amoxicillin Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
antibiotics, 6-aminopenicillanic acid derivatives 192 26787-78-0

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • amoxicillin trihydrate
  • amoxicillin
  • amocilline
  • amoxcillin
  • amoxycillin
  • amoxicillin sodium
  • amoxicillin anhydrous
  • amoxicillin hydrate
A broad-spectrum semisynthetic antibiotic similar to AMPICILLIN except that its resistance to gastric acid permits higher serum levels with oral administration.
  • Molecular weight: 365.40
  • Formula: C16H19N3O5S
  • CLOGP: -1.87
  • LIPINSKI: 0
  • HAC: 8
  • HDO: 4
  • TPSA: 132.96
  • ALOGS: -2.58
  • ROTB: 4

  • Status: OFP

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

Drug dosage:

DoseUnitRoute
1.50 g O
3 g P
1.50 g O
3 g P

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 3 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 3.50 mg/mL Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 86 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 68.42 ┬ÁM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 93 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution) 0.25 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 3.30 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.85 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 1.10 hours Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
Dec. 9, 1974 FDA APOTHECON

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 hypersensitivity 1331.41 9.50 2275 115227 241550 46327010
Drug reaction with eosinophilia and systemic symptoms 625.82 9.50 550 116952 28998 46539562
Rash maculo-papular 608.76 9.50 528 116974 27346 46541214
Pruritus 491.55 9.50 1531 115971 240821 46327739
Urticaria 461.08 9.50 956 116546 116936 46451624
Angioedema 353.82 9.50 465 117037 38877 46529683
Anaphylactic reaction 346.91 9.50 539 116963 52573 46515987
Anaphylactic shock 341.13 9.50 332 117170 19942 46548618
Erythema 340.10 9.50 956 116546 141864 46426696
Acute generalised exanthematous pustulosis 335.18 9.50 238 117264 9167 46559393
Rash 302.70 9.50 1725 115777 354787 46213773
Lip oedema 264.12 9.50 141 117361 3223 46565337
Type IV hypersensitivity reaction 259.06 9.50 127 117375 2413 46566147
Cholestasis 234.25 9.50 313 117189 26580 46541980
Lip swelling 231.12 9.50 302 117200 25093 46543467
Completed suicide 226.14 9.50 46 117456 145874 46422686
Toxic skin eruption 219.97 9.50 209 117293 12178 46556382
Hepatocellular injury 218.90 9.50 318 117184 29204 46539356
Face oedema 213.18 9.50 252 117250 18901 46549659
Drug-induced liver injury 199.45 9.50 281 117221 25087 46543473
Maternal exposure during pregnancy 196.29 9.50 636 116866 101913 46466647
Drug ineffective 191.24 9.50 969 116533 676869 45891691
Death 182.89 9.50 355 117147 335193 46233367
Abortion spontaneous 182.21 9.50 364 117138 43282 46525278
Rheumatoid arthritis 175.32 9.50 208 117294 240007 46328553
Acute kidney injury 171.37 9.50 1097 116405 234758 46333802
Jaundice 166.70 9.50 277 117225 28568 46539992
Type I hypersensitivity 158.38 9.50 89 117413 2257 46566303
Clostridium difficile infection 153.08 9.50 247 117255 24856 46543704
Hepatitis cholestatic 152.82 9.50 130 117372 6547 46562013
Stevens-Johnson syndrome 150.01 9.50 235 117267 23062 46545498
Fall 141.60 9.50 395 117107 328702 46239858
Eosinophilia 136.65 9.50 203 117299 19014 46549546
Documented hypersensitivity to administered product 134.83 9.50 52 117450 533 46568027
Tongue oedema 121.52 9.50 92 117410 3914 46564646
Tubulointerstitial nephritis 120.99 9.50 167 117335 14621 46553939
Enterocolitis haemorrhagic 119.35 9.50 64 117438 1476 46567084
Crystalluria 117.41 9.50 43 117459 377 46568183
Rash pruritic 115.98 9.50 307 117195 43908 46524652
Swollen tongue 113.93 9.50 237 117265 28995 46539565
Toxic epidermal necrolysis 113.06 9.50 202 117300 22076 46546484
Clostridium difficile colitis 112.36 9.50 182 117320 18371 46550189
Erythema multiforme 111.83 9.50 130 117372 9574 46558986
Rash macular 108.66 9.50 183 117319 19077 46549483
Infusion related reaction 103.87 9.50 63 117439 101145 46467415
Arthralgia 103.55 9.50 519 116983 364084 46204476
Pyrexia 94.66 9.50 1314 116188 347488 46221072
Rash erythematous 92.63 9.50 241 117261 34109 46534451
Toxicity to various agents 92.56 9.50 252 117250 211514 46357046
Fatigue 91.37 9.50 1037 116465 607660 45960900
Therapeutic product effect decreased 91.12 9.50 47 117455 82554 46486006
Pemphigus 87.47 9.50 7 117495 45267 46523293
Swelling face 86.44 9.50 312 117190 52747 46515813
White blood cell count abnormal 82.49 9.50 82 117420 5050 46563510
Wound closure 80.04 9.50 26 117476 152 46568408
Pseudomembranous colitis 78.89 9.50 65 117437 3130 46565430
Dermatitis allergic 75.45 9.50 123 117379 12480 46556080
Off label use 73.81 9.50 607 116895 379234 46189326
Arthropathy 73.48 9.50 63 117439 84637 46483923
Meningitis aseptic 73.03 9.50 69 117433 3990 46564570
Palatal oedema 72.14 9.50 32 117470 479 46568081
Cholecystitis chronic 71.91 9.50 109 117393 10390 46558170
Hand deformity 70.73 9.50 4 117498 34570 46533990
Eyelid oedema 70.20 9.50 107 117395 10250 46558310
Cholestatic liver injury 70.12 9.50 51 117451 2039 46566521
Dermatitis exfoliative generalised 69.64 9.50 59 117443 2954 46565606
Therapeutic product effect incomplete 69.18 9.50 57 117445 78096 46490464
Osteotomy 68.61 9.50 26 117476 253 46568307
Mixed liver injury 65.47 9.50 58 117444 3085 46565475
Diarrhoea 65.45 9.50 1856 115646 557746 46010814
Injection site pain 64.82 9.50 106 117396 107046 46461514
Injection site erythema 63.78 9.50 56 117446 74371 46494189
Rash morbilliform 63.62 9.50 56 117446 2953 46565607
Liver injury 62.65 9.50 130 117372 15871 46552689
Hypersensitivity 60.43 9.50 611 116891 149710 46418850
Drug eruption 59.93 9.50 152 117350 21177 46547383
Synovitis 59.92 9.50 40 117462 61035 46507525
Myocardial infarction 59.43 9.50 96 117406 97432 46471128
Alopecia 58.41 9.50 211 117291 162203 46406357
Weight increased 58.27 9.50 215 117287 164258 46404302
Idiosyncratic drug reaction 57.53 9.50 32 117470 795 46567765
Paraesthesia oral 57.50 9.50 105 117397 11668 46556892
Breast cancer 54.67 9.50 23 117479 45495 46523065
Joint swelling 54.41 9.50 224 117278 165849 46402711
Loss of personal independence in daily activities 54.05 9.50 39 117463 57144 46511416
Hepatitis 53.79 9.50 191 117311 32024 46536536
Kounis syndrome 53.72 9.50 35 117467 1167 46567393
Sinusitis 51.44 9.50 526 116976 129242 46439318
Arthritis 50.08 9.50 73 117429 77243 46491317
Linear IgA disease 49.77 9.50 35 117467 1326 46567234
Bronchospasm 49.51 9.50 117 117385 15590 46552970
Pain in extremity 49.41 9.50 415 117087 258265 46310295
Treatment failure 48.38 9.50 101 117401 92986 46475574
Vascular purpura 47.80 9.50 34 117468 1312 46567248
Acute hepatic failure 45.69 9.50 109 117393 14612 46553948
Device expulsion 44.06 9.50 8 117494 27534 46541026
Klebsiella infection 43.98 9.50 68 117434 6594 46561966
Glossodynia 43.61 9.50 29 117473 44344 46524216
Dermatitis bullous 43.61 9.50 73 117429 7570 46560990
Chromaturia 43.20 9.50 108 117394 14911 46553649
Injection site swelling 42.92 9.50 24 117478 40303 46528257
Periorbital oedema 42.90 9.50 58 117444 4977 46563583
Agranulocytosis 42.73 9.50 138 117364 22047 46546513
Jaundice cholestatic 39.94 9.50 56 117446 4973 46563587
Odynophagia 39.85 9.50 65 117437 6597 46561963
Systemic lupus erythematosus 38.92 9.50 65 117437 65115 46503445
Product use issue 38.09 9.50 117 117385 94527 46474033
Basilar artery occlusion 38.00 9.50 14 117488 125 46568435
Symmetrical drug-related intertriginous and flexural exanthema 37.70 9.50 17 117485 265 46568295
Laryngeal oedema 37.53 9.50 56 117446 5263 46563297
Tooth demineralisation 37.29 9.50 9 117493 12 46568548
Cardiac failure congestive 37.22 9.50 113 117389 91637 46476923
Blood pressure increased 37.15 9.50 178 117324 126488 46442072
Hyperaemia 36.10 9.50 34 117468 1958 46566602
Tryptase increased 35.51 9.50 15 117487 198 46568362
Dermatitis exfoliative 34.50 9.50 56 117446 5660 46562900
Neutrophilia 34.50 9.50 40 117462 2937 46565623
Lymphadenopathy 34.29 9.50 171 117331 33317 46535243
Injection site pruritus 33.92 9.50 30 117472 39713 46528847
Wound 33.40 9.50 35 117467 42767 46525793
Platelet count decreased 33.31 9.50 134 117368 99890 46468670
Throat tightness 33.28 9.50 121 117381 20518 46548042
Ear infection 33.04 9.50 130 117372 22883 46545677
Injury 32.58 9.50 206 117296 43821 46524739
Hepatitis acute 32.46 9.50 67 117435 8147 46560413
Choluria 32.34 9.50 13 117489 150 46568410
Trimethylaminuria 31.88 9.50 13 117489 156 46568404
Pharyngeal swelling 31.77 9.50 41 117461 3362 46565198
Knee arthroplasty 31.73 9.50 10 117492 23655 46544905
Purpura 31.19 9.50 74 117428 9884 46558676
Blood glucose increased 30.43 9.50 87 117415 71926 46496634
Peritonsillar abscess 30.24 9.50 18 117484 510 46568050
Premature baby 29.90 9.50 107 117395 18005 46550555
Drug intolerance 29.83 9.50 232 117270 146817 46421743
Premature delivery 29.56 9.50 122 117380 21947 46546613
