ciprofloxacin 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: -0.73
  • 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 5612.31 24.93 1665 6989 44978 2304453
Tendonitis 1067.32 24.93 243 8411 1984 2347447
Abortion spontaneous 1038.91 24.93 349 8305 13096 2336335
Drug interaction 893.50 24.93 385 8269 28778 2320653
Rash 815.37 24.93 453 8201 59105 2290326
Acute kidney injury 775.57 24.93 345 8309 27777 2321654
Tendon pain 742.63 24.93 146 8508 517 2348914
Arthralgia 704.27 24.93 399 8255 53886 2295545
Diarrhoea 673.51 24.93 453 8201 83111 2266320
Nausea 609.88 24.93 479 8175 111710 2237721
Toxic epidermal necrolysis 604.01 24.93 165 8489 2979 2346452
Tendon rupture 601.11 24.93 142 8512 1376 2348055
Pruritus 484.92 24.93 290 8364 43050 2306381
Drug reaction with eosinophilia and systemic symptoms 467.68 24.93 154 8500 5364 2344067
Myalgia 464.55 24.93 229 8425 23104 2326327
Vomiting 451.58 24.93 335 8319 71267 2278164
Pain in extremity 443.14 24.93 272 8382 42268 2307163
Paraesthesia 434.31 24.93 215 8439 21873 2327558
Neuropathy peripheral 425.70 24.93 174 8480 11258 2338173
Hypoaesthesia 377.25 24.93 190 8464 20025 2329406
Dizziness 365.89 24.93 273 8381 58392 2291039
Clostridium difficile colitis 347.96 24.93 98 8556 1981 2347450
Anxiety 344.72 24.93 203 8451 29156 2320275
Pain 333.40 24.93 264 8390 61593 2287838
Stevens-Johnson syndrome 333.33 24.93 112 8542 4147 2345284
Pyrexia 332.61 24.93 249 8405 53459 2295972
Fatigue 331.94 24.93 301 8353 84572 2264859
Tendon disorder 331.58 24.93 78 8576 738 2348693
Urticaria 330.86 24.93 185 8469 24076 2325355
Asthenia 327.71 24.93 234 8420 46692 2302739
Erythema 321.89 24.93 184 8470 24975 2324456
Muscular weakness 295.34 24.93 146 8508 14751 2334680
Tubulointerstitial nephritis 293.48 24.93 89 8565 2349 2347082
Dyspnoea 291.54 24.93 271 8383 78462 2270969
Drug ineffective 278.79 24.93 297 8357 101327 2248104
Abdominal pain 278.59 24.93 188 8466 34186 2315245
Maternal exposure during pregnancy 277.90 24.93 140 8514 14723 2334708
Pathogen resistance 277.55 24.93 68 8586 775 2348656
Gait disturbance 269.93 24.93 158 8496 22387 2327044
Exposure during pregnancy 261.17 24.93 161 8493 25058 2324373
Palpitations 258.77 24.93 138 8516 16318 2333113
Confusional state 258.69 24.93 158 8496 24186 2325245
Clostridium difficile infection 258.12 24.93 84 8570 2806 2346625
Hypersensitivity 252.92 24.93 154 8500 23439 2325992
Blister 251.54 24.93 103 8551 6668 2342763
Malaise 244.27 24.93 211 8443 55374 2294057
Disturbance in attention 240.61 24.93 95 8559 5590 2343841
Headache 236.75 24.93 244 8410 79935 2269496
Urinary tract infection 235.89 24.93 161 8493 29781 2319650
Burning sensation 224.13 24.93 99 8555 7729 2341702
Panic attack 210.02 24.93 78 8576 3878 2345553
Depression 204.44 24.93 144 8510 27988 2321443
Condition aggravated 194.54 24.93 147 8507 31832 2317599
Electrocardiogram QT prolonged 192.51 24.93 89 8565 7725 2341706
Tremor 186.46 24.93 121 8533 20540 2328891
Drug-induced liver injury 185.65 24.93 70 8584 3629 2345802
Multiple organ dysfunction syndrome 185.03 24.93 86 8568 7555 2341876
Toxicity to various agents 176.19 24.93 140 8514 32614 2316817
Back pain 176.06 24.93 138 8516 31521 2317910
Insomnia 173.51 24.93 126 8528 25661 2323770
Decreased appetite 171.67 24.93 131 8523 28760 2320671
Torsade de pointes 171.41 24.93 58 8596 2188 2347243
Drug resistance 170.18 24.93 60 8594 2564 2346867
Tinnitus 166.72 24.93 71 8583 5064 2344367
Hallucination 164.67 24.93 81 8573 8067 2341364
Anaphylactic reaction 162.64 24.93 85 8569 9620 2339811
Blood creatinine increased 161.67 24.93 87 8567 10446 2338985
Acute hepatic failure 158.42 24.93 57 8597 2585 2346846
Visual impairment 152.73 24.93 87 8567 11668 2337763
Restlessness 151.14 24.93 64 8590 4499 2344932
Abdominal pain upper 150.93 24.93 109 8545 21991 2327440
Swelling 150.51 24.93 97 8557 16253 2333178
Rash maculo-papular 148.74 24.93 62 8592 4190 2345241
Joint swelling 140.72 24.93 94 8560 16725 2332706
Muscle spasms 139.62 24.93 103 8551 21463 2327968
Tachycardia 137.98 24.93 92 8562 16317 2333114
Abdominal discomfort 132.82 24.93 92 8562 17364 2332067
Musculoskeletal stiffness 131.15 24.93 80 8574 12167 2337264
Somnolence 129.64 24.93 102 8552 23383 2326048
Pseudomembranous colitis 129.48 24.93 34 8620 520 2348911
Seizure 128.08 24.93 103 8551 24363 2325068
Dermatitis exfoliative 126.88 24.93 40 8614 1201 2348230
Drug eruption 125.80 24.93 51 8603 3208 2346223
Chest pain 125.58 24.93 108 8546 28029 2321402
Nervous system disorder 124.55 24.93 50 8604 3066 2346365
Neck pain 122.07 24.93 65 8589 7632 2341799
Hypotension 120.03 24.93 112 8542 32324 2317107
Musculoskeletal pain 119.18 24.93 72 8582 10758 2338673
Sepsis 118.96 24.93 88 8566 18400 2331031
Nerve injury 118.65 24.93 37 8617 1071 2348360
Oedema peripheral 117.96 24.93 97 8557 23666 2325765
Muscle twitching 116.18 24.93 46 8608 2719 2346712
Impaired work ability 115.87 24.93 41 8613 1769 2347662
Dermatitis bullous 115.37 24.93 39 8615 1465 2347966
Chills 113.69 24.93 80 8574 15472 2333959
Neuralgia 111.81 24.93 45 8609 2777 2346654
Septic shock 110.25 24.93 59 8595 6995 2342436
Musculoskeletal injury 110.16 24.93 19 8635 23 2349408
Liver injury 109.62 24.93 42 8612 2272 2347159
Rash erythematous 107.72 24.93 55 8599 5921 2343510
Weight decreased 105 24.93 98 8556 28273 2321158
Acute generalised exanthematous pustulosis 104.02 24.93 37 8617 1621 2347810
General physical health deterioration 103.96 24.93 73 8581 14066 2335365
Pancytopenia 103.01 24.93 67 8587 11385 2338046
Muscle atrophy 102.93 24.93 33 8621 1047 2348384
Tendon injury 102.79 24.93 25 8629 275 2349156
Hepatitis 101.84 24.93 54 8600 6283 2343148
Renal failure 101.44 24.93 78 8576 17271 2332160
Sleep disorder 100.64 24.93 54 8600 6435 2342996
Inflammation 100.00 24.93 53 8601 6160 2343271
