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

Stem definitionDrug idCAS RN
anorexics 435 34911-55-2

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • bupropion
  • (+/-)-Bupropion
  • amfebutamon
  • amfebutamone
  • aplenzin
  • elontril
  • bupropion hydrochloride
  • bupropion hydrobromide
  • bupropion HCl
  • wellbutrin
A propiophenone-derived antidepressant and antismoking agent that inhibits the uptake of DOPAMINE.
  • Molecular weight: 239.74
  • Formula: C13H18ClNO
  • CLOGP: 3.21
  • LIPINSKI: 0
  • HAC: 2
  • HDO: 1
  • TPSA: 29.10
  • ALOGS: -3.54
  • ROTB: 4

  • Status: OFP

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

Drug dosage:

DoseUnitRoute
0.30 g O

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 1 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 312 mg/mL Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 0.50 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 31.28 µM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
fu (Fraction unbound in plasma) 0.14 % Kawashima H, Watanabe R, Esaki T, Kuroda M, Nagao C, Natsume-Kitatani Y, Ohashi R, Komura H, Mizuguchi K
BA (Bioavailability) 12.50 %

Predicted pharmacokinetic/toxicological properties (PK-AZ):

PropertyDescriptionValueUnitConfidenceSimilarity
kinase-safety-class ACVR2A,ACVR2B,AKT1,AKT2,AKT3,AXL,BRAF,BTK,CAMK2B,CAMK2D,CDK4,CDK5,CDK9,DDR1,DYRK1B,EIF2AK3,EPHB4,ERBB2,FLT3,GRK2,ITK,JAK2,JAK3,MAP3K21,MAP3K7,MAPK10,MAPK12,MAPK7,MAPK9,MAPKAPK2,MET,MTOR,NTRK2,PAK4,PDK1,PDK2,PDK4,PDPK1,PIK3CB,PIK3CG,PIM2,PRKCD,PRKDC,SIK2,SIK3,STK33,SYK,TEK,TGFBR1,TTK,ZAP70 51
kinase-selectivity-class AXL,BRAF,EIF2AK3,GRK2,PDK4 5
pfas-class PFAS structural alert (1 = True, 0 = False) 0
pld-class Phospholipidosis risk class (1 = positive, 0 = negative) 0 High 1

Approvals:

