiatric AE's identified in 3-12 year olds Oral clearance normalized per body weight increased in children | Labeling | B | - | - | - | Parke-Davis | 2/2/2000 | FALSE' |
| MESH:D004421 | 12/10/2000 | neurontin | gabapentin | Adjunctive therapy in the treatment of partial seizures | Safety and effectiveness established down to 3 years Neuropsychiatric AE's identified in 3-12 year olds Oral clearance normalized per body weight increased in children | Labeling | B | - | - | - | Parke-Davis | 2/2/2000 | FALSE' |
| MESH:D004421 | 12/10/2000 | neurontin | gabapentin | Adjunctive therapy in the treatment of partial seizures | Safety and effectiveness established down to 3 years Neuropsychiatric AE's identified in 3-12 year olds Oral clearance normalized per body weight increased in children | Labeling | B | - | - | - | Parke-Davis | 2/2/2000 | FALSE' |
| MESH:D004421 | 12/10/2000 | neurontin | gabapentin | Adjunctive therapy in the treatment of partial seizures | Safety and effectiveness established down to 3 years Neuropsychiatric AE's identified in 3-12 year olds Oral clearance normalized per body weight increased in children | Labeling | B | - | - | - | Parke-Davis | 2/2/2000 | FALSE' |
| MESH:D004421 | 12/10/2000 | neurontin | gabapentin | Adjunctive therapy in the treatment of partial seizures | Safety and effectiveness established down to 3 years Neuropsychiatric AE's identified in 3-12 year olds Oral clearance normalized per body weight increased in children | Labeling | B | - | - | - | Parke-Davis | 2/2/2000 | FALSE' |
| MESH:D004421 | 12/10/2000 | neurontin | gabapentin | Adjunctive therapy in the treatment of partial seizures | Safety and effectiveness established down to 3 years Neuropsychiatric AE's identified in 3-12 year olds Oral clearance normalized per body weight increased in children | Labeling | B | - | - | - | Parke-Davis | 2/2/2000 | FALSE' |
| MESH:D004421 | 12/10/2000 | neurontin | gabapentin | Adjunctive therapy in the treatment of partial seizures | Safety and effectiveness established down to 3 years Neuropsychiatric AE's identified in 3-12 year olds Oral clearance normalized per body weight increased in children | Labeling | B | - | - | - | Parke-Davis | 2/2/2000 | FALSE' |
| MESH:D004421 | 12/10/2000 | neurontin | gabapentin | Adjunctive therapy in the treatment of partial seizures | Safety and effectiveness established down to 3 years Neuropsychiatric AE's identified in 3-12 year olds Oral clearance normalized per body weight increased in children | Labeling | B | - | - | - | Parke-Davis | 2/2/2000 | FALSE' |
| MESH:D004421 | 12/10/2000 | neurontin | gabapentin | Adjunctive therapy in the treatment of partial seizures | Safety and effectiveness established down to 3 years Neuropsychiatric AE's identified in 3-12 year olds Oral clearance normalized per body weight increased in children | Labeling | B | - | - | - | Parke-Davis | 2/2/2000 | FALSE' |
| MESH:D004421 | 12/10/2000 | neurontin | gabapentin | Adjunctive therapy in the treatment of partial seizures | Safety and effectiveness established down to 3 years Neuropsychiatric AE's identified in 3-12 year olds Oral clearance normalized per body weight increased in children | Labeling | B | - | - | - | Parke-Davis | 2/2/2000 | FALSE' |
| MESH:D004421 | 12/10/2000 | neurontin | gabapentin | Adjunctive therapy in the treatment of partial seizures | Safety and effectiveness established down to 3 years Neuropsychiatric AE's identified in 3-12 year olds Oral clearance normalized per body weight increased in children | Labeling | B | - | - | - | Parke-Davis | 2/2/2000 | FALSE' |
| MESH:D004421 | 12/10/2000 | neurontin | gabapentin | Adjunctive therapy in the treatment of partial seizures | Safety and effectiveness established down to 3 years Neuropsychiatric AE's identified in 3-12 year olds Oral clearance normalized per body weight increased in children | Labeling | B | - | - | - | Parke-Davis | 2/2/2000 | FALSE' |
| MESH:D004421 | 01/17/2003 | lamictal | lamotrigine | Adjunctive therapy for partial seizures | Extended indication from adults to pediatric patients e 2 years Patients aged 2 - 18 years had clearance influenced predominantly by total body weight and concurrent antiepileptic drug (AED) therapy. The oral clearance was higher, on a body weight basis, in pediatric patients than in adults Because of increased clearance in pediatrics, maintenance doses in patients weighing < 30 kg may need an increase of as much as 50% based upon clinical response Evidence shows that the inclusion of VPA in a multi-drug regimen increases the risk of serious, potentially life-threatening rash in pediatric patients Approximately 11.5% of the 1,081 pediatric patients who received the drug as adjunctive therapy in clinical trials discontinued treatment because of an AE | Labeling | B | - | - | - | GlaxoSmithKline | 02/14/2007 | FALSE' |
