buprenorphine 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |

Stem definitionDrug idCAS RN
opioid receptor antagonists/agonists, morphinan derivates 434 52485-79-7

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • buprenorphine
  • buprenorfine
  • norspan
  • buprenorphine hydrochloride
  • buprenorphine HCl
A derivative of the opioid alkaloid THEBAINE that is a more potent and longer lasting analgesic than MORPHINE. It appears to act as a partial agonist at mu and kappa opioid receptors and as an antagonist at delta receptors. The lack of delta-agonist activity has been suggested to account for the observation that buprenorphine tolerance may not develop with chronic use.
  • Molecular weight: 467.65
  • Formula: C29H41NO4
  • CLOGP: 3.99
  • LIPINSKI: 0
  • HAC: 5
  • HDO: 2
  • TPSA: 62.16
  • ALOGS: -4.44
  • ROTB: 5
  • Status: OFP
    • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
1.20 mg P
1.20 mg SL
1.20 mg TD
1.60 mg implant
2.10 mg P
8 mg SL
8 mg SL

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 1 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 17 mg/mL Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 1 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 0.04 µM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 10 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution) 4.90 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 19 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.04 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 3.20 hours Lombardo F, Berellini G, Obach RS

Predicted pharmacokinetic/toxicological properties (PK-AZ):

PropertyDescriptionValueUnitConfidenceSimilarity
kinase-safety-class ACVR2B,AXL,BRAF,BTK,CAMK2B,CAMK2D,CDK4,CDK5,CDK9,EIF2AK3,ERBB2,GRK2,ITK,JAK3,MAPK10,MAPK7,NTRK2,PDK1,PDK2,PDK4,PRKDC,TEK,TGFBR1,ZAP70 24
kinase-selectivity-class EIF2AK3,GRK2 2
pfas-class PFAS structural alert (1 = True, 0 = False) 0

Approvals:

DateAgencyCompanyOrphan
June 19, 2019 EMA L. Molteni & C. dei Fratelli Alitti Società di Esercizio S.p.A.
Dec. 29, 1981 FDA RECKITT BENCKISER

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
Product adhesion issue 1447.85 13.09 436 103291 4706 90520014
Application site pruritus 1431.76 13.09 414 103313 3833 90520887
Drug withdrawal syndrome 1417.93 13.09 681 103046 28042 90496678
Application site erythema 977.01 13.09 324 103403 4884 90519836
Blepharospasm 806.03 13.09 597 103130 54848 90469872
Application site rash 784.55 13.09 234 103493 2435 90522285
Epilepsy 669.15 13.09 633 103094 81573 90443147
Taste disorder 611.05 13.09 530 103197 61016 90463704
Application site vesicles 592.87 13.09 166 103561 1351 90523369
Inadequate analgesia 574.58 13.09 193 103534 3031 90521689
Application site pain 535.12 13.09 202 103525 4518 90520202
Maternal exposure during pregnancy 525.95 13.09 1226 102501 358837 90165883
Breast cancer stage III 510.97 13.09 554 103173 83893 90440827
Back injury 490.25 13.09 415 103312 46207 90478513
Onychomadesis 484.81 13.09 410 103317 45588 90479132
Drug withdrawal syndrome neonatal 482.27 13.09 156 103571 2163 90522557
Application site burn 456.72 13.09 123 103604 851 90523869
Drug abuse 454.69 13.09 515 103212 81832 90442888
Nail disorder 430.09 13.09 428 103299 58639 90466081
Product quality issue 371.39 13.09 456 103271 78869 90445851
Facet joint syndrome 361.67 13.09 502 103225 97887 90426833
Gastrooesophageal reflux disease 351.98 13.09 660 103067 165677 90359043
Bursitis 330.60 13.09 563 103164 131091 90393629
Onychomycosis 317.72 13.09 295 103432 37081 90487639
Drug dependence 314.31 13.09 264 103463 29063 90495657
Peripheral venous disease 302.15 13.09 424 103303 83497 90441223
Application site irritation 297.23 13.09 104 103623 1857 90522863
Product label confusion 294.23 13.09 229 103498 22621 90502099
Substance abuse 293.62 13.09 137 103590 5269 90519451
Finger deformity 272.58 13.09 256 103471 32641 90492079
Withdrawal syndrome 271.24 13.09 217 103510 22307 90502413
Adverse reaction 269.08 13.09 243 103484 29469 90495251
Hypercholesterolaemia 265.93 13.09 441 103286 100451 90424269
Wound infection 265.72 13.09 454 103273 105948 90418772
Exposure during pregnancy 259.28 13.09 727 103000 237683 90287037
Live birth 257.45 13.09 381 103346 78726 90445994
Lip dry 241.93 13.09 423 103304 100532 90424188
Coeliac disease 230.97 13.09 270 103457 44340 90480380
Obesity 224.71 13.09 420 103307 105087 90419633
C-reactive protein increased 216.99 13.09 573 103154 180816 90343904
Pyrexia 212.23 13.09 267 103460 660218 89864502
Infusion site reaction 207.32 13.09 173 103554 18866 90505854
Application site scar 201.74 13.09 48 103679 184 90524536
Cough 193.69 13.09 90 103637 368872 90155848
Liver function test increased 192.29 13.09 347 103380 84508 90440212
Application site discharge 188.33 13.09 43 103684 131 90524589
Inflammation 185.66 13.09 536 103191 178056 90346664
Neck pain 181.28 13.09 402 103325 113561 90411159
Dry mouth 176.67 13.09 537 103190 183522 90341198
Type 2 diabetes mellitus 175.83 13.09 572 103155 202672 90322048
Application site erosion 170.15 13.09 41 103686 168 90524552
Night sweats 167.59 13.09 420 103307 128346 90396374
Grip strength decreased 166.15 13.09 343 103384 92233 90432487
Migraine 163.93 13.09 535 103192 189857 90334863
Joint range of motion decreased 161.64 13.09 428 103299 135215 90389505
Memory impairment 159.82 13.09 543 103184 196701 90328019
Psoriatic arthropathy 156.41 13.09 595 103132 227740 90296980
Application site exfoliation 153.50 13.09 44 103683 393 90524327
Folliculitis 151.25 13.09 546 103181 203807 90320913
Application site dryness 150.69 13.09 36 103691 141 90524579
Drug screen negative 150.11 13.09 41 103686 301 90524419
Intentional product use issue 150.05 13.09 567 103160 216325 90308395
Drug-induced liver injury 148.61 13.09 323 103404 89995 90434725
Injection site reaction 146.63 13.09 325 103402 91755 90432965
Lung disorder 143.52 13.09 437 103290 149446 90375274
Foetal exposure during pregnancy 141.23 13.09 208 103519 42767 90481953
Gait inability 140.22 13.09 427 103300 146029 90378691
Anaemia 137.36 13.09 121 103606 352681 90172039
Sinusitis 133.17 13.09 118 103609 342970 90181750
Hepatitis 131.54 13.09 266 103461 70473 90454247
Paraesthesia 130.48 13.09 600 103127 249726 90274994
Confusional state 129.43 13.09 820 102907 385385 90139335
Fibromyalgia 128.68 13.09 522 103205 205747 90318973
Fatigue 125.12 13.09 792 102935 1153231 89371489
Hypoaesthesia 124.40 13.09 697 103030 313513 90211207
Neutropenia 124.05 13.09 51 103676 224853 90299867
Blood cholesterol increased 123.92 13.09 519 103208 207493 90317227
Application site urticaria 122.69 13.09 33 103694 227 90524493
Application site discolouration 120.46 13.09 44 103683 894 90523826
Drug use disorder 119.25 13.09 89 103638 8254 90516466
Infection 118.56 13.09 144 103583 361950 90162770
Duodenal ulcer perforation 115.75 13.09 531 103196 220757 90303963
Haemoglobin decreased 112.43 13.09 24 103703 161932 90362788
Abdominal pain upper 111.81 13.09 707 103020 331967 90192753
White blood cell count decreased 111.53 13.09 27 103700 167082 90357638
Thrombocytopenia 110.87 13.09 50 103677 208675 90316045
Wrong technique in product usage process 109.88 13.09 249 103478 71322 90453398
Drug delivery system removal 109.71 13.09 19 103708 0 90524720
Osteoarthritis 108.60 13.09 478 103249 195252 90329468
Euphoric mood 108.42 13.09 71 103656 5338 90519382
Muscle injury 107.74 13.09 444 103283 176210 90348510
Liver injury 107.43 13.09 433 103294 170134 90354586
Disease progression 103.17 13.09 26 103701 156589 90368131
Febrile neutropenia 102.94 13.09 27 103700 158322 90366398
Platelet count decreased 102.09 13.09 17 103710 136952 90387768
Product dose omission issue 100.86 13.09 111 103616 291576 90233144
Helicobacter infection 100.43 13.09 519 103208 226331 90298389
Product solubility abnormal 100.18 13.09 39 103688 950 90523770
Urinary tract infection 99.55 13.09 122 103605 305510 90219210
Musculoskeletal pain 99.42 13.09 424 103303 170827 90353893
Acute kidney injury 99.07 13.09 133 103594 320254 90204466
Rheumatic fever 93.47 13.09 385 103342 152736 90371984
Blister 93.25 13.09 554 103173 254444 90270276
Diarrhoea 92.37 13.09 663 103064 938527 89586193
Application site reaction 92.19 13.09 35 103692 795 90523925
Anti-cyclic citrullinated peptide antibody positive 91.21 13.09 521 103206 235912 90288808
Application site swelling 89.26 13.09 32 103695 615 90524105
Depression 88.38 13.09 618 103109 299983 90224737
Overdose 88.10 13.09 386 103341 157323 90367397
Abdominal distension 87.42 13.09 338 103389 130263 90394457
Influenza 86.33 13.09 26 103701 139238 90385482
Erythema 85.16 13.09 82 103645 229164 90295556
Product packaging quantity issue 85.15 13.09 40 103687 1562 90523158
Product administered at inappropriate site 84.46 13.09 55 103672 4096 90520624
Irritable bowel syndrome 82.56 13.09 461 103266 206987 90317733
COVID-19 81.33 13.09 46 103681 168797 90355923
Pancytopenia 81.09 13.09 19 103708 120244 90404476
Pericarditis 80.93 13.09 558 103169 269593 90255127
Hyperaesthesia 80.53 13.09 79 103648 10623 90514097
Pruritus 79.69 13.09 334 103393 541191 89983529
Overlap syndrome 79.52 13.09 71 103656 8477 90516243
Drug screen positive 79.44 13.09 51 103676 3706 90521014
Weight decreased 78.22 13.09 202 103525 379708 90145012
Sleep disorder 76.77 13.09 437 103290 197593 90327127
Dyspnoea 76.67 13.09 643 103084 880312 89644408
Placental hypertrophy 75.85 13.09 14 103713 6 90524714
Placental disorder 75.82 13.09 37 103690 1574 90523146
Product physical issue 75.63 13.09 58 103669 5602 90519118
General physical health deterioration 75.22 13.09 677 103050 354438 90170282
Premature delivery 73.52 13.09 147 103580 38615 90486105
Muscle spasms 70.61 13.09 512 103215 251371 90273349
Drug detoxification 70.30 13.09 23 103704 331 90524389
Hepatic enzyme 69.74 13.09 54 103673 5290 90519430
Yawning 69.26 13.09 31 103696 1081 90523639
Application site dermatitis 69.03 13.09 19 103708 144 90524576
Blood pressure increased 67.10 13.09 76 103651 197141 90327579
Impaired healing 65.60 13.09 476 103251 233723 90290997
Injection site infection 65.60 13.09 38 103689 2294 90522426
Interstitial lung disease 65.40 13.09 6 103721 76399 90448321
Hypocholesterolaemia 64.87 13.09 56 103671 6393 90518327
Normal newborn 64.03 13.09 104 103623 23258 90501462
Application site ulcer 63.81 13.09 16 103711 80 90524640
Neuropathy peripheral 63.58 13.09 39 103688 136931 90387789
Jaundice neonatal 62.40 13.09 28 103699 982 90523738
Muscular weakness 61.93 13.09 427 103300 206239 90318481
Therapeutic product effect increased 61.63 13.09 30 103697 1269 90523451
Incorrect product administration duration 61.29 13.09 92 103635 19230 90505490
Oral administration complication 61.08 13.09 16 103711 98 90524622
Chest discomfort 59.37 13.09 43 103684 138322 90386398
Sepsis 59.33 13.09 71 103656 179743 90344977
Therapeutic product effect decreased 58.14 13.09 528 103199 277043 90247677
C-reactive protein abnormal 58.05 13.09 294 103433 127135 90397585
Arthritis 57.43 13.09 64 103663 167251 90357469
Respiratory depression 56.46 13.09 79 103648 15496 90509224
Bronchitis 56.43 13.09 55 103672 152872 90371848
Myalgia 55.83 13.09 71 103656 175054 90349666
Rhesus incompatibility 55.79 13.09 15 103712 103 90524617
Lower respiratory tract infection 55.68 13.09 483 103244 250176 90274544
Aspartate aminotransferase increased 55.67 13.09 24 103703 102913 90421807
Wheezing 55.65 13.09 464 103263 237616 90287104
Hypotension 55.39 13.09 189 103538 325208 90199512
Wound 54.43 13.09 558 103169 302422 90222298
Dyspnoea exertional 53.80 13.09 9 103718 72279 90452441
Stomatitis 53.75 13.09 515 103212 274183 90250537
Therapeutic product effect incomplete 53.09 13.09 392 103335 193504 90331216
Neutrophil count decreased 53.03 13.09 9 103718 71523 90453197
Application site scab 52.99 13.09 16 103711 174 90524546
Productive cough 52.29 13.09 12 103715 77051 90447669
Glossodynia 51.92 13.09 580 103147 321199 90203521
Pulmonary embolism 51.90 13.09 44 103683 130776 90393944
Cataract 51.43 13.09 10 103717 72082 90452638
Blood glucose increased 50.26 13.09 23 103704 95223 90429497
Dehydration 50.25 13.09 91 103636 194356 90330364
Herpes zoster 49.72 13.09 23 103704 94621 90430099
Myelosuppression 49.30 13.09 3 103724 53588 90471132
Accidental exposure to product by child 49.26 13.09 26 103701 1307 90523413
Nasal congestion 49.16 13.09 17 103710 83397 90441323
Pemphigus 48.20 13.09 579 103148 326285 90198435
Myocardial infarction 48.04 13.09 31 103696 105941 90418779
Exposure via breast milk 47.90 13.09 31 103696 2284 90522436
Oropharyngeal pain 47.87 13.09 37 103690 115150 90409570
Hand deformity 47.72 13.09 534 103193 295828 90228892
Underdose 47.50 13.09 153 103574 53864 90470856
Psoriasis 46.99 13.09 60 103667 147694 90377026
Pleural effusion 46.50 13.09 36 103691 111955 90412765
Alcohol abuse 46.49 13.09 29 103698 2004 90522716
Chest pain 46.42 13.09 198 103529 319447 90205273
Selective abortion 46.31 13.09 14 103713 153 90524567
Leukopenia 46.28 13.09 29 103698 100681 90424039
Injection site cellulitis 46.04 13.09 26 103701 1495 90523225
Blood creatinine increased 45.49 13.09 30 103697 101356 90423364
Alanine aminotransferase increased 45.49 13.09 41 103686 118297 90406423
Breakthrough pain 45.17 13.09 25 103702 1382 90523338
Malignant neoplasm progression 44.83 13.09 34 103693 106836 90417884
Abortion spontaneous 44.75 13.09 150 103577 53906 90470814
Congenital anomaly 44.34 13.09 45 103682 6302 90518418
Substance use disorder 44.15 13.09 28 103699 1992 90522728
Upper respiratory tract infection 44.12 13.09 49 103678 128269 90396451
Rheumatoid arthritis 43.28 13.09 618 103109 361996 90162724
Respiratory failure 43.21 13.09 43 103684 118375 90406345
Dry skin 42.39 13.09 24 103703 88049 90436671
Diabetes mellitus 42.27 13.09 11 103716 64864 90459856
Product dispensing issue 42.24 13.09 17 103710 453 90524267
Product physical consistency issue 42.18 13.09 21 103706 933 90523787
Back pain 42.15 13.09 203 103524 316972 90207748
Colitis 41.66 13.09 14 103713 69928 90454792
Injury 41.60 13.09 376 103351 196973 90327747
Maternal exposure during breast feeding 41.46 13.09 43 103684 6177 90518543
Injection site necrosis 41.01 13.09 24 103703 1477 90523243
Cardiac failure congestive 40.63 13.09 32 103695 98662 90426058
Cerebrovascular accident 40.50 13.09 49 103678 123484 90401236
Intentional misuse of drug delivery system 40.42 13.09 7 103720 0 90524720
Sleep disorder due to general medical condition, insomnia type 40.16 13.09 53 103674 128641 90396079
Dyspepsia 39.98 13.09 374 103353 197786 90326934
Pneumonitis 39.09 13.09 3 103724 44167 90480553
Headache 38.79 13.09 725 103002 862021 89662699
Drug ineffective 38.61 13.09 1250 102477 1383048 89141672
Ill-defined disorder 38.32 13.09 351 103376 184540 90340180
Synovitis 38.15 13.09 559 103168 329193 90195527
Renal failure 37.85 13.09 57 103670 130950 90393770
Neurosis 37.62 13.09 15 103712 390 90524330
Haematochezia 37.61 13.09 17 103710 70896 90453824
Gastrointestinal haemorrhage 37.48 13.09 29 103698 90219 90434501
Rhinorrhoea 37.16 13.09 28 103699 88288 90436432
Viral infection 36.13 13.09 3 103724 41411 90483309
Injection site extravasation 36.10 13.09 48 103679 8971 90515749
Multiple sclerosis relapse 35.78 13.09 8 103719 52297 90472423
Chills 35.70 13.09 60 103667 131921 90392799
Breast cancer stage II 35.64 13.09 105 103622 35229 90489491
Mucosal inflammation 35.27 13.09 11 103716 57614 90467106
Subchondral insufficiency fracture 35.25 13.09 9 103718 49 90524671
Diverticulitis 35.05 13.09 5 103722 45182 90479538
Gait disturbance 35.02 13.09 166 103561 260330 90264390
Septic shock 35.01 13.09 27 103700 84133 90440587
Atrial fibrillation 34.99 13.09 62 103665 133549 90391171
Injection site erosion 34.92 13.09 10 103717 89 90524631
17 ketosteroids urine abnormal 34.64 13.09 6 103721 0 90524720
Mobility decreased 34.28 13.09 438 103289 250296 90274424
Abortion induced 34.05 13.09 54 103673 11834 90512886
Defaecation disorder 33.99 13.09 18 103709 911 90523809
Cystitis 33.84 13.09 17 103710 66701 90458019
Systemic lupus erythematosus 33.79 13.09 592 103135 361304 90163416
Injection site ulcer 33.54 13.09 16 103711 647 90524073
Application site odour 33.16 13.09 8 103719 33 90524687
Foetal growth restriction 33.14 13.09 47 103680 9333 90515387
Blood pressure decreased 32.48 13.09 23 103704 74872 90449848
Hypokalaemia 32.42 13.09 63 103664 131053 90393667
Throat irritation 32.22 13.09 8 103719 48687 90476033
Influenza like illness 32.11 13.09 27 103700 80584 90444136
Red blood cell count decreased 31.88 13.09 7 103720 46344 90478376
Therapy interrupted 31.69 13.09 9 103718 50099 90474621
Flushing 31.30 13.09 33 103694 88458 90436262
Cardiac disorder 31.16 13.09 13 103714 56859 90467861
Thrombosis 31.11 13.09 23 103704 73228 90451492
Multiple organ dysfunction syndrome 30.96 13.09 20 103707 68316 90456404
Hyponatraemia 30.62 13.09 67 103660 133471 90391249
Application site induration 30.49 13.09 6 103721 6 90524714
Accidental overdose 30.43 13.09 86 103641 28187 90496533
Urticaria 30.42 13.09 515 103212 312219 90212501
Drug reaction with eosinophilia and systemic symptoms 30.35 13.09 6 103721 42752 90481968
Congenital coronary artery malformation 30.25 13.09 10 103717 149 90524571
Application site haemorrhage 30.18 13.09 18 103709 1147 90523573
Heart rate increased 29.91 13.09 52 103675 112850 90411870
Victim of sexual abuse 29.85 13.09 15 103712 680 90524040
Dysphagia 29.49 13.09 52 103675 112226 90412494
Somnolence 29.32 13.09 367 103360 208717 90316003
Drug diversion 29.29 13.09 17 103710 1030 90523690
Product use in unapproved indication 29.26 13.09 544 103183 335692 90189028
Abdominal pain 29.04 13.09 301 103426 395420 90129300
Dry eye 29.02 13.09 15 103712 57916 90466804
Rheumatoid factor positive 28.98 13.09 100 103627 171550 90353170
Injection site abscess 28.93 13.09 19 103708 1435 90523285
Epistaxis 28.72 13.09 33 103694 85092 90439628
Full blood count abnormal 28.50 13.09 4 103723 36593 90488127
Drug intolerance 28.23 13.09 691 103036 446900 90077820
Clostridium difficile infection 28.13 13.09 4 103723 36241 90488479
Hyperkalaemia 28.11 13.09 20 103707 64944 90459776
Therapy naive 28.08 13.09 7 103720 34 90524686
Coronary artery disease 27.83 13.09 3 103724 33620 90491100
Hypothyroidism 27.76 13.09 13 103714 53114 90471606
Ascites 27.67 13.09 10 103717 47730 90476990
Hepatotoxicity 27.61 13.09 9 103718 45833 90478887
Basal cell carcinoma 27.59 13.09 3 103724 33386 90491334
Echocardiogram abnormal 27.29 13.09 19 103708 1580 90523140
Impaired reasoning 27.11 13.09 9 103718 136 90524584
Poor feeding infant 27.04 13.09 13 103714 535 90524185
Maternal use of illicit drugs 26.87 13.09 6 103721 16 90524704
Vision blurred 26.41 13.09 54 103673 110239 90414481
Bradycardia foetal 26.38 13.09 13 103714 565 90524155
Sinus disorder 26.28 13.09 4 103723 34443 90490277
Eye pain 26.03 13.09 9 103718 44159 90480561
Oxygen saturation decreased 25.41 13.09 53 103674 107430 90417290
Anaphylactic reaction 25.36 13.09 38 103689 87486 90437234
Disease recurrence 25.27 13.09 6 103721 37647 90487073
Intentional underdose 25.21 13.09 20 103707 2029 90522691
Application site inflammation 24.86 13.09 11 103716 373 90524347
Lymphocyte count decreased 24.71 13.09 5 103722 35045 90489675
Ulcer 24.67 13.09 4 103723 32878 90491842
Hepatic steatosis 24.58 13.09 6 103721 36939 90487781
Central pain syndrome 24.56 13.09 13 103714 657 90524063
Rash erythematous 24.49 13.09 23 103704 65081 90459639
Pericardial effusion 24.47 13.09 6 103721 36827 90487893
Prescription drug used without a prescription 24.44 13.09 24 103703 3231 90521489
Intentional product misuse 24.41 13.09 181 103546 89423 90435297
Haemorrhage 24.38 13.09 26 103701 69343 90455377
Pain 24.37 13.09 914 102813 995427 89529293
Miosis 24.35 13.09 41 103686 9443 90515277
Contusion 24.23 13.09 178 103549 251038 90273682
Blood calcium decreased 24.22 13.09 3 103724 30179 90494541
Bone marrow failure 24.00 13.09 4 103723 32217 90492503
Foot deformity 23.73 13.09 20 103707 59631 90465089
Expulsion of medication 23.61 13.09 6 103721 32 90524688
Application site papules 23.54 13.09 7 103720 72 90524648
Cellulitis 23.36 13.09 43 103684 91294 90433426
Skin exfoliation 23.27 13.09 26 103701 67887 90456833
Eczema 23.24 13.09 16 103711 52854 90471866
Fungal infection 22.98 13.09 10 103717 42651 90482069
Blood potassium decreased 22.97 13.09 13 103714 47714 90477006
Pulmonary hypertension 22.85 13.09 10 103717 42513 90482207
Pulmonary mass 22.75 13.09 3 103724 28769 90495951
Lymphadenopathy 22.71 13.09 12 103715 45763 90478957
Syncope 22.58 13.09 77 103650 132586 90392134
Application site bruise 22.09 13.09 10 103717 358 90524362
Immunodeficiency 21.95 13.09 11 103716 43223 90481497
Cytokine release syndrome 21.92 13.09 3 103724 27970 90496750
Blood alkaline phosphatase increased 21.87 13.09 14 103713 48065 90476655
Body temperature increased 21.78 13.09 12 103715 44698 90480022
Oedema 21.76 13.09 137 103590 200158 90324562
Asthma 21.74 13.09 175 103552 241985 90282735
Hypophagia 21.74 13.09 7 103720 35930 90488790
Dysgeusia 21.68 13.09 17 103710 52543 90472177
Persistent depressive disorder 21.60 13.09 15 103712 1242 90523478
Chemical submission 21.48 13.09 11 103716 519 90524201
Arthropathy 21.47 13.09 560 103167 365682 90159038
Neonatal respiratory distress 21.46 13.09 12 103715 677 90524043
Skin discolouration 21.43 13.09 12 103715 44303 90480417
Rash maculo-papular 21.41 13.09 10 103717 40923 90483797
Nephrolithiasis 21.38 13.09 15 103712 49070 90475650
Respiratory tract congestion 21.33 13.09 3 103724 27407 90497313
Drug eruption 21.24 13.09 7 103720 35400 90489320
Stress 21.10 13.09 38 103689 81357 90443363
Haemoptysis 21.04 13.09 6 103721 33314 90491406
Angioedema 20.98 13.09 26 103701 64850 90459870
Hepatitis C 20.95 13.09 29 103698 5631 90519089
Application site perspiration 20.85 13.09 5 103722 20 90524700
Pain in jaw 20.46 13.09 15 103712 47970 90476750
Cholelithiasis 20.40 13.09 18 103709 52488 90472232
Breast cancer 20.21 13.09 19 103708 53742 90470978
Contraindicated product administered 20.09 13.09 494 103233 319645 90205075
Eye irritation 19.89 13.09 7 103720 33971 90490749
Plasma cell myeloma 19.82 13.09 11 103716 40817 90483903
Hypersensitivity 19.77 13.09 384 103343 454293 90070427
Hypomagnesaemia 19.72 13.09 8 103719 35580 90489140
Cardiac failure 19.71 13.09 62 103665 109434 90415286
Colitis ulcerative 19.65 13.09 24 103703 60242 90464478
Device dislocation 19.28 13.09 6 103721 31476 90493244
Low birth weight baby 19.28 13.09 37 103690 9430 90515290
Bradycardia 19.27 13.09 42 103685 83805 90440915
Tubulointerstitial nephritis 19.20 13.09 3 103724 25340 90499380
Agranulocytosis 19.18 13.09 8 103719 34994 90489726
Vulvar basal cell carcinoma 19.17 13.09 5 103722 30 90524690
Ulcer haemorrhage 19.15 13.09 70 103657 26251 90498469
Hepatic failure 18.87 13.09 11 103716 39717 90485003
Premature separation of placenta 18.83 13.09 18 103709 2344 90522376
Respiratory tract infection 18.77 13.09 24 103703 59054 90465666
Hepatic cytolysis 18.74 13.09 6 103721 30910 90493810
Eyelid retraction 18.62 13.09 6 103721 82 90524638
Candida infection 18.32 13.09 8 103719 34049 90490671
Tooth hypoplasia 18.30 13.09 6 103721 87 90524633
Transaminases increased 18.09 13.09 10 103717 37182 90487538
Illness 18.08 13.09 42 103685 81927 90442793
Abdominal pain lower 18.04 13.09 6 103721 30171 90494549
Visual impairment 17.98 13.09 84 103643 132281 90392439
Fluid retention 17.97 13.09 47 103680 88044 90436676
Pulmonary arterial hypertension 17.92 13.09 4 103723 26183 90498537
Muscle spasticity 17.91 13.09 9 103718 35313 90489407
Palpitations 17.86 13.09 88 103639 136640 90388080
Deep vein thrombosis 17.85 13.09 50 103677 91570 90433150
Therapy non-responder 17.84 13.09 88 103639 136616 90388104
Oral herpes 17.83 13.09 8 103719 33516 90491204
Stress cardiomyopathy 17.81 13.09 44 103683 13311 90511409
Chronic sinusitis 17.63 13.09 3 103724 23799 90500921
Foetal malformation 17.53 13.09 8 103719 292 90524428
Acute myocardial infarction 17.53 13.09 9 103718 34881 90489839
Sinus arrhythmia 17.52 13.09 14 103713 1435 90523285
Device related infection 17.52 13.09 4 103723 25782 90498938
Hip fracture 17.43 13.09 8 103719 33069 90491651
Product colour issue 17.36 13.09 11 103716 781 90523939
Gamma-glutamyltransferase increased 17.34 13.09 11 103716 37941 90486779
Endocarditis staphylococcal 17.32 13.09 9 103718 438 90524282
Product use issue 17.22 13.09 497 103230 329422 90195298
Incorrect route of product administration 17.20 13.09 108 103619 50518 90474202
Application site infection 16.94 13.09 5 103722 50 90524670
Bone pain 16.92 13.09 28 103699 61955 90462765
Hepatocellular injury 16.89 13.09 6 103721 28952 90495768
Hypoxia 16.86 13.09 36 103691 72363 90452357
Inappropriate schedule of product administration 16.85 13.09 253 103474 149680 90375040
Somnolence neonatal 16.80 13.09 6 103721 114 90524606
Osmotic demyelination syndrome 16.78 13.09 12 103715 1042 90523678
Blood bilirubin increased 16.77 13.09 15 103712 43455 90481265
Drug resistance 16.62 13.09 7 103720 30442 90494278
Gastritis 16.61 13.09 14 103713 41739 90482981
Gastroenteritis viral 16.53 13.09 7 103720 30348 90494372
Clostridium difficile colitis 16.52 13.09 5 103722 26701 90498019
Oesophageal motility disorder 16.50 13.09 10 103717 656 90524064
Eosinophilia 16.50 13.09 6 103721 28527 90496193
Drug ineffective for unapproved indication 16.49 13.09 32 103695 66612 90458108
Acute respiratory failure 16.33 13.09 15 103712 42903 90481817
Flatulence 16.29 13.09 14 103713 41353 90483367
Skin irritation 16.26 13.09 43 103684 13560 90511160
Judgement impaired 16.25 13.09 11 103716 874 90523846
Chronic obstructive pulmonary disease 16.14 13.09 38 103689 73791 90450929
Bronchiectasis 16.13 13.09 3 103724 22327 90502393
Hot flush 16.12 13.09 27 103700 59461 90465259
Staphylococcal infection 16.10 13.09 19 103708 48420 90476300
Limb discomfort 16.10 13.09 12 103715 38048 90486672
Osteonecrosis 16.07 13.09 5 103722 26236 90498484
Pneumonia 16.07 13.09 583 103144 637476 89887244
Psychomotor skills impaired 15.90 13.09 18 103709 2854 90521866
Pollakiuria 15.87 13.09 9 103718 32996 90491724
Hypoacusis 15.86 13.09 6 103721 27844 90496876
Hanging 15.79 13.09 4 103723 21 90524699
Pharyngitis 15.75 13.09 3 103724 21944 90502776
Neonatal aspiration 15.65 13.09 6 103721 140 90524580
Blood sodium decreased 15.64 13.09 6 103721 27607 90497113
Device leakage 15.59 13.09 35 103692 9956 90514764
Product contamination 15.53 13.09 12 103715 1172 90523548
Rectal haemorrhage 15.50 13.09 46 103681 82698 90442022
Accidental poisoning 15.44 13.09 11 103716 949 90523771
Eye disorder 15.43 13.09 6 103721 27384 90497336
Mental status changes 15.42 13.09 17 103710 44662 90480058
Balance disorder 15.42 13.09 58 103669 97022 90427698
Injection site discharge 15.41 13.09 13 103714 1438 90523282
Genitourinary symptom 15.38 13.09 6 103721 147 90524573
Transient ischaemic attack 15.38 13.09 16 103711 43160 90481560
Physical abuse 15.34 13.09 4 103723 24 90524696
White blood cell count increased 15.19 13.09 34 103693 67207 90457513
Visual acuity reduced 15.19 13.09 4 103723 23406 90501314
Ear infection 15.19 13.09 36 103691 69739 90454981
Tendonitis 15.17 13.09 3 103724 21369 90503351
Injection site oedema 15.14 13.09 14 103713 1749 90522971
Application site pustules 14.94 13.09 4 103723 27 90524693
Bone disorder 14.91 13.09 4 103723 23116 90501604
Tremor neonatal 14.91 13.09 6 103721 160 90524560
Acne 14.86 13.09 7 103720 28500 90496220
Arthralgia 14.85 13.09 734 102993 777788 89746932
Gastric disorder 14.81 13.09 10 103717 33374 90491346
Hepatic enzyme increased 14.80 13.09 528 103199 360208 90164512
Osteopenia 14.79 13.09 4 103723 22998 90501722
Nodule 14.78 13.09 6 103721 26680 90498040
Myelodysplastic syndrome 14.70 13.09 3 103724 20900 90503820
Conversion disorder 14.60 13.09 15 103712 2131 90522589
Eating disorder 14.47 13.09 7 103720 28066 90496654
Cerebral haemorrhage 14.45 13.09 11 103716 34511 90490209
Dizziness 14.40 13.09 818 102909 588466 89936254
Knee arthroplasty 14.34 13.09 48 103679 83134 90441586
Toxicity to various agents 14.30 13.09 431 103296 287415 90237305
Skin lesion 14.29 13.09 13 103714 37352 90487368
Dermatitis contact 14.29 13.09 41 103686 13554 90511166
Lung neoplasm malignant 14.21 13.09 5 103722 24268 90500452
Joint injury 14.20 13.09 10 103717 32654 90492066
Substance dependence 14.18 13.09 6 103721 182 90524538
Dysphonia 14.17 13.09 32 103695 63052 90461668
Oral candidiasis 13.96 13.09 12 103715 35443 90489277
Eye pruritus 13.84 13.09 8 103719 29019 90495701
Rash pruritic 13.80 13.09 48 103679 82166 90442554
Oedema peripheral 13.72 13.09 210 103517 257705 90267015
Pancreatitis 13.68 13.09 38 103689 69788 90454932
Renal impairment 13.68 13.09 68 103659 105353 90419367
Liver disorder 13.66 13.09 82 103645 121187 90403533
Bacterial infection 13.43 13.09 5 103722 23439 90501281
Rash 13.41 13.09 760 102967 795340 89729380
Enlarged uvula 13.33 13.09 6 103721 212 90524508
Face oedema 13.32 13.09 5 103722 23313 90501407
Vaginal discharge 13.26 13.09 3 103724 19461 90505259
Drug level fluctuating 13.26 13.09 8 103719 521 90524199
Skin haemorrhage 13.23 13.09 4 103723 21376 90503344
Rhabdomyolysis 13.22 13.09 24 103703 51232 90473488
Neonatal pneumonia 13.21 13.09 4 103723 44 90524676
Neoplasm progression 13.19 13.09 19 103708 44467 90480253