International normalised ratio increased 99.84 24.93 56 8598 7280 2342151
Dysphagia 98.56 24.93 68 8586 12737 2336694
Tenosynovitis 98.55 24.93 27 8627 489 2348942
Loss of consciousness 98.14 24.93 79 8575 18688 2330743
Polyneuropathy 98.08 24.93 36 8618 1727 2347704
Joint noise 97.94 24.93 28 8626 596 2348835
Treatment failure 97.81 24.93 55 8599 7184 2342247
Food intolerance 97.31 24.93 25 8629 349 2349082
Swelling face 96.48 24.93 60 8594 9433 2339998
Feeling abnormal 96.11 24.93 86 8568 23495 2325936
Disorientation 95.95 24.93 52 8602 6320 2343111
Renal impairment 95.59 24.93 61 8593 10031 2339400
Pneumonia 95.56 24.93 121 8533 49175 2300256
Renal tubular necrosis 94.16 24.93 34 8620 1556 2347875
Weight bearing difficulty 94.03 24.93 25 8629 402 2349029
Myoclonus 92.89 24.93 38 8616 2445 2346986
Thrombocytopenia 92.62 24.93 77 8577 19054 2330377
Hyperhidrosis 91.60 24.93 70 8584 15352 2334079
Thinking abnormal 91.10 24.93 35 8619 1907 2347524
Delirium 91.04 24.93 47 8607 5176 2344255
Haematochezia 90.43 24.93 47 8607 5248 2344183
Syncope 90.28 24.93 72 8582 16803 2332628
Vision blurred 90.26 24.93 68 8586 14600 2334831
Dehydration 90.24 24.93 81 8573 22214 2327217
Cholestatic liver injury 89.72 24.93 22 8632 251 2349180
Electrolyte imbalance 89.47 24.93 35 8619 2002 2347429
Contusion 89.22 24.93 64 8590 12746 2336685
Ear pain 89.16 24.93 38 8616 2711 2346720
Rhabdomyolysis 88.04 24.93 50 8604 6654 2342777
Arrhythmia 87.45 24.93 48 8606 5980 2343451
Gait inability 85.24 24.93 47 8607 5908 2343523
Inappropriate antidiuretic hormone secretion 85.23 24.93 35 8619 2274 2347157
Dysbiosis 84.32 24.93 16 8638 44 2349387
Oliguria 84.05 24.93 30 8624 1327 2348104
Respiratory failure 83.86 24.93 63 8591 13465 2335966
Overdose 81.89 24.93 73 8581 19834 2329597
Generalised tonic-clonic seizure 81.32 24.93 44 8610 5328 2344103
Jaundice 80.29 24.93 44 8610 5464 2343967
Rash macular 80.04 24.93 38 8616 3493 2345938
Gastrointestinal disorder 79.76 24.93 52 8602 8865 2340566
Rotator cuff syndrome 78.90 24.93 31 8623 1794 2347637
Photophobia 78.75 24.93 33 8621 2256 2347175
Idiopathic intracranial hypertension 78.31 24.93 23 8631 540 2348891
Cholestasis 78.14 24.93 38 8616 3683 2345748
Diverticulitis 76.99 24.93 39 8615 4126 2345305
Epilepsy 75.85 24.93 40 8614 4599 2344832
Oedema 75.72 24.93 53 8601 10150 2339281
C-reactive protein increased 75.07 24.93 44 8610 6211 2343220
Candida infection 74.69 24.93 34 8620 2839 2346592
Aspartate aminotransferase increased 74.34 24.93 57 8597 12555 2336876
Mental disorder 72.55 24.93 37 8617 3970 2345461
Hepatic encephalopathy 71.95 24.93 28 8626 1579 2347852
Lip swelling 71.62 24.93 39 8615 4782 2344649
Alanine aminotransferase increased 71.07 24.93 58 8596 13974 2335457
Abdominal pain lower 70.90 24.93 33 8621 2900 2346531
Leukocytosis 70.55 24.93 35 8619 3541 2345890
Photosensitivity reaction 70.36 24.93 31 8623 2396 2347035
Respiratory disorder 69.68 24.93 36 8618 3968 2345463
Skin injury 69.30 24.93 18 8636 263 2349168
Skin warm 69.28 24.93 22 8632 676 2348755
Long QT syndrome 69.25 24.93 21 8633 552 2348879
Irritable bowel syndrome 68.26 24.93 28 8626 1813 2347618
Hyperthyroidism 68.04 24.93 29 8625 2068 2347363
Swollen tongue 67.87 24.93 39 8615 5304 2344127
Mouth ulceration 67.58 24.93 35 8619 3877 2345554
Connective tissue disorder 67.50 24.93 17 8637 218 2349213
Status epilepticus 66.55 24.93 30 8624 2448 2346983
Colitis 65.99 24.93 38 8616 5188 2344243
Linear IgA disease 65.18 24.93 18 8636 336 2349095
Suicidal ideation 65.10 24.93 50 8604 11037 2338394
Pleural effusion 64.99 24.93 51 8603 11617 2337814
Rash papular 64.69 24.93 30 8624 2614 2346817
Memory impairment 64.57 24.93 53 8601 12870 2336561
Alopecia 64.57 24.93 67 8587 21934 2327497
Haematoma 64.03 24.93 37 8617 5084 2344347
Nightmare 63.64 24.93 33 8621 3664 2345767
Circulatory collapse 63.45 24.93 33 8621 3687 2345744
Gastrointestinal pain 63.06 24.93 23 8631 1083 2348348
Eye pain 62.92 24.93 36 8618 4855 2344576
Ligament rupture 62.81 24.93 19 8635 495 2348936
Cough 62.04 24.93 80 8574 33037 2316394
Tendon discomfort 61.74 24.93 12 8642 39 2349392
Sensory disturbance 61.72 24.93 29 8625 2603 2346828
Cardiovascular disorder 61.63 24.93 28 8626 2327 2347104
Eye swelling 61.04 24.93 34 8620 4356 2345075
Mental impairment 60.68 24.93 28 8626 2412 2347019
Blood alkaline phosphatase increased 60.56 24.93 39 8615 6506 2342925
Aspergillus infection 58.54 24.93 21 8633 942 2348489
Hypoglycaemia 58.51 24.93 42 8612 8365 2341066
Acute respiratory distress syndrome 58.44 24.93 30 8624 3262 2346169
Pseudomonas infection 58.23 24.93 22 8632 1144 2348287
Completed suicide 58.05 24.93 62 8592 20972 2328459
Loss of personal independence in daily activities 57.58 24.93 35 8619 5276 2344155
Skin exfoliation 57.30 24.93 36 8618 5754 2343677
Crystal nephropathy 56.96 24.93 12 8642 64 2349367
Orthostatic hypotension 56.26 24.93 28 8626 2851 2346580
Product use in unapproved indication 56.08 24.93 46 8608 11154 2338277
Hypertension 55.85 24.93 69 8585 27292 2322139
Paranoia 54.97 24.93 25 8629 2082 2347349
Blood bilirubin increased 54.83 24.93 34 8620 5311 2344120
Mobility decreased 54.51 24.93 41 8613 8769 2340662
Potentiating drug interaction 54.33 24.93 18 8636 634 2348797
Arthritis 54.28 24.93 43 8611 9925 2339506
Nephropathy toxic 54.25 24.93 21 8633 1167 2348264
Klebsiella infection 54.16 24.93 19 8635 798 2348633
Wheezing 54.09 24.93 36 8618 6348 2343083
Drug intolerance 53.81 24.93 49 8605 13668 2335763
Muscle contractions involuntary 53.76 24.93 17 8637 515 2348916
Sjogren's syndrome 53.66 24.93 20 8634 1001 2348430
Skin burning sensation 53.54 24.93 24 8630 1932 2347499
Balance disorder 52.97 24.93 42 8612 9705 2339726
Vasculitis 52.69 24.93 25 8629 2293 2347138
Activated partial thromboplastin time prolonged 52.65 24.93 21 8633 1264 2348167
