amoxicillin ๐Ÿถ Veterinary Use | 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 ยตM/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 851.72 9.77 1508 82782 249502 50271332
Rash maculo-papular 546.80 9.77 410 83880 26231 50494603
Pruritus 415.30 9.77 1222 83068 282346 50238488
Urticaria 411.85 9.77 758 83532 128803 50392031
Angioedema 408.04 9.77 402 83888 37274 50483560
Drug reaction with eosinophilia and systemic symptoms 392.06 9.77 347 83943 28077 50492757
Erythema 326.74 9.77 740 83550 145674 50375160
Anaphylactic shock 302.01 9.77 258 84032 19897 50500937
Cross sensitivity reaction 300.99 9.77 116 84174 1853 50518981
Lip swelling 253.11 9.77 256 84034 24480 50496354
Acute generalised exanthematous pustulosis 249.33 9.77 166 84124 8772 50512062
Abortion spontaneous 247.46 9.77 326 83964 41446 50479388
Type IV hypersensitivity reaction 229.17 9.77 102 84188 2380 50518454
Drug ineffective 223.13 9.77 667 83623 818666 49702168
Toxic skin eruption 212.79 9.77 165 84125 11086 50509748
Lip oedema 210.59 9.77 104 84186 3089 50517745
Rash 204.79 9.77 1336 82954 436135 50084699
Anaphylactic reaction 190.31 9.77 331 83959 53724 50467110
Face oedema 181.35 9.77 184 84106 17655 50503179
Pemphigus 180.73 9.77 4 84286 120162 50400672
Synovitis 166.28 9.77 10 84280 123855 50396979
Systemic lupus erythematosus 151.33 9.77 26 84264 140596 50380238
Type I hypersensitivity 149.36 9.77 75 84215 2310 50518524
Swelling face 146.19 9.77 291 83999 52304 50468530
Swollen tongue 144.73 9.77 207 84083 28423 50492411
Hepatocellular injury 140.66 9.77 194 84096 25753 50495081
Arthropathy 130.28 9.77 50 84240 157856 50362978
Stevens-Johnson syndrome 129.14 9.77 170 84120 21582 50499252
White blood cell count abnormal 128.03 9.77 91 84199 5349 50515485
Macular degeneration 127.63 9.77 138 84152 14250 50506584
Crystalluria 125.57 9.77 40 84250 349 50520485
Tongue oedema 123.53 9.77 78 84212 3761 50517073
Hand deformity 118.34 9.77 14 84276 100185 50420649
Acute kidney injury 117.12 9.77 714 83576 227344 50293490
Rash pruritic 116.83 9.77 251 84039 47595 50473239
Cholecystitis chronic 113.68 9.77 108 84182 9561 50511273
Alopecia 112.47 9.77 146 84144 244901 50275933
Glossodynia 110.68 9.77 28 84262 115541 50405293
Infusion related reaction 106.91 9.77 76 84214 169481 50351353
Erythema multiforme 106.24 9.77 101 84189 8949 50511885
Death 104.58 9.77 243 84047 325136 50195698
Wound closure 102.56 9.77 26 84264 86 50520748
Completed suicide 100.38 9.77 47 84243 131842 50388992
Eosinophilia 97.42 9.77 137 84153 18515 50502319
Therapeutic product effect decreased 96.78 9.77 53 84237 135997 50384837
Pericarditis 95.42 9.77 10 84280 78679 50442155
Rash erythematous 94.63 9.77 191 84099 34661 50486173
Enterocolitis haemorrhagic 91.87 9.77 45 84245 1312 50519522
Fatigue 89.33 9.77 753 83537 706848 49813986
Osteotomy 86.99 9.77 26 84264 179 50520655
Jaundice 86.73 9.77 157 84133 26272 50494562
Rash macular 85.36 9.77 131 84159 19146 50501688
Wound 84.76 9.77 35 84255 105759 50415075
Off label use 84.73 9.77 455 83835 473971 50046863
Tubulointerstitial nephritis 81.34 9.77 113 84177 15098 50505736
Treatment failure 81.23 9.77 66 84224 137571 50383263
Paraesthesia oral 81.17 9.77 101 84189 12120 50508714
Fall 76.61 9.77 293 83997 334639 50186195
Cholestasis 74.74 9.77 144 84146 25257 50495577
Arthralgia 74.33 9.77 428 83862 438274 50082560
Product use issue 71.71 9.77 86 84204 149389 50371445
Abdominal discomfort 71.16 9.77 177 84113 231464 50289370
Toxic epidermal necrolysis 70.54 9.77 126 84164 20866 50499968
Contraindicated product administered 70.09 9.77 87 84203 148871 50371963
Maternal exposure during pregnancy 67.74 9.77 477 83813 159301 50361533
Meningitis aseptic 65.97 9.77 55 84235 4097 50516737
Discomfort 65.16 9.77 51 84239 108329 50412505
Duodenal ulcer perforation 63.31 9.77 3 84287 45608 50475226
Rash morbilliform 63.29 9.77 46 84244 2800 50518034
Hepatitis cholestatic 60.17 9.77 62 84228 6055 50514779
Drug intolerance 60.08 9.77 177 84113 218927 50301907
Joint swelling 55.11 9.77 216 84074 245070 50275764
Eyelid oedema 54.66 9.77 73 84217 9393 50511441
Dermatitis allergic 54.30 9.77 85 84205 12635 50508199
Emotional distress 54.16 9.77 136 84154 28527 50492307
Hallucinations, mixed 52.41 9.77 48 84242 4055 50516779
Injury 52.40 9.77 190 84100 48735 50472099
Hepatic enzyme increased 51.31 9.77 94 84196 137286 50383548
Throat tightness 50.44 9.77 109 84181 20738 50500096
Injection site pain 49.99 9.77 67 84223 110957 50409877
Clostridium difficile infection 49.43 9.77 122 84168 25317 50495517
Swelling 48.29 9.77 172 84118 200700 50320134
Therapeutic product effect incomplete 47.89 9.77 49 84241 91466 50429368
Periorbital oedema 47.86 9.77 50 84240 4962 50515872
Laryngeal oedema 47.52 9.77 50 84240 5003 50515831
Basilar artery occlusion 46.89 9.77 14 84276 96 50520738
Tooth demineralisation 46.01 9.77 9 84281 3 50520831
Drug eruption 45.64 9.77 113 84177 23493 50497341
Skin candida 45.33 9.77 28 84262 1298 50519536
Vascular purpura 45.00 9.77 27 84263 1187 50519647
Dermatitis exfoliative generalised 44.74 9.77 39 84251 3087 50517747
Muscle injury 44.26 9.77 5 84285 37106 50483728
Injection site erythema 44.10 9.77 36 84254 74900 50445934
Weight increased 42.07 9.77 183 84107 201708 50319126
Diarrhoea 41.51 9.77 1277 83013 587199 49933635
Loss of personal independence in daily activities 40.80 9.77 34 84256 70016 50450818
Folliculitis 40.55 9.77 8 84282 39217 50481617
Vomiting 39.75 9.77 1026 83264 459732 50061102
Purpura 39.24 9.77 64 84226 9847 50510987
Pseudomembranous colitis 38.37 9.77 34 84256 2751 50518083
Impaired healing 38.08 9.77 36 84254 69750 50451084
Documented hypersensitivity to administered product 37.71 9.77 18 84272 495 50520339
Malaise 37.53 9.77 775 83515 334757 50186077
Bronchospasm 36.32 9.77 78 84212 14776 50506058
Agranulocytosis 35.72 9.77 97 84193 21324 50499510
Premature baby 35.69 9.77 88 84202 18249 50502585
Febrile neutropenia 33.70 9.77 70 84220 97597 50423237
Knee arthroplasty 33.69 9.77 9 84281 35837 50484997
Hyperleukocytosis 33.26 9.77 16 84274 448 50520386
Mobility decreased 33.26 9.77 51 84239 79897 50440937
Condition aggravated 32.52 9.77 327 83963 296731 50224103
Drug abuse 32.50 9.77 31 84259 59815 50461019
Flank pain 32.22 9.77 69 84221 13046 50507788
Dental operation 32.18 9.77 21 84269 1072 50519762
Tongue discolouration 32.16 9.77 31 84259 2793 50518041
Thermal burn 32.13 9.77 40 84250 4801 50516033
Hepatic ischaemia 32.04 9.77 17 84273 588 50520246
Peritonsillar abscess 31.91 9.77 16 84274 491 50520343
Chronic sinusitis 31.88 9.77 45 84245 6100 50514734
Chronic kidney disease 31.79 9.77 141 84149 39630 50481204
Eczema 31.28 9.77 96 84194 22606 50498228
Salpingo-oophorectomy unilateral 30.93 9.77 16 84274 525 50520309
Foetal exposure during pregnancy 30.78 9.77 108 84182 27251 50493583
Drug interaction 30.73 9.77 485 83805 199136 50321698
Palatal oedema 30.70 9.77 15 84275 435 50520399
Somatic delusion 30.25 9.77 16 84274 550 50520284
Moraxella test positive 29.80 9.77 7 84283 15 50520819
Clostridium difficile colitis 29.24 9.77 80 84210 17662 50503172
Wheezing 29.09 9.77 190 84100 61857 50458977
Toxicity to various agents 28.97 9.77 221 84069 212278 50308556
Abdominal pain 28.16 9.77 551 83739 235677 50285157
Gallbladder disorder 28.10 9.77 76 84214 16666 50504168
Device expulsion 27.54 9.77 7 84283 28815 50492019
Intentional product use issue 27.50 9.77 54 84236 76864 50443970
Chromaturia 27.32 9.77 69 84221 14521 50506313
Injection site swelling 27.26 9.77 18 84272 41755 50479079
Dermatitis exfoliative 27.19 9.77 38 84252 5104 50515730
Acute hepatic failure 27.15 9.77 72 84218 15605 50505229
Stomatitis 26.93 9.77 83 84207 101261 50419573
Eye swelling 26.66 9.77 84 84206 20060 50500774
Sinusitis fungal 26.55 9.77 20 84270 1286 50519548
Irritable bowel syndrome 26.39 9.77 28 84262 51413 50469421
Breast cancer 25.99 9.77 20 84270 42870 50477964
Localised oedema 25.78 9.77 36 84254 4831 50516003
Candida infection 25.73 9.77 92 84198 23431 50497403
Muscle relaxant therapy 25.59 9.77 10 84280 166 50520668
Helicobacter infection 25.55 9.77 27 84263 49675 50471159
Oral discomfort 25.50 9.77 47 84243 7970 50512864
Normal tension glaucoma 25.48 9.77 7 84283 34 50520800
Rheumatoid arthritis 25.15 9.77 216 84074 202334 50318500
Hepatic cytolysis 25.15 9.77 47 84243 8056 50512778
Deafness 25.11 9.77 70 84220 15621 50505213
Excessive eye blinking 25.01 9.77 17 84273 929 50519905
Staphylococcal scalded skin syndrome 24.90 9.77 9 84281 119 50520715
Tooth infection 24.63 9.77 65 84225 14047 50506787
Ill-defined disorder 24.57 9.77 33 84257 54621 50466213
Influenza B virus test positive 24.54 9.77 11 84279 261 50520573
Tinnitus 24.22 9.77 102 84188 28030 50492804
Biliary sepsis 24.22 9.77 16 84274 834 50520000
Allergy to chemicals 24.02 9.77 19 84271 1313 50519521
Dermatitis bullous 24.02 9.77 43 84247 7130 50513704
Hip arthroplasty 22.89 9.77 11 84279 30418 50490416
Skin test positive 22.82 9.77 14 84276 641 50520193
Drug-induced liver injury 22.75 9.77 100 84190 27995 50492839
Malignant neoplasm progression 22.52 9.77 50 84240 68074 50452760
Crystal nephropathy 22.40 9.77 15 84275 800 50520034
Arthritis 22.35 9.77 72 84218 86649 50434185
Pain in extremity 22.33 9.77 320 83970 272545 50248289
Injection site pruritus 21.86 9.77 21 84269 40390 50480444