| MESH:D004421 | 8/5/2009 | lamictal | lamotrigine | Adjunctive treatment for partial seizures in pediatric patients 1 24 months | Safety and effectiveness as adjunctive treatment for partial seizures were not demonstrated in a small randomized, double-blind, placebo-controlled, withdrawal study in pediatric patients 1 - 24 months Immediate release tablets were associated with an increased risk for infectious adverse reactions including bronchiolitis, bronchitis, ear infection, eye infection, otitis externa, pharyngitis, urinary tract infection, and viral infection (Lamictal 37%, Placebo 5%), and respiratory adverse reactions including nasal congestion, cough, and apnea. (Lamictal 26%, Placebo 5%) | Labeling | B | - | - | - | GlaxoSmithKline | 02/14/2007 | FALSE' |
| MESH:D004421 | 05/18/2015 | lamictal | lamotrigine | Maintenance treatment of bipolar disorder | Safety and efficacy for the maintenance treatment of bipolar disorder were not established in a double-blind, placebo-controlled trial that evaluated 301 pediatric patients aged 10 to 17 Information on clinical trial and adverse reactions Postmarketing study | Labeling | - | P | - | - | GlaxoSmithKline | - | FALSE |
| MESH:D004421 | 05/29/2009 | lamictal xr | lamotrigine | Adjunctive therapy for partial onset seizures in patients e13 years of age | Extended release tablets are indicated as adjunctive therapy for partial onset seizures with or without secondary generalization in patients e13 years Safety and effectiveness of extended release tablets for any use in patients below the age of 13 have not been established Information on adverse event profile, and clinical studies New dosage form | Labeling | - | P | - | - | GlaxoSmithKline | - | FALSE' |
| MESH:D004421 | 01/29/2010 | lamictal xr | lamotrigine | Adjunctive therapy for Primary Generalized Tonic-Clonic seizures | New indication for adjunctive therapy for primary generalized tonic-clonic seizures in patients e 13 years of age Safety and effectiveness for any use in patients < 13 years have not been established Information on dosing, adverse reactions, and clinical studies | Labeling | - | P | - | - | GlaxoSmithKline | - | FALSE' |
| MESH:D004421 | 04/25/2011 | lamictal xr | lamotrigine | Monotherapy in patients 13 years of age and older with partial seizures who are receiving therapy with a single antiepileptic drug (AED) | Approved for conversion to monotherapy in patients e13 years of age with partial seizures receiving treatment with a single antiepileptic drug (AED).Safety and effectiveness have not been established (1) as initial monotherapy or (2) for simultaneous conversion to monotherapy from two or more concomitant AEDsInformation on conversion to monotherapy, adverse reactions, clinical trialNew indication | Labeling | - | P | - | - | GlaxoSmithKline | - | FALSE' |
| MESH:D004421 | 12/1/2005 | remeron | mirtazapine | Major Depressive Disorder | Safety and effectiveness in the pediatric population have not been established FDA required boxed warning for all antidepressants: Suicidality in Children and Adolescents - Antidepressants increased the risk of suicidal thinking and behavior (suicidality) in short-term studies in children and adolescents with Major Depressive Disorder (MDD) and other psychiatric disorders. Anyone considering the use of Remeron or any other antidepressant in a child or adolescent must balance this risk with the clinical need. Patients who are started on therapy should be observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Remeron is not approved for use in pediatric patients. (See Warnings and Precautions: Pediatric Use) Pooled analyses of short-term (4 to 16 weeks) placebo-controlled trials of 9 antidepressant drugs (SSRIs and others) in children and adolescents with major depressive disorder (MDD), obsessive compulsive disorder (OCD), or other psychiatric disorders (a total of 24 trials involving over 4400 patients) have revealed a greater risk of adverse events representing suicidal thinking or behavior (suicidality) during the first few months of treatment in those receiving antidepressants. The average risk of such events in patients receiving antidepressants was 4%, twice the placebo risk of 2%. No suicides occurred in these trials Two placebo-controlled trials in 258 pediatric patients with MDD have been conducted with Remeron and the data were not sufficient to support a claim for use in pediatric patients | Labeling | B | - | - | - | Organon | - | FALSE' |