DateAgencyCompanyOrphan
Dec. 30, 1985 FDA GLAXOSMITHKLINE

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
Completed suicide 5068.60 9.51 3445 197598 141613 90285791
Toxicity to various agents 1272.28 9.51 2284 198759 285562 90141842
Intentional overdose 1010.60 9.51 1141 199902 92693 90334711
Overdose 862.19 9.51 1377 199666 156332 90271072
Seizure 688.23 9.51 1223 199820 151406 90275998
Suicidal ideation 631.86 9.51 799 200244 73056 90354348
Suspected suicide 627.34 9.51 341 200702 9227 90418177
Cardio-respiratory arrest 539.94 9.51 683 200360 62457 90364947
Generalised tonic-clonic seizure 523.63 9.51 507 200536 34396 90393008
Serotonin syndrome 495.86 9.51 511 200532 37376 90390028
Immunodeficiency 482.72 9.51 536 200507 42698 90384706
Food allergy 473.23 9.51 417 200626 25061 90402343
Temperature regulation disorder 471.40 9.51 331 200712 14248 90413156
Suicide attempt 451.52 9.51 687 200356 74712 90352692
Cardiac arrest 405.22 9.51 787 200256 104148 90323256
Hyperhidrosis 393.72 9.51 908 200135 135397 90292007
Anxiety 378.80 9.51 1524 199519 308248 90119156
Electrocardiogram QRS complex prolonged 348.26 9.51 212 200831 7136 90420268
Folliculitis 329.11 9.51 35 201008 204318 90223086
Depression 320.83 9.51 1419 199624 299182 90128222
Product substitution issue 319.04 9.51 287 200756 17721 90409683
Status epilepticus 315.21 9.51 291 200752 18583 90408821
Helicobacter infection 307.73 9.51 64 200979 226786 90200618
Agitation 287.22 9.51 526 200517 66572 90360832
Duodenal ulcer perforation 286.95 9.51 69 200974 221219 90206185
Respiratory arrest 285.73 9.51 361 200682 32950 90394454
Electrocardiogram QT prolonged 285.25 9.51 548 200495 71908 90355496
Sleep apnoea syndrome 285.02 9.51 352 200691 31395 90396009
Muscle injury 280.03 9.51 32 201011 176622 90250782
Product odour abnormal 273.24 9.51 110 200933 1461 90425943
Swelling 267.14 9.51 322 200721 418736 90008668
Pemphigus 258.02 9.51 208 200835 326656 90100748
Cardiogenic shock 255.43 9.51 293 200750 24175 90403229
Systemic lupus erythematosus 253.81 9.51 257 200786 361639 90065765
Sensitisation 246.80 9.51 139 200904 4036 90423368
Lower respiratory tract infection 243.45 9.51 126 200917 250533 90176871
Intentional product misuse 235.96 9.51 576 200467 89028 90338376
Polycystic ovaries 234.82 9.51 150 200893 5504 90421900
Asthma 234.34 9.51 1111 199932 241049 90186355
Glossodynia 231.96 9.51 223 200820 321556 90105848
Psoriasis 228.02 9.51 784 200259 146970 90280434
Mydriasis 224.99 9.51 218 200825 14794 90412610
Tremor 223.64 9.51 798 200245 152375 90275029
Rash erythematous 218.74 9.51 461 200582 64643 90362761
General physical health deterioration 213.63 9.51 285 200758 354830 90072574
Stomatitis 212.78 9.51 178 200865 274520 90152884
Irritability 212.07 9.51 324 200719 35338 90392066
Blister 209.13 9.51 156 200887 254842 90172562
Pericarditis 206.86 9.51 177 200866 269974 90157430
Irritable bowel syndrome 206.34 9.51 101 200942 207347 90220057
Neutropenia 205.44 9.51 122 200921 224782 90202622
Impaired healing 202.97 9.51 135 200908 234064 90193340
Foetal death 202.70 9.51 240 200803 20483 90406921
Ejection fraction 199.28 9.51 108 200935 2903 90424501
Hand deformity 197.07 9.51 220 200823 296142 90131262
Drug withdrawal syndrome 192.43 9.51 276 200767 28447 90398957
Sinus tachycardia 191.05 9.51 274 200769 28239 90399165
Arthropathy 190.26 9.51 325 200718 365917 90061487
Peripheral swelling 189.66 9.51 395 200648 412711 90014693
Areflexia 182.43 9.51 109 200934 3544 90423860
Rheumatic fever 181.13 9.51 57 200986 153064 90274340
Headache 167.61 9.51 2764 198279 859982 89567422
Myoclonus 163.21 9.51 207 200836 18961 90408443
Febrile neutropenia 162.21 9.51 74 200969 158275 90269129
C-reactive protein abnormal 160.74 9.51 42 201001 127387 90300017
Gastrointestinal disorder 158.41 9.51 202 200841 256485 90170919
Anaemia 154.69 9.51 346 200697 352456 90074948
Lip dry 153.35 9.51 21 201022 100934 90326470
Coeliac disease 149.96 9.51 316 200727 44294 90383110
Breast cancer stage III 145.22 9.51 11 201032 84436 90342968
Upper respiratory tract infection 144.47 9.51 616 200427 127702 90299702
Lung disorder 141.56 9.51 78 200965 149805 90277599
Facet joint syndrome 139.18 9.51 25 201018 98364 90329040
Type 2 diabetes mellitus 136.01 9.51 150 200893 203094 90224310
Ventricular tachycardia 133.73 9.51 215 200828 24493 90402911
Liver disorder 133.32 9.51 51 200992 121218 90306186
Fluid retention 131.98 9.51 463 200580 87628 90339776
Joint range of motion decreased 131.90 9.51 68 200975 135575 90291829
Pancytopenia 131.51 9.51 51 200992 120212 90307192
Liver injury 130.20 9.51 112 200931 170455 90256949
Feeling abnormal 130.05 9.51 722 200321 166513 90260891
Poisoning 129.03 9.51 164 200879 15053 90412351
Acute kidney injury 128.68 9.51 329 200714 320058 90107346
Sleep disorder due to general medical condition, insomnia type 127.41 9.51 63 200980 128631 90298773
Abdominal discomfort 126.73 9.51 586 200457 476742 89950662
Wound 124.10 9.51 308 200735 302672 90124732
Sympathomimetic effect 121.90 9.51 34 201009 124 90427280
Infarction 120.34 9.51 78 200965 2935 90424469
Swollen joint count increased 120.22 9.51 48 200995 111158 90316246
Alopecia 119.78 9.51 628 200415 494443 89932961
Wound infection 118.22 9.51 44 200999 106358 90321046
White blood cell count abnormal 118.18 9.51 112 200931 7392 90420012
Tardive dyskinesia 114.26 9.51 131 200912 10799 90416605
Dermatitis atopic 113.29 9.51 194 200849 23278 90404126
Synovitis 112.39 9.51 366 200677 329386 90098018
Nasopharyngitis 112.09 9.51 493 200550 406611 90020793
Mental status changes 111.03 9.51 281 200762 44398 90383006
Therapeutic response unexpected 107.13 9.51 182 200861 21698 90405706
Drug abuse 105.90 9.51 412 200631 81935 90345469
Musculoskeletal pain 103.31 9.51 137 200906 171114 90256290
Carpal tunnel syndrome 102.88 9.51 188 200855 23740 90403664
Malignant neoplasm progression 101.80 9.51 55 200988 106815 90320589
Withdrawal syndrome 100.70 9.51 180 200863 22344 90405060
Dyspnoea 99.92 9.51 1366 199677 879589 89547815
Anger 99.56 9.51 137 200906 13583 90413821
Rhinitis allergic 97.67 9.51 151 200892 16634 90410770
Anti-cyclic citrullinated peptide antibody positive 95.50 9.51 242 200801 236191 90191213
Disease progression 94.77 9.51 125 200918 156490 90270914
Peripheral venous disease 94.41 9.51 34 201009 83887 90343517
Brain death 93.62 9.51 75 200968 3946 90423458
Pupil fixed 92.22 9.51 58 200985 2070 90425334
Brugada syndrome 92.18 9.51 36 201007 439 90426965
Exposure via ingestion 91.95 9.51 63 200980 2604 90424800
Deep vein thrombosis postoperative 91.88 9.51 22 201021 70787 90356617
Drug hypersensitivity 91.74 9.51 1491 199552 462118 89965286
Gait inability 91.61 9.51 114 200929 146342 90281062
Ejection fraction abnormal 91.02 9.51 61 200982 2430 90424974
Maternal exposure during pregnancy 90.84 9.51 450 200593 359613 90067791
Grip strength decreased 90.60 9.51 46 200997 92530 90334874
Crying 90.09 9.51 185 200858 25460 90401944
Panic attack 90.05 9.51 188 200855 26177 90401227
Disturbance in attention 89.91 9.51 269 200774 46840 90380564
Cardiac failure 88.40 9.51 68 200975 109428 90317976
Live birth 87.39 9.51 33 201010 79074 90348330
Blood cholesterol increased 87.07 9.51 209 200834 207803 90219601
Brain injury 86.44 9.51 96 200947 7642 90419762
Discomfort 86.34 9.51 315 200728 274020 90153384
Foot deformity 86.31 9.51 310 200733 59341 90368063
Complication of device insertion 86.16 9.51 111 200932 10325 90417079
Pyrexia 85.67 9.51 995 200048 659490 89767914
Hallucinations, mixed 85.40 9.51 84 200959 5805 90421599
Hallucination, auditory 85.07 9.51 138 200905 15837 90411567
Nicotine dependence 84.71 9.51 43 201000 1007 90426397
Drug tolerance 83.74 9.51 146 200897 17770 90409634
Burning sensation 83.65 9.51 320 200723 63132 90364272
Oedema 83.23 9.51 202 200841 200093 90227311
Hypothyroidism 82.83 9.51 283 200760 52844 90374560
Platelet count decreased 82.17 9.51 110 200933 136859 90290545
Impulse-control disorder 81.52 9.51 41 201002 941 90426463
Product residue present 81.20 9.51 71 200972 4220 90423184
Asthma exercise induced 80.01 9.51 33 201010 468 90426936
Dissociation 79.69 9.51 86 200957 6629 90420775
Rheumatoid arthritis 78.84 9.51 1185 199858 361429 90065975
Nephrectomy 78.43 9.51 51 200992 1930 90425474
Renal disorder 76.86 9.51 221 200822 37638 90389766
Emotional distress 76.36 9.51 216 200827 36446 90390958
Diarrhoea 76.31 9.51 1548 199495 937642 89489762
Ill-defined disorder 75.62 9.51 188 200855 184703 90242701
Blepharospasm 74.39 9.51 16 201027 55429 90371975
Thermal burn 74.01 9.51 83 200960 6679 90420725
Blood test abnormal 73.43 9.51 151 200892 20801 90406603
Dislocation of vertebra 73.38 9.51 17 201026 55951 90371453
Tachycardia 73.18 9.51 599 200444 157074 90270330
Vertigo 73.09 9.51 328 200715 69483 90357921
Akathisia 72.94 9.51 106 200937 11053 90416351
Mental disorder 72.86 9.51 196 200847 32122 90395282
Factor V Leiden mutation 72.70 9.51 27 201016 284 90427120
Product dose omission issue 72.49 9.51 976 200067 290711 90136693
Pulseless electrical activity 72.18 9.51 94 200949 8838 90418566
Unresponsive to stimuli 72.11 9.51 217 200826 37904 90389500
Hyperreflexia 71.64 9.51 81 200962 6576 90420828
Bronchial neoplasm 71.61 9.51 31 201012 499 90426905
Adjustment disorder with depressed mood 71.00 9.51 19 201024 56734 90370670
Liver function test increased 69.39 9.51 52 200991 84803 90342601
Neutrophil count decreased 69.32 9.51 36 201007 71496 90355908
Atrial fibrillation 68.88 9.51 119 200924 133492 90293912
Corneal reflex decreased 68.25 9.51 26 201017 295 90427109
Loss of consciousness 67.92 9.51 538 200505 139700 90287704
Sciatica 67.59 9.51 75 200968 101307 90326097
Taste disorder 67.44 9.51 26 201017 61520 90365884
Mucosal inflammation 67.15 9.51 22 201021 57603 90369801
Hypercholesterolaemia 66.87 9.51 75 200968 100817 90326587
Product administration interrupted 66.64 9.51 108 200935 12384 90415020
Postictal state 65.52 9.51 40 201003 1353 90426051
X-ray abnormal 65.42 9.51 11 201032 45413 90381991
Bronchial haemorrhage 65.42 9.51 31 201012 622 90426782
Cholecystitis chronic 65.19 9.51 94 200949 9732 90417672
Contusion 65.03 9.51 311 200732 250905 90176499
Autoimmune disorder 64.09 9.51 46 200997 76698 90350706
Somnolence 63.73 9.51 727 200316 208357 90219047
Depressed mood 63.52 9.51 250 200793 49972 90377432
Pneumonia 62.96 9.51 1016 200027 637043 89790361
Postmortem blood drug level increased 62.74 9.51 31 201012 684 90426720
Bipolar disorder 62.63 9.51 88 200955 8897 90418507
Libido increased 62.03 9.51 42 201001 1702 90425702
Joint destruction 61.74 9.51 108 200935 13179 90414225
Confusional state 61.44 9.51 554 200489 385651 90041753
Sleep-related eating disorder 60.90 9.51 34 201009 970 90426434
Wheezing 60.89 9.51 296 200747 237784 90189620
Therapeutic product effect incomplete 60.82 9.51 678 200365 193218 90234186
Hostility 60.74 9.51 46 200997 2227 90425177
Onychomadesis 60.25 9.51 14 201029 45984 90381420
Asthenia 60.20 9.51 828 200215 532923 89894481
Bone marrow failure 58.98 9.51 3 201040 32218 90395186
Pre-existing condition improved 58.34 9.51 86 200957 9083 90418321
Psoriatic arthropathy 58.32 9.51 284 200759 228051 90199353
Arthralgia 58.23 9.51 1300 199743 777222 89650182
Joint swelling 57.38 9.51 779 200264 502521 89924883
Hyperkalaemia 56.83 9.51 37 201006 64927 90362477
Thinking abnormal 56.66 9.51 97 200946 11635 90415769
Urticaria 56.34 9.51 434 200609 312300 90115104
Infusion related reaction 55.84 9.51 623 200420 416157 90011247
Night sweats 55.77 9.51 127 200916 128639 90298765
Prescribed overdose 55.47 9.51 389 200654 97236 90330168
Cerebral venous thrombosis 55.44 9.51 44 200999 2284 90425120
Nasal turbinate hypertrophy 55.35 9.51 31 201012 890 90426514
Exposure during pregnancy 55.26 9.51 788 200255 237622 90189782
Major depression 55.23 9.51 88 200955 9947 90417457
Mood altered 54.79 9.51 119 200924 17025 90410379
Endometrial ablation 54.78 9.51 32 201011 997 90426407
Hallucination 54.76 9.51 290 200753 65669 90361735
Nightmare 54.35 9.51 137 200906 21588 90405816
C-reactive protein 54.17 9.51 4 201039 31363 90396041
Cholestasis 54.06 9.51 8 201035 36291 90391113
Sputum purulent 54.00 9.51 35 201008 1317 90426087
Nail disorder 53.94 9.51 32 201011 59035 90368369
Cardiac disorder 53.50 9.51 259 200784 56613 90370791
Nodule 53.41 9.51 155 200888 26531 90400873
Hepatic function abnormal 53.36 9.51 18 201025 46270 90381134
Encephalopathy 53.03 9.51 224 200819 46220 90381184
Affective disorder 52.36 9.51 75 200968 7718 90419686
Bruxism 51.99 9.51 56 200987 4307 90423097
Multiple organ dysfunction syndrome 51.97 9.51 45 200998 68291 90359113
Inflammation 51.70 9.51 212 200831 178380 90249024
Dyskinesia 51.27 9.51 188 200855 36346 90391058
Insomnia 51.22 9.51 1031 200012 332443 90094961
White blood cell count decreased 51.16 9.51 194 200849 166915 90260489
Oesophageal spasm 50.72 9.51 49 200994 3312 90424092
Sepsis 50.48 9.51 216 200827 179598 90247806
Lower limb fracture 50.25 9.51 69 200974 84944 90342460
Vision blurred 50.08 9.51 417 200626 109876 90317528
Rubber sensitivity 49.82 9.51 45 200998 2792 90424612
Hepatocellular injury 49.14 9.51 4 201039 28954 90398450
Multiple sclerosis relapse 49.05 9.51 238 200805 52067 90375337
Macular degeneration 48.86 9.51 12 201031 37958 90389446
Hypersexuality 48.65 9.51 25 201018 601 90426803
Choroidal effusion 48.63 9.51 27 201016 762 90426642
Pruritus 48.61 9.51 877 200166 540648 89886756
Restless legs syndrome 47.39 9.51 133 200910 22337 90405067
Sinusitis 45.87 9.51 513 200530 342575 90084829
Foreign body in reproductive tract 45.86 9.51 30 201013 1147 90426257
Clonus 45.67 9.51 60 200983 5690 90421714
Mobility decreased 45.60 9.51 347 200696 250387 90177017
Stress 45.46 9.51 323 200720 81072 90346332
Abdominal pain upper 45.44 9.51 495 200548 332179 90095225
Polyarthritis 45.15 9.51 115 200928 18235 90409169
Rectal haemorrhage 45.15 9.51 71 200972 82673 90344731
Endometriosis 44.75 9.51 62 200981 6186 90421218
Muscle twitching 44.11 9.51 136 200907 24066 90403338
Breast cancer stage II 43.87 9.51 12 201031 35322 90392082
Gastroenteritis viral 43.26 9.51 157 200886 30198 90397206
Decreased interest 43.03 9.51 51 200992 4356 90423048
Abnormal dreams 42.88 9.51 84 200959 11173 90416231
Sleep paralysis 42.79 9.51 26 201017 872 90426532
Haemoglobin decreased 42.77 9.51 199 200844 161757 90265647
Sexual dysfunction 42.68 9.51 53 200990 4751 90422653
Brain stem syndrome 42.51 9.51 24 201019 700 90426704
Multiple sclerosis 42.26 9.51 147 200896 27693 90399711
Chest pain 41.92 9.51 480 200563 319165 90108239
Mania 41.72 9.51 95 200948 14029 90413375
Bezoar 41.52 9.51 40 201003 2694 90424710
Sedation 41.50 9.51 214 200829 47957 90379447
Pineal gland cyst 41.05 9.51 16 201027 194 90427210
Sleep disorder due to a general medical condition 40.83 9.51 202 200841 44536 90382868
Bronchial disorder 40.61 9.51 31 201012 1519 90425885
Ankle arthroplasty 40.34 9.51 40 201003 2791 90424613
Decreased appetite 40.32 9.51 590 200453 375950 90051454
Product complaint 40.10 9.51 91 200952 13409 90413995
Hip arthroplasty 40.07 9.51 67 200976 76141 90351263
Secondary immunodeficiency 39.87 9.51 35 201008 2091 90425313
Anhedonia 39.60 9.51 82 200961 11349 90416055
Muscular weakness 39.49 9.51 282 200761 206384 90221020
C-reactive protein increased 39.47 9.51 238 200805 181151 90246253
Hypertension 39.46 9.51 1310 199733 456222 89971182
Rash maculo-papular 39.07 9.51 21 201022 40912 90386492
Delirium 38.95 9.51 111 200932 104248 90323156
Obsessive-compulsive disorder 38.91 9.51 49 200994 4455 90422949
Libido decreased 38.60 9.51 40 201003 2942 90424462
Soft tissue injury 38.35 9.51 34 201009 2058 90425346
Gastrointestinal haemorrhage 38.27 9.51 90 200953 90158 90337246
Pupillary reflex impaired 38.21 9.51 37 201006 2508 90424896
Hypoglycaemia 38.04 9.51 60 200983 69788 90357616
Dystonia 37.90 9.51 102 200941 16717 90410687
Post-traumatic stress disorder 37.75 9.51 60 200983 6768 90420636
Joint dislocation 37.68 9.51 197 200846 44385 90383019
Finger deformity 37.56 9.51 13 201030 32884 90394520
Feeling jittery 37.48 9.51 96 200947 15275 90412129
Renal impairment 37.27 9.51 115 200928 105306 90322098
Alcoholism 36.53 9.51 31 201012 1769 90425635
Intentional self-injury 36.27 9.51 145 200898 29189 90398215
Onychomycosis 35.93 9.51 19 201024 37357 90390047
Injury 35.93 9.51 273 200770 197076 90230328
Drug screen positive 35.89 9.51 43 201000 3714 90423690
Nausea 35.82 9.51 2892 198151 1107424 89319980
Choreoathetosis 35.78 9.51 20 201023 572 90426832
Drug interaction 35.48 9.51 833 200210 275620 90151784
Decreased immune responsiveness 35.43 9.51 67 200976 8681 90418723
Attention deficit hyperactivity disorder 35.32 9.51 45 200998 4139 90423265
Oesophageal pain 35.29 9.51 46 200997 4328 90423076
Persistent genital arousal disorder 35.25 9.51 21 201022 679 90426725
Anorgasmia 35.25 9.51 21 201022 679 90426725
Myelodysplastic syndrome 35.16 9.51 3 201040 20900 90406504
Gambling disorder 34.93 9.51 26 201017 1226 90426178
Nervousness 34.88 9.51 159 200884 33897 90393507
Mucosal dryness 34.88 9.51 39 201004 3128 90424276
Leukopenia 34.80 9.51 111 200932 100599 90326805
Treatment noncompliance 34.77 9.51 215 200828 51512 90375892
Feeling of despair 34.50 9.51 39 201004 3165 90424239
Sternal fracture 34.30 9.51 37 201006 2850 90424554
Reversible cerebral vasoconstriction syndrome 34.21 9.51 44 200999 4086 90423318
Interstitial lung disease 34.19 9.51 74 200969 76331 90351073
Hyponatraemia 34.13 9.51 166 200877 133372 90294032
Cervicogenic headache 33.98 9.51 14 201029 198 90427206
Angle closure glaucoma 33.74 9.51 36 201007 2739 90424665
Increased appetite 33.50 9.51 78 200965 11687 90415717
Orthostatic hypertension 33.29 9.51 19 201024 566 90426838
Ascites 33.29 9.51 34 201009 47706 90379698
Wrong technique in product usage process 33.23 9.51 272 200771 71299 90356105
Posterior reversible encephalopathy syndrome 33.09 9.51 5 201038 22334 90405070
Electroencephalogram abnormal 32.93 9.51 43 201000 4053 90423351
Hepatic failure 32.92 9.51 24 201019 39704 90387700
Binge eating 32.70 9.51 19 201024 586 90426818
Surgery 32.36 9.51 190 200853 44697 90382707
Tinnitus 32.08 9.51 184 200859 42918 90384486
Product label confusion 31.89 9.51 6 201037 22844 90404560
Tachyphrenia 31.82 9.51 28 201015 1678 90425726
Neoplasm progression 31.80 9.51 31 201012 44455 90382949
Foot operation 31.69 9.51 65 200978 8936 90418468
Galactorrhoea 31.44 9.51 45 200998 4627 90422777
Gamma-glutamyltransferase increased 31.36 9.51 23 201020 37929 90389475
Post-traumatic neck syndrome 31.25 9.51 33 201010 2481 90424923
Job dissatisfaction 31.13 9.51 10 201033 65 90427339
Creatinine renal clearance decreased 31.02 9.51 3 201040 18896 90408508
Drug titration error 30.79 9.51 24 201019 1213 90426191
Renal failure 30.58 9.51 168 200875 130839 90296565
Jaundice 30.57 9.51 17 201026 32500 90394904
Agranulocytosis 30.53 9.51 20 201023 34982 90392422
Hepatotoxicity 30.45 9.51 34 201009 45808 90381596
International normalised ratio increased 30.45 9.51 36 201007 47280 90380124
Economic problem 30.44 9.51 37 201006 3244 90424160
Hypomagnesaemia 30.15 9.51 21 201022 35567 90391837
Apathy 30.14 9.51 72 200971 10968 90416436
Knee arthroplasty 29.93 9.51 90 200953 83092 90344312
Abortion spontaneous 29.89 9.51 214 200829 53842 90373562
Vomiting 29.84 9.51 1437 199606 786856 89640548
Sleep disorder 29.76 9.51 288 200755 197742 90229662
Arthritis 29.68 9.51 529 200514 166786 90260618
Dyspepsia 29.43 9.51 289 200754 197871 90229533
Limb discomfort 29.33 9.51 164 200879 37896 90389508
Distributive shock 29.18 9.51 37 201006 3387 90424017
Automatism 29.12 9.51 10 201033 82 90427322
Female genital tract fistula 28.90 9.51 3 201040 17865 90409539
Hypotension 28.62 9.51 934 200109 324463 90102941
Parkinsonism 28.44 9.51 82 200961 13983 90413421
Blood pressure systolic increased 28.24 9.51 54 200989 58291 90369113
Somnambulism 28.13 9.51 50 200993 6178 90421226
Paranoia 27.81 9.51 77 200966 12831 90414573
Urine sodium increased 27.74 9.51 10 201033 96 90427308
Premature delivery 27.72 9.51 27 201016 38735 90388669
Hallucination, visual 27.64 9.51 113 200930 22979 90404425
Melaena 27.58 9.51 22 201021 34775 90392629
Dermatillomania 27.47 9.51 13 201030 260 90427144
Dizziness 27.43 9.51 1583 199460 587701 89839703
Rhinitis 27.32 9.51 79 200964 13493 90413911
Drug screen false positive 27.25 9.51 20 201023 923 90426481
Epistaxis 27.24 9.51 97 200946 85028 90342376
Osteonecrosis of jaw 27.09 9.51 28 201015 39075 90388329
Neuropathy peripheral 27.09 9.51 185 200858 136785 90290619
Bronchiectasis 26.95 9.51 8 201035 22322 90405082
Blood lactate dehydrogenase increased 26.72 9.51 12 201031 25920 90401484
Rhonchi 26.69 9.51 33 201010 2945 90424459
Wound complication 26.53 9.51 42 201001 4721 90422683
Osteoarthritis 26.40 9.51 292 200751 195438 90231966
Central nervous system necrosis 26.36 9.51 11 201032 161 90427243
Constipation 26.27 9.51 811 200232 279584 90147820
Anti-neutrophil cytoplasmic antibody positive vasculitis 26.20 9.51 38 201005 3955 90423449
Diabetes mellitus 26.17 9.51 239 200804 64636 90362768
Urine osmolarity increased 26.13 9.51 10 201033 115 90427289
Compulsive shopping 26.12 9.51 18 201025 751 90426653
Cerebral haemorrhage 25.92 9.51 23 201020 34499 90392905
Death 25.91 9.51 793 200250 455758 89971646
Dysphemia 25.89 9.51 33 201010 3037 90424367
Device placement issue 25.86 9.51 27 201016 2003 90425401
Peritonitis 25.80 9.51 6 201037 19699 90407705
Cytokine release syndrome 25.76 9.51 15 201028 27958 90399446
Metastases to liver 25.75 9.51 16 201027 28791 90398613
Gestational diabetes 25.71 9.51 66 200977 10516 90416888
Insurance issue 25.24 9.51 67 200976 10891 90416513
Myoglobinuria 25.19 9.51 14 201029 396 90427008
Accidental exposure to product by child 25.11 9.51 22 201021 1311 90426093
Drug dependence 25.06 9.51 130 200913 29197 90398207
Angina pectoris 24.98 9.51 30 201013 39130 90388274
Pneumonitis 24.96 9.51 37 201006 44133 90383271
Abnormal behaviour 24.95 9.51 108 200935 22520 90404884
Thalamic infarction 24.85 9.51 15 201028 497 90426907
Caput succedaneum 24.82 9.51 6 201037 10 90427394
Arrhythmia 24.82 9.51 170 200873 42162 90385242
Haemoglobin urine 24.76 9.51 10 201033 134 90427270
Retching 24.73 9.51 96 200947 19063 90408341
Loss of libido 24.63 9.51 22 201021 1345 90426059
Toxic skin eruption 24.63 9.51 3 201040 15771 90411633
Heart rate decreased 24.62 9.51 51 200992 53454 90373950
Inadequate analgesia 24.62 9.51 33 201010 3191 90424213
Porphyria acute 24.50 9.51 5 201038 17970 90409434
Drug-induced liver injury 24.42 9.51 110 200933 90208 90337196
Large intestine anastomosis 24.20 9.51 7 201036 30 90427374
Middle insomnia 24.18 9.51 87 200956 16664 90410740
Back pain 24.04 9.51 895 200148 316280 90111124
Blood bilirubin increased 24.00 9.51 37 201006 43433 90383971
Anticholinergic syndrome 23.95 9.51 30 201013 2713 90424691
Pregnancy 23.89 9.51 65 200978 61982 90365422
Euphoric mood 23.89 9.51 43 201000 5366 90422038
Urine amphetamine positive 23.69 9.51 8 201035 62 90427342
Biliary dyskinesia 23.61 9.51 29 201014 2570 90424834
Epilepsy 23.52 9.51 98 200945 82108 90345296
Emotional disorder 23.47 9.51 80 200963 14917 90412487
Adrenergic syndrome 23.25 9.51 9 201034 107 90427297
Polyneuropathy 23.22 9.51 7 201036 19334 90408070
Sensitivity to weather change 23.12 9.51 57 200986 8857 90418547
Sputum discoloured 23.01 9.51 98 200945 20293 90407111
Back injury 22.69 9.51 43 201000 46579 90380825
Device expulsion 22.68 9.51 162 200881 40724 90386680
Dysgraphia 22.65 9.51 34 201009 3649 90423755
Substance abuse 22.64 9.51 42 201001 5364 90422040
Erythema dyschromicum perstans 22.45 9.51 8 201035 74 90427330
Haemodynamic instability 22.36 9.51 67 200976 11672 90415732
Gallbladder disorder 22.21 9.51 95 200948 19708 90407696
Colitis 22.18 9.51 80 200963 69862 90357542
Accidental death 22.18 9.51 25 201018 2023 90425381
Symptom recurrence 22.18 9.51 35 201008 3924 90423480
Disseminated intravascular coagulation 22.14 9.51 10 201033 21528 90405876
Rash 22.13 9.51 1495 199548 794605 89632799
Impaired work ability 21.90 9.51 93 200950 19233 90408171
Device dislocation 21.88 9.51 132 200911 31350 90396054
Bipolar I disorder 21.84 9.51 25 201018 2057 90425347
Migraine without aura 21.79 9.51 16 201027 739 90426665
Haemophagocytic lymphohistiocytosis 21.70 9.51 4 201039 15455 90411949
Cardiotoxicity 21.69 9.51 65 200978 11324 90416080
Embedded device 21.68 9.51 36 201007 4212 90423192
Bipolar II disorder 21.64 9.51 13 201030 427 90426977
Oppositional defiant disorder 21.60 9.51 7 201036 47 90427357
Hunger 21.48 9.51 46 200997 6517 90420887
Mood swings 21.46 9.51 97 200946 20605 90406799
Myoclonic epilepsy 21.38 9.51 22 201021 1605 90425799
Dry mouth 21.24 9.51 284 200759 183775 90243629
Mass excision 21.22 9.51 12 201031 351 90427053
Supraventricular tachycardia 21.21 9.51 82 200961 16254 90411150
Neutropenic sepsis 20.98 9.51 7 201036 18123 90409281
Premature baby 20.97 9.51 15 201028 25062 90402342
Infusion site reaction 20.93 9.51 8 201035 19031 90408373
Bundle branch block bilateral 20.88 9.51 6 201037 25 90427379
Walking aid user 20.79 9.51 29 201014 35477 90391927
Maternal exposure timing unspecified 20.78 9.51 12 201031 22471 90404933
Self esteem decreased 20.68 9.51 16 201027 800 90426604
Toxic epidermal necrolysis 20.66 9.51 25 201018 32503 90394901
Narcolepsy 20.64 9.51 21 201022 1511 90425893
Adrenal insufficiency 20.51 9.51 125 200918 29796 90397608
Snoring 20.44 9.51 39 201004 5087 90422317
Hyperphagia 20.24 9.51 28 201015 2790 90424614
Cannabinoid hyperemesis syndrome 20.22 9.51 7 201036 59 90427345
Restlessness 20.09 9.51 142 200901 35578 90391826
Haematuria 20 9.51 29 201014 34908 90392496
Concussion 19.91 9.51 62 200981 11029 90416375
Depressive symptom 19.60 9.51 39 201004 5246 90422158
Hypoventilation 19.55 9.51 39 201004 5257 90422147
Lymphoedema 19.48 9.51 71 200972 13682 90413722
Uterine perforation 19.27 9.51 48 200995 7506 90419898
Metastases to bone 19.14 9.51 17 201026 25488 90401916
Red blood cell sedimentation rate abnormal 19.12 9.51 105 200938 24099 90403305
Sexually inappropriate behaviour 19.11 9.51 8 201035 118 90427286
Acute myeloid leukaemia 19.10 9.51 11 201032 20629 90406775
Medication error 18.97 9.51 110 200933 84542 90342862
Upper gastrointestinal haemorrhage 18.88 9.51 14 201029 22962 90404442
Haemangioma congenital 18.85 9.51 13 201030 543 90426861
Pericardial effusion 18.79 9.51 33 201010 36800 90390604
Tearfulness 18.61 9.51 36 201007 4744 90422660
Priapism 18.58 9.51 8 201035 127 90427277
Suicidal behaviour 18.57 9.51 27 201016 2817 90424587
Conduction disorder 18.48 9.51 21 201022 1714 90425690
Essential tremor 18.38 9.51 19 201024 1393 90426011
Exostosis 18.12 9.51 189 200854 52945 90374459
Drug specific antibody 18.10 9.51 25 201018 2487 90424917
Solar urticaria 18.10 9.51 7 201036 83 90427321
Posture abnormal 18.08 9.51 26 201017 2685 90424719
Eosinophilia 18.05 9.51 22 201021 28511 90398893
Oscillopsia 18.03 9.51 8 201035 137 90427267
Loss of personal independence in daily activities 18.02 9.51 412 200631 135693 90291711
Subcutaneous drug absorption impaired 17.98 9.51 4 201039 13541 90413863
Ankle fracture 17.90 9.51 91 200952 20279 90407125
Cardiomyopathy acute 17.89 9.51 10 201033 286 90427118
Lactic acidosis 17.87 9.51 55 200988 50408 90376996
Adverse reaction 17.67 9.51 24 201019 29688 90397716
Hangover 17.63 9.51 23 201020 2166 90425238
Injection site mass 17.57 9.51 96 200947 21994 90405410
Hypotonic urinary bladder 17.56 9.51 5 201038 20 90427384
Abnormal uterine bleeding 17.56 9.51 22 201021 1990 90425414
Shock haemorrhagic 17.56 9.51 3 201040 12242 90415162
Full blood count abnormal 17.48 9.51 140 200903 36457 90390947
Gastrointestinal sounds abnormal 17.42 9.51 34 201009 4509 90422895
Anaphylactic shock 17.37 9.51 27 201016 31590 90395814
Palmar-plantar erythrodysaesthesia syndrome 17.32 9.51 22 201021 28001 90399403
Dyspnoea exertional 17.25 9.51 92 200951 72196 90355208
Neurodermatitis 17.21 9.51 27 201016 3011 90424393
Forced expiratory volume decreased 17.08 9.51 39 201004 5769 90421635
Labelled drug-drug interaction issue 17.07 9.51 23 201020 2235 90425169
Bundle branch block left 16.95 9.51 47 200996 7838 90419566
Injection site pain 16.95 9.51 505 200538 173194 90254210
Product dose omission in error 16.91 9.51 90 200953 20413 90406991
Tic 16.84 9.51 21 201022 1890 90425514
Poor quality sleep 16.82 9.51 103 200940 24590 90402814
CSWS syndrome 16.66 9.51 5 201038 25 90427379
Exposure via breast milk 16.62 9.51 23 201020 2292 90425112
Compulsive sexual behaviour 16.61 9.51 6 201037 58 90427346
Hallucination, tactile 16.57 9.51 11 201032 431 90426973
Chronic sinusitis 16.54 9.51 17 201026 23785 90403619
Clostridium difficile colitis 16.47 9.51 21 201022 26685 90400719
Decorticate posture 16.47 9.51 10 201033 335 90427069
Nystagmus 16.46 9.51 44 200999 7183 90420221
General symptom 16.40 9.51 6 201037 14662 90412742
Generalised anxiety disorder 16.39 9.51 25 201018 2722 90424682
Yawning 16.38 9.51 16 201027 1096 90426308
Mental impairment 16.34 9.51 77 200966 16643 90410761
Device breakage 16.24 9.51 68 200975 13976 90413428
Tenosynovitis 16.21 9.51 6 201037 14561 90412843
Disability 16.20 9.51 42 201001 40703 90386701
Retinitis 16.18 9.51 143 200900 38315 90389089
Product solubility abnormal 16.03 9.51 15 201028 974 90426430
Haematochezia 15.97 9.51 92 200951 70821 90356583
Psychotic disorder 15.76 9.51 121 200922 31109 90396295
Thymoma 15.74 9.51 9 201034 269 90427135
Dysphoria 15.59 9.51 39 201004 6115 90421289
Liver function test abnormal 15.57 9.51 59 200984 50786 90376618
Metabolic syndrome 15.51 9.51 20 201023 1862 90425542
Speech disorder 15.48 9.51 162 200881 45423 90381981
Thrombocytopenia 15.39 9.51 349 200694 208376 90219028
Panic reaction 15.37 9.51 33 201010 4684 90422720
Colitis ulcerative 15.35 9.51 75 200968 60191 90367213
Cerebral infarction 15.30 9.51 22 201021 26574 90400830
Hypertransaminasaemia 15.28 9.51 8 201035 15817 90411587
Chorea 15.20 9.51 21 201022 2089 90425315
Balance disorder 15.16 9.51 301 200742 96779 90330625
Agraphia 15.13 9.51 5 201038 36 90427368
Poor personal hygiene 15.09 9.51 10 201033 391 90427013
Disorientation 15.08 9.51 157 200886 43957 90383447
Femur fracture 15.08 9.51 52 200991 46030 90381374
Treatment failure 15.07 9.51 537 200506 303391 90124013
Metabolic acidosis 14.93 9.51 189 200854 55487 90371917
Homicidal ideation 14.80 9.51 19 201024 1761 90425643
Hepatic encephalopathy 14.79 9.51 6 201037 13766 90413638
Hepatitis 14.76 9.51 94 200949 70645 90356759
Ventricular hypokinesia 14.76 9.51 35 201008 5306 90422098
Spinal operation 14.75 9.51 53 200990 10143 90417261
Illusion 14.67 9.51 16 201027 1248 90426156
Tension 14.67 9.51 28 201015 3654 90423750
Blood pressure diastolic decreased 14.65 9.51 23 201020 26803 90400601
Tooth fracture 14.56 9.51 61 200982 12539 90414865
Red blood cells urine 14.55 9.51 11 201032 531 90426873
Blood calcium decreased 14.55 9.51 28 201015 30154 90397250
Dysmenorrhoea 14.44 9.51 32 201011 4640 90422764
Breath sounds abnormal 14.41 9.51 70 200973 15316 90412088
Hypertensive crisis 14.40 9.51 11 201032 17773 90409631
Right ventricular systolic pressure decreased 14.35 9.51 5 201038 43 90427361
Memory impairment 14.31 9.51 554 200489 196690 90230714
Heavy menstrual bleeding 14.22 9.51 86 200957 20444 90406960
Complication of device removal 14.16 9.51 38 201005 6217 90421187
Q fever 14.15 9.51 7 201036 155 90427249
Metastases to lung 14.13 9.51 9 201034 15982 90411422
Haematemesis 14.01 9.51 34 201009 33692 90393712
Ulcer haemorrhage 13.96 9.51 23 201020 26298 90401106
Ventricular fibrillation 13.96 9.51 65 200978 13979 90413425
Dysgeusia 13.91 9.51 178 200865 52382 90375022
Second primary malignancy 13.91 9.51 3 201040 10375 90417029
Cytopenia 13.87 9.51 11 201032 17438 90409966
Abscess sterile 13.87 9.51 5 201038 48 90427356
Epstein-Barr virus infection 13.84 9.51 3 201040 10341 90417063
Rash vesicular 13.81 9.51 12 201031 18185 90409219
Eosinophil count abnormal 13.78 9.51 13 201030 853 90426551
Wound infection fungal 13.75 9.51 7 201036 165 90427239
Cystitis interstitial 13.71 9.51 18 201025 1706 90425698
Hypertonic bladder 13.69 9.51 30 201013 4318 90423086
Blood prolactin increased 13.68 9.51 27 201016 3610 90423794
Blood sodium increased 13.68 9.51 25 201018 3157 90424247
Migraine 13.64 9.51 534 200509 189858 90237546
Lupus-like syndrome 13.60 9.51 167 200876 48679 90378725
Tubulointerstitial nephritis 13.58 9.51 22 201021 25321 90402083
Pleural effusion 13.58 9.51 171 200872 111820 90315584
Colonoscopy 13.58 9.51 18 201025 1722 90425682
Musculoskeletal stiffness 13.57 9.51 529 200514 296003 90131401
Tongue biting 13.56 9.51 20 201023 2113 90425291
Lethargy 13.55 9.51 206 200837 62933 90364471
Hyperbilirubinaemia 13.52 9.51 7 201036 13929 90413475
Urinary incontinence 13.47 9.51 135 200908 37431 90389973
Infusion site scar 13.47 9.51 11 201032 595 90426809
Tumour lysis syndrome 13.45 9.51 4 201039 11148 90416256
Syncope 13.44 9.51 210 200833 132453 90294951
Product physical issue 13.44 9.51 35 201008 5625 90421779
Partial seizures 13.42 9.51 41 201002 7219 90420185
Coma 13.35 9.51 231 200812 72401 90355003
Food craving 13.32 9.51 19 201024 1948 90425456
Bacteraemia 13.27 9.51 18 201025 22282 90405122
Orgasmic sensation decreased 13.27 9.51 3 201040 3 90427401
Hyperglycaemia 13.23 9.51 63 200980 50907 90376497
Gangrene 13.20 9.51 6 201037 12870 90414534
Enterococcal infection 13.17 9.51 3 201040 9988 90417416
Product coating issue 13.10 9.51 6 201037 111 90427293
Haemorrhage 13.07 9.51 95 200948 69274 90358130
Right ventricular failure 13.03 9.51 14 201029 19191 90408213
Cortisol increased 12.99 9.51 10 201033 496 90426908
Oedema peripheral 12.94 9.51 455 200588 257460 90169944
Hypersomnia 12.94 9.51 87 200956 21444 90405960
Ear pain 12.92 9.51 75 200968 57627 90369777
COVID-19 12.91 9.51 477 200566 168366 90259038
Exposure to toxic agent 12.91 9.51 43 201000 7924 90419480
Sinus arrhythmia 12.89 9.51 16 201027 1433 90425971
Extra dose administered 12.86 9.51 47 200996 9071 90418333
Atrioventricular block complete 12.82 9.51 3 201040 9808 90417596
Inappropriate schedule of product administration 12.81 9.51 429 200614 149504 90277900
Road traffic accident 12.80 9.51 165 200878 107461 90319943
Metastases to central nervous system 12.80 9.51 12 201031 17530 90409874
Subacute cutaneous lupus erythematosus 12.77 9.51 26 201017 3556 90423848
Haemoptysis 12.75 9.51 35 201008 33285 90394119
Post procedural drainage 12.73 9.51 5 201038 62 90427342
Haemolytic anaemia 12.72 9.51 5 201038 11692 90415712
Stoma site ulcer 12.71 9.51 8 201035 286 90427118
Executive dysfunction 12.71 9.51 8 201035 286 90427118
Seronegative arthritis 12.70 9.51 13 201030 18221 90409183
Intentional dose omission 12.64 9.51 75 200968 17708 90409696
High density lipoprotein increased 12.64 9.51 15 201028 1283 90426121
Muscle rigidity 12.62 9.51 64 200979 14245 90413159
Wheelchair user 12.60 9.51 42 201001 7743 90419661
Pulmonary hypertension 12.60 9.51 50 200993 42473 90384931
Feeling of body temperature change 12.47 9.51 34 201009 5615 90421789
Ankle operation 12.44 9.51 16 201027 1486 90425918
Enuresis 12.43 9.51 25 201018 3389 90424015
Ventricular tachyarrhythmia 12.40 9.51 7 201036 204 90427200
Fear 12.40 9.51 71 200972 16551 90410853
Pelvic pain 12.39 9.51 67 200976 15290 90412114
Self-injurious ideation 12.32 9.51 24 201019 3179 90424225
Prostatic specific antigen abnormal 12.31 9.51 5 201038 68 90427336
Respiratory sinus arrhythmia magnitude 12.31 9.51 5 201038 68 90427336
Circulatory collapse 12.30 9.51 96 200947 24808 90402596
Impaired driving ability 12.29 9.51 32 201011 5141 90422263
Flat affect 12.29 9.51 17 201026 1694 90425710
Cardiac failure congestive 12.23 9.51 150 200893 98544 90328860
Carbon monoxide poisoning 12.22 9.51 7 201036 210 90427194
Frequent bowel movements 12.22 9.51 75 200968 56860 90370544
Rapid eye movements sleep abnormal 12.16 9.51 6 201037 132 90427272
Impulsive behaviour 12.14 9.51 17 201026 1713 90425691
Distractibility 12.12 9.51 10 201033 549 90426855
Dyspareunia 12.11 9.51 22 201021 2764 90424640
Blood potassium increased 12.10 9.51 17 201026 20732 90406672
Factitious disorder 12.08 9.51 6 201037 134 90427270
Respiratory tract infection 12.07 9.51 79 200964 58999 90368405
Pituitary hyperplasia 12.06 9.51 3 201040 6 90427398
Apnoea 12.01 9.51 47 200996 9367 90418037
Partner stress 12.01 9.51 9 201034 429 90426975
Radiculopathy 11.99 9.51 14 201029 18491 90408913
Perinatal depression 11.99 9.51 12 201031 847 90426557
Blood pressure diastolic abnormal 11.88 9.51 16 201027 19865 90407539
Impaired quality of life 11.86 9.51 90 200953 23054 90404350
Psychomotor hyperactivity 11.79 9.51 58 200985 12755 90414649
Vaginal odour 11.79 9.51 10 201033 570 90426834
Therapy cessation 11.77 9.51 128 200915 36233 90391171
Formication 11.76 9.51 30 201013 4761 90422643
Coagulopathy 11.76 9.51 21 201022 23268 90404136
Bankruptcy 11.74 9.51 4 201039 32 90427372
Cytokine storm 11.72 9.51 10 201033 575 90426829
Inflammatory marker increased 11.68 9.51 3 201040 9211 90418193
Angioedema 11.68 9.51 90 200953 64786 90362618
Serum sickness-like reaction 11.67 9.51 10 201033 578 90426826
Acute myocardial infarction 11.67 9.51 39 201004 34851 90392553
Bone pain 11.62 9.51 85 200958 61898 90365506
Respiratory acidosis 11.57 9.51 42 201001 8077 90419327
Off label use 11.52 9.51 2213 198830 1100039 89327365
Convulsive threshold lowered 11.51 9.51 9 201034 457 90426947
Respiratory failure 11.48 9.51 189 200854 118229 90309175
Depressed level of consciousness 11.47 9.51 226 200817 72558 90354846
Flushing 11.44 9.51 267 200776 88224 90339180
Malaise 11.41 9.51 1132 199911 584854 89842550
Jaundice cholestatic 11.41 9.51 4 201039 10039 90417365
Iron deficiency anaemia 11.36 9.51 22 201021 23640 90403764
Neck pain 11.34 9.51 181 200862 113782 90313622
Postmortem blood drug level abnormal 11.25 9.51 7 201036 245 90427159
Negative thoughts 11.22 9.51 13 201030 1084 90426320
Homeless 11.20 9.51 5 201038 87 90427317
Stress cardiomyopathy 11.15 9.51 8 201035 13347 90414057
Aggression 11.14 9.51 99 200944 26569 90400835
Staring 11.11 9.51 16 201027 1654 90425750
Lower gastrointestinal haemorrhage 11.08 9.51 3 201040 8889 90418515
Pseudomonas infection 11.05 9.51 10 201033 14855 90412549
Grimacing 10.97 9.51 9 201034 490 90426914
Intermenstrual bleeding 10.93 9.51 45 200998 9178 90418226
Red blood cell sedimentation rate increased 10.92 9.51 250 200793 82345 90345059
False positive investigation result 10.92 9.51 11 201032 782 90426622
Haematoma 10.89 9.51 47 200996 39001 90388403
Feeling drunk 10.87 9.51 29 201014 4729 90422675
Pancreatitis acute 10.67 9.51 36 201007 32079 90395325
Breast cancer stage I 10.65 9.51 4 201039 9620 90417784
Hypoaesthesia 10.64 9.51 579 200464 313631 90113773
Respiratory depression 10.63 9.51 65 200978 15510 90411894
Product counterfeit 10.63 9.51 6 201037 175 90427229
Bone erosion 10.62 9.51 171 200872 52850 90374554
Intestinal pseudo-obstruction 10.60 9.51 13 201030 1150 90426254
Granuloma 10.58 9.51 34 201009 6151 90421253
Gastrointestinal injury 10.57 9.51 11 201032 813 90426591
Menopause 10.55 9.51 23 201020 3298 90424106
Transfusion 10.53 9.51 14 201029 17474 90409930
Hepatic cirrhosis 10.51 9.51 198 200845 63055 90364349
Urinary retention 10.49 9.51 129 200914 37615 90389789
Blood creatinine increased 10.44 9.51 160 200883 101226 90326178
Overlap syndrome 10.43 9.51 3 201040 8545 90418859
Tri-iodothyronine free decreased 10.43 9.51 8 201035 395 90427009
Cushingoid 10.42 9.51 5 201038 10390 90417014
Cholelithiasis 10.39 9.51 169 200874 52337 90375067
Cerebral disorder 10.38 9.51 32 201011 5662 90421742
Blood pressure systolic abnormal 10.35 9.51 17 201026 19461 90407943
Chronic fatigue syndrome 10.32 9.51 15 201028 1564 90425840
Ischaemic stroke 10.31 9.51 21 201022 22145 90405259
Oral candidiasis 10.31 9.51 42 201001 35413 90391991
Breast cancer metastatic 10.30 9.51 11 201032 15121 90412283
Substance use 10.29 9.51 13 201030 1186 90426218
Rhinorrhoea 10.28 9.51 136 200907 88180 90339224
Erythema 10.28 9.51 614 200429 228632 90198772
Blood pressure fluctuation 10.26 9.51 71 200972 52342 90375062
Rales 10.23 9.51 12 201031 15815 90411589
Diabetes mellitus inadequate control 10.22 9.51 16 201027 18668 90408736
Compartment syndrome 10.22 9.51 21 201022 2891 90424513
Erythema induratum 10.21 9.51 6 201037 189 90427215
Electrocardiogram QRS complex shortened 10.18 9.51 9 201034 543 90426861
Dental pulp disorder 10.17 9.51 3 201040 14 90427390
Incorrect dose administered 10.16 9.51 238 200805 78692 90348712
Cardiac failure acute 10.16 9.51 7 201036 11922 90415482
Visual impairment 10.13 9.51 374 200669 131991 90295413
Nephropathy 10.12 9.51 44 200999 9191 90418213
Infusion site discomfort 10.10 9.51 16 201027 1800 90425604
Long QT syndrome congenital 10.09 9.51 5 201038 111 90427293
Metabolic surgery 10.09 9.51 15 201028 1596 90425808
Abnormal sleep-related event 10.06 9.51 11 201032 860 90426544
Pustular psoriasis 10.05 9.51 16 201027 18540 90408864
Juvenile melanoma benign 10.00 9.51 3 201040 15 90427389
Blood pressure orthostatic abnormal 10.00 9.51 3 201040 15 90427389
Peripheral sensory neuropathy 9.98 9.51 4 201039 9246 90418158
Gastric bypass 9.94 9.51 17 201026 2037 90425367
Device related infection 9.93 9.51 27 201016 25759 90401645
Initial insomnia 9.93 9.51 44 200999 9266 90418138
Pain in jaw 9.89 9.51 64 200979 47921 90379483
Gaze palsy 9.88 9.51 15 201028 1626 90425778
Haemorrhagic ovarian cyst 9.86 9.51 10 201033 717 90426687
Drug effect less than expected 9.83 9.51 33 201010 6105 90421299
Pain in extremity 9.81 9.51 863 200180 449666 89977738
Injection site abscess 9.78 9.51 14 201029 1440 90425964
Cold sweat 9.76 9.51 59 200984 14022 90413382
Lung assist device therapy 9.74 9.51 5 201038 120 90427284
Pulmonary renal syndrome 9.73 9.51 9 201034 576 90426828
Aspergillus infection 9.69 9.51 6 201037 10817 90416587
Pulmonary arterial hypertension 9.66 9.51 28 201015 26159 90401245
Pemphigoid 9.58 9.51 4 201039 9022 90418382
Cough 9.53 9.51 697 200346 368265 90059139

