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

Stem definitionDrug idCAS RN
sympathomimetic, phenethyl derivatives 1028 51-43-4

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • epinephrine
  • vasoconstrictine
  • nephridine
  • renoform
  • suprarenin
  • epinephrine bitartrate
  • (-)-adrenaline
  • epinephrine hydrochloride
The active sympathomimetic hormone from the ADRENAL MEDULLA. It stimulates both the alpha- and beta- adrenergic systems, causes systemic VASOCONSTRICTION and gastrointestinal relaxation, stimulates the HEART, and dilates BRONCHI and cerebral vessels. It is used in ASTHMA and CARDIAC FAILURE and to delay absorption of local ANESTHETICS.
  • Molecular weight: 183.21
  • Formula: C9H13NO3
  • CLOGP: -0.68
  • LIPINSKI: 0
  • HAC: 4
  • HDO: 4
  • TPSA: 72.72
  • ALOGS: -0.99
  • ROTB: 3

  • Status: OFP

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

Drug dosage:

DoseUnitRoute
0.50 mg P
2.24 mg Inhal.aerosol
20 mg Inhal.solution

ADMET properties:

PropertyValueReference
MRTD (Maximum Recommended Therapeutic Daily Dose) 0.09 ยตM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD

Approvals:

DateAgencyCompanyOrphan
Nov. 19, 1948 FDA

FDA Adverse Event Reporting System (Female)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Sinusitis 802.53 9.76 1454 115225 196127 55979261
Hereditary angioedema 578.93 9.76 283 116396 6552 56168836
Anaphylactic reaction 526.21 9.76 630 116049 58365 56117023
Local anaesthetic systemic toxicity 454.27 9.76 131 116548 603 56174785
Stress cardiomyopathy 424.85 9.76 246 116433 8090 56167298
Rheumatoid arthritis 385.13 9.76 156 116523 382448 55792940
Device failure 376.95 9.76 199 116480 5440 56169948
Toxic anterior segment syndrome 329.57 9.76 126 116553 1556 56173832
Anaesthetic complication 310.45 9.76 122 116557 1630 56173758
Contraindicated product administered 307.49 9.76 20 116659 186266 55989122
Pemphigus 296.33 9.76 6 116673 157206 56018182
Infusion site pain 295.63 9.76 238 116441 13524 56161864
Infusion site swelling 294.24 9.76 191 116488 7730 56167658
Cardiac arrest 290.07 9.76 587 116092 85727 56089661
Drug intolerance 279.49 9.76 100 116579 264718 55910670
Infusion site erythema 272.27 9.76 196 116483 9410 56165978
Hand deformity 250.06 9.76 6 116673 134486 56040902
Glossodynia 243.97 9.76 19 116660 152439 56022949
Joint swelling 240.67 9.76 152 116527 289648 55885740
Anaphylactic shock 232.23 9.76 255 116424 21485 56153903
Infusion site extravasation 231.50 9.76 167 116512 8043 56167345
Systemic lupus erythematosus 229.32 9.76 47 116632 180031 55995357
Accidental exposure to product 227.49 9.76 268 116411 24379 56151009
Synovitis 220.74 9.76 35 116644 161270 56014118
Bronchitis 219.79 9.76 619 116060 111692 56063696
Infusion site pruritus 203.73 9.76 126 116553 4681 56170707
Upper respiratory tract infection 193.74 9.76 445 116234 70843 56104545
Alopecia 191.03 9.76 196 116483 293262 55882126
Hepatic enzyme increased 187.13 9.76 61 116618 171323 56004065
Chondrolysis 179.77 9.76 49 116630 175 56175213
Arthropathy 171.79 9.76 101 116578 200174 55975214
COVID-19 167.15 9.76 434 116245 74624 56100764
Pulseless electrical activity 162.69 9.76 127 116552 6897 56168491
Pericarditis 155.08 9.76 21 116658 108902 56066486
Wound 154.00 9.76 48 116631 138756 56036632
Abdominal discomfort 153.87 9.76 210 116469 277064 55898324
Ear infection 150.95 9.76 249 116430 31046 56144342
Completed suicide 143.68 9.76 49 116630 133784 56041604
Therapeutic product effect decreased 143.12 9.76 87 116592 169365 56006023
Ventricular tachycardia 141.61 9.76 175 116504 16726 56158662
Infusion site bruising 135.47 9.76 80 116599 2729 56172659
Bradycardia 130.93 9.76 371 116308 67133 56108255
Hypotension 128.49 9.76 924 115755 249584 55925804
Infusion site haemorrhage 127.26 9.76 85 116594 3610 56171778
General physical health deterioration 125.45 9.76 101 116578 169909 56005479
Lagophthalmos 124.24 9.76 41 116638 317 56175071
Helicobacter infection 123.42 9.76 7 116672 73261 56102127
Kounis syndrome 122.81 9.76 58 116621 1240 56174148
Headache 117.49 9.76 1715 114964 557329 55618059
Urticaria 115.70 9.76 599 116080 144077 56031311
Respiratory tract infection 114.79 9.76 240 116439 35831 56139557
Treatment failure 113.95 9.76 111 116568 170281 56005107
Product quality issue 107.88 9.76 217 116462 31519 56143869
Administration site swelling 106.47 9.76 50 116629 1055 56174333
Corneal oedema 105.99 9.76 54 116625 1368 56174020
Infusion site nodule 103.11 9.76 51 116628 1211 56174177
Arthralgia 99.99 9.76 620 116059 501049 55674339
Maternal exposure during delivery 99.32 9.76 48 116631 1082 56174306
Angioedema 98.80 9.76 246 116433 41207 56134181
Incorrect drug administration rate 97.50 9.76 68 116611 3102 56172286
Incorrect route of product administration 96.58 9.76 165 116514 21164 56154224
Shock 95.65 9.76 166 116513 21562 56153826
Bronchospasm 91.29 9.76 136 116543 15533 56159855
Fear 89.16 9.76 131 116548 14777 56160611
Cardiogenic shock 88.47 9.76 137 116542 16188 56159200
Folliculitis 84.75 9.76 8 116671 54971 56120417
Asthma 84.03 9.76 458 116221 112312 56063076
Seasonal allergy 83.67 9.76 137 116542 16971 56158417
Ventricular fibrillation 83.18 9.76 108 116571 10844 56164544
Infusion site mass 81.28 9.76 46 116633 1446 56173942
Illness 80.35 9.76 203 116476 34308 56141080
Muscle injury 79.98 9.76 8 116671 52492 56122896
Stridor 79.41 9.76 61 116618 3234 56172154
Anhedonia 77.23 9.76 99 116580 9815 56165573
Left ventricle outflow tract obstruction 76.12 9.76 26 116653 226 56175162
Renal injury 76.02 9.76 93 116586 8794 56166594
Administration site pain 75.38 9.76 35 116644 719 56174669
Injection site ischaemia 74.99 9.76 15 116664 3 56175385
Cauda equina syndrome 74.22 9.76 37 116642 894 56174494
Unevaluable event 73.62 9.76 242 116437 47445 56127943
Injury associated with device 70.21 9.76 57 116622 3276 56172112
Impaired healing 69.96 9.76 47 116632 86794 56088594
Discomfort 68.31 9.76 118 116561 141643 56033745
Psoriatic arthropathy 68.23 9.76 34 116645 73974 56101414
Impaired quality of life 68.19 9.76 86 116593 8388 56167000
Methaemoglobinaemia 67.95 9.76 47 116632 2115 56173273
Expired product administered 67.38 9.76 70 116609 5532 56169856
Tachycardia 67.12 9.76 412 116267 105464 56069924
Infusion site urticaria 66.62 9.76 38 116641 1213 56174175
Migraine 66.32 9.76 355 116324 86442 56088946
Needle issue 66.10 9.76 86 116593 8652 56166736
Injection site pallor 65.64 9.76 17 116662 47 56175341
Infusion site rash 65.61 9.76 41 116638 1551 56173837
Electrocardiogram ST segment elevation 65.43 9.76 57 116622 3612 56171776
Pulse absent 63.25 9.76 64 116615 4903 56170485
Endophthalmitis 62.54 9.76 52 116627 3091 56172297
Product use issue 62.01 9.76 189 116490 185852 55989536
Arteriospasm coronary 61.72 9.76 55 116624 3592 56171796
Diarrhoea 61.47 9.76 943 115736 637564 55537824
Confusional state 60.80 9.76 224 116455 207931 55967457
Musculoskeletal stiffness 60.61 9.76 147 116532 155860 56019528
Administration site erythema 60.22 9.76 28 116651 577 56174811
Neutropenia 59.91 9.76 151 116528 158016 56017372
Peripheral ischaemia 59.58 9.76 59 116620 4404 56170984
Liquid product physical issue 59.04 9.76 32 116647 923 56174465
Product dose omission issue 58.76 9.76 666 116013 204087 55971301
Swelling 57.69 9.76 278 116401 239493 55935895
Airway peak pressure increased 57.44 9.76 22 116657 273 56175115
Urinary tract infection 57.18 9.76 755 115924 239758 55935630
Type 2 diabetes mellitus 56.04 9.76 14 116665 46848 56128540
Hyponatraemia 55.90 9.76 78 116601 102061 56073327
Acute kidney injury 54.58 9.76 285 116394 240478 55934910
COVID-19 immunisation 54.00 9.76 35 116644 1412 56173976
Blister 53.96 9.76 89 116590 108798 56066590
Hypopyon 53.07 9.76 27 116652 682 56174706
Electrocardiogram ST segment depression 52.58 9.76 44 116635 2639 56172749
Lower respiratory tract infection 52.21 9.76 99 116580 114695 56060693
Staphylococcal infection 52.00 9.76 184 116495 37434 56137954
Generalised tonic-clonic seizure 51.95 9.76 150 116529 27416 56147972
Inappropriate schedule of product administration 51.90 9.76 323 116356 83064 56092324
Haemodynamic instability 50.98 9.76 74 116605 8255 56167133
Mobility decreased 50.85 9.76 79 116600 98912 56076476
Insurance issue 50.38 9.76 50 116629 3742 56171646
Infusion site irritation 50.35 9.76 26 116653 678 56174710
Decreased appetite 49.97 9.76 259 116420 218972 55956416
Body tinea 49.71 9.76 33 116646 1387 56174001
Cataract operation complication 49.26 9.76 16 116663 117 56175271
Extradural abscess 48.91 9.76 27 116652 808 56174580
Emotional distress 48.61 9.76 154 116525 29609 56145779
Lip swelling 48.59 9.76 142 116537 26130 56149258
C-reactive protein increased 48.36 9.76 55 116624 78629 56096759
Kidney infection 48.33 9.76 122 116557 20603 56154785
C-reactive protein abnormal 48.08 9.76 9 116670 36800 56138588
Blood cholesterol increased 47.65 9.76 48 116631 72531 56102857
Liver injury 47.23 9.76 14 116665 41834 56133554
Tryptase increased 47.12 9.76 20 116659 329 56175059
Circulatory collapse 47.00 9.76 121 116558 20682 56154706
Procedural hypotension 45.76 9.76 29 116650 1125 56174263
Fungal infection 45.28 9.76 161 116518 32832 56142556
Post procedural complication 44.97 9.76 100 116579 15566 56159822
Vasoplegia syndrome 44.48 9.76 30 116649 1295 56174093
Stomatitis 44.46 9.76 117 116562 120693 56054695
Chills 43.85 9.76 363 116316 102241 56073147
Psoriasis 42.97 9.76 79 116600 92613 56082775
Pharyngeal oedema 42.96 9.76 89 116590 13196 56162192
Ventricular hypokinesia 42.65 9.76 48 116631 4153 56171235
Pulmonary oedema 42.39 9.76 214 116465 50929 56124459
Infusion site discomfort 41.97 9.76 27 116652 1075 56174313
Anaesthetic complication neurological 41.96 9.76 16 116663 196 56175192
Status asthmaticus 41.52 9.76 25 116654 884 56174504
Blood pressure decreased 40.75 9.76 235 116444 58815 56116573
Intentional self-injury 40.27 9.76 3 116676 24989 56150399
Wrong product administered 40.09 9.76 54 116625 5618 56169770
Infusion site reaction 39.97 9.76 39 116640 2859 56172529
Extradural haematoma 39.39 9.76 30 116649 1570 56173818
Peripheral swelling 38.77 9.76 306 116373 234420 55940968
Eye infection 38.39 9.76 73 116606 10171 56165217
Anaemia 37.86 9.76 363 116316 267148 55908240
Swollen tongue 37.43 9.76 143 116536 30181 56145207
Seizure 36.77 9.76 409 116270 124710 56050678
Vitritis 35.75 9.76 23 116656 916 56174472
Blood creatinine increased 35.72 9.76 70 116609 80121 56095267
Disease progression 35.62 9.76 106 116573 105067 56070321
Laryngeal oedema 35.19 9.76 49 116630 5261 56170127
Hypoaesthesia oral 35.13 9.76 75 116604 11356 56164032
Cystitis 35.04 9.76 197 116482 48841 56126547
Pancytopenia 34.90 9.76 83 116596 88632 56086756
Abortion spontaneous 34.80 9.76 24 116655 43729 56131659
Multiple allergies 34.75 9.76 71 116608 10425 56164963
Dermatitis contact 34.61 9.76 67 116612 9460 56165928
Troponin I increased 34.46 9.76 31 116648 2050 56173338
Injection site injury 34.41 9.76 19 116660 569 56174819
Administration site reaction 34.28 9.76 14 116665 208 56175180
Administration site pruritus 34.26 9.76 15 116664 267 56175121
Procedural complication 34.20 9.76 47 116632 4984 56170404
Removal of foreign body 34.14 9.76 8 116671 12 56175376
Embolia cutis medicamentosa 34.01 9.76 16 116663 339 56175049
Unresponsive to stimuli 33.88 9.76 143 116536 31582 56143806
Infection susceptibility increased 33.88 9.76 35 116644 2748 56172640
Irritable bowel syndrome 33.86 9.76 56 116623 68402 56106986
Anaphylactoid reaction 33.80 9.76 39 116640 3467 56171921
Condition aggravated 33.52 9.76 508 116171 344390 55830998
Platelet aggregation inhibition 33.30 9.76 12 116667 124 56175264
Inhibitory drug interaction 33.18 9.76 32 116647 2312 56173076
Malignant neoplasm progression 32.98 9.76 64 116615 73523 56101865
Hyperaesthesia 32.83 9.76 62 116617 8595 56166793
Chest discomfort 32.71 9.76 331 116348 98526 56076862
Injury 32.46 9.76 224 116455 59627 56115761
Nerve root injury 32.42 9.76 9 116670 35 56175353
Loss of personal independence in daily activities 32.11 9.76 76 116603 81293 56094095
Ophthalmoplegia 31.85 9.76 25 116654 1368 56174020
Product contamination microbial 31.53 9.76 13 116666 198 56175190
Leukopenia 31.53 9.76 62 116617 70878 56104510
Injection site hypoaesthesia 31.52 9.76 16 116663 402 56174986
Administration site bruise 31.37 9.76 15 116664 330 56175058
Throat tightness 31.31 9.76 110 116569 22297 56153091
Sinus tachycardia 31.20 9.76 110 116569 22334 56153054
Pharyngitis streptococcal 31.15 9.76 64 116615 9434 56165954
Thrombocytopenia 30.98 9.76 161 116518 136063 56039325
Drug reaction with eosinophilia and systemic symptoms 30.96 9.76 12 116667 30292 56145096
Anterior chamber cell 30.94 9.76 17 116662 504 56174884
Gastroenteritis viral 30.93 9.76 103 116576 20321 56155067
Injection site coldness 30.45 9.76 10 116669 76 56175312
Infusion site warmth 30.23 9.76 25 116654 1475 56173913
Administration site extravasation 29.89 9.76 19 116660 741 56174647
Type I hypersensitivity 29.87 9.76 31 116648 2447 56172941
Pharyngeal swelling 29.41 9.76 45 116634 5261 56170127
Asthenia 29.40 9.76 517 116162 342456 55832932
Uterine hypertonus 29.36 9.76 14 116665 306 56175082
Nerve block 29.36 9.76 18 116661 658 56174730
Phrenic nerve paralysis 29.34 9.76 12 116667 179 56175209
Anxiety 29.05 9.76 562 116117 192610 55982778
Drug ineffective for unapproved indication 28.36 9.76 117 116562 25576 56149812
Neuromuscular block prolonged 28.33 9.76 16 116663 501 56174887
Bladder prolapse 28.31 9.76 27 116652 1924 56173464
Fear of eating 28.05 9.76 14 116665 339 56175049
Liver function test abnormal 27.97 9.76 32 116647 45639 56129749
Myocardial ischaemia 27.91 9.76 71 116608 12045 56163343
Death 27.90 9.76 519 116160 340907 55834481
Cyanosis 27.85 9.76 84 116595 15726 56159662
Mydriasis 27.75 9.76 67 116612 11004 56164384
Paraplegia 27.70 9.76 30 116649 2487 56172901
Vasospasm 27.54 9.76 17 116662 629 56174759
Aqueous fibrin 27.45 9.76 9 116670 68 56175320
Poor venous access 27.20 9.76 71 116608 12235 56163153
Stress 27.10 9.76 212 116467 58698 56116690
Tooth infection 27.10 9.76 83 116596 15669 56159719
Skin infection 27.02 9.76 74 116605 13121 56162267
Cholestasis 26.93 9.76 11 116668 26902 56148486
Gas gangrene 26.79 9.76 10 116669 115 56175273
Sinus disorder 26.60 9.76 99 116580 20635 56154753
Bursitis infective 26.42 9.76 22 116657 1310 56174078
Ventricular extrasystoles 26.41 9.76 65 116614 10805 56164583
Paralysis 26.31 9.76 58 116621 8974 56166414
Hepatotoxicity 26.26 9.76 16 116663 31137 56144251
Blood pH decreased 26.18 9.76 29 116650 2465 56172923
Peripheral nerve injury 26.08 9.76 14 116665 396 56174992
Meningitis chemical 26.04 9.76 10 116669 125 56175263
Drug abuse 26.00 9.76 64 116615 67546 56107842
Hip arthroplasty 25.97 9.76 25 116654 38598 56136790
Bundle branch block left 25.93 9.76 47 116632 6315 56169073
Anaphylactoid shock 25.86 9.76 13 116666 320 56175068
Adverse event 25.84 9.76 47 116632 55329 56120059
Corneal epithelium defect 25.67 9.76 13 116666 325 56175063
Red blood cell sedimentation rate increased 25.46 9.76 23 116656 36600 56138788
Sinus operation 25.37 9.76 26 116653 2022 56173366
PO2 decreased 25.29 9.76 22 116657 1391 56173997
Wheezing 25.20 9.76 252 116427 74774 56100614
Pneumocephalus 25.15 9.76 10 116669 138 56175250
Spinal stroke 25.06 9.76 7 116672 28 56175360
Abdominal pain upper 24.76 9.76 243 116436 178070 55997318
Influenza like illness 24.58 9.76 213 116466 60775 56114613
Tracheal deviation 24.52 9.76 10 116669 148 56175240
Limb injury 24.26 9.76 101 116578 22169 56153219
Eyelid rash 24.23 9.76 9 116670 102 56175286
Axillary nerve injury 24.20 9.76 6 116673 13 56175375
Glucose tolerance impaired 24.15 9.76 42 116637 5463 56169925
Myopathy toxic 23.96 9.76 14 116665 468 56174920
Rectal prolapse 23.59 9.76 24 116655 1850 56173538
Parophthalmia 23.45 9.76 12 116667 307 56175081
Upper airway obstruction 23.35 9.76 15 116664 596 56174792
Systemic toxicity 23.32 9.76 7 116672 38 56175350
Cardiac failure congestive 23.28 9.76 98 116581 87622 56087766
Respiratory acidosis 23.20 9.76 44 116635 6119 56169269
Drug resistance 22.95 9.76 7 116672 20535 56154853
Orthostatic hypotension 22.90 9.76 21 116658 33178 56142210
Septic arthritis staphylococcal 22.85 9.76 13 116666 413 56174975
Heart rate increased 22.56 9.76 268 116411 83005 56092383
Troponin T increased 22.36 9.76 18 116661 1022 56174366
Retinal vasculitis 22.35 9.76 17 116662 888 56174500
Multiple organ dysfunction syndrome 22.16 9.76 186 116493 52584 56122804
Device infusion issue 22.13 9.76 22 116657 1650 56173738
Cranial nerve palsies multiple 22.11 9.76 6 116673 21 56175367
Osteonecrosis of jaw 21.96 9.76 22 116657 33336 56142052
Trigemino-cardiac reflex 21.94 9.76 7 116672 48 56175340
Supraventricular tachycardia 21.91 9.76 69 116610 13222 56162166
