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

Stem definitionDrug idCAS RN
antibacterials, nalidixic acid derivatives 659 85721-33-1

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • ciprofloxacin
  • ciprofloxacin hydrochloride
  • ciprofloxacillin
  • ciprofloxacine
  • ciprofloxacin hydrochloride monohydrate
  • ciprofloxacin HCl
  • ciprofloxacin lactate
A broad-spectrum antimicrobial carboxyfluoroquinoline.
  • Molecular weight: 331.35
  • Formula: C17H18FN3O3
  • CLOGP: -0.47
  • LIPINSKI: 0
  • HAC: 6
  • HDO: 2
  • TPSA: 72.88
  • ALOGS: -2.39
  • ROTB: 3
  • Status: OFP
    • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
1 g O
0.80 g P

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 4 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 0.15 mg/mL Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 65 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 34.49 µM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 60 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution) 2.10 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 8.30 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.70 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 3.80 hours Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
Oct. 22, 1987 FDA BAYER HLTHCARE

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 1290.66 9.34 2130 110480 248880 50243634
Tendon pain 621.18 9.34 238 112372 2740 50489774
Tendonitis 529.43 9.34 375 112235 16330 50476184
Abortion spontaneous 423.19 9.34 493 112117 41279 50451235
Drug reaction with eosinophilia and systemic symptoms 333.17 9.34 362 112248 28062 50464452
Tendon rupture 275.27 9.34 181 112429 6963 50485551
Tendon disorder 245.31 9.34 151 112459 5171 50487343
Drug interaction 243.31 9.34 983 111627 198638 50293876
Pemphigus 242.81 9.34 5 112605 120161 50372353
Toxic epidermal necrolysis 224.70 9.34 255 112355 20737 50471777
Tubulointerstitial nephritis 212.78 9.34 213 112397 14998 50477516
Pathogen resistance 204.39 9.34 138 112472 5551 50486963
Hand deformity 203.10 9.34 4 112606 100195 50392319
Glossodynia 188.92 9.34 19 112591 115550 50376964
Drug ineffective 188.79 9.34 1064 111546 818269 49674245
Rheumatoid arthritis 186.10 9.34 110 112500 202440 50290074
Synovitis 168.66 9.34 35 112575 123830 50368684
Acute kidney injury 154 9.34 950 111660 227108 50265406
Systemic lupus erythematosus 146.04 9.34 65 112545 140557 50351957
Therapeutic product effect decreased 141.11 9.34 63 112547 135987 50356527
Clostridium difficile colitis 140.32 9.34 185 112425 17557 50474957
Anti-cyclic citrullinated peptide antibody positive 138.50 9.34 4 112606 70583 50421931
Contraindicated product administered 138.03 9.34 80 112530 148878 50343636
Clostridium difficile infection 132.66 9.34 218 112392 25221 50467293
Arthropathy 127.26 9.34 99 112511 157807 50334707
Pericarditis 125.85 9.34 14 112596 78675 50413839
Stevens-Johnson syndrome 123.82 9.34 194 112416 21558 50470956
Alopecia 110.40 9.34 238 112372 244809 50247705
Tinnitus 109.30 9.34 212 112398 27920 50464594
Drug intolerance 107.94 9.34 202 112408 218902 50273612
Infusion related reaction 104.85 9.34 134 112476 169423 50323091
Wound 103.54 9.34 53 112557 105741 50386773
Dysbiosis 100.32 9.34 42 112568 618 50491896
Completed suicide 97.29 9.34 90 112520 131799 50360715
Myalgia 95.46 9.34 536 112074 123783 50368731
Rheumatoid factor positive 93.71 9.34 4 112606 49855 50442659
Joint swelling 92.63 9.34 261 112349 245025 50247489
Duodenal ulcer perforation 87.98 9.34 3 112607 45608 50446906
Death 86.57 9.34 401 112209 324978 50167536
Cholecystitis chronic 82.99 9.34 105 112505 9564 50482950
Paraesthesia 82.95 9.34 504 112106 119739 50372775
Fall 79.80 9.34 429 112181 334503 50158011
Helicobacter infection 79.07 9.34 9 112601 49693 50442821
Early retirement 78.20 9.34 16 112594 4 50492510
Tendon discomfort 78.17 9.34 24 112586 131 50492383
Hepatic enzyme increased 74.59 9.34 119 112491 137261 50355253
Panic attack 74.20 9.34 145 112465 19197 50473317
Anxiety 72.44 9.34 657 111953 176949 50315565
Rash maculo-papular 71.62 9.34 173 112437 26468 50466046
Drug resistance 71.21 9.34 141 112469 18848 50473666
Injection site pain 70.42 9.34 86 112524 110938 50381576
Disturbance in attention 69.82 9.34 189 112421 30997 50461517
Tendon injury 68.54 9.34 44 112566 1623 50490891
Multiple organ dysfunction syndrome 68.54 9.34 257 112353 50080 50442434
Treatment failure 68.51 9.34 126 112484 137511 50355003
Dermatitis exfoliative 68.24 9.34 70 112540 5072 50487442
Abdominal pain 66.68 9.34 811 111799 235417 50257097
Therapeutic product effect incomplete 65.65 9.34 64 112546 91451 50401063
Geotrichum infection 65.10 9.34 28 112582 442 50492072
Discomfort 64.56 9.34 88 112522 108292 50384222
Joint noise 63.05 9.34 57 112553 3530 50488984
Musculoskeletal injury 61.69 9.34 19 112591 105 50492409
Muscle injury 60.88 9.34 6 112604 37105 50455409
Nasopharyngitis 60.44 9.34 223 112387 192704 50299810
Neuropathy peripheral 60.14 9.34 395 112215 96362 50396152
Skin candida 59.52 9.34 37 112573 1289 50491225
Fistula 59.35 9.34 82 112528 8136 50484378
Intentional overdose 58.66 9.34 33 112577 62471 50430043
Febrile neutropenia 57.87 9.34 394 112216 97273 50395241
Folliculitis 55.65 9.34 10 112600 39215 50453299
Weight increased 55.29 9.34 246 112364 201645 50290869
Renal tubular necrosis 52.82 9.34 87 112523 10081 50482433
Pseudomembranous colitis 52.41 9.34 46 112564 2739 50489775
Burning sensation 51.41 9.34 219 112391 45227 50447287
Pyrexia 51.00 9.34 1155 111455 379048 50113466
Product use issue 50.68 9.34 167 112443 149308 50343206
Injection site erythema 49.70 9.34 56 112554 74880 50417634
Connective tissue disorder 49.41 9.34 31 112579 1098 50491416
Peripheral swelling 49.39 9.34 263 112347 205673 50286841
Swelling 48.47 9.34 256 112354 200616 50291898
Psoriatic arthropathy 48.38 9.34 22 112588 47010 50445504
Trimethylaminuria 47.56 9.34 16 112594 122 50492392
Torsade de pointes 46.95 9.34 90 112520 11745 50480769
Urinary tract infection 45.67 9.34 726 111884 223294 50269220
Anal abscess 45.65 9.34 49 112561 3742 50488772
Thrombocytopenia 45.43 9.34 459 112151 127214 50365300
Food intolerance 45.26 9.34 40 112570 2404 50490110
Abdominal discomfort 45.01 9.34 316 112294 231325 50261189
Impaired work ability 44.91 9.34 96 112514 13544 50478970
Loss of employment 44.30 9.34 33 112577 1553 50490961
Pseudomonas infection 44.10 9.34 77 112533 9353 50483161
Device expulsion 43.94 9.34 6 112604 28816 50463698
Injury 43.69 9.34 220 112390 48705 50443809
Diarrhoea 43.51 9.34 1659 110951 586817 49905697
Emotional distress 42.95 9.34 151 112459 28512 50464002
Asthma-chronic obstructive pulmonary disease overlap syndrome 42.83 9.34 21 112589 454 50492060
Hip arthroplasty 42.64 9.34 8 112602 30421 50462093
Total lung capacity increased 42.35 9.34 24 112586 703 50491811
Maternal exposure during pregnancy 42.34 9.34 197 112413 159581 50332933
Colitis 42.29 9.34 184 112426 38345 50454169
Infective pulmonary exacerbation of cystic fibrosis 41.52 9.34 68 112542 7841 50484673
Muscle atrophy 41.12 9.34 59 112551 6062 50486452
Injection site reaction 40.73 9.34 31 112579 50001 50442513
Drug abuse 40.48 9.34 44 112566 59802 50432712
Hallucination 40.40 9.34 208 112402 46449 50446065
Product dose omission issue 40.17 9.34 242 112368 183596 50308918
Therapeutic response decreased 40.09 9.34 28 112582 47203 50445311
Nervous system disorder 40.06 9.34 102 112508 16121 50476393
Diverticulitis 39.95 9.34 163 112447 33019 50459495
Segmental diverticular colitis 39.69 9.34 14 112596 125 50492389
Anal fistula 39.45 9.34 39 112571 2703 50489811
Acute generalised exanthematous pustulosis 39.25 9.34 71 112539 8867 50483647
Pedal pulse abnormal 38.92 9.34 14 112596 133 50492381
Osteoporosis 38.90 9.34 26 112584 44853 50447661
Female genital tract fistula 38.31 9.34 44 112566 3622 50488892
Injection site swelling 37.86 9.34 23 112587 41750 50450764
Chronic kidney disease 37.76 9.34 182 112428 39589 50452925
Aspergillus infection 37.66 9.34 60 112550 6761 50485753
Nephritis allergic 37.59 9.34 14 112596 148 50492366
Off label use 37.57 9.34 788 111822 473638 50018876
Neutropenia 37.44 9.34 498 112112 147467 50345047
Pulmonary eosinophilia 37.29 9.34 15 112595 198 50492316
Pouchitis 35.82 9.34 18 112592 411 50492103
Sinusitis 34.94 9.34 229 112381 170329 50322185
Ectropion 34.37 9.34 13 112597 144 50492370
Factor V deficiency 34.27 9.34 11 112599 71 50492443
Muscle twitching 34.01 9.34 93 112517 15338 50477176
Pyelonephritis 33.70 9.34 91 112519 14898 50477616
Mitochondrial cytopathy 32.55 9.34 14 112596 221 50492293
Suicide attempt 31.81 9.34 41 112569 51691 50440823
Muscular weakness 31.61 9.34 337 112273 94676 50397838
Klebsiella infection 31.40 9.34 57 112553 7137 50485377
Toxicity to various agents 31.25 9.34 312 112298 212187 50280327
Wrong technique in product usage process 31.14 9.34 47 112563 55463 50437051
Procedural anxiety 31.11 9.34 19 112591 641 50491873
Vulvovaginal burning sensation 31.05 9.34 27 112583 1588 50490926
Ill-defined disorder 30.92 9.34 46 112564 54608 50437906
Muscle contractions involuntary 30.79 9.34 29 112581 1893 50490621
Malignant neoplasm progression 30.74 9.34 66 112544 68058 50424456
Calcium ionised decreased 30.73 9.34 14 112596 255 50492259
Mucosal inflammation 30.71 9.34 173 112437 39969 50452545
Gastroenteritis pseudomonas 30.66 9.34 6 112604 0 50492514
Abnormal palmar/plantar creases 30.65 9.34 9 112601 41 50492473
Intentional product use issue 30.35 9.34 80 112530 76838 50415676
Psoriasis 30.19 9.34 68 112542 68932 50423582
Injection site bruising 29.65 9.34 23 112587 36745 50455769
Factor V inhibition 29.46 9.34 12 112598 164 50492350
Fat tissue decreased 29.18 9.34 7 112603 11 50492503
Anorectal ulcer 29.18 9.34 9 112601 50 50492464
Cystitis 28.94 9.34 184 112426 44380 50448134
Mineral deficiency 28.81 9.34 7 112603 12 50492502
Impaired healing 28.76 9.34 71 112539 69715 50422799
Non-consummation 28.74 9.34 9 112601 53 50492461
Pregnancy 28.65 9.34 15 112595 29562 50462952
Oliguria 28.41 9.34 59 112551 8157 50484357
Coma 28.34 9.34 52 112558 56827 50435687
Linear IgA disease 28.31 9.34 23 112587 1231 50491283
Oesophageal spasm 28.22 9.34 30 112580 2266 50490248
Weight bearing difficulty 28.13 9.34 30 112580 2274 50490240
Flank pain 27.88 9.34 78 112532 13037 50479477
Megacolon 27.82 9.34 26 112584 1680 50490834
Fungaemia 27.81 9.34 28 112582 1984 50490530
Moraxella test positive 27.79 9.34 7 112603 15 50492499
Nerve injury 27.76 9.34 59 112551 8291 50484223
Abscess 27.55 9.34 82 112528 14190 50478324
Potentiating drug interaction 27.44 9.34 38 112572 3778 50488736
Biliary dyskinesia 27.32 9.34 31 112579 2519 50489995
Bacterial colitis 27.30 9.34 9 112601 64 50492450
Injection site pruritus 27.01 9.34 30 112580 40381 50452133
Pancytopenia 27.00 9.34 296 112314 83734 50408780
Knee arthroplasty 26.96 9.34 24 112586 35822 50456692
Fatigue 26.79 9.34 1295 111315 706306 49786208
Acute hepatic failure 26.49 9.34 86 112524 15591 50476923
Bladder pain 26.45 9.34 25 112585 1639 50490875
Sepsis 26.37 9.34 429 112181 132496 50360018
Acinetobacter infection 25.72 9.34 23 112587 1404 50491110
Photosensitivity reaction 25.71 9.34 75 112535 12836 50479678
Candida infection 25.55 9.34 112 112498 23411 50469103
Stomatitis 25.07 9.34 128 112482 101216 50391298
Frequent bowel movements 25.03 9.34 78 112532 13840 50478674
Accidental exposure to product 24.96 9.34 10 112600 23047 50469467
Drug-induced liver injury 24.84 9.34 126 112484 27969 50464545
Hyperacusis 24.74 9.34 25 112585 1779 50490735
Cardio-respiratory arrest 24.49 9.34 52 112558 53840 50438674
Cystic fibrosis 24.41 9.34 31 112579 2833 50489681
Idiopathic intracranial hypertension 24.22 9.34 28 112582 2321 50490193
Dermatitis bullous 24.21 9.34 51 112559 7122 50485392
Rectal tube insertion 24.10 9.34 6 112604 12 50492502
Pain 23.99 9.34 1049 111561 577854 49914660
Clostridium test positive 23.59 9.34 26 112584 2046 50490468
Condition aggravated 23.57 9.34 493 112117 296565 50195949
Septic shock 23.51 9.34 212 112398 56963 50435551
Multiple sclerosis relapse 23.50 9.34 37 112573 42927 50449587
Breast cancer 23.40 9.34 37 112573 42853 50449661
Hypercreatininaemia 23.34 9.34 13 112597 368 50492146
Phlebitis 23.31 9.34 44 112566 5676 50486838
Gastroenteritis staphylococcal 22.92 9.34 8 112602 69 50492445
Chemical burns of eye 22.72 9.34 8 112602 71 50492443
Diabetes mellitus 22.54 9.34 47 112563 48986 50443528
Osteochondrosis 22.48 9.34 19 112591 1075 50491439
Hypoaesthesia 22.44 9.34 403 112207 126854 50365660
Hepatitis cholestatic 22.42 9.34 45 112565 6072 50486442
Fixed eruption 22.42 9.34 17 112593 822 50491692
Basal cell carcinoma 22.39 9.34 12 112598 23344 50469170
Renal injury 22.16 9.34 55 112555 8556 50483958
Tendon necrosis 22.10 9.34 5 112605 5 50492509
Feeding intolerance 22.09 9.34 14 112596 505 50492009
Diaphragmatic rupture 22.02 9.34 11 112599 248 50492266
Rotator cuff syndrome 21.97 9.34 66 112544 11478 50481036
Femur fracture 21.71 9.34 31 112579 37433 50455081
Bone marrow granuloma 21.68 9.34 6 112604 21 50492493
