methylphenidate 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | 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 µM/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

Predicted pharmacokinetic/toxicological properties (PK-AZ):

PropertyDescriptionValueUnitConfidenceSimilarity
azlogd74 LogD at pH 7.4 0.178 High 1
caco2-efflux Caco-2 efflux ratio (BA/AB) 1.954 High 1
caco2-intrinsic-papp Caco-2 intrinsic apparent permeability 9.376 10^-6 cm/s High 1
dh-clint Dog hepatocyte intrinsic clearance 8.630 uL/min/10^6 cells High 1
dppb Dog plasma protein binding (% unbound) 81.470 % High 1
fcs-ppb Fetal calf serum protein binding (% unbound) 65.690 % High 1
herg hERG pIC50 4.524 pIC50 High 1
hh-clint Human hepatocyte intrinsic clearance 5.420 uL/min/10^6 cells High 1
hlm-clint Human liver microsomal intrinsic clearance 10.765 uL/min/mg protein High 1
hppb Human plasma protein binding (% unbound) 77.700 % High 1
kinase-safety-class ACVR2B,AXL,BRAF,BTK,CAMK2B,CAMK2D,CDK5,CDK9,EIF2AK3,EPHB4,ERBB2,GRK2,ITK,MAP3K7,MAPK7,MET,NTRK2,PDK2,PDK4,PIK3CB,PRKDC,TEK,TGFBR1 23
kinase-selectivity-class AXL,EIF2AK3,GRK2,PDK4 4
mdck-mdr1-efflux MDCK-MDR1 efflux ratio 1.837 High 1
mh-clint Mouse hepatocyte intrinsic clearance 97.724 High 1
mppb Mouse plasma protein binding (% unbound) 78.480 High 1
nih-mdck-mdr1-efflux NIH MDCK-MDR1 efflux ratio 3.133 High 1
pfas-class PFAS structural alert (1 = True, 0 = False) 0
pppb Pig plasma protein binding (% unbound) 82.120 % High 1
rh-clint Rat hepatocyte intrinsic clearance 84.333 uL/min/10^6 cells High 1
rh-fuinc Rat hepatocyte fraction unbound in incubation 91.950 % High 1
rppb Rat plasma protein binding (% unbound) 78.640 % High 1
solubility-dd Solubility at pH 7.4 in DMSO 851.138 uM High 1

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 624.81 11.27 439 52408 73416 90502184
Anxiety 315.98 11.27 611 52236 309161 90266439
Agitation 300.90 11.27 275 52572 66823 90508777
Intentional overdose 274.35 11.27 305 52542 93529 90482071
Aggression 274.15 11.27 179 52668 26489 90549111
Product substitution issue 270.26 11.27 154 52693 17854 90557746
Drug abuse 258.70 11.27 278 52569 82069 90493531
Intentional self-injury 251.62 11.27 176 52671 29158 90546442
Disturbance in attention 246.97 11.27 211 52636 46898 90528702
Tachycardia 218.55 11.27 356 52491 157317 90418283
Abnormal behaviour 204.00 11.27 140 52707 22488 90553112
Depression 200.38 11.27 500 52347 300101 90275499
Product administration interrupted 187.90 11.27 107 52740 12385 90563215
Suicide attempt 185.00 11.27 224 52623 75175 90500425
Attention deficit hyperactivity disorder 184.41 11.27 75 52772 4109 90571491
Toxicity to various agents 177.51 11.27 465 52382 287381 90288219
Somnolence 165.49 11.27 372 52475 208712 90366888
Irritability 165.37 11.27 149 52698 35513 90540087
Pre-existing condition improved 163.89 11.27 88 52759 9081 90566519
Glossodynia 154.70 11.27 8 52839 321771 90253829
Joint swelling 146.93 11.27 55 52792 503245 90072355
Tic 145.14 11.27 51 52796 1860 90573740
Cataplexy 140.53 11.27 47 52800 1473 90574127
Tremor 140.05 11.27 289 52558 152884 90422716
Systemic lupus erythematosus 139.63 11.27 22 52825 361874 90213726
Product quality issue 139.31 11.27 200 52647 79125 90496475
Feeling abnormal 136.16 11.27 301 52546 166934 90408666
Pericarditis 135.50 11.27 5 52842 270146 90305454
No adverse event 132.18 11.27 180 52667 67802 90507798
Somnambulism 129.07 11.27 66 52781 6162 90569438
Precocious puberty 127.60 11.27 31 52816 290 90575310
Wrong technique in product usage process 122.09 11.27 178 52669 71393 90504207
Mydriasis 121.60 11.27 87 52760 14925 90560675
Infusion related reaction 119.17 11.27 47 52800 416733 90158867
Arthropathy 117.39 11.27 34 52813 366208 90209392
Pulmonary malformation 116.70 11.27 30 52817 360 90575240
Psychomotor hyperactivity 112.48 11.27 78 52769 12735 90562865
Panic attack 110.27 11.27 104 52743 26261 90549339
Contraindicated product administered 109.67 11.27 26 52821 320113 90255487
Lower respiratory tract infection 109.52 11.27 10 52837 250649 90324951
Swelling 109.18 11.27 54 52793 419004 90156596
Withdrawal syndrome 108.16 11.27 96 52751 22428 90553172
Psychotic disorder 107.93 11.27 111 52736 31119 90544481
Wound 107.00 11.27 23 52824 302957 90272643
Paranoia 105.00 11.27 75 52772 12833 90562767
Application site erythema 104.48 11.27 54 52793 5154 90570446
Enuresis 103.61 11.27 47 52800 3367 90572233
Folliculitis 101.71 11.27 4 52843 204349 90371251
Hallucination, auditory 101.39 11.27 80 52767 15895 90559705
Intentional product misuse 98.79 11.27 183 52664 89421 90486179
Dissociation 96.92 11.27 56 52791 6659 90568941
Therapeutic response unexpected 96.69 11.27 89 52758 21791 90553809
Blister 94.99 11.27 17 52830 254981 90320619
General physical health deterioration 93.63 11.27 45 52802 355070 90220530
Reversible cerebral vasoconstriction syndrome 92.11 11.27 46 52801 4084 90571516
Overdose 90.22 11.27 248 52599 157461 90418139
Dystonia 89.47 11.27 76 52771 16743 90558857
Completed suicide 87.89 11.27 233 52614 144825 90430775
Sleep apnoea syndrome 87.25 11.27 100 52747 31647 90543953
Muscle injury 86.11 11.27 4 52843 176650 90398950
Delusion of parasitosis 85.60 11.27 19 52828 114 90575486
Drug dependence 85.06 11.27 95 52752 29232 90546368
Pre-eclampsia 84.86 11.27 62 52785 10986 90564614
Impaired healing 84.28 11.27 17 52830 234182 90341418
Educational problem 83.22 11.27 25 52822 548 90575052
Histiocytosis 82.40 11.27 15 52832 24 90575576
Hepatic enzyme increased 80.47 11.27 56 52791 360680 90214920
Dyskinesia 79.11 11.27 102 52745 36432 90539168
Hallucination 78.15 11.27 139 52708 65820 90509780
Peripheral swelling 77.47 11.27 76 52771 413030 90162570
Obsessive-compulsive disorder 77.07 11.27 42 52805 4462 90571138
Type 2 diabetes mellitus 74.72 11.27 14 52833 203230 90372370
Lung cyst 74.53 11.27 22 52825 453 90575147
Respiratory tract malformation 74.41 11.27 18 52829 165 90575435
Arthralgia 74.40 11.27 221 52626 778301 89797299
Crying 74.25 11.27 83 52764 25562 90550038
Rheumatoid arthritis 72.37 11.27 63 52784 362551 90213049
Mobility decreased 72.06 11.27 28 52819 250706 90324894
Product administered at inappropriate site 71.84 11.27 39 52808 4112 90571488
Apathy 71.60 11.27 56 52791 10984 90564616
Treatment failure 70.71 11.27 45 52802 303883 90271717
Bruxism 70.02 11.27 39 52808 4324 90571276
Diarrhoea 69.52 11.27 297 52550 938893 89636707
Application site irritation 69.17 11.27 30 52817 1931 90573669
Surgery 68.49 11.27 106 52741 44781 90530819
Serotonin syndrome 67.18 11.27 96 52751 37791 90537809
Joint range of motion decreased 66.33 11.27 3 52844 135640 90439960
Abdominal discomfort 65.56 11.27 111 52736 477217 90098383
Heart rate increased 65.00 11.27 178 52669 112724 90462876
Psoriatic arthropathy 64.79 11.27 26 52821 228309 90347291
Acute kidney injury 64.73 11.27 55 52792 320332 90255268
Drug intolerance 64.35 11.27 101 52746 447490 90128110
Palpitations 63.80 11.27 200 52647 136528 90439072
Infection 62.95 11.27 71 52776 362023 90213577
Product administration error 62.33 11.27 77 52770 26346 90549254
Mood swings 61.65 11.27 68 52779 20634 90554966
Seizure 61.15 11.27 212 52635 152417 90423183
Bursitis 61.00 11.27 4 52843 131650 90443950
Hallucination, visual 60.54 11.27 71 52776 23021 90552579
Social anxiety disorder 60.22 11.27 20 52827 613 90574987
Mania 59.60 11.27 56 52791 14068 90561532
Impulsive behaviour 59.50 11.27 26 52821 1704 90573896
Stomatitis 59.46 11.27 44 52803 274654 90300946
Anger 59.05 11.27 55 52792 13665 90561935
Blood pressure increased 58.53 11.27 249 52598 196968 90378632
Product tampering 57.87 11.27 18 52829 445 90575155
Hypersomnia 57.78 11.27 67 52780 21464 90554136
Chorea 57.63 11.27 27 52820 2083 90573517
Rash 57.47 11.27 254 52593 795846 89779754
Depressed mood 57.14 11.27 104 52743 50118 90525482
Headache 56.43 11.27 758 52089 861988 89713612
Adulterated product 56.40 11.27 17 52830 377 90575223
Ill-defined disorder 55.91 11.27 19 52828 184872 90390728
Product colour issue 55.83 11.27 20 52827 772 90574828
Product dose omission issue 55.11 11.27 324 52523 291363 90284237
Parasomnia 55.03 11.27 19 52828 657 90574943
Sleep-related eating disorder 54.77 11.27 21 52826 983 90574617
C-reactive protein increased 54.22 11.27 19 52828 181370 90394230
Snoring 54.11 11.27 35 52812 5091 90570509
Restlessness 54.00 11.27 84 52763 35636 90539964
Insomnia 53.99 11.27 356 52491 333118 90242482
C-reactive protein abnormal 53.25 11.27 6 52841 127423 90448177
Alopecia 52.84 11.27 133 52714 494938 90080662
Rapid eye movement sleep behaviour disorder 52.49 11.27 16 52831 369 90575231
Euphoric mood 52.40 11.27 35 52812 5374 90570226
Irritable bowel syndrome 52.08 11.27 28 52819 207420 90368180
Feeling jittery 51.96 11.27 54 52793 15317 90560283
Drug diversion 50.40 11.27 20 52827 1027 90574573
Gastrointestinal disorder 49.51 11.27 46 52801 256641 90318959
Exposure via breast milk 49.33 11.27 25 52822 2290 90573310
Claustrophobia 49.10 11.27 21 52826 1306 90574294
Major depression 48.63 11.27 43 52804 9992 90565608
Bipolar disorder 48.60 11.27 41 52806 8944 90566656
Maternal exposure during breast feeding 47.98 11.27 35 52812 6185 90569415
Sedation 47.67 11.27 94 52753 48077 90527523
Substance abuse 47.66 11.27 33 52814 5373 90570227
Maternal exposure during pregnancy 47.34 11.27 86 52761 359977 90215623
Loss of consciousness 47.09 11.27 184 52663 140054 90435546
Product availability issue 46.81 11.27 37 52810 7367 90568233
Adhesive tape use 46.56 11.27 8 52839 7 90575593
Emotional disorder 45.94 11.27 50 52797 14947 90560653
Lactation disorder 45.82 11.27 15 52832 439 90575161
Pulmonary fibrosis 45.08 11.27 5 52842 107498 90468102
Application site pruritus 44.84 11.27 29 52818 4218 90571382
Hangover 44.78 11.27 23 52824 2166 90573434
Lip dry 44.14 11.27 4 52843 100951 90474649
Drug interaction 44.04 11.27 294 52553 276159 90299441
Perinatal depression 43.42 11.27 17 52830 842 90574758
Febrile neutropenia 43.35 11.27 19 52828 158330 90417270
Growth retardation 43.16 11.27 21 52826 1762 90573838
Narcolepsy 43.07 11.27 20 52827 1512 90574088
Amenorrhoea 42.93 11.27 43 52804 11679 90563921
Musculoskeletal stiffness 42.50 11.27 67 52780 296465 90279135
Muscle twitching 42.43 11.27 61 52786 24141 90551459
Drug hypersensitivity 41.77 11.27 135 52712 463474 90112126
Tardive dyskinesia 41.70 11.27 41 52806 10889 90564711
Hyperreflexia 41.52 11.27 33 52814 6624 90568976
Liver injury 41.39 11.27 24 52823 170543 90405057
Multiple sclerosis relapse 41.22 11.27 93 52754 52212 90523388
Hyperhidrosis 41.12 11.27 173 52674 136132 90439468
Affective disorder 41.01 11.27 35 52812 7758 90567842
Mental disorder 40.73 11.27 70 52777 32248 90543352
Application site urticaria 40.61 11.27 12 52835 248 90575352
Vision blurred 40.57 11.27 149 52698 110144 90465456
Cardiac valve disease 40.17 11.27 28 52819 4607 90570993
Illness 40.17 11.27 122 52725 81847 90493753
Pyrexia 39.99 11.27 224 52623 660261 89915339
Pneumonia 39.94 11.27 214 52633 637845 89937755
Muscle contracture 39.78 11.27 20 52827 1801 90573799
Negative thoughts 39.40 11.27 17 52830 1080 90574520
Discomfort 39.29 11.27 62 52785 274273 90301327
Sleep paralysis 39.24 11.27 16 52831 882 90574718
Anaemia 39.01 11.27 93 52754 352709 90222891
Thrombocytopenia 38.39 11.27 39 52808 208686 90366914
Poor sucking reflex 38.14 11.27 13 52834 432 90575168
Stress 37.89 11.27 119 52728 81276 90494324
Application site rash 37.83 11.27 22 52825 2647 90572953
Osteoarthritis 37.82 11.27 35 52812 195695 90379905
Livedo reticularis 37.46 11.27 24 52823 3435 90572165
Pulse abnormal 37.46 11.27 23 52824 3056 90572544
Hyperventilation 37.01 11.27 31 52816 6697 90568903
Self-destructive behaviour 36.89 11.27 13 52834 478 90575122
Inflammation 36.86 11.27 30 52817 178562 90397038
Splenic infarction 36.85 11.27 20 52827 2107 90573493
Burnout syndrome 36.62 11.27 11 52836 241 90575359
Post-traumatic stress disorder 36.61 11.27 31 52816 6797 90568803
Misophonia 36.26 11.27 6 52841 3 90575597
Drug withdrawal syndrome 35.91 11.27 62 52785 28661 90546939
Wound infection 35.70 11.27 9 52838 106393 90469207
Screaming 35.69 11.27 24 52823 3726 90571874
Restless legs syndrome 35.59 11.27 54 52793 22416 90553184
Somatic symptom disorder 35.11 11.27 23 52824 3418 90572182
Lung disorder 35.09 11.27 22 52825 149861 90425739
Neutropenia 34.97 11.27 48 52799 224856 90350744
Hypersensitivity 34.61 11.27 142 52705 454535 90121065
Dyspnoea 34.51 11.27 338 52509 880617 89694983
Mood altered 34.22 11.27 46 52801 17098 90558502
Nightmare 34.12 11.27 52 52795 21673 90553927
Delusion 33.72 11.27 41 52806 13799 90561801
Trichotillomania 33.54 11.27 9 52838 129 90575471
Hypercholesterolaemia 32.96 11.27 9 52838 100883 90474717
Abnormal sleep-related event 32.94 11.27 14 52833 857 90574743
Blood cholesterol increased 32.73 11.27 44 52803 207968 90367632
