ibuprofen Indications/Contra | FAERs-F | FAERs-M | Orange Bk | 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 treatment 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
  • Status: OFP
    • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

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

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 2 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 0.04 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) 193.90 µM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 85 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution) 0.15 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 0.82 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) 1.60 hours Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
Jan. 19, 2018 PMDA Senju Pharmaceutical Co., Ltd.
Sept. 19, 1974 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 4376.28 27.37 1563 12327 45080 2299115
Completed suicide 2697.55 27.37 896 12994 20138 2324057
Toxicity to various agents 2381.52 27.37 916 12974 31838 2312357
Acute kidney injury 2137.01 27.37 813 13077 27309 2316886
Intentional overdose 2090.60 27.37 638 13252 10683 2333512
Overdose 1652.02 27.37 615 13275 19292 2324903
Vomiting 1574.47 27.37 873 13017 70729 2273466
Angioedema 1419.76 27.37 443 13447 7953 2336242
Suicide attempt 1201.84 27.37 420 13470 10862 2333333
Nausea 1016.60 27.37 786 13104 111403 2232792
Gastrointestinal haemorrhage 890.95 27.37 346 13544 12089 2332106
Urticaria 881.24 27.37 417 13473 23844 2320351
Abdominal pain upper 787.36 27.37 375 13515 21725 2322470
Tubulointerstitial nephritis 735.70 27.37 202 13688 2236 2341959
Haematemesis 712.15 27.37 221 13669 3861 2340334
Gastric ulcer 636.08 27.37 189 13701 2827 2341368
Metabolic acidosis 605.73 27.37 215 13675 5783 2338412
Drug interaction 593.11 27.37 340 13550 28823 2315372
Pruritus 580.50 27.37 387 13503 42953 2301242
Melaena 574.59 27.37 188 13702 3918 2340277
Hypotension 572.48 27.37 345 13545 32091 2312104
Somnolence 545.80 27.37 299 13591 23186 2321009
Cardiac arrest 523.75 27.37 251 13639 14679 2329516
Rash 523.74 27.37 412 13478 59146 2285049
Drug ineffective 509.88 27.37 511 13379 101113 2243082
Headache 508.13 27.37 459 13431 79720 2264475
Tachycardia 492.39 27.37 248 13642 16161 2328034
Pharyngitis 479.59 27.37 142 13748 2093 2342102
Coma 479.26 27.37 203 13687 8853 2335342
Stevens-Johnson syndrome 477.12 27.37 165 13725 4094 2340101
Abdominal pain 476.81 27.37 314 13576 34060 2310135
Toxic epidermal necrolysis 460.24 27.37 149 13741 2995 2341200
Abdominal discomfort 457.83 27.37 241 13649 17215 2326980
Dizziness 439.82 27.37 370 13520 58295 2285900
Gastritis 435.12 27.37 157 13733 4424 2339771
Drug abuse 421.01 27.37 202 13688 11824 2332371
Gastrointestinal pain 420.18 27.37 110 13780 996 2343199
Deafness transitory 417.16 27.37 79 13811 104 2344091
Dyspnoea 408.89 27.37 404 13486 78329 2265866
Anaemia 404.33 27.37 285 13605 34507 2309688
Aspirin-exacerbated respiratory disease 399.35 27.37 77 13813 119 2344076
Ear infection 372.56 27.37 130 13760 3311 2340884
Cardio-respiratory arrest 367.43 27.37 169 13721 8977 2335218
Upper gastrointestinal haemorrhage 364.40 27.37 113 13777 1961 2342234
Haematochezia 352.58 27.37 140 13750 5155 2339040
Condition aggravated 343.90 27.37 250 13640 31729 2312466
Renal failure 335.28 27.37 196 13694 17153 2327042
Respiratory arrest 331.69 27.37 140 13750 6038 2338157
Acute hepatic failure 329.58 27.37 111 13779 2531 2341664
Decreased appetite 329.23 27.37 234 13656 28657 2315538
Pyrexia 328.39 27.37 302 13588 53406 2290789
Lip swelling 326.32 27.37 129 13761 4692 2339503
Anaphylactic reaction 318.38 27.37 156 13734 9549 2334646
Weight decreased 316.84 27.37 227 13663 28144 2316051
Intentional product misuse 312.69 27.37 153 13737 9336 2334859
Hypersensitivity 303.67 27.37 206 13684 23387 2320808
Erythema 294.01 27.37 207 13683 24952 2319243
Abortion spontaneous 281.26 27.37 160 13730 13285 2330910
Alanine aminotransferase increased 277.55 27.37 161 13729 13871 2330324
Poisoning 276.50 27.37 99 13791 2721 2341474
Jaundice 276.38 27.37 119 13771 5389 2338806
Blood creatinine increased 271.78 27.37 144 13746 10389 2333806
Acute generalised exanthematous pustulosis 256.53 27.37 82 13808 1576 2342619
Duodenal ulcer 256.17 27.37 75 13815 1058 2343137
Shoulder arthroplasty 249.25 27.37 59 13831 335 2343860
Face oedema 247.55 27.37 100 13790 3848 2340347
Drug-induced liver injury 243.37 27.37 97 13793 3602 2340593
Hypophagia 242.85 27.37 99 13791 3901 2340294
Swelling face 242.67 27.37 129 13761 9364 2334831
Lip oedema 235.74 27.37 66 13824 785 2343410
Product prescribing error 227.88 27.37 87 13803 2873 2341322
Pain 224.25 27.37 263 13627 61594 2282601
Hypothermia 224.18 27.37 79 13811 2069 2342126
Asthma 221.50 27.37 129 13761 11185 2333010
Drug reaction with eosinophilia and systemic symptoms 218.45 27.37 101 13789 5417 2338778
Kounis syndrome 206.98 27.37 47 13843 215 2343980
Deafness 206.53 27.37 79 13811 2622 2341573
Asthenia 201.47 27.37 218 13672 46708 2297487
Eyelid oedema 197.90 27.37 76 13814 2550 2341645
Exposure during pregnancy 196.31 27.37 163 13727 25056 2319139
Depressed level of consciousness 196.19 27.37 104 13786 7500 2336695
Hepatitis cholestatic 194.63 27.37 61 13829 1096 2343099
Hypertension 192.81 27.37 167 13723 27194 2317001
Renal tubular necrosis 187.24 27.37 64 13826 1526 2342669
Dyspepsia 186.75 27.37 110 13780 9734 2334461
Off label use 184.95 27.37 261 13629 73337 2270858
Death 180.22 27.37 272 13618 81196 2262999
Gastrointestinal disorder 175.36 27.37 102 13788 8815 2335380
Hepatitis 172.94 27.37 90 13800 6247 2337948
Loss of consciousness 170.86 27.37 133 13757 18634 2325561
Hepatic failure 170.31 27.37 86 13804 5603 2338592
Duodenal ulcer perforation 169.99 27.37 42 13848 293 2343902
Diarrhoea 169.40 27.37 268 13622 83296 2260899
Poisoning deliberate 168.30 27.37 55 13835 1136 2343059
