morphine 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 ┬ÁM/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 6928.12 9.44 6036 150766 237789 46291471
Drug abuse 1000.05 9.44 1147 155655 62261 46466999
Toxicity to various agents 630.02 9.44 1846 154956 209920 46319340
Respiratory depression 353.59 9.44 301 156501 11299 46517961
Overdose 336.58 9.44 924 155878 101055 46428205
Accidental overdose 327.77 9.44 370 156432 19696 46509564
Respiratory arrest 324.39 9.44 479 156323 33337 46495923
Death 306.83 9.44 2051 154751 333497 46195763
Miosis 245.46 9.44 193 156609 6464 46522796
Drug dependence 238.82 9.44 314 156488 19587 46509673
Somnolence 198.83 9.44 1044 155758 155477 46373783
Sedation 189.41 9.44 303 156499 22607 46506653
Depressed level of consciousness 178.10 9.44 452 156350 47117 46482143
Cardiac arrest 161.98 9.44 667 156135 89732 46439528
Completed suicide 157.75 9.44 932 155870 144988 46384272
Contrast media allergy 153.78 9.44 88 156714 1711 46527549
Alopecia 152.36 9.44 193 156609 162221 46367039
Coma 150.73 9.44 485 156317 57864 46471396
Drug withdrawal syndrome 150.36 9.44 303 156499 27081 46502179
Cardio-respiratory arrest 146.90 9.44 489 156313 59380 46469880
Bradypnoea 145.34 9.44 103 156699 2936 46526324
Unresponsive to stimuli 142.18 9.44 326 156476 31848 46497412
Constipation 139.65 9.44 1032 155770 173065 46356195
Vomiting 138.34 9.44 2210 154592 450584 46078676
Pemphigus 126.73 9.44 6 156796 45268 46483992
Substance abuse 124.67 9.44 107 156695 4060 46525200
Inadequate analgesia 119.77 9.44 89 156713 2735 46526525
Respiratory rate decreased 116.45 9.44 91 156711 3019 46526241
Sedation complication 116.04 9.44 97 156705 3548 46525712
Hyperaesthesia 111.81 9.44 135 156667 7721 46521539
Product dose omission issue 111.22 9.44 251 156551 168269 46360991
Systemic lupus erythematosus 111.03 9.44 40 156762 65140 46464120
Myoclonus 106.74 9.44 181 156621 14171 46515089
Malignant neoplasm progression 105.38 9.44 465 156337 64461 46464799
Delirium 103.99 9.44 318 156484 36910 46492350
Intestinal pseudo-obstruction 98.30 9.44 47 156755 620 46528640
Confusional state 95.01 9.44 886 155916 159006 46370254
Hypotension 91.74 9.44 1188 155614 231401 46297859
Glossodynia 90.95 9.44 19 156783 44354 46484906
Acute chest syndrome 89.63 9.44 42 156760 528 46528732
Mental status changes 88.90 9.44 306 156496 37782 46491478
Exposure via ingestion 87.77 9.44 81 156721 3386 46525874
Headache 86.22 9.44 1112 155690 477240 46052020
Drug abuser 84.70 9.44 77 156725 3156 46526104
Creatinine renal clearance decreased 82.71 9.44 109 156693 6811 46522449
Fatigue 79.96 9.44 1503 155299 607194 45922066
Drug screen positive 79.85 9.44 81 156721 3810 46525450
Injection site pain 79.63 9.44 149 156653 107003 46422257
Poisoning 79.39 9.44 157 156645 13837 46515423
Device expulsion 79.24 9.44 3 156799 27539 46501721
Soft tissue disorder 78.45 9.44 83 156719 4103 46525157
Drug diversion 75.97 9.44 43 156759 818 46528442
Maternal exposure during delivery 75.38 9.44 42 156760 774 46528486
Abdominal discomfort 74.58 9.44 259 156543 150906 46378354
Hallucination 73.78 9.44 348 156454 49603 46479657
Off label use 73.63 9.44 869 155933 378972 46150288
Injection site erythema 73.37 9.44 85 156717 74342 46454918
Arthropathy 68.17 9.44 112 156690 84588 46444672
Drug ineffective 65.28 9.44 1757 155045 676081 45853179
Dizziness 64.71 9.44 782 156020 339632 46189628
White blood cell count abnormal 64.71 9.44 83 156719 5049 46524211
Arthralgia 63.95 9.44 852 155950 363751 46165509
Apnoea 63.31 9.44 99 156703 7240 46522020
Abortion spontaneous 62.95 9.44 34 156768 43612 46485648
Rheumatoid arthritis 61.79 9.44 513 156289 239702 46289558
Drug tolerance 57.12 9.44 62 156740 3156 46526104
Intentional product misuse 56.73 9.44 310 156492 46818 46482442
Rheumatoid factor positive 56.34 9.44 3 156799 20458 46508802
Nasopharyngitis 56.18 9.44 296 156506 153702 46375558
Respiratory failure 56.05 9.44 525 156277 94291 46434969
Injection site reaction 54.75 9.44 48 156754 47801 46481459
Dilatation intrahepatic duct acquired 54.18 9.44 33 156769 723 46528537
Diarrhoea 52.86 9.44 1454 155348 558148 45971112
Hypercapnia 50.92 9.44 70 156732 4556 46524704
Withdrawal syndrome 50.72 9.44 155 156647 17979 46511281
Asphyxia 50.40 9.44 75 156727 5251 46524009
Blood calcium decreased 48.63 9.44 139 156663 15534 46513726
Cough 48.36 9.44 517 156285 229732 46299528
Sinusitis 48.12 9.44 248 156554 129520 46399740
Obliterative bronchiolitis 47.93 9.44 43 156759 1732 46527528
Injection site pruritus 47.77 9.44 38 156764 39705 46489555
Poisoning deliberate 47.49 9.44 91 156711 7835 46521425
Pain 46.10 9.44 1999 154803 474949 46054311
Cardiac failure congestive 46.03 9.44 156 156646 91594 46437666
Anterior spinal artery syndrome 44.69 9.44 14 156788 50 46529210
Hypoxia 44.17 9.44 312 156490 51526 46477734
Injection site swelling 43.14 9.44 43 156759 40284 46488976
Respiratory acidosis 42.40 9.44 75 156727 6073 46523187
Hand deformity 41.63 9.44 33 156769 34541 46494719
Weight increased 40.12 9.44 356 156446 164117 46365143
Drug withdrawal syndrome neonatal 39.31 9.44 40 156762 1888 46527372
Pulseless electrical activity 38.97 9.44 79 156723 7088 46522172
Asthma 38.59 9.44 167 156635 91375 46437885
Acidosis 38.53 9.44 103 156699 11071 46518189
Urinary retention 38.06 9.44 181 156621 25880 46503380
Cancer pain 38.00 9.44 44 156758 2406 46526854
Lethargy 37.93 9.44 298 156504 50873 46478387
