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

Stem definitionDrug idCAS RN
antibiotics, produced by Streptomyces strains 668 81103-11-9

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • clarithromycin
  • 6-O-Methylerythromycin A
  • biaxin
  • clamicin
  • clathromycin
A semisynthetic macrolide antibiotic derived from ERYTHROMYCIN that is active against a variety of microorganisms. It can inhibit PROTEIN SYNTHESIS in BACTERIA by reversibly binding to the 50S ribosomal subunits. This inhibits the translocation of aminoacyl transfer-RNA and prevents peptide chain elongation.
  • Molecular weight: 747.96
  • Formula: C38H69NO13
  • CLOGP: 2.39
  • LIPINSKI: 2
  • HAC: 14
  • HDO: 4
  • TPSA: 182.91
  • ALOGS: -3.54
  • ROTB: 8
  • Status: OFP
    • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
0.50 g O
1 g P

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 3 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 2 mg/mL Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 35 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 11.14 µM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 55 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution) 1.50 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 7.30 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.23 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 2.80 hours Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
Oct. 31, 1991 FDA ABBVIE

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
Drug interaction 973.00 11.40 1085 53346 228046 63206545
Macular degeneration 510.20 11.40 296 54135 24080 63410511
Drug hypersensitivity 401.17 11.40 846 53585 309841 63124750
Abortion spontaneous 340.10 11.40 299 54132 46896 63387695
Erythema multiforme 182.76 11.40 112 54319 10057 63424534
Dysgeusia 171.70 11.40 206 54225 46504 63388087
Chronic sinusitis 165.91 11.40 115 54316 12728 63421863
Paraesthesia oral 161.13 11.40 133 54298 19123 63415468
Labelled drug-drug interaction medication error 159.21 11.40 114 54317 13285 63421306
Swollen tongue 155.84 11.40 170 54261 34630 63399961
Pemphigus 142.85 11.40 3 54428 183723 63250868
Drug eruption 131.66 11.40 142 54289 28552 63406039
Arthropathy 124.43 11.40 25 54406 234767 63199824
Joint swelling 124.18 11.40 63 54368 327603 63106988
Alopecia 123.35 11.40 68 54363 337468 63097123
Systemic lupus erythematosus 122.32 11.40 17 54414 208901 63225690
Hand deformity 112.11 11.40 6 54425 159451 63275140
Completed suicide 110.84 11.40 3 54428 145670 63288921
Death 110.78 11.40 95 54336 374286 63060305
Pain 110.31 11.40 301 54130 740327 62694264
Lip swelling 102.84 11.40 130 54301 30933 63403658
Angioedema 102.74 11.40 163 54268 47802 63386789
Fatigue 102.52 11.40 404 54027 887624 62546967
Rheumatoid arthritis 101.96 11.40 45 54386 253774 63180817
Loss of employment 101.96 11.40 46 54385 2198 63432393
Female genital tract fistula 100.72 11.40 69 54362 7490 63427101
Swelling face 99.65 11.40 188 54243 63287 63371304
Glossodynia 99.13 11.40 17 54414 178859 63255732
Synovitis 98.81 11.40 20 54411 186898 63247693
Erythema 98.58 11.40 353 54078 175398 63259193
Rhabdomyolysis 95.02 11.40 150 54281 43801 63390790
Sputum increased 91.81 11.40 44 54387 2415 63432176
Mania 90.31 11.40 79 54352 12288 63422303
Wound 87.27 11.40 17 54414 163246 63271345
Electrocardiogram QT prolonged 86.93 11.40 171 54260 59359 63375232
Malaise 82.97 11.40 625 53806 415329 63019262
Drug resistance 82.37 11.40 100 54331 22833 63411758
Sinusitis fungal 78.35 11.40 36 54395 1795 63432796
Salpingo-oophorectomy unilateral 77.55 11.40 29 54402 852 63433739
Rash maculo-papular 74.74 11.40 113 54318 31783 63402808
Psychotic disorder 73.31 11.40 100 54331 25612 63408979
Embolism venous 73.19 11.40 41 54390 3113 63431478
Enterocolitis haemorrhagic 72.85 11.40 32 54399 1434 63433157
Stevens-Johnson syndrome 72.60 11.40 98 54333 24852 63409739
Myositis 65.27 11.40 58 54373 9208 63425383
Tongue discolouration 65.27 11.40 38 54393 3105 63431486
Palpitations 64.45 11.40 228 54203 112542 63322049
Long QT syndrome 63.77 11.40 38 54393 3241 63431350
Paranoia 62.91 11.40 63 54368 11616 63422975
Hepatic enzyme increased 62.66 11.40 49 54382 202279 63232312
Peripheral swelling 61.32 11.40 83 54348 265859 63168732
Paradoxical drug reaction 60.34 11.40 40 54391 4112 63430479
Duodenal ulcer perforation 59.10 11.40 4 54427 87205 63347386
Procedural pain 58.66 11.40 82 54349 21487 63413104
Pericarditis 58.29 11.40 20 54411 131559 63303032
Tongue oedema 56.74 11.40 40 54391 4546 63430045
Vaginal flatulence 55.95 11.40 35 54396 3258 63431333
Urticaria 55.59 11.40 285 54146 165517 63269074
Psoriatic arthropathy 54.59 11.40 7 54424 91513 63343078
Toxic epidermal necrolysis 54.11 11.40 86 54345 25248 63409343
Agitation 54.07 11.40 142 54289 59615 63374976
Discomfort 53.79 11.40 39 54392 167335 63267256
Hallucination, visual 53.43 11.40 74 54357 19224 63415367
Musculoskeletal stiffness 53.12 11.40 48 54383 184570 63250021
Respiratory symptom 52.93 11.40 34 54397 3313 63431278
Treatment failure 52.37 11.40 56 54375 198987 63235604
Hallucination 51.38 11.40 132 54299 54685 63379906
Acute psychosis 51.04 11.40 30 54401 2495 63432096
Hepatic function abnormal 50.98 11.40 104 54327 37038 63397553
Lip oedema 50.35 11.40 35 54396 3889 63430702
Ototoxicity 49.73 11.40 24 54407 1338 63433253
Fall 49.25 11.40 172 54259 392162 63042429
Pathogen resistance 48.99 11.40 42 54389 6356 63428235
Pneumonia mycoplasmal 48.60 11.40 21 54410 904 63433687
Immunosuppressant drug level increased 47.97 11.40 33 54398 3605 63430986
Blood cholesterol increased 47.75 11.40 11 54420 94021 63340570
Potentiating drug interaction 47.06 11.40 35 54396 4321 63430270
Psoriasis 46.56 11.40 9 54422 86948 63347643
Face oedema 46.49 11.40 71 54360 20141 63414450
Torsade de pointes 45.97 11.40 57 54374 13294 63421297
Nightmare 44.96 11.40 68 54363 19126 63415465
Acute kidney injury 44.32 11.40 381 54050 263034 63171557
Eosinophilic pneumonia 43.98 11.40 26 54405 2185 63432406
Jaundice 43.87 11.40 85 54346 29166 63405425
Irritable bowel syndrome 43.14 11.40 9 54422 82403 63352188
Product dose omission issue 42.90 11.40 85 54346 234228 63200363
Folliculitis 42.87 11.40 5 54426 70312 63364279
Oral candidiasis 42.77 11.40 73 54358 22725 63411866
Dyspnoea 42.23 11.40 798 53633 660515 62774076
International normalised ratio increased 41.67 11.40 110 54321 46315 63388276
Muscle injury 41.49 11.40 4 54427 65341 63369250
Hepatic ischaemia 41.31 11.40 17 54414 647 63433944
Hypoglycaemia 41.01 11.40 129 54302 59936 63374655
Nasal polyps 40.95 11.40 37 54394 6002 63428589
Proctitis 40.21 11.40 35 54396 5406 63429185
Hallucination, auditory 39.81 11.40 52 54379 12772 63421819
Mobility decreased 39.22 11.40 28 54403 121131 63313460
Eczema 39.20 11.40 86 54345 32205 63402386
Pharyngeal swelling 39.09 11.40 37 54394 6367 63428224
Diastolic dysfunction 38.77 11.40 37 54394 6434 63428157
Ill-defined disorder 38.75 11.40 11 54420 81744 63352847
General physical health deterioration 38.67 11.40 71 54360 201331 63233260
Arthralgia 38.25 11.40 309 54122 569401 62865190
Purpura 38.23 11.40 48 54383 11337 63423254
Vomiting 38.02 11.40 682 53749 558935 62875656
Hepatic steatosis 37.65 11.40 79 54352 28690 63405901
Intentional product use issue 37.08 11.40 33 54398 127859 63306732
Rash erythematous 36.41 11.40 99 54332 42411 63392180
Atypical mycobacterial infection 36.03 11.40 18 54413 1082 63433509
Hallucinations, mixed 35.56 11.40 31 54400 4798 63429793
Impaired healing 35.48 11.40 22 54409 102520 63332071
Knee arthroplasty 35.27 11.40 3 54428 54203 63380388
Toxic skin eruption 35.06 11.40 49 54382 12836 63421755
Mycobacterium abscessus infection 34.64 11.40 15 54416 649 63433942
Injection site pain 33.59 11.40 37 54394 129763 63304828
Deafness 33.02 11.40 57 54374 17900 63416691
Acinetobacter infection 32.50 11.40 19 54412 1564 63433027
Ventricular tachycardia 32.36 11.40 60 54371 19919 63414672
Pruritus 32.20 11.40 461 53970 360992 63073599
Hepatocellular injury 32.19 11.40 72 54359 27309 63407282
Adverse event 32.19 11.40 9 54422 67550 63367041
Pyrexia 32.14 11.40 574 53857 469904 62964687
Infection 31.82 11.40 96 54335 229077 63205514
Brief psychotic disorder with marked stressors 31.79 11.40 8 54423 57 63434534
Cough 31.74 11.40 387 54044 292356 63142235
Drug level increased 31.60 11.40 64 54367 22672 63411919
Mycobacterium chelonae infection 31.49 11.40 13 54418 499 63434092
Weber tuning fork test abnormal 31.42 11.40 9 54422 110 63434481
Muscle necrosis 31.33 11.40 14 54417 654 63433937
Pharyngeal oedema 31.27 11.40 48 54383 13673 63420918
