meloxicam 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | 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 Bocci G, Oprea TI, Benet LZ
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

Predicted pharmacokinetic/toxicological properties (PK-AZ):

PropertyDescriptionValueUnitConfidenceSimilarity
azlogd74 LogD at pH 7.4 0.180 High 1
caco2-efflux Caco-2 efflux ratio (BA/AB) 5.236 High 1
caco2-intrinsic-papp Caco-2 intrinsic apparent permeability 80.168 10^-6 cm/s High 1
dh-clint Dog hepatocyte intrinsic clearance 3.565 uL/min/10^6 cells High 1
dppb Dog plasma protein binding (% unbound) 3.770 % High 1
fcs-ppb Fetal calf serum protein binding (% unbound) 4.240 % High 1
herg hERG pIC50 4.246 pIC50 High 1
hh-clint Human hepatocyte intrinsic clearance 2.704 uL/min/10^6 cells High 1
hlm-clint Human liver microsomal intrinsic clearance 3.048 uL/min/mg protein High 1
hppb Human plasma protein binding (% unbound) 0.530 % High 1
kinase-safety-class ACVR2A,ACVR2B,ALK,AURKA,AURKB,AXL,BRAF,BTK,CAMK2B,CAMK2D,CDK1,CDK14,CDK16,CDK19,CDK2,CDK5,CDK6,CDK7,CDK9,CLK4,CSF1R,DDR1,DYRK1A,DYRK1B,EGFR,EIF2AK3,ERBB2,FLT3,GRK2,GSK3A,GSK3B,IKBKB,IRAK1,IRAK3,ITK,JAK1,JAK2,KIT,MAP3K1,MAP3K10,MAP3K11,MAP3K21,MAP3K7,MAP4K1,MAP4K3,MAPK10,MAPK7,MAPK9,MARK4,MET,MTOR,NTRK1,NTRK2,PDK1,PDK2,PDK4,PIK3CA,PIK3CB,PIK3CD,PIK3CG,PIM2,PRKCD,PRKDC,SIK2,SIK3,STK33,SYK,TEK,TTK,ULK1,ULK2 71
kinase-selectivity-class ACVR2A,ACVR2B,AURKA,AURKB,AURKC,AXL,BRAF,CAMK2D,CDK16,CDK9,CLK4,CSF1R,DDR1,DYRK1B,EPHB4,ERBB2,FLT3,GRK2,GSK3A,GSK3B,IRAK1,JAK1,JAK2,MAP2K3,MAP3K11,MAP3K21,MAP4K1,MAPK1,MAPK12,MAPK7,MARK4,PRKCD,PRKDC,SGK1,SIK2,SIK3,STK17A,STK33,SYK,TEK,TNIK,TTK,ULK1 43
mdck-mdr1-efflux MDCK-MDR1 efflux ratio 14.028 High 1
mh-clint Mouse hepatocyte intrinsic clearance 7.709 High 1
mppb Mouse plasma protein binding (% unbound) 5.030 High 1
nih-mdck-mdr1-efflux NIH MDCK-MDR1 efflux ratio 1.387 High 1
pfas-class PFAS structural alert (1 = True, 0 = False) 0
pld-class Phospholipidosis risk class (1 = positive, 0 = negative) 0 High 1
pppb Pig plasma protein binding (% unbound) 2.240 % High 1
rh-clint Rat hepatocyte intrinsic clearance 5.117 uL/min/10^6 cells High 1
rh-fuinc Rat hepatocyte fraction unbound in incubation 88.190 % High 1
rppb Rat plasma protein binding (% unbound) 0.710 % High 1
solubility-dd Solubility at pH 7.4 in DMSO 674.528 uM High 1

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 312.23 10.38 1305 148329 361309 90117504
Synovial cyst 209.80 10.38 166 149468 11586 90467227
Sciatica 186.04 10.38 473 149161 100909 90377904
Deep vein thrombosis postoperative 180.37 10.38 376 149258 70433 90408380
Febrile neutropenia 175.62 10.38 26 149608 158323 90320490
Ankylosing spondylitis 175.56 10.38 157 149477 12976 90465837
Autoimmune disorder 172.03 10.38 387 149247 76357 90402456
Lower limb fracture 154.27 10.38 395 149239 84618 90394195
Death 152.64 10.38 329 149305 456222 90022591
Neutropenia 152.63 10.38 91 149543 224813 90254000
Spinal column injury 150.80 10.38 73 149561 2092 90476721
Surgical failure 147.71 10.38 57 149577 922 90477891
Musculoskeletal stiffness 144.89 10.38 911 148723 295621 90183192
Road traffic accident 143.29 10.38 447 149187 107179 90371634
Psoriatic arthropathy 140.59 10.38 746 148888 227589 90251224
Anaemia 135.50 10.38 234 149400 352568 90126245
Off label use 130.47 10.38 1179 148455 1101073 89377740
Reversible airways obstruction 129.55 10.38 64 149570 1919 90476894
Vital capacity decreased 128.72 10.38 62 149572 1757 90477056
Bronchitis chronic 127.93 10.38 86 149548 4657 90474156
Musculoskeletal pain 126.31 10.38 589 149045 170662 90308151
Tenosynovitis 123.71 10.38 136 149498 14431 90464382
Fibromyalgia 122.94 10.38 668 148966 205601 90273212
Hypotension 122.06 10.38 219 149415 325178 90153635
Sputum culture positive 116.17 10.38 62 149572 2191 90476622
Liver disorder 115.66 10.38 451 149183 120818 90357995
C-reactive protein 115.39 10.38 195 149439 31172 90447641
C-reactive protein abnormal 112.80 10.38 463 149171 126966 90351847
Crepitations 110.82 10.38 102 149532 8750 90470063
Pulmonary toxicity 107.31 10.38 113 149521 11418 90467395
Tenosynovitis stenosans 105.00 10.38 71 149563 3882 90474931
Grip strength 103.96 10.38 99 149535 8866 90469947
Synovial fluid analysis 103.22 10.38 62 149572 2756 90476057
Pancytopenia 102.90 10.38 35 149599 120228 90358585
Accident 100.69 10.38 87 149547 6867 90471946
Acute kidney injury 96.45 10.38 244 149390 320143 90158670
Porphyria acute 94.71 10.38 132 149502 17843 90460970
Bursitis 93.54 10.38 448 149186 131206 90347607
Cardiac failure 91.73 10.38 33 149601 109463 90369350
Allergy to chemicals 91.63 10.38 64 149570 3690 90475123
Bronchial secretion retention 91.45 10.38 63 149571 3552 90475261
Arthralgia 91.37 10.38 1797 147837 776725 89702088
Dry mouth 90.75 10.38 567 149067 183492 90295321
Drug hypersensitivity 90.72 10.38 1166 148468 462443 90016370
Joint range of motion decreased 88.84 10.38 451 149183 135192 90343621
Disease progression 88.41 10.38 77 149557 156538 90322275
Visual impairment 88.02 10.38 442 149192 131923 90346890
X-ray abnormal 87.55 10.38 216 149418 45208 90433605
Malignant neoplasm progression 84.90 10.38 35 149599 106835 90371978
Bone density decreased 82.04 10.38 121 149513 17224 90461589
Scleritis 81.23 10.38 68 149566 5140 90473673
Swollen joint count increased 80.87 10.38 381 149253 110825 90367988
Lupus vulgaris 77.24 10.38 205 149429 44854 90433959
Toxicity to various agents 77.08 10.38 232 149402 287614 90191199
Blood folate decreased 75.15 10.38 42 149592 1628 90477185
Septic shock 72.85 10.38 24 149610 84136 90394677
Lung disorder 72.80 10.38 460 149174 149423 90329390
Myelosuppression 72.12 10.38 4 149630 53587 90425226
Exposure during pregnancy 69.85 10.38 184 149450 238226 90240587
Product dose omission issue 69.50 10.38 762 148872 290925 90187888
Mobility decreased 68.72 10.38 674 148960 250060 90228753
Asthma 68.36 10.38 655 148979 241505 90237308
Peripheral swelling 68.14 10.38 1008 148626 412098 90066715
Arthritis 67.80 10.38 491 149143 166824 90311989
Lip dry 67.02 10.38 337 149297 100618 90378195
Pleural effusion 67.00 10.38 52 149582 111939 90366874
Dry eye 66.64 10.38 229 149405 57702 90421111
Antinuclear antibody positive 66.18 10.38 79 149555 9162 90469651
Respiratory failure 63.53 10.38 61 149573 118357 90360456
Blood cholesterol increased 63.41 10.38 572 149062 207440 90271373
Linear IgA disease 63.18 10.38 42 149592 2232 90476581
Osteoarthritis 63.16 10.38 545 149089 195185 90283628
Thrombocytopenia 61.97 10.38 160 149474 208565 90270248
Rheumatoid lung 60.76 10.38 52 149582 4051 90474762
Psoriasis 60.67 10.38 435 149199 147319 90331494
Photophobia 58.95 10.38 117 149517 21152 90457661
Swollen joint count 58.75 10.38 72 149562 8581 90470232
Gait disturbance 58.62 10.38 673 148961 259823 90218990
Blood creatinine increased 58.24 10.38 49 149585 101337 90377476
Infection 57.15 10.38 877 148757 361217 90117596
Sleep disorder due to a general medical condition 55.13 10.38 181 149453 44557 90434256
Hypoaesthesia 55.07 10.38 775 148859 313435 90165378
Neck surgery 54.88 10.38 37 149597 2013 90476800
Anxiety 54.27 10.38 764 148870 309008 90169805
Adjustment disorder with depressed mood 54.02 10.38 211 149423 56542 90422271
Rheumatic fever 52.91 10.38 433 149201 152688 90326125
Rash pruritic 52.86 10.38 272 149362 81942 90396871
Pain in extremity 52.69 10.38 1040 148594 449489 90029324
Drug interaction 51.96 10.38 257 149377 276196 90202617
Sepsis 51.73 10.38 140 149494 179674 90299139
Impaired work ability 50.80 10.38 104 149530 19222 90459591
Cushingoid 49.86 10.38 73 149561 10322 90468491
Abortion spontaneous 49.34 10.38 14 149620 54042 90424771
Hyperkalaemia 48.87 10.38 23 149611 64941 90413872
Joint swelling 48.30 10.38 1129 148505 502171 89976642
Knee arthroplasty 47.90 10.38 267 149367 82915 90395898
Upper-airway cough syndrome 47.79 10.38 88 149546 15047 90463766
Rheumatoid factor positive 47.78 10.38 463 149171 171187 90307626
Night sweats 47.14 10.38 369 149265 128397 90350416
Feeling jittery 46.81 10.38 88 149546 15283 90463530
Pleuritic pain 46.65 10.38 71 149563 10390 90468423
Muscular weakness 46.51 10.38 534 149100 206132 90272681
Pyrexia 46.14 10.38 790 148844 659695 89819118
Neck pain 45.32 10.38 333 149301 113630 90365183
Viral upper respiratory tract infection 44.88 10.38 63 149571 8571 90470242
Joint effusion 43.70 10.38 99 149535 19611 90459202
Loss of personal independence in daily activities 43.37 10.38 378 149256 135727 90343086
Multiple allergies 42.80 10.38 84 149550 15062 90463751
Laboratory test abnormal 41.79 10.38 158 149476 41696 90437117
Listless 41.77 10.38 38 149596 3211 90475602
Hyponatraemia 41.47 10.38 100 149534 133438 90345375
Drug abuse 41.23 10.38 45 149589 82302 90396511
Contusion 40.97 10.38 612 149022 250604 90228209
Pulmonary mass 40.59 10.38 122 149512 28650 90450163
Agranulocytosis 40.56 10.38 5 149629 34997 90443816
Neutrophil count decreased 40.56 10.38 35 149599 71497 90407316
Breast cancer 40.39 10.38 186 149448 53575 90425238
Grip strength decreased 40.00 10.38 276 149358 92300 90386513
Tenderness 39.88 10.38 116 149518 26752 90452061
Flank pain 39.82 10.38 94 149540 19128 90459685
Hepatitis 39.64 10.38 35 149599 70704 90408109
Rheumatoid nodule 38.97 10.38 96 149538 20070 90458743
Alanine aminotransferase increased 38.85 10.38 86 149548 118252 90360561
Hepatic function abnormal 38.68 10.38 14 149620 46274 90432539
Nodule 38.45 10.38 114 149520 26572 90452241
Oedema 38.33 10.38 502 149132 199793 90279020
Ear infection 38.21 10.38 221 149413 69554 90409259
Sedation 37.89 10.38 16 149618 48155 90430658
Foetal exposure during pregnancy 37.64 10.38 12 149622 42963 90435850
Delirium 37.61 10.38 298 149336 104061 90374752
Aspartate aminotransferase increased 37.02 10.38 71 149563 102866 90375947
Electrocardiogram QT prolonged 36.94 10.38 39 149595 72417 90406396
Multiple organ dysfunction syndrome 36.88 10.38 35 149599 68301 90410512
Liver injury 36.71 10.38 437 149197 170130 90308683
Retinitis 36.61 10.38 143 149491 38315 90440498
White blood cell count increased 36.19 10.38 212 149422 67029 90411784
Wheezing 35.76 10.38 572 149062 237508 90241305
Corneal reflex decreased 35.68 10.38 15 149619 306 90478507
Laryngitis 35.51 10.38 172 149462 50581 90428232
Dislocation of vertebra 35.16 10.38 184 149450 55784 90423029
Cerebrovascular accident 34.91 10.38 97 149537 123436 90355377
Eye irritation 34.53 10.38 129 149505 33849 90444964
