ibuprofen Indications/Contra | FAERs | Orange Book | BioActivity |

Stem definitionDrug idCAS RN
anti-inflammatory agents, ibuprofen derivatives 1407 15687-27-1

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • ibuprofen lysine
  • ibuprofen lysinate
  • ibuprofen lysine salt
  • soluphene
  • solufenum
  • neoprofen
  • ibuprofen
  • ibuprofen sodium
A nonsteroidal anti-inflammatory agent with analgesic properties used in the therapy of rheumatism and arthritis.
  • Molecular weight: 206.29
  • Formula: C13H18O2
  • CLOGP: 3.68
  • LIPINSKI: 0
  • HAC: 2
  • HDO: 1
  • TPSA: 37.30
  • ALOGS: -3.48
  • ROTB: 4

Drug dosage:

DoseUnitRoute
30 mg P
1.20 g O
1.20 g P
1.20 g R

Approvals:

DateAgencyCompanyOrphan
Sept. 19, 1974 FDA

FDA Adverse Event Reporting System

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 3819.79 27.88 1311 16352 34369 3333827
Completed suicide 3577.44 27.88 1207 16456 29907 3338289
Acute kidney injury 3551.39 27.88 1354 16309 48329 3319867
Overdose 2687.86 27.88 1000 16663 32978 3335218
Toxicity to various agents 2640.92 27.88 1079 16584 45975 3322221
Intentional overdose 2465.03 27.88 768 16895 14457 3353739
Suicide attempt 1583.03 27.88 556 17107 15291 3352905
Gastrointestinal haemorrhage 1533.35 27.88 609 17054 23765 3344431
Angioedema 1526.84 27.88 535 17128 14600 3353596
Vomiting 1351.71 27.88 845 16818 88686 3279510
Haematemesis 1305.16 27.88 393 17270 6492 3361704
Urticaria 974.77 27.88 465 17198 28262 3339934
Melaena 938.04 27.88 310 17353 7002 3361194
Gastric ulcer 931.53 27.88 279 17384 4506 3363690
Metabolic acidosis 905.57 27.88 316 17347 8462 3359734
Tubulointerstitial nephritis 867.85 27.88 259 17404 4127 3364069
Drug interaction 795.05 27.88 478 17185 46334 3321862
Hypotension 772.82 27.88 479 17184 49035 3319161
Gastritis 713.71 27.88 246 17417 6331 3361865
Nausea 684.48 27.88 657 17006 128988 3239208
Upper gastrointestinal haemorrhage 630.75 27.88 199 17464 3844 3364352
Aspirin-exacerbated respiratory disease 608.83 27.88 111 17552 108 3368088
Toxic epidermal necrolysis 607.85 27.88 199 17464 4346 3363850
Anaphylactic reaction 582.26 27.88 256 17407 12798 3355398
Gastric haemorrhage 571.92 27.88 177 17486 3199 3364997
Coma 565.79 27.88 248 17415 12304 3355892
Somnolence 556.56 27.88 333 17330 31871 3336325
Renal failure 554.77 27.88 335 17328 32605 3335591
Abdominal pain upper 546.46 27.88 301 17362 24615 3343581
Hypothermia 542.25 27.88 168 17495 3047 3365149
Stevens-Johnson syndrome 533.85 27.88 200 17463 6572 3361624
Renal tubular necrosis 530.89 27.88 164 17499 2944 3365252
Cardiac arrest 528.60 27.88 304 17359 27015 3341181
Duodenal ulcer 523.34 27.88 154 17509 2324 3365872
Tachycardia 522.57 27.88 286 17377 23085 3345111
Abdominal pain 515.57 27.88 363 17300 45862 3322334
Poisoning 488.43 27.88 174 17489 4938 3363258
Off label use 473.93 27.88 367 17296 53610 3314586
Bronchopulmonary dysplasia 469.50 27.88 93 17570 191 3368005
Intentional product misuse 458.48 27.88 215 17448 12486 3355710
Dyspnoea 446.57 27.88 470 17193 102464 3265732
Anaemia 445.82 27.88 355 17308 53978 3314218
Respiratory arrest 443.20 27.88 203 17460 11165 3357031
Condition aggravated 441.63 27.88 310 17353 38923 3329273
Pyrexia 427.93 27.88 412 17251 80703 3287493
Dizziness 425.20 27.88 400 17263 76112 3292084
Hypersensitivity 424.22 27.88 266 17397 27634 3340562
Drug ineffective 421.97 27.88 483 17180 115607 3252589
Drug abuse 408.65 27.88 224 17439 18106 3350090
Pruritus 392.56 27.88 310 17353 46523 3321673
Faeces discoloured 382.40 27.88 136 17527 3836 3364360
Blood creatinine increased 374.90 27.88 225 17438 21593 3346603
Cardio-respiratory arrest 367.23 27.88 197 17466 15243 3352953
Asthma 363.23 27.88 182 17481 12220 3355976
Rash 354.96 27.88 350 17313 70471 3297725
Meningitis aseptic 351.84 27.88 91 17572 820 3367376
Haemoglobin decreased 351.46 27.88 244 17419 30050 3338146
Abdominal discomfort 351.23 27.88 205 17458 18679 3349517
Gastritis erosive 344.39 27.88 101 17562 1503 3366693
Product use issue 341.35 27.88 190 17473 15811 3352385
Lip swelling 316.24 27.88 134 17529 6097 3362099
Acute hepatic failure 307.49 27.88 117 17546 4006 3364190
Duodenal ulcer haemorrhage 305.40 27.88 83 17580 920 3367276
Erosive oesophagitis 301.38 27.88 73 17590 488 3367708
Necrotising colitis 298.84 27.88 70 17593 397 3367799
Hyperkalaemia 287.95 27.88 151 17512 11143 3357053
Swelling face 277.93 27.88 148 17515 11268 3356928
Nasal disorder 262.13 27.88 62 17601 369 3367827
Duodenal ulcer perforation 261.19 27.88 65 17598 493 3367703
Duodenitis 260.23 27.88 74 17589 980 3367216
Dehydration 258.77 27.88 212 17451 33437 3334759
Headache 252.80 27.88 333 17330 91647 3276549
Rectal haemorrhage 252.53 27.88 130 17533 9228 3358968
Gastric ulcer haemorrhage 251.46 27.88 79 17584 1499 3366697
Alanine aminotransferase increased 247.60 27.88 179 17484 23461 3344735
Asthenia 247.45 27.88 279 17384 65386 3302810
Renal papillary necrosis 243.23 27.88 45 17618 51 3368145
Drug-induced liver injury 243.05 27.88 105 17558 5008 3363188
Death 236.69 27.88 423 17240 151901 3216295
Pain 231.25 27.88 281 17382 71276 3296920
Diarrhoea 225.99 27.88 337 17326 104011 3264185
Kounis syndrome 223.95 27.88 56 17607 434 3367762
Weight decreased 222.66 27.88 210 17453 39901 3328295
Loss of consciousness 221.94 27.88 180 17483 27967 3340229
Agitation 219.62 27.88 155 17508 19551 3348645
Vanishing bile duct syndrome 210.79 27.88 48 17615 235 3367961
Gastrointestinal disorder 207.68 27.88 119 17544 10450 3357746
Iron deficiency anaemia 206.21 27.88 77 17586 2498 3365698
Renal impairment 202.01 27.88 143 17520 18118 3350078
International normalised ratio increased 198.64 27.88 130 17533 14485 3353711