Staphylococcal scalded skin syndrome 29.28 9.50 12 117490 146 46568414
Contraindicated product administered 29.28 9.50 103 117399 79844 46488716
Drug interaction 29.22 9.50 693 116809 202401 46366159
Candida infection 29.05 9.50 122 117380 22118 46546442
Tooth infection 28.90 9.50 82 117420 12204 46556356
Diabetes mellitus 28.90 9.50 51 117451 50014 46518546
Lower respiratory tract infection 28.75 9.50 237 117265 54852 46513708
Pain 28.42 9.50 950 116552 475998 46092562
Hyperleukocytosis 28.32 9.50 16 117486 410 46568150
Wrong technique in product usage process 28.31 9.50 59 117443 54363 46514197
Isosthenuria 27.91 9.50 11 117491 120 46568440
Hallucinations, mixed 27.84 9.50 41 117461 3808 46564752
Vomiting 27.79 9.50 1399 116103 451395 46117165
Enanthema 27.14 9.50 16 117486 445 46568115
Hypertension 27.14 9.50 340 117162 196016 46372544
Moraxella test positive 26.93 9.50 7 117495 15 46568545
Skin exfoliation 26.83 9.50 158 117344 32780 46535780
International normalised ratio increased 26.82 9.50 206 117296 46677 46521883
Skin test positive 26.81 9.50 19 117483 729 46567831
Vitiligo 26.71 9.50 22 117480 1059 46567501
Foetal exposure during pregnancy 26.68 9.50 150 117352 30597 46537963
Injection site reaction 26.50 9.50 50 117452 47799 46520761
Mobility decreased 26.50 9.50 72 117430 60522 46508038
Abdominal discomfort 25.98 9.50 249 117253 150916 46417644
Localised oedema 25.76 9.50 46 117456 5023 46563537
Skin lesion 25.67 9.50 134 117368 26579 46541981
Emotional distress 25.46 9.50 148 117354 30559 46538001
Multiple sclerosis relapse 25.15 9.50 42 117460 42083 46526477
Lemierre syndrome 25.06 9.50 10 117492 113 46568447
Laryngeal discomfort 24.96 9.50 13 117489 282 46568278
Wheezing 24.88 9.50 224 117278 53162 46515398
Swelling of eyelid 24.85 9.50 22 117480 1169 46567391
Chronic kidney disease 24.74 9.50 182 117320 40689 46527871
Malaise 24.51 9.50 1043 116459 330189 46238371
Pyelitis 24.48 9.50 11 117491 170 46568390
Salpingo-oophorectomy unilateral 24.39 9.50 14 117488 370 46568190
Fluid retention 24.37 9.50 58 117444 50988 46517572
Injection site warmth 24.33 9.50 3 117499 13769 46554791
Pharyngeal oedema 24.32 9.50 86 117416 14385 46554175
Electrocardiogram PR shortened 24.31 9.50 11 117491 173 46568387
Headache 24.17 9.50 972 116530 477380 46091180
Faeces pale 24.14 9.50 24 117478 1478 46567082
Fibromyalgia 24.03 9.50 34 117468 36429 46532131
Fracture 23.86 9.50 6 117496 16465 46552095
Drug abuse 23.69 9.50 81 117421 63327 46505233
Cardio-respiratory arrest 23.38 9.50 75 117427 59794 46508766
Erythromelalgia 23.34 9.50 10 117492 137 46568423
Peripheral circulatory failure 23.23 9.50 13 117489 327 46568233
Tongue discolouration 23.19 9.50 33 117469 2971 46565589
Exposure during pregnancy 23.17 9.50 392 117110 107820 46460740
Dental operation 23.08 9.50 21 117481 1157 46567403
Disease progression 23.02 9.50 135 117367 91165 46477395
Pericarditis 23.02 9.50 16 117486 23911 46544649
Somatic delusion 22.97 9.50 16 117486 597 46567963
Intentional product misuse 22.94 9.50 53 117449 47075 46521485
Infectious mononucleosis 22.92 9.50 24 117478 1572 46566988
Leukocytosis 22.92 9.50 118 117384 23280 46545280
Bladder hypertrophy 22.34 9.50 11 117491 211 46568349
Rash pustular 22.26 9.50 52 117450 6877 46561683
Sinusitis fungal 21.97 9.50 18 117484 860 46567700
Mental status changes 21.80 9.50 39 117463 38049 46530511
Oral discomfort 21.79 9.50 56 117446 7862 46560698
Protein C increased 21.67 9.50 10 117492 165 46568395
Haemolytic anaemia 21.53 9.50 64 117438 9778 46558782
Therapeutic response decreased 21.42 9.50 48 117454 43097 46525463
Transaminases increased 21.23 9.50 131 117371 27630 46540930
Oliguria 21.13 9.50 59 117443 8700 46559860
Respiratory symptom 21.01 9.50 26 117476 2044 46566516
Malignant neoplasm progression 20.97 9.50 88 117414 64838 46503722
Tonsillar exudate 20.95 9.50 6 117496 21 46568539
Renal papillary necrosis 20.90 9.50 11 117491 244 46568316
Gastrointestinal haemorrhage 20.81 9.50 112 117390 77261 46491299
Haematuria 20.70 9.50 127 117375 26731 46541829
Product complaint 20.51 9.50 3 117499 12098 46556462
Distributive shock 20.47 9.50 14 117488 507 46568053
Hip arthroplasty 20.42 9.50 10 117492 18102 46550458
Pharyngitis streptococcal 20.39 9.50 57 117445 8411 46560149
Rash papular 20.28 9.50 75 117427 12823 46555737
Empyema 20.23 9.50 24 117478 1806 46566754
Conjunctival hyperaemia 20.21 9.50 25 117477 1964 46566596
Eye swelling 20.12 9.50 102 117400 20001 46548559
Injection site bruising 19.94 9.50 37 117465 35599 46532961
Influenza B virus test positive 19.73 9.50 12 117490 354 46568206
Conjunctivitis 19.67 9.50 84 117418 15340 46553220
Blood cholesterol increased 19.47 9.50 45 117457 39968 46528592
Viral parotitis 19.47 9.50 5 117497 10 46568550
Inappropriate schedule of product administration 19.26 9.50 91 117411 64922 46503638
Eosinophilic pneumonia 19.06 9.50 24 117478 1920 46566640
Tonsillitis 19.04 9.50 40 117462 4924 46563636
Product dose omission issue 18.96 9.50 304 117198 168216 46400344
Cell death 18.95 9.50 26 117476 2262 46566298
Normal tension glaucoma 18.67 9.50 7 117495 66 46568494
Incorrect route of product administration 18.54 9.50 9 117493 16374 46552186
Nausea 18.52 9.50 1485 116017 685969 45882591
Otitis media 18.45 9.50 36 117466 4204 46564356
Tongue coated 18.34 9.50 19 117483 1229 46567331
Foetal non-stress test abnormal 18.34 9.50 6 117496 36 46568524
Pharyngotonsillitis 18.26 9.50 9 117493 173 46568387
Contraindicated product prescribed 18.17 9.50 15 117487 724 46567836
Hypertransaminasaemia 18.17 9.50 32 117470 3456 46565104
Biliary colic 18.10 9.50 32 117470 3466 46565094
Fixed eruption 18.09 9.50 16 117486 849 46567711
Pharyngeal erythema 18.09 9.50 21 117481 1544 46567016
Lymphocytosis 17.93 9.50 25 117477 2209 46566351
Mania 17.84 9.50 64 117438 10782 46557778
Underdose 17.63 9.50 14 117488 19544 46549016
Joint range of motion decreased 17.59 9.50 8 117494 15116 46553444
Red blood cell sedimentation rate increased 17.54 9.50 19 117483 22870 46545690
Hepatic enzyme increased 17.54 9.50 127 117375 81660 46486900
Pharyngeal paraesthesia 17.53 9.50 18 117484 1152 46567408
Cheilitis 17.52 9.50 34 117468 3954 46564606
Depression 17.46 9.50 312 117190 169792 46398768
Neisseria infection 17.43 9.50 6 117496 43 46568517
Hyperthermia 17.42 9.50 52 117450 7962 46560598
Psychotic symptom 17.39 9.50 16 117486 894 46567666
Faeces discoloured 17.38 9.50 86 117416 16701 46551859
Medication crystals in urine present 17.19 9.50 4 117498 4 46568556
Dyspnoea 17.17 9.50 1513 115989 514035 46054525
Femur fracture 16.90 9.50 43 117459 36954 46531606
Rash vesicular 16.90 9.50 31 117471 3456 46565104
Mouth swelling 16.88 9.50 32 117470 3657 46564903
Oral candidiasis 16.88 9.50 88 117414 17444 46551116
Megacolon 16.78 9.50 21 117481 1670 46566890
Blood pressure fluctuation 16.70 9.50 32 117470 30416 46538144
Gait disturbance 16.69 9.50 261 117241 145002 46423558
Tinnitus 16.61 9.50 123 117379 27550 46541010
Pyogenic granuloma 16.53 9.50 10 117492 292 46568268
Balance disorder 16.48 9.50 95 117407 64426 46504134
Multiple sclerosis 16.45 9.50 23 117479 24768 46543792
Pneumonia mycoplasmal 16.38 9.50 15 117487 833 46567727
Periorbital cellulitis 16.32 9.50 12 117490 488 46568072
Respiratory tract infection 16.20 9.50 130 117372 29842 46538718
Sputum increased 16.15 9.50 21 117481 1735 46566825
Medication error 16.13 9.50 133 117369 30778 46537782
Back pain 16.07 9.50 404 117098 209635 46358925
Injection site rash 15.99 9.50 10 117492 15803 46552757
Periorbital swelling 15.99 9.50 18 117484 1280 46567280
Phaeohyphomycosis 15.85 9.50 9 117493 233 46568327
Skin reaction 15.85 9.50 62 117440 10884 46557676
Embolism venous 15.73 9.50 25 117477 2482 46566078
Fulminant type 1 diabetes mellitus 15.51 9.50 9 117493 243 46568317
Suicidal ideation 15.50 9.50 81 117421 56301 46512259
Musculoskeletal pain 15.47 9.50 108 117394 70020 46498540
Psoriasis 15.47 9.50 125 117377 78479 46490081
Ankle fracture 15.42 9.50 10 117492 15501 46553059
Herpes zoster 15.23 9.50 104 117398 67768 46500792
Osteoporosis 15.08 9.50 52 117450 40556 46528004
Bipolar I disorder 15.02 9.50 19 117483 1527 46567033
Yellow skin 14.95 9.50 22 117480 2042 46566518
Induced abortion failed 14.93 9.50 9 117493 261 46568299
Abnormal faeces 14.81 9.50 32 117470 4017 46564543
Eczema 14.81 9.50 95 117407 20305 46548255
Joint injury 14.66 9.50 16 117486 19193 46549367
Discomfort 14.61 9.50 64 117438 46606 46521954
White blood cell count decreased 14.51 9.50 197 117305 112034 46456526
Upper limb fracture 14.48 9.50 11 117491 15702 46552858
Peripheral swelling 14.36 9.50 296 117206 157775 46410785
Memory impairment 14.31 9.50 125 117377 77212 46491348
Chronic sinusitis 14.27 9.50 36 117466 4997 46563563
Bradycardia 14.19 9.50 103 117399 66195 46502365
Blood glucose decreased 14.13 9.50 16 117486 18876 46549684
Mucosal inflammation 14.02 9.50 155 117347 38821 46529739
Thermal burn 13.95 9.50 35 117467 4842 46563718
Feeling abnormal 13.93 9.50 226 117276 124834 46443726