Injection site hyperaesthesia 21.57 9.34 7 112603 47 50492467
Rectal abscess 21.21 9.34 18 112592 1024 50491490
Hallucinations, mixed 21.17 9.34 35 112575 4068 50488446
Hypersensitivity 21.14 9.34 344 112266 214817 50277697
Product contamination microbial 21.10 9.34 10 112600 200 50492314
Depersonalisation/derealisation disorder 20.98 9.34 19 112591 1179 50491335
Meningitis candida 20.97 9.34 7 112603 52 50492462
Restlessness 20.94 9.34 111 112499 25062 50467452
Polyneuropathy 20.91 9.34 67 112543 12064 50480450
Injection site warmth 20.87 9.34 3 112607 13863 50478651
Cholestatic liver injury 20.69 9.34 24 112586 1997 50490517
Confabulation 20.63 9.34 11 112599 285 50492229
Bacteriuria 20.51 9.34 15 112595 686 50491828
Leukocytosis 20.48 9.34 102 112508 22477 50470037
Tendon laxity 20.44 9.34 4 112606 0 50492514
Neurotransmitter level altered 20.44 9.34 4 112606 0 50492514
Renal vein compression 20.44 9.34 4 112606 0 50492514
Limb immobilisation 20.32 9.34 6 112604 28 50492486
Palpitations 20.25 9.34 309 112301 94197 50398317
Myopathy 20.06 9.34 55 112555 9084 50483430
Gastrointestinal scarring 19.99 9.34 10 112600 226 50492288
Neutropenic sepsis 19.89 9.34 73 112537 14074 50478440
Infrequent bowel movements 19.84 9.34 18 112592 1120 50491394
Muscle tightness 19.78 9.34 59 112551 10221 50482293
Live birth 19.68 9.34 6 112604 16402 50476112
Product deposit 19.65 9.34 9 112601 166 50492348
Tonsillar haemorrhage 19.56 9.34 10 112600 237 50492277
Abdominal pain lower 19.53 9.34 98 112512 21658 50470856
Head injury 19.40 9.34 15 112595 24005 50468509
Type 2 diabetes mellitus 19.38 9.34 29 112581 34346 50458168
Vitreous floaters 19.37 9.34 39 112571 5275 50487239
Medical device site pain 19.36 9.34 9 112601 172 50492342
Asthma 19.28 9.34 118 112492 89219 50403295
Exercise tolerance decreased 19.25 9.34 37 112573 4837 50487677
Nasal polyps 19.22 9.34 26 112584 2528 50489986
Blood cholesterol increased 19.17 9.34 61 112549 55154 50437360
Neutrophilic dermatosis 19.15 9.34 8 112602 117 50492397
Skin oedema 19.07 9.34 15 112595 766 50491748
Product administration error 19.06 9.34 10 112600 19689 50472825
Long QT syndrome 19.06 9.34 28 112582 2939 50489575
Vulvovaginal swelling 19.05 9.34 12 112598 428 50492086
Cytokine release syndrome 18.99 9.34 52 112558 8582 50483932
Cholelithiasis 18.91 9.34 147 112463 37826 50454688
Visual snow syndrome 18.91 9.34 5 112605 14 50492500
Herpes zoster 18.89 9.34 87 112523 70699 50421815
COVID-19 18.81 9.34 48 112562 46614 50445900
Oesophageal pain 18.81 9.34 27 112583 2775 50489739
Enterococcal infection 18.75 9.34 45 112565 6853 50485661
Activated partial thromboplastin time prolonged 18.75 9.34 43 112567 6359 50486155
Diabetic macroangiopathy 18.73 9.34 8 112602 124 50492390
Arrhythmia 18.62 9.34 132 112478 33000 50459514
Acute febrile neutrophilic dermatosis 18.54 9.34 26 112584 2616 50489898
Escherichia infection 18.47 9.34 60 112550 10881 50481633
Roseola 18.21 9.34 4 112606 3 50492511
Eosinophilia 18.17 9.34 86 112524 18566 50473948
Pulmonary pain 18.08 9.34 24 112586 2291 50490223
Haematoma 18.00 9.34 123 112487 30387 50462127
Hypotony of eye 17.96 9.34 8 112602 138 50492376
Hepatitis infectious mononucleosis 17.93 9.34 7 112603 85 50492429
Sphingomonas paucimobilis infection 17.81 9.34 6 112604 46 50492468
Gallbladder rupture 17.80 9.34 11 112599 379 50492135
Anhedonia 17.70 9.34 54 112556 9470 50483044
Extremity necrosis 17.69 9.34 19 112591 1452 50491062
Sensory processing disorder 17.68 9.34 4 112606 4 50492510
Enterovesical fistula 17.61 9.34 12 112598 490 50492024
May-Thurner syndrome 17.55 9.34 5 112605 20 50492494
Toxic skin eruption 17.48 9.34 60 112550 11191 50481323
Blood creatinine increased 17.48 9.34 252 112358 75908 50416606
Intentional product misuse 17.39 9.34 50 112560 46684 50445830
Grip strength decreased 17.39 9.34 3 112607 12118 50480396
Myoclonus 17.35 9.34 71 112539 14399 50478115
Visual impairment 17.33 9.34 230 112380 68045 50424469
Faecal volume decreased 17.25 9.34 8 112602 152 50492362
Vanishing bile duct syndrome 17.23 9.34 13 112597 624 50491890
Product substitution issue 17.12 9.34 5 112605 14052 50478462
Gastrointestinal infection 16.97 9.34 44 112566 7030 50485484
Bladder trabeculation 16.97 9.34 6 112604 54 50492460
Cholecystitis acute 16.85 9.34 44 112566 7062 50485452
Seroconversion test positive 16.82 9.34 5 112605 24 50492490
Anal fissure 16.71 9.34 27 112583 3078 50489436
Skin injury 16.63 9.34 19 112591 1555 50490959
Excessive eye blinking 16.56 9.34 15 112595 931 50491583
Vaginal flatulence 16.54 9.34 9 112601 243 50492271
Recall phenomenon 16.50 9.34 12 112598 544 50491970
Product quality issue 16.47 9.34 27 112583 30831 50461683
Small fibre neuropathy 16.40 9.34 8 112602 171 50492343
Musculoskeletal stiffness 16.32 9.34 195 112415 128286 50364228
Erythema 16.30 9.34 434 112176 145980 50346534
Intrauterine infection 16.30 9.34 7 112603 110 50492404
Eczema asteatotic 16.12 9.34 9 112601 256 50492258
Headache 16.09 9.34 943 111667 505592 49986922
Pulmonary arterial hypertension 16.02 9.34 13 112597 20306 50472208
Hypertension 16.01 9.34 353 112257 210850 50281664
Neuralgia 15.92 9.34 93 112517 21770 50470744
Haemorrhagic vasculitis 15.82 9.34 6 112604 67 50492447
Escherichia urinary tract infection 15.77 9.34 55 112555 10340 50482174
Henoch-Schonlein purpura 15.75 9.34 15 112595 993 50491521
Staphylococcal scalded skin syndrome 15.70 9.34 7 112603 121 50492393
Burnout syndrome 15.67 9.34 8 112602 189 50492325
Foot deformity 15.51 9.34 12 112598 19198 50473316
Nerve degeneration 15.51 9.34 6 112604 71 50492443
Toxic neuropathy 15.50 9.34 10 112600 372 50492142
Hyperchlorhydria 15.40 9.34 18 112592 1510 50491004
Nephropathy toxic 15.37 9.34 46 112564 7983 50484531
Vomiting 15.37 9.34 1207 111403 459551 50032963
Injection site streaking 15.36 9.34 5 112605 34 50492480
Injection site joint erythema 15.33 9.34 3 112607 0 50492514
Chills 15.25 9.34 301 112309 96386 50396128
Rhabdomyolysis 15.18 9.34 143 112467 38884 50453630
Tongue geographic 15.14 9.34 6 112604 76 50492438
Infective aneurysm 15.10 9.34 10 112600 389 50492125
Purple glove syndrome 15.08 9.34 8 112602 205 50492309
Norovirus test positive 14.96 9.34 7 112603 136 50492378
Sensory disturbance 14.95 9.34 59 112551 11770 50480744
Bulimia nervosa 14.92 9.34 10 112600 397 50492117
Deficiency of bile secretion 14.92 9.34 4 112606 12 50492502
Abdominal pain upper 14.91 9.34 462 112148 158847 50333667
Haemolytic anaemia 14.83 9.34 50 112560 9242 50483272
Red blood cell sedimentation rate abnormal 14.80 9.34 9 112601 16334 50476180
Mouth ulceration 14.80 9.34 110 112500 27914 50464600
Neutropenic infection 14.79 9.34 15 112595 1072 50491442
Skin test positive 14.76 9.34 12 112598 643 50491871
Ballismus 14.73 9.34 6 112604 82 50492432
Thermal burn 14.72 9.34 33 112577 4808 50487706
Fistula discharge 14.71 9.34 14 112596 926 50491588
Paraesthesia oral 14.68 9.34 60 112550 12161 50480353
Incorrect route of product administration 14.64 9.34 12 112598 18654 50473860
Burning mouth syndrome 14.57 9.34 10 112600 413 50492101
Lividity 14.57 9.34 8 112602 220 50492294
Intentional self-injury 14.54 9.34 18 112592 23094 50469420
Vulvovaginal pain 14.44 9.34 21 112589 2184 50490330
Crystal nephropathy 14.42 9.34 13 112597 802 50491712
Cerebrovascular accident 14.32 9.34 138 112472 94542 50397972
Walking disability 14.30 9.34 16 112594 1280 50491234
Histamine intolerance 14.24 9.34 5 112605 44 50492470
Flushing 14.20 9.34 89 112521 66926 50425588
Infusion site streaking 14.14 9.34 10 112600 434 50492080
Poisoning 14.11 9.34 5 112605 12424 50480090
Respiratory tract oedema 14.05 9.34 10 112600 438 50492076
Acid base balance abnormal 13.97 9.34 8 112602 239 50492275
Tuberculosis gastrointestinal 13.95 9.34 9 112601 335 50492179
Haematuria 13.79 9.34 101 112509 25512 50467002
Depressed level of consciousness 13.78 9.34 64 112546 51889 50440625
Osteonecrosis 13.68 9.34 18 112592 22499 50470015
Bacteraemia 13.66 9.34 66 112544 14367 50478147
Foetal exposure during pregnancy 13.64 9.34 25 112585 27334 50465180
Muscle rupture 13.59 9.34 20 112590 2102 50490412
Cholestasis 13.58 9.34 100 112510 25301 50467213
Chronic fatigue syndrome 13.57 9.34 14 112596 1021 50491493
Spinal fracture 13.52 9.34 9 112601 15564 50476950
Acute myocardial infarction 13.51 9.34 28 112582 29245 50463269
Hyperpathia 13.49 9.34 4 112606 19 50492495
Dysuria 13.45 9.34 109 112501 28395 50464119
Malignant melanoma 13.45 9.34 3 112607 10105 50482409
Therapy non-responder 13.44 9.34 63 112547 50959 50441555
Clostridium colitis 13.44 9.34 18 112592 1734 50490780
Encephalopathy 13.35 9.34 124 112486 33587 50458927
Fear of death 13.32 9.34 13 112597 887 50491627
Genital paraesthesia 13.32 9.34 4 112606 20 50492494
Anal paraesthesia 13.32 9.34 4 112606 20 50492494
Portal fibrosis 13.31 9.34 8 112602 262 50492252
Deafness bilateral 13.30 9.34 15 112595 1211 50491303
Abdominal tenderness 13.27 9.34 41 112569 7239 50485275
Somatic dysfunction 13.26 9.34 3 112607 3 50492511
Cross sensitivity reaction 13.26 9.34 19 112591 1950 50490564
Iatrogenic injury 13.08 9.34 12 112598 757 50491757
Skin burning sensation 13.03 9.34 51 112559 10134 50482380
Fasciitis 13.02 9.34 10 112600 493 50492021
Eye swelling 12.97 9.34 83 112527 20061 50472453
Diarrhoea infectious 12.94 9.34 13 112597 919 50491595
Metastases to kidney 12.93 9.34 7 112603 187 50492327
Macular degeneration 12.93 9.34 8 112602 14380 50478134
Toxic encephalopathy 12.92 9.34 34 112576 5481 50487033
Factor XIII Inhibition 12.85 9.34 4 112606 23 50492491
Device malfunction 12.78 9.34 9 112601 15112 50477402
Adverse event 12.77 9.34 52 112558 43711 50448803
Lymphoedema 12.76 9.34 47 112563 9075 50483439
Mobility decreased 12.75 9.34 115 112495 79833 50412681
Dermatitis exfoliative generalised 12.68 9.34 24 112586 3102 50489412
Peripheral nerve injury 12.67 9.34 9 112601 393 50492121
Ligament disorder 12.63 9.34 9 112601 395 50492119
Staphylococcal infection 12.62 9.34 128 112482 35488 50457026
Rhinitis allergic 12.62 9.34 40 112570 7160 50485354
Enterocolonic fistula 12.57 9.34 4 112606 25 50492489
Type IV hypersensitivity reaction 12.57 9.34 21 112589 2461 50490053
Hot flush 12.56 9.34 53 112557 44116 50448398
Contusion 12.50 9.34 175 112435 112008 50380506
Vulvovaginal pruritus 12.48 9.34 21 112589 2475 50490039
Electrolyte imbalance 12.48 9.34 73 112537 17096 50475418
Arthritis 12.45 9.34 128 112482 86593 50405921
Bradycardia 12.43 9.34 88 112522 64338 50428176
Face oedema 12.42 9.34 75 112535 17764 50474750
Inappropriate antidiuretic hormone secretion 12.37 9.34 60 112550 13083 50479431
Road traffic accident 12.36 9.34 22 112588 24330 50468184
Immune effector cell-associated neurotoxicity syndrome 12.35 9.34 14 112596 1136 50491378
Exfoliative rash 12.28 9.34 21 112589 2509 50490005
Fungal infection 12.26 9.34 111 112499 29854 50462660
Pulmonary hypertension 12.25 9.34 36 112574 33381 50459133
Quadriparesis 12.21 9.34 17 112593 1699 50490815
Bronchitis 12.14 9.34 161 112449 103998 50388516
Blood glucose increased 12.08 9.34 101 112509 71223 50421291
Enterocutaneous fistula 12.02 9.34 14 112596 1170 50491344
Dysaesthesia 11.97 9.34 26 112584 3709 50488805
Calculus bladder 11.93 9.34 10 112600 559 50491955
Increased bronchial secretion 11.90 9.34 16 112594 1546 50490968
Transmission of an infectious agent via product 11.90 9.34 6 112604 138 50492376
Thyroxine increased 11.89 9.34 10 112600 562 50491952
Feeling jittery 11.82 9.34 5 112605 11155 50481359
Neoplasm progression 11.75 9.34 30 112580 29127 50463387
Persistent corneal epithelial defect 11.73 9.34 3 112607 7 50492507
Mitochondrial enzyme deficiency 11.72 9.34 4 112606 32 50492482
Leukocyturia 11.72 9.34 13 112597 1030 50491484
Ligament rupture 11.66 9.34 21 112589 2613 50489901
Urethral pain 11.54 9.34 8 112602 336 50492178
Acute psychosis 11.54 9.34 19 112591 2201 50490313
Thrombotic thrombocytopenic purpura 11.54 9.34 25 112585 3560 50488954
Foreign body aspiration 11.52 9.34 6 112604 148 50492366
Lower respiratory tract infection 11.52 9.34 146 112464 95055 50397459
Tremor 11.50 9.34 336 112274 114567 50377947
Peritoneal adhesions 11.49 9.34 7 112603 235 50492279
Incorrect dose administered 11.49 9.34 62 112548 48352 50444162
Vulvovaginal candidiasis 11.33 9.34 21 112589 2671 50489843
Single functional kidney 11.30 9.34 6 112604 154 50492360
Myositis 11.24 9.34 41 112569 7879 50484635
Hypertensive heart disease 11.22 9.34 19 112591 2251 50490263
Bronchiectasis 11.20 9.34 49 112561 10234 50482280
Symmetrical drug-related intertriginous and flexural exanthema 11.17 9.34 8 112602 354 50492160
Proteus test positive 11.16 9.34 6 112604 158 50492356
Conjunctival hyperaemia 11.06 9.34 18 112592 2064 50490450
Toxic shock syndrome 11.06 9.34 9 112601 483 50492031
Human ehrlichiosis 11.03 9.34 6 112604 162 50492352
Gallbladder injury 11.02 9.34 14 112596 1280 50491234
Gastrointestinal disorder 11.01 9.34 146 112464 94310 50398204
Sense of oppression 11.00 9.34 12 112598 933 50491581
Mineral metabolism disorder 10.95 9.34 3 112607 10 50492504
Levator syndrome 10.95 9.34 3 112607 10 50492504
