meloxicam 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
anti-inflammatory, isoxicam derivatives 1676 71125-38-7

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • reumoxicam
  • miloxicam
  • meloxicam
  • metacam
  • meloxicam sodium
  • meloxicam sodium hydrate
Meloxicam is a nonsteroidal anti-inflammatory drug (NSAID) that exhibits anti-inflammatory, analgesic, and antipyretic activities in animal models. The mechanism of action of meloxicam, like that of other NSAIDs, may be related to prostaglandin synthetase (cyclo-oxygenase) inhibition.
  • Molecular weight: 351.40
  • Formula: C14H13N3O4S2
  • CLOGP: 2.44
  • LIPINSKI: 0
  • HAC: 7
  • HDO: 2
  • TPSA: 99.60
  • ALOGS: -3.36
  • ROTB: 2
  • Status: OFP
    • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
15 mg O
15 mg P
15 mg R

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 2 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 0.01 mg/mL Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 0.20 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 0.71 µM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 97 % 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) 0.12 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.00 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 18 hours Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
April 13, 2000 FDA BOEHRINGER INGELHEIM

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
Rheumatoid arthritis 231.49 9.92 806 84046 201744 50318528
Spinal column injury 162.53 9.92 73 84779 1729 50518543
Synovial cyst 154.24 9.92 120 84732 8046 50512226
Surgical failure 150.25 9.92 57 84795 864 50519408
Psoriatic arthropathy 143.85 9.92 272 84580 46760 50473512
Bronchitis chronic 140.05 9.92 85 84767 3792 50516480
Ankylosing spondylitis 139.05 9.92 107 84745 7058 50513214
Psoriasis 122.52 9.92 321 84531 68679 50451593
Maternal exposure during pregnancy 119.89 9.92 59 84793 159719 50360553
Pemphigus 116.45 9.92 29 84823 120137 50400135
Accident 115.90 9.92 84 84768 5057 50515215
Fibromyalgia 106.52 9.92 234 84618 44744 50475528
Exposure during pregnancy 103.11 9.92 37 84815 120978 50399294
Death 101 9.92 250 84602 325129 50195143
Neck pain 92.76 9.92 257 84595 56810 50463462
Glossodynia 87.70 9.92 42 84810 115527 50404745
Arthralgia 86.90 9.92 1119 83733 437583 50082689
Visual impairment 86.87 9.92 282 84570 67993 50452279
Musculoskeletal stiffness 86.39 9.92 435 84417 128046 50392226
Tenosynovitis stenosans 86.14 9.92 51 84801 2173 50518099
Febrile neutropenia 81.27 9.92 31 84821 97636 50422636
Neutropenia 81.18 9.92 77 84775 147888 50372384
Synovial fluid analysis 80.81 9.92 44 84808 1594 50518678
Pulmonary toxicity 80.45 9.92 70 84782 5492 50514780
Breast cancer 78.64 9.92 202 84650 42688 50477584
Tenosynovitis 77.31 9.92 92 84760 10473 50509799
Pain in extremity 75.75 9.92 744 84108 272121 50248151
Drug hypersensitivity 75.42 9.92 696 84156 250314 50269958
Musculoskeletal pain 75.20 9.92 279 84573 71898 50448374
Rheumatoid lung 73.85 9.92 48 84804 2417 50517855
Linear IgA disease 71.22 9.92 37 84815 1217 50519055
Joint range of motion decreased 69.33 9.92 117 84735 18395 50501877
Product dose omission issue 65.24 9.92 529 84323 183309 50336963
Neck surgery 64.93 9.92 37 84815 1466 50518806
Dry eye 62.85 9.92 155 84697 31940 50488332
Scleritis 62.20 9.92 48 84804 3179 50517093
Antinuclear antibody positive 62.11 9.92 64 84788 6208 50514064
Bone density decreased 58.38 9.92 82 84770 10993 50509279
Toxicity to various agents 57.79 9.92 174 84678 212325 50307947
Systemic lupus erythematosus 57.33 9.92 92 84760 140530 50379742
Crepitations 57.19 9.92 61 84791 6158 50514114
Hypotension 57.00 9.92 203 84649 235266 50285006
Gait disturbance 55.57 9.92 436 84416 149569 50370703
Reversible airways obstruction 54.80 9.92 29 84823 991 50519281
Drug ineffective 54.03 9.92 1773 83079 817560 49702712
Vital capacity decreased 50.85 9.92 27 84825 929 50519343
Pericarditis 49.24 9.92 36 84816 78653 50441619
Thrombocytopenia 47.94 9.92 88 84764 127585 50392687
General physical health deterioration 46.02 9.92 107 84745 142327 50377945
Sputum culture positive 45.99 9.92 29 84823 1385 50518887
Off label use 44.00 9.92 547 84305 473879 50046393
Bursitis 43.44 9.92 107 84745 22028 50498244
Viral upper respiratory tract infection 43.28 9.92 56 84796 6940 50513332
Impaired work ability 43.06 9.92 80 84772 13560 50506712
Nodule 41.99 9.92 90 84762 16913 50503359
Joint swelling 41.97 9.92 610 84242 244676 50275596
Anti-cyclic citrullinated peptide antibody positive 40.76 9.92 35 84817 70552 50449720
Photophobia 40.51 9.92 82 84770 14805 50505467
Pleuritic pain 40.38 9.92 52 84800 6414 50513858
Bronchial secretion retention 39.39 9.92 27 84825 1486 50518786
Loss of personal independence in daily activities 38.78 9.92 225 84627 69825 50450447
Abortion spontaneous 38.70 9.92 11 84841 41761 50478511
Conjunctivitis 38.21 9.92 84 84768 16061 50504211
Joint effusion 38.18 9.92 74 84778 12947 50507325
Intervertebral disc degeneration 37.65 9.92 75 84777 13386 50506886
Wound 37.03 9.92 76 84776 105718 50414554
Folliculitis 36.95 9.92 10 84842 39215 50481057
Cardiac failure 36.73 9.92 44 84808 75996 50444276
Cushingoid 36.22 9.92 50 84802 6595 50513677
Feeling jittery 35.92 9.92 66 84786 11094 50509178
Muscle injury 35.84 9.92 9 84843 37102 50483170
Malignant neoplasm progression 35.55 9.92 37 84815 68087 50452185
Condition aggravated 35.52 9.92 697 84155 296361 50223911
Septic shock 34.68 9.92 27 84825 57148 50463124
Back pain 34.06 9.92 538 84314 219492 50300780
Pancytopenia 33.27 9.92 56 84796 83974 50436298
Flank pain 33.06 9.92 70 84782 13045 50507227
Listless 32.41 9.92 29 84823 2361 50517911
Drug abuse 31.80 9.92 32 84820 59814 50460458
Injection site swelling 31.31 9.92 146 84706 41627 50478645
Injection site pain 30.84 9.92 303 84549 110721 50409551
Gastric ulcer 30.77 9.92 92 84760 21213 50499059
Allergy to chemicals 30.56 9.92 22 84830 1310 50518962
Tenderness 30.53 9.92 84 84768 18481 50501791
Somatic delusion 30.15 9.92 16 84836 550 50519722
Arthritis 29.87 9.92 248 84604 86473 50433799
Osteoarthritis 29.69 9.92 207 84645 68399 50451873
Peripheral swelling 29.43 9.92 497 84355 205439 50314833
Premature delivery 28.94 9.92 3 84849 23660 50496612
Dry mouth 28.88 9.92 177 84675 56001 50464271
Ocular hyperaemia 28.72 9.92 87 84765 20205 50500067
Pyrexia 27.91 9.92 459 84393 379744 50140528
Disease progression 27.86 9.92 76 84776 95790 50424482
Sleep disorder due to general medical condition, insomnia type 27.83 9.92 9 84843 31438 50488834
Eye irritation 27.64 9.92 77 84775 17063 50503209
Rheumatoid nodule 27.62 9.92 64 84788 12671 50507601
Product use in unapproved indication 27.22 9.92 101 84751 115718 50404554
Malaise 27.00 9.92 745 84107 334787 50185485
Ischaemic gastritis 26.96 9.92 5 84847 0 50520272
Spinal cord infection 26.84 9.92 15 84837 572 50519700
Anaemia 26.47 9.92 283 84569 252173 50268099
Pain 25.28 9.92 1199 83653 577704 49942568
Surgery 25.21 9.92 109 84743 30096 50490176
Hypoaesthesia 25.20 9.92 325 84527 126932 50393340
Injection site erythema 25.12 9.92 213 84639 74723 50445549
Infusion related reaction 24.94 9.92 174 84678 169383 50350889
Hepatic enzyme increased 24.91 9.92 132 84720 137248 50383024
Lymphomatoid papulosis 24.91 9.92 9 84843 118 50520154
Pleural effusion 24.86 9.92 63 84789 81391 50438881
Cholestasis 24.84 9.92 6 84846 25395 50494877
Eye pain 24.78 9.92 104 84748 28345 50491927
Acute kidney injury 23.76 9.92 256 84596 227802 50292470
Pregnancy 23.59 9.92 10 84842 29567 50490705
Depression 23.54 9.92 399 84453 165024 50355248
Pulmonary mass 23.53 9.92 77 84775 18628 50501644
Intentional self-injury 23.52 9.92 5 84847 23107 50497165
Feeling abnormal 23.39 9.92 317 84535 125175 50395097
Gastric ulcer haemorrhage 23.33 9.92 33 84819 4451 50515821
Reduced facial expression 22.93 9.92 20 84832 1574 50518698
Injection site reaction 22.86 9.92 153 84699 49879 50470393
Infection 22.06 9.92 410 84442 172544 50347728
Electrocardiogram QT prolonged 22.03 9.92 33 84819 51853 50468419
Hyponatraemia 21.84 9.92 85 84767 96054 50424218
Intentional overdose 21.78 9.92 45 84807 62459 50457813
Pre-existing condition improved 21.62 9.92 41 84811 7056 50513216
Head discomfort 21.34 9.92 53 84799 10966 50509306
Musculoskeletal discomfort 21.20 9.92 64 84788 14834 50505438
Bradycardia 21.11 9.92 48 84804 64378 50455894
Pulmonary oedema 20.90 9.92 31 84821 48907 50471365
Hypermobility syndrome 20.88 9.92 14 84838 743 50519529
Premature baby 20.77 9.92 3 84849 18334 50501938
Swelling 20.71 9.92 226 84626 200646 50319626
Drug intolerance 20.67 9.92 497 84355 218607 50301665
HLA marker study positive 20.56 9.92 9 84843 200 50520072
Atelectasis 20.17 9.92 72 84780 18198 50502074
Eyelid retraction 19.95 9.92 6 84846 42 50520230
Interstitial lung disease 19.90 9.92 155 84697 53021 50467251
Lower respiratory tract infection 19.86 9.92 87 84765 95114 50425158
Oesophageal mucosal tear 19.81 9.92 5 84847 16 50520256
Upper-airway cough syndrome 19.68 9.92 44 84808 8506 50511766
Fixed eruption 19.58 9.92 14 84838 825 50519447
Poliomyelitis 19.48 9.92 6 84846 46 50520226
Neoplasm malignant 19.35 9.92 85 84767 23630 50496642
Sedation 19.15 9.92 14 84838 30596 50489676
Muscular weakness 18.95 9.92 243 84609 94770 50425502
Vertigo 18.80 9.92 150 84702 51682 50468590
Multiple organ dysfunction syndrome 18.61 9.92 35 84817 50302 50469970
Carpal tunnel syndrome 18.16 9.92 66 84786 16827 50503445
Gastric mucosal hypertrophy 18.07 9.92 6 84846 60 50520212
Small intestinal ulcer haemorrhage 17.89 9.92 6 84846 62 50520210
Foetal exposure during pregnancy 17.79 9.92 12 84840 27347 50492925
Cataract 17.77 9.92 138 84714 47162 50473110
Stress fracture 17.68 9.92 37 84815 6838 50513434
Spinal operation 17.65 9.92 35 84817 6225 50514047
Product use issue 17.55 9.92 163 84689 149312 50370960
Nodular rash 17.52 9.92 8 84844 197 50520075
Respiratory failure 17.43 9.92 86 84766 91095 50429177
Hepatocellular injury 17.39 9.92 11 84841 25936 50494336
Drug interaction 17.37 9.92 233 84619 199388 50320884
Loss of consciousness 16.82 9.92 257 84595 104096 50416176
Therapy cessation 16.70 9.92 87 84765 25924 50494348
Mucosal inflammation 16.59 9.92 26 84826 40116 50480156
Breast cancer female 16.57 9.92 36 84816 6826 50513446
Rash pruritic 16.56 9.92 137 84715 47709 50472563
Injection site bruising 16.53 9.92 112 84740 36656 50483616
Pharyngeal paraesthesia 16.40 9.92 16 84836 1453 50518819
Nephrolithiasis 16.40 9.92 107 84745 34586 50485686
Injection site vesicles 16.34 9.92 21 84831 2584 50517688
Urine odour abnormal 16.32 9.92 31 84821 5342 50514930
Parotid gland enlargement 16.26 9.92 12 84840 743 50519529
Sciatica 16.22 9.92 75 84777 21307 50498965
Dyspnoea 16.21 9.92 752 84100 546856 49973416
Affect lability 16.09 9.92 42 84810 8956 50511316
Pulmonary arterial hypertension 16.00 9.92 7 84845 20312 50499960
Tinnitus 15.98 9.92 91 84761 28041 50492231
Agranulocytosis 15.91 9.92 8 84844 21413 50498859
Gastrointestinal disorder 15.89 9.92 93 84759 94363 50425909
Foreign body 15.82 9.92 18 84834 1953 50518319
Leukopenia 15.79 9.92 59 84793 67469 50452803
Device expulsion 15.79 9.92 15 84837 28807 50491465
Multiple allergies 15.65 9.92 40 84812 8423 50511849
Respiratory distress 15.41 9.92 17 84835 30472 50489800
Eosinophilia 15.37 9.92 6 84846 18646 50501626
Neutrophil count decreased 15.32 9.92 34 84818 45992 50474280
Body temperature increased 15.27 9.92 18 84834 31323 50488949
Distributive shock 15.12 9.92 12 84840 828 50519444
Hepatotoxicity 15.11 9.92 14 84838 27212 50493060
Dysphoria 15.07 9.92 28 84824 4746 50515526
Mobility decreased 14.91 9.92 202 84650 79746 50440526
Sacroiliitis 14.85 9.92 20 84832 2577 50517695
Anhidrosis 14.82 9.92 6 84846 109 50520163
Swelling face 14.82 9.92 144 84708 52451 50467821
Contraindicated product administered 14.79 9.92 169 84683 148789 50371483
Road traffic accident 14.65 9.92 80 84772 24272 50496000
Duodenal ulcer 14.64 9.92 34 84818 6741 50513531
Neutropenic sepsis 14.52 9.92 3 84849 14144 50506128
Platelet count decreased 14.49 9.92 104 84748 100622 50419650
Bone marrow failure 14.41 9.92 15 84837 27609 50492663
Intervertebral disc protrusion 14.35 9.92 70 84782 20323 50499949
Kyphoscoliosis 14.05 9.92 9 84843 442 50519830
Ulcer 13.98 9.92 69 84783 20131 50500141
Finger deformity 13.94 9.92 30 84822 5652 50514620
Acute myeloid leukaemia 13.90 9.92 4 84848 15070 50505202
Blood creatinine increased 13.90 9.92 73 84779 76087 50444185
Tachycardia 13.87 9.92 104 84748 99659 50420613
Small intestine ulcer 13.77 9.92 8 84844 329 50519943
Coma 13.75 9.92 49 84803 56830 50463442
Posterior reversible encephalopathy syndrome 13.70 9.92 4 84848 14924 50505348
Ejection fraction decreased 13.63 9.92 7 84845 18513 50501759
Suicide attempt 13.58 9.92 43 84809 51689 50468583
Tubulointerstitial nephritis 13.55 9.92 56 84796 15155 50505117
Haemorrhagic diathesis 13.53 9.92 24 84828 3924 50516348
Spinal osteoarthritis 13.45 9.92 53 84799 14039 50506233
Myofascial pain syndrome 13.40 9.92 17 84835 2066 50518206
Lip swelling 13.39 9.92 79 84773 24657 50495615
Jaundice neonatal 13.36 9.92 11 84841 800 50519472
Asterixis 13.35 9.92 13 84839 1178 50519094
Anxiety 13.32 9.92 391 84461 177215 50343057
Chromaturia 13.23 9.92 54 84798 14536 50505736
Thalassaemia minor 13.18 9.92 4 84848 29 50520243
Meralgia paraesthetica 13.17 9.92 6 84846 147 50520125
Limb asymmetry 13.16 9.92 11 84841 817 50519455
Injection site warmth 13.11 9.92 52 84800 13814 50506458
Hypercalcaemia 12.97 9.92 12 84840 23340 50496932
Trigger finger 12.95 9.92 23 84829 3765 50516507
Cytomegalovirus infection 12.91 9.92 7 84845 17955 50502317
Pneumonia aspiration 12.89 9.92 20 84832 30984 50489288
Urticaria 12.86 9.92 147 84705 129414 50390858
Purpura senile 12.74 9.92 9 84843 520 50519752
Intentional product misuse 12.70 9.92 127 84725 46607 50473665
International normalised ratio increased 12.69 9.92 34 84818 43118 50477154
Lumbar spinal stenosis 12.66 9.92 24 84828 4130 50516142
Clostridium difficile colitis 12.62 9.92 7 84845 17735 50502537
Dysstasia 12.42 9.92 61 84791 17758 50502514
Hepatic cirrhosis 12.41 9.92 7 84845 17570 50502702
Hypoxia 12.39 9.92 44 84808 51079 50469193
Hepatic failure 12.33 9.92 22 84830 32261 50488011
Therapy non-responder 12.31 9.92 44 84808 50978 50469294
Focal segmental glomerulosclerosis 12.06 9.92 13 84839 1328 50518944
Atopic keratoconjunctivitis 12.03 9.92 3 84849 9 50520263
Duodenal ulcer perforation 11.91 9.92 38 84814 45573 50474699
Joint stiffness 11.70 9.92 89 84763 30219 50490053
Pelvic fracture 11.54 9.92 44 84808 11476 50508796
Sputum culture 11.35 9.92 5 84847 113 50520159
Pelvic adhesions 11.32 9.92 7 84845 323 50519949
Influenza 11.31 9.92 212 84640 89326 50430946
Crystal nephropathy 11.27 9.92 10 84842 805 50519467
Resorption bone increased 11.27 9.92 11 84841 1000 50519272
Helicobacter infection 11.24 9.92 44 84808 49658 50470614
Confusional state 11.24 9.92 232 84620 185696 50334576
General symptom 11.19 9.92 17 84835 2446 50517826
Prescription drug used without a prescription 11.13 9.92 14 84838 1686 50518586
Grip strength decreased 11.10 9.92 45 84807 12076 50508196
Aerophagia 11.00 9.92 3 84849 14 50520258
Small intestinal stenosis 10.94 9.92 8 84844 488 50519784
Antinuclear antibody 10.80 9.92 8 84844 498 50519774
Manipulation 10.70 9.92 4 84848 58 50520214
Therapy interrupted 10.67 9.92 64 84788 20088 50500184
Cholecystectomy 10.56 9.92 37 84815 9266 50511006
Injury 10.55 9.92 127 84725 48798 50471474
Lacrimation decreased 10.53 9.92 7 84845 366 50519906
Wrong drug 10.53 9.92 5 84847 135 50520137
Memory impairment 10.41 9.92 189 84663 79171 50441101
Tarsal tunnel syndrome 10.35 9.92 8 84844 531 50519741
Somnolence 10.23 9.92 336 84516 154649 50365623
Hand deformity 10.21 9.92 113 84739 100086 50420186
Neuroleptic malignant syndrome 10.18 9.92 3 84849 11127 50509145
Foot fracture 10.13 9.92 63 84789 20028 50500244
Myelosuppression 10.11 9.92 5 84847 13512 50506760
Knee operation 10.03 9.92 24 84828 4849 50515423
Hyperkalaemia 9.99 9.92 44 84808 48045 50472227
Generalised tonic-clonic seizure 9.98 9.92 18 84834 26292 50493980
Spinal cord herniation 9.98 9.92 3 84849 21 50520251
Eosinophil count increased 9.92 9.92 35 84817 8795 50511477