Lymphadenopathy 21.86 9.77 112 84178 33387 50487447
Hepatitis 21.82 9.77 107 84183 31346 50489488
Therapeutic response decreased 21.76 9.77 28 84262 47203 50473631
Tongue coated 21.53 9.77 17 84273 1172 50519662
Hepatorenal syndrome 21.50 9.77 20 84270 1723 50519111
Psychotic symptom 21.24 9.77 17 84273 1195 50519639
Foetal non-stress test abnormal 21.22 9.77 6 84284 33 50520801
Pneumonia aspiration 20.72 9.77 13 84277 30991 50489843
Hyperaemia 20.56 9.77 21 84269 2029 50518805
Pharyngeal paraesthesia 20.37 9.77 18 84272 1451 50519383
Pharyngeal oedema 20.35 9.77 58 84232 13107 50507727
Visual snow syndrome 20.35 9.77 5 84285 14 50520820
Sputum increased 20.34 9.77 20 84270 1847 50518987
Interstitial lung disease 20.18 9.77 36 84254 53140 50467694
Foetal heart rate decreased 20.14 9.77 8 84282 139 50520695
Prothrombin time ratio decreased 20.11 9.77 11 84279 405 50520429
Adverse event 20.10 9.77 26 84264 43737 50477097
Anhedonia 19.92 9.77 47 84243 9477 50511357
Lip erosion 19.89 9.77 14 84276 810 50520024
Choluria 19.73 9.77 8 84282 147 50520687
Oedema 19.71 9.77 191 84099 69990 50450844
Coma 19.42 9.77 41 84249 56838 50463996
Gastrointestinal disorder 19.42 9.77 86 84204 94370 50426464
Respiratory failure 19.36 9.77 82 84208 91099 50429735
Osteonecrosis of jaw 19.34 9.77 106 84184 32420 50488414
Mouth swelling 19.32 9.77 28 84262 3888 50516946
Blood pressure increased 19.30 9.77 136 84154 132996 50387838
Multiple sclerosis relapse 19.25 9.77 26 84264 42938 50477896
Blood glucose increased 19.24 9.77 58 84232 71266 50449568
Pulmonary artery stenosis congenital 19.22 9.77 9 84281 237 50520597
Peripheral swelling 19.21 9.77 235 84055 205701 50315133
Nasopharyngitis 18.82 9.77 218 84072 192709 50328125
Eosinophils urine present 18.79 9.77 5 84285 21 50520813
Neutropenic sepsis 18.72 9.77 59 84231 14088 50506746
Symmetrical drug-related intertriginous and flexural exanthema 18.69 9.77 10 84280 352 50520482
Psoriatic arthropathy 18.61 9.77 31 84259 47001 50473833
Labile blood pressure 18.49 9.77 18 84272 1642 50519192
Biliary dyskinesia 18.43 9.77 22 84268 2528 50518306
International normalised ratio increased 18.34 9.77 129 84161 43023 50477811
Laryngeal discomfort 17.99 9.77 9 84281 275 50520559
Exposure during pregnancy 17.84 9.77 292 83998 120723 50400111
Mouth ulceration 17.80 9.77 93 84197 27931 50492903
Myocardial infarction 17.73 9.77 82 84208 88945 50431889
Fluid retention 17.72 9.77 36 84254 50613 50470221
Sedation 17.64 9.77 15 84275 30595 50490239
Fibromyalgia 17.47 9.77 30 84260 44948 50475886
Pharyngeal swelling 17.42 9.77 29 84261 4537 50516297
Septic shock 17.28 9.77 44 84246 57131 50463703
Eosinophilic pneumonia acute 17.24 9.77 9 84281 301 50520533
Medication error 17.19 9.77 111 84179 35993 50484841
Biliary colic 17.11 9.77 24 84266 3235 50517599
Hepatic failure 17.09 9.77 102 84188 32181 50488653
SJS-TEN overlap 17.00 9.77 8 84282 213 50520621
Incorrect route of product administration 16.96 9.77 5 84285 18661 50502173
Skin reaction 16.95 9.77 50 84240 11518 50509316
Norovirus test positive 16.90 9.77 7 84283 136 50520698
Tryptase increased 16.83 9.77 8 84282 218 50520616
Neutrophilia 16.82 9.77 25 84265 3550 50517284
Odynophagia 16.78 9.77 35 84255 6497 50514337
Swelling of eyelid 16.77 9.77 18 84272 1842 50518992
Genital erosion 16.54 9.77 7 84283 144 50520690
Dyspnoea 16.51 9.77 1090 83200 546518 49974316
Diastasis recti abdominis 16.42 9.77 5 84285 37 50520797
Hepatitis acute 16.34 9.77 39 84251 7922 50512912
Behaviour disorder 16.33 9.77 20 84270 2360 50518474
Atrial septal defect 16.32 9.77 34 84256 6307 50514527
Blood cholesterol increased 16.29 9.77 43 84247 55172 50465662
Red blood cell sedimentation rate increased 16.25 9.77 15 84275 29401 50491433
Joint injury 16.20 9.77 8 84282 21781 50499053
Congenital melanocytic naevus 16.20 9.77 3 84287 0 50520834
Diabetes mellitus 16.19 9.77 36 84254 48997 50471837
Deep vein thrombosis 16.14 9.77 190 84100 73114 50447720
Bipolar I disorder 16.05 9.77 16 84274 1502 50519332
Pharyngotonsillitis 15.98 9.77 7 84283 157 50520677
Glomerulonephritis acute 15.97 9.77 5 84285 41 50520793
Lymphocytosis 15.92 9.77 19 84271 2183 50518651
Dysphonia 15.80 9.77 115 84175 38777 50482057
Underdose 15.76 9.77 7 84283 20271 50500563
Serotonin syndrome 15.65 9.77 11 84279 24702 50496132
Haematuria 15.58 9.77 84 84206 25529 50495305
Nail dystrophy 15.56 9.77 12 84278 799 50520035
Polymenorrhagia 15.56 9.77 5 84285 45 50520789
Tubulointerstitial nephritis and uveitis syndrome 15.50 9.77 7 84283 169 50520665
Cardiac failure congestive 15.49 9.77 80 84210 84302 50436532
Femoral artery embolism 15.27 9.77 5 84285 48 50520786
Rash papular 15.27 9.77 51 84239 12553 50508281
Nasal polyps 15.21 9.77 20 84270 2534 50518300
Fixed eruption 15.20 9.77 12 84278 827 50520007
Skin exfoliation 15.19 9.77 102 84188 33510 50487324
PRIDE syndrome 15.19 9.77 4 84286 16 50520818
Cardiac failure 15.17 9.77 70 84220 75970 50444864
Budd-Chiari syndrome 15.09 9.77 5 84285 50 50520784
General physical health deterioration 15.06 9.77 158 84132 142276 50378558
Accidental exposure to product 14.95 9.77 10 84280 23047 50497787
Tangentiality 14.81 9.77 4 84286 18 50520816
Sebaceous gland infection 14.76 9.77 6 84284 111 50520723
Tooth discolouration 14.71 9.77 12 84278 867 50519967
Pseudomyopia 14.66 9.77 5 84285 55 50520779
Mixed liver injury 14.64 9.77 23 84267 3428 50517406
Respiratory symptom 14.53 9.77 19 84271 2395 50518439
Forced vital capacity abnormal 14.46 9.77 4 84286 20 50520814
Pain 14.46 9.77 803 83487 578100 49942734
Hypoaesthesia oral 14.44 9.77 45 84245 10683 50510151
Gallbladder cholesterolosis 14.42 9.77 11 84279 721 50520113
Caffeine allergy 14.30 9.77 4 84286 21 50520813
Fear-related avoidance of activities 14.28 9.77 6 84284 121 50520713
Cell death 14.22 9.77 18 84272 2197 50518637
Atrophy 14.20 9.77 15 84275 1508 50519326
Injection site haemorrhage 14.19 9.77 9 84281 21337 50499497
Contusion 14.19 9.77 119 84171 112064 50408770
Tongue pruritus 14.16 9.77 9 84281 439 50520395
Cholestasis of pregnancy 14.00 9.77 13 84277 1118 50519716
Injection site warmth 13.98 9.77 3 84287 13863 50506971
Mania 13.97 9.77 45 84245 10871 50509963
Mucosal discolouration 13.92 9.77 9 84281 452 50520382
Fulminant type 1 diabetes mellitus 13.91 9.77 8 84282 325 50520509
Foetal hypokinesia 13.89 9.77 9 84281 454 50520380
Coagulopathy 13.87 9.77 63 84227 17881 50502953
Cheilitis 13.87 9.77 23 84267 3587 50517247
Monoclonal gammopathy 13.84 9.77 10 84280 603 50520231
Pharyngitis streptococcal 13.80 9.77 39 84251 8769 50512065
Mucosal inflammation 13.70 9.77 114 84176 40028 50480806
Reaction to excipient 13.70 9.77 13 84277 1149 50519685
Actinomycosis 13.69 9.77 12 84278 957 50519877
Sweat discolouration 13.66 9.77 3 84287 4 50520830
Conjunctivitis 13.48 9.77 58 84232 16087 50504747
Haemolytic anaemia 13.46 9.77 40 84250 9252 50511582
Gamma-glutamyltransferase increased 13.45 9.77 90 84200 29533 50491301
Lip pain 13.33 9.77 15 84275 1619 50519215
Cholecystitis 13.29 9.77 52 84238 13819 50507015
Injection site reaction 13.27 9.77 41 84249 49991 50470843
Delusion of grandeur 13.21 9.77 6 84284 147 50520687
Lymphadenitis 13.09 9.77 19 84271 2641 50518193
Skin swelling 13.05 9.77 17 84273 2135 50518699
Human herpesvirus 6 encephalitis 12.99 9.77 6 84284 153 50520681
Full blood count abnormal 12.83 9.77 12 84278 23376 50497458
Toothache 12.83 9.77 59 84231 16835 50503999
Therapy non-responder 12.70 9.77 43 84247 50979 50469855
Pharyngeal abscess 12.67 9.77 7 84283 263 50520571
Lice infestation 12.60 9.77 3 84287 7 50520827
Allergy test negative 12.60 9.77 3 84287 7 50520827
Palatal swelling 12.58 9.77 5 84285 87 50520747
Erythema nodosum 12.56 9.77 23 84267 3880 50516954
Rash pustular 12.50 9.77 31 84259 6450 50514384
Facial paralysis 12.46 9.77 48 84242 12667 50508167
Klebsiella infection 12.42 9.77 33 84257 7161 50513673
Embolism venous 12.38 9.77 18 84272 2507 50518327
Delayed delivery 12.35 9.77 4 84286 37 50520797
Hypertension 12.34 9.77 263 84027 210940 50309894
Platelet count decreased 12.22 9.77 108 84182 100618 50420216
Lymphocyte morphology abnormal 12.19 9.77 8 84282 412 50520422
Macule 12.16 9.77 14 84276 1548 50519286
Congenital tricuspid valve incompetence 12.08 9.77 5 84285 97 50520737
Genital prolapse 12.07 9.77 4 84286 40 50520794
Pneumopericardium 11.98 9.77 4 84286 41 50520793
Injection site rash 11.94 9.77 6 84284 16171 50504663
Vitiligo 11.90 9.77 12 84278 1142 50519692
Localised infection 11.85 9.77 15 84275 25470 50495364
Ear infection 11.85 9.77 79 84211 25891 50494943
Delirium 11.84 9.77 29 84261 38163 50482671
Cognitive disorder 11.81 9.77 36 84254 44087 50476747
Wrong technique in product usage process 11.73 9.77 50 84240 55460 50465374
Periorbital swelling 11.65 9.77 15 84275 1862 50518972
Right ventricular failure 11.57 9.77 6 84284 15887 50504947
Fibrous histiocytoma 11.55 9.77 8 84282 451 50520383
Target skin lesion 11.54 9.77 5 84285 109 50520725
Anxiety 11.53 9.77 382 83908 177224 50343610
Oropharyngeal discomfort 11.50 9.77 22 84268 3836 50516998
Eosinophilic pneumonia 11.48 9.77 15 84275 1889 50518945
Hypotonia neonatal 11.46 9.77 11 84279 986 50519848
Infectious mononucleosis 11.43 9.77 14 84276 1652 50519182
Premature delivery 11.41 9.77 73 84217 23590 50497244
Non-alcoholic steatohepatitis 11.41 9.77 13 84277 1422 50519412
