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

Stem definitionDrug idCAS RN
1883 22204-53-1

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • methoxypropiocin
  • naproxen
  • naprosyn
  • aproxen
  • naproxen sodium
  • aleve
An anti-inflammatory agent with analgesic and antipyretic properties. Both the acid and its sodium salt are used in the treatment of rheumatoid arthritis and other rheumatic or musculoskeletal disorders, dysmenorrhea, and acute gout.
  • Molecular weight: 230.26
  • Formula: C14H14O3
  • CLOGP: 2.82
  • LIPINSKI: 0
  • HAC: 3
  • HDO: 1
  • TPSA: 46.53
  • ALOGS: -3.65
  • ROTB: 3

  • Status: OFP

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

Drug dosage:

DoseUnitRoute
0.50 g O
0.50 g R
0.50 g O

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 2 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 0.12 mg/mL Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 0.50 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 108.57 ┬ÁM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 99 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution) 0.09 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 0.07 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.00 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 16.63 hours Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
March 11, 1976 FDA ROCHE PALO

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 2294.08 27.73 770 4993 45873 2306449
Drug ineffective 1418.10 27.73 678 5085 100946 2251376
Completed suicide 1205.39 27.73 393 5370 20641 2331681
Pharyngitis 926.22 27.73 201 5562 2034 2350288
Toxicity to various agents 856.51 27.73 343 5420 32411 2319911
Nausea 800.44 27.73 482 5281 111707 2240615
Vomiting 754.21 27.73 398 5365 71204 2281118
Dizziness 744.56 27.73 370 5393 58295 2294027
Pain 740.69 27.73 375 5388 61482 2290840
Synovitis 705.22 27.73 167 5596 2559 2349763
Rash 602.65 27.73 323 5440 59235 2293087
Arthropathy 593.23 27.73 179 5584 7137 2345185
Ear infection 577.61 27.73 149 5614 3292 2349030
Headache 574.94 27.73 347 5416 79832 2272490
Acute kidney injury 569.51 27.73 246 5517 27876 2324446
Rheumatoid arthritis 556.29 27.73 217 5546 18923 2333399
Abdominal discomfort 535.93 27.73 206 5557 17250 2335072
Deafness transitory 530.13 27.73 85 5678 98 2352224
Gastrointestinal pain 488.63 27.73 105 5658 1001 2351321
Weight decreased 480.21 27.73 219 5544 28152 2324170
C-reactive protein abnormal 469.21 27.73 96 5667 703 2351619
Arthralgia 461.65 27.73 263 5500 54022 2298300
Gastrointestinal haemorrhage 458.66 27.73 168 5595 12267 2340055
Abdominal pain upper 442.38 27.73 192 5571 21908 2330414
Red blood cell sedimentation rate abnormal 434.80 27.73 84 5679 439 2351883
Condition aggravated 421.92 27.73 208 5555 31771 2320551
Decreased appetite 417.43 27.73 200 5563 28691 2323631
Gastric ulcer 397.94 27.73 108 5655 2908 2349414
Fatigue 386.02 27.73 277 5486 84596 2267726
Abdominal pain 367.26 27.73 194 5569 34180 2318142
Drug intolerance 357.53 27.73 144 5619 13573 2338749
Osteoporosis 357.27 27.73 108 5655 4306 2348016
Haematemesis 356.86 27.73 106 5657 3976 2348346
Shoulder arthroplasty 344.29 27.73 66 5697 328 2351994
Intentional overdose 341.05 27.73 132 5631 11189 2341133
Pain in extremity 325.94 27.73 193 5570 42347 2309975
Deafness 306.71 27.73 86 5677 2615 2349707
Haemoglobin decreased 293.42 27.73 136 5627 18015 2334307
Contraindicated product administered 288.31 27.73 84 5679 2937 2349385
Hypophagia 281.74 27.73 88 5675 3912 2348410
Femur fracture 258.98 27.73 94 5669 6645 2345677
Anaphylactic reaction 256.47 27.73 103 5660 9602 2342720
Dyspnoea 253.94 27.73 210 5553 78523 2273799
Joint swelling 247.01 27.73 118 5645 16701 2335621
Fall 246.29 27.73 168 5595 46931 2305391
Gastrointestinal disorder 243.80 27.73 97 5666 8820 2343502
Musculoskeletal stiffness 239.84 27.73 105 5658 12142 2340180
Musculoskeletal pain 235.52 27.73 100 5663 10730 2341592
Toothache 232.42 27.73 69 5694 2575 2349747
Overdose 231.03 27.73 119 5644 19788 2332534
Malaise 223.47 27.73 169 5594 55416 2296906
Diarrhoea 222.85 27.73 200 5563 83364 2268958
Urticaria 222.53 27.73 124 5639 24137 2328185
Hypoaesthesia 220.71 27.73 116 5647 20099 2332223
Swelling 216.81 27.73 107 5656 16243 2336079
Suicide attempt 215.28 27.73 95 5668 11187 2341135
Foot operation 214.64 27.73 50 5713 703 2351619
Pruritus 208.58 27.73 147 5616 43193 2309129
Upper gastrointestinal haemorrhage 208.16 27.73 60 5703 2014 2350308
Infection 206.91 27.73 107 5656 17922 2334400
Somnolence 204.39 27.73 116 5647 23369 2328953
Hypersensitivity 203.90 27.73 116 5647 23477 2328845
Therapeutic product effect decreased 203.10 27.73 90 5673 10699 2341623
Melaena 202.53 27.73 69 5694 4037 2348285
Peripheral swelling 200.67 27.73 104 5659 17493 2334829
Hypotension 199.08 27.73 128 5635 32308 2320014
Gastritis 198.96 27.73 70 5693 4511 2347811
Cardiac arrest 195.80 27.73 97 5666 14833 2337489
Respiratory arrest 192.77 27.73 74 5689 6104 2346218
Feeding disorder 191.14 27.73 52 5711 1406 2350916
Body height below normal 184.76 27.73 32 5731 77 2352245
Human antichimeric antibody positive 184.60 27.73 28 5735 14 2352308
Lower respiratory tract infection 180.13 27.73 68 5695 5356 2346966
Musculoskeletal disorder 179.51 27.73 56 5707 2472 2349850
Synovial fluid analysis 177.38 27.73 26 5737 5 2352317
Nephrolithiasis 176.79 27.73 64 5699 4479 2347843
Impaired work ability 175.57 27.73 51 5712 1759 2350563
Duodenal ulcer 174.97 27.73 46 5717 1087 2351235
Swelling face 174.81 27.73 78 5685 9415 2342907
Joint laxity 173.71 27.73 28 5735 34 2352288
Nerve injury 171.18 27.73 45 5718 1063 2351259
C-reactive protein increased 170.71 27.73 68 5695 6187 2346135
Flank pain 169.87 27.73 48 5715 1497 2350825
Ulcer 169.27 27.73 50 5713 1830 2350492
Haematochezia 167.23 27.73 64 5699 5231 2347091
Wheezing 165.91 27.73 67 5696 6317 2346005
Obesity 161.11 27.73 46 5717 1490 2350832
Tenosynovitis stenosans 158.39 27.73 29 5734 106 2352216
Adrenal insufficiency 156.20 27.73 44 5719 1356 2350966
Anaemia 155.65 27.73 113 5650 34679 2317643