Retinal artery occlusion 21.78 9.76 21 116658 1517 56173871
Infusion site discolouration 21.59 9.76 15 116664 680 56174708
Immunisation reaction 21.51 9.76 11 116668 281 56175107
Prescribed underdose 21.34 9.76 8 116671 20609 56154779
Device expulsion 21.31 9.76 19 116660 30430 56144958
Spinal operation 21.16 9.76 47 116632 7309 56168079
Spinal epidural haemorrhage 20.69 9.76 8 116671 102 56175286
Arterial spasm 20.68 9.76 7 116672 59 56175329
PCO2 increased 20.53 9.76 18 116661 1150 56174238
Liver disorder 20.39 9.76 38 116641 44332 56131056
Inflammation 20.35 9.76 74 116605 68997 56106391
Vitamin D increased 20.32 9.76 14 116665 626 56174762
Sleep disorder 20.26 9.76 72 116607 67591 56107797
Paraesthesia oral 20.24 9.76 71 116608 14378 56161010
Sensory loss 20.21 9.76 52 116627 8883 56166505
Lung hyperinflation 20.14 9.76 18 116661 1180 56174208
Postresuscitation encephalopathy 20.11 9.76 5 116674 11 56175377
Local reaction 20.10 9.76 14 116665 637 56174751
Blood lactic acid increased 20.05 9.76 41 116638 6023 56169365
Nystagmus 19.99 9.76 40 116639 5785 56169603
White blood cell count decreased 19.97 9.76 166 116513 125824 56049564
Rash 19.86 9.76 828 115851 492219 55683169
Oral herpes 19.82 9.76 97 116582 22793 56152595
Electrocardiogram T wave inversion 19.45 9.76 29 116650 3314 56172074
Injection site pain 19.42 9.76 346 116333 116772 56058616
Inability to afford medication 19.36 9.76 21 116658 1744 56173644
Administration site nodule 19.35 9.76 6 116673 37 56175351
Fear of death 19.31 9.76 16 116663 946 56174442
Administration site irritation 19.21 9.76 6 116673 38 56175350
Apnoeic attack 19.12 9.76 10 116669 268 56175120
Blood pressure increased 19.05 9.76 414 116265 144762 56030626
Therapy interrupted 19.01 9.76 104 116575 25521 56149867
Injection site inflammation 18.97 9.76 29 116650 3387 56172001
Reversible cerebral vasoconstriction syndrome 18.93 9.76 24 116655 2353 56173035
Poor quality sleep 18.93 9.76 80 116599 17675 56157713
Anal skin tags 18.92 9.76 12 116667 466 56174922
Hypocalcaemia 18.89 9.76 19 116660 28741 56146647
Administration site haemorrhage 18.72 9.76 7 116672 81 56175307
Harlequin syndrome 18.70 9.76 6 116673 42 56175346
Infusion site scar 18.60 9.76 11 116668 376 56175012
Meningitis aseptic 18.57 9.76 33 116646 4366 56171022
Atonic urinary bladder 18.56 9.76 7 116672 83 56175305
Knee arthroplasty 18.55 9.76 40 116639 44219 56131169
Gastrointestinal disorder 18.55 9.76 147 116532 112555 56062833
Therapeutic product effect incomplete 18.53 9.76 136 116543 105895 56069493
No adverse event 18.47 9.76 134 116545 36240 56139148
Spinal anaesthesia 18.46 9.76 6 116673 44 56175344
Administration site discolouration 18.34 9.76 6 116673 45 56175343
Ischaemia 18.33 9.76 33 116646 4410 56170978
Vocal cord dysfunction 18.27 9.76 11 116668 389 56174999
Product adhesion issue 18.12 9.76 33 116646 4450 56170938
Creatinine renal clearance decreased 18.10 9.76 4 116675 14555 56160833
Eyelid ptosis 18.03 9.76 41 116638 6478 56168910
Hepatocellular injury 18.02 9.76 17 116662 26497 56148891
Neurogenic shock 17.94 9.76 10 116669 305 56175083
Accidental overdose 17.93 9.76 87 116592 20374 56155014
Infusion site induration 17.90 9.76 15 116664 901 56174487
Mean arterial pressure decreased 17.85 9.76 8 116671 151 56175237
Loss of consciousness 17.76 9.76 322 116357 109027 56066361
Constipation 17.73 9.76 303 116376 201640 55973748
Vasoconstriction 17.65 9.76 12 116667 525 56174863
Interstitial lung disease 17.57 9.76 60 116619 57003 56118385
Conjunctival oedema 17.55 9.76 13 116666 652 56174736
Ill-defined disorder 17.32 9.76 78 116601 68465 56106923
Enzyme induction 17.19 9.76 6 116673 56 56175332
Systolic anterior motion of mitral valve 17.17 9.76 5 116674 24 56175364
Off label use 17.09 9.76 961 115718 555219 55620169
Spinal cord infarction 17.08 9.76 9 116670 245 56175143
Product measured potency issue 17.08 9.76 7 116672 105 56175283
Punctate keratitis 17.06 9.76 12 116667 555 56174833
Neoplasm progression 16.96 9.76 25 116654 31991 56143397
Respiratory distress 16.86 9.76 118 116561 31549 56143839
Jaundice 16.85 9.76 19 116660 27275 56148113
Urticaria chronic 16.72 9.76 12 116667 573 56174815
Influenza 16.71 9.76 284 116395 94977 56080411
Propofol infusion syndrome 16.71 9.76 14 116665 841 56174547
Food allergy 16.61 9.76 48 116631 8776 56166612
Extremity necrosis 16.54 9.76 18 116661 1500 56173888
Glossoptosis 16.48 9.76 6 116673 64 56175324
Respiratory depression 16.48 9.76 60 116619 12375 56163013
Hepatic cirrhosis 16.47 9.76 12 116667 21251 56154137
Central venous catheterisation 16.41 9.76 23 116656 2484 56172904
Device ineffective 16.29 9.76 8 116671 187 56175201
ECG signs of myocardial ischaemia 16.15 9.76 6 116673 68 56175320
Gastric infection 16.13 9.76 26 116653 3178 56172210
Arachnoiditis 16.07 9.76 9 116670 277 56175111
Hypomagnesaemia 15.90 9.76 17 116662 24998 56150390
Muscle tightness 15.84 9.76 54 116625 10782 56164606
Viral infection 15.83 9.76 117 116562 31829 56143559
Obesity 15.72 9.76 14 116665 22434 56152954
Distributive shock 15.64 9.76 15 116664 1076 56174312
Abdominal pain 15.50 9.76 413 116266 258392 55916996
Brain injury 15.44 9.76 38 116641 6317 56169071
Normal newborn 15.40 9.76 42 116637 7428 56167960
Platelet count decreased 15.17 9.76 144 116535 106239 56069149
Eye infarction 15.00 9.76 5 116674 40 56175348
Mast cell activation syndrome 14.93 9.76 12 116667 680 56174708
Therapeutic product effect prolonged 14.88 9.76 9 116670 321 56175067
Diplegia 14.88 9.76 14 116665 981 56174407
Meningitis 14.86 9.76 38 116641 6466 56168922
Product distribution issue 14.84 9.76 14 116665 984 56174404
Accidental exposure to product by child 14.73 9.76 15 116664 1158 56174230
Cold sweat 14.67 9.76 53 116626 10890 56164498
Neuroleptic malignant syndrome 14.58 9.76 3 116676 11475 56163913
Osteoarthritis 14.51 9.76 102 116577 80194 56095194
Blindness 14.50 9.76 76 116603 18345 56157043
Cardiac assistance device user 14.49 9.76 5 116674 45 56175343
Metastases to liver 14.48 9.76 14 116665 21572 56153816
Gastrointestinal haemorrhage 14.46 9.76 95 116584 75856 56099532
Status epilepticus 14.45 9.76 66 116613 15075 56160313
Plasma cell myeloma 14.39 9.76 49 116630 46597 56128791
Administration site scar 14.39 9.76 5 116674 46 56175342
Postpartum disorder 14.32 9.76 4 116675 16 56175372
Hypercalcaemia 14.30 9.76 19 116660 25392 56149996
Product availability issue 14.23 9.76 24 116655 3045 56172343
Drug tolerance decreased 14.22 9.76 5 116674 13406 56161982
Apnoea 14.22 9.76 40 116639 7202 56168186
Pneumonia mycoplasmal 14.20 9.76 13 116666 879 56174509
Animal bite 14.19 9.76 22 116657 2601 56172787
Haematochezia 14.13 9.76 45 116634 43673 56131715
Respiratory tract oedema 14.09 9.76 10 116669 469 56174919
Spinal epidural haematoma 14.05 9.76 14 116665 1053 56174335
Scar 14.02 9.76 57 116622 12376 56163012
Gastroenteritis 14 9.76 18 116661 24394 56150994
Tongue pruritus 14.00 9.76 10 116669 474 56174914
Visual acuity reduced 13.98 9.76 82 116597 20644 56154744
Delayed recovery from anaesthesia 13.97 9.76 12 116667 746 56174642
Injection site extravasation 13.96 9.76 43 116636 8141 56167247
Rotator cuff syndrome 13.96 9.76 56 116623 12087 56163301
Neutropenic sepsis 13.95 9.76 7 116672 15178 56160210
Inadequate analgesia 13.89 9.76 22 116657 2649 56172739
Paranasal cyst 13.89 9.76 9 116670 363 56175025
Epidural analgesia 13.85 9.76 5 116674 52 56175336
Hallucination, tactile 13.84 9.76 8 116671 262 56175126
International normalised ratio increased 13.77 9.76 46 116633 43995 56131393
Nail bed tenderness 13.73 9.76 9 116670 370 56175018
Throat irritation 13.61 9.76 115 116564 32568 56142820
Incision site rash 13.60 9.76 4 116675 20 56175368
Trigeminal palsy 13.60 9.76 4 116675 20 56175368
Forced vital capacity abnormal 13.60 9.76 4 116675 20 56175368
Malabsorption from administration site 13.54 9.76 6 116673 110 56175278
Depressed mood 13.53 9.76 35 116644 36324 56139064
SARS-CoV-2 test false positive 13.47 9.76 3 116676 3 56175385
Caffeine allergy 13.44 9.76 4 116675 21 56175367
Vaccination site rash 13.44 9.76 4 116675 21 56175367
Infusion site oedema 13.39 9.76 11 116668 643 56174745
Diplopia 13.36 9.76 80 116599 20289 56155099
Blood pressure immeasurable 13.32 9.76 14 116665 1121 56174267
Chondromalacia 13.26 9.76 8 116671 284 56175104
Colour blindness 13.16 9.76 8 116671 288 56175100
Oedema peripheral 13.14 9.76 263 116416 170991 56004397
Pain in extremity 13.13 9.76 494 116185 296937 55878451
Procedural haemorrhage 13.13 9.76 21 116658 2550 56172838
Foetal heart rate abnormal 13.10 9.76 10 116669 525 56174863
Mastocytosis 13.07 9.76 10 116669 527 56174861
Pneumonia 13.07 9.76 996 115683 406102 55769286
Systolic dysfunction 13.07 9.76 16 116663 1514 56173874
Smoke sensitivity 13.05 9.76 9 116670 403 56174985
Femur fracture 13.01 9.76 40 116639 39255 56136133
Myocardial necrosis marker increased 13.01 9.76 17 116662 1717 56173671
Catheter site pain 13.00 9.76 28 116651 4265 56171123
Spinal cord oedema 12.98 9.76 6 116673 122 56175266
Colitis ulcerative 12.97 9.76 19 116660 24372 56151016
Vaccination complication 12.95 9.76 13 116666 986 56174402
Hypercapnia 12.94 9.76 31 116648 5065 56170323
Administration site rash 12.91 9.76 5 116674 64 56175324
Gastric mucosa erythema 12.82 9.76 8 116671 302 56175086
Arthritis bacterial 12.77 9.76 34 116645 5927 56169461
Peritonitis 12.73 9.76 9 116670 16193 56159195
Vascular stenosis 12.70 9.76 8 116671 307 56175081
Procedural anxiety 12.68 9.76 11 116668 693 56174695
Device issue 12.65 9.76 81 116598 21025 56154363
Bacterial infection 12.63 9.76 70 116609 17260 56158128
Left ventricular dysfunction 12.55 9.76 51 116628 11072 56164316
CSF pressure increased 12.55 9.76 6 116673 132 56175256
Depression 12.53 9.76 281 116398 179836 55995552
Joint stiffness 12.50 9.76 35 116644 35390 56139998
Thermal burn 12.49 9.76 32 116647 5453 56169935
Quadriparesis 12.48 9.76 17 116662 1787 56173601
Alanine aminotransferase increased 12.43 9.76 129 116550 93533 56081855
Musculoskeletal pain 12.37 9.76 108 116571 81044 56094344
Administration site mass 12.34 9.76 4 116675 29 56175359
Product contamination 12.33 9.76 10 116669 574 56174814
Disease recurrence 12.28 9.76 19 116660 23841 56151547
Maternal exposure during pregnancy 12.28 9.76 299 116380 189254 55986134
Oropharyngeal discomfort 12.24 9.76 28 116651 4440 56170948
Suicide attempt 12.23 9.76 70 116609 57766 56117622
Metabolic acidosis 12.22 9.76 133 116546 40321 56135067
Irregular breathing 12.21 9.76 8 116671 329 56175059
Eye inflammation 12.17 9.76 29 116650 4722 56170666
Anal sphincter atony 12.14 9.76 7 116672 228 56175160
Sinus bradycardia 12.07 9.76 58 116621 13528 56161860
Autonomic neuropathy 12.06 9.76 13 116666 1072 56174316
Transaminases increased 12.06 9.76 26 116653 28744 56146644
Nasal discharge discolouration 12.03 9.76 17 116662 1850 56173538
Streptococcal infection 11.96 9.76 30 116649 5045 56170343
Hypoxia 11.87 9.76 167 116512 53730 56121658
Ehlers-Danlos syndrome 11.85 9.76 6 116673 150 56175238
Product contamination physical 11.85 9.76 5 116674 81 56175307
Pupil fixed 11.81 9.76 16 116663 1674 56173714
Hepatitis 11.79 9.76 36 116643 35405 56139983
Heart rate decreased 11.79 9.76 132 116547 40295 56135093
Overdose 11.78 9.76 295 116384 105535 56069853
Product administration error 11.74 9.76 79 116600 20850 56154538
Pain in jaw 11.72 9.76 43 116636 39993 56135395
Post procedural infection 11.72 9.76 41 116638 8291 56167097
Post-anoxic myoclonus 11.69 9.76 4 116675 35 56175353
Cutis laxa 11.67 9.76 6 116673 155 56175233
Balance disorder 11.59 9.76 102 116577 76418 56098970
Melaena 11.50 9.76 26 116653 28264 56147124
Propionibacterium infection 11.49 9.76 4 116675 37 56175351
Genital ulceration 11.49 9.76 9 116670 491 56174897
Application site alopecia 11.40 9.76 3 116676 9 56175379
Decreased ventricular preload 11.40 9.76 3 116676 9 56175379
Injection site haemorrhage 11.40 9.76 82 116597 22119 56153269
Malignant melanoma 11.36 9.76 4 116675 10715 56164673
Oropharyngeal pain 11.32 9.76 240 116439 83548 56091840
Foot deformity 11.31 9.76 20 116659 23805 56151583
Poor quality product administered 11.29 9.76 21 116658 2878 56172510
Blood calcium decreased 11.24 9.76 20 116659 23749 56151639
Device use issue 11.24 9.76 18 116661 2188 56173200
Electrocardiogram U wave present 11.22 9.76 5 116674 93 56175295
Mental status changes 11.19 9.76 123 116556 37378 56138010
XIIth nerve injury 11.17 9.76 3 116676 10 56175378
Cholestasis of pregnancy 11.16 9.76 13 116666 1168 56174220
Capillary nail refill test abnormal 11.13 9.76 4 116675 41 56175347
Hypoxic-ischaemic encephalopathy 11.12 9.76 25 116654 3920 56171468
Cardiac arrest neonatal 11.08 9.76 5 116674 96 56175292
Orbital infection 11.04 9.76 4 116675 42 56175346
Vascular resistance systemic decreased 11.03 9.76 5 116674 97 56175291
Food poisoning 11.02 9.76 24 116655 3682 56171706
Blood bilirubin increased 11.01 9.76 34 116645 33320 56142068
Ventricular arrhythmia 11.00 9.76 23 116656 3431 56171957
Urticarial vasculitis 10.99 9.76 10 116669 671 56174717
Psychotic disorder 10.98 9.76 20 116659 23538 56151850
Epinephrine increased 10.94 9.76 3 116676 11 56175377
Disseminated intravascular coagulation 10.94 9.76 69 116610 17816 56157572
SARS-CoV-2 test positive 10.88 9.76 33 116646 6196 56169192
Breast cancer female 10.88 9.76 6 116673 12332 56163056
Anaphylactoid syndrome of pregnancy 10.88 9.76 4 116675 44 56175344
Lung neoplasm malignant 10.86 9.76 12 116667 17384 56158004
Biopsy lung 10.86 9.76 6 116673 180 56175208
Optic atrophy 10.85 9.76 13 116666 1203 56174185
Cardio-respiratory arrest 10.84 9.76 168 116511 55153 56120235
Bradycardia foetal 10.81 9.76 8 116671 401 56174987
Pulmonary fibrosis 10.80 9.76 29 116650 29729 56145659
Product leakage 10.79 9.76 10 116669 687 56174701
Tremor 10.79 9.76 328 116351 120761 56054627
Drug-induced liver injury 10.77 9.76 36 116643 34426 56140962
Arthropod sting 10.72 9.76 12 116667 1032 56174356
Cognitive disorder 10.64 9.76 59 116620 49074 56126314
Low cardiac output syndrome 10.63 9.76 7 116672 290 56175098
Intercepted medication error 10.60 9.76 9 116670 551 56174837
Central venous catheter removal 10.58 9.76 8 116671 414 56174974
Metastases to bone 10.56 9.76 15 116664 19493 56155895
Ascites 10.55 9.76 41 116638 37503 56137885
Victim of spousal abuse 10.55 9.76 3 116676 13 56175375
Electrocardiogram QRS complex prolonged 10.54 9.76 30 116649 5437 56169951
Erythema 10.52 9.76 409 116270 155530 56019858
Lip disorder 10.49 9.76 13 116666 1245 56174143
N-terminal prohormone brain natriuretic peptide 10.49 9.76 4 116675 49 56175339
Right ventricular dysfunction 10.46 9.76 15 116664 1654 56173734
Coronary artery disease 10.45 9.76 31 116648 30765 56144623
Infected bite 10.44 9.76 15 116664 1657 56173731
Gastrointestinal bacterial overgrowth 10.44 9.76 9 116670 562 56174826
Ocular retrobulbar haemorrhage 10.41 9.76 5 116674 111 56175277
Dental restoration failure 10.40 9.76 10 116669 720 56174668
Hyperlactacidaemia 10.39 9.76 19 116660 2569 56172819
Product use in unapproved indication 10.38 9.76 373 116306 140449 56034939
Injection site abscess 10.33 9.76 12 116667 1074 56174314
Laryngeal obstruction 10.33 9.76 5 116674 113 56175275
Eosinophilia 10.32 9.76 16 116663 20061 56155327
Corneal abrasion 10.30 9.76 11 116668 897 56174491
Transferrin decreased 10.23 9.76 6 116673 202 56175186
Arthritis fungal 10.20 9.76 3 116676 15 56175373
Nail bed infection bacterial 10.20 9.76 3 116676 15 56175373
Gait disturbance 10.20 9.76 259 116420 163062 56012326
Coccygectomy 10.20 9.76 3 116676 15 56175373
Vitamin E decreased 10.20 9.76 3 116676 15 56175373
Localised infection 10.15 9.76 94 116585 27318 56148070
Airway complication of anaesthesia 10.12 9.76 6 116673 206 56175182
Cold urticaria 10.07 9.76 4 116675 55 56175333
Nephrolithiasis 10.04 9.76 120 116559 37215 56138173
Epidural haemorrhage 10.02 9.76 5 116674 121 56175267
Weight fluctuation 10.02 9.76 38 116641 7990 56167398
Exposure during pregnancy 10.02 9.76 361 116318 135981 56039407
Body dysmorphic disorder 10.00 9.76 7 116672 321 56175067
Respiratory failure 10 9.76 263 116416 94799 56080589
Quadriplegia 10 9.76 15 116664 1723 56173665
Electrocardiogram P wave abnormal 9.99 9.76 6 116673 211 56175177
Gamma-glutamyltransferase increased 9.96 9.76 32 116647 30973 56144415
Akinesia 9.92 9.76 14 116665 1522 56173866
Tubulointerstitial nephritis 9.86 9.76 12 116667 16653 56158735
Rhabdomyolysis 9.84 9.76 47 116632 40611 56134777
Sedation complication 9.83 9.76 6 116673 11666 56163722
Vocal cord disorder 9.82 9.76 13 116666 1330 56174058
Weight increased 9.80 9.76 383 116296 229320 55946068
Atrioventricular block complete 9.79 9.76 36 116643 7458 56167930
Hyposmia 9.79 9.76 9 116670 612 56174776
Circumstance or information capable of leading to device use error 9.77 9.76 5 116674 128 56175260

