morphine 🐶 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 µM/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 6611.40 9.57 6593 209156 304094 62969179
Drug abuse 1097.64 9.57 1292 214457 71226 63202047
Toxicity to various agents 956.42 9.57 2392 213357 244858 63028415
Sedation 475.19 9.57 622 215127 38187 63235086
Depressed level of consciousness 467.49 9.57 792 214957 61286 63211987
Overdose 453.96 9.57 1123 214626 113955 63159318
Death 446.98 9.57 2474 213275 371907 62901366
Respiratory depression 443.40 9.57 370 215379 13345 63259928
Constipation 395.91 9.57 1663 214086 223280 63049993
Respiratory arrest 382.35 9.57 512 215237 32133 63241140
Sedation complication 374.25 9.57 337 215412 13485 63259788
Creatinine renal clearance decreased 350.68 9.57 350 215399 15958 63257315
Accidental overdose 343.53 9.57 410 215339 22899 63250374
Drug dependence 299.03 9.57 392 215357 24091 63249182
Miosis 294.57 9.57 225 215524 7128 63266145
Alopecia 281.82 9.57 445 215304 337091 62936182
Systemic lupus erythematosus 278.14 9.57 184 215565 208734 63064539
Blood calcium decreased 266.61 9.57 386 215363 26065 63247208
Pemphigus 262.39 9.57 149 215600 183577 63089696
Coma 241.96 9.57 617 215132 63747 63209526
Somnolence 237.92 9.57 1218 214531 177467 63095806
Glossodynia 234.76 9.57 160 215589 178716 63094557
Orthostatic hypotension 231.71 9.57 430 215319 35730 63237543
Completed suicide 209.46 9.57 1015 214734 144658 63128615
Hypotension 205.67 9.57 1607 214142 270997 63002276
Cardiac arrest 201.31 9.57 732 215017 91813 63181460
Arthropathy 201.10 9.57 304 215445 234488 63038785
Bradypnoea 200.72 9.57 134 215615 3416 63269857
Abdominal discomfort 199.05 9.57 503 215246 320382 62952891
Drug withdrawal syndrome 191.57 9.57 337 215412 26857 63246416
Vomiting 179.85 9.57 2782 212967 556835 62716438
Cardio-respiratory arrest 171.18 9.57 520 215229 59439 63213834
Contrast media allergy 168.89 9.57 104 215645 2297 63270976
Cognitive disorder 164.95 9.57 490 215259 55325 63217948
Unresponsive to stimuli 161.60 9.57 356 215393 33460 63239813
Respiratory rate decreased 156.82 9.57 115 215634 3420 63269853
Hand deformity 155.15 9.57 188 215561 159269 63114004
Substance abuse 153.94 9.57 129 215620 4678 63268595
Macular degeneration 152.57 9.57 287 215462 24089 63249184
Swelling 141.94 9.57 471 215278 274907 62998366
Hyperaesthesia 141.82 9.57 167 215582 9191 63264082
Folliculitis 136.82 9.57 35 215714 70282 63202991
Balance disorder 135.04 9.57 607 215142 83815 63189458
Product dose omission issue 131.15 9.57 386 215363 233927 63039346
Maternal exposure during delivery 126.42 9.57 73 215676 1427 63271846
Muscle injury 122.47 9.57 35 215714 65310 63207963
Pericarditis 121.87 9.57 161 215588 131418 63141855
Fatigue 118.93 9.57 2216 213533 885812 62387461
Arthralgia 115.63 9.57 1309 214440 568401 62704872
Intestinal pseudo-obstruction 115.01 9.57 58 215691 854 63272419
Myoclonus 114.82 9.57 199 215550 15669 63257604
Irritable bowel syndrome 114.50 9.57 69 215680 82343 63190930
Inadequate analgesia 111.22 9.57 87 215662 2856 63270417
Sinusitis 109.77 9.57 398 215351 226255 63047018
Anti-cyclic citrullinated peptide antibody positive 107.82 9.57 142 215607 116070 63157203
Wound 105.73 9.57 250 215499 163013 63110260
Device expulsion 104.67 9.57 3 215746 34919 63238354
Poisoning 104.65 9.57 176 215573 13524 63259749
Duodenal ulcer perforation 104.06 9.57 86 215663 87123 63186150
Ill-defined disorder 100.83 9.57 78 215671 81677 63191596
Exposure via ingestion 99.27 9.57 81 215668 2828 63270445
Drug ineffective 98.09 9.57 2755 212994 1042010 62231263
Sleep disorder due to general medical condition, insomnia type 97.80 9.57 28 215721 52189 63221084
Weight increased 96.42 9.57 507 215242 260285 63012988
COVID-19 96.20 9.57 147 215602 112956 63160317
Poisoning deliberate 95.00 9.57 151 215598 11067 63262206
Helicobacter infection 93.85 9.57 106 215643 92679 63180594
Mental status changes 93.59 9.57 322 215427 39277 63233996
Malignant neoplasm progression 91.76 9.57 534 215215 81587 63191686
Off label use 91.01 9.57 1680 214069 672782 62600491
Asphyxia 88.23 9.57 107 215642 6074 63267199
Gastrointestinal disorder 88.16 9.57 197 215552 131042 63142231
Hypoxia 86.82 9.57 418 215331 59374 63213899
Contraindicated product administered 86.80 9.57 412 215337 217236 63056037
Impaired healing 86.51 9.57 134 215615 102408 63170865
Discomfort 84.97 9.57 288 215461 167086 63106187
Drug abuser 84.55 9.57 74 215675 2849 63270424
White blood cell count abnormal 84.17 9.57 105 215644 6137 63267136
Drug screen positive 83.81 9.57 81 215668 3548 63269725
Nasopharyngitis 83.35 9.57 514 215235 253743 63019530
Soft tissue disorder 82.58 9.57 88 215661 4334 63268939
Delirium 81.24 9.57 364 215385 50177 63223096
Mobility decreased 80.78 9.57 695 215054 120464 63152809
Apnoea 80.72 9.57 117 215632 7905 63265368
Retinitis 80.01 9.57 102 215647 6094 63267179
Injection site erythema 79.86 9.57 99 215650 83075 63190198
Drug diversion 79.53 9.57 46 215703 902 63272371
Maternal exposure during pregnancy 78.45 9.57 433 215316 219629 63053644
Hallucination 77.99 9.57 381 215368 54436 63218837
Acute chest syndrome 77.41 9.57 43 215706 778 63272495
Anterior spinal artery syndrome 77.30 9.57 25 215724 100 63273173
Intentional product misuse 75.93 9.57 408 215341 60509 63212764
Respiratory failure 71.45 9.57 591 215158 101267 63172006
Rash 68.86 9.57 1419 214330 559452 62713821
Abortion spontaneous 67.70 9.57 38 215711 47157 63226116
Contusion 63.99 9.57 277 215472 149767 63123506
Blister 62.76 9.57 228 215521 129586 63143687
Injection site pain 62.74 9.57 228 215521 129572 63143701
Dilatation intrahepatic duct acquired 62.15 9.57 35 215714 651 63272622
Aspiration 62.07 9.57 123 215626 10728 63262545
Acidosis 60.28 9.57 124 215625 11109 63262164
Urinary retention 60.28 9.57 233 215516 30068 63243205
Injection site reaction 60.12 9.57 66 215683 58458 63214815
Nausea 59.41 9.57 3506 212243 850965 62422308
Hypercapnia 57.27 9.57 81 215668 5350 63267923
Joint swelling 56.81 9.57 778 214971 326888 62946385
Obliterative bronchiolitis 56.54 9.57 51 215698 2044 63271229
Withdrawal syndrome 55.71 9.57 172 215577 19825 63253448
Injection site pruritus 53.18 9.57 45 215704 45071 63228202
Injection site swelling 53.02 9.57 50 215699 47522 63225751
Sphincter of Oddi dysfunction 51.97 9.57 26 215723 376 63272897
Peripheral swelling 51.82 9.57 616 215133 265326 63007947
Condition aggravated 51.25 9.57 1011 214738 401206 62872067
Hepatic enzyme increased 50.85 9.57 441 215308 201887 63071386
Abdominal pain 50.76 9.57 1331 214418 292125 62981148
Vaginal flatulence 50.28 9.57 59 215690 3234 63270039
Bone erosion 49.92 9.57 153 215596 17564 63255709
Drug withdrawal syndrome neonatal 49.10 9.57 47 215702 2034 63271239
Anaphylactic reaction 47.67 9.57 386 215363 65714 63207559
Lethargy 47.07 9.57 339 215410 55668 63217605
Narcotic bowel syndrome 46.32 9.57 18 215731 135 63273138
Respiratory acidosis 45.72 9.57 82 215667 6633 63266640
Product use issue 45.20 9.57 505 215244 220015 63053258
Therapeutic product effect decreased 44.67 9.57 430 215319 192757 63080516
Exostosis 44.63 9.57 148 215601 17714 63255559
Gangrene 44.57 9.57 77 215672 6046 63267227
Joint dislocation 44.53 9.57 153 215596 18647 63254626
Neutropenic sepsis 44.51 9.57 140 215609 16298 63256975
Visceral congestion 43.98 9.57 22 215727 318 63272955
Cardiac failure congestive 43.58 9.57 164 215585 92269 63181004
Pregnancy 43.10 9.57 37 215712 36799 63236474
Nasal congestion 42.91 9.57 100 215649 65560 63207713
Cholestasis 40.73 9.57 203 215546 29231 63244042
Diarrhoea 40.53 9.57 2003 213746 713363 62559910
Radiculopathy 40.39 9.57 90 215659 8521 63264752
Female genital tract fistula 40.04 9.57 83 215666 7476 63265797
Confusional state 39.94 9.57 1069 214680 235311 63037962
Psoriatic arthropathy 39.59 9.57 168 215581 91352 63181921
No adverse event 37.97 9.57 51 215698 41354 63231919
Colitis microscopic 37.66 9.57 92 215657 9247 63264026
Synovitis 37.14 9.57 431 215318 186487 63086786
Pulseless electrical activity 36.85 9.57 80 215669 7441 63265832
Rhythm idioventricular 36.75 9.57 18 215731 248 63273025
Proctitis 36.48 9.57 66 215683 5375 63267898
Accidental death 36.33 9.57 39 215710 1937 63271336
Hypersensitivity 35.65 9.57 741 215008 291944 62981329
Ventilation perfusion mismatch 35.32 9.57 22 215727 496 63272777
Iodine allergy 35.31 9.57 26 215723 778 63272495
Agitation 35.31 9.57 334 215415 59423 63213850
Oxygen saturation decreased 34.87 9.57 457 215292 88128 63185145
Stomatitis 34.55 9.57 303 215446 138422 63134851
Cough 34.52 9.57 745 215004 291998 62981275
Sepsis 34.27 9.57 720 215029 152403 63120870
Foetal megacystis 34.16 9.57 10 215739 26 63273247
Plasma cell myeloma 34.12 9.57 224 215525 35681 63237592
Accidental exposure to product by child 34.10 9.57 30 215719 1163 63272110
Hepatic cirrhosis 33.81 9.57 170 215579 24564 63248709
Mucosal inflammation 33.81 9.57 274 215475 46654 63226619
Injection site rash 33.57 9.57 11 215738 18798 63254475
Hospitalisation 33.32 9.57 162 215587 84919 63188354
Intentional product use issue 32.90 9.57 277 215472 127615 63145658
Skin candida 32.80 9.57 34 215715 1621 63271652
Therapy interrupted 31.81 9.57 38 215711 32417 63240856
Pancreatic fibrosis 31.35 9.57 12 215737 86 63273187
Wrong technique in product usage process 31.11 9.57 108 215641 62232 63211041
Tonsillar disorder 30.98 9.57 28 215721 1125 63272148
Spinal cord injury 30.76 9.57 25 215724 868 63272405
Brain oedema 30.59 9.57 112 215637 14083 63259190
Post procedural complication 30.52 9.57 127 215622 16947 63256326
Systemic mastocytosis 30.37 9.57 14 215735 167 63273106
Sopor 30.16 9.57 19 215730 22145 63251128
Pulmonary oedema 30.11 9.57 302 215447 54571 63218702
Arterial occlusive disease 29.91 9.57 64 215685 5894 63267379
Pneumonia viral 29.80 9.57 76 215673 7846 63265427
Dyspnoea exertional 29.73 9.57 105 215644 60197 63213076
Arthritis 29.24 9.57 555 215194 115366 63157907
Toxicologic test abnormal 28.74 9.57 22 215727 699 63272574
Pruritus allergic 28.69 9.57 31 215718 1551 63271722
Implant site extravasation 28.61 9.57 19 215730 480 63272793
Coronary artery disease 28.56 9.57 41 215708 32336 63240937
Treatment failure 28.51 9.57 490 215259 198553 63074720
Full blood count abnormal 28.14 9.57 40 215709 31677 63241596
Bradycardia 28.08 9.57 376 215373 72851 63200422
Dizziness 28.06 9.57 1185 214564 428740 62844533
Cyanosis 27.98 9.57 123 215626 16812 63256461
Rheumatoid factor positive 27.94 9.57 170 215579 84236 63189037
Procedural pain 27.92 9.57 146 215603 21423 63251850
Seronegative arthritis 27.79 9.57 49 215700 3910 63269363
Infusion related reaction 27.74 9.57 629 215120 244892 63028381
Transient ischaemic attack 27.58 9.57 54 215695 37699 63235574
Hypoxic-ischaemic encephalopathy 27.47 9.57 51 215698 4236 63269037
Heavy menstrual bleeding 27.43 9.57 13 215736 17760 63255513
Vaginal discharge 27.39 9.57 81 215668 9117 63264156
Sternal fracture 27.37 9.57 36 215713 2218 63271055
Alveolitis 27.15 9.57 41 215708 2874 63270399
Diffuse axonal injury 26.87 9.57 11 215738 96 63273177
Colitis 26.59 9.57 267 215482 48261 63225012
C-reactive protein abnormal 26.42 9.57 75 215674 46021 63227252
Femur fracture 26.16 9.57 65 215684 41691 63231582
Progressive multifocal leukoencephalopathy 26.12 9.57 6 215743 12965 63260308
Rheumatic fever 25.56 9.57 69 215680 43042 63230231
Drug tolerance 25.45 9.57 66 215683 6883 63266390
Skin reaction 25.42 9.57 109 215640 14740 63258533
Breast cancer metastatic 25.21 9.57 94 215655 11924 63261349
Encephalopathy 24.91 9.57 220 215529 38400 63234873
Allodynia 24.22 9.57 21 215728 798 63272475
Multiple sclerosis relapse 24.18 9.57 84 215665 48394 63224879
Laryngitis 24.17 9.57 118 215631 16849 63256424
Hip arthroplasty 24.14 9.57 82 215667 47564 63225709
Antinuclear antibody negative 24.12 9.57 13 215736 221 63273052
Vascular resistance systemic decreased 23.97 9.57 10 215739 92 63273181
Syncope 23.95 9.57 269 215480 117116 63156157
