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

Stem definitionDrug idCAS RN
opioid receptor antagonists/agonists, morphinan derivates 1845 57-27-2

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • morphine hydrochloride
  • morphine
  • morphin
  • morphina
  • morphine sulfate
  • morphine liposomal
  • morphine sulfate hydrate
  • morphine HCl
The principal alkaloid in opium and the prototype opiate analgesic and narcotic. Morphine has widespread effects in the central nervous system and on smooth muscle.
  • Molecular weight: 285.34
  • Formula: C17H19NO3
  • CLOGP: 0.57
  • LIPINSKI: 0
  • HAC: 4
  • HDO: 2
  • TPSA: 52.93
  • ALOGS: -1.45
  • ROTB: 0

  • Status: OFP

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

Drug dosage:

DoseUnitRoute
0.10 g O
30 mg P
30 mg R

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 1 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 57.14 mg/mL Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 4 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 5.85 ยตM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 24 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution) 2.30 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 26 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.65 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 2 hours Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
None FDA

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 hypersensitivity 6898.80 9.37 6233 172239 244777 50181875
Drug abuse 1076.72 9.37 1187 177285 58659 50367993
Toxicity to various agents 819.41 9.37 2101 176371 210398 50216254
Death 439.99 9.37 2285 176187 323094 50103558
Respiratory depression 406.60 9.37 338 178134 11672 50414980
Overdose 405.20 9.37 1007 177465 98720 50327932
Sedation 402.79 9.37 518 177954 30092 50396560
Respiratory arrest 365.65 9.37 489 177983 29520 50397132
Accidental overdose 357.04 9.37 391 178081 19142 50407510
Depressed level of consciousness 330.60 9.37 629 177843 51324 50375328
Constipation 290.81 9.37 1361 177111 184347 50242305
Sedation complication 284.94 9.37 241 178231 8525 50418127
Drug dependence 284.79 9.37 350 178122 19409 50407243
Pemphigus 254.84 9.37 56 178416 120110 50306542
Creatinine renal clearance decreased 254.80 9.37 259 178213 11622 50415030
Systemic lupus erythematosus 251.10 9.37 91 178381 140531 50286121
Miosis 250.58 9.37 195 178277 6115 50420537
Alopecia 247.70 9.37 300 178172 244747 50181905
Somnolence 239.69 9.37 1132 177340 153853 50272799
Glossodynia 219.94 9.37 67 178405 115502 50311150
Completed suicide 212.47 9.37 975 177497 130914 50295738
Arthropathy 197.79 9.37 160 178312 157746 50268906
Blood calcium decreased 187.25 9.37 293 178179 20413 50406239
Cardiac arrest 184.95 9.37 682 177790 82969 50343683
Drug withdrawal syndrome 183.95 9.37 323 178149 24758 50401894
Vomiting 181.20 9.37 2446 176026 458312 49968340
Hypotension 178.07 9.37 1429 177043 234040 50192612
Coma 176.20 9.37 520 177952 56359 50370293
Cardio-respiratory arrest 175.90 9.37 502 177970 53390 50373262
Abdominal discomfort 170.03 9.37 351 178121 231290 50195362
Contrast media allergy 163.13 9.37 97 178375 1930 50424722
Bradypnoea 162.75 9.37 113 178359 2961 50423691
Unresponsive to stimuli 160.48 9.37 342 178130 30267 50396385
Respiratory rate decreased 156.97 9.37 111 178361 2997 50423655
Substance abuse 152.05 9.37 122 178350 4002 50422650
Orthostatic hypotension 148.37 9.37 324 178148 29157 50397495
Hand deformity 147.46 9.37 85 178387 100114 50326538
Hyperaesthesia 129.59 9.37 152 178320 8021 50418631
Inadequate analgesia 119.21 9.37 87 178385 2471 50424181
Pericarditis 115.42 9.37 67 178405 78622 50348030
Myoclonus 114.82 9.37 193 178279 14277 50412375
Sinusitis 114.75 9.37 271 178201 170287 50256365
Cognitive disorder 114.13 9.37 379 178093 43744 50382908
Anti-cyclic citrullinated peptide antibody positive 112.53 9.37 54 178418 70533 50356119
Arthralgia 112.48 9.37 998 177474 437704 49988948
Product dose omission issue 111.42 9.37 308 178164 183530 50243122
Intestinal pseudo-obstruction 111.26 9.37 54 178418 700 50425952
Drug ineffective 110.36 9.37 2134 176338 817199 49609453
Fatigue 106.52 9.37 1807 176665 705794 49720858
Helicobacter infection 105.64 9.37 23 178449 49679 50376973
Delirium 105.03 9.37 335 178137 37857 50388795
Folliculitis 104.79 9.37 9 178463 39216 50387436
Swelling 103.72 9.37 362 178110 200510 50226142
Off label use 103.67 9.37 1122 177350 473304 49953348
Muscle injury 103.43 9.37 7 178465 37104 50389548
Malignant neoplasm progression 101.81 9.37 493 177979 67631 50359021
Exposure via ingestion 99.27 9.37 81 178391 2722 50423930
Mental status changes 97.79 9.37 316 178156 35956 50390696
Contraindicated product administered 97.55 9.37 240 178232 148718 50277934
Sleep disorder due to general medical condition, insomnia type 97.11 9.37 3 178469 31444 50395208
Wound 96.03 9.37 140 178332 105654 50320998
Poisoning 93.64 9.37 162 178310 12267 50414385
Nasopharyngitis 93.45 9.37 357 178115 192570 50234082
Duodenal ulcer perforation 93.18 9.37 23 178449 45588 50381064
Hallucination 88.86 9.37 363 178109 46294 50380358
Maternal exposure during pregnancy 88.60 9.37 279 178193 159499 50267153
Device expulsion 88.11 9.37 3 178469 28819 50397833
Asphyxia 86.16 9.37 101 178371 5326 50421326
Drug screen positive 85.70 9.37 81 178391 3321 50423331
Drug abuser 84.29 9.37 74 178398 2754 50423898
Irritable bowel syndrome 84.08 9.37 38 178434 51403 50375249
Balance disorder 83.58 9.37 479 177993 70111 50356541
White blood cell count abnormal 82.66 9.37 99 178373 5341 50421311
Acute chest syndrome 82.01 9.37 42 178430 615 50426037
Maternal exposure during delivery 80.59 9.37 48 178424 958 50425694
Drug diversion 78.76 9.37 43 178429 722 50425930
Soft tissue disorder 78.10 9.37 85 178387 4129 50422523
Injection site erythema 77.42 9.37 90 178382 74846 50351806
Hepatic enzyme increased 76.08 9.37 240 178232 137140 50289512
Infusion related reaction 75.64 9.37 324 178148 169233 50257419
Weight increased 74.88 9.37 412 178060 201479 50225173
Ill-defined disorder 72.68 9.37 52 178420 54602 50372050
Intentional product misuse 72.55 9.37 342 178130 46392 50380260
Injection site pain 71.01 9.37 181 178291 110843 50315809
Apnoea 70.65 9.37 104 178368 6862 50419790
Discomfort 69.86 9.37 176 178296 108204 50318448
Respiratory failure 69.07 9.37 554 177918 90627 50336025
Joint swelling 65.80 9.37 551 177921 244735 50181917
Confusional state 63.47 9.37 964 177508 184964 50241688
Injection site reaction 63.45 9.37 50 178422 49982 50376670
Rheumatoid factor positive 63.01 9.37 50 178422 49809 50376843
Gastrointestinal disorder 62.74 9.37 151 178321 94305 50332347
Poisoning deliberate 62.07 9.37 105 178367 7807 50418845
Abortion spontaneous 62.05 9.37 35 178437 41737 50384915
Hypoxia 60.56 9.37 347 178125 50776 50375876
Headache 60.52 9.37 1344 177128 505191 49921461
Anterior spinal artery syndrome 59.92 9.37 19 178453 67 50426585
Hypercapnia 58.80 9.37 77 178395 4550 50422102
Product use issue 58.76 9.37 299 178173 149176 50277476
Rash 58.04 9.37 1141 177331 436330 49990322
Dilatation intrahepatic duct acquired 57.54 9.37 33 178439 612 50426040
Macular degeneration 55.93 9.37 143 178329 14245 50412407
Withdrawal syndrome 54.61 9.37 161 178311 17429 50409223
Nausea 53.67 9.37 3018 175454 702380 49724272
Impaired healing 53.45 9.37 103 178369 69683 50356969
Injection site pruritus 51.73 9.37 40 178432 40371 50386281
Therapeutic product effect decreased 50.75 9.37 277 178195 135773 50290879
Respiratory acidosis 49.96 9.37 82 178390 5946 50420706
Injection site swelling 48.98 9.37 45 178427 41728 50384924
Blister 48.84 9.37 147 178325 85271 50341381
Obliterative bronchiolitis 48.37 9.37 45 178427 1808 50424844
Treatment failure 48.23 9.37 286 178186 137351 50289301
Hypersensitivity 47.55 9.37 507 177965 214654 50211998
Urinary retention 46.91 9.37 200 178272 25990 50400662
Drug withdrawal syndrome neonatal 46.69 9.37 44 178428 1797 50424855
Condition aggravated 46.56 9.37 752 177720 296306 50130346
Aspiration 45.67 9.37 101 178371 9163 50417489
Mobility decreased 44.78 9.37 455 178017 79493 50347159
Acidosis 44.35 9.37 106 178366 10121 50416531
Contusion 43.17 9.37 226 178246 111957 50314695
Lethargy 42.82 9.37 310 178162 49122 50377530
Synovitis 42.02 9.37 260 178212 123605 50303047
Sphincter of Oddi dysfunction 41.45 9.37 22 178450 348 50426304
Peripheral swelling 40.52 9.37 498 177974 205438 50221214
Cough 40.41 9.37 603 177869 240661 50185991
Cardiac failure congestive 39.61 9.37 158 178314 84224 50342428
Plasma cell myeloma 39.34 9.37 216 178256 31106 50395546
Accidental death 39.19 9.37 39 178433 1705 50424947
Anaphylactic reaction 39.06 9.37 325 178147 53730 50372922
Pregnancy 38.20 9.37 29 178443 29548 50397104
Nasal congestion 37.81 9.37 77 178395 51043 50375609
Pulseless electrical activity 37.66 9.37 78 178394 6763 50419889
Iodine allergy 37.65 9.37 26 178446 675 50425977
Agitation 37.00 9.37 318 178154 53066 50373586
Gangrene 36.45 9.37 62 178410 4630 50422022
Drug tolerance 36.36 9.37 64 178408 4912 50421740
Visceral congestion 36.23 9.37 19 178453 293 50426359
Neutropenic sepsis 36.10 9.37 121 178351 14026 50412626
COVID-19 35.62 9.37 69 178403 46593 50380059
Sepsis 34.67 9.37 660 177812 132265 50294387
Accidental exposure to product by child 34.63 9.37 29 178443 1011 50425641
Diarrhoea 34.62 9.37 1710 176762 586766 49839886
Narcotic bowel syndrome 34.32 9.37 14 178458 116 50426536
Rheumatoid nodule 33.80 9.37 3 178469 12732 50413920
Foetal megacystis 33.79 9.37 10 178462 26 50426626
Pulmonary oedema 33.65 9.37 291 178181 48647 50378005
Wrong technique in product usage process 33.58 9.37 93 178379 55417 50371235
Sopor 33.56 9.37 14 178458 19865 50406787
Dizziness 33.43 9.37 948 177524 345421 50081231
Pneumonia viral 33.12 9.37 74 178398 6760 50419892
Mucosal inflammation 32.64 9.37 248 178224 39894 50386758
Post procedural complication 32.38 9.37 122 178350 14982 50411670
Abdominal pain 31.54 9.37 1072 177400 235156 50191496
Systemic mastocytosis 31.52 9.37 14 178458 146 50426506
Drug resistance 31.07 9.37 14 178458 18975 50407677
Pancreatic fibrosis 30.91 9.37 12 178460 86 50426566
Brain oedema 30.86 9.37 105 178367 12265 50414387
Tonsillar disorder 30.70 9.37 27 178445 1007 50425645
Oxygen saturation decreased 30.70 9.37 394 178078 72854 50353798
Hip arthroplasty 29.88 9.37 38 178434 30391 50396261
Psoriatic arthropathy 29.80 9.37 77 178395 46955 50379697
Cholestasis 29.80 9.37 172 178300 25229 50401423
Asthma 29.02 9.37 190 178282 89147 50337505
Disease progression 28.88 9.37 487 177985 95379 50331273
Pruritus allergic 28.85 9.37 27 178445 1093 50425559
Implant site extravasation 28.82 9.37 19 178453 456 50426196
Cyanosis 28.79 9.37 118 178354 15066 50411586
Sternal fracture 28.09 9.37 35 178437 1967 50424685
Injection site rash 27.95 9.37 11 178461 16166 50410486
Basal cell carcinoma 27.57 9.37 25 178447 23331 50403321
Loss of personal independence in daily activities 27.57 9.37 140 178332 69910 50356742
Encephalopathy 27.25 9.37 208 178264 33503 50393149
Pulmonary congestion 26.97 9.37 116 178356 15131 50411521
Intentional product use issue 26.84 9.37 160 178312 76758 50349894
Skin candida 26.79 9.37 28 178444 1298 50425354
Allodynia 26.64 9.37 21 178451 671 50425981
Colitis microscopic 26.59 9.37 66 178406 6454 50420198
Femur fracture 26.39 9.37 58 178414 37406 50389246
Coronary artery disease 26.31 9.37 40 178432 29686 50396966
No adverse event 26.20 9.37 49 178423 33529 50393123
Swollen joint count increased 25.89 9.37 10 178462 14863 50411789
Syncope 25.09 9.37 237 178235 102765 50323887
C-reactive protein abnormal 25.02 9.37 37 178435 27772 50398880
Retinitis 24.91 9.37 32 178440 1855 50424797
Pupil fixed 24.83 9.37 29 178443 1523 50425129
Myalgia 24.66 9.37 300 178172 124019 50302633
Dyspnoea exertional 24.63 9.37 95 178377 51138 50375514
Heavy menstrual bleeding 24.58 9.37 12 178460 15525 50411127
Alveolitis 24.51 9.37 37 178435 2497 50424155
Erythema 24.46 9.37 366 178106 146048 50280604
Breast cancer metastatic 24.14 9.37 86 178386 10278 50416374
Rhythm idioventricular 24.10 9.37 12 178460 165 50426487
Vascular resistance systemic decreased 23.90 9.37 10 178462 89 50426563
Hospitalisation 23.87 9.37 141 178331 67796 50358856
Rheumatic fever 23.83 9.37 15 178457 16852 50409800
Hypoxic-ischaemic encephalopathy 23.78 9.37 46 178426 3796 50422856
Cardiac output decreased 23.77 9.37 22 178450 878 50425774
Tendonitis 23.40 9.37 15 178457 16690 50409962
Anaesthesia 23.31 9.37 15 178457 345 50426307
Progressive multifocal leukoencephalopathy 22.97 9.37 6 178466 11451 50415201
Respiratory distress 22.93 9.37 185 178287 30304 50396348
Musculoskeletal stiffness 22.92 9.37 317 178155 128164 50298488
Spinal epidural haemorrhage 22.88 9.37 10 178462 100 50426552
Injection site bruising 22.68 9.37 61 178411 36707 50389945
Muscle twitching 22.55 9.37 111 178361 15320 50411332
Hypoventilation 21.93 9.37 45 178427 3876 50422776
Bradycardia 21.92 9.37 334 178138 64092 50362560
Pupillary reflex impaired 21.91 9.37 30 178442 1851 50424801
Antinuclear antibody negative 21.85 9.37 12 178460 204 50426448
Peripheral nerve injury 21.80 9.37 15 178457 387 50426265
Transient ischaemic attack 21.77 9.37 51 178421 32159 50394493
Knee arthroplasty 21.72 9.37 60 178412 35786 50390866
Neuroendocrine tumour of the lung 21.70 9.37 6 178466 11 50426641
Gallbladder cholesterolosis 21.51 9.37 19 178453 713 50425939
Seronegative arthritis 21.23 9.37 31 178441 2030 50424622
Implant site discharge 21.21 9.37 10 178462 121 50426531
Metastases to bone 21.21 9.37 122 178350 17873 50408779
Libido increased 21.19 9.37 24 178448 1219 50425433
Metastases to eye 21.14 9.37 10 178462 122 50426530
Therapy interrupted 21.02 9.37 24 178448 20128 50406524
Excessive eye blinking 20.97 9.37 21 178451 925 50425727
Catheter site granuloma 20.92 9.37 5 178467 3 50426649