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
Completed suicide 2989.46 12.06 1891 67651 94574 42457219
Depression 1391.64 12.06 1271 68271 110092 42441701
Toxicity to various agents 900.39 12.06 1452 68090 227684 42324109
Serotonin syndrome 767.77 12.06 495 69047 25350 42526443
Drug interaction 739.18 12.06 1452 68090 265547 42286246
Intentional overdose 675.75 12.06 605 68937 50851 42500942
Suicidal ideation 598.42 12.06 549 68993 47612 42504181
Overdose 414.20 12.06 669 68873 104595 42447198
Psychiatric decompensation 411.20 12.06 179 69363 4043 42547750
Anxiety 404.65 12.06 707 68835 117853 42433940
Tearfulness 342.84 12.06 149 69393 3351 42548442
Seizure 342.08 12.06 664 68878 119897 42431896
Depression suicidal 337.08 12.06 144 69398 3101 42548692
Drug abuse 313.09 12.06 590 68952 104181 42447612
Electrocardiogram QRS complex prolonged 304.30 12.06 161 69381 5662 42546131
Depressive symptom 288.50 12.06 136 69406 3717 42548076
Generalised tonic-clonic seizure 282.17 12.06 277 69265 26102 42525691
Paranoia 278.63 12.06 210 69332 13816 42537977
Cardio-respiratory arrest 265.69 12.06 398 69144 58238 42493555
Psychotic disorder 251.53 12.06 273 69269 28935 42522858
Psychomotor skills impaired 236.04 12.06 131 69411 5073 42546720
Suicide attempt 201.80 12.06 308 69234 45792 42506001
Febrile neutropenia 197.36 12.06 33 69509 185670 42366123
Suspected suicide 191.99 12.06 122 69420 6077 42545716
Anaemia 188.60 12.06 112 69430 280166 42271627
Status epilepticus 184.36 12.06 173 69369 15405 42536388
Loss of personal independence in daily activities 170.78 12.06 298 69244 49518 42502275
Hyperreflexia 145.23 12.06 84 69458 3523 42548270
Thrombocytopenia 144.26 12.06 65 69477 190214 42361579
Acute kidney injury 136.99 12.06 244 69298 367093 42184700
Neutropenia 132.19 12.06 81 69461 199350 42352443
Tremor 131.61 12.06 402 69140 96527 42455266
Pyrexia 122.15 12.06 291 69251 393751 42158042
Sepsis 117.46 12.06 92 69450 199242 42352551
Electrocardiogram QT prolonged 114.27 12.06 246 69296 47699 42504094
Agitation 111.00 12.06 291 69251 64023 42487770
Insomnia 107.14 12.06 429 69113 117824 42433969
Malignant neoplasm progression 107.12 12.06 23 69519 108377 42443416
Cardiogenic shock 106.59 12.06 201 69341 35439 42516354
Disease progression 104.33 12.06 52 69490 143604 42408189
Depressed mood 103.35 12.06 157 69385 23227 42528566
Pneumonia 101.99 12.06 351 69191 421798 42129995
General physical health deterioration 95.30 12.06 65 69477 151181 42400612
Mania 91.48 12.06 99 69443 10448 42541345
Cardiac arrest 90.67 12.06 386 69156 108934 42442859
Pancytopenia 86.42 12.06 42 69500 117701 42434092
Respiratory arrest 85.85 12.06 161 69381 28263 42523530
Septic shock 85.52 12.06 22 69520 91650 42460143
Platelet count decreased 85.39 12.06 61 69481 138520 42413273
Poisoning 83.11 12.06 111 69431 14588 42537205
Product substitution issue 79.30 12.06 95 69447 11195 42540598
Interstitial lung disease 78.84 12.06 16 69526 78446 42473347
Sexual dysfunction 77.78 12.06 74 69468 6701 42545092
Psychomotor retardation 76.73 12.06 61 69481 4338 42547455
Substance abuse 76.20 12.06 83 69459 8822 42542971
Panic attack 76.04 12.06 92 69450 10953 42540840
Clonus 75.02 12.06 55 69487 3465 42548328
Off label use 72.56 12.06 680 68862 637655 41914138
Dissociation 71.30 12.06 55 69487 3743 42548050
Irritability 71.26 12.06 148 69394 27980 42523813
Distributive shock 69.61 12.06 46 69496 2450 42549343
Diarrhoea 69.00 12.06 455 69087 460394 42091399
Drug withdrawal syndrome 67.50 12.06 124 69418 21425 42530368
Major depression 65.88 12.06 61 69481 5337 42546456
Intentional self-injury 65.66 12.06 101 69441 15101 42536692
Hyperkalaemia 64.90 12.06 25 69517 80433 42471360
Sinus tachycardia 64.89 12.06 119 69423 20534 42531259
Mydriasis 61.93 12.06 74 69468 8696 42543097
Disturbance in attention 61.91 12.06 145 69397 29721 42522072
Cardiotoxicity 61.29 12.06 68 69474 7377 42544416
Dyspnoea 60.34 12.06 449 69093 442172 42109621
Tardive dyskinesia 60.06 12.06 65 69477 6859 42544934
Drug withdrawal syndrome neonatal 59.52 12.06 53 69489 4408 42547385
Exposure via ingestion 58.92 12.06 39 69503 2083 42549710
Therapeutic response unexpected 58.39 12.06 82 69460 11299 42540494
Memory impairment 57.84 12.06 197 69345 50025 42501768
Mucosal inflammation 56.50 12.06 7 69535 49367 42502426
Hallucination, visual 56.08 12.06 113 69429 20907 42530886
Product odour abnormal 55.38 12.06 28 69514 894 42550899
Renal impairment 55.20 12.06 59 69483 110169 42441624
Cardiac failure 54.85 12.06 56 69486 106800 42444993
Incorrect route of product administration 54.81 12.06 122 69420 24183 42527610
Anger 54.14 12.06 85 69457 12933 42538860
Erectile dysfunction 53.89 12.06 123 69419 24790 42527003
Postmortem blood drug level increased 53.71 12.06 23 69519 498 42551295
Drug reaction with eosinophilia and systemic symptoms 53.31 12.06 4 69538 42071 42509722
Myoclonus 53.20 12.06 98 69444 16967 42534826
Intentional product misuse 53.16 12.06 221 69321 61679 42490114
Electrocardiogram PR prolongation 53.02 12.06 28 69514 980 42550813
Bradyphrenia 52.07 12.06 53 69489 5209 42546584
Vein of Galen aneurysmal malformation 52.01 12.06 11 69531 11 42551782
Adjustment disorder 50.72 12.06 30 69512 1312 42550481
Feeling abnormal 49.97 12.06 236 69306 69550 42482243
Slow speech 49.94 12.06 33 69509 1757 42550036
Prescribed overdose 49.11 12.06 81 69461 12846 42538947
Hypokalaemia 47.62 12.06 29 69513 71692 42480101
Aggression 47.19 12.06 169 69373 43994 42507799
Maternal drugs affecting foetus 46.11 12.06 43 69499 3796 42547997
Abnormal behaviour 45.92 12.06 120 69422 26331 42525462
Leukopenia 45.88 12.06 33 69509 74713 42477080
Haemoglobin decreased 45.67 12.06 92 69450 132379 42419414
Pupil fixed 45.55 12.06 32 69510 1885 42549908
Unresponsive to stimuli 45.15 12.06 133 69409 31270 42520523
Infection 44.78 12.06 71 69471 111997 42439796
Pleural effusion 44.34 12.06 56 69486 97110 42454683
Autonomic nervous system imbalance 43.53 12.06 38 69504 3078 42548715
Rhinitis perennial 42.53 12.06 15 69527 188 42551605
Product residue present 42.44 12.06 36 69506 2805 42548988
Renal failure 41.35 12.06 110 69432 143616 42408177
Dysphoria 41.06 12.06 35 69507 2745 42549048
Drug dependence 40.67 12.06 122 69420 28972 42522821
White blood cell count decreased 40.38 12.06 74 69468 110322 42441471
Sedation 39.99 12.06 125 69417 30350 42521443
Libido decreased 39.30 12.06 45 69497 5053 42546740
Depersonalisation/derealisation disorder 39.17 12.06 20 69522 652 42551141
C-reactive protein increased 39.09 12.06 28 69514 63532 42488261
Cytokine release syndrome 39.07 12.06 12 69530 44515 42507278
Manic symptom 37.97 12.06 14 69528 201 42551592
Akathisia 37.72 12.06 64 69478 10387 42541406
Poor feeding infant 37.64 12.06 21 69521 821 42550972
Blood creatinine increased 37.40 12.06 77 69465 109926 42441867
Basilar artery occlusion 37.00 12.06 11 69531 76 42551717
Euphoric mood 36.89 12.06 49 69493 6404 42545389
Eosinophilia 36.83 12.06 5 69537 32894 42518899
Cholestasis 36.80 12.06 5 69537 32874 42518919
Withdrawal syndrome 36.55 12.06 77 69465 14698 42537095
Hallucination 36.55 12.06 188 69354 57319 42494474
Neonatal toxicity 36.35 12.06 9 69533 27 42551766
Dissociative disorder 36.29 12.06 19 69523 653 42551140
Restless legs syndrome 36.19 12.06 60 69482 9554 42542239
Loss of libido 36.13 12.06 34 69508 3036 42548757
Multiple organ dysfunction syndrome 35.52 12.06 65 69477 96970 42454823
Hepatic function abnormal 35.43 12.06 20 69522 51547 42500246
Tachycardia 35.37 12.06 284 69258 100803 42450990
Hyponatraemic coma 34.97 12.06 9 69533 33 42551760
Dermatitis atopic 34.67 12.06 68 69474 12336 42539457
Psychomotor hyperactivity 34.24 12.06 63 69479 10895 42540898
Respiratory failure 33.94 12.06 102 69440 128030 42423763
Lung disorder 33.78 12.06 18 69524 47905 42503888
Cytomegalovirus infection 33.69 12.06 6 69536 32300 42519493
Pulmonary embolism 33.30 12.06 93 69449 119519 42432274
Erythema 33.03 12.06 81 69461 108712 42443081
Abdominal pain 32.60 12.06 180 69362 190291 42361502
Feelings of worthlessness 32.40 12.06 14 69528 310 42551483
Mental status changes 32.04 12.06 145 69397 41970 42509823
Mood swings 31.78 12.06 54 69488 8772 42543021
Mood altered 31.47 12.06 60 69482 10658 42541135
Melaena 31.30 12.06 12 69530 38734 42513059
Encephalopathy 31.21 12.06 142 69400 41191 42510602
Brugada syndrome 30.81 12.06 20 69522 1033 42550760
Depressed level of consciousness 30.60 12.06 157 69385 47813 42503980
Transposition of the great vessels 30.52 12.06 15 69527 450 42551343
Malaise 30.34 12.06 212 69330 211944 42339849
Pneumocystis jirovecii pneumonia 30.25 12.06 3 69539 25178 42526615
Thinking abnormal 30.11 12.06 47 69495 7114 42544679
Delusion 29.95 12.06 71 69471 14663 42537130
Ascites 29.88 12.06 29 69513 56649 42495144
Pre-existing condition improved 29.60 12.06 30 69512 2933 42548860
Abnormal clotting factor 28.91 12.06 9 69533 74 42551719
Bone marrow failure 28.89 12.06 9 69533 33084 42518709
Oedema peripheral 28.89 12.06 119 69423 135957 42415836
Restlessness 28.78 12.06 109 69433 29140 42522653
Gastrointestinal haemorrhage 28.70 12.06 74 69468 97652 42454141
Encephalopathy neonatal 28.46 12.06 8 69534 44 42551749
Crying 28.34 12.06 43 69499 6351 42545442
Gamma-glutamyltransferase increased 28.08 12.06 9 69533 32488 42519305
Alcoholism 28.06 12.06 29 69513 2901 42548892
Liver disorder 27.78 12.06 15 69527 39629 42512164
Muscular dystrophy 27.75 12.06 10 69532 134 42551659
Screaming 27.71 12.06 24 69518 1923 42549870
Hallucinations, mixed 27.63 12.06 31 69511 3404 42548389
Lip squamous cell carcinoma 27.15 12.06 10 69532 143 42551650
Accidental poisoning 27.05 12.06 20 69522 1276 42550517
Feeling jittery 27.02 12.06 35 69507 4463 42547330
Cerebral haemorrhage 26.93 12.06 15 69527 38951 42512842
Emotional distress 26.90 12.06 72 69470 16021 42535772
Vomiting 26.87 12.06 323 69219 289400 42262393
Talipes 26.77 12.06 25 69517 2211 42549582
Hallucination, auditory 26.37 12.06 68 69474 14796 42536997
Disorientation 25.99 12.06 123 69419 36266 42515527
Hepatic cytolysis 25.88 12.06 6 69536 26838 42524955
Tumour lysis syndrome 25.80 12.06 3 69539 22228 42529565
Herbal interaction 25.71 12.06 13 69529 415 42551378
Pulmonary fibrosis 25.65 12.06 6 69536 26675 42525118
Delirium 25.64 12.06 160 69382 52359 42499434
Dyskinesia 25.29 12.06 95 69447 25295 42526498
Dysarthria 25.19 12.06 130 69412 39677 42512116
Rash maculo-papular 25.12 12.06 15 69527 37488 42514305
Stomatitis 25.11 12.06 27 69515 50302 42501491
Disseminated intravascular coagulation 25.01 12.06 5 69537 24789 42527004
Atrial fibrillation 24.93 12.06 130 69412 139463 42412330
Vasoplegia syndrome 24.93 12.06 26 69516 2629 42549164
Foetal exposure during pregnancy 24.27 12.06 146 69396 47165 42504628
Decreased interest 24.21 12.06 26 69516 2719 42549074
Gun shot wound 23.92 12.06 17 69525 1020 42550773
Toxic epidermal necrolysis 23.84 12.06 7 69535 26743 42525050
Persistent depressive disorder 23.83 12.06 13 69529 486 42551307
Orgasm abnormal 23.81 12.06 9 69533 139 42551654
Tubulointerstitial nephritis 23.51 12.06 11 69531 31537 42520256
Sleep apnoea syndrome 23.34 12.06 83 69459 21525 42530268
Dehydration 23.15 12.06 136 69406 141631 42410162
Oxygen saturation decreased 23.07 12.06 44 69498 64643 42487150
Road traffic accident 22.95 12.06 76 69466 19017 42532776
Decreased appetite 22.94 12.06 203 69339 192934 42358859
Jaundice 22.93 12.06 14 69528 34575 42517218
Mental disorder 22.78 12.06 73 69469 17956 42533837
Marital problem 22.76 12.06 7 69535 55 42551738
Neutrophil count decreased 22.74 12.06 43 69499 63372 42488421
Hypomania 22.55 12.06 24 69518 2484 42549309
Hyperhidrosis 22.37 12.06 236 69306 90276 42461517
Agranulocytosis 22.31 12.06 11 69531 30601 42521192
Apathy 22.19 12.06 45 69497 8361 42543432
Upper gastrointestinal haemorrhage 21.92 12.06 11 69531 30288 42521505
Bacterial infection 21.92 12.06 9 69533 27870 42523923
Pelvic abscess 21.53 12.06 16 69526 1029 42550764
Neonatal tachypnoea 21.45 12.06 11 69531 362 42551431
Pulse pressure decreased 21.40 12.06 9 69533 186 42551607
Electric shock sensation 21.35 12.06 12 69530 476 42551317
Anaphylactic shock 21.25 12.06 6 69536 23511 42528282
Obstructive airways disorder 21.14 12.06 7 69535 24752 42527041
Infusion related reaction 21.13 12.06 42 69500 60764 42491029
Hypoglycaemia 21.10 12.06 41 69501 59813 42491980
Tongue biting 20.97 12.06 16 69526 1071 42550722
Haematuria 20.89 12.06 39 69503 57760 42494033
Product complaint 20.77 12.06 36 69506 5941 42545852
Gastric hypomotility 20.51 12.06 9 69533 207 42551586
Myelodysplastic syndrome 20.19 12.06 6 69536 22739 42529054
COVID-19 20.13 12.06 109 69433 115839 42435954
Drug screen positive 20.06 12.06 29 69513 4102 42547691
Abulia 19.93 12.06 13 69529 677 42551116
Suicidal behaviour 19.90 12.06 18 69524 1528 42550265
Protein S decreased 19.68 12.06 7 69535 90 42551703
Hypomagnesaemia 19.64 12.06 11 69531 28477 42523316
Haemoptysis 19.63 12.06 28 69514 46139 42505654
Inadequate analgesia 19.40 12.06 25 69517 3172 42548621
Hallucination, tactile 19.28 12.06 12 69530 576 42551217
Neuropathy peripheral 19.24 12.06 93 69449 101760 42450033
Ideas of reference 18.89 12.06 6 69536 53 42551740
Joint swelling 18.84 12.06 53 69489 67969 42483824
Drug tolerance 18.83 12.06 25 69517 3265 42548528
Rheumatoid arthritis 18.79 12.06 25 69517 42415 42509378
Amnesia 18.78 12.06 94 69448 28343 42523450
Weight increased 18.60 12.06 263 69279 107720 42444073
Wrong technique in product usage process 18.44 12.06 126 69416 42509 42509284
Death 18.32 12.06 608 68934 470577 42081216
Bacteraemia 18.25 12.06 9 69533 25031 42526762
Colitis 18.12 12.06 30 69512 46542 42505251
Blood lactate dehydrogenase increased 18.08 12.06 10 69532 26071 42525722
Hepatocellular injury 18.04 12.06 8 69534 23670 42528123
Dry mouth 17.93 12.06 119 69423 39760 42512033
International normalised ratio increased 17.86 12.06 32 69510 48136 42503657
Nephropathy toxic 17.83 12.06 3 69539 16835 42534958
Acute myeloid leukaemia 17.80 12.06 7 69535 22249 42529544
Gastrooesophageal reflux disease 17.69 12.06 130 69412 44893 42506900
Obsessive-compulsive disorder 17.68 12.06 36 69506 6707 42545086
Blood testosterone decreased 17.66 12.06 30 69512 4872 42546921
Exposure via breast milk 17.65 12.06 21 69521 2456 42549337
Neoplasm progression 17.53 12.06 13 69529 28987 42522806
Urinary tract infection 17.42 12.06 93 69449 99191 42452602
Feeling of despair 17.42 12.06 15 69527 1193 42550600
Product administration interrupted 17.38 12.06 30 69512 4936 42546857
Urine amphetamine positive 17.28 12.06 5 69537 31 42551762
Homicidal ideation 17.19 12.06 22 69520 2772 42549021
Clonic convulsion 17.14 12.06 13 69529 862 42550931
Metastases to liver 17.09 12.06 3 69539 16323 42535470
Injection site mass 17.08 12.06 41 69501 8534 42543259
Atrial septal defect 17.01 12.06 39 69503 7880 42543913
Shock haemorrhagic 16.97 12.06 3 69539 16239 42535554
Lactic acidosis 16.84 12.06 30 69512 45231 42506562
Myasthenia gravis 16.82 12.06 3 69539 16134 42535659
Kidney enlargement 16.78 12.06 13 69529 890 42550903
Pericardial effusion 16.59 12.06 14 69528 29261 42522532
Lupus-like syndrome 16.59 12.06 23 69519 3131 42548662
Deep vein thrombosis 16.51 12.06 67 69475 76890 42474903
Epistaxis 16.42 12.06 55 69487 66771 42485022
Hypocalcaemia 16.41 12.06 15 69527 30158 42521635
Initial insomnia 16.32 12.06 26 69516 4004 42547789
Pain in extremity 16.29 12.06 162 69380 150442 42401351
Haemorrhage 16.18 12.06 48 69494 60515 42491278
Binge drinking 16.15 12.06 4 69538 12 42551781
Pneumonitis 16.11 12.06 27 69515 41691 42510102
Muscle twitching 16.08 12.06 49 69493 11731 42540062
Abnormal dreams 15.89 12.06 39 69503 8232 42543561
Gastric ulcer 15.88 12.06 5 69537 18257 42533536
Hostility 15.76 12.06 12 69530 801 42550992
Acute lung injury 15.71 12.06 16 69526 1573 42550220
Vision blurred 15.69 12.06 145 69397 53554 42498239
Loss of employment 15.61 12.06 10 69532 505 42551288
Lethargy 15.45 12.06 130 69412 46760 42505033
Candida infection 15.40 12.06 8 69534 21602 42530191
Postictal state 15.39 12.06 13 69529 1007 42550786
Tongue pruritus 15.37 12.06 5 69537 48 42551745
Bundle branch block right 15.34 12.06 38 69504 8068 42543725
Cutaneous lupus erythematosus 15.33 12.06 12 69530 834 42550959
Tinnitus 15.29 12.06 90 69452 28848 42522945
Somnambulism 15.18 12.06 23 69519 3392 42548401
Eczema 15.17 12.06 20 69522 34066 42517727
Obesity 15.10 12.06 60 69482 16399 42535394
Inability to afford medication 15.08 12.06 18 69524 2112 42549681
Pneumothorax 14.96 12.06 10 69532 23533 42528260
Clostridium difficile colitis 14.95 12.06 8 69534 21244 42530549
Lymphocyte count decreased 14.92 12.06 14 69528 27795 42523998
Hypoplastic right heart syndrome 14.89 12.06 4 69538 18 42551775
Dependence 14.81 12.06 15 69527 1465 42550328
Impulsive behaviour 14.77 12.06 19 69523 2406 42549387
Energy increased 14.75 12.06 15 69527 1472 42550321
Polyneuropathy 14.71 12.06 6 69536 18655 42533138
Oculocephalogyric reflex absent 14.55 12.06 4 69538 20 42551773
Prostate cancer 14.53 12.06 32 69510 44611 42507182
Peripheral swelling 14.51 12.06 87 69455 90183 42461610
Muscle rigidity 14.49 12.06 48 69494 12011 42539782
Persecutory delusion 14.44 12.06 23 69519 3541 42548252
Hunger 14.41 12.06 17 69525 1971 42549822
Enuresis 14.39 12.06 20 69522 2728 42549065
Alanine aminotransferase increased 14.32 12.06 85 69457 88321 42463472
Asthenia 14.26 12.06 349 69193 280444 42271349
Gambling disorder 14.24 12.06 16 69526 1760 42550033
Neuroleptic malignant syndrome 14.20 12.06 71 69471 21401 42530392
Product solubility abnormal 14.16 12.06 10 69532 594 42551199
Rash 14.13 12.06 344 69198 276610 42275183
Post-traumatic stress disorder 14.07 12.06 18 69524 2267 42549526
Blood bilirubin increased 13.99 12.06 30 69512 42222 42509571
Double inlet left ventricle 13.94 12.06 4 69538 24 42551769
Antidepressant drug level increased 13.80 12.06 7 69535 225 42551568
Treatment noncompliance 13.80 12.06 107 69435 37565 42514228
Nervousness 13.78 12.06 51 69491 13481 42538312
Device related infection 13.73 12.06 8 69534 20271 42531522
Balance disorder 13.59 12.06 128 69414 47517 42504276
Myocarditis 13.51 12.06 7 69535 18931 42532862
Nasal septal operation 13.48 12.06 5 69537 73 42551720
Lymphadenopathy 13.44 12.06 21 69521 33344 42518449
Injection site reaction 13.38 12.06 56 69486 15665 42536128
Ventricular hypoplasia 13.36 12.06 5 69537 75 42551718
Lentigo 13.35 12.06 11 69531 823 42550970
Hyponatraemia 13.23 12.06 104 69438 101358 42450435
Cytopenia 13.19 12.06 6 69536 17491 42534302
Product quality issue 13.17 12.06 61 69481 17821 42533972
Pupillary reflex impaired 13.17 12.06 15 69527 1674 42550119
Toxic optic neuropathy 13.17 12.06 12 69530 1028 42550765
Drug eruption 13.12 12.06 11 69531 23064 42528729
Ejaculation disorder 13.09 12.06 12 69530 1036 42550757
Inflammation 12.99 12.06 22 69520 33825 42517968
Vasculitis 12.83 12.06 7 69535 18387 42533406
Bipolar disorder 12.83 12.06 23 69519 3899 42547894
Respiratory distress 12.79 12.06 31 69511 41789 42510004
Pseudomonas infection 12.74 12.06 5 69537 15918 42535875
Multiple sclerosis 12.70 12.06 34 69508 7564 42544229
COVID-19 pneumonia 12.67 12.06 10 69532 21603 42530190
Bladder cancer 12.62 12.06 6 69536 17041 42534752
Reduced facial expression 12.61 12.06 14 69528 1519 42550274
Univentricular heart 12.53 12.06 4 69538 36 42551757
Local anaesthetic systemic toxicity 12.44 12.06 17 69525 2283 42549510
Lip pruritus 12.43 12.06 4 69538 37 42551756
Congenital aortic stenosis 12.37 12.06 5 69537 93 42551700
Emotional disorder 12.37 12.06 30 69512 6284 42545509
Blood triglycerides increased 12.29 12.06 55 69487 15841 42535952
Osteonecrosis of jaw 12.23 12.06 8 69534 19041 42532752
Chronic kidney disease 12.22 12.06 38 69504 47203 42504590
Hepatitis 12.17 12.06 16 69526 27284 42524509
Ischaemic stroke 12.16 12.06 11 69531 22222 42529571
Injection site pain 12.14 12.06 146 69396 57652 42494141
Adrenal insufficiency 12.08 12.06 8 69534 18916 42532877
Therapy partial responder 12.07 12.06 9 69533 20012 42531781

