tramadol ๐Ÿถ 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
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 ยตM/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 672.24 9.75 627 186652 24086 50393759
Drug dependence 577.66 9.75 522 186757 19237 50398608
Drug abuse 521.12 9.75 854 186425 58992 50358853
Toxicity to various agents 478.85 9.75 1799 185480 210700 50207145
Drug hypersensitivity 442.80 9.75 1970 185309 249040 50168805
Poisoning deliberate 409.01 9.75 292 186987 7620 50410225
Completed suicide 327.42 9.75 1153 186126 130736 50287109
Hand deformity 317.99 9.75 12 187267 100187 50317658
Glossodynia 303.01 9.75 36 187243 115533 50302312
Systemic lupus erythematosus 278.30 9.75 87 187192 140535 50277310
Contraindicated product administered 262.88 9.75 111 187168 148847 50268998
Prescription form tampering 235.30 9.75 86 187193 482 50417363
Anti-cyclic citrullinated peptide antibody positive 232.76 9.75 6 187273 70581 50347264
Deafness transitory 231.00 9.75 119 187160 1677 50416168
Somnolence 224.45 9.75 1150 186129 153835 50264010
Coma 221.78 9.75 583 186696 56296 50361549
Infusion related reaction 219.52 9.75 183 187096 169374 50248471
Pericarditis 217.84 9.75 20 187259 78669 50339176
Intentional overdose 209.33 9.75 606 186673 61898 50355947
Maternal exposure during pregnancy 208.62 9.75 171 187108 159607 50258238
Overdose 204.24 9.75 820 186459 98907 50318938
Withdrawal syndrome 204.02 9.75 287 186992 17303 50400542
Treatment failure 203.59 9.75 129 187150 137508 50280337
Gastrointestinal pain 201.10 9.75 195 187084 7861 50409984
Synovitis 180.58 9.75 118 187161 123747 50294098
Drug intolerance 179.45 9.75 336 186943 218768 50199077
Drug interaction 173.16 9.75 1298 185981 198323 50219522
Wound 165.08 9.75 93 187186 105701 50312144
Bradypnoea 162.45 9.75 115 187164 2959 50414886
Drug ineffective 162.00 9.75 2103 185176 817230 49600615
Alopecia 161.91 9.75 423 186856 244624 50173221
Drug withdrawal syndrome 157.99 9.75 311 186968 24770 50393075
Duodenal ulcer perforation 153.78 9.75 3 187276 45608 50372237
Joint swelling 143.95 9.75 448 186831 244838 50173007
Off label use 141.15 9.75 1103 186176 473323 49944522
Hepatic enzyme increased 140.77 9.75 181 187098 137199 50280646
Rheumatoid factor positive 137.11 9.75 13 187266 49846 50367999
Helicobacter infection 136.57 9.75 13 187266 49689 50368156
Miosis 135.92 9.75 141 187138 6169 50411676
Therapeutic product effect decreased 135.56 9.75 183 187096 135867 50281978
Mydriasis 131.64 9.75 179 187100 10448 50407397
Drug use disorder 120.20 9.75 96 187183 2976 50414869
Discomfort 118.19 9.75 136 187143 108244 50309601
Respiratory depression 112.08 9.75 177 187102 11833 50406012
Hepatocellular injury 111.51 9.75 276 187003 25671 50392174
Intentional product misuse 106.80 9.75 398 186881 46336 50371509
Exposure during pregnancy 104.89 9.75 179 187100 120836 50297009
Muscle injury 103.86 9.75 9 187270 37102 50380743
Folliculitis 98.47 9.75 14 187265 39211 50378634
Shoulder arthroplasty 96.64 9.75 89 187190 3359 50414486
Suicide attempt 94.57 9.75 411 186868 51321 50366524
Pharyngitis 90.30 9.75 200 187079 17303 50400542
Rash 89.59 9.75 1113 186166 436358 49981487
Fall 82.30 9.75 1716 185563 333216 50084629
Hallucination 76.53 9.75 359 186920 46298 50371547
Sensitisation 74.07 9.75 55 187224 1527 50416318
Derealisation 71.73 9.75 46 187233 1000 50416845
Device expulsion 70.70 9.75 11 187268 28811 50389034
Sleep disorder due to general medical condition, insomnia type 70.67 9.75 15 187264 31432 50386413
Abdominal discomfort 69.83 9.75 536 186743 231105 50186740
Impaired healing 69.33 9.75 94 187185 69692 50348153
Ear infection 68.61 9.75 232 187047 25738 50392107
Product use issue 65.57 9.75 307 186972 149168 50268677
Functional gastrointestinal disorder 65.46 9.75 72 187207 3370 50414475
Prescription drug used without a prescription 64.13 9.75 52 187227 1648 50416197
Vomiting 64.08 9.75 2191 185088 458567 49959278
Dependence 63.74 9.75 54 187225 1821 50416024
Swelling 62.81 9.75 460 186819 200412 50217433
Ejection fraction 61.35 9.75 44 187235 1156 50416689
Feeding disorder 61.34 9.75 127 187152 10486 50407359
Dizziness 61.14 9.75 1696 185583 344673 50073172
Nausea 60.32 9.75 3187 184092 702211 49715634
Depersonalisation/derealisation disorder 59.13 9.75 43 187236 1155 50416690
Arthropathy 58.25 9.75 344 186935 157562 50260283
Polycystic ovaries 56.20 9.75 57 187222 2427 50415418
Hallucination, visual 55.68 9.75 161 187118 16421 50401424
Foot operation 55.32 9.75 84 187195 5426 50412419
Cholestasis 53.64 9.75 211 187068 25190 50392655
Drug abuser 53.51 9.75 59 187220 2769 50415076
Confusional state 53.47 9.75 976 186303 184952 50232893
Abnormal loss of weight 53.41 9.75 79 187200 4985 50412860
Drug diversion 53.35 9.75 34 187245 731 50417114
Clonus 52.74 9.75 71 187208 4104 50413741
Hypersensitivity 51.13 9.75 529 186750 214632 50203213
Lower respiratory tract infection 50.84 9.75 181 187098 95020 50322825
Gastric pH decreased 50.13 9.75 31 187248 631 50417214
Delirium 50.10 9.75 276 187003 37916 50379929
Respiratory acidosis 49.69 9.75 84 187195 5944 50411901
Asphyxia 49.29 9.75 79 187200 5348 50412497
Depression 46.73 9.75 866 186413 164557 50253288
Hyperhidrosis 46.47 9.75 521 186758 88905 50328940
Hyperacusis 45.65 9.75 44 187235 1760 50416085
Irritable bowel syndrome 45.55 9.75 75 187204 51366 50366479
Pyrexia 45.46 9.75 1066 186213 379137 50038708
Abortion spontaneous 44.88 9.75 53 187226 41719 50376126
Mycotic allergy 44.11 9.75 31 187248 788 50417057
Infection 44.09 9.75 418 186861 172536 50245309
Loss of consciousness 43.82 9.75 584 186695 103769 50314076
Cardio-respiratory arrest 43.57 9.75 345 186934 53547 50364298
Multiple drug therapy 43.01 9.75 44 187235 1893 50415952
Somatic symptom disorder 42.88 9.75 44 187235 1900 50415945
Constipation 42.75 9.75 943 186336 184765 50233080
Vertigo 42.55 9.75 333 186946 51499 50366346
Generalised tonic-clonic seizure 42.08 9.75 201 187078 26109 50391736
Hyponatraemia 42.02 9.75 542 186737 95597 50322248
Myocardial depression 41.70 9.75 24 187255 426 50417419
Decorticate posture 41.65 9.75 21 187258 282 50417563
Hypophagia 41.61 9.75 208 187071 27520 50390325
Feeling of despair 41.51 9.75 44 187235 1974 50415871
Rheumatoid arthritis 39.94 9.75 519 186760 202031 50215814
Chronic kidney disease 39.84 9.75 268 187011 39503 50378342
Analgesic drug level increased 39.67 9.75 40 187239 1691 50416154
Dissociation 38.59 9.75 45 187234 2246 50415599
Seizure 37.89 9.75 630 186649 117244 50300601
Red blood cell sedimentation rate increased 37.70 9.75 32 187247 29384 50388461
Agitation 37.43 9.75 331 186948 53053 50364792
Blood test abnormal 37.14 9.75 109 187170 11210 50406635
Suicidal ideation 37.09 9.75 340 186939 55045 50362800
H1N1 influenza 36.78 9.75 37 187242 1560 50416285
Muscle spasms 36.03 9.75 659 186620 124894 50292951
Rhinitis allergic 35.71 9.75 81 187198 7119 50410726
Myoclonus 35.38 9.75 126 187153 14344 50403501
Live birth 34.55 9.75 9 187270 16399 50401446
Rheumatoid nodule 33.27 9.75 4 187275 12731 50405114
Speech disorder 32.92 9.75 235 187044 35313 50382532
Musculoskeletal disorder 32.58 9.75 139 187140 17210 50400635
Sphincter of Oddi dysfunction 32.34 9.75 19 187260 351 50417494
Deafness 32.05 9.75 129 187150 15562 50402283
Ill-defined disorder 31.85 9.75 100 187179 54554 50363291
Pituitary tumour benign 31.71 9.75 36 187243 1745 50416100
Fibromyalgia 31.59 9.75 279 187000 44699 50373146
Psychotic disorder due to a general medical condition 31.53 9.75 16 187263 218 50417627
Leukopenia 31.20 9.75 136 187143 67392 50350453
Disturbance in attention 31.14 9.75 210 187069 30976 50386869
Poisoning 31.05 9.75 109 187170 12320 50405525
Fracture 30.95 9.75 134 187145 16699 50401146
Nephrectomy 30.36 9.75 25 187254 810 50417035
Pancreatic fibrosis 30.35 9.75 12 187267 86 50417759
Cyanosis 30.35 9.75 124 187155 15060 50402785
Abdominal pain upper 29.99 9.75 787 186492 158522 50259323
Carpal tunnel syndrome 29.93 9.75 133 187146 16760 50401085
Visceral congestion 29.88 9.75 17 187262 295 50417550
Stomatitis 29.78 9.75 236 187043 101108 50316737
Muscle rigidity 29.75 9.75 92 187187 9737 50408108
Sacroiliitis 29.55 9.75 42 187237 2555 50415290
Respiratory arrest 29.32 9.75 201 187078 29808 50388037