Haematuria 198.07 27.88 113 17550 9839 3358357
Lip oedema 195.26 27.88 59 17604 977 3367219
Acute generalised exanthematous pustulosis 194.90 27.88 70 17593 2029 3366167
Intentional self-injury 193.79 27.88 90 17573 5095 3363101
Malaise 192.90 27.88 245 17418 64932 3303264
Hypertension 191.99 27.88 190 17473 38276 3329920
Anuria 190.49 27.88 75 17588 2816 3365380
Medication error 189.75 27.88 117 17546 11754 3356442
Renal tubular acidosis 188.97 27.88 51 17612 549 3367647
Confusional state 188.37 27.88 187 17476 37811 3330385
Hepatic failure 188.32 27.88 112 17551 10540 3357656
Acute respiratory distress syndrome 182.80 27.88 90 17573 5804 3362392
Haematochezia 182.42 27.88 96 17567 7125 3361071
Hypokalaemia 178.39 27.88 119 17544 13686 3354510
Hepatitis cholestatic 178.38 27.88 64 17599 1849 3366347
Decreased appetite 178.16 27.88 189 17474 41301 3326895
Haemorrhage 177.59 27.88 137 17526 19784 3348412
Drug reaction with eosinophilia and systemic symptoms 177.14 27.88 97 17566 7798 3360398
Blood urea increased 175.49 27.88 95 17568 7465 3360731
Dyspepsia 174.28 27.88 111 17552 11801 3356395
Acidosis 173.99 27.88 69 17594 2641 3365555
Hyperhidrosis 173.53 27.88 145 17518 23465 3344731
Depressed level of consciousness 170.63 27.88 108 17555 11357 3356839
Agranulocytosis 170.38 27.88 83 17580 5229 3362967
Erythema 169.72 27.88 156 17507 28654 3339542
Lethargy 169.60 27.88 116 17547 13899 3354297
Pharyngitis 169.22 27.88 67 17596 2553 3365643
Wheezing 165.87 27.88 94 17569 8077 3360119
Eye disorder 163.93 27.88 73 17590 3744 3364452
Syncope 163.17 27.88 145 17518 25488 3342708
Peptic ulcer 161.89 27.88 51 17612 976 3367220
Respiratory failure 161.59 27.88 138 17525 23003 3345193
Face oedema 160.28 27.88 79 17584 5105 3363091
Rhabdomyolysis 159.80 27.88 117 17546 15612 3352584
Erythema multiforme 158.50 27.88 68 17595 3185 3365011
Drug eruption 158.16 27.88 78 17585 5047 3363149
Oesophageal ulcer 156.55 27.88 52 17611 1185 3367011
Heart rate increased 154.55 27.88 111 17552 14375 3353821
Seizure 154.19 27.88 173 17490 40227 3327969
Exposure during pregnancy 154.14 27.88 145 17518 27418 3340778
Milk-alkali syndrome 151.75 27.88 33 17630 125 3368071
Coma scale abnormal 151.54 27.88 50 17613 1115 3367081
Gastric ulcer perforation 149.05 27.88 38 17625 321 3367875
Accidental overdose 147.49 27.88 83 17580 7035 3361161
Coagulopathy 147.40 27.88 73 17590 4766 3363430
Aspartate aminotransferase increased 145.55 27.88 125 17538 20988 3347208
Rash maculo-papular 145.35 27.88 77 17586 5790 3362406
Jaundice 144.90 27.88 93 17570 10014 3358182
Hepatitis 144.04 27.88 91 17572 9534 3358662
Eyelid oedema 142.28 27.88 64 17599 3361 3364835
Lactic acidosis 140.79 27.88 82 17581 7418 3360778
Cholestasis 140.63 27.88 73 17590 5264 3362932
Eye swelling 137.74 27.88 71 17592 5046 3363150
Mental status changes 134.76 27.88 89 17574 10058 3358138
Ulcer 134.27 27.88 55 17608 2291 3365905
Self-medication 133.75 27.88 46 17617 1169 3367027
Drug ineffective for unapproved indication 132.88 27.88 61 17602 3359 3364837
Extra dose administered 132.50 27.88 47 17616 1312 3366884
Nephropathy toxic 132.39 27.88 59 17604 3030 3365166
Periorbital oedema 132.25 27.88 48 17615 1434 3366762
Brain oedema 129.73 27.88 62 17601 3742 3364454
Polyuria 129.12 27.88 51 17612 1930 3366266
Apnoea 127.51 27.88 54 17609 2448 3365748
Leukocytosis 126.24 27.88 70 17593 5763 3362433
Sepsis 125.82 27.88 140 17523 32233 3335963
Product quality issue 124.00 27.88 127 17536 26608 3341588
Bezoar 123.98 27.88 31 17632 240 3367956
Haemodialysis 122.84 27.88 63 17600 4429 3363767
Pancreatitis acute 122.37 27.88 72 17591 6636 3361560
Intestinal perforation 121.11 27.88 55 17608 2953 3365243
Oesophagitis 119.14 27.88 56 17607 3255 3364941
Incorrect dose administered 118.12 27.88 93 17570 13821 3354375
Tachypnoea 115.33 27.88 56 17607 3500 3364696
Sopor 115.28 27.88 57 17606 3707 3364489
Conjunctivitis 114.96 27.88 52 17611 2766 3365430
Blood pressure decreased 114.28 27.88 91 17572 13745 3354451
Anaphylactic shock 113.71 27.88 65 17598 5674 3362522
Transaminases increased 113.45 27.88 69 17594 6755 3361441
Ataxia 113.13 27.88 58 17605 4074 3364122
Thrombocytopenia 112.81 27.88 138 17525 35130 3333066
Hypophagia 110.41 27.88 65 17598 5996 3362200
Gastrooesophageal reflux disease 109.84 27.88 83 17580 11608 3356588
Bradycardia 109.42 27.88 96 17567 16573 3351623
Chest pain 108.96 27.88 145 17518 40130 3328066
Ear infection 108.95 27.88 53 17610 3326 3364870
Electrocardiogram QT prolonged 108.93 27.88 80 17583 10715 3357481
Sinus tachycardia 106.74 27.88 59 17604 4826 3363370
Swelling 106.05 27.88 100 17563 18944 3349252
Contraindicated product administered 104.33 27.88 36 17627 924 3367272
Cough 102.48 27.88 140 17523 39718 3328478
Multiple organ dysfunction syndrome 100.67 27.88 86 17577 14324 3353872
Proteinuria 100.53 27.88 56 17607 4650 3363546
Liver function test abnormal 100.49 27.88 82 17581 12819 3355377
Intestinal diaphragm disease 100.07 27.88 21 17642 64 3368132
Haematocrit decreased 99.56 27.88 66 17597 7501 3360695
White blood cell count increased 99.17 27.88 81 17582 12679 3355517
Fatigue 98.94 27.88 241 17422 106999 3261197
Gastritis haemorrhagic 98.55 27.88 29 17634 436 3367760
Back pain 98.48 27.88 134 17529 37871 3330325
Lower gastrointestinal haemorrhage 96.50 27.88 40 17623 1717 3366479
Fixed eruption 96.07 27.88 24 17639 185 3368011
Dysphagia 95.93 27.88 96 17567 19555 3348641
Gastrointestinal pain 95.48 27.88 36 17627 1199 3366997
Gastrointestinal ulcer 95.22 27.88 30 17633 574 3367622
Hepatitis acute 93.70 27.88 42 17621 2186 3366010
Prothrombin time prolonged 92.84 27.88 46 17617 3004 3365192
Liver injury 91.74 27.88 48 17615 3516 3364680