| MESH:D004421 | 6/4/2006 | daytrana | methylphenidate | ADHD | Summary is pending | Labeling | - | P | - | - | Shire | - | FALSE' |
| MESH:D004421 | 12/14/2009 | daytrana | methylphenidate | Postmarketing safety study | Information added to Warnings and Adverse Reactions on skin reactions observed in a postmarketing dermal study in pediatric patients | Labeling | - | P | - | - | Shire | - | FALSE' |
| MESH:D004421 | 06/29/2010 | daytrana | methylphenidate | ADHD | Expanded pediatric indication to include adolescent patients ages13-17 years The most commonly reported adverse reactions in a trial in patients 13-17 years included appetite decreased, nausea, insomnia, weight decreased, dizziness, abdominal pain, and anorexia. The majority of patients had erythema at the application site Information on PK parameters, Adverse Event profile and clinical studies | Labeling | - | P | - | - | Shire | - | FALSE' |
| MESH:D004421 | 10/29/2007 | abilify | aripiprazole | Schizophrenia | Extended schizophrenia indication from adults to adolescents 1317 years Safety and effectiveness in pediatric patients with bipolar mania or agitation associated with schizophrenia or bipolar mania have not been established Efficacy for the maintenance treatment of schizophrenia in the pediatric population has not been evaluated In 6-week placebo controlled efficacy trial in patients 13 17 years with Schizophrenia 30 mg/day was not shown to be more efficacious than 10 mg/day Common adverse events observed were extrapyramidal disorder, somnolence, and tremor; these 3 AEs appear to have a possible dose response relationship Information on dose, AEs, clinical studies | Labeling | B | - | - | - | Otsuka | 11/14/2007 | FALSE' |
| MESH:D004421 | 10/29/2007 | abilify | aripiprazole | Schizophrenia | Extended schizophrenia indication from adults to adolescents 1317 years Safety and effectiveness in pediatric patients with bipolar mania or agitation associated with schizophrenia or bipolar mania have not been established Efficacy for the maintenance treatment of schizophrenia in the pediatric population has not been evaluated In 6-week placebo controlled efficacy trial in patients 13 17 years with Schizophrenia 30 mg/day was not shown to be more efficacious than 10 mg/day Common adverse events observed were extrapyramidal disorder, somnolence, and tremor; these 3 AEs appear to have a possible dose response relationship Information on dose, AEs, clinical studies | Labeling | B | - | - | - | Otsuka | 11/14/2007 | FALSE' |
| MESH:D004421 | 10/29/2007 | abilify | aripiprazole | Schizophrenia | Extended schizophrenia indication from adults to adolescents 1317 years Safety and effectiveness in pediatric patients with bipolar mania or agitation associated with schizophrenia or bipolar mania have not been established Efficacy for the maintenance treatment of schizophrenia in the pediatric population has not been evaluated In 6-week placebo controlled efficacy trial in patients 13 17 years with Schizophrenia 30 mg/day was not shown to be more efficacious than 10 mg/day Common adverse events observed were extrapyramidal disorder, somnolence, and tremor; these 3 AEs appear to have a possible dose response relationship Information on dose, AEs, clinical studies | Labeling | B | - | - | - | Otsuka | 11/14/2007 | FALSE' |
| MESH:D004421 | 10/29/2007 | abilify | aripiprazole | Schizophrenia | Extended schizophrenia indication from adults to adolescents 1317 years Safety and effectiveness in pediatric patients with bipolar mania or agitation associated with schizophrenia or bipolar mania have not been established Efficacy for the maintenance treatment of schizophrenia in the pediatric population has not been evaluated In 6-week placebo controlled efficacy trial in patients 13 17 years with Schizophrenia 30 mg/day was not shown to be more efficacious than 10 mg/day Common adverse events observed were extrapyramidal disorder, somnolence, and tremor; these 3 AEs appear to have a possible dose response relationship Information on dose, AEs, clinical studies | Labeling | B | - | - | - | Otsuka | 11/14/2007 | FALSE' |