Pericardial effusion 13.87 9.50 27 117475 25516 46543044
Norovirus test positive 13.82 9.50 7 117495 143 46568417
Neoplasm progression 13.81 9.50 29 117473 26654 46541906
Systemic inflammatory response syndrome 13.78 9.50 37 117465 5334 46563226
Live birth 13.75 9.50 57 117445 10273 46558287
Ecthyma 13.72 9.50 8 117494 218 46568342
Amnesia 13.71 9.50 56 117446 41575 46526985
Respiratory depression 13.70 9.50 6 117496 11594 46556966
Pharyngeal abscess 13.69 9.50 8 117494 219 46568341
Deafness 13.68 9.50 78 117424 15990 46552570
Anuria 13.62 9.50 61 117441 11370 46557190
Cerebrovascular accident 13.55 9.50 176 117326 100863 46467697
Accidental exposure to product 13.55 9.50 20 117482 21061 46547499
Overdose 13.55 9.50 178 117324 101801 46466759
Diastasis recti abdominis 13.54 9.50 5 117497 45 46568515
Blood count abnormal 13.52 9.50 15 117487 17863 46550697
Metastases to lung 13.51 9.50 5 117497 10691 46557869
Prothrombin time ratio decreased 13.49 9.50 10 117492 412 46568148
Pulmonary artery stenosis congenital 13.46 9.50 8 117494 226 46568334
Parotid gland enlargement 13.34 9.50 13 117489 781 46567779
Dysbiosis 13.33 9.50 11 117491 531 46568029
Depressed level of consciousness 13.27 9.50 68 117434 47501 46521059
Bronchopleural fistula 13.21 9.50 8 117494 234 46568326
Progressive multifocal leukoencephalopathy 13.20 9.50 6 117496 11340 46557220
Eosinophils urine present 13.18 9.50 4 117498 18 46568542
Urea urine increased 13.18 9.50 4 117498 18 46568542
Drug withdrawal syndrome 13.16 9.50 31 117471 27353 46541207
Prothrombin time shortened 13.11 9.50 19 117483 1740 46566820
Femoral artery embolism 12.99 9.50 5 117497 51 46568509
Dyskinesia 12.92 9.50 34 117468 28891 46539669
Arthritis allergic 12.89 9.50 3 117499 3 46568557
Biliary sepsis 12.86 9.50 11 117491 558 46568002
Labelled drug-drug interaction medication error 12.86 9.50 51 117451 9010 46559550
Cholestasis of pregnancy 12.85 9.50 15 117487 1109 46567451
Peritonitis bacterial 12.83 9.50 3 117499 8650 46559910
Hip fracture 12.81 9.50 30 117472 26526 46542034
Erythema nodosum 12.81 9.50 29 117473 3757 46564803
Fear-related avoidance of activities 12.79 9.50 6 117496 103 46568457
Foetal hypokinesia 12.76 9.50 10 117492 448 46568112
Pulmonary hypertension 12.76 9.50 47 117455 35946 46532614
Coronary artery disease 12.68 9.50 43 117459 33709 46534851
Caffeine allergy 12.67 9.50 4 117498 21 46568539
Sedation 12.63 9.50 24 117478 22886 46545674
Oedema 12.58 9.50 238 117264 66833 46501727
Dysphonia 12.58 9.50 150 117352 38264 46530296
Adverse event 12.54 9.50 44 117458 34140 46534420
Tangentiality 12.52 9.50 4 117498 22 46568538
Duodenal ulcer perforation 12.51 9.50 3 117499 8499 46560061
Toothache 12.50 9.50 78 117424 16514 46552046
Polymenorrhagia 12.49 9.50 5 117497 57 46568503
Syncope 12.47 9.50 187 117315 104616 46463944
Nasal polyps 12.46 9.50 21 117481 2189 46566371
Lower respiratory tract infection bacterial 12.46 9.50 9 117493 356 46568204
Gait inability 12.46 9.50 46 117456 35157 46533403
Excessive eye blinking 12.43 9.50 11 117491 584 46567976
Lymphadenitis 12.42 9.50 23 117479 2582 46565978
Gallbladder disorder 12.40 9.50 81 117421 17417 46551143
Acute haemorrhagic oedema of infancy 12.37 9.50 4 117498 23 46568537
Cardiac failure 12.36 9.50 135 117367 79813 46488747
Circulatory collapse 12.35 9.50 95 117407 21529 46547031
Restless legs syndrome 12.31 9.50 13 117489 15830 46552730
Gastric disorder 12.23 9.50 31 117471 26674 46541886
Abdominal pain upper 12.20 9.50 464 117038 144841 46423719
Metastases to liver 12.18 9.50 19 117483 19566 46548994
Creatinine renal clearance increased 12.18 9.50 10 117492 479 46568081
Sebaceous gland infection 12.14 9.50 6 117496 116 46568444
Myelodysplastic syndrome 12.08 9.50 13 117489 15698 46552862
Injury corneal 12.05 9.50 5 117497 63 46568497
Budd-Chiari syndrome 12.05 9.50 5 117497 63 46568497
Otitis media acute 11.98 9.50 13 117489 887 46567673
C-reactive protein abnormal 11.97 9.50 22 117480 21248 46547312
Clostridium test positive 11.97 9.50 19 117483 1885 46566675
Pulmonary arterial hypertension 11.95 9.50 30 117472 25898 46542662
Atrial fibrillation 11.93 9.50 186 117316 103404 46465156
Abdominal pain 11.92 9.50 700 116802 229331 46339229
Pseudomyopia 11.91 9.50 5 117497 65 46568495
Device issue 11.85 9.50 20 117482 19960 46548600
Visual impairment 11.81 9.50 109 117393 66580 46501980
Neoplasm malignant 11.78 9.50 26 117476 23473 46545087
Laryngeal obstruction 11.70 9.50 4 117498 28 46568532
Prescribed underdose 11.68 9.50 8 117494 12045 46556515
Oropharyngeal discomfort 11.67 9.50 25 117477 3120 46565440
Right ventricular failure 11.63 9.50 14 117488 16079 46552481
Neonatal respiratory distress syndrome 11.63 9.50 22 117480 2511 46566049
Product colour issue 11.58 9.50 11 117491 640 46567920
Actinomycosis 11.58 9.50 14 117488 1074 46567486
Forced vital capacity abnormal 11.58 9.50 4 117498 29 46568531
Palatal swelling 11.57 9.50 5 117497 70 46568490
Anaemia 11.55 9.50 526 116976 255253 46313307
Lip pain 11.53 9.50 18 117484 1760 46566800
Cataract 11.52 9.50 67 117435 45348 46523212
Injection site urticaria 11.52 9.50 8 117494 11959 46556601
Laryngeal dyspnoea 11.48 9.50 6 117496 131 46568429
Bone pain 11.46 9.50 70 117432 46820 46521740
Sweat discolouration 11.37 9.50 3 117499 7 46568553
Status epilepticus 11.34 9.50 67 117435 13912 46554648
Inhibitory drug interaction 11.31 9.50 19 117483 1976 46566584
Liver function test abnormal 11.29 9.50 172 117330 46315 46522245
Tooth discolouration 11.29 9.50 12 117490 800 46567760
Serotonin syndrome 11.18 9.50 28 117474 24192 46544368
Macroglossia 11.16 9.50 10 117492 540 46568020
Blood test abnormal 11.13 9.50 5 117497 9515 46559045
Non-alcoholic steatohepatitis 11.11 9.50 16 117486 1456 46567104
Congenital tricuspid valve incompetence 11.09 9.50 5 117497 78 46568482
Septic pulmonary embolism 11.03 9.50 4 117498 34 46568526
Uveitis 10.98 9.50 4 117498 8637 46559923
Muscle necrosis 10.94 9.50 10 117492 554 46568006
Gingival swelling 10.94 9.50 28 117474 3922 46564638
Ureteric dilatation 10.93 9.50 4 117498 35 46568525
Infusion site nodule 10.93 9.50 13 117489 981 46567579
Reaction to excipient 10.92 9.50 14 117488 1140 46567420
Weight decreased 10.91 9.50 427 117075 210422 46358138
Veillonella infection 10.83 9.50 4 117498 36 46568524
Glycosylated haemoglobin increased 10.83 9.50 7 117495 10869 46557691
Blood catecholamines abnormal 10.83 9.50 3 117499 9 46568551
Delusion of grandeur 10.83 9.50 6 117496 148 46568412
Mucosal discolouration 10.81 9.50 9 117493 440 46568120
Abdominal wall haematoma 10.80 9.50 23 117479 2858 46565702
Cerebral infarction 10.80 9.50 27 117475 23339 46545221
Genital erosion 10.75 9.50 6 117496 150 46568410
Delayed delivery 10.73 9.50 4 117498 37 46568523
Pneumonia aspiration 10.73 9.50 42 117460 31563 46536997
Tongue pruritus 10.67 9.50 9 117493 448 46568112
Tongue exfoliation 10.65 9.50 5 117497 86 46568474
Subacute hepatic failure 10.61 9.50 6 117496 154 46568406
Impaired healing 10.55 9.50 52 117450 36691 46531869
Foot deformity 10.55 9.50 14 117488 15411 46553149
Hypothyroidism 10.41 9.50 42 117460 31296 46537264
Factor V inhibition 10.37 9.50 6 117496 161 46568399
Lip erythema 10.29 9.50 5 117497 93 46568467
Poor quality sleep 10.27 9.50 14 117488 15239 46553321
Pneumocystis jirovecii pneumonia 10.26 9.50 14 117488 15234 46553326
Flank pain 10.26 9.50 58 117444 11855 46556705
Biliary dyskinesia 10.24 9.50 22 117480 2751 46565809
Polyneuropathy 10.23 9.50 57 117445 11587 46556973
Behaviour disorder 10.23 9.50 18 117484 1943 46566617
Maternal exposure during breast feeding 10.15 9.50 22 117480 2767 46565793
Psoriatic arthropathy 10.15 9.50 52 117450 36327 46532233
Rheumatoid nodule 10.14 9.50 5 117497 9015 46559545
Stomatococcal infection 10.10 9.50 5 117497 97 46568463
Monoclonal gammopathy 10.04 9.50 10 117492 617 46567943
Foetal distress syndrome 10.02 9.50 14 117488 1239 46567321
Palmar-plantar erythrodysaesthesia syndrome 9.95 9.50 23 117479 20428 46548132
Somnolence 9.93 9.50 309 117193 156212 46412348
Sleep disorder 9.87 9.50 73 117429 46722 46521838
Glomerulonephritis acute 9.81 9.50 4 117498 48 46568512
Ureteric obstruction 9.78 9.50 17 117485 1817 46566743
Pruritus genital 9.78 9.50 10 117492 637 46567923
Upper respiratory tract infection 9.77 9.50 219 117283 63337 46505223
Rhabdomyolysis 9.77 9.50 154 117348 41755 46526805
Therapy non-responder 9.77 9.50 62 117440 41090 46527470
Pneumopericardium 9.74 9.50 4 117498 49 46568511
Genital prolapse 9.66 9.50 4 117498 50 46568510
Respiratory gas exchange disorder 9.66 9.50 8 117494 388 46568172
Helicobacter test positive 9.64 9.50 8 117494 389 46568171
Incorrect dose administered 9.63 9.50 71 117431 45479 46523081
Intentional self-injury 9.62 9.50 30 117472 24136 46544424
Coagulation factor deficiency 9.62 9.50 3 117499 15 46568545
Gamma-glutamyltransferase increased 9.55 9.50 122 117380 31618 46536942
Nasopharyngitis 9.53 9.50 305 117197 153693 46414867
Hemianopia homonymous 9.52 9.50 10 117492 657 46567903

