methylphenidate ๐Ÿถ Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
1767 113-45-1

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • methylphenidate
  • calocain
  • methylphenidan
  • phenidylate
  • methylphenidate hydrochloride
  • concerta
  • methylphenidate HCl
A central nervous system stimulant used most commonly in the treatment of ATTENTION DEFICIT DISORDER in children and for NARCOLEPSY. Its mechanisms appear to be similar to those of DEXTROAMPHETAMINE. The d-isomer of this drug is referred to as DEXMETHYLPHENIDATE HYDROCHLORIDE.
  • Molecular weight: 233.31
  • Formula: C14H19NO2
  • CLOGP: 2.56
  • LIPINSKI: 0
  • HAC: 3
  • HDO: 1
  • TPSA: 38.33
  • ALOGS: -3.11
  • ROTB: 4

  • Status: OFP

  • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
30 mg O

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 1 Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 4.29 ยตM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 22 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution) 2.20 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 9.42 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.85 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 4.80 hours Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
Dec. 5, 1955 FDA NOVARTIS

FDA Adverse Event Reporting System (Female)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Suicidal ideation 342.73 11.18 300 36623 55085 50513116
Product quality issue 255.40 11.18 198 36725 30660 50537541
Anxiety 246.22 11.18 454 36469 177152 50391049
Product substitution issue 223.41 11.18 135 36788 13922 50554279
Agitation 212.55 11.18 227 36696 53157 50515044
Depression 204.66 11.18 403 36520 165020 50403181
Aggression 173.61 11.18 135 36788 20981 50547220
Tachycardia 165.21 11.18 276 36647 99487 50468714
Disturbance in attention 161.55 11.18 153 36770 31033 50537168
Drug abuse 160.72 11.18 208 36715 59638 50508563
No adverse event 155.67 11.18 155 36768 33423 50534778
Attention deficit hyperactivity disorder 149.63 11.18 59 36864 2370 50565831
Irritability 135.06 11.18 133 36790 28293 50539908
Abnormal behaviour 134.72 11.18 113 36810 19545 50548656
Pre-existing condition improved 130.72 11.18 75 36848 7022 50561179
Tic 128.65 11.18 44 36879 1173 50567028
Intentional overdose 119.93 11.18 185 36738 62319 50505882
Precocious puberty 112.04 11.18 27 36896 189 50568012
Cataplexy 102.85 11.18 36 36887 1030 50567171
Suicide attempt 99.06 11.18 153 36770 51579 50516622
Mydriasis 96.26 11.18 72 36851 10555 50557646
Tremor 90.33 11.18 234 36689 114669 50453532
Intentional self-injury 89.66 11.18 97 36826 23015 50545186
Application site erythema 89.08 11.18 50 36873 4488 50563713
Hallucination, auditory 89.05 11.18 69 36854 10659 50557542
Psychotic disorder 88.95 11.18 94 36829 21718 50546483
Joint swelling 83.92 11.18 37 36886 245249 50322952
Therapeutic response unexpected 82.24 11.18 78 36845 15837 50552364
Contraindicated product administered 79.95 11.18 8 36915 148950 50419251
Pulmonary malformation 77.88 11.18 20 36903 187 50568014
Wrong technique in product usage process 75.52 11.18 141 36782 55369 50512832
Toxicity to various agents 72.47 11.18 327 36596 212172 50356029
Glossodynia 71.40 11.18 3 36920 115566 50452635
Product administered at inappropriate site 71.00 11.18 35 36888 2408 50565793
Overdose 70.19 11.18 195 36728 99532 50468669
Psychomotor hyperactivity 69.00 11.18 56 36867 9245 50558956
Sleep apnoea syndrome 68.82 11.18 86 36837 23782 50544419
Apathy 68.05 11.18 51 36872 7497 50560704
Somnambulism 67.35 11.18 43 36880 4881 50563320
Application site irritation 65.08 11.18 29 36894 1586 50566615
Insomnia 64.85 11.18 276 36647 174589 50393612
Chorea 63.58 11.18 27 36896 1313 50566888
Feeling abnormal 62.89 11.18 218 36705 125274 50442927
Rheumatoid arthritis 62.55 11.18 35 36888 202515 50365686
Diarrhoea 60.85 11.18 223 36700 588253 49979948
Rapid eye movement sleep behaviour disorder 60.12 11.18 16 36907 174 50568027
Somnolence 58.52 11.18 246 36677 154739 50413462
Bruxism 58.33 11.18 33 36890 3007 50565194
Product colour issue 57.92 11.18 20 36903 549 50567652
Hallucination 57.91 11.18 114 36809 46543 50521658
Intentional product misuse 57.78 11.18 114 36809 46620 50521581
Acute kidney injury 57.68 11.18 49 36874 228009 50340192
Product administration error 56.83 11.18 71 36852 19628 50548573
Panic attack 56.26 11.18 70 36853 19272 50548929
Swelling 56.09 11.18 39 36884 200833 50367368
Arthralgia 55.28 11.18 152 36771 438550 50129651
Dystonia 55.14 11.18 55 36868 11871 50556330
Systemic lupus erythematosus 55.14 11.18 17 36906 140605 50427596
Drug dependence 55.07 11.18 70 36853 19689 50548512
Enuresis 54.53 11.18 28 36895 2101 50566100
Obsessive-compulsive disorder 52.85 11.18 32 36891 3308 50564893
Dyskinesia 52.75 11.18 82 36841 27779 50540422
Social anxiety disorder 52.35 11.18 17 36906 384 50567817
Lung cyst 51.97 11.18 14 36909 160 50568041
Infusion related reaction 51.33 11.18 30 36893 169527 50398674
Arthropathy 50.62 11.18 26 36897 157880 50410321
Educational problem 49.21 11.18 16 36907 363 50567838
Lower respiratory tract infection 48.82 11.18 6 36917 95195 50473006
Impulsive behaviour 48.76 11.18 23 36900 1435 50566766
Parasomnia 48.28 11.18 16 36907 386 50567815
Anaemia 47.63 11.18 69 36854 252387 50315814
Headache 45.78 11.18 567 36356 505968 50062233
Peripheral swelling 45.38 11.18 50 36873 205886 50362315
Euphoric mood 44.80 11.18 31 36892 4024 50564177
Crying 44.23 11.18 64 36859 20352 50547849
Completed suicide 44.17 11.18 202 36721 131687 50436514
Neutropenia 43.63 11.18 27 36896 147938 50420263
Muscle twitching 43.52 11.18 55 36868 15376 50552825
Muscle contracture 43.34 11.18 20 36903 1187 50567014
Withdrawal syndrome 42.35 11.18 58 36865 17532 50550669
Growth retardation 42.30 11.18 19 36904 1059 50567142
Drug diversion 41.64 11.18 17 36906 748 50567453
Wound 41.09 11.18 13 36910 105781 50462420
Restlessness 40.73 11.18 69 36854 25104 50543097
Infection 40.34 11.18 40 36883 172914 50395287
Pericarditis 40.25 11.18 5 36918 78684 50489517
Memory impairment 39.84 11.18 138 36785 79222 50488979
Application site pruritus 39.80 11.18 28 36895 3731 50564470
Febrile neutropenia 39.76 11.18 11 36912 97656 50470545
Respiratory tract malformation 39.58 11.18 10 36913 87 50568114
Hallucination, visual 38.90 11.18 54 36869 16528 50551673
Pre-eclampsia 38.86 11.18 38 36885 8006 50560195
Maternal exposure during breast feeding 38.61 11.18 26 36897 3228 50564973
Splenic infarction 38.47 11.18 20 36903 1540 50566661
Treatment failure 38.03 11.18 27 36896 137610 50430591
Migraine 37.87 11.18 131 36792 75149 50493052
Paranoia 37.64 11.18 42 36881 10306 50557895
Heart rate increased 37.63 11.18 133 36790 77117 50491084
Seizure 37.59 11.18 178 36745 117696 50450505
Abdominal discomfort 37.44 11.18 70 36853 231571 50336630
Depressed mood 37.32 11.18 79 36844 33944 50534257
Rash 36.93 11.18 179 36744 437292 50130909
Hyperventilation 36.85 11.18 31 36892 5378 50562823
Bipolar disorder 36.60 11.18 34 36889 6723 50561478
Drug intolerance 36.49 11.18 65 36858 219039 50349162
Anger 36.18 11.18 43 36880 11290 50556911
Blister 35.95 11.18 9 36914 85409 50482792
Haemoglobin decreased 35.09 11.18 25 36898 127191 50441010
Emotional disorder 34.68 11.18 43 36880 11793 50556408
Dyspnoea 34.56 11.18 246 36677 547362 50020839
Affective disorder 33.88 11.18 29 36894 5152 50563049
Application site urticaria 33.77 11.18 11 36912 251 50567950
Multiple sclerosis relapse 33.20 11.18 87 36836 42877 50525324
Delusion of parasitosis 33.19 11.18 6 36917 6 50568195
Negative thoughts 33.14 11.18 15 36908 851 50567350
Death 33.04 11.18 124 36799 325255 50242946
Exposure during pregnancy 32.43 11.18 174 36749 120841 50447360
Livedo reticularis 32.30 11.18 20 36903 2152 50566049
Feeling jittery 31.83 11.18 40 36883 11120 50557081
Mania 30.93 11.18 39 36884 10877 50557324
General physical health deterioration 30.90 11.18 35 36888 142399 50425802
Snoring 30.80 11.18 23 36900 3361 50564840
Hepatic enzyme increased 30.63 11.18 33 36890 137347 50430854
Weight decreased 29.95 11.18 269 36654 220976 50347225
Exposure via breast milk 29.63 11.18 17 36906 1591 50566610
Sepsis 29.56 11.18 32 36891 132893 50435308
Solar urticaria 29.05 11.18 7 36916 49 50568152
Serotonin syndrome 28.99 11.18 59 36864 24654 50543547
Perinatal depression 28.95 11.18 12 36911 549 50567652
Drug hypersensitivity 28.61 11.18 91 36832 250919 50317282
Sleep-related eating disorder 28.44 11.18 13 36910 755 50567446
Post-traumatic stress disorder 27.96 11.18 24 36899 4279 50563922
Mood altered 27.60 11.18 40 36883 12733 50555468
Hypersomnia 27.50 11.18 44 36879 15270 50552931
Lactation disorder 27.39 11.18 10 36913 324 50567877
Pneumonia 27.37 11.18 163 36760 378238 50189963
Thrombocytopenia 27.01 11.18 32 36891 127641 50440560
Pancytopenia 26.67 11.18 14 36909 84016 50484185
Meningitis streptococcal 26.24 11.18 8 36915 146 50568055
Application site rash 25.99 11.18 18 36905 2339 50565862
Mobility decreased 25.85 11.18 13 36910 79935 50488266
Product taste abnormal 25.77 11.18 16 36907 1729 50566472
Interstitial lung disease 25.73 11.18 4 36919 53172 50515029
Drug screen negative 25.59 11.18 9 36914 261 50567940
Optic disc haemorrhage 25.55 11.18 6 36917 37 50568164
Tachyphrenia 25.20 11.18 14 36909 1231 50566970
Adhesive tape use 24.90 11.18 4 36919 0 50568201
Psychiatric symptom 24.76 11.18 23 36900 4547 50563654
Chronic fatigue syndrome 24.75 11.18 13 36910 1022 50567179
Maternal exposure during pregnancy 24.31 11.18 50 36873 159728 50408473
Burnout syndrome 24.30 11.18 8 36915 189 50568012
Multiple organ dysfunction syndrome 23.87 11.18 4 36919 50333 50517868
Alopecia 23.82 11.18 95 36828 244952 50323249
Hangover 23.78 11.18 14 36909 1375 50566826
Cyanosis 23.74 11.18 41 36882 15143 50553058
Cardiac failure 23.64 11.18 13 36910 76027 50492174
Tachypnoea 23.63 11.18 40 36883 14537 50553664
Mood swings 23.55 11.18 42 36881 15912 50552289
Wound infection fungal 23.37 11.18 7 36916 120 50568081
Nightmare 23.30 11.18 42 36881 16044 50552157
Axonal neuropathy 23.23 11.18 12 36911 912 50567289
Abnormal sleep-related event 23.16 11.18 11 36912 697 50567504
Eosinophilic myocarditis 22.95 11.18 9 36914 356 50567845
Sleep paralysis 22.88 11.18 10 36913 522 50567679
Cardiac failure congestive 22.72 11.18 17 36906 84365 50483836
Open angle glaucoma 22.46 11.18 8 36915 241 50567960
Product prescribing error 22.21 11.18 48 36875 20913 50547288
Palpitations 22.08 11.18 131 36792 94375 50473826
Amphetamines positive 21.69 11.18 7 36916 155 50568046
Logorrhoea 21.61 11.18 16 36907 2308 50565893
Gastrointestinal haemorrhage 20.75 11.18 14 36909 73307 50494894
Narcolepsy 20.67 11.18 12 36911 1148 50567053
Septic shock 20.52 11.18 8 36915 57167 50511034
Protrusion tongue 20.51 11.18 8 36915 312 50567889
Hyperkalaemia 20.36 11.18 5 36918 48084 50520117
Blood pressure increased 20.16 11.18 166 36757 132966 50435235
Antiphospholipid syndrome 20.13 11.18 13 36910 1504 50566697
Long QT syndrome congenital 19.84 11.18 5 36918 43 50568158
Application site discolouration 19.60 11.18 10 36913 740 50567461
Sensory level abnormal 19.50 11.18 6 36917 113 50568088
Hallucination, tactile 19.47 11.18 7 36916 217 50567984
Renal failure 19.24 11.18 30 36893 106603 50461598
Trichotillomania 19.16 11.18 6 36917 120 50568081
Libido decreased 19.10 11.18 15 36908 2361 50565840
Discomfort 19.08 11.18 31 36892 108349 50459852
Substance abuse 19.03 11.18 19 36904 4105 50564096
Initial insomnia 19.02 11.18 21 36902 5094 50563107
Bezoar 19.00 11.18 12 36911 1336 50566865
Social avoidant behaviour 18.99 11.18 16 36907 2781 50565420
Atrial fibrillation 18.96 11.18 28 36895 101717 50466484
Pain 18.93 11.18 303 36620 578600 49989601
Compulsive lip biting 18.67 11.18 3 36920 0 50568201
Drug withdrawal syndrome 18.57 11.18 50 36873 25031 50543170
Incorrect product administration duration 18.54 11.18 28 36895 9247 50558954
Application site pain 18.45 11.18 18 36905 3780 50564421
Pyrexia 18.40 11.18 183 36740 380020 50188181
Learning disorder 18.40 11.18 9 36914 609 50567592
Renal impairment 18.20 11.18 17 36906 75644 50492557
Respiratory failure 18.08 11.18 24 36899 91157 50477044
Pleural effusion 17.67 11.18 20 36903 81434 50486767
Impaired healing 17.60 11.18 15 36908 69771 50498430
Nystagmus 17.59 11.18 21 36902 5540 50562661
Nervousness 17.42 11.18 52 36871 27599 50540602
Hypotension 17.22 11.18 101 36822 235368 50332833
Delusion 17.13 11.18 29 36894 10540 50557661
Major depression 17.02 11.18 23 36900 6861 50561340
Folliculitis 16.76 11.18 4 36919 39221 50528980
Hunger 16.72 11.18 18 36905 4245 50563956
Product complaint 16.68 11.18 30 36893 11436 50556765
Platelet count decreased 16.64 11.18 30 36893 100696 50467505
Bisexuality 16.59 11.18 3 36920 3 50568198
Thinking abnormal 16.51 11.18 27 36896 9540 50558661
Acne 16.50 11.18 41 36882 19554 50548647
Dizziness 16.50 11.18 349 36574 346020 50222181
Leukopenia 16.45 11.18 15 36908 67513 50500688
Stress 16.24 11.18 80 36843 53713 50514488
Tardive dyskinesia 16.03 11.18 23 36900 7256 50560945
C-reactive protein increased 15.91 11.18 15 36908 66459 50501742
Therapeutic response changed 15.87 11.18 9 36914 824 50567377
Foot fracture 15.84 11.18 41 36882 20050 50548151
Decreased appetite 15.57 11.18 219 36704 200704 50367497
Schizoaffective disorder bipolar type 15.48 11.18 5 36918 111 50568090
Mucosal inflammation 15.46 11.18 5 36918 40137 50528064
Hyperhidrosis 15.46 11.18 115 36808 89311 50478890
Raynaud's phenomenon 15.42 11.18 10 36913 1166 50567035
Vasospasm 15.25 11.18 8 36915 627 50567574
Grimacing 15.19 11.18 7 36916 414 50567787
Stomatitis 15.17 11.18 32 36891 101312 50466889
Congenital cystic lung 15.16 11.18 4 36919 42 50568159
Brain death 15.06 11.18 14 36909 2769 50565432
Lactic acidosis 15.06 11.18 3 36920 33352 50534849
Affect lability 15.00 11.18 25 36898 8973 50559228
Consciousness fluctuating 14.75 11.18 8 36915 671 50567530
Loss of consciousness 14.67 11.18 128 36795 104225 50463976
Knee arthroplasty 14.65 11.18 4 36919 35842 50532359
Body temperature increased 14.43 11.18 53 36870 31288 50536913
International normalised ratio increased 13.97 11.18 7 36916 43145 50525056
Hyperacusis 13.67 11.18 11 36912 1793 50566408
Formication 13.61 11.18 15 36908 3631 50564570
Heavy menstrual bleeding 13.60 11.18 33 36890 15504 50552697
Gastric bypass 13.53 11.18 10 36913 1438 50566763
Phobia 13.50 11.18 6 36917 326 50567875
Malignant neoplasm progression 13.44 11.18 18 36905 68106 50500095
Small fibre neuropathy 13.36 11.18 5 36918 174 50568027
Pelvic inflammatory disease 13.09 11.18 10 36913 1512 50566689
Treatment noncompliance 13.06 11.18 50 36873 30100 50538101
Serum serotonin decreased 12.99 11.18 3 36920 17 50568184
Cerebral artery occlusion 12.99 11.18 8 36915 852 50567349
Cleft lip and palate 12.99 11.18 6 36917 357 50567844
Regressive behaviour 12.97 11.18 4 36919 76 50568125
Diplopia 12.88 11.18 37 36886 19223 50548978
Rectal haemorrhage 12.87 11.18 6 36917 38552 50529649
Nephrogenic diabetes insipidus 12.81 11.18 8 36915 873 50567328
Herpes zoster 12.69 11.18 20 36903 70766 50497435
Muscle tightness 12.60 11.18 25 36898 10255 50557946
Mental disorder 12.59 11.18 40 36883 21951 50546250
Hepatic failure 12.47 11.18 4 36919 32279 50535922
Gastrointestinal disorder 12.39 11.18 32 36891 94424 50473777
Distractibility 12.33 11.18 6 36917 401 50567800
Poor sucking reflex 12.31 11.18 5 36918 217 50567984
Tongue biting 12.02 11.18 9 36914 1321 50566880
Horner's syndrome 11.99 11.18 3 36920 25 50568176
Seizure like phenomena 11.90 11.18 8 36915 990 50567211
Pruritus 11.89 11.18 141 36782 283427 50284774
Prehypertension 11.88 11.18 3 36920 26 50568175
Choreoathetosis 11.88 11.18 6 36917 435 50567766
Illness 11.72 11.18 42 36881 24498 50543703
Cough 11.70 11.18 116 36807 241148 50327053
Radius fracture 11.63 11.18 13 36910 3196 50565005
Neutrophil percentage increased 11.55 11.18 12 36911 2715 50565486
Hyponatraemia 11.54 11.18 34 36889 96105 50472096
Amnesia 11.46 11.18 61 36862 42199 50526002
Muscle spasms 11.45 11.18 141 36782 125412 50442789
Disease progression 11.44 11.18 34 36889 95832 50472369
Oculogyric crisis 11.40 11.18 9 36914 1428 50566773
Extrapyramidal disorder 11.39 11.18 26 36897 11744 50556457
Food craving 11.39 11.18 9 36914 1430 50566771
Petit mal epilepsy 11.37 11.18 13 36910 3276 50564925
Diaphragmalgia 11.31 11.18 4 36919 118 50568083
Status epilepticus 11.23 11.18 28 36895 13378 50554823
Ill-defined disorder 11.23 11.18 14 36909 54640 50513561
Hepatotoxicity 11.20 11.18 3 36920 27223 50540978
Drug abuser 11.19 11.18 12 36911 2816 50565385

