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

Stem definitionDrug idCAS RN
597 55-56-1

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • chlorhexidine hydrochloride
  • chlorhexidine
  • chlorohex
  • chlorohexidine
  • chlorhexidine gluconate
  • chlorhexidine acetate
A disinfectant and topical anti-infective agent used also as mouthwash to prevent oral plaque.
  • Molecular weight: 505.45
  • Formula: C22H30Cl2N10
  • CLOGP: 4.81
  • LIPINSKI: 2
  • HAC: 10
  • HDO: 10
  • TPSA: 167.58
  • ALOGS: -4.29
  • ROTB: 9
  • Status: OFP
    • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
30 mg O
30 mg O

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 4 Bocci G, Oprea TI, Benet LZ
BA (Bioavailability) 1 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
S (Water solubility) 0.03 mg/mL Bocci G, Oprea TI, Benet LZ

Approvals:

DateAgencyCompanyOrphan
Sept. 17, 1976 FDA MOLNLYCKE HLTH

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
Completed suicide 2783.95 16.25 2249 116686 143424 63226663
Folliculitis 2337.40 16.25 1520 117415 68797 63301290
Muscle injury 2303.97 16.25 1466 117469 63879 63306208
Irritable bowel syndrome 2153.10 16.25 1535 117400 80877 63289210
Lower respiratory tract infection 2036.91 16.25 1805 117130 130502 63239585
Impaired healing 1815.33 16.25 1516 117419 101026 63269061
Sleep disorder due to general medical condition, insomnia type 1678.59 16.25 1106 117829 51111 63318976
Blister 1593.72 16.25 1562 117373 128252 63241835
Stomatitis 1424.21 16.25 1516 117419 137209 63232878
Ill-defined disorder 1421.95 16.25 1197 117738 80558 63289529
Gastrointestinal disorder 1357.32 16.25 1440 117495 129799 63240288
Toxicity to various agents 1149.90 16.25 1826 117109 245424 63124663
Sinusitis 1020.66 16.25 1650 117285 225003 63145084
Duodenal ulcer perforation 1016.48 16.25 1021 117914 86188 63283899
Helicobacter infection 1004.72 16.25 1044 117891 91741 63278346
Peripheral swelling 927.02 16.25 1729 117206 264213 63105874
Confusional state 888.37 16.25 1588 117347 234792 63135295
Therapeutic product effect decreased 883.71 16.25 1417 117518 191770 63178317
Drug abuse 806.45 16.25 828 118107 71690 63298397
Nasopharyngitis 793.66 16.25 1578 117357 252679 63117408
Infection 776.94 16.25 1473 117462 227700 63142387
Pruritus 738.61 16.25 1895 117040 359558 63010529
Pericarditis 716.54 16.25 1047 117888 130532 63239555
Joint swelling 686.92 16.25 1735 117200 325931 63044156
Swelling 669.00 16.25 1544 117391 273834 63096253
Weight increased 667.66 16.25 1493 117442 259299 63110788
Hypersensitivity 664.34 16.25 1598 117337 291087 63079000
Anti-cyclic citrullinated peptide antibody positive 638.80 16.25 929 118006 115283 63254804
Contusion 572.91 16.25 1016 117919 149028 63221059
Discomfort 522.77 16.25 1040 117895 166334 63203753
Hand deformity 484.98 16.25 980 117955 158477 63211610
Nausea 465.68 16.25 552 118383 853919 62516168
Cardio-respiratory arrest 438.42 16.25 551 118384 59408 63310679
Hepatic enzyme increased 437.26 16.25 1085 117850 201243 63168844
Synovitis 436.67 16.25 1033 117902 185885 63184202
Wound 433.18 16.25 949 117986 162314 63207773
Muscle spasticity 419.75 16.25 339 118596 21455 63348632
Night sweats 417.95 16.25 486 118449 48328 63321759
Glossodynia 417.20 16.25 988 117947 177888 63192199
Pemphigus 411.52 16.25 999 117936 182727 63187360
Fall 408.28 16.25 115 118820 392219 62977868
Ear pain 407.70 16.25 416 118519 35702 63334385
Systemic lupus erythematosus 349.14 16.25 1019 117916 207899 63162188
Body temperature increased 344.94 16.25 386 118549 36806 63333281
Contraindicated product administered 344.20 16.25 1041 117894 216607 63153480
Arthropathy 339.00 16.25 1088 117847 233704 63136383
Intentional overdose 328.69 16.25 537 118398 73615 63296472
Respiratory disorder 303.03 16.25 370 118565 38712 63331375
Cough 298.46 16.25 89 118846 292654 63077433
Alcohol interaction 291.43 16.25 124 118811 2285 63367802
Rash 288.39 16.25 1915 117020 558956 62811131
Product dose omission issue 287.58 16.25 47 118888 234266 63135821
Anaemia 260.32 16.25 112 118823 293318 63076769
Infusion related reaction 254.46 16.25 1021 117914 244500 63125587
Malaise 251.95 16.25 245 118690 415709 62954378
Pyrexia 241.86 16.25 1607 117328 468871 62901216
Pneumonia 239.40 16.25 303 118632 456464 62913623
Pain in extremity 236.85 16.25 166 118769 331320 63038767
Suspected suicide 215.25 16.25 141 118794 6427 63363660
Urinary tract infection 201.95 16.25 123 118812 264561 63105526
Dehydration 193.13 16.25 44 118891 173310 63196777
Dizziness 192.88 16.25 318 118617 429607 62940480
Acute kidney injury 186.63 16.25 133 118802 263282 63106805
Suicide attempt 179.61 16.25 370 118565 60548 63309539
Sleep disorder 173.24 16.25 435 118500 81131 63288956
Urticaria 169.56 16.25 687 118248 165115 63204972
Injection site pain 168.50 16.25 22 118913 129778 63240309
Rheumatoid arthritis 162.89 16.25 919 118016 252900 63117187
Constipation 160.06 16.25 113 118822 224830 63145257
Abdominal discomfort 159.04 16.25 1087 117848 319798 63050289
Deep vein thrombosis postoperative 158.34 16.25 147 118788 11222 63358865
Blood pressure increased 156.61 16.25 54 118881 162008 63208079
Overdose 152.95 16.25 519 118416 114559 63255528
Haemoglobin decreased 152.22 16.25 42 118893 145443 63224644
Off label use 147.31 16.25 707 118228 673755 62696332
Alcohol poisoning 144.42 16.25 71 118864 1848 63368239
Feeling abnormal 144.15 16.25 49 118886 148343 63221744
Alopecia 143.41 16.25 1102 117833 336434 63033653
Weight decreased 142.30 16.25 186 118749 276612 63093475
Drug intolerance 140.30 16.25 1024 117911 307637 63062450
COVID-19 135.76 16.25 24 118911 113079 63257008
Bronchitis 128.96 16.25 37 118898 124898 63245189
Lip dry 128.95 16.25 152 118783 15318 63354769
Myocardial infarction 127.11 16.25 18 118917 99875 63270212
Cerebrovascular accident 125.22 16.25 25 118910 107999 63262088
Exposure to toxic agent 125.04 16.25 95 118840 5492 63364595
Facet joint syndrome 124.71 16.25 133 118802 12005 63358082
Influenza 124.29 16.25 26 118909 108696 63261391
Therapeutic product effect incomplete 123.73 16.25 40 118895 125016 63245071
Myalgia 123.45 16.25 60 118875 146469 63223618
Diarrhoea 122.98 16.25 811 118124 714555 62655532
Neutropenia 120.44 16.25 91 118844 174914 63195173
Cardiac failure congestive 119.15 16.25 16 118919 92417 63277670
White blood cell count decreased 118.66 16.25 56 118879 139048 63231039
Chills 118.09 16.25 33 118902 113345 63256742
Thrombocytopenia 116.94 16.25 69 118866 151088 63218999
Hyponatraemia 115.75 16.25 33 118902 111867 63258220
Medication error 115.37 16.25 283 118652 52001 63318086
Insomnia 114.83 16.25 743 118192 214509 63155578
Autoimmune disorder 114.68 16.25 151 118784 17026 63353061
Syncope 113.58 16.25 39 118896 117346 63252741
Alcohol use 113.50 16.25 62 118873 2017 63368070
Inappropriate schedule of product administration 112.57 16.25 28 118907 103937 63266150
Platelet count decreased 111.64 16.25 39 118896 116083 63254004
Renal failure 108.91 16.25 42 118893 117610 63252477
Arthralgia 104.72 16.25 1571 117364 568139 62801948
Peripheral venous disease 103.24 16.25 136 118799 15341 63354746
Arthritis 99.89 16.25 46 118889 115875 63254212
Injection site erythema 99.04 16.25 18 118917 83156 63286931
Maternal exposure timing unspecified 97.47 16.25 91 118844 6996 63363091
Psoriasis 96.94 16.25 22 118913 86935 63283152
Balance disorder 96.87 16.25 20 118915 84402 63285685
Erythema 96.67 16.25 112 118823 175639 63194448
Pulmonary embolism 96.43 16.25 49 118886 116635 63253452
Respiratory arrest 94.68 16.25 197 118738 32448 63337639
Hyperhidrosis 94.15 16.25 42 118893 107794 63262293
Maternal exposure during pregnancy 93.58 16.25 719 118216 219343 63150744
Blood glucose increased 91.76 16.25 22 118913 83734 63286353
Alcohol abuse 90.31 16.25 54 118881 2092 63367995
Hypotension 89.76 16.25 240 118695 272364 63097723
Renal impairment 89.64 16.25 27 118908 88328 63281759
Gastrointestinal haemorrhage 89.57 16.25 21 118914 81155 63288932
Interstitial lung disease 89.37 16.25 7 118928 61901 63308186
Gastrooesophageal reflux disease 88.75 16.25 34 118901 95605 63274482
Pancytopenia 87.42 16.25 36 118899 96897 63273190
Headache 87.31 16.25 763 118172 632478 62737609
Upper respiratory tract infection 87.08 16.25 23 118912 82024 63288063
Oropharyngeal pain 87.00 16.25 34 118901 94453 63275634
Chest discomfort 86.74 16.25 49 118886 109920 63260167
Tremor 85.66 16.25 73 118862 132166 63237921
Condition aggravated 85.00 16.25 426 118509 401791 62968296
Heart rate increased 84.99 16.25 35 118900 94203 63275884
Vision blurred 84.76 16.25 33 118902 91891 63278196
Gait disturbance 83.33 16.25 134 118801 183044 63187043
Drug interaction 83.01 16.25 192 118743 228939 63141148
Productive cough 81.32 16.25 11 118924 63197 63306890
Leukopenia 79.54 16.25 23 118912 77267 63292820
Fluid retention 77.71 16.25 10 118925 59676 63310411
Diabetes mellitus 76.03 16.25 8 118927 55802 63314285
Atrial fibrillation 76.01 16.25 64 118871 116572 63253515
Palpitations 75.83 16.25 60 118875 112710 63257377
Decreased appetite 73.89 16.25 233 118702 250819 63119268
Herpes zoster 73.75 16.25 31 118904 82431 63287656
Abdominal pain 73.27 16.25 292 118643 293164 63076923
Visual impairment 70.46 16.25 35 118900 84411 63285676
Drug hypersensitivity 69.69 16.25 322 118613 310365 63059722
Liver injury 69.26 16.25 260 118675 60260 63309827
Incorrect dose administered 69.23 16.25 14 118921 59954 63310133
Malignant neoplasm progression 68.58 16.25 34 118901 82087 63288000
Road traffic accident 68.15 16.25 186 118749 36446 63333641
Cardiac disorder 67.42 16.25 8 118927 50808 63319279
Influenza like illness 66.74 16.25 21 118914 66803 63303284
Deep vein thrombosis 66.57 16.25 37 118898 83763 63286324
Multiple sclerosis relapse 65.90 16.25 7 118928 48471 63321616
Neck pain 65.38 16.25 24 118911 69294 63300793
Intentional product misuse 65.04 16.25 256 118679 60661 63309426
Blood pressure fluctuation 64.77 16.25 6 118929 46311 63323776
Disease progression 63.50 16.25 82 118853 122676 63247411
Angioedema 62.53 16.25 8 118927 47957 63322130
Stress 62.11 16.25 24 118911 67143 63302944
Hyperkalaemia 61.85 16.25 13 118922 54190 63315897
Wrong technique in product usage process 61.53 16.25 20 118915 62320 63307767
Nasal congestion 61.48 16.25 23 118912 65637 63304450
Dysphagia 60.99 16.25 46 118889 88539 63281548
Incorrect route of product administration 60.97 16.25 149 118786 27303 63342784
Haematochezia 60.77 16.25 13 118922 53531 63316556
Sepsis 60.66 16.25 122 118813 153001 63217086
Chronic obstructive pulmonary disease 60.32 16.25 21 118914 62665 63307422
Abdominal distension 59.60 16.25 45 118890 86570 63283517
Rheumatic fever 59.49 16.25 197 118738 42914 63327173
Respiratory failure 59.18 16.25 62 118873 101796 63268291
Cystitis 59.15 16.25 15 118920 54976 63315111
No adverse event 58.88 16.25 5 118930 41400 63328687
Cognitive disorder 58.56 16.25 16 118919 55799 63314288
Thrombosis 58.46 16.25 24 118911 64731 63305356
C-reactive protein 58.29 16.25 58 118877 4824 63365263
Cataract 56.85 16.25 18 118917 57035 63313052
Cardiac failure 56.75 16.25 50 118885 89092 63280995
Intentional product use issue 56.05 16.25 421 118514 127471 63242616
Cellulitis 55.86 16.25 43 118892 81915 63288172
Bradycardia 55.80 16.25 34 118901 73193 63296894
Diverticulitis 55.64 16.25 5 118930 39552 63330535
Pain 55.44 16.25 1795 117140 738833 62631254
Swollen joint count increased 55.43 16.25 171 118764 35883 63334204
Prescribed overdose 55.34 16.25 165 118770 33988 63336099
Injection site swelling 55.13 16.25 11 118924 47561 63322526
Dyspnoea 55.11 16.25 1624 117311 659689 62710398
Septic shock 55.01 16.25 28 118907 66601 63303486
Rhinorrhoea 54.98 16.25 27 118908 65550 63304537
Abdominal pain upper 54.02 16.25 608 118327 205836 63164251
Chronic kidney disease 53.66 16.25 10 118925 45388 63324699
Injury 53.48 16.25 275 118660 72972 63297115
Depression 53.24 16.25 189 118746 196303 63173784
Burning sensation 52.74 16.25 18 118917 54389 63315698
Abortion spontaneous 52.47 16.25 12 118923 47183 63322904
Injection site reaction 52.33 16.25 22 118913 58502 63311585
Throat irritation 52.31 16.25 5 118930 37642 63332445
Dyspnoea exertional 51.82 16.25 24 118911 60278 63309809
Neutrophil count decreased 50.77 16.25 21 118914 56385 63313702
Pleural effusion 50.57 16.25 60 118875 93150 63276937
Blood creatinine increased 50.44 16.25 54 118881 87790 63282297
Oedema peripheral 49.55 16.25 185 118750 189326 63180761
Adjustment disorder with depressed mood 49.42 16.25 77 118858 10127 63359960
Oxygen saturation decreased 49.17 16.25 56 118879 88529 63281558
Lower limb fracture 49.12 16.25 127 118808 24094 63345993
Injection site pruritus 49.11 16.25 12 118923 45104 63324983
Postmortem blood drug level abnormal 48.58 16.25 20 118915 338 63369749
Fungal infection 48.43 16.25 6 118929 36868 63333219
Vertigo 48.21 16.25 26 118909 59861 63310226
Bone pain 48.12 16.25 21 118914 54620 63315467
Full blood count abnormal 47.47 16.25 3 118932 31714 63338373
Rheumatoid factor positive 47.17 16.25 295 118640 84111 63285976
Pregnancy 47.02 16.25 164 118771 36672 63333415
Pancreatitis 46.23 16.25 17 118918 49038 63321049
Blood alcohol increased 45.74 16.25 23 118912 629 63369458
Femur fracture 45.66 16.25 11 118924 41745 63328342
International normalised ratio increased 45.63 16.25 15 118920 46410 63323677
Joint range of motion decreased 45.47 16.25 149 118786 32279 63337808
Osteoporosis 44.56 16.25 26 118909 57312 63312775
Renal disorder 44.21 16.25 5 118930 32969 63337118
Febrile neutropenia 43.87 16.25 98 118837 118351 63251736
Cholestasis 43.42 16.25 3 118932 29431 63340656
Unevaluable event 43.31 16.25 21 118914 51365 63318722
Blood pressure decreased 43.19 16.25 35 118900 64987 63305100
