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

Stem definitionDrug idCAS RN
anti-inflammatory agents, ibufenac derivatives 865 15307-86-5

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • diclofenac calcium
  • diclofenac diethylamine
  • diclofenac hydroxyethylpyrrolidine
  • diclofenac
  • diclofenamic acid
  • diclofenac sodium
  • diclofenac potassium
  • diclofenac epolamine
A non-steroidal anti-inflammatory agent (NSAID) with antipyretic and analgesic actions. It is primarily available as the sodium salt.
  • Molecular weight: 296.15
  • Formula: C14H11Cl2NO2
  • CLOGP: 4.58
  • LIPINSKI: 0
  • HAC: 3
  • HDO: 2
  • TPSA: 49.33
  • ALOGS: -4.82
  • ROTB: 4

  • Status: OFP

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

Drug dosage:

DoseUnitRoute
0.10 g O
0.10 g P
0.10 g R
0.10 g O

ADMET properties:

PropertyValueReference
MRTD (Maximum Recommended Therapeutic Daily Dose) 10.85 ┬ÁM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BDDCS (Biopharmaceutical Drug Disposition Classification System) 2 Hosey CM, Chan R, Benet LZ
S (Water solubility) 0.14 mg/mL Hosey CM, Chan R, Benet LZ
EoM (Fraction excreted unchanged in urine) 0.50 % Hosey CM, Chan R, Benet LZ
BA (Bioavailability) 54 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution) 0.22 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 3.50 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.01 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 1.40 hours Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
July 28, 1988 FDA

