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
Drug hypersensitivity 1573.62 24.52 651 7766 45992 2303676
Vomiting 1012.65 24.52 550 7867 71052 2278616
Acute kidney injury 982.07 24.52 404 8013 27718 2321950
Rheumatoid arthritis 852.00 24.52 328 8089 18812 2330856
Drug ineffective 836.40 24.52 551 7866 101073 2248595
Nausea 822.43 24.52 566 7851 111623 2238045
Rash 731.29 24.52 418 7999 59140 2290528
Abdominal discomfort 698.02 24.52 277 8140 17179 2332489
Abdominal pain upper 667.77 24.52 287 8130 21813 2327855
Pain 655.88 24.52 395 8022 61462 2288206
Melaena 641.05 24.52 182 8235 3924 2345744
Gastric ulcer 639.12 24.52 170 8247 2846 2346822
Pharyngitis 599.61 24.52 152 8265 2083 2347585
Drug interaction 579.46 24.52 283 8134 28880 2320788
Weight decreased 562.66 24.52 275 8142 28096 2321572
Dizziness 525.68 24.52 337 8080 58328 2291340
Ear infection 516.59 24.52 148 8269 3293 2346375
Decreased appetite 510.50 24.52 259 8158 28632 2321036
Gastrointestinal haemorrhage 509.24 24.52 201 8216 12234 2337434
Pruritus 497.80 24.52 292 8125 43048 2306620
Deafness transitory 484.06 24.52 83 8334 100 2349568
Anaphylactic reaction 465.33 24.52 176 8241 9529 2340139
Abdominal pain 459.86 24.52 256 8161 34118 2315550
Gastrointestinal pain 448.72 24.52 105 8312 1001 2348667
Dyspnoea 425.09 24.52 332 8085 78401 2271267
Angioedema 405.04 24.52 153 8264 8243 2341425
Embolia cutis medicamentosa 401.87 24.52 67 8350 58 2349610
Gastrointestinal disorder 396.08 24.52 153 8264 8764 2340904
Contraindicated product administered 391.68 24.52 116 8301 2905 2346763
Condition aggravated 389.18 24.52 224 8193 31755 2317913
Haemoglobin decreased 386.45 24.52 185 8232 17966 2331702
Pemphigus 381.38 24.52 84 8333 592 2349076
Anaphylactic shock 380.07 24.52 123 8294 4163 2345505
Headache 377.07 24.52 312 8105 79867 2269801
Anaemia 371.64 24.52 224 8193 34568 2315100
Erythema 368.10 24.52 199 8218 24960 2324708
Haematemesis 361.35 24.52 117 8300 3965 2345703
Pyrexia 354.87 24.52 256 8161 53452 2296216
Diarrhoea 351.44 24.52 305 8112 83259 2266409
Suicide attempt 347.95 24.52 149 8268 11133 2338535
Arthropathy 344.40 24.52 131 8286 7185 2342483
Toxicity to various agents 337.13 24.52 206 8211 32548 2317120
Treatment failure 334.92 24.52 128 8289 7111 2342557
Blood creatinine increased 334.36 24.52 142 8275 10391 2339277
Urticaria 332.96 24.52 184 8233 24077 2325591
Hypersensitivity 321.17 24.52 178 8239 23415 2326253
Infection 315.90 24.52 161 8256 17868 2331800
Overdose 315.02 24.52 166 8251 19741 2329927
Glossodynia 306.73 24.52 87 8330 1858 2347810
Hypophagia 303.22 24.52 102 8315 3898 2345770
Shoulder arthroplasty 301.79 24.52 63 8354 331 2349337
Duodenal ulcer 283.71 24.52 73 8344 1060 2348608
Malaise 280.94 24.52 226 8191 55359 2294309
Drug intolerance 280.15 24.52 136 8281 13581 2336087
Fatigue 278.79 24.52 270 8147 84603 2265065
C-reactive protein increased 276.40 24.52 107 8310 6148 2343520
Alanine aminotransferase increased 271.24 24.52 134 8283 13898 2335770
Systemic lupus erythematosus 270.76 24.52 95 8322 4126 2345542
Oligohydramnios 265.69 24.52 67 8350 893 2348775
Asthenia 265.47 24.52 204 8213 46722 2302946
Deafness 261.86 24.52 83 8334 2618 2347050
Maternal exposure during pregnancy 258.11 24.52 132 8285 14731 2334937
Aspartate aminotransferase increased 254.37 24.52 124 8293 12488 2337180
Intentional overdose 242.46 24.52 116 8301 11205 2338463
Arthralgia 239.30 24.52 204 8213 54081 2295587
Hypotension 237.67 24.52 165 8252 32271 2317397
Tubulointerstitial nephritis 236.67 24.52 75 8342 2363 2347305
Gastric ulcer perforation 233.06 24.52 47 8370 201 2349467
International normalised ratio fluctuation 230.92 24.52 49 8368 282 2349386
Somnolence 226.77 24.52 142 8275 23343 2326325
Swelling 226.74 24.52 125 8292 16225 2333443
Renal failure 225.23 24.52 127 8290 17222 2332446
Renal impairment 224.01 24.52 106 8311 9986 2339682
Gastritis 222.55 24.52 84 8333 4497 2345171
Hyperkalaemia 222.50 24.52 90 8327 5803 2343865
Blood urea increased 219.22 24.52 78 8339 3527 2346141
Product use issue 213.88 24.52 109 8308 12060 2337608
Pain in extremity 212.54 24.52 172 8245 42368 2307300
Blood pressure decreased 211.09 24.52 99 8318 9137 2340531
Haematochezia 210.73 24.52 84 8333 5211 2344457
Loss of consciousness 210.68 24.52 125 8292 18642 2331026
Drug-induced liver injury 209.75 24.52 76 8341 3623 2346045
Peritonitis 208.37 24.52 69 8348 2505 2347163
Feeding disorder 206.50 24.52 60 8357 1398 2348270
Shock 203.88 24.52 76 8341 3928 2345740
Joint swelling 201.87 24.52 117 8300 16702 2332966
Large intestinal stenosis 195.77 24.52 44 8373 343 2349325
Toxic epidermal necrolysis 194.85 24.52 69 8348 3075 2346593
Osteoarthritis 191.96 24.52 85 8332 6861 2342807
Blood lactate dehydrogenase increased 191.64 24.52 70 8347 3414 2346254
Exposure during pregnancy 190.96 24.52 131 8286 25088 2324580
Sleep disorder 187.70 24.52 82 8335 6407 2343261
Jaundice 187.09 24.52 78 8339 5430 2344238
Oedema peripheral 185.99 24.52 126 8291 23637 2326031
Dehydration 178.73 24.52 120 8297 22175 2327493
Hand deformity 177.60 24.52 50 8367 1036 2348632
Back pain 177.29 24.52 137 8280 31522 2318146
Duodenal ulcer perforation 174.43 24.52 39 8378 296 2349372
General physical health deterioration 173.99 24.52 100 8317 14039 2335629
Large intestinal ulcer 173.64 24.52 42 8375 465 2349203
Iron deficiency anaemia 168.81 24.52 56 8361 2043 2347625
Gamma-glutamyltransferase increased 166.44 24.52 72 8345 5490 2344178
Pallor 165.16 24.52 64 8353 3678 2345990
Foot operation 161.89 24.52 43 8374 710 2348958
Drug reaction with eosinophilia and systemic symptoms 160.45 24.52 70 8347 5448 2344220
Musculoskeletal stiffness 159.76 24.52 90 8327 12157 2337511
Rectal haemorrhage 159.65 24.52 71 8346 5785 2343883
Renal tubular necrosis 158.79 24.52 50 8367 1540 2348128
Drug abuse 158.57 24.52 89 8328 11937 2337731
Musculoskeletal disorder 154.80 24.52 55 8362 2473 2347195
Stevens-Johnson syndrome 153.71 24.52 63 8354 4196 2345472
Alopecia 151.79 24.52 108 8309 21893 2327775
Faeces discoloured 150.83 24.52 53 8364 2306 2347362
Anti-cyclic citrullinated peptide antibody positive 147.02 24.52 31 8386 172 2349496
White blood cell count increased 146.80 24.52 71 8346 7007 2342661
Eye disorder 145.41 24.52 56 8361 3163 2346505
Foetal exposure during pregnancy 144.20 24.52 64 8353 5188 2344480
Wound 143.31 24.52 53 8364 2675 2346993
Chest pain 142.89 24.52 115 8302 28022 2321646
Hip arthroplasty 142.25 24.52 48 8369 1846 2347822
International normalised ratio increased 141.40 24.52 70 8347 7266 2342402
Large intestine perforation 139.94 24.52 43 8374 1219 2348449
Blood pressure increased 139.84 24.52 93 8324 16893 2332775
Gastrooesophageal reflux disease 138.36 24.52 74 8343 9021 2340647
Blood alkaline phosphatase increased 136.77 24.52 66 8351 6479 2343189
Oedema 135.81 24.52 76 8341 10127 2339541
Periorbital oedema 135.79 24.52 40 8377 978 2348690
Dyspepsia 135.61 24.52 75 8342 9769 2339899
Duodenal ulcer haemorrhage 135.15 24.52 33 8384 381 2349287
Face oedema 134.34 24.52 56 8361 3892 2345776
Multiple organ dysfunction syndrome 132.86 24.52 68 8349 7573 2342095
Inflammation 130.88 24.52 63 8354 6150 2343518
Circulatory collapse 130.74 24.52 54 8363 3666 2346002
Tachycardia 130.64 24.52 88 8329 16321 2333347