Abnormal faeces 11.39 9.77 23 84267 4173 50516661
Injection site bruising 11.34 9.77 28 84262 36740 50484094
Respiratory depression 11.31 9.77 3 84287 12007 50508827
Hypovolaemic shock 11.28 9.77 26 84264 5162 50515672
Tooth disorder 11.23 9.77 74 84216 24154 50496680
Crepitations 11.22 9.77 29 84261 6190 50514644
Tonsillitis streptococcal 11.20 9.77 4 84286 51 50520783
Foetal distress syndrome 11.14 9.77 12 84278 1233 50519601
Hypersensitivity 11.10 9.77 451 83839 214710 50306124
Actinic keratosis 11.10 9.77 16 84274 2211 50518623
Hepatic necrosis 11.08 9.77 26 84264 5222 50515612
Bone disorder 11.07 9.77 61 84229 18691 50502143
Linear IgA disease 11.07 9.77 12 84278 1242 50519592
Dysphagia 11.03 9.77 186 84104 77332 50443502
Incision site haemorrhage 11.00 9.77 8 84282 487 50520347
Cholelithiasis 10.98 9.77 104 84186 37869 50482965
Pneumonia mycoplasmal 10.98 9.77 10 84280 839 50519995
Anion gap increased 10.95 9.77 13 84277 1486 50519348
Hepatitis toxic 10.90 9.77 18 84272 2798 50518036
Mental status changes 10.89 9.77 28 84262 36244 50484590
Spinal subdural haematoma 10.88 9.77 5 84285 126 50520708
Erythromelalgia 10.88 9.77 5 84285 126 50520708
Carcinoid crisis 10.87 9.77 6 84284 225 50520609
Bone erosion 10.86 9.77 3 84287 11684 50509150
Death neonatal 10.84 9.77 6 84284 226 50520608
Tonsillar hypertrophy 10.81 9.77 10 84280 856 50519978
Herpes simplex test positive 10.81 9.77 5 84285 128 50520706
Pharyngeal erythema 10.72 9.77 13 84277 1519 50519315
Caesarean section 10.70 9.77 53 84237 15586 50505248
Hepatosplenomegaly 10.64 9.77 16 84274 2296 50518538
Injury corneal 10.61 9.77 4 84286 60 50520774
Sacroiliitis 10.59 9.77 17 84273 2580 50518254
Anaemia 10.57 9.77 330 83960 252126 50268708
Maternal drugs affecting foetus 10.56 9.77 25 84265 5052 50515782
Product complaint 10.55 9.77 3 84287 11463 50509371
Lip ulceration 10.54 9.77 14 84276 1791 50519043
Tongue haemorrhage 10.54 9.77 7 84283 368 50520466
Pleural effusion 10.48 9.77 86 84204 81368 50439466
Enanthema 10.47 9.77 7 84283 372 50520462
Lip discolouration 10.45 9.77 8 84282 527 50520307
Jaundice cholestatic 10.45 9.77 25 84265 5086 50515748
Helicobacter test positive 10.37 9.77 7 84283 378 50520456
Blood test abnormal 10.34 9.77 3 84287 11316 50509518
Intentional self-injury 10.34 9.77 14 84276 23098 50497736
Depressed level of consciousness 10.26 9.77 48 84242 51905 50468929
Prescribed underdose 10.23 9.77 7 84283 15942 50504892
Feeling hot 10.18 9.77 105 84185 39097 50481737
Inappropriate schedule of product administration 10.10 9.77 74 84216 71757 50449077
Palpitations 10.10 9.77 217 84073 94289 50426545
Rheumatic fever 10.05 9.77 8 84282 16859 50503975
Claudication of jaw muscles 10.04 9.77 4 84286 70 50520764
Transaminases increased 10.03 9.77 80 84210 27744 50493090
Fracture 10.01 9.77 8 84282 16825 50504009
Sebaceous gland disorder 9.99 9.77 3 84287 21 50520813
Multiple lentigines syndrome 9.99 9.77 5 84285 153 50520681
Overdose 9.98 9.77 112 84178 99615 50421219
Neoplasm progression 9.96 9.77 21 84269 29136 50491698
Metastases to lung 9.92 9.77 3 84287 11017 50509817
Pyrexia 9.89 9.77 748 83542 379455 50141379
Hypersensitivity myocarditis 9.87 9.77 3 84287 22 50520812
Nephritis allergic 9.87 9.77 5 84285 157 50520677
Product storage error 9.85 9.77 4 84286 12220 50508614
Female genital tract fistula 9.84 9.77 20 84270 3646 50517188
Labelled drug-drug interaction medication error 9.82 9.77 39 84251 10438 50510396

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 437.84 10.40 382 53724 27610 29492811
Pruritus 406.55 10.40 749 53357 116100 29404321
Urticaria 398.15 10.40 495 53611 54165 29466256
Anaphylactic shock 382.49 10.40 261 53845 13075 29507346
Rash maculo-papular 249.52 10.40 263 53843 24026 29496395
Rash 247.06 10.40 835 53271 188984 29331437
Erythema 221.26 10.40 451 53655 75155 29445266
Anaphylactic reaction 217.20 10.40 260 53846 27313 29493108
Angioedema 216.22 10.40 279 53827 31636 29488785
Meningitis aseptic 202.44 10.40 95 54011 2281 29518140
Acute generalised exanthematous pustulosis 198.41 10.40 125 53981 5458 29514963
Lip oedema 196.71 10.40 91 54015 2113 29518308
Drug hypersensitivity 175.68 10.40 387 53719 68019 29452402
Death 165.06 10.40 232 53874 341852 29178569
Eosinophilia 163.18 10.40 202 53904 21959 29498462
Cross sensitivity reaction 150.96 10.40 64 54042 1198 29519223
Face oedema 128.75 10.40 124 53982 10159 29510262
Acute kidney injury 122.76 10.40 867 53239 264400 29256021
Hepatocellular injury 119.90 10.40 170 53936 21073 29499348
Crystalluria 119.35 10.40 40 54066 375 29520046
Cholestasis 118.27 10.40 178 53928 23284 29497137
Lip swelling 116.18 10.40 128 53978 12282 29508139
Stevens-Johnson syndrome 105.11 10.40 140 53966 16357 29504064
Type I hypersensitivity 104.28 10.40 47 54059 1025 29519396
Toxic epidermal necrolysis 100.56 10.40 144 53962 18009 29502412
Wound closure 99.77 10.40 24 54082 52 29520369
Osteotomy 98.55 10.40 24 54082 56 29520365
Hypersensitivity 85.20 10.40 251 53855 52652 29467769
Kounis syndrome 83.21 10.40 48 54058 1781 29518640
Rash erythematous 79.43 10.40 142 53964 21420 29499001
Completed suicide 77.54 10.40 34 54072 90212 29430209
Fixed eruption 75.36 10.40 39 54067 1163 29519258
Drug abuse 70.37 10.40 29 54077 79854 29440567
Eyelid oedema 69.84 10.40 62 54044 4574 29515847
Enterocolitis haemorrhagic 69.38 10.40 33 54073 817 29519604
Swollen tongue 68.96 10.40 98 54008 12168 29508253
Tubulointerstitial nephritis 67.31 10.40 118 53988 17525 29502896
Toxic skin eruption 63.99 10.40 84 54022 9673 29510748
Drug ineffective 63.64 10.40 397 53709 362773 29157648
Tooth disorder 62.44 10.40 82 54024 9447 29510974
Tongue oedema 61.42 10.40 45 54061 2521 29517900
Swelling face 61.29 10.40 123 53983 20227 29500194
Toxicity to various agents 60.84 10.40 143 53963 173518 29346903
Rash morbilliform 55.82 10.40 42 54064 2451 29517970
Acute psychosis 55.53 10.40 36 54070 1651 29518770
Fall 54.32 10.40 156 53950 177022 29343399
Off label use 49.46 10.40 335 53771 300465 29219956
Disease progression 48.46 10.40 47 54059 81869 29438552
Premature baby 47.97 10.40 101 54005 17179 29503242
Crystal nephropathy 44.50 10.40 19 54087 362 29520059
Dermatitis exfoliative generalised 43.93 10.40 39 54067 2877 29517544
Type IV hypersensitivity reaction 43.50 10.40 27 54079 1147 29519274
Helicobacter test positive 43.00 10.40 22 54084 640 29519781
Malignant neoplasm progression 42.97 10.40 43 54063 73816 29446605
Serum sickness-like reaction 37.92 10.40 12 54094 92 29520329
Rash pruritic 37.79 10.40 108 53998 22255 29498166
Degenerative mitral valve disease 35.85 10.40 14 54092 210 29520211
Hepatitis cholestatic 35.72 10.40 53 54053 6840 29513581
Drug-induced liver injury 35.07 10.40 103 54003 21552 29498869
Ureteric compression 35.05 10.40 13 54093 168 29520253
Neutropenia neonatal 34.65 10.40 19 54087 638 29519783
Tooth demineralisation 34.65 10.40 7 54099 3 29520418
Febrile neutropenia 34.22 10.40 99 54007 112141 29408280
Foetal disorder 34.16 10.40 20 54086 763 29519658
Clostridium difficile colitis 34.12 10.40 75 54031 13137 29507284
Jaundice cholestatic 33.49 10.40 40 54066 4186 29516235
Conjunctival irritation 33.31 10.40 11 54095 98 29520323
Dyspnoea 33.08 10.40 806 53300 325926 29194495
Otospondylomegaepiphyseal dysplasia 32.83 10.40 11 54095 103 29520318
Liver injury 32.73 10.40 72 54034 12618 29507803
Hepatitis acute 32.51 10.40 49 54057 6413 29514008
Fatigue 32.31 10.40 398 53708 316423 29203998
Bradycardia 31.95 10.40 44 54062 65585 29454836
Factitious disorder 31.23 10.40 9 54097 48 29520373
Cardiac failure congestive 31.01 10.40 58 54048 76523 29443898
Malaise 30.99 10.40 436 53670 159166 29361255
Myocardial infarction 30.98 10.40 101 54005 110195 29410226
Bone disorder 30.74 10.40 45 54061 5738 29514683
Rash macular 30.18 10.40 62 54044 10363 29510058
Helicobacter infection 30.14 10.40 27 54079 2015 29518406
Rash vesicular 29.96 10.40 29 54077 2389 29518032
Rash papular 29.94 10.40 53 54053 7928 29512493
Laryngeal dyspnoea 29.91 10.40 10 54096 93 29520328
Dermatitis allergic 29.86 10.40 44 54062 5644 29514777
Mouth swelling 29.75 10.40 24 54082 1552 29518869
Drug eruption 29.41 10.40 82 54024 16659 29503762
Erythema multiforme 28.63 10.40 51 54055 7666 29512755
Documented hypersensitivity to administered product 28.28 10.40 12 54094 225 29520196
Skin test positive 28.13 10.40 13 54093 301 29520120
Mixed liver injury 28.09 10.40 26 54080 2025 29518396
Ureteral disorder 27.93 10.40 11 54095 169 29520252
Secondary amyloidosis 27.89 10.40 9 54097 74 29520347
Malignant mesenteric neoplasm 27.55 10.40 8 54098 44 29520377
Eye injury 27.36 10.40 16 54090 609 29519812
Jaundice 27.20 10.40 116 53990 29180 29491241
Conjunctival hyperaemia 27.09 10.40 26 54080 2119 29518302
Hepatic cytolysis 27.00 10.40 52 54054 8295 29512126
Injection site pain 26.64 10.40 13 54093 32433 29487988
Acute hepatic failure 26.62 10.40 64 54042 11888 29508533
Tachycardia foetal 26.32 10.40 12 54094 269 29520152
Urethral valves 26.24 10.40 12 54094 271 29520150
Conjunctivitis 26.08 10.40 50 54056 7948 29512473
Wheezing 25.92 10.40 125 53981 33115 29487306
Skin reaction 25.87 10.40 36 54070 4381 29516040
Pulmonary vascular disorder 25.87 10.40 15 54091 562 29519859
Nicotine dependence 25.46 10.40 14 54092 473 29519948
Therapeutic product effect decreased 25.42 10.40 11 54095 29440 29490981