Hepatocellular injury 52.57 24.93 30 8624 4025 2345406
Multiple chemical sensitivity 52.13 24.93 9 8645 11 2349420
Groin pain 51.64 24.93 21 8633 1329 2348102
Factor V deficiency 51.10 24.93 10 8644 34 2349397
Pulmonary eosinophilia 51.02 24.93 12 8642 113 2349318
Emotional distress 50.97 24.93 30 8624 4265 2345166
Muscle tightness 50.95 24.93 23 8631 1882 2347549
Ear discomfort 50.85 24.93 20 8634 1160 2348271
Renal injury 50.84 24.93 19 8635 958 2348473
Tachypnoea 50.54 24.93 24 8630 2205 2347226
Hepatic failure 50.42 24.93 33 8621 5656 2343775
Agitation 50.39 24.93 43 8611 11008 2338423
Crohn's disease 50.37 24.93 35 8619 6620 2342811
Fibromyalgia 49.85 24.93 27 8627 3273 2346158
Atrial fibrillation 49.78 24.93 47 8607 13721 2335710
Abdominal tenderness 49.56 24.93 19 8635 1028 2348403
Infection 49.49 24.93 53 8601 17976 2331455
Megacolon 49.46 24.93 14 8640 287 2349144
Escherichia urinary tract infection 49.21 24.93 20 8634 1264 2348167
Haemoglobin decreased 49.19 24.93 53 8601 18098 2331333
Flank pain 48.91 24.93 21 8633 1524 2347907
Neurotoxicity 48.50 24.93 23 8631 2107 2347324
Abdominal distension 48.47 24.93 41 8613 10370 2339061
Heart rate increased 48.18 24.93 42 8612 11063 2338368
Haemolytic anaemia 48.07 24.93 22 8632 1859 2347572
Face oedema 47.96 24.93 28 8626 3920 2345511
Dyskinesia 47.95 24.93 30 8624 4759 2344672
Multiple-drug resistance 47.83 24.93 13 8641 228 2349203
Tenderness 47.66 24.93 22 8632 1896 2347535
Amnesia 47.66 24.93 35 8619 7218 2342213
Cholecystitis 47.40 24.93 23 8631 2217 2347214
Peripheral swelling 47.02 24.93 51 8603 17546 2331885
Eosinophilia 46.82 24.93 25 8629 2945 2346486
Chronic fatigue syndrome 46.74 24.93 12 8642 167 2349264
Liver function test abnormal 46.65 24.93 35 8619 7455 2341976
Fixed eruption 46.15 24.93 12 8642 176 2349255
Ectropion 45.78 24.93 10 8644 65 2349366
Anaemia 45.78 24.93 71 8583 34721 2314710
Dry skin 45.75 24.93 33 8621 6619 2342812
Osteochondrosis 45.72 24.93 12 8642 183 2349248
Dysuria 45.38 24.93 27 8627 3914 2345517
Interstitial lung disease 45.34 24.93 35 8619 7777 2341654
Factor V inhibition 45.25 24.93 9 8645 34 2349397
Cyanosis 45.18 24.93 25 8629 3160 2346271
Leukopenia 45.11 24.93 39 8615 10157 2339274
Inflammatory marker increased 44.47 24.93 15 8639 559 2348872
Encephalopathy 44.23 24.93 28 8626 4533 2344898
Toxic skin eruption 44.22 24.93 22 8632 2238 2347193
Frequent bowel movements 44.18 24.93 21 8633 1933 2347498
Exfoliative rash 43.99 24.93 14 8640 433 2348998
Eyelid oedema 43.93 24.93 23 8631 2603 2346828
Hypersensitivity pneumonitis 43.93 24.93 14 8640 435 2348996
Migraine 43.63 24.93 39 8615 10614 2338817
Psychotic disorder 43.57 24.93 28 8626 4651 2344780
Off label use 43.45 24.93 107 8547 73491 2275940
Deafness 43.32 24.93 23 8631 2678 2346753
Blood creatine increased 42.69 24.93 15 8639 633 2348798
Staphylococcal infection 42.64 24.93 29 8625 5297 2344134
Cognitive disorder 42.37 24.93 29 8625 5352 2344079
Osteoarthritis 42.24 24.93 32 8622 6914 2342517
Dysaesthesia 42.22 24.93 15 8639 654 2348777
Metabolic acidosis 41.81 24.93 30 8624 5968 2343463
Moraxella test positive 41.80 24.93 7 8647 6 2349425
Myositis 41.78 24.93 18 8636 1317 2348114
Epicondylitis 41.72 24.93 12 8642 261 2349170
Constipation 41.65 24.93 53 8601 21576 2327855
Hyponatraemia 41.64 24.93 42 8612 13283 2336148
Escherichia infection 41.61 24.93 18 8636 1330 2348101
Mental status changes 41.40 24.93 29 8625 5553 2343878
Hyperacusis 41.04 24.93 13 8641 396 2349035
Angioedema 41.01 24.93 34 8620 8362 2341069
Depressed mood 40.89 24.93 28 8626 5170 2344261
Retinal detachment 40.84 24.93 17 8637 1142 2348289
Type IV hypersensitivity reaction 40.49 24.93 14 8640 563 2348868
Bronchiectasis 40.40 24.93 16 8638 945 2348486
Clostridium test positive 40.33 24.93 12 8642 295 2349136
Chest discomfort 40.21 24.93 43 8611 14552 2334879
Vitreous floaters 40.11 24.93 16 8638 963 2348468
Serotonin syndrome 40.10 24.93 24 8630 3516 2345915
Liver disorder 40.00 24.93 30 8624 6384 2343047
Systemic inflammatory response syndrome 39.95 24.93 15 8639 766 2348665
Rash pruritic 39.93 24.93 32 8622 7503 2341928
Aphasia 39.84 24.93 27 8627 4901 2344530
Injury 39.72 24.93 29 8625 5925 2343506
Acute febrile neutrophilic dermatosis 39.65 24.93 13 8641 443 2348988
Device related infection 39.29 24.93 23 8631 3236 2346195
Transaminases increased 39.17 24.93 26 8628 4561 2344870
Appetite disorder 39.13 24.93 14 8640 623 2348808
Exercise tolerance decreased 38.88 24.93 14 8640 635 2348796
Dysgeusia 38.73 24.93 33 8621 8426 2341005
Lymphadenopathy 38.57 24.93 28 8626 5670 2343761
Depersonalisation/derealisation disorder 38.12 24.93 11 8643 242 2349189
Feeling hot 37.95 24.93 30 8624 6898 2342533
Therapeutic product cross-reactivity 37.87 24.93 12 8642 366 2349065
Pouchitis 37.68 24.93 9 8645 91 2349340
Faeces discoloured 37.59 24.93 20 8634 2339 2347092
Gastroenteritis pseudomonas 37.11 24.93 6 8648 3 2349428
Gamma-glutamyltransferase increased 36.90 24.93 27 8627 5535 2343896
Physical disability 36.70 24.93 10 8644 177 2349254
Enterovesical fistula 36.59 24.93 9 8645 104 2349327
Cystitis 36.55 24.93 27 8627 5615 2343816
Musculoskeletal discomfort 36.55 24.93 19 8635 2119 2347312
Meningitis candida 36.48 24.93 6 8648 4 2349427
Erythema multiforme 36.24 24.93 19 8635 2156 2347275
Skin toxicity 36.19 24.93 14 8640 776 2348655
Clostridial infection 35.96 24.93 14 8640 790 2348641
Diabetic macroangiopathy 35.90 24.93 6 8648 5 2349426
Hormone level abnormal 35.78 24.93 12 8642 439 2348992
Bladder pain 35.74 24.93 11 8643 304 2349127
Adverse reaction 35.74 24.93 17 8637 1567 2347864
Hypersensitivity vasculitis 35.71 24.93 16 8638 1286 2348145
Contraindicated product administered 35.57 24.93 21 8633 3000 2346431
White blood cell count increased 35.27 24.93 29 8625 7049 2342382
Lip oedema 35.18 24.93 14 8640 837 2348594
