tramadol 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
analgesics 2711 27203-92-5

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • tramadol
  • (+/-)-Tramadol
  • racemic tramadol
  • tradolan
  • tramadon
  • tramadol hydrochloride
  • tramadol HCl
  • twotram
A narcotic analgesic proposed for severe pain. It may be habituating.
  • Molecular weight: 263.38
  • Formula: C16H25NO2
  • CLOGP: 3.10
  • LIPINSKI: 0
  • HAC: 3
  • HDO: 1
  • TPSA: 32.70
  • ALOGS: -2.55
  • ROTB: 4
  • Status: OFP
    • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
0.30 g O
0.30 g P
0.30 g R

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 1 Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 20 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 16.27 µM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 72.50 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution) 2.80 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 6.50 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.80 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 5.80 hours Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
March 3, 1995 FDA JANSSEN PHARMS
Sept. 25, 2020 PMDA NIPPON ZOKI PHARMACEUTICAL CO., LTD.

FDA Adverse Event Reporting System (Female)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Serotonin syndrome 776.44 9.48 702 217167 27980 63243173
Drug dependence 697.88 9.48 617 217252 23866 63247287
Drug abuse 643.84 9.48 1002 216867 71516 63199637
Poisoning deliberate 605.83 9.48 413 217456 10805 63260348
Toxicity to various agents 601.39 9.48 2040 215829 245210 63025943
Pemphigus 427.75 9.48 61 217808 183665 63087488
Drug hypersensitivity 420.56 9.48 2141 215728 308546 62962607
Completed suicide 403.28 9.48 1257 216612 144416 63126737
Coma 323.09 9.48 695 217174 63669 63207484
Glossodynia 322.26 9.48 106 217763 178770 63092383
Hand deformity 315.80 9.48 79 217790 159378 63111775
Systemic lupus erythematosus 310.24 9.48 165 217704 208753 63062400
Contraindicated product administered 296.14 9.48 191 217678 217457 63053696
Intentional overdose 289.06 9.48 725 217144 73427 63197726
Somnolence 271.81 9.48 1274 216595 177411 63093742
Withdrawal syndrome 255.47 9.48 329 217540 19668 63251485
Deafness transitory 255.24 9.48 128 217741 1842 63269311
Bradypnoea 254.01 9.48 156 217713 3394 63267759
Prescription form tampering 251.54 9.48 89 217780 489 63270664
Overdose 241.02 9.48 905 216964 114173 63156980
Infusion related reaction 238.64 9.48 295 217574 245226 63025927
Pericarditis 231.67 9.48 81 217788 131498 63139655
Maternal exposure during pregnancy 230.49 9.48 249 217620 219813 63051340
Drug interaction 218.58 9.48 1440 216429 227691 63043462
Gastrointestinal pain 214.32 9.48 213 217656 9563 63261590
Synovitis 212.33 9.48 197 217672 186721 63084432
Treatment failure 212.03 9.48 222 217647 198821 63072332
Alopecia 210.16 9.48 536 217333 337000 62934153
Drug withdrawal syndrome 206.14 9.48 350 217519 26844 63244309
Anti-cyclic citrullinated peptide antibody positive 202.08 9.48 73 217796 116139 63155014
Drug intolerance 192.22 9.48 490 217379 308171 62962982
Wound 190.26 9.48 168 217701 163095 63108058
Drug use disorder 186.36 9.48 147 217722 4837 63266316
Drug ineffective 185.18 9.48 2504 215365 1042261 62228892
Sensitisation 178.87 9.48 123 217746 3263 63267890
Joint swelling 167.88 9.48 570 217299 327096 62944057
Hepatic enzyme increased 167.82 9.48 272 217597 202056 63069097
Discomfort 165.82 9.48 198 217671 167176 63103977
Off label use 165.44 9.48 1500 216369 672962 62598191
Miosis 164.51 9.48 162 217707 7191 63263962
Respiratory depression 158.74 9.48 215 217654 13500 63257653
Mydriasis 157.90 9.48 200 217669 11756 63259397
Polycystic ovaries 152.58 9.48 125 217744 4346 63266807
Ejection fraction 147.80 9.48 96 217773 2310 63268843
Helicobacter infection 142.51 9.48 70 217799 92715 63178438
Rheumatoid factor positive 141.75 9.48 56 217813 84350 63186803
Therapeutic product effect decreased 140.23 9.48 282 217587 192905 63078248
Duodenal ulcer perforation 139.80 9.48 62 217807 87147 63184006
Intentional product misuse 125.72 9.48 477 217392 60440 63210713
Hepatocellular injury 125.28 9.48 285 217584 27096 63244057
Suicide attempt 120.80 9.48 471 217398 60447 63210706
Rash 120.27 9.48 1288 216581 559583 62711570
Exposure during pregnancy 107.01 9.48 234 217635 155313 63115840
Arthropathy 104.14 9.48 433 217436 234359 63036794
Product use issue 103.94 9.48 397 217472 220123 63051030
Abdominal discomfort 103.76 9.48 660 217209 320225 62950928
Shoulder arthroplasty 102.48 9.48 95 217774 3907 63267246
Fall 101.88 9.48 1901 215968 390433 62880720
Vomiting 101.10 9.48 2573 215296 557044 62714109
Blood test abnormal 100.23 9.48 187 217682 15442 63255711
Pharyngitis 97.01 9.48 214 217655 19929 63251224
Muscle injury 94.86 9.48 53 217816 65292 63205861
Rhinitis allergic 88.95 9.48 151 217718 11576 63259577
Swelling 88.69 9.48 567 217302 274811 62996342
Hallucination 81.11 9.48 388 217481 54429 63216724
Carpal tunnel syndrome 80.49 9.48 203 217666 20614 63250539
Folliculitis 79.90 9.48 74 217795 70243 63200910
Derealisation 78.65 9.48 50 217819 1158 63269995
Device expulsion 77.99 9.48 13 217856 34909 63236244
Functional gastrointestinal disorder 77.52 9.48 84 217785 4175 63266978
Dependence 74.96 9.48 60 217809 2017 63269136
Cholestasis 74.93 9.48 247 217622 29187 63241966
Sleep apnoea syndrome 71.96 9.48 242 217627 28891 63242262
Impaired healing 71.55 9.48 153 217716 102389 63168764
Depersonalisation/derealisation disorder 70.50 9.48 49 217820 1323 63269830
Nausea 68.80 9.48 3585 214284 850886 62420267
Asphyxia 67.17 9.48 94 217775 6087 63265066
Generalised tonic-clonic seizure 66.41 9.48 235 217634 28781 63242372
Cardio-respiratory arrest 64.58 9.48 389 217480 59570 63211583
Red blood cell sedimentation rate increased 63.36 9.48 36 217833 43946 63227207
Abnormal loss of weight 62.93 9.48 88 217781 5694 63265459
Drug detoxification 62.79 9.48 28 217841 304 63270849
Hallucination, visual 62.28 9.48 176 217693 19122 63252031
Feeding disorder 62.14 9.48 140 217729 13222 63257931
Infection 60.63 9.48 499 217370 228674 63042479
Ejection fraction abnormal 59.02 9.48 49 217820 1736 63269417
Hypersensitivity 58.23 9.48 683 217186 292002 62979151
Analgesic drug level increased 58.23 9.48 55 217814 2317 63268836
Lower respiratory tract infection 57.99 9.48 245 217624 132062 63139091
Prescription drug used without a prescription 57.95 9.48 55 217814 2331 63268822
Gastric pH decreased 57.91 9.48 35 217834 739 63270414
Drug abuser 57.36 9.48 60 217809 2863 63268290
Drug diversion 56.21 9.48 37 217832 911 63270242
Seizure 55.75 9.48 698 217171 131936 63139217
Respiratory acidosis 55.67 9.48 90 217779 6625 63264528
Red blood cell sedimentation rate abnormal 55.54 9.48 3 217866 19779 63251374
Irritable bowel syndrome 54.19 9.48 127 217742 82285 63188868
Clonus 54.14 9.48 73 217796 4563 63266590
Pyrexia 53.33 9.48 1219 216650 469259 62801894
Nephrectomy 53.23 9.48 43 217826 1465 63269688
Burning sensation 52.99 9.48 344 217525 54063 63217090
Foot operation 52.07 9.48 91 217778 7140 63264013
Mycotic allergy 51.73 9.48 36 217833 974 63270179
Ear infection 51.21 9.48 263 217606 37950 63233203
Dizziness 50.43 9.48 1876 215993 428049 62843104
Depression 50.13 9.48 950 216919 195542 63075611
Hyponatraemia 48.79 9.48 593 217276 111307 63159846
Poisoning 48.24 9.48 129 217740 13571 63257582
Confusional state 47.95 9.48 1105 216764 235275 63035878
Victim of chemical submission 47.56 9.48 27 217842 505 63270648
Sleep disorder due to general medical condition, insomnia type 47.30 9.48 66 217803 52151 63219002
Sleep disorder due to a general medical condition 47.27 9.48 119 217750 12069 63259084
Hypophagia 46.04 9.48 221 217648 31038 63240115
Suicidal ideation 45.95 9.48 369 217500 62052 63209101
Feeling of despair 45.88 9.48 48 217821 2291 63268862
Loss of consciousness 45.17 9.48 611 217258 117510 63153643
Hyperhidrosis 45.09 9.48 567 217302 107269 63163884
Agitation 44.39 9.48 354 217515 59403 63211750
Constipation 44.23 9.48 1047 216822 223896 63047257
H1N1 influenza 43.99 9.48 41 217828 1698 63269455
Abortion spontaneous 43.40 9.48 59 217810 47136 63224017
Disorientation 43.15 9.48 257 217612 39195 63231958
Decorticate posture 42.90 9.48 21 217848 286 63270867
Hyperacusis 42.59 9.48 44 217825 2069 63269084
Somatic symptom disorder 42.48 9.48 49 217820 2611 63268542
Chronic kidney disease 42.36 9.48 284 217585 45114 63226039
Pain 42.21 9.48 2095 215774 738533 62532620
Myoclonus 42.04 9.48 135 217734 15733 63255420
Multiple drug therapy 41.95 9.48 57 217812 3589 63267564
Respiratory arrest 41.89 9.48 222 217647 32423 63238730
Vertigo 41.38 9.48 349 217520 59538 63211615
Urinary retention 40.92 9.48 209 217660 30092 63241061
Myocardial depression 40.86 9.48 24 217845 480 63270673
Blister 40.85 9.48 269 217600 129545 63141608
Muscle rigidity 40.20 9.48 108 217761 11392 63259761
Deafness 39.87 9.48 144 217725 17813 63253340
Delirium 39.53 9.48 303 217566 50238 63220915
Cyanosis 39.48 9.48 138 217731 16797 63254356
Peripheral circulatory failure 39.34 9.48 30 217839 938 63270215
Encephalopathy 39.34 9.48 247 217622 38373 63232780
Dissociation 38.81 9.48 49 217820 2870 63268283
Acute generalised exanthematous pustulosis 38.57 9.48 104 217765 10995 63260158
Drug tolerance decreased 37.93 9.48 7 217862 17466 63253687
Myelosuppression 37.74 9.48 17 217852 23686 63247467
Headache 37.36 9.48 2586 215283 630655 62640498
Intentional product use issue 36.81 9.48 272 217597 127620 63143533
Speech disorder 36.62 9.48 252 217617 40377 63230776
Musculoskeletal disorder 36.44 9.48 154 217715 20490 63250663
Rheumatoid arthritis 36.10 9.48 633 217236 253186 63017967
Hypoglycaemia 35.83 9.48 339 217530 59726 63211427
Swollen joint count increased 35.29 9.48 43 217826 36011 63235142
Fracture 35.28 9.48 147 217722 19437 63251716
Rheumatoid nodule 34.91 9.48 8 217861 17147 63254006
Cogwheel rigidity 34.37 9.48 38 217831 1932 63269221
Renal disorder 34.28 9.48 212 217657 32762 63238391
Cryopyrin associated periodic syndrome 34.16 9.48 19 217850 341 63270812
Victim of sexual abuse 34.14 9.48 24 217845 660 63270493
Eyelid myoclonus 33.16 9.48 13 217856 99 63271054
Rheumatic fever 32.92 9.48 61 217808 43050 63228103
Drug resistance 32.70 9.48 19 217850 22914 63248239
Blood cholesterol increased 32.62 9.48 189 217680 93843 63177310
Ankylosing spondylitis 32.32 9.48 94 217775 10380 63260773
Pituitary tumour benign 32.28 9.48 37 217832 1958 63269195
Coma scale abnormal 32.22 9.48 61 217808 5092 63266061
