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Pediatric Disease Annotations & Medicines



   tremor
  

Disease ID 521
Disease tremor
Definition
Cyclical movement of a body part that can represent either a physiologic process or a manifestation of disease. Intention or action tremor, a common manifestation of CEREBELLAR DISEASES, is aggravated by movement. In contrast, resting tremor is maximal when there is no attempt at voluntary movement, and occurs as a relatively frequent manifestation of PARKINSON DISEASE.
Synonym
(has a tremor) or (tremor symptom) or (shaking)
(has a tremor) or (tremor symptom) or (shaking) (finding)
[d]tremor
[d]tremor (context-dependent category)
[d]tremor (situation)
[d]tremor nos
[d]tremor nos (context-dependent category)
[d]tremor nos (situation)
d tremors
has a tremor
quiver
quivering
quivers
shake
shakes
shaking
shaking all over
shaking/tremors
the shakes
tremor (finding)
tremor [d]
tremor [d] (finding)
tremor [d] (situation)
tremor [disease/finding]
tremor nos
tremor symptom
tremor, nos
tremors
tremors/shaking
UMLS
C0040822
MeSH
SNOMED-CT
Comorbidity
UMLS | Disease | Sentences' Count(Total Sentences:70)
C0030567  |  parkinson's disease  |  41
C0270736  |  essential tremor  |  29
C0013421  |  dystonia  |  17
C0004134  |  ataxia  |  15
C0026769  |  multiple sclerosis  |  11
C0014544  |  epilepsy  |  9
C0949445  |  cervical dystonia  |  8
C0030567  |  parkinson disease  |  8
C0497327  |  dementia  |  4
C0007758  |  cerebellar ataxia  |  4
C0003467  |  anxiety  |  3
C0031117  |  peripheral neuropathy  |  3
C0007760  |  cerebellar dysfunction  |  2
C0028738  |  nystagmus  |  2
C0018213  |  graves' disease  |  2
C0007959  |  charcot-marie-tooth disease  |  2
C0022735  |  klinefelter syndrome  |  2
C0152025  |  polyneuropathy  |  2
C0206083  |  central pontine myelinolysis  |  2
C0679466  |  cognitive deficits  |  2
C0023890  |  liver cirrhosis  |  1
C0027765  |  neurological disorder  |  1
C0035435  |  rheumatic disease  |  1
C0040147  |  thyroiditis  |  1
C0020550  |  hyperthyroidism  |  1
C0027765  |  nervous system disease  |  1
C0752347  |  dementia with lewy bodies  |  1
C0027765  |  neurological disease  |  1
C0027873  |  neuromyelitis optica  |  1
C0021831  |  bowel disease  |  1
C0007682  |  central nervous system disease  |  1
C0013384  |  dyskinesia  |  1
C0014544  |  epileptic seizure  |  1
C0024408  |  spinocerebellar ataxia type 3  |  1
C0004782  |  basal ganglia disorders  |  1
C0021390  |  inflammatory bowel disease  |  1
C0027765  |  nervous system diseases  |  1
C0011570  |  depression  |  1
C1848954  |  generalized dystonia  |  1
C0442874  |  neuropathy  |  1
C1261473  |  sarcoma  |  1
C0085261  |  proteus syndrome  |  1
C0026846  |  muscle atrophy  |  1
C0023520  |  leukodystrophy  |  1
C0851578  |  sleep disorders  |  1
C0016952  |  galactosemia  |  1
C0038868  |  progressive supranuclear palsy  |  1
C0393571  |  multiple system atrophy  |  1
C0085315  |  cerebral toxoplasmosis  |  1
C0006111  |  brain disorder  |  1
C0020538  |  hypertension  |  1
C0023524  |  progressive multifocal leukoencephalopathy  |  1
C0020255  |  hydrocephalus  |  1
C0270922  |  demyelinating neuropathy  |  1
C0006309  |  brucellosis  |  1
C0022116  |  ischemia  |  1
C0030567  |  parkinson's syndrome  |  1
C0001125  |  lactic acidosis  |  1
C0004114  |  astrocytoma  |  1
C0023890  |  cirrhosis  |  1
C0018920  |  cavernous hemangioma  |  1
C0007682  |  central nervous system diseases  |  1
C0030486  |  paraplegia  |  1
C0020676  |  hypothyroidism  |  1
C0006325  |  bruxism  |  1
C0007286  |  carpal tunnel syndrome  |  1
C0040156  |  thyrotoxicosis  |  1
C0149931  |  migraine  |  1
C0019202  |  wilson disease  |  1
C0031117  |  peripheral neuropathies  |  1
Curated Gene
Entrez_id | Symbol | Resource(Total Genes:8)
ADORA2A  |  135  |  CTD_human
SCN8A  |  6334  |  CTD_human
ATP7A  |  538  |  CTD_human
ADRB2  |  154  |  CTD_human
TRH  |  7200  |  CTD_human
HTR1A  |  3350  |  CTD_human
CHRM4  |  1132  |  CTD_human
CYP2D6  |  1565  |  CTD_human
Inferring Gene(Waiting for update.)