Gastritis erosive 130.09 24.52 37 8380 796 2348872
Abdominal distension 129.00 24.52 74 8343 10337 2339331
Knee arthroplasty 128.80 24.52 50 8367 2885 2346783
Off label use 128.58 24.52 169 8248 73429 2276239
Metabolic acidosis 123.86 24.52 60 8357 5938 2343730
Hypertension 122.56 24.52 104 8313 27257 2322411
Gastric ulcer haemorrhage 120.84 24.52 35 8382 805 2348863
Type I hypersensitivity 120.37 24.52 32 8385 530 2349138
Injection site necrosis 120.23 24.52 30 8387 381 2349287
Aspirin-exacerbated respiratory disease 119.65 24.52 26 8391 170 2349498
Hepatic enzyme increased 119.64 24.52 69 8348 9733 2339935
Syncope 119.02 24.52 84 8333 16791 2332877
Upper gastrointestinal haemorrhage 118.97 24.52 43 8374 2031 2347637
Product use in unapproved indication 118.80 24.52 72 8345 11128 2338540
Gait disturbance 118.36 24.52 94 8323 22451 2327217
Synovitis 118.06 24.52 46 8371 2680 2346988
Therapeutic product effect incomplete 117.65 24.52 70 8347 10461 2339207
Application site rash 117.30 24.52 32 8385 587 2349081
Liver disorder 117.10 24.52 59 8358 6355 2343313
Hepatic function abnormal 117.00 24.52 58 8359 6034 2343634
Colitis 116.18 24.52 55 8362 5171 2344497
Confusional state 116.18 24.52 96 8321 24248 2325420
Completed suicide 115.37 24.52 90 8327 20944 2328724
Hepatitis 114.83 24.52 58 8359 6279 2343389
Small intestine ulcer 113.46 24.52 22 8395 73 2349595
Intestinal diaphragm disease 111.61 24.52 19 8398 21 2349647
Fall 111.13 24.52 126 8291 46973 2302695
Joint dislocation 109.73 24.52 37 8380 1419 2348249
Lactic acidosis 109.09 24.52 53 8364 5277 2344391
Gastrointestinal erosion 108.33 24.52 22 8395 98 2349570
Constipation 106.77 24.52 87 8330 21542 2328126
Adverse reaction 106.67 24.52 37 8380 1547 2348121
Functional gastrointestinal disorder 106.57 24.52 28 8389 442 2349226
Anuria 105.31 24.52 38 8379 1786 2347882
Discomfort 104.68 24.52 51 8366 5108 2344560
Porphyria acute 104.26 24.52 21 8396 89 2349579
Spinal stenosis 102.80 24.52 35 8382 1383 2348285
Ileal ulcer 101.41 24.52 21 8396 105 2349563
Ductus arteriosus premature closure 101.12 24.52 18 8399 31 2349637
Muscle spasms 100.70 24.52 84 8333 21482 2328186
Intestinal ulcer 99.57 24.52 23 8394 205 2349463
Rheumatoid factor positive 99.50 24.52 27 8390 485 2349183
Skin necrosis 98.27 24.52 32 8385 1099 2348569
Blister 97.11 24.52 53 8364 6718 2342950
Hypoaesthesia 94.92 24.52 79 8338 20136 2329532
Premature baby 94.25 24.52 41 8376 3163 2346505
Blood bilirubin increased 94.15 24.52 48 8369 5297 2344371
Chromaturia 93.47 24.52 39 8378 2714 2346954
Tenderness 92.47 24.52 35 8382 1883 2347785
Blood sodium decreased 92.27 24.52 40 8377 3060 2346608
Conjunctival hyperaemia 90.63 24.52 26 8391 577 2349091
Gait inability 89.26 24.52 48 8369 5907 2343761
Analgesic drug level increased 88.85 24.52 22 8395 270 2349398
Cardiac arrest 88.65 24.52 67 8350 14863 2334805
Haematuria 88.54 24.52 43 8374 4275 2345393
Ductus arteriosus stenosis foetal 88.39 24.52 15 8402 16 2349652
Gastric haemorrhage 87.74 24.52 29 8388 1044 2348624
Renal failure neonatal 87.68 24.52 16 8401 34 2349634
Product prescribing error 87.47 24.52 38 8379 2922 2346746
Haemorrhage 87.32 24.52 59 8358 10980 2338688
Bronchospasm 86.69 24.52 38 8379 2986 2346682
Autoimmune hepatitis 85.60 24.52 32 8385 1663 2348005
Necrotising fasciitis 85.27 24.52 24 8393 496 2349172
Hyperhidrosis 84.54 24.52 66 8351 15356 2334312
Drug eruption 83.96 24.52 38 8379 3221 2346447
Asthma 81.31 24.52 57 8360 11257 2338411
Bloody discharge 81.15 24.52 18 8399 131 2349537
Palpitations 80.76 24.52 66 8351 16390 2333278
Intentional product misuse 80.55 24.52 53 8364 9436 2340232
Swollen tongue 79.88 24.52 43 8374 5300 2344368
Colitis ischaemic 79.38 24.52 30 8387 1607 2348061
Eye swelling 78.99 24.52 40 8377 4350 2345318
Abdominal pain lower 78.10 24.52 35 8382 2898 2346770
Rash erythematous 78.08 24.52 44 8373 5932 2343736
Swelling face 75.70 24.52 51 8366 9442 2340226
Live birth 74.91 24.52 27 8390 1264 2348404
Pericarditis 73.86 24.52 28 8389 1512 2348156
Haematocrit decreased 73.78 24.52 38 8379 4280 2345388
Feeling abnormal 73.08 24.52 73 8344 23508 2326160
Blood creatine phosphokinase increased 73.07 24.52 40 8377 5096 2344572
Heart rate increased 73.01 24.52 53 8364 11052 2338616
Purpura 72.94 24.52 29 8388 1781 2347887
Abdominal tenderness 72.60 24.52 25 8392 1022 2348646
Adverse drug reaction 72.10 24.52 47 8370 8236 2341432
Ulcer 71.88 24.52 29 8388 1851 2347817
Medication error 71.71 24.52 42 8375 6089 2343579
Respiratory arrest 71.41 24.52 42 8375 6136 2343532
Colitis microscopic 71.37 24.52 24 8393 912 2348756
Nasal disorder 71.05 24.52 19 8398 322 2349346
Hypersensitivity vasculitis 70.96 24.52 26 8391 1276 2348392
Labelled drug-drug interaction medication error 70.84 24.52 26 8391 1282 2348386
Haematoma 70.43 24.52 39 8378 5082 2344586
Linear IgA disease 70.34 24.52 19 8398 335 2349333
Abnormal loss of weight 70.29 24.52 22 8395 663 2349005
Corneal epithelium defect 70.27 24.52 15 8402 89 2349579
Cough 68.67 24.52 83 8334 33034 2316634
Sepsis 68.18 24.52 63 8354 18425 2331243
Skin lesion 67.56 24.52 35 8382 3990 2345678
Dermatitis bullous 67.31 24.52 26 8391 1478 2348190
Lip swelling 67.08 24.52 37 8380 4784 2344884
Oliguria 66.27 24.52 25 8392 1332 2348336
Leukocytosis 65.55 24.52 33 8384 3543 2346125
Disorientation 65.05 24.52 40 8377 6332 2343336
Red blood cell sedimentation rate increased 64.98 24.52 28 8389 2109 2347559
Autoimmune haemolytic anaemia 64.70 24.52 21 8396 713 2348955
Ocular hyperaemia 64.45 24.52 34 8383 4022 2345646
Cholestasis 64.31 24.52 33 8384 3688 2345980
Blood potassium increased 64.25 24.52 28 8389 2168 2347500
Bradycardia 64.16 24.52 47 8370 9934 2339734
Intestinal haemorrhage 64.11 24.52 20 8397 596 2349072
Anterior chamber cell 63.81 24.52 13 8404 59 2349609
Poisoning 63.64 24.52 30 8387 2790 2346878
Depressed level of consciousness 63.38 24.52 42 8375 7562 2342106
Peripheral swelling 63.02 24.52 59 8358 17538 2332130
Rash maculo-papular 62.94 24.52 34 8383 4218 2345450
Haemodialysis 62.56 24.52 27 8390 2042 2347626
Wheezing 62.45 24.52 39 8378 6345 2343323
Interstitial lung disease 62.35 24.52 42 8375 7770 2341898
Hyponatraemia 62.35 24.52 52 8365 13273 2336395
Paraesthesia 62.29 24.52 65 8352 22023 2327645
Diverticulum intestinal 62.11 24.52 20 8397 662 2349006
Gastrointestinal ulcer 61.40 24.52 17 8400 330 2349338
Soft tissue infection 61.01 24.52 17 8400 338 2349330
Cardio-respiratory arrest 60.91 24.52 44 8373 9102 2340566
Transaminases increased 60.53 24.52 34 8383 4553 2345115
Movement disorder 60.50 24.52 29 8388 2799 2346869
Infusion related reaction 60.43 24.52 45 8372 9751 2339917
Altered state of consciousness 60.32 24.52 32 8385 3828 2345840
Helicobacter infection 60.19 24.52 19 8398 589 2349079
Acute hepatic failure 59.29 24.52 28 8389 2614 2347054
Diarrhoea haemorrhagic 58.84 24.52 23 8394 1350 2348318
Renal disorder 58.50 24.52 33 8384 4455 2345213
Punctate keratitis 58.36 24.52 14 8403 149 2349519
Lyme disease 58.35 24.52 17 8400 399 2349269
Dysphagia 57.91 24.52 49 8368 12756 2336912
Ankylosing spondylitis 57.61 24.52 19 8398 679 2348989
Mouth ulceration 57.12 24.52 31 8386 3881 2345787
Purpura senile 57.02 24.52 10 8407 15 2349653
Homicide 56.87 24.52 13 8404 110 2349558