Unresponsive to stimuli 91.47 27.88 64 17599 7944 3360252
Ureteric obstruction 90.90 27.88 27 17636 420 3367776
Eosinophilia 90.70 27.88 53 17610 4820 3363376
Poisoning deliberate 90.52 27.88 33 17630 998 3367198
Circulatory collapse 90.00 27.88 57 17606 5992 3362204
Hepatic necrosis 90.00 27.88 38 17625 1709 3366487
Pneumonia 89.97 27.88 180 17483 69963 3298233
Erosive duodenitis 89.46 27.88 25 17638 309 3367887
Acute myocardial infarction 89.44 27.88 75 17588 12176 3356020
Haemoptysis 89.26 27.88 59 17604 6672 3361524
Pulmonary oedema 89.19 27.88 74 17589 11837 3356359
Pruritus generalised 89.07 27.88 56 17607 5813 3362383
Insomnia 87.63 27.88 123 17540 35775 3332421
Rash erythematous 87.15 27.88 62 17601 7900 3360296
Oesophageal stenosis 86.79 27.88 29 17634 673 3367523
Oliguria 85.57 27.88 39 17624 2111 3366085
Pulseless electrical activity 85.41 27.88 36 17627 1612 3366584
Hypoxia 84.88 27.88 66 17597 9625 3358571
Blister 84.24 27.88 63 17600 8671 3359525
Post procedural haemorrhage 83.34 27.88 41 17622 2636 3365560
Shock 82.88 27.88 57 17606 6880 3361316
Mydriasis 82.68 27.88 42 17621 2892 3365304
Large intestinal ulcer 82.60 27.88 28 17635 680 3367516
Gastrointestinal sounds abnormal 82.44 27.88 29 17634 789 3367407
Deafness transitory 82.37 27.88 20 17643 135 3368061
Blood bilirubin increased 82.27 27.88 67 17596 10442 3357754
Generalised tonic-clonic seizure 82.03 27.88 60 17603 7982 3360214
Pallor 81.73 27.88 53 17610 5802 3362394
Drug intolerance 81.56 27.88 70 17593 11728 3356468
Oedema peripheral 81.30 27.88 116 17547 34245 3333951
Inflammation 81.27 27.88 58 17605 7427 3360769
Bronchospasm 80.70 27.88 47 17616 4247 3363949
Rash generalised 80.04 27.88 64 17599 9718 3358478
Oedema 79.64 27.88 76 17587 14604 3353592
Musculoskeletal stiffness 79.08 27.88 74 17589 13876 3354320
Arrhythmia 78.69 27.88 65 17598 10332 3357864
Flank pain 78.03 27.88 36 17627 2004 3366192
Alcohol use 77.96 27.88 32 17631 1339 3366857
Deafness 77.85 27.88 45 17618 4009 3364187
Blood alkaline phosphatase increased 77.84 27.88 65 17598 10488 3357708
Rhinitis 77.43 27.88 32 17631 1363 3366833
Dermatitis exfoliative 76.53 27.88 39 17624 2704 3365492
Chest discomfort 76.30 27.88 80 17583 17205 3350991
Drug use disorder 75.49 27.88 28 17635 890 3367306
Chromaturia 75.16 27.88 46 17617 4552 3363644
Intraventricular haemorrhage 75.07 27.88 27 17636 785 3367411
Shoulder arthroplasty 74.87 27.88 22 17641 329 3367867
Hepatic enzyme increased 74.79 27.88 71 17592 13554 3354642
General physical health deterioration 74.76 27.88 86 17577 20503 3347693
Hepatotoxicity 74.60 27.88 49 17614 5482 3362714
Hyponatraemia 74.04 27.88 81 17582 18278 3349918
Petechiae 73.55 27.88 39 17624 2935 3365261
Hiatus hernia 73.55 27.88 39 17624 2935 3365261
Hypercalcaemia 73.15 27.88 42 17621 3695 3364501
Drug level increased 73.09 27.88 45 17618 4500 3363696
Brain death 72.80 27.88 27 17636 858 3367338
Chronic kidney disease 72.80 27.88 51 17612 6341 3361855
Thrombotic thrombocytopenic purpura 72.33 27.88 31 17632 1447 3366749
Aggression 71.57 27.88 64 17599 11321 3356875
Blood pressure increased 71.05 27.88 87 17576 22143 3346053
Respiratory distress 71.02 27.88 56 17607 8332 3359864
Neutrophilia 70.90 27.88 25 17638 685 3367511
Haemolytic anaemia 70.77 27.88 39 17624 3170 3365026
Therapeutic product cross-reactivity 70.71 27.88 20 17643 259 3367937
Arthralgia 70.71 27.88 150 17513 60711 3307485
Rash macular 70.29 27.88 43 17620 4251 3363945
Poor quality drug administered 70.00 27.88 28 17635 1095 3367101
Swollen tongue 69.67 27.88 51 17612 6792 3361404
Lymphadenopathy 69.42 27.88 54 17609 7878 3360318
Chills 68.47 27.88 85 17578 21937 3346259
Miosis 67.94 27.88 33 17630 2063 3366133
Drug effect incomplete 67.74 27.88 53 17610 7797 3360399
Brain injury 67.36 27.88 30 17633 1537 3366659
Haemorrhagic anaemia 67.17 27.88 31 17632 1727 3366469
Tinnitus 66.94 27.88 51 17612 7214 3360982
Haemodynamic instability 66.91 27.88 32 17631 1933 3366263
Respiratory depression 66.90 27.88 40 17623 3794 3364402
Gastric disorder 66.86 27.88 40 17623 3798 3364398
Hypertensive crisis 65.99 27.88 37 17626 3110 3365086
Feeling hot 65.67 27.88 52 17611 7784 3360412
Constipation 65.61 27.88 99 17564 30713 3337483
Blood lactic acid increased 65.37 27.88 28 17635 1305 3366891
Respiratory disorder 64.07 27.88 46 17617 5944 3362252
Cardiogenic shock 64.01 27.88 39 17624 3827 3364369
Pain in extremity 63.88 27.88 127 17536 49085 3319111
Protein-losing gastroenteropathy 63.74 27.88 16 17647 126 3368070
Shock haemorrhagic 63.56 27.88 31 17632 1955 3366241
Foetal exposure during pregnancy 63.38 27.88 69 17594 15482 3352714
Laryngeal oedema 62.79 27.88 30 17633 1808 3366388
Myalgia 62.61 27.88 99 17564 31976 3336220
Occult blood positive 62.59 27.88 25 17638 974 3367222
Labelled drug-drug interaction medication error 62.24 27.88 27 17636 1298 3366898
Necrotising fasciitis 62.14 27.88 24 17639 854 3367342
Hypoaldosteronism 61.90 27.88 14 17649 66 3368130
Hepatocellular injury 61.87 27.88 40 17623 4355 3363841
Gastrointestinal necrosis 61.57 27.88 25 17638 1017 3367179
Alcohol poisoning 61.51 27.88 23 17640 748 3367448
Macrophages increased 61.45 27.88 12 17651 22 3368174
Tonsillitis 60.93 27.88 25 17638 1045 3367151
Blood bicarbonate decreased 60.77 27.88 23 17640 774 3367422
Dysarthria 60.24 27.88 54 17609 9580 3358616
Conjunctival hyperaemia 59.82 27.88 24 17639 946 3367250
Pleural effusion 59.20 27.88 73 17590 18706 3349490
Pulmonary congestion 58.95 27.88 34 17629 3016 3365180
Mouth ulceration 58.90 27.88 39 17624 4421 3363775
Blood pH decreased 58.75 27.88 23 17640 849 3367347
Hepatic encephalopathy 58.32 27.88 35 17628 3342 3364854
Suicidal ideation 57.72 27.88 70 17593 17635 3350561