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
Psoriasis 184.29 11.87 182 25990 32045 29516310
Psoriatic arthropathy 101.14 11.87 92 26080 14599 29533756
Gastric haemorrhage 77.64 11.87 65 26107 9232 29539123
Arthralgia 76.42 11.87 284 25888 139333 29409022
Joint swelling 64.08 11.87 138 26034 49492 29498863
Lipoma 53.85 11.87 26 26146 1405 29546950
Pain 49.97 11.87 290 25882 171142 29377213
Duodenal ulcer 45.17 11.87 48 26124 9190 29539165
Ankylosing spondylitis 45.17 11.87 34 26138 4142 29544213
Intestinal diaphragm disease 44.35 11.87 14 26158 235 29548120
Seronegative arthritis 41.59 11.87 19 26153 905 29547450
Neutropenia 39.58 11.87 35 26137 131676 29416679
Off label use 37.19 11.87 139 26033 300661 29247694
Osteoarthritis 36.62 11.87 61 26111 18042 29530313
Xyphoid retraction 36.18 11.87 11 26161 162 29548193
Febrile neutropenia 35.97 11.87 28 26144 112212 29436143
Musculoskeletal stiffness 35.13 11.87 92 26080 37366 29510989
Back pain 35.10 11.87 181 25991 102103 29446252
Gastrointestinal haemorrhage 34.01 11.87 150 26022 79383 29468972
Gastric ulcer 33.42 11.87 51 26121 14010 29534345
Pain in extremity 32.88 11.87 188 25984 110245 29438110
Product dose omission issue 29.96 11.87 166 26006 96217 29452138
Thrombocytopenia 28.63 11.87 47 26125 134776 29413579
Surgery 28.38 11.87 43 26129 11736 29536619
Oesophageal infection 27.30 11.87 10 26162 268 29548087
Arthropathy 26.73 11.87 59 26113 21495 29526860
Rheumatoid arthritis 26.19 11.87 75 26097 32077 29516278
Exostosis 25.72 11.87 23 26149 3566 29544789
Arthritis 24.01 11.87 62 26110 24957 29523398
Drug ineffective 23.87 11.87 452 25720 362718 29185637
General physical health deterioration 23.60 11.87 34 26138 102823 29445532
Inflammatory marker increased 23.36 11.87 22 26150 3645 29544710
Oropharyngeal pain 22.59 11.87 67 26105 29218 29519137
Injection site erythema 21.77 11.87 42 26130 13914 29534441
Arthrofibrosis 21.09 11.87 6 26166 69 29548286
Epstein Barr virus positive mucocutaneous ulcer 19.72 11.87 8 26164 284 29548071
Finger deformity 18.72 11.87 12 26160 1128 29547227
Multiple organ dysfunction syndrome 18.66 11.87 17 26155 63099 29485256
Cartilage injury 18.30 11.87 9 26163 506 29547849
Duodenal ulcer haemorrhage 17.98 11.87 21 26151 4458 29543897
Drug hypersensitivity 17.50 11.87 112 26060 68294 29480061
Hip arthroplasty 17.44 11.87 19 26153 3739 29544616
Leukopenia 17.38 11.87 14 26158 55189 29493166
Acute generalised exanthematous pustulosis 17.32 11.87 23 26149 5560 29542795
Sinusitis 17.17 11.87 68 26104 34282 29514073
Musculoskeletal discomfort 16.50 11.87 24 26148 6317 29542038
Foot fracture 16.49 11.87 19 26153 3976 29544379
Foot deformity 16.41 11.87 19 26153 3996 29544359
Uveitis 16.19 11.87 23 26149 5924 29542431
Macrophages increased 16.10 11.87 6 26166 169 29548186
Electrocardiogram QRS complex prolonged 16.05 11.87 19 26153 4091 29544264
Fixed eruption 15.76 11.87 11 26161 1191 29547164
Cellulitis gangrenous 15.53 11.87 6 26166 187 29548168
Hypokalaemia 15.47 11.87 13 26159 50190 29498165
Skin ulcer 15.39 11.87 44 26128 18796 29529559
Joint stiffness 15.38 11.87 29 26143 9444 29538911
Iritis 15.31 11.87 11 26161 1247 29547108
Ascites 14.69 11.87 7 26165 36612 29511743
Injection site bruising 14.60 11.87 25 26147 7555 29540800
Loose body in joint 14.31 11.87 4 26168 43 29548312
Sleep apnoea syndrome 14.27 11.87 41 26131 17558 29530797
Product physical issue 14.21 11.87 13 26159 2075 29546280
Acanthosis 14.17 11.87 5 26167 120 29548235
Tendon disorder 14.15 11.87 14 26158 2464 29545891
Water intoxication 14.10 11.87 7 26165 402 29547953
Hernia 14.09 11.87 26 26146 8332 29540023
Skin exfoliation 13.98 11.87 48 26124 22597 29525758
Fatigue 13.73 11.87 372 25800 316449 29231906
Knee arthroplasty 13.70 11.87 21 26151 5788 29542567
Duodenal ulcer perforation 13.55 11.87 11 26161 1495 29546860
Intervertebral disc protrusion 13.41 11.87 26 26146 8644 29539711
Headache 13.29 11.87 222 25950 173785 29374570
Synovial cyst 13.28 11.87 12 26160 1885 29546470
Grip strength decreased 13.11 11.87 13 26159 2294 29546061
Prostatic specific antigen increased 12.96 11.87 32 26140 12532 29535823
Eyelid margin crusting 12.78 11.87 5 26167 161 29548194
Lumbar radiculopathy 12.67 11.87 8 26164 733 29547622
Pyrexia 12.63 11.87 179 25993 287443 29260912
Feeling abnormal 12.62 11.87 87 26085 54358 29493997
Pulmonary tuberculosis 12.21 11.87 17 26155 4298 29544057
Depression 12.18 11.87 122 26050 85025 29463330
Peptic ulcer perforation 12.11 11.87 5 26167 186 29548169
Neck surgery 12.05 11.87 6 26166 347 29548008
Gastrointestinal injury 12.03 11.87 6 26166 348 29548007
Peripheral swelling 12.03 11.87 97 26075 63642 29484713
Joint space narrowing 12.02 11.87 4 26168 80 29548275
Neck pain 11.99 11.87 44 26128 21403 29526952
International normalised ratio increased 11.91 11.87 13 26159 44359 29503996
Back disorder 11.90 11.87 20 26152 5953 29542402

