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 721.57 9.86 1271 102648 169287 50331918
Hereditary angioedema 563.40 9.86 258 103661 5184 50496021
Stress cardiomyopathy 418.06 9.86 238 103681 7649 50493556
Device failure 368.18 9.86 194 103725 5334 50495871
Anaphylactic reaction 350.76 9.86 491 103428 53564 50447641
Local anaesthetic systemic toxicity 343.35 9.86 101 103818 511 50500694
Toxic anterior segment syndrome 321.31 9.86 121 103798 1444 50499761
Anaesthetic complication 309.52 9.86 121 103798 1609 50499596
Infusion site swelling 263.04 9.86 171 103748 7005 50494200
Infusion site pain 240.66 9.86 201 103718 12145 50489060
Contraindicated product administered 240.16 9.86 17 103902 148941 50352264
Infusion site erythema 235.02 9.86 172 103747 8555 50492650
Accidental exposure to product 232.09 9.86 261 103658 22796 50478409
Cardiac arrest 221.69 9.86 514 103405 83137 50418068
Drug intolerance 218.97 9.86 88 103831 219016 50282189
Pemphigus 218.74 9.86 6 103913 120160 50381045
Joint swelling 194.26 9.86 133 103786 245153 50256052
Anaphylactic shock 187.41 9.86 219 103700 19936 50481269
Bronchitis 181.99 9.86 548 103371 103611 50397594
Hand deformity 178.74 9.86 6 103913 100193 50401012
Infusion site extravasation 177.76 9.86 133 103786 6843 50494362
Systemic lupus erythematosus 176.05 9.86 37 103882 140585 50360620
Upper respiratory tract infection 172.45 9.86 403 103516 65495 50435710
Glossodynia 170.58 9.86 19 103900 115550 50385655
Pulseless electrical activity 155.81 9.86 122 103797 6719 50494486
Infusion site pruritus 154.63 9.86 98 103821 3839 50497366
Synovitis 154.20 9.86 33 103886 123832 50377373
Chondrolysis 146.57 9.86 41 103878 167 50501038
Alopecia 144.95 9.86 174 103745 244873 50256332
Completed suicide 143.53 9.86 46 103873 131843 50369362
Lagophthalmos 132.56 9.86 41 103878 253 50500952
Hepatic enzyme increased 129.47 9.86 60 103859 137320 50363885
Rheumatoid arthritis 129.41 9.86 135 103784 202415 50298790
Bradycardia 124.99 9.86 352 103567 64074 50437131
Arthropathy 117.89 9.86 91 103828 157815 50343390
Ear infection 117.80 9.86 200 103719 25770 50475435
Kounis syndrome 113.17 9.86 53 103866 1122 50500083
Abdominal discomfort 112.63 9.86 189 103730 231452 50269753
Incorrect route of product administration 111.35 9.86 163 103756 18503 50482702
Administration site swelling 109.49 9.86 50 103869 997 50500208
Urticaria 109.37 9.86 541 103378 129020 50372185
Pericarditis 108.69 9.86 16 103903 78673 50422532
Headache 108.07 9.86 1546 102373 504989 49996216
Wound 108.03 9.86 41 103878 105753 50395452
Infusion site bruising 107.68 9.86 64 103855 2231 50498974
Ventricular tachycardia 107.45 9.86 147 103772 15674 50485531
Hypotension 103.11 9.86 831 103088 234638 50266567
Corneal oedema 101.90 9.86 52 103867 1335 50499870
Therapeutic product effect decreased 100.79 9.86 79 103840 135971 50365234
Product quality issue 97.97 9.86 204 103715 30654 50470551
Infusion site nodule 96.84 9.86 47 103872 1080 50500125
General physical health deterioration 95.44 9.86 91 103828 142343 50358862
Infusion site haemorrhage 89.57 9.86 63 103856 2941 50498264
Fear 86.71 9.86 127 103792 14422 50486783
Arthralgia 86.70 9.86 537 103382 438165 50063040
Treatment failure 79.95 9.86 99 103820 137538 50363667
Respiratory tract infection 79.59 9.86 192 103727 31825 50469380
Anhedonia 79.52 9.86 98 103821 9426 50491779
Helicobacter infection 79.11 9.86 6 103913 49696 50451509
Renal injury 79.09 9.86 93 103826 8518 50492687
COVID-19 78.13 9.86 242 103677 46420 50454785
Bronchospasm 77.66 9.86 122 103797 14732 50486473
Left ventricle outflow tract obstruction 77.18 9.86 26 103893 218 50500987
Administration site pain 76.53 9.86 34 103885 634 50500571
Injection site ischaemia 75.13 9.86 15 103904 3 50501202
Ventricular fibrillation 73.05 9.86 99 103820 10460 50490745
Shock 72.07 9.86 142 103777 20508 50480697
Cardiogenic shock 71.88 9.86 121 103798 15478 50485727
Incorrect drug administration rate 71.60 9.86 52 103867 2554 50498651
Asthma 71.09 9.86 367 103552 88970 50412235
Stridor 71.05 9.86 56 103863 3113 50498092
Unevaluable event 70.82 9.86 232 103687 45834 50455371
Methaemoglobinaemia 70.79 9.86 47 103872 1995 50499210
Maternal exposure during delivery 68.96 9.86 36 103883 970 50500235
Infusion site mass 68.67 9.86 38 103881 1154 50500051
Expired product administered 66.62 9.86 68 103851 5314 50495891
Injection site pallor 66.61 9.86 17 103902 44 50501161
Electrocardiogram ST segment elevation 66.55 9.86 56 103863 3417 50497788
Cauda equina syndrome 66.47 9.86 32 103887 722 50500483
Endophthalmitis 66.40 9.86 52 103867 2864 50498341
Injury associated with device 65.45 9.86 53 103866 3064 50498141
Tachycardia 64.19 9.86 387 103532 99376 50401829
Administration site erythema 63.77 9.86 28 103891 507 50500698
Pulse absent 61.82 9.86 62 103857 4744 50496461
Arteriospasm coronary 61.39 9.86 53 103866 3349 50497856
Airway peak pressure increased 57.64 9.86 22 103897 273 50500932
Peripheral ischaemia 56.55 9.86 56 103863 4220 50496985
Folliculitis 56.48 9.86 7 103912 39218 50461987
Muscle injury 54.98 9.86 6 103913 37105 50464100
Infusion site urticaria 54.95 9.86 31 103888 978 50500227
Hypopyon 54.79 9.86 27 103892 642 50500563
Diarrhoea 54.13 9.86 867 103052 587609 49913596
Hyponatraemia 53.89 9.86 71 103848 96068 50405137
Migraine 53.59 9.86 300 103619 74980 50426225
Injury 52.19 9.86 219 103700 48706 50452499
Impaired healing 51.05 9.86 41 103878 69745 50431460
Neutropenia 50.96 9.86 146 103773 147819 50353386
Confusional state 50.73 9.86 203 103716 185725 50315480
Cataract operation complication 50.63 9.86 16 103903 107 50501098
Generalised tonic-clonic seizure 50.25 9.86 143 103776 26167 50475038
Emotional distress 50.16 9.86 151 103768 28512 50472693
Extradural abscess 50.10 9.86 27 103892 777 50500428
Electrocardiogram ST segment depression 49.69 9.86 42 103877 2578 50498627
Body tinea 49.55 9.86 32 103887 1295 50499910
Infusion site rash 49.22 9.86 32 103887 1310 50499895
Haemodynamic instability 49.20 9.86 71 103848 7953 50493252
Tryptase increased 48.31 9.86 18 103901 208 50500997
Acute kidney injury 48.17 9.86 273 103646 227785 50273420
Lip swelling 47.79 9.86 135 103784 24601 50476604
Impaired quality of life 46.87 9.86 60 103859 5996 50495209
Staphylococcal infection 45.73 9.86 169 103750 35447 50465758
Discomfort 44.25 9.86 98 103821 108282 50392923
Pharyngeal oedema 44.10 9.86 89 103830 13076 50488129
Needle issue 44.06 9.86 64 103855 7211 50493994
Illness 43.62 9.86 130 103789 24410 50476795
Ventricular hypokinesia 43.40 9.86 47 103872 3933 50497272
Infusion site reaction 43.16 9.86 36 103883 2170 50499035
Musculoskeletal stiffness 42.62 9.86 129 103790 128352 50372853
Liquid product physical issue 42.49 9.86 24 103895 759 50500446
Pulmonary oedema 42.41 9.86 206 103713 48732 50452473
Infusion site irritation 41.80 9.86 22 103897 603 50500602
Lower respiratory tract infection 41.45 9.86 83 103836 95118 50406087
Anaemia 40.91 9.86 327 103592 252129 50249076
COVID-19 immunisation 40.84 9.86 23 103896 723 50500482
Decreased appetite 40.04 9.86 245 103674 200678 50300527
Extradural haematoma 39.86 9.86 30 103889 1557 50499648
Wrong product administered 39.76 9.86 52 103867 5308 50495897
Abortion spontaneous 39.70 9.86 18 103901 41754 50459451
Angioedema 39.67 9.86 168 103751 37508 50463697
Post procedural complication 39.06 9.86 92 103827 15012 50486193
Seizure 37.71 9.86 389 103530 117485 50383720
C-reactive protein increased 37.34 9.86 49 103870 66425 50434780
Procedural hypotension 37.32 9.86 25 103894 1077 50500128
Vitritis 37.27 9.86 23 103896 859 50500346
Product use issue 37.19 9.86 169 103750 149306 50351899
Blood creatinine increased 37.07 9.86 62 103857 76098 50425107
Troponin I increased 36.79 9.86 31 103888 1895 50499310
Intentional self-injury 36.19 9.86 3 103916 23109 50478096
Status asthmaticus 35.91 9.86 22 103897 811 50500394
Type 2 diabetes mellitus 35.61 9.86 13 103906 34362 50466843
C-reactive protein abnormal 35.43 9.86 7 103912 27802 50473403
Swollen tongue 35.21 9.86 134 103785 28496 50472709
Unresponsive to stimuli 35.00 9.86 140 103779 30469 50470736
Administration site reaction 34.77 9.86 14 103905 202 50501003
Administration site bruise 34.55 9.86 15 103904 264 50500941
Mobility decreased 34.55 9.86 70 103849 79878 50421327
Administration site pruritus 34.50 9.86 15 103904 265 50500940
Infection susceptibility increased 34.46 9.86 34 103885 2550 50498655
Pancytopenia 33.47 9.86 77 103842 83953 50417252
Stomatitis 33.43 9.86 102 103817 101242 50399963
Platelet aggregation inhibition 33.41 9.86 12 103907 124 50501081
Anaesthetic complication neurological 33.38 9.86 13 103906 171 50501034
Anaphylactoid reaction 33.31 9.86 38 103881 3368 50497837
Injection site hypoaesthesia 33.03 9.86 16 103903 366 50500839
Procedural complication 33.03 9.86 45 103874 4778 50496427
Laryngeal oedema 32.88 9.86 46 103873 5007 50496198
Blood pressure decreased 32.88 9.86 212 103707 55697 50445508
Inhibitory drug interaction 32.83 9.86 31 103888 2202 50499003
Circulatory collapse 32.79 9.86 103 103816 19897 50481308
Swelling 32.61 9.86 260 103659 200612 50300593
Uterine hypertonus 32.53 9.86 14 103905 241 50500964
Nerve root injury 32.50 9.86 9 103910 35 50501170
Injection site injury 32.48 9.86 18 103901 548 50500657
Asthenia 31.96 9.86 462 103457 318580 50182625
Anterior chamber cell 31.94 9.86 17 103902 477 50500728
Blister 31.87 9.86 81 103838 85337 50415868
Hypoaesthesia oral 31.82 9.86 69 103850 10659 50490546
Product contamination microbial 31.71 9.86 13 103906 197 50501008
Kidney infection 31.16 9.86 97 103822 18649 50482556
Injection site coldness 31.01 9.86 10 103909 72 50501133
Administration site extravasation 30.97 9.86 19 103900 702 50500503
Chills 30.87 9.86 319 103600 96368 50404837
Ophthalmoplegia 30.73 9.86 24 103895 1316 50499889
Disease progression 30.55 9.86 98 103821 95768 50405437
Anxiety 30.36 9.86 523 103396 177083 50324122
Mydriasis 29.99 9.86 67 103852 10560 50490645
Wheezing 29.84 9.86 224 103695 61823 50439382
Sinus tachycardia 29.68 9.86 104 103815 21250 50479955
Eye infection 29.63 9.86 62 103857 9344 50491861
Infusion site warmth 29.30 9.86 24 103895 1410 50499795