Peripheral venous disease 32.55 11.27 5 52842 83916 90491684
Acne 32.38 11.27 59 52788 28448 90547152
Live birth 32.37 11.27 4 52843 79103 90496497
Logorrhoea 32.23 11.27 20 52827 2707 90572893
Oedema 31.89 11.27 42 52805 200253 90375347
Liver disorder 30.97 11.27 16 52831 121253 90454347
Weight decreased 30.85 11.27 348 52499 379562 90196038
Hepatic adenoma 30.62 11.27 11 52836 428 90575172
Musculoskeletal pain 30.36 11.27 33 52814 171218 90404382
Open angle glaucoma 30.31 11.27 10 52837 300 90575300
Death 30.30 11.27 150 52697 456401 90119199
Knee arthroplasty 29.98 11.27 6 52841 83176 90492424
Hyperprolactinaemia 29.82 11.27 25 52822 5408 90570192
Red blood cell sedimentation rate increased 29.68 11.27 6 52841 82589 90493011
Hunger 29.58 11.27 27 52820 6536 90569064
Tachyphrenia 29.44 11.27 16 52831 1690 90573910
Pancytopenia 29.06 11.27 17 52830 120246 90455354
Lower limb fracture 28.89 11.27 7 52840 85006 90490594
Cyanosis 28.36 11.27 45 52802 19410 90556190
Foot fracture 27.64 11.27 53 52794 26553 90549047
Antidepressant discontinuation syndrome 27.37 11.27 8 52839 159 90575441
Nervousness 27.33 11.27 61 52786 33995 90541605
Solar urticaria 27.31 11.27 7 52840 83 90575517
Hyperphagia 26.73 11.27 18 52829 2800 90572800
Neurological symptom 26.71 11.27 26 52821 6821 90568779
Multiple organ dysfunction syndrome 26.67 11.27 4 52843 68332 90507268
Product taste abnormal 26.47 11.27 17 52830 2443 90573157
Treatment noncompliance 26.29 11.27 78 52769 51649 90523951
Memory impairment 26.29 11.27 201 52646 197043 90378557
Body temperature increased 26.22 11.27 71 52776 44639 90530961
Thyroid atrophy 26.18 11.27 9 52838 307 90575293
Brain injury 25.82 11.27 27 52820 7711 90567889
Haemoglobin decreased 25.74 11.27 34 52813 161922 90413678
Petit mal epilepsy 25.54 11.27 22 52825 4936 90570664
Drug screen negative 25.49 11.27 9 52838 333 90575267
Akathisia 25.49 11.27 32 52815 11127 90564473
Cholestasis of pregnancy 25.04 11.27 14 52833 1563 90574037
Chronic fatigue syndrome 25.03 11.27 14 52833 1565 90574035
Anti-transglutaminase antibody increased 24.84 11.27 5 52842 17 90575583
Therapeutic response changed 24.55 11.27 13 52834 1304 90574296
Cardiac failure 24.37 11.27 17 52830 109479 90466121
Borderline personality disorder 24.25 11.27 12 52835 1044 90574556
Formication 24.16 11.27 21 52826 4770 90570830
Trismus 24.04 11.27 21 52826 4800 90570800
Meningitis streptococcal 24.00 11.27 7 52840 138 90575462
Substance-induced psychotic disorder 23.86 11.27 17 52830 2895 90572705
Wheezing 23.80 11.27 66 52781 238014 90337586
Sepsis 23.56 11.27 43 52804 179771 90395829
Liver function test increased 23.51 11.27 10 52837 84845 90490755
Injury 23.44 11.27 50 52797 197299 90378301
Initial insomnia 23.37 11.27 28 52819 9282 90566318
CSWS syndrome 23.30 11.27 5 52842 25 90575575
Hallucination, tactile 23.24 11.27 9 52838 433 90575167
Optic disc haemorrhage 23.23 11.27 7 52840 155 90575445
Mechanical ventilation 23.11 11.27 13 52834 1469 90574131
Paraesthesia ear 22.94 11.27 9 52838 448 90575152
Interstitial lung disease 22.83 11.27 8 52839 76397 90499203
Wound infection fungal 22.82 11.27 7 52840 165 90575435
Extrapyramidal disorder 22.79 11.27 37 52810 16266 90559334
Hyperkalaemia 22.77 11.27 5 52842 64959 90510641
Drug abuser 22.73 11.27 16 52831 2674 90572926
Axonal neuropathy 22.72 11.27 12 52835 1197 90574403
Heavy menstrual bleeding 22.70 11.27 42 52805 20488 90555112
Thinking abnormal 22.69 11.27 31 52816 11701 90563899
Terminal insomnia 22.66 11.27 12 52835 1203 90574397
Galactorrhoea 22.60 11.27 20 52827 4652 90570948
Drug use disorder 22.45 11.27 26 52821 8317 90567283
Application site pain 22.42 11.27 20 52827 4700 90570900
Psychiatric symptom 22.27 11.27 24 52823 7094 90568506
Product prescribing error 21.99 11.27 52 52795 30093 90545507
Nystagmus 21.97 11.27 24 52823 7203 90568397
Autism spectrum disorder 21.96 11.27 12 52835 1281 90574319
Pica 21.74 11.27 5 52842 36 90575564
Intentional dose omission 21.73 11.27 38 52809 17745 90557855
Septic shock 21.64 11.27 11 52836 84149 90491451
Amphetamines positive 21.25 11.27 7 52840 209 90575391
Protrusion tongue 21.23 11.27 8 52839 357 90575243
Hip arthroplasty 21.08 11.27 9 52838 76199 90499401
Dermatitis atopic 21.08 11.27 44 52803 23428 90552172
Pruritus 21.05 11.27 208 52639 541317 90034283
Therapeutic product effect incomplete 20.71 11.27 52 52795 193844 90381756
Pelvic inflammatory disease 20.57 11.27 13 52834 1817 90573783
Poisoning 20.55 11.27 34 52813 15183 90560417
Panic reaction 20.47 11.27 19 52828 4698 90570902
Tachypnoea 20.38 11.27 41 52806 21268 90554332
Uterine haemorrhage 20.35 11.27 19 52828 4733 90570867
Postural orthostatic tachycardia syndrome 20.34 11.27 14 52833 2258 90573342
Hypnagogic hallucination 20.33 11.27 7 52840 240 90575360
Intrusive thoughts 20.06 11.27 8 52839 416 90575184
Orthodontic procedure 20.01 11.27 4 52843 13 90575587
Electrocardiogram QRS complex prolonged 19.94 11.27 23 52824 7325 90568275
Cardiac failure congestive 19.84 11.27 17 52830 98677 90476923
Pain 19.73 11.27 437 52410 995904 89579696
Food craving 19.71 11.27 13 52834 1954 90573646
Application site discolouration 19.61 11.27 10 52837 928 90574672
Exposure during pregnancy 19.61 11.27 219 52628 238191 90337409
Endotracheal intubation 19.55 11.27 16 52831 3348 90572252
Therapy non-responder 19.46 11.27 31 52816 136673 90438927
Eosinophilic myocarditis 19.43 11.27 9 52838 676 90574924
Substance use disorder 19.40 11.27 13 52834 2007 90573593
Product complaint 19.37 11.27 31 52816 13469 90562131
Compulsive lip biting 19.34 11.27 3 52844 0 90575600
Social avoidant behaviour 19.34 11.27 16 52831 3397 90572203
High density lipoprotein increased 19.20 11.27 11 52836 1287 90574313
Gastric bypass 19.20 11.27 13 52834 2041 90573559
Mucosal inflammation 19.08 11.27 5 52842 57620 90517980
Libido decreased 19.06 11.27 15 52832 2967 90572633
Dyslalia 19.03 11.27 9 52838 709 90574891
Muscle discomfort 18.98 11.27 7 52840 294 90575306
Sensory level abnormal 18.93 11.27 6 52841 158 90575442
Gastrointestinal haemorrhage 18.81 11.27 15 52832 90233 90485367
Hallucinations, mixed 18.68 11.27 20 52827 5869 90569731
Seizure like phenomena 18.50 11.27 11 52836 1379 90574221
Autoimmune disorder 18.33 11.27 11 52836 76733 90498867
Dizziness 18.22 11.27 461 52386 588823 89986777
Muscle tightness 18.11 11.27 30 52817 13409 90562191
Antiphospholipid syndrome 18.00 11.27 13 52834 2261 90573339
Nephrolithiasis 17.78 11.27 66 52781 49019 90526581
Raynaud's phenomenon 17.71 11.27 10 52837 1138 90574462
Hyperacusis 17.67 11.27 14 52833 2797 90572803
Prescribed underdose 17.57 11.27 11 52836 75008 90500592
Choreoathetosis 17.49 11.27 8 52839 584 90575016
Sciatica 17.46 11.27 20 52827 101362 90474238
Taste disorder 17.46 11.27 7 52840 61539 90514061
Lethargy 17.39 11.27 78 52769 63061 90512539
Grip strength decreased 17.35 11.27 17 52830 92559 90483041
Learning disorder 17.31 11.27 9 52838 869 90574731
Pleural effusion 17.30 11.27 24 52823 111967 90463633
Bisexuality 17.27 11.27 3 52844 3 90575597
Onychomadesis 17.26 11.27 3 52844 45995 90529605
Hepatotoxicity 17.18 11.27 3 52844 45839 90529761
Migraine 17.09 11.27 178 52669 190214 90385386
Psoriasis 17.07 11.27 38 52809 147716 90427884
Product administered to patient of inappropriate age 16.91 11.27 17 52830 4636 90570964
Pseudolymphoma 16.90 11.27 8 52839 632 90574968
Renal impairment 16.88 11.27 22 52825 105399 90470201
Platelet count decreased 16.85 11.27 34 52813 136935 90438665
Disease progression 16.72 11.27 42 52805 156573 90419027
Respiratory failure 16.72 11.27 27 52820 118391 90457209
Menstruation irregular 16.66 11.27 22 52825 8038 90567562
Gait inability 16.65 11.27 38 52809 146418 90429182
Concussion 16.65 11.27 26 52821 11065 90564535
Long QT syndrome congenital 16.58 11.27 5 52842 111 90575489
Deafness bilateral 16.39 11.27 11 52836 1702 90573898
Nail disorder 16.30 11.27 7 52840 59060 90516540
Foetal exposure timing unspecified 16.26 11.27 7 52840 442 90575158
Nipple disorder 16.15 11.27 6 52841 257 90575343
Removal of foreign body from eye 16.05 11.27 3 52844 6 90575594
Electrocardiogram QT prolonged 15.99 11.27 84 52763 72372 90503228
Incorrect product administration duration 15.94 11.27 35 52812 19287 90556313
Congenital cystic lung 15.80 11.27 4 52843 45 90575555
Product use issue 15.79 11.27 120 52727 329799 90245801
Pseudoporphyria 15.75 11.27 6 52841 276 90575324
Renal failure 15.71 11.27 33 52814 130974 90444626
Lactic acidosis 15.57 11.27 5 52842 50458 90525142
Grimacing 15.55 11.27 7 52840 492 90575108
Malabsorption 15.40 11.27 17 52830 5161 90570439
Diplopia 15.26 11.27 44 52803 28670 90546930
Hepatic cirrhosis 15.20 11.27 9 52838 63244 90512356
Visual snow syndrome 15.20 11.27 4 52843 53 90575547
Personality change 15.16 11.27 20 52827 7301 90568299
Multiple sclerosis 15.13 11.27 43 52804 27797 90547803
Abnormal dreams 15.00 11.27 25 52822 11232 90564368
Foetal exposure during pregnancy 14.91 11.27 57 52790 42918 90532682
Vitamin B12 deficiency 14.81 11.27 20 52827 7466 90568134
Distractibility 14.80 11.27 7 52840 552 90575048
Contusion 14.72 11.27 86 52761 251130 90324470
Mast cell activation syndrome 14.69 11.27 10 52837 1584 90574016
Menstrual disorder 14.66 11.27 18 52829 6120 90569480
Capillaritis 14.65 11.27 5 52842 167 90575433
Rectal haemorrhage 14.60 11.27 16 52831 82728 90492872
Myoclonic epilepsy 14.50 11.27 10 52837 1617 90573983
Hepatitis 14.44 11.27 12 52835 70727 90504873
Mitral valve prolapse 14.38 11.27 12 52835 2579 90573021
Inappropriate schedule of product administration 14.33 11.27 142 52705 149791 90425809
Clumsiness 14.31 11.27 12 52835 2595 90573005
Therapeutic product effect decreased 14.23 11.27 99 52748 277472 90298128
Increased appetite 14.19 11.27 25 52822 11740 90563860
Affect lability 14.10 11.27 32 52815 18031 90557569
Hypersexuality 14.04 11.27 7 52840 619 90574981
Urinary incontinence 14.01 11.27 51 52796 37515 90538085
Schizoaffective disorder bipolar type 13.98 11.27 5 52842 192 90575408
Sensory disturbance 13.96 11.27 29 52818 15384 90560216
Consciousness fluctuating 13.95 11.27 8 52839 938 90574662
Phobia 13.89 11.27 6 52841 382 90575218
Bezoar 13.82 11.27 12 52835 2722 90572878
Intervertebral disc protrusion 13.81 11.27 41 52806 27155 90548445
Product adhesion issue 13.79 11.27 16 52831 5126 90570474
Nephrogenic diabetes insipidus 13.76 11.27 8 52839 962 90574638
Impulse-control disorder 13.67 11.27 8 52839 974 90574626
Vasospasm 13.62 11.27 8 52839 981 90574619
Balance disorder 13.53 11.27 100 52747 96980 90478620
Therapeutic product effect prolonged 13.52 11.27 6 52841 408 90575192
Mental impairment 13.47 11.27 30 52817 16690 90558910
Cardiac arrest 13.45 11.27 106 52741 104829 90470771
Hypocalcaemia 13.43 11.27 4 52843 42364 90533236
Behaviour disorder 13.41 11.27 15 52832 4620 90570980
Neurodegenerative disorder 13.41 11.27 6 52841 416 90575184
Temporomandibular joint syndrome 13.37 11.27 14 52833 4003 90571597
Brain death 13.36 11.27 14 52833 4007 90571593
Victim of sexual abuse 13.35 11.27 7 52840 688 90574912
Upper respiratory tract infection 13.25 11.27 35 52812 128283 90447317
Blepharospasm 13.16 11.27 8 52839 55437 90520163
Macular degeneration 13.15 11.27 3 52844 37967 90537633
Lupus-like syndrome 13.14 11.27 6 52841 48840 90526760
Obesity 13.14 11.27 26 52821 105481 90470119
Ovarian cyst ruptured 13.12 11.27 9 52838 1443 90574157
Drug effect less than expected 13.07 11.27 17 52830 6121 90569479
Neutrophil percentage increased 12.85 11.27 12 52835 2991 90572609
Organic brain syndrome 12.82 11.27 5 52842 245 90575355
White blood cell count decreased 12.81 11.27 52 52795 167057 90408543
Malignant neoplasm progression 12.75 11.27 27 52820 106843 90468757
Rash maculo-papular 12.73 11.27 4 52843 40929 90534671
Osteoporosis 12.71 11.27 23 52824 96508 90479092
Impaired gastric emptying 12.67 11.27 25 52822 12784 90562816
Gastric banding 12.63 11.27 4 52843 105 90575495
Intraocular pressure increased 12.61 11.27 18 52829 7075 90568525
Third stage postpartum haemorrhage 12.55 11.27 3 52844 26 90575574
Alcohol abuse 12.51 11.27 10 52837 2023 90573577
Fibromyalgia 12.41 11.27 70 52777 206199 90369401
Leukopenia 12.39 11.27 25 52822 100685 90474915
Serum serotonin decreased 12.35 11.27 3 52844 28 90575572
Drug screen positive 12.34 11.27 13 52834 3744 90571856
Horner's syndrome 12.26 11.27 3 52844 29 90575571
Blood sodium increased 12.26 11.27 12 52835 3170 90572430
Ideas of reference 12.25 11.27 4 52843 116 90575484
Dependence 12.25 11.27 10 52837 2085 90573515
Device breakage 12.23 11.27 26 52821 14018 90561582
Substance use 12.20 11.27 8 52839 1191 90574409
Urticaria 12.18 11.27 120 52727 312614 90262986
Status epilepticus 12.11 11.27 31 52816 18843 90556757
External ear cellulitis 12.09 11.27 5 52842 286 90575314
Impaired driving ability 12.08 11.27 15 52832 5158 90570442
Hyponatraemia 11.92 11.27 39 52808 133499 90442101