| MESH:D004421 | 02/27/2008 | abilify | aripiprazole | Bipolar I Disorder | Extended treatment of acute Bipolar Disorder indication from adults to pediatrics 1017 years The efficacy for the maintenance treatment of Bipolar Disorder in the pediatric population has not been evaluated The recommended target dose in Bipolar Disorder is 10 mg/day. In the study of pediatric patients 10 17 years with Bipolar Mania, 4 common adverse reactions had a possible dose response relationship at 4 weeks; extrapyramidal disorder, somnolence, akathisia and salivary hypersecretion Information on dose, AEs, clinical studies | Labeling | - | - | B, P | - | Otsuka | 11/14/2007 | FALSE' |
| MESH:D004421 | 02/27/2008 | abilify | aripiprazole | Bipolar I Disorder | Extended treatment of acute Bipolar Disorder indication from adults to pediatrics 1017 years The efficacy for the maintenance treatment of Bipolar Disorder in the pediatric population has not been evaluated The recommended target dose in Bipolar Disorder is 10 mg/day. In the study of pediatric patients 10 17 years with Bipolar Mania, 4 common adverse reactions had a possible dose response relationship at 4 weeks; extrapyramidal disorder, somnolence, akathisia and salivary hypersecretion Information on dose, AEs, clinical studies | Labeling | - | - | B, P | - | Otsuka | 11/14/2007 | FALSE' |
| MESH:D004421 | 02/27/2008 | abilify | aripiprazole | Bipolar I Disorder | Extended treatment of acute Bipolar Disorder indication from adults to pediatrics 1017 years The efficacy for the maintenance treatment of Bipolar Disorder in the pediatric population has not been evaluated The recommended target dose in Bipolar Disorder is 10 mg/day. In the study of pediatric patients 10 17 years with Bipolar Mania, 4 common adverse reactions had a possible dose response relationship at 4 weeks; extrapyramidal disorder, somnolence, akathisia and salivary hypersecretion Information on dose, AEs, clinical studies | Labeling | - | - | B, P | - | Otsuka | 11/14/2007 | FALSE' |
| MESH:D004421 | 02/27/2008 | abilify | aripiprazole | Bipolar I Disorder | Extended treatment of acute Bipolar Disorder indication from adults to pediatrics 1017 years The efficacy for the maintenance treatment of Bipolar Disorder in the pediatric population has not been evaluated The recommended target dose in Bipolar Disorder is 10 mg/day. In the study of pediatric patients 10 17 years with Bipolar Mania, 4 common adverse reactions had a possible dose response relationship at 4 weeks; extrapyramidal disorder, somnolence, akathisia and salivary hypersecretion Information on dose, AEs, clinical studies | Labeling | - | - | B, P | - | Otsuka | 11/14/2007 | FALSE' |
| MESH:D004421 | 11/19/2009 | abilify | aripiprazole | Irritability associated with autistic disorder | Safety and effectiveness in pediatric patients demonstrating irritability associated with autistic disorder were established in two placebo-controlled clinical trials in pediatric patients 6 - 17 years of age Most common adverse reactions observed in pediatric clinical trials in patients with autistic disorder included sedation, fatigue, vomiting, somnolence, tremor, pyrexia, drooling, decreased appetite, salivary hypersecretion, extrapyramidal disorder, and lethargy. Fatigue was a possible dose-response adverse reaction. Information on dosing, adverse reactions, and clinical studies | Labeling | - | P | - | - | Otsuka | - | FALSE' |
| MESH:D004421 | 11/19/2009 | abilify | aripiprazole | Irritability associated with autistic disorder | Safety and effectiveness in pediatric patients demonstrating irritability associated with autistic disorder were established in two placebo-controlled clinical trials in pediatric patients 6 - 17 years of age Most common adverse reactions observed in pediatric clinical trials in patients with autistic disorder included sedation, fatigue, vomiting, somnolence, tremor, pyrexia, drooling, decreased appetite, salivary hypersecretion, extrapyramidal disorder, and lethargy. Fatigue was a possible dose-response adverse reaction. Information on dosing, adverse reactions, and clinical studies | Labeling | - | P | - | - | Otsuka | - | FALSE' |
| MESH:D004421 | 11/19/2009 | abilify | aripiprazole | Irritability associated with autistic disorder | Safety and effectiveness in pediatric patients demonstrating irritability associated with autistic disorder were established in two placebo-controlled clinical trials in pediatric patients 6 - 17 years of age Most common adverse reactions observed in pediatric clinical trials in patients with autistic disorder included sedation, fatigue, vomiting, somnolence, tremor, pyrexia, drooling, decreased appetite, salivary hypersecretion, extrapyramidal disorder, and lethargy. Fatigue was a possible dose-response adverse reaction. Information on dosing, adverse reactions, and clinical studies | Labeling | - | P | - | - | Otsuka | - | FALSE' |