Application site erythema 56.83 24.52 22 8395 1258 2348410
Rash pruritic 56.55 24.52 39 8378 7496 2342172
Delirium 56.43 24.52 34 8383 5189 2344479
Self-medication 56.33 24.52 18 8399 581 2349087
Fibromyalgia 56.26 24.52 29 8388 3271 2346397
Hiatus hernia 55.90 24.52 25 8392 2059 2347609
Skin exfoliation 55.70 24.52 35 8382 5755 2343913
Pleural effusion 55.55 24.52 46 8371 11622 2338046
Hepatitis cholestatic 55.35 24.52 21 8396 1136 2348532
Tricuspid valve incompetence 54.67 24.52 23 8394 1633 2348035
Speech disorder 54.59 24.52 36 8381 6428 2343240
Necrosis 54.55 24.52 20 8397 983 2348685
Coma 54.52 24.52 41 8376 9015 2340653
Foetal methotrexate syndrome 54.38 24.52 9 8408 7 2349661
Cyanosis 54.33 24.52 28 8389 3157 2346511
Proteinuria 54.29 24.52 27 8390 2823 2346845
Pancytopenia 54.21 24.52 45 8372 11407 2338261
Vision blurred 54.09 24.52 50 8367 14618 2335050
Septic shock 54.09 24.52 37 8380 7017 2342651
Grip strength decreased 53.53 24.52 20 8397 1037 2348631
Seizure 53.45 24.52 63 8354 24403 2325265
Liver injury 53.39 24.52 25 8392 2289 2347379
Urine output decreased 53.18 24.52 22 8395 1497 2348171
Cholelithiasis 53.13 24.52 34 8383 5769 2343899
Neonatal respiratory distress syndrome 53.13 24.52 17 8400 551 2349117
Application site pain 53.08 24.52 22 8395 1504 2348164
Product administered at inappropriate site 53.00 24.52 18 8399 705 2348963
Conjunctivitis 52.59 24.52 25 8392 2368 2347300
Endoscopy abnormal 52.38 24.52 9 8408 11 2349657
Chest discomfort 52.37 24.52 49 8368 14546 2335122
Therapeutic product effect decreased 52.33 24.52 43 8374 10746 2338922
Peptic ulcer 52.24 24.52 17 8400 582 2349086
Contusion 51.82 24.52 46 8371 12764 2336904
Systemic inflammatory response syndrome 51.64 24.52 18 8399 763 2348905
Psoriatic arthropathy 51.61 24.52 29 8388 3885 2345783
Chills 51.60 24.52 50 8367 15502 2334166
Acute generalised exanthematous pustulosis 51.32 24.52 22 8395 1636 2348032
Sinus rhythm 50.87 24.52 11 8406 70 2349598
Jejunal ulcer 50.72 24.52 10 8407 37 2349631
Cyanosis neonatal 50.47 24.52 11 8406 73 2349595
Eyelid oedema 50.39 24.52 25 8392 2601 2347067
Thrombocytopenia 49.85 24.52 54 8363 19077 2330591
Stomatitis 49.84 24.52 40 8377 9670 2339998
Respiratory failure 49.66 24.52 46 8371 13482 2336186
Generalised oedema 49.46 24.52 24 8393 2379 2347289
Agranulocytosis 49.20 24.52 27 8390 3455 2346213
Neonatal respiratory acidosis 49.04 24.52 9 8408 20 2349648
Glomerulonephritis 48.27 24.52 15 8402 441 2349227
Mucosal erosion 48.13 24.52 13 8404 229 2349439
Musculoskeletal pain 48.05 24.52 41 8376 10789 2338879
Muscular weakness 47.75 24.52 47 8370 14850 2334818
Chronic kidney disease 47.59 24.52 28 8389 4090 2345578
Congenital pulmonary hypertension 47.35 24.52 9 8408 26 2349642
Pneumonia 47.32 24.52 86 8331 49210 2300458
Acute myocardial infarction 47.23 24.52 30 8387 5025 2344643
Urinary incontinence 46.87 24.52 28 8389 4205 2345463
Dermatitis allergic 46.83 24.52 22 8395 2029 2347639
Arthritis 46.83 24.52 39 8378 9929 2339739
Injection site abscess 46.69 24.52 14 8403 364 2349304
Dry mouth 46.67 24.52 36 8381 8217 2341451
Petechiae 46.62 24.52 22 8395 2050 2347618
Therapeutic response decreased 46.50 24.52 34 8383 7161 2342507
Burning sensation 46.14 24.52 35 8382 7793 2341875
Drug level increased 46.09 24.52 24 8393 2763 2346905
Product administration error 46.07 24.52 27 8390 3916 2345752
Loss of personal independence in daily activities 45.87 24.52 30 8387 5281 2344387
Enteritis 45.86 24.52 18 8399 1068 2348600
Product monitoring error 45.77 24.52 11 8406 118 2349550
Joint stiffness 45.56 24.52 27 8390 3996 2345672
Blood glucose increased 45.52 24.52 42 8375 12248 2337420
Pain in jaw 45.51 24.52 32 8385 6340 2343328
Tarsal tunnel syndrome 45.50 24.52 9 8408 34 2349634
Spinal pain 45.47 24.52 19 8398 1326 2348342
Skin ulcer 45.34 24.52 27 8390 4032 2345636
Creatinine renal clearance decreased 45.18 24.52 17 8400 899 2348769
Small intestinal stenosis 45.04 24.52 11 8406 127 2349541
Intentional self-injury 44.92 24.52 27 8390 4100 2345568
Gastric disorder 44.92 24.52 26 8391 3684 2345984
Colitis erosive 44.90 24.52 9 8408 37 2349631
Disseminated intravascular coagulation 44.65 24.52 25 8392 3325 2346343
Eating disorder 44.61 24.52 22 8395 2259 2347409
Small intestinal haemorrhage 44.54 24.52 13 8404 307 2349361
Neck pain 44.46 24.52 34 8383 7663 2342005
Polyuria 44.38 24.52 18 8399 1164 2348504
Myalgia 44.33 24.52 56 8361 23277 2326391
Laparotomy 44.25 24.52 10 8407 80 2349588
Rhabdomyolysis 44.05 24.52 32 8385 6672 2342996
Blood cholesterol increased 43.79 24.52 29 8388 5212 2344456
Hepatotoxicity 43.76 24.52 25 8392 3456 2346212
Thrombosis 43.42 24.52 36 8381 9108 2340560
Photosensitivity reaction 43.31 24.52 22 8395 2405 2347263
Blood albumin decreased 43.30 24.52 20 8397 1775 2347893
Lymphocyte stimulation test positive 43.24 24.52 12 8405 235 2349433
Ileal stenosis 43.21 24.52 13 8404 342 2349326
Hepatitis acute 43.05 24.52 19 8398 1516 2348152
Hepatic steatosis 42.89 24.52 24 8393 3189 2346479
Skin disorder 42.78 24.52 25 8392 3606 2346062
Hepatocellular injury 42.77 24.52 26 8391 4029 2345639
Tongue oedema 42.74 24.52 16 8401 834 2348834
Dialysis 42.67 24.52 21 8396 2146 2347522
Hypoproteinaemia 42.57 24.52 13 8404 360 2349308
Urinary retention 42.55 24.52 25 8392 3642 2346026
Scar 42.04 24.52 20 8397 1897 2347771
Hepatic necrosis 42.01 24.52 17 8400 1093 2348575
Ascites 41.95 24.52 29 8388 5591 2344077
Drug ineffective for unapproved indication 41.90 24.52 23 8394 2943 2346725
Gastrointestinal mucosal disorder 41.81 24.52 10 8407 105 2349563
Red blood cell count decreased 41.56 24.52 26 8391 4240 2345428
Tremor 41.51 24.52 51 8366 20610 2329058
Erosive duodenitis 41.47 24.52 10 8407 109 2349559
Vasculitis 41.33 24.52 21 8396 2297 2347371
Gastroenteritis 41.23 24.52 23 8394 3037 2346631
Ulcerative keratitis 40.99 24.52 14 8403 558 2349110
Nephropathy toxic 40.89 24.52 17 8400 1171 2348497
Eye pain 40.71 24.52 27 8390 4864 2344804
Respiratory rate increased 40.02 24.52 18 8399 1502 2348166
Maternal drugs affecting foetus 39.71 24.52 18 8399 1529 2348139
Coma scale abnormal 39.68 24.52 15 8402 803 2348865
Erythema multiforme 39.65 24.52 20 8397 2155 2347513
Incorrect dose administered 39.57 24.52 35 8382 9660 2340008
Blood sodium increased 39.43 24.52 13 8404 464 2349204
Hepatic failure 39.31 24.52 28 8389 5661 2344007
Corneal oedema 39.04 24.52 12 8405 340 2349328
Rotator cuff repair 38.86 24.52 11 8406 232 2349436
Inappropriate antidiuretic hormone secretion 38.52 24.52 20 8397 2289 2347379
Oxygen saturation decreased 38.39 24.52 31 8386 7555 2342113
Rales 38.28 24.52 16 8401 1117 2348551
Hypoalbuminaemia 38.27 24.52 17 8400 1377 2348291
Aplastic anaemia 38.23 24.52 15 8402 889 2348779
Occult blood positive 37.92 24.52 13 8404 524 2349144
Gastrointestinal inflammation 37.57 24.52 14 8403 720 2348948
Impaired gastric emptying 37.46 24.52 15 8402 938 2348730
Pneumoperitoneum 37.40 24.52 11 8406 267 2349401
Corneal abrasion 37.03 24.52 10 8407 176 2349492
Platelet count decreased 36.66 24.52 42 8375 15771 2333897
Urinoma 36.63 24.52 7 8410 21 2349647
Visual acuity reduced 36.43 24.52 26 8391 5272 2344396
Lower gastrointestinal haemorrhage 36.42 24.52 15 8402 1009 2348659
Memory impairment 36.35 24.52 38 8379 12885 2336783