Text Mined Gene(Waiting for update.)
Locus(Waiting for update.)
Disease ID 521
Disease tremor
Integrated Phenotype(Waiting for update.)
Text Mined Phenotype
HPO | Name | Sentences' Count(Total Phenotypes:93)
HP:0030186  |  Essential tremor  |  30
HP:0001332  |  Dystonia  |  17
HP:0001251  |  Ataxia  |  17
HP:0002063  |  Muscle rigidity  |  12
HP:0100022  |  Movement disorder  |  11
HP:0000473  |  Spasmodic torticollis  |  9
HP:0002067  |  Bradykinesia  |  8
HP:0001300  |  Parkinsonism  |  8
HP:0012378  |  Fatigue  |  6
HP:0100543  |  Cognitive deficits  |  5
HP:0002073  |  Cerebellar ataxia, progressive  |  5
HP:0001260  |  Dysarthric speech  |  4
HP:0000726  |  Dementia  |  4
HP:0012531  |  Pain  |  4
HP:0002322  |  Resting tremor  |  4
HP:0001250  |  Seizures  |  4
HP:0000739  |  Anxiety  |  3
HP:0000360  |  Ringing in the ears  |  3
HP:0001336  |  Myoclonic jerks  |  3
HP:0009830  |  Peripheral neuritis  |  3
HP:0001347  |  Hyperreflexia  |  2
HP:0200085  |  Limb tremor  |  2
HP:0002354  |  Memory loss  |  2
HP:0001288  |  Gait disturbance  |  2
HP:0100315  |  Lewy bodies  |  2
HP:0001272  |  Cerebellar atrophy  |  2
HP:0001271  |  Polyneuropathy  |  2
HP:0002375  |  Decreased spontaneous movement  |  2
HP:0002174  |  Postural tremor  |  2
HP:0002070  |  Appendicular ataxia  |  2
HP:0000639  |  Nystagmus  |  2
HP:0002172  |  Postural instability  |  2
HP:0002315  |  Headaches  |  2
HP:0001310  |  Dysmetria  |  2
HP:0001317  |  Abnormality of the cerebellum  |  2
HP:0002066  |  Gait ataxia  |  1
HP:0100242  |  Sarcoma  |  1
HP:0002329  |  Drowsiness  |  1
HP:0008629  |  Pulsatile tinnitus  |  1
HP:0002180  |  Neurodegeneration  |  1
HP:0002197  |  Generalized seizures  |  1
HP:0100660  |  Dyskinesis  |  1
HP:0000741  |  Apathy  |  1
HP:0003763  |  Bruxism  |  1
HP:0003128  |  Lactic acidosis  |  1
HP:0002076  |  Migraine headaches  |  1
HP:0000713  |  Agitation  |  1
HP:0001268  |  Mental deterioration  |  1
HP:0010828  |  Hemifacial spasm  |  1
HP:0002378  |  Hand tremor  |  1
HP:0002141  |  Imbalanced walk  |  1
HP:0001048  |  Cavernous angioma  |  1
HP:0001824  |  Weight loss  |  1
HP:0011096  |  Demyelination  |  1
HP:0001289  |  Confusion  |  1
HP:0001258  |  Spastic paraplegia, lower limb  |  1
HP:0000707  |  Neurological abnormality  |  1
HP:0008303  |  Olivary degeneration  |  1
HP:0002345  |  Action tremor  |  1
HP:0001618  |  Dysphonia  |  1
HP:0000822  |  Hypertension  |  1
HP:0001394  |  Hepatic cirrhosis  |  1
HP:0003049  |  Ulnar deviation of wrists  |  1
HP:0000238  |  Nonsyndromal hydrocephalus  |  1
HP:0002079  |  Hypoplasia of the corpus callosum  |  1
HP:0007359  |  Partial seizures  |  1
HP:0002355  |  Difficulty walking  |  1
HP:0000821  |  Underactive thyroid  |  1
HP:0001324  |  Muscular weakness  |  1
HP:0002078  |  Truncal ataxia  |  1
HP:0012049  |  Spasmodic dysphonia  |  1
HP:0000716  |  Depression  |  1
HP:0003326  |  Muscle pain  |  1
HP:0001249  |  Mental retardation  |  1
HP:0003202  |  Neurogenic muscle atrophy, especially in the lower limbs  |  1
HP:0003470  |  Inability to move  |  1
HP:0002071  |  Extrapyramidal dysfunction  |  1
HP:0002529  |  Neuronal loss in central nervous system  |  1
HP:0012043  |  Pendular nystagmus  |  1
HP:0002346  |  Head tremor  |  1
HP:0030185  |  Isometric tremor  |  1
HP:0003256  |  Coagulopathy  |  1
HP:0000836  |  Overactive thyroid  |  1
HP:0001944  |  Dehydration  |  1
HP:0002415  |  Degeneration of white matter of brain  |  1
HP:0010550  |  Paraplegia  |  1
HP:0100646  |  Thyroiditis  |  1
HP:0001311  |  Neurophysiologic abnormalities  |  1
HP:0000496  |  Ocular movement abnormalities  |  1
HP:0000711  |  Restlessness  |  1
HP:0001941  |  acidemia  |  1
HP:0009592  |  Astrocytoma  |  1
HP:0002080  |  Intention tremor  |  1
Disease ID 521
Disease tremor
Manually Symptom
UMLS  | Name(Total Manually Symptoms:14)
C1959629  |  seizure
C1855534  |  logic syndrome
C1527344  |  dysphonia
C1521736  |  parkinson's disease
C0796095  |  c syndrome
C0524851  |  neurodegenerative disorder
C0426980  |  motor symptoms
C0426768  |  o sign
C0422833  |  ent symptoms
C0235394  |  wasting
C0235031  |  neurological symptoms
C0036572  |  seizures
C0027765  |  neurological disorders
C0026650  |  movement disorders
Text Mined Symptom
UMLS | Name | Sentences' Count(Total Symptoms:10)
C0030567  |  parkinson's disease  |  41
C0426980  |  motor symptoms  |  18
C0426768  |  o sign  |  7
C0026650  |  movement disorders  |  4
C0036572  |  seizures  |  3
C0524851  |  neurodegenerative disorder  |  3
C0036572  |  seizure  |  1
C0422833  |  ent symptoms  |  1
C1527344  |  dysphonia  |  1
C0235031  |  neurological symptoms  |  1
Manually Genotype(Total Text Mining Genotypes:0)
(Waiting for update.)