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 reaction with eosinophilia and systemic symptoms 540.63 9.84 520 82432 27968 29841558
Anaphylactic shock 466.22 9.84 353 82599 13640 29855886
Pruritus 451.31 9.84 1004 81948 117200 29752326
Rash maculo-papular 437.59 9.84 440 82512 24978 29844548
Urticaria 384.88 9.84 604 82348 54002 29815524
Cholestasis 295.58 9.84 355 82597 24595 29844931
Hepatocellular injury 289.68 9.84 355 82597 25116 29844410
Anaphylactic reaction 277.08 9.84 364 82588 27618 29841908
Erythema 266.49 9.84 632 82320 76819 29792707
Rash 266.06 9.84 1143 81809 190746 29678780
Acute generalised exanthematous pustulosis 258.27 9.84 178 82774 5920 29863606
Eosinophilia 257.08 9.84 312 82640 21848 29847678
Drug hypersensitivity 239.88 9.84 563 82389 67956 29801570
Meningitis aseptic 208.83 9.84 110 82842 2212 29867314
Hepatitis cholestatic 207.28 9.84 173 82779 7699 29861827
Death 207.26 9.84 425 82527 356858 29512668
Lip oedema 204.10 9.84 107 82845 2130 29867396
Drug-induced liver injury 198.68 9.84 269 82683 21005 29848521
Angioedema 197.31 9.84 347 82605 34037 29835489
Kounis syndrome 181.67 9.84 90 82862 1583 29867943
Completed suicide 156.76 9.84 41 82911 99451 29770075
Mixed liver injury 144.83 9.84 82 82870 1911 29867615
Acute kidney injury 135.50 9.84 1252 81700 272590 29596936
Toxic epidermal necrolysis 135.38 9.84 205 82747 17735 29851791
Face oedema 132.08 9.84 160 82792 11174 29858352
Type I hypersensitivity 130.39 9.84 60 82892 888 29868638
Stevens-Johnson syndrome 123.21 9.84 194 82758 17362 29852164
Lip swelling 117.22 9.84 160 82792 12584 29856942
Toxicity to various agents 109.03 9.84 203 82749 176980 29692546
Toxic skin eruption 105.43 9.84 141 82811 10874 29858652
Type IV hypersensitivity reaction 99.32 9.84 53 82899 1095 29868431
Hepatitis acute 97.60 9.84 109 82843 6974 29862552
Jaundice 93.58 9.84 248 82704 32238 29837288
Enterocolitis haemorrhagic 89.89 9.84 47 82905 930 29868596
Hypersensitivity 89.74 9.84 341 82611 53687 29815839
Hepatitis 89.59 9.84 194 82758 22162 29847364
Fixed eruption 86.80 9.84 49 82903 1135 29868391
Clostridium difficile colitis 86.70 9.84 139 82813 12629 29856897
Rash erythematous 84.51 9.84 190 82762 22262 29847264
Pyrexia 81.47 9.84 1204 81748 293285 29576241
Myocardial infarction 78.92 9.84 142 82810 125483 29744043
Dermatitis exfoliative generalised 78.55 9.84 64 82888 2751 29866775
Erythema multiforme 77.62 9.84 103 82849 7882 29861644
Wound closure 76.26 9.84 24 82928 111 29869415
Idiosyncratic drug reaction 76.22 9.84 34 82918 466 29869060
Fall 74.80 9.84 256 82696 181616 29687910
Osteotomy 74.09 9.84 24 82928 124 29869402
Tongue oedema 72.97 9.84 61 82891 2719 29866807
Documented hypersensitivity to administered product 72.44 9.84 26 82926 192 29869334
Eyelid oedema 68.42 9.84 77 82875 4968 29864558
Cardiac failure congestive 67.05 9.84 81 82871 84326 29785200
Crystalluria 64.72 9.84 28 82924 355 29869171
Rash morbilliform 63.82 9.84 54 82898 2448 29867078
Liver injury 62.04 9.84 118 82834 12282 29857244
Jaundice cholestatic 60.93 9.84 69 82883 4482 29865044
Drug abuse 59.80 9.84 84 82868 81988 29787538
Tubulointerstitial nephritis 58.17 9.84 143 82809 17748 29851778
Bronchospasm 57.53 9.84 103 82849 10235 29859291
Cholestatic liver injury 56.88 9.84 42 82910 1559 29867967
Rash pruritic 55.79 9.84 163 82789 22409 29847117
Fatigue 54.10 9.84 598 82354 320075 29549451
Malignant neoplasm progression 53.65 9.84 73 82879 72214 29797312
Cerebrovascular accident 53.61 9.84 93 82859 83384 29786142
Serum sickness-like reaction 52.14 9.84 17 82935 90 29869436
Palatal oedema 51.46 9.84 30 82922 740 29868786
Rash pustular 51.11 9.84 66 82886 4917 29864609
Acute psychosis 50.98 9.84 42 82910 1834 29867692
Faeces pale 50.80 9.84 38 82914 1439 29868087
Swelling face 49.44 9.84 150 82802 21054 29848472
Agranulocytosis 48.18 9.84 152 82800 21790 29847736
Purpura 46.38 9.84 92 82860 9875 29859651
Swollen tongue 45.62 9.84 108 82844 13084 29856442
Disease progression 45.17 9.84 96 82856 79778 29789748
Rash macular 42.71 9.84 91 82861 10276 29859250
Clostridium difficile infection 41.94 9.84 117 82835 15666 29853860
Rheumatoid arthritis 41.45 9.84 32 82920 41165 29828361
Hypersensitivity vasculitis 40.85 9.84 51 82901 3672 29865854
Mouth swelling 39.74 9.84 34 82918 1565 29867961
Lower respiratory tract infection 39.00 9.84 162 82790 26552 29842974
Henoch-Schonlein purpura 37.92 9.84 32 82920 1445 29868081
Dermatitis bullous 36.80 9.84 63 82889 6041 29863485
Sensation of foreign body 36.21 9.84 31 82921 1428 29868098
Chromaturia 36.07 9.84 102 82850 13763 29855763
Premature baby 36.07 9.84 115 82837 16576 29852950
Weight increased 35.29 9.84 99 82853 74814 29794712
Vomiting 34.81 9.84 825 82127 218993 29650533
Helicobacter gastritis 34.21 9.84 24 82928 821 29868705
Laryngeal oedema 34.15 9.84 44 82908 3270 29866256
Therapeutic product effect decreased 34.11 9.84 19 82933 29057 29840469
Inflammatory marker increased 33.91 9.84 43 82909 3145 29866381
Tooth disorder 33.87 9.84 77 82875 9084 29860442
Conjunctivitis 33.86 9.84 71 82881 7929 29861597
Mononucleosis syndrome 33.31 9.84 11 82941 61 29869465
Platelet count decreased 33.18 9.84 166 82786 105963 29763563
Dizziness 32.95 9.84 363 82589 194546 29674980
Hypertension 32.91 9.84 199 82753 121155 29748371
Cerebral infarction 32.76 9.84 16 82936 26357 29843169
Cell death 32.58 9.84 36 82916 2275 29867251
Injection site pain 32.51 9.84 22 82930 30288 29839238
Blood glucose increased 32.29 9.84 77 82875 61453 29808073
Helicobacter infection 32.07 9.84 34 82918 2050 29867476
Drug eruption 31.90 9.84 114 82838 17412 29852114
Sinusitis 31.86 9.84 179 82773 33166 29836360
Tooth demineralisation 31.76 9.84 7 82945 3 29869523
Crystal nephropathy 31.10 9.84 17 82935 369 29869157
Prothrombin time shortened 30.62 9.84 29 82923 1526 29868000
Coronary artery disease 30.45 9.84 57 82895 49655 29819871
Dermatitis allergic 30.20 9.84 56 82896 5716 29863810
Eosinophilic pleural effusion 30.02 9.84 14 82938 214 29869312
Laryngeal dyspnoea 29.91 9.84 10 82942 58 29869468
Depression 29.69 9.84 139 82813 90298 29779228
Pathogen resistance 29.24 9.84 69 82883 8341 29861185
Skin test positive 28.96 9.84 16 82936 355 29869171
Haemoglobin decreased 28.93 9.84 191 82761 113907 29755619
Blood creatine phosphokinase increased 28.92 9.84 48 82904 43800 29825726
Rash vesicular 28.89 9.84 35 82917 2443 29867083
Wheezing 28.85 9.84 165 82787 30773 29838753
Epstein-Barr virus infection reactivation 28.79 9.84 14 82938 236 29869290
Cheilitis 28.17 9.84 33 82919 2223 29867303
Aortitis 28.03 9.84 12 82940 148 29869378
Oxygen saturation immeasurable 28.03 9.84 9 82943 45 29869481
Rash papular 27.99 9.84 69 82883 8576 29860950
Tooth infection 27.96 9.84 51 82901 5140 29864386
Tachycardia foetal 27.84 9.84 15 82937 316 29869210