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
Drug abuse 2626.31 14.63 1503 41174 103268 42475390
Drug withdrawal syndrome 2272.73 14.63 842 41835 20707 42557951
Drug dependence 1358.49 14.63 636 42041 28458 42550200
Miosis 828.01 14.63 357 42320 13089 42565569
Toxicity to various agents 815.39 14.63 1070 41607 228066 42350592
Intentional product misuse 806.98 14.63 591 42086 61309 42517349
Substance abuse 792.96 14.63 308 42369 8597 42570061
Drug use disorder 704.65 14.63 295 42382 10038 42568620
Drug withdrawal syndrome neonatal 673.70 14.63 228 42449 4233 42574425
Withdrawal syndrome 606.57 14.63 296 42381 14479 42564179
Product adhesion issue 574.39 14.63 162 42515 1577 42577081
Injection site pain 430.59 14.63 399 42278 57399 42521259
Application site pruritus 375.50 14.63 114 42563 1464 42577194
Overdose 357.79 14.63 482 42195 104782 42473876
Coma 316.89 14.63 326 42351 53228 42525430
Substance use disorder 303.08 14.63 134 42543 5211 42573447
Inadequate analgesia 300.21 14.63 115 42562 3082 42575576
Application site erythema 290.99 14.63 106 42571 2460 42576198
Application site rash 288.42 14.63 84 42593 925 42577733
Respiratory depression 256.31 14.63 185 42492 18683 42559975
Drug screen negative 255.16 14.63 56 42621 161 42578497
Alcohol abuse 253.97 14.63 109 42568 3940 42574718
Injection site infection 249.43 14.63 77 42600 1049 42577609
Drug delivery system removal 248.13 14.63 42 42635 0 42578658
Asphyxia 246.66 14.63 134 42543 8192 42570466
Injection site abscess 234.65 14.63 72 42605 960 42577698
Intentional product use issue 231.81 14.63 321 42356 71512 42507146
Foetal exposure during pregnancy 228.88 14.63 259 42418 47052 42531606
Somnolence 225.48 14.63 460 42217 140645 42438013
Drug detoxification 222.08 14.63 56 42621 337 42578321
Injection site ulcer 212.33 14.63 54 42623 338 42578320
Application site burn 207.94 14.63 48 42629 185 42578473
Drug screen positive 185.28 14.63 88 42589 4043 42574615
Myelopathy 185.18 14.63 79 42598 2812 42575846
Injection site necrosis 184.72 14.63 53 42624 551 42578107
Injection site erythema 177.05 14.63 153 42524 20042 42558616
Death 171.99 14.63 925 41752 470260 42108398
Agitation 169.11 14.63 261 42416 64053 42514605
Application site vesicles 156.84 14.63 48 42629 634 42578024
Wrong technique in product usage process 156.52 14.63 203 42474 42432 42536226
Brain oedema 149.85 14.63 127 42550 16200 42562458
Aggression 147.85 14.63 201 42476 43962 42534696
Application site pain 147.05 14.63 63 42614 2266 42576392
Euphoric mood 145.74 14.63 87 42590 6366 42572292
Bradypnoea 145.01 14.63 76 42601 4317 42574341
Febrile neutropenia 144.20 14.63 11 42666 185692 42392966
Injection site erosion 136.74 14.63 31 42646 108 42578550
Injection site cellulitis 128.55 14.63 41 42636 625 42578033
Accidental overdose 123.38 14.63 147 42530 28183 42550475
Jaundice neonatal 121.49 14.63 54 42623 2125 42576533
Accidental poisoning 108.84 14.63 43 42634 1253 42577405
Pyrexia 107.17 14.63 143 42534 393899 42184759
Maternal exposure during breast feeding 104.60 14.63 44 42633 1511 42577147
Application site irritation 104.56 14.63 36 42641 704 42577954
Drug diversion 101.68 14.63 38 42639 949 42577709
Poisoning 100.70 14.63 97 42580 14602 42564056
Diarrhoea 98.46 14.63 196 42481 460653 42118005
Poor feeding infant 96.27 14.63 35 42642 807 42577851
Exposure via breast milk 93.77 14.63 47 42630 2430 42576228
Substance use 93.17 14.63 42 42635 1709 42576949
Compartment syndrome 92.06 14.63 51 42626 3238 42575420
Injection site extravasation 91.76 14.63 50 42627 3072 42575586
Pneumonia 88.87 14.63 181 42496 421968 42156690
Inappropriate schedule of product administration 87.44 14.63 252 42425 95650 42483008
Cough 83.38 14.63 37 42640 178066 42400592
Restlessness 82.90 14.63 123 42554 29126 42549532
Pulmonary oedema 82.88 14.63 172 42505 53100 42525558
Hyperhidrosis 80.74 14.63 236 42441 90276 42488382
Neutropenia 80.72 14.63 50 42627 199381 42379277
Depressed level of consciousness 80.71 14.63 160 42517 47810 42530848
Impaired driving ability 80.46 14.63 45 42632 2910 42575748
Hallucination 77.27 14.63 175 42502 57332 42521326
Dysarthria 77.12 14.63 141 42536 39666 42538992
Platelet count decreased 76.40 14.63 22 42655 138559 42440099
Logorrhoea 74.41 14.63 42 42635 2765 42575893
Intentional removal of drug delivery system by patient 74.10 14.63 13 42664 3 42578655
Substance dependence 73.76 14.63 27 42650 635 42578023
Application site reaction 73.72 14.63 24 42653 392 42578266
Disease progression 73.53 14.63 26 42651 143630 42435028
Prescription drug used without a prescription 72.78 14.63 41 42636 2689 42575969
Visceral congestion 71.33 14.63 29 42648 912 42577746
Dependence 70.90 14.63 33 42644 1447 42577211
Brachial artery entrapment syndrome 70.89 14.63 12 42665 0 42578658
Product administered at inappropriate site 70.56 14.63 42 42635 3056 42575602
Quadriparesis 70.08 14.63 38 42639 2312 42576346
Accidental exposure to product by child 69.10 14.63 33 42644 1534 42577124
White blood cell count decreased 65.69 14.63 15 42662 110381 42468277
Injection site discharge 64.44 14.63 23 42654 502 42578156
Cluster headache 62.91 14.63 23 42654 539 42578119
Rhabdomyolysis 62.58 14.63 196 42481 77823 42500835
Altered state of consciousness 62.27 14.63 108 42569 29151 42549507
COVID-19 61.03 14.63 20 42657 115928 42462730
Spinal shock 59.32 14.63 13 42664 37 42578621
Atrial fibrillation 59.27 14.63 33 42644 139560 42439098
Drug interaction 59.07 14.63 463 42214 266536 42312122
Anaemia 59.00 14.63 120 42557 280158 42298500
Hepatitis C 58.60 14.63 61 42616 10072 42568586
Hypotension 57.08 14.63 107 42570 257524 42321134
Expulsion of medication 55.54 14.63 13 42664 54 42578604
Application site dryness 54.86 14.63 14 42663 89 42578569
Neurodegenerative disorder 53.61 14.63 19 42658 406 42578252
Therapeutic response shortened 53.58 14.63 67 42610 13487 42565171
Application site urticaria 53.41 14.63 13 42664 66 42578592
Acute kidney injury 53.35 14.63 189 42488 367148 42211510
Poisoning deliberate 53.28 14.63 58 42619 10076 42568582
Injection site warmth 52.47 14.63 33 42644 2650 42576008
Incorrect route of product administration 52.09 14.63 90 42587 24215 42554443
Thrombocytopenia 51.62 14.63 69 42608 190210 42388448
Disorientation 51.40 14.63 113 42564 36276 42542382
Premature baby 51.29 14.63 87 42590 23066 42555592
Off label use 50.95 14.63 403 42274 637932 41940726
Product solubility abnormal 50.58 14.63 20 42657 584 42578074
Injection site irritation 49.88 14.63 27 42650 1637 42577021
Injection site vesicles 49.83 14.63 25 42652 1295 42577363
Haemoglobin decreased 49.80 14.63 36 42641 132435 42446223
Dyspnoea 49.36 14.63 252 42425 442369 42136289
Anxiety 49.25 14.63 242 42435 118318 42460340
Injection site swelling 48.98 14.63 72 42605 16901 42561757
Drug abuser 48.78 14.63 35 42642 3496 42575162
Injection site pruritus 48.01 14.63 53 42624 9352 42569306
Injection site inflammation 47.49 14.63 23 42654 1103 42577555
Dermo-hypodermitis 47.40 14.63 20 42657 692 42577966
Persecutory delusion 46.22 14.63 34 42643 3530 42575128
Rash 46.10 14.63 134 42543 276820 42301838
Interstitial lung disease 45.99 14.63 11 42666 78451 42500207
Application site swelling 45.76 14.63 16 42661 328 42578330
Thrombosis 45.67 14.63 7 42670 68504 42510154
Respiratory arrest 45.63 14.63 93 42584 28331 42550327
Yawning 45.59 14.63 20 42657 762 42577896
Malignant neoplasm progression 45.47 14.63 26 42651 108374 42470284
Fatigue 45.24 14.63 254 42423 435387 42143271
Arthralgia 44.76 14.63 86 42591 205152 42373506
Deafness neurosensory 44.71 14.63 34 42643 3712 42574946
Hyponatraemia 44.50 14.63 23 42654 101439 42477219
Paranoia 44.14 14.63 62 42615 13964 42564694
Application site scar 43.99 14.63 9 42668 16 42578642
Asthenia 43.78 14.63 140 42537 280653 42298005
Intentional misuse of drug delivery system 43.64 14.63 9 42668 17 42578641
Tremor neonatal 43.50 14.63 17 42660 481 42578177
Infusion related reaction 43.42 14.63 5 42672 60801 42517857
Neuropathy peripheral 43.34 14.63 24 42653 101829 42476829
Therapeutic product effect increased 42.26 14.63 19 42658 768 42577890
Application site discolouration 41.41 14.63 15 42662 342 42578316
Congenital multiplex arthrogryposis 41.38 14.63 14 42663 259 42578399
Application site exfoliation 41.26 14.63 13 42664 190 42578468
Injection site induration 40.19 14.63 31 42646 3456 42575202
Oral administration complication 39.97 14.63 10 42667 58 42578600
Intentional underdose 39.94 14.63 18 42659 732 42577926
Pleural effusion 39.76 14.63 24 42653 97142 42481516
Bradykinesia 39.37 14.63 37 42640 5399 42573259
Application site hypersensitivity 39.27 14.63 11 42666 104 42578554
Road traffic accident 38.71 14.63 69 42608 19024 42559634
Bradyphrenia 38.46 14.63 36 42641 5226 42573432
Cerebrovascular accident 38.38 14.63 25 42652 97135 42481523
Breech presentation 37.56 14.63 12 42665 184 42578474
Blood creatinine increased 37.44 14.63 33 42644 109970 42468688
Endocarditis staphylococcal 37.09 14.63 17 42660 719 42577939
Aspartate aminotransferase increased 36.11 14.63 16 42661 77147 42501511
Aptyalism 35.82 14.63 14 42663 396 42578262
Superior mesenteric artery syndrome 35.56 14.63 10 42667 96 42578562
Application site discharge 35.55 14.63 11 42666 151 42578507
Cardiac failure congestive 35.23 14.63 21 42656 85581 42493077
Housebound 35.22 14.63 12 42665 227 42578431
Endocarditis 34.98 14.63 42 42635 8110 42570548
Foetal distress syndrome 34.87 14.63 19 42658 1167 42577491
Intentional overdose 34.74 14.63 122 42555 51334 42527324
Pancytopenia 34.73 14.63 40 42637 117703 42460955
Product dispensing issue 34.46 14.63 12 42665 243 42578415
Low birth weight baby 34.33 14.63 46 42631 9909 42568749
Epistaxis 34.33 14.63 12 42665 66814 42511844
Application site erosion 33.93 14.63 10 42667 115 42578543
Decreased gait velocity 33.77 14.63 11 42666 180 42578478
Prescription form tampering 33.58 14.63 15 42662 597 42578061
Phlebotomy 33.47 14.63 9 42668 72 42578586
Delirium 33.31 14.63 122 42555 52397 42526261
Inappropriate schedule of product discontinuation 32.97 14.63 8 42669 40 42578618
Foetal exposure timing unspecified 32.87 14.63 12 42665 280 42578378
Abnormal behaviour 32.77 14.63 78 42599 26373 42552285
Skin irritation 32.46 14.63 39 42638 7535 42571123
Blood glucose increased 31.88 14.63 17 42660 73682 42504976
Product dose omission issue 31.65 14.63 67 42610 154298 42424360
Sarcopenia 31.30 14.63 16 42661 862 42577796
Mucosal inflammation 30.81 14.63 6 42671 49368 42529290
Diabetes mellitus 30.50 14.63 11 42666 60076 42518582
Pneumonia aspiration 29.82 14.63 114 42563 49964 42528694
Dehydration 29.51 14.63 61 42616 141706 42436952
Congestive hepatopathy 29.27 14.63 22 42655 2360 42576298
Hypertension 29.18 14.63 79 42598 167125 42411533
Joint swelling 28.97 14.63 16 42661 68006 42510652
Prostate cancer 28.77 14.63 5 42672 44638 42534020
Suicide attempt 28.32 14.63 106 42571 45994 42532664
Vestibular ischaemia 28.24 14.63 6 42671 14 42578644
Suicidal ideation 28.16 14.63 109 42568 48052 42530606
Glomerulonephritis acute 27.99 14.63 9 42668 141 42578517
Haemorrhage 27.65 14.63 13 42664 60550 42518108
Abdominal distension 27.59 14.63 19 42658 71716 42506942
Product packaging quantity issue 27.36 14.63 17 42660 1336 42577322
Renal failure 27.32 14.63 65 42612 143661 42434997
Traumatic coma 27.15 14.63 6 42671 18 42578640
Coronary artery disease 26.99 14.63 10 42667 53710 42524948
Injection site scab 26.97 14.63 7 42670 48 42578610
Sedation 26.69 14.63 79 42598 30396 42548262
Bladder dilatation 26.25 14.63 18 42659 1672 42576986
Infection 26.15 14.63 45 42632 112023 42466635
Ear deformity acquired 26.08 14.63 5 42672 5 42578653
Hallucination, visual 26.05 14.63 62 42615 20958 42557700
Sepsis 25.36 14.63 108 42569 199226 42379432
Hypertonia 25.21 14.63 28 42649 4973 42573685
Hyperkalaemia 25.19 14.63 26 42651 80432 42498226
Bronchitis 25.07 14.63 8 42669 47193 42531465
Myelosuppression 25.07 14.63 5 42672 40456 42538202
Application site scab 24.91 14.63 7 42670 67 42578591
Treatment failure 24.88 14.63 16 42661 62608 42516050
Therapeutic product effect decreased 24.87 14.63 91 42586 39059 42539599
Rash maculo-papular 24.61 14.63 4 42673 37499 42541159
Drug reaction with eosinophilia and systemic symptoms 24.45 14.63 6 42671 42069 42536589
Myocardial infarction 24.44 14.63 55 42622 123954 42454704
Accidental death 24.30 14.63 22 42655 3061 42575597
Lethargy 24.13 14.63 102 42575 46788 42531870
Product use in unapproved indication 24.05 14.63 99 42578 184357 42394301
Back pain 23.97 14.63 68 42609 141708 42436950
Injection site bruising 23.81 14.63 42 42635 11483 42567175
Behavioural addiction 23.79 14.63 7 42670 80 42578578
Embolia cutis medicamentosa 23.75 14.63 10 42667 344 42578314
Herpes zoster 23.68 14.63 5 42672 38872 42539786
Palmoplantar pustulosis 23.60 14.63 11 42666 484 42578174
Mydriasis 23.58 14.63 36 42641 8734 42569924
Gun shot wound 23.46 14.63 14 42663 1023 42577635
Drug tolerance 23.07 14.63 22 42655 3268 42575390
Gastrointestinal haemorrhage 23.02 14.63 39 42638 97687 42480971
Wrong dose 22.89 14.63 14 42663 1070 42577588
Upper respiratory tract infection 22.66 14.63 7 42670 42166 42536492
Confusional state 22.64 14.63 262 42415 167335 42411323
Abdominal pain 22.54 14.63 106 42571 190365 42388293
International normalised ratio increased 22.51 14.63 10 42667 48158 42530500
Loss of consciousness 22.50 14.63 164 42513 92190 42486468
Hypoventilation 22.18 14.63 23 42654 3779 42574879
Rhesus incompatibility 22.09 14.63 6 42671 50 42578608
Product use issue 22.08 14.63 142 42535 76609 42502049
Vestibular disorder 21.83 14.63 14 42663 1163 42577495
Feeding intolerance 21.70 14.63 9 42668 298 42578360
Agitation neonatal 21.69 14.63 15 42662 1413 42577245
Injection site mass 21.39 14.63 34 42643 8541 42570117
Restless legs syndrome 21.12 14.63 36 42641 9578 42569080
Delusion 21.08 14.63 46 42631 14688 42563970
Hypoxic-ischaemic encephalopathy 21.02 14.63 26 42651 5176 42573482
Joint hyperextension 20.97 14.63 7 42670 124 42578534
Mastication disorder 20.93 14.63 16 42661 1760 42576898
Application site haemorrhage 20.83 14.63 10 42667 470 42578188
Myocardial depression 20.82 14.63 7 42670 127 42578531
Hyperglycaemia 20.69 14.63 10 42667 45849 42532809
Chronic actinic dermatitis 20.60 14.63 5 42672 25 42578633
Neutrophil count decreased 20.42 14.63 20 42657 63395 42515263
Urinary tract infection 20.41 14.63 43 42634 99241 42479417
Drug level fluctuating 20.38 14.63 11 42666 663 42577995
Dementia with Lewy bodies 20.06 14.63 12 42665 881 42577777
Neonatal aspiration 20.05 14.63 6 42671 73 42578585
Clumsiness 19.98 14.63 16 42661 1884 42576774
Drug resistance 19.68 14.63 5 42672 34243 42544415
Urinary retention 19.56 14.63 89 42588 42125 42536533
Psychotic behaviour 19.33 14.63 12 42665 942 42577716
Eschar 19.29 14.63 11 42666 738 42577920
Renal impairment 19.28 14.63 52 42625 110176 42468482
Transient ischaemic attack 19.24 14.63 5 42672 33734 42544924
Decreased appetite 19.21 14.63 114 42563 193023 42385635
Alcohol withdrawal syndrome 19.17 14.63 14 42663 1437 42577221
Respiratory failure 19.15 14.63 65 42612 128067 42450591
Inflammatory pain 19.12 14.63 10 42667 565 42578093
Glabellar reflex abnormal 19.05 14.63 5 42672 36 42578622
Coordination abnormal 18.82 14.63 31 42646 8019 42570639
Social problem 18.81 14.63 13 42664 1223 42577435
Secondary hypogonadism 18.80 14.63 11 42666 775 42577883
Psychotic disorder 18.64 14.63 68 42609 29140 42549518
Therapy naive 18.48 14.63 5 42672 41 42578617
Dyspnoea exertional 18.35 14.63 14 42663 50134 42528524
Cyanosis 18.26 14.63 44 42633 14987 42563671
Incoherent 18.26 14.63 23 42654 4662 42573996
Micrognathia 18.21 14.63 8 42669 306 42578352
Cytokine release syndrome 18.20 14.63 11 42666 44516 42534142
Therapy non-responder 18.15 14.63 16 42661 53343 42525315
Ascites 18.10 14.63 18 42659 56660 42521998
Blood bilirubin increased 17.90 14.63 10 42667 42242 42536416
Disturbance in attention 17.78 14.63 68 42609 29798 42548860
Injection site ischaemia 17.72 14.63 3 42674 0 42578658
Application site odour 17.72 14.63 3 42674 0 42578658
Pain in extremity 17.70 14.63 84 42593 150520 42428138
Injection site discolouration 17.70 14.63 15 42662 1911 42576747
Laryngomalacia 17.64 14.63 8 42669 330 42578328
Respiratory rate decreased 17.51 14.63 18 42659 2927 42575731
Anorgasmia 17.40 14.63 12 42665 1125 42577533
Influenza 17.39 14.63 22 42655 62153 42516505
Pericardial effusion 17.35 14.63 4 42673 29271 42549387
Multiple cardiac defects 17.25 14.63 5 42672 54 42578604
Blood cholesterol increased 17.22 14.63 3 42674 26738 42551920
Application site ulcer 17.21 14.63 4 42673 16 42578642
Poverty 17.21 14.63 4 42673 16 42578642
Emotional poverty 17.12 14.63 10 42667 702 42577956
Panic reaction 16.99 14.63 14 42663 1716 42576942
Condition aggravated 16.98 14.63 173 42504 260581 42318077
Pulmonary congestion 16.96 14.63 44 42633 15686 42562972
Productive cough 16.90 14.63 16 42661 51551 42527107
Rectal haemorrhage 16.72 14.63 15 42662 49591 42529067
Neonatal respiratory distress 16.72 14.63 11 42666 954 42577704
Unresponsive to stimuli 16.69 14.63 69 42608 31334 42547324
Weight increased 16.67 14.63 54 42623 107929 42470729
Troponin T increased 16.55 14.63 17 42660 2763 42575895
Alcohol interaction 16.36 14.63 15 42662 2120 42576538
Arthritis 16.36 14.63 11 42666 42054 42536604
Pulmonary embolism 16.33 14.63 63 42614 119549 42459109
Gout 16.30 14.63 4 42673 28051 42550607
Product physical issue 16.28 14.63 18 42659 3181 42575477
Nasal septum deviation 16.14 14.63 12 42665 1266 42577392
Adrenergic syndrome 16.08 14.63 6 42671 149 42578509
Brief psychotic disorder with marked stressors 15.95 14.63 7 42670 267 42578391
Product substitution issue 15.87 14.63 35 42642 11255 42567403
Colitis 15.80 14.63 14 42663 46558 42532100
Cardiogenic shock 15.73 14.63 8 42669 35632 42543026
Anger 15.70 14.63 38 42639 12980 42565678
Dementia 15.66 14.63 44 42633 16436 42562222
Administration site abscess sterile 15.65 14.63 3 42674 3 42578655
Drug ineffective 15.34 14.63 498 42179 629699 41948959
C-reactive protein increased 15.30 14.63 25 42652 63535 42515123
Haematocrit decreased 15.17 14.63 8 42669 34900 42543758
Eosinophilia 15.11 14.63 7 42670 32892 42545766
Tachyphrenia 14.88 14.63 12 42665 1427 42577231
Photophobia 14.76 14.63 28 42649 8091 42570567
Selective eating disorder 14.72 14.63 13 42664 1751 42576907
Colitis ulcerative 14.70 14.63 4 42673 26171 42552487