Burnout syndrome 35.17 24.93 8 8646 64 2349367
Throat tightness 35.14 24.93 24 8630 4412 2345019
Prothrombin time prolonged 34.82 24.93 17 8637 1660 2347771
Feeling cold 34.76 24.93 21 8633 3129 2346302
Loss of employment 34.68 24.93 9 8645 131 2349300
Renal pain 34.59 24.93 14 8640 875 2348556
Drug level increased 34.47 24.93 20 8634 2767 2346664
Arthropathy 34.43 24.93 29 8625 7287 2342144
Muscle rupture 34.42 24.93 11 8643 345 2349086
Bacteraemia 34.32 24.93 17 8637 1713 2347718
Walking disability 34.24 24.93 10 8644 230 2349201
Vertigo 33.84 24.93 32 8622 9352 2340079
Coagulopathy 33.67 24.93 20 8634 2889 2346542
Intestinal dilatation 33.56 24.93 10 8644 247 2349184
Peripheral nerve injury 33.40 24.93 8 8646 82 2349349
Dystonia 33.27 24.93 18 8636 2176 2347255
Myopathy 33.12 24.93 16 8638 1527 2347904
Bacterial infection 33.07 24.93 18 8636 2203 2347228
Hepatotoxicity 32.83 24.93 21 8633 3460 2345971
Agranulocytosis 32.82 24.93 21 8633 3461 2345970
Norovirus test positive 32.67 24.93 7 8647 41 2349390
Dyspepsia 32.55 24.93 32 8622 9812 2339619
Thrombotic thrombocytopenic purpura 32.53 24.93 13 8641 786 2348645
Hypertensive heart disease 32.53 24.93 11 8643 413 2349018
Joint stiffness 32.42 24.93 22 8632 4001 2345430
Skin lesion 32.41 24.93 22 8632 4003 2345428
Foreign body aspiration 32.33 24.93 8 8646 95 2349336
Blood urea increased 32.16 24.93 21 8633 3584 2345847
Non-consummation 32.04 24.93 5 8649 1 2349430
Infusion site erythema 31.96 24.93 13 8641 823 2348608
Diarrhoea haemorrhagic 31.79 24.93 15 8639 1358 2348073
Catatonia 31.75 24.93 13 8641 837 2348594
Meniscus injury 31.74 24.93 14 8640 1084 2348347
Gastric disorder 31.61 24.93 21 8633 3689 2345742
Cholelithiasis 31.51 24.93 25 8629 5778 2343653
Abnormal behaviour 31.33 24.93 23 8631 4737 2344694
Anorectal ulcer 31.27 24.93 5 8649 2 2349429
Immune system disorder 31.25 24.93 15 8639 1411 2348020
Hepatitis cholestatic 31.04 24.93 14 8640 1143 2348288
Complex regional pain syndrome 31.04 24.93 10 8644 322 2349109
Haematuria 31.02 24.93 22 8632 4296 2345135
Abnormal palmar/plantar creases 30.99 24.93 6 8648 19 2349412
Fear of death 30.94 24.93 9 8645 204 2349227
Dysstasia 30.91 24.93 19 8635 2920 2346511
Pyelonephritis 30.90 24.93 17 8637 2124 2347307
Hepatic enzyme increased 30.81 24.93 31 8623 9771 2339660
Diplopia 30.46 24.93 20 8634 3445 2345986
Paralysis 30.42 24.93 16 8638 1828 2347603
Fear 30.32 24.93 18 8636 2598 2346833
Night sweats 30.27 24.93 20 8634 3480 2345951
Amenorrhoea 30.19 24.93 17 8637 2222 2347209
Tendon necrosis 30.01 24.93 5 8649 4 2349427
Seroconversion test positive 30.01 24.93 5 8649 4 2349427
Haemorrhagic diathesis 29.89 24.93 11 8643 531 2348900
Haematemesis 29.79 24.93 21 8633 4061 2345370
Dysarthria 29.70 24.93 25 8629 6277 2343154
Skin disorder 29.60 24.93 20 8634 3611 2345820
Osteomyelitis 29.59 24.93 20 8634 3613 2345818
Thyroxine free decreased 29.56 24.93 7 8647 68 2349363
Periorbital oedema 29.49 24.93 13 8641 1005 2348426
Chromaturia 29.47 24.93 18 8636 2735 2346696
Urosepsis 29.34 24.93 16 8638 1965 2347466
Adverse event 29.32 24.93 27 8627 7632 2341799
Speech disorder 29.14 24.93 25 8629 6439 2342992
Gastrooesophageal reflux disease 29.02 24.93 29 8625 9066 2340365
Peripheral coldness 28.94 24.93 15 8639 1662 2347769
Proteinuria 28.89 24.93 18 8636 2832 2346599
Conjunctival hyperaemia 28.75 24.93 11 8643 592 2348839
C-reactive protein decreased 28.53 24.93 7 8647 80 2349351
Hypotonia 28.50 24.93 15 8639 1715 2347716
Crying 28.39 24.93 21 8633 4375 2345056
Neutropenia 28.35 24.93 44 8610 21504 2327927
Arthritis infective 27.96 24.93 11 8643 638 2348793
No adverse event 27.89 24.93 29 8625 9499 2339932
Mast cell activation syndrome 27.88 24.93 6 8648 36 2349395
Trimethylaminuria 27.81 24.93 5 8649 9 2349422
Haemorrhage 27.75 24.93 31 8623 11008 2338423
Bone marrow failure 27.71 24.93 23 8631 5663 2343768
Respiratory distress 27.64 24.93 22 8632 5107 2344324
Gastroenteritis clostridial 27.63 24.93 7 8647 92 2349339
Dry mouth 27.60 24.93 27 8627 8226 2341205
Discomfort 27.53 24.93 22 8632 5137 2344294
Impaired quality of life 27.39 24.93 8 8646 184 2349247
Ballismus 27.21 24.93 6 8648 41 2349390
Mixed liver injury 27.11 24.93 9 8645 319 2349112
Blood potassium decreased 26.98 24.93 22 8632 5283 2344148
Productive cough 26.93 24.93 22 8632 5299 2344132
Cellulitis 26.92 24.93 28 8626 9173 2340258
Malacoplakia gastrointestinal 26.84 24.93 5 8649 12 2349419
Acid base balance abnormal 26.72 24.93 6 8648 45 2349386
Diaphragmatic rupture 26.55 24.93 5 8649 13 2349418
Quality of life decreased 26.38 24.93 11 8643 742 2348689
Joint injury 26.33 24.93 16 8638 2408 2347023
Cardiac arrest 26.26 24.93 35 8619 14895 2334536
Limb discomfort 26.10 24.93 18 8636 3361 2346070
Oral pain 26.01 24.93 18 8636 3379 2346052
Haemodialysis 25.99 24.93 15 8639 2054 2347377
Ataxia 25.92 24.93 16 8638 2476 2346955
Hypoacusis 25.88 24.93 18 8636 3407 2346024
Drug ineffective for unapproved indication 25.78 24.93 17 8637 2949 2346482
Nikolsky's sign 25.69 24.93 7 8647 124 2349307
Parosmia 25.67 24.93 11 8643 794 2348637
Hypophagia 25.59 24.93 19 8635 3981 2345450
Hepatitis infectious mononucleosis 25.55 24.93 5 8649 17 2349414
Faecal volume decreased 25.55 24.93 5 8649 17 2349414
Blood creatine phosphokinase increased 25.50 24.93 21 8633 5115 2344316
Segmental diverticular colitis 25.47 24.93 4 8650 1 2349430
Skin ulcer 25.34 24.93 19 8635 4040 2345391
Pain of skin 25.13 24.93 13 8641 1435 2347996
Purpura 25.10 24.93 14 8640 1796 2347635
Bradycardia 25.04 24.93 28 8626 9953 2339478
Fungaemia 25.03 24.93 8 8646 251 2349180

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
Tendonitis 959.58 28.80 214 6334 1219 1739014
Tendon rupture 851.30 28.80 202 6346 1570 1738663
Drug hypersensitivity 798.51 28.80 314 6234 14821 1725412
Tendon pain 725.81 28.80 142 6406 362 1739871