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
Embolia cutis medicamentosa 708.95 9.63 167 150744 107 46535044
Pemphigus 618.22 9.63 747 150164 44527 46490624
Glossodynia 552.52 9.63 699 150212 43674 46491477
Rheumatoid arthritis 510.42 9.63 1820 149091 238395 46296756
Systemic lupus erythematosus 471.21 9.63 794 150117 64386 46470765
Hand deformity 461.39 9.63 564 150347 34010 46501141
Anti-cyclic citrullinated peptide antibody positive 444.68 9.63 419 150492 18726 46516425
Abdominal discomfort 400.59 9.63 1235 149676 149930 46385221
Pericarditis 382.00 9.63 428 150483 23499 46511652
Wound 350.74 9.63 552 150359 42250 46492901
Death 320.58 9.63 368 150543 335180 46199971
Arthropathy 284.38 9.63 754 150157 83946 46451205
Rheumatoid factor positive 274.87 9.63 335 150576 20126 46515025
Discomfort 264.95 9.63 512 150399 46158 46488993
Contraindicated product administered 257.60 9.63 701 150210 79246 46455905
Product use issue 232.73 9.63 754 150157 93890 46441261
Duodenal ulcer perforation 226.52 9.63 201 150710 8301 46526850
Deafness transitory 199.52 9.63 100 150811 1532 46533619
Pain 198.36 9.63 2382 148529 474566 46060585
Swelling 194.64 9.63 858 150053 123653 46411498
Treatment failure 191.59 9.63 699 150212 92388 46442763
Synovitis 181.38 9.63 520 150391 60555 46474596
Maternal exposure during pregnancy 179.11 9.63 731 150180 101818 46433333
Completed suicide 173.24 9.63 131 150780 145789 46389362
Alopecia 170.11 9.63 1000 149911 161414 46373737
Melaena 154.29 9.63 302 150609 27470 46507681
Gastric ulcer 148.18 9.63 259 150652 21604 46513547
Febrile neutropenia 146.73 9.63 61 150850 94566 46440585
Joint swelling 144.31 9.63 975 149936 165098 46370053
Neutropenia 144.20 9.63 150 150761 143054 46392097
Helicobacter infection 141.40 9.63 182 150729 11554 46523597
Infusion related reaction 136.40 9.63 668 150243 100540 46434611
Pharyngitis 134.68 9.63 220 150691 17363 46517788
Hypersensitivity 129.06 9.63 880 150031 149441 46385710
Sleep disorder 127.06 9.63 386 150525 46409 46488742
Gastrointestinal pain 121.76 9.63 135 150776 7320 46527831
Gastric ulcer perforation 119.70 9.63 63 150848 1074 46534077
Ear infection 114.43 9.63 239 150672 22774 46512377
Musculoskeletal stiffness 104.17 9.63 606 150305 97387 46437764
Ankylosing spondylitis 103.21 9.63 118 150793 6619 46528532
Pneumonia 99.19 9.63 761 150150 375559 46159592
Hip arthroplasty 98.23 9.63 195 150716 17917 46517234
Anaphylactic shock 94.39 9.63 205 150706 20069 46515082
Hepatic enzyme increased 88.36 9.63 508 150403 81279 46453872
Rash 86.59 9.63 1625 149286 354887 46180264
Cardiac failure congestive 85.84 9.63 102 150809 91648 46443503
Shoulder arthroplasty 85.83 9.63 75 150836 3033 46532118
Knee arthroplasty 81.68 9.63 213 150698 23452 46511699
Toxicity to various agents 79.42 9.63 383 150528 211383 46323768
Drug intolerance 78.51 9.63 773 150138 146276 46388875
Duodenal ulcer 76.29 9.63 105 150806 7113 46528038
Angioedema 72.24 9.63 285 150626 39057 46496094
Thrombocytopenia 70.55 9.63 194 150717 126387 46408764
International normalised ratio fluctuation 66.84 9.63 56 150855 2137 46533014
Anaphylactic reaction 65.47 9.63 342 150569 52770 46482381
Plasma cell myeloma 63.74 9.63 32 150879 44446 46490705
Electrocardiogram QT prolonged 63.56 9.63 44 150867 51281 46483870
Oligohydramnios 63.10 9.63 83 150828 5382 46529769
Tonsillar ulcer 63.03 9.63 26 150885 245 46534906
Seizure 62.48 9.63 197 150714 122857 46412294
Device expulsion 61.77 9.63 8 150903 27534 46507617
Large intestinal stenosis 61.26 9.63 49 150862 1750 46533401
Intestinal diaphragm disease 61.13 9.63 20 150891 89 46535062
Large intestinal ulcer 58.57 9.63 61 150850 3078 46532073
Small intestine ulcer 58.40 9.63 26 150885 300 46534851
Haematemesis 58.08 9.63 215 150696 28591 46506560
Type I hypersensitivity 57.64 9.63 53 150858 2293 46532858
Swollen joint count increased 54.70 9.63 52 150859 2348 46532803
Dyspnoea 54.46 9.63 1261 149650 514287 46020864
Arthralgia 53.38 9.63 1549 149362 363054 46172097
Renal failure neonatal 53 9.63 19 150892 117 46535034
Off label use 52.80 9.63 887 150024 378954 46156197
Osteoarthritis 51.88 9.63 361 150550 61664 46473487
Hospitalisation 50.65 9.63 79 150832 63306 46471845
Ileal ulcer 50.59 9.63 26 150885 421 46534730
Product dose omission issue 50.50 9.63 328 150583 168192 46366959
Foot operation 50.20 9.63 69 150842 4668 46530483
Drug hypersensitivity 49.62 9.63 1083 149828 242742 46292409
Ductus arteriosus stenosis foetal 48.51 9.63 17 150894 97 46535054
Hypotension 48.09 9.63 500 150411 232089 46303062
Diarrhoea 45.92 9.63 1419 149492 558183 45976968
Dehydration 45.56 9.63 315 150596 159225 46375926
Porphyria acute 45.50 9.63 23 150888 359 46534792
Gastritis erosive 45.37 9.63 70 150841 5260 46529891
Hypokalaemia 45.31 9.63 140 150771 87884 46447267
Injection site necrosis 44.05 9.63 36 150875 1326 46533825
Foetal methotrexate syndrome 43.98 9.63 14 150897 56 46535095
Rheumatic fever 43.89 9.63 50 150861 2793 46532358
Lower respiratory tract infection viral 43.82 9.63 25 150886 503 46534648
Cardio-respiratory arrest 43.79 9.63 79 150832 59790 46475361
Cardiac arrest 43.60 9.63 148 150763 90251 46444900
Ductus arteriosus premature closure 42.05 9.63 21 150890 319 46534832
Pulmonary mass 41.79 9.63 140 150771 17717 46517434
Duodenal ulcer haemorrhage 41.75 9.63 45 150866 2363 46532788
Pulmonary arterial hypertension 41.33 9.63 16 150895 25912 46509239
Tubulointerstitial nephritis 41.07 9.63 123 150788 14665 46520486
Feeding disorder 40.69 9.63 97 150814 10097 46525054
Atrial fibrillation 40.16 9.63 185 150726 103405 46431746
Pancytopenia 39.18 9.63 142 150769 84916 46450235
Endoscopy abnormal 38.68 9.63 9 150902 5 46535146
Jejunal ulcer 38.68 9.63 14 150897 89 46535062
Aspirin-exacerbated respiratory disease 38.18 9.63 26 150885 722 46534429
Bloody discharge 38.10 9.63 29 150882 962 46534189
Leukopenia 37.86 9.63 105 150806 68238 46466913
Gastrointestinal disorder 37.72 9.63 325 150586 59251 46475900
Cerebrovascular accident 37.67 9.63 183 150728 100856 46434295
Psoriatic arthropathy 37.34 9.63 223 150688 36156 46498995
Sepsis 36.66 9.63 273 150638 135741 46399410
Infection 35.47 9.63 618 150293 132974 46402177
No adverse event 35.38 9.63 35 150876 34196 46500955
Gastrointestinal erosion 35.20 9.63 23 150888 595 46534556
Deafness 35.00 9.63 123 150788 15945 46519206
Cough 34.82 9.63 529 150382 229720 46305431
Intestinal ulcer 34.62 9.63 28 150883 1016 46534135
Blister 34.55 9.63 255 150656 44376 46490775
Large intestine perforation 34.54 9.63 76 150835 7504 46527647
Application site rash 34.22 9.63 42 150869 2540 46532611
Spinal pain 34.09 9.63 89 150822 9803 46525348
Blood lactate dehydrogenase increased 34.05 9.63 144 150767 20356 46514795
White blood cell count decreased 33.82 9.63 218 150693 112013 46423138
Rheumatoid lung 33.46 9.63 34 150877 1666 46533485
Urinary tract infection 32.30 9.63 509 150402 219757 46315394
Fat necrosis 31.88 9.63 21 150890 551 46534600
Constipation 31.72 9.63 385 150526 173712 46361439
Functional gastrointestinal disorder 31.58 9.63 45 150866 3149 46532002
Spinal stenosis 30.83 9.63 100 150811 12443 46522708
Neutrophil count decreased 30.26 9.63 59 150852 43367 46491784
Hypoxia 29.95 9.63 78 150833 51760 46483391
Hypoglycaemia 29.73 9.63 84 150827 54265 46480886
Fibromyalgia 29.18 9.63 210 150701 36253 46498898
Mental status changes 28.99 9.63 49 150862 38039 46497112
Anxiety 28.90 9.63 414 150497 181543 46353608
Gastric ulcer haemorrhage 28.33 9.63 54 150857 4814 46530337
Fluid retention 27.84 9.63 79 150832 50967 46484184
Corneal epithelium defect 27.56 9.63 16 150895 333 46534818
Soft tissue infection 27.53 9.63 33 150878 1947 46533204
Joint dislocation 27.33 9.63 89 150822 11097 46524054
Gastrointestinal haemorrhage 27.05 9.63 375 150536 76998 46458153
Orbital oedema 26.85 9.63 13 150898 184 46534967
Hyperglycaemia 26.80 9.63 45 150866 35026 46500125
Fall 26.76 9.63 835 150076 328262 46206889
Ejection fraction 26.53 9.63 19 150892 573 46534578
Posterior reversible encephalopathy syndrome 26.46 9.63 8 150903 15133 46520018
Acute myeloid leukaemia 26.40 9.63 9 150902 15769 46519382
Platelet count decreased 26.36 9.63 202 150709 99822 46435329
Neonatal respiratory acidosis 26.34 9.63 9 150902 47 46535104
Synostosis 26.18 9.63 9 150902 48 46535103
Disease progression 26.17 9.63 180 150731 91120 46444031
Periorbital oedema 25.85 9.63 53 150858 4982 46530169
Pyrexia 25.76 9.63 896 150015 347906 46187245
C-reactive protein abnormal 25.33 9.63 19 150892 21251 46513900
Grip strength decreased 25.25 9.63 73 150838 8533 46526618
Pulmonary toxicity 24.81 9.63 50 150861 4643 46530508
Lip ulceration 24.42 9.63 29 150882 1694 46533457
Respiratory distress 24.35 9.63 41 150870 31875 46503276
Drug ineffective 24.33 9.63 2523 148388 675315 45859836
Cardiac failure 24.23 9.63 155 150756 79793 46455358
Bradycardia 24.17 9.63 121 150790 66177 46468974
Keratopathy 24.09 9.63 14 150897 292 46534859
Joint stiffness 23.98 9.63 160 150751 26948 46508203
Coma 23.94 9.63 102 150809 58247 46476904
C-reactive protein increased 23.85 9.63 292 150619 58298 46476853
Complication associated with device 23.84 9.63 10 150901 15431 46519720
Abdominal rebound tenderness 23.78 9.63 7 150904 20 46535131
Gastritis 23.60 9.63 191 150720 34187 46500964
Lymphatic fistula 23.46 9.63 21 150890 877 46534274
Pulmonary embolism 23.40 9.63 231 150680 108354 46426797
Pancreatic steatosis 23.33 9.63 22 150889 983 46534168
Lymphocyte stimulation test positive 23.26 9.63 18 150893 612 46534539
Femoral hernia incarcerated 23.24 9.63 21 150890 888 46534263
Congenital pulmonary hypertension 23.21 9.63 9 150902 71 46535080
Neuroleptic malignant syndrome 23.17 9.63 4 150907 11118 46524033
Multiple sclerosis relapse 23.12 9.63 65 150846 42060 46493091
Lyme disease 22.93 9.63 33 150878 2330 46532821
Ovulation disorder 22.83 9.63 7 150904 24 46535127
Conjunctival hyperaemia 22.64 9.63 30 150881 1959 46533192
Gallbladder adenocarcinoma 22.47 9.63 9 150902 78 46535073
Nausea 22.45 9.63 1916 148995 685538 45849613
Live birth 22.43 9.63 79 150832 10251 46524900
Neuropathy peripheral 22.36 9.63 187 150724 90706 46444445
Clostridium difficile infection 22.31 9.63 29 150882 25074 46510077
Infective pulmonary exacerbation of cystic fibrosis 22.27 9.63 4 150907 10803 46524348
Tachycardia 21.86 9.63 211 150700 99411 46435740
Adactyly 21.80 9.63 7 150904 29 46535122
Wrong technique in product usage process 21.79 9.63 96 150815 54326 46480825
Punctate keratitis 21.77 9.63 17 150894 586 46534565
Necrotising fasciitis 21.70 9.63 34 150877 2589 46532562
Blood glucose increased 21.63 9.63 140 150771 71873 46463278
Injection site abscess 21.55 9.63 21 150890 978 46534173
Hypomagnesaemia 21.50 9.63 24 150887 22186 46512965
Pleural effusion 21.16 9.63 169 150742 82783 46452368
Product quality issue 21.08 9.63 53 150858 35595 46499556
Analgesic drug level increased 20.94 9.63 25 150886 1469 46533682
Cognitive disorder 20.92 9.63 56 150855 36827 46498324
Red blood cell sedimentation rate abnormal 20.82 9.63 9 150902 13640 46521511
Pancreatitis 20.64 9.63 72 150839 43555 46491596
Arteriovenous fistula occlusion 20.61 9.63 13 150898 316 46534835
Cytomegalovirus infection 20.60 9.63 17 150894 18127 46517024
Shock 20.58 9.63 131 150780 21714 46513437
Unresponsive to stimuli 20.49 9.63 46 150865 32128 46503023
Pneumonia aspiration 20.28 9.63 45 150866 31560 46503591
Diabetes mellitus 20.24 9.63 88 150823 49977 46485174
Torsade de pointes 20.22 9.63 7 150904 12147 46523004
Gastric haemorrhage 20.05 9.63 53 150858 5881 46529270
Vasoconstriction 20.04 9.63 15 150896 485 46534666
Cyanosis neonatal 19.98 9.63 11 150900 206 46534945
Blood potassium decreased 19.96 9.63 60 150851 38003 46497148
Pain in extremity 19.79 9.63 1024 149887 257656 46277495
Blue toe syndrome 19.70 9.63 13 150898 342 46534809
Paranoia 19.64 9.63 5 150906 10592 46524559
Urinoma 19.41 9.63 7 150904 44 46535107
Rotator cuff repair 19.40 9.63 24 150887 1463 46533688
Neuralgia 19.39 9.63 127 150784 21256 46513895
Iron deficiency anaemia 19.30 9.63 108 150803 17098 46518053
Gastrointestinal ulcer 19.26 9.63 28 150883 1995 46533156
Myocardial infarction 19.17 9.63 212 150699 97316 46437835
Colitis erosive 19.16 9.63 8 150903 78 46535073
Condition aggravated 19.14 9.63 972 149939 244080 46291071
Respiratory failure 19.08 9.63 205 150706 94611 46440540
Musculoskeletal disorder 19.08 9.63 100 150811 15445 46519706