Sphincter of Oddi dysfunction 32.21 9.48 19 217850 383 63270770
Disturbance in attention 32.16 9.48 233 217636 37956 63233197
Muscle spasms 31.96 9.48 731 217138 155419 63115734
Skin necrosis 31.58 9.48 5 217864 13945 63257208
Stomatitis 31.45 9.48 314 217555 138411 63132742
Pancreatic fibrosis 31.23 9.48 12 217857 86 63271067
Tonic clonic movements 30.96 9.48 31 217838 1404 63269749
Nightmare 30.69 9.48 139 217730 19055 63252098
Therapeutic product ineffective 30.60 9.48 34 217835 1738 63269415
Pancreatitis acute 30.37 9.48 178 217691 26988 63244165
Febrile neutropenia 30.34 9.48 260 217609 118189 63152964
Leukopenia 30.34 9.48 149 217720 77141 63194012
Psychotic disorder due to a general medical condition 30.18 9.48 16 217853 260 63270893
Hallucinations, mixed 29.99 9.48 57 217812 4772 63266381
Adverse reaction 29.99 9.48 90 217779 10113 63261040
Visceral congestion 29.71 9.48 17 217852 323 63270830
Acute motor-sensory axonal neuropathy 29.49 9.48 16 217853 273 63270880
Feeling of body temperature change 29.43 9.48 57 217812 4840 63266313
Limb injury 29.17 9.48 168 217701 25309 63245844
Fibromyalgia 29.11 9.48 412 217457 80008 63191145
Sacroiliitis 28.86 9.48 45 217824 3212 63267941
Hypothermia 28.54 9.48 107 217762 13474 63257679
Macular degeneration 28.46 9.48 25 217844 24351 63246802
Restless legs syndrome 28.01 9.48 132 217737 18399 63252754
Muscle disorder 27.65 9.48 56 217813 4913 63266240
Nasopharyngitis 27.55 9.48 663 217206 253594 63017559
Ill-defined disorder 27.47 9.48 166 217703 81589 63189564
Tremor 27.35 9.48 620 217249 131619 63139534
Anxiety 27.32 9.48 957 216912 216584 63054569
Drug eruption 27.27 9.48 35 217834 28659 63242494
Myocardial fibrosis 27.22 9.48 22 217847 750 63270403
Creatinine renal clearance decreased 27.07 9.48 11 217858 16297 63254856
Premature baby 27.07 9.48 19 217850 20716 63250437
Depressed level of consciousness 27.05 9.48 329 217540 61749 63209404
Gastrooesophageal reflux disease 27.03 9.48 470 217399 95169 63175984
Cardiac disorder 27 9.48 280 217589 50536 63220617
Cestode infection 26.84 9.48 15 217854 272 63270881
Unresponsive to stimuli 26.59 9.48 203 217666 33613 63237540
Cytomegalovirus infection 26.32 9.48 20 217849 20932 63250221
C-reactive protein increased 26.03 9.48 204 217665 94503 63176650
Brain injury 25.49 9.48 67 217802 6976 63264177
Swollen tongue 25.21 9.48 205 217664 34595 63236558
Blood creatinine increased 25.19 9.48 187 217682 87657 63183496
Neck pain 25.04 9.48 355 217514 68963 63202190
Feeling abnormal 24.80 9.48 676 217193 147716 63123437
Drooling 24.45 9.48 46 217823 3822 63267331
Caesarean section 24.45 9.48 14 217855 17018 63254135
Substance abuse 24.20 9.48 52 217817 4755 63266398
Death 24.16 9.48 1541 216328 372840 62898313
Hyperreflexia 24.13 9.48 59 217810 5875 63265278
Transplant rejection 24.10 9.48 4 217865 10776 63260377
Eagle Barrett syndrome 23.93 9.48 6 217863 6 63271147
Abdominal pain upper 23.92 9.48 900 216969 205544 63065609
Restlessness 23.83 9.48 178 217691 29275 63241878
Bone lesion 23.42 9.48 58 217811 5823 63265330
Disease progression 23.40 9.48 289 217580 122469 63148684
Accidental overdose 23.07 9.48 148 217721 23161 63247992
General physical health deterioration 22.97 9.48 521 217348 200881 63070272
Neutropenia 22.81 9.48 443 217426 174562 63096591
Hepatic function abnormal 22.26 9.48 60 217809 37082 63234071
Listless 21.92 9.48 37 217832 2823 63268330
Tinnitus 21.70 9.48 202 217667 35426 63235727
Blood calcium decreased 21.48 9.48 36 217833 26415 63244738
Congenital central hypoventilation syndrome 21.38 9.48 7 217862 29 63271124
Pulmonary fibrosis 21.18 9.48 68 217801 39741 63231412
Disease recurrence 21.10 9.48 40 217829 27990 63243163
Hip arthroplasty 21 9.48 88 217781 47558 63223595
Pregnancy 20.97 9.48 61 217808 36775 63234378
Hypertonia neonatal 20.79 9.48 12 217857 232 63270921
Product use in unapproved indication 20.78 9.48 462 217407 178618 63092535
Menstrual disorder 20.73 9.48 52 217817 5261 63265892
Perineal fistula 20.66 9.48 7 217862 33 63271120
Deep vein thrombosis 20.60 9.48 403 217466 83397 63187756
Muscle tone disorder 20.57 9.48 10 217859 134 63271019
Epilepsy 20.46 9.48 161 217708 26904 63244249
Inappropriate antidiuretic hormone secretion 20.42 9.48 106 217763 15356 63255797
Hyperlipasaemia 20.37 9.48 18 217851 695 63270458
Sedation complication 20.36 9.48 11 217858 13811 63257342
Liver injury 20.27 9.48 123 217746 60397 63210756
Obstructive airways disorder 19.93 9.48 25 217844 20674 63250479
Accidental exposure to product 19.86 9.48 40 217829 27365 63243788
Heart rate decreased 19.56 9.48 85 217784 45475 63225678
Snoring 19.51 9.48 44 217825 4158 63266995
Parosmia 19.44 9.48 56 217813 6150 63265003
Blood parathyroid hormone decreased 19.08 9.48 5 217864 9786 63261367
Hypothyroidism 19.04 9.48 227 217642 42405 63228748
Persistent genital arousal disorder 19.03 9.48 12 217857 274 63270879
Pneumocystis jirovecii pneumonia 18.97 9.48 18 217851 16896 63254257
Gallbladder polyp 18.85 9.48 18 217851 769 63270384
Congenital hypoplasia of depressor angularis oris muscle 18.71 9.48 4 217865 0 63271153
Wrong technique in product usage process 18.70 9.48 131 217738 62209 63208944
Arthralgia 18.56 9.48 1693 216176 568017 62703136
Nephropathy toxic 18.17 9.48 5 217864 9474 63261679
Road traffic accident 18.13 9.48 199 217670 36433 63234720
Premature delivery 18.09 9.48 49 217820 30232 63240921
Livedo reticularis 18.03 9.48 31 217838 2401 63268752
Bladder prolapse 18.01 9.48 29 217840 2127 63269026
Respiratory disorder 17.97 9.48 71 217798 39011 63232142
Hypersensitivity vasculitis 17.92 9.48 42 217827 4070 63267083
Intervertebral disc protrusion 17.90 9.48 141 217728 23568 63247585
Hepatotoxicity 17.86 9.48 66 217803 36975 63234178
Weight increased 17.76 9.48 723 217146 260069 63011084
Interstitial lung disease 17.64 9.48 132 217737 61776 63209377
Paralysis 17.59 9.48 74 217795 9826 63261327
Enthesopathy 17.56 9.48 4 217865 8610 63262543
Metastases to liver 17.56 9.48 34 217835 23605 63247548
Thermal burn 17.46 9.48 53 217816 5993 63265160
Cholangiocarcinoma 17.42 9.48 21 217848 1173 63269980
Inadequate analgesia 17.37 9.48 34 217835 2909 63268244
Neuralgia 17.33 9.48 150 217719 25776 63245377
Allergy test negative 17.29 9.48 10 217859 194 63270959
Cardiogenic shock 17.22 9.48 113 217756 17819 63253334
Decreased appetite 17.22 9.48 1039 216830 250013 63021140
Eating disorder 17.16 9.48 118 217751 18898 63252255
Breast disorder 17.14 9.48 31 217838 2499 63268654
Fear of disease 17.12 9.48 22 217847 1312 63269841
Faecaloma 17.05 9.48 63 217806 7878 63263275
Bone marrow failure 17.04 9.48 48 217821 29242 63241911
Performance enhancing product use 17.03 9.48 5 217864 13 63271140
Type 2 diabetes mellitus 16.89 9.48 139 217730 63729 63207424
Ventricular hypokinesia 16.62 9.48 44 217825 4600 63266553
Haematoma muscle 16.59 9.48 20 217849 1117 63270036
Behaviour disorder 16.56 9.48 35 217834 3164 63267989
Oral discomfort 16.52 9.48 69 217800 9132 63262021
Diabetes mellitus inadequate control 16.19 9.48 98 217771 15028 63256125
Lip pruritus 16.06 9.48 18 217851 929 63270224
Thymus disorder 16.05 9.48 11 217858 290 63270863
Anoxia 15.95 9.48 10 217859 226 63270927
Secondary adrenocortical insufficiency 15.94 9.48 22 217847 1406 63269747
Mood swings 15.74 9.48 112 217757 18136 63253017
Multiple organ dysfunction syndrome 15.70 9.48 122 217747 56630 63214523
Rectal prolapse 15.66 9.48 26 217843 1957 63269196
Umbilical hernia 15.63 9.48 33 217836 2981 63268172
Feeling drunk 15.60 9.48 40 217829 4102 63267051
Vaccination site reaction 15.60 9.48 8 217861 121 63271032
Back injury 15.48 9.48 70 217799 9590 63261563
Labelled drug-drug interaction issue 15.47 9.48 19 217850 1082 63270071
Panniculitis 15.44 9.48 10 217859 11375 63259778
Fear of injection 15.28 9.48 3 217866 7161 63263992
Device ineffective 15.27 9.48 10 217859 244 63270909
Hypoacusis 15.25 9.48 138 217731 24013 63247140
Gastritis 15.10 9.48 195 217674 37108 63234045
Apnoea 15.07 9.48 61 217808 7961 63263192
Magnesium deficiency 15.06 9.48 14 217855 578 63270575
Septic shock 15.01 9.48 151 217718 66478 63204675
Hypoaesthesia oral 14.96 9.48 86 217783 12947 63258206
Deformity 14.87 9.48 11 217858 11673 63259480
Thrombocytopenia 14.79 9.48 400 217469 150757 63120396
Therapy non-responder 14.72 9.48 178 217691 75723 63195430
Diastolic hypotension 14.65 9.48 7 217862 90 63271063
Maternal exposure before pregnancy 14.59 9.48 4 217865 7599 63263554
Foaming at mouth 14.58 9.48 19 217850 1149 63270004
Premenstrual syndrome 14.54 9.48 15 217854 704 63270449
COVID-19 14.52 9.48 287 217582 112816 63158337
Platelet count decreased 14.51 9.48 296 217573 115826 63155327
Haemoglobin decreased 14.49 9.48 384 217485 145101 63126052
Erythema 14.49 9.48 476 217393 175275 63095878
Condition aggravated 14.45 9.48 1186 216683 401031 62870122
Accidental death 14.40 9.48 25 217844 1951 63269202
Vasoplegia syndrome 14.40 9.48 23 217846 1676 63269477
Foetal malnutrition 14.39 9.48 7 217862 94 63271059
Congenital diaphragmatic eventration 14.35 9.48 4 217865 8 63271145
Cholangiectasis acquired 14.35 9.48 4 217865 8 63271145
Wrong rate 14.34 9.48 6 217863 55 63271098
Breast cancer stage II 14.33 9.48 6 217863 8730 63262423
Purple glove syndrome 14.33 9.48 9 217860 204 63270949
Chemical submission 14.32 9.48 10 217859 272 63270881
Prothrombin time shortened 14.23 9.48 25 217844 1970 63269183
Growth disorder 14.20 9.48 5 217864 27 63271126
Sinusitis 14.04 9.48 635 217234 226018 63045135
Cleft uvula 14.03 9.48 4 217865 9 63271144
Antibiotic therapy 13.98 9.48 18 217851 1075 63270078
Polymenorrhoea 13.91 9.48 19 217850 1202 63269951
Amnesia 13.89 9.48 268 217601 55317 63215836
Abdominal wound dehiscence 13.88 9.48 9 217860 216 63270937
Adjustment disorder with depressed mood 13.79 9.48 9 217860 10195 63260958
Lichen sclerosus 13.78 9.48 18 217851 1091 63270062
Victim of child abuse 13.74 9.48 4 217865 10 63271143
Pneumonia viral 13.72 9.48 5 217864 7917 63263236
Hypertonia 13.72 9.48 41 217828 4596 63266557
Vasculitis 13.69 9.48 26 217843 18183 63252970
Alkalosis hypochloraemic 13.66 9.48 8 217861 159 63270994
Renal impairment 13.63 9.48 217 217652 88138 63183015
Blood pressure increased 13.58 9.48 438 217431 161624 63109529
Narcolepsy 13.57 9.48 20 217849 1358 63269795
Insomnia 13.49 9.48 884 216985 214368 63056785
Electrocardiogram QT interval 13.49 9.48 8 217861 163 63270990
Vertebrobasilar insufficiency 13.49 9.48 8 217861 163 63270990
Altered state of consciousness 13.39 9.48 139 217730 25091 63246062
Haemodialysis 13.36 9.48 7 217862 8940 63262213