Calcium deficiency 20.90 9.37 21 178451 929 50425723
Anaesthetic complication 20.77 9.37 28 178444 1702 50424950
Urinary bladder rupture 20.65 9.37 10 178462 129 50426523
Multiple sclerosis relapse 20.44 9.37 80 178392 42884 50383768
Spinal cord injury 20.32 9.37 18 178454 678 50425974
Small intestinal obstruction 20.30 9.37 111 178361 15957 50410695
Serotonin syndrome 20.27 9.37 153 178319 24560 50402092
Faecaloma 20.13 9.37 63 178409 7045 50419607
Injection site warmth 20.05 9.37 12 178460 13854 50412798
Arterial occlusive disease 19.96 9.37 49 178423 4759 50421893
Nasal disorder 19.95 9.37 32 178440 2276 50424376
Administration site abscess 19.90 9.37 6 178466 17 50426635
Increased bronchial secretion 19.86 9.37 26 178446 1536 50425116
Incoherent 19.60 9.37 45 178427 4185 50422467
Intentional self-injury 19.60 9.37 32 178440 23080 50403572
Administration site induration 19.18 9.37 6 178466 20 50426632
Diffuse axonal injury 19.14 9.37 8 178464 71 50426581
Patient uncooperative 19.08 9.37 10 178462 154 50426498
Disorientation 18.93 9.37 200 178272 35284 50391368
Spinal cord compression 18.92 9.37 41 178431 3668 50422984
Interstitial lung disease 18.87 9.37 110 178362 53066 50373586
Hallucination, tactile 18.76 9.37 11 178461 213 50426439
Administration site discharge 18.74 9.37 6 178466 22 50426630
Hallucination, visual 18.62 9.37 111 178361 16471 50410181
Cerebrovascular accident 18.58 9.37 229 178243 94451 50332201
Blood pH decreased 18.49 9.37 32 178440 2423 50424229
Breast cancer 18.46 9.37 83 178389 42807 50383845
Pain in extremity 18.36 9.37 781 177691 272084 50154568
Foetal heart rate abnormal 18.21 9.37 15 178457 511 50426141
Hyperhidrosis 18.10 9.37 428 178044 88998 50337654
Toxicologic test abnormal 17.96 9.37 16 178456 607 50426045
Joint effusion 17.82 9.37 12 178460 13009 50413643
Soft tissue injury 17.79 9.37 24 178448 1460 50425192
Complex regional pain syndrome 17.73 9.37 28 178444 1965 50424687
Therapy cessation 17.72 9.37 41 178431 25970 50400682
Hepatocellular injury 17.68 9.37 154 178318 25793 50400859
Dependence 17.60 9.37 27 178445 1848 50424804
Tissue infiltration 17.55 9.37 15 178457 538 50426114
Toxic leukoencephalopathy 17.53 9.37 16 178456 627 50426025
Weaning failure 17.43 9.37 12 178460 310 50426342
Central nervous system injury 17.38 9.37 9 178463 135 50426517
Suicide attempt 17.32 9.37 109 178363 51623 50375029
Cancer pain 17.28 9.37 32 178440 2555 50424097
Congenital pulmonary hypertension 17.27 9.37 7 178465 57 50426595
Blood phosphorus decreased 17.22 9.37 40 178432 3749 50422903
Basal ganglion degeneration 17.05 9.37 13 178459 395 50426257
Product quality issue 16.99 9.37 54 178418 30804 50395848
Coombs positive haemolytic anaemia 16.87 9.37 12 178460 327 50426325
Foetal monitoring abnormal 16.86 9.37 10 178462 198 50426454
Abnormal behaviour 16.86 9.37 123 178349 19535 50407117
Posterior reversible encephalopathy syndrome 16.81 9.37 100 178372 14828 50411824
Full blood count abnormal 16.64 9.37 36 178436 23352 50403300
Throat irritation 16.60 9.37 53 178419 30186 50396466
Peptic ulcer perforation 16.54 9.37 9 178463 150 50426502
Administration site odour 16.50 9.37 6 178466 35 50426617
White blood cell count decreased 16.45 9.37 301 178171 116421 50310231
Theft 16.20 9.37 7 178465 68 50426584
Breakthrough pain 16.12 9.37 20 178452 1119 50425533
Thymus disorder 16.01 9.37 10 178462 218 50426434
Respiratory rate increased 16 9.37 81 178391 11304 50415348
Nervous system disorder 15.97 9.37 105 178367 16118 50410534
Chronic kidney disease 15.92 9.37 79 178393 39692 50386960
Pituitary apoplexy 15.81 9.37 8 178464 114 50426538
Hostility 15.81 9.37 25 178447 1757 50424895
Fluid retention 15.80 9.37 109 178363 50540 50376112
Injection site urticaria 15.75 9.37 12 178460 12205 50414447
Sinus tachycardia 15.75 9.37 129 178343 21225 50405427
Infection 15.73 9.37 477 177995 172477 50254175
Bronchitis 15.51 9.37 266 178206 103893 50322759
Pulmonary embolism 15.49 9.37 469 178003 101235 50325417
Tenosynovitis 15.48 9.37 9 178463 10556 50416096
Tachycardia 15.45 9.37 461 178011 99302 50327350
Parkinsonism 15.31 9.37 6 178466 8841 50417811
Injection site discolouration 15.29 9.37 3 178469 6971 50419681
Ear pain 15.22 9.37 50 178422 28233 50398419
Herpes simplex reactivation 15.18 9.37 12 178460 385 50426267
Palpitations 15.17 9.37 238 178234 94268 50332384
Acute kidney injury 15.15 9.37 965 177507 227093 50199559
Administration site haemorrhage 15.12 9.37 7 178465 81 50426571
Abortion induced 15.11 9.37 7 178465 9337 50417315
Cytomegalovirus infection 15.11 9.37 25 178447 17937 50408715
Device difficult to use 15.09 9.37 8 178464 9878 50416774
Myocardial infarction 15.05 9.37 222 178250 88805 50337847
Epidural analgesia 15 9.37 6 178466 47 50426605
Eye pain 14.83 9.37 51 178421 28398 50398254
Hepatic function abnormal 14.82 9.37 62 178410 32619 50394033
Retrograde amnesia 14.81 9.37 12 178460 399 50426253
Suspected suicide 14.73 9.37 47 178425 5310 50421342
Stomatitis 14.71 9.37 260 178212 101084 50325568
Skin reaction 14.67 9.37 80 178392 11488 50415164
Osteoarthritis 14.59 9.37 163 178309 68443 50358209
Prescribed underdose 14.56 9.37 21 178451 15928 50410724
PO2 decreased 14.56 9.37 21 178451 1360 50425292
Post-traumatic neck syndrome 14.52 9.37 25 178447 1885 50424767
Mydriasis 14.51 9.37 75 178397 10552 50416100
Influenza like illness 14.51 9.37 131 178341 57328 50369324
Type 2 diabetes mellitus 14.51 9.37 67 178405 34308 50392344
Neuralgia 14.50 9.37 129 178343 21734 50404918
Neuromuscular block prolonged 14.49 9.37 13 178459 498 50426154
Keratitis 14.47 9.37 29 178443 2456 50424196
Documented hypersensitivity to administered product 14.45 9.37 13 178459 500 50426152
Injection site cyst 14.38 9.37 6 178466 53 50426599
Withdrawal catatonia 14.38 9.37 6 178466 53 50426599
Panniculitis 14.34 9.37 6 178466 8497 50418155
Stroke volume increased 14.24 9.37 4 178468 8 50426644
Genital haemorrhage 14.05 9.37 3 178469 6571 50420081
Eye disorder 14.05 9.37 28 178444 18711 50407941
Neoplasm progression 14.02 9.37 161 178311 28996 50397656
Suspected product tampering 13.95 9.37 3 178469 0 50426652
Infusion site granuloma 13.95 9.37 3 178469 0 50426652
Agonal death struggle 13.95 9.37 3 178469 0 50426652
Drug eruption 13.94 9.37 40 178432 23566 50403086
Dehydration 13.85 9.37 664 177808 151785 50274867
Skin cancer 13.76 9.37 8 178464 9386 50417266
Heat stroke 13.75 9.37 14 178458 629 50426023
Myelodysplastic syndrome 13.74 9.37 20 178452 15112 50411540
Product name confusion 13.64 9.37 6 178466 61 50426591
Paranasal cyst 13.58 9.37 10 178462 288 50426364
Flushing 13.56 9.37 161 178311 66854 50359798
Infusion 13.55 9.37 8 178464 157 50426495
Metastasis 13.54 9.37 40 178432 4335 50422317
Hypercreatininaemia 13.47 9.37 11 178461 370 50426282
Livedo reticularis 13.44 9.37 26 178446 2146 50424506
Vascular malformation 13.43 9.37 10 178462 293 50426359
Impaired work ability 13.43 9.37 17 178455 13623 50413029
Cardiac failure 13.42 9.37 188 178284 75852 50350800
Spinal cord paralysis 13.36 9.37 5 178467 32 50426620
Carcinoid tumour 13.29 9.37 10 178462 298 50426354
Haemangioma of skin 13.23 9.37 10 178462 300 50426352
Drug tolerance increased 13.19 9.37 9 178463 229 50426423
Feeling jittery 13.11 9.37 12 178460 11148 50415504
Occupational dermatitis 13.10 9.37 5 178467 34 50426618
Nodule 13.10 9.37 25 178447 16978 50409674
Blood glucose increased 13.06 9.37 175 178297 71149 50355503
Metastases to spine 12.99 9.37 30 178442 2801 50423851
Transplant rejection 12.96 9.37 9 178463 9600 50417052
Implant site infection 12.94 9.37 16 178456 892 50425760
Menstruation irregular 12.79 9.37 3 178469 6159 50420493
Adverse event 12.77 9.37 96 178376 43667 50382985
Clonus 12.75 9.37 38 178434 4137 50422515
Epidural haemorrhage 12.74 9.37 7 178465 119 50426533
Polyarthritis 12.73 9.37 6 178466 7921 50418731
Vaginal flatulence 12.73 9.37 9 178463 243 50426409
Myocardial fibrosis 12.70 9.37 14 178458 690 50425962
Fear-related avoidance of activities 12.69 9.37 7 178465 120 50426532
Liver disorder 12.68 9.37 78 178394 37144 50389508
Product selection error 12.63 9.37 6 178466 74 50426578
Sickle cell anaemia with crisis 12.62 9.37 40 178432 4503 50422149
Medication error 12.60 9.37 188 178284 35916 50390736
Gastrooesophageal reflux disease 12.43 9.37 192 178280 76236 50350416
Suicidal ideation 12.41 9.37 130 178342 55255 50371397
Uterine enlargement 12.41 9.37 17 178455 1049 50425603
Splenic injury 12.24 9.37 8 178464 189 50426463
Therapeutic response decreased 12.22 9.37 107 178365 47124 50379528
Myoglobin urine 12.22 9.37 4 178468 16 50426636
Uveitis 12.19 9.37 9 178463 9301 50417351
Liver function test abnormal 12.18 9.37 222 178250 44117 50382535
Hypoacusis 12.18 9.37 35 178437 20612 50406040
Substance use 12.16 9.37 10 178462 340 50426312
Dyspnoea 12.13 9.37 1720 176752 545888 49880764
Pemphigoid 12.02 9.37 3 178469 5904 50420748
Hip surgery 12.01 9.37 28 178444 2630 50424022
Back pain 11.99 9.37 916 177556 219114 50207538
Hypothermia 11.97 9.37 78 178394 11938 50414714
Blood pressure diastolic increased 11.93 9.37 55 178417 7388 50419264
Anaesthetic complication pulmonary 11.90 9.37 5 178467 45 50426607
Hypertension 11.90 9.37 616 177856 210587 50216065
Analgesic therapy 11.88 9.37 3 178469 3 50426649
Chronic idiopathic pain syndrome 11.88 9.37 3 178469 3 50426649
Exposure to toxic agent 11.85 9.37 34 178438 3624 50423028
Cardiac output increased 11.83 9.37 7 178465 138 50426514
Stridor 11.80 9.37 31 178441 3138 50423514
Myopathy 11.75 9.37 9 178463 9130 50417522
Intestinal strangulation 11.65 9.37 6 178466 89 50426563
Denture wearer 11.64 9.37 8 178464 206 50426446
Brain injury 11.61 9.37 47 178425 5967 50420685
Cardiopulmonary failure 11.56 9.37 32 178440 3341 50423311
Terminal state 11.55 9.37 24 178448 2086 50424566
Abdominal hernia 11.41 9.37 38 178434 4391 50422261
Postoperative ileus 11.40 9.37 11 178461 463 50426189
Pleuritic pain 11.29 9.37 49 178423 6417 50420235
Antinuclear antibody positive 11.28 9.37 4 178468 6268 50420384
Schizophrenia 11.27 9.37 6 178466 7391 50419261
Sinus congestion 11.24 9.37 20 178452 13951 50412701
Blood pressure systolic decreased 11.20 9.37 45 178427 5694 50420958
Myelosuppression 11.20 9.37 19 178453 13498 50413154
Haematotoxicity 11.18 9.37 7 178465 7888 50418764
Gastritis fungal 11.14 9.37 6 178466 98 50426554
Intraventricular haemorrhage neonatal 11.11 9.37 7 178465 155 50426497
Blood pressure diastolic abnormal 11.07 9.37 10 178462 9351 50417301
Incubator therapy 11.05 9.37 4 178468 23 50426629
Pathological fracture 11.04 9.37 55 178417 7627 50419025
Gastrointestinal haemorrhage 10.99 9.37 187 178285 73134 50353518
Therapeutic product effect prolonged 10.99 9.37 9 178463 304 50426348
Ischaemic stroke 10.98 9.37 25 178447 15923 50410729
Colitis 10.97 9.37 194 178278 38335 50388317
Urinary tract obstruction 10.90 9.37 21 178451 1727 50424925
Rhinitis 10.90 9.37 8 178464 8293 50418359
Influenza 10.78 9.37 237 178235 89301 50337351
Laryngectomy 10.77 9.37 4 178468 25 50426627
Inappropriate schedule of product administration 10.51 9.37 184 178288 71647 50355005
Metastases to oesophagus 10.51 9.37 4 178468 27 50426625
Rash pruritic 10.44 9.37 113 178359 47733 50378919
Pleural effusion 10.43 9.37 368 178104 81086 50345566
Asthenia 10.42 9.37 976 177496 318066 50108586
Bone marrow failure 10.42 9.37 56 178416 27568 50399084
Thirst decreased 10.41 9.37 8 178464 246 50426406
Sepsis neonatal 10.38 9.37 10 178462 420 50426232
Delayed recovery from anaesthesia 10.36 9.37 13 178459 736 50425916
Blood alkaline phosphatase increased 10.35 9.37 188 178284 37338 50389314
Ileus 10.34 9.37 81 178391 13148 50413504
Large intestine perforation 10.31 9.37 53 178419 7441 50419211
Product storage error 10.29 9.37 17 178455 12207 50414445
Aplastic anaemia 10.27 9.37 54 178418 7649 50419003
Tooth hypoplasia 10.22 9.37 5 178467 66 50426586
Non-small cell lung cancer 10.20 9.37 28 178444 2909 50423743
Lung cancer metastatic 10.18 9.37 24 178448 2271 50424381
Self-medication 10.15 9.37 24 178448 2275 50424377
Spleen congestion 10.15 9.37 6 178466 118 50426534
Monoplegia 10.14 9.37 27 178445 2756 50423896
Night sweats 10.11 9.37 73 178399 33501 50393151
Blood creatine phosphokinase MB increased 10.10 9.37 16 178456 1126 50425526
Pocket erosion 10.08 9.37 3 178469 8 50426644
Wound infection staphylococcal 10.01 9.37 25 178447 2454 50424198
Granulocytopenia 10 9.37 3 178469 5228 50421424
Hypokalaemia 9.93 9.37 392 178080 87600 50339052
Malnutrition 9.90 9.37 80 178392 13109 50413543
Injection site induration 9.90 9.37 9 178463 8388 50418264
Hyperreflexia 9.88 9.37 40 178432 5078 50421574
Intestinal perforation 9.82 9.37 67 178405 10412 50416240
Sleep disorder due to a general medical condition 9.81 9.37 7 178465 7364 50419288
Cor pulmonale 9.79 9.37 21 178451 1866 50424786
Loss of consciousness 9.79 9.37 456 178016 103897 50322755
Factitious disorder 9.78 9.37 5 178467 73 50426579
Adiposis dolorosa 9.75 9.37 8 178464 271 50426381
Aspergillus infection 9.73 9.37 6 178466 6815 50419837
Injection site mass 9.68 9.37 26 178446 15654 50410998
Meningitis chemical 9.68 9.37 6 178466 129 50426523
Dysphonia 9.67 9.37 89 178383 38803 50387849
Bone cancer 9.64 9.37 16 178456 1171 50425481
Alkalosis 9.60 9.37 8 178464 277 50426375
Respiratory paralysis 9.59 9.37 3 178469 10 50426642
PO2 abnormal 9.59 9.37 3 178469 10 50426642
Cerebrospinal fluid leakage 9.58 9.37 14 178458 918 50425734
Troponin increased 9.54 9.37 55 178417 8063 50418589
Pulmonary infarction 9.49 9.37 24 178448 2374 50424278
Nerve block 9.49 9.37 10 178462 468 50426184
Haemorrhage 9.47 9.37 132 178340 53309 50373343
Intestinal obstruction 9.45 9.37 138 178334 26245 50400407
Buttock injury 9.43 9.37 7 178465 204 50426448
Hyperchloraemia 9.43 9.37 12 178460 689 50425963
Atrial fibrillation 9.39 9.37 280 178192 101465 50325187