Confusional state 166.26 27.37 146 13744 24198 2319997
International normalised ratio increased 163.30 27.37 91 13799 7245 2336950
Coma scale abnormal 162.49 27.37 49 13841 769 2343426
Product use in unapproved indication 161.27 27.37 105 13785 11095 2333100
General physical health deterioration 159.53 27.37 114 13776 14025 2330170
Cholestasis 159.49 27.37 72 13818 3649 2340546
Rectal haemorrhage 159.31 27.37 83 13807 5773 2338422
Product administration error 158.62 27.37 73 13817 3870 2340325
Meningitis aseptic 158.53 27.37 46 13844 627 2343568
Agranulocytosis 157.62 27.37 70 13820 3412 2340783
Rash maculo-papular 156.42 27.37 74 13816 4178 2340017
Dysphagia 155.50 27.37 108 13782 12697 2331498
Intentional self-injury 155.44 27.37 73 13817 4054 2340141
Dehydration 154.81 27.37 135 13755 22160 2322035
Haemoglobin decreased 150.98 27.37 122 13768 18029 2326166
Aspartate aminotransferase increased 147.61 27.37 104 13786 12508 2331687
Hyperkalaemia 147.48 27.37 79 13811 5814 2338381
Lactic acidosis 146.29 27.37 76 13814 5254 2338941
Product use issue 146.27 27.37 102 13788 12067 2332128
Seizure 145.94 27.37 136 13754 24330 2319865
Accidental overdose 145.72 27.37 69 13821 3903 2340292
Faeces discoloured 145.25 27.37 59 13831 2300 2341895
Foot operation 144.82 27.37 44 13846 709 2343486
Gastritis erosive 144.63 27.37 45 13845 788 2343407
Medication error 144.54 27.37 79 13811 6052 2338143
Malaise 142.21 27.37 199 13691 55386 2288809
Acute respiratory distress syndrome 142.04 27.37 64 13826 3228 2340967
Nasal disorder 139.55 27.37 36 13854 305 2343890
Renal tubular acidosis 139.55 27.37 36 13854 305 2343890
Pancreatitis acute 138.50 27.37 66 13824 3787 2340408
Circulatory collapse 137.63 27.37 65 13825 3655 2340540
Electrocardiogram QT prolonged 136.95 27.37 83 13807 7731 2336464
Vanishing bile duct syndrome 136.29 27.37 31 13859 143 2344052
Bezoar 135.26 27.37 32 13858 181 2344014
Acidosis 133.58 27.37 50 13840 1560 2342635
Syncope 133.14 27.37 110 13780 16765 2327430
Musculoskeletal stiffness 131.86 27.37 96 13794 12151 2332044
Blood urea increased 127.28 27.37 61 13829 3544 2340651
Coagulopathy 126.92 27.37 57 13833 2852 2341343
Lethargy 126.03 27.37 82 13808 8648 2335547
Hepatitis acute 124.92 27.37 47 13843 1488 2342707
Agitation 124.39 27.37 89 13801 10962 2333233
Anaphylactic shock 123.05 27.37 63 13827 4223 2339972
Tachypnoea 121.15 27.37 51 13839 2178 2342017
Hypokalaemia 115.78 27.37 84 13806 10570 2333625
Renal impairment 115.24 27.37 82 13808 10010 2334185
Hepatocellular injury 114.66 27.37 59 13831 3996 2340199
Laryngeal oedema 114.20 27.37 42 13848 1246 2342949
Swollen tongue 112.70 27.37 64 13826 5279 2338916
Respiratory distress 112.42 27.37 63 13827 5066 2339129
Ulcer 112.25 27.37 46 13844 1834 2342361
Gastric ulcer haemorrhage 111.48 27.37 37 13853 803 2343392
Feeding disorder 109.13 27.37 42 13848 1416 2342779
Drug level increased 107.10 27.37 50 13840 2737 2341458
Oedema peripheral 106.32 27.37 113 13777 23650 2320545
Erythema multiforme 105.78 27.37 46 13844 2129 2342066
Hypertensive emergency 105.59 27.37 27 13863 220 2343975
Swelling 105.45 27.37 95 13795 16255 2327940
Oedema 105.34 27.37 78 13812 10125 2334070
Gastrooesophageal reflux disease 104.07 27.37 74 13816 9021 2335174
Haematuria 102.76 27.37 56 13834 4262 2339933
Labelled drug-drug interaction medication error 102.64 27.37 39 13851 1269 2342926
Self-medication 102.48 27.37 32 13858 567 2343628
Gastric disorder 102.07 27.37 53 13837 3657 2340538
Eye swelling 101.89 27.37 56 13834 4334 2339861
Heart rate increased 101.63 27.37 79 13811 11026 2333169
Drug intolerance 101.11 27.37 86 13804 13631 2330564
Shock 101.07 27.37 54 13836 3950 2340245
Incorrect dose administered 99.83 27.37 74 13816 9621 2334574
Generalised tonic-clonic seizure 99.13 27.37 59 13831 5313 2338882
Gastric haemorrhage 98.88 27.37 36 13854 1037 2343158
Hypoxia 98.56 27.37 62 13828 6165 2338030
Blood pressure decreased 98.49 27.37 72 13818 9164 2335031
C-reactive protein increased 98.31 27.37 62 13828 6193 2338002
Fixed eruption 97.55 27.37 24 13866 164 2344031
Eye disorder 97.30 27.37 49 13841 3170 2341025
Wheezing 97.15 27.37 62 13828 6322 2337873
Fatigue 96.99 27.37 213 13677 84660 2259535
Drug dependence 96.90 27.37 48 13842 2997 2341198
Rhabdomyolysis 96.82 27.37 63 13827 6641 2337554
Drug eruption 96.73 27.37 49 13841 3210 2340985
Therapeutic product effect incomplete 96.55 27.37 75 13815 10456 2333739
Flank pain 96.33 27.37 39 13851 1506 2342689
Tinnitus 96.33 27.37 57 13833 5078 2339117
Inflammation 96.19 27.37 61 13829 6152 2338043
Oesophagitis 96.17 27.37 42 13848 1964 2342231
Cough 95.83 27.37 126 13764 32991 2311204
Nephropathy toxic 95.30 27.37 36 13854 1152 2343043
Deep vein thrombosis 95.15 27.37 81 13809 12851 2331344
Musculoskeletal disorder 92.97 27.37 44 13846 2484 2341711
Arthralgia 92.11 27.37 161 13729 54124 2290071
Arthropathy 91.81 27.37 63 13827 7253 2336942
Duodenal ulcer haemorrhage 91.78 27.37 27 13863 387 2343808
Gastrointestinal sounds abnormal 91.23 27.37 29 13861 546 2343649
Proteinuria 90.91 27.37 45 13845 2805 2341390
Enthesopathy 90.11 27.37 22 13868 145 2344050
Unresponsive to stimuli 88.53 27.37 53 13837 4823 2339372
Electrocardiogram QRS complex prolonged 86.98 27.37 33 13857 1069 2343126
Respiratory failure 86.03 27.37 78 13812 13450 2330745
Brain injury 85.30 27.37 31 13859 888 2343307
Pneumonia 84.64 27.37 147 13743 49149 2295046
Brain oedema 84.32 27.37 40 13850 2270 2341925
Anuria 83.59 27.37 37 13853 1787 2342408
Throat tightness 82.57 27.37 49 13841 4387 2339808
Gamma-glutamyltransferase increased 82.11 27.37 53 13837 5509 2338686
Adverse reaction 81.95 27.37 35 13855 1549 2342646
Iron deficiency anaemia 81.71 27.37 38 13852 2061 2342134
Sinus tachycardia 81.56 27.37 44 13846 3281 2340914
Gastric ulcer perforation 81.47 27.37 22 13868 226 2343969
Gastric perforation 81.26 27.37 23 13867 285 2343910
Transaminases increased 81.05 27.37 49 13841 4538 2339657
