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) 166.67 mg/mL Bocci G, Oprea TI, Benet LZ
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 1575.96 9.75 1891 320248 70627 63096256
Completed suicide 1359.56 9.75 2556 319583 143117 63023766
Drug abuser 1270.62 9.75 499 321640 2424 63164459
Muscle injury 1037.83 9.75 1460 320679 63885 63102998
Folliculitis 1031.73 9.75 1513 320626 68804 63098079
Drug dependence 1013.38 9.75 903 321236 23580 63143303
Irritable bowel syndrome 968.73 9.75 1601 320538 80811 63086072
Lower respiratory tract infection 800.02 9.75 1947 320192 130360 63036523
Impaired healing 782.41 9.75 1655 320484 100887 63065996
Respiratory arrest 764.51 9.75 885 321254 31760 63135123
Sleep disorder due to general medical condition, insomnia type 734.78 9.75 1102 321037 51115 63115768
Toxicity to various agents 642.03 9.75 2719 319420 244531 62922352
Stomatitis 623.39 9.75 1829 320310 136896 63029987
Blister 607.84 9.75 1737 320402 128077 63038806
Confusional state 584.03 9.75 2561 319578 233819 62933064
Ill-defined disorder 563.64 9.75 1267 320872 80488 63086395
Gastrointestinal disorder 532.94 9.75 1670 320469 129569 63037314
Overdose 530.10 9.75 1531 320608 113547 63053336
Inadequate analgesia 500.74 9.75 261 321878 2682 63164201
Drug withdrawal syndrome 495.80 9.75 650 321489 26544 63140339
Off label use 458.89 9.75 1817 320322 672645 62494238
Cardio-respiratory arrest 398.46 9.75 916 321223 59043 63107840
Peripheral swelling 339.48 9.75 2411 319728 263531 62903352
Accidental overdose 329.27 9.75 493 321646 22816 63144067
Sinusitis 283.99 9.75 2046 320093 224607 62942276
Cardiac arrest 277.27 9.75 1065 321074 91480 63075403
Therapeutic product effect decreased 272.20 9.75 1795 320344 191392 62975491
Duodenal ulcer perforation 267.36 9.75 1011 321128 86198 63080685
Infection 265.65 9.75 2031 320108 227142 62939741
Death 262.82 9.75 2979 319160 371402 62795481
Helicobacter infection 257.16 9.75 1042 321097 91743 63075140
Substance abuse 253.72 9.75 204 321935 4603 63162280
Weight increased 248.00 9.75 2210 319929 258582 62908301
Respiratory depression 205.11 9.75 298 321841 13417 63153466
Cough 201.15 9.75 784 321355 291959 62874924
Muscle spasticity 199.77 9.75 380 321759 21414 63145469
Night sweats 195.88 9.75 619 321520 48195 63118688
Pruritus 193.67 9.75 2736 319403 358717 62808166
Nasopharyngitis 190.87 9.75 2051 320088 252206 62914677
Drug ineffective 187.73 9.75 3964 318175 1040801 62126082
Contusion 166.60 9.75 1317 320822 148727 63018156
Exposure during pregnancy 162.39 9.75 341 321798 155206 63011677
Condition aggravated 161.82 9.75 1286 320853 400931 62765952
Ear pain 156.05 9.75 470 321669 35648 63131235
Body temperature increased 156.03 9.75 479 321660 36713 63130170
Injection site pain 152.59 9.75 265 321874 129535 63037348
Device expulsion 147.62 9.75 7 322132 34915 63131968
Poisoning 147.31 9.75 256 321883 13444 63153439
Delirium 143.48 9.75 572 321567 49969 63116914
Intentional product misuse 140.22 9.75 647 321492 60270 63106613
Drug screen positive 138.62 9.75 128 322011 3501 63163382
COVID-19 131.04 9.75 233 321906 112870 63054013
Medication error 130.62 9.75 569 321570 51715 63115168
Injection site erythema 127.67 9.75 140 321999 83034 63083849
Joint swelling 123.76 9.75 2342 319797 325324 62841559
Product use issue 122.29 9.75 639 321500 219881 62947002
Abortion spontaneous 120.98 9.75 44 322095 47151 63119732
Respiratory disorder 120.46 9.75 454 321685 38628 63128255
Hyperaesthesia 111.40 9.75 183 321956 9175 63157708
Accidental death 111.02 9.75 87 322052 1889 63164994
Product dose omission issue 110.16 9.75 716 321423 233597 62933286
Plasma cell myeloma 108.93 9.75 415 321724 35490 63131393
Injection site reaction 108.22 9.75 83 322056 58441 63108442
Malaise 105.90 9.75 1480 320659 414474 62752409
Injection site swelling 105.09 9.75 55 322084 47517 63119366
Product use in unapproved indication 103.19 9.75 512 321627 178568 62988315
Treatment failure 102.53 9.75 591 321548 198452 62968431
Pericarditis 99.30 9.75 1063 321076 130516 63036367
Miosis 97.44 9.75 151 321988 7202 63159681
Therapeutic product effect incomplete 96.31 9.75 319 321820 124737 63042146
Mental status changes 93.65 9.75 424 321715 39175 63127708
Headache 89.33 9.75 2489 319650 630752 62536131
Swelling 89.17 9.75 1924 320215 273454 62893429
Red blood cell sedimentation rate abnormal 86.86 9.75 3 322136 19779 63147104
Psoriasis 84.66 9.75 198 321941 86759 63080124
Product complaint 79.92 9.75 191 321948 12618 63154265
Anti-cyclic citrullinated peptide antibody positive 79.08 9.75 920 321219 115292 63051591
Hypersensitivity 79.07 9.75 1994 320145 290691 62876192
Somnolence 77.92 9.75 1307 320832 177378 62989505
Pyrexia 76.53 9.75 3014 319125 467464 62699419
Cardiac failure 76.01 9.75 217 321922 88925 63077958
Nasal congestion 75.37 9.75 136 322003 65524 63101359
Drug resistance 74.88 9.75 13 322126 22920 63143963
Respiratory rate decreased 74.73 9.75 91 322048 3444 63163439
Constipation 74.51 9.75 1577 320562 223366 62943517
Hypertension 74.51 9.75 984 321155 278319 62888564
Drug tolerance 73.60 9.75 129 322010 6820 63160063
Unresponsive to stimuli 72.57 9.75 352 321787 33464 63133419
Maternal exposure during pregnancy 71.56 9.75 742 321397 219320 62947563
Insomnia 70.30 9.75 1506 320633 213746 62953137
Dizziness 69.50 9.75 1656 320483 428269 62738614
Drug interaction 67.57 9.75 790 321349 228341 62938542
Macular degeneration 67.26 9.75 20 322119 24356 63142527
Pleural fibrosis 66.40 9.75 85 322054 3387 63163496
Presbyacusis 64.25 9.75 76 322063 2789 63164094
Injection site pruritus 62.77 9.75 82 322057 45034 63121849
Cataract 62.11 9.75 122 322017 56931 63109952
Exposure via ingestion 61.68 9.75 75 322064 2834 63164049
No adverse event 61.01 9.75 72 322067 41333 63125550
Influenza 60.23 9.75 315 321824 108407 63058476
Foetal exposure during pregnancy 59.50 9.75 45 322094 31917 63134966
Soft tissue disorder 58.86 9.75 91 322048 4331 63162552
Atrial fibrillation 58.59 9.75 349 321790 116287 63050596
Premature delivery 58.50 9.75 41 322098 30240 63136643
Cytomegalovirus infection 58.16 9.75 17 322122 20935 63145948
Withdrawal syndrome 58.09 9.75 228 321911 19769 63147114
Sopor 57.94 9.75 20 322119 22144 63144739
Palpitations 57.40 9.75 336 321803 112434 63054449
Blood magnesium increased 55.95 9.75 73 322066 2965 63163918
Pleural thickening 55.79 9.75 71 322068 2812 63164071
Blood pressure increased 55.75 9.75 539 321600 161523 63005360
Myalgia 54.44 9.75 478 321661 146051 63020832
Drug reaction with eosinophilia and systemic symptoms 54.10 9.75 55 322084 33781 63133102
Oropharyngeal pain 53.32 9.75 272 321867 94215 63072668
Delusional disorder, unspecified type 53.04 9.75 30 322109 367 63166516
Myelosuppression 52.95 9.75 27 322112 23676 63143207
Erythema 52.94 9.75 603 321536 175148 62991735
Syncope 52.45 9.75 364 321775 117021 63049862
Road traffic accident 51.84 9.75 341 321798 36291 63130592
Angioedema 51.84 9.75 103 322036 47862 63119021
Cholecystitis chronic 51.68 9.75 142 321997 10219 63156664
Ear infection 51.59 9.75 71 322068 38142 63128741
Sleep disorder 51.21 9.75 636 321503 80930 63085953
Injury 48.97 9.75 578 321561 72669 63094214
Injection site bruising 48.82 9.75 86 322053 41824 63125059
Discomfort 48.03 9.75 1150 320989 166224 63000659
Acute lung injury 47.96 9.75 49 322090 1522 63165361
Chest discomfort 47.66 9.75 344 321795 109625 63057258
Malignant neoplasm progression 47.20 9.75 630 321509 81491 63085392
Productive cough 46.76 9.75 164 321975 63044 63103839
Bone erosion 46.29 9.75 16 322123 17701 63149182
Anaphylactic reaction 45.94 9.75 176 321963 65924 63100959
Deep vein thrombosis postoperative 45.43 9.75 144 321995 11225 63155658
Pain in extremity 45.26 9.75 1308 320831 330178 62836705
Back pain 45.14 9.75 1702 320437 262443 62904440
Toxic leukoencephalopathy 44.22 9.75 34 322105 717 63166166
Feeling hot 44.09 9.75 121 322018 50233 63116650
Poisoning deliberate 43.84 9.75 141 321998 11077 63155806
Inappropriate schedule of product administration 43.72 9.75 328 321811 103637 63063246
Synovitis 43.69 9.75 1250 320889 185668 62981215
Salpingo-oophorectomy unilateral 43.57 9.75 36 322103 845 63166038
Dependence 43.15 9.75 53 322086 2024 63164859
Asthma 42.30 9.75 428 321711 127133 63039750
Nasal necrosis 42.25 9.75 17 322122 89 63166794
Accidental exposure to product by child 41.59 9.75 40 322099 1153 63165730
Bronchitis 41.50 9.75 419 321720 124516 63042367
Drug ineffective for unapproved indication 40.49 9.75 69 322070 33994 63132889
Mobility decreased 40.38 9.75 406 321733 120753 63046130
Premature baby 40.15 9.75 28 322111 20707 63146176
Deafness neurosensory 40.06 9.75 81 322058 4774 63162109
Rhinorrhoea 39.77 9.75 184 321955 65393 63101490
Immunodeficiency 39.69 9.75 27 322112 20227 63146656
Osteosclerosis 39.66 9.75 71 322068 3817 63163066
Narcotic bowel syndrome 39.36 9.75 18 322121 135 63166748
Creatinine renal clearance decreased 38.85 9.75 17 322122 16291 63150592
Vertigo 38.14 9.75 165 321974 59722 63107161
Product formulation issue 38.11 9.75 28 322111 550 63166333
Abdominal pain upper 37.63 9.75 1340 320799 205104 62961779
Hepatitis 37.60 9.75 92 322047 39696 63127187
Lip dry 37.59 9.75 167 321972 15303 63151580
C-reactive protein increased 36.93 9.75 305 321834 94402 63072481
Bone cyst 36.68 9.75 51 322088 2203 63164680
Lactic acidosis 36.60 9.75 88 322051 38199 63128684
Facet joint syndrome 36.56 9.75 140 321999 11998 63154885
Device difficult to use 36.22 9.75 10 322129 12786 63154097
Joint stiffness 35.62 9.75 102 322037 41767 63125116
Hypoglycaemia 35.56 9.75 170 321969 59895 63106988
Stress 35.31 9.75 198 321941 66969 63099914
Epigastric discomfort 34.90 9.75 94 322045 6686 63160197
Device dislocation 34.46 9.75 48 322091 25657 63141226
Flushing 33.94 9.75 232 321907 74855 63092028
Cardiac failure congestive 33.67 9.75 303 321836 92130 63074753
Hepatic enzyme increased 33.66 9.75 1300 320839 201028 62965855
Enthesopathy 33.41 9.75 108 322031 8506 63158377
Drug screen negative 33.28 9.75 20 322119 276 63166607
Vomiting 33.28 9.75 3283 318856 556334 62610549
Spinal cord ischaemia 33.12 9.75 11 322128 29 63166854
Oesophageal motility disorder 33.12 9.75 22 322117 365 63166518
Haematochezia 32.60 9.75 150 321989 53394 63113489
Maternal exposure timing unspecified 32.29 9.75 94 322045 6993 63159890
Neutropenia 32.23 9.75 660 321479 174345 62992538
Sedation complication 32.00 9.75 15 322124 13807 63153076
Serotonin syndrome 31.91 9.75 252 321887 28430 63138453
Deep vein thrombosis 31.87 9.75 600 321539 83200 63083683
Diabetes mellitus 31.86 9.75 160 321979 55650 63111233
Musculoskeletal stiffness 31.46 9.75 705 321434 183913 62982970
Tooth loss 31.30 9.75 91 322048 6765 63160118
Epistaxis 31.26 9.75 228 321911 72497 63094386
Depressed level of consciousness 31.15 9.75 465 321674 61613 63105270
Drug-induced liver injury 30.67 9.75 103 322036 40119 63126764
Hypotension 30.64 9.75 1103 321036 271501 62895382
Toxicologic test abnormal 30.63 9.75 27 322112 694 63166189
Pulmonary embolism 30.56 9.75 792 321347 115892 63050991
Lupus-like syndrome 30.49 9.75 20 322119 15275 63151608
Compartment syndrome 30.40 9.75 47 322092 2237 63164646
Secretion discharge 30.35 9.75 12 322127 12219 63154664
Tongue disorder 30.22 9.75 120 322019 10460 63156423
Bradypnoea 30.21 9.75 60 322079 3490 63163393
Foetal megacystis 30.21 9.75 10 322129 26 63166857
Cognitive disorder 30.18 9.75 163 321976 55652 63111231
Drug diversion 29.73 9.75 30 322109 918 63165965
Arrhythmia 29.54 9.75 97 322042 38043 63128840
Cancer pain 29.51 9.75 56 322083 3149 63163734
Hyponatraemia 29.50 9.75 395 321744 111505 63055378
Wrong technique in product usage process 29.49 9.75 190 321949 62150 63104733
Orthostatic hypotension 29.38 9.75 90 322049 36070 63130813
Epilepsy 29.35 9.75 58 322081 27007 63139876
Sinusitis fungal 29.16 9.75 41 322098 1790 63165093
Coma 28.09 9.75 471 321668 63893 63102990
Aplastic anaemia 28.00 9.75 7 322132 9562 63157321
Coeliac disease 27.96 9.75 15 322124 12782 63154101
Liver function test increased 27.86 9.75 80 322059 32731 63134152
Complication of device insertion 27.73 9.75 3 322136 7561 63159322
Upper respiratory tract infection 27.72 9.75 274 321865 81773 63085110
Toxic epidermal necrolysis 27.72 9.75 54 322085 25280 63141603
Sphincter of Oddi dysfunction 27.70 9.75 20 322119 382 63166501
Rheumatoid factor positive 27.64 9.75 284 321855 84122 63082761
Mouth ulceration 27.59 9.75 81 322058 32903 63133980
Autoimmune disorder 27.48 9.75 165 321974 17012 63149871
Victim of homicide 27.27 9.75 11 322128 58 63166825
Abortion induced 27.19 9.75 9 322130 10233 63156650
Eye pruritus 26.94 9.75 33 322106 18638 63148245
Hepatotoxicity 26.80 9.75 97 322042 36944 63129939
Drug use disorder 26.56 9.75 70 322069 4914 63161969
Melaena 26.55 9.75 73 322066 30292 63136591
COVID-19 pneumonia 26.46 9.75 20 322119 14189 63152694
Injection site warmth 26.28 9.75 23 322116 15172 63151711
Acute kidney injury 26.26 9.75 1081 321058 262334 62904549
Multiple organ dysfunction syndrome 25.82 9.75 175 321964 56577 63110306