Accidental death 37.29 9.44 38 156764 1797 46527463
Maternal exposure during pregnancy 36.88 9.44 198 156604 102351 46426909
Accidental exposure to product by child 35.98 9.44 30 156772 1093 46528167
Systemic mastocytosis 35.21 9.44 15 156787 148 46529112
Visceral congestion 34.96 9.44 18 156784 281 46528979
Agitation 34.84 9.44 311 156491 55104 46474156
Narcotic bowel syndrome 34.78 9.44 14 156788 118 46529142
Nasal congestion 34.76 9.44 68 156734 48045 46481215
Sphincter of Oddi dysfunction 34.55 9.44 19 156783 341 46528919
Myalgia 34.32 9.44 257 156545 122831 46406429
Foetal megacystis 34.27 9.44 10 156792 26 46529234
Iodine allergy 34.13 9.44 22 156780 534 46528726
Erythema 34.01 9.44 311 156491 142509 46386751
Anaphylactic reaction 32.84 9.44 297 156505 52815 46476445
Pneumonia viral 32.49 9.44 70 156732 6554 46522706
Pain in extremity 32.14 9.44 644 156158 258036 46271224
Abdominal pain 32.07 9.44 1005 155797 229026 46300234
Oxygen saturation decreased 31.84 9.44 364 156438 68800 46460460
Allodynia 31.72 9.44 21 156781 534 46528726
Pancreatic fibrosis 31.48 9.44 12 156790 86 46529174
Pericarditis 31.19 9.44 21 156781 23906 46505354
Sopor 30.77 9.44 14 156788 19814 46509446
Gangrene 30.74 9.44 56 156746 4639 46524621
Pulmonary oedema 30.69 9.44 284 156518 50821 46478439
Coronary artery disease 30.68 9.44 41 156761 33711 46495549
Wrong technique in product usage process 30.49 9.44 88 156714 54334 46474926
Pregnancy 30.11 9.44 28 156774 27109 46502151
Aspiration 30.03 9.44 85 156717 9446 46519814
No adverse event 29.70 9.44 43 156759 34188 46495072
Post procedural complication 29.67 9.44 118 156684 15611 46513649
Condition aggravated 28.40 9.44 617 156185 244435 46284825
Colitis microscopic 27.39 9.44 65 156737 6491 46522769
Cyanosis 26.35 9.44 115 156687 15856 46513404
Myocardial infarction 26.07 9.44 206 156596 97322 46431938
Infective pulmonary exacerbation of cystic fibrosis 25.82 9.44 3 156799 10804 46518456
Implant site extravasation 25.74 9.44 18 156784 502 46528758
Osteoarthritis 25.62 9.44 114 156688 61911 46467349
Nausea 25.55 9.44 2658 154144 684796 45844464
Transient ischaemic attack 25.50 9.44 49 156753 34854 46494406
Cerebrovascular accident 25.37 9.44 217 156585 100822 46428438
Cholestasis 25.37 9.44 166 156636 26727 46502533
Ear infection 25.23 9.44 24 156778 22989 46506271
Hepatic enzyme increased 25.12 9.44 166 156636 81621 46447639
Injection site rash 24.80 9.44 11 156791 15802 46513458
Disease progression 24.50 9.44 437 156365 90863 46438397
Dyspnoea exertional 24.21 9.44 87 156715 50202 46479058
Helicobacter infection 24.10 9.44 5 156797 11731 46517529
Breakthrough pain 23.67 9.44 24 156778 1128 46528132
Pruritus allergic 23.64 9.44 23 156779 1028 46528232
Pupil fixed 23.57 9.44 29 156773 1691 46527569
Tonsillar disorder 23.55 9.44 22 156780 934 46528326
Hypoxic-ischaemic encephalopathy 23.47 9.44 46 156756 4027 46525233
Spinal epidural haemorrhage 23.35 9.44 10 156792 100 46529160
Vascular resistance systemic decreased 23.09 9.44 10 156792 103 46529157
Drug resistance 22.97 9.44 15 156787 17353 46511907
Syncope 22.50 9.44 234 156568 104569 46424691
Toxic leukoencephalopathy 22.50 9.44 17 156785 536 46528724
Metastases to bone 22.41 9.44 117 156685 17359 46511901
Complex regional pain syndrome 22.34 9.44 31 156771 2035 46527225
Mucosal inflammation 22.11 9.44 214 156588 38762 46490498
Femur fracture 22.08 9.44 58 156744 36939 46492321
Breast cancer 21.74 9.44 79 156723 45439 46483821
Basal cell carcinoma 21.73 9.44 22 156780 20465 46508795
Spinal cord compression 21.71 9.44 42 156760 3642 46525618
Implant site discharge 21.68 9.44 10 156792 121 46529139
Sepsis 21.30 9.44 603 156199 135411 46393849
Medication error 21.27 9.44 177 156625 30734 46498526
Gallbladder cholesterolosis 21.25 9.44 19 156783 762 46528498
Antinuclear antibody negative 21.21 9.44 12 156790 228 46529032
Catheter site granuloma 21.16 9.44 5 156797 3 46529257
Progressive multifocal leukoencephalopathy 21.02 9.44 6 156796 11340 46517920
Peripheral nerve injury 20.91 9.44 14 156788 363 46528897
Urinary bladder rupture 20.84 9.44 10 156792 133 46529127
Hypoventilation 20.81 9.44 44 156758 4066 46525194
Anaesthetic complication 20.76 9.44 28 156774 1789 46527471
Cardiac output decreased 20.59 9.44 20 156782 892 46528368
Product quality issue 20.44 9.44 57 156745 35591 46493669
Injection site bruising 20.42 9.44 57 156745 35579 46493681
Incoherent 20.23 9.44 46 156756 4466 46524794
Influenza like illness 20.22 9.44 112 156690 57458 46471802
Cognitive disorder 20.18 9.44 201 156601 36682 46492578
Musculoskeletal stiffness 20.14 9.44 221 156581 97772 46431488
Patient uncooperative 19.95 9.44 10 156792 147 46529113
Contusion 19.75 9.44 193 156609 87294 46441966
Red blood cell sedimentation rate increased 19.61 9.44 29 156773 22860 46506400
Serotonin syndrome 19.60 9.44 144 156658 24076 46505184
Small intestinal obstruction 19.20 9.44 106 156696 16066 46513194
Palpitations 19.12 9.44 216 156586 95043 46434217
Orthostatic hypotension 19.04 9.44 145 156657 24513 46504747
White blood cell count decreased 18.96 9.44 264 156538 111967 46417293
Pulmonary congestion 18.93 9.44 99 156703 14700 46514560
Interstitial lung disease 18.92 9.44 105 156697 53844 46475416
Suicide attempt 18.83 9.44 108 156694 54928 46474332
Hospitalisation 18.79 9.44 130 156672 63255 46466005
Contraindicated product administered 18.62 9.44 175 156627 79772 46449488
