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

Stem definitionDrug idCAS RN
2029 76-42-6

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • oxycontin
  • oxycodone
  • dihydro-14-hydroxycodeinone
  • dihydrohydroxycodeinone
  • dihydrone
  • oxicon
  • oxycodeinone
  • oxymorphone 3-methyl ether
  • oxynorm
  • oxycodone hydrochloride
  • oxycodone terephthalate
  • oxycodone hydrochloride hydrate
  • oxycodone HCl
A semisynthetic derivative of CODEINE.
  • Molecular weight: 315.37
  • Formula: C18H21NO4
  • CLOGP: -0.04
  • LIPINSKI: 0
  • HAC: 5
  • HDO: 1
  • TPSA: 59
  • ALOGS: -1.75
  • ROTB: 1

  • Status: OFP

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

Drug dosage:

DoseUnitRoute
75 mg O
30 mg P
75 mg O

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 1 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 100 mg/mL Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 19 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 1.06 ยตM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 42 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution) 2.50 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 6.10 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.55 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 5.50 hours Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
April 12, 1950 FDA ENDO PHARMS
Oct. 29, 2020 PMDA SHIONOGI PHARMA CO., LTD

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
Drug abuse 1597.19 9.92 1767 264943 58079 50280335
Drug abuser 1264.79 9.92 498 266212 2330 50336084
Completed suicide 1255.92 9.92 2385 264325 129504 50208910
Drug dependence 1075.68 9.92 867 265843 18892 50319522
Muscle injury 791.21 9.92 977 265733 36134 50302280
Folliculitis 782.67 9.92 999 265711 38226 50300188
Respiratory arrest 763.84 9.92 865 265845 29144 50309270
Irritable bowel syndrome 701.78 9.92 1092 265618 50349 50288065
Toxicity to various agents 692.79 9.92 2575 264135 209924 50128490
Lower respiratory tract infection 582.65 9.92 1441 265269 93760 50244654
Overdose 558.85 9.92 1460 265250 98267 50240147
Impaired healing 540.24 9.92 1159 265551 68627 50269787
Sleep disorder due to general medical condition, insomnia type 526.10 9.92 735 265975 30712 50307702
Inadequate analgesia 520.07 9.92 259 266451 2299 50336115
Drug withdrawal syndrome 452.39 9.92 608 266102 24473 50313941
Blister 434.64 9.92 1207 265503 84211 50254203
Stomatitis 429.72 9.92 1342 265368 100002 50238412
Ill-defined disorder 420.96 9.92 906 265804 53748 50284666
Cardio-respiratory arrest 420.41 9.92 898 265812 52994 50285420
Off label use 390.23 9.92 1245 265465 473181 49865233
Confusional state 386.75 9.92 1969 264741 183959 50154455
Gastrointestinal disorder 366.09 9.92 1213 265497 93243 50245171
Accidental overdose 297.94 9.92 437 266273 19096 50319318
Cardiac arrest 285.54 9.92 1030 265680 82621 50255793
Death 277.63 9.92 2775 263935 322604 50015810
Substance abuse 267.89 9.92 201 266509 3923 50334491
Peripheral swelling 249.37 9.92 1898 264812 204038 50134376
Sinusitis 208.07 9.92 1575 265135 168983 50169431
Muscle spasticity 199.13 9.92 339 266371 16845 50321569
Therapeutic product effect decreased 196.57 9.92 1309 265401 134741 50203673
Respiratory depression 190.87 9.92 274 266436 11736 50326678
Exposure during pregnancy 179.73 9.92 224 266486 120791 50217623
Infection 174.11 9.92 1529 265181 171425 50166989
Drug ineffective 162.19 9.92 3198 263512 816135 49522279
Weight increased 152.96 9.92 1682 265028 200209 50138205
Body temperature increased 151.53 9.92 435 266275 30906 50307508
Night sweats 148.99 9.92 452 266258 33122 50305292
Intentional product misuse 148.10 9.92 562 266148 46172 50292242
Cough 147.83 9.92 711 265999 240553 50097861
Condition aggravated 146.30 9.92 941 265769 296117 50042297
Ear pain 146 9.92 402 266308 27881 50310533
Pruritus 142.99 9.92 2192 264518 281376 50057038
Treatment failure 141.38 9.92 323 266387 137314 50201100
Poisoning 141.12 9.92 243 266467 12186 50326228
Product use issue 136.24 9.92 373 266337 149102 50189312
Maternal exposure during pregnancy 135.92 9.92 412 266298 159366 50179048
Drug screen positive 135.68 9.92 125 266585 3277 50335137
Duodenal ulcer perforation 135.16 9.92 537 266173 45074 50293340
Injection site pain 132.37 9.92 239 266471 110785 50227629
Helicobacter infection 126.84 9.92 559 266151 49143 50289271
Device expulsion 123.40 9.92 7 266703 28815 50309599
Delirium 119.95 9.92 458 266252 37734 50300680
Plasma cell myeloma 119.20 9.92 400 266310 30922 50307492
Product use in unapproved indication 117.95 9.92 273 266437 115546 50222868
Accidental death 117.75 9.92 87 266623 1657 50336757
Injection site erythema 114.08 9.92 136 266574 74800 50263614
Abortion spontaneous 113.72 9.92 39 266671 41733 50296681
Respiratory disorder 102.92 9.92 380 266330 30807 50307607
Constipation 102.66 9.92 1459 265251 184249 50154165
Nasopharyngitis 102.41 9.92 1505 265205 191422 50146992
Hyperaesthesia 102.40 9.92 167 266543 8006 50330408
Medication error 98.20 9.92 414 266296 35690 50302724
Injection site swelling 94.63 9.92 51 266659 41722 50296692
Injection site reaction 94.46 9.92 75 266635 49957 50288457
Joint swelling 91.07 9.92 1806 264904 243480 50094934
Product complaint 88.11 9.92 190 266520 11276 50327138
Mental status changes 87.31 9.92 401 266309 35871 50302543
Miosis 84.63 9.92 133 266577 6177 50332237
Contusion 83.16 9.92 931 265779 111252 50227162
Rheumatoid factor positive 80.78 9.92 86 266624 49773 50288641
Malaise 79.09 9.92 1268 265442 334264 50004150
Drug tolerance 75.39 9.92 111 266599 4865 50333549
Respiratory rate decreased 74.66 9.92 87 266623 3021 50335393
Red blood cell sedimentation rate abnormal 73.08 9.92 3 266707 16340 50322074
Product dose omission issue 71.89 9.92 621 266089 183217 50155197
Therapeutic product effect incomplete 71.48 9.92 245 266465 91270 50247144
Unresponsive to stimuli 71.17 9.92 335 266375 30274 50308140
Hypertension 70.04 9.92 743 265967 210460 50127954
Insomnia 68.39 9.92 1298 265412 173567 50164847
Dizziness 65.87 9.92 1359 265351 345010 49993404
Cardiac failure 64.65 9.92 196 266514 75844 50262570
Somnolence 64.62 9.92 1162 265548 153823 50184591
Headache 62.66 9.92 2115 264595 504420 49833994
Sopor 62.61 9.92 14 266696 19865 50318549
Exposure via ingestion 61.63 9.92 75 266635 2728 50335686
Back pain 61.12 9.92 1555 265155 218475 50119939
Pleural fibrosis 60.94 9.92 82 266628 3302 50335112
Drug resistance 60.56 9.92 13 266697 18976 50319438
Malignant neoplasm progression 59.72 9.92 585 266125 67539 50270875
Psoriasis 59.27 9.92 177 266533 68823 50269591
Presbyacusis 58.97 9.92 73 266637 2703 50335711
Alopecia 58.36 9.92 924 265786 244123 50094291
Soft tissue disorder 56.76 9.92 89 266621 4125 50334289
Drug interaction 55.48 9.92 730 265980 198891 50139523
Asthma 55.35 9.92 262 266448 89075 50249339
Drug reaction with eosinophilia and systemic symptoms 54.42 9.92 42 266668 28382 50310032
Blood magnesium increased 53.72 9.92 71 266639 2809 50335605
Injection site pruritus 53.71 9.92 81 266629 40330 50298084
Cholecystitis chronic 53.47 9.92 141 266569 9528 50328886
Delusional disorder, unspecified type 53.13 9.92 30 266680 351 50338063
Pleural thickening 53.06 9.92 67 266643 2532 50335882
Foetal exposure during pregnancy 52.92 9.92 40 266670 27319 50311095
Withdrawal syndrome 52.01 9.92 207 266503 17383 50321031
Acute lung injury 51.36 9.92 49 266661 1344 50337070
Nasal congestion 50.81 9.92 122 266588 50998 50287416
COVID-19 50.76 9.92 106 266604 46556 50291858
Cytomegalovirus infection 50.23 9.92 16 266694 17946 50320468
Palpitations 49.70 9.92 293 266417 94213 50244201
No adverse event 47.90 9.92 64 266646 33514 50304900
Swelling 47.36 9.92 1390 265320 199482 50138932
Atrial fibrillation 45.62 9.92 331 266379 101414 50237000
Musculoskeletal stiffness 45.43 9.92 445 266265 128036 50210378
Syncope 45.27 9.92 337 266373 102665 50235749
Live birth 45.21 9.92 15 266695 16393 50322021
Influenza 44.78 9.92 282 266428 89256 50249158
Anaphylactic reaction 44.76 9.92 141 266569 53914 50284500
Cataract 43.82 9.92 117 266593 47183 50291231
Vertigo 43.77 9.92 134 266576 51698 50286716
Nasal necrosis 43.60 9.92 17 266693 77 50338337
Mobility decreased 43.57 9.92 245 266465 79703 50258711
Premature delivery 42.77 9.92 37 266673 23626 50314788
Dependence 42.58 9.92 51 266659 1824 50336590
Pyrexia 41.98 9.92 2426 264284 377777 49960637
Vomiting 41.38 9.92 2888 263822 457870 49880544
Toxic leukoencephalopathy 41.01 9.92 31 266679 612 50337802
Injection site bruising 40.43 9.92 83 266627 36685 50301729
Osteosclerosis 39.64 9.92 68 266642 3399 50335015
Bone erosion 39.38 9.92 7 266703 11680 50326734
Accidental exposure to product by child 39.14 9.92 37 266673 1003 50337411
Product formulation issue 38.63 9.92 28 266682 517 50337897
Deafness neurosensory 38.57 9.92 78 266632 4423 50333991
Myalgia 38.52 9.92 444 266266 123875 50214539
Oropharyngeal pain 38.41 9.92 246 266464 77555 50260859
Depressed level of consciousness 38.39 9.92 431 266279 51522 50286892
Blood pressure increased 38.38 9.92 483 266227 132649 50205765
Hypersensitivity 38.18 9.92 1440 265270 213721 50124693
Productive cough 37.87 9.92 146 266564 52548 50285866
Erythema 37.58 9.92 544 266166 145870 50192544
Bone cyst 36.38 9.92 49 266661 1975 50336439
Drug detoxification 35.84 9.92 17 266693 134 50338280
Type 2 diabetes mellitus 35.80 9.92 80 266630 34295 50304119
Spinal cord ischaemia 35.47 9.92 11 266699 20 50338394
Narcotic bowel syndrome 35.10 9.92 16 266694 114 50338300
Pericarditis 34.55 9.92 595 266115 78094 50260320
Salpingo-oophorectomy unilateral 34.32 9.92 26 266684 515 50337899
Drug screen negative 34.28 9.92 20 266690 250 50338164
Epilepsy 34.04 9.92 38 266672 21529 50316885
Premature baby 33.97 9.92 28 266682 18309 50320105
Injury 33.96 9.92 401 266309 48524 50289890
Stress 33.75 9.92 157 266553 53636 50284778
Ear infection 33.60 9.92 53 266657 25917 50312497
Deep vein thrombosis 33.54 9.92 558 266152 72746 50265668
Pulmonary embolism 33.45 9.92 736 265974 100968 50237446
Tooth loss 33.13 9.92 89 266621 6081 50332333
Oesophageal motility disorder 33.11 9.92 21 266689 308 50338106
Compartment syndrome 32.64 9.92 46 266664 1936 50336478
Chest discomfort 32.41 9.92 322 266388 92400 50246014
Pain in extremity 32.07 9.92 1146 265564 271719 50066695
Lethargy 32.07 9.92 400 266310 49032 50289382
Angioedema 31.38 9.92 98 266612 37578 50300836
Lactic acidosis 31.28 9.92 82 266628 33273 50305141
Red blood cell sedimentation rate 30.56 9.92 62 266648 3524 50334890
Enthesopathy 30.19 9.92 95 266615 7098 50331316
Serotonin syndrome 29.93 9.92 228 266482 24485 50313929
Myelosuppression 29.89 9.92 17 266693 13500 50324914
Foetal megacystis 29.84 9.92 10 266700 26 50338388
Rhinorrhoea 29.80 9.92 155 266555 51428 50286986
Foetal death 29.61 9.92 4 266706 8176 50330238
Hypoglycaemia 29.30 9.92 164 266546 53417 50284997
Macular degeneration 29.18 9.92 20 266690 14368 50324046
Toxicologic test abnormal 29.03 9.92 25 266685 598 50337816
Epigastric discomfort 28.87 9.92 82 266628 5788 50332626
Rheumatic fever 28.56 9.92 28 266682 16839 50321575
Sphincter of Oddi dysfunction 28.51 9.92 20 266690 350 50338064
Sleep disorder 28.43 9.92 442 266268 56841 50281573
Immunodeficiency 28.27 9.92 22 266688 14806 50323608
Road traffic accident 28.01 9.92 222 266488 24130 50314284
Coma 27.89 9.92 438 266272 56441 50281973
Abdominal pain upper 27.71 9.92 1064 265646 158245 50180169
Bronchitis 27.42 9.92 385 266325 103774 50234640
Device difficult to use 27.30 9.92 9 266701 9877 50328537
Swollen joint count increased 27.19 9.92 23 266687 14850 50323564
Hypoxia 27.13 9.92 399 266311 50724 50287690
Feeling hot 26.66 9.92 111 266599 39091 50299323
Cardiac failure congestive 26.66 9.92 300 266410 84082 50254332
Epistaxis 26.33 9.92 213 266497 63741 50274673
Liver function test increased 26.33 9.92 60 266650 25546 50312868
Femur fracture 26.16 9.92 105 266605 37359 50301055
Wrong technique in product usage process 26.14 9.92 178 266532 55332 50283082
Bradypnoea 26.02 9.92 53 266657 3021 50335393
Device dislocation 26.00 9.92 46 266664 21500 50316914
Injection site warmth 25.90 9.92 21 266689 13845 50324569
Circulatory collapse 25.70 9.92 41 266669 19959 50318455
Coeliac disease 25.63 9.92 7 266703 8678 50329736
Emotional distress 25.53 9.92 247 266463 28416 50309998
Faecalith 25.51 9.92 6 266704 0 50338414
Flushing 25.44 9.92 228 266482 66787 50271627
Status epilepticus 25.42 9.92 20 266690 13386 50325028
Haematochezia 25.26 9.92 116 266594 39766 50298648
Joint stiffness 25.13 9.92 79 266631 30229 50308185
Abortion induced 24.95 9.92 9 266701 9335 50329079
Wheezing 24.93 9.92 208 266502 61839 50276575
Drug use disorder 24.87 9.92 52 266658 3020 50335394
C-reactive protein increased 24.86 9.92 227 266483 66247 50272167
Brain injury 24.85 9.92 79 266631 5935 50332479
Diabetes mellitus 24.73 9.92 154 266556 48879 50289535
Drug diversion 24.65 9.92 25 266685 740 50337674
Tongue disorder 24.52 9.92 105 266605 9111 50329303
Victim of homicide 24.08 9.92 10 266700 55 50338359
Accidental poisoning 23.78 9.92 22 266688 580 50337834
Neutropenia 23.67 9.92 596 266114 147369 50191045
Haemophagocytic lymphohistiocytosis 23.60 9.92 8 266702 8625 50329789
Anti-cyclic citrullinated peptide antibody positive 23.58 9.92 512 266198 70075 50268339
Throat irritation 23.56 9.92 81 266629 30158 50308256
Creatinine renal clearance decreased 23.46 9.92 17 266693 11864 50326550
Hepatitis 23.34 9.92 86 266624 31367 50307047
Gun shot wound 23.27 9.92 11 266699 86 50338328
Aplastic anaemia 23.13 9.92 6 266704 7697 50330717
Melaena 23.00 9.92 69 266641 26795 50311619
Spinal operation 22.98 9.92 79 266631 6181 50332233
Underdose 22.96 9.92 45 266665 20233 50318181
Multiple organ dysfunction syndrome 22.92 9.92 163 266547 50174 50288240
Transplant rejection 22.85 9.92 11 266699 9598 50328816
Infusion site pain 22.68 9.92 19 266691 12327 50326087
Sinusitis fungal 22.54 9.92 31 266679 1275 50337139
Arrhythmia 22.42 9.92 94 266616 33038 50305376
Bradycardia 22.40 9.92 224 266486 64202 50274212
Cancer pain 22.37 9.92 45 266665 2542 50335872
Alanine aminotransferase abnormal 22.37 9.92 60 266650 4096 50334318
Hyponatraemia 22.34 9.92 364 266346 95775 50242639
Oesophageal achalasia 22.20 9.92 18 266692 395 50338019
Secretion discharge 22.10 9.92 12 266698 9779 50328635
Mouth ulceration 21.88 9.92 75 266635 27949 50310465
Female genital tract fistula 21.86 9.92 55 266655 3611 50334803
Complication of device insertion 21.75 9.92 3 266707 6038 50332376
Inappropriate schedule of product administration 21.67 9.92 258 266452 71573 50266841
Hypercalcaemia 21.67 9.92 203 266507 23149 50315265
Anoxia 21.30 9.92 14 266696 219 50338195
Diffuse cutaneous mastocytosis 21.26 9.92 5 266705 0 50338414
Bronchiectasis 21.25 9.92 14 266696 10269 50328145
Injection site mass 21.25 9.92 31 266679 15649 50322765
Angina pectoris 21.19 9.92 69 266641 26119 50312295
Injection site haemorrhage 21.16 9.92 51 266659 21295 50317119
Knee arthroplasty 21.11 9.92 107 266603 35739 50302675
Injection site urticaria 21.01 9.92 20 266690 12197 50326217
Lupus-like syndrome 20.89 9.92 12 266698 9479 50328935
Product residue present 20.77 9.92 54 266656 3618 50334796
Spleen congestion 20.71 9.92 11 266699 113 50338301
Velopharyngeal incompetence 20.67 9.92 7 266703 19 50338395
Grip strength decreased 20.66 9.92 20 266690 12101 50326313
Pulmonary arterial hypertension 20.58 9.92 48 266662 20271 50318143
Failure to thrive 20.58 9.92 77 266633 6281 50332133
Paranoia 20.33 9.92 108 266602 10240 50328174
Poisoning deliberate 20.18 9.92 89 266621 7823 50330591
Caesarean section 20.15 9.92 32 266678 15607 50322807
Toxic epidermal necrolysis 20.15 9.92 51 266659 20941 50317473
Hypersomnia 20.09 9.92 144 266566 15170 50323244
Cervix neoplasm 19.91 9.92 13 266697 201 50338213
Pneumocystis jirovecii pneumonia 19.86 9.92 29 266681 14634 50323780
Orthostatic hypotension 19.72 9.92 84 266626 29397 50309017
Blood parathyroid hormone decreased 19.67 9.92 82 266628 7032 50331382
Cerebrovascular accident 19.58 9.92 366 266344 94314 50244100
Non-small cell lung cancer 19.58 9.92 46 266664 2891 50335523
Dyspnoea exertional 19.57 9.92 174 266536 51059 50287355
Disease progression 19.54 9.92 652 266058 95214 50243200
Dermatitis allergic 19.44 9.92 23 266687 12697 50325717
Allodynia 19.41 9.92 21 266689 671 50337743
Cerebral haemorrhage 19.41 9.92 75 266635 26977 50311437
Injection site induration 19.38 9.92 10 266700 8387 50330027
Tenosynovitis 19.23 9.92 108 266602 10457 50327957
Therapeutic response decreased 19.12 9.92 158 266552 47073 50291341
Injection site rash 19.10 9.92 35 266675 16142 50322272
Sickle cell anaemia with crisis 19.07 9.92 60 266650 4483 50333931
Impaired reasoning 18.97 9.92 9 266701 71 50338343
Swollen tongue 18.89 9.92 82 266628 28548 50309866
Acute kidney injury 18.83 9.92 996 265714 227062 50111352
Pain 18.81 9.92 3394 263316 575509 49762905
Uveitis 18.80 9.92 13 266697 9297 50329117
Lung cancer metastatic 18.76 9.92 39 266671 2256 50336158
Dyspepsia 18.75 9.92 276 266434 73821 50264593
Judgement impaired 18.74 9.92 19 266691 562 50337852
Presyncope 18.73 9.92 65 266645 24133 50314281
Drug ineffective for unapproved indication 18.70 9.92 54 266656 21227 50317187
Upper respiratory tract infection 18.63 9.92 240 266470 65658 50272756
Viral infection 18.52 9.92 88 266622 29898 50308516
Paraesthesia 18.52 9.92 487 266223 119756 50218658
Fluid retention 18.49 9.92 174 266536 50475 50287939
Congenital central hypoventilation syndrome 18.45 9.92 7 266703 29 50338385
Premature labour 18.35 9.92 20 266690 11456 50326958
Small intestinal obstruction 18.21 9.92 146 266564 15922 50322492
Faecaloma 18.16 9.92 80 266630 7028 50331386
Myopathy 18.14 9.92 13 266697 9126 50329288
Hallucination 18.08 9.92 346 266364 46311 50292103
Device issue 18.05 9.92 50 266660 19922 50318492
Sputum increased 18.00 9.92 34 266676 1833 50336581
Seizure 17.99 9.92 478 266232 117396 50221018
Chemical burn 17.88 9.92 15 266695 346 50338068
Anaphylactic shock 17.81 9.92 51 266659 20104 50318310
Needle issue 17.81 9.92 8 266702 7267 50331147
Breast cancer metastatic 17.60 9.92 104 266606 10260 50328154
Lip swelling 17.47 9.92 69 266641 24667 50313747
Ulcer 17.46 9.92 173 266537 20027 50318387
Encephalopathy 17.45 9.92 262 266448 33449 50304965
Pulmonary fibrosis 17.37 9.92 68 266642 24369 50314045
Haematotoxicity 17.35 9.92 10 266700 7885 50330529
Snake bite 17.34 9.92 5 266705 6 50338408
Hypotension 17.32 9.92 1040 265670 234429 50103985
Blood pressure fluctuation 17.30 9.92 114 266596 35709 50302705
Smear cervix abnormal 17.27 9.92 42 266668 2699 50335715
Myoclonus 17.24 9.92 133 266577 14337 50324077
Immune reconstitution inflammatory syndrome 17.14 9.92 4 266706 5512 50332902
Gait disturbance 17.14 9.92 632 266078 149373 50189041
Gestational diabetes 17.07 9.92 9 266701 7456 50330958
Drug-induced liver injury 17.04 9.92 83 266627 28012 50310402
Clear cell renal cell carcinoma 17.03 9.92 26 266684 1177 50337237
Paranoid personality disorder 17.00 9.92 4 266706 0 50338414
Colitis ulcerative 16.92 9.92 40 266670 16814 50321600
Learning disability 16.91 9.92 12 266698 214 50338200
Panniculitis 16.88 9.92 89 266621 8414 50330000
Haemorrhage 16.88 9.92 190 266520 53251 50285163
Mandibular mass 16.79 9.92 11 266699 171 50338243
Cardiotoxicity 16.78 9.92 8 266702 7019 50331395
Pneumonia viral 16.77 9.92 76 266634 6758 50331656
Glaucoma 16.75 9.92 36 266674 15650 50322764
Sedation complication 16.72 9.92 13 266697 8753 50329661
Electrocardiogram QT prolonged 16.57 9.92 184 266526 51702 50286712
Euphoric mood 16.51 9.92 53 266657 4002 50334412
Central nervous system stimulation 16.38 9.92 6 266704 22 50338392
Gallbladder disorder 16.27 9.92 147 266563 16595 50321819
Extrapyramidal disorder 16.22 9.92 23 266687 11747 50326667
Hip arthroplasty 16.17 9.92 94 266616 30335 50308079
Granuloma skin 16.04 9.92 67 266643 5751 50332663
Splenic injury 16.00 9.92 11 266699 186 50338228
Device breakage 15.99 9.92 16 266694 9531 50328883
Nasal polyps 15.95 9.92 39 266671 2515 50335899
Myelodysplastic syndrome 15.93 9.92 35 266675 15097 50323317
Cognitive disorder 15.93 9.92 152 266558 43971 50294443
Therapeutic product effect increased 15.88 9.92 23 266687 993 50337421
Granulocytopenia 15.85 9.92 4 266706 5227 50333187
Eye pruritus 15.82 9.92 26 266684 12508 50325906
Renal impairment 15.79 9.92 292 266418 75369 50263045
Inflammatory marker increased 15.79 9.92 5 266705 5629 50332785
Tuberculosis 15.66 9.92 18 266692 10065 50328349
COVID-19 pneumonia 15.33 9.92 13 266697 8382 50330032
Urinary tract infection 15.16 9.92 997 265713 223023 50115391
Drug hypersensitivity 15.07 9.92 1527 265183 249483 50088931
Hepatotoxicity 15.06 9.92 83 266627 27143 50311271
Acne 14.92 9.92 53 266657 19542 50318872
Performance enhancing product use 14.92 9.92 5 266705 13 50338401
Spinal cord operation 14.78 9.92 4 266706 3 50338411
Malignant melanoma 14.69 9.92 19 266691 10089 50328325
Gastrointestinal haemorrhage 14.68 9.92 285 266425 73036 50265378
Post laminectomy syndrome 14.64 9.92 11 266699 215 50338199
Unintended pregnancy 14.57 9.92 4 266706 4942 50333472
Rash pustular 14.55 9.92 8 266702 6473 50331941
Metastases to bone 14.54 9.92 152 266558 17843 50320571
Cyst 14.51 9.92 112 266598 12075 50326339
Blood potassium increased 14.45 9.92 141 266569 16257 50322157
Respiratory tract infection 14.42 9.92 104 266606 31913 50306501
Blood glucose increased 14.35 9.92 277 266433 71047 50267367
Ileus 14.35 9.92 119 266591 13110 50325304
Pulmonary infarction 14.32 9.92 36 266674 2362 50336052
Foreign body embolism 14.25 9.92 4 266706 4 50338410
Dental caries 14.25 9.92 95 266615 9772 50328642
Progressive multifocal leukoencephalopathy 14.24 9.92 24 266686 11433 50326981
Demyelination 14.18 9.92 7 266703 6019 50332395
Embolism venous 14.14 9.92 37 266673 2488 50335926
Drug tolerance increased 14.14 9.92 11 266699 227 50338187
Sinus disorder 14.01 9.92 50 266660 18408 50320006
Bone density decreased 13.95 9.92 23 266687 11052 50327362
Proteinuria 13.94 9.92 43 266667 16554 50321860
Renal failure 13.86 9.92 442 266268 106191 50232223
Cystitis 13.85 9.92 159 266551 44405 50294009
Eosinophilia 13.84 9.92 51 266659 18601 50319813
Interstitial lung disease 13.83 9.92 197 266513 52979 50285435
Pneumonia aspiration 13.80 9.92 235 266475 30769 50307645
Foetal growth restriction 13.72 9.92 9 266701 6618 50331796
Pemphigoid 13.69 9.92 7 266703 5900 50332514
Ischaemic stroke 13.62 9.92 41 266669 15907 50322507
Low birth weight baby 13.58 9.92 7 266703 5874 50332540
Maternal exposure timing unspecified 13.56 9.92 46 266664 3574 50334840
Atrioventricular block complete 13.53 9.92 11 266699 7244 50331170
Hallucination, synaesthetic 13.50 9.92 6 266704 40 50338374
Oesophageal obstruction 13.49 9.92 14 266696 426 50337988
Rash erythematous 13.47 9.92 118 266592 34734 50303680
Septic shock 13.43 9.92 216 266494 56959 50281455
Hypertensive crisis 13.38 9.92 31 266679 13123 50325291
Mucosal inflammation 13.36 9.92 141 266569 40001 50298413
Respiratory acidosis 13.30 9.92 65 266645 5963 50332451
Oral herpes 13.29 9.92 60 266650 20665 50317749
Injection site extravasation 13.23 9.92 12 266698 7489 50330925
Hypercholesterolaemia 13.22 9.92 26 266684 11677 50326737
Food allergy 13.21 9.92 14 266696 8123 50330291
Agranulocytosis 13.15 9.92 63 266647 21358 50317056
Respiratory symptom 13.14 9.92 35 266675 2379 50336035
Hypoventilation 13.12 9.92 48 266662 3873 50334541
Multiple sclerosis relapse 13.08 9.92 154 266556 42810 50295604
Complication of device removal 12.98 9.92 3 266707 4161 50334253
Radiculopathy 12.92 9.92 56 266654 4885 50333529
Gastroenteritis 12.86 9.92 71 266639 23210 50315204
Therapeutic response shortened 12.82 9.92 12 266698 7377 50331037
Balance disorder 12.76 9.92 279 266431 70311 50268103
Hypertension neonatal 12.75 9.92 3 266707 0 50338414
Cardiogenic shock 12.69 9.92 41 266669 15558 50322856
Stress cardiomyopathy 12.66 9.92 78 266632 7809 50330605
Ischaemic hepatitis 12.63 9.92 30 266680 1899 50336515
Hypomania 12.62 9.92 4 266706 4501 50333913
Synovitis 12.59 9.92 785 265925 123080 50215334
Breakthrough pain 12.58 9.92 22 266688 1117 50337297
Epstein-Barr virus infection 12.57 9.92 11 266699 6986 50331428
Pelvic venous thrombosis 12.50 9.92 24 266686 1310 50337104
Osteoporosis 12.48 9.92 164 266546 44715 50293699
Parkinsonism 12.48 9.92 17 266693 8830 50329584
Ventricular septal defect 12.42 9.92 3 266707 4038 50334376
Loss of personal independence in daily activities 12.34 9.92 278 266432 69772 50268642
Diastolic hypotension 12.32 9.92 7 266703 83 50338331
Breathing-related sleep disorder 12.32 9.92 7 266703 83 50338331
Jaundice 12.31 9.92 85 266625 26344 50312070
Nystagmus 12.29 9.92 7 266703 5554 50332860
Product storage error 12.28 9.92 29 266681 12195 50326219
Ocular hyperaemia 12.27 9.92 60 266650 20232 50318182
Rectal haemorrhage 12.21 9.92 137 266573 38421 50299993
Dehydration 12.16 9.92 947 265763 151502 50186912
Obsessive-compulsive disorder 12.13 9.92 42 266668 3298 50335116
Colitis microscopic 12.02 9.92 10 266700 6510 50331904
Torsade de pointes 11.95 9.92 28 266682 11807 50326607
Swelling face 11.93 9.92 200 266510 52395 50286019
Photosensitivity reaction 11.91 9.92 32 266678 12879 50325535
Stool analysis abnormal 11.79 9.92 6 266704 56 50338358
Neoplasm malignant 11.77 9.92 183 266527 23532 50314882
Tachycardia 11.69 9.92 419 266291 99344 50239070
Leukopenia neonatal 11.68 9.92 5 266705 30 50338384
Renal mass 11.67 9.92 29 266681 1889 50336525
Stevens-Johnson syndrome 11.66 9.92 67 266643 21685 50316729
Sleep disorder due to a general medical condition 11.62 9.92 13 266697 7358 50331056
Central nervous system injury 11.60 9.92 8 266702 136 50338278
Spinal nerve stimulator implantation 11.57 9.92 7 266703 94 50338320
Impaired quality of life 11.53 9.92 9 266701 6047 50332367
Compression fracture 11.52 9.92 61 266649 5776 50332638
Nail disorder 11.47 9.92 21 266689 9687 50328727
Patent ductus arteriosus 11.42 9.92 3 266707 3817 50334597
Glomerular filtration rate decreased 11.42 9.92 28 266682 11624 50326790
Spinal fracture 11.41 9.92 129 266581 15444 50322970
Coccydynia 11.39 9.92 22 266688 1206 50337208
Back disorder 11.35 9.92 86 266624 9219 50329195
Injection site discolouration 11.32 9.92 12 266698 6962 50331452
Skin plaque 11.31 9.92 10 266700 6318 50332096
Post procedural pulmonary embolism 11.28 9.92 10 266700 249 50338165
Blood creatine phosphokinase MB increased 11.26 9.92 21 266689 1121 50337293
Rash 11.24 9.92 2536 264174 434935 49903479
Sinus congestion 11.17 9.92 37 266673 13934 50324480
Hypothalamic pituitary adrenal axis suppression 11.16 9.92 8 266702 145 50338269
Tonsillitis 11.16 9.92 6 266704 4917 50333497
Cardiovascular disorder 11.15 9.92 24 266686 10430 50327984
Device use error 11.11 9.92 7 266703 5259 50333155
Bedridden 11.10 9.92 86 266624 9281 50329133
Systemic lupus erythematosus 11.06 9.92 617 266093 140005 50198409
Fibromyalgia 11.05 9.92 313 266397 44665 50293749
Anhedonia 11.05 9.92 87 266623 9437 50328977
Genital haemorrhage 11.03 9.92 11 266699 6563 50331851
Urine abnormality 10.98 9.92 10 266700 6228 50332186
Aspiration 10.95 9.92 85 266625 9179 50329235
Acute myocardial infarction 10.93 9.92 100 266610 29173 50309241
Muscular weakness 10.91 9.92 400 266310 94613 50243801
Aspergillus infection 10.78 9.92 12 266698 6809 50331605
Breast cancer 10.76 9.92 160 266550 42730 50295684
Gamma-glutamyltransferase increased 10.71 9.92 102 266608 29521 50308893
Venous recanalisation 10.69 9.92 3 266707 3 50338411
Opiates positive 10.67 9.92 11 266699 332 50338082
Atelectasis 10.65 9.92 145 266565 18125 50320289
Dermatitis exfoliative 10.63 9.92 7 266703 5135 50333279
Depression 10.59 9.92 1011 265699 164412 50174002
Gallbladder injury 10.59 9.92 22 266688 1272 50337142
Gingival bleeding 10.57 9.92 28 266682 11325 50327089
Emphysema 10.51 9.92 83 266627 9010 50329404
Skin cancer 10.50 9.92 21 266689 9373 50329041
Intercepted product prescribing error 10.50 9.92 8 266702 160 50338254
Septic pulmonary embolism 10.48 9.92 5 266705 40 50338374
Diverticulitis 10.46 9.92 118 266592 33064 50305350
Hypervolaemia 10.46 9.92 85 266625 25414 50313000
Intentional self-injury 10.44 9.92 75 266635 23037 50315377
Transaminases increased 10.41 9.92 95 266615 27729 50310685
Suicide attempt 10.38 9.92 201 266509 51531 50286883
Sputum discoloured 10.35 9.92 36 266674 13359 50325055
Skin necrosis 10.35 9.92 95 266615 10772 50327642
Rash papular 10.34 9.92 33 266677 12571 50325843
Drug withdrawal syndrome neonatal 10.34 9.92 27 266683 1814 50336600
Fungal oesophagitis 10.32 9.92 14 266696 568 50337846
Hysterectomy 10.24 9.92 74 266636 7816 50330598
Fear of injection 10.21 9.92 61 266649 6042 50332372
Infusion site erythema 10.20 9.92 19 266691 8708 50329706
Conjunctivitis 10.20 9.92 47 266663 16098 50322316
Pathogen resistance 10.15 9.92 9 266701 5680 50332734
Pancreatic carcinoma recurrent 10.15 9.92 6 266704 77 50338337
Leukoencephalopathy 10.15 9.92 44 266666 3839 50334575
Bronchospasm 10.14 9.92 42 266668 14812 50323602
Brain scan abnormal 10.08 9.92 10 266700 288 50338126
Joint destruction 10.08 9.92 4 266706 3912 50334502
Bone marrow failure 10.04 9.92 95 266615 27529 50310885
Poor venous access 10.02 9.92 25 266685 10315 50328099
Mastocytosis 10.00 9.92 13 266697 506 50337908
Therapy partial responder 9.98 9.92 12 266698 6579 50331835
Depressed mood 9.96 9.92 123 266587 33900 50304514
Alcohol use 9.94 9.92 28 266682 1967 50336447