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
Completed suicide 7993.53 10.12 5324 214896 237057 110132022
Toxicity to various agents 2203.19 10.12 3645 216575 476910 109892169
Intentional overdose 2067.65 10.12 1873 218347 130628 110238451
Serotonin syndrome 1254.10 10.12 998 219222 58155 110310924
Overdose 1131.04 10.12 1820 218400 231974 110137105
Seizure 1045.49 10.12 1704 218516 219481 110149598
Electrocardiogram QRS complex prolonged 982.43 10.12 492 219728 12529 110356550
Suicidal ideation 914.03 10.12 1029 219191 92908 110276171
Depression 882.06 10.12 1949 218271 315386 110053693
Cardio-respiratory arrest 804.12 10.12 1070 219150 114766 110254313
Generalised tonic-clonic seizure 801.36 10.12 747 219473 53933 110315146
Suspected suicide 781.84 10.12 445 219775 14754 110354325
Anxiety 593.59 10.12 1769 218451 343309 110025770
Suicide attempt 559.20 10.12 848 219372 102546 110266533
Electrocardiogram QT prolonged 527.15 10.12 849 219371 108111 110260968
Status epilepticus 485.17 10.12 443 219777 31128 110337951
Cardiac arrest 454.66 10.12 1125 219095 195628 110173451
Temperature regulation disorder 442.72 10.12 291 219929 12535 110356544
Drug interaction 357.46 10.12 1949 218271 498234 109870845
Respiratory arrest 355.35 10.12 506 219714 57793 110311286
Food allergy 354.55 10.12 304 219916 19644 110349435
Febrile neutropenia 352.83 10.12 97 220123 316670 110052409
Agitation 347.43 10.12 724 219496 112327 110256752
Psychiatric decompensation 338.02 10.12 184 220036 5581 110363498
Anaemia 337.60 10.12 355 219865 546731 109822348
Drug abuse 331.02 10.12 937 219283 176474 110192605
Cardiogenic shock 319.47 10.12 477 219743 56861 110312218
Immunodeficiency 313.71 10.12 387 219833 38451 110330628
Neutropenia 313.67 10.12 178 220042 374442 109994637
Mydriasis 298.43 10.12 289 219931 21868 110347211
Acute kidney injury 293.22 10.12 510 219710 634920 109734159
Tearfulness 280.39 10.12 178 220042 7217 110361862
Depression suicidal 274.64 10.12 151 220069 4673 110364406
Tremor 273.91 10.12 956 219264 201276 110167803
Sinus tachycardia 260.63 10.12 379 219841 44114 110324965
Product substitution issue 259.67 10.12 273 219947 22788 110346291
Hyperhidrosis 242.12 10.12 872 219348 186426 110182653
Depressive symptom 238.40 10.12 169 220051 8245 110360834
General physical health deterioration 232.11 10.12 304 219916 424991 109944088
Sensitisation 231.00 10.12 128 220092 4023 110365056
Folliculitis 227.02 10.12 32 220188 167621 110201458
Polycystic ovaries 224.25 10.12 132 220088 4664 110364415
Paranoia 220.68 10.12 247 219973 22127 110346952
Pancytopenia 219.15 10.12 72 220148 209541 110159538
Myoclonus 213.84 10.12 295 219925 32703 110336376
Asthma 198.82 10.12 1005 219215 249286 110119793
Poisoning 195.86 10.12 265 219955 28840 110340239
Pyrexia 193.78 10.12 1026 219194 897239 109471840
Malignant neoplasm progression 191.41 10.12 55 220165 174512 110194567
Drug withdrawal syndrome 190.06 10.12 301 219919 37753 110331326
Foetal death 189.73 10.12 195 220025 15850 110353229
Psychomotor skills impaired 189.04 10.12 137 220083 6921 110362158
Ejection fraction 183.55 10.12 98 220122 2857 110366222
Disease progression 183.51 10.12 131 220089 243903 110125176
Helicobacter infection 180.64 10.12 68 220152 181809 110187270
Irritability 179.29 10.12 333 219887 47476 110321603
Muscle injury 179.08 10.12 32 220188 140775 110228304
Intentional product misuse 178.75 10.12 627 219593 132277 110236802
Psychotic disorder 169.19 10.12 337 219883 50600 110318479
Duodenal ulcer perforation 169 10.12 71 220149 177629 110191450
Psoriasis 167.64 10.12 636 219584 139357 110229722
Coeliac disease 167.23 10.12 305 219915 42882 110326197
Lung disorder 166.38 10.12 75 220145 179972 110189107
Sepsis 165.53 10.12 247 219973 327099 110041980
Areflexia 164.68 10.12 124 220096 6645 110362434
Lower respiratory tract infection 163.36 10.12 146 220074 242960 110126119
Platelet count decreased 162.66 10.12 132 220088 230311 110138768
Stomatitis 162.40 10.12 179 220041 270063 110099016
Sleep apnoea syndrome 159.60 10.12 288 219932 40159 110328920
Hyperreflexia 155.37 10.12 138 220082 9347 110359732
Liver disorder 144.94 10.12 51 220169 142192 110226887
Exposure via ingestion 144.82 10.12 101 220119 4799 110364280
C-reactive protein abnormal 143.77 10.12 40 220180 129655 110239424
Dyspnoea 142.79 10.12 1463 218757 1105409 109263670
Thrombocytopenia 142.33 10.12 301 219919 348584 110020495
Loss of personal independence in daily activities 139.81 10.12 631 219589 149389 110219690
Swelling 139.77 10.12 307 219913 350734 110018345
Tardive dyskinesia 139.24 10.12 153 220067 13426 110355653
Headache 136.74 10.12 2491 217729 879886 109489193
Dissociation 135.60 10.12 130 220090 9712 110359367
Peripheral swelling 135.46 10.12 386 219834 403648 109965431
Cardiac failure 134.25 10.12 106 220114 187520 110181559
Impaired healing 133.52 10.12 117 220103 196600 110172479
Lip dry 133.39 10.12 20 220200 100063 110269016
Pupil fixed 132.25 10.12 87 220133 3751 110365328
Mental status changes 131.21 10.12 391 219829 75731 110293348
Pneumonia 130.45 10.12 1118 219102 875596 109493483
Hyperkalaemia 127.93 10.12 55 220165 135741 110233338
Feeling abnormal 127.22 10.12 702 219518 180009 110189070
Blister 124.47 10.12 162 220058 227214 110141865
Ventricular tachycardia 123.95 10.12 294 219926 49715 110319364
Unresponsive to stimuli 123.85 10.12 342 219878 63448 110305631
Clonus 123.64 10.12 117 220103 8599 110360480
Tachycardia 122.47 10.12 822 219398 225823 110143256
Irritable bowel syndrome 121.02 10.12 90 220130 164125 110204954
Sympathomimetic effect 120.96 10.12 34 220186 147 110368932
Mucosal inflammation 117.68 10.12 24 220196 96117 110272962
Breast cancer stage III 117.32 10.12 11 220209 79106 110289973
Facet joint syndrome 116.81 10.12 25 220195 96803 110272276
Panic attack 116.65 10.12 208 220012 28732 110340347
Postmortem blood drug level increased 116.03 10.12 54 220166 1163 110367916
Gastrointestinal disorder 111.52 10.12 194 220026 241758 110127321
Carpal tunnel syndrome 110.37 10.12 177 220043 22433 110346646
Atrial fibrillation 108.71 10.12 181 220039 229461 110139618
Brugada syndrome 108.12 10.12 56 220164 1532 110367547
Complication of device insertion 107.38 10.12 109 220111 8729 110360350
Akathisia 104.93 10.12 149 220071 16964 110352115
Diarrhoea 104.89 10.12 1618 218602 1137887 109231192
Fluid retention 104.37 10.12 418 219802 93889 110275190
Rhinitis allergic 103.98 10.12 152 220068 17770 110351309
Rheumatic fever 102.82 10.12 58 220162 122521 110246558
Renal impairment 102.37 10.12 135 220085 188310 110180769
Withdrawal syndrome 102.27 10.12 206 220014 31174 110337905
Foot deformity 102.24 10.12 268 219952 48212 110320867
Pericarditis 101.60 10.12 175 220045 218939 110150140
Intentional self-injury 100.40 10.12 227 219993 37202 110331877
Rash erythematous 98.11 10.12 372 219848 81460 110287619
Interstitial lung disease 98.06 10.12 80 220140 139254 110229825
Infarction 97.10 10.12 82 220138 5187 110363892
Upper respiratory tract infection 97.02 10.12 517 219703 130811 110238268
Depressed mood 96.08 10.12 303 219917 60506 110308573
White blood cell count decreased 95.96 10.12 195 220025 229195 110139884
Neutrophil count decreased 94.77 10.12 62 220158 120879 110248200
Anger 94.43 10.12 150 220070 18857 110350222
Mania 93.67 10.12 157 220063 20639 110348440
Joint range of motion decreased 93.40 10.12 64 220156 121768 110247311
Dermatitis atopic 93.38 10.12 176 220044 25365 110343714
Cardiotoxicity 93.37 10.12 140 220080 16741 110352338
Emotional distress 92.63 10.12 246 219974 44601 110324478
Distributive shock 90.98 10.12 83 220137 5821 110363258
Multiple organ dysfunction syndrome 90.54 10.12 101 220119 151609 110217470
Cholestasis 90.47 10.12 11 220209 64507 110304572
Hepatic function abnormal 89.28 10.12 33 220187 89262 110279817
Major depression 87.63 10.12 107 220113 10514 110358565
Systemic lupus erythematosus 87.39 10.12 240 219980 254098 110114981
Asthenia 87.23 10.12 914 219306 688085 109680994
Crying 86.84 10.12 171 220049 25457 110343622
Hepatic cytolysis 86.22 10.12 6 220214 55047 110314032
Musculoskeletal pain 85.93 10.12 145 220075 182878 110186201
Cytomegalovirus infection 85.08 10.12 6 220214 54438 110314641
Disturbance in attention 83.76 10.12 293 219927 61702 110307377
Arthropathy 83.44 10.12 293 219927 287229 110081850
Haemoglobin decreased 80.84 10.12 241 219979 248486 110120593
Wound infection 80.39 10.12 46 220174 96419 110272660
Substance abuse 80.11 10.12 111 220109 12352 110356727
Hallucination 79.53 10.12 406 219814 101026 110268053
Mental disorder 79.32 10.12 212 220008 38579 110330500
Ejection fraction abnormal 78.93 10.12 61 220159 3399 110365680
Bone marrow failure 78.38 10.12 11 220209 57837 110311242
Joint dislocation 78.31 10.12 195 220025 33995 110335084
Product odour abnormal 77.79 10.12 45 220175 1538 110367541
Burning sensation 77.56 10.12 308 219912 68904 110300175
Nicotine dependence 76.70 10.12 42 220178 1289 110367790
Pemphigus 75.57 10.12 200 220020 214370 110154709
Peripheral venous disease 74.67 10.12 37 220183 84080 110284999
Bronchial neoplasm 74.50 10.12 31 220189 505 110368574
Liver injury 73.56 10.12 116 220104 150297 110218782
Sleep disorder due to general medical condition, insomnia type 72.67 10.12 62 220158 105581 110263498
Sexual dysfunction 72.11 10.12 87 220133 8443 110360636
Neuropathy peripheral 71.12 10.12 157 220063 179120 110189959
Hand deformity 70.80 10.12 212 220008 218294 110150785
Therapeutic product effect incomplete 70.73 10.12 719 219501 223086 110145993
Hypoglycaemia 70.70 10.12 76 220144 116028 110253051
Renal failure 70.45 10.12 224 219996 226350 110142729
Nephrectomy 70.15 10.12 51 220169 2589 110366490
Impulse-control disorder 69.03 10.12 47 220173 2147 110366932
Postictal state 69.00 10.12 49 220171 2397 110366682
Live birth 68.93 10.12 26 220194 69458 110299621
Off label use 68.65 10.12 2374 217846 1497811 108871268
Cytokine release syndrome 68.59 10.12 27 220193 70279 110298800
Sedation 68.59 10.12 298 219922 69385 110299694
Prescribed overdose 67.58 10.12 349 219871 87232 110281847
Hallucination, auditory 67.38 10.12 157 220063 26240 110342839
Corneal reflex decreased 66.96 10.12 29 220191 524 110368555
Hostility 66.95 10.12 50 220170 2646 110366433
Hallucination, visual 66.88 10.12 202 220018 39403 110329676
Rash maculo-papular 66.87 10.12 32 220188 74190 110294889
Glossodynia 66.59 10.12 223 219997 221781 110147298
Gastrointestinal haemorrhage 66.44 10.12 144 220076 165374 110203705
Pneumocystis jirovecii pneumonia 65.94 10.12 5 220215 42730 110326349
Septic shock 65.79 10.12 134 220086 157394 110211685
Drug hypersensitivity 65.25 10.12 1268 218952 452822 109916257
Leukopenia 65.22 10.12 123 220097 148668 110220411
Decreased appetite 64.82 10.12 620 219600 475226 109893853
Drug tolerance 64.03 10.12 117 220103 16468 110352611
Nasal turbinate hypertrophy 63.97 10.12 32 220188 812 110368267
Insomnia 63.91 10.12 1041 219179 359549 110009530
Rectal haemorrhage 63.90 10.12 87 220133 119746 110249333
Oedema 63.61 10.12 210 220010 209766 110159313
Psychomotor retardation 63.48 10.12 78 220142 7714 110361365
Hepatocellular injury 63.32 10.12 12 220208 50630 110318449
Pulseless electrical activity 63.17 10.12 117 220103 16640 110352439
Melaena 62.93 10.12 29 220191 68728 110300351
Libido increased 62.85 10.12 47 220173 2492 110366587
Thinking abnormal 62.54 10.12 110 220110 15030 110354049
Ascites 61.99 10.12 56 220164 92752 110276327
Abortion spontaneous 61.84 10.12 179 220041 34103 110334976
Blepharospasm 60.62 10.12 17 220203 54834 110314245
Endometrial ablation 60.46 10.12 32 220188 916 110368163
Swollen joint count increased 60.15 10.12 47 220173 83614 110285465
Oesophageal spasm 59.37 10.12 53 220167 3613 110365466
Deep vein thrombosis postoperative 59.12 10.12 22 220198 59269 110309810
Hyponatraemia 59.06 10.12 228 219992 217425 110151654
Type 2 diabetes mellitus 58.83 10.12 170 220050 177062 110192017
Muscle twitching 58.60 10.12 161 220059 29774 110339305
Rheumatoid arthritis 58.41 10.12 879 219341 298734 110070345
Vision blurred 58.10 10.12 448 219772 128574 110240505
Wound 57.74 10.12 255 219965 234182 110134897
Gamma-glutamyltransferase increased 57.46 10.12 25 220195 61284 110307795
Jaundice 57.38 10.12 23 220197 59213 110309866
Grip strength decreased 56.44 10.12 46 220174 80128 110288951
Nasopharyngitis 56.20 10.12 508 219712 393853 109975226
Restless legs syndrome 55.92 10.12 140 220080 24486 110344593
Onychomadesis 54.64 10.12 12 220208 45651 110323428
Therapeutic response unexpected 54.62 10.12 136 220084 23707 110345372
Brain injury 54.49 10.12 97 220123 13379 110355700
Cholecystitis chronic 54.28 10.12 80 220140 9420 110359659
Cerebral haemorrhage 54.11 10.12 31 220189 64937 110304142
Brain death 53.88 10.12 66 220154 6507 110362572
Rubber sensitivity 53.79 10.12 42 220178 2376 110366703
Libido decreased 52.59 10.12 62 220158 5873 110363206
Abnormal behaviour 52.29 10.12 184 220036 38855 110330224
Hallucinations, mixed 52.28 10.12 75 220145 8618 110360461
Pleural effusion 52.27 10.12 180 220040 177529 110191550
Agranulocytosis 52.11 10.12 29 220191 61731 110307348
Decreased interest 51.54 10.12 56 220164 4852 110364227
Hypomagnesaemia 51.44 10.12 28 220192 60342 110308737
Multiple sclerosis relapse 51.10 10.12 217 220003 50023 110319056
Muscular weakness 51.03 10.12 288 219932 248180 110120899
Haemophagocytic lymphohistiocytosis 50.73 10.12 3 220217 31556 110337523
Incorrect route of product administration 50.62 10.12 257 219963 63804 110305275
Taste disorder 50.57 10.12 34 220186 65353 110303726
Vertigo 50.49 10.12 321 219899 86549 110282530
Product residue present 50.44 10.12 50 220170 3891 110365188
Ankle arthroplasty 49.70 10.12 41 220179 2510 110366569
International normalised ratio increased 49.36 10.12 60 220160 86712 110282367
Eosinophilia 49.18 10.12 27 220193 57909 110311170
Sputum purulent 48.92 10.12 36 220184 1862 110367217
Ill-defined disorder 48.80 10.12 155 220065 156698 110212381
Liver function test increased 48.52 10.12 63 220157 88485 110280594
Inflammation 48.30 10.12 209 220011 193029 110176050
Hypokalaemia 48.29 10.12 193 220027 182255 110186824
Gait inability 48.09 10.12 127 220093 136249 110232830
Mood altered 48.00 10.12 121 220099 21254 110347825
Haematuria 47.63 10.12 57 220163 82948 110286131
Bronchopulmonary aspergillosis 47.51 10.12 3 220217 29860 110339219
C-reactive protein increased 47.27 10.12 248 219972 217671 110151408
Disseminated intravascular coagulation 47.13 10.12 12 220208 41274 110327805
Epistaxis 47.05 10.12 120 220100 130252 110238827
Bronchial haemorrhage 46.72 10.12 31 220189 1356 110367723
Myelodysplastic syndrome 46.61 10.12 9 220211 37475 110331604
Endometriosis 46.47 10.12 50 220170 4284 110364795
Sciatica 46.38 10.12 70 220150 92329 110276750
Sleep disorder due to a general medical condition 46.15 10.12 216 220004 51896 110317183
Pupillary reflex impaired 46.03 10.12 48 220172 3967 110365112
Polyneuropathy 46.03 10.12 5 220215 32007 110337072
Anti-cyclic citrullinated peptide antibody positive 45.99 10.12 196 220024 181788 110187291
Renal disorder 45.97 10.12 208 220012 49271 110319808
Bezoar 45.65 10.12 48 220172 4006 110365073
Pneumonitis 45.59 10.12 51 220169 76480 110292599
Blood creatinine increased 45.59 10.12 198 220022 182691 110186388
C-reactive protein 45.55 10.12 4 220216 30327 110338752
Product administration interrupted 45.30 10.12 81 220139 11211 110357868
Hypothyroidism 45.26 10.12 274 219946 72625 110296454
Anaphylactic shock 45.26 10.12 23 220197 51523 110317556
Nail disorder 44.98 10.12 30 220190 57905 110311174
Dystonia 44.88 10.12 133 220087 25672 110343407
Sleep paralysis 44.86 10.12 26 220194 892 110368187
Cerebral venous thrombosis 44.77 10.12 43 220177 3219 110365860
Posterior reversible encephalopathy syndrome 44.58 10.12 7 220213 33854 110335225
Upper gastrointestinal haemorrhage 44.51 10.12 22 220198 50074 110319005
Loss of libido 44.33 10.12 42 220178 3091 110365988
Haemoptysis 44.23 10.12 46 220174 71308 110297771
Blood test abnormal 43.93 10.12 141 220079 28413 110340666
Foreign body in reproductive tract 43.43 10.12 26 220194 948 110368131
Night sweats 43.38 10.12 130 220090 133853 110235226
Thrombotic microangiopathy 43.35 10.12 4 220216 29145 110339934
Product dose omission issue 43.32 10.12 890 219330 320892 110048187
Pruritus 43.26 10.12 857 219363 580703 109788376
Infusion related reaction 43.25 10.12 518 219702 380644 109988435
Wheezing 43.12 10.12 314 219906 254916 110114163
Vomiting 42.89 10.12 1435 218785 909240 109459839
Lupus-like syndrome 42.89 10.12 178 220042 40614 110328465
Brain stem syndrome 42.88 10.12 29 220191 1310 110367769
Osteonecrosis of jaw 42.80 10.12 21 220199 47996 110321083
Loss of consciousness 42.64 10.12 587 219633 195719 110173360
Dislocation of vertebra 42.31 10.12 17 220203 43704 110325375
Somnolence 42.14 10.12 829 219391 296620 110072459
Sleep-related eating disorder 42.04 10.12 25 220195 900 110368179
Bipolar disorder 41.91 10.12 69 220151 8938 110360141
Colitis 41.91 10.12 88 220132 102235 110266844
X-ray abnormal 41.78 10.12 12 220208 38105 110330974
Dyskinesia 41.78 10.12 208 220012 51238 110317841
Drug dependence 41.16 10.12 203 220017 49817 110319262
Neoplasm progression 40.77 10.12 41 220179 64554 110304525
Nephropathy toxic 40.26 10.12 4 220216 27474 110341605
Euphoric mood 40.23 10.12 67 220153 8760 110360319
Blood lactate dehydrogenase increased 40.11 10.12 19 220201 44315 110324764
Shock haemorrhagic 39.83 10.12 4 220216 27243 110341836
Autoimmune disorder 39.71 10.12 43 220177 65440 110303639
Hepatic failure 39.66 10.12 47 220173 68692 110300387
Autonomic nervous system imbalance 39.45 10.12 53 220167 5727 110363352
Bradyphrenia 39.42 10.12 78 220142 11650 110357429
Adjustment disorder with depressed mood 39.40 10.12 19 220201 43864 110325215
Feeling of despair 39.30 10.12 43 220177 3755 110365324
Tumour lysis syndrome 39.15 10.12 7 220213 30794 110338285
Neutropenic sepsis 39.05 10.12 7 220213 30739 110338340
Soft tissue injury 39.05 10.12 34 220186 2242 110366837
Respiratory failure 38.78 10.12 260 219960 215072 110154007
Blood cholesterol increased 38.58 10.12 213 220007 184572 110184507
Encephalopathy 38.48 10.12 285 219935 80770 110288309
Alcoholism 38.41 10.12 42 220178 3665 110365414
Tubulointerstitial nephritis 38.39 10.12 31 220189 54253 110314826
Device expulsion 38.32 10.12 142 220078 30749 110338330
Disorientation 37.93 10.12 256 219964 70415 110298664
Multiple sclerosis 37.82 10.12 125 220095 25573 110343506
Psychomotor hyperactivity 37.66 10.12 107 220113 20170 110348909
Contusion 37.56 10.12 291 219929 233070 110136009
Rhinitis perennial 37.54 10.12 15 220205 219 110368860
Metastases to liver 37.23 10.12 12 220208 35374 110333705
Depressed level of consciousness 37.03 10.12 364 219856 111914 110257165
Toxic epidermal necrolysis 36.97 10.12 35 220185 56692 110312387
Drug reaction with eosinophilia and systemic symptoms 36.74 10.12 67 220153 82028 110287051
Product complaint 36.65 10.12 84 220136 13888 110355191
Acute myeloid leukaemia 36.58 10.12 15 220205 38095 110330984
Oesophageal pain 36.53 10.12 48 220172 5077 110364002
Clostridium difficile colitis 36.30 10.12 21 220199 43757 110325322
Joint swelling 35.87 10.12 643 219577 442202 109926877
Obsessive-compulsive disorder 35.77 10.12 57 220163 7184 110361895
Lactic acidosis 35.40 10.12 83 220137 92728 110276351
Pericardial effusion 35.34 10.12 37 220183 57180 110311899
Inadequate analgesia 35.33 10.12 47 220173 5030 110364049
Persistent genital arousal disorder 35.32 10.12 20 220200 656 110368423
Mucosal dryness 35.26 10.12 43 220177 4220 110364859
Lower limb fracture 35.07 10.12 60 220160 75288 110293791
Malaise 34.87 10.12 1045 219175 670774 109698305
Decreased immune responsiveness 34.87 10.12 66 220154 9540 110359539
Urticaria 34.77 10.12 437 219783 318420 110050659
Reversible cerebral vasoconstriction syndrome 34.57 10.12 45 220175 4716 110364363
Nervousness 34.30 10.12 155 220065 36696 110332383
Cervicogenic headache 34.28 10.12 14 220206 217 110368862
Heart rate decreased 34.03 10.12 71 220149 82685 110286394
Restlessness 34.00 10.12 210 220010 56049 110313030
Exostosis 33.98 10.12 181 220039 45775 110323304
Dysphemia 33.84 10.12 41 220179 3996 110365083
Drug screen positive 33.81 10.12 52 220168 6358 110362721
Feeling jittery 33.75 10.12 84 220136 14638 110354441
Pineal gland cyst 33.48 10.12 14 220206 231 110368848
Post-traumatic neck syndrome 33.36 10.12 33 220187 2562 110366517
Affective disorder 33.35 10.12 71 220149 11170 110357909
Retinitis 33.16 10.12 140 220080 32187 110336892
Urine amphetamine positive 32.93 10.12 12 220208 134 110368945
Galactorrhoea 32.90 10.12 41 220179 4114 110364965
Abdominal discomfort 32.81 10.12 569 219651 393289 109975790
Peritonitis 32.68 10.12 12 220208 32595 110336484
Blood pressure systolic increased 32.64 10.12 73 220147 82918 110286161
Angina pectoris 32.43 10.12 46 220174 62249 110306830
Aspergillus infection 32.17 10.12 6 220214 25610 110343469
Anuria 32.12 10.12 5 220215 24336 110344743
Hypophosphataemia 31.95 10.12 13 220207 33169 110335910
Attention deficit hyperactivity disorder 31.91 10.12 42 220178 4449 110364630
Blood uric acid increased 31.90 10.12 3 220217 21526 110347553
Sternal fracture 31.66 10.12 36 220184 3280 110365799
Bacteraemia 31.52 10.12 23 220197 42367 110326712
Blood bilirubin increased 31.39 10.12 65 220155 75907 110293172
Post-traumatic stress disorder 31.32 10.12 51 220169 6545 110362534
Drug titration error 31.11 10.12 26 220194 1621 110367458
Bronchiectasis 30.98 10.12 17 220203 36476 110332603
Manic symptom 30.94 10.12 14 220206 282 110368797
Pneumothorax 30.60 10.12 16 220204 35269 110333810
Electrocardiogram PR prolongation 30.55 10.12 27 220193 1816 110367263
Slow speech 30.52 10.12 36 220184 3412 110365667
Abnormal dreams 30.44 10.12 74 220146 12706 110356373
Pre-existing condition improved 30.37 10.12 50 220170 6476 110362603
Anhedonia 30.22 10.12 83 220137 15345 110353734
Finger deformity 30.22 10.12 14 220206 33078 110336001
Hyperglycaemia 30.18 10.12 79 220141 85011 110284068
Synovitis 30.12 10.12 375 219845 273717 110095362
Haematochezia 30.06 10.12 123 220097 115401 110253678
Foot operation 30.03 10.12 53 220167 7260 110361819
Creatinine renal clearance decreased 29.90 10.12 4 220216 21811 110347268
Metastases to lung 29.84 10.12 5 220215 23058 110346021
Electroencephalogram abnormal 29.68 10.12 48 220172 6125 110362954
Feelings of worthlessness 29.60 10.12 17 220203 573 110368506
Joint destruction 28.93 10.12 66 220154 10877 110358202
Oedema peripheral 28.93 10.12 470 219750 328190 110040889
Device placement issue 28.89 10.12 26 220194 1791 110367288
Gastroenteritis viral 28.81 10.12 131 220089 31095 110337984
Pemphigoid 28.53 10.12 3 220217 19704 110349375
Apathy 28.53 10.12 84 220136 16155 110352924
Hyponatraemic coma 28.52 10.12 9 220211 62 110369017
Parkinsonism 28.37 10.12 103 220117 22084 110346995
Bronchial disorder 27.98 10.12 31 220189 2745 110366334
Hyperbilirubinaemia 27.97 10.12 13 220207 30658 110338421
Hallucination, tactile 27.86 10.12 20 220200 995 110368084
Joint stiffness 27.81 10.12 229 219991 67014 110302065
Increased appetite 27.79 10.12 79 220141 14898 110354181
Cardiac disorder 27.49 10.12 252 219968 76028 110293051
Treatment noncompliance 27.26 10.12 243 219977 72747 110296332
Prostate cancer 27.24 10.12 21 220199 37620 110331459
Accidental poisoning 27.21 10.12 29 220191 2458 110366621
Bladder cancer 27.16 10.12 4 220216 20288 110348791
Dizziness 27.15 10.12 1673 218547 696520 109672559
Cytopenia 27.10 10.12 13 220207 30103 110338976
Palmar-plantar erythrodysaesthesia syndrome 27.10 10.12 25 220195 41000 110328079
Bacterial infection 27.07 10.12 31 220189 46005 110323074
Product label confusion 27.05 10.12 6 220214 22671 110346408
Bruxism 27.03 10.12 41 220179 4953 110364126
Alopecia 26.94 10.12 538 219682 364215 110004864
Psoriatic arthropathy 26.90 10.12 256 219964 196505 110172574
Aggression 26.87 10.12 206 220014 59004 110310075
Job dissatisfaction 26.63 10.12 9 220211 79 110369000
Transplant rejection 26.44 10.12 8 220212 24559 110344520
Hepatotoxicity 26.40 10.12 54 220166 63346 110305733
Injection site mass 26.35 10.12 108 220112 24505 110344574
Syncope 26.23 10.12 267 219953 202269 110166810
Uterine perforation 26.09 10.12 48 220172 6792 110362287
Delusion 26.04 10.12 105 220115 23650 110345429
Breast cancer stage II 25.91 10.12 11 220209 27364 110341715
Hepatic encephalopathy 25.73 10.12 12 220208 28244 110340835
Tinnitus 25.48 10.12 207 220013 60333 110308746
Arthralgia 25.43 10.12 1281 218939 778351 109590728
Arthritis 25.40 10.12 472 219748 167114 110201965
Muscle rigidity 25.37 10.12 105 220115 23926 110345153
Orthostatic hypertension 25.27 10.12 19 220201 1016 110368063
Enterococcal infection 25.09 10.12 5 220215 20361 110348718
Anorgasmia 25.09 10.12 23 220197 1623 110367456
Screaming 24.91 10.12 39 220181 4842 110364237
Device dislocation 24.91 10.12 127 220093 31577 110337502
Haematemesis 24.91 10.12 50 220170 59058 110310021
Tongue biting 24.88 10.12 30 220190 2909 110366170
Sleep disorder 24.85 10.12 264 219956 198380 110170699
Orgasm abnormal 24.85 10.12 11 220209 210 110368869
Haemoglobin urine 24.84 10.12 10 220210 149 110368930
Hypotension 24.77 10.12 1278 218942 522571 109846508
Gambling disorder 24.77 10.12 26 220194 2165 110366914
Enterocolitis 24.76 10.12 4 220216 18945 110350134
Metastases to bone 24.68 10.12 16 220204 31356 110337723
Arrhythmia 24.64 10.12 229 219991 69346 110299733
Dermatitis bullous 24.55 10.12 3 220217 17526 110351553
Red blood cell sedimentation rate increased 24.44 10.12 251 219969 78051 110291028
Epstein-Barr virus infection 24.38 10.12 4 220216 18734 110350345
Homicidal ideation 24.36 10.12 33 220187 3594 110365485
Hypertransaminasaemia 24.18 10.12 9 220211 24246 110344833
Dissociative disorder 24.15 10.12 20 220200 1231 110367848
Sinusitis 23.94 10.12 431 219789 296257 110072822
Haemorrhage 23.93 10.12 120 220100 106572 110262507
Economic problem 23.91 10.12 35 220185 4096 110364983
Device related infection 23.91 10.12 26 220194 39493 110329586
Suicidal behaviour 23.77 10.12 32 220188 3465 110365614
Memory impairment 23.68 10.12 536 219684 196408 110172671
Respiratory distress 23.63 10.12 65 220155 68809 110300270
Erectile dysfunction 23.61 10.12 86 220134 18470 110350609
Cerebral infarction 23.47 10.12 42 220178 51796 110317283
Abdominal pain upper 23.41 10.12 523 219697 348588 110020491
Tachyphrenia 23.21 10.12 26 220194 2330 110366749
Dermatillomania 23.21 10.12 12 220208 327 110368752
Second primary malignancy 23.20 10.12 4 220216 18064 110351015
Migraine without aura 23.19 10.12 15 220205 628 110368451
Thermal burn 23.17 10.12 50 220170 7938 110361141
Hypertension 23.03 10.12 1239 218981 508845 109860234
Cough 22.96 10.12 722 219498 460919 109908160
Maternal exposure during pregnancy 22.93 10.12 363 219857 254520 110114559
Serum sickness-like reaction 22.72 10.12 16 220204 772 110368307
Drug screen false positive 22.58 10.12 20 220200 1349 110367730
Cannabinoid hyperemesis syndrome 22.48 10.12 8 220212 83 110368996
Hyperphosphataemia 22.46 10.12 3 220217 16378 110352701
Self esteem decreased 22.44 10.12 18 220202 1059 110368020
Blood phosphorus increased 22.39 10.12 3 220217 16337 110352742
Graft versus host disease 22.38 10.12 5 220215 18801 110350278
Porphyria acute 22.34 10.12 5 220215 18775 110350304
Chronic sinusitis 22.31 10.12 11 220209 25073 110344006
Erythema dyschromicum perstans 22.23 10.12 8 220212 86 110368993
Oliguria 22.13 10.12 5 220215 18652 110350427
Hepatitis 22.13 10.12 98 220122 89956 110279123
Pancreatitis acute 22.12 10.12 55 220165 60219 110308860
Respiratory tract infection 22.11 10.12 71 220149 71546 110297533
Dysphoria 21.91 10.12 43 220177 6385 110362694
Haemodynamic instability 21.85 10.12 97 220123 22791 110346288
Epilepsy 21.74 10.12 114 220106 100095 110268984
Sensitivity to weather change 21.72 10.12 56 220164 9972 110359107
Basilar artery occlusion 21.64 10.12 11 220209 289 110368790
Rhonchi 21.55 10.12 35 220185 4483 110364596
Onychomycosis 21.53 10.12 27 220193 38504 110330575
Pulmonary embolism 21.52 10.12 299 219921 214175 110154904
Symptom recurrence 21.45 10.12 36 220184 4736 110364343
Compulsive shopping 21.34 10.12 16 220204 852 110368227
Accidental exposure to product by child 21.33 10.12 29 220191 3169 110365910
Sudden death 21.24 10.12 11 220209 24384 110344695
Fatigue 21.22 10.12 2747 217473 1213211 109155868
Dyspnoea exertional 21.14 10.12 121 220099 103939 110265140
Partner stress 21.04 10.12 11 220209 307 110368772
Premature delivery 21.03 10.12 18 220202 30614 110338465
Binge eating 21.03 10.12 14 220206 616 110368463
Nightmare 20.99 10.12 141 220079 38722 110330357
Haematoma 20.96 10.12 54 220166 58422 110310657
Exposure during pregnancy 20.86 10.12 458 219762 166966 110202113
Bone erosion 20.86 10.12 161 220059 46210 110322869
Pseudomonas infection 20.85 10.12 15 220205 27838 110341241
Adverse reaction 20.80 10.12 17 220203 29577 110339502
Cardiac failure acute 20.76 10.12 11 220209 24067 110345012
Limb discomfort 20.74 10.12 146 220074 40708 110328371
Anti-neutrophil cytoplasmic antibody positive vasculitis 20.64 10.12 38 220182 5379 110363700
Lymphopenia 20.58 10.12 30 220190 40140 110328939
Muscular dystrophy 20.58 10.12 10 220210 238 110368841
Solar urticaria 20.52 10.12 8 220212 109 110368970
Bipolar I disorder 20.48 10.12 24 220196 2259 110366820
Weight decreased 20.48 10.12 744 219476 467313 109901766
Poor quality sleep 20.36 10.12 110 220110 27967 110341112
Exposure to toxic agent 20.24 10.12 64 220156 12794 110356285
Mental impairment 20.16 10.12 94 220126 22545 110346534
Acute lung injury 20.16 10.12 28 220192 3123 110365956
Gastric ulcer 20.15 10.12 30 220190 39797 110329282
Dysarthria 20.11 10.12 256 219964 83865 110285214
Anaphylactic reaction 20.08 10.12 139 220081 114161 110254918
Staphylococcal sepsis 20.06 10.12 5 220215 17449 110351630
Ischaemic stroke 20.00 10.12 32 220188 41231 110327848
Cardiac failure congestive 19.99 10.12 198 220022 150802 110218277
Sputum discoloured 19.94 10.12 109 220111 27836 110341243
Gun shot wound 19.87 10.12 17 220203 1095 110367984
Duodenal ulcer 19.86 10.12 7 220213 19507 110349572
Mood swings 19.79 10.12 94 220126 22718 110346361
Generalised anxiety disorder 19.76 10.12 26 220194 2753 110366326
Ventricular hypokinesia 19.69 10.12 58 220162 11156 110357923
Respiratory depression 19.68 10.12 120 220100 31881 110337198
Concussion 19.62 10.12 59 220161 11479 110357600
Electrolyte imbalance 19.62 10.12 27 220193 37001 110332078
Activated partial thromboplastin time prolonged 19.61 10.12 10 220210 22358 110346721
Adrenergic syndrome 19.53 10.12 10 220210 267 110368812
Impaired work ability 19.49 10.12 104 220116 26315 110342764
Secondary immunodeficiency 19.35 10.12 34 220186 4642 110364437
Biliary dyskinesia 19.34 10.12 24 220196 2397 110366682
Jaundice cholestatic 19.28 10.12 3 220217 14605 110354474
Partial seizures 19.27 10.12 58 220162 11291 110357788
Gallbladder disorder 19.23 10.12 88 220132 20941 110348138
Proctitis 19.17 10.12 5 220215 16922 110352157
Mass excision 19.15 10.12 11 220209 371 110368708
Atrioventricular block complete 19.12 10.12 8 220212 20074 110349005
Klebsiella infection 19.00 10.12 8 220212 20001 110349078
Emotional disorder 18.98 10.12 73 220147 16087 110352992
Balance disorder 18.96 10.12 332 219888 116228 110252851
Choreoathetosis 18.93 10.12 20 220200 1678 110367401
Marital problem 18.92 10.12 9 220211 204 110368875
Accidental death 18.91 10.12 35 220185 4974 110364105
Haemolytic anaemia 18.87 10.12 9 220211 20911 110348168
Poor personal hygiene 18.86 10.12 13 220207 606 110368473
Lymphoedema 18.83 10.12 69 220151 14860 110354219
Encephalitis 18.77 10.12 7 220213 18832 110350247
Staphylococcal bacteraemia 18.76 10.12 5 220215 16683 110352396
Herbal interaction 18.73 10.12 13 220207 613 110368466
Extra dose administered 18.66 10.12 60 220160 12099 110356980
Retching 18.62 10.12 92 220128 22590 110346489
Frequent bowel movements 18.58 10.12 76 220144 71314 110297765
Bipolar II disorder 18.56 10.12 12 220208 502 110368577
Colitis ulcerative 18.52 10.12 85 220135 77278 110291801
Rash 18.49 10.12 1396 218824 819568 109549511
Surgery 18.38 10.12 143 220077 41140 110327939
Automatism 18.37 10.12 9 220211 218 110368861
Urine sodium increased 18.37 10.12 9 220211 218 110368861
Complication of device removal 18.35 10.12 33 220187 4587 110364492
Hypercholesterolaemia 18.25 10.12 106 220114 90731 110278348
Liver function test abnormal 18.20 10.12 73 220147 68877 110300202
Angioedema 18.20 10.12 118 220102 98382 110270697
Blood pressure diastolic decreased 18.19 10.12 27 220193 35858 110333221
Cholangitis 18.17 10.12 5 220215 16330 110352749
Middle insomnia 18.16 10.12 85 220135 20417 110348662
Migraine 18.15 10.12 459 219761 171193 110197886
Blood calcium decreased 18.14 10.12 27 220193 35818 110333261
Dehydration 18.09 10.12 421 219799 279090 110089989
Tenosynovitis 18.08 10.12 5 220215 16278 110352801
Chronic fatigue syndrome 18.05 10.12 18 220202 1411 110367668
Blood pressure fluctuation 18.04 10.12 82 220138 74742 110294337
Musculoskeletal stiffness 17.96 10.12 422 219798 279400 110089679
Lip squamous cell carcinoma 17.94 10.12 10 220210 318 110368761
Oxygen saturation decreased 17.91 10.12 213 220007 156769 110212310
Drug specific antibody 17.90 10.12 25 220195 2803 110366276
Abnormal uterine bleeding 17.86 10.12 18 220202 1429 110367650
Infusion site scar 17.80 10.12 11 220209 425 110368654
Acute myocardial infarction 17.79 10.12 96 220124 83681 110285398
Large intestine anastomosis 17.72 10.12 7 220213 99 110368980
Hyperammonaemia 17.72 10.12 3 220217 13729 110355350
Impulsive behaviour 17.63 10.12 27 220193 3288 110365791
Central nervous system necrosis 17.55 10.12 11 220209 436 110368643
Confusional state 17.47 10.12 759 219461 467921 109901158
Diffuse large B-cell lymphoma 17.43 10.12 5 220215 15893 110353186
Schizoaffective disorder 17.33 10.12 26 220194 3110 110365969
Compartment syndrome 17.15 10.12 37 220183 5873 110363206
Dependence 17.08 10.12 24 220196 2705 110366374
Endocarditis 17.08 10.12 3 220217 13368 110355711
Hyperuricaemia 17.02 10.12 4 220216 14527 110354552
Decorticate posture 16.97 10.12 10 220210 354 110368725
Peripheral sensory neuropathy 16.95 10.12 6 220214 16674 110352405
Appendicitis 16.92 10.12 19 220201 28445 110340634
Inflammatory marker increased 16.92 10.12 4 220216 14465 110354614
Vasoplegia syndrome 16.89 10.12 35 220185 5404 110363675
Heavy menstrual bleeding 16.88 10.12 71 220149 16294 110352785
Abnormal clotting factor 16.87 10.12 8 220212 180 110368899
Abdominal pain 16.87 10.12 842 219378 512147 109856932
Erysipelas 16.70 10.12 3 220217 13155 110355924
Nausea 16.69 10.12 2751 217469 1232939 109136140
Initial insomnia 16.62 10.12 52 220168 10337 110358742
Antidepressant drug level increased 16.59 10.12 12 220208 604 110368475
Rales 16.43 10.12 15 220205 24724 110344355
Injection site induration 16.42 10.12 55 220165 11328 110357751
Gangrene 16.40 10.12 6 220214 16335 110352744
Plasma cell myeloma 16.38 10.12 67 220153 62869 110306210
Urinary tract infection 16.28 10.12 510 219710 325772 110043307
Anticholinergic syndrome 16.28 10.12 30 220190 4250 110364829
Embedded device 16.27 10.12 29 220191 4004 110365075
Lymphoma 16.27 10.12 10 220210 20161 110348918
Laryngitis 16.25 10.12 142 220078 42269 110326810
Nodule 16.21 10.12 116 220104 32515 110336564
Pregnancy 16.20 10.12 50 220170 51017 110318062
Postmortem blood drug level abnormal 16.18 10.12 12 220208 628 110368451
Wheelchair user 16.17 10.12 43 220177 7799 110361280
Mobility decreased 16.10 10.12 355 219865 237067 110132012
Urine osmolarity increased 16.01 10.12 9 220211 291 110368788
Ankle fracture 16.00 10.12 80 220140 19739 110349340
Cardiomyopathy acute 15.96 10.12 10 220210 396 110368683
Insurance issue 15.96 10.12 52 220168 10560 110358519
Clostridium difficile infection 15.87 10.12 52 220168 52077 110317002
Cataract 15.84 10.12 93 220127 79392 110289687
Cardiac failure chronic 15.79 10.12 4 220216 13807 110355272
Persistent depressive disorder 15.77 10.12 17 220203 1460 110367619
Lethargy 15.75 10.12 268 219952 93308 110275771
Pain in extremity 15.73 10.12 801 219419 486317 109882762
Ventricular arrhythmia 15.69 10.12 50 220170 10037 110359042
Corneal light reflex test abnormal 15.66 10.12 3 220217 0 110369079
Gastrooesophageal reflux disease 15.57 10.12 469 219751 179507 110189572
Thymoma 15.56 10.12 10 220210 414 110368665
Oral candidiasis 15.53 10.12 42 220178 44718 110324361
Metabolic acidosis 15.48 10.12 282 219938 99462 110269617
Chest pain 15.40 10.12 603 219617 375772 109993307
Infusion site reaction 15.36 10.12 8 220212 17674 110351405
Drug resistance 15.31 10.12 59 220161 56315 110312764
Supraventricular tachycardia 15.29 10.12 92 220128 24330 110344749
Coagulopathy 15.27 10.12 37 220183 40874 110328205
Drug-induced liver injury 15.24 10.12 159 220061 119908 110249171
Candida infection 15.24 10.12 47 220173 47962 110321117
Pulse pressure decreased 15.22 10.12 10 220210 430 110368649
Subdural haematoma 15.22 10.12 31 220189 36423 110332656
Thalamic infarction 15.21 10.12 16 220204 1336 110367743
CSWS syndrome 15.20 10.12 5 220215 40 110369039
Flushing 15.18 10.12 293 219927 104443 110264636
Escherichia infection 15.16 10.12 15 220205 23801 110345278
COVID-19 pneumonia 15.16 10.12 32 220188 37111 110331968
Pulmonary arterial hypertension 15.09 10.12 26 220194 32542 110336537
Respiratory acidosis 15.06 10.12 61 220159 13765 110355314
Acute respiratory failure 15.02 10.12 88 220132 75172 110293907
Blood potassium increased 15.00 10.12 27 220193 33222 110335857
Protein S decreased 14.99 10.12 7 220213 152 110368927
Bundle branch block left 14.96 10.12 58 220162 12830 110356249
Back pain 14.95 10.12 892 219328 370104 109998975
Wound infection fungal 14.93 10.12 8 220212 235 110368844
Conduction disorder 14.89 10.12 28 220192 4027 110365052
Pulmonary hypertension 14.87 10.12 58 220162 55162 110313917
Maternal exposure timing unspecified 14.86 10.12 12 220208 21001 110348078
Clonic convulsion 14.83 10.12 17 220203 1563 110367516
Hypogammaglobulinaemia 14.79 10.12 11 220209 20065 110349014
Joint effusion 14.70 10.12 12 220208 20893 110348186
Anterograde amnesia 14.70 10.12 13 220207 875 110368204
Vaginal odour 14.68 10.12 10 220210 457 110368622
Injection site abscess 14.63 10.12 19 220201 1987 110367092
Illusion 14.62 10.12 19 220201 1988 110367091
Speech disorder 14.56 10.12 187 220033 61382 110307697
Macular degeneration 14.54 10.12 13 220207 21646 110347433
Injection site pain 14.42 10.12 460 219760 177462 110191617
Dyspareunia 14.41 10.12 20 220200 2229 110366850
Face oedema 14.37 10.12 28 220192 33441 110335638
Acute pulmonary oedema 14.31 10.12 8 220212 16988 110352091
Rhinovirus infection 14.31 10.12 3 220217 11786 110357293
Metastases to lymph nodes 14.29 10.12 6 220214 15026 110354053
End stage renal disease 14.28 10.12 13 220207 21460 110347619
Wrong technique in product usage process 14.28 10.12 249 219971 87099 110281980
Death 14.24 10.12 1198 219022 697671 109671408
Oculocephalogyric reflex absent 14.22 10.12 5 220215 50 110369029
Immunosuppressant drug level increased 14.19 10.12 3 220217 11721 110357358
Hepatic cirrhosis 14.18 10.12 201 220019 67425 110301654
Nystagmus 14.18 10.12 53 220167 11524 110357555
Vaginal haemorrhage 14.16 10.12 92 220128 24982 110344097
Pallor 14.14 10.12 61 220159 56406 110312673
Bronchospasm 14.14 10.12 24 220196 30215 110338864
Somnambulism 14.11 10.12 36 220184 6369 110362710
Drug eruption 14.04 10.12 57 220163 53602 110315477
Feeling guilty 14.00 10.12 13 220207 933 110368146
Pathogen resistance 13.92 10.12 9 220211 17663 110351416
Wound complication 13.90 10.12 35 220185 6142 110362937
Rapid eye movements sleep abnormal 13.87 10.12 8 220212 272 110368807
Abulia 13.82 10.12 15 220205 1298 110367781
Lower gastrointestinal haemorrhage 13.78 10.12 10 220210 18476 110350603
Thrombosis 13.75 10.12 144 220076 108518 110260561
Hypertensive crisis 13.70 10.12 17 220203 24355 110344724
Heparin-induced thrombocytopenia 13.67 10.12 3 220217 11421 110357658
Pituitary hyperplasia 13.59 10.12 3 220217 3 110369076
Blood lactic acid increased 13.58 10.12 65 220155 15756 110353323
Red blood cells urine 13.57 10.12 11 220209 657 110368422
Hypomania 13.57 10.12 48 220172 10162 110358917
Hypoalbuminaemia 13.55 10.12 23 220197 28951 110340128
Visual impairment 13.49 10.12 357 219863 134071 110235008
Enuresis 13.48 10.12 27 220193 4069 110365010
Colon cancer 13.47 10.12 8 220212 16435 110352644
Sinus arrhythmia 13.46 10.12 19 220201 2151 110366928
Gastrointestinal sounds abnormal 13.44 10.12 34 220186 5984 110363095
Bundle branch block bilateral 13.44 10.12 6 220214 117 110368962
Pulmonary fibrosis 13.42 10.12 134 220086 101908 110267171
Hunger 13.41 10.12 36 220184 6568 110362511
Petechiae 13.39 10.12 16 220204 23301 110345778
Stress 13.38 10.12 289 219931 105059 110264020
Right ventricular systolic pressure decreased 13.34 10.12 6 220214 119 110368960
Gross motor delay 13.30 10.12 7 220213 198 110368881
Binge drinking 13.29 10.12 4 220216 23 110369056
Hypervolaemia 13.28 10.12 52 220168 49408 110319671
Alanine aminotransferase increased 13.27 10.12 272 219948 183501 110185578
Agraphia 13.25 10.12 5 220215 62 110369017
Gastric hypomotility 13.23 10.12 8 220212 297 110368782
Myoclonic epilepsy 13.04 10.12 21 220199 2670 110366409
Hyperthyroidism 12.98 10.12 24 220196 29237 110339842
Hip arthroplasty 12.96 10.12 62 220158 55751 110313328
Orthostatic hypotension 12.94 10.12 78 220142 66171 110302908
Chills 12.91 10.12 285 219935 190295 110178784
Device breakage 12.88 10.12 58 220162 13711 110355368
Myoglobinuria 12.87 10.12 14 220206 1214 110367865
Respiratory sinus arrhythmia magnitude 12.84 10.12 5 220215 68 110369011
Homeless 12.82 10.12 6 220214 131 110368948
Substance use 12.76 10.12 20 220200 2486 110366593
Metastases to central nervous system 12.74 10.12 16 220204 22801 110346278
Kidney transplant rejection 12.73 10.12 4 220216 11983 110357096
Abscess sterile 12.70 10.12 5 220215 70 110369009
Therapy partial responder 12.69 10.12 35 220185 37026 110332053
Gastric haemorrhage 12.68 10.12 8 220212 15907 110353172
Cachexia 12.68 10.12 5 220215 13000 110356079
Metabolic syndrome 12.65 10.12 23 220197 3224 110365855
Respiratory symptom 12.63 10.12 7 220213 14938 110354141
Essential tremor 12.62 10.12 17 220203 1841 110367238
Eosinophil count abnormal 12.60 10.12 13 220207 1061 110368018
Distractibility 12.60 10.12 12 220208 889 110368190
Dyspepsia 12.53 10.12 287 219933 190678 110178401
Pancreatic carcinoma 12.52 10.12 7 220213 14865 110354214
Stress cardiomyopathy 12.52 10.12 8 220212 15798 110353281
Squamous cell carcinoma 12.49 10.12 11 220209 18452 110350627
Persecutory delusion 12.48 10.12 34 220186 6257 110362822
Hepatitis cholestatic 12.46 10.12 10 220210 17556 110351523
Femur fracture 12.43 10.12 46 220174 44423 110324656
Hypotonic urinary bladder 12.39 10.12 5 220215 75 110369004
Self-injurious ideation 12.38 10.12 27 220193 4319 110364760
Cushingoid 12.27 10.12 4 220216 11708 110357371
Erythema induratum 12.27 10.12 7 220213 233 110368846
Pulmonary mass 12.21 10.12 36 220184 37265 110331814
Torsade de pointes 12.20 10.12 82 220138 22518 110346561
Ear infection 12.18 10.12 184 220036 62548 110306531
Visuospatial deficit 12.16 10.12 4 220216 32 110369047
Pneumonia bacterial 12.14 10.12 21 220199 26240 110342839
Dysmenorrhoea 12.12 10.12 24 220196 3586 110365493
Carbon monoxide poisoning 12.12 10.12 8 220212 347 110368732
Urinary incontinence 12.10 10.12 149 220071 48438 110320641
Urosepsis 12.04 10.12 27 220193 30648 110338431
Bone pain 12.04 10.12 78 220142 65055 110304024
Herpes zoster 12 10.12 148 220072 108231 110260848
Hyperthermia 11.98 10.12 78 220142 21194 110347885
Subacute cutaneous lupus erythematosus 11.98 10.12 29 220191 4965 110364114
Priapism 11.95 10.12 32 220188 5829 110363250
Bursitis 11.90 10.12 341 219879 129577 110239502
Discomfort 11.85 10.12 331 219889 214376 110154703
Right ventricular failure 11.77 10.12 21 220199 25933 110343146
Seizure like phenomena 11.76 10.12 19 220201 2422 110366657
Tension 11.67 10.12 29 220191 5049 110364030
Food craving 11.64 10.12 17 220203 1986 110367093
Medication error 11.62 10.12 144 220076 105222 110263857
Blood alkaline phosphatase increased 11.62 10.12 88 220132 70847 110298232
Cardiac tamponade 11.61 10.12 4 220216 11303 110357776
Polyarthritis 11.59 10.12 71 220149 18892 110350187
Left ventricular dysfunction 11.59 10.12 18 220202 23475 110345604
Haemorrhagic ovarian cyst 11.57 10.12 10 220210 653 110368426
Bankruptcy 11.55 10.12 4 220216 38 110369041
Osteoarthritis 11.55 10.12 276 219944 182347 110186732
Narcolepsy 11.51 10.12 15 220205 1573 110367506
Progressive multifocal leukoencephalopathy 11.49 10.12 20 220200 24936 110344143
Cutaneous lupus erythematosus 11.49 10.12 23 220197 3465 110365614
Ejaculation failure 11.47 10.12 8 220212 380 110368699
Chorea 11.46 10.12 22 220198 3213 110365866
Tic 11.46 10.12 23 220197 3470 110365609
Rhinorrhoea 11.44 10.12 140 220080 102526 110266553
Infection 11.41 10.12 597 219623 361603 110007476
Back injury 11.39 10.12 52 220168 47347 110321732
Blood pressure systolic abnormal 11.37 10.12 20 220200 24830 110344249
Acute hepatic failure 11.36 10.12 36 220184 36432 110332647
Myocarditis 11.36 10.12 27 220193 30028 110339051
Swollen tongue 11.31 10.12 72 220148 60290 110308789
Reactive psychosis 11.28 10.12 3 220217 10 110369069
Non-alcoholic steatohepatitis 11.28 10.12 19 220201 2508 110366571
Infusion site discomfort 11.27 10.12 16 220204 1821 110367258
Cerebral ischaemia 11.24 10.12 5 220215 12099 110356980
Transfusion 11.21 10.12 21 220199 25451 110343628
Mixed liver injury 11.20 10.12 5 220215 12074 110357005
Enteritis 11.15 10.12 13 220207 19143 110349936
Blood albumin decreased 11.14 10.12 24 220196 27628 110341451
Dry mouth 11.10 10.12 308 219912 199640 110169439
Gastritis erosive 11.08 10.12 5 220215 11995 110357084
Hepatocellular carcinoma 11.03 10.12 3 220217 9877 110359202
Immune effector cell-associated neurotoxicity syndrome 11.02 10.12 8 220212 14774 110354305
Sensory loss 11.01 10.12 16 220204 21441 110347638
Subarachnoid haemorrhage 10.98 10.12 27 220193 29675 110339404
Coma 10.97 10.12 310 219910 117559 110251520
Apnoea 10.97 10.12 55 220165 13584 110355495
Dysgraphia 10.95 10.12 27 220193 4678 110364401
Faeces discoloured 10.94 10.12 33 220187 33915 110335164
Therapy cessation 10.93 10.12 137 220083 44720 110324359
Bundle branch block right 10.92 10.12 51 220169 12240 110356839
Posture abnormal 10.90 10.12 26 220194 4412 110364667
Haemorrhagic stroke 10.89 10.12 7 220213 13782 110355297
Snoring 10.89 10.12 34 220186 6750 110362329
Blood testosterone decreased 10.88 10.12 20 220200 2828 110366251
Mouth ulceration 10.87 10.12 54 220166 48084 110320995
Pharyngeal exudate 10.86 10.12 3 220217 12 110369067
High density lipoprotein increased 10.85 10.12 14 220206 1455 110367624
Stoma site ulcer 10.83 10.12 7 220213 293 110368786
Purpura 10.82 10.12 20 220200 24368 110344711
Cystitis interstitial 10.81 10.12 14 220206 1460 110367619
Ideas of reference 10.79 10.12 6 220214 190 110368889
Adverse drug reaction 10.78 10.12 281 219939 105278 110263801
Product dose omission in error 10.78 10.12 82 220138 23430 110345649
Blood pressure diastolic abnormal 10.74 10.12 22 220198 25793 110343286
Oscillopsia 10.70 10.12 8 220212 424 110368655
Red blood cell count decreased 10.69 10.12 82 220138 65841 110303238
Pain in jaw 10.67 10.12 59 220161 51118 110317961
Meniscus removal 10.67 10.12 3 220217 13 110369066
Energy increased 10.66 10.12 23 220197 3651 110365428
Family stress 10.59 10.12 10 220210 733 110368346
Immune reconstitution inflammatory syndrome 10.58 10.12 10 220210 16216 110352863
Contraindicated product administered 10.58 10.12 600 219620 247667 110121412
Electric shock sensation 10.58 10.12 16 220204 1928 110367151
Factitious disorder 10.54 10.12 6 220214 199 110368880
Tooth fracture 10.52 10.12 53 220167 13114 110355965
Drug abuser 10.49 10.12 29 220191 5380 110363699
Neurodermatitis 10.46 10.12 20 220200 2912 110366167
Panic disorder 10.43 10.12 22 220198 3439 110365640
Pulmonary toxicity 10.38 10.12 12 220208 17734 110351345
Toxic optic neuropathy 10.35 10.12 13 220207 1315 110367764
Oesophageal candidiasis 10.35 10.12 5 220215 11529 110357550
Iron deficiency 10.27 10.12 13 220207 18463 110350616
Tri-iodothyronine free decreased 10.27 10.12 8 220212 451 110368628
Organising pneumonia 10.24 10.12 8 220212 14235 110354844
Bacterial sepsis 10.18 10.12 4 220216 10422 110358657
Constipation 10.17 10.12 836 219384 356950 110012129
Fear 10.14 10.12 80 220140 23113 110345966