| MESH:D004421 | 11/19/2009 | abilify | aripiprazole | Irritability associated with autistic disorder | Safety and effectiveness in pediatric patients demonstrating irritability associated with autistic disorder were established in two placebo-controlled clinical trials in pediatric patients 6 - 17 years of age Most common adverse reactions observed in pediatric clinical trials in patients with autistic disorder included sedation, fatigue, vomiting, somnolence, tremor, pyrexia, drooling, decreased appetite, salivary hypersecretion, extrapyramidal disorder, and lethargy. Fatigue was a possible dose-response adverse reaction. Information on dosing, adverse reactions, and clinical studies | Labeling | - | P | - | - | Otsuka | - | FALSE' |
| MESH:D004421 | 9/6/2014 | abilify | aripiprazole | Maintenance treatment of irritability associated with autistic disorder | Efficacy for the maintenance treatment of irritability associated with autistic disorder was not established in a 12 week clinical trial in 85 pediatric patients 6-17 years Information on clinical trialPostmarketing study | Labeling | - | P | - | - | Otsuka | - | FALSE' |
| MESH:D004421 | 9/6/2014 | abilify | aripiprazole | Maintenance treatment of irritability associated with autistic disorder | Efficacy for the maintenance treatment of irritability associated with autistic disorder was not established in a 12 week clinical trial in 85 pediatric patients 6-17 years Information on clinical trialPostmarketing study | Labeling | - | P | - | - | Otsuka | - | FALSE' |
| MESH:D004421 | 9/6/2014 | abilify | aripiprazole | Maintenance treatment of irritability associated with autistic disorder | Efficacy for the maintenance treatment of irritability associated with autistic disorder was not established in a 12 week clinical trial in 85 pediatric patients 6-17 years Information on clinical trialPostmarketing study | Labeling | - | P | - | - | Otsuka | - | FALSE' |
| MESH:D004421 | 9/6/2014 | abilify | aripiprazole | Maintenance treatment of irritability associated with autistic disorder | Efficacy for the maintenance treatment of irritability associated with autistic disorder was not established in a 12 week clinical trial in 85 pediatric patients 6-17 years Information on clinical trialPostmarketing study | Labeling | - | P | - | - | Otsuka | - | FALSE' |
| MESH:D004421 | 08/14/2008 | zyprexa | olanzapine | schizophrenia; bipolar disorder | Safety and effectiveness have not been established for patients less than 18 years of age In an analysis of placebo-controlled olanzapine monotherapy studies of adolescent patients, including those with schizophrenia or bipolar disorder, olanzapine was associated with: oHyperglycemia - a statistically significantly greater mean change in fasting glucose levels compared to placebo oHyperlipidemia statistically significant increases compared to placebo in fasting triglycerides, fasting total cholesterol and fasting LDL cholesterol oWeight gain olanzapine treated patients gained an average of 4.6 kg, compared to an average of 0.3 kg in placebo-treated patients with a median exposure of 3 weeks; Average weight gain during long-term therapy was 7.4 kg | - | B | - | - | - | Lilly | 10/1/2007 | FALSE' |
| MESH:D004421 | 08/14/2008 | zyprexa | olanzapine | schizophrenia; bipolar disorder | Safety and effectiveness have not been established for patients less than 18 years of age In an analysis of placebo-controlled olanzapine monotherapy studies of adolescent patients, including those with schizophrenia or bipolar disorder, olanzapine was associated with: oHyperglycemia - a statistically significantly greater mean change in fasting glucose levels compared to placebo oHyperlipidemia statistically significant increases compared to placebo in fasting triglycerides, fasting total cholesterol and fasting LDL cholesterol oWeight gain olanzapine treated patients gained an average of 4.6 kg, compared to an average of 0.3 kg in placebo-treated patients with a median exposure of 3 weeks; Average weight gain during long-term therapy was 7.4 kg | - | B | - | - | - | Lilly | 10/1/2007 | FALSE' |
| MESH:D004421 | 08/14/2008 | zyprexa | olanzapine | schizophrenia; bipolar disorder | Safety and effectiveness have not been established for patients less than 18 years of age In an analysis of placebo-controlled olanzapine monotherapy studies of adolescent patients, including those with schizophrenia or bipolar disorder, olanzapine was associated with: oHyperglycemia - a statistically significantly greater mean change in fasting glucose levels compared to placebo oHyperlipidemia statistically significant increases compared to placebo in fasting triglycerides, fasting total cholesterol and fasting LDL cholesterol oWeight gain olanzapine treated patients gained an average of 4.6 kg, compared to an average of 0.3 kg in placebo-treated patients with a median exposure of 3 weeks; Average weight gain during long-term therapy was 7.4 kg | - | B | - | - | - | Lilly | 10/1/2007 | FALSE' |