Overdose 34.19 10.38 139 149495 157570 90321243
Colitis 34.16 10.38 39 149595 69903 90408910
Renal failure 34.03 10.38 107 149527 130900 90347913
Intestinal diaphragm disease 33.98 10.38 12 149622 149 90478664
Pulmonary embolism 33.87 10.38 107 149527 130713 90348100
Maternal exposure during pregnancy 33.78 10.38 406 149228 359657 90119156
Surgery 33.50 10.38 155 149479 44732 90434081
Malaise 33.24 10.38 1231 148403 584755 89894058
Pneumonia aspiration 33.17 10.38 13 149621 40927 90437886
Memory impairment 33.12 10.38 483 149151 196761 90282052
Cardiac failure congestive 33.00 10.38 71 149563 98623 90380190
Exostosis 32.91 10.38 174 149460 52960 90425853
Eosinophil count increased 32.75 10.38 69 149565 13012 90465801
Bradycardia 32.69 10.38 55 149579 83792 90395021
Deformity 32.59 10.38 66 149568 12104 90466709
Peripheral venous disease 32.10 10.38 243 149391 83678 90395135
Pulmonary hypertension 32.07 10.38 15 149619 42508 90436305
Foot deformity 32.06 10.38 188 149446 59463 90419350
Therapy non-responder 31.99 10.38 356 149278 136348 90342465
Somatic delusion 31.95 10.38 17 149617 597 90478216
Suicide attempt 31.73 10.38 47 149587 75352 90403461
Hypoxia 31.58 10.38 44 149590 72355 90406458
Sinusitis 31.45 10.38 765 148869 342323 90136490
Dehydration 31.44 10.38 190 149444 194257 90284556
Injection site pain 31.02 10.38 430 149204 173269 90305544
Hypercalcaemia 31.00 10.38 9 149625 34231 90444582
Sleep disorder due to general medical condition, insomnia type 30.97 10.38 337 149297 128357 90350456
Respiratory disorder 30.87 10.38 198 149436 64618 90414195
Amnesia 30.83 10.38 294 149340 108211 90370602
Syncope 30.63 10.38 114 149520 132549 90346264
Premature baby 30.54 10.38 3 149631 25074 90453739
Mucosal inflammation 30.53 10.38 30 149604 57595 90421218
Bone erosion 30.39 10.38 170 149464 52851 90425962
Blood pressure decreased 30.25 10.38 48 149586 74847 90403966
Conjunctivitis 30.21 10.38 105 149529 26601 90452212
Hepatic cytolysis 30.14 10.38 7 149627 30909 90447904
Platelet count decreased 30.14 10.38 120 149514 136849 90341964
Intentional self-injury 29.91 10.38 6 149628 29328 90449485
Walking aid user 29.82 10.38 127 149507 35379 90443434
Seizure 29.75 10.38 140 149494 152489 90326324
International normalised ratio increased 29.54 10.38 21 149613 47295 90431518
Hepatocellular injury 29.36 10.38 6 149628 28952 90449861
Reduced facial expression 29.24 10.38 28 149606 2525 90476288
Respiratory distress 28.97 10.38 14 149620 38932 90439881
Eosinophilia 28.75 10.38 6 149628 28527 90450286
Back pain 28.70 10.38 706 148928 316469 90162344
Sputum culture 28.63 10.38 13 149621 321 90478492
Drug tolerance decreased 28.61 10.38 117 149517 32013 90446800
Orthostatic hypotension 28.24 10.38 17 149617 41810 90437003
Muscle spasms 28.23 10.38 578 149056 251305 90227508
Hip arthroplasty 28.22 10.38 219 149415 75989 90402824
Clostridium difficile colitis 28.21 10.38 5 149629 26701 90452112
Cytomegalovirus infection 28.06 10.38 5 149629 26597 90452216
Rhabdomyolysis 27.96 10.38 26 149608 51230 90427583
Abdominal pain upper 27.90 10.38 733 148901 331941 90146872
Pseudoporphyria 27.46 10.38 12 149622 270 90478543
Hypokalaemia 26.91 10.38 118 149516 130998 90347815
Acute hepatic failure 26.70 10.38 3 149631 22558 90456255
Prescribed overdose 26.50 10.38 262 149372 97363 90381450
Food allergy 26.42 10.38 5 149629 25473 90453340
Spinal cord infection 26.40 10.38 16 149618 723 90478090
Posterior reversible encephalopathy syndrome 26.36 10.38 3 149631 22336 90456477
Lupus-like syndrome 26.28 10.38 154 149480 48692 90430121
Macular degeneration 26.25 10.38 15 149619 37955 90440858
Pregnancy 26.22 10.38 184 149450 61863 90416950
Gait inability 25.92 10.38 362 149272 146094 90332719
Ejection fraction decreased 25.49 10.38 6 149628 26247 90452566
Haematuria 25.32 10.38 13 149621 34924 90443889
Weight fluctuation 25.32 10.38 81 149553 19668 90459145
Metastases to liver 25.31 10.38 8 149626 28799 90450014
Discomfort 25.22 10.38 612 149022 273723 90205090
Maternal exposure timing unspecified 25.09 10.38 88 149546 22395 90456418
Blood bilirubin increased 24.97 10.38 21 149613 43449 90435364
Live birth 24.83 10.38 219 149415 78888 90399925
Ischaemic gastritis 24.70 10.38 5 149629 3 90478810
Synovial disorder 24.57 10.38 28 149606 3090 90475723
Epilepsy 24.39 10.38 63 149571 82143 90396670
Sleep disorder 24.06 10.38 460 149174 197570 90281243
Ocular hyperaemia 23.97 10.38 115 149519 33683 90445130
Altered state of consciousness 23.97 10.38 11 149623 31521 90447292
Myocardial infarction 23.85 10.38 92 149542 105880 90372933
Head discomfort 23.75 10.38 70 149564 16263 90462550
Pre-existing condition improved 23.70 10.38 49 149585 9120 90469693
Breast cancer stage III 23.58 10.38 228 149406 84219 90394594
Atrial fibrillation 23.51 10.38 127 149507 133484 90345329
Tachycardia 23.47 10.38 158 149476 157515 90321298
Pneumonitis 23.40 10.38 23 149611 44147 90434666
Cerebral haemorrhage 23.35 10.38 14 149620 34508 90444305
Hyperglycaemia 23.22 10.38 30 149604 50940 90427873
Injury 23.15 10.38 456 149178 196893 90281920
Intentional overdose 22.74 10.38 79 149555 93755 90385058
Hypoglycaemia 22.73 10.38 51 149583 69797 90409016
Spinal operation 22.37 10.38 51 149583 10145 90468668
Constipation 22.33 10.38 327 149307 280068 90198745
Eye pain 22.32 10.38 137 149497 44031 90434782
Cerebral infarction 22.29 10.38 8 149626 26588 90452225
Condition aggravated 22.26 10.38 1199 148435 594346 89884467
Gamma-glutamyltransferase increased 22.22 10.38 18 149616 37934 90440879
Depression 22.01 10.38 651 148983 299950 90178863
Bone marrow failure 21.89 10.38 13 149621 32208 90446605
Ascites 21.85 10.38 28 149606 47712 90431101
Atelectasis 21.82 10.38 89 149545 24320 90454493
Acute myeloid leukaemia 21.51 10.38 4 149630 20636 90458177
Type 2 diabetes mellitus 21.34 10.38 462 149172 202782 90276031
Red blood cell sedimentation rate decreased 21.32 10.38 16 149618 1032 90477781
Hypermobility syndrome 21.26 10.38 15 149619 879 90477934
Angina pectoris 21.20 10.38 20 149614 39140 90439673
Creatinine renal clearance decreased 21.18 10.38 3 149631 18896 90459917
Pulmonary fibrosis 20.78 10.38 270 149364 107233 90371580
Fall 20.57 10.38 622 149012 481188 89997625
Chest discomfort 20.42 10.38 139 149495 138226 90340587
Chronic sinusitis 20.23 10.38 7 149627 23795 90455018
Pulmonary arterial hypertension 20.12 10.38 9 149625 26178 90452635
HLA marker study positive 20.02 10.38 9 149625 217 90478596
Lymphomatoid papulosis 19.90 10.38 8 149626 145 90478668
Oesophageal mucosal tear 19.89 10.38 5 149629 16 90478797
Feeling abnormal 19.81 10.38 387 149247 166848 90311965
Angioedema 19.80 10.38 49 149585 64827 90413986
Haematochezia 19.79 10.38 56 149578 70857 90407956
Drug intolerance 19.79 10.38 916 148718 446675 90032138
Device expulsion 19.75 10.38 23 149611 40863 90437950
Dysphoria 19.70 10.38 36 149598 6118 90472695
Foetal death 19.60 10.38 5 149629 20718 90458095
Hepatic failure 19.57 10.38 22 149612 39706 90439107
Coeliac disease 19.57 10.38 27 149607 44583 90434230
Palmar-plantar erythrodysaesthesia syndrome 19.47 10.38 11 149623 28012 90450801
Hypocalcaemia 19.24 10.38 25 149609 42343 90436470
Coma 19.09 10.38 59 149575 72573 90406240
Neoplasm malignant 19.00 10.38 108 149526 33772 90445041
Ulcer haemorrhage 18.99 10.38 90 149544 26231 90452582
Dermatitis atopic 18.97 10.38 83 149551 23389 90455424
Bezoar 18.97 10.38 23 149611 2711 90476102
Poliomyelitis 18.92 10.38 6 149628 52 90478761
Wound infection 18.83 10.38 263 149371 106139 90372674
Pemphigus 18.76 10.38 404 149230 326460 90152353
Coordination abnormal 18.64 10.38 6 149628 21350 90457463
Product administration interrupted 18.60 10.38 54 149580 12438 90466375
Anaphylactic shock 18.50 10.38 15 149619 31602 90447211
Neoplasm progression 18.45 10.38 28 149606 44458 90434355
Injection site swelling 18.44 10.38 165 149469 59674 90419139
Blister 18.33 10.38 551 149083 254447 90224366
Bacteraemia 18.20 10.38 7 149627 22293 90456520
Drug eruption 18.11 10.38 19 149615 35388 90443425
Dyspnoea exertional 18.10 10.38 60 149574 72228 90406585
Injection site vesicles 18.02 10.38 28 149606 4172 90474641
Intervertebral disc degeneration 17.90 10.38 66 149568 17208 90461605
Small intestinal ulcer haemorrhage 17.90 10.38 6 149628 63 90478750
Neutropenic sepsis 17.89 10.38 4 149630 18126 90460687
Transaminases increased 17.88 10.38 21 149613 37171 90441642
Gastric ulcer 17.77 10.38 91 149543 27357 90451456
Nodular rash 17.53 10.38 8 149626 200 90478613
Hemiparesis 17.52 10.38 16 149618 31803 90447010
Foreign body 17.33 10.38 21 149613 2473 90476340
Pancreatitis 17.32 10.38 184 149450 69642 90409171
Pneumocystis jirovecii pneumonia 17.29 10.38 7 149627 21609 90457204
Joint stiffness 17.24 10.38 201 149433 77841 90400972
Disseminated intravascular coagulation 17.19 10.38 7 149627 21531 90457282
Hemiplegia 17.13 10.38 3 149631 16157 90462656
Arthropathy 16.93 10.38 753 148881 365489 90113324
Mitral valve incompetence 16.90 10.38 8 149626 22516 90456297
Obesity 16.78 10.38 256 149378 105251 90373562
Anti-cyclic citrullinated peptide antibody 16.76 10.38 89 149545 27132 90451681
Deep vein thrombosis 16.72 10.38 86 149548 91534 90387279
Ear pain 16.71 10.38 157 149477 57545 90421268
Depressed level of consciousness 16.50 10.38 63 149571 72721 90406092
Eyelid retraction 16.47 10.38 6 149628 82 90478731
Dysphagia 16.46 10.38 113 149521 112165 90366648
Proteinuria 16.39 10.38 9 149625 23282 90455531
Fixed eruption 16.18 10.38 17 149617 1713 90477100
Hypomagnesaemia 16.16 10.38 21 149613 35567 90443246
Red blood cell sedimentation rate abnormal 16.11 10.38 10 149624 24194 90454619
Dystonia 16.02 10.38 4 149630 16815 90461998
Jaundice 16.02 10.38 18 149616 32499 90446314
Onychomycosis 16.02 10.38 23 149611 37353 90441460
Ulcer 16.00 10.38 101 149533 32781 90446032
Blood alkaline phosphatase increased 15.73 10.38 35 149599 48044 90430769
Dyspnoea 15.71 10.38 1247 148387 879708 89599105
Neuroleptic malignant syndrome 15.57 10.38 3 149631 15093 90463720
Therapeutic response decreased 15.55 10.38 221 149413 89508 90389305
Gastric mucosal hypertrophy 15.55 10.38 6 149628 97 90478716
Feeling hot 15.53 10.38 197 149437 77811 90401002
Onychomadesis 15.45 10.38 33 149601 45965 90432848
Product dose omission in error 15.45 10.38 71 149563 20432 90458381
Nasal mucosal discolouration 15.41 10.38 5 149629 47 90478766
Fluid retention 15.34 10.38 84 149550 88007 90390806
Schizophrenia 15.31 10.38 3 149631 14911 90463902