Porphyria 19.00 9.63 9 150902 121 46535030
Urine porphobilinogen increased 18.95 9.63 4 150907 0 46535151
Abdominal pain upper 18.94 9.63 609 150302 144696 46390455
Neoplasm progression 18.81 9.63 36 150875 26647 46508504
Dry skin 18.53 9.63 69 150842 40947 46494204
Gamma-glutamyltransferase increased 18.46 9.63 170 150741 31570 46503581
Asthenia 18.39 9.63 820 150091 310255 46224896
Kounis syndrome 18.32 9.63 21 150890 1181 46533970
Lethargy 18.30 9.63 94 150817 51077 46484074
Wound infection pseudomonas 18.21 9.63 23 150888 1432 46533719
Anterior chamber cell 18.18 9.63 15 150896 560 46534591
Arterial haemorrhage 18.17 9.63 25 150886 1693 46533458
Laparotomy 18.12 9.63 9 150902 135 46535016
Fluid overload 18.03 9.63 38 150873 27147 46508004
Neurotoxicity 18.01 9.63 11 150900 13706 46521445
Libido disorder 17.86 9.63 7 150904 57 46535094
Bone marrow failure 17.63 9.63 44 150867 29625 46505526
Device dislocation 17.58 9.63 27 150884 21775 46513376
Palatal oedema 17.57 9.63 14 150897 497 46534654
Status epilepticus 17.28 9.63 12 150899 13967 46521184
Anuria 17.23 9.63 78 150833 11353 46523798
Premature delivery 17.16 9.63 28 150883 22041 46513110
Weight increased 17.06 9.63 403 150508 164070 46371081
Homicide 17.03 9.63 13 150898 433 46534718
Tenderness 17.01 9.63 103 150808 16778 46518373
Transfusion 16.84 9.63 11 150900 13220 46521931
Device issue 16.83 9.63 24 150887 19956 46515195
Lipoedema 16.81 9.63 9 150902 159 46534992
Pyoderma streptococcal 16.72 9.63 4 150907 3 46535148
Synovial cyst 16.66 9.63 57 150854 7289 46527862
Self-medication 16.58 9.63 27 150884 2125 46533026
Progressive multifocal leukoencephalopathy 16.50 9.63 8 150903 11338 46523813
Depression 16.49 9.63 421 150490 169683 46365468
Viral upper respiratory tract infection 16.40 9.63 55 150856 6963 46528188
Femur-fibula-ulna complex 16.34 9.63 5 150906 17 46535134
Mucosal inflammation 16.07 9.63 68 150843 38908 46496243
Adverse reaction 15.98 9.63 60 150851 8030 46527121
Haemarthrosis 15.96 9.63 32 150879 2961 46532190
Renal tubular necrosis 15.91 9.63 73 150838 10686 46524465
Liver function test increased 15.91 9.63 31 150880 22795 46512356
Congenital tricuspid valve atresia 15.85 9.63 6 150905 44 46535107
Product administered at inappropriate site 15.84 9.63 28 150883 2355 46532796
Peritonitis 15.83 9.63 118 150793 20596 46514555
Aggression 15.76 9.63 31 150880 22713 46512438
Face oedema 15.72 9.63 111 150800 19042 46516109
Emotional distress 15.68 9.63 49 150862 30658 46504493
Therapy non-responder 15.64 9.63 74 150837 41078 46494073
Akathisia 15.58 9.63 3 150908 7711 46527440
Anal erosion 15.51 9.63 5 150906 21 46535130
Asthma 15.33 9.63 206 150705 91336 46443815
Ulcerative keratitis 15.32 9.63 27 150884 2266 46532885
Unevaluable event 15.31 9.63 87 150824 46088 46489063
Tachyarrhythmia 15.28 9.63 41 150870 4591 46530560
Mouth ulceration 15.25 9.63 143 150768 26689 46508462
Abnormal behaviour 15.20 9.63 28 150883 21030 46514121
Porphyrins urine increased 15.15 9.63 5 150906 23 46535128
Acquired porphyria 15.15 9.63 5 150906 23 46535128
Laboratory test abnormal 15.10 9.63 32 150879 22815 46512336
Hypophagia 15.09 9.63 153 150758 29153 46505998
Metastases to liver 15.08 9.63 25 150886 19560 46515591
Extradural abscess 15.05 9.63 15 150896 718 46534433
Bone density decreased 15.04 9.63 67 150844 9685 46525466
Hypocalcaemia 14.94 9.63 41 150870 26744 46508407
Complications of intestinal transplant 14.93 9.63 4 150907 7 46535144
Oesophagitis ulcerative 14.89 9.63 13 150898 525 46534626
Diverticulum intestinal 14.70 9.63 48 150863 5993 46529158
Application site pain 14.70 9.63 37 150874 3986 46531165
Linear IgA disease 14.69 9.63 20 150891 1341 46533810
Tonsillitis 14.46 9.63 42 150869 4922 46530229
Central pain syndrome 14.41 9.63 9 150902 215 46534936
Abnormal loss of weight 14.40 9.63 42 150869 4933 46530218
Muscle tone disorder 14.40 9.63 7 150904 100 46535051
Oesophageal carcinoma recurrent 14.34 9.63 5 150906 28 46535123
Sciatic nerve palsy 14.34 9.63 5 150906 28 46535123
Seroma 14.32 9.63 25 150886 2082 46533069
Asthenopia 14.25 9.63 24 150887 1942 46533209
Injection site pain 14.24 9.63 252 150659 106900 46428251
Application site eczema 14.21 9.63 3 150908 0 46535151
Pseudodiverticular disease 14.21 9.63 3 150908 0 46535151
Injection site hyperaesthesia 14.20 9.63 5 150906 29 46535122
Epistaxis 14.19 9.63 136 150775 64169 46470982
Injection site bruising 14.18 9.63 63 150848 35573 46499578
Schizophrenia 14.14 9.63 5 150906 8563 46526588
Juvenile idiopathic arthritis 14.06 9.63 37 150874 4095 46531056
Porphyrins stool increased 14.06 9.63 5 150906 30 46535121
Therapeutic product effect decreased 14.02 9.63 358 150553 82243 46452908
Nail bed inflammation 13.94 9.63 11 150900 385 46534766
Reticulocytosis 13.92 9.63 7 150904 108 46535043
Hypochromic anaemia 13.87 9.63 20 150891 1415 46533736
Sacroiliitis 13.80 9.63 25 150886 2144 46533007
Alpha tumour necrosis factor increased 13.79 9.63 5 150906 32 46535119
Upper gastrointestinal haemorrhage 13.74 9.63 97 150814 16641 46518510
Ejection fraction decreased 13.72 9.63 23 150888 17914 46517237
Axial spondyloarthritis 13.69 9.63 7 150904 112 46535039
Pneumonitis chemical 13.68 9.63 8 150903 169 46534982
Blood cholesterol increased 13.60 9.63 193 150718 39820 46495331
Balance disorder 13.59 9.63 138 150773 64383 46470768
Deep vein thrombosis 13.54 9.63 179 150732 79594 46455557
Oesophageal adenocarcinoma 13.51 9.63 8 150903 173 46534978
Extrapyramidal disorder 13.50 9.63 10 150901 11258 46523893
Erythematotelangiectatic rosacea 13.45 9.63 4 150907 12 46535139
Neurological procedural complication 13.45 9.63 4 150907 12 46535139
Meteoropathy 13.45 9.63 4 150907 12 46535139
Treatment noncompliance 13.44 9.63 50 150861 29681 46505470
Extravascular haemolysis 13.41 9.63 5 150906 35 46535116
Haematotoxicity 13.38 9.63 3 150908 6930 46528221
Urosepsis 13.38 9.63 18 150893 15335 46519816
Generalised tonic-clonic seizure 13.34 9.63 44 150867 27078 46508073
Diabetic ketoacidosis 13.34 9.63 24 150887 18186 46516965
Joint range of motion decreased 13.21 9.63 89 150822 15035 46520116
Cardiac massage 13.21 9.63 4 150907 13 46535138
Warm type haemolytic anaemia 13.21 9.63 4 150907 13 46535138
Hallucination 13.09 9.63 101 150810 49850 46485301
Muscle injury 13.07 9.63 40 150871 4826 46530325
Application site ulcer 13.06 9.63 7 150904 124 46535027
Peptic ulcer 13.02 9.63 35 150876 3923 46531228
Pharyngo-oesophageal diverticulum 12.98 9.63 4 150907 14 46535137
Eyelid oedema 12.97 9.63 67 150844 10290 46524861
Small intestinal perforation 12.96 9.63 18 150893 1230 46533921
Sopor 12.91 9.63 28 150883 19800 46515351
Perforation bile duct 12.77 9.63 4 150907 15 46535136
Insomnia 12.76 9.63 421 150490 164503 46370648
Chest pain 12.73 9.63 454 150457 175870 46359281
Jaundice 12.72 9.63 146 150765 28699 46506452
Blood count abnormal 12.70 9.63 24 150887 17854 46517297
Tenosynovitis 12.64 9.63 53 150858 7462 46527689
Subdural haematoma 12.63 9.63 14 150897 12983 46522168
Failure to thrive 12.63 9.63 3 150908 6661 46528490
Abortion spontaneous 12.52 9.63 86 150825 43560 46491591
Mania 12.52 9.63 10 150901 10836 46524315
Underdose 12.42 9.63 28 150883 19530 46515621
Injection site ulcer 12.42 9.63 12 150899 553 46534598
Palmar-plantar erythrodysaesthesia syndrome 12.41 9.63 30 150881 20421 46514730
Second primary malignancy 12.41 9.63 3 150908 6581 46528570
Multiple sclerosis 12.35 9.63 40 150871 24751 46510400
Application site injury 12.32 9.63 5 150906 45 46535106
Parotid gland enlargement 12.32 9.63 14 150897 780 46534371
Acute kidney injury 12.30 9.63 903 150008 234952 46300199
Gestational diabetes 12.28 9.63 4 150907 7215 46527936
Central nervous system lesion 12.23 9.63 8 150903 9607 46525544
Papulopustular rosacea 12.19 9.63 4 150907 18 46535133
Fistula discharge 12.18 9.63 15 150896 910 46534241
Craniosynostosis 12.17 9.63 7 150904 143 46535008
Bacteraemia 11.98 9.63 17 150894 14162 46520989
Right ventricular failure 11.97 9.63 21 150890 16072 46519079
Myocarditis 11.97 9.63 5 150906 7734 46527417
Ventricular hypoplasia 11.92 9.63 7 150904 149 46535002
Drug-induced liver injury 11.91 9.63 130 150781 25238 46509913
Atrioventricular dissociation 11.91 9.63 8 150903 217 46534934
Urticaria 11.89 9.63 480 150431 117412 46417739
Blood alkaline phosphatase increased 11.88 9.63 187 150724 39422 46495729
Amenorrhoea 11.87 9.63 7 150904 8888 46526263
Thrombotic microangiopathy 11.86 9.63 6 150905 8300 46526851
Atelectasis 11.85 9.63 27 150884 18763 46516388
Nasal polypectomy 11.85 9.63 4 150907 20 46535131
Tongue oedema 11.77 9.63 34 150877 3972 46531179
Movement disorder 11.77 9.63 94 150817 16755 46518396
Pulmonary oedema 11.74 9.63 107 150804 50998 46484153
Arthritis bacterial 11.72 9.63 43 150868 5693 46529458
Confusional state 11.70 9.63 411 150500 159481 46375670
Enterococcal infection 11.66 9.63 4 150907 6983 46528168
Haematochezia 11.63 9.63 178 150733 37315 46497836
Iris transillumination defect 11.61 9.63 5 150906 53 46535098
Ascites 11.56 9.63 70 150841 36514 46498637
pH body fluid decreased 11.54 9.63 4 150907 22 46535129
Pallor 11.48 9.63 120 150791 23046 46512105
Ataxia 11.47 9.63 17 150894 13913 46521238
Chest discomfort 11.46 9.63 214 150697 90055 46445096
Chronic obstructive pulmonary disease 11.43 9.63 125 150786 57508 46477643
Hypoproteinaemia 11.42 9.63 21 150890 1822 46533329
Mucosal erosion 11.40 9.63 18 150893 1380 46533771
Small intestinal stenosis 11.35 9.63 11 150900 509 46534642
Lip oedema 11.32 9.63 30 150881 3334 46531817
Peritonitis bacterial 11.28 9.63 7 150904 8646 46526505
Fear 11.24 9.63 22 150889 16150 46519001
Intervertebral discitis 11.06 9.63 25 150886 2514 46532637
Gastroduodenal ulcer 11.03 9.63 7 150904 172 46534979
Head titubation 11.00 9.63 12 150899 639 46534512
Anaemia 11.00 9.63 696 150215 255083 46280068
Libido increased 10.95 9.63 13 150898 759 46534392
Psychotic disorder 10.92 9.63 37 150874 22584 46512567
Stress ulcer 10.91 9.63 5 150906 62 46535089
Microcytic anaemia 10.81 9.63 28 150883 3070 46532081
Peritoneal tuberculosis 10.78 9.63 11 150900 542 46534609
Small intestinal haemorrhage 10.76 9.63 21 150890 1905 46533246
Uterine perforation 10.76 9.63 5 150906 7262 46527889
Sebaceous gland infection 10.73 9.63 6 150905 116 46535035
Agonal rhythm 10.72 9.63 4 150907 28 46535123
Dermatitis bullous 10.67 9.63 51 150860 7592 46527559
Heart rate increased 10.55 9.63 174 150737 74617 46460534
Hepatic failure 10.53 9.63 64 150847 33352 46501799
Acute generalised exanthematous pustulosis 10.52 9.63 59 150852 9346 46525805
Blood glucose decreased 10.48 9.63 29 150882 18863 46516288
Gastrointestinal hypermotility 10.46 9.63 6 150905 122 46535029
Intestinal obstruction 10.44 9.63 46 150865 26029 46509122
Small intestine carcinoma 10.42 9.63 8 150903 269 46534882
Dyspnoea exertional 10.41 9.63 108 150803 50181 46484970
Inclusion body myositis 10.34 9.63 3 150908 8 46535143
Agitation 10.28 9.63 122 150789 55293 46479858
Documented hypersensitivity to administered product 10.26 9.63 11 150900 574 46534577
Erosive duodenitis 10.26 9.63 10 150901 466 46534685
Salivary hypersecretion 10.23 9.63 4 150907 6441 46528710
Application site erythema 10.22 9.63 37 150874 4867 46530284
Endoscopy 10.21 9.63 8 150903 277 46534874
Ventricular tachycardia 10.21 9.63 25 150886 16942 46518209
Neutropenic sepsis 10.19 9.63 15 150896 12309 46522842
Drug abuse 10.14 9.63 144 150767 63264 46471887
Lordosis 10.12 9.63 8 150903 281 46534870
Autoimmune hepatitis 10.10 9.63 51 150860 7763 46527388
Osteochondrosis 10.08 9.63 14 150897 956 46534195
Necrolytic migratory erythema 10.08 9.63 3 150908 9 46535142
Laryngeal dyspnoea 10.08 9.63 6 150905 131 46535020
Oxygen saturation decreased 10.06 9.63 160 150751 69004 46466147
Breast cancer metastatic 10.04 9.63 18 150893 13660 46521491
Lividity 9.98 9.63 7 150904 204 46534947
Gastrointestinal amyloidosis 9.95 9.63 5 150906 77 46535074
Metastases to central nervous system 9.93 9.63 13 150898 11208 46523943
Radial nerve palsy 9.93 9.63 9 150902 382 46534769
Dysphagia 9.90 9.63 183 150728 77129 46458022
Nasal disorder 9.86 9.63 22 150889 2192 46532959
Faeces discoloured 9.80 9.63 90 150821 16697 46518454
Mucosa vesicle 9.76 9.63 4 150907 37 46535114
Intestinal haemorrhage 9.74 9.63 27 150884 3081 46532070
Psychomotor hyperactivity 9.74 9.63 10 150901 9603 46525548
Hyperchromic anaemia 9.67 9.63 4 150907 38 46535113
Hiatus hernia 9.64 9.63 96 150815 18206 46516945