Dyspepsia 150.23 27.73 71 5692 9773 2342549
Atrial fibrillation 150.08 27.73 79 5684 13689 2338633
Gait inability 149.59 27.73 61 5702 5894 2346428
Cardio-respiratory arrest 148.95 27.73 69 5694 9077 2343245
Poisoning 145.35 27.73 49 5714 2771 2349551
Impaired healing 137.86 27.73 56 5707 5355 2346967
Erythema 136.45 27.73 92 5671 25067 2327255
Metabolic acidosis 135.63 27.73 57 5706 5941 2346381
Scleritis 134.52 27.73 29 5734 279 2352043
Gastric ulcer haemorrhage 134.00 27.73 35 5728 805 2351517
Haematocrit decreased 132.06 27.73 51 5712 4267 2348055
Muscle spasms 131.83 27.73 85 5678 21481 2330841
Cushingoid 129.82 27.73 32 5731 578 2351744
Rheumatoid nodule 129.41 27.73 32 5731 586 2351736
Red blood cell count decreased 129.10 27.73 50 5713 4216 2348106
Joint effusion 128.38 27.73 37 5726 1239 2351083
Functional gastrointestinal disorder 127.56 27.73 30 5733 440 2351882
Product use issue 127.43 27.73 68 5695 12101 2340221
Fibromyalgia 126.52 27.73 46 5717 3254 2349068
Paraesthesia 125.10 27.73 83 5680 22005 2330317
Toxic epidermal necrolysis 124.93 27.73 45 5718 3099 2349223
Synovial cyst 123.26 27.73 33 5730 837 2351485
Gastrooesophageal reflux disease 121.81 27.73 60 5703 9035 2343287
Angioedema 117.26 27.73 57 5706 8339 2343983
Crepitations 117.16 27.73 30 5733 636 2351686
Arthritis 116.60 27.73 60 5703 9908 2342414
Bursitis 113.70 27.73 37 5726 1871 2350451
Feeling jittery 113.25 27.73 37 5726 1895 2350427
Pleuritic pain 112.94 27.73 29 5734 622 2351700
Renal failure 112.50 27.73 71 5692 17278 2335044
Asthenia 112.20 27.73 106 5657 46820 2305502
Foot deformity 112.19 27.73 37 5726 1952 2350370
Juvenile idiopathic arthritis 112.14 27.73 27 5736 440 2351882
Adverse reaction 112.05 27.73 35 5728 1549 2350773
Mobility decreased 111.70 27.73 56 5707 8754 2343568
Loss of consciousness 109.83 27.73 72 5691 18695 2333627
Polyarthritis 109.01 27.73 30 5733 846 2351476
Loss of personal independence in daily activities 108.57 27.73 47 5716 5264 2347058
Ocular hyperaemia 106.81 27.73 43 5720 4013 2348309
Lip swelling 106.25 27.73 45 5718 4776 2347546
Back pain 104.65 27.73 86 5677 31573 2320749
Drug interaction 104.39 27.73 83 5680 29080 2323242
Bone density decreased 104.19 27.73 32 5731 1338 2350984
Gastric disorder 103.49 27.73 41 5722 3669 2348653
Depression 102.70 27.73 81 5682 28051 2324271
Chest pain 102.68 27.73 81 5682 28056 2324266
Tenderness 101.48 27.73 34 5729 1884 2350438
Dry mouth 100.34 27.73 51 5712 8202 2344120
Loose body in joint 99.01 27.73 17 5746 38 2352284
Antinuclear antibody positive 98.35 27.73 29 5734 1053 2351269
Off label use 97.99 27.73 122 5641 73476 2278846
Mouth ulceration 97.95 27.73 40 5723 3872 2348450
Intestinal diaphragm disease 97.30 27.73 16 5747 24 2352298
Blood pressure increased 96.53 27.73 64 5699 16922 2335400
Photophobia 95.59 27.73 34 5729 2255 2350067
Duodenal ulcer haemorrhage 94.60 27.73 23 5740 391 2351931
Joint destruction 94.02 27.73 22 5741 315 2352007
Visual impairment 93.88 27.73 55 5708 11700 2340622
Bone disorder 90.49 27.73 36 5727 3256 2349066
Tubulointerstitial nephritis 89.78 27.73 33 5730 2405 2349917
Pseudoporphyria 89.54 27.73 16 5747 49 2352273
Eye pain 89.35 27.73 40 5723 4851 2347471
Atelectasis 88.98 27.73 31 5732 1934 2350388
Nodule 88.94 27.73 32 5731 2194 2350128
Multiple fractures 88.80 27.73 24 5739 631 2351691
Occult blood positive 88.66 27.73 23 5740 514 2351808
Death 86.70 27.73 121 5642 81347 2270975
Conjunctivitis 86.68 27.73 32 5731 2361 2349961
Red blood cell sedimentation rate increased 86.43 27.73 31 5732 2106 2350216
Gastric haemorrhage 85.58 27.73 26 5737 1047 2351275
Intentional product misuse 85.40 27.73 48 5715 9441 2342881
Hypertension 83.49 27.73 71 5692 27290 2325032
Faeces discoloured 83.44 27.73 31 5732 2328 2349994
Adverse drug reaction 83.06 27.73 45 5718 8238 2344084
Serum sickness-like reaction 79.75 27.73 16 5747 104 2352218
Insomnia 78.84 27.73 67 5696 25720 2326602
Chest discomfort 78.12 27.73 53 5710 14542 2337780
Osteoporotic fracture 76.91 27.73 19 5744 346 2351976
Tremor 76.44 27.73 60 5703 20601 2331721
Septic shock 75.42 27.73 40 5723 7014 2345308
Eye irritation 74.78 27.73 32 5731 3480 2348842
Weight increased 74.41 27.73 61 5702 22276 2330046
Dry eye 74.32 27.73 33 5730 3923 2348399
Abnormal loss of weight 73.99 27.73 21 5742 664 2351658
Interstitial lung disease 71.59 27.73 40 5723 7772 2344550
Swollen tongue 70.75 27.73 35 5728 5308 2347014
Drug eruption 70.40 27.73 30 5733 3229 2349093
Confusional state 69.83 27.73 61 5702 24283 2328039
Pneumonia 69.15 27.73 84 5679 49212 2303110
Stevens-Johnson syndrome 68.86 27.73 32 5731 4227 2348095
Anaphylactic shock 68.67 27.73 32 5731 4254 2348068
Suicidal ideation 68.39 27.73 44 5719 11043 2341279
Tachycardia 68.02 27.73 51 5712 16358 2335964
Kounis syndrome 67.31 27.73 16 5747 246 2352076
Hyperhidrosis 66.31 27.73 49 5714 15373 2336949
Electrocardiogram QT prolonged 66.18 27.73 38 5725 7776 2344546
Gastritis erosive 65.64 27.73 20 5743 813 2351509
Asthma 65.13 27.73 43 5720 11271 2341051
Hiatus hernia 65.06 27.73 25 5738 2059 2350263
Iron deficiency anaemia 64.89 27.73 25 5738 2074 2350248
Gastrointestinal sounds abnormal 63.79 27.73 18 5745 557 2351765
Bunion operation 63.64 27.73 14 5749 149 2352173
Oesophageal ulcer 63.54 27.73 19 5744 724 2351598
Pyrexia 63.42 27.73 84 5679 53624 2298698
Neoplasm malignant 63.42 27.73 32 5731 5061 2347261
Blood loss anaemia 63.36 27.73 21 5742 1124 2351198
Infusion related reaction 63.20 27.73 40 5723 9756 2342566
Thrombosis 63.18 27.73 39 5724 9105 2343217
Constipation 61.62 27.73 54 5709 21575 2330747
Extra dose administered 61.53 27.73 21 5742 1230 2351092
Therapeutic response decreased 60.96 27.73 35 5728 7160 2345162
Drug specific antibody 60.92 27.73 12 5751 70 2352252
Bezoar 59.91 27.73 14 5749 199 2352123
Urinary tract infection 59.08 27.73 61 5702 29881 2322441
Respiratory tract congestion 58.48 27.73 24 5739 2350 2349972
Syncope 58.10 27.73 47 5716 16828 2335494
Feeling abnormal 57.61 27.73 54 5709 23527 2328795
Lung disorder 57.44 27.73 32 5731 6180 2346142