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
Anaphylactic reaction 419.86 10.53 391 60743 29162 31607048
Device failure 369.36 10.53 143 60991 1980 31634230
Sinusitis 315.15 10.53 371 60763 36325 31599885
Drug ineffective 272.64 10.53 1487 59647 394086 31242124
Cardiac arrest 272.43 10.53 558 60576 88504 31547706
Anaesthetic complication 251.11 10.53 89 61045 945 31635265
Anaphylactic shock 248.19 10.53 211 60923 13934 31622276
Toxic anterior segment syndrome 192.93 10.53 75 61059 1050 31635160
Chondrolysis 157.36 10.53 38 61096 78 31636132
Fear 157.23 10.53 140 60994 9834 31626376
Ventricular tachycardia 156.13 10.53 210 60924 23491 31612719
Injury 153.93 10.53 190 60944 19519 31616691
Methaemoglobinaemia 151.78 10.53 86 61048 2920 31633290
Local anaesthetic systemic toxicity 146.62 10.53 42 61092 205 31636005
Hypotension 144.55 10.53 776 60358 203842 31432368
Hereditary angioedema 142.65 10.53 59 61075 979 31635231
Renal injury 141.56 10.53 136 60998 10529 31625681
Stress cardiomyopathy 120.54 10.53 62 61072 1728 31634482
Accidental exposure to product 118.68 10.53 128 61006 11367 31624843
Ear infection 113.64 10.53 111 61023 8770 31627440
Anhedonia 112.44 10.53 102 61032 7340 31628870
Emotional distress 111.45 10.53 138 60996 14218 31621992
Infusion site swelling 110.66 10.53 62 61072 2059 31634151
Ventricular fibrillation 106.25 10.53 155 60979 18693 31617517
Bradycardia 102.16 10.53 330 60804 68997 31567213
Injection site pallor 99.81 10.53 19 61115 0 31636210
Infusion site pain 98.86 10.53 67 61067 3139 31633071
Unevaluable event 96.14 10.53 194 60940 30381 31605829
Electrocardiogram ST segment elevation 91.16 10.53 74 61060 4577 31631633
Needle issue 91.12 10.53 78 61056 5195 31631015
Injection site laceration 88.23 10.53 19 61115 16 31636194
Lagophthalmos 87.17 10.53 23 61111 77 31636133
Accidental exposure to product by child 81.35 10.53 45 61089 1457 31634753
Product quality issue 80.14 10.53 125 61009 15986 31620224
Drug ineffective for unapproved indication 78.89 10.53 131 61003 17659 31618551
Diarrhoea 77.73 10.53 383 60751 352026 31284184
Shock 77.61 10.53 149 60985 22496 31613714
Bronchospasm 74.43 10.53 94 61040 9878 31626332
Infusion site extravasation 73.68 10.53 59 61075 3578 31632632
Arteriospasm coronary 71.94 10.53 53 61081 2838 31633372
Vasoplegia syndrome 70.66 10.53 43 61091 1670 31634540
Tachycardia 69.30 10.53 311 60823 75896 31560314
Expired product administered 69.24 10.53 53 61081 3008 31633202
Upper respiratory tract infection 69.03 10.53 166 60968 29256 31606954
Injury associated with device 68.89 10.53 34 61100 866 31635344
Device use issue 68.18 10.53 27 61107 398 31635812
General physical health deterioration 64.74 10.53 74 61060 113361 31522849
Incorrect route of product administration 62.90 10.53 94 61040 11579 31624631
Pain 58.83 10.53 584 60550 186175 31450035
Hypoxic-ischaemic encephalopathy 56.92 10.53 55 61079 4286 31631924
Cardiogenic shock 56.45 10.53 130 61004 22278 31613932
Completed suicide 56.33 10.53 56 61078 91458 31544752
Stress 55.61 10.53 138 60996 24803 31611407
Angioedema 54.98 10.53 166 60968 33452 31602758
Infusion site erythema 54.86 10.53 38 61096 1845 31634365
Injection site injury 51.66 10.53 19 61115 226 31635984
Unresponsive to stimuli 51.57 10.53 137 60997 25663 31610547
COVID-19 51.53 10.53 226 60908 54595 31581615
Kounis syndrome 51.39 10.53 38 61096 2046 31634164
Pulse absent 50.52 10.53 57 61077 5320 31630890
Sinus tachycardia 50.32 10.53 101 61033 15748 31620462
Interstitial lung disease 47.30 10.53 30 61104 61373 31574837
Electrocardiogram QRS complex prolonged 47.03 10.53 49 61085 4180 31632030
Rheumatoid arthritis 46.51 10.53 17 61117 47792 31588418
Anaemia 46.38 10.53 233 60901 213289 31422921
Decreased appetite 44.66 10.53 149 60985 153068 31483142
Metabolic acidosis 44.14 10.53 172 60962 39405 31596805
Infusion site pruritus 43.88 10.53 22 61112 580 31635630
Psoriasis 43.16 10.53 18 61116 46701 31589509
Endophthalmitis 42.20 10.53 43 61091 3573 31632637
Haemodynamic instability 40.52 10.53 65 61069 8510 31627700
Accidental overdose 40.34 10.53 101 61033 18249 31617961
Disease progression 39.73 10.53 71 61063 90393 31545817
Multiple organ dysfunction syndrome 39.65 10.53 246 60888 67957 31568253
Wrong product administered 38.94 10.53 48 61086 4920 31631290
Corneal reflex decreased 38.89 10.53 14 61120 156 31636054
Injection site coldness 38.48 10.53 9 61125 15 31636195
Generalised tonic-clonic seizure 37.99 10.53 104 61030 19827 31616383
Drug intolerance 37.95 10.53 27 61107 52006 31584204
Hyperthermia malignant 37.69 10.53 31 61103 1953 31634257
Post procedural complication 36.59 10.53 70 61064 10536 31625674
Anaesthetic complication neurological 36.46 10.53 16 61118 309 31635901
Overdose 36.04 10.53 283 60851 84381 31551829
Anxiety 35.88 10.53 299 60835 90734 31545476
Infusion site rash 35.75 10.53 17 61117 398 31635812
Urticaria 35.68 10.53 211 60923 57306 31578904
Mydriasis 35.64 10.53 53 61081 6499 31629711
Ventricular extrasystoles 35.36 10.53 71 61063 11071 31625139
Cardiotoxicity 35.33 10.53 46 61088 4981 31631229
Administration site pain 35.01 10.53 14 61120 212 31635998
Liquid product physical issue 33.83 10.53 16 61118 370 31635840
Acute kidney injury 33.72 10.53 361 60773 279353 31356857
Infusion related reaction 33.57 10.53 182 60952 47873 31588337
Weight decreased 33.30 10.53 177 60957 159775 31476435
Pulseless electrical activity 33.18 10.53 52 61082 6675 31629535
Infusion site nodule 33.15 10.53 11 61123 94 31636116
Hypoxia 32.78 10.53 187 60947 50126 31586084
Respiratory depression 32.04 10.53 80 61054 14430 31621780
Asthenia 31.74 10.53 279 60855 224476 31411734
Delayed recovery from anaesthesia 31.69 10.53 19 61115 718 31635492
Incorrect drug administration rate 31.60 10.53 24 61110 1346 31634864
Leukopenia 31.60 10.53 39 61095 57789 31578421
Procedural haemorrhage 31.52 10.53 30 61104 2294 31633916
Medical device site laceration 31.52 10.53 6 61128 0 31636210
Infusion site bruising 31.37 10.53 17 61117 528 31635682
Hyperdynamic left ventricle 31.19 10.53 12 61122 163 31636047
Neutropenia 30.52 10.53 153 60981 140211 31495999
BRASH syndrome 30.24 10.53 14 61120 308 31635902
Apnoea 30.21 10.53 48 61086 6234 31629976
Death 30.12 10.53 502 60632 360067 31276143
Laryngeal oedema 30.05 10.53 34 61100 3183 31633027
Brain oedema 29.66 10.53 72 61062 12760 31623450
Removal of foreign body 29.45 10.53 7 61127 13 31636197
Eyelid rash 29.41 10.53 8 61126 31 31636179
Corneal oedema 29.20 10.53 22 61112 1219 31634991
Mean arterial pressure decreased 29.10 10.53 11 61123 142 31636068
Infusion site haemorrhage 28.93 10.53 19 61115 844 31635366
Blood pressure decreased 28.91 10.53 175 60959 47916 31588294
Oculocardiac reflex 28.81 10.53 9 61125 62 31636148
Malignant neoplasm progression 28.76 10.53 69 61065 78929 31557281
Retinal artery occlusion 28.74 10.53 25 61109 1701 31634509
Injection site pain 28.25 10.53 137 60997 34497 31601713
Spinal cord infarction 28.08 10.53 13 61121 286 31635924
Respiratory tract infection 28.03 10.53 86 61048 17475 31618735
Cauda equina syndrome 27.91 10.53 15 61119 458 31635752
Toxicity to various agents 27.80 10.53 498 60636 180989 31455221
Injection site hypoaesthesia 27.32 10.53 9 61125 75 31636135
Factor V Leiden mutation 27.21 10.53 9 61125 76 31636134
Hypersensitivity 26.91 10.53 192 60942 55551 31580659
Pancytopenia 26.74 10.53 83 61051 87233 31548977
Electrocardiogram ST segment depression 26.67 10.53 27 61107 2226 31633984
Oedema peripheral 26.67 10.53 115 61019 109724 31526486
Cyanosis 26.22 10.53 65 61069 11670 31624540
Eye infection 25.96 10.53 31 61103 3074 31633136
Hypopyon 25.51 10.53 13 61121 355 31635855
Thrombocytopenia 25.43 10.53 166 60968 142581 31493629
Cardiac failure congestive 25.36 10.53 74 61060 79313 31556897
Melaena 25.07 10.53 16 61118 32638 31603572
Haemoglobin decreased 24.96 10.53 122 61012 112553 31523657
White blood cell count decreased 24.74 10.53 86 61048 87312 31548898
Myocardial stunning 24.63 10.53 6 61128 13 31636197
Diabetes mellitus 23.99 10.53 28 61106 42528 31593682
Trigemino-cardiac reflex 23.79 10.53 10 61124 173 31636037
Device malfunction 23.60 10.53 54 61080 9212 31626998
Administration site swelling 23.59 10.53 10 61124 177 31636033
Systolic anterior motion of mitral valve 23.52 10.53 7 61127 40 31636170
Hyponatraemia 23.42 10.53 69 61065 73730 31562480
Aqueous fibrin 23.23 10.53 7 61127 42 31636168
Multiple allergies 23.19 10.53 26 61108 2409 31633801
Pulmonary oedema 23.08 10.53 156 60978 44346 31591864
Circulatory collapse 22.98 10.53 87 61047 19657 31616553
Respiratory acidosis 22.94 10.53 36 61098 4626 31631584
Dehydration 22.50 10.53 136 60998 118975 31517235
Anal sphincter atony 22.48 10.53 8 61126 86 31636124
Loss of consciousness 22.41 10.53 238 60896 77117 31559093
Tryptase increased 22.29 10.53 10 61124 204 31636006
Coronary artery disease 22.24 10.53 34 61100 46053 31590157
Nasopharyngitis 21.92 10.53 202 60932 63043 31573167
Agranulocytosis 21.62 10.53 7 61127 21240 31614970
Respiratory arrest 21.51 10.53 104 61030 26153 31610057
Embolia cutis medicamentosa 21.39 10.53 10 61124 225 31635985
Croup infectious 21.30 10.53 11 61123 309 31635901
Injection site discolouration 21.26 10.53 19 61115 1340 31634870
Procedural hypotension 21.24 10.53 16 61118 886 31635324
Tubulointerstitial nephritis 20.86 10.53 5 61129 18491 31617719
Infusion site mass 20.71 10.53 11 61123 328 31635882
Hypoglycaemia 20.59 10.53 42 61092 50904 31585306
Swollen tongue 20.54 10.53 63 61071 12799 31623411
Dermatitis atopic 20.48 10.53 35 61099 4827 31631383
Procedural complication 20.48 10.53 32 61102 4097 31632113
Neuromuscular block prolonged 20.07 10.53 12 61122 451 31635759
Administration site erythema 19.94 10.53 7 61127 72 31636138
Skin texture abnormal 19.91 10.53 6 61128 36 31636174
Chondromalacia 19.89 10.53 5 61129 13 31636197
Prostate cancer 19.87 10.53 26 61108 37575 31598635
Coagulation factor deficiency 19.78 10.53 8 61126 125 31636085
Atrioventricular block complete 19.73 10.53 48 61086 8517 31627693
Haematochezia 19.38 10.53 30 61104 40434 31595776
Pupil fixed 19.38 10.53 20 61114 1687 31634523
Dyspnoea exertional 19.37 10.53 28 61106 38809 31597401
Macroglossia 19.29 10.53 11 61123 378 31635832
Bronchopulmonary aspergillosis allergic 19.14 10.53 13 61121 611 31635599
Left ventricle outflow tract obstruction 18.90 10.53 8 61126 141 31636069
Familial periodic paralysis 18.83 10.53 7 61127 86 31636124
Hepatocellular injury 18.79 10.53 9 61125 21535 31614675
Intracranial hypotension 18.61 10.53 9 61125 219 31635991
Injection site extravasation 18.52 10.53 24 61110 2586 31633624
Malaise 18.47 10.53 222 60912 168289 31467921
Headache 18.41 10.53 474 60660 183178 31453032
Platelet count decreased 18.37 10.53 131 61003 110304 31525906
Eyelid oedema 18.11 10.53 33 61101 4787 31631423
Pancreatitis acute 17.74 10.53 14 61120 25586 31610624
Blood pressure fluctuation 17.65 10.53 11 61123 22725 31613485
Phaeochromocytoma crisis 17.61 10.53 6 61128 56 31636154
Anterior chamber cell 17.61 10.53 10 61124 341 31635869
Suicide attempt 17.47 10.53 28 61106 37220 31598990
Abdominal pain 17.27 10.53 189 60945 145763 31490447
Angina pectoris 17.25 10.53 19 61115 29622 31606588
Oxygen saturation decreased 17.08 10.53 157 60977 48958 31587252
Ophthalmoplegia 17.05 10.53 19 61115 1749 31634461
Cardiac arrest neonatal 17.04 10.53 5 61129 27 31636183
Jaundice 16.99 10.53 20 61114 30267 31605943
Reperfusion arrhythmia 16.99 10.53 6 61128 63 31636147
International normalised ratio increased 16.85 10.53 39 61095 45184 31591026
Gastrointestinal haemorrhage 16.79 10.53 92 61042 82457 31553753
Food allergy 16.76 10.53 15 61119 1060 31635150
Vitritis 16.70 10.53 13 61121 756 31635454
Respiratory distress 16.44 10.53 116 61018 33437 31602773
Plasma cell myeloma 16.42 10.53 55 61079 56476 31579734
Myalgia 16.33 10.53 85 61049 77173 31559037
Illness 16.29 10.53 47 61087 9230 31626980
Asthma 16.26 10.53 139 60995 42472 31593738
Intentional self-injury 16.24 10.53 3 61131 13312 31622898
Dry gangrene 16.23 10.53 10 61124 397 31635813
Seizure like phenomena 16.16 10.53 12 61122 650 31635560
Coma 16.11 10.53 135 60999 41015 31595195
Pulmonary fibrosis 16.07 10.53 6 61128 16654 31619556
Catecholamine crisis 16.06 10.53 5 61129 34 31636176
Administration site irritation 16.02 10.53 4 61130 10 31636200
Sinus arrest 15.99 10.53 17 61117 1484 31634726
Blood lactic acid increased 15.91 10.53 36 61098 6094 31630116
Cholestasis 15.81 10.53 15 61119 25060 31611150
Product adhesion issue 15.77 10.53 17 61117 1508 31634702
Administration site scar 15.76 10.53 3 61131 0 31636210
Deep vein thrombosis 15.72 10.53 62 61072 60674 31575536
Areflexia 15.63 10.53 23 61111 2793 31633417
Paralysis 15.54 10.53 34 61100 5629 31630581
Vitreous floaters 15.53 10.53 25 61109 3282 31632928
COVID-19 immunisation 15.48 10.53 8 61126 225 31635985
Cytomegalovirus infection 15.32 10.53 15 61119 24692 31611518
Brain stem syndrome 15.23 10.53 10 61124 444 31635766
Hepatotoxicity 15.20 10.53 9 61125 19117 31617093
Musculoskeletal stiffness 15.11 10.53 36 61098 41289 31594921
Injury corneal 15.02 10.53 4 61130 14 31636196
Anion gap 15.02 10.53 12 61122 725 31635485
Vitreous disorder 14.94 10.53 6 61128 92 31636118
Neuromuscular blockade 14.89 10.53 8 61126 244 31635966
Drug-induced liver injury 14.87 10.53 15 61119 24348 31611862
Paraplegia 14.87 10.53 22 61112 2685 31633525
Insurance issue 14.83 10.53 15 61119 1235 31634975
Bladder cancer 14.72 10.53 5 61129 14720 31621490
Paraesthesia oral 14.71 10.53 26 61108 3682 31632528
Throat tightness 14.59 10.53 40 61094 7629 31628581
Respiratory tract infection bacterial 14.56 10.53 16 61118 1450 31634760
Electrocardiogram T wave amplitude increased 14.55 10.53 5 61129 48 31636162
Fatigue 14.53 10.53 515 60619 334691 31301519
Transient ischaemic attack 14.47 10.53 15 61119 24041 31612169
Allergy to arthropod sting 14.46 10.53 5 61129 49 31636161
Recalled product administered 14.43 10.53 10 61124 486 31635724
Accelerated idioventricular rhythm 14.37 10.53 6 61128 102 31636108
Pallor 14.37 10.53 83 61051 22341 31613869
Blindness 14.35 10.53 55 61079 12496 31623714
Skin infection 14.28 10.53 37 61097 6826 31629384
Stridor 14.24 10.53 20 61114 2327 31633883
Myocardial infarction 14.19 10.53 145 60989 113309 31522901
Haematuria 14.19 10.53 44 61090 46270 31589940
Hepatitis 14.15 10.53 13 61121 22053 31614157
Myopathy toxic 14.14 10.53 10 61124 502 31635708
Retinal vasculitis 14.09 10.53 9 61125 381 31635829
Pharyngeal oedema 13.91 10.53 33 61101 5763 31630447
Tracheitis 13.89 10.53 11 61123 656 31635554
Administration site pruritus 13.72 10.53 4 61130 21 31636189
End-tidal CO2 decreased 13.69 10.53 3 61131 3 31636207
Electrocardiogram ST-T segment depression 13.69 10.53 3 61131 3 31636207
General anaesthesia 13.69 10.53 3 61131 3 31636207
Drug resistance 13.68 10.53 15 61119 23438 31612772
Bronchitis 13.58 10.53 124 61010 38593 31597617
Foreign body 13.56 10.53 13 61121 1003 31635207
Alopecia 13.50 10.53 12 61122 20683 31615527
Respiratory tract infection viral 13.49 10.53 18 61116 1996 31634214
Corneal opacity 13.48 10.53 10 61124 541 31635669
Orthostatic hypotension 13.45 10.53 16 61118 24103 31612107
Eosinophilia 13.43 10.53 15 61119 23238 31612972
Administration site reaction 13.34 10.53 5 61129 63 31636147
Cardiac failure 13.32 10.53 104 61030 85849 31550361
Gas gangrene 13.27 10.53 5 61129 64 31636146
Injection site joint infection 13.14 10.53 4 61130 25 31636185
Pharyngeal swelling 13.12 10.53 17 61117 1832 31634378
Infusion site irritation 13.05 10.53 7 61127 213 31635997
Product administered at inappropriate site 13.04 10.53 17 61117 1843 31634367
Ventricular arrhythmia 13.01 10.53 29 61105 4862 31631348
Coagulation factor V level abnormal 13.00 10.53 4 61130 26 31636184
Rectal haemorrhage 12.97 10.53 32 61102 36272 31599938
Neoplasm progression 12.93 10.53 12 61122 20260 31615950
Pupillary reflex impaired 12.90 10.53 15 61119 1446 31634764
Gait disturbance 12.85 10.53 92 61042 77403 31558807
Insomnia 12.79 10.53 119 61015 94717 31541493
Mouth swelling 12.75 10.53 16 61118 1670 31634540
Intestinal haematoma 12.61 10.53 5 61129 74 31636136
Seasonal allergy 12.53 10.53 31 61103 5557 31630653
Drug interaction 12.36 10.53 307 60827 208236 31427974
Blood creatinine increased 12.35 10.53 111 61023 88967 31547243
Hyperaesthesia 12.32 10.53 25 61109 3926 31632284
Compartment syndrome 12.28 10.53 20 61114 2651 31633559
Nodal rhythm 12.23 10.53 14 61120 1327 31634883
Gastroenteritis viral 12.20 10.53 33 61101 6244 31629966
Administration related reaction 12.14 10.53 5 61129 82 31636128
Gamma-glutamyltransferase increased 12.06 10.53 22 61112 27803 31608407
Anaphylactoid shock 12.05 10.53 8 61126 362 31635848
Polyneuropathy 12.05 10.53 5 61129 13017 31623193
Visual acuity reduced 12.01 10.53 60 61074 15283 31620927
Non-infectious endophthalmitis 12.01 10.53 6 61128 157 31636053
Wheezing 11.99 10.53 114 61020 35872 31600338
Myelosuppression 11.88 10.53 7 61127 14913 31621297
Laryngeal stenosis 11.87 10.53 5 61129 87 31636123
Myokymia 11.87 10.53 5 61129 87 31636123
Constipation 11.86 10.53 168 60966 123823 31512387
Infusion site reaction 11.80 10.53 11 61123 819 31635391
Optic nerve injury 11.77 10.53 5 61129 89 31636121
Quadriplegia 11.72 10.53 15 61119 1596 31634614
Alanine aminotransferase increased 11.72 10.53 90 61044 74566 31561644
Heart rate increased 11.67 10.53 126 61008 40984 31595226
Mobility decreased 11.65 10.53 22 61112 27447 31608763
Burkholderia test positive 11.65 10.53 12 61122 1010 31635200
Infusion site vesicles 11.57 10.53 6 61128 170 31636040
Liver function test abnormal 11.55 10.53 25 61109 29667 31606543
Apgar score low 11.43 10.53 11 61123 853 31635357
Pneumocystis jirovecii pneumonia 11.41 10.53 11 61123 18240 31617970
Eye inflammation 11.36 10.53 16 61118 1867 31634343
Torsade de pointes 11.35 10.53 34 61100 6816 31629394
Seizure 11.33 10.53 262 60872 99506 31536704
Product dose omission issue 11.30 10.53 275 60859 105311 31530899
Device issue 11.24 10.53 39 61095 8445 31627765
Oral lichen planus 11.23 10.53 6 61128 181 31636029
Nephropathy toxic 11.10 10.53 4 61130 11349 31624861
Drug reaction with eosinophilia and systemic symptoms 11.09 10.53 26 61108 29992 31606218
Hallucination 11.00 10.53 49 61085 46361 31589849
Retinal vascular occlusion 10.99 10.53 6 61128 189 31636021
Status asthmaticus 10.95 10.53 7 61127 297 31635913
Spinal cord oedema 10.88 10.53 6 61128 193 31636017
Disease recurrence 10.82 10.53 12 61122 18649 31617561
Penile vascular disorder 10.76 10.53 3 61131 13 31636197
Liver disorder 10.76 10.53 26 61108 29681 31606529
Product distribution issue 10.69 10.53 8 61126 439 31635771
Posterior capsule rupture 10.58 10.53 3 61131 14 31636196
Multiple sclerosis relapse 10.56 10.53 5 61129 12042 31624168
Bone marrow failure 10.56 10.53 24 61110 27984 31608226
Pharyngitis streptococcal 10.54 10.53 17 61117 2236 31633974