Alcoholism 43.10 16.25 32 118903 1786 63368301
Orthostatic hypotension 42.66 16.25 8 118927 36152 63333935
Flatulence 42.42 16.25 7 118928 34695 63335392
Dysphonia 42.41 16.25 18 118917 47596 63322491
Skin exfoliation 42.23 16.25 14 118921 43088 63326999
Blood pressure systolic increased 42.08 16.25 18 118917 47379 63322708
Haematocrit decreased 41.79 16.25 11 118924 39329 63330758
Haemorrhage 41.60 16.25 32 118903 60990 63309097
Obesity 41.43 16.25 137 118798 29815 63340272
Drug ineffective for unapproved indication 41.35 16.25 7 118928 34056 63336031
Rash pruritic 41.22 16.25 31 118904 59768 63310319
Transient ischaemic attack 41.18 16.25 10 118925 37743 63332344
Swelling face 41.13 16.25 35 118900 63440 63306647
Loss of personal independence in daily activities 40.71 16.25 75 118860 97215 63272872
Intestinal obstruction 40.65 16.25 5 118930 30894 63339193
Anxiety 40.57 16.25 240 118695 217301 63152786
Haematoma 40.46 16.25 8 118927 34812 63335275
Hypertension 40.36 16.25 332 118603 278971 63091116
Feeling hot 40.33 16.25 22 118913 50332 63319755
Red blood cell count decreased 40.18 16.25 13 118922 40632 63329455
Illness 39.92 16.25 21 118914 49038 63321049
Chemical submission 39.10 16.25 16 118919 266 63369821
Victim of sexual abuse 39.01 16.25 21 118914 663 63369424
Therapeutic response decreased 38.57 16.25 35 118900 61490 63308597
Gastroenteritis 38.39 16.25 3 118932 26587 63343500
Alanine aminotransferase increased 38.31 16.25 86 118849 103684 63266403
Adverse event 38.29 16.25 237 118698 67322 63302765
Hypothyroidism 38.16 16.25 16 118919 42616 63327471
Basal cell carcinoma 38.15 16.25 4 118931 27987 63342100
Rash maculo-papular 37.75 16.25 7 118928 31889 63338198
Breast cancer 37.51 16.25 22 118913 48361 63321726
Therapy interrupted 36.59 16.25 8 118927 32447 63337640
Swollen tongue 36.46 16.25 10 118925 34790 63335297
Dyskinesia 35.85 16.25 8 118927 31994 63338093
Disease recurrence 35.76 16.25 5 118930 28025 63342062
Muscular weakness 35.64 16.25 114 118821 122239 63247848
Red blood cell sedimentation rate increased 35.54 16.25 19 118916 43963 63326124
Migraine 35.48 16.25 89 118846 103257 63266830
Vaginal haemorrhage 34.84 16.25 5 118930 27482 63342605
Substance abuse 34.81 16.25 44 118891 4763 63365324
Full blood count decreased 34.76 16.25 4 118931 26020 63344067
Plasma cell myeloma 34.59 16.25 12 118923 35893 63334194
Hypoaesthesia 34.54 16.25 180 118755 168213 63201874
Macular degeneration 34.50 16.25 3 118932 24373 63345714
Coronary artery disease 34.49 16.25 9 118926 32368 63337719
Liver function test abnormal 34.49 16.25 24 118911 48157 63321930
Bursitis 34.28 16.25 149 118786 36892 63333195
Abdominal pain lower 34.16 16.25 4 118931 25674 63344413
C-reactive protein abnormal 33.59 16.25 173 118762 45923 63324164
Toxic epidermal necrolysis 33.57 16.25 4 118931 25330 63344757
Therapy cessation 33.35 16.25 8 118927 30449 63339638
Sleep apnoea syndrome 33.21 16.25 7 118928 29126 63340961
Hepatic function abnormal 33.14 16.25 14 118921 37128 63332959
Urinary retention 33.10 16.25 8 118927 30293 63339794
Lymphocyte count decreased 33.03 16.25 8 118927 30249 63339838
Product quality issue 32.85 16.25 13 118922 35852 63334235
Drug eruption 32.49 16.25 7 118928 28687 63341400
Clostridium difficile infection 32.49 16.25 8 118927 29914 63340173
Oral herpes 32.46 16.25 5 118930 26069 63344018
Chest pain 32.43 16.25 254 118681 215705 63154382
Neoplasm malignant 32.39 16.25 8 118927 29853 63340234
Aspartate aminotransferase increased 32.37 16.25 76 118859 90201 63279886
Dry eye 32.36 16.25 18 118917 40743 63329344
Urticaria thermal 32.31 16.25 16 118919 423 63369664
Ascites 32.31 16.25 18 118917 40710 63329377
X-ray abnormal 32.25 16.25 56 118879 8054 63362033
Joint injury 31.93 16.25 8 118927 29564 63340523
Hospitalisation 31.82 16.25 70 118865 85011 63285076
Pallor 31.62 16.25 9 118926 30559 63339528
Haematemesis 31.37 16.25 9 118926 30403 63339684
Nephrolithiasis 31.28 16.25 20 118915 41964 63328123
Eye swelling 31.15 16.25 4 118931 23914 63346173
Tinnitus 30.89 16.25 14 118921 35614 63334473
Diplopia 30.83 16.25 4 118931 23724 63346363
C-reactive protein increased 30.65 16.25 84 118851 94623 63275464
Respiratory tract infection 30.58 16.25 20 118915 41463 63328624
Stevens-Johnson syndrome 30.57 16.25 5 118930 24945 63345142
Lymphadenopathy 30.51 16.25 17 118918 38441 63331646
Dry skin 30.45 16.25 37 118898 56850 63313237
Flushing 30.43 16.25 59 118876 75028 63295059
Ulcer 30.33 16.25 6 118929 26101 63343986
Limb discomfort 30.28 16.25 9 118926 29707 63340380
Aphasia 30.16 16.25 12 118923 32988 63337099
Cardiac arrest 30.09 16.25 285 118650 92260 63277827
Cerebral haemorrhage 30.07 16.25 10 118925 30719 63339368
Sinus disorder 29.91 16.25 5 118930 24548 63345539
Multiple sclerosis 29.61 16.25 5 118930 24367 63345720
Melaena 29.51 16.25 10 118925 30355 63339732
Viral infection 29.41 16.25 15 118920 35648 63334439
Angina pectoris 29.07 16.25 10 118925 30068 63340019
Neoplasm progression 29.05 16.25 16 118919 36412 63333675
Dysstasia 28.91 16.25 3 118932 21163 63348924
Gastritis 28.86 16.25 17 118918 37286 63332801
Cerebral infarction 28.81 16.25 5 118930 23888 63346199
Skin ulcer 28.80 16.25 23 118912 43022 63327065
Cholelithiasis 28.73 16.25 24 118911 43901 63326186
Dislocation of vertebra 28.49 16.25 55 118880 8580 63361507
Blood cholesterol increased 28.33 16.25 285 118650 93747 63276340
Hip arthroplasty 28.17 16.25 169 118766 47477 63322610
Rash erythematous 28.08 16.25 23 118912 42487 63327600
Acne 27.81 16.25 5 118930 23288 63346799
Jaundice 27.79 16.25 10 118925 29241 63340846
Burkholderia test positive 27.62 16.25 12 118923 233 63369854
Kidney infection 27.62 16.25 5 118930 23171 63346916
Gastric disorder 27.57 16.25 18 118917 37351 63332736
Blindness 27.38 16.25 4 118931 21695 63348392
Anti-cyclic citrullinated peptide antibody 27.32 16.25 47 118888 6711 63363376
Hyperglycaemia 27.23 16.25 23 118912 41844 63328243
Pulmonary hypertension 27.23 16.25 18 118917 37105 63332982
Drug resistance 27.21 16.25 5 118930 22928 63347159
Neuropathy peripheral 27.13 16.25 115 118820 113552 63256535
Hypoacusis 27.13 16.25 6 118929 24145 63345942
Haemoptysis 26.99 16.25 10 118925 28716 63341371
Gastric ulcer 26.94 16.25 6 118929 24031 63346056
Blood urea increased 26.86 16.25 8 118927 26371 63343716
Product prescribing error 26.72 16.25 8 118927 26281 63343806
Muscle spasms 26.65 16.25 177 118758 155973 63214114
Hepatocellular injury 26.64 16.25 9 118926 27372 63342715
White blood cell count increased 26.61 16.25 31 118904 48530 63321557
Device issue 26.53 16.25 6 118929 23775 63346312
Myelosuppression 26.40 16.25 6 118929 23697 63346390
Throat tightness 26.36 16.25 7 118928 24880 63345207
Joint stiffness 26.03 16.25 24 118911 41845 63328242
Localised infection 25.99 16.25 12 118923 30198 63339889
Pollakiuria 25.79 16.25 10 118925 27927 63342160
Hemiparesis 25.72 16.25 6 118929 23276 63346811
Speech disorder 25.60 16.25 23 118912 40606 63329481
Limb injury 25.45 16.25 8 118927 25469 63344618
Hypoglycaemia 25.39 16.25 46 118889 60019 63310068
Diabetic ketoacidosis 25.37 16.25 4 118931 20501 63349586
Movement disorder 25.11 16.25 5 118930 21656 63348431
Blood potassium decreased 25.06 16.25 25 118910 42001 63328086
Body temperature decreased 25.06 16.25 4 118931 20315 63349772
Hip fracture 24.91 16.25 12 118923 29462 63340625
Gallbladder disorder 24.91 16.25 3 118932 18839 63351248
Injection site rash 24.85 16.25 3 118932 18806 63351281
Eye disorder 24.76 16.25 6 118929 22679 63347408
Bone marrow failure 24.64 16.25 12 118923 29278 63340809
Pancreatitis acute 24.63 16.25 10 118925 27156 63342931
Hot flush 24.60 16.25 36 118899 51123 63318964
Pulmonary arterial hypertension 24.58 16.25 6 118929 22571 63347516
Mydriasis 24.56 16.25 63 118872 11893 63358194
Dysgeusia 24.35 16.25 31 118904 46679 63323408
Faeces discoloured 24.34 16.25 3 118932 18506 63351581
Surgery 24.26 16.25 19 118916 35893 63334194
Mouth ulceration 24.18 16.25 16 118919 32968 63337119
Rectal haemorrhage 24.07 16.25 34 118901 48996 63321091
Poisoning deliberate 23.97 16.25 60 118875 11158 63358929
Lung neoplasm malignant 23.91 16.25 4 118931 19629 63350458
Fracture 23.83 16.25 4 118931 19580 63350507
Conjunctivitis 23.70 16.25 5 118930 20791 63349296
Ear infection 23.64 16.25 22 118913 38191 63331896
Blood calcium decreased 23.55 16.25 10 118925 26441 63343646
Blood sodium decreased 23.54 16.25 8 118927 24244 63345843
Obstructive airways disorder 23.54 16.25 5 118930 20694 63349393
Frequent bowel movements 23.41 16.25 7 118928 23015 63347072
Palmar-plantar erythrodysaesthesia syndrome 23.39 16.25 7 118928 23008 63347079
Adrenal insufficiency 23.32 16.25 3 118932 17912 63352175
Death 23.28 16.25 529 118406 373852 62996235
Paraesthesia oral 23.28 16.25 4 118931 19252 63350835
Proteinuria 23.10 16.25 4 118931 19141 63350946
Oral candidiasis 23.05 16.25 7 118928 22791 63347296
Procedural pain 22.97 16.25 6 118929 21563 63348524
Haematuria 22.97 16.25 13 118922 29144 63340943
Substance use disorder 22.89 16.25 10 118925 197 63369890
Upper gastrointestinal haemorrhage 22.61 16.25 4 118931 18848 63351239
Dementia 22.51 16.25 4 118931 18790 63351297
Angiokeratoma 22.48 16.25 9 118926 141 63369946
Application site necrosis 22.48 16.25 5 118930 6 63370081
Hypocalcaemia 22.43 16.25 16 118919 31697 63338390
Epistaxis 22.43 16.25 66 118869 72659 63297428
Exposure during pregnancy 22.39 16.25 185 118750 155362 63214725
Colitis 21.57 16.25 36 118899 48492 63321595
Chromaturia 21.28 16.25 3 118932 16714 63353373
Blood pressure diastolic decreased 21.17 16.25 8 118927 22698 63347389
Musculoskeletal discomfort 21.14 16.25 4 118931 17963 63352124
Burkholderia infection 21.13 16.25 4 118931 0 63370087
Sedation 21.02 16.25 25 118910 38784 63331303
Metastases to liver 20.95 16.25 9 118926 23630 63346457
Protein C increased 20.87 16.25 8 118927 111 63369976
Heavy menstrual bleeding 20.82 16.25 4 118931 17769 63352318
Pharyngitis 20.71 16.25 6 118929 20137 63349950
Iron deficiency anaemia 20.43 16.25 6 118929 19963 63350124
Impaired work ability 20.33 16.25 4 118931 17471 63352616
Urinary incontinence 20.32 16.25 18 118917 31996 63338091
Nervousness 20.17 16.25 17 118918 30962 63339125
Posterior reversible encephalopathy syndrome 20.12 16.25 4 118931 17341 63352746
Product substitution issue 20.06 16.25 3 118932 15993 63354094
Gait inability 19.72 16.25 168 118767 52791 63317296
Post procedural complication 19.67 16.25 4 118931 17070 63353017
Eosinophilia 19.64 16.25 9 118926 22747 63347340
Vasculitis 19.51 16.25 5 118930 18204 63351883
Gastroenteritis viral 19.50 16.25 10 118925 23690 63346397
Device dislocation 19.49 16.25 12 118923 25693 63344394
Sinus congestion 19.38 16.25 5 118930 18118 63351969
Disturbance in attention 19.23 16.25 26 118909 38163 63331924
Eye pain 19.22 16.25 21 118914 33833 63336254
Head injury 19.14 16.25 14 118921 27382 63342705
Therapy non-responder 19.12 16.25 222 118713 75679 63294408
Hypercalcaemia 19.11 16.25 15 118920 28307 63341780
Hallucination 18.97 16.25 47 118888 54770 63315317
Victim of chemical submission 18.86 16.25 12 118923 520 63369567
Glaucoma 18.77 16.25 6 118929 18899 63351188
Pneumonitis 18.75 16.25 23 118912 35199 63334888
Platelet count increased 18.72 16.25 5 118930 17706 63352381
Lethargy 18.63 16.25 49 118886 55958 63314129
Multiple organ dysfunction syndrome 18.61 16.25 50 118885 56702 63313385
Burkholderia cepacia complex infection 18.57 16.25 8 118927 152 63369935
Therapeutic response unexpected 18.54 16.25 6 118929 18753 63351334
Blood glucose decreased 18.53 16.25 8 118927 20944 63349143
Blood urine present 18.51 16.25 3 118932 15066 63355021
Eye irritation 18.48 16.25 9 118926 21962 63348125
Mental disorder 18.43 16.25 13 118922 25906 63344181
Memory impairment 18.38 16.25 117 118818 104141 63265946
Product storage error 18.32 16.25 3 118932 14953 63355134
Heart rate decreased 18.28 16.25 36 118899 45524 63324563
Skin disorder 18.24 16.25 17 118918 29490 63340597
Psychotic disorder 18.15 16.25 13 118922 25699 63344388
Skin reaction 18.14 16.25 3 118932 14846 63355241
Fibromyalgia 17.99 16.25 230 118705 80190 63289897
Dysuria 17.99 16.25 22 118913 33716 63336371
Bacterial infection 17.97 16.25 7 118928 19492 63350595
Rib fracture 17.91 16.25 10 118925 22587 63347500
Caesarean section 17.64 16.25 5 118930 17027 63353060
Cardiac murmur 17.64 16.25 3 118932 14549 63355538
Rash macular 17.58 16.25 11 118924 23353 63346734
Complication associated with device 17.56 16.25 5 118930 16973 63353114
Panic attack 17.53 16.25 10 118925 22321 63347766
Palmar erythema 17.51 16.25 19 118916 1748 63368339
Poisoning 17.48 16.25 61 118874 13639 63356448
Rash papular 17.44 16.25 4 118931 15698 63354389
Laboratory test abnormal 17.24 16.25 15 118920 26897 63343190
Mucosal inflammation 17.22 16.25 39 118896 46889 63323198
Myelodysplastic syndrome 17.20 16.25 5 118930 16749 63353338
Ankle fracture 17.14 16.25 6 118929 17849 63352238
Homicide 17.02 16.25 10 118925 375 63369712
Foot fracture 17.00 16.25 12 118923 23902 63346185
Hepatic cytolysis 16.96 16.25 4 118931 15403 63354684
Cyst 16.89 16.25 3 118932 14096 63355991
Breast cancer stage II 16.89 16.25 45 118890 8691 63361396
Disorientation 16.87 16.25 30 118905 39422 63330665
Neutrophil count increased 16.85 16.25 5 118930 16522 63353565
Lip swelling 16.84 16.25 20 118915 31043 63339044
Drug use disorder 16.76 16.25 32 118903 4952 63365135
Substance dependence 16.71 16.25 8 118927 196 63369891
Premature baby 16.69 16.25 9 118926 20726 63349361
Skin necrosis 16.64 16.25 3 118932 13947 63356140
Rhabdomyolysis 16.56 16.25 36 118899 43915 63326172
Restless legs syndrome 16.51 16.25 7 118928 18524 63351563
Oesophagitis 16.32 16.25 4 118931 15004 63355083