Incorrect dosage administered 56.25 27.73 15 5748 374 2351948
Pulmonary congestion 55.77 27.73 22 5741 1943 2350379
Cough 55.71 27.73 62 5701 33055 2319267
Serotonin syndrome 55.37 27.73 26 5737 3514 2348808
Leukocytosis 55.12 27.73 26 5737 3550 2348772
Intentional self-injury 54.53 27.73 27 5736 4100 2348222
Urinary retention 54.50 27.73 26 5737 3641 2348681
Heart rate decreased 54.44 27.73 26 5737 3650 2348672
Haemorrhage 54.13 27.73 38 5725 11001 2341321
Contusion 53.48 27.73 40 5723 12770 2339552
Inflammation 52.03 27.73 30 5733 6183 2346139
Hepatic failure 51.76 27.73 29 5734 5660 2346662
Oedema peripheral 51.59 27.73 51 5712 23712 2328610
Pain in jaw 51.33 27.73 30 5733 6342 2345980
Epistaxis 51.08 27.73 35 5728 9744 2342578
Vision blurred 50.80 27.73 41 5722 14627 2337695
Sinus tachycardia 50.71 27.73 24 5739 3301 2349021
Antibody test positive 50.43 27.73 13 5750 283 2352039
Blister 49.64 27.73 30 5733 6741 2345581
Accidental exposure to product by child 49.55 27.73 15 5748 596 2351726
Hypersensitivity vasculitis 49.32 27.73 18 5745 1284 2351038
Wheelchair user 49.28 27.73 14 5749 444 2351878
Disability 49.01 27.73 16 5747 816 2351506
Depressed level of consciousness 48.92 27.73 31 5732 7573 2344749
Hyperkalaemia 48.14 27.73 28 5735 5865 2346457
Unresponsive to stimuli 47.49 27.73 26 5737 4850 2347472
Agitation 47.23 27.73 35 5728 11016 2341306
Heart rate increased 47.08 27.73 35 5728 11070 2341252
Throat tightness 46.96 27.73 25 5738 4411 2347911
Mental status changes 46.87 27.73 27 5736 5555 2346767
Peritonitis 46.83 27.73 21 5742 2553 2349769
Mydriasis 46.51 27.73 20 5743 2199 2350123
Osteoarthritis 46.39 27.73 29 5734 6917 2345405
Discomfort 46.12 27.73 26 5737 5133 2347189
Depressed mood 45.94 27.73 26 5737 5172 2347150
Colitis ischaemic 45.31 27.73 18 5745 1619 2350703
Oesophagitis 45.09 27.73 19 5744 1987 2350335
Flushing 45.00 27.73 35 5728 11836 2340486
International normalised ratio increased 44.94 27.73 29 5734 7307 2345015
Obstructive airways disorder 44.75 27.73 17 5746 1356 2350966
Dysarthria 43.83 27.73 27 5736 6275 2346047
Rectal haemorrhage 43.06 27.73 26 5737 5830 2346492
Eating disorder 42.74 27.73 19 5744 2262 2350060
Dysphagia 42.66 27.73 35 5728 12770 2339552
Rhabdomyolysis 42.30 27.73 27 5736 6677 2345645
Expired product administered 42.22 27.73 16 5747 1268 2351054
Medication error 41.96 27.73 26 5737 6105 2346217
Migraine 41.66 27.73 32 5731 10621 2341701
Eye swelling 41.63 27.73 23 5740 4367 2347955
Sedation 41.48 27.73 21 5742 3341 2348981
Immunodeficiency 41.22 27.73 15 5748 1061 2351261
Blood pressure decreased 41.15 27.73 30 5733 9206 2343116
Palpitations 40.77 27.73 38 5725 16418 2335904
Skin exfoliation 40.76 27.73 25 5738 5765 2346557
Hot flush 40.54 27.73 27 5736 7172 2345150
Therapy non-responder 39.96 27.73 28 5735 8076 2344246
Blood creatinine increased 39.80 27.73 31 5732 10502 2341820
Psoriasis 39.70 27.73 38 5725 16970 2335352
Miosis 39.34 27.73 15 5748 1209 2351113
Microcytic anaemia 39.32 27.73 12 5751 490 2351832
Large intestinal ulcer 39.21 27.73 12 5751 495 2351827
Gastrointestinal ulcer 39.11 27.73 11 5752 336 2351986
Ecchymosis 38.97 27.73 16 5747 1567 2350755
Knee arthroplasty 38.17 27.73 19 5744 2916 2349406
Myalgia 38.03 27.73 43 5720 23290 2329032
Spinal pain 37.96 27.73 15 5748 1330 2350992
Mucosal inflammation 37.91 27.73 23 5740 5201 2347121
Pharyngeal oedema 37.86 27.73 20 5743 3473 2348849
Hypokalaemia 37.34 27.73 30 5733 10624 2341698
Coma 37.17 27.73 28 5735 9028 2343294
Oxygen saturation decreased 36.91 27.73 26 5737 7560 2344762
Nasopharyngitis 36.55 27.73 41 5722 22015 2330307
Haematuria 36.55 27.73 21 5742 4297 2348025
Blood pressure fluctuation 36.36 27.73 16 5747 1859 2350463
Immune thrombocytopenic purpura 36.34 27.73 15 5748 1489 2350833
Anxiety 36.25 27.73 47 5716 29312 2323010
Movement disorder 35.87 27.73 18 5745 2810 2349512
Amnesia 35.62 27.73 25 5738 7228 2345094
Carpal tunnel syndrome 35.18 27.73 16 5747 2009 2350313
Pleural effusion 34.95 27.73 30 5733 11638 2340684
Duodenitis 34.89 27.73 11 5752 501 2351821
Suicidal behaviour 34.70 27.73 11 5752 510 2351812
Oedema 34.21 27.73 28 5735 10175 2342147
Anti-transglutaminase antibody 34.07 27.73 5 5758 1 2352321
Drug-induced liver injury 34.03 27.73 19 5744 3680 2348642
Abdominal distension 33.72 27.73 28 5735 10383 2341939
Exposure during pregnancy 33.70 27.73 42 5721 25177 2327145
Hyperthermia 33.31 27.73 14 5749 1454 2350868
Pulmonary oedema 32.99 27.73 24 5739 7339 2344983
Myasthenia gravis 32.78 27.73 11 5752 611 2351711
Liver function test abnormal 32.62 27.73 24 5739 7466 2344856
Gait disturbance 32.48 27.73 39 5724 22506 2329816
Coordination abnormal 32.32 27.73 15 5748 1973 2350349
Renal tubular necrosis 32.23 27.73 14 5749 1576 2350746
Serum ferritin abnormal 32.13 27.73 6 5757 25 2352297
Gastroenteritis viral 31.76 27.73 16 5747 2518 2349804
Treatment noncompliance 31.75 27.73 21 5742 5513 2346809
Incorrect dose administered 31.24 27.73 26 5737 9669 2342653
Adrenergic syndrome 31.04 27.73 5 5758 6 2352316
Hepatic enzyme increased 30.99 27.73 26 5737 9776 2342546
Smear cervix abnormal 30.91 27.73 9 5754 312 2352010
Hallucination 30.82 27.73 24 5739 8124 2344198
Abdominal tenderness 30.69 27.73 12 5751 1035 2351287
Duodenal ulcer perforation 30.53 27.73 9 5754 326 2351996
Muscular weakness 30.52 27.73 31 5732 14866 2337456
Dactylitis 30.19 27.73 7 5756 96 2352226
Analgesic drug level above therapeutic 30.17 27.73 6 5757 37 2352285
Hepatic necrosis 30.01 27.73 12 5751 1098 2351224
Proteinuria 29.99 27.73 16 5747 2834 2349488
Hypoaldosteronism 29.77 27.73 6 5757 40 2352282
Glossodynia 29.53 27.73 14 5749 1931 2350391
Ulcer haemorrhage 29.47 27.73 10 5753 575 2351747
Myoclonus 29.15 27.73 15 5748 2468 2349854
Bronchitis 28.94 27.73 29 5734 13685 2338637
Pallor 28.51 27.73 17 5746 3725 2348597
Shock haemorrhagic 28.33 27.73 12 5751 1271 2351051
Cellulitis 28.25 27.73 24 5739 9177 2343145
Meningitis aseptic 28.10 27.73 10 5753 663 2351659
Limb deformity 27.91 27.73 8 5755 262 2352060
Gastritis haemorrhagic 27.91 27.73 8 5755 262 2352060