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
Toxicity to various agents 1367.30 10.18 2581 125470 171080 29275396
Drug hypersensitivity 1284.49 10.18 1530 126521 66876 29379600
Drug abuse 1213.55 10.18 1607 126444 78276 29368200
Respiratory depression 623.09 10.18 496 127555 13027 29433449
Overdose 579.51 10.18 1149 126902 78670 29367806
Drug dependence 468.35 10.18 514 127537 20467 29426009
Accidental overdose 397.85 10.18 434 127617 17159 29429317
Substance abuse 293.59 10.18 240 127811 6547 29439929
Miosis 284.65 10.18 253 127798 7756 29438720
Death 250.25 10.18 2415 125636 339669 29106807
Somnolence 250.18 10.18 934 127117 93021 29353455
Respiratory arrest 249.25 10.18 421 127630 25412 29421064
Drug withdrawal syndrome 192.23 10.18 307 127744 17677 29428799
Unresponsive to stimuli 191.97 10.18 370 127681 24756 29421720
Off label use 168.58 10.18 701 127350 300099 29146377
Delirium 158.38 10.18 451 127600 38946 29407530
Poisoning 157.27 10.18 205 127846 9788 29436688
Sedation 155.21 10.18 274 127777 17131 29429345
Hyperaesthesia 150.71 10.18 123 127928 3346 29443130
Pulmonary oedema 145.16 10.18 461 127590 42274 29404202
Coma 143.66 10.18 436 127615 39014 29407462
Bradypnoea 142.51 10.18 102 127949 2269 29444207
Confusional state 140.91 10.18 992 127059 126885 29319591
Mental status changes 139.57 10.18 399 127652 34528 29411948
Depressed level of consciousness 132.37 10.18 406 127645 36536 29409940
Inadequate analgesia 127.88 10.18 100 127951 2554 29443922
Accidental death 127.03 10.18 91 127960 2027 29444449
Malignant neoplasm progression 127.02 10.18 644 127407 73215 29373261
Constipation 126.55 10.18 887 127164 113273 29333203
Cardio-respiratory arrest 123.79 10.18 490 127561 50111 29396365
Intentional product misuse 123.32 10.18 380 127671 34281 29412195
Drug screen positive 119.28 10.18 112 127939 3689 29442787
Asphyxia 107.90 10.18 124 127927 5191 29441285
Respiratory rate decreased 106.30 10.18 79 127972 1866 29444610
Acute chest syndrome 105.97 10.18 43 128008 278 29446198
Lethargy 104.36 10.18 379 127672 37201 29409275
Cardiac arrest 104.33 10.18 681 127370 84910 29361566
Completed suicide 102.78 10.18 706 127345 89540 29356936
Withdrawal syndrome 94.08 10.18 170 127881 10822 29435654
Drug abuser 85.75 10.18 94 127957 3733 29442743
Brain oedema 82.56 10.18 171 127880 12049 29434427
Apnoea 79.13 10.18 114 127937 5988 29440488
Agitation 78.99 10.18 434 127617 50870 29395606
Vomiting 76.86 10.18 1318 126733 210942 29235534
Product dose omission issue 76.46 10.18 192 127859 96191 29350285
Drug ineffective 73.58 10.18 1119 126932 362051 29084425
Product use in unapproved indication 67.40 10.18 175 127876 86700 29359776
Myocardial infarction 66.61 10.18 249 127802 110047 29336429
Pulmonary congestion 65.97 10.18 158 127893 12278 29434198
Myoclonus 64.16 10.18 163 127888 13146 29433330
Exposure to toxic agent 60.76 10.18 65 127986 2510 29443966
Cardiac failure congestive 59.60 10.18 154 127897 76427 29370049
Sedation complication 58.96 10.18 47 128004 1235 29445241
Myalgia 57.48 10.18 149 127902 73870 29372606
Plasma cell myeloma 57.13 10.18 314 127737 36801 29409675
Nausea 56.29 10.18 1644 126407 287611 29158865
COVID-19 53.82 10.18 46 128005 35968 29410508
Cytomegalovirus infection 53.33 10.18 17 128034 23198 29423278
Pain 51.69 10.18 1035 127016 170397 29276079
Sphincter of Oddi dysfunction 51.10 10.18 20 128031 116 29446360
Oxygen saturation decreased 46.69 10.18 344 127707 44593 29401883
Cough 46.14 10.18 340 127711 126387 29320089
Treatment failure 45.21 10.18 56 127995 36883 29409593
Exposure via ingestion 44.23 10.18 49 128002 1969 29444507
Hypoxia 43.83 10.18 353 127698 47026 29399450
Hypogonadism male 43.74 10.18 22 128029 248 29446228
Drug resistance 42.49 10.18 20 128031 21520 29424956
Drug diversion 42.09 10.18 32 128019 783 29445693
Cerebrovascular accident 41.14 10.18 182 127869 76729 29369747
Pneumonia aspiration 40.92 10.18 286 127765 36451 29410025
Dizziness 40.82 10.18 577 127474 189107 29257369
Hypoxic-ischaemic encephalopathy 40.20 10.18 69 127982 4215 29442261
Hallucination 39.67 10.18 330 127721 44382 29402094
Renal impairment 39.66 10.18 199 127852 81134 29365342
Syncope 39.17 10.18 200 127851 81171 29365305
Drug use disorder 38.74 10.18 60 127991 3362 29443114
Diarrhoea 38.54 10.18 1122 126929 331576 29114900
Melaena 38.43 10.18 47 128004 31129 29415347
Coronary artery disease 38.23 10.18 84 127967 44106 29402370
Hyperhidrosis 37.94 10.18 437 127614 64103 29382373
Opiates positive 37.35 10.18 25 128026 497 29445979
Hospitalisation 36.91 10.18 91 127960 45897 29400579
Hypoventilation 36.72 10.18 53 127998 2788 29443688
Respiratory acidosis 35.84 10.18 66 127985 4262 29442214
Respiratory distress 35.79 10.18 250 127801 31856 29414620
Cancer pain 33.63 10.18 46 128005 2301 29444175
Clumsiness 32.03 10.18 36 128015 1470 29445006
Diaphragmatic spasm 31.79 10.18 13 128038 86 29446390
Serotonin syndrome 31.68 10.18 155 127896 17357 29429119
Basal cell carcinoma 31.41 10.18 17 128034 16893 29429583
Stupor 30.91 10.18 48 128003 2696 29443780
Blood pH decreased 30.85 10.18 42 128009 2091 29444385
Urinary retention 30.77 10.18 240 127811 31658 29414818
Faecal volume decreased 29.91 10.18 13 128038 102 29446374
Diabetes mellitus inadequate control 29.49 10.18 8 128043 12126 29434350
Neutropenia 29.25 10.18 398 127653 131313 29315163
Drug tolerance 29.06 10.18 41 128010 2112 29444364
Haematuria 29.05 10.18 96 127955 44043 29402433
PCO2 increased 28.87 10.18 22 128029 540 29445936
Metastases to bone 28.45 10.18 101 127950 9797 29436679
Dyspnoea 28.45 10.18 1142 126909 325590 29120886
Tubulointerstitial nephritis 28.28 10.18 21 128030 17622 29428854
Leukopenia 28.10 10.18 133 127918 55070 29391406
Blood glucose increased 27.80 10.18 146 127905 58838 29387638
Aspiration 27.67 10.18 102 127949 10078 29436398
Visual acuity reduced 27.56 10.18 15 128036 14861 29431615
Cardiac failure 27.28 10.18 216 127835 79071 29367405
Breakthrough pain 27.16 10.18 21 128030 527 29445949
Atrial fibrillation 26.91 10.18 310 127741 105336 29341140
Hepatic function abnormal 26.80 10.18 84 127967 39175 29407301
Haematochezia 26.78 10.18 77 127974 36906 29409570
Arthralgia 25.82 10.18 437 127614 139180 29307296
Toxicologic test abnormal 25.50 10.18 20 128031 513 29445963
Drug eruption 25.48 10.18 21 128030 16720 29429756
Hypertension 25.30 10.18 354 127697 116260 29330216
Foetal exposure during pregnancy 24.90 10.18 70 127981 33797 29412679
Headache 24.81 10.18 569 127482 173438 29273038
Pathogen resistance 24.76 10.18 3 128048 8113 29438363
Postoperative ileus 24.30 10.18 21 128030 619 29445857
Sinus tachycardia 24.20 10.18 129 127922 14940 29431536
Chronic kidney disease 24.10 10.18 79 127972 36337 29410139
Lung cancer metastatic 23.98 10.18 40 128011 2387 29444089
Herpes simplex viraemia 23.86 10.18 10 128041 71 29446405
Pulmonary haemorrhage 23.64 10.18 91 127960 9179 29437297
Self-medication 23.32 10.18 37 128014 2117 29444359
Glycosylated haemoglobin increased 23.31 10.18 6 128045 9420 29437056
Fatigue 23.11 10.18 1129 126922 315692 29130784
Spinal cord compression 22.88 10.18 49 128002 3533 29442943
Interstitial lung disease 22.87 10.18 151 127900 57567 29388909
Anaemia 22.85 10.18 679 127372 200272 29246204
Eosinophilia 22.77 10.18 38 128013 22123 29424353
Weight increased 22.76 10.18 217 127834 76450 29370026
Neuroleptic malignant syndrome 22.49 10.18 22 128029 16126 29430350
Poisoning deliberate 22.41 10.18 65 127986 5666 29440810
Sinusitis 22.40 10.18 75 127976 34275 29412201
Drug level 22.23 10.18 5 128046 0 29446476
Reaction to excipient 21.98 10.18 17 128034 427 29446049
Mydriasis 21.89 10.18 67 127984 6018 29440458
Failure to suspend medication 21.60 10.18 16 128035 376 29446100
Hypercapnia 21.57 10.18 49 128002 3677 29442799
Intestinal obstruction 21.41 10.18 150 127901 19127 29427349
Therapy interrupted 21.40 10.18 5 128046 8381 29438095
Gout 21.37 10.18 25 128026 16886 29429590
Condition aggravated 20.95 10.18 478 127573 145817 29300659
Disease progression 20.90 10.18 483 127568 81433 29365043
Medication error 20.68 10.18 160 127891 21051 29425425
Accidental poisoning 20.57 10.18 18 128033 540 29445936
Orthostatic hypotension 20.41 10.18 42 128009 22587 29423889
Angina unstable 20.06 10.18 11 128040 10854 29435622
Injection site swelling 19.75 10.18 8 128043 9409 29437067
Post procedural complication 19.54 10.18 93 127958 10296 29436180
Neurological examination abnormal 19.53 10.18 13 128038 256 29446220
Abdominal compartment syndrome 19.48 10.18 21 128030 818 29445658
Neuropathy peripheral 19.43 10.18 205 127846 70822 29375654
Sickle cell anaemia with crisis 19.41 10.18 38 128013 2570 29443906
Bladder dilatation 19.29 10.18 26 128025 1282 29445194
Bone marrow failure 19.25 10.18 58 127993 27391 29419085
Loss of personal independence in daily activities 19.13 10.18 52 127999 25388 29421088
Weaning failure 19.11 10.18 12 128039 213 29446263
Neoplasm progression 19.04 10.18 142 127909 18470 29428006
Transplant rejection 19.04 10.18 8 128043 9204 29437272
Nerve injury 18.96 10.18 41 128010 2976 29443500
Progressive multifocal leukoencephalopathy 18.96 10.18 7 128044 8712 29437764
Cerebrospinal fluid leakage 18.89 10.18 15 128036 392 29446084
Drug-induced liver injury 18.86 10.18 41 128010 21614 29424862
Secondary hypogonadism 18.80 10.18 13 128038 273 29446203
Disorientation 18.76 10.18 203 127848 29312 29417164
Hypopnoea 18.61 10.18 25 128026 1229 29445247
Muscle swelling 18.57 10.18 14 128037 338 29446138
Dyspnoea exertional 18.51 10.18 88 127963 36402 29410074
Non-small cell lung cancer 18.15 10.18 40 128011 2941 29443535
Full blood count abnormal 18.11 10.18 23 128028 14990 29431486
Hepatic enzyme increased 18.05 10.18 80 127971 33719 29412757
Tumour pain 17.97 10.18 21 128030 895 29445581
C-reactive protein increased 17.94 10.18 115 127936 44148 29402328
Rash 17.88 10.18 657 127394 189162 29257314
Apnoeic attack 17.79 10.18 13 128038 299 29446177
Patient uncooperative 17.75 10.18 14 128037 362 29446114
Myopathy 17.59 10.18 12 128039 10521 29435955
Acute myocardial infarction 17.58 10.18 130 127921 48308 29398168
Hypoglycaemia 17.42 10.18 130 127921 48216 29398260
Vein collapse 17.42 10.18 7 128044 44 29446432
Glomerular filtration rate decreased 17.31 10.18 14 128037 11252 29435224
White blood cell count decreased 17.04 10.18 256 127795 83106 29363370
Device failure 17.02 10.18 31 128020 1985 29444491
Pupil fixed 16.82 10.18 28 128023 1668 29444808
Encephalopathy 16.82 10.18 207 127844 30836 29415640
Psychotic behaviour 16.74 10.18 17 128034 617 29445859
Cluster headache 16.57 10.18 15 128036 471 29446005
Biliary obstruction 16.56 10.18 34 128017 2380 29444096
Aggression 16.34 10.18 230 127821 35311 29411165
Hypotension 16.32 10.18 1012 127039 193342 29253134
Post laminectomy syndrome 16.30 10.18 10 128041 170 29446306
Carcinoid crisis 16.12 10.18 11 128040 226 29446250
Substance dependence 16.07 10.18 13 128038 349 29446127
Salivary hypersecretion 16.02 10.18 6 128045 7403 29439073
Cerebral infarction 16.00 10.18 54 127997 24621 29421855
Visceral congestion 16.00 10.18 15 128036 493 29445983
Dependence 15.92 10.18 21 128030 1014 29445462
Fall 15.85 10.18 617 127434 176561 29269915
Transient ischaemic attack 15.73 10.18 50 128001 23220 29423256
Prescribed underdose 15.71 10.18 7 128044 7779 29438697
Accidental exposure to product by child 15.69 10.18 24 128027 1330 29445146
Vestibular disorder 15.62 10.18 21 128030 1033 29445443
Incoherent 15.61 10.18 46 128005 4046 29442430
Angina pectoris 15.43 10.18 65 127986 27785 29418691
Diabetes mellitus 15.38 10.18 105 127946 39726 29406750
Wrong technique in product usage process 15.25 10.18 77 127974 31351 29415125
Cyanosis 15.16 10.18 92 127959 11175 29435301
Drug reaction with eosinophilia and systemic symptoms 15.10 10.18 66 127985 27926 29418550
Muscle spasticity 15.05 10.18 51 128000 4832 29441644
Synovitis 14.98 10.18 15 128036 10875 29435601
Ischaemic stroke 14.97 10.18 29 128022 15948 29430528
Decerebration 14.90 10.18 5 128046 17 29446459
Photosensitivity reaction 14.86 10.18 11 128040 9247 29437229
Disease recurrence 14.81 10.18 29 128022 15885 29430591
Liver disorder 14.62 10.18 66 127985 27683 29418793
Hepatitis B 14.59 10.18 3 128048 5494 29440982
Infusion site granuloma 14.56 10.18 4 128047 5 29446471
Psoriasis 14.50 10.18 81 127970 32146 29414330
Hypertensive crisis 14.41 10.18 8 128043 7840 29438636
Liver function test 14.39 10.18 6 128045 42 29446434
Peripheral swelling 14.34 10.18 192 127859 63547 29382929
Eosinophil count increased 14.29 10.18 7 128044 7362 29439114
Immune reconstitution inflammatory syndrome 14.26 10.18 8 128043 7794 29438682
Intensive care 14.02 10.18 12 128039 349 29446127
Blood cholesterol increased 14.02 10.18 29 128022 15566 29430910
Monocytopenia 13.99 10.18 7 128044 78 29446398
Victim of homicide 13.97 10.18 8 128043 119 29446357
Postmortem blood drug level abnormal 13.96 10.18 11 128040 284 29446192
Drug intolerance 13.90 10.18 138 127913 48241 29398235
Therapy cessation 13.77 10.18 26 128025 14436 29432040
Intentional misuse of drug delivery system 13.77 10.18 4 128047 7 29446469
Injection site reaction 13.64 10.18 17 128034 11171 29435305
Allodynia 13.63 10.18 15 128036 598 29445878
Small intestinal obstruction 13.56 10.18 100 127951 12961 29433515
Diabetic ketoacidosis 13.53 10.18 31 128020 16042 29430434
Eosinophilic myocarditis 13.50 10.18 13 128038 442 29446034
Neutrophil count decreased 13.49 10.18 122 127929 43445 29403031
Medical device site bruise 13.43 10.18 4 128047 8 29446468
Back pain 13.41 10.18 556 127495 101728 29344748
Medical device site haemorrhage 13.41 10.18 8 128043 129 29446347
Opiates 13.34 10.18 3 128048 0 29446476
Arrhythmia neonatal 13.34 10.18 3 128048 0 29446476
Electrocardiogram low voltage 13.22 10.18 5 128046 26 29446450
Blood triglycerides increased 13.19 10.18 22 128029 12812 29433664
Squamous cell carcinoma of skin 13.12 10.18 13 128038 9473 29437003
Therapeutic product effect incomplete 13.09 10.18 108 127943 39197 29407279
Tooth injury 13.01 10.18 17 128034 813 29445663
C-reactive protein abnormal 13.00 10.18 6 128045 6530 29439946
Acute pulmonary oedema 12.98 10.18 61 127990 6718 29439758
Infusion site urticaria 12.91 10.18 7 128044 93 29446383
Blood pH increased 12.86 10.18 15 128036 638 29445838
Blood chromogranin A increased 12.82 10.18 9 128042 194 29446282
Platelet count decreased 12.80 10.18 350 127701 104322 29342154
Depression 12.80 10.18 276 127775 84871 29361605
Herpes zoster 12.73 10.18 77 127974 29975 29416501
Megacolon 12.70 10.18 24 128027 1581 29444895
Acute respiratory failure 12.60 10.18 172 127879 26230 29420246
Myelosuppression 12.53 10.18 21 128030 12206 29434270
Arachnoiditis 12.46 10.18 11 128040 334 29446142
End stage renal disease 12.44 10.18 9 128042 7655 29438821
Hypercholesterolaemia 12.42 10.18 8 128043 7230 29439246
Hypogammaglobulinaemia 12.42 10.18 5 128046 5902 29440574
Carcinoid tumour 12.35 10.18 9 128042 206 29446270
Pupillary reflex impaired 12.32 10.18 22 128029 1387 29445089
Swelling of eyelid 12.29 10.18 14 128037 580 29445896
Nephrotic syndrome 12.29 10.18 6 128045 6322 29440154
Multiple sclerosis relapse 12.28 10.18 19 128032 11400 29435076
Haemorrhagic stroke 12.24 10.18 5 128046 5851 29440625
Product residue present 12.13 10.18 31 128020 2508 29443968
Metastatic renal cell carcinoma 12.13 10.18 26 128025 1876 29444600
Proteinuria 12.11 10.18 32 128019 15772 29430704
Lactic acidosis 12.04 10.18 79 127972 30168 29416308
Gastrointestinal hypomotility 12.04 10.18 17 128034 876 29445600
Head injury 11.99 10.18 33 128018 16048 29430428
Thrombotic microangiopathy 11.89 10.18 12 128039 8669 29437807
Dysarthria 11.87 10.18 194 127857 30717 29415759
Foaming at mouth 11.80 10.18 15 128036 698 29445778
Disability 11.79 10.18 44 128007 4372 29442104
Ejection fraction decreased 11.76 10.18 33 128018 15945 29430531
Haemophagocytic lymphohistiocytosis 11.75 10.18 17 128034 10487 29435989
Injection site erythema 11.68 10.18 27 128024 13929 29432547
Erythema 11.68 10.18 244 127807 75362 29371114
Cor pulmonale acute 11.67 10.18 9 128042 225 29446251
Anamnestic reaction 11.64 10.18 5 128046 38 29446438
Visual impairment 11.62 10.18 78 127973 29630 29416846
Parathyroid hormone-related protein abnormal 11.62 10.18 4 128047 15 29446461
Exposure during pregnancy 11.52 10.18 12 128039 8542 29437934
Medical device site infection 11.50 10.18 9 128042 230 29446246
Hyponatraemia 11.43 10.18 215 127836 67418 29379058
Antasthmatic drug level 11.42 10.18 5 128046 40 29446436
Analgesic drug level 11.42 10.18 5 128046 40 29446436
Sitting disability 11.41 10.18 7 128044 119 29446357
Venoocclusive liver disease 11.39 10.18 8 128043 6909 29439567
Hypersensitivity 11.31 10.18 161 127890 52742 29393734
Cardiac failure chronic 11.30 10.18 7 128044 6460 29440016
Restlessness 11.28 10.18 146 127905 21999 29424477
Infantile fibromatosis 11.27 10.18 3 128048 3 29446473
Prostate cancer metastatic 11.26 10.18 47 128004 4919 29441557
Accidental underdose 11.23 10.18 11 128040 382 29446094
Intervertebral disc injury 11.23 10.18 4 128047 17 29446459
Blood pressure diastolic decreased 11.19 10.18 60 127991 6962 29439514
Obsessive-compulsive disorder 11.15 10.18 3 128048 4573 29441903
Paraparesis 11.12 10.18 24 128027 1740 29444736
Metastases to lung 11.12 10.18 65 127986 7790 29438686
Cheyne-Stokes respiration 11.11 10.18 9 128042 242 29446234
Dose calculation error 11.11 10.18 5 128046 43 29446433
Alcohol poisoning 11.10 10.18 34 128017 3055 29443421
Drug detoxification 11.10 10.18 8 128043 180 29446296
Myocardial fibrosis 11.09 10.18 18 128033 1050 29445426
Infusion related reaction 11.07 10.18 129 127922 43757 29402719
Respiration abnormal 11.07 10.18 31 128020 2649 29443827
Bronchopulmonary aspergillosis 11.06 10.18 23 128028 12321 29434155
Device computer issue 11.05 10.18 4 128047 18 29446458
Device toxicity 11.05 10.18 4 128047 18 29446458
Disease prodromal stage 11.05 10.18 4 128047 18 29446458
Respiratory rate increased 11.02 10.18 70 127981 8638 29437838
Atrial septal defect 10.99 10.18 8 128043 6781 29439695
Tuberculosis 10.98 10.18 9 128042 7187 29439289
Injection site bruising 10.94 10.18 10 128041 7570 29438906
Balance disorder 10.89 10.18 102 127949 36068 29410408
Injection site pain 10.87 10.18 89 127962 32357 29414119
Brain injury 10.85 10.18 50 128001 5462 29441014
Perineal pain 10.71 10.18 15 128036 767 29445709
Scan gallium abnormal 10.71 10.18 4 128047 20 29446456
Haematotoxicity 10.70 10.18 8 128043 6691 29439785
Injection site pruritus 10.69 10.18 6 128045 5843 29440633
Narcotic bowel syndrome 10.69 10.18 7 128044 134 29446342
Performance status decreased 10.69 10.18 38 128013 3689 29442787
Dyschezia 10.68 10.18 19 128032 1194 29445282
Palpitations 10.67 10.18 90 127961 32514 29413962
Cachexia 10.64 10.18 55 127996 6294 29440182
Electroencephalogram abnormal 10.63 10.18 28 128023 2307 29444169
Nasopharyngitis 10.61 10.18 188 127863 59477 29386999
Acute graft versus host disease 10.60 10.18 6 128045 5818 29440658
Cholestatic liver injury 10.59 10.18 23 128028 1674 29444802
Neuralgia 10.58 10.18 82 127969 10792 29435684
Pelvic pain 10.58 10.18 26 128025 2053 29444423
Vision blurred 10.56 10.18 117 127934 40059 29406417
Buttock injury 10.55 10.18 5 128046 49 29446427
Conjunctival discolouration 10.55 10.18 4 128047 21 29446455
Necrotising colitis 10.48 10.18 17 128034 991 29445485
Bradyphrenia 10.44 10.18 41 128010 4173 29442303
Kidney transplant rejection 10.40 10.18 9 128042 6996 29439480
Brain death 10.37 10.18 28 128023 2342 29444134
Bronchiectasis 10.35 10.18 8 128043 6577 29439899
Agranulocytosis 10.35 10.18 49 128002 20291 29426185
Hepatotoxicity 10.33 10.18 41 128010 17826 29428650
Tachyphylaxis 10.32 10.18 6 128045 92 29446384
Duodenal ulcer 10.29 10.18 15 128036 9223 29437253
Incorrect route of product administration 10.26 10.18 81 127970 10720 29435756
Device breakage 10.26 10.18 23 128028 1711 29444765
Faeces discoloured 10.26 10.18 27 128024 13324 29433152
Limb discomfort 10.21 10.18 16 128035 9552 29436924