Muscular weakness 57.67 27.88 75 17588 20266 3347930
Blood ethanol increased 56.97 27.88 14 17649 100 3368096
Hepatic function abnormal 56.90 27.88 56 17607 11171 3357025
Pulmonary hypertension 56.27 27.88 44 17619 6466 3361730
Ulcer haemorrhage 56.10 27.88 22 17641 816 3367380
Mallory-Weiss syndrome 55.79 27.88 19 17644 468 3367728
Hepatic steatosis 55.43 27.88 39 17624 4881 3363315
Glomerulonephritis membranous 54.97 27.88 17 17646 305 3367891
Obstruction gastric 54.31 27.88 17 17646 318 3367878
Pulmonary haemorrhage 53.95 27.88 31 17632 2730 3365466
Disseminated intravascular coagulation 53.69 27.88 42 17621 6175 3362021
C-reactive protein increased 53.60 27.88 50 17613 9333 3358863
Disturbance in attention 53.59 27.88 47 17616 8101 3360095
Blood glucose increased 53.33 27.88 70 17593 19085 3349111
Jejunal ulcer 53.16 27.88 12 17651 56 3368140
Varicella 53.15 27.88 20 17643 662 3367534
Glomerular filtration rate decreased 52.56 27.88 29 17634 2362 3365834
Neutrophil Pelger-Huet anomaly present 52.52 27.88 13 17650 96 3368100
Anxiety 52.29 27.88 103 17560 39526 3328670
Accidental exposure to product 51.71 27.88 37 17626 4755 3363441
Septic shock 51.29 27.88 55 17608 12129 3356067
Oropharyngeal pain 51.10 27.88 55 17608 12179 3356017
Atrial fibrillation 51.06 27.88 77 17586 23864 3344332
Presyncope 51.03 27.88 38 17625 5193 3363003
Hypernatraemia 50.96 27.88 25 17638 1597 3366599
Renal disorder 50.93 27.88 43 17620 7041 3361155
Skin exfoliation 50.15 27.88 45 17618 7992 3360204
Drug screen positive 49.71 27.88 26 17637 1902 3366294
Gastrointestinal perforation 49.70 27.88 24 17639 1481 3366715
Feeling abnormal 49.68 27.88 82 17581 27443 3340753
Hypovolaemia 49.51 27.88 27 17636 2149 3366047
Blood sodium decreased 49.40 27.88 36 17627 4760 3363436
Paraesthesia oral 49.21 27.88 28 17635 2420 3365776
Duodenal obstruction 49.04 27.88 12 17651 84 3368112
Ductus arteriosus premature closure 48.92 27.88 12 17651 85 3368111
Dialysis 48.90 27.88 34 17629 4175 3364021
Helicobacter infection 48.81 27.88 20 17643 833 3367363
Reaction to excipient 48.80 27.88 17 17646 449 3367747
Mycoplasma infection 48.75 27.88 13 17650 133 3368063
Haematoma 48.60 27.88 43 17620 7496 3360700
Pneumonia pneumococcal 48.55 27.88 17 17646 456 3367740
Urine output decreased 48.24 27.88 28 17635 2513 3365683
Abdominal distension 48.08 27.88 56 17607 13520 3354676
Febrile convulsion 48.00 27.88 15 17648 279 3367917
Blood creatine increased 47.94 27.88 22 17641 1209 3366987
Obstructive airways disorder 47.61 27.88 24 17639 1625 3366571
Drug administration error 46.99 27.88 39 17624 6237 3361959
Lower respiratory tract infection 46.96 27.88 40 17623 6629 3361567
Generalised erythema 46.92 27.88 26 17637 2135 3366061
Drug abuser 46.64 27.88 28 17635 2675 3365521
Infection 46.28 27.88 76 17587 25326 3342870
Neutrophil count increased 46.03 27.88 32 17631 3928 3364268
Dermatomyositis 45.87 27.88 17 17646 539 3367657
Microcytic anaemia 45.66 27.88 18 17645 677 3367519
Paraesthesia 45.64 27.88 79 17584 27469 3340727
Body temperature decreased 44.96 27.88 24 17639 1830 3366366
Kidney enlargement 44.77 27.88 14 17649 261 3367935
Pharyngeal oedema 44.67 27.88 33 17630 4454 3363742
Gastric perforation 44.66 27.88 17 17646 581 3367615
Throat tightness 44.46 27.88 34 17629 4834 3363362
Maternal exposure during pregnancy 44.35 27.88 47 17616 10224 3357972
Ductus arteriosus stenosis foetal 44.05 27.88 12 17651 134 3368062
Pancytopenia 43.69 27.88 63 17600 18757 3349439
Osteoarthritis 43.60 27.88 41 17622 7729 3360467
Hyperventilation 43.47 27.88 22 17641 1502 3366694
Enthesopathy 43.45 27.88 11 17652 90 3368106
Disorientation 43.30 27.88 46 17617 10033 3358163
Liver disorder 42.76 27.88 46 17617 10177 3358019
Palatal oedema 42.22 27.88 14 17649 317 3367879
Alveolitis 42.18 27.88 17 17646 678 3367518
Epistaxis 42.08 27.88 54 17609 14397 3353799
Rhinorrhoea 42.05 27.88 40 17623 7649 3360547
Contusion 42.00 27.88 55 17608 14955 3353241
Purpura 41.98 27.88 27 17636 2913 3365283
Streptococcal infection 41.95 27.88 20 17643 1199 3366997
Foot operation 41.92 27.88 17 17646 689 3367507
Helicobacter test positive 41.89 27.88 13 17650 236 3367960
Blood lactate dehydrogenase increased 41.85 27.88 37 17626 6443 3361753
Palpitations 41.58 27.88 62 17601 19021 3349175
Peptic ulcer perforation 41.51 27.88 10 17653 65 3368131
Dermatitis bullous 41.47 27.88 24 17639 2142 3366054
Toxic skin eruption 41.25 27.88 27 17636 3001 3365195
Implant site extravasation 41.14 27.88 14 17649 344 3367852
Drug dependence 40.93 27.88 31 17632 4345 3363851
Small intestinal haemorrhage 40.81 27.88 16 17647 593 3367603
Nasal polyps 40.76 27.88 13 17650 259 3367937
Fall 40.63 27.88 119 17544 58764 3309432
Tremor 40.61 27.88 76 17587 28068 3340128
Ecchymosis 40.45 27.88 24 17639 2244 3365952
Evans syndrome 40.37 27.88 11 17652 123 3368073
Product taste abnormal 40.35 27.88 17 17646 760 3367436
Retinopathy of prematurity 40.26 27.88 12 17651 189 3368007
Loss of personal independence in daily activities 39.97 27.88 33 17630 5237 3362959
Nephritis 39.89 27.88 16 17647 630 3367566
Cellulitis 39.81 27.88 49 17614 12526 3355670
Intestinal ischaemia 39.72 27.88 22 17641 1805 3366391
Colitis microscopic 39.69 27.88 17 17646 792 3367404
Discomfort 39.60 27.88 36 17627 6500 3361696
Depression 39.36 27.88 92 17571 39678 3328518
Substance abuse 39.33 27.88 19 17644 1173 3367023
Cardiac failure 39.13 27.88 62 17601 20043 3348153
Brain empyema 38.80 27.88 7 17656 6 3368190
Blood creatine phosphokinase increased 38.47 27.88 49 17614 12964 3355232
Therapeutic response unexpected 38.45 27.88 32 17631 5136 3363060
Exposure via ingestion 38.11 27.88 20 17643 1473 3366723