Influenza 10.95 9.34 137 112473 89401 50403113
Somnolence 10.90 9.34 262 112348 154723 50337791
Skin warm 10.90 9.34 29 112581 4706 50487808
Toxic leukoencephalopathy 10.87 9.34 10 112600 633 50491881
Ureteric injury 10.85 9.34 4 112606 41 50492473
Epicondylitis 10.82 9.34 17 112593 1892 50490622
C-reactive protein decreased 10.78 9.34 11 112599 792 50491722
Cardiovascular disorder 10.77 9.34 49 112561 10405 50482109
Tubulointerstitial nephritis and uveitis syndrome 10.77 9.34 6 112604 170 50492344
Scar excision 10.77 9.34 4 112606 42 50492472
Plasmapheresis 10.74 9.34 7 112603 265 50492249
Cardiac failure congestive 10.74 9.34 128 112482 84254 50408260
Injection site thrombosis 10.74 9.34 5 112605 96 50492418
Choriocarcinoma 10.68 9.34 4 112606 43 50492471
Blood disorder 10.63 9.34 32 112578 5573 50486941
Tachypnoea 10.61 9.34 62 112548 14515 50477999
Osteonecrosis of jaw 10.56 9.34 37 112573 32489 50460025
Hepatic encephalopathy 10.56 9.34 46 112564 9590 50482924
Irritable bowel syndrome 10.55 9.34 69 112541 51372 50441142
Aural polyp 10.55 9.34 5 112605 100 50492414
Erythema multiforme 10.53 9.34 44 112566 9006 50483508
Panic reaction 10.49 9.34 24 112586 3545 50488969
Electrocardiogram QT prolonged 10.48 9.34 168 112442 51718 50440796
Hyperinsulinaemia 10.46 9.34 5 112605 102 50492412
Paraneoplastic syndrome 10.43 9.34 9 112601 524 50491990
Right ventricular failure 10.40 9.34 12 112598 15881 50476633
Papule 10.40 9.34 27 112583 4318 50488196
Collagen disorder 10.37 9.34 6 112604 183 50492331
Leuconostoc infection 10.34 9.34 3 112607 13 50492501
Clostridium bacteraemia 10.31 9.34 6 112604 185 50492329
Refractory anaemia with an excess of blasts 10.30 9.34 8 112602 401 50492113
Proteus infection 10.29 9.34 11 112599 836 50491678
Complex regional pain syndrome 10.28 9.34 17 112593 1976 50490538
Full blood count abnormal 10.27 9.34 23 112587 23365 50469149
Pneumonia aspiration 10.25 9.34 35 112575 30969 50461545
Hypoglossal nerve paresis 10.24 9.34 5 112605 107 50492407
Cardiac arrest 10.23 9.34 128 112482 83523 50408991
Increased tendency to bruise 10.22 9.34 4 112606 9352 50483162
Pulmonary function test decreased 10.19 9.34 23 112587 3365 50489149
Gallbladder disorder 10.18 9.34 68 112542 16674 50475840
Bone density decreased 10.17 9.34 6 112604 11069 50481445
Biopsy colon abnormal 10.16 9.34 5 112605 109 50492405
Post viral fatigue syndrome 10.08 9.34 7 112603 295 50492219
Lower respiratory tract infection bacterial 10.03 9.34 7 112603 297 50492217
Haematochezia 9.97 9.34 134 112476 39748 50452766
Abnormal faeces 9.97 9.34 26 112584 4170 50488344
Drug withdrawal syndrome 9.96 9.34 26 112584 25055 50467459
Blood pressure increased 9.94 9.34 223 112387 132909 50359605
Bovine tuberculosis 9.93 9.34 4 112606 53 50492461
Thrombocytosis 9.92 9.34 29 112581 4967 50487547
Renal failure 9.91 9.34 309 112301 106324 50386190
Drug dependence 9.90 9.34 18 112592 19741 50472773
Corneal deposits 9.86 9.34 6 112604 201 50492313
Large intestinal obstruction 9.84 9.34 16 112594 1833 50490681
Respiratory arrest 9.83 9.34 34 112576 29975 50462539
Liver function test increased 9.82 9.34 27 112583 25579 50466935
Loss of personal independence in daily activities 9.80 9.34 104 112506 69946 50422568
Injection site rash 9.76 9.34 13 112597 16164 50476350
Purpura fulminans 9.73 9.34 4 112606 56 50492458
Fracture 9.68 9.34 14 112596 16819 50475695
Vein discolouration 9.68 9.34 6 112604 208 50492306
Granulomatous liver disease 9.65 9.34 10 112600 733 50491781
Neurotoxicity 9.65 9.34 61 112549 14679 50477835
Intestinal dilatation 9.64 9.34 14 112596 1454 50491060
Device related infection 9.63 9.34 79 112531 20656 50471858
Anorectal disorder 9.61 9.34 14 112596 1458 50491056
Anal skin tags 9.59 9.34 7 112603 319 50492195
Prescribed overdose 9.58 9.34 11 112599 14589 50477925
Pyuria 9.56 9.34 15 112595 1668 50490846
Endocarditis bacterial 9.56 9.34 9 112601 587 50491927
Osteoarthritis 9.54 9.34 102 112508 68504 50424010
Pre-eclampsia 9.54 9.34 3 112607 8041 50484473
Rectal tenesmus 9.53 9.34 8 112602 448 50492066
Rash erythematous 9.51 9.34 119 112491 34733 50457781
Vulvovaginal inflammation 9.48 9.34 9 112601 593 50491921
Diarrhoea haemorrhagic 9.47 9.34 38 112572 7637 50484877
Vascular fragility 9.47 9.34 5 112605 127 50492387
Retinal detachment 9.46 9.34 29 112581 5100 50487414
Drug level decreased 9.43 9.34 34 112576 6499 50486015
Sciatica 9.41 9.34 21 112589 21361 50471153
Injection site urticaria 9.40 9.34 8 112602 12209 50480305
Therapeutic response unexpected 9.39 9.34 13 112597 15902 50476612
Oxygen saturation decreased 9.36 9.34 111 112499 73137 50419377
Proctitis 9.35 9.34 16 112594 1912 50490602
Hormone level abnormal 9.34 9.34 17 112593 2132 50490382

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
Tendon pain 706.51 10.29 267 84516 2233 29487511
Tendonitis 572.25 10.29 329 84454 7632 29482112
Tendon rupture 420.24 10.29 248 84535 6047 29483697
Tendon disorder 252.19 10.29 129 84654 2349 29487395
Pathogen resistance 213.73 10.29 181 84602 7935 29481809
Death 206.39 10.29 420 84363 341664 29148080
Tendon discomfort 176.45 10.29 53 84730 194 29489550
Toxic epidermal necrolysis 165.51 10.29 231 84552 17922 29471822
Drug abuse 153.40 10.29 23 84760 79860 29409884
Drug hypersensitivity 151.68 10.29 486 84297 67920 29421824
Completed suicide 146.21 10.29 39 84744 90207 29399537
Drug reaction with eosinophilia and systemic symptoms 122.57 10.29 257 84526 27735 29462009
Drug interaction 121.80 10.29 974 83809 196411 29293333
Myocardial infarction 114.67 10.29 89 84694 110207 29379537
Joint noise 113.90 10.29 47 84736 506 29489238
Clostridium difficile colitis 111.40 10.29 162 84621 13050 29476694
Drug resistance 100.46 10.29 203 84580 21337 29468407
Tinnitus 96.41 10.29 166 84617 15448 29474296
Choroiditis 96.39 10.29 50 84733 938 29488806
Myalgia 92.65 10.29 439 84344 73580 29416164
Tubulointerstitial nephritis 86.75 10.29 170 84613 17473 29472271
Paraesthesia 82.26 10.29 339 84444 53506 29436238
Product dose omission issue 82.24 10.29 93 84690 96290 29393454
Eye pain 79.23 10.29 129 84654 11466 29478278
Fall 72.18 10.29 263 84520 176915 29312829
Neuralgia 71.63 10.29 119 84664 10755 29478989
Septic shock 71.08 10.29 361 84422 62199 29427545
Hyperacusis 70.44 10.29 37 84746 713 29489031
Intentional overdose 69.69 10.29 13 84770 38515 29451229
Night sweats 67.57 10.29 139 84644 14793 29474951
Toxicity to various agents 66.70 10.29 264 84519 173397 29316347
Overdose 64.88 10.29 80 84703 79739 29410005
Solar lentigo 64.68 10.29 29 84754 388 29489356
Muscle twitching 64.17 10.29 96 84687 7930 29481814
Cerebrovascular accident 63.66 10.29 76 84707 76835 29412909
Panic attack 61.51 10.29 96 84687 8230 29481514
Torsade de pointes 61.04 10.29 85 84698 6576 29483168
Stevens-Johnson syndrome 58.20 10.29 139 84644 16358 29473386
Arthralgia 58.19 10.29 634 84149 138983 29350761
Dysplastic naevus 57.64 10.29 27 84756 402 29489342
Pruritus genital 57.53 10.29 29 84754 511 29489233
Dysbiosis 56.43 10.29 26 84757 372 29489372
Trichoglossia 55.94 10.29 18 84765 87 29489657
Photodermatosis 55.90 10.29 27 84756 432 29489312
Hyperfibrinolysis 54.68 10.29 13 84770 12 29489732
Foetal exposure during pregnancy 54.12 10.29 15 84768 33852 29455892
Muscle rupture 53.52 10.29 45 84738 1952 29487792
Intraocular pressure increased 51.38 10.29 66 84717 4723 29485021
Pseudomembranous colitis 50.79 10.29 49 84734 2548 29487196
Candida infection 50.21 10.29 125 84658 15100 29474644
Cardiac failure congestive 49.38 10.29 90 84693 76491 29413253
Fistula 47.72 10.29 66 84717 5073 29484671
Clostridium difficile infection 46.53 10.29 126 84657 16015 29473729
Wrong technique in product usage process 46.48 10.29 16 84767 31412 29458332
Pyrexia 45.92 10.29 1113 83670 286509 29203235
Ependymoma 45.35 10.29 11 84772 12 29489732
Abdominal abscess 44.68 10.29 55 84728 3769 29485975
Ligament pain 44.01 10.29 11 84772 15 29489729
Spinal muscular atrophy 41.48 10.29 19 84764 268 29489476
Rash morbilliform 41.32 10.29 43 84740 2450 29487294
Condition aggravated 40.44 10.29 616 84167 145679 29344065
Impaired work ability 40.23 10.29 64 84719 5576 29484168
Factor V inhibition 40.08 10.29 16 84767 157 29489587
Pseudomonas infection 39.97 10.29 93 84690 10759 29478985
Acute myocardial infarction 38.87 10.29 49 84734 48389 29441355
Rash maculo-papular 38.71 10.29 155 84628 24134 29465610
Colitis 38.08 10.29 184 84599 31064 29458680
Eosinophilia 37.40 10.29 144 84639 22017 29467727
Hyphaema 37.29 10.29 21 84762 467 29489277
Linear IgA disease 37.11 10.29 32 84751 1437 29488307
Anal fissure 37.11 10.29 43 84740 2765 29486979
Tendon injury 36.93 10.29 25 84758 778 29488966
Burning sensation 36.87 10.29 115 84668 15823 29473921
Acute generalised exanthematous pustulosis 36.63 10.29 61 84722 5522 29484222
Suicide attempt 36.07 10.29 27 84756 34083 29455661
Rheumatoid arthritis 35.91 10.29 24 84759 32128 29457616
Cutaneous vasculitis 35.00 10.29 45 84738 3223 29486521
Diastasis recti abdominis 34.57 10.29 9 84774 16 29489728
Hypertension 34.30 10.29 195 84588 116419 29373325
Blood glucose increased 33.99 10.29 74 84709 58910 29430834
Musculoskeletal injury 33.84 10.29 13 84770 114 29489630
Photosensitivity reaction 33.73 10.29 79 84704 9179 29480565
Cross sensitivity reaction 32.92 10.29 28 84755 1234 29488510
Aortic valve prolapse 32.86 10.29 8 84775 9 29489735
COVID-19 32.63 10.29 33 84750 35981 29453763
Pelvic abscess 32.25 10.29 24 84759 870 29488874
Yellow fever 31.51 10.29 7 84776 3 29489741
Sputum increased 31.51 10.29 33 84750 1894 29487850
Urosepsis 31.08 10.29 84 84699 10662 29479082
Abdominal pain 30.75 10.29 552 84231 134805 29354939
Clostridium test positive 30.66 10.29 34 84749 2083 29487661
Injection site pain 30.24 10.29 29 84754 32417 29457327
Cardiac failure 30.08 10.29 121 84662 79166 29410578
Muscle atrophy 29.95 10.29 61 84722 6445 29483299
Henoch-Schonlein purpura 29.91 10.29 27 84756 1289 29488455
Visual acuity reduced 29.62 10.29 102 84681 14774 29474970
Escherichia infection 29.47 10.29 62 84721 6702 29483042
Acute kidney injury 29.31 10.29 980 83803 264287 29225457
Undersensing 29.17 10.29 7 84776 7 29489737
Anuria 29.03 10.29 76 84707 9465 29480279
Intentional product misuse 28.93 10.29 34 84749 34627 29455117
Infective aneurysm 28.88 10.29 18 84765 485 29489259
Dyspnoea 28.88 10.29 715 84068 326017 29163727
Therapeutic product effect incomplete 28.28 10.29 43 84740 39262 29450482
Infective pulmonary exacerbation of cystic fibrosis 28.15 10.29 58 84725 6178 29483566
Sphingomonas paucimobilis infection 28.06 10.29 9 84774 43 29489701
Fixed eruption 27.99 10.29 25 84758 1177 29488567
Connective tissue disorder 27.97 10.29 13 84770 190 29489554
Chest pain 27.91 10.29 197 84586 111776 29377968
Penis injury 27.86 10.29 14 84769 245 29489499
Pain in extremity 27.83 10.29 458 84325 109975 29379769
Prostatitis 27.77 10.29 49 84734 4648 29485096
Coronary artery disease 27.53 10.29 53 84730 44137 29445607
Renal tubular necrosis 27.50 10.29 97 84686 14218 29475526
Vitreous floaters 27.37 10.29 39 84744 3082 29486662
Anxiety 27.35 10.29 369 84414 84996 29404748
Palpitations 27.02 10.29 173 84610 32431 29457313
Bradycardia 26.93 10.29 97 84686 65532 29424212
Plantar fasciitis 26.63 10.29 25 84758 1256 29488488
Rectal abscess 26.61 10.29 22 84761 932 29488812
Anal fistula 26.41 10.29 45 84738 4150 29485594
Pneumococcal sepsis 26.32 10.29 21 84762 845 29488899
Anal abscess 26.29 10.29 51 84732 5200 29484544
Motor neurone disease 26.07 10.29 15 84768 348 29489396
Penile haemorrhage 25.88 10.29 18 84765 586 29489158
Crohn's disease 25.51 10.29 37 84746 2972 29486772
Aspergillus infection 25.08 10.29 77 84706 10504 29479240
Yellow fever vaccine-associated viscerotropic disease 24.29 10.29 5 84778 0 29489744
Sensory processing disorder 24.29 10.29 5 84778 0 29489744
Malignant neoplasm progression 24.22 10.29 119 84664 73740 29416004
Pulmonary embolism 24.13 10.29 125 84658 76409 29413335
Neuropathy peripheral 23.99 10.29 310 84473 70717 29419027
Walking aid user 23.63 10.29 25 84758 1452 29488292
Premature baby 23.55 10.29 10 84773 17270 29472474
Psoriasis 23.43 10.29 35 84748 32192 29457552
Cystic fibrosis 23.42 10.29 25 84758 1467 29488277
Respiratory tract infection bacterial 23.34 10.29 17 84766 596 29489148
Pouchitis 23.34 10.29 17 84766 596 29489148
Acinetobacter infection 23.29 10.29 21 84762 1001 29488743
Enterococcal infection 23.28 10.29 64 84719 8204 29481540
Phlebitis infective 23.27 10.29 10 84773 120 29489624
Geotrichum infection 23.25 10.29 15 84768 430 29489314
Hypnagogic hallucination 23.16 10.29 8 84775 50 29489694
Hepatitis cholestatic 23.15 10.29 57 84726 6836 29482908
Uveitis 23.05 10.29 52 84731 5895 29483849
Visual impairment 23.01 10.29 155 84628 29553 29460191
Nosocomial infection 22.67 10.29 21 84762 1037 29488707
Angina pectoris 22.52 10.29 28 84755 27822 29461922
Chest injury 22.47 10.29 24 84759 1409 29488335
Diabetic ketoacidosis 22.39 10.29 9 84774 16064 29473680
Hospitalisation 22.34 10.29 63 84720 45925 29443819
Corneal deposits 22.28 10.29 11 84772 185 29489559
Ischaemic stroke 22.17 10.29 9 84774 15968 29473776