Malaise 27.74 9.84 631 82321 166331 29703195
Drug intolerance 27.68 9.84 52 82900 45239 29824287
Factitious disorder 27.55 9.84 9 82943 48 29869478
Sensitisation 27.26 9.84 12 82940 159 29869367
Conjunctival irritation 26.98 9.84 11 82941 119 29869407
Otospondylomegaepiphyseal dysplasia 26.81 9.84 11 82941 121 29869405
Periorbital oedema 26.50 9.84 39 82913 3287 29866239
Aphthous ulcer 25.30 9.84 43 82909 4098 29865428
Pain 25.16 9.84 332 82620 172309 29697217
Angina pectoris 24.86 9.84 27 82925 29491 29840035
White blood cell count decreased 24.71 9.84 134 82818 83813 29785713
Wrong technique in product usage process 24.61 9.84 30 82922 31125 29838401
Deficiency of bile secretion 24.60 9.84 7 82945 21 29869505
Hypersensitivity myocarditis 24.56 9.84 9 82943 71 29869455
Rash scarlatiniform 24.54 9.84 10 82942 108 29869418
Product dose omission issue 24.44 9.84 151 82801 91480 29778046
Malignant mesenteric neoplasm 24.28 9.84 8 82944 44 29869482
Mental status changes 24.07 9.84 41 82911 37038 29832488
Loss of personal independence in daily activities 23.95 9.84 15 82937 21520 29848006
Macroglossia 23.92 9.84 12 82940 217 29869309
Ureteral disorder 23.36 9.84 11 82941 172 29869354
Heart rate decreased 22.83 9.84 15 82937 20979 29848547
Foetal disorder 22.79 9.84 17 82935 641 29868885
Escherichia infection 22.76 9.84 53 82899 6352 29863174
Irregular breathing 22.75 9.84 10 82942 132 29869394
Infusion related reaction 22.71 9.84 49 82903 40515 29829011
Hyperaemia 22.61 9.84 20 82932 963 29868563
Foetal exposure during pregnancy 22.51 9.84 177 82775 36694 29832832
Acute hepatic failure 22.45 9.84 78 82874 11749 29857777
Pain in extremity 22.05 9.84 197 82755 110024 29759502
Conjunctival hyperaemia 21.66 9.84 29 82923 2238 29867288
Gut fermentation syndrome 21.60 9.84 6 82946 16 29869510
Diarrhoea 21.19 9.84 1129 81823 332974 29536552
Attention-seeking behaviour 21.17 9.84 7 82945 39 29869487
Penile erythema 21.14 9.84 10 82942 158 29869368
Hyperbilirubinaemia 21.12 9.84 98 82854 16844 29852682
Jejunal ulcer perforation 21.11 9.84 8 82944 70 29869456
Neutropenia neonatal 21.06 9.84 15 82937 526 29869000
Deep vein thrombosis 21.04 9.84 91 82861 60410 29809116
Asthenia 21.02 9.84 460 82492 220830 29648696
Intentional product misuse 21.01 9.84 40 82912 34627 29834899
Ear infection 20.92 9.84 56 82896 7318 29862208
Mite allergy 20.84 9.84 11 82941 222 29869304
Metastases to stomach 20.72 9.84 8 82944 74 29869452
Cardio-respiratory arrest 20.67 9.84 85 82867 57221 29812305
Alice in wonderland syndrome 20.61 9.84 6 82946 20 29869506
Dyspnoea 20.49 9.84 1123 81829 332172 29537354
Choluria 20.49 9.84 10 82942 170 29869356
Dental operation 20.27 9.84 13 82939 382 29869144
Erysipelas 20.14 9.84 41 82911 4483 29865043
Dysbiosis 20.00 9.84 13 82939 391 29869135
Ultrasound liver abnormal 19.94 9.84 9 82943 127 29869399
Skin exfoliation 19.93 9.84 121 82831 23051 29846475
Seizure 19.70 9.84 176 82776 98299 29771227
Bradycardia 19.61 9.84 104 82848 65422 29804104
Pharyngeal erythema 19.50 9.84 14 82938 497 29869029
Dermatomyositis 19.42 9.84 19 82933 1041 29868485
Transaminases increased 19.24 9.84 121 82831 23336 29846190
Hyperleukocytosis 19.21 9.84 23 82929 1586 29867940
Oropharyngeal pain 19.19 9.84 140 82812 28356 29841170
Haematocrit decreased 18.97 9.84 35 82917 30664 29838862
Skin reaction 18.96 9.84 40 82912 4485 29865041
Odynophagia 18.95 9.84 40 82912 4487 29865039
Headache 18.76 9.84 374 82578 181932 29687594
Genital erythema 18.71 9.84 9 82943 148 29869378
Omental necrosis 18.68 9.84 6 82946 30 29869496
Eastern Cooperative Oncology Group performance status 18.68 9.84 6 82946 30 29869496
Procalcitonin increased 18.57 9.84 19 82933 1099 29868427
Ischaemic stroke 18.57 9.84 11 82941 16264 29853262
Drug dependence 18.46 9.84 19 82933 21276 29848250
Breath sounds 18.37 9.84 5 82947 12 29869514
Substance-induced mood disorder 18.37 9.84 5 82947 12 29869514
Constipation 18.36 9.84 212 82740 112694 29756832
Enterocolitis 18.19 9.84 50 82902 6637 29862889
Morganella infection 18.12 9.84 12 82940 373 29869153
Tissue infiltration 18.01 9.84 7 82945 66 29869460
Orthostatic hypotension 17.99 9.84 24 82928 23955 29845571
Skin oedema 17.96 9.84 14 82938 564 29868962
Bone disorder 17.93 9.84 50 82902 6691 29862835
Eosinophilic pneumonia acute 17.93 9.84 13 82939 469 29869057
Mycotic allergy 17.68 9.84 9 82943 168 29869358
Linear IgA disease 17.66 9.84 22 82930 1580 29867946
Faeces discoloured 17.62 9.84 81 82871 13865 29855661
Off label use 17.37 9.84 542 82410 248748 29620778
Lichenoid keratosis 17.33 9.84 25 82927 2069 29867457
Pharyngeal oedema 17.22 9.84 48 82904 6423 29863103
Papule 17.15 9.84 31 82921 3102 29866424
Hyperglycaemia 16.95 9.84 46 82906 35154 29834372
Blood pressure increased 16.93 9.84 123 82829 71805 29797721
Spinal muscular atrophy 16.90 9.84 9 82943 185 29869341
Genital cyst 16.81 9.84 4 82948 4 29869522
Plica syndrome 16.81 9.84 4 82948 4 29869522
Food intolerance 16.77 9.84 18 82934 1101 29868425
Neutrophil count decreased 16.57 9.84 61 82891 42393 29827133
Pharyngitis 16.51 9.84 49 82903 6793 29862733
Unresponsive to stimuli 16.43 9.84 30 82922 26389 29843137
Coagulation factor decreased 16.38 9.84 7 82945 86 29869440
Macule 16.35 9.84 16 82936 877 29868649
Vanishing bile duct syndrome 16.19 9.84 14 82938 654 29868872
Tachypnoea 16.13 9.84 83 82869 14869 29854657
Metastases to heart 16.13 9.84 8 82944 141 29869385
Laryngeal discomfort 15.98 9.84 8 82944 144 29869382
Hypocoagulable state 15.93 9.84 16 82936 905 29868621
Hypertransaminasaemia 15.88 9.84 34 82918 3851 29865675
Blood creatinine increased 15.87 9.84 169 82783 91206 29778320
Cerebral haemorrhage 15.82 9.84 43 82909 32844 29836682
Diabetes mellitus 15.79 9.84 61 82891 41804 29827722
Tongue eruption 15.54 9.84 4 82948 7 29869519
Melanocytic hyperplasia 15.54 9.84 4 82948 7 29869519
Drug ineffective 15.47 9.84 778 82174 339609 29529917
Synovitis 15.45 9.84 4 82948 9779 29859747
Granulomatous dermatitis 15.40 9.84 9 82943 223 29869303
Maple syrup disease 15.20 9.84 4 82948 8 29869518
Ototoxicity 15.12 9.84 19 82933 1377 29868149
Rectal polyp 14.98 9.84 13 82939 610 29868916
Inappropriate schedule of product administration 14.91 9.84 58 82894 39670 29829856
Sedation 14.90 9.84 14 82938 16359 29853167
Dermatitis 14.85 9.84 53 82899 8089 29861437
Maternal exposure during pregnancy 14.83 9.84 33 82919 3838 29865688
Antinuclear antibody negative 14.81 9.84 5 82947 30 29869496
Anaemia 14.77 9.84 451 82501 207541 29661985
Drug withdrawal syndrome 14.69 9.84 20 82932 19789 29849737
Intercostal neuralgia 14.68 9.84 3 82949 0 29869526
Toxocariasis 14.68 9.84 3 82949 0 29869526
Hepatic function abnormal 14.63 9.84 63 82889 41882 29827644
Tooth abscess 14.61 9.84 39 82913 5087 29864439