Hepatitis 13.28 9.48 201 217668 39587 63231566
Emotional disorder 13.27 9.48 85 217784 13294 63257859
Pulmonary toxicity 13.25 9.48 8 217861 9447 63261706
Product label confusion 13.21 9.48 23 217846 1799 63269354
Mixed liver injury 13.20 9.48 41 217828 4694 63266459
Frequent bowel movements 13.19 9.48 38 217831 22984 63248169
Incorrect route of product administration 13.18 9.48 49 217820 27403 63243750
Gallbladder cholesterolosis 13.13 9.48 15 217854 791 63270362
Injection site reaction 13.03 9.48 133 217736 58391 63212762
Eosinophil count increased 13.01 9.48 11 217858 10917 63260236
Surgery 13.00 9.48 184 217685 35728 63235425
Pathogen resistance 12.99 9.48 3 217866 6395 63264758
Gait inability 12.78 9.48 254 217615 52705 63218448
Complication of device insertion 12.72 9.48 5 217864 7559 63263594
Spinal operation 12.56 9.48 59 217810 8212 63262941
Initial insomnia 12.52 9.48 48 217821 6109 63265044
Tuberculosis 12.49 9.48 12 217857 11199 63259954
Prothrombin level increased 12.48 9.48 9 217860 258 63270895
Lymphomatoid papulosis 12.47 9.48 7 217862 128 63271025
Bradycardia foetal 12.44 9.48 11 217858 425 63270728
Hypercapnic coma 12.37 9.48 8 217861 191 63270962
Psychomotor skills impaired 12.37 9.48 26 217843 2342 63268811
Hypertension 12.35 9.48 1116 216753 278187 62992966
Vascular encephalopathy 12.33 9.48 11 217858 430 63270723
Ulcer 12.27 9.48 47 217822 26060 63245093
Bradyphrenia 12.26 9.48 52 217817 6928 63264225
Tachycardia 12.24 9.48 509 217360 117647 63153506
Central nervous system stimulation 12.23 9.48 5 217864 43 63271110
Dementia 12.18 9.48 108 217761 18686 63252467
Nodular rash 12.15 9.48 8 217861 197 63270956
Stillbirth 12.14 9.48 4 217865 6746 63264407
Withdrawal catatonia 12.11 9.48 6 217863 84 63271069
Substance use disorder 12.08 9.48 8 217861 199 63270954
Rhabdomyolysis 12.06 9.48 215 217654 43736 63227417
Therapeutic response decreased 12.04 9.48 144 217725 61381 63209772
Carotid pulse abnormal 11.97 9.48 3 217866 3 63271150
Candida endophthalmitis 11.94 9.48 5 217864 46 63271107
Tenosynovitis 11.94 9.48 18 217851 13777 63257376
Pre-existing condition improved 11.93 9.48 58 217811 8186 63262967
Fatigue 11.88 9.48 2784 215085 885244 62385909
Mood altered 11.87 9.48 89 217780 14654 63256499
Retinal toxicity 11.84 9.48 18 217851 1257 63269896
Dermo-hypodermitis 11.81 9.48 9 217860 281 63270872
Oral lichenoid reaction 11.80 9.48 6 217863 89 63271064
Carbohydrate antigen 15-3 11.80 9.48 6 217863 89 63271064
Normal newborn 11.77 9.48 7 217862 8334 63262819
Electric shock sensation 11.72 9.48 14 217855 774 63270379
Increased tendency to bruise 11.70 9.48 69 217800 10483 63260670
Neuromyopathy 11.68 9.48 13 217856 666 63270487
Carcinoembryonic antigen 11.63 9.48 6 217863 92 63271061
Urinary tract infection 11.61 9.48 1057 216812 263627 63007526
Transcription medication error 11.57 9.48 8 217861 214 63270939
Neuroglycopenia 11.57 9.48 11 217858 467 63270686
Basal cell carcinoma 11.54 9.48 53 217816 27938 63243215
Foreign body 11.44 9.48 25 217844 2313 63268840
Vitamin D decreased 11.38 9.48 67 217802 10175 63260978
Hypoventilation 11.31 9.48 39 217830 4715 63266438
Fat tissue decreased 11.30 9.48 4 217865 22 63271131
Bruxism 11.23 9.48 32 217837 3493 63267660
Dysphoria 11.17 9.48 40 217829 4926 63266227
Back pain 11.16 9.48 1052 216817 263093 63008060
Moebius II syndrome 11.15 9.48 4 217865 23 63271130
Abdominal pain lower 11.15 9.48 136 217733 25542 63245611
Hypotonia 11.14 9.48 62 217807 9223 63261930
Post cardiac arrest syndrome 11.01 9.48 4 217865 24 63271129
Intestinal diaphragm disease 10.97 9.48 6 217863 104 63271049
Dry mouth 10.90 9.48 347 217522 77516 63193637
Multiple injuries 10.89 9.48 21 217848 1777 63269376
Live birth 10.89 9.48 48 217821 25582 63245571
Drug dependence, antepartum 10.87 9.48 4 217865 25 63271128
Myelodysplastic syndrome 10.86 9.48 26 217843 16728 63254425
Foetal death 10.85 9.48 13 217856 10967 63260186
Porphyria 10.83 9.48 7 217862 167 63270986
Lung neoplasm malignant 10.82 9.48 33 217836 19600 63251553
Depressed mood 10.81 9.48 196 217673 39995 63231158
Cytomegalovirus viraemia 10.79 9.48 3 217866 5646 63265507
Bladder dilatation 10.79 9.48 14 217855 843 63270310
Haemodynamic instability 10.78 9.48 61 217808 9129 63262024
Body temperature increased 10.74 9.48 79 217790 37113 63234040
Asthma 10.72 9.48 538 217331 127023 63144130
Gait disturbance 10.72 9.48 748 217121 182430 63088723
Acquired cystic kidney disease 10.70 9.48 5 217864 61 63271092
Lymphopenia 10.69 9.48 30 217839 18297 63252856
Musculoskeletal stiffness 10.68 9.48 521 217348 184097 63087056
Substance use 10.67 9.48 11 217858 516 63270637
Neutrophil count decreased 10.66 9.48 133 217736 56273 63214880
Neonatal hypoxia 10.65 9.48 12 217857 623 63270530
Nystagmus 10.65 9.48 4 217865 6216 63264937
Retinitis 10.58 9.48 4 217865 6192 63264961
Life support 10.58 9.48 8 217861 247 63270906
Haemolysis 10.55 9.48 5 217864 6763 63264390
No adverse event 10.55 9.48 91 217778 41314 63229839
Cystitis noninfective 10.52 9.48 15 217854 988 63270165
Breast cancer female 10.51 9.48 19 217850 13540 63257613
Somnolence neonatal 10.49 9.48 6 217863 114 63271039
Peptic ulcer 10.36 9.48 37 217832 4550 63266603
Tuberculin test positive 10.35 9.48 31 217838 3480 63267673
Haematemesis 10.29 9.48 154 217715 30258 63240895
Hypokalaemia 10.26 9.48 445 217424 103359 63167794
Appetite disorder 10.24 9.48 51 217818 7270 63263883
Gastrointestinal toxicity 10.23 9.48 7 217862 7734 63263419
Peritoneal perforation 10.21 9.48 6 217863 120 63271033
Benzodiazepine drug level increased 10.20 9.48 7 217862 185 63270968
Thinking abnormal 10.18 9.48 67 217802 10576 63260577
Abdominal tenderness 10.11 9.48 55 217814 8111 63263042
Rectal spasm 10.09 9.48 5 217864 70 63271083
Haemophagocytic lymphohistiocytosis 10.06 9.48 13 217856 10614 63260539
Hepatic enzyme abnormal 10.00 9.48 46 217823 6346 63264807
Hot flush 9.99 9.48 238 217631 50921 63220232
Hypercapnia 9.96 9.48 41 217828 5390 63265763
Knee operation 9.95 9.48 44 217825 5969 63265184
Poverty 9.91 9.48 3 217866 9 63271144
Drug withdrawal syndrome neonatal 9.90 9.48 22 217847 2059 63269094
Tearfulness 9.88 9.48 34 217835 4105 63267048
Euphoric mood 9.86 9.48 38 217831 4849 63266304
Congenital multiplex arthrogryposis 9.82 9.48 4 217865 34 63271119
Back disorder 9.73 9.48 68 217801 10949 63260204
Potentiating drug interaction 9.73 9.48 35 217834 4321 63266832
Epstein-Barr virus infection 9.71 9.48 8 217861 8042 63263111
Enostosis 9.67 9.48 3 217866 10 63271143
VIIIth nerve injury 9.67 9.48 3 217866 10 63271143
Blood pressure systolic increased 9.63 9.48 110 217759 47287 63223866
Respiratory depth decreased 9.63 9.48 4 217865 36 63271117
Pneumonia 9.57 9.48 1398 216471 455369 62815784
Injection site erythema 9.52 9.48 215 217654 82959 63188194
Trigger finger 9.49 9.48 35 217834 4373 63266780
Facial paresis 9.48 9.48 30 217839 3468 63267685

FDA Adverse Event Reporting System (Male)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Drug dependence 982.86 10.44 704 101968 23513 34830746
Drug abuse 953.71 10.44 1308 101364 97788 34756471
Toxicity to various agents 503.65 10.44 1508 101164 198854 34655405
Poisoning deliberate 442.69 10.44 280 102392 7564 34846695
Overdose 418.35 10.44 864 101808 90195 34764064
Prescription form tampering 418.27 10.44 120 102552 346 34853913
Serotonin syndrome 354.68 10.44 361 102311 19572 34834687
Intentional overdose 329.85 10.44 515 102157 43159 34811100
Intentional product misuse 321.31 10.44 521 102151 45090 34809169
Drug use disorder 318 10.44 181 102491 4010 34850249
Coma 313.96 10.44 516 102156 45162 34809097
Withdrawal syndrome 257.71 10.44 245 102427 12210 34842049
Miosis 231.24 10.44 205 102467 9330 34844929
Bradypnoea 167.17 10.44 104 102568 2725 34851534
Respiratory depression 137.33 10.44 202 102470 16043 34838216
Somnolence 128.89 10.44 656 102016 110460 34743799
Seizure 127.94 10.44 628 102044 104229 34750030
Asphyxia 112.90 10.44 119 102553 6716 34847543
Confusional state 112.70 10.44 767 101905 143393 34710866
Suicide attempt 111.79 10.44 309 102363 38807 34815452
Drug abuser 110.05 10.44 92 102580 3862 34850397
Off label use 108.98 10.44 754 101918 418770 34435489
Drug dispensed to wrong patient 108.45 10.44 45 102627 479 34853780
Generalised tonic-clonic seizure 100.63 10.44 204 102468 20970 34833289
Prescription drug used without a prescription 95.11 10.44 66 102606 2088 34852171
Poisoning 94.75 10.44 146 102526 12080 34842179
Completed suicide 87.47 10.44 540 102132 97628 34756631
Wrong patient received product 82.80 10.44 66 102606 2588 34851671
Drug withdrawal syndrome 81.39 10.44 180 102492 19654 34834605
Mydriasis 76.14 10.44 100 102572 7137 34847122
Antimicrobial susceptibility test resistant 67.03 10.44 29 102643 345 34853914
Minimum inhibitory concentration 64.06 10.44 23 102649 159 34854100
Hypoglycaemia 62.14 10.44 321 102351 54319 34799940
Depressed level of consciousness 59.05 10.44 266 102406 42575 34811684
Loss of consciousness 58.16 10.44 429 102243 82238 34772021
Hepatocellular injury 58.11 10.44 170 102502 22041 34832218
Housebound 58.05 10.44 23 102649 215 34854044
Inadequate analgesia 56.78 10.44 56 102616 2919 34851340
Dependence 54.95 10.44 37 102635 1113 34853146
Drug resistance 54.93 10.44 6 102666 25921 34828338
Disorientation 50.26 10.44 212 102460 32976 34821283
Disease progression 50.03 10.44 157 102515 107920 34746339
Therapeutic response delayed 49.60 10.44 28 102644 610 34853649
Analgesic drug level above therapeutic 48.78 10.44 22 102650 291 34853968
Antidepressant drug level above therapeutic 47.14 10.44 20 102652 226 34854033
Cholestasis 45.46 10.44 178 102494 26770 34827489
Myoclonus 44.72 10.44 119 102553 14606 34839653
Febrile neutropenia 42.03 10.44 233 102439 136616 34717643
Constipation 41.12 10.44 597 102075 136385 34717874
Pyrexia 39.09 10.44 716 101956 332297 34521962
Accidental overdose 38.94 10.44 139 102533 20001 34834258
Epilepsy 37.90 10.44 144 102528 21351 34832908
Drug ineffective 36.95 10.44 1041 101631 455710 34398549
Drug hypersensitivity 36.79 10.44 380 102292 80149 34774110
Hallucination 36.05 10.44 267 102405 51231 34803028
Agitation 35.96 10.44 290 102382 57109 34797150
Drug tolerance 35.36 10.44 43 102629 2839 34851420
Drug interaction 35.10 10.44 890 101782 225056 34629203
Product use in unapproved indication 35.02 10.44 202 102470 117297 34736962
Analgesic drug level increased 34.94 10.44 25 102647 831 34853428
Expired product administered 34.89 10.44 46 102626 3295 34850964
Cough 34.85 10.44 278 102394 149862 34704397