FDA Adverse Event Reporting System (Male)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Product quality issue 895.43 13.26 430 38265 15465 29520367
No adverse event 651.11 13.26 358 38337 17120 29518712
Aggression 649.84 13.26 463 38232 35078 29500754
Tic 523.04 13.26 162 38533 1673 29534159
Agitation 424.43 13.26 423 38272 50881 29484951
Abnormal behaviour 410.22 13.26 296 38399 22831 29513001
Suicidal ideation 366.92 13.26 328 38367 34388 29501444
Product substitution issue 363.90 13.26 196 38499 8976 29526856
Irritability 348.93 13.26 264 38431 21888 29513944
Psychomotor hyperactivity 321.60 13.26 174 38521 8039 29527793
Wrong technique in product usage process 314.49 13.26 288 38407 31140 29504692
Application site erythema 306.22 13.26 112 38583 1987 29533845
Attention deficit hyperactivity disorder 253.51 13.26 99 38596 2118 29533714
Dyskinesia 253.39 13.26 210 38485 19851 29515981
Dystonia 225.33 13.26 147 38548 9602 29526230
Growth retardation 215.53 13.26 81 38614 1555 29534277
Psychotic disorder 214.27 13.26 192 38503 20162 29515670
Anxiety 211.62 13.26 391 38304 84974 29450858
Disturbance in attention 205.82 13.26 192 38503 21232 29514600
Product administration error 204.40 13.26 161 38534 14149 29521683
Acute kidney injury 201.35 13.26 50 38645 265217 29270615
Crying 197.37 13.26 109 38586 5242 29530590
Product administered at inappropriate site 186.80 13.26 74 38621 1646 29534186
Application site irritation 168.20 13.26 53 38642 581 29535251
Suicide attempt 166.47 13.26 214 38481 33896 29501936
Choreoathetosis 165.93 13.26 59 38636 961 29534871
Application site pruritus 162.84 13.26 62 38633 1235 29534597
Insomnia 158.54 13.26 355 38340 88406 29447426
Pneumonia 153.87 13.26 117 38578 320055 29215777
Incorrect product administration duration 153.67 13.26 84 38611 3957 29531875
Tachycardia 150.45 13.26 308 38387 72102 29463730
Intentional product misuse 149.94 13.26 205 38490 34456 29501376
Depression 141.47 13.26 331 38364 84816 29451016
Anger 133.30 13.26 112 38583 10778 29525054
Death 132.56 13.26 152 38543 341932 29193900
Impulsive behaviour 129.11 13.26 59 38636 1884 29533948
Hallucination, visual 127.96 13.26 126 38569 14889 29520943
Disturbance in social behaviour 117.25 13.26 53 38642 1649 29534183
Intentional overdose 116.78 13.26 193 38502 38335 29497497
Anaemia 111.87 13.26 62 38633 200889 29334943
Educational problem 111.07 13.26 37 38658 490 29535342
Drug dependence 109.24 13.26 136 38559 20845 29514987
Withdrawal syndrome 106.46 13.26 99 38596 10893 29524939
Paranoia 103.55 13.26 93 38602 9784 29526048
Trismus 103.36 13.26 54 38641 2319 29533513
Palpitations 101.05 13.26 165 38530 32439 29503393
Drug ineffective 99.75 13.26 812 37883 362358 29173474
Hallucination 99.73 13.26 196 38499 44516 29491316
Overdose 96.07 13.26 275 38420 79544 29456288
Mydriasis 94.56 13.26 72 38623 6013 29529819
Priapism 92.41 13.26 63 38632 4425 29531407
Hallucination, auditory 92.13 13.26 86 38609 9507 29526325
Serotonin syndrome 91.94 13.26 114 38581 17398 29518434
Oppositional defiant disorder 91.27 13.26 32 38663 499 29535333
Drug diversion 88.27 13.26 35 38660 780 29535052
Coronary artery dissection 87.93 13.26 25 38670 186 29535646
Depressed mood 87.84 13.26 108 38587 16340 29519492
Diarrhoea 87.74 13.26 191 38504 332507 29203325
Hypotension 85.71 13.26 77 38618 194277 29341555
Sleep disorder 84.65 13.26 130 38565 24256 29511576
Product complaint 84.09 13.26 64 38631 5341 29530491
Homicidal ideation 83.80 13.26 48 38647 2476 29533356
Somnolence 83.05 13.26 291 38404 93664 29442168
Dyspnoea 82.53 13.26 192 38503 326540 29209292
Febrile neutropenia 81.41 13.26 23 38672 112217 29423615
Hallucination, tactile 80.95 13.26 25 38670 255 29535577
Sepsis 80.82 13.26 43 38652 142639 29393193
Bruxism 80.42 13.26 40 38655 1547 29534285
Emotional disorder 80.29 13.26 60 38635 4871 29530961
Product prescribing error 78.71 13.26 107 38588 17869 29517963
Therapeutic product effect decreased 77.99 13.26 139 38556 29312 29506520
Trichotillomania 76.40 13.26 18 38677 55 29535777
Precocious puberty 75.37 13.26 20 38675 111 29535721
Feeling abnormal 74.83 13.26 197 38498 54248 29481584
Toxicity to various agents 73.33 13.26 432 38263 173229 29362603
Application site rash 73.06 13.26 30 38665 734 29535098
Mood altered 72.71 13.26 70 38625 8041 29527791
Logorrhoea 71.94 13.26 42 38653 2246 29533586
Gastrointestinal haemorrhage 70.75 13.26 10 38685 79523 29456309
Affect lability 68.25 13.26 47 38648 3355 29532477
Drug abuse 67.64 13.26 244 38451 79639 29456193
Decreased eye contact 67.48 13.26 25 38670 460 29535372
Restlessness 67.15 13.26 111 38584 22034 29513798
Renal failure 65.31 13.26 37 38658 118562 29417270
Mania 65.21 13.26 68 38627 8595 29527237
Intentional self-injury 65.21 13.26 81 38614 12380 29523452
Headache 63.50 13.26 417 38278 173590 29362242
General physical health deterioration 62.77 13.26 28 38667 102829 29433003
Product adhesion issue 62.72 13.26 33 38662 1438 29534394
Euphoric mood 61.89 13.26 51 38644 4774 29531058
Cardiac failure congestive 60.75 13.26 13 38682 76568 29459264
Pyrexia 59.01 13.26 187 38508 287435 29248397
Renal impairment 58.34 13.26 17 38678 81316 29454516
Obsessive-compulsive disorder 57.93 13.26 48 38647 4528 29531304
Oromandibular dystonia 57.23 13.26 22 38673 450 29535382
Speech disorder 57.20 13.26 107 38588 23409 29512423
Decreased appetite 57.12 13.26 355 38340 144987 29390845
Interstitial lung disease 57.01 13.26 5 38690 57713 29478119
Multiple organ dysfunction syndrome 55.98 13.26 8 38687 63108 29472724
Haemoglobin decreased 55.23 13.26 37 38658 108338 29427494
Thrombocytopenia 55.19 13.26 57 38638 134766 29401066
Apathy 54.83 13.26 53 38642 6118 29529714
Application site pain 53.26 13.26 31 38664 1648 29534184
Product administered to patient of inappropriate age 51.67 13.26 36 38659 2619 29533213
Platelet count decreased 50.36 13.26 38 38657 104634 29431198
Formication 50.36 13.26 29 38666 1511 29534321
Neutropenia 50.26 13.26 59 38636 131652 29404180
Therapeutic response unexpected 49.83 13.26 59 38636 8579 29527253
Drug screen negative 49.38 13.26 15 38680 144 29535688
Blood creatinine increased 47.62 13.26 26 38669 85076 29450756
Pancytopenia 47.14 13.26 25 38670 83143 29452689
Alice in wonderland syndrome 46.79 13.26 9 38686 5 29535827
Delusion 46.44 13.26 65 38630 11151 29524681
Product taste abnormal 46.10 13.26 24 38671 1023 29534809
Application site urticaria 45.62 13.26 12 38683 64 29535768
Gynaecomastia 45.56 13.26 55 38640 8162 29527670
Suicidal behaviour 45.43 13.26 26 38669 1339 29534493
Torticollis 45.08 13.26 24 38671 1071 29534761
Enuresis 44.68 13.26 30 38665 2054 29533778
Respiratory failure 44.54 13.26 37 38658 97094 29438738
Mood swings 44.29 13.26 51 38644 7200 29528632
Social avoidant behaviour 43.93 13.26 34 38661 2908 29532924
Oedema peripheral 41.00 13.26 45 38650 103512 29432320
Raynaud's phenomenon 40.64 13.26 15 38680 273 29535559
Autism spectrum disorder 40.59 13.26 28 38667 2004 29533828
Product colour issue 40.33 13.26 16 38679 357 29535475
Keratoconus 40.31 13.26 11 38684 69 29535763
Hyperkalaemia 40.21 13.26 15 38680 61377 29474455
Hypertension 39.78 13.26 275 38420 116339 29419493
Atrial fibrillation 38.51 13.26 49 38646 105597 29430235
Hallucinations, mixed 38.26 13.26 29 38666 2404 29533428
Heart rate increased 38.21 13.26 125 38570 38813 29497019
Drug use disorder 37.41 13.26 33 38662 3389 29532443
Hyperkinesia 36.66 13.26 24 38671 1575 29534257
Extrapyramidal disorder 36.53 13.26 57 38638 10774 29525058
Product use issue 36.01 13.26 148 38547 51296 29484536
Increased appetite 35.94 13.26 42 38653 6022 29529810
Tardive dyskinesia 35.56 13.26 39 38656 5219 29530613
Asthenia 35.49 13.26 153 38542 215097 29320735
Septic shock 35.16 13.26 19 38676 62541 29473291
Dermatillomania 34.86 13.26 9 38686 44 29535788
Treatment noncompliance 34.62 13.26 89 38606 24138 29511694
Drug tolerance 34.61 13.26 26 38669 2127 29533705
Bipolar disorder 34.48 13.26 31 38664 3264 29532568
White blood cell count decreased 34.36 13.26 35 38660 83327 29452505
Cardiac failure 34.17 13.26 32 38663 79255 29456577
Screaming 33.94 13.26 21 38674 1249 29534583
Ventricular parasystole 33.84 13.26 6 38689 0 29535832
Rebound effect 33.70 13.26 25 38670 2006 29533826
Coordination abnormal 33.67 13.26 44 38651 7070 29528762
Completed suicide 33.26 13.26 217 38478 90029 29445803
Muscle contracture 33.20 13.26 20 38675 1133 29534699
Peripheral swelling 32.13 13.26 22 38673 63717 29472115
Sleep apnoea syndrome 32.01 13.26 71 38624 17528 29518304
Affective disorder 31.90 13.26 29 38666 3097 29532735
Tremor 31.61 13.26 184 38511 73354 29462478
Arthralgia 31.26 13.26 87 38608 139530 29396302
Generalised tonic-clonic seizure 31.25 13.26 74 38621 19065 29516767
Panic attack 31.17 13.26 46 38649 8280 29527552
Joint swelling 31.06 13.26 13 38682 49617 29486215
Excessive eye blinking 30.95 13.26 14 38681 436 29535396
Incorrect dose administered 30.68 13.26 104 38591 32880 29502952
Cough 30.63 13.26 76 38619 126651 29409181
Cataplexy 30.57 13.26 12 38683 260 29535572
Nervousness 29.45 13.26 53 38642 11253 29524579
Pain 29.38 13.26 120 38575 171312 29364520
Pre-existing condition improved 29.28 13.26 24 38671 2229 29533603
Phobia 29.06 13.26 10 38685 147 29535685
Hyperhidrosis 28.72 13.26 163 38532 64377 29471455
Peripheral coldness 28.63 13.26 38 38657 6198 29529634
Infusion related reaction 28.27 13.26 11 38684 43875 29491957
Sympathomimetic effect 28.20 13.26 5 38690 0 29535832
Onychophagia 27.97 13.26 8 38687 61 29535771
Gilbert's syndrome 27.87 13.26 7 38688 30 29535802
Melaena 27.52 13.26 4 38691 31172 29504660
Chronic kidney disease 27.24 13.26 7 38688 36409 29499423
Malignant neoplasm progression 27.17 13.26 34 38661 73825 29462007
Tourette's disorder 27.00 13.26 8 38687 70 29535762
Metabolic acidosis 26.76 13.26 8 38687 37654 29498178
Application site erosion 26.70 13.26 8 38687 73 29535759
Drug withdrawal syndrome 26.66 13.26 67 38628 17917 29517915
Pleural effusion 26.56 13.26 33 38662 71875 29463957
Infection 26.53 13.26 37 38658 76714 29459118
Hyponatraemia 26.08 13.26 30 38665 67603 29468229
International normalised ratio increased 25.63 13.26 13 38682 44359 29491473
Self-injurious ideation 25.53 13.26 19 38676 1532 29534300
Device difficult to use 25.15 13.26 19 38676 1567 29534265
Disease progression 24.96 13.26 43 38652 81873 29453959
Change in sustained attention 24.74 13.26 5 38690 5 29535827
Product dispensing error 24.56 13.26 33 38662 5447 29530385
Mental disorder 24.53 13.26 53 38642 12852 29522980
Dysphemia 24.40 13.26 18 38677 1432 29534400
Rheumatoid arthritis 24.40 13.26 6 38689 32146 29503686
Seizure 24.12 13.26 206 38489 92917 29442915
Dermo-hypodermitis 24.11 13.26 10 38685 251 29535581
Fall 23.95 13.26 135 38560 177043 29358789
Cerebral congestion 23.83 13.26 6 38689 26 29535806
Polydipsia psychogenic 23.67 13.26 8 38687 111 29535721
Multiple cardiac defects 23.55 13.26 7 38688 62 29535770
Substance use disorder 23.50 13.26 10 38685 268 29535564
Oxygen saturation decreased 23.33 13.26 15 38680 44922 29490910
Delayed puberty 23.19 13.26 9 38686 189 29535643
Stereotypy 23.14 13.26 13 38682 646 29535186
Pain in extremity 23.11 13.26 71 38624 110362 29425470
Somnambulism 22.94 13.26 23 38672 2775 29533057
Substance-induced psychotic disorder 22.84 13.26 17 38678 1371 29534461
Neuropathy peripheral 22.83 13.26 36 38659 70991 29464841
Erythema 22.75 13.26 40 38655 75566 29460266
Distractibility 22.71 13.26 10 38685 292 29535540
Adhesive tape use 22.56 13.26 4 38691 0 29535832
Blood creatine phosphokinase increased 22.45 13.26 109 38586 40535 29495297
Weight gain poor 22.44 13.26 14 38681 845 29534987
Sudden death 22.44 13.26 54 38641 14056 29521776
Illusion 22.37 13.26 13 38682 689 29535143
Regressive behaviour 22.21 13.26 6 38689 36 29535796
Acute psychosis 21.99 13.26 18 38677 1669 29534163
Tongue spasm 21.94 13.26 6 38689 38 29535794
Blood urea increased 21.82 13.26 5 38690 28107 29507725
Petit mal epilepsy 21.63 13.26 22 38673 2700 29533132
Colitis 21.55 13.26 7 38688 31241 29504591
Constipation 21.41 13.26 77 38618 114083 29421749
Dehydration 21.13 13.26 78 38617 114670 29421162
Product residue present 21.05 13.26 21 38674 2518 29533314
Oculogyric crisis 20.91 13.26 16 38679 1345 29534487
Application site dryness 20.72 13.26 6 38689 48 29535784
Erection increased 20.66 13.26 11 38684 491 29535341
Negativism 20.64 13.26 10 38685 365 29535467
Lactic acidosis 20.46 13.26 7 38688 30240 29505592
Migraine 20.23 13.26 48 38647 12382 29523450
Mucosal inflammation 20.21 13.26 8 38687 31587 29504245
Muscle twitching 20.11 13.26 37 38658 7989 29527843
Coronary artery disease 20.03 13.26 17 38678 44173 29491659
Productive cough 19.86 13.26 8 38687 31251 29504581
Plasma cell myeloma 19.80 13.26 12 38683 37103 29498729
Renal disorder 19.71 13.26 3 38692 22592 29513240
Liver disorder 19.52 13.26 6 38689 27743 29508089
Suspiciousness 19.39 13.26 9 38686 298 29535534
Ascites 19.32 13.26 12 38683 36607 29499225
School refusal 19.28 13.26 5 38690 25 29535807
Substance abuse 19.21 13.26 33 38662 6754 29529078
Panic reaction 19.20 13.26 15 38680 1300 29534532
Application site scab 19.19 13.26 6 38689 64 29535768
Performance status decreased 19.13 13.26 24 38671 3703 29532129
Scoliosis 19.03 13.26 19 38676 2281 29533551
Incorrect route of product administration 18.99 13.26 43 38652 10758 29525074
Poisoning 18.94 13.26 41 38654 9952 29525880
C-reactive protein increased 18.90 13.26 18 38677 44245 29491587
Accidental exposure to product by child 18.82 13.26 15 38680 1339 29534493
Hypokalaemia 18.57 13.26 23 38672 50180 29485652
Cholestasis 18.56 13.26 4 38691 23458 29512374
Drug resistance 18.47 13.26 3 38692 21537 29514295
Chorea 18.39 13.26 13 38682 968 29534864
Shock 18.31 13.26 3 38692 21401 29514431
Neutrophil count decreased 18.27 13.26 18 38677 43549 29492283
Pneumonitis 18.11 13.26 7 38688 28037 29507795
Abdominal distension 18.10 13.26 20 38675 45891 29489941
Pericardial effusion 18.08 13.26 3 38692 21205 29514627
Drooling 18.03 13.26 21 38674 3000 29532832
Fear 18.02 13.26 39 38656 9465 29526367
Hepatic function abnormal 17.92 13.26 15 38680 39244 29496588
Off label use 17.80 13.26 517 38178 300283 29235549
Hypocalcaemia 17.45 13.26 3 38692 20662 29515170
Tri-iodothyronine increased 17.38 13.26 5 38690 39 29535793
Insulin resistance 17.31 13.26 10 38685 524 29535308
Physical assault 17.22 13.26 13 38682 1071 29534761
Urinary incontinence 17.15 13.26 54 38641 16427 29519405
Libido increased 16.96 13.26 11 38684 710 29535122
Cardiac contusion 16.92 13.26 3 38692 0 29535832
Limb girth decreased 16.92 13.26 3 38692 0 29535832
Anorexia nervosa 16.92 13.26 3 38692 0 29535832
Rash 16.81 13.26 163 38532 189656 29346176
Testicular failure 16.75 13.26 5 38690 45 29535787
Dyspnoea exertional 16.58 13.26 14 38681 36476 29499356
Depersonalisation/derealisation disorder 16.53 13.26 10 38685 571 29535261
Amnesia 16.51 13.26 66 38629 22577 29513255
Weight increased 16.50 13.26 163 38532 76504 29459328
Lower respiratory tract infection 16.48 13.26 7 38688 26495 29509337
Poor quality product administered 16.48 13.26 15 38680 1604 29534228
Drug reaction with eosinophilia and systemic symptoms 16.47 13.26 8 38687 27984 29507848
Haematoma 16.36 13.26 5 38690 23207 29512625
Sydenham's chorea 16.35 13.26 4 38691 15 29535817
Idiopathic intracranial hypertension 16.31 13.26 10 38685 585 29535247
Vision blurred 16.27 13.26 99 38596 40077 29495755
Urinary tract infection 16.23 13.26 45 38650 72309 29463523
Hypoxia 16.21 13.26 23 38672 47356 29488476
Strabismus 16.17 13.26 14 38681 1402 29534430
Pulmonary embolism 16.15 13.26 49 38646 76485 29459347
Application site ulcer 16.14 13.26 4 38691 16 29535816
Wolff-Parkinson-White syndrome 16.10 13.26 7 38688 198 29535634
Opisthotonus 16.06 13.26 9 38686 445 29535387
Acute respiratory distress syndrome 16.06 13.26 5 38690 22930 29512902
Rectal haemorrhage 16.02 13.26 13 38682 34536 29501296
Vasospasm 15.93 13.26 8 38687 316 29535516
Bone marrow failure 15.91 13.26 8 38687 27441 29508391
Therapeutic response changed 15.90 13.26 8 38687 317 29535515
Stubbornness 15.77 13.26 4 38691 18 29535814
Product dose omission issue 15.73 13.26 194 38501 96189 29439643
Meningitis staphylococcal 15.69 13.26 5 38690 57 29535775
Accommodation disorder 15.57 13.26 7 38688 215 29535617
Daydreaming 15.56 13.26 9 38686 473 29535359
Major depression 15.54 13.26 22 38673 3813 29532019
Application site discolouration 15.51 13.26 7 38688 217 29535615
Poor quality sleep 15.25 13.26 31 38664 7202 29528630
Social anxiety disorder 15.07 13.26 7 38688 232 29535600
Hypoglycaemia 15.07 13.26 25 38670 48321 29487511
Parasomnia 14.94 13.26 8 38687 361 29535471
Psychopathic personality 14.85 13.26 3 38692 3 29535829
Stomatitis 14.81 13.26 16 38679 37097 29498735
Injection site abscess 14.71 13.26 10 38685 699 29535133
Eye movement disorder 14.68 13.26 21 38674 3675 29532157
Thrombosis 14.62 13.26 21 38674 43024 29492808
Lung disorder 14.61 13.26 11 38684 30351 29505481
Inappropriate affect 14.53 13.26 9 38686 536 29535296
Stress cardiomyopathy 14.52 13.26 14 38681 1610 29534222
Initial insomnia 14.45 13.26 18 38677 2757 29533075
Blood growth hormone decreased 14.41 13.26 4 38691 27 29535805
Blood thyroid stimulating hormone increased 14.38 13.26 19 38676 3086 29532746
Myocardial infarction 14.36 13.26 85 38610 110211 29425621
Frustration tolerance decreased 14.02 13.26 16 38679 2236 29533596
Epiphyses delayed fusion 13.99 13.26 3 38692 5 29535827
Chronic obstructive pulmonary disease 13.89 13.26 20 38675 40935 29494897
COVID-19 13.85 13.26 16 38679 35998 29499834
Electrocardiogram T wave inversion 13.83 13.26 15 38680 1982 29533850
Back pain 13.76 13.26 78 38617 102206 29433626
Sedation 13.72 13.26 52 38643 17353 29518479
Personality change 13.72 13.26 23 38672 4615 29531217
Schizotypal personality disorder 13.63 13.26 3 38692 6 29535826
Sexual dysfunction 13.57 13.26 26 38669 5788 29530044
Prescribed overdose 13.56 13.26 33 38662 8650 29527182
Haemoptysis 13.54 13.26 12 38683 30538 29505294
Therapeutic product effect increased 13.47 13.26 9 38686 611 29535221
Dependence 13.40 13.26 11 38684 1024 29534808
Nightmare 13.37 13.26 39 38656 11378 29524454
Compulsions 13.35 13.26 6 38689 184 29535648
Pressure of speech 13.33 13.26 8 38687 450 29535382
Dysphoria 13.26 13.26 15 38680 2077 29533755