Low birth weight baby 24.94 10.40 44 54062 6564 29513857
Penile erythema 24.90 10.40 10 54096 162 29520259
Laryngeal oedema 24.40 10.40 29 54077 3019 29517402
Jejunal ulcer perforation 24.36 10.40 8 54098 70 29520351
Dermatomyositis 24.23 10.40 18 54088 1030 29519391
Bronchospasm 24.19 10.40 54 54052 9555 29510866
Haemoglobin decreased 24.13 10.40 109 53997 108266 29412155
Cerebrovascular accident 24.04 10.40 67 54039 76844 29443577
Periorbital oedema 24.03 10.40 30 54076 3285 29517136
Ultrasound liver abnormal 24.01 10.40 9 54097 120 29520301
Attention-seeking behaviour 23.88 10.40 7 54099 40 29520381
Metastases to stomach 23.77 10.40 8 54098 76 29520345
Tooth infection 23.70 10.40 39 54067 5500 29514921
White blood cell count decreased 23.63 10.40 76 54030 83286 29437135
Cardiac aneurysm 23.34 10.40 16 54090 806 29519615
Ventricular enlargement 23.32 10.40 13 54093 451 29519970
Pyelocaliectasis 23.32 10.40 18 54088 1091 29519330
Sensation of foreign body 23.18 10.40 22 54084 1768 29518653
Vanishing bile duct syndrome 23.00 10.40 14 54092 574 29519847
Anaemia 22.94 10.40 246 53860 200705 29319716
Macroglossia 22.85 10.40 12 54094 369 29520052
Platelet count decreased 22.28 10.40 107 53999 104565 29415856
Purpura 22.26 10.40 51 54055 9181 29511240
Rheumatoid arthritis 22.01 10.40 16 54090 32136 29488285
Dermatitis bullous 21.87 10.40 39 54067 5867 29514554
Sensitisation 21.81 10.40 9 54097 157 29520264
Inferior vena cava dilatation 21.19 10.40 14 54092 663 29519758
Omental necrosis 21.14 10.40 6 54100 30 29520391
Rash scarlatiniform 21.12 10.40 8 54098 110 29520311
Weight increased 20.97 10.40 71 54035 76596 29443825
Hallucinations, mixed 20.89 10.40 24 54082 2409 29518012
Eastern Cooperative Oncology Group performance status 20.66 10.40 6 54100 33 29520388
Therapeutic product effect incomplete 20.52 10.40 25 54081 39280 29481141
Tissue infiltration 20.39 10.40 7 54099 71 29520350
Dental operation 20.35 10.40 11 54095 359 29520062
Gingivitis 20.34 10.40 26 54080 2916 29517505
Macule 20.30 10.40 16 54090 1000 29519421
Hyperglycaemia 19.88 10.40 20 54086 34267 29486154
Prothrombin time shortened 19.68 10.40 18 54088 1380 29519041
Tubulointerstitial nephritis and uveitis syndrome 19.41 10.40 7 54099 83 29520338
Toothache 19.35 10.40 36 54070 5596 29514825
Faeces pale 19.29 10.40 17 54089 1242 29519179
Pyrexia 19.00 10.40 673 53433 286949 29233472
Infective exacerbation of chronic obstructive airways disease 18.97 10.40 19 54087 1631 29518790
Laryngeal discomfort 18.95 10.40 8 54098 148 29520273
Oral mucosal blistering 18.91 10.40 19 54087 1638 29518783
Cardiac failure 18.71 10.40 78 54028 79209 29441212
Rash pustular 18.70 10.40 32 54074 4659 29515762
Henoch-Schonlein purpura 18.64 10.40 17 54089 1299 29519122
Rebound acid hypersecretion 18.63 10.40 7 54099 94 29520327
Cerebral infarction 18.62 10.40 11 54095 24664 29495757
Genital cyst 18.46 10.40 4 54102 4 29520417
Plica syndrome 18.46 10.40 4 54102 4 29520417
Melanocytic hyperplasia 18.46 10.40 4 54102 4 29520417
Occult blood 18.36 10.40 12 54094 558 29519863
Diarrhoea haemorrhagic 18.28 10.40 36 54070 5838 29514583
Hypersensitivity vasculitis 18.27 10.40 26 54080 3231 29517190
Product use issue 18.25 10.40 42 54064 51402 29469019
Rectal polyp 18.21 10.40 12 54094 566 29519855
Foetal exposure during pregnancy 18.11 10.40 115 53991 33752 29486669
Genital erythema 17.94 10.40 8 54098 170 29520251
Palatal oedema 17.90 10.40 13 54093 718 29519703
Alveolitis 17.85 10.40 18 54088 1558 29518863
Vomiting 17.75 10.40 511 53595 211749 29308672
Drug intolerance 17.57 10.40 39 54067 48340 29472081
Skin exfoliation 17.53 10.40 85 54021 22560 29497861
Sense of oppression 17.46 10.40 11 54095 480 29519941
Pharyngitis 17.31 10.40 39 54067 6944 29513477
Exposure during pregnancy 17.14 10.40 44 54062 8510 29511911
Haematoma muscle 16.86 10.40 14 54092 943 29519478
Maple syrup disease 16.84 10.40 4 54102 8 29520413
Dermatosis 16.75 10.40 9 54097 290 29520131
Infusion site induration 16.67 10.40 8 54098 202 29520219
Deep vein thrombosis 16.49 10.40 52 54054 57347 29463074
Pharyngeal oedema 16.48 10.40 34 54072 5700 29514721
Metastases to heart 16.46 10.40 7 54099 132 29520289
Maternal exposure during pregnancy 16.27 10.40 28 54078 4095 29516326
Blood creatine phosphokinase increased 16.25 10.40 31 54075 40613 29479808
Accessory auricle 16.23 10.40 4 54102 10 29520411
Exostosis of external ear canal 16.23 10.40 4 54102 10 29520411
Odynophagia 16.23 10.40 30 54076 4640 29515781
Coagulation factor decreased 16.21 10.40 6 54100 77 29520344
Body fat disorder 16.20 10.40 5 54101 35 29520386
Ileal perforation 15.95 10.40 12 54094 700 29519721
Inflammatory marker increased 15.93 10.40 26 54080 3641 29516780
Neutrophil count decreased 15.92 10.40 35 54071 43532 29476889
Tonsillar erythema 15.92 10.40 3 54103 0 29520421
Tongue discolouration 15.86 10.40 14 54092 1025 29519396
Eye swelling 15.79 10.40 43 54063 8614 29511807
Vesicoureteric reflux 15.64 10.40 7 54099 150 29520271
Hypocoagulable state 15.54 10.40 13 54093 885 29519536
Interstitial lung disease 15.41 10.40 54 54052 57664 29462757
Cheilitis 15.39 10.40 19 54087 2057 29518364
Morganella infection 15.38 10.40 10 54096 461 29519960
Heart rate decreased 15.06 10.40 14 54092 24898 29495523
Periostosis 15.02 10.40 4 54102 15 29520406
Agranulocytosis 14.79 10.40 75 54031 20265 29500156
Hepatitis 14.67 10.40 76 54030 20707 29499714
Cardiac arrest 14.65 10.40 94 54012 85497 29434924
Sepsis 14.57 10.40 179 53927 142503 29377918
Spinal muscular atrophy 14.32 10.40 8 54098 279 29520142
Balanoposthitis 14.30 10.40 13 54093 989 29519432
Breath sounds 14.26 10.40 4 54102 19 29520402
Liver function test abnormal 14.12 10.40 96 54010 28822 29491599
Congenital heart valve disorder 14.04 10.40 5 54101 57 29520364
Chest discomfort 13.96 10.40 137 53969 45846 29474575
Infusion related reaction 13.88 10.40 38 54068 43848 29476573
Encephalitis 13.85 10.40 34 54072 6396 29514025
Constipation 13.72 10.40 138 53968 114022 29406399
Chromaturia 13.71 10.40 53 54053 12749 29507672
Infusion site swelling 13.68 10.40 17 54089 1853 29518568
Lower respiratory tract infection 13.56 10.40 89 54017 26413 29494008
Maternal drugs affecting foetus 13.52 10.40 25 54081 3868 29516553
Dental caries 13.47 10.40 26 54080 4154 29516267
Loss of personal independence in daily activities 13.47 10.40 16 54090 25424 29494997
Crying 13.39 10.40 30 54076 5321 29515100
Tongue eruption 13.38 10.40 3 54103 4 29520417
Intentional product misuse 13.37 10.40 27 54079 34634 29485787
Erythema annulare 13.34 10.40 4 54102 25 29520396
Symmetrical drug-related intertriginous and flexural exanthema 13.13 10.40 7 54099 222 29520199
Allergy test positive 13.08 10.40 4 54102 27 29520394
Normocytic anaemia 12.83 10.40 17 54089 1975 29518446
Chronic kidney disease 12.82 10.40 112 53994 36304 29484117
Pleocytosis 12.81 10.40 9 54097 472 29519949
Osteonecrosis of jaw 12.80 10.40 62 54044 16448 29503973
Genital lesion 12.77 10.40 7 54099 235 29520186
Haematocrit decreased 12.63 10.40 21 54085 29001 29491420
Cerebral haemorrhage 12.54 10.40 24 54082 31402 29489019
Ligament sprain 12.39 10.40 20 54086 2775 29517646
Ischaemic stroke 12.23 10.40 7 54099 15970 29504451
Product use in unapproved indication 12.18 10.40 101 54005 86774 29433647
Substance-induced mood disorder 12.13 10.40 5 54101 87 29520334
Bronchial haemorrhage 12.05 10.40 10 54096 673 29519748
Factor V inhibition 11.97 10.40 6 54100 167 29520254
Nephritis 11.90 10.40 17 54089 2119 29518302
Pulmonary sequestration 11.89 10.40 4 54102 38 29520383
Cyanosis neonatal 11.79 10.40 7 54099 274 29520147
Helicobacter gastritis 11.79 10.40 12 54094 1050 29519371
Gastrooesophageal reflux disease 11.68 10.40 98 54008 31398 29489023
Blood pressure increased 11.66 10.40 83 54023 73720 29446701
Gastritis 11.52 10.40 68 54038 19449 29500972
Intervertebral disc degeneration 11.52 10.40 28 54078 5236 29515185
Epstein-Barr virus antibody positive 11.48 10.40 7 54099 288 29520133
Ear swelling 11.46 10.40 8 54098 415 29520006
Senile dementia 11.45 10.40 4 54102 43 29520378
Periodontal disease 11.42 10.40 10 54096 724 29519697
Clostridium difficile infection 11.37 10.40 59 54047 16082 29504339
Contraindicated product administered 11.36 10.40 10 54096 18256 29502165
Biliary sepsis 11.30 10.40 9 54097 571 29519850
Blood pressure systolic decreased 11.29 10.40 23 54083 3821 29516600
Serum sickness 11.27 10.40 15 54091 1750 29518671
Mental status changes 11.23 10.40 30 54076 34897 29485524
Orthostatic hypotension 11.18 10.40 15 54091 22614 29497807
Treatment failure 10.94 10.40 33 54073 36906 29483515
Therapeutic product ineffective for unapproved indication 10.92 10.40 3 54103 13 29520408
Dental care 10.90 10.40 6 54100 203 29520218
Blister 10.89 10.40 68 54038 19838 29500583
Patellofemoral pain syndrome 10.89 10.40 5 54101 114 29520307
Alveolar proteinosis 10.84 10.40 7 54099 319 29520102
Lymphadenitis 10.79 10.40 14 54092 1593 29518828
Throat tightness 10.79 10.40 33 54073 7058 29513363
Nasal neoplasm 10.77 10.40 5 54101 117 29520304
Stoma closure 10.77 10.40 5 54101 117 29520304
Abdominal pain upper 10.76 10.40 164 53942 60829 29459592
Pseudomembranous colitis 10.73 10.40 18 54088 2579 29517842
Otitis media acute 10.72 10.40 8 54098 461 29519960
Non-cardiogenic pulmonary oedema 10.69 10.40 9 54097 618 29519803