Pupillary reflex impaired 23.79 9.57 32 215717 2015 63271258
Small intestinal obstruction 23.65 9.57 124 215625 18213 63255060
Anaesthesia 23.59 9.57 16 215733 419 63272854
Administration site abscess 23.43 9.57 7 215742 20 63273253
Foetal monitoring abnormal 23.36 9.57 13 215736 236 63273037
Chronic spontaneous urticaria 23.35 9.57 24 215725 1133 63272140
Respiratory distress 23.26 9.57 196 215553 33755 63239518
Spinal epidural haemorrhage 23.24 9.57 10 215739 100 63273173
Excessive eye blinking 23.07 9.57 25 215724 1255 63272018
Foot deformity 23.06 9.57 168 215581 27685 63245588
Cardiac output decreased 23.02 9.57 22 215727 950 63272323
Administration site induration 22.71 9.57 7 215742 23 63273250
Pulmonary congestion 22.61 9.57 118 215631 17300 63255973
Breast cancer female 22.38 9.57 9 215740 13550 63259723
Lupus-like syndrome 22.24 9.57 107 215642 15188 63258085
Pupil fixed 22.14 9.57 29 215720 1780 63271493
Libido increased 22.05 9.57 25 215724 1320 63271953
Pulmonary toxicity 22.02 9.57 3 215746 9452 63263821
Incoherent 21.98 9.57 48 215701 4482 63268791
Interstitial lung disease 21.92 9.57 122 215627 61786 63211487
Dry skin 21.88 9.57 109 215640 56778 63216495
Therapy cessation 21.87 9.57 44 215705 30413 63242860
Administration site discharge 21.65 9.57 7 215742 28 63273245
Nervous system disorder 21.58 9.57 123 215626 18643 63254630
Tenosynovitis 21.43 9.57 10 215739 13785 63259488
Joint effusion 21.38 9.57 16 215733 17044 63256229
Spinal cord compression 21.33 9.57 45 215704 4103 63269170
Intentional self-injury 21.24 9.57 34 215715 25653 63247620
Impaired work ability 21.12 9.57 17 215732 17458 63255815
Headache 21.10 9.57 1859 213890 631382 62641891
Catheter site granuloma 21.10 9.57 5 215744 3 63273270
Personality disorder 21.09 9.57 55 215694 5756 63267517
Product quality issue 20.82 9.57 58 215691 35807 63237466
Total lung capacity decreased 20.75 9.57 31 215718 2152 63271121
Peripheral nerve injury 20.75 9.57 15 215734 436 63272837
Neuroendocrine tumour of the lung 20.66 9.57 6 215743 15 63273258
Gallbladder cholesterolosis 20.54 9.57 19 215730 787 63272486
Suicide attempt 20.52 9.57 122 215627 60796 63212477
Dependence 20.47 9.57 30 215719 2047 63271226
Eczema 20.44 9.57 50 215699 32241 63241032
Hypoventilation 20.43 9.57 48 215701 4706 63268567
Swollen joint count increased 20.42 9.57 59 215690 35995 63237278
Complex regional pain syndrome 20.33 9.57 32 215717 2325 63270948
Anaesthetic complication 20.32 9.57 29 215720 1931 63271342
Blood phosphorus decreased 20.28 9.57 46 215703 4407 63268866
Tendonitis 20.27 9.57 22 215727 19593 63253680
Breast cancer 20.20 9.57 90 215659 48293 63224980
Infective pulmonary exacerbation of cystic fibrosis 20.06 9.57 3 215746 8814 63264459
Hyperhidrosis 20.03 9.57 494 215255 107342 63165931
Urinary bladder rupture 20.03 9.57 10 215739 144 63273129
Bronchopulmonary aspergillosis allergic 19.96 9.57 31 215718 2227 63271046
Myalgia 19.93 9.57 364 215385 146165 63127108
Cardiac failure 19.92 9.57 200 215549 88942 63184331
Implant site discharge 19.90 9.57 10 215739 146 63273127
Metastases to bone 19.89 9.57 131 215618 20888 63252385
Administration site odour 19.48 9.57 7 215742 41 63273232
Metastases to eye 19.43 9.57 10 215739 154 63273119
Injection site warmth 19.37 9.57 14 215735 15181 63258092
Infection 19.35 9.57 612 215137 228561 63044712
Serotonin syndrome 19.34 9.57 165 215584 28517 63244756
Injection site bruising 19.33 9.57 75 215674 41835 63231438
Hepatocellular injury 19.25 9.57 159 215590 27222 63246051
Chronic kidney disease 19.22 9.57 84 215665 45314 63227959
Theft 19.14 9.57 8 215741 74 63273199
Product name confusion 19.14 9.57 8 215741 74 63273199
Faecaloma 19.13 9.57 65 215684 7876 63265397
Blood immunoglobulin A decreased 19.13 9.57 23 215726 1294 63271979
Knee arthroplasty 19.09 9.57 107 215642 54099 63219174
Device difficult to use 18.79 9.57 10 215739 12786 63260487
Calcium deficiency 18.77 9.57 21 215728 1093 63272180
Suspected product tampering 18.75 9.57 4 215745 0 63273273
Keratitis 18.63 9.57 38 215711 3384 63269889
Coombs positive haemolytic anaemia 18.59 9.57 13 215736 358 63272915
Basal ganglion degeneration 18.59 9.57 14 215735 434 63272839
Liver injury 18.44 9.57 125 215624 60395 63212878
Cardiopulmonary failure 18.36 9.57 39 215710 3573 63269700
Palpitations 18.35 9.57 271 215478 112499 63160774
Tissue infiltration 18.35 9.57 16 215733 613 63272660
Nasal disorder 18.26 9.57 34 215715 2830 63270443
Lung opacity 18.23 9.57 36 215713 3132 63270141
Dyspnoea 18.17 9.57 1969 213780 659344 62613929
Tachycardia 18.14 9.57 528 215221 117628 63155645
Blood pH decreased 18.14 9.57 32 215717 2555 63270718
Increased bronchial secretion 18.12 9.57 26 215723 1740 63271533
Disease recurrence 18.06 9.57 43 215706 27987 63245286
Myocardial infarction 18.06 9.57 235 215514 99658 63173615
Gastrooesophageal reflux disease 18.03 9.57 223 215526 95416 63177857
Polyarthritis 17.99 9.57 6 215743 10140 63263133
Clonus 17.99 9.57 45 215704 4591 63268682
Soft tissue injury 17.96 9.57 25 215724 1627 63271646
Injection site urticaria 17.89 9.57 13 215736 14060 63259213
Hypothermia 17.62 9.57 92 215657 13489 63259784
Asthma 17.62 9.57 316 215433 127245 63146028
Disease progression 17.62 9.57 544 215205 122214 63151059
Feeling jittery 17.54 9.57 12 215737 13391 63259882
Incubator therapy 17.52 9.57 7 215742 57 63273216
Congenital pulmonary hypertension 17.52 9.57 7 215742 57 63273216
Oral candidiasis 17.45 9.57 135 215614 22663 63250610
Schizophrenia 17.45 9.57 6 215743 9946 63263327
Sensory loss 17.41 9.57 75 215674 10163 63263110
Central nervous system injury 17.29 9.57 9 215740 142 63273131
Sleep disorder due to a general medical condition 17.21 9.57 10 215739 12178 63261095
Injection site discolouration 17.12 9.57 3 215746 7845 63265428
Patient uncooperative 17.03 9.57 10 215739 202 63273071
Hostility 16.97 9.57 26 215723 1846 63271427
Throat irritation 16.97 9.57 68 215681 37579 63235694
Aplastic anaemia 16.97 9.57 71 215678 9498 63263775
Lower respiratory tract infection 16.96 9.57 332 215417 131975 63141298
Breakthrough pain 16.86 9.57 21 215728 1225 63272048
Uveitis 16.75 9.57 11 215738 12542 63260731
Administration site haemorrhage 16.74 9.57 8 215741 104 63273169
Eye pain 16.65 9.57 59 215690 33795 63239478
Urticaria thermal 16.64 9.57 13 215736 426 63272847
Injection site cyst 16.63 9.57 7 215742 66 63273207
Abortion induced 16.58 9.57 7 215742 10235 63263038
Musculoskeletal stiffness 16.57 9.57 489 215260 184129 63089144
Flushing 16.55 9.57 169 215580 74918 63198355
Abnormal behaviour 16.47 9.57 127 215622 21299 63251974
Hypoacusis 16.41 9.57 36 215713 24115 63249158
Neuralgia 16.37 9.57 147 215602 25779 63247494
Hallucination, visual 16.32 9.57 117 215632 19181 63254092
Nodule 16.31 9.57 29 215720 20997 63252276
Foetal heart rate abnormal 16.20 9.57 15 215734 622 63272651
Sinus tachycardia 16.04 9.57 139 215610 24129 63249144
Vascular malformation 16.04 9.57 12 215737 368 63272905
Myelodysplastic syndrome 16.01 9.57 20 215729 16734 63256539
Toxic leukoencephalopathy 15.92 9.57 16 215733 735 63272538
Hallucination, tactile 15.89 9.57 11 215738 298 63272975
Blood alkaline phosphatase increased 15.80 9.57 219 215530 42748 63230525
Epidural haemorrhage 15.79 9.57 8 215741 119 63273154
Drug resistance 15.73 9.57 34 215715 22899 63250374
Disorientation 15.71 9.57 204 215545 39248 63234025
Respiratory tract infection 15.66 9.57 80 215669 41403 63231870
Back pain 15.65 9.57 1070 214679 263075 63010198
Cancer pain 15.60 9.57 34 215715 3171 63270102
Genital haemorrhage 15.57 9.57 3 215746 7329 63265944
Drug tolerance increased 15.54 9.57 10 215739 239 63273034
Antinuclear antibody positive 15.52 9.57 4 215745 7995 63265278
Pituitary apoplexy 15.44 9.57 8 215741 125 63273148
Skin cancer 15.44 9.57 10 215739 11485 63261788
Loss of personal independence in daily activities 15.41 9.57 235 215514 97055 63176218
Paranasal cyst 15.31 9.57 12 215737 395 63272878
Infusion site pain 15.24 9.57 21 215728 16848 63256425
Peptic ulcer perforation 15.23 9.57 9 215740 184 63273089
Fear-related avoidance of activities 15.22 9.57 8 215741 129 63273144
Epidural analgesia 15.22 9.57 6 215743 47 63273226
Weaning failure 15.21 9.57 12 215737 399 63272874
Liver function test abnormal 15.14 9.57 239 215510 47942 63225331
Cerebrovascular accident 15.11 9.57 267 215482 107757 63165516
Transplant rejection 15.00 9.57 9 215740 10771 63262502
Post-traumatic neck syndrome 14.99 9.57 26 215723 2048 63271225
Coma scale abnormal 14.99 9.57 45 215704 5108 63268165
Tubulointerstitial nephritis 14.95 9.57 28 215721 19875 63253398
Muscle twitching 14.80 9.57 116 215633 19552 63253721
Myopathy 14.67 9.57 10 215739 11181 63262092
Chronic sinusitis 14.65 9.57 84 215665 12759 63260514
Dry eye 14.61 9.57 80 215669 40681 63232592
Deformity 14.59 9.57 11 215738 11673 63261600
Substance use 14.56 9.57 13 215736 514 63272759
Terminal state 14.44 9.57 27 215722 2255 63271018
Stroke volume increased 14.38 9.57 4 215745 8 63273265
Liver disorder 14.38 9.57 115 215634 53572 63219701
Hepatic function abnormal 14.38 9.57 71 215678 37071 63236202
Suspected suicide 14.30 9.57 52 215697 6516 63266757
Night sweats 14.29 9.57 102 215647 48712 63224561
Rheumatic disorder 14.29 9.57 32 215717 3040 63270233
Blood pressure diastolic abnormal 14.28 9.57 17 215732 14525 63258748
Neuromuscular block prolonged 14.25 9.57 13 215736 529 63272744
Documented hypersensitivity to administered product 14.19 9.57 13 215736 532 63272741
Product storage error 14.14 9.57 18 215731 14938 63258335
Infusion site granuloma 14.06 9.57 3 215746 0 63273273
Agonal death struggle 14.06 9.57 3 215746 0 63273273
Breath sounds abnormal 14.01 9.57 74 215675 10899 63262374
White blood cell count decreased 13.88 9.57 363 215386 138741 63134532
Thymus disorder 13.82 9.57 10 215739 291 63272982
Pleuritic pain 13.79 9.57 59 215690 7970 63265303
PO2 decreased 13.77 9.57 21 215728 1485 63271788
Temperature regulation disorder 13.74 9.57 49 215700 6083 63267190
Herpes simplex reactivation 13.73 9.57 13 215736 555 63272718
Infusion 13.69 9.57 8 215741 160 63273113
Pemphigoid 13.63 9.57 4 215745 7340 63265933
Carcinoid tumour 13.58 9.57 11 215738 380 63272893
Spinal cord paralysis 13.54 9.57 5 215744 32 63273241
Onychomycosis 13.53 9.57 5 215744 7927 63265346
Blood immunoglobulin M increased 13.49 9.57 18 215731 1125 63272148
Posterior reversible encephalopathy syndrome 13.44 9.57 103 215646 17242 63256031
Atrial fibrillation 13.38 9.57 298 215451 116338 63156935
Dysphagia 13.36 9.57 395 215354 88190 63185083
Blood calcium increased 13.30 9.57 65 215684 9285 63263988
Hypohidrosis 13.29 9.57 6 215743 68 63273205
Retrograde amnesia 13.16 9.57 12 215737 488 63272785
Neuroblastoma 12.98 9.57 6 215743 72 63273201
Hyperreflexia 12.94 9.57 47 215702 5887 63267386
Muscle spasms 12.93 9.57 418 215331 155732 63117541
Ear pain 12.88 9.57 71 215678 36047 63237226
Mydriasis 12.86 9.57 77 215672 11879 63261394
Occupational dermatitis 12.81 9.57 5 215744 38 63273235
Suicidal ideation 12.75 9.57 143 215606 62278 63210995
Skin fissures 12.65 9.57 12 215737 11376 63261897
Rhinitis 12.60 9.57 12 215737 11354 63261919
Iron deficiency anaemia 12.58 9.57 31 215718 19938 63253335
Wheezing 12.52 9.57 239 215510 95356 63177917
Laboratory test abnormal 12.52 9.57 48 215701 26864 63246409
Neuroblastoma recurrent 12.49 9.57 6 215743 79 63273194
Myoglobin urine 12.37 9.57 4 215745 16 63273257
Aspergillus infection 12.37 9.57 6 215743 8087 63265186
Rhinitis allergic 12.29 9.57 13 215736 11714 63261559
Withdrawal catatonia 12.17 9.57 6 215743 84 63273189
Myocardial fibrosis 12.07 9.57 14 215735 758 63272515
Livedo reticularis 12.07 9.57 26 215723 2406 63270867
Metastasis 12.05 9.57 42 215707 5155 63268118
Metastases to spine 12.05 9.57 31 215718 3218 63270055
Uterine enlargement 12.04 9.57 18 215731 1250 63272023
Implant site infection 12.01 9.57 16 215733 998 63272275
Type 2 diabetes mellitus 12.01 9.57 149 215600 63719 63209554