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Aggression 685.75 11.32 451 54997 45781 64397503
Agitation 598.97 11.32 541 54907 87826 64355458
Product substitution issue 511.43 11.32 267 55181 17594 64425690
Suicidal ideation 501.92 11.32 433 55015 66109 64377175
Tic 494.94 11.32 153 55295 2466 64440818
Abnormal behaviour 452.75 11.32 309 55139 33313 64409971
Product quality issue 427.85 11.32 285 55163 29514 64413770
Irritability 416.58 11.32 304 55144 36442 64406842
No adverse event 318.50 11.32 234 55214 28327 64414957
Attention deficit hyperactivity disorder 298.83 11.32 106 55342 2664 64440620
Tachycardia 289.92 11.32 486 54962 149093 64294191
Psychomotor hyperactivity 284.79 11.32 169 55279 14282 64429002
Anxiety 283.68 11.32 572 54876 202077 64241207
Dystonia 269.69 11.32 180 55268 18685 64424599
Dyskinesia 268.19 11.32 242 55206 39146 64404138
Disturbance in attention 234.78 11.32 229 55219 40845 64402439
Psychotic disorder 213.16 11.32 201 55247 34377 64408907
Suicide attempt 211.04 11.32 282 55166 70725 64372559
Depression 204.30 11.32 472 54976 182819 64260465
Toxicity to various agents 194.95 11.32 720 54728 362793 64080491
Intentional overdose 185.87 11.32 301 55147 89643 64353641
Insomnia 185.85 11.32 477 54971 197359 64245925
Acute kidney injury 173.36 11.32 85 55363 449155 63994129
Mydriasis 171.89 11.32 126 55322 15186 64428098
Choreoathetosis 166.12 11.32 58 55390 1389 64441895
Overdose 163.74 11.32 398 55050 159168 64284116
Precocious puberty 161.25 11.32 40 55408 266 64443018
Intentional product misuse 160.45 11.32 250 55198 72045 64371239
Educational problem 154.98 11.32 41 55407 363 64442921
Hallucination, visual 154.95 11.32 153 55295 27681 64415603
Application site erythema 151.27 11.32 76 55372 4613 64438671
Crying 149.79 11.32 130 55318 19960 64423324
Growth retardation 146.89 11.32 54 55394 1507 64441777
Hallucination 144.14 11.32 239 55209 72549 64370735
Hallucination, auditory 139.38 11.32 116 55332 16823 64426461
Product administration error 128.64 11.32 138 55310 27505 64415779
Impulsive behaviour 128.56 11.32 57 55391 2606 64440678
Anger 127.86 11.32 107 55341 15634 64427650
Intentional self-injury 123.01 11.32 138 55310 28906 64414378
Anaemia 119.05 11.32 91 55357 378589 64064695
Wrong technique in product usage process 118.91 11.32 206 55242 64768 64378516
Drug abuse 118.86 11.32 314 55134 132060 64311224
Tremor 117.59 11.32 336 55112 147894 64295390
Withdrawal syndrome 115.92 11.32 121 55327 23371 64419913
Serotonin syndrome 113.58 11.32 154 55294 39128 64404156
Diarrhoea 112.88 11.32 288 55160 722416 63720868
Paranoia 112.30 11.32 101 55347 16251 64427033
Trismus 108.96 11.32 62 55386 4839 64438445
Drug dependence 107.76 11.32 138 55310 33174 64410110
Priapism 104.11 11.32 56 55392 3914 64439370
Product administered at inappropriate site 102.06 11.32 51 55397 3059 64440225
Apathy 100.98 11.32 81 55367 11151 64432133
Muscle contracture 100.62 11.32 45 55403 2100 64441184
Hallucination, tactile 98.83 11.32 30 55418 453 64442831
Bruxism 97.51 11.32 52 55396 3572 64439712
Joint swelling 97.20 11.32 32 55416 215350 64227934
Somnolence 94.67 11.32 386 55062 203259 64240025
Oppositional defiant disorder 94.39 11.32 29 55419 457 64442827
Pneumonia 94.36 11.32 214 55234 559362 63883922
Mania 93.38 11.32 91 55357 16195 64427089
Mood altered 92.97 11.32 90 55358 15889 64427395
Application site irritation 90.06 11.32 38 55410 1538 64441746
Completed suicide 88.68 11.32 405 55043 224009 64219275
Incorrect product administration duration 86.94 11.32 70 55378 9688 64433596
Death 86.82 11.32 178 55270 482527 63960757
Cataplexy 86.60 11.32 31 55417 800 64442484
Enuresis 86.43 11.32 44 55404 2746 64440538
Euphoric mood 84.93 11.32 59 55389 6532 64436752
Restlessness 84.65 11.32 135 55313 39650 64403634
Homicidal ideation 82.78 11.32 45 55403 3212 64440072
Obsessive-compulsive disorder 81.21 11.32 51 55397 4767 64438517
Affect lability 81.17 11.32 65 55383 8925 64434359
Febrile neutropenia 79.35 11.32 31 55417 187626 64255658
Dyspnoea 78.51 11.32 335 55113 718339 63724945
Chorea 78.28 11.32 37 55411 1963 64441321
Peripheral swelling 76.90 11.32 42 55406 209111 64234173
Coronary artery dissection 76.56 11.32 29 55419 881 64442403
Emotional disorder 75.21 11.32 72 55376 12535 64430749
Trichotillomania 72.45 11.32 19 55429 162 64443122
Synovitis 72.21 11.32 3 55445 99087 64344197
Logorrhoea 71.02 11.32 44 55404 4015 64439269
Drug diversion 70.32 11.32 29 55419 1107 64442177
Decreased eye contact 70.27 11.32 26 55422 739 64442545
Depressed mood 69.81 11.32 126 55322 40886 64402398
General physical health deterioration 68.24 11.32 46 55402 204379 64238905
Arthralgia 66.72 11.32 179 55269 442081 64001203
Rheumatoid arthritis 66.44 11.32 29 55419 164265 64279019
Palpitations 65.26 11.32 218 55230 104270 64339014
Neutropenia 65.05 11.32 66 55382 239558 64203726
Sepsis 64.19 11.32 62 55386 230279 64213005
Application site pruritus 63.54 11.32 39 55409 3500 64439784
Feeling abnormal 63.42 11.32 255 55193 133347 64309937
Heart rate increased 62.63 11.32 207 55241 98468 64344816
Interstitial lung disease 62.24 11.32 6 55442 97726 64345558
Headache 60.98 11.32 709 54739 528758 63914526
Contraindicated product administered 60.49 11.32 10 55438 107819 64335465
Delusion 60.42 11.32 76 55372 17938 64425346
Muscle twitching 60.33 11.32 78 55370 18920 64424364
Hypotension 59.89 11.32 151 55297 380823 64062461
Thrombocytopenia 59.21 11.32 63 55385 223738 64219546
Gastrointestinal haemorrhage 59.06 11.32 20 55428 132292 64310992
Infusion related reaction 59.04 11.32 34 55414 164433 64278851
Cardiac failure congestive 57.83 11.32 20 55428 130560 64312724
Arthropathy 56.27 11.32 17 55431 120950 64322334
Tardive dyskinesia 55.86 11.32 53 55395 9125 64434159
Panic attack 54.36 11.32 78 55370 20875 64422409
Extrapyramidal disorder 54.01 11.32 75 55373 19477 64423807
Haemoglobin decreased 53.76 11.32 53 55395 195010 64248274
Multiple organ dysfunction syndrome 53.46 11.32 11 55437 101402 64341882
Gynaecomastia 53.26 11.32 43 55405 5973 64437311
Lower respiratory tract infection 52.57 11.32 9 55439 94605 64348679
Seizure 52.21 11.32 282 55166 166610 64276674
Pulmonary malformation 51.94 11.32 14 55434 134 64443150
Renal impairment 51.25 11.32 26 55422 134991 64308293
Swelling 50.89 11.32 38 55410 160180 64283104
Somnambulism 50.35 11.32 39 55409 5102 64438182
Product taste abnormal 49.04 11.32 27 55421 1976 64441308
Oromandibular dystonia 48.81 11.32 21 55427 892 64442392
Rapid eye movement sleep behaviour disorder 48.29 11.32 16 55432 325 64442959
Pancytopenia 48.14 11.32 32 55416 143277 64300007
Sleep disorder 47.91 11.32 136 55312 59573 64383711
Infection 47.83 11.32 53 55395 184827 64258457
Social anxiety disorder 47.70 11.32 17 55431 433 64442851
Drug intolerance 46.36 11.32 56 55392 187936 64255348
Sleep apnoea syndrome 46.18 11.32 88 55360 29744 64413540
Affective disorder 45.88 11.32 41 55407 6539 64436745
Platelet count decreased 45.71 11.32 46 55402 167665 64275619
Social avoidant behaviour 45.57 11.32 35 55413 4522 64438762
Drug hypersensitivity 44.97 11.32 85 55363 237730 64205554
Alice in wonderland syndrome 44.95 11.32 10 55438 38 64443246
Renal failure 44.93 11.32 54 55394 181634 64261650
Keratoconus 44.76 11.32 11 55437 70 64443214
Treatment failure 43.58 11.32 23 55425 116793 64326491
Decreased appetite 43.36 11.32 400 55048 280889 64162395
Product administered to patient of inappropriate age 43.11 11.32 34 55414 4567 64438717
Respiratory failure 43.03 11.32 45 55403 161138 64282146
Pyrexia 42.79 11.32 293 55155 558351 63884933
Hallucinations, mixed 42.77 11.32 38 55410 6014 64437270
Increased appetite 42.59 11.32 48 55400 10098 64433186
Ventricular parasystole 42.42 11.32 7 55441 0 64443284
Hyperkalaemia 42.24 11.32 17 55431 101112 64342172
Therapeutic response unexpected 42.23 11.32 62 55386 16939 64426345
Drug withdrawal syndrome 42.05 11.32 87 55361 31204 64412080
Systemic lupus erythematosus 41.78 11.32 8 55440 77604 64365680
Application site rash 41.51 11.32 24 55424 1930 64441354
Hyperhidrosis 41.05 11.32 214 55234 124706 64318578
Mood swings 40.95 11.32 62 55386 17406 64425878
Hyperkinesia 40.54 11.32 26 55422 2520 64440764
Cardiac failure 40.01 11.32 33 55415 132340 64310944
Disturbance in social behaviour 39.19 11.32 30 55418 3857 64439427
Hypertension 39.10 11.32 367 55081 258894 64184390
Atrial fibrillation 39.05 11.32 54 55394 171035 64272249
Generalised tonic-clonic seizure 38.24 11.32 97 55351 39760 64403524
Change in sustained attention 38.09 11.32 7 55441 6 64443278
Speech disorder 37.56 11.32 109 55339 48332 64394952
Suicidal behaviour 37.56 11.32 26 55422 2861 64440423
Feeling jittery 37.48 11.32 46 55402 10589 64432695
Lung cyst 36.87 11.32 11 55437 156 64443128
Glossodynia 36.28 11.32 6 55442 64690 64378594
Pain 35.90 11.32 304 55144 553207 63890077
Nervousness 34.92 11.32 78 55370 29478 64413806
Cough 34.60 11.32 138 55310 302010 64141274
Petit mal epilepsy 34.38 11.32 31 55417 5001 64438283
Torticollis 34.09 11.32 22 55426 2155 64441129
Product adhesion issue 34.02 11.32 23 55425 2436 64440848
Adhesive tape use 33.93 11.32 6 55442 3 64443281
Excessive eye blinking 33.67 11.32 18 55430 1242 64442042
Septic shock 33.48 11.32 25 55423 105412 64337872
Mobility decreased 33.37 11.32 16 55432 85824 64357460
Oculogyric crisis 33.36 11.32 23 55425 2515 64440769
Incorrect dose administered 32.92 11.32 121 55327 60644 64382640
Sudden death 31.99 11.32 60 55388 20036 64423248
Treatment noncompliance 31.96 11.32 96 55352 43386 64399898
Therapeutic response changed 31.89 11.32 16 55432 968 64442316
Peripheral coldness 31.54 11.32 48 55400 13536 64429748
Rash 31.47 11.32 248 55200 458301 63984983
Raynaud's phenomenon 31.40 11.32 16 55432 1000 64442284
Drug use disorder 31.33 11.32 32 55416 6022 64437262
Stereotypy 31.19 11.32 15 55433 827 64442457
School refusal 30.98 11.32 7 55441 29 64443255
Pleural effusion 30.87 11.32 38 55410 126521 64316763
Substance abuse 30.84 11.32 39 55409 9253 64434031
Screaming 30.77 11.32 25 55423 3504 64439780
Maternal exposure during breast feeding 30.65 11.32 20 55428 1996 64441288
Solar urticaria 30.53 11.32 8 55440 68 64443216
Oedema peripheral 30.24 11.32 87 55361 210230 64233054
Negative thoughts 30.18 11.32 17 55431 1301 64441983
Bipolar disorder 30.13 11.32 33 55415 6728 64436556
Blister 30.11 11.32 16 55432 80951 64362333
Formication 30.08 11.32 27 55421 4330 64438954
Melaena 29.95 11.32 5 55443 53543 64389741
Drug tolerance 29.40 11.32 31 55417 6054 64437230
Delayed puberty 29.11 11.32 9 55439 145 64443139
International normalised ratio increased 28.92 11.32 16 55432 79151 64364133
Pericarditis 28.68 11.32 9 55439 62507 64380777
Wound 28.60 11.32 15 55433 76462 64366822
Parasomnia 28.50 11.32 12 55436 483 64442801
Malignant neoplasm progression 28.48 11.32 33 55415 112838 64330446
Substance use disorder 28.38 11.32 11 55437 356 64442928
Hyperventilation 28.10 11.32 32 55416 6808 64436476
Pre-existing condition improved 28.03 11.32 27 55421 4735 64438549
Tachypnoea 27.96 11.32 67 55381 26504 64416780
Blood creatine phosphokinase increased 27.94 11.32 112 55336 58446 64384838
Blood creatinine increased 27.94 11.32 46 55402 135736 64307548
Nightmare 27.77 11.32 58 55390 20935 64422349
Protrusion tongue 27.54 11.32 11 55437 386 64442898
Application site discolouration 27.20 11.32 13 55435 707 64442577
Lactation disorder 27.20 11.32 9 55439 182 64443102
Product prescribing error 27.00 11.32 79 55369 35190 64408094
Body temperature increased 26.99 11.32 81 55367 36585 64406699
Migraine 26.87 11.32 116 55332 62561 64380723
Coordination abnormal 26.77 11.32 47 55401 14917 64428367
Vasospasm 26.77 11.32 14 55434 924 64442360