Abdominal wall haematoma 10.65 10.40 14 54092 1613 29518808
Enamel anomaly 10.65 10.40 5 54101 120 29520301
Myasthenia gravis 10.65 10.40 20 54086 3131 29517290
Mycoplasma test positive 10.62 10.40 5 54101 121 29520300
Tooth hypoplasia 10.62 10.40 5 54101 121 29520300
Hyperleukocytosis 10.60 10.40 14 54092 1621 29518800
Foetal distress syndrome 10.57 10.40 11 54095 988 29519433
Product dose omission issue 10.57 10.40 119 53987 96264 29424157
Binocular eye movement disorder 10.56 10.40 4 54102 55 29520366
Ischaemic cerebral infarction 10.52 10.40 11 54095 994 29519427
Resuscitation 10.48 10.40 12 54094 1200 29519221

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
Pruritus 837.52 9.73 1783 114865 310617 64071467
Drug reaction with eosinophilia and systemic symptoms 791.32 9.73 708 115940 53509 64328575
Rash maculo-papular 752.25 9.73 647 116001 46379 64335705
Urticaria 744.91 9.73 1111 115537 146206 64235878
Anaphylactic shock 640.87 9.73 491 116157 29837 64352247
Angioedema 560.11 9.73 623 116025 61198 64320886
Rash 510.25 9.73 1901 114747 456648 63925436
Erythema 507.28 9.73 1074 115574 185996 64196088
Drug hypersensitivity 448.54 9.73 1185 115463 236630 64145454
Cross sensitivity reaction 435.78 9.73 180 116468 3187 64378897
Acute generalised exanthematous pustulosis 424.67 9.73 283 116365 13775 64368309
Anaphylactic reaction 377.16 9.73 539 116109 68125 64313959
Lip oedema 376.06 9.73 185 116463 5004 64377080
Lip swelling 359.01 9.73 361 116287 31546 64350538
Face oedema 293.05 9.73 288 116360 24473 64357611
Type IV hypersensitivity reaction 269.04 9.73 129 116519 3293 64378791
Eosinophilia 250.01 9.73 326 116322 37750 64344334
Toxic skin eruption 248.38 9.73 235 116413 19049 64363035
Type I hypersensitivity 242.94 9.73 122 116526 3452 64378632
Hepatocellular injury 240.86 9.73 350 116298 44885 64337199
Drug ineffective 236.22 9.73 759 115889 839488 63542596
Crystalluria 230.93 9.73 78 116570 760 64381324
Acute kidney injury 229.30 9.73 1492 115156 447748 63934336
Completed suicide 215.09 9.73 69 116579 224345 64157739
Death 207.04 9.73 347 116301 482358 63899726
Wound closure 205.18 9.73 50 116598 119 64381965
Swollen tongue 204.61 9.73 283 116365 34671 64347413
Stevens-Johnson syndrome 200.04 9.73 277 116371 33972 64348112
Swelling face 197.58 9.73 371 116277 58795 64323289
Cholestasis 192.25 9.73 314 116334 44558 64337526
Osteotomy 192.09 9.73 50 116598 170 64381914
Meningitis aseptic 191.71 9.73 123 116525 5607 64376477
Tongue oedema 160.50 9.73 112 116536 5878 64376206
Toxic epidermal necrolysis 160.45 9.73 261 116387 36905 64345179
Enterocolitis haemorrhagic 156.74 9.73 75 116573 1905 64380179
Rash erythematous 152.57 9.73 297 116351 48336 64333748
Rash pruritic 147.64 9.73 323 116325 57081 64325003
Synovitis 146.46 9.73 8 116640 99082 64283002
Tubulointerstitial nephritis 144.34 9.73 225 116423 30684 64351400
Fall 131.44 9.73 356 116292 416470 63965614
Rash macular 122.76 9.73 181 116467 23504 64358580
Eyelid oedema 116.71 9.73 127 116521 12152 64369932
Rash morbilliform 114.64 9.73 86 116562 5055 64377029
Erythema multiforme 113.41 9.73 141 116507 15560 64366524
Drug abuse 109.69 9.73 51 116597 132323 64249761
Off label use 106.21 9.73 690 115958 632116 63749968
Toxicity to various agents 98.38 9.73 333 116315 363180 64018904
Jaundice 97.54 9.73 248 116400 48264 64333820
Fatigue 95.82 9.73 880 115768 747850 63634234
Infusion related reaction 88.61 9.73 100 116548 164367 64217717
Dermatitis exfoliative generalised 87.67 9.73 78 116570 5838 64376246
Rheumatoid arthritis 85.17 9.73 103 116545 164191 64217893
Fixed eruption 83.97 9.73 51 116597 2108 64379976
Cholecystitis chronic 82.99 9.73 93 116555 9194 64372890
Therapeutic product effect decreased 81.74 9.73 54 116594 115297 64266787
Hypersensitivity 78.02 9.73 615 116033 195837 64186247
Kounis syndrome 77.42 9.73 55 116593 2970 64379114
Hepatitis cholestatic 75.02 9.73 101 116547 12054 64370030
Dermatitis allergic 74.77 9.73 113 116535 14996 64367088
Hallucinations, mixed 74.59 9.73 72 116576 5980 64376104
Pemphigus 73.52 9.73 11 116637 60690 64321394
Malaise 73.28 9.73 1063 115585 395184 63986900
Arthropathy 72.59 9.73 67 116581 120900 64261184
Paraesthesia oral 71.90 9.73 103 116545 13028 64369056
Clostridium difficile infection 70.76 9.73 183 116465 35980 64346104
Hand deformity 70.27 9.73 14 116634 62757 64319327
Drug eruption 68.79 9.73 181 116467 35955 64346129
Injection site pain 67.68 9.73 61 116587 111347 64270737
Periorbital oedema 67.55 9.73 75 116573 7339 64374745
Laryngeal oedema 66.61 9.73 73 116575 7040 64375044
Contraindicated product administered 65.56 9.73 59 116589 107770 64274314
Febrile neutropenia 63.84 9.73 154 116494 187503 64194581
Throat tightness 63.75 9.73 134 116514 23026 64359058
Drug-induced liver injury 62.42 9.73 209 116439 47434 64334650
Product use issue 62.14 9.73 112 116536 151603 64230481
Bronchospasm 61.50 9.73 127 116521 21555 64360529
Crystal nephropathy 60.05 9.73 34 116614 1231 64380853
Systemic lupus erythematosus 59.64 9.73 33 116615 77579 64304505
Alopecia 58.74 9.73 133 116515 165557 64216527
Documented hypersensitivity to administered product 57.79 9.73 29 116619 819 64381265
Purpura 57.36 9.73 108 116540 17138 64364946
Vomiting 56.84 9.73 1350 115298 549767 63832317
Wheezing 56.76 9.73 292 116356 80287 64301797
Dental operation 54.62 9.73 29 116619 923 64381161
Clostridium difficile colitis 53.50 9.73 138 116510 27085 64354999
Arthralgia 52.87 9.73 528 116120 441732 63940352
Wound 52.57 9.73 37 116611 76440 64305644
Therapeutic product effect incomplete 52.42 9.73 66 116582 103416 64278668
Pericarditis 51.90 9.73 24 116624 62492 64319592
Drug intolerance 50.23 9.73 173 116475 187819 64194265
Weight increased 50.08 9.73 207 116441 213141 64168943
Hepatitis acute 49.79 9.73 88 116560 13301 64368783
Diarrhoea 48.87 9.73 1678 114970 721026 63661058
Malignant neoplasm progression 48.33 9.73 81 116567 112790 64269294
Injection site erythema 47.69 9.73 35 116613 70765 64311319
Tongue discolouration 47.14 9.73 43 116605 3325 64378759
Cardiac failure congestive 46.13 9.73 105 116543 130475 64251609
Dyspnoea 45.44 9.73 1656 114992 717018 63665066
Duodenal ulcer perforation 45.00 9.73 5 116643 34620 64347464
Agranulocytosis 44.27 9.73 161 116487 38068 64344016
Mouth swelling 43.69 9.73 50 116598 5057 64377027
Treatment failure 43.68 9.73 91 116557 116725 64265359
Dermatitis bullous 43.25 9.73 78 116570 11976 64370108
Acute hepatic failure 42.96 9.73 124 116524 25988 64356096
Loss of personal independence in daily activities 42.43 9.73 41 116607 72413 64309671
Pseudomembranous colitis 41.83 9.73 48 116600 4868 64377216
Discomfort 41.57 9.73 51 116597 80827 64301257
Skin test positive 41.28 9.73 25 116623 1028 64381056
Emotional distress 40.24 9.73 150 116498 35888 64346196
Bradycardia 40.20 9.73 97 116551 118122 64263962
Injury 40.19 9.73 204 116444 55788 64326296
Skin reaction 39.41 9.73 76 116572 12276 64369808
Helicobacter test positive 38.70 9.73 24 116624 1030 64381054
Joint swelling 38.46 9.73 230 116418 215152 64166932
Hepatitis 38.46 9.73 174 116474 45408 64336676
Hepatic cytolysis 38.33 9.73 81 116567 13968 64368116
Palatal oedema 38.33 9.73 25 116623 1172 64380912
Otospondylomegaepiphyseal dysplasia 38.19 9.73 10 116638 35 64382049
Rash papular 38.11 9.73 91 116557 17022 64365062
Acute psychosis 37.75 9.73 40 116608 3712 64378372
Eczema 37.71 9.73 129 116519 29591 64352493
Mixed liver injury 37.63 9.73 48 116600 5433 64376651
Interstitial lung disease 37.50 9.73 75 116573 97657 64284427
Basilar artery occlusion 37.48 9.73 14 116634 187 64381897
Chromaturia 36.83 9.73 107 116541 22504 64359580
Hyperleukocytosis 36.56 9.73 30 116618 2010 64380074
Symmetrical drug-related intertriginous and flexural exanthema 35.86 9.73 19 116629 602 64381482
Injection site swelling 35.70 9.73 15 116633 41338 64340746
Platelet count decreased 35.55 9.73 169 116479 167542 64214542
Glossodynia 35.18 9.73 39 116609 64657 64317427
Ureteric compression 35.05 9.73 13 116635 170 64381914
Jaundice cholestatic 34.87 9.73 59 116589 8611 64373473
Skin candida 34.70 9.73 27 116621 1676 64380408
Vascular purpura 34.54 9.73 32 116616 2524 64379560
Lymphadenopathy 34.14 9.73 171 116477 46515 64335569
Degenerative mitral valve disease 34.14 9.73 14 116634 243 64381841
Macule 34.00 9.73 31 116617 2395 64379689
Eye swelling 33.98 9.73 103 116545 22178 64359906
Laryngeal discomfort 33.81 9.73 17 116631 482 64381602
Myocardial infarction 33.47 9.73 170 116478 165651 64216433
Anaemia 33.37 9.73 483 116165 378197 64003887
Bone disorder 32.97 9.73 85 116563 16674 64365410
Pharyngeal oedema 32.89 9.73 81 116567 15450 64366634
Odynophagia 32.84 9.73 61 116587 9580 64372504
Disease progression 32.28 9.73 139 116509 141541 64240543
Serum sickness-like reaction 32.25 9.73 17 116631 533 64381551
Biliary sepsis 32.09 9.73 24 116624 1404 64380680
Abdominal pain 31.42 9.73 763 115885 311612 64070472
Conjunctival irritation 31.05 9.73 11 116637 125 64381959
Conjunctivitis 30.95 9.73 94 116554 20260 64361824
Depressed level of consciousness 29.97 9.73 64 116584 81372 64300712
Blood pressure increased 29.89 9.73 186 116462 172366 64209718
Tooth infection 29.71 9.73 75 116573 14526 64367558
Liver injury 29.68 9.73 120 116528 29812 64352272
Tubulointerstitial nephritis and uveitis syndrome 29.52 9.73 13 116635 271 64381813