Conjunctivitis allergic 14.60 9.84 12 82940 522 29869004
Peritonitis 14.46 9.84 23 82929 21352 29848174
Ascites 14.42 9.84 51 82901 35870 29833656
Cutaneous vasculitis 14.39 9.84 28 82924 2963 29866563
Dermatosis 14.33 9.84 9 82943 255 29869271
Prostate cancer 14.20 9.84 28 82924 23929 29845597
Cardiac ventricular disorder 14.18 9.84 8 82944 185 29869341
Low birth weight baby 14.17 9.84 43 82909 6033 29863493
Hallucinations, mixed 14.15 9.84 25 82927 2458 29867068
Biliary sepsis 14.13 9.84 13 82939 659 29868867
Insomnia 14.12 9.84 178 82774 93158 29776368
Respiratory tract infection bacterial 14.09 9.84 12 82940 549 29868977
Colon cancer 14.05 9.84 3 82949 8369 29861157
Interleukin-2 receptor increased 14.03 9.84 7 82945 125 29869401
Anal abscess 13.88 9.84 38 82914 5031 29864495
Gingivitis 13.88 9.84 28 82924 3042 29866484
Balanoposthitis 13.87 9.84 16 82936 1060 29868466
Nocardiosis 13.85 9.84 30 82922 3425 29866101
Exostosis of external ear canal 13.82 9.84 4 82948 13 29869513
Osteomyelitis salmonella 13.81 9.84 5 82947 38 29869488
Mucous stools 13.77 9.84 15 82937 933 29868593
Dysentery 13.66 9.84 8 82944 199 29869327
Hepatitis C 13.61 9.84 10 82942 13195 29856331
Infusion site induration 13.59 9.84 8 82944 201 29869325
Leukocytosis 13.55 9.84 104 82848 21398 29848128
Respiratory arrest 13.52 9.84 39 82913 29219 29840307
Overdose 13.46 9.84 159 82793 84178 29785348
Device malfunction 13.43 9.84 3 82949 8108 29861418
Vesicoureteric reflux 13.41 9.84 7 82945 138 29869388
Tongue discolouration 13.41 9.84 16 82936 1099 29868427
Orbital myositis 13.40 9.84 6 82946 83 29869443
Pulmonary valve disease 13.34 9.84 6 82946 84 29869442
Spirometry abnormal 13.33 9.84 9 82943 289 29869237
Otitis media acute 13.27 9.84 10 82942 383 29869143
Superinfection bacterial 13.26 9.84 11 82941 485 29869041
Lymphadenopathy 13.25 9.84 114 82838 24262 29845264
Therapeutic response decreased 13.14 9.84 30 82922 24319 29845207
Injection site swelling 13.10 9.84 4 82948 8776 29860750
Ear swelling 13.09 9.84 10 82942 391 29869135
Endocarditis candida 13.03 9.84 6 82946 89 29869437
Blister 13.01 9.84 100 82852 20583 29848943
Blood urea increased 12.97 9.84 44 82908 31337 29838189
Dehydration 12.82 9.84 253 82699 123286 29746240
Erythema annulare 12.80 9.84 4 82948 18 29869508
Underdose 12.77 9.84 9 82943 12132 29857394
Localised oedema 12.67 9.84 27 82925 3049 29866477
Blood pressure fluctuation 12.65 9.84 18 82934 17485 29852041
Human herpesvirus 6 infection reactivation 12.62 9.84 4 82948 19 29869507
Accessory auricle 12.62 9.84 4 82948 19 29869507
Red blood cell sedimentation rate decreased 12.61 9.84 5 82947 50 29869476
Rebound acid hypersecretion 12.61 9.84 5 82947 50 29869476
Back pain 12.58 9.84 204 82748 102392 29767134
Abdominal wall haematoma 12.55 9.84 19 82933 1642 29867884
Haemolytic anaemia 12.54 9.84 58 82894 9952 29859574
Cataract 12.53 9.84 26 82926 21809 29847717
Toothache 12.52 9.84 40 82912 5771 29863755
Rotavirus infection 12.40 9.84 9 82943 325 29869201
Injection site erythema 12.39 9.84 12 82940 13822 29855704
Therapeutic product effect incomplete 12.31 9.84 50 82902 33784 29835742
Hyperthermia 12.28 9.84 58 82894 10041 29859485
Infectious mononucleosis 12.25 9.84 10 82942 431 29869095
Swelling of eyelid 12.24 9.84 9 82943 332 29869194
Alveolitis 12.08 9.84 19 82933 1698 29867828
Congenital heart valve disorder 12.03 9.84 5 82947 57 29869469
Schizophrenia 12.00 9.84 5 82947 9043 29860483
Periostosis 11.99 9.84 4 82948 23 29869503
Anal inflammation 11.98 9.84 9 82943 343 29869183
Cardiac failure 11.91 9.84 161 82791 83257 29786269
Body fat disorder 11.88 9.84 5 82947 59 29869467
Hospitalisation 11.82 9.84 73 82879 44246 29825280
Haematuria 11.78 9.84 182 82770 44652 29824874
Mobility decreased 11.76 9.84 35 82917 25964 29843562
Urinary retention 11.75 9.84 49 82903 32868 29836658
Drug interaction 11.74 9.84 670 82282 198898 29670628
Oral mucosal blistering 11.62 9.84 19 82933 1754 29867772
Sense of oppression 11.60 9.84 10 82942 465 29869061
Psoriatic arthropathy 11.60 9.84 16 82936 15745 29853781
Hordeolum 11.48 9.84 12 82940 712 29868814
Interstitial lung disease 11.42 9.84 109 82843 60088 29809438
Plasma cell myeloma 11.37 9.84 94 82858 53368 29816158
Ileal perforation 11.30 9.84 12 82940 725 29868801
Neoplasm malignant 11.28 9.84 20 82932 17794 29851732
Pyelocaliectasis 11.27 9.84 14 82938 1003 29868523
Anaphylactoid reaction 11.18 9.84 21 82931 2165 29867361
Musculoskeletal pain 11.08 9.84 46 82906 30894 29838632
Mast cell degranulation present 10.93 9.84 5 82947 73 29869453
Transplant rejection 10.82 9.84 6 82946 9200 29860326
Gastrointestinal ischaemia 10.82 9.84 7 82945 209 29869317
Gait disturbance 10.79 9.84 144 82808 74633 29794893
Ligament sprain 10.76 9.84 24 82928 2796 29866730
Blood immunoglobulin A increased 10.74 9.84 8 82944 301 29869225
Hypergammaglobulinaemia 10.67 9.84 7 82945 214 29869312
Dust allergy 10.63 9.84 9 82943 408 29869118
Ultrasound scan abnormal 10.63 9.84 5 82947 78 29869448
Anxiety 10.59 9.84 180 82772 89691 29779835
Noninfective sialoadenitis 10.54 9.84 3 82949 9 29869517
Pseudomembranous colitis 10.48 9.84 24 82928 2844 29866682
Gynaecomastia 10.47 9.84 5 82947 8346 29861180
Brain abscess 10.43 9.84 23 82929 2658 29866868
Acute myocardial infarction 10.41 9.84 95 82857 52844 29816682
Eczema 10.37 9.84 68 82884 13301 29856225
Blood pressure decreased 10.37 9.84 82 82870 46993 29822533
Contraindicated product administered 10.33 9.84 20 82932 17211 29852315
Vascular purpura 10.31 9.84 17 82935 1580 29867946
Weight decreased 10.27 9.84 329 82623 150592 29718934
Arthralgia 10.23 9.84 292 82660 135499 29734027
Multiple sclerosis relapse 10.22 9.84 9 82943 10853 29858673
Resorption bone increased 10.19 9.84 5 82947 86 29869440
Epstein-Barr virus antibody positive 10.19 9.84 8 82944 326 29869200
Pneumococcal sepsis 10.18 9.84 11 82941 678 29868848
Infusion site swelling 10.17 9.84 17 82935 1599 29867927
Stomatitis 10.16 9.84 61 82891 37218 29832308
C-reactive protein increased 10.13 9.84 173 82779 43300 29826226
Penile swelling 10.08 9.84 12 82940 822 29868704
Candida infection 10.07 9.84 75 82877 15287 29854239
Coronavirus test positive 10.06 9.84 8 82944 332 29869194
Skin graft failure 10.04 9.84 6 82946 155 29869371
Peritonitis bacterial 10.04 9.84 10 82942 11368 29858158
Glycosylated haemoglobin increased 10.03 9.84 7 82945 9484 29860042
Dermatitis exfoliative 9.94 9.84 44 82908 7412 29862114
Diarrhoea haemorrhagic 9.92 9.84 37 82915 5768 29863758
Hypersomnia 9.92 9.84 10 82942 11306 29858220
Small intestinal obstruction 9.92 9.84 14 82938 13645 29855881
Venoocclusive liver disease 9.89 9.84 3 82949 6610 29862916
Precancerous condition 9.88 9.84 3 82949 12 29869514
Genital lesion 9.86 9.84 7 82945 244 29869282
Dementia 9.84 9.84 12 82940 12449 29857077