Analgesic therapy 11.99 9.57 3 215746 3 63273270
Chronic idiopathic pain syndrome 11.99 9.57 3 215746 3 63273270
Nail disorder 11.96 9.57 16 215733 12999 63260274
Muscle tension dysphonia 11.91 9.57 8 215741 206 63273067
Red blood cell count decreased 11.86 9.57 85 215664 40560 63232713
Pleural effusion 11.81 9.57 407 215342 92803 63180470
Sickle cell anaemia with crisis 11.81 9.57 46 215703 5957 63267316
Intestinal strangulation 11.80 9.57 6 215743 90 63273183
Splenic injury 11.71 9.57 8 215741 212 63273061
Product selection error 11.68 9.57 6 215743 92 63273181
Impaired quality of life 11.63 9.57 18 215731 13765 63259508
Accidental underdose 11.62 9.57 14 215735 789 63272484
Denture wearer 11.58 9.57 8 215741 216 63273057
Pathological fracture 11.57 9.57 60 215689 8774 63264499
COVID-19 pneumonia 11.57 9.57 19 215730 14190 63259083
Neoplasm progression 11.56 9.57 181 215568 36247 63237026
Hip surgery 11.55 9.57 31 215718 3300 63269973
Amenorrhoea 11.55 9.57 10 215739 9904 63263369
Brain injury 11.52 9.57 51 215698 6992 63266281
Cardiac death 11.49 9.57 12 215737 577 63272696
Haematotoxicity 11.49 9.57 9 215740 9367 63263906
Asthenia 11.47 9.57 1135 214614 382469 62890804
Influenza like illness 11.42 9.57 159 215590 66665 63206608
Pharyngitis 11.38 9.57 33 215716 20110 63253163
Incision site swelling 11.36 9.57 8 215741 223 63273050
Acute kidney injury 11.34 9.57 1041 214708 262374 63010899
Monoplegia 11.31 9.57 30 215719 3171 63270102
Adiposis dolorosa 11.28 9.57 9 215740 304 63272969
Sleep disorder 11.28 9.57 202 215547 81364 63191909
Ischaemic stroke 11.21 9.57 28 215721 17929 63255344
Intestinal obstruction 11.16 9.57 157 215592 30742 63242531
Nephrostomy 11.13 9.57 6 215743 102 63273171
Injection site induration 11.12 9.57 9 215740 9217 63264056
Respiratory rate increased 11.11 9.57 82 215667 13566 63259707
Product dose omission in error 11.10 9.57 6 215743 7606 63265667
Colorectal cancer metastatic 11.10 9.57 12 215737 601 63272672
Postoperative ileus 11.06 9.57 11 215738 499 63272774
Anaesthetic complication pulmonary 11.05 9.57 5 215744 57 63273216
Lupus vulgaris 11.04 9.57 45 215704 5949 63267324
Surgery 11.02 9.57 74 215675 35838 63237435
Heat stroke 11.01 9.57 14 215735 834 63272439
Menstruation irregular 11 9.57 5 215744 6999 63266274
Pharyngitis streptococcal 11.00 9.57 12 215737 10660 63262613
Gastritis fungal 10.93 9.57 6 215743 106 63273167
Laryngectomy 10.91 9.57 4 215745 25 63273248
Hepatitis fulminant 10.79 9.57 31 215718 3433 63269840
Buttock injury 10.79 9.57 8 215741 242 63273031
Bone marrow failure 10.76 9.57 57 215692 29233 63244040
Multiple drug therapy 10.75 9.57 32 215717 3614 63269659
Dehydration 10.75 9.57 705 215044 172649 63100624
Foetal arrhythmia 10.71 9.57 7 215742 172 63273101
Granulocytopenia 10.70 9.57 3 215746 5669 63267604
Device issue 10.69 9.57 43 215706 23738 63249535
Metastases to oesophagus 10.65 9.57 4 215745 27 63273246
Tinnitus 10.65 9.57 74 215675 35554 63237719
Intraventricular haemorrhage neonatal 10.64 9.57 7 215742 174 63273099
Neurodevelopmental disorder 10.64 9.57 7 215742 174 63273099
Gastrointestinal haemorrhage 10.61 9.57 203 215546 80973 63192300
Symptom masked 10.61 9.57 13 215736 746 63272527
Paraesthesia oral 10.57 9.57 106 215643 19150 63254123
Haemangioma of skin 10.56 9.57 10 215739 427 63272846
Stridor 10.54 9.57 31 215718 3479 63269794
Thrombocytopenia 10.53 9.57 621 215128 150536 63122737
Administration site erythema 10.52 9.57 13 215736 752 63272521
Blood glucose increased 10.48 9.57 211 215538 83545 63189728
Thyroxine decreased 10.47 9.57 12 215737 641 63272632
Cardiac murmur 10.47 9.57 21 215728 14531 63258742
Vulvovaginal candidiasis 10.46 9.57 29 215720 3146 63270127
Inappropriate schedule of product administration 10.45 9.57 271 215478 103694 63169579
Delayed recovery from anaesthesia 10.44 9.57 13 215736 758 63272515
Adverse event 10.42 9.57 164 215585 67395 63205878
Vertigo 10.41 9.57 142 215607 59745 63213528
Tooth hypoplasia 10.40 9.57 5 215744 66 63273207
Hiatus hernia 10.38 9.57 38 215711 21556 63251717
Carcinoid crisis 10.35 9.57 8 215741 258 63273015
Abdominal hernia 10.34 9.57 39 215710 4973 63268300
Spleen congestion 10.31 9.57 6 215743 119 63273154
Infrequent bowel movements 10.31 9.57 17 215732 1285 63271988
Eye swelling 10.28 9.57 44 215705 23874 63249399
Urinary tract obstruction 10.27 9.57 23 215726 2185 63271088
Squamous cell carcinoma of skin 10.24 9.57 4 215745 6128 63267145
Renal cyst 10.23 9.57 65 215684 10237 63263036
Therapeutic product effect prolonged 10.21 9.57 9 215740 350 63272923
Pocket erosion 10.19 9.57 3 215746 8 63273265
Urticaria aquagenic 10.18 9.57 4 215745 31 63273242
Hypertension 10.15 9.57 814 214935 278489 62994784
Brain death 10.13 9.57 30 215719 3380 63269893
Non-small cell lung cancer 10.08 9.57 31 215718 3564 63269709
Upper respiratory tract infection 10.08 9.57 357 215392 81690 63191583
Urticaria cholinergic 10.07 9.57 4 215745 32 63273241
Mastoiditis 10.05 9.57 15 215734 1040 63272233
Neutropenia 10.03 9.57 489 215260 174516 63098757
Hypercreatininaemia 10.03 9.57 11 215738 560 63272713
Urinary tract infection 9.99 9.57 769 214980 263915 63009358
Cytomegalovirus infection 9.98 9.57 37 215712 20915 63252358
Nasal polyps 9.98 9.57 4 215745 6035 63267238
C-reactive protein increased 9.94 9.57 405 215344 94302 63178971
Thirst decreased 9.89 9.57 8 215741 276 63272997
Erysipelas 9.88 9.57 53 215696 7852 63265421
Joint range of motion decreased 9.86 9.57 67 215682 32361 63240912
Atypical femur fracture 9.84 9.57 3 215746 5369 63267904
Sepsis neonatal 9.83 9.57 10 215739 466 63272807
Haemophagocytic lymphohistiocytosis 9.83 9.57 13 215736 10614 63262659
Vascular device infection 9.81 9.57 50 215699 7262 63266011
Intestinal perforation 9.81 9.57 72 215677 11891 63261382
Blood creatine phosphokinase MB increased 9.79 9.57 16 215733 1200 63272073
Cardiomyopathy 9.79 9.57 29 215720 17555 63255718
Ocular hyperaemia 9.77 9.57 48 215701 25096 63248177
Paraesthesia 9.72 9.57 435 215314 156531 63116742
PO2 abnormal 9.70 9.57 3 215746 10 63273263
Herpes zoster 9.68 9.57 357 215392 82105 63191168
Enthesopathy 9.66 9.57 9 215740 8605 63264668
Renal disorder 9.60 9.57 69 215680 32905 63240368
Intentional dose omission 9.58 9.57 8 215741 8067 63265206

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 1660.28 10.46 2936 139093 197426 34617476
Drug abuse 1365.86 10.46 1840 140189 97256 34717646
Drug hypersensitivity 1207.57 10.46 1559 140470 78970 34735932
Respiratory depression 708.56 10.46 562 141467 15683 34799219
Overdose 644.56 10.46 1250 140779 89809 34725093
Drug dependence 507.75 10.46 557 141472 23660 34791242
Accidental overdose 406.23 10.46 454 141575 19686 34795216
Miosis 359.21 10.46 303 141726 9232 34805670
Substance abuse 292.33 10.46 245 141784 7396 34807506
Somnolence 277.21 10.46 1036 140993 110080 34704822
Poisoning 259.28 10.46 283 141746 11943 34802959
Death 259.00 10.46 2608 139421 395441 34419461
Respiratory arrest 248.76 10.46 425 141604 27618 34787284
Hyperaesthesia 231.97 10.46 174 141855 4456 34810446
Depressed level of consciousness 213.79 10.46 511 141518 42330 34772572
Drug withdrawal syndrome 213.22 10.46 328 141701 19506 34795396
Off label use 211.99 10.46 932 141097 418592 34396310
Sedation 193.77 10.46 324 141705 20682 34794220
Asphyxia 191.79 10.46 184 141845 6651 34808251
Unresponsive to stimuli 189.17 10.46 374 141655 27195 34787707
Coma 178.51 10.46 497 141532 45181 34769721
Delirium 171.26 10.46 478 141551 43513 34771389
Confusional state 160.70 10.46 1069 140960 143091 34671811
Bradypnoea 147.72 10.46 109 141920 2720 34812182
Pulmonary oedema 145.92 10.46 475 141554 47054 34767848
Mental status changes 140.61 10.46 406 141623 37677 34777225
Accidental death 138.18 10.46 99 141930 2357 34812545
Cardio-respiratory arrest 133.17 10.46 510 141519 54763 34760139
Inadequate analgesia 131.95 10.46 104 141925 2871 34812031
Intentional product misuse 129.50 10.46 444 141585 45167 34769735
Drug screen positive 123.80 10.46 113 141916 3830 34811072
Malignant neoplasm progression 122.05 10.46 691 141338 87355 34727547
Acute chest syndrome 119.21 10.46 61 141968 766 34814136
Constipation 118.85 10.46 957 141072 136025 34678877
Completed suicide 113.54 10.46 735 141294 97433 34717469
Cardiac arrest 111.85 10.46 721 141308 95438 34719464
Lethargy 111.27 10.46 394 141635 40728 34774174
Product dose omission issue 101.97 10.46 208 141821 119503 34695399
Respiratory rate decreased 101.48 10.46 81 141948 2278 34812624
Withdrawal syndrome 99.07 10.46 180 141849 12275 34802627
Agitation 94.19 10.46 472 141557 56927 34757975
Brain oedema 90.59 10.46 184 141845 13637 34801265
Drug abuser 88.15 10.46 94 141935 3860 34811042
Apnoea 85.77 10.46 120 141909 6544 34808358
Drug ineffective 85.06 10.46 1326 140703 455425 34359477
Vomiting 81.67 10.46 1436 140593 246185 34568717
Sedation complication 76.41 10.46 61 141968 1716 34813186
Myoclonus 69.51 10.46 172 141857 14553 34800349
Product use in unapproved indication 67.16 10.46 248 141781 117251 34697651
Myocardial infarction 66.99 10.46 259 141770 120826 34694076
Nausea 66.30 10.46 1828 140201 338080 34476822
Pulmonary congestion 66.26 10.46 162 141867 13603 34801299
COVID-19 64.09 10.46 137 141892 77413 34737489
Cardiac failure congestive 60.90 10.46 157 141872 83113 34731789
Drug use disorder 60.82 10.46 80 141949 4111 34810791
Oxygen saturation decreased 59.75 10.46 399 141630 53419 34761483
Hypoventilation 58.82 10.46 71 141958 3343 34811559
Cytomegalovirus infection 56.27 10.46 18 142011 26117 34788785
Pneumonia aspiration 56.11 10.46 326 141703 41577 34773325
Myalgia 55.99 10.46 166 141863 83944 34730958
Plasma cell myeloma 54.97 10.46 325 141704 41712 34773190
Pain 54.43 10.46 1149 140880 203526 34611376
Sphincter of Oddi dysfunction 52.33 10.46 20 142009 116 34814786
Cough 52.26 10.46 376 141653 149764 34665138
Hyperhidrosis 51.65 10.46 502 141527 75190 34739712
Treatment failure 50.99 10.46 69 141960 46628 34768274
Drug resistance 48.91 10.46 22 142007 25905 34788997
Serotonin syndrome 48.02 10.46 184 141845 19749 34795153
Sickle cell anaemia with crisis 47.78 10.46 70 141959 3983 34810919
Hallucination 46.31 10.46 363 141666 51135 34763767
Drug diversion 46.19 10.46 34 141995 845 34814057
Hypoxia 46.10 10.46 382 141647 54713 34760189
Exposure to toxic agent 45.55 10.46 65 141964 3610 34811292
Respiratory acidosis 45.36 10.46 77 141952 4973 34809929
Renal impairment 44.40 10.46 215 141814 94298 34720604
Exposure via ingestion 43.66 10.46 49 141980 2132 34812770
Hypoxic-ischaemic encephalopathy 41.90 10.46 70 141959 4462 34810440
Cerebrovascular accident 40.97 10.46 191 141838 84620 34730282
Condition aggravated 40.44 10.46 544 141485 191652 34623250
Hospitalisation 40.29 10.46 109 141920 56793 34758109
Melaena 39.93 10.46 51 141978 35329 34779573
Respiratory distress 39.92 10.46 265 141764 35400 34779502
Hypogonadism male 39.68 10.46 22 142007 328 34814574
Syncope 39.03 10.46 215 141814 91236 34723666
PCO2 increased 38.94 10.46 27 142002 609 34814293
Coronary artery disease 38.53 10.46 87 141942 48218 34766684
Dizziness 37.59 10.46 643 141386 217878 34597024
Opiates positive 36.36 10.46 25 142004 556 34814346
Tubulointerstitial nephritis 34.97 10.46 21 142008 21003 34793899
Amnestic disorder 34.69 10.46 18 142011 233 34814669
Cancer pain 34.21 10.46 48 141981 2624 34812278
Haematochezia 33.80 10.46 88 141941 46446 34768456
Diarrhoea 33.36 10.46 1272 140757 388640 34426262
Clumsiness 33.12 10.46 38 141991 1694 34813208
Accident 32.84 10.46 67 141962 4980 34809922
Arthralgia 32.68 10.46 490 141539 169551 34645351
Product used for unknown indication 32.49 10.46 29 142000 954 34813948
Basal cell carcinoma 32.19 10.46 20 142009 19638 34795264
Cardiac failure 31.97 10.46 228 141801 91020 34723882
Blood glucose increased 31.77 10.46 151 141878 66567 34748335
Atrial fibrillation 31.65 10.46 331 141698 122062 34692840
Urinary retention 31.64 10.46 254 141775 36034 34778868
Blood pH decreased 31.49 10.46 43 141986 2291 34812611