Staphylococcal scalded skin syndrome 30.57 11.40 9 54422 122 63434469
Gait disturbance 30.55 11.40 70 54361 183108 63251483
Abdominal pain 30.55 11.40 385 54046 293071 63141520
Tinnitus 30.54 11.40 83 54348 35545 63399046
Pressure of speech 30.21 11.40 14 54417 712 63433879
Radiculopathy 30.03 11.40 37 54394 8574 63426017
Gastric disorder 30.00 11.40 85 54346 37284 63397307
Bipolar I disorder 29.32 11.40 19 54412 1880 63432711
Pseudomembranous colitis 29.22 11.40 23 54408 3089 63431502
Infusion related reaction 29.20 11.40 110 54321 245411 63189180
Drug monitoring procedure not performed 29.13 11.40 13 54418 605 63433986
Dermatitis allergic 29.07 11.40 49 54382 15099 63419492
Abdominal pain upper 28.83 11.40 287 54144 206157 63228434
Swelling 28.63 11.40 130 54301 275248 63159343
Wheezing 28.38 11.40 159 54272 95436 63339155
Stenotrophomonas infection 28.19 11.40 19 54412 2008 63432583
Labile blood pressure 27.86 11.40 18 54413 1771 63432820
Muscle relaxant therapy 27.80 11.40 9 54422 170 63434421
Throat tightness 27.66 11.40 64 54367 24823 63409768
Hip arthroplasty 27.57 11.40 4 54427 47642 63386949
Euphoric mood 27.50 11.40 27 54404 4860 63429731
Drug-induced liver injury 27.10 11.40 86 54345 40136 63394455
Rash macular 26.98 11.40 61 54370 23303 63411288
Henoch-Schonlein purpura 26.66 11.40 15 54416 1148 63433443
Vaginal discharge 26.56 11.40 36 54395 9162 63425429
Nausea 26.33 11.40 936 53495 853535 62581056
Blood creatine phosphokinase increased 26.19 11.40 71 54360 30359 63404232
Pharyngeal erythema 26.15 11.40 17 54414 1691 63432900
Pneumococcal infection 26.12 11.40 11 54420 444 63434147
Disseminated mycobacterium avium complex infection 26.00 11.40 8 54423 127 63434464
Emphysema 25.97 11.40 39 54392 10899 63423692
Abnormal dreams 25.69 11.40 38 54393 10478 63424113
Tangentiality 25.33 11.40 6 54425 32 63434559
Myopathy 25.30 11.40 39 54392 11152 63423439
Candida infection 25.26 11.40 67 54364 28284 63406307
Mycobacterium avium complex infection 25.14 11.40 21 54410 3067 63431524
Hepatitis fulminant 25.03 11.40 22 54409 3442 63431149
Serum sickness-like reaction 24.92 11.40 11 54420 499 63434092
Haemostasis 24.85 11.40 9 54422 241 63434350
Meningitis streptococcal 24.81 11.40 8 54423 149 63434442
Red blood cell sedimentation rate increased 24.74 11.40 4 54427 43978 63390613
Lymphocyte stimulation test positive 24.73 11.40 11 54420 508 63434083
Diverticulum 24.64 11.40 40 54391 11951 63422640
Malignant neoplasm progression 24.02 11.40 21 54410 82100 63352491
Asthma 23.82 11.40 189 54242 127372 63307219
Disease recurrence 23.72 11.40 65 54366 27965 63406626
Weight increased 23.72 11.40 129 54302 260663 63173928
Contraindicated product administered 23.67 11.40 101 54330 217547 63217044
Product use issue 23.57 11.40 103 54328 220417 63214174
Lipoedema 23.31 11.40 9 54422 289 63434302
Trichoglossia 23.28 11.40 9 54422 290 63434301
Drug intolerance 23.23 11.40 162 54269 308499 63126092
Arthritis 23.01 11.40 40 54391 115881 63318710
Therapeutic product effect decreased 22.67 11.40 87 54344 193100 63241491
Psychotic symptom 22.59 11.40 15 54416 1546 63433045
Dyspepsia 22.24 11.40 157 54274 102039 63332552
Oral mucosal blistering 22.23 11.40 26 54405 5707 63428884
Insomnia 22.21 11.40 282 54149 214970 63219621
Frequent bowel movements 22.15 11.40 56 54375 22966 63411625
Multiple sclerosis relapse 22.10 11.40 7 54424 48471 63386120
Oesophageal pain 21.86 11.40 21 54410 3680 63430911
Superinfection 21.79 11.40 18 54413 2589 63432002
Type 2 diabetes mellitus 21.68 11.40 14 54417 63854 63370737
Jarisch-Herxheimer reaction 21.26 11.40 9 54422 368 63434223
Agitation neonatal 21.24 11.40 10 54421 527 63434064
Deafness bilateral 21.22 11.40 14 54417 1428 63433163
Injection site erythema 21.19 11.40 24 54407 83150 63351441
Delusional perception 21.14 11.40 8 54423 243 63434348
Psychomotor hyperactivity 21.14 11.40 35 54396 10628 63423963
Hypovolaemia 21.11 11.40 35 54396 10638 63423953
Polyuria 21.06 11.40 31 54400 8511 63426080
Immune reconstitution inflammatory syndrome 20.99 11.40 26 54405 6058 63428533
Mouth swelling 20.94 11.40 23 54408 4717 63429874
Delusion of grandeur 20.90 11.40 8 54423 251 63434340
Cerebrovascular accident 20.79 11.40 38 54393 107986 63326605
Rash 20.45 11.40 627 53804 560244 62874347
Palatal oedema 20.43 11.40 10 54421 575 63434016
Diarrhoea 20.38 11.40 777 53654 714589 62720002
Anxiety 20.36 11.40 280 54151 217261 63217330
Eosinophilic pneumonia acute 20.21 11.40 9 54422 417 63434174
Tricuspid valve incompetence 20.13 11.40 41 54390 14580 63420011
Cardioactive drug level increased 20.10 11.40 16 54415 2184 63432407
Mouth ulceration 19.96 11.40 68 54363 32916 63401675
Pain in extremity 19.86 11.40 185 54246 331301 63103290
Uveitis 19.46 11.40 37 54394 12516 63422075
Prescribed overdose 19.45 11.40 3 54428 34150 63400441
Depersonalisation/derealisation disorder 19.41 11.40 13 54418 1359 63433232
Helicobacter infection 19.36 11.40 31 54400 92754 63341837
Cognitive disorder 19.27 11.40 12 54419 55803 63378788
Tongue exfoliation 19.23 11.40 6 54425 100 63434491
Disinhibition 19.20 11.40 11 54420 872 63433719
Morganella infection 19.13 11.40 10 54421 661 63433930
Agranulocytosis 19.04 11.40 56 54375 25078 63409513
Hyperleukocytosis 18.92 11.40 10 54421 676 63433915
Therapeutic response decreased 18.90 11.40 15 54416 61510 63373081
Mucosal discolouration 18.69 11.40 9 54422 499 63434092
Circulatory collapse 18.69 11.40 51 54380 21887 63412704
Hysterectomy 18.59 11.40 31 54400 9468 63425123
Liver disorder 18.46 11.40 93 54338 53594 63380997
Gastroenteritis eosinophilic 18.45 11.40 6 54425 115 63434476
Prothrombin time ratio decreased 18.20 11.40 9 54422 529 63434062
Erythrosis 18.10 11.40 5 54426 53 63434538
Repetitive speech 17.93 11.40 8 54423 372 63434219
Oculomucocutaneous syndrome 17.89 11.40 6 54425 127 63434464
Excessive eye blinking 17.80 11.40 12 54419 1268 63433323
Vertebral artery occlusion 17.72 11.40 6 54425 131 63434460
Lip discolouration 17.39 11.40 9 54422 583 63434008
Blood pressure fluctuation 17.36 11.40 9 54422 46308 63388283
Memory impairment 17.24 11.40 40 54391 104218 63330373
Hypoaesthesia 17.18 11.40 80 54351 168313 63266278
Photosensitivity reaction 17.15 11.40 39 54392 14955 63419636
No adverse event 17.14 11.40 7 54424 41398 63393193
Developmental hip dysplasia 17.05 11.40 12 54419 1360 63433231
Urinary tract infection 17.04 11.40 145 54286 264539 63170052
Acute hepatic failure 17.03 11.40 44 54387 18283 63416308
Tongue coated 17.03 11.40 12 54419 1363 63433228
Chest discomfort 16.88 11.40 156 54275 109813 63324778
Febrile neutropenia 16.87 11.40 49 54382 118400 63316191
Coagulopathy 16.75 11.40 47 54384 20497 63414094
Lymphoedema 16.35 11.40 33 54398 11659 63422932
Pharyngitis 16.34 11.40 46 54385 20097 63414494
Obesity 16.24 11.40 3 54428 29949 63404642
Iridocyclitis 16.22 11.40 15 54416 2507 63432084
Upper respiratory tract inflammation 16.21 11.40 15 54416 2508 63432083
Neoplasm malignant 16.17 11.40 3 54428 29858 63404733
Blood catecholamines abnormal 16.11 11.40 3 54428 3 63434588
Iris atrophy 16.10 11.40 5 54426 82 63434509
Contusion 16.07 11.40 70 54361 149974 63284617
Bronchial obstruction 16.04 11.40 12 54419 1495 63433096
Renal impairment 15.99 11.40 130 54301 88225 63346366
Patient isolation 15.96 11.40 4 54427 28 63434563
Systemic toxicity 15.93 11.40 5 54426 85 63434506
Keratitis 15.80 11.40 17 54414 3405 63431186
Allergy to animal 15.72 11.40 11 54420 1235 63433356
Hypomania 15.65 11.40 23 54408 6307 63428284
Pregnancy 15.62 11.40 6 54425 36830 63397761
Iron deficiency anaemia 15.62 11.40 45 54386 19924 63414667
Rales 15.61 11.40 34 54397 12663 63421928
Functional residual capacity increased 15.57 11.40 5 54426 92 63434499
Glossitis 15.46 11.40 16 54415 3066 63431525
Gingival swelling 15.43 11.40 19 54412 4399 63430192
Drug ineffective for unapproved indication 15.43 11.40 64 54367 33999 63400592
Dysphonia 15.34 11.40 81 54350 47533 63387058
Hiatus hernia 15.31 11.40 47 54384 21547 63413044
Gynaecological chlamydia infection 15.27 11.40 4 54427 34 63434557
Acute generalised exanthematous pustulosis 15.13 11.40 31 54400 11068 63423523
Tongue dry 14.99 11.40 10 54421 1039 63433552
Poor feeding infant 14.98 11.40 7 54424 363 63434228
Optic neuropathy 14.87 11.40 13 54418 2019 63432572
Affective disorder 14.71 11.40 22 54409 6124 63428467
Inhibitory drug interaction 14.67 11.40 15 54416 2834 63431757
Foot deformity 14.66 11.40 3 54428 27850 63406741
Petechiae 14.64 11.40 35 54396 13862 63420729
Neck pain 14.61 11.40 23 54408 69295 63365296
Hospitalisation 14.59 11.40 32 54399 85049 63349542
Off label use 14.56 11.40 454 53977 674008 62760583