Tonic clonic movements 29.12 9.75 29 187250 1208 50416637
Sleep apnoea syndrome 29.00 9.75 169 187110 23699 50394146
Pain 28.91 9.75 1802 185477 577101 49840744
Caesarean section 28.62 9.75 11 187268 15628 50402217
Hepatic function abnormal 28.60 9.75 48 187231 32633 50385212
Ankylosing spondylitis 28.47 9.75 74 187205 7091 50410754
Cogwheel rigidity 28.44 9.75 34 187245 1743 50416102
Acute motor-sensory axonal neuropathy 28.41 9.75 16 187263 272 50417573
Drug resistance 27.77 9.75 18 187261 18971 50398874
Neutropenia 27.74 9.75 383 186896 147582 50270263
Febrile neutropenia 27.52 9.75 230 187049 97437 50320408
Peripheral circulatory failure 27.35 9.75 20 187259 542 50417303
Encephalopathy 27.34 9.75 216 187063 33495 50384350
Nightmare 27.27 9.75 125 187154 15961 50401884
Hallucinations, mixed 27.20 9.75 52 187227 4051 50413794
Hypothermia 27.16 9.75 102 187177 11914 50405931
Headache 27.03 9.75 2200 185079 504335 49913510
Limb injury 26.32 9.75 146 187133 20104 50397741
Coma scale abnormal 26.30 9.75 56 187223 4715 50413130
Product use in unapproved indication 26.16 9.75 288 186991 115531 50302314
Feeling of body temperature change 26.11 9.75 53 187226 4314 50413531
Blood creatinine increased 25.94 9.75 170 187109 75990 50341855
Hyperreflexia 25.85 9.75 58 187221 5060 50412785
Cestode infection 25.78 9.75 15 187264 272 50417573
Tinnitus 25.49 9.75 185 187094 27947 50389898
Drug eruption 25.30 9.75 30 187249 23576 50394269
Nasopharyngitis 25.26 9.75 533 186746 192394 50225451
Transplant rejection 25.15 9.75 3 187276 9606 50408239
Feeling abnormal 25.09 9.75 625 186654 124867 50292978
Blister 25.05 9.75 199 187080 85219 50332626
Cytomegalovirus infection 24.96 9.75 18 187261 17944 50399901
Disorientation 24.86 9.75 220 187059 35264 50382581
Injection site reaction 24.83 9.75 98 187181 49934 50367911
Skin necrosis 24.80 9.75 5 187274 10862 50406983
Premature baby 24.68 9.75 19 187260 18318 50399527
Blood cholesterol increased 23.83 9.75 114 187165 55101 50362744
Restless legs syndrome 23.67 9.75 119 187160 15778 50402067
Pregnancy 23.59 9.75 46 187233 29531 50388314
Accidental overdose 23.53 9.75 138 187141 19395 50398450
Eagle Barrett syndrome 23.48 9.75 6 187273 6 50417839
Myocardial fibrosis 23.37 9.75 20 187259 684 50417161
Type 2 diabetes mellitus 22.90 9.75 59 187220 34316 50383529
Muscle disorder 22.77 9.75 50 187229 4300 50413545
Unresponsive to stimuli 22.60 9.75 192 187087 30417 50387428
C-reactive protein increased 22.32 9.75 149 187130 66325 50351520
Hypoglycaemia 22.12 9.75 299 186980 53282 50364563
Tremor 22.01 9.75 569 186710 114334 50303511
Anxiety 21.96 9.75 834 186445 176772 50241073
Amnesia 21.84 9.75 246 187033 42014 50375831
Therapeutic product ineffective 21.48 9.75 25 187254 1245 50416600
Wrong technique in product usage process 21.48 9.75 119 187160 55391 50362454
Snoring 21.35 9.75 42 187237 3342 50414503
Drooling 21.35 9.75 42 187237 3342 50414503
Acute generalised exanthematous pustulosis 21.14 9.75 77 187202 8861 50408984
Depressed level of consciousness 21.07 9.75 289 186990 51664 50366181
Metastases to liver 21.07 9.75 26 187253 20078 50397767
Disease recurrence 21.02 9.75 26 187253 20055 50397790
Myelosuppression 20.90 9.75 12 187267 13505 50404340
Congenital central hypoventilation syndrome 20.87 9.75 7 187272 29 50417816
Haematoma muscle 20.81 9.75 19 187260 709 50417136
Urinary retention 20.26 9.75 166 187113 26024 50391821
Perineal fistula 20.14 9.75 7 187272 33 50417812
Hypertonia neonatal 19.95 9.75 12 187267 232 50417613
Burning sensation 19.75 9.75 256 187023 45190 50372655
Road traffic accident 19.73 9.75 156 187123 24196 50393649
Persistent genital arousal disorder 19.59 9.75 12 187267 240 50417605
Pancreatitis acute 19.55 9.75 153 187126 23659 50394186
Bone marrow failure 19.50 9.75 46 187233 27578 50390267
Behaviour disorder 19.40 9.75 33 187246 2347 50415498
Listless 19.30 9.75 33 187246 2357 50415488
Renal impairment 19.20 9.75 183 187096 75478 50342367
Restlessness 19.17 9.75 159 187120 25014 50392831
Accidental exposure to product 19.15 9.75 35 187244 23022 50394823
Heart rate decreased 19.07 9.75 70 187209 36427 50381418
Deep vein thrombosis 19.04 9.75 379 186900 72925 50344920
Device ineffective 19.04 9.75 10 187269 147 50417698
Vasoplegia syndrome 18.96 9.75 22 187257 1092 50416753
Hip arthroplasty 18.93 9.75 54 187225 30375 50387470
Parosmia 18.86 9.75 47 187232 4389 50413456
Pneumocystis jirovecii pneumonia 18.73 9.75 16 187263 14647 50403198
Congenital hypoplasia of depressor angularis oris muscle 18.41 9.75 4 187275 0 50417845
Thymus disorder 18.09 9.75 11 187268 217 50417628
Epilepsy 17.94 9.75 139 187140 21428 50396417
Brain injury 17.93 9.75 56 187223 5958 50411887
Intentional product use issue 17.87 9.75 190 187089 76728 50341117
Adverse reaction 17.86 9.75 71 187208 8515 50409330
Premature delivery 17.85 9.75 38 187241 23625 50394220
Muscle tone disorder 17.78 9.75 9 187270 122 50417723
Creatinine renal clearance decreased 17.73 9.75 11 187268 11870 50405975
Interstitial lung disease 17.45 9.75 120 187159 53056 50364789
Decreased appetite 17.45 9.75 910 186369 200013 50217832
Chemical submission 17.25 9.75 10 187269 180 50417665
Gallbladder polyp 17.15 9.75 17 187262 704 50417141
Body temperature increased 17.12 9.75 59 187220 31282 50386563
Feeling drunk 16.91 9.75 40 187239 3613 50414232
Secondary adrenocortical insufficiency 16.88 9.75 21 187258 1122 50416723
Ventricular hypokinesia 16.74 9.75 42 187237 3938 50413907
Blood calcium decreased 16.69 9.75 32 187247 20674 50397171
Performance enhancing product use 16.66 9.75 5 187274 13 50417832
Neuralgia 16.60 9.75 138 187141 21725 50396120
Drug detoxification 16.57 9.75 9 187270 142 50417703
Hypersensitivity vasculitis 16.50 9.75 42 187237 3973 50413872
Apnoea 16.47 9.75 60 187219 6906 50410939
Sedation complication 16.32 9.75 6 187273 8760 50409085
Weight increased 16.28 9.75 597 186682 201294 50216551
General physical health deterioration 16.23 9.75 402 186877 142032 50275813
Bone lesion 16.22 9.75 49 187230 5121 50412724
Menstrual disorder 16.21 9.75 44 187235 4326 50413519
Magnesium deficiency 16.18 9.75 14 187265 486 50417359
Intervertebral disc protrusion 16.17 9.75 130 187149 20263 50397582
Cardiogenic shock 16.15 9.75 106 187173 15493 50402352
Hypoacusis 16.04 9.75 131 187148 20516 50397329
Abdominal wound dehiscence 15.98 9.75 9 187270 153 50417692
Multiple organ dysfunction syndrome 15.83 9.75 115 187164 50222 50367623
Nephropathy toxic 15.80 9.75 5 187274 8024 50409821
Thrombocytopenia 15.75 9.75 356 186923 127317 50290528
Pneumonia 15.65 9.75 1197 186082 377204 50040641
Premenstrual syndrome 15.62 9.75 15 187264 597 50417248
Respiratory disorder 15.53 9.75 61 187218 31126 50386719
Eating disorder 15.52 9.75 104 187175 15305 50402540
Erythema 15.42 9.75 418 186861 145996 50271849
Anoxia 15.37 9.75 10 187269 223 50417622
Inappropriate antidiuretic hormone secretion 15.28 9.75 92 187187 13051 50404794
Paralysis 15.19 9.75 68 187211 8596 50409249
Hypoaesthesia oral 15.06 9.75 79 187200 10649 50407196
Enthesopathy 15.04 9.75 4 187275 7189 50410656
Lip pruritus 14.93 9.75 16 187263 727 50417118
Blood parathyroid hormone decreased 14.79 9.75 4 187275 7110 50410735
Insomnia 14.78 9.75 790 186489 174075 50243770
Allergy test negative 14.77 9.75 4 187275 6 50417839
Diastolic hypotension 14.65 9.75 7 187272 83 50417762
Antibiotic therapy 14.63 9.75 18 187261 951 50416894
Bladder prolapse 14.51 9.75 25 187254 1796 50416049
Central nervous system stimulation 14.49 9.75 5 187274 23 50417822
Coeliac disease 14.47 9.75 7 187272 8678 50409167
Wrong rate 14.40 9.75 6 187273 50 50417795
Thermal burn 14.36 9.75 45 187234 4796 50413049
Foaming at mouth 14.32 9.75 19 187260 1083 50416762
Growth disorder 14.31 9.75 5 187274 24 50417821
Alkalosis hypochloraemic 14.26 9.75 8 187271 135 50417710
Polymenorrhoea 14.19 9.75 19 187260 1092 50416753
Metastases to lung 14.11 9.75 12 187267 11008 50406837
Withdrawal catatonia 14.10 9.75 6 187273 53 50417792
Hypoventilation 14.07 9.75 39 187240 3882 50413963
Cholangiectasis acquired 14.05 9.75 4 187275 8 50417837
Congenital diaphragmatic eventration 14.05 9.75 4 187275 8 50417837
Accidental death 13.98 9.75 24 187255 1720 50416125