Leukopenia 29.28 9.86 59 103860 67469 50433736
Type I hypersensitivity 29.27 9.86 30 103889 2355 50498850
Psoriatic arthropathy 29.25 9.86 32 103887 47000 50454205
Peripheral swelling 29.22 9.86 276 103643 205660 50295545
Gas gangrene 29.16 9.86 10 103909 89 50501116
Malignant neoplasm progression 29.13 9.86 60 103859 68064 50433141
Condition aggravated 29.10 9.86 432 103487 296626 50204579
Thrombocytopenia 29.04 9.86 149 103770 127524 50373681
Drug reaction with eosinophilia and systemic symptoms 29.02 9.86 11 103908 28413 50472792
Chest discomfort 28.70 9.86 304 103615 92418 50408787
Neuromuscular block prolonged 28.64 9.86 16 103903 495 50500710
Cyanosis 28.48 9.86 82 103837 15102 50486103
Hyperaesthesia 28.27 9.86 56 103863 8117 50493088
Bursitis infective 28.08 9.86 22 103897 1212 50499993
Fungal infection 28.05 9.86 129 103790 29836 50471369
Vasospasm 27.96 9.86 17 103902 618 50500587
Vasoplegia syndrome 27.85 9.86 21 103898 1093 50500112
Infusion site discomfort 27.55 9.86 19 103900 859 50500346
Aqueous fibrin 27.53 9.86 9 103910 68 50501137
Urinary tract infection 27.32 9.86 627 103292 223393 50277812
Blood cholesterol increased 26.82 9.86 45 103874 55170 50446035
Blood pH decreased 26.78 9.86 29 103890 2426 50498779
Liver function test abnormal 26.67 9.86 31 103888 44308 50456897
Anaphylactoid shock 26.54 9.86 13 103906 305 50500900
Peripheral nerve injury 26.46 9.86 14 103905 388 50500817
Bladder prolapse 26.24 9.86 25 103894 1796 50499409
Myopathy toxic 26.23 9.86 14 103905 395 50500810
Eyelid rash 26.16 9.86 9 103910 81 50501124
Meningitis chemical 26.13 9.86 10 103909 125 50501080
Ventricular extrasystoles 26.06 9.86 63 103856 10453 50490752
Death 26.05 9.86 491 103428 324888 50176317
Throat tightness 25.99 9.86 98 103821 20749 50480456
PO2 decreased 25.91 9.86 22 103897 1359 50499846
Corneal epithelium defect 25.90 9.86 13 103906 322 50500883
Systemic toxicity 25.75 9.86 7 103912 25 50501180
Fear of eating 25.71 9.86 13 103906 327 50500878
Cardiac failure congestive 25.69 9.86 88 103831 84294 50416911
Pneumocephalus 25.37 9.86 10 103909 136 50501069
Removal of foreign body 25.28 9.86 6 103913 10 50501195
Paraesthesia oral 24.89 9.86 68 103851 12153 50489052
Paralysis 24.87 9.86 55 103864 8609 50492596
Hip arthroplasty 24.70 9.86 16 103903 30413 50470792
Pharyngeal swelling 24.56 9.86 38 103881 4528 50496677
Cystitis 24.39 9.86 166 103753 44398 50456807
Upper airway obstruction 24.36 9.86 15 103904 558 50500647
Pharyngitis streptococcal 24.26 9.86 55 103864 8753 50492452
Cholestasis 24.05 9.86 11 103908 25390 50475815
Myocardial ischaemia 24.03 9.86 65 103854 11548 50489657
Troponin T increased 23.95 9.86 18 103901 932 50500273
Parophthalmia 23.73 9.86 12 103907 302 50500903
Retinal vasculitis 23.66 9.86 17 103902 821 50500384
Seasonal allergy 23.53 9.86 75 103844 14601 50486604
Septic arthritis staphylococcal 23.45 9.86 13 103906 396 50500809
Multiple organ dysfunction syndrome 23.24 9.86 180 103739 50157 50451048
Sensory loss 23.21 9.86 50 103869 7688 50493517
Bundle branch block left 23.15 9.86 44 103875 6186 50495019
Respiratory acidosis 22.93 9.86 43 103876 5985 50495220
Inappropriate schedule of product administration 22.93 9.86 237 103682 71594 50429611
Loss of personal independence in daily activities 22.74 9.86 71 103848 69979 50431226
Knee arthroplasty 22.73 9.86 24 103895 35822 50465383
Glucose tolerance impaired 22.65 9.86 39 103880 5079 50496126
Cranial nerve palsies multiple 22.16 9.86 6 103913 21 50501184
Trigemino-cardiac reflex 22.00 9.86 7 103912 48 50501157
Abdominal pain upper 21.96 9.86 215 103704 159094 50342111
Drug ineffective for unapproved indication 21.71 9.86 94 103825 21187 50480018
Paraplegia 21.70 9.86 26 103893 2428 50498777
Dermatitis contact 21.64 9.86 52 103867 8594 50492611
Nerve block 21.57 9.86 13 103906 465 50500740
Gastroenteritis viral 21.53 9.86 86 103833 18700 50482505
Osteonecrosis of jaw 21.51 9.86 21 103898 32505 50468700
Influenza like illness 21.49 9.86 196 103723 57263 50443942
Rectal prolapse 21.47 9.86 22 103897 1727 50499478
PCO2 increased 21.02 9.86 18 103901 1125 50500080
Arterial spasm 20.85 9.86 7 103912 58 50501147
Spinal epidural haemorrhage 20.76 9.86 8 103911 102 50501103
Red blood cell sedimentation rate increased 20.62 9.86 18 103901 29398 50471807
Fear of death 20.38 9.86 16 103903 884 50500321
Stress 20.37 9.86 184 103735 53609 50447596
Blood lactic acid increased 20.21 9.86 39 103880 5546 50495659
Electrocardiogram T wave inversion 20.20 9.86 29 103890 3232 50497973
Postresuscitation encephalopathy 20.16 9.86 5 103914 11 50501194
Drug resistance 19.98 9.86 7 103912 18982 50482223
Hepatotoxicity 19.90 9.86 16 103903 27210 50473995
Drug abuse 19.90 9.86 60 103859 59786 50441419
Skin infection 19.87 9.86 63 103856 12228 50488977
Axillary nerve injury 19.86 9.86 5 103914 12 50501193
Harlequin syndrome 19.68 9.86 6 103913 35 50501170
Orthostatic hypotension 19.53 9.86 19 103900 29462 50471743
Administration site nodule 19.40 9.86 6 103913 37 50501168
Ischaemia 19.36 9.86 33 103886 4264 50496941
Local reaction 19.35 9.86 13 103906 563 50500642
Lung hyperinflation 19.33 9.86 17 103902 1101 50500104
Administration site discolouration 19.27 9.86 6 103913 38 50501167
Administration site irritation 19.27 9.86 6 103913 38 50501167
Vitamin D increased 19.26 9.86 13 103906 567 50500638
Injection site inflammation 19.13 9.86 28 103891 3177 50498028
Spinal anaesthesia 18.88 9.86 6 103913 41 50501164
Liver injury 18.86 9.86 14 103905 24792 50476413
Administration site haemorrhage 18.78 9.86 7 103912 81 50501124
Jaundice 18.74 9.86 16 103903 26413 50474792
Atonic urinary bladder 18.63 9.86 7 103912 83 50501122
Device expulsion 18.61 9.86 19 103900 28803 50472402
Vasoconstriction 18.60 9.86 12 103907 485 50500720
Oral herpes 18.50 9.86 88 103831 20637 50480568
Loss of consciousness 18.43 9.86 309 103610 104044 50397161
Sinus disorder 18.42 9.86 81 103838 18377 50482828
Psoriasis 18.37 9.86 76 103843 68924 50432281
Neurogenic shock 18.36 9.86 10 103909 294 50500911
Mean arterial pressure decreased 18.26 9.86 8 103911 144 50501061
Irritable bowel syndrome 18.25 9.86 50 103869 51391 50449814
Product dose omission issue 18.09 9.86 500 103419 183338 50317867
Conjunctival oedema 18.05 9.86 13 103906 630 50500575
Hepatocellular injury 18.04 9.86 16 103903 25931 50475274
Reversible cerebral vasoconstriction syndrome 18.01 9.86 22 103897 2097 50499108
Agranulocytosis 17.75 9.86 11 103908 21410 50479795
Heart rate increased 17.62 9.86 239 103680 77011 50424194
Peritonitis 17.55 9.86 5 103914 15481 50485724
Meningitis aseptic 17.55 9.86 31 103888 4121 50497084
Eyelid ptosis 17.45 9.86 39 103880 6148 50495057
Punctate keratitis 17.35 9.86 12 103907 545 50500660
Phrenic nerve paralysis 17.32 9.86 7 103912 102 50501103
Enzyme induction 17.24 9.86 6 103913 56 50501149
Systolic anterior motion of mitral valve 17.21 9.86 5 103914 24 50501181
Extremity necrosis 17.15 9.86 18 103901 1453 50499752
Product measured potency issue 17.14 9.86 7 103912 105 50501100
Retinal artery occlusion 16.99 9.86 18 103901 1469 50499736
Hypocalcaemia 16.95 9.86 18 103901 26798 50474407
Apnoeic attack 16.80 9.86 9 103910 256 50500949
Sinus operation 16.72 9.86 19 103900 1677 50499528
Vocal cord dysfunction 16.68 9.86 10 103909 354 50500851
Glossoptosis 16.62 9.86 6 103913 63 50501142
Sleep disorder 16.59 9.86 61 103858 57222 50443983
No adverse event 16.58 9.86 122 103797 33456 50467749
Poor quality sleep 16.58 9.86 73 103846 16573 50484632
Inability to afford medication 16.56 9.86 18 103901 1512 50499693
Abdominal pain 16.34 9.86 365 103554 235863 50265342
White blood cell count decreased 16.30 9.86 157 103762 116565 50384640
ECG signs of myocardial ischaemia 16.21 9.86 6 103913 68 50501137
Infusion site discolouration 16.16 9.86 12 103907 610 50500595
Arachnoiditis 16.15 9.86 9 103910 277 50500928
Accidental overdose 16.05 9.86 81 103838 19452 50481753
Propofol infusion syndrome 16.03 9.86 13 103906 753 50500452
Muscle tightness 15.99 9.86 52 103867 10228 50490977
Brain injury 15.95 9.86 37 103882 5977 50495228
Neoplasm progression 15.86 9.86 22 103897 29135 50472070
Cold sweat 15.81 9.86 53 103866 10591 50490614
Vaccination complication 15.65 9.86 13 103906 779 50500426
Gastrointestinal disorder 15.43 9.86 122 103797 94334 50406871
Therapeutic product effect prolonged 15.40 9.86 9 103910 304 50500901
Depressed mood 15.38 9.86 29 103890 33994 50467211
Gastrointestinal haemorrhage 15.32 9.86 88 103831 73233 50427972
Adverse event 15.18 9.86 43 103876 43720 50457485
Respiratory distress 15.18 9.86 111 103808 30378 50470827
Rash 15.18 9.86 739 103180 436732 50064473
Interstitial lung disease 15.16 9.86 57 103862 53119 50448086
Product adhesion issue 15.08 9.86 30 103889 4362 50496843
Spinal epidural haematoma 15.06 9.86 14 103905 975 50500230
Eye infarction 15.05 9.86 5 103914 40 50501165
Distributive shock 14.98 9.86 13 103906 827 50500378
Prescribed underdose 14.95 9.86 7 103912 15942 50485263
Tooth infection 14.91 9.86 63 103856 14049 50487156
Musculoskeletal pain 14.88 9.86 87 103832 72090 50429115
Pneumonia mycoplasmal 14.86 9.86 13 103906 836 50500369
Gastric infection 14.85 9.86 24 103895 2968 50498237
Myocardial necrosis marker increased 14.85 9.86 17 103902 1513 50499692
Blood pressure increased 14.80 9.86 368 103551 132764 50368441
Respiratory tract oedema 14.78 9.86 10 103909 438 50500767
Eye inflammation 14.76 9.86 29 103890 4179 50497026
Platelet count decreased 14.70 9.86 134 103785 100592 50400613
Respiratory depression 14.59 9.86 56 103863 11954 50489251
Infusion site induration 14.55 9.86 13 103906 860 50500345
Cardiac assistance device user 14.53 9.86 5 103914 45 50501160
Spinal cord infarction 14.51 9.86 8 103911 241 50500964
Accidental exposure to product by child 14.46 9.86 14 103905 1026 50500179
Meningitis 14.45 9.86 36 103883 6085 50495120
Administration site scar 14.43 9.86 5 103914 46 50501159
Apnoea 14.42 9.86 39 103880 6927 50494278
Hypercalcaemia 14.40 9.86 16 103903 23336 50477869
Postpartum disorder 14.36 9.86 4 103915 16 50501189
Status epilepticus 14.28 9.86 60 103859 13346 50487859
Epidural analgesia 14.25 9.86 5 103914 48 50501157