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 hypersensitivity 6086.08 9.64 5983 248691 231832 64012226
Drug abuse 2227.67 9.64 2677 251997 129697 64114361
Toxicity to various agents 1977.14 9.64 4396 250278 359117 63884941
Respiratory depression 910.44 9.64 749 253925 22694 64221364
Overdose 828.26 9.64 1898 252776 157668 64086390
Accidental overdose 718.35 9.64 770 253904 32787 64211271
Death 637.49 9.64 3656 251018 479049 63765009
Respiratory arrest 602.94 9.64 886 253788 52099 64191959
Sedation 563.50 9.64 755 253919 40707 64203351
Miosis 502.80 9.64 418 254256 12848 64231210
Depressed level of consciousness 447.99 9.64 992 253682 80444 64163614
Somnolence 446.86 9.64 1788 252886 201857 64042201
Constipation 411.08 9.64 1894 252780 227443 64016615
Drug dependence 394.82 9.64 568 254106 32744 64211314
Substance abuse 365.11 9.64 299 254375 8993 64235065
Sedation complication 340.93 9.64 301 254373 10053 64234005
Cardio-respiratory arrest 338.49 9.64 1004 253670 97389 64146669
Cardiac arrest 314.24 9.64 1323 253351 152741 64091317
Unresponsive to stimuli 310.57 9.64 643 254031 49750 64194308
Completed suicide 304.93 9.64 1715 252959 222699 64021359
Bradypnoea 295.72 9.64 208 254466 4951 64239107
Drug withdrawal syndrome 288.45 9.64 475 254199 30816 64213242
Coma 269.62 9.64 860 253814 86755 64157303
Hyperaesthesia 259.94 9.64 255 254419 9759 64234299
Respiratory rate decreased 250.32 9.64 178 254496 4313 64239745
Poisoning 244.64 9.64 363 254311 21516 64222542
Off label use 239.85 9.64 1491 253183 631315 63612743
Delirium 225.59 9.64 693 253981 68501 64175557
Creatinine renal clearance decreased 221.42 9.64 279 254395 14142 64229916
Intentional product misuse 211.89 9.64 698 253976 71597 64172461
Mental status changes 208.24 9.64 622 254052 60540 64183518
Drug screen positive 199.59 9.64 172 254502 5557 64238501
Malignant neoplasm progression 197.30 9.64 926 253748 111945 64132113
Vomiting 191.58 9.64 3146 251528 547971 63696087
Confusional state 178.96 9.64 1694 252980 259450 63984608
Acute chest syndrome 177.56 9.64 82 254592 834 64243224
Blood calcium decreased 171.62 9.64 338 254336 25216 64218842
Asphyxia 167.85 9.64 198 254476 9368 64234690
Accidental death 159.37 9.64 126 254548 3599 64240459
Pulmonary oedema 158.97 9.64 674 254000 78000 64166058
Myoclonus 155.30 9.64 321 254353 24797 64219261
Drug abuser 150.93 9.64 148 254526 5660 64238398
Inadequate analgesia 145.87 9.64 123 254551 3855 64240203
Product dose omission issue 143.82 9.64 350 254324 194397 64049661
Drug ineffective 137.07 9.64 2416 252258 837831 63406227
Exposure via ingestion 136.97 9.64 130 254544 4772 64239286
Lethargy 136.03 9.64 608 254066 71986 64172072
Arthropathy 132.21 9.64 170 254504 120797 64123261
Systemic lupus erythematosus 124.59 9.64 76 254598 77536 64166522
Alopecia 121.36 9.64 299 254375 165391 64078667
Contrast media allergy 119.65 9.64 85 254589 2056 64242002
Apnoea 118.06 9.64 174 254500 10248 64233810
Arthralgia 117.44 9.64 1148 253526 441112 63802946
Hypotension 111.03 9.64 2116 252558 378858 63865200
Brain oedema 107.03 9.64 256 254418 21819 64222239
Drug diversion 102.70 9.64 61 254613 1075 64242983
Agitation 102.24 9.64 648 254026 87719 64156339
Hallucination 101.10 9.64 560 254114 72228 64171830
Pemphigus 100.88 9.64 57 254617 60644 64183414
Sinusitis 100.20 9.64 272 254402 145656 64098402
Cardiac failure congestive 96.89 9.64 234 254440 130346 64113712
Abdominal discomfort 95.42 9.64 383 254291 181939 64062119
Withdrawal syndrome 93.67 9.64 253 254421 23239 64220819
Glossodynia 93.61 9.64 71 254603 64625 64179433
Weight increased 92.11 9.64 481 254193 212867 64031191
Sleep disorder due to general medical condition, insomnia type 86.73 9.64 4 254670 26266 64217792
Headache 86.44 9.64 1521 253153 527946 63716112
Hypoxia 86.16 9.64 620 254054 87529 64156529
COVID-19 85.02 9.64 79 254595 65061 64178997
Helicobacter infection 83.29 9.64 24 254650 38338 64205720
Cognitive disorder 82.72 9.64 433 254241 54654 64189404
Fatigue 80.82 9.64 2296 252378 746434 63497624
Hand deformity 79.73 9.64 78 254596 62693 64181365
Nasopharyngitis 79.16 9.64 452 254222 195621 64048437
Sphincter of Oddi dysfunction 77.54 9.64 36 254638 371 64243687
Myalgia 76.94 9.64 343 254331 158274 64085784
Respiratory acidosis 76.90 9.64 139 254535 9716 64234342
Maternal exposure during delivery 75.82 9.64 46 254628 844 64243214
Nausea 74.03 9.64 3800 250874 782000 63462058
Hypersensitivity 73.96 9.64 463 254211 195989 64048069
Pulmonary congestion 73.93 9.64 235 254439 23645 64220413
Injection site erythema 73.77 9.64 103 254571 70697 64173361
Anti-cyclic citrullinated peptide antibody positive 73.50 9.64 53 254621 49509 64194549
Cough 73.22 9.64 801 253873 301347 63942711
Hypercapnia 72.51 9.64 118 254556 7576 64236482
Plasma cell myeloma 71.84 9.64 366 254308 45709 64198349
Muscle injury 70.95 9.64 10 254664 26427 64217631
Cytomegalovirus infection 70.86 9.64 29 254645 37170 64206888
Hepatic enzyme increased 70.50 9.64 269 254405 129674 64114384
Device expulsion 70.49 9.64 3 254671 21133 64222925
Myocardial infarction 69.24 9.64 378 254296 165443 64078615
Pericarditis 69.17 9.64 87 254587 62429 64181629
Urinary retention 68.62 9.64 379 254295 48822 64195236
Orthostatic hypotension 67.86 9.64 364 254310 46374 64197684
Duodenal ulcer perforation 67.59 9.64 26 254648 34599 64209459
Condition aggravated 67.20 9.64 1050 253624 371376 63872682
Joint swelling 66.74 9.64 537 254137 214845 64029213
Oxygen saturation decreased 66.30 9.64 681 253993 106495 64137563
Dizziness 65.03 9.64 1252 253422 428911 63815147
Exposure to toxic agent 64.31 9.64 99 254575 6060 64237998
Drug resistance 64.26 9.64 29 254645 35073 64208985
Intestinal pseudo-obstruction 63.57 9.64 57 254617 1943 64242115
Folliculitis 63.15 9.64 20 254654 30057 64214001
Poisoning deliberate 63.02 9.64 154 254520 13304 64230754
Injection site reaction 62.79 9.64 55 254619 46609 64197449
Peripheral swelling 60.95 9.64 530 254144 208623 64035435
Irritable bowel syndrome 60.79 9.64 36 254638 37333 64206725
Injection site swelling 60.31 9.64 45 254629 41308 64202750
Injection site pain 60.19 9.64 231 254443 111177 64132881
Injection site pruritus 59.37 9.64 38 254636 37788 64206270
Aspiration 58.65 9.64 173 254501 16712 64227346
Syncope 58.55 9.64 373 254301 157262 64086796
Toxicologic test abnormal 57.99 9.64 44 254630 1181 64242877
Gastrointestinal disorder 56.59 9.64 174 254500 89535 64154523
Contraindicated product administered 56.07 9.64 227 254447 107602 64136456
Acidosis 54.98 9.64 175 254499 17620 64226438
Accidental exposure to product by child 54.87 9.64 58 254616 2427 64241631
Anterior spinal artery syndrome 54.45 9.64 19 254655 84 64243974
Hypogonadism male 53.18 9.64 20 254654 114 64243944
Balance disorder 51.29 9.64 532 254142 83394 64160664
Post procedural complication 51.17 9.64 193 254481 21160 64222898
Hypoventilation 51.11 9.64 88 254586 5918 64238140
Infusion related reaction 50.96 9.64 410 254264 164057 64080001
Synovitis 50.65 9.64 210 254464 98880 64145178
Basal cell carcinoma 49.75 9.64 30 254644 30808 64213250
Respiratory failure 49.48 9.64 903 253771 160280 64083778
Dilatation intrahepatic duct acquired 49.39 9.64 32 254642 662 64243396
Diarrhoea 49.20 9.64 2343 252331 720361 63523697
Visceral congestion 49.12 9.64 34 254640 788 64243270
Loss of personal independence in daily activities 49.00 9.64 136 254538 72318 64171740
Opiates positive 48.68 9.64 35 254639 863 64243195
Hypoxic-ischaemic encephalopathy 48.50 9.64 95 254579 7057 64237001
Coronary artery disease 48.29 9.64 104 254570 60329 64183729
Ill-defined disorder 46.98 9.64 63 254611 43989 64200069
Product use in unapproved indication 46.92 9.64 458 254216 176160 64067898
Treatment failure 46.73 9.64 270 254404 116546 64127512
Red blood cell sedimentation rate abnormal 46.61 9.64 5 254669 16301 64227757
Respiratory distress 45.99 9.64 359 254315 51972 64192086
Cerebrovascular accident 45.90 9.64 336 254338 137247 64106811
Swelling 45.77 9.64 408 254266 159810 64084248
Drug tolerance 45.17 9.64 84 254590 6001 64238057
Musculoskeletal stiffness 45.00 9.64 293 254381 122913 64121145
Blood pH decreased 44.90 9.64 70 254604 4332 64239726
Contusion 44.21 9.64 266 254408 113699 64130359
Abortion spontaneous 44.14 9.64 22 254652 25121 64218937
Narcotic bowel syndrome 43.88 9.64 21 254653 233 64243825
Sopor 43.61 9.64 32 254642 29629 64214429
Hyperhidrosis 43.43 9.64 714 253960 124206 64119852
Cyanosis 43.33 9.64 188 254486 21967 64222091
Spinal cord compression 42.68 9.64 79 254595 5624 64238434
Cancer pain 42.46 9.64 67 254607 4190 64239868
Encephalopathy 42.40 9.64 386 254288 58433 64185625
Therapeutic product effect decreased 42.29 9.64 274 254400 115077 64128981
Nasal congestion 41.83 9.64 110 254564 59548 64184510
Serotonin syndrome 41.72 9.64 282 254392 39000 64205058
Wrong technique in product usage process 41.71 9.64 125 254549 64849 64179209
Dyspnoea exertional 41.70 9.64 150 254524 73580 64170478
Erythema 40.59 9.64 508 254166 186562 64057496
Wound 40.39 9.64 160 254514 76317 64167741
Dyspnoea 40.02 9.64 2377 252297 716297 63527761
Rash 39.49 9.64 1447 253227 457102 63786956
Neutropenia 39.40 9.64 687 253987 238937 64005121
Hospitalisation 38.67 9.64 159 254515 75048 64169010
Progressive multifocal leukoencephalopathy 38.50 9.64 12 254662 18220 64225838
Lung cancer metastatic 37.86 9.64 54 254620 3086 64240972
Transplant rejection 37.56 9.64 11 254663 17390 64226668
Interstitial lung disease 37.44 9.64 229 254445 97503 64146555
Rheumatoid factor positive 37.22 9.64 50 254624 34888 64209170
Drug eruption 37.21 9.64 53 254621 36083 64207975
Haematochezia 36.89 9.64 136 254538 66237 64177821
C-reactive protein abnormal 35.85 9.64 37 254637 29010 64215048
Pupillary reflex impaired 35.81 9.64 52 254622 3021 64241037
Allodynia 35.80 9.64 34 254640 1249 64242809
Self-medication 35.62 9.64 61 254613 4084 64239974
Pregnancy 35.52 9.64 19 254655 20846 64223212
Pupil fixed 35.23 9.64 53 254621 3179 64240879
Patient uncooperative 35.17 9.64 24 254650 543 64243515
Mobility decreased 33.77 9.64 501 254173 85339 64158719
Hepatic function abnormal 33.67 9.64 135 254539 64178 64179880
Rheumatoid nodule 33.45 9.64 5 254669 12646 64231412
Postoperative ileus 33.26 9.64 29 254645 952 64243106
Mydriasis 33.12 9.64 134 254540 15178 64228880
Sinus tachycardia 32.95 9.64 229 254445 31959 64212099
Transient ischaemic attack 32.89 9.64 79 254595 44103 64199955
Diaphragmatic spasm 32.69 9.64 13 254661 88 64243970
Disease progression 32.68 9.64 761 253913 140919 64103139
Drug use disorder 32.41 9.64 73 254601 5981 64238077
Full blood count abnormal 32.30 9.64 42 254632 29715 64214343
Tubulointerstitial nephritis 32.16 9.64 45 254629 30864 64213194
Aggression 32.11 9.64 301 254373 45931 64198127
Soft tissue disorder 31.90 9.64 51 254623 3225 64240833
Impaired healing 31.62 9.64 127 254547 60346 64183712
Therapy interrupted 31.62 9.64 20 254654 20016 64224042
Melaena 31.58 9.64 107 254567 53441 64190617
Disorientation 31.36 9.64 348 254326 55480 64188578
Small intestinal obstruction 31.15 9.64 179 254495 23394 64220664
Tendonitis 30.98 9.64 21 254653 20261 64223797
Neutropenic sepsis 30.94 9.64 177 254497 23095 64220963
Metastases to bone 30.92 9.64 161 254513 20274 64223784
Weaning failure 30.78 9.64 23 254651 603 64243455
Stupor 30.35 9.64 71 254603 5964 64238094
Multiple sclerosis relapse 30.26 9.64 74 254600 41061 64202997
Pneumonia aspiration 29.96 9.64 362 254312 58909 64185149
Cardiac failure 29.63 9.64 357 254317 132016 64112042
Bone marrow failure 29.53 9.64 94 254580 47858 64196200
Obliterative bronchiolitis 29.47 9.64 44 254630 2621 64241437
Therapy cessation 29.34 9.64 52 254622 32437 64211621
Blister 29.33 9.64 193 254481 80774 64163284
Tonsillar disorder 28.83 9.64 27 254647 974 64243084
Myopathy 28.80 9.64 17 254657 17663 64226395
Medication error 28.77 9.64 313 254361 49653 64194405
Impaired work ability 28.77 9.64 12 254662 15207 64228851
Intestinal obstruction 28.67 9.64 243 254431 36043 64208015
Atrial fibrillation 28.59 9.64 489 254185 170600 64073458
Tenosynovitis 28.41 9.64 6 254668 11827 64232231
Pancreatic fibrosis 28.37 9.64 12 254662 97 64243961
Granulocytopenia 27.89 9.64 4 254670 10436 64233622
Carcinoid tumour 27.88 9.64 19 254655 429 64243629
Breakthrough pain 27.88 9.64 29 254645 1191 64242867
Incoherent 27.71 9.64 76 254598 7042 64237016
Asthma 27.40 9.64 242 254432 94983 64149075
Non-small cell lung cancer 27.34 9.64 60 254614 4830 64239228
Eye pain 27.33 9.64 52 254622 31573 64212485
Implant site extravasation 27.22 9.64 23 254651 723 64243335
Neoplasm progression 27.11 9.64 264 254410 40700 64203358
Faecal volume decreased 27.10 9.64 13 254661 145 64243913
Injection site bruising 27.10 9.64 65 254609 36308 64207750
Maternal exposure during pregnancy 27.01 9.64 245 254429 95639 64148419
Immune reconstitution inflammatory syndrome 26.70 9.64 8 254666 12462 64231596
Ischaemic stroke 26.65 9.64 46 254628 28989 64215069
Chronic kidney disease 26.43 9.64 128 254546 57791 64186267
Intentional product use issue 26.28 9.64 245 254429 95119 64148939
Skin candida 26.22 9.64 33 254641 1670 64242388
Product use issue 25.88 9.64 432 254242 151283 64092775
Vascular resistance systemic decreased 25.67 9.64 14 254660 208 64243850
Sepsis neonatal 25.57 9.64 9 254665 41 64244017
Calcium deficiency 25.39 9.64 22 254652 716 64243342
Carcinoid crisis 25.31 9.64 18 254656 436 64243622
PCO2 increased 25.19 9.64 32 254642 1635 64242423
Pathogen resistance 25.18 9.64 9 254665 12534 64231524
Hypertension 25.08 9.64 806 253868 258455 63985603
Myocardial fibrosis 24.94 9.64 31 254643 1549 64242509
Sternal fracture 24.71 9.64 37 254637 2210 64241848
Intentional self-injury 24.02 9.64 49 254625 28995 64215063
Drug withdrawal syndrome neonatal 24.01 9.64 14 254660 238 64243820
Gallbladder cholesterolosis 23.99 9.64 19 254655 544 64243514
Renal impairment 23.83 9.64 382 254292 134635 64109423
Herpes simplex viraemia 23.76 9.64 14 254660 243 64243815
Blood glucose increased 23.70 9.64 260 254414 97813 64146245
Product name confusion 23.68 9.64 12 254662 152 64243906
Neurological examination abnormal 23.25 9.64 18 254656 498 64243560
Fluid retention 23.17 9.64 139 254535 59467 64184591
Throat irritation 23.17 9.64 60 254614 32651 64211407
Parkinsonism 23.16 9.64 14 254660 14359 64229699
Injection site rash 23.12 9.64 17 254657 15725 64228333
Drug-induced liver injury 23.09 9.64 103 254571 47540 64196518
Occupational dermatitis 23.07 9.64 11 254663 121 64243937
Tumour pain 22.95 9.64 33 254641 1900 64242158
Sickle cell anaemia with crisis 22.85 9.64 59 254615 5273 64238785
Sepsis 22.76 9.64 1120 253554 229221 64014837
Pain in extremity 22.66 9.64 972 253702 302113 63941945
Cholestasis 22.65 9.64 274 254400 44598 64199460
Neuralgia 22.65 9.64 179 254495 26005 64218053
Drug level 22.62 9.64 6 254668 7 64244051
Systemic mastocytosis 22.56 9.64 14 254660 268 64243790
Palpitations 22.55 9.64 284 254390 104204 64139854
Buttock injury 22.38 9.64 11 254663 130 64243928
Hallucination, visual 22.31 9.64 187 254487 27647 64216411
Eczema 22.23 9.64 53 254621 29667 64214391
Bronchitis 22.20 9.64 299 254375 108444 64135614
Infusion site granuloma 22.18 9.64 6 254668 8 64244050
PO2 decreased 22.11 9.64 39 254635 2674 64241384
White blood cell count decreased 22.09 9.64 465 254209 157372 64086686
Heavy menstrual bleeding 22.07 9.64 10 254664 12067 64231991
Neuropathy peripheral 21.93 9.64 329 254345 117196 64126862
Eosinophilia 21.83 9.64 77 254597 37999 64206059
Apnoeic attack 21.65 9.64 18 254656 553 64243505
Myelosuppression 21.65 9.64 38 254636 23792 64220266
Liver disorder 21.49 9.64 123 254551 53228 64190830
Gout 21.46 9.64 32 254642 21381 64222677
Implant site discharge 21.46 9.64 11 254663 143 64243915
Rash pruritic 21.21 9.64 136 254538 57268 64186790
Infective pulmonary exacerbation of cystic fibrosis 21.19 9.64 10 254664 11786 64232272
Hypopnoea 21.14 9.64 42 254632 3152 64240906
Schizophrenia 20.80 9.64 9 254665 11159 64232899
Salivary hypersecretion 20.66 9.64 11 254663 12102 64231956
Pulseless electrical activity 20.42 9.64 102 254572 12637 64231421
Respiratory rate increased 20.31 9.64 133 254541 18198 64225860
Glycosylated haemoglobin increased 20.23 9.64 20 254654 15999 64228059
Failure to suspend medication 20.18 9.64 15 254659 390 64243668
Aspergillus infection 20.06 9.64 21 254653 16358 64227700
Victim of homicide 20.02 9.64 11 254663 166 64243892
Haematuria 20 9.64 148 254526 60323 64183735
Prescribed underdose 20.00 9.64 25 254649 17990 64226068
Diabetes mellitus 19.98 9.64 167 254507 66307 64177751
Iron deficiency anaemia 19.80 9.64 35 254639 21854 64222204
Discomfort 19.70 9.64 214 254460 80664 64163394
Anaesthetic complication 19.65 9.64 36 254638 2543 64241515
Cerebrospinal fluid leakage 19.53 9.64 25 254649 1287 64242771
Duodenal ulcer 19.43 9.64 17 254657 14418 64229640
Administration site induration 19.24 9.64 6 254668 17 64244041
Administration site abscess 19.24 9.64 6 254668 17 64244041