Foetal malnutrition 13.88 9.75 7 187272 94 50417751
Deformity 13.85 9.75 6 187273 7934 50409911
Neck pain 13.81 9.75 292 186987 56775 50361070
Cleft uvula 13.73 9.75 4 187275 9 50417836
Purple glove syndrome 13.71 9.75 9 187270 204 50417641
Disease progression 13.68 9.75 261 187018 95605 50322240
Haemodialysis 13.54 9.75 7 187272 8355 50409490
Fear of injection 13.53 9.75 3 187276 6100 50411745
Cholangiocarcinoma 13.51 9.75 18 187261 1030 50416815
C-reactive protein abnormal 13.46 9.75 55 187224 27754 50390091
Dry mouth 13.45 9.75 287 186992 55891 50361954
Victim of child abuse 13.44 9.75 4 187275 10 50417835
Diabetes mellitus inadequate control 13.41 9.75 89 187190 13056 50404789
Faecaloma 13.39 9.75 57 187222 7051 50410794
Gallbladder cholesterolosis 13.38 9.75 15 187264 717 50417128
Platelet count decreased 13.24 9.75 278 187001 100448 50317397
Ejection fraction abnormal 13.22 9.75 16 187263 831 50417014
Therapy non-responder 13.11 9.75 123 187156 50899 50366946
Blood pressure increased 13.02 9.75 384 186895 132748 50285097
Cerebral infarction 12.96 9.75 39 187240 21565 50396280
Haemoglobin decreased 12.92 9.75 365 186914 126851 50290994
Arthralgia 12.91 9.75 1424 185855 437278 49980567
Tuberculosis 12.88 9.75 11 187268 10072 50407773
Lichen sclerosus 12.82 9.75 17 187262 968 50416877
Prothrombin level increased 12.80 9.75 9 187270 229 50417616
Vascular encephalopathy 12.78 9.75 11 187268 379 50417466
Product dose omission issue 12.76 9.75 816 186463 183022 50234823
Knee arthroplasty 12.72 9.75 79 187200 35767 50382078
Sinusitis 12.72 9.75 509 186770 170049 50247796
Bruxism 12.70 9.75 32 187247 3008 50414837
Hypercapnic coma 12.68 9.75 8 187271 169 50417676
Congenital multiplex arthrogryposis 12.67 9.75 4 187275 13 50417832
Neonatal hypoxia 12.64 9.75 12 187267 471 50417374
Rectal prolapse 12.64 9.75 23 187256 1726 50416119
Pancytopenia 12.54 9.75 227 187052 83803 50334042
Gastritis 12.38 9.75 181 187098 32802 50385043
Lymphomatoid papulosis 12.38 9.75 7 187272 120 50417725
Psychomotor skills impaired 12.28 9.75 25 187254 2039 50415806
Pathogen resistance 12.21 9.75 3 187276 5686 50412159
Septic shock 12.19 9.75 144 187135 57031 50360814
Pneumonia viral 12.19 9.75 5 187274 6829 50411016
Gait disturbance 12.14 9.75 675 186604 149330 50268515
Narcolepsy 12.10 9.75 18 187261 1142 50416703
Eosinophil count increased 12.07 9.75 9 187270 8821 50409024
Eyelid myoclonus 12.07 9.75 5 187274 41 50417804
Mixed liver injury 12.06 9.75 34 187245 3417 50414428
Victim of chemical submission 11.99 9.75 9 187270 254 50417591
Obstructive airways disorder 11.92 9.75 25 187254 15627 50402218
Maternal exposure before pregnancy 11.92 9.75 3 187276 5594 50412251
Pre-existing condition improved 11.92 9.75 55 187224 7042 50410803
Transcription medication error 11.89 9.75 8 187271 189 50417656
Vitamin D decreased 11.87 9.75 62 187217 8344 50409501
Hypertonia 11.85 9.75 37 187242 3936 50413909
Nystagmus 11.80 9.75 3 187276 5558 50412287
Retinal toxicity 11.77 9.75 18 187261 1170 50416675
Cognitive disorder 11.75 9.75 229 187050 43894 50373951
Depressed mood 11.72 9.75 184 187095 33839 50384006
Labelled drug-drug interaction issue 11.64 9.75 9 187270 266 50417579
Foetal death 11.63 9.75 8 187271 8172 50409673
Nodular rash 11.60 9.75 8 187271 197 50417648
Degenerative bone disease 11.57 9.75 5 187274 46 50417799
Candida endophthalmitis 11.57 9.75 5 187274 46 50417799
Mood altered 11.57 9.75 84 187195 12689 50405156
Complication of device insertion 11.47 9.75 4 187275 6037 50411808
Haemolysis 11.40 9.75 4 187275 6012 50411833
Vocal cord dysfunction 11.39 9.75 10 187269 354 50417491
Injection site erythema 11.32 9.75 202 187077 74734 50343111
Acquired cystic kidney disease 11.30 9.75 5 187274 49 50417796
Oral discomfort 11.23 9.75 59 187220 7958 50409887
Panniculitis 11.20 9.75 9 187270 8494 50409351
Stillbirth 11.20 9.75 4 187275 5948 50411897
Epstein-Barr virus infection 11.12 9.75 6 187273 6991 50410854
Hypercapnia 11.06 9.75 40 187239 4587 50413258
Neuromyopathy 11.04 9.75 12 187267 554 50417291
Substance abuse 11.03 9.75 37 187242 4087 50413758
Bladder dilatation 11.02 9.75 14 187265 764 50417081
Abortion induced 10.98 9.75 11 187268 9333 50408512
No adverse event 10.90 9.75 76 187203 33502 50384343
Potentiating drug interaction 10.89 9.75 35 187244 3781 50414064
Moebius II syndrome 10.86 9.75 4 187275 23 50417822
Myelodysplastic syndrome 10.84 9.75 25 187254 15107 50402738
Gait inability 10.84 9.75 195 187084 36832 50381013
Hepatic enzyme abnormal 10.82 9.75 41 187238 4808 50413037
Multiple injuries 10.73 9.75 21 187258 1665 50416180
Post cardiac arrest syndrome 10.72 9.75 4 187275 24 50417821
Foreign body 10.71 9.75 23 187256 1948 50415897
Mood swings 10.70 9.75 98 187181 15856 50401989
Surgery 10.65 9.75 164 187115 30041 50387804
Dyspnoea 10.59 9.75 1824 185455 545784 49872061
Life support 10.56 9.75 8 187271 229 50417616
Intestinal diaphragm disease 10.55 9.75 6 187273 104 50417741
VIIIth nerve injury 10.54 9.75 3 187276 6 50417839
Porphyria acute 10.51 9.75 11 187268 486 50417359
Porphyria 10.49 9.75 7 187272 163 50417682
Therapeutic response decreased 10.44 9.75 118 187161 47113 50370732
Hyperkalaemia 10.29 9.75 121 187158 47968 50369877
Livedo reticularis 10.29 9.75 24 187255 2148 50415697
Lymphopenia 10.26 9.75 27 187252 15594 50402251
Emotional disorder 10.24 9.75 77 187202 11759 50406086
Pulmonary fibrosis 10.23 9.75 51 187228 24386 50393459
Convulsions local 10.22 9.75 3 187276 7 50417838
Sensory loss 10.20 9.75 56 187223 7682 50410163
Neutrophil count decreased 10.17 9.75 115 187164 45911 50371934
Somnolence neonatal 10.16 9.75 6 187273 112 50417733
Vasculitis 10.12 9.75 23 187256 13968 50403877
Burning mouth syndrome 10.11 9.75 10 187269 413 50417432
Back disorder 10.10 9.75 64 187215 9241 50408604
Clonic convulsion 9.99 9.75 12 187267 618 50417227
Tachycardia 9.93 9.75 458 186821 99305 50318540
Knee operation 9.90 9.75 40 187239 4833 50413012
Herpes zoster oticus 9.85 9.75 8 187271 254 50417591
Respiratory depth decreased 9.85 9.75 4 187275 31 50417814
Anticholinergic syndrome 9.81 9.75 21 187258 1774 50416071
Peritoneal perforation 9.79 9.75 6 187273 120 50417725
Tearfulness 9.79 9.75 33 187246 3654 50414191

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 800.80 10.38 598 90145 20383 29463401
Drug abuse 752.81 10.38 1068 89675 78815 29404969
Toxicity to various agents 403.71 10.38 1309 89434 172352 29311432
Prescription form tampering 403.37 10.38 117 90626 335 29483449
Overdose 337.97 10.38 752 89991 79067 29404717
Serotonin syndrome 317.69 10.38 327 90416 17185 29466599
Poisoning deliberate 294.34 10.38 196 90547 5535 29478249
Intentional overdose 279.80 10.38 457 90286 38071 29445713
Coma 254.68 10.38 444 90299 39006 29444778
Drug use disorder 246.28 10.38 145 90598 3277 29480507
Withdrawal syndrome 224.62 10.38 219 90524 10773 29473011
Intentional product misuse 223.57 10.38 390 90353 34271 29449513
Miosis 191.28 10.38 174 90569 7835 29475949
Somnolence 112.13 10.38 577 90166 93378 29390406
Bradypnoea 109.62 10.38 76 90667 2295 29481489
Drug abuser 109.17 10.38 92 90651 3735 29480049
Respiratory depression 97.52 10.38 160 90583 13363 29470421
Suicide attempt 92.60 10.38 272 90471 33838 29449946
Confusional state 91.23 10.38 688 90055 127189 29356595
Seizure 89.81 10.38 540 90203 92583 29391201
Off label use 89.53 10.38 549 90194 300251 29183533
Drug dispensed to wrong patient 88.84 10.38 33 90710 242 29483542
Prescription drug used without a prescription 87.95 10.38 53 90690 1251 29482533
Generalised tonic-clonic seizure 80.43 10.38 180 90563 18959 29464825
Asphyxia 80.07 10.38 90 90653 5225 29478559
Completed suicide 75.64 10.38 505 90238 89741 29394043
Wrong patient received product 63.33 10.38 54 90689 2228 29481556
Mydriasis 61.02 10.38 84 90659 6001 29477783
Poisoning 58.68 10.38 108 90635 9885 29473899
Housebound 57.65 10.38 23 90720 209 29483575
Drug withdrawal syndrome 57.25 10.38 152 90591 17832 29465952
Hepatocellular injury 56.30 10.38 168 90575 21075 29462709
Dependence 54.59 10.38 36 90707 999 29482785
Depressed level of consciousness 49.05 10.38 234 90509 36708 29447076
Drug hypersensitivity 48.66 10.38 368 90375 68038 29415746
Drug resistance 48.20 10.38 5 90738 21535 29462249