Muscle injury 29.37 9.73 6 116642 26431 64355653
Tongue coated 29.31 9.73 21 116627 1149 64380935
Moraxella test positive 29.23 9.73 7 116641 15 64382069
Impaired healing 29.16 9.73 40 116608 60433 64321651
Rash pustular 28.15 9.73 58 116590 9827 64372257
Intentional product use issue 28.07 9.73 84 116564 95280 64286804
Cardiac failure 27.69 9.73 134 116514 132239 64249845
Cheilitis 27.69 9.73 38 116610 4618 64377466
Folliculitis 27.47 9.73 10 116638 30067 64352017
Stomatitis 27.18 9.73 104 116544 109501 64272583
Oral discomfort 27.16 9.73 52 116596 8354 64373730
Allergy to chemicals 26.87 9.73 19 116629 1018 64381066
Peritonsillar abscess 26.73 9.73 17 116631 763 64381321
Henoch-Schonlein purpura 26.73 9.73 26 116622 2180 64379904
Conjunctival hyperaemia 26.54 9.73 34 116614 3865 64378219
Drug interaction 26.46 9.73 849 115799 361234 64020850
Skin exfoliation 26.45 9.73 155 116493 44730 64337354
Mobility decreased 26.44 9.73 74 116574 85766 64296318
Malignant mesenteric neoplasm 26.38 9.73 8 116640 53 64382031
Macroglossia 26.31 9.73 19 116629 1053 64381031
Pain 26.14 9.73 782 115866 552729 63829355
Somatic delusion 26.07 9.73 16 116632 674 64381410
Injection site haemorrhage 25.97 9.73 6 116642 24272 64357812
Liver function test abnormal 25.80 9.73 190 116458 59211 64322873
SJS-TEN overlap 25.77 9.73 14 116634 467 64381617
Tinnitus 25.65 9.73 126 116522 34007 64348077
Lip erosion 25.46 9.73 20 116628 1259 64380825
Salpingo-oophorectomy unilateral 25.37 9.73 14 116634 482 64381602
Swelling of eyelid 25.01 9.73 25 116623 2167 64379917
Hepatic ischaemia 24.82 9.73 18 116630 1004 64381080
Muscle relaxant therapy 24.79 9.73 10 116638 166 64381918
Ventricular enlargement 24.67 9.73 14 116634 509 64381575
Secondary amyloidosis 24.38 9.73 9 116639 116 64381968
Lymphadenitis 24.20 9.73 32 116616 3753 64378331
Abdominal discomfort 24.15 9.73 212 116436 182110 64199974
Pain in extremity 24.15 9.73 394 116254 302691 64079393
General physical health deterioration 23.97 9.73 245 116403 204180 64177904
Therapeutic response decreased 23.70 9.73 36 116612 52152 64329932
Thermal burn 23.50 9.73 40 116608 5866 64376218
Rash vesicular 23.27 9.73 36 116612 4874 64377210
Pyelocaliectasis 23.23 9.73 16 116632 822 64381262
Pyrexia 23.13 9.73 1233 115415 557411 63824673
Dermatitis exfoliative 23.00 9.73 55 116593 10297 64371787
Knee arthroplasty 22.98 9.73 10 116638 26989 64355095
Chronic sinusitis 22.94 9.73 41 116607 6251 64375833
Factitious disorder 22.91 9.73 9 116639 139 64381945
Oral mucosal blistering 22.89 9.73 37 116611 5200 64376884
Penile erythema 22.85 9.73 9 116639 140 64381944
Inferior vena cava dilatation 22.33 9.73 15 116633 739 64381345
Product dose omission issue 22.18 9.73 235 116413 194512 64187572
Multiple sclerosis relapse 22.14 9.73 25 116623 41110 64340974
Rash scarlatiniform 21.97 9.73 10 116638 226 64381858
Fluid retention 21.80 9.73 47 116601 59559 64322525
Medication error 21.80 9.73 160 116488 49806 64332278
Pulmonary vascular disorder 21.74 9.73 16 116632 913 64381171
Mental status changes 21.73 9.73 49 116599 61113 64320971
Normal tension glaucoma 21.62 9.73 7 116641 59 64382025
Breast cancer 21.52 9.73 13 116635 29135 64352949
Injection site pruritus 21.46 9.73 22 116626 37804 64344280
Orthostatic hypotension 21.46 9.73 32 116616 46706 64335378
Nasopharyngitis 21.37 9.73 239 116409 195834 64186250
Cardiac arrest 21.36 9.73 177 116471 153887 64228197
Nicotine dependence 21.29 9.73 15 116633 799 64381285
Musculoskeletal stiffness 21.23 9.73 133 116515 123073 64259011
Oedema 21.22 9.73 257 116391 91678 64290406
Jejunal ulcer perforation 21.21 9.73 8 116640 110 64381974
Flank pain 21.18 9.73 71 116577 16118 64365966
White blood cell count decreased 21.14 9.73 183 116465 157654 64224430
Pleural effusion 21.10 9.73 138 116510 126421 64255663
Intentional product misuse 21.05 9.73 64 116584 72231 64309853
Cell death 21.03 9.73 31 116617 4023 64378061
Laryngeal dyspnoea 20.93 9.73 10 116638 253 64381831
Urinary tract infection 20.86 9.73 294 116354 231302 64150782
International normalised ratio increased 20.83 9.73 227 116421 78940 64303144
Influenza B virus test positive 20.72 9.73 11 116637 350 64381734
Hyperaemia 20.65 9.73 25 116623 2684 64379400
Sputum increased 20.62 9.73 29 116619 3606 64378478
Osteonecrosis of jaw 20.62 9.73 133 116515 39692 64342392
Sedation 20.42 9.73 27 116621 41435 64340649
Pharyngitis 20.22 9.73 78 116570 18961 64363123
Eastern Cooperative Oncology Group performance status 20.15 9.73 6 116642 37 64382047
Faeces pale 20.04 9.73 24 116624 2547 64379537
Pharyngeal swelling 19.98 9.73 36 116612 5523 64376561
Gallbladder disorder 19.95 9.73 72 116576 16958 64365126
Ureteral disorder 19.82 9.73 12 116636 493 64381591
Haemolytic anaemia 19.77 9.73 69 116579 15984 64366100
Pulmonary artery stenosis congenital 19.68 9.73 5 116643 15 64382069
Prothrombin time ratio decreased 19.66 9.73 14 116634 759 64381325
Inappropriate schedule of product administration 19.54 9.73 93 116555 92193 64289891
Infective exacerbation of chronic obstructive airways disease 19.40 9.73 23 116625 2415 64379669
Device expulsion 19.35 9.73 7 116641 21129 64360955
Vanishing bile duct syndrome 19.25 9.73 17 116631 1260 64380824
Omental necrosis 19.14 9.73 6 116642 45 64382039
Nephritis 19.09 9.73 28 116620 3618 64378466
Localised oedema 19.09 9.73 41 116607 7150 64374934
Neutropenic sepsis 19.00 9.73 88 116560 23184 64358900
Cardiac aneurysm 19.00 9.73 17 116631 1282 64380802
Serum sickness 18.92 9.73 26 116622 3163 64378921
Oxygen saturation decreased 18.82 9.73 115 116533 107061 64275023
Dysphonia 18.81 9.73 146 116502 46236 64335848
Sensation of foreign body 18.69 9.73 31 116617 4451 64377633
Abnormal faeces 18.63 9.73 36 116612 5823 64376261
Sinusitis fungal 18.62 9.73 19 116629 1687 64380397
Visual snow syndrome 18.57 9.73 5 116643 20 64382064
Plica syndrome 18.50 9.73 4 116644 4 64382080
Myelosuppression 18.49 9.73 10 116638 23820 64358264
Ill-defined disorder 18.49 9.73 32 116616 44020 64338064
Choluria 18.31 9.73 10 116638 337 64381747
Abdominal wall haematoma 18.26 9.73 30 116618 4275 64377809
Right ventricular failure 18.20 9.73 8 116640 21463 64360621
Tryptase increased 18.19 9.73 11 116637 451 64381633
Pharyngeal erythema 18.14 9.73 19 116629 1740 64380344
Prothrombin time shortened 18.08 9.73 24 116624 2825 64379259
Blood pressure fluctuation 18.07 9.73 42 116606 51829 64330255
Chronic kidney disease 18.07 9.73 172 116476 57747 64324337
Cerebral infarction 17.98 9.73 29 116619 41015 64341069
Red blood cell sedimentation rate increased 17.91 9.73 18 116630 31217 64350867
Mouth ulceration 17.82 9.73 110 116538 32334 64349750
Tooth disorder 17.77 9.73 84 116564 22318 64359766
Attention-seeking behaviour 17.76 9.73 7 116641 109 64381975
Device malfunction 17.63 9.73 5 116643 17628 64364456
Peripheral swelling 17.62 9.73 269 116379 208884 64173200
Cardio-respiratory arrest 17.58 9.73 105 116543 98288 64283796
Pharyngotonsillitis 17.47 9.73 9 116639 269 64381815
Excessive eye blinking 17.46 9.73 16 116632 1244 64380840
Ultrasound liver abnormal 17.45 9.73 8 116640 184 64381900
Lip pain 17.35 9.73 19 116629 1830 64380254
Otitis media acute 17.22 9.73 15 116633 1091 64380993
Feeling hot 17.03 9.73 141 116507 45522 64336562
Maple syrup disease 16.89 9.73 4 116644 8 64382076
Psoriatic arthropathy 16.78 9.73 33 116615 43248 64338836
Inflammatory marker increased 16.77 9.73 43 116605 8408 64373676
Irritable bowel syndrome 16.75 9.73 26 116622 37343 64344741
Small intestinal obstruction 16.74 9.73 11 116637 23562 64358522
Hypersensitivity myocarditis 16.72 9.73 6 116642 71 64382013
Hepatic necrosis 16.69 9.73 43 116605 8430 64373654
Injection site rash 16.62 9.73 4 116644 15738 64366346
Jarisch-Herxheimer reaction 16.46 9.73 12 116636 675 64381409
Bipolar I disorder 16.28 9.73 18 116630 1753 64380331
Exostosis of external ear canal 16.28 9.73 4 116644 10 64382074
Genital erythema 16.24 9.73 8 116640 217 64381867
Urinary retention 16.22 9.73 41 116607 49160 64332924
Haematuria 16.18 9.73 174 116474 60297 64321787
Acute respiratory failure 16.16 9.73 42 116606 49892 64332192
Pneumopericardium 16.07 9.73 7 116641 142 64381942
Gait disturbance 16.05 9.73 217 116431 171938 64210146
Neuroleptic malignant syndrome 16.01 9.73 13 116635 24983 64357101
Melanocytic hyperplasia 16.00 9.73 4 116644 11 64382073
Disseminated intravascular coagulation 15.99 9.73 21 116627 32327 64349757
Underdose 15.85 9.73 14 116634 25815 64356269
Blood glucose increased 15.81 9.73 108 116540 97965 64284119
Drug withdrawal syndrome 15.79 9.73 20 116628 31271 64350813
Contusion 15.76 9.73 131 116517 113834 64268250
Hypertransaminasaemia 15.75 9.73 38 116610 7153 64374931
Toothache 15.75 9.73 68 116580 17391 64364693
Tongue eruption 15.74 9.73 6 116642 85 64381999
Dysentery 15.74 9.73 13 116635 879 64381205
Palatal swelling 15.72 9.73 7 116641 150 64381934
Candida infection 15.70 9.73 104 116544 31315 64350769
Hepatic failure 15.58 9.73 161 116487 55233 64326851
Premature baby 15.52 9.73 24 116624 3248 64378836
Encephalitis 15.45 9.73 54 116594 12517 64369567
Body fat disorder 15.43 9.73 7 116641 157 64381927
Therapy non-responder 15.40 9.73 64 116584 65835 64316249
Fear-related avoidance of activities 15.37 9.73 6 116642 91 64381993
Accidental exposure to product 15.34 9.73 15 116633 26349 64355735