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
Drug abuse 2248.46 12.63 1755 124356 175656 110287532
Drug withdrawal syndrome 1712.72 12.63 846 125265 37208 110425980
Drug dependence 1078.77 12.63 686 125425 49334 110413854
Application site pruritus 957.47 12.63 302 125809 3858 110459330
Product adhesion issue 843.25 12.63 254 125857 2752 110460436
Substance abuse 795.63 12.63 353 125758 12110 110451078
Drug use disorder 745.66 12.63 379 125732 17695 110445493
Blepharospasm 726.65 12.63 558 125553 54293 110408895
Miosis 700.48 12.63 388 125723 21595 110441593
Application site erythema 691.41 12.63 255 125856 5355 110457833
Taste disorder 557.51 12.63 516 125595 64871 110398317
Epilepsy 542.09 12.63 619 125492 99590 110363598
Breast cancer stage III 524.44 12.63 544 125567 78573 110384615
Application site rash 510.85 12.63 165 125946 2285 110460903
Intentional product misuse 494.94 12.63 681 125430 132223 110330965
Onychomadesis 494.84 12.63 413 125698 45250 110417938
Withdrawal syndrome 488.90 12.63 352 125759 31028 110432160
Toxicity to various agents 474.46 12.63 1411 124700 479144 109984044
Back injury 459.15 12.63 402 125709 46997 110416191
Nail disorder 443.91 12.63 431 125680 57504 110405684
Application site burn 405.66 12.63 113 125998 904 110462284
Inadequate analgesia 390.27 12.63 164 125947 4913 110458275
Application site vesicles 386.91 12.63 120 125991 1444 110461744
Application site pain 374.40 12.63 163 125948 5336 110457852
Facet joint syndrome 370.74 12.63 503 125608 96325 110366863
Product quality issue 359.28 12.63 442 125669 76857 110386331
Maternal exposure during pregnancy 346.52 12.63 843 125268 254040 110209148
Intentional product use issue 333.88 12.63 817 125294 247089 110216099
Bursitis 330.79 12.63 558 125553 129360 110333828
Onychomycosis 322.42 12.63 301 125810 38230 110424958
Substance use disorder 309.79 12.63 156 125955 7134 110456054
Hypercholesterolaemia 307.71 12.63 445 125666 90392 110372796
Wound infection 307.18 12.63 459 125652 96006 110367182
Overdose 301.61 12.63 758 125353 233036 110230152
Product label confusion 296.48 12.63 229 125882 22448 110440740
Gastrooesophageal reflux disease 295.01 12.63 641 125470 179335 110283853
Peripheral venous disease 289.19 12.63 415 125696 83702 110379486
Pyrexia 283.39 12.63 366 125745 897899 109565289
Finger deformity 279.75 12.63 260 125851 32832 110430356
Respiratory depression 277.44 12.63 255 125856 31746 110431442
Adverse reaction 266.70 12.63 241 125870 29353 110433835
Live birth 265.99 12.63 361 125750 69123 110394065
Alcohol abuse 262.22 12.63 123 125988 4806 110458382
Coeliac disease 243.99 12.63 273 125838 42914 110420274
Febrile neutropenia 240.34 12.63 37 126074 316730 110146458
Lip dry 231.36 12.63 412 125699 99671 110363517
Type 2 diabetes mellitus 229.91 12.63 576 125535 176656 110286532
Obesity 217.67 12.63 431 125680 112920 110350268
Psoriatic arthropathy 216.09 12.63 601 125510 196160 110267028
Folliculitis 214.45 12.63 542 125569 167111 110296077
Coma 210.65 12.63 435 125676 117434 110345754
Cough 209.70 12.63 134 125977 461507 110001681
Neutropenia 199.05 12.63 89 126022 374531 110088657
Grip strength decreased 196.92 12.63 339 125772 79835 110383353
Asphyxia 195.59 12.63 148 125963 14067 110449121
Anaemia 190.31 12.63 206 125905 546880 109916308
Accidental overdose 187.38 12.63 262 125849 51572 110411616
Duodenal ulcer perforation 185.53 12.63 533 125578 177167 110286021
Infusion site reaction 181.36 12.63 155 125956 17527 110445661
Confusional state 181.18 12.63 1030 125081 467650 109995538
Memory impairment 178.53 12.63 562 125549 196382 110266806
Fibromyalgia 176.85 12.63 511 125600 170398 110292790
Neck pain 176.53 12.63 416 125695 122714 110340474
Liver function test increased 176.42 12.63 342 125769 88206 110374982
Helicobacter infection 173.19 12.63 528 125583 181349 110281839
Joint range of motion decreased 171.83 12.63 409 125702 121423 110341765
Muscle injury 169.50 12.63 445 125666 140362 110322826
Application site scar 168.75 12.63 40 126071 151 110463037
C-reactive protein increased 165.66 12.63 586 125525 217333 110245855
Application site irritation 163.84 12.63 67 126044 1870 110461318
Anti-cyclic citrullinated peptide antibody positive 161.90 12.63 516 125595 181468 110281720
Injection site reaction 160.63 12.63 330 125781 88740 110374448
Migraine 159.41 12.63 494 125617 171158 110292030
Thrombocytopenia 158.74 12.63 101 126010 348784 110114404
Inflammation 158.53 12.63 533 125578 192705 110270483
Pemphigus 157.13 12.63 570 125541 214000 110249188
Gait inability 157.07 12.63 424 125687 135952 110327236
Night sweats 156.77 12.63 419 125692 133564 110329624
Platelet count decreased 155.43 12.63 36 126075 230407 110232781
Liver injury 154.90 12.63 449 125662 149964 110313224
Drug screen negative 153.14 12.63 42 126069 315 110462873
Dry mouth 153.11 12.63 539 125572 199409 110263779
White blood cell count decreased 152.42 12.63 37 126074 229353 110233835
Disease progression 151.51 12.63 45 126066 243989 110219199
Glossodynia 148.63 12.63 573 125538 221431 110241757
Acute kidney injury 146.20 12.63 317 125794 635113 109828075
Drug screen positive 145.81 12.63 91 126020 6319 110456869
Exposure during pregnancy 144.64 12.63 470 125641 166954 110296234
Blood cholesterol increased 143.96 12.63 501 125610 184284 110278904
Haemoglobin decreased 141.95 12.63 53 126058 248674 110214514
Rheumatic fever 141.05 12.63 381 125730 122198 110340990
Aggression 141.00 12.63 247 125864 58963 110404225
Drug detoxification 140.77 12.63 44 126067 544 110462644
Somnolence 138.95 12.63 689 125422 296760 110166428
Drug delivery system removal 138.66 12.63 24 126087 0 110463188
Injection site ulcer 138.66 12.63 48 126063 832 110462356
Osteoarthritis 136.98 12.63 489 125622 182134 110281054
Wound 134.62 12.63 577 125534 233860 110229328
Pericarditis 134.17 12.63 550 125561 218564 110244624
COVID-19 133.63 12.63 56 126055 245004 110218184
Product dose omission issue 130.84 12.63 105 126006 321677 110141511
Application site dryness 129.72 12.63 35 126076 245 110462943
Irritable bowel syndrome 129.44 12.63 447 125664 163768 110299420
Drug-induced liver injury 127.08 12.63 362 125749 119705 110343483
Hand deformity 124.84 12.63 537 125574 217969 110245219
Impaired healing 123.78 12.63 498 125613 196219 110266969
Injection site abscess 122.19 12.63 55 126056 1951 110461237
Blister 120.21 12.63 546 125565 226830 110236358
Accidental exposure to product by child 120.17 12.63 63 126048 3135 110460053
Diarrhoea 119.86 12.63 785 125326 1138720 109324468
Abdominal pain upper 119.82 12.63 744 125367 348367 110114821
Systemic lupus erythematosus 118.65 12.63 589 125522 253749 110209439
Infection 117.59 12.63 144 125967 362056 110101132
Bradypnoea 116.68 12.63 89 126022 8560 110454628
Lung disorder 116.64 12.63 460 125651 179587 110283601
Interstitial lung disease 113.43 12.63 13 126098 139321 110323867
Hepatitis 110.79 12.63 287 125824 89767 110373421
Sleep disorder 110.26 12.63 484 125627 198160 110265028
Application site discharge 109.41 12.63 33 126078 359 110462829
Hypoaesthesia 108.02 12.63 670 125441 313553 110149635
Hypotension 107.13 12.63 278 125833 523571 109939617
Pancytopenia 106.34 12.63 53 126058 209560 110253628
Injection site infection 105.83 12.63 54 126057 2539 110460649
Application site discolouration 105.11 12.63 41 126070 1008 110462180
Accidental poisoning 105.02 12.63 53 126058 2434 110460754
Paraesthesia 104.23 12.63 604 125507 275917 110187271
Musculoskeletal pain 103.91 12.63 449 125662 182574 110280614
Urinary tract infection 102.48 12.63 133 125978 326149 110137039
Application site exfoliation 101.20 12.63 34 126077 536 110462652
Application site urticaria 100.95 12.63 28 126083 220 110462968
Sinusitis 97.29 12.63 117 125994 296571 110166617
Substance dependence 96.93 12.63 35 126076 690 110462498
Death 96.73 12.63 1219 124892 697650 109765538
Fatigue 95.11 12.63 908 125203 1215050 109248138
Influenza 94.85 12.63 37 126074 169064 110294124
Aspartate aminotransferase increased 94.78 12.63 32 126079 159904 110303284
Dyspnoea 93.28 12.63 811 125300 1106061 109357127
Weight decreased 92.94 12.63 252 125859 467805 109995383
Agitation 92.81 12.63 312 125799 112739 110350449
Erythema 90.29 12.63 120 125991 291327 110171861
Depression 89.39 12.63 644 125467 316691 110146497
Hyperaesthesia 88.18 12.63 96 126015 14631 110448557
Injection site necrosis 87.60 12.63 42 126069 1724 110461464
Rheumatoid arthritis 86.69 12.63 612 125499 299001 110164187
Euphoric mood 85.71 12.63 75 126036 8752 110454436
Neuropathy peripheral 85.54 12.63 49 126062 179228 110283960
Atrial fibrillation 83.63 12.63 83 126028 229559 110233629
Application site erosion 83.14 12.63 26 126085 322 110462866
Sepsis 83.13 12.63 154 125957 327192 110135996
Blood creatinine increased 83.05 12.63 53 126058 182836 110280352
Herpes zoster 81.36 12.63 13 126098 108366 110354822
Cerebrovascular accident 80.33 12.63 54 126057 181230 110281958
Malignant neoplasm progression 80.08 12.63 50 126061 174517 110288671
Synovitis 79.95 12.63 561 125550 273531 110189657
Myelosuppression 78.83 12.63 8 126103 94332 110368856
Pleural effusion 78.66 12.63 53 126058 177656 110285532
Overlap syndrome 78.14 12.63 72 126039 8987 110454201
Injection site erosion 75.60 12.63 21 126090 166 110463022
Lower respiratory tract infection 75.29 12.63 505 125606 242601 110220587
Contraindicated product administered 74.67 12.63 512 125599 247755 110215433
Hepatic enzyme 73.79 12.63 55 126056 5108 110458080
Brain oedema 73.08 12.63 129 125982 30969 110432219
Myocardial infarction 71.59 12.63 68 126043 192015 110271173
Hyponatraemia 70.10 12.63 87 126024 217566 110245622
Cardiac failure congestive 69.60 12.63 43 126068 150957 110312231
Blood glucose increased 69.48 12.63 32 126079 132464 110330724
Ill-defined disorder 69.41 12.63 358 125753 156495 110306693
Pruritus 69.13 12.63 385 125726 581175 109882013
Mucosal inflammation 68.95 12.63 13 126098 96128 110367060
Substance use 68.42 12.63 40 126071 2466 110460722
Poisoning 67.45 12.63 120 125991 28985 110434203
Injury 67.27 12.63 388 125723 176877 110286311
Gastrointestinal haemorrhage 67.24 12.63 54 126057 165464 110297724
Logorrhoea 66.85 12.63 51 126060 4906 110458282
General physical health deterioration 66.68 12.63 760 125351 424535 110038653
Dehydration 66.19 12.63 137 125974 279374 110183814
Diabetes mellitus 66.04 12.63 16 126095 99365 110363823
Incorrect product administration duration 65.86 12.63 98 126013 20400 110442788
Neutrophil count decreased 65.32 12.63 28 126083 120913 110342275
Hypocholesterolaemia 65.26 12.63 56 126055 6365 110456823
Therapeutic product effect decreased 64.88 12.63 489 125622 243827 110219361
Wrong technique in product usage process 63.83 12.63 232 125879 87116 110376072
Normal newborn 63.74 12.63 100 126011 21796 110441392
Wheezing 62.87 12.63 502 125609 254728 110208460
Productive cough 62.48 12.63 26 126085 114279 110348909
Thrombosis 62.22 12.63 23 126088 108639 110354549
Chest discomfort 61.96 12.63 64 126047 173784 110289404
Renal failure 61.67 12.63 102 126009 226472 110236716
Arthritis 61.67 12.63 60 126051 167526 110295662
C-reactive protein abnormal 61.59 12.63 302 125809 129393 110333795
Nasal congestion 61.19 12.63 18 126093 98264 110364924
Pulmonary embolism 60.78 12.63 94 126017 214380 110248808
Back pain 60.69 12.63 218 125893 370778 110092410
Colitis 59.71 12.63 21 126090 102302 110360886
Lactic acidosis 59.64 12.63 16 126095 92795 110370393
Dyspnoea exertional 59.63 12.63 22 126089 104038 110359150
Yawning 59.62 12.63 31 126080 1516 110461672
Arthropathy 59.50 12.63 544 125567 286978 110176210
Application site swelling 59.43 12.63 26 126085 861 110462327
Hyperkalaemia 59.42 12.63 41 126070 135755 110327433
Drug reaction with eosinophilia and systemic symptoms 59.09 12.63 11 126100 82084 110381104
Product administered at inappropriate site 58.85 12.63 49 126062 5344 110457844
Bronchitis 58.04 12.63 56 126055 156976 110306212
Leukopenia 57.43 12.63 51 126060 148740 110314448
Application site reaction 57.31 12.63 25 126086 822 110462366
Hepatitis C 56.94 12.63 71 126040 12502 110450686
Stomatitis 56.26 12.63 512 125599 269730 110193458
Muscle spasms 55.90 12.63 523 125588 277634 110185554
Respiratory failure 55.80 12.63 100 126011 215232 110247956
Oropharyngeal pain 55.11 12.63 44 126067 135232 110327956
Drug withdrawal syndrome neonatal 55.06 12.63 19 126092 326 110462862
Endocarditis staphylococcal 54.53 12.63 26 126085 1054 110462134
Injection site cellulitis 54.51 12.63 32 126079 1988 110461200
Brachial artery entrapment syndrome 54.45 12.63 13 126098 51 110463137
Drug diversion 54.18 12.63 28 126083 1352 110461836
Application site scab 54.18 12.63 17 126094 213 110462975
Haemorrhage 54.06 12.63 27 126084 106665 110356523
Mobility decreased 53.65 12.63 458 125653 236964 110226224
Dyspepsia 53.41 12.63 387 125724 190578 110272610
Rash maculo-papular 53.30 12.63 10 126101 74212 110388976
Pneumonia 53.16 12.63 693 125418 876021 109587167
Epistaxis 52.37 12.63 43 126068 130329 110332859
Coronary artery disease 50.76 12.63 10 126101 71680 110391508
Cataract 50.51 12.63 14 126097 79471 110383717
Muscular weakness 50.33 12.63 468 125643 248000 110215188
Application site ulcer 50.25 12.63 14 126097 112 110463076
Cytomegalovirus infection 50.01 12.63 3 126108 54441 110408747
Chest pain 49.84 12.63 240 125871 376135 110087053
Haematocrit decreased 49.47 12.63 8 126103 66109 110397079
Intentional removal of drug delivery system by patient 49.41 12.63 9 126102 3 110463185
Blood pressure increased 49.08 12.63 142 125969 258231 110204957
Chills 48.05 12.63 90 126021 190490 110272698
Impaired driving ability 48.03 12.63 47 126064 6323 110456865
Clostridium difficile infection 47.50 12.63 3 126108 52126 110411062
Blood pressure decreased 47.43 12.63 37 126074 115054 110348134
Drug ineffective 47.15 12.63 1348 124763 1519192 108943996
Alanine aminotransferase increased 47.03 12.63 86 126025 183687 110279501
Product solubility abnormal 46.85 12.63 24 126087 1138 110462050
Neurodegenerative disorder 46.11 12.63 21 126090 766 110462422
Application site dermatitis 45.25 12.63 14 126097 167 110463021
Hallucination 44.50 12.63 231 125880 101201 110361987
Throat irritation 43.57 12.63 5 126106 53547 110409641
Cytokine release syndrome 43.54 12.63 13 126098 70293 110392895
Product physical issue 43.39 12.63 40 126071 4996 110458192
Cluster headache 43.15 12.63 23 126088 1184 110462004
Anaphylactic reaction 43.12 12.63 40 126071 114260 110348928
Haematochezia 42.91 12.63 41 126070 115483 110347705
Upper respiratory tract infection 42.79 12.63 52 126059 131276 110331912
Hepatic enzyme increased 42.66 12.63 556 125555 320336 110142852
Abdominal distension 42.33 12.63 343 125768 174760 110288428
Expulsion of medication 42.08 12.63 11 126100 67 110463121
Blood potassium decreased 41.74 12.63 6 126105 54108 110409080
Injection site discharge 41.71 12.63 24 126087 1436 110461752
Underdose 41.62 12.63 163 125948 63391 110399797
Altered state of consciousness 41.21 12.63 152 125959 57474 110405714
Diverticulitis 41.13 12.63 6 126105 53516 110409672
Off label use 40.84 12.63 1353 124758 1498832 108964356
Hypokalaemia 40.22 12.63 93 126018 182355 110280833
Depressed level of consciousness 40.15 12.63 242 125869 112036 110351152
Basal cell carcinoma 40.10 12.63 3 126108 45267 110417921
Application site odour 40.07 12.63 9 126102 25 110463163
Renal impairment 40.00 12.63 98 126013 188347 110274841
Flushing 39.10 12.63 37 126074 104699 110358489
Cardiac disorder 39.10 12.63 19 126092 76261 110386927
Myalgia 38.83 12.63 127 125984 222254 110240934
Drug intolerance 38.68 12.63 665 125446 405847 110057341
Application site haemorrhage 38.54 12.63 23 126088 1473 110461715
Pericardial effusion 38.43 12.63 9 126102 57208 110405980
Intentional underdose 38.30 12.63 28 126083 2524 110460664
Abdominal pain 38.25 12.63 387 125724 512602 109950586
Stress 37.28 12.63 39 126072 105309 110357879
Drug abuser 37.26 12.63 38 126073 5371 110457817
Colitis ulcerative 37.10 12.63 21 126090 77342 110385846
Product use issue 36.51 12.63 528 125583 311167 110152021
Skin exfoliation 36.34 12.63 28 126083 87623 110375565
Deep vein thrombosis 36.20 12.63 65 126046 139822 110323366
Red blood cell count decreased 36.01 12.63 15 126096 65908 110397280
Paranoia 35.81 12.63 79 126032 22295 110440893
Drug resistance 35.69 12.63 10 126101 56364 110406824
Defaecation disorder 35.66 12.63 18 126093 827 110462361
Poisoning deliberate 35.59 12.63 87 126024 26244 110436944
Visceral congestion 35.49 12.63 21 126090 1324 110461864
Rash erythematous 35.41 12.63 25 126086 81807 110381381
Angioedema 35.38 12.63 36 126075 98464 110364724
Eosinophilia 35.36 12.63 11 126100 57925 110405263
Subchondral insufficiency fracture 35.13 12.63 9 126102 50 110463138
Breakthrough pain 34.91 12.63 22 126089 1554 110461634
Neurosis 34.87 12.63 16 126095 594 110462594
Haemoptysis 34.75 12.63 19 126092 71335 110391853
17 ketosteroids urine abnormal 34.67 12.63 6 126105 0 110463188
Cystitis 34.54 12.63 16 126095 66020 110397168
Proteinuria 34.48 12.63 3 126108 40015 110423173
Restlessness 34.21 12.63 141 125970 56118 110407070
Hypomagnesaemia 34.19 12.63 13 126098 60357 110402831
Quadriparesis 34.13 12.63 34 126077 4673 110458515
Skin irritation 33.67 12.63 64 126047 16255 110446933
Cardiac failure 33.56 12.63 106 126005 187520 110275668
Multiple sclerosis relapse 33.55 12.63 8 126103 50232 110412956
Septic shock 33.37 12.63 82 126029 157446 110305742
Impaired reasoning 33.30 12.63 10 126101 107 110463081
Therapeutic product effect increased 33.09 12.63 22 126089 1703 110461485
Respiratory arrest 33.03 12.63 143 125968 58156 110405032
Lymphocyte count decreased 32.96 12.63 12 126099 57231 110405957
Disease recurrence 32.93 12.63 14 126097 60770 110402418
Compartment syndrome 32.75 12.63 37 126074 5873 110457315
Transient ischaemic attack 32.70 12.63 16 126095 63966 110399222
Lymphadenopathy 32.57 12.63 16 126095 63819 110399369
Congenital coronary artery malformation 32.49 12.63 10 126101 117 110463071
Application site inflammation 32.45 12.63 14 126097 448 110462740
Fungal infection 32.19 12.63 9 126102 50797 110412391
Acute myocardial infarction 31.98 12.63 29 126082 83748 110379440