Drug tolerance 44.16 10.38 43 90700 2110 29481674
Hypoglycaemia 42.56 10.38 274 90469 48072 29435712
Constipation 40.79 10.38 532 90211 113628 29370156
Product use in unapproved indication 40.50 10.38 134 90609 86741 29397043
Mixed anxiety and depressive disorder 39.19 10.38 10 90733 14 29483770
Loss of consciousness 37.74 10.38 370 90373 73686 29410098
Antimicrobial susceptibility test resistant 37.50 10.38 18 90725 264 29483520
Disorientation 37.05 10.38 184 90559 29331 29454453
Hallucination 36.69 10.38 249 90494 44463 29439321
Cholestasis 36.67 10.38 156 90587 23306 29460478
Myoclonus 35.97 10.38 106 90637 13203 29470581
Analgesic drug level above therapeutic 35.93 10.38 17 90726 241 29483543
Febrile neutropenia 35.81 10.38 200 90543 112040 29371744
Antidepressant drug level above therapeutic 35.00 10.38 15 90728 166 29483618
Disease progression 34.41 10.38 132 90611 81784 29402000
Epilepsy 33.96 10.38 129 90614 18303 29465481
Treatment failure 33.84 10.38 38 90705 36901 29446883
Anterograde amnesia 33.48 10.38 14 90729 145 29483639
Joint dislocation 33.45 10.38 45 90698 3144 29480640
White blood cell count decreased 33.32 10.38 137 90606 83225 29400559
Pyrexia 33.12 10.38 653 90090 286969 29196815
Analgesic drug level increased 32.22 10.38 21 90722 571 29483213
Drug ineffective 31.10 10.38 863 89880 362307 29121477
Parasomnia 30.19 10.38 17 90726 352 29483432
Hyperacusis 29.97 10.38 22 90721 728 29483056
Oedematous pancreatitis 29.64 10.38 18 90725 431 29483353
Cough 29.41 10.38 248 90495 126479 29357305
Alanine aminotransferase increased 28.72 10.38 116 90627 70828 29412956
Inadequate analgesia 28.68 10.38 38 90705 2616 29481168
Apnoea 28.61 10.38 60 90683 6042 29477742
Platelet count decreased 28.46 10.38 196 90547 104476 29379308
Narcotic bowel syndrome 28.31 10.38 12 90731 129 29483655
Haemoglobin decreased 27.97 10.38 206 90537 108169 29375615
Myocardial fibrosis 27.07 10.38 24 90719 1044 29482740
Therapeutic response delayed 26.99 10.38 17 90726 435 29483349
Euphoric mood 26.89 10.38 51 90692 4774 29479010
Agitation 26.45 10.38 257 90486 51047 29432737
Negative pressure pulmonary oedema 25.96 10.38 13 90730 210 29483574
Hallucination, visual 25.96 10.38 103 90640 14912 29468872
Vomiting 25.74 10.38 842 89901 211418 29272366
Accidental overdose 25.22 10.38 114 90629 17479 29466305
Neutrophil count decreased 24.85 10.38 61 90682 43506 29440278
Foetal disorder 24.79 10.38 20 90723 763 29483021
Hyperhidrosis 24.39 10.38 304 90439 64236 29419548
Hypoosmolar state 24.23 10.38 9 90734 66 29483718
Urinary retention 24.02 10.38 174 90569 31724 29452060
Behaviour disorder 23.69 10.38 41 90702 3575 29480209
Tonic convulsion 23.65 10.38 21 90722 915 29482869
Pneumonia aspiration 23.55 10.38 193 90550 36544 29447240
Respiratory acidosis 23.21 10.38 45 90698 4283 29479501
Anal haemorrhage 22.62 10.38 29 90714 1933 29481851
Pneumonia 22.44 10.38 781 89962 319391 29164393
Suicidal behaviour 22.09 10.38 24 90719 1341 29482443
Body mass index abnormal 22.04 10.38 10 90733 128 29483656
Neuroleptic malignant syndrome 22 10.38 11 90732 16137 29467647
Hyper IgE syndrome 21.98 10.38 8 90735 55 29483729
Mucosal inflammation 21.55 10.38 40 90703 31555 29452229
Neutropenia neonatal 21.26 10.38 17 90726 640 29483144
Drug screen positive 20.97 10.38 40 90703 3761 29480023
Palmoplantar pustulosis 20.89 10.38 9 90734 101 29483683
Puncture site haematoma 20.87 10.38 10 90733 146 29483638
Adrenergic syndrome 20.62 10.38 8 90735 67 29483717
Hallucinations, mixed 20.60 10.38 31 90712 2402 29481382
Drug withdrawal syndrome neonatal 20.32 10.38 37 90706 3358 29480426
Altered state of consciousness 20.20 10.38 117 90626 19772 29464012
Cytomegalovirus infection 20.07 10.38 25 90718 23190 29460594
Graft versus host disease 19.68 10.38 3 90740 9625 29474159
Spinal operation 19.37 10.38 30 90713 2384 29481400
Discoloured vomit 19.37 10.38 14 90729 452 29483332
Hepatic function abnormal 19.37 10.38 59 90684 39200 29444584
Product communication issue 19.19 10.38 9 90734 125 29483659
Decompression sickness 19.16 10.38 4 90739 0 29483784
Insomnia 18.99 10.38 380 90363 88381 29395403
Fall 18.26 10.38 690 90053 176488 29307296
Stoma site pain 18.03 10.38 14 90729 505 29483279
Urethral valves 17.80 10.38 11 90732 272 29483512
Leukopenia 17.78 10.38 98 90645 55105 29428679
Logorrhoea 17.76 10.38 28 90715 2260 29481524
Bone marrow failure 17.64 10.38 36 90707 27413 29456371
Pulmonary oedema 17.32 10.38 204 90539 42531 29441253
Hyperaesthesia 17.31 10.38 35 90708 3434 29480350
Dehydration 17.23 10.38 248 90495 114500 29369284
Product substitution 17.17 10.38 6 90737 36 29483748
Myelosuppression 17.16 10.38 8 90735 12219 29471565
Haematocrit decreased 17.05 10.38 40 90703 28982 29454802
Change of bowel habit 17.01 10.38 18 90725 976 29482808
Sepsis 16.95 10.38 322 90421 142360 29341424
Hypopnoea 16.82 10.38 20 90723 1234 29482550
Cardiac failure congestive 16.37 10.38 153 90590 76428 29407356
Drug reaction with eosinophilia and systemic symptoms 16.32 10.38 144 90599 27848 29455936
Acute cutaneous lupus erythematosus 16.21 10.38 7 90736 79 29483705
Drug diversion 16.20 10.38 16 90727 799 29482985
Arteriovenous fistula 16.19 10.38 15 90728 691 29483093
Minimum inhibitory concentration 16.15 10.38 6 90737 44 29483740
Gastric bypass 15.87 10.38 10 90733 256 29483528
Anaemia 15.74 10.38 483 90260 200468 29283316
Blood creatinine increased 15.73 10.38 176 90567 84926 29398858
Wheezing 15.66 10.38 51 90692 33189 29450595
Lumbar radiculopathy 15.58 10.38 15 90728 726 29483058
Dyspnoea 15.37 10.38 833 89910 325899 29157885
Respiratory rate decreased 15.37 10.38 24 90719 1921 29481863
Neuralgia 15.24 10.38 70 90673 10804 29472980
Ligament calcification 14.99 10.38 9 90734 211 29483573
Physical deconditioning 14.91 10.38 15 90728 766 29483018
Road traffic accident 14.81 10.38 90 90653 15471 29468313
Haemorrhagic fever 14.75 10.38 5 90738 27 29483757
Aspartate aminotransferase increased 14.70 10.38 115 90628 59610 29424174
Haemophagocytic lymphohistiocytosis 14.54 10.38 7 90736 10497 29473287
Epilepsy with myoclonic-atonic seizures 14.37 10.38 3 90740 0 29483784
Femoral artery aneurysm 14.36 10.38 8 90735 162 29483622
Social anxiety disorder 14.30 10.38 9 90734 230 29483554
Back pain 14.29 10.38 413 90330 101871 29381913
Death 14.23 10.38 1226 89517 340858 29142926
Multiple organ dysfunction syndrome 13.96 10.38 125 90618 62991 29420793
Aplastic anaemia 13.93 10.38 3 90740 7507 29476277
Restless legs syndrome 13.80 10.38 50 90693 6934 29476850
Theft 13.73 10.38 9 90734 247 29483537
Drug interaction 13.61 10.38 738 90005 196647 29287137
Eosinophilic fasciitis 13.35 10.38 6 90737 75 29483709
Influenza virus test positive 13.21 10.38 6 90737 77 29483707
Renal impairment 13.20 10.38 173 90570 81160 29402624
Poor feeding infant 13.12 10.38 11 90732 443 29483341
Abnormal sleep-related event 13.08 10.38 11 90732 445 29483339
Substance use disorder 13.06 10.38 9 90734 269 29483515
Rash 13.03 10.38 464 90279 189355 29294429
Transplant rejection 12.97 10.38 6 90737 9206 29474578
Cerebral infarction 12.96 10.38 36 90707 24639 29459145
Substance abuser 12.88 10.38 6 90737 82 29483702
Nightmare 12.81 10.38 69 90674 11348 29472436
Nausea 12.70 10.38 1041 89702 288214 29195570
Facial pain 12.53 10.38 21 90722 1784 29482000
Tender joint count increased 12.48 10.38 5 90738 46 29483738
Therapeutic drug monitoring analysis not performed 12.40 10.38 11 90732 479 29483305
Hydroxyprolinuria 12.30 10.38 3 90740 3 29483781
Victim of sexual abuse 12.30 10.38 3 90740 3 29483781
Central-alveolar hypoventilation 12.30 10.38 3 90740 3 29483781
Capillary fragility 12.29 10.38 5 90738 48 29483736
Weaning failure 12.29 10.38 8 90735 217 29483567
Spleen congestion 12.20 10.38 9 90734 300 29483484
Arterial spasm 12.15 10.38 6 90737 94 29483690
Osteoarthritis 12.08 10.38 96 90647 18007 29465777
Tongue biting 12.06 10.38 13 90730 720 29483064
Vascular purpura 12.06 10.38 18 90725 1385 29482399
Inflammation 12.05 10.38 33 90710 22695 29461089
Blood urea increased 11.99 10.38 45 90698 28067 29455717
Appendicitis 11.93 10.38 6 90737 8773 29475011
Ichthyosis 11.92 10.38 6 90737 98 29483686
Aspergillus infection 11.92 10.38 9 90734 10572 29473212
Product administration error 11.91 10.38 80 90663 14230 29469554