All Snps(Total Genotypes:7)
snpId pubmedId geneId geneSymbol diseaseId sourceId sentence score Year geneSymbol_dbSNP CHROMOSOME POS REF ALT
rs104894158192445081959EGR2umls:C0040822BeFreeInterestingly, Egr2(I268N/I268N) mutant mice maintain normal weight and have only mild tremor until 2 weeks after birth, at which point they rapidly develop worsening weakness and uniformly die within several days.0.0002714422009EGR21062813835AT
rs11868035245145726622SNCAumls:C0040822BeFreeBased on motor Unified Parkinson's Disease Rating Scale subscores, MAPT (P = .0002) and CCDC62 (P = .003) were predominantly associated with bradykinesia, and we further discovered associations between SREBF1 (rs11868035; P = .005) and gait impairment, SNCA (rs356220; P = .04) and rigidity, and GAK (rs1564282; P = .03) and tremor.0.0005428842014SREBF1;RAI11717811787GA
rs1564282245145726622SNCAumls:C0040822BeFreeBased on motor Unified Parkinson's Disease Rating Scale subscores, MAPT (P = .0002) and CCDC62 (P = .003) were predominantly associated with bradykinesia, and we further discovered associations between SREBF1 (rs11868035; P = .005) and gait impairment, SNCA (rs356220; P = .04) and rigidity, and GAK (rs1564282; P = .03) and tremor.0.0005428842014GAK4858525CT
rs28186505118435766120892LRRK2umls:C0040822BeFreeIn addition, we discovered a novel LRRK2 variant V1613A in a family with a tremor dominant form of AdPD; this variant was not present in controls.0.0021715352008LRRK21240319998TC
rs3463758417151837120892LRRK2umls:C0040822BeFreeWe identified a LRRK2 mutation leading to the G2019S amino acid substitution in a 79-year-old woman with frontotemporal lobar degeneration with ubiquitinated neuronal intranuclear inclusions (FTLD-U/NII) and a possible family history of tremor.0.0021715352007LRRK21240340400GA
rs3463758418539535120892LRRK2umls:C0040822BeFreeTremor was the predominant symptom in LRRK2 Gly2019Ser carriers (92% [homozygotes] vs 75% [heterozygotes] vs 69% [non-carriers]; Cochran-Armitage trend test p=0.0587).0.0021715352008LRRK21240340400GA
rs356220245145726622SNCAumls:C0040822BeFreeBased on motor Unified Parkinson's Disease Rating Scale subscores, MAPT (P = .0002) and CCDC62 (P = .003) were predominantly associated with bradykinesia, and we further discovered associations between SREBF1 (rs11868035; P = .005) and gait impairment, SNCA (rs356220; P = .04) and rigidity, and GAK (rs1564282; P = .03) and tremor.0.0005428842014LOC105377329489720189TC
GWASdb Annotation(Total Genotypes:0)
(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
1135329615rs3794087GTrs3794087227642531.00E-07NA1.43[1.26-1.64] 436 European ancestry cases; 928 European ancestry controlsEuropean(1364)ALL(1364)EUR(1364)ALL(1364)Essential tremorHPOID:0001337TremorDOID:4990essential tremorD020329Essential TremorEFOID:0003108essential tremorMovement disorderNAResearch Support, Non-U.S. Gov'tCSLC1A2
1577963887rs9652490AGrs9652490191828061.00E-09NA1.55[1.35-1.79] 452 cases; 14,378 controlsNOPOP(14830)ALL(14830)NOPOP(14830)ALL(14830)Essential tremorHPOID:0001337TremorDOID:4990essential tremorD020329Essential TremorEFOID:0003108essential tremorMovement disorderrs9652490-GResearch Support, N.I.H., ExtramuralGNA
Mapped by lexical matching(Total Items:0)
(Waiting for update.)