Delayed recovery from anaesthesia 14.19 9.86 12 103907 737 50500468
Visual acuity reduced 14.15 9.86 80 103839 20059 50481146
Mast cell activation syndrome 14.08 9.86 9 103910 358 50500847
Hypercapnia 14.00 9.86 30 103889 4597 50496608
SARS-CoV-2 test positive 13.86 9.86 30 103889 4629 50496576
Neuroleptic malignant syndrome 13.77 9.86 3 103916 11127 50490078
Tracheal deviation 13.72 9.86 5 103914 54 50501151
Constipation 13.69 9.86 284 103635 185424 50315781
Systolic dysfunction 13.69 9.86 16 103903 1456 50499749
Blood pressure immeasurable 13.67 9.86 14 103905 1098 50500107
Chondromalacia 13.67 9.86 8 103911 271 50500934
Forced vital capacity abnormal 13.64 9.86 4 103915 20 50501185
Trigeminal palsy 13.64 9.86 4 103915 20 50501185
Incision site rash 13.64 9.86 4 103915 20 50501185
Left ventricular dysfunction 13.60 9.86 50 103869 10456 50490749
Malabsorption from administration site 13.60 9.86 6 103913 110 50501095
Caffeine allergy 13.47 9.86 4 103915 21 50501184
Colour blindness 13.46 9.86 8 103911 279 50500926
Diplegia 13.42 9.86 13 103906 953 50500252
Supraventricular tachycardia 13.41 9.86 57 103862 12744 50488461
Normal newborn 13.40 9.86 37 103882 6654 50494551
Inadequate analgesia 13.36 9.86 21 103898 2537 50498668
Liver disorder 13.34 9.86 36 103883 37186 50464019
Foetal heart rate abnormal 13.34 9.86 10 103909 516 50500689
Arthritis 13.25 9.86 114 103805 86607 50414598
Gastroenteritis 13.24 9.86 17 103902 23264 50477941
Device use issue 13.21 9.86 18 103901 1911 50499294
Administration site rash 13.18 9.86 5 103914 61 50501144
Creatinine renal clearance decreased 13.17 9.86 4 103915 11877 50489328
Hypomagnesaemia 13.07 9.86 17 103902 23139 50478066
Spinal cord oedema 13.03 9.86 6 103913 122 50501083
Procedural haemorrhage 13.01 9.86 20 103899 2370 50498835
Post-anoxic myoclonus 12.89 9.86 4 103915 25 50501180
Pain in extremity 12.85 9.86 445 103474 272420 50228785
Therapeutic product effect incomplete 12.81 9.86 123 103796 91392 50409813
CSF pressure increased 12.81 9.86 6 103913 127 50501078
Irregular breathing 12.74 9.86 8 103911 308 50500897
Product distribution issue 12.63 9.86 11 103908 703 50500502
Product contamination 12.62 9.86 10 103909 560 50500645
Off label use 12.51 9.86 823 103096 473603 50027602
International normalised ratio increased 12.46 9.86 46 103873 43106 50458099
Nail bed tenderness 12.45 9.86 8 103911 321 50500884
Pain in jaw 12.43 9.86 39 103880 38389 50462816
Administration site mass 12.38 9.86 4 103915 29 50501176
Genital ulceration 12.36 9.86 9 103910 444 50500761
Vaccination site rash 12.29 9.86 3 103916 6 50501199
Anal sphincter atony 12.20 9.86 7 103912 228 50500977
Propionibacterium infection 12.15 9.86 4 103915 31 50501174
Metastases to liver 12.15 9.86 14 103905 20090 50481115
Smoke sensitivity 12.14 9.86 8 103911 335 50500870
Neutropenic sepsis 12.09 9.86 7 103912 14140 50487065
Inflammation 12.06 9.86 68 103851 56844 50444361
Limb injury 12.03 9.86 77 103842 20173 50481032
Hypoxia 12.00 9.86 159 103760 50964 50450241
Influenza 11.96 9.86 254 103665 89284 50411921
Malignant melanoma 11.96 9.86 3 103916 10105 50491100
Device issue 11.90 9.86 76 103843 19896 50481309
Device ineffective 11.87 9.86 6 103913 151 50501054
Poor quality product administered 11.85 9.86 21 103898 2798 50498407
Optic atrophy 11.80 9.86 13 103906 1109 50500096
Sinus bradycardia 11.78 9.86 56 103863 13127 50488078
Foetal exposure during pregnancy 11.77 9.86 24 103895 27335 50473870
Blindness 11.74 9.86 68 103851 17201 50484004
Cutis laxa 11.72 9.86 6 103913 155 50501050
Cholestasis of pregnancy 11.71 9.86 13 103906 1118 50500087
Poor venous access 11.58 9.86 47 103872 10293 50490912
Electrocardiogram U wave present 11.52 9.86 5 103914 88 50501117
Femur fracture 11.45 9.86 39 103880 37425 50463780
Application site alopecia 11.43 9.86 3 103916 9 50501196
Decreased ventricular preload 11.43 9.86 3 103916 9 50501196
Body dysmorphic disorder 11.43 9.86 7 103912 258 50500947
Urticaria chronic 11.42 9.86 9 103910 500 50500705
Procedural anxiety 11.34 9.86 10 103909 650 50500555
Mastocytosis 11.27 9.86 9 103910 510 50500695
Mental status changes 11.25 9.86 119 103800 36153 50465052
Vascular resistance systemic decreased 11.22 9.86 5 103914 94 50501111
Haematochezia 11.20 9.86 43 103876 39839 50461366
Bradycardia foetal 11.20 9.86 8 103911 383 50500822
XIIth nerve injury 11.19 9.86 3 103916 10 50501195
Fall 11.17 9.86 568 103351 334364 50166841
Orbital infection 11.16 9.86 4 103915 41 50501164
Capillary nail refill test abnormal 11.16 9.86 4 103915 41 50501164
Balance disorder 11.14 9.86 92 103827 70498 50430707
Cardiac arrest neonatal 11.12 9.86 5 103914 96 50501109
Gamma-glutamyltransferase increased 11.11 9.86 28 103891 29595 50471610
Autonomic neuropathy 11.11 9.86 12 103907 1001 50500204
Alanine aminotransferase increased 11.04 9.86 122 103797 88237 50412968
Exposure during pregnancy 11.02 9.86 326 103593 120689 50380516
Heart rate decreased 10.98 9.86 119 103800 36378 50464827
Tachypnoea 10.97 9.86 59 103860 14518 50486687
Epinephrine increased 10.97 9.86 3 103916 11 50501194
Foot deformity 10.95 9.86 14 103905 19196 50482009
Biopsy lung 10.94 9.86 6 103913 179 50501026
Lip disorder 10.94 9.86 13 103906 1204 50500001
Anaphylactoid syndrome of pregnancy 10.91 9.86 4 103915 44 50501161
Hepatic cirrhosis 10.88 9.86 12 103907 17565 50483640
Corneal abrasion 10.87 9.86 11 103908 851 50500354
Tremor 10.87 9.86 311 103608 114592 50386613
Food allergy 10.77 9.86 39 103880 8098 50493107
Injection site abscess 10.77 9.86 12 103907 1037 50500168
Infusion site oedema 10.71 9.86 9 103910 548 50500657
Ill-defined disorder 10.68 9.86 67 103852 54587 50446618
Transaminases increased 10.67 9.86 26 103893 27798 50473407
Paranasal cyst 10.67 9.86 7 103912 291 50500914
Neurotoxicity 10.65 9.86 59 103860 14681 50486524
Ventricular arrhythmia 10.64 9.86 22 103897 3287 50497918
Hypoxic-ischaemic encephalopathy 10.59 9.86 24 103895 3818 50497387
Overdose 10.59 9.86 274 103645 99453 50401752
Victim of spousal abuse 10.58 9.86 3 103916 13 50501192
Intraocular pressure increased 10.55 9.86 30 103889 5486 50495719
N-terminal prohormone brain natriuretic peptide 10.53 9.86 4 103915 49 50501156
Scar 10.41 9.86 50 103869 11768 50489437
Urticarial vasculitis 10.41 9.86 9 103910 570 50500635
Nystagmus 10.40 9.86 30 103889 5531 50495674
Melaena 10.38 9.86 25 103894 26839 50474366
Akinesia 10.29 9.86 14 103905 1485 50499720
Aplastic anaemia 10.26 9.86 37 103882 7666 50493539
Ehlers-Danlos syndrome 10.26 9.86 5 103914 116 50501089
Electrocardiogram P wave abnormal 10.23 9.86 6 103913 204 50501001
Arthritis fungal 10.23 9.86 3 103916 15 50501190
Coccygectomy 10.23 9.86 3 103916 15 50501190
Vitamin E decreased 10.23 9.86 3 103916 15 50501190
Tongue pruritus 10.22 9.86 8 103911 440 50500765
Eosinophilia 10.22 9.86 14 103905 18638 50482567
Quadriplegia 10.21 9.86 15 103904 1708 50499497
Airway complication of anaesthesia 10.20 9.86 6 103913 205 50501000
Arthritis bacterial 10.17 9.86 30 103889 5599 50495606
Diabetes mellitus 10.16 9.86 59 103860 48974 50452231
Anal skin tags 10.10 9.86 7 103912 319 50500886
Hyperlactacidaemia 10.07 9.86 18 103901 2415 50498790
Epidural haemorrhage 10.07 9.86 5 103914 121 50501084
Vitreous haemorrhage 10.04 9.86 15 103904 1733 50499472
Fear-related avoidance of activities 10.03 9.86 5 103914 122 50501083
Blood bilirubin increased 10.03 9.86 33 103886 32005 50469200
Gait disturbance 10.02 9.86 233 103686 149772 50351433
Drug hypersensitivity 10.00 9.86 620 103299 250390 50250815
Implant site swelling 9.98 9.86 8 103911 456 50500749
Compartment syndrome 9.97 9.86 16 103903 1966 50499239
Medical device site infection 9.97 9.86 6 103913 214 50500991
Product administration error 9.97 9.86 72 103847 19627 50481578
Depression 9.95 9.86 261 103658 165162 50336043
Infusion site scar 9.91 9.86 7 103912 329 50500876
Pupil fixed 9.91 9.86 14 103905 1538 50499667
Scarlet fever 9.88 9.86 5 103914 126 50501079

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
Device failure 358.07 10.60 137 55620 1879 29516891
Anaphylactic reaction 321.51 10.60 324 55433 27249 29491521
Sinusitis 274.40 10.60 331 55426 34019 29484751
Anaesthetic complication 249.52 10.60 87 55670 899 29517871
Drug ineffective 247.00 10.60 1338 54419 361832 29156938
Anaphylactic shock 217.63 10.60 189 55568 13147 29505623
Cardiac arrest 202.26 10.60 477 55280 85114 29433656
Toxic anterior segment syndrome 186.12 10.60 71 55686 965 29517805
Fear 165.87 10.60 140 55617 9364 29509406
Hereditary angioedema 161.74 10.60 59 55698 702 29518068
Chondrolysis 158.22 10.60 38 55719 78 29518692
Injury 154.40 10.60 185 55572 18861 29499909
Renal injury 141.60 10.60 132 55625 10070 29508700
Methaemoglobinaemia 135.36 10.60 76 55681 2595 29516175
Ventricular tachycardia 129.59 10.60 185 55572 22389 29496381
Hypotension 129.16 10.60 713 55044 193641 29325129
Anhedonia 117.36 10.60 102 55655 7098 29511672
Stress cardiomyopathy 115.69 10.60 58 55699 1566 29517204
Emotional distress 114.30 10.60 136 55621 13759 29505011
Accidental exposure to product 111.97 10.60 119 55638 10634 29508136
Ear infection 103.26 10.60 100 55657 8000 29510770
Injection site pallor 100.24 10.60 19 55738 0 29518770
Unevaluable event 98.84 10.60 191 55566 29660 29489110
Ventricular fibrillation 98.68 10.60 135 55622 15698 29503072
Needle issue 92.19 10.60 74 55683 4609 29514161
Infusion site swelling 91.49 10.60 52 55705 1818 29516952
Electrocardiogram ST segment elevation 90.61 10.60 72 55685 4420 29514350
Lagophthalmos 87.69 10.60 23 55734 77 29518693
Bradycardia 87.06 10.60 297 55460 65332 29453438
Infusion site pain 86.38 10.60 59 55698 2866 29515904
Local anaesthetic systemic toxicity 85.10 10.60 26 55731 169 29518601
Accidental exposure to product by child 83.84 10.60 44 55713 1310 29517460
Drug ineffective for unapproved indication 76.48 10.60 113 55644 14101 29504669
Product quality issue 75.14 10.60 119 55638 15776 29502994
Bronchospasm 74.04 10.60 91 55666 9518 29509252
Injection site laceration 73.35 10.60 16 55741 16 29518754
Expired product administered 72.07 10.60 52 55705 2759 29516011
Device use issue 67.07 10.60 23 55734 225 29518545
Diarrhoea 66.89 10.60 362 55395 332336 29186434