Gamma-glutamyltransferase increased 38.05 27.88 41 17622 9087 3359109
Duodenal stenosis 37.97 27.88 11 17652 156 3368040
Haemorrhage intracranial 37.54 27.88 32 17631 5307 3362889
Peritonitis 37.53 27.88 31 17632 4924 3363272
Tongue oedema 37.34 27.88 18 17645 1106 3367090
Myocardial infarction 37.21 27.88 96 17567 44037 3324159
Scar 37.18 27.88 24 17639 2605 3365591
Electrocardiogram QRS complex prolonged 37.14 27.88 19 17644 1327 3366869
Pneumonia aspiration 37.11 27.88 36 17627 7052 3361144
Metabolic alkalosis 36.93 27.88 14 17649 473 3367723
Duodenal ulcer repair 36.92 27.88 7 17656 10 3368186
Glomerulonephritis minimal lesion 36.68 27.88 10 17653 112 3368084
Blood potassium decreased 36.67 27.88 34 17629 6296 3361900
Premature baby 36.41 27.88 36 17627 7217 3360979
Nephrotic syndrome 36.40 27.88 22 17641 2127 3366069
Respiratory rate increased 36.37 27.88 23 17640 2410 3365786
Accidental exposure to product by child 36.30 27.88 19 17644 1392 3366804
Abdominal tenderness 36.28 27.88 19 17644 1393 3366803
Product use in unapproved indication 36.19 27.88 27 17636 3699 3364497
Angular cheilitis 36.18 27.88 9 17654 68 3368128
Staphylococcal scalded skin syndrome 36.07 27.88 9 17654 69 3368127
Drug withdrawal syndrome 35.83 27.88 45 17618 11740 3356456
Sedation 35.79 27.88 33 17630 6068 3362128
Purulent discharge 35.61 27.88 18 17645 1226 3366970
Tongue disorder 35.52 27.88 19 17644 1455 3366741
Burning sensation 35.38 27.88 39 17624 8865 3359331
Foetal death 35.18 27.88 21 17642 1985 3366211
Colitis 35.11 27.88 35 17628 7086 3361110
Vision blurred 34.85 27.88 58 17605 19531 3348665
Epigastric discomfort 34.77 27.88 15 17648 711 3367485
Feeding disorder 34.67 27.88 19 17644 1527 3366669
Anion gap increased 34.61 27.88 13 17650 428 3367768
Necrotising enterocolitis neonatal 34.49 27.88 9 17654 84 3368112
Viral infection 34.49 27.88 32 17631 5930 3362266
Blood potassium increased 34.27 27.88 27 17636 4009 3364187
Pupillary reflex impaired 34.27 27.88 15 17648 737 3367459
Renal cortical necrosis 34.19 27.88 8 17655 45 3368151
Sinus bradycardia 33.97 27.88 25 17638 3354 3364842
Extradural haematoma 33.94 27.88 13 17650 452 3367744
Hypoalbuminaemia 33.63 27.88 22 17641 2442 3365754
Duodenitis haemorrhagic 33.62 27.88 8 17655 49 3368147
Blood urine present 33.52 27.88 24 17639 3086 3365110
Colitis ischaemic 33.50 27.88 21 17642 2167 3366029
Fluid intake reduced 33.44 27.88 16 17647 967 3367229
Coma hepatic 33.32 27.88 12 17651 350 3367846
Cutaneous symptom 33.08 27.88 8 17655 53 3368143
Diverticulum 32.87 27.88 22 17641 2538 3365658
Duodenal perforation 32.80 27.88 11 17652 258 3367938
Electrocardiogram abnormal 32.73 27.88 21 17642 2256 3365940
Pyroglutamate increased 32.69 27.88 8 17655 56 3368140
Brain herniation 32.61 27.88 16 17647 1022 3367174
Scratch 32.49 27.88 16 17647 1030 3367166
Aspiration 32.49 27.88 23 17640 2905 3365291
Mental disorder 32.46 27.88 31 17632 5956 3362240
Therapy non-responder 32.43 27.88 41 17622 10768 3357428
Implant site infection 32.39 27.88 14 17649 667 3367529
Pharyngeal abscess 32.15 27.88 9 17654 112 3368084
Ascites 32.07 27.88 38 17625 9339 3358857
Vasculitis 31.98 27.88 24 17639 3317 3364879
Blood pressure diastolic decreased 31.92 27.88 18 17645 1529 3366667
Body temperature increased 31.85 27.88 28 17635 4838 3363358
Normochromic normocytic anaemia 31.71 27.88 17 17646 1307 3366889
Hepatomegaly 31.61 27.88 23 17640 3032 3365164
Heat stroke 31.49 27.88 11 17652 293 3367903
Kawasaki's disease 31.43 27.88 8 17655 67 3368129
Anal incontinence 31.40 27.88 21 17642 2419 3365777
Pneumothorax 31.32 27.88 26 17637 4158 3364038
Toxic shock syndrome streptococcal 31.31 27.88 7 17656 31 3368165
Cold sweat 31.29 27.88 23 17640 3080 3365116
Ventricular tachycardia 31.12 27.88 30 17633 5832 3362364
Platelet count decreased 31.04 27.88 67 17596 27401 3340795
Electrolyte imbalance 30.98 27.88 22 17641 2792 3365404
Diverticulum intestinal haemorrhagic 30.94 27.88 12 17651 432 3367764
Dyspnoea exertional 30.60 27.88 32 17631 6854 3361342
Necrotising retinitis 30.42 27.88 9 17654 138 3368058
Skin hyperpigmentation 30.24 27.88 16 17647 1198 3366998
Crying 30.15 27.88 28 17635 5195 3363001
Beta haemolytic streptococcal infection 30.13 27.88 11 17652 334 3367862
Pneumococcal infection 30.00 27.88 9 17654 145 3368051
Oligohydramnios 29.99 27.88 15 17648 999 3367197
Anti-transglutaminase antibody 29.89 27.88 5 17658 1 3368195
Anoxia 29.83 27.88 9 17654 148 3368048
Throat irritation 29.83 27.88 28 17635 5266 3362930
Ileal perforation 29.80 27.88 10 17653 235 3367961
Epiglottic oedema 29.64 27.88 8 17655 86 3368110
Superinfection 29.48 27.88 12 17651 491 3367705
PO2 increased 29.41 27.88 10 17653 245 3367951
Urinary tract infection 29.39 27.88 71 17592 31257 3336939
Lip exfoliation 29.28 27.88 9 17654 158 3368038
Skin lesion 29.21 27.88 28 17635 5405 3362791
Diarrhoea haemorrhagic 29.11 27.88 18 17645 1813 3366383
Drug prescribing error 29.07 27.88 25 17638 4195 3364001
Vaginal ulceration 29.00 27.88 8 17655 94 3368102
Synovitis 28.98 27.88 18 17645 1827 3366369
Encephalitis 28.96 27.88 18 17645 1829 3366367
Cerebral haemorrhage 28.96 27.88 37 17626 9817 3358379
Eating disorder 28.93 27.88 21 17642 2758 3365438
Night sweats 28.68 27.88 26 17637 4677 3363519
Blood calcium decreased 28.66 27.88 21 17642 2799 3365397
Multi-organ disorder 28.64 27.88 12 17651 529 3367667
Neonatal disorder 28.59 27.88 13 17650 699 3367497
Migraine 28.48 27.88 37 17626 9979 3358217
Encephalopathy 28.47 27.88 32 17631 7430 3360766
Joint swelling 28.35 27.88 49 17614 17008 3351188
Onychomycosis 28.33 27.88 13 17650 714 3367482
Duodenogastric reflux 28.18 27.88 6 17657 20 3368176
Anion gap 28.01 27.88 7 17656 54 3368142