Pharmacologic Action:

SourceCodeDescription
ATC J01CA04 ANTIINFECTIVES FOR SYSTEMIC USE
ANTIBACTERIALS FOR SYSTEMIC USE
BETA-LACTAM ANTIBACTERIALS, PENICILLINS
Penicillins with extended spectrum
ATC A02BD01 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 A02BD03 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 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 A02BD10 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 A02BD13 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 A02BD15 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 J01CR02 ANTIINFECTIVES FOR SYSTEMIC USE
ANTIBACTERIALS FOR SYSTEMIC USE
BETA-LACTAM ANTIBACTERIALS, PENICILLINS
Combinations of penicillins, incl. beta-lactamase inhibitors
FDA CS M0016152 Penicillins
FDA EPC N0000175497 Penicillin-class Antibacterial
CHEBI has role CHEBI:36047 antibacterial drugs
MeSH PA D000900 Anti-Bacterial Agents
MeSH PA D000890 Anti-Infective Agents

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Acute otitis media indication 3110003
Staphylococcal tonsillitis indication 11461005
Infection of skin AND/OR subcutaneous tissue indication 19824006
Pneumonia due to Streptococcus indication 34020007
Streptococcal tonsillitis indication 41582007
Lower respiratory tract infection indication 50417007
Bacterial pneumonia indication 53084003 DOID:874
Klebsiella cystitis indication 60867007
Pneumonia due to Klebsiella pneumoniae indication 64479007
Urinary tract infectious disease indication 68566005
Haemophilus influenzae pneumonia indication 70036007
Infection due to Escherichia coli indication 71057007
Rhinoscleroma indication 72409005 DOID:11336
Acute bacterial sinusitis indication 75498004
Staphylococcal pharyngitis indication 82228008
Pneumococcal pneumonia indication 233607000
Escherichia coli urinary tract infection indication 301011002
Streptococcus pyogenes infection indication 302809008
Bacterial urinary infection indication 312124009
Infective otitis media indication 312218008
Pharyngitis indication 405737000 DOID:2275
Infection due to Staphylococcus aureus indication 406602003
Acute exacerbation of chronic bronchitis indication 425748003
Pneumonia due to Staphylococcus aureus indication 441658007
Helicobacter pylori-associated gastritis indication 708164002
Skin and Skin Structure Streptococcus Infection indication
E. Coli Genitourinary Tract Infection indication
Moraxella Catarrhalis Acute Otitis Media indication
Duodenal Ulcer due to H. Pylori indication
Haemophilus Influenzae Chronic Bronchitis indication
Moraxella Catarrhalis Pneumonia indication
Tonsillitis due to Haemophilus Influenzae indication
Genitourinary Tract Infections indication
Haemophilus Influenzae Pharyngitis indication
Genitourinary Tract Infection due to Proteus indication
Haemophilus Influenzae Acute Otitis Media indication
Pneumococcal Acute Otitis Media indication
Haemophilus Parainfluenzae Pneumonia indication
Streptococcus Pneumoniae Chronic Bronchitis indication
Enterococcus Genitourinary Tract Infection indication
Typhoid fever off-label use 4834000 DOID:13258
Pyrexia of unknown origin off-label use 7520000
Lyme disease off-label use 23502006 DOID:11729
Chronic purulent otitis media off-label use 38394007 DOID:14247
Cholangitis off-label use 82403002 DOID:9446
Human bite - wound off-label use 262555007
Chancroid off-label use 266143009 DOID:13778
Diverticulitis of gastrointestinal tract off-label use 271366000
Dog bite - wound off-label use 283734005
Cat bite - wound off-label use 283782004
Prevention of Bacterial Endocarditis off-label use
Diabetic Foot Infection off-label use
Prevention of Neonatal Group B Streptococcal Infection 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