Mapped by homologous gene(Total Items:0)
(Waiting for update.)
Chemical(Total Drugs:94)
CUI ChemicalName ChemicalID CasRN DiseaseName DiseaseID DirectEvidence PubMedIDs
C0040822s-adenosylmethionineD01243629908-03-0tremorMESH:D014202marker/mechanism10973524
C0040822amitriptylineD00063950-48-6tremorMESH:D014202marker/mechanism11270916
C0040822amitriptylineD00063950-48-6tremorMESH:D014202therapeutic2530142
C0040822atenololD00126229122-68-7tremorMESH:D014202marker/mechanism6487471
C0040822atropineD00128551-55-8tremorMESH:D014202therapeutic10683491
C0040822buspironeD00206536505-84-7tremorMESH:D014202marker/mechanism10762688
C0040822buspironeD00206536505-84-7tremorMESH:D014202therapeutic16643965
C0040822caffeineD0021101958/8/2tremorMESH:D014202marker/mechanism12044659
C0040822carbacholD002217-tremorMESH:D014202marker/mechanism1189819
C0040822carbamazepineD002220298-46-4tremorMESH:D014202marker/mechanism16116141
C0040822carbamazepineD002220298-46-4tremorMESH:D014202therapeutic8166325
C0040822carbidopaD00223038821-49-7tremorMESH:D014202therapeutic3670563
C0040822ceftazidimeD00244278439-06-2tremorMESH:D014202marker/mechanism3046579
C0040822celecoxibD000068579-tremorMESH:D014202marker/mechanism12380707
C0040822chlorpromazineD00274650-53-3tremorMESH:D014202marker/mechanism10082231
C0040822cimetidineD00292751481-61-9tremorMESH:D014202marker/mechanism7205315
C0040822cinnarizineD002936298-57-7tremorMESH:D014202marker/mechanism3147743
C0040822ciprofloxacinD00293985721-33-1tremorMESH:D014202marker/mechanism17357133
C0040822citalopramD01528359729-33-8tremorMESH:D014202marker/mechanism15567557
C0040822clonidineD0030004205-90-7tremorMESH:D014202therapeutic7146044
C0040822clozapineD0030245786-21-0tremorMESH:D014202marker/mechanism10435384
C0040822clozapineD0030245786-21-0tremorMESH:D014202therapeutic16643965
C0040822cyclosporineD01657259865-13-3tremorMESH:D014202marker/mechanism10665942
C0040822cyproheptadineD003533129-03-3tremorMESH:D014202therapeutic10762688
C0040822droxidopaD01510323651-95-8tremorMESH:D014202therapeutic986992
C0040822doxycyclineD004318564-25-0tremorMESH:D014202marker/mechanism9004058
C0040822erythromycinD004917114-07-8tremorMESH:D014202marker/mechanism18270792
C0040822ethosuximideD00501377-67-8tremorMESH:D014202therapeutic1350061
C0040822etomidateD00504533125-97-2tremorMESH:D014202marker/mechanism3344940
C0040822felbamateC04736025451-15-4tremorMESH:D014202marker/mechanism9848129
C0040822fluconazoleD01572586386-73-4tremorMESH:D014202marker/mechanism1291872
C0040822fluoxetineD00547354910-89-3tremorMESH:D014202marker/mechanism15177061
C0040822fluoxetineD00547354910-89-3tremorMESH:D014202therapeutic8166325
C0040822fluvoxamineD01666654739-18-3tremorMESH:D014202marker/mechanism19050415
C0040822gabapentinC04002960142-96-3tremorMESH:D014202therapeutic15503741
C0040822haloperidolD00622052-86-8tremorMESH:D014202marker/mechanism10389620
C0040822haloperidolD00622052-86-8tremorMESH:D014202therapeutic9681765
C0040822imipramineD00709950-49-7tremorMESH:D014202marker/mechanism15894058
C0040822imipramineD00709950-49-7tremorMESH:D014202therapeutic2530142
C0040822indomethacinD00721353-86-1tremorMESH:D014202marker/mechanism8219437
C0040822ivermectinD00755970288-86-7tremorMESH:D014202marker/mechanism22044330
C0040822labetalolD00774136894-69-6tremorMESH:D014202marker/mechanism2370642
C0040822lamotrigineC04778184057-84-1tremorMESH:D014202marker/mechanism8101290
C0040822lisurideD00809018016-80-3tremorMESH:D014202therapeutic3670563
C0040822medroxyprogesterone acetateD01725871-58-9tremorMESH:D014202marker/mechanism86447
C0040822meloxicamC06575771125-38-7tremorMESH:D014202marker/mechanism20073572
C0040822methadoneD00869176-99-3tremorMESH:D014202marker/mechanism11783819
C0040822dextromethorphanD003915125-71-3tremorMESH:D014202marker/mechanism1557278
C0040822methotrexateD0087271959/5/2tremorMESH:D014202marker/mechanism1389541
C0040822methylphenidateD008774113-45-1tremorMESH:D014202marker/mechanism19745210
C0040822metoprololD00879037350-58-6tremorMESH:D014202therapeutic6405633
C0040822mexiletineD00880131828-71-4tremorMESH:D014202marker/mechanism11009230
C0040822mitoxantroneD00894265271-80-9tremorMESH:D014202marker/mechanism2564552
C0040822nicotineD009538-tremorMESH:D014202marker/mechanism11070179
C0040822nitroprussideD00959915078-28-1tremorMESH:D014202marker/mechanism10727906