Red blood cell sedimentation rate 25.69 9.75 68 322071 4786 63162097
Lethargy 25.60 9.75 413 321726 55594 63111289
Sleep disorder due to a general medical condition 25.60 9.75 15 322124 12173 63154710
Urinary tract infection 25.58 9.75 1090 321049 263594 62903289
Maternal exposure before pregnancy 25.51 9.75 4 322135 7599 63159284
Sinus disorder 25.45 9.75 54 322085 24499 63142384
Viral infection 25.40 9.75 94 322045 35569 63131314
Injection site rash 25.33 9.75 35 322104 18774 63148109
Sputum increased 25.20 9.75 45 322094 2414 63164469
Angina pectoris 25.06 9.75 74 322065 30004 63136879
Throat irritation 25.04 9.75 102 322037 37545 63129338
Blood glucose increased 24.95 9.75 288 321851 83468 63083415
Balance disorder 24.87 9.75 291 321848 84131 63082752
Femur fracture 24.82 9.75 118 322021 41638 63125245
Circulatory collapse 24.67 9.75 46 322093 21892 63144991
Breast cancer stage I 24.59 9.75 3 322136 6886 63159997
Emotional distress 24.54 9.75 263 321876 32286 63134597
Dyspnoea exertional 24.52 9.75 192 321947 60110 63106773
Brain injury 24.39 9.75 85 322054 6958 63159925
Renal impairment 24.35 9.75 309 321830 88046 63078837
Tenosynovitis 24.34 9.75 136 322003 13659 63153224
Oesophageal achalasia 24.33 9.75 20 322119 466 63166417
Pneumocystis jirovecii pneumonia 24.29 9.75 30 322109 16884 63149999
Fluid retention 24.29 9.75 190 321949 59496 63107387
Infusion site pain 24.15 9.75 30 322109 16839 63150044
Bradycardia 24.14 9.75 246 321893 72981 63093902
Breast cancer female 24.09 9.75 20 322119 13539 63153344
Status epilepticus 24.08 9.75 25 322114 15208 63151675
Device issue 24.07 9.75 53 322086 23728 63143155
Drug detoxification 23.98 9.75 17 322122 315 63166568
Pulmonary arterial hypertension 23.95 9.75 49 322090 22528 63144355
Injection site haemorrhage 23.94 9.75 55 322084 24259 63142624
Haemophagocytic lymphohistiocytosis 23.89 9.75 12 322127 10615 63156268
Hand deformity 23.84 9.75 1013 321126 158444 63008439
Cystitis 23.83 9.75 172 321967 54819 63112064
Foetal death 23.80 9.75 13 322126 10967 63155916
Dermatitis allergic 23.79 9.75 25 322114 15123 63151760
Accidental poisoning 23.69 9.75 22 322117 606 63166277
Glaucoma 23.68 9.75 37 322102 18868 63148015
Secondary amyloidosis 23.65 9.75 12 322127 116 63166767
Anaphylactic shock 23.65 9.75 53 322086 23580 63143303
Respiratory tract infection 23.63 9.75 119 322020 41364 63125519
Injection site urticaria 23.51 9.75 22 322117 14051 63152832
Clear cell renal cell carcinoma 23.28 9.75 33 322106 1452 63165431
Underdose 23.27 9.75 67 322072 27389 63139494
Myopathy 23.18 9.75 14 322125 11177 63155706
Fibromyalgia 23.18 9.75 553 321586 79867 63087016
Sickle cell anaemia with crisis 23.05 9.75 75 322064 5928 63160955
Transplant rejection 23.02 9.75 13 322126 10767 63156116
Injection site mass 22.91 9.75 37 322102 18619 63148264
Alanine aminotransferase abnormal 22.74 9.75 62 322077 4442 63162441
Haemorrhage 22.67 9.75 199 321940 60823 63106060
Cerebral haemorrhage 22.54 9.75 80 322059 30649 63136234
Tachycardia 22.22 9.75 444 321695 117712 63049171
Blood pressure fluctuation 21.99 9.75 141 321998 46176 63120707
Haematotoxicity 21.98 9.75 10 322129 9366 63157517
Non-small cell lung cancer 21.77 9.75 53 322086 3542 63163341
Gait disturbance 21.75 9.75 736 321403 182442 62984441
Caesarean section 21.65 9.75 33 322106 16999 63149884
Anoxia 21.62 9.75 14 322125 222 63166661
Cerebrovascular accident 21.51 9.75 402 321737 107622 63059261
Septic shock 21.48 9.75 225 321914 66404 63100479
Diffuse cutaneous mastocytosis 21.44 9.75 5 322134 0 63166883
Myoclonus 21.42 9.75 146 321993 15722 63151161
Dyspepsia 21.39 9.75 377 321762 101819 63065064
Injection site induration 21.38 9.75 10 322129 9216 63157667
Lower limb fracture 21.29 9.75 202 321937 24019 63142864
Incorrect route of product administration 21.25 9.75 223 321916 27229 63139654
Urticaria 21.04 9.75 1036 321103 164766 63002117
Spleen congestion 21.02 9.75 11 322128 114 63166769
Velopharyngeal incompetence 20.93 9.75 7 322132 19 63166864
Embolism venous 20.73 9.75 48 322091 3106 63163777
Spinal operation 20.64 9.75 90 322049 8181 63158702
Swelling face 20.61 9.75 214 321925 63261 63103622
Presyncope 20.61 9.75 72 322067 27713 63139170
Seizure 20.50 9.75 514 321625 132120 63034763
Paraesthesia 20.47 9.75 623 321516 156343 63010540
Colitis microscopic 20.32 9.75 11 322128 9328 63157555
Product residue present 20.31 9.75 55 322084 3924 63162959
Faecalith 20.28 9.75 6 322133 9 63166874
Wound 20.27 9.75 1018 321121 162245 63004638
Cervix neoplasm 20.19 9.75 13 322126 204 63166679
Therapeutic response decreased 20.15 9.75 207 321932 61318 63105565
Needle issue 20.11 9.75 14 322125 10362 63156521
Inflammatory marker increased 20.02 9.75 5 322134 6834 63160049
Hypoxia 20.01 9.75 420 321719 59372 63107511
Hypomania 19.79 9.75 4 322135 6326 63160557
Cardiotoxicity 19.78 9.75 9 322130 8429 63158454
Extrapyramidal disorder 19.68 9.75 23 322116 13261 63153622
Pallor 19.60 9.75 84 322055 30484 63136399
Hypercalcaemia 19.59 9.75 225 321914 28097 63138786
Osteoporosis 19.57 9.75 191 321948 57147 63109736
Sinus congestion 19.51 9.75 39 322100 18084 63148799
Peripheral venous disease 19.48 9.75 140 321999 15337 63151546
Joint destruction 19.44 9.75 4 322135 6248 63160635
Therapeutic response shortened 19.37 9.75 19 322120 11869 63155014
Small intestinal obstruction 19.25 9.75 159 321980 18178 63148705
Premature labour 19.23 9.75 21 322118 12483 63154400
Unintended pregnancy 19.12 9.75 4 322135 6175 63160708
Rash 18.96 9.75 3179 318960 557692 62609191
Vasculitis 18.91 9.75 40 322099 18169 63148714
Lung cancer metastatic 18.90 9.75 41 322098 2539 63164344
Agranulocytosis 18.73 9.75 65 322074 25069 63141814
Congenital central hypoventilation syndrome 18.71 9.75 7 322132 29 63166854
Immune reconstitution inflammatory syndrome 18.70 9.75 4 322135 6080 63160803
Gun shot wound 18.68 9.75 11 322128 146 63166737
Fall 18.54 9.75 1726 320413 390608 62776275
Gastrointestinal haemorrhage 18.44 9.75 295 321844 80881 63086002
Impaired reasoning 18.38 9.75 9 322130 80 63166803
Ulcer 18.33 9.75 208 321931 25899 63140984
Device breakage 18.18 9.75 19 322120 11523 63155360
Hypertensive crisis 18.13 9.75 31 322108 15255 63151628
Hypersomnia 18.13 9.75 155 321984 17900 63148983
Gestational diabetes 18.11 9.75 10 322129 8386 63158497
Myelodysplastic syndrome 18.08 9.75 36 322103 16718 63150165
Rash erythematous 17.92 9.75 134 322005 42376 63124507
Red blood cell sedimentation rate increased 17.90 9.75 140 321999 43842 63123041
Paraesthesia oral 17.82 9.75 45 322094 19211 63147672
Oral herpes 17.75 9.75 70 322069 26004 63140879
Leukoencephalopathy 17.73 9.75 56 322083 4357 63162526
Progressive multifocal leukoencephalopathy 17.61 9.75 24 322115 12947 63153936
Snake bite 17.53 9.75 5 322134 6 63166877
Full blood count abnormal 17.49 9.75 92 322047 31625 63135258
Mucosal inflammation 17.45 9.75 153 321986 46775 63120108
Ischaemic stroke 17.38 9.75 41 322098 17916 63148967
Sneezing 17.31 9.75 42 322097 18176 63148707
Lip swelling 17.19 9.75 90 322049 30973 63135910
Allodynia 17.18 9.75 21 322118 798 63166085
Mandibular mass 17.18 9.75 11 322128 171 63166712
Paranoid personality disorder 17.16 9.75 4 322135 0 63166883
Learning disability 17.04 9.75 12 322127 220 63166663
Failure to thrive 16.96 9.75 77 322062 7121 63159762
Granulocytopenia 16.89 9.75 4 322135 5668 63161215
Demyelination 16.82 9.75 7 322132 6913 63159970
Symptom masked 16.80 9.75 20 322119 739 63166144
Renal mass 16.79 9.75 37 322102 2316 63164567
Mean cell haemoglobin decreased 16.77 9.75 3 322136 5176 63161707
Rash papular 16.72 9.75 34 322105 15668 63151215
Rash pustular 16.71 9.75 8 322131 7274 63159609
Hypercholesterolaemia 16.70 9.75 54 322085 21280 63145603
Paranoia 16.69 9.75 109 322030 11570 63155313
Pneumonia viral 16.66 9.75 82 322057 7840 63159043
Encephalopathy 16.62 9.75 282 321857 38338 63128545
Complication of device removal 16.60 9.75 3 322136 5139 63161744
Colitis ulcerative 16.54 9.75 72 322067 26019 63140864
Malignant melanoma 16.46 9.75 20 322119 11336 63155547
Suicide attempt 16.43 9.75 214 321925 60704 63106179
Alopecia 16.36 9.75 1482 320657 336054 62830829
Smear cervix abnormal 16.34 9.75 42 322097 2904 63163979
Foetal growth restriction 16.29 9.75 9 322130 7544 63159339
Drug tolerance increased 16.28 9.75 12 322127 237 63166646
Uveitis 16.27 9.75 24 322115 12529 63154354
Blood parathyroid hormone decreased 16.27 9.75 95 322044 9696 63157187
Chemical burn 16.25 9.75 15 322124 410 63166473
Acne 16.19 9.75 62 322077 23231 63143652
Eosinophilia 16.19 9.75 60 322079 22696 63144187
Low birth weight baby 16.10 9.75 8 322131 7121 63159762
Arthropathy 16.09 9.75 1392 320747 233400 62933483
Renal failure 16.08 9.75 464 321675 117188 63049695
Diverticulitis 16.06 9.75 126 322013 39431 63127452
Proteinuria 16.02 9.75 47 322092 19098 63147785
Pain 16.02 9.75 4108 318031 736520 62430363
Gamma-glutamyltransferase increased 15.95 9.75 104 322035 33927 63132956
Foot deformity 15.81 9.75 80 322059 27773 63139110
Injection site extravasation 15.76 9.75 13 322126 8828 63158055
Food allergy 15.57 9.75 21 322118 11380 63155503
Photosensitivity reaction 15.52 9.75 33 322106 14961 63151922
Multiple sclerosis relapse 15.51 9.75 164 321975 48314 63118569
Lactobacillus infection 15.48 9.75 7 322132 51 63166832
Cardiac disorder 15.42 9.75 174 321965 50642 63116241
Epstein-Barr virus infection 15.42 9.75 11 322128 8039 63158844
Product storage error 15.41 9.75 33 322106 14923 63151960
Splenic injury 15.28 9.75 11 322128 209 63166674
C-reactive protein 15.28 9.75 57 322082 4825 63162058
Type 2 diabetes mellitus 15.22 9.75 230 321909 63638 63103245
Therapy partial responder 15.21 9.75 19 322120 10639 63156244
Faecaloma 15.16 9.75 80 322059 7861 63159022
Performance enhancing product use 15.11 9.75 5 322134 13 63166870
Ileus 15.09 9.75 127 322012 14598 63152285
Drug dose omission by device 15.08 9.75 3 322136 4798 63162085
Onychomycosis 14.98 9.75 11 322128 7921 63158962
Tuberculosis 14.96 9.75 21 322118 11190 63155693
Spinal cord operation 14.93 9.75 4 322135 3 63166880
Pancytopenia 14.88 9.75 376 321763 96557 63070326
Respiratory symptom 14.87 9.75 44 322095 3303 63163580
Diastolic hypotension 14.80 9.75 8 322131 89 63166794
Therapeutic product effect increased 14.79 9.75 24 322115 1191 63165692
Bronchiectasis 14.72 9.75 38 322101 16104 63150779
Laryngitis 14.68 9.75 41 322098 16926 63149957
Swollen tongue 14.52 9.75 110 322029 34690 63132193
Sputum discoloured 14.52 9.75 39 322100 16308 63150575
Visual impairment 14.50 9.75 322 321817 84124 63082759
Infusion site erythema 14.49 9.75 23 322116 11656 63155227
Parkinsonism 14.49 9.75 19 322120 10420 63156463
Euphoric mood 14.42 9.75 56 322083 4831 63162052
Hysterectomy 14.41 9.75 90 322049 9409 63157474
Foreign body embolism 14.40 9.75 4 322135 4 63166879
Glomerular filtration rate decreased 14.40 9.75 29 322110 13412 63153471
Breakthrough pain 14.34 9.75 24 322115 1222 63165661
Dry mouth 14.31 9.75 506 321633 77357 63089526
Skin reaction 14.29 9.75 34 322105 14815 63152068
Loss of personal independence in daily activities 14.24 9.75 380 321759 96910 63069973
Breast cancer 14.16 9.75 167 321972 48216 63118667
Breast cancer metastatic 14.15 9.75 107 322032 11911 63154972
Torsade de pointes 14.14 9.75 29 322110 13322 63153561
Transaminases increased 14.13 9.75 97 322042 31270 63135613
Dental restoration failure 14.11 9.75 21 322118 966 63165917
Pemphigoid 14.11 9.75 10 322129 7334 63159549
Depressed mood 14.09 9.75 133 322006 40058 63126825
Eye infection 14.07 9.75 25 322114 12120 63154763
Pneumonia aspiration 14.07 9.75 250 321889 34290 63132593
Pulmonary infarction 14.05 9.75 38 322101 2709 63164174
Electrocardiogram QT prolonged 13.97 9.75 215 321924 59315 63107568
Incorrect dose administered 13.93 9.75 217 321922 59751 63107132
Skin cancer 13.93 9.75 23 322116 11472 63155411
Jaundice 13.91 9.75 89 322050 29162 63137721
Skin plaque 13.91 9.75 13 322126 8307 63158576
Judgement impaired 13.80 9.75 19 322120 813 63166070
Panniculitis 13.76 9.75 102 322037 11283 63155600
Hypervolaemia 13.74 9.75 86 322053 28327 63138556
Illness 13.73 9.75 171 321968 48888 63117995
Skin exfoliation 13.71 9.75 146 321993 42956 63123927
Ischaemic hepatitis 13.68 9.75 32 322107 2084 63164799
Tonsillitis 13.63 9.75 6 322133 5729 63161154
Polycystic ovaries 13.62 9.75 3 322136 4468 63162415
Motor dysfunction 13.54 9.75 21 322118 10740 63156143
Central nervous system stimulation 13.47 9.75 6 322133 42 63166841
Granuloma skin 13.47 9.75 81 322058 8356 63158527
Injection site discolouration 13.43 9.75 12 322127 7836 63159047
Interstitial lung disease 13.40 9.75 227 321912 61681 63105202
Bronchospasm 13.34 9.75 44 322095 17236 63149647
Dental caries 13.28 9.75 97 322042 10682 63156201
Diarrhoea 13.22 9.75 3326 318813 712040 62454843
Ventricular septal defect 13.21 9.75 3 322136 4375 63162508
Nail disorder 13.18 9.75 29 322110 12986 63153897
Myocardial infarction 13.14 9.75 396 321743 99497 63067386
Eosinophil count increased 13.11 9.75 22 322117 10906 63155977