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
Drug abuse 2245.84 10.55 2566 173622 77317 29321022
Drug abuser 2092.23 10.55 806 175382 3021 29395318
Drug dependence 1763.83 10.55 1253 174935 19728 29378611
Respiratory arrest 860.95 10.55 909 175279 24924 29373415
Toxicity to various agents 826.41 10.55 2588 173600 171073 29227266
Drug withdrawal syndrome 796.41 10.55 739 175449 17245 29381094
Overdose 742.56 10.55 1535 174653 78284 29320055
Accidental overdose 729.37 10.55 697 175491 16896 29381443
Completed suicide 694.58 10.55 1608 174580 88638 29309701
Substance abuse 634.55 10.55 433 175755 6354 29391985
Inadequate analgesia 578.43 10.55 293 175895 2361 29395978
Intentional product misuse 322.18 10.55 667 175521 33994 29364345
Cardio-respiratory arrest 281.98 10.55 799 175389 49802 29348537
Off label use 277.93 10.55 895 175293 299905 29098434
Delirium 262.80 10.55 665 175523 38732 29359607
Poisoning 251.38 10.55 304 175884 9689 29388650
Cardiac arrest 234.62 10.55 1071 175117 84520 29313819
Constipation 225.40 10.55 1303 174885 112857 29285482
Respiratory depression 224.58 10.55 336 175852 13187 29385152
Malignant neoplasm progression 198.50 10.55 919 175269 72940 29325399
Miosis 190.69 10.55 237 175951 7772 29390567
Death 183.69 10.55 2956 173232 339128 29059211
Drug screen positive 169.70 10.55 157 176031 3644 29394695
Somnolence 161.59 10.55 1035 175153 92920 29305419
Product use in unapproved indication 159.75 10.55 169 176019 86706 29311633
Drug tolerance 156.72 10.55 118 176070 2035 29396304
Nausea 145.91 10.55 2475 173713 286780 29111559
Accidental death 145.19 10.55 112 176076 2006 29396333
Gun shot wound 137.91 10.55 84 176104 1001 29397338
Unresponsive to stimuli 133.32 10.55 390 175798 24736 29373603
Plasma cell myeloma 126.05 10.55 496 175692 36619 29361720
Toxic leukoencephalopathy 114.77 10.55 48 176140 233 29398106
Coma 110.43 10.55 497 175691 38953 29359386
Mental status changes 110.03 10.55 456 175732 34471 29363868
C-reactive protein abnormal 105.09 10.55 160 176028 6376 29391963
Exposure via ingestion 103.22 10.55 90 176098 1928 29396411
Drug ineffective 94.05 10.55 1561 174627 361609 29036730
Cytomegalovirus infection 83.64 10.55 18 176170 23197 29375142
Cardiac failure 82.91 10.55 222 175966 79065 29319274
Foetal exposure during pregnancy 79.32 10.55 52 176136 33815 29364524
Narcotic bowel syndrome 78.11 10.55 30 176158 111 29398228
Drug use disorder 77.85 10.55 99 176089 3323 29395016
Drug interaction 75.75 10.55 781 175407 196604 29201735
Confusional state 74.58 10.55 1122 175066 126755 29271584
Drug resistance 73.07 10.55 19 176169 21521 29376818
Hyperaesthesia 72.12 10.55 96 176092 3373 29394966
Sedation 67.70 10.55 243 175945 17162 29381177
Lactic acidosis 67.44 10.55 49 176139 30198 29368141
Product use issue 64.22 10.55 131 176057 51313 29347026
Road traffic accident 63.75 10.55 221 175967 15340 29382999
Withdrawal syndrome 62.54 10.55 175 176013 10817 29387522
Vomiting 62.30 10.55 1680 174508 210580 29187759
Drug reaction with eosinophilia and systemic symptoms 60.28 10.55 47 176141 27945 29370394
Cough 59.63 10.55 476 175712 126251 29272088
Drug tolerance increased 59.24 10.55 36 176152 427 29397912
Angioedema 58.70 10.55 62 176126 31853 29366486
Acute kidney injury 57.27 10.55 1176 175012 264091 29134248
Respiratory rate decreased 56.97 10.55 64 176124 1881 29396458
Depressed level of consciousness 56.79 10.55 396 175792 36546 29361793
Anxiety 56.50 10.55 766 175422 84599 29313740
Cardiogenic shock 56.09 10.55 22 176166 19168 29379171
Hyperhidrosis 54.79 10.55 607 175581 63933 29334406
Toxicologic test abnormal 54.59 10.55 36 176152 497 29397842
Paroxysmal sympathetic hyperactivity 54.11 10.55 16 176172 18 29398321
Product complaint 53.71 10.55 107 176081 5298 29393041
Leukopenia 52.95 10.55 161 176027 55042 29343297
Toxic epidermal necrolysis 52.75 10.55 21 176167 18132 29380207
Dependence 52.61 10.55 46 176142 989 29397350
Neuroleptic malignant syndrome 51.52 10.55 16 176172 16132 29382207
Depression 51.50 10.55 752 175436 84395 29313944
Delusional disorder, unspecified type 51.27 10.55 38 176150 639 29397700
Back pain 50.43 10.55 873 175315 101411 29296928
Lethargy 49.87 10.55 389 175799 37191 29361148
Asthma 49.61 10.55 78 176110 33771 29364568
Epilepsy 49.33 10.55 24 176164 18408 29379931
Therapeutic product effect incomplete 49.13 10.55 100 176088 39205 29359134
Terminal state 47.19 10.55 79 176109 3415 29394924
Bradycardia 46.90 10.55 216 175972 65413 29332926
Bradypnoea 46.83 10.55 64 176124 2307 29396032
Enthesopathy 45.79 10.55 81 176107 3662 29394677
Cancer pain 44.33 10.55 62 176126 2285 29396054
Eosinophilia 44.28 10.55 40 176148 22121 29376218
Neutropenia 43.42 10.55 539 175649 131172 29267167
Condition aggravated 42.67 10.55 614 175574 145681 29252658
Incorrect route of product administration 42.17 10.55 151 176037 10650 29387689
Tenosynovitis 42.13 10.55 78 176110 3655 29394684
Cerebral haemorrhage 41.84 10.55 77 176111 31349 29366990
Atrial fibrillation 41.68 10.55 415 175773 105231 29293108
Breakthrough pain 39.81 10.55 30 176158 518 29397821
Disease progression 39.58 10.55 697 175491 81219 29317120
Foreign body reaction 38.65 10.55 14 176174 42 29398297
Acute myocardial infarction 38.54 10.55 153 176035 48285 29350054
Injection site pain 38.50 10.55 85 176103 32361 29365978
Substance dependence 38.42 10.55 25 176163 337 29398002
Melaena 38.38 10.55 80 176108 31096 29367243
Hypoglycaemia 38.28 10.55 153 176035 48193 29350146
Accident 37.84 10.55 74 176114 3614 29394725
Cardiac failure congestive 37.22 10.55 285 175903 76296 29322043
Drug diversion 37.03 10.55 34 176154 781 29397558
Renal impairment 36.62 10.55 309 175879 81024 29317315
Decreased appetite 35.33 10.55 1124 175064 144218 29254121
Drug hypersensitivity 34.83 10.55 587 175601 67819 29330520
Spinal fracture 34.70 10.55 101 176087 6385 29391954
Syncope 34.49 10.55 314 175874 81057 29317282
Product dose omission issue 34.21 10.55 388 175800 95995 29302344
Labelled drug-drug interaction medication error 33.83 10.55 15 176173 12144 29386195
Piloerection 33.65 10.55 17 176171 136 29398203
Neoplasm malignant 33.16 10.55 193 175995 16732 29381607
Self-medication 32.21 10.55 51 176137 2103 29396236
Angina pectoris 32.19 10.55 74 176114 27776 29370563
Pulmonary thrombosis 32.07 10.55 99 176089 6466 29391873
Apparent death 32.01 10.55 67 176121 3437 29394902
Impaired driving ability 31.88 10.55 53 176135 2278 29396061
Seizure 31.84 10.55 378 175810 92745 29305594
COVID-19 31.77 10.55 109 176079 35905 29362434
Bone pain 31.47 10.55 203 175985 18249 29380090
Sopor 31.20 10.55 13 176175 10921 29387418
Aspergillus infection 31.14 10.55 12 176176 10569 29387770
Proteinuria 31.01 10.55 29 176159 15775 29382564
Thrombocytopenia 30.40 10.55 593 175595 134230 29264109
Drug detoxification 30.36 10.55 17 176171 171 29398168
Drug screen negative 30.18 10.55 16 176172 143 29398196
Neoplasm progression 30.07 10.55 202 175986 18410 29379929
Pain 30.04 10.55 1278 174910 170154 29228185
Pathogen resistance 29.84 10.55 6 176182 8110 29390229
Apnoea 29.79 10.55 92 176096 6010 29392329
Transplant rejection 29.61 10.55 9 176179 9203 29389136
Tongue disorder 29.58 10.55 77 176111 4559 29393780
Psoriasis 29.48 10.55 96 176092 32131 29366208
Circulatory collapse 29.33 10.55 41 176147 18632 29379707
Respiratory tract infection 29.23 10.55 30 176158 15621 29382718
Intervertebral disc degeneration 29.15 10.55 83 176105 5181 29393158
Alanine aminotransferase abnormal 28.74 10.55 58 176130 2899 29395440
Myelosuppression 28.32 10.55 19 176169 12208 29386131
Product formulation issue 27.98 10.55 23 176165 453 29397886
Agranulocytosis 27.82 10.55 49 176139 20291 29378048
Sinus tachycardia 27.70 10.55 169 176019 14900 29383439
Weight increased 27.45 10.55 308 175880 76359 29321980
Compartment syndrome 27.38 10.55 51 176137 2401 29395938
Intestinal sepsis 27.34 10.55 22 176166 420 29397919
Toxic skin eruption 27.20 10.55 12 176176 9745 29388594
Deafness neurosensory 26.78 10.55 52 176136 2526 29395813
Nasopharyngitis 26.70 10.55 227 175961 59438 29338901
Joint arthroplasty 26.52 10.55 26 176162 650 29397689
Compression fracture 26.45 10.55 53 176135 2635 29395704
Hepatotoxicity 26.34 10.55 41 176147 17826 29380513
Emotional distress 26.29 10.55 157 176031 13738 29384601
Septic shock 26.24 10.55 242 175946 62318 29336021
Medication error 26.19 10.55 216 175972 20995 29377344
Gastrointestinal haemorrhage 25.98 10.55 326 175862 79207 29319132
Deep vein thrombosis 25.47 10.55 482 175706 56917 29341422
Pulmonary embolism 25.36 10.55 616 175572 75918 29322421
Thrombosis 25.15 10.55 378 175810 42667 29355672
Pupillary reflex impaired 24.81 10.55 36 176152 1373 29396966
Pulmonary congestion 24.48 10.55 142 176046 12294 29386045
Immune reconstitution inflammatory syndrome 24.41 10.55 8 176180 7794 29390545
Rib fracture 24.25 10.55 144 176044 12574 29385765
Serotonin syndrome 24.18 10.55 183 176005 17329 29381010
Glomerular filtration rate decreased 24.15 10.55 19 176169 11247 29387092
Hepatic pain 24.09 10.55 33 176155 1192 29397147
Colitis ulcerative 23.26 10.55 25 176163 12744 29385595
Agitation 23.17 10.55 432 175756 50872 29347467
Myocardial infarction 23.10 10.55 491 175697 109805 29288534
Post laminectomy syndrome 23.04 10.55 14 176174 166 29398173
Infusion related reaction 22.91 10.55 160 176028 43726 29354613
Pancreatitis acute 22.75 10.55 72 176116 24313 29374026
Ventricular fibrillation 22.71 10.55 37 176151 15796 29382543
Diabetic ketoacidosis 22.64 10.55 38 176150 16035 29382304
Device issue 22.60 10.55 9 176179 7771 29390568
Dehydration 22.51 10.55 866 175322 113882 29284457
Tooth loss 22.40 10.55 60 176128 3614 29394725
Nervousness 22.20 10.55 129 176059 11177 29387162
Alcohol use 22.05 10.55 54 176134 3078 29395261
Cerebrovascular accident 21.96 10.55 324 175864 76587 29321752
Victim of homicide 21.92 10.55 12 176176 115 29398224
Tachyphylaxis 21.88 10.55 11 176177 87 29398252
Nasal necrosis 21.80 10.55 9 176179 42 29398297
Metastatic renal cell carcinoma 21.79 10.55 40 176148 1862 29396477
Hypoaesthesia 21.70 10.55 443 175745 53024 29345315
Cardiac failure acute 21.67 10.55 14 176174 9178 29389161
Premature baby 21.55 10.55 44 176144 17236 29381103
Chronic kidney disease 21.43 10.55 128 176060 36288 29362051
Back injury 21.34 10.55 57 176131 3427 29394912
Injection site swelling 21.32 10.55 15 176173 9402 29388937
Blood pressure decreased 21.26 10.55 171 176017 45306 29353033
Postmortem blood drug level abnormal 21.10 10.55 16 176172 279 29398060
Lower respiratory tract infection 20.89 10.55 84 176104 26418 29371921
Pruritus 20.88 10.55 533 175655 116316 29282023
Multiple organ dysfunction syndrome 20.87 10.55 258 175930 62858 29335481
Aptyalism 20.81 10.55 16 176172 285 29398054
Nephropathy toxic 20.80 10.55 20 176168 10736 29387603
Lip swelling 20.77 10.55 26 176162 12384 29385955
Arthropathy 20.75 10.55 208 175980 21346 29376993
Anaemia 20.74 10.55 982 175206 199969 29198370
Pathological fracture 20.59 10.55 60 176128 3795 29394544
Drug eruption 20.57 10.55 43 176145 16698 29381641
Feeling abnormal 20.44 10.55 446 175742 53999 29344340
Myalgia 20.38 10.55 314 175874 73705 29324634
Opiates positive 20.33 10.55 20 176168 502 29397837
Post transplant lymphoproliferative disorder 20.32 10.55 4 176184 5489 29392850
Cerebral infarction 20.22 10.55 77 176111 24598 29373741
Brain death 20.14 10.55 44 176144 2326 29396013
Venoocclusive liver disease 20.10 10.55 8 176180 6909 29391430
Schizophrenia 20.07 10.55 7 176181 6558 29391781
Acute graft versus host disease 20.01 10.55 5 176183 5819 29392520
Epistaxis 20.00 10.55 204 175984 51500 29346839
Tuberculosis 19.82 10.55 9 176179 7187 29391152
Bone marrow failure 19.80 10.55 90 176098 27359 29370980
Cardiac failure chronic 19.59 10.55 7 176181 6460 29391879
Drug-induced liver injury 19.46 10.55 65 176123 21590 29376749
Diabetes mellitus 19.45 10.55 148 176040 39683 29358656
Thermophobia 19.31 10.55 9 176179 59 29398280
Eczema 19.19 10.55 33 176155 13793 29384546
Hyperkalaemia 19.17 10.55 254 175934 61138 29337201
Loss of consciousness 19.09 10.55 577 175611 73479 29324860
Troponin T increased 19.09 10.55 32 176156 1385 29396954
Blood pressure fluctuation 19.08 10.55 58 176130 19836 29378503
Ileus 19.05 10.55 149 176039 14253 29384086
Exposure during pregnancy 18.88 10.55 14 176174 8540 29389799
Parkinsonism 18.69 10.55 10 176178 7268 29391071
Artery dissection 18.62 10.55 10 176178 92 29398247
Dental caries 18.56 10.55 61 176127 4119 29394220
Bronchiectasis 18.51 10.55 8 176180 6577 29391762
BK virus infection 18.34 10.55 3 176185 4704 29393635
Aplasia pure red cell 18.32 10.55 5 176183 5486 29392853
Signet-ring cell carcinoma 18.31 10.55 5 176183 3 29398336
Aplastic anaemia 18.31 10.55 11 176177 7499 29390840
Poisoning deliberate 18.17 10.55 75 176113 5656 29392683
Blood creatinine increased 18.06 10.55 378 175810 84724 29313615
Environmental exposure 18.04 10.55 14 176174 253 29398086
Neutrophil count increased 18.00 10.55 38 176150 14704 29383635
Hypersensitivity 17.97 10.55 215 175973 52688 29345651
Atrial septal defect 17.92 10.55 9 176179 6780 29391559
Pseudarthrosis 17.92 10.55 9 176179 71 29398268
Basal cell carcinoma 17.92 10.55 47 176141 16863 29381476
Pyrexia 17.89 10.55 1473 174715 286149 29112190
Atrioventricular block complete 17.82 10.55 13 176175 7998 29390341
Disease recurrence 17.82 10.55 43 176145 15871 29382468
Rhabdomyolysis 17.76 10.55 255 175933 60553 29337786
Jaundice 17.76 10.55 102 176086 29194 29369145
Myelodysplastic syndrome 17.70 10.55 51 176137 17743 29380596
Dizziness 17.62 10.55 937 175251 188747 29209592
Spinal cord ischaemia 17.61 10.55 9 176179 74 29398265
Decreased gait velocity 17.51 10.55 11 176177 139 29398200
Acute coronary syndrome 17.49 10.55 29 176159 12296 29386043
Blood triglycerides increased 17.48 10.55 31 176157 12803 29385536
Shock 17.41 10.55 67 176121 21337 29377002
Spinal operation 17.40 10.55 42 176146 2372 29395967
Granulocytopenia 17.31 10.55 7 176181 5987 29392352
Pemphigoid 17.26 10.55 12 176176 7569 29390770
Formication 17.15 10.55 32 176156 1508 29396831
Progressive multifocal leukoencephalopathy 17.11 10.55 16 176172 8703 29389636
Bone disorder 17.03 10.55 74 176114 5709 29392630
Tumour pain 17.01 10.55 24 176164 892 29397447
Adenovirus infection 16.96 10.55 3 176185 4444 29393895
Metastases to spine 16.92 10.55 39 176149 2137 29396202
Interstitial lung disease 16.89 10.55 457 175731 57261 29341078
Spinal fusion surgery 16.89 10.55 23 176165 826 29397513
Hypogammaglobulinaemia 16.89 10.55 7 176181 5900 29392439
Coronary artery disease 16.82 10.55 175 176013 44015 29354324
Urinary retention 16.69 10.55 275 175913 31623 29366716
Mucormycosis 16.65 10.55 5 176183 5153 29393186
Bronchopulmonary aspergillosis 16.65 10.55 30 176158 12314 29386025
Stevens-Johnson syndrome 16.62 10.55 47 176141 16450 29381889
Metabolic encephalopathy 16.54 10.55 54 176134 3633 29394706
Non-small cell lung cancer 16.50 10.55 47 176141 2934 29395405
Spinal laminectomy 16.38 10.55 13 176175 243 29398096
Eosinophil count increased 16.34 10.55 12 176176 7357 29390982
Sickle cell anaemia with crisis 16.31 10.55 43 176145 2565 29395774
Cholestasis 16.29 10.55 78 176110 23384 29374955
Hypophagia 16.21 10.55 193 175995 20679 29377660
Injection site erythema 16.19 10.55 37 176151 13919 29384420
Inappropriate schedule of product administration 16.17 10.55 178 176010 44294 29354045
Cerebral haematoma 16.16 10.55 3 176185 4293 29394046
Allodynia 15.99 10.55 19 176169 594 29397745
Hypoxic-ischaemic encephalopathy 15.97 10.55 59 176129 4225 29394114
Electrocardiogram QT prolonged 15.93 10.55 138 176050 35999 29362340
Learning disability 15.90 10.55 14 176174 304 29398035
Hypertensive crisis 15.88 10.55 14 176174 7834 29390505
Insomnia 15.80 10.55 663 175525 88098 29310241
Hypercalcaemia 15.79 10.55 130 176058 12629 29385710
Anaphylactic shock 15.76 10.55 35 176153 13301 29385038
Metastases to bone 15.73 10.55 107 176081 9791 29388548
Upper gastrointestinal haemorrhage 15.71 10.55 72 176116 21842 29376497
Myoclonus 15.61 10.55 134 176054 13175 29385164
Small intestinal obstruction 15.59 10.55 132 176056 12929 29385410
Hypertensive heart disease 15.55 10.55 37 176151 2070 29396269
Hypertriglyceridaemia 15.53 10.55 13 176175 7462 29390877
Red blood cell sedimentation rate abnormal 15.47 10.55 39 176149 2264 29396075
Renal cell carcinoma 15.32 10.55 62 176126 4634 29393705
Ventricular tachycardia 15.12 10.55 76 176112 22498 29375841
Blood pressure increased 15.02 10.55 330 175858 73473 29324866
Dyspnoea 15.02 10.55 1711 174477 325021 29073318
Near death experience 14.95 10.55 8 176180 73 29398266
Kidney transplant rejection 14.78 10.55 12 176176 6993 29391346
Influenza virus test positive 14.76 10.55 8 176180 75 29398264
Haematuria 14.75 10.55 180 176008 43959 29354380
Irritability 14.72 10.55 199 175989 21953 29376386
Mania 14.65 10.55 18 176170 8645 29389694
Lumbar radiculopathy 14.63 10.55 20 176168 721 29397618
Delirium tremens 14.62 10.55 17 176171 519 29397820
Snoring 14.55 10.55 43 176145 2741 29395598
Subarachnoid haemorrhage 14.52 10.55 22 176166 9670 29388669
Myocarditis 14.44 10.55 27 176161 10929 29387410
Productive cough 14.40 10.55 118 176070 31141 29367198
Injection site reaction 14.37 10.55 28 176160 11160 29387179
Sarcopenia 14.34 10.55 14 176174 348 29397991
Graft versus host disease 14.28 10.55 22 176166 9606 29388733
Lymphadenopathy 14.24 10.55 89 176099 24960 29373379
Transaminases increased 14.22 10.55 78 176110 22584 29375755
Acute graft versus host disease in skin 14.21 10.55 5 176183 4659 29393680
Suicidal ideation 14.20 10.55 288 175900 34428 29363911
Gamma-glutamyltransferase increased 14.19 10.55 97 176091 26640 29371699
Yawning 14.14 10.55 16 176172 474 29397865
Dyspnoea exertional 14.09 10.55 144 176044 36346 29361993
Chest discomfort 14.08 10.55 191 175997 45792 29352547
Drug withdrawal maintenance therapy 14.08 10.55 8 176180 83 29398256
Concomitant disease aggravated 14.07 10.55 6 176182 4972 29393367
Failure to anastomose 13.94 10.55 11 176177 204 29398135
COVID-19 pneumonia 13.89 10.55 22 176166 9500 29388839
Lumbar vertebral fracture 13.85 10.55 32 176156 1756 29396583
Aspiration 13.84 10.55 106 176082 10074 29388265
Vestibular ischaemia 13.80 10.55 5 176183 15 29398324
Haemophagocytic lymphohistiocytosis 13.75 10.55 26 176162 10478 29387861
Ejection fraction decreased 13.66 10.55 49 176139 15929 29382410
Generalised tonic-clonic seizure 13.65 10.55 63 176125 19076 29379263
Brain injury 13.62 10.55 67 176121 5445 29392894
Acute hepatic failure 13.61 10.55 32 176156 11920 29386419
Glycosylated haemoglobin increased 13.54 10.55 22 176166 9404 29388935
Eyelid ptosis 13.50 10.55 7 176181 5179 29393160
Decubitus ulcer 13.44 10.55 82 176106 7229 29391110
Foetal growth restriction 13.40 10.55 3 176185 3763 29394576
Intervertebral disc protrusion 13.35 10.55 93 176095 8577 29389762
Intentional overdose 13.33 10.55 312 175876 38216 29360123
Bronchospasm 13.28 10.55 23 176165 9586 29388753
Tendonitis 13.22 10.55 87 176101 7874 29390465
Rash 13.20 10.55 963 175225 188856 29209483
Musculoskeletal stiffness 13.19 10.55 151 176037 37307 29361032
Atelectasis 13.15 10.55 145 176043 15247 29383092
Gastric haemorrhage 13.08 10.55 22 176166 9275 29389064
Swollen tongue 13.06 10.55 34 176154 12232 29386107
Haematochezia 13.06 10.55 149 176039 36834 29361505
Neutrophilia 12.89 10.55 3 176185 3663 29394676
Disturbance in attention 12.84 10.55 189 175999 21235 29377104
Androgen deficiency 12.78 10.55 10 176178 183 29398156
Pupil fixed 12.75 10.55 30 176158 1666 29396673
Anaphylactic reaction 12.74 10.55 104 176084 27469 29370870
Product prescribing issue 12.69 10.55 24 176164 1143 29397196
Coronary artery bypass 12.69 10.55 6 176182 4679 29393660
Therapeutic product effect decreased 12.61 10.55 246 175942 29205 29369134
Pulmonary tuberculosis 12.52 10.55 5 176183 4310 29394029
Hallucination 12.51 10.55 352 175836 44360 29353979
Cyanosis 12.47 10.55 112 176076 11155 29387184
Paranoia 12.41 10.55 101 176087 9776 29388563
Haemodynamic instability 12.41 10.55 18 176170 8055 29390284
Lumbosacral plexopathy 12.39 10.55 3 176185 0 29398339
Analgesic drug level decreased 12.39 10.55 3 176185 0 29398339
Chronic leukaemia 12.39 10.55 3 176185 0 29398339
Infective glossitis 12.39 10.55 3 176185 0 29398339
Hand amputation 12.39 10.55 3 176185 0 29398339
Fungal infection 12.35 10.55 41 176147 13644 29384695
Hospitalisation 12.35 10.55 196 175992 45792 29352547
Extrapyramidal disorder 12.34 10.55 29 176159 10802 29387537
Myofascial pain syndrome 12.31 10.55 12 176176 298 29398041
Tremor neonatal 12.27 10.55 13 176175 357 29397982
Rectal haemorrhage 12.27 10.55 139 176049 34410 29363929
Facet joint syndrome 12.26 10.55 11 176177 245 29398094
Hepatitis 12.25 10.55 73 176115 20710 29377629
Lung cancer metastatic 12.23 10.55 37 176151 2390 29395949
Status epilepticus 12.21 10.55 29 176159 10765 29387574
Coronary arterial stent insertion 12.18 10.55 4 176184 3893 29394446
Blood pH decreased 12.17 10.55 34 176154 2099 29396240
Loss of personal independence in daily activities 12.10 10.55 216 175972 25224 29373115
Red blood cell sedimentation rate increased 12.06 10.55 81 176107 7380 29390959
Blood creatine phosphokinase increased 12.02 10.55 170 176018 40474 29357865
Hepatic enzyme increased 12.00 10.55 136 176052 33663 29364676
General physical health deterioration 11.95 10.55 496 175692 102361 29295978
Lymphopenia 11.90 10.55 41 176147 13492 29384847
Mitral valve incompetence 11.88 10.55 40 176148 13253 29385086
Visual acuity reduced 11.82 10.55 47 176141 14829 29383510
Underdose 11.82 10.55 34 176154 11835 29386504
Nephrosclerosis 11.80 10.55 19 176169 795 29397544
Bradykinesia 11.77 10.55 3 176185 3444 29394895
Pulmonary granuloma 11.70 10.55 25 176163 1301 29397038
Intraocular pressure increased 11.70 10.55 7 176181 4782 29393557
Pseudomonas infection 11.62 10.55 30 176158 10822 29387517
Failure to thrive 11.58 10.55 82 176106 7602 29390737
Acidosis 11.54 10.55 98 176090 9607 29388732
Arteriosclerosis coronary artery 11.52 10.55 105 176083 10500 29387839
Pupillary light reflex tests abnormal 11.51 10.55 8 176180 121 29398218
Therapeutic response decreased 11.51 10.55 93 176095 24618 29373721
Medical device pain 11.47 10.55 6 176182 52 29398287
Face oedema 11.34 10.55 28 176160 10255 29388084
Nasal congestion 11.30 10.55 66 176122 18813 29379526
Photosensitivity reaction 11.28 10.55 94 176094 9164 29389175
Palpitations 11.26 10.55 132 176056 32472 29365867
Polyneuropathy 11.25 10.55 36 176152 12116 29386223
Drug ineffective for unapproved indication 11.23 10.55 45 176143 14169 29384170
Subdural haematoma 11.21 10.55 63 176125 18130 29380209
Pancreatic carcinoma 11.19 10.55 77 176111 7073 29391266
Arrhythmia 11.11 10.55 126 176062 31187 29367152
Mesothelioma 11.10 10.55 13 176175 400 29397939
Purpura 11.10 10.55 24 176164 9208 29389131
Blood glucose increased 11.08 10.55 267 175921 58717 29339622
Inflammatory marker increased 11.06 10.55 4 176184 3663 29394676
Back disorder 10.98 10.55 67 176121 5906 29392433
Metabolic acidosis 10.97 10.55 158 176030 37504 29360835
Pneumocystis jirovecii pneumonia 10.95 10.55 57 176131 16722 29381617
Synovitis 10.92 10.55 106 176082 10784 29387555
Salivary hypersecretion 10.92 10.55 17 176171 7392 29390947
Hepatitis B 10.89 10.55 10 176178 5487 29392852
Toothache 10.89 10.55 64 176124 5568 29392771
Product counterfeit 10.87 10.55 8 176180 133 29398206
Refusal of treatment by patient 10.85 10.55 56 176132 4638 29393701
PCO2 increased 10.84 10.55 15 176173 547 29397792
Spinal cord injury 10.75 10.55 12 176176 350 29397989
Blood alkaline phosphatase increased 10.75 10.55 233 175955 28173 29370166
Oropharyngeal pain 10.73 10.55 117 176071 29168 29369171
Injection site mass 10.71 10.55 10 176178 5445 29392894
Tumour necrosis 10.69 10.55 22 176166 1115 29397224
Spinal cord compression 10.67 10.55 46 176142 3536 29394803
Lymphoma 10.65 10.55 27 176161 9801 29388538
Hyponatraemia 10.65 10.55 314 175874 67319 29331020
Hypertension 10.63 10.55 577 175611 116037 29282302
Small for dates baby 10.63 10.55 4 176184 3575 29394764
Hypogonadism 10.58 10.55 26 176162 1485 29396854
Rash erythematous 10.58 10.55 80 176108 21482 29376857
Oesophageal motility disorder 10.58 10.55 6 176182 62 29398277
Partial seizures 10.57 10.55 5 176183 3898 29394441