Drug reaction with eosinophilia and systemic symptoms 26.35 11.32 7 55441 54210 64389074
Lactic acidosis 26.17 11.32 10 55438 61400 64381884
Product complaint 26.02 11.32 41 55407 11913 64431371
Erythema 25.72 11.32 79 55369 186991 64256293
Hypersomnia 25.53 11.32 54 55394 19663 64423621
Coronary artery disease 25.49 11.32 10 55438 60423 64382861
Hyponatraemia 25.49 11.32 56 55392 148283 64295001
Vision blurred 25.16 11.32 148 55300 90168 64353116
Asthenia 25.13 11.32 241 55207 427803 64015481
Application site urticaria 25.11 11.32 9 55439 233 64443051
Erection increased 25.01 11.32 10 55438 352 64442932
Strabismus 24.92 11.32 18 55430 2119 64441165
Rectal haemorrhage 24.83 11.32 11 55437 61806 64381478
White blood cell count decreased 24.40 11.32 63 55385 157774 64285510
Optic disc haemorrhage 24.39 11.32 7 55441 86 64443198
Urine amphetamine negative 24.24 11.32 4 55444 0 64443284
Cardiac contusion 24.24 11.32 4 55444 0 64443284
Testicular failure 24.24 11.32 4 55444 0 64443284
Maternal exposure during pregnancy 24.22 11.32 28 55420 95856 64347428
Hepatotoxicity 24.05 11.32 3 55445 39959 64403325
Mental disorder 23.96 11.32 63 55385 26382 64416902
Eye movement disorder 23.95 11.32 30 55418 7049 64436235
Poisoning 23.92 11.32 56 55392 21823 64421461
Autism spectrum disorder 23.91 11.32 13 55435 928 64442356
Meningitis streptococcal 23.90 11.32 8 55440 168 64443116
Mucosal inflammation 23.81 11.32 12 55436 62572 64380712
Bone marrow failure 23.67 11.32 6 55442 47946 64395338
Multiple sclerosis relapse 23.20 11.32 83 55365 41052 64402232
Status epilepticus 23.20 11.32 55 55393 21608 64421676
Exposure via breast milk 23.09 11.32 12 55436 782 64442502
Abdominal discomfort 22.99 11.32 80 55368 182242 64261042
Wound infection fungal 22.97 11.32 8 55440 190 64443094
Memory impairment 22.97 11.32 139 55309 85543 64357741
Dehydration 22.94 11.32 102 55346 216661 64226623
Substance-induced psychotic disorder 22.93 11.32 19 55429 2736 64440548
Product colour issue 22.62 11.32 11 55437 622 64442662
Polydipsia psychogenic 22.59 11.32 8 55440 200 64443084
Scoliosis 22.56 11.32 27 55421 6055 64437229
Hepatic enzyme increased 22.37 11.32 49 55399 129894 64313390
Poor quality product administered 22.35 11.32 20 55428 3195 64440089
Tachyphrenia 22.33 11.32 16 55432 1860 64441424
Hangover 22.14 11.32 16 55432 1885 64441399
Pre-eclampsia 22.03 11.32 27 55421 6204 64437080
Compulsions 21.99 11.32 9 55439 337 64442947
Initial insomnia 21.91 11.32 26 55422 5778 64437506
Product dispensing error 21.84 11.32 37 55411 11413 64431871
Sympathomimetic effect 21.59 11.32 6 55442 65 64443219
Disease progression 21.56 11.32 57 55391 141623 64301661
Cyanosis 21.33 11.32 54 55394 22101 64421183
Dermo-hypodermitis 21.15 11.32 10 55438 531 64442753
Hunger 21.02 11.32 22 55426 4259 64439025
Wolff-Parkinson-White syndrome 20.73 11.32 8 55440 256 64443028
C-reactive protein increased 20.61 11.32 31 55417 94878 64348406
Tongue spasm 20.52 11.32 6 55442 79 64443205
Oxygen saturation decreased 20.51 11.32 38 55410 107138 64336146
Weight gain poor 20.50 11.32 11 55437 765 64442519
Self-injurious ideation 20.49 11.32 19 55429 3178 64440106
Upper gastrointestinal haemorrhage 20.35 11.32 3 55445 35217 64408067
Panic reaction 20.32 11.32 21 55427 4006 64439278
Psychiatric symptom 20.30 11.32 26 55422 6247 64437037
Abdominal distension 20.23 11.32 32 55416 95962 64347322
Drug screen negative 20.22 11.32 8 55440 274 64443010
Splenic infarction 20.18 11.32 19 55429 3238 64440046
Onychophagia 20.05 11.32 6 55442 86 64443198
Incorrect route of product administration 19.60 11.32 54 55394 23244 64420040
Burnout syndrome 19.53 11.32 8 55440 300 64442984
Narcolepsy 19.53 11.32 12 55436 1079 64442205
Distractibility 19.46 11.32 10 55438 636 64442648
Hepatic function abnormal 19.46 11.32 16 55432 64297 64378987
Respiratory tract malformation 19.46 11.32 5 55443 39 64443245
Osteoporosis 19.40 11.32 6 55442 42074 64401210
Chronic kidney disease 19.35 11.32 13 55435 57906 64385378
Grimacing 19.19 11.32 10 55438 655 64442629
Hypocalcaemia 19.17 11.32 6 55442 41747 64401537
Stomatitis 19.13 11.32 41 55407 109564 64333720
Akathisia 19.12 11.32 35 55413 11475 64431809
Cataract subcapsular 19.10 11.32 11 55437 878 64442406
Sinus tachycardia 19.06 11.32 66 55382 32122 64411162
Thinking abnormal 19.02 11.32 35 55413 11521 64431763
Dermatillomania 18.98 11.32 7 55441 197 64443087
Sleep-related eating disorder 18.95 11.32 10 55438 672 64442612
Hypoglycaemia 18.91 11.32 30 55418 89862 64353422
Cerebral congestion 18.83 11.32 5 55443 45 64443239
Agranulocytosis 18.46 11.32 5 55443 38224 64405060
Long QT syndrome congenital 18.44 11.32 5 55443 49 64443235
Atrioventricular block second degree 18.19 11.32 25 55423 6429 64436855
Limb girth decreased 18.18 11.32 3 55445 0 64443284
Herpes zoster 18.05 11.32 25 55423 79162 64364122
Poor quality sleep 18.05 11.32 46 55402 18905 64424379
Open angle glaucoma 17.93 11.32 8 55440 371 64442913
Phobia 17.83 11.32 8 55440 376 64442908
Illusion 17.80 11.32 13 55435 1557 64441727
Disinhibition 17.70 11.32 15 55433 2228 64441056
Inflammation 17.68 11.32 18 55430 65282 64378002
Sensory level abnormal 17.62 11.32 6 55442 133 64443151
Loss of consciousness 17.56 11.32 200 55248 148165 64295119
Fear 17.21 11.32 47 55401 20124 64423160
Dysphoria 17.14 11.32 20 55428 4368 64438916
Hypnagogic hallucination 17.13 11.32 6 55442 145 64443139
Amnesia 16.75 11.32 84 55364 48185 64395099
Anaphylactic shock 16.59 11.32 3 55445 30325 64412959
Product residue present 16.53 11.32 17 55431 3225 64440059
Hepatic failure 16.49 11.32 14 55434 55380 64387904
Oedema 16.37 11.32 34 55414 91901 64351383
Accidental exposure to product by child 16.37 11.32 15 55433 2470 64440814
Opisthotonus 16.30 11.32 9 55439 662 64442622
Hypoxia 16.21 11.32 32 55416 88117 64355167
Tourette's disorder 16.14 11.32 5 55443 81 64443203
Chronic fatigue syndrome 16.11 11.32 11 55437 1184 64442100
Bisexuality 16.10 11.32 3 55445 3 64443281
Neutrophil count decreased 16.02 11.32 26 55422 77170 64366114
Prescribed overdose 16.00 11.32 46 55402 20285 64422999
Psoriasis 15.98 11.32 23 55425 71680 64371604
Regressive behaviour 15.98 11.32 5 55443 84 64443200
Toxic epidermal necrolysis 15.92 11.32 6 55442 37160 64406124
Major depression 15.90 11.32 26 55422 7790 64435494
Pruritus 15.82 11.32 182 55266 312218 64131066
Hyperphagia 15.75 11.32 14 55434 2217 64441067
Pericardial effusion 15.74 11.32 7 55441 39247 64404037
Tooth discolouration 15.72 11.32 10 55438 955 64442329
Concussion 15.61 11.32 26 55422 7912 64435372
Nystagmus 15.60 11.32 28 55420 9040 64434244
Bundle branch block right 15.53 11.32 30 55418 10239 64433045
Brain oedema 15.53 11.32 48 55400 22027 64421257
Antiphospholipid syndrome 15.49 11.32 12 55436 1570 64441714
Osteoarthritis 15.46 11.32 19 55429 63317 64379967
Injection site pain 15.34 11.32 47 55401 111361 64331923
Hyperacusis 15.34 11.32 13 55435 1932 64441352
Negativism 15.26 11.32 9 55439 751 64442533
Meningitis staphylococcal 15.21 11.32 5 55443 99 64443185
Hypokalaemia 15.02 11.32 54 55394 121849 64321435
Sleep paralysis 14.99 11.32 8 55440 550 64442734
Eosinophilia 14.94 11.32 7 55441 38069 64405215
Substance abuser 14.89 11.32 5 55443 106 64443178
Staring 14.82 11.32 14 55434 2396 64440888
Application site erosion 14.80 11.32 6 55442 219 64443065
Wrong product administered 14.80 11.32 25 55423 7695 64435589
Ascites 14.71 11.32 19 55429 61982 64381302
Product use issue 14.71 11.32 197 55251 151518 64291766
Livedo reticularis 14.69 11.32 17 55431 3680 64439604
Injection site abscess 14.56 11.32 11 55437 1387 64441897
Insulin resistance 14.53 11.32 10 55438 1090 64442194
Plasma cell myeloma 14.52 11.32 11 55437 46064 64397220
Myelodysplastic syndrome 14.51 11.32 3 55445 27576 64415708
Acute psychosis 14.48 11.32 17 55431 3735 64439549
Leukopenia 14.45 11.32 42 55406 101200 64342084
Sudden onset of sleep 14.41 11.32 8 55440 595 64442689
Talipes 14.39 11.32 5 55443 118 64443166
Application site pain 14.37 11.32 18 55430 4230 64439054
Eosinophilic myocarditis 14.31 11.32 9 55439 843 64442441
Surgery 14.29 11.32 55 55393 28158 64415126
Epiphyses delayed fusion 14.29 11.32 3 55445 8 64443276
Hypertonia 14.19 11.32 22 55426 6303 64436981
Congestive cardiomyopathy 14.18 11.32 29 55419 10315 64432969
Hyperglycaemia 14.14 11.32 19 55429 60949 64382335
Schizotypal personality disorder 14.03 11.32 3 55445 9 64443275
Hepatocellular injury 14.00 11.32 11 55437 45224 64398060
Electrocardiogram QRS complex prolonged 13.97 11.32 27 55421 9217 64434067
Schizoaffective disorder bipolar type 13.93 11.32 5 55443 130 64443154
Constipation 13.91 11.32 128 55320 229209 64214075
Drug ineffective 13.80 11.32 867 54581 839380 63603904
Drug eruption 13.64 11.32 7 55441 36129 64407155
Injection site erythema 13.63 11.32 25 55423 70775 64372509
Physical assault 13.58 11.32 11 55437 1535 64441749
Shock 13.57 11.32 8 55440 38232 64405052
Dysphemia 13.51 11.32 15 55433 3104 64440180
Palmar-plantar erythrodysaesthesia syndrome 13.49 11.32 4 55444 28815 64414469
Dyspnoea exertional 13.36 11.32 27 55421 73703 64369581
Urinary incontinence 13.32 11.32 64 55384 36087 64407197
Arthritis 13.30 11.32 33 55415 83781 64359503
Haematochezia 13.17 11.32 23 55425 66350 64376934
Poor sucking reflex 13.14 11.32 4 55444 61 64443223
Chills 13.10 11.32 67 55381 137197 64306087
Liver disorder 13.02 11.32 16 55432 53335 64389949
Hypomagnesaemia 13.01 11.32 8 55440 37368 64405916
Hepatitis 12.99 11.32 12 55436 45570 64397714
Pressure of speech 12.99 11.32 9 55439 992 64442292
Electroencephalogram abnormal 12.96 11.32 19 55429 5184 64438100
Sedation 12.90 11.32 70 55378 41392 64401892
Impaired healing 12.89 11.32 20 55428 60453 64382831
Myocarditis 12.87 11.32 38 55410 17005 64426279
Personality change 12.87 11.32 25 55423 8568 64434716
Water intoxication 12.79 11.32 8 55440 742 64442542
Drug abuser 12.75 11.32 20 55428 5788 64437496
Libido decreased 12.69 11.32 18 55430 4766 64438518
Neoplasm progression 12.63 11.32 10 55438 40954 64402330
Gastric bypass 12.60 11.32 9 55439 1041 64442243
COVID-19 12.54 11.32 23 55425 65117 64378167
Hepatitis C virus test positive 12.51 11.32 6 55442 329 64442955
Product dose omission issue 12.49 11.32 236 55212 194511 64248773
Full blood count abnormal 12.42 11.32 5 55443 29752 64413532
Pneumonitis 12.40 11.32 15 55433 50350 64392934
Learning disorder 12.39 11.32 7 55441 539 64442745
Psychotic symptom 12.35 11.32 12 55436 2126 64441158
Gastrointestinal disorder 12.24 11.32 38 55410 89671 64353613
Haematoma 12.23 11.32 13 55435 46237 64397047
Gastrooesophageal reflux disease 12.23 11.32 34 55414 83109 64360175
Sydenham's chorea 12.22 11.32 3 55445 19 64443265
Asphyxia 12.16 11.32 26 55422 9540 64433744
Defect conduction intraventricular 12.10 11.32 6 55442 354 64442930
Autophobia 12.09 11.32 3 55445 20 64443264
Bezoar 12.05 11.32 12 55436 2191 64441093
Henoch-Schonlein purpura 12.04 11.32 12 55436 2194 64441090
Electrocardiogram ST segment elevation 11.96 11.32 22 55426 7237 64436047
Osteonecrosis of jaw 11.94 11.32 10 55438 39815 64403469
Thrombosis 11.85 11.32 27 55421 70615 64372669
Application site scab 11.81 11.32 5 55443 204 64443080
Arrhythmia 11.80 11.32 82 55366 52862 64390422
Hypomania 11.77 11.32 19 55429 5635 64437649
Hypersensitivity 11.76 11.32 110 55338 196342 64246942
Renal disorder 11.73 11.32 8 55440 35357 64407927
Muscle tightness 11.66 11.32 28 55420 11087 64432197
Myocardial infarction 11.65 11.32 89 55359 165732 64277552
Injection site swelling 11.65 11.32 11 55437 41342 64401942
Rash maculo-papular 11.59 11.32 14 55434 47012 64396272
Persecutory delusion 11.56 11.32 16 55432 4142 64439142
Verbigeration 11.50 11.32 3 55445 25 64443259
Streptococcal infection 11.50 11.32 22 55426 7457 64435827