Necrotising retinitis 22.02 10.29 18 84765 750 29488994
Defaecation urgency 21.81 10.29 26 84757 1723 29488021
Lumbosacral plexus injury 21.67 10.29 6 84777 15 29489729
Weight increased 21.57 10.29 130 84653 76537 29413207
Multiple organ dysfunction syndrome 21.53 10.29 276 84507 62840 29426904
Coma 21.50 10.29 51 84732 39399 29450345
Febrile neutropenia 21.47 10.29 446 84337 111794 29377950
Sopor 21.31 10.29 3 84780 10931 29478813
Orchitis 21.22 10.29 23 84760 1373 29488371
Chronic gastrointestinal bleeding 21.06 10.29 12 84771 273 29489471
Painful respiration 20.82 10.29 21 84762 1153 29488591
Chronic obstructive pulmonary disease 20.72 10.29 55 84728 40900 29448844
Abscess intestinal 20.72 10.29 23 84760 1411 29488333
Chronic fatigue syndrome 20.68 10.29 12 84771 283 29489461
Hypoaesthesia 20.49 10.29 239 84544 53228 29436516
Megacolon 20.25 10.29 24 84759 1581 29488163
Weight bearing difficulty 20.05 10.29 18 84765 853 29488891
Cardio-respiratory arrest 19.96 10.29 76 84707 50525 29439219
Ischaemic cerebral infarction 19.72 10.29 19 84764 986 29488758
Enterocutaneous fistula 19.61 10.29 17 84766 769 29488975
Neuroleptic malignant syndrome 19.49 10.29 11 84772 16137 29473607
Abscess 19.49 10.29 67 84716 9695 29480049
Aeromonas infection 19.48 10.29 11 84772 246 29489498
Prolapse 19.43 10.29 4 84779 0 29489744
Yellow fever vaccine-associated neurotropic disease 19.43 10.29 4 84779 0 29489744
Posterior tibial tendon dysfunction 19.43 10.29 4 84779 0 29489744
Metastases to liver 19.41 10.29 5 84778 11851 29477893
Organic brain syndrome 19.32 10.29 11 84772 250 29489494
Incorrect dose administered 19.31 10.29 41 84742 32943 29456801
Anxiety disorder 19.09 10.29 23 84760 1541 29488203
Nasopharyngitis 19.06 10.29 97 84686 59568 29430176
Septic embolus 19.02 10.29 19 84764 1031 29488713
Dermatitis bullous 18.96 10.29 48 84735 5858 29483886
Product quality issue 18.94 10.29 11 84772 15884 29473860
Auditory disorder 18.89 10.29 11 84772 261 29489483
Clostridial infection 18.85 10.29 34 84749 3281 29486463
Increased viscosity of bronchial secretion 18.79 10.29 10 84773 198 29489546
Leukocytosis 18.65 10.29 114 84669 21028 29468716
Gluten sensitivity 18.65 10.29 6 84777 29 29489715
Aortic aneurysm rupture 18.61 10.29 18 84765 939 29488805
Gastrointestinal inflammation 18.59 10.29 32 84751 2976 29486768
Infusion related reaction 18.58 10.29 64 84719 43822 29445922
Urinary tract infection 18.55 10.29 301 84482 72053 29417691
Oxidative stress 18.47 10.29 7 84776 59 29489685
Trichosporon infection 18.35 10.29 15 84768 625 29489119
Food intolerance 18.35 10.29 19 84764 1076 29488668
Muscle fatigue 18.35 10.29 20 84763 1202 29488542
Mucosal disorder 17.98 10.29 22 84761 1498 29488246
Deep vein thrombosis 17.95 10.29 94 84689 57305 29432439
Musculoskeletal discomfort 17.77 10.29 49 84734 6292 29483452
Systemic candida 17.74 10.29 30 84753 2750 29486994
Nail bed inflammation 17.73 10.29 9 84774 161 29489583
Impaired quality of life 17.70 10.29 29 84754 2590 29487154
Metabolic disorder 17.43 10.29 35 84748 3660 29486084
Magnesium deficiency 17.42 10.29 7 84776 70 29489674
Stoma closure 17.39 10.29 8 84775 114 29489630
Stenotrophomonas infection 17.38 10.29 23 84760 1694 29488050
Intentional self-injury 17.32 10.29 7 84776 12454 29477290
Seizure 17.27 10.29 177 84606 92946 29396798
Epistaxis 17.12 10.29 83 84700 51621 29438123
Nephritis allergic 17.08 10.29 12 84771 397 29489347
Leukocyturia 17.08 10.29 13 84770 488 29489256
Lower respiratory tract infection bacterial 16.96 10.29 11 84772 318 29489426
Muscle tightness 16.89 10.29 38 84745 4300 29485444
Therapeutic response decreased 16.86 10.29 28 84755 24683 29465061
Corneal opacity 16.80 10.29 13 84770 500 29489244
Haematospermia 16.72 10.29 11 84772 326 29489418
Asthma 16.72 10.29 46 84737 33803 29455941
Urinary tract obstruction 16.48 10.29 32 84751 3265 29486479
Obesity 16.46 10.29 4 84779 9859 29479885
Mental fatigue 16.44 10.29 7 84776 82 29489662
Sleep disorder 16.42 10.29 123 84660 24263 29465481
Rash erythematous 16.40 10.29 112 84671 21450 29468294
Diabetes mellitus 16.25 10.29 59 84724 39772 29449972
Retinitis viral 16.22 10.29 7 84776 85 29489659
Intestinal fistula 16.17 10.29 16 84767 858 29488886
Catatonia 16.14 10.29 38 84745 4430 29485314
Cough 16.05 10.29 261 84522 126466 29363278
Cardiac disorder 16.00 10.29 54 84729 37209 29452535
Cerebral infarction 15.89 10.29 29 84754 24646 29465098
Increased bronchial secretion 15.73 10.29 21 84762 1560 29488184
Pruritus 15.59 10.29 442 84341 116407 29373337
Dysuria 15.57 10.29 114 84669 22326 29467418
Product administration error 15.55 10.29 11 84772 14299 29475445
Inflammation 15.51 10.29 115 84668 22613 29467131
Crystal nephropathy 15.50 10.29 11 84772 370 29489374
Angina bullosa haemorrhagica 15.39 10.29 6 84777 55 29489689
Flushing 15.39 10.29 38 84745 28954 29460790
Somnolence 15.27 10.29 184 84599 93771 29395973
Generalised oedema 15.26 10.29 68 84715 11097 29478647
Ligament injury 15.24 10.29 10 84773 295 29489449
Vanishing bile duct syndrome 15.24 10.29 13 84770 575 29489169
Fluorosis 15.20 10.29 6 84777 57 29489687
Abscess bacterial 15.19 10.29 8 84775 155 29489589
Treatment noncompliance 15.14 10.29 29 84754 24198 29465546
Parosmia 15.11 10.29 20 84763 1474 29488270
Blood pressure increased 15.07 10.29 137 84646 73666 29416078
Accidental exposure to product 15.01 10.29 6 84777 10747 29478997
Cystitis 14.91 10.29 55 84728 8237 29481507
Injection site haemorrhage 14.80 10.29 3 84780 8383 29481361
Ligament disorder 14.78 10.29 7 84776 107 29489637
Lip erosion 14.68 10.29 12 84771 500 29489244
Eye infection fungal 14.67 10.29 10 84773 315 29489429
Gingival recession 14.66 10.29 11 84772 404 29489340
Oesophageal mucosa erythema 14.64 10.29 5 84778 30 29489714
Subacute cutaneous lupus erythematosus 14.57 10.29 15 84768 844 29488900
Nutritional condition abnormal 14.54 10.29 11 84772 409 29489335
Aortic aneurysm 14.49 10.29 45 84738 6175 29483569
Platelet count decreased 14.46 10.29 212 84571 104460 29385284
Hyperkalaemia 14.32 10.29 110 84673 61282 29428462
Toxic encephalopathy 14.30 10.29 37 84746 4575 29485169
Intestinal stenosis 14.27 10.29 22 84761 1866 29487878
Pruritus allergic 14.24 10.29 8 84775 177 29489567
Myocardial ischaemia 14.16 10.29 15 84768 16013 29473731
Cardiac arrest 14.15 10.29 167 84616 85424 29404320
Interstitial lung disease 14.14 10.29 102 84681 57616 29432128
Sitting disability 14.11 10.29 7 84776 119 29489625
Subdural haematoma 13.98 10.29 19 84764 18174 29471570
Joint stiffness 13.94 10.29 59 84724 9414 29480330
Therapeutic product ineffective for unapproved indication 13.92 10.29 4 84779 12 29489732
Renal abscess 13.85 10.29 8 84775 187 29489557
Haemorrhoids thrombosed 13.85 10.29 8 84775 187 29489557
Blood triglycerides increased 13.77 10.29 10 84773 12824 29476920
Gallbladder polyp 13.74 10.29 10 84773 350 29489394
Mucosal hyperaemia 13.68 10.29 4 84779 13 29489731
Scrotal pain 13.68 10.29 14 84769 782 29488962
Roseolovirus test positive 13.67 10.29 6 84777 76 29489668
Mucosal atrophy 13.67 10.29 6 84777 76 29489668
Peroneal nerve palsy 13.67 10.29 26 84757 2613 29487131
Thrombotic thrombocytopenic purpura 13.52 10.29 29 84754 3177 29486567
Actinic keratosis 13.46 10.29 32 84751 3754 29485990
Cervicobrachial syndrome 13.41 10.29 9 84774 276 29489468
Otorrhoea 13.40 10.29 11 84772 461 29489283
Drug ineffective for unapproved indication 13.40 10.29 78 84705 14136 29475608
Hyperthyroidism 13.40 10.29 4 84779 8604 29481140
Large intestinal stenosis 13.22 10.29 18 84765 1363 29488381
Drug dependence 13.21 10.29 25 84758 20956 29468788
Pseudopolyp 13.19 10.29 8 84775 205 29489539
Anal stenosis 13.18 10.29 7 84776 138 29489606
Bronchopulmonary aspergillosis 13.14 10.29 70 84713 12274 29477470
Aspartate aminotransferase 13.14 10.29 6 84777 84 29489660
Glomerular filtration rate decreased 13.14 10.29 8 84775 11258 29478486
Cogwheel rigidity 13.13 10.29 17 84766 1226 29488518
Proctalgia 13.11 10.29 34 84749 4211 29485533
Underdose 13.06 10.29 9 84774 11860 29477884
Faciobrachial dystonic seizure 13.04 10.29 4 84779 16 29489728
Disease complication 12.97 10.29 24 84759 2362 29487382
Epididymitis 12.95 10.29 23 84760 2192 29487552
Food allergy 12.90 10.29 15 84768 968 29488776
Pseudomonal sepsis 12.85 10.29 27 84756 2915 29486829
Post infection glomerulonephritis 12.85 10.29 4 84779 17 29489727
Sacroiliitis 12.83 10.29 16 84767 1111 29488633
Joint instability 12.83 10.29 10 84773 389 29489355
Throat tightness 12.73 10.29 47 84736 7044 29482700
Graft versus host disease 12.68 10.29 58 84725 9570 29480174
Klebsiella infection 12.60 10.29 48 84735 7301 29482443
Drug intolerance 12.59 10.29 84 84699 48295 29441449
Irritability 12.58 10.29 28 84755 22124 29467620
Necrotising fasciitis 12.57 10.29 29 84754 3336 29486408
Withdrawal syndrome 12.55 10.29 8 84775 10984 29478760
Ligament rupture 12.52 10.29 14 84769 866 29488878
Spinal meningeal cyst 12.50 10.29 3 84780 3 29489741
Vertebral artery hypoplasia 12.50 10.29 3 84780 3 29489741
Glare 12.48 10.29 6 84777 95 29489649
Blood creatine phosphokinase increased 12.46 10.29 67 84716 40577 29449167
Perirectal abscess 12.40 10.29 18 84765 1447 29488297
Pseudoporphyria 12.39 10.29 9 84774 314 29489430
Synovitis 12.33 10.29 8 84775 10882 29478862
Necrosis 12.29 10.29 37 84746 4993 29484751
Toxic skin eruption 12.27 10.29 58 84725 9699 29480045
Lymphadenectomy 12.26 10.29 8 84775 234 29489510
Idiosyncratic drug reaction 12.25 10.29 10 84773 416 29489328
Staphylococcal infection 12.24 10.29 133 84650 29107 29460637
Lung consolidation 12.23 10.29 37 84746 5006 29484738
COVID-19 pneumonia 12.21 10.29 6 84777 9516 29480228
Rash 12.21 10.29 663 84120 189156 29300588
Corynebacterium infection 12.13 10.29 10 84773 422 29489322
Skin wrinkling 12.12 10.29 9 84774 325 29489419
Fear of death 12.10 10.29 11 84772 530 29489214
Lymphocyte count decreased 12.10 10.29 23 84760 19248 29470496
Tenderness 12.04 10.29 40 84743 5687 29484057
Bacterial disease carrier 12.03 10.29 10 84773 427 29489317
Kounis syndrome 12.02 10.29 20 84763 1809 29487935
Carditis 11.99 10.29 6 84777 104 29489640
Gastrooesophageal reflux disease 11.97 10.29 48 84735 31448 29458296
Hyperglycaemia 11.96 10.29 54 84729 34233 29455511
Osteonecrosis of jaw 11.93 10.29 18 84765 16492 29473252
Expanded disability status scale score increased 11.87 10.29 8 84775 247 29489497
Pulmonary hypertension 11.86 10.29 22 84761 18586 29471158
Breast inflammation 11.86 10.29 4 84779 23 29489721
Dyspnoea exertional 11.83 10.29 59 84724 36431 29453313
Poisoning 11.79 10.29 7 84776 9986 29479758
Influenza 11.78 10.29 71 84712 41810 29447934
Psoas abscess 11.76 10.29 11 84772 550 29489194
Jaundice 11.68 10.29 132 84651 29164 29460580
Fluid retention 11.64 10.29 32 84751 23528 29466216
Retinopathy hypertensive 11.59 10.29 8 84775 257 29489487
Prothrombin time shortened 11.57 10.29 17 84766 1381 29488363
Hypotension 11.54 10.29 448 84335 193906 29295838
Herpes zoster meningoencephalitis 11.43 10.29 8 84775 263 29489481
Hepatic amoebiasis 11.42 10.29 5 84778 63 29489681
Bladder spasm 11.42 10.29 13 84770 820 29488924
Stenotrophomonas test positive 11.38 10.29 8 84775 265 29489479
Cataract subcapsular 11.37 10.29 9 84774 358 29489386
Pudendal canal syndrome 11.29 10.29 3 84780 6 29489738
Skin injury 11.29 10.29 15 84768 1109 29488635
Drain placement 11.28 10.29 5 84778 65 29489679
Bladder pain 11.25 10.29 10 84773 468 29489276
Loss of proprioception 11.22 10.29 9 84774 365 29489379
Hyperinsulinaemia 11.21 10.29 5 84778 66 29489678
Cardiogenic shock 11.11 10.29 24 84759 19166 29470578
Eye excision 11.07 10.29 4 84779 29 29489715
Stomatococcal infection 11.05 10.29 6 84777 124 29489620
Yawning 11.03 10.29 10 84773 480 29489264
Lung neoplasm malignant 11.02 10.29 15 84768 14342 29475402
Polyneuropathy 11.02 10.29 66 84717 12086 29477658
Hypersensitivity vasculitis 11.01 10.29 27 84756 3230 29486514
Ejection fraction decreased 11.00 10.29 18 84765 15960 29473784
Arteriosclerosis 10.99 10.29 8 84775 10248 29479496
Microbiology test abnormal 10.98 10.29 3 84780 7 29489737
Blood catecholamines decreased 10.98 10.29 3 84780 7 29489737
Glutathione decreased 10.98 10.29 3 84780 7 29489737
Angina unstable 10.98 10.29 9 84774 10856 29478888
Neuropsychiatric symptoms 10.96 10.29 10 84773 484 29489260
Injection site bruising 10.96 10.29 4 84779 7576 29482168
Pancreatic enzyme abnormality 10.96 10.29 4 84779 30 29489714
Lactic acidosis 10.94 10.29 47 84736 30200 29459544
Sensory disturbance 10.92 10.29 38 84745 5531 29484213
Hyperoxaluria 10.92 10.29 6 84777 127 29489617
Spontaneous haematoma 10.91 10.29 10 84773 487 29489257
Panic reaction 10.90 10.29 16 84767 1299 29488445
Hepatic infarction 10.90 10.29 7 84776 199 29489545
Resting tremor 10.87 10.29 11 84772 606 29489138
Hypothyroidism 10.87 10.29 18 84765 15888 29473856
Gynaecomastia 10.81 10.29 5 84778 8212 29481532
Alcohol intolerance 10.79 10.29 9 84774 386 29489358
Meningitis 10.74 10.29 32 84751 4293 29485451
Walking disability 10.72 10.29 12 84771 743 29489001
Fungaemia 10.70 10.29 21 84762 2160 29487584