Abdominal pain lower 80.97 27.37 42 13848 2891 2341304
Chromaturia 80.56 27.37 41 13849 2712 2341483
Tongue oedema 80.12 27.37 29 13861 821 2343374
White blood cell count increased 79.61 27.37 57 13833 7021 2337174
Hepatic necrosis 79.60 27.37 31 13859 1079 2343116
Pharyngeal oedema 79.52 27.37 44 13846 3449 2340746
Brain death 79.22 27.37 26 13864 544 2343651
Haemodialysis 79.13 27.37 37 13853 2032 2342163
Dactylitis 78.78 27.37 18 13872 85 2344110
Liver injury 78.18 27.37 38 13852 2276 2341919
Eosinophilia 77.62 27.37 41 13849 2929 2341266
Bronchospasm 76.93 27.37 41 13849 2983 2341212
Palpitations 76.68 27.37 80 13810 16376 2327819
Dysarthria 76.09 27.37 53 13837 6249 2337946
Jejunal ulcer 74.65 27.37 15 13875 32 2344163
Dermatitis bullous 73.76 27.37 32 13858 1472 2342723
Suicidal ideation 72.60 27.37 65 13825 11022 2333173
Ataxia 72.59 27.37 37 13853 2455 2341740
Sepsis 72.38 27.37 82 13808 18406 2325789
Thrombocytopenia 71.77 27.37 83 13807 19048 2325147
Functional gastrointestinal disorder 71.67 27.37 23 13867 447 2343748
Hyponatraemia 71.63 27.37 70 13820 13255 2330940
Pulseless electrical activity 71.56 27.37 28 13862 987 2343208
Lymphadenopathy 71.33 27.37 49 13841 5649 2338546
Hepatic function abnormal 70.68 27.37 50 13840 6042 2338153
Mydriasis 70.66 27.37 35 13855 2184 2342011
Blister 70.40 27.37 52 13838 6719 2337476
Miosis 69.85 27.37 29 13861 1195 2343000
Synovitis 69.45 27.37 37 13853 2689 2341506
Blood pressure increased 67.62 27.37 76 13814 16910 2327285
Mental status changes 67.51 27.37 47 13843 5535 2338660
Blood alkaline phosphatase increased 67.46 27.37 50 13840 6495 2337700
Insomnia 66.77 27.37 93 13797 25694 2318501
Hyperhidrosis 66.57 27.37 72 13818 15350 2328845
Blood bicarbonate decreased 66.12 27.37 22 13868 481 2343714
Discomfort 66.08 27.37 45 13845 5114 2339081
Contraindicated product administered 65.89 27.37 37 13853 2984 2341211
Peripheral swelling 65.43 27.37 76 13814 17521 2326674
Necrotising fasciitis 65.41 27.37 22 13868 498 2343697
Oesophageal ulcer 65.02 27.37 24 13866 719 2343476
Purpura 65.01 27.37 31 13859 1779 2342416
Multiple organ dysfunction syndrome 64.82 27.37 52 13838 7589 2336606
Periorbital oedema 64.51 27.37 26 13864 992 2343203
Toxic skin eruption 64.21 27.37 33 13857 2227 2341968
Haemodynamic instability 64.14 27.37 27 13863 1152 2343043
Muscular weakness 63.34 27.37 69 13821 14828 2329367
Rash erythematous 62.37 27.37 46 13844 5930 2338265
Hyperlactacidaemia 62.30 27.37 20 13870 389 2343806
Allergy test positive 60.57 27.37 13 13877 43 2344152
Rash macular 60.53 27.37 37 13853 3494 2340701
Acute respiratory failure 60.33 27.37 35 13855 3003 2341192
Hyperventilation 59.78 27.37 26 13864 1203 2342992
C-reactive protein abnormal 59.73 27.37 23 13867 776 2343419
Dermatitis exfoliative 59.54 27.37 26 13864 1215 2342980
Aggression 59.53 27.37 41 13849 4745 2339450
Pancytopenia 59.39 27.37 59 13831 11393 2332802
Liver function test abnormal 59.38 27.37 49 13841 7441 2336754
Haemorrhage 59.34 27.37 58 13832 10981 2333214
Back pain 59.02 27.37 98 13792 31561 2312634
Feeling hot 58.45 27.37 47 13843 6881 2337314
Leukocytosis 57.57 27.37 36 13854 3540 2340655
Gastrointestinal ulcer 57.12 27.37 18 13872 329 2343866
Blood sodium decreased 57.06 27.37 34 13856 3066 2341129
Cellulitis 56.42 27.37 52 13838 9149 2335046
Sopor 56.34 27.37 37 13853 3958 2340237
Osteoarthritis 56.23 27.37 46 13844 6900 2337295
Localised oedema 55.97 27.37 22 13868 785 2343410
Loss of personal independence in daily activities 55.69 27.37 41 13849 5270 2338925
Cardiogenic shock 55.66 27.37 31 13859 2460 2341735
Septic shock 55.61 27.37 46 13844 7008 2337187
Blood bilirubin increased 55.45 27.37 41 13849 5304 2338891
Ulcer haemorrhage 55.29 27.37 20 13870 565 2343630
Abnormal behaviour 55.05 27.37 39 13851 4721 2339474
Depression 55.03 27.37 89 13801 28043 2316152
Blood loss anaemia 54.97 27.37 24 13866 1121 2343074
Anal haemorrhage 54.93 27.37 17 13873 292 2343903
Myalgia 54.30 27.37 80 13810 23253 2320942
Lower gastrointestinal haemorrhage 54.21 27.37 23 13867 1001 2343194
Conjunctivitis 54.07 27.37 30 13860 2363 2341832
Duodenitis 54.04 27.37 19 13871 493 2343702
Biliary sepsis 53.73 27.37 13 13877 82 2344113
Chest pain 53.66 27.37 88 13802 28049 2316146
Shock haemorrhagic 52.35 27.37 24 13866 1259 2342936
Kidney enlargement 52.18 27.37 14 13876 140 2344055
Rhinitis 52.05 27.37 23 13867 1106 2343089
Reaction to excipient 52.00 27.37 17 13873 351 2343844
Pulmonary oedema 51.86 27.37 45 13845 7318 2336877
Autoimmune hepatitis 51.80 27.37 26 13864 1669 2342526
Hepatic enzyme increased 51.75 27.37 51 13839 9751 2334444
Blood lactic acid increased 51.40 27.37 21 13869 830 2343365
Fall 51.16 27.37 116 13774 46983 2297212
Blood lactate dehydrogenase increased 50.92 27.37 33 13857 3451 2340744
Liver disorder 50.92 27.37 42 13848 6372 2337823
Red blood cell sedimentation rate 50.20 27.37 10 13880 20 2344175
Renal papillary necrosis 49.82 27.37 11 13879 43 2344152
Product monitoring error 49.78 27.37 13 13877 116 2344079
Neutrophilia 49.74 27.37 18 13872 509 2343686
Product administered to patient of inappropriate age 49.59 27.37 20 13870 764 2343431
Hiatus hernia 49.49 27.37 27 13863 2057 2342138
Palatal oedema 49.27 27.37 14 13876 176 2344019
Disturbance in attention 48.88 27.37 39 13851 5646 2338549
Gastritis haemorrhagic 48.61 27.37 15 13875 255 2343940
Product communication issue 48.38 27.37 10 13880 26 2344169
Chills 47.77 27.37 61 13829 15491 2328704
Intestinal perforation 47.58 27.37 25 13865 1766 2342429
Peptic ulcer 47.49 27.37 18 13872 581 2343614
Analgesic drug level increased 47.45 27.37 15 13875 277 2343918
Colitis 47.40 27.37 37 13853 5189 2339006
Gastrointestinal inflammation 47.38 27.37 19 13871 715 2343480
Varicella 47.24 27.37 16 13874 370 2343825
Eating disorder 47.22 27.37 27 13863 2254 2341941
Dermo-hypodermitis 47.14 27.37 11 13879 58 2344137
Anxiety 47.02 27.37 85 13805 29274 2314921