Injury associated with device 65.39 10.60 32 55725 819 29517951
Tachycardia 65.23 10.60 290 55467 72120 29446650
Upper respiratory tract infection 65.07 10.60 153 55604 27196 29491574
Arteriospasm coronary 62.47 10.60 46 55711 2519 29516251
Stress 59.83 10.60 128 55629 21362 29497408
Incorrect route of product administration 58.30 10.60 86 55671 10715 29508055
Infusion site extravasation 56.48 10.60 47 55710 3080 29515690
Pain 54.24 10.60 527 55230 170905 29347865
Vasoplegia syndrome 53.22 10.60 34 55723 1474 29517296
Hypoxic-ischaemic encephalopathy 52.93 10.60 52 55705 4232 29514538
Completed suicide 52.03 10.60 56 55701 90190 29428580
Endophthalmitis 51.84 10.60 43 55714 2805 29515965
Sinus tachycardia 51.80 10.60 98 55659 14971 29503799
General physical health deterioration 51.72 10.60 71 55686 102786 29415984
Injection site injury 51.36 10.60 18 55739 189 29518581
Shock 51.19 10.60 120 55637 21284 29497486
Unresponsive to stimuli 50.71 10.60 132 55625 24994 29493776
Pulse absent 48.71 10.60 54 55703 5059 29513711
Kounis syndrome 47.27 10.60 34 55723 1795 29516975
Metabolic acidosis 46.91 10.60 167 55590 37495 29481275
Electrocardiogram QRS complex prolonged 43.69 10.60 46 55711 4064 29514706
Decreased appetite 43.62 10.60 135 55622 145207 29373563
Wrong product administered 43.41 10.60 48 55709 4483 29514287
Infusion site erythema 43.16 10.60 31 55726 1633 29517137
Interstitial lung disease 41.53 10.60 29 55728 57689 29461081
Anxiety 40.68 10.60 288 55469 85077 29433693
Anaemia 40.61 10.60 218 55539 200733 29318037
Multiple organ dysfunction syndrome 40.02 10.60 229 55528 62887 29455883
Cardiogenic shock 39.94 10.60 102 55655 19088 29499682
Haemodynamic instability 38.92 10.60 61 55696 8012 29510758
Infusion site pruritus 38.27 10.60 19 55738 502 29518268
Accidental overdose 38.17 10.60 95 55662 17498 29501272
Mydriasis 38.08 10.60 52 55705 6033 29512737
Administration site pain 37.75 10.60 14 55743 175 29518595
Anaesthetic complication neurological 36.81 10.60 16 55741 309 29518461
Post procedural complication 36.25 10.60 68 55689 10321 29508449
Corneal reflex decreased 35.53 10.60 13 55744 156 29518614
Cardiotoxicity 35.06 10.60 44 55713 4700 29514070
Ventricular extrasystoles 34.14 10.60 67 55690 10515 29508255
Drug intolerance 33.89 10.60 25 55732 48354 29470416
Injection site coldness 33.79 10.60 8 55749 15 29518755
Urticaria 33.78 10.60 197 55560 54463 29464307
Disease progression 33.26 10.60 65 55692 81851 29436919
Procedural haemorrhage 32.56 10.60 30 55727 2253 29516517
Weight decreased 32.55 10.60 160 55597 150745 29368025
Delayed recovery from anaesthesia 32.43 10.60 19 55738 704 29518066
Generalised tonic-clonic seizure 32.12 10.60 94 55663 19045 29499725
Apnoea 32.08 10.60 48 55709 6054 29512716
Infusion site rash 31.96 10.60 15 55742 349 29518421
Medical device site laceration 31.65 10.60 6 55751 0 29518770
Eyelid rash 31.16 10.60 8 55749 24 29518746
Infusion site nodule 30.83 10.60 10 55747 81 29518689
Cauda equina syndrome 30.72 10.60 15 55742 382 29518388
Respiratory depression 30.37 10.60 74 55683 13449 29505321
Mean arterial pressure decreased 30.07 10.60 11 55746 132 29518638
Removal of foreign body 29.61 10.60 7 55750 13 29518757
Overdose 29.02 10.60 253 55504 79566 29439204
Oculocardiac reflex 29.01 10.60 9 55748 62 29518708
Asthenia 28.92 10.60 263 55494 214987 29303783
Hypoxia 28.78 10.60 170 55587 47209 29471561
Injection site hypoaesthesia 28.41 10.60 9 55748 67 29518703
Neutropenia 28.19 10.60 140 55617 131571 29387199
Leukopenia 27.83 10.60 38 55719 55165 29463605
Brain oedema 27.58 10.60 67 55690 12153 29506617
Blood pressure decreased 27.51 10.60 163 55594 45314 29473456
Pulseless electrical activity 27.46 10.60 46 55711 6388 29512382
Thrombocytopenia 27.34 10.60 146 55611 134677 29384093
Infusion related reaction 27.00 10.60 158 55599 43728 29475042
Laryngeal oedema 27 10.60 31 55726 3017 29515753
Acute kidney injury 26.86 10.60 346 55411 264921 29253849
Cyanosis 26.75 10.60 63 55694 11204 29507566
Corneal oedema 26.73 10.60 20 55737 1122 29517648
Hyperthermia malignant 26.53 10.60 24 55733 1760 29517010
Device malfunction 26.40 10.60 53 55704 8454 29510316
Incorrect drug administration rate 26.21 10.60 20 55737 1156 29517614
Spinal cord infarction 26.10 10.60 12 55745 266 29518504
Circulatory collapse 26.04 10.60 86 55671 18587 29500183
Electrocardiogram ST segment depression 26.03 10.60 26 55731 2159 29516611
Systolic anterior motion of mitral valve 25.92 10.60 7 55750 27 29518743
Malignant neoplasm progression 25.55 10.60 64 55693 73795 29444975
Angioedema 25.15 10.60 123 55634 31792 29486978
Death 24.93 10.60 475 55282 341609 29177161
Melaena 24.71 10.60 14 55743 31162 29487608
White blood cell count decreased 24.57 10.60 78 55679 83284 29435486
Toxicity to various agents 24.32 10.60 461 55296 173200 29345570
Trigemino-cardiac reflex 24.23 10.60 10 55747 169 29518601
Administration site swelling 23.96 10.60 10 55747 174 29518596
Hypopyon 23.73 10.60 12 55745 330 29518440
Loss of consciousness 23.51 10.60 228 55529 73828 29444942
Psoriasis 23.43 10.60 16 55741 32211 29486559
Injection site pain 23.43 10.60 122 55635 32324 29486446
Oedema peripheral 23.36 10.60 108 55649 103449 29415321
Tryptase increased 23.16 10.60 10 55747 190 29518580
Hyponatraemia 23.08 10.60 59 55698 67574 29451196
Cardiac failure congestive 23.03 10.60 71 55686 76510 29442260
Embolia cutis medicamentosa 23.01 10.60 10 55747 193 29518577
Respiratory arrest 22.88 10.60 103 55654 25730 29493040
Haemoglobin decreased 22.72 10.60 116 55641 108259 29410511
Anal sphincter atony 22.66 10.60 8 55749 86 29518684
Infusion site bruising 22.27 10.60 12 55745 377 29518393
Rheumatoid arthritis 22.02 10.60 17 55740 32135 29486635
Eye infection 21.72 10.60 27 55730 2856 29515914
Coronary artery disease 21.69 10.60 31 55726 44159 29474611
Pulmonary oedema 21.40 10.60 146 55611 42589 29476181
Platelet count decreased 21.40 10.60 113 55644 104559 29414211
Pancytopenia 21.05 10.60 83 55674 83085 29435685
Skin texture abnormal 20.96 10.60 6 55751 30 29518740
Liquid product physical issue 20.76 10.60 11 55746 334 29518436
Hyperdynamic left ventricle 20.56 10.60 8 55749 115 29518655
Atrioventricular block complete 20.34 10.60 46 55711 7965 29510805
Neuromuscular block prolonged 20.32 10.60 12 55745 451 29518319
Injection site discolouration 20.26 10.60 18 55739 1289 29517481
Dehydration 20.19 10.60 130 55627 114618 29404152
Administration site erythema 20.10 10.60 7 55750 72 29518698
Nasopharyngitis 20.08 10.60 186 55571 59479 29459291
Infusion site haemorrhage 20.03 10.60 14 55743 706 29518064
Chondromalacia 20.00 10.60 5 55752 13 29518757
Hypoglycaemia 19.93 10.60 38 55719 48308 29470462
Respiratory acidosis 19.89 10.60 32 55725 4296 29514474
Pupil fixed 19.87 10.60 20 55737 1676 29517094
Familial periodic paralysis 19.76 10.60 7 55750 76 29518694
Macroglossia 19.74 10.60 11 55746 370 29518400
Left ventricle outflow tract obstruction 19.72 10.60 8 55749 129 29518641
Aqueous fibrin 19.64 10.60 6 55751 39 29518731
Anterior chamber cell 19.61 10.60 10 55747 280 29518490
Procedural hypotension 19.54 10.60 15 55742 875 29517895
Diabetes mellitus 19.49 10.60 28 55729 39803 29478967
Agranulocytosis 19.45 10.60 7 55750 20333 29498437
Hypersensitivity 19.38 10.60 168 55589 52735 29466035
COVID-19 immunisation 19.34 10.60 8 55749 136 29518634
Hepatocellular injury 19.17 10.60 8 55749 21235 29497535
Intracranial hypotension 19.15 10.60 9 55748 210 29518560
Headache 18.86 10.60 445 55312 173562 29345208
Tubulointerstitial nephritis 18.80 10.60 5 55752 17638 29501132
Retinal artery occlusion 18.76 10.60 19 55738 1604 29517166
Eyelid oedema 18.28 10.60 32 55725 4604 29514166
Ophthalmoplegia 18.19 10.60 19 55738 1663 29517107
International normalised ratio increased 18.18 10.60 35 55722 44337 29474433
Vitritis 18.18 10.60 13 55744 680 29518090
Malaise 18.09 10.60 203 55554 159399 29359371
COVID-19 18.01 10.60 123 55634 35891 29482879
Phaeochromocytoma crisis 17.75 10.60 6 55751 56 29518714
Procedural complication 17.29 10.60 29 55728 4031 29514739
Cardiac arrest neonatal 17.15 10.60 5 55752 27 29518743
Reperfusion arrhythmia 17.12 10.60 6 55751 63 29518707
Coma 17.00 10.60 130 55627 39320 29479450
Croup infectious 16.87 10.60 9 55748 277 29518493
Dry gangrene 16.81 10.60 10 55747 381 29518389
Product adhesion issue 16.60 10.60 17 55740 1454 29517316
Dyspnoea exertional 16.56 10.60 27 55730 36463 29482307
Blindness 16.43 10.60 55 55702 11968 29506802
Paraplegia 16.38 10.60 22 55735 2512 29516258
Cytomegalovirus infection 16.25 10.60 12 55745 23203 29495567
Myalgia 16.21 10.60 78 55679 73941 29444829
Catecholamine crisis 16.17 10.60 5 55752 34 29518736
Administration site irritation 16.11 10.60 4 55753 10 29518760
Jaundice 15.97 10.60 19 55738 29277 29489493
Administration site scar 15.83 10.60 3 55754 0 29518770
Retinal vasculitis 15.82 10.60 9 55748 315 29518455
Myopathy toxic 15.79 10.60 10 55747 427 29518343
Hepatotoxicity 15.69 10.60 7 55750 17860 29500910
Blood pressure fluctuation 15.67 10.60 9 55748 19885 29498885
Vitreous floaters 15.63 10.60 24 55733 3097 29515673
Gastrointestinal haemorrhage 15.62 10.60 87 55670 79446 29439324
Injection site extravasation 15.54 10.60 21 55736 2412 29516358
Recalled product administered 15.48 10.60 10 55747 442 29518328
Myocardial stunning 15.34 10.60 4 55753 13 29518757
Pancreatitis acute 15.34 10.60 14 55743 24371 29494399
Anion gap 15.28 10.60 12 55745 724 29518046
Vitreous disorder 15.25 10.60 6 55751 89 29518681
Pallor 15.14 10.60 79 55678 20945 29497825
Injury corneal 15.11 10.60 4 55753 14 29518756
Sinus arrest 15.03 10.60 16 55741 1431 29517339
Abdominal pain 15.00 10.60 173 55584 135184 29383586
Areflexia 14.96 10.60 22 55735 2732 29516038
Accelerated idioventricular rhythm 14.95 10.60 6 55751 94 29518676
Infusion site mass 14.86 10.60 8 55749 251 29518519
Fatigue 14.80 10.60 470 55287 316351 29202419
Electrocardiogram T wave amplitude increased 14.66 10.60 5 55752 48 29518722
Factor V Leiden mutation 14.66 10.60 5 55752 48 29518722
Haematochezia 14.44 10.60 30 55727 36953 29481817
Corneal opacity 14.33 10.60 10 55747 503 29518267
Asthma 14.28 10.60 111 55646 33738 29485032