White blood cell count decreased 34.76 10.44 153 102519 95292 34758967
Joint dislocation 34.65 10.44 48 102624 3605 34850654
Myocardial fibrosis 33.62 10.44 28 102644 1169 34853090
Altered state of consciousness 32.93 10.44 144 102528 22749 34831510
Anterograde amnesia 32.63 10.44 14 102658 163 34854096
Apnoea 32.60 10.44 65 102607 6599 34847660
Adrenergic syndrome 32.58 10.44 12 102660 90 34854169
Narcotic bowel syndrome 32.04 10.44 13 102659 130 34854129
Alanine aminotransferase increased 31.63 10.44 126 102546 80689 34773570
Hyperhidrosis 30.78 10.44 349 102323 75343 34778916
Platelet count decreased 29.97 10.44 217 102455 119500 34734759
Parasomnia 29.44 10.44 17 102655 387 34853872
Treatment failure 29.27 10.44 58 102614 46639 34807620
Haemoglobin decreased 28.77 10.44 222 102450 120550 34733709
Oedematous pancreatitis 28.68 10.44 18 102654 479 34853780
Pneumonia aspiration 28.62 10.44 216 102456 41687 34812572
Vomiting 28.16 10.44 938 101734 246683 34607576
Hyperacusis 27.70 10.44 22 102650 858 34853401
Hallucination, visual 27.20 10.44 114 102558 17677 34836582
Anal haemorrhage 26.16 10.44 35 102637 2543 34851716
Negative pressure pulmonary oedema 25.96 10.44 13 102659 220 34854039
Symmetrical drug-related intertriginous and flexural exanthema 25.96 10.44 15 102657 342 34853917
Mucosal inflammation 25.94 10.44 46 102626 38576 34815683
Drug diversion 25.60 10.44 21 102651 858 34853401
Respiratory acidosis 25.60 10.44 50 102622 5000 34849259
Arteriovenous fistula 25.18 10.44 23 102649 1088 34853171
Mixed anxiety and depressive disorder 24.74 10.44 10 102662 99 34854160
Foetal disorder 24.62 10.44 20 102652 806 34853453
Myelosuppression 24.47 10.44 13 102659 19252 34835007
Urinary retention 24.18 10.44 186 102486 36102 34818157
Behaviour disorder 24.15 10.44 48 102624 4862 34849397
Tonic convulsion 23.65 10.44 23 102649 1178 34853081
Euphoric mood 22.92 10.44 51 102621 5590 34848669
Cytomegalovirus infection 22.63 10.44 26 102646 26109 34828150
Wrong product administered 22.55 10.44 49 102623 5285 34848974
Product dispensing error 22.49 10.44 54 102618 6220 34848039
Hyperaesthesia 22.45 10.44 45 102627 4585 34849674
Drug screen positive 22.42 10.44 41 102631 3902 34850357
Neutrophil count decreased 22.40 10.44 76 102596 51028 34803231
Hyper IgE syndrome 22.32 10.44 8 102664 55 34854204
Hallucinations, mixed 22.09 10.44 33 102639 2656 34851603
Appendicitis 21.95 10.44 8 102664 14799 34839460
Sepsis 21.77 10.44 351 102321 166210 34688049
Accidental exposure to product by child 21.41 10.44 24 102648 1452 34852807
Puncture site haematoma 21.23 10.44 10 102662 147 34854112
Suicidal behaviour 21.13 10.44 24 102648 1473 34852786
Graft versus host disease 21.04 10.44 3 102669 10566 34843693
Body mass index abnormal 20.87 10.44 10 102662 153 34854106
Road traffic accident 20.86 10.44 104 102568 17346 34836913
Neutropenia neonatal 20.72 10.44 17 102655 695 34853564
Pulmonary oedema 20.62 10.44 222 102450 47307 34806952
Pneumonia 20.29 10.44 865 101807 361762 34492497
Palmoplantar pustulosis 20.16 10.44 9 102663 116 34854143
Drug withdrawal syndrome neonatal 19.78 10.44 37 102635 3582 34850677
Hypoosmolar state 19.69 10.44 9 102663 123 34854136
Dyspnoea 19.60 10.44 906 101766 375876 34478383
Vascular malformation 19.54 10.44 8 102664 82 34854177
Physical deconditioning 19.54 10.44 22 102650 1337 34852922
Substance use disorder 19.38 10.44 17 102655 762 34853497
Decompression sickness 19.33 10.44 4 102668 0 34854259
Product administration error 19.25 10.44 97 102575 16247 34838012
Wheezing 19.24 10.44 60 102612 41342 34812917
Insomnia 18.74 10.44 418 102254 103489 34750770
Hypopnoea 18.67 10.44 28 102644 2261 34851998
Multiple organ dysfunction syndrome 18.57 10.44 140 102532 76426 34777833
Drug detoxification 18.53 10.44 11 102661 264 34853995
Post stroke epilepsy 18.38 10.44 5 102667 11 34854248
Discoloured vomit 18.36 10.44 14 102658 514 34853745
Sleep disorder 18.18 10.44 157 102515 31531 34822728
Urethral valves 18.14 10.44 11 102661 275 34853984
Inappropriate schedule of product administration 18.06 10.44 108 102564 62188 34792071
Bladder cancer 17.89 10.44 13 102659 16265 34837994
Inflammation 17.85 10.44 35 102637 28260 34825999
Oesophageal carcinoma 17.70 10.44 3 102669 9301 34844958
Neuroleptic malignant syndrome 17.62 10.44 16 102656 17918 34836341
Logorrhoea 17.45 10.44 28 102644 2398 34851861
Acidosis 17.41 10.44 71 102601 10874 34843385
Spinal operation 17.23 10.44 31 102641 2913 34851346
Substance abuser 17.21 10.44 8 102664 114 34854145
Fall 17.15 10.44 744 101928 202141 34652118
Polyneuropathy in malignant disease 17.04 10.44 10 102662 235 34854024
Change of bowel habit 16.94 10.44 18 102654 1025 34853234
Aspartate aminotransferase increased 16.88 10.44 123 102549 67660 34786599
Faecaloma 16.88 10.44 44 102628 5333 34848926
Aplastic anaemia 16.68 10.44 4 102668 9712 34844547
Nightmare 16.66 10.44 85 102587 14306 34839953
Product substitution 16.65 10.44 6 102666 42 34854217
Product storage error 16.51 10.44 57 102615 8065 34846194
Acute cutaneous lupus erythematosus 16.51 10.44 7 102665 79 34854180
Intentional self-injury 16.41 10.44 82 102590 13689 34840570
Hepatic function abnormal 16.21 10.44 71 102601 44292 34809967
Visceral congestion 16.18 10.44 14 102658 616 34853643
Bone marrow failure 16.13 10.44 39 102633 29214 34825045
Faecal disimpaction 15.99 10.44 5 102667 21 34854238
Renal impairment 15.98 10.44 189 102483 94324 34759935
Disease recurrence 15.92 10.44 24 102648 21466 34832793
Nausea 15.60 10.44 1179 101493 338729 34515530
Suicidal ideation 15.42 10.44 184 102488 40204 34814055
Ligament calcification 15.35 10.44 9 102663 211 34854048
Gastric bypass 15.27 10.44 10 102662 287 34853972
Leukopenia 15.20 10.44 115 102557 62741 34791518
Condition aggravated 15.19 10.44 439 102233 191757 34662502
Stoma site pain 15.19 10.44 14 102658 670 34853589
Haemorrhagic fever 14.96 10.44 5 102667 27 34854232
Oesophagitis chemical 14.88 10.44 6 102666 59 34854200
Tooth injury 14.82 10.44 18 102654 1187 34853072
Wrong technique in product usage process 14.78 10.44 55 102617 35931 34818328
Death 14.67 10.44 1358 101314 396691 34457568
Full blood count abnormal 14.67 10.44 20 102652 18648 34835611
Cardiac failure congestive 14.67 10.44 165 102507 83105 34771154
Aggression 14.65 10.44 177 102495 38787 34815472
Therapy partial responder 14.59 10.44 5 102667 9611 34844648
Transplant rejection 14.57 10.44 6 102666 10305 34843954
Femoral artery aneurysm 14.56 10.44 8 102664 165 34854094
Inappropriate antidiuretic hormone secretion 14.54 10.44 75 102597 12678 34841581
Aspergillus infection 14.52 10.44 9 102663 12245 34842014
Hanging 14.52 10.44 8 102664 166 34854093
Injection site pain 14.51 10.44 62 102610 38943 34815316
Epilepsy with myoclonic-atonic seizures 14.50 10.44 3 102669 0 34854259
Lumbar radiculopathy 14.48 10.44 15 102657 829 34853430
Hepatic cytolysis 14.33 10.44 82 102590 14414 34839845
Drug reaction with eosinophilia and systemic symptoms 14.23 10.44 154 102518 32858 34821401
Hyperinsulinaemia 14.20 10.44 6 102666 67 34854192
Influenza virus test positive 14.16 10.44 7 102665 115 34854144
Dehydration 14.09 10.44 283 102389 129686 34724573
Schizophrenia 14.05 10.44 4 102668 8662 34845597
Perineal infection 14.04 10.44 13 102659 626 34853633
Ventricular fibrillation 13.96 10.44 29 102643 22925 34831334
Theft 13.90 10.44 9 102663 253 34854006
Ascites 13.89 10.44 80 102592 46491 34807768
Somnambulism 13.88 10.44 29 102643 3043 34851216
Quality of life decreased 13.88 10.44 34 102638 3967 34850292
Scrotal infection 13.80 10.44 13 102659 640 34853619
White blood cell count increased 13.77 10.44 68 102604 41083 34813176
Anxiety 13.76 10.44 386 102286 99042 34755217
Lymphoma 13.73 10.44 10 102662 12497 34841762
Chemical poisoning 13.69 10.44 7 102665 124 34854135
Anaemia 13.56 10.44 554 102118 232781 34621478
Reversible cerebral vasoconstriction syndrome 13.48 10.44 11 102661 446 34853813
Blood creatinine increased 13.46 10.44 197 102475 94779 34759480
Haemophagocytic lymphohistiocytosis 13.44 10.44 11 102661 12962 34841297
Haematocrit decreased 13.39 10.44 49 102623 32167 34822092
Osteoarthritis 13.30 10.44 105 102567 20537 34833722
Dyspnoea exertional 13.09 10.44 74 102598 43205 34811054
Myocardial infarction 13.02 10.44 264 102408 120821 34733438
Eosinophilic pneumonia chronic 12.93 10.44 9 102663 286 34853973
Major depression 12.93 10.44 36 102636 4536 34849723
Allodynia 12.90 10.44 14 102658 817 34853442
Abnormal sleep-related event 12.87 10.44 11 102661 476 34853783
Increased appetite 12.87 10.44 3 102669 7426 34846833
Optic nerve operation 12.81 10.44 11 102661 479 34853780
Pleural mesothelioma 12.81 10.44 6 102666 87 34854172
Respiratory rate decreased 12.75 10.44 24 102648 2335 34851924
Back pain 12.71 10.44 457 102215 121332 34732927
Dermal cyst 12.68 10.44 21 102651 1846 34852413
Blood glucose increased 12.63 10.44 130 102542 66588 34787671
Immune reconstitution inflammatory syndrome 12.54 10.44 5 102667 8754 34845505
Capillary fragility 12.50 10.44 5 102667 48 34854211
Rash 12.49 10.44 531 102141 222221 34632038
Therapeutic product effect decreased 12.45 10.44 56 102616 34687 34819572
Central-alveolar hypoventilation 12.43 10.44 3 102669 3 34854256
Victim of sexual abuse 12.43 10.44 3 102669 3 34854256
Hydroxyprolinuria 12.43 10.44 3 102669 3 34854256
Spleen congestion 12.40 10.44 9 102663 306 34853953
Eosinophilic fasciitis 12.40 10.44 6 102666 94 34854165
Torsade de pointes 12.31 10.44 3 102669 7206 34847053
Arterial spasm 12.28 10.44 6 102666 96 34854163
Antiphospholipid antibodies positive 12.27 10.44 9 102663 311 34853948
Weaning failure 12.11 10.44 8 102664 233 34854026
Blood urea increased 12.09 10.44 47 102625 30317 34823942
Interstitial lung disease 12.03 10.44 128 102544 65154 34789105
Poor feeding infant 11.94 10.44 11 102661 526 34853733
Haematuria 11.92 10.44 92 102580 49974 34804285
Hyperthermia 11.91 10.44 62 102610 10515 34843744
Cerebral infarction 11.91 10.44 41 102631 27414 34826845
Sweat gland disorder 11.91 10.44 6 102666 103 34854156
Bronchiectasis 11.89 10.44 7 102665 9794 34844465
Bladder dilatation 11.81 10.44 18 102654 1474 34852785
Ichthyosis 11.80 10.44 6 102666 105 34854154
Congenital heart valve disorder 11.75 10.44 5 102667 57 34854202
Intervertebral disc protrusion 11.66 10.44 59 102613 9897 34844362
Blood lactate dehydrogenase increased 11.63 10.44 32 102640 22958 34831301
Social anxiety disorder 11.56 10.44 9 102663 341 34853918
Therapeutic drug monitoring analysis not performed 11.47 10.44 11 102661 554 34853705