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC N06BA04 NERVOUS SYSTEM
PSYCHOANALEPTICS
PSYCHOSTIMULANTS, AGENTS USED FOR ADHD AND NOOTROPICS
Centrally acting sympathomimetics
MeSH PA D002491 Central Nervous System Agents
MeSH PA D000697 Central Nervous System Stimulants
MeSH PA D015259 Dopamine Agents
MeSH PA D018765 Dopamine Uptake Inhibitors
MeSH PA D049990 Membrane Transport Modulators
MeSH PA D018377 Neurotransmitter Agents
MeSH PA D014179 Neurotransmitter Uptake Inhibitors
CHEBI has role CHEBI:35337 analeptic
CHEBI has role CHEBI:35471 psychotropic drugs
CHEBI has role CHEBI:35524 sympathomimetic
CHEBI has role CHEBI:35640 adrenergic uptake inhibitors
CHEBI has role CHEBI:37962 adrenergic agents
CHEBI has role CHEBI:51039 dopamine reuptake inhibitor
FDA PE N0000175729 Central Nervous System Stimulation
FDA EPC N0000175739 Central Nervous System Stimulant

Drug Use | Suggest Off label Use Form| |View source of the data|

DiseaseRelationSNOMED_IDDOID
Narcolepsy indication 60380001 DOID:8986
Attention deficit hyperactivity disorder indication 406506008
Depressive disorder off-label use 35489007
Cognitive Impairment following Traumatic Brain Injury off-label use
Gilles de la Tourette's syndrome contraindication 5158005 DOID:11119
Dependent drug abuse contraindication 6525002
Alcoholism contraindication 7200002
Sinus tachycardia contraindication 11092001
Bipolar disorder contraindication 13746004 DOID:3312
Mood swings contraindication 18963009
Lowered convulsive threshold contraindication 19260006
Myocardial infarction contraindication 22298006 DOID:5844
Glaucoma contraindication 23986001 DOID:1686
Feeling agitated contraindication 24199005
Short bowel syndrome contraindication 26629001 DOID:10605
Hyperthyroidism contraindication 34486009 DOID:7998
Hypertensive disorder contraindication 38341003 DOID:10763
Conduction disorder of the heart contraindication 44808001
Chronic heart failure contraindication 48447003
Tension contraindication 53489000
Anorexia nervosa contraindication 56882008 DOID:8689
Aggressive behavior contraindication 61372001
Substance abuse contraindication 66214007
Psychotic disorder contraindication 69322001
Severe anxiety (panic) contraindication 80583007
Epilepsy contraindication 84757009 DOID:1826
Leukopenia contraindication 84828003 DOID:615
Cardiomyopathy contraindication 85898001 DOID:0050700
Thyrotoxicosis contraindication 90739004 DOID:7997
Blurring of visual image contraindication 111516008
Gastrointestinal obstruction contraindication 126765001
Structural disorder of heart contraindication 128599005
Seizure disorder contraindication 128613002
Liver function tests abnormal contraindication 166603001
Angina pectoris contraindication 194828000
Motor tic disorder contraindication 230337001
Cerebrovascular accident contraindication 230690007
Mania contraindication 231494001
Esophageal dysmotility contraindication 266434009 DOID:9192
Anemia contraindication 271737000 DOID:2355
Thrombocytopenic disorder contraindication 302215000 DOID:1588
Visual impairment contraindication 397540003
Disorder of coronary artery contraindication 414024009
Myocardial infarction in recovery phase contraindication 418044006
Hypertensive urgency contraindication 443482000
Life-Threatening Cardiac Arrhythmias contraindication
Uncontrolled Epilepsy contraindication