Pharmacologic Action:

SourceCodeDescription
ATC C01EB16 CARDIOVASCULAR SYSTEM
CARDIAC THERAPY
OTHER CARDIAC PREPARATIONS
Other cardiac preparations
ATC G02CC01 GENITO URINARY SYSTEM AND SEX HORMONES
OTHER GYNECOLOGICALS
OTHER GYNECOLOGICALS
Antiinflammatory products for vaginal administration
ATC M01AE01 MUSCULO-SKELETAL SYSTEM
ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS
ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS, NON-STEROIDS
Propionic acid derivatives
ATC M02AA13 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 R02AX02 RESPIRATORY SYSTEM
THROAT PREPARATIONS
THROAT PREPARATIONS
Other throat preparations
ATC M01AE51 MUSCULO-SKELETAL SYSTEM
ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS
ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS, NON-STEROIDS
Propionic acid derivatives
ATC N02AJ08 NERVOUS SYSTEM
ANALGESICS
OPIOIDS
Opioids in combination with non-opioid analgesics
ATC N02AJ19 NERVOUS SYSTEM
ANALGESICS
OPIOIDS
Opioids in combination with non-opioid analgesics
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 D002491 Central Nervous System 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
Sinus headache indication 4969004
Pain indication 22253000
Rheumatoid arthritis indication 69896004 DOID:7148
Severe pain indication 76948002
Patent ductus arteriosus indication 83330001 DOID:13832
Headache disorder indication 230461009
Dysmenorrhea indication 266599000
Influenza-like symptoms indication 315642008
Fever indication 386661006
Osteoarthritis indication 396275006 DOID:381
Juvenile rheumatoid arthritis indication 410795001
Acute postoperative pain indication 107401000119105
Necrotizing enterocolitis in fetus OR newborn contraindication 2707005 DOID:8677
Ocular hypertension contraindication 4210003 DOID:9282
Suicidal thoughts contraindication 6471006
Dependent drug abuse contraindication 6525002
Alcoholism contraindication 7200002
Alcohol withdrawal delirium contraindication 8635005
Peptic ulcer contraindication 13200003 DOID:750
Chronic obstructive lung disease contraindication 13645005 DOID:3083
Asthenia contraindication 13791008
Constipation contraindication 14760008 DOID:2089
Mood swings contraindication 18963009
Myocardial infarction contraindication 22298006 DOID:5844
Inflammatory bowel disease contraindication 24526004 DOID:0050589
Alcohol intoxication contraindication 25702006
Shock contraindication 27942005
Hypercapnia contraindication 29596007
Dehydration contraindication 34095006
Hyperthyroidism contraindication 34486009 DOID:7998
Hypertensive disorder contraindication 38341003 DOID:10763
Disorder of gallbladder contraindication 39621005 DOID:0060262
Gastrointestinal ulcer contraindication 40845000
Hypothyroidism contraindication 40930008 DOID:1459
Hypokalemia contraindication 43339004
Body fluid retention contraindication 43498006
Conduction disorder of the heart contraindication 44808001
Low blood pressure contraindication 45007003
Chronic heart failure contraindication 48447003
Bradycardia contraindication 48867003
Gastrointestinal perforation contraindication 51875005
Gastrectomy contraindication 53442002
Coronary arteriosclerosis contraindication 53741008 DOID:3393
Systemic lupus erythematosus contraindication 55464009 DOID:9074
Leber's optic atrophy contraindication 58610003 DOID:705
Hepatic failure contraindication 59927004
Ulcerative colitis contraindication 64766004 DOID:8577
Blood coagulation disorder contraindication 64779008 DOID:1247
Substance abuse contraindication 66214007
Benign intracranial hypertension contraindication 68267002 DOID:11459
Agoraphobia contraindication 70691001 DOID:593
Diabetes mellitus contraindication 73211009 DOID:9351
Gastrointestinal hemorrhage contraindication 74474003
Urethral stricture contraindication 76618002
Decreased respiratory function contraindication 80954004
Injury of head contraindication 82271004
Chronic idiopathic constipation contraindication 82934008
Cor pulmonale contraindication 83291003 DOID:8515
Atrophic gastritis contraindication 84568007 DOID:8929
Pulmonary emphysema contraindication 87433001
Kidney disease contraindication 90708001 DOID:2527
Acute abdominal pain contraindication 116290004
Gastrointestinal obstruction contraindication 126765001
Neoplasm of brain contraindication 126952004 DOID:1319
Seizure disorder contraindication 128613002 DOID:1826
Liver function tests abnormal contraindication 166603001
Drug-induced psychosis contraindication 191483003 DOID:1742
Obsessive-compulsive disorder contraindication 191736004 DOID:10933
Impaired renal function disorder contraindication 197663003
Cerebrovascular accident contraindication 230690007 DOID:6713
Coronary artery bypass graft contraindication 232717009
Disease of liver contraindication 235856003 DOID:409
Bladder outflow obstruction contraindication 236645006
Morbid obesity contraindication 238136002 DOID:11981
Benign prostatic hyperplasia contraindication 266569009 DOID:2883
Retention of urine contraindication 267064002
Anemia contraindication 271737000 DOID:2355
Exacerbation of asthma contraindication 281239006
Pregnancy, function contraindication 289908002
Lesion of brain contraindication 301766008
Thrombocytopenic disorder contraindication 302215000 DOID:1588
Thromboembolic disorder contraindication 371039008
Panic disorder contraindication 371631005 DOID:594
Coma contraindication 371632003
Primary adrenocortical insufficiency contraindication 373662000 DOID:13774
Operation on gastrointestinal tract contraindication 386621005
Hypoxia contraindication 389086002
Angle-closure glaucoma contraindication 392291006 DOID:13550
Cardiovascular event risk contraindication 395112001
Myocardial ischemia contraindication 414795007 DOID:3393
Myocardial infarction in recovery phase contraindication 418044006
Central nervous system depression contraindication 418072004
Dysfunction of sphincter of Oddi contraindication 430887001
Hypertensive urgency contraindication 443482000
Smokes tobacco daily contraindication 449868002
Significant Bleeding contraindication
Acute Thromboembolic Stroke contraindication