Acute kidney injury 706.71 28.80 371 6177 34573 1705660
Drug interaction 681.63 28.80 337 6211 27621 1712612
Arthralgia 635.30 28.80 304 6244 23140 1717093
Rash 481.99 28.80 300 6248 38393 1701840
Drug ineffective 475.88 28.80 360 6188 63441 1676792
Tendon disorder 399.78 28.80 87 6461 429 1739804
Myalgia 395.50 28.80 194 6354 15464 1724769
Pain in extremity 393.80 28.80 204 6344 18268 1721965
Pyrexia 374.15 28.80 275 6273 46125 1694108
Diarrhoea 365.68 28.80 288 6260 53564 1686669
Toxic epidermal necrolysis 364.79 28.80 110 6438 2261 1737972
Paraesthesia 364.57 28.80 162 6386 10289 1729944
Pruritus 334.17 28.80 198 6350 23024 1717209
Clostridium difficile colitis 333.31 28.80 94 6454 1510 1738723
Neuropathy peripheral 330.89 28.80 146 6402 9107 1731126
Pathogen resistance 320.65 28.80 84 6464 1005 1739228
Anxiety 312.08 28.80 165 6383 15362 1724871
Drug resistance 311.42 28.80 105 6443 3125 1737108
Tinnitus 281.14 28.80 97 6451 3098 1737135
Condition aggravated 267.10 28.80 166 6382 20984 1719249
Vomiting 263.66 28.80 207 6341 38108 1702125
Nausea 262.14 28.80 233 6315 50963 1689270
Drug reaction with eosinophilia and systemic symptoms 261.73 28.80 104 6444 4966 1735267
Septic shock 261.19 28.80 119 6429 7990 1732243
Pain 250.76 28.80 174 6374 26483 1713750
Fatigue 238.01 28.80 220 6328 50561 1689672
Stevens-Johnson syndrome 234.91 28.80 86 6462 3271 1736962
Erythema 230.21 28.80 131 6417 14057 1726176
Hypoaesthesia 221.65 28.80 113 6435 9722 1730511
Multiple organ dysfunction syndrome 216.47 28.80 109 6439 9133 1731100
Depression 208.10 28.80 130 6418 16539 1723694
Tubulointerstitial nephritis 207.75 28.80 76 6472 2882 1737351
Asthenia 201.65 28.80 170 6378 34500 1705733
Palpitations 200.59 28.80 94 6454 6720 1733513
Headache 198.77 28.80 168 6380 34208 1706025
Muscular weakness 188.97 28.80 103 6445 10146 1730087
Burning sensation 183.17 28.80 71 6477 3164 1737069
Dizziness 180.49 28.80 159 6389 34202 1706031
Abdominal pain 180.36 28.80 131 6417 21359 1718874
International normalised ratio increased 180.10 28.80 93 6455 8206 1732027
Tremor 178.03 28.80 108 6440 13023 1727210
Confusional state 174.68 28.80 128 6420 21150 1719083
Urticaria 174.53 28.80 104 6444 12137 1728096
Gait disturbance 173.80 28.80 105 6443 12565 1727668
Muscle twitching 171.26 28.80 58 6490 1744 1738489
Thrombocytopenia 168.06 28.80 125 6423 21124 1719109
Insomnia 163.94 28.80 111 6437 16165 1724068
Clostridium difficile infection 152.40 28.80 53 6495 1728 1738505
Malaise 151.50 28.80 135 6413 29430 1710803
Renal tubular necrosis 150.81 28.80 55 6493 2064 1738169
Hypersensitivity 149.52 28.80 89 6459 10355 1729878
Renal failure 145.49 28.80 112 6436 19905 1720328
Urinary tract infection 143.98 28.80 86 6462 10067 1730166
Torsade de pointes 143.26 28.80 47 6501 1277 1738956
Panic attack 142.77 28.80 51 6497 1801 1738432
Acute generalised exanthematous pustulosis 142.55 28.80 45 6503 1077 1739156
Sleep disorder 141.35 28.80 63 6485 4000 1736233
Dehydration 139.80 28.80 104 6444 17554 1722679
Sepsis 137.41 28.80 107 6441 19331 1720902
Jaundice 134.52 28.80 69 6479 5993 1734240
Pseudomembranous colitis 133.37 28.80 36 6512 485 1739748
Weight decreased 132.85 28.80 112 6436 22641 1717592
Rhabdomyolysis 131.96 28.80 84 6464 11006 1729227
Muscle spasms 130.82 28.80 85 6463 11536 1728697
Rash erythematous 130.03 28.80 59 6489 3906 1736327
Joint noise 128.77 28.80 29 6519 171 1740062
Pseudomonas infection 127.94 28.80 43 6505 1261 1738972
Decreased appetite 124.16 28.80 110 6438 23761 1716472
Electrocardiogram QT prolonged 122.69 28.80 63 6485 5482 1734751
Hypotension 122.17 28.80 120 6428 29534 1710699
Hallucination 117.86 28.80 70 6478 8100 1732133
Dyspnoea 117.52 28.80 154 6394 51905 1688328
Musculoskeletal pain 116.18 28.80 59 6489 5015 1735218
Candida infection 114.44 28.80 44 6504 1914 1738319
Neuralgia 113.33 28.80 40 6508 1362 1738871
Cholestasis 109.10 28.80 51 6497 3614 1736619
Anuria 108.82 28.80 42 6506 1846 1738387
Chills 108.80 28.80 76 6472 11611 1728622
Rash maculo-papular 108.60 28.80 51 6497 3652 1736581
Tendon discomfort 107.13 28.80 20 6528 35 1740198
Eye pain 107.00 28.80 44 6504 2287 1737946
Impaired work ability 106.41 28.80 36 6512 1077 1739156
Oedema peripheral 106.36 28.80 84 6464 15466 1724767
Balance disorder 105.85 28.80 58 6490 5754 1734479
Seizure 105.84 28.80 94 6454 20347 1719886
Suicidal ideation 104.98 28.80 66 6482 8452 1731781
Joint swelling 101.03 28.80 58 6490 6295 1733938
Agitation 100.99 28.80 71 6477 10955 1729278
Anaphylactic reaction 100.41 28.80 57 6491 6056 1734177
Prostatitis 98.94 28.80 33 6515 944 1739289
Arrhythmia 98.55 28.80 56 6492 5960 1734273
Nervous system disorder 98.16 28.80 42 6506 2412 1737821
Skin exfoliation 95.91 28.80 50 6498 4485 1735748
Liver function test abnormal 95.68 28.80 54 6494 5672 1734561
Musculoskeletal discomfort 93.96 28.80 32 6516 977 1739256
C-reactive protein increased 91.63 28.80 53 6495 5832 1734401
Vasculitis 90.63 28.80 35 6513 1540 1738693
Photosensitivity reaction 90.52 28.80 36 6512 1714 1738519
Angioedema 90.28 28.80 63 6485 9601 1730632
Musculoskeletal stiffness 89.05 28.80 52 6496 5824 1734409
Blood creatinine increased 88.24 28.80 72 6476 13874 1726359
Swelling 88.18 28.80 55 6493 6941 1733292
Night sweats 87.89 28.80 38 6510 2238 1737995
Drug-induced liver injury 87.02 28.80 42 6506 3195 1737038
Off label use 85.15 28.80 113 6435 38458 1701775
Drug eruption 84.86 28.80 40 6508 2886 1737347
Clostridium test positive 83.82 28.80 22 6526 264 1739969
Visual impairment 83.75 28.80 51 6497 6167 1734066
Respiratory failure 83.70 28.80 71 6477 14434 1725799
Tenosynovitis 83.07 28.80 22 6526 274 1739959
Tendon injury 82.11 28.80 20 6528 173 1740060
Vision blurred 81.22 28.80 56 6492 8367 1731866
Muscle rupture 81.06 28.80 24 6524 459 1739774
Hepatic failure 81.00 28.80 49 6499 5854 1734379