Cardio-respiratory arrest 11.46 10.44 227 102445 55046 34799213
Stress 11.43 10.44 48 102624 30299 34823960
Tongue injury 11.41 10.44 6 102666 113 34854146
Hepatic cancer 11.40 10.44 5 102667 8270 34845989
Thrombocytopenia 11.33 10.44 361 102311 155886 34698373
Asthma 11.31 10.44 76 102596 42580 34811679
Visceral pain 11.30 10.44 5 102667 63 34854196
Limb fracture 11.22 10.44 4 102668 27 34854232
Otospondylomegaepiphyseal dysplasia 11.18 10.44 6 102666 118 34854141
Pre-existing condition improved 11.17 10.44 24 102648 2568 34851691
Perineal pain 11.16 10.44 13 102659 820 34853439
Lentigo maligna 11.16 10.44 9 102663 359 34853900
Renal tubular necrosis 11.15 10.44 18 102654 15662 34838597
Ejection fraction decreased 10.99 10.44 25 102647 19129 34835130
Product appearance confusion 10.98 10.44 4 102668 29 34854230
Neuralgia 10.94 10.44 79 102593 15034 34839225
Pseudoporphyria 10.86 10.44 9 102663 373 34853886
Restless legs syndrome 10.86 10.44 51 102621 8303 34845956
Arthrofibrosis 10.83 10.44 5 102667 70 34854189
Oxygen saturation decreased 10.82 10.44 220 102452 53598 34800661
Obstructive airways disorder 10.82 10.44 18 102654 15476 34838783
Haemodialysis 10.81 10.44 9 102663 10517 34843742
Trigger finger 10.64 10.44 13 102659 862 34853397
Product dose omission issue 10.60 10.44 269 102403 119442 34734817
Spinal disorder 10.60 10.44 32 102640 4220 34850039
Impaired reasoning 10.58 10.44 6 102666 132 34854127
Pulmonary congestion 10.57 10.44 73 102599 13692 34840567
Dyschezia 10.55 10.44 17 102655 1461 34852798
Drug withdrawal convulsions 10.47 10.44 15 102657 1162 34853097

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Drug abuse 1198.93 9.51 2060 270324 160631 79311373
Drug dependence 1181.78 9.51 1035 271349 39734 79432270
Serotonin syndrome 1066.82 9.51 1021 271363 44006 79427998
Poisoning deliberate 995.78 9.51 683 271701 18145 79453859
Toxicity to various agents 993.60 9.51 3429 268955 418111 79053893
Coma 631.46 9.51 1189 271195 99460 79372544
Intentional overdose 525.27 9.51 1135 271249 104825 79367179
Overdose 513.97 9.51 1589 270795 182617 79289387
Drug use disorder 431.97 9.51 303 272081 8348 79463656
Withdrawal syndrome 426.42 9.51 492 271892 26362 79445642
Completed suicide 412.63 9.51 1798 270586 243969 79228035
Intentional product misuse 400.00 9.51 955 271429 94210 79377794
Bradypnoea 388.96 9.51 248 272136 5804 79466200
Somnolence 380.48 9.51 1721 270663 237260 79234744
Miosis 373.74 9.51 358 272026 15431 79456573
Respiratory depression 322.77 9.51 434 271950 27196 79444808
Drug withdrawal syndrome 271.58 9.51 452 271932 34266 79437738
Off label use 252.73 9.51 1940 270444 905275 78566729
Mydriasis 233.90 9.51 295 272089 17348 79454656
Suicide attempt 218.68 9.51 702 271682 82230 79389774
Prescription form tampering 216.25 9.51 72 272312 320 79471684
Drug hypersensitivity 206.87 9.51 1735 270649 297181 79174823
Drug interaction 186.64 9.51 2203 270181 412980 79059024
Pemphigus 179.69 9.51 58 272326 99524 79372480
Hepatocellular injury 163.82 9.51 443 271941 47150 79424854
Generalised tonic-clonic seizure 163.64 9.51 421 271963 43489 79428515
Seizure 162.22 9.51 1153 271231 187681 79284323
Confusional state 160.78 9.51 1727 270657 316270 79155734
Sensitisation 158.43 9.51 113 272271 3198 79468806
Asphyxia 157.00 9.51 197 272187 11523 79460481
Treatment failure 155.36 9.51 213 272171 170273 79301731
Polycystic ovaries 147.26 9.51 114 272270 3665 79468339
Hand deformity 142.97 9.51 89 272295 103830 79368174
Synovitis 138.67 9.51 187 272197 150547 79321457
Infusion related reaction 135.51 9.51 373 272011 229864 79242140
Drug abuser 130.44 9.51 130 272254 5883 79466121
Ejection fraction 126.33 9.51 85 272299 2184 79469820
Drug ineffective 125.70 9.51 2777 269607 1078136 78393868
Prescription drug used without a prescription 124.94 9.51 107 272277 3978 79468026
Contraindicated product administered 124.22 9.51 217 272167 157321 79314683
Glossodynia 123.22 9.51 103 272281 103234 79368770
Poisoning 122.00 9.51 268 272116 25004 79447000
Anti-cyclic citrullinated peptide antibody positive 120.31 9.51 67 272317 83076 79388928
Joint swelling 120.01 9.51 542 271842 288104 79183900
Pericarditis 119.32 9.51 108 272276 104128 79367876
Cholestasis 113.57 9.51 414 271970 51695 79420309
Drug detoxification 106.37 9.51 43 272341 360 79471644
Maternal exposure during pregnancy 105.90 9.51 190 272194 136348 79335656
Systemic lupus erythematosus 103.81 9.51 158 272226 120991 79351013
Vomiting 100.03 9.51 2978 269406 662850 78809154
Drug intolerance 95.93 9.51 520 271864 263599 79208405
Fall 94.43 9.51 2255 270129 485374 78986630
Gastrointestinal pain 90.38 9.51 138 272246 9717 79462287
Hallucination, visual 88.01 9.51 279 272105 32450 79439554
Rash 87.24 9.51 1420 270964 576938 78895066
Disorientation 87.23 9.51 435 271949 62341 79409663
Helicobacter infection 86.19 9.51 67 272317 69637 79402367
Therapeutic product effect decreased 85.92 9.51 280 272104 163583 79308421
Hepatic enzyme increased 83.17 9.51 331 272053 182279 79289725
Myoclonus 82.98 9.51 245 272139 27415 79444589
Analgesic drug level increased 82.77 9.51 76 272308 3102 79468902
Deafness transitory 82.50 9.51 48 272336 947 79471057
Wound 81.13 9.51 172 272212 116007 79355997
Drug resistance 80.85 9.51 22 272362 42191 79429813
Derealisation 80.56 9.51 57 272327 1592 79470412
Rheumatoid factor positive 79.90 9.51 53 272331 59786 79412218
Febrile neutropenia 79.41 9.51 463 271921 230536 79241468
Duodenal ulcer perforation 78.92 9.51 66 272318 66145 79405859
Hallucination 78.53 9.51 532 271852 85213 79386791
Hypoglycaemia 78.43 9.51 605 271779 100989 79371015
Loss of consciousness 78.29 9.51 898 271486 167045 79304959
Rhinitis allergic 76.91 9.51 145 272239 12124 79459880
Pyrexia 76.19 9.51 1752 270632 676957 78795047
Discomfort 75.75 9.51 201 272183 125416 79346588
Alopecia 74.66 9.51 473 271911 230882 79241122
Carpal tunnel syndrome 74.58 9.51 189 272195 19339 79452665
Dependence 73.18 9.51 63 272321 2359 79469645
Depressed level of consciousness 72.64 9.51 572 271812 96080 79375924
Wrong patient received product 72.27 9.51 84 272300 4534 79467470
Agitation 69.99 9.51 581 271803 99134 79372870
Respiratory acidosis 69.75 9.51 132 272252 11068 79460936
Hyperacusis 67.52 9.51 58 272326 2165 79469839
Blood test abnormal 67.21 9.51 171 272213 17539 79454465
Myelosuppression 66.68 9.51 27 272357 40269 79431735
Death 66.27 9.51 2461 269923 564053 78907951
Depersonalisation/derealisation disorder 65.74 9.51 53 272331 1809 79470195
Epilepsy 64.65 9.51 294 272090 40566 79431438
Cardio-respiratory arrest 64.17 9.51 609 271775 107901 79364103
Urinary retention 64.11 9.51 371 272013 56259 79415745
Hyperhidrosis 62.70 9.51 792 271592 150700 79321304
Burning sensation 62.44 9.51 378 272006 58254 79413750
Constipation 61.23 9.51 1330 271054 281720 79190284
Minimum inhibitory concentration 60.92 9.51 23 272361 157 79471847
Red blood cell sedimentation rate increased 60.92 9.51 41 272343 45901 79426103
Sleep apnoea syndrome 60.37 9.51 266 272118 36212 79435792
Red blood cell sedimentation rate abnormal 59.10 9.51 3 272381 20960 79451044
Antimicrobial susceptibility test resistant 58.74 9.51 28 272356 360 79471644
Gastric pH decreased 56.17 9.51 36 272348 850 79471154
Inadequate analgesia 56.03 9.51 74 272310 4555 79467449
Disease progression 55.90 9.51 384 272000 183978 79288026
Muscle injury 54.75 9.51 51 272333 48510 79423494
Cytomegalovirus infection 53.98 9.51 40 272344 42604 79429400
Hallucinations, mixed 52.84 9.51 89 272295 6810 79465194
Accidental overdose 52.68 9.51 271 272113 39310 79432694
Hypersensitivity 52.31 9.51 608 271776 261631 79210373
Drug diversion 51.54 9.51 39 272345 1211 79470793
Product use in unapproved indication 51.28 9.51 577 271807 249782 79222222
Apnoea 50.80 9.51 119 272265 11585 79460419
Drug dispensed to wrong patient 50.58 9.51 31 272353 675 79471329
Device expulsion 50.43 9.51 13 272371 25848 79446156
Nausea 50.35 9.51 3856 268528 953340 78518664
Platelet count decreased 49.80 9.51 425 271959 194239 79277765
Clonus 49.44 9.51 86 272298 6754 79465250
C-reactive protein increased 47.92 9.51 252 272132 128775 79343229
Ejection fraction abnormal 47.92 9.51 50 272334 2390 79469614
Suicidal ideation 47.92 9.51 434 271950 75906 79396098
Shoulder arthroplasty 46.91 9.51 57 272327 3225 79468779
Exposure during pregnancy 46.86 9.51 182 272202 100950 79371054
Abdominal discomfort 46.69 9.51 590 271794 250137 79221867
Folliculitis 46.68 9.51 73 272311 55307 79416697
Arthropathy 45.16 9.51 387 271997 176724 79295280
Housebound 44.95 9.51 25 272359 451 79471553
Infection 44.56 9.51 570 271814 241142 79230862
Ankylosing spondylitis 44.41 9.51 116 272268 12089 79459915
Behaviour disorder 43.86 9.51 78 272306 6235 79465769
Depression 43.50 9.51 1008 271376 215782 79256222
Functional gastrointestinal disorder 43.14 9.51 68 272316 4922 79467082
Visceral congestion 42.04 9.51 31 272353 925 79471079
Intentional product use issue 41.69 9.51 326 272058 151786 79320218
Haemoglobin decreased 41.61 9.51 522 271862 221597 79250407
Decorticate posture 40.84 9.51 21 272363 321 79471683
Leukopenia 40.29 9.51 233 272151 116280 79355724
Altered state of consciousness 40.17 9.51 272 272112 43550 79428454
Myocardial depression 39.88 9.51 24 272360 505 79471499
Delirium 39.62 9.51 453 271931 84174 79387830
Multiple organ dysfunction syndrome 39.19 9.51 245 272139 120001 79352003
Nephrectomy 39.16 9.51 42 272342 2073 79469931
Cyanosis 38.95 9.51 180 272204 25002 79447002
Hepatic function abnormal 38.94 9.51 124 272260 72983 79399021
Feeling of despair 38.71 9.51 48 272336 2773 79469231
Impaired healing 38.56 9.51 161 272223 87494 79384510
Tonic clonic movements 38.51 9.51 43 272341 2221 79469783
Sacroiliitis 37.91 9.51 55 272329 3699 79468305
Rheumatoid nodule 37.58 9.51 7 272377 17431 79454573
Vertigo 37.55 9.51 381 272003 68701 79403303
Multiple drug therapy 37.25 9.51 57 272327 4021 79467983
Blood creatinine increased 37.25 9.51 344 272040 154713 79317291
Peripheral circulatory failure 37.07 9.51 31 272353 1115 79470889
Renal impairment 37.06 9.51 352 272032 157431 79314573
Mycotic allergy 37.00 9.51 35 272349 1484 79470520
Sphincter of Oddi dysfunction 36.20 9.51 21 272363 412 79471592
Transplant rejection 35.62 9.51 11 272373 19426 79452578
Disease recurrence 35.44 9.51 60 272324 44049 79427955
Therapeutic response delayed 35.10 9.51 30 272354 1112 79470892
Nightmare 35.07 9.51 178 272206 25683 79446321
Cough 34.79 9.51 970 271414 365819 79106185
Victim of sexual abuse 34.68 9.51 22 272362 510 79471494
COVID-19 34.43 9.51 358 272026 157316 79314688
