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 437.33 11.34 350 42076 62071 63384525
Anxiety 279.59 11.34 512 41914 217029 63229567
Product quality issue 250.79 11.34 201 42225 35664 63410932
Product substitution issue 241.38 11.34 144 42282 15852 63430744
Depression 225.73 11.34 441 41985 196051 63250545
Agitation 213.07 11.34 230 42196 59527 63387069
Disturbance in attention 191.59 11.34 177 42249 38012 63408584
Aggression 179.99 11.34 139 42287 23359 63423237
Drug abuse 169.29 11.34 225 42201 72293 63374303
Tachycardia 168.08 11.34 291 42135 117865 63328731
No adverse event 161.11 11.34 167 42259 41238 63405358
Intentional overdose 154.85 11.34 218 42208 73934 63372662
Attention deficit hyperactivity disorder 154.72 11.34 63 42363 3013 63443583
Irritability 147.65 11.34 141 42285 31553 63415043
Abnormal behaviour 143.22 11.34 117 42309 21309 63425287
Pre-existing condition improved 142.31 11.34 81 42345 8163 63438433
Precocious puberty 133.94 11.34 31 42395 197 63446399
Intentional self-injury 132.60 11.34 121 42305 25566 63421030
Tic 130.44 11.34 46 42380 1474 63445122
Contraindicated product administered 111.62 11.34 9 42417 217639 63228957
Suicide attempt 109.63 11.34 167 42259 60751 63385845
Pulmonary malformation 105.68 11.34 27 42399 272 63446324
Glossodynia 105.64 11.34 3 42423 178873 63267723
Joint swelling 104.72 11.34 44 42382 327622 63118974
Cataplexy 103.94 11.34 37 42389 1219 63445377
Somnolence 102.73 11.34 307 42119 178378 63268218
Tremor 101.82 11.34 253 42173 131986 63314610
Toxicity to various agents 98.93 11.34 376 42050 246874 63199722
Mydriasis 94.33 11.34 72 42354 11884 63434712
Feeling abnormal 92.03 11.34 262 42164 148130 63298466
Psychotic disorder 91.64 11.34 99 42327 25613 63420983
Therapeutic response unexpected 90.30 11.34 85 42341 18674 63427922
Application site erythema 90.22 11.34 50 42376 4785 63441811
Somnambulism 89.11 11.34 52 42374 5491 63441105
Hallucination, auditory 87.74 11.34 71 42355 12753 63433843
Systemic lupus erythematosus 84.91 11.34 18 42408 208900 63237696
Wrong technique in product usage process 83.97 11.34 150 42276 62190 63384406
Withdrawal syndrome 80.19 11.34 82 42344 19915 63426681
Sleep apnoea syndrome 76.71 11.34 96 42330 29037 63417559
Intentional product misuse 75.00 11.34 141 42285 60776 63385820
Lung cyst 74.05 11.34 21 42405 323 63446273
Dystonia 73.08 11.34 66 42360 13753 63432843
Arthropathy 72.63 11.34 33 42393 234759 63211837
Overdose 72.12 11.34 204 42222 114874 63331722
Swelling 71.73 11.34 48 42378 275330 63171266
Product administered at inappropriate site 71.20 11.34 37 42389 3112 63443484
Respiratory tract malformation 71.03 11.34 18 42408 175 63446421
Paranoia 70.22 11.34 60 42366 11619 63434977
Apathy 69.47 11.34 53 42373 8741 63437855
Panic attack 69.31 11.34 80 42346 22251 63424345
Infusion related reaction 69.22 11.34 39 42387 245482 63201114
Enuresis 69.20 11.34 34 42392 2539 63444057
Pericarditis 68.67 11.34 5 42421 131574 63315022
Psychomotor hyperactivity 66.61 11.34 56 42370 10607 63435989
Diarrhoea 65.95 11.34 251 42175 715115 62731481
Application site irritation 65.29 11.34 29 42397 1721 63444875
Wound 64.44 11.34 15 42411 163248 63283348
Arthralgia 64.11 11.34 183 42243 569527 62877069
Rheumatoid arthritis 63.77 11.34 46 42380 253773 63192823
Lower respiratory tract infection 63.74 11.34 7 42419 132300 63314296
Drug dependence 63.38 11.34 80 42346 24403 63422193
Acute kidney injury 63.28 11.34 50 42376 263365 63183231
Insomnia 63.18 11.34 298 42128 214954 63231642
Bruxism 61.82 11.34 35 42391 3490 63443106
Chorea 60.87 11.34 27 42399 1597 63444999
Dyskinesia 60.78 11.34 90 42336 31912 63414684
Obsessive-compulsive disorder 59.80 11.34 36 42390 4024 63442572
Product administration error 57.69 11.34 73 42353 22324 63424272
Drug intolerance 57.65 11.34 73 42353 308588 63138008
Pre-eclampsia 57.12 11.34 48 42378 9085 63437511
Crying 56.85 11.34 74 42352 23269 63423327
Product colour issue 56.82 11.34 20 42406 637 63445959
Adhesive tape use 56.81 11.34 9 42417 0 63446596
Hallucination 56.74 11.34 118 42308 54699 63391897
Social anxiety disorder 56.72 11.34 18 42408 413 63446183
Headache 54.52 11.34 654 41772 632587 62814009
Infection 54.41 11.34 44 42382 229129 63217467
Memory impairment 54.14 11.34 173 42253 104085 63342511
Product administration interrupted 54.02 11.34 36 42390 4800 63441796
Completed suicide 53.67 11.34 216 42210 145457 63301139
Rapid eye movement sleep behaviour disorder 52.97 11.34 16 42410 310 63446286
Blister 51.08 11.34 12 42414 129802 63316794
Maternal exposure during breast feeding 50.85 11.34 33 42393 4208 63442388
Treatment failure 50.07 11.34 36 42390 199007 63247589
Hallucination, visual 49.86 11.34 63 42363 19235 63427361
Educational problem 49.51 11.34 16 42410 390 63446206
Product tampering 49.05 11.34 16 42410 402 63446194
Impulsive behaviour 48.89 11.34 23 42403 1560 63445036
Abdominal discomfort 48.24 11.34 88 42338 320797 63125799
Adulterated product 47.73 11.34 14 42412 244 63446352
Heart rate increased 46.78 11.34 154 42272 94084 63352512
Euphoric mood 46.61 11.34 33 42393 4854 63441742
Drug diversion 46.26 11.34 19 42407 929 63445667
Mood swings 46.24 11.34 59 42367 18189 63428407
General physical health deterioration 46.16 11.34 40 42386 201362 63245234
Bipolar disorder 46.04 11.34 40 42386 7920 63438676
Rash 45.84 11.34 206 42220 560665 62885931
Anaemia 45.43 11.34 79 42347 293351 63153245
Hepatic enzyme increased 45.39 11.34 41 42385 202287 63244309
Seizure 45.18 11.34 192 42234 132442 63314154
Claustrophobia 44.95 11.34 19 42407 999 63445597
Parasomnia 44.92 11.34 16 42410 528 63446068
Peripheral swelling 44.53 11.34 68 42358 265874 63180722
Snoring 43.88 11.34 30 42396 4172 63442424
Growth retardation 43.01 11.34 20 42406 1321 63445275
Neutropenia 42.28 11.34 33 42393 174972 63271624
Muscle contracture 42.04 11.34 20 42406 1391 63445205
Sleep-related eating disorder 41.33 11.34 17 42409 834 63445762
Anger 40.98 11.34 46 42380 12410 63434186
Febrile neutropenia 40.95 11.34 14 42412 118435 63328161
Application site pruritus 40.56 11.34 28 42398 3956 63442640
Palpitations 40.55 11.34 166 42260 112604 63333992
Perinatal depression 40.32 11.34 16 42410 715 63445881
Affective disorder 39.88 11.34 33 42393 6113 63440483
Depressed mood 39.83 11.34 85 42341 40106 63406490
Mobility decreased 39.07 11.34 16 42410 121143 63325453
Hypersomnia 39.01 11.34 54 42372 18001 63428595
Application site urticaria 38.86 11.34 12 42414 251 63446345
Restlessness 38.53 11.34 70 42356 29383 63417213
Emotional disorder 38.31 11.34 46 42380 13333 63433263
Lactation disorder 38.09 11.34 13 42413 377 63446219
Misophonia 37.87 11.34 6 42420 0 63446596
Splenic infarction 37.86 11.34 20 42406 1739 63444857
Exposure via breast milk 37.63 11.34 21 42405 2036 63444560
Blood pressure increased 37.49 11.34 210 42216 161852 63284744
Alopecia 37.45 11.34 109 42317 337427 63109169
Muscle twitching 36.89 11.34 55 42371 19613 63426983
Poor sucking reflex 36.84 11.34 12 42414 300 63446296
Hyperreflexia 36.72 11.34 31 42395 5903 63440693
Major depression 36.06 11.34 35 42391 7983 63438613
Hyperventilation 35.91 11.34 31 42395 6085 63440511
Haemoglobin decreased 35.69 11.34 27 42399 145458 63301138
Multiple sclerosis relapse 35.43 11.34 91 42335 48387 63398209
Mania 34.56 11.34 42 42384 12325 63434271
Livedo reticularis 34.37 11.34 21 42405 2411 63444185
Dyspnoea 34.00 11.34 281 42145 661032 62785564
Negative thoughts 33.43 11.34 15 42411 912 63445684
Migraine 33.18 11.34 147 42279 103199 63343397
Folliculitis 33.16 11.34 4 42422 70313 63376283
Somatic symptom disorder 32.64 11.34 21 42405 2639 63443957
Thrombocytopenia 32.28 11.34 32 42394 151125 63295471
Death 32.05 11.34 135 42291 374246 63072350
Feeling jittery 31.87 11.34 42 42384 13361 63433235
Weight decreased 31.68 11.34 303 42123 276495 63170101
Post-traumatic stress disorder 31.61 11.34 27 42399 5224 63441372
Application site rash 31.34 11.34 20 42406 2478 63444118
Exposure during pregnancy 31.10 11.34 194 42232 155353 63291243
Tardive dyskinesia 30.75 11.34 33 42393 8469 63438127
Muscle injury 30.12 11.34 4 42422 65341 63381255
Pulse abnormal 29.84 11.34 19 42407 2345 63444251
Discomfort 29.76 11.34 41 42385 167333 63279263
Pancytopenia 29.36 11.34 14 42412 96919 63349677
Impaired healing 29.28 11.34 16 42410 102526 63344070
Hyperhidrosis 29.22 11.34 146 42280 107690 63338906
Delusion of parasitosis 29.09 11.34 6 42420 20 63446576