Alveolitis 19.19 9.64 44 254630 3648 64240410
Blood pH increased 19.17 9.64 24 254650 1208 64242850
Pemphigoid 19.10 9.64 14 254660 12972 64231086
Splenic injury 19.10 9.64 12 254662 235 64243823
Pneumonia viral 18.99 9.64 71 254603 7751 64236307
Epstein-Barr virus infection 18.98 9.64 13 254661 12475 64231583
Hepatocellular injury 18.97 9.64 267 254407 44968 64199090
Femur fracture 18.93 9.64 70 254604 34065 64209993
Incorrect route of product administration 18.92 9.64 157 254517 23141 64220917
Haematotoxicity 18.85 9.64 14 254660 12882 64231176
Agonal death struggle 18.77 9.64 5 254669 6 64244052
Iodine allergy 18.69 9.64 16 254658 512 64243546
Gastrooesophageal reflux disease 18.69 9.64 224 254450 82919 64161139
Thrombotic microangiopathy 18.60 9.64 23 254651 16632 64227426
Pneumocystis jirovecii pneumonia 18.58 9.64 52 254622 27582 64216476
Hypercholesterolaemia 18.50 9.64 20 254654 15353 64228705
Hyponatraemia 18.49 9.64 445 254229 147894 64096164
Low density lipoprotein increased 18.43 9.64 4 254670 7736 64236322
Drug tolerance increased 18.37 9.64 17 254657 604 64243454
Retinitis 18.34 9.64 31 254643 2054 64242004
Administration site haemorrhage 18.31 9.64 7 254667 42 64244016
Visual acuity reduced 18.30 9.64 51 254623 27090 64216968
Blood cholesterol increased 18.30 9.64 119 254555 49947 64194111
Device difficult to use 18.08 9.64 8 254666 9790 64234268
Pathological fracture 18.06 9.64 77 254597 8928 64235130
Cushingoid 17.96 9.64 4 254670 7599 64236459
Haemophagocytic lymphohistiocytosis 17.96 9.64 26 254648 17583 64226475
Hypoacusis 17.90 9.64 48 254626 25819 64218239
Biliary obstruction 17.86 9.64 44 254630 3820 64240238
Intensive care 17.82 9.64 17 254657 628 64243430
Substance dependence 17.66 9.64 15 254659 475 64243583
Muscle twitching 17.62 9.64 132 254542 18866 64225192
Device failure 17.60 9.64 56 254618 5636 64238422
Anaesthesia 17.55 9.64 14 254660 405 64243653
Accidental poisoning 17.54 9.64 25 254649 1428 64242630
Administration site discharge 17.48 9.64 6 254668 25 64244033
Acute graft versus host disease in skin 17.47 9.64 3 254671 6852 64237206
Inflammation 17.46 9.64 169 254505 65131 64178927
Medical device site infection 17.44 9.64 14 254660 409 64243649
Type 2 diabetes mellitus 17.44 9.64 72 254602 33948 64210110
Acute graft versus host disease 17.43 9.64 7 254667 9077 64234981
Retrograde amnesia 17.42 9.64 15 254659 484 64243574
Photosensitivity reaction 17.41 9.64 28 254646 18145 64225913
Lymphocyte count decreased 17.40 9.64 92 254582 40607 64203451
Gangrene 17.31 9.64 66 254608 7272 64236786
Administration site odour 17.29 9.64 6 254668 26 64244032
Neuroendocrine tumour of the lung 17.29 9.64 6 254668 26 64244032
Urinary tract infection 17.24 9.64 743 253931 230853 64013205
Postmortem blood drug level increased 17.23 9.64 18 254656 743 64243315
Myelodysplastic syndrome 17.03 9.64 54 254620 27525 64216533
Diffuse axonal injury 16.94 9.64 8 254666 86 64243972
Renal disorder 16.81 9.64 77 254597 35288 64208770
Panniculitis 16.78 9.64 7 254667 8872 64235186
Pulmonary tuberculosis 16.74 9.64 4 254670 7240 64236818
Reaction to excipient 16.73 9.64 24 254650 1379 64242679
Metastasis 16.68 9.64 55 254619 5640 64238418
Hepatitis B 16.53 9.64 5 254669 7740 64236318
Anaphylactic reaction 16.50 9.64 371 254303 68293 64175765
Osteoarthritis 16.48 9.64 165 254509 63171 64180887
Restlessness 16.35 9.64 234 254440 39551 64204507
Toxic leukoencephalopathy 16.15 9.64 19 254655 896 64243162
Device computer issue 16.13 9.64 6 254668 33 64244025
Blood alkaline phosphatase increased 16.11 9.64 312 254362 55967 64188091
Enthesopathy 16.08 9.64 9 254665 9629 64234429
Body temperature increased 16.02 9.64 218 254456 36448 64207610
Squamous cell carcinoma of skin 15.97 9.64 14 254660 11862 64232196
Disease recurrence 15.95 9.64 67 254607 31443 64212615
Nephrotic syndrome 15.87 9.64 9 254665 9558 64234500
Spinal epidural haemorrhage 15.86 9.64 9 254665 145 64243913
Head discomfort 15.86 9.64 14 254660 11820 64232238
Hallucination, tactile 15.82 9.64 14 254660 469 64243589
Cerebral infarction 15.80 9.64 96 254578 40948 64203110
Central nervous system injury 15.75 9.64 9 254665 147 64243911
Acute respiratory failure 15.74 9.64 281 254393 49653 64194405
Abdominal pain 15.72 9.64 1435 253239 310940 63933118
Tuberculosis 15.65 9.64 17 254657 13021 64231037
Injection site cyst 15.62 9.64 7 254667 66 64243992
Angina unstable 15.61 9.64 23 254651 15444 64228614
Dose calculation error 15.59 9.64 9 254665 150 64243908
Asthenia 15.52 9.64 1467 253207 426577 63817481
Clonus 15.51 9.64 56 254618 6011 64238047
Wrong product administered 15.47 9.64 66 254608 7654 64236404
Vision blurred 15.45 9.64 257 254417 90059 64153999
Intentional misuse of drug delivery system 15.40 9.64 4 254670 4 64244054
Psoriatic arthropathy 15.25 9.64 104 254570 43177 64200881
Hip arthroplasty 15.25 9.64 39 254635 21312 64222746
Secondary hypogonadism 15.08 9.64 12 254662 346 64243712
Mitral valve incompetence 15.08 9.64 51 254623 25487 64218571
Dependence 15.07 9.64 29 254645 2126 64241932
Pulmonary haemorrhage 15.07 9.64 96 254578 13013 64231045
Metastases to eye 15.06 9.64 10 254664 216 64243842
Jaundice 14.98 9.64 121 254553 48391 64195667
Thymus disorder 14.94 9.64 10 254664 219 64243839
Transplant dysfunction 14.93 9.64 4 254670 6704 64237354
Paradoxical drug reaction 14.91 9.64 3 254671 6117 64237941
Oropharyngeal pain 14.83 9.64 254 254420 88613 64155445
Anaemia 14.71 9.64 1291 253383 377389 63866669
Neuroleptic malignant syndrome 14.70 9.64 50 254624 24946 64219112
Product quality issue 14.70 9.64 64 254610 29735 64214323
Dehydration 14.69 9.64 1019 253655 215744 64028314
Joint effusion 14.64 9.64 19 254655 13454 64230604
Squamous cell carcinoma 14.62 9.64 20 254654 13849 64230209
Soft tissue injury 14.59 9.64 24 254650 1555 64242503
Internal haemorrhage 14.56 9.64 6 254668 7661 64236397
Cardiac output decreased 14.54 9.64 25 254649 1679 64242379
Depression 14.49 9.64 584 254090 182707 64061351
Acute myocardial infarction 14.48 9.64 191 254483 69527 64174531
Back pain 14.43 9.64 1161 253513 249010 63995048
PO2 abnormal 14.35 9.64 5 254669 22 64244036
Red blood cell count decreased 14.34 9.64 122 254552 48264 64195794
Peripheral nerve injury 14.32 9.64 15 254659 621 64243437
Blood chromogranin A increased 14.31 9.64 12 254662 373 64243685
Surgery 14.28 9.64 60 254614 28153 64215905
Limb discomfort 14.25 9.64 57 254617 27118 64216940
Gastrointestinal hypomotility 14.24 9.64 25 254649 1708 64242350
Suicide attempt 14.22 9.64 196 254478 70811 64173247
Platelet count decreased 14.21 9.64 530 254144 167181 64076877
Hyperlipidaemia 14.17 9.64 45 254629 22931 64221127
Stomatitis 14.15 9.64 327 254347 109278 64134780
Megacolon 14.15 9.64 35 254639 3047 64241011
Breast cancer metastatic 14.14 9.64 61 254613 7108 64236950
Breast cancer 14.13 9.64 63 254611 29085 64214973
Epidural analgesia 14.13 9.64 6 254668 49 64244009
Increased bronchial secretion 13.82 9.64 33 254641 2809 64241249
Spinal cord injury 13.82 9.64 18 254656 943 64243115
Alanine aminotransferase abnormal 13.73 9.64 5 254669 6883 64237175
Colitis microscopic 13.72 9.64 62 254612 7370 64236688
Basal ganglion degeneration 13.71 9.64 12 254662 396 64243662
Sinus congestion 13.68 9.64 25 254649 15414 64228644
Myoglobin urine 13.67 9.64 5 254669 26 64244032
Opiates 13.62 9.64 3 254671 0 64244058
Femoral pulse abnormal 13.62 9.64 3 254671 0 64244058
Demyelination 13.56 9.64 5 254669 6829 64237229
Fibrinolysis 13.44 9.64 6 254668 56 64244002
Nodule 13.43 9.64 32 254642 17915 64226143
Erythema multiforme 13.41 9.64 26 254648 15675 64228383
Antinuclear antibody positive 13.40 9.64 4 254670 6246 64237812
Hostility 13.40 9.64 28 254646 2179 64241879
Proteinuria 13.39 9.64 60 254614 27663 64216395
Cystitis 13.38 9.64 106 254568 42569 64201489
Arachnoiditis 13.33 9.64 15 254659 674 64243384
End stage renal disease 13.32 9.64 13 254661 10462 64233596
Needle issue 13.31 9.64 72 254602 9200 64234858
Knee arthroplasty 13.31 9.64 58 254616 26941 64217117
Hypertensive crisis 13.29 9.64 33 254641 18215 64225843
Performance status decreased 13.28 9.64 49 254625 5315 64238743
Lactic acidosis 13.21 9.64 167 254507 61243 64182815
Blood phosphorus decreased 13.20 9.64 51 254623 5654 64238404
Cardiac failure acute 13.16 9.64 28 254646 16316 64227742
Exercise tolerance decreased 13.15 9.64 7 254667 7703 64236355
Therapeutic response decreased 13.15 9.64 137 254537 52051 64192007
Gastrointestinal haemorrhage 13.10 9.64 410 254264 131902 64112156
Kidney transplant rejection 13.05 9.64 11 254663 9500 64234558
Diabetes mellitus inadequate control 12.99 9.64 42 254632 21279 64222779
Rhythm idioventricular 12.98 9.64 13 254661 510 64243548
Cardiac failure chronic 12.98 9.64 10 254664 9031 64235027
Optic neuritis 12.95 9.64 8 254666 8108 64235950
Stroke volume increased 12.91 9.64 4 254670 11 64244047
Skin cancer 12.89 9.64 17 254657 11957 64232101
Genital haemorrhage 12.85 9.64 3 254671 5519 64238539
Hypogammaglobulinaemia 12.84 9.64 13 254661 10286 64233772
Paraplegia 12.83 9.64 43 254631 4447 64239611
Anamnestic reaction 12.81 9.64 5 254669 32 64244026
Electrocardiogram low voltage 12.81 9.64 5 254669 32 64244026
Injection site induration 12.67 9.64 10 254664 8922 64235136
Insomnia 12.66 9.64 645 254029 197191 64046867
Septic necrosis 12.66 9.64 4 254670 12 64244046
Injection site warmth 12.65 9.64 21 254653 13441 64230617
Product monitoring error 12.62 9.64 3 254671 5451 64238607
Feeling jittery 12.62 9.64 14 254660 10621 64233437
Nervous system disorder 12.57 9.64 143 254531 22935 64221123
Pulse absent 12.53 9.64 69 254605 8877 64235181
Delayed recovery from anaesthesia 12.50 9.64 22 254652 1506 64242552
Substance use 12.50 9.64 14 254660 626 64243432
Vascular malformation 12.46 9.64 10 254664 292 64243766
Polyarthritis 12.42 9.64 12 254662 9703 64234355
Ileus 12.37 9.64 142 254532 22824 64221234
Infection 12.36 9.64 600 254074 184280 64059778
Eosinophilic myocarditis 12.32 9.64 16 254658 836 64243222
Product storage error 12.31 9.64 21 254653 13297 64230761
Cluster headache 12.30 9.64 16 254658 837 64243221
Tachycardia 12.30 9.64 715 253959 148864 64095194
Paraparesis 12.28 9.64 36 254638 3466 64240592
Theft 12.27 9.64 9 254665 229 64243829
Pituitary apoplexy 12.20 9.64 8 254666 169 64243889
Chest discomfort 12.18 9.64 357 254317 115749 64128309
Cardiomyopathy 12.18 9.64 55 254619 25301 64218757
Suicidal ideation 12.16 9.64 187 254487 66355 64177703
Injection site discolouration 12.09 9.64 6 254668 6869 64237189
Pocket erosion 12.08 9.64 5 254669 38 64244020
Epidural haemorrhage 12.08 9.64 8 254666 172 64243886
Large intestine polyp 12.07 9.64 15 254659 10822 64233236
Nephrosclerosis 12.06 9.64 22 254652 1549 64242509
Bronchopulmonary aspergillosis 12.04 9.64 37 254637 19048 64225010
Dysphonia 12.00 9.64 121 254553 46261 64197797
Parathyroid hormone-related protein abnormal 11.98 9.64 4 254670 15 64244043
Coronary artery bypass 11.97 9.64 4 254670 5811 64238247
Agranulocytosis 11.96 9.64 95 254579 38134 64205924
Sleep disorder due to a general medical condition 11.95 9.64 9 254665 8225 64235833
Cataract 11.95 9.64 137 254537 51125 64192933
Antasthmatic drug level 11.86 9.64 5 254669 40 64244018
Cardiac murmur 11.86 9.64 17 254657 11546 64232512
Immunosuppressant drug level increased 11.80 9.64 7 254667 7252 64236806
Onychomycosis 11.75 9.64 3 254671 5193 64238865
Leukopenia 11.72 9.64 307 254367 100935 64143123
Stridor 11.63 9.64 44 254630 4830 64239228
Tissue infiltration 11.63 9.64 13 254661 580 64243478
Haemorrhage 11.62 9.64 232 254442 79119 64164939
Blood triglycerides increased 11.60 9.64 37 254637 18829 64225229
Analgesic therapy 11.55 9.64 3 254671 3 64244055
Inappropriate antidiuretic hormone secretion 11.53 9.64 47 254627 22242 64221816
Cardiac output increased 11.50 9.64 8 254666 187 64243871
Malignant melanoma 11.48 9.64 21 254653 12943 64231115
Drug reaction with eosinophilia and systemic symptoms 11.46 9.64 148 254526 54069 64189989
Analgesic drug level 11.45 9.64 5 254669 44 64244014
Lymphoproliferative disorder 11.44 9.64 3 254671 5100 64238958
Excessive eye blinking 11.44 9.64 19 254655 1241 64242817
Device toxicity 11.41 9.64 4 254670 18 64244040
Dyspepsia 11.41 9.64 236 254438 80076 64163982
Psychotic behaviour 11.40 9.64 17 254657 1012 64243046
Intercepted product dispensing error 11.37 9.64 7 254667 132 64243926
Large intestine perforation 11.36 9.64 87 254587 12517 64231541
Spinal cord paralysis 11.32 9.64 7 254667 133 64243925
Paranasal cyst 11.32 9.64 10 254664 334 64243724
Influenza 11.31 9.64 327 254347 106204 64137854
Alkalosis 11.23 9.64 11 254663 420 64243638
Libido increased 11.21 9.64 23 254651 1767 64242291
Foetal monitoring abnormal 11.19 9.64 7 254667 136 64243922
Cardiac pacemaker insertion 11.17 9.64 3 254671 5020 64239038
Analgesic drug level above therapeutic 11.17 9.64 11 254663 423 64243635
Toxic skin eruption 11.05 9.64 39 254635 19245 64224813
Red blood cell sedimentation rate increased 11.03 9.64 75 254599 31160 64212898
Gastric dilatation 11.01 9.64 18 254656 1160 64242898
Muscle swelling 11.01 9.64 14 254660 716 64243342
Abdominal compartment syndrome 10.96 9.64 20 254654 1408 64242650
Snoring 10.95 9.64 42 254632 4640 64239418
Hyperthyroidism 10.94 9.64 36 254638 18143 64225915
Polyneuropathy 10.90 9.64 41 254633 19853 64224205
Fear-related avoidance of activities 10.89 9.64 6 254668 91 64243967
Brain death 10.88 9.64 43 254631 4818 64239240
Aplastic anaemia 10.88 9.64 93 254581 13827 64230231
Device use error 10.86 9.64 6 254668 6465 64237593
Haemorrhagic stroke 10.85 9.64 14 254660 9937 64234121
Cardiac disorder 10.84 9.64 155 254519 55661 64188397
Abdominal pain upper 10.75 9.64 573 254101 174457 64069601
Dysarthria 10.74 9.64 309 254365 59097 64184961
Blood pressure diastolic increased 10.71 9.64 76 254598 10676 64233382
Viral upper respiratory tract infection 10.67 9.64 10 254664 8205 64235853
Bladder dilatation 10.65 9.64 23 254651 1831 64242227
Sitting disability 10.63 9.64 7 254667 149 64243909
Leukoencephalopathy 10.62 9.64 55 254619 6912 64237146
Nerve injury 10.58 9.64 59 254615 7626 64236432
Monocytopenia 10.55 9.64 7 254667 151 64243907
Labelled drug-drug interaction medication error 10.51 9.64 48 254626 22014 64222044
Metastases to spine 10.51 9.64 35 254639 3608 64240450
Laboratory test abnormal 10.51 9.64 54 254620 24009 64220049
Catheter site phlebitis 10.47 9.64 4 254670 24 64244034
Mastoid disorder 10.47 9.64 4 254670 24 64244034
Pulmonary toxicity 10.46 9.64 11 254663 8550 64235508
Faecaloma 10.42 9.64 70 254604 9658 64234400
Accident 10.40 9.64 54 254620 6792 64237266
Foetal megacystis 10.34 9.64 3 254671 6 64244052
Scan gallium abnormal 10.33 9.64 4 254670 25 64244033
Urine alcohol test positive 10.33 9.64 4 254670 25 64244033
Perineal pain 10.30 9.64 16 254658 987 64243071
Hypoglycaemia 10.30 9.64 273 254401 89619 64154439
Chronic graft versus host disease 10.27 9.64 6 254668 6270 64237788
Psychomotor skills impaired 10.27 9.64 36 254638 3809 64240249
Pain in jaw 10.26 9.64 107 254567 40648 64203410
Post-traumatic neck syndrome 10.25 9.64 23 254651 1879 64242179
Catheter site granuloma 10.25 9.64 5 254669 58 64244000
Intrapericardial thrombosis 10.25 9.64 5 254669 58 64244000
Blood creatine phosphokinase MB increased 10.22 9.64 28 254646 2593 64241465
Blood loss anaemia 10.21 9.64 25 254649 13867 64230191
Areflexia 10.18 9.64 43 254631 4964 64239094
Mediastinal shift 10.18 9.64 5 254669 59 64243999
Cytomegalovirus infection reactivation 10.16 9.64 5 254669 5751 64238307
Neurogenic bowel 10.12 9.64 7 254667 162 64243896
Neuroblastoma 10.12 9.64 7 254667 162 64243896
Increased tendency to bruise 10.11 9.64 13 254661 9242 64234816
Head injury 10.10 9.64 82 254592 32760 64211298
Mucosal inflammation 10.10 9.64 321 254353 62263 64181795
Dyslipidaemia 10.08 9.64 13 254661 9229 64234829
Laryngectomy 10.07 9.64 4 254670 27 64244031
Electroencephalogram abnormal 10.06 9.64 44 254630 5159 64238899
Skin papilloma 10 9.64 4 254670 5199 64238859
Gastric ulcer 9.99 9.64 74 254600 30160 64213898
Cheyne-Stokes respiration 9.98 9.64 11 254663 483 64243575
Eosinophil count increased 9.90 9.64 26 254648 14086 64229972
Medical device site haemorrhage 9.90 9.64 7 254667 168 64243890
Actinic keratosis 9.88 9.64 4 254670 5161 64238897
Eye irritation 9.82 9.64 31 254643 15825 64228233
Adverse event 9.81 9.64 104 254570 39385 64204673
Hypercreatininaemia 9.80 9.64 14 254660 801 64243257
Dependence on oxygen therapy 9.79 9.64 10 254664 402 64243656
Flushing 9.77 9.64 236 254438 78412 64165646
Injection site haemorrhage 9.76 9.64 56 254618 24222 64219836
Prostate cancer metastatic 9.76 9.64 32 254642 3272 64240786
Clumsiness 9.76 9.64 28 254646 2663 64241395
Anaesthetic complication pulmonary 9.75 9.64 5 254669 65 64243993
Respiratory tract congestion 9.74 9.64 32 254642 16133 64227925
Acute pulmonary oedema 9.71 9.64 85 254589 12724 64231334
Amenorrhoea 9.68 9.64 7 254667 6532 64237526
Glomerular filtration rate decreased 9.67 9.64 42 254632 19530 64224528