๐Ÿถ Veterinary Drug Use

None

๐Ÿถ Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 8.68 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
10MG/9HR (1.1MG/HR) DAYTRANA NOVEN PHARMS INC N021514 April 6, 2006 RX FILM, EXTENDED RELEASE TRANSDERMAL 9668981 Oct. 7, 2025 METHOD FOR TRANSDERMALLY DELIVERING A DRUG TO A USER IN NEED THEREOF
15MG/9HR (1.6MG/HR) DAYTRANA NOVEN PHARMS INC N021514 April 6, 2006 RX FILM, EXTENDED RELEASE TRANSDERMAL 9668981 Oct. 7, 2025 METHOD FOR TRANSDERMALLY DELIVERING A DRUG TO A USER IN NEED THEREOF
20MG/9HR (2.2MG/HR) DAYTRANA NOVEN PHARMS INC N021514 April 6, 2006 RX FILM, EXTENDED RELEASE TRANSDERMAL 9668981 Oct. 7, 2025 METHOD FOR TRANSDERMALLY DELIVERING A DRUG TO A USER IN NEED THEREOF
30MG/9HR (3.3MG/HR) DAYTRANA NOVEN PHARMS INC N021514 April 6, 2006 RX FILM, EXTENDED RELEASE TRANSDERMAL 9668981 Oct. 7, 2025 METHOD FOR TRANSDERMALLY DELIVERING A DRUG TO A USER IN NEED THEREOF
5MG/ML QUILLIVANT XR NEXTWAVE N202100 Sept. 27, 2012 RX FOR SUSPENSION, EXTENDED RELEASE ORAL 8465765 Feb. 15, 2031 TREATING A PATIENT HAVING A CONDITION SUSCEPTIBLE TO TREATMENT WITH METHYLPHENIDATE, SUCH AS ADHD, BY ADMINISTERING THE FORMULATION RECITED IN CLAIMS 1 OR 2
5MG/ML QUILLIVANT XR NEXTWAVE N202100 Sept. 27, 2012 RX FOR SUSPENSION, EXTENDED RELEASE ORAL 8563033 Feb. 15, 2031 TREATING A PATIENT HAVING A CONDITION SUSCEPTIBLE TO TREATMENT WITH METHYLPHENIDATE, SUCH AS ADHD, BY ADMINISTERING THE FORMULATION RECITED IN CLAIMS 1 OR 2
5MG/ML QUILLIVANT XR NEXTWAVE N202100 Sept. 27, 2012 RX FOR SUSPENSION, EXTENDED RELEASE ORAL 8778390 Feb. 15, 2031 TREATMENT OF A PATIENT BY ADMINISTERING THE FORMULATION RECITED IN CLAIM 1 OR CLAIM 23
5MG/ML QUILLIVANT XR NEXTWAVE N202100 Sept. 27, 2012 RX FOR SUSPENSION, EXTENDED RELEASE ORAL 8956649 Feb. 15, 2031 METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER BY ADMINISTERING THE COMPOSITION OF CLAIM 1
100MG JORNAY PM IRONSHORE PHARMS N209311 Aug. 8, 2018 RX CAPSULE, EXTENDED RELEASE ORAL 10292937 March 23, 2032 METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
100MG JORNAY PM IRONSHORE PHARMS N209311 Aug. 8, 2018 RX CAPSULE, EXTENDED RELEASE ORAL 10617651 March 23, 2032 METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
100MG JORNAY PM IRONSHORE PHARMS N209311 Aug. 8, 2018 RX CAPSULE, EXTENDED RELEASE ORAL 10881618 March 23, 2032 METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
100MG JORNAY PM IRONSHORE PHARMS N209311 Aug. 8, 2018 RX CAPSULE, EXTENDED RELEASE ORAL 11241391 March 23, 2032 METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
100MG JORNAY PM IRONSHORE PHARMS N209311 Aug. 8, 2018 RX CAPSULE, EXTENDED RELEASE ORAL 8916588 March 23, 2032 METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
100MG JORNAY PM IRONSHORE PHARMS N209311 Aug. 8, 2018 RX CAPSULE, EXTENDED RELEASE ORAL 9028868 March 23, 2032 METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
100MG JORNAY PM IRONSHORE PHARMS N209311 Aug. 8, 2018 RX CAPSULE, EXTENDED RELEASE ORAL 9034902 March 23, 2032 METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
100MG JORNAY PM IRONSHORE PHARMS N209311 Aug. 8, 2018 RX CAPSULE, EXTENDED RELEASE ORAL 9603809 March 23, 2032 METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
20MG JORNAY PM IRONSHORE PHARMS N209311 Aug. 8, 2018 RX CAPSULE, EXTENDED RELEASE ORAL 10292937 March 23, 2032 METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
20MG JORNAY PM IRONSHORE PHARMS N209311 Aug. 8, 2018 RX CAPSULE, EXTENDED RELEASE ORAL 10617651 March 23, 2032 METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
20MG JORNAY PM IRONSHORE PHARMS N209311 Aug. 8, 2018 RX CAPSULE, EXTENDED RELEASE ORAL 10881618 March 23, 2032 METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
20MG JORNAY PM IRONSHORE PHARMS N209311 Aug. 8, 2018 RX CAPSULE, EXTENDED RELEASE ORAL 11241391 March 23, 2032 METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
20MG JORNAY PM IRONSHORE PHARMS N209311 Aug. 8, 2018 RX CAPSULE, EXTENDED RELEASE ORAL 8916588 March 23, 2032 METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
20MG JORNAY PM IRONSHORE PHARMS N209311 Aug. 8, 2018 RX CAPSULE, EXTENDED RELEASE ORAL 9028868 March 23, 2032 METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
20MG JORNAY PM IRONSHORE PHARMS N209311 Aug. 8, 2018 RX CAPSULE, EXTENDED RELEASE ORAL 9034902 March 23, 2032 METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
20MG JORNAY PM IRONSHORE PHARMS N209311 Aug. 8, 2018 RX CAPSULE, EXTENDED RELEASE ORAL 9603809 March 23, 2032 METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
40MG JORNAY PM IRONSHORE PHARMS N209311 Aug. 8, 2018 RX CAPSULE, EXTENDED RELEASE ORAL 10292937 March 23, 2032 METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
40MG JORNAY PM IRONSHORE PHARMS N209311 Aug. 8, 2018 RX CAPSULE, EXTENDED RELEASE ORAL 10617651 March 23, 2032 METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
40MG JORNAY PM IRONSHORE PHARMS N209311 Aug. 8, 2018 RX CAPSULE, EXTENDED RELEASE ORAL 10881618 March 23, 2032 METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
40MG JORNAY PM IRONSHORE PHARMS N209311 Aug. 8, 2018 RX CAPSULE, EXTENDED RELEASE ORAL 11241391 March 23, 2032 METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
40MG JORNAY PM IRONSHORE PHARMS N209311 Aug. 8, 2018 RX CAPSULE, EXTENDED RELEASE ORAL 8916588 March 23, 2032 METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
40MG JORNAY PM IRONSHORE PHARMS N209311 Aug. 8, 2018 RX CAPSULE, EXTENDED RELEASE ORAL 9028868 March 23, 2032 METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
40MG JORNAY PM IRONSHORE PHARMS N209311 Aug. 8, 2018 RX CAPSULE, EXTENDED RELEASE ORAL 9034902 March 23, 2032 METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
40MG JORNAY PM IRONSHORE PHARMS N209311 Aug. 8, 2018 RX CAPSULE, EXTENDED RELEASE ORAL 9603809 March 23, 2032 METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
60MG JORNAY PM IRONSHORE PHARMS N209311 Aug. 8, 2018 RX CAPSULE, EXTENDED RELEASE ORAL 10292937 March 23, 2032 METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
60MG JORNAY PM IRONSHORE PHARMS N209311 Aug. 8, 2018 RX CAPSULE, EXTENDED RELEASE ORAL 10617651 March 23, 2032 METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
60MG JORNAY PM IRONSHORE PHARMS N209311 Aug. 8, 2018 RX CAPSULE, EXTENDED RELEASE ORAL 10881618 March 23, 2032 METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
60MG JORNAY PM IRONSHORE PHARMS N209311 Aug. 8, 2018 RX CAPSULE, EXTENDED RELEASE ORAL 11241391 March 23, 2032 METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
60MG JORNAY PM IRONSHORE PHARMS N209311 Aug. 8, 2018 RX CAPSULE, EXTENDED RELEASE ORAL 8916588 March 23, 2032 METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
60MG JORNAY PM IRONSHORE PHARMS N209311 Aug. 8, 2018 RX CAPSULE, EXTENDED RELEASE ORAL 9028868 March 23, 2032 METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
60MG JORNAY PM IRONSHORE PHARMS N209311 Aug. 8, 2018 RX CAPSULE, EXTENDED RELEASE ORAL 9034902 March 23, 2032 METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
60MG JORNAY PM IRONSHORE PHARMS N209311 Aug. 8, 2018 RX CAPSULE, EXTENDED RELEASE ORAL 9603809 March 23, 2032 METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
80MG JORNAY PM IRONSHORE PHARMS N209311 Aug. 8, 2018 RX CAPSULE, EXTENDED RELEASE ORAL 10292937 March 23, 2032 METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
80MG JORNAY PM IRONSHORE PHARMS N209311 Aug. 8, 2018 RX CAPSULE, EXTENDED RELEASE ORAL 10617651 March 23, 2032 METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
80MG JORNAY PM IRONSHORE PHARMS N209311 Aug. 8, 2018 RX CAPSULE, EXTENDED RELEASE ORAL 10881618 March 23, 2032 METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
80MG JORNAY PM IRONSHORE PHARMS N209311 Aug. 8, 2018 RX CAPSULE, EXTENDED RELEASE ORAL 11241391 March 23, 2032 METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
80MG JORNAY PM IRONSHORE PHARMS N209311 Aug. 8, 2018 RX CAPSULE, EXTENDED RELEASE ORAL 8916588 March 23, 2032 METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
80MG JORNAY PM IRONSHORE PHARMS N209311 Aug. 8, 2018 RX CAPSULE, EXTENDED RELEASE ORAL 9028868 March 23, 2032 METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
80MG JORNAY PM IRONSHORE PHARMS N209311 Aug. 8, 2018 RX CAPSULE, EXTENDED RELEASE ORAL 9034902 March 23, 2032 METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
80MG JORNAY PM IRONSHORE PHARMS N209311 Aug. 8, 2018 RX CAPSULE, EXTENDED RELEASE ORAL 9603809 March 23, 2032 METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
20MG QUILLICHEW ER NEXTWAVE PHARMS N207960 Dec. 4, 2015 RX TABLET, EXTENDED RELEASE, CHEWABLE ORAL 10857143 Aug. 14, 2033 A METHOD FOR TREATING A SUBJECT HAVING ADHD, SAID METHOD COMPRISING ORALLY ADMINISTERING TO SAID SUBJECT A RACEMIC METHYLPHENIDATE CHEWABLE TABLET AS CLAIMED
20MG QUILLICHEW ER NEXTWAVE PHARMS N207960 Dec. 4, 2015 RX TABLET, EXTENDED RELEASE, CHEWABLE ORAL 11103495 Aug. 14, 2033 A METHOD FOR TREATING A SUBJECT HAVING ADHD, SAID METHOD COMPRISING ORALLY ADMINISTERING TO SAID SUBJECT A RACEMIC METHYLPHENIDATE CHEWABLE TABLET AS CLAIMED
20MG QUILLICHEW ER NEXTWAVE PHARMS N207960 Dec. 4, 2015 RX TABLET, EXTENDED RELEASE, CHEWABLE ORAL 9295642 Aug. 14, 2033 A METHOD OF PROVIDING A SUBJECT WITH THERAPEUTICALLY EFFECTIVE AMOUNT OF RACEMIC METHYLPHENIDATE BY ORALLY ADMINISTERING TO SAID SUBJECT A SINGLE METHYLPHENIDATE EXTENDED RELEASE CHEWABLE TABLET ACCORDING TO CLAIM 1
20MG QUILLICHEW ER NEXTWAVE PHARMS N207960 Dec. 4, 2015 RX TABLET, EXTENDED RELEASE, CHEWABLE ORAL 9545399 Aug. 14, 2033 A METHOD OF PROVIDING A SUBJECT WITH THERAPEUTICALLY EFFECTIVE AMOUNT OF RACEMIC METHYLPHENIDATE BY ORALLY ADMINISTERING TO SAID SUBJECT A SINGLE METHYLPHENIDATE EXTENDED RELEASE CHEWABLE TABLET ACCORDING TO CLAIM 1
20MG QUILLICHEW ER NEXTWAVE PHARMS N207960 Dec. 4, 2015 RX TABLET, EXTENDED RELEASE, CHEWABLE ORAL 9844544 Aug. 14, 2033 A METHOD OF PROVIDING A SUBJECT WITH A THERAPEUTICALLY EFFECTIVE AMOUNT OF RACEMIC METHYLPHENIDATE BY ORALLY ADMINISTERING TO SAID SUBJECT A SINGLE METHYLPHENIDATE EXTENDED RELEASE CHEWABLE TABLET AS CLAIMED
30MG QUILLICHEW ER NEXTWAVE PHARMS N207960 Dec. 4, 2015 RX TABLET, EXTENDED RELEASE, CHEWABLE ORAL 10857143 Aug. 14, 2033 A METHOD FOR TREATING A SUBJECT HAVING ADHD, SAID METHOD COMPRISING ORALLY ADMINISTERING TO SAID SUBJECT A RACEMIC METHYLPHENIDATE CHEWABLE TABLET AS CLAIMED
30MG QUILLICHEW ER NEXTWAVE PHARMS N207960 Dec. 4, 2015 RX TABLET, EXTENDED RELEASE, CHEWABLE ORAL 11103495 Aug. 14, 2033 A METHOD FOR TREATING A SUBJECT HAVING ADHD, SAID METHOD COMPRISING ORALLY ADMINISTERING TO SAID SUBJECT A RACEMIC METHYLPHENIDATE CHEWABLE TABLET AS CLAIMED
30MG QUILLICHEW ER NEXTWAVE PHARMS N207960 Dec. 4, 2015 RX TABLET, EXTENDED RELEASE, CHEWABLE ORAL 9295642 Aug. 14, 2033 A METHOD OF PROVIDING A SUBJECT WITH THERAPEUTICALLY EFFECTIVE AMOUNT OF RACEMIC METHYLPHENIDATE BY ORALLY ADMINISTERING TO SAID SUBJECT A SINGLE METHYLPHENIDATE EXTENDED RELEASE CHEWABLE TABLET ACCORDING TO CLAIM 1
30MG QUILLICHEW ER NEXTWAVE PHARMS N207960 Dec. 4, 2015 RX TABLET, EXTENDED RELEASE, CHEWABLE ORAL 9545399 Aug. 14, 2033 A METHOD OF PROVIDING A SUBJECT WITH THERAPEUTICALLY EFFECTIVE AMOUNT OF RACEMIC METHYLPHENIDATE BY ORALLY ADMINISTERING TO SAID SUBJECT A SINGLE METHYLPHENIDATE EXTENDED RELEASE CHEWABLE TABLET ACCORDING TO CLAIM 1