Inappropriate schedule of product administration 36.33 24.52 37 8380 12167 2337501
Staphylococcal infection 36.31 24.52 26 8391 5300 2344368
Areflexia 36.03 24.52 13 8404 610 2349058
Dysuria 35.85 24.52 23 8394 3918 2345750
Insomnia 35.55 24.52 53 8364 25734 2323934
Surgery 35.41 24.52 26 8391 5509 2344159
Skin reaction 35.34 24.52 18 8399 1979 2347689
Endotracheal intubation 35.28 24.52 12 8405 472 2349196
Restlessness 35.13 24.52 24 8393 4539 2345129
Application site pruritus 35.01 24.52 14 8403 872 2348796
Oedema mucosal 34.97 24.52 10 8407 219 2349449
Vestibular disorder 34.93 24.52 10 8407 220 2349448
Colitis ulcerative 34.89 24.52 20 8397 2782 2346886
Foetal growth restriction 34.86 24.52 15 8402 1125 2348543
Cardiac failure 34.80 24.52 36 8381 12058 2337610
Mucosal inflammation 34.47 24.52 25 8392 5199 2344469
Vitamin K deficiency 34.36 24.52 8 8409 74 2349594
Atrial fibrillation 34.35 24.52 38 8379 13730 2335938
Lipoedema 34.32 24.52 7 8410 32 2349636
Libido disorder 34.32 24.52 7 8410 32 2349636
Nasopharyngitis 34.29 24.52 48 8369 22008 2327660
Foetal heart rate abnormal 34.19 24.52 9 8408 143 2349525
Presyncope 34.11 24.52 22 8395 3781 2345887
Mucosal ulceration 33.95 24.52 10 8407 244 2349424
Gastrointestinal ulcer haemorrhage 33.79 24.52 9 8408 150 2349518
Renal injury 33.69 24.52 14 8403 963 2348705
Kounis syndrome 33.64 24.52 10 8407 252 2349416
Platelet count increased 33.41 24.52 18 8399 2219 2347449
Angina pectoris 33.16 24.52 22 8395 3965 2345703
Sopor 33.12 24.52 22 8395 3973 2345695
Acidosis 32.89 24.52 16 8401 1594 2348074
Ventricular hypoplasia 32.72 24.52 7 8410 42 2349626
Caesarean section 32.69 24.52 22 8395 4059 2345609
Duodenal stenosis 32.55 24.52 8 8409 95 2349573
Lymphadenopathy 32.53 24.52 25 8392 5673 2343995
Premature delivery 32.43 24.52 20 8397 3180 2346488
Low birth weight baby 32.42 24.52 13 8404 816 2348852
Dermatitis 32.37 24.52 18 8399 2362 2347306
Heart rate decreased 32.32 24.52 21 8396 3655 2346013
Prothrombin time prolonged 32.27 24.52 16 8401 1661 2348007
Vascular stent thrombosis 32.11 24.52 9 8408 183 2349485
Bradycardia neonatal 32.06 24.52 9 8408 184 2349484
Blood fibrinogen increased 32.06 24.52 9 8408 184 2349484
Head titubation 31.79 24.52 9 8408 190 2349478
Juvenile idiopathic arthritis 31.79 24.52 11 8406 456 2349212
Herpes zoster 31.74 24.52 31 8386 9694 2339974
Coagulopathy 31.58 24.52 19 8398 2890 2346778
Oculomucocutaneous syndrome 31.47 24.52 8 8409 110 2349558
Anal incontinence 31.44 24.52 16 8401 1756 2347912
Fibrosis 31.27 24.52 11 8406 479 2349189
Glomerular filtration rate decreased 30.99 24.52 15 8402 1478 2348190
Vaginal haemorrhage 30.97 24.52 23 8394 4957 2344711
Pharyngeal oedema 30.82 24.52 20 8397 3473 2346195
Vertigo 30.79 24.52 30 8387 9354 2340314
Pneumonitis 30.52 24.52 21 8396 4018 2345650
Congenital tricuspid valve atresia 30.47 24.52 6 8411 22 2349646
Fistula discharge 30.46 24.52 9 8408 222 2349446
Normochromic normocytic anaemia 30.44 24.52 12 8405 720 2348948
Gastroduodenal ulcer 30.44 24.52 7 8410 61 2349607
Pulmonary hypertension 30.41 24.52 23 8394 5095 2344573
Dysarthria 30.30 24.52 25 8392 6277 2343391
Dyspnoea exertional 30.27 24.52 24 8393 5696 2343972
Ecchymosis 30.16 24.52 15 8402 1568 2348100
Resorption bone increased 30.05 24.52 9 8408 233 2349435
Laryngeal oedema 29.97 24.52 14 8403 1274 2348394
Blood pressure systolic increased 29.94 24.52 17 8400 2322 2347346
Eczema 29.88 24.52 19 8398 3186 2346482
Atrial septal defect 29.41 24.52 14 8403 1330 2348338
Inflammatory bowel disease 29.40 24.52 11 8406 572 2349096
Escherichia infection 29.37 24.52 14 8403 1334 2348334
Right ventricular hypertrophy 29.30 24.52 8 8409 147 2349521
Duodenal perforation 29.05 24.52 8 8409 152 2349516
Myocardial infarction 28.99 24.52 41 8376 18972 2330696
Enterocolitis 28.84 24.52 12 8405 828 2348840
Hyperaemia 28.77 24.52 10 8407 420 2349248
Nephrotic syndrome 28.60 24.52 13 8404 1111 2348557
Lung disorder 28.54 24.52 24 8393 6188 2343480
Agitation 28.43 24.52 31 8386 11020 2338648
Suicidal ideation 28.35 24.52 31 8386 11056 2338612
Small intestinal perforation 28.26 24.52 9 8408 287 2349381
Rash macular 28.20 24.52 19 8398 3512 2346156
Epistaxis 27.93 24.52 29 8388 9750 2339918
Bronchitis 27.77 24.52 34 8383 13680 2335988
Haemolytic anaemia 27.72 24.52 15 8402 1866 2347802
Cellulitis 27.57 24.52 28 8389 9173 2340495
Hyperventilation 27.49 24.52 13 8404 1216 2348452
Incorrect route of product administration 27.41 24.52 22 8395 5314 2344354
Urinary tract infection 27.13 24.52 51 8366 29891 2319777
Arrhythmia 27.10 24.52 23 8394 6005 2343663
Reticulocytosis 26.89 24.52 6 8411 45 2349623
Oesophageal ulcer 26.82 24.52 11 8406 732 2348936
Spinal cord disorder 26.68 24.52 8 8409 208 2349460
Body temperature decreased 26.58 24.52 13 8404 1310 2348358
Throat tightness 26.50 24.52 20 8397 4416 2345252
Extravascular haemolysis 26.42 24.52 5 8412 14 2349654
Dysstasia 26.35 24.52 17 8400 2922 2346746
Discoloured vomit 26.33 24.52 6 8411 50 2349618
Hypertensive crisis 26.21 24.52 16 8401 2497 2347171
Disease recurrence 26.21 24.52 18 8399 3433 2346235
Flatulence 26.15 24.52 20 8397 4505 2345163
Debridement 26.03 24.52 9 8408 372 2349296
Influenza 25.99 24.52 32 8385 12946 2336722
Respiratory rate decreased 25.95 24.52 10 8407 564 2349104
Pyelonephritis 25.90 24.52 15 8402 2126 2347542
Oesophagitis ulcerative 25.88 24.52 7 8410 124 2349544
Hypothermia 25.86 24.52 15 8402 2133 2347535
Drug dependence 25.80 24.52 17 8400 3028 2346640
Aphthous ulcer 25.73 24.52 13 8404 1405 2348263
Ileus 25.70 24.52 15 8402 2157 2347511
Oropharyngeal pain 25.69 24.52 30 8387 11488 2338180
Cardiac disorder 25.62 24.52 25 8392 7808 2341860
Intestinal perforation 25.61 24.52 14 8403 1777 2347891
Lymphatic fistula 25.47 24.52 5 8412 18 2349650
Adactyly 25.47 24.52 5 8412 18 2349650
Aplasia cutis congenita 25.47 24.52 5 8412 18 2349650
Rash papular 25.46 24.52 16 8401 2628 2347040
Vasoconstriction 25.37 24.52 7 8410 134 2349534
Weight increased 25.35 24.52 42 8375 22295 2327373
Hepatic lesion 25.33 24.52 10 8407 602 2349066
Blood loss anaemia 25.27 24.52 12 8405 1133 2348535
Body temperature increased 25.17 24.52 17 8400 3154 2346514
Crohn's disease 25.13 24.52 23 8394 6632 2343036
Gastrointestinal mucosa hyperaemia 25.05 24.52 5 8412 20 2349648
Oral mucosa erosion 25.04 24.52 8 8409 258 2349410
Skin discolouration 25.02 24.52 21 8396 5399 2344269
Photophobia 24.97 24.52 15 8402 2274 2347394
Renal pain 24.91 24.52 11 8406 878 2348790
Application site injury 24.85 24.52 5 8412 21 2349647
Pollakiuria 24.83 24.52 18 8399 3738 2345930
Prescription form tampering 24.80 24.52 7 8410 146 2349522
Blood creatine increased 24.78 24.52 10 8407 638 2349030
Foetal death 24.75 24.52 14 8403 1898 2347770
Lip erosion 24.62 24.52 7 8410 150 2349518
Acute respiratory distress syndrome 24.60 24.52 17 8400 3275 2346393
Ectropion 24.58 24.52 6 8411 69 2349599
Cardiovascular disorder 24.58 24.52 15 8402 2340 2347328

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
Acute kidney injury 1022.83 26.09 457 5293 34487 1706544
Melaena 606.65 26.09 189 5561 5021 1736010
Gastric ulcer 485.27 26.09 137 5613 2548 1738483
Drug interaction 428.59 26.09 237 5513 27721 1713310
Pruritus 375.21 26.09 204 5546 23018 1718013
Abdominal pain 347.60 26.09 189 5561 21301 1719730