Product use issue 10.68 10.29 207 84576 51237 29438507
Electrocardiogram QT prolonged 10.67 10.29 154 84629 35983 29453761
Hypofibrinogenaemia 10.66 10.29 17 84766 1484 29488260
Pulmonary arterial hypertension 10.66 10.29 4 84779 7445 29482299
Left ventricular hypertrophy 10.65 10.29 3 84780 6700 29483044
Oligoarthritis 10.64 10.29 5 84778 75 29489669
Purpura non-thrombocytopenic 10.64 10.29 5 84778 75 29489669
Drug level increased 10.60 10.29 91 84692 18696 29471048
Glycosylated haemoglobin increased 10.57 10.29 7 84776 9419 29480325
Groin pain 10.53 10.29 34 84749 4764 29484980
Vitreous detachment 10.51 10.29 12 84771 759 29488985
Hepato-lenticular degeneration 10.44 10.29 3 84780 9 29489735
Cholestasis 10.42 10.29 108 84675 23354 29466390
Resuscitation 10.41 10.29 15 84768 1197 29488547
Inguinal mass 10.41 10.29 5 84778 79 29489665
Haemoglobin decreased 10.39 10.29 234 84549 108141 29381603
Atrioventricular block complete 10.35 10.29 5 84778 8006 29481738
Nervous system disorder 10.34 10.29 67 84716 12607 29477137
Aortic intramural haematoma 10.32 10.29 4 84779 36 29489708
Flavobacterium infection 10.30 10.29 5 84778 81 29489663

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
Tendon pain 1103.91 9.61 432 168895 4416 64324989
Tendonitis 849.62 9.61 576 168751 19706 64309699
Drug hypersensitivity 728.00 9.61 1794 167533 236021 64093384
Tendon rupture 514.41 9.61 332 168995 10435 64318970
Drug reaction with eosinophilia and systemic symptoms 419.24 9.61 609 168718 53608 64275797
Tendon disorder 396.30 9.61 232 169095 6100 64323305
Pathogen resistance 395.97 9.61 300 169027 12243 64317162
Toxic epidermal necrolysis 351.26 9.61 460 168867 36706 64292699
Drug interaction 308.45 9.61 1810 167517 360273 63969132
Completed suicide 267.90 9.61 127 169200 224287 64105118
Tubulointerstitial nephritis 266.73 9.61 366 168961 30543 64298862
Clostridium difficile colitis 237.38 9.61 324 169003 26899 64302506
Death 210.33 9.61 613 168714 482092 63847313
Tendon discomfort 206.97 9.61 67 169260 368 64329037
Tinnitus 203.18 9.61 340 168987 33793 64295612
Clostridium difficile infection 195.28 9.61 345 168982 35818 64293587
Rheumatoid arthritis 185.48 9.61 100 169227 164194 64165211
Drug abuse 184.14 9.61 59 169268 132315 64197090
Drug resistance 179.47 9.61 327 169000 34775 64294630
Myalgia 179.26 9.61 858 168469 157759 64171646
Paraesthesia 160.26 9.61 739 168588 133783 64195622
Stevens-Johnson syndrome 157.60 9.61 305 169022 33944 64295461
Hand deformity 149.85 9.61 3 169324 62768 64266637
Synovitis 149.19 9.61 38 169289 99052 64230353
Fall 142.45 9.61 587 168740 416239 63913166
Pemphigus 133.75 9.61 6 169321 60695 64268710
Acute kidney injury 132.32 9.61 1778 167549 447462 63881943
Joint noise 131.57 9.61 90 169237 3121 64326284
Intentional overdose 128.83 9.61 38 169289 89906 64239499
Dysbiosis 127.12 9.61 57 169270 838 64328567
Anti-cyclic citrullinated peptide antibody positive 115.85 9.61 3 169324 49559 64279846
Panic attack 115.83 9.61 202 169125 20751 64308654
Rash maculo-papular 104.56 9.61 316 169011 46710 64282695
Anxiety 102.95 9.61 895 168432 201754 64127651
Torsade de pointes 102.04 9.61 172 169155 17191 64312214
Injection site pain 100.12 9.61 87 169240 111321 64218084
Toxicity to various agents 100.06 9.61 553 168774 362960 63966445
Pseudomembranous colitis 99.66 9.61 91 169236 4825 64324580
Maternal exposure during pregnancy 98.82 9.61 65 169262 95819 64233586
Infusion related reaction 98.02 9.61 176 169151 164291 64165114
Hyperacusis 95.42 9.61 61 169266 1884 64327521
Septic shock 89.97 9.61 528 168799 104909 64224496
Glossodynia 89.64 9.61 29 169298 64667 64264738
Fistula 89.38 9.61 119 169208 9642 64319763
Tendon injury 88.96 9.61 56 169271 1683 64327722
Choroiditis 87.53 9.61 47 169280 1040 64328365
Drug intolerance 86.61 9.61 232 169095 187760 64141645
Impaired work ability 84.49 9.61 147 169180 15072 64314333
Product dose omission issue 83.33 9.61 249 169078 194498 64134907
Geotrichum infection 83.32 9.61 43 169284 875 64328530
Multiple organ dysfunction syndrome 82.14 9.61 501 168826 100912 64228493
Muscle atrophy 80.35 9.61 113 169214 9645 64319760
Contraindicated product administered 80.17 9.61 99 169228 107730 64221675
Therapeutic product effect incomplete 80.15 9.61 92 169235 103390 64226015
Muscle twitching 79.94 9.61 163 169164 18835 64310570
Pyrexia 79.88 9.61 1974 167353 556670 63772735
Rheumatoid factor positive 78.49 9.61 3 169324 34935 64294470
Nasopharyngitis 77.36 9.61 260 169067 195813 64133592
Arthropathy 77.07 9.61 124 169203 120843 64208562
Pericarditis 76.65 9.61 34 169293 62482 64266923
Early retirement 74.79 9.61 16 169311 5 64329400
Duodenal ulcer perforation 74.43 9.61 4 169323 34621 64294784
Candida infection 73.51 9.61 215 169112 31204 64298201
Suicide attempt 73.35 9.61 48 169279 70959 64258446
Burning sensation 73.09 9.61 291 169036 49373 64280032
Neuropathy peripheral 70.95 9.61 540 168787 116985 64212420
Connective tissue disorder 70.60 9.61 41 169286 1061 64328344
Weight increased 70.52 9.61 304 169023 213044 64116361
Pseudomonas infection 68.91 9.61 148 169179 17735 64311670
Factor V inhibition 68.06 9.61 28 169299 329 64329076
Abdominal pain 67.29 9.61 1173 168154 311202 64018203
Photosensitivity reaction 67.29 9.61 148 169179 18025 64311380
Helicobacter infection 65.38 9.61 11 169316 38351 64291054
Wound 64.81 9.61 63 169264 76414 64252991
Neuralgia 63.99 9.61 182 169145 26002 64303403
Myocardial infarction 63.96 9.61 222 169105 165599 64163806
Linear IgA disease 63.49 9.61 55 169272 2719 64326686
Systemic lupus erythematosus 63.41 9.61 66 169261 77546 64251859
Eosinophilia 63.35 9.61 232 169095 37844 64291561
Food intolerance 62.61 9.61 55 169272 2771 64326634
Cardiac failure congestive 62.53 9.61 158 169169 130422 64198983
Eye pain 62.46 9.61 204 169123 31421 64297984
Therapeutic product effect decreased 62.14 9.61 131 169196 115220 64214185
Acute generalised exanthematous pustulosis 62.00 9.61 123 169204 13935 64315470
Wrong technique in product usage process 60.50 9.61 49 169278 64925 64264480
Coma 59.47 9.61 86 169241 87529 64241876
Injection site erythema 59.21 9.61 59 169268 70741 64258664
Clostridium test positive 58.90 9.61 63 169264 4052 64325353
Dermatitis exfoliative 56.18 9.61 99 169228 10253 64319152
Anal abscess 56.05 9.61 83 169244 7425 64321980
Dysplastic naevus 55.50 9.61 27 169300 482 64328923
Cerebrovascular accident 55.23 9.61 181 169146 137402 64192003
Colitis 54.75 9.61 301 169026 58373 64271032
Pruritus genital 54.72 9.61 34 169293 998 64328407
Disturbance in attention 54.40 9.61 233 169094 40841 64288564
Renal tubular necrosis 54.34 9.61 154 169173 21956 64307449
Hepatic enzyme increased 54.23 9.61 168 169159 129775 64199630
Aspergillus infection 53.56 9.61 127 169200 16252 64313153
Overdose 53.55 9.61 226 169101 159340 64170065
Hyperfibrinolysis 52.23 9.61 13 169314 20 64329385
Osteoporosis 51.40 9.61 23 169304 42057 64287348
Anal fistula 51.13 9.61 66 169261 5187 64324218
Injection site swelling 49.89 9.61 23 169304 41330 64288075
Cardio-respiratory arrest 49.50 9.61 116 169211 98277 64231128
Psoriatic arthropathy 49.30 9.61 26 169301 43255 64286150
Weight bearing difficulty 48.96 9.61 47 169280 2656 64326749
Injection site reaction 48.93 9.61 31 169296 46633 64282772
Solar lentigo 48.79 9.61 30 169297 864 64328541
Hepatitis cholestatic 48.45 9.61 102 169225 12053 64317352
Vitreous floaters 48.37 9.61 71 169256 6302 64323103
Febrile neutropenia 48.32 9.61 726 168601 186931 64142474
Infective pulmonary exacerbation of cystic fibrosis 48.20 9.61 100 169227 11696 64317709
Anal fissure 48.02 9.61 62 169265 4874 64324531
Fixed eruption 47.79 9.61 42 169285 2117 64327288
Cholecystitis chronic 46.80 9.61 86 169241 9201 64320204
Joint swelling 46.74 9.61 352 168975 215030 64114375
Photodermatosis 46.35 9.61 29 169298 862 64328543
Trimethylaminuria 46.23 9.61 17 169310 144 64329261
Muscle rupture 45.82 9.61 49 169278 3151 64326254
Therapeutic response decreased 45.38 9.61 42 169285 52146 64277259
Musculoskeletal injury 45.13 9.61 17 169310 155 64329250
Acute myocardial infarction 44.83 9.61 71 169256 69647 64259758
Sphingomonas paucimobilis infection 44.81 9.61 15 169312 93 64329312
Cystic fibrosis 44.68 9.61 50 169277 3384 64326021
Malignant neoplasm progression 44.26 9.61 150 169177 112721 64216684
Rectal abscess 44.25 9.61 35 169292 1522 64327883
Infective aneurysm 44.23 9.61 28 169299 850 64328555
Nephritis allergic 43.89 9.61 25 169302 623 64328782
Peripheral swelling 43.88 9.61 345 168982 208808 64120597
Megacolon 43.79 9.61 47 169280 3035 64326370
Skin candida 43.57 9.61 36 169291 1667 64327738
Intentional product misuse 43.37 9.61 77 169250 72218 64257187
Alopecia 43.36 9.61 256 169071 165434 64163971
Psoriasis 43.35 9.61 76 169251 71627 64257778
Hypertension 42.14 9.61 456 168871 258805 64070600
Escherichia infection 41.61 9.61 110 169217 15058 64314347
COVID-19 41.26 9.61 67 169260 65073 64264332
Bradycardia 41.18 9.61 165 169162 118054 64211351
Henoch-Schonlein purpura 41.18 9.61 39 169288 2167 64327238
Exposure during pregnancy 41.17 9.61 89 169238 77586 64251819
Enterococcal infection 40.55 9.61 103 169224 13763 64315642
Asthma 40.52 9.61 122 169205 95103 64234302
Cross sensitivity reaction 40.38 9.61 47 169280 3320 64326085
Rash morbilliform 40.07 9.61 58 169269 5083 64324322
Injection site bruising 39.76 9.61 23 169304 36350 64293055
Sinusitis 39.51 9.61 223 169104 145705 64183700
Spinal muscular atrophy 39.46 9.61 18 169309 276 64329129
Sensory processing disorder 39.35 9.61 9 169318 7 64329398
Dermatitis bullous 38.91 9.61 93 169234 11961 64317444
Leukocytosis 38.89 9.61 199 169128 37541 64291864
Accidental exposure to product 37.99 9.61 11 169316 26353 64303052
Penis injury 37.52 9.61 14 169313 124 64329281
Segmental diverticular colitis 37.43 9.61 14 169313 125 64329280
Product administration error 37.23 9.61 13 169314 27630 64301775
Palpitations 36.34 9.61 427 168900 104061 64225344
Trichoglossia 36.23 9.61 18 169309 337 64329068
Acinetobacter infection 36.21 9.61 38 169289 2391 64327014
Device expulsion 36.15 9.61 6 169321 21130 64308275
Hypoaesthesia 36.11 9.61 539 168788 138569 64190836
Pouchitis 35.92 9.61 24 169303 800 64328605
Osteonecrosis of jaw 35.88 9.61 31 169296 39794 64289611
Pedal pulse abnormal 35.60 9.61 14 169313 145 64329260
Ligament pain 35.60 9.61 15 169312 188 64329217
Muscle contractions involuntary 35.43 9.61 43 169284 3174 64326231
Drug ineffective 35.01 9.61 1827 167500 838420 63490985
Plantar fasciitis 34.89 9.61 40 169287 2780 64326625
Discomfort 34.85 9.61 103 169224 80775 64248630
Abnormal palmar/plantar creases 34.62 9.61 7 169320 0 64329405
Nervous system disorder 34.57 9.61 136 169191 22942 64306463
Visual impairment 34.39 9.61 321 169006 73756 64255649
Folliculitis 34.36 9.61 18 169309 30059 64299346
Thrombocytopenia 34.30 9.61 799 168528 223002 64106403
Total lung capacity increased 34.23 9.61 22 169305 686 64328719
Diastasis recti abdominis 34.03 9.61 9 169318 20 64329385
Hyphaema 33.27 9.61 21 169306 634 64328771
Injury 33.05 9.61 256 169071 55736 64273669
Product substitution issue 33.05 9.61 4 169323 17857 64311548
Loss of employment 32.37 9.61 32 169295 1875 64327530
Pulmonary arterial hypertension 32.37 9.61 13 169314 25354 64304051
Aortic valve prolapse 32.26 9.61 8 169319 12 64329393
Drug-induced liver injury 32.22 9.61 225 169102 47418 64281987
Yellow fever 32.13 9.61 7 169320 3 64329402
Muscle tightness 31.91 9.61 82 169245 11033 64318372
Emotional distress 31.71 9.61 182 169145 35856 64293549
Intraocular pressure increased 31.17 9.61 68 169259 8234 64321171
Hallucination 31.12 9.61 310 169017 72478 64256927
Stomatitis 31.03 9.61 165 169162 109440 64219965
Diarrhoea 30.95 9.61 2248 167079 720456 63608949
Factor V deficiency 30.79 9.61 11 169316 85 64329320
Abscess 30.75 9.61 116 169211 19188 64310217
Vanishing bile duct syndrome 30.61 9.61 26 169301 1251 64328154
Bladder pain 30.44 9.61 30 169297 1751 64327654
Nerve injury 30.06 9.61 64 169263 7621 64321784
Chronic fatigue syndrome 30.03 9.61 25 169302 1170 64328235
Neutropenia 29.81 9.61 832 168495 238792 64090613
Undersensing 29.78 9.61 7 169320 7 64329398
Polyneuropathy 29.61 9.61 117 169210 19777 64309628
Red blood cell sedimentation rate abnormal 29.33 9.61 4 169323 16302 64313103
Klebsiella infection 29.28 9.61 89 169238 13192 64316213
Treatment failure 29.24 9.61 183 169144 116633 64212772
Sepsis 29.00 9.61 801 168526 229540 64099865
Off label use 28.81 9.61 1363 167964 631443 63697962
Haematospermia 28.77 9.61 14 169313 250 64329155
Depressed level of consciousness 28.77 9.61 113 169214 81323 64248082
Dysuria 28.66 9.61 199 169128 41858 64287547
Procedural anxiety 28.53 9.61 19 169308 630 64328775
Muscle injury 28.50 9.61 17 169310 26420 64302985
Fungaemia 28.48 9.61 42 169285 3743 64325662
Toxic skin eruption 28.37 9.61 113 169214 19171 64310234
Poisoning 28.26 9.61 11 169316 21868 64307537
Vulvovaginal burning sensation 28.25 9.61 24 169303 1155 64328250
Muscular weakness 28.00 9.61 480 168847 126858 64202547
Cardiac failure 27.91 9.61 218 169109 132155 64197250
Pregnancy 27.78 9.61 10 169317 20855 64308550