Paraesthesia 46.10 27.37 72 13818 22016 2322179
Foetal death 46.04 27.37 25 13865 1887 2342308
Chest discomfort 46.02 27.37 58 13832 14537 2329658
Hypoaldosteronism 45.94 27.37 10 13880 36 2344159
Hypersensitivity vasculitis 45.85 27.37 22 13868 1280 2342915
Joint swelling 45.53 27.37 62 13828 16757 2327438
Pain in extremity 45.33 27.37 104 13786 42436 2301759
Embolism venous 45.16 27.37 15 13875 326 2343869
Abnormal loss of weight 45.15 27.37 18 13872 667 2343528
Poor quality product administered 45.12 27.37 19 13871 811 2343384
Mucous stools 45.04 27.37 15 13875 329 2343866
Dysuria 44.91 27.37 32 13858 3909 2340286
Polyuria 44.77 27.37 21 13869 1161 2343034
Epistaxis 44.56 27.37 47 13843 9732 2334463
Haematocrit decreased 44.52 27.37 33 13857 4285 2339910
Tremor 44.03 27.37 68 13822 20593 2323602
Haematoma 43.74 27.37 35 13855 5086 2339109
Toxic shock syndrome streptococcal 43.65 27.37 9 13881 23 2344172
Abscess rupture 43.63 27.37 10 13880 48 2344147
Blood pH decreased 43.48 27.37 16 13874 475 2343720
Pneumonia pneumococcal 43.24 27.37 14 13876 280 2343915
Rash pruritic 43.15 27.37 41 13849 7494 2336701
Dysphonia 43.02 27.37 38 13852 6326 2337869
Glomerular filtration rate decreased 42.99 27.37 22 13868 1471 2342724
Arrhythmia 42.77 27.37 37 13853 5991 2338204
Fibromyalgia 42.77 27.37 29 13861 3271 2340924
Tenosynovitis 42.70 27.37 16 13874 500 2343695
Arthritis 42.06 27.37 46 13844 9922 2334273
Bradycardia 42.01 27.37 46 13844 9935 2334260
Haemarthrosis 41.89 27.37 15 13875 411 2343784
Dry mouth 41.82 27.37 42 13848 8211 2335984
Pallor 41.75 27.37 30 13860 3712 2340483
Substance abuse 41.74 27.37 16 13874 533 2343662
Oesophageal discomfort 41.48 27.37 10 13880 62 2344133
Hepatic encephalopathy 41.46 27.37 22 13868 1585 2342610
Hepatotoxicity 41.36 27.37 29 13861 3452 2340743
Obstruction gastric 41.04 27.37 12 13878 168 2344027
Duodenitis haemorrhagic 40.85 27.37 8 13882 14 2344181
Granuloma skin 40.82 27.37 11 13879 112 2344083
Infection 40.76 27.37 61 13829 17968 2326227
Product quality issue 40.62 27.37 47 13843 10782 2333413
Photosensitivity reaction 40.50 27.37 25 13865 2402 2341793
Drug screen positive 40.03 27.37 18 13872 902 2343293
Gastroenteritis 39.91 27.37 27 13863 3033 2341162
Ductus arteriosus premature closure 39.83 27.37 9 13881 40 2344155
Cerebral haemorrhage 39.49 27.37 34 13856 5470 2338725
Hypoglycaemia 39.36 27.37 41 13849 8366 2335829
Large intestinal ulcer 39.35 27.37 15 13875 492 2343703
Oliguria 39.09 27.37 20 13870 1337 2342858
Constipation 39.01 27.37 66 13824 21563 2322632
Vasculitis 38.99 27.37 24 13866 2294 2341901
Altered state of consciousness 38.67 27.37 29 13861 3831 2340364
Urinary tract infection 38.51 27.37 79 13811 29863 2314332
Thyroid stimulating immunoglobulin increased 38.49 27.37 7 13883 6 2344189
Gait disturbance 38.31 27.37 67 13823 22478 2321717
Epigastric discomfort 38.06 27.37 15 13875 539 2343656
Duodenal stenosis 37.92 27.37 10 13880 93 2344102
Prothrombin time prolonged 37.82 27.37 21 13869 1656 2342539
Sedation 37.62 27.37 27 13863 3335 2340860
Status epilepticus 37.52 27.37 24 13866 2454 2341741
Anti-thyroid antibody positive 37.36 27.37 10 13880 99 2344096
Hypertensive crisis 37.21 27.37 24 13866 2489 2341706
Activated partial thromboplastin time prolonged 37.19 27.37 19 13871 1266 2342929
Milk-alkali syndrome 36.75 27.37 10 13880 106 2344089
Rheumatoid arthritis 36.65 27.37 60 13830 19080 2325115
Evans syndrome 36.64 27.37 9 13881 61 2344134
Infected dermal cyst 36.64 27.37 9 13881 61 2344134
Tongue disorder 36.61 27.37 18 13872 1105 2343090
Colitis microscopic 36.60 27.37 17 13873 919 2343276
Hypercalcaemia 36.53 27.37 24 13866 2568 2341627
Weight increased 36.17 27.37 65 13825 22272 2321923
Protein-losing gastroenteropathy 36.14 27.37 9 13881 65 2344130
Mouth ulceration 36.13 27.37 28 13862 3884 2340311
Renal ischaemia 36.02 27.37 9 13881 66 2344129
Obstructive airways disorder 36.00 27.37 19 13871 1354 2342841
Thrombotic thrombocytopenic purpura 35.94 27.37 16 13874 783 2343412
Corneal leukoma 35.84 27.37 7 13883 12 2344183
Red blood cell sedimentation rate increased 35.62 27.37 22 13868 2115 2342080
Haemolytic anaemia 35.58 27.37 21 13869 1860 2342335
Respiratory acidosis 35.52 27.37 16 13874 805 2343390
Pharyngeal paraesthesia 35.39 27.37 10 13880 123 2344072
Chronic kidney disease 34.86 27.37 28 13862 4090 2340105
Bone loss 34.81 27.37 14 13876 531 2343664
Staphylococcal scalded skin syndrome 34.80 27.37 8 13882 39 2344156
Migraine 34.64 27.37 43 13847 10610 2333585
Psychomotor skills impaired 34.61 27.37 13 13877 409 2343786
Adverse drug reaction 34.56 27.37 38 13852 8245 2335950
Blood parathyroid hormone decreased 34.41 27.37 11 13879 211 2343984
Peritonitis 34.26 27.37 23 13867 2551 2341644
Small intestinal haemorrhage 34.25 27.37 12 13878 308 2343887
Mycoplasma infection 34.20 27.37 9 13881 83 2344112
Serotonin syndrome 34.15 27.37 26 13864 3514 2340681
Skin exfoliation 34.09 27.37 32 13858 5758 2338437
Dysgeusia 33.90 27.37 38 13852 8421 2335774
Dry eye 33.71 27.37 27 13863 3929 2340266
Rash papular 33.70 27.37 23 13867 2621 2341574
Feeling abnormal 33.66 27.37 65 13825 23516 2320679
Drug ineffective for unapproved indication 33.60 27.37 24 13866 2942 2341253
Hepatosplenomegaly 33.07 27.37 13 13877 464 2343731
Exposure via ingestion 32.96 27.37 15 13875 773 2343422
Respiratory depression 32.81 27.37 21 13869 2149 2342046
Blood glucose increased 32.79 27.37 45 13845 12245 2331950
Blood creatine increased 32.47 27.37 14 13876 634 2343561
Ductus arteriosus stenosis foetal 32.42 27.37 7 13883 24 2344171
Acute left ventricular failure 32.29 27.37 9 13881 105 2344090
Platelet count increased 32.23 27.37 21 13869 2216 2341979
Urinary incontinence 32.10 27.37 27 13863 4206 2339989
Neonatal cardiac failure 32.07 27.37 6 13884 7 2344188
Erosive duodenitis 31.90 27.37 9 13881 110 2344085
Acute myocardial infarction 31.82 27.37 29 13861 5026 2339169
Glomerulonephritis chronic 31.78 27.37 7 13883 27 2344168