Full blood count abnormal 31.86 12.63 12 126099 56040 110407148
Blood bilirubin increased 31.84 12.63 24 126087 75948 110387240
Bradycardia foetal 31.82 12.63 10 126101 126 110463062
Dry skin 31.63 12.63 46 126065 107607 110355581
Rectal haemorrhage 31.62 12.63 55 126056 119778 110343410
Pulmonary mass 31.59 12.63 3 126108 37298 110425890
Breast cancer stage II 31.37 12.63 85 126026 27290 110435898
Cellulitis 31.33 12.63 60 126051 125956 110337232
Phlebotomy 31.17 12.63 9 126102 83 110463105
Asthma 31.17 12.63 163 125948 250128 110213060
Decreased gait velocity 30.99 12.63 11 126100 206 110462982
Viral infection 30.84 12.63 11 126100 53128 110410060
Product dispensing issue 30.77 12.63 15 126096 639 110462549
Congenital multiplex arthrogryposis 30.76 12.63 7 126104 21 110463167
Bronchiectasis 30.73 12.63 3 126108 36490 110426698
Hepatotoxicity 30.70 12.63 17 126094 63383 110399805
Palmar-plantar erythrodysaesthesia syndrome 30.61 12.63 5 126106 41020 110422168
Injection site pain 30.60 12.63 324 125787 177598 110285590
Hepatocellular injury 30.22 12.63 10 126101 50632 110412556
Therapy non-responder 30.19 12.63 86 126025 157221 110305967
Blood pressure systolic increased 30.19 12.63 30 126081 82961 110380227
Pneumocystis jirovecii pneumonia 30.17 12.63 6 126105 42729 110420459
Hyperlipidaemia 30.05 12.63 3 126108 35845 110427343
Dry eye 29.99 12.63 13 126098 55780 110407408
Ascites 29.97 12.63 37 126074 92771 110370417
International normalised ratio increased 29.73 12.63 33 126078 86739 110376449
Disorientation 29.66 12.63 159 125952 70512 110392676
Drug eruption 29.65 12.63 12 126099 53647 110409541
Dysphagia 29.46 12.63 84 126027 153516 110309672
Prostate cancer 29.44 12.63 4 126107 37637 110425551
Rhinorrhoea 29.07 12.63 45 126066 102621 110360567
Body temperature increased 29.01 12.63 13 126098 54700 110408488
Alopecia 28.89 12.63 580 125531 364173 110099015
Plasma cell myeloma 28.89 12.63 18 126093 62918 110400270
Ventricular fibrillation 28.75 12.63 6 126105 41307 110421881
Application site pustules 28.64 12.63 7 126104 31 110463157
Dermo-hypodermitis 28.60 12.63 19 126092 1469 110461719
Therapeutic product effect incomplete 28.57 12.63 385 125726 223420 110239768
Hyperglycaemia 28.46 12.63 33 126078 85057 110378131
Multiple organ dysfunction syndrome 28.35 12.63 84 126027 151626 110311562
Incorrect route of product administration 28.17 12.63 146 125965 63915 110399273
Hypothyroidism 28.11 12.63 25 126086 72874 110390314
Syncope 28.05 12.63 127 125984 202409 110260779
Urticaria 27.97 12.63 515 125596 318342 110144846
Posterior reversible encephalopathy syndrome 27.95 12.63 3 126108 33858 110429330
Abnormal behaviour 27.93 12.63 103 126008 38936 110424252
Transaminases increased 27.91 12.63 19 126092 63371 110399817
Abdominal discomfort 27.85 12.63 616 125495 393242 110069946
Blood alkaline phosphatase increased 27.74 12.63 24 126087 70911 110392277
Anaphylactic shock 27.72 12.63 12 126099 51534 110411654
Persecutory delusion 27.65 12.63 35 126076 6256 110456932
Nephrolithiasis 27.64 12.63 21 126090 66191 110396997
Vasculitis 27.61 12.63 4 126107 35869 110427319
Vestibular ischaemia 27.46 12.63 6 126105 14 110463174
Psoriasis 27.26 12.63 76 126035 139917 110323271
Superior mesenteric artery syndrome 26.97 12.63 10 126101 213 110462975
Cardiogenic shock 26.87 12.63 16 126095 57322 110405866
Disseminated intravascular coagulation 26.75 12.63 7 126104 41279 110421909
Haematoma 26.46 12.63 17 126094 58459 110404729
Injection site extravasation 26.28 12.63 44 126067 10125 110453063
Hypoxia 26.21 12.63 69 126042 129446 110333742
Delirium 26.16 12.63 252 125859 134773 110328415
Full blood count decreased 26.10 12.63 3 126108 32096 110431092
Myelopathy 26.07 12.63 32 126079 5544 110457644
Heart rate increased 25.90 12.63 81 126030 143753 110319435
Dysgeusia 25.80 12.63 25 126086 69960 110393228
Ear deformity acquired 25.43 12.63 5 126106 5 110463183
Agranulocytosis 25.26 12.63 20 126091 61740 110401448
Face oedema 25.15 12.63 4 126107 33465 110429723
Gastritis 25.14 12.63 15 126096 53684 110409504
Fluid retention 25.14 12.63 43 126068 94264 110368924
Swelling 25.12 12.63 550 125561 350491 110112697
Myelodysplastic syndrome 24.97 12.63 6 126105 37478 110425710
Respiratory tract congestion 24.81 12.63 3 126108 30854 110432334
Abdominal pain lower 24.77 12.63 6 126105 37277 110425911
Therapy interrupted 24.65 12.63 13 126098 49809 110413379
Sarcopenia 24.54 12.63 16 126095 1198 110461990
Sinus disorder 24.39 12.63 4 126107 32724 110430464
Bacterial infection 24.31 12.63 11 126100 46025 110417163
Acute respiratory failure 24.30 12.63 30 126081 75230 110387958
Liver disorder 24.30 12.63 82 126029 142161 110321027
Tubulointerstitial nephritis 24.26 12.63 16 126095 54268 110408920
Illness 24.25 12.63 35 126076 82136 110381052
Persistent depressive disorder 23.99 12.63 17 126094 1460 110461728
Subdural haematoma 23.96 12.63 6 126105 36448 110426740
Lymphopenia 23.85 12.63 8 126103 40162 110423026
Visual acuity reduced 23.83 12.63 4 126107 32169 110431019
Aptyalism 23.78 12.63 14 126097 874 110462314
Heart rate decreased 23.69 12.63 36 126075 82720 110380468
Acute myeloid leukaemia 23.68 12.63 7 126104 38103 110425085
Pulmonary oedema 23.68 12.63 196 125915 100463 110362725
Hanging 23.67 12.63 9 126102 206 110462982
Hypercalcaemia 23.34 12.63 12 126099 46645 110416543
Bone marrow failure 23.33 12.63 19 126092 57829 110405359
White blood cell count increased 23.30 12.63 47 126064 96795 110366393
Ulcer 23.25 12.63 10 126101 43106 110420082
Haemophagocytic lymphohistiocytosis 23.21 12.63 4 126107 31555 110431633
Bone pain 23.17 12.63 24 126087 65109 110398079
Sleep disorder due to general medical condition, insomnia type 23.16 12.63 54 126057 105589 110357599
Pain in jaw 22.99 12.63 15 126096 51162 110412026
Bradyphrenia 22.98 12.63 45 126066 11683 110451505
Housebound 22.93 12.63 11 126100 452 110462736
Mental status changes 22.88 12.63 32 126079 76090 110387098
COVID-19 pneumonia 22.76 12.63 7 126104 37136 110426052
Neoplasm progression 22.76 12.63 24 126087 64571 110398617
Hypophosphataemia 22.72 12.63 5 126106 33177 110430011
Hip fracture 22.69 12.63 6 126105 35145 110428043
Application site hypersensitivity 22.67 12.63 10 126101 338 110462850
Hepatic function abnormal 22.65 12.63 42 126069 89253 110373935
Hepatic failure 22.62 12.63 27 126084 68712 110394476
Diabetic ketoacidosis 22.29 12.63 10 126101 42048 110421140
Central pain syndrome 22.15 12.63 13 126098 807 110462381
Product physical consistency issue 22.07 12.63 16 126095 1424 110461764
Headache 21.78 12.63 805 125306 881572 109581616
Cytopenia 21.75 12.63 4 126107 30112 110433076
Rash pruritic 21.60 12.63 50 126061 98019 110365169
Device related infection 21.57 12.63 9 126102 39510 110423678
Micrognathia 21.50 12.63 5 126106 17 110463171
Intentional misuse of drug delivery system 21.50 12.63 5 126106 17 110463171
Bronchopulmonary aspergillosis 21.49 12.63 4 126107 29859 110433329
Nephropathy toxic 21.30 12.63 3 126108 27475 110435713
Bradycardia 21.24 12.63 98 126013 155419 110307769
Insomnia 21.24 12.63 550 125561 360040 110103148
Disturbance in attention 21.13 12.63 132 125979 61863 110401325
Shock 21.12 12.63 18 126093 53570 110409618
Infusion related reaction 20.91 12.63 576 125535 380586 110082602
Application site induration 20.88 12.63 4 126107 3 110463185
Clostridium difficile colitis 20.82 12.63 12 126099 43766 110419422
Injection site ischaemia 20.67 12.63 5 126106 21 110463167
Chronic actinic dermatitis 20.67 12.63 5 126106 21 110463167
Bradykinesia 20.66 12.63 41 126070 10747 110452441
Eye disorder 20.53 12.63 4 126107 28902 110434286
Hypophagia 20.34 12.63 18 126093 52608 110410580
Candida infection 20.33 12.63 15 126096 47994 110415194
Bladder dilatation 20.29 12.63 19 126092 2420 110460768
Hyperbilirubinaemia 20.25 12.63 5 126106 30666 110432522
Gait disturbance 20.24 12.63 211 125900 277997 110185191
Hyperhidrosis 20.24 12.63 313 125798 186985 110276203
Glomerulonephritis acute 20.19 12.63 9 126102 312 110462876
Eczema 20.17 12.63 32 126079 72261 110390927
Obstructive airways disorder 20.09 12.63 14 126097 46135 110417053
Stress cardiomyopathy 20.07 12.63 51 126060 15755 110447433
Toxic epidermal necrolysis 20.07 12.63 21 126090 56706 110406482
Endocarditis 20.05 12.63 46 126065 13325 110449863
Hypertonia 19.92 12.63 35 126076 8371 110454817
Tendonitis 19.87 12.63 3 126108 26080 110437108
Cholelithiasis 19.73 12.63 26 126085 63396 110399792
Respiratory tract infection 19.70 12.63 32 126079 71585 110391603
Hemiparesis 19.54 12.63 13 126098 43890 110419298
Pancreatitis acute 19.49 12.63 24 126087 60250 110402938
Pneumonitis 19.40 12.63 36 126075 76495 110386693
Aspergillus infection 19.39 12.63 3 126108 25613 110437575
Rash 19.36 12.63 753 125358 820211 109642977
Acne 19.35 12.63 7 126104 33513 110429675
Vulvar basal cell carcinoma 19.19 12.63 5 126106 30 110463158
Drug ineffective for unapproved indication 19.16 12.63 57 126054 102781 110360407
Ulcer haemorrhage 19.14 12.63 63 126048 22508 110440680
Accidental death 19.12 12.63 26 126085 4983 110458205
Renal disorder 19.04 12.63 17 126094 49462 110413726
Hypervolaemia 19.02 12.63 17 126094 49443 110413745
Application site papules 18.99 12.63 6 126105 77 110463111
Blood sodium decreased 18.96 12.63 10 126101 38309 110424879
Oral candidiasis 18.94 12.63 14 126097 44746 110418442
Tachyphrenia 18.93 12.63 18 126093 2338 110460850
Traumatic coma 18.92 12.63 6 126105 78 110463110
Pulmonary hypertension 18.92 12.63 21 126090 55199 110407989
Psychomotor skills impaired 18.85 12.63 31 126080 7027 110456161
Echocardiogram abnormal 18.81 12.63 19 126092 2655 110460533
Eyelid retraction 18.71 12.63 6 126105 81 110463107
Amaurosis fugax 18.71 12.63 18 126093 2372 110460816
Device issue 18.64 12.63 8 126103 34527 110428661
Victim of sexual abuse 18.51 12.63 10 126101 529 110462659
Ileus 18.46 12.63 6 126105 30723 110432465
Vision blurred 18.41 12.63 80 126031 128942 110334246
Oedema peripheral 18.33 12.63 264 125847 328396 110134792
Glabellar reflex abnormal 18.29 12.63 5 126106 37 110463151
Bacteraemia 18.27 12.63 13 126098 42377 110420811
Poor venous access 18.27 12.63 3 126108 24519 110438669
Splenomegaly 18.25 12.63 3 126108 24495 110438693
Dislocation of vertebra 18.10 12.63 98 126013 43623 110419565
Palpitations 18.00 12.63 107 126004 159105 110304083
Gastroenteritis 17.94 12.63 11 126100 38789 110424399
Cerebral haemorrhage 17.89 12.63 29 126082 64939 110398249
Chemical submission 17.82 12.63 10 126101 570 110462618
Psychotic behaviour 17.78 12.63 14 126097 1411 110461777
Hypoacusis 17.68 12.63 9 126102 35182 110428006
Blood triglycerides increased 17.66 12.63 3 126108 23923 110439265
Eye irritation 17.66 12.63 8 126103 33444 110429744
Suicidal ideation 17.55 12.63 174 125937 93763 110369425
Mitral valve incompetence 17.54 12.63 8 126103 33321 110429867
Blood pressure fluctuation 17.42 12.63 37 126074 74787 110388401
Oesophageal motility disorder 17.39 12.63 11 126100 782 110462406
Surgery 17.35 12.63 13 126098 41270 110421918
Foetal non-stress test abnormal 17.33 12.63 3 126108 0 110463188
Hiatus hernia 17.28 12.63 5 126106 27601 110435587
Prescription drug used without a prescription 17.26 12.63 26 126085 5470 110457718
Breath sounds abnormal 17.05 12.63 4 126107 25400 110437788
Stevens-Johnson syndrome 17.00 12.63 17 126094 46884 110416304
Pyelonephritis 16.90 12.63 4 126107 25246 110437942
Product packaging quantity issue 16.89 12.63 15 126096 1784 110461404
Pulmonary arterial hypertension 16.86 12.63 8 126103 32560 110430628
Hypoalbuminaemia 16.81 12.63 6 126105 28968 110434220
Haemorrhage intracranial 16.80 12.63 6 126105 28963 110434225
Blood calcium decreased 16.80 12.63 10 126101 35835 110427353
Staphylococcal infection 16.78 12.63 34 126077 69910 110393278
Chronic sinusitis 16.74 12.63 4 126107 25080 110438108
Osteonecrosis of jaw 16.74 12.63 18 126093 47999 110415189
Dementia with Lewy bodies 16.69 12.63 12 126099 1054 110462134
Maternal use of illicit drugs 16.69 12.63 4 126107 16 110463172
Immunodeficiency 16.62 12.63 12 126099 38826 110424362
Blood urea increased 16.62 12.63 23 126088 54934 110408254
Flatulence 16.62 12.63 21 126090 52128 110411060
Drug interaction 16.59 12.63 713 125398 499470 109963718
Secondary hypogonadism 16.54 12.63 11 126100 852 110462336
Therapy partial responder 16.46 12.63 11 126100 37050 110426138
Skin discolouration 16.42 12.63 19 126092 49027 110414161
Blood test abnormal 16.42 12.63 6 126105 28548 110434640
Decreased appetite 16.41 12.63 415 125696 475431 109987757
Sinus arrhythmia 16.34 12.63 16 126095 2154 110461034
Appendicitis 16.33 12.63 6 126105 28458 110434730
Gastrointestinal disorder 16.33 12.63 376 125735 241576 110221612
Atelectasis 16.17 12.63 11 126100 36701 110426487
Impaired work ability 16.15 12.63 5 126106 26414 110436774
Device dislocation 16.09 12.63 8 126103 31696 110431492
Application site perspiration 15.97 12.63 4 126107 20 110463168
Oedema 15.79 12.63 158 125953 209818 110253370
Oral administration complication 15.71 12.63 6 126105 139 110463049
Right ventricular failure 15.71 12.63 5 126106 25949 110437239
Rheumatoid factor positive 15.67 12.63 87 126024 131553 110331635
Drug tolerance 15.62 12.63 48 126063 16537 110446651
Toxic skin eruption 15.45 12.63 6 126105 27509 110435679
Nodule 15.44 12.63 9 126102 32622 110430566
Hyperthyroidism 15.44 12.63 7 126104 29254 110433934
Cerebral infarction 15.37 12.63 22 126089 51816 110411372
Eating disorder 15.34 12.63 8 126103 30850 110432338
Therapy naive 15.30 12.63 5 126106 72 110463116
Administration site abscess sterile 15.26 12.63 3 126108 3 110463185
Palmoplantar pustulosis 15.21 12.63 11 126100 975 110462213
Angina pectoris 15.18 12.63 30 126081 62265 110400923
Conversion disorder 15.16 12.63 16 126095 2354 110460834
Breast cancer 15.12 12.63 13 126098 38529 110424659
Inappropriate antidiuretic hormone secretion 15.10 12.63 10 126101 33841 110429347
Hot flush 15.09 12.63 33 126078 66003 110397185
Musculoskeletal chest pain 15.07 12.63 7 126104 28840 110434348
Metastases to liver 15.06 12.63 11 126100 35375 110427813
Blood lactate dehydrogenase increased 15.03 12.63 17 126094 44317 110418871
Pharyngitis 14.90 12.63 5 126106 25093 110438095
Bronchospasm 14.80 12.63 8 126103 30231 110432957
Myopathy 14.77 12.63 5 126106 24955 110438233
Deafness 14.71 12.63 6 126105 26703 110436485
Poverty 14.70 12.63 4 126107 29 110463159
Emotional poverty 14.69 12.63 11 126100 1029 110462159
Myocarditis 14.64 12.63 8 126103 30047 110433141
Coagulopathy 14.64 12.63 15 126096 40896 110422292
Injection site oedema 14.58 12.63 14 126097 1840 110461348
Lung infiltration 14.46 12.63 5 126106 24623 110438565
Social problem 14.45 12.63 14 126097 1860 110461328
Troponin increased 14.38 12.63 8 126103 29758 110433430
Musculoskeletal disorder 14.38 12.63 4 126107 22660 110440528
Visual impairment 14.34 12.63 92 126019 134336 110328852
Subarachnoid haemorrhage 14.33 12.63 8 126103 29694 110433494
Deafness neurosensory 14.32 12.63 33 126078 9586 110453602
Skin fissures 14.30 12.63 5 126106 24453 110438735
Application site infection 14.27 12.63 5 126106 90 110463098
Gastroenteritis viral 14.23 12.63 9 126102 31217 110431971
Immune thrombocytopenia 14.22 12.63 4 126107 22490 110440698
Hepatic steatosis 14.21 12.63 21 126090 48810 110414378
Blood glucose decreased 14.14 12.63 8 126103 29480 110433708
Ventricular tachycardia 14.08 12.63 22 126089 49987 110413201
Human bite 14.04 12.63 3 126108 6 110463182
Application site wound 14.04 12.63 3 126108 6 110463182
Gun shot wound 14.03 12.63 11 126100 1101 110462087
Application site bruise 14.02 12.63 7 126104 314 110462874
Foot deformity 13.96 12.63 21 126090 48459 110414729
Leukocytosis 13.93 12.63 25 126086 53803 110409385
Victim of crime 13.93 12.63 12 126099 1371 110461817
Inappropriate schedule of product discontinuation 13.92 12.63 5 126106 97 110463091
Radial nerve palsy 13.91 12.63 8 126103 478 110462710
Dysarthria 13.90 12.63 152 125959 83969 110379219
Dizziness 13.90 12.63 949 125162 697244 109765944
Lymphoma 13.89 12.63 3 126108 20168 110443020
Hypocalcaemia 13.86 12.63 34 126077 65332 110397856
Mydriasis 13.84 12.63 56 126055 22101 110441087
Alcohol interaction 13.84 12.63 19 126092 3675 110459513
Complication associated with device 13.80 12.63 3 126108 20070 110443118
Application site hypoaesthesia 13.73 12.63 3 126108 7 110463181
Small intestinal obstruction 13.73 12.63 10 126101 32203 110430985
Chronic kidney disease 13.71 12.63 43 126068 76248 110386940
Chronic obstructive pulmonary disease 13.63 12.63 71 126040 109087 110354101
Sneezing 13.54 12.63 10 126101 31974 110431214
Ejection fraction decreased 13.51 12.63 16 126095 40864 110422324
Neurotoxicity 13.44 12.63 17 126094 42190 110420998
Musculoskeletal discomfort 13.44 12.63 5 126106 23533 110439655
Gastric disorder 13.39 12.63 11 126100 33346 110429842
Lupus vulgaris 13.39 12.63 75 126036 33808 110429380
Cholestasis 13.33 12.63 34 126077 64484 110398704
Dependence 13.31 12.63 16 126095 2713 110460475
Brief psychotic disorder with marked stressors 13.26 12.63 7 126104 353 110462835
Impaired quality of life 13.21 12.63 9 126102 30008 110433180
Embolia cutis medicamentosa 13.19 12.63 10 126101 953 110462235
Cystic lymphangioma 13.18 12.63 3 126108 9 110463179
Feeling drunk 13.16 12.63 23 126088 5477 110457711
Progressive multifocal leukoencephalopathy 13.12 12.63 6 126105 24950 110438238
Aphasia 13.05 12.63 30 126081 58967 110404221
Treatment failure 13.02 12.63 411 125700 276823 110186365
Bone disorder 12.97 12.63 4 126107 21188 110442000
Mastication disorder 12.95 12.63 18 126093 3520 110459668
Eye pruritus 12.92 12.63 11 126100 32764 110430424
Living alone 12.83 12.63 4 126107 49 110463139
Unresponsive to stimuli 12.82 12.63 120 125991 63670 110399518
Injection site inflammation 12.81 12.63 21 126090 4750 110458438
Mouth ulceration 12.78 12.63 22 126089 48116 110415072
Pneumonia bacterial 12.77 12.63 7 126104 26254 110436934
Metastases to central nervous system 12.77 12.63 5 126106 22812 110440376
Hemiplegia 12.74 12.63 5 126106 22777 110440411
Congestive hepatopathy 12.71 12.63 22 126089 5198 110457990
Placental disorder 12.67 12.63 10 126101 1011 110462177