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC A08AA62 ALIMENTARY TRACT AND METABOLISM
ANTIOBESITY PREPARATIONS, EXCL. DIET PRODUCTS
ANTIOBESITY PREPARATIONS, EXCL. DIET PRODUCTS
Centrally acting antiobesity products
ATC N06AX12 NERVOUS SYSTEM
PSYCHOANALEPTICS
ANTIDEPRESSANTS
Other antidepressants
ATC N06AX62 NERVOUS SYSTEM
PSYCHOANALEPTICS
ANTIDEPRESSANTS
Other antidepressants
FDA MoA N0000000102 Norepinephrine Uptake Inhibitors
FDA MoA N0000000114 Dopamine Uptake Inhibitors
FDA PE N0000009282 Increased Dopamine Activity
FDA PE N0000009456 Increased Norepinephrine Activity
CHEBI has role CHEBI:35469 antidepressant
CHEBI has role CHEBI:35474 anxiolytic drug
CHEBI has role CHEBI:35476 antipsychotic agent
CHEBI has role CHEBI:35526 hypoglycemic agent
CHEBI has role CHEBI:35610 antineoplastic agent
CHEBI has role CHEBI:35703 xenobiotic
CHEBI has role CHEBI:74518 anti-obesity agent
CHEBI has role CHEBI:75835 anti-anaemic agent
CHEBI has role CHEBI:78298 environmental contaminant
MeSH PA D000077444 Smoking Cessation Agents
MeSH PA D000928 Antidepressive Agents
MeSH PA D004791 Enzyme Inhibitors
MeSH PA D011619 Psychotropic Drugs
MeSH PA D014179 Neurotransmitter Uptake Inhibitors
MeSH PA D015259 Dopamine Agents
MeSH PA D018377 Neurotransmitter Agents
MeSH PA D018687 Antidepressive Agents, Second-Generation
MeSH PA D018765 Dopamine Uptake Inhibitors
MeSH PA D049990 Membrane Transport Modulators
MeSH PA D065607 Cytochrome P-450 Enzyme Inhibitors
MeSH PA D065690 Cytochrome P-450 CYP2D6 Inhibitors
FDA EPC N0000180855 Aminoketone