Aspergillus infection 13.11 9.75 13 322126 8080 63158803
Cardiovascular disorder 13.08 9.75 25 322114 11787 63155096
Post procedural pulmonary embolism 12.94 9.75 11 322128 269 63166614
Carpal tunnel syndrome 12.86 9.75 58 322081 20759 63146124
Gastrooesophageal reflux disease 12.86 9.75 378 321761 95261 63071622
Haemoptysis 12.86 9.75 89 322050 28637 63138246
Polyneuropathy 12.81 9.75 35 322104 14554 63152329
Gingival bleeding 12.78 9.75 28 322111 12559 63154324
Gallbladder disorder 12.73 9.75 149 321990 18693 63148190
Drug specific antibody present 12.69 9.75 3 322136 4256 63162627
Patent ductus arteriosus 12.65 9.75 3 322136 4247 63162636
Aphthous ulcer 12.57 9.75 33 322106 13905 63152978
Partial seizures 12.54 9.75 7 322132 5835 63161048
Retinitis 12.49 9.75 8 322131 6188 63160695
Infusion site swelling 12.35 9.75 19 322120 9751 63157132
Cardiogenic shock 12.29 9.75 48 322091 17884 63148999
Acute myocardial infarction 12.27 9.75 104 322035 32020 63134863
Ocular hyperaemia 12.22 9.75 76 322063 25068 63141815
Pneumonia 12.17 9.75 2085 320054 454682 62712201
Bone density decreased 12.14 9.75 36 322103 14576 63152307
Emphysema 12.11 9.75 96 322043 10842 63156041
Hallucination 12.08 9.75 364 321775 54453 63112430
Hypoventilation 12.07 9.75 52 322087 4702 63162181
Blood potassium increased 12.02 9.75 144 321995 18165 63148718
Stool analysis abnormal 12.00 9.75 6 322133 56 63166827
Hallucination, synaesthetic 12.00 9.75 6 322133 56 63166827
Rhinitis allergic 11.98 9.75 26 322113 11701 63155182
Metastases to bone 11.96 9.75 161 321978 20858 63146025
Breathing-related sleep disorder 11.94 9.75 7 322132 92 63166791
Post laminectomy syndrome 11.94 9.75 11 322128 300 63166583
Blood test abnormal 11.93 9.75 40 322099 15589 63151294
Pathogen resistance 11.92 9.75 9 322130 6389 63160494
Rectal haemorrhage 11.88 9.75 176 321963 48854 63118029
Leukopenia neonatal 11.87 9.75 5 322134 30 63166853
Dysphonia 11.85 9.75 170 321969 47444 63119439
Normal newborn 11.76 9.75 15 322124 8326 63158557
Hypoacusis 11.73 9.75 73 322066 24078 63142805
Brain scan abnormal 11.73 9.75 11 322128 307 63166576
Respiratory acidosis 11.71 9.75 66 322073 6649 63160234
Opiates positive 11.71 9.75 12 322127 374 63166509
Drug level below therapeutic 11.71 9.75 5 322134 4861 63162022
Urine abnormality 11.69 9.75 11 322128 7008 63159875
Limb traumatic amputation 11.67 9.75 4 322135 12 63166871
Genital haemorrhage 11.63 9.75 12 322127 7320 63159563
Angiokeratoma 11.58 9.75 8 322131 142 63166741
Central nervous system injury 11.53 9.75 8 322131 143 63166740
Cardiac failure chronic 11.52 9.75 4 322135 4414 63162469
Bladder cancer 11.48 9.75 7 322132 5559 63161324
Glycosylated haemoglobin increased 11.45 9.75 29 322110 12369 63154514
Urinary bladder rupture 11.39 9.75 8 322131 146 63166737
Hepatic cytolysis 11.37 9.75 40 322099 15367 63151516
Sensitivity to weather change 11.30 9.75 12 322127 7225 63159658
Heavy menstrual bleeding 11.29 9.75 49 322090 17724 63149159
Proctalgia 11.29 9.75 61 322078 6049 63160834
Nystagmus 11.27 9.75 9 322130 6211 63160672
Transient ischaemic attack 11.17 9.75 130 322009 37623 63129260
Cyst 11.13 9.75 115 322024 13984 63152899
Hyperprolactinaemia 11.13 9.75 3 322136 3897 63162986
Wheezing 11.13 9.75 385 321754 95210 63071673
Gastroenteritis 11.12 9.75 84 322055 26506 63140377
Dermatitis exfoliative 11.07 9.75 7 322132 5452 63161431
Blood iron abnormal 11.03 9.75 3 322136 3873 63163010
Diabetic ketoacidosis 11.02 9.75 60 322079 20445 63146438
Ventricular tachycardia 10.99 9.75 58 322081 19921 63146962
Hemiparesis 10.99 9.75 71 322068 23211 63143672
Weight decreased 10.97 9.75 1233 320906 275565 62891318
Amenorrhoea 10.96 9.75 21 322118 9893 63156990
Organising pneumonia 10.92 9.75 8 322131 5768 63161115
Joint range of motion decreased 10.92 9.75 228 321911 32200 63134683
Insurance issue 10.91 9.75 9 322130 6112 63160771
Drug level increased 10.90 9.75 69 322070 22667 63144216
Blood creatine phosphokinase MB increased 10.89 9.75 21 322118 1195 63165688
Device use error 10.87 9.75 8 322131 5753 63161130
Intentional self-injury 10.81 9.75 81 322058 25606 63141277
Venous recanalisation 10.80 9.75 3 322136 3 63166880
Postnatal growth restriction 10.80 9.75 4 322135 16 63166867
Coccydynia 10.79 9.75 25 322114 1618 63165265
Polyarthritis 10.78 9.75 22 322117 10124 63156759
Pelvic venous thrombosis 10.77 9.75 26 322113 1729 63165154
Hepatitis B 10.75 9.75 3 322136 3809 63163074
Oesophageal obstruction 10.74 9.75 14 322125 568 63166315
Ovarian cyst 10.73 9.75 43 322096 15902 63150981
Blood testosterone increased 10.68 9.75 8 322131 162 63166721
Joint dislocation 10.67 9.75 54 322085 18746 63148137
Mastocytosis 10.67 9.75 14 322125 572 63166311
Body temperature decreased 10.62 9.75 60 322079 20259 63146624
Generalised tonic-clonic seizure 10.61 9.75 95 322044 28921 63137962
Papule 10.61 9.75 8 322131 5683 63161200
Abdominal wall cyst 10.56 9.75 5 322134 41 63166842
Conjunctivitis 10.55 9.75 62 322077 20734 63146149
Febrile bone marrow aplasia 10.51 9.75 13 322126 7312 63159571
Female genital tract fistula 10.47 9.75 70 322069 7489 63159394
Cytomegalovirus viraemia 10.45 9.75 8 322131 5641 63161242
Wrong patient 10.45 9.75 9 322130 224 63166659
Bradyphrenia 10.43 9.75 12 322127 6968 63159915
Intermenstrual bleeding 10.42 9.75 15 322124 7911 63158972
Febrile neutropenia 10.36 9.75 493 321646 117956 63048927
Child abuse 10.35 9.75 3 322136 4 63166879
Seasonal allergy 10.35 9.75 63 322076 20887 63145996
Upper-airway cough syndrome 10.32 9.75 27 322112 11391 63155492
Device malfunction 10.30 9.75 51 322088 17806 63149077
Eye disorder 10.29 9.75 70 322069 22615 63144268
Hypothalamic pituitary adrenal axis suppression 10.27 9.75 8 322131 172 63166711
Depression 10.24 9.75 1143 320996 195349 62971534
Hyperthyroidism 10.24 9.75 39 322100 14634 63152249
Aplasia pure red cell 10.19 9.75 5 322134 4482 63162401
Euglycaemic diabetic ketoacidosis 10.16 9.75 3 322136 3671 63163212
Thyroid disorder 10.13 9.75 41 322098 15121 63151762
Optic neuritis 10.10 9.75 17 322122 8418 63158465
Eyelid oedema 10.08 9.75 24 322115 10455 63156428
Abdominal distension 10.04 9.75 349 321790 86266 63080617
Anosmia 10.03 9.75 12 322127 6848 63160035
Cerebrospinal fluid leakage 9.99 9.75 20 322119 1170 63165713
Muscular weakness 9.97 9.75 513 321626 121840 63045043
Spinal nerve stimulator implantation 9.96 9.75 7 322132 128 63166755
Acute graft versus host disease 9.96 9.75 5 322134 4423 63162460
Alcohol use 9.88 9.75 28 322111 2051 63164832
Skin ulcer 9.80 9.75 287 321852 42758 63124125
Heart rate irregular 9.77 9.75 70 322069 22351 63144532

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 2214.35 10.45 2701 186490 96395 34671345
Drug abuser 2145.41 10.45 807 188384 3147 34764593
Drug dependence 1789.89 10.45 1288 187903 22929 34744811
Toxicity to various agents 987.91 10.45 2841 186350 197521 34570219
Respiratory arrest 898.40 10.45 924 188267 27119 34740621
Completed suicide 826.21 10.45 1712 187479 96456 34671284
Drug withdrawal syndrome 824.26 10.45 754 188437 19080 34748660
Overdose 810.04 10.45 1625 187566 89434 34678306
Accidental overdose 764.45 10.45 728 188463 19412 34748328
Substance abuse 632.75 10.45 436 188755 7205 34760535
Inadequate analgesia 579.19 10.45 295 188896 2680 34765060
Off label use 360.43 10.45 1123 188068 418401 34349339
Cardio-respiratory arrest 315.88 10.45 829 188362 54444 34713296
Delirium 286.04 10.45 693 188498 43298 34724442
Intentional product misuse 283.29 10.45 706 188485 44905 34722835
Poisoning 274.71 10.45 335 188856 11891 34755849
Respiratory depression 257.08 10.45 375 188816 15870 34751870
Cardiac arrest 255.19 10.45 1114 188077 95045 34672695
Miosis 230.19 10.45 271 188920 9264 34758476
Constipation 223.67 10.45 1386 187805 135596 34632144
Malignant neoplasm progression 213.31 10.45 993 188198 87053 34680687
Death 205.31 10.45 3154 186037 394895 34372845
Somnolence 186.14 10.45 1132 188059 109984 34657756
Drug screen positive 183.73 10.45 160 189031 3783 34763957
Product use in unapproved indication 175.52 10.45 227 188964 117272 34650468
Unresponsive to stimuli 158.92 10.45 415 188776 27154 34740586
Drug tolerance 154.96 10.45 127 189064 2755 34764985
Accidental death 152.98 10.45 118 189073 2338 34765402
Plasma cell myeloma 151.08 10.45 536 188655 41501 34726239
Nausea 144.16 10.45 2610 186581 337298 34430442
Gun shot wound 142.35 10.45 84 189107 1044 34766696
Coma 120.09 10.45 528 188663 45150 34722590
Drug ineffective 119.97 10.45 1747 187444 455004 34312736
Mental status changes 118.00 10.45 463 188728 37620 34730120
C-reactive protein abnormal 113.77 10.45 184 189007 8526 34759214
Exposure via ingestion 104.65 10.45 90 189101 2091 34765649
Toxic leukoencephalopathy 102.23 10.45 48 189143 358 34767382
Confusional state 101.22 10.45 1209 187982 142951 34624789
Drug use disorder 97.66 10.45 117 189074 4074 34763666
COVID-19 94.44 10.45 172 189019 77378 34690362
Depressed level of consciousness 87.14 10.45 460 188731 42381 34725359
Cytomegalovirus infection 86.38 10.45 18 189173 26117 34741623
Cardiac failure 85.25 10.45 234 188957 91014 34676726
Drug resistance 83.37 10.45 19 189172 25908 34741832
Withdrawal syndrome 80.65 10.45 196 188995 12259 34755481
Narcotic bowel syndrome 80.50 10.45 30 189161 113 34767627
Foetal exposure during pregnancy 77.27 10.45 56 189135 38045 34729695
Cardiogenic shock 77.09 10.45 24 189167 26594 34741146
Lactic acidosis 70.65 10.45 51 189140 34721 34733019
Drug interaction 70.07 10.45 834 188357 225112 34542628
Road traffic accident 69.21 10.45 230 188961 17220 34750520
Sedation 67.18 10.45 258 188933 20748 34746992
Product use issue 66.91 10.45 152 189039 63064 34704676
Angioedema 65.84 10.45 63 189128 37311 34730429
Terminal state 65.42 10.45 93 189098 3841 34763899
Cough 65.26 10.45 510 188681 149630 34618110
Drug reaction with eosinophilia and systemic symptoms 63.77 10.45 51 189140 32961 34734779
Depression 62.33 10.45 801 188390 96297 34671443
Hyperaesthesia 62.09 10.45 99 189092 4531 34763209
Vomiting 61.93 10.45 1766 187425 245855 34521885
Respiratory rate decreased 61.89 10.45 70 189121 2289 34765451
Drug tolerance increased 61.52 10.45 36 189155 440 34767300
Sickle cell anaemia with crisis 60.42 10.45 91 189100 3962 34763778
Toxicologic test abnormal 58.86 10.45 37 189154 519 34767221
Bradypnoea 57.91 10.45 74 189117 2755 34764985
Dependence 56.28 10.45 48 189143 1102 34766638
Product complaint 55.68 10.45 108 189083 5782 34761958
Condition aggravated 55.57 10.45 720 188471 191476 34576264
Lethargy 55.40 10.45 397 188794 40725 34727015
Asthma 54.27 10.45 92 189099 42564 34725176
Drug diversion 54.24 10.45 42 189149 837 34766903
Delusional disorder, unspecified type 54.01 10.45 39 189152 696 34767044
Therapeutic product effect incomplete 53.09 10.45 122 189069 50419 34717321
Paroxysmal sympathetic hyperactivity 50.86 10.45 16 189175 30 34767710
Anxiety 50.84 10.45 788 188403 98640 34669100
Acute kidney injury 50.78 10.45 1260 187931 303728 34464012
Toxic epidermal necrolysis 50.55 10.45 27 189164 21619 34746121
Enthesopathy 50.38 10.45 90 189101 4523 34763217
Eosinophilia 50.04 10.45 41 189150 26181 34741559
Epilepsy 49.92 10.45 27 189164 21468 34746272
Neutropenia 49.58 10.45 576 188615 156202 34611538
Hyperhidrosis 49.23 10.45 626 188565 75066 34692674
Leukopenia 48.93 10.45 175 189016 62681 34705059
Decreased appetite 48.80 10.45 1212 187979 165180 34602560
Neuroleptic malignant syndrome 48.75 10.45 18 189173 17916 34749824
Tenosynovitis 48.43 10.45 88 189103 4482 34763258
Product dose omission issue 47.73 10.45 416 188775 119295 34648445
Injection site pain 46.14 10.45 88 189103 38917 34728823
Back pain 45.75 10.45 919 188272 120870 34646870
Intestinal sepsis 45.68 10.45 34 189157 637 34767103
Cancer pain 45.66 10.45 64 189127 2608 34765132
Apparent death 44.91 10.45 75 189116 3569 34764171
Myelosuppression 42.17 10.45 26 189165 19239 34748501
Pulmonary thrombosis 42.15 10.45 111 189080 7296 34760444
Breakthrough pain 40.91 10.45 30 189161 549 34767191
Foreign body reaction 39.72 10.45 14 189177 43 34767697
Renal impairment 39.66 10.45 324 188867 94189 34673551
Substance dependence 39.32 10.45 25 189166 358 34767382
Atrial fibrillation 39.32 10.45 448 188743 121945 34645795
Ventricular fibrillation 38.92 10.45 40 189151 22914 34744826
Cerebral haemorrhage 38.61 10.45 82 189109 34855 34732885
Melaena 38.30 10.45 84 189107 35296 34732444
Tongue disorder 37.80 10.45 87 189104 5252 34762488
Piloerection 37.44 10.45 19 189172 171 34767569
Joint arthroplasty 37.23 10.45 34 189157 857 34766883
Deep vein thrombosis 37.20 10.45 527 188664 64721 34703019
Acute myocardial infarction 37.04 10.45 157 189034 53562 34714178
Pain 36.97 10.45 1405 187786 203270 34564470
Drug hypersensitivity 36.60 10.45 626 188565 79903 34687837
Weight increased 35.44 10.45 327 188864 92706 34675034
Bradycardia 35.19 10.45 251 188940 75167 34692573
Syncope 35.03 10.45 321 188870 91130 34676610
Proteinuria 34.52 10.45 30 189161 18612 34749128
Aspergillus infection 33.81 10.45 12 189179 12242 34755498