FDA Adverse Event Reporting System (Pediatric)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Drug withdrawal syndrome neonatal 83.95 37.39 60 250 2370 111273

Pharmacologic Action:

SourceCodeDescription
ATC N02AE01 NERVOUS SYSTEM
ANALGESICS
OPIOIDS
Oripavine derivatives
ATC N07BC01 NERVOUS SYSTEM
OTHER NERVOUS SYSTEM DRUGS
DRUGS USED IN ADDICTIVE DISORDERS
Drugs used in opioid dependence
ATC N07BC51 NERVOUS SYSTEM
OTHER NERVOUS SYSTEM DRUGS
DRUGS USED IN ADDICTIVE DISORDERS
Drugs used in opioid dependence
CHEBI has role CHEBI:35482 opioid analgesic
CHEBI has role CHEBI:55322 μ-opioid receptor agonist
CHEBI has role CHEBI:59283 δ-opioid receptor antagonist
CHEBI has role CHEBI:167165 κ-opioid receptor antagonist
MeSH PA D000700 Analgesics
MeSH PA D000701 Analgesics, Opioid
MeSH PA D002492 Central Nervous System Depressants
MeSH PA D009292 Narcotic Antagonists
MeSH PA D009294 Narcotics
MeSH PA D018689 Sensory System Agents
FDA MoA N0000175685 Partial Opioid Agonists
FDA EPC N0000175689 Partial Opioid Agonist
CHEBI has role CHEBI:59282 κ-opioid receptor agonist

Related Drugs by ATC class:

N07BC Drugs used in opioid dependence 5 drugs
diamorphinelevomethadonelevomethadyl acetatelofexidinemethadone

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

DiseaseRelationSNOMED_IDDOID
Opioid dependence indication 75544000 DOID:2559
Severe pain indication 76948002
Chronic pain indication 82423001
Prevention of opioid abuse indication 426928008
Acute postoperative pain indication 107401000119105
Chronic Pain with Opioid Tolerance indication
Opioid withdrawal off-label use 87132004
Dependent drug abuse contraindication 6525002
Alcohol withdrawal delirium contraindication 8635005
Chronic obstructive lung disease contraindication 13645005 DOID:3083
Asthenia contraindication 13791008
Chronic disease of respiratory system contraindication 17097001
Alcohol intoxication contraindication 25702006
Orthostatic hypotension contraindication 28651003
Hypercapnia contraindication 29596007
Torsades de pointes contraindication 31722008
Hypothyroidism contraindication 40930008 DOID:1459
Paralytic ileus contraindication 55525008 DOID:8442
Chronic type B viral hepatitis contraindication 61977001
Benign intracranial hypertension contraindication 68267002 DOID:11459
Urethral stricture contraindication 76618002
Decreased respiratory function contraindication 80954004
Injury of head contraindication 82271004
Cor pulmonale contraindication 83291003 DOID:8515
Disorder of biliary tract contraindication 105997008 DOID:9741
Prolonged QT interval contraindication 111975006
Chronic hepatitis C contraindication 128302006
Liver function tests abnormal contraindication 166603001
Drug-induced psychosis contraindication 191483003 DOID:1742
Disease of liver contraindication 235856003 DOID:409
Benign prostatic hyperplasia contraindication 266569009
Lesion of brain contraindication 301766008
Adrenal cortical hypofunction contraindication 386584007 DOID:10493
Hypoxia contraindication 389086002
Respiratory insufficiency contraindication 409623005
Central nervous system depression contraindication 418072004
Congenital long QT syndrome contraindication 442917000
Kyphoscoliosis with Respiratory Compromise contraindication
Pain in Opioid Naive Patients contraindication




🐶 Veterinary Drug Use

SpeciesUseRelation
Cats Postoperative pain associated with surgical procedures Indication