30MG QUILLICHEW ER NEXTWAVE PHARMS N207960 Dec. 4, 2015 RX TABLET, EXTENDED RELEASE, CHEWABLE ORAL 9844544 Aug. 14, 2033 A METHOD OF PROVIDING A SUBJECT WITH A THERAPEUTICALLY EFFECTIVE AMOUNT OF RACEMIC METHYLPHENIDATE BY ORALLY ADMINISTERING TO SAID SUBJECT A SINGLE METHYLPHENIDATE EXTENDED RELEASE CHEWABLE TABLET AS CLAIMED
40MG QUILLICHEW ER NEXTWAVE PHARMS N207960 Dec. 4, 2015 RX TABLET, EXTENDED RELEASE, CHEWABLE ORAL 10857143 Aug. 14, 2033 A METHOD FOR TREATING A SUBJECT HAVING ADHD, SAID METHOD COMPRISING ORALLY ADMINISTERING TO SAID SUBJECT A RACEMIC METHYLPHENIDATE CHEWABLE TABLET AS CLAIMED
40MG QUILLICHEW ER NEXTWAVE PHARMS N207960 Dec. 4, 2015 RX TABLET, EXTENDED RELEASE, CHEWABLE ORAL 11103495 Aug. 14, 2033 A METHOD FOR TREATING A SUBJECT HAVING ADHD, SAID METHOD COMPRISING ORALLY ADMINISTERING TO SAID SUBJECT A RACEMIC METHYLPHENIDATE CHEWABLE TABLET AS CLAIMED
40MG QUILLICHEW ER NEXTWAVE PHARMS N207960 Dec. 4, 2015 RX TABLET, EXTENDED RELEASE, CHEWABLE ORAL 9295642 Aug. 14, 2033 A METHOD OF PROVIDING A SUBJECT WITH THERAPEUTICALLY EFFECTIVE AMOUNT OF RACEMIC METHYLPHENIDATE BY ORALLY ADMINISTERING TO SAID SUBJECT A SINGLE METHYLPHENIDATE EXTENDED RELEASE CHEWABLE TABLET ACCORDING TO CLAIM 1
40MG QUILLICHEW ER NEXTWAVE PHARMS N207960 Dec. 4, 2015 RX TABLET, EXTENDED RELEASE, CHEWABLE ORAL 9545399 Aug. 14, 2033 A METHOD OF PROVIDING A SUBJECT WITH THERAPEUTICALLY EFFECTIVE AMOUNT OF RACEMIC METHYLPHENIDATE BY ORALLY ADMINISTERING TO SAID SUBJECT A SINGLE METHYLPHENIDATE EXTENDED RELEASE CHEWABLE TABLET ACCORDING TO CLAIM 1
40MG QUILLICHEW ER NEXTWAVE PHARMS N207960 Dec. 4, 2015 RX TABLET, EXTENDED RELEASE, CHEWABLE ORAL 9844544 Aug. 14, 2033 A METHOD OF PROVIDING A SUBJECT WITH A THERAPEUTICALLY EFFECTIVE AMOUNT OF RACEMIC METHYLPHENIDATE BY ORALLY ADMINISTERING TO SAID SUBJECT A SINGLE METHYLPHENIDATE EXTENDED RELEASE CHEWABLE TABLET AS CLAIMED
25MG ADHANSIA XR PURDUE PHARMA LP N212038 Feb. 27, 2019 RX CAPSULE, EXTENDED RELEASE ORAL 10111839 Oct. 30, 2035 METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
25MG ADHANSIA XR PURDUE PHARMA LP N212038 Feb. 27, 2019 RX CAPSULE, EXTENDED RELEASE ORAL 10292939 Oct. 30, 2035 METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
25MG ADHANSIA XR PURDUE PHARMA LP N212038 Feb. 27, 2019 RX CAPSULE, EXTENDED RELEASE ORAL 10449159 Oct. 30, 2035 METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
25MG ADHANSIA XR PURDUE PHARMA LP N212038 Feb. 27, 2019 RX CAPSULE, EXTENDED RELEASE ORAL 10500162 Oct. 30, 2035 METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
25MG ADHANSIA XR PURDUE PHARMA LP N212038 Feb. 27, 2019 RX CAPSULE, EXTENDED RELEASE ORAL 10512613 Oct. 30, 2035 METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
25MG ADHANSIA XR PURDUE PHARMA LP N212038 Feb. 27, 2019 RX CAPSULE, EXTENDED RELEASE ORAL 10568841 Oct. 30, 2035 METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
35MG ADHANSIA XR PURDUE PHARMA LP N212038 Feb. 27, 2019 RX CAPSULE, EXTENDED RELEASE ORAL 10111839 Oct. 30, 2035 METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
35MG ADHANSIA XR PURDUE PHARMA LP N212038 Feb. 27, 2019 RX CAPSULE, EXTENDED RELEASE ORAL 10292939 Oct. 30, 2035 METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
35MG ADHANSIA XR PURDUE PHARMA LP N212038 Feb. 27, 2019 RX CAPSULE, EXTENDED RELEASE ORAL 10449159 Oct. 30, 2035 METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
35MG ADHANSIA XR PURDUE PHARMA LP N212038 Feb. 27, 2019 RX CAPSULE, EXTENDED RELEASE ORAL 10500162 Oct. 30, 2035 METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
35MG ADHANSIA XR PURDUE PHARMA LP N212038 Feb. 27, 2019 RX CAPSULE, EXTENDED RELEASE ORAL 10512613 Oct. 30, 2035 METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
35MG ADHANSIA XR PURDUE PHARMA LP N212038 Feb. 27, 2019 RX CAPSULE, EXTENDED RELEASE ORAL 10568841 Oct. 30, 2035 METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
45MG ADHANSIA XR PURDUE PHARMA LP N212038 Feb. 27, 2019 RX CAPSULE, EXTENDED RELEASE ORAL 10111839 Oct. 30, 2035 METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
45MG ADHANSIA XR PURDUE PHARMA LP N212038 Feb. 27, 2019 RX CAPSULE, EXTENDED RELEASE ORAL 10292939 Oct. 30, 2035 METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
45MG ADHANSIA XR PURDUE PHARMA LP N212038 Feb. 27, 2019 RX CAPSULE, EXTENDED RELEASE ORAL 10449159 Oct. 30, 2035 METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
45MG ADHANSIA XR PURDUE PHARMA LP N212038 Feb. 27, 2019 RX CAPSULE, EXTENDED RELEASE ORAL 10500162 Oct. 30, 2035 METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
45MG ADHANSIA XR PURDUE PHARMA LP N212038 Feb. 27, 2019 RX CAPSULE, EXTENDED RELEASE ORAL 10512613 Oct. 30, 2035 METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
45MG ADHANSIA XR PURDUE PHARMA LP N212038 Feb. 27, 2019 RX CAPSULE, EXTENDED RELEASE ORAL 10568841 Oct. 30, 2035 METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
55MG ADHANSIA XR PURDUE PHARMA LP N212038 Feb. 27, 2019 RX CAPSULE, EXTENDED RELEASE ORAL 10111839 Oct. 30, 2035 METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
55MG ADHANSIA XR PURDUE PHARMA LP N212038 Feb. 27, 2019 RX CAPSULE, EXTENDED RELEASE ORAL 10292939 Oct. 30, 2035 METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
55MG ADHANSIA XR PURDUE PHARMA LP N212038 Feb. 27, 2019 RX CAPSULE, EXTENDED RELEASE ORAL 10449159 Oct. 30, 2035 METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
55MG ADHANSIA XR PURDUE PHARMA LP N212038 Feb. 27, 2019 RX CAPSULE, EXTENDED RELEASE ORAL 10500162 Oct. 30, 2035 METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
55MG ADHANSIA XR PURDUE PHARMA LP N212038 Feb. 27, 2019 RX CAPSULE, EXTENDED RELEASE ORAL 10512613 Oct. 30, 2035 METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
55MG ADHANSIA XR PURDUE PHARMA LP N212038 Feb. 27, 2019 RX CAPSULE, EXTENDED RELEASE ORAL 10568841 Oct. 30, 2035 METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
70MG ADHANSIA XR PURDUE PHARMA LP N212038 Feb. 27, 2019 RX CAPSULE, EXTENDED RELEASE ORAL 10111839 Oct. 30, 2035 METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
70MG ADHANSIA XR PURDUE PHARMA LP N212038 Feb. 27, 2019 RX CAPSULE, EXTENDED RELEASE ORAL 10292939 Oct. 30, 2035 METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
70MG ADHANSIA XR PURDUE PHARMA LP N212038 Feb. 27, 2019 RX CAPSULE, EXTENDED RELEASE ORAL 10449159 Oct. 30, 2035 METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
70MG ADHANSIA XR PURDUE PHARMA LP N212038 Feb. 27, 2019 RX CAPSULE, EXTENDED RELEASE ORAL 10500162 Oct. 30, 2035 METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
70MG ADHANSIA XR PURDUE PHARMA LP N212038 Feb. 27, 2019 RX CAPSULE, EXTENDED RELEASE ORAL 10512613 Oct. 30, 2035 METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
70MG ADHANSIA XR PURDUE PHARMA LP N212038 Feb. 27, 2019 RX CAPSULE, EXTENDED RELEASE ORAL 10568841 Oct. 30, 2035 METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
85MG ADHANSIA XR PURDUE PHARMA LP N212038 Feb. 27, 2019 RX CAPSULE, EXTENDED RELEASE ORAL 10111839 Oct. 30, 2035 METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
85MG ADHANSIA XR PURDUE PHARMA LP N212038 Feb. 27, 2019 RX CAPSULE, EXTENDED RELEASE ORAL 10292939 Oct. 30, 2035 METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
85MG ADHANSIA XR PURDUE PHARMA LP N212038 Feb. 27, 2019 RX CAPSULE, EXTENDED RELEASE ORAL 10449159 Oct. 30, 2035 METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
85MG ADHANSIA XR PURDUE PHARMA LP N212038 Feb. 27, 2019 RX CAPSULE, EXTENDED RELEASE ORAL 10500162 Oct. 30, 2035 METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
85MG ADHANSIA XR PURDUE PHARMA LP N212038 Feb. 27, 2019 RX CAPSULE, EXTENDED RELEASE ORAL 10512613 Oct. 30, 2035 METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
85MG ADHANSIA XR PURDUE PHARMA LP N212038 Feb. 27, 2019 RX CAPSULE, EXTENDED RELEASE ORAL 10568841 Oct. 30, 2035 METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
17.3MG COTEMPLA XR-ODT NEOS THERAPS INC N205489 June 19, 2017 RX TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE ORAL 11166947 Jan. 25, 2038 TREATMENT OF ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD) IN PEDIATRIC PATIENTS
25.9MG COTEMPLA XR-ODT NEOS THERAPS INC N205489 June 19, 2017 RX TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE ORAL 11166947 Jan. 25, 2038 TREATMENT OF ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD) IN PEDIATRIC PATIENTS
8.6MG COTEMPLA XR-ODT NEOS THERAPS INC N205489 June 19, 2017 RX TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE ORAL 11166947 Jan. 25, 2038 TREATMENT OF ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD) IN PEDIATRIC PATIENTS
25MG ADHANSIA XR PURDUE PHARMA LP N212038 Feb. 27, 2019 RX CAPSULE, EXTENDED RELEASE ORAL 10722473 Nov. 19, 2038 METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
35MG ADHANSIA XR PURDUE PHARMA LP N212038 Feb. 27, 2019 RX CAPSULE, EXTENDED RELEASE ORAL 10722473 Nov. 19, 2038 METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
45MG ADHANSIA XR PURDUE PHARMA LP N212038 Feb. 27, 2019 RX CAPSULE, EXTENDED RELEASE ORAL 10722473 Nov. 19, 2038 METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
55MG ADHANSIA XR PURDUE PHARMA LP N212038 Feb. 27, 2019 RX CAPSULE, EXTENDED RELEASE ORAL 10722473 Nov. 19, 2038 METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
70MG ADHANSIA XR PURDUE PHARMA LP N212038 Feb. 27, 2019 RX CAPSULE, EXTENDED RELEASE ORAL 10722473 Nov. 19, 2038 METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
85MG ADHANSIA XR PURDUE PHARMA LP N212038 Feb. 27, 2019 RX CAPSULE, EXTENDED RELEASE ORAL 10722473 Nov. 19, 2038 METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
25MG ADHANSIA XR PURDUE PHARMA LP N212038 Feb. 27, 2019 RX CAPSULE, EXTENDED RELEASE ORAL Feb. 27, 2022 NEW PRODUCT
35MG ADHANSIA XR PURDUE PHARMA LP N212038 Feb. 27, 2019 RX CAPSULE, EXTENDED RELEASE ORAL Feb. 27, 2022 NEW PRODUCT
45MG ADHANSIA XR PURDUE PHARMA LP N212038 Feb. 27, 2019 RX CAPSULE, EXTENDED RELEASE ORAL Feb. 27, 2022 NEW PRODUCT
55MG ADHANSIA XR PURDUE PHARMA LP N212038 Feb. 27, 2019 RX CAPSULE, EXTENDED RELEASE ORAL Feb. 27, 2022 NEW PRODUCT
70MG ADHANSIA XR PURDUE PHARMA LP N212038 Feb. 27, 2019 RX CAPSULE, EXTENDED RELEASE ORAL Feb. 27, 2022 NEW PRODUCT
85MG ADHANSIA XR PURDUE PHARMA LP N212038 Feb. 27, 2019 RX CAPSULE, EXTENDED RELEASE ORAL Feb. 27, 2022 NEW PRODUCT
25MG ADHANSIA XR PURDUE PHARMA LP N212038 Feb. 27, 2019 RX CAPSULE, EXTENDED RELEASE ORAL June 28, 2024 LABELING REVISIONS RELATED TO CLINICAL STUDIES
35MG ADHANSIA XR PURDUE PHARMA LP N212038 Feb. 27, 2019 RX CAPSULE, EXTENDED RELEASE ORAL June 28, 2024 LABELING REVISIONS RELATED TO CLINICAL STUDIES
45MG ADHANSIA XR PURDUE PHARMA LP N212038 Feb. 27, 2019 RX CAPSULE, EXTENDED RELEASE ORAL June 28, 2024 LABELING REVISIONS RELATED TO CLINICAL STUDIES
55MG ADHANSIA XR PURDUE PHARMA LP N212038 Feb. 27, 2019 RX CAPSULE, EXTENDED RELEASE ORAL June 28, 2024 LABELING REVISIONS RELATED TO CLINICAL STUDIES
70MG ADHANSIA XR PURDUE PHARMA LP N212038 Feb. 27, 2019 RX CAPSULE, EXTENDED RELEASE ORAL June 28, 2024 LABELING REVISIONS RELATED TO CLINICAL STUDIES
85MG ADHANSIA XR PURDUE PHARMA LP N212038 Feb. 27, 2019 RX CAPSULE, EXTENDED RELEASE ORAL June 28, 2024 LABELING REVISIONS RELATED TO CLINICAL STUDIES