C0040822nizatidineD01656776963-41-2tremorMESH:D014202marker/mechanism15303455
C0040822nortriptylineD00966172-69-5tremorMESH:D014202marker/mechanism10435776
C0040822ofloxacinD01524282419-36-1tremorMESH:D014202marker/mechanism10388331
C0040822olanzapineC076029132539-06-1tremorMESH:D014202marker/mechanism10847307
C0040822olanzapineC076029132539-06-1tremorMESH:D014202therapeutic9699709
C0040822oxycodoneD01009876-42-6tremorMESH:D014202marker/mechanism11210406
C0040822pefloxacinD01536670458-92-3tremorMESH:D014202marker/mechanism3165976
C0040822pentagastrinD0104185534-95-2tremorMESH:D014202marker/mechanism672379
C0040822pentobarbitalD01042476-74-4tremorMESH:D014202therapeutic7639639
C0040822phenylpropanolamineD01066514838-15-4tremorMESH:D014202marker/mechanism7452888
C0040822phenytoinD01067257-41-0tremorMESH:D014202marker/mechanism11837377
C0040822phenytoinD01067257-41-0tremorMESH:D014202therapeutic3929313
C0040822picrotoxinD010852124-87-8tremorMESH:D014202marker/mechanism181685
C0040822pilocarpineD01086292-13-7tremorMESH:D014202marker/mechanism1324090
C0040822piroxicamD01089436322-90-4tremorMESH:D014202marker/mechanism3929867
C0040822prazosinD01122419216-56-9tremorMESH:D014202therapeutic7990972
C0040822pregabalinD000069583-tremorMESH:D014202therapeutic18394207
C0040822procyclidineD01135277-37-2tremorMESH:D014202therapeutic9877318
C0040822promazineD01139558-40-2tremorMESH:D014202therapeutic9681765
C0040822propranololD011433525-66-6tremorMESH:D014202marker/mechanism6487471
C0040822propranololD011433525-66-6tremorMESH:D014202therapeutic11096749
C0040822protriptylineD011530438-60-8tremorMESH:D014202marker/mechanism7334152
C0040822remoxiprideD01733080125-14-0tremorMESH:D014202marker/mechanism8889913
C0040822reserpineD01211050-55-5tremorMESH:D014202marker/mechanism11999899
C0040822ropivacaineC03766384057-95-4tremorMESH:D014202marker/mechanism12694015
C0040822sotalolD0130153930-20-9tremorMESH:D014202therapeutic6115732
C0040822spermineD01309671-44-3tremorMESH:D014202marker/mechanism9641557
C0040822tacrineD013619321-64-2tremorMESH:D014202marker/mechanism15680188
C0040822tacrolimusD016559109581-93-3tremorMESH:D014202marker/mechanism10612521
C0040822terfenadineD01659350679-08-8tremorMESH:D014202marker/mechanism8434887
C0040822thalidomideD01379250-35-1tremorMESH:D014202marker/mechanism12724497
C0040822theophyllineD01380658-55-9tremorMESH:D014202marker/mechanism1424400
C0040822timololD01399926839-75-8tremorMESH:D014202therapeutic8363291
C0040822topiramateC05234297240-79-4tremorMESH:D014202marker/mechanism19050415
C0040822trihexyphenidylD014282144-11-6tremorMESH:D014202marker/mechanism3088650
C0040822trihexyphenidylD014282144-11-6tremorMESH:D014202therapeutic391328
C0040822valproic acidD01463599-66-1tremorMESH:D014202marker/mechanism10435776
C0040822valproic acidD01463599-66-1tremorMESH:D014202therapeutic17357133
C0040822vincristineD014750-tremorMESH:D014202marker/mechanism4518764
FDA approved drug and dosage information(Total Drugs:43)
DiseaseID Drug_name active_ingredients strength Dosage Form/Route Marketing Status TE code RLD RS
MESH:D014202neurontingabapentin100MGCAPSULE;ORALPrescriptionABYesNo
MESH:D014202neurontingabapentin600MGTABLET;ORALPrescriptionABYesNo
MESH:D014202neurontingabapentin250MG/5MLSOLUTION;ORALPrescriptionAAYesYes
MESH:D014202neurontingabapentin0SOLUTION; ORALPrescriptionNoneNoNo
MESH:D014202neurontingabapentin600MGTABLET; ORALPrescriptionNoneNoNo
MESH:D014202neurontingabapentin800MGCAPSULE; ORALPrescriptionNoneNoNo
MESH:D014202neurontingabapentin250MG/5MLSOLUTION; ORALPrescriptionNoneNoNo
MESH:D014202lamictallamotrigine100MGTABLET;ORALPrescriptionABYesNo
MESH:D014202lamictallamotrigine100MGTABLET;ORALPrescriptionABYesNo
MESH:D014202lamictallamotrigine100MGTABLET;ORALPrescriptionABYesNo
MESH:D014202lamictal xrlamotrigine25MGTABLET, EXTENDED RELEASE;ORALPrescriptionABYesNo
MESH:D014202lamictal xrlamotrigine25MGTABLET, EXTENDED RELEASE;ORALPrescriptionABYesNo
MESH:D014202lamictal xrlamotrigine25MGTABLET, EXTENDED RELEASE;ORALPrescriptionABYesNo
MESH:D014202ciprociprofloxacin400MG/40ML (10MG/ML)INJECTABLE;INJECTIONDiscontinuedNoneYesNo
MESH:D014202ciprociprofloxacin250MG/5MLFOR SUSPENSION;ORALPrescriptionABYesNo
MESH:D014202axidnizatidine150MGCAPSULE;ORALDiscontinuedNoneNoNo