Labelled drug-drug interaction issue 14.55 11.40 10 54421 1091 63433500
COVID-19 treatment 14.44 11.40 5 54426 117 63434474
Chromaturia 14.38 11.40 39 54392 16678 63417913
Dermatitis exfoliative generalised 14.32 11.40 17 54414 3790 63430801
Mycobacterial infection 14.26 11.40 12 54419 1771 63432820
Skin reaction 14.16 11.40 36 54395 14813 63419778
Oral discomfort 14.11 11.40 27 54404 9174 63425417
Injection site swelling 14.11 11.40 12 54419 47560 63387031
Injection site pruritus 13.86 11.40 11 54420 45105 63389486
Status asthmaticus 13.84 11.40 9 54422 895 63433696
Abdominal tenderness 13.83 11.40 25 54406 8141 63426450
Neoplasm progression 13.77 11.40 7 54424 36421 63398170
Chemotherapeutic drug level increased 13.73 11.40 5 54426 136 63434455
Obstructive airways disorder 13.71 11.40 44 54387 20655 63413936
Abnormal behaviour 13.70 11.40 45 54386 21381 63413210
Oscillopsia 13.66 11.40 5 54426 138 63434453
Genital pain 13.66 11.40 7 54424 444 63434147
Stomatitis 13.51 11.40 67 54364 138658 63295933
Intentional overdose 13.46 11.40 27 54404 74125 63360466
Scab 13.44 11.40 24 54407 7739 63426852
Surgery 13.43 11.40 7 54424 35905 63398686
Breast cancer 13.40 11.40 13 54418 48370 63386221
Beta 2 microglobulin increased 13.37 11.40 5 54426 147 63434444
Loss of personal independence in daily activities 13.31 11.40 41 54390 97249 63337342
Musculoskeletal pain 13.26 11.40 38 54393 92239 63342352
Femur fracture 13.05 11.40 10 54421 41746 63392845
Haemoptysis 13.03 11.40 54 54377 28672 63405919
Gastrointestinal disorder 13.00 11.40 63 54368 131176 63303415
Oedema mouth 12.96 11.40 13 54418 2400 63432191
Tooth disorder 12.95 11.40 4 54427 28153 63406438
Sputum discoloured 12.94 11.40 37 54394 16310 63418281
Quadriparesis 12.92 11.40 12 54419 2017 63432574
Therapy cessation 12.85 11.40 5 54426 30452 63404139
Otitis media fungal 12.83 11.40 3 54428 15 63434576
Nosocomial infection 12.57 11.40 11 54420 1710 63432881
Kounis syndrome 12.53 11.40 11 54420 1719 63432872
Vulval haemorrhage 12.51 11.40 3 54428 17 63434574
Mucocutaneous rash 12.51 11.40 3 54428 17 63434574
Road traffic accident 12.47 11.40 8 54423 36624 63397967
Blood glucose increased 12.40 11.40 34 54397 83722 63350869
Anterograde amnesia 12.39 11.40 7 54424 540 63434051
Nephropathy toxic 12.37 11.40 26 54405 9453 63425138
Carcinoembryonic antigen increased 12.33 11.40 11 54420 1754 63432837
Bradycardia 12.32 11.40 106 54325 73121 63361470
Fistula discharge 12.30 11.40 9 54422 1084 63433507
Liver function test abnormal 12.27 11.40 77 54354 48104 63386487
Flushing 12.26 11.40 29 54402 75058 63359533
Acute respiratory distress syndrome 12.09 11.40 46 54385 23488 63411103
Enterococcal infection 12.00 11.40 23 54408 7825 63426766
Product quality issue 11.98 11.40 8 54423 35857 63398734
Lower limb fracture 11.96 11.40 3 54428 24218 63410373
Gastroenteritis clostridial 11.88 11.40 7 54424 585 63434006
Sleep apnoea syndrome 11.86 11.40 53 54378 29080 63405511
Oesophageal spasm 11.84 11.40 14 54417 3109 63431482
Suspiciousness 11.82 11.40 6 54425 373 63434218
Psychotic behaviour 11.79 11.40 7 54424 593 63433998
Injection site reaction 11.79 11.40 20 54411 58504 63376087
Muscle spasms 11.70 11.40 82 54349 156068 63278523
Ventricular fibrillation 11.55 11.40 29 54402 11838 63422753
Metastases to liver 11.54 11.40 3 54428 23636 63410955
Calculus bladder 11.50 11.40 7 54424 620 63433971
Dysbiosis 11.43 11.40 8 54423 898 63433693
Foetal malnutrition 11.42 11.40 4 54427 97 63434494
Bursitis 11.41 11.40 9 54422 37032 63397559

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 interaction 807.07 11.63 1103 36988 224843 34693997
Labelled drug-drug interaction medication error 262.00 11.63 177 37914 14762 34904078
Immunosuppressant drug level increased 195.06 11.63 106 37985 5949 34912891
Death 164.76 11.63 117 37974 397932 34520908
Rhabdomyolysis 122.06 11.63 245 37846 67918 34850922
Drug level increased 113.44 11.63 130 37961 21966 34896874
Paradoxical drug reaction 100.58 11.63 56 38035 3295 34915545
Drug resistance 84.84 11.63 122 37969 25805 34893035
Oesophageal perforation 81.40 11.63 35 38056 1164 34917676
Lip swelling 79.83 11.63 93 37998 15987 34902853
Atypical mycobacterial infection 77.29 11.63 31 38060 862 34917978
Erythema 75.99 11.63 241 37850 88539 34830301
Immune reconstitution inflammatory syndrome 75.11 11.63 68 38023 8691 34910149
Soft tissue mass 73.33 11.63 31 38060 988 34917852
Multimorbidity 72.29 11.63 30 38061 912 34917928
Inflammatory marker increased 70.53 11.63 52 38039 4976 34913864
Fatigue 70.45 11.63 191 37900 370462 34548378
Electrocardiogram QT prolonged 69.46 11.63 144 37947 40808 34878032
Mucocutaneous disorder 69.08 11.63 18 38073 114 34918726
Acute kidney injury 66.29 11.63 562 37529 304426 34614414
Drug abuse 65.50 11.63 14 38077 99082 34819758
Completed suicide 64.61 11.63 14 38077 98154 34820686
Lip oedema 63.33 11.63 38 38053 2575 34916265
Hypocoagulable state 62.21 11.63 27 38064 919 34917921
Contraindicated product prescribed 56.15 11.63 20 38071 397 34918443
Ototoxicity 54.72 11.63 31 38060 1886 34916954
Superinfection 54.32 11.63 34 38057 2485 34916355
Nephropathy toxic 51.44 11.63 66 38025 12522 34906318
Pyrexia 50.85 11.63 570 37521 332443 34586397
Torsade de pointes 50.42 11.63 50 38041 7159 34911681
Hepatic function abnormal 47.03 11.63 130 37961 44233 34874607
Off label use 46.50 11.63 268 37823 419256 34499584
Stevens-Johnson syndrome 45.97 11.63 77 38014 18562 34900278
Transplant failure 43.76 11.63 34 38057 3519 34915321
Potentiating drug interaction 43.38 11.63 39 38052 4938 34913902
Acute psychosis 42.60 11.63 26 38065 1817 34917023
Hospitalisation 42.03 11.63 6 38085 56896 34861944
Myocardial infarction 41.97 11.63 42 38049 121043 34797797
Mycobacterial infection 41.29 11.63 28 38063 2346 34916494
Oropharyngeal blistering 40.44 11.63 13 38078 186 34918654
Febrile neutropenia 40.39 11.63 54 38037 136795 34782045
Lung consolidation 39.36 11.63 40 38051 5896 34912944
Fixed eruption 39.34 11.63 24 38067 1676 34917164
Pathogen resistance 39.19 11.63 50 38041 9432 34909408
Drug-induced liver injury 38.31 11.63 92 37999 28740 34890100
Malaise 37.91 11.63 338 37753 185487 34733353
Phalangeal hypoplasia 37.51 11.63 10 38081 70 34918770
Enterocolitis haemorrhagic 36.71 11.63 19 38072 964 34917876
Liver disorder 36.27 11.63 98 37993 32899 34885941
Product dose omission issue 35.56 11.63 47 38044 119664 34799176
Haemoptysis 35.54 11.63 101 37990 34905 34883935
Cerebrovascular accident 34.79 11.63 25 38066 84786 34834054
Cardioactive drug level increased 34.10 11.63 22 38069 1695 34917145
Clostridium difficile infection 33.85 11.63 68 38023 18830 34900010
Productive cough 33.55 11.63 104 37987 37709 34881131
Tachycardia foetal 33.51 11.63 13 38078 330 34918510
Drug reaction with eosinophilia and systemic symptoms 33.28 11.63 95 37996 32917 34885923
Pseudomembranous colitis 32.84 11.63 26 38065 2765 34916075
Long QT syndrome 32.74 11.63 26 38065 2777 34916063
Helicobacter gastritis 32.64 11.63 19 38072 1217 34917623
Inhibitory drug interaction 31.98 11.63 21 38070 1667 34917173
Face oedema 31.69 11.63 50 38041 11466 34907374
Mania 31.46 11.63 45 38046 9466 34909374
Pain 31.35 11.63 116 37975 204559 34714281
Mycobacterium chelonae infection 31.15 11.63 16 38075 799 34918041
Mycobacterium avium complex infection 30.86 11.63 24 38067 2487 34916353
International normalised ratio increased 30.48 11.63 117 37974 47210 34871630
Tongue discolouration 30.30 11.63 18 38073 1197 34917643
Erythema multiforme 30.20 11.63 42 38049 8607 34910233
Acid fast bacilli infection 30.07 11.63 9 38082 100 34918740
Irregular breathing 29.73 11.63 10 38081 166 34918674
Rash maculovesicular 29.53 11.63 7 38084 28 34918812
Liver function test abnormal 29.00 11.63 87 38004 30987 34887853
Hypoglycaemia 28.81 11.63 127 37964 54513 34864327
Prostate cancer 27.44 11.63 5 38086 39644 34879196
Myositis 27.31 11.63 48 38043 12022 34906818
Renal ischaemia 27.18 11.63 13 38078 556 34918284
Tongue oedema 27.14 11.63 24 38067 2973 34915867
Drug eruption 26.98 11.63 64 38027 19834 34899006
Pulmonary cavitation 26.44 11.63 15 38076 915 34917925
Diffuse alveolar damage 26.04 11.63 21 38070 2293 34916547
Hallucination 25.87 11.63 118 37973 51380 34867460
Pulmonary physical examination abnormal 25.72 11.63 6 38085 22 34918818
Dysgeusia 25.50 11.63 75 38016 26422 34892418
Hypertension 25.28 11.63 71 38020 136372 34782468
Lip erythema 25.12 11.63 7 38084 59 34918781
Oesophageal carcinoma 25.05 11.63 40 38051 9264 34909576
Myopathy 24.92 11.63 45 38046 11509 34907331
Renal impairment 24.70 11.63 182 37909 94331 34824509
Deep vein thrombosis 24.52 11.63 21 38070 65227 34853613