Angioedema 346.58 26.09 147 5603 9517 1731514
Gastrointestinal haemorrhage 345.90 26.09 165 5585 14102 1726929
Vomiting 330.39 26.09 225 5525 38090 1702941
Urticaria 328.81 26.09 152 5598 12089 1728942
Duodenal ulcer 309.57 26.09 88 5662 1672 1739359
Rash 307.11 26.09 216 5534 38477 1702554
Erythema 304.44 26.09 151 5599 14037 1726994
Haematemesis 278.60 26.09 101 5649 4276 1736755
Anaphylactic reaction 269.92 26.09 108 5642 6005 1735026
Blood creatinine increased 265.68 26.09 137 5613 13809 1727222
Anaemia 265.39 26.09 178 5572 29279 1711752
Abdominal pain upper 259.54 26.09 125 5625 10876 1730155
Drug hypersensitivity 255.11 26.09 137 5613 14998 1726033
Blood urea increased 245.92 26.09 94 5656 4617 1736414
Nausea 241.08 26.09 210 5540 50986 1690045
Hyperkalaemia 238.19 26.09 109 5641 8438 1732593
Drug ineffective 233.10 26.09 227 5523 63574 1677457
Haematochezia 227.62 26.09 90 5660 4842 1736189
Haemoglobin decreased 226.00 26.09 132 5618 16982 1724049
Renal failure 222.00 26.09 138 5612 19879 1721152
Suicide attempt 221.05 26.09 99 5651 7282 1733749
Anaphylactic shock 215.10 26.09 75 5675 2824 1738207
Large intestinal stenosis 206.21 26.09 45 5705 262 1740769
Renal impairment 200.45 26.09 109 5641 12205 1728826
Gastric ulcer haemorrhage 198.57 26.09 55 5695 944 1740087
Gastric haemorrhage 197.94 26.09 71 5679 2907 1738124
Dyspnoea 196.87 26.09 189 5561 51870 1689161
Kounis syndrome 195.63 26.09 46 5704 391 1740640
Rhabdomyolysis 194.02 26.09 103 5647 10987 1730044
Pain 188.34 26.09 139 5611 26518 1714513
Toxic epidermal necrolysis 186.16 26.09 64 5686 2307 1738724
Hypotension 181.65 26.09 142 5608 29512 1711519
Tubulointerstitial nephritis 179.70 26.09 66 5684 2892 1738139
Gastritis erosive 177.39 26.09 50 5700 917 1740114
Inflammation 173.37 26.09 67 5683 3383 1737648
Intentional overdose 171.20 26.09 84 5666 7586 1733445
Pyrexia 170.59 26.09 166 5584 46234 1694797
Diarrhoea 167.59 26.09 176 5574 53676 1687355
C-reactive protein increased 163.64 26.09 75 5675 5810 1735221
Large intestinal ulcer 157.07 26.09 37 5713 317 1740714
Embolia cutis medicamentosa 156.95 26.09 29 5721 57 1740974
Arthralgia 151.55 26.09 116 5634 23328 1717703
Shock 151.14 26.09 64 5686 4097 1736934
Blood pressure decreased 150.77 26.09 77 5673 7569 1733462
Nephrotic syndrome 150.29 26.09 48 5702 1368 1739663
Toxicity to various agents 145.60 26.09 124 5626 29017 1712014
Dizziness 145.34 26.09 133 5617 34228 1706803
Drug abuse 140.54 26.09 90 5660 13599 1727432
Loss of consciousness 133.71 26.09 90 5660 14785 1726246
Oedema peripheral 132.45 26.09 91 5659 15459 1725572
Intestinal diaphragm disease 132.05 26.09 24 5726 41 1740990
Macrocephaly 126.29 26.09 23 5727 40 1740991
Completed suicide 126.20 26.09 90 5660 16222 1724809
Blood alkaline phosphatase increased 125.20 26.09 60 5690 5135 1735896
Duodenal ulcer perforation 125.04 26.09 30 5720 280 1740751
Rectal haemorrhage 124.50 26.09 61 5689 5481 1735550
Drug reaction with eosinophilia and systemic symptoms 123.53 26.09 59 5691 5011 1736020
Malaise 120.17 26.09 112 5638 29453 1711578
Alanine aminotransferase increased 119.28 26.09 78 5672 12200 1728831
Aspartate aminotransferase increased 118.55 26.09 74 5676 10682 1730349
Anuria 117.86 26.09 43 5707 1845 1739186
Hypersensitivity 115.47 26.09 72 5678 10372 1730659
Metabolic acidosis 114.03 26.09 57 5693 5345 1735686
Upper gastrointestinal haemorrhage 111.78 26.09 47 5703 2952 1738079
Syncope 111.46 26.09 79 5671 14090 1726941
Faeces discoloured 111.24 26.09 44 5706 2360 1738671
Swelling 111.09 26.09 61 5689 6935 1734096
Blister 110.09 26.09 51 5699 4041 1736990
Asthenia 108.69 26.09 114 5636 34556 1706475
Overdose 108.57 26.09 83 5667 16618 1724413
Back pain 106.76 26.09 82 5668 16531 1724500
Foetal exposure during pregnancy 105.26 26.09 57 5693 6302 1734729
Periorbital oedema 103.73 26.09 31 5719 703 1740328
Blood lactate dehydrogenase increased 102.60 26.09 47 5703 3628 1737403
Peritonitis 102.33 26.09 43 5707 2696 1738335
Gastritis 100.21 26.09 44 5706 3073 1737958
Gastric ulcer perforation 99.80 26.09 23 5727 177 1740854
Dehydration 98.09 26.09 80 5670 17578 1723453
Application site rash 97.90 26.09 24 5726 247 1740784
Oedema 97.85 26.09 56 5694 6892 1734139
Duodenal ulcer haemorrhage 97.73 26.09 30 5720 747 1740284
Liver disorder 97.42 26.09 52 5698 5584 1735447
Fall 97.09 26.09 96 5654 27118 1713913
Stevens-Johnson syndrome 97.07 26.09 44 5706 3313 1737718
Bronchospasm 95.95 26.09 38 5712 2044 1738987
Pain in extremity 94.93 26.09 80 5670 18392 1722639
Product prescribing error 90.57 26.09 38 5712 2372 1738659
Renal injury 88.90 26.09 31 5719 1163 1739868
Renal tubular necrosis 88.39 26.09 36 5714 2083 1738948
Infection 88.23 26.09 65 5685 12295 1728736
Multiple organ dysfunction syndrome 87.96 26.09 58 5692 9184 1731847
Blood creatine phosphokinase increased 87.76 26.09 57 5693 8799 1732232
Pulmonary oedema 87.19 26.09 51 5699 6535 1734496
Pallor 87.05 26.09 41 5709 3370 1737661
Pyloric stenosis 86.99 26.09 20 5730 152 1740879
Somnolence 82.92 26.09 71 5679 16668 1724363
Incorrect product administration duration 80.90 26.09 28 5722 1027 1740004
General physical health deterioration 78.25 26.09 62 5688 13056 1727975
Cardiac failure 76.11 26.09 60 5690 12542 1728489
Microcytic anaemia 75.94 26.09 21 5729 357 1740674
Joint swelling 75.77 26.09 46 5704 6307 1734724
Gamma-glutamyltransferase increased 74.20 26.09 42 5708 5056 1735975
Jaundice 72.56 26.09 44 5706 6018 1735013
Liver function test abnormal 72.27 26.09 43 5707 5683 1735348
Ulcerative keratitis 71.20 26.09 20 5730 361 1740670
Type I hypersensitivity 70.80 26.09 19 5731 287 1740744
Glomerulonephritis minimal lesion 70.62 26.09 15 5735 75 1740956
Headache 70.58 26.09 91 5659 34285 1706746
Product use in unapproved indication 70.49 26.09 51 5699 9371 1731660
Atrial septal defect 70.39 26.09 27 5723 1331 1739700
Erosive duodenitis 69.93 26.09 18 5732 229 1740802
Gastrointestinal erosion 69.89 26.09 16 5734 119 1740912
Off label use 68.33 26.09 95 5655 38476 1702555
Leukocytosis 67.87 26.09 35 5715 3498 1737533
Cardiac arrest 67.76 26.09 62 5688 15868 1725163
Eye swelling 67.48 26.09 29 5721 1920 1739111
Agranulocytosis 67.47 26.09 35 5715 3541 1737490
Pupils unequal 65.85 26.09 17 5733 219 1740812
Hepatitis 64.59 26.09 38 5712 4917 1736114
Ankylosing spondylitis 64.50 26.09 22 5728 771 1740260
Blood bilirubin increased 64.03 26.09 41 5709 6169 1734862
Chest pain 63.17 26.09 66 5684 19848 1721183
Blood pressure increased 62.35 26.09 50 5700 10703 1730328
Product administered at inappropriate site 62.30 26.09 19 5731 462 1740569
Peripheral swelling 61.57 26.09 44 5706 7927 1733104
Gait disturbance 61.19 26.09 53 5697 12617 1728414
Kidney duplex 60.38 26.09 12 5738 40 1740991
Abdominal distension 60.21 26.09 40 5710 6404 1734627
International normalised ratio increased 59.98 26.09 44 5706 8255 1732776
Wheezing 59.85 26.09 34 5716 4119 1736912
Skin necrosis 59.83 26.09 21 5729 803 1740228
Psoriatic arthropathy 59.73 26.09 28 5722 2275 1738756
Disability 59.66 26.09 19 5731 535 1740496
Gout 59.31 26.09 29 5721 2587 1738444
Drug-induced liver injury 59.12 26.09 31 5719 3206 1737825
Restlessness 58.59 26.09 34 5716 4287 1736744
Cardiac septal defect 58.28 26.09 12 5738 50 1740981