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
Death 250.46 10.12 275 68934 357008 29526261
Embolia cutis medicamentosa 245.90 10.12 63 69146 141 29883128
Melaena 202.63 10.12 308 68901 32129 29851140
Gastric ulcer 198.21 10.12 208 69001 14913 29868356
Ankylosing spondylitis 138.40 10.12 101 69108 4433 29878836
Duodenal ulcer 131.18 10.12 137 69072 9764 29873505
Onychoclasis 128.55 10.12 67 69142 1592 29881677
Arthralgia 103.33 10.12 600 68609 135191 29748078
Kounis syndrome 102.97 10.12 58 69151 1615 29881654
Large intestinal stenosis 101.22 10.12 52 69157 1198 29882071
Inflammation 94.62 10.12 177 69032 21849 29861420
Febrile neutropenia 89.89 10.12 69 69140 106624 29776645
Gastric ulcer haemorrhage 89.84 10.12 84 69125 5230 29878039
Large intestinal ulcer 81.52 10.12 50 69159 1636 29881633
Anaphylactic shock 79.15 10.12 127 69082 13866 29869403
Gastritis erosive 78.56 10.12 80 69129 5533 29877736
Angioedema 75.65 10.12 212 68997 34172 29849097
Tooth loss 75.44 10.12 67 69142 3902 29879367
Neutropenia 73.13 10.12 115 69094 128425 29754844
Lymphoma 71.66 10.12 102 69107 10019 29873250
Urticaria 67.95 10.12 278 68931 54328 29828941
Gastric haemorrhage 67.90 10.12 96 69113 9371 29873898
Cardiac failure congestive 65.63 10.12 59 69150 84348 29798921
Pain 65.25 10.12 647 68562 171994 29711275
Intestinal diaphragm disease 65.20 10.12 24 69185 235 29883034
Psoriatic arthropathy 64.40 10.12 124 69085 15637 29867632
Off label use 63.19 10.12 329 68880 248961 29634308
Anaphylactic reaction 63.00 10.12 174 69035 27808 29855461
Pruritus 59.62 10.12 472 68737 117732 29765537
Plasma cell myeloma 58.66 10.12 25 69184 53437 29829832
Macrocephaly 58.38 10.12 24 69185 323 29882946
Joint swelling 56.04 10.12 236 68973 46710 29836559
Type I hypersensitivity 56.01 10.12 32 69177 916 29882353
Pyloric stenosis 55.34 10.12 27 69182 555 29882714
Arthritis 55.19 10.12 152 69057 24249 29859020
Gastric ulcer perforation 52.59 10.12 30 69179 856 29882413
Acute kidney injury 51.43 10.12 903 68306 272939 29610330
Metastases to stomach 50.77 10.12 15 69194 67 29883202
Thrombocytopenia 50.40 10.12 156 69053 136888 29746381
Application site rash 49.02 10.12 28 69181 801 29882468
Toxicity to various agents 48.18 10.12 228 68981 176955 29706314
Duodenal ulcer perforation 47.84 10.12 36 69173 1656 29881613
Atrial fibrillation 47.32 10.12 113 69096 108011 29775258
Cerebrovascular accident 45.27 10.12 77 69132 83400 29799869
Abdominal pain upper 44.64 10.12 272 68937 62279 29820990
C-reactive protein increased 43.93 10.12 208 69001 43265 29840004
Erythema 42.77 10.12 316 68893 77135 29806134
Alopecia 41.55 10.12 118 69091 19157 29864112
Muscle swelling 40.54 10.12 19 69190 356 29882913
Haematemesis 39.64 10.12 142 69067 26061 29857208
Mucosal erosion 39.58 10.12 24 69185 769 29882500
Product dose omission issue 38.33 10.12 98 69111 91533 29791736
Gastrointestinal erosion 38.08 10.12 18 69191 344 29882925
Nephrotic syndrome 36.91 10.12 61 69148 6824 29876445
Seronegative arthritis 36.50 10.12 23 69186 790 29882479
Neoplasm malignant 36.41 10.12 107 69102 17707 29865562
Drug tolerance decreased 36.25 10.12 26 69183 1110 29882159
Glomerulonephritis minimal lesion 35.78 10.12 18 69191 396 29882873
Musculoskeletal stiffness 35.76 10.12 171 69038 35710 29847559
Hospitalisation 35.61 10.12 30 69179 44289 29838980
Sacroiliitis 35.31 10.12 23 69186 837 29882432
Injection site necrosis 33.51 10.12 17 69192 381 29882888
Antidepressant drug level above therapeutic 33.19 10.12 13 69196 153 29883116
Disease progression 32.96 10.12 86 69123 79788 29803481
Toxic epidermal necrolysis 32.23 10.12 103 69106 17837 29865432
Pneumonia 32.02 10.12 562 68647 333744 29549525
Ulcerative keratitis 31.61 10.12 26 69183 1363 29881906
Neck pain 31.25 10.12 113 69096 20831 29862438
Haematochezia 31.19 10.12 159 69050 34063 29849206
Corneal thinning 31.04 10.12 12 69197 136 29883133
Peptic ulcer 30.89 10.12 35 69174 2733 29880536
Mastoid abscess 30.44 10.12 6 69203 0 29883269
Blood pressure measurement 30.28 10.12 12 69197 146 29883123
Swelling 29.94 10.12 163 69046 35812 29847457
Erosive duodenitis 29.16 10.12 25 69184 1388 29881881
Aspirin-exacerbated respiratory disease 28.94 10.12 15 69194 352 29882917
Periorbital oedema 28.84 10.12 37 69172 3289 29879980
Duodenal ulcer haemorrhage 28.63 10.12 44 69165 4628 29878641
Analgesic drug level above therapeutic 28.31 10.12 13 69196 232 29883037
Ligament calcification 28.27 10.12 9 69200 54 29883215
Bronchospasm 28.09 10.12 69 69140 10269 29873000
Platelet dysfunction 27.78 10.12 12 69197 184 29883085
Cardiac septal defect 27.72 10.12 12 69197 185 29883084
Conjunctival hyperaemia 27.60 10.12 30 69179 2237 29881032
Faeces discoloured 26.83 10.12 82 69127 13864 29869405
Microcytic anaemia 26.83 10.12 29 69180 2149 29881120
Sciatic nerve palsy 26.29 10.12 6 69203 6 29883263
Tubulointerstitial nephritis 26.24 10.12 96 69113 17795 29865474
Malignant mesenteric neoplasm 25.71 10.12 8 69201 44 29883225
Weight bearing difficulty 25.59 10.12 19 69190 856 29882413
Renal failure neonatal 25.52 10.12 9 69200 77 29883192
Sepsis 25.49 10.12 216 68993 146179 29737090
Hypotension 25.45 10.12 319 68890 200246 29683023
Lymphocyte stimulation test positive 25.44 10.12 19 69190 864 29882405
Cerebral atrophy congenital 25.41 10.12 8 69201 46 29883223
Nerve stimulation test abnormal 25.36 10.12 5 69204 0 29883269
Hypomagnesaemia 25.32 10.12 4 69205 16594 29866675
Body mass index abnormal 25.32 10.12 9 69200 79 29883190
Grip strength decreased 25.20 10.12 28 69181 2140 29881129
Completed suicide 24.73 10.12 132 69077 99360 29783909
Erythema multiforme 24.64 10.12 56 69153 7929 29875340
Gingivitis ulcerative 24.58 10.12 8 69201 52 29883217
Corneal epithelium defect 24.45 10.12 13 69196 322 29882947
Back pain 24.31 10.12 352 68857 102244 29781025
Mental status changes 24.22 10.12 30 69179 37049 29846220
Blood lactate dehydrogenase increased 24.13 10.12 103 69106 20498 29862771
Keratopathy 24.12 10.12 11 69198 193 29883076
Blister 23.91 10.12 103 69106 20580 29862689
Sciatic nerve injury 23.85 10.12 9 69200 95 29883174
Fatigue 23.83 10.12 562 68647 320111 29563158
Mast cell activation syndrome 23.68 10.12 9 69200 97 29883172
Application site swelling 23.57 10.12 12 69197 271 29882998
Shock 23.54 10.12 110 69099 22749 29860520
Duodenal stenosis 23.47 10.12 11 69198 206 29883063
Electrocardiogram QT prolonged 23.40 10.12 29 69180 35806 29847463
Spinal pain 23.19 10.12 39 69170 4425 29878844
Cytomegalovirus infection 23.03 10.12 13 69196 23661 29859608
Factor VIII deficiency 22.82 10.12 9 69200 108 29883161
Psoriasis 22.63 10.12 172 69037 42334 29840935
Jejunal ulcer perforation 22.52 10.12 8 69201 70 29883199
Product administered at inappropriate site 22.33 10.12 23 69186 1612 29881657
Pancytopenia 22.17 10.12 111 69098 84941 29798328
Disability 22.16 10.12 38 69171 4380 29878889
Pulmonary embolism 22.11 10.12 99 69110 78036 29805233
Blood urea increased 22.07 10.12 136 69073 31245 29852024
Hypoaldosteronism 21.95 10.12 10 69199 175 29883094
Tachycardia 21.73 10.12 92 69117 73647 29809622
Rheumatoid arthritis 21.54 10.12 166 69043 41031 29842238
Oral pruritus 21.43 10.12 11 69198 253 29883016
Incorrect product administration duration 21.36 10.12 35 69174 3887 29879382
Uveitis 21.04 10.12 42 69167 5435 29877834
Kidney duplex 20.99 10.12 12 69197 344 29882925
Gastrointestinal haemorrhage 20.84 10.12 289 68920 83157 29800112
Fluid overload 20.82 10.12 9 69200 19083 29864186
Deep vein thrombosis 20.73 10.12 71 69138 60430 29822839
Subacute endocarditis 20.71 10.12 7 69202 52 29883217
Joint space narrowing 20.59 10.12 7 69202 53 29883216
Corneal perforation 20.54 10.12 9 69200 143 29883126
Gastritis haemorrhagic 20.53 10.12 19 69190 1167 29882102
Upper gastrointestinal haemorrhage 20.52 10.12 103 69106 21925 29861344
Cardio-respiratory arrest 20.49 10.12 66 69143 57240 29826029
Necrotising fasciitis 20.46 10.12 32 69177 3417 29879852
Physical examination abnormal 20.43 10.12 8 69201 94 29883175
Drug interaction 20.30 10.12 604 68605 198964 29684305
Secondary amyloidosis 20.26 10.12 7 69202 56 29883213
Intervertebral disc compression 20.14 10.12 11 69198 288 29882981
Oropharyngeal discomfort 19.99 10.12 21 69188 1506 29881763
Eastern Cooperative Oncology Group performance status 19.75 10.12 6 69203 30 29883239
Omental necrosis 19.75 10.12 6 69203 30 29883239
Platelet function test abnormal 19.44 10.12 8 69201 108 29883161
Mesenteric neoplasm 19.44 10.12 6 69203 32 29883237
Pupils unequal 19.28 10.12 19 69190 1263 29882006
Tissue infiltration 19.25 10.12 7 69202 66 29883203
Hypoglycaemia 18.73 10.12 58 69151 50923 29832346
Suicide attempt 18.70 10.12 147 69062 36550 29846719
Metastases to lung 18.66 10.12 50 69159 7845 29875424
Contraindicated product administered 18.54 10.12 84 69125 17147 29866122
Leukopenia 18.50 10.12 67 69142 56092 29827177
Anuria 18.32 10.12 59 69150 10257 29873012
Hypoosmolar state 18.29 10.12 7 69202 77 29883192
Palmoplantar pustulosis 18.21 10.12 7 69202 78 29883191
Seizure 18.17 10.12 143 69066 98332 29784937
Intestinal ulcer 18.11 10.12 15 69194 794 29882475
Musculoskeletal pain 18.07 10.12 128 69081 30812 29852457
Fibromyalgia 17.96 10.12 26 69183 2592 29880677
Leptotrichia infection 17.90 10.12 7 69202 82 29883187
Deafness congenital 17.82 10.12 6 69203 44 29883225
Cryopyrin associated periodic syndrome 17.82 10.12 6 69203 44 29883225
Nasopharyngitis 17.73 10.12 211 68998 58638 29824631
Eschar 17.62 10.12 13 69196 580 29882689
Persistent corneal epithelial defect 17.36 10.12 5 69204 20 29883249
Acute myeloid leukaemia 17.36 10.12 10 69199 17996 29865273
Tonsil cancer 16.69 10.12 14 69195 754 29882515