Mononucleosis syndrome 24.52 11.63 7 38084 65 34918775
Swollen tongue 24.33 11.63 51 38040 14554 34904286
Nasal mucosal disorder 24.29 11.63 8 38083 124 34918716
Deafness neurosensory 24.05 11.63 22 38069 2849 34915991
Urticaria papular 23.96 11.63 7 38084 71 34918769
Injection site phlebitis 23.74 11.63 6 38085 33 34918807
Neuropsychiatric lupus 23.63 11.63 5 38086 10 34918830
Primary hypoparathyroidism 23.59 11.63 6 38085 34 34918806
Hallucinations, mixed 23.29 11.63 21 38070 2668 34916172
Rash macular 22.75 11.63 46 38045 12796 34906044
Lower respiratory tract infection 22.70 11.63 81 38010 31556 34887284
Substance-induced mood disorder 22.46 11.63 7 38084 90 34918750
Skin exfoliation 22.10 11.63 73 38018 27359 34891481
Urticaria 21.68 11.63 129 37962 62248 34856592
Neuropsychiatric symptoms 21.55 11.63 13 38078 889 34917951
Cardiac disorder 21.54 11.63 10 38081 43116 34875724
Coronary artery disease 21.48 11.63 13 38078 48292 34870548
Rash maculo-papular 21.41 11.63 74 38017 28377 34890463
Infusion related reaction 21.28 11.63 16 38075 53041 34865799
Congenital foot malformation 20.82 11.63 10 38081 432 34918408
Toxic epidermal necrolysis 20.57 11.63 61 38030 21585 34897255
Rheumatoid arthritis 20.48 11.63 8 38083 38230 34880610
Asthenia 20.47 11.63 170 37921 245081 34673759
HIV associated nephropathy 20.26 11.63 9 38082 324 34918516
Vanishing bile duct syndrome 20.11 11.63 13 38078 1005 34917835
Neuromyopathy 19.92 11.63 13 38078 1021 34917819
Contraindicated product administered 19.90 11.63 60 38031 21421 34897419
Circumoral oedema 19.86 11.63 6 38085 69 34918771
Purpura 19.55 11.63 38 38053 10273 34908567
Helicobacter test positive 19.35 11.63 12 38079 863 34917977
Malignant neoplasm progression 19.28 11.63 42 38049 88004 34830836
Cardiothoracic ratio increased 19.28 11.63 5 38086 31 34918809
Foetal distress syndrome 19.19 11.63 13 38078 1087 34917753
Weight increased 19.07 11.63 46 38045 92987 34825853
Bronchopulmonary aspergillosis 18.64 11.63 46 38045 14613 34904227
Cross sensitivity reaction 18.59 11.63 14 38077 1383 34917457
Wrong technique in product usage process 18.51 11.63 8 38083 35978 34882862
Blood pressure increased 18.50 11.63 43 38048 88059 34830781
Anamnestic reaction 18.40 11.63 5 38086 38 34918802
Urinary tract inflammation 18.37 11.63 7 38084 169 34918671
Acute myocardial infarction 18.18 11.63 19 38072 53700 34865140
Mononeuropathy 18.10 11.63 6 38085 95 34918745
Jarisch-Herxheimer reaction 18.07 11.63 10 38081 581 34918259
Penile erythema 18.00 11.63 7 38084 179 34918661
Sensitisation 17.93 11.63 7 38084 181 34918659
Blood pressure fluctuation 17.87 11.63 3 38088 25246 34893594
Helicobacter infection 17.82 11.63 17 38074 2320 34916520
Plateletcrit decreased 17.47 11.63 3 38088 0 34918840
Sitting disability 17.37 11.63 7 38084 197 34918643
Arthropathy 17.36 11.63 4 38087 26903 34891937
Fall 17.20 11.63 140 37951 202745 34716095
Atrial fibrillation 17.03 11.63 72 38019 122321 34796519
Rales 17.03 11.63 35 38056 9848 34908992
Anticonvulsant drug level increased 16.79 11.63 14 38077 1602 34917238
Oral mucosal blistering 16.76 11.63 15 38076 1887 34916953
Antineutrophil cytoplasmic antibody 16.68 11.63 4 38087 17 34918823
Pharyngeal erythema 16.42 11.63 10 38081 696 34918144
Dyspnoea 16.35 11.63 531 37560 376251 34542589
Photopsia 16.32 11.63 15 38076 1953 34916887
Mycobacterium abscessus infection 16.08 11.63 9 38082 535 34918305
Upper respiratory tract inflammation 15.86 11.63 14 38077 1730 34917110
Chloasma 15.83 11.63 4 38087 22 34918818
Pneumomediastinum 15.78 11.63 16 38075 2351 34916489
Hepatosplenomegaly 15.70 11.63 21 38070 4148 34914692
Swelling face 15.59 11.63 58 38033 23047 34895793
Bladder irrigation 15.59 11.63 5 38086 71 34918769
Cytokine release syndrome 15.58 11.63 3 38088 22874 34895966
Granulomatous dermatitis 15.51 11.63 7 38084 262 34918578
Rash erythematous 15.46 11.63 61 38030 24916 34893924
Pearly penile papules 15.39 11.63 3 38088 3 34918837
Diffuse panbronchiolitis 15.39 11.63 3 38088 3 34918837
Depersonalisation/derealisation disorder 15.34 11.63 9 38082 585 34918255
Abdominal wall haematoma 15.23 11.63 14 38077 1823 34917017
Acinetobacter bacteraemia 15.23 11.63 6 38085 159 34918681
Leukoplakia oral 15.21 11.63 5 38086 77 34918763
Drug hypersensitivity 15.12 11.63 144 37947 80385 34838455
Blood creatine phosphokinase increased 15.09 11.63 92 37999 44765 34874075
CD4/CD8 ratio decreased 15.01 11.63 4 38087 28 34918812
Chillblains 15.01 11.63 4 38087 28 34918812
School refusal 14.88 11.63 4 38087 29 34918811
Genital ulceration 14.88 11.63 8 38083 439 34918401
Repetitive speech 14.76 11.63 5 38086 85 34918755
Oculomucocutaneous syndrome 14.75 11.63 6 38085 173 34918667
Hepatomegaly 14.70 11.63 34 38057 10362 34908478
Urinary bladder rupture 14.54 11.63 5 38086 89 34918751
Jaundice 14.51 11.63 71 38020 31811 34887029
Rash 14.50 11.63 331 37760 222421 34696419
Intentional product misuse 14.48 11.63 17 38074 45594 34873246
Blood glucose increased 14.46 11.63 32 38059 66686 34852154
Deafness bilateral 14.46 11.63 11 38080 1103 34917737
Delusional disorder, persecutory type 14.43 11.63 7 38084 309 34918531
Urine alcohol test positive 14.32 11.63 4 38087 34 34918806
Paradoxical pain 14.18 11.63 3 38088 6 34918834
Bronchospasm 13.99 11.63 34 38057 10697 34908143
Clumsiness 13.98 11.63 13 38078 1719 34917121
Psoriasis 13.97 11.63 13 38078 38799 34880041
Shoulder deformity 13.87 11.63 3 38088 7 34918833
Nosocomial infection 13.81 11.63 11 38080 1180 34917660
Conjunctival hyperaemia 13.81 11.63 15 38076 2387 34916453
Agranulocytosis 13.81 11.63 57 38034 23764 34895076
Lymphocyte stimulation test positive 13.74 11.63 9 38082 711 34918129
Myocardial ischaemia 13.73 11.63 46 38045 17362 34901478
Pruritus 13.67 11.63 224 37867 141757 34777083
Respiratory tract infection bacterial 13.66 11.63 13 38078 1769 34917071
Overdose 13.65 11.63 52 38039 91007 34827833
Agitation 13.57 11.63 108 37983 57291 34861549
Hepatitis cholestatic 13.52 11.63 28 38063 7919 34910921
Necrotising panniculitis 13.48 11.63 4 38087 43 34918797
Induration 13.48 11.63 10 38081 965 34917875
Heart rate decreased 13.48 11.63 9 38082 31736 34887104
Blood urine 13.48 11.63 8 38083 531 34918309
Pleural effusion 13.46 11.63 142 37949 81404 34837436
Angioedema 13.43 11.63 78 38013 37296 34881544
Eosinophilic pneumonia acute 13.41 11.63 8 38083 536 34918304
Infusion site thrombosis 13.39 11.63 5 38086 114 34918726
Oral candidiasis 13.33 11.63 36 38055 12074 34906766
Hypo HDL cholesterolaemia 13.32 11.63 3 38088 9 34918831
Respiratory papilloma 13.32 11.63 3 38088 9 34918831
Constipation 13.28 11.63 91 38000 136891 34781949
Dehydration 13.27 11.63 85 38006 129884 34788956
Liver injury 13.26 11.63 41 38050 14837 34904003
Cardiomegaly 13.26 11.63 42 38049 15396 34903444
Toxic neuropathy 13.21 11.63 8 38083 551 34918289
Eosinophil count increased 13.20 11.63 29 38062 8543 34910297
Product use issue 13.15 11.63 31 38060 63185 34855655
Ataxia 13.12 11.63 39 38052 13814 34905026
Intentional overdose 13.10 11.63 17 38074 43657 34875183
Suicide attempt 13.05 11.63 14 38077 39102 34879738
Paraparesis 13.02 11.63 13 38078 1876 34916964
Speech disorder 13 11.63 59 38032 25627 34893213
Transient ischaemic attack 12.89 11.63 7 38084 27606 34891234
Cardiac failure congestive 12.84 11.63 47 38044 83223 34835617
Pneumonia bacterial 12.78 11.63 35 38056 11837 34907003
Back pain 12.77 11.63 79 38012 121710 34797130
Enanthema 12.43 11.63 7 38084 421 34918419
Panic attack 12.42 11.63 30 38061 9402 34909438
Chronic kidney disease 12.40 11.63 16 38075 41194 34877646
Delusion 12.38 11.63 36 38055 12599 34906241
Eosinophilic pneumonia 12.22 11.63 17 38074 3484 34915356
Erythema annulare 12.21 11.63 4 38087 61 34918779
Therapeutic product effect decreased 12.08 11.63 12 38079 34731 34884109
Biopsy liver abnormal 12.02 11.63 5 38086 153 34918687
Pneumonia mycoplasmal 11.99 11.63 8 38083 652 34918188
Hepatocellular injury 11.98 11.63 52 38039 22159 34896681
Tubulointerstitial nephritis 11.94 11.63 50 38041 20974 34897866
Intentional product use issue 11.92 11.63 30 38061 59786 34859054
Bronchostenosis 11.90 11.63 6 38085 288 34918552
Cytomegalovirus chorioretinitis 11.89 11.63 17 38074 3572 34915268
Arthritis 11.88 11.63 10 38081 31336 34887504
Neurosis 11.87 11.63 5 38086 158 34918682
Respiratory arrest 11.84 11.63 8 38083 28035 34890805
Adrenoleukodystrophy 11.81 11.63 4 38087 68 34918772
Panic reaction 11.77 11.63 11 38080 1464 34917376
Transaminases increased 11.68 11.63 59 38032 26764 34892076

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Drug interaction 1625.62 10.91 2058 79779 413125 79249426