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
Drug abuse 3785.29 9.70 4066 338911 128308 64027447
Completed suicide 2182.26 9.70 4113 338864 220301 63935454
Respiratory arrest 1883.02 9.70 1832 341145 51153 64104602
Toxicity to various agents 1639.55 9.70 4938 338039 358575 63797180
Drug abuser 1491.18 9.70 692 342285 5116 64150639
Drug dependence 1334.24 9.70 1231 341746 32081 64123674
Overdose 1146.50 9.70 2584 340393 156982 63998773
Accidental overdose 965.69 9.70 1036 341941 32521 64123234
Drug withdrawal syndrome 898.58 9.70 965 342012 30326 64125429
Cardio-respiratory arrest 821.43 9.70 1694 341283 96699 64059056
Cardiac arrest 716.43 9.70 2119 340858 151945 64003810
Substance abuse 645.14 9.70 473 342504 8819 64146936
Inadequate analgesia 606.16 9.70 333 342644 3645 64152110
Off label use 553.55 9.70 1636 341341 631170 63524585
Intentional product misuse 443.71 9.70 1102 341875 71193 64084562
Death 441.88 9.70 4206 338771 478499 63677256
Poisoning 431.90 9.70 557 342420 21322 64134433
Respiratory depression 367.77 9.70 534 342443 22909 64132846
Muscle injury 365.97 9.70 568 342409 25869 64129886
Irritable bowel syndrome 337.30 9.70 665 342312 36704 64119051
Folliculitis 328.67 9.70 581 342396 29496 64126259
Delirium 321.45 9.70 952 342025 68242 64087513
Sleep disorder due to general medical condition, insomnia type 315.30 9.70 529 342448 25741 64130014
Miosis 279.66 9.70 349 342628 12917 64142838
Drug screen positive 273.60 9.70 234 342743 5495 64150260
Accidental death 263.96 9.70 192 342785 3533 64152222
Confusional state 250.90 9.70 2301 340676 258843 63896912
Constipation 235.79 9.70 2051 340926 227286 63928469
Malignant neoplasm progression 232.80 9.70 1201 341776 111670 64044085
Product use in unapproved indication 225.00 9.70 370 342607 176248 63979507
Impaired healing 215.53 9.70 760 342217 59713 64096042
Drug ineffective 199.24 9.70 3209 339768 837038 63318717
Somnolence 195.26 9.70 1794 341183 201851 63953904
Stomatitis 193.51 9.70 1118 341859 108487 64047268
Unresponsive to stimuli 189.73 9.70 645 342332 49748 64106007
Mental status changes 178.45 9.70 721 342256 60441 64095314
Drug tolerance 169.94 9.70 185 342792 5900 64149855
Lower respiratory tract infection 169.56 9.70 969 342008 93645 64062110
Hyperaesthesia 168.66 9.70 236 342741 9778 64145977
Exposure via ingestion 165.57 9.70 165 342812 4737 64151018
Cough 160.25 9.70 946 342031 301202 63854553
Condition aggravated 158.78 9.70 1244 341733 371182 63784573
Plasma cell myeloma 156.44 9.70 570 342407 45505 64110250
Gun shot wound 148.28 9.70 84 342893 980 64154775
Toxic leukoencephalopathy 146.07 9.70 79 342898 836 64154919
Ill-defined disorder 145.38 9.70 540 342437 43512 64112243
Injection site pain 143.12 9.70 232 342745 111176 64044579
Duodenal ulcer perforation 129.29 9.70 442 342535 34183 64121572
Blister 128.88 9.70 804 342173 80163 64075592
Respiratory rate decreased 126.22 9.70 137 342840 4354 64151401
Exposure during pregnancy 126.07 9.70 136 342841 77539 64078216
Coma 125.99 9.70 848 342129 86767 64068988
Helicobacter infection 121.41 9.70 464 342513 37898 64117857
Cytomegalovirus infection 115.11 9.70 28 342949 37171 64118584
Injection site erythema 108.34 9.70 130 342847 70670 64085085
Drug resistance 107.49 9.70 27 342950 35075 64120680
Cardiac failure 107.45 9.70 353 342624 132020 64023735
Depressed level of consciousness 101.25 9.70 761 342216 80675 64075080
Drug reaction with eosinophilia and systemic symptoms 100.78 9.70 84 342893 54133 64101622
Narcotic bowel syndrome 100.29 9.70 41 342936 213 64155542
Injection site swelling 94.41 9.70 51 342926 41302 64114453
Drug interaction 92.72 9.70 1361 341616 360722 63795033
Product use issue 92.50 9.70 453 342524 151262 64004493
Sopor 92.42 9.70 22 342955 29639 64126116
Muscle spasticity 87.73 9.70 240 342737 16429 64139326
Injection site reaction 87.10 9.70 72 342905 46592 64109163
Gastrointestinal disorder 86.70 9.70 792 342185 88917 64066838
Lethargy 86.12 9.70 671 342306 71923 64083832
Device expulsion 85.98 9.70 7 342970 21129 64134626
Angioedema 83.90 9.70 124 342853 61697 64094058
Lactic acidosis 83.52 9.70 123 342854 61287 64094468
Toxicologic test abnormal 81.97 9.70 61 342916 1164 64154591
Asthma 81.43 9.70 248 342729 94977 64060778
Malaise 80.99 9.70 1552 341425 394695 63761060
Product dose omission issue 79.38 9.70 658 342319 194089 63961666
Medication error 78.14 9.70 494 342483 49472 64106283
Enthesopathy 78.02 9.70 164 342813 9474 64146281
Deafness neurosensory 74.67 9.70 127 342850 6247 64149508
Drug use disorder 74.08 9.70 123 342854 5931 64149824
Therapeutic product effect decreased 73.53 9.70 937 342040 114414 64041341
Atrial fibrillation 71.12 9.70 575 342402 170514 63985241
Back pain 70.71 9.70 1786 341191 248385 63907370
Night sweats 69.07 9.70 376 342601 35670 64120085
Epilepsy 68.66 9.70 47 342930 33484 64122271
Withdrawal syndrome 68.54 9.70 277 342700 23215 64132540
Tenosynovitis 67.97 9.70 176 342801 11657 64144098
Therapeutic product effect incomplete 67.17 9.70 302 342675 103180 64052575
Psoriasis 66.99 9.70 179 342798 71524 64084231
COVID-19 66.80 9.70 155 342822 64985 64090770
Sinusitis 66.41 9.70 1118 341859 144810 64010945
Deep vein thrombosis 65.18 9.70 850 342127 104332 64051423
Abortion spontaneous 65.14 9.70 26 342951 25117 64130638
Bradypnoea 64.72 9.70 106 342871 5053 64150702
Dizziness 63.91 9.70 1770 341207 428393 63727362
Palpitations 63.08 9.70 313 342664 104175 64051580
Paroxysmal sympathetic hyperactivity 62.81 9.70 16 342961 6 64155749
Pulmonary embolism 62.53 9.70 1110 341867 145246 64010509
Body temperature increased 61.41 9.70 369 342608 36297 64119458
Nasal necrosis 60.44 9.70 24 342953 114 64155641
Serotonin syndrome 59.34 9.70 385 342592 38897 64116858
Toxic epidermal necrolysis 59.27 9.70 66 342911 37100 64118655
Tongue disorder 58.73 9.70 169 342808 11911 64143844
Syncope 57.87 9.70 547 342430 157088 63998667
Product complaint 56.93 9.70 166 342811 11788 64143967
Cardiac failure congestive 56.51 9.70 434 342543 130146 64025609
Presbyacusis 56.29 9.70 69 342908 2506 64153249
Peripheral swelling 55.53 9.70 1481 341496 207672 63948083
Cancer pain 55.49 9.70 89 342888 4168 64151587
Delusional disorder, unspecified type 54.72 9.70 39 342938 694 64155061
Hypoglycaemia 54.42 9.70 269 342708 89623 64066132
Nasal congestion 54.18 9.70 151 342826 59507 64096248
Drug tolerance increased 53.31 9.70 36 342941 585 64155170
Compartment syndrome 53.15 9.70 87 342890 4145 64151610
Acute kidney injury 52.58 9.70 1907 341070 447333 63708422
Cardiogenic shock 52.36 9.70 57 342920 32370 64123385
Incorrect route of product administration 52.27 9.70 254 342723 23044 64132711
Injection site pruritus 52.18 9.70 75 342902 37751 64118004
Transplant rejection 52.10 9.70 14 342963 17387 64138368
Alanine aminotransferase abnormal 52.07 9.70 114 342863 6774 64148981
Hypertension 51.21 9.70 1021 341956 258240 63897515
Vomiting 51.10 9.70 3492 339485 547625 63608130
Cataract 50.95 9.70 124 342853 51138 64104617
Melaena 50.53 9.70 133 342844 53415 64102340
Pleural fibrosis 50.52 9.70 83 342894 3967 64151788
Accidental exposure to product by child 50.18 9.70 64 342913 2421 64153334
Cholecystitis chronic 50.16 9.70 135 342842 9152 64146603
Oropharyngeal pain 49.82 9.70 273 342704 88594 64067161
Productive cough 49.71 9.70 210 342767 72993 64082762
Vertigo 48.81 9.70 156 342821 58855 64096900
Sedation 48.47 9.70 382 342595 41080 64114675
Rheumatoid factor positive 48.46 9.70 69 342908 34869 64120886
C-reactive protein abnormal 48.44 9.70 292 342685 28755 64127000
Neutropenia 48.43 9.70 940 342037 238684 63917071
Blood magnesium increased 48.35 9.70 72 342905 3159 64152596
Myelosuppression 48 9.70 34 342943 23796 64131959
Influenza 47.54 9.70 351 342626 106180 64049575
Aspergillus infection 47.51 9.70 14 342963 16365 64139390
Circulatory collapse 47.40 9.70 66 342911 33666 64122089
Ear pain 47.35 9.70 261 342716 24875 64130880
Headache 47.16 9.70 2318 340659 527149 63628606
Alcohol use 46.57 9.70 86 342891 4516 64151239
Disease progression 46.24 9.70 1032 341945 140648 64015107
Bradycardia 46.09 9.70 404 342573 117815 64037940
Blood pressure increased 46.04 9.70 643 342334 171909 63983846
Rhinorrhoea 45.21 9.70 165 342812 59804 64095951
Red blood cell sedimentation rate 44.83 9.70 75 342902 3639 64152116
Anaphylactic reaction 44.78 9.70 200 342777 68464 64087291
Pericarditis 44.68 9.70 519 342458 61997 64093758
Seizure 44.49 9.70 622 342355 166270 63989485
Myalgia 44.14 9.70 586 342391 158031 63997724
Haematotoxicity 43.39 9.70 8 342969 12888 64142867
Anti-cyclic citrullinated peptide antibody positive 43.12 9.70 428 342549 49134 64106621
Cerebral haemorrhage 43.00 9.70 134 342843 50956 64104799
Pleural thickening 42.88 9.70 62 342915 2648 64153107
Eosinophilia 42.85 9.70 86 342891 37990 64117765
Foreign body reaction 42.61 9.70 18 342959 103 64155652
Maternal exposure during pregnancy 42.27 9.70 317 342660 95567 64060188
Dependence 41.17 9.70 54 342923 2101 64153654
Poisoning deliberate 41.12 9.70 161 342816 13297 64142458
Treatment failure 40.90 9.70 410 342567 116406 64039349
Hypercalcaemia 40.40 9.70 296 342681 31120 64124635
Spinal cord ischaemia 40.08 9.70 18 342959 122 64155633
Oesophageal motility disorder 39.70 9.70 27 342950 444 64155311
Acute lung injury 39.65 9.70 60 342917 2671 64153084
Angina pectoris 39.54 9.70 116 342861 44965 64110790
Epistaxis 39.30 9.70 333 342644 97798 64057957
Apparent death 39.14 9.70 59 342918 2617 64153138
Osteosclerosis 38.92 9.70 68 342909 3418 64152337
Injection site bruising 38.55 9.70 85 342892 36288 64119467
Renal impairment 38.22 9.70 497 342480 134520 64021235
Proteinuria 38.21 9.70 55 342922 27668 64128087
Nausea 38.15 9.70 4752 338225 781048 63374707
Synovitis 37.95 9.70 739 342238 98351 64057404
Brain injury 37.89 9.70 128 342849 9837 64145918
Haematochezia 37.70 9.70 203 342774 66170 64089585
Terminal state 37.59 9.70 77 342900 4367 64151388
Epstein-Barr virus infection 37.48 9.70 10 342967 12478 64143277
Depression 37.29 9.70 1256 341721 182035 63973720
Apnoea 37.12 9.70 131 342846 10291 64145464
Road traffic accident 36.90 9.70 285 342692 30460 64125295
Stress 36.72 9.70 181 342796 60353 64095402
Aplastic anaemia 36.71 9.70 14 342963 13906 64141849
Post transplant lymphoproliferative disorder 36.59 9.70 4 342973 9540 64146215
Chest discomfort 36.04 9.70 419 342558 115687 64040068
Pathogen resistance 35.88 9.70 11 342966 12532 64143223
Agitation 35.54 9.70 664 342313 87703 64068052
Drug detoxification 35.25 9.70 20 342957 234 64155521
Leukopenia 35.17 9.70 356 342621 100886 64054869
Neuroleptic malignant syndrome 35.03 9.70 49 342928 24947 64130808
Emotional distress 34.71 9.70 318 342659 35720 64120035
Sinus tachycardia 34.62 9.70 291 342686 31897 64123858
Infection 33.92 9.70 1252 341725 183628 63972127
Immune reconstitution inflammatory syndrome 33.80 9.70 12 342965 12458 64143297
Non-small cell lung cancer 33.69 9.70 78 342899 4812 64150943
Dehydration 33.28 9.70 1440 341537 215323 63940432
Pupillary reflex impaired 33.09 9.70 59 342918 3014 64152741
Velopharyngeal incompetence 33.04 9.70 9 342968 7 64155748
Hepatitis 32.68 9.70 128 342849 45454 64110301
Hyperhidrosis 32.67 9.70 883 342094 124037 64031718
Insomnia 32.58 9.70 1324 341653 196512 63959243
Glossodynia 32.52 9.70 504 342473 64192 64091563
Anxiety 32.41 9.70 1352 341625 201297 63954458
Bronchitis 32.00 9.70 397 342580 108346 64047409
Self-medication 31.79 9.70 69 342908 4076 64151679
No adverse event 31.72 9.70 65 342912 28496 64127259
Contusion 31.66 9.70 812 342165 113153 64042602
Agranulocytosis 31.65 9.70 101 342876 38128 64117627
Salpingo-oophorectomy unilateral 31.64 9.70 24 342953 472 64155283
Bronchiectasis 31.46 9.70 18 342959 14122 64141633
Arthropathy 31.34 9.70 854 342123 120113 64035642
Throat irritation 31.05 9.70 81 342896 32630 64123125
Inappropriate schedule of product administration 31.03 9.70 327 342650 91959 64063796
Blood pressure fluctuation 30.94 9.70 156 342821 51715 64104040
Premature delivery 30.76 9.70 32 342945 18557 64137198
Allodynia 30.70 9.70 36 342941 1247 64154508
Failure to thrive 30.61 9.70 123 342854 10281 64145474
Acute myocardial infarction 30.48 9.70 231 342746 69487 64086268
Colitis ulcerative 30.46 9.70 47 342930 22981 64132774
Victim of homicide 30.27 9.70 16 342961 161 64155594
Septic shock 30.25 9.70 387 342590 105050 64050705
Underdose 30.23 9.70 57 342920 25772 64129983
Injection site warmth 30.15 9.70 17 342960 13445 64142310
Injury 30.01 9.70 441 342536 55551 64100204
Live birth 30.00 9.70 11 342966 11193 64144562
Swollen tongue 29.89 9.70 91 342886 34863 64120892
Substance dependence 29.70 9.70 23 342954 467 64155288
Myoclonus 29.68 9.70 232 342745 24886 64130869
Anaphylactic shock 29.64 9.70 74 342903 30254 64125501
Anoxia 29.61 9.70 20 342957 325 64155430
Viral infection 29.56 9.70 96 342881 36044 64119711
Hepatotoxicity 29.43 9.70 111 342866 39851 64115904
Hypoxia 29.35 9.70 644 342333 87505 64068250
Mobility decreased 29.34 9.70 303 342674 85537 64070218
Soft tissue disorder 29.19 9.70 58 342919 3218 64152537
Drug diversion 29.08 9.70 33 342944 1103 64154652
Hyponatraemia 29.01 9.70 585 342392 147754 64008001
Glomerular filtration rate decreased 28.82 9.70 37 342940 19535 64136220
Multiple organ dysfunction syndrome 28.81 9.70 373 342604 101040 64054715
Breakthrough pain 28.81 9.70 34 342943 1186 64154569
Lip swelling 28.79 9.70 81 342896 31826 64123929
Accident 28.78 9.70 91 342886 6755 64149000
Intentional overdose 28.66 9.70 653 342324 89291 64066464
Female genital tract fistula 28.58 9.70 51 342926 2607 64153148
Granulocytopenia 28.38 9.70 10 342967 10430 64145325
Sickle cell anaemia with crisis 28.28 9.70 77 342900 5255 64150500
Injection site mass 28.28 9.70 30 342947 17240 64138515
Diabetes mellitus 28.24 9.70 222 342755 66252 64089503
Drug screen negative 28.23 9.70 18 342959 264 64155491
Pemphigoid 28.23 9.70 17 342960 12969 64142786
Drug ineffective for unapproved indication 28.12 9.70 79 342898 31054 64124701
Myelodysplastic syndrome 27.97 9.70 66 342911 27513 64128242
Status epilepticus 27.90 9.70 45 342932 21618 64134137
Musculoskeletal stiffness 27.79 9.70 474 342503 122732 64033023
Acute graft versus host disease 27.79 9.70 7 342970 9077 64146678
Extrapyramidal disorder 27.73 9.70 38 342939 19514 64136241
Blood parathyroid hormone decreased 27.46 9.70 94 342883 7272 64148483
Drug-induced liver injury 27.45 9.70 145 342832 47498 64108257
Device issue 27.38 9.70 49 342928 22599 64133156
Haemophagocytic lymphohistiocytosis 27.29 9.70 32 342945 17577 64138178
Cerebrovascular accident 27.07 9.70 542 342435 137041 64018714
Parkinsonism 27.04 9.70 22 342955 14351 64141404
Post laminectomy syndrome 26.95 9.70 18 342959 287 64155468
Small intestinal obstruction 26.36 9.70 215 342762 23358 64132397
Respiratory tract infection 26.21 9.70 106 342871 37301 64118454
Intraocular pressure increased 26.17 9.70 6 342971 8296 64147459
Product formulation issue 26.10 9.70 27 342950 811 64154944
Bone cyst 26.03 9.70 44 342933 2153 64153602
Creatinine renal clearance decreased 25.99 9.70 23 342954 14398 64141357
Atrioventricular block complete 25.98 9.70 23 342954 14395 64141360
Ileus 25.97 9.70 210 342767 22756 64132999
Discomfort 25.71 9.70 587 342390 80291 64075464
Pulmonary arterial hypertension 25.49 9.70 61 342916 25306 64130449
Tooth loss 25.32 9.70 82 342895 6165 64149590
Arrhythmia 25.29 9.70 171 342806 52773 64102982
Aspiration 25.20 9.70 165 342812 16720 64139035
Cardiac failure acute 25.01 9.70 30 342947 16314 64139441
Granuloma skin 24.86 9.70 80 342897 5994 64149761
Haemorrhage 24.76 9.70 286 342691 79065 64076690
Type 2 diabetes mellitus 24.73 9.70 95 342882 33925 64121830
Opiates positive 24.55 9.70 27 342950 871 64154884
Ear infection 24.55 9.70 55 342922 23349 64132406
Wheezing 24.53 9.70 292 342685 80287 64075468
COVID-19 pneumonia 24.51 9.70 31 342946 16473 64139282
Hypertensive crisis 24.37 9.70 37 342940 18211 64137544
Spinal fracture 24.33 9.70 151 342826 15023 64140732
Progressive multifocal leukoencephalopathy 24.31 9.70 37 342940 18195 64137560
Caesarean section 24.17 9.70 15 342962 11259 64144496
Accidental poisoning 24.11 9.70 34 342943 1419 64154336
BK virus infection 24.09 9.70 5 342972 7407 64148348
Jaundice 24.02 9.70 155 342822 48357 64107398
Device difficult to use 24.00 9.70 11 342966 9787 64145968
Faecaloma 23.97 9.70 109 342868 9619 64146136
Mucormycosis 23.76 9.70 5 342972 7336 64148419
Dyspnoea exertional 23.68 9.70 264 342713 73466 64082289
Piloerection 23.67 9.70 19 342958 407 64155348
Upper respiratory tract infection 23.62 9.70 260 342717 72525 64083230
Flushing 23.56 9.70 286 342691 78362 64077393
Spinal operation 23.51 9.70 79 342898 6054 64149701
Neutrophil count increased 23.39 9.70 63 342914 25111 64130644
Pulmonary tuberculosis 23.31 9.70 5 342972 7239 64148516
Foreign body embolism 23.14 9.70 7 342970 11 64155744
Inflammatory marker increased 23.13 9.70 8 342969 8443 64147312
Cardiotoxicity 22.97 9.70 13 342964 10261 64145494
Pneumocystis jirovecii pneumonia 22.88 9.70 73 342904 27561 64128194
Respiratory disorder 22.85 9.70 293 342684 35818 64119937
Rash erythematous 22.77 9.70 158 342819 48475 64107280
Erythema 22.75 9.70 790 342187 186280 63969475
Fluid retention 22.65 9.70 205 342772 59401 64096354
Gastrointestinal haemorrhage 22.63 9.70 533 342444 131779 64023976
Myopathy 22.52 9.70 37 342940 17643 64138112
Paradoxical drug reaction 22.39 9.70 3 342974 6117 64149638
Cardiac failure chronic 22.38 9.70 10 342967 9031 64146724
Panniculitis 22.27 9.70 100 342877 8779 64146976
Eczema 22.25 9.70 82 342895 29638 64126117
Neoplasm progression 22.09 9.70 323 342654 40641 64115114
Pulmonary granuloma 22.02 9.70 37 342940 1802 64153953
Swelling face 21.83 9.70 205 342772 58961 64096794
Malignant melanoma 21.81 9.70 22 342955 12942 64142813
Decreased appetite 21.69 9.70 1757 341220 279532 63876223
Injection site haemorrhage 21.63 9.70 62 342915 24216 64131539
Forced expiratory volume decreased 21.58 9.70 5 342972 6862 64148893
Hallucination 21.51 9.70 523 342454 72265 64083490
Generalised tonic-clonic seizure 21.49 9.70 124 342853 39733 64116022
Cyst 21.40 9.70 123 342854 11904 64143851
Troponin T increased 21.37 9.70 42 342935 2311 64153444
Diabetic ketoacidosis 21.27 9.70 84 342893 29761 64125994
Premature labour 21.23 9.70 7 342970 7613 64148142
Cervix neoplasm 21.22 9.70 13 342964 177 64155578
Lumbosacral plexopathy 21.21 9.70 5 342972 0 64155755
Therapeutic response shortened 21.16 9.70 14 342963 10156 64145599
Metastatic renal cell carcinoma 20.93 9.70 40 342937 2156 64153599
Bone marrow failure 20.90 9.70 159 342818 47793 64107962
Chronic graft versus host disease 20.89 9.70 4 342973 6272 64149483
Orthostatic hypotension 20.84 9.70 154 342823 46584 64109171
Joint stiffness 20.77 9.70 87 342890 30317 64125438
Eye pruritus 20.72 9.70 22 342955 12637 64143118
Emphysema 20.70 9.70 137 342840 13932 64141823
Pemphigus 20.69 9.70 445 342532 60256 64095499