Pruritus 15.31 10.38 1064 148570 540461 89938352
Carpal tunnel syndrome 15.26 10.38 79 149555 23849 90454964
Pulmonary oedema 15.22 10.38 52 149582 62028 90416785
Abdominal distension 15.18 10.38 140 149494 130461 90348352
Anuria 15.17 10.38 3 149631 14815 90463998
Metastases to bone 15.05 10.38 12 149622 25493 90453320
Face oedema 15.02 10.38 10 149624 23308 90455505
Trigger finger 15.00 10.38 29 149605 5141 90473672
Treatment failure 14.96 10.38 629 149005 303299 90175514
Haemorrhagic diathesis 14.84 10.38 30 149604 5494 90473319
Product use issue 14.79 10.38 423 149211 329496 90149317
Accidental overdose 14.66 10.38 15 149619 28258 90450555
Blood calcium decreased 14.55 10.38 17 149617 30165 90448648
Duodenal ulcer perforation 14.53 10.38 473 149161 220815 90257998
Pancreatitis acute 14.53 10.38 19 149615 32096 90446717
Blood creatine phosphokinase increased 14.52 10.38 21 149613 34002 90444811
Lymphopenia 14.49 10.38 10 149624 22871 90455942
Leukopenia 14.45 10.38 102 149532 100608 90378205
Muscle rigidity 14.44 10.38 3 149631 14306 90464507
Pulmonary congestion 14.43 10.38 7 149627 19426 90459387
Progressive multifocal leukoencephalopathy 14.39 10.38 4 149630 15651 90463162
Prescription drug used without a prescription 14.38 10.38 22 149612 3233 90475580
Skin necrosis 14.36 10.38 5 149629 16936 90461877
Respiratory tract infection 14.34 10.38 155 149479 58923 90419890
Frequent bowel movements 14.11 10.38 150 149484 56785 90422028
Tendon injury 14.10 10.38 18 149616 2235 90476578
Drug ineffective 13.99 10.38 2541 147093 1381757 89097056
Conjunctival bleb 13.95 10.38 5 149629 65 90478748
Generalised oedema 13.94 10.38 7 149627 19046 90459767
Muscle spasticity 13.92 10.38 23 149611 35299 90443514
Sacroiliitis 13.91 10.38 25 149609 4194 90474619
Hepatic enzyme decreased 13.90 10.38 12 149622 946 90477867
Pupillary reflex impaired 13.87 10.38 19 149615 2526 90476287
Proctitis 13.83 10.38 4 149630 15255 90463558
Ischaemic stroke 13.63 10.38 10 149624 22156 90456657
Renal impairment 13.59 10.38 110 149524 105311 90373502
Migraine 13.56 10.38 411 149223 189981 90288832
Myelodysplastic syndrome 13.42 10.38 9 149625 20894 90457919
Knee operation 13.38 10.38 33 149601 6903 90471910
Tender joint count 13.35 10.38 14 149620 1407 90477406
Drug reaction with eosinophilia and systemic symptoms 13.28 10.38 32 149602 42726 90436087
Thalassaemia minor 13.24 10.38 4 149630 29 90478784
Oral candidiasis 13.14 10.38 24 149610 35431 90443382
Decreased gait velocity 13.12 10.38 4 149630 30 90478783
Inappropriate antidiuretic hormone secretion 13.07 10.38 8 149626 19497 90459316
Nephrolithiasis 12.96 10.38 131 149503 48954 90429859
Disorientation 12.94 10.38 34 149600 44080 90434733
Obstructive airways disorder 12.92 10.38 80 149554 25789 90453024
Aggression 12.88 10.38 15 149619 26653 90452160
Cardiac arrest 12.85 10.38 111 149523 104824 90373989
Myofascial pain syndrome 12.83 10.38 20 149614 2987 90475826
Epistaxis 12.81 10.38 85 149549 85040 90393773
Breast cancer stage II 12.78 10.38 101 149533 35233 90443580
Kyphoscoliosis 12.78 10.38 9 149625 526 90478287
Colitis ulcerative 12.77 10.38 154 149480 60112 90418701
Paraesthesia 12.76 10.38 520 149114 249806 90229007
Sinus bradycardia 12.75 10.38 6 149628 16946 90461867
Hepatic cirrhosis 12.70 10.38 160 149474 63093 90415720
Product use in unapproved indication 12.68 10.38 441 149193 335795 90143018
Limb asymmetry 12.62 10.38 11 149623 878 90477935
Meralgia paraesthetica 12.60 10.38 9 149625 538 90478275
Musculoskeletal discomfort 12.49 10.38 68 149566 20923 90457890
Muscle injury 12.49 10.38 381 149253 176273 90302540
Subarachnoid haemorrhage 12.48 10.38 7 149627 17897 90460916
Urine odour abnormal 12.45 10.38 33 149601 7211 90471602
Splenomegaly 12.45 10.38 3 149631 12921 90465892
Enthesopathy 12.45 10.38 39 149595 9365 90469448
Therapy interrupted 12.41 10.38 132 149502 49976 90428837
Gangrene 12.39 10.38 3 149631 12873 90465940
Status epilepticus 12.29 10.38 8 149626 18866 90459947
Hepatotoxicity 12.21 10.38 37 149597 45805 90433008
Parkinsonism 12.19 10.38 4 149630 14061 90464752
Injection site bruising 12.13 10.38 136 149498 52171 90426642
Facet joint syndrome 12.09 10.38 229 149405 98160 90380653
Parotid gland enlargement 12.06 10.38 11 149623 932 90477881
Sleep disorder due to general medical condition, hypersomnia type 12.06 10.38 16 149618 2063 90476750
Circulatory collapse 12.04 10.38 14 149620 24890 90453923
Anhidrosis 11.96 10.38 6 149628 186 90478627
Vertigo 11.72 10.38 171 149463 69640 90409173
Early satiety 11.71 10.38 13 149621 1394 90477419
Acute generalised exanthematous pustulosis 11.70 10.38 4 149630 13699 90465114
Rash maculo-papular 11.66 10.38 111 149523 40822 90437991
Purpura senile 11.65 10.38 9 149625 606 90478207
Apallic syndrome 11.61 10.38 10 149624 786 90478027
Chest pain 11.60 10.38 642 148992 319003 90159810
Therapeutic product effect decreased 11.60 10.38 565 149069 277006 90201807
Therapy cessation 11.58 10.38 101 149533 36260 90442553
Diabetic ketoacidosis 11.50 10.38 14 149620 24393 90454420
Haematemesis 11.49 10.38 24 149610 33702 90445111
Myopathy 11.44 10.38 4 149630 13514 90465299
Jaundice neonatal 11.42 10.38 11 149623 999 90477814
Pelvic adhesions 11.34 10.38 7 149627 327 90478486
Eye injury 11.33 10.38 42 149592 10978 90467835
Eating disorder 11.33 10.38 18 149616 28055 90450758
Appetite disorder 11.29 10.38 37 149597 9096 90469717
Body temperature increased 11.27 10.38 37 149597 44673 90434140
Areflexia 11.23 10.38 21 149613 3632 90475181
Gastrooesophageal reflux disease 11.23 10.38 200 149434 166137 90312676
Cytokine release syndrome 11.23 10.38 18 149616 27955 90450858
Skin warm 11.23 10.38 33 149601 7654 90471159
Stress cardiomyopathy 11.22 10.38 4 149630 13351 90465462
Thrombotic microangiopathy 11.20 10.38 6 149628 15737 90463076
Quality of life decreased 11.15 10.38 44 149590 11845 90466968
Dandruff 11.13 10.38 7 149627 338 90478475
Dysstasia 11 10.38 75 149559 24977 90453836
Demyelination 11.00 10.38 34 149600 8106 90470707
Product label confusion 10.88 10.38 13 149621 22837 90455976
Intentional dose omission 10.85 10.38 58 149576 17725 90461088
Plasma cell myeloma 10.84 10.38 33 149601 40795 90438018
Ventricular tachycardia 10.79 10.38 15 149619 24693 90454120
Manipulation 10.76 10.38 4 149630 58 90478755
Diabetes mellitus inadequate control 10.76 10.38 9 149625 18675 90460138
Central nervous system stimulation 10.70 10.38 4 149630 59 90478754
Arrhythmia 10.69 10.38 35 149599 42297 90436516
Metastases to central nervous system 10.67 10.38 8 149626 17534 90461279
Rectal haemorrhage 10.66 10.38 194 149440 82550 90396263
Gastroenteritis 10.65 10.38 20 149614 29209 90449604
Hypervolaemia 10.59 10.38 24 149610 32733 90446080
Coronary artery disease 10.57 10.38 25 149609 33598 90445215
Decreased eye contact 10.56 10.38 7 149627 370 90478443
Oxygen saturation decreased 10.52 10.38 120 149514 107363 90371450
Heart rate decreased 10.47 10.38 49 149585 53456 90425357
Cyanosis 10.45 10.38 10 149624 19445 90459368

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 246.09 12.89 224 27613 48380 42545118
Arthralgia 144.84 12.89 374 27463 204864 42388634
Psoriatic arthropathy 142.05 12.89 123 27714 24844 42568654
Joint swelling 98.83 12.89 167 27670 67855 42525643
Pain 87.90 12.89 354 27483 244494 42349004
Gastric haemorrhage 85.78 12.89 64 27773 10451 42583047
Lipoma 69.63 12.89 32 27805 2106 42591392
Ankylosing spondylitis 69.12 12.89 48 27789 7008 42586490
Seronegative arthritis 68.84 12.89 27 27810 1197 42592301
Back pain 59.83 12.89 216 27621 141560 42451938
Musculoskeletal stiffness 59.04 12.89 122 27715 57643 42535855
Off label use 55.06 12.89 223 27614 638112 41955386
Pain in extremity 51.73 12.89 215 27622 150389 42443109
Product dose omission issue 48.88 12.89 215 27622 154150 42439348
Drug ineffective 48.50 12.89 625 27212 629572 41963926
Febrile neutropenia 46.79 12.89 32 27805 185671 42407827
Osteoarthritis 46.64 12.89 68 27769 24337 42569161
Intestinal diaphragm disease 45.38 12.89 14 27823 299 42593199
Neutropenia 43.18 12.89 40 27797 199391 42394107
Arthritis 41.98 12.89 88 27749 41977 42551521
Thrombocytopenia 40.21 12.89 39 27798 190240 42403258
Surgery 39.49 12.89 53 27784 17563 42575935
Xyphoid retraction 39.48 12.89 11 27826 162 42593336
Prostatic pain 39.44 12.89 13 27824 346 42593152
Musculoskeletal discomfort 39.00 12.89 39 27798 9437 42584061
Exostosis 36.66 12.89 30 27807 5601 42587897
Gastrointestinal haemorrhage 34.69 12.89 141 27696 97585 42495913
Duodenal ulcer 33.94 12.89 41 27796 12238 42581260
Inflammatory marker increased 33.86 12.89 31 27806 6725 42586773
Disease progression 33.27 12.89 27 27810 143629 42449869
Multiple organ dysfunction syndrome 33.16 12.89 11 27826 97024 42496474
Neck pain 32.56 12.89 65 27772 29949 42563549
Fatigue 32.07 12.89 429 27408 435212 42158286
Sinusitis 31.99 12.89 85 27752 47207 42546291
Completed suicide 31.75 12.89 136 27701 96329 42497169
Peripheral swelling 31.05 12.89 129 27708 90141 42503357
Oropharyngeal pain 30.38 12.89 78 27759 42432 42551066
Hip arthroplasty 29.88 12.89 26 27811 5279 42588219
Knee arthroplasty 28.76 12.89 32 27805 8749 42584749
Arthropathy 28.46 12.89 61 27776 29536 42563962
Gastric ulcer 28.04 12.89 46 27791 18216 42575282
Oesophageal infection 27.99 12.89 10 27827 341 42593157
Ankle fracture 27.71 12.89 24 27813 4842 42588656
Rheumatoid arthritis 27.41 12.89 75 27762 42365 42551133
Dermatitis atopic 27.32 12.89 37 27800 12367 42581131
Foot deformity 26.86 12.89 24 27813 5044 42588454
Mobility decreased 26.50 12.89 66 27771 35240 42558258
Foot fracture 26.44 12.89 26 27811 6165 42587333
Pruritus 26.35 12.89 212 27625 188559 42404939
Joint stiffness 25.99 12.89 36 27801 12286 42581212
Injection site erythema 25.93 12.89 47 27790 20148 42573350
Hernia 25.87 12.89 34 27803 11039 42582459
General physical health deterioration 25.52 12.89 37 27800 151209 42442289
Neck surgery 24.20 12.89 10 27827 508 42592990
Tendon disorder 24.07 12.89 19 27818 3370 42590128
Prostatic specific antigen increased 23.81 12.89 41 27796 16884 42576614
Arthrofibrosis 23.66 12.89 6 27831 60 42593438
Headache 22.46 12.89 247 27590 239122 42354376
Insomnia 22.40 12.89 143 27694 118110 42475388
Ascites 22.03 12.89 5 27832 56673 42536825
Leukopenia 21.45 12.89 11 27826 74735 42518763
Feeling abnormal 19.66 12.89 94 27743 69692 42523806
Duodenal ulcer perforation 19.58 12.89 13 27824 1763 42591735
Acute generalised exanthematous pustulosis 19.48 12.89 26 27811 8569 42584929