Angina pectoris 14.20 10.60 19 55738 27831 29490939
Food allergy 14.18 10.60 13 55744 970 29517800
Tracheitis 14.17 10.60 11 55746 652 29518118
Foreign body 14.10 10.60 13 55744 977 29517793
Gait disturbance 13.99 10.60 81 55676 73268 29445502
Respiratory distress 13.94 10.60 106 55651 32000 29486770
Skin infection 13.90 10.60 35 55722 6492 29512278
Transient ischaemic attack 13.89 10.60 14 55743 23256 29495514
Pulmonary fibrosis 13.85 10.60 6 55751 15576 29503194
Administration site pruritus 13.81 10.60 4 55753 21 29518749
General anaesthesia 13.75 10.60 3 55754 3 29518767
Electrocardiogram ST-T segment depression 13.75 10.60 3 55754 3 29518767
End-tidal CO2 decreased 13.75 10.60 3 55754 3 29518767
Pupillary reflex impaired 13.62 10.60 15 55742 1394 29517376
Infusion site irritation 13.60 10.60 7 55750 200 29518570
Oxygen saturation decreased 13.59 10.60 137 55620 44800 29473970
Rectal haemorrhage 13.51 10.60 28 55729 34521 29484249
Ventricular arrhythmia 13.48 10.60 28 55729 4576 29514194
Administration site reaction 13.45 10.60 5 55752 63 29518707
Blood lactic acid increased 13.42 10.60 32 55725 5734 29513036
Gas gangrene 13.38 10.60 5 55752 64 29518706
Paralysis 13.33 10.60 31 55726 5466 29513304
Seizure 13.28 10.60 248 55509 92875 29425895
Injection site joint infection 13.23 10.60 4 55753 25 29518745
Infusion site reaction 13.06 10.60 11 55746 733 29518037
Suicide attempt 13.04 10.60 28 55729 34082 29484688
Throat tightness 13.04 10.60 36 55721 7055 29511715
Cholestasis 13.02 10.60 15 55742 23447 29495323
Drug-induced liver injury 12.96 10.60 13 55744 21642 29497128
Visual acuity reduced 12.93 10.60 59 55698 14817 29503953
Intestinal haematoma 12.91 10.60 5 55752 71 29518699
Deep vein thrombosis 12.85 10.60 60 55697 57339 29461431
Retinal vascular occlusion 12.85 10.60 6 55751 138 29518632
Medication error 12.80 10.60 76 55681 21135 29497635
Product administered at inappropriate site 12.78 10.60 16 55741 1704 29517066
Nodal rhythm 12.67 10.60 14 55743 1306 29517464
Seizure like phenomena 12.55 10.60 10 55747 616 29518154
Optic nerve injury 12.54 10.60 5 55752 77 29518693
Haematuria 12.51 10.60 42 55715 44097 29474673
Compartment syndrome 12.48 10.60 19 55738 2433 29516337
Administration related reaction 12.25 10.60 5 55752 82 29518688
Anaphylactoid shock 12.22 10.60 8 55749 362 29518408
Myocardial infarction 12.20 10.60 141 55616 110155 29408615
Burkholderia test positive 12.11 10.60 12 55745 987 29517783
Sleep disorder 12.07 10.60 17 55740 24369 29494401
Myelosuppression 12.05 10.60 4 55753 12223 29506547
Myokymia 11.98 10.60 5 55752 87 29518683
Laryngeal stenosis 11.98 10.60 5 55752 87 29518683
Heart rate increased 11.91 10.60 119 55638 38819 29479951
Oral lichen planus 11.87 10.60 6 55751 165 29518605
Hepatitis 11.85 10.60 13 55744 20770 29498000
Drug resistance 11.71 10.60 14 55743 21526 29497244
Apgar score low 11.69 10.60 11 55746 848 29517922
Expired device used 11.68 10.60 4 55753 39 29518731
Brain stem syndrome 11.52 10.60 8 55749 399 29518371
Pharyngeal oedema 11.43 10.60 30 55727 5704 29513066
Eosinophilia 11.42 10.60 15 55742 22146 29496624
Eye inflammation 11.38 10.60 15 55742 1681 29517089
Fall 11.36 10.60 251 55506 176927 29341843
Status asthmaticus 11.35 10.60 7 55750 285 29518485
Pneumocystis jirovecii pneumonia 11.33 10.60 9 55748 16770 29502000
Oesophageal obstruction 11.28 10.60 8 55749 413 29518357
Spinal cord oedema 11.27 10.60 6 55751 184 29518586
Insomnia 11.22 10.60 110 55647 88651 29430119
Extrasystoles 11.21 10.60 22 55735 3452 29515318
Musculoskeletal stiffness 11.06 10.60 35 55722 37423 29481347
Cardiac failure 11.00 10.60 96 55661 79191 29439579
Device issue 11.00 10.60 36 55721 7744 29511026
Orthostatic hypotension 10.98 10.60 16 55741 22613 29496157
Quadriplegia 10.96 10.60 14 55743 1522 29517248
Neuromuscular blockade 10.95 10.60 6 55751 195 29518575
Drug interaction 10.91 10.60 286 55471 197099 29321671
Tonic convulsion 10.90 10.60 11 55746 925 29517845
Liver function test abnormal 10.84 10.60 24 55733 28894 29489876
Penile vascular disorder 10.83 10.60 3 55754 13 29518757
Alopecia 10.81 10.60 12 55745 19072 29499698
Respiratory tract infection 10.71 10.60 58 55699 15593 29503177
Posterior capsule rupture 10.65 10.60 3 55754 14 29518756

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 602.93 9.45 699 122534 67965 64307534
Stress cardiomyopathy 541.94 9.45 291 122942 8966 64366533
Toxic anterior segment syndrome 504.53 9.45 186 123047 2253 64373246
Anaesthetic complication 490.78 9.45 185 123048 2394 64373105
Cardiac arrest 450.98 9.45 943 122290 153121 64222378
Local anaesthetic systemic toxicity 401.08 9.45 115 123118 570 64374929
Anaphylactic shock 396.79 9.45 382 122851 29946 64345553
Hereditary angioedema 354.62 9.45 165 123068 3711 64371788
Device failure 341.78 9.45 182 123051 5510 64369989
Chondrolysis 296.83 9.45 78 123155 259 64375240
Hypotension 235.63 9.45 1385 121848 379589 63995910
Drug ineffective 228.76 9.45 2528 120705 837719 63537780
Fear 228.55 9.45 235 122998 19936 64355563
Ventricular tachycardia 225.41 9.45 302 122931 33963 64341536
Lagophthalmos 223.34 9.45 63 123170 291 64375208
Renal injury 204.90 9.45 196 123037 15233 64360266
Completed suicide 185.10 9.45 99 123134 224315 64151184
Bradycardia 183.98 9.45 570 122663 117649 64257850
Incorrect route of product administration 182.59 9.45 224 123009 23074 64352425
Anhedonia 176.14 9.45 171 123062 13535 64361964
Sinusitis 168.64 9.45 637 122596 145291 64230208
Injury 166.17 9.45 345 122888 55647 64319852
Ventricular fibrillation 164.17 9.45 215 123018 23645 64351854
Pulseless electrical activity 163.83 9.45 159 123074 12580 64362919
Bronchospasm 159.57 9.45 202 123031 21480 64354019
Kounis syndrome 157.43 9.45 88 123145 2937 64372562
Unevaluable event 149.71 9.45 311 122922 50178 64325321
Emotional distress 147.86 9.45 255 122978 35783 64339716
Methaemoglobinaemia 144.83 9.45 95 123138 4253 64371246
Drug intolerance 143.54 9.45 91 123142 187901 64187598
Accidental exposure to product 143.16 9.45 212 123021 26152 64349347
Product quality issue 135.78 9.45 221 123012 29578 64345921
Shock 130.73 9.45 250 122983 37990 64337509
Electrocardiogram ST segment elevation 129.63 9.45 109 123124 7150 64368349
Tachycardia 123.84 9.45 590 122643 148989 64226510
Joint swelling 123.04 9.45 138 123095 215244 64160255
Corneal oedema 118.78 9.45 67 123166 2276 64373223
Arteriospasm coronary 118.66 9.45 92 123141 5373 64370126
Contraindicated product administered 118.34 9.45 30 123203 107799 64267700
Endophthalmitis 113.63 9.45 89 123144 5276 64370223
General physical health deterioration 113.50 9.45 134 123099 204291 64171208
Cardiogenic shock 112.08 9.45 213 123020 32214 64343285
Urticaria 110.49 9.45 565 122668 146752 64228747
Injection site pallor 107.75 9.45 25 123208 40 64375459
Synovitis 106.02 9.45 29 123204 99061 64276438
Left ventricle outflow tract obstruction 103.35 9.45 34 123199 285 64375214
Diarrhoea 101.80 9.45 888 122345 721816 63653683
Rheumatoid arthritis 99.70 9.45 100 123133 164194 64211305
Pulse absent 99.12 9.45 103 123130 8843 64366656
Cauda equina syndrome 97.94 9.45 46 123187 1057 64374442
Hand deformity 96.01 9.45 6 123227 62765 64312734
Unresponsive to stimuli 94.68 9.45 260 122973 50133 64325366
Haemodynamic instability 92.84 9.45 128 123105 14784 64360715
Sinus tachycardia 92.75 9.45 196 123037 31992 64343507
Pemphigus 92.26 9.45 6 123227 60695 64314804
Hepatic enzyme increased 86.04 9.45 73 123160 129870 64245629
Generalised tonic-clonic seizure 85.42 9.45 216 123017 39641 64335858
Drug ineffective for unapproved indication 84.46 9.45 185 123048 30948 64344551
Infusion site swelling 81.37 9.45 74 123159 5391 64370108
Wrong product administered 80.40 9.45 86 123147 7634 64367865
Vasoplegia syndrome 79.11 9.45 55 123178 2712 64372787
Injection site ischaemia 78.40 9.45 16 123217 7 64375492
Injury associated with device 77.60 9.45 55 123178 2798 64372701
Arthralgia 77.44 9.45 511 122722 441749 63933750
Stridor 76.52 9.45 68 123165 4806 64370693
Hypopyon 76.51 9.45 38 123195 991 64374508
Pulmonary oedema 74.50 9.45 323 122910 78351 64297148
Expired product administered 73.76 9.45 73 123160 5914 64369585
Pericarditis 73.37 9.45 15 123218 62501 64312998
Maternal exposure during delivery 72.56 9.45 35 123198 855 64374644
Accidental exposure to product by child 72.47 9.45 50 123183 2435 64373064
Infusion site erythema 72.34 9.45 77 123156 6796 64368703
Systemic lupus erythematosus 72.02 9.45 29 123204 77583 64297916
Anaesthetic complication neurological 68.52 9.45 29 123204 516 64374983
Electrocardiogram ST segment depression 68.44 9.45 61 123172 4328 64371171
Anxiety 68.08 9.45 638 122595 202011 64173488
Glossodynia 67.23 9.45 20 123213 64676 64310823
Needle issue 66.03 9.45 85 123148 9187 64366312
Stress 63.94 9.45 257 122976 60277 64315222
Tryptase increased 62.84 9.45 26 123207 436 64375063
Infusion site extravasation 62.27 9.45 71 123162 6766 64368733
Post procedural complication 61.49 9.45 130 123103 21223 64354276
Hyponatraemia 61.26 9.45 119 123114 148220 64227279
Arthropathy 61.18 9.45 85 123148 120882 64254617
Mydriasis 61.03 9.45 107 123126 15205 64360294
Decreased appetite 60.45 9.45 304 122929 280985 64094514
Eyelid rash 60.01 9.45 17 123216 80 64375419
Airway peak pressure increased 59.89 9.45 23 123210 314 64375185
Alopecia 59.26 9.45 144 123089 165546 64209953
Upper respiratory tract infection 58.65 9.45 285 122948 72500 64302999
Asthenia 58.27 9.45 530 122703 427514 63947985
Anaemia 58.24 9.45 454 122779 378226 63997273
Multiple organ dysfunction syndrome 58.13 9.45 362 122871 101051 64274448
Abdominal discomfort 57.97 9.45 168 123065 182154 64193345
Procedural hypotension 57.49 9.45 39 123194 1847 64373652
Neutropenia 57.36 9.45 249 122984 239375 64136124
Metabolic acidosis 57.29 9.45 278 122955 70680 64304819
Injection site injury 57.19 9.45 27 123206 628 64374871
Cyanosis 57.11 9.45 129 123104 22026 64353473
Acute kidney injury 56.58 9.45 567 122666 448673 63926826
Accidental overdose 56.08 9.45 166 123067 33391 64342108
Circulatory collapse 55.55 9.45 166 123067 33566 64341933
Helicobacter infection 54.89 9.45 5 123228 38357 64337142