Polymenorrhagia 15.25 9.73 5 116643 44 64382040
Neoplasm progression 15.23 9.73 32 116616 40932 64341152
Metastases to stomach 15.20 9.73 8 116640 250 64381834
Condition aggravated 15.19 9.73 536 116112 371890 64010194
Actinomycosis 15.12 9.73 13 116635 929 64381155
Pharyngeal paraesthesia 15.12 9.73 18 116630 1899 64380185
Incorrect route of product administration 15.07 9.73 12 116636 23286 64358798
Periostosis 15.06 9.73 4 116644 15 64382069
Foot fracture 15.02 9.73 7 116641 18150 64363934
Dysphagia 14.98 9.73 274 116374 106538 64275546
Genital erosion 14.97 9.73 9 116639 365 64381719
Chest discomfort 14.96 9.73 294 116354 115812 64266272
Ear swelling 14.91 9.73 15 116633 1310 64380774
Hypertension 14.89 9.73 356 116292 258905 64123179
PRIDE syndrome 14.86 9.73 4 116644 16 64382068
Tooth discolouration 14.85 9.73 13 116635 952 64381132
Dermatosis 14.83 9.73 10 116638 496 64381588
Balanoposthitis 14.78 9.73 12 116636 792 64381292
Cytomegalovirus infection 14.74 9.73 28 116620 37171 64344913
Diabetes mellitus 14.66 9.73 66 116582 66408 64315676
Adverse event 14.55 9.73 31 116617 39458 64342626
Poisoning 14.49 9.73 11 116637 21868 64360216
Myasthenia gravis 14.42 9.73 32 116616 5706 64376378
Staphylococcal scalded skin syndrome 14.41 9.73 9 116639 391 64381693
Crepitations 14.41 9.73 39 116609 7876 64374208
Fracture 14.37 9.73 8 116640 18747 64363337
Femoral artery embolism 14.34 9.73 5 116643 54 64382030
Sebaceous gland infection 14.33 9.73 6 116642 110 64381974
Hepatic enzyme increased 14.30 9.73 158 116490 129785 64252299
Palpitations 14.29 9.73 267 116381 104221 64277863
Spinal muscular atrophy 14.22 9.73 8 116640 286 64381798
Substance-induced mood disorder 14.18 9.73 6 116642 113 64381971
Enamel anomaly 14.13 9.73 6 116642 114 64381970
Skin swelling 14.13 9.73 21 116627 2745 64379339
Pruritus genital 14.10 9.73 13 116635 1019 64381065
Eye injury 14.06 9.73 16 116632 1608 64380476
Wrong technique in product usage process 14.03 9.73 65 116583 64909 64317175
Full blood count abnormal 14.02 9.73 20 116628 29737 64352347
Caffeine allergy 13.98 9.73 4 116644 21 64382063
Forced vital capacity abnormal 13.98 9.73 4 116644 21 64382063
Labile blood pressure 13.94 9.73 18 116630 2062 64380022
Cognitive disorder 13.83 9.73 52 116596 55035 64327049
Delayed delivery 13.67 9.73 4 116644 23 64382061
Ileal perforation 13.65 9.73 12 116636 884 64381200
Gamma-glutamyltransferase increased 13.65 9.73 141 116507 48369 64333715
Pseudomyopia 13.58 9.73 5 116643 64 64382020
Serotonin syndrome 13.53 9.73 32 116616 39250 64342834
Gastritis 13.51 9.73 127 116521 42491 64339593
Overdose 13.51 9.73 205 116443 159361 64222723
Enanthema 13.50 9.73 11 116637 730 64381354
Pneumonia 13.49 9.73 852 115796 558724 63823360
Posterior reversible encephalopathy syndrome 13.41 9.73 13 116635 22933 64359151
Coma 13.38 9.73 98 116550 87517 64294567
Papule 13.32 9.73 33 116615 6317 64375767
Cholestasis of pregnancy 13.32 9.73 12 116636 913 64381171
Eosinophils urine present 13.30 9.73 5 116643 68 64382016
Sepsis 13.30 9.73 316 116332 230025 64152059
Sensitisation 13.23 9.73 16 116632 1715 64380369
Infectious mononucleosis 13.22 9.73 16 116632 1717 64380367
Fibromyalgia 13.21 9.73 28 116620 35703 64346381
Injection site warmth 13.12 9.73 4 116644 13458 64368626
Injection site reaction 13.09 9.73 42 116606 46622 64335462
Pneumonia mycoplasmal 13.01 9.73 14 116634 1322 64380762
Dyspnoea exertional 13.00 9.73 79 116569 73651 64308433
Musculoskeletal pain 12.87 9.73 90 116558 81204 64300880
Budd-Chiari syndrome 12.86 9.73 5 116643 75 64382009
Asthenia 12.82 9.73 638 116010 427406 63954678
Tongue pruritus 12.78 9.73 9 116639 479 64381605
Somnolence 12.71 9.73 276 116372 203369 64178715
Linear IgA disease 12.68 9.73 20 116628 2754 64379330
Respiratory arrest 12.67 9.73 51 116597 52934 64329150
Ear infection 12.63 9.73 79 116569 23325 64358759
Oropharyngeal discomfort 12.56 9.73 29 116619 5306 64376778
Anaphylactoid reaction 12.56 9.73 27 116621 4711 64377373
Electrocardiogram QT prolonged 12.55 9.73 88 116560 79360 64302724
Transplant rejection 12.52 9.73 8 116640 17393 64364691
Drug dependence 12.40 9.73 26 116622 33286 64348798
Coagulation factor decreased 12.37 9.73 6 116642 157 64381927
Vasculitis 12.34 9.73 65 116583 18030 64364054
Progressive multifocal leukoencephalopathy 12.29 9.73 9 116639 18223 64363861
Atrial septal defect 12.18 9.73 15 116633 1638 64380446
Bone erosion 12.14 9.73 3 116645 11592 64370492
Biliary dyskinesia 12.11 9.73 18 116630 2354 64379730
Metastases to central nervous system 12.08 9.73 5 116643 13907 64368177
Glomerulonephritis acute 12.07 9.73 6 116642 166 64381918
Glycosylated haemoglobin increased 12.03 9.73 7 116641 16012 64366072
Pulmonary arterial hypertension 12.00 9.73 17 116631 25350 64356734
Biliary colic 11.99 9.73 22 116626 3422 64378662
Blood alkaline phosphatase increased 11.99 9.73 155 116493 56124 64325960
Pericardial effusion 11.97 9.73 34 116614 39220 64342864
Hypoaesthesia oral 11.94 9.73 47 116601 11533 64370551
Abdominal pain upper 11.88 9.73 407 116241 174623 64207461
Personal relationship issue 11.84 9.73 6 116642 173 64381911
Pneumonia aspiration 11.81 9.73 61 116587 59210 64322874
Transaminases increased 11.78 9.73 128 116520 44466 64337618
Rectal polyp 11.72 9.73 13 116635 1271 64380813
Cerebral haemorrhage 11.70 9.73 50 116598 51040 64331044
Respiratory failure 11.70 9.73 213 116435 160970 64221114
Lung neoplasm malignant 11.58 9.73 13 116635 21435 64360649
Respiratory tract oedema 11.57 9.73 10 116638 720 64381364
Hyperglycaemia 11.46 9.73 64 116584 60904 64321180
Allergy test positive 11.33 9.73 8 116640 428 64381656
Tendon disorder 11.33 9.73 31 116617 6301 64375783
Subarachnoid haemorrhage 11.31 9.73 10 116638 18428 64363656
Analgesic drug level increased 11.26 9.73 17 116631 2253 64379831
Mucosal discolouration 11.21 9.73 10 116638 751 64381333
Post-traumatic stress disorder 11.19 9.73 24 116624 4181 64377903
Chapped lips 11.18 9.73 16 116632 2022 64380062
Osteogenesis imperfecta 11.13 9.73 6 116642 197 64381887
Lymphocytosis 11.11 9.73 22 116626 3622 64378462
Mycoplasma test positive 10.97 9.73 6 116642 203 64381881
Product complaint 10.87 9.73 4 116644 11950 64370134
Epigastric discomfort 10.87 9.73 32 116616 6779 64375305
Arthritis 10.85 9.73 98 116550 83716 64298368
Femur fracture 10.83 9.73 29 116619 34106 64347978
Acquired haemophilia 10.83 9.73 14 116634 1606 64380478
Erythema nodosum 10.82 9.73 23 116625 3981 64378103
Bleeding time prolonged 10.81 9.73 12 116636 1174 64380910
Pharyngeal abscess 10.79 9.73 9 116639 617 64381467
Tonsillar erythema 10.77 9.73 3 116645 14 64382070
Prescribed underdose 10.77 9.73 10 116638 18005 64364079
Electric shock sensation 10.72 9.73 7 116641 329 64381755
Periorbital swelling 10.69 9.73 15 116633 1861 64380223
Tongue dry 10.67 9.73 11 116637 989 64381095
Intestinal obstruction 10.65 9.73 32 116616 36254 64345830
Nail dystrophy 10.64 9.73 10 116638 803 64381281
Allergy test negative 10.60 9.73 3 116645 15 64382069
Lower gastrointestinal haemorrhage 10.60 9.73 6 116642 13933 64368151
Systolic dysfunction 10.58 9.73 20 116628 3182 64378902
Female genital tract fistula 10.57 9.73 18 116630 2640 64379444
Prurigo 10.55 9.73 12 116636 1205 64380879
Target skin lesion 10.52 9.73 5 116643 125 64381959
Genital cyst 10.47 9.73 4 116644 57 64382027
Metastases to heart 10.43 9.73 6 116642 224 64381860
Psychotic behaviour 10.41 9.73 11 116637 1018 64381066
Colon cancer 10.40 9.73 5 116643 12734 64369350
Genital lesion 10.37 9.73 8 116640 490 64381594
Stoma closure 10.27 9.73 5 116643 132 64381952
Iris transillumination defect 10.24 9.73 5 116643 133 64381951
Tonsillitis streptococcal 10.17 9.73 5 116643 135 64381949
Ascites 10.13 9.73 68 116580 61933 64320151
Acute febrile neutrophilic dermatosis 10.03 9.73 20 116628 3309 64378775
Bone pain 10.03 9.73 48 116600 47524 64334560
Gait inability 9.99 9.73 41 116607 42327 64339757
Klebsiella infection 9.96 9.73 49 116599 13232 64368852
Tonsillitis 9.92 9.73 28 116620 5792 64376292
Clostridium colitis 9.91 9.73 17 116631 2508 64379576
Tonsillar hypertrophy 9.90 9.73 12 116636 1289 64380795
Eosinophilic pneumonia acute 9.90 9.73 10 116638 877 64381207
Pneumococcal sepsis 9.88 9.73 12 116636 1292 64380792
COVID-19 9.88 9.73 73 116575 65067 64317017
Creatinine renal clearance decreased 9.88 9.73 7 116641 14414 64367670
Myelodysplastic syndrome 9.87 9.73 22 116626 27557 64354527
Dermatomyositis 9.87 9.73 18 116630 2788 64379296
Injection site mass 9.85 9.73 10 116638 17260 64364824
Second primary malignancy 9.84 9.73 5 116643 12332 64369752
Fibrous histiocytoma 9.82 9.73 8 116640 531 64381553
Pulmonary oedema 9.75 9.73 93 116555 78581 64303503

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
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 A02BD16 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 J01CA04 ANTIINFECTIVES FOR SYSTEMIC USE
ANTIBACTERIALS FOR SYSTEMIC USE
BETA-LACTAM ANTIBACTERIALS, PENICILLINS
Penicillins with extended spectrum
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




๐Ÿถ Veterinary Drug Use

SpeciesUseRelation
Cats Upper respiratory tract infections caused by Staphylococcus aureus Indication
Cats Upper respiratory tract infections caused by Streptococcus spp Indication
Cats Upper respiratory tract infections caused by Escherichia coli Indication