Stupor 31.32 10.46 48 141981 2843 34812059
Poisoning deliberate 31.25 10.46 86 141943 7758 34807144
Diaphragmatic spasm 30.60 10.46 13 142016 103 34814799
Aspiration 30.56 10.46 114 141915 12080 34802822
Drug eruption 30.22 10.46 22 142007 19876 34795026
Accidental poisoning 29.53 10.46 25 142004 765 34814137
Diabetes mellitus inadequate control 29.47 10.46 9 142020 13455 34801447
Self-medication 29.45 10.46 45 141984 2658 34812244
Metastases to bone 29.25 10.46 111 141918 11859 34803043
Faecal volume decreased 29.17 10.46 13 142016 117 34814785
Dyspnoea 28.40 10.46 1247 140782 375535 34439367
Haematuria 28.36 10.46 106 141923 49960 34764942
Toxicologic test abnormal 28.08 10.46 21 142008 535 34814367
Sinusitis 28.05 10.46 81 141948 41321 34773581
Hypertension 28.02 10.46 388 141641 136055 34678847
Postoperative ileus 27.69 10.46 23 142006 685 34814217
Breakthrough pain 27.32 10.46 21 142008 558 34814344
Visual acuity reduced 27.04 10.46 16 142013 16133 34798769
Foetal exposure during pregnancy 26.95 10.46 73 141956 38028 34776874
Allodynia 26.45 10.46 24 142005 807 34814095
Hypotension 26.30 10.46 1126 140903 220523 34594379
Pathogen resistance 25.47 10.46 4 142025 9478 34805424
Full blood count abnormal 25.41 10.46 23 142006 18645 34796257
Anaemia 25.11 10.46 739 141290 232596 34582306
Injection site swelling 24.70 10.46 8 142021 11519 34803383
Weight increased 24.70 10.46 250 141779 92783 34722119
Neuroleptic malignant syndrome 24.53 10.46 22 142007 17912 34796990
Hepatic function abnormal 24.43 10.46 95 141934 44268 34770634
Interstitial lung disease 24.41 10.46 160 141869 65122 34749780
Neoplasm progression 24.21 10.46 170 141859 23130 34791772
Chronic kidney disease 24.16 10.46 86 141943 41124 34773778
Glycosylated haemoglobin increased 24.14 10.46 8 142021 11352 34803550
Herpes simplex viraemia 24.00 10.46 10 142019 75 34814827
Spinal cord compression 23.80 10.46 51 141978 3924 34810978
Drug-induced liver injury 23.75 10.46 51 141978 28781 34786121
Fatigue 23.71 10.46 1248 140781 369405 34445497
Hypercapnia 23.67 10.46 53 141976 4202 34810700
Myelosuppression 23.63 10.46 26 142003 19239 34795663
Gout 23.60 10.46 26 142003 19227 34795675
Drug tolerance 23.36 10.46 42 141987 2840 34812062
Failure to suspend medication 23.15 10.46 17 142012 421 34814481
Therapeutic product effect incomplete 23.13 10.46 116 141913 50425 34764477
Pulmonary haemorrhage 23.10 10.46 93 141936 10211 34804691
Dyspnoea exertional 22.99 10.46 94 141935 43185 34771717
Headache 22.70 10.46 631 141398 200004 34614898
Disorientation 22.56 10.46 220 141809 32968 34781934
Back pain 22.21 10.46 650 141379 121139 34693763
Sinus tachycardia 21.90 10.46 133 141896 17227 34797675
Lung cancer metastatic 21.81 10.46 40 141989 2747 34812155
Transient ischaemic attack 21.80 10.46 50 141979 27563 34787339
Intestinal obstruction 21.69 10.46 163 141866 22659 34792243
Delusion of grandeur 21.43 10.46 25 142004 1135 34813767
Diabetes mellitus 21.21 10.46 108 141921 46765 34768137
Therapy interrupted 20.99 10.46 15 142014 13682 34801220
Loss of personal independence in daily activities 20.98 10.46 67 141962 33112 34781790
Nerve injury 20.93 10.46 45 141984 3470 34811432
Reaction to excipient 20.71 10.46 17 142012 498 34814404
Transplant rejection 20.65 10.46 8 142021 10303 34804599
Progressive multifocal leukoencephalopathy 20.53 10.46 7 142022 9757 34805145
Orthostatic hypotension 20.40 10.46 47 141982 25872 34789030
Muscle swelling 20.30 10.46 15 142014 375 34814527
Drug intolerance 20.30 10.46 150 141879 59420 34755482
Angina unstable 20.30 10.46 11 142018 11642 34803260
Rash 20.25 10.46 721 141308 222031 34592871
Psoriasis 20.18 10.46 85 141944 38727 34776175
Medication error 20.18 10.46 175 141854 25390 34789512
Mydriasis 20.13 10.46 70 141959 7167 34807735
Abdominal compartment syndrome 20.09 10.46 22 142007 931 34813971
White blood cell count decreased 20.09 10.46 270 141759 95175 34719727
Blood cholesterol increased 19.85 10.46 33 141996 20510 34794392
Neurological examination abnormal 19.81 10.46 13 142016 267 34814635
Non-small cell lung cancer 19.63 10.46 47 141982 3893 34811009
Post procedural complication 19.62 10.46 95 141934 11293 34803609
Body temperature increased 19.40 10.46 129 141900 17239 34797663
Bladder dilatation 19.40 10.46 27 142002 1465 34813437
Tumour pain 19.20 10.46 23 142006 1074 34813828
Weaning failure 19.05 10.46 12 142017 229 34814673
Neutropenia 19.05 10.46 488 141541 156290 34658612
Secondary hypogonadism 18.91 10.46 13 142016 289 34814613
Gastrointestinal motility disorder 18.86 10.46 36 141993 2548 34812354
Hepatic enzyme increased 18.86 10.46 88 141941 38992 34775910
Glomerular filtration rate decreased 18.83 10.46 15 142014 12946 34801956
Drug level 18.63 10.46 5 142024 6 34814896
Encephalopathy 18.39 10.46 222 141807 35097 34779805
Rhinalgia 18.30 10.46 22 142007 1031 34813871
Neuroblastoma 18.27 10.46 11 142018 193 34814709
Pupil fixed 18.25 10.46 29 142000 1772 34813130
Disease recurrence 17.71 10.46 38 141991 21452 34793450
Patient uncooperative 17.69 10.46 15 142014 460 34814442
Brain injury 17.60 10.46 60 141969 6082 34808820
Acute myocardial infarction 17.48 10.46 137 141892 53582 34761320
Tooth injury 17.48 10.46 23 142006 1182 34813720
Bronchiectasis 17.44 10.46 9 142020 9792 34805110
Peripheral swelling 17.41 10.46 213 141816 76328 34738574
Myopathy 17.26 10.46 13 142016 11541 34803361
C-reactive protein abnormal 17.05 10.46 7 142022 8703 34806199
Apnoeic attack 17.00 10.46 14 142015 412 34814490
Chemical poisoning 16.98 10.46 9 142020 122 34814780
Cerebral infarction 16.97 10.46 56 141973 27399 34787503
Incoherent 16.94 10.46 48 141981 4404 34810498
Intensive care 16.91 10.46 16 142013 568 34814334
Cyanosis 16.88 10.46 99 141930 12665 34802237
Salivary hypersecretion 16.83 10.46 7 142022 8637 34806265
Post stroke epilepsy 16.78 10.46 5 142024 11 34814891
Visual impairment 16.47 10.46 82 141947 35720 34779182
Substance use disorder 16.45 10.46 18 142011 761 34814141
Post laminectomy syndrome 16.44 10.46 10 142019 179 34814723
Polyneuropathy in malignant disease 16.42 10.46 11 142018 234 34814668
Acute pulmonary oedema 16.24 10.46 66 141963 7277 34807625
Pelvic pain 16.23 10.46 33 141996 2447 34812455
C-reactive protein increased 16.22 10.46 141 141888 53957 34760945
Biliary obstruction 16.18 10.46 35 141994 2710 34812192
No adverse event 16.16 10.46 44 141985 22883 34792019
Substance dependence 16.15 10.46 13 142016 370 34814532
Cerebrospinal fluid leakage 16.13 10.46 15 142014 521 34814381
Ischaemic stroke 16.12 10.46 31 141998 18219 34796683
Psychotic behaviour 16.06 10.46 17 142012 692 34814210
Carcinoid crisis 16.02 10.46 11 142018 244 34814658
Device failure 16.00 10.46 32 141997 2344 34812558
Visceral congestion 15.88 10.46 16 142013 614 34814288
Vestibular disorder 15.86 10.46 21 142008 1086 34813816
Thrombotic microangiopathy 15.83 10.46 12 142017 10618 34804284
Lactic acidosis 15.80 10.46 80 141949 34692 34780210
Aggression 15.77 10.46 234 141795 38730 34776172
Respiratory failure 15.77 10.46 564 141465 108008 34706894
Intentional product use issue 15.76 10.46 161 141868 59655 34755247
Photosensitivity reaction 15.72 10.46 12 142017 10582 34804320
Ejection fraction decreased 15.68 10.46 34 141995 19120 34795782
Hypercholesterolaemia 15.66 10.46 8 142021 8754 34806148
Immune reconstitution inflammatory syndrome 15.65 10.46 8 142021 8751 34806151
SARS-CoV-2 test negative 15.63 10.46 20 142009 1000 34813902
Drug reaction with eosinophilia and systemic symptoms 15.54 10.46 75 141954 32937 34781965
Hypogammaglobulinaemia 15.51 10.46 6 142023 7734 34807168
Angina pectoris 15.51 10.46 70 141959 31293 34783609
Toxic leukoencephalopathy 15.49 10.46 13 142016 393 34814509
Cluster headache 15.43 10.46 15 142014 551 34814351
Squamous cell carcinoma of skin 15.30 10.46 13 142016 10868 34804034
Accidental exposure to product by child 15.28 10.46 24 142005 1452 34813450
Hypoglycaemia 15.26 10.46 145 141884 54495 34760407
Dependence 15.23 10.46 21 142008 1129 34813773
Decerebration 15.21 10.46 5 142024 17 34814885
Eosinophilia 15.18 10.46 55 141974 26167 34788735
Epstein-Barr virus infection 15.14 10.46 6 142023 7622 34807280
Synovitis 15.13 10.46 21 142008 14045 34800857
Hepatitis B 15.03 10.46 3 142026 5980 34808922
Parathyroid hormone-related protein abnormal 14.99 10.46 5 142024 18 34814884
Bladder cancer 14.95 10.46 27 142002 16251 34798651
Infusion site granuloma 14.82 10.46 4 142025 5 34814897
Pupillary reflex impaired 14.77 10.46 24 142005 1495 34813407
Diabetic ketoacidosis 14.76 10.46 32 141997 18000 34796902
Multiple sclerosis relapse 14.74 10.46 19 142010 13114 34801788
Accidental underdose 14.73 10.46 14 142015 500 34814402
Procedural vomiting 14.68 10.46 10 142019 219 34814683
Anal inflammation 14.67 10.46 22 142007 1278 34813624
Acute respiratory failure 14.65 10.46 191 141838 30737 34784165
Bone marrow failure 14.64 10.46 65 141964 29188 34785714
End stage renal disease 14.53 10.46 9 142020 8852 34806050
Proteinuria 14.52 10.46 34 141995 18608 34796294
Oesophageal carcinoma 14.51 10.46 10 142019 9294 34805608
Fall 14.50 10.46 675 141354 202210 34612692
Monocytopenia 14.41 10.46 7 142022 78 34814824
Postmortem blood drug level abnormal 14.39 10.46 11 142018 290 34814612
Blood triglycerides increased 14.39 10.46 22 142007 14137 34800765
Liver disorder 14.38 10.46 77 141952 32920 34781982
Carcinoid tumour 14.33 10.46 10 142019 228 34814674
Victim of homicide 14.27 10.46 8 142021 122 34814780
Thirst decreased 14.21 10.46 5 142024 22 34814880
Hypertensive crisis 14.19 10.46 9 142020 8742 34806160
Nephrotic syndrome 14.08 10.46 6 142023 7297 34807605
Wrong technique in product usage process 14.06 10.46 87 141942 35899 34779003
Eczema 14.06 10.46 34 141995 18402 34796500
Scan gallium abnormal 14.03 10.46 5 142024 23 34814879
Acidosis 13.90 10.46 84 141945 10861 34804041
Haematotoxicity 13.89 10.46 8 142021 8186 34806716
Disease prodromal stage 13.86 10.46 5 142024 24 34814878
Liver function test 13.76 10.46 6 142023 51 34814851
Vision blurred 13.69 10.46 120 141909 45843 34769059
Medical device site bruise 13.68 10.46 4 142025 8 34814894
Tuberculosis 13.67 10.46 9 142020 8568 34806334
Product storage error 13.67 10.46 8 142021 8114 34806788
Medical device site haemorrhage 13.56 10.46 8 142021 135 34814767
Arrhythmia neonatal 13.53 10.46 3 142026 0 34814902
Opiates 13.53 10.46 3 142026 0 34814902
Small intestinal obstruction 13.47 10.46 105 141924 14761 34800141
Head injury 13.45 10.46 34 141995 18126 34796776
Anorgasmia 13.44 10.46 17 142012 840 34814062
Prescribed underdose 13.41 10.46 10 142019 8923 34805979
Ileus paralytic 13.34 10.46 54 141975 5943 34808959
Hyponatraemia 13.32 10.46 246 141783 82445 34732457
Pulmonary fibrosis 13.19 10.46 35 141994 18361 34796541
Therapy cessation 13.18 10.46 31 141998 16942 34797960
Lymphocyte count abnormal 13.13 10.46 20 142009 1178 34813724
Electrocardiogram low voltage 13.08 10.46 5 142024 29 34814873
Injection site pruritus 13.05 10.46 6 142023 6977 34807925
Oesophagitis chemical 13.00 10.46 6 142023 59 34814843
Megacolon 12.95 10.46 25 142004 1785 34813117
Cardiac failure chronic 12.92 10.46 8 142021 7871 34807031
Injection site pain 12.91 10.46 99 141930 38906 34775996
Blood chromogranin A increased 12.84 10.46 10 142019 271 34814631
Red blood cell sedimentation rate increased 12.82 10.46 11 142018 9151 34805751
Cholestatic liver injury 12.65 10.46 29 142000 2335 34812567
Nasopharyngitis 12.61 10.46 204 141825 69764 34745138
Foetal exposure during delivery 12.59 10.46 7 142022 105 34814797
Blood pH increased 12.58 10.46 15 142014 697 34814205
Palpitations 12.54 10.46 103 141926 39883 34775019
Erythema 12.53 10.46 270 141759 88510 34726392
Impaired quality of life 12.53 10.46 4 142025 5814 34809088
Subarachnoid haemorrhage 12.49 10.46 20 142009 12615 34802287
Cheyne-Stokes respiration 12.47 10.46 10 142019 283 34814619
Neutrophil count decreased 12.47 10.46 140 141889 50964 34763938