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
Anaphylactic reaction 876.08 9.55 891 135858 74083 70717612
Cardiac arrest 601.23 9.55 1093 135656 158741 70632954
Local anaesthetic systemic toxicity 562.84 9.55 158 136591 707 70790988
Stress cardiomyopathy 552.42 9.55 302 136447 9560 70782135
Toxic anterior segment syndrome 521.86 9.55 195 136554 2435 70789260
Anaesthetic complication 496.02 9.55 188 136561 2448 70789247
Anaphylactic shock 476.98 9.55 438 136311 32052 70759643
Hereditary angioedema 363.39 9.55 183 136566 4876 70786819
Device failure 347.17 9.55 186 136563 5649 70786046
Chondrolysis 330.88 9.55 86 136663 267 70791428
Ventricular tachycardia 297.29 9.55 359 136390 36064 70755631
Hypotension 289.37 9.55 1539 135210 402842 70388853
Rheumatoid arthritis 262.59 9.55 117 136632 291688 70500007
Drug ineffective 245.43 9.55 2825 133924 936927 69854768
Fear 225.98 9.55 238 136511 20573 70771122
Sinusitis 224.32 9.55 777 135972 168418 70623277
Lagophthalmos 211.99 9.55 63 136686 358 70791337
Bradycardia 211.41 9.55 623 136126 123992 70667703
Renal injury 203.81 9.55 200 136549 15894 70775801
Drug intolerance 189.97 9.55 99 136650 225588 70566107
Completed suicide 187.71 9.55 102 136647 227033 70564662
Shock 183.83 9.55 301 136448 40124 70751571
Pulseless electrical activity 178.21 9.55 170 136579 13045 70778650
Bronchospasm 176.81 9.55 219 136530 22573 70769122
Ventricular fibrillation 175.17 9.55 238 136511 26873 70764822
Incorrect route of product administration 171.83 9.55 233 136516 26259 70765436
Anhedonia 171.42 9.55 172 136577 14041 70777654
Kounis syndrome 170.66 9.55 97 136652 3314 70788381
Methaemoglobinaemia 159.60 9.55 105 136644 4681 70787014
Joint swelling 156.92 9.55 154 136595 253057 70538638
Contraindicated product administered 156.61 9.55 34 136715 134578 70657117
Synovitis 155.82 9.55 30 136719 129198 70662497
Unevaluable event 149.24 9.55 318 136431 51745 70739950
Accidental exposure to product 148.52 9.55 224 136525 27827 70763868
General physical health deterioration 146.89 9.55 143 136606 235888 70555807
Cardiogenic shock 143.49 9.55 254 136495 36053 70755642
Emotional distress 142.91 9.55 257 136492 36931 70754764
Hand deformity 140.88 9.55 6 136743 86476 70705219
Product quality issue 139.54 9.55 228 136521 30333 70761362
Angioedema 137.64 9.55 358 136391 66252 70725443
Injury 136.19 9.55 352 136397 64893 70726802
Pemphigus 134.48 9.55 6 136743 83030 70708665
Tachycardia 130.95 9.55 629 136120 157917 70633778
Electrocardiogram ST segment elevation 130.43 9.55 112 136637 7492 70784203
Arteriospasm coronary 129.10 9.55 101 136648 5923 70785772
Hepatic enzyme increased 126.05 9.55 73 136676 156917 70634778
Corneal oedema 125.89 9.55 71 136678 2389 70789306
Urticaria 117.85 9.55 623 136126 162426 70629269
Vasoplegia syndrome 114.48 9.55 73 136676 3083 70788612
Diarrhoea 112.78 9.55 968 135781 782373 70009322
Pericarditis 107.93 9.55 17 136732 84688 70707007
Infusion site swelling 107.75 9.55 92 136657 6106 70785589
Injection site pallor 106.04 9.55 25 136724 44 70791651
Pulse absent 103.60 9.55 108 136641 9222 70782473
Glossodynia 102.31 9.55 21 136728 86466 70705229
Endophthalmitis 100.97 9.55 89 136660 6166 70785529
Left ventricle outflow tract obstruction 100.72 9.55 34 136715 308 70791387
Systemic lupus erythematosus 99.47 9.55 36 136713 101866 70689829
Maternal exposure during delivery 98.44 9.55 45 136704 961 70790734
Infusion site extravasation 96.73 9.55 97 136652 7911 70783784
Drug ineffective for unapproved indication 96.47 9.55 223 136526 38315 70753380
COVID-19 96.44 9.55 432 136317 105325 70686370
Unresponsive to stimuli 96.10 9.55 268 136481 51663 70740032
Haemodynamic instability 95.94 9.55 134 136615 15524 70776171
Generalised tonic-clonic seizure 95.55 9.55 233 136516 41428 70750267
Cauda equina syndrome 95.32 9.55 47 136702 1195 70790500
Sinus tachycardia 94.72 9.55 205 136544 33708 70757987
Infusion site erythema 94.21 9.55 93 136656 7442 70784253
Arthropathy 90.90 9.55 93 136656 149964 70641731
Stridor 89.58 9.55 76 136673 5000 70786695
Arthralgia 87.41 9.55 590 136159 502800 70288895
Injury associated with device 85.93 9.55 60 136689 2952 70788743
Infusion site pain 84.72 9.55 108 136641 11456 70780239
Alopecia 82.47 9.55 161 136588 198329 70593366
Needle issue 81.64 9.55 103 136646 10812 70780883
Helicobacter infection 81.23 9.55 7 136742 55649 70736046
Infusion site pruritus 79.79 9.55 59 136690 3178 70788517
Abdominal discomfort 79.29 9.55 186 136563 214472 70577223
Injection site ischaemia 78.26 9.55 16 136733 7 70791688
Pulmonary oedema 77.19 9.55 339 136410 81939 70709756
Hypopyon 76.85 9.55 39 136710 1056 70790639
Anaesthetic complication neurological 76.72 9.55 32 136717 543 70791152
Wrong product administered 75.89 9.55 87 136662 8264 70783431
Therapeutic product effect decreased 74.42 9.55 100 136649 142918 70648777
Expired product administered 74.39 9.55 76 136673 6337 70785358
Accidental exposure to product by child 73.37 9.55 53 136696 2753 70788942
Upper respiratory tract infection 73.14 9.55 325 136424 78949 70712746
Electrocardiogram ST segment depression 72.69 9.55 64 136685 4427 70787268
Ear infection 69.86 9.55 163 136586 28173 70763522
Decreased appetite 69.79 9.55 326 136423 304454 70487241
Post procedural complication 69.27 9.55 140 136609 21941 70769754
Stress 69.13 9.55 287 136462 67679 70724016
Injection site laceration 67.69 9.55 20 136729 111 70791584
Procedural hypotension 67.67 9.55 44 136705 1922 70789773
Wound 67.14 9.55 55 136694 98677 70693018
Circulatory collapse 66.54 9.55 184 136565 35290 70756405
Musculoskeletal stiffness 65.67 9.55 115 136634 147645 70644050
Impaired quality of life 64.89 9.55 83 136666 8833 70782862
Acute kidney injury 64.77 9.55 594 136155 474030 70317665
Neutropenia 63.74 9.55 267 136482 256889 70534806
Anxiety 63.56 9.55 677 136072 219653 70572042
Blood pressure decreased 62.89 9.55 345 136404 91170 70700525
Hyponatraemia 62.12 9.55 135 136614 159952 70631743
Anaemia 61.69 9.55 490 136259 402933 70388762
Injection site injury 61.35 9.55 29 136720 670 70791025
Accidental overdose 60.83 9.55 177 136572 34944 70756751
Psoriasis 60.75 9.55 60 136689 98373 70693322
Metabolic acidosis 59.91 9.55 293 136456 74053 70717642
Tryptase increased 59.61 9.55 27 136722 564 70791131
Lower respiratory tract infection 59.50 9.55 77 136672 111836 70679859
Airway peak pressure increased 59.10 9.55 23 136726 323 70791372
Asthenia 58.93 9.55 581 136168 457085 70334610
Mydriasis 57.47 9.55 108 136641 16045 70775650
Retinal artery occlusion 57.18 9.55 47 136702 2959 70788736
Bronchitis 56.76 9.55 404 136345 116839 70674856
Cyanosis 56.67 9.55 133 136616 23073 70768622
Hypoxic-ischaemic encephalopathy 56.32 9.55 70 136679 7238 70784457
Eyelid rash 56.14 9.55 17 136732 104 70791591
Infusion site bruising 55.62 9.55 39 136710 1932 70789763
Multiple organ dysfunction syndrome 55.51 9.55 379 136370 108136 70683559
Folliculitis 55.47 9.55 8 136741 42562 70749133
Overdose 55.37 9.55 535 136214 169210 70622485
Incorrect drug administration rate 55.23 9.55 47 136702 3105 70788590
Swollen tongue 55.10 9.55 177 136572 36869 70754826
Removal of foreign body 54.40 9.55 13 136736 25 70791670
Electrocardiogram QRS complex prolonged 54.32 9.55 80 136669 9726 70781969
Disease progression 53.73 9.55 141 136608 156531 70635164
Peripheral ischaemia 53.73 9.55 75 136674 8683 70783012
Sleep disorder due to general medical condition, insomnia type 53.52 9.55 4 136745 35728 70755967
Hyperaesthesia 53.18 9.55 84 136665 10858 70780837
Extradural abscess 53.05 9.55 32 136717 1223 70790472
Injection site coldness 52.96 9.55 16 136733 97 70791598
Vitritis 52.20 9.55 35 136714 1611 70790084
Infusion site mass 51.84 9.55 31 136718 1166 70790529
Cataract operation complication 51.77 9.55 20 136729 275 70791420
Embolia cutis medicamentosa 51.68 9.55 24 136725 532 70791163
Psoriatic arthropathy 50.72 9.55 31 136718 64740 70726955
Muscle injury 50.71 9.55 7 136742 38487 70753208
Body tinea 50.19 9.55 32 136717 1351 70790344
Ophthalmoplegia 49.37 9.55 42 136707 2773 70788922
Seizure 49.07 9.55 542 136207 177420 70614275
Extradural haematoma 48.76 9.55 41 136708 2664 70789031
Anterior chamber cell 48.71 9.55 27 136722 878 70790817
Ventricular extrasystoles 48.42 9.55 108 136641 18118 70773577
Illness 48.29 9.55 153 136596 31638 70760057
Interstitial lung disease 47.85 9.55 80 136669 104605 70687090
Lip swelling 47.32 9.55 159 136590 33895 70757800
COVID-19 immunisation 46.90 9.55 28 136721 1050 70790645
Respiratory depression 46.77 9.55 129 136620 24702 70766993
Asthma 46.68 9.55 395 136354 120398 70671297
Hypoxia 46.55 9.55 324 136425 93020 70698675
Leukopenia 46.37 9.55 84 136665 106476 70685219
Intentional self-injury 46.13 9.55 4 136745 31646 70760049
Respiratory acidosis 45.97 9.55 76 136673 10205 70781490
Mobility decreased 45.90 9.55 80 136669 102919 70688776
Status asthmaticus 45.67 9.55 27 136722 994 70790701
Pancytopenia 45.24 9.55 145 136604 150962 70640733
Loss of consciousness 45.12 9.55 479 136270 155237 70636458
Malignant neoplasm progression 44.51 9.55 106 136643 121633 70670062
Apnoea 44.49 9.55 77 136672 10732 70780963
C-reactive protein abnormal 44.33 9.55 10 136739 38569 70753126
Spinal cord infarction 44.13 9.55 22 136727 573 70791122
Neuromuscular block prolonged 43.99 9.55 26 136723 957 70790738
Mean arterial pressure decreased 43.98 9.55 19 136730 353 70791342
Trigemino-cardiac reflex 43.66 9.55 17 136732 239 70791456
Hypoaesthesia oral 43.46 9.55 82 136667 12218 70779477
Cholestasis 43.29 9.55 19 136730 47853 70743842
Pharyngeal oedema 42.82 9.55 94 136655 15602 70776093
Procedural complication 42.64 9.55 62 136687 7452 70784243
Device use issue 42.53 9.55 35 136714 2207 70789488
Paralysis 42.06 9.55 80 136669 11992 70779703
Aqueous fibrin 41.85 9.55 14 136735 123 70791572
Systolic anterior motion of mitral valve 41.82 9.55 12 136737 59 70791636
Infusion site haemorrhage 41.39 9.55 38 136711 2777 70788918
Ventricular hypokinesia 41.24 9.55 64 136685 8148 70783547
Thrombocytopenia 41.01 9.55 281 136468 238829 70552866
Impaired healing 40.75 9.55 50 136699 74324 70717371
Respiratory tract infection 39.99 9.55 175 136574 42223 70749472
Laryngeal oedema 39.88 9.55 60 136689 7435 70784260
Delayed recovery from anaesthesia 39.78 9.55 29 136720 1528 70790167
Nerve root injury 39.77 9.55 10 136739 26 70791669
Hyperthermia malignant 39.27 9.55 36 136713 2625 70789070
Paraplegia 39.19 9.55 47 136702 4683 70787012
Product adhesion issue 38.93 9.55 35 136714 2489 70789206
Myopathy toxic 38.67 9.55 24 136725 966 70790729
Multiple allergies 38.30 9.55 60 136689 7700 70783995
Retinal vasculitis 38.22 9.55 26 136723 1226 70790469
Procedural haemorrhage 38.02 9.55 45 136704 4422 70787273
Cardiac failure congestive 37.80 9.55 134 136615 135323 70656372
Injection site hypoaesthesia 37.80 9.55 18 136731 423 70791272
Toxicity to various agents 37.70 9.55 984 135765 381188 70410507
Orthostatic hypotension 37.49 9.55 27 136722 51716 70739979
Hyperdynamic left ventricle 37.49 9.55 17 136732 356 70791339
Drug reaction with eosinophilia and systemic symptoms 37.38 9.55 34 136715 57979 70733716
Medical device site laceration 36.77 9.55 7 136742 0 70791695
Throat tightness 36.71 9.55 119 136630 24903 70766792
Anaphylactoid shock 36.28 9.55 21 136728 743 70790952
Bladder prolapse 35.59 9.55 25 136724 1242 70790453
Respiratory distress 35.52 9.55 203 136546 54447 70737248
Nerve block 35.37 9.55 19 136730 580 70791115
Fear of eating 35.26 9.55 17 136732 411 70791284
Blood creatinine increased 35.07 9.55 149 136600 142852 70648843
Type 2 diabetes mellitus 34.64 9.55 21 136728 44059 70747636
Cardiotoxicity 34.50 9.55 70 136679 11000 70780695
Infusion site urticaria 34.36 9.55 21 136728 822 70790873
Chondromalacia 34.31 9.55 13 136736 169 70791526
Haematochezia 34.19 9.55 55 136694 73026 70718669
Anaphylactoid reaction 33.93 9.55 45 136704 4962 70786733
Anal sphincter atony 33.26 9.55 15 136734 310 70791385
Phrenic nerve paralysis 33.26 9.55 15 136734 310 70791385
Product contamination microbial 33.01 9.55 21 136728 883 70790812
Paraesthesia oral 33 9.55 84 136665 15333 70776362
Blood lactic acid increased 32.88 9.55 69 136680 11104 70780591
Troponin I increased 32.70 9.55 40 136709 4068 70787627
Seasonal allergy 32.62 9.55 77 136672 13407 70778288
Gas gangrene 32.61 9.55 14 136735 256 70791439
Infection susceptibility increased 32.42 9.55 34 136715 2923 70788772