Mood altered 28.76 11.34 42 42384 14701 63431895
Burnout syndrome 28.42 11.34 9 42417 205 63446391
Sleep paralysis 28.09 11.34 12 42414 648 63445948
Interstitial lung disease 28.04 11.34 4 42422 61904 63384692
Loss of consciousness 27.93 11.34 154 42272 117967 63328629
Drug hypersensitivity 27.86 11.34 110 42316 310577 63136019
Tachyphrenia 27.82 11.34 15 42411 1359 63445237
Trichotillomania 27.80 11.34 8 42418 130 63446466
Sepsis 27.74 11.34 37 42389 153086 63293510
Solar urticaria 27.27 11.34 7 42419 72 63446524
Nightmare 26.88 11.34 47 42379 19147 63427449
Meningitis streptococcal 26.78 11.34 8 42418 149 63446447
Serotonin syndrome 26.52 11.34 59 42367 28623 63417973
Drug withdrawal syndrome 26.35 11.34 57 42369 27137 63419459
Abnormal sleep-related event 25.97 11.34 12 42414 781 63445815
Pneumonia 25.80 11.34 189 42237 456578 62990018
Drug screen negative 25.56 11.34 9 42417 287 63446309
Hangover 25.38 11.34 15 42411 1621 63444975
Cardiac failure 25.32 11.34 14 42412 89128 63357468
Maternal exposure during pregnancy 25.16 11.34 70 42356 219992 63226604
Illness 25.08 11.34 81 42345 48978 63397618
Amenorrhoea 25.03 11.34 32 42394 9882 63436714
Narcolepsy 25.02 11.34 14 42412 1364 63445232
Multiple organ dysfunction syndrome 24.94 11.34 4 42422 56748 63389848
Chronic fatigue syndrome 24.88 11.34 13 42413 1105 63445491
Product taste abnormal 24.58 11.34 16 42410 2051 63444545
C-reactive protein increased 23.97 11.34 17 42409 94690 63351906
Psychiatric symptom 23.86 11.34 23 42403 5200 63441396
Surgery 23.79 11.34 65 42361 35847 63410749
Stress 23.44 11.34 98 42328 67069 63379527
Knee arthroplasty 23.42 11.34 4 42422 54202 63392394
Pyrexia 23.18 11.34 202 42224 470276 62976320
Cyanosis 23.11 11.34 41 42385 16894 63429702
Axonal neuropathy 23.08 11.34 12 42414 1010 63445586
Wound infection fungal 22.87 11.34 7 42419 142 63446454
Cardiac failure congestive 22.86 11.34 17 42409 92416 63354180
Therapeutic response changed 22.83 11.34 12 42414 1033 63445563
CSWS syndrome 22.62 11.34 5 42421 25 63446571
Tachypnoea 22.47 11.34 41 42385 17261 63429335
Open angle glaucoma 22.40 11.34 8 42418 266 63446330
Nystagmus 22.24 11.34 24 42402 6196 63440400
Neurological symptom 21.89 11.34 23 42403 5760 63440836
Logorrhoea 21.77 11.34 16 42410 2494 63444102
Formication 21.72 11.34 20 42406 4271 63442325
Ill-defined disorder 21.59 11.34 14 42412 81741 63364855
Hallucination, tactile 21.46 11.34 8 42418 301 63446295
Hyperkalaemia 21.33 11.34 5 42421 54198 63392398
Gastrointestinal haemorrhage 21.30 11.34 14 42412 81162 63365434
Incorrect product administration duration 21.24 11.34 32 42394 11514 63435082
Vision blurred 21.16 11.34 119 42307 91805 63354791
Septic shock 21.15 11.34 9 42417 66620 63379976
Cholestasis of pregnancy 21.04 11.34 12 42414 1213 63445383
Muscle spasms 20.94 11.34 177 42249 155973 63290623
Musculoskeletal stiffness 20.90 11.34 59 42367 184559 63262037
Libido decreased 20.87 11.34 16 42410 2656 63443940
Stomatitis 20.85 11.34 38 42388 138687 63307909
Amphetamines positive 20.78 11.34 7 42419 195 63446401
Initial insomnia 20.70 11.34 23 42403 6134 63440462
Acne 20.52 11.34 47 42379 23246 63423350
Nervousness 20.44 11.34 56 42370 30923 63415673
Optic disc haemorrhage 20.43 11.34 6 42420 105 63446491
Protrusion tongue 20.06 11.34 8 42418 362 63446234
Product prescribing error 19.88 11.34 50 42376 26239 63420357
Substance abuse 19.79 11.34 20 42406 4787 63441809
Renal impairment 19.68 11.34 18 42408 88337 63358259
Application site discolouration 19.58 11.34 10 42416 811 63445785
Dizziness 19.50 11.34 399 42027 429526 63017070
Social avoidant behaviour 19.30 11.34 16 42410 2972 63443624
Antiphospholipid syndrome 19.21 11.34 13 42413 1777 63444819
Eosinophilic myocarditis 19.12 11.34 9 42417 611 63445985
Compulsive lip biting 18.94 11.34 3 42423 0 63446596
Delusion 18.91 11.34 31 42395 11986 63434610
Foot fracture 18.63 11.34 46 42380 23868 63422728
Bezoar 18.61 11.34 12 42414 1514 63445082
Sensory level abnormal 18.50 11.34 6 42420 148 63446448
Application site pain 18.33 11.34 18 42408 4164 63442432
Learning disorder 18.27 11.34 9 42417 676 63445920
Brain injury 18.20 11.34 23 42403 7020 63439576
Food craving 18.05 11.34 12 42414 1594 63445002
Gastrointestinal disorder 17.95 11.34 38 42388 131201 63315395
Hunger 17.92 11.34 20 42406 5359 63441237
Renal failure 17.88 11.34 32 42394 117620 63328976
Psoriatic arthropathy 17.73 11.34 21 42405 91499 63355097
Decreased appetite 17.57 11.34 250 42176 250802 63195794
Hypersensitivity 17.53 11.34 119 42307 292566 63154030
Thinking abnormal 17.49 11.34 28 42398 10615 63435981
Atrial fibrillation 17.48 11.34 32 42394 116604 63329992
Product complaint 17.46 11.34 31 42395 12778 63433818
Platelet count decreased 17.28 11.34 32 42394 116090 63330506
Mental disorder 17.25 11.34 47 42379 25872 63420724
Mucosal inflammation 17.19 11.34 5 42421 46923 63399673
Bisexuality 16.86 11.34 3 42423 3 63446593
Hypotension 16.74 11.34 110 42316 272494 63174102
Gastric bypass 16.71 11.34 12 42414 1805 63444791
Product availability issue 16.70 11.34 17 42409 4104 63442492
Pseudoporphyria 16.65 11.34 6 42420 205 63446391
Rectal haemorrhage 16.59 11.34 6 42420 49024 63397572
Disease progression 16.41 11.34 36 42390 122722 63323874
Long QT syndrome congenital 16.40 11.34 5 42421 100 63446496
Pleural effusion 16.39 11.34 23 42403 93187 63353409
Akathisia 16.33 11.34 25 42401 9121 63437475
Pain 16.32 11.34 374 42052 740254 62706342
Respiratory failure 16.12 11.34 27 42399 101831 63344765
Raynaud's phenomenon 15.86 11.34 10 42416 1214 63445382
Leukopenia 15.77 11.34 17 42409 77273 63369323
Myoclonic epilepsy 15.63 11.34 10 42416 1244 63445352
Red blood cell sedimentation rate increased 15.54 11.34 5 42421 43977 63402619
Type 2 diabetes mellitus 15.47 11.34 12 42414 63856 63382740
Hepatotoxicity 15.43 11.34 3 42423 37038 63409558
Grimacing 15.42 11.34 7 42419 437 63446159
Congenital cystic lung 15.25 11.34 4 42422 45 63446551
Foetal exposure timing unspecified 15.21 11.34 6 42420 264 63446332
C-reactive protein abnormal 15.00 11.34 6 42420 46090 63400506
Schizoaffective disorder bipolar type 14.92 11.34 5 42421 137 63446459
Panic reaction 14.74 11.34 16 42410 4158 63442438
Heavy menstrual bleeding 14.71 11.34 35 42391 17738 63428858
Malignant neoplasm progression 14.70 11.34 20 42406 82101 63364495
Vasospasm 14.55 11.34 8 42418 754 63445842
Pruritus 14.51 11.34 163 42263 361290 63085306
Hallucinations, mixed 14.48 11.34 17 42409 4812 63441784
Body temperature increased 14.36 11.34 56 42370 37136 63409460
Hip arthroplasty 14.24 11.34 7 42419 47639 63398957
Lactic acidosis 14.17 11.34 4 42422 38283 63408313
Hyponatraemia 14.00 11.34 34 42392 111866 63334730
Affect lability 13.95 11.34 26 42400 11125 63435471
White blood cell count decreased 13.93 11.34 47 42379 139057 63307539
Irritable bowel syndrome 13.84 11.34 21 42405 82391 63364205
Brain death 13.70 11.34 14 42412 3396 63443200
Phobia 13.64 11.34 6 42420 348 63446248
Consciousness fluctuating 13.58 11.34 8 42418 859 63445737
Product dose omission issue 13.57 11.34 226 42200 234087 63212509
Oedema 13.57 11.34 28 42398 97594 63349002
Bursitis 13.47 11.34 4 42422 37037 63409559
Therapeutic product effect incomplete 13.39 11.34 41 42385 125015 63321581
Cerebral artery occlusion 13.35 11.34 8 42418 887 63445709
Muscle discomfort 13.29 11.34 5 42421 193 63446403
Pseudolymphoma 13.11 11.34 7 42419 622 63445974
Pelvic inflammatory disease 13.09 11.34 10 42416 1652 63444944
Hyperacusis 13.00 11.34 11 42415 2102 63444494
Serum serotonin decreased 12.84 11.34 3 42423 20 63446576
Nephrogenic diabetes insipidus 12.84 11.34 8 42418 951 63445645
Sleep attacks 12.81 11.34 4 42422 87 63446509
Oculogyric crisis 12.78 11.34 10 42416 1711 63444885
Muscle tightness 12.76 11.34 26 42400 11874 63434722
Status epilepticus 12.61 11.34 30 42396 15203 63431393
Intrusive thoughts 12.61 11.34 5 42421 223 63446373
Rash pruritic 12.37 11.34 13 42413 59786 63386810
Distractibility 12.34 11.34 6 42420 438 63446158
Foetal exposure during pregnancy 12.24 11.34 48 42378 31914 63414682
International normalised ratio increased 12.19 11.34 8 42418 46417 63400179
Amnesia 12.16 11.34 71 42355 55514 63391082
Horner's syndrome 12.15 11.34 3 42423 26 63446570
Therapy non-responder 12.12 11.34 20 42406 75881 63370715
Herpes zoster 12.02 11.34 23 42403 82439 63364157
Seizure like phenomena 11.97 11.34 8 42418 1071 63445525
Extrapyramidal disorder 11.92 11.34 27 42399 13257 63433339