Hypogonadism 12.44 10.46 28 142001 2227 34812675
Foaming at mouth 12.38 10.46 16 142013 808 34814094
Nephropathy toxic 12.37 10.46 20 142009 12568 34802334
Proctalgia 12.31 10.46 51 141978 5672 34809230
Arachnoiditis 12.29 10.46 11 142018 363 34814539
Perineal pain 12.24 10.46 16 142013 817 34814085
Eosinophilic myocarditis 12.09 10.46 13 142016 539 34814363
Intentional misuse of drug delivery system 12.08 10.46 4 142025 14 34814888
Respiratory paralysis 12.04 10.46 6 142023 71 34814831
Vasculitis 12.02 10.46 17 142012 11279 34803623
Syringe issue 12.02 10.46 4 142025 5660 34809242
Bronchopulmonary aspergillosis 12.01 10.46 26 142003 14633 34800269
Herpes zoster 12.01 10.46 86 141943 34313 34780589
Hypersensitivity 12.00 10.46 175 141854 60860 34754042
Asthma 11.99 10.46 113 141916 42543 34772359
Anamnestic reaction 11.95 10.46 5 142024 38 34814864
Gastrointestinal hypomotility 11.88 10.46 18 142011 1055 34813847
Venoocclusive liver disease 11.85 10.46 9 142020 7957 34806945
Product residue present 11.84 10.46 31 141998 2715 34812187
Metastatic renal cell carcinoma 11.83 10.46 26 142003 2035 34812867
Neuropathy peripheral 11.82 10.46 253 141776 83010 34731892
Urinary tract infection 11.78 10.46 256 141773 83825 34731077
Antasthmatic drug level 11.73 10.46 5 142024 40 34814862
Cachexia 11.71 10.46 59 141970 7127 34807775
Necrotising colitis 11.70 10.46 18 142011 1070 34813832
Obsessive-compulsive disorder 11.68 10.46 4 142025 5560 34809342
Disease progression 11.67 10.46 544 141485 107533 34707369
Haemorrhagic stroke 11.64 10.46 6 142023 6533 34808369
Appendicitis 11.53 10.46 27 142002 14780 34800122
Muscle spasticity 11.53 10.46 51 141978 5837 34809065
Metastases to lung 11.50 10.46 71 141958 9249 34805653
Restlessness 11.50 10.46 156 141873 25326 34789576
Disability 11.49 10.46 44 141985 4721 34810181
Cardiac murmur 11.47 10.46 9 142020 7828 34807074
Infantile fibromatosis 11.46 10.46 3 142026 3 34814899
Atrial septal defect 11.45 10.46 8 142021 7384 34807518
Analgesic drug level 11.42 10.46 5 142024 43 34814859
Pemphigoid 11.41 10.46 11 142018 8655 34806247
Device computer issue 11.29 10.46 4 142025 18 34814884
Device toxicity 11.29 10.46 4 142025 18 34814884
Chest discomfort 11.20 10.46 155 141874 54375 34760527
Abdominal pain upper 11.11 10.46 214 141815 71276 34743626
Alcohol poisoning 11.09 10.46 36 141993 3557 34811345
Hypopnoea 11.08 10.46 27 142002 2262 34812640
Blood pressure diastolic decreased 11.05 10.46 69 141960 9025 34805877
Paraparesis 11.04 10.46 24 142005 1865 34813037
Narcotic bowel syndrome 11.00 10.46 7 142022 136 34814766
Atrioventricular block complete 10.97 10.46 13 142016 9306 34805596
Extramedullary haemopoiesis 10.91 10.46 6 142023 88 34814814
Respiration abnormal 10.89 10.46 33 141996 3143 34811759
Product prescribing error 10.84 10.46 52 141977 22875 34792027
Cor pulmonale acute 10.81 10.46 9 142020 269 34814633
Conjunctival discolouration 10.80 10.46 4 142025 21 34814881
Leukopenia 10.76 10.46 185 141844 62671 34752231
Prostate cancer 10.74 10.46 106 141923 39543 34775359
Electroencephalogram abnormal 10.71 10.46 28 142001 2450 34812452
Eye irritation 10.67 10.46 9 142020 7552 34807350
Haemophagocytic lymphohistiocytosis 10.64 10.46 23 142006 12950 34801952
Large intestine perforation 10.63 10.46 65 141964 8438 34806464
Lower respiratory tract infection viral 10.62 10.46 10 142019 353 34814549
Rash pruritic 10.59 10.46 65 141964 26876 34788026
Contraindicated product administered 10.58 10.46 48 141981 21433 34793469
Ileus 10.55 10.46 108 141921 16391 34798511
Sleep disorder due to a general medical condition 10.54 10.46 4 142025 5217 34809685
Jaundice 10.51 10.46 81 141948 31801 34783101
Alanine aminotransferase abnormal 10.50 10.46 3 142026 4685 34810217
Kidney transplant rejection 10.49 10.46 9 142020 7488 34807414
Vital functions abnormal 10.48 10.46 9 142020 281 34814621
Large intestine polyp 10.48 10.46 10 142019 7904 34806998
Acute graft versus host disease in skin 10.48 10.46 4 142025 5197 34809705
Balance disorder 10.47 10.46 110 141919 40544 34774358

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 5782.30 9.69 6342 294604 292574 79150868
Drug abuse 2392.28 9.69 3006 297940 159685 79283757
Toxicity to various agents 2339.67 9.69 5003 295943 416537 79026905
Respiratory depression 1032.40 9.69 847 300099 26783 79416659
Overdose 918.97 9.69 2099 298847 182107 79261335
Accidental overdose 701.02 9.69 805 300141 38776 79404666
Sedation 667.71 9.69 899 300047 50996 79392446
Death 651.44 9.69 4003 296943 562511 78880931
Depressed level of consciousness 649.49 9.69 1245 299701 95407 79348035
Miosis 621.38 9.69 499 300447 15290 79428152
Respiratory arrest 611.73 9.69 910 300036 56640 79386802
Constipation 483.28 9.69 2232 298714 280818 79162624
Somnolence 467.47 9.69 1963 298983 237018 79206424
Sedation complication 437.45 9.69 407 300539 15262 79428180
Drug dependence 429.39 9.69 642 300304 40127 79403315
Coma 365.13 9.69 1017 299929 99632 79343810
Substance abuse 360.63 9.69 307 300639 10219 79433223
Hyperaesthesia 346.08 9.69 320 300626 11902 79431540
Poisoning 343.73 9.69 450 300496 24822 79418620
Cardio-respiratory arrest 338.54 9.69 1039 299907 107471 79335971
Bradypnoea 335.72 9.69 235 300711 5817 79437625
Cardiac arrest 331.90 9.69 1408 299538 170688 79272754
Completed suicide 311.68 9.69 1784 299162 243983 79199459
Drug withdrawal syndrome 306.25 9.69 504 300442 34214 79409228
Creatinine renal clearance decreased 302.43 9.69 366 300580 18636 79424806
Unresponsive to stimuli 301.55 9.69 657 300289 55131 79388311
Off label use 254.13 9.69 2198 298748 905017 78538425
Asphyxia 250.17 9.69 263 300683 11457 79431985
Respiratory rate decreased 246.14 9.69 184 300762 5059 79438383
Blood calcium decreased 237.48 9.69 429 300517 31390 79412052
Intentional product misuse 218.13 9.69 822 300124 94343 79349099
Delirium 207.41 9.69 747 300199 83880 79359562
Mental status changes 202.13 9.69 634 300312 66325 79377117
Drug screen positive 197.87 9.69 172 300774 5891 79437551
Vomiting 191.67 9.69 3551 297395 662277 78781165
Acute chest syndrome 186.25 9.69 99 300847 1462 79441980
Malignant neoplasm progression 182.69 9.69 1003 299943 134987 79308455
Product dose omission issue 178.06 9.69 421 300525 247116 79196326
Accidental death 165.39 9.69 134 300812 4157 79439285
Confusional state 162.95 9.69 1876 299070 316121 79127321
Myoclonus 160.10 9.69 335 300611 27325 79416117
Drug abuser 152.25 9.69 148 300798 5865 79437577
Pulmonary oedema 151.73 9.69 698 300248 87556 79355886
COVID-19 144.74 9.69 232 300714 157442 79286000
Inadequate analgesia 142.42 9.69 127 300819 4502 79438940
Hypotension 142.34 9.69 2393 298553 437924 79005518
Lethargy 139.05 9.69 642 300304 80650 79362792
Exposure via ingestion 136.00 9.69 130 300816 5044 79438398
Alopecia 133.97 9.69 437 300509 230918 79212524
Drug ineffective 132.67 9.69 3090 297856 1077823 78365619
Systemic lupus erythematosus 128.31 9.69 161 300785 120988 79322454
Apnoea 127.06 9.69 187 300759 11517 79431925
Contrast media allergy 126.24 9.69 92 300854 2430 79441012
Arthralgia 125.95 9.69 1466 299480 570337 78873105
Maternal exposure during delivery 121.35 9.69 71 300875 1275 79442167
Arthropathy 121.21 9.69 309 300637 176802 79266640
Abdominal discomfort 118.25 9.69 515 300431 250212 79193230
Cognitive disorder 114.28 9.69 545 300401 69381 79374061
Orthostatic hypotension 113.18 9.69 466 300480 55698 79387744
Weight increased 110.44 9.69 605 300341 276781 79166661
Hypoxia 110.09 9.69 717 300229 102526 79340916
Agitation 109.71 9.69 698 300248 99017 79344425
Brain oedema 109.60 9.69 273 300673 24990 79418452
Drug diversion 105.01 9.69 63 300883 1187 79442255
Cardiac failure congestive 103.28 9.69 241 300705 142161 79301281
Poisoning deliberate 99.73 9.69 220 300726 18608 79424834
Hallucination 97.93 9.69 606 300340 85139 79358303
Sinusitis 95.58 9.69 396 300550 195105 79248337
Folliculitis 94.94 9.69 45 300901 55335 79388107
Withdrawal syndrome 94.01 9.69 268 300678 26586 79416856
Pemphigus 92.81 9.69 145 300801 99437 79344005
Glossodynia 91.14 9.69 156 300790 103181 79340261
Condition aggravated 91.06 9.69 1337 299609 499787 78943655
Balance disorder 90.86 9.69 662 300284 98195 79345247
Sleep disorder due to general medical condition, insomnia type 86.85 9.69 28 300918 43528 79399914
Helicobacter infection 86.70 9.69 81 300865 69623 79373819
Sphincter of Oddi dysfunction 86.36 9.69 39 300907 394 79443048
Muscle injury 85.51 9.69 38 300908 48523 79394919
Fatigue 84.31 9.69 2772 298174 926955 78516487
Nausea 84.30 9.69 4415 296531 952781 78490661
Device expulsion 84.17 9.69 3 300943 25858 79417584
Respiratory acidosis 82.28 9.69 150 300796 11050 79432392
Urinary retention 81.64 9.69 426 300520 56204 79387238
Irritable bowel syndrome 81.41 9.69 69 300877 62172 79381270
Oxygen saturation decreased 78.36 9.69 788 300158 128259 79315183
Hand deformity 76.85 9.69 174 300772 103745 79339697
Hypercapnia 76.48 9.69 128 300818 8807 79434635
Myocardial infarction 76.35 9.69 396 300550 183733 79259709
Swelling 75.48 9.69 493 300453 216218 79227224
Aspiration 74.32 9.69 205 300741 19953 79423489
Pericarditis 74.30 9.69 178 300768 104058 79339384
Duodenal ulcer perforation 73.26 9.69 85 300861 66126 79377316
Anterior spinal artery syndrome 71.60 9.69 25 300921 117 79443325
Toxicologic test abnormal 71.24 9.69 51 300895 1309 79442133
Peripheral swelling 71.16 9.69 662 300284 268955 79174487
Cough 69.94 9.69 969 299977 365820 79077622
Injection site erythema 69.92 9.69 117 300829 78080 79365362
Hypoventilation 69.33 9.69 109 300837 7115 79436327
Gastrointestinal disorder 68.51 9.69 234 300712 121971 79321471
Acidosis 67.99 9.69 196 300750 19566 79423876
Nasopharyngitis 67.58 9.69 622 300324 253259 79190183
Pulmonary congestion 67.02 9.69 240 300706 26860 79416582
Anti-cyclic citrullinated peptide antibody positive 64.97 9.69 135 300811 83008 79360434
Myalgia 64.29 9.69 423 300523 185218 79258224
Injection site swelling 63.19 9.69 51 300895 47081 79396361
Dizziness 63.07 9.69 1509 299437 524932 78918510
Plasma cell myeloma 63.07 9.69 380 300566 52879 79390563
Cytomegalovirus infection 62.54 9.69 42 300904 42602 79400840
Retinitis 61.02 9.69 90 300856 5553 79437889
Injection site pruritus 60.21 9.69 43 300903 42240 79401202
Intestinal pseudo-obstruction 60.10 9.69 61 300885 2548 79440894
Syncope 60.09 9.69 413 300533 179036 79264406
Mobility decreased 59.87 9.69 715 300231 121460 79321982
Contusion 58.87 9.69 325 300621 148451 79294991
Red blood cell sedimentation rate abnormal 57.65 9.69 6 300940 20957 79422485
Respiratory failure 57.10 9.69 980 299966 179931 79263511
Ill-defined disorder 56.67 9.69 101 300845 65774 79377668
Opiates positive 55.72 9.69 39 300907 965 79442477
Narcotic bowel syndrome 55.15 9.69 25 300921 255 79443187
Visceral congestion 55.08 9.69 38 300908 918 79442524
Dilatation intrahepatic duct acquired 53.86 9.69 34 300912 704 79442738
Injection site reaction 52.74 9.69 78 300868 54707 79388735
Impaired healing 52.48 9.69 163 300783 87492 79355950
Diarrhoea 52.47 9.69 2753 298193 877736 78565706
Serotonin syndrome 51.88 9.69 319 300627 44708 79398734
Hyperhidrosis 51.61 9.69 831 300115 150661 79292781
Hypoxic-ischaemic encephalopathy 51.56 9.69 100 300846 7720 79435722
Full blood count abnormal 51.56 9.69 46 300900 40428 79403014
Drug use disorder 51.49 9.69 106 300840 8545 79434897
Intentional product use issue 51.46 9.69 349 300597 151763 79291679
Drug resistance 51.39 9.69 50 300896 42163 79401279
Hypersensitivity 51.31 9.69 689 300257 261550 79181892
Joint swelling 50.98 9.69 774 300172 287872 79155570
Hepatic enzyme increased 50.94 9.69 442 300504 182168 79261274
Accidental exposure to product by child 50.92 9.69 59 300887 2867 79440575
Coronary artery disease 50.57 9.69 107 300839 65367 79378075
Abortion spontaneous 50.54 9.69 24 300922 29483 79413959
Injection site pain 50.08 9.69 286 300660 129552 79313890
Respiratory distress 49.82 9.69 384 300562 57955 79385487