Anorectal ulcer 27.72 9.61 9 169318 50 64329355
Non-consummation 27.72 9.61 9 169318 50 64329355
Diabetes mellitus 27.68 9.61 86 169241 66388 64263017
Penile haemorrhage 27.64 9.61 17 169310 490 64328915
Abdominal abscess 27.61 9.61 55 169272 6249 64323156
Dyspnoea 27.41 9.61 1576 167751 717098 63612307
Multiple sclerosis relapse 27.30 9.61 41 169286 41094 64288311
Hypotony of eye 27.29 9.61 13 169314 221 64329184
Motor neurone disease 27.24 9.61 16 169311 423 64328982
Flushing 27.24 9.61 110 169217 78538 64250867
Corneal opacity 27.14 9.61 21 169306 884 64328521
Prostatitis 27.11 9.61 40 169287 3566 64325839
Blood glucose increased 27.01 9.61 149 169178 97924 64231481
Depersonalisation/derealisation disorder 26.88 9.61 27 169300 1613 64327792
Impaired healing 26.79 9.61 76 169251 60397 64269008
Moraxella test positive 26.64 9.61 7 169320 15 64329390
Lymphocyte count decreased 26.59 9.61 41 169286 40658 64288747
Diverticulitis 26.48 9.61 183 169144 38435 64290970
Lung consolidation 26.29 9.61 61 169266 7697 64321708
Oliguria 26.11 9.61 91 169236 14485 64314920
Urinary tract infection 26.03 9.61 794 168533 230802 64098603
Sensory disturbance 25.90 9.61 85 169242 13123 64316282
Hypotension 25.88 9.61 782 168545 380192 63949213
Mineral deficiency 25.84 9.61 8 169319 37 64329368
Pulmonary hypertension 25.82 9.61 46 169281 43093 64286312
Injection site pruritus 25.79 9.61 37 169290 37789 64291616
Staphylococcal infection 25.77 9.61 224 169103 50454 64278951
Intentional self-injury 25.69 9.61 23 169304 29021 64300384
Pudendal canal syndrome 25.53 9.61 6 169321 6 64329399
Night sweats 25.42 9.61 172 169155 35874 64293531
Rash 25.32 9.61 1458 167869 457091 63872314
Trichosporon infection 25.24 9.61 20 169307 872 64328533
Abscess intestinal 25.11 9.61 31 169296 2329 64327076
Cholestatic liver injury 25.10 9.61 39 169288 3640 64325765
Incorrect route of product administration 25.09 9.61 15 169312 23283 64306122
Increased bronchial secretion 25.03 9.61 34 169293 2808 64326597
Diabetic ketoacidosis 24.80 9.61 25 169302 29820 64299585
Toxic encephalopathy 24.74 9.61 69 169258 9746 64319659
Yellow fever vaccine-associated viscerotropic disease 24.73 9.61 5 169322 0 64329405
Ectropion 24.61 9.61 14 169313 348 64329057
Urosepsis 24.53 9.61 119 169208 21975 64307430
Sopor 24.47 9.61 25 169302 29636 64299769
Acute hepatic failure 24.38 9.61 134 169193 25978 64303427
Right ventricular failure 24.30 9.61 13 169314 21458 64307947
Calcium ionised decreased 24.25 9.61 16 169311 522 64328883
Osteonecrosis 24.21 9.61 23 169304 28206 64301199
Sputum increased 24.05 9.61 38 169289 3597 64325808
Ependymoma 23.98 9.61 8 169319 49 64329356
Catatonia 23.75 9.61 58 169269 7562 64321843
Transmission of an infectious agent via product 23.64 9.61 11 169316 177 64329228
Mitochondrial cytopathy 23.54 9.61 14 169313 379 64329026
Septic embolus 23.52 9.61 26 169301 1736 64327669
Contusion 23.41 9.61 189 169138 113776 64215629
Drug dependence 23.29 9.61 32 169295 33280 64296125
Lower respiratory tract infection bacterial 23.23 9.61 17 169310 657 64328748
Depression 23.23 9.61 638 168689 182653 64146752
Rash erythematous 23.20 9.61 212 169115 48421 64280984
Cutaneous vasculitis 23.16 9.61 52 169275 6421 64322984
Flank pain 23.12 9.61 94 169233 16095 64313310
Pulmonary eosinophilia 23.11 9.61 16 169311 566 64328839
Orchitis 23.10 9.61 21 169306 1107 64328298
Bacterial colitis 23.07 9.61 9 169318 91 64329314
Cardiac arrest 23.04 9.61 276 169051 153788 64175617
Phlebitis 23.03 9.61 58 169269 7708 64321697
Somnolence 22.96 9.61 386 168941 203259 64126146
Aortic aneurysm 22.92 9.61 57 169270 7517 64321888
Clostridial infection 22.83 9.61 45 169282 5074 64324331
Chest injury 22.80 9.61 30 169297 2403 64327002
Headache 22.78 9.61 1147 168180 528320 63801085
Potentiating drug interaction 22.62 9.61 58 169269 7794 64321611
Coronary artery disease 22.55 9.61 82 169245 60351 64269054
Thrombotic thrombocytopenic purpura 22.45 9.61 49 169278 5935 64323470
Respiratory tract infection bacterial 22.32 9.61 18 169309 805 64328600
Escherichia urinary tract infection 22.30 9.61 76 169251 11961 64317444
Lumbosacral plexus injury 22.19 9.61 6 169321 15 64329390
Hyperkalaemia 22.04 9.61 165 169162 100964 64228441
Oesophageal spasm 21.92 9.61 30 169297 2495 64326910
Nosocomial infection 21.81 9.61 30 169297 2507 64326898
Fracture 21.76 9.61 11 169316 18744 64310661
Femur fracture 21.72 9.61 35 169292 34100 64295305
Incorrect dose administered 21.67 9.61 84 169243 60681 64268724
Skin burning sensation 21.56 9.61 69 169258 10514 64318891
Confabulation 21.54 9.61 14 169313 445 64328960
Type 2 diabetes mellitus 21.53 9.61 35 169292 33985 64295420
Diaphragmatic rupture 21.49 9.61 11 169316 220 64329185
Corneal deposits 21.47 9.61 13 169314 364 64329041
Herpes zoster 21.42 9.61 121 169206 79066 64250339
Tendon necrosis 21.27 9.61 5 169322 5 64329400
Inappropriate antidiuretic hormone secretion 21.22 9.61 115 169212 22174 64307231
Ischaemic stroke 21.21 9.61 27 169300 29008 64300397
Feeding intolerance 21.02 9.61 15 169312 557 64328848
Abdominal pain lower 20.93 9.61 130 169197 26339 64303066
Neoplasm progression 20.83 9.61 48 169279 40916 64288489
Auditory disorder 20.82 9.61 13 169314 385 64329020
Walking disability 20.81 9.61 25 169302 1826 64327579
Staphylococcal scalded skin syndrome 20.76 9.61 13 169314 387 64329018
Tooth disorder 20.72 9.61 17 169310 22385 64307020
Gastroenteritis pseudomonas 20.70 9.61 6 169321 21 64329384
Pyelonephritis 20.63 9.61 95 169232 17171 64312234
Blood pressure increased 20.46 9.61 324 169003 172228 64157177
Cystitis 20.34 9.61 186 169141 42489 64286916
Haemorrhagic vasculitis 20.33 9.61 8 169319 83 64329322
Hyperinsulinaemia 20.28 9.61 10 169317 184 64329221
Ligament disorder 20.27 9.61 12 169315 322 64329083
C-reactive protein abnormal 20.21 9.61 28 169299 29019 64300386
Fear of death 20.21 9.61 21 169306 1306 64328099
Bone marrow granuloma 20.08 9.61 6 169321 24 64329381
Aortic aneurysm rupture 20.06 9.61 20 169307 1184 64328221
Aeromonas infection 20.04 9.61 12 169315 329 64329076
Visual acuity reduced 20.04 9.61 131 169196 27010 64302395
Meningitis candida 20.03 9.61 9 169318 133 64329272
Metastases to liver 19.96 9.61 20 169307 23921 64305484
Influenza 19.94 9.61 181 169146 106350 64223055
Yellow fever vaccine-associated neurotropic disease 19.78 9.61 4 169323 0 64329405
Posterior tibial tendon dysfunction 19.78 9.61 4 169323 0 64329405
Renal vein compression 19.78 9.61 4 169323 0 64329405
Tendon laxity 19.78 9.61 4 169323 0 64329405
Respiratory arrest 19.70 9.61 72 169255 52913 64276492
Limb immobilisation 19.60 9.61 7 169320 54 64329351
Live birth 19.57 9.61 3 169324 11201 64318204
Electrocardiogram QT prolonged 19.51 9.61 305 169022 79143 64250262
Device malfunction 19.49 9.61 11 169316 17622 64311783
Product quality issue 19.48 9.61 30 169297 29769 64299636
Breast cancer 19.39 9.61 29 169298 29119 64300286
Leukocyturia 19.34 9.61 22 169305 1516 64327889
Asthma-chronic obstructive pulmonary disease overlap syndrome 19.32 9.61 19 169308 1106 64328299
Systemic inflammatory response syndrome 19.29 9.61 65 169262 10170 64319235
Swelling 19.28 9.61 300 169027 159918 64169487
Rectal tube insertion 19.26 9.61 5 169322 10 64329395
Crystal nephropathy 19.23 9.61 20 169307 1245 64328160
Cholestasis 19.12 9.61 191 169136 44681 64284724
Inflammatory marker increased 18.97 9.61 57 169270 8394 64321011
Bladder hypertrophy 18.93 9.61 14 169313 550 64328855
Chemical burns of eye 18.93 9.61 8 169319 101 64329304
Dyslexia 18.92 9.61 10 169317 214 64329191
Drug level increased 18.89 9.61 154 169173 34042 64295363
Hepatic cytolysis 18.83 9.61 80 169247 13969 64315436
Haematuria 18.80 9.61 242 169085 60229 64269176
Hip arthroplasty 18.78 9.61 17 169310 21334 64308071
Injection site mass 18.76 9.61 11 169316 17259 64312146
Restlessness 18.76 9.61 173 169154 39612 64289793
Pneumococcal sepsis 18.73 9.61 20 169307 1284 64328121
Skin oedema 18.69 9.61 21 169306 1427 64327978
Panic reaction 18.69 9.61 36 169291 3991 64325414
Subdural haematoma 18.58 9.61 28 169299 28026 64301379
Paraesthesia oral 18.56 9.61 76 169251 13055 64316350
Renal injury 18.52 9.61 85 169242 15344 64314061
Abdominal discomfort 18.51 9.61 352 168975 181970 64147435
Necrotising retinitis 18.35 9.61 18 169309 1045 64328360
Acute febrile neutrophilic dermatosis 18.27 9.61 32 169295 3297 64326108
Bacteriuria 18.25 9.61 17 169310 925 64328480
Gastrointestinal scarring 18.20 9.61 10 169317 232 64329173
Anuria 18.16 9.61 98 169229 18866 64310539
Cough 18.16 9.61 630 168697 301518 64027887
Prescribed overdose 18.10 9.61 16 169311 20315 64309090
Graft versus host disease 18.01 9.61 78 169249 13735 64315670
Vulvovaginal swelling 17.98 9.61 11 169316 314 64329091
Small fibre neuropathy 17.93 9.61 10 169317 239 64329166
Transient ischaemic attack 17.80 9.61 58 169269 44124 64285281
Sudden death 17.67 9.61 16 169311 20080 64309325
Myosclerosis 17.67 9.61 9 169318 178 64329227
Angina pectoris 17.60 9.61 60 169267 45021 64284384
May-Thurner syndrome 17.59 9.61 5 169322 16 64329389
Hyperpathia 17.55 9.61 4 169323 3 64329402
Parosmia 17.42 9.61 38 169289 4602 64324803
Adverse reaction 17.40 9.61 52 169275 7635 64321770
Biliary dyskinesia 17.39 9.61 26 169301 2346 64327059
Deafness bilateral 17.37 9.61 23 169304 1853 64327552
Myopathy 17.37 9.61 92 169235 17588 64311817
Vulvovaginal pain 17.33 9.61 22 169305 1700 64327705
Foot deformity 17.25 9.61 11 169316 16493 64312912
Adverse event 17.22 9.61 50 169277 39439 64289966
Stoma closure 17.18 9.61 8 169319 129 64329276
Cerebral infarction 17.16 9.61 53 169274 40991 64288414
Gastrointestinal inflammation 17.06 9.61 45 169282 6150 64323255
Epididymitis 17.01 9.61 22 169305 1732 64327673
Idiopathic intracranial hypertension 17.01 9.61 27 169300 2566 64326839
Fat tissue decreased 16.88 9.61 7 169320 84 64329321
Loss of personal independence in daily activities 16.86 9.61 116 169211 72338 64257067
Gastroenteritis staphylococcal 16.84 9.61 10 169317 270 64329135
Anhedonia 16.81 9.61 76 169251 13630 64315775
Acute psychosis 16.75 9.61 33 169294 3719 64325686
Jaundice 16.74 9.61 198 169129 48314 64281091
Visual snow syndrome 16.73 9.61 5 169322 20 64329385
Anal paraesthesia 16.73 9.61 5 169322 20 64329385
Diabetic macroangiopathy 16.64 9.61 8 169319 139 64329266
Dysaesthesia 16.62 9.61 39 169288 4956 64324449
Idiosyncratic drug reaction 16.54 9.61 18 169309 1181 64328224
Intestinal stenosis 16.49 9.61 30 169297 3184 64326221
Oxygen saturation decreased 16.40 9.61 191 169136 106985 64222420
Rectal tenesmus 16.38 9.61 17 169310 1056 64328349
Head injury 16.29 9.61 39 169288 32803 64296602
Injection site hyperaesthesia 16.20 9.61 6 169321 52 64329353
Oesophageal pain 16.17 9.61 30 169297 3233 64326172
Intestinal fistula 16.17 9.61 18 169309 1211 64328194
Ligament rupture 16.08 9.61 26 169301 2510 64326895
Myoclonus 16.04 9.61 117 169210 25001 64304404
Pneumonia pseudomonal 16.01 9.61 38 169289 4865 64324540
Mucosal hyperaemia 16.00 9.61 6 169321 54 64329351
Arthralgia 15.95 9.61 1358 167969 440902 63888503
Documented hypersensitivity to administered product 15.84 9.61 15 169312 833 64328572
Pneumonia aspiration 15.80 9.61 91 169236 59180 64270225
Pulmonary pain 15.72 9.61 26 169301 2558 64326847
Retinitis viral 15.67 9.61 7 169320 102 64329303
Bladder trabeculation 15.62 9.61 6 169321 58 64329347
Chronic gastrointestinal bleeding 15.57 9.61 11 169316 402 64329003
Hypersensitivity vasculitis 15.56 9.61 46 169281 6715 64322690
Sedation complication 15.52 9.61 4 169323 10350 64319055
Schizophrenia 15.48 9.61 5 169322 11163 64318242
Product contamination microbial 15.33 9.61 15 169312 868 64328537
Stomatococcal infection 15.19 9.61 9 169318 242 64329163
Tongue geographic 15.18 9.61 6 169321 63 64329342
Female genital tract fistula 15.18 9.61 26 169301 2632 64326773
Prothrombin time shortened 15.14 9.61 27 169300 2822 64326583
Knee arthroplasty 15.09 9.61 30 169297 26969 64302436
Prolapse 15.09 9.61 4 169323 9 64329396
Neurotransmitter level altered 15.09 9.61 4 169323 9 64329396
Underdose 15.05 9.61 28 169299 25801 64303604
Ill-defined disorder 15.01 9.61 62 169265 43990 64285415
Basal cell carcinoma 14.99 9.61 37 169290 30801 64298604
Systemic candida 14.98 9.61 39 169288 5290 64324115
Blood cholesterol increased 14.94 9.61 74 169253 49992 64279413
Activated partial thromboplastin time prolonged 14.89 9.61 70 169257 12761 64316644
Hospitalisation 14.86 9.61 126 169201 75081 64254324
Skin test positive 14.86 9.61 16 169311 1037 64328368
Intrauterine infection 14.86 9.61 6 169321 67 64329338
Injection site joint erythema 14.84 9.61 3 169324 0 64329405
Generalised tonic-clonic seizure 14.80 9.61 165 169162 39692 64289713
Gluten sensitivity 14.77 9.61 10 169317 341 64329064
Red blood cell count decreased 14.73 9.61 71 169256 48315 64281090
Eye infection fungal 14.70 9.61 11 169316 440 64328965
Spinal fracture 14.68 9.61 11 169316 15163 64314242
COVID-19 pneumonia 14.68 9.61 13 169314 16491 64312914
Necrosis 14.62 9.61 51 169276 8120 64321285
Cataract 14.60 9.61 77 169250 51185 64278220
Deficiency of bile secretion 14.55 9.61 5 169322 34 64329371