Labelled drug-drug interaction medication error 417.52 10.91 292 81545 27358 79635193
Immunosuppressant drug level increased 222.74 10.91 130 81707 8897 79653654
Death 203.39 10.91 170 81667 566344 79096207
Completed suicide 201.02 10.91 13 81824 245754 79416797
Rhabdomyolysis 199.36 10.91 370 81467 102761 79559790
Drug hypersensitivity 181.09 10.91 695 81142 298221 79364330
Lip swelling 176.70 10.91 214 81623 40697 79621854
Dysgeusia 171.25 10.91 250 81587 56927 79605624
Erythema multiforme 162.46 10.91 139 81698 17512 79645039
Swollen tongue 158.87 10.91 207 81630 42363 79620188
Electrocardiogram QT prolonged 155.88 10.91 309 81528 90077 79572474
Chronic sinusitis 148.08 10.91 116 81721 12910 79649641
Paradoxical drug reaction 145.10 10.91 91 81746 7094 79655457
Erythema 142.43 10.91 528 81309 222762 79439789
Drug level increased 140.54 10.91 188 81649 39463 79623088
Fatigue 130.36 10.91 503 81334 929224 78733327
Mania 125.36 10.91 122 81715 18138 79644413
Drug resistance 122.68 10.91 182 81655 42031 79620520
Paraesthesia oral 120.79 10.91 126 81711 20345 79642206
Rheumatoid arthritis 117.60 10.91 34 81803 208436 79454115
Drug eruption 113.00 10.91 179 81658 43756 79618795
Arthropathy 111.37 10.91 23 81814 177088 79485463
Ototoxicity 110.59 10.91 58 81779 3216 79659335
Swelling face 109.24 10.91 232 81605 70980 79591571
Joint swelling 109.18 10.91 82 81755 288564 79373987
Acute kidney injury 107.95 10.91 905 80932 518499 79144052
Enterocolitis haemorrhagic 107.29 10.91 50 81787 2144 79660407
Pain 106.90 10.91 368 81469 703434 78959117
Malaise 103.08 10.91 856 80981 489013 79173538
Stevens-Johnson syndrome 98.56 10.91 158 81679 39008 79623543
Female genital tract fistula 96.98 10.91 66 81771 5909 79656642
Lip oedema 96.00 10.91 67 81770 6249 79656302
Long QT syndrome 92.45 10.91 64 81773 5891 79656660
Synovitis 91.86 10.91 21 81816 150713 79511838
Alopecia 91.03 10.91 63 81774 231292 79431259
Myositis 90.57 10.91 105 81732 19063 79643488
Potentiating drug interaction 88.47 10.91 73 81764 8746 79653805
Loss of employment 87.87 10.91 46 81791 2541 79660010
Angioedema 87.23 10.91 221 81616 75814 79586737
Acute psychosis 87.07 10.91 54 81783 4126 79658425
Hand deformity 86.41 10.91 5 81832 103914 79558637
Tongue discolouration 84.74 10.91 51 81786 3692 79658859
Immune reconstitution inflammatory syndrome 81.31 10.91 85 81752 13756 79648795
Rash maculo-papular 80.63 10.91 178 81659 55900 79606651
Pathogen resistance 80.56 10.91 86 81751 14256 79648295
Macular degeneration 78.53 10.91 76 81761 11220 79651331
Torsade de pointes 78.49 10.91 98 81739 19214 79643337
Atypical mycobacterial infection 76.88 10.91 37 81800 1706 79660845
Oesophageal perforation 74.34 10.91 35 81802 1536 79661015
Superinfection 72.17 10.91 51 81786 4851 79657700
Psychotic disorder 71.89 10.91 142 81695 41260 79621291
Drug-induced liver injury 71.53 10.91 188 81649 65929 79596622
Soft tissue mass 71.30 10.91 32 81805 1256 79661295
Palpitations 70.52 10.91 287 81550 126323 79536228
Systemic lupus erythematosus 69.71 10.91 19 81818 121130 79541421
Hallucination 67.87 10.91 218 81619 85527 79577024
Product dose omission issue 67.74 10.91 93 81744 247444 79415107
Salpingo-oophorectomy unilateral 67.05 10.91 27 81810 807 79661744
Toxic epidermal necrolysis 66.92 10.91 144 81693 44437 79618114
Pyrexia 66.26 10.91 1020 80817 677689 78984862
Hypoglycaemia 64.47 10.91 240 81597 101354 79561197
Drug abuse 64.38 10.91 44 81793 162647 79499904
Sinusitis fungal 63.39 10.91 36 81801 2338 79660213
Tongue oedema 63.36 10.91 55 81782 7062 79655489
Mucocutaneous disorder 63.13 10.91 17 81820 133 79662418
Nephropathy toxic 62.15 10.91 90 81747 20329 79642222
Urticaria 60.19 10.91 360 81477 184841 79477710
Hepatic function abnormal 59.80 10.91 188 81649 72919 79589632
Inflammatory marker increased 59.62 10.91 64 81773 10676 79651875
Agitation 59.51 10.91 231 81606 99484 79563067
Multimorbidity 58.83 10.91 29 81808 1410 79661141
Myopathy 58.79 10.91 88 81749 20475 79642076
Fall 58.72 10.91 279 81558 487350 79175201
Face oedema 58.18 10.91 104 81733 28032 79634519
Febrile neutropenia 58.11 10.91 92 81745 230907 79431644
Wound 56.81 10.91 24 81813 116155 79546396
Hallucinations, mixed 56.79 10.91 51 81786 6848 79655703
Sputum increased 56.62 10.91 43 81794 4570 79657981
Rash macular 56.18 10.91 104 81733 28795 79633756
Vaginal flatulence 55.51 10.91 34 81803 2541 79660010
Pneumonia mycoplasmal 55.16 10.91 28 81809 1450 79661101
International normalised ratio increased 52.80 10.91 199 81638 84522 79578029
Nightmare 52.72 10.91 95 81742 25766 79636785
Duodenal ulcer perforation 52.64 10.91 4 81833 66207 79596344
Mycobacterium avium complex infection 52.36 10.91 41 81796 4559 79657992
Pericarditis 51.83 10.91 21 81816 104215 79558336
Psoriasis 51.63 10.91 14 81823 89573 79572978
Psoriatic arthropathy 51.41 10.91 9 81828 77990 79584561
Contraindicated product prescribed 51.15 10.91 28 81809 1693 79660858
Cardioactive drug level increased 50.96 10.91 37 81800 3672 79658879
Embolism venous 50.90 10.91 39 81798 4200 79658351
Oral candidiasis 50.69 10.91 101 81736 29527 79633024
Rash erythematous 50.45 10.91 152 81685 57617 79604934
Paranoia 49.72 10.91 79 81758 19353 79643198
Rash 49.57 10.91 851 80986 577507 79085044
Glossodynia 49.49 10.91 22 81815 103315 79559236
Purpura 49.43 10.91 79 81758 19448 79643103
Pseudomembranous colitis 48.79 10.91 42 81795 5332 79657219
Arthralgia 47.86 10.91 367 81470 571436 79091115
Hypocoagulable state 47.80 10.91 29 81808 2130 79660421
Dyspnoea 45.69 10.91 1176 80661 855849 78806702
Liver function test abnormal 44.88 10.91 157 81680 64318 79598233
Lung consolidation 43.93 10.91 50 81787 8897 79653654
Intentional product use issue 43.79 10.91 55 81782 152057 79510494
Weight increased 43.34 10.91 143 81694 277243 79385308
Eosinophilic pneumonia 43.21 10.91 39 81798 5271 79657280
Pharyngeal swelling 42.85 10.91 46 81791 7673 79654878
Cerebrovascular accident 42.81 10.91 58 81779 155234 79507317
Hallucination, visual 42.72 10.91 100 81737 32629 79629922
Jaundice 42.54 10.91 136 81701 53213 79609338
Mycobacterium abscessus infection 42.28 10.91 22 81815 1200 79661351
General physical health deterioration 42.24 10.91 143 81694 275095 79387456
Injection site pain 41.66 10.91 43 81794 129795 79532756
Oral mucosal blistering 41.47 10.91 41 81796 6210 79656341
Mobility decreased 40.88 10.91 39 81798 122136 79540415
Clostridium difficile infection 40.80 10.91 116 81721 42569 79619982
Infusion related reaction 40.02 10.91 113 81724 230124 79432427
Mycobacterium chelonae infection 39.55 10.91 27 81810 2429 79660122
Hepatocellular injury 39.48 10.91 123 81714 47470 79615081
Hospitalisation 39.29 10.91 24 81813 94212 79568339
Discomfort 38.75 10.91 43 81794 125574 79536977
Off label use 38.72 10.91 677 81160 906538 78756013
Procedural pain 38.66 10.91 78 81759 23006 79639545
Muscle injury 38.42 10.91 3 81834 48558 79613993
Jarisch-Herxheimer reaction 38.27 10.91 19 81818 938 79661613
Mycobacterial infection 38.13 10.91 31 81806 3637 79658914
Haemoptysis 37.80 10.91 135 81702 55864 79606687
Deafness bilateral 37.53 10.91 25 81812 2160 79660391
Fixed eruption 37.28 10.91 28 81809 2926 79659625
Irritable bowel syndrome 37.26 10.91 9 81828 62232 79600319
Respiratory symptom 36.67 10.91 34 81803 4757 79657794
Pharyngeal erythema 36.53 10.91 24 81813 2026 79660525
Pruritus 36.43 10.91 588 81249 394060 79268491
Blood pressure fluctuation 35.95 10.91 12 81825 67133 79595418
Brief psychotic disorder with marked stressors 35.59 10.91 13 81824 296 79662255
Inhibitory drug interaction 34.86 10.91 32 81805 4421 79658130
Maternal exposure during pregnancy 34.68 10.91 54 81783 136484 79526067
Blood creatine phosphokinase increased 34.57 10.91 147 81690 65943 79596608
Impaired healing 34.27 10.91 24 81813 87631 79574920
Peripheral swelling 33.74 10.91 152 81685 269465 79393086
Transplant failure 33.72 10.91 32 81805 4609 79657942
Arthritis 33.63 10.91 41 81796 114839 79547712
Urinary tract infection 33.02 10.91 157 81680 274355 79388196
Coronary artery disease 32.86 10.91 13 81824 65461 79597090
Rales 32.80 10.91 67 81770 19934 79642617
Hepatic ischaemia 32.75 10.91 18 81819 1097 79661454
Candida infection 31.91 10.91 99 81738 38115 79624436
Throat tightness 31.87 10.91 81 81756 27826 79634725
Musculoskeletal stiffness 31.82 10.91 84 81753 174924 79487627
Proctitis 31.67 10.91 36 81801 6396 79656155
Infection 31.62 10.91 134 81703 241578 79420973
Blood pressure increased 31.61 10.91 111 81726 211249 79451302
Renal impairment 31.60 10.91 273 81564 157510 79505041
Productive cough 31.47 10.91 176 81661 88155 79574396