Respiratory rate increased 18.62 9.44 82 156720 11351 46517909
Metastases to eye 18.54 9.44 9 156793 123 46529137
Treatment failure 18.32 9.44 212 156590 92875 46436385
Sickle cell anaemia with crisis 18.24 9.44 41 156761 3951 46525309
Infusion related reaction 18.21 9.44 235 156567 100973 46428287
Foetal heart rate abnormal 18.19 9.44 15 156787 538 46528722
Loss of personal independence in daily activities 18.10 9.44 115 156687 57068 46472192
Therapy cessation 18.08 9.44 39 156763 26590 46502670
Gastrooesophageal reflux disease 18.07 9.44 161 156641 74183 46455077
Injection site warmth 18.07 9.44 12 156790 13760 46515500
Bronchitis 18.01 9.44 249 156553 105730 46423530
Tendonitis 17.99 9.44 13 156789 14264 46514996
Seronegative arthritis 17.90 9.44 17 156785 737 46528523
Hepatic function abnormal 17.61 9.44 58 156744 34363 46494897
Intentional self-injury 17.59 9.44 34 156768 24132 46505128
Respiratory distress 17.50 9.44 174 156628 31742 46497518
Atrial fibrillation 17.38 9.44 244 156558 103346 46425914
Retrograde amnesia 17.27 9.44 12 156790 331 46528929
Increased bronchial secretion 17.13 9.44 24 156778 1590 46527670
Brain oedema 17.02 9.44 85 156717 12393 46516867
Central nervous system injury 17.01 9.44 9 156793 149 46529111
Chronic kidney disease 16.95 9.44 75 156727 40796 46488464
Substance use 16.88 9.44 13 156789 422 46528838
Administration site abscess 16.87 9.44 5 156797 14 46529246
Disorientation 16.85 9.44 194 156608 36724 46492536
Blood pH decreased 16.78 9.44 31 156771 2596 46526664
Herpes simplex reactivation 16.75 9.44 12 156790 348 46528912
Throat irritation 16.73 9.44 46 156756 28855 46500405
Neuroendocrine tumour of the lung 16.62 9.44 5 156797 15 46529245
Fluid retention 16.49 9.44 102 156700 50944 46478316
Rash 16.48 9.44 1005 155797 355507 46173753
Multiple sclerosis relapse 16.46 9.44 79 156723 42046 46487214
Peptic ulcer perforation 16.39 9.44 9 156793 161 46529099
Hallucination, tactile 16.34 9.44 10 156792 221 46529039
Abortion induced 16.31 9.44 7 156795 10253 46519007
Arterial occlusive disease 16.28 9.44 44 156758 4760 46524500
Influenza 16.16 9.44 207 156595 89063 46440197
Administration site induration 16.15 9.44 5 156797 17 46529243
Faecaloma 16.13 9.44 60 156742 7692 46521568
Flushing 16.11 9.44 139 156663 64475 46464785
Congenital pulmonary hypertension 16.09 9.44 7 156795 73 46529187
Coombs positive haemolytic anaemia 15.89 9.44 12 156790 378 46528882
Gastrointestinal disorder 15.84 9.44 126 156676 59450 46469810
Abnormal behaviour 15.80 9.44 123 156679 20935 46508325
Cardiac failure 15.76 9.44 182 156620 79766 46449494
Wound 15.73 9.44 82 156720 42720 46486540
Blood pressure diastolic increased 15.72 9.44 50 156752 5924 46523336
Administration site discharge 15.72 9.44 5 156797 19 46529241
Tumour pain 15.69 9.44 20 156782 1209 46528051
Bradycardia 15.60 9.44 311 156491 65987 46463273
Weaning failure 15.51 9.44 11 156791 314 46528946
Myocardial fibrosis 15.48 9.44 14 156788 570 46528690
Withdrawal catatonia 15.40 9.44 6 156796 46 46529214
Vertigo 15.30 9.44 107 156695 51941 46477319
Ill-defined disorder 15.30 9.44 43 156759 26784 46502476
Pupillary reflex impaired 15.27 9.44 26 156776 2042 46527218
Excessive eye blinking 15.25 9.44 14 156788 581 46528679
Asthenia 15.24 9.44 872 155930 310203 46219057
Alveolitis 15.24 9.44 29 156773 2484 46526776
Posterior reversible encephalopathy syndrome 15.23 9.44 95 156707 15046 46514214
Toxicologic test abnormal 15.17 9.44 15 156787 684 46528576
Breast cancer metastatic 15.15 9.44 88 156714 13590 46515670
Infusion 15.09 9.44 8 156794 133 46529127
Liver disorder 15.05 9.44 69 156733 37177 46492083
Sternal fracture 14.96 9.44 22 156780 1524 46527736
Injection site urticaria 14.94 9.44 11 156791 11956 46517304
Epidural analgesia 14.86 9.44 6 156796 51 46529209
Duodenal ulcer perforation 14.85 9.44 5 156797 8497 46520763
Product use issue 14.81 9.44 226 156576 94418 46434842
Thymus disorder 14.78 9.44 9 156793 197 46529063
Neutropenic sepsis 14.78 9.44 81 156721 12243 46517017
Visual impairment 14.68 9.44 148 156654 66541 46462719
Cytomegalovirus infection 14.58 9.44 24 156778 18120 46511140
Therapeutic response decreased 14.58 9.44 85 156717 43060 46486200
Eye disorder 14.57 9.44 24 156778 18117 46511143
Anaesthesia 14.47 9.44 6 156796 55 46529205
Clonus 14.46 9.44 38 156764 4042 46525218
Myelodysplastic syndrome 14.36 9.44 19 156783 15692 46513568
Hallucination, visual 14.31 9.44 106 156696 17767 46511493
Neuromuscular block prolonged 14.30 9.44 13 156789 533 46528727
Intraventricular haemorrhage neonatal 14.28 9.44 8 156794 149 46529111
Swelling 14.25 9.44 314 156488 124197 46405063
Gastrointestinal haemorrhage 14.16 9.44 179 156623 77194 46452066
Agonal death struggle 14.10 9.44 3 156799 0 46529260
Infusion site granuloma 14.10 9.44 3 156799 0 46529260
Injection site discolouration 14.07 9.44 3 156799 6907 46522353
Sinus congestion 13.99 9.44 14 156788 13095 46516165
Product name confusion 13.84 9.44 6 156796 62 46529198
Encephalopathy 13.79 9.44 173 156629 33416 46495844
PO2 decreased 13.79 9.44 21 156781 1501 46527759
Psoriatic arthropathy 13.77 9.44 69 156733 36310 46492950
Joint effusion 13.76 9.44 12 156790 11983 46517277
Joint swelling 13.70 9.44 439 156363 165634 46363626
Product use in unapproved indication 13.64 9.44 217 156585 90056 46439204
Hip arthroplasty 13.61 9.44 25 156777 18087 46511173
Administration site odour 13.60 9.44 5 156797 32 46529228