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
Completed suicide 823.15 29.53 285 3635 16027 1726834
Gastrointestinal haemorrhage 816.41 29.53 274 3646 13993 1728868
Acute kidney injury 695.51 29.53 311 3609 34633 1708228
Gastric haemorrhage 672.19 29.53 167 3753 2811 1740050
Drug hypersensitivity 429.15 29.53 174 3746 14961 1727900
Melaena 414.21 29.53 129 3791 5081 1737780
Toxicity to various agents 409.77 29.53 205 3715 28936 1713925
Duodenal ulcer 402.95 29.53 100 3820 1660 1741201
Upper gastrointestinal haemorrhage 386.45 29.53 108 3812 2891 1739970
Haematemesis 333.56 29.53 105 3815 4272 1738589
Gastric ulcer 310.95 29.53 89 3831 2596 1740265
Faeces discoloured 293.27 29.53 83 3837 2321 1740540
Haemoglobin decreased 271.22 29.53 131 3789 16983 1725878
Anaemia 263.95 29.53 154 3766 29303 1713558
Nausea 234.69 29.53 176 3744 51020 1691841
Dizziness 219.74 29.53 145 3775 34216 1708645
Respiratory arrest 210.01 29.53 80 3840 5759 1737102
Drug ineffective 204.60 29.53 178 3742 63623 1679238
Hypotension 198.85 29.53 129 3791 29525 1713336
Angioedema 186.80 29.53 85 3835 9579 1733282
Duodenal ulcer haemorrhage 181.87 29.53 45 3875 732 1742129
Abdominal pain 175.39 29.53 106 3814 21384 1721477
Arthralgia 174.44 29.53 109 3811 23335 1719526
Overdose 166.94 29.53 94 3826 16607 1726254
Gastritis 165.54 29.53 57 3863 3060 1739801
Blood creatinine increased 162.83 29.53 87 3833 13859 1729002
Rheumatoid arthritis 161.83 29.53 62 3858 4523 1738338
Dyspnoea 155.94 29.53 140 3780 51919 1690942
Milk-alkali syndrome 155.51 29.53 27 3893 56 1742805
Cardiac arrest 151.99 29.53 87 3833 15843 1727018
Vomiting 151.53 29.53 121 3799 38194 1704667
Rectal haemorrhage 150.43 29.53 62 3858 5480 1737381
Hyperkalaemia 145.85 29.53 69 3851 8478 1734383
Joint swelling 145.54 29.53 63 3857 6290 1736571
Abdominal pain upper 143.65 29.53 74 3846 10927 1731934
Urticaria 141.81 29.53 76 3844 12165 1730696
Suicide attempt 133.35 29.53 62 3858 7319 1735542
Lip swelling 132.58 29.53 47 3873 2748 1740113
Abdominal discomfort 129.93 29.53 65 3855 9016 1733845
Pain 128.94 29.53 95 3825 26562 1716299
Rash 125.46 29.53 109 3811 38584 1704277
Asthenia 125.36 29.53 104 3816 34566 1708295
Pallor 119.86 29.53 46 3874 3365 1739496
Intentional overdose 118.91 29.53 58 3862 7612 1735249
Acne cystic 116.70 29.53 21 3899 58 1742803
Haematochezia 116.49 29.53 50 3870 4882 1737979
Gastritis erosive 116.01 29.53 33 3887 934 1741927
Peripheral swelling 110.89 29.53 56 3864 7915 1734946
Pain in extremity 110.46 29.53 75 3845 18397 1724464
Haematocrit decreased 109.82 29.53 46 3874 4227 1738634
Drug interaction 109.65 29.53 88 3832 27870 1714991
Disability 104.43 29.53 27 3893 527 1742334
Contraindicated product administered 102.96 29.53 33 3887 1411 1741450
Gastric ulcer haemorrhage 101.67 29.53 30 3890 969 1741892
Condition aggravated 99.05 29.53 74 3846 21076 1721785
Peptic ulcer 91.94 29.53 24 3896 487 1742374
Accidental exposure to product by child 91.04 29.53 26 3894 746 1742115
Pruritus 90.77 29.53 73 3847 23149 1719712
Infection 90.47 29.53 57 3863 12303 1730558
Loss of personal independence in daily activities 90.18 29.53 34 3886 2365 1740496
Blood urea increased 89.47 29.53 41 3879 4670 1738191
Stevens-Johnson syndrome 85.77 29.53 36 3884 3321 1739540
Drug intolerance 85.48 29.53 43 3877 6019 1736842
Diarrhoea 83.39 29.53 102 3818 53750 1689111
Tubulointerstitial nephritis 83.27 29.53 34 3886 2924 1739937
Glomerulonephritis membranous 81.41 29.53 19 3901 237 1742624
Constipation 80.42 29.53 57 3863 14943 1727918
Tachycardia 79.53 29.53 53 3867 12575 1730286
Anaphylactic reaction 79.32 29.53 41 3879 6072 1736789
Cardio-respiratory arrest 78.55 29.53 47 3873 9246 1733615
Haemorrhage 76.11 29.53 47 3873 9782 1733079
Metabolic acidosis 75.21 29.53 38 3882 5364 1737497
Insomnia 74.02 29.53 56 3864 16220 1726641
Metabolic alkalosis 72.48 29.53 17 3903 217 1742644
Fatigue 70.29 29.53 91 3829 50690 1692171
International normalised ratio increased 70.19 29.53 42 3878 8257 1734604
Chest pain 68.15 29.53 58 3862 19856 1723005
Oesophagitis 67.17 29.53 25 3895 1676 1741185
Dyspepsia 66.29 29.53 34 3886 4951 1737910
Malaise 66.24 29.53 68 3852 29497 1713364
Hypersensitivity vasculitis 64.14 29.53 22 3898 1162 1741699
Back disorder 64.08 29.53 21 3899 963 1741898
Neck mass 63.00 29.53 15 3905 205 1742656
Erythema 62.69 29.53 48 3872 14140 1728721
Impaired work ability 61.54 29.53 21 3899 1092 1741769
Steatorrhoea 61.03 29.53 13 3907 103 1742758
Ankylosing spondylitis 60.13 29.53 19 3901 774 1742087
Renal tubular necrosis 58.41 29.53 24 3896 2095 1740766
Swollen tongue 58.24 29.53 26 3894 2782 1740079
Duodenal ulcer perforation 57.89 29.53 15 3905 295 1742566