Patient uncooperative 31.78 27.37 7 13883 27 2344168
Viral infection 31.76 27.37 28 13862 4648 2339547
Streptococcal infection 31.59 27.37 15 13875 852 2343343
Oral discomfort 31.27 27.37 17 13873 1286 2342909
Petechiae 31.20 27.37 20 13870 2052 2342143
Intestinal ischaemia 31.19 27.37 16 13874 1075 2343120
Skin ulcer 31.01 27.37 26 13864 4033 2340162
Substance dependence 30.82 27.37 7 13883 32 2344163
Electrocardiogram abnormal 30.73 27.37 17 13873 1331 2342864
Still's disease 30.72 27.37 9 13881 127 2344068
Intestinal diaphragm disease 30.64 27.37 7 13883 33 2344162
Abscess 30.64 27.37 21 13869 2410 2341785
Peritonsillar abscess 30.59 27.37 9 13881 129 2344066
Renal cyst 30.50 27.37 16 13874 1126 2343069
Product taste abnormal 30.50 27.37 13 13877 572 2343623
Sensory loss 30.47 27.37 16 13874 1128 2343067
Diarrhoea haemorrhagic 30.44 27.37 17 13873 1356 2342839
Restlessness 30.34 27.37 27 13863 4536 2339659
Influenza like illness 30.30 27.37 43 13847 12071 2332124
Ear swelling 30.21 27.37 10 13880 215 2343980
Pharyngeal abscess 30.09 27.37 8 13882 77 2344118
Rheumatoid nodule 29.81 27.37 13 13877 605 2343590
Psoriatic arthropathy 29.76 27.37 25 13865 3889 2340306
Leukopenia 29.75 27.37 39 13851 10157 2334038
Genital odour 29.67 27.37 5 13885 1 2344194
Creatinine renal clearance abnormal 29.64 27.37 8 13882 82 2344113
Urinary hesitation 29.58 27.37 10 13880 230 2343965
Intentional product use issue 29.45 27.37 24 13866 3578 2340617
Abnormal clotting factor 29.37 27.37 7 13883 41 2344154
Paraesthesia oral 29.34 27.37 20 13870 2274 2341921
Diverticulum 29.26 27.37 17 13873 1462 2342733
Non-cardiac chest pain 29.15 27.37 14 13876 816 2343379
Maternal exposure during pregnancy 29.00 27.37 47 13843 14816 2329379
Anal incontinence 28.92 27.37 18 13872 1754 2342441
Joint effusion 28.83 27.37 16 13874 1260 2342935
Disseminated intravascular coagulation 28.83 27.37 23 13867 3327 2340868
Globulins decreased 28.82 27.37 7 13883 45 2344150
Vulval disorder 28.68 27.37 9 13881 162 2344033
Oxygen saturation decreased 28.57 27.37 33 13857 7553 2336642
Hyperbilirubinaemia 28.53 27.37 17 13873 1532 2342663
Genital tract inflammation 28.40 27.37 6 13884 18 2344177
Blood pressure diastolic decreased 28.28 27.37 15 13875 1080 2343115
Panniculitis 28.26 27.37 12 13878 523 2343672
Acute coronary syndrome 28.25 27.37 17 13873 1560 2342635
Stubbornness 28.15 27.37 6 13884 19 2344176
Haemorrhagic diathesis 28.11 27.37 12 13878 530 2343665
Spinal pain 28.05 27.37 16 13874 1329 2342866
Haemoptysis 27.79 27.37 23 13867 3504 2340691
Colitis ischaemic 27.66 27.37 17 13873 1620 2342575
Urogenital haemorrhage 27.48 27.37 6 13884 22 2344173

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 2097.99 31.19 898 9348 34046 1702489
Drug hypersensitivity 1526.66 31.19 568 9678 14567 1721968
Completed suicide 1395.44 31.19 543 9703 15769 1720766
Toxicity to various agents 1368.67 31.19 633 9613 28508 1708027
Angioedema 1259.13 31.19 439 9807 9225 1727310
Intentional overdose 1015.53 31.19 353 9893 7317 1729218
Gastrointestinal haemorrhage 941.82 31.19 395 9851 13872 1722663
Haematemesis 916.11 31.19 285 9961 4092 1732443
Suicide attempt 829.59 31.19 301 9945 7080 1729455
Overdose 786.82 31.19 365 9881 16336 1720199
Melaena 783.26 31.19 264 9982 4946 1731589
Urticaria 652.97 31.19 292 9954 11949 1724586
Vomiting 612.95 31.19 411 9835 37904 1698631
Gastric ulcer 565.98 31.19 176 10070 2509 1734026
Gastric haemorrhage 548.03 31.19 176 10070 2802 1733733
Upper gastrointestinal haemorrhage 478.00 31.19 159 10087 2840 1733695
Gastritis 444.44 31.19 152 10094 2965 1733570
Metabolic acidosis 438.57 31.19 174 10072 5228 1731307
Duodenal ulcer 420.13 31.19 127 10119 1633 1734902
Nausea 377.34 31.19 348 9898 50848 1685687
Drug interaction 370.84 31.19 268 9978 27690 1708845
Abdominal pain upper 365.59 31.19 190 10056 10811 1725724
Abdominal pain 345.64 31.19 232 10014 21258 1715277
Tubulointerstitial nephritis 344.06 31.19 124 10122 2834 1733701
Hypotension 338.94 31.19 260 9986 29394 1707141
Anaemia 338.28 31.19 259 9987 29198 1707337
Dizziness 321.77 31.19 268 9978 34093 1702442
Aspirin-exacerbated respiratory disease 309.87 31.19 60 10186 68 1736467
Dyspnoea 306.38 31.19 313 9933 51746 1684789
Toxic epidermal necrolysis 304.52 31.19 107 10139 2264 1734271
Pruritus 301.67 31.19 220 10026 23002 1713533
Rash 294.14 31.19 268 9978 38425 1698110
Faeces discoloured 291.67 31.19 104 10142 2300 1734235
Hypersensitivity 289.62 31.19 160 10086 10284 1726251
Condition aggravated 282.89 31.19 204 10042 20946 1715589
Intentional product misuse 281.90 31.19 140 10106 7218 1729317
Anaphylactic reaction 275.47 31.19 130 10116 5983 1730552
Drug abuse 261.99 31.19 165 10081 13524 1723011
Coma 260.03 31.19 132 10114 7130 1729405
Stevens-Johnson syndrome 257.88 31.19 104 10142 3253 1733282
Renal failure 253.83 31.19 187 10059 19830 1716705
Poisoning 242.31 31.19 92 10154 2440 1734095
Duodenal ulcer haemorrhage 242.21 31.19 69 10177 708 1735827
Pyrexia 240.52 31.19 261 9985 46139 1690396
Lip oedema 239.57 31.19 65 10181 548 1735987
Headache 237.61 31.19 226 10020 34150 1702385
Renal tubular necrosis 232.04 31.19 85 10161 2034 1734501
Gastric ulcer haemorrhage 229.35 31.19 70 10176 929 1735606
Asthma 229.24 31.19 107 10139 4797 1731738
Hyperkalaemia 228.81 31.19 128 10118 8419 1728116
Gastritis erosive 227.31 31.19 69 10177 898 1735637
Haematochezia 225.57 31.19 106 10140 4826 1731709
Haemoglobin decreased 214.86 31.19 159 10087 16955 1719580
Pain 210.69 31.19 189 10057 26468 1710067
Somnolence 208.97 31.19 155 10091 16584 1719951
Blood creatinine increased 205.84 31.19 143 10103 13803 1722732
Duodenal ulcer perforation 194.91 31.19 48 10198 262 1736273
Peptic ulcer 194.15 31.19 53 10193 458 1736077
Enthesopathy 187.51 31.19 38 10208 64 1736471
Drug ineffective 175.73 31.19 262 9984 63539 1672996
Lip swelling 175.46 31.19 75 10171 2720 1733815