FDA Adverse Event Reporting System (Geriatric)

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
Rheumatoid arthritis 228.90 10.40 595 83287 163699 64251151
Psoriasis 202.60 10.40 347 83535 71356 64343494
Psoriatic arthropathy 200.55 10.40 264 83618 43017 64371833
Arthralgia 161.55 10.40 1055 82827 441205 63973645
Surgical failure 160.39 10.40 54 83828 745 64414105
Synovial cyst 156.45 10.40 107 83775 7600 64407250
Neutropenia 128.72 10.40 76 83806 239548 64175302
Ankylosing spondylitis 127.51 10.40 97 83785 8137 64406713
Fibromyalgia 124.16 10.40 190 83692 35541 64379309
Joint swelling 122.80 10.40 580 83302 214802 64200048
Musculoskeletal stiffness 117.46 10.40 390 83492 122816 64292034
Febrile neutropenia 113.43 10.40 51 83831 187606 64227244
Drug hypersensitivity 112.78 10.40 608 83274 237207 64177643
Pain in extremity 109.19 10.40 721 83161 302364 64112486
Pain 104.09 10.40 1138 82744 552373 63862477
Spinal column injury 104.07 10.40 50 83832 1802 64413048
Bronchitis chronic 100.34 10.40 63 83819 3869 64410981
Tenosynovitis stenosans 95.47 10.40 48 83834 1912 64412938
Thrombocytopenia 88.81 10.40 96 83786 223705 64191145
Synovial fluid analysis 87.08 10.40 42 83840 1527 64413323
Neck pain 81.62 10.40 219 83663 61314 64353536
Rheumatoid lung 79.50 10.40 46 83836 2433 64412417
Death 79.15 10.40 341 83541 482364 63932486
Musculoskeletal pain 78.03 10.40 258 83624 81036 64333814
Accident 75.14 10.40 66 83816 6780 64408070
Neck surgery 73.86 10.40 37 83845 1462 64413388
Product dose omission issue 72.29 10.40 467 83415 194280 64220570
Scleritis 71.89 10.40 46 83836 2920 64411930
Joint range of motion decreased 71.66 10.40 106 83776 19237 64395613
Hypotension 68.80 10.40 259 83623 380715 64034135
Dry eye 68.58 10.40 130 83752 28889 64385961
Drug ineffective 62.30 10.40 1479 82403 838768 63576082
Bursitis 61.98 10.40 105 83777 21380 64393470
Back pain 60.25 10.40 542 83340 249629 64165221
Visual impairment 59.76 10.40 222 83660 73855 64340995
Off label use 59.38 10.40 532 83350 632274 63782576
Bone density decreased 57.77 10.40 68 83814 9884 64404966
General physical health deterioration 56.32 10.40 113 83769 204312 64210538
Septic shock 55.77 10.40 34 83848 105403 64309447
Reversible airways obstruction 52.89 10.40 27 83855 1111 64413739
Linear IgA disease 52.75 10.40 37 83845 2737 64412113
Peripheral swelling 51.29 10.40 455 83427 208698 64206152
Osteoarthritis 51.24 10.40 190 83692 63146 64351704
Injection site erythema 51.23 10.40 205 83677 70595 64344255
Pulmonary toxicity 50.53 10.40 59 83823 8502 64406348
Vital capacity decreased 48.56 10.40 25 83857 1047 64413803
Pancytopenia 47.91 10.40 70 83812 143239 64271611
Acute kidney injury 47.83 10.40 365 83517 448875 63965975
Antinuclear antibody positive 47.17 10.40 49 83833 6201 64408649
Multiple organ dysfunction syndrome 46.66 10.40 38 83844 101375 64313475
Toxicity to various agents 46.32 10.40 280 83602 363233 64051617
Impaired work ability 46.06 10.40 76 83806 15143 64399707
Joint effusion 45.88 10.40 71 83811 13402 64401448
Nodule 45.66 10.40 83 83799 17864 64396986
Intestinal diaphragm disease 45.00 10.40 17 83865 333 64414517
Gastric ulcer 44.59 10.40 112 83770 30122 64384728
Duodenal ulcer 43.58 10.40 72 83810 14363 64400487
Arthritis 43.57 10.40 220 83662 83594 64331256
Feeling jittery 43.37 10.40 61 83821 10574 64404276
Feeling abnormal 43.34 10.40 310 83572 133292 64281558
Gastric haemorrhage 43.08 10.40 69 83813 13412 64401438
Injection site swelling 43.07 10.40 135 83747 41218 64373632
Tenosynovitis 42.62 10.40 64 83818 11769 64403081
Anaemia 41.55 10.40 305 83577 378375 64036475
Photophobia 41.51 10.40 78 83804 17215 64397635
Pyrexia 41.14 10.40 497 83385 558147 63856703
Drug abuse 41.06 10.40 68 83814 132306 64282544
Conjunctivitis 40.65 10.40 85 83797 20269 64394581
Pleuritic pain 40.00 10.40 51 83831 8045 64406805
Viral upper respiratory tract infection 39.41 10.40 51 83831 8164 64406686
Gait disturbance 39.38 10.40 369 83513 171786 64243064
Injection site pain 39.37 10.40 264 83618 111144 64303706
Crepitations 39.33 10.40 50 83832 7865 64406985
Tenderness 39.31 10.40 82 83800 19520 64395330
Lipoma 38.88 10.40 30 83852 2569 64412281
Leukopenia 38.40 10.40 45 83837 101197 64313653
Cardiac failure 38.33 10.40 71 83811 132302 64282548
Cushingoid 37.73 10.40 48 83834 7555 64407295
Injection site reaction 36.92 10.40 139 83743 46525 64368325
Musculoskeletal discomfort 36.11 10.40 71 83811 16206 64398644
Therapeutic product effect decreased 35.88 10.40 265 83617 115086 64299764
Exposure during pregnancy 35.86 10.40 29 83853 77646 64337204
Mobility decreased 35.66 10.40 212 83670 85628 64329222
Intervertebral disc degeneration 35.07 10.40 62 83820 13058 64401792
Maternal exposure during pregnancy 34.90 10.40 44 83838 95840 64319010
Listless 34.67 10.40 31 83851 3259 64411591
Product use in unapproved indication 34.53 10.40 116 83766 176502 64238348
Drug intolerance 34.43 10.40 385 83497 187607 64227243
Malignant neoplasm progression 34.06 10.40 59 83823 112812 64302038
Injection site bruising 33.61 10.40 114 83768 36259 64378591
Sputum culture positive 32.86 10.40 29 83853 2997 64411853
Bradycardia 32.83 10.40 65 83817 118154 64296696
Flank pain 32.79 10.40 68 83814 16121 64398729
Carpal tunnel syndrome 32.67 10.40 67 83815 15761 64399089
Eye irritation 32.59 10.40 67 83815 15789 64399061
Xyphoid retraction 32.01 10.40 11 83871 162 64414688
Drug interaction 31.45 10.40 310 83572 361773 64053077
Somatic delusion 30.99 10.40 16 83866 674 64414176
Hyponatraemia 30.68 10.40 95 83787 148244 64266606
Platelet count decreased 30.21 10.40 114 83768 167597 64247253
Therapy cessation 30.17 10.40 102 83780 32387 64382463
Hypermobility syndrome 29.10 10.40 14 83868 506 64414344
Bronchial secretion retention 29.02 10.40 25 83857 2502 64412348
Tachycardia 28.71 10.40 99 83783 149480 64265370
Hypoaesthesia 27.83 10.40 290 83592 138818 64276032
Arthrofibrosis 27.80 10.40 9 83873 109 64414741
Depression 27.71 10.40 362 83520 182929 64231921
Ocular hyperaemia 27.61 10.40 78 83804 22486 64392364
Electrocardiogram QT prolonged 27.34 10.40 38 83844 79410 64335440
Disease progression 27.04 10.40 94 83788 141586 64273264
Headache 26.93 10.40 889 82993 528578 63886272
Cardiogenic shock 26.52 10.40 5 83877 32422 64382428
Fixed eruption 26.10 10.40 22 83860 2137 64412713
Cytomegalovirus infection 25.99 10.40 8 83874 37191 64377659
Sepsis 25.96 10.40 184 83698 230157 64184693
Oropharyngeal pain 25.85 10.40 201 83681 88666 64326184
Mucosal inflammation 25.74 10.40 26 83856 62558 64352292
Small intestinal stenosis 25.73 10.40 14 83868 657 64414193
Drug resistance 25.53 10.40 7 83875 35095 64379755
Pleural effusion 24.81 10.40 83 83799 126476 64288374
Foot fracture 24.44 10.40 65 83817 18092 64396758
Head discomfort 24.31 10.40 50 83832 11784 64403066
Neoplasm malignant 24.25 10.40 79 83803 24609 64390241
International normalised ratio increased 24.23 10.40 41 83841 79126 64335724
Hypoxia 24.02 10.40 49 83833 88100 64326750
Road traffic accident 23.84 10.40 91 83791 30654 64384196
Sciatica 23.78 10.40 69 83813 20195 64394655
Therapeutic product effect incomplete 23.74 10.40 222 83660 103260 64311590
Arthropathy 23.63 10.40 251 83631 120716 64294134
Seronegative arthritis 23.43 10.40 23 83859 2720 64412130
Hepatocellular injury 23.34 10.40 15 83867 45220 64369630
Urine odour abnormal 23.27 10.40 31 83851 5105 64409745
Breast cancer 23.20 10.40 87 83795 29061 64385789
Hyperkalaemia 22.92 10.40 62 83820 101067 64313783
Neurotoxicity 22.90 10.40 4 83878 27400 64387450
Pulmonary mass 22.83 10.40 76 83806 23940 64390910
Iritis 22.75 10.40 24 83858 3092 64411758
Dry mouth 22.44 10.40 145 83737 60273 64354577
Ischaemic gastritis 22.43 10.40 5 83877 11 64414839
Sinusitis 22.38 10.40 289 83593 145639 64269211
Injection site vesicles 22.30 10.40 22 83860 2618 64412232
Eyelid retraction 22.25 10.40 6 83876 36 64414814
Cataract 22.19 10.40 128 83754 51134 64363716
Agranulocytosis 22.13 10.40 11 83871 38218 64376632
Blood creatinine increased 22.12 10.40 96 83786 135686 64279164
Rheumatoid nodule 22.04 10.40 50 83832 12601 64402249
Bone marrow failure 22.01 10.40 18 83864 47934 64366916
Hypoglycaemia 22.00 10.40 53 83829 89839 64325011
Pemphigus 21.94 10.40 28 83854 60673 64354177
Upper-airway cough syndrome 21.60 10.40 40 83842 8730 64406120
Injection site pruritus 21.59 10.40 102 83780 37724 64377126
Finger deformity 21.52 10.40 30 83852 5156 64409694
Surgery 21.46 10.40 83 83799 28130 64386720
Poliomyelitis 20.87 10.40 6 83876 47 64414803
Intentional self-injury 20.74 10.40 6 83876 29038 64385812
Hepatic failure 20.60 10.40 25 83857 55369 64359481
Respiratory failure 20.56 10.40 124 83758 161059 64253791
Spinal operation 20.44 10.40 32 83850 6101 64408749
Cholestasis 20.40 10.40 17 83865 44855 64369995
Pulmonary oedema 20.37 10.40 45 83837 78629 64336221
Multiple allergies 20.30 10.40 31 83851 5783 64409067
Neutrophil count decreased 20.12 10.40 44 83838 77152 64337698
Eye pain 20.08 10.40 88 83794 31537 64383313
Posterior reversible encephalopathy syndrome 19.95 10.40 3 83879 22943 64391907
Exostosis 19.69 10.40 45 83837 11393 64403457
Rhabdomyolysis 19.49 10.40 58 83824 91668 64323182
Limb asymmetry 19.43 10.40 11 83871 558 64414292
Blood bilirubin increased 19.33 10.40 28 83854 57525 64357325
Intentional overdose 19.02 10.40 57 83825 89887 64324963
Loss of personal independence in daily activities 18.97 10.40 160 83722 72294 64342556
Lymphomatoid papulosis 18.92 10.40 9 83873 317 64414533
Joint stiffness 18.85 10.40 84 83798 30320 64384530
Pneumonia aspiration 18.79 10.40 30 83852 59241 64355609
Clostridium difficile colitis 18.76 10.40 6 83876 27217 64387633
Reduced facial expression 18.58 10.40 18 83864 2095 64412755
Intervertebral disc protrusion 18.40 10.40 63 83819 20128 64394722
Hepatotoxicity 18.34 10.40 15 83867 39947 64374903
Right ventricular failure 18.24 10.40 3 83879 21468 64393382
Foot deformity 18.22 10.40 55 83827 16449 64398401
Gastrointestinal haemorrhage 18.21 10.40 257 83625 132055 64282795
Ascites 18.17 10.40 33 83849 61968 64352882
Manipulation 18.15 10.40 6 83876 78 64414772
Respiratory distress 18.03 10.40 25 83857 52306 64362544
Vertigo 18.01 10.40 135 83747 58876 64355974
Injection site warmth 17.92 10.40 48 83834 13414 64401436
Allergy to chemicals 17.81 10.40 13 83869 1024 64413826
Malaise 17.06 10.40 653 83229 395594 64019256
Oesophageal infection 17.04 10.40 10 83872 543 64414307
Stress fracture 16.90 10.40 28 83854 5596 64409254
Eosinophilia 16.61 10.40 15 83867 38061 64376789
Sacroiliitis 16.53 10.40 20 83862 2992 64411858
Blood creatine phosphokinase increased 16.42 10.40 32 83850 58526 64356324
Oesophageal mucosal tear 16.37 10.40 4 83878 15 64414835
Pharyngeal paraesthesia 16.24 10.40 16 83866 1901 64412949
Nodular rash 16.07 10.40 8 83874 312 64414538
Hypokalaemia 15.96 10.40 93 83789 121810 64293040
Tumour lysis syndrome 15.89 10.40 3 83879 19437 64395413
Cardiac failure congestive 15.85 10.40 102 83780 130478 64284372
Grip strength decreased 15.81 10.40 42 83840 11682 64403168
Tendon disorder 15.75 10.40 29 83853 6303 64408547
Knee operation 15.50 10.40 24 83858 4533 64410317
Pneumonitis 15.49 10.40 26 83856 50339 64364511
Bronchopulmonary aspergillosis 15.48 10.40 3 83879 19082 64395768
Hypercalcaemia 15.43 10.40 11 83871 31405 64383445
Haematuria 15.32 10.40 35 83847 60436 64354414
Tarsal tunnel syndrome 15.22 10.40 9 83873 496 64414354
Atelectasis 15.18 10.40 73 83809 27193 64387657
Glossodynia 15.16 10.40 39 83843 64657 64350193
Aggression 15.03 10.40 23 83859 46209 64368641
Abortion spontaneous 14.91 10.40 7 83875 25136 64389714
Cartilage injury 14.88 10.40 13 83869 1326 64413524
Arthritis infective 14.79 10.40 30 83852 7000 64407850
Neuroleptic malignant syndrome 14.76 10.40 7 83875 24989 64389861
Memory impairment 14.55 10.40 173 83709 85509 64329341
Muscle spasms 14.53 10.40 261 83621 140762 64274088
Epistaxis 14.43 10.40 72 83810 98059 64316791
Chromaturia 14.42 10.40 63 83819 22548 64392302
Pericarditis 14.41 10.40 38 83844 62478 64352372
Thalassaemia minor 14.18 10.40 4 83878 29 64414821
Knee arthroplasty 14.11 10.40 71 83811 26928 64387922
Dizziness 14.06 10.40 689 83193 429474 63985376
Syncope 14.06 10.40 134 83748 157501 64257349
Cellulitis gangrenous 14.06 10.40 7 83875 273 64414577
Trigger finger 13.96 10.40 20 83862 3525 64411325
Muscular weakness 13.95 10.40 238 83644 127100 64287750
Hepatic encephalopathy 13.90 10.40 5 83877 21061 64393789
Pelvic adhesions 13.71 10.40 7 83875 288 64414562
Pulmonary arterial hypertension 13.66 10.40 8 83874 25359 64389491
Rash pruritic 13.59 10.40 124 83758 57280 64357570
Myelosuppression 13.58 10.40 7 83875 23823 64391027
Antinuclear antibody 13.51 10.40 8 83874 442 64414408
Influenza 13.50 10.40 204 83678 106327 64308523
Device related infection 13.44 10.40 12 83870 30614 64384236
Cerebral haemorrhage 13.41 10.40 29 83853 51061 64363789
Nephrolithiasis 13.37 10.40 100 83782 43583 64371267
Duodenal ulcer haemorrhage 13.32 10.40 27 83855 6298 64408552
Upper respiratory tract infection 13.27 10.40 149 83733 72636 64342214
Rheumatic fever 13.25 10.40 34 83848 9260 64405590
Seizure 13.19 10.40 146 83736 166746 64248104
Sedation 13.13 10.40 21 83861 41441 64373409
Rotator cuff syndrome 13.04 10.40 40 83842 12067 64402783
Macrophages increased 12.95 10.40 6 83876 199 64414651
Suicide attempt 12.95 10.40 48 83834 70959 64343891
Treatment noncompliance 12.87 10.40 23 83859 43459 64371391
Foreign body 12.86 10.40 16 83866 2463 64412387
Abdominal pain upper 12.80 10.40 308 83574 174722 64240128
Hyperglycaemia 12.63 10.40 39 83843 60929 64353921
Small intestinal ulcer haemorrhage 12.61 10.40 5 83877 112 64414738
Progressive multifocal leukoencephalopathy 12.60 10.40 4 83878 18228 64396622
Purpura senile 12.57 10.40 8 83874 503 64414347
Bacteraemia 12.48 10.40 10 83872 26901 64387949
Renal failure 12.43 10.40 164 83718 181524 64233326
Aspergillus infection 12.42 10.40 3 83879 16376 64398474
Pelvic fracture 12.42 10.40 36 83846 10527 64404323
Neuralgia 12.40 10.40 67 83815 26117 64388733
Ulcer 12.40 10.40 61 83821 22929 64391921
Anhidrosis 12.39 10.40 6 83876 220 64414630
Abnormal faeces 12.33 10.40 25 83857 5834 64409016
Subdural haematoma 12.30 10.40 11 83871 28043 64386807
Fatigue 12.22 10.40 1131 82751 747599 63667251
Body temperature increased 12.15 10.40 18 83864 36648 64378202
Injection site urticaria 12.10 10.40 37 83845 11144 64403706
Gastric mucosal hypertrophy 12.10 10.40 6 83876 232 64414618
Muscle injury 12.04 10.40 10 83872 26427 64388423
Affect lability 11.91 10.40 32 83850 8958 64405892
Sleep disorder due to general medical condition, insomnia type 11.88 10.40 10 83872 26260 64388590
Orthostatic hypotension 11.88 10.40 27 83855 46711 64368139
Gastric ulcer haemorrhage 11.83 10.40 30 83852 8113 64406737
Ejection fraction decreased 11.72 10.40 12 83870 28695 64386155
Barrett's oesophagus 11.71 10.40 9 83873 766 64414084
Dysphagia 11.69 10.40 86 83796 106726 64308124
Dystonia 11.58 10.40 5 83877 18860 64395990
Oedema peripheral 11.58 10.40 198 83684 210119 64204731
Vaginal infection 11.57 10.40 22 83860 4898 64409952
Prostatic specific antigen increased 11.43 10.40 31 83851 8729 64406121
Increased tendency to bruise 11.33 10.40 32 83850 9223 64405627
Gait inability 11.32 10.40 94 83788 42274 64372576
Confusional state 11.30 10.40 256 83626 260888 64153962
Anxiety 11.23 10.40 344 83538 202305 64212545
Meralgia paraesthetica 11.16 10.40 6 83876 275 64414575
Infection 11.10 10.40 317 83565 184563 64230287
Ligament rupture 11.02 10.40 15 83867 2521 64412329
Bipolar disorder 10.98 10.40 26 83856 6735 64408115
Hyperbilirubinaemia 10.98 10.40 7 83875 21198 64393652
Lower respiratory tract infection 10.93 10.40 75 83807 94539 64320311
Injection site rash 10.92 10.40 45 83837 15697 64399153
Sneezing 10.90 10.40 44 83838 15207 64399643
Vaginal neoplasm 10.85 10.40 4 83878 73 64414777
Dysphoria 10.79 10.40 20 83862 4368 64410482
Back disorder 10.76 10.40 33 83849 9957 64404893
Swelling face 10.73 10.40 121 83761 59045 64355805
Hepatic cirrhosis 10.73 10.40 11 83871 26287 64388563
Dysstasia 10.73 10.40 59 83823 23156 64391694
Lung infiltration 10.68 10.40 7 83875 20882 64393968
Splenomegaly 10.65 10.40 5 83877 17956 64396894
Spinal stenosis 10.61 10.40 41 83841 13890 64400960
Intentional dose omission 10.59 10.40 23 83859 5629 64409221
Intentional product misuse 10.58 10.40 142 83740 72153 64342697
Paraesthesia 10.53 10.40 239 83643 134283 64280567
Dandruff 10.52 10.40 6 83876 309 64414541
Benign vaginal neoplasm 10.51 10.40 4 83878 80 64414770
Ear infection 10.49 10.40 59 83823 23345 64391505