Renal failure 57.88 29.53 53 3867 19964 1722897
Heart rate increased 57.79 29.53 34 3886 6476 1736385
Hypercalcaemia 57.62 29.53 23 3897 1863 1740998
Occult blood positive 57.47 29.53 17 3903 553 1742308
Lethargy 57.24 29.53 35 3885 7149 1735712
Hypersensitivity 56.65 29.53 40 3880 10404 1732457
Rash pruritic 56.33 29.53 29 3891 4253 1738608
Hand deformity 56.28 29.53 14 3906 232 1742629
Diverticular perforation 55.84 29.53 16 3904 464 1742397
Epistaxis 55.01 29.53 36 3884 8270 1734591
Poisoning 54.29 29.53 24 3896 2508 1740353
Back pain 53.99 29.53 47 3873 16566 1726295
Cough 53.89 29.53 50 3870 19147 1723714
Incorrect dosage administered 53.66 29.53 13 3907 192 1742669
Decreased appetite 53.59 29.53 55 3865 23816 1719045
Ulcer 52.87 29.53 19 3901 1152 1741709
Hepatic enzyme increased 52.08 29.53 32 3888 6589 1736272
Syncope 52.01 29.53 43 3877 14126 1728735
Somnolence 51.68 29.53 46 3874 16693 1726168
Hiatus hernia 51.48 29.53 18 3902 1007 1741854
Gastrointestinal fistula 48.81 29.53 11 3909 116 1742745
Renal impairment 48.62 29.53 39 3881 12275 1730586
Kounis syndrome 48.31 29.53 14 3906 423 1742438
Musculoskeletal stiffness 47.75 29.53 29 3891 5847 1737014
Chronic kidney disease 47.62 29.53 26 3894 4291 1738570
Thrombocytosis 47.30 29.53 15 3905 618 1742243
Gangrene neonatal 47.22 29.53 7 3913 1 1742860
Oesophageal ulcer 47.14 29.53 15 3905 625 1742236
Multiple organ dysfunction syndrome 46.90 29.53 34 3886 9208 1733653
Fracture 46.83 29.53 17 3903 1061 1741800
Pyrexia 46.04 29.53 71 3849 46329 1696532
Muscular weakness 45.95 29.53 35 3885 10214 1732647
Blood pressure increased 44.46 29.53 35 3885 10718 1732143
Loss of consciousness 44.17 29.53 40 3880 14835 1728026
Hyperhidrosis 43.95 29.53 37 3883 12451 1730410
Drug reaction with eosinophilia and systemic symptoms 43.73 29.53 26 3894 5044 1737817
Pneumonia 43.50 29.53 69 3851 46113 1696748
Eye swelling 43.48 29.53 19 3901 1930 1740931
Diverticulitis 43.37 29.53 20 3900 2305 1740556
Hyponatraemia 43.16 29.53 32 3888 8968 1733893
Swelling 43.11 29.53 29 3891 6967 1735894
Alcohol use 42.95 29.53 15 3905 836 1742025
Gastrointestinal ulcer 42.91 29.53 12 3908 318 1742543
Urinary retention 42.23 29.53 26 3894 5369 1737492
Dehydration 42.00 29.53 42 3878 17616 1725245
Pseudoporphyria 41.53 29.53 9 3911 78 1742783
Palpitations 41.40 29.53 28 3892 6786 1736075
Confusional state 40.61 29.53 45 3875 21233 1721628
Diverticulum 40.49 29.53 15 3905 991 1741870
Extra dose administered 40.40 29.53 14 3906 762 1742099
Blood albumin decreased 39.83 29.53 17 3903 1631 1741230
Duodenitis 38.84 29.53 13 3907 636 1742225
Mouth ulceration 38.80 29.53 17 3903 1738 1741123
Swelling face 38.68 29.53 23 3897 4460 1738401
Rash erythematous 38.60 29.53 22 3898 3943 1738918
Iron deficiency anaemia 38.19 29.53 15 3905 1163 1741698
Weight decreased 38.14 29.53 45 3875 22708 1720153
Weight decrease neonatal 37.31 29.53 7 3913 26 1742835
Burning sensation 37.11 29.53 20 3900 3215 1739646
Oedema peripheral 36.99 29.53 37 3883 15513 1727348
Product use issue 35.64 29.53 28 3892 8543 1734318
Poisoning deliberate 35.53 29.53 13 3907 829 1742032
Purpura 35.42 29.53 16 3904 1758 1741103
C-reactive protein increased 35.31 29.53 24 3896 5861 1737000
Dyspnoea exertional 35.00 29.53 21 3899 4140 1738721
Paraesthesia 34.79 29.53 30 3890 10421 1732440
Tinnitus 34.56 29.53 19 3901 3176 1739685
Peptic ulcer perforation 34.41 29.53 7 3913 43 1742818
Hepatorenal syndrome 33.97 29.53 11 3909 485 1742376
Angina pectoris 33.82 29.53 22 3898 4996 1737865
Drug abuse 33.34 29.53 33 3887 13656 1729205
Pericardial haemorrhage 32.89 29.53 11 3909 537 1742324
Pulmonary oedema 32.88 29.53 24 3896 6562 1736299
Eosinophilia 32.81 29.53 19 3901 3508 1739353
Oedema mouth 32.64 29.53 10 3910 367 1742494
Fixed eruption 32.56 29.53 9 3911 228 1742633
Wheezing 32.46 29.53 20 3900 4133 1738728
Helicobacter test positive 32.42 29.53 8 3912 128 1742733
Moaning 32.36 29.53 8 3912 129 1742732
Eosinophilic pneumonia 32.18 29.53 11 3909 574 1742287
Failure of child resistant mechanism for pharmaceutical product 32.04 29.53 6 3914 22 1742839
Hypertension 31.81 29.53 38 3882 19410 1723451
Skin turgor decreased 31.77 29.53 7 3913 66 1742795
Off label use 31.38 29.53 54 3866 38517 1704344
Lower respiratory tract infection 31.26 29.53 19 3901 3832 1739029
Face oedema 31.23 29.53 16 3904 2320 1740541
Toxic epidermal necrolysis 31.00 29.53 16 3904 2355 1740506
Petechiae 30.71 29.53 14 3906 1571 1741290
Depressed level of consciousness 30.61 29.53 23 3897 6569 1736292
Blood loss anaemia 30.50 29.53 12 3908 934 1741927
Headache 30.45 29.53 50 3870 34326 1708535
Vision blurred 29.71 29.53 25 3895 8398 1734463