Cardiac failure congestive 33.78 10.45 288 188903 82982 34684758
Impaired driving ability 33.54 10.45 55 189136 2578 34765162
Hypoglycaemia 33.34 10.45 167 189024 54473 34713267
Bone pain 32.82 10.45 208 188983 20478 34747262
Spinal fracture 32.60 10.45 102 189089 7396 34760344
Pathogen resistance 32.45 10.45 6 189185 9476 34758264
Apnoea 32.12 10.45 94 189097 6570 34761170
Sopor 31.63 10.45 13 189178 12123 34755617
Respiratory tract infection 31.59 10.45 36 189155 19676 34748064
Incorrect route of product administration 31.27 10.45 161 189030 14684 34753056
Angina pectoris 31.11 10.45 78 189113 31285 34736455
Neoplasm malignant 30.88 10.45 199 188992 19706 34748034
Intervertebral disc degeneration 30.44 10.45 90 189101 6327 34761413
Transplant rejection 30.39 10.45 9 189182 10302 34757438
Thrombocytopenia 30.31 10.45 630 188561 155617 34612123
Emotional distress 30.30 10.45 161 189030 14865 34752875
Labelled drug-drug interaction medication error 30.23 10.45 22 189169 14917 34752823
Drug screen negative 29.76 10.45 16 189175 164 34767576
Multiple organ dysfunction syndrome 29.65 10.45 268 188923 76298 34691442
Pruritus 29.48 10.45 566 188625 141415 34626325
Compartment syndrome 29.34 10.45 56 189135 2962 34764778
Nasopharyngitis 29.28 10.45 240 188951 69728 34698012
Psoriasis 28.92 10.45 110 189081 38702 34729038
Self-medication 28.58 10.45 52 189139 2651 34765089
Neoplasm progression 28.56 10.45 220 188971 23080 34744660
Intestinal pseudo-obstruction 28.44 10.45 41 189150 1715 34766025
Medication error 28.40 10.45 236 188955 25329 34742411
Toxic skin eruption 28.40 10.45 13 189178 11372 34756368
Accident 28.08 10.45 75 189116 4972 34762768
Amnestic disorder 27.32 10.45 17 189174 234 34767506
Seizure 27.31 10.45 401 188790 104456 34663284
Rib fracture 26.82 10.45 151 189040 14249 34753491
Pulmonary embolism 26.64 10.45 655 188536 89091 34678649
Schizophrenia 26.59 10.45 7 189184 8659 34759081
Deafness neurosensory 26.36 10.45 52 189139 2819 34764921
Hepatic pain 26.34 10.45 36 189155 1432 34766308
Post laminectomy syndrome 26.31 10.45 15 189176 174 34767566
Product formulation issue 26.29 10.45 23 189168 547 34767193
Thrombosis 26.18 10.45 401 188790 50057 34717683
COVID-19 pneumonia 26.10 10.45 32 189159 16935 34750805
Drug detoxification 25.89 10.45 17 189174 258 34767482
Disease recurrence 25.84 10.45 48 189143 21442 34746298
Pulmonary congestion 25.41 10.45 144 189047 13621 34754119
Pupillary reflex impaired 25.39 10.45 36 189155 1483 34766257
Sinus tachycardia 25.37 10.45 171 189020 17189 34750551
Compression fracture 25.31 10.45 53 189138 2999 34764741
Circulatory collapse 25.29 10.45 47 189144 20991 34746749
Tooth loss 25.28 10.45 61 189130 3797 34763943
Immune reconstitution inflammatory syndrome 25.18 10.45 8 189183 8751 34758989
Drug ineffective for unapproved indication 25.10 10.45 57 189134 23658 34744082
Lip swelling 25.09 10.45 30 189161 16050 34751690
Dehydration 25.08 10.45 899 188292 129070 34638670
Septic shock 24.62 10.45 259 188932 71575 34696165
Aplastic anaemia 24.38 10.45 11 189180 9705 34758035
Agitation 24.21 10.45 441 188750 56958 34710782
Agranulocytosis 23.82 10.45 59 189132 23762 34743978
Alcohol use 23.74 10.45 54 189137 3234 34764506
Bladder cancer 23.70 10.45 32 189159 16246 34751494
Nephropathy toxic 23.62 10.45 20 189171 12568 34755172
Loss of consciousness 23.55 10.45 600 188591 82067 34685673
Urinary retention 23.52 10.45 300 188891 35988 34731752
Back injury 23.45 10.45 61 189130 3980 34763760
Blood pressure fluctuation 23.37 10.45 65 189126 25184 34742556
Serotonin syndrome 23.22 10.45 186 189005 19747 34747993
Cardiac failure chronic 23.00 10.45 7 189184 7872 34759868
Inappropriate schedule of product administration 22.84 10.45 221 188970 62075 34705665
Victim of homicide 22.74 10.45 12 189179 118 34767622
Tuberculosis 22.66 10.45 9 189182 8568 34759172
Nasal necrosis 22.64 10.45 9 189182 42 34767698
Post transplant lymphoproliferative disorder 22.62 10.45 4 189187 6524 34761216
Alanine aminotransferase abnormal 22.47 10.45 66 189125 4622 34763118
Hypercalcaemia 22.39 10.45 152 189039 15316 34752424
Hypogammaglobulinaemia 22.37 10.45 7 189184 7733 34760007
Feeling abnormal 22.34 10.45 473 188718 62762 34704978
Metastatic renal cell carcinoma 22.24 10.45 40 189151 2021 34765719
Postmortem blood drug level abnormal 22.18 10.45 16 189175 285 34767455
Arthropathy 22.16 10.45 233 188958 26674 34741066
Pancreatitis acute 22.12 10.45 78 189113 28063 34739677
Lower respiratory tract infection 22.09 10.45 92 189099 31545 34736195
Nervousness 22.05 10.45 130 189061 12476 34755264
Drug-induced liver injury 21.95 10.45 81 189110 28751 34738989
Diabetic ketoacidosis 21.92 10.45 40 189151 17992 34749748
Device issue 21.67 10.45 13 189178 9764 34757976
Brain death 21.56 10.45 46 189145 2637 34765103
Subarachnoid haemorrhage 21.44 10.45 22 189169 12613 34755127
Irritability 21.38 10.45 216 188975 24474 34743266
Chronic kidney disease 21.30 10.45 133 189058 41077 34726663
Pathological fracture 21.22 10.45 62 189129 4329 34763411
Gastrointestinal haemorrhage 21.12 10.45 344 188847 88133 34679607
Interstitial lung disease 21.06 10.45 482 188709 64800 34702940
BK virus infection 21.05 10.45 3 189188 5735 34762005
Premature baby 20.93 10.45 47 189144 19586 34748154
Neutrophil count increased 20.88 10.45 38 189153 17108 34750632
Hypoaesthesia 20.87 10.45 457 188734 60987 34706753
Hepatotoxicity 20.87 10.45 54 189137 21431 34746309
Cardiac failure acute 20.83 10.45 16 189175 10554 34757186
Myasthenia gravis 20.56 10.45 6 189185 6934 34760806
Lumbar radiculopathy 20.39 10.45 24 189167 820 34766920
Opiates positive 20.15 10.45 20 189171 561 34767179
Thermophobia 20.14 10.45 9 189182 59 34767681
Venoocclusive liver disease 20.02 10.45 9 189182 7957 34759783
Dental caries 19.97 10.45 62 189129 4477 34763263
Red blood cell sedimentation rate increased 19.74 10.45 100 189091 9062 34758678
Injection site swelling 19.64 10.45 20 189171 11507 34756233
Bone disorder 19.59 10.45 76 189115 6139 34761601
Ileus 19.24 10.45 154 189037 16345 34751395
Obstructive airways disorder 19.17 10.45 34 189157 15460 34752280
Myoclonus 19.15 10.45 141 189050 14584 34753156
Acute chest syndrome 19.12 10.45 23 189168 804 34766936
Diabetes mellitus 19.05 10.45 162 189029 46711 34721029
Blood phosphorus increased 18.97 10.45 9 189182 7712 34760028
Colitis ulcerative 18.90 10.45 38 189153 16482 34751258
Signet-ring cell carcinoma 18.79 10.45 5 189186 3 34767737
Myalgia 18.78 10.45 331 188860 83779 34683961
Blood pressure decreased 18.78 10.45 183 189008 51332 34716408
Dizziness 18.75 10.45 979 188212 217542 34550198
Aplasia pure red cell 18.73 10.45 5 189186 6127 34761613
Tachyphylaxis 18.69 10.45 11 189180 136 34767604
Pseudarthrosis 18.64 10.45 9 189182 72 34767668
Small intestinal obstruction 18.57 10.45 141 189050 14725 34753015
Disease progression 18.54 10.45 738 188453 107339 34660401
Atrioventricular block complete 18.50 10.45 14 189177 9305 34758435
Cerebral infarction 18.46 10.45 81 189110 27374 34740366
Non-small cell lung cancer 18.44 10.45 55 189136 3885 34763855
Therapy partial responder 18.39 10.45 15 189176 9601 34758139
Infusion related reaction 18.30 10.45 191 189000 52866 34714874
Spinal fusion surgery 18.26 10.45 25 189166 996 34766744
Eosinophil count increased 18.17 10.45 12 189179 8560 34759180
Aptyalism 18.17 10.45 16 189175 384 34767356
Environmental exposure 18.12 10.45 14 189177 278 34767462
Formication 18.09 10.45 33 189158 1686 34766054
Spinal laminectomy 18.08 10.45 14 189177 279 34767461
Stevens-Johnson syndrome 17.99 10.45 47 189144 18592 34749148
Anaemia 17.88 10.45 1057 188134 232278 34535462
General physical health deterioration 17.87 10.45 543 188648 127726 34640014
Mucormycosis 17.86 10.45 5 189186 5937 34761803
Dyspnoea exertional 17.85 10.45 149 189042 43130 34724610
Hallucination 17.80 10.45 384 188807 51114 34716626
Tendonitis 17.79 10.45 97 189094 9043 34758697
Learning disability 17.78 10.45 15 189176 339 34767401
Progressive multifocal leukoencephalopathy 17.73 10.45 16 189175 9748 34757992
Shock 17.71 10.45 69 189122 24110 34743630
Spinal operation 17.66 10.45 45 189146 2899 34764841
Atrial septal defect 17.58 10.45 9 189182 7383 34760357
Ventricular tachycardia 17.51 10.45 79 189112 26500 34741240
Hypophagia 17.48 10.45 203 188988 23819 34743921
Spinal cord ischaemia 17.37 10.45 9 189182 85 34767655
Hypoxic-ischaemic encephalopathy 17.32 10.45 59 189132 4473 34763267
Epistaxis 17.24 10.45 217 188974 58034 34709706
Artery dissection 17.17 10.45 10 189181 121 34767619
Granulocytopenia 17.17 10.45 7 189184 6560 34761180
Poisoning deliberate 17.17 10.45 86 189105 7758 34759982
Productive cough 17.07 10.45 127 189064 37686 34730054
Renal cell carcinoma 16.96 10.45 63 189128 4985 34762755
Myocarditis 16.95 10.45 30 189161 13652 34754088
Chest discomfort 16.95 10.45 201 188990 54329 34713411
Bone marrow failure 16.94 10.45 91 189100 29162 34738578
Decreased gait velocity 16.92 10.45 11 189180 164 34767576
Acute graft versus host disease 16.89 10.45 7 189184 6496 34761244
Tumour pain 16.88 10.45 25 189166 1072 34766668
Red blood cell sedimentation rate 16.76 10.45 26 189165 1162 34766578
Haematochezia 16.67 10.45 166 189025 46368 34721372
Stomatitis 16.67 10.45 323 188868 42191 34725549
Adenovirus infection 16.61 10.45 4 189187 5253 34762487
Blood pressure increased 16.54 10.45 357 188834 87745 34679995
Bronchopulmonary aspergillosis 16.53 10.45 34 189157 14625 34753115
Metabolic encephalopathy 16.51 10.45 56 189135 4236 34763504
Parkinsonism 16.44 10.45 12 189179 8126 34759614
Sleep disorder due to a general medical condition 16.44 10.45 4 189187 5217 34762523
Acute hepatic failure 16.42 10.45 32 189159 14042 34753698
Transaminases increased 16.34 10.45 82 189109 26741 34740999
Appendicitis 16.15 10.45 35 189156 14772 34752968
Electrocardiogram QT prolonged 15.99 10.45 143 189048 40809 34726931
Pemphigoid 15.98 10.45 14 189177 8652 34759088
Myelodysplastic syndrome 15.94 10.45 52 189139 19156 34748584
Lymphoma 15.88 10.45 27 189164 12480 34755260
Yawning 15.80 10.45 17 189174 525 34767215
Hospitalisation 15.73 10.45 215 188976 56687 34711053
Hypertensive heart disease 15.70 10.45 38 189153 2370 34765370
Device leakage 15.65 10.45 8 189183 6567 34761173
Cerebral haematoma 15.62 10.45 3 189188 4612 34763128
Inflammatory marker increased 15.54 10.45 4 189187 5024 34762716
Glomerular filtration rate decreased 15.54 10.45 29 189162 12932 34754808
Anaphylactic shock 15.53 10.45 40 189151 15901 34751839
Injection site erythema 15.41 10.45 40 189151 15859 34751881
Therapeutic product effect decreased 15.38 10.45 269 188922 34474 34733266
Arteriosclerosis coronary artery 15.36 10.45 118 189073 12367 34755373
Granuloma skin 15.33 10.45 26 189165 1253 34766487
Myocardial infarction 15.33 10.45 519 188672 120566 34647174
Extrapyramidal disorder 15.28 10.45 29 189162 12851 34754889
Dyspnoea 15.27 10.45 1796 187395 374986 34392754
Eczema 15.24 10.45 50 189141 18386 34749354
Influenza virus test positive 15.17 10.45 9 189182 113 34767627
Hypertriglyceridaemia 15.16 10.45 14 189177 8434 34759306
Lymphopenia 15.15 10.45 42 189149 16293 34751447
Wheezing 15.12 10.45 147 189044 41255 34726485
Hypertensive crisis 15.12 10.45 15 189176 8736 34759004
Ejection fraction decreased 15.12 10.45 53 189138 19101 34748639
Intervertebral disc protrusion 15.11 10.45 99 189092 9857 34757883
Lung cancer metastatic 15.08 10.45 41 189150 2746 34764994
Concomitant disease aggravated 15.03 10.45 6 189185 5695 34762045
Insomnia 15.02 10.45 697 188494 103210 34664530
Blood triglycerides increased 15.01 10.45 34 189157 14125 34753615
Snoring 14.99 10.45 46 189145 3300 34764440
Metastases to spine 14.98 10.45 39 189152 2545 34765195
Blood uric acid increased 14.96 10.45 18 189173 9606 34758134
Decubitus ulcer 14.96 10.45 91 189100 8830 34758910
Oesophageal carcinoma 14.90 10.45 17 189174 9287 34758453
Suicidal ideation 14.88 10.45 304 188887 40084 34727656
Failure to anastomose 14.87 10.45 11 189180 204 34767536
Syringe issue 14.87 10.45 6 189185 5658 34762082
Polyneuropathy 14.81 10.45 37 189154 14859 34752881
Near death experience 14.71 10.45 9 189182 120 34767620
Oropharyngeal pain 14.71 10.45 122 189069 35363 34732377
Photosensitivity reaction 14.68 10.45 103 189088 10491 34757249
Exposure during pregnancy 14.66 10.45 16 189175 8918 34758822
Lymphadenopathy 14.63 10.45 92 189099 28371 34739369
Pupil fixed 14.62 10.45 31 189160 1770 34765970
Hyperkalaemia 14.57 10.45 276 188915 69113 34698627
Mania 14.57 10.45 18 189173 9493 34758247
Acute graft versus host disease in skin 14.51 10.45 5 189186 5196 34762544
Status epilepticus 14.44 10.45 29 189162 12585 34755155
Prostate cancer 14.39 10.45 141 189050 39508 34728232
Anaphylactic reaction 14.34 10.45 109 189082 32192 34735548
Nasal congestion 14.33 10.45 70 189121 22987 34744753
Vestibular ischaemia 14.27 10.45 5 189186 15 34767725
Tremor neonatal 14.24 10.45 14 189177 388 34767352
Cerebrovascular accident 14.14 10.45 350 188841 84461 34683279