Extradural abscess 54.87 9.45 32 123201 1159 64374340
Vitritis 54.76 9.45 35 123198 1498 64374001
Blood pressure decreased 53.41 9.45 314 122919 85885 64289614
Cataract operation complication 53.17 9.45 20 123213 257 64375242
Angioedema 52.66 9.45 246 122987 61575 64313924
Hypoxic-ischaemic encephalopathy 51.62 9.45 66 123167 7086 64368413
Anterior chamber cell 51.31 9.45 27 123206 797 64374702
Injection site laceration 51.26 9.45 16 123217 111 64375388
Ophthalmoplegia 51.21 9.45 42 123191 2660 64372839
Seizure 50.91 9.45 515 122718 166377 64209122
Peripheral ischaemia 50.78 9.45 71 123162 8307 64367192
Removal of foreign body 50.01 9.45 12 123221 24 64375475
Body tinea 49.89 9.45 31 123202 1262 64374237
Electrocardiogram QRS complex prolonged 49.69 9.45 74 123159 9170 64366329
Injection site coldness 49.64 9.45 15 123218 92 64375407
Extradural haematoma 49.47 9.45 41 123192 2635 64372864
Infusion site pruritus 48.33 9.45 40 123193 2566 64372933
Lower respiratory tract infection 48.33 9.45 66 123167 94548 64280951
Musculoskeletal stiffness 47.34 9.45 103 123130 123103 64252396
Infusion site pain 47.20 9.45 77 123156 10320 64365179
Incorrect drug administration rate 46.85 9.45 40 123193 2679 64372820
Ventricular extrasystoles 46.23 9.45 103 123130 17426 64358073
Disease progression 46.17 9.45 129 123104 141551 64233948
Wound 45.85 9.45 47 123186 76430 64299069
Apnoea 45.72 9.45 76 123157 10346 64365153
Impaired quality of life 45.58 9.45 59 123174 6412 64369087
Therapeutic product effect decreased 45.51 9.45 95 123138 115256 64260243
Mean arterial pressure decreased 45.31 9.45 19 123214 330 64375169
Hyperaesthesia 45.24 9.45 74 123159 9940 64365559
Overdose 45.17 9.45 485 122748 159081 64216418
Respiratory depression 45.06 9.45 122 123111 23321 64352178
Loss of consciousness 44.85 9.45 457 122776 147908 64227591
Respiratory acidosis 44.76 9.45 73 123160 9782 64365717
Trigemino-cardiac reflex 44.61 9.45 17 123216 227 64375272
Systolic anterior motion of mitral valve 44.54 9.45 12 123221 45 64375454
Neuromuscular block prolonged 44.35 9.45 26 123207 951 64374548
Ear infection 44.19 9.45 121 123112 23283 64352216
Thrombocytopenia 44.09 9.45 249 122984 223552 64151947
Intentional self-injury 43.75 9.45 3 123230 29041 64346458
Swollen tongue 43.17 9.45 156 123077 34798 64340701
Interstitial lung disease 42.46 9.45 76 123157 97656 64277843
Leukopenia 41.98 9.45 81 123152 101161 64274338
Myopathy toxic 41.97 9.45 24 123209 837 64374662
Status asthmaticus 41.95 9.45 25 123208 943 64374556
Hypoxia 41.69 9.45 300 122933 87849 64287650
Ventricular hypokinesia 41.49 9.45 62 123171 7707 64367792
Retinal artery occlusion 40.68 9.45 38 123195 2865 64372634
Pharyngeal oedema 40.66 9.45 91 123142 15440 64360059
Retinal vasculitis 40.51 9.45 26 123207 1121 64374378
Delayed recovery from anaesthesia 40.50 9.45 29 123204 1499 64374000
Device use issue 40.10 9.45 31 123202 1802 64373697
Pancytopenia 39.97 9.45 140 123093 143169 64232330
Nerve root injury 39.86 9.45 10 123223 26 64375473
Malignant neoplasm progression 39.63 9.45 99 123134 112772 64262727
Spinal cord infarction 39.17 9.45 20 123213 554 64374945
Injection site hypoaesthesia 39.08 9.45 18 123215 395 64375104
Infusion site mass 39.07 9.45 24 123209 957 64374542
Procedural haemorrhage 38.46 9.45 44 123189 4208 64371291
Aqueous fibrin 38.41 9.45 13 123220 120 64375379
Cholestasis 38.12 9.45 19 123214 44853 64330646
Paralysis 37.41 9.45 74 123159 11521 64363978
Procedural complication 37.40 9.45 57 123176 7208 64368291
Lip swelling 37.38 9.45 140 123093 31767 64343732
Laryngeal oedema 36.89 9.45 56 123177 7057 64368442
Medical device site laceration 36.84 9.45 7 123226 0 64375499
Cardiac failure congestive 36.80 9.45 127 123106 130453 64245046
Anaphylactoid shock 36.71 9.45 21 123212 733 64374766
Hypoaesthesia oral 36.28 9.45 73 123160 11507 64363992
Sleep disorder due to general medical condition, insomnia type 36.08 9.45 4 123229 26266 64349233
Product adhesion issue 36.03 9.45 33 123200 2426 64373073
Infusion site bruising 35.92 9.45 27 123206 1505 64373994
Troponin I increased 35.34 9.45 40 123193 3781 64371718
Drug reaction with eosinophilia and systemic symptoms 35.21 9.45 31 123202 54186 64321313
Chondromalacia 34.99 9.45 13 123220 161 64375338
Paraplegia 34.90 9.45 43 123190 4447 64371052
Uterine hypertonus 34.72 9.45 14 123219 219 64375280
Fall 34.63 9.45 574 122659 416252 63959247
Bronchitis 34.32 9.45 338 122895 108405 64267094
Agranulocytosis 34.31 9.45 15 123218 38214 64337285
Gas gangrene 34.27 9.45 14 123219 227 64375272
Toxicity to various agents 34.24 9.45 923 122310 362590 64012909
Folliculitis 33.70 9.45 8 123225 30069 64345430
Cardiotoxicity 33.67 9.45 66 123167 10208 64365291
Product contamination microbial 33.64 9.45 21 123212 862 64374637
Anal sphincter atony 33.39 9.45 15 123218 310 64375189
Bladder prolapse 33.37 9.45 23 123210 1118 64374381
Paraesthesia oral 33.33 9.45 76 123157 13055 64362444
COVID-19 33.32 9.45 226 123007 64914 64310585
Infection susceptibility increased 33.14 9.45 33 123200 2693 64372806
Fear of eating 32.87 9.45 16 123217 399 64375100
Meningitis chemical 32.86 9.45 13 123220 193 64375306
Fatigue 32.77 9.45 1137 122096 747593 63627906
Throat tightness 32.63 9.45 108 123125 23052 64352447
Orthostatic hypotension 32.49 9.45 25 123208 46713 64328786
Weight decreased 32.13 9.45 370 122863 285369 64090130
C-reactive protein abnormal 32.01 9.45 8 123225 29039 64346460
Blood creatinine increased 31.91 9.45 142 123091 135640 64239859
Muscle injury 31.74 9.45 6 123227 26431 64349068
Peripheral nerve injury 31.74 9.45 18 123215 618 64374881
Blood lactic acid increased 30.73 9.45 64 123169 10337 64365162
Respiratory distress 30.72 9.45 188 123045 52143 64323356
Type I hypersensitivity 30.68 9.45 36 123197 3538 64371961
Hepatocellular injury 30.43 9.45 25 123208 45210 64330289
Visual acuity reduced 30.08 9.45 117 123116 27024 64348475
Asthma 30.05 9.45 296 122937 94929 64280570
Anaphylactoid reaction 29.99 9.45 41 123192 4697 64370802
Myocardial ischaemia 29.76 9.45 105 123128 23146 64352353
Wheezing 29.72 9.45 259 122974 80320 64295179
Blindness 29.54 9.45 101 123132 21918 64353581
Platelet aggregation inhibition 29.34 9.45 11 123222 140 64375359
Corneal reflex decreased 29.29 9.45 14 123219 335 64375164
Psoriasis 29.17 9.45 58 123175 71645 64303854
Electrocardiogram T wave inversion 28.96 9.45 41 123192 4853 64370646
Oculocardiac reflex 28.89 9.45 9 123224 62 64375437
Mobility decreased 28.82 9.45 77 123156 85763 64289736
Melaena 28.73 9.45 36 123197 53512 64321987
Hyperdynamic left ventricle 28.53 9.45 13 123220 278 64375221
Sensory loss 28.23 9.45 61 123172 10108 64365391
Impaired healing 28.13 9.45 45 123188 60428 64315071
COVID-19 immunisation 27.80 9.45 16 123217 565 64374934
Blood pH decreased 27.72 9.45 38 123195 4364 64371135
Abdominal pain upper 27.71 9.45 208 123025 174822 64200677
Abdominal pain 27.65 9.45 425 122808 311950 64063549
Confusional state 27.13 9.45 344 122889 260800 64114699
Hepatotoxicity 26.99 9.45 22 123211 39940 64335559
Upper airway obstruction 26.92 9.45 21 123212 1237 64374262
Drug resistance 26.75 9.45 17 123216 35085 64340414
Haematochezia 26.73 9.45 54 123179 66319 64309180
Hyperthermia malignant 26.68 9.45 28 123205 2431 64373068
Jaundice 26.67 9.45 32 123201 48480 64327019
Harlequin syndrome 25.69 9.45 8 123225 55 64375444
Nerve block 25.40 9.45 13 123220 362 64375137
Corneal epithelium defect 25.37 9.45 16 123217 669 64374830
Oedema peripheral 25.35 9.45 268 122965 210049 64165450
Vasospasm 25.32 9.45 18 123215 920 64374579
Familial periodic paralysis 25.24 9.45 10 123223 149 64375350
Pupil fixed 25.20 9.45 31 123202 3201 64372298
Death 25.18 9.45 716 122517 481989 63893510
Tubulointerstitial nephritis 24.91 9.45 14 123219 30895 64344604
Spinal anaesthesia 24.75 9.45 8 123225 63 64375436
Respiratory failure 24.67 9.45 439 122794 160744 64214755
Illness 24.66 9.45 95 123138 21843 64353656
Status epilepticus 24.51 9.45 94 123139 21569 64353930
Psoriatic arthropathy 24.38 9.45 28 123205 43253 64332246
Product administration error 24.27 9.45 111 123122 27532 64347967
Infusion site urticaria 24.24 9.45 15 123218 606 64374893
Extremity necrosis 24.24 9.45 28 123205 2706 64372793
Vasoconstriction 24.09 9.45 15 123218 613 64374886
Sinus bradycardia 24.01 9.45 97 123136 22796 64352703
Atrioventricular block complete 23.78 9.45 71 123162 14347 64361152
PCO2 increased 23.70 9.45 22 123211 1645 64373854
Liver function test abnormal 23.35 9.45 49 123184 59352 64316147
Spinal cord oedema 23.19 9.45 12 123221 342 64375157
Peripheral swelling 23.04 9.45 272 122961 208881 64166618
Gastrointestinal haemorrhage 23.01 9.45 153 123080 132159 64243340
Compartment syndrome 22.92 9.45 34 123199 4198 64371301
PO2 decreased 22.75 9.45 27 123206 2686 64372813
Type 2 diabetes mellitus 22.64 9.45 19 123214 34001 64341498
Respiratory arrest 22.59 9.45 176 123057 52809 64322690
White blood cell count decreased 22.48 9.45 193 123040 157644 64217855
Lung hyperinflation 22.39 9.45 21 123212 1591 64373908
Propofol infusion syndrome 22.34 9.45 21 123212 1596 64373903
International normalised ratio increased 22.29 9.45 77 123156 79090 64296409
Supraventricular tachycardia 22.18 9.45 83 123150 18824 64356675
Eosinophilia 22.14 9.45 24 123209 38052 64337447
Cytomegalovirus infection 22.13 9.45 23 123210 37176 64338323
Embolia cutis medicamentosa 22.02 9.45 13 123220 482 64375017
Coronary artery disease 22 9.45 52 123181 60381 64315118
Fear of death 21.80 9.45 19 123214 1308 64374191
Phrenic nerve paralysis 21.77 9.45 10 123223 218 64375281
Eyelid oedema 21.72 9.45 62 123171 12217 64363282
Bursitis infective 21.39 9.45 18 123215 1182 64374317
Foreign body 21.33 9.45 25 123208 2454 64373045
Sleep disorder 21.24 9.45 52 123181 59657 64315842
Ventricular arrhythmia 21.18 9.45 45 123188 7370 64368129
Rectal prolapse 21.18 9.45 21 123212 1705 64373794
Brain oedema 21.16 9.45 91 123142 21984 64353515
Administration site swelling 21.11 9.45 11 123222 318 64375181
Drug abuse 21.09 9.45 157 123076 132217 64243282
Pharyngeal swelling 21.06 9.45 38 123195 5521 64369978
Infusion site haemorrhage 21.01 9.45 24 123209 2291 64373208