Treatment noncompliance 11.90 11.34 53 42373 37272 63409324
Infected cyst 11.76 11.34 8 42418 1104 63445492
Drug abuser 11.74 11.34 12 42414 2911 63443685
Neutrophil percentage increased 11.67 11.34 12 42414 2931 63443665
Tongue biting 11.65 11.34 9 42417 1511 63445085
Menstrual disorder 11.64 11.34 16 42410 5297 63441299
Impulse-control disorder 11.62 11.34 7 42419 783 63445813
Prehypertension 11.59 11.34 3 42423 32 63446564
Bartonellosis 11.59 11.34 3 42423 32 63446564
External ear cellulitis 11.45 11.34 5 42421 285 63446311
Choreoathetosis 11.34 11.34 6 42420 523 63446073

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 905.34 13.08 433 42142 16602 34897754
Aggression 708.42 13.08 492 42083 38472 34875884
No adverse event 636.22 13.08 378 42197 22549 34891807
Tic 541.28 13.08 168 42407 1890 34912466
Agitation 465.17 13.08 453 42122 56946 34857410
Abnormal behaviour 436.44 13.08 308 42267 24661 34889695
Suicidal ideation 420.93 13.08 367 42208 40021 34874335
Product substitution issue 387.39 13.08 206 42369 9889 34904467
Irritability 357.77 13.08 272 42303 24418 34889938
Psychomotor hyperactivity 332 13.08 183 42392 9439 34904917
Application site erythema 317.12 13.08 116 42459 2220 34912136
Wrong technique in product usage process 308.23 13.08 293 42282 35693 34878663
Dyskinesia 266.84 13.08 220 42355 22193 34892163
Attention deficit hyperactivity disorder 264.03 13.08 104 42471 2455 34911901
Anxiety 243.52 13.08 435 42140 98993 34815363
Dystonia 242.61 13.08 156 42419 10689 34903667
Disturbance in attention 223.52 13.08 212 42363 25733 34888623
Growth retardation 222.37 13.08 84 42491 1764 34912592
Product administration error 214.79 13.08 170 42405 16174 34898182
Psychotic disorder 209.11 13.08 199 42376 24253 34890103
Acute kidney injury 206.91 13.08 58 42517 304930 34609426
Crying 200.84 13.08 111 42464 5751 34908605
Suicide attempt 192.91 13.08 238 42337 38878 34875478
Product administered at inappropriate site 189.83 13.08 79 42496 2157 34912199
Insomnia 180.86 13.08 394 42181 103513 34810843
Drug dependence 171.72 13.08 178 42397 24039 34890317
Application site irritation 171.29 13.08 54 42521 641 34913715
Intentional overdose 167.72 13.08 235 42340 43439 34870917
Choreoathetosis 167.62 13.08 59 42516 1005 34913351
Depression 166.48 13.08 366 42209 96732 34817624
Application site pruritus 164.55 13.08 63 42512 1374 34912982
Pneumonia 162.62 13.08 123 42452 362504 34551852
Death 152.05 13.08 157 42418 397892 34516464
Incorrect product administration duration 150.96 13.08 86 42489 4725 34909631
Anger 150.54 13.08 121 42454 11763 34902593
Tachycardia 148.07 13.08 322 42253 84450 34829906
Withdrawal syndrome 145.56 13.08 121 42454 12334 34902022
Drug abuse 137.59 13.08 344 42231 98752 34815604
Impulsive behaviour 136.53 13.08 62 42513 2100 34912256
Intentional product misuse 135.91 13.08 218 42357 45393 34868963
Hallucination, visual 130.14 13.08 133 42442 17658 34896698
Overdose 129.45 13.08 319 42256 90740 34823616
Intentional self-injury 123.29 13.08 115 42460 13656 34900700
Anaemia 122.39 13.08 66 42509 233269 34681087
Disturbance in social behaviour 116.63 13.08 53 42522 1798 34912558
Educational problem 115.34 13.08 38 42537 524 34913832
Product adhesion issue 114.22 13.08 50 42525 1550 34912806
Depressed mood 112.47 13.08 128 42447 19189 34895167
Paranoia 112.33 13.08 103 42472 11965 34902391
Drug ineffective 110.10 13.08 938 41637 455813 34458543
Drug diversion 109.55 13.08 41 42534 838 34913518
Hallucination 109.18 13.08 212 42363 51286 34863070
Toxicity to various agents 105.65 13.08 503 42072 199859 34714497
Trismus 104.46 13.08 54 42521 2441 34911915
Serotonin syndrome 104.25 13.08 125 42450 19808 34894548
Trichotillomania 102.78 13.08 23 42552 57 34914299
Coronary artery dissection 101.74 13.08 30 42545 279 34914077
Diarrhoea 100.24 13.08 203 42372 389709 34524647
Mydriasis 98.76 13.08 77 42498 7160 34907196
Priapism 95.11 13.08 65 42510 4929 34909427
Hypotension 94.31 13.08 79 42496 221570 34692786
Hallucination, auditory 92.48 13.08 92 42483 11825 34902531
Oppositional defiant disorder 92.46 13.08 32 42543 517 34913839
Affect lability 92.42 13.08 57 42518 3626 34910730
Dyspnoea 90.28 13.08 204 42371 376578 34537778
Palpitations 90.14 13.08 169 42406 39817 34874539
Sepsis 87.41 13.08 47 42528 166514 34747842
Emotional disorder 87.21 13.08 65 42510 5651 34908705
Homicidal ideation 86.99 13.08 49 42526 2633 34911723
Product complaint 83.27 13.08 64 42511 5826 34908530
Somnolence 80.97 13.08 308 42267 110808 34803548
Sleep disorder 80.41 13.08 141 42434 31547 34882809
Bruxism 79.76 13.08 40 42535 1695 34912661
Hallucination, tactile 78.97 13.08 25 42550 301 34914055
General physical health deterioration 76.91 13.08 30 42545 128239 34786117
Application site rash 75.18 13.08 31 42544 826 34913530
Mood altered 74.86 13.08 72 42503 8880 34905476
Therapeutic product effect decreased 74.79 13.08 144 42431 34599 34879757
Precocious puberty 74.10 13.08 20 42555 130 34914226
Hyperkinesia 73.25 13.08 38 42537 1730 34912626
Product prescribing error 72.97 13.08 113 42462 22814 34891542
Feeling abnormal 72.90 13.08 205 42370 63030 34851326
Febrile neutropenia 72.69 13.08 38 42537 136811 34777545
Logorrhoea 72.45 13.08 42 42533 2384 34911972
Gastrointestinal haemorrhage 71.77 13.08 11 42564 88466 34825890
Delusion 68.97 13.08 81 42494 12554 34901802
Decreased eye contact 68.73 13.08 25 42550 470 34913886
Pyrexia 68.31 13.08 195 42380 332818 34581538
Mania 67.55 13.08 70 42505 9441 34904915
Restlessness 66.75 13.08 115 42460 25367 34888989
Renal impairment 65.71 13.08 17 42558 94496 34819860
Renal failure 63.97 13.08 40 42535 130517 34783839
Thrombocytopenia 63.59 13.08 58 42517 156189 34758167
Headache 63 13.08 439 42136 200196 34714160
Decreased appetite 61.92 13.08 380 42195 166012 34748344
Oromandibular dystonia 61.09 13.08 23 42552 478 34913878
Interstitial lung disease 60.74 13.08 5 42570 65277 34849079
Multiple organ dysfunction syndrome 58.82 13.08 11 42564 76555 34837801
Euphoric mood 58.13 13.08 51 42524 5590 34908766
Cardiac failure congestive 57.84 13.08 15 42560 83255 34831101
Neutropenia 57.18 13.08 64 42511 156714 34757642
Platelet count decreased 56.85 13.08 38 42537 119679 34794677
Gynaecomastia 56.79 13.08 66 42509 10114 34904242
Apathy 56.54 13.08 55 42520 6877 34907479
Application site urticaria 56.00 13.08 14 42561 64 34914292
Speech disorder 55.93 13.08 107 42468 25579 34888777
Kounis syndrome 55.74 13.08 36 42539 2482 34911874
Dermo-hypodermitis 55.14 13.08 21 42554 451 34913905
Obsessive-compulsive disorder 54.74 13.08 49 42526 5515 34908841
Application site pain 54.26 13.08 32 42543 1876 34912480
Alice in wonderland syndrome 53.07 13.08 10 42565 5 34914351
Enuresis 52.98 13.08 34 42541 2319 34912037
Drug use disorder 51.64 13.08 42 42533 4149 34910207
Adhesive tape use 51.41 13.08 9 42566 0 34914356
Haemoglobin decreased 51.34 13.08 43 42532 120729 34793627
Product taste abnormal 50.85 13.08 26 42549 1148 34913208
Therapeutic response unexpected 50.69 13.08 61 42514 9696 34904660
Blood creatinine increased 49.48 13.08 27 42548 94949 34819407
Formication 49.33 13.08 29 42546 1690 34912666
Dermatillomania 48.90 13.08 12 42563 50 34914306
Drug screen negative 48.61 13.08 15 42560 165 34914191
Oedema peripheral 48.10 13.08 45 42530 119767 34794589
Suicidal behaviour 47.60 13.08 27 42548 1470 34912886
Mood swings 47.07 13.08 53 42522 7848 34906508
Product administered to patient of inappropriate age 47.05 13.08 36 42539 3255 34911101
Substance abuse 46.80 13.08 52 42523 7589 34906767
Respiratory failure 45.72 13.08 39 42536 108533 34805823
Torticollis 45.52 13.08 24 42551 1130 34913226
Pancytopenia 45.44 13.08 30 42545 95127 34819229
Atrial fibrillation 44.56 13.08 50 42525 122343 34792013
Social avoidant behaviour 44.38 13.08 34 42541 3080 34911276
Panic attack 44.22 13.08 56 42519 9376 34904980
Hyperkalaemia 43.64 13.08 15 42560 69374 34844982
Autism spectrum disorder 41.64 13.08 29 42546 2267 34912089
Bipolar disorder 41.52 13.08 35 42540 3634 34910722
Distractibility 41.40 13.08 16 42559 358 34913998
Raynaud's phenomenon 41.34 13.08 15 42560 280 34914076
Sleep apnoea syndrome 41.02 13.08 82 42493 20239 34894117
Completed suicide 40.84 13.08 231 42344 97937 34816419
Device difficult to use 39.91 13.08 31 42544 2866 34911490
White blood cell count decreased 39.31 13.08 35 42540 95410 34818946
Substance use disorder 38.90 13.08 19 42556 760 34913596