Post procedural complication 49.81 9.69 200 300746 23629 79419813
Dyspnoea exertional 49.29 9.69 166 300780 86907 79356535
Neutropenic sepsis 48.69 9.69 217 300729 26847 79416595
Hypogonadism male 47.49 9.69 20 300926 168 79443274
Hospitalisation 47.20 9.69 189 300757 94047 79349395
Allodynia 46.36 9.69 43 300903 1605 79441837
Dyspnoea 46.36 9.69 2705 298241 854320 78589122
Sickle cell anaemia with crisis 45.90 9.69 96 300850 7826 79435616
Blood pH decreased 45.10 9.69 71 300875 4640 79438802
Spinal cord compression 45.07 9.69 84 300862 6293 79437149
Tubulointerstitial nephritis 44.59 9.69 47 300899 38188 79405254
Transient ischaemic attack 44.24 9.69 82 300864 52613 79390829
Rash 44.15 9.69 1760 299186 576598 78866844
Nasal congestion 43.98 9.69 145 300801 76407 79367035
Cyanosis 43.87 9.69 200 300746 24982 79418460
Progressive multifocal leukoencephalopathy 43.33 9.69 12 300934 20588 79422854
Cerebrovascular accident 43.25 9.69 376 300570 154916 79288526
Interstitial lung disease 42.90 9.69 249 300697 112351 79331091
Wound 42.64 9.69 260 300686 115919 79327523
Headache 41.98 9.69 2028 298918 651744 78791698
Therapy interrupted 41.90 9.69 34 300912 31307 79412135
C-reactive protein abnormal 41.74 9.69 74 300872 48293 79395149
Pneumonia aspiration 41.63 9.69 411 300535 66556 79376886
Transplant rejection 41.49 9.69 11 300935 19426 79424016
Exostosis 41.43 9.69 149 300797 16709 79426733
Pregnancy 41.35 9.69 25 300921 26826 79416616
Blister 40.96 9.69 273 300673 119203 79324239
Cardiac failure 40.90 9.69 380 300566 154462 79288980
Contraindicated product administered 40.59 9.69 389 300557 157149 79286293
Impaired work ability 40.41 9.69 12 300934 19669 79423773
Eczema 40.39 9.69 57 300889 40761 79402681
Pupillary reflex impaired 39.95 9.69 56 300890 3297 79440145
Exposure to toxic agent 39.75 9.69 99 300847 9059 79434383
Encephalopathy 39.67 9.69 409 300537 66988 79376454
Cancer pain 39.49 9.69 71 300875 5174 79438268
Joint dislocation 39.35 9.69 147 300799 16792 79426650
Tenosynovitis 39.02 9.69 6 300940 15548 79427894
Product use in unapproved indication 38.38 9.69 689 300257 249670 79193772
Self-medication 38.04 9.69 69 300877 5063 79438379
Synovitis 37.24 9.69 376 300570 150358 79293084
Neutropenia 37.11 9.69 815 300131 286895 79156547
Sopor 36.92 9.69 42 300904 32968 79410474
Atrial fibrillation 36.52 9.69 526 300420 197360 79246082
Postoperative ileus 36.35 9.69 31 300915 1034 79442408
Multiple sclerosis relapse 35.97 9.69 76 300870 46457 79396985
Obliterative bronchiolitis 35.23 9.69 50 300896 2978 79440464
Wrong technique in product usage process 35.23 9.69 151 300795 73724 79369718
Melaena 35.21 9.69 115 300831 60775 79382667
Cholestasis 34.96 9.69 325 300621 51784 79391658
Therapeutic product effect decreased 34.82 9.69 423 300523 163440 79280002
Pupil fixed 34.49 9.69 54 300892 3512 79439930
Small intestinal obstruction 34.49 9.69 198 300748 27074 79416368
Hepatic function abnormal 33.91 9.69 151 300795 72956 79370486
Musculoskeletal stiffness 33.78 9.69 461 300485 174547 79268895
Soft tissue disorder 33.68 9.69 53 300893 3462 79439980
Patient uncooperative 33.39 9.69 25 300921 689 79442753
Lung cancer metastatic 33.01 9.69 54 300892 3645 79439797
Intestinal obstruction 32.83 9.69 276 300670 42744 79400698
Disorientation 32.79 9.69 372 300574 62404 79381038
Incoherent 32.19 9.69 82 300864 7610 79435832
Renal impairment 32.14 9.69 411 300535 157372 79286070
Loss of personal independence in daily activities 31.94 9.69 241 300705 102339 79341103
Myopathy 31.87 9.69 19 300927 20544 79422898
PCO2 increased 31.85 9.69 37 300909 1803 79441639
Aggression 31.31 9.69 312 300634 50646 79392796
Skin candida 31.27 9.69 39 300907 2048 79441394
Therapy cessation 31.05 9.69 59 300887 37503 79405939
Impaired quality of life 30.98 9.69 8 300938 14378 79429064
Diaphragmatic spasm 30.79 9.69 13 300933 110 79443332
Procedural pain 30.78 9.69 170 300776 22914 79420528
Chronic kidney disease 30.46 9.69 137 300809 66017 79377425
Tendonitis 30.45 9.69 27 300919 23803 79419639
Toxic leukoencephalopathy 30.34 9.69 29 300917 1125 79442317
Neoplasm progression 30.11 9.69 313 300633 51369 79392073
Product used for unknown indication 30.05 9.69 33 300913 1511 79441931
Drug withdrawal syndrome neonatal 30.03 9.69 17 300929 286 79443156
Mydriasis 29.90 9.69 139 300807 17504 79425938
Sinus tachycardia 29.89 9.69 240 300706 36668 79406774
Haematochezia 29.67 9.69 201 300745 87444 79355998
Granulocytopenia 29.63 9.69 4 300942 11427 79432015
Carcinoid tumour 29.44 9.69 21 300925 536 79442906
Metastases to bone 29.37 9.69 175 300771 24252 79419190
Disease recurrence 29.35 9.69 78 300868 44031 79399411
Stomatitis 29.26 9.69 384 300562 146373 79297069
Immune reconstitution inflammatory syndrome 29.23 9.69 8 300938 13833 79429609
Ventilation perfusion mismatch 29.02 9.69 22 300924 618 79442824
Weaning failure 28.99 9.69 23 300923 692 79442750
Non-small cell lung cancer 28.93 9.69 70 300876 6290 79437152
Drug tolerance 28.84 9.69 85 300861 8590 79434852
Pancreatic fibrosis 28.58 9.69 12 300934 100 79443342
Treatment failure 28.44 9.69 462 300484 170024 79273418
Ischaemic stroke 28.31 9.69 51 300895 33080 79410362
Hypertension 28.14 9.69 994 299952 329998 79113444
Breakthrough pain 28.12 9.69 30 300916 1329 79442113
Accident 27.92 9.69 85 300861 8746 79434696
Eye pain 27.71 9.69 63 300883 37515 79405927
Injection site rash 27.26 9.69 17 300929 17937 79425505
Pathogen resistance 27.24 9.69 10 300936 14332 79429110
Discomfort 27.17 9.69 323 300623 125294 79318148
Myelosuppression 27.00 9.69 71 300875 40225 79403217
Accidental poisoning 26.50 9.69 32 300914 1625 79441817
Palpitations 26.45 9.69 328 300618 126282 79317160
Stupor 26.44 9.69 71 300875 6801 79436641
Tonsillar disorder 26.29 9.69 28 300918 1238 79442204
Implant site extravasation 26.25 9.69 23 300923 796 79442646
Bone erosion 26.23 9.69 135 300811 17712 79425730
Gastrooesophageal reflux disease 26.17 9.69 259 300687 103987 79339455
Vascular resistance systemic decreased 26.09 9.69 14 300932 211 79443231
Carcinoid crisis 26 9.69 19 300927 504 79442938
Diabetes mellitus 25.93 9.69 181 300765 78209 79365233
Neuralgia 25.91 9.69 215 300731 33169 79410273
Bone marrow failure 25.91 9.69 102 300844 51005 79392437
Breast cancer female 25.40 9.69 6 300940 11455 79431987
Faecal volume decreased 25.00 9.69 13 300933 183 79443259
Urinary tract infection 24.81 9.69 818 300128 273694 79169748
Anaphylactic reaction 24.74 9.69 449 300497 83294 79360148
Blood glucose increased 24.73 9.69 296 300650 114679 79328763
Neuroblastoma 24.71 9.69 14 300932 236 79443206
Abdominal pain 24.69 9.69 1747 299199 387822 79055620
Sepsis neonatal 24.67 9.69 9 300937 49 79443393
Heavy menstrual bleeding 24.61 9.69 11 300935 14000 79429442
Throat irritation 24.60 9.69 76 300870 40870 79402572
Iron deficiency anaemia 24.27 9.69 37 300909 25635 79417807
Back pain 24.19 9.69 1391 299555 302789 79140653
Basal cell carcinoma 24.18 9.69 67 300879 37308 79406134
Diffuse axonal injury 24.11 9.69 11 300935 114 79443328
Gout 24.05 9.69 35 300911 24714 79418728
Sternal fracture 24.04 9.69 38 300908 2492 79440950
Myocardial fibrosis 23.99 9.69 31 300915 1687 79441755
Sleep disorder due to a general medical condition 23.86 9.69 12 300934 14265 79429177
Herpes simplex viraemia 23.83 9.69 17 300929 434 79443008
Gangrene 23.56 9.69 81 300865 8883 79434559
Hypoacusis 23.51 9.69 49 300897 30101 79413341
Buttock injury 23.46 9.69 12 300934 163 79443279
Coma scale abnormal 23.32 9.69 79 300867 8599 79434843
Aplastic anaemia 23.30 9.69 131 300815 17774 79425668
Cushingoid 23.26 9.69 4 300942 9548 79433894
Glycosylated haemoglobin increased 23.22 9.69 23 300923 19237 79424205
Liver disorder 23.08 9.69 169 300777 72248 79371194
Product name confusion 23.08 9.69 12 300934 169 79443273
Rhythm idioventricular 23.03 9.69 19 300927 605 79442837
Colitis microscopic 23.00 9.69 91 300855 10677 79432765
Hallucination, visual 22.90 9.69 206 300740 32523 79410919
Dermatitis atopic 22.82 9.69 5 300941 10051 79433391
Device difficult to use 22.75 9.69 11 300935 13374 79430068
Blood alkaline phosphatase increased 22.71 9.69 352 300594 63312 79380130
Infective pulmonary exacerbation of cystic fibrosis 22.71 9.69 10 300936 12841 79430601
Administration site abscess 22.71 9.69 7 300939 20 79443422
Pemphigoid 22.57 9.69 15 300931 15300 79428142
Calcium deficiency 22.52 9.69 22 300924 877 79442565
Tumour pain 22.49 9.69 35 300911 2264 79441178
Gallbladder cholesterolosis 22.45 9.69 19 300927 627 79442815
Infusion site granuloma 22.45 9.69 6 300940 8 79443434
White blood cell count decreased 22.39 9.69 540 300406 187748 79255694
Spinal cord injury 22.35 9.69 26 300920 1269 79442173
Blood cholesterol increased 22.29 9.69 205 300741 83515 79359927
Hyponatraemia 22.28 9.69 506 300440 177342 79266100
Thrombotic microangiopathy 22.19 9.69 26 300920 20143 79423299
Drug eruption 22.07 9.69 88 300858 43847 79399595
Injection site bruising 21.97 9.69 80 300866 40922 79402520
Vision blurred 21.88 9.69 275 300671 105623 79337819
Occupational dermatitis 21.86 9.69 11 300935 144 79443298
Haematotoxicity 21.81 9.69 16 300930 15503 79427939
Apnoeic attack 21.75 9.69 19 300927 655 79442787
Neurological examination abnormal 21.66 9.69 18 300928 579 79442863
Drug level 21.65 9.69 6 300940 10 79443432
Asthma 21.57 9.69 369 300577 134726 79308716
Metastasis 21.54 9.69 66 300880 6814 79436628
Pulseless electrical activity 21.43 9.69 108 300838 14052 79429390
Alveolitis 21.19 9.69 48 300898 4132 79439310
Neuroblastoma recurrent 21.14 9.69 12 300934 203 79443239
Intentional self-injury 21.06 9.69 58 300888 32361 79411081
Amnestic disorder 20.97 9.69 18 300928 606 79442836
Hepatocellular injury 20.93 9.69 273 300673 47320 79396122
Administration site discharge 20.92 9.69 7 300939 28 79443414
PO2 decreased 20.90 9.69 39 300907 2924 79440518
Body temperature increased 20.89 9.69 258 300688 44162 79399280
Systemic mastocytosis 20.85 9.69 14 300932 323 79443119
Failure to suspend medication 20.85 9.69 16 300930 458 79442984
Drug tolerance increased 20.64 9.69 18 300928 619 79442823
Anaesthetic complication 20.63 9.69 38 300908 2821 79440621
Bladder cancer 20.61 9.69 26 300920 19500 79423942
Enthesopathy 20.57 9.69 9 300937 11599 79431843
Implant site discharge 20.48 9.69 11 300935 166 79443276
Victim of homicide 20.43 9.69 11 300935 167 79443275
Administration site induration 20.36 9.69 7 300939 31 79443411
Squamous cell carcinoma of skin 20.34 9.69 14 300932 14019 79429423
Psoriatic arthropathy 20.33 9.69 192 300754 77807 79365635
Low density lipoprotein increased 20.16 9.69 4 300942 8618 79434824
Cardiac murmur 20.13 9.69 18 300928 15806 79427636
Joint effusion 20.06 9.69 23 300923 17991 79425451
Nodule 20.00 9.69 35 300911 22959 79420483
Clonus 19.93 9.69 64 300882 6776 79436666
Myelodysplastic syndrome 19.84 9.69 54 300892 30247 79413195
No adverse event 19.64 9.69 73 300873 37119 79406323
Salivary hypersecretion 19.56 9.69 15 300931 14209 79429233
Administration site odour 19.51 9.69 7 300939 36 79443406
Haematuria 19.45 9.69 166 300780 68670 79374772
Device programming error 19.43 9.69 11 300935 185 79443257
Anaesthesia 19.35 9.69 16 300930 511 79442931
Sepsis 19.33 9.69 1221 299725 268207 79175235
Nephrotic syndrome 19.27 9.69 9 300937 11165 79432277
Duodenal ulcer 19.22 9.69 20 300926 16349 79427093
Haemophagocytic lymphohistiocytosis 19.21 9.69 33 300913 21804 79421638
Wheezing 19.17 9.69 317 300629 116347 79327095
Inflammation 19.16 9.69 244 300702 93509 79349933
Disease progression 19.14 9.69 865 300081 183497 79259945
Tachycardia 19.10 9.69 837 300109 176931 79266511
Femur fracture 19.05 9.69 78 300868 38574 79404868
Cerebral infarction 19.04 9.69 98 300848 45578 79397864
Administration site haemorrhage 19.02 9.69 8 300938 67 79443375
Agonal death struggle 19.00 9.69 5 300941 6 79443436
Red blood cell count decreased 18.92 9.69 133 300813 57380 79386062
Epstein-Barr virus infection 18.83 9.69 16 300930 14400 79429042
Multiple-drug resistance 18.77 9.69 5 300941 8803 79434639