Related Drugs by ATC class:

A08AA Centrally acting antiobesity products 15 drugs
N06AX Other antidepressants 28 drugs

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

DiseaseRelationSNOMED_IDDOID
Depressive disorder indication 35489007
Nicotine dependence indication 56294008 DOID:0050742
Seasonal affective disorder indication 247803002
Major depressive disorder indication 370143000
Smoking cessation assistance indication 384742004
Obesity indication 414916001 DOID:9970
Bipolar affective disorder, current episode depression off-label use 191627008 DOID:3312
Attention deficit hyperactivity disorder off-label use 406506008
Suicidal thoughts contraindication 6471006
Alcoholism contraindication 7200002
Mood swings contraindication 18963009
Lowered convulsive threshold contraindication 19260006
Cirrhosis of liver contraindication 19943007 DOID:5082
Myocardial infarction contraindication 22298006 DOID:5844
Feeling agitated contraindication 24199005
Hypertensive disorder contraindication 38341003 DOID:10763
Anorexia nervosa contraindication 56882008 DOID:8689
Hepatic failure contraindication 59927004
Psychotic disorder contraindication 69322001
Opioid dependence contraindication 75544000 DOID:2559
Bulimia nervosa contraindication 78004001
Hostile behavior contraindication 79351003
Injury of head contraindication 82271004
Weight loss contraindication 89362005
Kidney disease contraindication 90708001 DOID:557
Secondary malignant neoplasm of cerebrum contraindication 94248000
Neoplasm of central nervous system contraindication 126951006 DOID:3620
Seizure disorder contraindication 128613002
Bipolar affective disorder, current episode manic contraindication 191618007
Disease of liver contraindication 235856003 DOID:409
Diabetic - poor control contraindication 268519009
Alcohol withdrawal-induced convulsion contraindication 308742005
Panic disorder contraindication 371631005 DOID:594
Sedative Drug Dependence contraindication
Seizure due to Abrupt Benzodiazepine Withdrawal contraindication
Stimulant Drug Dependence contraindication