Drug reaction with eosinophilia and systemic symptoms 31.39 10.91 140 81697 64104 79598447
Depersonalisation/derealisation disorder 31.25 10.91 21 81816 1841 79660710
Knee arthroplasty 30.77 10.91 4 81833 43244 79619307
Eosinophilic pneumonia acute 30.26 10.91 17 81820 1081 79661470
Weber tuning fork test abnormal 29.82 10.91 9 81828 110 79662441
Injection site erythema 29.80 10.91 22 81815 78175 79584376
Oropharyngeal blistering 29.69 10.91 15 81822 769 79661782
Deafness neurosensory 29.63 10.91 36 81801 6862 79655689
Product use issue 29.53 10.91 113 81724 209709 79452842
Nasal polyps 29.48 10.91 37 81800 7290 79655261
Rash maculovesicular 29.37 10.91 7 81830 31 79662520
Deafness 29.35 10.91 66 81771 20971 79641580
Vomiting 29.32 10.91 892 80945 664936 78997615
Malignant neoplasm progression 28.95 10.91 60 81777 135930 79526621
Dermatitis allergic 28.87 10.91 60 81777 18070 79644481
Drug monitoring procedure not performed 28.81 10.91 16 81821 995 79661556
Neuropsychiatric symptoms 28.77 10.91 18 81819 1397 79661154
Hepatic enzyme increased 28.60 10.91 94 81743 182516 79480035
Skin exfoliation 28.39 10.91 122 81715 54978 79607573
Liver disorder 28.30 10.91 148 81689 72269 79590282
Intentional overdose 27.78 10.91 41 81796 105919 79556632
Blood cholesterol increased 27.68 10.91 27 81810 83693 79578858
Musculoskeletal pain 27.43 10.91 39 81798 102315 79560236
Oculomucocutaneous syndrome 27.34 10.91 11 81826 328 79662223
Multiple sclerosis relapse 27.32 10.91 7 81830 46526 79616025
Pain in extremity 27.24 10.91 241 81596 364297 79298254
Adverse event 27.02 10.91 14 81823 60200 79602351
Tinnitus 26.68 10.91 103 81734 44230 79618321
Myocardial infarction 26.67 10.91 98 81739 184031 79478520
Therapeutic product effect decreased 26.60 10.91 83 81754 163780 79498771
Serum sickness-like reaction 26.56 10.91 13 81824 622 79661929
Diffuse alveolar damage 26.48 10.91 25 81812 3579 79658972
Euphoric mood 26.40 10.91 36 81801 7690 79654861
Muscle relaxant therapy 26.26 10.91 9 81828 169 79662382
Helicobacter gastritis 26.10 10.91 21 81816 2428 79660123
Pulmonary physical examination abnormal 26.08 10.91 6 81831 22 79662529
Abnormal dreams 25.96 10.91 44 81793 11368 79651183
Pressure of speech 25.92 10.91 16 81821 1212 79661339
Vaginal discharge 25.85 10.91 35 81802 7428 79655123
Nosocomial infection 25.44 10.91 22 81815 2810 79659741
Substance-induced mood disorder 25.19 10.91 8 81829 117 79662434
Red blood cell sedimentation rate increased 24.97 10.91 8 81829 45934 79616617
Eczema 24.70 10.91 95 81742 40723 79621828
Mononucleosis syndrome 24.59 10.91 8 81829 127 79662424
Ill-defined disorder 24.50 10.91 19 81818 65856 79596695
Bipolar I disorder 24.28 10.91 19 81818 2110 79660441
Injection site reaction 24.20 10.91 13 81824 54772 79607779
Cytokine release syndrome 24.06 10.91 4 81833 35994 79626557
Heart rate decreased 24.04 10.91 22 81815 70294 79592257
Hip arthroplasty 23.84 10.91 4 81833 35752 79626799
Pharyngeal oedema 23.77 10.91 52 81785 16220 79646331
Palatal oedema 23.68 10.91 16 81821 1415 79661136
Psychomotor hyperactivity 23.66 10.91 53 81784 16796 79645755
Prescribed overdose 23.63 10.91 5 81832 37878 79624673
Hepatitis fulminant 23.56 10.91 33 81804 7229 79655322
Primary hypoparathyroidism 23.52 10.91 6 81831 37 79662514
Agranulocytosis 23.42 10.91 100 81737 44930 79617621
Folliculitis 23.23 10.91 14 81823 55366 79607185
Trichoglossia 23.19 10.91 12 81825 647 79661904
Abdominal pain upper 23.12 10.91 340 81497 223479 79439072
Hypoaesthesia 23.09 10.91 100 81737 179252 79483299
Wheezing 22.91 10.91 201 81636 116463 79546088
Radiculopathy 22.75 10.91 36 81801 8788 79653763
Confusional state 22.66 10.91 455 81382 317542 79345009
Injection site phlebitis 22.60 10.91 8 81829 166 79662385
Hypomania 22.59 10.91 33 81804 7511 79655040
Acid fast bacilli infection 22.51 10.91 8 81829 168 79662383
Meningitis streptococcal 22.42 10.91 8 81829 170 79662381
Diastolic dysfunction 22.40 10.91 40 81797 10771 79651780
Upper respiratory tract inflammation 22.32 10.91 24 81813 4011 79658540
Lymphocyte stimulation test positive 22 10.91 14 81823 1119 79661432
Cardiac disorder 21.98 10.91 21 81816 65736 79596815
Intentional product misuse 21.98 10.91 40 81797 95125 79567426
Type 2 diabetes mellitus 21.86 10.91 16 81821 57106 79605445
Acinetobacter infection 21.82 10.91 20 81817 2757 79659794
Insomnia 21.74 10.91 363 81474 244807 79417744
Cardio-respiratory arrest 21.34 10.91 50 81787 108460 79554091
Labile blood pressure 21.25 10.91 18 81819 2235 79660316
Otitis media fungal 21.19 10.91 5 81832 21 79662530
Injection site swelling 21.09 10.91 11 81826 47121 79615430
Acute myocardial infarction 20.99 10.91 29 81808 77007 79585544
COVID-19 treatment 20.80 10.91 10 81827 460 79662091
Toxic skin eruption 20.74 10.91 60 81777 22233 79640318
HIV associated nephropathy 20.68 10.91 9 81828 328 79662223
Mental status changes 20.56 10.91 23 81814 66936 79595615
Hallucination, auditory 20.52 10.91 57 81780 20636 79641915
Therapeutic response decreased 20.48 10.91 23 81814 66830 79595721
Mouth swelling 20.38 10.91 28 81809 6023 79656528
Disorganised speech 20.15 10.91 17 81820 2100 79660451
Stenotrophomonas infection 20.09 10.91 22 81815 3751 79658800
Photopsia 19.98 10.91 26 81811 5310 79657241
Wrong technique in product usage process 19.94 10.91 28 81809 73847 79588704
Cough 19.92 10.91 505 81332 366284 79296267
Irregular breathing 19.88 10.91 10 81827 508 79662043
Bronchostenosis 19.87 10.91 11 81826 680 79661871
Petechiae 19.76 10.91 56 81781 20509 79642042
Gingival swelling 19.71 10.91 24 81813 4585 79657966
Nasal mucosal disorder 19.64 10.91 9 81828 371 79662180
Delusional perception 19.64 10.91 9 81828 371 79662180
Tongue exfoliation 19.61 10.91 7 81830 149 79662402
Prostate cancer 19.54 10.91 5 81832 33263 79629288
Penile erythema 19.52 10.91 7 81830 151 79662400
Anamnestic reaction 19.44 10.91 5 81832 32 79662519
Pulmonary cavitation 19.37 10.91 15 81822 1641 79660910
Hip fracture 19.31 10.91 4 81833 30757 79631794
Oesophageal carcinoma 19.21 10.91 38 81799 11046 79651505
Haemostasis 19.16 10.91 9 81828 393 79662158
Neoplasm progression 19.10 10.91 15 81822 51667 79610884
COVID-19 19.05 10.91 90 81747 157584 79504967
Staphylococcal scalded skin syndrome 18.93 10.91 9 81828 404 79662147
Muscle necrosis 18.80 10.91 14 81823 1444 79661107
Injection site pruritus 18.72 10.91 10 81827 42273 79620278
Anticonvulsant drug level increased 18.72 10.91 18 81819 2635 79659916
Abdominal wall haematoma 18.65 10.91 24 81813 4849 79657702
Disease recurrence 18.53 10.91 92 81745 44017 79618534
Hysterectomy 18.15 10.91 27 81810 6245 79656306
Bleeding time prolonged 18.10 10.91 13 81824 1268 79661283
Clumsiness 18.00 10.91 19 81818 3108 79659443
Urticaria papular 17.95 10.91 7 81830 192 79662359
Bronchopulmonary aspergillosis 17.92 10.91 57 81780 22237 79640314
Anxiety 17.84 10.91 356 81481 248156 79414395
Oxygen saturation decreased 17.83 10.91 70 81767 128977 79533574
Dyspepsia 17.71 10.91 180 81657 108507 79554044
Sciatica 17.67 10.91 6 81831 33216 79629335
Rash papular 17.58 10.91 56 81781 21860 79640691
Cardiomyopathy 17.54 10.91 4 81833 28770 79633781
Blood pressure systolic increased 17.48 10.91 26 81811 66960 79595591
Blood glucose increased 17.44 10.91 60 81777 114915 79547636
Acute hepatic failure 17.34 10.91 69 81768 30044 79632507
Symmetrical drug-related intertriginous and flexural exanthema 17.33 10.91 11 81826 875 79661676
Coagulopathy 17.24 10.91 78 81759 35928 79626623
Eosinophilic granulomatosis with polyangiitis 17.21 10.91 20 81817 3640 79658911
Unevaluable event 17.16 10.91 19 81818 55566 79606985
Metastases to liver 17.13 10.91 4 81833 28310 79634241
Transaminases increased 17.05 10.91 101 81736 51642 79610909
Coma 17.03 10.91 50 81787 100599 79561952
Labelled drug-drug interaction issue 16.96 10.91 13 81824 1400 79661151
Dermatitis bullous 16.95 10.91 42 81795 14203 79648348
Renal ischaemia 16.90 10.91 12 81825 1150 79661401
Tongue dry 16.90 10.91 12 81825 1150 79661401
Motion sickness 16.90 10.91 11 81826 914 79661637
Delusion of grandeur 16.81 10.91 13 81824 1419 79661132
Abnormal behaviour 16.77 10.91 78 81759 36343 79626208
Hypertension 16.72 10.91 239 81598 330753 79331798
Skin lesion 16.68 10.91 86 81751 41758 79620793
Loss of personal independence in daily activities 16.61 10.91 52 81785 102528 79560023
Product quality issue 16.60 10.91 7 81830 33933 79628618
Paraparesis 16.59 10.91 20 81817 3783 79658768
Henoch-Schonlein purpura 16.56 10.91 17 81820 2693 79659858
Pneumococcal infection 16.55 10.91 11 81826 947 79661604
Neoplasm malignant 16.49 10.91 6 81831 31804 79630747