Pulmonary artery stenosis 11.89 11.27 5 52842 298 90575302
Sleep attacks 11.88 11.27 4 52843 128 90575472
Generalised anxiety disorder 11.80 11.27 11 52836 2736 90572864
Orthosis user 11.79 11.27 4 52843 131 90575469
Alcohol use 11.77 11.27 9 52838 1708 90573892
Intracranial pressure increased 11.69 11.27 17 52830 6794 90568806
Prehypertension 11.67 11.27 3 52844 36 90575564
Pollakiuria 11.64 11.27 44 52803 32961 90542639
Sinusitis 11.61 11.27 136 52711 342952 90232648
Radius fracture 11.55 11.27 13 52834 4031 90571569
Poisoning deliberate 11.55 11.27 28 52819 16458 90559142
Ligament sprain 11.55 11.27 26 52821 14573 90561027
Hyperaldosteronism 11.48 11.27 5 52842 325 90575275
Suicidal behaviour 11.47 11.27 11 52836 2833 90572767
Feeling drunk 11.44 11.27 14 52833 4744 90570856
Electroencephalogram abnormal 11.42 11.27 13 52834 4083 90571517
Rash pruritic 11.36 11.27 19 52828 82195 90493405
Oedema peripheral 11.33 11.27 96 52751 257819 90317781

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
Aggression 912.43 12.93 595 49381 43568 42527791
Product quality issue 906.77 12.93 435 49541 17447 42553912
Tic 589.60 12.93 184 49792 2199 42569160
Agitation 534.48 12.93 506 49470 63808 42507551
Abnormal behaviour 525.39 12.93 348 49628 26103 42545256
Suicidal ideation 521.29 12.93 440 49536 47721 42523638
No adverse event 499.12 12.93 393 49583 38628 42532731
Irritability 422.84 12.93 312 49664 27816 42543543
Product substitution issue 420.45 12.93 223 49753 11067 42560292
Psychomotor hyperactivity 367.72 12.93 202 49774 10756 42560603
Dystonia 328.26 12.93 198 49778 12592 42558767
Application site erythema 314.43 12.93 117 49859 2449 42568910
Wrong technique in product usage process 299.04 12.93 306 49670 42329 42529030
Drug dependence 298.61 12.93 258 49718 28836 42542523
Drug abuse 295.55 12.93 478 49498 104293 42467066
Anxiety 293.30 12.93 510 49466 118050 42453309
Dyskinesia 289.03 12.93 239 49737 25151 42546208
Attention deficit hyperactivity disorder 261.76 12.93 108 49868 3000 42568359
Disturbance in attention 259.31 12.93 241 49735 29625 42541734
Insomnia 250.90 12.93 476 49500 117777 42453582
Suicide attempt 238.41 12.93 282 49694 45818 42525541
Acute kidney injury 236.68 12.93 69 49907 367268 42204091
Psychotic disorder 233.17 12.93 225 49751 28983 42542376
Growth retardation 220.15 12.93 89 49887 2343 42569016
Crying 206.61 12.93 115 49861 6279 42565080
Intentional overdose 198.39 12.93 272 49704 51184 42520175
Product administration error 194.95 12.93 166 49810 18177 42553182
Withdrawal syndrome 189.12 12.93 149 49827 14626 42556733
Overdose 185.15 12.93 392 49584 104872 42466487
Depression 183.62 12.93 404 49572 110959 42460400
Pneumonia 180.73 12.93 139 49837 422010 42149349
Product administered at inappropriate site 180.39 12.93 83 49893 3015 42568344
Anger 179.05 12.93 137 49839 12881 42558478
Choreoathetosis 178.94 12.93 62 49914 1047 42570312
Application site irritation 174.11 12.93 55 49921 685 42570674
Toxicity to various agents 166.69 12.93 618 49358 228518 42342841
Application site pruritus 161.14 12.93 63 49913 1515 42569844
Death 158.87 12.93 192 49784 470993 42100366
Intentional product misuse 153.74 12.93 267 49709 61633 42509726
Tachycardia 151.31 12.93 353 49623 100734 42470625
Hallucination, visual 151.16 12.93 153 49823 20867 42550492
Intentional self-injury 148.24 12.93 131 49845 15071 42556288
Anaemia 146.47 12.93 73 49903 280205 42291154
Incorrect product administration duration 143.06 12.93 88 49888 5792 42565567
Impulsive behaviour 141.29 12.93 65 49911 2360 42568999
Depressed mood 137.61 12.93 153 49823 23231 42548128
Trichotillomania 134.30 12.93 29 49947 60 42571299
Diarrhoea 130.16 12.93 213 49763 460636 42110723
Hallucination 129.88 12.93 238 49738 57269 42514090
Coronary artery dissection 124.57 12.93 35 49941 281 42571078
Educational problem 123.81 12.93 40 49936 538 42570821
Paranoia 123.26 12.93 114 49862 13912 42557447
Disturbance in social behaviour 123.12 12.93 54 49922 1749 42569610
Hyperkinesia 118.38 12.93 55 49921 2043 42569316
Drug diversion 113.62 12.93 43 49933 944 42570415
Affect lability 112.57 12.93 66 49910 3978 42567381
Product adhesion issue 112.04 12.93 50 49926 1689 42569670
Sepsis 108.52 12.93 49 49927 199285 42372074
Serotonin syndrome 106.21 12.93 141 49835 25704 42545655
Dyspnoea 105.98 12.93 226 49750 442395 42128964
Trismus 104.60 12.93 56 49920 2828 42568531
Somnolence 103.56 12.93 382 49594 140723 42430636
Mydriasis 102.76 12.93 84 49892 8686 42562673
Oromandibular dystonia 101.56 12.93 35 49941 581 42570778
Priapism 100.55 12.93 73 49903 6334 42565025
Oppositional defiant disorder 100.16 12.93 34 49942 538 42570821
Febrile neutropenia 98.98 12.93 47 49929 185656 42385703
Palpitations 97.20 12.93 196 49780 50601 42520758
Homicidal ideation 95.06 12.93 52 49924 2742 42568617
Emotional disorder 94.70 12.93 70 49906 6244 42565115
Hallucination, auditory 93.96 12.93 101 49875 14763 42556596
Mania 93.20 12.93 86 49890 10461 42560898
General physical health deterioration 92.49 12.93 31 49945 151215 42420144
Hypotension 91.94 12.93 100 49876 257531 42313828
Bruxism 86.86 12.93 45 49931 2124 42569235
Drug ineffective 85.77 12.93 1119 48857 629078 41942281
Feeling abnormal 84.62 12.93 225 49751 69561 42501798
Product complaint 84.60 12.93 64 49912 5913 42565446
Poisoning 84.45 12.93 95 49881 14604 42556755
Substance abuse 83.36 12.93 75 49901 8830 42562529
Restlessness 83.01 12.93 134 49842 29115 42542244
Therapeutic product effect decreased 82.09 12.93 157 49819 38993 42532366
Thrombocytopenia 81.98 12.93 62 49914 190217 42381142
Logorrhoea 81.28 12.93 47 49929 2760 42568599
Neutropenia 80.90 12.93 69 49907 199362 42371997
Pyrexia 80.13 12.93 219 49757 393823 42177536
Enuresis 79.54 12.93 46 49930 2702 42568657
Drug use disorder 79.41 12.93 78 49898 10255 42561104
Decreased appetite 79.17 12.93 440 49536 192697 42378662
Mood altered 78.84 12.93 79 49897 10639 42560720
Gastrointestinal haemorrhage 77.92 12.93 11 49965 97715 42473644
Multiple organ dysfunction syndrome 77.19 12.93 11 49965 97024 42474335
Renal impairment 75.89 12.93 18 49958 110210 42461149
Decreased eye contact 75.81 12.93 27 49949 496 42570863
Precocious puberty 75.80 12.93 20 49956 123 42571236
Product prescribing error 74.61 12.93 120 49856 25992 42545367
Interstitial lung disease 72.52 12.93 5 49971 78457 42492902
Application site rash 71.43 12.93 31 49945 978 42570381
Kounis syndrome 70.90 12.93 46 49930 3322 42568037
Delusion 69.35 12.93 86 49890 14648 42556711
Hallucination, tactile 69.07 12.93 26 49950 562 42570797
Renal failure 68.33 12.93 42 49934 143684 42427675
Sleep disorder 65.45 12.93 162 49814 47933 42523426
Gynaecomastia 65.10 12.93 77 49899 12490 42558869
Suicidal behaviour 64.58 12.93 33 49943 1513 42569846
Autism spectrum disorder 63.37 12.93 41 49935 2947 42568412
Platelet count decreased 62.47 12.93 43 49933 138538 42432821
Torticollis 62.38 12.93 31 49945 1339 42570020
Apathy 60.07 12.93 61 49915 8345 42563014
Euphoric mood 59.71 12.93 54 49922 6399 42564960
Headache 59.18 12.93 481 49495 238888 42332471
Haemoglobin decreased 58.53 12.93 42 49934 132429 42438930
Disease progression 57.86 12.93 50 49926 143606 42427753
Panic attack 57.75 12.93 68 49908 10977 42560382
Drug tolerance 57.42 12.93 40 49936 3250 42568109
Completed suicide 56.87 12.93 244 49732 96221 42475138
Application site urticaria 56.35 12.93 14 49962 65 42571294
Oedema peripheral 55.24 12.93 47 49929 136029 42435330
Pancytopenia 55.14 12.93 35 49941 117708 42453651
Respiratory failure 54.83 12.93 42 49934 128090 42443269
Arteriospasm coronary 54.71 12.93 45 49931 4693 42566666
Dermo-hypodermitis 54.11 12.93 23 49953 689 42570670
Speech disorder 54.06 12.93 111 49865 29010 42542349
Blood creatinine increased 53.88 12.93 31 49945 109972 42461387
Cardiac valve disease 53.63 12.93 39 49937 3392 42567967
Alice in wonderland syndrome 53.45 12.93 10 49966 5 42571354
Extrapyramidal disorder 53.27 12.93 80 49896 16332 42555027
Cardiac failure congestive 53.26 12.93 17 49959 85585 42485774
Mood swings 52.34 12.93 58 49918 8768 42562591
Screaming 52.16 12.93 31 49945 1916 42569443
Application site pain 51.97 12.93 33 49943 2296 42569063
Hyperkalaemia 51.82 12.93 15 49961 80443 42490916
Adhesive tape use 51.75 12.93 9 49967 0 42571359
Dermatillomania 51.70 12.93 13 49963 64 42571295
Septic shock 50.66 12.93 22 49954 91650 42479709
Product taste abnormal 50.46 12.93 26 49950 1213 42570146
Obsessive-compulsive disorder 50.14 12.93 50 49926 6693 42564666
Social avoidant behaviour 49.78 12.93 37 49939 3327 42568032
Bipolar disorder 48.98 12.93 39 49937 3883 42567476
Atrial fibrillation 48.82 12.93 55 49921 139538 42431821
White blood cell count decreased 48.76 12.93 35 49941 110361 42460998
Increased appetite 48.51 12.93 56 49920 8850 42562509
Formication 48.26 12.93 30 49946 2011 42569348
Oculogyric crisis 47.01 12.93 28 49948 1737 42569622
Therapeutic response unexpected 46.60 12.93 62 49914 11319 42560040
Drug screen negative 46.41 12.93 15 49961 202 42571157
Sleep apnoea syndrome 45.70 12.93 87 49889 21521 42549838
Distractibility 45.61 12.93 18 49958 444 42570915
Panic reaction 44.93 12.93 27 49949 1703 42569656
Generalised tonic-clonic seizure 44.84 12.93 97 49879 26282 42545077
Hallucinations, mixed 44.71 12.93 35 49941 3400 42567959
Raynaud's phenomenon 43.14 12.93 15 49961 256 42571103
Seizure 43.04 12.93 265 49711 120296 42451063
Keratoconus 42.61 12.93 13 49963 143 42571216
Peripheral swelling 42.02 12.93 27 49949 90243 42481116
Arthralgia 41.64 12.93 114 49862 205124 42366235
Mycobacterial peritonitis 41.29 12.93 13 49963 160 42571199
Hyponatraemia 41.22 12.93 35 49941 101427 42469932
Drug withdrawal syndrome 41.02 12.93 83 49893 21466 42549893
Heart rate increased 40.52 12.93 146 49830 53109 42518250
Mycobacterium fortuitum infection 40.30 12.93 16 49960 401 42570958
Cataplexy 39.93 12.93 16 49960 411 42570948
Mental disorder 39.88 12.93 74 49902 17955 42553404
Joint swelling 39.74 12.93 15 49961 68007 42503352
Thinking abnormal 38.96 12.93 45 49931 7116 42564243
Substance use disorder 38.58 12.93 39 49937 5306 42566053
Product administered to patient of inappropriate age 38.57 12.93 37 49939 4724 42566635
Pain 37.98 12.93 153 49823 244695 42326664
Coordination abnormal 37.90 12.93 47 49929 8003 42563356
Treatment noncompliance 37.36 12.93 113 49863 37559 42533800
Asthenia 37.24 12.93 186 49790 280607 42290752
Product colour issue 36.90 12.93 17 49959 619 42570740
Cough 36.81 12.93 98 49878 178005 42393354
Tardive dyskinesia 36.81 12.93 43 49933 6881 42564478
Malignant neoplasm progression 36.50 12.93 44 49932 108356 42463003
Product use issue 36.25 12.93 182 49794 76569 42494790
Rheumatoid arthritis 35.70 12.93 4 49972 42436 42528923
Product administration interrupted 35.41 12.93 36 49940 4930 42566429
Hypokinesia 34.75 12.93 50 49926 9821 42561538
Ventricular parasystole 34.50 12.93 6 49970 0 42571359
Change in sustained attention 34.47 12.93 7 49969 9 42571350
Somnambulism 34.43 12.93 30 49946 3385 42567974
Pleural effusion 34.27 12.93 38 49938 97128 42474231
Infection 34.14 12.93 49 49927 112019 42459340
Mucosal inflammation 34.09 12.93 8 49968 49366 42521993
Abdominal distension 34.01 12.93 21 49955 71714 42499645
Hypertension 33.98 12.93 322 49654 166882 42404477
Ascites 33.95 12.93 12 49964 56666 42514693
Tremor 33.92 12.93 212 49764 96717 42474642
Obsessive-compulsive symptom 33.71 12.93 12 49964 220 42571139
Dissociation 33.61 12.93 31 49945 3767 42567592
Fear 33.54 12.93 52 49924 10913 42560446
Affective disorder 33.35 12.93 38 49938 5922 42565437
COVID-19 33.10 12.93 53 49923 115895 42455464
Nervousness 33.06 12.93 58 49918 13474 42557885
Infusion related reaction 32.95 12.93 15 49961 60791 42510568
Neutrophil count decreased 32.30 12.93 17 49959 63398 42507961
Pre-existing condition improved 31.84 12.93 27 49949 2936 42568423
Melaena 31.73 12.93 4 49972 38742 42532617
Neuropathy peripheral 31.55 12.93 44 49932 101809 42469550
Cardiac failure 31.30 12.93 48 49928 106808 42464551
Myelosuppression 31.21 12.93 5 49971 40456 42530903
Muscle contracture 31.19 12.93 20 49956 1415 42569944
Cytokine release syndrome 31.17 12.93 7 49969 44520 42526839
Self-injurious ideation 30.95 12.93 22 49954 1846 42569513
Acute psychosis 30.38 12.93 23 49953 2126 42569233
Substance-induced psychotic disorder 30.38 12.93 26 49950 2863 42568496
Peripheral coldness 30.33 12.93 43 49933 8332 42563027
Gilbert's syndrome 30.09 12.93 7 49969 23 42571336
Depersonalisation/derealisation disorder 29.99 12.93 15 49961 657 42570702
Regressive behaviour 29.94 12.93 8 49968 52 42571307
Phobia 29.71 12.93 10 49966 154 42571205
Chronic obstructive pulmonary disease 29.20 12.93 19 49957 63095 42508264
Productive cough 29.08 12.93 12 49964 51555 42519804
Daydreaming 28.95 12.93 15 49961 708 42570651
Product dispensing error 28.82 12.93 40 49936 7599 42563760