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 7.87 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
174MG APLENZIN BAUSCH N022108 April 23, 2008 RX TABLET, EXTENDED RELEASE ORAL 7569610 June 27, 2026 TREATMENT OF MAJOR DEPRESSIVE DISORDER BY DOSING AT INTERVALS OF 24 HOURS
348MG APLENZIN BAUSCH N022108 April 23, 2008 RX TABLET, EXTENDED RELEASE ORAL 7569610 June 27, 2026 TREATMENT OF MAJOR DEPRESSIVE DISORDER BY DOSING AT INTERVALS OF 24 HOURS
522MG APLENZIN BAUSCH N022108 April 23, 2008 RX TABLET, EXTENDED RELEASE ORAL 7569610 June 27, 2026 TREATMENT OF MAJOR DEPRESSIVE DISORDER BY DOSING AT INTERVALS OF 24 HOURS
90MG;8MG CONTRAVE NALPROPION N200063 Sept. 10, 2014 RX TABLET, EXTENDED RELEASE ORAL 9107837 June 4, 2027 USE OF NALTREXONE AND BUPROPION IN EXTENDED-RELEASE FORM FOR CHRONIC WEIGHT MANAGEMENT FOR TREATING OVERWEIGHT OR OBESITY
90MG;8MG CONTRAVE NALPROPION N200063 Sept. 10, 2014 RX TABLET, EXTENDED RELEASE ORAL 10307376 Nov. 8, 2027 USE OF NALTREXONE AND BUPROPION BASED ON AN ESCALATING DOSE SCHEDULE
90MG;8MG CONTRAVE NALPROPION N200063 Sept. 10, 2014 RX TABLET, EXTENDED RELEASE ORAL 12048769 Nov. 8, 2027 USE OF NALTREXONE AND BUPROPION BASED ON AN ESCALATING DOSE SCHEDULE
90MG;8MG CONTRAVE NALPROPION N200063 Sept. 10, 2014 RX TABLET, EXTENDED RELEASE ORAL 8318788 Nov. 8, 2027 USE OF NALTREXONE AND BUPROPION IN A LAYERED FORMULATION FOR CHRONIC WEIGHT MANAGEMENT FOR AFFECTING WEIGHT LOSS
90MG;8MG CONTRAVE NALPROPION N200063 Sept. 10, 2014 RX TABLET, EXTENDED RELEASE ORAL 8722085 Nov. 8, 2027 USE OF NALTREXONE AND BUPROPION BASED ON AN ESCALATING DOSE SCHEDULE
90MG;8MG CONTRAVE NALPROPION N200063 Sept. 10, 2014 RX TABLET, EXTENDED RELEASE ORAL 9125868 Nov. 8, 2027 USE OF NALTREXONE AND BUPROPION BASED ON AN ESCALATING DOSE SCHEDULE
90MG;8MG CONTRAVE NALPROPION N200063 Sept. 10, 2014 RX TABLET, EXTENDED RELEASE ORAL 11324741 May 29, 2029 FOR CHRONIC WEIGHT MANAGEMENT FOR TREATING OVERWEIGHT OR OBESITY
90MG;8MG CONTRAVE NALPROPION N200063 Sept. 10, 2014 RX TABLET, EXTENDED RELEASE ORAL 8916195 Feb. 2, 2030 USE OF NALTREXONE AND BUPROPION IN EXTENDED-RELEASE FORM FOR CHRONIC WEIGHT MANAGEMENT FOR TREATING OVERWEIGHT OR OBESITY
90MG;8MG CONTRAVE NALPROPION N200063 Sept. 10, 2014 RX TABLET, EXTENDED RELEASE ORAL 11033543 Jan. 10, 2031 FOR CHRONIC WEIGHT MANAGEMENT FOR TREATING OVERWEIGHT OR OBESITY
90MG;8MG CONTRAVE NALPROPION N200063 Sept. 10, 2014 RX TABLET, EXTENDED RELEASE ORAL 9248123 Jan. 13, 2032 USE OF NALTREXONE AND BUPROPION FOR CHRONIC WEIGHT MANAGEMENT FOR TREATING OVERWEIGHT OR OBESITY IN PATIENTS WITH MAJOR DEPRESSIVE DISORDER
105MG;30MG AUVELITY AXSOME N215430 April 30, 2026 RX TABLET, EXTENDED RELEASE ORAL 8569328 July 18, 2032 THE TREATMENT OF AGITATION ASSOCIATED WITH DEMENTIA DUE TO ALZHEIMER’S DISEASE
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 8569328 July 18, 2032 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 8569328 July 18, 2032 THE TREATMENT OF AGITATION ASSOCIATED WITH DEMENTIA DUE TO ALZHEIMER’S DISEASE
90MG;8MG CONTRAVE NALPROPION N200063 Sept. 10, 2014 RX TABLET, EXTENDED RELEASE ORAL 10403170 June 5, 2033 FOR CHRONIC WEIGHT MANAGEMENT FOR TREATING OVERWEIGHT OR OBESITY
90MG;8MG CONTRAVE NALPROPION N200063 Sept. 10, 2014 RX TABLET, EXTENDED RELEASE ORAL 11139056 June 5, 2033 FOR CHRONIC WEIGHT MANAGEMENT FOR TREATING OVERWEIGHT OR OBESITY
90MG;8MG CONTRAVE NALPROPION N200063 Sept. 10, 2014 RX TABLET, EXTENDED RELEASE ORAL 9633575 June 25, 2033 FOR CHRONIC WEIGHT MANAGEMENT FOR TREATING OVERWEIGHT OR OBESITY
90MG;8MG CONTRAVE NALPROPION N200063 Sept. 10, 2014 RX TABLET, EXTENDED RELEASE ORAL 10231964 July 2, 2034 FOR CHRONIC WEIGHT MANAGEMENT FOR TREATING OVERWEIGHT OR OBESITY
90MG;8MG CONTRAVE NALPROPION N200063 Sept. 10, 2014 RX TABLET, EXTENDED RELEASE ORAL 10828294 July 2, 2034 FOR CHRONIC WEIGHT MANAGEMENT FOR TREATING OVERWEIGHT OR OBESITY
90MG;8MG CONTRAVE NALPROPION N200063 Sept. 10, 2014 RX TABLET, EXTENDED RELEASE ORAL 10835527 July 2, 2034 FOR CHRONIC WEIGHT MANAGEMENT FOR TREATING OVERWEIGHT OR OBESITY
90MG;8MG CONTRAVE NALPROPION N200063 Sept. 10, 2014 RX TABLET, EXTENDED RELEASE ORAL 11998542 July 2, 2034 FOR CHRONIC WEIGHT MANAGEMENT FOR TREATING OVERWEIGHT OR OBESITY
105MG;30MG AUVELITY AXSOME N215430 April 30, 2026 RX TABLET, EXTENDED RELEASE ORAL 10058518 Nov. 5, 2034 THE TREATMENT OF AGITATION ASSOCIATED WITH DEMENTIA DUE TO ALZHEIMER’S DISEASE BY REDUCING A TROUGH EFFECT OF DEXTROMETHORPHAN IN EXTENSIVE METABOLIZERS OF DEXTROMETHORPHAN
105MG;30MG AUVELITY AXSOME N215430 April 30, 2026 RX TABLET, EXTENDED RELEASE ORAL 10064857 Nov. 5, 2034 THE TREATMENT OF AGITATION ASSOCIATED WITH DEMENTIA DUE TO ALZHEIMER’S DISEASE BY INCREASING DEXTROMETHORPHAN PLASMA LEVELS IN EXTENSIVE METABOLIZERS OF DEXTROMETHORPHAN
105MG;30MG AUVELITY AXSOME N215430 April 30, 2026 RX TABLET, EXTENDED RELEASE ORAL 10080727 Nov. 5, 2034 THE TREATMENT OF AGITATION ASSOCIATED WITH DEMENTIA DUE TO ALZHEIMER’S DISEASE BY INCREASING THE METABOLIC LIFETIME OF DEXTROMETHORPHAN IN EXTENSIVE METABOLIZERS OF DEXTROMETHORPHAN
105MG;30MG AUVELITY AXSOME N215430 April 30, 2026 RX TABLET, EXTENDED RELEASE ORAL 10092560 Nov. 5, 2034 THE TREATMENT OF AGITATION ASSOCIATED WITH DEMENTIA DUE TO ALZHEIMER’S DISEASE BY INCREASING DEXTROMETHORPHAN PLASMA LEVELS IN EXTENSIVE METABOLIZERS OF DEXTROMETHORPHAN
105MG;30MG AUVELITY AXSOME N215430 April 30, 2026 RX TABLET, EXTENDED RELEASE ORAL 10092561 Nov. 5, 2034 THE TREATMENT OF AGITATION ASSOCIATED WITH DEMENTIA DUE TO ALZHEIMER’S DISEASE BY INCREASING DEXTROMETHORPHAN PLASMA LEVELS IN EXTENSIVE METABOLIZERS OF DEXTROMETHORPHAN
105MG;30MG AUVELITY AXSOME N215430 April 30, 2026 RX TABLET, EXTENDED RELEASE ORAL 10105361 Nov. 5, 2034 THE TREATMENT OF AGITATION ASSOCIATED WITH DEMENTIA DUE TO ALZHEIMER’S DISEASE BY REDUCING A TROUGH EFFECT OF DEXTROMETHORPHAN IN EXTENSIVE METABOLIZERS OF DEXTROMETHORPHAN
105MG;30MG AUVELITY AXSOME N215430 April 30, 2026 RX TABLET, EXTENDED RELEASE ORAL 10251879 Nov. 5, 2034 THE TREATMENT OF AGITATION ASSOCIATED WITH DEMENTIA DUE TO ALZHEIMER’S DISEASE BY INCREASING DEXTROMETHORPHAN PLASMA LEVELS IN EXTENSIVE METABOLIZERS OF DEXTROMETHORPHAN
105MG;30MG AUVELITY AXSOME N215430 April 30, 2026 RX TABLET, EXTENDED RELEASE ORAL 10463634 Nov. 5, 2034 THE TREATMENT OF AGITATION ASSOCIATED WITH DEMENTIA DUE TO ALZHEIMER’S DISEASE BY INCREASING DEXTROMETHORPHAN PLASMA LEVELS IN EXTENSIVE METABOLIZERS OF DEXTROMETHORPHAN
105MG;30MG AUVELITY AXSOME N215430 April 30, 2026 RX TABLET, EXTENDED RELEASE ORAL 10512643 Nov. 5, 2034 THE TREATMENT OF AGITATION ASSOCIATED WITH DEMENTIA DUE TO ALZHEIMER’S DISEASE BY INCREASING DEXTROMETHORPHAN PLASMA LEVELS IN EXTENSIVE METABOLIZERS OF DEXTROMETHORPHAN
105MG;30MG AUVELITY AXSOME N215430 April 30, 2026 RX TABLET, EXTENDED RELEASE ORAL 10780066 Nov. 5, 2034 THE TREATMENT OF AGITATION ASSOCIATED WITH DEMENTIA DUE TO ALZHEIMER’S DISEASE BY INCREASING DEXTROMETHORPHAN PLASMA LEVELS IN EXTENSIVE METABOLIZERS OF DEXTROMETHORPHAN
105MG;30MG AUVELITY AXSOME N215430 April 30, 2026 RX TABLET, EXTENDED RELEASE ORAL 10881624 Nov. 5, 2034 THE TREATMENT OF AGITATION ASSOCIATED WITH DEMENTIA DUE TO ALZHEIMER’S DISEASE BY INCREASING DEXTROMETHORPHAN PLASMA LEVELS IN EXTENSIVE METABOLIZERS OF DEXTROMETHORPHAN
105MG;30MG AUVELITY AXSOME N215430 April 30, 2026 RX TABLET, EXTENDED RELEASE ORAL 11007189 Nov. 5, 2034 THE TREATMENT OF AGITATION ASSOCIATED WITH DEMENTIA DUE TO ALZHEIMER’S DISEASE
105MG;30MG AUVELITY AXSOME N215430 April 30, 2026 RX TABLET, EXTENDED RELEASE ORAL 11207281 Nov. 5, 2034 THE TREATMENT OF AGITATION ASSOCIATED WITH DEMENTIA DUE TO ALZHEIMER’S DISEASE BY REDUCING PLASMA LEVELS OF DEXTRORPHAN O-GLUCOURONIDE IN NON-POOR METABOLIZERS OF DEXTROMETHORPHAN
105MG;30MG AUVELITY AXSOME N215430 April 30, 2026 RX TABLET, EXTENDED RELEASE ORAL 11234946 Nov. 5, 2034 THE TREATMENT OF AGITATION ASSOCIATED WITH DEMENTIA DUE TO ALZHEIMER’S DISEASE BY INCREASING DEXTROMETHORPHAN PLASMA LEVELS IN NON-POOR METABOLIZERS OF DEXTROMETHORPHAN
105MG;30MG AUVELITY AXSOME N215430 April 30, 2026 RX TABLET, EXTENDED RELEASE ORAL 11253492 Nov. 5, 2034 THE TREATMENT OF AGITATION ASSOCIATED WITH DEMENTIA DUE TO ALZHEIMER’S DISEASE BY INCREASING DEXTROMETHORPHAN PLASMA LEVELS IN NON-POOR METABOLIZERS OF DEXTROMETHORPHAN
105MG;30MG AUVELITY AXSOME N215430 April 30, 2026 RX TABLET, EXTENDED RELEASE ORAL 11273133 Nov. 5, 2034 THE TREATMENT OF AGITATION ASSOCIATED WITH DEMENTIA DUE TO ALZHEIMER’S DISEASE BY INCREASING DEXTROMETHORPHAN PLASMA LEVELS IN NON-POOR METABOLIZERS OF DEXTROMETHORPHAN
105MG;30MG AUVELITY AXSOME N215430 April 30, 2026 RX TABLET, EXTENDED RELEASE ORAL 11273134 Nov. 5, 2034 THE TREATMENT OF AGITATION ASSOCIATED WITH DEMENTIA DUE TO ALZHEIMER’S DISEASE BY INCREASING DEXTROMETHORPHAN PLASMA LEVELS IN EXTENSIVE METABOLIZERS OF DEXTROMETHORPHAN
105MG;30MG AUVELITY AXSOME N215430 April 30, 2026 RX TABLET, EXTENDED RELEASE ORAL 11285118 Nov. 5, 2034 THE TREATMENT OF AGITATION ASSOCIATED WITH DEMENTIA DUE TO ALZHEIMER’S DISEASE BY INCREASING DEXTROMETHORPHAN PLASMA LEVELS IN NON-POOR METABOLIZERS OF DEXTROMETHORPHAN
105MG;30MG AUVELITY AXSOME N215430 April 30, 2026 RX TABLET, EXTENDED RELEASE ORAL 11285146 Nov. 5, 2034 THE TREATMENT OF AGITATION ASSOCIATED WITH DEMENTIA DUE TO ALZHEIMER’S DISEASE BY INCREASING DEXTROMETHORPHAN PLASMA LEVELS IN EXTENSIVE METABOLIZERS OF DEXTROMETHORPHAN
105MG;30MG AUVELITY AXSOME N215430 April 30, 2026 RX TABLET, EXTENDED RELEASE ORAL 11291638 Nov. 5, 2034 THE TREATMENT OF AGITATION ASSOCIATED WITH DEMENTIA DUE TO ALZHEIMER’S DISEASE BY INCREASING DEXTROMETHORPHAN PLASMA LEVELS IN EXTENSIVE METABOLIZERS OF DEXTROMETHORPHAN
105MG;30MG AUVELITY AXSOME N215430 April 30, 2026 RX TABLET, EXTENDED RELEASE ORAL 11291665 Nov. 5, 2034 THE TREATMENT OF AGITATION ASSOCIATED WITH DEMENTIA DUE TO ALZHEIMER’S DISEASE BY INCREASING DEXTROMETHORPHAN PLASMA LEVELS IN EXTENSIVE METABOLIZERS OF DEXTROMETHORPHAN
105MG;30MG AUVELITY AXSOME N215430 April 30, 2026 RX TABLET, EXTENDED RELEASE ORAL 11298352 Nov. 5, 2034 THE TREATMENT OF AGITATION ASSOCIATED WITH DEMENTIA DUE TO ALZHEIMER’S DISEASE BY INCREASING DEXTROMETHORPHAN PLASMA LEVELS IN EXTENSIVE METABOLIZERS OF DEXTROMETHORPHAN
105MG;30MG AUVELITY AXSOME N215430 April 30, 2026 RX TABLET, EXTENDED RELEASE ORAL 11344544 Nov. 5, 2034 THE TREATMENT OF AGITATION ASSOCIATED WITH DEMENTIA DUE TO ALZHEIMER’S DISEASE BY INCREASING DEXTROMETHORPHAN PLASMA LEVELS IN EXTENSIVE METABOLIZERS OF DEXTROMETHORPHAN
105MG;30MG AUVELITY AXSOME N215430 April 30, 2026 RX TABLET, EXTENDED RELEASE ORAL 11382874 Nov. 5, 2034 THE TREATMENT OF AGITATION ASSOCIATED WITH DEMENTIA DUE TO ALZHEIMER’S DISEASE BY INCREASING DEXTROMETHORPHAN PLASMA LEVELS IN EXTENSIVE METABOLIZERS OF DEXTROMETHORPHAN
105MG;30MG AUVELITY AXSOME N215430 April 30, 2026 RX TABLET, EXTENDED RELEASE ORAL 11419867 Nov. 5, 2034 THE TREATMENT OF AGITATION ASSOCIATED WITH DEMENTIA DUE TO ALZHEIMER’S DISEASE BY INCREASING DEXTROMETHORPHAN PLASMA LEVELS IN EXTENSIVE METABOLIZERS OF DEXTROMETHORPHAN
105MG;30MG AUVELITY AXSOME N215430 April 30, 2026 RX TABLET, EXTENDED RELEASE ORAL 11426370 Nov. 5, 2034 THE TREATMENT OF AGITATION ASSOCIATED WITH DEMENTIA DUE TO ALZHEIMER’S DISEASE BY INCREASING DEXTROMETHORPHAN PLASMA LEVELS IN NON-POOR METABOLIZERS OF DEXTROMETHORPHAN
105MG;30MG AUVELITY AXSOME N215430 April 30, 2026 RX TABLET, EXTENDED RELEASE ORAL 11571417 Nov. 5, 2034 THE TREATMENT OF AGITATION ASSOCIATED WITH DEMENTIA DUE TO ALZHEIMER’S DISEASE BY INCREASING DEXTROMETHORPHAN PLASMA LEVELS IN NON-POOR METABOLIZERS OF DEXTROMETHORPHAN
105MG;30MG AUVELITY AXSOME N215430 April 30, 2026 RX TABLET, EXTENDED RELEASE ORAL 11590124 Nov. 5, 2034 THE TREATMENT OF AGITATION ASSOCIATED WITH DEMENTIA DUE TO ALZHEIMER’S DISEASE BY INCREASING DEXTROMETHORPHAN PLASMA LEVELS IN NON-POOR METABOLIZERS OF DEXTROMETHORPHAN
105MG;30MG AUVELITY AXSOME N215430 April 30, 2026 RX TABLET, EXTENDED RELEASE ORAL 11617747 Nov. 5, 2034 THE TREATMENT OF AGITATION ASSOCIATED WITH DEMENTIA DUE TO ALZHEIMER’S DISEASE BY INCREASING DEXTROMETHORPHAN PLASMA LEVELS IN NON-POOR METABOLIZERS OF DEXTROMETHORPHAN
105MG;30MG AUVELITY AXSOME N215430 April 30, 2026 RX TABLET, EXTENDED RELEASE ORAL 9168234 Nov. 5, 2034 THE TREATMENT OF AGITATION ASSOCIATED WITH DEMENTIA DUE TO ALZHEIMER’S DISEASE BY INCREASING DEXTROMETHORPHAN PLASMA LEVELS IN EXTENSIVE METABOLIZERS OF DEXTROMETHORPHAN
105MG;30MG AUVELITY AXSOME N215430 April 30, 2026 RX TABLET, EXTENDED RELEASE ORAL 9198905 Nov. 5, 2034 THE TREATMENT OF AGITATION ASSOCIATED WITH DEMENTIA DUE TO ALZHEIMER’S DISEASE BY INCREASING THE METABOLIC LIFETIME OF DEXTROMETHORPHAN IN EXTENSIVE METABOLIZERS OF DEXTROMETHORPHAN
105MG;30MG AUVELITY AXSOME N215430 April 30, 2026 RX TABLET, EXTENDED RELEASE ORAL 9205083 Nov. 5, 2034 THE TREATMENT OF AGITATION ASSOCIATED WITH DEMENTIA DUE TO ALZHEIMER’S DISEASE BY INCREASING THE METABOLIC LIFETIME OF DEXTROMETHORPHAN IN EXTENSIVE METABOLIZERS OF DEXTROMETHORPHAN
105MG;30MG AUVELITY AXSOME N215430 April 30, 2026 RX TABLET, EXTENDED RELEASE ORAL 9238032 Nov. 5, 2034 THE TREATMENT OF AGITATION ASSOCIATED WITH DEMENTIA DUE TO ALZHEIMER’S DISEASE BY INCREASING THE METABOLIC LIFETIME OF DEXTROMETHORPHAN IN EXTENSIVE METABOLIZERS OF DEXTROMETHORPHAN
105MG;30MG AUVELITY AXSOME N215430 April 30, 2026 RX TABLET, EXTENDED RELEASE ORAL 9278095 Nov. 5, 2034 THE TREATMENT OF AGITATION ASSOCIATED WITH DEMENTIA DUE TO ALZHEIMER’S DISEASE BY INCREASING DEXTROMETHORPHAN PLASMA LEVELS IN EXTENSIVE METABOLIZERS OF DEXTROMETHORPHAN
105MG;30MG AUVELITY AXSOME N215430 April 30, 2026 RX TABLET, EXTENDED RELEASE ORAL 9314462 Nov. 5, 2034 THE TREATMENT OF AGITATION ASSOCIATED WITH DEMENTIA DUE TO ALZHEIMER’S DISEASE BY INCREASING DEXTROMETHORPHAN PLASMA LEVELS IN EXTENSIVE METABOLIZERS OF DEXTROMETHORPHAN
105MG;30MG AUVELITY AXSOME N215430 April 30, 2026 RX TABLET, EXTENDED RELEASE ORAL 9370513 Nov. 5, 2034 THE TREATMENT OF AGITATION ASSOCIATED WITH DEMENTIA DUE TO ALZHEIMER’S DISEASE BY INCREASING THE METABOLIC LIFETIME OF DEXTROMETHORPHAN IN EXTENSIVE METABOLIZERS OF DEXTROMETHORPHAN
105MG;30MG AUVELITY AXSOME N215430 April 30, 2026 RX TABLET, EXTENDED RELEASE ORAL 9375429 Nov. 5, 2034 THE TREATMENT OF AGITATION ASSOCIATED WITH DEMENTIA DUE TO ALZHEIMER’S DISEASE BY INCREASING DEXTROMETHORPHAN PLASMA LEVELS IN EXTENSIVE METABOLIZERS OF DEXTROMETHORPHAN
105MG;30MG AUVELITY AXSOME N215430 April 30, 2026 RX TABLET, EXTENDED RELEASE ORAL 9408815 Nov. 5, 2034 THE TREATMENT OF AGITATION ASSOCIATED WITH DEMENTIA DUE TO ALZHEIMER’S DISEASE BY INCREASING DEXTROMETHORPHAN PLASMA LEVELS IN EXTENSIVE METABOLIZERS OF DEXTROMETHORPHAN
105MG;30MG AUVELITY AXSOME N215430 April 30, 2026 RX TABLET, EXTENDED RELEASE ORAL 9421176 Nov. 5, 2034 THE TREATMENT OF AGITATION ASSOCIATED WITH DEMENTIA DUE TO ALZHEIMER’S DISEASE BY INCREASING DEXTROMETHORPHAN PLASMA LEVELS IN EXTENSIVE METABOLIZERS OF DEXTROMETHORPHAN
105MG;30MG AUVELITY AXSOME N215430 April 30, 2026 RX TABLET, EXTENDED RELEASE ORAL 9457023 Nov. 5, 2034 THE TREATMENT OF AGITATION ASSOCIATED WITH DEMENTIA DUE TO ALZHEIMER’S DISEASE BY INCREASING DEXTROMETHORPHAN PLASMA LEVELS IN EXTENSIVE METABOLIZERS OF DEXTROMETHORPHAN
105MG;30MG AUVELITY AXSOME N215430 April 30, 2026 RX TABLET, EXTENDED RELEASE ORAL 9457025 Nov. 5, 2034 THE TREATMENT OF AGITATION ASSOCIATED WITH DEMENTIA DUE TO ALZHEIMER’S DISEASE BY INCREASING DEXTROMETHORPHAN PLASMA LEVELS IN EXTENSIVE METABOLIZERS OF DEXTROMETHORPHAN
105MG;30MG AUVELITY AXSOME N215430 April 30, 2026 RX TABLET, EXTENDED RELEASE ORAL 9474731 Nov. 5, 2034 THE TREATMENT OF AGITATION ASSOCIATED WITH DEMENTIA DUE TO ALZHEIMER’S DISEASE BY INCREASING THE METABOLIC LIFETIME OF DEXTROMETHORPHAN IN EXTENSIVE METABOLIZERS OF DEXTROMETHORPHAN
105MG;30MG AUVELITY AXSOME N215430 April 30, 2026 RX TABLET, EXTENDED RELEASE ORAL 9486450 Nov. 5, 2034 THE TREATMENT OF AGITATION ASSOCIATED WITH DEMENTIA DUE TO ALZHEIMER’S DISEASE BY INCREASING DEXTROMETHORPHAN PLASMA LEVELS IN EXTENSIVE METABOLIZERS OF DEXTROMETHORPHAN
105MG;30MG AUVELITY AXSOME N215430 April 30, 2026 RX TABLET, EXTENDED RELEASE ORAL 9700528 Nov. 5, 2034 THE TREATMENT OF AGITATION ASSOCIATED WITH DEMENTIA DUE TO ALZHEIMER’S DISEASE BY INCREASING DEXTROMETHORPHAN PLASMA LEVELS IN EXTENSIVE METABOLIZERS OF DEXTROMETHORPHAN
105MG;30MG AUVELITY AXSOME N215430 April 30, 2026 RX TABLET, EXTENDED RELEASE ORAL 9700553 Nov. 5, 2034 THE TREATMENT OF AGITATION ASSOCIATED WITH DEMENTIA DUE TO ALZHEIMER’S DISEASE BY INCREASING DEXTROMETHORPHAN PLASMA LEVELS IN EXTENSIVE METABOLIZERS OF DEXTROMETHORPHAN
105MG;30MG AUVELITY AXSOME N215430 April 30, 2026 RX TABLET, EXTENDED RELEASE ORAL 9707191 Nov. 5, 2034 THE TREATMENT OF AGITATION ASSOCIATED WITH DEMENTIA DUE TO ALZHEIMER’S DISEASE BY REDUCING A TROUGH EFFECT OF DEXTROMETHORPHAN IN EXTENSIVE METABOLIZERS OF DEXTROMETHORPHAN
105MG;30MG AUVELITY AXSOME N215430 April 30, 2026 RX TABLET, EXTENDED RELEASE ORAL 9763932 Nov. 5, 2034 THE TREATMENT OF AGITATION ASSOCIATED WITH DEMENTIA DUE TO ALZHEIMER’S DISEASE BY INCREASING DEXTROMETHORPHAN PLASMA LEVELS IN EXTENSIVE METABOLIZERS OF DEXTROMETHORPHAN
105MG;30MG AUVELITY AXSOME N215430 April 30, 2026 RX TABLET, EXTENDED RELEASE ORAL 9861595 Nov. 5, 2034 THE TREATMENT OF AGITATION ASSOCIATED WITH DEMENTIA DUE TO ALZHEIMER’S DISEASE BY INCREASING DEXTROMETHORPHAN PLASMA LEVELS IN EXTENSIVE METABOLIZERS OF DEXTROMETHORPHAN
105MG;30MG AUVELITY AXSOME N215430 April 30, 2026 RX TABLET, EXTENDED RELEASE ORAL 9867819 Nov. 5, 2034 THE TREATMENT OF AGITATION ASSOCIATED WITH DEMENTIA DUE TO ALZHEIMER’S DISEASE BY INCREASING DEXTROMETHORPHAN PLASMA LEVELS IN EXTENSIVE METABOLIZERS OF DEXTROMETHORPHAN
105MG;30MG AUVELITY AXSOME N215430 April 30, 2026 RX TABLET, EXTENDED RELEASE ORAL 9968568 Nov. 5, 2034 THE TREATMENT OF AGITATION ASSOCIATED WITH DEMENTIA DUE TO ALZHEIMER’S DISEASE BY INCREASING DEXTROMETHORPHAN PLASMA LEVELS IN EXTENSIVE METABOLIZERS OF DEXTROMETHORPHAN
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 10058518 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 10058518 Nov. 5, 2034 THE TREATMENT OF AGITATION ASSOCIATED WITH DEMENTIA DUE TO ALZHEIMER’S DISEASE BY REDUCING A TROUGH EFFECT OF DEXTROMETHORPHAN IN EXTENSIVE METABOLIZERS OF DEXTROMETHORPHAN
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 10064857 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 10064857 Nov. 5, 2034 THE TREATMENT OF AGITATION ASSOCIATED WITH DEMENTIA DUE TO ALZHEIMER’S DISEASE BY INCREASING DEXTROMETHORPHAN PLASMA LEVELS IN EXTENSIVE METABOLIZERS OF DEXTROMETHORPHAN
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 10080727 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 10080727 Nov. 5, 2034 THE TREATMENT OF AGITATION ASSOCIATED WITH DEMENTIA DUE TO ALZHEIMER’S DISEASE BY INCREASING THE METABOLIC LIFETIME OF DEXTROMETHORPHAN IN EXTENSIVE METABOLIZERS OF DEXTROMETHORPHAN
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 10092560 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 10092560 Nov. 5, 2034 THE TREATMENT OF AGITATION ASSOCIATED WITH DEMENTIA DUE TO ALZHEIMER’S DISEASE BY INCREASING DEXTROMETHORPHAN PLASMA LEVELS IN EXTENSIVE METABOLIZERS OF DEXTROMETHORPHAN
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 10092561 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 10092561 Nov. 5, 2034 THE TREATMENT OF AGITATION ASSOCIATED WITH DEMENTIA DUE TO ALZHEIMER’S DISEASE BY INCREASING DEXTROMETHORPHAN PLASMA LEVELS IN EXTENSIVE METABOLIZERS OF DEXTROMETHORPHAN
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 10105327 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 10105361 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 10105361 Nov. 5, 2034 THE TREATMENT OF AGITATION ASSOCIATED WITH DEMENTIA DUE TO ALZHEIMER’S DISEASE BY REDUCING A TROUGH EFFECT OF DEXTROMETHORPHAN IN EXTENSIVE METABOLIZERS OF DEXTROMETHORPHAN
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 10251879 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 10251879 Nov. 5, 2034 THE TREATMENT OF AGITATION ASSOCIATED WITH DEMENTIA DUE TO ALZHEIMER’S DISEASE BY INCREASING DEXTROMETHORPHAN PLASMA LEVELS IN EXTENSIVE METABOLIZERS OF DEXTROMETHORPHAN
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 10463634 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 10463634 Nov. 5, 2034 THE TREATMENT OF AGITATION ASSOCIATED WITH DEMENTIA DUE TO ALZHEIMER’S DISEASE BY INCREASING DEXTROMETHORPHAN PLASMA LEVELS IN EXTENSIVE METABOLIZERS OF DEXTROMETHORPHAN
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 10512643 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 10512643 Nov. 5, 2034 THE TREATMENT OF AGITATION ASSOCIATED WITH DEMENTIA DUE TO ALZHEIMER’S DISEASE BY INCREASING DEXTROMETHORPHAN PLASMA LEVELS IN EXTENSIVE METABOLIZERS OF DEXTROMETHORPHAN
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 10548857 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 10596167 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 10596167 Nov. 5, 2034 THE TREATMENT OF AGITATION ASSOCIATED WITH DEMENTIA DUE TO ALZHEIMER’S DISEASE BY INCREASING DEXTROMETHORPHAN PLASMA LEVELS IN EXTENSIVE METABOLIZERS OF DEXTROMETHORPHAN
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 10772850 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 10780066 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 10780066 Nov. 5, 2034 THE TREATMENT OF AGITATION ASSOCIATED WITH DEMENTIA DUE TO ALZHEIMER’S DISEASE BY INCREASING DEXTROMETHORPHAN PLASMA LEVELS IN EXTENSIVE METABOLIZERS OF DEXTROMETHORPHAN
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 10786469 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 10786496 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 10786496 Nov. 5, 2034 THE TREATMENT OF AGITATION ASSOCIATED WITH DEMENTIA DUE TO ALZHEIMER’S DISEASE BY INCREASING DEXTROMETHORPHAN PLASMA LEVELS IN EXTENSIVE METABOLIZERS OF DEXTROMETHORPHAN
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 10799497 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 10806710 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 10806710 Nov. 5, 2034 THE TREATMENT OF AGITATION ASSOCIATED WITH DEMENTIA DUE TO ALZHEIMER’S DISEASE BY INCREASING DEXTROMETHORPHAN PLASMA LEVELS IN EXTENSIVE METABOLIZERS OF DEXTROMETHORPHAN
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 10864209 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 10874663 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 10874664 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 10874665 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 10881624 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 10881624 Nov. 5, 2034 THE TREATMENT OF AGITATION ASSOCIATED WITH DEMENTIA DUE TO ALZHEIMER’S DISEASE BY INCREASING DEXTROMETHORPHAN PLASMA LEVELS IN EXTENSIVE METABOLIZERS OF DEXTROMETHORPHAN
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 10881657 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 10894046 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 10894047 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 10898453 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 10933034 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 10945973 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 10966941 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 10966941 Nov. 5, 2034 THE TREATMENT OF AGITATION ASSOCIATED WITH DEMENTIA DUE TO ALZHEIMER’S DISEASE BY INCREASING DEXTROMETHORPHAN PLASMA LEVELS IN EXTENSIVE METABOLIZERS OF DEXTROMETHORPHAN
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 10966974 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 11007189 Nov. 5, 2034 THE TREATMENT OF AGITATION ASSOCIATED WITH DEMENTIA DUE TO ALZHEIMER’S DISEASE
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 11020389 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 11058648 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 11065248 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 11065248 Nov. 5, 2034 THE TREATMENT OF AGITATION ASSOCIATED WITH DEMENTIA DUE TO ALZHEIMER’S DISEASE BY INCREASING DEXTROMETHORPHAN PLASMA LEVELS IN EXTENSIVE METABOLIZERS OF DEXTROMETHORPHAN
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 11090300 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 11096937 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 11123343 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 11123344 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 11123344 Nov. 5, 2034 THE TREATMENT OF AGITATION ASSOCIATED WITH DEMENTIA DUE TO ALZHEIMER’S DISEASE BY INCREASING DEXTROMETHORPHAN PLASMA LEVELS IN EXTENSIVE METABOLIZERS OF DEXTROMETHORPHAN
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 11129826 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 11141388 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 11141416 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 11147808 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 11185515 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 11191739 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 11191739 Nov. 5, 2034 THE TREATMENT OF AGITATION ASSOCIATED WITH DEMENTIA DUE TO ALZHEIMER’S DISEASE
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 11197839 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 11197839 Nov. 5, 2034 THE TREATMENT OF AGITATION ASSOCIATED WITH DEMENTIA DUE TO ALZHEIMER’S DISEASE
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 11207281 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 11207281 Nov. 5, 2034 THE TREATMENT OF AGITATION ASSOCIATED WITH DEMENTIA DUE TO ALZHEIMER’S DISEASE BY REDUCING PLASMA LEVELS OF DEXTRORPHAN O-GLUCOURONIDE IN NON-POOR METABOLIZERS OF DEXTROMETHORPHAN
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 11213521 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 11229640 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 11234946 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 11234946 Nov. 5, 2034 THE TREATMENT OF AGITATION ASSOCIATED WITH DEMENTIA DUE TO ALZHEIMER’S DISEASE BY INCREASING DEXTROMETHORPHAN PLASMA LEVELS IN NON-POOR METABOLIZERS OF DEXTROMETHORPHAN
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 11253491 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 11253492 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 11253492 Nov. 5, 2034 THE TREATMENT OF AGITATION ASSOCIATED WITH DEMENTIA DUE TO ALZHEIMER’S DISEASE BY INCREASING DEXTROMETHORPHAN PLASMA LEVELS IN NON-POOR METABOLIZERS OF DEXTROMETHORPHAN
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 11273133 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 11273133 Nov. 5, 2034 THE TREATMENT OF AGITATION ASSOCIATED WITH DEMENTIA DUE TO ALZHEIMER’S DISEASE BY INCREASING DEXTROMETHORPHAN PLASMA LEVELS IN NON-POOR METABOLIZERS OF DEXTROMETHORPHAN
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 11273134 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 11273134 Nov. 5, 2034 THE TREATMENT OF AGITATION ASSOCIATED WITH DEMENTIA DUE TO ALZHEIMER’S DISEASE BY INCREASING DEXTROMETHORPHAN PLASMA LEVELS IN EXTENSIVE METABOLIZERS OF DEXTROMETHORPHAN
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 11285118 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 11285118 Nov. 5, 2034 THE TREATMENT OF AGITATION ASSOCIATED WITH DEMENTIA DUE TO ALZHEIMER’S DISEASE BY INCREASING DEXTROMETHORPHAN PLASMA LEVELS IN NON-POOR METABOLIZERS OF DEXTROMETHORPHAN
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 11285146 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 11285146 Nov. 5, 2034 THE TREATMENT OF AGITATION ASSOCIATED WITH DEMENTIA DUE TO ALZHEIMER’S DISEASE BY INCREASING DEXTROMETHORPHAN PLASMA LEVELS IN EXTENSIVE METABOLIZERS OF DEXTROMETHORPHAN
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 11291638 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 11291638 Nov. 5, 2034 THE TREATMENT OF AGITATION ASSOCIATED WITH DEMENTIA DUE TO ALZHEIMER’S DISEASE BY INCREASING DEXTROMETHORPHAN PLASMA LEVELS IN EXTENSIVE METABOLIZERS OF DEXTROMETHORPHAN
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 11291665 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 11291665 Nov. 5, 2034 THE TREATMENT OF AGITATION ASSOCIATED WITH DEMENTIA DUE TO ALZHEIMER’S DISEASE BY INCREASING DEXTROMETHORPHAN PLASMA LEVELS IN EXTENSIVE METABOLIZERS OF DEXTROMETHORPHAN
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 11298351 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 11298352 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 11298352 Nov. 5, 2034 THE TREATMENT OF AGITATION ASSOCIATED WITH DEMENTIA DUE TO ALZHEIMER’S DISEASE BY INCREASING DEXTROMETHORPHAN PLASMA LEVELS IN EXTENSIVE METABOLIZERS OF DEXTROMETHORPHAN
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 11311534 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 11344544 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 11344544 Nov. 5, 2034 THE TREATMENT OF AGITATION ASSOCIATED WITH DEMENTIA DUE TO ALZHEIMER’S DISEASE BY INCREASING DEXTROMETHORPHAN PLASMA LEVELS IN EXTENSIVE METABOLIZERS OF DEXTROMETHORPHAN
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 11357744 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 11357744 Nov. 5, 2034 THE TREATMENT OF AGITATION ASSOCIATED WITH DEMENTIA DUE TO ALZHEIMER’S DISEASE BY INCREASING DEXTROMETHORPHAN PLASMA LEVELS IN EXTENSIVE METABOLIZERS OF DEXTROMETHORPHAN
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 11364233 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 11382874 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 11382874 Nov. 5, 2034 THE TREATMENT OF AGITATION ASSOCIATED WITH DEMENTIA DUE TO ALZHEIMER’S DISEASE BY INCREASING DEXTROMETHORPHAN PLASMA LEVELS IN EXTENSIVE METABOLIZERS OF DEXTROMETHORPHAN
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 11419867 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 11419867 Nov. 5, 2034 THE TREATMENT OF AGITATION ASSOCIATED WITH DEMENTIA DUE TO ALZHEIMER’S DISEASE BY INCREASING DEXTROMETHORPHAN PLASMA LEVELS IN EXTENSIVE METABOLIZERS OF DEXTROMETHORPHAN
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 11426370 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 11426370 Nov. 5, 2034 THE TREATMENT OF AGITATION ASSOCIATED WITH DEMENTIA DUE TO ALZHEIMER’S DISEASE BY INCREASING DEXTROMETHORPHAN PLASMA LEVELS IN NON-POOR METABOLIZERS OF DEXTROMETHORPHAN
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 11426401 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 11426401 Nov. 5, 2034 THE TREATMENT OF AGITATION ASSOCIATED WITH DEMENTIA DUE TO ALZHEIMER’S DISEASE BY INCREASING DEXTROMETHORPHAN PLASMA LEVELS IN EXTENSIVE METABOLIZERS OF DEXTROMETHORPHAN
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 11433067 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 11433067 Nov. 5, 2034 THE TREATMENT OF AGITATION ASSOCIATED WITH DEMENTIA DUE TO ALZHEIMER’S DISEASE
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 11439636 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 11439636 Nov. 5, 2034 THE TREATMENT OF AGITATION ASSOCIATED WITH DEMENTIA DUE TO ALZHEIMER’S DISEASE BY INCREASING DEXTROMETHORPHAN PLASMA LEVELS IN EXTENSIVE METABOLIZERS OF DEXTROMETHORPHAN
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 11478468 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 11497721 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 11510918 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 11517542 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 11517543 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 11524007 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 11524008 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 11534414 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 11534414 Nov. 5, 2034 THE TREATMENT OF AGITATION ASSOCIATED WITH DEMENTIA DUE TO ALZHEIMER’S DISEASE
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 11541021 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 11541048 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 11571417 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 11571417 Nov. 5, 2034 THE TREATMENT OF AGITATION ASSOCIATED WITH DEMENTIA DUE TO ALZHEIMER’S DISEASE BY INCREASING DEXTROMETHORPHAN PLASMA LEVELS IN NON-POOR METABOLIZERS OF DEXTROMETHORPHAN
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 11576909 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 11576909 Nov. 5, 2034 THE TREATMENT OF AGITATION ASSOCIATED WITH DEMENTIA DUE TO ALZHEIMER’S DISEASE BY INCREASING DEXTROMETHORPHAN PLASMA LEVELS IN NON-POOR METABOLIZERS OF DEXTROMETHORPHAN
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 11590124 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 11590124 Nov. 5, 2034 THE TREATMENT OF AGITATION ASSOCIATED WITH DEMENTIA DUE TO ALZHEIMER’S DISEASE BY INCREASING DEXTROMETHORPHAN PLASMA LEVELS IN NON-POOR METABOLIZERS OF DEXTROMETHORPHAN
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 11596627 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 11617728 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 11617747 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO INCREASE DEXTROMETHORPHAN PLASMA LEVELS
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 11617747 Nov. 5, 2034 THE TREATMENT OF AGITATION ASSOCIATED WITH DEMENTIA DUE TO ALZHEIMER’S DISEASE BY INCREASING DEXTROMETHORPHAN PLASMA LEVELS IN NON-POOR METABOLIZERS OF DEXTROMETHORPHAN
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 11779579 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 11969421 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 12109178 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 9168234 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 9168234 Nov. 5, 2034 THE TREATMENT OF AGITATION ASSOCIATED WITH DEMENTIA DUE TO ALZHEIMER’S DISEASE BY INCREASING DEXTROMETHORPHAN PLASMA LEVELS IN EXTENSIVE METABOLIZERS OF DEXTROMETHORPHAN
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 9198905 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 9198905 Nov. 5, 2034 THE TREATMENT OF AGITATION ASSOCIATED WITH DEMENTIA DUE TO ALZHEIMER’S DISEASE BY INCREASING THE METABOLIC LIFETIME OF DEXTROMETHORPHAN IN EXTENSIVE METABOLIZERS OF DEXTROMETHORPHAN
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 9205083 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 9205083 Nov. 5, 2034 THE TREATMENT OF AGITATION ASSOCIATED WITH DEMENTIA DUE TO ALZHEIMER’S DISEASE BY INCREASING THE METABOLIC LIFETIME OF DEXTROMETHORPHAN IN EXTENSIVE METABOLIZERS OF DEXTROMETHORPHAN
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 9238032 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 9238032 Nov. 5, 2034 THE TREATMENT OF AGITATION ASSOCIATED WITH DEMENTIA DUE TO ALZHEIMER’S DISEASE BY INCREASING THE METABOLIC LIFETIME OF DEXTROMETHORPHAN IN EXTENSIVE METABOLIZERS OF DEXTROMETHORPHAN
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 9278095 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 9278095 Nov. 5, 2034 THE TREATMENT OF AGITATION ASSOCIATED WITH DEMENTIA DUE TO ALZHEIMER’S DISEASE BY INCREASING DEXTROMETHORPHAN PLASMA LEVELS IN EXTENSIVE METABOLIZERS OF DEXTROMETHORPHAN
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 9314462 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 9314462 Nov. 5, 2034 THE TREATMENT OF AGITATION ASSOCIATED WITH DEMENTIA DUE TO ALZHEIMER’S DISEASE BY INCREASING DEXTROMETHORPHAN PLASMA LEVELS IN EXTENSIVE METABOLIZERS OF DEXTROMETHORPHAN
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 9370513 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 9370513 Nov. 5, 2034 THE TREATMENT OF AGITATION ASSOCIATED WITH DEMENTIA DUE TO ALZHEIMER’S DISEASE BY INCREASING THE METABOLIC LIFETIME OF DEXTROMETHORPHAN IN EXTENSIVE METABOLIZERS OF DEXTROMETHORPHAN
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 9375429 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 9375429 Nov. 5, 2034 THE TREATMENT OF AGITATION ASSOCIATED WITH DEMENTIA DUE TO ALZHEIMER’S DISEASE BY INCREASING DEXTROMETHORPHAN PLASMA LEVELS IN EXTENSIVE METABOLIZERS OF DEXTROMETHORPHAN
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 9408815 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 9408815 Nov. 5, 2034 THE TREATMENT OF AGITATION ASSOCIATED WITH DEMENTIA DUE TO ALZHEIMER’S DISEASE BY INCREASING DEXTROMETHORPHAN PLASMA LEVELS IN EXTENSIVE METABOLIZERS OF DEXTROMETHORPHAN
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 9421176 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 9421176 Nov. 5, 2034 THE TREATMENT OF AGITATION ASSOCIATED WITH DEMENTIA DUE TO ALZHEIMER’S DISEASE BY INCREASING DEXTROMETHORPHAN PLASMA LEVELS IN EXTENSIVE METABOLIZERS OF DEXTROMETHORPHAN
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 9457023 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 9457023 Nov. 5, 2034 THE TREATMENT OF AGITATION ASSOCIATED WITH DEMENTIA DUE TO ALZHEIMER’S DISEASE BY INCREASING DEXTROMETHORPHAN PLASMA LEVELS IN EXTENSIVE METABOLIZERS OF DEXTROMETHORPHAN
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 9457025 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 9457025 Nov. 5, 2034 THE TREATMENT OF AGITATION ASSOCIATED WITH DEMENTIA DUE TO ALZHEIMER’S DISEASE BY INCREASING DEXTROMETHORPHAN PLASMA LEVELS IN EXTENSIVE METABOLIZERS OF DEXTROMETHORPHAN
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 9474731 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 9474731 Nov. 5, 2034 THE TREATMENT OF AGITATION ASSOCIATED WITH DEMENTIA DUE TO ALZHEIMER’S DISEASE BY INCREASING THE METABOLIC LIFETIME OF DEXTROMETHORPHAN IN EXTENSIVE METABOLIZERS OF DEXTROMETHORPHAN
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 9486450 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 9486450 Nov. 5, 2034 THE TREATMENT OF AGITATION ASSOCIATED WITH DEMENTIA DUE TO ALZHEIMER’S DISEASE BY INCREASING DEXTROMETHORPHAN PLASMA LEVELS IN EXTENSIVE METABOLIZERS OF DEXTROMETHORPHAN
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 9700528 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 9700528 Nov. 5, 2034 THE TREATMENT OF AGITATION ASSOCIATED WITH DEMENTIA DUE TO ALZHEIMER’S DISEASE BY INCREASING DEXTROMETHORPHAN PLASMA LEVELS IN EXTENSIVE METABOLIZERS OF DEXTROMETHORPHAN
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 9700553 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 9700553 Nov. 5, 2034 THE TREATMENT OF AGITATION ASSOCIATED WITH DEMENTIA DUE TO ALZHEIMER’S DISEASE BY INCREASING DEXTROMETHORPHAN PLASMA LEVELS IN EXTENSIVE METABOLIZERS OF DEXTROMETHORPHAN
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 9707191 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 9707191 Nov. 5, 2034 THE TREATMENT OF AGITATION ASSOCIATED WITH DEMENTIA DUE TO ALZHEIMER’S DISEASE BY REDUCING A TROUGH EFFECT OF DEXTROMETHORPHAN IN EXTENSIVE METABOLIZERS OF DEXTROMETHORPHAN
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 9763932 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 9763932 Nov. 5, 2034 THE TREATMENT OF AGITATION ASSOCIATED WITH DEMENTIA DUE TO ALZHEIMER’S DISEASE BY INCREASING DEXTROMETHORPHAN PLASMA LEVELS IN EXTENSIVE METABOLIZERS OF DEXTROMETHORPHAN
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 9861595 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 9861595 Nov. 5, 2034 THE TREATMENT OF AGITATION ASSOCIATED WITH DEMENTIA DUE TO ALZHEIMER’S DISEASE BY INCREASING DEXTROMETHORPHAN PLASMA LEVELS IN EXTENSIVE METABOLIZERS OF DEXTROMETHORPHAN
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 9867819 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 9867819 Nov. 5, 2034 THE TREATMENT OF AGITATION ASSOCIATED WITH DEMENTIA DUE TO ALZHEIMER’S DISEASE BY INCREASING DEXTROMETHORPHAN PLASMA LEVELS IN EXTENSIVE METABOLIZERS OF DEXTROMETHORPHAN
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 9968568 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 9968568 Nov. 5, 2034 THE TREATMENT OF AGITATION ASSOCIATED WITH DEMENTIA DUE TO ALZHEIMER’S DISEASE BY INCREASING DEXTROMETHORPHAN PLASMA LEVELS IN EXTENSIVE METABOLIZERS OF DEXTROMETHORPHAN
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 10780064 Jan. 7, 2040 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 10925842 Jan. 7, 2040 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 10940124 Jan. 7, 2040 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 10966942 Jan. 7, 2040 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;30MG AUVELITY AXSOME N215430 April 30, 2026 RX TABLET, EXTENDED RELEASE ORAL 12433884 June 5, 2040 THE TREATMENT OF AGITATION ASSOCIATED WITH DEMENTIA DUE TO ALZHEIMER’S DISEASE IN A PATIENT WHO IS AN EXTENSIVE METABOLIZER OF DEXTROMETHORPHAN
105MG;30MG AUVELITY AXSOME N215430 April 30, 2026 RX TABLET, EXTENDED RELEASE ORAL 12472156 June 5, 2040 THE TREATMENT OF AGITATION ASSOCIATED WITH DEMENTIA DUE TO ALZHEIMER’S DISEASE
105MG;30MG AUVELITY AXSOME N215430 April 30, 2026 RX TABLET, EXTENDED RELEASE ORAL 12576078 June 5, 2040 THE TREATMENT OF AGITATION ASSOCIATED WITH DEMENTIA DUE TO ALZHEIMER’S DISEASE
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 12433884 June 5, 2040 THE TREATMENT OF AGITATION ASSOCIATED WITH DEMENTIA DUE TO ALZHEIMER’S DISEASE IN A PATIENT WHO IS AN EXTENSIVE METABOLIZER OF DEXTROMETHORPHAN
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 12472156 June 5, 2040 THE TREATMENT OF AGITATION ASSOCIATED WITH DEMENTIA DUE TO ALZHEIMER’S DISEASE
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 12576078 June 5, 2040 THE TREATMENT OF AGITATION ASSOCIATED WITH DEMENTIA DUE TO ALZHEIMER’S DISEASE
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 11896563 Dec. 1, 2041 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 12390428 Dec. 1, 2041 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;30MG AUVELITY AXSOME N215430 April 30, 2026 RX TABLET, EXTENDED RELEASE ORAL 12472174 Jan. 20, 2043 THE TREATMENT OF AGITATION ASSOCIATED WITH DEMENTIA DUE TO ALZHEIMER’S DISEASE IN A PATIENT WHO CONSUMES ALCOHOL, AND WHO REDUCES, BUT DOES NOT DISCONTINUE, CONSUMPTION OF ALCOHOL
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 11717518 Jan. 20, 2043 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 11925636 Jan. 20, 2043 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 12239642 Jan. 20, 2043 THE TREATMENT OF AGITATION ASSOCIATED WITH DEMENTIA DUE TO ALZHEIMER’S DISEASE IN A PATIENT WHO CONSUMES ALCOHOL, AND WHO REDUCES, BUT DOES NOT DISCONTINUE, CONSUMPTION OF ALCOHOL
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 12263161 Jan. 20, 2043 THE TREATMENT OF AGITATION ASSOCIATED WITH DEMENTIA DUE TO ALZHEIMER’S DISEASE IN A PATIENT WHO CONSUMES ALCOHOL, AND WHO REDUCES, BUT DOES NOT DISCONTINUE, CONSUMPTION OF ALCOHOL
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 12310961 Jan. 20, 2043 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 12357697 Jan. 20, 2043 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 12472174 Jan. 20, 2043 THE TREATMENT OF AGITATION ASSOCIATED WITH DEMENTIA DUE TO ALZHEIMER’S DISEASE IN A PATIENT WHO CONSUMES ALCOHOL, AND WHO REDUCES, BUT DOES NOT DISCONTINUE, CONSUMPTION OF ALCOHOL
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 12478622 Jan. 20, 2043 THE TREATMENT OF AGITATION ASSOCIATED WITH DEMENTIA DUE TO ALZHEIMER’S DISEASE IN A PATIENT WHO CONSUMES ALCOHOL, AND WHO REDUCES, BUT DOES NOT DISCONTINUE, CONSUMPTION OF ALCOHOL
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 12564587 Jan. 20, 2043 THE TREATMENT OF AGITATION ASSOCIATED WITH DEMENTIA DUE TO ALZHEIMER’S DISEASE IN A PATIENT WHO CONSUMES ALCOHOL, AND WHO REDUCES, BUT DOES NOT DISCONTINUE, CONSUMPTION OF ALCOHOL
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 11730706 Jan. 23, 2043 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 11883373 Jan. 23, 2043 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 12194005 Jan. 23, 2043 THE TREATMENT OF AGITATION ASSOCIATED WITH DEMENTIA DUE TO ALZHEIMER’S DISEASE IN A PATIENT WHO HAS MODERATE RENAL IMPAIRMENT
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 12364674 Jan. 23, 2043 THE TREATMENT OF AGITATION ASSOCIATED WITH DEMENTIA DUE TO ALZHEIMER’S DISEASE
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 11986444 Feb. 15, 2043 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 12036191 Feb. 15, 2043 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 12370154 Feb. 15, 2043 THE TREATMENT OF AGITATION ASSOCIATED WITH DEMENTIA DUE TO ALZHEIMER’S DISEASE IN A PATIENT WHO IS A POOR METABOLIZER OF CYP2D6
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 12599576 Feb. 15, 2043 THE TREATMENT OF AGITATION ASSOCIATED WITH DEMENTIA DUE TO ALZHEIMER’S DISEASE IN A PATIENT WHO IS A POOR METABOLIZER OF CYP2D6
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 11752144 Feb. 23, 2043 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 12042473 Feb. 23, 2043 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 12146889 Feb. 23, 2043 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 12472155 Feb. 23, 2043 THE TREATMENT OF AGITATION ASSOCIATED WITH DEMENTIA DUE TO ALZHEIMER’S DISEASE IN A PATIENT WITH A HISTORY OF DRUG ABUSE
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 11839612 March 2, 2043 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 11844797 April 20, 2043 TREATMENT OF MAJOR DEPRESSIVE DISORDER BY ADMINISTERING DEXTROMETHORPHAN AND BUPROPION TO A SUBJECT HAVING MODERATE HEPATIC IMPAIRMENT
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 12194036 April 20, 2043 THE TREATMENT OF AGITATION ASSOCIATED WITH DEMENTIA DUE TO ALZHEIMER’S DISEASE IN A PATIENT WHO HAS MODERATE HEPATIC IMPAIRMENT