FDA Adverse Event Reporting System (Male)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Drug abuse 4907.74 13.43 2189 30303 96907 34827532
Completed suicide 3475.66 13.43 1724 30768 96444 34827995
Toxicity to various agents 3056.67 13.43 2029 30463 198333 34726106
Cardio-respiratory arrest 722.15 13.43 513 31979 54760 34869679
Intentional overdose 658.84 13.43 443 32049 43231 34881208
Alcohol abuse 509.50 13.43 184 32308 4506 34919933
Overdose 488.00 13.43 507 31985 90552 34833887
Alcohol interaction 475.41 13.43 155 32337 2758 34921681
Intentional product misuse 447.59 13.43 357 32135 45254 34879185
Suicide attempt 389.75 13.43 309 32183 38807 34885632
Suspected suicide 348.68 13.43 140 32352 4608 34919831
Alcohol poisoning 299.07 13.43 116 32376 3477 34920962
Drug dependence 295.54 13.43 216 32276 24001 34900438
Substance abuse 252.36 13.43 129 32363 7512 34916927
Exposure to toxic agent 191.73 13.43 85 32407 3590 34920849
Coma 189.85 13.43 223 32269 45455 34878984
Asphyxia 184.88 13.43 101 32391 6734 34917705
Respiratory depression 171.68 13.43 133 32359 16112 34908327
Drug ineffective 158.22 13.43 117 32375 456634 34467805
Aggression 154.90 13.43 186 32306 38778 34885661
Alcohol use 152.32 13.43 70 32422 3218 34921221
Poisoning deliberate 151.18 13.43 93 32399 7751 34916688
Respiratory arrest 149.45 13.43 156 32336 27887 34896552
Burkholderia test positive 137.31 13.43 47 32445 976 34923463
Cardiac arrest 110.69 13.43 263 32229 95896 34828543
Burkholderia infection 104.32 13.43 23 32469 75 34924364
Blood alcohol increased 103.44 13.43 36 32456 787 34923652
Recalled product administered 101.42 13.43 32 32460 509 34923930
Product contamination microbial 95.17 13.43 32 32460 628 34923811
Off label use 94.67 13.43 153 32339 419371 34505068
Incorrect route of product administration 94.55 13.43 91 32401 14754 34909685
Substance use disorder 93.78 13.43 33 32459 746 34923693
Poisoning 93.48 13.43 83 32409 12143 34912296
Intentional product use issue 82.63 13.43 176 32316 59640 34864799
Drug use disorder 73.97 13.43 47 32445 4144 34920295
Fatigue 72.07 13.43 148 32344 370505 34553934
Death 71.57 13.43 621 31871 397428 34527011
Prescription drug used without a prescription 70.04 13.43 36 32456 2118 34922321
Burkholderia cepacia complex infection 69.78 13.43 19 32473 174 34924265
Miosis 69.47 13.43 63 32429 9472 34914967
Anaphylactic reaction 68.23 13.43 114 32378 32187 34892252
Diarrhoea 68.19 13.43 165 32327 389747 34534692
Tachycardia 66.25 13.43 201 32291 84571 34839868
Suicidal ideation 61.82 13.43 124 32368 40264 34884175
Intentional self-injury 61.78 13.43 70 32422 13701 34910738
Drug withdrawal syndrome 60.38 13.43 83 32409 19751 34904688
Depressed level of consciousness 60.23 13.43 127 32365 42714 34881725
Dyspnoea 59.32 13.43 168 32324 376614 34547825
Recalled product 58.77 13.43 19 32473 328 34924111
Alcohol withdrawal syndrome 57.65 13.43 28 32464 1458 34922981
Mydriasis 55.06 13.43 49 32443 7188 34917251
General physical health deterioration 52.26 13.43 27 32465 128242 34796197
Accidental death 52.16 13.43 31 32461 2425 34922014
Disease progression 51.61 13.43 18 32474 108059 34816380
Agitation 51.47 13.43 143 32349 57256 34867183
Condition aggravated 50.19 13.43 63 32429 192133 34732306
Arthralgia 49.54 13.43 51 32441 169990 34754449
Pneumonia 49.09 13.43 173 32319 362454 34561985
Alcoholism 46.80 13.43 31 32461 2934 34921505
Alcohol intolerance 46.55 13.43 17 32475 429 34924010
Interstitial lung disease 43.25 13.43 5 32487 65277 34859162
Anaemia 42.87 13.43 96 32396 233239 34691200
Cough 42.64 13.43 46 32446 150094 34774345
Rash 42.28 13.43 90 32402 222662 34701777
Ex-drug abuser 41.29 13.43 12 32480 142 34924297
Drug screen positive 41.02 13.43 32 32460 3911 34920528
Medication error 40.93 13.43 80 32412 25485 34898954
Nausea 40.91 13.43 170 32322 339738 34584701
Road traffic accident 40.11 13.43 64 32428 17386 34907053
Amnesia 39.97 13.43 81 32411 26482 34897957
Oedema peripheral 39.56 13.43 32 32460 119780 34804659
Respiratory tract infection bacterial 39.17 13.43 23 32469 1759 34922680
Pain in extremity 39.08 13.43 36 32456 126477 34797962
Product dose omission issue 38.25 13.43 33 32459 119678 34804761
Sputum culture positive 36.50 13.43 22 32470 1766 34922673
Joint swelling 36.34 13.43 6 32486 59884 34864555
Withdrawal syndrome 36.23 13.43 51 32441 12404 34912035
Myocardial infarction 35.60 13.43 36 32456 121049 34803390
Opiates positive 35.41 13.43 15 32477 566 34923873
Pulmonary oedema 34.59 13.43 110 32382 47419 34877020
Sopor 34.27 13.43 49 32443 12087 34912352
Respiratory tract infection viral 34.22 13.43 24 32468 2493 34921946
Malignant neoplasm progression 33.72 13.43 20 32472 88026 34836413
Treatment failure 32.41 13.43 3 32489 46694 34877745
Physical assault 31.17 13.43 17 32475 1128 34923311
Osteonecrosis of jaw 31.12 13.43 58 32434 17831 34906608
Hepatic fibrosis 30.76 13.43 29 32463 4578 34919861
Weight increased 30.51 13.43 25 32467 93008 34831431
Pain 30.12 13.43 94 32398 204581 34719858
Loss of consciousness 30.00 13.43 154 32338 82513 34841926
Foetal alcohol syndrome 28.95 13.43 9 32483 136 34924303
Weight decreased 28.83 13.43 77 32415 176224 34748215
Impaired driving ability 28.77 13.43 22 32470 2611 34921828
Asthenia 28.62 13.43 124 32368 245127 34679312
Drug abuser 28.55 13.43 26 32466 3928 34920511
Decreased appetite 28.49 13.43 71 32421 166321 34758118
Homicide 28.39 13.43 15 32477 934 34923505
Dehydration 27.67 13.43 49 32443 129920 34794519
Peripheral swelling 27.10 13.43 19 32473 76522 34847917
Chemical burn of skin 26.46 13.43 6 32486 23 34924416
Haemoglobin decreased 26.19 13.43 45 32447 120727 34803712
Blood ethanol 25.79 13.43 8 32484 120 34924319
Renal impairment 25.67 13.43 30 32462 94483 34829956
White blood cell count decreased 25.17 13.43 31 32461 95414 34829025
Back pain 24.96 13.43 47 32445 121742 34802697
Therapeutic product effect incomplete 24.84 13.43 8 32484 50533 34873906
Metabolic acidosis 24.72 13.43 93 32399 43587 34880852
Suicidal behaviour 24.47 13.43 16 32476 1481 34922958
Asthma 24.31 13.43 5 32487 42651 34881788
Cardiac failure congestive 24.19 13.43 25 32467 83245 34841194
Pyrexia 24.17 13.43 196 32296 332817 34591622
Nasopharyngitis 23.95 13.43 18 32474 69950 34854489
Musculoskeletal stiffness 23.64 13.43 7 32485 46673 34877766
Haematochezia 23.53 13.43 7 32485 46527 34877912
Dizziness 23.39 13.43 114 32378 218407 34706032
Dysarthria 23.06 13.43 78 32414 34704 34889735
Sensitisation 22.77 13.43 8 32484 180 34924259
Culture positive 22.76 13.43 12 32480 744 34923695
Cardiac failure 22.66 13.43 31 32461 91217 34833222
Myocardial fibrosis 22.57 13.43 14 32478 1183 34923256
Drug interaction 22.48 13.43 314 32178 225632 34698807
Sensorimotor disorder 22.33 13.43 10 32482 432 34924007
Dextrocardia 21.97 13.43 7 32485 115 34924324
Prostate cancer 21.88 13.43 5 32487 39644 34884795
Brain oedema 21.81 13.43 43 32449 13778 34910661
Suspected transmission of an infectious agent via product 21.47 13.43 12 32480 836 34923603
Renal failure 21.34 13.43 57 32435 130500 34793939
Drug intolerance 20.81 13.43 15 32477 59555 34864884
Gun shot wound 20.78 13.43 13 32479 1115 34923324
Constipation 20.77 13.43 62 32430 136920 34787519
Myalgia 20.46 13.43 29 32463 84081 34840358
Unresponsive to stimuli 20.23 13.43 64 32428 27505 34896934
Respiratory rate decreased 20.01 13.43 17 32475 2342 34922097
Capillary nail refill test abnormal 19.80 13.43 5 32487 33 34924406
Hypotension 19.66 13.43 302 32190 221347 34703092
Accidental poisoning 19.51 13.43 11 32481 779 34923660
Substance-induced mood disorder 19.28 13.43 6 32486 91 34924348
Delirium tremens 18.96 13.43 10 32482 620 34923819
Pruritus 18.94 13.43 68 32424 141913 34782526
Cerebrovascular accident 18.93 13.43 31 32461 84780 34839659
Visceral oedema 18.75 13.43 6 32486 100 34924339
Somnolence 18.57 13.43 171 32321 110945 34813494
Postmortem blood drug level 18.55 13.43 7 32485 194 34924245
Drug diversion 18.42 13.43 11 32481 868 34923571
Blood glucose increased 18.30 13.43 21 32471 66697 34857742
Abdominal pain 18.29 13.43 84 32408 163534 34760905
Respiratory acidosis 18.25 13.43 23 32469 5027 34919412
Amphetamines positive 17.91 13.43 7 32485 214 34924225
Abnormal behaviour 17.44 13.43 57 32435 24912 34899527
Bradypnoea 17.36 13.43 17 32475 2812 34921627
Neutropenia 17.22 13.43 81 32411 156697 34767742
Electrocardiogram repolarisation abnormality 17.07 13.43 11 32481 993 34923446
Haematuria 16.97 13.43 13 32479 50053 34874386
Chest pain 16.72 13.43 61 32431 126701 34797738
Urticaria 16.71 13.43 20 32472 62357 34862082
Inappropriate schedule of product administration 16.67 13.43 20 32472 62276 34862163
Psychiatric disorder prophylaxis 16.57 13.43 5 32487 68 34924371
Behavioural addiction 16.50 13.43 5 32487 69 34924370
Alcoholic liver disease 16.48 13.43 9 32483 599 34923840
Neuropathy peripheral 16.29 13.43 33 32459 83230 34841209
Therapeutic product effect decreased 16.21 13.43 6 32486 34737 34889702
Somnambulism 16.19 13.43 17 32475 3055 34921384
Infection 16.17 13.43 38 32454 90877 34833562
Muscular weakness 15.94 13.43 27 32465 72870 34851569
Blood creatinine increased 15.87 13.43 41 32451 94935 34829504
Shock 15.83 13.43 54 32438 24125 34900314
Behaviour disorder 15.62 13.43 21 32471 4889 34919550
Sinus tachycardia 15.29 13.43 43 32449 17317 34907122
Blood ethanol increased 15.19 13.43 8 32484 495 34923944
Wheezing 15.02 13.43 10 32482 41392 34883047
Sepsis 15.00 13.43 92 32400 166469 34757970
Cytokine release syndrome 14.89 13.43 51 32441 22826 34901613
Drug resistance 14.86 13.43 3 32489 25924 34898515
Haemoptysis 14.79 13.43 7 32485 34999 34889440
Alcoholic pancreatitis 14.75 13.43 6 32486 204 34924235
Hepatitis C virus test positive 14.64 13.43 7 32485 352 34924087
Toxicologic test abnormal 14.43 13.43 8 32484 548 34923891
Deep vein thrombosis 14.42 13.43 24 32468 65224 34859215
Abdominal distension 14.39 13.43 20 32472 58472 34865967
Blood pressure fluctuation 14.30 13.43 3 32489 25246 34899193
Cluster headache 14.30 13.43 8 32484 558 34923881
Urinary tract infection 14.28 13.43 36 32456 84045 34840394
Electrocardiogram QRS complex prolonged 14.17 13.43 20 32472 4874 34919565
Headache 14.10 13.43 119 32373 200516 34723923
Gastrointestinal disorder 14.02 13.43 7 32485 33941 34890498
Pneumonitis 13.97 13.43 7 32485 33871 34890568
Productive cough 13.90 13.43 9 32483 37804 34886635
Therapeutic response decreased 13.78 13.43 5 32487 29308 34895131
Chemical burn 13.72 13.43 6 32486 245 34924194
Benzodiazepine drug level therapeutic 13.71 13.43 4 32488 48 34924391
Chemical poisoning 13.70 13.43 5 32487 126 34924313
Malaise 13.61 13.43 109 32383 185716 34738723
Atrial fibrillation 13.57 13.43 63 32429 122330 34802109