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC M01AC06 MUSCULO-SKELETAL SYSTEM
ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS
ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS, NON-STEROIDS
Oxicams
ATC M01AC56 MUSCULO-SKELETAL SYSTEM
ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS
ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS, NON-STEROIDS
Oxicams
ATC N01BB59 NERVOUS SYSTEM
ANESTHETICS
ANESTHETICS, LOCAL
Amides
FDA CS M0001335 Anti-Inflammatory Agents, Non-Steroidal
FDA MoA N0000000160 Cyclooxygenase Inhibitors
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 D052246 Cyclooxygenase 2 Inhibitors
MeSH PA D016861 Cyclooxygenase Inhibitors
MeSH PA D004791 Enzyme Inhibitors
MeSH PA D018373 Peripheral Nervous System Agents
MeSH PA D018689 Sensory System Agents
CHEBI has role CHEBI:35475 non-steroidal anti-inflammatory agent
CHEBI has role CHEBI:35842 anti-rheumatic drugs
CHEBI has role CHEBI:50629 COX-2 inhibitor
FDA EPC N0000175722 Nonsteroidal Anti-inflammatory Drug

Drug Use | Suggest Off label Use Form| |View source of the data|

DiseaseRelationSNOMED_IDDOID
Rheumatoid arthritis indication 69896004 DOID:7148
Osteoarthritis indication 396275006
Juvenile rheumatoid arthritis indication 410795001
Ankylosing spondylitis off-label use 9631008 DOID:7147
Gastritis contraindication 4556007 DOID:4029
Alcoholism contraindication 7200002
Myocardial infarction contraindication 22298006 DOID:5844
Hypertensive disorder contraindication 38341003 DOID:10763
Gastrointestinal ulcer contraindication 40845000
Body fluid retention contraindication 43498006
Chronic heart failure contraindication 48447003
Disorder of cardiovascular system contraindication 49601007 DOID:1287
Gastrointestinal perforation contraindication 51875005
Hyperlipidemia contraindication 55822004 DOID:1168
Blood coagulation disorder contraindication 64779008 DOID:1247
Aortocoronary artery bypass graft contraindication 67166004
Diabetes mellitus contraindication 73211009 DOID:9351
Gastrointestinal hemorrhage contraindication 74474003
Kidney disease contraindication 90708001 DOID:557
Liver function tests abnormal contraindication 166603001
Impaired renal function disorder contraindication 197663003
Cerebrovascular accident contraindication 230690007
Coronary artery bypass graft contraindication 232717009
Edema contraindication 267038008
Anemia contraindication 271737000 DOID:2355
Pregnancy, function contraindication 289908002
Thromboembolic disorder contraindication 371039008
Cardiovascular event risk contraindication 395112001
Smokes tobacco daily contraindication 449868002




🐶 Veterinary Drug Use

SpeciesUseRelation
Cats Postoperative pain and inflammation associated with orthopedic surgery Indication
Cats Postoperative pain and inflammation associated with ovariohysterectomy Indication
Cats Postoperative pain and inflammation associated with castration Indication
Dogs Pain and inflammation associated with osteoarthritis Indication

🐶 Veterinary products

ProductApplicantIngredients
Metacam Oral Suspension Boehringer lngelheim Animal Health USA Inc. 1
Metacam 5 mg/mL Solution for Injection Boehringer lngelheim Animal Health USA Inc. 1
OroCAM Transmucosal Oral Spray Zoetis Inc. 1
Meloxicam Injection Accord Healthcare Inc. 1
Loxicom Norbrook Laboratories, Ltd. 1
Loxicom Norbrook Laboratories, Ltd. 1
Meloxicam Solution for Injection Dechra Veterinary Products LLC 1
Meloxidyl Ceva Sante Animale 1