Torsade de pointes 11.68 10.38 3 90740 6658 29477126
Sweat gland disorder 11.66 10.38 6 90737 103 29483681
Trigeminal neuralgia 11.61 10.38 15 90728 1007 29482777
Myocardial infarction 11.57 10.38 254 90489 110042 29373742
Pre-existing condition improved 11.56 10.38 23 90720 2230 29481554
Lentigo maligna 11.56 10.38 9 90734 326 29483458
Congenital heart valve disorder 11.54 10.38 5 90738 57 29483727
Spinal disorder 11.52 10.38 31 90712 3664 29480120
Toxic epidermal necrolysis 11.50 10.38 24 90719 18129 29465655
Schizophrenia 11.43 10.38 3 90740 6562 29477222
Otospondylomegaepiphyseal dysplasia 11.40 10.38 6 90737 108 29483676
Exposure during pregnancy 11.39 10.38 6 90737 8548 29475236
White blood cell count increased 11.33 10.38 68 90675 37448 29446336
Blood glucose increased 11.29 10.38 121 90622 58863 29424921
Emotional disorder 11.22 10.38 37 90706 4894 29478890
Interstitial lung disease 11.21 10.38 118 90625 57600 29426184
Impaired reasoning 11.16 10.38 6 90737 113 29483671
Nerve injury 11.16 10.38 27 90716 2990 29480794
Acidosis 11.13 10.38 59 90684 9646 29474138
Accidental exposure to product by child 11.11 10.38 17 90726 1337 29482447
Central nervous system stimulation 11.09 10.38 3 90740 6 29483778
Dyschezia 11.06 10.38 16 90727 1197 29482587
Limb fracture 11.05 10.38 4 90739 27 29483757
Hyperinsulinaemia 10.89 10.38 5 90738 66 29483718
Electric shock 10.88 10.38 6 90737 119 29483665
Blood lactate dehydrogenase increased 10.87 10.38 27 90716 19182 29464602
Haematuria 10.85 10.38 85 90658 44054 29439730
Trigger finger 10.85 10.38 12 90731 684 29483100
Product appearance confusion 10.81 10.38 4 90739 29 29483755
Glutathione decreased 10.78 10.38 3 90740 7 29483777
Inappropriate schedule of product administration 10.77 10.38 86 90657 44386 29439398
Neutropenia 10.69 10.38 315 90428 131396 29352388
Arthrofibrosis 10.62 10.38 5 90738 70 29483714
Spinal column injury 10.61 10.38 10 90733 471 29483313
Wrong technique in product usage process 10.56 10.38 55 90688 31373 29452411
Cerebral haemorrhage 10.56 10.38 55 90688 31371 29452413
Haemodialysis 10.55 10.38 9 90734 9945 29473839
Ventricular hypoplasia 10.50 10.38 5 90738 72 29483712
Aggression 10.40 10.38 160 90583 35381 29448403

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 941.10 9.53 1709 232807 130665 64133551
Drug dependence 940.16 9.53 856 233660 32456 64231760
Serotonin syndrome 934.10 9.53 918 233598 38364 64225852
Toxicity to various agents 800.91 9.53 3017 231499 360496 63903720
Poisoning deliberate 674.49 9.53 484 234032 12974 64251242
Coma 473.85 9.53 1009 233507 86606 64177610
Overdose 438.10 9.53 1426 233090 158140 64106076
Intentional overdose 412.53 9.53 970 233546 88974 64175242
Withdrawal syndrome 360.40 9.53 436 234080 23056 64241160
Completed suicide 335.71 9.53 1659 232857 222755 64041461
Somnolence 322.94 9.53 1531 232985 202114 64062102
Drug use disorder 310.85 9.53 221 234295 5833 64258383
Miosis 304.02 9.53 304 234212 12962 64251254
Intentional product misuse 301.80 9.53 752 233764 71543 64192673
Bradypnoea 245.85 9.53 180 234336 4979 64259237
Drug hypersensitivity 233.40 9.53 1572 232944 236243 64027973
Respiratory depression 232.59 9.53 352 234164 23091 64241125
Off label use 208.08 9.53 1398 233118 631408 63632808
Drug withdrawal syndrome 201.93 9.53 388 234128 30903 64233313
Prescription form tampering 199.39 9.53 68 234448 306 64263910
Mydriasis 193.39 9.53 258 234258 15054 64249162
Suicide attempt 178.99 9.53 617 233899 70390 64193826
Treatment failure 163.66 9.53 112 234404 116704 64147512
Anti-cyclic citrullinated peptide antibody positive 157.35 9.53 5 234511 49557 64214659
Hepatocellular injury 149.80 9.53 432 234084 44803 64219413
Confusional state 149.20 9.53 1528 232988 259616 64004600
Hand deformity 143.69 9.53 27 234489 62744 64201472
Glossodynia 129.88 9.53 37 234479 64659 64199557
Infusion related reaction 129.35 9.53 251 234265 164216 64100000
Drug abuser 125.59 9.53 129 234387 5679 64258537
Prescription drug used without a prescription 124.53 9.53 91 234425 2509 64261707
Drug interaction 124.45 9.53 1927 232589 360156 63904060
Generalised tonic-clonic seizure 119.97 9.53 368 234148 39489 64224727
Synovitis 117.56 9.53 112 234404 98978 64165238
Asphyxia 109.94 9.53 154 234362 9412 64254804
Contraindicated product administered 109.06 9.53 139 234377 107690 64156526
Seizure 108.69 9.53 1004 233512 165888 64098328
Drug ineffective 107.72 9.53 2285 232231 837962 63426254
Maternal exposure during pregnancy 101.83 9.53 119 234397 95765 64168451
Pericarditis 100.16 9.53 51 234465 62465 64201751
Joint swelling 97.42 9.53 427 234089 214955 64049261
Systemic lupus erythematosus 95.28 9.53 85 234431 77527 64186689
Helicobacter infection 91.07 9.53 15 234501 38347 64225869
Drug intolerance 86.04 9.53 371 234145 187621 64076595
Duodenal ulcer perforation 85.72 9.53 12 234504 34613 64229603
Cholestasis 85.00 9.53 356 234160 44516 64219700
Therapeutic product effect decreased 83.11 9.53 185 234331 115166 64149050
Hallucination, visual 80.98 9.53 254 234262 27580 64236636
Rheumatoid factor positive 80.02 9.53 15 234501 34923 64229293
Gastrointestinal pain 78.36 9.53 116 234400 7458 64256758
Fall 76.76 9.53 2021 232495 414805 63849411
Poisoning 74.41 9.53 211 234305 21668 64242548
Derealisation 73.14 9.53 53 234463 1442 64262774
Hallucination 72.93 9.53 484 234032 72304 64191912
Wound 71.85 9.53 104 234412 76373 64187843
Hyperacusis 71.13 9.53 58 234458 1887 64262329
Hepatic enzyme increased 70.71 9.53 239 234277 129704 64134512
Drug resistance 70.59 9.53 20 234496 35082 64229134
Sensitisation 70.53 9.53 55 234461 1676 64262540
Rash 69.19 9.53 1212 233304 457337 63806879
Myoclonus 67.44 9.53 223 234293 24895 64239321
Analgesic drug level increased 67.28 9.53 60 234456 2210 64262006
Febrile neutropenia 66.75 9.53 404 234112 187253 64076963
Deafness transitory 66.71 9.53 40 234476 783 64263433
Vomiting 66.69 9.53 2540 231976 548577 63715639
Dependence 65.94 9.53 58 234458 2097 64262119
Product use in unapproved indication 65.07 9.53 376 234140 176242 64087974
Respiratory acidosis 64.55 9.53 123 234393 9732 64254484
Polycystic ovaries 63.95 9.53 57 234459 2098 64262118
Pyrexia 62.90 9.53 1549 232967 557095 63707121
Loss of consciousness 62.58 9.53 819 233697 147546 64116670
Constipation 61.40 9.53 1173 233343 228164 64036052
Wrong patient received product 61.27 9.53 72 234444 3690 64260526
Hyperhidrosis 59.73 9.53 706 233810 124214 64140002
Depressed level of consciousness 59.73 9.53 503 234013 80933 64183283
Ejection fraction 59.32 9.53 44 234472 1242 64262974
Muscle injury 59.17 9.53 12 234504 26425 64237791
Folliculitis 58.90 9.53 18 234498 30059 64234157
Agitation 56.66 9.53 530 233986 87837 64176379
Epilepsy 56.61 9.53 257 234259 33274 64230942
Depersonalisation/derealisation disorder 56.00 9.53 47 234469 1593 64262623
Disorientation 55.78 9.53 371 234145 55457 64208759
Alopecia 52.68 9.53 369 234147 165321 64098895
Clonus 50.38 9.53 84 234432 5983 64258233
Cytomegalovirus infection 50.31 9.53 37 234479 37162 64227054
Gastric pH decreased 50.12 9.53 32 234484 703 64263513
Hypersensitivity 49.82 9.53 465 234051 195987 64068229
Hypoglycaemia 49.32 9.53 522 233994 89370 64174846
Sleep disorder due to general medical condition, insomnia type 49.19 9.53 17 234499 26253 64237963
Apnoea 48.37 9.53 113 234403 10309 64253907
Drug diversion 48.26 9.53 37 234479 1099 64263117
Death 48.11 9.53 2180 232336 480525 63783691
Hepatic function abnormal 48.09 9.53 101 234415 64212 64200004
Hallucinations, mixed 47.88 9.53 82 234434 5970 64258246
Exposure during pregnancy 47.82 9.53 135 234381 77540 64186676
Behaviour disorder 47.12 9.53 69 234447 4393 64259823
Discomfort 45.89 9.53 146 234370 80732 64183484
Ankylosing spondylitis 45.81 9.53 96 234420 8138 64256078
Platelet count decreased 45.58 9.53 390 234126 167321 64096895
Pneumonia 44.68 9.53 1625 232891 557951 63706265
Nausea 44.57 9.53 3373 231143 782427 63481789
Device expulsion 44.48 9.53 11 234505 21125 64243091
Housebound 44.04 9.53 25 234491 440 64263776
Leukopenia 43.76 9.53 204 234312 101038 64163178
Accidental overdose 43.73 9.53 239 234277 33318 64230898
Urinary retention 42.72 9.53 316 234200 48885 64215331
Shoulder arthroplasty 42.72 9.53 51 234465 2658 64261558