Cytokine release syndrome 19.28 12.89 3 27834 44524 42548974
Pyrexia 19.17 12.89 165 27672 393877 42199621
Injection site bruising 19.02 12.89 30 27807 11495 42582003
Platelet count decreased 18.72 12.89 39 27798 138542 42454956
Pancytopenia 18.70 12.89 30 27807 117713 42475785
Drug hypersensitivity 18.70 12.89 120 27717 99269 42494229
Spinal operation 18.54 12.89 18 27819 4202 42589296
Rash 18.38 12.89 268 27569 276686 42316812
Finger deformity 18.10 12.89 12 27825 1623 42591875
Fixed eruption 17.95 12.89 14 27823 2440 42591058
Gait disturbance 17.63 12.89 117 27720 97883 42495615
Hepatic function abnormal 17.34 12.89 6 27831 51561 42541937
Skin exfoliation 17.22 12.89 63 27774 41490 42552008
Epstein Barr virus positive mucocutaneous ulcer 16.82 12.89 8 27829 569 42592929
Cartilage injury 16.54 12.89 8 27829 591 42592907
Injection site pain 16.39 12.89 78 27759 57720 42535778
Hypoxia 16.29 12.89 13 27824 69773 42523725
Intervertebral disc degeneration 16.26 12.89 22 27815 7345 42586153
Blister 16.20 12.89 47 27790 27443 42566055
Therapy cessation 16.16 12.89 39 27798 20411 42573087
Therapeutic product effect incomplete 16.12 12.89 90 27747 70849 42522649
Water intoxication 15.95 12.89 7 27830 413 42593085
Back disorder 15.92 12.89 22 27815 7492 42586006
Ileal ulcer 15.75 12.89 9 27828 935 42592563
Pharyngeal lesion 15.71 12.89 3 27834 6 42593492
Loose body in joint 15.51 12.89 4 27833 43 42593455
Anaemia 15.15 12.89 114 27723 280164 42313334
Uveitis 15.14 12.89 24 27813 9234 42584264
Gastric perforation 15.13 12.89 14 27823 3079 42590419
Cellulitis gangrenous 15.11 12.89 6 27831 275 42593223
Nasopharyngitis 14.94 12.89 100 27737 83896 42509602
Gastrointestinal mucosal exfoliation 14.93 12.89 5 27832 140 42593358
Septic shock 14.89 12.89 23 27814 91649 42501849
Iritis 14.87 12.89 11 27826 1771 42591727
Discomfort 14.75 12.89 43 27794 25176 42568322
Acanthosis 14.51 12.89 5 27832 153 42593345
Skin ulcer 14.35 12.89 43 27794 25558 42567940
Limb injury 14.35 12.89 30 27807 14275 42579223
Intentional dose omission 14.29 12.89 23 27814 8963 42584535
Malignant neoplasm progression 14.23 12.89 31 27806 108369 42485129
Fibromyalgia 14.10 12.89 15 27822 3898 42589600
Lumbar radiculopathy 14.03 12.89 8 27829 827 42592671
Mycobacterium tuberculosis complex test positive 14.00 12.89 10 27827 1526 42591972
Hypoaesthesia 13.88 12.89 87 27750 71376 42522122
Blood pressure systolic increased 13.85 12.89 45 27792 27923 42565575
Electrocardiogram QRS complex prolonged 13.79 12.89 18 27819 5805 42587693
Cardiac failure 13.66 12.89 31 27806 106825 42486673
Dry skin 13.53 12.89 65 27772 48273 42545225
Therapeutic product effect decreased 13.49 12.89 56 27781 39094 42554404
Injection site haemorrhage 13.43 12.89 26 27811 11710 42581788
Dizziness 13.43 12.89 233 27604 249021 42344477
Neutrophil count decreased 13.37 12.89 13 27824 63402 42530096
Muscle spasms 13.29 12.89 99 27738 85945 42507553
Mucosal inflammation 13.11 12.89 8 27829 49366 42544132
Synovial cyst 13.05 12.89 12 27825 2617 42590881
Abdominal discomfort 13.02 12.89 89 27748 75166 42518332
Prostatomegaly 12.96 12.89 18 27819 6159 42587339
Rotator cuff repair 12.91 12.89 6 27831 405 42593093

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 392.65 11.21 1090 149069 298523 110140617
Febrile neutropenia 266.62 11.21 53 150106 316714 110122426
Deep vein thrombosis postoperative 262.97 11.21 362 149797 58929 110380211
Psoriatic arthropathy 260.66 11.21 719 149440 196042 110243098
Autoimmune disorder 256.80 11.21 377 149782 65106 110374034
Sciatica 255.71 11.21 454 149705 91945 110347195
Neutropenia 248.19 11.21 99 150060 374521 110064619
Lower limb fracture 226.47 11.21 384 149775 74964 110364176
Musculoskeletal stiffness 224.08 11.21 861 149298 278961 110160179
Off label use 206.50 11.21 1196 148963 1498989 108940151
Fibromyalgia 200.57 11.21 598 149561 170311 110268829
Road traffic accident 198.71 11.21 446 149713 106952 110332188
Arthralgia 195.50 11.21 1761 148398 777871 109661269
Anaemia 186.47 11.21 284 149875 546802 109892338
Synovial cyst 185.71 11.21 141 150018 11289 110427851
Swollen joint count increased 183.10 11.21 372 149787 83289 110355851
Acute kidney injury 176.96 11.21 374 149785 635056 109804084
Death 173.18 11.21 438 149721 698431 109740709
Joint swelling 172.01 11.21 1109 149050 441736 109997404
Ankylosing spondylitis 168.69 11.21 152 150007 15460 110423680
Mobility decreased 157.90 11.21 690 149469 236732 110202408
Hypotension 153.73 11.21 299 149860 523550 109915590
Surgical failure 153.61 11.21 55 150104 879 110438261
Lupus vulgaris 153.43 11.21 209 149950 33674 110405466
X-ray abnormal 148.77 11.21 219 149940 37898 110401242
Joint range of motion decreased 146.42 11.21 430 149729 121402 110317738
Psoriasis 142.21 11.21 466 149693 139527 110299613
Drug hypersensitivity 141.55 11.21 1078 149081 453012 109986128
Bursitis 141.55 11.21 443 149716 129475 110309665
Rheumatoid factor positive 140.79 11.21 446 149713 131194 110307946
Musculoskeletal pain 139.76 11.21 555 149604 182468 110256672
Pancytopenia 139.38 11.21 55 150104 209558 110229582
Rheumatic fever 137.28 11.21 422 149737 122157 110316983
C-reactive protein 135.69 11.21 186 149973 30145 110408995
C-reactive protein abnormal 133.79 11.21 434 149725 129261 110309879
Discomfort 133.73 11.21 612 149547 214095 110225045
Blood cholesterol increased 129.74 11.21 546 149613 184239 110254901
Vital capacity decreased 129.46 11.21 61 150098 2012 110437128
Thrombocytopenia 125.75 11.21 174 149985 348711 110090429
Reversible airways obstruction 124.45 11.21 63 150096 2436 110436704
Osteoarthritis 123.10 11.21 533 149626 182090 110257050
Disease progression 121.65 11.21 92 150067 243942 110195198
Grip strength 121.09 11.21 100 150059 9041 110430099
Adjustment disorder with depressed mood 120.56 11.21 215 149944 43668 110395472
Knee arthroplasty 115.97 11.21 266 149893 64682 110374458
Tenosynovitis stenosans 115.87 11.21 68 150091 3535 110435605
Peripheral swelling 115.85 11.21 941 149218 403093 110036047
Porphyria acute 113.87 11.21 134 150025 18646 110420494
Liver disorder 110.71 11.21 434 149725 141809 110297331
Septic shock 110.34 11.21 38 150121 157490 110281650
Synovial fluid analysis 108.99 11.21 59 150100 2622 110436518
Cardiac failure 108.13 11.21 60 150099 187566 110251574
Sepsis 107.53 11.21 174 149985 327172 110111968
Myelosuppression 106.93 11.21 5 150154 94335 110344805
Malignant neoplasm progression 106.26 11.21 52 150107 174515 110264625
Contusion 104.08 11.21 606 149553 232755 110206385
Multiple organ dysfunction syndrome 103.86 11.21 38 150121 151672 110287468
Arthropathy 103.00 11.21 706 149453 286816 110152324
Drug interaction 101.54 11.21 344 149815 499839 109939301
Arthritis 100.86 11.21 473 149686 167113 110272027
Sinusitis 100.70 11.21 719 149440 295969 110143171
Hip arthroplasty 96.80 11.21 226 149933 55587 110383553
Hypoaesthesia 95.59 11.21 742 149417 313481 110125659
Lip dry 95.27 11.21 326 149833 99757 110339383
Spinal column injury 93.94 11.21 51 150108 2280 110436860
Sputum culture positive 93.55 11.21 61 150098 3828 110435312
Liver injury 93.06 11.21 428 149731 149985 110289155
Dry mouth 92.93 11.21 525 149634 199423 110239717
Duodenal ulcer perforation 90.94 11.21 479 149680 177221 110261919
Bronchitis chronic 89.34 11.21 65 150094 4875 110434265
Dislocation of vertebra 88.14 11.21 188 149971 43533 110395607
Grip strength decreased 87.87 11.21 274 149885 79900 110359240
Exostosis 87.38 11.21 193 149966 45763 110393377
Scleritis 86.15 11.21 66 150093 5354 110433786
Respiratory failure 85.22 11.21 100 150059 215232 110223908
Pain in extremity 85.00 11.21 1023 149136 486095 109953045
Sleep disorder due to general medical condition, insomnia type 84.37 11.21 325 149834 105318 110333822
Visual impairment 83.52 11.21 383 149776 134045 110305095
Asthma 83.43 11.21 604 149555 249687 110189453
Blister 83.00 11.21 561 149598 226815 110212325
Blood creatinine increased 82.44 11.21 76 150083 182813 110256327
Toxicity to various agents 82.32 11.21 354 149805 480201 109958939
Pleural effusion 82.32 11.21 72 150087 177637 110261503
Bronchial secretion retention 81.67 11.21 62 150097 4962 110434178
Foot deformity 81.56 11.21 194 149965 48286 110390854
Pain 78.54 11.21 1771 148388 953184 109485956
Night sweats 78.30 11.21 375 149784 133608 110305532
Drug abuse 76.16 11.21 77 150082 177334 110261806
Laryngitis 73.84 11.21 172 149987 42239 110396901
Neck surgery 73.52 11.21 42 150117 2075 110437065
Retinitis 73.40 11.21 146 150013 32181 110406959
Hyperkalaemia 73.21 11.21 47 150112 135749 110303391
Type 2 diabetes mellitus 73.08 11.21 451 149708 176781 110262359
Hepatic function abnormal 72.88 11.21 16 150143 89279 110349861
Blood folate decreased 72.29 11.21 43 150116 2292 110436848
Tenosynovitis 71.54 11.21 99 150060 16184 110422956
Prescribed overdose 71.21 11.21 271 149888 87310 110351830
Ear infection 71.16 11.21 217 149942 62515 110376625
Lung disorder 71.03 11.21 453 149706 179594 110259546
Gait disturbance 70.71 11.21 631 149528 277577 110161563
Injury 69.93 11.21 446 149713 176819 110262321
Platelet count decreased 69.71 11.21 129 150030 230314 110208826
Bone density decreased 69.68 11.21 97 150062 15945 110423195
Oedema 69.55 11.21 506 149653 209470 110229670
Swollen joint count 68.34 11.21 71 150088 8603 110430537
Walking aid user 67.78 11.21 122 150037 24953 110414187
Hyponatraemia 66.58 11.21 121 150038 217532 110221608
Muscle injury 66.25 11.21 371 149788 140436 110298704
Hand deformity 65.86 11.21 515 149644 217991 110221149
Rheumatoid lung 65.34 11.21 51 150108 4253 110434887
Crepitations 65.17 11.21 77 150082 10758 110428382
Memory impairment 64.88 11.21 474 149685 196470 110242670
Infection 64.15 11.21 763 149396 361437 110077703
Intestinal diaphragm disease 63.89 11.21 24 150135 442 110438698
Neutrophil count decreased 63.65 11.21 43 150116 120898 110318242
Pyrexia 63.56 11.21 849 149310 897416 109541724
Gait inability 63.28 11.21 358 149801 136018 110303122
Sleep disorder due to a general medical condition 62.64 11.21 184 149975 51928 110387212
Renal failure 62.38 11.21 134 150025 226440 110212700
Hypoxia 61.78 11.21 51 150108 129464 110309676
Anxiety 61.57 11.21 728 149431 344350 110094790
Helicobacter infection 61.21 11.21 440 149719 181437 110257703
Bone erosion 60.86 11.21 169 149990 46202 110392938
Folliculitis 60.77 11.21 413 149746 167240 110271900
Abdominal pain upper 59.88 11.21 731 149428 348380 110090760