Pneumonia 34.10 9.51 1876 270508 658370 78813634
Abnormal loss of weight 34.02 9.51 83 272301 8293 79463711
Analgesic drug level above therapeutic 33.83 9.51 21 272363 468 79471536
Neutropenia 33.49 9.51 738 271646 286972 79185032
Faecaloma 33.33 9.51 101 272283 11463 79460541
Anxiety 33.29 9.51 1097 271287 247415 79224589
Eyelid myoclonus 33.11 9.51 13 272371 100 79471904
Euphoric mood 32.93 9.51 78 272306 7648 79464356
Product use issue 32.91 9.51 511 271873 209311 79262693
Pathogen resistance 32.58 9.51 5 272379 14337 79457667
Cryopyrin associated periodic syndrome 32.43 9.51 19 272365 380 79471624
Wrong technique in product usage process 32.30 9.51 136 272248 73739 79398265
Bone marrow failure 32.16 9.51 80 272304 51027 79420977
Respiratory arrest 32.05 9.51 319 272065 57231 79414773
Sleep disorder due to general medical condition, insomnia type 31.65 9.51 63 272321 43493 79428511
Unresponsive to stimuli 31.44 9.51 310 272074 55478 79416526
Somatic symptom disorder 31.39 9.51 41 272343 2496 79469508
Obstructive airways disorder 31.02 9.51 37 272347 31422 79440582
Inappropriate antidiuretic hormone secretion 30.84 9.51 174 272210 26139 79445865
Disturbance in attention 30.46 9.51 286 272098 50515 79421489
Narcotic bowel syndrome 30.03 9.51 16 272368 264 79471740
Hyponatraemia 30.03 9.51 808 271576 177040 79294964
Feeling of body temperature change 29.80 9.51 60 272324 5266 79466738
Pancreatic fibrosis 29.73 9.51 12 272372 100 79471904
Alanine aminotransferase increased 29.71 9.51 384 272000 162186 79309818
Dissociation 29.64 9.51 51 272333 3970 79468034
Thrombotic microangiopathy 29.54 9.51 16 272368 20153 79451851
Speech disorder 29.45 9.51 300 272084 54145 79417859
Psychotic disorder due to a general medical condition 29.45 9.51 16 272368 275 79471729
Creatinine renal clearance decreased 29.44 9.51 14 272370 18988 79453016
Pancreatitis acute 29.11 9.51 278 272106 49326 79422678
Fibromyalgia 29.04 9.51 342 272042 63998 79408006
Feeding disorder 28.79 9.51 121 272263 16133 79455871
Expired product administered 28.77 9.51 70 272314 6981 79465023
Premature delivery 28.45 9.51 23 272361 23444 79448560
White blood cell count decreased 28.37 9.51 462 271922 187826 79284178
Interstitial lung disease 28.26 9.51 247 272137 112353 79359651
Cytomegalovirus viraemia 27.95 9.51 5 272379 12816 79459188
Acute generalised exanthematous pustulosis 27.93 9.51 125 272259 17129 79454875
Gastrooesophageal reflux disease 27.92 9.51 506 271878 103740 79368264
Neutrophil count decreased 27.82 9.51 197 272187 93762 79378242
Restless legs syndrome 27.74 9.51 139 272245 19953 79452051
Eosinophil count increased 27.44 9.51 12 272372 17093 79454911
Cestode infection 27.35 9.51 15 272369 263 79471741
Blood pressure increased 27.28 9.51 533 271851 210827 79261177
H1N1 influenza 27.05 9.51 38 272346 2481 79469523
Hyperlipasaemia 26.99 9.51 27 272357 1227 79470777
Aspergillus infection 26.91 9.51 16 272368 19145 79452859
Epstein-Barr virus infection 26.71 9.51 8 272376 14408 79457596
Chronic kidney disease 26.56 9.51 344 272040 65810 79406194
Parasomnia 26.50 9.51 19 272365 542 79471462
Bladder cancer 26.46 9.51 17 272367 19509 79452495
Encephalopathy 26.45 9.51 349 272035 67048 79404956
Breast disorder 26.32 9.51 34 272350 2047 79469957
Coma scale abnormal 26.15 9.51 77 272307 8601 79463403
Adrenergic syndrome 25.98 9.51 12 272372 143 79471861
Sleep disorder due to a general medical condition 25.85 9.51 107 272277 14170 79457834
Road traffic accident 25.77 9.51 245 272139 43419 79428585
Irritable bowel syndrome 25.74 9.51 117 272267 62124 79409880
Haemophagocytic lymphohistiocytosis 25.73 9.51 22 272362 21815 79450189
Stomatitis 25.59 9.51 350 272034 146407 79325597
Skin necrosis 25.55 9.51 15 272369 18072 79453932
Septic shock 25.52 9.51 282 272102 122519 79349485
Antidepressant drug level above therapeutic 25.49 9.51 20 272364 656 79471348
Accidental exposure to product by child 25.47 9.51 40 272344 2886 79469118
Menstrual disorder 25.41 9.51 48 272336 4019 79467985
Neck pain 24.97 9.51 379 272005 75038 79396966
Pituitary tumour benign 24.94 9.51 37 272347 2539 79469465
Fracture 24.78 9.51 143 272241 21658 79450346
Nephropathy toxic 24.77 9.51 20 272364 20399 79451605
Muscle spasms 24.61 9.51 776 271608 173954 79298050
Drug eruption 24.47 9.51 73 272311 43862 79428142
Victim of chemical submission 24.44 9.51 18 272366 536 79471468
Bradycardia foetal 24.43 9.51 11 272373 123 79471881
Cerebral infarction 23.95 9.51 78 272306 45598 79426406
Prothrombin time shortened 23.87 9.51 41 272343 3187 79468817
Negative pressure pulmonary oedema 23.85 9.51 13 272371 225 79471779
Swelling 23.76 9.51 561 271823 216150 79255854
Acute motor-sensory axonal neuropathy 23.71 9.51 16 272368 413 79471591
Lower respiratory tract infection 23.69 9.51 305 272079 128915 79343089
Therapeutic product ineffective 23.69 9.51 31 272353 1891 79470113
Pneumocystis jirovecii pneumonia 23.64 9.51 47 272337 32461 79439543
Substance use disorder 23.59 9.51 22 272362 916 79471088
Blood parathyroid hormone decreased 23.20 9.51 4 272380 10532 79461472
Tremor 23.07 9.51 752 271632 169331 79302673
Haemodialysis 23.05 9.51 17 272367 18151 79453853
Heart rate decreased 23.05 9.51 143 272241 70173 79401831
Sleep disorder 22.99 9.51 416 271968 85261 79386743
Oesophageal carcinoma 22.74 9.51 5 272379 11079 79460925
Thrombocytopenia 22.52 9.51 712 271672 264547 79207457
Suicidal behaviour 22.40 9.51 40 272344 3207 79468797
Gait disturbance 21.93 9.51 892 271492 206614 79265390
Respiratory disorder 21.90 9.51 79 272305 44777 79427227
Graft versus host disease 21.89 9.51 12 272372 15014 79456990
Intervertebral disc protrusion 21.88 9.51 147 272237 23474 79448530
Arteriovenous fistula 21.81 9.51 25 272359 1329 79470675
Hyperaesthesia 21.66 9.51 91 272293 12131 79459873
Hypertonia 21.63 9.51 64 272320 7168 79464836
Ascites 21.61 9.51 160 272224 75402 79396602
Neuralgia 21.56 9.51 191 272193 33193 79438811
Blood calcium decreased 21.46 9.51 48 272336 31771 79440233
Drug screen positive 21.42 9.51 57 272327 6006 79465998
Congenital central hypoventilation syndrome 21.42 9.51 7 272377 29 79471975
Headache 21.28 9.51 2547 269837 651225 78820779
Pneumonia aspiration 21.20 9.51 334 272050 66633 79405371
Abortion spontaneous 21.17 9.51 43 272341 29464 79442540
Hepatic cytolysis 21.11 9.51 162 272222 26989 79445015
Muscle rigidity 21.05 9.51 128 272256 19754 79452250
Cardiac failure congestive 20.92 9.51 351 272033 142051 79329953
Central nervous system stimulation 20.90 9.51 8 272376 57 79471947
Sedation complication 20.75 9.51 14 272370 15655 79456349
Substance abuse 20.75 9.51 81 272303 10445 79461559
Mucosal inflammation 20.69 9.51 162 272222 75418 79396586
Hyperkalaemia 20.60 9.51 271 272113 114127 79357877
Body mass index abnormal 20.57 9.51 12 272372 238 79471766
Amnesia 20.53 9.51 316 272068 62741 79409263
Haematocrit decreased 20.45 9.51 124 272260 61188 79410816
Frequent bowel movements 20.39 9.51 44 272340 29495 79442509
Myocardial infarction 20.36 9.51 476 271908 183653 79288351
Psychomotor skills impaired 20.32 9.51 51 272333 5186 79466818
Pseudomonas infection 20.17 9.51 25 272359 20878 79451126
Cogwheel rigidity 19.98 9.51 37 272347 3051 79468953
Weight increased 19.97 9.51 760 271624 276626 79195378
Appendicitis 19.93 9.51 25 272359 20769 79451235
Substance abuser 19.92 9.51 10 272374 145 79471859
Listless 19.84 9.51 42 272342 3819 79468185
Allergy test negative 19.77 9.51 13 272371 321 79471683
Dizziness 19.72 9.51 2070 270314 524371 78947633
Colorectal cancer 19.68 9.51 3 272381 8644 79463360
General physical health deterioration 19.62 9.51 755 271629 274483 79197521
Muscle tone disorder 19.56 9.51 10 272374 151 79471853
Mixed anxiety and depressive disorder 19.54 9.51 14 272370 399 79471605
Renal disorder 19.53 9.51 225 272159 41880 79430124
Emotional disorder 19.49 9.51 99 272285 14288 79457716
Tachycardia 19.44 9.51 767 271617 177001 79295003
Persistent genital arousal disorder 19.27 9.51 12 272372 269 79471735
Condition aggravated 19.13 9.51 1463 270921 499661 78972343
Inappropriate schedule of product administration 19.10 9.51 331 272053 133297 79338707
Limb injury 19.10 9.51 169 272215 29359 79442645
Blister 19.05 9.51 290 272094 119186 79352818
Parosmia 19.04 9.51 60 272324 6954 79465050
Accidental death 19.03 9.51 44 272340 4247 79467757
Deafness 18.94 9.51 130 272254 20907 79451097
Symmetrical drug-related intertriginous and flexural exanthema 18.93 9.51 19 272365 867 79471137
Bladder prolapse 18.87 9.51 24 272360 1423 79470581
Ex-drug abuser 18.73 9.51 4 272380 0 79472004
Umbilical hernia 18.71 9.51 53 272331 5792 79466212
Insomnia 18.66 9.51 1020 271364 244150 79227854
Abdominal pain upper 18.61 9.51 939 271445 222880 79249124
Nasopharyngitis 18.41 9.51 695 271689 253186 79218818
Renal tubular necrosis 18.38 9.51 36 272348 25003 79447001
Bone lesion 18.30 9.51 53 272331 5866 79466138
Anaemia 18.29 9.51 1291 271093 443724 79028280
Caesarean section 18.28 9.51 10 272374 12525 79459479
Puncture site haematoma 18.25 9.51 10 272374 175 79471829
Hepatotoxicity 18.12 9.51 102 272282 51250 79420754
Drug tolerance decreased 18 9.51 11 272373 12967 79459037
Therapeutic response decreased 17.97 9.51 144 272240 66709 79405295
Product substitution 17.96 9.51 8 272376 87 79471917
Panniculitis 17.85 9.51 10 272374 12361 79459643
Erythema 17.84 9.51 604 271780 222686 79249318
Hyperreflexia 17.74 9.51 66 272318 8319 79463685
Sepsis 17.71 9.51 746 271638 268682 79203322
Pregnancy 17.71 9.51 41 272343 26810 79445194
Premenstrual syndrome 17.67 9.51 15 272369 551 79471453
Lymphopenia 17.58 9.51 50 272334 30507 79441497
Muscle disorder 17.54 9.51 51 272333 5656 79466348
Progressive multifocal leukoencephalopathy 17.51 9.51 27 272357 20573 79451431
Tonic convulsion 17.48 9.51 29 272355 2191 79469813
Bronchiectasis 17.48 9.51 31 272353 22355 79449649
Post stroke epilepsy 17.34 9.51 5 272379 12 79471992
Back pain 17.32 9.51 1234 271150 302946 79169058
Feeling drunk 17.32 9.51 45 272339 4674 79467330
Quality of life decreased 17.25 9.51 76 272308 10344 79461660
Blood pressure systolic increased 17.23 9.51 146 272238 66840 79405164
Aggression 17.22 9.51 257 272127 50701 79421303
Blood pressure fluctuation 16.97 9.51 147 272237 66998 79405006
Vasoplegia syndrome 16.96 9.51 38 272346 3592 79468412
Therapy non-responder 16.87 9.51 218 272166 92087 79379917
Mood swings 16.81 9.51 121 272263 19759 79452245
Pleural mesothelioma 16.78 9.51 7 272377 64 79471940
Accidental exposure to product 16.76 9.51 53 272331 31269 79440735