Nephrosclerosis 20.69 9.70 33 342944 1538 64154217
Maternal exposure timing unspecified 20.69 9.70 45 342932 2662 64153093
Tumour pain 20.67 9.70 37 342940 1896 64153859
Sleep disorder due to a general medical condition 20.55 9.70 9 342968 8225 64147530
Hypophagia 20.51 9.70 310 342667 39277 64116478
Hypothalamic pituitary adrenal axis suppression 20.48 9.70 15 342962 279 64155476
Secretion discharge 20.48 9.70 20 342957 11944 64143811
Myocardial infarction 20.45 9.70 699 342278 165122 63990633
Stevens-Johnson syndrome 20.43 9.70 103 342874 34146 64121609
Thermophobia 20.29 9.70 9 342968 59 64155696
Joint swelling 20.26 9.70 1367 341610 214015 63941740
Anaemia 20.20 9.70 1736 341241 376944 63778811
Leukoencephalopathy 20.20 9.70 82 342895 6885 64148870
Tendonitis 20.06 9.70 180 342797 20102 64135653
Sinusitis fungal 19.99 9.70 34 342943 1672 64154083
Injection site urticaria 19.95 9.70 18 342959 11163 64144592
Blood pH decreased 19.89 9.70 60 342917 4342 64151413
Tuberculosis 19.87 9.70 24 342953 13014 64142741
Cardiomegaly 19.86 9.70 203 342774 23481 64132274
Swelling 19.83 9.70 1042 341935 159176 63996579
Dyspnoea 19.72 9.70 3442 339535 715232 63440523
Impaired reasoning 19.59 9.70 10 342967 93 64155662
Bronchospasm 19.59 9.70 55 342922 21627 64134128
Acute hepatic failure 19.57 9.70 72 342905 26040 64129715
Pupil fixed 19.53 9.70 49 342928 3183 64152572
Eosinophil count increased 19.44 9.70 28 342949 14084 64141671
Lung cancer metastatic 19.39 9.70 48 342929 3092 64152663
Immunodeficiency 19.39 9.70 35 342942 16089 64139666
Compression fracture 19.38 9.70 71 342906 5681 64150074
Glaucoma 19.20 9.70 36 342941 16312 64139443
Wrong technique in product usage process 19.19 9.70 237 342740 64737 64091018
Hand deformity 19.15 9.70 453 342524 62318 64093437
Aspartate aminotransferase increased 19.09 9.70 799 342178 118989 64036766
Concomitant disease aggravated 18.95 9.70 20 342957 11522 64144233
Faecalith 18.93 9.70 6 342971 12 64155743
Cerebral infarction 18.90 9.70 134 342843 40910 64114845
Epigastric discomfort 18.83 9.70 79 342898 6732 64149023
Pneumonia aspiration 18.78 9.70 430 342547 58841 64096914
Coeliac disease 18.66 9.70 8 342969 7404 64148351
Renal cell carcinoma 18.63 9.70 73 342904 6031 64149724
Aplasia pure red cell 18.59 9.70 7 342970 7007 64148748
Haematuria 18.45 9.70 219 342758 60252 64095503
Wound 18.43 9.70 535 342442 75942 64079813
Congenital central hypoventilation syndrome 18.39 9.70 7 342970 29 64155726
Gallbladder disorder 18.33 9.70 154 342823 16876 64138879
Device dislocation 18.21 9.70 55 342922 21123 64134632
Arteriosclerosis coronary artery 18.11 9.70 143 342834 15386 64140369
Brain death 18.09 9.70 62 342915 4799 64150956
Hypogammaglobulinaemia 17.88 9.70 17 342960 10282 64145473
Environmental exposure 17.87 9.70 15 342962 343 64155412
Pain 17.86 9.70 3272 339705 550239 63605516
Decreased gait velocity 17.76 9.70 11 342966 153 64155602
Purpura 17.71 9.70 41 342936 17205 64138550
Injection site induration 17.65 9.70 13 342964 8919 64146836
Smear cervix abnormal 17.62 9.70 39 342938 2335 64153420
Chronic kidney disease 17.58 9.70 210 342767 57709 64098046
Lymphoproliferative disorder 17.53 9.70 3 342974 5100 64150655
Electrocardiogram QT prolonged 17.47 9.70 307 342670 79141 64076614
Ulcer 17.39 9.70 193 342784 22797 64132958
Acidosis 17.12 9.70 157 342820 17638 64138117
Lupus-like syndrome 17.11 9.70 13 342964 8778 64146977
Euphoric mood 17.11 9.70 75 342902 6516 64149239
Respiratory acidosis 17.03 9.70 100 342877 9755 64146000
Bone erosion 16.99 9.70 22 342955 11573 64144182
Rectal haemorrhage 16.95 9.70 229 342748 61588 64094167
Mouth ulceration 16.92 9.70 102 342875 32342 64123413
Nephropathy toxic 16.91 9.70 43 342934 17471 64138284
Blood pressure decreased 16.82 9.70 340 342637 85859 64069896
Aplasia 16.73 9.70 8 342969 6945 64148810
Breast cancer metastatic 16.69 9.70 79 342898 7090 64148665
Cytomegalovirus chorioretinitis 16.63 9.70 3 342974 4909 64150846
Paranoia 16.62 9.70 146 342831 16206 64139549
Metastases to bone 16.59 9.70 174 342803 20261 64135494
Snake bite 16.54 9.70 6 342971 21 64155734
Product counterfeit 16.53 9.70 12 342965 220 64155535
Dermatitis bullous 16.52 9.70 24 342953 12030 64143725
Hyperthyroidism 16.51 9.70 46 342931 18133 64137622
Feeling hot 16.51 9.70 159 342818 45504 64110251
Adenovirus infection 16.48 9.70 9 342968 7246 64148509
Device malfunction 16.48 9.70 44 342933 17589 64138166
Pseudomonas infection 16.43 9.70 45 342932 17838 64137917
Gait disturbance 16.39 9.70 748 342229 171407 63984348
Dyspepsia 16.21 9.70 315 342662 79997 64075758
Sphincter of Oddi dysfunction 16.20 9.70 15 342962 392 64155363
Thrombosis 16.15 9.70 491 342486 70151 64085604
Hypoxic-ischaemic encephalopathy 16.06 9.70 78 342899 7074 64148681
Prescribed underdose 16.06 9.70 46 342931 17969 64137786
Bone pain 15.97 9.70 348 342629 47224 64108531
Atelectasis 15.91 9.70 218 342759 27048 64128707
Disorientation 15.86 9.70 399 342578 55429 64100326
Ischaemic stroke 15.83 9.70 90 342887 28945 64126810
Transaminases increased 15.82 9.70 156 342821 44438 64111317
Gestational diabetes 15.81 9.70 5 342972 5585 64150170
Encephalopathy 15.72 9.70 417 342560 58402 64097353
Formication 15.72 9.70 55 342922 4302 64151453
Haemodynamic instability 15.67 9.70 35 342942 14877 64140878
Hypertriglyceridaemia 15.67 9.70 22 342955 11183 64144572
Neutrophilia 15.66 9.70 8 342969 6686 64149069
Arthrofibrosis 15.60 9.70 9 342968 109 64155646
Septic pulmonary embolism 15.55 9.70 6 342971 26 64155729
Nervousness 15.52 9.70 232 342745 29324 64126431
Pupillary light reflex tests abnormal 15.50 9.70 13 342964 297 64155458
Swollen joint count increased 15.45 9.70 11 342966 7678 64148077
Learning disability 15.42 9.70 11 342966 196 64155559
Human herpesvirus 6 infection 15.42 9.70 3 342974 4651 64151104
Visual acuity reduced 15.41 9.70 83 342894 27058 64128697
Cytomegalovirus viraemia 15.40 9.70 21 342956 10807 64144948
Multiple sclerosis relapse 15.40 9.70 142 342835 40993 64114762
Cardiovascular disorder 15.32 9.70 39 342938 15842 64139913
Pathological fracture 15.32 9.70 91 342886 8914 64146841
Artery dissection 15.28 9.70 11 342966 199 64155556
Blood potassium increased 15.27 9.70 208 342769 25772 64129983
Upper gastrointestinal haemorrhage 15.25 9.70 117 342860 35103 64120652
Ventricular tachycardia 15.23 9.70 113 342864 34152 64121603
Sarcopenia 15.22 9.70 14 342963 363 64155392
Acne 15.18 9.70 67 342910 23014 64132741
Pancreatitis acute 15.16 9.70 150 342827 42705 64113050
Spleen congestion 15.15 9.70 15 342962 427 64155328
Complications of transplanted kidney 15.13 9.70 5 342972 5430 64150325
Complication of device insertion 15.07 9.70 4 342973 5008 64150747
Red blood cell sedimentation rate abnormal 15.00 9.70 41 342936 16265 64139490
Torsade de pointes 14.99 9.70 45 342932 17318 64138437
Presyncope 14.99 9.70 117 342860 34972 64120783
C-reactive protein increased 14.95 9.70 387 342590 94522 64061233
Glycosylated haemoglobin increased 14.95 9.70 40 342937 15979 64139776
Injection site discolouration 14.94 9.70 9 342968 6866 64148889
Hysterectomy 14.86 9.70 60 342917 5025 64150730
Gonadotrophin deficiency 14.86 9.70 6 342971 30 64155725
Cerebral haematoma 14.80 9.70 10 342967 7175 64148580
Weight increased 14.76 9.70 1322 341655 212026 63943729
Oral herpes 14.76 9.70 64 342913 22088 64133667
Hyperkalaemia 14.73 9.70 417 342560 100712 64055043
Central nervous system stimulation 14.70 9.70 6 342971 31 64155724
Gastroenteritis 14.67 9.70 95 342882 29616 64126139
Refusal of treatment by patient 14.65 9.70 85 342892 8254 64147501
Hypoventilation 14.58 9.70 67 342910 5939 64149816
Schizophrenia 14.57 9.70 23 342954 11145 64144610
Loss of consciousness 14.54 9.70 945 342032 147420 64008335
Atrioventricular block 14.52 9.70 26 342951 11989 64143766
Impaired driving ability 14.48 9.70 56 342921 4598 64151157
Product residue present 14.47 9.70 44 342933 3198 64152557
Urinary tract infection 14.46 9.70 1048 341929 230548 63925207
Therapeutic response decreased 14.43 9.70 193 342784 51995 64103760
Abortion induced 14.40 9.70 8 342969 6380 64149375
Hypomania 14.40 9.70 6 342971 5648 64150107
Periorbital oedema 14.38 9.70 11 342966 7403 64148352
Subarachnoid haemorrhage 14.38 9.70 50 342927 18388 64137367
Vestibular ischaemia 14.36 9.70 5 342972 15 64155740
Brain oedema 14.34 9.70 180 342797 21895 64133860
Liver function test increased 14.31 9.70 101 342876 30869 64124886
Sneezing 14.29 9.70 38 342939 15213 64140542
Snoring 14.29 9.70 56 342921 4626 64151129
Tumour haemorrhage 14.29 9.70 46 342931 3447 64152308
Needle issue 14.20 9.70 17 342960 9255 64146500
Obsessive-compulsive disorder 14.20 9.70 57 342920 4761 64150994
Osteoporosis 14.18 9.70 149 342828 41931 64113824
Injection site rash 14.17 9.70 40 342937 15702 64140053
Balance disorder 14.09 9.70 339 342638 83587 64072168
Thrombocytopenia 14.09 9.70 1012 341965 222789 63932966
Bronchopulmonary aspergillosis 14.06 9.70 53 342924 19032 64136723
Blood creatine phosphokinase MB increased 14.05 9.70 38 342939 2583 64153172
Heart rate decreased 14.04 9.70 207 342770 54860 64100895
Metastases to spine 14.03 9.70 47 342930 3596 64152159
Eyelid ptosis 14.03 9.70 18 342959 9507 64146248
Cystitis 14.02 9.70 152 342825 42523 64113232
Partial seizures 13.98 9.70 11 342966 7296 64148459
Salivary hypersecretion 13.94 9.70 27 342950 12086 64143669
Gamma-glutamyltransferase increased 13.93 9.70 178 342799 48332 64107423
Catatonia 13.92 9.70 12 342965 7608 64148147
Blood alkaline phosphatase increased 13.91 9.70 395 342582 55884 64099871
Drug specific antibody present 13.90 9.70 5 342972 5149 64150606
Systemic lupus erythematosus 13.83 9.70 524 342453 77088 64078667
Dermatitis exfoliative 13.81 9.70 21 342956 10331 64145424
Liver disorder 13.79 9.70 200 342777 53151 64102604
Aptyalism 13.71 9.70 18 342959 701 64155054
Intestinal sepsis 13.71 9.70 17 342960 625 64155130
Disturbance in attention 13.64 9.70 300 342677 40774 64114981
Rash papular 13.62 9.70 46 342931 17067 64138688
Postmortem blood drug level abnormal 13.60 9.70 17 342960 630 64155125
Back injury 13.59 9.70 79 342898 7678 64148077
Femur fracture 13.58 9.70 116 342861 34019 64121736
Stress cardiomyopathy 13.53 9.70 90 342887 9167 64146588
Coronary artery bypass 13.52 9.70 7 342970 5808 64149947
Therapeutic product effect increased 13.51 9.70 25 342952 1315 64154440
Rales 13.49 9.70 39 342938 15190 64140565
Therapy partial responder 13.47 9.70 21 342956 10227 64145528
Pulmonary thrombosis 13.46 9.70 99 342878 10419 64145336
Heart rate irregular 13.36 9.70 88 342889 27325 64128430
Analgesic drug level decreased 13.34 9.70 4 342973 6 64155749
Injection site extravasation 13.29 9.70 14 342963 8072 64147683
Uveitis 13.22 9.70 30 342947 12678 64143077
Myasthenia gravis 13.21 9.70 7 342970 5731 64150024
Subdural haematoma 13.20 9.70 91 342886 27963 64127792
Hepatitis B 13.20 9.70 13 342964 7732 64148023
Infusion site pain 13.02 9.70 22 342955 10375 64145380
Rash maculo-papular 12.97 9.70 174 342803 46852 64108903
Mandibular mass 12.96 9.70 10 342967 202 64155553
Hemiparesis 12.95 9.70 99 342878 29728 64126027
Metabolic encephalopathy 12.95 9.70 80 342897 7945 64147810
Lung transplant 12.89 9.70 3 342974 4105 64151650
Libido decreased 12.85 9.70 55 342922 4729 64151026
Ocular hyperaemia 12.81 9.70 69 342908 22495 64133260
Pulmonary congestion 12.76 9.70 188 342789 23692 64132063
Central cord syndrome 12.73 9.70 3 342974 0 64155755
Hormone replacement therapy 12.73 9.70 3 342974 0 64155755
Hypogonadism 12.63 9.70 21 342956 1014 64154741
Nodule 12.48 9.70 51 342926 17896 64137859
Hypotension 12.46 9.70 1806 341171 379168 63776587
Food allergy 12.45 9.70 14 342963 7837 64147918
Acute generalised exanthematous pustulosis 12.45 9.70 36 342941 14022 64141733
Lip oedema 12.44 9.70 6 342971 5183 64150572
Thrombotic microangiopathy 12.43 9.70 46 342931 16609 64139146
Bradykinesia 12.39 9.70 10 342967 6550 64149205
Drug level increased 12.39 9.70 119 342858 34077 64121678
Renal failure 12.36 9.70 816 342161 180872 63974883
Full blood count abnormal 12.35 9.70 100 342877 29657 64126098
Faeces discoloured 12.34 9.70 83 342894 25646 64130109
Exposure via breast milk 12.32 9.70 18 342959 776 64154979
Hallucination, synaesthetic 12.32 9.70 6 342971 50 64155705
Hallucination, tactile 12.31 9.70 14 342963 469 64155286
Signet-ring cell carcinoma 12.30 9.70 4 342973 9 64155746
Acute graft versus host disease in skin 12.27 9.70 11 342966 6844 64148911
Rheumatic fever 12.26 9.70 19 342958 9275 64146480
Tachyphylaxis 12.25 9.70 11 342966 276 64155479
Hepatocellular injury 12.25 9.70 168 342809 45067 64110688
Muscular weakness 12.17 9.70 553 342424 126785 64028970
Laryngeal pain 12.15 9.70 61 342916 5607 64150148
Acute coronary syndrome 12.14 9.70 57 342920 19253 64136502
Exposure via inhalation 12.12 9.70 7 342970 85 64155670
Irritability 12.08 9.70 268 342709 36478 64119277
Judgement impaired 12.07 9.70 21 342956 1052 64154703
Device use error 12.05 9.70 10 342967 6461 64149294
Impaired quality of life 12.05 9.70 10 342967 6461 64149294
Kidney transplant rejection 12.02 9.70 20 342957 9491 64146264
Eyelid oedema 11.97 9.70 30 342947 12249 64143506
Ventricular fibrillation 11.93 9.70 76 342901 23784 64131971
Autoimmune haemolytic anaemia 11.91 9.70 12 342965 7064 64148691
Coronary artery disease 11.90 9.70 238 342739 60195 64095560
Paraesthesia 11.90 9.70 589 342388 133933 64021822
Euglycaemic diabetic ketoacidosis 11.88 9.70 7 342970 5403 64150352
Product storage error 11.87 9.70 34 342943 13284 64142471
Shock 11.86 9.70 138 342839 38102 64117653
Electrocardiogram QRS complex prolonged 11.83 9.70 87 342890 9157 64146598
Venoocclusive liver disease 11.81 9.70 22 342955 9993 64145762
Dental caries 11.80 9.70 98 342879 10702 64145053
Endodontic procedure 11.78 9.70 33 342944 2290 64153465
Gingival bleeding 11.77 9.70 40 342937 14814 64140941
Polyneuropathy 11.77 9.70 60 342917 19834 64135921
Diabetes mellitus inadequate control 11.67 9.70 66 342911 21255 64134500
Sputum discoloured 11.64 9.70 52 342925 17804 64137951
Paranoid personality disorder 11.64 9.70 5 342972 30 64155725
Coronary arterial stent insertion 11.62 9.70 8 342969 5684 64150071
Facet joint syndrome 11.59 9.70 29 342948 1880 64153875
Device breakage 11.45 9.70 18 342959 8737 64147018
Tubulointerstitial nephritis 11.44 9.70 107 342870 30802 64124953
Spinal cord compression 11.27 9.70 60 342917 5643 64150112
Non-small cell lung cancer metastatic 11.25 9.70 18 342959 841 64154914
Renal cancer metastatic 11.25 9.70 16 342961 673 64155082
Oesophageal achalasia 11.23 9.70 16 342961 674 64155081
Squamous cell carcinoma 11.23 9.70 37 342940 13832 64141923
Hepatitis B reactivation 11.20 9.70 6 342971 4883 64150872
Sinus disorder 11.17 9.70 49 342928 16859 64138896
Grip strength decreased 11.15 9.70 29 342948 11695 64144060
Ketoacidosis 11.15 9.70 12 342965 6851 64148904
Cognitive disorder 11.13 9.70 216 342761 54871 64100884
Hemiplegia 11.09 9.70 33 342944 12735 64143020
Pulmonary infarction 11.05 9.70 40 342937 3182 64152573
Central nervous system injury 10.96 9.70 8 342969 148 64155607
Blood pressure diastolic abnormal 10.94 9.70 30 342947 11887 64143868
Liver injury 10.91 9.70 104 342873 29828 64125927
Gastric haemorrhage 10.89 9.70 36 342941 13445 64142310
Metastatic gastric cancer 10.89 9.70 11 342966 321 64155434
Polyarthritis 10.88 9.70 22 342955 9693 64146062
Rheumatoid nodule 10.88 9.70 109 342868 12542 64143213
Retinal haemorrhage 10.88 9.70 14 342963 7384 64148371
Pallor 10.87 9.70 143 342834 38638 64117117
Fear of injection 10.87 9.70 61 342916 5851 64149904
Cutaneous vasculitis 10.87 9.70 11 342966 6462 64149293
Application site burn 10.87 9.70 17 342960 779 64154976
Hyperprolactinaemia 10.87 9.70 4 342973 4061 64151694
Hypersomnia 10.84 9.70 156 342821 19561 64136194
Drug level below therapeutic 10.83 9.70 14 342963 7370 64148385
Pulmonary fibrosis 10.81 9.70 104 342873 29774 64125981
Atrioventricular block second degree 10.80 9.70 11 342966 6443 64149312
Plasmacytoma 10.79 9.70 45 342932 3825 64151930
Vitamin B12 deficiency 10.77 9.70 8 342969 5464 64150291
Cholangitis 10.75 9.70 96 342881 10706 64145049
Mental disorder 10.73 9.70 199 342778 26246 64129509
Product monitoring error 10.70 9.70 8 342969 5446 64150309
Non-obstructive cardiomyopathy 10.66 9.70 3 342974 3 64155752
Osteopenia 10.65 9.70 128 342849 15412 64140343
Second primary malignancy 10.63 9.70 32 342945 12305 64143450
Sensitivity to weather change 10.62 9.70 12 342965 6702 64149053
Metastases to meninges 10.56 9.70 36 342941 2779 64152976
Hypertensive heart disease 10.42 9.70 44 342933 3760 64151995
Tumour necrosis 10.42 9.70 26 342951 1683 64154072
Seasonal allergy 10.41 9.70 30 342947 11696 64144059
Face oedema 10.37 9.70 83 342894 24678 64131077
Selective eating disorder 10.36 9.70 9 342968 216 64155539
Protein urine present 10.27 9.70 20 342957 8936 64146819
Lumbar vertebral fracture 10.27 9.70 57 342920 5445 64150310
Diarrhoea 10.27 9.70 3567 339410 719137 63436618
Victim of crime 10.25 9.70 12 342965 415 64155340
Lymphatic obstruction 10.25 9.70 4 342973 18 64155737
Intestinal obstruction 10.20 9.70 259 342718 36027 64119728
Yawning 10.20 9.70 21 342956 1195 64154560
Mucosal inflammation 10.18 9.70 254 342723 62330 64093425
Blood test abnormal 10.16 9.70 35 342942 12908 64142847
Conjunctival hyperaemia 10.15 9.70 4 342973 3895 64151860
Inappropriate antidiuretic hormone secretion 10.15 9.70 73 342904 22216 64133539
Skin ulcer 10.15 9.70 306 342671 43668 64112087
Arteriosclerosis 10.12 9.70 129 342848 15748 64140007
Left ventricular dysfunction 10.10 9.70 51 342926 16903 64138852
Oedema 10.10 9.70 393 342584 91542 64064213
Cardiac disorder 10.06 9.70 223 342754 55593 64100162
Hepatic cancer 10.05 9.70 71 342906 7377 64148378
Hypoaesthesia oral 10.01 9.70 30 342947 11550 64144205
Failure to anastomose 9.99 9.70 9 342968 227 64155528
Sinus node dysfunction 9.96 9.70 13 342964 6815 64148940
Sinus bradycardia 9.93 9.70 76 342901 22817 64132938
Ovarian cyst 9.92 9.70 28 342949 10990 64144765
Sigmoidectomy 9.91 9.70 4 342973 20 64155735
Temperature regulation disorder 9.90 9.70 5 342972 4206 64151549
Device leakage 9.89 9.70 18 342959 8248 64147507
Pain in extremity 9.87 9.70 1437 341540 301648 63854107
Dermatitis allergic 9.85 9.70 44 342933 15065 64140690
Lymphopenia 9.85 9.70 88 342889 25569 64130186
Gallbladder injury 9.84 9.70 20 342957 1128 64154627
Acute pulmonary oedema 9.81 9.70 35 342942 12774 64142981
Cystitis haemorrhagic 9.81 9.70 17 342960 7939 64147816
Drug level decreased 9.80 9.70 30 342947 11473 64144282
Bladder cancer 9.80 9.70 28 342949 10946 64144809
Mastocytosis 9.79 9.70 12 342965 436 64155319
Therapy cessation 9.78 9.70 118 342859 32371 64123384
Nystagmus 9.77 9.70 21 342956 9047 64146708
SARS-CoV-2 sepsis 9.75 9.70 7 342970 126 64155629
Haemolytic anaemia 9.73 9.70 48 342929 16005 64139750
Delirium tremens 9.72 9.70 14 342963 596 64155159
Transplant failure 9.70 9.70 4 342973 3790 64151965