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
Completed suicide 5859.64 14.78 3921 112815 241846 79385806
Drug abuse 4625.00 14.78 2903 113833 159788 79467864
Toxicity to various agents 3671.14 14.78 3747 112989 417793 79209859
Folliculitis 1517.02 14.78 968 115768 54412 79573240
Muscle injury 1509.81 14.78 920 115816 47641 79580011
Irritable bowel syndrome 1440.07 14.78 979 115757 61262 79566390
Sleep disorder due to general medical condition, insomnia type 1327.85 14.78 815 115921 42741 79584911
Lower respiratory tract infection 1111.54 14.78 1146 115590 128074 79499578
Impaired healing 1101.21 14.78 959 115777 86696 79540956
Cardio-respiratory arrest 1101.00 14.78 1053 115683 107457 79520195
Helicobacter infection 1045.73 14.78 845 115891 68859 79558793
Duodenal ulcer perforation 1023.75 14.78 817 115919 65394 79562258
Blister 958.36 14.78 1021 115715 118455 79509197
Stomatitis 811.63 14.78 1036 115700 145721 79481931
Ill-defined disorder 769.71 14.78 692 116044 65183 79562469
Intentional overdose 763.37 14.78 856 115880 105104 79522548
Pericarditis 750.80 14.78 842 115894 103394 79524258
Pemphigus 714.78 14.78 803 115933 98779 79528873
Gastrointestinal disorder 714.19 14.78 887 115849 121318 79506334
Anti-cyclic citrullinated peptide antibody positive 702.82 14.78 731 116005 82412 79545240
Glossodynia 670.51 14.78 791 115945 102546 79525106
Hand deformity 658.67 14.78 786 115950 103133 79524519
Systemic lupus erythematosus 653.50 14.78 845 115891 120304 79507348
Sinusitis 640.54 14.78 1078 115658 194423 79433229
Discomfort 620.24 14.78 839 115897 124778 79502874
Alcohol interaction 614.64 14.78 241 116495 4633 79623019
Wound 591.94 14.78 788 115948 115391 79512261
Synovitis 536.40 14.78 863 115873 149871 79477781
Therapeutic product effect decreased 519.89 14.78 891 115845 162972 79464680
Suspected suicide 494.85 14.78 262 116474 10314 79617338
Swelling 481.27 14.78 1012 115724 215699 79411953
Hepatic enzyme increased 461.60 14.78 900 115836 181710 79445942
Arthropathy 457.56 14.78 881 115855 176230 79451422
Overdose 444.04 14.78 890 115846 183316 79444336
Peripheral swelling 429.47 14.78 1105 115631 268512 79359140
Hypersensitivity 408.62 14.78 1066 115670 261173 79366479
Contraindicated product administered 399.93 14.78 778 115958 156760 79470892
Contusion 396.41 14.78 750 115986 148026 79479626
Nasopharyngitis 384.27 14.78 1021 115715 252860 79374792
Alcohol abuse 382.42 14.78 177 116559 5186 79622466
Intentional product misuse 376.03 14.78 572 116164 94593 79533059
Joint swelling 368.35 14.78 1091 115645 287555 79340097
Confusional state 350.32 14.78 1142 115594 316855 79310797
Alcohol poisoning 343.42 14.78 159 116577 4662 79622990
Infection 326.89 14.78 933 115803 240779 79386873
Alopecia 315.73 14.78 896 115840 230459 79397193
Nausea 311.65 14.78 581 116155 956615 78671037
Suicide attempt 305.94 14.78 483 116253 82449 79545203
Weight increased 303.41 14.78 994 115742 276392 79351260
Pruritus 302.25 14.78 1260 115476 393388 79234264
Exposure to toxic agent 295.84 14.78 178 116558 8980 79618672
Fall 284.32 14.78 182 116554 487447 79140205
Night sweats 272.20 14.78 358 116378 51737 79575915
Abdominal discomfort 271.01 14.78 895 115841 249832 79377820
Infusion related reaction 263.39 14.78 838 115898 229399 79398253
Cough 258.13 14.78 107 116629 366682 79260970
Anaemia 255.42 14.78 169 116567 444846 79182806
Rheumatoid arthritis 253.41 14.78 775 115961 207695 79419957
Muscle spasticity 243.54 14.78 222 116514 21253 79606399
Ear pain 230.33 14.78 262 116474 32607 79595045
Respiratory arrest 225.92 14.78 345 116391 57205 79570447
Pneumonia 218.58 14.78 396 116340 659850 78967802
Product dose omission issue 209.82 14.78 52 116684 247485 79380167
Alcohol use 207.27 14.78 113 116623 4718 79622934
Off label use 203.59 14.78 667 116069 906548 78721104
Maternal exposure during pregnancy 196.07 14.78 539 116197 135999 79491653
Drug intolerance 187.73 14.78 825 115911 263294 79364358
Pain in extremity 185.16 14.78 157 116579 364381 79263271
Substance abuse 182.21 14.78 139 116597 10387 79617265
Deep vein thrombosis postoperative 179.59 14.78 139 116597 10613 79617039
Dehydration 176.77 14.78 71 116665 248116 79379536
Drug dependence 175.17 14.78 255 116481 40514 79587138
Acute kidney injury 168.62 14.78 315 116421 519089 79108563
Incorrect route of product administration 164.11 14.78 228 116508 34701 79592951
Malaise 159.06 14.78 297 116439 489572 79138080
Lip dry 156.74 14.78 150 116586 15268 79612384
Respiratory disorder 147.37 14.78 248 116488 44608 79583044
Facet joint syndrome 144.38 14.78 125 116611 11177 79616475
Myocardial infarction 144.21 14.78 45 116691 184084 79443568
Weight decreased 142.21 14.78 187 116549 355011 79272641
Haemoglobin decreased 141.89 14.78 74 116662 222045 79405607
Diarrhoea 141.28 14.78 737 115999 879752 78747900
Dizziness 141.23 14.78 355 116381 526086 79101566
Body temperature increased 141.19 14.78 242 116494 44178 79583474
Autoimmune disorder 136.50 14.78 144 116592 16468 79611184
Interstitial lung disease 135.83 14.78 7 116729 112593 79515059
Constipation 131.70 14.78 132 116604 282918 79344734
Poisoning deliberate 130.06 14.78 149 116587 18679 79608973
Urinary tract infection 126.59 14.78 129 116607 274383 79353269
Blood alcohol increased 122.11 14.78 52 116684 1243 79626409
Maternal exposure timing unspecified 121.75 14.78 86 116650 5706 79621946
Neutropenia 118.71 14.78 148 116588 287562 79340090
Medication error 118.01 14.78 290 116446 68352 79559300
Blood pressure increased 117.41 14.78 83 116653 211277 79416375
White blood cell count decreased 116.92 14.78 65 116671 188223 79439429
Renal failure 115.53 14.78 76 116660 200892 79426760
Coma 115.48 14.78 367 116369 100282 79527370
Asphyxia 115.32 14.78 112 116624 11608 79616044
Burkholderia test positive 114.62 14.78 40 116696 545 79627107
Cardiac failure congestive 112.94 14.78 34 116702 142368 79485284
Cerebrovascular accident 112.87 14.78 43 116693 155249 79472403
Injection site pain 112.46 14.78 26 116710 129812 79497840
Rash 111.16 14.78 1314 115422 577044 79050608
Burkholderia infection 110.15 14.78 26 116710 69 79627583
Peripheral venous disease 110.06 14.78 126 116610 15783 79611869
Renal impairment 109.29 14.78 47 116689 157736 79469916
Liver injury 109.03 14.78 250 116486 56364 79571288
Therapeutic product effect incomplete 108.45 14.78 36 116700 141609 79486043
Myalgia 106.98 14.78 70 116666 185571 79442081
Cardiac arrest 104.75 14.78 514 116222 171582 79456070
Condition aggravated 102.85 14.78 382 116354 500742 79126910
Road traffic accident 99.08 14.78 206 116530 43458 79584194
Inappropriate schedule of product administration 98.79 14.78 36 116700 133592 79494060
Chills 97.06 14.78 57 116679 160177 79467475
Substance use disorder 96.25 14.78 40 116696 898 79626754
Product contamination microbial 95.92 14.78 40 116696 906 79626746
Pregnancy 94.30 14.78 153 116583 26698 79600954
Syncope 93.83 14.78 75 116661 179374 79448278
Feeling abnormal 93.13 14.78 59 116677 159140 79468512
Bronchitis 91.94 14.78 38 116698 130606 79497046
Pancytopenia 90.84 14.78 66 116670 165679 79461973
Recalled product administered 89.89 14.78 37 116699 810 79626842
Urticaria 89.40 14.78 519 116217 184682 79442970
Thrombocytopenia 87.56 14.78 159 116577 265100 79362552
Intentional product use issue 87.38 14.78 447 116289 151665 79475987
Productive cough 86.50 14.78 13 116723 88318 79539334
Influenza 86.01 14.78 41 116695 129565 79498087
Haematochezia 85.60 14.78 13 116723 87632 79540020
Platelet count decreased 84.67 14.78 96 116640 194568 79433084
Malignant neoplasm progression 84.33 14.78 47 116689 135943 79491709
Blood glucose increased 83.27 14.78 32 116704 114943 79512709
Hyponatraemia 82.60 14.78 83 116653 177765 79449887
Rheumatic fever 82.35 14.78 149 116587 28376 79599276
Gastrointestinal haemorrhage 82.02 14.78 58 116678 147661 79479991
Disease progression 80.09 14.78 91 116645 184271 79443381
Blood pressure fluctuation 78.44 14.78 5 116731 67140 79560512
Rheumatoid factor positive 77.79 14.78 228 116508 59611 79568041
Cardiac failure 76.91 14.78 68 116668 154774 79472878
COVID-19 76.22 14.78 71 116665 157603 79470049
Hyperkalaemia 76.20 14.78 36 116700 114362 79513290
Injection site erythema 75.45 14.78 12 116724 78185 79549467
Poisoning 74.22 14.78 133 116603 25139 79602513
Vision blurred 74.19 14.78 31 116705 105867 79521785
Aggression 73.89 14.78 202 116534 50756 79576896
Headache 73.28 14.78 609 116127 653163 78974489
Arthritis 72.25 14.78 39 116697 114841 79512811
Deep vein thrombosis 71.84 14.78 44 116692 120875 79506777
Decreased appetite 71.49 14.78 259 116477 342159 79285493
Leukopenia 71.19 14.78 41 116695 116472 79511180
Atrial fibrillation 70.44 14.78 113 116623 197773 79429879
Oropharyngeal pain 70.43 14.78 36 116700 109317 79518335
Respiratory depression 69.41 14.78 136 116600 27494 79600158
Drug use disorder 69.31 14.78 74 116662 8577 79619075
Swollen joint count increased 69.05 14.78 122 116614 22805 79604847
Chronic obstructive pulmonary disease 68.43 14.78 20 116716 85399 79542253
Abdominal pain 68.00 14.78 316 116420 389253 79238399
Lower limb fracture 67.95 14.78 122 116614 23093 79604559
Balance disorder 67.56 14.78 30 116706 98827 79528825
C-reactive protein 67.53 14.78 57 116679 4922 79622730
Erythema 67.47 14.78 141 116595 223149 79404503
Diabetes mellitus 67.27 14.78 16 116720 78374 79549278
Chest discomfort 66.91 14.78 62 116674 137982 79489670
Psoriasis 66.44 14.78 24 116712 89563 79538089
Pulmonary embolism 65.95 14.78 93 116643 171561 79456091
Cardiac disorder 63.65 14.78 10 116726 65747 79561905
Gait disturbance 61.88 14.78 132 116604 207374 79420278
Herpes zoster 60.91 14.78 30 116706 93053 79534599