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Sodium-dependent dopamine transporter Transporter INHIBITOR Ki 6.96 CHEMBL CHEMBL
Sodium-dependent noradrenaline transporter Transporter INHIBITOR Ki 6.18 CHEMBL CHEMBL
Alpha-2A adrenergic receptor GPCR Ki 5.25 PDSP
Alpha-2C adrenergic receptor GPCR Ki 6.07 PDSP
Alpha-2B adrenergic receptor GPCR Ki 5.62 PDSP
Sodium-dependent serotonin transporter Transporter Ki 4.19 CHEMBL
Sodium-dependent dopamine transporter Transporter IC50 7.08 CHEMBL

External reference:

IDSource
4019832 VUID
N0000147920 NUI
D01296 KEGG_DRUG
23655-65-4 SECONDARY_CAS_RN
4018198 VANDF
4019832 VANDF
C0025810 UMLSCUI
CHEBI:6887 CHEBI
CHEMBL796 ChEMBL_ID
DB00422 DRUGBANK_ID
CHEMBL1722 ChEMBL_ID
D008774 MESH_DESCRIPTOR_UI
4158 PUBCHEM_CID
485 INN_ID
7236 IUPHAR_LIGAND_ID
207ZZ9QZ49 UNII
203188 RXNORM
1038 MMSL
32827 MMSL
37867 MMSL
5092 MMSL
d00900 MMSL
001540 NDDF
004619 NDDF
18548003 SNOMEDCT_US
373337007 SNOMEDCT_US
42163009 SNOMEDCT_US
20748-11-2 SECONDARY_CAS_RN

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Ritalin LA HUMAN PRESCRIPTION DRUG LABEL 1 0078-0370 CAPSULE, EXTENDED RELEASE 20 mg ORAL NDA 33 sections
Ritalin LA HUMAN PRESCRIPTION DRUG LABEL 1 0078-0371 CAPSULE, EXTENDED RELEASE 30 mg ORAL NDA 33 sections
Ritalin LA HUMAN PRESCRIPTION DRUG LABEL 1 0078-0372 CAPSULE, EXTENDED RELEASE 40 mg ORAL NDA 33 sections
Ritalin LA HUMAN PRESCRIPTION DRUG LABEL 1 0078-0424 CAPSULE, EXTENDED RELEASE 10 mg ORAL NDA 33 sections
Ritalin HUMAN PRESCRIPTION DRUG LABEL 1 0078-0439 TABLET 5 mg ORAL NDA 30 sections
Ritalin HUMAN PRESCRIPTION DRUG LABEL 1 0078-0440 TABLET 10 mg ORAL NDA 30 sections
Ritalin HUMAN PRESCRIPTION DRUG LABEL 1 0078-0441 TABLET 20 mg ORAL NDA 30 sections
Methylphenidate Hydrochloride(CD) HUMAN PRESCRIPTION DRUG LABEL 1 0093-5292 CAPSULE, EXTENDED RELEASE 50 mg ORAL ANDA 34 sections
Methylphenidate Hydrochloride(CD) HUMAN PRESCRIPTION DRUG LABEL 1 0093-5292 CAPSULE, EXTENDED RELEASE 50 mg ORAL ANDA 34 sections
Methylphenidate Hydrochloride(CD) HUMAN PRESCRIPTION DRUG LABEL 1 0093-5293 CAPSULE, EXTENDED RELEASE 60 mg ORAL ANDA 34 sections
Methylphenidate Hydrochloride(CD) HUMAN PRESCRIPTION DRUG LABEL 1 0093-5293 CAPSULE, EXTENDED RELEASE 60 mg ORAL ANDA 34 sections
Methylphenidate Hydrochloride(CD) HUMAN PRESCRIPTION DRUG LABEL 1 0093-5295 CAPSULE, EXTENDED RELEASE 10 mg ORAL ANDA 34 sections
Methylphenidate Hydrochloride(CD) HUMAN PRESCRIPTION DRUG LABEL 1 0093-5295 CAPSULE, EXTENDED RELEASE 10 mg ORAL ANDA 34 sections
Methylphenidate Hydrochloride(CD) HUMAN PRESCRIPTION DRUG LABEL 1 0093-5296 CAPSULE, EXTENDED RELEASE 20 mg ORAL ANDA 34 sections
Methylphenidate Hydrochloride(CD) HUMAN PRESCRIPTION DRUG LABEL 1 0093-5296 CAPSULE, EXTENDED RELEASE 20 mg ORAL ANDA 34 sections
Methylphenidate Hydrochloride(CD) HUMAN PRESCRIPTION DRUG LABEL 1 0093-5297 CAPSULE, EXTENDED RELEASE 30 mg ORAL ANDA 34 sections
Methylphenidate Hydrochloride(CD) HUMAN PRESCRIPTION DRUG LABEL 1 0093-5297 CAPSULE, EXTENDED RELEASE 30 mg ORAL ANDA 34 sections
Methylphenidate Hydrochloride(CD) HUMAN PRESCRIPTION DRUG LABEL 1 0093-5298 CAPSULE, EXTENDED RELEASE 40 mg ORAL ANDA 34 sections
Methylphenidate Hydrochloride(CD) HUMAN PRESCRIPTION DRUG LABEL 1 0093-5298 CAPSULE, EXTENDED RELEASE 40 mg ORAL ANDA 34 sections
Methylphenidate Hydrochloride(LA) HUMAN PRESCRIPTION DRUG LABEL 1 0093-5346 CAPSULE, EXTENDED RELEASE 20 mg ORAL ANDA 29 sections
Methylphenidate Hydrochloride(LA) HUMAN PRESCRIPTION DRUG LABEL 1 0093-5347 CAPSULE, EXTENDED RELEASE 30 mg ORAL ANDA 29 sections
Methylphenidate Hydrochloride(LA) HUMAN PRESCRIPTION DRUG LABEL 1 0093-5348 CAPSULE, EXTENDED RELEASE 40 mg ORAL ANDA 29 sections
Methylphenidate Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0115-1736 CAPSULE, EXTENDED RELEASE 10 mg ORAL ANDA 15 sections
Methylphenidate Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0115-1737 CAPSULE, EXTENDED RELEASE 20 mg ORAL ANDA 15 sections
Methylphenidate Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0115-1738 CAPSULE, EXTENDED RELEASE 30 mg ORAL ANDA 15 sections
Methylphenidate Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0115-1739 CAPSULE, EXTENDED RELEASE 40 mg ORAL ANDA 15 sections
Methylphenidate Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0115-1740 CAPSULE, EXTENDED RELEASE 50 mg ORAL ANDA 15 sections
Methylphenidate Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0115-1741 CAPSULE, EXTENDED RELEASE 60 mg ORAL ANDA 15 sections
METHYLPHENIDATE HYDROCHLORIDE HUMAN PRESCRIPTION DRUG LABEL 1 0115-1800 TABLET 5 mg ORAL ANDA 27 sections
METHYLPHENIDATE HYDROCHLORIDE HUMAN PRESCRIPTION DRUG LABEL 1 0115-1801 TABLET 10 mg ORAL ANDA 27 sections