Skin necrosis 16.69 10.12 35 69174 4692 29878577
Bacteroides infection 16.65 10.12 7 69202 100 29883169
Oligoarthritis 16.65 10.12 6 69203 55 29883214
Twin pregnancy 16.64 10.12 4 69205 6 29883263
Abdominal pain 16.43 10.12 420 68789 135234 29748035
Neurotoxicity 16.43 10.12 5 69204 13177 29870092
Double stranded DNULL antibody positive 16.40 10.12 7 69202 104 29883165
Respiratory failure 16.39 10.12 151 69058 100491 29782778
Ductus arteriosus premature closure 16.34 10.12 7 69202 105 29883164
Gastric mucosal lesion 16.29 10.12 12 69197 534 29882735
Rash erythematous 16.23 10.12 98 69111 22354 29860915
Full blood count decreased 16.22 10.12 8 69201 15709 29867560
Gastrointestinal ulcer 16.18 10.12 20 69189 1712 29881557
Gastric mucosa erythema 16.16 10.12 9 69200 245 29883024
Iris hypopigmentation 16.14 10.12 5 69204 27 29883242
Medium-chain acyl-coenzyme A dehydrogenase deficiency 16.14 10.12 5 69204 27 29883242
Application site reaction 16.12 10.12 11 69198 433 29882836
Pain in extremity 16.02 10.12 350 68859 109871 29773398
Fragile X syndrome 15.99 10.12 5 69204 28 29883241
Application site erythema 15.99 10.12 23 69186 2280 29880989
Myelodysplastic syndrome 15.97 10.12 12 69197 18766 29864503
Lentigo maligna 15.96 10.12 9 69200 251 29883018
Ureteral disorder 15.95 10.12 8 69201 175 29883094
Melanaemia 15.91 10.12 4 69205 8 29883261
Spondyloarthropathy 15.86 10.12 11 69198 445 29882824
Gastritis 15.79 10.12 90 69119 20108 29863161
Neuroleptic malignant syndrome 15.78 10.12 9 69200 16286 29866983
Soft tissue infection 15.75 10.12 19 69190 1586 29881683
Energy increased 15.73 10.12 17 69192 1259 29882010
Endoscopy abnormal 15.60 10.12 4 69205 9 29883260
Ciliary hyperaemia 15.56 10.12 5 69204 31 29883238
Gout 15.46 10.12 80 69129 17235 29866034
Inflammatory marker increased 15.44 10.12 27 69182 3161 29880108
Renal tubular necrosis 15.42 10.12 73 69136 15178 29868091
Application site vesicles 15.41 10.12 12 69197 581 29882688
Application site eczema 15.30 10.12 4 69205 10 29883259
Pallor 15.29 10.12 92 69117 20957 29862312
Internal limiting membrane peeling 15.22 10.12 3 69206 0 29883269
Leucine aminopeptidase increased 15.22 10.12 3 69206 0 29883269
Urinary tract infection 15.00 10.12 104 69105 73555 29809714
Ultrasound skull abnormal 14.85 10.12 6 69203 77 29883192
CADASIL 14.85 10.12 6 69203 77 29883192
Retroperitoneal fibrosis 14.77 10.12 9 69200 291 29882978
Retinal toxicity 14.76 10.12 10 69199 389 29882880
Mallory-Weiss syndrome 14.68 10.12 17 69192 1359 29881910
Inflammatory bowel disease 14.62 10.12 22 69187 2271 29880998
Magnetic resonance imaging spinal abnormal 14.58 10.12 6 69203 81 29883188
Gastrointestinal wall thickening 14.50 10.12 14 69195 907 29882362
Wound secretion 14.50 10.12 23 69186 2485 29880784
Oligohydramnios 14.50 10.12 9 69200 301 29882968
Tubulointerstitial nephritis and uveitis syndrome 14.47 10.12 5 69204 40 29883229
Oropharyngeal pain 14.44 10.12 114 69095 28382 29854887
Microcephaly 14.41 10.12 12 69197 640 29882629
Acquired haemophilia 14.39 10.12 13 69196 774 29882495
Axillary pain 14.32 10.12 8 69201 219 29883050
Neisseria infection 14.31 10.12 4 69205 14 29883255
Visual evoked potentials abnormal 14.25 10.12 6 69203 86 29883183
Nikolsky's sign 14.23 10.12 8 69201 222 29883047
Skin ulcer 14.09 10.12 83 69126 18766 29864503
Ulcer 14.08 10.12 41 69168 6750 29876519
Procalcitonin increased 13.97 10.12 15 69194 1103 29882166
Oral mucosa erosion 13.96 10.12 13 69196 805 29882464
Intestinal metastasis 13.92 10.12 7 69202 154 29883115
Xanthelasma 13.72 10.12 6 69203 95 29883174
Tumour invasion 13.66 10.12 9 69200 334 29882935
Dehydration 13.65 10.12 202 69007 123337 29759932
White blood cell count decreased 13.64 10.12 126 69083 83821 29799448
Trisomy 8 13.58 10.12 5 69204 49 29883220
Corneal opacity 13.51 10.12 11 69198 568 29882701
Ecthyma 13.45 10.12 9 69200 343 29882926
Ductus arteriosus stenosis foetal 13.44 10.12 6 69203 100 29883169
Desmoid tumour 13.44 10.12 6 69203 100 29883169
Arthritis bacterial 13.43 10.12 31 69178 4433 29878836
Central nervous system inflammation 13.33 10.12 6 69203 102 29883167
Lipid metabolism disorder 13.26 10.12 8 69201 254 29883015
Oculomucocutaneous syndrome 13.25 10.12 7 69202 171 29883098
Thrombosis mesenteric vessel 13.23 10.12 5 69204 53 29883216
Dermatosis 13.20 10.12 8 69201 256 29883013
Neuropathy peripheral 13.15 10.12 102 69107 70373 29812896
Peritonsillitis 13.15 10.12 3 69206 3 29883266
Myofascial pain syndrome 13.13 10.12 9 69200 357 29882912
Duodenal perforation 13.06 10.12 15 69194 1189 29882080
Musculoskeletal discomfort 13.02 10.12 38 69171 6262 29877007
Pharyngitis 12.95 10.12 40 69169 6802 29876467
Large intestine perforation 12.90 10.12 43 69166 7608 29875661
Skin erosion 12.90 10.12 18 69191 1735 29881534
Diarrhoea 12.89 10.12 636 68573 333467 29549802
Drug reaction with eosinophilia and systemic symptoms 12.84 10.12 111 69098 28377 29854892
Noninfective gingivitis 12.77 10.12 8 69201 272 29882997
Gastric bypass 12.77 10.12 8 69201 272 29882997
Duodenal obstruction 12.73 10.12 6 69203 114 29883155
Hypoxia 12.72 10.12 62 69147 47792 29835477
Angiocardiogram 12.72 10.12 7 69202 186 29883083
Application site exfoliation 12.68 10.12 6 69203 115 29883154
Rash 12.64 10.12 553 68656 191336 29691933
Bradycardia 12.62 10.12 94 69115 65432 29817837
Linear IgA disease 12.62 10.12 17 69192 1585 29881684
Discoloured vomit 12.61 10.12 9 69200 381 29882888
Poisoning deliberate 12.58 10.12 36 69173 5868 29877401
Unevaluable event 12.51 10.12 35 69174 31750 29851519
Ejection fraction 12.46 10.12 5 69204 63 29883206
Application site oedema 12.42 10.12 4 69205 25 29883244
Eye pain 12.33 10.12 57 69152 11732 29871537
Intentional product use issue 12.32 10.12 43 69166 36397 29846872
Laryngeal oedema 12.24 10.12 25 69184 3289 29879980
Peritonitis 12.23 10.12 88 69121 21287 29861982
Application site hypersensitivity 12.22 10.12 6 69203 125 29883144
Tension headache 12.19 10.12 15 69194 1278 29881991
Chronic obstructive pulmonary disease 12.12 10.12 60 69149 46066 29837203
Mobility decreased 12.09 10.12 102 69107 25897 29857372
Lipoma 12.08 10.12 16 69193 1467 29881802
Abdominal lymphadenopathy 12.08 10.12 10 69199 529 29882740
Hyperkalaemia 12.06 10.12 217 68992 65793 29817476
Exposure to communicable disease 12.05 10.12 6 69203 129 29883140
Saccadic eye movement 11.97 10.12 6 69203 131 29883138
Metastases to bone 11.86 10.12 49 69160 9609 29873660
Pulmonary hypertension 11.81 10.12 16 69193 19020 29864249
Gastric disorder 11.80 10.12 52 69157 10491 29872778
Slow speech 11.79 10.12 13 69196 985 29882284
Drug hypersensitivity 11.74 10.12 223 68986 68296 29814973
Postictal paralysis 11.69 10.12 6 69203 138 29883131
Corneal transplant 11.69 10.12 4 69205 31 29883238
Skin lesion 11.68 10.12 78 69131 18416 29864853
Stevens-Johnson syndrome 11.67 10.12 75 69134 17481 29865788
Intestinal transit time decreased 11.62 10.12 3 69206 7 29883262
Skin graft 11.59 10.12 10 69199 560 29882709
Tongue oedema 11.51 10.12 22 69187 2758 29880511
Laboratory test abnormal 11.50 10.12 14 69195 17428 29865841
Metastases to heart 11.49 10.12 6 69203 143 29883126
Metastases to peritoneum 11.48 10.12 16 69193 1541 29881728
Pyomyositis 11.46 10.12 6 69203 144 29883125
Small intestine ulcer 11.45 10.12 9 69200 442 29882827
Small intestine carcinoma 11.38 10.12 9 69200 446 29882823
Bicytopenia 11.37 10.12 17 69192 1745 29881524
Osteoarthritis 11.35 10.12 77 69132 18272 29864997
Oral herpes 11.33 10.12 29 69180 4426 29878843
Blood pressure decreased 11.32 10.12 162 69047 46913 29836356
Prurigo 11.31 10.12 11 69198 719 29882550
Face oedema 11.27 10.12 54 69155 11280 29871989
Diabetes mellitus 11.27 10.12 54 69155 41811 29841458
Ileal perforation 11.23 10.12 11 69198 726 29882543
Tenderness 11.22 10.12 34 69175 5721 29877548
Ocular hyperaemia 11.20 10.12 46 69163 8997 29874272
Gouty arthritis 11.20 10.12 13 69196 1042 29882227
Ventricular tachycardia 11.18 10.12 24 69185 23838 29859431
Delirium 11.17 10.12 52 69157 40579 29842690
Intervertebral disc degeneration 11.17 10.12 32 69177 5219 29878050
Scrotal ulcer 11.12 10.12 8 69201 343 29882926
Hypoproteinaemia 10.98 10.12 17 69192 1799 29881470
Pneumonitis 10.98 10.12 30 69179 27424 29855845
Hypermetropia 10.96 10.12 7 69202 246 29883023
Cognitive disorder 10.96 10.12 24 69185 23666 29859603
Visual impairment 10.93 10.12 113 69096 30325 29852944
Platelet count decreased 10.88 10.12 176 69033 105953 29777316
Duodenal ulcer repair 10.84 10.12 3 69206 10 29883259
Lip swelling 10.77 10.12 58 69151 12686 29870583
Coronary artery disease 10.72 10.12 69 69140 49643 29833626
Steroid diabetes 10.72 10.12 14 69195 1267 29882002
Obstruction gastric 10.71 10.12 12 69197 926 29882343
Intestinal angioedema 10.69 10.12 6 69203 166 29883103
Stomatitis 10.68 10.12 47 69162 37232 29846037
Eye swelling 10.63 10.12 45 69164 8919 29874350
Pseudoporphyria 10.60 10.12 7 69202 261 29883008
Helicobacter test positive 10.57 10.12 9 69200 495 29882774
Application site dermatitis 10.53 10.12 4 69205 43 29883226
Cytopenia 10.53 10.12 3 69206 8253 29875016
Hepatitis C 10.53 10.12 9 69200 13196 29870073
Orthostatic hypotension 10.52 10.12 25 69184 23954 29859315
Drug resistance 10.51 10.12 19 69190 20114 29863155
Renal infarct 10.49 10.12 13 69196 1116 29882153
Product quality issue 10.46 10.12 17 69192 18757 29864512
Exostosis 10.40 10.12 24 69185 3431 29879838
Nail bed inflammation 10.31 10.12 6 69203 178 29883091
Schizophrenia 10.29 10.12 4 69205 9044 29874225
Encephalopathy 10.23 10.12 39 69170 32166 29851103
Febrile bone marrow aplasia 10.22 10.12 3 69206 8094 29875175
Bone marrow failure 10.16 10.12 35 69174 29750 29853519