Rectal haemorrhage 173.20 31.19 92 10154 5450 1731085
Gastric ulcer perforation 172.59 31.19 40 10206 160 1736375
Renal papillary necrosis 172.12 31.19 32 10214 23 1736512
Drug-induced liver injury 171.23 31.19 77 10169 3160 1733375
Acute hepatic failure 169.71 31.19 67 10179 1976 1734559
Erythema 169.46 31.19 128 10118 14060 1722475
Tachycardia 162.13 31.19 119 10127 12509 1724026
Face oedema 161.02 31.19 67 10179 2269 1734266
Renal impairment 155.74 31.19 115 10131 12199 1724336
Duodenitis 155.47 31.19 47 10199 602 1735933
Meningitis aseptic 154.18 31.19 44 10202 454 1736081
Product use in unapproved indication 154.08 31.19 103 10143 9319 1727216
Agitation 150.85 31.19 108 10138 10918 1725617
Diarrhoea 150.75 31.19 223 10023 53629 1682906
Anuria 150.13 31.19 60 10186 1828 1734707
Cardio-respiratory arrest 145.76 31.19 99 10147 9194 1727341
Eyelid oedema 144.93 31.19 53 10193 1260 1735275
Hyperhidrosis 143.21 31.19 110 10136 12378 1724157
Tenosynovitis 142.36 31.19 37 10209 259 1736276
C-reactive protein abnormal 136.31 31.19 35 10211 232 1736303
Intestinal diaphragm disease 136.14 31.19 27 10219 38 1736497
Erythema multiforme 133.68 31.19 54 10192 1692 1734843
Hypothermia 133.62 31.19 54 10192 1694 1734841
Product prescribing error 132.78 31.19 59 10187 2351 1734184
Wheezing 132.72 31.19 70 10176 4083 1732452
Malaise 130.00 31.19 153 10093 29412 1707123
Dehydration 125.25 31.19 118 10128 17540 1718995
Alanine aminotransferase increased 123.22 31.19 100 10146 12178 1724357
Haematuria 122.01 31.19 82 10164 7478 1729057
Rash maculo-papular 119.98 31.19 63 10183 3640 1732895
Syncope 118.72 31.19 104 10142 14065 1722470
Off label use 118.34 31.19 167 10079 38404 1698131
Tongue oedema 115.67 31.19 37 10209 577 1735958
Respiratory arrest 115.55 31.19 72 10174 5767 1730768
Tongue disorder 115.22 31.19 36 10210 518 1736017
Synovitis 112.58 31.19 38 10208 707 1735828
Cardiac arrest 112.08 31.19 106 10140 15824 1720711
Haemorrhage 111.37 31.19 86 10160 9743 1726792
Jaundice 110.59 31.19 71 10175 5991 1730544
Iron deficiency anaemia 106.17 31.19 41 10205 1137 1735398
Agranulocytosis 105.04 31.19 57 10189 3519 1733016
Loss of consciousness 102.76 31.19 98 10148 14777 1721758
Loss of personal independence in daily activities 101.77 31.19 49 10197 2350 1734185
Drug reaction with eosinophilia and systemic symptoms 101.53 31.19 63 10183 5007 1731528
Oesophagitis 101.32 31.19 44 10202 1657 1734878
Nasal disorder 100.78 31.19 26 10220 176 1736359
Chest discomfort 100.64 31.19 72 10174 7259 1729276
Erosive oesophagitis 100.36 31.19 28 10218 264 1736271
Hepatitis acute 100.10 31.19 40 10206 1217 1735318
Conjunctivitis 99.85 31.19 43 10203 1586 1734949
Asthenia 98.79 31.19 145 10101 34525 1702010
Acute generalised exanthematous pustulosis 97.39 31.19 38 10208 1084 1735451
Accidental overdose 96.95 31.19 57 10189 4107 1732428
Aspartate aminotransferase increased 96.24 31.19 82 10164 10674 1725861
Dysphagia 96.09 31.19 80 10166 10088 1726447
Rhabdomyolysis 96.09 31.19 83 10163 11007 1725528
Self-medication 96.05 31.19 33 10213 649 1735886
Macrocephaly 95.48 31.19 20 10226 43 1736492
Palatal oedema 95.08 31.19 26 10220 226 1736309
Blood urea increased 92.97 31.19 58 10188 4653 1731882
Gastritis haemorrhagic 92.92 31.19 26 10220 248 1736287
Medication error 92.61 31.19 58 10188 4685 1731850
Fixed eruption 91.97 31.19 25 10221 212 1736323
Apnoea 91.29 31.19 39 10207 1410 1735125
General physical health deterioration 89.78 31.19 86 10160 13032 1723503
Eye swelling 89.36 31.19 42 10204 1907 1734628
Hypertension 89.28 31.19 103 10143 19345 1717190
Product quality issue 88.62 31.19 62 10184 6031 1730504
Swelling face 87.97 31.19 55 10191 4428 1732107
Leukocytosis 86.57 31.19 50 10196 3483 1733052
Alanine aminotransferase abnormal 86.53 31.19 24 10222 221 1736314
Product use issue 86.35 31.19 70 10176 8501 1728034
Acute respiratory distress syndrome 86.34 31.19 50 10196 3501 1733034
Jejunal ulcer perforation 86.05 31.19 15 10231 3 1736532
Sopor 85.26 31.19 41 10205 1960 1734575
Pyloric stenosis 85.13 31.19 22 10224 150 1736385
Milk-alkali syndrome 84.51 31.19 19 10227 64 1736471
Ulcer 82.06 31.19 34 10212 1137 1735398
Peritonitis 81.38 31.19 44 10202 2695 1733840
Cough 80.37 31.19 97 10149 19100 1717435
Transaminases increased 79.24 31.19 49 10197 3868 1732667
Hepatitis 78.13 31.19 53 10193 4902 1731633
Chest pain 77.52 31.19 97 10149 19817 1716718
Thrombocytopenia 77.19 31.19 100 10146 21149 1715386
Weight decreased 76.37 31.19 103 10143 22650 1713885
Incorrect dose administered 75.66 31.19 61 10185 7348 1729187
Contraindicated product administered 75.21 31.19 34 10212 1410 1735125
Hypokalaemia 72.66 31.19 56 10190 6318 1730217
Tendonitis 72.29 31.19 33 10213 1400 1735135
Hepatic failure 72.00 31.19 54 10192 5849 1730686
Poisoning deliberate 71.25 31.19 28 10218 814 1735721
Depressed level of consciousness 70.99 31.19 56 10190 6536 1729999
Tropical infectious disease 70.07 31.19 12 10234 1 1736534
Shock haemorrhagic 69.52 31.19 32 10214 1384 1735151
Lower gastrointestinal haemorrhage 69.13 31.19 30 10216 1127 1735408
Bronchospasm 69.07 31.19 36 10210 2046 1734489
Superinfection 68.53 31.19 21 10225 282 1736253
Eosinophilia 68.51 31.19 43 10203 3484 1733051
Drug eruption 67.95 31.19 40 10206 2886 1733649
Confusional state 67.88 31.19 94 10152 21184 1715351
Cellulitis 67.62 31.19 54 10192 6414 1730121
Pain in extremity 67.17 31.19 87 10159 18385 1718150
Peritonsillar abscess 66.95 31.19 17 10229 107 1736428
Abdominal discomfort 66.82 31.19 62 10184 9019 1727516
Lethargy 66.76 31.19 56 10190 7128 1729407
Liver injury 66.63 31.19 34 10212 1848 1734687
Hypercalcaemia 66.57 31.19 34 10212 1852 1734683
Intentional self-injury 65.94 31.19 38 10208 2635 1733900
Rhinitis 65.38 31.19 25 10221 674 1735861
Tonsillitis 65.18 31.19 23 10223 491 1736044
Periorbital oedema 64.20 31.19 25 10221 709 1735826
Erosive duodenitis 63.96 31.19 19 10227 228 1736307
Ureteric obstruction 63.51 31.19 19 10227 234 1736301