Pain in extremity 28.80 12.93 86 49890 150518 42420841
Benign rolandic epilepsy 28.75 12.93 5 49971 0 42571359
Constipation 28.70 12.93 96 49880 162195 42409164
Onychophagia 28.61 12.93 8 49968 63 42571296
Rebound effect 28.39 12.93 39 49937 7340 42564019
Chronic kidney disease 28.30 12.93 10 49966 47231 42524128
Sexually inappropriate behaviour 28.08 12.93 14 49962 609 42570750
Tourette's disorder 27.86 12.93 8 49968 70 42571289
Excessive eye blinking 27.66 12.93 14 49962 629 42570730
Hypokalaemia 27.61 12.93 26 49950 71695 42499664
Erection increased 27.60 12.93 13 49963 498 42570861
Lung disorder 27.27 12.93 11 49965 47912 42523447
Dissociative disorder 27.07 12.93 14 49962 658 42570701
C-reactive protein increased 26.96 12.93 21 49955 63539 42507820
Sudden death 26.96 12.93 60 49916 16569 42554790
Hyperhidrosis 26.85 12.93 190 49786 90322 42481037
Oxygen saturation decreased 26.65 12.93 22 49954 64665 42506694
Delayed puberty 26.36 12.93 10 49966 221 42571138
Personality change 26.30 12.93 33 49943 5686 42565673
Liver disorder 26.25 12.93 7 49969 39637 42531722
Dysphemia 26.11 12.93 20 49956 1882 42569477
Pulmonary embolism 26.10 12.93 64 49912 119548 42451811
Feeling jittery 25.71 12.93 29 49947 4469 42566890
Parasomnia 25.55 12.93 12 49964 457 42570902
Weight increased 25.53 12.93 215 49761 107768 42463591
Cholestasis 25.50 12.93 4 49972 32875 42538484
Multiple cardiac defects 25.39 12.93 7 49969 52 42571307
Incorrect dose administered 25.28 12.93 126 49850 52848 42518511
Weight gain poor 25.18 12.93 17 49959 1312 42570047
Hypocalcaemia 24.99 12.93 3 49973 30170 42541189
Blood creatine phosphokinase increased 24.51 12.93 117 49859 48221 42523138
Sympathomimetic effect 24.38 12.93 5 49971 7 42571352
Prostate cancer 24.20 12.93 11 49965 44632 42526727
Application site erosion 24.15 12.93 8 49968 117 42571242
Stereotypy 24.12 12.93 14 49962 828 42570531
Haemoptysis 24.07 12.93 12 49964 46155 42525204
Pericardial effusion 24.03 12.93 3 49973 29272 42542087
Artery dissection 24.02 12.93 10 49966 284 42571075
Renal disorder 23.71 12.93 3 49973 28977 42542382
Sedation 23.55 12.93 84 49892 30391 42540968
Negativism 23.39 12.93 11 49965 420 42570939
Dyspnoea exertional 23.33 12.93 15 49961 50133 42521226
Blood urea increased 23.26 12.93 5 49971 32788 42538571
Akathisia 23.24 12.93 43 49933 10408 42560951
Therapeutic response changed 23.11 12.93 12 49964 569 42570790
Animal phobia 23.00 12.93 4 49972 0 42571359
Terminal insomnia 22.98 12.93 14 49962 905 42570454
Dehydration 22.96 12.93 87 49889 141680 42429679
Unresponsive to stimuli 22.95 12.93 85 49891 31318 42540041
Product residue present 22.86 12.93 22 49954 2819 42568540
Thrombosis 22.85 12.93 28 49948 68483 42502876
Exposure via direct contact 22.59 12.93 6 49970 38 42571321
Fall 22.39 12.93 172 49804 234348 42337011
Erythema 22.35 12.93 60 49916 108733 42462626
Lumbosacral radiculoplexus neuropathy 22.32 12.93 7 49969 85 42571274
Metabolic acidosis 22.16 12.93 17 49959 51841 42519518
Bradyphrenia 22.06 12.93 29 49947 5233 42566126
Rash 22.04 12.93 213 49763 276741 42294618
Device difficult to use 21.90 12.93 27 49949 4569 42566790
Polydipsia psychogenic 21.83 12.93 8 49968 160 42571199
Hypoxia 21.75 12.93 30 49946 69756 42501603
Urinary tract infection 21.75 12.93 53 49923 99231 42472128
Tongue spasm 21.71 12.93 6 49970 45 42571314
Petit mal epilepsy 21.66 12.93 24 49952 3626 42567733
Amnesia 21.65 12.93 78 49898 28359 42543000
Narcolepsy 21.62 12.93 12 49964 651 42570708
International normalised ratio increased 21.61 12.93 15 49961 48153 42523206
Illusion 21.53 12.93 14 49962 1015 42570344
Pneumonitis 21.52 12.93 11 49965 41707 42529652
Major depression 21.48 12.93 29 49947 5369 42565990
Electrocardiogram QT prolonged 21.45 12.93 112 49864 47833 42523526
Arteriosclerosis coronary artery 21.39 12.93 59 49917 18618 42552741
Initial insomnia 21.38 12.93 25 49951 4005 42567354
Substance abuser 21.16 12.93 9 49967 270 42571089
Plasma cell myeloma 21.10 12.93 15 49961 47563 42523796
Lower respiratory tract infection 21.05 12.93 11 49965 41195 42530164
Hypomagnesaemia 20.92 12.93 4 49972 28484 42542875
Wheezing 20.92 12.93 20 49956 54761 42516598
Physical assault 20.89 12.93 14 49962 1068 42570291
Ataxia 20.55 12.93 53 49923 16072 42555287
Surgery 20.52 12.93 56 49920 17560 42553799
Suspiciousness 20.40 12.93 10 49966 419 42570940
Rectal haemorrhage 20.27 12.93 17 49959 49589 42521770
Coronary artery disease 20.06 12.93 20 49956 53700 42517659
Device breakage 19.97 12.93 23 49953 3626 42567733
Back pain 19.86 12.93 92 49884 141684 42429675
Prescription form tampering 19.75 12.93 11 49965 601 42570758
Testicular failure 19.67 12.93 6 49970 66 42571293
Stomatitis 19.66 12.93 18 49958 50311 42521048
Dysphoria 19.54 12.93 20 49956 2760 42568599
Application site scab 19.51 12.93 6 49970 68 42571291
Hepatic function abnormal 19.49 12.93 19 49957 51548 42519811
Scoliosis 19.33 12.93 21 49955 3105 42568254
School refusal 19.20 12.93 5 49971 29 42571330
Lactic acidosis 19.13 12.93 15 49961 45246 42526113
Pulmonary fibrosis 19.07 12.93 4 49972 26677 42544682
Colitis 18.98 12.93 16 49960 46556 42524803
Persecutory delusion 18.72 12.93 22 49954 3542 42567817
Product availability issue 18.71 12.93 22 49954 3545 42567814
Acute respiratory distress syndrome 18.68 12.93 6 49970 30102 42541257
Wolff-Parkinson-White syndrome 18.50 12.93 8 49968 250 42571109
Tongue biting 18.47 12.93 13 49963 1074 42570285
Self-destructive behaviour 18.39 12.93 9 49967 376 42570983
Accidental exposure to product by child 18.34 12.93 15 49961 1552 42569807
Bone marrow failure 18.18 12.93 8 49968 33085 42538274
Hyperprolactinaemia 18.15 12.93 17 49959 2106 42569253
Brain oedema 18.13 12.93 51 49925 16276 42555083
Sexual dysfunction 17.81 12.93 30 49946 6745 42564614
Shock 17.72 12.93 6 49970 29115 42542244
Application site dryness 17.56 12.93 6 49970 97 42571262
Poor quality sleep 17.53 12.93 36 49940 9404 42561955
Hypervolaemia 17.52 12.93 3 49973 23122 42548237
Regurgitation 17.49 12.93 16 49960 1924 42569435
Hypoglycaemia 17.41 12.93 27 49949 59827 42511532
Pica 17.39 12.93 5 49971 44 42571315
Cerebral congestion 17.33 12.93 6 49970 101 42571258
Libido increased 17.32 12.93 12 49964 966 42570393
Chorea 17.27 12.93 14 49962 1430 42569929
Cerebral arteritis 17.25 12.93 3 49973 0 42571359
Cardiac contusion 17.25 12.93 3 49973 0 42571359
Drug effect faster than expected 17.25 12.93 3 49973 0 42571359
Limb girth decreased 17.25 12.93 3 49973 0 42571359
Nail picking 17.25 12.93 3 49973 0 42571359
Binocular eye movement disorder 17.25 12.93 8 49968 296 42571063
Splenic artery thrombosis 17.23 12.93 4 49972 13 42571346
Eosinophilic pneumonia chronic 17.17 12.93 8 49968 299 42571060
Disseminated intravascular coagulation 17.15 12.93 4 49972 24790 42546569
Myelodysplastic syndrome 17.12 12.93 3 49973 22742 42548617
Congestive cardiomyopathy 16.96 12.93 34 49942 8730 42562629
Drooling 16.96 12.93 23 49953 4276 42567083
Poor quality product administered 16.95 12.93 17 49959 2291 42569068
Substance use 16.89 12.93 15 49961 1736 42569623
Impaired driving ability 16.80 12.93 19 49957 2936 42568423
Sydenham's chorea 16.78 12.93 4 49972 15 42571344
Intrusive thoughts 16.76 12.93 9 49967 457 42570902
Performance status decreased 16.75 12.93 24 49952 4696 42566663
Gout 16.69 12.93 6 49970 28049 42543310
Idiopathic intracranial hypertension 16.65 12.93 11 49965 819 42570540
Therapeutic product effect delayed 16.60 12.93 14 49962 1511 42569848
Application site ulcer 16.58 12.93 4 49972 16 42571343
Reduced facial expression 16.54 12.93 14 49962 1519 42569840
Chills 16.37 12.93 56 49920 94010 42477349
Bipolar I disorder 16.32 12.93 11 49965 847 42570512
Painful erection 16.15 12.93 8 49968 343 42571016
Staring 16.15 12.93 14 49962 1569 42569790
Urinary incontinence 16.13 12.93 59 49917 21609 42549750
Hyperglycaemia 16.09 12.93 18 49958 45841 42525518
Vision blurred 16.07 12.93 113 49863 53586 42517773
Application site discolouration 16.02 12.93 8 49968 349 42571010
Product dose omission issue 15.97 12.93 262 49714 154103 42417256
Neoplasm progression 15.95 12.93 7 49969 28993 42542366
Agranulocytosis 15.89 12.93 8 49968 30604 42540755
Anaphylactic shock 15.86 12.93 4 49972 23513 42547846
Hypomania 15.77 12.93 17 49959 2491 42568868
Defiant behaviour 15.69 12.93 4 49972 21 42571338
Behaviour disorder 15.66 12.93 29 49947 7025 42564334
Tri-iodothyronine increased 15.56 12.93 5 49971 66 42571293
Erectile dysfunction 15.42 12.93 64 49912 24849 42546510
Drug eruption 15.42 12.93 4 49972 23071 42548288
Tubulointerstitial nephritis 15.28 12.93 9 49967 31539 42539820
Hypersexuality 15.27 12.93 14 49962 1688 42569671
Hypophosphataemia 15.26 12.93 3 49973 20942 42550417
Psychopathic personality 15.17 12.93 3 49973 3 42571356
Frustration tolerance decreased 15.17 12.93 19 49957 3267 42568092
Inappropriate affect 15.12 12.93 10 49966 746 42570613
Pressure of speech 15.09 12.93 9 49967 560 42570799
Basal cell carcinoma 15.07 12.93 4 49972 22729 42548630
Haematoma 15.04 12.93 7 49969 28016 42543343
Urine sodium increased 14.97 12.93 5 49971 75 42571284
Arthropathy 14.97 12.93 8 49968 29589 42541770
Hyperacusis 14.93 12.93 11 49965 976 42570383
Red blood cell count decreased 14.92 12.93 10 49966 32705 42538654
Dependence 14.92 12.93 13 49963 1467 42569892
Strabismus 14.91 12.93 16 49960 2332 42569027
Lymphocyte count decreased 14.84 12.93 7 49969 27802 42543557
Vasospasm 14.84 12.93 9 49967 577 42570782
Therapeutic product effect increased 14.75 12.93 10 49966 777 42570582
Oedema 14.61 12.93 24 49952 51977 42519382
Inflammation 14.58 12.93 11 49965 33836 42537523
Eye movement disorder 14.49 12.93 23 49953 4922 42566437
Anorexia nervosa 14.47 12.93 4 49972 30 42571329
Insulin resistance 14.46 12.93 10 49966 803 42570556
Haemorrhage 14.33 12.93 31 49945 60532 42510827
Epiphyses delayed fusion 14.31 12.93 3 49973 5 42571354
Tension 14.28 12.93 16 49960 2448 42568911
Muscle twitching 14.27 12.93 38 49938 11742 42559617
Stubbornness 14.25 12.93 4 49972 32 42571327
Drug reaction with eosinophilia and systemic symptoms 14.23 12.93 17 49959 42058 42529301
Mental impairment 14.19 12.93 39 49937 12278 42559081
Opisthotonus 14.19 12.93 9 49967 625 42570734
Neurotoxicity 14.17 12.93 5 49971 23646 42547713
Treatment failure 14.05 12.93 33 49943 62591 42508768
Encopresis 14.04 12.93 6 49970 182 42571177
Respiratory distress 14.04 12.93 17 49959 41803 42529556
Accommodation disorder 14.01 12.93 7 49969 306 42571053
COVID-19 pneumonia 13.96 12.93 4 49972 21609 42549750
Schizotypal personality disorder 13.96 12.93 3 49973 6 42571353
Dermal absorption impaired 13.96 12.93 3 49973 6 42571353
Rash maculo-papular 13.96 12.93 14 49962 37489 42533870
Deep vein thrombosis 13.95 12.93 45 49931 76912 42494447
Meningitis staphylococcal 13.93 12.93 5 49971 94 42571265
Blood growth hormone decreased 13.93 12.93 4 49972 35 42571324
Swelling 13.92 12.93 27 49949 54858 42516501
Haematochezia 13.76 12.93 30 49946 58406 42512953
Application site laceration 13.65 12.93 3 49973 7 42571352
Obstructive airways disorder 13.58 12.93 6 49970 24753 42546606
Blood pressure systolic increased 13.51 12.93 8 49968 27960 42543399
Hepatitis C RNA 13.45 12.93 4 49972 40 42571319
Streptococcal infection 13.35 12.93 25 49951 6107 42565252
Personality disorder 13.33 12.93 11 49965 1152 42570207
Electrocardiogram T wave inversion 13.26 12.93 15 49961 2319 42569040
Dyssomnia 13.11 12.93 4 49972 44 42571315
Myalgia 13.07 12.93 63 49913 96017 42475342
Dermatitis atopic 13.04 12.93 38 49938 12366 42558993
Coeliac disease 13.01 12.93 10 49966 946 42570413
Palmar-plantar erythrodysaesthesia syndrome 12.95 12.93 4 49972 20578 42550781

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 1035.29 11.33 598 77697 58612 110452392
Suicidal ideation 873.15 11.33 638 77657 93299 110417705
Agitation 795.63 11.33 651 77644 112400 110398604
Abnormal behaviour 623.48 11.33 372 77923 38667 110472337
Product substitution issue 610.62 11.33 307 77988 22754 110488250
Tic 564.54 11.33 173 78122 3320 110507684
Irritability 528.02 11.33 361 77934 47448 110463556
Drug abuse 449.71 11.33 590 77705 176821 110334183
Toxicity to various agents 436.49 11.33 1014 77281 479541 110031463
Intentional overdose 428.19 11.33 498 77797 132003 110379001
Dystonia 412.23 11.33 246 78049 25559 110485445
Psychomotor hyperactivity 386.94 11.33 217 78078 20060 110490944
Anxiety 385.73 11.33 792 77503 344286 110166718
Intentional self-injury 369.75 11.33 264 78031 37165 110473839
Suicide attempt 366.89 11.33 408 77887 102986 110408018
Tachycardia 365.02 11.33 609 77686 226036 110284968
Disturbance in attention 360.09 11.33 320 77975 61675 110449329
Attention deficit hyperactivity disorder 329.89 11.33 123 78172 4368 110506636
Dyskinesia 325.85 11.33 279 78016 51167 110459837
Drug dependence 298.07 11.33 262 78033 49758 110461246