Gastrointestinal disorder 20.96 9.45 94 123139 89615 64285884
Platelet count decreased 20.91 9.45 212 123021 167499 64208000
Inhibitory drug interaction 20.89 9.45 30 123203 3597 64371902
Abortion spontaneous 20.83 9.45 11 123222 25132 64350367
Eye inflammation 20.75 9.45 35 123198 4822 64370677
Pallor 20.70 9.45 136 123097 38645 64336854
Parophthalmia 20.68 9.45 11 123222 332 64375167
C-reactive protein increased 20.67 9.45 102 123131 94807 64280692
Glucose tolerance impaired 20.64 9.45 41 123192 6402 64369097
Eye infection 20.62 9.45 51 123182 9230 64366269
Infusion site nodule 20.59 9.45 10 123223 248 64375251
Diabetes mellitus 20.56 9.45 62 123171 66412 64309087
Quadriplegia 20.49 9.45 27 123206 2986 64372513
Dry gangrene 20.32 9.45 15 123218 813 64374686
Apnoeic attack 20.30 9.45 13 123220 558 64374941
Intracranial hypotension 20.30 9.45 11 123222 345 64375154
Axillary nerve injury 20.22 9.45 5 123228 12 64375487
Pupillary reflex impaired 20.07 9.45 27 123206 3046 64372453
Product preparation error 20.02 9.45 31 123202 3974 64371525
Device ineffective 19.79 9.45 8 123225 126 64375373
Punctate keratitis 19.74 9.45 15 123218 850 64374649
Pain in extremity 19.71 9.45 435 122798 302650 64072849
Aplastic anaemia 19.69 9.45 65 123168 13855 64361644
Inappropriate antidiuretic hormone secretion 19.60 9.45 9 123224 22280 64353219
Ischaemia 19.45 9.45 43 123190 7235 64368264
Food allergy 19.44 9.45 45 123188 7806 64367693
Hypoglycaemia 19.35 9.45 97 123136 89795 64285704
Atonic urinary bladder 19.35 9.45 7 123226 80 64375419
Administration site pain 19.18 9.45 11 123222 386 64375113
Reversible cerebral vasoconstriction syndrome 19.13 9.45 23 123210 2319 64373180
Poor quality product administered 19.12 9.45 27 123206 3188 64372311
Neuromuscular blockade 19.02 9.45 12 123221 502 64374997
Systemic toxicity 18.97 9.45 7 123226 85 64375414
Accelerated idioventricular rhythm 18.77 9.45 8 123225 145 64375354
Eyelid ptosis 18.74 9.45 50 123183 9475 64366024
Device malfunction 18.72 9.45 75 123158 17558 64357941
Liver disorder 18.56 9.45 47 123186 53304 64322195
Heart rate increased 18.53 9.45 278 122955 98397 64277102
Sinus arrest 18.45 9.45 26 123207 3064 64372435
Renal failure 18.42 9.45 466 122767 181222 64194277
Arthritis bacterial 18.40 9.45 44 123189 7795 64367704
Arterial spasm 18.33 9.45 8 123225 154 64375345
Product administered at inappropriate site 18.32 9.45 26 123207 3084 64372415
Blood cholesterol increased 18.29 9.45 43 123190 50023 64325476
Progressive multifocal leukoencephalopathy 18.29 9.45 6 123227 18226 64357273
Osteonecrosis of jaw 18.18 9.45 30 123203 39795 64335704
Pneumocephalus 18.08 9.45 9 123224 236 64375263
Hypercalcaemia 18.05 9.45 20 123213 31396 64344103
Pancreatitis acute 18.01 9.45 34 123199 42821 64332678
Constipation 17.97 9.45 319 122914 229018 64146481
Treatment failure 17.93 9.45 140 123093 116676 64258823
Hypercapnia 17.86 9.45 43 123190 7651 64367848
Red blood cell sedimentation rate increased 17.82 9.45 20 123213 31215 64344284
Neurotoxicity 17.73 9.45 101 123132 27303 64348196
Depressed mood 17.71 9.45 32 123201 40980 64334519
Injection site inflammation 17.62 9.45 26 123207 3195 64372304
Troponin T increased 17.43 9.45 22 123211 2331 64373168
Postpartum disorder 17.40 9.45 4 123229 6 64375493
Mental status changes 17.33 9.45 186 123047 60976 64314523
Brain injury 17.32 9.45 50 123183 9915 64365584
Malaise 17.19 9.45 602 122631 395645 63979854
Migraine 17.02 9.45 189 123044 62488 64313011
No adverse event 17.01 9.45 103 123130 28458 64347041
Glossoptosis 16.95 9.45 8 123225 186 64375313
Infection 16.86 9.45 250 122983 184630 64190869
Tracheal deviation 16.79 9.45 6 123227 66 64375433
Injection site joint infection 16.78 9.45 5 123228 29 64375470
Neoplasm progression 16.78 9.45 33 123200 40931 64334568
Pneumocystis jirovecii pneumonia 16.54 9.45 17 123216 27617 64347882
Infusion site rash 16.51 9.45 15 123218 1091 64374408
Metastases to liver 16.39 9.45 13 123220 23928 64351571
Retinal vascular occlusion 16.37 9.45 11 123222 513 64374986
Epinephrine increased 16.35 9.45 4 123229 9 64375490
Weight increased 16.33 9.45 298 122935 213050 64162449
Monoplegia 16.31 9.45 26 123207 3417 64372082
Dehydration 16.20 9.45 304 122929 216459 64159040
Blindness cortical 16.17 9.45 13 123220 800 64374699
Phaeochromocytoma crisis 16.16 9.45 9 123224 298 64375201
Pulmonary fibrosis 16.12 9.45 20 123213 29858 64345641
Inadequate analgesia 16.11 9.45 28 123205 3950 64371549
Catecholamine crisis 16.11 9.45 5 123228 34 64375465
Neurogenic shock 16.08 9.45 11 123222 528 64374971
Cardiopulmonary failure 15.98 9.45 36 123197 6134 64369365
Normal newborn 15.94 9.45 34 123199 5583 64369916
Postresuscitation encephalopathy 15.86 9.45 5 123228 36 64375463
Irregular breathing 15.79 9.45 10 123223 421 64375078
Drug-induced liver injury 15.79 9.45 43 123190 47600 64327899
Application site pallor 15.79 9.45 3 123230 0 64375499
Hypercatabolism 15.79 9.45 3 123230 0 64375499
Liquid product physical issue 15.77 9.45 13 123220 829 64374670
Ascites 15.69 9.45 63 123170 61938 64313561
Meningitis 15.66 9.45 43 123190 8286 64367213
Condition aggravated 15.65 9.45 568 122665 371858 64003641
Abnormal behaviour 15.65 9.45 25 123208 33597 64341902
Balance disorder 15.64 9.45 95 123138 83831 64291668
Stomatitis 15.61 9.45 134 123099 109471 64266028
Left ventricular dysfunction 15.57 9.45 69 123164 16885 64358614
Spinal epidural haemorrhage 15.48 9.45 7 123226 147 64375352
Peritonitis 15.43 9.45 15 123218 25008 64350491
Hip arthroplasty 15.38 9.45 11 123222 21340 64354159
Obstructive airways disorder 15.36 9.45 86 123147 23099 64352400
Application site alopecia 15.29 9.45 4 123229 13 64375486
Respiratory tract infection 15.26 9.45 123 123110 37284 64338215
Skin test positive 15.17 9.45 14 123219 1039 64374460
Liver injury 15.16 9.45 21 123212 29911 64345588
Diplegia 15.13 9.45 17 123216 1594 64373905
Swelling face 14.98 9.45 176 123057 58990 64316509
Procedural pain 14.92 9.45 64 123169 15444 64360055
Gastroenteritis 14.89 9.45 21 123212 29690 64345809
ECG signs of myocardial ischaemia 14.85 9.45 9 123224 350 64375149
Graft versus host disease 14.85 9.45 4 123229 13809 64361690
Foetal heart rate abnormal 14.85 9.45 8 123225 248 64375251
Vitamin D increased 14.81 9.45 10 123223 470 64375029
Cholestasis of pregnancy 14.71 9.45 13 123220 912 64374587
Capillary nail refill test abnormal 14.69 9.45 5 123228 47 64375452
Myocardial necrosis marker increased 14.61 9.45 22 123211 2753 64372746
Tracheitis 14.56 9.45 15 123218 1275 64374224
Hypomagnesaemia 14.55 9.45 31 123202 37345 64338154
Blood pressure increased 14.49 9.45 432 122801 172120 64203379
Haemoglobin decreased 14.44 9.45 274 122959 194789 64180710
Epidural analgesia 14.42 9.45 5 123228 50 64375449
Cold sweat 14.39 9.45 66 123167 16389 64359110
Cranial nerve palsies multiple 14.32 9.45 6 123227 104 64375395
Gait disturbance 14.28 9.45 237 122996 171918 64203581
Scar 14.23 9.45 57 123176 13341 64362158
Diabetes mellitus inadequate control 14.07 9.45 12 123221 21309 64354190
Enzyme induction 14.06 9.45 6 123227 109 64375390
Creatinine renal clearance decreased 14.02 9.45 5 123228 14416 64361083
Acute pulmonary oedema 14.01 9.45 55 123178 12754 64362745
Torsade de pointes 13.99 9.45 68 123165 17295 64358204
Therapeutic product effect prolonged 13.96 9.45 10 123223 517 64374982
Eye infection intraocular 13.92 9.45 4 123229 20 64375479
Trigeminal palsy 13.92 9.45 4 123229 20 64375479
Incision site rash 13.92 9.45 4 123229 20 64375479
Myelosuppression 13.88 9.45 15 123218 23815 64351684
Exposure during pregnancy 13.87 9.45 217 123016 77458 64298041
Hypercholesterolaemia 13.85 9.45 6 123227 15367 64360132
Gamma-glutamyltransferase increased 13.78 9.45 47 123186 48463 64327036
Forced vital capacity abnormal 13.76 9.45 4 123229 21 64375478
Caffeine allergy 13.76 9.45 4 123229 21 64375478
Air embolism 13.72 9.45 9 123224 403 64375096
Airway complication of anaesthesia 13.72 9.45 9 123224 403 64375096
Removal of foreign body from throat 13.71 9.45 3 123230 3 64375496
Laryngospasm 13.63 9.45 24 123209 3421 64372078
Skin ulcer 13.61 9.45 41 123192 43933 64331566
Atrophy of globe 13.60 9.45 5 123228 60 64375439
Product use issue 13.54 9.45 206 123027 151509 64223990
Post lumbar puncture syndrome 13.53 9.45 11 123222 688 64374811
Radiculopathy 13.47 9.45 32 123201 5646 64369853
Cardiac assistance device user 13.45 9.45 5 123228 62 64375437
Pupillary light reflex tests abnormal 13.42 9.45 8 123225 302 64375197
SARS-CoV-2 test positive 13.39 9.45 34 123199 6252 64369247
Staphylococcal infection 13.39 9.45 152 123081 50526 64324973
Amaurosis 13.36 9.45 13 123220 1031 64374468
Cardio-respiratory arrest 13.32 9.45 263 122970 98130 64277369
Bone marrow failure 13.26 9.45 47 123186 47905 64327594
Disease recurrence 13.24 9.45 25 123208 31485 64344014
Spinal epidural haematoma 13.22 9.45 14 123219 1228 64374271
Neuroleptic malignant syndrome 13.20 9.45 17 123216 24979 64350520
Neutropenic sepsis 13.17 9.45 15 123218 23257 64352242
Conjunctival oedema 13.16 9.45 13 123220 1051 64374448
Diabetic ketoacidosis 13.14 9.45 23 123210 29822 64345677
Rectal haemorrhage 13.14 9.45 67 123166 61750 64313749
Respiratory tract oedema 13.11 9.45 11 123222 719 64374780
Optic nerve injury 13.09 9.45 10 123223 571 64374928
Macroglossia 13.07 9.45 13 123220 1059 64374440
Obesity 13.06 9.45 12 123221 20550 64354949
Distributive shock 13.06 9.45 17 123216 1858 64373641
Vascular resistance systemic decreased 13.05 9.45 7 123226 215 64375284
Post-anoxic myoclonus 13.04 9.45 4 123229 26 64375473
Chest discomfort 13.03 9.45 302 122931 115804 64259695
Loss of personal independence in daily activities 12.99 9.45 83 123150 72371 64303128
Urticaria chronic 12.98 9.45 9 123224 442 64375057
Rheumatoid nodule 12.98 9.45 4 123229 12647 64362852
Arthritis infective 12.93 9.45 36 123197 6994 64368505
Palmar-plantar erythrodysaesthesia syndrome 12.88 9.45 22 123211 28797 64346702
Chemical burn 12.87 9.45 9 123224 448 64375051
Nail bed tenderness 12.87 9.45 8 123225 326 64375173
Allodynia 12.85 9.45 14 123219 1269 64374230
Discomfort 12.84 9.45 96 123137 80782 64294717
Oxidative stress 12.79 9.45 4 123229 28 64375471