C-reactive protein increased 42.35 9.53 189 234327 94720 64169496
Depression 42.24 9.53 917 233599 182374 64081842
Sacroiliitis 41.53 9.53 53 234463 2959 64261257
Vertigo 41.43 9.53 361 234155 58650 64205566
Cardio-respiratory arrest 41.40 9.53 543 233973 97850 64166366
Decorticate posture 41.11 9.53 21 234495 296 64263920
Myelosuppression 40.37 9.53 18 234498 23812 64240404
Blood creatinine increased 39.98 9.53 309 234207 135473 64128743
Renal impairment 39.88 9.53 307 234209 134710 64129506
Myocardial depression 39.61 9.53 24 234492 479 64263737
Mycotic allergy 39.13 9.53 31 234485 967 64263249
Delirium 38.51 9.53 403 234113 68791 64195425
Multiple drug therapy 38.15 9.53 44 234472 2210 64262006
Haemoglobin decreased 37.41 9.53 492 234024 194571 64069645
Red blood cell sedimentation rate increased 37.39 9.53 35 234481 31200 64233016
Tonic clonic movements 37.37 9.53 41 234475 1948 64262268
Rhinitis allergic 36.85 9.53 87 234429 7991 64256225
Neutropenia 36.80 9.53 631 233885 238993 64025223
Transplant rejection 36.72 9.53 9 234507 17392 64246824
Sphincter of Oddi dysfunction 36.19 9.53 21 234495 386 64263830
Bone marrow failure 35.27 9.53 76 234440 47876 64216340
Disturbance in attention 35.20 9.53 263 234253 40811 64223405
Impaired healing 35.12 9.53 108 234408 60365 64203851
Rheumatoid nodule 34.81 9.53 3 234513 12648 64251568
Euphoric mood 34.54 9.53 75 234441 6516 64257700
Disease progression 34.36 9.53 339 234177 141341 64122875
Feeling of despair 33.55 9.53 44 234472 2524 64261692
Drug detoxification 33.44 9.53 17 234499 237 64263979
Functional gastrointestinal disorder 32.72 9.53 56 234460 4075 64260141
Carpal tunnel syndrome 32.68 9.53 129 234387 15699 64248517
Drug dispensed to wrong patient 32.32 9.53 19 234497 358 64263858
Multiple organ dysfunction syndrome 32.14 9.53 226 234290 101187 64163029
Antimicrobial susceptibility test resistant 31.71 9.53 17 234499 266 64263950
Premature delivery 31.55 9.53 14 234502 18575 64245641
Wrong technique in product usage process 31.07 9.53 126 234390 64848 64199368
Dissociation 30.98 9.53 46 234470 2965 64261251
Somatic symptom disorder 30.83 9.53 36 234480 1832 64262384
Suicidal ideation 30.44 9.53 373 234143 66169 64198047
Feeding disorder 30.44 9.53 110 234406 12839 64251377
Cough 30.40 9.53 851 233665 301297 63962919
Abdominal discomfort 30.33 9.53 473 234043 181849 64082367
Infection 29.96 9.53 482 234034 184398 64079818
White blood cell count decreased 29.93 9.53 399 234117 157438 64106778
Hyponatraemia 29.78 9.53 728 233788 147611 64116605
Sleep apnoea syndrome 29.64 9.53 198 234318 29634 64234582
Fibromyalgia 29.62 9.53 227 234289 35504 64228712
Pathogen resistance 29.56 9.53 5 234511 12538 64251678
Dizziness 29.43 9.53 1876 232640 428287 63835929
Pancreatic fibrosis 29.32 9.53 12 234504 97 64264119
Psychotic disorder due to a general medical condition 29.04 9.53 16 234500 265 64263951
Visceral congestion 28.99 9.53 24 234492 798 64263418
Cerebral infarction 28.59 9.53 67 234449 40977 64223239
Mixed anxiety and depressive disorder 28.20 9.53 14 234502 185 64264031
Neutrophil count decreased 28.05 9.53 165 234351 77031 64187185
Interstitial lung disease 28.02 9.53 224 234292 97508 64166708
Unresponsive to stimuli 27.80 9.53 293 234223 50100 64214116
Abnormal loss of weight 27.78 9.53 74 234442 7326 64256890
Parasomnia 27.58 9.53 19 234497 476 64263740
Burning sensation 27.51 9.53 289 234227 49375 64214841
Epstein-Barr virus infection 27.27 9.53 6 234510 12482 64251734
Chronic kidney disease 26.64 9.53 325 234191 57594 64206622
Feeling of body temperature change 26.63 9.53 56 234460 4758 64259458
Disease recurrence 26.60 9.53 46 234470 31464 64232752
Anxiety 26.57 9.53 943 233573 201706 64062510
Cestode infection 26.47 9.53 15 234501 263 64263953
Nightmare 26.34 9.53 148 234368 20845 64243371
Cytomegalovirus viraemia 26.23 9.53 4 234512 10824 64253392
Muscle spasms 26.21 9.53 685 233831 140338 64123878
Peripheral circulatory failure 26.10 9.53 21 234495 670 64263546
Thrombotic microangiopathy 26.06 9.53 14 234502 16641 64247575
Restless legs syndrome 25.83 9.53 127 234389 16989 64247227
Inadequate analgesia 25.25 9.53 49 234467 3929 64260287
Cyanosis 25.08 9.53 152 234364 22003 64242213
Pituitary tumour benign 25.00 9.53 36 234480 2257 64261959
Eosinophil count increased 24.96 9.53 10 234506 14102 64250114
Neuralgia 24.95 9.53 172 234344 26012 64238204
Hyperkalaemia 24.92 9.53 241 234275 100888 64163328
Central nervous system stimulation 24.82 9.53 8 234508 29 64264187
Cardiac failure congestive 24.79 9.53 330 234186 130250 64133966
Blood test abnormal 24.75 9.53 103 234413 12840 64251376
Alanine aminotransferase increased 24.73 9.53 356 234160 138675 64125541
Abdominal pain upper 24.58 9.53 821 233695 174209 64090007
Speech disorder 24.58 9.53 277 234239 48164 64216052
Road traffic accident 24.20 9.53 193 234323 30552 64233664
Altered state of consciousness 24.12 9.53 227 234289 37675 64226541
Intentional product use issue 24.04 9.53 226 234290 95138 64169078
Suicidal behaviour 24.01 9.53 40 234476 2847 64261369
Arthropathy 23.96 9.53 303 234213 120664 64143552
Aspergillus infection 23.88 9.53 15 234501 16364 64247852
Stomatitis 23.83 9.53 269 234247 109336 64154880
Heart rate decreased 23.76 9.53 111 234405 54956 64209260
Negative pressure pulmonary oedema 23.67 9.53 13 234503 214 64264002
Pneumocystis jirovecii pneumonia 23.64 9.53 40 234476 27594 64236622
Gait disturbance 23.53 9.53 805 233711 171350 64092866
Acute motor-sensory axonal neuropathy 23.39 9.53 16 234500 396 64263820
Fracture 23.38 9.53 132 234384 18623 64245593
Septic shock 23.22 9.53 258 234258 105179 64159037
Haemophagocytic lymphohistiocytosis 23.19 9.53 18 234498 17591 64246625
Amnesia 23.14 9.53 273 234243 47996 64216220
Haemodialysis 23.07 9.53 17 234499 17060 64247156
Analgesic drug level above therapeutic 22.64 9.53 16 234500 418 64263798
Respiratory arrest 22.52 9.53 293 234223 52692 64211524
Haematocrit decreased 22.52 9.53 112 234404 54543 64209673
H1N1 influenza 22.43 9.53 34 234482 2232 64261984
Narcotic bowel syndrome 22.30 9.53 13 234503 241 64263975
Parosmia 22.29 9.53 51 234465 4589 64259627
Blood pressure increased 22.28 9.53 468 234048 172084 64092132
Drug eruption 22.09 9.53 63 234453 36073 64228143
Mucosal inflammation 22.09 9.53 135 234381 62449 64201767
Nephropathy toxic 21.71 9.53 19 234497 17495 64246721
Caesarean section 21.62 9.53 7 234509 11267 64252949
Inappropriate antidiuretic hormone secretion 21.58 9.53 147 234369 22142 64242074
Body mass index abnormal 21.35 9.53 12 234504 207 64264009
Thrombocytopenia 21.32 9.53 635 233881 223166 64041050
Insomnia 21.29 9.53 901 233615 196935 64067281
Graft versus host disease 21.05 9.53 12 234504 13801 64250415
Tinnitus 21.01 9.53 203 234313 33930 64230286
Congenital central hypoventilation syndrome 20.99 9.53 7 234509 29 64264187
Coma scale abnormal 20.85 9.53 69 234447 7705 64256511
Faecaloma 20.67 9.53 80 234436 9648 64254568
Hyperreflexia 20.58 9.53 65 234451 7083 64257133
Psychomotor skills impaired 20.43 9.53 44 234472 3801 64260415
Therapy non-responder 20.32 9.53 148 234368 65751 64198465
Drug screen positive 20.21 9.53 56 234460 5673 64258543
Irritable bowel syndrome 20.13 9.53 69 234447 37300 64226916
Persistent genital arousal disorder 20.10 9.53 12 234504 233 64263983
Abortion spontaneous 20.07 9.53 38 234478 25105 64239111
Intervertebral disc protrusion 20.05 9.53 134 234382 20057 64244159
Pregnancy 19.96 9.53 28 234488 20837 64243379
Vasoplegia syndrome 19.96 9.53 36 234480 2731 64261485
Creatinine renal clearance decreased 19.95 9.53 14 234502 14407 64249809
Oedematous pancreatitis 19.70 9.53 20 234496 868 64263348
Menstrual disorder 19.62 9.53 40 234476 3325 64260891
Myocardial infarction 19.61 9.53 456 234060 165365 64098851
Pancytopenia 19.59 9.53 385 234131 142924 64121292
Anaemia 19.56 9.53 1152 233364 377528 63886688
Erythema 19.54 9.53 524 233992 186546 64077670
Tremor 19.47 9.53 690 233826 147540 64116676
Limb injury 19.30 9.53 149 234367 23356 64240860
Feeling drunk 19.14 9.53 45 234471 4122 64260094
Lower respiratory tract infection 19.10 9.53 236 234280 94378 64169838
Secondary adrenocortical insufficiency 18.85 9.53 32 234484 2313 64261903