Overdose 278.13 11.33 551 77744 233243 110277761
Psychotic disorder 262.68 11.33 246 78049 50691 110460313
Withdrawal syndrome 261.92 11.33 200 78095 31180 110479824
Product quality issue 243.67 11.33 287 78008 77012 110433992
No adverse event 227.53 11.33 271 78024 73568 110437436
Intentional product misuse 227.08 11.33 367 77928 132537 110378467
Depression 220.91 11.33 606 77689 316729 110194275
Hallucination, visual 213.34 11.33 196 78099 39409 110471595
Educational problem 208.01 11.33 53 78242 495 110510509
Mydriasis 206.74 11.33 151 78144 22006 110488998
Somnolence 205.00 11.33 566 77729 296883 110214121
Insomnia 199.84 11.33 635 77660 359955 110151049
Anger 199.12 11.33 139 78156 18868 110492136
Hallucination 192.53 11.33 294 78001 101138 110409866
Paranoia 192.00 11.33 145 78150 22229 110488775
Acute kidney injury 189.96 11.33 107 78188 635323 109875681
Crying 189.34 11.33 152 78143 25476 110485528
Choreoathetosis 187.65 11.33 63 78232 1635 110509369
Serotonin syndrome 180.42 11.33 216 78079 58937 110452067
Synovitis 178.78 11.33 3 78292 274089 110236915
Application site erythema 173.30 11.33 83 78212 5527 110505477
Completed suicide 167.70 11.33 462 77833 241919 110269085
Joint swelling 166.75 11.33 53 78242 442792 110068212
Hallucination, auditory 160.71 11.33 140 78155 26257 110484747
Growth retardation 158.33 11.33 62 78233 2520 110508484
Precocious puberty 158.21 11.33 40 78255 361 110510643
Impulsive behaviour 153.26 11.33 65 78230 3250 110507754
Wrong technique in product usage process 151.60 11.33 243 78052 87105 110423899
General physical health deterioration 151.29 11.33 56 78239 425239 110085765
Diarrhoea 151.13 11.33 368 77927 1139137 109371867
Mania 150.78 11.33 122 78173 20674 110490330
Tremor 150.45 11.33 396 77899 201836 110309168
Enuresis 140.06 11.33 65 78230 4031 110506973
Hyperkinesia 139.17 11.33 60 78235 3124 110507880
Infusion related reaction 130.89 11.33 53 78242 381109 110129895
Arthropathy 130.62 11.33 23 78272 287499 110223505
Systemic lupus erythematosus 130.48 11.33 14 78281 254324 110256680
Trismus 129.66 11.33 72 78223 6524 110504480
Product administration error 128.71 11.33 145 78150 37072 110473932
Dissociation 127.17 11.33 82 78213 9760 110501244
Substance abuse 125.56 11.33 89 78206 12374 110498630
Pneumonia 125.07 11.33 272 78023 876442 109634562
Depressed mood 124.99 11.33 183 78112 60626 110450378
Peripheral swelling 123.57 11.33 66 78229 403968 110107036
Cardiac valve disease 123.24 11.33 69 78226 6352 110504652
Anaemia 122.54 11.33 124 78171 546962 109964042
Lower respiratory tract infection 120.67 11.33 15 78280 243091 110267913
Trichotillomania 120.04 11.33 28 78267 173 110510831
Cataplexy 119.85 11.33 41 78254 1128 110509876
Priapism 118.02 11.33 65 78230 5796 110505208
Coronary artery dissection 117.23 11.33 41 78254 1207 110509797
Apathy 115.06 11.33 94 78201 16145 110494859
Feeling abnormal 114.71 11.33 334 77961 180377 110330627
Glossodynia 114.44 11.33 12 78283 221992 110289012
Mood altered 111.64 11.33 104 78191 21271 110489733
Panic attack 110.90 11.33 119 78176 28821 110482183
Restlessness 110.87 11.33 166 78129 56093 110454911
Bruxism 110.62 11.33 59 78236 4935 110506069
Pericarditis 107.58 11.33 14 78281 219100 110291904
Homicidal ideation 107.01 11.33 52 78243 3575 110507429
Oppositional defiant disorder 106.92 11.33 31 78264 487 110510517
Product administered at inappropriate site 106.37 11.33 59 78236 5334 110505670
Swelling 106.37 11.33 58 78237 350983 110160021
Palpitations 105.63 11.33 299 77996 158913 110352091
Product administration interrupted 105.43 11.33 77 78218 11215 110499789
Folliculitis 104.75 11.33 3 78292 167650 110343354
Delusion 104.18 11.33 105 78190 23650 110487354
Emotional disorder 100.98 11.33 87 78208 16073 110494931
Muscle contracture 97.38 11.33 45 78250 2763 110508241
Poisoning 96.58 11.33 111 78184 28994 110482010
Drug use disorder 96.45 11.33 89 78206 17985 110493019
Application site irritation 96.30 11.33 40 78255 1897 110509107
Drug intolerance 95.78 11.33 88 78207 406424 110104580
Arthralgia 94.53 11.33 263 78032 779369 109731635
Logorrhoea 94.41 11.33 53 78242 4904 110506100
Euphoric mood 93.50 11.33 65 78230 8762 110502242
Heart rate increased 92.38 11.33 267 78028 143567 110367437
Affect lability 92.21 11.33 88 78207 18549 110492455
Oromandibular dystonia 91.78 11.33 34 78261 1185 110509819
Obsessive-compulsive disorder 90.29 11.33 59 78236 7182 110503822
Hallucination, tactile 90.20 11.33 32 78263 983 110510021
Pulmonary malformation 89.59 11.33 23 78272 222 110510782
Contraindicated product administered 89.39 11.33 32 78263 248235 110262769
Somnambulism 89.31 11.33 56 78239 6349 110504655
Extrapyramidal disorder 88.97 11.33 106 78189 28761 110482243
Seizure 88.33 11.33 350 77945 220835 110290169
Treatment failure 88.14 11.33 43 78252 277191 110233813
Blister 87.69 11.33 26 78269 227350 110283654
Screaming 87.07 11.33 50 78245 4831 110506173
Dyspnoea 86.43 11.33 447 77848 1106425 109404579
Muscle injury 86.24 11.33 3 78292 140804 110370200
Death 84.51 11.33 236 78059 698633 109812371
Rheumatoid arthritis 84.40 11.33 54 78241 299559 110211445
Mobility decreased 83.13 11.33 32 78263 237390 110273614
Thrombocytopenia 82.80 11.33 75 78220 348810 110162194
Febrile neutropenia 81.44 11.33 63 78232 316704 110194300
Drug diversion 80.63 11.33 32 78263 1348 110509656
Reversible cerebral vasoconstriction syndrome 80.23 11.33 47 78248 4714 110506290
Infection 80.00 11.33 83 78212 362117 110148887
Wound 79.78 11.33 33 78262 234404 110276600
Mood swings 79.08 11.33 89 78206 22723 110488281
Impaired healing 78.63 11.33 21 78274 196696 110314308
Decreased eye contact 78.11 11.33 28 78267 887 110510117
Sleep apnoea syndrome 77.78 11.33 118 78177 40329 110470675
Tardive dyskinesia 76.63 11.33 69 78226 13510 110497494
Drug withdrawal syndrome 76.00 11.33 113 78182 37941 110473063
Product adhesion issue 73.66 11.33 38 78257 2968 110508036
Substance use disorder 73.30 11.33 52 78243 7238 110503766
Joint range of motion decreased 73.22 11.33 3 78292 121829 110389175
Autism spectrum disorder 73.16 11.33 33 78262 1915 110509089
Pyrexia 72.75 11.33 358 77937 897907 109613097
Sepsis 72.30 11.33 75 78220 327271 110183733
Neutropenia 71.85 11.33 96 78199 374524 110136480
Gynaecomastia 71.61 11.33 57 78238 9433 110501571
Inflammation 71.12 11.33 24 78271 193214 110317790
Chorea 71.04 11.33 38 78257 3197 110507807
Stomatitis 70.41 11.33 53 78242 270189 110240815
Application site pruritus 69.92 11.33 41 78254 4119 110506885
Incorrect product administration duration 69.40 11.33 79 78216 20419 110490585
Histiocytosis 69.12 11.33 15 78280 63 110510941
Hyperhidrosis 68.91 11.33 289 78006 187009 110323995
Kounis syndrome 68.37 11.33 46 78249 5879 110505125
Bursitis 67.00 11.33 7 78288 129911 110381093
Psoriatic arthropathy 66.46 11.33 28 78267 196733 110314271
Hepatic enzyme increased 65.94 11.33 78 78217 320814 110190190
Surgery 65.06 11.33 110 78185 41173 110469831
Multiple organ dysfunction syndrome 64.94 11.33 14 78281 151696 110359308
Irritable bowel syndrome 64.74 11.33 18 78277 164197 110346807
Interstitial lung disease 63.57 11.33 11 78284 139323 110371681
C-reactive protein increased 63.12 11.33 38 78257 217881 110293123
Ill-defined disorder 62.20 11.33 17 78278 156836 110354168
Sedation 61.80 11.33 146 78149 69537 110441467
Hallucinations, mixed 60.91 11.33 50 78245 8643 110502361
Generalised tonic-clonic seizure 60.28 11.33 125 78170 54555 110456449
Headache 60.23 11.33 917 77378 881460 109629544
Type 2 diabetes mellitus 60.21 11.33 25 78270 177207 110333797
Lung disorder 60.20 11.33 26 78269 180021 110330983
Suicidal behaviour 60.19 11.33 35 78260 3462 110507542
Gastrointestinal haemorrhage 60.14 11.33 21 78274 165497 110345507
Drug hypersensitivity 59.65 11.33 147 78148 453943 110057061
Maternal exposure during pregnancy 59.03 11.33 56 78239 254827 110256177
Increased appetite 58.11 11.33 62 78233 14915 110496089
Akathisia 58.01 11.33 66 78229 17047 110493957
Renal impairment 57.24 11.33 31 78264 188414 110322590
Rash 57.16 11.33 344 77951 820620 109690384
Lung cyst 56.63 11.33 19 78276 492 110510512
Product taste abnormal 56.10 11.33 30 78265 2522 110508482
Mental disorder 55.44 11.33 99 78196 38692 110472312
Delusion of parasitosis 55.21 11.33 16 78279 251 110510753
Arteriospasm coronary 54.85 11.33 48 78247 9052 110501952
Drug interaction 54.79 11.33 568 77727 499615 110011389
Petit mal epilepsy 54.12 11.33 44 78251 7503 110503501
Pulmonary fibrosis 53.92 11.33 5 78290 102037 110408967
Gastrointestinal disorder 53.90 11.33 55 78240 241897 110269107
Product tampering 53.83 11.33 18 78277 461 110510543
Therapeutic response unexpected 53.75 11.33 75 78220 23768 110487236
Social avoidant behaviour 53.30 11.33 38 78257 5331 110505673
Vision blurred 52.96 11.33 206 78089 128816 110382188
Hyperprolactinaemia 52.87 11.33 41 78254 6534 110504470
Change in sustained attention 52.62 11.33 10 78285 17 110510987
Pancytopenia 52.21 11.33 43 78252 209570 110301434
Oculogyric crisis 52.17 11.33 33 78262 3799 110507205
Feeling jittery 51.99 11.33 58 78237 14664 110496340
Liver disorder 51.76 11.33 18 78277 142225 110368779
Product administered to patient of inappropriate age 51.71 11.33 44 78251 7992 110503012
Social anxiety disorder 51.60 11.33 21 78274 945 110510059
Muscle twitching 51.53 11.33 83 78212 29852 110481152
Panic reaction 51.30 11.33 37 78258 5285 110505719
Osteoarthritis 51.29 11.33 33 78262 182590 110328414
Electrocardiogram QT prolonged 50.58 11.33 181 78114 108779 110402225
Alice in wonderland syndrome 50.17 11.33 11 78284 49 110510955
Lip dry 50.07 11.33 6 78289 100077 110410927
Adhesive tape use 50.03 11.33 8 78287 0 110511004
Affective disorder 49.86 11.33 50 78245 11191 110499813
Hyperkalaemia 49.73 11.33 17 78278 135779 110375225
Drug tolerance 49.63 11.33 60 78235 16525 110494479
Platelet count decreased 49.52 11.33 54 78241 230389 110280615
Bipolar disorder 49.32 11.33 45 78250 8962 110502042
Dermo-hypodermitis 48.98 11.33 23 78272 1465 110509539
Application site rash 48.86 11.33 27 78268 2423 110508581
Myelosuppression 48.86 11.33 5 78290 94335 110416669
Pre-existing condition improved 48.82 11.33 39 78256 6487 110504517
Cardiac failure congestive 48.61 11.33 23 78272 150977 110360027
Substance-induced psychotic disorder 48.42 11.33 36 78259 5388 110505616
Wheezing 48.31 11.33 66 78229 255164 110255840
Respiratory tract malformation 48.00 11.33 12 78283 103 110510901
Peripheral venous disease 47.61 11.33 3 78292 84114 110426890
Abdominal discomfort 47.52 11.33 133 78162 393725 110117279
Treatment noncompliance 47.32 11.33 136 78159 72854 110438150
Keratoconus 47.26 11.33 13 78282 167 110510837
Self-destructive behaviour 47.09 11.33 19 78276 836 110510168
Torticollis 47.03 11.33 29 78266 3192 110507812
Pain 46.59 11.33 442 77853 954513 109556491
Haemoglobin decreased 46.39 11.33 65 78230 248662 110262342
Nervousness 46.33 11.33 89 78206 36762 110474242
Poor sucking reflex 45.91 11.33 12 78283 125 110510879
Respiratory failure 45.67 11.33 51 78244 215281 110295723
Decreased appetite 45.48 11.33 526 77769 475320 110035684
Mycobacterium fortuitum infection 45.33 11.33 16 78279 484 110510520
Rapid eye movement sleep behaviour disorder 45.10 11.33 17 78278 622 110510382
Musculoskeletal pain 45.02 11.33 38 78257 182985 110328019
Claustrophobia 44.67 11.33 22 78273 1557 110509447
Hypersomnia 44.52 11.33 75 78220 27986 110483018
Hypotension 44.52 11.33 205 78090 523644 109987360
Product dose omission issue 44.46 11.33 384 77911 321398 110189606
Oedema peripheral 44.24 11.33 105 78190 328555 110182449
Thinking abnormal 44.05 11.33 54 78241 15086 110495918
Ventricular parasystole 43.78 11.33 7 78288 0 110511004
Exposure via breast milk 43.71 11.33 19 78276 1009 110509995
Septic shock 43.51 11.33 29 78266 157499 110353505
Mycobacterial peritonitis 43.40 11.33 13 78282 230 110510774
Loss of consciousness 43.19 11.33 262 78033 196044 110314960
Somatic symptom disorder 42.50 11.33 27 78268 3132 110507872
Sleep-related eating disorder 42.30 11.33 18 78277 907 110510097
Speech disorder 42.15 11.33 117 78178 61452 110449552
Oedema 42.10 11.33 52 78243 209924 110301080
Parasomnia 42.00 11.33 17 78278 754 110510250
Alopecia 41.93 11.33 126 78169 364627 110146377
Major depression 41.26 11.33 44 78251 10577 110500427
Therapeutic response changed 41.23 11.33 21 78274 1597 110509407
Lactation disorder 40.87 11.33 13 78282 283 110510721
Formication 40.65 11.33 33 78262 5615 110505389
Electrocardiogram QRS complex prolonged 40.43 11.33 48 78247 12973 110498031
Maternal exposure during breast feeding 39.79 11.33 29 78266 4209 110506795
Sudden death 39.77 11.33 66 78229 24329 110486675
Hypokinesia 39.61 11.33 62 78233 21764 110489240
Renal failure 39.54 11.33 62 78233 226512 110284492
Distractibility 39.45 11.33 17 78278 884 110510120
Dermatillomania 39.14 11.33 13 78282 326 110510678