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC A07DA52 ALIMENTARY TRACT AND METABOLISM
ANTIDIARRHEALS, INTESTINAL ANTIINFLAMMATORY/ANTIINFECTIVE AGENTS
ANTIPROPULSIVES
Antipropulsives
ATC N02AA01 NERVOUS SYSTEM
ANALGESICS
OPIOIDS
Natural opium alkaloids
ATC N02AA51 NERVOUS SYSTEM
ANALGESICS
OPIOIDS
Natural opium alkaloids
ATC N02AG01 NERVOUS SYSTEM
ANALGESICS
OPIOIDS
Opioids in combination with antispasmodics
ATC R05DA05 RESPIRATORY SYSTEM
COUGH AND COLD PREPARATIONS
COUGH SUPPRESSANTS, EXCL. COMBINATIONS WITH EXPECTORANTS
Opium alkaloids and derivatives
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
FDA MoA N0000175684 Full Opioid Agonists
FDA EPC N0000175690 Opioid Agonist
CHEBI has role CHEBI:35482 narcotic analgesic
CHEBI has role CHEBI:35620 vasodilator agents
CHEBI has role CHEBI:35703 Xenobiotic
CHEBI has role CHEBI:38867 anaesthetic
CHEBI has role CHEBI:55322 mu-opioid agonists
CHEBI has role CHEBI:76924 plant metabolites
CHEBI has role CHEBI:78298 environmental contaminants
CHEBI has role CHEBI:88188 allergenic drug
CHEBI has role CHEBI:176497 geroprotectors