Pharmacologic Action:

SourceCodeDescription
ATC G02CC02 GENITO URINARY SYSTEM AND SEX HORMONES
OTHER GYNECOLOGICALS
OTHER GYNECOLOGICALS
Antiinflammatory products for vaginal administration
ATC M01AE02 MUSCULO-SKELETAL SYSTEM
ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS
ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS, NON-STEROIDS
Propionic acid derivatives
ATC M02AA12 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 M01AE52 MUSCULO-SKELETAL SYSTEM
ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS
ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS, NON-STEROIDS
Propionic acid derivatives
ATC M01AE56 MUSCULO-SKELETAL SYSTEM
ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS
ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS, NON-STEROIDS
Propionic acid derivatives
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
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 D006074 Gout Suppressants
MeSH PA D018373 Peripheral Nervous System Agents
MeSH PA D018689 Sensory System Agents

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Sinus headache indication 4969004
Ankylosing spondylitis indication 9631008 DOID:7147
Pain indication 22253000
Toothache indication 27355003
Tendinitis indication 34840004 DOID:971
Migraine indication 37796009 DOID:6364
Joint pain indication 57676002
Nasal discharge indication 64531003
Muscle pain indication 68962001
Rheumatoid arthritis indication 69896004 DOID:7148
Bursitis indication 84017003 DOID:2965
Gout indication 90560007 DOID:13189
Headache disorder indication 230461009
Dysmenorrhea indication 266599000
Fever indication 386661006
Osteoarthritis indication 396275006
Juvenile rheumatoid arthritis indication 410795001
Tachyarrhythmia contraindication 6285003
Alcoholism contraindication 7200002
Hypercholesterolemia contraindication 13644009
Myocardial infarction contraindication 22298006 DOID:5844
Hypovolemia contraindication 28560003
Hyperthyroidism contraindication 34486009 DOID:7998
Hypertensive disorder contraindication 38341003 DOID:10763
Gastrointestinal ulcer contraindication 40845000
Body fluid retention contraindication 43498006
Chronic heart failure contraindication 48447003
Disorder of cardiovascular system contraindication 49601007 DOID:1287
Gastrointestinal perforation contraindication 51875005
Coronary arteriosclerosis contraindication 53741008 DOID:3393
Hemiplegic migraine contraindication 59292006
Hepatic failure contraindication 59927004
Blood coagulation disorder contraindication 64779008 DOID:1247
Osteoporosis contraindication 64859006 DOID:11476
Diabetes mellitus contraindication 73211009 DOID:9351
Gastrointestinal hemorrhage contraindication 74474003
Vascular insufficiency of intestine contraindication 82196007
Atrophic gastritis contraindication 84568007 DOID:8929
Epilepsy contraindication 84757009 DOID:1826
Prinzmetal angina contraindication 87343002
Kidney disease contraindication 90708001 DOID:557
Fracture of bone contraindication 125605004
Liver function tests abnormal contraindication 166603001
Hypomagnesemia contraindication 190855004
Angina pectoris contraindication 194828000
Cerebrovascular accident contraindication 230690007
Coronary artery bypass graft contraindication 232717009
Disease of liver contraindication 235856003 DOID:409
Transient ischemic attack contraindication 266257000 DOID:224
Esophageal dysmotility contraindication 266434009 DOID:9192
Benign prostatic hyperplasia contraindication 266569009
Edema contraindication 267038008
Retention of urine contraindication 267064002
Anemia contraindication 271737000 DOID:2355
Cerebral ischemia contraindication 287731003
Pregnancy, function contraindication 289908002
Thromboembolic disorder contraindication 371039008
Serotonin syndrome contraindication 371089000
Angle-closure glaucoma contraindication 392291006 DOID:13550
Cardiovascular event risk contraindication 395112001
Peripheral vascular disease contraindication 400047006
Disorder of coronary artery contraindication 414024009
Myocardial ischemia contraindication 414795007 DOID:3393
Obesity contraindication 414916001 DOID:9970
Hypertensive urgency contraindication 443482000
Smokes tobacco daily contraindication 449868002