Atrioventricular block complete 14.54 9.61 10 169317 14408 64314997
Infrequent bowel movements 14.53 9.61 18 169309 1357 64328048
Enterovesical fistula 14.45 9.61 15 169312 932 64328473
Erythema 14.28 9.61 614 168713 186456 64142949
Proctalgia 14.24 9.61 48 169279 7511 64321894
Hepatitis infectious mononucleosis 14.24 9.61 7 169320 128 64329277
Bacteraemia 14.23 9.61 120 169207 26791 64302614
Histamine intolerance 14.18 9.61 5 169322 37 64329368
Rash papular 14.13 9.61 85 169242 17028 64312377
Arrhythmia 14.06 9.61 206 169121 52738 64276667
Increased viscosity of bronchial secretion 13.99 9.61 11 169316 474 64328931
Clostridium bacteraemia 13.99 9.61 9 169318 281 64329124
Staphylococcal sepsis 13.98 9.61 69 169258 12830 64316575
Pain in extremity 13.97 9.61 949 168378 302136 64027269
Lip erosion 13.93 9.61 17 169310 1262 64328143
Rhabdomyolysis 13.88 9.61 327 169000 91399 64238006
Troponin increased 13.85 9.61 12 169315 15387 64314018
Groin pain 13.85 9.61 63 169264 11330 64318075
Endocarditis 13.83 9.61 55 169272 9323 64320082
Drain placement 13.81 9.61 7 169320 137 64329268
Multiple-drug resistance 13.80 9.61 43 169284 6459 64322946
Uveitis 13.79 9.61 68 169259 12640 64316765
Skin laceration 13.76 9.61 27 169300 24390 64305015
Post transplant lymphoproliferative disorder 13.72 9.61 4 169323 9540 64319865
Exercise tolerance decreased 13.69 9.61 48 169279 7662 64321743
Device issue 13.69 9.61 24 169303 22624 64306781
Pseudomonal sepsis 13.67 9.61 37 169290 5135 64324270
Disease progression 13.63 9.61 276 169051 141404 64188001
Fluid retention 13.59 9.61 96 169231 59510 64269895
Mobility decreased 13.51 9.61 152 169175 85688 64243717
Clostridium colitis 13.51 9.61 24 169303 2501 64326904
Therapy partial responder 13.49 9.61 5 169322 10243 64319162
Haemorrhage urinary tract 13.43 9.61 22 169305 2147 64327258
Mucosal inflammation 13.42 9.61 235 169092 62349 64267056
Face oedema 13.40 9.61 111 169216 24650 64304755
Peripheral nerve injury 13.34 9.61 12 169315 624 64328781
Bovine tuberculosis 13.32 9.61 7 169320 148 64329257
Mouth ulceration 13.30 9.61 137 169190 32307 64297098
Sitting disability 13.28 9.61 7 169320 149 64329256
Exfoliative rash 13.26 9.61 29 169298 3517 64325888
Acid base balance abnormal 13.26 9.61 9 169318 308 64329097
Gastrointestinal haemorrhage 13.26 9.61 256 169071 132056 64197349
Seroconversion test positive 13.24 9.61 5 169322 46 64329359
Psoas abscess 13.23 9.61 14 169313 889 64328516
Withdrawal syndrome 13.22 9.61 26 169301 23466 64305939
Faecal volume decreased 13.20 9.61 7 169320 151 64329254
Faciobrachial dystonic seizure 13.19 9.61 4 169323 17 64329388
Chronic obstructive pulmonary disease 13.17 9.61 121 169206 70927 64258478
Abortion spontaneous 13.16 9.61 29 169298 25114 64304291
Treatment noncompliance 13.13 9.61 64 169263 43418 64285987
Pyuria 13.10 9.61 21 169306 2012 64327393
Complex regional pain syndrome 13.02 9.61 19 169308 1677 64327728
Post infection glomerulonephritis 13.01 9.61 4 169323 18 64329387
Impaired quality of life 13.01 9.61 42 169285 6429 64322976
Anxiety disorder 12.98 9.61 30 169297 3775 64325630
Administration site swelling 12.96 9.61 9 169318 320 64329085
Myocardial ischaemia 12.86 9.61 26 169301 23225 64306180
Large intestinal stenosis 12.83 9.61 23 169304 2414 64326991
Performance status decreased 12.83 9.61 37 169290 5327 64324078
Angina unstable 12.80 9.61 13 169314 15454 64313951
Organ failure 12.79 9.61 29 169298 3604 64325801
Vertebral artery hypoplasia 12.76 9.61 3 169324 3 64329402
Aeromonas test positive 12.76 9.61 3 169324 3 64329402
Tachypnoea 12.76 9.61 116 169211 26455 64302950
Peritoneal adhesions 12.74 9.61 9 169318 329 64329076
Glare 12.70 9.61 6 169321 100 64329305
Frequent bowel movements 12.70 9.61 87 169240 18218 64311187
Sleep disorder due to a general medical condition 12.69 9.61 3 169324 8231 64321174
Fusarium infection 12.67 9.61 18 169309 1551 64327854
Throat tightness 12.63 9.61 104 169223 23056 64306349
Hypophosphataemia 12.61 9.61 12 169315 14708 64314697
Chest pain 12.61 9.61 499 168828 235481 64093924
Infusion site streaking 12.60 9.61 10 169317 437 64328968
Hypercreatininaemia 12.60 9.61 13 169314 802 64328603
Tonsillar haemorrhage 12.52 9.61 8 169319 247 64329158
C-reactive protein decreased 12.48 9.61 21 169306 2095 64327310
Cholecystitis acute 12.48 9.61 61 169266 11299 64318106
Nervousness 12.47 9.61 38 169289 29518 64299887
Stenotrophomonas infection 12.45 9.61 26 169301 3054 64326351
Product complaint 12.45 9.61 8 169319 11946 64317459
Painful respiration 12.45 9.61 26 169301 3055 64326350
Neurological symptom 12.42 9.61 43 169284 6821 64322584
Single functional kidney 12.39 9.61 6 169321 106 64329299
Organic brain syndrome 12.39 9.61 10 169317 448 64328957
Corynebacterium infection 12.37 9.61 14 169313 959 64328446
Pruritus 12.33 9.61 966 168361 311434 64017971
Agranulocytosis 12.31 9.61 154 169173 38075 64291330
Stenotrophomonas test positive 12.25 9.61 9 169318 350 64329055
Cardiac disorder 12.19 9.61 91 169236 55725 64273680
Colour blindness acquired 12.14 9.61 6 169321 111 64329294
Penile blister 12.13 9.61 5 169322 59 64329346
Purple glove syndrome 12.10 9.61 8 169319 262 64329143
Fistula discharge 12.06 9.61 14 169313 986 64328419
Anal skin tags 12.05 9.61 9 169318 359 64329046
Metastases to bone 12.04 9.61 22 169305 20413 64308992
Vasculitis 11.96 9.61 85 169242 18010 64311395
Bronchitis 11.96 9.61 207 169120 108536 64220869
Road traffic accident 11.95 9.61 41 169286 30704 64298701
Basophil count abnormal 11.92 9.61 4 169323 25 64329380
Factor XIII Inhibition 11.92 9.61 4 169323 25 64329380
Hallucinations, mixed 11.91 9.61 39 169288 6013 64323392
Tongue coated 11.86 9.61 15 169312 1155 64328250
Pancytopenia 11.76 9.61 474 168853 142835 64186570
Burning mouth syndrome 11.72 9.61 10 169317 484 64328921
Joint instability 11.71 9.61 16 169311 1329 64328076
White blood cell count decreased 11.70 9.61 320 169007 157517 64171888
Subacute cutaneous lupus erythematosus 11.61 9.61 25 169302 3000 64326405
Kounis syndrome 11.61 9.61 25 169302 3000 64326405
Glycosylated haemoglobin increased 11.59 9.61 15 169312 16004 64313401
Accidental overdose 11.57 9.61 47 169280 33510 64295895
Haemolytic anaemia 11.56 9.61 77 169250 15976 64313429
Food allergy 11.54 9.61 46 169281 7805 64321600
Mitochondrial enzyme deficiency 11.54 9.61 4 169323 28 64329377
Chromaturia 11.52 9.61 100 169227 22511 64306894
Urethral pain 11.45 9.61 9 169318 388 64329017
Product deposit 11.41 9.61 9 169318 390 64329015
Sedation 11.41 9.61 63 169264 41399 64288006
Calculus bladder 11.36 9.61 15 169312 1205 64328200
Enterocutaneous fistula 11.32 9.61 17 169310 1540 64327865
Anorectal discomfort 11.26 9.61 24 169303 2861 64326544
Product storage error 11.25 9.61 11 169316 13307 64316098
Microbiology test abnormal 11.24 9.61 3 169324 7 64329398
Orchitis noninfective 11.24 9.61 3 169324 7 64329398
Feeling jittery 11.24 9.61 7 169320 10628 64318777
Tremor 11.19 9.61 486 168841 147744 64181661
Hepatic encephalopathy 11.17 9.61 94 169233 20972 64308433
Miosis 11.15 9.61 11 169316 13255 64316150
Burnout syndrome 11.14 9.61 8 169319 300 64329105
Irritability 11.14 9.61 54 169273 36692 64292713
Cardiac discomfort 11.10 9.61 14 169313 1075 64328330
Testicular pain 11.10 9.61 18 169309 1742 64327663
Pelvic fracture 11.10 9.61 7 169320 10556 64318849
Interstitial lung disease 11.08 9.61 185 169142 97547 64231858
Vulvovaginal candidiasis 11.08 9.61 20 169307 2110 64327295
Candida osteomyelitis 11.08 9.61 4 169323 32 64329373
Hypersensitivity 11.02 9.61 413 168914 196039 64133366
Pain of skin 11.02 9.61 52 169275 9495 64319910
Papilloma 10.98 9.61 8 169319 307 64329098
Roseola 10.96 9.61 3 169324 8 64329397
Loss of consciousness 10.94 9.61 301 169026 148064 64181341
Long QT syndrome 10.92 9.61 34 169293 5105 64324300
Ankylosing spondylitis 10.87 9.61 4 169323 8230 64321175
Nephropathy toxic 10.85 9.61 81 169246 17433 64311972
Coeliac disease 10.85 9.61 3 169324 7409 64321996
Gastrointestinal pain 10.83 9.61 44 169283 7530 64321875
Hyperchlorhydria 10.81 9.61 18 169309 1781 64327624
Sense of oppression 10.81 9.61 16 169311 1431 64327974
Neuropsychiatric symptoms 10.78 9.61 13 169314 953 64328452
Gastrointestinal infection 10.77 9.61 46 169281 8050 64321355
Lower respiratory tract infection 10.76 9.61 179 169148 94435 64234970
Altered state of consciousness 10.75 9.61 57 169270 37845 64291560
Glomerular filtration rate decreased 10.72 9.61 22 169305 19550 64309855
Drug ineffective for unapproved indication 10.71 9.61 127 169200 31006 64298399
Scar excision 10.67 9.61 4 169323 36 64329369
Herpes zoster meningoencephalitis 10.65 9.61 11 169316 679 64328726
Neuroleptic malignant syndrome 10.64 9.61 32 169295 24964 64304441
Overgrowth bacterial 10.63 9.61 6 169321 147 64329258
Hypoxia 10.61 9.61 165 169162 87984 64241421
Culture stool positive 10.60 9.61 10 169317 553 64328852
Inflammation 10.56 9.61 235 169092 65065 64264340
Cytokine release syndrome 10.55 9.61 92 169235 20737 64308668
Blood creatine increased 10.48 9.61 46 169281 8146 64321259
Metatarsal excision 10.46 9.61 3 169324 10 64329395
Fluorosis 10.45 9.61 5 169322 86 64329319
Lupus-like syndrome 10.43 9.61 5 169322 8786 64320619
Progressive multifocal leukoencephalopathy 10.41 9.61 20 169307 18212 64311193
Left ventricular hypertrophy 10.41 9.61 6 169321 9500 64319905
Injection site haemorrhage 10.40 9.61 31 169296 24247 64305158
Perineal pain 10.39 9.61 13 169314 990 64328415
Renal pain 10.36 9.61 41 169286 6933 64322472
Lactic acidosis 10.36 9.61 107 169220 61303 64268102
Inappropriate schedule of product administration 10.36 9.61 175 169152 92111 64237294
Petechiae 10.35 9.61 84 169243 18542 64310863
Rebound acid hypersecretion 10.34 9.61 5 169322 88 64329317
Therapeutic response unexpected 10.29 9.61 18 169309 16983 64312422
Anal inflammation 10.23 9.61 9 169318 454 64328951
Intestinal dilatation 10.21 9.61 20 169307 2244 64327161
Prostatic disorder 10.21 9.61 17 169310 1682 64327723
Tongue disorder 10.17 9.61 10 169317 12070 64317335
Cholelithiasis 10.16 9.61 172 169155 45334 64284071
Skin exfoliation 10.15 9.61 170 169157 44715 64284690
Flavobacterium infection 10.14 9.61 5 169322 92 64329313
Infusion site reaction 10.11 9.61 19 169308 2067 64327338
Incorrect product dosage form administered 10.10 9.61 6 169321 162 64329243
Hepatic amoebiasis 10.09 9.61 5 169322 93 64329312
Prescribed underdose 10.08 9.61 20 169307 17995 64311410
Bundle branch block left 10.07 9.61 7 169320 10027 64319378
Full blood count abnormal 10.06 9.61 42 169285 29715 64299690
Procalcitonin increased 10.04 9.61 21 169306 2470 64326935
Skin injury 10.03 9.61 19 169308 2080 64327325
Ventricular tachyarrhythmia 10.03 9.61 7 169320 251 64329154
Toxic shock syndrome 10.02 9.61 12 169315 874 64328531
Abnormal faeces 10.00 9.61 36 169291 5823 64323582
Pneumonia fungal 9.99 9.61 48 169279 8829 64320576
Medical device site pain 9.98 9.61 7 169320 253 64329152
Biopsy colon abnormal 9.95 9.61 5 169322 96 64329309
Needle issue 9.94 9.61 6 169321 9266 64320139
Infective exacerbation of bronchiectasis 9.92 9.61 11 169316 737 64328668
Penile pain 9.92 9.61 12 169315 883 64328522
Peripheral arterial occlusive disease 9.91 9.61 3 169324 6984 64322421
Aural polyp 9.90 9.61 5 169322 97 64329308
Taste disorder 9.90 9.61 50 169277 9383 64320022
Splenic abscess 9.89 9.61 9 169318 475 64328930
Diarrhoea infectious 9.89 9.61 15 169312 1371 64328034
Fatigue 9.87 9.61 1773 167554 746957 63582448
Tooth fracture 9.86 9.61 7 169320 9920 64319485
Immunodeficiency 9.82 9.61 17 169310 16107 64313298
Osteopenia 9.82 9.61 16 169311 15524 64313881
Renal abscess 9.79 9.61 12 169315 895 64328510
Fungal infection 9.79 9.61 135 169192 34116 64295289
Leukopenia 9.78 9.61 341 168986 100901 64228504
Coagulation time prolonged 9.73 9.61 19 169308 2127 64327278
Candida test positive 9.73 9.61 13 169314 1057 64328348
Injection site urticaria 9.72 9.61 9 169318 11172 64318233
Vision blurred 9.69 9.61 308 169019 90008 64239397
Liver function test increased 9.69 9.61 45 169282 30925 64298480
White blood cells urine 9.69 9.61 8 169319 370 64329035
Pseudomonas test positive 9.69 9.61 16 169311 1572 64327833
Vascular purpura 9.67 9.61 21 169306 2535 64326870
Vipoma 9.67 9.61 3 169324 14 64329391
Internal haemorrhage 9.67 9.61 4 169323 7663 64321742
Ligament injury 9.66 9.61 13 169314 1064 64328341
Injection site streaking 9.65 9.61 4 169323 48 64329357
Blood urine 9.65 9.61 11 169316 760 64328645
Encephalopathy 9.62 9.61 212 169115 58607 64270798

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC J01MA02 ANTIINFECTIVES FOR SYSTEMIC USE
ANTIBACTERIALS FOR SYSTEMIC USE
QUINOLONE ANTIBACTERIALS
Fluoroquinolones
ATC J01RA10 ANTIINFECTIVES FOR SYSTEMIC USE
ANTIBACTERIALS FOR SYSTEMIC USE
COMBINATIONS OF ANTIBACTERIALS
Combinations of antibacterials
ATC J01RA11 ANTIINFECTIVES FOR SYSTEMIC USE
ANTIBACTERIALS FOR SYSTEMIC USE
COMBINATIONS OF ANTIBACTERIALS
Combinations of antibacterials
ATC J01RA12 ANTIINFECTIVES FOR SYSTEMIC USE
ANTIBACTERIALS FOR SYSTEMIC USE
COMBINATIONS OF ANTIBACTERIALS
Combinations of antibacterials