Haematocrit decreased 63.33 31.19 44 10202 4229 1732306
Back pain 63.16 31.19 80 10166 16533 1720002
Insomnia 62.87 31.19 79 10167 16197 1720338
Lactic acidosis 62.73 31.19 47 10199 5082 1731453
Pancreatitis acute 62.73 31.19 43 10203 4044 1732491
Hiatus hernia 62.63 31.19 27 10219 998 1735537
Decreased appetite 62.41 31.19 96 10150 23775 1712760
Abdominal pain lower 61.53 31.19 28 10218 1179 1735356
Fatigue 61.40 31.19 147 10099 50634 1685901
Death 60.67 31.19 207 10039 87236 1649299
Nephropathy toxic 60.48 31.19 31 10215 1701 1734834
Eye disorder 60.40 31.19 30 10216 1539 1734996
Rash macular 60.25 31.19 32 10214 1890 1734645
Multiple organ dysfunction syndrome 60.21 31.19 59 10187 9183 1727352
Polyuria 59.34 31.19 28 10218 1282 1735253
Palpitations 58.98 31.19 51 10195 6763 1729772
Respiratory failure 58.57 31.19 72 10174 14433 1722102
Oedema 58.12 31.19 51 10195 6897 1729638
Arthralgia 58.11 31.19 92 10154 23352 1713183
Drug intolerance 57.87 31.19 48 10198 6014 1730521
Inappropriate antidiuretic hormone secretion 57.34 31.19 30 10216 1718 1734817
Alcohol use 57.24 31.19 24 10222 827 1735708
Circulatory collapse 56.84 31.19 38 10208 3429 1733106
Shock 55.09 31.19 40 10206 4121 1732414
Obstruction gastric 54.71 31.19 16 10230 181 1736354
Mallory-Weiss syndrome 54.28 31.19 18 10228 316 1736219
Dermatomyositis 53.99 31.19 17 10229 251 1736284
Haemoptysis 53.74 31.19 42 10204 4834 1731701
Vanishing bile duct syndrome 53.51 31.19 15 10231 144 1736391
Oesophageal ulcer 53.16 31.19 21 10225 619 1735916
International normalised ratio increased 52.23 31.19 52 10194 8247 1728288
Liver function test abnormal 51.88 31.19 44 10202 5682 1730853
Mental status changes 51.63 31.19 45 10201 6030 1730505
Blood loss anaemia 51.57 31.19 23 10223 923 1735612
Septic shock 51.39 31.19 51 10195 8058 1728477
Myalgia 51.15 31.19 70 10176 15588 1720947
Onychomycosis 51.03 31.19 17 10229 303 1736232
Necrotising colitis 50.52 31.19 16 10230 241 1736294
Anaphylactic shock 50.49 31.19 33 10213 2866 1733669
Rhinorrhoea 50.37 31.19 37 10209 3880 1732655
Gastric perforation 50.33 31.19 18 10228 400 1736135
Inflammation 49.89 31.19 35 10211 3415 1733120
Retching 49.84 31.19 24 10222 1150 1735385
Kounis syndrome 49.55 31.19 18 10228 419 1736116
Heart rate increased 48.95 31.19 45 10201 6465 1730070
Musculoskeletal stiffness 48.88 31.19 43 10203 5833 1730702
C-reactive protein increased 48.82 31.19 43 10203 5842 1730693
Mast cell activation syndrome 48.68 31.19 9 10237 6 1736529
Oedema peripheral 48.51 31.19 68 10178 15482 1721053
Conjunctival hyperaemia 48.45 31.19 19 10227 549 1735986
Prothrombin time prolonged 48.03 31.19 26 10220 1595 1734940
Macrophages increased 47.04 31.19 9 10237 9 1736526
Alcohol poisoning 46.77 31.19 18 10228 494 1736041
Dyspepsia 46.59 31.19 39 10207 4946 1731589
Gastrointestinal ulcer 46.59 31.19 16 10230 314 1736221
Lip erosion 46.08 31.19 13 10233 128 1736407
Paraesthesia oral 46.06 31.19 20 10226 752 1735783
Oral pruritus 45.67 31.19 12 10234 88 1736447
Alveolitis 45.49 31.19 16 10230 338 1736197
Streptococcal infection 44.98 31.19 19 10227 667 1735868
Occult blood positive 44.89 31.19 18 10228 552 1735983
Hypophagia 44.89 31.19 33 10213 3464 1733071
Dermo-hypodermitis 44.81 31.19 11 10235 59 1736476
Nasal obstruction 44.43 31.19 12 10234 99 1736436
Treatment failure 44.41 31.19 36 10210 4365 1732170
Hepatitis cholestatic 44.26 31.19 23 10223 1298 1735237
Paraesthesia 43.99 31.19 53 10193 10398 1726137
Hypoaldosteronism 43.96 31.19 10 10236 36 1736499
Proteinuria 43.82 31.19 30 10216 2814 1733721
Oropharyngeal pain 43.60 31.19 37 10209 4781 1731754
Pupils unequal 43.54 31.19 14 10232 222 1736313
Cholestasis 43.51 31.19 33 10213 3632 1732903
Peptic ulcer perforation 43.13 31.19 10 10236 40 1736495
Presyncope 42.85 31.19 29 10217 2669 1733866
Hypertensive emergency 42.12 31.19 13 10233 179 1736356
Psoriatic arthropathy 42.03 31.19 27 10219 2276 1734259
Disorientation 41.49 31.19 38 10208 5431 1731104
Flank pain 41.21 31.19 20 10226 975 1735560
Sepsis 41.04 31.19 71 10175 19367 1717168
Gastritis bacterial 40.99 31.19 10 10236 52 1736483
Vision blurred 40.94 31.19 46 10200 8377 1728158
Thrombotic thrombocytopenic purpura 40.91 31.19 18 10228 699 1735836
Atrial septal defect 40.85 31.19 22 10224 1336 1735199
Chronic kidney disease 40.81 31.19 34 10212 4283 1732252
Cold sweat 40.63 31.19 24 10222 1742 1734793
Pseudomonal sepsis 40.47 31.19 15 10231 370 1736165
Renal disorder 40.34 31.19 33 10213 4053 1732482
Gastrointestinal injury 40.18 31.19 11 10235 96 1736439
Laryngeal oedema 40.11 31.19 19 10227 877 1735658
Coagulopathy 39.71 31.19 28 10218 2753 1733782
Blood ethanol increased 39.65 31.19 10 10236 61 1736474
Bradycardia 38.86 31.19 50 10196 10484 1726051
Fall 38.59 31.19 84 10162 27130 1709405
Foetal exposure during pregnancy 38.45 31.19 39 10207 6320 1730215
Pleural effusion 38.29 31.19 51 10195 11059 1725476
Hepatocellular injury 38.15 31.19 29 10217 3202 1733333
Therapeutic product cross-reactivity 38.15 31.19 13 10233 249 1736286
Abdominal distension 38.02 31.19 39 10207 6405 1730130
Petechiae 37.67 31.19 22 10224 1563 1734972
Pulmonary congestion 37.56 31.19 23 10223 1782 1734753
Dry mouth 37.37 31.19 31 10215 3882 1732653
Sinus tachycardia 37.34 31.19 26 10220 2506 1734029
Irritability 37.29 31.19 36 10210 5496 1731039
Gastrointestinal necrosis 36.71 31.19 16 10230 607 1735928
Ataxia 36.67 31.19 25 10221 2328 1734207
Gastrointestinal hypermotility 36.39 31.19 9 10237 50 1736485
Staphylococcal infection 36.28 31.19 33 10213 4674 1731861
Pulmonary haemorrhage 36.25 31.19 22 10224 1677 1734858
Dialysis 36.19 31.19 25 10221 2379 1734156
Blister 36.16 31.19 31 10215 4061 1732474
Metabolic alkalosis 35.60 31.19 12 10234 222 1736313
Wrong product administered 35.48 31.19 19 10227 1140 1735395
Purpura 35.38 31.19 22 10224 1752 1734783
Ulcer haemorrhage 35.17 31.19 14 10232 421 1736114
Renal tubular acidosis 35.10 31.19 13 10233 320 1736215