Pharmacologic Action:

SourceCodeDescription
ATC D11AX18 DERMATOLOGICALS
OTHER DERMATOLOGICAL PREPARATIONS
OTHER DERMATOLOGICAL PREPARATIONS
Other dermatologicals
ATC M01AB05 MUSCULO-SKELETAL SYSTEM
ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS
ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS, NON-STEROIDS
Acetic acid derivatives and related substances
ATC M02AA15 MUSCULO-SKELETAL SYSTEM
TOPICAL PRODUCTS FOR JOINT AND MUSCULAR PAIN
TOPICAL PRODUCTS FOR JOINT AND MUSCULAR PAIN
Antiinflammatory preparations, non-steroids for topical use
ATC S01BC03 SENSORY ORGANS
OPHTHALMOLOGICALS
ANTIINFLAMMATORY AGENTS
Antiinflammatory agents, non-steroids
ATC M01AB55 MUSCULO-SKELETAL SYSTEM
ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS
ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS, NON-STEROIDS
Acetic acid derivatives and related substances
ATC S01CC01 SENSORY ORGANS
OPHTHALMOLOGICALS
ANTIINFLAMMATORY AGENTS AND ANTIINFECTIVES IN COMBINATION
Antiinflammatory agents, non-steroids and antiinfectives in combination
FDA CS M0001335 Anti-Inflammatory Agents, Non-Steroidal
FDA MoA N0000000160 Cyclooxygenase Inhibitors
FDA PE N0000008836 Decreased Prostaglandin Production
FDA EPC N0000175722 Nonsteroidal Anti-inflammatory Drug
MeSH PA D000700 Analgesics
MeSH PA D018712 Analgesics, Non-Narcotic
MeSH PA D000893 Anti-Inflammatory Agents
MeSH PA D000894 Anti-Inflammatory Agents, Non-Steroidal
MeSH PA D018501 Antirheumatic Agents
MeSH PA D018373 Peripheral Nervous System Agents
MeSH PA D018689 Sensory System Agents
MeSH PA D016861 Cyclooxygenase Inhibitors
MeSH PA D004791 Enzyme Inhibitors
CHEBI has role CHEBI:35475 non-steroidal anti-inflammatory drugs
CHEBI has role CHEBI:35493 anti-pyretic
CHEBI has role CHEBI:35544 cyclooxygenase inhibitors
CHEBI has role CHEBI:35703 xenobiotic
CHEBI has role CHEBI:78298 environmental contaminants
CHEBI has role CHEBI:88188 allergenic drug