Neonatal tachypnoea 13.59 9.44 6 156796 65 46529195
Stroke volume increased 13.55 9.44 4 156798 11 46529249
Haematoma 13.51 9.44 58 156744 31814 46497446
Blood glucose increased 13.40 9.44 166 156636 71847 46457413
Tubulointerstitial nephritis 13.40 9.44 18 156784 14770 46514490
Hypercreatininaemia 13.38 9.44 11 156791 393 46528867
Haemangioma of skin 13.35 9.44 10 156792 311 46528949
Implant site infection 13.25 9.44 16 156786 915 46528345
Metastasis 13.14 9.44 38 156764 4274 46524986
Granuloma 13.08 9.44 35 156767 3763 46525497
Transplant rejection 13.08 9.44 8 156794 9588 46519672
Genital haemorrhage 13.07 9.44 3 156799 6563 46522697
Pulmonary arterial hypertension 13.05 9.44 44 156758 25884 46503376
Epidural haemorrhage 13.01 9.44 7 156795 120 46529140
Menstruation irregular 12.99 9.44 3 156799 6536 46522724
Neoplasm progression 12.99 9.44 142 156660 26541 46502719
Dry eye 12.96 9.44 55 156747 30267 46498993
C-reactive protein abnormal 12.96 9.44 33 156769 21237 46508023
Stridor 12.93 9.44 31 156771 3116 46526144
Muscle twitching 12.90 9.44 89 156713 14583 46514677
Injection site cyst 12.76 9.44 5 156797 39 46529221
Nasal disorder 12.75 9.44 25 156777 2189 46527071
Metastases to spine 12.68 9.44 28 156774 2666 46526594
Dose calculation error 12.65 9.44 5 156797 40 46529220
Thirst decreased 12.64 9.44 8 156794 188 46529072
Feeling jittery 12.64 9.44 11 156791 10997 46518263
Ischaemic stroke 12.63 9.44 23 156779 16699 46512561
Hepatocellular injury 12.53 9.44 153 156649 29369 46499891
Livedo reticularis 12.52 9.44 25 156777 2219 46527041
Spinal cord paralysis 12.44 9.44 5 156797 42 46529218
Occupational dermatitis 12.44 9.44 5 156797 42 46529218
Myoglobin urine 12.41 9.44 4 156798 16 46529244
Cardiac output increased 12.24 9.44 7 156795 136 46529124
Therapy interrupted 12.13 9.44 11 156791 10780 46518480
Inappropriate schedule of product administration 12.05 9.44 150 156652 64863 46464397
Self-medication 12.03 9.44 24 156778 2128 46527132
Analgesic therapy 12.03 9.44 3 156799 3 46529257
Back pain 11.97 9.44 839 155963 209200 46320060
Splenic injury 11.96 9.44 8 156794 207 46529053
Schizophrenia 11.88 9.44 7 156795 8561 46520699
Intestinal strangulation 11.86 9.44 6 156796 90 46529170
Sinus tachycardia 11.85 9.44 118 156684 21531 46507729
Dyspnoea 11.85 9.44 1534 155268 514014 46015246
Blood pressure systolic decreased 11.78 9.44 42 156760 5276 46523984
Intentional product use issue 11.67 9.44 117 156685 52663 46476597
Blood phosphorus decreased 11.64 9.44 34 156768 3846 46525414
Learning disability 11.58 9.44 6 156796 95 46529165
Brain injury 11.49 9.44 46 156756 6104 46523156
Lupus-like syndrome 11.47 9.44 6 156796 7838 46521422
Autoimmune hepatitis 11.39 9.44 6 156796 7808 46521452
Myopathy 11.30 9.44 8 156794 8873 46520387
Drug use disorder 11.30 9.44 27 156775 2708 46526552
Dysphonia 11.28 9.44 79 156723 38335 46490925
Rhythm idioventricular 11.23 9.44 7 156795 160 46529100
Postoperative ileus 11.23 9.44 11 156791 496 46528764
Sepsis neonatal 11.23 9.44 10 156792 399 46528861
Hyponatraemia 11.18 9.44 257 156545 101075 46428185
Skin cancer 11.16 9.44 8 156794 8815 46520445
Fear-related avoidance of activities 11.15 9.44 6 156796 103 46529157
Myelosuppression 11.11 9.44 6 156796 7697 46521563
Bone marrow eosinophilic leukocyte count increased 11.10 9.44 4 156798 24 46529236
Buttock injury 11.10 9.44 6 156796 104 46529156
Skin lesion 11.09 9.44 49 156753 26664 46502596
Rash pruritic 11.07 9.44 95 156707 44120 46485140
Heat stroke 11.07 9.44 12 156790 610 46528650
Neuropathy peripheral 11.04 9.44 227 156575 90666 46438594
Fibromyalgia 11.04 9.44 178 156624 36285 46492975
Paraesthesia oral 11.01 9.44 14 156788 11759 46517501
Laryngectomy 10.96 9.44 4 156798 25 46529235
Anaesthetic complication pulmonary 10.95 9.44 5 156797 59 46529201
Cystitis 10.92 9.44 90 156712 42151 46487109
Dyspepsia 10.88 9.44 163 156639 68309 46460951
Blood pressure systolic increased 10.87 9.44 146 156656 28641 46500619
Cardiopulmonary failure 10.86 9.44 32 156770 3637 46525623
Suicidal ideation 10.86 9.44 129 156673 56253 46473007
Sensory loss 10.86 9.44 49 156753 6853 46522407
Impaired work ability 10.83 9.44 16 156786 12620 46516640
Peritonitis bacterial 10.74 9.44 8 156794 8645 46520615
Eye irritation 10.73 9.44 25 156777 16589 46512671
Neurogenic shock 10.70 9.44 8 156794 248 46529012
Metastases to oesophagus 10.70 9.44 4 156798 27 46529233
Denture wearer 10.68 9.44 8 156794 249 46529011
Pituitary apoplexy 10.65 9.44 6 156796 113 46529147
Tenosynovitis 10.62 9.44 6 156796 7509 46521751
Acne 10.58 9.44 33 156769 19886 46509374
Pemphigoid 10.56 9.44 3 156799 5688 46523572
Administration site haemorrhage 10.52 9.44 5 156797 65 46529195
Phaeochromocytoma crisis 10.47 9.44 7 156795 181 46529079
Antinuclear antibody positive 10.44 9.44 4 156798 6276 46522984
Hyperreflexia 10.38 9.44 40 156762 5214 46524046
Spinal cord injury 10.34 9.44 11 156791 547 46528713
Allergic hepatitis 10.34 9.44 4 156798 30 46529230
Parkinsonism 10.33 9.44 7 156795 7941 46521319
Abdominal hernia 10.27 9.44 37 156765 4671 46524589
Bone marrow failure 10.26 9.44 58 156744 29611 46499649
Tooth hypoplasia 10.26 9.44 5 156797 69 46529191
Ocular hyperaemia 10.23 9.44 33 156769 19677 46509583
Incision site swelling 10.23 9.44 4 156798 31 46529229
Rhinitis 10.22 9.44 7 156795 7899 46521361
Nervousness 10.22 9.44 55 156747 28420 46500840
Adiposis dolorosa 10.20 9.44 8 156794 267 46528993