Sepsis 60.82 14.78 197 116539 269231 79358421
Postmortem blood drug level abnormal 60.80 14.78 26 116710 628 79627024
Angioedema 60.55 14.78 18 116718 76017 79551635
Acute myocardial infarction 59.97 14.78 19 116717 77017 79550635
Mydriasis 59.88 14.78 99 116637 17544 79610108
Blood creatinine increased 58.58 14.78 85 116651 154972 79472680
Stress 57.90 14.78 22 116714 79590 79548062
Abdominal distension 57.68 14.78 54 116682 119596 79508056
Injury 57.16 14.78 245 116491 77251 79550401
Nasal congestion 55.93 14.78 21 116715 76531 79551121
Influenza like illness 55.26 14.78 18 116718 71689 79555963
Upper respiratory tract infection 54.39 14.78 33 116703 91135 79536517
Gastrooesophageal reflux disease 53.93 14.78 44 116692 104202 79523450
Oedema peripheral 53.85 14.78 189 116547 252099 79375553
Thrombosis 53.69 14.78 28 116708 84072 79543580
Sleep disorder 53.59 14.78 258 116478 85419 79542233
Haematuria 53.54 14.78 17 116719 68819 79558833
Febrile neutropenia 53.46 14.78 167 116569 230832 79396820
Alcoholism 53.35 14.78 44 116692 3679 79623973
Fluid retention 52.97 14.78 18 116718 69791 79557861
Dyspnoea exertional 52.68 14.78 31 116705 87042 79540610
Pleural effusion 52.58 14.78 82 116654 145180 79482472
Hip arthroplasty 52.10 14.78 142 116594 35614 79592038
Chronic kidney disease 52.06 14.78 16 116720 66138 79561514
Neck pain 51.36 14.78 23 116713 75394 79552258
Dysphagia 51.19 14.78 62 116674 122074 79505578
Drug ineffective 51.07 14.78 1200 115536 1079713 78547939
Haemoptysis 50.96 14.78 10 116726 55989 79571663
Heart rate increased 50.90 14.78 61 116675 120663 79506989
Skin exfoliation 49.81 14.78 10 116726 55090 79572562
Incorrect dose administered 49.68 14.78 25 116711 76605 79551047
Bursitis 48.92 14.78 139 116597 35705 79591947
International normalised ratio increased 48.71 14.78 32 116704 84689 79542963
Agranulocytosis 48.04 14.78 5 116731 45025 79582627
Septic shock 47.69 14.78 66 116670 122735 79504917
Rhinorrhoea 47.57 14.78 26 116710 76048 79551604
Joint range of motion decreased 47.32 14.78 131 116605 33151 79594501
Neutrophil count decreased 46.96 14.78 41 116695 93918 79533734
Drug reaction with eosinophilia and systemic symptoms 46.31 14.78 18 116718 64226 79563426
Blood pressure systolic increased 46.29 14.78 20 116716 66966 79560686
Palpitations 46.27 14.78 71 116665 126539 79501113
Accidental death 46.00 14.78 43 116693 4248 79623404
Recalled product 45.66 14.78 24 116712 930 79626722
C-reactive protein abnormal 45.44 14.78 165 116571 48202 79579450
Intestinal obstruction 45.32 14.78 5 116731 43015 79584637
X-ray abnormal 45.30 14.78 49 116687 5764 79621888
Hyperhidrosis 44.62 14.78 97 116639 151395 79476257
Visual impairment 43.91 14.78 42 116694 92089 79535563
Cataract 43.80 14.78 18 116718 62102 79565550
Injection site swelling 43.78 14.78 8 116728 47124 79580528
Chemical submission 43.67 14.78 17 116719 320 79627332
Rash maculo-papular 43.35 14.78 14 116722 56064 79571588
Obesity 42.96 14.78 131 116605 34994 79592658
Dysphonia 42.57 14.78 15 116721 56857 79570795
Cellulitis 41.96 14.78 59 116677 109001 79518651
Drug eruption 41.80 14.78 7 116729 43928 79583724
Orthostatic hypotension 41.72 14.78 15 116721 56149 79571503
Angina pectoris 41.64 14.78 12 116724 51720 79575932
Prescribed overdose 41.49 14.78 136 116600 37747 79589905
Miosis 41.22 14.78 79 116657 15710 79611942
Fibromyalgia 41.14 14.78 195 116541 64145 79563507
Transient ischaemic attack 41.01 14.78 13 116723 52682 79574970
Respiratory failure 41.00 14.78 132 116604 180779 79446873
Toxic epidermal necrolysis 40.48 14.78 8 116728 44573 79583079
Prescription drug used without a prescription 40.12 14.78 39 116697 4046 79623606
Coronary artery disease 40.04 14.78 23 116713 65451 79562201
Haematocrit decreased 39.75 14.78 20 116716 61292 79566360
Drug resistance 39.56 14.78 7 116729 42206 79585446
Full blood count abnormal 39.52 14.78 6 116730 40468 79587184
Adjustment disorder with depressed mood 39.26 14.78 57 116679 9029 79618623
Ascites 38.95 14.78 32 116704 75530 79552122
Multiple sclerosis relapse 38.95 14.78 10 116726 46523 79581129
Hepatic function abnormal 38.89 14.78 30 116706 73077 79554575
Vertigo 38.50 14.78 27 116709 69055 79558597
Red blood cell count decreased 38.44 14.78 18 116718 57495 79570157
Diverticulitis 38.20 14.78 10 116726 45926 79581726
Blood cholesterol increased 38.03 14.78 231 116505 83489 79544163
Alcohol withdrawal syndrome 38.02 14.78 28 116708 1983 79625669
Disease recurrence 37.85 14.78 9 116727 44100 79583552
Basal cell carcinoma 37.76 14.78 5 116731 37370 79590282
Osteoporosis 37.64 14.78 16 116720 54096 79573556
Therapeutic response decreased 37.42 14.78 26 116710 66827 79560825
Muscular weakness 37.31 14.78 116 116620 160613 79467039
Hypothyroidism 37.24 14.78 15 116721 52377 79575275
Psoriatic arthropathy 36.57 14.78 217 116519 77782 79549870
Heart rate irregular 36.54 14.78 3 116733 32676 79594976
Melaena 36.37 14.78 22 116714 60868 79566784
Opiates positive 36.32 14.78 21 116715 983 79626669
Wrong technique in product usage process 36.00 14.78 33 116703 73842 79553810
Urticaria thermal 35.87 14.78 16 116720 429 79627223
Throat irritation 35.84 14.78 8 116728 40938 79586714
Haematoma 35.41 14.78 16 116720 52179 79575473
Adverse event 35.28 14.78 178 116558 60036 79567616
Myelosuppression 35.02 14.78 8 116728 40288 79587364
Diplopia 34.98 14.78 4 116732 33462 79594190
Product prescribing error 34.97 14.78 11 116725 44802 79582850
Femur fracture 34.96 14.78 7 116729 38645 79589007
Blood urea increased 34.62 14.78 14 116722 48776 79578876
Palmar-plantar erythrodysaesthesia syndrome 34.53 14.78 4 116732 33130 79594522
Cystitis 34.49 14.78 17 116719 52715 79574937
Haemorrhage 34.35 14.78 50 116686 91068 79536584
Limb discomfort 34.15 14.78 4 116732 32846 79594806
Cholestasis 33.78 14.78 17 116719 52092 79575560
Blood ethanol 33.77 14.78 12 116724 173 79627479
Insomnia 33.71 14.78 525 116211 244645 79383007
Injection site pruritus 33.68 14.78 10 116726 42273 79585379
Neuropathy peripheral 33.50 14.78 101 116635 141204 79486448
Bone pain 33.49 14.78 20 116716 55722 79571930
Renal disorder 33.46 14.78 10 116726 42095 79585557
Intentional self-injury 33.38 14.78 114 116622 32305 79595347
Hepatocellular injury 33.22 14.78 14 116722 47579 79580073
Victim of sexual abuse 33.14 14.78 16 116720 516 79627136
Homicide 33.09 14.78 21 116715 1165 79626487
Lymphocyte count decreased 32.86 14.78 14 116722 47275 79580377
Hypertension 32.73 14.78 318 116418 330674 79296978
Abdominal pain lower 32.72 14.78 4 116732 31778 79595874
Bone marrow failure 32.64 14.78 17 116719 51090 79576562
Cerebral infarction 32.59 14.78 13 116723 45663 79581989
Oxygen saturation decreased 32.22 14.78 90 116646 128957 79498695
Nephrolithiasis 32.19 14.78 19 116717 53272 79574380
Swelling face 32.17 14.78 34 116702 71178 79556474
Bradycardia 32.05 14.78 97 116639 135460 79492192
Cognitive disorder 32.03 14.78 33 116703 69893 79557759
Neoplasm progression 31.83 14.78 18 116718 51664 79575988
Rash pruritic 31.47 14.78 35 116701 71594 79556058
Pneumocystis jirovecii pneumonia 31.33 14.78 5 116731 32503 79595149
Burning sensation 31.26 14.78 24 116712 58608 79569044
Pneumonitis 31.09 14.78 26 116710 60834 79566818
Injection site reaction 31.07 14.78 21 116715 54764 79572888
Body temperature decreased 30.85 14.78 5 116731 32140 79595512
Burkholderia cepacia complex infection 30.75 14.78 13 116723 305 79627347
Flatulence 30.74 14.78 12 116724 42712 79584940
Rectal haemorrhage 30.64 14.78 40 116696 76260 79551392
Urinary retention 30.43 14.78 23 116713 56607 79571045
Ulcer 30.30 14.78 4 116732 29968 79597684
Asthenia 30.27 14.78 547 116189 511142 79116510
Sleep apnoea syndrome 30.22 14.78 8 116728 36470 79591182
Amphetamines positive 29.84 14.78 13 116723 329 79627323
Dysstasia 29.81 14.78 3 116733 27743 79599909
Postmortem blood drug level 29.62 14.78 13 116723 335 79627317
Jaundice 29.53 14.78 21 116715 53328 79574324
Plasma cell myeloma 29.43 14.78 21 116715 53238 79574414
Oral herpes 29.41 14.78 3 116733 27451 79600201
Diabetic ketoacidosis 29.20 14.78 7 116729 34115 79593537
Proteinuria 29.16 14.78 6 116730 32496 79595156
Acne 29.05 14.78 3 116733 27187 79600465
Illness 28.93 14.78 16 116720 46495 79581157
Colitis 28.86 14.78 39 116697 73268 79554384
Alanine aminotransferase increased 28.83 14.78 131 116605 162439 79465213
Pyrexia 28.80 14.78 1241 115495 677468 78950184
Anti-cyclic citrullinated peptide antibody 28.68 14.78 39 116697 5813 79621839
C-reactive protein increased 28.63 14.78 95 116641 128932 79498720
Drug interaction 28.43 14.78 432 116304 414751 79212901
Blood pressure decreased 28.21 14.78 65 116671 99401 79528251
Lymphadenopathy 28.13 14.78 22 116714 53225 79574427
Tremor 27.86 14.78 141 116595 169942 79457710
Cerebral haemorrhage 27.82 14.78 26 116710 57647 79570005
Joint injury 27.67 14.78 6 116730 31329 79596323
Death 27.51 14.78 1051 115685 565463 79062189
Lung neoplasm malignant 27.41 14.78 4 116732 27788 79599864
Gastroenteritis 27.26 14.78 8 116728 34074 79593578
Hypocalcaemia 27.18 14.78 20 116716 49904 79577748
Gastric ulcer 27.04 14.78 8 116728 33897 79593755
Movement disorder 26.71 14.78 4 116732 27255 79600397
Respiratory tract infection bacterial 26.58 14.78 23 116713 2054 79625598
Pulmonary hypertension 26.51 14.78 19 116717 48061 79579591
Pancreatitis 26.47 14.78 37 116699 68538 79559114
Viral infection 26.46 14.78 15 116721 43001 79584651
Feeling hot 26.45 14.78 29 116707 59705 79567947
Feeling cold 26.41 14.78 5 116731 28724 79598928
Neoplasm malignant 26.31 14.78 7 116729 31803 79595849
Dysgeusia 26.17 14.78 27 116709 57150 79570502
Full blood count decreased 26.13 14.78 4 116732 26815 79600837
Drug ineffective for unapproved indication 26.04 14.78 22 116714 51216 79576436