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC N02AA05 NERVOUS SYSTEM
ANALGESICS
OPIOIDS
Natural opium alkaloids
ATC N02AA55 NERVOUS SYSTEM
ANALGESICS
OPIOIDS
Natural opium alkaloids
ATC N02AA56 NERVOUS SYSTEM
ANALGESICS
OPIOIDS
Natural opium alkaloids
ATC N02AJ17 NERVOUS SYSTEM
ANALGESICS
OPIOIDS
Opioids in combination with non-opioid analgesics
ATC N02AJ18 NERVOUS SYSTEM
ANALGESICS
OPIOIDS
Opioids in combination with non-opioid analgesics
ATC N02AJ19 NERVOUS SYSTEM
ANALGESICS
OPIOIDS
Opioids in combination with non-opioid analgesics
MeSH PA D000700 Analgesics
MeSH PA D000701 Analgesics, Opioid
MeSH PA D002491 Central Nervous System Agents
MeSH PA D002492 Central Nervous System Depressants
MeSH PA D009294 Narcotics
MeSH PA D018373 Peripheral Nervous System Agents
MeSH PA D018689 Sensory System Agents
CHEBI has role CHEBI:35482 narcotic analgesic
CHEBI has role CHEBI:51177 anti-tussive
CHEBI has role CHEBI:55322 mu-opioid agonists
FDA MoA N0000175684 Full Opioid Agonists
FDA EPC N0000175690 Opioid Agonist