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 3.65 acidic
pKa2 5.42 acidic
pKa3 4.32 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
30MG/ML (30MG/ML) ANJESO BAUDAX N210583 Feb. 20, 2020 RX SOLUTION INTRAVENOUS 8512727 Dec. 25, 2022 MANAGEMENT OF MODERATE-TO-SEVERE PAIN BY INTRAVENOUS INJECTION
30MG/ML (30MG/ML) ANJESO BAUDAX N210583 Feb. 20, 2020 RX SOLUTION INTRAVENOUS 10463673 Feb. 24, 2024 MANAGEMENT OF MODERATE-TO-SEVERE PAIN BY INTRAVENOUS INJECTION
30MG/ML (30MG/ML) ANJESO BAUDAX N210583 Feb. 20, 2020 RX SOLUTION INTRAVENOUS 10471067 Feb. 24, 2024 MANAGEMENT OF MODERATE-TO-SEVERE PAIN BY INTRAVENOUS INJECTION
30MG/ML (30MG/ML) ANJESO BAUDAX N210583 Feb. 20, 2020 RX SOLUTION INTRAVENOUS 10709713 May 26, 2030 MANAGEMENT OF MODERATE-TO-SEVERE PAIN BY INTRAVENOUS INJECTION
30MG/ML (30MG/ML) ANJESO BAUDAX N210583 Feb. 20, 2020 RX SOLUTION INTRAVENOUS 11253478 May 26, 2030 MANAGEMENT OF MODERATE-TO-SEVERE PAIN BY INJECTION
200MG/7ML (29.25MG/ML);6MG/7ML (0.88MG/ML) ZYNRELEF KIT HERON THERAPS INC N211988 May 12, 2021 RX SOLUTION, EXTENDED RELEASE PERIARTICULAR 11253504 March 13, 2034 TREATMENT OF POSTSURGICAL PAIN PROVIDING ANALGESIA TO A PATIENT FOR UP TO 72 HOURS, FOR EXAMPLE, AFTER BUNIONECTOMY, OPEN INGUINAL HERNIORRHAPHY, OR TOTAL KNEE ARTHROPLASTY VIA SOFT TISSUE OR PERIARTICULAR INSTILLATION
200MG/7ML (29.25MG/ML);6MG/7ML (0.88MG/ML) ZYNRELEF KIT HERON THERAPS INC N211988 May 12, 2021 RX SOLUTION, EXTENDED RELEASE PERIARTICULAR 9592227 March 13, 2034 TREATMENT OF POSTSURGICAL PAIN PROVIDING ANALGESIA TO A PATIENT FOR UP TO 72 HOURS, FOR EXAMPLE, AFTER BUNIONECTOMY, OPEN INGUINAL HERNIORRHAPHY, OR TOTAL KNEE ARTHROPLASTY VIA SOFT TISSUE OR PERIARTICULAR INSTILLATION
200MG/7ML (29.25MG/ML);6MG/7ML (0.88MG/ML) ZYNRELEF KIT HERON THERAPS INC N211988 May 12, 2021 RX SOLUTION, EXTENDED RELEASE PERIARTICULAR 9913909 March 13, 2034 TREATMENT OF POSTSURGICAL PAIN PROVIDING ANALGESIA TO A PATIENT FOR UP TO 72 HOURS, FOR EXAMPLE, AFTER BUNIONECTOMY, OPEN INGUINAL HERNIORRHAPHY, OR TOTAL KNEE ARTHROPLASTY VIA SOFT TISSUE OR PERIARTICULAR INSTILLATION
300MG/10.5ML (29.25MG/ML);9MG/10.5ML (0.88MG/ML) ZYNRELEF KIT HERON THERAPS INC N211988 May 12, 2021 DISCN SOLUTION, EXTENDED RELEASE PERIARTICULAR 11253504 March 13, 2034 TREATMENT OF POSTSURGICAL PAIN PROVIDING ANALGESIA TO A PATIENT FOR UP TO 72 HOURS, FOR EXAMPLE, AFTER BUNIONECTOMY, OPEN INGUINAL HERNIORRHAPHY, OR TOTAL KNEE ARTHROPLASTY VIA SOFT TISSUE OR PERIARTICULAR INSTILLATION
300MG/10.5ML (29.25MG/ML);9MG/10.5ML (0.88MG/ML) ZYNRELEF KIT HERON THERAPS INC N211988 May 12, 2021 DISCN SOLUTION, EXTENDED RELEASE PERIARTICULAR 9592227 March 13, 2034 TREATMENT OF POSTSURGICAL PAIN PROVIDING ANALGESIA TO A PATIENT FOR UP TO 72 HOURS, FOR EXAMPLE, AFTER BUNIONECTOMY, OPEN INGUINAL HERNIORRHAPHY, OR TOTAL KNEE ARTHROPLASTY VIA SOFT TISSUE OR PERIARTICULAR INSTILLATION
300MG/10.5ML (29.25MG/ML);9MG/10.5ML (0.88MG/ML) ZYNRELEF KIT HERON THERAPS INC N211988 May 12, 2021 DISCN SOLUTION, EXTENDED RELEASE PERIARTICULAR 9913909 March 13, 2034 TREATMENT OF POSTSURGICAL PAIN PROVIDING ANALGESIA TO A PATIENT FOR UP TO 72 HOURS, FOR EXAMPLE, AFTER BUNIONECTOMY, OPEN INGUINAL HERNIORRHAPHY, OR TOTAL KNEE ARTHROPLASTY VIA SOFT TISSUE OR PERIARTICULAR INSTILLATION
400MG/14ML (29.25MG/ML);12MG/14ML (0.88MG/ML) ZYNRELEF KIT HERON THERAPS INC N211988 May 12, 2021 RX SOLUTION, EXTENDED RELEASE PERIARTICULAR 11253504 March 13, 2034 TREATMENT OF POSTSURGICAL PAIN PROVIDING ANALGESIA TO A PATIENT FOR UP TO 72 HOURS, FOR EXAMPLE, AFTER BUNIONECTOMY, OPEN INGUINAL HERNIORRHAPHY, OR TOTAL KNEE ARTHROPLASTY VIA SOFT TISSUE OR PERIARTICULAR INSTILLATION
400MG/14ML (29.25MG/ML);12MG/14ML (0.88MG/ML) ZYNRELEF KIT HERON THERAPS INC N211988 May 12, 2021 RX SOLUTION, EXTENDED RELEASE PERIARTICULAR 9592227 March 13, 2034 TREATMENT OF POSTSURGICAL PAIN PROVIDING ANALGESIA TO A PATIENT FOR UP TO 72 HOURS, FOR EXAMPLE, AFTER BUNIONECTOMY, OPEN INGUINAL HERNIORRHAPHY, OR TOTAL KNEE ARTHROPLASTY VIA SOFT TISSUE OR PERIARTICULAR INSTILLATION
400MG/14ML (29.25MG/ML);12MG/14ML (0.88MG/ML) ZYNRELEF KIT HERON THERAPS INC N211988 May 12, 2021 RX SOLUTION, EXTENDED RELEASE PERIARTICULAR 9913909 March 13, 2034 TREATMENT OF POSTSURGICAL PAIN PROVIDING ANALGESIA TO A PATIENT FOR UP TO 72 HOURS, FOR EXAMPLE, AFTER BUNIONECTOMY, OPEN INGUINAL HERNIORRHAPHY, OR TOTAL KNEE ARTHROPLASTY VIA SOFT TISSUE OR PERIARTICULAR INSTILLATION
60MG/2.3ML (29.25MG/ML);1.8MG/2.3ML (0.88MG/ML) ZYNRELEF KIT HERON THERAPS INC N211988 May 12, 2021 DISCN SOLUTION, EXTENDED RELEASE PERIARTICULAR 11253504 March 13, 2034 TREATMENT OF POSTSURGICAL PAIN PROVIDING ANALGESIA TO A PATIENT FOR UP TO 72 HOURS, FOR EXAMPLE, AFTER BUNIONECTOMY, OPEN INGUINAL HERNIORRHAPHY, OR TOTAL KNEE ARTHROPLASTY VIA SOFT TISSUE OR PERIARTICULAR INSTILLATION
60MG/2.3ML (29.25MG/ML);1.8MG/2.3ML (0.88MG/ML) ZYNRELEF KIT HERON THERAPS INC N211988 May 12, 2021 DISCN SOLUTION, EXTENDED RELEASE PERIARTICULAR 9592227 March 13, 2034 TREATMENT OF POSTSURGICAL PAIN PROVIDING ANALGESIA TO A PATIENT FOR UP TO 72 HOURS, FOR EXAMPLE, AFTER BUNIONECTOMY, OPEN INGUINAL HERNIORRHAPHY, OR TOTAL KNEE ARTHROPLASTY VIA SOFT TISSUE OR PERIARTICULAR INSTILLATION
60MG/2.3ML (29.25MG/ML);1.8MG/2.3ML (0.88MG/ML) ZYNRELEF KIT HERON THERAPS INC N211988 May 12, 2021 DISCN SOLUTION, EXTENDED RELEASE PERIARTICULAR 9913909 March 13, 2034 TREATMENT OF POSTSURGICAL PAIN PROVIDING ANALGESIA TO A PATIENT FOR UP TO 72 HOURS, FOR EXAMPLE, AFTER BUNIONECTOMY, OPEN INGUINAL HERNIORRHAPHY, OR TOTAL KNEE ARTHROPLASTY VIA SOFT TISSUE OR PERIARTICULAR INSTILLATION
10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** VIVLODEX ICEUTICA OPERATIONS N207233 Oct. 22, 2015 DISCN CAPSULE ORAL 9808468 March 31, 2035 MANAGEMENT OF OSTEOARTHRITIS PAIN BY ADMINISTERING 10 MG OF MELOXICAM
10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** VIVLODEX ICEUTICA OPERATIONS N207233 Oct. 22, 2015 DISCN CAPSULE ORAL 9808468 March 31, 2035 MANAGEMENT OF OSTEOARTHRITIS PAIN BY ADMINISTERING 5 MG OF MELOXICAM
5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** VIVLODEX ICEUTICA OPERATIONS N207233 Oct. 22, 2015 DISCN CAPSULE ORAL 9808468 March 31, 2035 MANAGEMENT OF OSTEOARTHRITIS PAIN BY ADMINISTERING 10 MG OF MELOXICAM
5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** VIVLODEX ICEUTICA OPERATIONS N207233 Oct. 22, 2015 DISCN CAPSULE ORAL 9808468 March 31, 2035 MANAGEMENT OF OSTEOARTHRITIS PAIN BY ADMINISTERING 5 MG OF MELOXICAM
200MG/7ML (29.25MG/ML);6MG/7ML (0.88MG/ML) ZYNRELEF KIT HERON THERAPS INC N211988 May 12, 2021 RX SOLUTION, EXTENDED RELEASE PERIARTICULAR 10098957 April 20, 2035 TREATMENT OF POSTSURGICAL PAIN PROVIDING ANALGESIA TO A PATIENT FOR UP TO 72 HOURS, FOR EXAMPLE, AFTER BUNIONECTOMY, OPEN INGUINAL HERNIORRHAPHY, OR TOTAL KNEE ARTHROPLASTY VIA SOFT TISSUE OR PERIARTICULAR INSTILLATION
200MG/7ML (29.25MG/ML);6MG/7ML (0.88MG/ML) ZYNRELEF KIT HERON THERAPS INC N211988 May 12, 2021 RX SOLUTION, EXTENDED RELEASE PERIARTICULAR 10213510 April 20, 2035 TREATMENT OF POSTSURGICAL PAIN PROVIDING ANALGESIA TO A PATIENT FOR UP TO 72 HOURS, FOR EXAMPLE, AFTER BUNIONECTOMY, OPEN INGUINAL HERNIORRHAPHY, OR TOTAL KNEE ARTHROPLASTY VIA SOFT TISSUE OR PERIARTICULAR INSTILLATION
200MG/7ML (29.25MG/ML);6MG/7ML (0.88MG/ML) ZYNRELEF KIT HERON THERAPS INC N211988 May 12, 2021 RX SOLUTION, EXTENDED RELEASE PERIARTICULAR 10632199 April 20, 2035 TREATMENT OF POSTSURGICAL PAIN PROVIDING ANALGESIA TO A PATIENT FOR UP TO 72 HOURS, FOR EXAMPLE, AFTER BUNIONECTOMY, OPEN INGUINAL HERNIORRHAPHY, OR TOTAL KNEE ARTHROPLASTY VIA SOFT TISSUE OR PERIARTICULAR INSTILLATION
200MG/7ML (29.25MG/ML);6MG/7ML (0.88MG/ML) ZYNRELEF KIT HERON THERAPS INC N211988 May 12, 2021 RX SOLUTION, EXTENDED RELEASE PERIARTICULAR 10898575 April 20, 2035 TREATMENT OF POSTSURGICAL PAIN PROVIDING ANALGESIA TO A PATIENT FOR UP TO 72 HOURS, FOR EXAMPLE, AFTER BUNIONECTOMY, OPEN INGUINAL HERNIORRHAPHY, OR TOTAL KNEE ARTHROPLASTY VIA SOFT TISSUE OR PERIARTICULAR INSTILLATION
200MG/7ML (29.25MG/ML);6MG/7ML (0.88MG/ML) ZYNRELEF KIT HERON THERAPS INC N211988 May 12, 2021 RX SOLUTION, EXTENDED RELEASE PERIARTICULAR 11083730 April 20, 2035 TREATMENT OF POSTSURGICAL PAIN PROVIDING ANALGESIA TO A PATIENT FOR UP TO 72 HOURS, FOR EXAMPLE, AFTER BUNIONECTOMY, OPEN INGUINAL HERNIORRHAPHY, OR TOTAL KNEE ARTHROPLASTY VIA SOFT TISSUE OR PERIARTICULAR INSTILLATION
200MG/7ML (29.25MG/ML);6MG/7ML (0.88MG/ML) ZYNRELEF KIT HERON THERAPS INC N211988 May 12, 2021 RX SOLUTION, EXTENDED RELEASE PERIARTICULAR 11083797 April 20, 2035 TREATMENT OF POSTSURGICAL PAIN PROVIDING ANALGESIA TO A PATIENT FOR UP TO 72 HOURS, FOR EXAMPLE, AFTER BUNIONECTOMY, OPEN INGUINAL HERNIORRHAPHY, OR TOTAL KNEE ARTHROPLASTY VIA SOFT TISSUE OR PERIARTICULAR INSTILLATION
200MG/7ML (29.25MG/ML);6MG/7ML (0.88MG/ML) ZYNRELEF KIT HERON THERAPS INC N211988 May 12, 2021 RX SOLUTION, EXTENDED RELEASE PERIARTICULAR 9694079 April 20, 2035 TREATMENT OF POSTSURGICAL PAIN PROVIDING ANALGESIA TO A PATIENT FOR UP TO 72 HOURS, FOR EXAMPLE, AFTER BUNIONECTOMY, OPEN INGUINAL HERNIORRHAPHY, OR TOTAL KNEE ARTHROPLASTY VIA SOFT TISSUE OR PERIARTICULAR INSTILLATION
200MG/7ML (29.25MG/ML);6MG/7ML (0.88MG/ML) ZYNRELEF KIT HERON THERAPS INC N211988 May 12, 2021 RX SOLUTION, EXTENDED RELEASE PERIARTICULAR 9801945 April 20, 2035 TREATMENT OF POSTSURGICAL PAIN PROVIDING ANALGESIA TO A PATIENT FOR UP TO 72 HOURS, FOR EXAMPLE, AFTER BUNIONECTOMY, OPEN INGUINAL HERNIORRHAPHY, OR TOTAL KNEE ARTHROPLASTY VIA SOFT TISSUE OR PERIARTICULAR INSTILLATION