Generalised tonic-clonic seizure 38.68 13.08 82 42493 21092 34893264
Poisoning 38.53 13.08 60 42515 12166 34902190
Cardiac failure 38.14 13.08 33 42542 91215 34823141
Septic shock 38.03 13.08 20 42555 71814 34842542
Increased appetite 37.87 13.08 46 42529 7383 34906973
Asthenia 37.80 13.08 162 42413 245089 34669267
Extrapyramidal disorder 37.55 13.08 61 42514 12819 34901537
Hallucinations, mixed 37.53 13.08 29 42546 2660 34911696
Disease progression 37.35 13.08 46 42529 108031 34806325
Product use issue 37.09 13.08 164 42411 63052 34851304
Hypertension 36.73 13.08 288 42287 136155 34778201
Peripheral swelling 36.71 13.08 24 42551 76517 34837839
Tardive dyskinesia 36.49 13.08 40 42535 5750 34908606
Cataplexy 36.28 13.08 14 42561 312 34914044
Keratoconus 36.06 13.08 11 42564 116 34914240
Cough 36.03 13.08 81 42494 150059 34764297
Arthralgia 35.91 13.08 98 42477 169943 34744413
Joint swelling 35.87 13.08 14 42561 59876 34854480
Heart rate increased 35.81 13.08 131 42444 46212 34868144
Treatment noncompliance 35.24 13.08 94 42481 28006 34886350
Product colour issue 34.95 13.08 16 42559 552 34913804
Seizure 34.94 13.08 233 42342 104624 34809732
Hyponatraemia 34.44 13.08 30 42545 82661 34831695
Ventricular parasystole 34.27 13.08 6 42569 0 34914356
Drug withdrawal syndrome 34.16 13.08 75 42500 19759 34894597
Arteriospasm coronary 33.69 13.08 30 42545 3352 34911004
Coordination abnormal 33.66 13.08 44 42531 7600 34906756
Muscle contracture 33.12 13.08 20 42555 1224 34913132
Pain 32.89 13.08 133 42442 204542 34709814
Mental disorder 32.67 13.08 63 42512 15146 34899210
Screaming 32.32 13.08 21 42554 1463 34912893
Malignant neoplasm progression 32 13.08 36 42539 88010 34826346
Pre-existing condition improved 31.98 13.08 26 42549 2566 34911790
Drug tolerance 31.60 13.08 27 42548 2855 34911501
Infection 31.09 13.08 39 42536 90876 34823480
Infusion related reaction 30.81 13.08 13 42562 53044 34861312
Rebound effect 30.57 13.08 28 42547 3246 34911110
Nervousness 30.55 13.08 55 42520 12551 34901805
Tremor 30.26 13.08 188 42387 82399 34831957
Melaena 29.60 13.08 4 42571 35376 34878980
Chronic kidney disease 29.42 13.08 7 42568 41203 34873153
Phobia 29.33 13.08 10 42565 154 34914202
Incorrect dose administered 29.19 13.08 112 42463 40403 34873953
Affective disorder 29.01 13.08 31 42544 4329 34910027
Product dispensing error 29.01 13.08 37 42538 6237 34908119
Excessive eye blinking 29.01 13.08 14 42561 545 34913811
Pleural effusion 28.92 13.08 34 42541 81512 34832844
Sympathomimetic effect 28.56 13.08 5 42570 0 34914356
Onychophagia 28.53 13.08 8 42567 61 34914295
Gilbert's syndrome 28.37 13.08 7 42568 30 34914326
Rheumatoid arthritis 28.30 13.08 6 42569 38232 34876124
Self-injurious ideation 27.60 13.08 20 42555 1664 34912692
Tourette's disorder 27.56 13.08 8 42567 70 34914286
Fear 27.06 13.08 47 42528 10429 34903927
Substance-induced psychotic disorder 27.04 13.08 20 42555 1718 34912638
COVID-19 26.79 13.08 33 42542 77517 34836839
Thinking abnormal 26.52 13.08 35 42540 6102 34908254
Personality change 26.48 13.08 32 42543 5107 34909249
Peripheral coldness 26.29 13.08 38 42537 7213 34907143
Dysphemia 26.27 13.08 19 42556 1576 34912780
Ascites 26.11 13.08 12 42563 46559 34867797
Acute psychosis 25.99 13.08 20 42555 1823 34912533
Colitis 25.82 13.08 7 42568 37743 34876613
Hyperhidrosis 25.68 13.08 169 42406 75523 34838833
Oxygen saturation decreased 25.63 13.08 17 42558 53801 34860555
International normalised ratio increased 25.30 13.08 13 42562 47314 34867042
Constipation 25.28 13.08 84 42491 136898 34777458
Neuropathy peripheral 25.19 13.08 39 42536 83224 34831132
Mucosal inflammation 24.88 13.08 8 42567 38614 34875742
Application site erosion 24.85 13.08 8 42567 102 34914254
Somnambulism 24.35 13.08 24 42551 3048 34911308
Cerebral congestion 24.26 13.08 6 42569 26 34914330
Oculogyric crisis 24.11 13.08 18 42557 1568 34912788
Polydipsia psychogenic 24.10 13.08 8 42567 113 34914243
Multiple cardiac defects 24.04 13.08 7 42568 62 34914294
Change in sustained attention 23.79 13.08 5 42570 8 34914348
Erection increased 23.78 13.08 12 42563 515 34913841
Dehydration 23.77 13.08 80 42495 129889 34784467
Erythema 23.73 13.08 45 42530 88735 34825621
Abdominal distension 23.42 13.08 22 42553 58470 34855886
Fall 23.35 13.08 148 42427 202737 34711619
Metabolic acidosis 23.35 13.08 12 42563 43668 34870688
C-reactive protein increased 23.29 13.08 19 42556 54079 34860277
Daydreaming 23.09 13.08 12 42563 548 34913808
Device adhesion issue 23.08 13.08 22 42553 2682 34911674
Weight gain poor 22.93 13.08 15 42560 1057 34913299
Animal phobia 22.85 13.08 4 42571 0 34914356
Liver disorder 22.79 13.08 6 42569 32991 34881365
Regressive behaviour 22.64 13.08 6 42569 36 34914320
Delayed puberty 22.62 13.08 9 42566 218 34914138
Productive cough 22.38 13.08 9 42566 37804 34876552
Pain in extremity 22.37 13.08 79 42496 126434 34787922
Sudden death 22.33 13.08 54 42521 15147 34899209
Stereotypy 22.31 13.08 13 42562 745 34913611
Hypokalaemia 22.03 13.08 23 42552 58191 34856165
Blood urea increased 21.99 13.08 5 42570 30359 34883997
Tongue spasm 21.72 13.08 6 42569 43 34914313
Illusion 21.26 13.08 13 42562 814 34913542
Prostate cancer 21.03 13.08 11 42564 39638 34874718
Renal disorder 21.03 13.08 3 42572 25477 34888879
Blood creatine phosphokinase increased 20.96 13.08 109 42466 44748 34869608
Product residue present 20.93 13.08 21 42554 2725 34911631
Narcolepsy 20.86 13.08 11 42564 518 34913838
Neutrophil count decreased 20.72 13.08 19 42556 51085 34863271
Petit mal epilepsy 20.68 13.08 22 42553 3056 34911300
Cholestasis 20.41 13.08 4 42571 26944 34887412
Plasma cell myeloma 20.40 13.08 13 42562 42024 34872332
Negativism 20.27 13.08 10 42565 409 34913947
Pica 20.15 13.08 5 42570 22 34914334
Pericardial effusion 20.13 13.08 3 42572 24659 34889697
Weight increased 20.06 13.08 187 42388 92846 34821510
Hypocalcaemia 19.73 13.08 3 42572 24286 34890070
Drug reaction with eosinophilia and systemic symptoms 19.30 13.08 8 42567 33004 34881352
Wolff-Parkinson-White syndrome 19.23 13.08 8 42567 218 34914138
Application site scab 19.20 13.08 6 42569 69 34914287
Dissociative disorder 19.20 13.08 10 42565 459 34913897
School refusal 19.16 13.08 5 42570 28 34914328
Suspiciousness 19.15 13.08 9 42566 330 34914026
Drooling 18.98 13.08 22 42553 3360 34910996
Dyspnoea exertional 18.88 13.08 15 42560 43264 34871092
Urinary incontinence 18.68 13.08 58 42517 18816 34895540
Panic reaction 18.63 13.08 15 42560 1460 34912896
Accidental exposure to product by child 18.62 13.08 15 42560 1461 34912895
Migraine 18.51 13.08 55 42520 17423 34896933
Performance status decreased 18.51 13.08 24 42551 4113 34910243
Libido increased 18.43 13.08 12 42563 839 34913517
Coronary artery disease 18.38 13.08 19 42556 48286 34866070
Application site dryness 18.13 13.08 6 42569 84 34914272
Major depression 18.12 13.08 25 42550 4547 34909809
Urinary tract infection 18.07 13.08 48 42527 84033 34830323
Idiopathic intracranial hypertension 17.97 13.08 11 42564 690 34913666
Exposure via direct contact 17.85 13.08 5 42570 38 34914318
Chronic obstructive pulmonary disease 17.77 13.08 20 42555 48898 34865458
Chorea 17.50 13.08 13 42562 1124 34913232
Hypoxia 17.44 13.08 25 42550 55070 34859286
Physical assault 17.42 13.08 13 42562 1132 34913224
Acute respiratory distress syndrome 17.41 13.08 5 42570 25964 34888392
Drug resistance 17.37 13.08 5 42570 25922 34888434
Pulmonary embolism 17.26 13.08 54 42521 89692 34824664
Sexual dysfunction 17.23 13.08 29 42546 6274 34908082
Rash 17.14 13.08 181 42394 222571 34691785
Cardiac contusion 17.14 13.08 3 42572 0 34914356
Limb girth decreased 17.14 13.08 3 42572 0 34914356
Cerebral arteritis 17.14 13.08 3 42572 0 34914356
Pneumonitis 17.10 13.08 10 42565 33868 34880488
Hypoglycaemia 17.09 13.08 25 42550 54615 34859741
Scoliosis 17.09 13.08 19 42556 2774 34911582
Haematoma 17.04 13.08 5 42570 25600 34888756
Eye movement disorder 17.01 13.08 23 42552 4104 34910252
Depersonalisation/derealisation disorder 16.99 13.08 10 42565 584 34913772
Incorrect route of product administration 16.96 13.08 48 42527 14797 34899559
Application site discolouration 16.96 13.08 8 42567 296 34914060
Thrombosis 16.87 13.08 22 42553 50436 34863920
Sydenham's chorea 16.63 13.08 4 42571 15 34914341
Lung disorder 16.46 13.08 11 42564 34685 34879671
Lower respiratory tract infection 16.45 13.08 9 42566 31628 34882728
Therapeutic response changed 16.44 13.08 9 42566 457 34913899
Opisthotonus 16.42 13.08 9 42566 458 34913898