Injection site necrosis 58.05 26.09 15 5735 194 1740837
Swelling face 57.43 26.09 34 5716 4449 1736582
Erythema multiforme 57.24 26.09 25 5725 1721 1739310
Skin exfoliation 57.07 26.09 34 5716 4501 1736530
Depressed level of consciousness 57.00 26.09 39 5711 6553 1734478
Musculoskeletal stiffness 56.17 26.09 37 5713 5839 1735192
Chronic kidney disease 55.98 26.09 33 5717 4284 1736747
Disseminated intravascular coagulation 55.91 26.09 31 5719 3583 1737448
Splenomegaly 55.67 26.09 26 5724 2094 1738937
Hypertension 55.58 26.09 61 5689 19387 1721644
Platelet dysfunction 55.51 26.09 11 5739 36 1740995
Shock haemorrhagic 55.45 26.09 23 5727 1393 1739638
Decreased appetite 55.01 26.09 67 5683 23804 1717227
Soft tissue infection 54.80 26.09 15 5735 245 1740786
Aspirin-exacerbated respiratory disease 54.79 26.09 13 5737 115 1740916
Hepatic function abnormal 54.52 26.09 39 5711 7035 1733996
Colitis 54.32 26.09 32 5718 4148 1736883
Nephropathy toxic 54.19 26.09 24 5726 1708 1739323
Corneal epithelium defect 53.69 26.09 12 5738 79 1740952
Haematocrit decreased 53.67 26.09 32 5718 4241 1736790
Musculoskeletal pain 53.54 26.09 34 5716 5040 1735991
Intestinal ulcer 53.48 26.09 14 5736 191 1740840
Haemorrhage 53.38 26.09 44 5706 9785 1731246
Drug eruption 53.37 26.09 28 5722 2898 1738133
Face oedema 53.27 26.09 26 5724 2310 1738721
Condition aggravated 53.06 26.09 62 5688 21088 1719943
Confusional state 52.76 26.09 62 5688 21216 1719815
Iron deficiency anaemia 52.52 26.09 21 5729 1157 1739874
Sepsis 52.16 26.09 59 5691 19379 1721652
Hyperhidrosis 51.90 26.09 48 5702 12440 1728591
Urine output decreased 51.45 26.09 22 5728 1438 1739593
Seizure 51.41 26.09 60 5690 20381 1720650
White blood cell count increased 51.10 26.09 38 5712 7274 1733757
Mallory-Weiss syndrome 51.08 26.09 15 5735 319 1740712
Paraesthesia 51.02 26.09 44 5706 10407 1730624
Corneal thinning 50.87 26.09 10 5740 31 1741000
Rash erythematous 50.60 26.09 30 5720 3935 1737096
Abdominal discomfort 50.04 26.09 41 5709 9040 1731991
Cyanosis 49.94 26.09 26 5724 2648 1738383
Labelled drug-drug interaction medication error 49.73 26.09 21 5729 1330 1739701
Weight decreased 49.42 26.09 62 5688 22691 1718340
Eschar 49.25 26.09 12 5738 120 1740911
Large intestine perforation 49.00 26.09 20 5730 1162 1739869
Neonatal respiratory distress syndrome 48.46 26.09 18 5732 811 1740220
Lactic acidosis 48.30 26.09 32 5718 5097 1735934
Inappropriate schedule of product administration 48.22 26.09 37 5713 7422 1733609
Haematuria 47.78 26.09 37 5713 7523 1733508
Fatigue 47.68 26.09 94 5656 50687 1690344
Septic shock 47.61 26.09 38 5712 8071 1732960
Mast cell activation syndrome 46.94 26.09 8 5742 7 1741024
Gastrointestinal ulcer 46.89 26.09 14 5736 316 1740715
Unresponsive to stimuli 46.32 26.09 30 5720 4599 1736432
Pancytopenia 45.93 26.09 43 5707 11314 1729717
Tongue oedema 45.92 26.09 16 5734 598 1740433
Gastrointestinal disorder 45.62 26.09 30 5720 4718 1736313
Intervertebral disc compression 45.54 26.09 10 5740 60 1740971
Skin discolouration 45.23 26.09 25 5725 2871 1738160
Small intestinal perforation 45.16 26.09 14 5736 360 1740671
Peptic ulcer 44.80 26.09 15 5735 496 1740535
Skin lesion 44.62 26.09 25 5725 2947 1738084
Application site swelling 44.62 26.09 11 5739 116 1740915
Eczema 44.56 26.09 23 5727 2301 1738730
Scar 43.87 26.09 17 5733 861 1740170
Hypoaldosteronism 43.80 26.09 9 5741 37 1740994
Muscular weakness 43.75 26.09 40 5710 10209 1730822
Circulatory collapse 43.63 26.09 26 5724 3441 1737590
Skin ulcer 43.35 26.09 24 5726 2764 1738267
Hypovolaemic shock 43.32 26.09 17 5733 891 1740140
Renal failure neonatal 43.24 26.09 9 5741 40 1740991
Hypoaesthesia 43.19 26.09 39 5711 9796 1731235
Nikolsky's sign 42.82 26.09 10 5740 82 1740949
Blood potassium increased 42.72 26.09 23 5727 2507 1738524
Mobility decreased 42.56 26.09 27 5723 3993 1737038
Factor VIII deficiency 42.53 26.09 9 5741 44 1740987
Abdominal tenderness 42.35 26.09 15 5735 589 1740442
Pancreatitis acute 42.16 26.09 27 5723 4060 1736971
Microcephaly 42.09 26.09 11 5739 149 1740882
Dyspepsia 41.92 26.09 29 5721 4956 1736075
Sopor 41.85 26.09 21 5729 1980 1739051
Eye pain 41.64 26.09 22 5728 2309 1738722
Application site erythema 41.63 26.09 15 5735 619 1740412
Presyncope 41.33 26.09 23 5727 2675 1738356
Cold sweat 41.30 26.09 20 5730 1746 1739285
Duodenitis 41.29 26.09 15 5735 634 1740397
Leptotrichia infection 41.14 26.09 7 5743 6 1741025
Myalgia 41.09 26.09 47 5703 15611 1725420
Protein total decreased 40.80 26.09 15 5735 656 1740375
Mixed liver injury 40.61 26.09 12 5738 261 1740770
Gastritis haemorrhagic 40.56 26.09 12 5738 262 1740769
Application site vesicles 39.88 26.09 11 5739 185 1740846
Thrombotic thrombocytopenic purpura 39.84 26.09 15 5735 702 1740329
Lower gastrointestinal haemorrhage 39.33 26.09 17 5733 1140 1739891
Heart rate increased 39.27 26.09 31 5719 6479 1734552
Concomitant disease aggravated 39.12 26.09 15 5735 738 1740293
Platelet count decreased 39.04 26.09 47 5703 16476 1724555
Bradycardia 39.01 26.09 38 5712 10496 1730535
Oesophagitis 38.98 26.09 19 5731 1682 1739349
Oliguria 38.76 26.09 17 5733 1181 1739850
Troponin I increased 38.69 26.09 12 5738 309 1740722
Nephrolithiasis 37.81 26.09 25 5725 3967 1737064
Tonsil cancer 37.64 26.09 10 5740 145 1740886
Diarrhoea haemorrhagic 37.45 26.09 16 5734 1043 1739988
Gastric disorder 37.20 26.09 19 5731 1859 1739172
Poisoning 37.20 26.09 21 5729 2511 1738520
Small intestinal haemorrhage 37.08 26.09 12 5738 356 1740675
Normochromic normocytic anaemia 37.04 26.09 14 5736 662 1740369
Prothrombin time prolonged 36.83 26.09 18 5732 1603 1739428
Tachycardia 36.72 26.09 40 5710 12588 1728443
Platelet function test abnormal 36.72 26.09 8 5742 46 1740985
Haemodialysis 36.56 26.09 21 5729 2595 1738436
Coma 36.29 26.09 31 5719 7231 1733800
Vision blurred 36.19 26.09 33 5717 8390 1732641
Cerebral atrophy congenital 35.91 26.09 6 5744 4 1741027
Maternal drugs affecting foetus 35.90 26.09 16 5734 1155 1739876
Ulcer 35.90 26.09 16 5734 1155 1739876
Transaminases increased 35.82 26.09 24 5726 3893 1737138
Gastric perforation 35.58 26.09 12 5738 406 1740625
Coagulopathy 35.37 26.09 21 5729 2760 1738271
Lip swelling 35.27 26.09 21 5729 2774 1738257
Autoimmune haemolytic anaemia 35.22 26.09 14 5736 759 1740272
Proteinuria 34.93 26.09 21 5729 2823 1738208
Cholestasis 34.82 26.09 23 5727 3642 1737389
Dysuria 34.78 26.09 23 5727 3649 1737382
Craniocerebral injury 34.76 26.09 12 5738 436 1740595
Rheumatoid arthritis 34.67 26.09 25 5725 4560 1736471
Slow speech 34.58 26.09 10 5740 201 1740830
Fibrosis 34.50 26.09 12 5738 446 1740585
Gastric mucosal lesion 34.43 26.09 9 5741 122 1740909
Hyponatraemia 34.32 26.09 33 5717 8967 1732064
Cerebral haemorrhage 33.85 26.09 28 5722 6249 1734782
Acute myocardial infarction 33.72 26.09 32 5718 8555 1732476
Ecthyma 33.49 26.09 8 5742 73 1740958
Hand fracture 33.47 26.09 11 5739 343 1740688
Wound secretion 33.45 26.09 12 5738 489 1740542
Fixed eruption 33.43 26.09 10 5740 227 1740804
Retinal toxicity 33.34 26.09 9 5741 139 1740892
Vertigo 33.23 26.09 24 5726 4389 1736642
Arthritis 33.13 26.09 23 5727 3952 1737079
Portal vein thrombosis 33.11 26.09 13 5737 682 1740349
Urinary incontinence 33.08 26.09 20 5730 2716 1738315
Therapeutic product effect incomplete 32.97 26.09 26 5724 5422 1735609