300MG/10.5ML (29.25MG/ML);9MG/10.5ML (0.88MG/ML) ZYNRELEF KIT HERON THERAPS INC N211988 May 12, 2021 DISCN SOLUTION, EXTENDED RELEASE PERIARTICULAR 10098957 April 20, 2035 TREATMENT OF POSTSURGICAL PAIN PROVIDING ANALGESIA TO A PATIENT FOR UP TO 72 HOURS, FOR EXAMPLE, AFTER BUNIONECTOMY, OPEN INGUINAL HERNIORRHAPHY, OR TOTAL KNEE ARTHROPLASTY VIA SOFT TISSUE OR PERIARTICULAR INSTILLATION
300MG/10.5ML (29.25MG/ML);9MG/10.5ML (0.88MG/ML) ZYNRELEF KIT HERON THERAPS INC N211988 May 12, 2021 DISCN SOLUTION, EXTENDED RELEASE PERIARTICULAR 10213510 April 20, 2035 TREATMENT OF POSTSURGICAL PAIN PROVIDING ANALGESIA TO A PATIENT FOR UP TO 72 HOURS, FOR EXAMPLE, AFTER BUNIONECTOMY, OPEN INGUINAL HERNIORRHAPHY, OR TOTAL KNEE ARTHROPLASTY VIA SOFT TISSUE OR PERIARTICULAR INSTILLATION
300MG/10.5ML (29.25MG/ML);9MG/10.5ML (0.88MG/ML) ZYNRELEF KIT HERON THERAPS INC N211988 May 12, 2021 DISCN SOLUTION, EXTENDED RELEASE PERIARTICULAR 10632199 April 20, 2035 TREATMENT OF POSTSURGICAL PAIN PROVIDING ANALGESIA TO A PATIENT FOR UP TO 72 HOURS, FOR EXAMPLE, AFTER BUNIONECTOMY, OPEN INGUINAL HERNIORRHAPHY, OR TOTAL KNEE ARTHROPLASTY VIA SOFT TISSUE OR PERIARTICULAR INSTILLATION
300MG/10.5ML (29.25MG/ML);9MG/10.5ML (0.88MG/ML) ZYNRELEF KIT HERON THERAPS INC N211988 May 12, 2021 DISCN SOLUTION, EXTENDED RELEASE PERIARTICULAR 10898575 April 20, 2035 TREATMENT OF POSTSURGICAL PAIN PROVIDING ANALGESIA TO A PATIENT FOR UP TO 72 HOURS, FOR EXAMPLE, AFTER BUNIONECTOMY, OPEN INGUINAL HERNIORRHAPHY, OR TOTAL KNEE ARTHROPLASTY VIA SOFT TISSUE OR PERIARTICULAR INSTILLATION
300MG/10.5ML (29.25MG/ML);9MG/10.5ML (0.88MG/ML) ZYNRELEF KIT HERON THERAPS INC N211988 May 12, 2021 DISCN SOLUTION, EXTENDED RELEASE PERIARTICULAR 11083730 April 20, 2035 TREATMENT OF POSTSURGICAL PAIN PROVIDING ANALGESIA TO A PATIENT FOR UP TO 72 HOURS, FOR EXAMPLE, AFTER BUNIONECTOMY, OPEN INGUINAL HERNIORRHAPHY, OR TOTAL KNEE ARTHROPLASTY VIA SOFT TISSUE OR PERIARTICULAR INSTILLATION
300MG/10.5ML (29.25MG/ML);9MG/10.5ML (0.88MG/ML) ZYNRELEF KIT HERON THERAPS INC N211988 May 12, 2021 DISCN SOLUTION, EXTENDED RELEASE PERIARTICULAR 11083797 April 20, 2035 TREATMENT OF POSTSURGICAL PAIN PROVIDING ANALGESIA TO A PATIENT FOR UP TO 72 HOURS, FOR EXAMPLE, AFTER BUNIONECTOMY, OPEN INGUINAL HERNIORRHAPHY, OR TOTAL KNEE ARTHROPLASTY VIA SOFT TISSUE OR PERIARTICULAR INSTILLATION
300MG/10.5ML (29.25MG/ML);9MG/10.5ML (0.88MG/ML) ZYNRELEF KIT HERON THERAPS INC N211988 May 12, 2021 DISCN SOLUTION, EXTENDED RELEASE PERIARTICULAR 9694079 April 20, 2035 TREATMENT OF POSTSURGICAL PAIN PROVIDING ANALGESIA TO A PATIENT FOR UP TO 72 HOURS, FOR EXAMPLE, AFTER BUNIONECTOMY, OPEN INGUINAL HERNIORRHAPHY, OR TOTAL KNEE ARTHROPLASTY VIA SOFT TISSUE OR PERIARTICULAR INSTILLATION
300MG/10.5ML (29.25MG/ML);9MG/10.5ML (0.88MG/ML) ZYNRELEF KIT HERON THERAPS INC N211988 May 12, 2021 DISCN SOLUTION, EXTENDED RELEASE PERIARTICULAR 9801945 April 20, 2035 TREATMENT OF POSTSURGICAL PAIN PROVIDING ANALGESIA TO A PATIENT FOR UP TO 72 HOURS, FOR EXAMPLE, AFTER BUNIONECTOMY, OPEN INGUINAL HERNIORRHAPHY, OR TOTAL KNEE ARTHROPLASTY VIA SOFT TISSUE OR PERIARTICULAR INSTILLATION
400MG/14ML (29.25MG/ML);12MG/14ML (0.88MG/ML) ZYNRELEF KIT HERON THERAPS INC N211988 May 12, 2021 RX SOLUTION, EXTENDED RELEASE PERIARTICULAR 10098957 April 20, 2035 TREATMENT OF POSTSURGICAL PAIN PROVIDING ANALGESIA TO A PATIENT FOR UP TO 72 HOURS, FOR EXAMPLE, AFTER BUNIONECTOMY, OPEN INGUINAL HERNIORRHAPHY, OR TOTAL KNEE ARTHROPLASTY VIA SOFT TISSUE OR PERIARTICULAR INSTILLATION
400MG/14ML (29.25MG/ML);12MG/14ML (0.88MG/ML) ZYNRELEF KIT HERON THERAPS INC N211988 May 12, 2021 RX SOLUTION, EXTENDED RELEASE PERIARTICULAR 10213510 April 20, 2035 TREATMENT OF POSTSURGICAL PAIN PROVIDING ANALGESIA TO A PATIENT FOR UP TO 72 HOURS, FOR EXAMPLE, AFTER BUNIONECTOMY, OPEN INGUINAL HERNIORRHAPHY, OR TOTAL KNEE ARTHROPLASTY VIA SOFT TISSUE OR PERIARTICULAR INSTILLATION
400MG/14ML (29.25MG/ML);12MG/14ML (0.88MG/ML) ZYNRELEF KIT HERON THERAPS INC N211988 May 12, 2021 RX SOLUTION, EXTENDED RELEASE PERIARTICULAR 10632199 April 20, 2035 TREATMENT OF POSTSURGICAL PAIN PROVIDING ANALGESIA TO A PATIENT FOR UP TO 72 HOURS, FOR EXAMPLE, AFTER BUNIONECTOMY, OPEN INGUINAL HERNIORRHAPHY, OR TOTAL KNEE ARTHROPLASTY VIA SOFT TISSUE OR PERIARTICULAR INSTILLATION
400MG/14ML (29.25MG/ML);12MG/14ML (0.88MG/ML) ZYNRELEF KIT HERON THERAPS INC N211988 May 12, 2021 RX SOLUTION, EXTENDED RELEASE PERIARTICULAR 10898575 April 20, 2035 TREATMENT OF POSTSURGICAL PAIN PROVIDING ANALGESIA TO A PATIENT FOR UP TO 72 HOURS, FOR EXAMPLE, AFTER BUNIONECTOMY, OPEN INGUINAL HERNIORRHAPHY, OR TOTAL KNEE ARTHROPLASTY VIA SOFT TISSUE OR PERIARTICULAR INSTILLATION
400MG/14ML (29.25MG/ML);12MG/14ML (0.88MG/ML) ZYNRELEF KIT HERON THERAPS INC N211988 May 12, 2021 RX SOLUTION, EXTENDED RELEASE PERIARTICULAR 11083730 April 20, 2035 TREATMENT OF POSTSURGICAL PAIN PROVIDING ANALGESIA TO A PATIENT FOR UP TO 72 HOURS, FOR EXAMPLE, AFTER BUNIONECTOMY, OPEN INGUINAL HERNIORRHAPHY, OR TOTAL KNEE ARTHROPLASTY VIA SOFT TISSUE OR PERIARTICULAR INSTILLATION
400MG/14ML (29.25MG/ML);12MG/14ML (0.88MG/ML) ZYNRELEF KIT HERON THERAPS INC N211988 May 12, 2021 RX SOLUTION, EXTENDED RELEASE PERIARTICULAR 11083797 April 20, 2035 TREATMENT OF POSTSURGICAL PAIN PROVIDING ANALGESIA TO A PATIENT FOR UP TO 72 HOURS, FOR EXAMPLE, AFTER BUNIONECTOMY, OPEN INGUINAL HERNIORRHAPHY, OR TOTAL KNEE ARTHROPLASTY VIA SOFT TISSUE OR PERIARTICULAR INSTILLATION
400MG/14ML (29.25MG/ML);12MG/14ML (0.88MG/ML) ZYNRELEF KIT HERON THERAPS INC N211988 May 12, 2021 RX SOLUTION, EXTENDED RELEASE PERIARTICULAR 9694079 April 20, 2035 TREATMENT OF POSTSURGICAL PAIN PROVIDING ANALGESIA TO A PATIENT FOR UP TO 72 HOURS, FOR EXAMPLE, AFTER BUNIONECTOMY, OPEN INGUINAL HERNIORRHAPHY, OR TOTAL KNEE ARTHROPLASTY VIA SOFT TISSUE OR PERIARTICULAR INSTILLATION
400MG/14ML (29.25MG/ML);12MG/14ML (0.88MG/ML) ZYNRELEF KIT HERON THERAPS INC N211988 May 12, 2021 RX SOLUTION, EXTENDED RELEASE PERIARTICULAR 9801945 April 20, 2035 TREATMENT OF POSTSURGICAL PAIN PROVIDING ANALGESIA TO A PATIENT FOR UP TO 72 HOURS, FOR EXAMPLE, AFTER BUNIONECTOMY, OPEN INGUINAL HERNIORRHAPHY, OR TOTAL KNEE ARTHROPLASTY VIA SOFT TISSUE OR PERIARTICULAR INSTILLATION
60MG/2.3ML (29.25MG/ML);1.8MG/2.3ML (0.88MG/ML) ZYNRELEF KIT HERON THERAPS INC N211988 May 12, 2021 DISCN SOLUTION, EXTENDED RELEASE PERIARTICULAR 10098957 April 20, 2035 TREATMENT OF POSTSURGICAL PAIN PROVIDING ANALGESIA TO A PATIENT FOR UP TO 72 HOURS, FOR EXAMPLE, AFTER BUNIONECTOMY, OPEN INGUINAL HERNIORRHAPHY, OR TOTAL KNEE ARTHROPLASTY VIA SOFT TISSUE OR PERIARTICULAR INSTILLATION
60MG/2.3ML (29.25MG/ML);1.8MG/2.3ML (0.88MG/ML) ZYNRELEF KIT HERON THERAPS INC N211988 May 12, 2021 DISCN SOLUTION, EXTENDED RELEASE PERIARTICULAR 10213510 April 20, 2035 TREATMENT OF POSTSURGICAL PAIN PROVIDING ANALGESIA TO A PATIENT FOR UP TO 72 HOURS, FOR EXAMPLE, AFTER BUNIONECTOMY, OPEN INGUINAL HERNIORRHAPHY, OR TOTAL KNEE ARTHROPLASTY VIA SOFT TISSUE OR PERIARTICULAR INSTILLATION
60MG/2.3ML (29.25MG/ML);1.8MG/2.3ML (0.88MG/ML) ZYNRELEF KIT HERON THERAPS INC N211988 May 12, 2021 DISCN SOLUTION, EXTENDED RELEASE PERIARTICULAR 10632199 April 20, 2035 TREATMENT OF POSTSURGICAL PAIN PROVIDING ANALGESIA TO A PATIENT FOR UP TO 72 HOURS, FOR EXAMPLE, AFTER BUNIONECTOMY, OPEN INGUINAL HERNIORRHAPHY, OR TOTAL KNEE ARTHROPLASTY VIA SOFT TISSUE OR PERIARTICULAR INSTILLATION
60MG/2.3ML (29.25MG/ML);1.8MG/2.3ML (0.88MG/ML) ZYNRELEF KIT HERON THERAPS INC N211988 May 12, 2021 DISCN SOLUTION, EXTENDED RELEASE PERIARTICULAR 10898575 April 20, 2035 TREATMENT OF POSTSURGICAL PAIN PROVIDING ANALGESIA TO A PATIENT FOR UP TO 72 HOURS, FOR EXAMPLE, AFTER BUNIONECTOMY, OPEN INGUINAL HERNIORRHAPHY, OR TOTAL KNEE ARTHROPLASTY VIA SOFT TISSUE OR PERIARTICULAR INSTILLATION
60MG/2.3ML (29.25MG/ML);1.8MG/2.3ML (0.88MG/ML) ZYNRELEF KIT HERON THERAPS INC N211988 May 12, 2021 DISCN SOLUTION, EXTENDED RELEASE PERIARTICULAR 11083730 April 20, 2035 TREATMENT OF POSTSURGICAL PAIN PROVIDING ANALGESIA TO A PATIENT FOR UP TO 72 HOURS, FOR EXAMPLE, AFTER BUNIONECTOMY, OPEN INGUINAL HERNIORRHAPHY, OR TOTAL KNEE ARTHROPLASTY VIA SOFT TISSUE OR PERIARTICULAR INSTILLATION
60MG/2.3ML (29.25MG/ML);1.8MG/2.3ML (0.88MG/ML) ZYNRELEF KIT HERON THERAPS INC N211988 May 12, 2021 DISCN SOLUTION, EXTENDED RELEASE PERIARTICULAR 11083797 April 20, 2035 TREATMENT OF POSTSURGICAL PAIN PROVIDING ANALGESIA TO A PATIENT FOR UP TO 72 HOURS, FOR EXAMPLE, AFTER BUNIONECTOMY, OPEN INGUINAL HERNIORRHAPHY, OR TOTAL KNEE ARTHROPLASTY VIA SOFT TISSUE OR PERIARTICULAR INSTILLATION
60MG/2.3ML (29.25MG/ML);1.8MG/2.3ML (0.88MG/ML) ZYNRELEF KIT HERON THERAPS INC N211988 May 12, 2021 DISCN SOLUTION, EXTENDED RELEASE PERIARTICULAR 9694079 April 20, 2035 TREATMENT OF POSTSURGICAL PAIN PROVIDING ANALGESIA TO A PATIENT FOR UP TO 72 HOURS, FOR EXAMPLE, AFTER BUNIONECTOMY, OPEN INGUINAL HERNIORRHAPHY, OR TOTAL KNEE ARTHROPLASTY VIA SOFT TISSUE OR PERIARTICULAR INSTILLATION
60MG/2.3ML (29.25MG/ML);1.8MG/2.3ML (0.88MG/ML) ZYNRELEF KIT HERON THERAPS INC N211988 May 12, 2021 DISCN SOLUTION, EXTENDED RELEASE PERIARTICULAR 9801945 April 20, 2035 TREATMENT OF POSTSURGICAL PAIN PROVIDING ANALGESIA TO A PATIENT FOR UP TO 72 HOURS, FOR EXAMPLE, AFTER BUNIONECTOMY, OPEN INGUINAL HERNIORRHAPHY, OR TOTAL KNEE ARTHROPLASTY VIA SOFT TISSUE OR PERIARTICULAR INSTILLATION
30MG/ML (30MG/ML) ANJESO BAUDAX N210583 Feb. 20, 2020 RX SOLUTION INTRAVENOUS 10881663 March 8, 2039 MANAGEMENT OF MODERATE-TO-SEVERE PAIN BY INTRAVENOUS INJECTION IN PATIENTS WITH MILD RENAL IMPAIRMENT