Application site urticaria 38.87 11.33 12 78283 236 110510768
Musculoskeletal stiffness 38.78 11.33 88 78207 279734 110231270
Disease progression 38.70 11.33 71 78224 243963 110267041
Fear 38.15 11.33 63 78232 23130 110487874
Negative thoughts 38.02 11.33 20 78275 1626 110509378
Live birth 37.82 11.33 3 78292 69481 110441523
Pre-eclampsia 37.49 11.33 38 78257 8612 110502392
Body temperature increased 37.48 11.33 104 78191 54609 110456395
Disturbance in social behaviour 37.35 11.33 30 78265 5028 110505976
Amenorrhoea 37.21 11.33 39 78256 9192 110501812
Personality change 36.56 11.33 42 78253 10960 110500044
Narcolepsy 35.85 11.33 19 78276 1569 110509435
Blood cholesterol increased 35.76 11.33 47 78248 184738 110326266
Obsessive-compulsive symptom 35.54 11.33 12 78283 317 110510687
Peripheral coldness 35.51 11.33 54 78241 18486 110492518
Adulterated product 35.41 11.33 17 78278 1138 110509866
Raynaud's phenomenon 35.30 11.33 16 78279 939 110510065
Blood creatine phosphokinase increased 35.29 11.33 123 78172 72954 110438050
White blood cell count decreased 35.26 11.33 68 78227 229322 110281682
Mucosal inflammation 35.26 11.33 12 78283 96129 110414875
Hyperphagia 35.07 11.33 25 78270 3506 110507498
Stereotypy 34.34 11.33 16 78279 1001 110510003
Hypercholesterolaemia 33.91 11.33 11 78284 90826 110420178
Hypersensitivity 33.77 11.33 159 78136 403839 110107165
Wound infection 33.75 11.33 13 78282 96452 110414552
Incorrect dose administered 33.59 11.33 154 78141 103487 110407517
Pleural effusion 33.57 11.33 46 78249 177663 110333341
Product dispensing error 33.30 11.33 49 78246 16296 110494708
Hyponatraemia 33.04 11.33 65 78230 217588 110293416
Depersonalisation/derealisation disorder 32.77 11.33 20 78275 2161 110508843
Liver injury 32.58 11.33 35 78260 150378 110360626
Splenic infarction 32.42 11.33 26 78269 4348 110506656
Acute psychosis 31.46 11.33 27 78268 4960 110506044
Hypnagogic hallucination 31.38 11.33 10 78285 219 110510785
Hepatotoxicity 31.23 11.33 4 78291 63396 110447608
Cardiac failure 31.18 11.33 53 78242 187573 110323431
Hyperreflexia 31.17 11.33 36 78259 9449 110501555
School refusal 30.94 11.33 7 78288 37 110510967
Product prescribing error 30.75 11.33 93 78202 51238 110459766
Excessive eye blinking 30.30 11.33 18 78277 1852 110509152
Erection increased 30.29 11.33 11 78284 362 110510642
Hangover 30.25 11.33 20 78275 2482 110508522
Nail disorder 30.18 11.33 3 78292 57932 110453072
Initial insomnia 30.14 11.33 37 78258 10352 110500652
Burnout syndrome 29.65 11.33 11 78284 385 110510619
Sleep paralysis 29.63 11.33 14 78281 904 110510100
Hyperventilation 29.47 11.33 34 78261 8913 110502091
Rectal haemorrhage 29.32 11.33 25 78270 119808 110391196
Malignant neoplasm progression 29.29 11.33 49 78246 174518 110336486
Blood creatinine increased 29.18 11.33 53 78242 182836 110328168
Multiple sclerosis relapse 29.14 11.33 90 78205 50150 110460854
Urinary incontinence 29.08 11.33 88 78207 48499 110462505
Testicular failure 28.92 11.33 5 78290 3 110511001
Misophonia 28.92 11.33 5 78290 3 110511001
Tachyphrenia 28.89 11.33 19 78276 2337 110508667
Atrial fibrillation 28.84 11.33 76 78219 229566 110281438
Solar urticaria 28.65 11.33 8 78287 109 110510895
Product complaint 28.63 11.33 42 78253 13930 110497074
Hunger 28.60 11.33 29 78266 6575 110504429
Erythema 28.48 11.33 108 78187 291339 110219665
Self-injurious ideation 28.38 11.33 24 78271 4322 110506682
Benign rolandic epilepsy 28.33 11.33 5 78290 4 110511000
Hypocalcaemia 28.03 11.33 6 78289 65360 110445644
Delayed puberty 27.99 11.33 9 78286 203 110510801
Unresponsive to stimuli 27.93 11.33 104 78191 63686 110447318
Persecutory delusion 27.93 11.33 28 78267 6263 110504741
Hepatic adenoma 27.88 11.33 11 78284 456 110510548
Application site discolouration 27.86 11.33 14 78281 1035 110509969
Asthenia 27.83 11.33 333 77962 688666 109822338
Liver function test increased 27.72 11.33 14 78281 88534 110422470
Protrusion tongue 27.41 11.33 11 78284 477 110510527
Tongue biting 27.34 11.33 20 78275 2919 110508085
Arteriosclerosis coronary artery 27.19 11.33 57 78238 25061 110485943
Cytokine release syndrome 27.16 11.33 8 78287 70298 110440706
Hypersexuality 27.15 11.33 17 78278 1923 110509081
Fibromyalgia 26.84 11.33 50 78245 170859 110340145
Anti-transglutaminase antibody increased 26.79 11.33 6 78289 30 110510974
Scoliosis 26.79 11.33 32 78263 8701 110502303
Foetal exposure timing unspecified 26.78 11.33 7 78288 73 110510931
Red blood cell sedimentation rate increased 26.66 11.33 11 78284 78291 110432713
Binocular eye movement disorder 26.63 11.33 8 78287 143 110510861
Strabismus 26.36 11.33 21 78274 3478 110507526
Brain oedema 26.32 11.33 64 78231 31034 110479970
Eye movement disorder 25.60 11.33 33 78262 9695 110501309
Sciatica 25.52 11.33 17 78278 92382 110418622
Pica 25.51 11.33 7 78288 89 110510915
Arthritis 25.47 11.33 50 78245 167536 110343468
CSWS syndrome 25.46 11.33 6 78289 39 110510965
Congestive cardiomyopathy 25.26 11.33 40 78255 14179 110496825
Sympathomimetic effect 25.20 11.33 8 78287 173 110510831
Poor quality sleep 25.08 11.33 59 78236 28018 110482986
Poor quality product administered 25.04 11.33 23 78272 4618 110506386
Drug ineffective 25.03 11.33 1315 76980 1519225 108991779
Urine amphetamine negative 25.02 11.33 4 78291 0 110511004
Cardiac contusion 25.02 11.33 4 78291 0 110511004
Lower limb fracture 24.99 11.33 11 78284 75337 110435667
Vasospasm 24.92 11.33 15 78280 1581 110509423
Discomfort 24.78 11.33 74 78221 214633 110296371
Thyroid atrophy 24.73 11.33 9 78286 298 110510706
Status epilepticus 24.65 11.33 63 78232 31508 110479496
Melaena 24.50 11.33 9 78286 68748 110442256
Ataxia 24.46 11.33 61 78234 30047 110480957
Product availability issue 24.35 11.33 29 78266 7861 110503143
Hepatitis 24.30 11.33 17 78278 90037 110420967
Dermatitis atopic 24.27 11.33 55 78240 25486 110485518
Taste disorder 24.26 11.33 8 78287 65379 110445625
Behaviour disorder 24.26 11.33 32 78263 9615 110501389
Sinus tachycardia 24.24 11.33 78 78217 44415 110466589
Substance abuser 24.22 11.33 10 78285 467 110510537
Neutrophil count decreased 24.18 11.33 30 78265 120911 110390093
Mental impairment 24.07 11.33 51 78244 22588 110488416
Knee arthroplasty 24.00 11.33 8 78287 64940 110446064
Agranulocytosis 23.91 11.33 7 78288 61753 110449251
Pruritus 23.88 11.33 280 78015 581280 109929724
Drug abuser 23.88 11.33 24 78271 5385 110505619
Dysphoria 23.87 11.33 26 78269 6402 110504602
Lumbosacral radiculoplexus neuropathy 23.80 11.33 7 78288 116 110510888
Contusion 23.77 11.33 85 78210 233276 110277728
Bone marrow failure 23.44 11.33 6 78289 57842 110453162
Pulse abnormal 23.25 11.33 21 78274 4128 110506876
Tachypnoea 23.24 11.33 71 78224 39324 110471680
Substance use 23.19 11.33 17 78278 2489 110508515
Lactic acidosis 23.15 11.33 19 78276 92792 110418212
Nightmare 22.89 11.33 70 78225 38793 110472211
Wound infection fungal 22.89 11.33 8 78287 235 110510769
Cyanosis 22.86 11.33 59 78236 29682 110481322
Dissociative disorder 22.81 11.33 13 78282 1238 110509766
Toxic epidermal necrolysis 22.76 11.33 6 78289 56721 110454283
Optic disc haemorrhage 22.76 11.33 8 78287 239 110510765
Upper gastrointestinal haemorrhage 22.74 11.33 4 78291 50092 110460912
Rebound effect 22.73 11.33 39 78256 14767 110496237
Cardio-respiratory arrest 22.61 11.33 150 78145 115686 110395318
Open angle glaucoma 22.44 11.33 10 78285 564 110510440
Restless legs syndrome 22.27 11.33 52 78243 24574 110486430
Product colour issue 22.25 11.33 12 78283 1026 110509978
Hepatic cirrhosis 22.23 11.33 10 78285 67616 110443388
Onychomadesis 22.20 11.33 3 78292 45660 110465344
Device breakage 22.11 11.33 37 78258 13732 110497272
Wolff-Parkinson-White syndrome 22.07 11.33 9 78286 407 110510597
Compulsions 21.99 11.33 9 78286 411 110510593
Ascites 21.93 11.33 20 78275 92788 110418216
Defiant behaviour 21.89 11.33 6 78289 76 110510928
Grip strength decreased 21.81 11.33 15 78280 80159 110430845
Salivary hypersecretion 21.80 11.33 42 78253 17379 110493625
Blood pressure increased 21.76 11.33 279 78016 258094 110252910
Livedo reticularis 21.73 11.33 23 78272 5483 110505521
Coronary artery disease 21.46 11.33 12 78283 71678 110439326
Coordination abnormal 21.44 11.33 52 78243 25176 110485828
Artery dissection 21.37 11.33 9 78286 442 110510562
Hypomagnesaemia 21.34 11.33 8 78287 60362 110450642
Malaise 21.28 11.33 341 77954 671478 109839526
Injury 21.25 11.33 60 78235 177205 110333799
Chronic fatigue syndrome 21.21 11.33 13 78282 1416 110509588
Autoimmune disorder 21.03 11.33 10 78285 65473 110445531
Sexually inappropriate behaviour 20.95 11.33 10 78285 661 110510343
Bradyphrenia 20.84 11.33 33 78262 11695 110499309
Psychiatric symptom 20.79 11.33 29 78266 9184 110501820
Neuroleptic malignant syndrome 20.67 11.33 62 78233 33997 110477007
Orthodontic procedure 20.63 11.33 4 78291 8 110510996
Daydreaming 20.61 11.33 12 78283 1190 110509814
Psychotic symptom 20.55 11.33 19 78276 3848 110507156
Hyperthermia 20.43 11.33 46 78249 21226 110489778
Hip arthroplasty 20.41 11.33 7 78288 55806 110455198
Osteoporosis 20.33 11.33 19 78276 87133 110423871
Regurgitation 20.24 11.33 18 78277 3467 110507537
Psoriasis 20.23 11.33 43 78252 139950 110371054
Polydipsia psychogenic 20.22 11.33 8 78287 334 110510670
International normalised ratio increased 20.15 11.33 19 78276 86753 110424251
Arrhythmia 20.09 11.33 100 78195 69475 110441529
Cholestasis of pregnancy 20.04 11.33 12 78283 1253 110509751
Application site pain 20.00 11.33 22 78273 5477 110505527
Drug screen negative 19.89 11.33 8 78287 349 110510655
Paraesthesia ear 19.89 11.33 9 78286 526 110510478
Dysphemia 19.85 11.33 19 78276 4018 110506986
Suspiciousness 19.68 11.33 10 78285 757 110510247
Anaphylactic shock 19.67 11.33 6 78289 51540 110459464
Regressive behaviour 19.64 11.33 7 78288 218 110510786
Accidental exposure to product by child 19.54 11.33 17 78278 3181 110507823
Myocarditis 19.48 11.33 56 78239 29999 110481005
Pressure of speech 19.47 11.33 12 78283 1320 110509684
Illusion 19.45 11.33 14 78281 1993 110509011
Onychophagia 19.44 11.33 6 78289 118 110510886
Meningitis streptococcal 19.37 11.33 7 78288 227 110510777
Dyspepsia 19.15 11.33 70 78225 190895 110320109
Painful erection 19.11 11.33 7 78288 236 110510768
Lupus-like syndrome 19.09 11.33 3 78292 40789 110470215
Hypertension 18.97 11.33 484 77811 509600 110001404
Drug-induced liver injury 18.96 11.33 35 78260 120032 110390972
Staring 18.94 11.33 16 78279 2876 110508128
Foot fracture 18.94 11.33 50 78245 25496 110485508
Chronic obstructive pulmonary disease 18.91 11.33 30 78265 109128 110401876
Rash pruritic 18.91 11.33 25 78270 98044 110412960
Weight gain poor 18.90 11.33 12 78283 1390 110509614
Full blood count abnormal 18.88 11.33 8 78287 56044 110454960
Intentional dose omission 18.82 11.33 43 78252 20037 110490967
Gait inability 18.79 11.33 43 78252 136333 110374671
Animal phobia 18.76 11.33 3 78292 0 110511004
Cerebral arteritis 18.76 11.33 3 78292 0 110511004
Nail picking 18.76 11.33 3 78292 0 110511004
Limb girth decreased 18.76 11.33 3 78292 0 110511004
Rash maculo-papular 18.75 11.33 15 78280 74207 110436797
Hyperacusis 18.66 11.33 16 78279 2936 110508068
Disorientation 18.61 11.33 99 78196 70572 110440432
Hypomania 18.52 11.33 29 78266 10181 110500823
Tongue spasm 18.51 11.33 6 78289 139 110510865
Grimacing 18.49 11.33 10 78285 860 110510144
Phobia 18.44 11.33 8 78287 423 110510581
Dehydration 18.41 11.33 119 78176 279392 110231612
Incoherent 18.41 11.33 26 78269 8332 110502672
Gastric bypass 18.39 11.33 12 78283 1457 110509547
High density lipoprotein increased 18.39 11.33 12 78283 1457 110509547
Bundle branch block right 18.38 11.33 32 78263 12259 110498745
Eosinophilia 18.37 11.33 9 78286 57927 110453077
Product residue present 18.35 11.33 18 78277 3923 110507081
Cough 18.27 11.33 224 78071 461417 110049587
Hypoglycaemia 18.20 11.33 34 78261 116070 110394934
Antidepressant discontinuation syndrome 18.04 11.33 6 78289 151 110510853
Social problem 18.00 11.33 13 78282 1861 110509143
Electroencephalogram abnormal 17.93 11.33 22 78273 6151 110504853
Negativism 17.87 11.33 10 78285 919 110510085
Bipolar I disorder 17.84 11.33 14 78281 2269 110508735
Disinhibition 17.83 11.33 16 78279 3118 110507886
Muscle tightness 17.76 11.33 35 78260 14727 110496277
Dermal absorption impaired 17.70 11.33 4 78291 21 110510983
Upper respiratory tract infection 17.62 11.33 42 78253 131286 110379718
Terminal insomnia 17.61 11.33 13 78282 1925 110509079
Galactorrhoea 17.55 11.33 18 78277 4137 110506867
Drug eruption 17.53 11.33 8 78287 53651 110457353
Cataract subcapsular 17.52 11.33 11 78284 1250 110509754
X-ray abnormal 17.40 11.33 3 78292 38114 110472890
Chronic kidney disease 17.37 11.33 17 78278 76274 110434730
Atrioventricular block second degree 17.35 11.33 25 78270 8156 110502848
Mitral valve prolapse 17.34 11.33 14 78281 2364 110508640