Delusion of grandeur 18.70 9.69 25 300921 1407 79442035
Pulmonary toxicity 18.56 9.69 13 300933 12901 79430541
Chronic spontaneous urticaria 18.54 9.69 23 300923 1201 79442241
Mucosal inflammation 18.53 9.69 394 300552 75186 79368256
Splenic injury 18.53 9.69 12 300934 260 79443182
Blood pH increased 18.49 9.69 24 300922 1312 79442130
Joint range of motion decreased 18.46 9.69 64 300882 33218 79410224
Pneumonia viral 18.45 9.69 76 300870 9082 79434360
Type 2 diabetes mellitus 18.35 9.69 133 300813 56989 79386453
Dry skin 18.32 9.69 166 300780 67829 79375613
Erythema 18.18 9.69 674 300272 222616 79220826
Blood chromogranin A increased 17.93 9.69 15 300931 487 79442955
Hypothermia 17.92 9.69 147 300799 22599 79420843
Lip dry 17.92 9.69 19 300927 15399 79428043
Polyarthritis 17.91 9.69 12 300934 12190 79431252
Mitral valve incompetence 17.90 9.69 52 300894 28513 79414929
Substance dependence 17.88 9.69 15 300931 489 79442953
Head discomfort 17.86 9.69 17 300929 14485 79428957
Pathological fracture 17.84 9.69 83 300863 10454 79432988
Increased bronchial secretion 17.76 9.69 39 300907 3288 79440154
Iodine allergy 17.76 9.69 16 300930 575 79442867
Aspergillus infection 17.75 9.69 28 300918 19133 79424309
Antinuclear antibody positive 17.75 9.69 4 300942 7886 79435556
Product quality issue 17.68 9.69 67 300879 33873 79409569
Pulmonary tuberculosis 17.67 9.69 4 300942 7861 79435581
Photosensitivity reaction 17.62 9.69 33 300913 21094 79422348
Oesophageal carcinoma 17.52 9.69 10 300936 11074 79432368
Maternal exposure during pregnancy 17.51 9.69 387 300559 136151 79307291
Hepatic cirrhosis 17.40 9.69 205 300741 34701 79408741
Breast cancer 17.39 9.69 67 300879 33714 79409728
Neuroleptic malignant syndrome 17.39 9.69 50 300896 27509 79415933
Hypogammaglobulinaemia 17.37 9.69 14 300932 12937 79430505
Administration site erythema 17.37 9.69 13 300933 358 79443084
Tuberculosis 17.37 9.69 19 300927 15179 79428263
Squamous cell carcinoma 17.34 9.69 20 300926 15602 79427840
Asthenia 17.32 9.69 1679 299267 510010 78933432
Product monitoring error 17.27 9.69 6 300940 8900 79434542
Dependence 17.24 9.69 32 300914 2390 79441052
Neuroendocrine tumour of the lung 17.20 9.69 6 300940 28 79443414
Renal disorder 17.18 9.69 91 300855 42014 79401428
Alanine aminotransferase abnormal 17.15 9.69 6 300940 8861 79434581
Foot deformity 17.09 9.69 152 300794 23922 79419520
Feeling jittery 17.08 9.69 14 300932 12827 79430615
Vaginal flatulence 17.06 9.69 33 300913 2542 79440900
Proteinuria 17.03 9.69 64 300882 32438 79411004
Onychomycosis 17.03 9.69 5 300941 8256 79435186
Acute graft versus host disease in skin 16.99 9.69 4 300942 7654 79435788
Postmortem blood drug level increased 16.99 9.69 18 300928 791 79442651
Injection site cyst 16.96 9.69 8 300938 90 79443352
Blood immunoglobulin A decreased 16.92 9.69 24 300922 1429 79442013
Foetal monitoring abnormal 16.88 9.69 10 300936 184 79443258
Depression 16.85 9.69 658 300288 216132 79227310
Post stroke epilepsy 16.84 9.69 5 300941 12 79443430
Rheumatic disorder 16.84 9.69 37 300909 3121 79440321
Device failure 16.83 9.69 57 300889 6204 79437238
Cerebrospinal fluid leakage 16.81 9.69 26 300920 1673 79441769
Visual acuity reduced 16.80 9.69 56 300890 29413 79414029
Nervous system disorder 16.77 9.69 165 300781 26691 79416751
Wrong product administered 16.77 9.69 73 300873 8939 79434503
Product storage error 16.72 9.69 22 300924 16204 79427238
Reaction to excipient 16.69 9.69 25 300921 1564 79441878
End stage renal disease 16.66 9.69 13 300933 12207 79431235
Total lung capacity decreased 16.59 9.69 35 300911 2870 79440572
Parkinsonism 16.57 9.69 23 300923 16561 79426881
Medication error 16.56 9.69 357 300589 68285 79375157
Personality disorder 16.56 9.69 56 300890 6090 79437352
Gastrointestinal hypomotility 16.53 9.69 28 300918 1945 79441497
Substance use 16.53 9.69 19 300927 915 79442527
Chemical poisoning 16.50 9.69 10 300936 192 79443250
Angina unstable 16.43 9.69 23 300923 16504 79426938
Limb discomfort 16.37 9.69 66 300880 32784 79410658
Eosinophilia 16.36 9.69 102 300844 45243 79398199
Spinal epidural haemorrhage 16.24 9.69 9 300937 145 79443297
Anaemia 16.23 9.69 1452 299494 443563 78999879
Sensory loss 16.22 9.69 94 300852 12897 79430545
Abdominal pain upper 16.19 9.69 685 300261 223134 79220308
Infusion related reaction 16.16 9.69 707 300239 229530 79213912
Suicide attempt 16.16 9.69 218 300728 82714 79360728
Labelled drug-drug interaction medication error 16.14 9.69 52 300894 27598 79415844
Exercise tolerance decreased 16.12 9.69 7 300939 9064 79434378
Oropharyngeal pain 16.09 9.69 303 300643 109050 79334392
Product prescribing error 16.06 9.69 101 300845 44712 79398730
Immunosuppressant drug level increased 15.99 9.69 7 300939 9020 79434422
Hyperlipidaemia 15.99 9.69 48 300898 26045 79417397
Intensive care 15.93 9.69 20 300926 1057 79442385
Nasal polyps 15.92 9.69 4 300942 7323 79436119
Optic neuritis 15.91 9.69 8 300938 9512 79433930
Gastrointestinal motility disorder 15.81 9.69 55 300891 6067 79437375
Acute respiratory failure 15.79 9.69 314 300632 59227 79384215
Pneumocystis jirovecii pneumonia 15.77 9.69 66 300880 32442 79411000
Central nervous system injury 15.76 9.69 9 300937 154 79443288
Biliary obstruction 15.73 9.69 46 300900 4628 79438814
Fluid retention 15.67 9.69 178 300768 69631 79373811
Pain 15.63 9.69 2948 297998 700854 78742588
Surgery 15.60 9.69 67 300879 32699 79410743
Blood phosphorus decreased 15.60 9.69 58 300888 6610 79436832
Transplant dysfunction 15.58 9.69 4 300942 7217 79436225
Lactic acidosis 15.56 9.69 180 300766 70179 79373263
Acute myocardial infarction 15.56 9.69 201 300745 76835 79366607
Polyneuropathy in malignant disease 15.55 9.69 11 300935 277 79443165
Brain death 15.54 9.69 52 300894 5625 79437817
Retrograde amnesia 15.52 9.69 15 300931 590 79442852
Neuropathy peripheral 15.52 9.69 410 300536 140895 79302547
Hepatitis B 15.51 9.69 6 300940 8326 79435116
Paradoxical drug reaction 15.46 9.69 4 300942 7181 79436261
Internal haemorrhage 15.41 9.69 7 300939 8826 79434616
Parathyroid hormone-related protein abnormal 15.36 9.69 5 300941 18 79443424
Leukoencephalopathy 15.35 9.69 65 300881 7864 79435578
Respiratory tract infection 15.34 9.69 114 300832 48575 79394867
Radiculopathy 15.31 9.69 70 300876 8754 79434688
Urticaria thermal 15.28 9.69 13 300933 432 79443010
Secondary hypogonadism 15.24 9.69 12 300934 357 79443085
Basal ganglion degeneration 15.21 9.69 13 300933 435 79443007
Rash pruritic 15.17 9.69 185 300761 71444 79371998
Dysarthria 15.15 9.69 348 300598 67274 79376168
Carotid artery occlusion 15.10 9.69 5 300941 7642 79435800
Pain in extremity 15.01 9.69 1178 299768 363360 79080082
Cardiopulmonary failure 14.95 9.69 58 300888 6743 79436699
Acute graft versus host disease 14.92 9.69 10 300936 10157 79433285
Skin cancer 14.88 9.69 21 300925 15019 79428423
Cardiomyopathy 14.86 9.69 57 300889 28717 79414725
Hypogonadism 14.78 9.69 25 300921 1735 79441707
Breast cancer metastatic 14.75 9.69 68 300878 8534 79434908
Thirst decreased 14.73 9.69 11 300935 302 79443140
Drug-induced liver injury 14.68 9.69 169 300777 65948 79377494
Seronegative arthritis 14.68 9.69 45 300901 4647 79438795
Infection 14.63 9.69 754 300192 240958 79202484
Respiratory rate increased 14.63 9.69 135 300811 21465 79421977
Hostility 14.58 9.69 29 300917 2281 79441161
PO2 abnormal 14.57 9.69 5 300941 22 79443420
Demyelination 14.57 9.69 6 300940 8017 79435425
Soft tissue injury 14.56 9.69 25 300921 1756 79441686
Theft 14.44 9.69 10 300936 243 79443199
Vascular malformation 14.44 9.69 12 300934 386 79443056
Epidural analgesia 14.39 9.69 6 300940 49 79443393
Product use issue 14.38 9.69 646 300300 209176 79234266
Hypertensive crisis 14.38 9.69 36 300910 20734 79422708
Cytopenia 14.37 9.69 35 300911 20348 79423094
Medical device site infection 14.35 9.69 14 300932 557 79442885
Lupus vulgaris 14.34 9.69 36 300910 3310 79440132
Anal inflammation 14.31 9.69 22 300924 1408 79442034
Uveitis 14.29 9.69 26 300920 16804 79426638
Chest discomfort 14.26 9.69 404 300542 137640 79305802
Incubator therapy 14.19 9.69 6 300940 51 79443391
Vasculitis 14.10 9.69 48 300898 25054 79418388
Acute pulmonary oedema 14.06 9.69 97 300849 14133 79429309
Cardiac output decreased 13.99 9.69 25 300921 1813 79441629
Restlessness 13.98 9.69 250 300696 46242 79397200
Arachnoiditis 13.98 9.69 16 300930 767 79442675
Eye pruritus 13.97 9.69 36 300910 20534 79422908
Injection site induration 13.96 9.69 10 300936 9809 79433633
Metastases to eye 13.96 9.69 10 300936 257 79443185
Myoglobin urine 13.89 9.69 5 300941 26 79443416
Intentional dose omission 13.87 9.69 8 300938 8809 79434633
Hypopnoea 13.87 9.69 48 300898 5281 79438161
Tissue infiltration 13.85 9.69 15 300931 676 79442766
Kidney transplant rejection 13.84 9.69 11 300935 10235 79433207
Infusion site pain 13.82 9.69 20 300926 14156 79429286
Cardiac failure chronic 13.77 9.69 13 300933 11122 79432320
Pulmonary haemorrhage 13.77 9.69 99 300847 14618 79428824
Opiates 13.75 9.69 3 300943 0 79443442
Femoral pulse abnormal 13.75 9.69 3 300943 0 79443442
COVID-19 pneumonia 13.73 9.69 59 300887 28790 79414652
Iron deficiency 13.70 9.69 12 300934 10642 79432800
Bronchopulmonary aspergillosis 13.67 9.69 41 300905 22253 79421189
Hallucination, tactile 13.60 9.69 14 300932 595 79442847
Scan gallium abnormal 13.59 9.69 5 300941 28 79443414
Bronchitis 13.59 9.69 382 300564 130262 79313180
Cytomegalovirus infection reactivation 13.58 9.69 8 300938 8708 79434734
Laboratory test abnormal 13.57 9.69 57 300889 27991 79415451
Ileus 13.54 9.69 155 300791 26056 79417386
Paraesthesia 13.52 9.69 536 300410 175787 79267655
Brain injury 13.52 9.69 82 300864 11435 79432007
Lymphocyte count abnormal 13.49 9.69 22 300924 1481 79441961
Needle issue 13.46 9.69 90 300856 12978 79430464
Proctitis 13.45 9.69 54 300892 6378 79437064
Tooth injury 13.45 9.69 26 300920 2002 79441440
Peripheral nerve injury 13.45 9.69 15 300931 699 79442743
Lupus-like syndrome 13.42 9.69 94 300852 13763 79429679
Blood triglycerides increased 13.40 9.69 38 300908 21002 79422440
Deformity 13.37 9.69 10 300936 9595 79433847
Cheyne-Stokes respiration 13.35 9.69 13 300933 516 79442926
Megacolon 13.34 9.69 36 300910 3459 79439983
Injection site discolouration 13.34 9.69 6 300940 7608 79435834
Performance status decreased 13.33 9.69 52 300894 6061 79437381
Large intestine polyp 13.33 9.69 17 300929 12691 79430751
Foetal arrhythmia 13.25 9.69 6 300940 61 79443381
Fear-related avoidance of activities 13.25 9.69 7 300939 102 79443340
Malignant melanoma 13.22 9.69 22 300924 14719 79428723
Substance use disorder 13.22 9.69 17 300929 921 79442521
Joint injury 13.19 9.69 67 300879 31268 79412174
Bacterial infection 13.10 9.69 67 300879 31213 79412229
Stroke volume increased 13.09 9.69 4 300942 11 79443431
Lymphopenia 13.06 9.69 65 300881 30492 79412950
Paranasal cyst 13.05 9.69 12 300934 443 79442999
Anamnestic reaction 13.03 9.69 5 300941 32 79443410
Hypohidrosis 13.01 9.69 10 300936 287 79443155
Thymus disorder 13.01 9.69 10 300936 287 79443155
Cardiac pacemaker insertion 13.00 9.69 3 300943 5819 79437623
Nephropathy toxic 12.92 9.69 37 300909 20382 79423060
Laryngitis 12.82 9.69 104 300842 15935 79427507
Dyslipidaemia 12.79 9.69 15 300931 11618 79431824
Excessive eye blinking 12.77 9.69 23 300923 1678 79441764
Consciousness fluctuating 12.76 9.69 25 300921 1944 79441498
Bladder dilatation 12.65 9.69 26 300920 2093 79441349
Electrocardiogram low voltage 12.65 9.69 5 300941 35 79443407
Dose calculation error 12.61 9.69 9 300937 230 79443212
Intentional misuse of drug delivery system 12.60 9.69 4 300942 13 79443429
Cytomegalovirus viraemia 12.59 9.69 18 300928 12803 79430639
Dehydration 12.58 9.69 1094 299852 247093 79196349
Diabetes mellitus inadequate control 12.57 9.69 48 300898 24216 79419226
Head injury 12.50 9.69 86 300860 37283 79406159
Drug dose omission by device 12.49 9.69 4 300942 6246 79437196
Libido increased 12.48 9.69 25 300921 1976 79441466