Cytomegalovirus infection reactivation 14.14 10.45 5 189186 5113 34762627
Injection site reaction 14.05 10.45 31 189160 13002 34754738
Pyrexia 14.05 10.45 1583 187608 331430 34436310
Hepatitis 14.04 10.45 74 189117 23830 34743910
Hypersensitivity 14.00 10.45 239 188952 60796 34706944
Failure to thrive 13.96 10.45 87 189104 8514 34759226
Kidney transplant rejection 13.96 10.45 12 189179 7485 34760255
Jaundice 13.96 10.45 108 189083 31774 34735966
Red blood cell sedimentation rate abnormal 13.96 10.45 47 189144 3542 34764198
Eye pruritus 13.93 10.45 12 189179 7477 34760263
Brain injury 13.91 10.45 68 189123 6074 34761666
Coronary artery disease 13.90 10.45 181 189010 48124 34719616
Upper gastrointestinal haemorrhage 13.90 10.45 81 189110 25437 34742303
Carbon dioxide abnormal 13.78 10.45 10 189181 180 34767560
Aspiration 13.77 10.45 113 189078 12081 34755659
Eyelid ptosis 13.75 10.45 7 189184 5759 34761981
Hypopnoea 13.74 10.45 35 189156 2254 34765486
Delirium tremens 13.72 10.45 17 189174 613 34767127
Therapeutic response shortened 13.60 10.45 12 189179 7392 34760348
Haemodynamic instability 13.58 10.45 19 189172 9504 34758236
Metastases to bone 13.56 10.45 111 189080 11859 34755881
Haematuria 13.54 10.45 190 189001 49876 34717864
Drug withdrawal maintenance therapy 13.38 10.45 8 189183 102 34767638
Neutrophilia 13.36 10.45 3 189188 4134 34763606
Fungal infection 13.32 10.45 43 189148 15892 34751848
Generalised tonic-clonic seizure 13.32 10.45 64 189127 21110 34746630
Hyponatraemia 13.32 10.45 343 188848 82348 34685392
Foetal growth restriction 13.27 10.45 3 189188 4114 34763626
Graft versus host disease 13.25 10.45 23 189168 10546 34757194
Back disorder 13.23 10.45 71 189120 6580 34761160
Glycosylated haemoglobin increased 13.11 10.45 26 189165 11334 34756406
Injection site mass 13.09 10.45 10 189181 6616 34761124
Sarcopenia 13.08 10.45 14 189177 430 34767310
Atelectasis 12.98 10.45 150 189041 17577 34750163
Androgen deficiency 12.97 10.45 10 189181 198 34767542
Blood alkaline phosphatase increased 12.96 10.45 239 188952 30936 34736804
Allodynia 12.88 10.45 19 189172 812 34766928
Product counterfeit 12.84 10.45 9 189182 153 34767587
Cataract 12.77 10.45 86 189105 26100 34741640
Heart rate decreased 12.77 10.45 110 189081 31635 34736105
Intentional overdose 12.72 10.45 318 188873 43356 34724384
Hand amputation 12.67 10.45 3 189188 0 34767740
Analgesic drug level decreased 12.67 10.45 3 189188 0 34767740
Lumbosacral plexopathy 12.67 10.45 3 189188 0 34767740
Drug eruption 12.60 10.45 60 189131 19838 34747902
Bronchiectasis 12.59 10.45 21 189170 9780 34757960
Salivary hypersecretion 12.58 10.45 17 189174 8627 34759113
Partial seizures 12.57 10.45 5 189186 4755 34762985
Performance status decreased 12.56 10.45 50 189141 4087 34763653
Pulmonary tuberculosis 12.54 10.45 5 189186 4749 34762991
Blood pressure systolic abnormal 12.48 10.45 3 189188 3945 34763795
Viral infection 12.46 10.45 51 189140 17572 34750168
Acute coronary syndrome 12.44 10.45 35 189156 13510 34754230
No adverse event 12.36 10.45 73 189118 22854 34744886
Musculoskeletal stiffness 12.32 10.45 178 189013 46502 34721238
Loss of personal independence in daily activities 12.31 10.45 250 188941 32929 34734811
Convulsions local 12.30 10.45 5 189186 25 34767715
Blood pH decreased 12.30 10.45 34 189157 2300 34765440
Bradykinesia 12.22 10.45 3 189188 3890 34763850
Cyanosis 12.19 10.45 114 189077 12650 34755090
Intraocular pressure increased 12.15 10.45 7 189184 5376 34762364
Paranoia 12.14 10.45 109 189082 11959 34755781
Facet joint syndrome 12.05 10.45 11 189180 277 34767463
Blood glucose increased 12.05 10.45 272 188919 66446 34701294
Pulmonary granuloma 12.03 10.45 26 189165 1504 34766236
Medical device pain 12.02 10.45 6 189185 52 34767688
Pupillary light reflex tests abnormal 11.99 10.45 8 189183 125 34767615
Face oedema 11.92 10.45 28 189163 11488 34756252
Toothache 11.91 10.45 67 189124 6321 34761419
Myelopathy 11.82 10.45 35 189156 2462 34765278
Palpitations 11.81 10.45 149 189042 39837 34727903
Blood creatinine increased 11.80 10.45 408 188783 94568 34673172
Faecaloma 11.80 10.45 59 189132 5318 34762422
Coronary artery bypass 11.61 10.45 6 189185 4896 34762844
Refusal of treatment by patient 11.61 10.45 56 189135 4976 34762764
Influenza 11.55 10.45 194 188997 49472 34718268
Blood parathyroid hormone decreased 11.47 10.45 25 189166 1455 34766285
Basal cell carcinoma 11.47 10.45 61 189130 19597 34748143
Rash 11.41 10.45 1044 188147 221708 34546032
Herpes zoster 11.41 10.45 255 188936 34144 34733596
Gastric haemorrhage 11.40 10.45 24 189167 10237 34757503
Stress 11.40 10.45 107 189084 30240 34737500
Lumbar vertebral fracture 11.37 10.45 33 189158 2296 34765444
Mitral valve incompetence 11.36 10.45 42 189149 14901 34752839
Mesothelioma 11.33 10.45 13 189178 432 34767308
Myofascial pain syndrome 11.30 10.45 12 189179 365 34767375
Spinal cord compression 11.25 10.45 47 189144 3928 34763812
Bronchospasm 11.18 10.45 26 189165 10705 34757035
Carbon monoxide poisoning 11.15 10.45 7 189184 98 34767642
Victim of crime 11.15 10.45 12 189179 371 34767369
Acidosis 11.09 10.45 99 189092 10846 34756894
Visceral oedema 11.09 10.45 7 189184 99 34767641
Renal cancer metastatic 11 10.45 14 189177 519 34767221
Dry eye 10.98 10.45 22 189169 9553 34758187
Pulmonary arterial hypertension 10.97 10.45 19 189172 8720 34759020
Underdose 10.96 10.45 38 189153 13742 34753998
Haemophagocytic lymphohistiocytosis 10.85 10.45 35 189156 12938 34754802
Blood creatine phosphokinase increased 10.83 10.45 174 189017 44683 34723057
Bone lesion 10.82 10.45 38 189153 2925 34764815
Nephrosclerosis 10.82 10.45 19 189172 942 34766798
Product storage error 10.81 10.45 17 189174 8105 34759635
Bronchitis 10.73 10.45 161 189030 41802 34725938
Prescribed underdose 10.70 10.45 20 189171 8913 34758827
Abdominal neoplasm 10.69 10.45 12 189179 389 34767351
Metabolic acidosis 10.69 10.45 169 189022 43511 34724229
Knee arthroplasty 10.68 10.45 73 189118 7371 34760369
Fibromyalgia 10.68 10.45 39 189152 3061 34764679
Spinal cord paralysis 10.64 10.45 6 189185 68 34767672
Visual acuity reduced 10.64 10.45 48 189143 16101 34751639
Hepatitis B 10.63 10.45 10 189181 5973 34761767
Blood calcium decreased 10.62 10.45 92 189099 9992 34757748
Infantile fibromatosis 10.61 10.45 3 189188 3 34767737
Shoplifting 10.61 10.45 3 189188 3 34767737
Infective glossitis 10.61 10.45 3 189188 3 34767737
Brain natriuretic peptide increased 10.61 10.45 9 189182 5650 34762090
Upper respiratory tract infection 10.60 10.45 121 189070 32938 34734802
Small for dates baby 10.57 10.45 4 189187 3923 34763817
Arthrofibrosis 10.57 10.45 6 189185 69 34767671
Cardiotoxicity 10.56 10.45 9 189182 5639 34762101
Chemical burns of eye 10.55 10.45 4 189187 16 34767724
PCO2 increased 10.52 10.45 15 189176 621 34767119
Subdural haematoma 10.50 10.45 66 189125 20355 34747385
Pulmonary function test decreased 10.50 10.45 7 189184 4968 34762772
Panniculitis 10.46 10.45 29 189162 1965 34765775

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 3695.11 9.78 4318 397091 158373 79184606
Completed suicide 2415.89 9.78 4387 397022 241380 79101599
Respiratory arrest 1900.80 9.78 1865 399544 55685 79287294
Toxicity to various agents 1687.09 9.78 5301 396108 416239 78926740
Drug abuser 1510.70 9.78 694 400715 5319 79337660
Drug dependence 1273.42 9.78 1282 400127 39487 79303492
Overdose 1146.03 9.78 2727 398682 181479 79161500
Accidental overdose 1008.88 9.78 1117 400292 38464 79304515
Drug withdrawal syndrome 940.98 9.78 1012 400397 33706 79309273
Cardio-respiratory arrest 825.19 9.78 1741 399668 106769 79236210
Cardiac arrest 710.52 9.78 2191 399218 169905 79173074
Off label use 662.24 9.78 2349 399060 904866 78438113
Substance abuse 626.62 9.78 478 400931 10048 79332931
Inadequate analgesia 584.08 9.78 336 401073 4293 79338686
Muscle injury 567.09 9.78 937 400472 47624 79295355
Irritable bowel syndrome 544.77 9.78 1059 400350 61182 79281797
Folliculitis 530.16 9.78 979 400430 54401 79288578
Sleep disorder due to general medical condition, insomnia type 476.09 9.78 816 400593 42740 79300239
Poisoning 459.69 9.78 601 400808 24671 79318308
Death 442.07 9.78 4573 396836 561941 78781038
Respiratory depression 410.63 9.78 596 400813 27034 79315945
Confusional state 403.16 9.78 2861 398548 315136 79027843
Impaired healing 388.72 9.78 1145 400264 86510 79256469
Intentional product misuse 388.11 9.78 1207 400202 93958 79249021
Delirium 357.80 9.78 1087 400322 83540 79259439
Stomatitis 338.22 9.78 1550 399859 145207 79197772
Miosis 324.39 9.78 399 401010 15390 79327589
Lower respiratory tract infection 297.88 9.78 1365 400044 127855 79215124
Drug screen positive 285.52 9.78 240 401169 5823 79337156
Accidental death 262.33 9.78 198 401211 4093 79338886
Helicobacter infection 254.17 9.78 851 400558 68853 79274126
Duodenal ulcer perforation 250.93 9.78 819 400590 65392 79277587
Blister 249.10 9.78 1226 400183 118250 79224729
Somnolence 233.40 9.78 2025 399384 236956 79106023
Ill-defined disorder 231.16 9.78 794 400615 65081 79277898
Malignant neoplasm progression 220.09 9.78 1302 400107 134688 79208291
Drug ineffective 216.38 9.78 3989 397420 1076924 78266055
Product use in unapproved indication 215.50 9.78 600 400809 249759 79093220
Cough 209.62 9.78 1041 400368 365748 78977231
Unresponsive to stimuli 203.28 9.78 681 400728 55107 79287872
Constipation 198.21 9.78 2238 399171 280812 79062167
Mental status changes 186.34 9.78 749 400660 66210 79276769
Gastrointestinal disorder 181.27 9.78 1144 400265 121061 79221918
Condition aggravated 180.85 9.78 1632 399777 499492 78843487
COVID-19 178.78 9.78 325 401084 157349 79185630
Hyperaesthesia 169.15 9.78 255 401154 11967 79331012
Drug tolerance 166.66 9.78 212 401197 8463 79334516
Exposure via ingestion 165.68 9.78 165 401244 5009 79337970
Plasma cell myeloma 165.54 9.78 617 400792 52642 79290337
Injection site pain 157.82 9.78 256 401153 129582 79213397
Gun shot wound 145.14 9.78 84 401325 1086 79341893
Toxic leukoencephalopathy 140.90 9.78 82 401327 1072 79341907
Therapeutic product effect decreased 132.48 9.78 1334 400075 162529 79180450
Coma 130.96 9.78 912 400497 99737 79243242
Respiratory rate decreased 130.15 9.78 146 401263 5097 79337882
Drug resistance 129.83 9.78 27 401382 42186 79300793
Cytomegalovirus infection 127.65 9.78 29 401380 42615 79300364
Cardiac failure 123.78 9.78 384 401025 154458 79188521
Product dose omission issue 117.14 9.78 747 400662 246790 79096189
Angioedema 114.62 9.78 128 401281 75907 79267072
Night sweats 114.57 9.78 543 400866 51552 79291427
Depressed level of consciousness 114.33 9.78 856 400553 95796 79247183
Sinusitis 113.73 9.78 1493 399916 194008 79148971
Injection site erythema 112.11 9.78 137 401272 78060 79264919
Drug reaction with eosinophilia and systemic symptoms 106.08 9.78 100 401309 64144 79278835
Medication error 105.75 9.78 649 400760 67993 79274986
Pericarditis 105.67 9.78 891 400518 103345 79239634
Drug interaction 105.65 9.78 1463 399946 413720 78929259
Narcotic bowel syndrome 105.39 9.78 43 401366 237 79342742
Device expulsion 102.73 9.78 7 401402 25854 79317125
Peripheral swelling 100.55 9.78 1911 399498 267706 79075273
Anti-cyclic citrullinated peptide antibody positive 99.83 9.78 739 400670 82404 79260575
Malaise 97.66 9.78 1807 399602 488062 78854917
Exposure during pregnancy 96.43 9.78 230 401179 100902 79242077
Injection site swelling 93.44 9.78 61 401348 47071 79295908
Lactic acidosis 92.94 9.78 131 401278 70228 79272751
Glossodynia 92.20 9.78 859 400550 102478 79240501
Injection site reaction 91.96 9.78 84 401325 54701 79288278
Muscle spasticity 90.84 9.78 276 401133 21199 79321780
Sopor 88.33 9.78 28 401381 32982 79309997
Enthesopathy 87.82 9.78 186 401223 11422 79331557
Withdrawal syndrome 87.55 9.78 316 401093 26538 79316441
Therapeutic product effect incomplete 87.23 9.78 391 401018 141254 79201725
Toxicologic test abnormal 85.91 9.78 64 401345 1296 79341683
Psoriasis 85.21 9.78 204 401205 89383 79253596
Atrial fibrillation 82.32 9.78 620 400789 197266 79145713
Myelosuppression 81.46 9.78 51 401358 40245 79302734
Nasal congestion 80.45 9.78 165 401244 76387 79266592
Tenosynovitis 79.50 9.78 214 401195 15340 79327639
Bradypnoea 79.14 9.78 123 401286 5929 79337050
Synovitis 79.00 9.78 1130 400279 149604 79193375
Lethargy 78.77 9.78 688 400721 80604 79262375
Pemphigus 78.19 9.78 806 400603 98776 79244203
C-reactive protein abnormal 78.12 9.78 463 400946 47904 79295075
Drug use disorder 77.85 9.78 149 401260 8502 79334477
Arthropathy 76.86 9.78 1286 400123 175825 79167154
Deafness neurosensory 76.35 9.78 130 401279 6768 79336211
Discomfort 76.25 9.78 967 400442 124650 79218329
Sickle cell anaemia with crisis 75.71 9.78 140 401269 7782 79335197
Hand deformity 74.55 9.78 826 400583 103093 79239886
Abortion spontaneous 73.83 9.78 28 401381 29479 79313500
Tongue disorder 73.17 9.78 194 401215 13781 79329198
Product use issue 73.03 9.78 689 400720 209133 79133846
Deep vein thrombosis 71.34 9.78 926 400483 119993 79222986
Systemic lupus erythematosus 71.16 9.78 927 400482 120222 79222757