Swollen tongue 25.96 14.78 15 116721 42555 79585097
Metastases to liver 25.88 14.78 5 116731 28309 79599343
Agitation 25.85 14.78 241 116495 99474 79528178
Subdural haematoma 25.84 14.78 7 116729 31427 79596225
Therapy interrupted 25.73 14.78 7 116729 31334 79596318
Dementia 25.64 14.78 3 116733 24656 79602996
Dry eye 25.56 14.78 11 116725 36920 79590732
Red blood cell sedimentation rate increased 25.54 14.78 18 116718 45924 79581728
Depression 25.54 14.78 199 116537 216591 79411061
Knee arthroplasty 25.44 14.78 128 116608 43120 79584532
Fungal infection 25.05 14.78 15 116721 41733 79585919
Eosinophilia 24.90 14.78 18 116718 45327 79582325
Faeces discoloured 24.88 14.78 6 116730 29121 79598531
Pallor 24.82 14.78 22 116714 50040 79577612
Iron deficiency anaemia 24.63 14.78 4 116732 25668 79601984
Loss of personal independence in daily activities 24.54 14.78 73 116663 102507 79525145
Gait inability 24.53 14.78 159 116577 58758 79568894
Electrocardiogram QRS complex prolonged 24.44 14.78 51 116685 10782 79616870
Myelodysplastic syndrome 24.44 14.78 7 116729 30294 79597358
Chest pain 24.34 14.78 280 116456 282024 79345628
Device issue 24.33 14.78 5 116731 27103 79600549
Pain 24.33 14.78 1261 115475 702541 78925111
Victim of chemical submission 23.88 14.78 13 116723 541 79627111
Blood ethanol increased 23.76 14.78 14 116722 679 79626973
Oral candidiasis 23.61 14.78 7 116729 29621 79598031
Mucosal inflammation 23.42 14.78 47 116689 75533 79552119
Injection site haemorrhage 23.30 14.78 6 116730 27864 79599788
Therapy cessation 23.25 14.78 13 116723 37549 79590103
Skin ulcer 23.20 14.78 27 116709 54123 79573529
Multiple organ dysfunction syndrome 23.09 14.78 94 116642 120152 79507500
Gastritis 22.72 14.78 22 116714 47971 79579681
Alcohol intolerance 22.64 14.78 12 116724 473 79627179
Tinnitus 22.57 14.78 19 116717 44314 79583338
Corneal defect 22.51 14.78 5 116731 9 79627643
Abdominal pain upper 22.45 14.78 456 116280 223363 79404289
Hyperglycaemia 22.43 14.78 43 116693 70292 79557360
Sciatica 22.19 14.78 102 116634 33120 79594532
Drug abuser 22.12 14.78 35 116701 5978 79621674
Hypotension 22.02 14.78 484 116252 439833 79187819
Drug screen positive 21.90 14.78 35 116701 6028 79621624
Localised infection 21.86 14.78 14 116722 37561 79590091
White blood cell count increased 21.79 14.78 48 116688 74585 79553067
Cholelithiasis 21.78 14.78 27 116709 52637 79575015
Colitis ulcerative 21.54 14.78 12 116724 34730 79592922
Rash erythematous 21.48 14.78 32 116704 57737 79569915
Stevens-Johnson syndrome 20.92 14.78 16 116720 39150 79588502
Blood pressure diastolic decreased 20.91 14.78 9 116727 30207 79597445
Upper gastrointestinal haemorrhage 20.74 14.78 18 116718 41362 79586290
Type 2 diabetes mellitus 20.71 14.78 149 116587 56973 79570679
Lupus vulgaris 20.65 14.78 25 116711 3321 79624331
Angiokeratoma 20.65 14.78 9 116727 228 79627424
Conjunctivitis 20.63 14.78 6 116730 25709 79601943
Aspartate aminotransferase increased 20.46 14.78 119 116617 138522 79489130
Pulmonary arterial hypertension 20.35 14.78 8 116728 28358 79599294
Hyperthyroidism 20.13 14.78 4 116732 22205 79605447
Frequent bowel movements 20.12 14.78 9 116727 29530 79598122
Hypophagia 20.11 14.78 22 116714 45345 79582307
Abortion spontaneous 20.08 14.78 9 116727 29498 79598154
Heart rate decreased 19.90 14.78 46 116690 70270 79557382
Palmar erythema 19.90 14.78 19 116717 1928 79625724
Blood sodium decreased 19.88 14.78 12 116724 33243 79594409
Vasculitis 19.88 14.78 6 116730 25096 79602556
Drug hypersensitivity 19.77 14.78 313 116423 298603 79329049
Eye swelling 19.77 14.78 7 116729 26461 79601191
Ischaemic stroke 19.75 14.78 12 116724 33119 79594533
Kidney infection 19.67 14.78 4 116732 21847 79605805
Eye disorder 19.65 14.78 5 116731 23407 79604245
Vaginal haemorrhage 19.63 14.78 4 116732 21813 79605839
Immunodeficiency 19.57 14.78 4 116732 21764 79605888
Gastroenteritis viral 19.55 14.78 6 116730 24825 79602827
Dyskinesia 19.53 14.78 22 116714 44751 79582901
Labelled drug-drug interaction medication error 19.51 14.78 8 116728 27642 79600010
Protein C increased 19.50 14.78 7 116729 104 79627548
Substance dependence 19.46 14.78 11 116725 493 79627159
Neuroleptic malignant syndrome 19.40 14.78 8 116728 27551 79600101
Haematemesis 19.39 14.78 29 116707 52235 79575417
Toxicologic test abnormal 19.34 14.78 16 116720 1344 79626308
Muscle rigidity 19.29 14.78 3 116733 19879 79607773
Amnesia 19.25 14.78 158 116578 62899 79564753
Flank pain 19.24 14.78 3 116733 19841 79607811
Bacterial infection 19.11 14.78 11 116725 31269 79596383
Hepatic cytolysis 18.93 14.78 8 116728 27143 79600509
Oesophagitis 18.88 14.78 6 116730 24283 79603369
Dry skin 18.83 14.78 45 116691 67950 79559702
Polyneuropathy 18.72 14.78 6 116730 24145 79603507
Arthralgia 18.62 14.78 1019 115717 570784 79056868
Limb injury 18.59 14.78 10 116726 29518 79598134
Cytomegalovirus infection 18.55 14.78 21 116715 42623 79585029
Platelet count increased 18.40 14.78 5 116731 22401 79605251
Aspergillus infection 18.35 14.78 3 116733 19158 79608494
Appendicitis 18.33 14.78 4 116732 20790 79606862
Post procedural complication 18.33 14.78 6 116730 23823 79603829
Rib fracture 18.29 14.78 9 116727 27938 79599714
Asthenopia 18.11 14.78 20 116716 2407 79625245
Pancreatitis acute 17.94 14.78 28 116708 49576 79578076
Posterior reversible encephalopathy syndrome 17.91 14.78 8 116728 26273 79601379
Gastric disorder 17.91 14.78 17 116719 37416 79590236
Pollakiuria 17.79 14.78 17 116719 37300 79590352
Hypercalcaemia 17.75 14.78 18 116718 38412 79589240
Unevaluable event 17.71 14.78 34 116702 55551 79572101
Dry mouth 17.70 14.78 202 116534 87817 79539835
Back pain 17.69 14.78 326 116410 303854 79323798
Migraine 17.68 14.78 67 116669 87426 79540226
Dislocation of vertebra 17.66 14.78 37 116699 7843 79619809
Fracture 17.65 14.78 5 116731 21796 79605856
Mitral valve incompetence 17.51 14.78 10 116726 28555 79599097
Cystitis noninfective 17.48 14.78 15 116721 1325 79626327
Ejection fraction 17.46 14.78 19 116717 2250 79625402
Procedural pain 17.43 14.78 6 116730 23078 79604574
Rales 17.32 14.78 4 116732 19997 79607655
Chromaturia 17.29 14.78 8 116728 25738 79601914
Sinus congestion 17.19 14.78 4 116732 19892 79607760
Musculoskeletal discomfort 17.11 14.78 4 116732 19831 79607821
Metastases to lung 17.05 14.78 3 116733 18160 79609492
Physical assault 16.99 14.78 16 116720 1595 79626057
Suspected transmission of an infectious agent via product 16.96 14.78 14 116722 1172 79626480
Sneezing 16.92 14.78 4 116732 19679 79607973
Blood potassium increased 16.90 14.78 11 116725 29264 79598388
Lip swelling 16.89 14.78 21 116715 40890 79586762
Cardiovascular disorder 16.87 14.78 3 116733 18022 79609630
Joint effusion 16.85 14.78 3 116733 18011 79609641
Photosensitivity reaction 16.82 14.78 5 116731 21122 79606530
Injection site rash 16.77 14.78 3 116733 17951 79609701
Sputum culture positive 16.74 14.78 24 116712 3757 79623895
Surgery 16.73 14.78 14 116722 32752 79594900
Obstructive airways disorder 16.61 14.78 13 116723 31446 79596206
Transplant rejection 16.61 14.78 4 116732 19433 79608219
Mouth ulceration 16.60 14.78 19 116717 38375 79589277
Dysmetropsia 16.60 14.78 6 116730 91 79627561
Breast cancer 16.56 14.78 15 116721 33766 79593886
Pseudomonas infection 16.55 14.78 5 116731 20898 79606754
Hemiparesis 16.51 14.78 15 116721 33718 79593934
Hypoacusis 16.51 14.78 12 116724 30138 79597514
Gallbladder disorder 16.49 14.78 4 116732 19336 79608316
Vaginal cellulitis 16.49 14.78 6 116730 93 79627559
Glycosylated haemoglobin increased 16.39 14.78 4 116732 19256 79608396
Eye pruritus 16.14 14.78 5 116731 20565 79607087
Petechiae 16.13 14.78 5 116731 20560 79607092
Myocardial fibrosis 16.12 14.78 16 116720 1702 79625950
Foot fracture 16.10 14.78 6 116730 21975 79605677
Congestive hepatopathy 16.08 14.78 26 116710 4521 79623131
Hospitalisation 16.07 14.78 77 116659 94159 79533493
Therapy non-responder 16.01 14.78 206 116530 92099 79535553
Nephropathy toxic 15.95 14.78 5 116731 20414 79607238
Blindness 15.93 14.78 11 116725 28372 79599280
Underdose 15.92 14.78 15 116721 33136 79594516
Capillary nail refill test abnormal 15.91 14.78 5 116731 48 79627604
Urinary incontinence 15.86 14.78 22 116714 40887 79586765
Blood calcium decreased 15.75 14.78 14 116722 31805 79595847
Product use in unapproved indication 15.61 14.78 265 116471 250094 79377558
Product use issue 15.61 14.78 410 116326 209412 79418240
Delirium tremens 15.61 14.78 11 116725 727 79626925
Skin disorder 15.56 14.78 16 116720 33927 79593725
Visceral oedema 15.51 14.78 6 116730 111 79627541
Spinal compression fracture 15.49 14.78 3 116733 16955 79610697
No adverse event 15.45 14.78 19 116717 37173 79590479
Haemorrhoids 15.43 14.78 12 116724 29116 79598536
Anaphylactic reaction 15.43 14.78 189 116547 83554 79544098
Throat tightness 15.42 14.78 11 116725 27896 79599756
Candida infection 15.38 14.78 20 116716 38194 79589458
Induced abortion failed 15.32 14.78 7 116729 199 79627453
Behavioural addiction 15.30 14.78 5 116731 55 79627597
Blood urine present 15.29 14.78 6 116730 21291 79606361
Tumour lysis syndrome 15.23 14.78 8 116728 23931 79603721
Blood potassium decreased 15.21 14.78 28 116708 46484 79581168
Substance-induced mood disorder 15.12 14.78 6 116730 119 79627533
Hypoglycaemia 15.09 14.78 87 116649 101507 79526145
Sinus disorder 15.06 14.78 7 116729 22457 79605195
Pharyngitis 14.96 14.78 7 116729 22368 79605284
Blood glucose decreased 14.95 14.78 10 116726 26224 79601428
Skin necrosis 14.92 14.78 4 116732 18083 79609569
Tenderness 14.90 14.78 8 116728 23634 79604018
Anxiety 14.87 14.78 265 116471 248247 79379405
Toxic skin eruption 14.86 14.78 7 116729 22286 79605366