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 2.79 acidic
pKa2 9.72 acidic
pKa3 7.63 Basic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
5-hydroxytryptamine receptor 2B GPCR IC50 5.96 WOMBAT-PK
5-hydroxytryptamine receptor 2A GPCR IC50 6.22 WOMBAT-PK
5-hydroxytryptamine receptor 2C GPCR IC50 5.80 WOMBAT-PK
Bacterial penicillin-binding protein Enzyme INHIBITOR CHEMBL CHEMBL
Penicillin-binding protein 1A Enzyme WOMBAT-PK

External reference:

IDSource
9EM05410Q9 UNII
4017605 VUID
N0000145985 NUI
D00229 KEGG_DRUG
34642-77-8 SECONDARY_CAS_RN
C0002645 UMLSCUI
CHEBI:2676 CHEBI
AXL PDB_CHEM_ID
CHEMBL1082 ChEMBL_ID
CHEMBL2105950 ChEMBL_ID
DB01060 DRUGBANK_ID
D000658 MESH_DESCRIPTOR_UI
33613 PUBCHEM_CID
3230 INN_ID
10895 IUPHAR_LIGAND_ID
1297882 RXNORM
11786 MMSL
3600 MMSL
4187 MMSL
d00088 MMSL
002707 NDDF
003675 NDDF
003718 NDDF
27658006 SNOMEDCT_US
372687004 SNOMEDCT_US
427483001 SNOMEDCT_US
785686003 SNOMEDCT_US
96068000 SNOMEDCT_US
4017604 VANDF
4017605 VANDF

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Amoxicillin and Clavulanate Potassium HUMAN PRESCRIPTION DRUG LABEL 3 0781-1943 TABLET, MULTILAYER, EXTENDED RELEASE 437.50 mg ORAL ANDA 26 sections
Amoxicillin and Clavulanate Potassium Extended Release HUMAN PRESCRIPTION DRUG LABEL 3 43598-220 TABLET, FILM COATED, EXTENDED RELEASE 437.50 mg ORAL NDA 27 sections