MESH:D014202axidnizatidine15MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasonsSOLUTION;ORALDiscontinuedNoneYesNo
MESH:D014202mobicmeloxicam7.5MGTABLET;ORALPrescriptionABYesNo
MESH:D014202mobicmeloxicam7.5MG/5MLSUSPENSION;ORALPrescriptionNoneYesYes
MESH:D014202daytranamethylphenidate10MG/9HR (1.1MG/HR)FILM, EXTENDED RELEASE;TRANSDERMALPrescriptionNoneYesNo
MESH:D014202daytranamethylphenidate10MG/9HR (1.1MG/HR)FILM, EXTENDED RELEASE;TRANSDERMALPrescriptionNoneYesNo
MESH:D014202daytranamethylphenidate10MG/9HR (1.1MG/HR)FILM, EXTENDED RELEASE;TRANSDERMALPrescriptionNoneYesNo
MESH:D014202celebrexcelecoxib100MGCAPSULE;ORALPrescriptionABYesNo
MESH:D014202celebrexcelecoxib100MGCAPSULE;ORALPrescriptionNoneNoNo
MESH:D014202zyprexaolanzapine2.5MGTABLET;ORALPrescriptionABYesNo
MESH:D014202zyprexaolanzapine2.5MGTABLET;ORALPrescriptionABYesNo
MESH:D014202zyprexaolanzapine10MG/VIALINJECTABLE;INTRAMUSCULARPrescriptionAPYesYes
MESH:D014202zyprexaolanzapine10MG/VIALINJECTABLE;INTRAMUSCULARPrescriptionAPYesYes
MESH:D014202zyprexaolanzapine2.5MGTABLET;ORALPrescriptionABYesNo
MESH:D014202zyprexaolanzapine2.5MGTABLET;ORALPrescriptionABYesNo
MESH:D014202zyprexaolanzapine10MG/VIALINJECTABLE;INTRAMUSCULARPrescriptionAPYesYes
MESH:D014202zyprexaolanzapine10MG/VIALINJECTABLE;INTRAMUSCULARPrescriptionAPYesYes
MESH:D014202topamaxtopiramate100MGTABLET;ORALPrescriptionABYesYes
MESH:D014202topamaxtopiramate15MGCAPSULE;ORALPrescriptionABYesNo
MESH:D014202topamaxtopiramate100MGTABLET;ORALPrescriptionABYesYes
MESH:D014202topamaxtopiramate15MGCAPSULE;ORALPrescriptionABYesNo
MESH:D014202topamaxtopiramate100MGTABLET;ORALPrescriptionABYesYes
MESH:D014202topamaxtopiramate15MGCAPSULE;ORALPrescriptionABYesNo
MESH:D014202topamaxtopiramate100MGTABLET;ORALPrescriptionABYesYes
MESH:D014202topamaxtopiramate15MGCAPSULE;ORALPrescriptionABYesNo
MESH:D014202lyricapregabalin25MGCAPSULE;ORALPrescriptionNoneYesNo
MESH:D014202lyricapregabalin25MGCAPSULE; ORALPrescriptionNoneNoNo
MESH:D014202lyricapregabalin25MGCAPSULE; ORALPrescriptionNoneNoNo
FDA labeling changes(Total Drugs:43)
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:D01420212/10/2000neurontingabapentinAdjunctive therapy in the treatment of partial seizuresSafety and effectiveness established down to 3 years Neuropsychiatric AE's identified in 3-12 year olds Oral clearance normalized per body weight increased in childrenLabelingB---Parke-Davis2/2/2000FALSE'
MESH:D01420212/10/2000neurontingabapentinAdjunctive therapy in the treatment of partial seizuresSafety and effectiveness established down to 3 years Neuropsychiatric AE's identified in 3-12 year olds Oral clearance normalized per body weight increased in childrenLabelingB---Parke-Davis2/2/2000FALSE'
MESH:D01420212/10/2000neurontingabapentinAdjunctive therapy in the treatment of partial seizuresSafety and effectiveness established down to 3 years Neuropsychiatric AE's identified in 3-12 year olds Oral clearance normalized per body weight increased in childrenLabelingB---Parke-Davis2/2/2000FALSE'
MESH:D01420212/10/2000neurontingabapentinAdjunctive therapy in the treatment of partial seizuresSafety and effectiveness established down to 3 years Neuropsychiatric AE's identified in 3-12 year olds Oral clearance normalized per body weight increased in childrenLabelingB---Parke-Davis2/2/2000FALSE'
MESH:D01420212/10/2000neurontingabapentinAdjunctive therapy in the treatment of partial seizuresSafety and effectiveness established down to 3 years Neuropsychiatric AE's identified in 3-12 year olds Oral clearance normalized per body weight increased in childrenLabelingB---Parke-Davis2/2/2000FALSE'
MESH:D01420212/10/2000neurontingabapentinAdjunctive therapy in the treatment of partial seizuresSafety and effectiveness established down to 3 years Neuropsychiatric AE's identified in 3-12 year olds Oral clearance normalized per body weight increased in childrenLabelingB---Parke-Davis2/2/2000FALSE'
MESH:D01420212/10/2000neurontingabapentinAdjunctive therapy in the treatment of partial seizuresSafety and effectiveness established down to 3 years Neuropsychiatric AE's identified in 3-12 year olds Oral clearance normalized per body weight increased in childrenLabelingB---Parke-Davis2/2/2000FALSE'