Sciatic nerve injury 32.95 26.09 7 5743 35 1740996
Contraindicated product administered 32.70 26.09 16 5734 1428 1739603
Paraplegia 32.51 26.09 12 5738 531 1740500
Duodenal stenosis 32.48 26.09 8 5742 84 1740947
Ascites 32.40 26.09 26 5724 5560 1735471
Visual impairment 32.00 26.09 27 5723 6191 1734840
Mucosal erosion 32.00 26.09 9 5741 163 1740868
Intentional product misuse 31.95 26.09 29 5721 7329 1733702
Product use issue 31.88 26.09 31 5719 8540 1732491
Flank pain 31.81 26.09 14 5736 981 1740050
Anal haemorrhage 31.41 26.09 10 5740 281 1740750
Hepatic failure 31.14 26.09 26 5724 5877 1735154
Otitis media 31.10 26.09 11 5739 430 1740601
Dysphonia 30.64 26.09 21 5729 3534 1737497
Red blood cell sedimentation rate increased 30.55 26.09 14 5736 1079 1739952
Hemiparesis 30.54 26.09 19 5731 2715 1738316
Renal disorder 30.26 26.09 22 5728 4064 1736967
Persistent corneal epithelial defect 30.13 26.09 5 5745 3 1741028
Corneal oedema 30.09 26.09 10 5740 323 1740708
Renal tubular acidosis 30.09 26.09 10 5740 323 1740708
Alcohol interaction 29.97 26.09 10 5740 327 1740704
Protein urine present 29.97 26.09 12 5738 663 1740368
Diverticulum intestinal 29.79 26.09 11 5739 487 1740544
Gouty arthritis 29.66 26.09 9 5741 215 1740816
Hypoalbuminaemia 29.58 26.09 15 5735 1445 1739586
Left ventricular failure 29.55 26.09 12 5738 688 1740343
Nerve stimulation test abnormal 29.54 26.09 5 5745 4 1741027
Medication error 29.49 26.09 23 5727 4720 1736311
Hypoproteinaemia 29.24 26.09 10 5740 353 1740678
Pneumonia 29.16 26.09 73 5677 46109 1694922
Seronegative arthritis 29.10 26.09 7 5743 66 1740965
Xanthelasma 29.02 26.09 5 5745 5 1741026
Enteritis 28.82 26.09 13 5737 965 1740066
Asthma 28.81 26.09 23 5727 4881 1736150
Cerebral atrophy 28.76 26.09 12 5738 737 1740294
Disorientation 28.67 26.09 24 5726 5445 1735586
Eyelid oedema 28.10 26.09 14 5736 1299 1739732
Skin graft 27.94 26.09 8 5742 155 1740876
Lymphocyte stimulation test positive 27.74 26.09 9 5741 269 1740762
Red blood cell count decreased 27.64 26.09 20 5730 3666 1737365
Body temperature decreased 27.60 26.09 13 5737 1066 1739965
Dysphagia 27.47 26.09 31 5719 10137 1730894
Poor venous access 27.43 26.09 9 5741 279 1740752
Muscle swelling 27.41 26.09 7 5743 86 1740945
Poisoning deliberate 27.41 26.09 12 5738 830 1740201
Dermatitis allergic 27.37 26.09 13 5737 1086 1739945
Acquired haemophilia 27.25 26.09 8 5742 170 1740861
Chills 27.19 26.09 33 5717 11654 1729377
Haemoptysis 26.81 26.09 22 5728 4854 1736177
Laryngeal oedema 26.69 26.09 12 5738 884 1740147
Skin reaction 26.62 26.09 13 5737 1155 1739876
Haematoma 26.43 26.09 20 5730 3925 1737106

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 PE N0000008836 Decreased Prostaglandin Production
FDA Chemical/Ingredient N0000175721 Nonsteroidal Anti-inflammatory Compounds
FDA EPC N0000175722 Nonsteroidal Anti-inflammatory Drug
MeSH PA D000700 Analgesics
MeSH PA D018712 Analgesics, Non-Narcotic
CHEBI has role CHEBI:35481 non-narcotic analgesic
CHEBI has role CHEBI:35493 antipyretic
CHEBI has role CHEBI:88188 drug allergen
CHEBI has role CHEBI:35475 non-steroidal anti-inflammatory drug
MeSH PA D000893 Anti-Inflammatory Agents
MeSH PA D000894 Anti-Inflammatory Agents, Non-Steroidal
MeSH PA D018501 Antirheumatic Agents
MeSH PA D016861 Cyclooxygenase Inhibitors
MeSH PA D004791 Enzyme Inhibitors
MeSH PA D018373 Peripheral Nervous System Agents
MeSH PA D018689 Sensory System Agents

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)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
50MG CAMBIA ASSERTIO N022165 June 17, 2009 RX FOR SOLUTION ORAL 7759394 June 16, 2026 ACUTE TREATMENT OF MIGRAINE ATTACKS WITH OR WITHOUT AURA IN ADULTS
50MG CAMBIA ASSERTIO N022165 June 17, 2009 RX FOR SOLUTION ORAL 8097651 June 16, 2026 ACUTE TREATMENT OF MIGRAINE ATTACKS WITH OR WITHOUT AURA IN ADULTS
50MG CAMBIA ASSERTIO N022165 June 17, 2009 RX FOR SOLUTION ORAL 8927604 June 16, 2026 ACUTE TREATMENT OF MIGRAINE ATTACKS WITH OR WITHOUT AURA IN ADULTS
37.5MG/ML (37.5MG/ML) DYLOJECT JAVELIN PHARMS INC N022396 Dec. 23, 2014 DISCN SOLUTION INTRAVENOUS 8946292 March 22, 2027 MANAGEMENT OF PAIN
2% PENNSAID HORIZON N204623 Jan. 16, 2014 RX SOLUTION TOPICAL 8563613 Oct. 17, 2027 USE OF TOPICAL DICLOFENAC FOR TREATING PAIN
2% PENNSAID HORIZON N204623 Jan. 16, 2014 RX SOLUTION TOPICAL 8871809 Oct. 17, 2027 USE OF TOPICAL DICLOFENAC SODIUM FOR TREATING PAIN
2% PENNSAID HORIZON N204623 Jan. 16, 2014 RX SOLUTION TOPICAL 9066913 Oct. 17, 2027 USE OF TOPICAL DICLOFENAC FOR TREATING PAIN
2% PENNSAID HORIZON N204623 Jan. 16, 2014 RX SOLUTION TOPICAL 9101591 Oct. 17, 2027 USE OF TOPICAL DICLOFENAC FOR TREATING PAIN
2% PENNSAID HORIZON N204623 Jan. 16, 2014 RX SOLUTION TOPICAL 9132110 Oct. 17, 2027 USE OF TOPICAL DICLOFENAC FOR TREATING PAIN
2% PENNSAID HORIZON N204623 Jan. 16, 2014 RX SOLUTION TOPICAL 9168305 Oct. 17, 2027 USE OF TOPICAL DICLOFENAC FOR TREATING PAIN
2% PENNSAID HORIZON N204623 Jan. 16, 2014 RX SOLUTION TOPICAL 9220784 Oct. 17, 2027 USE OF TOPICAL DICLOFENAC FOR TREATING PAIN
2% PENNSAID HORIZON N204623 Jan. 16, 2014 RX SOLUTION TOPICAL 9339551 Oct. 17, 2027 USE OF TOPICAL DICLOFENAC FOR TREATING PAIN
2% PENNSAID HORIZON N204623 Jan. 16, 2014 RX SOLUTION TOPICAL 9339552 Oct. 17, 2027 USE OF TOPICAL DICLOFENAC FOR TREATING PAIN
2% PENNSAID HORIZON N204623 Jan. 16, 2014 RX SOLUTION TOPICAL 9539335 Oct. 17, 2027 USE OF TOPICAL DICLOFENAC SODIUM FOR TREATING PAIN
2% PENNSAID HORIZON N204623 Jan. 16, 2014 RX SOLUTION TOPICAL 8252838 April 21, 2028 USE OF TOPICAL DICLOFENAC ON A JOINT FOR TREATING OSTEOARTHRITIS
25MG ZIPSOR ASSERTIO N022202 June 16, 2009 RX CAPSULE ORAL 7662858 Feb. 24, 2029 NONSTEROIDAL ANTI-INFLAMMATORY DRUG INDICATED FOR RELIEF OF MILD TO MODERATE ACUTE PAIN
25MG ZIPSOR ASSERTIO N022202 June 16, 2009 RX CAPSULE ORAL 7884095 Feb. 24, 2029 NONSTEROIDAL ANTI-INFLAMMATORY DRUG INDICATED FOR RELIEF OF MILD TO MODERATE ACUTE PAIN
25MG ZIPSOR ASSERTIO N022202 June 16, 2009 RX CAPSULE ORAL 7939518 Feb. 24, 2029 NONSTEROIDAL ANTI-INFLAMMATORY DRUG INDICATED FOR RELIEF OF MILD TO MODERATE ACUTE PAIN
25MG ZIPSOR ASSERTIO N022202 June 16, 2009 RX CAPSULE ORAL 8110606 Feb. 24, 2029 NONSTEROIDAL ANTI-INFLAMMATORY DRUG INDICATED FOR RELIEF OF MILD TO MODERATE ACUTE PAIN
25MG ZIPSOR ASSERTIO N022202 June 16, 2009 RX CAPSULE ORAL 8623920 Feb. 24, 2029 DICLOFENAC POTASSIUM FOR RELIEF OF MILD TO MODERATE ACUTE PAIN
25MG ZIPSOR ASSERTIO N022202 June 16, 2009 RX CAPSULE ORAL 9561200 Feb. 24, 2029 DICLOFENAC POTASSIUM FOR RELIEF OF MILD TO MODERATE ACUTE PAIN
1.5% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** PENNSAID NUVO PHARMS INC N020947 Nov. 4, 2009 DISCN SOLUTION TOPICAL 8217078 July 10, 2029 USE OF TOPICAL DICLOFENAC ON THE KNEE AND A SECOND TOPICAL MEDICATION ON THE SAME KNEE
1.5% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** PENNSAID NUVO PHARMS INC N020947 Nov. 4, 2009 DISCN SOLUTION TOPICAL 8618164 July 10, 2029 USE OF TOPICAL DICLOFENAC ON THE KNEE AND A SECOND TOPICAL PRESCRIPTION MEDICATION ON THE SAME KNEE
1.5% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** PENNSAID NUVO PHARMS INC N020947 Nov. 4, 2009 DISCN SOLUTION TOPICAL 8741956 July 10, 2029 COMBINATION USE OF TOPICAL DICLOFENAC ON THE KNEE AND ADMINISTRATION OF AN ORAL NSAID.