🐶 Veterinary products

ProductApplicantIngredients
Simbadol Zoetis Inc. 1
Zorbium Elanco US Inc. 1

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 9.97 acidic
pKa2 8.88 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
128MG/0.36ML (356MG/ML) BRIXADI BRAEBURN N210136 May 23, 2023 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS 8236755 July 31, 2026 A METHOD OF DELIVERY OF AN OPIOID BIOACTIVE AGENT. A METHOD OF TREATMENT OR PROPHYLAXIS OF A HUMAN OR NON-HUMAN ANIMAL FOR THE TREATMENT OF OPIOID ADDICTION AND/OR THE SYMPTOMS OF OPIOID WITHDRAWAL
16MG/0.32ML (50MG/ML) BRIXADI BRAEBURN N210136 May 23, 2023 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS 8236755 July 31, 2026 A METHOD OF DELIVERY OF AN OPIOID BIOACTIVE AGENT. A METHOD OF TREATMENT OR PROPHYLAXIS OF A HUMAN OR NON-HUMAN ANIMAL FOR THE TREATMENT OF OPIOID ADDICTION AND/OR THE SYMPTOMS OF OPIOID WITHDRAWAL
24MG/0.48ML (50MG/ML) BRIXADI BRAEBURN N210136 May 23, 2023 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS 8236755 July 31, 2026 A METHOD OF DELIVERY OF AN OPIOID BIOACTIVE AGENT. A METHOD OF TREATMENT OR PROPHYLAXIS OF A HUMAN OR NON-HUMAN ANIMAL FOR THE TREATMENT OF OPIOID ADDICTION AND/OR THE SYMPTOMS OF OPIOID WITHDRAWAL
32MG/0.64ML (50MG/ML) BRIXADI BRAEBURN N210136 May 23, 2023 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS 8236755 July 31, 2026 A METHOD OF DELIVERY OF AN OPIOID BIOACTIVE AGENT. A METHOD OF TREATMENT OR PROPHYLAXIS OF A HUMAN OR NON-HUMAN ANIMAL FOR THE TREATMENT OF OPIOID ADDICTION AND/OR THE SYMPTOMS OF OPIOID WITHDRAWAL
64MG/0.18ML (356MG/ML) BRIXADI BRAEBURN N210136 May 23, 2023 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS 8236755 July 31, 2026 A METHOD OF DELIVERY OF AN OPIOID BIOACTIVE AGENT. A METHOD OF TREATMENT OR PROPHYLAXIS OF A HUMAN OR NON-HUMAN ANIMAL FOR THE TREATMENT OF OPIOID ADDICTION AND/OR THE SYMPTOMS OF OPIOID WITHDRAWAL
8MG/0.16ML (50MG/ML) BRIXADI BRAEBURN N210136 May 23, 2023 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS 8236755 July 31, 2026 A METHOD OF DELIVERY OF AN OPIOID BIOACTIVE AGENT. A METHOD OF TREATMENT OR PROPHYLAXIS OF A HUMAN OR NON-HUMAN ANIMAL FOR THE TREATMENT OF OPIOID ADDICTION AND/OR THE SYMPTOMS OF OPIOID WITHDRAWAL
96MG/0.27ML (356MG/ML) BRIXADI BRAEBURN N210136 May 23, 2023 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS 8236755 July 31, 2026 A METHOD OF DELIVERY OF AN OPIOID BIOACTIVE AGENT. A METHOD OF TREATMENT OR PROPHYLAXIS OF A HUMAN OR NON-HUMAN ANIMAL FOR THE TREATMENT OF OPIOID ADDICTION AND/OR THE SYMPTOMS OF OPIOID WITHDRAWAL
128MG/0.36ML (356MG/ML) BRIXADI BRAEBURN N210136 May 23, 2023 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS 8236292 Jan. 10, 2027 A METHOD OF DELIVERY OF A BIOACTIVE AGENT BY SUBCUTANEOUS INJECTION. A METHOD OF TREATMENT OF A HUMAN FOR ADDICTION
16MG/0.32ML (50MG/ML) BRIXADI BRAEBURN N210136 May 23, 2023 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS 8236292 Jan. 10, 2027 A METHOD OF DELIVERY OF A BIOACTIVE AGENT BY SUBCUTANEOUS INJECTION. A METHOD OF TREATMENT OF A HUMAN FOR ADDICTION
24MG/0.48ML (50MG/ML) BRIXADI BRAEBURN N210136 May 23, 2023 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS 8236292 Jan. 10, 2027 A METHOD OF DELIVERY OF A BIOACTIVE AGENT BY SUBCUTANEOUS INJECTION. A METHOD OF TREATMENT OF A HUMAN FOR ADDICTION
32MG/0.64ML (50MG/ML) BRIXADI BRAEBURN N210136 May 23, 2023 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS 8236292 Jan. 10, 2027 A METHOD OF DELIVERY OF A BIOACTIVE AGENT BY SUBCUTANEOUS INJECTION. A METHOD OF TREATMENT OF A HUMAN FOR ADDICTION
64MG/0.18ML (356MG/ML) BRIXADI BRAEBURN N210136 May 23, 2023 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS 8236292 Jan. 10, 2027 A METHOD OF DELIVERY OF A BIOACTIVE AGENT BY SUBCUTANEOUS INJECTION. A METHOD OF TREATMENT OF A HUMAN FOR ADDICTION
8MG/0.16ML (50MG/ML) BRIXADI BRAEBURN N210136 May 23, 2023 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS 8236292 Jan. 10, 2027 A METHOD OF DELIVERY OF A BIOACTIVE AGENT BY SUBCUTANEOUS INJECTION. A METHOD OF TREATMENT OF A HUMAN FOR ADDICTION
96MG/0.27ML (356MG/ML) BRIXADI BRAEBURN N210136 May 23, 2023 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS 8236292 Jan. 10, 2027 A METHOD OF DELIVERY OF A BIOACTIVE AGENT BY SUBCUTANEOUS INJECTION. A METHOD OF TREATMENT OF A HUMAN FOR ADDICTION
EQ 2.1MG BASE;EQ 0.3MG BASE BUNAVAIL BDSI N205637 June 6, 2014 DISCN FILM BUCCAL 8147866 July 23, 2027 MAINTENANCE TREATMENT OF OPIOID DEPENDENCE
EQ 2.1MG BASE;EQ 0.3MG BASE BUNAVAIL BDSI N205637 June 6, 2014 DISCN FILM BUCCAL 9655843 July 23, 2027 TREATMENT OF OPIOID DEPENDENCE
EQ 4.2MG BASE;EQ 0.7MG BASE BUNAVAIL BDSI N205637 June 6, 2014 DISCN FILM BUCCAL 8147866 July 23, 2027 MAINTENANCE TREATMENT OF OPIOID DEPENDENCE
EQ 4.2MG BASE;EQ 0.7MG BASE BUNAVAIL BDSI N205637 June 6, 2014 DISCN FILM BUCCAL 9655843 July 23, 2027 TREATMENT OF OPIOID DEPENDENCE
EQ 6.3MG BASE;EQ 1MG BASE BUNAVAIL BDSI N205637 June 6, 2014 DISCN FILM BUCCAL 8147866 July 23, 2027 MAINTENANCE TREATMENT OF OPIOID DEPENDENCE
EQ 6.3MG BASE;EQ 1MG BASE BUNAVAIL BDSI N205637 June 6, 2014 DISCN FILM BUCCAL 9655843 July 23, 2027 TREATMENT OF OPIOID DEPENDENCE
EQ 0.075MG BASE BELBUCA BDSI N207932 Oct. 23, 2015 RX FILM BUCCAL 8147866 July 23, 2027 TREATMENT OF PAIN BY TRANSMUCOSAL DELIVERY OF BUPRENORPHINE
EQ 0.075MG BASE BELBUCA BDSI N207932 Oct. 23, 2015 RX FILM BUCCAL 9655843 July 23, 2027 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
EQ 0.15MG BASE BELBUCA BDSI N207932 Oct. 23, 2015 RX FILM BUCCAL 8147866 July 23, 2027 TREATMENT OF PAIN BY TRANSMUCOSAL DELIVERY OF BUPRENORPHINE
EQ 0.15MG BASE BELBUCA BDSI N207932 Oct. 23, 2015 RX FILM BUCCAL 9655843 July 23, 2027 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
EQ 0.3MG BASE BELBUCA BDSI N207932 Oct. 23, 2015 RX FILM BUCCAL 8147866 July 23, 2027 TREATMENT OF PAIN BY TRANSMUCOSAL DELIVERY OF BUPRENORPHINE
EQ 0.3MG BASE BELBUCA BDSI N207932 Oct. 23, 2015 RX FILM BUCCAL 9655843 July 23, 2027 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
EQ 0.45MG BASE BELBUCA BDSI N207932 Oct. 23, 2015 RX FILM BUCCAL 8147866 July 23, 2027 TREATMENT OF PAIN BY TRANSMUCOSAL DELIVERY OF BUPRENORPHINE
EQ 0.45MG BASE BELBUCA BDSI N207932 Oct. 23, 2015 RX FILM BUCCAL 9655843 July 23, 2027 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
EQ 0.6MG BASE BELBUCA BDSI N207932 Oct. 23, 2015 RX FILM BUCCAL 8147866 July 23, 2027 TREATMENT OF PAIN BY TRANSMUCOSAL DELIVERY OF BUPRENORPHINE
EQ 0.6MG BASE BELBUCA BDSI N207932 Oct. 23, 2015 RX FILM BUCCAL 9655843 July 23, 2027 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
EQ 0.75MG BASE BELBUCA BDSI N207932 Oct. 23, 2015 RX FILM BUCCAL 8147866 July 23, 2027 TREATMENT OF PAIN BY TRANSMUCOSAL DELIVERY OF BUPRENORPHINE
EQ 0.75MG BASE BELBUCA BDSI N207932 Oct. 23, 2015 RX FILM BUCCAL 9655843 July 23, 2027 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
EQ 0.9MG BASE BELBUCA BDSI N207932 Oct. 23, 2015 RX FILM BUCCAL 8147866 July 23, 2027 TREATMENT OF PAIN BY TRANSMUCOSAL DELIVERY OF BUPRENORPHINE
EQ 0.9MG BASE BELBUCA BDSI N207932 Oct. 23, 2015 RX FILM BUCCAL 9655843 July 23, 2027 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
EQ 0.7MG BASE;EQ 0.18MG BASE ZUBSOLV EDENBRIDGE PHARMS N204242 Oct. 4, 2016 RX TABLET SUBLINGUAL 8658198 Dec. 3, 2027 SUBLINGUAL OR BUCCAL ADMINISTRATION OF A PHARMACEUTICAL COMPOSITION COMPRISING BUPRENORPHINE AND NALOXONE
EQ 1.4MG BASE;EQ 0.36MG BASE ZUBSOLV EDENBRIDGE PHARMS N204242 July 3, 2013 RX TABLET SUBLINGUAL 8658198 Dec. 3, 2027 SUBLINGUAL OR BUCCAL ADMINISTRATION OF A PHARMACEUTICAL COMPOSITION COMPRISING BUPRENORPHINE AND NALOXONE
EQ 11.4MG BASE;EQ 2.9MG BASE ZUBSOLV EDENBRIDGE PHARMS N204242 Dec. 11, 2014 RX TABLET SUBLINGUAL 8658198 Dec. 3, 2027 SUBLINGUAL OR BUCCAL ADMINISTRATION OF A PHARMACEUTICAL COMPOSITION COMPRISING BUPRENORPHINE AND NALOXONE
EQ 2.9MG BASE;EQ 0.71MG BASE ZUBSOLV EDENBRIDGE PHARMS N204242 June 4, 2015 RX TABLET SUBLINGUAL 8658198 Dec. 3, 2027 SUBLINGUAL OR BUCCAL ADMINISTRATION OF A PHARMACEUTICAL COMPOSITION COMPRISING BUPRENORPHINE AND NALOXONE
EQ 5.7MG BASE;EQ 1.4MG BASE ZUBSOLV EDENBRIDGE PHARMS N204242 July 3, 2013 RX TABLET SUBLINGUAL 8658198 Dec. 3, 2027 SUBLINGUAL OR BUCCAL ADMINISTRATION OF A PHARMACEUTICAL COMPOSITION COMPRISING BUPRENORPHINE AND NALOXONE
EQ 8.6MG BASE;EQ 2.1MG BASE ZUBSOLV EDENBRIDGE PHARMS N204242 Dec. 11, 2014 RX TABLET SUBLINGUAL 8658198 Dec. 3, 2027 SUBLINGUAL OR BUCCAL ADMINISTRATION OF A PHARMACEUTICAL COMPOSITION COMPRISING BUPRENORPHINE AND NALOXONE
EQ 12MG BASE;EQ 3MG BASE SUBOXONE INDIVIOR N022410 Aug. 10, 2012 RX FILM BUCCAL, SUBLINGUAL 11135216 Aug. 7, 2029 TREATING OPIOID USE DISORDER
EQ 12MG BASE;EQ 3MG BASE SUBOXONE INDIVIOR N022410 Aug. 10, 2012 RX FILM BUCCAL, SUBLINGUAL 9687454 Aug. 7, 2029 TREATMENT OF OPIOID DEPENDENCE/SUBLINGUAL OR BUCCAL APPLICATION
EQ 2MG BASE;EQ 0.5MG BASE SUBOXONE INDIVIOR N022410 Aug. 30, 2010 RX FILM BUCCAL, SUBLINGUAL 11135216 Aug. 7, 2029 TREATING OPIOID USE DISORDER
EQ 2MG BASE;EQ 0.5MG BASE SUBOXONE INDIVIOR N022410 Aug. 30, 2010 RX FILM BUCCAL, SUBLINGUAL 9687454 Aug. 7, 2029 TREATMENT OF OPIOID DEPENDENCE/SUBLINGUAL OR BUCCAL APPLICATION
EQ 4MG BASE;EQ 1MG BASE SUBOXONE INDIVIOR N022410 Aug. 10, 2012 RX FILM BUCCAL, SUBLINGUAL 11135216 Aug. 7, 2029 TREATING OPIOID USE DISORDER
EQ 4MG BASE;EQ 1MG BASE SUBOXONE INDIVIOR N022410 Aug. 10, 2012 RX FILM BUCCAL, SUBLINGUAL 9687454 Aug. 7, 2029 TREATMENT OF OPIOID DEPENDENCE/SUBLINGUAL OR BUCCAL APPLICATION
EQ 8MG BASE;EQ 2MG BASE SUBOXONE INDIVIOR N022410 Aug. 30, 2010 RX FILM BUCCAL, SUBLINGUAL 11135216 Aug. 7, 2029 TREATING OPIOID USE DISORDER
EQ 8MG BASE;EQ 2MG BASE SUBOXONE INDIVIOR N022410 Aug. 30, 2010 RX FILM BUCCAL, SUBLINGUAL 9687454 Aug. 7, 2029 TREATMENT OF OPIOID DEPENDENCE/SUBLINGUAL OR BUCCAL APPLICATION
EQ 12MG BASE;EQ 3MG BASE SUBOXONE INDIVIOR N022410 Aug. 10, 2012 RX FILM BUCCAL, SUBLINGUAL 8475832 March 26, 2030 THIS DRUG IS ADMINISTERED BY SUBLINGUAL ROUTE TO HUMANS FOR MAINTENANCE TREATMENT OF OPIOID DEPENDENCE
EQ 2MG BASE;EQ 0.5MG BASE SUBOXONE INDIVIOR N022410 Aug. 30, 2010 RX FILM BUCCAL, SUBLINGUAL 8475832 March 26, 2030 THIS DRUG IS ADMINISTERED BY SUBLINGUAL ROUTE TO HUMANS FOR MAINTENANCE TREATMENT OF OPIOID DEPENDENCE
EQ 4MG BASE;EQ 1MG BASE SUBOXONE INDIVIOR N022410 Aug. 10, 2012 RX FILM BUCCAL, SUBLINGUAL 8475832 March 26, 2030 THIS DRUG IS ADMINISTERED BY SUBLINGUAL ROUTE TO HUMANS FOR MAINTENANCE TREATMENT OF OPIOID DEPENDENCE
EQ 8MG BASE;EQ 2MG BASE SUBOXONE INDIVIOR N022410 Aug. 30, 2010 RX FILM BUCCAL, SUBLINGUAL 8475832 March 26, 2030 THIS DRUG IS ADMINISTERED BY SUBLINGUAL ROUTE TO HUMANS FOR MAINTENANCE TREATMENT OF OPIOID DEPENDENCE
EQ 0.7MG BASE;EQ 0.18MG BASE ZUBSOLV EDENBRIDGE PHARMS N204242 Oct. 4, 2016 RX TABLET SUBLINGUAL 8470361 May 22, 2030 SUBLINGUAL ADMINISTRATION OF A PHARMACEUTICAL COMPOSITION COMPRISING BUPRENORPHINE AND NALOXONE
EQ 1.4MG BASE;EQ 0.36MG BASE ZUBSOLV EDENBRIDGE PHARMS N204242 July 3, 2013 RX TABLET SUBLINGUAL 8470361 May 22, 2030 SUBLINGUAL ADMINISTRATION OF A PHARMACEUTICAL COMPOSITION COMPRISING BUPRENORPHINE AND NALOXONE
EQ 11.4MG BASE;EQ 2.9MG BASE ZUBSOLV EDENBRIDGE PHARMS N204242 Dec. 11, 2014 RX TABLET SUBLINGUAL 8470361 May 22, 2030 SUBLINGUAL ADMINISTRATION OF A PHARMACEUTICAL COMPOSITION COMPRISING BUPRENORPHINE AND NALOXONE
EQ 2.9MG BASE;EQ 0.71MG BASE ZUBSOLV EDENBRIDGE PHARMS N204242 June 4, 2015 RX TABLET SUBLINGUAL 8470361 May 22, 2030 SUBLINGUAL ADMINISTRATION OF A PHARMACEUTICAL COMPOSITION COMPRISING BUPRENORPHINE AND NALOXONE
EQ 5.7MG BASE;EQ 1.4MG BASE ZUBSOLV EDENBRIDGE PHARMS N204242 July 3, 2013 RX TABLET SUBLINGUAL 8470361 May 22, 2030 SUBLINGUAL ADMINISTRATION OF A PHARMACEUTICAL COMPOSITION COMPRISING BUPRENORPHINE AND NALOXONE
EQ 8.6MG BASE;EQ 2.1MG BASE ZUBSOLV EDENBRIDGE PHARMS N204242 Dec. 11, 2014 RX TABLET SUBLINGUAL 8470361 May 22, 2030 SUBLINGUAL ADMINISTRATION OF A PHARMACEUTICAL COMPOSITION COMPRISING BUPRENORPHINE AND NALOXONE
100MG/0.5ML (100MG/0.5ML) SUBLOCADE INDIVIOR N209819 Nov. 30, 2017 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS 10198218 June 6, 2031 TREATMENT OF MODERATE TO SEVERE OPIOID USE DISORDER
100MG/0.5ML (100MG/0.5ML) SUBLOCADE INDIVIOR N209819 Nov. 30, 2017 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS 10592168 June 6, 2031 TREATMENT OF MODERATE TO SEVERE OPIOID USE DISORDER
100MG/0.5ML (100MG/0.5ML) SUBLOCADE INDIVIOR N209819 Nov. 30, 2017 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS 9272044 June 6, 2031 TREATING OPIOID ADDICTION BY ADMINISTERING BUPRENORPHINE
100MG/0.5ML (100MG/0.5ML) SUBLOCADE INDIVIOR N209819 Nov. 30, 2017 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS 9272044 June 6, 2031 TREATING OPIOID ADDICTION BY ADMINISTERING BUPRENORPHINE COMPOSITION WITH 28 DAY DOSE DURATION
100MG/0.5ML (100MG/0.5ML) SUBLOCADE INDIVIOR N209819 Nov. 30, 2017 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS 9272044 June 6, 2031 TREATING OPIOID ADDICTION BY ADMINISTERING BUPRENORPHINE ONCE PER MONTH
100MG/0.5ML (100MG/0.5ML) SUBLOCADE INDIVIOR N209819 Nov. 30, 2017 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS 9272044 June 6, 2031 TREATING OPIOID ADDICTION BY SUBCUTANEOUS INJECTION OF BUPRENORPHINE
100MG/0.5ML (100MG/0.5ML) SUBLOCADE INDIVIOR N209819 Nov. 30, 2017 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS 9498432 June 6, 2031 IN SITU FORMATION OF SOLID BUPRENORPHINE COMPOSITION
100MG/0.5ML (100MG/0.5ML) SUBLOCADE INDIVIOR N209819 Nov. 30, 2017 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS 9782402 June 6, 2031 TREATING ADDICTION BY ONCE PER MONTH ADMINISTRATION OF BUPRENORPHINE
100MG/0.5ML (100MG/0.5ML) SUBLOCADE INDIVIOR N209819 Nov. 30, 2017 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS 9782402 June 6, 2031 TREATING ADDICTION BY SUBCUTANEOUS INJECTION OF BUPRENORPHINE
100MG/0.5ML (100MG/0.5ML) SUBLOCADE INDIVIOR N209819 Nov. 30, 2017 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS 9782402 June 6, 2031 TREATING ADDICTION WITH 100 MG OR 300 MG DOSE OF BUPRENORPHINE
100MG/0.5ML (100MG/0.5ML) SUBLOCADE INDIVIOR N209819 Nov. 30, 2017 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS 9782402 June 6, 2031 TREATING OPIOID ADDICTION BY ADMINISTERING BUPRENORPHINE
100MG/0.5ML (100MG/0.5ML) SUBLOCADE INDIVIOR N209819 Nov. 30, 2017 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS 9827241 June 6, 2031 TREATING OPIOID ADDICTION BY 100 MG OR 300 MG DOSE BUPRENORPHINE
100MG/0.5ML (100MG/0.5ML) SUBLOCADE INDIVIOR N209819 Nov. 30, 2017 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS 9827241 June 6, 2031 TREATING OPIOID ADDICTION BY ADMINISTRATION OF BUPRENORPHINE
100MG/0.5ML (100MG/0.5ML) SUBLOCADE INDIVIOR N209819 Nov. 30, 2017 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS 9827241 June 6, 2031 TREATING OPIOID DEPENDENCY BY ADMINISTERING BUPRENORPHINE
100MG/0.5ML (100MG/0.5ML) SUBLOCADE INDIVIOR N209819 Nov. 30, 2017 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS 9827241 June 6, 2031 TREATING OPIOID DEPENDENCY BY ADMINISTERING BUPRENORPHINE ONCE PER MONTH
100MG/0.5ML (100MG/0.5ML) SUBLOCADE INDIVIOR N209819 Nov. 30, 2017 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS 9827241 June 6, 2031 TREATING OPIOID DEPENDENCY BY SUBCUTANEOUSLY ADMINISTERING BUPRENORPHINE
300MG/1.5ML (200MG/ML) SUBLOCADE INDIVIOR N209819 Nov. 30, 2017 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS 10198218 June 6, 2031 TREATMENT OF MODERATE TO SEVERE OPIOID USE DISORDER
300MG/1.5ML (200MG/ML) SUBLOCADE INDIVIOR N209819 Nov. 30, 2017 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS 10592168 June 6, 2031 TREATMENT OF MODERATE TO SEVERE OPIOID USE DISORDER
300MG/1.5ML (200MG/ML) SUBLOCADE INDIVIOR N209819 Nov. 30, 2017 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS 9272044 June 6, 2031 TREATING OPIOID ADDICTION BY ADMINISTERING BUPRENORPHINE
300MG/1.5ML (200MG/ML) SUBLOCADE INDIVIOR N209819 Nov. 30, 2017 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS 9272044 June 6, 2031 TREATING OPIOID ADDICTION BY ADMINISTERING BUPRENORPHINE COMPOSITION WITH 28 DAY DOSE DURATION
300MG/1.5ML (200MG/ML) SUBLOCADE INDIVIOR N209819 Nov. 30, 2017 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS 9272044 June 6, 2031 TREATING OPIOID ADDICTION BY ADMINISTERING BUPRENORPHINE ONCE PER MONTH
300MG/1.5ML (200MG/ML) SUBLOCADE INDIVIOR N209819 Nov. 30, 2017 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS 9272044 June 6, 2031 TREATING OPIOID ADDICTION BY SUBCUTANEOUS INJECTION OF BUPRENORPHINE
300MG/1.5ML (200MG/ML) SUBLOCADE INDIVIOR N209819 Nov. 30, 2017 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS 9498432 June 6, 2031 IN SITU FORMATION OF SOLID BUPRENORPHINE COMPOSITION
300MG/1.5ML (200MG/ML) SUBLOCADE INDIVIOR N209819 Nov. 30, 2017 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS 9782402 June 6, 2031 TREATING ADDICTION BY ONCE PER MONTH ADMINISTRATION OF BUPRENORPHINE
300MG/1.5ML (200MG/ML) SUBLOCADE INDIVIOR N209819 Nov. 30, 2017 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS 9782402 June 6, 2031 TREATING ADDICTION BY SUBCUTANEOUS INJECTION OF BUPRENORPHINE