Accidental exposure to product by child 18.78 9.53 33 234483 2452 64261764
Snoring 18.78 9.53 48 234468 4634 64259582
Back pain 18.74 9.53 1100 233416 249071 64015145
Foot operation 18.66 9.53 45 234471 4190 64260026
Pancreatitis acute 18.64 9.53 238 234278 42617 64221599
Emotional disorder 18.64 9.53 93 234423 12514 64251702
Product use issue 18.56 9.53 415 234101 151300 64112916
Obstructive airways disorder 18.54 9.53 35 234481 23150 64241066
Ex-drug abuser 18.48 9.53 4 234512 0 64264216
Decompression sickness 18.48 9.53 4 234512 0 64264216
Skin necrosis 18.43 9.53 15 234501 14314 64249902
Puncture site haematoma 18.40 9.53 10 234506 161 64264055
Dyspnoea 18.37 9.53 2311 232205 716363 63547853
Therapeutic product ineffective 18.35 9.53 25 234491 1488 64262728
Nasopharyngitis 18.26 9.53 558 233958 195515 64068701
Thymus disorder 18.22 9.53 11 234505 218 64263998
Live birth 18.15 9.53 9 234507 11195 64253021
Pseudomonas infection 18.12 9.53 23 234493 17860 64246356
Nephrectomy 18.01 9.53 24 234492 1398 64262818
Therapeutic response delayed 18.01 9.53 19 234497 863 64263353
Product substitution 17.99 9.53 8 234508 81 64264135
Respiratory disorder 17.92 9.53 69 234447 36042 64228174
Injection site reaction 17.89 9.53 98 234418 46566 64217650
Encephalopathy 17.87 9.53 307 234209 58512 64205704
Muscle tone disorder 17.86 9.53 9 234507 123 64264093
Premenstrual syndrome 17.86 9.53 15 234501 509 64263707
Device ineffective 17.73 9.53 9 234507 125 64264091
Type 2 diabetes mellitus 17.53 9.53 64 234452 33956 64230260
Mania 17.34 9.53 110 234406 16176 64248040
Disinhibition 17.23 9.53 30 234486 2213 64262003
Blood parathyroid hormone decreased 17.22 9.53 3 234513 7363 64256853
Bladder prolapse 17.21 9.53 21 234495 1120 64263096
Antidepressant drug level above therapeutic 17.18 9.53 15 234501 537 64263679
Urticaria 17.17 9.53 406 234110 146911 64117305
Vascular purpura 16.86 9.53 32 234484 2524 64261692
Accidental exposure to product 16.84 9.53 45 234471 26319 64237897
Feeling abnormal 16.83 9.53 619 233897 132983 64131233
Prothrombin time shortened 16.77 9.53 34 234482 2815 64261401
Deafness 16.56 9.53 119 234397 18240 64245976
Tachycardia 16.49 9.53 683 233833 148896 64115320
Bradycardia foetal 16.44 9.53 8 234508 101 64264115
Quality of life decreased 16.42 9.53 64 234452 7742 64256474
Hyperaesthesia 16.34 9.53 76 234440 9938 64254278
Renal tubular necrosis 16.29 9.53 35 234481 22075 64242141
Blood pressure fluctuation 16.23 9.53 116 234400 51755 64212461
Myelodysplastic syndrome 16.19 9.53 49 234467 27530 64236686
Blood calcium decreased 16.03 9.53 44 234472 25510 64238706
Progressive multifocal leukoencephalopathy 15.96 9.53 26 234490 18206 64246010
Hypertonia 15.96 9.53 55 234461 6270 64257946
Respiratory rate decreased 15.95 9.53 44 234472 4447 64259769
Disseminated intravascular coagulation 15.93 9.53 62 234454 32286 64231930
Mixed liver injury 15.92 9.53 50 234466 5431 64258785
Cushingoid 15.91 9.53 4 234512 7599 64256617
Hyperlipasaemia 15.90 9.53 19 234497 991 64263225
Polymenorrhoea 15.80 9.53 18 234498 892 64263324
Blood pressure systolic increased 15.76 9.53 110 234406 49343 64214873
Substance use disorder 15.69 9.53 12 234504 355 64263861
Minimum inhibitory concentration 15.65 9.53 6 234510 40 64264176
Acute generalised exanthematous pustulosis 15.63 9.53 96 234420 13962 64250254
Cogwheel rigidity 15.56 9.53 33 234483 2820 64261396
Tonic convulsion 15.56 9.53 26 234490 1855 64262361
Growth disorder 15.54 9.53 5 234511 18 64264198
Adrenergic syndrome 15.52 9.53 8 234508 115 64264101
Swelling 15.40 9.53 454 234062 159764 64104452
Headache 15.32 9.53 2172 232344 527295 63736921
BK virus infection 15.32 9.53 4 234512 7408 64256808
Hypothermia 15.27 9.53 124 234392 19732 64244484
Neck pain 15.17 9.53 311 234205 61222 64202994
Joint dislocation 15.17 9.53 82 234434 11383 64252833
Cystitis haemorrhagic 15.15 9.53 5 234511 7951 64256265
Cardiac failure 15.10 9.53 366 234150 132007 64132209
Bronchopulmonary aspergillosis 15.09 9.53 29 234487 19056 64245160
Magnesium deficiency 14.97 9.53 14 234502 549 64263667
Gallbladder cholesterolosis 14.97 9.53 14 234502 549 64263667
Hypoventilation 14.96 9.53 52 234464 5954 64258262
Lactic acidosis 14.85 9.53 147 234369 61263 64202953
Performance enhancing product use 14.84 9.53 7 234509 82 64264134
Therapeutic response decreased 14.78 9.53 120 234396 52068 64212148
Lymphopenia 14.77 9.53 46 234470 25611 64238605
Accidental death 14.75 9.53 38 234478 3687 64260529
Weight increased 14.68 9.53 630 233886 212718 64051498
Listless 14.54 9.53 35 234481 3255 64260961
Haemorrhage 14.52 9.53 202 234314 79149 64185067
Muscle rigidity 14.47 9.53 111 234405 17362 64246854
Sleep disorder 14.47 9.53 301 234215 59408 64204808
Metastases to liver 14.44 9.53 42 234474 23899 64240317
Swollen joint count increased 14.35 9.53 5 234511 7684 64256532
Ascites 14.34 9.53 150 234366 61851 64202365
Back disorder 14.28 9.53 73 234443 9917 64254299
Muscle disorder 14.23 9.53 45 234471 4906 64259310
Anal haemorrhage 14.19 9.53 35 234481 3305 64260911
Abdominal pain lower 14.18 9.53 153 234363 26316 64237900
Pharyngitis 14.16 9.53 118 234398 18921 64245295
Hypoaesthesia oral 14.11 9.53 81 234435 11499 64252717
Gallbladder polyp 14.10 9.53 17 234499 895 64263321
C-reactive protein abnormal 14.09 9.53 56 234460 28991 64235225
Sepsis 14.07 9.53 689 233827 229652 64034564
Lip pruritus 14.07 9.53 15 234501 690 64263526
Substance abuse 14.06 9.53 69 234447 9223 64254993
Enterococcal infection 13.88 9.53 18 234498 13848 64250368
Trigger finger 13.87 9.53 36 234480 3509 64260707
Epilepsy with myoclonic-atonic seizures 13.86 9.53 3 234513 0 64264216
Electrocution 13.86 9.53 3 234513 0 64264216
Surgery 13.71 9.53 160 234356 28053 64236163
Dehydration 13.71 9.53 646 233870 216117 64048099
Haemolysis 13.65 9.53 12 234504 11027 64253189
Wrong rate 13.64 9.53 6 234510 59 64264157
Ligament calcification 13.55 9.53 9 234507 212 64264004
Depressed mood 13.54 9.53 217 234299 40795 64223421
Blood pressure decreased 13.53 9.53 226 234290 85973 64178243
Anterograde amnesia 13.45 9.53 14 234502 626 64263590
Drug level below therapeutic 13.45 9.53 5 234511 7379 64256837
Second primary malignancy 13.43 9.53 15 234501 12322 64251894
Tenosynovitis 13.31 9.53 14 234502 11819 64252397
Rectal prolapse 13.15 9.53 23 234493 1703 64262513
Pneumonia aspiration 13.15 9.53 295 234221 58976 64205240
Hypopnoea 13.08 9.53 33 234483 3161 64261055
Immunosuppressant drug level increased 13.08 9.53 5 234511 7254 64256962
Ill-defined disorder 13.07 9.53 100 234416 43952 64220264
Arthrofibrosis 12.97 9.53 7 234509 111 64264105
Gastrooesophageal reflux disease 12.97 9.53 395 234121 82748 64181468
Aspartate aminotransferase increased 12.91 9.53 334 234182 119454 64144762
Thermal burn 12.90 9.53 49 234467 5857 64258359
Lumbar radiculopathy 12.85 9.53 23 234493 1734 64262482
Musculoskeletal disorder 12.80 9.53 110 234406 17796 64246420
Pulmonary alveolar haemorrhage 12.77 9.53 10 234506 9728 64254488
Dermatitis bullous 12.75 9.53 15 234501 12039 64252177
Lichen sclerosus 12.71 9.53 16 234500 881 64263335
Muscle twitching 12.70 9.53 115 234401 18883 64245333
Immune reconstitution inflammatory syndrome 12.68 9.53 16 234500 12454 64251762
Spinal operation 12.67 9.53 50 234466 6083 64258133
Sinus congestion 12.62 9.53 23 234493 15416 64248800
Diabetes mellitus 12.60 9.53 168 234348 66306 64197910
Fear of injection 12.59 9.53 3 234513 5909 64258307
Arteriovenous fistula 12.58 9.53 16 234500 890 64263326
Victim of sexual abuse 12.55 9.53 11 234505 396 64263820
Allergy test negative 12.52 9.53 4 234512 14 64264202
Drug level decreased 12.50 9.53 14 234502 11489 64252727
Hyperthermia 12.45 9.53 98 234418 15452 64248764
Labelled drug-drug interaction issue 12.43 9.53 11 234505 401 64263815
Rotator cuff syndrome 12.42 9.53 81 234435 12026 64252190
Ear infection 12.40 9.53 135 234381 23269 64240947
Decreased immune responsiveness 12.40 9.53 40 234476 4408 64259808
Prothrombin level increased 12.38 9.53 11 234505 403 64263813
Bone lesion 12.38 9.53 44 234472 5093 64259123
Discoloured vomit 12.37 9.53 18 234498 1139 64263077
Menstruation delayed 12.35 9.53 18 234498 1141 64263075
Breast disorder 12.26 9.53 22 234494 1662 64262554