Therapy cessation 16.46 10.91 9 81828 37553 79624998
Gait disturbance 16.46 10.91 135 81702 207371 79455180
Hypotension 16.40 10.91 336 81501 439981 79222570
Respiratory tract infection bacterial 16.40 10.91 15 81822 2062 79660489
Bladder irrigation 16.36 10.91 5 81832 64 79662487
Vanishing bile duct syndrome 16.35 10.91 14 81823 1764 79660787
Asthenia 16.35 10.91 400 81437 511289 79151262
Neck pain 16.28 10.91 33 81804 75384 79587167
Oesophageal pain 16.26 10.91 21 81816 4258 79658293
Sitting disability 16.23 10.91 8 81829 389 79662162
Legionella test positive 16.22 10.91 4 81833 21 79662530
Papule 16.11 10.91 28 81809 7379 79655172
Lower respiratory tract infection 16.08 10.91 203 81634 129017 79533534
Repetitive speech 16.06 10.91 8 81829 398 79662153
Obesity 16.01 10.91 8 81829 35117 79627434
Hepatosplenomegaly 15.98 10.91 25 81812 6044 79656507
Neuromyopathy 15.84 10.91 13 81824 1545 79661006
Mucosal discolouration 15.79 10.91 10 81827 793 79661758
Granulomatous dermatitis 15.78 10.91 8 81829 413 79662138
Phalangeal hypoplasia 15.77 10.91 4 81833 24 79662527
Dissociation 15.69 10.91 20 81817 4001 79658550
Lip erythema 15.69 10.91 7 81830 271 79662280
Diarrhoea 15.68 10.91 1076 80761 879413 78783138
Haemoglobin decreased 15.64 10.91 149 81688 221970 79440581
Urine alcohol test positive 15.63 10.91 4 81833 25 79662526
Acute generalised exanthematous pustulosis 15.63 10.91 46 81791 17208 79645343
Pearly penile papules 15.57 10.91 3 81834 3 79662548
Blood catecholamines abnormal 15.57 10.91 3 81834 3 79662548
Neurosis 15.50 10.91 8 81829 429 79662122
Overdose 15.46 10.91 118 81719 184088 79478463
Iridocyclitis 15.38 10.91 19 81818 3685 79658866
Mouth ulceration 15.37 10.91 79 81758 38315 79624236
Disinhibition 15.34 10.91 16 81821 2582 79659969
Eosinophilia 15.26 10.91 89 81748 45256 79617295
Transient ischaemic attack 15.21 10.91 19 81818 52676 79609875
Oral discomfort 15.19 10.91 32 81805 9728 79652823
Panic attack 15.18 10.91 57 81780 24159 79638392
Drug intolerance 15.06 10.91 186 81651 263933 79398618
Tongue coated 14.99 10.91 12 81825 1377 79661174
Psychotic behaviour 14.92 10.91 11 81826 1118 79661433
No adverse event 14.78 10.91 10 81827 37182 79625369
Tangentiality 14.76 10.91 6 81831 184 79662367
Skin reaction 14.71 10.91 43 81794 16025 79646526
Congenital foot malformation 14.67 10.91 4 81833 33 79662518
Muscle spasms 14.63 10.91 112 81725 174618 79487933
Stress 14.63 10.91 38 81799 79574 79582977
Corneal deposits 14.52 10.91 8 81829 490 79662061
Acute respiratory distress syndrome 14.51 10.91 86 81751 43981 79618570
Therapy interrupted 14.49 10.91 7 81830 31334 79631217
Functional residual capacity increased 14.49 10.91 5 81832 96 79662455
School refusal 14.46 10.91 4 81833 35 79662516
Antineutrophil cytoplasmic antibody 14.46 10.91 4 81833 35 79662516
Palmar-plantar erythrodysaesthesia syndrome 14.43 10.91 8 81829 33126 79629425
Small intestinal obstruction 14.38 10.91 5 81832 27267 79635284
Lip discolouration 14.38 10.91 9 81828 699 79661852
Chloasma 14.26 10.91 4 81833 37 79662514
Conjunctival hyperaemia 14.24 10.91 20 81817 4393 79658158
Surgery 14.14 10.91 8 81829 32758 79629793
Flushing 14.11 10.91 45 81792 88223 79574328
Mononeuropathy 14.01 10.91 6 81831 210 79662341
Pneumomediastinum 13.94 10.91 18 81819 3649 79658902
Skin bacterial infection 13.87 10.91 8 81829 535 79662016
Lipoedema 13.85 10.91 6 81831 216 79662335
Lip erosion 13.77 10.91 12 81825 1548 79661003
Urinary bladder rupture 13.72 10.91 5 81832 113 79662438
Beta 2 microglobulin increased 13.71 10.91 7 81830 367 79662184
Hot flush 13.65 10.91 22 81815 54855 79607696
Gastric disorder 13.60 10.91 75 81762 37358 79625193
Nephrolithiasis 13.60 10.91 21 81816 53270 79609281
Hyperkalaemia 13.51 10.91 178 81659 114220 79548331
Hypo HDL cholesterolaemia 13.50 10.91 3 81834 9 79662542
Pneumonia bacterial 13.38 10.91 47 81790 19284 79643267
Staring 13.36 10.91 15 81822 2630 79659921
Rash pruritic 13.33 10.91 122 81715 71507 79591044
Disorientation 13.29 10.91 110 81727 62666 79599885
Conductive deafness 13.29 10.91 6 81831 239 79662312
Helicobacter test positive 13.26 10.91 11 81826 1327 79661224
Kounis syndrome 13.21 10.91 19 81818 4263 79658288
Derealisation 13.20 10.91 12 81825 1637 79660914
Joint injury 13.03 10.91 8 81829 31327 79631224
Urinary tract inflammation 12.95 10.91 6 81831 254 79662297
Multiple organ dysfunction syndrome 12.93 10.91 184 81653 120062 79542489
Abdominal pain 12.84 10.91 505 81332 389064 79273487
Paradoxical pain 12.83 10.91 3 81834 12 79662539
Memory impairment 12.79 10.91 65 81772 111669 79550882
Injury 12.75 10.91 39 81798 77457 79585094
Morganella infection 12.73 10.91 10 81827 1117 79661434
Hepatic steatosis 12.65 10.91 74 81763 37664 79624887
Persecutory delusion 12.61 10.91 20 81817 4889 79657662
Ataxia 12.56 10.91 55 81782 24984 79637567
Toxic optic neuropathy 12.53 10.91 10 81827 1143 79661408
Drug dependence 12.52 10.91 14 81823 40755 79621796
Systemic toxicity 12.49 10.91 5 81832 147 79662404
Emphysema 12.49 10.91 41 81796 16259 79646292
Appendicitis 12.46 10.91 3 81834 20791 79641760
Basal cell carcinoma 12.42 10.91 12 81825 37363 79625188
Pregnancy 12.41 10.91 6 81831 26845 79635706
Dysphagia 12.39 10.91 185 81652 121951 79540600
CD4/CD8 ratio decreased 12.38 10.91 4 81833 62 79662489
Necrotising panniculitis 12.38 10.91 4 81833 62 79662489
Epilepsy 12.35 10.91 78 81759 40782 79621769
Acinetobacter bacteraemia 12.34 10.91 6 81831 283 79662268
Patient isolation 12.32 10.91 4 81833 63 79662488
Stomatitis 12.32 10.91 94 81743 146663 79515888
Hypersensitivity vasculitis 12.27 10.91 24 81813 6919 79655632
Cross sensitivity reaction 12.24 10.91 17 81820 3695 79658856
Tubulointerstitial nephritis 12.19 10.91 74 81763 38161 79624390
Iris atrophy 12.19 10.91 5 81832 157 79662394
Pulmonary arterial hypertension 12.14 10.91 7 81830 28359 79634192
Erythrosis 12.13 10.91 5 81832 159 79662392
Drug ineffective for unapproved indication 12.06 10.91 92 81745 51146 79611405
Adrenoleukodystrophy 12.04 10.91 4 81833 68 79662483
Dysbiosis 12.04 10.91 10 81827 1209 79661342
Gastroenteritis eosinophilic 12.03 10.91 6 81831 299 79662252
Panic reaction 11.98 10.91 19 81818 4646 79657905
Vulval haemorrhage 11.98 10.91 3 81834 17 79662534
Delusion 11.92 10.91 47 81790 20376 79642175
Tooth disorder 11.92 10.91 6 81831 26227 79636324
Pigmentation disorder 11.91 10.91 21 81816 5597 79656954
Hyperacusis 11.90 10.91 13 81824 2210 79660341
Polycystic liver disease 11.87 10.91 5 81832 168 79662383
Hyperleukocytosis 11.83 10.91 14 81823 2596 79659955
Circumoral oedema 11.74 10.91 6 81831 315 79662236
Drug withdrawal syndrome 11.71 10.91 11 81826 34707 79627844
Delusional disorder, persecutory type 11.70 10.91 7 81830 501 79662050
Asthma 11.59 10.91 199 81638 134896 79527655
Post procedural complication 11.52 10.91 5 81832 23824 79638727
Dysarthria 11.50 10.91 113 81724 67509 79595042
Induration 11.49 10.91 12 81825 1940 79660611
pH body fluid increased 11.48 10.91 4 81833 79 79662472
Hepatomegaly 11.48 10.91 44 81793 18830 79643721
Cholestasis 11.40 10.91 92 81745 52017 79610534
Thrombosis 11.37 10.91 46 81791 84054 79578497
Necrosis 11.31 10.91 28 81809 9465 79653086
Neuropsychiatric lupus 11.24 10.91 5 81832 192 79662359
Bronchial obstruction 11.17 10.91 14 81823 2754 79659797
Cardiomegaly 11.09 10.91 55 81782 26297 79636254
Femur fracture 11.09 10.91 14 81823 38638 79623913
Blood pressure diastolic abnormal 11.06 10.91 3 81834 19199 79643352
Breast cancer 11.04 10.91 11 81826 33770 79628781
Anaphylactic reaction 11.03 10.91 133 81704 83610 79578941
Lower limb fracture 11.02 10.91 5 81832 23210 79639341
Excessive eye blinking 11.00 10.91 11 81826 1690 79660861
Oscillopsia 10.98 10.91 5 81832 203 79662348
Respiratory papilloma 10.97 10.91 3 81834 25 79662526
Mitral valve incompetence 10.93 10.91 8 81829 28557 79633994
Tuberculosis gastrointestinal 10.92 10.91 7 81830 567 79661984

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC A02BD04 ALIMENTARY TRACT AND METABOLISM
DRUGS FOR ACID RELATED DISORDERS
DRUGS FOR PEPTIC ULCER AND GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD)
Combinations for eradication of Helicobacter pylori
ATC A02BD05 ALIMENTARY TRACT AND METABOLISM
DRUGS FOR ACID RELATED DISORDERS
DRUGS FOR PEPTIC ULCER AND GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD)
Combinations for eradication of Helicobacter pylori
ATC A02BD06 ALIMENTARY TRACT AND METABOLISM
DRUGS FOR ACID RELATED DISORDERS
DRUGS FOR PEPTIC ULCER AND GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD)
Combinations for eradication of Helicobacter pylori
ATC A02BD07 ALIMENTARY TRACT AND METABOLISM