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Ankylosing spondylitis indication 9631008 DOID:7147
Pain indication 22253000
Rheumatoid arthritis indication 69896004 DOID:7148
Actinic keratosis indication 201101007 DOID:8866
Dysmenorrhea indication 266599000
Osteoarthritis indication 396275006
Rheumatoid Arthritis in Patient at High Ulcer Risk indication
Sprains and Strains indication
Postoperative Ocular Pain indication
Post-Op Ocular Inflammation indication
Post-Op Photophobia indication
Osteoarthrosis of the Knee indication
Osteoarthritis in Patients at High Ulcer Risk indication
Renal colic off-label use 7093002
Tendinitis off-label use 34840004 DOID:971
Bursitis off-label use 84017003 DOID:2965
Cystoid macular edema off-label use 193387007 DOID:4447
Prevention of Ocular Surgery-Induced Miosis off-label use
Keratitis contraindication 5888003 DOID:4677
Alcoholism contraindication 7200002
Peptic ulcer contraindication 13200003 DOID:750
Asthenia contraindication 13791008
Infection of skin AND/OR subcutaneous tissue contraindication 19824006
Myocardial infarction contraindication 22298006 DOID:5844
Inflammatory bowel disease contraindication 24526004 DOID:0050589
Dehydration contraindication 34095006
Hypertensive disorder contraindication 38341003 DOID:10763
Gastrointestinal ulcer contraindication 40845000
Body fluid retention contraindication 43498006
Skin ulcer contraindication 46742003
Chronic heart failure contraindication 48447003
Disorder of cardiovascular system contraindication 49601007 DOID:1287
Corneal erosion contraindication 50792001
Duodenal ulcer disease contraindication 51868009 DOID:1724
Gastrointestinal perforation contraindication 51875005
Acute nephropathy contraindication 58574008
Hepatic failure contraindication 59927004
Blood coagulation disorder contraindication 64779008 DOID:1247
Diabetes mellitus contraindication 73211009 DOID:9351
Gastrointestinal hemorrhage contraindication 74474003
Perforation of cornea contraindication 74895004
Corneal ulcer contraindication 91514001 DOID:8463
Corneal degeneration contraindication 111521006 DOID:1237
Open wound contraindication 125643001
Liver function tests abnormal contraindication 166603001
Asthma contraindication 195967001 DOID:2841
Deliveries by cesarean contraindication 200144004
Cerebrovascular accident contraindication 230690007
Coronary artery bypass graft contraindication 232717009
Disease of liver contraindication 235856003 DOID:409
Drug-induced hepatitis contraindication 235876009
Edema contraindication 267038008
Anemia contraindication 271737000 DOID:2355
Pregnancy, function contraindication 289908002
Thromboembolic disorder contraindication 371039008
Cardiovascular event risk contraindication 395112001
Smokes tobacco daily contraindication 449868002
Uterine Rupture in Pregnancy contraindication
Bloody Vomit contraindication
Gynecological Surgery contraindication
Corneal Infiltrates contraindication