Tenosynovitis 16.76 9.51 17 272367 15537 79456467
Incorrect route of product administration 16.73 9.51 62 272322 34867 79437137
Disinhibition 16.65 9.51 31 272353 2567 79469437
Hanging 16.60 9.51 9 272375 154 79471850
Mania 16.53 9.51 113 272271 18147 79453857
Cardiac disorder 16.50 9.51 316 272068 65441 79406563
Cushingoid 16.47 9.51 6 272378 9546 79462458
Foot operation 16.45 9.51 50 272334 5683 79466321
Allodynia 16.43 9.51 24 272360 1624 79470380
Bronchopulmonary aspergillosis 16.41 9.51 32 272352 22262 79449742
Myelodysplastic syndrome 16.41 9.51 51 272333 30250 79441754
Snoring 16.41 9.51 49 272335 5517 79466487
Pseudoporphyria 16.32 9.51 15 272369 613 79471391
Adverse reaction 16.24 9.51 69 272315 9245 79462759
Thymus disorder 16.23 9.51 11 272373 286 79471718
Oedematous pancreatitis 16.23 9.51 20 272364 1148 79470856
Anal haemorrhage 16.19 9.51 41 272343 4193 79467811
Fear of disease 16.17 9.51 21 272363 1271 79470733
Multiple-drug resistance 16.11 9.51 5 272379 8803 79463201
BK virus infection 16.10 9.51 5 272379 8799 79463205
Cardiac failure 16.10 9.51 404 271980 154438 79317566
Device ineffective 15.81 9.51 9 272375 170 79471834
Pancytopenia 15.77 9.51 438 271946 165307 79306697
Secondary adrenocortical insufficiency 15.74 9.51 33 272351 2981 79469023
Aspartate aminotransferase increased 15.72 9.51 357 272027 138284 79333720
Dyspnoea 15.70 9.51 2631 269753 854394 78617610
Thermal burn 15.69 9.51 57 272327 7103 79464901
Hypothermia 15.66 9.51 132 272252 22614 79449390
Vaccination site reaction 15.63 9.51 8 272376 121 79471883
Lung neoplasm malignant 15.61 9.51 46 272338 27746 79444258
Drug level below therapeutic 15.44 9.51 7 272377 9763 79462241
Faecal disimpaction 15.44 9.51 5 272379 20 79471984
Fluid retention 15.43 9.51 158 272226 69651 79402353
Back injury 15.38 9.51 74 272310 10449 79461555
Polymenorrhoea 15.30 9.51 18 272366 984 79471020
Swollen tongue 15.30 9.51 217 272167 42353 79429651
Performance enhancing product use 15.26 9.51 7 272377 82 79471922
Product label confusion 15.24 9.51 23 272361 1603 79470401
Surgery 15.15 9.51 175 272209 32591 79439413
Trigger finger 15.09 9.51 40 272344 4205 79467799
Musculoskeletal disorder 15.05 9.51 125 272259 21323 79450681
Subileus 15.02 9.51 48 272336 5606 79466398
Urticaria 15.02 9.51 500 271884 184701 79287303
Immunosuppressant drug level increased 15.01 9.51 6 272378 9021 79462983
Lip pruritus 14.96 9.51 17 272367 895 79471109
Pharyngitis 14.96 9.51 129 272255 22246 79449758
Ventricular tachycardia 14.95 9.51 83 272301 41852 79430152
Postmortem blood drug level increased 14.86 9.51 16 272368 793 79471211
Spinal operation 14.86 9.51 60 272324 7857 79464147
Acidosis 14.86 9.51 117 272267 19645 79452359
Enterococcal infection 14.83 9.51 19 272365 15641 79456363
Labelled drug-drug interaction issue 14.71 9.51 21 272363 1392 79470612
Mixed liver injury 14.68 9.51 58 272326 7520 79464484
Blood glucose increased 14.51 9.51 291 272093 114684 79357320
Magnesium deficiency 14.48 9.51 14 272370 610 79471394
Respiratory rate decreased 14.37 9.51 45 272339 5198 79466806
Visceral pain 14.35 9.51 7 272377 95 79471909
Polyneuropathy in malignant disease 14.17 9.51 10 272374 278 79471726
Breast cancer stage II 14.17 9.51 5 272379 8115 79463889
Inflammation 14.13 9.51 230 272154 93523 79378481
Fear of injection 14.12 9.51 4 272380 7470 79464534
Gallbladder cholesterolosis 14.07 9.51 14 272370 632 79471372
Ligament calcification 14.06 9.51 9 272375 212 79471792
Hepatitis 14.05 9.51 268 272116 55459 79416545
Electrocution 14.05 9.51 3 272381 0 79472004
Vascular purpura 13.99 9.51 32 272352 3066 79468938
Rectal prolapse 13.97 9.51 26 272358 2152 79469852
Injection site pain 13.97 9.51 337 272047 129501 79342503
Abdominal pain lower 13.93 9.51 168 272216 31614 79440390
Foaming at mouth 13.91 9.51 24 272360 1873 79470131
Cystitis haemorrhagic 13.84 9.51 7 272377 9165 79462839
Gallbladder polyp 13.84 9.51 17 272367 973 79471031
Oral discomfort 13.81 9.51 68 272316 9692 79462312
Product administration error 13.81 9.51 168 272216 31678 79440326
Blood bilirubin increased 13.79 9.51 152 272232 66080 79405924
Lichen sclerosus 13.78 9.51 17 272367 977 79471027
Hypoaesthesia oral 13.75 9.51 89 272295 14035 79457969
Tinnitus 13.61 9.51 220 272164 44113 79427891
Growth disorder 13.52 9.51 5 272379 32 79471972
Mucormycosis 13.49 9.51 6 272378 8463 79463541
Arthrofibrosis 13.39 9.51 7 272377 111 79471893
Product used for unknown indication 13.29 9.51 21 272363 1523 79470481
Anterograde amnesia 13.29 9.51 14 272370 677 79471327
Wrong rate 13.26 9.51 6 272378 68 79471936
Autoimmune haemolytic anaemia 13.25 9.51 6 272378 8374 79463630
Feeling abnormal 13.25 9.51 668 271716 158531 79313473
Hyperthermia 13.13 9.51 106 272278 17931 79454073
Vasculitis 13.07 9.51 43 272341 25059 79446945
Hepatic cirrhosis 13.05 9.51 68 272316 34838 79437166
Lumbar radiculopathy 13.00 9.51 24 272360 1975 79470029
Second primary malignancy 12.99 9.51 18 272366 14332 79457672
Pulmonary alveolar haemorrhage 12.95 9.51 12 272372 11445 79460559
Aplastic anaemia 12.92 9.51 26 272358 17879 79454125
Lymphoma 12.91 9.51 25 272359 17435 79454569
Therapy partial responder 12.78 9.51 25 272359 17372 79454632
Blood pressure decreased 12.77 9.51 251 272133 99215 79372789
Sinus congestion 12.63 9.51 31 272353 19865 79452139
Back disorder 12.55 9.51 75 272309 11503 79460501
Oesophagitis chemical 12.53 9.51 6 272378 78 79471926
Manipulation 12.53 9.51 6 272378 78 79471926
Pneumonia viral 12.37 9.51 8 272376 9150 79462854
Purple glove syndrome 12.37 9.51 9 272375 263 79471741
Withdrawal catatonia 12.19 9.51 8 272376 197 79471807
Hypopnoea 12.17 9.51 43 272341 5286 79466718
Anoxia 12.16 9.51 10 272374 351 79471653
Prothrombin level increased 12.12 9.51 11 272373 442 79471562
Spleen congestion 12.10 9.51 11 272373 443 79471561
Femoral artery aneurysm 12.08 9.51 8 272376 200 79471804
Ulcer 12 9.51 57 272327 29915 79442089
Thecal sac compression 11.98 9.51 3 272381 3 79472001
Coagulopathy 11.91 9.51 73 272311 35933 79436071
Diabetes mellitus 11.91 9.51 192 272192 78198 79393806
Hypokalaemia 11.90 9.51 604 271780 143436 79328568
Pulmonary toxicity 11.89 9.51 16 272368 12898 79459106
Ill-defined disorder 11.88 9.51 156 272228 65719 79406285
Sinusitis 11.88 9.51 546 271838 194955 79277049
Pulmonary fibrosis 11.86 9.51 95 272289 44017 79427987
Lip erosion 11.78 9.51 20 272364 1540 79470464
Narcolepsy 11.78 9.51 18 272366 1268 79470736
Hypersensitivity vasculitis 11.77 9.51 51 272333 6892 79465112
Infective pulmonary exacerbation of cystic fibrosis 11.75 9.51 16 272368 12835 79459169
Poor venous access 11.74 9.51 28 272356 18121 79453883
Organising pneumonia 11.74 9.51 12 272372 10927 79461077
Appetite disorder 11.73 9.51 55 272329 7684 79464320
Haemorrhage 11.68 9.51 230 272154 90888 79381116
Carcinoembryonic antigen 11.65 9.51 6 272378 92 79471912
Myasthenia gravis 11.63 9.51 11 272373 10388 79461616
Skin toxicity 11.60 9.51 7 272377 8307 79463697
Lymphadenopathy 11.57 9.51 121 272263 53126 79418878
Logorrhoea 11.54 9.51 37 272347 4328 79467676
Neuroglycopenia 11.50 9.51 11 272373 473 79471531
Carbohydrate antigen 15-3 11.48 9.51 6 272378 95 79471909
Hypoventilation 11.44 9.51 52 272332 7172 79464832
Optic nerve operation 11.39 9.51 11 272373 479 79471525
Compulsive shopping 11.38 9.51 14 272370 802 79471202
Product dispensing error 11.37 9.51 81 272303 13182 79458822
Feeling jittery 11.35 9.51 79 272305 12762 79459242
Haematuria 11.34 9.51 166 272218 68670 79403334
Temperature regulation disorder 11.30 9.51 3 272381 5850 79466154
Visual acuity reduced 11.25 9.51 57 272327 29412 79442592
Respiratory rate increased 11.25 9.51 37 272347 21563 79450441
Tongue disorder 11.23 9.51 19 272365 13956 79458048
Disseminated intravascular coagulation 11.18 9.51 74 272310 35768 79436236
Drooling 11.16 9.51 45 272339 5889 79466115
Gastric cancer 11.11 9.51 11 272373 10168 79461836
Electrocardiogram QT interval 11.08 9.51 8 272376 231 79471773
Livedo reticularis 11.05 9.51 35 272349 4068 79467936
Scrotal infection 11.05 9.51 12 272372 601 79471403
Middle insomnia 11.04 9.51 24 272360 16045 79455959
Post cardiac arrest syndrome 11.03 9.51 4 272380 24 79471980
Prothrombin time prolonged 10.99 9.51 26 272358 16873 79455131
Complications of transplanted kidney 10.97 9.51 4 272380 6362 79465642
Immune reconstitution inflammatory syndrome 10.96 9.51 19 272365 13822 79458182
Flushing 10.96 9.51 224 272160 88044 79383960
Rotator cuff syndrome 10.90 9.51 84 272300 14011 79457993
Drug dependence, antepartum 10.89 9.51 4 272380 25 79471979
Depressed mood 10.84 9.51 229 272155 48251 79423753
Resting tremor 10.83 9.51 19 272365 1502 79470502
Bladder dilatation 10.83 9.51 23 272361 2096 79469908
Electric shock sensation 10.81 9.51 14 272370 845 79471159
Cell death 10.80 9.51 38 272346 4661 79467343
Peritoneal perforation 10.79 9.51 7 272377 169 79471835
Syringe issue 10.78 9.51 4 272380 6294 79465710
Alcoholic seizure 10.77 9.51 3 272381 6 79471998
Oropharyngeal neoplasm 10.77 9.51 3 272381 6 79471998
Subarachnoid haemorrhage 10.72 9.51 45 272339 24420 79447584
Haemolysis 10.69 9.51 17 272367 12795 79459209
Decreased immune responsiveness 10.68 9.51 42 272342 5433 79466571
Theft 10.67 9.51 8 272376 245 79471759
Lymphoproliferative disorder 10.61 9.51 3 272381 5612 79466392
Papilloedema 10.60 9.51 4 272380 6229 79465775
Retinal toxicity 10.54 9.51 18 272366 1393 79470611
No adverse event 10.51 9.51 79 272305 37113 79434891
Dehydration 10.51 9.51 718 271666 247469 79224535
Diastolic hypotension 10.50 9.51 7 272377 177 79471827
Methaemoglobinaemia 10.45 9.51 3 272381 5554 79466450
Hypoosmolar state 10.43 9.51 9 272375 338 79471666
Renal cancer 10.41 9.51 16 272368 12210 79459794
Menstruation delayed 10.40 9.51 18 272366 1408 79470596
Blood phosphorus increased 10.38 9.51 12 272372 10335 79461669
Drug level decreased 10.32 9.51 21 272363 14381 79457623
Pre-existing condition improved 10.32 9.51 42 272342 5521 79466483
Injection site swelling 10.28 9.51 107 272277 47025 79424979
Basal cell carcinoma 10.28 9.51 80 272304 37295 79434709
Central-alveolar hypoventilation 10.27 9.51 4 272380 30 79471974
Burning mouth syndrome 10.27 9.51 11 272373 542 79471462
Oral lichenoid reaction 10.20 9.51 6 272378 121 79471883
Gastritis 10.19 9.51 225 272159 47768 79424236
Acquired cystic kidney disease 10.18 9.51 5 272379 69 79471935
Dermo-hypodermitis 10.16 9.51 13 272371 775 79471229
Haemorrhagic fever 10.16 9.51 4 272380 31 79471973
Injection site erythema 10.14 9.51 197 272187 78000 79394004
Orthostatic hypotension 10.13 9.51 133 272251 56031 79415973