300MG/1.5ML (200MG/ML) SUBLOCADE INDIVIOR N209819 Nov. 30, 2017 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS 9782402 June 6, 2031 TREATING ADDICTION WITH 100 MG OR 300 MG DOSE OF BUPRENORPHINE
300MG/1.5ML (200MG/ML) SUBLOCADE INDIVIOR N209819 Nov. 30, 2017 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS 9782402 June 6, 2031 TREATING OPIOID ADDICTION BY ADMINISTERING BUPRENORPHINE
300MG/1.5ML (200MG/ML) SUBLOCADE INDIVIOR N209819 Nov. 30, 2017 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS 9827241 June 6, 2031 TREATING OPIOID ADDICTION BY 100 MG OR 300 MG DOSE BUPRENORPHINE
300MG/1.5ML (200MG/ML) SUBLOCADE INDIVIOR N209819 Nov. 30, 2017 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS 9827241 June 6, 2031 TREATING OPIOID ADDICTION BY ADMINISTRATION OF BUPRENORPHINE
300MG/1.5ML (200MG/ML) SUBLOCADE INDIVIOR N209819 Nov. 30, 2017 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS 9827241 June 6, 2031 TREATING OPIOID DEPENDENCY BY ADMINISTERING BUPRENORPHINE
300MG/1.5ML (200MG/ML) SUBLOCADE INDIVIOR N209819 Nov. 30, 2017 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS 9827241 June 6, 2031 TREATING OPIOID DEPENDENCY BY ADMINISTERING BUPRENORPHINE ONCE PER MONTH
300MG/1.5ML (200MG/ML) SUBLOCADE INDIVIOR N209819 Nov. 30, 2017 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS 9827241 June 6, 2031 TREATING OPIOID DEPENDENCY BY SUBCUTANEOUSLY ADMINISTERING BUPRENORPHINE
100MG/0.5ML (100MG/0.5ML) SUBLOCADE INDIVIOR N209819 Nov. 30, 2017 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS 8975270 Sept. 5, 2031 TREATING OPIOID DEPENDENCY BY ADMINISTERING BUPRENORPHINE
100MG/0.5ML (100MG/0.5ML) SUBLOCADE INDIVIOR N209819 Nov. 30, 2017 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS 8975270 Sept. 5, 2031 TREATING OPIOID DEPENDENCY BY ADMINISTERING BUPRENORPHINE ONCE MONTHLY
300MG/1.5ML (200MG/ML) SUBLOCADE INDIVIOR N209819 Nov. 30, 2017 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS 8975270 Sept. 5, 2031 TREATING OPIOID DEPENDENCY BY ADMINISTERING BUPRENORPHINE
300MG/1.5ML (200MG/ML) SUBLOCADE INDIVIOR N209819 Nov. 30, 2017 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS 8975270 Sept. 5, 2031 TREATING OPIOID DEPENDENCY BY ADMINISTERING BUPRENORPHINE ONCE MONTHLY
100MG/0.5ML (100MG/0.5ML) SUBLOCADE INDIVIOR N209819 Nov. 30, 2017 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS 8921387 Jan. 6, 2032 TREATING OPIOID DEPENDENCE BY ADMINISTERING BUPRENORPHINE
100MG/0.5ML (100MG/0.5ML) SUBLOCADE INDIVIOR N209819 Nov. 30, 2017 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS 8921387 Jan. 6, 2032 TREATING OPIOID DEPENDENCY BY ADMINISTERING BUPRENORPHINE ONCE PER MONTH
300MG/1.5ML (200MG/ML) SUBLOCADE INDIVIOR N209819 Nov. 30, 2017 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS 8921387 Jan. 6, 2032 TREATING OPIOID DEPENDENCE BY ADMINISTERING BUPRENORPHINE
300MG/1.5ML (200MG/ML) SUBLOCADE INDIVIOR N209819 Nov. 30, 2017 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS 8921387 Jan. 6, 2032 TREATING OPIOID DEPENDENCY BY ADMINISTERING BUPRENORPHINE ONCE PER MONTH
128MG/0.36ML (356MG/ML) BRIXADI BRAEBURN N210136 May 23, 2023 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS 10912772 July 26, 2032 A METHOD OF ADMINISTERING AN OPIOID MAINTENANCE TREATMENT COMPRISING BUPRENORPHINE. A METHOD OF TREATING OPIOID WITHDRAWAL USING AN OPIOID MAINTENANCE TREATMENT COMPRISING BUPRENORPHINE
128MG/0.36ML (356MG/ML) BRIXADI BRAEBURN N210136 May 23, 2023 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS 11110084 July 26, 2032 A METHOD OF ADMINISTERING AN OPIOID MAINTENANCE TREATMENT COMPRISING BUPRENORPHINE
128MG/0.36ML (356MG/ML) BRIXADI BRAEBURN N210136 May 23, 2023 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS 12161640 July 26, 2032 A METHOD OF TREATING MODERATE TO SEVERE OPIOID USE DISORDER BY ADMINISTERING BUPRENORPHINE ONCE WEEKLY
128MG/0.36ML (356MG/ML) BRIXADI BRAEBURN N210136 May 23, 2023 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS 12318379 July 26, 2032 A METHOD OF TREATING MODERATE TO SEVERE OPIOID USE DISORDER BY ADMINISTERING BUPRENORPHINE ONCE WEEKLY
128MG/0.36ML (356MG/ML) BRIXADI BRAEBURN N210136 May 23, 2023 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS 9937164 July 26, 2032 A METHOD OF SUSTAINED DELIVERY OF BUPRENORPHINE TO A HUMAN OR NON-HUMAN ANIMAL BODY. A METHOD FOR TREATMENT FOR OPIOID MAINTENANCE THERAPY
16MG/0.32ML (50MG/ML) BRIXADI BRAEBURN N210136 May 23, 2023 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS 10912772 July 26, 2032 A METHOD OF ADMINISTERING AN OPIOID MAINTENANCE TREATMENT COMPRISING BUPRENORPHINE. A METHOD OF TREATING OPIOID WITHDRAWAL USING AN OPIOID MAINTENANCE TREATMENT COMPRISING BUPRENORPHINE
16MG/0.32ML (50MG/ML) BRIXADI BRAEBURN N210136 May 23, 2023 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS 11110084 July 26, 2032 A METHOD OF ADMINISTERING AN OPIOID MAINTENANCE TREATMENT COMPRISING BUPRENORPHINE
16MG/0.32ML (50MG/ML) BRIXADI BRAEBURN N210136 May 23, 2023 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS 12161640 July 26, 2032 A METHOD OF TREATING MODERATE TO SEVERE OPIOID USE DISORDER BY ADMINISTERING BUPRENORPHINE ONCE WEEKLY
16MG/0.32ML (50MG/ML) BRIXADI BRAEBURN N210136 May 23, 2023 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS 12318379 July 26, 2032 A METHOD OF TREATING MODERATE TO SEVERE OPIOID USE DISORDER BY ADMINISTERING BUPRENORPHINE ONCE WEEKLY
16MG/0.32ML (50MG/ML) BRIXADI BRAEBURN N210136 May 23, 2023 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS 9937164 July 26, 2032 A METHOD OF SUSTAINED DELIVERY OF BUPRENORPHINE TO A HUMAN OR NON-HUMAN ANIMAL BODY. A METHOD FOR TREATMENT FOR OPIOID MAINTENANCE THERAPY
24MG/0.48ML (50MG/ML) BRIXADI BRAEBURN N210136 May 23, 2023 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS 10912772 July 26, 2032 A METHOD OF ADMINISTERING AN OPIOID MAINTENANCE TREATMENT COMPRISING BUPRENORPHINE. A METHOD OF TREATING OPIOID WITHDRAWAL USING AN OPIOID MAINTENANCE TREATMENT COMPRISING BUPRENORPHINE
24MG/0.48ML (50MG/ML) BRIXADI BRAEBURN N210136 May 23, 2023 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS 11110084 July 26, 2032 A METHOD OF ADMINISTERING AN OPIOID MAINTENANCE TREATMENT COMPRISING BUPRENORPHINE
24MG/0.48ML (50MG/ML) BRIXADI BRAEBURN N210136 May 23, 2023 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS 12161640 July 26, 2032 A METHOD OF TREATING MODERATE TO SEVERE OPIOID USE DISORDER BY ADMINISTERING BUPRENORPHINE ONCE WEEKLY
24MG/0.48ML (50MG/ML) BRIXADI BRAEBURN N210136 May 23, 2023 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS 12318379 July 26, 2032 A METHOD OF TREATING MODERATE TO SEVERE OPIOID USE DISORDER BY ADMINISTERING BUPRENORPHINE ONCE WEEKLY
24MG/0.48ML (50MG/ML) BRIXADI BRAEBURN N210136 May 23, 2023 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS 9937164 July 26, 2032 A METHOD OF SUSTAINED DELIVERY OF BUPRENORPHINE TO A HUMAN OR NON-HUMAN ANIMAL BODY. A METHOD FOR TREATMENT FOR OPIOID MAINTENANCE THERAPY
32MG/0.64ML (50MG/ML) BRIXADI BRAEBURN N210136 May 23, 2023 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS 10912772 July 26, 2032 A METHOD OF ADMINISTERING AN OPIOID MAINTENANCE TREATMENT COMPRISING BUPRENORPHINE. A METHOD OF TREATING OPIOID WITHDRAWAL USING AN OPIOID MAINTENANCE TREATMENT COMPRISING BUPRENORPHINE
32MG/0.64ML (50MG/ML) BRIXADI BRAEBURN N210136 May 23, 2023 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS 11110084 July 26, 2032 A METHOD OF ADMINISTERING AN OPIOID MAINTENANCE TREATMENT COMPRISING BUPRENORPHINE
32MG/0.64ML (50MG/ML) BRIXADI BRAEBURN N210136 May 23, 2023 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS 12161640 July 26, 2032 A METHOD OF TREATING MODERATE TO SEVERE OPIOID USE DISORDER BY ADMINISTERING BUPRENORPHINE ONCE WEEKLY
32MG/0.64ML (50MG/ML) BRIXADI BRAEBURN N210136 May 23, 2023 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS 12318379 July 26, 2032 A METHOD OF TREATING MODERATE TO SEVERE OPIOID USE DISORDER BY ADMINISTERING BUPRENORPHINE ONCE WEEKLY
32MG/0.64ML (50MG/ML) BRIXADI BRAEBURN N210136 May 23, 2023 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS 9937164 July 26, 2032 A METHOD OF SUSTAINED DELIVERY OF BUPRENORPHINE TO A HUMAN OR NON-HUMAN ANIMAL BODY. A METHOD FOR TREATMENT FOR OPIOID MAINTENANCE THERAPY
64MG/0.18ML (356MG/ML) BRIXADI BRAEBURN N210136 May 23, 2023 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS 10912772 July 26, 2032 A METHOD OF ADMINISTERING AN OPIOID MAINTENANCE TREATMENT COMPRISING BUPRENORPHINE. A METHOD OF TREATING OPIOID WITHDRAWAL USING AN OPIOID MAINTENANCE TREATMENT COMPRISING BUPRENORPHINE
64MG/0.18ML (356MG/ML) BRIXADI BRAEBURN N210136 May 23, 2023 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS 11110084 July 26, 2032 A METHOD OF ADMINISTERING AN OPIOID MAINTENANCE TREATMENT COMPRISING BUPRENORPHINE
64MG/0.18ML (356MG/ML) BRIXADI BRAEBURN N210136 May 23, 2023 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS 12161640 July 26, 2032 A METHOD OF TREATING MODERATE TO SEVERE OPIOID USE DISORDER BY ADMINISTERING BUPRENORPHINE ONCE WEEKLY
64MG/0.18ML (356MG/ML) BRIXADI BRAEBURN N210136 May 23, 2023 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS 12318379 July 26, 2032 A METHOD OF TREATING MODERATE TO SEVERE OPIOID USE DISORDER BY ADMINISTERING BUPRENORPHINE ONCE WEEKLY
64MG/0.18ML (356MG/ML) BRIXADI BRAEBURN N210136 May 23, 2023 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS 9937164 July 26, 2032 A METHOD OF SUSTAINED DELIVERY OF BUPRENORPHINE TO A HUMAN OR NON-HUMAN ANIMAL BODY. A METHOD FOR TREATMENT FOR OPIOID MAINTENANCE THERAPY
8MG/0.16ML (50MG/ML) BRIXADI BRAEBURN N210136 May 23, 2023 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS 10912772 July 26, 2032 A METHOD OF ADMINISTERING AN OPIOID MAINTENANCE TREATMENT COMPRISING BUPRENORPHINE. A METHOD OF TREATING OPIOID WITHDRAWAL USING AN OPIOID MAINTENANCE TREATMENT COMPRISING BUPRENORPHINE
8MG/0.16ML (50MG/ML) BRIXADI BRAEBURN N210136 May 23, 2023 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS 11110084 July 26, 2032 A METHOD OF ADMINISTERING AN OPIOID MAINTENANCE TREATMENT COMPRISING BUPRENORPHINE
8MG/0.16ML (50MG/ML) BRIXADI BRAEBURN N210136 May 23, 2023 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS 12161640 July 26, 2032 A METHOD OF TREATING MODERATE TO SEVERE OPIOID USE DISORDER BY ADMINISTERING BUPRENORPHINE ONCE WEEKLY
8MG/0.16ML (50MG/ML) BRIXADI BRAEBURN N210136 May 23, 2023 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS 12318379 July 26, 2032 A METHOD OF TREATING MODERATE TO SEVERE OPIOID USE DISORDER BY ADMINISTERING BUPRENORPHINE ONCE WEEKLY
8MG/0.16ML (50MG/ML) BRIXADI BRAEBURN N210136 May 23, 2023 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS 9937164 July 26, 2032 A METHOD OF SUSTAINED DELIVERY OF BUPRENORPHINE TO A HUMAN OR NON-HUMAN ANIMAL BODY. A METHOD FOR TREATMENT FOR OPIOID MAINTENANCE THERAPY
96MG/0.27ML (356MG/ML) BRIXADI BRAEBURN N210136 May 23, 2023 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS 10912772 July 26, 2032 A METHOD OF ADMINISTERING AN OPIOID MAINTENANCE TREATMENT COMPRISING BUPRENORPHINE. A METHOD OF TREATING OPIOID WITHDRAWAL USING AN OPIOID MAINTENANCE TREATMENT COMPRISING BUPRENORPHINE
96MG/0.27ML (356MG/ML) BRIXADI BRAEBURN N210136 May 23, 2023 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS 11110084 July 26, 2032 A METHOD OF ADMINISTERING AN OPIOID MAINTENANCE TREATMENT COMPRISING BUPRENORPHINE
96MG/0.27ML (356MG/ML) BRIXADI BRAEBURN N210136 May 23, 2023 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS 12161640 July 26, 2032 A METHOD OF TREATING MODERATE TO SEVERE OPIOID USE DISORDER BY ADMINISTERING BUPRENORPHINE ONCE WEEKLY
96MG/0.27ML (356MG/ML) BRIXADI BRAEBURN N210136 May 23, 2023 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS 12318379 July 26, 2032 A METHOD OF TREATING MODERATE TO SEVERE OPIOID USE DISORDER BY ADMINISTERING BUPRENORPHINE ONCE WEEKLY
96MG/0.27ML (356MG/ML) BRIXADI BRAEBURN N210136 May 23, 2023 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS 9937164 July 26, 2032 A METHOD OF SUSTAINED DELIVERY OF BUPRENORPHINE TO A HUMAN OR NON-HUMAN ANIMAL BODY. A METHOD FOR TREATMENT FOR OPIOID MAINTENANCE THERAPY
EQ 0.7MG BASE;EQ 0.18MG BASE ZUBSOLV EDENBRIDGE PHARMS N204242 Oct. 4, 2016 RX TABLET SUBLINGUAL 11020388 Sept. 18, 2032 USE OF ZUBSOLV FOR TREATMENT OF OPIOID DEPENDENCE
EQ 1.4MG BASE;EQ 0.36MG BASE ZUBSOLV EDENBRIDGE PHARMS N204242 July 3, 2013 RX TABLET SUBLINGUAL 11020388 Sept. 18, 2032 USE OF ZUBSOLV FOR TREATMENT OF OPIOID DEPENDENCE
EQ 1.4MG BASE;EQ 0.36MG BASE ZUBSOLV EDENBRIDGE PHARMS N204242 July 3, 2013 RX TABLET SUBLINGUAL 11433066 Sept. 18, 2032 USE OF ZUBSOLV FOR TREATMENT OF OPIOID DEPENDENCE
EQ 11.4MG BASE;EQ 2.9MG BASE ZUBSOLV EDENBRIDGE PHARMS N204242 Dec. 11, 2014 RX TABLET SUBLINGUAL 11020387 Sept. 18, 2032 USE OF ZUBSOLV FOR TREATMENT OF OPIOID DEPENDENCE
EQ 11.4MG BASE;EQ 2.9MG BASE ZUBSOLV EDENBRIDGE PHARMS N204242 Dec. 11, 2014 RX TABLET SUBLINGUAL 11020388 Sept. 18, 2032 USE OF ZUBSOLV FOR TREATMENT OF OPIOID DEPENDENCE
EQ 11.4MG BASE;EQ 2.9MG BASE ZUBSOLV EDENBRIDGE PHARMS N204242 Dec. 11, 2014 RX TABLET SUBLINGUAL 11433066 Sept. 18, 2032 USE OF ZUBSOLV FOR TREATMENT OF OPIOID DEPENDENCE
EQ 2.9MG BASE;EQ 0.71MG BASE ZUBSOLV EDENBRIDGE PHARMS N204242 June 4, 2015 RX TABLET SUBLINGUAL 11020387 Sept. 18, 2032 USE OF ZUBSOLV FOR TREATMENT OF OPIOID DEPENDENCE
EQ 2.9MG BASE;EQ 0.71MG BASE ZUBSOLV EDENBRIDGE PHARMS N204242 June 4, 2015 RX TABLET SUBLINGUAL 11020388 Sept. 18, 2032 USE OF ZUBSOLV FOR TREATMENT OF OPIOID DEPENDENCE
EQ 2.9MG BASE;EQ 0.71MG BASE ZUBSOLV EDENBRIDGE PHARMS N204242 June 4, 2015 RX TABLET SUBLINGUAL 11433066 Sept. 18, 2032 USE OF ZUBSOLV FOR TREATMENT OF OPIOID DEPENDENCE
EQ 5.7MG BASE;EQ 1.4MG BASE ZUBSOLV EDENBRIDGE PHARMS N204242 July 3, 2013 RX TABLET SUBLINGUAL 11020387 Sept. 18, 2032 USE OF ZUBSOLV FOR TREATMENT OF OPIOID DEPENDENCE
EQ 5.7MG BASE;EQ 1.4MG BASE ZUBSOLV EDENBRIDGE PHARMS N204242 July 3, 2013 RX TABLET SUBLINGUAL 11020388 Sept. 18, 2032 USE OF ZUBSOLV FOR TREATMENT OF OPIOID DEPENDENCE
EQ 5.7MG BASE;EQ 1.4MG BASE ZUBSOLV EDENBRIDGE PHARMS N204242 July 3, 2013 RX TABLET SUBLINGUAL 11433066 Sept. 18, 2032 USE OF ZUBSOLV FOR TREATMENT OF OPIOID DEPENDENCE
EQ 8.6MG BASE;EQ 2.1MG BASE ZUBSOLV EDENBRIDGE PHARMS N204242 Dec. 11, 2014 RX TABLET SUBLINGUAL 11020387 Sept. 18, 2032 USE OF ZUBSOLV FOR TREATMENT OF OPIOID DEPENDENCE
EQ 8.6MG BASE;EQ 2.1MG BASE ZUBSOLV EDENBRIDGE PHARMS N204242 Dec. 11, 2014 RX TABLET SUBLINGUAL 11020388 Sept. 18, 2032 USE OF ZUBSOLV FOR TREATMENT OF OPIOID DEPENDENCE
EQ 8.6MG BASE;EQ 2.1MG BASE ZUBSOLV EDENBRIDGE PHARMS N204242 Dec. 11, 2014 RX TABLET SUBLINGUAL 11433066 Sept. 18, 2032 USE OF ZUBSOLV FOR TREATMENT OF OPIOID DEPENDENCE
EQ 0.075MG BASE BELBUCA BDSI N207932 Oct. 23, 2015 RX FILM BUCCAL 9901539 Dec. 21, 2032 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
EQ 0.15MG BASE BELBUCA BDSI N207932 Oct. 23, 2015 RX FILM BUCCAL 9901539 Dec. 21, 2032 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
EQ 0.3MG BASE BELBUCA BDSI N207932 Oct. 23, 2015 RX FILM BUCCAL 9901539 Dec. 21, 2032 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
EQ 0.45MG BASE BELBUCA BDSI N207932 Oct. 23, 2015 RX FILM BUCCAL 9901539 Dec. 21, 2032 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
EQ 0.6MG BASE BELBUCA BDSI N207932 Oct. 23, 2015 RX FILM BUCCAL 9901539 Dec. 21, 2032 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
EQ 0.75MG BASE BELBUCA BDSI N207932 Oct. 23, 2015 RX FILM BUCCAL 9901539 Dec. 21, 2032 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
EQ 0.9MG BASE BELBUCA BDSI N207932 Oct. 23, 2015 RX FILM BUCCAL 9901539 Dec. 21, 2032 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
100MG/0.5ML (100MG/0.5ML) SUBLOCADE INDIVIOR N209819 Nov. 30, 2017 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS 11000520 Nov. 6, 2035 TREATING OPIOID USE DISORDER
100MG/0.5ML (100MG/0.5ML) SUBLOCADE INDIVIOR N209819 Nov. 30, 2017 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS 11839611 Nov. 6, 2035 TREATING OPIOID USE DISORDER
100MG/0.5ML (100MG/0.5ML) SUBLOCADE INDIVIOR N209819 Nov. 30, 2017 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS 12622904 Nov. 6, 2035 TREATMENT OF MODERATE TO SEVERE OPIOID USE DISORDER BY ONCE-MONTHLY SUBCUTANEOUS ADMINISTRATION OF BUPRENORPHINE FREE BASE
300MG/1.5ML (200MG/ML) SUBLOCADE INDIVIOR N209819 Nov. 30, 2017 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS 11000520 Nov. 6, 2035 TREATING OPIOID USE DISORDER
300MG/1.5ML (200MG/ML) SUBLOCADE INDIVIOR N209819 Nov. 30, 2017 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS 11839611 Nov. 6, 2035 TREATING OPIOID USE DISORDER
300MG/1.5ML (200MG/ML) SUBLOCADE INDIVIOR N209819 Nov. 30, 2017 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS 12622904 Nov. 6, 2035 TREATMENT OF MODERATE TO SEVERE OPIOID USE DISORDER BY ONCE-MONTHLY SUBCUTANEOUS ADMINISTRATION OF BUPRENORPHINE FREE BASE
300MG/1.5ML (200MG/ML) SUBLOCADE INDIVIOR N209819 Nov. 30, 2017 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS 10646484 June 22, 2038 TREATMENT OF MODERATE TO SEVERE OPIOID USE DISORDER