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 4.36 acidic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
375MG VIMOVO HORIZON N022511 April 30, 2010 RX TABLET, DELAYED RELEASE ORAL 8852636 May 31, 2022 RELIEF OF SIGNS AND SYMPTOMS OF ARTHRITIS AND RISK-REDUCTION OF NSAID-ASSOCIATED GASTRIC ULCER
375MG VIMOVO HORIZON N022511 April 30, 2010 RX TABLET, DELAYED RELEASE ORAL 8858996 May 31, 2022 RELIEF OF SIGNS AND SYMPTOMS OF ARTHRITIS AND RISK-REDUCTION OF NSAID-ASSOCIATED GASTRIC ULCER
375MG VIMOVO HORIZON N022511 April 30, 2010 RX TABLET, DELAYED RELEASE ORAL 9161920 May 31, 2022 RISK-REDUCTION OF NSAID GASTRIC ULCER IN PATIENTS REQUIRING CHRONIC NSAID TREATMENT
375MG VIMOVO HORIZON N022511 April 30, 2010 RX TABLET, DELAYED RELEASE ORAL 9198888 May 31, 2022 RISK-REDUCTION OF NSAID-ASSOCIATED GASTRIC ULCER IN PATIENTS REQUIRING NSAID TREATMENT
500MG VIMOVO HORIZON N022511 April 30, 2010 RX TABLET, DELAYED RELEASE ORAL 8852636 May 31, 2022 RELIEF OF SIGNS AND SYMPTOMS OF ARTHRITIS AND RISK-REDUCTION OF NSAID-ASSOCIATED GASTRIC ULCER
500MG VIMOVO HORIZON N022511 April 30, 2010 RX TABLET, DELAYED RELEASE ORAL 8858996 May 31, 2022 RELIEF OF SIGNS AND SYMPTOMS OF ARTHRITIS AND RISK-REDUCTION OF NSAID-ASSOCIATED GASTRIC ULCER
500MG VIMOVO HORIZON N022511 April 30, 2010 RX TABLET, DELAYED RELEASE ORAL 9161920 May 31, 2022 RISK-REDUCTION OF NSAID GASTRIC ULCER IN PATIENTS REQUIRING CHRONIC NSAID TREATMENT
500MG VIMOVO HORIZON N022511 April 30, 2010 RX TABLET, DELAYED RELEASE ORAL 9198888 May 31, 2022 RISK-REDUCTION OF NSAID-ASSOCIATED GASTRIC ULCER IN PATIENTS REQUIRING NSAID TREATMENT
375MG VIMOVO HORIZON N022511 April 30, 2010 RX TABLET, DELAYED RELEASE ORAL 6926907 Feb. 28, 2023 RELIEF OF SIGNS AND SYMPTOMS OF ARTHRITIS AND RISK-REDUCTION OF NSAID-ASSOCIATED GASTRIC ULCER
500MG VIMOVO HORIZON N022511 April 30, 2010 RX TABLET, DELAYED RELEASE ORAL 6926907 Feb. 28, 2023 RELIEF OF SIGNS AND SYMPTOMS OF ARTHRITIS AND RISK-REDUCTION OF NSAID-ASSOCIATED GASTRIC ULCER
500MG TREXIMET CURRAX N021926 April 15, 2008 RX TABLET ORAL 7332183 Oct. 2, 2025 TREATMENT OF MIGRAINE
60MG TREXIMET CURRAX N021926 May 14, 2015 DISCN TABLET ORAL 7332183 Oct. 2, 2025 ACUTE TREATMENT OF MIGRAINE
EQ 200MG BASE NAPROXEN SODIUM BIONPHARMA INC N021920 Feb. 17, 2006 OTC CAPSULE ORAL 10022344 March 3, 2026 TEMPORARY REDUCTION OF FEVER
EQ 200MG BASE NAPROXEN SODIUM BIONPHARMA INC N021920 Feb. 17, 2006 OTC CAPSULE ORAL 10022344 March 3, 2026 TEMPORARY RELIEF OF MINOR ACHES AND PAINS
EQ 200MG BASE NAPROXEN SODIUM BIONPHARMA INC N021920 Feb. 17, 2006 OTC CAPSULE ORAL 10028925 March 3, 2026 TEMPORARY REDUCTION OF FEVER
EQ 200MG BASE NAPROXEN SODIUM BIONPHARMA INC N021920 Feb. 17, 2006 OTC CAPSULE ORAL 10028925 March 3, 2026 TEMPORARY RELIEF OF MINOR ACHES AND PAINS
375MG VIMOVO HORIZON N022511 April 30, 2010 RX TABLET, DELAYED RELEASE ORAL 9393208 Sept. 3, 2029 RISK-REDUCTION OF NSAID-ASSOCIATED GASTRIC ULCER IN PATIENTS REQUIRING NSAID TREATMENT
500MG VIMOVO HORIZON N022511 April 30, 2010 RX TABLET, DELAYED RELEASE ORAL 9393208 Sept. 3, 2029 RISK-REDUCTION OF NSAID-ASSOCIATED GASTRIC ULCER IN PATIENTS REQUIRING NSAID TREATMENT
500MG VIMOVO HORIZON N022511 April 30, 2010 RX TABLET, DELAYED RELEASE ORAL 9220698 March 10, 2031 RISK-REDUCTION OF NSAID-ASSOCIATED GASTRIC ULCER IN PATIENTS REQUIRING NSAID TREATMENT
375MG VIMOVO HORIZON N022511 April 30, 2010 RX TABLET, DELAYED RELEASE ORAL 8945621 Oct. 17, 2031 RISK-REDUCTION OF NSAID-ASSOCIATED GASTRIC ULCERS IN PATIENTS ALSO TAKING LOW DOSE ASPIRIN
500MG VIMOVO HORIZON N022511 April 30, 2010 RX TABLET, DELAYED RELEASE ORAL 8945621 Oct. 17, 2031 RISK-REDUCTION OF NSAID-ASSOCIATED GASTRIC ULCERS IN PATIENTS ALSO TAKING LOW DOSE ASPIRIN