Agranulocytosis 59.50 11.21 7 150152 61753 110377387
Lupus-like syndrome 58.90 11.21 154 150005 40638 110398502
Amnesia 58.69 11.21 291 149868 105117 110334023
Dry eye 58.68 11.21 188 149971 55605 110383535
Allergy to chemicals 58.44 11.21 43 150116 3282 110435858
Pregnancy 58.25 11.21 177 149982 50890 110388250
Cholestasis 58.14 11.21 9 150150 64509 110374631
Photophobia 58.04 11.21 116 150043 25655 110413485
Product dose omission issue 57.91 11.21 680 149479 321102 110118038
Wheezing 57.39 11.21 564 149595 254666 110184474
Drug tolerance decreased 57.33 11.21 120 150039 27420 110411720
Therapeutic product effect decreased 55.97 11.21 542 149617 243774 110195366
Pulmonary fibrosis 55.61 11.21 280 149879 101762 110337378
Synovitis 55.58 11.21 593 149566 273499 110165641
Aspartate aminotransferase increased 55.36 11.21 82 150077 159854 110279286
Wound infection 54.91 11.21 268 149891 96197 110342943
Antinuclear antibody positive 54.89 11.21 65 150094 9103 110430037
Breast cancer stage III 54.88 11.21 233 149926 78884 110360256
Syncope 54.74 11.21 121 150038 202415 110236725
Ascites 54.44 11.21 29 150130 92779 110346361
Rhabdomyolysis 54.29 11.21 50 150109 120351 110318789
Joint stiffness 53.78 11.21 207 149952 67036 110372104
Accident 53.32 11.21 70 150089 10882 110428258
Anti-cyclic citrullinated peptide antibody positive 53.23 11.21 426 149733 181558 110257582
Neck pain 53.08 11.21 317 149842 122813 110316327
Multiple allergies 53.04 11.21 74 150085 12189 110426951
Cytomegalovirus infection 52.87 11.21 6 150153 54438 110384702
Drug resistance 52.82 11.21 7 150152 56367 110382773
Seizure 52.80 11.21 141 150018 221044 110218096
Pulmonary toxicity 52.71 11.21 90 150069 17656 110421484
Peripheral venous disease 52.48 11.21 240 149919 83877 110355263
Live birth 52.42 11.21 210 149949 69274 110369866
Mucosal inflammation 52.19 11.21 33 150126 96108 110343032
Joint effusion 51.83 11.21 98 150061 20807 110418333
Delirium 51.57 11.21 337 149822 134688 110304452
Feeling jittery 50.95 11.21 80 150079 14642 110424498
Electrocardiogram QT prolonged 50.63 11.21 44 150115 108916 110330224
Upper-airway cough syndrome 50.54 11.21 83 150076 15774 110423366
Back pain 50.47 11.21 745 149414 370251 110068889
Cushingoid 49.65 11.21 70 150089 11642 110427498
International normalised ratio increased 49.61 11.21 28 150131 86744 110352396
Laboratory test abnormal 49.55 11.21 152 150007 43927 110395213
Alopecia 49.44 11.21 732 149427 364021 110075119
Ulcer haemorrhage 48.93 11.21 100 150059 22471 110416669
Hepatic cytolysis 48.89 11.21 8 150151 55045 110384095
Bradycardia 48.87 11.21 85 150074 155432 110283708
Haematuria 48.60 11.21 26 150133 82979 110356161
Pulmonary embolism 48.02 11.21 141 150018 214333 110224807
Cardiac failure congestive 47.93 11.21 82 150077 150918 110288222
Irritable bowel syndrome 47.26 11.21 383 149776 163832 110275308
Blood bilirubin increased 47.18 11.21 22 150137 75950 110363190
Muscular weakness 46.89 11.21 530 149629 247938 110191202
Alanine aminotransferase increased 46.29 11.21 114 150045 183659 110255481
Linear IgA disease 45.98 11.21 42 150117 4347 110434793
Dehydration 45.93 11.21 209 149950 279302 110159838
Tenderness 45.47 11.21 114 150045 29323 110409817
Respiratory distress 44.26 11.21 19 150140 68855 110370285
Sleep disorder 44.17 11.21 438 149721 198206 110240934
Eosinophilia 44.12 11.21 12 150147 57924 110381216
Pneumonia aspiration 43.93 11.21 28 150131 81205 110357935
Anti-cyclic citrullinated peptide antibody 43.93 11.21 89 150070 19875 110419265
Hypoglycaemia 43.72 11.21 56 150103 116048 110323092
Lipoma 43.70 11.21 39 150120 3916 110435224
Pneumonitis 43.32 11.21 25 150134 76506 110362634
Cytokine release syndrome 42.68 11.21 21 150138 70285 110368855
Hypokalaemia 42.27 11.21 118 150041 182330 110256810
Flank pain 41.57 11.21 95 150064 23035 110416105
Ill-defined disorder 41.50 11.21 359 149800 156494 110282646
Cerebrovascular accident 41.44 11.21 118 150041 181166 110257974
Listless 41.16 11.21 40 150119 4475 110434665
Abdominal discomfort 40.66 11.21 756 149403 393102 110046038
Treatment failure 40.59 11.21 564 149595 276670 110162470
Impaired work ability 40.48 11.21 102 150057 26317 110412823
Acute myeloid leukaemia 40.21 11.21 3 150156 38107 110401033
Muscle spasms 39.96 11.21 564 149595 277593 110161547
Clostridium difficile colitis 39.69 11.21 6 150153 43772 110395368
Impaired healing 39.58 11.21 425 149734 196292 110242848
Hepatocellular injury 39.49 11.21 10 150149 50632 110388508
Nasopharyngitis 39.34 11.21 753 149406 393608 110045532
Breast cancer stage II 39.17 11.21 103 150056 27272 110411868
Pruritus 38.80 11.21 1049 149110 580511 109858629
Hyperglycaemia 38.76 11.21 35 150124 85055 110354085
Maternal exposure timing unspecified 38.54 11.21 87 150072 20926 110418214
Epistaxis 38.51 11.21 74 150085 130298 110308842
Altered state of consciousness 38.48 11.21 15 150144 57611 110381529
Drug intolerance 38.46 11.21 770 149389 405742 110033398
Blood creatine phosphokinase increased 38.42 11.21 26 150133 73051 110366089
Pneumocystis jirovecii pneumonia 38.42 11.21 6 150153 42729 110396411
Respiratory disorder 38.28 11.21 195 149964 71187 110367953
Eye irritation 38.20 11.21 116 150043 33336 110405804
Rash pruritic 38.19 11.21 246 149913 97823 110341317
Acute hepatic failure 38.11 11.21 3 150156 36465 110402675
Ear pain 37.88 11.21 158 150001 53068 110386072
Pulmonary mass 37.69 11.21 124 150035 37177 110401963
Tachycardia 37.51 11.21 169 149990 226476 110212664
Overdose 37.12 11.21 177 149982 233617 110205523
Prescribed underdose 37.04 11.21 181 149978 64993 110374147
Depression 36.98 11.21 621 149538 316714 110122426
Leukopenia 36.92 11.21 93 150066 148698 110290442
Gastric haemorrhage 36.27 11.21 72 150087 15843 110423297
Viral upper respiratory tract infection 36.06 11.21 56 150103 10152 110428988
Myocardial infarction 35.66 11.21 137 150022 191946 110247194
Colitis 34.88 11.21 53 150106 102270 110336870
Posterior reversible encephalopathy syndrome 34.79 11.21 3 150156 33858 110405282
Gamma-glutamyltransferase increased 34.74 11.21 20 150139 61289 110377851
Renal impairment 34.60 11.21 135 150024 188310 110250830
Hepatitis 34.36 11.21 43 150116 90011 110349129
Hepatic failure 34.12 11.21 26 150133 68713 110370427
Bone marrow failure 34.04 11.21 18 150141 57830 110381310
Sedation 33.77 11.21 27 150132 69656 110369484
Obesity 33.49 11.21 266 149893 113085 110326055
Migraine 33.21 11.21 368 149791 171284 110267856
Aggression 32.58 11.21 20 150139 59190 110379950
Somatic delusion 32.51 11.21 17 150142 704 110438436
Prostatic pain 32.47 11.21 13 150146 286 110438854
Facet joint syndrome 32.41 11.21 234 149925 96594 110342546
Therapy non-responder 32.17 11.21 341 149818 156966 110282174
Musculoskeletal discomfort 32.09 11.21 87 150072 23451 110415689
Pleuritic pain 32.06 11.21 69 150090 16071 110423069
Ejection fraction decreased 32.02 11.21 8 150151 40872 110398268
Injection site pain 31.98 11.21 376 149783 177546 110261594
Anaphylactic shock 31.90 11.21 15 150144 51531 110387609
Xyphoid retraction 31.55 11.21 11 150148 162 110438978
Joint dislocation 31.33 11.21 110 150049 34080 110405060
Feeling abnormal 31.21 11.21 379 149780 180332 110258808
Constipation 31.06 11.21 323 149836 357463 110081677
Coronary artery disease 30.89 11.21 31 150128 71659 110367481
Corneal reflex decreased 30.67 11.21 15 150144 538 110438602
Lower respiratory tract infection 30.64 11.21 482 149677 242624 110196516
Ventricular fibrillation 30.63 11.21 9 150150 41304 110397836
Disseminated intravascular coagulation 30.60 11.21 9 150150 41277 110397863
Hypermobility syndrome 30.49 11.21 15 150144 545 110438595
Gastrointestinal disorder 30.23 11.21 479 149680 241473 110197667
Neuroleptic malignant syndrome 30.13 11.21 5 150154 34054 110405086
Synovial disorder 30.00 11.21 28 150131 2979 110436161
Intentional self-injury 29.95 11.21 7 150152 37422 110401718
Gastric ulcer 29.74 11.21 120 150039 39707 110399433
Metastases to liver 29.57 11.21 6 150153 35380 110403760
Conjunctivitis 29.50 11.21 107 150052 33685 110405455
Wound 29.24 11.21 464 149695 233973 110205167
Spinal operation 29.16 11.21 53 150106 10919 110428221
Nodule 29.06 11.21 104 150055 32527 110406613
Transaminases increased 28.96 11.21 26 150133 63364 110375776
Dysphagia 28.87 11.21 109 150050 153491 110285649
Haematochezia 28.82 11.21 72 150087 115452 110323688
Pulmonary hypertension 28.56 11.21 20 150139 55200 110383940
Sputum culture 28.48 11.21 12 150147 302 110438838
Tumour lysis syndrome 28.44 11.21 4 150155 30797 110408343
Neutropenic sepsis 28.37 11.21 4 150155 30742 110408398
Bacteraemia 28.36 11.21 11 150148 42379 110396761
Shock 28.26 11.21 19 150140 53569 110385571
Hypercalcaemia 28.22 11.21 14 150145 46643 110392497
Seronegative arthritis 28.11 11.21 58 150101 13119 110426021
Cerebral haemorrhage 28.09 11.21 28 150131 64940 110374200
Arthrofibrosis 27.80 11.21 9 150150 104 110439036
Atrial fibrillation 27.74 11.21 190 149969 229452 110209688
Hepatic encephalopathy 27.73 11.21 3 150156 28253 110410887
Weight fluctuation 27.39 11.21 79 150080 22066 110417074
Haemoptysis 27.30 11.21 34 150125 71320 110367820
Hypomagnesaemia 27.29 11.21 25 150134 60345 110378795
Bronchopulmonary aspergillosis 27.29 11.21 4 150155 29859 110409281
Cardiac arrest 27.27 11.21 156 150003 196597 110242543
Pancreatitis acute 27.20 11.21 25 150134 60249 110378891
Orthostatic hypotension 27.02 11.21 30 150129 66219 110372921
Blood pressure decreased 26.98 11.21 74 150085 115017 110324123
Eye injury 26.64 11.21 42 150117 7713 110431427
Deep vein thrombosis 26.46 11.21 99 150060 139788 110299352
Neoplasm malignant 26.23 11.21 110 150049 37033 110402107
Blood alkaline phosphatase increased 25.90 11.21 35 150124 70900 110368240
Loss of personal independence in daily activities 25.62 11.21 314 149845 149706 110289434
Carpal tunnel syndrome 25.44 11.21 78 150081 22532 110416608
Product use in unapproved indication 25.32 11.21 441 149718 446936 109992204
Mitral valve incompetence 25.20 11.21 7 150152 33322 110405818
Ventricular tachycardia 24.71 11.21 19 150140 49990 110389150
Head discomfort 24.69 11.21 69 150090 18931 110420209
Therapeutic response decreased 24.55 11.21 219 149940 96280 110342860
Abortion spontaneous 24.47 11.21 8 150151 34274 110404866
Aspergillus infection 24.43 11.21 3 150156 25613 110413527
Hepatic cirrhosis 24.13 11.21 166 149993 67460 110371680
Dermatitis atopic 24.12 11.21 83 150076 25458 110413682