Constipation 17.20 11.33 166 78129 357620 110153384
Concussion 17.20 11.33 30 78265 11508 110499496
Tourette's disorder 17.10 11.33 5 78290 81 110510923
Night sweats 17.07 11.33 44 78251 133939 110377065
Obesity 17.07 11.33 34 78261 113317 110397687
Wrong product administered 17.00 11.33 29 78266 10931 110500073
Sensory level abnormal 16.98 11.33 6 78289 182 110510822
Lethargy 16.97 11.33 119 78176 93457 110417547
Talipes 16.95 11.33 6 78289 183 110510821
Soliloquy 16.94 11.33 10 78285 1017 110509987
Hypertonia 16.84 11.33 25 78270 8381 110502623
COVID-19 pneumonia 16.79 11.33 3 78292 37140 110473864
Oxygen saturation decreased 16.78 11.33 56 78239 156926 110354078
Herpes zoster 16.76 11.33 32 78263 108347 110402657
Acne 16.69 11.33 57 78238 33463 110477541
Bisexuality 16.68 11.33 3 78292 3 110511001
Application site erosion 16.67 11.33 7 78288 341 110510663
Opisthotonus 16.61 11.33 9 78286 777 110510227
Erectile dysfunction 16.58 11.33 39 78256 18517 110492487
Nasopharyngitis 16.51 11.33 189 78106 394172 110116832
Respiratory depression 16.44 11.33 55 78240 31946 110479058
Sopor 16.41 11.33 3 78292 36543 110474461
Abdominal distension 16.39 11.33 66 78229 175037 110335967
Eosinophilic pneumonia chronic 16.34 11.33 8 78287 559 110510445
Anal incontinence 16.29 11.33 43 78252 21921 110489083
Pneumocystis jirovecii pneumonia 16.26 11.33 5 78290 42730 110468274
Foetal exposure during pregnancy 16.02 11.33 23 78272 7482 110503522
Neurotoxicity 15.95 11.33 5 78290 42202 110468802
Nystagmus 15.84 11.33 29 78266 11548 110499456
Cerebral congestion 15.75 11.33 6 78289 226 110510778
Drug reaction with eosinophilia and systemic symptoms 15.75 11.33 21 78274 82074 110428930
Dependence 15.66 11.33 14 78281 2715 110508289
Removal of foreign body from eye 15.47 11.33 3 78292 6 110510998
Abnormal sleep-related event 15.41 11.33 9 78286 897 110510107
Libido decreased 15.41 11.33 20 78275 5915 110505089
Sinusitis 15.41 11.33 135 78160 296553 110214451
Accidental overdose 15.32 11.33 75 78220 51759 110459245
Neurological symptom 15.27 11.33 34 78261 15574 110495430
Asthma 15.26 11.33 109 78186 250182 110260822
Pelvic inflammatory disease 15.26 11.33 11 78284 1569 110509435
Post-traumatic stress disorder 15.24 11.33 21 78274 6575 110504429
Intracranial pressure increased 15.20 11.33 27 78268 10508 110500496
Brain injury 15.08 11.33 31 78264 13445 110497559
Food craving 15.05 11.33 12 78283 1991 110509013
Hepatic function abnormal 15.04 11.33 25 78270 89270 110421734
Hepatitis C RNA 15.03 11.33 4 78291 45 110510959
Myelodysplastic syndrome 14.97 11.33 4 78291 37480 110473524
Physical assault 14.97 11.33 11 78284 1617 110509387
Acute myocardial infarction 14.87 11.33 106 78189 83671 110427333
Epiphyses delayed fusion 14.87 11.33 3 78292 8 110510996
Encopresis 14.74 11.33 5 78290 134 110510870
Sudden onset of sleep 14.66 11.33 8 78287 700 110510304
Muscle discomfort 14.60 11.33 7 78288 467 110510537
Tension 14.59 11.33 18 78277 5060 110505944
Intrusive thoughts 14.53 11.33 8 78287 713 110510291
Perinatal depression 14.38 11.33 7 78288 483 110510521
Schizotypal personality disorder 14.37 11.33 3 78292 10 110510994
Plasma cell myeloma 14.36 11.33 14 78281 62922 110448082
Tooth discolouration 14.35 11.33 10 78285 1353 110509651
Gastrooesophageal reflux disease 14.34 11.33 72 78223 179904 110331100
Impaired driving ability 14.30 11.33 20 78275 6350 110504654
Prescribed underdose 14.29 11.33 15 78280 65159 110445845
Blood prolactin increased 14.23 11.33 17 78278 4625 110506379
Menstruation irregular 14.22 11.33 19 78276 5778 110505226
Drug screen positive 14.20 11.33 20 78275 6390 110504614
Heavy menstrual bleeding 14.19 11.33 34 78261 16331 110494673
Pain in extremity 14.18 11.33 251 78044 486867 110024137
Visual snow syndrome 14.16 11.33 4 78291 57 110510947
Stress 14.15 11.33 125 78170 105223 110405781
Diplopia 14.13 11.33 63 78232 41831 110469173
Impulse-control disorder 14.09 11.33 12 78283 2182 110508822
Neoplasm progression 14.02 11.33 15 78280 64580 110446424
Haematochezia 13.92 11.33 39 78256 115485 110395519
Muscle rigidity 13.89 11.33 43 78252 23988 110487016
Abnormal dreams 13.83 11.33 29 78266 12751 110498253
Renal disorder 13.80 11.33 9 78286 49470 110461534
Adjustment disorder with depressed mood 13.64 11.33 7 78288 43876 110467128
Long QT syndrome congenital 13.61 11.33 5 78290 170 110510834
Clumsiness 13.53 11.33 15 78280 3765 110507239
Productive cough 13.47 11.33 39 78256 114266 110396738
Feeling drunk 13.45 11.33 18 78277 5482 110505522
Hypokalaemia 13.42 11.33 75 78220 182373 110328631
Mechanical ventilation 13.38 11.33 14 78281 3293 110507711
Endotracheal intubation 13.36 11.33 19 78276 6125 110504879
Gastric banding 13.34 11.33 4 78291 71 110510933
Snoring 13.34 11.33 20 78275 6764 110504240
Shock 13.33 11.33 11 78284 53577 110457427
Antisocial behaviour 13.15 11.33 8 78287 860 110510144
Product physical issue 13.12 11.33 17 78278 5019 110505985
Therapy non-responder 13.07 11.33 62 78233 157245 110353759
Nasal necrosis 13.06 11.33 5 78290 191 110510813
Ideas of reference 13.06 11.33 5 78290 191 110510813
Idiopathic intracranial hypertension 12.99 11.33 15 78280 3937 110507067
Frequent bowel movements 12.96 11.33 19 78276 71371 110439633
Injection site abscess 12.94 11.33 11 78284 1995 110509009
Illness 12.91 11.33 101 78194 82070 110428934
Insulin-like growth factor decreased 12.90 11.33 7 78288 606 110510398
Pseudolymphoma 12.86 11.33 9 78286 1226 110509778
Device mechanical issue 12.85 11.33 11 78284 2013 110508991
Panic disorder 12.85 11.33 14 78281 3447 110507557
Sydenham's chorea 12.80 11.33 3 78292 19 110510985
Uterine haemorrhage 12.74 11.33 14 78281 3480 110507524
Pericardial effusion 12.74 11.33 13 78282 57204 110453800
Colitis 12.73 11.33 34 78261 102289 110408715
Memory impairment 12.71 11.33 203 78092 196741 110314263
Orthosis user 12.67 11.33 4 78291 85 110510919
Antiphospholipid syndrome 12.64 11.33 12 78283 2511 110508493
Sleep talking 12.64 11.33 9 78286 1259 110509745
Dyspnoea exertional 12.63 11.33 35 78260 104025 110406979
Splenic artery thrombosis 12.62 11.33 4 78291 86 110510918
Water intoxication 12.41 11.33 8 78287 951 110510053
Inappropriate affect 12.38 11.33 10 78285 1689 110509315
Urine sodium increased 12.35 11.33 5 78290 222 110510782
Hepatitis C virus test positive 12.31 11.33 6 78289 415 110510589
Application site scab 12.29 11.33 5 78290 225 110510779
Bradypnoea 12.26 11.33 22 78273 8627 110502377
Insulin resistance 12.20 11.33 10 78285 1724 110509280
Psychological abuse 12.19 11.33 3 78292 24 110510980
Multiple sclerosis 12.18 11.33 43 78252 25655 110485349
Leukopenia 12.15 11.33 59 78236 148732 110362272
Intraocular pressure increased 12.14 11.33 25 78270 10851 110500153
Streptococcal infection 12.12 11.33 25 78270 10865 110500139
Palmar-plantar erythrodysaesthesia syndrome 12.09 11.33 7 78288 41018 110469986
Alcoholic 12.08 11.33 3 78292 25 110510979
Peritonitis 12.08 11.33 4 78291 32603 110478401
Obstructive airways disorder 12.07 11.33 9 78286 46140 110464864
Meningitis staphylococcal 12.06 11.33 5 78290 236 110510768
Gilbert's syndrome 11.97 11.33 3 78292 26 110510978
Third stage postpartum haemorrhage 11.97 11.33 3 78292 26 110510978
Deafness bilateral 11.94 11.33 12 78283 2692 110508312
Mitral valve incompetence 11.91 11.33 51 78244 33278 110477726
Infectious mononucleosis 11.88 11.33 11 78284 2231 110508773
Dyslalia 11.86 11.33 9 78286 1388 110509616
Hepatocellular injury 11.86 11.33 11 78284 50631 110460373
Dysmetria 11.85 11.33 9 78286 1390 110509614
High risk sexual behaviour 11.76 11.33 4 78291 108 110510896
Viral myocarditis 11.72 11.33 7 78288 727 110510277
Prostate cancer 11.71 11.33 6 78289 37635 110473369
Cardiac arrest 11.66 11.33 200 78095 196553 110314451
Autophobia 11.59 11.33 3 78292 30 110510974
Learning disorder 11.57 11.33 7 78288 745 110510259
Cardiac fibrillation 11.53 11.33 8 78287 1074 110509930
Pulmonary mass 11.52 11.33 6 78289 37295 110473709
Theft 11.49 11.33 5 78290 266 110510738
Postural orthostatic tachycardia syndrome 11.49 11.33 10 78285 1872 110509132
Pneumonitis 11.48 11.33 23 78272 76508 110434496
Thrombosis 11.45 11.33 39 78256 108623 110402381
Depressive symptom 11.42 11.33 21 78274 8393 110502611
Electrocardiogram ST segment elevation 11.36 11.33 22 78273 9138 110501866
Product use in unapproved indication 11.34 11.33 236 78059 447141 110063863

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 D000697 Central Nervous System Stimulants
MeSH PA D014179 Neurotransmitter Uptake Inhibitors
MeSH PA D015259 Dopamine Agents
MeSH PA D018377 Neurotransmitter Agents
MeSH PA D018765 Dopamine Uptake Inhibitors
MeSH PA D049990 Membrane Transport Modulators
CHEBI has role CHEBI:35337 central nervous system stimulant
CHEBI has role CHEBI:35469 antidepressant
CHEBI has role CHEBI:35471 psychotropic drug
CHEBI has role CHEBI:35476 antipsychotic agent
CHEBI has role CHEBI:35480 analgesic
CHEBI has role CHEBI:35524 sympathomimetic agent
CHEBI has role CHEBI:35610 antineoplastic agent
CHEBI has role CHEBI:35640 adrenergic uptake inhibitor
CHEBI has role CHEBI:35705 immunosuppressive agent
CHEBI has role CHEBI:37962 adrenergic agent
CHEBI has role CHEBI:48407 antiparkinson drug
CHEBI has role CHEBI:50514 vasoconstrictor agent
CHEBI has role CHEBI:51039 dopamine uptake inhibitor
CHEBI has role CHEBI:63726 neuroprotective agent
CHEBI has role CHEBI:75835 anti-anaemic agent
FDA PE N0000175729 Central Nervous System Stimulation
FDA EPC N0000175739 Central Nervous System Stimulant

Related Drugs by ATC class:

N06BA Centrally acting sympathomimetics 14 drugs
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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




🐶 Veterinary Drug Use

None

🐶 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
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 11911518 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 11911518 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 11911518 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 11911518 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 11911518 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 KNOA PHARMA N212038 Feb. 27, 2019 DISCN CAPSULE, EXTENDED RELEASE ORAL 10111839 Oct. 30, 2035 METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
25MG ADHANSIA XR KNOA PHARMA N212038 Feb. 27, 2019 DISCN CAPSULE, EXTENDED RELEASE ORAL 10292939 Oct. 30, 2035 METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
25MG ADHANSIA XR KNOA PHARMA N212038 Feb. 27, 2019 DISCN CAPSULE, EXTENDED RELEASE ORAL 10449159 Oct. 30, 2035 METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
25MG ADHANSIA XR KNOA PHARMA N212038 Feb. 27, 2019 DISCN CAPSULE, EXTENDED RELEASE ORAL 10500162 Oct. 30, 2035 METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
25MG ADHANSIA XR KNOA PHARMA N212038 Feb. 27, 2019 DISCN CAPSULE, EXTENDED RELEASE ORAL 10512613 Oct. 30, 2035 METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
25MG ADHANSIA XR KNOA PHARMA N212038 Feb. 27, 2019 DISCN CAPSULE, EXTENDED RELEASE ORAL 10568841 Oct. 30, 2035 METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
35MG ADHANSIA XR KNOA PHARMA N212038 Feb. 27, 2019 DISCN CAPSULE, EXTENDED RELEASE ORAL 10111839 Oct. 30, 2035 METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
35MG ADHANSIA XR KNOA PHARMA N212038 Feb. 27, 2019 DISCN CAPSULE, EXTENDED RELEASE ORAL 10292939 Oct. 30, 2035 METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
35MG ADHANSIA XR KNOA PHARMA N212038 Feb. 27, 2019 DISCN CAPSULE, EXTENDED RELEASE ORAL 10449159 Oct. 30, 2035 METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
35MG ADHANSIA XR KNOA PHARMA N212038 Feb. 27, 2019 DISCN CAPSULE, EXTENDED RELEASE ORAL 10500162 Oct. 30, 2035 METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
35MG ADHANSIA XR KNOA PHARMA N212038 Feb. 27, 2019 DISCN CAPSULE, EXTENDED RELEASE ORAL 10512613 Oct. 30, 2035 METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
35MG ADHANSIA XR KNOA PHARMA N212038 Feb. 27, 2019 DISCN CAPSULE, EXTENDED RELEASE ORAL 10568841 Oct. 30, 2035 METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
45MG ADHANSIA XR KNOA PHARMA N212038 Feb. 27, 2019 DISCN CAPSULE, EXTENDED RELEASE ORAL 10111839 Oct. 30, 2035 METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
45MG ADHANSIA XR KNOA PHARMA N212038 Feb. 27, 2019 DISCN CAPSULE, EXTENDED RELEASE ORAL 10292939 Oct. 30, 2035 METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
45MG ADHANSIA XR KNOA PHARMA N212038 Feb. 27, 2019 DISCN CAPSULE, EXTENDED RELEASE ORAL 10449159 Oct. 30, 2035 METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
45MG ADHANSIA XR KNOA PHARMA N212038 Feb. 27, 2019 DISCN CAPSULE, EXTENDED RELEASE ORAL 10500162 Oct. 30, 2035 METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