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
30MG/ML (30MG/ML) ANJESO BAUDAX N210583 Feb. 20, 2020 RX SOLUTION INTRAVENOUS Feb. 20, 2023 NEW PRODUCT
200MG/7ML (29.25MG/ML);6MG/7ML (0.88MG/ML) ZYNRELEF KIT HERON THERAPS INC N211988 May 12, 2021 RX SOLUTION, EXTENDED RELEASE PERIARTICULAR May 12, 2024 NEW PRODUCT
300MG/10.5ML (29.25MG/ML);9MG/10.5ML (0.88MG/ML) ZYNRELEF KIT HERON THERAPS INC N211988 May 12, 2021 DISCN SOLUTION, EXTENDED RELEASE PERIARTICULAR May 12, 2024 NEW PRODUCT
400MG/14ML (29.25MG/ML);12MG/14ML (0.88MG/ML) ZYNRELEF KIT HERON THERAPS INC N211988 May 12, 2021 RX SOLUTION, EXTENDED RELEASE PERIARTICULAR May 12, 2024 NEW PRODUCT
60MG/2.3ML (29.25MG/ML);1.8MG/2.3ML (0.88MG/ML) ZYNRELEF KIT HERON THERAPS INC N211988 May 12, 2021 DISCN SOLUTION, EXTENDED RELEASE PERIARTICULAR May 12, 2024 NEW PRODUCT