Dependence 10.16 9.44 21 156781 1910 46527350
Spinal cord oedema 10.16 9.44 6 156796 124 46529136
Terminal state 10.13 9.44 23 156779 2231 46527029
Ear pain 10.12 9.44 39 156763 22053 46507207
Foetal monitoring abnormal 10.12 9.44 6 156796 125 46529135
Peripheral swelling 10.08 9.44 431 156371 157640 46371620
Meningitis chemical 10.07 9.44 6 156796 126 46529134
Cor pulmonale 10.07 9.44 21 156781 1922 46527338
Lumbosacral plexopathy 9.97 9.44 3 156799 9 46529251
Documented hypersensitivity to administered product 9.91 9.44 11 156791 574 46528686
Toothache 9.91 9.44 26 156776 16566 46512694
Hip surgery 9.86 9.44 24 156778 2436 46526824
Bone cancer 9.85 9.44 15 156787 1072 46528188
Lung cancer metastatic 9.81 9.44 24 156778 2444 46526816
Troponin increased 9.80 9.44 52 156750 7764 46521496
Hypochromasia 9.77 9.44 8 156794 284 46528976
Body temperature increased 9.76 9.44 127 156675 24734 46504526
Respiratory paralysis 9.73 9.44 3 156799 10 46529250
COVID-19 9.71 9.44 31 156771 18544 46510716
Incorrect drug administration rate 9.71 9.44 21 156781 1972 46527288
Vision blurred 9.70 9.44 199 156603 79509 46449751
Haemorrhage 9.65 9.44 128 156674 54741 46474519
Haematochezia 9.64 9.44 80 156722 37413 46491847
Suspected suicide 9.64 9.44 36 156766 4625 46524635
Infrequent bowel movements 9.63 9.44 15 156787 1093 46528167
Hypoacusis 9.62 9.44 37 156765 20932 46508328
Swelling face 9.61 9.44 123 156679 52936 46476324
Neuralgia 9.59 9.44 112 156690 21271 46507989
Acute kidney injury 9.56 9.44 918 155884 234937 46294323
Prescription drug used without a prescription 9.53 9.44 17 156785 1385 46527875
Eye swelling 9.53 9.44 35 156767 20068 46509192
Pocket erosion 9.51 9.44 3 156799 11 46529249
Blood creatine phosphokinase MB increased 9.50 9.44 16 156786 1245 46528015
Hypercholesterolaemia 9.50 9.44 15 156787 11515 46517745
Cataract 9.50 9.44 102 156700 45313 46483947
Factitious disorder 9.49 9.44 5 156797 82 46529178
Uveitis 9.49 9.44 9 156793 8632 46520628
Eye pain 9.46 9.44 55 156747 27885 46501375
Antisocial behaviour 9.45 9.44 7 156795 214 46529046

FDA Adverse Event Reporting System (Male)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Drug hypersensitivity 1340.07 10.20 1504 118005 67015 29765954
Toxicity to various agents 1215.59 10.20 2370 117139 174813 29658156
Drug abuse 1062.82 10.20 1465 118044 80607 29752362
Respiratory depression 571.88 10.20 427 119082 11076 29821893
Overdose 534.74 10.20 1094 118415 83243 29749726
Drug dependence 384.00 10.20 449 119060 20846 29812123
Accidental overdose 378.34 10.20 414 119095 17861 29815108
Substance abuse 250.81 10.20 215 119294 6825 29826144
Miosis 246.04 10.20 222 119287 7554 29825415
Somnolence 227.17 10.20 874 118635 95889 29737080
Respiratory arrest 222.15 10.20 410 119099 28848 29804121
Death 205.28 10.20 2250 117259 355033 29477936
Unresponsive to stimuli 175.69 10.20 350 119159 26069 29806900
Drug withdrawal syndrome 168.82 10.20 292 119217 19517 29813452
Delirium 166.80 10.20 445 119064 40186 29792783
Hyperaesthesia 154.22 10.20 122 119387 3451 29829518
Pain 149.93 10.20 1189 118320 171452 29661517
Malignant neoplasm progression 144.14 10.20 621 118888 71666 29761303
Mental status changes 137.20 10.20 391 119118 36688 29796281
Sedation 136.45 10.20 239 119270 16134 29816835
Bradypnoea 134.47 10.20 88 119421 1833 29831136
Poisoning 130.31 10.20 192 119317 11190 29821779
Coma 128.34 10.20 404 119105 40045 29792924
Constipation 122.82 10.20 821 118688 112085 29720884
Confusional state 121.00 10.20 936 118573 133898 29699071
Intentional product misuse 119.07 10.20 356 119153 34311 29798658
Inadequate analgesia 118.03 10.20 93 119416 2615 29830354
Acute chest syndrome 113.34 10.20 43 119466 249 29832720
Drug screen positive 112.99 10.20 112 119397 4295 29828674
Respiratory rate decreased 112.29 10.20 77 119432 1738 29831231
Off label use 112.03 10.20 563 118946 248727 29584242
Depressed level of consciousness 109.75 10.20 369 119140 37853 29795116
Cardio-respiratory arrest 103.40 10.20 478 119031 56828 29776141
Lethargy 99.22 10.20 365 119144 39154 29793815
Pulmonary oedema 97.16 10.20 390 119119 43585 29789384
Accidental death 94.07 10.20 73 119436 2006 29830963
Cardiac arrest 87.36 10.20 652 118857 92198 29740771
Drug abuser 86.37 10.20 97 119412 4304 29828665
Myocardial infarction 84.04 10.20 241 119268 125384 29707585
Completed suicide 81.16 10.20 676 118833 98816 29734153
Withdrawal syndrome 80.79 10.20 154 119355 11096 29821873
Apnoea 75.16 10.20 108 119401 6150 29826819
Vomiting 72.35 10.20 1255 118254 218563 29614406
Agitation 70.44 10.20 412 119097 53661 29779308
Asphyxia 68.67 10.20 96 119413 5329 29827640
Cardiac failure congestive 68.07 10.20 147 119362 84260 29748709
Myalgia 63.09 10.20 132 119377 76535 29756434
Product dose omission issue 62.56 10.20 174 119335 91457 29741512
Drug ineffective 59.28 10.20 979 118530 339408 29493561
Product use in unapproved indication 57.23 10.20 131 119378 73562 29759407
Cytomegalovirus infection 55.70 10.20 13 119496 23661 29809308
Brain oedema 54.11 10.20 139 119370 12259 29820710
Nausea 53.17 10.20 1555 117954 295402 29537567
Sedation complication 50.69 10.20 35 119474 799 29832170
Coronary artery disease 46.68 10.20 79 119430 49633 29783336
Hypogonadism male 45.60 10.20 22 119487 246 29832723
Hypoxia 44.92 10.20 336 119173 47518 29785451
Cerebrovascular accident 44.27 10.20 177 119332 83300 29749669
Myoclonus 44.07 10.20 135 119374 13177 29819792