MESH:D01420201/17/2003lamictallamotrigineAdjunctive therapy for partial seizuresExtended 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 AELabelingB---GlaxoSmithKline02/14/2007FALSE'
MESH:D0142028/5/2009lamictallamotrigineAdjunctive treatment for partial seizures in pediatric patients 1  24 monthsSafety 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%)LabelingB---GlaxoSmithKline02/14/2007FALSE'
MESH:D01420205/18/2015lamictallamotrigineMaintenance 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 studyLabeling-P--GlaxoSmithKline-FALSE
MESH:D01420205/29/2009lamictal xrlamotrigineAdjunctive therapy for partial onset seizures in patients e13 years of ageExtended 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 formLabeling-P--GlaxoSmithKline-FALSE'
MESH:D01420201/29/2010lamictal xrlamotrigineAdjunctive therapy for Primary Generalized Tonic-Clonic seizuresNew 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 studiesLabeling-P--GlaxoSmithKline-FALSE'
MESH:D01420204/25/2011lamictal xrlamotrigineMonotherapy 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 indicationLabeling-P--GlaxoSmithKline-FALSE'
MESH:D01420203/25/2004ciprociprofloxacinComplicated UTI and pyelonephritisIndicated 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, respectivelyLabelingB---Bayer12/18/2003FALSE'
MESH:D01420203/25/2004ciprociprofloxacinComplicated UTI and pyelonephritisIndicated 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, respectivelyLabelingB---Bayer12/18/2003FALSE'
MESH:D01420205/25/2004axidnizatidineEsophagitis, and heartburn due to GERDIndicated in pediatric patients 12 years and older Information on dose, PK parameters, and AE profileLabelingB---Reliant Pharms-FALSE'
MESH:D01420205/25/2004axidnizatidineEsophagitis, and heartburn due to GERDIndicated in pediatric patients 12 years and older Information on dose, PK parameters, and AE profileLabelingB---Reliant Pharms-FALSE'
MESH:D01420211/8/2005mobicmeloxicamRelief of signs and symptoms of pauciarticular or polyarticular course Juvenile Rheumatoid ArthritisSafety 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 studiesLabeling--B, P-Boehringer Ingelheim04/15/2005FALSE'
MESH:D01420211/8/2005mobicmeloxicamRelief of signs and symptoms of pauciarticular or polyarticular course Juvenile Rheumatoid ArthritisSafety 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 studiesLabeling--B, P-Boehringer Ingelheim04/15/2005FALSE'
MESH:D0142026/4/2006daytranamethylphenidateADHDSummary is pendingLabeling-P--Shire-FALSE'
MESH:D01420212/14/2009daytranamethylphenidatePostmarketing safety studyInformation added to Warnings and Adverse Reactions on skin reactions observed in a postmarketing dermal study in pediatric patientsLabeling-P--Shire-FALSE'
MESH:D01420206/29/2010daytranamethylphenidateADHDExpanded 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 studiesLabeling-P--Shire-FALSE'
MESH:D01420212/15/2006celebrexcelecoxibRelief 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, AEsLabelingB---Pfizer08/23/2006FALSE'
MESH:D01420212/15/2006celebrexcelecoxibRelief 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, AEsLabelingB---Pfizer08/23/2006FALSE'
MESH:D01420208/14/2008zyprexaolanzapineschizophrenia; bipolar disorderSafety 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---Lilly10/1/2007FALSE'
MESH:D01420208/14/2008zyprexaolanzapineschizophrenia; bipolar disorderSafety 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---Lilly10/1/2007FALSE'
MESH:D01420208/14/2008zyprexaolanzapineschizophrenia; bipolar disorderSafety 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---Lilly10/1/2007FALSE'
MESH:D01420208/14/2008zyprexaolanzapineschizophrenia; bipolar disorderSafety 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---Lilly10/1/2007FALSE'
MESH:D0142024/12/2009zyprexaolanzapineTreatment of manic or mixed episodes of bipolar I disorder and schizophrenia in adolescents ages 13-17Extended 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 studiesLabelingB---Lilly10/1/2007TRUE'
MESH:D0142024/12/2009zyprexaolanzapineTreatment of manic or mixed episodes of bipolar I disorder and schizophrenia in adolescents ages 13-17Extended 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 studiesLabelingB---Lilly10/1/2007TRUE'