Corneal reflex decreased 32.16 9.55 15 136734 336 70791359
Oedema peripheral 32.11 9.55 283 136466 227808 70563887
Blindness 31.87 9.55 108 136641 23119 70768576
Uterine hypertonus 31.83 9.55 14 136735 272 70791423
Hepatotoxicity 31.81 9.55 23 136726 43963 70747732
Meningitis chemical 31.81 9.55 13 136736 209 70791486
Blood cholesterol increased 31.77 9.55 47 136702 64557 70727138
Confusional state 31.34 9.55 374 136375 284024 70507671
Peripheral swelling 30.93 9.55 299 136450 236264 70555431
Type I hypersensitivity 30.79 9.55 37 136712 3695 70788000
Treatment failure 30.74 9.55 158 136591 143984 70647711
Peripheral nerve injury 30.64 9.55 18 136731 655 70791040
Drug resistance 30.29 9.55 18 136731 38172 70753523
Fatigue 30.26 9.55 1291 135458 823028 69968667
Abdominal pain upper 30.06 9.55 234 136515 193368 70598327
Visual acuity reduced 30.02 9.55 120 136629 27810 70763885
C-reactive protein increased 29.73 9.55 111 136638 110406 70681289
Hepatocellular injury 29.71 9.55 27 136722 46064 70745631
Melaena 29.71 9.55 39 136710 56316 70735379
Pharyngeal swelling 29.26 9.55 48 136701 6405 70785290
Platelet aggregation inhibition 29.24 9.55 11 136738 140 70791555
Supraventricular tachycardia 29.15 9.55 94 136655 19616 70772079
Liver injury 28.97 9.55 22 136727 41013 70750682
Oculocardiac reflex 28.81 9.55 9 136740 62 70791633
Death 28.52 9.55 757 135992 509304 70282391
Myocardial ischaemia 28.48 9.55 107 136642 24093 70767602
Migraine 28.30 9.55 237 136512 72001 70719694
Abdominal pain 28.12 9.55 477 136272 341650 70450045
Eye infection 28.06 9.55 61 136688 10057 70781638
Tracheal deviation 27.91 9.55 11 136738 160 70791535
Weight decreased 27.81 9.55 426 136323 310062 70481633
Electrocardiogram T wave inversion 27.80 9.55 41 136708 4990 70786705
Liver disorder 27.26 9.55 48 136701 61520 70730175
Pupil fixed 27.10 9.55 33 136716 3341 70788354
Tubulointerstitial nephritis 27.07 9.55 15 136734 33061 70758634
Blood pH decreased 26.96 9.55 38 136711 4438 70787257
Vasospasm 26.69 9.55 19 136730 964 70790731
Respiratory failure 26.50 9.55 465 136284 168270 70623425
White blood cell count decreased 26.25 9.55 206 136543 169935 70621760
Upper airway obstruction 26.20 9.55 21 136728 1275 70790420
Jaundice 26.09 9.55 35 136714 50073 70741622
Dry gangrene 26.04 9.55 18 136731 871 70790824
Wheezing 26.02 9.55 287 136462 93883 70697812
Atrioventricular block complete 25.85 9.55 76 136673 15087 70776608
Infusion site rash 25.70 9.55 21 136728 1311 70790384
Spinal stroke 25.56 9.55 7 136742 28 70791667
Food allergy 25.50 9.55 53 136696 8471 70783224
Sensory loss 25.26 9.55 63 136686 11356 70780339
Corneal epithelium defect 25.00 9.55 16 136733 680 70791015
Product administration error 24.96 9.55 118 136631 29405 70762290
Harlequin syndrome 24.91 9.55 8 136741 61 70791634
Axillary nerve injury 24.63 9.55 6 136743 13 70791682
Familial periodic paralysis 24.45 9.55 10 136739 161 70791534
Agranulocytosis 24.36 9.55 25 136724 40273 70751422
Spinal anaesthesia 24.25 9.55 8 136741 67 70791628
Liver function test abnormal 24.17 9.55 51 136698 61095 70730600
Constipation 24.11 9.55 342 136407 252096 70539599
Drug abuse 23.79 9.55 176 136573 147080 70644615
Plasma cell myeloma 23.50 9.55 68 136681 73133 70718562
Insurance issue 23.43 9.55 32 136717 3629 70788066
Red blood cell sedimentation rate increased 23.32 9.55 24 136725 38618 70753077
Eosinophilia 23.27 9.55 26 136723 40293 70751402
Distributive shock 23.25 9.55 25 136724 2212 70789483
Vasoconstriction 23.20 9.55 15 136734 649 70791046
PCO2 increased 23.02 9.55 22 136727 1691 70790004
Lung hyperinflation 22.94 9.55 22 136727 1699 70789996
Prostate cancer 22.92 9.55 16 136733 31147 70760548
Propofol infusion syndrome 22.85 9.55 22 136727 1707 70789988
Gastrointestinal haemorrhage 22.79 9.55 163 136586 137245 70654450
Reversible cerebral vasoconstriction syndrome 22.77 9.55 27 136722 2658 70789037
Neuromuscular blockade 22.73 9.55 14 136735 556 70791139
Spinal cord oedema 22.68 9.55 12 136737 355 70791340
Sinus bradycardia 22.65 9.55 98 136651 23525 70768170
Extremity necrosis 22.59 9.55 28 136721 2886 70788809
Compartment syndrome 22.58 9.55 35 136714 4451 70787244
Cytomegalovirus infection 22.55 9.55 26 136723 39732 70751963
Product preparation error 22.49 9.55 35 136714 4467 70787228
Infusion site nodule 22.44 9.55 11 136738 276 70791419
Brain oedema 22.34 9.55 97 136652 23321 70768374
Fall 22.28 9.55 669 136080 443427 70348268
Schizophrenia 22.20 9.55 3 136746 16765 70774930
Status epilepticus 22.19 9.55 100 136649 24426 70767269
Device ineffective 22.17 9.55 9 136740 142 70791553
Diabetes mellitus 22.13 9.55 68 136681 71756 70719939
Obesity 22.11 9.55 12 136737 26759 70764936
Hypoglycaemia 22.11 9.55 100 136649 94264 70697431
Coronary artery disease 21.85 9.55 56 136693 62680 70729015
International normalised ratio increased 21.76 9.55 81 136668 80645 70711050
PO2 decreased 21.76 9.55 27 136722 2787 70788908
Hypercapnia 21.73 9.55 49 136700 8280 70783415
Respiratory arrest 21.69 9.55 178 136571 53755 70737940
Discomfort 21.68 9.55 117 136632 105319 70686376
Rectal prolapse 21.66 9.55 23 136726 2006 70789689
Sleep disorder 21.64 9.55 66 136683 69806 70721889
Ventricular arrhythmia 21.48 9.55 47 136702 7783 70783912
Inappropriate antidiuretic hormone secretion 21.42 9.55 9 136740 23267 70768428
Injection site pain 21.37 9.55 332 136417 117287 70674408
Irritable bowel syndrome 21.31 9.55 41 136708 50809 70740886
BRASH syndrome 21.30 9.55 14 136735 623 70791072
Foreign body 21.27 9.55 26 136723 2642 70789053
Quadriplegia 21.21 9.55 28 136721 3074 70788621
Pancreatitis acute 21.18 9.55 34 136715 45190 70746505
Glucose tolerance impaired 21.16 9.55 43 136706 6763 70784932
Nystagmus 21.10 9.55 52 136697 9303 70782392
Pulmonary fibrosis 21.06 9.55 21 136728 34289 70757406
Inhibitory drug interaction 21.00 9.55 31 136718 3776 70787919
Cardio-respiratory arrest 20.97 9.55 291 136458 100386 70691309
Blister 20.97 9.55 111 136638 100415 70691280
Eyelid oedema 20.95 9.55 63 136686 12664 70779031
Product administered at inappropriate site 20.84 9.55 29 136720 3347 70788348
Pharyngitis streptococcal 20.77 9.55 52 136697 9396 70782299
Fear of death 20.54 9.55 19 136730 1402 70790293
Bursitis infective 20.38 9.55 18 136731 1250 70790445
Ischaemia 20.31 9.55 45 136704 7514 70784181
Pallor 20.28 9.55 142 136607 40832 70750863
Abortion spontaneous 20.27 9.55 13 136736 26466 70765229
Neoplasm progression 20.26 9.55 35 136714 45193 70746502
Heart rate increased 20.20 9.55 302 136447 105846 70685849
Pain in extremity 20.17 9.55 480 136269 327602 70464093
Scar 20.06 9.55 66 136683 13915 70777780
Gastrointestinal disorder 20.05 9.55 120 136629 105307 70686388
Hypercalcaemia 20.03 9.55 22 136727 34363 70757332
Parophthalmia 20.00 9.55 11 136738 352 70791343
Osteonecrosis of jaw 19.99 9.55 30 136719 40972 70750723
Infusion site discomfort 19.97 9.55 16 136733 971 70790724
Arthritis bacterial 19.90 9.55 47 136702 8186 70783509
Eyelid ptosis 19.54 9.55 53 136696 10049 70781646
Neurotoxicity 19.52 9.55 111 136638 29715 70761980
Administration site swelling 19.45 9.55 11 136738 372 70791323
Metastases to liver 19.41 9.55 13 136736 25865 70765830
Ascites 19.39 9.55 66 136683 67481 70724214
Apnoeic attack 19.34 9.55 13 136736 601 70791094
Administration site pain 19.29 9.55 12 136737 485 70791210
Atonic urinary bladder 19.29 9.55 7 136742 80 70791615
Product use issue 19.28 9.55 238 136511 179699 70611996
Intracranial hypotension 19.27 9.55 11 136738 379 70791316
Weight increased 19.21 9.55 340 136409 241991 70549704
Dermatitis atopic 19.20 9.55 49 136700 8958 70782737
Product dose omission issue 19.15 9.55 552 136197 216916 70574779
Injection site inflammation 18.97 9.55 28 136721 3410 70788285
Sinus arrest 18.93 9.55 27 136722 3188 70788507
Aplastic anaemia 18.92 9.55 73 136676 16643 70775052
Drug-induced liver injury 18.84 9.55 51 136698 56062 70735633
Punctate keratitis 18.80 9.55 15 136734 905 70790790
SARS-CoV-2 test false positive 18.78 9.55 4 136745 3 70791692
Stomatitis 18.71 9.55 158 136591 128353 70663342
Liquid product physical issue 18.71 9.55 15 136734 911 70790784
Creatinine renal clearance decreased 18.71 9.55 5 136744 17195 70774500
Pupillary reflex impaired 18.68 9.55 27 136722 3227 70788468
Normal newborn 18.64 9.55 39 136710 6261 70785434
Condition aggravated 18.40 9.55 657 136092 426978 70364717
Progressive multifocal leukoencephalopathy 18.38 9.55 7 136742 19207 70772488
Hypercholesterolaemia 18.36 9.55 6 136743 18111 70773584
Procedural pain 18.27 9.55 76 136673 17933 70773762
Accelerated idioventricular rhythm 18.26 9.55 8 136741 154 70791541
Platelet count decreased 18.25 9.55 238 136511 177984 70613711
Poor quality product administered 18.20 9.55 27 136722 3304 70788391
Rotator cuff syndrome 18.17 9.55 60 136689 12674 70779021
Balance disorder 17.98 9.55 101 136648 90027 70701668
Arterial spasm 17.89 9.55 8 136741 162 70791533
Myelosuppression 17.88 9.55 19 136730 30126 70761569
Disease recurrence 17.87 9.55 28 136721 37575 70754120
Systemic toxicity 17.81 9.55 7 136742 101 70791594
Factor V Leiden mutation 17.80 9.55 8 136741 164 70791531
Depressed mood 17.78 9.55 36 136713 43784 70747911
Dermatitis contact 17.72 9.55 50 136699 9699 70781996
Renal failure 17.50 9.55 483 136266 188587 70603108
Eye inflammation 17.46 9.55 35 136714 5452 70786243
No adverse event 17.45 9.55 114 136635 32039 70759656
Swelling 17.44 9.55 257 136492 188282 70603413
Postpartum disorder 17.36 9.55 4 136745 6 70791689
Torsade de pointes 17.25 9.55 75 136674 18041 70773654
Rheumatoid nodule 17.12 9.55 4 136745 15063 70776632
Gastroenteritis 17.08 9.55 21 136728 31192 70760503
Graft versus host disease 17.05 9.55 4 136745 15019 70776676
Suicide attempt 17.03 9.55 87 136662 79423 70712272
Loss of personal independence in daily activities 17.02 9.55 95 136654 84815 70706880
Brain injury 16.95 9.55 52 136697 10565 70781130
Infection 16.94 9.55 295 136454 210490 70581205
Myocardial stunning 16.92 9.55 8 136741 185 70791510
Amaurosis 16.82 9.55 15 136734 1055 70790640
Pneumocephalus 16.80 9.55 9 136740 273 70791422
Glossoptosis 16.76 9.55 8 136741 189 70791506
Injection site joint infection 16.74 9.55 5 136744 29 70791666
Pneumocystis jirovecii pneumonia 16.71 9.55 20 136729 30062 70761633
Irregular breathing 16.69 9.55 11 136738 492 70791203
Poisoning deliberate 16.69 9.55 6 136743 17054 70774641
Diplopia 16.64 9.55 102 136647 28045 70763650
Monoplegia 16.45 9.55 27 136722 3604 70788091
Laryngospasm 16.38 9.55 27 136722 3616 70788079
Mental status changes 16.38 9.55 190 136559 62911 70728784
Diplegia 16.38 9.55 18 136731 1632 70790063
Gamma-glutamyltransferase increased 16.33 9.55 47 136702 50638 70741057
Epinephrine increased 16.32 9.55 4 136745 9 70791686
Hip arthroplasty 16.27 9.55 18 136731 28022 70763673
Urticaria chronic 16.26 9.55 11 136738 514 70791181
Coagulation factor deficiency 16.21 9.55 7 136742 130 70791565
Diabetes mellitus inadequate control 16.17 9.55 12 136737 22633 70769062
Catecholamine crisis 16.06 9.55 5 136744 34 70791661
Vitamin D increased 16.01 9.55 11 136738 527 70791168
Foot deformity 16.01 9.55 10 136739 20645 70771050
Cardiopulmonary failure 15.93 9.55 37 136712 6373 70785322
Device malfunction 15.93 9.55 76 136673 19008 70772687
Dehydration 15.85 9.55 324 136425 225818 70565877
Phaeochromocytoma crisis 15.84 9.55 9 136740 307 70791388
Inflammation 15.78 9.55 88 136661 78577 70713118
Application site pallor 15.76 9.55 3 136746 0 70791695
Hypercatabolism 15.76 9.55 3 136746 0 70791695
Troponin T increased 15.75 9.55 22 136727 2548 70789147
Blood pressure increased 15.64 9.55 475 136274 188042 70603653
Hepatitis 15.63 9.55 47 136702 49933 70741762
Postresuscitation encephalopathy 15.58 9.55 5 136744 38 70791657
Headache 15.58 9.55 1310 135439 579095 70212600
Pancreatic carcinoma 15.53 9.55 3 136746 12901 70778794
Acute pulmonary oedema 15.53 9.55 59 136690 13353 70778342
Neutropenic sepsis 15.47 9.55 15 136734 24815 70766880
Hepatic cirrhosis 15.46 9.55 22 136727 30709 70760986
Swelling face 15.43 9.55 188 136561 62976 70728719
Retinal vascular occlusion 15.42 9.55 11 136738 560 70791135
Spinal epidural haemorrhage 15.42 9.55 7 136742 147 70791548
Malaise 15.40 9.55 680 136069 432252 70359443
Lung neoplasm malignant 15.35 9.55 15 136734 24727 70766968
Staphylococcal infection 15.32 9.55 164 136585 53240 70738455
Myelodysplastic syndrome 15.31 9.55 21 136728 29764 70761931
Application site alopecia 15.25 9.55 4 136745 13 70791682