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Severe pain indication 76948002
Acute postoperative pain indication 107401000119105
Chronic Pain with Opioid Tolerance indication
Neuropathic pain off-label use 247398009
Hypophosphatemia contraindication 4996001
Suicidal thoughts contraindication 6471006
Dependent drug abuse contraindication 6525002
Alcoholism contraindication 7200002
Alcohol withdrawal delirium contraindication 8635005
Asthenia contraindication 13791008
Constipation contraindication 14760008 DOID:2089
Mood swings contraindication 18963009
Myocardial infarction contraindication 22298006 DOID:5844
Inflammatory bowel disease contraindication 24526004 DOID:0050589
Alcohol intoxication contraindication 25702006
Shock contraindication 27942005
Hypercapnia contraindication 29596007
Dehydration contraindication 34095006
Hypertensive disorder contraindication 38341003 DOID:10763
Disorder of gallbladder contraindication 39621005 DOID:0060262
Gastrointestinal ulcer contraindication 40845000
Hypothyroidism contraindication 40930008 DOID:1459
Fecal impaction contraindication 44635007
Conduction disorder of the heart contraindication 44808001
Low blood pressure contraindication 45007003
Chronic heart failure contraindication 48447003
Bradycardia contraindication 48867003
Gastrointestinal perforation contraindication 51875005
Vitamin K deficiency contraindication 52675005 DOID:11249
Nasal polyp contraindication 52756005
Acute nephropathy contraindication 58574008
Hepatic failure contraindication 59927004
Diarrhea contraindication 62315008
Ulcerative colitis contraindication 64766004 DOID:8577
Blood coagulation disorder contraindication 64779008 DOID:1247
Substance abuse contraindication 66214007
Benign intracranial hypertension contraindication 68267002 DOID:11459
Hemorrhoids contraindication 70153002 DOID:9746
Poisoning by acetaminophen contraindication 70273001
Factor II deficiency contraindication 73975000
Reye's syndrome contraindication 74351001 DOID:14525
Gastrointestinal hemorrhage contraindication 74474003
Urethral stricture contraindication 76618002
Thrombotic thrombocytopenic purpura contraindication 78129009 DOID:10772
Decreased respiratory function contraindication 80954004
Injury of head contraindication 82271004
Cor pulmonale contraindication 83291003 DOID:8515
Pulmonary emphysema contraindication 87433001
Gout contraindication 90560007 DOID:13189
Kidney disease contraindication 90708001 DOID:557
Hemophilia contraindication 90935002
Anemia due to enzyme deficiency contraindication 111577008
Acute abdominal pain contraindication 116290004
Gastrointestinal obstruction contraindication 126765001
Neoplasm of brain contraindication 126952004 DOID:1319
von Willebrand disorder contraindication 128105004 DOID:12531
Seizure disorder contraindication 128613002
Drug-induced psychosis contraindication 191483003 DOID:1742
Coronary artery bypass graft contraindication 232717009
Disease of liver contraindication 235856003 DOID:409
Chronic diarrhea contraindication 236071009
Aluminum intoxication contraindication 236546003
Morbid obesity contraindication 238136002 DOID:11981
Benign prostatic hyperplasia contraindication 266569009
Retention of urine contraindication 267064002
Anemia contraindication 271737000 DOID:2355
Exacerbation of asthma contraindication 281239006
Pregnancy, function contraindication 289908002
Lesion of brain contraindication 301766008
Thrombocytopenic disorder contraindication 302215000 DOID:1588
Skin irritation contraindication 367466007
Coma contraindication 371632003
Primary adrenocortical insufficiency contraindication 373662000
Operation on gastrointestinal tract contraindication 386621005
Hypoxia contraindication 389086002
Cardiovascular event risk contraindication 395112001
Breastfeeding (mother) contraindication 413712001
Central nervous system depression contraindication 418072004
Dysfunction of sphincter of Oddi contraindication 430887001
Acute erosive gastritis contraindication 444926003
Smokes tobacco daily contraindication 449868002
Acute Thromboembolic Stroke contraindication