Renal impairment 80.90 28.80 65 6483 12249 1727984
Staphylococcal infection 80.28 28.80 45 6503 4662 1735571
Factor V inhibition 79.97 28.80 16 6532 47 1740186
Thrombotic thrombocytopenic purpura 79.75 28.80 26 6522 691 1739542
Abdominal distension 79.54 28.80 50 6498 6394 1733839
Haematuria 77.01 28.80 52 6496 7508 1732725
Hepatitis 75.47 28.80 44 6504 4911 1735322
Neutropenia 75.24 28.80 74 6474 18186 1722047
Enterococcal infection 73.93 28.80 26 6522 875 1739358
Hyperhidrosis 73.82 28.80 62 6486 12426 1727807
Hepatocellular injury 72.27 28.80 37 6511 3194 1737039
Eosinophilia 72.04 28.80 38 6510 3489 1736744
Anaemia 70.71 28.80 90 6458 29367 1710866
Musculoskeletal injury 70.67 28.80 13 6535 20 1740213
Joint stiffness 70.12 28.80 30 6518 1721 1738512
Linear IgA disease 70.03 28.80 20 6528 335 1739898
Leukopenia 69.35 28.80 51 6497 8429 1731804
Tachycardia 69.14 28.80 60 6488 12568 1727665
Abdominal discomfort 68.43 28.80 52 6496 9029 1731204
Disseminated intravascular coagulation 68.36 28.80 37 6511 3577 1736656
Disturbance in attention 68.21 28.80 39 6509 4195 1736038
Clostridial infection 68.03 28.80 23 6525 686 1739547
Delirium 67.76 28.80 45 6503 6317 1733916
Sensory disturbance 67.64 28.80 27 6521 1297 1738936
Hypoglycaemia 67.32 28.80 50 6498 8388 1731845
Inflammation 67.16 28.80 36 6512 3414 1736819
Toxicity to various agents 66.74 28.80 87 6461 29054 1711179
Abdominal pain upper 65.80 28.80 55 6493 10946 1729287
Plantar fasciitis 65.62 28.80 17 6531 193 1740040
Drug level increased 65.60 28.80 33 6515 2744 1737489
Back pain 64.14 28.80 65 6483 16548 1723685
Muscle atrophy 63.25 28.80 25 6523 1170 1739063
Feeling abnormal 63.04 28.80 54 6494 11112 1729121
Respiratory distress 61.10 28.80 39 6509 5118 1735115
Colitis 60.71 28.80 36 6512 4144 1736089
Agranulocytosis 60.46 28.80 34 6514 3542 1736691
Product use in unapproved indication 60.30 28.80 49 6499 9373 1730860
Rash pruritic 59.90 28.80 36 6512 4246 1735987
Tenderness 59.75 28.80 23 6525 1002 1739231
Dermatitis bullous 59.21 28.80 24 6524 1200 1739033
Generalised tonic-clonic seizure 59.16 28.80 35 6513 4011 1736222
Dysphagia 59.08 28.80 50 6498 10118 1730115
Rotator cuff syndrome 58.40 28.80 22 6526 903 1739330
Therapeutic product cross-reactivity 57.29 28.80 16 6532 246 1739987
Neck pain 56.89 28.80 32 6516 3334 1736899
Lip swelling 56.75 28.80 30 6518 2765 1737468
Vitreous floaters 56.57 28.80 19 6529 555 1739678
Systemic candida 56.14 28.80 17 6531 352 1739881
Drug ineffective for unapproved indication 56.10 28.80 26 6522 1803 1738430
Skin injury 55.97 28.80 15 6533 196 1740037
Hyponatraemia 55.90 28.80 46 6502 8954 1731279
Injury 55.13 28.80 30 6518 2930 1737303
Guillain-Barre syndrome 55.06 28.80 21 6527 892 1739341
Pulmonary oedema 54.71 28.80 40 6508 6546 1733687
Multiple-drug resistance 54.63 28.80 16 6532 294 1739939
Treatment failure 53.92 28.80 34 6514 4367 1735866
Purpura 53.74 28.80 25 6523 1749 1738484
Mental disorder 53.47 28.80 29 6519 2814 1737419
Swelling face 53.34 28.80 34 6514 4449 1735784
Aspergillus infection 53.25 28.80 23 6525 1350 1738883
Hypersensitivity vasculitis 53.13 28.80 22 6526 1162 1739071
Renal injury 52.95 28.80 22 6526 1172 1739061
Alanine aminotransferase increased 52.86 28.80 51 6497 12227 1728006
Chromaturia 52.55 28.80 28 6520 2622 1737611
Bacteraemia 52.35 28.80 25 6523 1855 1738378
Psychotic disorder 52.00 28.80 35 6513 5021 1735212
Arthritis 51.96 28.80 32 6516 3943 1736290
Urosepsis 51.83 28.80 23 6525 1441 1738792
Subacute cutaneous lupus erythematosus 51.41 28.80 13 6535 133 1740100
Serotonin syndrome 51.21 28.80 28 6520 2760 1737473
Blister 51.10 28.80 32 6516 4060 1736173
Ventricular tachycardia 50.73 28.80 31 6517 3767 1736466
Dysbiosis 50.69 28.80 11 6537 53 1740180
Heart rate increased 50.62 28.80 38 6510 6472 1733761
Dermatitis exfoliative 50.41 28.80 23 6525 1538 1738695
Ligament rupture 50.08 28.80 14 6534 216 1740017
Visual acuity reduced 50.06 28.80 31 6517 3857 1736376
Sacroiliitis 49.99 28.80 13 6535 150 1740083
Skin necrosis 49.86 28.80 19 6529 805 1739428
Throat tightness 49.84 28.80 23 6525 1579 1738654
Restlessness 49.50 28.80 32 6516 4289 1735944
Systemic inflammatory response syndrome 49.37 28.80 19 6529 827 1739406
Liver injury 49.30 28.80 24 6524 1858 1738375
Kounis syndrome 49.22 28.80 16 6532 421 1739812
Haemolytic uraemic syndrome 48.86 28.80 16 6532 431 1739802
Corneal opacity 48.78 28.80 13 6535 166 1740067
Aortic valve prolapse 48.38 28.80 8 6540 3 1740230
Nosocomial infection 48.12 28.80 14 6534 251 1739982
Rash papular 47.96 28.80 23 6525 1723 1738510
Cholestatic liver injury 47.86 28.80 14 6534 256 1739977
Atrial fibrillation 47.45 28.80 53 6495 15058 1725175
Paradoxical drug reaction 47.07 28.80 16 6532 485 1739748
Pancytopenia 46.68 28.80 46 6502 11311 1728922
Dysuria 46.57 28.80 29 6519 3643 1736590
Emotional distress 46.36 28.80 23 6525 1855 1738378
Toxic skin eruption 46.30 28.80 23 6525 1860 1738373
Dry eye 46.01 28.80 20 6528 1192 1739041
Peripheral swelling 45.89 28.80 39 6509 7932 1732301
Choroiditis 45.45 28.80 10 6538 52 1740181
Cardiac arrest 45.17 28.80 53 6495 15877 1724356
Arthropathy 45.07 28.80 26 6522 2841 1737392
Inappropriate antidiuretic hormone secretion 44.92 28.80 22 6526 1726 1738507
Chronic fatigue syndrome 44.86 28.80 11 6537 98 1740135
Generalised oedema 44.78 28.80 22 6526 1737 1738496
Cutaneous vasculitis 44.48 28.80 13 6535 237 1739996
Hepatitis cholestatic 44.36 28.80 20 6528 1301 1738932
Pneumonia 44.17 28.80 93 6455 46089 1694144
Labelled drug-drug interaction medication error 43.93 28.80 20 6528 1331 1738902
Paraesthesia oral 43.85 28.80 17 6531 755 1739478
Gait inability 43.76 28.80 27 6521 3336 1736897
Mania 43.60 28.80 23 6525 2110 1738123
Skin burning sensation 43.59 28.80 17 6531 767 1739466
Hepatic enzyme increased 43.54 28.80 35 6513 6586 1733647