Injury corneal 12.78 9.45 5 123228 72 64375427
Optic atrophy 12.74 9.45 16 123217 1687 64373812
Pharyngitis streptococcal 12.73 9.45 41 123192 8627 64366872
Anal ulcer 12.70 9.45 13 123220 1096 64374403
Immune reconstitution inflammatory syndrome 12.69 9.45 4 123229 12466 64363033
Nodal rhythm 12.66 9.45 21 123212 2853 64372646
Arthritis 12.60 9.45 101 123132 83713 64291786
Bundle branch block left 12.57 9.45 45 123188 9989 64365510
Nystagmus 12.52 9.45 42 123191 9026 64366473
Injection site necrosis 12.48 9.45 14 123219 1311 64374188
Rotator cuff syndrome 12.46 9.45 51 123182 12056 64363443
Schizophrenia 12.45 9.45 3 123230 11165 64364334
Foreign body in respiratory tract 12.40 9.45 8 123225 348 64375151
Hepatitis 12.39 9.45 45 123188 45537 64329962
Pneumonia mycoplasmal 12.38 9.45 14 123219 1322 64374177
Myelodysplastic syndrome 12.38 9.45 21 123212 27558 64347941
Tongue pruritus 12.34 9.45 9 123224 479 64375020
Vocal cord disorder 12.32 9.45 14 123219 1329 64374170
Product prescribing error 12.32 9.45 31 123202 35238 64340261
Hypoventilation 12.29 9.45 32 123201 5974 64369525
Vitreous disorder 12.27 9.45 7 123226 243 64375256
Mania 12.25 9.45 8 123225 16278 64359221
Local reaction 12.22 9.45 9 123224 486 64375013
Exophthalmos 12.22 9.45 15 123218 1545 64373954
End-tidal CO2 decreased 12.11 9.45 4 123229 34 64375465
Vitreous floaters 12.08 9.45 33 123200 6340 64369159
Body dysmorphic disorder 12.04 9.45 7 123226 252 64375247
Diplopia 12.02 9.45 90 123143 26675 64348824
Injection site atrophy 11.98 9.45 8 123225 369 64375130
Intraocular pressure increased 11.95 9.45 39 123194 8263 64367236
Rash 11.94 9.45 736 122497 457813 63917686
Heart rate decreased 11.88 9.45 159 123074 54908 64320591
Dermatitis contact 11.82 9.45 41 123192 8959 64366540
Opisthotonus 11.82 9.45 10 123223 661 64374838
Retinal haemorrhage 11.79 9.45 36 123197 7362 64368137
Malignant melanoma 11.77 9.45 5 123228 12959 64362540
Transient ischaemic attack 11.75 9.45 44 123189 44138 64331361
Colour blindness 11.72 9.45 8 123225 383 64375116
Autonomic nervous system imbalance 11.71 9.45 25 123208 4107 64371392
Lung disorder 11.68 9.45 68 123165 60632 64314867
Administration site discolouration 11.65 9.45 3 123230 9 64375490
Infusion site reaction 11.65 9.45 17 123216 2069 64373430
Areflexia 11.64 9.45 28 123205 4979 64370520
Myopathy 11.61 9.45 10 123223 17670 64357829
Madarosis 11.60 9.45 18 123215 2312 64373187
Seizure like phenomena 11.54 9.45 15 123218 1637 64373862
Femoral nerve injury 11.53 9.45 4 123229 40 64375459
Anaphylactoid syndrome of pregnancy 11.53 9.45 4 123229 40 64375459
Symblepharon 11.53 9.45 6 123227 173 64375326
Hypocalcaemia 11.49 9.45 41 123192 41712 64333787
Troponin increased 11.48 9.45 59 123174 15340 64360159
XIIth nerve injury 11.41 9.45 3 123230 10 64375489
Central venous catheter removal 11.39 9.45 8 123225 401 64375098
Serotonin syndrome 11.38 9.45 120 123113 39162 64336337
Injection site pain 11.35 9.45 286 122947 111122 64264377
Myocardial infarction 11.35 9.45 236 122997 165585 64209914
Product contamination 11.29 9.45 12 123221 1057 64374442
Reperfusion arrhythmia 11.26 9.45 7 123226 285 64375214
Myocardial stunning 11.25 9.45 6 123227 182 64375317
Type IV hypersensitivity reaction 11.23 9.45 22 123211 3400 64372099
Pain in jaw 11.23 9.45 40 123193 40715 64334784
Retinal ischaemia 11.21 9.45 10 123223 710 64374789
Injection site oedema 11.19 9.45 12 123221 1068 64374431
Electrocardiogram ST-T segment depression 11.19 9.45 3 123230 11 64375488
Tachypnoea 11.18 9.45 88 123145 26483 64349016
Electrocardiogram P wave abnormal 11.18 9.45 7 123226 289 64375210
Electrocardiogram T wave amplitude decreased 11.17 9.45 9 123224 556 64374943
Nervous system disorder 11.17 9.45 79 123154 22999 64352500
Dermatitis exfoliative 11.12 9.45 3 123230 10349 64365150
Vocal cord dysfunction 11.11 9.45 8 123225 417 64375082
Corneal opacity 11.08 9.45 11 123222 894 64374605
Photosensitivity reaction 11.08 9.45 11 123222 18162 64357337
Poisoning deliberate 10.98 9.45 6 123227 13452 64362047
Suicide attempt 10.94 9.45 85 123148 70922 64304577
Product preparation issue 10.93 9.45 10 123223 734 64374765
Hepatic cirrhosis 10.93 9.45 21 123212 26277 64349222
Lung neoplasm malignant 10.91 9.45 15 123218 21433 64354066
Headache 10.90 9.45 1163 122070 528304 63847195
Product measured potency issue 10.82 9.45 6 123227 197 64375302
Oral herpes 10.82 9.45 76 123157 22076 64353423
Victim of spousal abuse 10.79 9.45 3 123230 13 64375486
Irritable bowel syndrome 10.75 9.45 36 123197 37333 64338166
Myokymia 10.72 9.45 5 123228 113 64375386
Alanine aminotransferase increased 10.69 9.45 194 123039 138837 64236662
Neuropathy peripheral 10.68 9.45 159 123074 117366 64258133
Corneal abrasion 10.65 9.45 11 123222 937 64374562
Hallucination, auditory 10.62 9.45 10 123223 16929 64358570
Oxygen saturation decreased 10.59 9.45 274 122959 106902 64268597
Cardiac procedure complication 10.58 9.45 7 123226 318 64375181
Electrocardiogram U wave present 10.56 9.45 5 123228 117 64375382
Hepatitis cholestatic 10.55 9.45 5 123228 12150 64363349
N-terminal prohormone brain natriuretic peptide 10.52 9.45 4 123229 53 64375446
Treatment noncompliance 10.49 9.45 45 123188 43437 64332062
Product confusion 10.44 9.45 3 123230 15 64375484
Musculoskeletal pain 10.44 9.45 102 123131 81192 64294307
Coccygectomy 10.44 9.45 3 123230 15 64375484
Disseminated intravascular coagulation 10.42 9.45 101 123132 32247 64343252
pH body fluid abnormal 10.41 9.45 5 123228 121 64375378
Fluid retention 10.32 9.45 69 123164 59537 64315962
CSF pressure increased 10.30 9.45 6 123227 217 64375282
Larynx irritation 10.30 9.45 5 123228 124 64375375
Extrasystoles 10.24 9.45 32 123201 6626 64368873
Blister 10.23 9.45 102 123131 80865 64294634
Administration related reaction 10.22 9.45 5 123228 126 64375373
Paranasal cyst 10.22 9.45 7 123226 337 64375162
Genital ulceration 10.15 9.45 9 123224 634 64374865
Injection site nerve damage 10.13 9.45 4 123229 59 64375440
Oesophageal obstruction 10.11 9.45 10 123223 809 64374690
Smoke sensitivity 10.09 9.45 8 123225 483 64375016
Procedural anxiety 10.08 9.45 9 123224 640 64374859
Cholangitis 10.08 9.45 4 123229 10798 64364701
Angina pectoris 10.07 9.45 48 123185 45033 64330466
Tenosynovitis 10.07 9.45 5 123228 11828 64363671
Foot deformity 10.05 9.45 10 123223 16494 64359005
Muscle tightness 10.03 9.45 45 123188 11070 64364429
Polyneuropathy 10.03 9.45 14 123219 19880 64355619
Hypertension 10.01 9.45 598 122635 258663 64116836
Enthesopathy 9.97 9.45 3 123230 9635 64365864
Ocular retrobulbar haemorrhage 9.94 9.45 5 123228 134 64375365
Product formulation issue 9.92 9.45 10 123223 828 64374671
Flushing 9.91 9.45 208 123025 78440 64297059
Incision site pain 9.88 9.45 18 123215 2636 64372863
Blood pressure immeasurable 9.86 9.45 15 123218 1893 64373606
Poor quality sleep 9.84 9.45 66 123167 18885 64356614
Hyperkalaemia 9.83 9.45 135 123098 100994 64274505
Post transplant lymphoproliferative disorder 9.82 9.45 3 123230 9541 64365958
Prescribed underdose 9.78 9.45 12 123221 18003 64357496
Cardiac failure 9.77 9.45 186 123047 132187 64243312
Brain herniation 9.68 9.45 31 123202 6502 64368997
Thinking abnormal 9.65 9.45 5 123228 11551 64363948
Concomitant disease aggravated 9.63 9.45 5 123228 11537 64363962
No reaction on previous exposure to drug 9.62 9.45 6 123227 246 64375253
Allergic reaction to excipient 9.62 9.45 6 123227 246 64375253
Bradyphrenia 9.60 9.45 3 123230 9403 64366096
Repetitive strain injury 9.55 9.45 5 123228 146 64375353
Blood creatine phosphokinase increased 9.54 9.45 69 123164 58489 64317010
Blood pressure fluctuation 9.51 9.45 59 123174 51812 64323687
Orbital infection 9.51 9.45 4 123229 70 64375429
Arrhythmia 9.49 9.45 148 123085 52796 64322703
Fat embolism 9.47 9.45 7 123226 380 64375119
Anaesthetic complication cardiac 9.46 9.45 4 123229 71 64375428

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 32.95 27.39 10 147 67 84454
Cardiac arrest neonatal 30.99 27.39 10 147 84 84437

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
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
Allergic Reactions indication
Administration of Local Anesthetic Nerve Block 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
Occlusive Vascular Disease contraindication
Regional Anesthesia for Labor Pain contraindication
Lidocaine Toxicity contraindication
Pupillary Block Glaucoma contraindication
Reduced Hepatic Blood Flow 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 BELCHER 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 BELCHER 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 BELCHER 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 BELCHER 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 BELCHER 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
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
55-31-2 SECONDARY_CAS_RN
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

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
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
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
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
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 0404-6512 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
Bupivacaine Hydrochloride and Epinephrine HUMAN PRESCRIPTION DRUG LABEL 2 0404-9828 INJECTION, SOLUTION 5 ug INFILTRATION ANDA 12 sections
Epinephrine HUMAN PRESCRIPTION DRUG LABEL 1 0404-9856 INJECTION, SOLUTION 0.10 mg INTRAVENOUS unapproved drug other 11 sections
EPINEPHRINE HUMAN PRESCRIPTION DRUG LABEL 1 0404-9857 INJECTION, SOLUTION, CONCENTRATE 1 mg INTRAVENOUS NDA 16 sections
EPINEPHRINE HUMAN PRESCRIPTION DRUG LABEL 1 0404-9857 INJECTION, SOLUTION, CONCENTRATE 1 mg INTRAVENOUS NDA 16 sections
Lidocaine Hydrochloride and Epinephrine HUMAN PRESCRIPTION DRUG LABEL 2 0404-9886 INJECTION, SOLUTION 5 ug INFILTRATION ANDA 10 sections
Lidocaine Hydrochloride and Epinephrine HUMAN PRESCRIPTION DRUG LABEL 2 0404-9891 INJECTION, SOLUTION 10 ug INFILTRATION ANDA 10 sections
Lidocaine Hydrochloride and Epinephrine HUMAN PRESCRIPTION DRUG LABEL 2 0404-9896 INJECTION, SOLUTION 10 ug INFILTRATION ANDA 10 sections