Infection 71.11 9.78 1655 399754 240057 79102922
Palpitations 70.66 9.78 362 401047 126248 79216731
Contusion 70.43 9.78 1096 400313 147680 79195299
Cataract 68.64 9.78 130 401279 61990 79280989
Cardiogenic shock 68.31 9.78 66 401343 41848 79301131
Syncope 68.26 9.78 576 400833 178873 79164106
Dizziness 67.37 9.78 2077 399332 524364 78818615
Toxic epidermal necrolysis 67.24 9.78 75 401334 44506 79298473
Oropharyngeal pain 66.63 9.78 303 401106 109050 79233929
Blood pressure increased 66.51 9.78 711 400698 210649 79132330
Road traffic accident 64.22 9.78 408 401001 43256 79299723
Swelling 63.79 9.78 1484 399925 215227 79127752
Neutropenia 63.74 9.78 1041 400368 286669 79056310
Wound 63.30 9.78 877 400532 115302 79227677
Incorrect route of product administration 62.74 9.78 344 401065 34585 79308394
Cardiac failure congestive 62.66 9.78 439 400970 141963 79201016
Poisoning deliberate 62.61 9.78 223 401186 18605 79324374
Presbyacusis 62.51 9.78 72 401337 2588 79340391
Acute kidney injury 62.42 9.78 2066 399343 517338 78825641
Influenza 61.83 9.78 390 401019 129216 79213763
Productive cough 61.77 9.78 232 401177 88099 79254880
Asthma 61.66 9.78 412 400997 134683 79208296
Epilepsy 61.34 9.78 69 401340 40791 79302188
Headache 60.43 9.78 2683 398726 651089 78691890
Body temperature increased 59.82 9.78 406 401003 44014 79298965
Serotonin syndrome 59.72 9.78 410 400999 44617 79298362
Nasal necrosis 59.62 9.78 24 401385 127 79342852
Cancer pain 59.58 9.78 100 401309 5145 79337834
Drug ineffective for unapproved indication 58.59 9.78 105 401304 51133 79291846
Accidental exposure to product by child 58.58 9.78 73 401336 2853 79340126
Hypoglycaemia 58.09 9.78 288 401121 101306 79241673
Ear pain 57.89 9.78 322 401087 32547 79310432
Inappropriate schedule of product administration 57.79 9.78 414 400995 133214 79209765
Pulmonary embolism 57.01 9.78 1196 400213 170458 79172521
Melaena 56.84 9.78 140 401269 60750 79282229
Drug tolerance increased 56.70 9.78 37 401372 600 79342379
Injection site pruritus 56.56 9.78 78 401331 42205 79300774
Pleural fibrosis 56.33 9.78 86 401323 4081 79338898
Paroxysmal sympathetic hyperactivity 55.44 9.78 16 401393 21 79342958
Back pain 55.11 9.78 1959 399450 302221 79040758
Rhinorrhoea 55.04 9.78 197 401212 75877 79267102
Myalgia 55.02 9.78 633 400776 185008 79157971
Transplant rejection 54.72 9.78 15 401394 19422 79323557
Delusional disorder, unspecified type 54.38 9.78 39 401370 743 79342236
Aspergillus infection 53.54 9.78 15 401394 19146 79323833
Product complaint 53.16 9.78 168 401241 13181 79329798
Hypertension 52.63 9.78 1266 400143 329726 79013253
Compartment syndrome 52.63 9.78 93 401316 4989 79337990
Terminal state 52.62 9.78 91 401318 4798 79338181
Haematotoxicity 51.89 9.78 8 401401 15511 79327468
Haematochezia 50.95 9.78 247 401162 87398 79255581
Eosinophilia 50.88 9.78 94 401315 45251 79297728
Chest discomfort 50.75 9.78 447 400962 137597 79205382
Renal impairment 50.34 9.78 529 400880 157254 79185725
Apparent death 50.34 9.78 67 401342 2798 79340181
Cholecystitis chronic 50.33 9.78 136 401273 9770 79333209
Blood magnesium increased 49.73 9.78 74 401335 3432 79339547
Anaphylactic reaction 48.68 9.78 236 401173 83507 79259472
Aplastic anaemia 48.24 9.78 15 401394 17890 79325089
Red blood cell sedimentation rate 47.82 9.78 94 401315 5471 79337508
Hepatitis 47.54 9.78 134 401275 55593 79287386
Alanine aminotransferase abnormal 47.34 9.78 124 401285 8743 79334236
Seizure 47.01 9.78 668 400741 188166 79154813
Weight increased 46.96 9.78 1773 399636 275613 79067366
Alcohol use 46.95 9.78 86 401323 4745 79338234
Pleural thickening 46.75 9.78 66 401343 2916 79340063
Vomiting 46.25 9.78 3921 397488 661907 78681072
Cerebral haemorrhage 46.08 9.78 143 401266 57530 79285449
Stress 45.33 9.78 226 401183 79386 79263593
Bronchitis 45.00 9.78 430 400979 130214 79212765
Facet joint syndrome 44.79 9.78 142 401267 11160 79331819
Injury 44.66 9.78 591 400818 76905 79266074
Dependence 44.66 9.78 58 401351 2364 79340615
Joint swelling 44.42 9.78 1826 399583 286820 79056159
Deep vein thrombosis postoperative 44.37 9.78 137 401272 10615 79332364
Hypercalcaemia 44.09 9.78 338 401071 38092 79304887
COVID-19 pneumonia 44.09 9.78 48 401361 28801 79314178
Angina pectoris 43.69 9.78 125 401284 51607 79291372
Proteinuria 43.43 9.78 60 401349 32442 79310537
Injection site bruising 43.39 9.78 88 401321 40914 79302065
Circulatory collapse 43.24 9.78 77 401332 37591 79305388
Premature delivery 43.05 9.78 33 401376 23434 79319545
Post transplant lymphoproliferative disorder 43.03 9.78 4 401405 11460 79331519
Epistaxis 42.81 9.78 357 401052 111158 79231821
Blood pressure fluctuation 42.74 9.78 183 401226 66962 79276017
Multiple organ dysfunction syndrome 42.18 9.78 394 401015 119852 79223127
No adverse event 41.82 9.78 77 401332 37115 79305864
Salpingo-oophorectomy unilateral 41.32 9.78 34 401375 800 79342179
Bradycardia 41.03 9.78 460 400949 135097 79207882
Depression 40.93 9.78 1403 400006 215387 79127592
Epstein-Barr virus infection 40.82 9.78 11 401398 14405 79328574
Pathogen resistance 40.50 9.78 11 401398 14331 79328648
Drug-induced liver injury 40.39 9.78 183 401226 65934 79277045
Drug diversion 40.28 9.78 40 401369 1210 79341769
Sleep disorder due to a general medical condition 40.23 9.78 11 401398 14266 79328713
Creatinine renal clearance decreased 39.88 9.78 23 401386 18979 79324000
Septic shock 39.87 9.78 410 400999 122391 79220588
Hyponatraemia 39.85 9.78 642 400767 177206 79165773
Maternal exposure timing unspecified 39.48 9.78 89 401320 5703 79337276
Osteosclerosis 38.99 9.78 71 401338 3900 79339079
Oesophageal motility disorder 38.75 9.78 28 401381 540 79342439
Viral infection 38.52 9.78 101 401308 42915 79300064
Rheumatoid arthritis 38.31 9.78 1345 400064 207125 79135854
Vertigo 38.26 9.78 198 401211 68884 79274095
Foreign body reaction 37.99 9.78 18 401391 149 79342830
Lip dry 37.83 9.78 166 401243 15252 79327727
Leukopenia 37.83 9.78 389 401020 116124 79226855
Acute lung injury 37.77 9.78 61 401348 3039 79339940
Eye pruritus 37.64 9.78 29 401380 20541 79322438
Apnoea 37.54 9.78 137 401272 11567 79331412
Non-small cell lung cancer 37.14 9.78 92 401317 6268 79336711
Brain injury 37.10 9.78 135 401274 11382 79331597
Emotional distress 37.02 9.78 335 401074 39634 79303345
Spinal cord ischaemia 37.00 9.78 18 401391 159 79342820
Myoclonus 36.76 9.78 252 401157 27408 79315571
Neuroleptic malignant syndrome 36.70 9.78 51 401358 27508 79315471
Immune reconstitution inflammatory syndrome 36.57 9.78 12 401397 13829 79329150
Hepatotoxicity 36.47 9.78 134 401275 51218 79291761
Ear infection 36.35 9.78 74 401335 34358 79308621
Diabetes mellitus 36.29 9.78 238 401171 78152 79264827
Respiratory tract infection 35.94 9.78 125 401284 48564 79294415
Agitation 35.82 9.78 703 400706 99012 79243967
Agranulocytosis 35.73 9.78 112 401297 44918 79298061
Sedation 35.62 9.78 409 401000 51486 79291493
Pupillary reflex impaired 35.55 9.78 62 401347 3291 79339688
Bladder cancer 35.14 9.78 28 401381 19498 79323481
Anaphylactic shock 34.99 9.78 81 401328 35915 79307064
Upper respiratory tract infection 34.93 9.78 292 401117 90876 79252103
Device difficult to use 34.68 9.78 12 401397 13373 79329606
Extrapyramidal disorder 34.37 9.78 38 401371 22641 79320338
Underdose 34.36 9.78 72 401337 33079 79309900
Victim of homicide 33.93 9.78 17 401392 161 79342818
Respiratory disorder 33.75 9.78 360 401049 44496 79298483
Insomnia 33.69 9.78 1533 399876 243637 79099342
Velopharyngeal incompetence 33.53 9.78 9 401400 7 79342972
Device issue 33.34 9.78 53 401356 27055 79315924
Feeling hot 33.19 9.78 171 401238 59563 79283416
Acute myocardial infarction 33.14 9.78 239 401170 76797 79266182
Hepatic enzyme increased 32.77 9.78 1175 400234 181435 79161544
Contraindicated product administered 32.67 9.78 1031 400378 156507 79186472
Haemorrhage 32.19 9.78 298 401111 90820 79252159
Amnestic disorder 32.09 9.78 26 401383 598 79342381
Swelling face 32.07 9.78 218 401191 70994 79271985
Orthostatic hypotension 31.08 9.78 161 401248 56003 79286976
Throat irritation 30.99 9.78 104 401305 40842 79302137
Soft tissue disorder 30.97 9.78 60 401349 3455 79339524
Therapeutic response shortened 30.81 9.78 21 401388 15842 79327137
Inflammatory marker increased 30.78 9.78 8 401401 10732 79332247
Breakthrough pain 30.62 9.78 36 401373 1323 79341656
Substance dependence 30.24 9.78 23 401386 481 79342498
Lip swelling 30.22 9.78 105 401304 40806 79302173
Blood parathyroid hormone decreased 30.21 9.78 119 401290 10417 79332562
Granulocytopenia 30.04 9.78 10 401399 11421 79331558
Pulmonary arterial hypertension 29.92 9.78 61 401348 28305 79314674
Status epilepticus 29.82 9.78 50 401359 24991 79317988
Anoxia 29.79 9.78 20 401389 341 79342638
Myelodysplastic syndrome 29.60 9.78 68 401341 30233 79312746
Erythema 29.45 9.78 877 400532 222413 79120566
Failure to thrive 29.42 9.78 128 401281 11716 79331263
Dyspnoea exertional 29.38 9.78 288 401121 86785 79256194
Injection site mass 29.31 9.78 35 401374 20149 79322830
Post laminectomy syndrome 29.18 9.78 19 401390 307 79342672
Small intestinal obstruction 29.16 9.78 236 401173 27036 79315943
Granuloma skin 29.10 9.78 107 401302 9067 79333912
Cardiac failure chronic 28.82 9.78 10 401399 11125 79331854
Progressive multifocal leukoencephalopathy 28.57 9.78 37 401372 20563 79322416
Colitis ulcerative 28.57 9.78 85 401324 34657 79308322
Full blood count abnormal 28.49 9.78 106 401303 40368 79302611
BK virus infection 28.41 9.78 5 401404 8799 79334180
Cardiac failure acute 28.37 9.78 32 401377 18897 79324082
Injection site warmth 28.23 9.78 20 401389 14787 79328192
Sinus tachycardia 28.14 9.78 297 401112 36611 79306368
Hypertensive crisis 28.10 9.78 38 401371 20732 79322247
Intraocular pressure increased 28.07 9.78 6 401403 9199 79333780
Decreased appetite 28.04 9.78 2043 399366 340375 79002604
Cytomegalovirus infection reactivation 28.02 9.78 5 401404 8711 79334268
Faecaloma 27.99 9.78 124 401285 11440 79331539
Nasopharyngitis 27.97 9.78 1554 399855 252327 79090652
Accidental poisoning 27.97 9.78 38 401371 1619 79341360
Drug detoxification 27.80 9.78 20 401389 383 79342596
Self-medication 27.64 9.78 72 401337 5060 79337919
Intestinal sepsis 27.56 9.78 28 401381 871 79342108
Pemphigoid 27.51 9.78 22 401387 15293 79327686
Myasthenia gravis 27.50 9.78 9 401400 10390 79332589
Drug screen negative 27.47 9.78 18 401391 294 79342685
Fluid retention 27.47 9.78 222 401187 69587 79273392
Flushing 27.31 9.78 298 401111 87970 79255009
Subarachnoid haemorrhage 27.20 9.78 51 401358 24414 79318565
Parkinsonism 27.15 9.78 26 401383 16558 79326421
Mucormycosis 26.92 9.78 5 401404 8464 79334515
Cardiotoxicity 26.87 9.78 14 401395 12225 79330754
Caesarean section 26.55 9.78 15 401394 12520 79330459
Acute graft versus host disease 26.54 9.78 9 401400 10158 79332821
Hypoxia 26.46 9.78 694 400715 102549 79240430
Leukoencephalopathy 26.44 9.78 94 401315 7835 79335144
Device dislocation 26.42 9.78 57 401352 25913 79317066
Arrhythmia 26.40 9.78 190 401219 61082 79281897
Immunodeficiency 26.36 9.78 43 401366 21725 79321254
Neutrophil count increased 26.34 9.78 69 401340 29327 79313652
Piloerection 26.00 9.78 21 401388 481 79342498
Panniculitis 25.79 9.78 127 401282 12244 79330735
Paradoxical drug reaction 25.70 9.78 3 401406 7182 79335797
Ventricular fibrillation 25.61 9.78 79 401330 31847 79311132
Eosinophil count increased 25.55 9.78 29 401380 17076 79325903
Glomerular filtration rate decreased 25.52 9.78 47 401362 22655 79320324
Schizophrenia 25.52 9.78 24 401385 15416 79327563
Ileus 25.47 9.78 222 401187 25989 79316990
Anaemia 25.43 9.78 1912 399497 443103 78899876
Tendonitis 25.36 9.78 206 401203 23624 79319355
Hypogammaglobulinaemia 25.34 9.78 17 401392 12934 79330045
Sinusitis fungal 25.30 9.78 44 401365 2330 79340649
Fibromyalgia 25.30 9.78 460 400949 63880 79279099
Injection site haemorrhage 25.29 9.78 65 401344 27805 79315174
Secretion discharge 25.25 9.78 23 401386 14999 79327980
Paraesthesia oral 25.20 9.78 40 401369 20431 79322548
Treatment failure 25.19 9.78 659 400750 169827 79173152
Acute chest syndrome 25.14 9.78 35 401374 1526 79341453
Allodynia 25.14 9.78 36 401373 1612 79341367
Opiates positive 24.99 9.78 28 401381 976 79342003
Pneumocystis jirovecii pneumonia 24.99 9.78 82 401327 32426 79310553
Joint stiffness 24.94 9.78 113 401296 40717 79302262
Diabetic ketoacidosis 24.92 9.78 88 401321 34034 79308945
Glaucoma 24.91 9.78 38 401371 19723 79323256
Autoimmune disorder 24.90 9.78 156 401253 16456 79326523
Systemic infection 24.82 9.78 9 401400 9743 79333236
Haemophagocytic lymphohistiocytosis 24.74 9.78 45 401364 21792 79321187
Pallor 24.72 9.78 149 401260 49913 79293066
Gastrointestinal haemorrhage 24.56 9.78 561 400848 147158 79195821
Ventricular tachycardia 24.47 9.78 118 401291 41817 79301162
Hypoventilation 24.39 9.78 86 401323 7138 79335841
Therapy partial responder 24.38 9.78 31 401378 17366 79325613
Cerebrovascular accident 24.36 9.78 595 400814 154697 79188282
Pulmonary tuberculosis 24.25 9.78 5 401404 7860 79335119