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])		Mechanism
action		Bioact sourceMoA source
Prostaglandin G/H synthase 2 Enzyme INHIBITOR IC50 6.80 CHEMBL CHEMBL
Prostaglandin G/H synthase 1 Enzyme IC50 5.85 CHEMBL
Prostaglandin G/H synthase 2 Enzyme IC50 6.82 CHEMBL
Prostaglandin G/H synthase 1 Enzyme IC50 6 CHEMBL
Prostaglandin G/H synthase 2 Enzyme IC50 5.86 CHEMBL

External reference:

IDSource
4021203 VUID
N0000148649 NUI
D00969 KEGG_DRUG
4021203 VANDF
C0083381 UMLSCUI
CHEBI:6741 CHEBI
MXM PDB_CHEM_ID
CHEMBL599 ChEMBL_ID
DB00814 DRUGBANK_ID
D000077239 MESH_DESCRIPTOR_UI
54677470 PUBCHEM_CID
7220 IUPHAR_LIGAND_ID
5615 INN_ID
VG2QF83CGL UNII
1086708 RXNORM
84146 MMSL
8839 MMSL
d04532 MMSL
006272 NDDF
125694008 SNOMEDCT_US
387055000 SNOMEDCT_US
CHEMBL1256873 ChEMBL_ID

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Meloxicam HUMAN PRESCRIPTION DRUG LABEL 1 0440-5841 TABLET 7.50 mg ORAL ANDA 28 sections
Mobic HUMAN PRESCRIPTION DRUG LABEL 1 0597-0029 TABLET 7.50 mg ORAL NDA 28 sections
Mobic HUMAN PRESCRIPTION DRUG LABEL 1 0597-0029 TABLET 7.50 mg ORAL NDA 28 sections
Mobic HUMAN PRESCRIPTION DRUG LABEL 1 0597-0030 TABLET 15 mg ORAL NDA 28 sections
Mobic HUMAN PRESCRIPTION DRUG LABEL 1 0597-0030 TABLET 15 mg ORAL NDA 28 sections
MELOXICAM HUMAN PRESCRIPTION DRUG LABEL 1 0615-8040 TABLET 7.50 mg ORAL ANDA 26 sections
MELOXICAM HUMAN PRESCRIPTION DRUG LABEL 1 0615-8124 TABLET 15 mg ORAL ANDA 26 sections
Meloxicam HUMAN PRESCRIPTION DRUG LABEL 1 10544-052 TABLET 15 mg ORAL ANDA 31 sections
Meloxicam HUMAN PRESCRIPTION DRUG LABEL 1 10544-090 TABLET 7.50 mg ORAL ANDA 31 sections
Meloxicam HUMAN PRESCRIPTION DRUG LABEL 1 10544-251 TABLET 15 mg ORAL ANDA 27 sections
Meloxicam HUMAN PRESCRIPTION DRUG LABEL 1 10544-252 TABLET 7.50 mg ORAL ANDA 27 sections
meloxicam HUMAN PRESCRIPTION DRUG LABEL 1 10544-555 TABLET 15 mg ORAL ANDA 25 sections
meloxicam HUMAN PRESCRIPTION DRUG LABEL 1 10544-631 TABLET 7.50 mg ORAL ANDA 25 sections
meloxicam HUMAN PRESCRIPTION DRUG LABEL 1 10544-925 TABLET 15 mg ORAL ANDA 26 sections
Meloxicam Human Prescription Drug Label 1 16571-776 TABLET 7.50 mg ORAL ANDA 28 sections
Meloxicam Human Prescription Drug Label 1 16571-777 TABLET 15 mg ORAL ANDA 28 sections
MELOXICAM HUMAN PRESCRIPTION DRUG LABEL 1 16590-434 TABLET 7.50 mg ORAL ANDA 18 sections
MELOXICAM HUMAN PRESCRIPTION DRUG LABEL 1 16590-469 TABLET 15 mg ORAL ANDA 18 sections
Meloxicam HUMAN PRESCRIPTION DRUG LABEL 1 21695-076 TABLET 7.50 mg None ANDA 26 sections
Meloxicam HUMAN PRESCRIPTION DRUG LABEL 1 21695-077 TABLET 15 mg ORAL ANDA 26 sections
meloxicam HUMAN PRESCRIPTION DRUG LABEL 1 29300-124 TABLET 7.50 mg ORAL ANDA 27 sections
meloxicam HUMAN PRESCRIPTION DRUG LABEL 1 29300-125 TABLET 15 mg ORAL ANDA 27 sections
meloxicam HUMAN PRESCRIPTION DRUG LABEL 1 33261-070 TABLET 7.50 mg ORAL ANDA 25 sections
meloxicam HUMAN PRESCRIPTION DRUG LABEL 1 33261-071 TABLET 15 mg ORAL ANDA 25 sections
meloxicam HUMAN PRESCRIPTION DRUG LABEL 1 35356-808 TABLET 7.50 mg ORAL ANDA 25 sections
meloxicam HUMAN PRESCRIPTION DRUG LABEL 1 35356-808 TABLET 7.50 mg ORAL ANDA 25 sections
Vivlodex HUMAN PRESCRIPTION DRUG LABEL 1 42211-205 CAPSULE 5 mg ORAL NDA 28 sections
Vivlodex HUMAN PRESCRIPTION DRUG LABEL 1 42211-206 CAPSULE 10 mg ORAL NDA 28 sections
Meloxicam HUMAN PRESCRIPTION DRUG LABEL 1 42549-519 TABLET 15 mg ORAL ANDA 27 sections
Meloxicam HUMAN PRESCRIPTION DRUG LABEL 1 42549-604 TABLET 7.50 mg ORAL ANDA 27 sections