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 4.22 acidic
pKa2 0.55 Basic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
1.3% LICART IBSA INST BIO N206976 Dec. 19, 2018 RX SYSTEM TOPICAL Dec. 19, 2021 NEW PRODUCT

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Prostaglandin G/H synthase 2 Enzyme INHIBITOR IC50 7.70 WOMBAT-PK CHEMBL
Prostaglandin G/H synthase 1 Enzyme INHIBITOR IC50 7.52 WOMBAT-PK CHEMBL
UDP-glucuronosyltransferase 1-10 Enzyme Ki 4.55 CHEMBL
Interleukin-8 Cytokine IC50 8.10 CHEMBL
UDP-glucuronosyltransferase 1-6 Enzyme Ki 4.64 CHEMBL
UDP-glucuronosyltransferase 1-7 Enzyme Ki 4.72 CHEMBL
UDP-glucuronosyltransferase 1-9 Enzyme Ki 4.96 CHEMBL
C-X-C chemokine receptor type 1 GPCR IC50 7.92 CHEMBL
UDP-glucuronosyltransferase 1-1 Enzyme Ki 4.28 CHEMBL
Acid-sensing ion channel 3 Ion channel BLOCKER IC50 4 IUPHAR
Aldo-keto reductase family 1 member B10 Enzyme IC50 5.72 CHEMBL
Peroxisome proliferator-activated receptor gamma Nuclear hormone receptor ANTAGONIST Ki 6.20 IUPHAR
Transthyretin Secreted Kd 6 CHEMBL
Aldo-keto reductase family 1 member C3 Enzyme IC50 5.59 CHEMBL
Prostaglandin G/H synthase 2 Enzyme IC50 7.66 CHEMBL
Fatty acid-binding protein, liver Unclassified Ki 5.49 CHEMBL
Prostaglandin G/H synthase 1 Enzyme IC50 8.52 CHEMBL
Prostaglandin G/H synthase 2 Enzyme IC50 7.22 CHEMBL
Prostaglandin G/H synthase 1 Enzyme IC50 7.17 CHEMBL

External reference:

IDSource
4019714 VUID
N0000147806 NUI
D00903 KEGG_DRUG
88170-10-9 SECONDARY_CAS_RN
4019378 VANDF
4019714 VANDF
4020829 VANDF
4027248 VANDF
C0012091 UMLSCUI
CHEBI:47381 CHEBI
DIF PDB_CHEM_ID
CHEMBL139 ChEMBL_ID
CHEMBL1201180 ChEMBL_ID
CHEMBL1200804 ChEMBL_ID
CHEMBL1034 ChEMBL_ID
DB00586 DRUGBANK_ID
D004008 MESH_DESCRIPTOR_UI
C000614065 MESH_SUPPLEMENTAL_RECORD_UI
C064142 MESH_SUPPLEMENTAL_RECORD_UI
3033 PUBCHEM_CID
2714 IUPHAR_LIGAND_ID
3270 INN_ID
144O8QL0L1 UNII
203214 RXNORM
11838 MMSL
23373 MMSL
3184 MMSL
340620 MMSL
37364 MMSL
4582 MMSL
4583 MMSL
4584 MMSL
d00848 MMSL
002391 NDDF
004409 NDDF
004410 NDDF
005170 NDDF
006237 NDDF
108515008 SNOMEDCT_US
363598004 SNOMEDCT_US
425650004 SNOMEDCT_US
426714006 SNOMEDCT_US
62039007 SNOMEDCT_US
7034005 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
ARTHROTEC HUMAN PRESCRIPTION DRUG LABEL 2 0025-1411 TABLET, FILM COATED 50 mg ORAL NDA 30 sections
ARTHROTEC HUMAN PRESCRIPTION DRUG LABEL 2 0025-1421 TABLET, FILM COATED 75 mg ORAL NDA 30 sections
VoltarenArthritis Pain HUMAN OTC DRUG LABEL 1 0067-8152 GEL 10 mg TOPICAL NDA 18 sections
VOLTAREN HUMAN PRESCRIPTION DRUG LABEL 1 0078-0478 SOLUTION 1 mg OPHTHALMIC NDA 16 sections
Diclofenac Potassium HUMAN PRESCRIPTION DRUG LABEL 1 0093-0948 TABLET, FILM COATED 50 mg ORAL ANDA 14 sections
diclofenac epolamine HUMAN PRESCRIPTION DRUG LABEL 1 0093-3225 PATCH 0.01 g TOPICAL NDA authorized generic 30 sections
diclofenac epolamine HUMAN PRESCRIPTION DRUG LABEL 1 0093-3727 SYSTEM 0.01 g TOPICAL NDA AUTHORIZED GENERIC 31 sections
good sense arthritis pain HUMAN OTC DRUG LABEL 1 0113-1189 GEL 10 mg TOPICAL ANDA 17 sections
Diclofenac Sodium HUMAN PRESCRIPTION DRUG LABEL 1 0115-1483 GEL 30 mg TOPICAL ANDA 15 sections
DICLOFENULLC SODIUM HUMAN PRESCRIPTION DRUG LABEL 1 0168-0803 GEL 30 mg TOPICAL NDA authorized generic 27 sections
DICLOFENULLC SODIUM HUMAN PRESCRIPTION DRUG LABEL 1 0168-0844 GEL 30 mg TOPICAL NDA authorized generic 27 sections
Diclofenac Sodium HUMAN PRESCRIPTION DRUG LABEL 1 0228-2550 TABLET, DELAYED RELEASE 50 mg ORAL ANDA 26 sections
Diclofenac Sodium HUMAN PRESCRIPTION DRUG LABEL 1 0228-2551 TABLET, DELAYED RELEASE 75 mg ORAL ANDA 26 sections
Aleve Arthritis Pain Gel HUMAN OTC DRUG LABEL 1 0280-0039 GEL 1 mg TOPICAL ANDA 17 sections
Diclofenac sodium HUMAN OTC DRUG LABEL 1 0363-1210 GEL 10 mg TOPICAL ANDA 17 sections
diclofenac sodium HUMAN OTC DRUG LABEL 1 0363-1871 GEL 10 mg TOPICAL ANDA 17 sections
Diclofenac Sodium Topical Gel 1% Human OTC Drug Label 1 0363-7065 GEL 10 mg TOPICAL ANDA 15 sections
Diclofenac Potassium HUMAN PRESCRIPTION DRUG LABEL 1 0378-2474 TABLET, FILM COATED 50 mg ORAL ANDA 26 sections
Diclofenac Sodium HUMAN PRESCRIPTION DRUG LABEL 1 0378-8750 GEL 10 mg TOPICAL ANDA 28 sections
Diclofenac Sodium HUMAN PRESCRIPTION DRUG LABEL 1 0472-1783 GEL 30 mg TOPICAL ANDA 25 sections
Diclofenac Sodium HUMAN PRESCRIPTION DRUG LABEL 1 0527-2170 TABLET, EXTENDED RELEASE 100 mg ORAL ANDA 13 sections
Diclofenac sodium HUMAN OTC DRUG LABEL 1 0536-1294 GEL 10 mg TOPICAL ANDA 16 sections
Diclofenac Sodium and Misoprostol HUMAN PRESCRIPTION DRUG LABEL 2 0591-0397 TABLET, DELAYED RELEASE 50 mg ORAL ANDA 28 sections
Diclofenac Sodium and Misoprostol HUMAN PRESCRIPTION DRUG LABEL 2 0591-0398 TABLET, DELAYED RELEASE 75 mg ORAL ANDA 28 sections
Solaraze HUMAN PRESCRIPTION DRUG LABEL 1 10337-803 GEL 30 mg TOPICAL NDA 27 sections
Solaraze HUMAN PRESCRIPTION DRUG LABEL 1 10337-844 GEL 30 mg TOPICAL NDA 26 sections
Diclofenac Sodium HUMAN PRESCRIPTION DRUG LABEL 1 10544-114 TABLET, DELAYED RELEASE 50 mg ORAL ANDA 24 sections
Diclofenac SodiumDelayed Release HUMAN PRESCRIPTION DRUG LABEL 1 10544-188 TABLET, DELAYED RELEASE 50 mg ORAL ANDA 28 sections
Diclofenac SodiumDelayed Release HUMAN PRESCRIPTION DRUG LABEL 1 10544-189 TABLET, DELAYED RELEASE 75 mg ORAL ANDA 28 sections
Diclofenac Sodium HUMAN PRESCRIPTION DRUG LABEL 1 10544-921 TABLET, DELAYED RELEASE 75 mg ORAL ANDA 24 sections