ATC S01AE03 SENSORY ORGANS
OPHTHALMOLOGICALS
ANTIINFECTIVES
Fluoroquinolones
ATC S02AA15 SENSORY ORGANS
OTOLOGICALS
ANTIINFECTIVES
Antiinfectives
ATC S03AA07 SENSORY ORGANS
OPHTHALMOLOGICAL AND OTOLOGICAL PREPARATIONS
ANTIINFECTIVES
Antiinfectives
FDA CS M0023650 Quinolones
MeSH PA D000900 Anti-Bacterial Agents
MeSH PA D000890 Anti-Infective Agents
MeSH PA D000970 Antineoplastic Agents
MeSH PA D065609 Cytochrome P-450 CYP1A2 Inhibitors
MeSH PA D065607 Cytochrome P-450 Enzyme Inhibitors
MeSH PA D004791 Enzyme Inhibitors
MeSH PA D065606 Metabolic Side Effects of Drugs and Substances
MeSH PA D059005 Topoisomerase II Inhibitors
FDA EPC N0000175937 Quinolone Antimicrobial
CHEBI has role CHEBI:35441 antiinfective agents
CHEBI has role CHEBI:36047 antibacterial drugs
CHEBI has role CHEBI:50750 inhibitors of type II topoisomerase
CHEBI has role CHEBI:53559 topoisomerase IV inhibitors
CHEBI has role CHEBI:33281 antibiotics
CHEBI has role CHEBI:35703 Xenobiotic
CHEBI has role CHEBI:59517 DNA synthesis inhibitors
CHEBI has role CHEBI:78298 environmental contaminants

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

DiseaseRelationSNOMED_IDDOID
Otitis externa indication 3135009
Typhoid fever indication 4834000 DOID:13258
Septicemia due to Escherichia coli indication 9323009
Prostatitis indication 9713002 DOID:14654
Infection due to Pseudomonas aeruginosa indication 11218009
Enteric campylobacteriosis indication 18081009
Infectious diarrheal disease indication 19213003 DOID:13250
Infection of skin AND/OR subcutaneous tissue indication 19824006
Acute gonococcal cervicitis indication 20943002 DOID:10615
Acute gonococcal urethritis indication 29864006
Acute bacterial peritonitis indication 31860008
Pneumonia due to Streptococcus indication 34020007
Shigellosis indication 36188001
Cystitis indication 38822007 DOID:1679
Pneumonia due to Pseudomonas indication 41381004
Lower respiratory tract infection indication 50417007
Pneumonia due to Escherichia coli indication 51530003
Bacterial pneumonia indication 53084003 DOID:874
Klebsiella cystitis indication 60867007
Acute maxillary sinusitis indication 68272006 DOID:2050
Haemophilus influenzae pneumonia indication 70036007
Infection due to Escherichia coli indication 71057007
Rhinoscleroma indication 72409005 DOID:11336
Abdominal abscess indication 75100008
Acute bacterial sinusitis indication 75498004
Infective otitis externa indication 86981007 DOID:9463
Infection of bone indication 111253001
Infectious disease of abdomen indication 128070006
Bacterial conjunctivitis indication 128350005 DOID:9700
Infection due to Enterobacteriaceae indication 128945009
Bacterial infection due to Klebsiella pneumoniae indication 186435004
Acute Moraxella catarrhalis bronchitis indication 195722003
Proteus pneumonia indication 195888009
Malignant otitis externa due to Pseudomonas aeruginosa indication 232230009
Acute bacterial bronchitis indication 233598009
Infective cystitis indication 236620008
Chancroid indication 266143009 DOID:13778
Escherichia coli urinary tract infection indication 301011002
Proteus urinary tract infection indication 301012009
Streptococcus pyogenes infection indication 302809008
Bacterial urinary infection indication 312124009
Infective otitis media indication 312218008
Infectious disorder of joint indication 363162000
Infection due to Staphylococcus aureus indication 406602003
Anthrax indication 409498004 DOID:7427
Acute osteomyelitis indication 409780002
Nosocomial pneumonia indication 425464007
Urinary tract infection caused by Klebsiella indication 369001000119100
Pseudomonas Aeruginosa Joint Infection indication
Complicated UTI with Pseudomonas Aeruginosa indication
Staphylococcus Epidermidis Urinary Tract Infection indication
Complicated Proteus UTI indication
Skin and Skin Structure Providencia Infection indication
Complicated Bacterial Peritonitis indication
Staphylococcus Saprophyticus Urinary Tract Infection indication
Haemophilus Parainfluenzae Pneumonia indication
Enterobacter Pneumonia indication
Skin and Skin Structure Citrobacter Infection indication
Moraxella Catarrhalis Chronic Bronchitis indication
Diarrhea due to E. Coli indication
Skin and Skin Structure Pseudomonas Aeruginosa Infection indication
Klebsiella Nosocomial Pneumonia indication
Citrobacter Urinary Tract Infection indication
Enterococcus Urinary Tract Infection indication
Serratia Joint Infection indication
Skin and Skin Structure Proteus Infection indication
EnterobacterJoint Infection indication
Enterobacter Osteomyelitis indication
Nosocomial Pneumonia due to Haemophilus Influenzae indication
Complicated Bacteroides Peritonitis indication
Complicated E. Coli Peritonitis indication
Morganella Morganii Urinary Tract Infection indication
Bacterial Corneal Ulcer Infection indication
Enterococcus Complicated UTI indication
Providencia Urinary Tract Infection indication
E. Coli Cystitis indication
Staphylococcus Aureus Otitis Externa indication
Staphylococcus Cystitis indication
Chronic Bacterial Prostatitis indication
Pseudomonas Aeruginosa Urinary Tract Infection indication
Gram-Negative Aerobic Bacillary Pneumonia indication
Serratia Osteomyelitis indication
Staphylococcus Epidermidis Skin and Skin Structure Infection indication
Complicated Klebsiella Peritonitis indication
Skin and Skin Structure Serratia Infection indication
Proteus Prostatitis indication
E. Coli Pyelonephritis indication
Skin and Skin Structure Morganella Morganii Infection indication
Serratia Urinary Tract Infection indication
Pseudomonas Aeruginosa Osteomyelitis indication
Inhalational anthrax off-label use 11389007
Traveler's diarrhea off-label use 11840006
Salmonella septicemia off-label use 49786009
Cutaneous anthrax off-label use 84980006 DOID:7426
Gastrointestinal anthrax off-label use 111798006 DOID:13386
Diverticulitis of gastrointestinal tract off-label use 271366000
Ventilator-acquired pneumonia off-label use 429271009
Prevention of Meningococcal Meningitis off-label use
Diabetic Foot Infection off-label use
Achilles tendinitis contraindication 11654001
Lowered convulsive threshold contraindication 19260006
Torsades de pointes contraindication 31722008
Transplantation of heart contraindication 32413006
Tendinitis contraindication 34840004 DOID:971
Hypokalemia contraindication 43339004
Transplant of kidney contraindication 70536003
Epilepsy contraindication 84757009 DOID:1826
Transplant of lung contraindication 88039007
Kidney disease contraindication 90708001 DOID:557
Myasthenia gravis contraindication 91637004 DOID:437
Prolonged QT interval contraindication 111975006
Superimposed infection contraindication 193198003
Peripheral nerve disease contraindication 302226006
Viral ear infection contraindication 312137007
Pseudomembranous enterocolitis contraindication 397683000
Traumatic rupture of tendon contraindication 415749005
Congenital long QT syndrome contraindication 442917000
Shoulder Tendonitis contraindication




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 6.12 acidic
pKa2 8.54 Basic
pKa3 1.37 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
0.3%;0.1% CIPRODEX NOVARTIS N021537 July 18, 2003 RX SUSPENSION/DROPS OTIC 9149486 Sept. 13, 2022 TREATMENT OF ACUTE OTITIS MEDIA
0.3%;0.1% CIPRODEX NOVARTIS N021537 July 18, 2003 RX SUSPENSION/DROPS OTIC 9345714 Sept. 13, 2022 TREATMENT OF ACUTE OTITIS MEDIA
0.3%;0.1% CIPRODEX NOVARTIS N021537 July 18, 2003 RX SUSPENSION/DROPS OTIC 9402805 Sept. 13, 2022 TREATMENT OF ACUTE OTITIS EXTERNA
0.3%;0.1% CIPRODEX NOVARTIS N021537 July 18, 2003 RX SUSPENSION/DROPS OTIC 9402805 Sept. 13, 2022 TREATMENT OF ACUTE OTITIS MEDIA
0.3%;0.1% CIPRODEX NOVARTIS N021537 July 18, 2003 RX SUSPENSION/DROPS OTIC 8846650 June 4, 2025 TREATMENT OF ACUTE OTITIS MEDIA
6% (60MG/ML) OTIPRIO ALK ABELLO N207986 Dec. 10, 2015 RX INJECTABLE, SUSPENSION OTIC 9205048 April 21, 2029 TREATMENT OF PEDIATRIC PATIENTS WITH OTITIS MEDIA WITH EFFUSION UNDERGOING TYMPANOSTOMY TUBE PLACEMENT
6% (60MG/ML) OTIPRIO ALK ABELLO N207986 Dec. 10, 2015 RX INJECTABLE, SUSPENSION OTIC 9603796 April 21, 2029 THE TREATMENT OF ACUTE OTITIS EXTERNA IN PATIENTS 6 MONTHS OF AGE AND OLDER DUE TO PSEUDOMONAS AERUGINOSA AND STAPHYLOCOCCUS AUREUS
EQ 0.3% BASE;0.025% OTOVEL LABORATORIOS SALVAT N208251 April 29, 2016 RX SOLUTION/DROPS OTIC 8932610 March 24, 2030 TREATMENT OF ACUTE OTITIS MEDIA
6% (60MG/ML) OTIPRIO ALK ABELLO N207986 Dec. 10, 2015 RX INJECTABLE, SUSPENSION OTIC 8318817 April 27, 2030 TREATMENT OF OTIC INFECTION OR INFLAMMATION
6% (60MG/ML) OTIPRIO ALK ABELLO N207986 Dec. 10, 2015 RX INJECTABLE, SUSPENSION OTIC 11040004 Nov. 12, 2037 THE TREATMENT OF ACUTE OTITIS EXTERNA IN PATIENTS 6 MONTHS OF AGE AND OLDER DUE TO PSEUDOMONAS AERUGINOSA AND STAPHYLOCOCCUS AUREUS

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])		Mechanism
action		Bioact sourceMoA source
DNA topoisomerase II Enzyme EC50 7.52 CHEMBL
DNA gyrase subunit A Enzyme INHIBITOR IC50 5.75 WOMBAT-PK CHEMBL
DNA topoisomerase 4 subunit A Enzyme IC50 5.66 WOMBAT-PK
DNA topoisomerase 4 subunit A Enzyme INHIBITOR IC50 6 WOMBAT-PK
DNA gyrase subunit A Enzyme IC50 6.20 WOMBAT-PK
Histamine H3 receptor GPCR Ki 9.18 CHEMBL
GABA-A receptor; anion channel Ion channel IC50 6.39 CHEMBL
DNA topoisomerase 4 subunit A Enzyme IC50 5.60 WOMBAT-PK
Multidrug resistance protein mdtK Unclassified Kd 4.04 CHEMBL

External reference:

IDSource
4019307 VUID
N0000147503 NUI
D00186 KEGG_DRUG
86393-32-0 SECONDARY_CAS_RN
235851 RXNORM
4019306 VANDF
4019307 VANDF
C0008809 UMLSCUI
CHEBI:100241 CHEBI
CPF PDB_CHEM_ID
CHEMBL8 ChEMBL_ID
DB00537 DRUGBANK_ID
CHEMBL1202 ChEMBL_ID
D002939 MESH_DESCRIPTOR_UI
2764 PUBCHEM_CID
10902 IUPHAR_LIGAND_ID
5446 INN_ID
97867-33-9 SECONDARY_CAS_RN
5E8K9I0O4U UNII
31644 MMSL
4451 MMSL
4452 MMSL
46904 MMSL
76342 MMSL
d00011 MMSL
002882 NDDF
003577 NDDF
004125 NDDF
20450009 SNOMEDCT_US
372840008 SNOMEDCT_US
428384006 SNOMEDCT_US
7577004 SNOMEDCT_US
CHEMBL1077975 ChEMBL_ID

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Ciloxan HUMAN PRESCRIPTION DRUG LABEL 1 0065-0656 SOLUTION/ DROPS 3 mg OPHTHALMIC NDA 21 sections
Ciloxan HUMAN PRESCRIPTION DRUG LABEL 1 0065-0656 SOLUTION/ DROPS 3 mg OPHTHALMIC NDA 21 sections
CIPROHC HUMAN PRESCRIPTION DRUG LABEL 2 0065-8531 SUSPENSION 2 mg AURICULAR (OTIC) NDA 16 sections
CIPRODEX HUMAN PRESCRIPTION DRUG LABEL 2 0078-0799 SUSPENSION/ DROPS 3 mg AURICULAR (OTIC) NDA 28 sections
CIPRODEX HUMAN PRESCRIPTION DRUG LABEL 2 0078-0799 SUSPENSION/ DROPS 3 mg AURICULAR (OTIC) NDA 28 sections
CILOXAN HUMAN PRESCRIPTION DRUG LABEL 1 0078-0841 OINTMENT 3 mg OPHTHALMIC NDA 20 sections
CILOXAN HUMAN PRESCRIPTION DRUG LABEL 1 0078-0841 OINTMENT 3 mg OPHTHALMIC NDA 20 sections
CIPROHC HUMAN PRESCRIPTION DRUG LABEL 2 0078-0855 SUSPENSION/ DROPS 2 mg AURICULAR (OTIC) NDA 16 sections
Ciprofloxacin HUMAN PRESCRIPTION DRUG LABEL 1 0143-9927 TABLET, FILM COATED 250 mg ORAL ANDA 30 sections
Ciprofloxacin HUMAN PRESCRIPTION DRUG LABEL 1 0143-9928 TABLET, FILM COATED 500 mg ORAL ANDA 30 sections
Ciprofloxacin HUMAN PRESCRIPTION DRUG LABEL 1 0143-9929 TABLET, FILM COATED 750 mg ORAL ANDA 30 sections
Ciprofloxacin HUMAN PRESCRIPTION DRUG LABEL 1 0172-5311 TABLET, FILM COATED 250 mg ORAL ANDA 29 sections
Ciprofloxacin HUMAN PRESCRIPTION DRUG LABEL 1 0172-5312 TABLET, FILM COATED 500 mg ORAL ANDA 29 sections
Ciprofloxacin HUMAN PRESCRIPTION DRUG LABEL 1 0172-5313 TABLET, FILM COATED 750 mg ORAL ANDA 29 sections
OTIPRIO HUMAN PRESCRIPTION DRUG LABEL 1 0268-8200 SUSPENSION 60 mg INTRATYMPANIC NDA 26 sections
Ciprofloxacin HUMAN PRESCRIPTION DRUG LABEL 1 0404-7187 SOLUTION/ DROPS 3 mg OPHTHALMIC ANDA 24 sections
CIPROFLOXACIN HUMAN PRESCRIPTION DRUG LABEL 1 0409-4777 INJECTION, SOLUTION 2 mg INTRAVENOUS ANDA 34 sections
Ciprofloxacin HUMAN PRESCRIPTION DRUG LABEL 1 0615-8147 TABLET, FILM COATED 500 mg ORAL ANDA 29 sections
Ciprofloxacin HUMAN PRESCRIPTION DRUG LABEL 1 0615-8367 TABLET, FILM COATED 500 mg ORAL ANDA 31 sections
Ciprofloxacin HUMAN PRESCRIPTION DRUG LABEL 1 0615-8367 TABLET, FILM COATED 500 mg ORAL ANDA 31 sections
Ciprofloxacin and Dexamethasone HUMAN PRESCRIPTION DRUG LABEL 2 0781-6186 SUSPENSION/ DROPS 3 mg AURICULAR (OTIC) NDA authorized generic 27 sections
Ciprofloxacin HUMAN PRESCRIPTION DRUG LABEL 1 0904-6378 TABLET, FILM COATED 500 mg ORAL ANDA 28 sections
Ciprofloxacin HUMAN PRESCRIPTION DRUG LABEL 1 0904-6378 TABLET, FILM COATED 500 mg ORAL ANDA 28 sections
Ciprofloxacin HUMAN PRESCRIPTION DRUG LABEL 1 0904-7083 TABLET, FILM COATED 500 mg ORAL ANDA 30 sections
Ciprofloxacin HUMAN PRESCRIPTION DRUG LABEL 1 10544-036 TABLET, FILM COATED 500 mg ORAL ANDA 29 sections
ciprofloxacin HUMAN PRESCRIPTION DRUG LABEL 1 10544-079 TABLET 500 mg ORAL ANDA 27 sections
Ciprofloxacin HUMAN PRESCRIPTION DRUG LABEL 1 10544-147 TABLET, FILM COATED 250 mg ORAL ANDA 27 sections
Ciprofloxacin HUMAN PRESCRIPTION DRUG LABEL 1 10544-432 TABLET, FILM COATED 500 mg ORAL ANDA 29 sections
Ciprofloxacin HUMAN PRESCRIPTION DRUG LABEL 1 10544-603 TABLET 250 mg ORAL ANDA 27 sections
CIPROFLOXACIN HUMAN PRESCRIPTION DRUG LABEL 1 10544-604 TABLET, FILM COATED 250 mg ORAL ANDA 28 sections