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
105MG;30MG AUVELITY AXSOME N215430 April 30, 2026 RX TABLET, EXTENDED RELEASE ORAL April 30, 2029 TREATMENT OF AGITATION ASSOCIATED WITH DEMENTIA DUE TO ALZHEIMER’S DISEASE
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL April 30, 2029 TREATMENT OF AGITATION ASSOCIATED WITH DEMENTIA DUE TO ALZHEIMER’S DISEASE

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Sodium-dependent dopamine transporter Transporter INHIBITOR Kd 6.28 WOMBAT-PK CHEMBL
Sodium-dependent noradrenaline transporter Transporter INHIBITOR Ki 5.16 CHEMBL CHEMBL
Alpha-1A adrenergic receptor GPCR Ki 4.80 PDSP
Cytochrome P450 2D6 Enzyme WOMBAT-PK
Neuronal acetylcholine receptor subunit alpha-7 Ion channel IC50 4.30 CHEMBL
Cytochrome P450 2C19 Enzyme IC50 5.70 DRUG MATRIX
Neuronal acetylcholine receptor; alpha3/beta4 Ion channel IC50 5.74 CHEMBL
Potassium voltage-gated channel subfamily H member 2 Ion channel IC50 4.16 CHEMBL
Neuronal acetylcholine receptor; alpha3/beta2 Ion channel IC50 6 CHEMBL
Sodium-dependent serotonin transporter Transporter Kd 5.04 WOMBAT-PK
Membrane-associated progesterone receptor component 1 Membrane receptor Ki 5.85 DRUG MATRIX
Sodium-dependent dopamine transporter Transporter IC50 5.91 CHEMBL

External reference:

IDSource
4019645 VUID
N0000147738 NUI
D00817 KEGG_DRUG
31677-93-7 SECONDARY_CAS_RN
905818-69-1 SECONDARY_CAS_RN
203204 RXNORM
C0085208 UMLSCUI
CHEBI:3219 CHEBI
1XR PDB_CHEM_ID
CHEMBL894 ChEMBL_ID
DB01156 DRUGBANK_ID
CHEMBL1201735 ChEMBL_ID
CHEMBL1698 ChEMBL_ID
D016642 MESH_DESCRIPTOR_UI
444 PUBCHEM_CID
7135 IUPHAR_LIGAND_ID
3562 INN_ID
01ZG3TPX31 UNII
162122 MMSL
26259 MMSL
31548 MMSL
4307 MMSL
4319 MMSL
d00181 MMSL
387564004 SNOMEDCT_US
395733003 SNOMEDCT_US
431408005 SNOMEDCT_US
96199001 SNOMEDCT_US
4019483 VANDF
4019645 VANDF
4029878 VANDF
001512 NDDF
004611 NDDF
012996 NDDF
01ZG3TPX31 INXIGHT DRUGS

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Bupropion Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0115-5445 TABLET, FILM COATED, EXTENDED RELEASE 200 mg ORAL ANDA 30 sections
Bupropion Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0115-6811 TABLET, FILM COATED, EXTENDED RELEASE 150 mg ORAL ANDA 30 sections
WELLBUTRINSR HUMAN PRESCRIPTION DRUG LABEL 1 0173-0135 TABLET, FILM COATED 150 mg ORAL NDA 29 sections
WELLBUTRINSR HUMAN PRESCRIPTION DRUG LABEL 1 0173-0722 TABLET, FILM COATED 200 mg ORAL NDA 29 sections
WELLBUTRINSR HUMAN PRESCRIPTION DRUG LABEL 1 0173-0947 TABLET, FILM COATED 100 mg ORAL NDA 29 sections
WELLBUTRINXL HUMAN PRESCRIPTION DRUG LABEL 1 0187-0730 TABLET, EXTENDED RELEASE 150 mg ORAL NDA 28 sections
WELLBUTRINXL HUMAN PRESCRIPTION DRUG LABEL 1 0187-0731 TABLET, EXTENDED RELEASE 300 mg ORAL NDA 28 sections
Aplenzin HUMAN PRESCRIPTION DRUG LABEL 1 0187-5810 TABLET, EXTENDED RELEASE 174 mg ORAL NDA 29 sections
Aplenzin HUMAN PRESCRIPTION DRUG LABEL 1 0187-5811 TABLET, EXTENDED RELEASE 348 mg ORAL NDA 29 sections
Aplenzin HUMAN PRESCRIPTION DRUG LABEL 1 0187-5812 TABLET, EXTENDED RELEASE 522 mg ORAL NDA 29 sections
Bupropion Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0440-7200 TABLET, FILM COATED, EXTENDED RELEASE 150 mg ORAL ANDA 28 sections
Bupropion hydrochloride (XL) HUMAN PRESCRIPTION DRUG LABEL 1 0527-2415 TABLET, EXTENDED RELEASE 150 mg ORAL ANDA 21 sections
Bupropion hydrochloride (XL) HUMAN PRESCRIPTION DRUG LABEL 1 0527-2430 TABLET, EXTENDED RELEASE 300 mg ORAL ANDA 21 sections
Bupropion HydrochlorideXL HUMAN PRESCRIPTION DRUG LABEL 1 0591-3331 TABLET, FILM COATED, EXTENDED RELEASE 150 mg ORAL ANDA 29 sections
Bupropion HydrochlorideSR HUMAN PRESCRIPTION DRUG LABEL 1 0591-3540 TABLET, FILM COATED, EXTENDED RELEASE 100 mg ORAL ANDA 29 sections
Bupropion HydrochlorideSR HUMAN PRESCRIPTION DRUG LABEL 1 0591-3541 TABLET, FILM COATED, EXTENDED RELEASE 150 mg ORAL ANDA 29 sections
Bupropion HydrochlorideSR HUMAN PRESCRIPTION DRUG LABEL 1 0591-3542 TABLET, FILM COATED, EXTENDED RELEASE 200 mg ORAL ANDA 29 sections
Bupropion HydrochlorideSR HUMAN PRESCRIPTION DRUG LABEL 1 0591-3543 TABLET, FILM COATED, EXTENDED RELEASE 150 mg ORAL ANDA 29 sections
Bupropion HydrochlorideSR HUMAN PRESCRIPTION DRUG LABEL 1 0591-3543 TABLET, FILM COATED, EXTENDED RELEASE 150 mg ORAL ANDA 29 sections
bupropion Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0615-8261 TABLET 75 mg ORAL ANDA 29 sections
bupropion Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0615-8296 TABLET 100 mg ORAL ANDA 29 sections
Bupropion Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0615-8504 TABLET, EXTENDED RELEASE 150 mg ORAL ANDA 21 sections
Bupropion Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0615-8505 TABLET, EXTENDED RELEASE 300 mg ORAL ANDA 21 sections
BUPROPION HYDROCHLORIDE HUMAN PRESCRIPTION DRUG LABEL 1 0615-8581 TABLET, FILM COATED 75 mg ORAL ANDA 29 sections
BUPROPION HYDROCHLORIDE HUMAN PRESCRIPTION DRUG LABEL 1 0615-8582 TABLET, FILM COATED 100 mg ORAL ANDA 29 sections
Bupropion hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0615-8601 TABLET, EXTENDED RELEASE 100 mg ORAL ANDA 28 sections
Bupropion hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0615-8602 TABLET, EXTENDED RELEASE 150 mg ORAL ANDA 28 sections
Bupropion Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0904-6635 TABLET, FILM COATED 75 mg ORAL ANDA 21 sections
Bupropion Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0904-6636 TABLET, FILM COATED 100 mg ORAL ANDA 21 sections
bupropion hydrochlorideSR HUMAN PRESCRIPTION DRUG LABEL 1 0904-7099 TABLET, FILM COATED, EXTENDED RELEASE 100 mg ORAL ANDA 29 sections