Inadequate analgesia 15.21 9.55 28 136721 4094 70787601
Palmar-plantar erythrodysaesthesia syndrome 14.87 9.55 22 136727 30225 70761470
Chest discomfort 14.87 9.55 329 136420 124052 70667643
Neuroleptic malignant syndrome 14.76 9.55 17 136732 25990 70765705
Neurogenic shock 14.74 9.55 11 136738 601 70791094
ECG signs of myocardial ischaemia 14.71 9.55 9 136740 353 70791342
Haemoglobin decreased 14.66 9.55 293 136456 204866 70586829
Capillary nail refill test abnormal 14.65 9.55 5 136744 47 70791648
Blindness cortical 14.63 9.55 13 136736 910 70790785
Exposure during pregnancy 14.58 9.55 244 136505 87473 70704222
Skin test positive 14.50 9.55 14 136735 1090 70790605
Diabetic ketoacidosis 14.47 9.55 24 136725 31488 70760207
Arthritis infective 14.45 9.55 39 136710 7373 70784322
Foetal heart rate abnormal 14.44 9.55 8 136741 260 70791435
Obstructive airways disorder 14.43 9.55 93 136656 26020 70765675
Adverse event 14.42 9.55 48 136701 49413 70742282
Tracheitis 14.34 9.55 15 136734 1286 70790409
Nail bed tenderness 14.22 9.55 9 136740 375 70791320
Product prescribing error 14.16 9.55 34 136715 38918 70752777
Seizure like phenomena 14.14 9.55 17 136732 1698 70789997
Cholestasis of pregnancy 14.09 9.55 13 136736 956 70790739
Radiculopathy 14.06 9.55 34 136715 6011 70785684
Epidural analgesia 14.03 9.55 5 136744 54 70791641
Bone marrow failure 13.99 9.55 48 136701 48962 70742733
Meningitis 13.98 9.55 43 136706 8750 70782945
Respiratory tract infection bacterial 13.97 9.55 17 136732 1720 70789975
Left ventricular dysfunction 13.91 9.55 70 136679 17887 70773808
Incision site rash 13.88 9.55 4 136745 20 70791675
Trigeminal palsy 13.88 9.55 4 136745 20 70791675
Skin ulcer 13.85 9.55 47 136702 48098 70743597
Enzyme induction 13.81 9.55 6 136743 113 70791582
Kidney infection 13.80 9.55 74 136675 19381 70772314
Injection site necrosis 13.79 9.55 15 136734 1344 70790351
Cranial nerve palsies multiple 13.77 9.55 6 136743 114 70791581
Rash 13.75 9.55 825 135924 509737 70281958
Hypomagnesaemia 13.73 9.55 37 136712 40727 70750968
Forced vital capacity abnormal 13.72 9.55 4 136745 21 70791674
Caffeine allergy 13.72 9.55 4 136745 21 70791674
Treatment noncompliance 13.71 9.55 45 136704 46529 70745166
Immune reconstitution inflammatory syndrome 13.71 9.55 4 136745 12986 70778709
Removal of foreign body from throat 13.69 9.55 3 136746 3 70791692
Sinus operation 13.68 9.55 18 136731 1969 70789726
Airway complication of anaesthesia 13.60 9.55 9 136740 405 70791290
Paranasal cyst 13.52 9.55 9 136740 409 70791286
Therapeutic product effect prolonged 13.50 9.55 10 136739 540 70791155
Dry mouth 13.50 9.55 80 136669 70377 70721318
Allodynia 13.49 9.55 15 136734 1378 70790317
Exophthalmos 13.47 9.55 16 136733 1578 70790117
Cardiac assistance device user 13.41 9.55 5 136744 62 70791633
Optic atrophy 13.37 9.55 17 136732 1798 70789897
Vocal cord disorder 13.33 9.55 15 136734 1396 70790299
Skin infection 13.33 9.55 64 136685 16048 70775647
Air embolism 13.31 9.55 9 136740 420 70791275
Alanine aminotransferase increased 13.30 9.55 202 136547 147278 70644417
Pupillary light reflex tests abnormal 13.28 9.55 8 136741 305 70791390
Atrophy of globe 13.27 9.55 5 136744 64 70791631
Pneumonia mycoplasmal 13.24 9.55 15 136734 1406 70790289
Prescribed underdose 13.23 9.55 13 136736 21372 70770323
Post lumbar puncture syndrome 13.21 9.55 11 136738 705 70790990
Hypoventilation 13.20 9.55 35 136714 6547 70785148
Myocardial necrosis marker increased 13.14 9.55 22 136727 2984 70788711
Bundle branch block left 13.09 9.55 47 136702 10352 70781343
Cold sweat 12.95 9.55 66 136683 16950 70774745
Infusion site reaction 12.94 9.55 21 136728 2776 70788919
Vascular resistance systemic decreased 12.90 9.55 7 136742 218 70791477
Peritonitis 12.89 9.55 19 136730 26140 70765555
Optic nerve injury 12.83 9.55 10 136739 583 70791112
Hypocalcaemia 12.76 9.55 44 136705 44815 70746880
Injury corneal 12.73 9.55 5 136744 72 70791623
Ocular retrobulbar haemorrhage 12.72 9.55 6 136743 138 70791557
Vocal cord dysfunction 12.71 9.55 9 136740 453 70791242
Oxygen saturation decreased 12.69 9.55 304 136445 116125 70675570
Chemical burn 12.69 9.55 9 136740 454 70791241
Conjunctival oedema 12.63 9.55 13 136736 1093 70790602
Oxidative stress 12.63 9.55 4 136745 29 70791666
Eye infection intraocular 12.51 9.55 4 136745 30 70791665
Cardiac failure 12.47 9.55 198 136551 143343 70648352
Product contamination 12.47 9.55 13 136736 1110 70790585
Macroglossia 12.39 9.55 13 136736 1118 70790577
Mania 12.39 9.55 9 136740 17165 70774530
Respiratory tract oedema 12.34 9.55 11 136738 773 70790922
Foreign body in respiratory tract 12.31 9.55 8 136741 349 70791346
Injection site extravasation 12.29 9.55 41 136708 8705 70782990
Central venous catheter removal 12.27 9.55 9 136740 479 70791216
Lung disorder 12.22 9.55 81 136668 69403 70722292
Poor quality sleep 12.19 9.55 74 136675 20275 70771420
Nodal rhythm 12.17 9.55 21 136728 2920 70788775
Gait disturbance 12.15 9.55 268 136481 184838 70606857
Vitreous disorder 12.14 9.55 7 136742 246 70791449
Spinal epidural haematoma 12.13 9.55 14 136735 1339 70790356
Areflexia 12.12 9.55 29 136720 5093 70786602
Anal ulcer 12.10 9.55 13 136736 1149 70790546
Erythema 12.09 9.55 485 136264 199078 70592617
Oral herpes 12.08 9.55 84 136665 24102 70767593
Product preparation issue 12.07 9.55 12 136737 968 70790727
End-tidal CO2 decreased 12.07 9.55 4 136745 34 70791661
Abnormal behaviour 12.07 9.55 31 136718 34678 70757017
Streptococcal infection 12.06 9.55 38 136711 7833 70783862
Product use in unapproved indication 12.06 9.55 502 136247 206976 70584719
Chills 12.05 9.55 365 136384 144421 70647274
Infusion site irritation 11.88 9.55 9 136740 503 70791192
Intra-ocular injection complication 11.87 9.55 4 136745 36 70791659
Intraocular pressure increased 11.87 9.55 41 136708 8860 70782835
Autonomic nervous system imbalance 11.85 9.55 26 136723 4313 70787382
Tongue pruritus 11.83 9.55 9 136740 506 70791189
Malignant melanoma 11.82 9.55 6 136743 13894 70777801
Vitreous floaters 11.81 9.55 34 136715 6670 70785025
Injection site atrophy 11.80 9.55 8 136741 375 70791320
Transient ischaemic attack 11.80 9.55 47 136702 45897 70745798
Renal cancer 11.79 9.55 4 136745 11792 70779903
Depression 11.69 9.55 293 136456 198681 70593014
Photosensitivity reaction 11.69 9.55 12 136737 19328 70772367
Retinal haemorrhage 11.61 9.55 37 136712 7673 70784022
Opisthotonus 11.60 9.55 10 136739 672 70791023
Dermatitis exfoliative 11.60 9.55 3 136746 10548 70781147
Post transplant lymphoproliferative disorder 11.59 9.55 3 136746 10542 70781153
SARS-CoV-2 test positive 11.54 9.55 40 136709 8661 70783034
Thermal burn 11.53 9.55 33 136716 6453 70785242
Blood creatine phosphokinase increased 11.50 9.55 70 136679 61193 70730502
Hallucination, auditory 11.50 9.55 11 136738 18317 70773378
Femoral nerve injury 11.50 9.55 4 136745 40 70791655
Anaphylactoid syndrome of pregnancy 11.50 9.55 4 136745 40 70791655
Angina pectoris 11.50 9.55 51 136698 48332 70743363
Breast cancer female 11.49 9.55 3 136746 10483 70781212
Hepatitis cholestatic 11.47 9.55 5 136744 12645 70779050
Procedural anxiety 11.45 9.55 10 136739 684 70791011
Muscle tightness 11.43 9.55 49 136700 11713 70779982
Colour blindness 11.41 9.55 8 136741 396 70791299
Myocardial infarction 11.41 9.55 248 136501 171397 70620298
Cholangitis 11.40 9.55 4 136745 11545 70780150
XIIth nerve injury 11.38 9.55 3 136746 10 70791685
Coagulation factor V level abnormal 11.32 9.55 4 136745 42 70791653
Local reaction 11.31 9.55 9 136740 541 70791154
Post procedural haemorrhage 11.30 9.55 52 136697 12814 70778881
Extrasystoles 11.29 9.55 34 136715 6840 70784855
Colitis ulcerative 11.26 9.55 31 136718 33892 70757803
Cognitive disorder 11.26 9.55 70 136679 60886 70730809
Bladder cancer 11.23 9.55 10 136739 17232 70774463
Quadriparesis 11.21 9.55 21 136728 3112 70788583
Reperfusion arrhythmia 11.21 9.55 7 136742 285 70791410
Proteinuria 11.19 9.55 25 136724 29349 70762346
Intentional product misuse to child 11.19 9.55 5 136744 101 70791594
Insomnia 11.17 9.55 327 136422 217479 70574216
Electrocardiogram ST-T segment depression 11.16 9.55 3 136746 11 70791684
Polyneuropathy 11.10 9.55 15 136734 21400 70770295
Fluid retention 11.09 9.55 74 136675 63311 70728384
Symblepharon 11.08 9.55 6 136743 186 70791509
Gait inability 11.04 9.55 50 136699 47125 70744570
Disseminated intravascular coagulation 10.99 9.55 106 136643 33492 70758203
Retinal ischaemia 10.97 9.55 10 136739 724 70790971
Rectal haemorrhage 10.96 9.55 78 136671 65753 70725942
Administration site discolouration 10.95 9.55 3 136746 12 70791683
Infusion site scar 10.93 9.55 7 136742 298 70791397
Limb injury 10.90 9.55 86 136663 25666 70766029
Oropharyngeal discomfort 10.87 9.55 31 136718 6048 70785647
Unwanted awareness during anaesthesia 10.82 9.55 7 136742 303 70791392
Blood pressure fluctuation 10.78 9.55 68 136681 58944 70732751
Product measured potency issue 10.77 9.55 6 136743 197 70791498
Victim of spousal abuse 10.76 9.55 3 136746 13 70791682
Myopathy 10.74 9.55 12 136737 18600 70773095
Electrocardiogram P wave abnormal 10.74 9.55 7 136742 307 70791388
Pain in jaw 10.74 9.55 44 136705 42625 70749070
Body dysmorphic disorder 10.70 9.55 7 136742 309 70791386
Flushing 10.68 9.55 220 136529 81952 70709743
Heparin-induced thrombocytopenia 10.67 9.55 40 136709 8997 70782698
Hyperkalaemia 10.66 9.55 143 136606 106448 70685247
Concomitant disease aggravated 10.65 9.55 5 136744 12109 70779586
Bradyphrenia 10.61 9.55 3 136746 9943 70781752
Type IV hypersensitivity reaction 10.60 9.55 22 136727 3513 70788182
Ill-defined disorder 10.57 9.55 62 136687 54679 70737016
Non-infectious endophthalmitis 10.56 9.55 7 136742 316 70791379
Myokymia 10.56 9.55 5 136744 116 70791579
Laryngeal obstruction 10.56 9.55 5 136744 116 70791579
Electrocardiogram T wave amplitude decreased 10.54 9.55 9 136740 597 70791098
Mastocytosis 10.45 9.55 8 136741 454 70791241
Nervous system disorder 10.42 9.55 81 136668 24065 70767630
Madarosis 10.42 9.55 18 136731 2505 70789190
Coccygectomy 10.41 9.55 3 136746 15 70791680
Gastroenteritis viral 10.41 9.55 74 136675 21381 70770314
Blood alkaline phosphatase increased 10.40 9.55 68 136681 58453 70733242
pH body fluid abnormal 10.37 9.55 5 136744 121 70791574
Incorrect product formulation administered 10.37 9.55 5 136744 121 70791574
Enthesopathy 10.33 9.55 4 136745 10865 70780830
Electrocardiogram U wave present 10.29 9.55 5 136744 123 70791572
Post-anoxic myoclonus 10.29 9.55 4 136745 56 70791639
Injection site oedema 10.28 9.55 12 136737 1162 70790533
Glycosylated haemoglobin increased 10.27 9.55 11 136738 17380 70774315
Larynx irritation 10.25 9.55 5 136744 124 70791571
Immunisation reaction 10.22 9.55 6 136743 218 70791477
Corneal opacity 10.21 9.55 11 136738 975 70790720
Hepatic cancer 10.19 9.55 3 136746 9680 70782015
Acute hepatic failure 10.18 9.55 24 136725 27648 70764047
Administration related reaction 10.18 9.55 5 136744 126 70791569
Nasal discharge discolouration 10.15 9.55 16 136733 2065 70789630
CSF pressure increased 10.12 9.55 6 136743 222 70791473
Injection site nerve damage 10.10 9.55 4 136745 59 70791636
Sedation 10.08 9.55 51 136698 46680 70745015
Sensorimotor disorder 10.07 9.55 10 136739 806 70790889
Lymphoma 10.03 9.55 9 136740 15453 70776242
Panniculitis 10.03 9.55 4 136745 10672 70781023
Corneal abrasion 10.03 9.55 11 136738 995 70790700
Arthritis 9.97 9.55 131 136618 97849 70693846
Product confusion 9.96 9.55 3 136746 18 70791677
Drug level decreased 9.94 9.55 6 136743 12618 70779077
Behaviour disorder 9.91 9.55 28 136721 5436 70786259
Cardiac procedure complication 9.87 9.55 7 136742 353 70791342
Lymphopenia 9.85 9.55 24 136725 27335 70764360
Vaginal abscess 9.79 9.55 7 136742 358 70791337
Vascular malformation 9.79 9.55 7 136742 358 70791337
Haematuria 9.78 9.55 77 136672 63496 70728199
Heart rate decreased 9.76 9.55 171 136578 61844 70729851
Lupus-like syndrome 9.75 9.55 5 136744 11510 70780185
Product formulation issue 9.73 9.55 10 136739 840 70790855
Hepatic function abnormal 9.71 9.55 84 136665 67912 70723783
Serotonin syndrome 9.71 9.55 124 136625 41990 70749705
Troponin increased 9.69 9.55 60 136689 16554 70775141
N-terminal prohormone brain natriuretic peptide 9.69 9.55 4 136745 66 70791629
Product distribution issue 9.69 9.55 11 136738 1034 70790661
No reaction on previous exposure to drug 9.57 9.55 6 136743 246 70791449
Diffuse large B-cell lymphoma 9.56 9.55 7 136742 13295 70778400