Renal impairment 43.70 10.20 180 119329 84004 29748965
Oxygen saturation decreased 43.64 10.20 310 119199 43130 29789839
Pulmonary congestion 42.94 10.20 127 119382 12160 29820809
Cancer pain 42.17 10.20 51 119458 2451 29830518
Cough 41.98 10.20 311 119198 125331 29707638
Dizziness 40.22 10.20 542 118967 194367 29638602
Psoriasis 39.49 10.20 68 119441 42438 29790531
Hypoventilation 39.01 10.20 54 119455 2969 29830000
Drug resistance 38.53 10.20 16 119493 20117 29812852
Syncope 38.41 10.20 191 119318 84712 29748257
Exposure via ingestion 37.29 10.20 49 119460 2562 29830407
Pneumonia aspiration 37.01 10.20 268 119241 37512 29795457
Treatment failure 36.50 10.20 51 119458 34628 29798341
Hypoxic-ischaemic encephalopathy 35.94 10.20 66 119443 4621 29828348
Diarrhoea 34.99 10.20 1041 118468 333062 29499907
Foetal exposure during pregnancy 34.24 10.20 59 119450 36812 29796157
Breakthrough pain 33.97 10.20 24 119485 569 29832400
Melaena 33.84 10.20 48 119461 32389 29800580
Headache 33.38 10.20 519 118990 181787 29651182
Drug use disorder 33.22 10.20 52 119457 3196 29829773
Metastases to bone 32.96 10.20 99 119410 9559 29823410
Sphincter of Oddi dysfunction 32.35 10.20 14 119495 119 29832850
Serotonin syndrome 32.05 10.20 149 119360 17742 29815227
Hospitalisation 31.85 10.20 82 119427 44237 29788732
Urinary retention 31.38 10.20 232 119277 32685 29800284
Blood pH decreased 31.13 10.20 42 119467 2253 29830716
Diaphragmatic spasm 30.21 10.20 12 119497 80 29832889
Leukopenia 29.81 10.20 119 119390 56040 29776929
Faecal volume decreased 29.72 10.20 12 119497 84 29832885
Visual acuity reduced 29.67 10.20 13 119496 15833 29817136
Respiratory acidosis 29.52 10.20 57 119452 4145 29828824
Dyspnoea 29.29 10.20 1062 118447 332233 29500736
Drug eruption 28.90 10.20 17 119492 17509 29815460
Drug tolerance 28.47 10.20 39 119470 2123 29830846
Respiratory distress 28.43 10.20 227 119282 32745 29800224
Diabetes mellitus inadequate control 28.12 10.20 8 119501 12754 29820215
Hallucination 27.87 10.20 309 119200 48750 29784219
Haematuria 27.79 10.20 89 119420 44745 29788224
Sinus tachycardia 27.69 10.20 129 119380 15375 29817594
Disease progression 27.23 10.20 459 119050 79415 29753554
Hyperhidrosis 27.22 10.20 397 119112 66693 29766276
Fatigue 27.00 10.20 1027 118482 319646 29513323
Drug diversion 26.73 10.20 25 119484 891 29832078
PCO2 increased 26.09 10.20 21 119488 609 29832360
Tubulointerstitial nephritis 25.95 10.20 20 119489 17871 29815098
Hypertension 25.89 10.20 335 119174 121019 29711950
Glycosylated haemoglobin increased 24.88 10.20 4 119505 9487 29823482
Atrial fibrillation 24.75 10.20 294 119215 107830 29725139
Blood glucose increased 24.72 10.20 144 119365 61386 29771583
Basal cell carcinoma 24.55 10.20 17 119492 16051 29816918
Toxicologic test abnormal 24.47 10.20 20 119489 593 29832376
Hepatic function abnormal 24.13 10.20 86 119423 41859 29791110
Self-medication 23.84 10.20 37 119472 2257 29830712
Opiates positive 23.18 10.20 14 119495 252 29832717
Cardiac failure 23.07 10.20 217 119292 83201 29749768
Weight increased 22.86 10.20 190 119319 74723 29758246
Drug level 22.64 10.20 5 119504 0 29832969
Lung cancer metastatic 22.49 10.20 38 119471 2490 29830479
Postoperative ileus 22.49 10.20 20 119489 667 29832302
Chronic kidney disease 22.15 10.20 77 119432 37761 29795208
Arthralgia 22.07 10.20 395 119114 135396 29697573
Peritonitis bacterial 21.84 10.20 9 119500 11369 29821600
Angina unstable 21.66 10.20 11 119498 12299 29820670
Intestinal obstruction 21.60 10.20 141 119368 19071 29813898
Secondary hypogonadism 21.42 10.20 14 119495 291 29832678
Neoplasm progression 21.33 10.20 134 119375 17889 29815080
Clumsiness 21.33 10.20 27 119482 1360 29831609
Tumour pain 21.28 10.20 23 119486 977 29831992
Muscle swelling 21.07 10.20 15 119494 360 29832609
Bladder dilatation 20.91 10.20 26 119483 1286 29831683
Orthostatic hypotension 20.81 10.20 40 119469 23939 29809030
Anaemia 20.73 10.20 652 118857 207340 29625629
Aspiration 20.49 10.20 90 119419 10461 29822508
Spinal cord compression 20.20 10.20 45 119464 3621 29829348
Medication error 20.09 10.20 148 119361 20824 29812145
Eosinophilia 20.08 10.20 36 119473 22124 29810845
Abdominal compartment syndrome 20.05 10.20 21 119488 860 29832109
Bone marrow failure 19.98 10.20 57 119452 29728 29803241
Drug-induced liver injury 19.79 10.20 34 119475 21240 29811729
Interstitial lung disease 19.13 10.20 151 119358 60046 29772923
Device failure 18.73 10.20 32 119477 2116 29830853
Back pain 18.72 10.20 539 118970 102057 29730912
Neutropenia 18.70 10.20 381 119128 128159 29704810
Weaning failure 18.33 10.20 12 119497 250 29832719
Hypopnoea 18.22 10.20 23 119486 1155 29831814
Fall 18.14 10.20 570 118939 181302 29651667
Neuroleptic malignant syndrome 18.12 10.20 23 119486 16272 29816697
Sinusitis 18.11 10.20 70 119439 33275 29799694
Angina pectoris 18.01 10.20 59 119450 29459 29803510
Poisoning deliberate 17.82 10.20 58 119451 5846 29827123
Hepatic enzyme increased 17.75 10.20 71 119438 33423 29799546
Hypoglycaemia 17.57 10.20 125 119384 50856 29782113
Progressive multifocal leukoencephalopathy 17.51 10.20 7 119502 9006 29823963
Neuropathy peripheral 17.14 10.20 189 119320 70286 29762683
Stupor 17.13 10.20 37 119472 2916 29830053
Plasma cell myeloma 17.05 10.20 304 119205 53158 29779811
Post procedural complication 17.01 10.20 92 119417 11634 29821335
Pupil fixed 16.92 10.20 28 119481 1804 29831165