Generalised tonic-clonic seizure 24.23 9.78 126 401283 43784 79299195
Epigastric discomfort 24.13 9.78 91 401318 7805 79335174
Dehydration 24.07 9.78 1502 399907 246685 79096294
Forced expiratory volume decreased 24.02 9.78 5 401404 7809 79335170
Product formulation issue 24.01 9.78 27 401382 945 79342034
Pain 23.99 9.78 3961 397448 699841 78643138
Breast cancer female 23.87 9.78 14 401395 11447 79331532
Rales 23.76 9.78 40 401369 19961 79323018
Ulcer 23.71 9.78 243 401166 29729 79313250
Tooth loss 23.70 9.78 84 401325 6991 79335988
Jaundice 23.68 9.78 164 401245 53185 79289794
Pneumonia aspiration 23.67 9.78 471 400938 66496 79276483
Foreign body embolism 23.52 9.78 7 401402 11 79342968
Anxiety 23.37 9.78 1500 399909 247012 79095967
Emphysema 23.16 9.78 151 401258 16149 79326830
Rash erythematous 23.06 9.78 183 401226 57586 79285393
Bronchiectasis 22.88 9.78 49 401360 22337 79320642
Atrioventricular block complete 22.86 9.78 30 401379 16580 79326399
Bronchospasm 22.54 9.78 58 401351 24801 79318178
Mouth ulceration 22.43 9.78 108 401301 38286 79304693
Peripheral venous disease 22.37 9.78 147 401262 15762 79327217
Lupus-like syndrome 22.37 9.78 22 401387 13835 79329144
Arteriosclerosis coronary artery 22.31 9.78 160 401249 17656 79325323
Balance disorder 22.08 9.78 357 401052 98500 79244479
Coeliac disease 22.08 9.78 15 401394 11336 79331643
Malignant melanoma 22.01 9.78 25 401384 14716 79328263
Sneezing 21.91 9.78 41 401368 19642 79323337
Myopathy 21.87 9.78 44 401365 20519 79322460
Bone erosion 21.85 9.78 35 401374 17812 79325167
Cervix neoplasm 21.69 9.78 13 401396 180 79342799
Nausea 21.63 9.78 5279 396130 951917 78391062
Intentional overdose 21.58 9.78 692 400717 105268 79237711
Chronic graft versus host disease 21.56 9.78 4 401405 6777 79336202
Rash papular 21.56 9.78 49 401360 21867 79321112
Transaminases increased 21.55 9.78 162 401247 51581 79291398
Lumbosacral plexopathy 21.48 9.78 5 401404 0 79342979
Chronic kidney disease 21.41 9.78 221 401188 65933 79277046
Tuberculosis 21.39 9.78 27 401382 15171 79327808
Aspiration 21.31 9.78 174 401235 19984 79322995
Cognitive disorder 21.26 9.78 237 401172 69689 79273290
Pupil fixed 21.26 9.78 52 401357 3514 79339465
Tumour pain 21.18 9.78 40 401369 2259 79340720
Concomitant disease aggravated 21.15 9.78 21 401388 13146 79329833
Intestinal pseudo-obstruction 21.14 9.78 43 401366 2566 79340413
Injection site urticaria 21.13 9.78 20 401389 12806 79330173
Lung cancer metastatic 21.06 9.78 53 401356 3646 79339333
Device malfunction 21.06 9.78 48 401361 21400 79321579
Premature labour 20.92 9.78 8 401401 8382 79334597
Pulmonary granuloma 20.92 9.78 38 401371 2083 79340896
Hypomania 20.91 9.78 6 401403 7538 79335441
Disease recurrence 20.88 9.78 133 401276 43976 79299003
Osteoporosis 20.87 9.78 173 401236 53939 79289040
Pancreatitis acute 20.80 9.78 155 401254 49449 79293530
Thermophobia 20.77 9.78 9 401400 59 79342920
Myocardial infarction 20.74 9.78 738 400671 183391 79159588
Blood uric acid increased 20.67 9.78 22 401387 13338 79329641
Haematuria 20.66 9.78 234 401175 68602 79274377
Hysterectomy 20.61 9.78 74 401335 6198 79336781
Metastatic renal cell carcinoma 20.50 9.78 40 401369 2315 79340664
Aspartate aminotransferase increased 20.37 9.78 873 400536 137768 79205211
Swollen tongue 20.34 9.78 128 401281 42442 79300537
Hypophagia 20.24 9.78 331 401078 45036 79297943
Aplasia pure red cell 20.24 9.78 7 401402 7803 79335176
Urinary tract infection 20.15 9.78 1153 400256 273359 79069620
Cystitis 20.15 9.78 169 401240 52563 79290416
C-reactive protein increased 20.06 9.78 495 400914 128532 79214447
Cardiomegaly 20.06 9.78 212 401197 26140 79316839
Spinal operation 20.00 9.78 86 401323 7831 79335148
Wrong technique in product usage process 19.93 9.78 257 401152 73618 79269361
Respiratory acidosis 19.91 9.78 110 401299 11090 79331889
Pruritus 19.83 9.78 2273 399136 392375 78950604
Purpura 19.75 9.78 43 401366 19484 79323495
Lower limb fracture 19.71 9.78 191 401218 23024 79319955
Abdominal discomfort 19.67 9.78 1491 399918 249236 79093743
Complication of device insertion 19.65 9.78 4 401405 6346 79336633
Impaired reasoning 19.49 9.78 10 401399 100 79342879
Hypothalamic pituitary adrenal axis suppression 19.47 9.78 15 401394 320 79342659
Hypotension 19.46 9.78 1930 399479 438387 78904592
Blood pH decreased 19.41 9.78 60 401349 4651 79338328
Accident 19.37 9.78 92 401317 8739 79334240
Dermatitis bullous 19.33 9.78 26 401383 14219 79328760
Oral herpes 19.26 9.78 72 401337 27382 79315597
Hyperthyroidism 19.24 9.78 53 401356 22156 79320823
Spinal fracture 19.18 9.78 156 401253 17898 79325081
Sinus disorder 19.17 9.78 54 401355 22410 79320569
Neutrophilia 19.14 9.78 8 401401 7943 79335036
Injection site induration 19.07 9.78 13 401396 9806 79333173
Heart rate irregular 19.04 9.78 92 401317 32587 79310392
Drug specific antibody present 18.98 9.78 5 401404 6647 79336332
Upper gastrointestinal haemorrhage 18.97 9.78 126 401283 41254 79301725
Red blood cell sedimentation rate abnormal 18.94 9.78 49 401360 20914 79322065
Mobility decreased 18.92 9.78 469 400940 121706 79221273
Cytomegalovirus viraemia 18.86 9.78 22 401387 12799 79330180
Presyncope 18.82 9.78 125 401284 40929 79302050
Blood pressure decreased 18.79 9.78 370 401039 99096 79243883
Congenital central hypoventilation syndrome 18.76 9.78 7 401402 29 79342950
Illness 18.72 9.78 147 401262 46364 79296615
Partial seizures 18.65 9.78 11 401398 8967 79334012
Renal cell carcinoma 18.62 9.78 74 401335 6504 79336475
Aplasia 18.62 9.78 8 401401 7812 79335167
Needle issue 18.61 9.78 23 401386 13045 79329934
Abdominal distension 18.61 9.78 459 400950 119191 79223788
Lymphoproliferative disorder 18.54 9.78 3 401406 5612 79337367
Hallucination 18.52 9.78 564 400845 85181 79257798
Blood glucose increased 18.45 9.78 439 400970 114536 79228443
Cyst 18.33 9.78 126 401283 13714 79329265
Nephrosclerosis 18.32 9.78 33 401376 1797 79341182
Multiple sclerosis relapse 18.30 9.78 148 401261 46385 79296594
Glycosylated haemoglobin increased 18.19 9.78 44 401365 19216 79323763
Macular degeneration 18.16 9.78 18 401391 11278 79331701
Thrombosis 18.12 9.78 553 400856 83547 79259432
Cerebral infarction 18.08 9.78 145 401264 45531 79297448
Thrombocytopenia 18.07 9.78 1122 400287 264137 79078842
Dyspepsia 17.99 9.78 413 400996 108274 79234705
Cytomegalovirus chorioretinitis 17.97 9.78 3 401406 5487 79337492
Injection site rash 17.78 9.78 40 401369 17914 79325065
Complications of transplanted kidney 17.76 9.78 5 401404 6361 79336618
Cardiac disorder 17.65 9.78 229 401180 65528 79277451
Secondary amyloidosis 17.60 9.78 12 401397 210 79342769
Hypersensitivity 17.60 9.78 1541 399868 260698 79082281
Drug level below therapeutic 17.59 9.78 14 401395 9756 79333223
Gait disturbance 17.59 9.78 859 400550 206647 79136332
Disease progression 17.55 9.78 1114 400295 183248 79159731
Gestational diabetes 17.45 9.78 5 401404 6288 79336691
Human herpesvirus 6 infection 17.44 9.78 3 401406 5367 79337612
Acute hepatic failure 17.42 9.78 85 401324 30028 79312951
Heart rate decreased 17.39 9.78 249 401160 70067 79272912
Smear cervix abnormal 17.32 9.78 39 401370 2497 79340482
Sputum discoloured 17.30 9.78 54 401355 21689 79321290
Bronchopulmonary aspergillosis 17.30 9.78 56 401353 22238 79320741
Product counterfeit 17.29 9.78 13 401396 267 79342712
Bone marrow failure 17.26 9.78 169 401240 50938 79292041
Ischaemic stroke 17.21 9.78 97 401312 33034 79309945
Hyperhidrosis 17.20 9.78 930 400479 150562 79192417
Polyneuropathy 17.16 9.78 63 401346 24088 79318891
Sedation complication 17.12 9.78 33 401376 15636 79327343
Stevens-Johnson syndrome 17.09 9.78 121 401288 39045 79303934
Environmental exposure 17.07 9.78 15 401394 387 79342592
Exposure via breast milk 17.05 9.78 23 401386 973 79342006
Compression fracture 16.96 9.78 71 401338 6389 79336590
Eczema 16.90 9.78 128 401281 40690 79302289
Decreased gait velocity 16.88 9.78 11 401398 178 79342801
Snake bite 16.86 9.78 6 401403 21 79342958
Faecalith 16.86 9.78 6 401403 21 79342958
Vasculitis 16.86 9.78 67 401342 25035 79317944
Gallbladder disorder 16.85 9.78 160 401249 19180 79323799
Pulmonary thrombosis 16.84 9.78 112 401297 12059 79330920
Polyarthritis 16.84 9.78 22 401387 12180 79330799
Torsade de pointes 16.80 9.78 46 401363 19266 79323713
Wheezing 16.69 9.78 453 400956 116211 79226768
Adenovirus infection 16.65 9.78 11 401398 8436 79334543
Visual acuity reduced 16.57 9.78 84 401325 29385 79313594
Hypertriglyceridaemia 16.54 9.78 24 401385 12716 79330263
Musculoskeletal stiffness 16.54 9.78 716 400693 174292 79168687
Foetal death 16.51 9.78 10 401399 8034 79334945
Periorbital oedema 16.48 9.78 11 401398 8391 79334588
Catatonia 16.46 9.78 12 401397 8744 79334235
Hemiparesis 16.34 9.78 101 401308 33632 79309347
Bone cyst 16.32 9.78 46 401363 3387 79339592
Blood test abnormal 16.30 9.78 41 401368 17669 79325310
Euglycaemic diabetic ketoacidosis 16.30 9.78 7 401402 6837 79336142
Injection site discolouration 16.29 9.78 9 401400 7605 79335374
Skin ulcer 16.27 9.78 372 401037 53778 79289201
Brain death 16.18 9.78 64 401345 5613 79337366
Hyperkalaemia 16.16 9.78 445 400964 113953 79229026
Cerebral haematoma 16.12 9.78 10 401399 7932 79335047
Sphincter of Oddi dysfunction 16.11 9.78 15 401394 418 79342561
Arthrofibrosis 16.06 9.78 9 401400 109 79342870
Nephropathy toxic 16.05 9.78 51 401358 20368 79322611
Female genital tract fistula 15.95 9.78 66 401343 5909 79337070
Pupillary light reflex tests abnormal 15.94 9.78 13 401396 302 79342677
Euphoric mood 15.88 9.78 79 401330 7647 79335332
Atrioventricular block 15.85 9.78 29 401380 14012 79328967
Encephalopathy 15.83 9.78 448 400961 66949 79276030
Neoplasm progression 15.83 9.78 356 401053 51326 79291653
Learning disability 15.82 9.78 11 401398 199 79342780
Abortion induced 15.80 9.78 8 401401 7101 79335878
Cardiovascular disorder 15.63 9.78 43 401366 17982 79324997
Acne 15.58 9.78 77 401332 27113 79315866
Anosmia 15.52 9.78 13 401396 8831 79334148
Spleen congestion 15.51 9.78 15 401394 439 79342540
Tumour haemorrhage 15.46 9.78 51 401358 4093 79338886
Dyspnoea 15.45 9.78 3956 397453 853069 78489910
Colitis microscopic 15.29 9.78 19 401390 10749 79332230
Rectal haemorrhage 15.28 9.78 281 401128 76019 79266960
Bone pain 15.25 9.78 378 401031 55364 79287615
Gamma-glutamyltransferase increased 15.21 9.78 189 401220 54491 79288488
Drug level decreased 15.16 9.78 31 401378 14371 79328608
Eyelid ptosis 15.15 9.78 20 401389 11024 79331955
Transient ischaemic attack 15.09 9.78 181 401228 52514 79290465
Fear of injection 15.06 9.78 76 401333 7398 79335581
Blood pressure diastolic abnormal 15.06 9.78 48 401361 19154 79323825
Lymphopenia 15.06 9.78 91 401318 30466 79312513
Device breakage 14.98 9.78 19 401390 10656 79332323
Hepatitis B reactivation 14.94 9.78 6 401403 6102 79336877
C-reactive protein 14.90 9.78 57 401352 4922 79338057
Vitamin B12 deficiency 14.86 9.78 9 401400 7232 79335747
Electrocardiogram QT prolonged 14.81 9.78 344 401065 90042 79252937
Subdural haematoma 14.77 9.78 95 401314 31339 79311640
Drug level increased 14.74 9.78 128 401281 39523 79303456
Gonadotrophin deficiency 14.72 9.78 6 401403 33 79342946
Hypoxic-ischaemic encephalopathy 14.71 9.78 78 401331 7742 79335237
Haemodynamic instability 14.67 9.78 42 401367 17340 79325639
Disorientation 14.67 9.78 417 400992 62359 79280620
Vestibular ischaemia 14.63 9.78 5 401404 15 79342964
Mucosal inflammation 14.62 9.78 280 401129 75300 79267679
Impaired driving ability 14.60 9.78 60 401349 5355 79337624
Acidosis 14.58 9.78 158 401251 19604 79323375
Rheumatoid nodule 14.57 9.78 143 401266 17295 79325684
Device leakage 14.54 9.78 20 401389 10836 79332143
Paraesthesia 14.54 9.78 732 400677 175591 79167388
Infusion site pain 14.51 9.78 31 401378 14145 79328834
Venoocclusive liver disease 14.49 9.78 23 401386 11748 79331231
Food allergy 14.44 9.78 20 401389 10804 79332175
Nodule 14.43 9.78 63 401346 22931 79320048
Irritability 14.41 9.78 289 401120 40855 79302124
Oesophageal carcinoma 14.28 9.78 21 401388 11063 79331916
Consciousness fluctuating 14.26 9.78 31 401378 1938 79341041
Joint destruction 14.20 9.78 6 401403 5919 79337060
Postmortem blood drug level abnormal 14.20 9.78 17 401392 637 79342342
Visual impairment 14.17 9.78 354 401055 91777 79251202
Blood immunoglobulin E increased 14.03 9.78 6 401403 5876 79337103
Pathological fracture 14.00 9.78 96 401313 10441 79332538
Atelectasis 13.89 9.78 234 401175 32023 79310956
Lung transplant 13.85 9.78 3 401406 4558 79338421
Product storage error 13.85 9.78 39 401370 16187 79326792
Refusal of treatment by patient 13.83 9.78 85 401324 8906 79334073
Obstructive airways disorder 13.82 9.78 97 401312 31362 79311617
Formication 13.82 9.78 56 401353 4967 79338012
Metabolic encephalopathy 13.78 9.78 86 401323 9061 79333918
Acute graft versus host disease in skin 13.76 9.78 11 401398 7647 79335332
Dermatitis allergic 13.75 9.78 46 401363 18084 79324895
Hepatitis B 13.72 9.78 13 401396 8319 79334660
Blood creatine phosphokinase MB increased 13.69 9.78 38 401371 2773 79340206