45MG ADHANSIA XR KNOA PHARMA N212038 Feb. 27, 2019 DISCN CAPSULE, EXTENDED RELEASE ORAL 10512613 Oct. 30, 2035 METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
45MG ADHANSIA XR KNOA PHARMA N212038 Feb. 27, 2019 DISCN CAPSULE, EXTENDED RELEASE ORAL 10568841 Oct. 30, 2035 METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
55MG ADHANSIA XR KNOA PHARMA N212038 Feb. 27, 2019 DISCN CAPSULE, EXTENDED RELEASE ORAL 10111839 Oct. 30, 2035 METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
55MG ADHANSIA XR KNOA PHARMA N212038 Feb. 27, 2019 DISCN CAPSULE, EXTENDED RELEASE ORAL 10292939 Oct. 30, 2035 METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
55MG ADHANSIA XR KNOA PHARMA N212038 Feb. 27, 2019 DISCN CAPSULE, EXTENDED RELEASE ORAL 10449159 Oct. 30, 2035 METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
55MG ADHANSIA XR KNOA PHARMA N212038 Feb. 27, 2019 DISCN CAPSULE, EXTENDED RELEASE ORAL 10500162 Oct. 30, 2035 METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
55MG ADHANSIA XR KNOA PHARMA N212038 Feb. 27, 2019 DISCN CAPSULE, EXTENDED RELEASE ORAL 10512613 Oct. 30, 2035 METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
55MG ADHANSIA XR KNOA PHARMA N212038 Feb. 27, 2019 DISCN CAPSULE, EXTENDED RELEASE ORAL 10568841 Oct. 30, 2035 METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
70MG ADHANSIA XR KNOA PHARMA N212038 Feb. 27, 2019 DISCN CAPSULE, EXTENDED RELEASE ORAL 10111839 Oct. 30, 2035 METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
70MG ADHANSIA XR KNOA PHARMA N212038 Feb. 27, 2019 DISCN CAPSULE, EXTENDED RELEASE ORAL 10292939 Oct. 30, 2035 METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
70MG ADHANSIA XR KNOA PHARMA N212038 Feb. 27, 2019 DISCN CAPSULE, EXTENDED RELEASE ORAL 10449159 Oct. 30, 2035 METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
70MG ADHANSIA XR KNOA PHARMA N212038 Feb. 27, 2019 DISCN CAPSULE, EXTENDED RELEASE ORAL 10500162 Oct. 30, 2035 METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
70MG ADHANSIA XR KNOA PHARMA N212038 Feb. 27, 2019 DISCN CAPSULE, EXTENDED RELEASE ORAL 10512613 Oct. 30, 2035 METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
70MG ADHANSIA XR KNOA PHARMA N212038 Feb. 27, 2019 DISCN CAPSULE, EXTENDED RELEASE ORAL 10568841 Oct. 30, 2035 METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
85MG ADHANSIA XR KNOA PHARMA N212038 Feb. 27, 2019 DISCN CAPSULE, EXTENDED RELEASE ORAL 10111839 Oct. 30, 2035 METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
85MG ADHANSIA XR KNOA PHARMA N212038 Feb. 27, 2019 DISCN CAPSULE, EXTENDED RELEASE ORAL 10292939 Oct. 30, 2035 METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
85MG ADHANSIA XR KNOA PHARMA N212038 Feb. 27, 2019 DISCN CAPSULE, EXTENDED RELEASE ORAL 10449159 Oct. 30, 2035 METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
85MG ADHANSIA XR KNOA PHARMA N212038 Feb. 27, 2019 DISCN CAPSULE, EXTENDED RELEASE ORAL 10500162 Oct. 30, 2035 METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
85MG ADHANSIA XR KNOA PHARMA N212038 Feb. 27, 2019 DISCN CAPSULE, EXTENDED RELEASE ORAL 10512613 Oct. 30, 2035 METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
85MG ADHANSIA XR KNOA PHARMA N212038 Feb. 27, 2019 DISCN CAPSULE, EXTENDED RELEASE ORAL 10568841 Oct. 30, 2035 METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
18MG RELEXXII OSMOTICA PHARM US N216117 June 23, 2022 RX TABLET, EXTENDED RELEASE ORAL 10265308 Feb. 3, 2037 TREATMENT OF ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
18MG RELEXXII OSMOTICA PHARM US N216117 June 23, 2022 RX TABLET, EXTENDED RELEASE ORAL 10695336 Feb. 3, 2037 TREATMENT OF ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
18MG RELEXXII OSMOTICA PHARM US N216117 June 23, 2022 RX TABLET, EXTENDED RELEASE ORAL 9827234 Feb. 3, 2037 TREATMENT OF ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
18MG RELEXXII OSMOTICA PHARM US N216117 June 23, 2022 RX TABLET, EXTENDED RELEASE ORAL 9855258 Feb. 3, 2037 TREATMENT OF ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
27MG RELEXXII OSMOTICA PHARM US N216117 June 23, 2022 RX TABLET, EXTENDED RELEASE ORAL 10265308 Feb. 3, 2037 TREATMENT OF ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
27MG RELEXXII OSMOTICA PHARM US N216117 June 23, 2022 RX TABLET, EXTENDED RELEASE ORAL 10695336 Feb. 3, 2037 TREATMENT OF ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
27MG RELEXXII OSMOTICA PHARM US N216117 June 23, 2022 RX TABLET, EXTENDED RELEASE ORAL 9827234 Feb. 3, 2037 TREATMENT OF ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
27MG RELEXXII OSMOTICA PHARM US N216117 June 23, 2022 RX TABLET, EXTENDED RELEASE ORAL 9855258 Feb. 3, 2037 TREATMENT OF ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
36MG RELEXXII OSMOTICA PHARM US N216117 June 23, 2022 RX TABLET, EXTENDED RELEASE ORAL 10265308 Feb. 3, 2037 TREATMENT OF ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
36MG RELEXXII OSMOTICA PHARM US N216117 June 23, 2022 RX TABLET, EXTENDED RELEASE ORAL 10695336 Feb. 3, 2037 TREATMENT OF ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
36MG RELEXXII OSMOTICA PHARM US N216117 June 23, 2022 RX TABLET, EXTENDED RELEASE ORAL 9827234 Feb. 3, 2037 TREATMENT OF ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
36MG RELEXXII OSMOTICA PHARM US N216117 June 23, 2022 RX TABLET, EXTENDED RELEASE ORAL 9855258 Feb. 3, 2037 TREATMENT OF ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
45MG RELEXXII OSMOTICA PHARM US N216117 June 23, 2022 RX TABLET, EXTENDED RELEASE ORAL 10265308 Feb. 3, 2037 TREATMENT OF ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
45MG RELEXXII OSMOTICA PHARM US N216117 June 23, 2022 RX TABLET, EXTENDED RELEASE ORAL 10695336 Feb. 3, 2037 TREATMENT OF ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
45MG RELEXXII OSMOTICA PHARM US N216117 June 23, 2022 RX TABLET, EXTENDED RELEASE ORAL 9827234 Feb. 3, 2037 TREATMENT OF ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
45MG RELEXXII OSMOTICA PHARM US N216117 June 23, 2022 RX TABLET, EXTENDED RELEASE ORAL 9855258 Feb. 3, 2037 TREATMENT OF ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
54MG RELEXXII OSMOTICA PHARM US N216117 June 23, 2022 RX TABLET, EXTENDED RELEASE ORAL 10265308 Feb. 3, 2037 TREATMENT OF ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
54MG RELEXXII OSMOTICA PHARM US N216117 June 23, 2022 RX TABLET, EXTENDED RELEASE ORAL 10695336 Feb. 3, 2037 TREATMENT OF ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
54MG RELEXXII OSMOTICA PHARM US N216117 June 23, 2022 RX TABLET, EXTENDED RELEASE ORAL 9827234 Feb. 3, 2037 TREATMENT OF ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
54MG RELEXXII OSMOTICA PHARM US N216117 June 23, 2022 RX TABLET, EXTENDED RELEASE ORAL 9855258 Feb. 3, 2037 TREATMENT OF ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
63MG RELEXXII OSMOTICA PHARM US N216117 June 23, 2022 RX TABLET, EXTENDED RELEASE ORAL 10265308 Feb. 3, 2037 TREATMENT OF ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
63MG RELEXXII OSMOTICA PHARM US N216117 June 23, 2022 RX TABLET, EXTENDED RELEASE ORAL 10695336 Feb. 3, 2037 TREATMENT OF ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
63MG RELEXXII OSMOTICA PHARM US N216117 June 23, 2022 RX TABLET, EXTENDED RELEASE ORAL 9827234 Feb. 3, 2037 TREATMENT OF ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
63MG RELEXXII OSMOTICA PHARM US N216117 June 23, 2022 RX TABLET, EXTENDED RELEASE ORAL 9855258 Feb. 3, 2037 TREATMENT OF ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
72MG RELEXXII OSMOTICA PHARM US N216117 June 23, 2022 RX TABLET, EXTENDED RELEASE ORAL 10265308 Feb. 3, 2037 TREATMENT OF ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
72MG RELEXXII OSMOTICA PHARM US N216117 June 23, 2022 RX TABLET, EXTENDED RELEASE ORAL 10695336 Feb. 3, 2037 TREATMENT OF ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
72MG RELEXXII OSMOTICA PHARM US N216117 June 23, 2022 RX TABLET, EXTENDED RELEASE ORAL 9827234 Feb. 3, 2037 TREATMENT OF ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
72MG RELEXXII OSMOTICA PHARM US N216117 June 23, 2022 RX TABLET, EXTENDED RELEASE ORAL 9855258 Feb. 3, 2037 TREATMENT OF 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 KNOA PHARMA N212038 Feb. 27, 2019 DISCN CAPSULE, EXTENDED RELEASE ORAL 10722473 Nov. 19, 2038 METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
35MG ADHANSIA XR KNOA PHARMA N212038 Feb. 27, 2019 DISCN CAPSULE, EXTENDED RELEASE ORAL 10722473 Nov. 19, 2038 METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
45MG ADHANSIA XR KNOA PHARMA N212038 Feb. 27, 2019 DISCN CAPSULE, EXTENDED RELEASE ORAL 10722473 Nov. 19, 2038 METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
55MG ADHANSIA XR KNOA PHARMA N212038 Feb. 27, 2019 DISCN CAPSULE, EXTENDED RELEASE ORAL 10722473 Nov. 19, 2038 METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
70MG ADHANSIA XR KNOA PHARMA N212038 Feb. 27, 2019 DISCN CAPSULE, EXTENDED RELEASE ORAL 10722473 Nov. 19, 2038 METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
85MG ADHANSIA XR KNOA PHARMA 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)

None

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
400100 MMSL
5092 MMSL
d00900 MMSL
001540 NDDF
004619 NDDF
18548003 SNOMEDCT_US
373337007 SNOMEDCT_US
42163009 SNOMEDCT_US
20748-11-2 SECONDARY_CAS_RN
207ZZ9QZ49 INXIGHT DRUGS

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
RitalinLA HUMAN PRESCRIPTION DRUG LABEL 1 0078-0370 CAPSULE, EXTENDED RELEASE 20 mg ORAL NDA 32 sections
RitalinLA HUMAN PRESCRIPTION DRUG LABEL 1 0078-0371 CAPSULE, EXTENDED RELEASE 30 mg ORAL NDA 32 sections
RitalinLA HUMAN PRESCRIPTION DRUG LABEL 1 0078-0372 CAPSULE, EXTENDED RELEASE 40 mg ORAL NDA 32 sections
RitalinLA HUMAN PRESCRIPTION DRUG LABEL 1 0078-0424 CAPSULE, EXTENDED RELEASE 10 mg ORAL NDA 32 sections
Ritalin HUMAN PRESCRIPTION DRUG LABEL 1 0078-0439 TABLET 5 mg ORAL NDA 30 sections
Ritalin HUMAN PRESCRIPTION DRUG LABEL 1 0078-0440 TABLET 10 mg ORAL NDA 30 sections
Ritalin HUMAN PRESCRIPTION DRUG LABEL 1 0078-0441 TABLET 20 mg ORAL NDA 30 sections
Methylphenidate Hydrochloride(LA) HUMAN PRESCRIPTION DRUG LABEL 1 0093-5346 CAPSULE, EXTENDED RELEASE 20 mg ORAL ANDA 29 sections
Methylphenidate Hydrochloride(LA) HUMAN PRESCRIPTION DRUG LABEL 1 0093-5347 CAPSULE, EXTENDED RELEASE 30 mg ORAL ANDA 29 sections
Methylphenidate Hydrochloride(LA) HUMAN PRESCRIPTION DRUG LABEL 1 0093-5348 CAPSULE, EXTENDED RELEASE 40 mg ORAL ANDA 29 sections
Methylphenidate Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0115-1736 CAPSULE, EXTENDED RELEASE 10 mg ORAL ANDA 29 sections
Methylphenidate Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0115-1736 CAPSULE, EXTENDED RELEASE 10 mg ORAL ANDA 29 sections
Methylphenidate Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0115-1737 CAPSULE, EXTENDED RELEASE 20 mg ORAL ANDA 29 sections
Methylphenidate Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0115-1737 CAPSULE, EXTENDED RELEASE 20 mg ORAL ANDA 29 sections
Methylphenidate Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0115-1738 CAPSULE, EXTENDED RELEASE 30 mg ORAL ANDA 29 sections
Methylphenidate Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0115-1738 CAPSULE, EXTENDED RELEASE 30 mg ORAL ANDA 29 sections
Methylphenidate Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0115-1739 CAPSULE, EXTENDED RELEASE 40 mg ORAL ANDA 29 sections
Methylphenidate Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0115-1739 CAPSULE, EXTENDED RELEASE 40 mg ORAL ANDA 29 sections
Methylphenidate Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0115-1740 CAPSULE, EXTENDED RELEASE 50 mg ORAL ANDA 29 sections
Methylphenidate Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0115-1740 CAPSULE, EXTENDED RELEASE 50 mg ORAL ANDA 29 sections
Methylphenidate Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0115-1741 CAPSULE, EXTENDED RELEASE 60 mg ORAL ANDA 29 sections
Methylphenidate Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0115-1741 CAPSULE, EXTENDED RELEASE 60 mg ORAL ANDA 29 sections
METHYLPHENIDATE HYDROCHLORIDE HUMAN PRESCRIPTION DRUG LABEL 1 0115-1800 TABLET 5 mg ORAL ANDA 27 sections
METHYLPHENIDATE HYDROCHLORIDE HUMAN PRESCRIPTION DRUG LABEL 1 0115-1801 TABLET 10 mg ORAL ANDA 27 sections
METHYLPHENIDATE HYDROCHLORIDE HUMAN PRESCRIPTION DRUG LABEL 1 0115-1802 TABLET 20 mg ORAL ANDA 27 sections
Methylphenidate HUMAN PRESCRIPTION DRUG LABEL 1 0378-8260 PATCH 1.10 mg TRANSDERMAL ANDA 36 sections
Methylphenidate HUMAN PRESCRIPTION DRUG LABEL 1 0378-8260 PATCH 1.10 mg TRANSDERMAL ANDA 36 sections
Methylphenidate HUMAN PRESCRIPTION DRUG LABEL 1 0378-8261 PATCH 1.60 mg TRANSDERMAL ANDA 36 sections
Methylphenidate HUMAN PRESCRIPTION DRUG LABEL 1 0378-8261 PATCH 1.60 mg TRANSDERMAL ANDA 36 sections
Methylphenidate HUMAN PRESCRIPTION DRUG LABEL 1 0378-8262 PATCH 2.20 mg TRANSDERMAL ANDA 36 sections