Injection site bruising 24.05 11.21 135 150024 51128 110388012
Ischaemic stroke 24.04 11.21 13 150146 41250 110397890
Intervertebral disc degeneration 23.82 11.21 66 150093 18019 110421121
Rheumatoid nodule 23.76 11.21 71 150088 20225 110418915
White blood cell count increased 23.73 11.21 218 149941 96624 110342516
Surgery 23.71 11.21 115 150044 41168 110397972
Glossodynia 23.53 11.21 428 149731 221576 110217564
Appendicitis 23.43 11.21 5 150154 28459 110410681
Sacroiliitis 22.98 11.21 31 150128 4947 110434193
Lymphopenia 22.91 11.21 13 150146 40157 110398983
Anuria 22.86 11.21 3 150156 24338 110414802
Feeling hot 22.78 11.21 206 149953 90900 110348240
Proteinuria 22.75 11.21 13 150146 40005 110399135
Neoplasm progression 22.46 11.21 33 150126 64562 110374578
Palmar-plantar erythrodysaesthesia syndrome 22.38 11.21 14 150145 41011 110398129
Thrombotic microangiopathy 22.26 11.21 6 150153 29143 110409997
Somnolence 22.10 11.21 278 149881 297171 110141969
Fixed eruption 22.09 11.21 28 150131 4204 110434936
Reduced facial expression 22.05 11.21 26 150133 3625 110435515
Malaise 21.99 11.21 1119 149040 670700 109768440
Pulmonary oedema 21.93 11.21 67 150092 100592 110338548
Jaundice 21.86 11.21 29 150130 59207 110379933
Cerebral infarction 21.67 11.21 23 150136 51815 110387325
Duodenal ulcer 21.66 11.21 67 150092 19447 110419693
Status epilepticus 21.44 11.21 8 150151 31563 110407577
Swelling 21.35 11.21 626 149533 350415 110088725
Progressive multifocal leukoencephalopathy 21.34 11.21 4 150155 24952 110414188
Therapy partial responder 21.12 11.21 12 150147 37049 110402091
Injection site erythema 21.09 11.21 208 149951 93968 110345172
Abdominal distension 21.08 11.21 145 150014 174958 110264182
Injection site swelling 21.07 11.21 150 150009 61640 110377500
Therapy cessation 20.96 11.21 118 150041 44739 110394401
Poisoning deliberate 20.92 11.21 5 150154 26326 110412814
Injection site vesicles 20.88 11.21 28 150131 4443 110434697
Splenomegaly 20.79 11.21 4 150155 24494 110414646
Red blood cell sedimentation rate decreased 20.67 11.21 16 150143 1318 110437822
Accidental overdose 20.57 11.21 24 150135 51810 110387330
Suicide attempt 20.33 11.21 72 150087 103322 110335818
Systemic lupus erythematosus 20.25 11.21 470 149689 253868 110185272
Drug eruption 20.08 11.21 26 150133 53633 110385507
Red blood cell sedimentation rate increased 20.07 11.21 178 149981 78124 110361016
Limb asymmetry 20.07 11.21 12 150147 646 110438494
Paraesthesia 19.90 11.21 504 149655 276017 110163123
Dysarthria 19.78 11.21 54 150105 84067 110355073
Creatinine renal clearance decreased 19.75 11.21 3 150156 21812 110417328
Poliomyelitis 19.68 11.21 6 150153 56 110439084
Hallucination, visual 19.63 11.21 15 150144 39590 110399550
Device related infection 19.55 11.21 15 150144 39504 110399636
Eosinophil count increased 19.51 11.21 68 150091 20990 110418150
Chest discomfort 19.46 11.21 147 150012 173701 110265439
Dyspnoea exertional 19.45 11.21 74 150085 103986 110335154
Pulmonary arterial hypertension 19.36 11.21 10 150149 32558 110406582
Product dose omission in error 19.31 11.21 73 150086 23439 110415701
Ankle fracture 19.24 11.21 65 150094 19754 110419386
Sinus bradycardia 19.15 11.21 8 150151 29475 110409665
Abnormal behaviour 19.08 11.21 15 150144 39024 110400116
Neuropathy peripheral 18.94 11.21 154 150005 179123 110260017
Chest pain 18.92 11.21 656 149503 375719 110063421
Epilepsy 18.90 11.21 71 150088 100138 110339002
Agitation 18.88 11.21 84 150075 112967 110326173
Myelodysplastic syndrome 18.83 11.21 14 150145 37470 110401670
Ocular hyperaemia 18.79 11.21 104 150055 39182 110399958
Knee operation 18.77 11.21 34 150125 6988 110432152
Iritis 18.54 11.21 27 150132 4625 110434515
Hypocalcaemia 18.53 11.21 38 150121 65328 110373812
Fall 18.27 11.21 653 149506 602829 109836311
Muscle rigidity 18.25 11.21 5 150154 24026 110415114
Tachypnoea 18.19 11.21 16 150143 39379 110399761
Circulatory collapse 18.05 11.21 19 150140 42974 110396166
Parkinsonism 18.05 11.21 4 150155 22183 110416957
Manipulation 17.89 11.21 6 150153 78 110439062
Pseudoporphyria 17.87 11.21 12 150147 791 110438349
Hypersensitivity 17.85 11.21 694 149465 403304 110035836
Subdural haematoma 17.82 11.21 14 150145 36440 110402700
Coordination abnormal 17.81 11.21 6 150153 25222 110413918
Angioedema 17.80 11.21 71 150088 98429 110340711
Eyelid retraction 17.69 11.21 6 150153 81 110439059
Schizophrenia 17.63 11.21 4 150155 21822 110417318
Drug reaction with eosinophilia and systemic symptoms 17.63 11.21 55 150104 82040 110357100
Klebsiella infection 17.56 11.21 3 150156 20006 110419134
Ischaemic gastritis 17.55 11.21 5 150154 36 110439104
Face oedema 17.47 11.21 12 150147 33457 110405683
Cardiogenic shock 17.41 11.21 32 150127 57306 110381834
Hyperbilirubinaemia 17.38 11.21 10 150149 30661 110408479
Intentional overdose 17.33 11.21 107 150052 132394 110306746
Eye pain 17.30 11.21 122 150037 49977 110389163
Headache 17.06 11.21 1405 148754 880972 109558168
Hepatotoxicity 17.02 11.21 38 150121 63362 110375778
Hyperthermia 16.98 11.21 4 150155 21268 110417872
Osteoporosis 16.92 11.21 187 149972 86965 110352175
Pemphigus 16.92 11.21 396 149763 214174 110224966
Purpura 16.87 11.21 6 150153 24382 110414758
Pericarditis 16.85 11.21 403 149756 218711 110220429
Hemiplegia 16.82 11.21 5 150154 22777 110416363
Aplastic anaemia 16.78 11.21 6 150153 24302 110414838
Trigger finger 16.70 11.21 27 150132 5065 110434075
Small intestinal stenosis 16.64 11.21 14 150145 1299 110437841
Deformity 16.38 11.21 40 150119 10120 110429020
Hypercholesterolaemia 16.33 11.21 192 149967 90645 110348495
Hypophagia 16.31 11.21 29 150130 52597 110386543
Oesophageal mucosal tear 16.20 11.21 4 150155 15 110439125
Toxic epidermal necrolysis 16.06 11.21 33 150126 56694 110382446
Generalised oedema 16.04 11.21 11 150148 30693 110408447
Blood calcium decreased 16.02 11.21 15 150144 35830 110403310
Chronic sinusitis 15.99 11.21 7 150152 25077 110414063
Hypophosphataemia 15.90 11.21 13 150146 33169 110405971
Left ventricular dysfunction 15.88 11.21 6 150153 23487 110415653
Tender joint count 15.80 11.21 14 150145 1393 110437747
Cartilage injury 15.73 11.21 15 150144 1639 110437501
Salpingo-oophorectomy bilateral 15.72 11.21 8 150151 313 110438827
Lymphocyte count decreased 15.62 11.21 34 150125 57209 110381931
Oxygen saturation decreased 15.61 11.21 137 150022 156845 110282295
Pneumothorax 15.50 11.21 15 150144 35270 110403870
Hepatic enzyme decreased 15.49 11.21 12 150147 990 110438150
Food allergy 15.44 11.21 4 150155 19944 110419196
Metastases to bone 15.40 11.21 12 150147 31360 110407780
Angina pectoris 15.40 11.21 39 150120 62256 110376884
Bezoar 15.39 11.21 23 150136 4031 110435109
Skin necrosis 15.39 11.21 5 150154 21507 110417633
Arrhythmia 15.37 11.21 46 150113 69529 110369611
Nodular rash 15.37 11.21 8 150151 328 110438812
Diabetes mellitus inadequate control 15.11 11.21 11 150148 29764 110409376
Diabetic ketoacidosis 15.10 11.21 21 150138 42037 110397103
Coeliac disease 15.08 11.21 22 150137 43165 110395975
Urine odour abnormal 15.07 11.21 32 150127 7383 110431757
Haematoma 14.93 11.21 36 150123 58440 110380700
Hyperlipidaemia 14.88 11.21 16 150143 35832 110403308
Electrolyte imbalance 14.85 11.21 17 150142 37011 110402129
Blood glucose increased 14.84 11.21 112 150047 132384 110306756
Vulvovaginal adhesion 14.73 11.21 3 150156 3 110439137
Disorientation 14.72 11.21 48 150111 70623 110368517
Tendon disorder 14.71 11.21 34 150125 8303 110430837
Hemiparesis 14.71 11.21 23 150136 43880 110395260
Spinal fusion surgery 14.71 11.21 36 150123 9120 110430020
Frequent bowel movements 14.70 11.21 155 150004 71235 110367905
Myocardial ischaemia 14.70 11.21 9 150150 26675 110412465
Leukocytosis 14.66 11.21 32 150127 53796 110385344
Escherichia infection 14.63 11.21 7 150152 23809 110415331
Aspiration 14.58 11.21 12 150147 30521 110408619
Dysphoria 14.55 11.21 29 150130 6399 110432741
Enteritis 14.52 11.21 4 150155 19152 110419988
Insomnia 14.44 11.21 613 149546 359977 110079163
Inflammation 14.43 11.21 354 149805 192884 110246256
Candida infection 14.39 11.21 27 150132 47982 110391158
Foreign body 14.36 11.21 19 150140 2976 110436164
Haemophagocytic lymphohistiocytosis 14.35 11.21 13 150146 31546 110407594
Haemorrhage intracranial 14.32 11.21 11 150148 28958 110410182
Nasal mucosal discolouration 14.19 11.21 5 150154 76 110439064
Blood lactate dehydrogenase increased 14.13 11.21 24 150135 44310 110394830
Completed suicide 14.12 11.21 430 149729 241951 110197189
Epstein-Barr virus infection 14.04 11.21 4 150155 18734 110420406
Psychomotor hyperactivity 14.00 11.21 5 150154 20272 110418868
Coma 13.99 11.21 98 150061 117771 110321369
Malnutrition 13.95 11.21 10 150149 27269 110411871
Shock haemorrhagic 13.92 11.21 10 150149 27237 110411903
Cardiomyopathy 13.87 11.21 15 150144 33510 110405630
Metabolic acidosis 13.86 11.21 79 150080 99665 110339475
Haematemesis 13.85 11.21 38 150121 59070 110380070
Cyanosis 13.82 11.21 12 150147 29729 110409411
Hypervolaemia 13.81 11.21 29 150130 49431 110389709
Lymphomatoid papulosis 13.79 11.21 8 150151 407 110438733
Disability 13.79 11.21 79 150080 30144 110408996
Thalassaemia minor 13.67 11.21 4 150155 32 110439108
Atelectasis 13.63 11.21 91 150068 36621 110402519
Product prescribing error 13.59 11.21 31 150128 51300 110387840
Pancreatitis 13.55 11.21 190 149969 93343 110345797
Oesophageal infection 13.53 11.21 10 150149 768 110438372
Adverse event 13.42 11.21 215 149944 108594 110330546
Pelvic adhesions 13.40 11.21 7 150152 289 110438851
Breath sounds abnormal 13.40 11.21 9 150150 25395 110413745
Drug use disorder 13.29 11.21 4 150155 18070 110421070
Sleep disorder due to general medical condition, hypersomnia type 13.24 11.21 15 150144 2004 110437136
Cholangitis 13.18 11.21 3 150156 16332 110422808
Dyspepsia 13.13 11.21 346 149813 190619 110248521
Activated partial thromboplastin time prolonged 13.10 11.21 7 150152 22361 110416779
Hypoalbuminaemia 13.10 11.21 12 150147 28962 110410178
Onychomycosis 13.09 11.21 20 150139 38511 110400629
Platelet count increased 13.02 11.21 10 150149 26324 110412816
Myocarditis 12.94 11.21 13 150146 30042 110409098
Pathogen resistance 12.83 11.21 4 150155 17668 110421472
Spinal disorder 12.77 11.21 40 150119 11688 110427452
Product administration interrupted 12.74 11.21 39 150120 11253 110427887
Pallor 12.72 11.21 37 150122 56430 110382710
Respiratory tract infection 12.70 11.21 151 150008 71466 110367674
Blood test abnormal 12.70 11.21 12 150147 28542 110410598