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 4.37 acidic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
EQ 20MG BASE/2ML (EQ 10MG BASE/ML) NEOPROFEN RECORDATI RARE N021903 April 13, 2006 RX INJECTABLE INTRAVENOUS 6342530 Nov. 14, 2020 CLOSURE OF A CLNICALLY SIGNIFICANT PATENT DUCTUS ARTERIOSUS IN PREMATURE INFANTS WEIGHING BETWEEN 500 AND 1500G, WHO ARE NO MORE THAN 32 WEEKS GESTATIONAL AGE WHEN USUAL MEDICAL MANAGEMENT IS INEFFECTIVE
EQ 20MG BASE/2ML (EQ 10MG BASE/ML) NEOPROFEN RECORDATI RARE N021903 April 13, 2006 RX INJECTABLE INTRAVENOUS 6342530 Nov. 14, 2020 TREATMENT OF PATENT DUCTUS ARTERIOSUS
EQ 20MG BASE/2ML (EQ 10MG BASE/ML) NEOPROFEN RECORDATI RARE N021903 April 13, 2006 RX INJECTABLE INTRAVENOUS 6344479 March 20, 2021 CLOSURE OF A CLNICALLY SIGNIFICANT PATENT DUCTUS ARTERIOSUS IN PREMATURE INFANTS WEIGHING BETWEEN 500 AND 1500G, WHO ARE NO MORE THAN 32 WEEKS GESTATIONAL AGE WHEN USUAL MEDICAL MANAGEMENT IS INEFFECTIVE
400MG/4ML (100MG/ML) CALDOLOR CUMBERLAND PHARMS N022348 June 11, 2009 DISCN SOLUTION INTRAVENOUS 6727286 Nov. 27, 2021 MANAGEMENT OF MILD TO MODERATE PAIN, MANAGEMENT OF MODERATE TO SEVERE PAIN AS AN ADJUNCT TO OPIOID ANALGESICS, REDUCTION IN FEVER THROUGH ANTI-INFLAMMATORY, ANALGESIC, AND ANTIPYRETIC ACTIVITY
800MG/8ML (100MG/ML) CALDOLOR CUMBERLAND PHARMS N022348 June 11, 2009 RX SOLUTION INTRAVENOUS 6727286 Nov. 27, 2021 MANAGEMENT OF MILD TO MODERATE PAIN, MANAGEMENT OF MODERATE TO SEVERE PAIN AS AN ADJUNCT TO OPIOID ANALGESICS, REDUCTION IN FEVER THROUGH ANTI-INFLAMMATORY, ANALGESIC, AND ANTIPYRETIC ACTIVITY
EQ 200MG FREE ACID AND POTASSIUM SALT ADVIL PM PFIZER N021393 Dec. 21, 2005 OTC CAPSULE ORAL 8883849 Jan. 17, 2022 A METHOD OF TREATING A PATIENT SUFFERING FROM A PAIN ASSOCIATED SLEEP DISTURBANCE COMPRISING ADMINISTERING A LIQUID COMPOSITION FORMULATED INSIDE A SOFT GEL CAPSULE, AS CLAIMED, TO THE PATIENT
800MG DUEXIS HORIZON PHARMA N022519 April 23, 2011 RX TABLET ORAL 8067451 July 18, 2026 RELIEF OF SIGNS AND SYMPTOMS OF RHEUMATOID ARTHRITIS AND OSTEOARTHRITIS AND TO DECREASE RISK OF DEVELOPING UPPER GASTROINTESTINAL ULCERS IN PATIENTS WHO ARE TAKING IBUPROFEN FOR THOSE INDICATIONS
800MG DUEXIS HORIZON PHARMA N022519 April 23, 2011 RX TABLET ORAL 8501228 July 18, 2026 RELIEF OF SIGNS AND SYMPTOMS OF RHEUMATOID ARTHRITIS AND OSTEOARTHRITIS AND TO DECREASE RISK OF DEVELOPING UPPER GASTROINTESTINAL ULCERS IN PATIENTS WHO ARE TAKING IBUPROFEN FOR THOSE INDICATIONS
800MG/8ML (100MG/ML) CALDOLOR CUMBERLAND PHARMS N022348 June 11, 2009 RX SOLUTION INTRAVENOUS 8735452 Sept. 30, 2029 MANAGEMENT OF MILD TO MODERATE PAIN, MANAGEMENT OF MODERATE TO SEVERE PAIN AS AN ADJUNCT TO OPIOID ANALGESICS, REDUCTION IN FEVER THROUGH ANTI-INFLAMMATORY, ANALGESIC, AND ANTIPYRETIC ACTIVITY
800MG/8ML (100MG/ML) CALDOLOR CUMBERLAND PHARMS N022348 June 11, 2009 RX SOLUTION INTRAVENOUS 8871810 Sept. 30, 2029 MANAGEMENT OF MILD TO MODERATE PAIN, MANAGEMENT OF MODERATE TO SEVERE PAIN AS AN ADNUNCT TO OPIOID ANALGESICS, REDUCTION IN FEVER THROUGH ANTI INFLAMMATORY, ANALGESIC, AND ANTIPYRETIC ACTIVITY
800MG/8ML (100MG/ML) CALDOLOR CUMBERLAND PHARMS N022348 June 11, 2009 RX SOLUTION INTRAVENOUS 9114068 Sept. 30, 2029 METHODS OF TREATING PAIN, INFLAMMATION AND/OR FEVER WITH INTRAVENOUS IBUPROFEN SUCH THAT MEAN ARTERIAL BLOOD PRESSURE DOES NOT INCREASE THE DOSAGE INTERVAL
800MG/8ML (100MG/ML) CALDOLOR CUMBERLAND PHARMS N022348 June 11, 2009 RX SOLUTION INTRAVENOUS 9138404 Sept. 30, 2029 METHODS OF TREATING PAIN, INFLAMMATION AND/OR FEVER IN A CRITICALLY ILL PATIENT WITH INTRAVENOUS IBUPROFEN IN NEED THEREOF
800MG/8ML (100MG/ML) CALDOLOR CUMBERLAND PHARMS N022348 June 11, 2009 RX SOLUTION INTRAVENOUS 9295639 Sept. 30, 2029 METHODS OF TREATING PAIN, INFLAMMATION AND/OR FEVER IN A CRITICALLY ILL PATIENT WITH INTRAVENOUS IBUPROFEN IN NEED THEREOF
800MG/8ML (100MG/ML) CALDOLOR CUMBERLAND PHARMS N022348 June 11, 2009 RX SOLUTION INTRAVENOUS 9649284 Sept. 30, 2029 MANAGEMENT OF MILD TO MODERATE PAIN, MANAGEMENT OF MODERATE TO SEVERE PAIN AS AN ADJUNCT TO OPIOID ANALGESICS IN A CRITICALLY ILL PATIENT WITH INTRAVENOUS IBUPROFEN IN NEED THEREOF
800MG/8ML (100MG/ML) CALDOLOR CUMBERLAND PHARMS N022348 June 11, 2009 RX SOLUTION INTRAVENOUS 9012508 Sept. 14, 2030 MANAGEMENT OF MILD TO MODERATE PAIN, MANAGEMENT OF MODERATE TO SEVERE PAIN AS AN ADJUNCT TO OPIOID ANALGESICS, REDUCTION IN FEVER THROUGH ANTI-INFLAMMATORY, ANALGESIC, AND ANTIPYRETIC ACTIVITY