Alopecia 43.50 28.80 28 6520 3725 1736508
Hepatotoxicity 43.31 28.80 26 6522 3058 1737175
Aspartate aminotransferase increased 43.16 28.80 43 6505 10713 1729520
Nightmare 43.08 28.80 25 6523 2762 1737471
Urinary retention 43.08 28.80 32 6516 5363 1734870
Crystal nephropathy 43.04 28.80 10 6538 69 1740164
Escherichia infection 43.03 28.80 18 6530 975 1739258
Ear pain 43.03 28.80 17 6531 794 1739439
Rash macular 42.94 28.80 22 6526 1900 1738333
Photophobia 42.44 28.80 19 6529 1215 1739018
Rectal haemorrhage 42.31 28.80 32 6516 5510 1734723
Connective tissue disorder 42.19 28.80 10 6538 76 1740157
Hallucination, visual 42.07 28.80 24 6524 2568 1737665
Syncope 41.60 28.80 48 6500 14121 1726112
Tachypnoea 41.43 28.80 23 6525 2335 1737898
Dyspepsia 40.77 28.80 30 6518 4955 1735278
Vanishing bile duct syndrome 40.74 28.80 11 6537 148 1740085
Enthesopathy 40.50 28.80 10 6538 92 1740141
Disorientation 40.48 28.80 31 6517 5438 1734795
Leukocytosis 40.06 28.80 26 6522 3507 1736726
Oedema 40.00 28.80 34 6514 6914 1733319
Oliguria 39.79 28.80 18 6530 1180 1739053
Cardiovascular disorder 39.69 28.80 23 6525 2534 1737699
Trichosporon infection 39.48 28.80 10 6538 103 1740130
General physical health deterioration 39.45 28.80 45 6503 13073 1727160
Necrotising fasciitis 39.39 28.80 15 6533 634 1739599
Aortic aneurysm 39.38 28.80 17 6531 996 1739237
Hypnagogic hallucination 39.37 28.80 8 6540 26 1740207
Myoclonus 39.27 28.80 22 6526 2273 1737960
Diastasis recti abdominis 39.23 28.80 7 6541 8 1740225
Cough 38.82 28.80 54 6494 19143 1721090
Lumbosacral plexus injury 38.20 28.80 6 6542 0 1740233
Food intolerance 37.92 28.80 11 6537 195 1740038
Product use issue 37.62 28.80 36 6512 8535 1731698
Loss of proprioception 37.31 28.80 8 6540 36 1740197
Rash morbilliform 37.17 28.80 13 6535 430 1739803
Memory impairment 37.12 28.80 32 6516 6631 1733602
Loss of consciousness 36.48 28.80 46 6502 14829 1725404
Yellow fever 36.47 28.80 6 6542 2 1740231
Lymphadenopathy 36.47 28.80 26 6522 4088 1736145
Metabolic acidosis 36.46 28.80 29 6519 5373 1734860
Depressed mood 36.18 28.80 23 6525 2993 1737240
Fall 36.07 28.80 63 6485 27151 1713082
Muscle tightness 35.98 28.80 16 6532 1007 1739226
Cellulitis 35.90 28.80 31 6517 6437 1733796
Hyphaema 35.68 28.80 9 6539 91 1740142
Interstitial lung disease 35.68 28.80 37 6511 9659 1730574
Weight bearing difficulty 35.49 28.80 10 6538 159 1740074
Bursitis 35.47 28.80 14 6534 652 1739581
Coagulopathy 35.35 28.80 22 6526 2759 1737474
Gastrointestinal disorder 35.32 28.80 27 6521 4721 1735512
Dyslexia 35.25 28.80 8 6540 49 1740184
Nerve injury 35.23 28.80 13 6535 503 1739730
Dysarthria 35.00 28.80 28 6520 5231 1735002
Petechiae 34.99 28.80 18 6530 1567 1738666
Hypoacusis 34.80 28.80 21 6527 2492 1737741
Ear discomfort 34.71 28.80 12 6536 383 1739850
Constipation 34.60 28.80 45 6503 14955 1725278
Endophthalmitis 34.49 28.80 14 6534 702 1739531
Chest discomfort 34.48 28.80 32 6516 7299 1732934
Abscess 34.35 28.80 19 6529 1915 1738318
Cardiac failure 34.18 28.80 41 6507 12561 1727672
Meningitis 33.91 28.80 15 6533 932 1739301
Feeling hot 33.91 28.80 22 6526 2965 1737268
Intraocular pressure increased 33.78 28.80 16 6532 1165 1739068
Post-traumatic stress disorder 33.60 28.80 11 6537 296 1739937
Mental status changes 33.48 28.80 29 6519 6046 1734187
Groin pain 33.39 28.80 14 6534 763 1739470
Hair colour changes 33.13 28.80 12 6536 440 1739793
Orchitis 32.98 28.80 11 6537 314 1739919
Restless legs syndrome 32.89 28.80 15 6533 1002 1739231
Hepatitis acute 32.83 28.80 16 6532 1241 1738992
Acute respiratory distress syndrome 32.77 28.80 23 6525 3528 1736705
Functional gastrointestinal disorder 32.40 28.80 11 6537 332 1739901
Eye disorder 32.29 28.80 17 6531 1552 1738681
Haemolytic anaemia 32.27 28.80 18 6530 1844 1738389
Paranoia 32.22 28.80 19 6529 2162 1738071
Oral candidiasis 32.21 28.80 16 6532 1293 1738940
Fixed eruption 32.15 28.80 10 6538 227 1740006
Otorrhoea 32.06 28.80 9 6539 141 1740092
Hepatic function abnormal 31.59 28.80 30 6518 7044 1733189
Nutritional condition abnormal 31.53 28.80 8 6540 83 1740150
Tooth injury 31.44 28.80 8 6540 84 1740149
Derealisation 31.22 28.80 9 6539 156 1740077
Idiosyncratic drug reaction 31.00 28.80 9 6539 160 1740073
Anxiety disorder 30.80 28.80 10 6538 262 1739971
Infective aneurysm 30.78 28.80 8 6540 92 1740141
Acute hepatic failure 30.71 28.80 18 6530 2025 1738208
Necrosis 30.43 28.80 14 6534 954 1739279
Mobility decreased 30.21 28.80 23 6525 3997 1736236
Corneal deposits 30.17 28.80 8 6540 100 1740133
Vascular purpura 30.07 28.80 10 6538 283 1739950
Myopathy 29.99 28.80 17 6531 1796 1738437
Screaming 29.68 28.80 11 6537 431 1739802
Nephritis 29.65 28.80 11 6537 432 1739801
Bone pain 29.23 28.80 21 6527 3341 1736892
Hepatosplenomegaly 29.13 28.80 12 6536 625 1739608
Whipple's disease 29.11 28.80 7 6541 57 1740176
Ligament pain 28.97 28.80 6 6542 22 1740211
Lip blister 28.82 28.80 8 6540 120 1740113

Pharmacologic Action:

SourceCodeDescription
ATC J01MA02 ANTIINFECTIVES FOR SYSTEMIC USE
ANTIBACTERIALS FOR SYSTEMIC USE
QUINOLONE ANTIBACTERIALS
Fluoroquinolones
ATC S01AE03 SENSORY ORGANS
OPHTHALMOLOGICALS
ANTIINFECTIVES
Fluoroquinolones
ATC S02AA15 SENSORY ORGANS
OTOLOGICALS
ANTIINFECTIVES
Antiinfectives
ATC S03AA07 SENSORY ORGANS
OPHTHALMOLOGICAL AND OTOLOGICAL PREPARATIONS
ANTIINFECTIVES
Antiinfectives
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
CHEBI has role CHEBI:35441 antiinfective agent
CHEBI has role CHEBI:36047 antibacterial drug
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
FDA EPC N0000175937 Quinolone Antimicrobial
FDA CS M0023650 Quinolones
MeSH PA D059005 Topoisomerase II Inhibitors

Drug Use (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
Skin and Skin Structure Pseudomonas Aeruginosa Infection indication
Complicated UTI with Pseudomonas Aeruginosa indication