Blood cholesterol increased 16.83 10.20 26 119483 16944 29816025
Gout 16.73 10.20 27 119482 17288 29815681
Haematochezia 16.62 10.20 75 119434 34147 29798822
Muscle spasticity 16.60 10.20 52 119457 5136 29827833
Transplant rejection 16.54 10.20 8 119501 9198 29823771
Vein collapse 16.43 10.20 7 119502 57 29832912
Transient ischaemic attack 16.34 10.20 49 119460 25151 29807818
Diabetic ketoacidosis 16.33 10.20 24 119485 15962 29817007
Acute myocardial infarction 16.27 10.20 134 119375 52805 29780164
Immune reconstitution inflammatory syndrome 16.21 10.20 8 119501 9093 29823876
Visceral congestion 16.17 10.20 15 119494 529 29832440
Sickle cell anaemia with crisis 16.17 10.20 32 119477 2370 29830599
Glomerular filtration rate decreased 16.10 10.20 13 119496 11349 29821620
Allodynia 16.06 10.20 16 119493 617 29832352
Abdominal pain 16.06 10.20 678 118831 134976 29697993
Dependence 15.97 10.20 22 119487 1204 29831765
Swelling of eyelid 15.49 10.20 12 119497 329 29832640
Asthma 15.43 10.20 83 119426 36091 29796878
Hypertensive crisis 15.42 10.20 7 119502 8350 29824619
Substance dependence 15.42 10.20 13 119496 403 29832566
Post laminectomy syndrome 15.38 10.20 10 119499 206 29832763
Substance use disorder 15.33 10.20 8 119501 107 29832862
Cluster headache 15.31 10.20 15 119494 567 29832402
Decerebration 15.30 10.20 5 119504 17 29832952
Diabetes mellitus 15.24 10.20 101 119408 41764 29791205
Injection site swelling 15.22 10.20 8 119501 8772 29824197
Accidental poisoning 15.18 10.20 14 119495 490 29832479
Photosensitivity reaction 15.16 10.20 10 119499 9684 29823285
Ischaemic stroke 15.15 10.20 26 119483 16249 29816720
Prescribed underdose 15.12 10.20 6 119503 7753 29825216
Apnoeic attack 14.96 10.20 11 119498 278 29832691
Infusion site granuloma 14.89 10.20 4 119505 5 29832964
Hypercapnia 14.79 10.20 41 119468 3783 29829186
Intensive care 14.73 10.20 11 119498 285 29832684
Electrocardiogram low voltage 14.67 10.20 5 119504 20 29832949
Nerve injury 14.66 10.20 35 119474 2948 29830021
Schizophrenia 14.60 10.20 9 119500 9039 29823930
Infective pulmonary exacerbation of cystic fibrosis 14.58 10.20 8 119501 8564 29824405
Accidental exposure to product by child 14.58 10.20 24 119485 1539 29831430
Salivary hypersecretion 14.50 10.20 6 119503 7560 29825409
Encephalopathy 14.43 10.20 194 119315 32011 29800958
Cerebrospinal fluid leakage 14.43 10.20 13 119496 441 29832528
Blood triglycerides increased 14.36 10.20 21 119488 13996 29818973
Metastases to lung 14.32 10.20 66 119443 7829 29825140
Carcinoid crisis 14.27 10.20 10 119499 234 29832735
Haemophagocytic lymphohistiocytosis 14.13 10.20 11 119498 9780 29823189
Intentional misuse of drug delivery system 14.09 10.20 4 119505 7 29832962
Psychomotor skills impaired 14.09 10.20 27 119482 1952 29831017
Depression 14.07 10.20 265 119244 90172 29742797
Victim of homicide 13.96 10.20 8 119501 130 29832839
Myopathy 13.92 10.20 13 119496 10573 29822396
Cerebral infarction 13.91 10.20 56 119453 26317 29806652
Disability 13.88 10.20 44 119465 4374 29828595
Rash 13.87 10.20 625 118884 191264 29641705
Incoherent 13.85 10.20 42 119467 4076 29828893
C-reactive protein increased 13.83 10.20 109 119400 43364 29789605
Tooth injury 13.82 10.20 16 119493 734 29832235
Condition aggravated 13.75 10.20 432 119077 137434 29695535
Medical device site bruise 13.75 10.20 4 119505 8 29832961
Arrhythmia neonatal 13.58 10.20 3 119506 0 29832969
Opiates 13.58 10.20 3 119506 0 29832969
Medical device site haemorrhage 13.54 10.20 8 119501 138 29832831
Multiple sclerosis relapse 13.52 10.20 14 119495 10848 29822121
Biliary obstruction 13.39 10.20 30 119479 2423 29830546
White blood cell count decreased 13.37 10.20 245 119264 83702 29749267
Therapy cessation 13.35 10.20 25 119484 15112 29817857
Infusion site urticaria 13.26 10.20 7 119502 96 29832873
Blood creatinine increased 13.23 10.20 271 119238 91104 29741865
Monocytopenia 13.19 10.20 7 119502 97 29832872
Tuberculosis 13.08 10.20 8 119501 8069 29824900
Acute pulmonary oedema 13.03 10.20 62 119447 7453 29825516
Brain injury 12.88 10.20 50 119459 5498 29827471
Small intestinal obstruction 12.86 10.20 96 119413 13563 29819406
Accidental underdose 12.80 10.20 11 119498 350 29832619
Neutrophil count decreased 12.80 10.20 108 119401 42346 29790623
Product residue present 12.71 10.20 31 119478 2647 29830322
Eosinophilic myocarditis 12.66 10.20 12 119497 435 29832534
Dyspnoea exertional 12.64 10.20 86 119423 35344 29797625
Head injury 12.61 10.20 31 119478 16989 29815980
Pulmonary haemorrhage 12.50 10.20 72 119437 9320 29823649
Drug intolerance 12.43 10.20 118 119391 45173 29787796
Blood pH increased 12.42 10.20 15 119494 720 29832249
Pupils unequal 12.39 10.20 20 119489 1262 29831707
Visual impairment 12.35 10.20 71 119438 30367 29802602
Nephrotic syndrome 12.35 10.20 6 119503 6879 29826090
Proteinuria 12.28 10.20 29 119480 16116 29816853
Cheyne-Stokes respiration 12.22 10.20 9 119500 228 29832741
Palpitations 12.22 10.20 81 119428 33492 29799477
Dyspepsia 12.16 10.20 71 119438 30258 29802711
Injection site reaction 12.16 10.20 15 119494 10745 29822224
Needle track marks 12.15 10.20 4 119505 14 29832955
Dose calculation error 12.15 10.20 5 119504 37 29832932
Necrotising colitis 11.95 10.20 17 119492 959 29832010
Parathyroid hormone-related protein abnormal 11.94 10.20 4 119505 15 29832954
Brain death 11.88 10.20 29 119480 2477 29830492
Paraparesis 11.85 10.20 24 119485 1807 29831162
Large intestine perforation 11.76 10.20 61 119448 7590 29825379