| MESH:D004421 | 08/14/2008 | zyprexa | olanzapine | schizophrenia; bipolar disorder | Safety and effectiveness have not been established for patients less than 18 years of age In an analysis of placebo-controlled olanzapine monotherapy studies of adolescent patients, including those with schizophrenia or bipolar disorder, olanzapine was associated with: oHyperglycemia - a statistically significantly greater mean change in fasting glucose levels compared to placebo oHyperlipidemia statistically significant increases compared to placebo in fasting triglycerides, fasting total cholesterol and fasting LDL cholesterol oWeight gain olanzapine treated patients gained an average of 4.6 kg, compared to an average of 0.3 kg in placebo-treated patients with a median exposure of 3 weeks; Average weight gain during long-term therapy was 7.4 kg | - | B | - | - | - | Lilly | 10/1/2007 | FALSE' |
| MESH:D004421 | 4/12/2009 | zyprexa | olanzapine | Treatment of manic or mixed episodes of bipolar I disorder and schizophrenia in adolescents ages 13-17 | Extended schizophrenia and manic or mixed episodes of bipolar I disorder indications from adults to adolescents 1317 years of age Safety and effectiveness in children < 13 years of age have not been established Recommended starting dose for adolescents is lower than that for adults Compared to patients from adult clinical trials, adolescents were likely to gain more weight, experience increased sedation, and have greater increases in total cholesterol, triglycerides, LDL cholesterol, prolactin and hepatic transaminase levels Information on dosing, adverse reactions, pharmacokinetics, clinical studies | Labeling | B | - | - | - | Lilly | 10/1/2007 | TRUE' |
| MESH:D004421 | 4/12/2009 | zyprexa | olanzapine | Treatment of manic or mixed episodes of bipolar I disorder and schizophrenia in adolescents ages 13-17 | Extended schizophrenia and manic or mixed episodes of bipolar I disorder indications from adults to adolescents 1317 years of age Safety and effectiveness in children < 13 years of age have not been established Recommended starting dose for adolescents is lower than that for adults Compared to patients from adult clinical trials, adolescents were likely to gain more weight, experience increased sedation, and have greater increases in total cholesterol, triglycerides, LDL cholesterol, prolactin and hepatic transaminase levels Information on dosing, adverse reactions, pharmacokinetics, clinical studies | Labeling | B | - | - | - | Lilly | 10/1/2007 | TRUE' |
| MESH:D004421 | 4/12/2009 | zyprexa | olanzapine | Treatment of manic or mixed episodes of bipolar I disorder and schizophrenia in adolescents ages 13-17 | Extended schizophrenia and manic or mixed episodes of bipolar I disorder indications from adults to adolescents 1317 years of age Safety and effectiveness in children < 13 years of age have not been established Recommended starting dose for adolescents is lower than that for adults Compared to patients from adult clinical trials, adolescents were likely to gain more weight, experience increased sedation, and have greater increases in total cholesterol, triglycerides, LDL cholesterol, prolactin and hepatic transaminase levels Information on dosing, adverse reactions, pharmacokinetics, clinical studies | Labeling | B | - | - | - | Lilly | 10/1/2007 | TRUE' |
| MESH:D004421 | 4/12/2009 | zyprexa | olanzapine | Treatment of manic or mixed episodes of bipolar I disorder and schizophrenia in adolescents ages 13-17 | Extended schizophrenia and manic or mixed episodes of bipolar I disorder indications from adults to adolescents 1317 years of age Safety and effectiveness in children < 13 years of age have not been established Recommended starting dose for adolescents is lower than that for adults Compared to patients from adult clinical trials, adolescents were likely to gain more weight, experience increased sedation, and have greater increases in total cholesterol, triglycerides, LDL cholesterol, prolactin and hepatic transaminase levels Information on dosing, adverse reactions, pharmacokinetics, clinical studies | Labeling | B | - | - | - | Lilly | 10/1/2007 | TRUE' |