FDA Adverse Event Reporting System (Pediatric)

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
Methaemoglobinaemia 32.77 29.15 10 151 71 89560
Cardiac arrest neonatal 31.31 29.15 10 151 84 89547

Pharmacologic Action:

SourceCodeDescription
ATC A01AD01 ALIMENTARY TRACT AND METABOLISM
STOMATOLOGICAL PREPARATIONS
STOMATOLOGICAL PREPARATIONS
Other agents for local oral treatment
ATC B02BC09 BLOOD AND BLOOD FORMING ORGANS
ANTIHEMORRHAGICS
VITAMIN K AND OTHER HEMOSTATICS
Local hemostatics
ATC C01CA24 CARDIOVASCULAR SYSTEM
CARDIAC THERAPY
CARDIAC STIMULANTS EXCL. CARDIAC GLYCOSIDES
Adrenergic and dopaminergic agents
ATC R01AA14 RESPIRATORY SYSTEM
NASAL PREPARATIONS
DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE
Sympathomimetics, plain
ATC R03AA01 RESPIRATORY SYSTEM
DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
ADRENERGICS, INHALANTS
Alpha- and beta-adrenoreceptor agonists
ATC R03AK01 RESPIRATORY SYSTEM
DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
ADRENERGICS, INHALANTS
Adrenergics in combination with corticosteroids or other drugs, excl. anticholinergics
ATC S01EA01 SENSORY ORGANS
OPHTHALMOLOGICALS
ANTIGLAUCOMA PREPARATIONS AND MIOTICS
Sympathomimetics in glaucoma therapy
ATC S01EA51 SENSORY ORGANS
OPHTHALMOLOGICALS
ANTIGLAUCOMA PREPARATIONS AND MIOTICS
Sympathomimetics in glaucoma therapy
FDA CS M0003647 Catecholamines
FDA MoA N0000000209 Adrenergic alpha-Agonists
FDA MoA N0000000245 Adrenergic beta-Agonists
FDA EPC N0000175552 alpha-Adrenergic Agonist
FDA EPC N0000175555 beta-Adrenergic Agonist
FDA EPC N0000175570 Catecholamine
MeSH PA D018663 Adrenergic Agents
MeSH PA D000322 Adrenergic Agonists
MeSH PA D000316 Adrenergic alpha-Agonists
MeSH PA D000318 Adrenergic beta-Agonists
MeSH PA D018927 Anti-Asthmatic Agents
MeSH PA D001993 Bronchodilator Agents
MeSH PA D002317 Cardiovascular Agents
MeSH PA D009184 Mydriatics
MeSH PA D018377 Neurotransmitter Agents
MeSH PA D018373 Peripheral Nervous System Agents
MeSH PA D019141 Respiratory System Agents
MeSH PA D013566 Sympathomimetics
MeSH PA D014662 Vasoconstrictor Agents
CHEBI has role CHEBI:24621 hormones
CHEBI has role CHEBI:35522 beta-adrenergic agonists
CHEBI has role CHEBI:35523 bronchodilator
CHEBI has role CHEBI:35524 sympathomimetic
CHEBI has role CHEBI:35569 alpha-adrenergic agonists
CHEBI has role CHEBI:35620 vasodilator agents
CHEBI has role CHEBI:37886 adrenergic agonists
CHEBI has role CHEBI:50513 mydriatics
CHEBI has role CHEBI:75771 Mus musculus metabolites