Back pain 16.05 13.08 85 42490 121704 34792652
Insulin resistance 16.04 13.08 10 42565 648 34913708
Application site ulcer 15.87 13.08 4 42571 19 34914337
Meningitis staphylococcal 15.81 13.08 5 42570 60 34914296
Bone marrow failure 15.69 13.08 8 42567 29245 34885111
Testicular failure 15.66 13.08 5 42570 62 34914294
Shock 15.59 13.08 5 42570 24174 34890182
Muscle twitching 15.58 13.08 37 42538 10261 34904095
Vasospasm 15.55 13.08 8 42567 358 34913998
Stubbornness 15.54 13.08 4 42571 21 34914335
Tri-iodothyronine increased 15.44 13.08 5 42570 65 34914291
Haemoptysis 15.43 13.08 12 42563 34994 34879362
Therapeutic product effect increased 15.31 13.08 10 42565 703 34913653
Poor quality product administered 15.31 13.08 15 42560 1892 34912464
Hepatic function abnormal 15.19 13.08 19 42556 44344 34870012
Dependence 15.18 13.08 12 42563 1138 34913218
Product dose omission issue 15.15 13.08 217 42358 119494 34794862
Dissociation 15.13 13.08 14 42561 1644 34912712
Rectal haemorrhage 15.12 13.08 16 42559 40233 34874123
Psychopathic personality 15.06 13.08 3 42572 3 34914353
Anorexia nervosa 15.06 13.08 3 42572 3 34914353
Hypomagnesaemia 15.04 13.08 4 42571 21847 34892509
Amnesia 14.88 13.08 68 42507 26495 34887861
Erectile dysfunction 14.82 13.08 57 42518 20580 34893776
Parasomnia 14.80 13.08 8 42567 396 34913960
Congestive cardiomyopathy 14.79 13.08 30 42545 7480 34906876
Stomatitis 14.77 13.08 18 42557 42496 34871860
Frustration tolerance decreased 14.76 13.08 17 42558 2579 34911777
Accommodation disorder 14.71 13.08 7 42568 264 34914092
Device breakage 14.68 13.08 16 42559 2284 34912072
Dysphoria 14.67 13.08 16 42559 2286 34912070
Strabismus 14.62 13.08 14 42561 1717 34912639
Vision blurred 14.61 13.08 101 42474 45862 34868494
Feeling jittery 14.55 13.08 21 42554 3982 34910374
Hypersexuality 14.39 13.08 13 42562 1480 34912876
Stress cardiomyopathy 14.34 13.08 15 42560 2044 34912312
Epiphyses delayed fusion 14.20 13.08 3 42572 5 34914351
Chills 14.06 13.08 51 42524 80992 34833364
Poor quality sleep 13.96 13.08 31 42544 8225 34906131
Therapeutic product effect delayed 13.91 13.08 12 42563 1286 34913070
Wrong product administered 13.86 13.08 24 42551 5310 34909046
Schizotypal personality disorder 13.85 13.08 3 42572 6 34914350
Application site laceration 13.85 13.08 3 42572 6 34914350
Initial insomnia 13.78 13.08 18 42557 3106 34911250
Prescribed overdose 13.73 13.08 36 42539 10611 34903745
Injection site abscess 13.73 13.08 10 42565 839 34913517
Blood growth hormone decreased 13.68 13.08 4 42571 36 34914320
Agranulocytosis 13.56 13.08 6 42569 23815 34890541
Myocarditis 13.50 13.08 42 42533 13640 34900716
Arthropathy 13.50 13.08 8 42567 26899 34887457
Electrocardiogram T wave inversion 13.35 13.08 15 42560 2216 34912140
Pressure of speech 13.29 13.08 8 42567 487 34913869
Accidental exposure to product 13.28 13.08 40 42535 12762 34901594
Akathisia 13.21 13.08 30 42545 8079 34906277
Ataxia 13.18 13.08 42 42533 13811 34900545

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 740.69 11.43 475 62291 50483 79631139
Agitation 632.63 11.43 566 62200 99149 79582473
Suicidal ideation 601.99 11.43 491 62275 75849 79605773
Product substitution issue 550.42 11.43 284 62482 19972 79661650
Tic 509.42 11.43 158 62608 2828 79678794
Abnormal behaviour 478.96 11.43 319 62447 36102 79645520
Irritability 430.07 11.43 313 62453 40831 79640791
Product quality issue 424.06 11.43 288 62478 33652 79647970
Anxiety 323.02 11.43 646 62120 247866 79433756
Attention deficit hyperactivity disorder 315.73 11.43 113 62653 3196 79678426
No adverse event 311.57 11.43 248 62518 36944 79644678
Dystonia 299.66 11.43 195 62571 21204 79660418
Tachycardia 293.22 11.43 512 62254 177256 79504366
Psychomotor hyperactivity 292.54 11.43 176 62590 16673 79664949
Dyskinesia 289.26 11.43 257 62509 44516 79637106
Disturbance in attention 276.56 11.43 265 62501 50536 79631086
Intentional overdose 269.80 11.43 373 62393 105587 79576035
Toxicity to various agents 263.91 11.43 829 61937 420711 79260911
Suicide attempt 243.42 11.43 313 62453 82619 79599003
Depression 228.82 11.43 518 62248 216272 79465350
Psychotic disorder 215.98 11.43 211 62555 41191 79640431
Intentional self-injury 215.19 11.43 189 62577 32230 79649392
Drug abuse 207.62 11.43 420 62346 162271 79519351
Overdose 198.62 11.43 444 62322 183762 79497860
Insomnia 189.30 11.43 520 62246 244650 79436972
Withdrawal syndrome 183.14 11.43 159 62607 26695 79654927
Acute kidney injury 180.41 11.43 92 62674 519312 79162310
Mydriasis 174.75 11.43 130 62636 17513 79664109
Hallucination, visual 172.94 11.43 168 62598 32561 79649061
Intentional product misuse 168.43 11.43 283 62483 94882 79586740
Choreoathetosis 166.49 11.43 58 62708 1512 79680110
Drug dependence 166.13 11.43 182 62584 40587 79641035
Crying 164.37 11.43 140 62626 22903 79658719
Educational problem 162.42 11.43 42 62724 372 79681250
Precocious puberty 161.15 11.43 40 62726 295 79681327
Paranoia 155.10 11.43 126 62640 19306 79662316
Growth retardation 154.42 11.43 58 62708 1885 79679737
Application site erythema 154.37 11.43 77 62689 5033 79676589
Hallucination 153.08 11.43 256 62510 85489 79596133
Anger 144.88 11.43 115 62651 17047 79664575
Hallucination, auditory 142.06 11.43 123 62643 20570 79661052
Impulsive behaviour 135.19 11.43 59 62707 2841 79678781
Product administration error 129.45 11.43 142 62624 31704 79649918
Somnolence 125.95 11.43 444 62322 238537 79443085
Diarrhoea 125.31 11.43 322 62444 880167 78801455
Serotonin syndrome 122.82 11.43 164 62602 44863 79636759
Anaemia 121.69 11.43 103 62663 444912 79236710
Wrong technique in product usage process 120.58 11.43 212 62554 73663 79607959
Tremor 119.65 11.43 349 62417 169734 79511888
Joint swelling 117.99 11.43 40 62726 288606 79393016
Completed suicide 108.99 11.43 432 62334 245335 79436287
Product administered at inappropriate site 108.83 11.43 56 62710 3909 79677713
Trismus 107.73 11.43 62 62704 5405 79676217
Priapism 107.66 11.43 58 62708 4447 79677175
Synovitis 104.72 11.43 3 62763 150731 79530891
Apathy 103.25 11.43 84 62682 12893 79668729
Muscle contracture 101.10 11.43 45 62721 2272 79679350
Enuresis 99.32 11.43 49 62717 3127 79678495
Hallucination, tactile 98.74 11.43 31 62735 578 79681044
Mania 96.95 11.43 94 62672 18166 79663456
Mood altered 96.88 11.43 93 62673 17754 79663868
Bruxism 96.68 11.43 52 62714 3974 79677648
Pneumonia 96.45 11.43 238 62528 660008 79021614
Oppositional defiant disorder 96.27 11.43 29 62737 468 79681154
Affect lability 96.22 11.43 76 62690 11183 79670439
Death 91.79 11.43 193 62573 566321 79115301
Depressed mood 90.86 11.43 148 62618 48332 79633290
General physical health deterioration 90.65 11.43 52 62714 275186 79406436
Coronary artery dissection 90.37 11.43 34 62732 1110 79680512
Homicidal ideation 89.65 11.43 47 62719 3410 79678212
Application site irritation 89.57 11.43 38 62728 1706 79679916
Trichotillomania 87.96 11.43 22 62744 168 79681454
Emotional disorder 87.77 11.43 80 62686 14307 79667315
Incorrect product administration duration 87.69 11.43 74 62692 11948 79669674
Euphoric mood 85.75 11.43 61 62705 7665 79673957
Cataplexy 85.73 11.43 31 62735 903 79680719
Hyperkinesia 85.03 11.43 42 62724 2687 79678935
Delusion 84.62 11.43 92 62674 20331 79661291
Restlessness 84.53 11.43 140 62626 46352 79635270
Contraindicated product administered 84.07 11.43 12 62754 157526 79524096
Dyspnoea 79.51 11.43 376 62390 856649 78824973
Peripheral swelling 79.17 11.43 58 62708 269559 79412063
Arthralgia 78.92 11.43 212 62554 571591 79110031
Pulmonary malformation 78.74 11.43 21 62745 212 79681410
Obsessive-compulsive disorder 78.06 11.43 52 62714 5875 79675747
Feeling abnormal 77.19 11.43 288 62478 158911 79522711
Drug diversion 76.95 11.43 31 62735 1219 79680403
Palpitations 75.21 11.43 245 62521 126365 79555257
Infusion related reaction 75.09 11.43 44 62722 230193 79451429
Arthropathy 75.07 11.43 23 62743 177088 79504534
Chorea 74.72 11.43 37 62729 2380 79679242
Logorrhoea 71.65 11.43 44 62722 4321 79677301
Tardive dyskinesia 70.87 11.43 62 62704 10509 79671113
Febrile neutropenia 70.03 11.43 48 62718 230951 79450671
Drug intolerance 69.84 11.43 63 62703 264056 79417566
Decreased eye contact 69.39 11.43 26 62740 839 79680783
Thrombocytopenia 69.28 11.43 64 62702 265195 79416427
Rheumatoid arthritis 69.17 11.43 39 62727 208431 79473191
Panic attack 68.80 11.43 90 62676 24126 79657496
Neutropenia 67.66 11.43 76 62690 287634 79393988