Ligament rupture 12.70 11.21 21 150138 4014 110435126
Lung infiltration 12.63 11.21 9 150150 24619 110414521
Cardiac murmur 12.63 11.21 9 150150 24619 110414521
Vomiting 12.59 11.21 1065 149094 909610 109529530
Stress cardiomyopathy 12.56 11.21 3 150156 15803 110423337
Encephalopathy 12.49 11.21 62 150097 80993 110358147
Quality of life decreased 12.48 11.21 45 150114 14124 110425016
Foot fracture 12.47 11.21 68 150091 25478 110413662
Acute coronary syndrome 12.45 11.21 8 150151 23104 110416036
Adverse drug reaction 12.43 11.21 207 149952 105352 110333788
Sudden death 12.40 11.21 9 150150 24386 110414754
Urosepsis 12.39 11.21 14 150145 30661 110408479
Blood urea increased 12.39 11.21 36 150123 54921 110384219
Myasthenia gravis 12.21 11.21 7 150152 21504 110417636
Drug level decreased 12.10 11.21 5 150154 18543 110420597
Cardiovascular disorder 12.09 11.21 8 150151 22752 110416388
Inappropriate antidiuretic hormone secretion 12.06 11.21 17 150142 33834 110405306
Bacterial infection 12.03 11.21 28 150131 46008 110393132
Proctitis 11.99 11.21 4 150155 16923 110422217
Colitis ulcerative 11.96 11.21 159 150000 77204 110361936
COVID-19 pneumonia 11.94 11.21 20 150139 37123 110402017
Myofascial pain syndrome 11.84 11.21 16 150143 2557 110436583
Drug dependence 11.84 11.21 32 150127 49988 110389152
Pericardial effusion 11.82 11.21 39 150120 57178 110381962
Back disorder 11.81 11.21 58 150101 20864 110418276
Hypothermia 11.76 11.21 11 150148 26291 110412849
Tarsal tunnel syndrome 11.73 11.21 8 150151 541 110438599
Peripheral sensory neuropathy 11.71 11.21 4 150155 16676 110422464
Brain oedema 11.70 11.21 15 150144 31083 110408057
Drug level increased 11.70 11.21 30 150129 47689 110391451
Haemoglobin decreased 11.67 11.21 253 149906 248474 110190666
Hypothyroidism 11.67 11.21 55 150104 72844 110366296
Pelvic fracture 11.67 11.21 44 150115 14110 110425030
Visual acuity reduced 11.62 11.21 16 150143 32157 110406983
Depressed level of consciousness 11.61 11.21 97 150062 112181 110326959
Troponin increased 11.58 11.21 14 150145 29752 110409388
Small intestinal ulcer haemorrhage 11.57 11.21 5 150154 134 110439006
Haemorrhagic diathesis 11.51 11.21 29 150130 7479 110431661
Gastroenteritis 11.48 11.21 22 150137 38778 110400362
Pupillary reflex impaired 11.45 11.21 20 150139 3995 110435145
Pneumonia 11.42 11.21 1030 149129 875684 109563456
Reflux gastritis 11.35 11.21 12 150147 1484 110437656
Blood phosphorus increased 11.34 11.21 4 150155 16336 110422804
Vaginal neoplasm 11.28 11.21 4 150155 62 110439078
Red blood cell sedimentation rate abnormal 11.26 11.21 10 150149 24499 110414641
Prostatic specific antigen increased 11.25 11.21 40 150119 12471 110426669

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 D000893 Anti-Inflammatory Agents
MeSH PA D000894 Anti-Inflammatory Agents, Non-Steroidal
MeSH PA D004791 Enzyme Inhibitors
MeSH PA D016861 Cyclooxygenase Inhibitors
MeSH PA D018501 Antirheumatic Agents
MeSH PA D018689 Sensory System Agents
MeSH PA D018712 Analgesics, Non-Narcotic
MeSH PA D052246 Cyclooxygenase 2 Inhibitors
CHEBI has role CHEBI:33231 antitubercular agent
CHEBI has role CHEBI:35475 non-steroidal anti-inflammatory drug
CHEBI has role CHEBI:35480 analgesic
CHEBI has role CHEBI:35610 antineoplastic agent
CHEBI has role CHEBI:35842 antirheumatic drug
CHEBI has role CHEBI:50629 cyclooxygenase 2 inhibitor
CHEBI has role CHEBI:67079 anti-inflammatory agent
FDA EPC N0000175722 Nonsteroidal Anti-inflammatory Drug

Related Drugs by ATC class:

M01AC Oxicams 4 drugs
droxicamlornoxicampiroxicamtenoxicam
N01BB Amides 10 drugs
articainebupivacainebutanilicainecinchocaineetidocainelevobupivacainelidocainemepivacaineprilocaineropivacaine

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) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** ANJESO BAUDAX N210583 Feb. 20, 2020 DISCN SOLUTION INTRAVENOUS 10709713 May 26, 2030 MANAGEMENT OF MODERATE-TO-SEVERE PAIN BY INTRAVENOUS INJECTION
30MG/ML (30MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** ANJESO BAUDAX N210583 Feb. 20, 2020 DISCN 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 11413350 April 20, 2035 TREATMENT OF POSTSURGICAL PAIN PROVIDING ANALGESIA TO A PATIENT FOR UP TO 72 HOURS, FOR EXAMPLE, AFTER FOOT AND ANKLE, SMALL-TO-MEDIUM OPEN ABDOMINAL, AND LOWER EXTREMITY TOTAL JOINT ARTHROPLASTY SURGICAL PROCEDURES VIA 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 11413350 April 20, 2035 TREATMENT OF POSTSURGICAL PAIN PROVIDING ANALGESIA TO A PATIENT FOR UP TO 72 HOURS, FOR EXAMPLE, AFTER FOOT AND ANKLE, SMALL-TO-MEDIUM OPEN ABDOMINAL, AND LOWER EXTREMITY TOTAL JOINT ARTHROPLASTY SURGICAL PROCEDURES VIA 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 11413350 April 20, 2035 TREATMENT OF POSTSURGICAL PAIN PROVIDING ANALGESIA TO A PATIENT FOR UP TO 72 HOURS, FOR EXAMPLE, AFTER FOOT AND ANKLE, SMALL-TO-MEDIUM OPEN ABDOMINAL, AND LOWER EXTREMITY TOTAL JOINT ARTHROPLASTY SURGICAL PROCEDURES VIA 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 11413350 April 20, 2035 TREATMENT OF POSTSURGICAL PAIN PROVIDING ANALGESIA TO A PATIENT FOR UP TO 72 HOURS, FOR EXAMPLE, AFTER FOOT AND ANKLE, SMALL-TO-MEDIUM OPEN ABDOMINAL, AND LOWER EXTREMITY TOTAL JOINT ARTHROPLASTY SURGICAL PROCEDURES VIA 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
20MG;EQ 10MG BASE SYMBRAVO AXSOME N215431 Jan. 30, 2025 RX TABLET ORAL 10029010 April 11, 2036 REDUCING TMAX OF ORALLY ADMINISTERED MELOXICAM
20MG;EQ 10MG BASE SYMBRAVO AXSOME N215431 Jan. 30, 2025 RX TABLET ORAL 10137131 April 11, 2036 ACUTE TREATMENT OF MIGRAINE
20MG;EQ 10MG BASE SYMBRAVO AXSOME N215431 Jan. 30, 2025 RX TABLET ORAL 10195278 April 11, 2036 ACUTE TREATMENT OF MIGRAINE
20MG;EQ 10MG BASE SYMBRAVO AXSOME N215431 Jan. 30, 2025 RX TABLET ORAL 10265324 April 11, 2036 ACUTE TREATMENT OF MIGRAINE
20MG;EQ 10MG BASE SYMBRAVO AXSOME N215431 Jan. 30, 2025 RX TABLET ORAL 10265399 April 11, 2036 IMPROVING ORAL BIOAVAILABILITY OF MELOXICAM FOR THE ACUTE TREATMENT OF MIGRAINE
20MG;EQ 10MG BASE SYMBRAVO AXSOME N215431 Jan. 30, 2025 RX TABLET ORAL 10265400 April 11, 2036 IMPROVING ORAL BIOAVAILABILITY OF MELOXICAM FOR THE ACUTE TREATMENT OF MIGRAINE
20MG;EQ 10MG BASE SYMBRAVO AXSOME N215431 Jan. 30, 2025 RX TABLET ORAL 10307484 April 11, 2036 IMPROVING ORAL BIOAVAILABILITY OF MELOXICAM FOR THE ACUTE TREATMENT OF MIGRAINE
20MG;EQ 10MG BASE SYMBRAVO AXSOME N215431 Jan. 30, 2025 RX TABLET ORAL 10363312 April 11, 2036 ACUTE TREATMENT OF MIGRAINE
20MG;EQ 10MG BASE SYMBRAVO AXSOME N215431 Jan. 30, 2025 RX TABLET ORAL 10369224 April 11, 2036 RAPID DELIVERY OF MELOXICAM TO THE BLOOD OF A HUMAN BEING
20MG;EQ 10MG BASE SYMBRAVO AXSOME N215431 Jan. 30, 2025 RX TABLET ORAL 10369225 April 11, 2036 IMPROVING THE PHARMACOKINETICS OF MELOXICAM IN A HUMAN BEING SUFFERING FROM MIGRAINE
20MG;EQ 10MG BASE SYMBRAVO AXSOME N215431 Jan. 30, 2025 RX TABLET ORAL 10426839 April 11, 2036 IMPROVING ORAL BIOAVAILABILITY OF MELOXICAM
20MG;EQ 10MG BASE SYMBRAVO AXSOME N215431 Jan. 30, 2025 RX TABLET ORAL 10456471 April 11, 2036 IMPROVING ORAL BIOAVAILABILITY OF MELOXICAM FOR THE ACUTE TREATMENT OF MIGRAINE
20MG;EQ 10MG BASE SYMBRAVO AXSOME N215431 Jan. 30, 2025 RX TABLET ORAL 10471014 April 11, 2036 ACUTE TREATMENT OF MIGRAINE
20MG;EQ 10MG BASE SYMBRAVO AXSOME N215431 Jan. 30, 2025 RX TABLET ORAL 10471069 April 11, 2036 ACUTE TREATMENT OF MIGRAINE
20MG;EQ 10MG BASE SYMBRAVO AXSOME N215431 Jan. 30, 2025 RX TABLET ORAL 10512692 April 11, 2036 ACUTE TREATMENT OF MIGRAINE
20MG;EQ 10MG BASE SYMBRAVO AXSOME N215431 Jan. 30, 2025 RX TABLET ORAL 10512693 April 11, 2036 ACUTE TREATMENT OF MIGRAINE
20MG;EQ 10MG BASE SYMBRAVO AXSOME N215431 Jan. 30, 2025 RX TABLET ORAL 10517950 April 11, 2036 ACUTE TREATMENT OF MIGRAINE
20MG;EQ 10MG BASE SYMBRAVO AXSOME N215431 Jan. 30, 2025 RX TABLET ORAL 10532101 April 11, 2036 ACUTE TREATMENT OF MIGRAINE
20MG;EQ 10MG BASE SYMBRAVO AXSOME N215431 Jan. 30, 2025 RX TABLET ORAL 10537642 April 11, 2036 ACUTE TREATMENT OF MIGRAINE
20MG;EQ 10MG BASE SYMBRAVO AXSOME N215431 Jan. 30, 2025 RX TABLET ORAL 10561664 April 11, 2036 ACUTE TREATMENT OF MIGRAINE
20MG;EQ 10MG BASE SYMBRAVO AXSOME N215431 Jan. 30, 2025 RX TABLET ORAL 10583144 April 11, 2036 ACUTE TREATMENT OF MIGRAINE
20MG;EQ 10MG BASE SYMBRAVO AXSOME N215431 Jan. 30, 2025 RX TABLET ORAL 10653777 April 11, 2036 ACUTE TREATMENT OF MIGRAINE
20MG;EQ 10MG BASE SYMBRAVO AXSOME N215431 Jan. 30, 2025 RX TABLET ORAL 10688102 April 11, 2036 ACUTE TREATMENT OF MIGRAINE
20MG;EQ 10MG BASE SYMBRAVO AXSOME N215431 Jan. 30, 2025 RX TABLET ORAL 10688185 April 11, 2036 ACUTE TREATMENT OF MIGRAINE
20MG;EQ 10MG BASE SYMBRAVO AXSOME N215431 Jan. 30, 2025 RX TABLET ORAL 10695429 April 11, 2036 ACUTE TREATMENT OF MIGRAINE
20MG;EQ 10MG BASE SYMBRAVO AXSOME N215431 Jan. 30, 2025 RX TABLET ORAL 10695430 April 11, 2036 ACUTE TREATMENT OF MIGRAINE
20MG;EQ 10MG BASE SYMBRAVO AXSOME N215431 Jan. 30, 2025 RX TABLET ORAL 10702535 April 11, 2036 ACUTE TREATMENT OF MIGRAINE ASSOCIATED WITH ALLODYNIA
20MG;EQ 10MG BASE SYMBRAVO AXSOME N215431 Jan. 30, 2025 RX TABLET ORAL 10702602 April 11, 2036 ACUTE TREATMENT OF MIGRAINE
20MG;EQ 10MG BASE SYMBRAVO AXSOME N215431 Jan. 30, 2025 RX TABLET ORAL 10722583 April 11, 2036 ACUTE TREATMENT OF MIGRAINE
20MG;EQ 10MG BASE SYMBRAVO AXSOME N215431 Jan. 30, 2025 RX TABLET ORAL 10729696 April 11, 2036 ACUTE TREATMENT OF MIGRAINE
20MG;EQ 10MG BASE SYMBRAVO AXSOME N215431 Jan. 30, 2025 RX TABLET ORAL 10729697 April 11, 2036 ACUTE TREATMENT OF MIGRAINE
20MG;EQ 10MG BASE SYMBRAVO AXSOME N215431 Jan. 30, 2025 RX TABLET ORAL 10729773 April 11, 2036 ACUTE TREATMENT OF MIGRAINE
20MG;EQ 10MG BASE SYMBRAVO AXSOME N215431 Jan. 30, 2025 RX TABLET ORAL 10758617 April 11, 2036 ACUTE TREATMENT OF MIGRAINE
20MG;EQ 10MG BASE SYMBRAVO AXSOME N215431 Jan. 30, 2025 RX TABLET ORAL 10758618 April 11, 2036 ACUTE TREATMENT OF MIGRAINE
20MG;EQ 10MG BASE SYMBRAVO AXSOME N215431 Jan. 30, 2025 RX TABLET ORAL 10780165 April 11, 2036 ACUTE TREATMENT OF MIGRAINE
20MG;EQ 10MG BASE SYMBRAVO AXSOME N215431 Jan. 30, 2025 RX TABLET ORAL 10780166 April 11, 2036 ACUTE TREATMENT OF MIGRAINE
20MG;EQ 10MG BASE SYMBRAVO AXSOME N215431 Jan. 30, 2025 RX TABLET ORAL 10799588 April 11, 2036 ACUTE TREATMENT OF MIGRAINE
20MG;EQ 10MG BASE SYMBRAVO AXSOME N215431 Jan. 30, 2025 RX TABLET ORAL 10821181 April 11, 2036 ACUTE TREATMENT OF MIGRAINE
20MG;EQ 10MG BASE SYMBRAVO AXSOME N215431 Jan. 30, 2025 RX TABLET ORAL 10821182 April 11, 2036 ACUTE TREATMENT OF MIGRAINE