Coagulopathy 12.26 9.53 67 234449 31853 64232363
Facial pain 12.21 9.53 59 234457 7836 64256380
Manipulation 12.17 9.53 6 234510 78 64264138
Eyelid myoclonus 12.16 9.53 5 234511 41 64264175
Degenerative bone disease 12.16 9.53 5 234511 41 64264175
Femoral artery aneurysm 12.13 9.53 8 234508 186 64264030
Hypoosmolar state 12.10 9.53 9 234507 255 64263961
Appetite disorder 12.03 9.53 51 234465 6410 64257806
Anoxia 12.01 9.53 10 234506 335 64263881
Rheumatoid arthritis 11.97 9.53 482 234034 163812 64100404
Body temperature increased 11.96 9.53 81 234435 36585 64227631
Oedema 11.96 9.53 249 234267 91686 64172530
Coeliac disease 11.94 9.53 6 234510 7406 64256810
Purple glove syndrome 11.92 9.53 9 234507 261 64263955
Injection site pain 11.90 9.53 311 234205 111097 64153119
Hot flush 11.84 9.53 235 234281 46000 64218216
Thecal sac compression 11.79 9.53 3 234513 3 64264213
Delusion of parasitosis 11.79 9.53 3 234513 3 64264213
Panniculitis 11.79 9.53 9 234507 8870 64255346
Spleen congestion 11.77 9.53 11 234505 431 64263785
Therapeutic drug monitoring analysis not performed 11.74 9.53 18 234498 1194 64263022
Mucormycosis 11.74 9.53 6 234510 7335 64256881
Diastolic hypotension 11.72 9.53 7 234509 136 64264080
Mouth swelling 11.68 9.53 43 234473 5064 64259152
Cerebral haemorrhage 11.65 9.53 124 234392 50966 64213250
Pneumonia viral 11.63 9.53 7 234509 7815 64256401
Fluid retention 11.54 9.53 150 234366 59456 64204760
Wheezing 11.46 9.53 215 234301 80364 64183852
Flushing 11.45 9.53 209 234307 78439 64185777
Angioedema 11.45 9.53 157 234359 61664 64202552
Hepatitis 11.44 9.53 231 234285 45351 64218865
General physical health deterioration 11.43 9.53 617 233899 203808 64060408
Pulmonary hypertension 11.40 9.53 101 234415 43038 64221178
Dry mouth 11.37 9.53 294 234222 60124 64204092
Compulsive shopping 11.23 9.53 14 234502 763 64263453
Hyperglycaemia 11.23 9.53 155 234361 60813 64203403
Infective pulmonary exacerbation of cystic fibrosis 11.12 9.53 16 234500 11780 64252436
Blood bilirubin increased 11.08 9.53 145 234371 57408 64206808
Urogenital haemorrhage 11.05 9.53 13 234503 667 64263549
Tuberculosis 11.04 9.53 19 234497 13019 64251197
Neuroleptic malignant syndrome 11.01 9.53 50 234466 24946 64239270
Autoimmune haemolytic anaemia 10.99 9.53 6 234510 7070 64257146
Inflammation 10.98 9.53 169 234347 65131 64199085
Visual acuity reduced 10.96 9.53 56 234460 27085 64237131
Knee operation 10.96 9.53 39 234477 4518 64259698
Blood glucose increased 10.95 9.53 272 234244 97801 64166415
Multiple-drug resistance 10.87 9.53 5 234511 6497 64257719
Aggression 10.86 9.53 232 234284 46000 64218216
Blood lactate dehydrogenase increased 10.83 9.53 73 234443 33005 64231211
Sedation complication 10.83 9.53 13 234503 10341 64253875
Feeling jittery 10.81 9.53 71 234445 10564 64253652
Hypersensitivity vasculitis 10.80 9.53 51 234465 6710 64257506
Post cardiac arrest syndrome 10.79 9.53 4 234512 24 64264192
Central-alveolar hypoventilation 10.79 9.53 4 234512 24 64264192
Drug tolerance decreased 10.78 9.53 6 234510 6992 64257224
Lymphadenopathy 10.77 9.53 113 234403 46573 64217643
Burning mouth syndrome 10.73 9.53 11 234505 483 64263733
Prothrombin time prolonged 10.72 9.53 26 234490 15715 64248501
Acquired cystic kidney disease 10.72 9.53 5 234511 57 64264159
Theft 10.66 9.53 8 234508 230 64263986
Subileus 10.63 9.53 41 234475 4936 64259280
Foaming at mouth 10.62 9.53 21 234495 1708 64262508
Substance abuser 10.60 9.53 6 234510 105 64264111
Medication overuse headache 10.60 9.53 13 234503 697 64263519
Oropharyngeal neoplasm 10.59 9.53 3 234513 6 64264210
Anorgasmia 10.49 9.53 15 234501 934 64263282
Retinal toxicity 10.49 9.53 18 234498 1312 64262904
Frequent bowel movements 10.41 9.53 33 234483 18272 64245944
Peritoneal perforation 10.39 9.53 7 234509 169 64264047
Injection site erythema 10.35 9.53 188 234328 70612 64193604
Hydroxyprolinuria 10.28 9.53 3 234513 7 64264209
Generalised anxiety disorder 10.27 9.53 22 234494 1893 64262323
Bladder cancer 10.23 9.53 15 234501 10959 64253257
Vocal cord dysfunction 10.22 9.53 10 234506 415 64263801
Lymphoproliferative disorder 10.09 9.53 3 234513 5100 64259116
Oral lichenoid reaction 10.08 9.53 5 234511 66 64264150
Acidosis 10.06 9.53 104 234412 17691 64246525
Unintentional medical device removal 10.05 9.53 6 234510 6728 64257488
Encephalitis 10.03 9.53 19 234497 12552 64251664
Haematuria 10.00 9.53 157 234359 60314 64203902
Granulocytopenia 10.00 9.53 14 234502 10426 64253790
Lung neoplasm malignant 10.00 9.53 42 234474 21406 64242810
Pre-existing condition improved 9.98 9.53 39 234477 4723 64259493
Sinus bradycardia 9.96 9.53 46 234470 22847 64241369
Postictal paralysis 9.95 9.53 9 234507 338 64263878
Respiratory depth decreased 9.92 9.53 4 234512 31 64264185
Haemorrhagic fever 9.92 9.53 4 234512 31 64264185
Antibiotic therapy 9.91 9.53 13 234503 746 64263470
Pseudoporphyria 9.89 9.53 11 234505 531 64263685
Kidney transplant rejection 9.88 9.53 12 234504 9499 64254717
Postmortem blood drug level increased 9.88 9.53 13 234503 748 64263468
Tongue disorder 9.87 9.53 18 234498 12062 64252154
Organising pneumonia 9.87 9.53 11 234505 9044 64255172
Mood swings 9.84 9.53 102 234414 17366 64246850
Sensory loss 9.81 9.53 67 234449 10102 64254114
Joint injury 9.79 9.53 127 234389 22820 64241396
Bronchospasm 9.77 9.53 43 234473 21639 64242577
Inappropriate schedule of product administration 9.76 9.53 258 234258 92028 64172188
Cardiogenic shock 9.75 9.53 169 234347 32258 64231958
Social anxiety disorder 9.74 9.53 10 234506 440 64263776
VIIIth nerve injury 9.74 9.53 3 234513 9 64264207
Oral discomfort 9.72 9.53 58 234458 8348 64255868
Poor venous access 9.71 9.53 19 234497 12398 64251818
Limb fracture 9.70 9.53 4 234512 33 64264183
Resting tremor 9.70 9.53 18 234498 1396 64262820
Lip erosion 9.69 9.53 17 234499 1262 64262954
Sweat gland disorder 9.67 9.53 7 234509 190 64264026
Cardiotoxicity 9.62 9.53 14 234502 10260 64253956
Potentiating drug interaction 9.61 9.53 55 234461 7797 64256419
Ichthyosis 9.59 9.53 6 234510 127 64264089
Injection site swelling 9.58 9.53 100 234416 41253 64222963
Papilloedema 9.58 9.53 4 234512 5501 64258715
Bruxism 9.57 9.53 32 234484 3592 64260624

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
MeSH PA D000700 Analgesics
MeSH PA D000701 Analgesics, Opioid
MeSH PA D002491 Central Nervous System Agents
MeSH PA D002492 Central Nervous System Depressants
MeSH PA D009294 Narcotics
MeSH PA D018373 Peripheral Nervous System Agents
MeSH PA D018689 Sensory System Agents
CHEBI has role CHEBI:35482 narcotic analgesic
CHEBI has role CHEBI: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

Drug Use (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




๐Ÿถ Veterinary Drug Use

None

๐Ÿถ Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 9.01 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
100MG CONZIP CIPHER PHARMS INC N022370 May 7, 2010 RX CAPSULE, EXTENDED RELEASE ORAL 7858118 April 11, 2022 USE OF TRAMADOL FOR THE MANAGEMENT OF MODERATE TO MODERATELY SEVERE CHRONIC PAIN
200MG CONZIP CIPHER PHARMS INC N022370 May 7, 2010 RX CAPSULE, EXTENDED RELEASE ORAL 7858118 April 11, 2022 USE OF TRAMADOL FOR THE MANAGEMENT OF MODERATE TO MODERATELY SEVERE CHRONIC PAIN
300MG CONZIP CIPHER PHARMS INC N022370 May 7, 2010 RX CAPSULE, EXTENDED RELEASE ORAL 7858118 April 11, 2022 USE OF TRAMADOL FOR THE MANAGEMENT OF MODERATE TO MODERATELY SEVERE CHRONIC PAIN
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
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 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 13811-690 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 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
Tramadol Hydrochloride and Acetaminophen HUMAN PRESCRIPTION DRUG LABEL 2 21695-236 TABLET 37.50 mg ORAL ANDA 27 sections
ULTRAM ER HUMAN PRESCRIPTION DRUG LABEL 1 21695-292 TABLET, EXTENDED RELEASE 100 mg ORAL NDA 26 sections
ULTRAM ER HUMAN PRESCRIPTION DRUG LABEL 1 21695-563 TABLET, EXTENDED RELEASE 200 mg ORAL NDA 26 sections
TRAMADOL HYDROCHLORIDE HUMAN PRESCRIPTION DRUG LABEL 1 21695-699 TABLET, EXTENDED RELEASE 100 mg ORAL ANDA 24 sections
TRAMADOL HYDROCHLORIDE HUMAN PRESCRIPTION DRUG LABEL 1 21695-700 TABLET, EXTENDED RELEASE 200 mg ORAL ANDA 24 sections