Cats Gastrointestinal tract infections caused by Escherichia coli Indication
Cats Genitourinary tract infections caused by Staphylococcus aureus Indication
Cats Genitourinary tract infections caused by Streptococcus spp Indication
Cats Genitourinary tract infections caused by Escherichia coli Indication
Cats Genitourinary tract infections caused by Proteus species Indication
Cats Skin and soft tissue infections caused by Staphylococcus spp Indication
Cats Skin and soft tissue infections caused by Streptococcus spp Indication
Cats Skin and soft tissue infections caused by Escherichia coli Indication
Cats Skin and soft tissue infectionscaused by Pasteurella multocida Indication
Cattle Bacterial enteritis caused by susceptible Escherichia coli Indication
Cattle Respiratory tract infections caused by Pasteurella multocida Indication
Cattle Respiratory tract infections caused by P hemolytica Indication
Cattle Respiratory tract infections caused by Hemophilus species Indication
Cattle Respiratory tract infections caused by Staphylococci species Indication
Cattle Respiratory tract infections caused by Streptococci species and Indication
Cattle Necrotic pododermatitis (foot rot) caused by Fusobacterium necrophorum Indication
Cattle Bovine mastitis caused by Streptococcus agalactiae Indication
Cattle Bovine mastitis caused by Staphylococcus aureus Indication
Dogs Respiratory tract infection caused by Staphylococcus aureus Indication
Dogs Respiratory tract infections caused by Streptococcus spp Indication
Dogs Respiratory tract infections caused by Escherichia coli Indication
Dogs Respiratory tract infections caused by Proteus mirabilis Indication
Dogs Urinary tract infections caused by Staphylococcus aureus Indication
Dogs Urinary tract infections caused by Streptococcus spp Indication
Dogs Urinary tract infections caused by Escherichia coli Indication
Dogs Urinary tract infections caused by Proteus mirabilis Indication
Dogs Soft tissue infections caused by Staphylococcus aureus Indication
Dogs Soft tissue infections caused by Streptococcus spp Indication
Dogs Soft tissue infections caused by Escherichia coli Indication
Dogs Soft tissue infections caused by Proteus mirabilis Indication
Dogs Bacterial dermatitis caused by Staphylococcus aureus Indication
Dogs Bacterial dermatitis caused by Streptococcus spp Indication
Dogs Bacterial dermatitis caused by Proteus mirabilis Indication
Swine PorcinEscherichia colibacillosis caused by Escherichia coli Indication

๐Ÿถ Veterinary products

ProductApplicantIngredients
Amoxi-Tabs Zoetis Inc. 1
Amoxi-Doser Zoetis Inc. 1
Amoxi-Tabs Zoetis Inc. 1
Amoxi-Drop Oral Suspension Zoetis Inc. 1
Amoxi-Bol Zoetis Inc. 1
Amoxi-Sol Zoetis Inc. 1
Amoxi-Inject (Cattle) Zoetis Inc. 1
Amoxi-Inject (Dogs and Cats) Zoetis Inc. 1
CLAVAMOX CHEWABLE Tablets, CLAVAMOX tablets Zoetis Inc. 2
CLAVAMOX CHEWABLE Tablets, CLAVAMOX tablets Zoetis Inc. 2
Amoxi-Mast Intervet Inc. 1
Clavamox Drops Zoetis Inc. 2
Biomox, Robamox-V Tablets Virbac AH Inc. 1
Biomox, Robamox-V Virbac AH Inc. 1
Robamox-V Zoetis Inc. 1
Robamox-V Tablets Zoetis Inc. 1
Clavacillin Dechra Veterinary Products LLC 2
Amoxicillin and Clavulanate Potassium for Oral Suspension Dechra Veterinary Products LLC 2
Amoxicillin and Clavulanate Potassium Tablets Cronus Pharma Specialities India Private Limited 2
Amoxicillin and Clavulanate Potassium for Oral Suspension Cronus Pharma Specialities India Private Limited 2

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)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
775MG MOXATAG PRAGMA N050813 Jan. 23, 2008 DISCN TABLET, EXTENDED RELEASE ORAL 8778924 Dec. 8, 2026 METHOD OF TREATING TONSILLITIS AND/OR PHARYNGITIS SECONDARY TO STREPTOCOCCUS PYOGENES IN A ONCE-A-DAY AMOXICILLIN PRODUCT
775MG MOXATAG PRAGMA N050813 Jan. 23, 2008 DISCN TABLET, EXTENDED RELEASE ORAL 8299052 May 7, 2027 USE OF ONCE-A-DAY AMOXICILLIN PRODUCT TO TREAT TONSILLITIS AND/OR PHARYNGITIS SECONDARY TO STREPTOCOCCUS PYOGENES
250MG;EQ 10MG BASE;12.5MG TALICIA REDHILL N213004 Nov. 1, 2019 RX CAPSULE, DELAYED RELEASE ORAL 11135172 Feb. 12, 2034 TREATMENT OF H. PYLORI INFECTION IN ADULTS
250MG;EQ 10MG BASE;12.5MG TALICIA REDHILL N213004 Nov. 1, 2019 RX CAPSULE, DELAYED RELEASE ORAL 9050263 Feb. 12, 2034 TREATMENT OF H. PYLORI INFECTION IN ADULTS
250MG;EQ 10MG BASE;12.5MG TALICIA REDHILL N213004 Nov. 1, 2019 RX CAPSULE, DELAYED RELEASE ORAL 9498445 Feb. 12, 2034 TREATMENT OF H. PYLORI INFECTION IN ADULTS
250MG;EQ 10MG BASE;12.5MG TALICIA REDHILL N213004 Nov. 1, 2019 RX CAPSULE, DELAYED RELEASE ORAL 9603806 Feb. 12, 2034 TREATMENT OF H. PYLORI INFECTION IN ADULTS

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 RX CAPSULE, TABLET, TABLET ORAL May 3, 2027 NEW CHEMICAL ENTITY
500MG;EQ 20MG BASE VOQUEZNA DUAL PAK PHATHOM N215153 May 3, 2022 RX CAPSULE, TABLET ORAL May 3, 2027 NEW CHEMICAL ENTITY
500MG;500MG;EQ 20MG BASE VOQUEZNA TRIPLE PAK PHATHOM N215152 May 3, 2022 RX CAPSULE, TABLET, TABLET ORAL May 3, 2032 GENERATING ANTIBIOTIC INCENTIVES NOW
500MG;EQ 20MG BASE VOQUEZNA DUAL PAK PHATHOM N215153 May 3, 2022 RX CAPSULE, TABLET ORAL May 3, 2032 GENERATING ANTIBIOTIC INCENTIVES NOW

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
5-hydroxytryptamine receptor 2A GPCR IC50 6.22 WOMBAT-PK
5-hydroxytryptamine receptor 2B GPCR IC50 5.96 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
4017605 VUID
N0000145985 NUI
D00229 KEGG_DRUG
34642-77-8 SECONDARY_CAS_RN
1297882 RXNORM
C0002645 UMLSCUI
CHEBI:2676 CHEBI
CHEMBL1082 ChEMBL_ID
DB01060 DRUGBANK_ID
CHEMBL2105950 ChEMBL_ID
D000658 MESH_DESCRIPTOR_UI
33613 PUBCHEM_CID
10895 IUPHAR_LIGAND_ID
804826J2HU UNII
11786 MMSL
3600 MMSL
4187 MMSL
d00088 MMSL
002707 NDDF
003675 NDDF
003718 NDDF
4017604 VANDF
4017605 VANDF
AXL PDB_CHEM_ID
3230 INN_ID
27658006 SNOMEDCT_US
372687004 SNOMEDCT_US
427483001 SNOMEDCT_US
785686003 SNOMEDCT_US
96068000 SNOMEDCT_US
61336-70-7 SECONDARY_CAS_RN

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Amoxicillin HUMAN PRESCRIPTION DRUG LABEL 1 0093-2263 TABLET, FILM COATED 500 mg ORAL ANDA 26 sections
Amoxicillin HUMAN PRESCRIPTION DRUG LABEL 1 0093-2263 TABLET, FILM COATED 500 mg ORAL ANDA 26 sections
Amoxicillin HUMAN PRESCRIPTION DRUG LABEL 1 0093-2264 TABLET, FILM COATED 875 mg ORAL ANDA 26 sections
Amoxicillin HUMAN PRESCRIPTION DRUG LABEL 1 0093-2264 TABLET, FILM COATED 875 mg ORAL ANDA 26 sections
Amoxicillin HUMAN PRESCRIPTION DRUG LABEL 1 0093-2267 TABLET, CHEWABLE 125 mg ORAL ANDA 26 sections
Amoxicillin HUMAN PRESCRIPTION DRUG LABEL 1 0093-2267 TABLET, CHEWABLE 125 mg ORAL ANDA 26 sections
Amoxicillin HUMAN PRESCRIPTION DRUG LABEL 1 0093-2268 TABLET, CHEWABLE 250 mg ORAL ANDA 26 sections
Amoxicillin HUMAN PRESCRIPTION DRUG LABEL 1 0093-2268 TABLET, CHEWABLE 250 mg ORAL ANDA 26 sections
Amoxicillin and Clavulanate Potassium HUMAN PRESCRIPTION DRUG LABEL 2 0093-2270 TABLET, CHEWABLE 200 mg ORAL ANDA 26 sections
Amoxicillin and Clavulanate Potassium HUMAN PRESCRIPTION DRUG LABEL 2 0093-2270 TABLET, CHEWABLE 200 mg ORAL ANDA 26 sections
Amoxicillin and Clavulanate Potassium HUMAN PRESCRIPTION DRUG LABEL 2 0093-2272 TABLET, CHEWABLE 400 mg ORAL ANDA 26 sections
Amoxicillin and Clavulanate Potassium HUMAN PRESCRIPTION DRUG LABEL 2 0093-2272 TABLET, CHEWABLE 400 mg ORAL ANDA 26 sections
Amoxicillin and Clavulanate Potassium HUMAN PRESCRIPTION DRUG LABEL 2 0093-2274 TABLET, FILM COATED 500 mg ORAL ANDA 26 sections
Amoxicillin and Clavulanate Potassium HUMAN PRESCRIPTION DRUG LABEL 2 0093-2274 TABLET, FILM COATED 500 mg ORAL ANDA 26 sections
Amoxicillin and Clavulanate Potassium HUMAN PRESCRIPTION DRUG LABEL 2 0093-2275 TABLET, FILM COATED 875 mg ORAL ANDA 26 sections
Amoxicillin and Clavulanate Potassium HUMAN PRESCRIPTION DRUG LABEL 2 0093-2275 TABLET, FILM COATED 875 mg ORAL ANDA 26 sections
Amoxicillin and Clavulanate Potassium HUMAN PRESCRIPTION DRUG LABEL 2 0093-2277 POWDER, FOR SUSPENSION 200 mg ORAL ANDA 26 sections
Amoxicillin and Clavulanate Potassium HUMAN PRESCRIPTION DRUG LABEL 2 0093-2277 POWDER, FOR SUSPENSION 200 mg ORAL ANDA 26 sections
Amoxicillin and Clavulanate Potassium HUMAN PRESCRIPTION DRUG LABEL 2 0093-2279 POWDER, FOR SUSPENSION 400 mg ORAL ANDA 26 sections
Amoxicillin and Clavulanate Potassium HUMAN PRESCRIPTION DRUG LABEL 2 0093-2279 POWDER, FOR SUSPENSION 400 mg ORAL ANDA 26 sections
Amoxicillin HUMAN PRESCRIPTION DRUG LABEL 1 0093-3107 CAPSULE 250 mg ORAL ANDA 26 sections
Amoxicillin HUMAN PRESCRIPTION DRUG LABEL 1 0093-3107 CAPSULE 250 mg ORAL ANDA 26 sections
Amoxicillin HUMAN PRESCRIPTION DRUG LABEL 1 0093-3109 CAPSULE 500 mg ORAL ANDA 26 sections
Amoxicillin HUMAN PRESCRIPTION DRUG LABEL 1 0093-3109 CAPSULE 500 mg ORAL ANDA 26 sections
Amoxicillin HUMAN PRESCRIPTION DRUG LABEL 1 0093-4150 POWDER, FOR SUSPENSION 125 mg ORAL ANDA 26 sections
Amoxicillin HUMAN PRESCRIPTION DRUG LABEL 1 0093-4155 POWDER, FOR SUSPENSION 250 mg ORAL ANDA 26 sections
Amoxicillin HUMAN PRESCRIPTION DRUG LABEL 1 0093-4155 POWDER, FOR SUSPENSION 250 mg ORAL ANDA 26 sections
Amoxicillin HUMAN PRESCRIPTION DRUG LABEL 1 0093-4160 POWDER, FOR SUSPENSION 200 mg ORAL ANDA 26 sections
Amoxicillin HUMAN PRESCRIPTION DRUG LABEL 1 0093-4160 POWDER, FOR SUSPENSION 200 mg ORAL ANDA 26 sections
Amoxicillin HUMAN PRESCRIPTION DRUG LABEL 1 0093-4161 POWDER, FOR SUSPENSION 400 mg ORAL ANDA 26 sections