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

DiseaseRelationSNOMED_IDDOID
Pain indication 22253000
General anesthesia indication 50697003
Diarrhea indication 62315008
Severe pain indication 76948002
Chronic pain indication 82423001
Local anesthesia indication 386761002
Acute postoperative pain indication 107401000119105
Regional Anesthesia for Surgery indication
Regional Anesthesia for Labor Pain indication
Chronic Pain with Opioid Tolerance indication
Neuropathic pain off-label use 247398009
Neonatal Abstinence Syndrome off-label use 414819007 DOID:9828
Sedation in Intubated Patients off-label use
Neonatal Opioid Dependence off-label use
Brain damage contraindication 2470005
Priapism contraindication 6273006 DOID:9286
Tachyarrhythmia contraindication 6285003
Urinary tract obstruction contraindication 7163005 DOID:5200
Alcoholism contraindication 7200002
Alcohol withdrawal delirium contraindication 8635005
Dyskinesia contraindication 9748009
Chronic obstructive lung disease contraindication 13645005 DOID:3083
Severe chronic ulcerative colitis contraindication 14311001
Chronic disease of respiratory system contraindication 17097001
Acute vomiting contraindication 23971007
Alcohol intoxication contraindication 25702006
Shock contraindication 27942005
Toxic megacolon contraindication 28536002 DOID:1770
Orthostatic hypotension contraindication 28651003
Atony of colon contraindication 29479008
Hypercapnia contraindication 29596007
Torsades de pointes contraindication 31722008
Hyperthyroidism contraindication 34486009 DOID:7998
Depressive disorder contraindication 35489007
Hypertensive disorder contraindication 38341003 DOID:10763
Disorder of gallbladder contraindication 39621005 DOID:0060262
Hypothyroidism contraindication 40930008 DOID:1459
Complete trisomy 21 syndrome contraindication 41040004 DOID:14250
Hypokalemia contraindication 43339004
Low blood pressure contraindication 45007003
Achalasia of esophagus contraindication 45564002 DOID:9164
Chronic heart failure contraindication 48447003
Paralytic ileus contraindication 55525008 DOID:8442
Peptic reflux disease contraindication 57643001
Acute nephropathy contraindication 58574008
Hepatic failure contraindication 59927004
Cerebrovascular disease contraindication 62914000 DOID:6713
Ulcerative colitis contraindication 64766004 DOID:8577
Drug AND/OR toxin-induced diarrhea contraindication 65979008
Substance abuse contraindication 66214007
Benign intracranial hypertension contraindication 68267002 DOID:11459
Psychotic disorder contraindication 69322001
Sleep apnea contraindication 73430006 DOID:0050847
Pancreatitis contraindication 75694006 DOID:4989
Urethral stricture contraindication 76618002
Spastic paralysis contraindication 78403003
Disturbance of salivary secretion contraindication 78948009
Decreased respiratory function contraindication 80954004
Injury of head contraindication 82271004
Cor pulmonale contraindication 83291003 DOID:8515
Hiatal hernia contraindication 84089009 DOID:12642
Epilepsy contraindication 84757009 DOID:1826
Kidney disease contraindication 90708001 DOID:557
Myasthenia gravis contraindication 91637004 DOID:437
Disorder of biliary tract contraindication 105997008 DOID:9741
Prolonged QT interval contraindication 111975006
Gastrointestinal obstruction contraindication 126765001
Seizure disorder contraindication 128613002
Autonomic dysreflexia contraindication 129618003
Bleeding contraindication 131148009
Hypomagnesemia contraindication 190855004
Alcohol withdrawal syndrome contraindication 191480000
Drug-induced psychosis contraindication 191483003 DOID:1742
Acute pancreatitis contraindication 197456007 DOID:2913
Impaired renal function disorder contraindication 197663003
Myocardial dysfunction contraindication 233928007
Disease of liver contraindication 235856003 DOID:409
Chronic diarrhea contraindication 236071009
Bladder outflow obstruction contraindication 236645006
Pyloric obstruction contraindication 244815007
Benign prostatic hyperplasia contraindication 266569009
Retention of urine contraindication 267064002
Drowsy contraindication 271782001
Primary adrenocortical insufficiency contraindication 373662000
Angle-closure glaucoma contraindication 392291006 DOID:13550
Gastric ulcer contraindication 397825006 DOID:10808
Chronic lung disease contraindication 413839001
Disorder of coronary artery contraindication 414024009
Central nervous system depression contraindication 418072004
Congenital long QT syndrome contraindication 442917000
Acute exacerbation of asthma contraindication 708038006
Predisposition to Nausea and Vomiting contraindication
Progressive Angina Pectoris contraindication
Severe Nausea contraindication
Pain in Opioid Naive Patients 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 9.71 acidic
pKa2 8.38 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
100MG;4MG EMBEDA ALPHARMA PHARMS N022321 Aug. 13, 2009 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
20MG;0.8MG EMBEDA ALPHARMA PHARMS N022321 Aug. 13, 2009 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
30MG;1.2MG EMBEDA ALPHARMA PHARMS N022321 Aug. 13, 2009 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
50MG;2MG EMBEDA ALPHARMA PHARMS N022321 Aug. 13, 2009 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
60MG;2.4MG EMBEDA ALPHARMA PHARMS N022321 Aug. 13, 2009 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
80MG;3.2MG EMBEDA ALPHARMA PHARMS N022321 Aug. 13, 2009 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
100MG;4MG EMBEDA ALPHARMA PHARMS N022321 Aug. 13, 2009 DISCN CAPSULE, EXTENDED RELEASE ORAL 7682633 June 19, 2027 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG TERM OPIOID TREATEMENT BY ORALLY ADMINISTERING AN INTACT COMPOSITION AS CLAIMED.
100MG;4MG EMBEDA ALPHARMA PHARMS N022321 Aug. 13, 2009 DISCN CAPSULE, EXTENDED RELEASE ORAL 8158156 June 19, 2027 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG TERM OPIOID TREATEMENT BY ORALLY ADMINISTERING AN INTACT COMPOSITION AS CLAIMED.
20MG;0.8MG EMBEDA ALPHARMA PHARMS N022321 Aug. 13, 2009 DISCN CAPSULE, EXTENDED RELEASE ORAL 7682633 June 19, 2027 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG TERM OPIOID TREATEMENT BY ORALLY ADMINISTERING AN INTACT COMPOSITION AS CLAIMED.
20MG;0.8MG EMBEDA ALPHARMA PHARMS N022321 Aug. 13, 2009 DISCN CAPSULE, EXTENDED RELEASE ORAL 8158156 June 19, 2027 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG TERM OPIOID TREATEMENT BY ORALLY ADMINISTERING AN INTACT COMPOSITION AS CLAIMED.
30MG;1.2MG EMBEDA ALPHARMA PHARMS N022321 Aug. 13, 2009 DISCN CAPSULE, EXTENDED RELEASE ORAL 7682633 June 19, 2027 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG TERM OPIOID TREATEMENT BY ORALLY ADMINISTERING AN INTACT COMPOSITION AS CLAIMED.
30MG;1.2MG EMBEDA ALPHARMA PHARMS N022321 Aug. 13, 2009 DISCN CAPSULE, EXTENDED RELEASE ORAL 8158156 June 19, 2027 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG TERM OPIOID TREATEMENT BY ORALLY ADMINISTERING AN INTACT COMPOSITION AS CLAIMED.
50MG;2MG EMBEDA ALPHARMA PHARMS N022321 Aug. 13, 2009 DISCN CAPSULE, EXTENDED RELEASE ORAL 7682633 June 19, 2027 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG TERM OPIOID TREATEMENT BY ORALLY ADMINISTERING AN INTACT COMPOSITION AS CLAIMED.
50MG;2MG EMBEDA ALPHARMA PHARMS N022321 Aug. 13, 2009 DISCN CAPSULE, EXTENDED RELEASE ORAL 8158156 June 19, 2027 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG TERM OPIOID TREATEMENT BY ORALLY ADMINISTERING AN INTACT COMPOSITION AS CLAIMED.
60MG;2.4MG EMBEDA ALPHARMA PHARMS N022321 Aug. 13, 2009 DISCN CAPSULE, EXTENDED RELEASE ORAL 7682633 June 19, 2027 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG TERM OPIOID TREATEMENT BY ORALLY ADMINISTERING AN INTACT COMPOSITION AS CLAIMED.
60MG;2.4MG EMBEDA ALPHARMA PHARMS N022321 Aug. 13, 2009 DISCN CAPSULE, EXTENDED RELEASE ORAL 8158156 June 19, 2027 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG TERM OPIOID TREATEMENT BY ORALLY ADMINISTERING AN INTACT COMPOSITION AS CLAIMED.
80MG;3.2MG EMBEDA ALPHARMA PHARMS N022321 Aug. 13, 2009 DISCN CAPSULE, EXTENDED RELEASE ORAL 7682633 June 19, 2027 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG TERM OPIOID TREATEMENT BY ORALLY ADMINISTERING AN INTACT COMPOSITION AS CLAIMED.
80MG;3.2MG EMBEDA ALPHARMA PHARMS N022321 Aug. 13, 2009 DISCN CAPSULE, EXTENDED RELEASE ORAL 8158156 June 19, 2027 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG TERM OPIOID TREATEMENT BY ORALLY ADMINISTERING AN INTACT COMPOSITION AS CLAIMED.
100MG;4MG EMBEDA ALPHARMA PHARMS N022321 Aug. 13, 2009 DISCN CAPSULE, EXTENDED RELEASE ORAL 8623418 Nov. 7, 2029 TREATMENT OF MODERATE TO SEVERE CHRONIC PAIN BY ADMINISTERING AN INTACT COMPOSITION AS CLAIMED
20MG;0.8MG EMBEDA ALPHARMA PHARMS N022321 Aug. 13, 2009 DISCN CAPSULE, EXTENDED RELEASE ORAL 8623418 Nov. 7, 2029 TREATMENT OF MODERATE TO SEVERE CHRONIC PAIN BY ADMINISTERING AN INTACT COMPOSITION AS CLAIMED
30MG;1.2MG EMBEDA ALPHARMA PHARMS N022321 Aug. 13, 2009 DISCN CAPSULE, EXTENDED RELEASE ORAL 8623418 Nov. 7, 2029 TREATMENT OF MODERATE TO SEVERE CHRONIC PAIN BY ADMINISTERING AN INTACT COMPOSITION AS CLAIMED
50MG;2MG EMBEDA ALPHARMA PHARMS N022321 Aug. 13, 2009 DISCN CAPSULE, EXTENDED RELEASE ORAL 8623418 Nov. 7, 2029 TREATMENT OF MODERATE TO SEVERE CHRONIC PAIN BY ADMINISTERING AN INTACT COMPOSITION AS CLAIMED
60MG;2.4MG EMBEDA ALPHARMA PHARMS N022321 Aug. 13, 2009 DISCN CAPSULE, EXTENDED RELEASE ORAL 8623418 Nov. 7, 2029 TREATMENT OF MODERATE TO SEVERE CHRONIC PAIN BY ADMINISTERING AN INTACT COMPOSITION AS CLAIMED
80MG;3.2MG EMBEDA ALPHARMA PHARMS N022321 Aug. 13, 2009 DISCN CAPSULE, EXTENDED RELEASE ORAL 8623418 Nov. 7, 2029 TREATMENT OF MODERATE TO SEVERE CHRONIC PAIN BY ADMINISTERING AN INTACT COMPOSITION AS CLAIMED
15MG ARYMO ER ZYLA N208603 Jan. 9, 2017 DISCN TABLET, EXTENDED RELEASE ORAL 9044402 July 1, 2033 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
15MG ARYMO ER ZYLA N208603 Jan. 9, 2017 DISCN TABLET, EXTENDED RELEASE ORAL 9549899 July 1, 2033 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
30MG ARYMO ER ZYLA N208603 Jan. 9, 2017 DISCN TABLET, EXTENDED RELEASE ORAL 9044402 July 1, 2033 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
30MG ARYMO ER ZYLA N208603 Jan. 9, 2017 DISCN TABLET, EXTENDED RELEASE ORAL 9549899 July 1, 2033 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
60MG ARYMO ER ZYLA N208603 Jan. 9, 2017 DISCN TABLET, EXTENDED RELEASE ORAL 9044402 July 1, 2033 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
60MG ARYMO ER ZYLA N208603 Jan. 9, 2017 DISCN TABLET, EXTENDED RELEASE ORAL 9549899 July 1, 2033 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
10MG/ML (10MG/ML) MORPHINE SULFATE FRESENIUS KABI USA N204223 Oct. 30, 2013 RX SOLUTION INTRAMUSCULAR, INTRAVENOUS 9192608 March 12, 2034 MANAGEMENT OF CHRONIC PAIN IN PATIENTS REQUIRING OPIOID ANALGESIA
10MG/ML (10MG/ML) MORPHINE SULFATE FRESENIUS KABI USA N204223 Oct. 30, 2013 RX SOLUTION INTRAMUSCULAR, INTRAVENOUS 9192608 March 12, 2034 TREATMENT OF PAIN
2MG/ML (2MG/ML) MORPHINE SULFATE FRESENIUS KABI USA N204223 Oct. 30, 2013 RX SOLUTION INTRAMUSCULAR, INTRAVENOUS 9192608 March 12, 2034 MANAGEMENT OF CHRONIC PAIN IN PATIENTS REQUIRING OPIOID ANALGESIA
2MG/ML (2MG/ML) MORPHINE SULFATE FRESENIUS KABI USA N204223 Oct. 30, 2013 RX SOLUTION INTRAMUSCULAR, INTRAVENOUS 9192608 March 12, 2034 TREATMENT OF PAIN
4MG/ML (4MG/ML) MORPHINE SULFATE FRESENIUS KABI USA N204223 Oct. 30, 2013 RX SOLUTION INTRAMUSCULAR, INTRAVENOUS 9192608 March 12, 2034 MANAGEMENT OF CHRONIC PAIN IN PATIENTS REQUIRING OPIOID ANALGESIA
4MG/ML (4MG/ML) MORPHINE SULFATE FRESENIUS KABI USA N204223 Oct. 30, 2013 RX SOLUTION INTRAMUSCULAR, INTRAVENOUS 9192608 March 12, 2034 TREATMENT OF PAIN
5MG/ML (5MG/ML) MORPHINE SULFATE FRESENIUS KABI USA N204223 Oct. 30, 2013 RX SOLUTION INTRAMUSCULAR, INTRAVENOUS 9192608 March 12, 2034 MANAGEMENT OF CHRONIC PAIN IN PATIENTS REQUIRING OPIOID ANALGESIA
5MG/ML (5MG/ML) MORPHINE SULFATE FRESENIUS KABI USA N204223 Oct. 30, 2013 RX SOLUTION INTRAMUSCULAR, INTRAVENOUS 9192608 March 12, 2034 TREATMENT OF PAIN
8MG/ML (8MG/ML) MORPHINE SULFATE FRESENIUS KABI USA N204223 Oct. 30, 2013 RX SOLUTION INTRAMUSCULAR, INTRAVENOUS 9192608 March 12, 2034 MANAGEMENT OF CHRONIC PAIN IN PATIENTS REQUIRING OPIOID ANALGESIA
8MG/ML (8MG/ML) MORPHINE SULFATE FRESENIUS KABI USA N204223 Oct. 30, 2013 RX SOLUTION INTRAMUSCULAR, INTRAVENOUS 9192608 March 12, 2034 TREATMENT OF PAIN