๐Ÿถ Veterinary Drug Use

None

๐Ÿถ Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 7.97 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
10MG;20MG TARGINIQ PURDUE PHARMA LP N205777 July 23, 2014 DISCN TABLET, EXTENDED RELEASE ORAL 8969369 May 10, 2022 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
10MG;20MG TARGINIQ PURDUE PHARMA LP N205777 July 23, 2014 DISCN TABLET, EXTENDED RELEASE ORAL 9056051 May 10, 2022 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
10MG;20MG TARGINIQ PURDUE PHARMA LP N205777 July 23, 2014 DISCN TABLET, EXTENDED RELEASE ORAL 9084729 May 10, 2022 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
10MG;20MG TARGINIQ PURDUE PHARMA LP N205777 July 23, 2014 DISCN TABLET, EXTENDED RELEASE ORAL 9161937 May 10, 2022 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
10MG;20MG TARGINIQ PURDUE PHARMA LP N205777 July 23, 2014 DISCN TABLET, EXTENDED RELEASE ORAL 9168252 May 10, 2022 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
10MG;20MG TARGINIQ PURDUE PHARMA LP N205777 July 23, 2014 DISCN TABLET, EXTENDED RELEASE ORAL 9283216 May 10, 2022 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
10MG;20MG TARGINIQ PURDUE PHARMA LP N205777 July 23, 2014 DISCN TABLET, EXTENDED RELEASE ORAL 9283221 May 10, 2022 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
10MG;20MG TARGINIQ PURDUE PHARMA LP N205777 July 23, 2014 DISCN TABLET, EXTENDED RELEASE ORAL 9345701 May 10, 2022 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
10MG;20MG TARGINIQ PURDUE PHARMA LP N205777 July 23, 2014 DISCN TABLET, EXTENDED RELEASE ORAL 9511066 May 10, 2022 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE BY PROVIDING AN ABUSE-DETERRENT ORAL CONTROLLED RELEASE COMBINATION DRUG PRODUCT
20MG;40MG TARGINIQ PURDUE PHARMA LP N205777 July 23, 2014 DISCN TABLET, EXTENDED RELEASE ORAL 8969369 May 10, 2022 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
20MG;40MG TARGINIQ PURDUE PHARMA LP N205777 July 23, 2014 DISCN TABLET, EXTENDED RELEASE ORAL 9056051 May 10, 2022 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
20MG;40MG TARGINIQ PURDUE PHARMA LP N205777 July 23, 2014 DISCN TABLET, EXTENDED RELEASE ORAL 9084729 May 10, 2022 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
20MG;40MG TARGINIQ PURDUE PHARMA LP N205777 July 23, 2014 DISCN TABLET, EXTENDED RELEASE ORAL 9161937 May 10, 2022 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
20MG;40MG TARGINIQ PURDUE PHARMA LP N205777 July 23, 2014 DISCN TABLET, EXTENDED RELEASE ORAL 9168252 May 10, 2022 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
20MG;40MG TARGINIQ PURDUE PHARMA LP N205777 July 23, 2014 DISCN TABLET, EXTENDED RELEASE ORAL 9283216 May 10, 2022 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
20MG;40MG TARGINIQ PURDUE PHARMA LP N205777 July 23, 2014 DISCN TABLET, EXTENDED RELEASE ORAL 9283221 May 10, 2022 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
20MG;40MG TARGINIQ PURDUE PHARMA LP N205777 July 23, 2014 DISCN TABLET, EXTENDED RELEASE ORAL 9345701 May 10, 2022 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
20MG;40MG TARGINIQ PURDUE PHARMA LP N205777 July 23, 2014 DISCN TABLET, EXTENDED RELEASE ORAL 9511066 May 10, 2022 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE BY PROVIDING AN ABUSE-DETERRENT ORAL CONTROLLED RELEASE COMBINATION DRUG PRODUCT
5MG;10MG TARGINIQ PURDUE PHARMA LP N205777 July 23, 2014 DISCN TABLET, EXTENDED RELEASE ORAL 8969369 May 10, 2022 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
5MG;10MG TARGINIQ PURDUE PHARMA LP N205777 July 23, 2014 DISCN TABLET, EXTENDED RELEASE ORAL 9056051 May 10, 2022 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
5MG;10MG TARGINIQ PURDUE PHARMA LP N205777 July 23, 2014 DISCN TABLET, EXTENDED RELEASE ORAL 9084729 May 10, 2022 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
5MG;10MG TARGINIQ PURDUE PHARMA LP N205777 July 23, 2014 DISCN TABLET, EXTENDED RELEASE ORAL 9161937 May 10, 2022 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
5MG;10MG TARGINIQ PURDUE PHARMA LP N205777 July 23, 2014 DISCN TABLET, EXTENDED RELEASE ORAL 9168252 May 10, 2022 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
5MG;10MG TARGINIQ PURDUE PHARMA LP N205777 July 23, 2014 DISCN TABLET, EXTENDED RELEASE ORAL 9283216 May 10, 2022 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
5MG;10MG TARGINIQ PURDUE PHARMA LP N205777 July 23, 2014 DISCN TABLET, EXTENDED RELEASE ORAL 9283221 May 10, 2022 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
5MG;10MG TARGINIQ PURDUE PHARMA LP N205777 July 23, 2014 DISCN TABLET, EXTENDED RELEASE ORAL 9345701 May 10, 2022 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
5MG;10MG TARGINIQ PURDUE PHARMA LP N205777 July 23, 2014 DISCN TABLET, EXTENDED RELEASE ORAL 9511066 May 10, 2022 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE BY PROVIDING AN ABUSE-DETERRENT ORAL CONTROLLED RELEASE COMBINATION DRUG PRODUCT
10MG;20MG TARGINIQ PURDUE PHARMA LP N205777 July 23, 2014 DISCN TABLET, EXTENDED RELEASE ORAL 9555000 April 4, 2023 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
10MG;20MG TARGINIQ PURDUE PHARMA LP N205777 July 23, 2014 DISCN TABLET, EXTENDED RELEASE ORAL 9907793 April 4, 2023 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
5MG;10MG TARGINIQ PURDUE PHARMA LP N205777 July 23, 2014 DISCN TABLET, EXTENDED RELEASE ORAL 9555000 April 4, 2023 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
5MG;10MG TARGINIQ PURDUE PHARMA LP N205777 July 23, 2014 DISCN TABLET, EXTENDED RELEASE ORAL 9907793 April 4, 2023 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
13.5MG XTAMPZA ER COLLEGIUM PHARM INC N208090 April 26, 2016 RX CAPSULE, EXTENDED RELEASE ORAL 10525052 July 7, 2023 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
13.5MG XTAMPZA ER COLLEGIUM PHARM INC N208090 April 26, 2016 RX CAPSULE, EXTENDED RELEASE ORAL 8840928 July 7, 2023 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
13.5MG XTAMPZA ER COLLEGIUM PHARM INC N208090 April 26, 2016 RX CAPSULE, EXTENDED RELEASE ORAL 9248195 July 7, 2023 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
18MG XTAMPZA ER COLLEGIUM PHARM INC N208090 April 26, 2016 RX CAPSULE, EXTENDED RELEASE ORAL 10525052 July 7, 2023 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
18MG XTAMPZA ER COLLEGIUM PHARM INC N208090 April 26, 2016 RX CAPSULE, EXTENDED RELEASE ORAL 8840928 July 7, 2023 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
18MG XTAMPZA ER COLLEGIUM PHARM INC N208090 April 26, 2016 RX CAPSULE, EXTENDED RELEASE ORAL 9248195 July 7, 2023 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
27MG XTAMPZA ER COLLEGIUM PHARM INC N208090 April 26, 2016 RX CAPSULE, EXTENDED RELEASE ORAL 10525052 July 7, 2023 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
27MG XTAMPZA ER COLLEGIUM PHARM INC N208090 April 26, 2016 RX CAPSULE, EXTENDED RELEASE ORAL 8840928 July 7, 2023 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
27MG XTAMPZA ER COLLEGIUM PHARM INC N208090 April 26, 2016 RX CAPSULE, EXTENDED RELEASE ORAL 9248195 July 7, 2023 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
36MG XTAMPZA ER COLLEGIUM PHARM INC N208090 April 26, 2016 RX CAPSULE, EXTENDED RELEASE ORAL 10525052 July 7, 2023 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
36MG XTAMPZA ER COLLEGIUM PHARM INC N208090 April 26, 2016 RX CAPSULE, EXTENDED RELEASE ORAL 8840928 July 7, 2023 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
36MG XTAMPZA ER COLLEGIUM PHARM INC N208090 April 26, 2016 RX CAPSULE, EXTENDED RELEASE ORAL 9248195 July 7, 2023 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
9MG XTAMPZA ER COLLEGIUM PHARM INC N208090 April 26, 2016 RX CAPSULE, EXTENDED RELEASE ORAL 10525052 July 7, 2023 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
9MG XTAMPZA ER COLLEGIUM PHARM INC N208090 April 26, 2016 RX CAPSULE, EXTENDED RELEASE ORAL 8840928 July 7, 2023 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
9MG XTAMPZA ER COLLEGIUM PHARM INC N208090 April 26, 2016 RX CAPSULE, EXTENDED RELEASE ORAL 9248195 July 7, 2023 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
10MG OXYCONTIN PURDUE PHARMA LP N022272 April 5, 2010 RX TABLET, EXTENDED RELEASE ORAL 10130591 Nov. 20, 2023 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
10MG OXYCONTIN PURDUE PHARMA LP N022272 April 5, 2010 RX TABLET, EXTENDED RELEASE ORAL 8309060 Nov. 20, 2023 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
15MG OXYCONTIN PURDUE PHARMA LP N022272 April 5, 2010 RX TABLET, EXTENDED RELEASE ORAL 10130591 Nov. 20, 2023 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
15MG OXYCONTIN PURDUE PHARMA LP N022272 April 5, 2010 RX TABLET, EXTENDED RELEASE ORAL 8309060 Nov. 20, 2023 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
20MG OXYCONTIN PURDUE PHARMA LP N022272 April 5, 2010 RX TABLET, EXTENDED RELEASE ORAL 10130591 Nov. 20, 2023 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
20MG OXYCONTIN PURDUE PHARMA LP N022272 April 5, 2010 RX TABLET, EXTENDED RELEASE ORAL 8309060 Nov. 20, 2023 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
30MG OXYCONTIN PURDUE PHARMA LP N022272 April 5, 2010 RX TABLET, EXTENDED RELEASE ORAL 10130591 Nov. 20, 2023 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
30MG OXYCONTIN PURDUE PHARMA LP N022272 April 5, 2010 RX TABLET, EXTENDED RELEASE ORAL 8309060 Nov. 20, 2023 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
40MG OXYCONTIN PURDUE PHARMA LP N022272 April 5, 2010 RX TABLET, EXTENDED RELEASE ORAL 10130591 Nov. 20, 2023 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
40MG OXYCONTIN PURDUE PHARMA LP N022272 April 5, 2010 RX TABLET, EXTENDED RELEASE ORAL 8309060 Nov. 20, 2023 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
60MG OXYCONTIN PURDUE PHARMA LP N022272 April 5, 2010 RX TABLET, EXTENDED RELEASE ORAL 10130591 Nov. 20, 2023 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
60MG OXYCONTIN PURDUE PHARMA LP N022272 April 5, 2010 RX TABLET, EXTENDED RELEASE ORAL 8309060 Nov. 20, 2023 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
80MG OXYCONTIN PURDUE PHARMA LP N022272 April 5, 2010 RX TABLET, EXTENDED RELEASE ORAL 10130591 Nov. 20, 2023 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
80MG OXYCONTIN PURDUE PHARMA LP N022272 April 5, 2010 RX TABLET, EXTENDED RELEASE ORAL 8309060 Nov. 20, 2023 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
13.5MG XTAMPZA ER COLLEGIUM PHARM INC N208090 April 26, 2016 RX CAPSULE, EXTENDED RELEASE ORAL 8758813 June 10, 2025 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
18MG XTAMPZA ER COLLEGIUM PHARM INC N208090 April 26, 2016 RX CAPSULE, EXTENDED RELEASE ORAL 8758813 June 10, 2025 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
27MG XTAMPZA ER COLLEGIUM PHARM INC N208090 April 26, 2016 RX CAPSULE, EXTENDED RELEASE ORAL 8758813 June 10, 2025 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
36MG XTAMPZA ER COLLEGIUM PHARM INC N208090 April 26, 2016 RX CAPSULE, EXTENDED RELEASE ORAL 8758813 June 10, 2025 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
9MG XTAMPZA ER COLLEGIUM PHARM INC N208090 April 26, 2016 RX CAPSULE, EXTENDED RELEASE ORAL 8758813 June 10, 2025 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
1.2MG;10MG TROXYCA ER PFIZER N207621 Aug. 19, 2016 DISCN CAPSULE, EXTENDED RELEASE ORAL 8685443 July 3, 2025 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG TERM OPIOID TREATMENT BY ORALLY ADMINISTERING A PLURALITY OF COMPOSITE SUBUNITS AS CLAIMED
2.4MG;20MG TROXYCA ER PFIZER N207621 Aug. 19, 2016 DISCN CAPSULE, EXTENDED RELEASE ORAL 8685443 July 3, 2025 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG TERM OPIOID TREATMENT BY ORALLY ADMINISTERING A PLURALITY OF COMPOSITE SUBUNITS AS CLAIMED
3.6MG;30MG TROXYCA ER PFIZER N207621 Aug. 19, 2016 DISCN CAPSULE, EXTENDED RELEASE ORAL 8685443 July 3, 2025 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG TERM OPIOID TREATMENT BY ORALLY ADMINISTERING A PLURALITY OF COMPOSITE SUBUNITS AS CLAIMED
4.8MG;40MG TROXYCA ER PFIZER N207621 Aug. 19, 2016 DISCN CAPSULE, EXTENDED RELEASE ORAL 8685443 July 3, 2025 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG TERM OPIOID TREATMENT BY ORALLY ADMINISTERING A PLURALITY OF COMPOSITE SUBUNITS AS CLAIMED
7.2MG;60MG TROXYCA ER PFIZER N207621 Aug. 19, 2016 DISCN CAPSULE, EXTENDED RELEASE ORAL 8685443 July 3, 2025 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG TERM OPIOID TREATMENT BY ORALLY ADMINISTERING A PLURALITY OF COMPOSITE SUBUNITS AS CLAIMED
9.6MG;80MG TROXYCA ER PFIZER N207621 Aug. 19, 2016 DISCN CAPSULE, EXTENDED RELEASE ORAL 8685443 July 3, 2025 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG TERM OPIOID TREATMENT BY ORALLY ADMINISTERING A PLURALITY OF COMPOSITE SUBUNITS AS CLAIMED
325MG;7.5MG XARTEMIS XR MALLINCKRODT INC N204031 March 11, 2014 DISCN TABLET, EXTENDED RELEASE ORAL 7976870 June 1, 2027 METHOD OF TREATING PATIENTS WITH GASTRIC RETENTIVE DOSAGE FORM
10MG OXYCONTIN PURDUE PHARMA LP N022272 April 5, 2010 RX TABLET, EXTENDED RELEASE ORAL 11304909 Aug. 24, 2027 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
10MG OXYCONTIN PURDUE PHARMA LP N022272 April 5, 2010 RX TABLET, EXTENDED RELEASE ORAL 8808741 Aug. 24, 2027 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
10MG OXYCONTIN PURDUE PHARMA LP N022272 April 5, 2010 RX TABLET, EXTENDED RELEASE ORAL 9492391 Aug. 24, 2027 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
10MG OXYCONTIN PURDUE PHARMA LP N022272 April 5, 2010 RX TABLET, EXTENDED RELEASE ORAL 9492393 Aug. 24, 2027 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
15MG OXYCONTIN PURDUE PHARMA LP N022272 April 5, 2010 RX TABLET, EXTENDED RELEASE ORAL 11304909 Aug. 24, 2027 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
15MG OXYCONTIN PURDUE PHARMA LP N022272 April 5, 2010 RX TABLET, EXTENDED RELEASE ORAL 8808741 Aug. 24, 2027 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
15MG OXYCONTIN PURDUE PHARMA LP N022272 April 5, 2010 RX TABLET, EXTENDED RELEASE ORAL 9492391 Aug. 24, 2027 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
15MG OXYCONTIN PURDUE PHARMA LP N022272 April 5, 2010 RX TABLET, EXTENDED RELEASE ORAL 9492393 Aug. 24, 2027 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
20MG OXYCONTIN PURDUE PHARMA LP N022272 April 5, 2010 RX TABLET, EXTENDED RELEASE ORAL 11304909 Aug. 24, 2027 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
20MG OXYCONTIN PURDUE PHARMA LP N022272 April 5, 2010 RX TABLET, EXTENDED RELEASE ORAL 8808741 Aug. 24, 2027 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
20MG OXYCONTIN PURDUE PHARMA LP N022272 April 5, 2010 RX TABLET, EXTENDED RELEASE ORAL 9492391 Aug. 24, 2027 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
20MG OXYCONTIN PURDUE PHARMA LP N022272 April 5, 2010 RX TABLET, EXTENDED RELEASE ORAL 9492393 Aug. 24, 2027 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
30MG OXYCONTIN PURDUE PHARMA LP N022272 April 5, 2010 RX TABLET, EXTENDED RELEASE ORAL 11304909 Aug. 24, 2027 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
30MG OXYCONTIN PURDUE PHARMA LP N022272 April 5, 2010 RX TABLET, EXTENDED RELEASE ORAL 8808741 Aug. 24, 2027 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
30MG OXYCONTIN PURDUE PHARMA LP N022272 April 5, 2010 RX TABLET, EXTENDED RELEASE ORAL 9492391 Aug. 24, 2027 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
30MG OXYCONTIN PURDUE PHARMA LP N022272 April 5, 2010 RX TABLET, EXTENDED RELEASE ORAL 9492393 Aug. 24, 2027 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
40MG OXYCONTIN PURDUE PHARMA LP N022272 April 5, 2010 RX TABLET, EXTENDED RELEASE ORAL 11304909 Aug. 24, 2027 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
40MG OXYCONTIN PURDUE PHARMA LP N022272 April 5, 2010 RX TABLET, EXTENDED RELEASE ORAL 8808741 Aug. 24, 2027 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
40MG OXYCONTIN PURDUE PHARMA LP N022272 April 5, 2010 RX TABLET, EXTENDED RELEASE ORAL 9492391 Aug. 24, 2027 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
40MG OXYCONTIN PURDUE PHARMA LP N022272 April 5, 2010 RX TABLET, EXTENDED RELEASE ORAL 9492393 Aug. 24, 2027 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
60MG OXYCONTIN PURDUE PHARMA LP N022272 April 5, 2010 RX TABLET, EXTENDED RELEASE ORAL 11304909 Aug. 24, 2027 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
60MG OXYCONTIN PURDUE PHARMA LP N022272 April 5, 2010 RX TABLET, EXTENDED RELEASE ORAL 8808741 Aug. 24, 2027 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
60MG OXYCONTIN PURDUE PHARMA LP N022272 April 5, 2010 RX TABLET, EXTENDED RELEASE ORAL 9492391 Aug. 24, 2027 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
60MG OXYCONTIN PURDUE PHARMA LP N022272 April 5, 2010 RX TABLET, EXTENDED RELEASE ORAL 9492393 Aug. 24, 2027 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
80MG OXYCONTIN PURDUE PHARMA LP N022272 April 5, 2010 RX TABLET, EXTENDED RELEASE ORAL 11304909 Aug. 24, 2027 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
80MG OXYCONTIN PURDUE PHARMA LP N022272 April 5, 2010 RX TABLET, EXTENDED RELEASE ORAL 8808741 Aug. 24, 2027 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
80MG OXYCONTIN PURDUE PHARMA LP N022272 April 5, 2010 RX TABLET, EXTENDED RELEASE ORAL 9492391 Aug. 24, 2027 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
80MG OXYCONTIN PURDUE PHARMA LP N022272 April 5, 2010 RX TABLET, EXTENDED RELEASE ORAL 9492393 Aug. 24, 2027 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
325MG;7.5MG XARTEMIS XR MALLINCKRODT INC N204031 March 11, 2014 DISCN TABLET, EXTENDED RELEASE ORAL 8372432 March 11, 2029 MANAGEMENT OF ACUTE PAIN IN PATIENTS REQUIRING OPIOID ANALGESIA
325MG;7.5MG XARTEMIS XR MALLINCKRODT INC N204031 March 11, 2014 DISCN TABLET, EXTENDED RELEASE ORAL 8668929 March 11, 2029 MANAGEMENT OF ACUTE PAIN IN PATIENTS REQUIRING OPIOID ANALGESIA
325MG;7.5MG XARTEMIS XR MALLINCKRODT INC N204031 March 11, 2014 DISCN TABLET, EXTENDED RELEASE ORAL 8377453 Nov. 19, 2029 MANAGEMENT OF ACUTE PAIN IN PATIENTS REQUIRING OPIOID ANALGESIA
13.5MG XTAMPZA ER COLLEGIUM PHARM INC N208090 April 26, 2016 RX CAPSULE, EXTENDED RELEASE ORAL 10004729 Dec. 10, 2030 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
13.5MG XTAMPZA ER COLLEGIUM PHARM INC N208090 April 26, 2016 RX CAPSULE, EXTENDED RELEASE ORAL 10668060 Dec. 10, 2030 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
13.5MG XTAMPZA ER COLLEGIUM PHARM INC N208090 April 26, 2016 RX CAPSULE, EXTENDED RELEASE ORAL 9682075 Dec. 10, 2030 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
18MG XTAMPZA ER COLLEGIUM PHARM INC N208090 April 26, 2016 RX CAPSULE, EXTENDED RELEASE ORAL 10004729 Dec. 10, 2030 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
18MG XTAMPZA ER COLLEGIUM PHARM INC N208090 April 26, 2016 RX CAPSULE, EXTENDED RELEASE ORAL 10668060 Dec. 10, 2030 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
18MG XTAMPZA ER COLLEGIUM PHARM INC N208090 April 26, 2016 RX CAPSULE, EXTENDED RELEASE ORAL 9682075 Dec. 10, 2030 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
27MG XTAMPZA ER COLLEGIUM PHARM INC N208090 April 26, 2016 RX CAPSULE, EXTENDED RELEASE ORAL 10004729 Dec. 10, 2030 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
27MG XTAMPZA ER COLLEGIUM PHARM INC N208090 April 26, 2016 RX CAPSULE, EXTENDED RELEASE ORAL 10668060 Dec. 10, 2030 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
27MG XTAMPZA ER COLLEGIUM PHARM INC N208090 April 26, 2016 RX CAPSULE, EXTENDED RELEASE ORAL 9682075 Dec. 10, 2030 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
36MG XTAMPZA ER COLLEGIUM PHARM INC N208090 April 26, 2016 RX CAPSULE, EXTENDED RELEASE ORAL 10004729 Dec. 10, 2030 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
36MG XTAMPZA ER COLLEGIUM PHARM INC N208090 April 26, 2016 RX CAPSULE, EXTENDED RELEASE ORAL 10668060 Dec. 10, 2030 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
36MG XTAMPZA ER COLLEGIUM PHARM INC N208090 April 26, 2016 RX CAPSULE, EXTENDED RELEASE ORAL 9682075 Dec. 10, 2030 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
9MG XTAMPZA ER COLLEGIUM PHARM INC N208090 April 26, 2016 RX CAPSULE, EXTENDED RELEASE ORAL 10004729 Dec. 10, 2030 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
9MG XTAMPZA ER COLLEGIUM PHARM INC N208090 April 26, 2016 RX CAPSULE, EXTENDED RELEASE ORAL 10668060 Dec. 10, 2030 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
9MG XTAMPZA ER COLLEGIUM PHARM INC N208090 April 26, 2016 RX CAPSULE, EXTENDED RELEASE ORAL 9682075 Dec. 10, 2030 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
325MG;7.5MG XARTEMIS XR MALLINCKRODT INC N204031 March 11, 2014 DISCN TABLET, EXTENDED RELEASE ORAL 8741885 May 16, 2032 MANAGEMENT OF ACUTE PAIN IN PATIENTS REQUIRING OPIOID ANALGESIA
325MG;7.5MG XARTEMIS XR MALLINCKRODT INC N204031 March 11, 2014 DISCN TABLET, EXTENDED RELEASE ORAL 9468636 May 16, 2032 MANAGEMENT OF ACUTE PAIN IN PATIENTS REQUIRING OPIOID ANALGESIA
13.5MG XTAMPZA ER COLLEGIUM PHARM INC N208090 April 26, 2016 RX CAPSULE, EXTENDED RELEASE ORAL 10188644 Sept. 2, 2036 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
13.5MG XTAMPZA ER COLLEGIUM PHARM INC N208090 April 26, 2016 RX CAPSULE, EXTENDED RELEASE ORAL 10646485 Sept. 2, 2036 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
13.5MG XTAMPZA ER COLLEGIUM PHARM INC N208090 April 26, 2016 RX CAPSULE, EXTENDED RELEASE ORAL 9737530 Sept. 2, 2036 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
13.5MG XTAMPZA ER COLLEGIUM PHARM INC N208090 April 26, 2016 RX CAPSULE, EXTENDED RELEASE ORAL 9968598 Sept. 2, 2036 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
18MG XTAMPZA ER COLLEGIUM PHARM INC N208090 April 26, 2016 RX CAPSULE, EXTENDED RELEASE ORAL 10188644 Sept. 2, 2036 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
18MG XTAMPZA ER COLLEGIUM PHARM INC N208090 April 26, 2016 RX CAPSULE, EXTENDED RELEASE ORAL 10646485 Sept. 2, 2036 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
18MG XTAMPZA ER COLLEGIUM PHARM INC N208090 April 26, 2016 RX CAPSULE, EXTENDED RELEASE ORAL 9737530 Sept. 2, 2036 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
18MG XTAMPZA ER COLLEGIUM PHARM INC N208090 April 26, 2016 RX CAPSULE, EXTENDED RELEASE ORAL 9968598 Sept. 2, 2036 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
27MG XTAMPZA ER COLLEGIUM PHARM INC N208090 April 26, 2016 RX CAPSULE, EXTENDED RELEASE ORAL 10188644 Sept. 2, 2036 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
27MG XTAMPZA ER COLLEGIUM PHARM INC N208090 April 26, 2016 RX CAPSULE, EXTENDED RELEASE ORAL 10646485 Sept. 2, 2036 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
27MG XTAMPZA ER COLLEGIUM PHARM INC N208090 April 26, 2016 RX CAPSULE, EXTENDED RELEASE ORAL 9737530 Sept. 2, 2036 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
27MG XTAMPZA ER COLLEGIUM PHARM INC N208090 April 26, 2016 RX CAPSULE, EXTENDED RELEASE ORAL 9968598 Sept. 2, 2036 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
36MG XTAMPZA ER COLLEGIUM PHARM INC N208090 April 26, 2016 RX CAPSULE, EXTENDED RELEASE ORAL 10188644 Sept. 2, 2036 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
36MG XTAMPZA ER COLLEGIUM PHARM INC N208090 April 26, 2016 RX CAPSULE, EXTENDED RELEASE ORAL 10646485 Sept. 2, 2036 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
36MG XTAMPZA ER COLLEGIUM PHARM INC N208090 April 26, 2016 RX CAPSULE, EXTENDED RELEASE ORAL 9737530 Sept. 2, 2036 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
36MG XTAMPZA ER COLLEGIUM PHARM INC N208090 April 26, 2016 RX CAPSULE, EXTENDED RELEASE ORAL 9968598 Sept. 2, 2036 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
9MG XTAMPZA ER COLLEGIUM PHARM INC N208090 April 26, 2016 RX CAPSULE, EXTENDED RELEASE ORAL 10188644 Sept. 2, 2036 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
9MG XTAMPZA ER COLLEGIUM PHARM INC N208090 April 26, 2016 RX CAPSULE, EXTENDED RELEASE ORAL 10646485 Sept. 2, 2036 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
9MG XTAMPZA ER COLLEGIUM PHARM INC N208090 April 26, 2016 RX CAPSULE, EXTENDED RELEASE ORAL 9737530 Sept. 2, 2036 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
9MG XTAMPZA ER COLLEGIUM PHARM INC N208090 April 26, 2016 RX CAPSULE, EXTENDED RELEASE ORAL 9968598 Sept. 2, 2036 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Mu-type opioid receptor GPCR AGONIST Ki 7.80 WOMBAT-PK CHEMBL
Kappa-type opioid receptor GPCR EC50 4.80 CHEMBL
Delta-type opioid receptor GPCR EC50 5.40 CHEMBL
Mu-type opioid receptor GPCR Ki 7.36 CHEMBL
Mu-type opioid receptor GPCR EC50 6.80 CHEMBL
Delta-type opioid receptor GPCR Ki 5.96 CHEMBL
Kappa-type opioid receptor GPCR Ki 6.49 CHEMBL
Acetylcholinesterase Enzyme IC50 4.12 CHEMBL
Kappa-type opioid receptor GPCR Ki 5.58 CHEMBL
Kappa-type opioid receptor GPCR EC50 4.80 CHEMBL