Seizure 67.46 11.43 311 62455 188523 79493099
Heart rate increased 66.72 11.43 228 62538 120496 79561126
Application site pruritus 66.64 11.43 40 62726 3770 79677852
Interstitial lung disease 66.53 11.43 6 62760 112594 79569028
Sepsis 65.76 11.43 69 62697 269359 79412263
Systemic lupus erythematosus 65.17 11.43 9 62757 121140 79560482
Headache 64.72 11.43 792 61974 652980 79028642
Infection 64.69 11.43 57 62709 241655 79439967
Mood swings 64.59 11.43 79 62687 19801 79661821
Lower respiratory tract infection 64.13 11.43 12 62754 129208 79552414
Gynaecomastia 63.82 11.43 51 62715 7630 79673992
Swelling 63.11 11.43 47 62719 216664 79464958
Product adhesion issue 62.35 11.43 34 62732 2670 79678952
Hypotension 61.64 11.43 162 62604 440155 79241467
Gastrointestinal haemorrhage 61.14 11.43 20 62746 147699 79533923
Sleep apnoea syndrome 59.91 11.43 105 62661 36373 79645249
Somnambulism 58.54 11.43 43 62723 5678 79675944
Lung cyst 58.50 11.43 18 62748 313 79681309
Cardiac failure congestive 57.68 11.43 20 62746 142382 79539240
Glossodynia 57.21 11.43 7 62759 103330 79578292
Drug withdrawal syndrome 57.10 11.43 100 62666 34618 79647004
Treatment failure 56.40 11.43 32 62734 170454 79511168
Renal impairment 56.06 11.43 27 62739 157756 79523866
Extrapyramidal disorder 54.90 11.43 78 62688 22601 79659021
Multiple organ dysfunction syndrome 53.94 11.43 14 62752 120232 79561390
Substance abuse 53.66 11.43 53 62713 10473 79671149
Product taste abnormal 53.60 11.43 29 62737 2242 79679380
Dermo-hypodermitis 53.59 11.43 21 62745 767 79680855
Pericarditis 53.20 11.43 9 62757 104227 79577395
Adhesive tape use 52.75 11.43 9 62757 3 79681619
Kounis syndrome 52.65 11.43 36 62730 4246 79677376
Pyrexia 51.63 11.43 318 62448 678391 79003231
Alice in wonderland syndrome 51.00 11.43 11 62755 39 79681583
Oromandibular dystonia 50.87 11.43 22 62744 1036 79680586
Hyperhidrosis 50.80 11.43 245 62521 151247 79530375
Haemoglobin decreased 49.70 11.43 61 62705 222058 79459564
Muscle twitching 49.68 11.43 78 62688 24686 79656936
Platelet count decreased 49.60 11.43 48 62718 194616 79487006
Therapeutic response unexpected 48.88 11.43 69 62697 19877 79661745
Social anxiety disorder 48.88 11.43 18 62748 553 79681069
Affective disorder 48.30 11.43 45 62721 8274 79673348
Pancytopenia 48.18 11.43 36 62730 165709 79515913
Hallucinations, mixed 47.33 11.43 41 62725 6858 79674764
Decreased appetite 46.90 11.43 443 62323 341975 79339647
Substance use disorder 46.72 11.43 20 62746 918 79680704
Social avoidant behaviour 46.61 11.43 35 62731 4779 79676843
Generalised tonic-clonic seizure 46.28 11.43 105 62661 43805 79637817
Product tampering 46.11 11.43 16 62750 412 79681210
Respiratory tract malformation 45.94 11.43 12 62754 111 79681511
Mobility decreased 44.80 11.43 20 62746 122155 79559467
Rapid eye movement sleep behaviour disorder 44.78 11.43 16 62750 450 79681172
Hyperkalaemia 44.74 11.43 17 62749 114381 79567241
Wound 44.23 11.43 18 62748 116161 79565461
Application site rash 44.21 11.43 25 62741 2107 79679515
Adulterated product 43.67 11.43 14 62752 280 79681342
Cardiac failure 43.27 11.43 35 62731 154807 79526815
Poisoning 43.13 11.43 74 62692 25198 79656424
Blister 43.12 11.43 20 62746 119456 79562166
Ventricular parasystole 43.04 11.43 7 62759 0 79681622
Maternal exposure during breast feeding 42.99 11.43 27 62739 2758 79678864
Respiratory failure 42.27 11.43 48 62718 180863 79500759
Product administered to patient of inappropriate age 42.19 11.43 35 62731 5518 79676104
Renal failure 42.07 11.43 58 62708 200910 79480712
Drug use disorder 41.23 11.43 42 62724 8609 79673013
Increased appetite 41.20 11.43 49 62717 11929 79669693
Drug hypersensitivity 41.01 11.43 111 62655 298805 79382817
Claustrophobia 40.93 11.43 20 62746 1250 79680372
Keratoconus 40.64 11.43 11 62755 118 79681504
Somatic symptom disorder 40.18 11.43 25 62741 2512 79679110
Poor sucking reflex 40.15 11.43 11 62755 124 79681498
Bipolar disorder 39.65 11.43 39 62727 7668 79673954
Atrial fibrillation 39.56 11.43 59 62707 197827 79483795
Speech disorder 39.46 11.43 113 62653 54332 79627290
Rash 39.39 11.43 280 62486 578078 79103544
Suicidal behaviour 39.21 11.43 27 62739 3220 79678402
Formication 38.88 11.43 32 62734 4991 79676631
Lactation disorder 37.72 11.43 12 62754 234 79681388
Application site urticaria 37.62 11.43 12 62754 236 79681386
Nervousness 37.57 11.43 82 62684 33333 79648289
Therapeutic response changed 37.52 11.43 19 62747 1282 79680340
Sleep disorder 37.41 11.43 150 62616 85527 79596095
Change in sustained attention 37.26 11.43 7 62759 9 79681613
Oculogyric crisis 36.72 11.43 25 62741 2927 79678695
Septic shock 36.56 11.43 26 62740 122775 79558847
Torticollis 36.49 11.43 23 62743 2364 79679258
Hepatic enzyme increased 35.96 11.43 55 62711 182555 79499067
Feeling jittery 35.35 11.43 47 62719 12794 79668828
Pain 35.31 11.43 369 62397 703433 78978189
Disturbance in social behaviour 35.03 11.43 30 62736 4940 79676682
Vision blurred 34.58 11.43 170 62596 105728 79575894
Mental disorder 34.27 11.43 76 62690 31226 79650396
Distractibility 34.22 11.43 15 62751 730 79680892
Pre-existing condition improved 34.06 11.43 31 62735 5532 79676090
Oedema peripheral 33.62 11.43 95 62671 252193 79429429
Memory impairment 33.42 11.43 175 62591 111559 79570063
Petit mal epilepsy 33.29 11.43 31 62735 5696 79675926
Exposure via breast milk 33.04 11.43 16 62750 980 79680642
Hyponatraemia 32.73 11.43 56 62710 177792 79503830
Arteriospasm coronary 32.73 11.43 33 62733 6683 79674939
Akathisia 32.68 11.43 46 62720 13213 79668409
Raynaud's phenomenon 32.41 11.43 16 62750 1022 79680600
Hypersomnia 32.28 11.43 62 62704 23024 79658598
Loss of consciousness 31.91 11.43 234 62532 167709 79513913
Treatment noncompliance 31.79 11.43 102 62664 52166 79629456
Incorrect dose administered 31.74 11.43 132 62634 76498 79605124
Pleural effusion 31.33 11.43 41 62725 145221 79536401
School refusal 31.04 11.43 7 62759 32 79681590
Sudden death 30.92 11.43 60 62706 22451 79659171
Stereotypy 30.81 11.43 15 62751 930 79680692
Malignant neoplasm progression 30.77 11.43 37 62729 135953 79545669
Misophonia 30.74 11.43 5 62761 0 79681622
Dermatillomania 30.74 11.43 10 62756 210 79681412
Negative thoughts 30.63 11.43 17 62749 1382 79680240
White blood cell count decreased 30.52 11.43 64 62702 188224 79493398
Disease progression 30.44 11.43 62 62704 184300 79497322
C-reactive protein increased 30.39 11.43 34 62732 128993 79552629
Screaming 30.32 11.43 25 62741 3908 79677714
Excessive eye blinking 30.12 11.43 18 62748 1683 79679939
Hypertension 30.07 11.43 395 62371 330597 79351025
Thinking abnormal 30.01 11.43 44 62722 13117 79668505
Hyperventilation 29.99 11.43 34 62732 7865 79673757
Product dispensing error 29.75 11.43 44 62722 13219 79668403
Drug reaction with eosinophilia and systemic symptoms 29.74 11.43 7 62759 64237 79617385
Pre-eclampsia 29.66 11.43 32 62734 7009 79674613
Hepatotoxicity 29.63 11.43 3 62763 51349 79630273
Blood creatinine increased 29.30 11.43 48 62718 155009 79526613
Drug tolerance 29.04 11.43 35 62731 8640 79672982
Application site discolouration 29.03 11.43 14 62752 850 79680772
Peripheral coldness 28.90 11.43 48 62718 15922 79665700
Abdominal discomfort 28.77 11.43 101 62665 250626 79430996
Sleep-related eating disorder 28.40 11.43 13 62753 701 79680921
Hyperreflexia 28.34 11.43 34 62732 8351 79673271
Mucosal inflammation 28.30 11.43 12 62754 75568 79606054
Solar urticaria 28.08 11.43 8 62758 105 79681517
Parasomnia 28.07 11.43 12 62754 549 79681073
Autism spectrum disorder 28.00 11.43 15 62751 1137 79680485
Delayed puberty 27.93 11.43 9 62757 183 79681439
Eye movement disorder 27.93 11.43 33 62733 7978 79673644
Inflammation 27.71 11.43 20 62746 93733 79587889
Tachypnoea 27.70 11.43 71 62695 31992 79649630
Status epilepticus 27.64 11.43 61 62705 24980 79656642
Melaena 27.47 11.43 7 62759 60883 79620739
Protrusion tongue 27.22 11.43 11 62755 436 79681186
CSWS syndrome 27.05 11.43 6 62760 25 79681597
Product complaint 26.71 11.43 42 62724 13307 79668315
Blood creatine phosphokinase increased 26.71 11.43 113 62653 65977 79615645
Cough 26.70 11.43 174 62592 366615 79315007
International normalised ratio increased 26.47 11.43 17 62749 84704 79596918
Coordination abnormal 26.08 11.43 48 62718 17264 79664358
Product prescribing error 25.94 11.43 86 62680 44727 79636895
Rectal haemorrhage 25.69 11.43 14 62752 76286 79605336
Vasospasm 25.43 11.43 14 62752 1120 79680502
Erection increased 25.40 11.43 10 62756 370 79681252