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
800MG/8ML (100MG/ML) CALDOLOR CUMBERLAND PHARMS N022348 June 11, 2009 RX SOLUTION INTRAVENOUS Nov. 20, 2018 DOSING RECOMMENDATIONS AS NECESSARY FOR FEVER AND PAIN FOR AGES 6MO TO LESS THAN 12 YEARS AND 12 TO 17 YEARS.
800MG/8ML (100MG/ML) CALDOLOR CUMBERLAND PHARMS N022348 June 11, 2009 RX SOLUTION INTRAVENOUS Nov. 20, 2018 NEW PATIENT POPULATION

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Prostaglandin G/H synthase 2 Enzyme INHIBITOR IC50 5.14 WOMBAT-PK CHEMBL
Prostaglandin G/H synthase 1 Enzyme INHIBITOR IC50 5.12 WOMBAT-PK CHEMBL
Aldo-keto reductase family 1 member C3 Enzyme IC50 4.48 CHEMBL
Cytochrome P450 2C9 Enzyme Ki 4.30 WOMBAT-PK
Arachidonate 5-lipoxygenase Enzyme WOMBAT-PK
Sodium-coupled monocarboxylate transporter 1 Transporter INHIBITOR IC50 4.20 IUPHAR
Interleukin-8 Cytokine IC50 7.30 CHEMBL
Acid-sensing ion channel 1 Ion channel BLOCKER IC50 3.53 SCIENTIFIC LITERATURE
Aldo-keto reductase family 1 member C2 Enzyme IC50 4.37 CHEMBL
Prostaglandin G/H synthase 2 Enzyme IC50 5.96 CHEMBL
Prostaglandin G/H synthase 2 Enzyme IC50 6.07 CHEMBL
Serum albumin Secreted IC50 5.52 CHEMBL
Fatty acid-binding protein, liver Unclassified Ki 4.32 CHEMBL
Dehydrogenase/reductase SDR family member 9 Unclassified IC50 4 CHEMBL
Prostaglandin G/H synthase 1 Enzyme IC50 5.54 CHEMBL
Cyclooxygenase Enzyme IC50 5.70 CHEMBL
Prostaglandin G/H synthase 2 Enzyme Ki 5.05 CHEMBL
Solute carrier family 22 member 20 Transporter Ki 5.96 CHEMBL
Solute carrier family 22 member 6 Transporter Ki 5.33 CHEMBL
Prostaglandin G/H synthase 1 Enzyme Ki 5.05 CHEMBL
Prostaglandin-H2 D-isomerase Enzyme IC50 4.89 CHEMBL

External reference:

IDSource
2713 IUPHAR_LIGAND_ID
4032936 VUID
N0000189536 NUI
C0074814 UMLSCUI
D00126 KEGG_DRUG
CHEMBL521 ChEMBL_ID
DB01050 DRUGBANK_ID
3672 PUBCHEM_CID
2133 MMSL
5640 RXNORM
38268001 SNOMEDCT_US
387207008 SNOMEDCT_US
4862 MMSL
d00015 MMSL
7027 MMSL
4017840 VANDF
N0000006993 NDFRT
N0000146197 NDFRT
002377 NDDF
CHEMBL175 ChEMBL_ID
CHEMBL427526 ChEMBL_ID
CHEBI:132922 CHEBI
CHEMBL1201141 ChEMBL_ID
CHEMBL1241153 ChEMBL_ID
C016106 MESH_SUPPLEMENTAL_RECORD_UI
D007052 MESH_DESCRIPTOR_UI
N01ORX9D6S UNII
57469-77-9 SECONDARY_CAS_RN
2118 INN_ID
IBP PDB_CHEM_ID
IZP PDB_CHEM_ID

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Good Sense Infants Ibuprofen HUMAN OTC DRUG LABEL 1 0113-0040 SUSPENSION/ DROPS 50 mg ORAL ANDA 9 sections
good sense ibuprofen pm HUMAN OTC DRUG LABEL 2 0113-0050 TABLET, FILM COATED 200 mg ORAL ANDA 9 sections
Good Sense ibuprofen HUMAN OTC DRUG LABEL 1 0113-0057 SUSPENSION 50 mg ORAL ANDA 9 sections
Good Sense ibuprofen HUMAN OTC DRUG LABEL 1 0113-0074 TABLET, COATED 200 mg ORAL ANDA 9 sections
good sense ibuprofen HUMAN OTC DRUG LABEL 1 0113-0166 SUSPENSION 100 mg ORAL ANDA 9 sections
good sense ibuprofen HUMAN OTC DRUG LABEL 1 0113-0298 CAPSULE, LIQUID FILLED 200 mg ORAL ANDA 9 sections
Good Sense ibuprofen HUMAN OTC DRUG LABEL 1 0113-0461 TABLET, CHEWABLE 100 mg ORAL ANDA 9 sections
Good Sense ibuprofen HUMAN OTC DRUG LABEL 1 0113-0517 TABLET, FILM COATED 200 mg ORAL ANDA 9 sections
good sense ibuprofen HUMAN OTC DRUG LABEL 1 0113-0604 TABLET, FILM COATED 200 mg ORAL ANDA 9 sections
good sense ibuprofen HUMAN OTC DRUG LABEL 1 0113-0647 TABLET, FILM COATED 200 mg ORAL ANDA 9 sections
Good Sense Ibuprofen HUMAN OTC DRUG LABEL 1 0113-0660 SUSPENSION 100 mg ORAL ANDA 9 sections
Good Sense Ibuprofen HUMAN OTC DRUG LABEL 1 0113-0685 SUSPENSION 100 mg ORAL ANDA 9 sections
Basic Care ibuprofen HUMAN OTC DRUG LABEL 1 0113-0788 TABLET, CHEWABLE 100 mg ORAL ANDA 9 sections
good sense ibuprofen HUMAN OTC DRUG LABEL 1 0113-0897 SUSPENSION 100 mg ORAL ANDA 9 sections
good sense childrens ibuprofen oral suspension HUMAN OTC DRUG LABEL 1 0113-0911 SUSPENSION 100 mg ORAL ANDA 9 sections
basic care ibuprofen HUMAN OTC DRUG LABEL 1 0113-7131 CAPSULE, LIQUID FILLED 200 mg ORAL ANDA 9 sections
Basic Care Ibuprofen HUMAN OTC DRUG LABEL 1 0113-7604 TABLET, FILM COATED 200 mg ORAL ANDA 9 sections
Basic Care childrens ibuprofen HUMAN OTC DRUG LABEL 1 0113-7897 SUSPENSION 100 mg ORAL ANDA 9 sections
IBUPROFEN HUMAN PRESCRIPTION DRUG LABEL 1 0121-1548 SUSPENSION 100 mg ORAL ANDA 14 sections
Childrens Ibuprofen HUMAN OTC DRUG LABEL 1 0121-1836 SUSPENSION 100 mg ORAL ANDA 10 sections
IBUPROFEN HUMAN PRESCRIPTION DRUG LABEL 1 0121-4774 SUSPENSION 100 mg ORAL ANDA 14 sections
Ibuprofen HUMAN PRESCRIPTION DRUG LABEL 1 0179-0040 TABLET, FILM COATED 800 mg ORAL ANDA 14 sections
IBU HUMAN PRESCRIPTION DRUG LABEL 1 0179-0115 TABLET 600 mg ORAL ANDA 12 sections
IBU HUMAN PRESCRIPTION DRUG LABEL 1 0179-0119 TABLET 800 mg ORAL ANDA 12 sections
Oxycodone hydrochloride and Ibuprofen HUMAN PRESCRIPTION DRUG LABEL 2 0228-4029 TABLET, FILM COATED 400 mg ORAL ANDA 16 sections
IBUPROFEN HUMAN OTC DRUG LABEL 1 0363-0003 CAPSULE, LIQUID FILLED 200 mg ORAL ANDA 16 sections
Ibuprofen HUMAN OTC DRUG LABEL 1 0363-0040 SUSPENSION 100 mg ORAL ANDA 15 sections
Ibuprofen PM HUMAN OTC DRUG LABEL 2 0363-0050 TABLET, FILM COATED 200 mg ORAL ANDA 9 sections
Ibuprofen HUMAN OTC DRUG LABEL 1 0363-0057 SUSPENSION 50 mg ORAL ANDA 9 sections
walprofen congestion relief and pain HUMAN OTC DRUG LABEL 2 0363-0158 TABLET, FILM COATED 200 mg ORAL ANDA 16 sections