2% PENNSAID HORIZON N204623 Jan. 16, 2014 RX SOLUTION TOPICAL 8217078 July 10, 2029 USE OF TOPICAL DICLOFENAC ON THE KNEE AND A SECOND TOPICAL PRESCRIPTION MEDICATION ON THE SAME KNEE
2% PENNSAID HORIZON N204623 Jan. 16, 2014 RX SOLUTION TOPICAL 8618164 July 10, 2029 USE OF TOPICAL DICLOFENAC ON THE KNEE AND A SECOND TOPICAL PRESCRIPTION MEDICATION ON THE SAME KNEE
2% PENNSAID HORIZON N204623 Jan. 16, 2014 RX SOLUTION TOPICAL 8741956 July 10, 2029 COMBINATION USE OF TOPICAL DICLOFENAC ON THE KNEE AND ADMINISTRATION OF AN ORAL NSAID.
2% PENNSAID HORIZON N204623 Jan. 16, 2014 RX SOLUTION TOPICAL 9370501 July 10, 2029 USE OF TOPICAL DICLOFENAC SODIUM FOR TREATING PAIN
2% PENNSAID HORIZON N204623 Jan. 16, 2014 RX SOLUTION TOPICAL 9375412 July 10, 2029 USE OF TOPICAL DICLOFENAC SODIUM FOR TREATING PAIN
2% PENNSAID HORIZON N204623 Jan. 16, 2014 RX SOLUTION TOPICAL 9415029 July 10, 2029 USE OF TOPICAL DICLOFENAC SODIUM FOR TREATING PAIN
18MG ZORVOLEX ZYLA N204592 Oct. 18, 2013 RX CAPSULE ORAL 8999387 April 23, 2030 TREATMENT OF PAIN
18MG ZORVOLEX ZYLA N204592 Oct. 18, 2013 RX CAPSULE ORAL 9180095 April 23, 2030 TREATMENT OF PAIN
18MG ZORVOLEX ZYLA N204592 Oct. 18, 2013 RX CAPSULE ORAL 9186328 April 23, 2030 TREATMENT OF PAIN
35MG ZORVOLEX ZYLA N204592 Oct. 18, 2013 RX CAPSULE ORAL 8999387 April 23, 2030 TREATMENT OF PAIN
35MG ZORVOLEX ZYLA N204592 Oct. 18, 2013 RX CAPSULE ORAL 9180095 April 23, 2030 TREATMENT OF PAIN
35MG ZORVOLEX ZYLA N204592 Oct. 18, 2013 RX CAPSULE ORAL 9186328 April 23, 2030 TREATMENT OF PAIN
1.5% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** PENNSAID NUVO PHARMS INC N020947 Nov. 4, 2009 DISCN SOLUTION TOPICAL 8546450 Aug. 9, 2030 COMBINATION USE OF TOPICAL DICLOFENAC ON THE KNEE AND ADMINISTRATION OF AN ORAL NSAID.
1.5% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** PENNSAID NUVO PHARMS INC N020947 Nov. 4, 2009 DISCN SOLUTION TOPICAL 8546450 Aug. 9, 2030 USE OF TOPICAL DICLOFENAC ON THE KNEE AND A SECOND TOPICAL AGENT SELECTED FROM SUNSCREEN AND INSECT REPELLANT
2% PENNSAID HORIZON N204623 Jan. 16, 2014 RX SOLUTION TOPICAL 8546450 Aug. 9, 2030 COMBINATION USE OF TOPICAL DICLOFENAC ON THE KNEE AND ADMINISTRATION OF AN ORAL NSAID.
2% PENNSAID HORIZON N204623 Jan. 16, 2014 RX SOLUTION TOPICAL 8546450 Aug. 9, 2030 USE OF TOPICAL DICLOFENAC ON THE KNEE AND A SECOND TOPICAL AGENT SELECTED FROM SUNSCREEN AND INSECT REPELLANT

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
1.3% LICART IBSA INST BIO N206976 Dec. 19, 2018 DISCN 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
D004008 MESH_DESCRIPTOR_UI
4019714 VUID
N0000147806 NUI
C0012091 UMLSCUI
D00903 KEGG_DRUG
144O8QL0L1 UNII
3270 INN_ID
78213-16-8 SECONDARY_CAS_RN
3355 RXNORM
7034005 SNOMEDCT_US
4582 MMSL
d00848 MMSL
363598004 SNOMEDCT_US
4019714 VANDF
004409 NDDF
CHEBI:47381 CHEBI
CHEMBL139 ChEMBL_ID
CHEMBL1034 ChEMBL_ID
C064142 MESH_SUPPLEMENTAL_RECORD_UI
DB00586 DRUGBANK_ID
CHEMBL1200804 ChEMBL_ID
DIF PDB_CHEM_ID
2714 IUPHAR_LIGAND_ID
3033 PUBCHEM_CID
CHEMBL1201180 ChEMBL_ID
C000614065 MESH_SUPPLEMENTAL_RECORD_UI

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
ARTHROTEC HUMAN PRESCRIPTION DRUG LABEL 2 0025-1411 TABLET, FILM COATED 50 mg ORAL NDA 20 sections
ARTHROTEC HUMAN PRESCRIPTION DRUG LABEL 2 0025-1421 TABLET, FILM COATED 75 mg ORAL NDA 20 sections
VOLTAREN HUMAN PRESCRIPTION DRUG LABEL 1 0078-0478 SOLUTION 1 mg OPHTHALMIC NDA 12 sections
Diclofenac Potassium HUMAN PRESCRIPTION DRUG LABEL 1 0093-0948 TABLET, FILM COATED 50 mg ORAL ANDA 13 sections
diclofenac epolamine HUMAN PRESCRIPTION DRUG LABEL 1 0093-3225 PATCH 0.01 g TOPICAL NDA authorized generic 20 sections
diclofenac epolamine HUMAN PRESCRIPTION DRUG LABEL 1 0093-3727 SYSTEM 0.01 g TOPICAL NDA AUTHORIZED GENERIC 20 sections
Diclofenac Sodium HUMAN PRESCRIPTION DRUG LABEL 1 0115-1483 GEL 30 mg TOPICAL ANDA 15 sections
DICLOFENAC SODIUM HUMAN PRESCRIPTION DRUG LABEL 1 0168-0803 GEL 30 mg TOPICAL NDA authorized generic 15 sections
DICLOFENAC SODIUM HUMAN PRESCRIPTION DRUG LABEL 1 0168-0844 GEL 30 mg TOPICAL NDA authorized generic 15 sections
Diclofenac Sodium HUMAN PRESCRIPTION DRUG LABEL 1 0228-2550 TABLET, DELAYED RELEASE 50 mg ORAL ANDA 13 sections
Diclofenac Sodium HUMAN PRESCRIPTION DRUG LABEL 1 0228-2551 TABLET, DELAYED RELEASE 75 mg ORAL ANDA 13 sections
Diclofenac Potassium HUMAN PRESCRIPTION DRUG LABEL 1 0378-2474 TABLET, FILM COATED 50 mg ORAL ANDA 13 sections
Diclofenac Sodium HUMAN PRESCRIPTION DRUG LABEL 1 0378-6280 TABLET, DELAYED RELEASE 50 mg ORAL ANDA 13 sections
Diclofenac Sodium HUMAN PRESCRIPTION DRUG LABEL 1 0378-6281 TABLET, DELAYED RELEASE 75 mg ORAL ANDA 13 sections
Diclofenac Sodium HUMAN PRESCRIPTION DRUG LABEL 1 0378-8750 GEL 10 mg TOPICAL ANDA 18 sections
Diclofenac Sodium HUMAN PRESCRIPTION DRUG LABEL 1 0472-1783 GEL 30 mg TOPICAL ANDA 15 sections
Diclofenac Sodium HUMAN PRESCRIPTION DRUG LABEL 1 0527-2170 TABLET, EXTENDED RELEASE 100 mg ORAL ANDA 13 sections
Diclofenac Sodium and Misoprostol HUMAN PRESCRIPTION DRUG LABEL 2 0591-0397 TABLET, DELAYED RELEASE 50 mg ORAL ANDA 19 sections
Diclofenac Sodium and Misoprostol HUMAN PRESCRIPTION DRUG LABEL 2 0591-0398 TABLET, DELAYED RELEASE 75 mg ORAL ANDA 19 sections
diclofenac sodium HUMAN PRESCRIPTION DRUG LABEL 1 0615-4506 TABLET, DELAYED RELEASE 50 mg ORAL ANDA 13 sections
diclofenac sodium HUMAN PRESCRIPTION DRUG LABEL 1 0615-4507 TABLET, DELAYED RELEASE 75 mg ORAL ANDA 13 sections
Diclofenac Sodium HUMAN PRESCRIPTION DRUG LABEL 1 0781-1381 TABLET, FILM COATED, EXTENDED RELEASE 100 mg ORAL NDA AUTHORIZED GENERIC 14 sections
Diclofenac Potassium HUMAN PRESCRIPTION DRUG LABEL 1 0781-5017 TABLET, FILM COATED 50 mg ORAL ANDA 14 sections
Solaraze HUMAN PRESCRIPTION DRUG LABEL 1 10337-803 GEL 30 mg TOPICAL NDA 15 sections
Solaraze HUMAN PRESCRIPTION DRUG LABEL 1 10337-844 GEL 30 mg TOPICAL NDA 15 sections
Diclofenac Sodium HUMAN PRESCRIPTION DRUG LABEL 1 10544-114 TABLET, DELAYED RELEASE 50 mg ORAL ANDA 13 sections
Diclofenac Sodium HUMAN PRESCRIPTION DRUG LABEL 1 10544-188 TABLET, DELAYED RELEASE 50 mg ORAL ANDA 14 sections
Diclofenac Sodium HUMAN PRESCRIPTION DRUG LABEL 1 10544-189 TABLET, DELAYED RELEASE 75 mg ORAL ANDA 14 sections
Diclofenac Sodium HUMAN PRESCRIPTION DRUG LABEL 1 10544-921 TABLET, DELAYED RELEASE 75 mg ORAL ANDA 13 sections
Diclofenac Sodium HUMAN PRESCRIPTION DRUG LABEL 1 10544-923 TABLET, DELAYED RELEASE 50 mg ORAL ANDA 13 sections