DRUGS FOR ACID RELATED DISORDERS
DRUGS FOR PEPTIC ULCER AND GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD)
Combinations for eradication of Helicobacter pylori
ATC A02BD09 ALIMENTARY TRACT AND METABOLISM
DRUGS FOR ACID RELATED DISORDERS
DRUGS FOR PEPTIC ULCER AND GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD)
Combinations for eradication of Helicobacter pylori
ATC A02BD11 ALIMENTARY TRACT AND METABOLISM
DRUGS FOR ACID RELATED DISORDERS
DRUGS FOR PEPTIC ULCER AND GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD)
Combinations for eradication of Helicobacter pylori
ATC A02BD12 ALIMENTARY TRACT AND METABOLISM
DRUGS FOR ACID RELATED DISORDERS
DRUGS FOR PEPTIC ULCER AND GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD)
Combinations for eradication of Helicobacter pylori
ATC A02BD14 ALIMENTARY TRACT AND METABOLISM
DRUGS FOR ACID RELATED DISORDERS
DRUGS FOR PEPTIC ULCER AND GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD)
Combinations for eradication of Helicobacter pylori
ATC J01FA09 ANTIINFECTIVES FOR SYSTEMIC USE
ANTIBACTERIALS FOR SYSTEMIC USE
MACROLIDES, LINCOSAMIDES AND STREPTOGRAMINS
Macrolides
FDA CS M0028311 Macrolides
CHEBI has role CHEBI:35703 Xenobiotic
CHEBI has role CHEBI:36047 antibacterial drugs
CHEBI has role CHEBI:48001 protein synthesis inhibitors
CHEBI has role CHEBI:78298 environmental contaminants
FDA EPC N0000175935 Macrolide Antimicrobial
FDA MoA N0000182141 Cytochrome P450 3A4 Inhibitors
FDA MoA N0000185503 P-Glycoprotein Inhibitors
FDA MoA N0000190114 Cytochrome P450 3A Inhibitors
MeSH PA D000900 Anti-Bacterial Agents
MeSH PA D000890 Anti-Infective Agents
MeSH PA D065692 Cytochrome P-450 CYP3A Inhibitors
MeSH PA D065607 Cytochrome P-450 Enzyme Inhibitors
MeSH PA D004791 Enzyme Inhibitors
MeSH PA D065606 Metabolic Side Effects of Drugs and Substances
MeSH PA D011500 Protein Synthesis Inhibitors

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

DiseaseRelationSNOMED_IDDOID
Acute otitis media indication 3110003
Haemophilus Influenzae Acute Otitis Media indication 19021002
Infection of skin AND/OR subcutaneous tissue indication 19824006
Streptococcal tonsillitis indication 41582007
Pneumonia due to Mycoplasma pneumoniae indication 46970008
Bacterial pneumonia indication 53084003 DOID:874
Acute maxillary sinusitis indication 68272006 DOID:2050
Haemophilus influenzae pneumonia indication 70036007
Acute bacterial sinusitis indication 75498004
Pulmonary Mycobacterium avium complex infection indication 186342000
Acute Moraxella catarrhalis bronchitis indication 195722003
Acute bacterial bronchitis indication 233598009
Pneumococcal pneumonia indication 233607000
Chlamydial pneumonia indication 233609002
Streptococcus pyogenes infection indication 302809008
Infective otitis media indication 312218008
Infection due to Staphylococcus aureus indication 406602003
Acute exacerbation of chronic bronchitis indication 425748003
Moraxella Catarrhalis Acute Otitis Media indication 703469002
Infection caused by Helicobacter pylori indication 721730009
Duodenal Ulcer due to H. Pylori indication
Haemophilus Influenzae Bronchitis indication
Haemophilus Parainfluenzae Pneumonia indication
Streptococcus Pneumoniae Bronchitis indication
Moraxella Catarrhalis Pneumonia indication
Inhalational anthrax off-label use 11389007
Lyme disease off-label use 23502006 DOID:11729
Pertussis off-label use 27836007
Gastrointestinal anthrax off-label use 111798006 DOID:13386
Boutonneuse fever off-label use 186774005 DOID:14095
Legionnaires' Disease off-label use
Prevention of Bacterial Endocarditis off-label use
Ventricular tachycardia contraindication 25569003
Obstruction of bile duct contraindication 30144000
Torsades de pointes contraindication 31722008
Acute nephropathy contraindication 58574008
Hepatic failure contraindication 59927004
Osteoporosis contraindication 64859006 DOID:11476
Kidney disease contraindication 90708001 DOID:557
Myasthenia gravis contraindication 91637004 DOID:437
Cholestatic hepatitis contraindication 95556007
Prolonged QT interval contraindication 111975006
Fracture of bone contraindication 125605004
Liver function tests abnormal contraindication 166603001
Hypomagnesemia contraindication 190855004
Disease of liver contraindication 235856003 DOID:409
Infectious mononucleosis contraindication 271558008 DOID:8568
Pseudomembranous enterocolitis contraindication 397683000
Porphyria contraindication 418470004




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 12.66 acidic
pKa2 8.65 Basic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
500MG;500MG;EQ 20MG BASE VOQUEZNA TRIPLE PAK PHATHOM N215152 May 3, 2022 DISCN CAPSULE, TABLET, TABLET ORAL May 3, 2027 NEW CHEMICAL ENTITY
500MG;500MG;EQ 20MG BASE VOQUEZNA TRIPLE PAK PHATHOM N215152 May 3, 2022 DISCN CAPSULE, TABLET, TABLET ORAL May 3, 2032 GENERATING ANTIBIOTIC INCENTIVES NOW

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])		Mechanism
action		Bioact sourceMoA source
Potassium voltage-gated channel subfamily H member 2 Ion channel IC50 4.23 WOMBAT-PK

External reference:

IDSource
4020086 VUID
N0000148093 NUI
D00276 KEGG_DRUG
203729 RXNORM
4020086 VANDF
C0055856 UMLSCUI
CHEBI:3732 CHEBI
CTY PDB_CHEM_ID
CHEMBL1741 ChEMBL_ID
D017291 MESH_DESCRIPTOR_UI
DB01211 DRUGBANK_ID
C040934 MESH_SUPPLEMENTAL_RECORD_UI
10903 IUPHAR_LIGAND_ID
6252 INN_ID
H1250JIK0A UNII
84029 PUBCHEM_CID
3947 MMSL
4462 MMSL
68470 MMSL
d00097 MMSL
003608 NDDF
387487009 SNOMEDCT_US
83999008 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Clarithromycin HUMAN PRESCRIPTION DRUG LABEL 1 0527-1930 TABLET, FILM COATED, EXTENDED RELEASE 500 mg ORAL ANDA 26 sections
Clarithromycin HUMAN PRESCRIPTION DRUG LABEL 1 0527-1930 TABLET, FILM COATED, EXTENDED RELEASE 500 mg ORAL ANDA 26 sections
Clarithromycin HUMAN PRESCRIPTION DRUG LABEL 1 0527-1930 TABLET, FILM COATED, EXTENDED RELEASE 500 mg ORAL ANDA 26 sections
Clarithromycin HUMAN PRESCRIPTION DRUG LABEL 1 0527-1931 TABLET, FILM COATED 250 mg ORAL ANDA 28 sections
Clarithromycin HUMAN PRESCRIPTION DRUG LABEL 1 0527-1931 TABLET, FILM COATED 250 mg ORAL ANDA 28 sections
Clarithromycin HUMAN PRESCRIPTION DRUG LABEL 1 0527-1932 TABLET, FILM COATED 500 mg ORAL ANDA 28 sections
Clarithromycin HUMAN PRESCRIPTION DRUG LABEL 1 0527-1932 TABLET, FILM COATED 500 mg ORAL ANDA 28 sections
clarithromycin HUMAN PRESCRIPTION DRUG LABEL 1 0591-2805 TABLET, FILM COATED, EXTENDED RELEASE 500 mg ORAL ANDA 26 sections
clarithromycin HUMAN PRESCRIPTION DRUG LABEL 1 0591-2805 TABLET, FILM COATED, EXTENDED RELEASE 500 mg ORAL ANDA 26 sections
Clarithromycin HUMAN PRESCRIPTION DRUG LABEL 1 0781-1961 TABLET 250 mg ORAL ANDA 29 sections
Clarithromycin HUMAN PRESCRIPTION DRUG LABEL 1 0781-1962 TABLET 500 mg ORAL ANDA 29 sections
Clarithromycin HUMAN PRESCRIPTION DRUG LABEL 1 0781-6022 FOR SUSPENSION 125 mg ORAL ANDA 28 sections
Clarithromycin HUMAN PRESCRIPTION DRUG LABEL 1 0781-6022 FOR SUSPENSION 125 mg ORAL ANDA 28 sections
Clarithromycin HUMAN PRESCRIPTION DRUG LABEL 1 0781-6023 FOR SUSPENSION 250 mg ORAL ANDA 28 sections
Clarithromycin HUMAN PRESCRIPTION DRUG LABEL 1 0781-6023 FOR SUSPENSION 250 mg ORAL ANDA 28 sections
Clarithromycin HUMAN PRESCRIPTION DRUG LABEL 1 0904-6872 TABLET, FILM COATED 500 mg ORAL ANDA 28 sections
Clarithromycin HUMAN PRESCRIPTION DRUG LABEL 1 10544-522 TABLET, FILM COATED 500 mg ORAL ANDA 22 sections
Clarithromycin HUMAN PRESCRIPTION DRUG LABEL 1 10544-952 TABLET, COATED 500 mg ORAL ANDA 23 sections
Clarithromycin HUMAN PRESCRIPTION DRUG LABEL 1 21695-557 TABLET 250 mg ORAL ANDA 26 sections
Clarithromycin HUMAN PRESCRIPTION DRUG LABEL 1 21695-558 TABLET 500 mg ORAL ANDA 26 sections
Clarithromycin Human Prescription Drug Label 1 27241-064 TABLET 250 mg ORAL ANDA 28 sections
Clarithromycin Human Prescription Drug Label 1 27241-064 TABLET 250 mg ORAL ANDA 28 sections
Clarithromycin Human Prescription Drug Label 1 27241-065 TABLET 500 mg ORAL ANDA 28 sections
Clarithromycin Human Prescription Drug Label 1 27241-065 TABLET 500 mg ORAL ANDA 28 sections
Clarithromycin HUMAN PRESCRIPTION DRUG LABEL 1 33261-618 TABLET, FILM COATED 500 mg ORAL ANDA 22 sections
Clarithromycin HUMAN PRESCRIPTION DRUG LABEL 1 33261-631 TABLET, FILM COATED 250 mg ORAL ANDA 22 sections
Clarithromycin HUMAN PRESCRIPTION DRUG LABEL 1 42254-188 TABLET, FILM COATED 500 mg ORAL ANDA 21 sections
clarithromycin HUMAN PRESCRIPTION DRUG LABEL 1 43063-520 TABLET, FILM COATED, EXTENDED RELEASE 500 mg ORAL ANDA 26 sections
Clarithromycin HUMAN PRESCRIPTION DRUG LABEL 1 43063-530 TABLET 500 mg ORAL ANDA 29 sections
Clarithromycin HUMAN PRESCRIPTION DRUG LABEL 1 43063-530 TABLET 500 mg ORAL ANDA 29 sections