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

DiseaseRelationSNOMED_IDDOID
Bronchiectasis indication 12295008 DOID:9563
Bronchitis indication 32398004 DOID:6132
Anaphylaxis indication 39579001
Local anesthesia, by infiltration indication 44596000
Low blood pressure indication 45007003
Wheezing indication 56018004
Hypotension associated with septic shock indication 76571007
Open-angle glaucoma indication 84494001 DOID:1067
Pulmonary emphysema indication 87433001
Dyspnea indication 267036007
Exacerbation of asthma indication 281239006
Asthma management indication 406162001
Acute exacerbation of asthma indication 708038006
Administration of Local Anesthetic Nerve Block indication
Allergic Reactions indication
Ventricular fibrillation off-label use 71908006
Asthma off-label use 195967001 DOID:2841
Local anesthesia off-label use 386761002
Cardiac arrest off-label use 410429000 DOID:0060319
Keratitis contraindication 5888003 DOID:4677
Bacterial septicemia contraindication 10001005 DOID:0040085
Sinus tachycardia contraindication 11092001
Myocardial infarction contraindication 22298006 DOID:5844
Aphakia contraindication 24010005
Complete atrioventricular block contraindication 27885002
Shock contraindication 27942005
Hypovolemia contraindication 28560003
Hypercapnia contraindication 29596007
Parkinsonism contraindication 32798002
Hyperthyroidism contraindication 34486009 DOID:7998
Hypertensive disorder contraindication 38341003 DOID:10763
Retinal detachment contraindication 42059000 DOID:5327
Hypokalemia contraindication 43339004
Conduction disorder of the heart contraindication 44808001
Stokes-Adams syndrome contraindication 46935006
Chronic heart failure contraindication 48447003
Bradycardia contraindication 48867003
Atrial fibrillation contraindication 49436004 DOID:0060224
Disorder of cardiovascular system contraindication 49601007 DOID:1287
Sinus bradycardia contraindication 49710005
Acute nephropathy contraindication 58574008
Hepatic failure contraindication 59927004
Iritis contraindication 65074000 DOID:1406
Cerebral arteriosclerosis contraindication 65312002
Diabetes mellitus contraindication 73211009 DOID:9351
Wolff-Parkinson-White pattern contraindication 74390002 DOID:384
Decreased respiratory function contraindication 80954004
Cardiogenic shock contraindication 89138009
Kidney disease contraindication 90708001 DOID:557
Myasthenia gravis contraindication 91637004 DOID:437
Open wound contraindication 125643001
Seizure disorder contraindication 128613002
Bleeding contraindication 131148009
Angina pectoris contraindication 194828000
Primary dilated cardiomyopathy contraindication 195021004
Partial atrioventricular block contraindication 195039008
Heart block contraindication 233916004
Disease of liver contraindication 235856003 DOID:409
Sepsis syndrome contraindication 238150007
Benign prostatic hyperplasia contraindication 266569009
Psychoneurotic personality disorder contraindication 268634009
Deficiency of cholinesterase contraindication 360607009
Hypoxia contraindication 389086002
Angle-closure glaucoma contraindication 392291006 DOID:13550
Peripheral vascular disease contraindication 400047006
Anterior uveitis contraindication 410692006 DOID:1407
Chronic myocardial ischemia contraindication 413844008 DOID:3393
Disorder of coronary artery contraindication 414024009
Denuded skin contraindication 418242004
Thrombosis contraindication 439127006
Pupillary Block Glaucoma contraindication
Lidocaine Toxicity contraindication
Reduced Hepatic Blood Flow contraindication
Regional Anesthesia for Labor Pain contraindication
Occlusive Vascular Disease 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 9.97 acidic
pKa2 12.82 acidic
pKa3 13.64 acidic
pKa4 8.71 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
EQ 0.1MG/DELIVERY AUVI-Q KALEO INC N201739 Nov. 17, 2017 RX SOLUTION INTRAMUSCULAR, SUBCUTANEOUS 9833573 Nov. 23, 2024 METHOD TO TREAT SEVERE ALLERGIC EMERGENCIES IN PATIENTS WEIGHING 7.5 TO 15 KG (16.5 TO 33 LBS)
EQ 0.15MG/DELIVERY AUVI-Q KALEO INC N201739 Aug. 10, 2012 RX SOLUTION INTRAMUSCULAR, SUBCUTANEOUS 9149579 July 19, 2025 METHOD OF TREATING ALLERGIC REACTION VIA INJECTION
EQ 0.1MG/DELIVERY AUVI-Q KALEO INC N201739 Nov. 17, 2017 RX SOLUTION INTRAMUSCULAR, SUBCUTANEOUS 9149579 July 19, 2025 METHOD OF TREATING ALLERGIC REACTION VIA INJECTION
EQ 0.3MG/DELIVERY AUVI-Q KALEO INC N201739 Aug. 10, 2012 RX SOLUTION INTRAMUSCULAR, SUBCUTANEOUS 9149579 July 19, 2025 METHOD OF TREATING ALLERGIC REACTION VIA INJECTION
EQ 0.15MG/DELIVERY AUVI-Q KALEO INC N201739 Aug. 10, 2012 RX SOLUTION INTRAMUSCULAR, SUBCUTANEOUS 9724471 May 23, 2027 METHOD FOR CONFIRMING DOSE DELIVERY
EQ 0.1MG/DELIVERY AUVI-Q KALEO INC N201739 Nov. 17, 2017 RX SOLUTION INTRAMUSCULAR, SUBCUTANEOUS 9724471 May 23, 2027 METHOD FOR CONFIRMING DOSE DELIVERY
EQ 0.3MG/DELIVERY AUVI-Q KALEO INC N201739 Aug. 10, 2012 RX SOLUTION INTRAMUSCULAR, SUBCUTANEOUS 9724471 May 23, 2027 METHOD FOR CONFIRMING DOSE DELIVERY
1MG/ML (1MG/ML) EPINEPHRINE BPI LABS N205029 July 29, 2014 RX SOLUTION INTRAVENOUS, INTRAOCULAR, INTRAMUSCULAR, SUBCUTANEOUS 10004700 Aug. 14, 2034 EMERGENCY TREATMENT OF ALLERGIC REACTIONS (TYPE 1), INCLUDING ANAPHYLAXIS; A METHOD OF TREATING ALLERGIC REACTION, ANAPHYLAXIS, ANAPHYLACTIC SHOCK, OR COMBINATION THEREOF BY AN INJECTION OF AT LEAST ONE DOSAGE OF THE INJECTABLE LIQUID PHARMACEUTICAL
1MG/ML (1MG/ML) EPINEPHRINE BPI LABS N205029 July 29, 2014 RX SOLUTION INTRAVENOUS, INTRAOCULAR, INTRAMUSCULAR, SUBCUTANEOUS 10039728 Aug. 14, 2034 INCREASING MEAN ARTERIAL BLOOD PRESSURE IN ADULT PATIENTS WITH HYPOTENSION ASSOCIATED WITH SEPTIC SHOCK
1MG/ML (1MG/ML) EPINEPHRINE BPI LABS N205029 July 29, 2014 RX SOLUTION INTRAVENOUS, INTRAOCULAR, INTRAMUSCULAR, SUBCUTANEOUS 9283197 Aug. 15, 2034 EMERGENCY TREATMENT OF ALLERGIC REACTIONS (TYPE I), INCLUDING ANAPHYLAXIS
1MG/ML (1MG/ML) EPINEPHRINE BPI LABS N205029 July 29, 2014 RX SOLUTION INTRAVENOUS, INTRAOCULAR, INTRAMUSCULAR, SUBCUTANEOUS 9283197 Aug. 15, 2034 INCREASING MEAN ARTERIAL BLOOD PRESSURE IN ADULT PATIENTS WITH HYPOTENSION ASSOCIATED WITH SEPTIC SHOCK
1MG/ML (1MG/ML) EPINEPHRINE BPI LABS N205029 July 29, 2014 RX SOLUTION INTRAVENOUS, INTRAOCULAR, INTRAMUSCULAR, SUBCUTANEOUS 9283197 Aug. 15, 2034 INDUCTION AND MAINTENANCE OF MYDRIASIS DURING INTRAOCULAR SURGERY
EQ 1MG BASE/ML (EQ 1MG BASE/ML) ADRENALIN PAR STERILE PRODUCTS N204200 Dec. 7, 2012 RX SOLUTION INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS 9295657 March 13, 2035 EMERGENCY TREATMENT OF ALLERGIC REACTIONS (TYPE I), INCLUDING ANAPHYLAXIS
EQ 30MG BASE/30ML (EQ 1MG BASE/ML) ADRENALIN PAR STERILE PRODUCTS N204640 Dec. 18, 2013 RX SOLUTION INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS 9295657 March 13, 2035 EMERGENCY TREATMENT OF ALLERGIC REACTIONS (TYPE I), INCLUDING ANAPHYLAXIS
0.15MG/0.3ML (0.15MG/0.3ML) SYMJEPI ADAMIS PHARMS CORP N207534 Sept. 27, 2018 RX SOLUTION INTRAMUSCULAR, SUBCUTANEOUS 11141540 Oct. 20, 2036 A METHOD FOR ADMINISTERING A THERAPEUTIC DOSE OF EPINEPHRINE
0.3MG/0.3ML (0.3MG/0.3ML) SYMJEPI ADAMIS PHARMS CORP N207534 June 15, 2017 RX SOLUTION INTRAMUSCULAR, SUBCUTANEOUS 11141540 Oct. 20, 2036 A METHOD FOR ADMINISTERING A THERAPEUTIC DOSE OF EPINEPHRINE
EQ 0.15MG/DELIVERY AUVI-Q KALEO INC N201739 Aug. 10, 2012 RX SOLUTION INTRAMUSCULAR, SUBCUTANEOUS 10688244 Dec. 21, 2037 METHOD OF TREATING AN ALLERGIC REACTION USING AN AUTO-INJECTOR
EQ 0.15MG/DELIVERY AUVI-Q KALEO INC N201739 Aug. 10, 2012 RX SOLUTION INTRAMUSCULAR, SUBCUTANEOUS 10842938 Dec. 21, 2037 METHOD OF TREATING AN ALLERGIC REACTION USING AN AUTO-INJECTOR
EQ 0.1MG/DELIVERY AUVI-Q KALEO INC N201739 Nov. 17, 2017 RX SOLUTION INTRAMUSCULAR, SUBCUTANEOUS 10688244 Dec. 21, 2037 METHOD OF TREATING AN ALLERGIC REACTION USING AN AUTO-INJECTOR
EQ 0.1MG/DELIVERY AUVI-Q KALEO INC N201739 Nov. 17, 2017 RX SOLUTION INTRAMUSCULAR, SUBCUTANEOUS 10842938 Dec. 21, 2037 METHOD OF TREATING AN ALLERGIC REACTION USING AN AUTO-INJECTOR

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Alpha-1D adrenergic receptor GPCR AGONIST Ki 6.66 CHEMBL CHEMBL
Alpha-1B adrenergic receptor GPCR AGONIST Ki 6.50 IUPHAR CHEMBL
Alpha-2A adrenergic receptor GPCR AGONIST Ki 6.56 DRUG MATRIX CHEMBL
Beta-2 adrenergic receptor GPCR AGONIST Kd 6.20 CHEMBL CHEMBL
Alpha-1A adrenergic receptor GPCR AGONIST Ki 5.70 CHEMBL CHEMBL
Alpha-2B adrenergic receptor GPCR AGONIST Ki 6.40 DRUG MATRIX CHEMBL
Alpha-2C adrenergic receptor GPCR AGONIST Ki 6.45 DRUG MATRIX CHEMBL
Beta-1 adrenergic receptor GPCR Ki 5.40 PDSP
D(1A) dopamine receptor GPCR Kd 4.26 CHEMBL
D(2) dopamine receptor GPCR Ki 6.04 CHEMBL
Sodium-dependent noradrenaline transporter Transporter Ki 5.43 PDSP
Alpha-1D adrenergic receptor GPCR AGONIST Ki 6.30 IUPHAR
Mu-type opioid receptor GPCR Ki 5.40 CHEMBL
Beta-1 adrenergic receptor GPCR Ki 5.96 CHEMBL
Beta-2 adrenergic receptor GPCR Ki 6.18 CHEMBL
Beta-2 adrenergic receptor GPCR Ki 6.14 CHEMBL
Beta-1 adrenergic receptor GPCR Ki 5.52 CHEMBL
Adrenergic receptor alpha-2 GPCR Ki 7.89 CHEMBL
Adrenergic receptor beta GPCR IC50 4.54 CHEMBL
M18 aspartyl aminopeptidase Enzyme IC50 5.52 CHEMBL
Arachidonate 15-lipoxygenase Enzyme IC50 5.48 DRUG MATRIX
Alpha-1B adrenergic receptor GPCR Ki 6.01 DRUG MATRIX
Alpha-1A adrenergic receptor GPCR IC50 6.20 CHEMBL

External reference:

IDSource
4018034 VUID
N0000146377 NUI
D00996 KEGG_DRUG
51-42-3 SECONDARY_CAS_RN
4018032 VANDF
4018033 VANDF
4018034 VANDF
C0014563 UMLSCUI
CHEBI:28918 CHEBI
ALE PDB_CHEM_ID
CHEMBL679 ChEMBL_ID
DB00668 DRUGBANK_ID
CHEMBL1256958 ChEMBL_ID
D004837 MESH_DESCRIPTOR_UI
5816 PUBCHEM_CID
2142 INN_ID
479 IUPHAR_LIGAND_ID
YKH834O4BH UNII
203180 RXNORM
3451 MMSL
3500 MMSL
4663 MMSL
4664 MMSL
4665 MMSL
4667 MMSL
72412 MMSL
d00699 MMSL
001774 NDDF
001776 NDDF
006223 NDDF
126134000 SNOMEDCT_US
387362001 SNOMEDCT_US
50685004 SNOMEDCT_US
65502005 SNOMEDCT_US
CHEMBL3183376 ChEMBL_ID
55-31-2 SECONDARY_CAS_RN

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Epinephrine HUMAN PRESCRIPTION DRUG LABEL 1 0093-5985 INJECTION 0.15 mg INTRAMUSCULAR ANDA 24 sections
Epinephrine HUMAN PRESCRIPTION DRUG LABEL 1 0093-5986 INJECTION 0.30 mg INTRAMUSCULAR ANDA 24 sections
epinephrine HUMAN PRESCRIPTION DRUG LABEL 1 0115-1694 INJECTION 0.30 mg SUBCUTANEOUS NDA AUTHORIZED GENERIC 25 sections
epinephrine HUMAN PRESCRIPTION DRUG LABEL 1 0115-1695 INJECTION 0.15 mg SUBCUTANEOUS NDA AUTHORIZED GENERIC 25 sections
LIDOCAINE HCl and EPINEPHRINE HUMAN PRESCRIPTION DRUG LABEL 2 0264-9378 INJECTION 0.01 mg EPIDURAL ANDA 12 sections
Lidocaine HUMAN PRESCRIPTION DRUG LABEL 2 0362-0262 INJECTION, SOLUTION 0.02 mg SUBCUTANEOUS ANDA 23 sections
Lidocaine HUMAN PRESCRIPTION DRUG LABEL 2 0362-0262 INJECTION, SOLUTION 0.02 mg SUBCUTANEOUS ANDA 23 sections
Marcaine HUMAN PRESCRIPTION DRUG LABEL 2 0362-0557 INJECTION, SOLUTION 0.01 mg SUBCUTANEOUS ANDA 19 sections
Zorcaine HUMAN PRESCRIPTION DRUG LABEL 2 0362-0830 INJECTION, SOLUTION 0.01 mg SUBCUTANEOUS NDA 29 sections
Lidocaine HUMAN PRESCRIPTION DRUG LABEL 2 0362-0898 INJECTION, SOLUTION 0.01 mg SUBCUTANEOUS ANDA 23 sections
Lidocaine HUMAN PRESCRIPTION DRUG LABEL 2 0362-0898 INJECTION, SOLUTION 0.01 mg SUBCUTANEOUS ANDA 23 sections
Lignospan Standard HUMAN PRESCRIPTION DRUG LABEL 2 0362-1095 INJECTION, SOLUTION 0.01 mg SUBCUTANEOUS ANDA 23 sections
Lignospan Standard HUMAN PRESCRIPTION DRUG LABEL 2 0362-1095 INJECTION, SOLUTION 0.01 mg SUBCUTANEOUS ANDA 23 sections
Lignospan Forte HUMAN PRESCRIPTION DRUG LABEL 2 0362-1096 INJECTION, SOLUTION 0.02 mg SUBCUTANEOUS ANDA 23 sections
Lignospan Forte HUMAN PRESCRIPTION DRUG LABEL 2 0362-1096 INJECTION, SOLUTION 0.02 mg SUBCUTANEOUS ANDA 23 sections
Octocaine 50 HUMAN PRESCRIPTION DRUG LABEL 2 0362-9010 INJECTION, SOLUTION 0.02 mg SUBCUTANEOUS ANDA 24 sections
Vivacaine HUMAN PRESCRIPTION DRUG LABEL 2 0362-9011 INJECTION, SOLUTION 0.01 mg SUBCUTANEOUS ANDA 19 sections
Vivacaine HUMAN PRESCRIPTION DRUG LABEL 2 0362-9011 INJECTION, SOLUTION 0.01 mg SUBCUTANEOUS ANDA 19 sections
Vivacaine HUMAN PRESCRIPTION DRUG LABEL 2 0362-9011 INJECTION, SOLUTION 0.01 mg SUBCUTANEOUS ANDA 19 sections
Prilocaine Hydrochloride with Epinephrine HUMAN PRESCRIPTION DRUG LABEL 2 0362-9013 INJECTION, SOLUTION 0.01 mg SUBCUTANEOUS ANDA 24 sections
Octocaine 100 HUMAN PRESCRIPTION DRUG LABEL 2 0362-9023 INJECTION, SOLUTION 0.01 mg SUBCUTANEOUS ANDA 24 sections
Septocaine and Epinephrine HUMAN PRESCRIPTION DRUG LABEL 2 0362-9048 INJECTION, SOLUTION 0.01 mg SUBCUTANEOUS NDA 29 sections
Septocaine and Epinephrine HUMAN PRESCRIPTION DRUG LABEL 2 0362-9049 INJECTION, SOLUTION 0.01 mg SUBCUTANEOUS NDA 29 sections
LIDOCAINE HUMAN PRESCRIPTION DRUG LABEL 2 0404-6500 INJECTION, SOLUTION 0.02 mg SUBCUTANEOUS ANDA 24 sections
LIDOCAINE HUMAN PRESCRIPTION DRUG LABEL 2 0404-6500 INJECTION, SOLUTION 0.02 mg SUBCUTANEOUS ANDA 24 sections
Lidocaine HUMAN PRESCRIPTION DRUG LABEL 2 0404-6512 INJECTION, SOLUTION 0.01 mg SUBCUTANEOUS ANDA 24 sections
Lidocaine HUMAN PRESCRIPTION DRUG LABEL 2 0404-6512 INJECTION, SOLUTION 0.01 mg SUBCUTANEOUS ANDA 24 sections
Articaine Hydrochloride and Epinephrine HUMAN PRESCRIPTION DRUG LABEL 2 0404-6620 INJECTION, SOLUTION 0.01 mg SUBCUTANEOUS NDA 29 sections
Articaine Hydrochloride and Epinephrine HUMAN PRESCRIPTION DRUG LABEL 2 0404-6625 INJECTION, SOLUTION 0.01 mg SUBCUTANEOUS NDA 29 sections
Adrenalin HUMAN PRESCRIPTION DRUG LABEL 1 0404-9810 INJECTION 1 mg INTRAMUSCULAR NDA 15 sections