Night sweats 12.43 9.69 131 300815 51964 79391478
Skin disorder 12.43 9.69 76 300870 33867 79409575
Paraparesis 12.39 9.69 37 300909 3766 79439676
Glomerular filtration rate decreased 12.36 9.69 44 300902 22658 79420784
Knee arthroplasty 12.35 9.69 104 300842 43144 79400298
Product dose omission in error 12.35 9.69 7 300939 7781 79435661
Lymphoproliferative disorder 12.33 9.69 3 300943 5612 79437830
Pocket erosion 12.30 9.69 5 300941 38 79443404
Rhinitis allergic 12.27 9.69 17 300929 12252 79431190
Blood loss anaemia 12.24 9.69 25 300921 15473 79427969
Appendicitis 12.21 9.69 39 300907 20755 79422687
Skin fissures 12.21 9.69 19 300927 13054 79430388
Psychotic behaviour 12.20 9.69 18 300928 1111 79442331
Keratitis 12.19 9.69 40 300906 4282 79439160
Metastases to spine 12.18 9.69 40 300906 4284 79439158
Therapy partial responder 12.16 9.69 30 300916 17367 79426075
Temperature regulation disorder 12.13 9.69 49 300897 5804 79437638
Antasthmatic drug level 12.08 9.69 5 300941 40 79443402
Amenorrhoea 12.07 9.69 7 300939 7685 79435757
Hyperreflexia 12.03 9.69 63 300883 8322 79435120
Gastrointestinal haemorrhage 11.99 9.69 446 300500 147273 79296169
Jaundice 11.99 9.69 136 300810 53213 79390229
Oesophagitis chemical 11.96 9.69 6 300940 78 79443364
Flushing 11.95 9.69 248 300698 88020 79355422
Breath sounds abnormal 11.90 9.69 102 300844 15882 79427560
Pulse absent 11.90 9.69 72 300874 10031 79433411
Coronary artery bypass 11.90 9.69 4 300942 6058 79437384
Upper-airway cough syndrome 11.90 9.69 16 300930 11677 79431765
Gastric dilatation 11.89 9.69 20 300926 1382 79442060
Paraplegia 11.86 9.69 44 300902 5009 79438433
Actinic keratosis 11.84 9.69 4 300942 6038 79437404
Device use error 11.82 9.69 6 300940 7095 79436347
Delayed recovery from anaesthesia 11.78 9.69 22 300924 1651 79441791
Suicidal ideation 11.71 9.69 210 300736 76130 79367312
Akathisia 11.70 9.69 20 300926 13239 79430203
Respiratory paralysis 11.70 9.69 6 300940 82 79443360
Subarachnoid haemorrhage 11.67 9.69 50 300896 24415 79419027
Hypomania 11.65 9.69 7 300939 7537 79435905
Hip arthroplasty 11.61 9.69 83 300863 35673 79407769
Device toxicity 11.58 9.69 4 300942 18 79443424
Female genital tract fistula 11.58 9.69 49 300897 5926 79437516
Vertigo 11.58 9.69 187 300759 68895 79374547
Analgesic drug level 11.57 9.69 5 300941 45 79443397
Therapeutic response decreased 11.53 9.69 180 300766 66673 79376769
Tongue disorder 11.51 9.69 22 300924 13953 79429489
Adverse event 11.47 9.69 159 300787 60055 79383387
Hypertransaminasaemia 11.45 9.69 17 300929 11907 79431535
Muscle swelling 11.42 9.69 15 300931 830 79442612
Haemorrhagic stroke 11.36 9.69 15 300931 11031 79432411
Cardiac disorder 11.36 9.69 177 300769 65580 79377862
Spinal cord paralysis 11.35 9.69 7 300939 139 79443303
Perineal pain 11.33 9.69 17 300929 1065 79442377
Fibrinolysis 11.32 9.69 6 300940 88 79443354
Septic necrosis 11.26 9.69 6 300940 89 79443353
Abdominal compartment syndrome 11.24 9.69 21 300925 1576 79441866
Acute respiratory distress syndrome 11.22 9.69 231 300715 43836 79399606
Pituitary apoplexy 11.19 9.69 8 300938 205 79443237
Skin reaction 11.17 9.69 101 300845 15967 79427475
Bronchopulmonary aspergillosis allergic 11.15 9.69 31 300915 3030 79440412
Erythema multiforme 11.15 9.69 32 300914 17619 79425823
Injection site extravasation 11.15 9.69 12 300934 9657 79433785
Pain in jaw 11.03 9.69 116 300830 46035 79397407
Increased tendency to bruise 10.97 9.69 14 300932 10450 79432992
Cutaneous vasculitis 10.97 9.69 9 300937 8243 79435199
Cluster headache 10.94 9.69 16 300930 980 79442462
Peripheral ischaemia 10.89 9.69 67 300879 9390 79434052
SARS-CoV-2 test negative 10.89 9.69 19 300927 1352 79442090
Red cell distribution width increased 10.88 9.69 26 300920 15216 79428226
Retinal haemorrhage 10.88 9.69 9 300937 8208 79435234
Large intestine perforation 10.87 9.69 93 300853 14474 79428968
Stridor 10.79 9.69 45 300901 5408 79438034
Anorgasmia 10.78 9.69 18 300928 1236 79442206
Epidural haemorrhage 10.76 9.69 8 300938 218 79443224
Nocardiosis 10.72 9.69 4 300942 5675 79437767
Intercepted product dispensing error 10.72 9.69 7 300939 154 79443288
Rhinalgia 10.71 9.69 26 300920 2341 79441101
Tension headache 10.71 9.69 7 300939 7204 79436238
Obesity 10.70 9.69 83 300863 35042 79408400
Dermo-hypodermitis 10.66 9.69 14 300932 774 79442668
Mastoid disorder 10.64 9.69 4 300942 24 79443418
Catheter site phlebitis 10.64 9.69 4 300942 24 79443418
Monocytopenia 10.60 9.69 7 300939 157 79443285
Dysphagia 10.57 9.69 563 300383 121573 79321869
Post-traumatic neck syndrome 10.56 9.69 24 300922 2070 79441372
Urine alcohol test positive 10.50 9.69 4 300942 25 79443417
Analgesic drug level above therapeutic 10.48 9.69 11 300935 478 79442964
Foetal megacystis 10.48 9.69 3 300943 6 79443436
Intrapericardial thrombosis 10.47 9.69 5 300941 58 79443384
Catheter site granuloma 10.47 9.69 5 300941 58 79443384
Optic nerve operation 10.46 9.69 11 300935 479 79442963
Adiposis dolorosa 10.46 9.69 9 300937 304 79443138
Phlebitis 10.45 9.69 63 300883 8767 79434675
Tongue oedema 10.45 9.69 7 300939 7110 79436332
Graft versus host disease 10.43 9.69 26 300920 15000 79428442
Gait disturbance 10.42 9.69 659 300287 206847 79236595
Abortion induced 10.42 9.69 7 300939 7102 79436340
Nephrosclerosis 10.40 9.69 22 300924 1808 79441634
Proctalgia 10.37 9.69 69 300877 9932 79433510
Abdominal wall mass 10.37 9.69 4 300942 26 79443416
Rheumatoid factor positive 10.36 9.69 161 300785 59678 79383764
Device computer issue 10.34 9.69 6 300940 106 79443336
Abnormal behaviour 10.31 9.69 194 300752 36227 79407215
Device issue 10.29 9.69 60 300886 27048 79416394
Eye haemorrhage 10.29 9.69 13 300933 9744 79433698
Laryngectomy 10.25 9.69 4 300942 27 79443415
Vitamin D decreased 10.21 9.69 13 300933 9712 79433730
Coronavirus infection 10.19 9.69 8 300938 7489 79435953
Neurotoxicity 10.19 9.69 176 300770 32342 79411100
Muscular weakness 10.18 9.69 499 300447 160230 79283212
Mediastinal shift 10.18 9.69 5 300941 62 79443380
Anaemia of malignant disease 10.16 9.69 14 300932 811 79442631
Inappropriate antidiuretic hormone secretion 10.12 9.69 58 300888 26255 79417187
Infusion site extravasation 10.11 9.69 14 300932 10094 79433348
Eosinophil count increased 10.10 9.69 32 300914 17073 79426369
Electroencephalogram abnormal 10.10 9.69 44 300902 5390 79438052
Visceral oedema 10.10 9.69 6 300940 111 79443331
Inappropriate schedule of product administration 10.07 9.69 407 300539 133221 79310221
Scrotal infection 10.07 9.69 12 300934 601 79442841
Disease prodromal stage 10.04 9.69 5 300941 64 79443378
Hepatic pain 10.01 9.69 36 300910 4036 79439406
Intraocular pressure increased 9.98 9.69 12 300934 9193 79434249
Cholestatic liver injury 9.95 9.69 41 300905 4900 79438542
Blood pressure diastolic increased 9.90 9.69 91 300855 14451 79428991
General physical condition abnormal 9.89 9.69 50 300896 6513 79436929
Acne 9.89 9.69 61 300885 27129 79416313
Decerebration 9.87 9.69 6 300940 116 79443326
Nerve injury 9.86 9.69 65 300881 9327 79434115
Dysgeusia 9.84 9.69 154 300792 57023 79386419
Faecaloma 9.80 9.69 76 300870 11488 79431954
Incision site erythema 9.80 9.69 11 300935 516 79442926
Clumsiness 9.79 9.69 30 300916 3097 79440345
Blood creatine phosphokinase MB increased 9.79 9.69 28 300918 2783 79440659
Urticaria aquagenic 9.77 9.69 4 300942 31 79443411
Diplopia 9.77 9.69 80 300866 33386 79410056
Medical device site haemorrhage 9.77 9.69 7 300939 180 79443262
Skin papilloma 9.76 9.69 5 300941 5881 79437561
Ileus paralytic 9.76 9.69 66 300880 9554 79433888
Vulvovaginal candidiasis 9.70 9.69 26 300920 2488 79440954

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




🐶 Veterinary Drug Use

None

🐶 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 **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** 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 **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** 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 **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** 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 **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** 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 **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** 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 **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** 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 **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** 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 TREATMENT BY ORALLY ADMINISTERING AN INTACT COMPOSITION AS CLAIMED.
100MG;4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** 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 TREATMENT BY ORALLY ADMINISTERING AN INTACT COMPOSITION AS CLAIMED.
20MG;0.8MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** 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 TREATMENT BY ORALLY ADMINISTERING AN INTACT COMPOSITION AS CLAIMED.
20MG;0.8MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** 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 TREATMENT BY ORALLY ADMINISTERING AN INTACT COMPOSITION AS CLAIMED.
30MG;1.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** 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 TREATMENT BY ORALLY ADMINISTERING AN INTACT COMPOSITION AS CLAIMED.
30MG;1.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** 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 TREATMENT BY ORALLY ADMINISTERING AN INTACT COMPOSITION AS CLAIMED.
50MG;2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** 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 TREATMENT BY ORALLY ADMINISTERING AN INTACT COMPOSITION AS CLAIMED.
50MG;2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** 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 TREATMENT BY ORALLY ADMINISTERING AN INTACT COMPOSITION AS CLAIMED.
60MG;2.4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** 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 TREATMENT BY ORALLY ADMINISTERING AN INTACT COMPOSITION AS CLAIMED.
60MG;2.4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** 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 TREATMENT BY ORALLY ADMINISTERING AN INTACT COMPOSITION AS CLAIMED.
80MG;3.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** 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 TREATMENT BY ORALLY ADMINISTERING AN INTACT COMPOSITION AS CLAIMED.
80MG;3.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** 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 TREATMENT BY ORALLY ADMINISTERING AN INTACT COMPOSITION AS CLAIMED.
100MG;4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** 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 **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** 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 **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** 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 **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** 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 **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** 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 **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** 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
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
Mu-type opioid receptor GPCR Ki 9.11 CHEMBL
Mu-type opioid receptor GPCR Ki 9.06 CHEMBL
Mu-type opioid receptor GPCR Ki 8.92 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
414779007 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 0054-0237 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 0054-0238 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 0115-1277 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 0115-1278 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 0115-1279 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 0115-1280 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