Blood lactate dehydrogenase increased 34.85 31.19 29 10217 3646 1732889
Implant site extravasation 34.59 31.19 11 10235 168 1736367
Cardiomegaly 34.49 31.19 24 10222 2310 1734225
Large intestinal ulcer 34.33 31.19 13 10233 341 1736194
Haemodialysis 34.28 31.19 25 10221 2591 1733944
Toxic skin eruption 34.17 31.19 22 10224 1861 1734674
Empyema 34.01 31.19 14 10232 460 1736075
Miosis 33.77 31.19 20 10226 1458 1735077
Respiratory distress 33.71 31.19 33 10213 5124 1731411
Ocular icterus 33.70 31.19 15 10231 599 1735936
Hepatic enzyme increased 33.62 31.19 37 10209 6584 1729951
Seizure 33.53 31.19 67 10179 20374 1716161
Electrocardiogram QT prolonged 33.51 31.19 34 10212 5511 1731024
Chills 33.34 31.19 49 10197 11638 1724897
Borderline personality disorder 33.22 31.19 8 10238 39 1736496
Oral mucosa erosion 32.91 31.19 11 10235 198 1736337
Necrotising fasciitis 32.90 31.19 15 10231 634 1735901
Labelled drug-drug interaction medication error 32.76 31.19 19 10227 1332 1735203
Hepatotoxicity 32.76 31.19 26 10220 3058 1733477
Swollen tongue 32.70 31.19 25 10221 2783 1733752
Infection 32.66 31.19 50 10196 12310 1724225
Oesophageal rupture 32.65 31.19 10 10236 134 1736401
Pallor 32.52 31.19 27 10219 3384 1733151
Cerebral atrophy congenital 32.45 31.19 6 10240 4 1736531
Duodenal stenosis 32.43 31.19 9 10237 83 1736452
Muscular weakness 32.21 31.19 45 10201 10204 1726331
Gastrointestinal disorder 32.20 31.19 31 10215 4717 1731818
Mycoplasma infection 32.14 31.19 9 10237 86 1736449
Colonic abscess 31.96 31.19 9 10237 88 1736447
Swelling 31.95 31.19 37 10209 6959 1729576
Angular cheilitis 31.83 31.19 8 10238 48 1736487
Dermatitis bullous 31.79 31.19 18 10228 1206 1735329
Electrocardiogram QT shortened 31.69 31.19 8 10238 49 1736486
Sudden death 31.68 31.19 25 10221 2915 1733620
Nephritis 31.50 31.19 13 10233 430 1736105
Urine output decreased 31.40 31.19 19 10227 1441 1735094
Joint swelling 31.39 31.19 35 10211 6318 1730217
Brain empyema 31.36 31.19 6 10240 6 1736529
Kawasaki's disease 31.28 31.19 8 10238 52 1736483

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 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
FDA Chemical/Ingredient N0000175721 Nonsteroidal Anti-inflammatory Compounds

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
Juvenile rheumatoid arthritis indication 410795001
Acute postoperative pain indication 107401000119105
Necrotizing enterocolitis in fetus OR newborn contraindication 2707005
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:557
Acute abdominal pain contraindication 116290004
Gastrointestinal obstruction contraindication 126765001
Neoplasm of brain contraindication 126952004 DOID:1319
Seizure disorder contraindication 128613002
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
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
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
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 CLINICALLY 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 CLINICALLY 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 GLAXOSMITHKLINE 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 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 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/200ML (4MG/ML) CALDOLOR CUMBERLAND PHARMS N022348 Jan. 25, 2019 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/200ML (4MG/ML) CALDOLOR CUMBERLAND PHARMS N022348 Jan. 25, 2019 RX SOLUTION INTRAVENOUS 8871810 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 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 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 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/200ML (4MG/ML) CALDOLOR CUMBERLAND PHARMS N022348 Jan. 25, 2019 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
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
800MG/200ML (4MG/ML) CALDOLOR CUMBERLAND PHARMS N022348 Jan. 25, 2019 RX SOLUTION INTRAVENOUS 9072661 March 16, 2032 METHODS OF TREATING PAIN, INFLAMMATION, FEVER, PATENT DUCTUS ARTERIOSIS WITH AQUEOUS COMPOSITION
800MG/200ML (4MG/ML) CALDOLOR CUMBERLAND PHARMS N022348 Jan. 25, 2019 RX SOLUTION INTRAVENOUS 9072710 March 16, 2032 METHODS OF MAKING AQUEOUS COMPOSITION AND TREATING PAIN, INFLAMMATION, FEVER, PATENT DUCTUS ARTERIOSIS WITH AQUEOUS COMPOSITION

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
125MG ADVIL DUAL ACTION WITH ACETAMINOPHEN PFIZER INC N211733 Feb. 28, 2020 OTC TABLET ORAL Feb. 28, 2023 NEW PRODUCT

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
D007052 MESH_DESCRIPTOR_UI
4032936 VUID
N0000189536 NUI
C0074814 UMLSCUI
D00126 KEGG_DRUG
38268001 SNOMEDCT_US
2133 MMSL
5640 RXNORM
387207008 SNOMEDCT_US
4862 MMSL
d00015 MMSL
7027 MMSL
4017840 VANDF
002377 NDDF
3672 PUBCHEM_CID
CHEBI:132922 CHEBI
CHEMBL521 ChEMBL_ID
CHEMBL175 ChEMBL_ID
CHEMBL427526 ChEMBL_ID
C016106 MESH_SUPPLEMENTAL_RECORD_UI
DB01050 DRUGBANK_ID
N01ORX9D6S UNII
57469-77-9 SECONDARY_CAS_RN
IBP PDB_CHEM_ID
2118 INN_ID
CHEMBL1201141 ChEMBL_ID
CHEMBL1241153 ChEMBL_ID
CHEMBL3989408 ChEMBL_ID
2713 IUPHAR_LIGAND_ID

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
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, FILM 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
basic care childrens ibuprofen HUMAN OTC DRUG LABEL 1 0113-1461 TABLET, CHEWABLE 100 mg ORAL ANDA 9 sections
Good Sense Childrens Ibuprofen HUMAN OTC DRUG LABEL 1 0113-2461 TABLET, CHEWABLE 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 0113-7517 TABLET, FILM COATED 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 0113-7660 SUSPENSION 100 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
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 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
ibuprofen HUMAN OTC DRUG LABEL 1 0363-0166 SUSPENSION 100 mg ORAL ANDA 9 sections
Ibuprofen HUMAN OTC DRUG LABEL 1 0363-0197 CAPSULE, LIQUID FILLED 200 mg ORAL ANDA 10 sections