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC A01AB03 ALIMENTARY TRACT AND METABOLISM
STOMATOLOGICAL PREPARATIONS
STOMATOLOGICAL PREPARATIONS
Antiinfectives and antiseptics for local oral treatment
ATC B05CA02 BLOOD AND BLOOD FORMING ORGANS
BLOOD SUBSTITUTES AND PERFUSION SOLUTIONS
IRRIGATING SOLUTIONS
Antiinfectives
ATC D08AC02 DERMATOLOGICALS
ANTISEPTICS AND DISINFECTANTS
ANTISEPTICS AND DISINFECTANTS
Biguanides and amidines
ATC D08AC52 DERMATOLOGICALS
ANTISEPTICS AND DISINFECTANTS
ANTISEPTICS AND DISINFECTANTS
Biguanides and amidines
ATC D09AA12 DERMATOLOGICALS
MEDICATED DRESSINGS
MEDICATED DRESSINGS
Medicated dressings with antiinfectives
ATC R02AA05 RESPIRATORY SYSTEM
THROAT PREPARATIONS
THROAT PREPARATIONS
Antiseptics
ATC S01AX09 SENSORY ORGANS
OPHTHALMOLOGICALS
ANTIINFECTIVES
Other antiinfectives
ATC S02AA09 SENSORY ORGANS
OTOLOGICALS
ANTIINFECTIVES
Antiinfectives
ATC S03AA04 SENSORY ORGANS
OPHTHALMOLOGICAL AND OTOLOGICAL PREPARATIONS
ANTIINFECTIVES
Antiinfectives
FDA PE N0000008478 Decreased Cell Wall Integrity
MeSH PA D000890 Anti-Infective Agents
MeSH PA D000891 Anti-Infective Agents, Local
MeSH PA D003879 Dermatologic Agents
CHEBI has role CHEBI:33282 bactericides
CHEBI has role CHEBI:35441 antiinfective agents
MeSH PA D003358 Cosmetics
MeSH PA D004202 Disinfectants
MeSH PA D009067 Mouthwashes