Pseudomonas Aeruginosa Joint Infection 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
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
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
Enterococcus Complicated UTI indication
Providencia Urinary Tract 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
Diabetic Foot Infection off-label use
Prevention of Meningococcal Meningitis 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

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% CIPRODEX NOVARTIS N021537 July 18, 2003 RX SUSPENSION/DROPS OTIC 9149486 Sept. 13, 2022 TREATMENT OF ACUTE OTITIS MEDIA
0.3% CIPRODEX NOVARTIS N021537 July 18, 2003 RX SUSPENSION/DROPS OTIC 9345714 Sept. 13, 2022 TREATMENT OF ACUTE OTITIS MEDIA
0.3% CIPRODEX NOVARTIS N021537 July 18, 2003 RX SUSPENSION/DROPS OTIC 9402805 Sept. 13, 2022 TREATMENT OF ACUTE OTITIS EXTERNA
0.3% CIPRODEX NOVARTIS N021537 July 18, 2003 RX SUSPENSION/DROPS OTIC 9402805 Sept. 13, 2022 TREATMENT OF ACUTE OTITIS MEDIA
0.3% CIPRODEX NOVARTIS N021537 July 18, 2003 RX SUSPENSION/DROPS OTIC 8846650 June 4, 2025 TREATMENT OF ACUTE OTITIS MEDIA
6% (60MG/ML) OTIPRIO OTONOMY INC 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 OTONOMY INC 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 OTOVEL LABORATORIOS SALVAT N208251 April 29, 2016 RX SOLUTION/DROPS OTIC 8932610 March 24, 2030 TREATMENT OF ACUTE OTITIS MEDIA
6% (60MG/ML) OTIPRIO OTONOMY INC N207986 Dec. 10, 2015 RX INJECTABLE, SUSPENSION OTIC 8318817 April 27, 2030 TREATMENT OF OTIC INFECTION OR INFLAMMATION

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
6% (60MG/ML) OTIPRIO OTONOMY INC N207986 Dec. 10, 2015 RX INJECTABLE, SUSPENSION OTIC March 2, 2021 TREATMENT OF ACUTE OTITIS EXTERNA IN PATIENTS 6 MONTHS OF AGE AND OLDER DUE TO PSEUDOMONAS AERUGINOSA AND STAPHYLOCOCCUS AUREUS

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 INHIBITOR IC50 6 WOMBAT-PK
DNA topoisomerase 4 subunit A Enzyme IC50 5.66 WOMBAT-PK
DNA topoisomerase 4 subunit A Enzyme IC50 5.60 WOMBAT-PK
DNA gyrase subunit A Enzyme IC50 6.20 WOMBAT-PK
GABA-A receptor; anion channel Ion channel IC50 6.39 CHEMBL
Multidrug resistance protein mdtK Unclassified Kd 4.04 CHEMBL
Histamine H3 receptor GPCR Ki 9.18 CHEMBL

External reference:

IDSource
D002939 MESH_DESCRIPTOR_UI
4019307 VUID
N0000147503 NUI
C0008809 UMLSCUI
D00186 KEGG_DRUG
4BA73M5E37 UNII
86393-32-0 SECONDARY_CAS_RN
5446 INN_ID
7577004 SNOMEDCT_US
4019307 VANDF
76342 MMSL
002882 NDDF
2551 RXNORM
372840008 SNOMEDCT_US
4451 MMSL
d00011 MMSL
CHEMBL8 ChEMBL_ID
CHEMBL1202 ChEMBL_ID
DB00537 DRUGBANK_ID
CHEMBL1077975 ChEMBL_ID
CPF PDB_CHEM_ID
CHEBI:100241 CHEBI
2764 PUBCHEM_CID

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
CILOXAN HUMAN PRESCRIPTION DRUG LABEL 1 0065-0654 OINTMENT 3 mg OPHTHALMIC NDA 11 sections
Ciloxan HUMAN PRESCRIPTION DRUG LABEL 1 0065-0656 SOLUTION/ DROPS 3 mg OPHTHALMIC NDA 13 sections
CIPRO HUMAN PRESCRIPTION DRUG LABEL 2 0065-8531 SUSPENSION 2 mg AURICULAR (OTIC) NDA 11 sections
CIPRODEX HUMAN PRESCRIPTION DRUG LABEL 2 0065-8533 SUSPENSION/ DROPS 3 mg AURICULAR (OTIC) NDA 18 sections
Ciprofloxacin HUMAN PRESCRIPTION DRUG LABEL 1 0143-9927 TABLET, FILM COATED 250 mg ORAL ANDA 19 sections
Ciprofloxacin HUMAN PRESCRIPTION DRUG LABEL 1 0143-9928 TABLET, FILM COATED 500 mg ORAL ANDA 19 sections
Ciprofloxacin HUMAN PRESCRIPTION DRUG LABEL 1 0143-9929 TABLET, FILM COATED 750 mg ORAL ANDA 19 sections
Ciprofloxacin HUMAN PRESCRIPTION DRUG LABEL 1 0172-5311 TABLET, FILM COATED 250 mg ORAL ANDA 20 sections
Ciprofloxacin HUMAN PRESCRIPTION DRUG LABEL 1 0172-5312 TABLET, FILM COATED 500 mg ORAL ANDA 20 sections
Ciprofloxacin HUMAN PRESCRIPTION DRUG LABEL 1 0172-5313 TABLET, FILM COATED 750 mg ORAL ANDA 20 sections
Ciprofloxacin HUMAN PRESCRIPTION DRUG LABEL 1 0179-0188 TABLET, FILM COATED 500 mg ORAL ANDA 20 sections
Ciprofloxacin HUMAN PRESCRIPTION DRUG LABEL 1 0378-7098 TABLET, FILM COATED 500 mg ORAL ANDA 20 sections
Ciprofloxacin HUMAN PRESCRIPTION DRUG LABEL 1 0404-7187 SOLUTION/ DROPS 3 mg OPHTHALMIC ANDA 13 sections
CIPROFLOXACIN HUMAN PRESCRIPTION DRUG LABEL 1 0409-4777 INJECTION, SOLUTION 2 mg INTRAVENOUS ANDA 21 sections
Ciprofloxacin HUMAN PRESCRIPTION DRUG LABEL 1 0615-8147 TABLET, FILM COATED 500 mg ORAL ANDA 20 sections
Ciprofloxacin HUMAN PRESCRIPTION DRUG LABEL 1 0904-6378 TABLET, FILM COATED 500 mg ORAL ANDA 20 sections
Ciprofloxacin HUMAN PRESCRIPTION DRUG LABEL 1 10544-036 TABLET, FILM COATED 500 mg ORAL ANDA 20 sections
ciprofloxacin HUMAN PRESCRIPTION DRUG LABEL 1 10544-079 TABLET 500 mg ORAL ANDA 17 sections
Ciprofloxacin HUMAN PRESCRIPTION DRUG LABEL 1 10544-147 TABLET, FILM COATED 250 mg ORAL ANDA 17 sections
Ciprofloxacin HUMAN PRESCRIPTION DRUG LABEL 1 10544-432 TABLET, FILM COATED 500 mg ORAL ANDA 20 sections
Ciprofloxacin HUMAN PRESCRIPTION DRUG LABEL 1 10544-603 TABLET 250 mg ORAL ANDA 17 sections
CIPROFLOXACIN HUMAN PRESCRIPTION DRUG LABEL 1 10544-604 TABLET, FILM COATED 250 mg ORAL ANDA 18 sections
Ciprofloxacin HUMAN PRESCRIPTION DRUG LABEL 1 10544-605 TABLET, FILM COATED 500 mg ORAL ANDA 15 sections
Ciprofloxacin hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 10544-606 TABLET 500 mg ORAL ANDA 15 sections
CIPROFLOXACIN HUMAN PRESCRIPTION DRUG LABEL 1 10544-607 TABLET, FILM COATED 500 mg ORAL ANDA 18 sections
Ciprofloxacin HUMAN PRESCRIPTION DRUG LABEL 1 10544-608 TABLET 500 mg ORAL ANDA 17 sections
Ciprofloxacin HUMAN PRESCRIPTION DRUG LABEL 1 10544-673 TABLET, FILM COATED 250 mg ORAL ANDA 20 sections
Ciprofloxacin HUMAN PRESCRIPTION DRUG LABEL 1 10544-884 TABLET, FILM COATED 500 mg ORAL ANDA 17 sections
Ciprofloxacin HUMAN PRESCRIPTION DRUG LABEL 1 10544-943 TABLET, FILM COATED 500 mg ORAL ANDA 17 sections
Ciprofloxacin HUMAN PRESCRIPTION DRUG LABEL 1 11819-323 TABLET, FILM COATED 500 mg ORAL ANDA 17 sections