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
10MG/5ML MORPHINE SULFATE HIKMA N022195 March 17, 2008 RX SOLUTION ORAL June 2, 2024 NEW PATIENT POPULATION
20MG/5ML MORPHINE SULFATE HIKMA N022195 March 17, 2008 RX SOLUTION ORAL June 2, 2024 NEW PATIENT POPULATION
15MG MORPHINE SULFATE HIKMA N022207 March 17, 2008 RX TABLET ORAL June 2, 2024 NEW PATIENT POPULATION
30MG MORPHINE SULFATE HIKMA N022207 March 17, 2008 RX TABLET ORAL June 2, 2024 NEW PATIENT POPULATION

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Mu-type opioid receptor GPCR AGONIST EC50 7.86 WOMBAT-PK CHEMBL
Kappa-type opioid receptor GPCR Ki 6.97 WOMBAT-PK
Delta-type opioid receptor GPCR Ki 6.62 WOMBAT-PK
Solute carrier family 22 member 1 Transporter IC50 4.55 CHEMBL
Mu-type opioid receptor GPCR Ki 9.11 CHEMBL
Mu-type opioid receptor GPCR Ki 8.92 CHEMBL
Mu-type opioid receptor GPCR Ki 9.06 CHEMBL
Delta-type opioid receptor GPCR Ki 7 CHEMBL
Delta-type opioid receptor GPCR Ki 8.74 CHEMBL
Kappa-type opioid receptor GPCR Ki 7.62 CHEMBL
Kappa-type opioid receptor GPCR Ki 7.57 CHEMBL
Kappa-type opioid receptor GPCR Ki 6.52 CHEMBL
Mu-type opioid receptor GPCR Ki 9.30 CHEMBL
Nociceptin receptor GPCR Ki 7.86 CHEMBL
Opioid receptor GPCR Ki 8.22 CHEMBL
Dopamine receptor GPCR IC50 8.27 CHEMBL
Opioid receptor GPCR IC50 7.57 CHEMBL
Mu opioid receptor-like OR2 GPCR Ki 6.73 CHEMBL
Opioid receptor, delta 1b GPCR Ki 5.85 CHEMBL
Opioid receptor homologue GPCR Ki 6.65 CHEMBL

External reference:

IDSource
D00842 KEGG_DRUG
52-26-6 SECONDARY_CAS_RN
6211-15-0 SECONDARY_CAS_RN
4017470 VANDF
4017530 VANDF
C0026549 UMLSCUI
CHEBI:17303 CHEBI
MOI PDB_CHEM_ID
CHEMBL70 ChEMBL_ID
CHEMBL556578 ChEMBL_ID
DB00295 DRUGBANK_ID
CHEMBL2103744 ChEMBL_ID
CHEMBL2096625 ChEMBL_ID
D009020 MESH_DESCRIPTOR_UI
5288826 PUBCHEM_CID
1627 IUPHAR_LIGAND_ID
76I7G6D29C UNII
235751 RXNORM
15239 MMSL
18643 MMSL
1913 MMSL
5136 MMSL
d00308 MMSL
d05295 MMSL
001545 NDDF
001546 NDDF
003523 NDDF
373529000 SNOMEDCT_US
395804007 SNOMEDCT_US
60886004 SNOMEDCT_US
73572009 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Kadian HUMAN PRESCRIPTION DRUG LABEL 1 0023-6011 CAPSULE, EXTENDED RELEASE 10 mg ORAL NDA 34 sections
Kadian HUMAN PRESCRIPTION DRUG LABEL 1 0023-6012 CAPSULE, EXTENDED RELEASE 20 mg ORAL NDA 34 sections
Kadian HUMAN PRESCRIPTION DRUG LABEL 1 0023-6013 CAPSULE, EXTENDED RELEASE 30 mg ORAL NDA 34 sections
Kadian HUMAN PRESCRIPTION DRUG LABEL 1 0023-6014 CAPSULE, EXTENDED RELEASE 40 mg ORAL NDA 34 sections
Kadian HUMAN PRESCRIPTION DRUG LABEL 1 0023-6015 CAPSULE, EXTENDED RELEASE 50 mg ORAL NDA 34 sections
Kadian HUMAN PRESCRIPTION DRUG LABEL 1 0023-6016 CAPSULE, EXTENDED RELEASE 60 mg ORAL NDA 34 sections
Kadian HUMAN PRESCRIPTION DRUG LABEL 1 0023-6017 CAPSULE, EXTENDED RELEASE 80 mg ORAL NDA 34 sections
Kadian HUMAN PRESCRIPTION DRUG LABEL 1 0023-6018 CAPSULE, EXTENDED RELEASE 100 mg ORAL NDA 34 sections
Kadian HUMAN PRESCRIPTION DRUG LABEL 1 0023-6019 CAPSULE, EXTENDED RELEASE 200 mg ORAL NDA 34 sections
Morphine Sulfate HUMAN PRESCRIPTION DRUG LABEL 1 0054-0235 TABLET 15 mg ORAL NDA 32 sections
Morphine Sulfate HUMAN PRESCRIPTION DRUG LABEL 1 0054-0236 TABLET 30 mg ORAL NDA 32 sections
Morphine Sulfate HUMAN PRESCRIPTION DRUG LABEL 1 0054-0237 SOLUTION 10 mg ORAL NDA 33 sections
Morphine Sulfate HUMAN PRESCRIPTION DRUG LABEL 1 0054-0237 SOLUTION 10 mg ORAL NDA 33 sections
Morphine Sulfate HUMAN PRESCRIPTION DRUG LABEL 1 0054-0238 SOLUTION 20 mg ORAL NDA 33 sections
Morphine Sulfate HUMAN PRESCRIPTION DRUG LABEL 1 0054-0238 SOLUTION 20 mg ORAL NDA 33 sections
Morphine Sulfate HUMAN PRESCRIPTION DRUG LABEL 1 0054-0404 SOLUTION 100 mg ORAL NDA 33 sections
Morphine Sulfate HUMAN PRESCRIPTION DRUG LABEL 1 0054-0404 SOLUTION 100 mg ORAL NDA 33 sections
Morphine Sulfate HUMAN PRESCRIPTION DRUG LABEL 1 0054-0517 SOLUTION 100 mg ORAL NDA 33 sections
Morphine Sulfate HUMAN PRESCRIPTION DRUG LABEL 1 0054-0517 SOLUTION 100 mg ORAL NDA 33 sections
Morphine Sulfate HUMAN PRESCRIPTION DRUG LABEL 1 0115-1277 CAPSULE, EXTENDED RELEASE 20 mg ORAL ANDA 33 sections
Morphine Sulfate HUMAN PRESCRIPTION DRUG LABEL 1 0115-1278 CAPSULE, EXTENDED RELEASE 30 mg ORAL ANDA 33 sections
Morphine Sulfate HUMAN PRESCRIPTION DRUG LABEL 1 0115-1279 CAPSULE, EXTENDED RELEASE 50 mg ORAL ANDA 33 sections
Morphine Sulfate HUMAN PRESCRIPTION DRUG LABEL 1 0115-1280 CAPSULE, EXTENDED RELEASE 60 mg ORAL ANDA 33 sections
Morphine Sulfate HUMAN PRESCRIPTION DRUG LABEL 1 0115-1281 CAPSULE, EXTENDED RELEASE 80 mg ORAL ANDA 33 sections
Morphine Sulfate HUMAN PRESCRIPTION DRUG LABEL 1 0115-1282 CAPSULE, EXTENDED RELEASE 100 mg ORAL ANDA 33 sections
Morphine Sulfate HUMAN PRESCRIPTION DRUG LABEL 1 0115-1479 CAPSULE, EXTENDED RELEASE 40 mg ORAL ANDA 33 sections
Morphine Sulfate HUMAN PRESCRIPTION DRUG LABEL 1 0121-0825 SOLUTION 100 mg ORAL ANDA 34 sections
Morphine Sulfate HUMAN PRESCRIPTION DRUG LABEL 1 0121-0904 SOLUTION 10 mg ORAL NDA 32 sections
Morphine Sulfate HUMAN PRESCRIPTION DRUG LABEL 1 0121-0904 SOLUTION 10 mg ORAL NDA 32 sections
Morphine sulfate HUMAN PRESCRIPTION DRUG LABEL 1 0228-3090 CAPSULE, EXTENDED RELEASE 30 mg ORAL ANDA 33 sections