External reference:

IDSource
D00847 KEGG_DRUG
124-90-3 SECONDARY_CAS_RN
124133-68-2 SECONDARY_CAS_RN
4017996 VANDF
4017997 VANDF
4019870 VANDF
C0030049 UMLSCUI
CHEBI:7852 CHEBI
CHEMBL656 ChEMBL_ID
CHEMBL1200890 ChEMBL_ID
DB00497 DRUGBANK_ID
CHEMBL3989826 ChEMBL_ID
D010098 MESH_DESCRIPTOR_UI
C016026 MESH_SUPPLEMENTAL_RECORD_UI
5284603 PUBCHEM_CID
7093 IUPHAR_LIGAND_ID
1701 INN_ID
CD35PMG570 UNII
159821 RXNORM
10664 MMSL
31648 MMSL
5216 MMSL
5217 MMSL
6369 MMSL
d00329 MMSL
001558 NDDF
001559 NDDF
004513 NDDF
116352007 SNOMEDCT_US
387024006 SNOMEDCT_US
414984009 SNOMEDCT_US
55452001 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
oxycodone hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0054-0390 SOLUTION 5 mg ORAL ANDA 32 sections
Roxicet HUMAN PRESCRIPTION DRUG LABEL 2 0054-3686 SOLUTION 5 mg ORAL ANDA 23 sections
Roxicet HUMAN PRESCRIPTION DRUG LABEL 2 0054-4650 TABLET 5 mg ORAL ANDA 23 sections
Roxicet HUMAN PRESCRIPTION DRUG LABEL 2 0054-8648 SOLUTION 5 mg ORAL ANDA 23 sections
Roxicet HUMAN PRESCRIPTION DRUG LABEL 2 0054-8650 TABLET 5 mg ORAL ANDA 23 sections
Oxycodone Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0093-5731 TABLET, FILM COATED, EXTENDED RELEASE 10 mg ORAL NDA authorized generic 33 sections
Oxycodone Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0093-5732 TABLET, FILM COATED, EXTENDED RELEASE 20 mg ORAL NDA authorized generic 33 sections
Oxycodone Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0093-5733 TABLET, FILM COATED, EXTENDED RELEASE 40 mg ORAL NDA authorized generic 33 sections
Oxycodone Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0093-5734 TABLET, FILM COATED, EXTENDED RELEASE 80 mg ORAL NDA authorized generic 33 sections
OXYCODONE HYDROCHLORIDE HUMAN PRESCRIPTION DRUG LABEL 1 0115-1556 TABLET, FILM COATED, EXTENDED RELEASE 10 mg ORAL NDA AUTHORIZED GENERIC 33 sections
OXYCODONE HYDROCHLORIDE HUMAN PRESCRIPTION DRUG LABEL 1 0115-1557 TABLET, FILM COATED, EXTENDED RELEASE 15 mg ORAL NDA AUTHORIZED GENERIC 33 sections
OXYCODONE HYDROCHLORIDE HUMAN PRESCRIPTION DRUG LABEL 1 0115-1558 TABLET, FILM COATED, EXTENDED RELEASE 20 mg ORAL NDA AUTHORIZED GENERIC 33 sections
OXYCODONE HYDROCHLORIDE HUMAN PRESCRIPTION DRUG LABEL 1 0115-1559 TABLET, FILM COATED, EXTENDED RELEASE 30 mg ORAL NDA AUTHORIZED GENERIC 33 sections
OXYCODONE HYDROCHLORIDE HUMAN PRESCRIPTION DRUG LABEL 1 0115-1560 TABLET, FILM COATED, EXTENDED RELEASE 40 mg ORAL NDA AUTHORIZED GENERIC 33 sections
OXYCODONE HYDROCHLORIDE HUMAN PRESCRIPTION DRUG LABEL 1 0115-1561 TABLET, FILM COATED, EXTENDED RELEASE 60 mg ORAL NDA AUTHORIZED GENERIC 33 sections
OXYCODONE HYDROCHLORIDE HUMAN PRESCRIPTION DRUG LABEL 1 0115-1562 TABLET, FILM COATED, EXTENDED RELEASE 80 mg ORAL NDA AUTHORIZED GENERIC 33 sections
OXYCODONE HYDROCHLORIDE HUMAN PRESCRIPTION DRUG LABEL 1 0121-0826 SOLUTION 100 mg ORAL ANDA 33 sections
OXYCODONE HYDROCHLORIDE HUMAN PRESCRIPTION DRUG LABEL 1 0121-0827 SOLUTION 5 mg ORAL ANDA 35 sections
OXYCODONE HYDROCHLORIDE HUMAN PRESCRIPTION DRUG LABEL 1 0121-4827 SOLUTION 5 mg ORAL ANDA 35 sections
Oxycodone Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0121-4839 SOLUTION 5 mg ORAL ANDA 33 sections
Oxycodone Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0228-2876 TABLET 5 mg ORAL ANDA 29 sections
Oxycodone Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0228-2878 TABLET 15 mg ORAL ANDA 29 sections
Oxycodone Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0228-2879 TABLET 30 mg ORAL ANDA 29 sections
OXYCODONE AND ACETAMINOPHEN HUMAN PRESCRIPTION DRUG LABEL 2 0406-0512 TABLET 5 mg ORAL ANDA 15 sections
OXYCODONE AND ACETAMINOPHEN HUMAN PRESCRIPTION DRUG LABEL 2 0406-0522 TABLET 7.50 mg ORAL ANDA 15 sections
OXYCODONE AND ACETAMINOPHEN HUMAN PRESCRIPTION DRUG LABEL 2 0406-0523 TABLET 10 mg ORAL ANDA 15 sections
OXYCODONE HYDROCHLORIDE HUMAN PRESCRIPTION DRUG LABEL 1 0406-0552 TABLET 5 mg ORAL ANDA 36 sections
OXYCODONE HYDROCHLORIDE HUMAN PRESCRIPTION DRUG LABEL 1 0406-8510 TABLET 10 mg ORAL ANDA 36 sections
OXYCODONE HYDROCHLORIDE HUMAN PRESCRIPTION DRUG LABEL 1 0406-8515 TABLET 15 mg ORAL ANDA 36 sections
OXYCODONE HYDROCHLORIDE HUMAN PRESCRIPTION DRUG LABEL 1 0406-8520 TABLET 20 mg ORAL ANDA 36 sections