Stomatitis 25.40 11.43 48 62718 146709 79534913
Nightmare 25.23 11.43 60 62706 25801 79655821
Substance-induced psychotic disorder 25.00 11.43 21 62745 3368 79678254
Major depression 24.92 11.43 33 62733 8947 79672675
Multiple sclerosis relapse 24.92 11.43 87 62679 46446 79635176
Erythema 24.91 11.43 91 62675 223199 79458423
Panic reaction 24.73 11.43 24 62742 4641 79676981
Personality change 24.65 11.43 35 62731 10135 79671487
Body temperature increased 24.61 11.43 84 62682 44336 79637286
Testicular failure 24.59 11.43 4 62762 0 79681622
Cardiac contusion 24.59 11.43 4 62762 0 79681622
Urine amphetamine negative 24.59 11.43 4 62762 0 79681622
Meningitis streptococcal 24.50 11.43 8 62758 170 79681452
Tachyphrenia 24.42 11.43 17 62749 2063 79679559
Impaired healing 24.25 11.43 20 62746 87635 79593987
Maternal exposure during pregnancy 24.21 11.43 44 62722 136494 79545128
Migraine 24.10 11.43 134 62632 87359 79594263
Dehydration 24 11.43 107 62659 248080 79433542
Wolff-Parkinson-White syndrome 23.92 11.43 9 62757 294 79681328
Narcolepsy 23.79 11.43 14 62752 1272 79680350
Self-injurious ideation 23.71 11.43 21 62745 3617 79678005
Strabismus 23.68 11.43 18 62748 2503 79679119
Fear 23.64 11.43 53 62713 21933 79659689
Hunger 23.44 11.43 25 62741 5403 79676219
Initial insomnia 23.23 11.43 28 62738 6910 79674712
Polydipsia psychogenic 23.05 11.43 8 62758 206 79681416
Foetal exposure timing unspecified 23.02 11.43 6 62760 55 79681567
Burnout syndrome 23.01 11.43 9 62757 327 79681295
Bone marrow failure 22.82 11.43 6 62760 51101 79630521
Hypersexuality 22.75 11.43 15 62751 1665 79679957
Wound infection fungal 22.70 11.43 8 62758 216 79681406
Oedema 22.60 11.43 37 62729 119543 79562079
Product administration interrupted 22.46 11.43 21 62745 3878 79677744
Optic disc haemorrhage 22.17 11.43 7 62759 133 79681489
Coronary artery disease 22.06 11.43 12 62754 65462 79616160
Hypocalcaemia 22.03 11.43 6 62760 49918 79631704
Hangover 21.89 11.43 16 62750 2096 79679526
Tongue biting 21.83 11.43 16 62750 2105 79679517
Poor quality product administered 21.71 11.43 20 62746 3625 79677997
Osteoarthritis 21.68 11.43 22 62744 87287 79594335
Product dose omission issue 21.46 11.43 293 62473 247244 79434378
Compulsions 21.32 11.43 9 62757 399 79681223
Osteoporosis 21.22 11.43 8 62758 54104 79627518
Chronic kidney disease 21.04 11.43 13 62753 66141 79615481
Pulse abnormal 21.00 11.43 19 62747 3365 79678257
Neurological symptom 20.95 11.43 30 62736 8753 79672869
Pruritus 20.94 11.43 204 62562 394444 79287178
Amenorrhoea 20.94 11.43 28 62738 7664 79673958
Surgery 20.89 11.43 65 62701 32701 79648921
Ill-defined disorder 20.88 11.43 13 62753 65862 79615760
Dysphoria 20.79 11.43 22 62744 4712 79676910
Congestive cardiomyopathy 20.77 11.43 35 62731 11745 79669877
Agranulocytosis 20.66 11.43 5 62761 45025 79636597
Chronic fatigue syndrome 20.65 11.43 13 62753 1334 79680288
Upper gastrointestinal haemorrhage 20.19 11.43 4 62762 41376 79640246
Persecutory delusion 20.13 11.43 22 62744 4887 79676735
Drug screen negative 20.12 11.43 8 62758 304 79681318
Product colour issue 20.11 11.43 11 62755 869 79680753
Scoliosis 20.06 11.43 27 62739 7437 79674185
Cyanosis 19.95 11.43 54 62712 25128 79656494
Sympathomimetic effect 19.85 11.43 6 62760 98 79681524
Psychiatric symptom 19.75 11.43 26 62740 7009 79674613
Splenic infarction 19.71 11.43 19 62747 3645 79677977
Grimacing 19.66 11.43 10 62756 681 79680941
Onychophagia 19.52 11.43 6 62760 104 79681518
Liver disorder 19.45 11.43 17 62749 72400 79609222
Myelosuppression 19.44 11.43 4 62762 40292 79641330
Alopecia 19.33 11.43 105 62661 231250 79450372
Accidental exposure to product by child 19.29 11.43 17 62749 2909 79678713
Constipation 19.23 11.43 137 62629 282913 79398709
Cataract subcapsular 19.21 11.43 11 62755 950 79680672
Tongue spasm 19.20 11.43 6 62760 110 79681512
Asthenia 18.95 11.43 286 62480 511403 79170219
Wrong product administered 18.93 11.43 29 62737 8983 79672639
Electrocardiogram QRS complex prolonged 18.85 11.43 32 62734 10801 79670821
Hypersensitivity 18.77 11.43 125 62641 262114 79419508
Irritable bowel syndrome 18.75 11.43 13 62753 62228 79619394
Hypoglycaemia 18.68 11.43 32 62734 101562 79580060
Hepatic function abnormal 18.64 11.43 18 62748 73089 79608533
Gastrointestinal disorder 18.59 11.43 43 62723 122162 79559460
Weight gain poor 18.53 11.43 11 62755 1016 79680606
Toxic epidermal necrolysis 18.50 11.43 6 62760 44575 79637047
Animal phobia 18.44 11.43 3 62763 0 79681622
Limb girth decreased 18.44 11.43 3 62763 0 79681622
Cerebral arteritis 18.44 11.43 3 62763 0 79681622
Herpes zoster 18.35 11.43 28 62738 93055 79588567
Dissociation 18.22 11.43 19 62747 4002 79677620
Talipes 18.18 11.43 6 62760 132 79681490
Cerebral congestion 18.04 11.43 5 62761 59 79681563
Hypokalaemia 17.90 11.43 56 62710 143984 79537638
Pericardial effusion 17.86 11.43 7 62759 46230 79635392
Ascites 17.69 11.43 20 62746 75542 79606080
Illusion 17.62 11.43 13 62753 1728 79679894
Oxygen saturation decreased 17.62 11.43 48 62718 128999 79552623
Acute psychosis 17.61 11.43 19 62747 4161 79677461
Phobia 17.54 11.43 8 62758 428 79681194
Substance abuser 17.50 11.43 6 62760 149 79681473
Sleep paralysis 17.48 11.43 9 62757 629 79680993
Atrioventricular block second degree 17.48 11.43 25 62741 7287 79674335
Open angle glaucoma 17.35 11.43 8 62758 439 79681183
Eosinophilia 17.29 11.43 7 62759 45338 79636284
Sinus tachycardia 17.22 11.43 66 62700 36842 79644780
Foetal exposure during pregnancy 17.20 11.43 22 62744 5768 79675854
Electrocardiogram QT prolonged 17.19 11.43 126 62640 90260 79591362
Hyperphagia 17.17 11.43 15 62751 2537 79679085
Lactic acidosis 17.16 11.43 18 62748 70341 79611281
Drug ineffective 16.98 11.43 1025 61741 1079888 78601734
Disinhibition 16.94 11.43 15 62751 2583 79679039
Neutrophil count decreased 16.90 11.43 30 62736 93929 79587693
Sensory level abnormal 16.85 11.43 6 62760 167 79681455
Daydreaming 16.85 11.43 10 62756 923 79680699
Psoriatic arthropathy 16.83 11.43 22 62744 77977 79603645
Hypoxia 16.80 11.43 35 62731 103208 79578414
Dysphemia 16.76 11.43 17 62749 3467 79678155
Opisthotonus 16.74 11.43 9 62757 687 79680935
Hypomagnesaemia 16.70 11.43 8 62758 46903 79634719
Tourette's disorder 16.58 11.43 5 62761 81 79681541
Product residue present 16.55 11.43 17 62749 3519 79678103
Drug eruption 16.41 11.43 7 62759 43928 79637694
Bisexuality 16.37 11.43 3 62763 3 79681619
Cholestasis of pregnancy 16.27 11.43 10 62756 983 79680639
Hypokinesia 16.25 11.43 42 62724 19018 79662604
Hypnagogic hallucination 16.18 11.43 6 62760 188 79681434
Livedo reticularis 16.16 11.43 18 62748 4085 79677537
Gastric bypass 16.14 11.43 11 62755 1290 79680332
Lung disorder 16.10 11.43 24 62742 80533 79601089
Knee arthroplasty 15.97 11.43 7 62759 43241 79638381
Application site pain 15.64 11.43 19 62747 4728 79676894
Nystagmus 15.60 11.43 28 62738 9876 79671746
Arthritis 15.48 11.43 43 62723 114837 79566785
Bundle branch block right 15.46 11.43 30 62736 11221 79670401
Meningitis staphylococcal 15.37 11.43 5 62761 105 79681517
Dissociative disorder 15.35 11.43 9 62757 812 79680810
Poor quality sleep 15.35 11.43 46 62720 22676 79658946
Concussion 15.14 11.43 27 62739 9476 79672146
Electroencephalogram abnormal 15.13 11.43 20 62746 5414 79676208
Injection site pain 15.08 11.43 52 62714 129786 79551836
Hepatitis 15.06 11.43 13 62753 55714 79625908
Amnesia 15.05 11.43 93 62673 62964 79618658
Urinary incontinence 15.04 11.43 68 62698 40841 79640781
Hyperglycaemia 15.01 11.43 20 62746 70315 79611307
Negativism 14.94 11.43 9 62757 854 79680768
Plasma cell myeloma 14.92 11.43 12 62754 53247 79628375
Tooth discolouration 14.87 11.43 10 62756 1147 79680475
Hyperacusis 14.82 11.43 13 62753 2210 79679412
Staring 14.76 11.43 14 62752 2631 79678991
Chronic obstructive pulmonary disease 14.72 11.43 28 62738 85391 79596231
Myocarditis 14.68 11.43 44 62722 21689 79659933
Anaphylactic shock 14.66 11.43 5 62761 35991 79645631
Rash pruritic 14.65 11.43 21 62745 71608 79610014
Myelodysplastic syndrome 14.63 11.43 3 62763 30298 79651324
Dyspnoea exertional 14.61 11.43 29 62737 87044 79594578
Sudden onset of sleep 14.58 11.43 8 62758 636 79680986
Epiphyses delayed fusion 14.55 11.43 3 62763 8 79681614
Antiphospholipid syndrome 14.54 11.43 12 62754 1879 79679743
Psychotic symptom 14.53 11.43 14 62752 2683 79678939
Musculoskeletal stiffness 14.30 11.43 80 62686 174928 79506694
Schizotypal personality disorder 14.29 11.43 3 62763 9 79681613