Hypercholesterolaemia 11.64 10.20 8 119501 7584 29825385
Respiratory rate increased 11.64 10.20 68 119441 8847 29824122
Mydriasis 11.63 10.20 52 119457 6091 29826878
Disorientation 11.60 10.20 183 119326 31235 29801734
Haemorrhagic stroke 11.58 10.20 5 119504 6142 29826827
Hypersensitivity 11.56 10.20 149 119360 53879 29779090
Intervertebral disc injury 11.55 10.20 4 119505 17 29832952
Lactic acidosis 11.51 10.20 75 119434 31138 29801831
Exposure during pregnancy 11.46 10.20 12 119497 9249 29823720
Peripheral swelling 11.44 10.20 173 119336 60901 29772068
COVID-19 11.42 10.20 35 119474 17843 29815126
Blood count abnormal 11.41 10.20 18 119491 11634 29821335
Secondary adrenocortical insufficiency 11.41 10.20 17 119492 1000 29831969
Foaming at mouth 11.31 10.20 14 119495 689 29832280
Perineal pain 11.30 10.20 13 119496 592 29832377
Cyanosis 11.30 10.20 84 119425 11851 29821118
Eosinophil count increased 11.29 10.20 8 119501 7465 29825504
Nasopharyngitis 11.26 10.20 166 119343 58683 29774286
Injection site erythema 11.21 10.20 24 119485 13810 29819159
Narcotic bowel syndrome 11.21 10.20 7 119502 134 29832835
Liver disorder 11.18 10.20 71 119438 29651 29803318
Cataract 11.12 10.20 47 119462 21788 29811181
Pupillary reflex impaired 11.03 10.20 21 119488 1511 29831458
Scan gallium abnormal 11.03 10.20 4 119505 20 29832949
Jaundice 11.02 10.20 80 119429 32406 29800563
Herpes zoster 11.02 10.20 72 119437 29871 29803098
Needle issue 10.99 10.20 37 119472 3795 29829174
Anamnestic reaction 10.94 10.20 5 119504 49 29832920
Conjunctival discolouration 10.87 10.20 4 119505 21 29832948
Paraplegia 10.76 10.20 29 119480 2632 29830337
Device computer issue 10.71 10.20 4 119505 22 29832947
Neuralgia 10.68 10.20 75 119434 10391 29822578
Synovitis 10.68 10.20 14 119495 9769 29823200
Tachyphylaxis 10.66 10.20 6 119503 94 29832875
Apparent life threatening event 10.59 10.20 8 119501 211 29832758
Infusion related reaction 10.58 10.20 107 119402 40457 29792512
Loss of personal independence in daily activities 10.57 10.20 47 119462 21488 29811481
Blood pressure diastolic decreased 10.51 10.20 51 119458 6180 29826789
Cardiac disorder 10.50 10.20 105 119404 39788 29793181
Medical device site infection 10.46 10.20 8 119501 215 29832754
Abdominal pain upper 10.45 10.20 181 119328 62370 29770599
Wrong technique in product usage process 10.44 10.20 77 119432 31078 29801891
Prostate cancer metastatic 10.44 10.20 44 119465 5023 29827946
General physical health deterioration 10.38 10.20 493 119016 99451 29733518
Renal failure 10.36 10.20 415 119094 128551 29704418
Ventricular asystole 10.32 10.20 7 119502 155 29832814
Performance status decreased 10.30 10.20 37 119472 3920 29829049
Learning disability 10.28 10.20 7 119502 156 29832813

Pharmacologic Action:

SourceCodeDescription
ATC N02AA01 NERVOUS SYSTEM
ANALGESICS
OPIOIDS
Natural opium alkaloids
ATC A07DA52 ALIMENTARY TRACT AND METABOLISM
ANTIDIARRHEALS, INTESTINAL ANTIINFLAMMATORY/ANTIINFECTIVE AGENTS
ANTIPROPULSIVES
Antipropulsives
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
FDA MoA N0000175684 Full Opioid Agonists
FDA EPC N0000175690 Opioid Agonist
MeSH PA D000700 Analgesics
MeSH PA D000701 Analgesics, Opioid
MeSH PA D002491 Central Nervous System Agents
MeSH PA D002492 Central Nervous System Depressants
MeSH PA D009294 Narcotics
MeSH PA D018373 Peripheral Nervous System Agents
MeSH PA D018689 Sensory System Agents
CHEBI has role CHEBI:35482 narcotic analgesics
CHEBI has role CHEBI:35620 vasodilator
CHEBI has role CHEBI:35703 xenobiotic
CHEBI has role CHEBI:38867 anaesthetic
CHEBI has role CHEBI:55322 mu opioid agonist
CHEBI has role CHEBI:76924 plant metabolites
CHEBI has role CHEBI:78298 environmental contaminants
CHEBI has role CHEBI:88188 allergenic drug

Drug Use (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

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)

None

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
15MG MORPHINE SULFATE ALKEM LABS LTD A212451 Dec. 3, 2020 RX TABLET ORAL Aug. 10, 2021 COMPETITIVE GENERIC THERAPY
30MG MORPHINE SULFATE ALKEM LABS LTD A212451 Dec. 3, 2020 RX TABLET ORAL Aug. 10, 2021 COMPETITIVE GENERIC THERAPY

Bioactivity Summary:

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

External reference:

IDSource
D00842 KEGG_DRUG
52-26-6 SECONDARY_CAS_RN
4017470 VANDF
4017530 VANDF
C0026549 UMLSCUI
CHEBI:17303 CHEBI
MOI PDB_CHEM_ID
CHEMBL70 ChEMBL_ID
CHEMBL556578 ChEMBL_ID
CHEMBL2103744 ChEMBL_ID
CHEMBL2096625 ChEMBL_ID
D009020 MESH_DESCRIPTOR_UI
DB00295 DRUGBANK_ID
1627 IUPHAR_LIGAND_ID
76I7G6D29C UNII
5288826 PUBCHEM_CID
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 0054-0238 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 0054-0517 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 0228-3090 CAPSULE, EXTENDED RELEASE 30 mg ORAL ANDA 34 sections
Morphine sulfate HUMAN PRESCRIPTION DRUG LABEL 1 0228-3091 CAPSULE, EXTENDED RELEASE 60 mg ORAL ANDA 34 sections
Morphine sulfate HUMAN PRESCRIPTION DRUG LABEL 1 0228-3092 CAPSULE, EXTENDED RELEASE 90 mg ORAL ANDA 34 sections
Morphine sulfate HUMAN PRESCRIPTION DRUG LABEL 1 0228-3093 CAPSULE, EXTENDED RELEASE 120 mg ORAL ANDA 34 sections
Morphine sulfate HUMAN PRESCRIPTION DRUG LABEL 1 0228-3116 CAPSULE, EXTENDED RELEASE 45 mg ORAL ANDA 34 sections
Morphine sulfate HUMAN PRESCRIPTION DRUG LABEL 1 0228-3117 CAPSULE, EXTENDED RELEASE 75 mg ORAL ANDA 34 sections