Metastases to liver 10.12 9.51 56 272328 28258 79443746
Hip arthroplasty 10.08 9.51 76 272308 35680 79436324
Enthesopathy 10.07 9.51 15 272369 11593 79460411
Unintentional medical device removal 10.07 9.51 7 272377 7705 79464299
Body temperature increased 10.04 9.51 100 272284 44320 79427684
Hot flush 10.03 9.51 252 272132 54625 79417379
Retinal haemorrhage 10.03 9.51 8 272376 8209 79463795
Dermatitis bullous 10.01 9.51 21 272363 14224 79457780
Activated partial thromboplastin time prolonged 9.98 9.51 21 272363 14207 79457797
Pleural neoplasm 9.97 9.51 9 272375 359 79471645
Discoloured vomit 9.93 9.51 18 272366 1460 79470544
Perineal infection 9.92 9.51 13 272371 794 79471210
Carotid pulse abnormal 9.92 9.51 3 272381 9 79471995
Mouth swelling 9.92 9.51 44 272340 6007 79465997
Chemical poisoning 9.91 9.51 7 272377 195 79471809
Cystitis noninfective 9.88 9.51 17 272367 1323 79470681
Sweat gland disorder 9.88 9.51 7 272377 196 79471808
Rheumatic fever 9.88 9.51 57 272327 28468 79443536
Liver disorder 9.83 9.51 181 272203 72236 79399768
Dysphonia 9.77 9.51 259 272125 56613 79415391
Breast cancer female 9.76 9.51 15 272369 11446 79460558
Hyperinsulinaemia 9.76 9.51 7 272377 200 79471804
Postictal paralysis 9.73 9.51 9 272375 371 79471633
Prostate cancer 9.72 9.51 70 272314 33198 79438806
Granulocytopenia 9.70 9.51 15 272369 11416 79460588
Rheumatoid arthritis 9.69 9.51 598 271786 207872 79264132
Accidental poisoning 9.67 9.51 19 272365 1638 79470366
Incontinence 9.65 9.51 82 272302 14082 79457922
Respiratory depth decreased 9.64 9.51 4 272380 36 79471968
Capillary fragility 9.64 9.51 7 272377 204 79471800
Hyperbilirubinaemia 9.60 9.51 47 272337 24471 79447533
Endophthalmitis 9.56 9.51 5 272379 6423 79465581
Alcohol abuse 9.56 9.51 40 272344 5323 79466681
Limb fracture 9.55 9.51 4 272380 37 79471967
Wrong product administered 9.53 9.51 58 272326 8954 79463050

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC N02AJ13 NERVOUS SYSTEM
ANALGESICS
OPIOIDS
Opioids in combination with non-opioid analgesics
ATC N02AJ14 NERVOUS SYSTEM
ANALGESICS
OPIOIDS
Opioids in combination with non-opioid analgesics
ATC N02AJ15 NERVOUS SYSTEM
ANALGESICS
OPIOIDS
Opioids in combination with non-opioid analgesics
ATC N02AJ16 NERVOUS SYSTEM
ANALGESICS
OPIOIDS
Opioids in combination with non-opioid analgesics
ATC N02AX02 NERVOUS SYSTEM
ANALGESICS
OPIOIDS
Other opioids
CHEBI has role CHEBI:35482 narcotic analgesic
CHEBI has role CHEBI:35640 adrenergic uptake inhibitors
CHEBI has role CHEBI:35703 Xenobiotic
CHEBI has role CHEBI:48279 serotonin antagonists
CHEBI has role CHEBI:48876 muscarinic antagonists
CHEBI has role CHEBI:48878 nicotinic antagonists
CHEBI has role CHEBI:50949 SSRI
CHEBI has role CHEBI:51177 anti-tussive
CHEBI has role CHEBI:55322 mu-opioid agonists
CHEBI has role CHEBI:59282 kappa-opioid receptor agonists
CHEBI has role CHEBI:60643 N-methyl-D-aspartate receptor antagonists
CHEBI has role CHEBI:70774 vanilloid receptor 1 antagonists
CHEBI has role CHEBI:78298 environmental contaminants
FDA MoA N0000175684 Full Opioid Agonists
FDA EPC N0000175690 Opioid Agonist
MeSH PA D000700 Analgesics
MeSH PA D000701 Analgesics, Opioid
MeSH PA D002491 Central Nervous System Agents
MeSH PA D002492 Central Nervous System Depressants
MeSH PA D009294 Narcotics
MeSH PA D018373 Peripheral Nervous System Agents
MeSH PA D018689 Sensory System Agents

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

DiseaseRelationSNOMED_IDDOID
Pain indication 22253000
Chronic pain indication 82423001
Osteoarthritis indication 396275006
Fibromyalgia off-label use 203082005 DOID:631
Neuropathic pain off-label use 247398009
Suicidal thoughts contraindication 6471006
Alcoholism contraindication 7200002
Lowered convulsive threshold contraindication 19260006
Cirrhosis of liver contraindication 19943007 DOID:5082
Alcohol intoxication contraindication 25702006
Depressive disorder contraindication 35489007
Hypertensive disorder contraindication 38341003 DOID:10763
Hyperlipidemia contraindication 55822004 DOID:1168
Acute nephropathy contraindication 58574008
Hepatic failure contraindication 59927004
Substance abuse contraindication 66214007
Benign intracranial hypertension contraindication 68267002 DOID:11459
Poisoning by acetaminophen contraindication 70273001
Diabetes mellitus contraindication 73211009 DOID:9351
Decreased respiratory function contraindication 80954004
Injury of head contraindication 82271004
Epilepsy contraindication 84757009 DOID:1826
Infectious disease of central nervous system contraindication 128117002
Seizure disorder contraindication 128613002
Alcohol withdrawal syndrome contraindication 191480000
Disease of liver contraindication 235856003 DOID:409
Poisoning by opiate analgesic drug contraindication 241749009
Suicidal contraindication 267073005
Pregnancy, function contraindication 289908002
Drug withdrawal contraindication 363101005
Serotonin syndrome contraindication 371089000
Central nervous system depression contraindication 418072004
Benzodiazepine Toxicity contraindication




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 9.01 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
56MG;44MG SEGLENTIS KOWA PHARMS N213426 Oct. 15, 2021 RX TABLET ORAL 10238668 April 19, 2030 A METHOD FOR TREATMENT OF PAIN IN ADULTS USING TRAMADOL HYDROCHLORIDE AND CELECOXIB
56MG;44MG SEGLENTIS KOWA PHARMS N213426 Oct. 15, 2021 RX TABLET ORAL 10548909 April 19, 2030 A METHOD FOR TREATMENT OF PAIN IN ADULTS USING TRAMADOL HYDROCHLORIDE AND CELECOXIB
56MG;44MG SEGLENTIS KOWA PHARMS N213426 Oct. 15, 2021 RX TABLET ORAL 11478488 April 19, 2030 A METHOD FOR TREATMENT OF PAIN IN ADULTS USING TRAMADOL HYDROCHLORIDE AND CELECOXIB
5MG/ML QDOLO ATHENA N214044 Sept. 1, 2020 RX SOLUTION ORAL 11103452 Sept. 1, 2040 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE AN OPIOID ANALGESIC AND FOR WHICH ALTERNATIVE TREATMENTS ARE INADEQUATE

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
56MG;44MG SEGLENTIS KOWA PHARMS N213426 Oct. 15, 2021 RX TABLET ORAL Oct. 15, 2024 NEW PRODUCT

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])		Mechanism
action		Bioact sourceMoA source
Mu-type opioid receptor GPCR AGONIST Ki 5.80 CHEMBL CHEMBL
Sodium-dependent serotonin transporter Transporter IC50 5.83 CHEMBL
Sodium-dependent noradrenaline transporter Transporter IC50 6.10 CHEMBL
Kappa-type opioid receptor GPCR Ki 7.85 CHEMBL
Delta-type opioid receptor GPCR Ki 8.03 CHEMBL
Solute carrier family 22 member 1 Transporter IC50 4.28 WOMBAT-PK
Mu-type opioid receptor GPCR Ki 5.62 CHEMBL

External reference:

IDSource
4023985 VUID
N0000021990 NUI
D01355 KEGG_DRUG
36282-47-0 SECONDARY_CAS_RN
4020912 VANDF
4023985 VANDF
C0040610 UMLSCUI
CHEBI:9648 CHEBI
CHEMBL1237044 ChEMBL_ID
DB00193 DRUGBANK_ID
CHEMBL1237065 ChEMBL_ID
D014147 MESH_DESCRIPTOR_UI
33741 PUBCHEM_CID
8286 IUPHAR_LIGAND_ID
2722 INN_ID
39J1LGJ30J UNII
10689 RXNORM
44050 MMSL
5605 MMSL
d03826 MMSL
004180 NDDF
004181 NDDF
108505002 SNOMEDCT_US
108507005 SNOMEDCT_US
386858008 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Tramadol Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0093-0058 TABLET, FILM COATED 50 mg ORAL ANDA 29 sections
Tramadol Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0093-0058 TABLET, FILM COATED 50 mg ORAL ANDA 29 sections
Tramadol Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0378-4151 TABLET, FILM COATED 50 mg ORAL ANDA 37 sections
Tramadol Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0378-4152 TABLET, EXTENDED RELEASE 100 mg ORAL ANDA 35 sections
Tramadol Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0378-4153 TABLET, EXTENDED RELEASE 200 mg ORAL ANDA 35 sections
Tramadol Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0378-4154 TABLET, EXTENDED RELEASE 300 mg ORAL ANDA 35 sections
Tramadol Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0615-7810 TABLET, FILM COATED 50 mg ORAL ANDA 28 sections
Tramadol Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0615-8005 TABLET, COATED 50 mg ORAL ANDA 14 sections
Tramadol Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0615-8005 TABLET, COATED 50 mg ORAL ANDA 14 sections
TRAMADOL HYDROCHLORIDE HUMAN PRESCRIPTION DRUG LABEL 1 0904-6365 TABLET, FILM COATED 50 mg ORAL ANDA 31 sections
tramadol hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0904-7179 TABLET 50 mg ORAL ANDA 33 sections
Tramadol Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 10544-009 TABLET 50 mg ORAL ANDA 17 sections
Tramadol Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 10544-531 TABLET 50 mg ORAL ANDA 16 sections
TRAMADOL HYDROCHLORIDE HUMAN PRESCRIPTION DRUG LABEL 1 12634-786 TABLET 50 mg ORAL ANDA 16 sections
Tramadol HydrochlorideExtended-Release HUMAN PRESCRIPTION DRUG LABEL 1 13811-689 CAPSULE 100 mg ORAL NDA AUTHORIZED GENERIC 38 sections
Tramadol HydrochlorideExtended-Release HUMAN PRESCRIPTION DRUG LABEL 1 13811-689 CAPSULE 100 mg ORAL NDA AUTHORIZED GENERIC 38 sections
Tramadol HydrochlorideExtended-Release HUMAN PRESCRIPTION DRUG LABEL 1 13811-690 CAPSULE 200 mg ORAL NDA AUTHORIZED GENERIC 38 sections
Tramadol HydrochlorideExtended-Release HUMAN PRESCRIPTION DRUG LABEL 1 13811-690 CAPSULE 200 mg ORAL NDA AUTHORIZED GENERIC 38 sections
Tramadol HydrochlorideExtended-Release HUMAN PRESCRIPTION DRUG LABEL 1 13811-691 CAPSULE 300 mg ORAL NDA AUTHORIZED GENERIC 38 sections
Tramadol HydrochlorideExtended-Release HUMAN PRESCRIPTION DRUG LABEL 1 13811-691 CAPSULE 300 mg ORAL NDA AUTHORIZED GENERIC 38 sections
Tramadol Hydrochloride Human Prescription Drug Label 1 16571-716 TABLET, FILM COATED 50 mg ORAL ANDA 31 sections
Tramadol Hydrochloride Human Prescription Drug Label 1 16571-716 TABLET, FILM COATED 50 mg ORAL ANDA 31 sections
TRAMADOL HYDROCHLORIDE HUMAN PRESCRIPTION DRUG LABEL 1 16590-229 TABLET 50 mg ORAL ANDA 28 sections
Tramadol Hydrochloride and Acetaminophen HUMAN PRESCRIPTION DRUG LABEL 2 16590-230 TABLET, COATED 37.50 mg ORAL NDA 31 sections
RYZOLT HUMAN PRESCRIPTION DRUG LABEL 1 16590-244 TABLET, EXTENDED RELEASE 200 mg ORAL NDA 12 sections
RYZOLT HUMAN PRESCRIPTION DRUG LABEL 1 16590-253 TABLET, EXTENDED RELEASE 100 mg ORAL NDA 12 sections
RYZOLT HUMAN PRESCRIPTION DRUG LABEL 1 16590-255 TABLET, EXTENDED RELEASE 300 mg ORAL NDA 12 sections
Tramadol ER HUMAN PRESCRIPTION DRUG LABEL 1 16590-893 TABLET, EXTENDED RELEASE 200 mg ORAL ANDA 13 sections
Tramadol Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 21695-132 TABLET 50 mg ORAL ANDA 16 sections
ULTRACET HUMAN PRESCRIPTION DRUG LABEL 2 21695-143 TABLET 37.50 mg ORAL NDA 25 sections