Product residue present 13.62 9.78 44 401365 3492 79339487
Aptyalism 13.61 9.78 18 401391 747 79342232
Eye disorder 13.59 9.78 66 401343 23346 79319633
Blood potassium increased 13.58 9.78 215 401194 29060 79313919
Dermatitis exfoliative 13.48 9.78 21 401388 10808 79332171
Visceral oedema 13.46 9.78 8 401401 109 79342870
Aphthous ulcer 13.40 9.78 42 401367 16847 79326132
Pain of skin 13.32 9.78 34 401375 14579 79328400
Pseudomonas infection 13.28 9.78 57 401352 20846 79322133
Labelled drug-drug interaction medication error 13.28 9.78 83 401326 27567 79315412
Paranoia 13.27 9.78 153 401256 19279 79323700
Gingival bleeding 13.25 9.78 40 401369 16236 79326743
Sarcopenia 13.23 9.78 14 401395 457 79342522
Liver function test increased 13.23 9.78 132 401277 39641 79303338
Ketoacidosis 13.23 9.78 12 401397 7842 79335137
Coronary artery bypass 13.21 9.78 7 401402 6055 79336924
Faeces discoloured 13.19 9.78 89 401320 29038 79313941
Diabetes mellitus inadequate control 13.18 9.78 70 401339 24194 79318785
Sputum increased 13.14 9.78 52 401357 4561 79338418
Diarrhoea 13.14 9.78 4097 397312 876392 78466587
Eyelid oedema 13.14 9.78 31 401378 13656 79329323
Eye inflammation 13.12 9.78 8 401401 6405 79336574
Oesophageal achalasia 13.09 9.78 18 401391 776 79342203
Artery dissection 13.08 9.78 11 401398 267 79342712
Loss of consciousness 13.05 9.78 998 400411 166945 79176034
Maternal exposure before pregnancy 13.03 9.78 3 401406 4370 79338609
Mandibular mass 13.03 9.78 10 401399 212 79342767
Breast cancer metastatic 13.03 9.78 81 401328 8521 79334458
Prostate cancer 12.99 9.78 106 401303 33162 79309817
Blood phosphorus increased 12.94 9.78 20 401389 10327 79332652
Pancytopenia 12.92 9.78 692 400717 165053 79177926
Normal newborn 12.90 9.78 10 401399 7062 79335917
Arteriospasm coronary 12.90 9.78 9 401400 6707 79336272
Hormone replacement therapy 12.89 9.78 3 401406 0 79342979
Seasonal allergy 12.88 9.78 41 401368 16365 79326614
Dry mouth 12.87 9.78 554 400855 87465 79255514
Dental restoration failure 12.87 9.78 20 401389 964 79342015
Therapeutic product effect increased 12.85 9.78 26 401383 1545 79341434
Lumbar radiculopathy 12.84 9.78 30 401379 1969 79341010
Therapeutic response decreased 12.83 9.78 248 401161 66605 79276374
Therapy cessation 12.77 9.78 124 401285 37438 79305541
Injection site extravasation 12.77 9.78 18 401391 9651 79333328
Lip oedema 12.76 9.78 8 401401 6308 79336671
Autoimmune haemolytic anaemia 12.74 9.78 14 401395 8366 79334613
Sensitivity to weather change 12.73 9.78 13 401396 8034 79334945
Skin reaction 12.72 9.78 40 401369 16028 79326951
Renal cancer metastatic 12.70 9.78 17 401392 714 79342265
Faecal calprotectin increased 12.67 9.78 6 401403 5535 79337444
Kidney transplant rejection 12.63 9.78 20 401389 10226 79332753
Uveitis 12.56 9.78 43 401366 16787 79326192
Femur fracture 12.56 9.78 129 401280 38523 79304456
Pain in extremity 12.56 9.78 1625 399784 362913 78980066
Muscular weakness 12.54 9.78 671 400738 160058 79182921
SARS-CoV-2 test positive 12.52 9.78 25 401384 11691 79331288
Transfusion 12.46 9.78 60 401349 21270 79321709
Incorrect dose administered 12.45 9.78 292 401117 76338 79266641
Hyperprolactinaemia 12.45 9.78 4 401405 4672 79338307
Shock 12.31 9.78 150 401259 43398 79299581
Transplant failure 12.30 9.78 4 401405 4637 79338342
Cholangitis 12.30 9.78 108 401301 12668 79330311
Defaecation urgency 12.29 9.78 7 401402 5817 79337162
Brain oedema 12.28 9.78 187 401222 25076 79317903
Snoring 12.22 9.78 58 401351 5508 79337471
Protein urine present 12.22 9.78 20 401389 10092 79332887
Skin necrosis 12.16 9.78 142 401267 17945 79325034
Drug intolerance 12.16 9.78 1513 399896 262606 79080373
Nervousness 12.13 9.78 236 401173 33179 79309800
Libido decreased 12.09 9.78 56 401353 5265 79337714
Fall 12.06 9.78 2216 399193 485413 78857566
Iron deficiency 12.03 9.78 22 401387 10632 79332347
Hypomagnesaemia 12.00 9.78 165 401244 46746 79296233
Shock haemorrhagic 11.97 9.78 56 401353 20004 79322975
Troponin T increased 11.95 9.78 42 401367 3480 79339499
Coronary artery disease 11.93 9.78 245 401164 65229 79277750
Paranoid personality disorder 11.91 9.78 5 401404 30 79342949
Second primary malignancy 11.88 9.78 35 401374 14315 79328664
Polymyalgia rheumatica 11.87 9.78 4 401405 4533 79338446
Tongue oedema 11.84 9.78 11 401398 7106 79335873
Pulmonary congestion 11.82 9.78 197 401212 26903 79316076
Gastroenteritis 11.80 9.78 112 401297 33970 79309009
Device use error 11.78 9.78 11 401398 7090 79335889
Central nervous system stimulation 11.78 9.78 6 401403 59 79342920
Pulseless electrical activity 11.77 9.78 116 401293 14044 79328935
Face oedema 11.76 9.78 88 401321 28048 79314931
Blood alkaline phosphatase increased 11.74 9.78 411 400998 63253 79279726
Immunosuppressant drug level increased 11.73 9.78 17 401392 9010 79333969
Signet-ring cell carcinoma 11.70 9.78 4 401405 12 79342967
Foot deformity 11.70 9.78 72 401337 24002 79318977
Thrombotic microangiopathy 11.62 9.78 57 401352 20112 79322867
Bradykinesia 11.62 9.78 14 401395 8029 79334950
Squamous cell carcinoma 11.60 9.78 40 401369 15582 79327397
Treatment noncompliance 11.59 9.78 189 401220 52079 79290900
Skin cancer 11.52 9.78 38 401371 15002 79327977
Laryngeal pain 11.51 9.78 61 401348 6053 79336926
Faeces soft 11.49 9.78 15 401394 8308 79334671
Embolism venous 11.45 9.78 47 401362 4192 79338787
Tachyphylaxis 11.43 9.78 11 401398 320 79342659
Ocular hyperaemia 11.42 9.78 89 401320 28117 79314862
Joint range of motion decreased 11.40 9.78 233 401176 33049 79309930
Syringe issue 11.37 9.78 9 401400 6289 79336690
Symptom masked 11.37 9.78 23 401386 1367 79341612
Rash pustular 11.36 9.78 25 401384 11286 79331693
Conjunctival hyperaemia 11.36 9.78 4 401405 4409 79338570
Mental disorder 11.34 9.78 221 401188 31081 79311898
Hypoaesthesia oral 11.29 9.78 35 401374 14089 79328890
Laryngitis 11.29 9.78 42 401367 15997 79326982
Cutaneous vasculitis 11.26 9.78 15 401394 8237 79334742
Gastrooesophageal reflux disease 11.24 9.78 420 400989 103826 79239153
Hallucination, synaesthetic 11.20 9.78 6 401403 66 79342913
Myelitis transverse 11.19 9.78 28 401381 1919 79341060
Metastases to bone 11.18 9.78 179 401230 24248 79318731
Diarrhoea haemorrhagic 11.16 9.78 32 401377 13202 79329777
Inappropriate antidiuretic hormone secretion 11.14 9.78 82 401327 26231 79316748
Convulsions local 11.13 9.78 6 401403 67 79342912
Victim of crime 11.12 9.78 13 401396 475 79342504
Ovarian cyst 11.11 9.78 30 401379 12625 79330354
N-terminal prohormone brain natriuretic peptide increased 11.11 9.78 5 401404 4750 79338229
Haemolytic anaemia 11.07 9.78 49 401360 17771 79325208
Renal failure 11.05 9.78 866 400543 200102 79142877
Central nervous system injury 11.04 9.78 8 401401 155 79342824
Gastrointestinal procedural complication 11 9.78 9 401400 210 79342769
Left ventricular dysfunction 11.00 9.78 55 401354 19306 79323673
Strongyloidiasis 10.99 9.78 3 401406 3895 79339084
Metastases to spine 10.95 9.78 47 401362 4277 79338702
Conjunctivitis 10.95 9.78 80 401329 25635 79317344
Spinal cord compression 10.91 9.78 62 401347 6315 79336664
Dental caries 10.91 9.78 99 401310 11721 79331258
Acute pulmonary oedema 10.86 9.78 36 401373 14194 79328785
Salivary hypersecretion 10.85 9.78 36 401373 14188 79328791
Cytomegalovirus colitis 10.83 9.78 5 401404 4680 79338299
Non-obstructive cardiomyopathy 10.83 9.78 3 401406 3 79342976
Blood pressure abnormal 10.80 9.78 47 401362 17122 79325857
Clear cell renal cell carcinoma 10.79 9.78 33 401376 2543 79340436
Post procedural pulmonary embolism 10.79 9.78 10 401399 277 79342702
Atrial tachycardia 10.75 9.78 12 401397 7121 79335858
Pulmonary infarction 10.66 9.78 43 401366 3806 79339173
Non-small cell lung cancer metastatic 10.65 9.78 19 401390 1027 79341952
Renal mass 10.63 9.78 39 401370 3301 79339678
Poor venous access 10.63 9.78 51 401358 18098 79324881
Herpes simplex 10.62 9.78 29 401380 12158 79330821
Suicide attempt 10.61 9.78 327 401082 82605 79260374
Multiple allergies 10.61 9.78 23 401386 10437 79332542
Depressive symptom 10.60 9.78 10 401399 6413 79336566
Blood pressure diastolic decreased 10.59 9.78 99 401310 30117 79312862
Skin plaque 10.59 9.78 24 401385 10721 79332258
Hepatocellular injury 10.58 9.78 172 401237 47421 79295558
Carbon dioxide abnormal 10.58 9.78 12 401397 424 79342555
Demyelination 10.53 9.78 15 401394 8008 79334971
Diffuse large B-cell lymphoma recurrent 10.51 9.78 4 401405 4203 79338776
Hypersomnia 10.51 9.78 169 401240 22917 79320062
Joint arthroplasty 10.47 9.78 34 401375 2706 79340273
Yawning 10.46 9.78 22 401387 1344 79341635
Serum serotonin decreased 10.46 9.78 4 401405 18 79342961
Disturbance in social behaviour 10.45 9.78 6 401403 4964 79338015
Pneumonia cytomegaloviral 10.45 9.78 6 401403 4963 79338016
Optic neuritis 10.45 9.78 20 401389 9500 79333479
Failure to anastomose 10.41 9.78 9 401400 227 79342752
Nocardiosis 10.40 9.78 8 401401 5671 79337308
Acute coronary syndrome 10.38 9.78 63 401346 21070 79321909
Application site burn 10.37 9.78 17 401392 858 79342121
Metastatic gastric cancer 10.35 9.78 11 401398 361 79342618
Exposure via inhalation 10.34 9.78 7 401402 121 79342858
Hallucination, tactile 10.33 9.78 14 401395 595 79342384
Cystitis haemorrhagic 10.30 9.78 19 401390 9153 79333826
Rheumatoid factor positive 10.29 9.78 226 401183 59613 79283366
Abdominal wall cyst 10.29 9.78 5 401404 44 79342935
Atrioventricular block second degree 10.28 9.78 13 401396 7299 79335680
Maternal exposure during pregnancy 10.28 9.78 572 400837 135966 79207013
Retinitis 10.27 9.78 8 401401 5635 79337344
Bradyarrhythmia 10.26 9.78 4 401405 4142 79338837
Frequent bowel movements 10.26 9.78 97 401312 29442 79313537
Carbon dioxide decreased 10.24 9.78 40 401369 3488 79339491
Behaviour disorder 10.22 9.78 10 401399 6303 79336676
Vitreous haemorrhage 10.20 9.78 3 401406 3710 79339269
Nephrotic syndrome 10.19 9.78 26 401383 11148 79331831
Diastolic hypotension 10.18 9.78 8 401401 176 79342803
Long QT syndrome 10.15 9.78 9 401400 5946 79337033
Analgesic drug level decreased 10.12 9.78 4 401405 20 79342959
Hypertensive heart disease 10.10 9.78 45 401364 4161 79338818
Onychomadesis 10.10 9.78 7 401402 5235 79337744
Acute myeloid leukaemia 10.06 9.78 103 401306 30782 79312197
Sinus bradycardia 10.06 9.78 80 401329 25167 79317812
Stress cardiomyopathy 10.04 9.78 93 401316 11073 79331906
Judgement impaired 10.03 9.78 21 401388 1279 79341700
Pneumoconiosis 10.03 9.78 9 401400 239 79342740
Mastocytosis 10.03 9.78 13 401396 529 79342450
Mycobacterial infection 10.01 9.78 3 401406 3665 79339314
Counterfeit product administered 10.01 9.78 7 401402 128 79342851
SARS-CoV-2 sepsis 9.96 9.78 7 401402 129 79342850
Hemiplegia 9.95 9.78 40 401369 14899 79328080
Premature rupture of membranes 9.95 9.78 4 401405 4065 79338914
Sinus congestion 9.93 9.78 59 401350 19837 79323142
Hypervolaemia 9.92 9.78 153 401256 42537 79300442
Bacterial infection 9.91 9.78 105 401304 31175 79311804
Mean cell haemoglobin decreased 9.91 9.78 10 401399 6214 79336765
Skin papilloma 9.91 9.78 9 401400 5877 79337102
Penile oedema 9.90 9.78 10 401399 309 79342670
Dystonia 9.89 9.78 65 401344 21334 79321645
Varicella zoster virus infection 9.87 9.78 5 401404 4436 79338543
Mitral valve incompetence 9.84 9.78 94 401315 28471 79314508
Oropharyngeal discomfort 9.81 9.78 13 401396 7153 79335826
Temperature regulation disorder 9.79 9.78 9 401400 5844 79337135

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 | Suggest Off label Use Form| |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 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 **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** 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 **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** 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 **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** 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 **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** 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 **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** 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 **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** 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
OOX PDB_CHEM_ID
CHEMBL656 ChEMBL_ID
CHEMBL1200890 ChEMBL_ID
DB00497 DRUGBANK_ID
CHEMBL3989826 ChEMBL_ID
D010098 MESH_DESCRIPTOR_UI
5284603 PUBCHEM_CID
7093 IUPHAR_LIGAND_ID
C016026 MESH_SUPPLEMENTAL_RECORD_UI
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
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 0093-5731 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 0093-5732 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 0093-5733 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 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 0121-0826 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 0121-0827 SOLUTION 5 mg ORAL ANDA 35 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 0121-4827 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