20MG;EQ 10MG BASE SYMBRAVO AXSOME N215431 Jan. 30, 2025 RX TABLET ORAL 10894053 April 11, 2036 ACUTE TREATMENT OF MIGRAINE
20MG;EQ 10MG BASE SYMBRAVO AXSOME N215431 Jan. 30, 2025 RX TABLET ORAL 10905693 April 11, 2036 ACUTE TREATMENT OF MIGRAINE
20MG;EQ 10MG BASE SYMBRAVO AXSOME N215431 Jan. 30, 2025 RX TABLET ORAL 10918722 April 11, 2036 ACUTE TREATMENT OF MIGRAINE
20MG;EQ 10MG BASE SYMBRAVO AXSOME N215431 Jan. 30, 2025 RX TABLET ORAL 10933136 April 11, 2036 ACUTE TREATMENT OF MIGRAINE
20MG;EQ 10MG BASE SYMBRAVO AXSOME N215431 Jan. 30, 2025 RX TABLET ORAL 10933137 April 11, 2036 ACUTE TREATMENT OF MIGRAINE
20MG;EQ 10MG BASE SYMBRAVO AXSOME N215431 Jan. 30, 2025 RX TABLET ORAL 10940153 April 11, 2036 ACUTE TREATMENT OF MIGRAINE
20MG;EQ 10MG BASE SYMBRAVO AXSOME N215431 Jan. 30, 2025 RX TABLET ORAL 10987358 April 11, 2036 ACUTE TREATMENT OF MIGRAINE
20MG;EQ 10MG BASE SYMBRAVO AXSOME N215431 Jan. 30, 2025 RX TABLET ORAL 11013805 April 11, 2036 ACUTE TREATMENT OF MIGRAINE
20MG;EQ 10MG BASE SYMBRAVO AXSOME N215431 Jan. 30, 2025 RX TABLET ORAL 11013806 April 11, 2036 ACUTE TREATMENT OF MIGRAINE
20MG;EQ 10MG BASE SYMBRAVO AXSOME N215431 Jan. 30, 2025 RX TABLET ORAL 11020483 April 11, 2036 ACUTE TREATMENT OF MIGRAINE
20MG;EQ 10MG BASE SYMBRAVO AXSOME N215431 Jan. 30, 2025 RX TABLET ORAL 11045549 April 11, 2036 ACUTE TREATMENT OF MIGRAINE
20MG;EQ 10MG BASE SYMBRAVO AXSOME N215431 Jan. 30, 2025 RX TABLET ORAL 11135295 April 11, 2036 ACUTE TREATMENT OF MIGRAINE
20MG;EQ 10MG BASE SYMBRAVO AXSOME N215431 Jan. 30, 2025 RX TABLET ORAL 11207328 April 11, 2036 ACUTE TREATMENT OF MIGRAINE
20MG;EQ 10MG BASE SYMBRAVO AXSOME N215431 Jan. 30, 2025 RX TABLET ORAL 11219626 April 11, 2036 ACUTE TREATMENT OF MIGRAINE
20MG;EQ 10MG BASE SYMBRAVO AXSOME N215431 Jan. 30, 2025 RX TABLET ORAL 11266657 April 11, 2036 ACUTE TREATMENT OF MIGRAINE
20MG;EQ 10MG BASE SYMBRAVO AXSOME N215431 Jan. 30, 2025 RX TABLET ORAL 11285213 April 11, 2036 ACUTE TREATMENT OF MIGRAINE
20MG;EQ 10MG BASE SYMBRAVO AXSOME N215431 Jan. 30, 2025 RX TABLET ORAL 11331323 April 11, 2036 ACUTE TREATMENT OF MIGRAINE
20MG;EQ 10MG BASE SYMBRAVO AXSOME N215431 Jan. 30, 2025 RX TABLET ORAL 11369684 April 11, 2036 ACUTE TREATMENT OF MIGRAINE
20MG;EQ 10MG BASE SYMBRAVO AXSOME N215431 Jan. 30, 2025 RX TABLET ORAL 11426414 April 11, 2036 ACUTE TREATMENT OF MIGRAINE
20MG;EQ 10MG BASE SYMBRAVO AXSOME N215431 Jan. 30, 2025 RX TABLET ORAL 11433078 April 11, 2036 ACUTE TREATMENT OF MIGRAINE
20MG;EQ 10MG BASE SYMBRAVO AXSOME N215431 Jan. 30, 2025 RX TABLET ORAL 11433079 April 11, 2036 ACUTE TREATMENT OF MIGRAINE
20MG;EQ 10MG BASE SYMBRAVO AXSOME N215431 Jan. 30, 2025 RX TABLET ORAL 11471464 April 11, 2036 ACUTE TREATMENT OF MIGRAINE
20MG;EQ 10MG BASE SYMBRAVO AXSOME N215431 Jan. 30, 2025 RX TABLET ORAL 11471465 April 11, 2036 ACUTE TREATMENT OF MIGRAINE
20MG;EQ 10MG BASE SYMBRAVO AXSOME N215431 Jan. 30, 2025 RX TABLET ORAL 11504429 April 11, 2036 ACUTE TREATMENT OF MIGRAINE
20MG;EQ 10MG BASE SYMBRAVO AXSOME N215431 Jan. 30, 2025 RX TABLET ORAL 11510927 April 11, 2036 ACUTE TREATMENT OF MIGRAINE
20MG;EQ 10MG BASE SYMBRAVO AXSOME N215431 Jan. 30, 2025 RX TABLET ORAL 11571428 April 11, 2036 ACUTE TREATMENT OF MIGRAINE
20MG;EQ 10MG BASE SYMBRAVO AXSOME N215431 Jan. 30, 2025 RX TABLET ORAL 11602563 April 11, 2036 ACUTE TREATMENT OF MIGRAINE
20MG;EQ 10MG BASE SYMBRAVO AXSOME N215431 Jan. 30, 2025 RX TABLET ORAL 11607456 April 11, 2036 ACUTE TREATMENT OF MIGRAINE
20MG;EQ 10MG BASE SYMBRAVO AXSOME N215431 Jan. 30, 2025 RX TABLET ORAL 11617755 April 11, 2036 ACUTE TREATMENT OF MIGRAINE
20MG;EQ 10MG BASE SYMBRAVO AXSOME N215431 Jan. 30, 2025 RX TABLET ORAL 11617756 April 11, 2036 ACUTE TREATMENT OF MIGRAINE
20MG;EQ 10MG BASE SYMBRAVO AXSOME N215431 Jan. 30, 2025 RX TABLET ORAL 11617791 April 11, 2036 ACUTE TREATMENT OF MIGRAINE
20MG;EQ 10MG BASE SYMBRAVO AXSOME N215431 Jan. 30, 2025 RX TABLET ORAL 11628173 April 11, 2036 ACUTE TREATMENT OF MIGRAINE
20MG;EQ 10MG BASE SYMBRAVO AXSOME N215431 Jan. 30, 2025 RX TABLET ORAL 11712441 April 11, 2036 ACUTE TREATMENT OF MIGRAINE
20MG;EQ 10MG BASE SYMBRAVO AXSOME N215431 Jan. 30, 2025 RX TABLET ORAL 11738085 April 11, 2036 ACUTE TREATMENT OF MIGRAINE
20MG;EQ 10MG BASE SYMBRAVO AXSOME N215431 Jan. 30, 2025 RX TABLET ORAL 11759522 April 11, 2036 ACUTE TREATMENT OF MIGRAINE
20MG;EQ 10MG BASE SYMBRAVO AXSOME N215431 Jan. 30, 2025 RX TABLET ORAL 11801250 April 11, 2036 ACUTE TREATMENT OF MIGRAINE
20MG;EQ 10MG BASE SYMBRAVO AXSOME N215431 Jan. 30, 2025 RX TABLET ORAL 11806354 April 11, 2036 ACUTE TREATMENT OF MIGRAINE
20MG;EQ 10MG BASE SYMBRAVO AXSOME N215431 Jan. 30, 2025 RX TABLET ORAL 11826370 April 11, 2036 ACUTE TREATMENT OF MIGRAINE
20MG;EQ 10MG BASE SYMBRAVO AXSOME N215431 Jan. 30, 2025 RX TABLET ORAL 11865117 April 11, 2036 ACUTE TREATMENT OF MIGRAINE
20MG;EQ 10MG BASE SYMBRAVO AXSOME N215431 Jan. 30, 2025 RX TABLET ORAL 11944683 April 11, 2036 ACUTE TREATMENT OF MIGRAINE
20MG;EQ 10MG BASE SYMBRAVO AXSOME N215431 Jan. 30, 2025 RX TABLET ORAL 12485176 April 11, 2036 REDUCING TMAX OF ORALLY ADMINISTERED MELOXICAM
20MG;EQ 10MG BASE SYMBRAVO AXSOME N215431 Jan. 30, 2025 RX TABLET ORAL 9821075 April 11, 2036 ACUTE TREATMENT OF MIGRAINE
200MG/7ML (29.25MG/ML);6MG/7ML (0.88MG/ML) ZYNRELEF KIT HERON THERAPS INC N211988 May 12, 2021 RX SOLUTION, EXTENDED RELEASE PERIARTICULAR 11844837 April 21, 2036 TREATMENT OF POSTSURGICAL PAIN PROVIDING ANALGESIA TO A PATIENT FOR UP TO 72 HOURS, FOR EXAMPLE, AFTER FOOT AND ANKLE, SMALL-TO-MEDIUM OPEN ABDOMINAL, AND LOWER EXTREMITY TOTAL JOINT ARTHROPLASTY SURGICAL PROCEDURES VIA 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 11844837 April 21, 2036 TREATMENT OF POSTSURGICAL PAIN PROVIDING ANALGESIA TO A PATIENT FOR UP TO 72 HOURS, FOR EXAMPLE, AFTER FOOT AND ANKLE, SMALL-TO-MEDIUM OPEN ABDOMINAL, AND LOWER EXTREMITY TOTAL JOINT ARTHROPLASTY SURGICAL PROCEDURES VIA 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 11844837 April 21, 2036 TREATMENT OF POSTSURGICAL PAIN PROVIDING ANALGESIA TO A PATIENT FOR UP TO 72 HOURS, FOR EXAMPLE, AFTER FOOT AND ANKLE, SMALL-TO-MEDIUM OPEN ABDOMINAL, AND LOWER EXTREMITY TOTAL JOINT ARTHROPLASTY SURGICAL PROCEDURES VIA 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 11844837 April 21, 2036 TREATMENT OF POSTSURGICAL PAIN PROVIDING ANALGESIA TO A PATIENT FOR UP TO 72 HOURS, FOR EXAMPLE, AFTER FOOT AND ANKLE, SMALL-TO-MEDIUM OPEN ABDOMINAL, AND LOWER EXTREMITY TOTAL JOINT ARTHROPLASTY SURGICAL PROCEDURES VIA INSTILLATION
20MG;EQ 10MG BASE SYMBRAVO AXSOME N215431 Jan. 30, 2025 RX TABLET ORAL 12472256 May 18, 2038 IMPROVING THE PHARMACOKINETICS OF MELOXICAM IN A HUMAN BEING SUFFERING FROM MIGRAINE
20MG;EQ 10MG BASE SYMBRAVO AXSOME N215431 Jan. 30, 2025 RX TABLET ORAL 12472257 May 18, 2038 RAPID DELIVERY OF MELOXICAM TO THE BLOOD OF A HUMAN BEING
20MG;EQ 10MG BASE SYMBRAVO AXSOME N215431 Jan. 30, 2025 RX TABLET ORAL 12616752 May 18, 2038 RAPID DELIVERY OF MELOXICAM TO THE BLOOD OF A HUMAN BEING FOR THE ACUTE TREATMENT OF MIGRAINE
30MG/ML (30MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** ANJESO BAUDAX N210583 Feb. 20, 2020 DISCN SOLUTION INTRAVENOUS 10881663 March 8, 2039 MANAGEMENT OF MODERATE-TO-SEVERE PAIN BY INTRAVENOUS INJECTION IN PATIENTS WITH MILD RENAL IMPAIRMENT
30MG/ML (30MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** ANJESO BAUDAX N210583 Feb. 20, 2020 DISCN SOLUTION INTRAVENOUS 11458145 March 8, 2039 MANAGEMENT OF MODERATE-TO-SEVERE PAIN BY INJECTION
20MG;EQ 10MG BASE SYMBRAVO AXSOME N215431 Jan. 30, 2025 RX TABLET ORAL 12128052 May 28, 2040 ACUTE TREATMENT OF MIGRAINE
20MG;EQ 10MG BASE SYMBRAVO AXSOME N215431 Jan. 30, 2025 RX TABLET ORAL 12551488 May 28, 2040 ACUTE TREATMENT OF MIGRAINE
20MG;EQ 10MG BASE SYMBRAVO AXSOME N215431 Jan. 30, 2025 RX TABLET ORAL 12551489 May 28, 2040 ACUTE TREATMENT OF MIGRAINE
20MG;EQ 10MG BASE SYMBRAVO AXSOME N215431 Jan. 30, 2025 RX TABLET ORAL 12370196 Dec. 29, 2041 ACUTE TREATMENT OF MIGRAINE
20MG;EQ 10MG BASE SYMBRAVO AXSOME N215431 Jan. 30, 2025 RX TABLET ORAL 12611413 Dec. 29, 2041 ACUTE TREATMENT OF MIGRAINE
20MG;EQ 10MG BASE SYMBRAVO AXSOME N215431 Jan. 30, 2025 RX TABLET ORAL 12005118 Jan. 25, 2043 ACUTE TREATMENT OF MIGRAINE
20MG;EQ 10MG BASE SYMBRAVO AXSOME N215431 Jan. 30, 2025 RX TABLET ORAL 12544383 March 10, 2045 ACUTE TREATMENT OF MIGRAINE

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
200MG/7ML (29.25MG/ML);6MG/7ML (0.88MG/ML) ZYNRELEF KIT HERON THERAPS INC N211988 May 12, 2021 RX SOLUTION, EXTENDED RELEASE PERIARTICULAR Jan. 23, 2027 REVISIONS TO THE LABELING TO EXPAND THE USE IN CERTAIN SOFT TISSUE AND CERTAIN ORTHOPEDIC SURGICAL PROCEDURES AS WELL AS REVISING THE LIMITATIONS OF USE
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 Jan. 23, 2027 REVISIONS TO THE LABELING TO EXPAND THE USE IN CERTAIN SOFT TISSUE AND CERTAIN ORTHOPEDIC SURGICAL PROCEDURES AS WELL AS REVISING THE LIMITATIONS OF USE
400MG/14ML (29.25MG/ML);12MG/14ML (0.88MG/ML) ZYNRELEF KIT HERON THERAPS INC N211988 May 12, 2021 RX SOLUTION, EXTENDED RELEASE PERIARTICULAR Jan. 23, 2027 REVISIONS TO THE LABELING TO EXPAND THE USE IN CERTAIN SOFT TISSUE AND CERTAIN ORTHOPEDIC SURGICAL PROCEDURES AS WELL AS REVISING THE LIMITATIONS OF USE
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 Jan. 23, 2027 REVISIONS TO THE LABELING TO EXPAND THE USE IN CERTAIN SOFT TISSUE AND CERTAIN ORTHOPEDIC SURGICAL PROCEDURES AS WELL AS REVISING THE LIMITATIONS OF USE
20MG;EQ 10MG BASE SYMBRAVO AXSOME N215431 Jan. 30, 2025 RX TABLET ORAL Jan. 30, 2028 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
VG2QF83CGL INXIGHT DRUGS

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Meloxicam HUMAN PRESCRIPTION DRUG LABEL 1 0440-5841 TABLET 7.50 mg ORAL ANDA 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 11788-098 TABLET 7.50 mg ORAL ANDA 20 sections
MELOXICAM HUMAN PRESCRIPTION DRUG LABEL 1 11788-099 TABLET 15 mg ORAL ANDA 20 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
XIFYRM Human Prescription Drug Label 1 24338-153 INJECTION 30 mg INTRAVENOUS NDA 27 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 31722-226 TABLET 7.50 mg ORAL ANDA 20 sections
MELOXICAM HUMAN PRESCRIPTION DRUG LABEL 1 31722-227 TABLET 15 mg ORAL ANDA 20 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
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
meloxicam HUMAN PRESCRIPTION DRUG LABEL 1 42708-007 TABLET 15 mg ORAL ANDA 27 sections
meloxicam HUMAN PRESCRIPTION DRUG LABEL 1 42708-093 TABLET 7.50 mg ORAL ANDA 27 sections