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

DiseaseRelationSNOMED_IDDOID
Gingivitis indication 66383009 DOID:3087
Mouth Infection Prevention indication
Denture stomatitis off-label use 69254008 DOID:11875
Aphthous ulcer of mouth off-label use 426965005 DOID:9663
Dental Plaque Prevention off-label use
Periodontitis contraindication 41565005 DOID:824
Open wound contraindication 125643001
Front Tooth Fillings contraindication




🐶 Veterinary Drug Use

SpeciesUseRelation
Cats Topical antiseptic for surface wounds Indication
Cattle Metritis Indication
Cattle Vaginitis Indication
Dogs Topical antiseptic for surface wounds Indication
Horses Topical antiseptic for surface wounds Indication
Horses Metritis Indication
Horses Vaginitis Indication

🐶 Veterinary products

ProductApplicantIngredients
Nolvasan Antiseptic Ointment Zoetis Inc. 1
Nolvasan Cap-Tabs Zoetis Inc. 1
Nolvasan Suspension Zoetis Inc. 1
Privasan Antiseptic Ointment First Priority Inc. 1

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 11.17 Basic
pKa2 10.57 Basic
pKa3 3.32 Basic
pKa4 2.72 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
2% CHLORHEXIDINE GLUCONATE SAGE PRODS N021669 April 25, 2005 OTC CLOTH TOPICAL 7595021 May 12, 2023 FOR THE PREPARATION OF SKIN PRIOR TO SURGERY; HELPS REDUCE BACTERIA THAT CAN POTENTIALLY CAUSE SKIN INFECTION
2% CHLORHEXIDINE GLUCONATE SAGE PRODS N021669 April 25, 2005 OTC CLOTH TOPICAL 7066916 Feb. 17, 2024 DISINFECTION OF PATIENT SKIN PRIOR TO AN INVASIVE PROCEDURE
2% CHLORHEXIDINE GLUCONATE SAGE PRODS N021669 April 25, 2005 OTC CLOTH TOPICAL 7717889 Feb. 27, 2025 FOR THE PREPARATION OF SKIN PRIOR TO SURGERY; HELPS REDUCE BACTERIA THAT CAN POTENTIALLY CAUSE SKIN INFECTION
2%;70% (10.5ML) CHLORAPREP WITH TINT BECTON DICKINSON CO N020832 April 3, 2006 OTC SPONGE TOPICAL 7422388 April 25, 2027 USE AS AN ANTISEPTIC FOR THE PREPARATION OF A PATIENTS SKIN PRIOR TO SURGERY
2%;70% (26ML) CHLORAPREP WITH TINT BECTON DICKINSON CO N020832 May 3, 2005 OTC SPONGE TOPICAL 7422388 April 25, 2027 USE AS AN ANTISEPTIC FOR THE PREPARATION OF A PATIENTS SKIN PRIOR TO SURGERY
2%;70% (3ML) CHLORAPREP WITH TINT BECTON DICKINSON CO N020832 Oct. 10, 2006 OTC SPONGE TOPICAL 7422388 April 25, 2027 USE AS AN ANTISEPTIC FOR THE PREPARATION OF A PATIENTS SKIN PRIOR TO SURGERY
2% CHLORHEXIDINE GLUCONATE SAGE PRODS N021669 April 25, 2005 OTC CLOTH TOPICAL 7935093 Oct. 2, 2027 FOR THE PREPARATION OF SKIN PRIOR TO SURGERY; HELPS REDUCE BACTERIA THAT CAN POTENTIALLY CAUSE SKIN INFECTION

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
2%;70% SOLUPREP S 3M HEALTH CARE N208288 Aug. 8, 2018 OTC SOLUTION TOPICAL Jan. 20, 2026 REVISIONS TO THE LABELING TO DESCRIBE MODIFIED FORMULATION BASED ON RESULTS OF STUDIES EM-05-014624 AND EM-05-014815

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])		Mechanism
action		Bioact sourceMoA source
72 kDa type IV collagenase Enzyme IC50 5.12 CHEMBL
Matrix metalloproteinase-9 Enzyme IC50 5.12 CHEMBL
Solute carrier family 22 member 1 Transporter IC50 6.68 CHEMBL
Solute carrier family 22 member 2 Transporter IC50 6.40 CHEMBL
Multidrug and toxin extrusion protein 1 Transporter IC50 6.15 CHEMBL
Multidrug and toxin extrusion protein 2 Transporter IC50 6.30 CHEMBL
Solute carrier family 22 member 3 Transporter IC50 6.39 CHEMBL
Synaptojanin-2 Enzyme IC50 5 CHEMBL
Trypanothione reductase Enzyme Ki 5.70 CHEMBL
CAAX prenyl protease 2 Enzyme AC50 5.24 CHEMBL

External reference:

IDSource
D00858 KEGG_DRUG
3697-42-5 SECONDARY_CAS_RN
18472-51-0 SECONDARY_CAS_RN
20791 RXNORM
4019393 VANDF
4019673 VANDF
C0008196 UMLSCUI
CHEBI:3614 CHEBI
XC9 PDB_CHEM_ID
CHEMBL790 ChEMBL_ID
CHEMBL1484251 ChEMBL_ID
CHEMBL4297088 ChEMBL_ID
CHEMBL1628 ChEMBL_ID
D002710 MESH_DESCRIPTOR_UI
DB00878 DRUGBANK_ID
C010882 MESH_SUPPLEMENTAL_RECORD_UI
500 INN_ID
R4KO0DY52L UNII
9552079 PUBCHEM_CID
4411 MMSL
6085 MMSL
003177 NDDF
003674 NDDF
003722 NDDF
003723 NDDF
108895000 SNOMEDCT_US
373568007 SNOMEDCT_US
96316004 SNOMEDCT_US
96317008 SNOMEDCT_US
96318003 SNOMEDCT_US
CHEMBL486819 ChEMBL_ID
56-95-1 SECONDARY_CAS_RN

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Chlorhexidine Gluconate 0.12% Oral Rinse HUMAN PRESCRIPTION DRUG LABEL 1 0116-0003 LIQUID 1.20 [iU] BUCCAL ANDA 18 sections
Bactoshield CHG HUMAN OTC DRUG LABEL 1 0116-0038 SOLUTION 2 mg TOPICAL NDA 14 sections
Bactoshield CHG HUMAN OTC DRUG LABEL 1 0116-0039 SOLUTION 2 mg TOPICAL NDA 14 sections
Bactoshield CHG HUMAN OTC DRUG LABEL 1 0116-0039 SOLUTION 2 mg TOPICAL NDA 14 sections
Chlorhexidine Gluconate HUMAN PRESCRIPTION DRUG LABEL 1 0116-0101 LIQUID 0.12 mg ORAL ANDA 17 sections
Cardinal Health Antiseptic Skin Cleanser HUMAN OTC DRUG LABEL 1 0116-0113 SOLUTION 2 g TOPICAL NDA 14 sections
Antiseptic Skin Cleanser HUMAN OTC DRUG LABEL 1 0116-0115 LIQUID 4 mg TOPICAL NDA 14 sections
Antiseptic Skin Cleanser HUMAN OTC DRUG LABEL 1 0116-0137 LIQUID 4 mg TOPICAL NDA 14 sections
Antiseptic Skin Cleanser HUMAN OTC DRUG LABEL 1 0116-0161 LIQUID 4 mg TOPICAL NDA 14 sections
Antiseptic Skin Cleanser HUMAN OTC DRUG LABEL 1 0116-0162 LIQUID 4 mg TOPICAL NDA 14 sections
Chlorhexidine Gluconate HUMAN PRESCRIPTION DRUG LABEL 1 0116-0175 RINSE 1.20 mg ORAL ANDA 17 sections
BETASEPT HUMAN PRESCRIPTION DRUG LABEL 1 0116-0200 SOLUTION 0.04 mg TOPICAL NDA 14 sections
Antiseptic Skin Cleanser HUMAN OTC DRUG LABEL 1 0116-0228 LIQUID 4 mg TOPICAL NDA 15 sections
Antiseptic Skin Cleanser HUMAN OTC DRUG LABEL 1 0116-0237 LIQUID 4 mg TOPICAL NDA 14 sections
Denti-Care Denti-RinseChlorhexidine Gluconate Oral Rinse HUMAN PRESCRIPTION DRUG LABEL 1 0116-0244 LIQUID 1.20 mg DENTAL ANDA 13 sections
Chlorhexidine Gluconate HUMAN PRESCRIPTION DRUG LABEL 1 0116-0301 RINSE 1.20 mg ORAL ANDA 19 sections
Antiseptic Skin Cleanser HUMAN OTC DRUG LABEL 1 0116-0401 LIQUID 4 mg TOPICAL NDA 14 sections
ANTISEPTIC SKIN CLEANSER HUMAN PRESCRIPTION DRUG LABEL 1 0116-0407 SOLUTION 4 g TOPICAL NDA 15 sections
BD E-Z Scrub HUMAN OTC DRUG LABEL 1 0116-0505 SOLUTION 40 g TOPICAL NDA 14 sections
BD E-Z Scrub HUMAN OTC DRUG LABEL 1 0116-0506 SOLUTION 20 mg TOPICAL NDA 14 sections
Peridex HUMAN PRESCRIPTION DRUG LABEL 1 0116-0620 RINSE 1.20 mg ORAL NDA 21 sections
Peridex HUMAN PRESCRIPTION DRUG LABEL 1 0116-0620 RINSE 1.20 mg ORAL NDA 21 sections
Scrub CareExidine-2 CHG HUMAN OTC DRUG LABEL 1 0116-0722 SOLUTION 2 mg TOPICAL NDA 14 sections
Antiseptic Skin Cleanser HUMAN OTC DRUG LABEL 1 0116-0767 LIQUID 4 g TOPICAL NDA 13 sections
Antiseptic Skin Cleanser HUMAN OTC DRUG LABEL 1 0116-0767 LIQUID 4 g TOPICAL NDA 13 sections
NUPRO Chlorhexidine Gluconate HUMAN PRESCRIPTION DRUG LABEL 1 0116-0800 RINSE 1.20 mg ORAL ANDA 20 sections
CliniClean HUMAN OTC DRUG LABEL 1 0116-0901 SOLUTION 4 g TOPICAL NDA 14 sections
CliniClean HUMAN OTC DRUG LABEL 1 0116-0901 SOLUTION 4 g TOPICAL NDA 14 sections
CliniClean HUMAN OTC DRUG LABEL 1 0116-0901 SOLUTION 4 g TOPICAL NDA 14 sections
DYNA-HEX2 HUMAN OTC DRUG LABEL 1 0116-1021 LIQUID 2 g TOPICAL NDA 13 sections