Brain oedema 14.19 11.43 48 62718 25215 79656407
Thrombosis 14.12 11.43 28 62738 84072 79597550
Rash maculo-papular 14.07 11.43 14 62752 56064 79625558
Psoriasis 14.05 11.43 31 62735 89556 79592066
Neoplasm progression 14.04 11.43 12 62754 51670 79629952
Physical assault 14.03 11.43 11 62755 1600 79680022
Leukopenia 13.99 11.43 46 62720 116467 79565155
Application site erosion 13.92 11.43 6 62760 280 79681342
Contusion 13.86 11.43 65 62701 148711 79532911
Injection site abscess 13.86 11.43 11 62755 1629 79679993
Brain injury 13.79 11.43 29 62737 11488 79670134
Chills 13.78 11.43 72 62694 160162 79521460
Renal disorder 13.78 11.43 8 62758 42097 79639525
Food craving 13.76 11.43 11 62755 1646 79679976
COVID-19 pneumonia 13.64 11.43 3 62763 28846 79652776
Long QT syndrome congenital 13.63 11.43 5 62761 152 79681470
Hyperthermia 13.62 11.43 38 62728 17999 79663623
Drug abuser 13.56 11.43 20 62746 5993 79675629
Colitis 13.56 11.43 23 62743 73284 79608338
Hepatic failure 13.48 11.43 17 62749 61195 79620427
Foot fracture 13.46 11.43 43 62723 21938 79659684
Hypertonia 13.44 11.43 22 62744 7210 79674412
Red blood cell sedimentation rate increased 13.31 11.43 10 62756 45932 79635690
Diverticulitis 13.31 11.43 10 62756 45926 79635696
Insulin resistance 13.29 11.43 10 62756 1369 79680253
Musculoskeletal pain 13.28 11.43 39 62727 102315 79579307
Shock 13.25 11.43 9 62757 43539 79638083
Muscle spasms 13.22 11.43 202 62564 174528 79507094
Erectile dysfunction 13.21 11.43 33 62733 14631 79666991
Water intoxication 13.21 11.43 8 62758 766 79680856
Injection site erythema 13.15 11.43 26 62740 78171 79603451
Regressive behaviour 13.04 11.43 5 62761 172 79681450
Cytokine release syndrome 13.02 11.43 6 62760 35992 79645630
Device difficult to use 13.00 11.43 31 62735 13354 79668268
Hepatocellular injury 12.99 11.43 11 62755 47582 79634040
Tubulointerstitial nephritis 12.89 11.43 7 62759 38228 79643394
Hip arthroplasty 12.87 11.43 6 62760 35750 79645872
Discomfort 12.84 11.43 53 62713 125564 79556058
Full blood count abnormal 12.81 11.43 8 62758 40466 79641156
Incorrect route of product administration 12.80 11.43 58 62708 34871 79646751
Hyperprolactinaemia 12.70 11.43 17 62749 4659 79676963
Acute respiratory failure 12.63 11.43 17 62749 59524 79622098
Learning disorder 12.58 11.43 7 62759 572 79681050
Sydenham's chorea 12.48 11.43 3 62763 19 79681603
Intracranial pressure increased 12.44 11.43 23 62743 8299 79673323
Libido decreased 12.44 11.43 18 62748 5303 79676319
Neurotoxicity 12.43 11.43 5 62761 32513 79649109
Delusion of parasitosis 12.35 11.43 3 62763 20 79681602
Autophobia 12.35 11.43 3 62763 20 79681602
Dermal absorption impaired 12.35 11.43 3 62763 20 79681602
Erythromelalgia 12.21 11.43 5 62761 205 79681417
Malaise 12.20 11.43 293 62473 489576 79192046
Eosinophilic myocarditis 12.09 11.43 9 62757 1213 79680409
Pressure of speech 12.05 11.43 9 62757 1219 79680403
Haematoma 12.02 11.43 14 62752 52181 79629441
Drug interaction 12.00 11.43 419 62347 414764 79266858
Application site scab 11.97 11.43 5 62761 216 79681406
Libido increased 11.96 11.43 11 62755 1990 79679632
Unresponsive to stimuli 11.91 11.43 80 62686 55708 79625914
Pulmonary mass 11.88 11.43 4 62762 29030 79652592
Psychological abuse 11.87 11.43 3 62763 24 79681598
Perinatal depression 11.86 11.43 6 62760 404 79681218
Osteonecrosis of jaw 11.78 11.43 10 62756 43216 79638406
Device breakage 11.77 11.43 26 62740 10649 79670973
Hepatitis C virus test positive 11.76 11.43 6 62760 411 79681211
Verbigeration 11.76 11.43 3 62763 25 79681597
Haematochezia 11.66 11.43 33 62733 87612 79594010
Excessive masturbation 11.60 11.43 4 62762 101 79681521
Blood pressure increased 11.55 11.43 232 62534 211128 79470494
Cardiac fibrillation 11.55 11.43 8 62758 963 79680659
Schizoaffective disorder bipolar type 11.53 11.43 5 62761 237 79681385
Blood pressure systolic increased 11.50 11.43 22 62744 66964 79614658
Bursitis 11.46 11.43 7 62759 35837 79645785
Sedation 11.43 11.43 75 62691 51820 79629802

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 DISCN 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 DISCN 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 DISCN 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 DISCN 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 DISCN 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 DISCN 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 DISCN 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 DISCN 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 DISCN 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 DISCN 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 DISCN 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 DISCN 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 DISCN 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 DISCN 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 DISCN 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 DISCN 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 DISCN 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 DISCN 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 DISCN 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 DISCN 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 DISCN 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 DISCN 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 DISCN 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 DISCN 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 DISCN 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 DISCN 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 DISCN 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 DISCN 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 DISCN 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 DISCN 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 DISCN 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 DISCN 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 DISCN 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 DISCN 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 DISCN 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 DISCN 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 DISCN 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 DISCN 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 DISCN 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 DISCN 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 DISCN 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 DISCN 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 DISCN CAPSULE, EXTENDED RELEASE ORAL June 28, 2024 LABELING REVISIONS RELATED TO CLINICAL STUDIES
35MG ADHANSIA XR PURDUE PHARMA LP N212038 Feb. 27, 2019 DISCN CAPSULE, EXTENDED RELEASE ORAL June 28, 2024 LABELING REVISIONS RELATED TO CLINICAL STUDIES
45MG ADHANSIA XR PURDUE PHARMA LP N212038 Feb. 27, 2019 DISCN CAPSULE, EXTENDED RELEASE ORAL June 28, 2024 LABELING REVISIONS RELATED TO CLINICAL STUDIES
55MG ADHANSIA XR PURDUE PHARMA LP N212038 Feb. 27, 2019 DISCN CAPSULE, EXTENDED RELEASE ORAL June 28, 2024 LABELING REVISIONS RELATED TO CLINICAL STUDIES
70MG ADHANSIA XR PURDUE PHARMA LP N212038 Feb. 27, 2019 DISCN CAPSULE, EXTENDED RELEASE ORAL June 28, 2024 LABELING REVISIONS RELATED TO CLINICAL STUDIES
85MG ADHANSIA XR PURDUE PHARMA LP N212038 Feb. 27, 2019 DISCN 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
7236 IUPHAR_LIGAND_ID
485 INN_ID
207ZZ9QZ49 UNII
203188 RXNORM
1038 MMSL
253246 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 0078-0370 CAPSULE, EXTENDED RELEASE 20 mg ORAL NDA 33 sections
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 0078-0371 CAPSULE, EXTENDED RELEASE 30 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 0078-0372 CAPSULE, EXTENDED RELEASE 40 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 LA HUMAN PRESCRIPTION DRUG LABEL 1 0078-0424 CAPSULE, EXTENDED RELEASE 10 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 0078-0439 TABLET 5 mg ORAL NDA 30 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 0078-0440 TABLET 10 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
Ritalin HUMAN PRESCRIPTION DRUG LABEL 1 0078-0441 TABLET 20 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 0093-5292 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 0093-5293 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 0093-5295 CAPSULE, EXTENDED RELEASE 10 mg ORAL ANDA 34 sections