MESH:D0142024/12/2009zyprexaolanzapineTreatment of manic or mixed episodes of bipolar I disorder and schizophrenia in adolescents ages 13-17Extended 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 studiesLabelingB---Lilly10/1/2007TRUE'
MESH:D0142024/12/2009zyprexaolanzapineTreatment of manic or mixed episodes of bipolar I disorder and schizophrenia in adolescents ages 13-17Extended 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 studiesLabelingB---Lilly10/1/2007TRUE'
MESH:D01420212/22/2009topamaxtopiramateMigraine ProphylaxisSafety 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 UseLabeling-P--Ortho-McNeil-Janssen-FALSE'
MESH:D01420212/22/2009topamaxtopiramateMigraine ProphylaxisSafety 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 UseLabeling-P--Ortho-McNeil-Janssen-FALSE'
MESH:D01420212/22/2009topamaxtopiramateAdjunctive Treatment for Partial Onset Epilepsy in Infants and Toddlers 1 to 24 monthsEffectiveness 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 UseLabelingB---Ortho-McNeil-Janssen07/24/2008FALSE'
MESH:D01420212/22/2009topamaxtopiramateAdjunctive Treatment for Partial Onset Epilepsy in Infants and Toddlers 1 to 24 monthsEffectiveness 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 UseLabelingB---Ortho-McNeil-Janssen07/24/2008FALSE'
MESH:D01420207/15/2011topamaxtopiramateMonotherapy for partial onset or primary generalized tonic-clonic seizuresExpanded 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 studyLabeling-P--Janssen-FALSE'
MESH:D01420207/15/2011topamaxtopiramateMonotherapy for partial onset or primary generalized tonic-clonic seizuresExpanded 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 studyLabeling-P--Janssen-FALSE'
MESH:D01420203/28/2014topamaxtopiramateProphylaxis of migraine headacheApproved 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 studyLabeling-P--Janssen-FALSE'
MESH:D01420203/28/2014topamaxtopiramateProphylaxis of migraine headacheApproved 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 studyLabeling-P--Janssen-FALSE'
MESH:D01420212/22/2016lyricapregabalinFibromyalgiaSafety and efficacy in pediatric patients have not been established. A 15-week, placebo-controlled trial was conducted with 107 pediatric patients with fibromyalgia, ages 12 through 17 years . The primary efficacy endpoint of change from baseline to Week 15 in mean pain intensity showed numerically greater improvement for the pregabalin-treated patients compared to placebo-treated patients, but did not reach statistical significance. The most frequently observed adverse reactions in the clinical trial included dizziness, nausea, headache, weight increased, and fatigue. The overall safety profile in adolescents was similar to that observed in adults with fibromyalgia. Postmarketing study.Labeling-P--PF Prism CV-FALSE
MESH:D01420212/22/2016lyricapregabalinFibromyalgiaSafety and efficacy in pediatric patients have not been established. A 15-week, placebo-controlled trial was conducted with 107 pediatric patients with fibromyalgia, ages 12 through 17 years . The primary efficacy endpoint of change from baseline to Week 15 in mean pain intensity showed numerically greater improvement for the pregabalin-treated patients compared to placebo-treated patients, but did not reach statistical significance. The most frequently observed adverse reactions in the clinical trial included dizziness, nausea, headache, weight increased, and fatigue. The overall safety profile in adolescents was similar to that observed in adults with fibromyalgia. Postmarketing study.Labeling-P--PF Prism CV-FALSE
MESH:D01420212/22/2016lyricapregabalinFibromyalgiaSafety and efficacy in pediatric patients have not been established. A 15-week, placebo-controlled trial was conducted with 107 pediatric patients with fibromyalgia, ages 12 through 17 years . The primary efficacy endpoint of change from baseline to Week 15 in mean pain intensity showed numerically greater improvement for the pregabalin-treated patients compared to placebo-treated patients, but did not reach statistical significance. The most frequently observed adverse reactions in the clinical trial included dizziness, nausea, headache, weight increased, and fatigue. The overall safety profile in adolescents was similar to that observed in adults with fibromyalgia. Postmarketing study.Labeling-P--PF Prism CV-FALSE