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
375MG VIMOVO HORIZON N022511 April 30, 2010 RX TABLET, DELAYED RELEASE ORAL July 6, 2020 NEW PATIENT POPULATION
500MG VIMOVO HORIZON N022511 April 30, 2010 RX TABLET, DELAYED RELEASE ORAL July 6, 2020 NEW PATIENT POPULATION

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Prostaglandin G/H synthase 2 Enzyme INHIBITOR IC50 5.60 CHEMBL CHEMBL
Prostaglandin G/H synthase 1 Enzyme INHIBITOR IC50 5.16 WOMBAT-PK CHEMBL
Aldo-keto reductase family 1 member C2 Enzyme IC50 4.50 CHEMBL
Aldo-keto reductase family 1 member C3 Enzyme IC50 6.32 CHEMBL
Hormone-sensitive lipase Enzyme IC50 5.92 CHEMBL
Prostaglandin-H2 D-isomerase Enzyme IC50 4.89 CHEMBL
Cyclooxygenase Enzyme IC50 7.22 CHEMBL
Prostaglandin G/H synthase 1 Enzyme IC50 6.74 CHEMBL
Prostaglandin G/H synthase 1 Enzyme IC50 4.96 CHEMBL

External reference:

IDSource
4018847 VUID
N0000147149 NUI
C0027396 UMLSCUI
D00118 KEGG_DRUG
57Y76R9ATQ UNII
2979 INN_ID
11847009 SNOMEDCT_US
4018847 VANDF
2111 MMSL
7258 RXNORM
372588000 SNOMEDCT_US
5155 MMSL
d00019 MMSL
002380 NDDF
26159-34-2 SECONDARY_CAS_RN
156391 PUBCHEM_CID
CHEBI:59527 CHEBI
CHEMBL154 ChEMBL_ID
DB00788 DRUGBANK_ID
CHEMBL1200806 ChEMBL_ID
NPS PDB_CHEM_ID
D009288 MESH_DESCRIPTOR_UI
5230 IUPHAR_LIGAND_ID

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Naproxen HUMAN PRESCRIPTION DRUG LABEL 1 0093-1005 TABLET, DELAYED RELEASE 375 mg ORAL ANDA 18 sections
Naproxen HUMAN PRESCRIPTION DRUG LABEL 1 0093-1006 TABLET, DELAYED RELEASE 500 mg ORAL ANDA 18 sections
Good Sense Naproxen Sodium HUMAN OTC DRUG LABEL 1 0113-0901 TABLET, FILM COATED 220 mg ORAL ANDA 9 sections
good sense naproxen sodium HUMAN OTC DRUG LABEL 1 0113-1773 TABLET, FILM COATED 220 mg ORAL ANDA 16 sections
sinus and cold d HUMAN OTC DRUG LABEL 2 0113-2417 TABLET, FILM COATED 220 mg ORAL ANDA 8 sections
Good Sense Naproxen Sodium HUMAN OTC DRUG LABEL 1 0113-4368 TABLET, FILM COATED 220 mg ORAL ANDA 9 sections
basic care naproxen sodium HUMAN OTC DRUG LABEL 1 0113-7033 TABLET, FILM COATED 220 mg ORAL ANDA 16 sections
basic care naproxen sodium pm HUMAN OTC DRUG LABEL 2 0113-7264 TABLET, FILM COATED 220 mg ORAL ANDA 10 sections
Basic Care Naproxen Sodium HUMAN OTC DRUG LABEL 1 0113-7368 TABLET, FILM COATED 220 mg ORAL ANDA 9 sections
basic care naproxen sodium HUMAN OTC DRUG LABEL 1 0113-7901 TABLET, FILM COATED 200 mg ORAL ANDA 8 sections
good sense naproxen sodium HUMAN OTC DRUG LABEL 2 0113-8264 TABLET, FILM COATED 220 mg ORAL ANDA 10 sections
Menstridol HUMAN OTC DRUG LABEL 1 0280-0270 TABLET 220 mg ORAL NDA 10 sections
Aleve PM HUMAN OTC DRUG LABEL 2 0280-1200 TABLET, FILM COATED 220 mg ORAL NDA 9 sections
Aleve HUMAN OTC DRUG LABEL 1 0280-6000 TABLET 220 mg ORAL NDA 10 sections
Aleve HUMAN OTC DRUG LABEL 1 0280-6010 TABLET 220 mg ORAL NDA 10 sections
Aleve HUMAN OTC DRUG LABEL 1 0280-6020 TABLET, COATED 220 mg ORAL NDA 10 sections
Aleve-D Sinus and Headache HUMAN OTC DRUG LABEL 2 0280-6045 TABLET 220 mg ORAL ANDA 17 sections
Aleve HUMAN OTC DRUG LABEL 1 0280-6050 TABLET 220 mg ORAL NDA 10 sections
Aleve HUMAN OTC DRUG LABEL 1 0280-6060 TABLET 220 mg ORAL NDA 10 sections
Aleve HUMAN OTC DRUG LABEL 1 0280-6070 TABLET, COATED 220 mg ORAL NDA 10 sections
Aleve HUMAN OTC DRUG LABEL 1 0280-6080 CAPSULE, LIQUID FILLED 220 mg ORAL NDA 10 sections
Aleve-D Sinus and Cold HUMAN OTC DRUG LABEL 2 0280-6090 TABLET 220 mg ORAL ANDA 17 sections
Aleve HUMAN OTC DRUG LABEL 1 0280-6091 CAPSULE, LIQUID FILLED 220 mg ORAL NDA 10 sections
Aleve Back and Muscle Pain HUMAN OTC DRUG LABEL 1 0280-6092 TABLET 220 mg ORAL NDA 17 sections
Naproxen Sodium HUMAN OTC DRUG LABEL 1 0363-0102 CAPSULE, LIQUID FILLED 220 mg ORAL NDA 17 sections
pain relief HUMAN OTC DRUG LABEL 1 0363-0140 TABLET, FILM COATED 220 mg ORAL ANDA 9 sections
All Day Pain Relief HUMAN OTC DRUG LABEL 1 0363-0168 TABLET 220 mg ORAL ANDA 9 sections
All Day Pain Relief HUMAN OTC DRUG LABEL 1 0363-0169 TABLET 220 mg ORAL ANDA 9 sections
Naproxen Sodium HUMAN OTC DRUG LABEL 1 0363-0174 CAPSULE, LIQUID FILLED 220 mg ORAL NDA 9 sections
Naproxen Sodium HUMAN OTC DRUG LABEL 1 0363-0177 CAPSULE, LIQUID FILLED 220 mg ORAL NDA 10 sections