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
128MG/0.36ML (356MG/ML) BRIXADI BRAEBURN N210136 May 23, 2023 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS May 23, 2026 NEW PRODUCT
16MG/0.32ML (50MG/ML) BRIXADI BRAEBURN N210136 May 23, 2023 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS May 23, 2026 NEW PRODUCT
24MG/0.48ML (50MG/ML) BRIXADI BRAEBURN N210136 May 23, 2023 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS May 23, 2026 NEW PRODUCT
32MG/0.64ML (50MG/ML) BRIXADI BRAEBURN N210136 May 23, 2023 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS May 23, 2026 NEW PRODUCT
64MG/0.18ML (356MG/ML) BRIXADI BRAEBURN N210136 May 23, 2023 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS May 23, 2026 NEW PRODUCT
8MG/0.16ML (50MG/ML) BRIXADI BRAEBURN N210136 May 23, 2023 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS May 23, 2026 NEW PRODUCT
96MG/0.27ML (356MG/ML) BRIXADI BRAEBURN N210136 May 23, 2023 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS May 23, 2026 NEW PRODUCT
100MG/0.5ML (100MG/0.5ML) SUBLOCADE INDIVIOR N209819 Nov. 30, 2017 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS Feb. 21, 2028 UPDATES TO THE PRESCRIBING INFORMATION BASED ON RESULTS OF CLINICAL STUDIES
300MG/1.5ML (200MG/ML) SUBLOCADE INDIVIOR N209819 Nov. 30, 2017 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS Feb. 21, 2028 UPDATES TO THE PRESCRIBING INFORMATION BASED ON RESULTS OF CLINICAL STUDIES

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])		Mechanism
action		Bioact sourceMoA source
Kappa-type opioid receptor GPCR ANTAGONIST Ki 9.01 WOMBAT-PK CHEMBL
Mu-type opioid receptor GPCR PARTIAL AGONIST Ki 8.29 WOMBAT-PK CHEMBL
Delta-type opioid receptor GPCR ANTAGONIST Ki 8.07 WOMBAT-PK
Nociceptin receptor GPCR Ki 7.11 CHEMBL
Potassium voltage-gated channel subfamily H member 2 Ion channel IC50 5.10 CHEMBL
Mu-type opioid receptor GPCR Ki 9.89 CHEMBL
Mu-type opioid receptor GPCR Ki 9.40 CHEMBL
Delta-type opioid receptor GPCR Ki 9.32 CHEMBL
Kappa-type opioid receptor GPCR Ki 9.30 CHEMBL

External reference:

IDSource
4019644 VUID
N0000147737 NUI
D00836 KEGG_DRUG
53152-21-9 SECONDARY_CAS_RN
1819 RXNORM
C0006405 UMLSCUI
CHEBI:3216 CHEBI
CHEMBL511142 ChEMBL_ID
CHEMBL2368861 ChEMBL_ID
D002047 MESH_DESCRIPTOR_UI
DB00921 DRUGBANK_ID
1670 IUPHAR_LIGAND_ID
3403 INN_ID
40D3SCR4GZ UNII
644073 PUBCHEM_CID
11186 MMSL
257949 MMSL
27271 MMSL
31700 MMSL
4306 MMSL
d00840 MMSL
21066009 SNOMEDCT_US
31684002 SNOMEDCT_US
387173000 SNOMEDCT_US
4018880 VANDF
4019644 VANDF
001573 NDDF
004632 NDDF
40D3SCR4GZ INXIGHT DRUGS

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Buprenorphine HUMAN PRESCRIPTION DRUG LABEL 1 0054-0176 TABLET 2 mg SUBLINGUAL ANDA 33 sections
Buprenorphine HUMAN PRESCRIPTION DRUG LABEL 1 0054-0176 TABLET 2 mg SUBLINGUAL ANDA 33 sections
Buprenorphine HUMAN PRESCRIPTION DRUG LABEL 1 0054-0177 TABLET 8 mg SUBLINGUAL ANDA 33 sections
Buprenorphine HUMAN PRESCRIPTION DRUG LABEL 1 0054-0177 TABLET 8 mg SUBLINGUAL ANDA 33 sections
buprenorphine hydrochloride and naloxone hydrochloride dihydrate HUMAN PRESCRIPTION DRUG LABEL 2 0054-0188 TABLET 2 mg SUBLINGUAL ANDA 33 sections
buprenorphine hydrochloride and naloxone hydrochloride dihydrate HUMAN PRESCRIPTION DRUG LABEL 2 0054-0188 TABLET 2 mg SUBLINGUAL ANDA 33 sections
buprenorphine hydrochloride and naloxone hydrochloride dihydrate HUMAN PRESCRIPTION DRUG LABEL 2 0054-0189 TABLET 8 mg SUBLINGUAL ANDA 33 sections
buprenorphine hydrochloride and naloxone hydrochloride dihydrate HUMAN PRESCRIPTION DRUG LABEL 2 0054-0189 TABLET 8 mg SUBLINGUAL ANDA 33 sections
Buprenorphine HUMAN PRESCRIPTION DRUG LABEL 1 0093-3239 PATCH, EXTENDED RELEASE 7.50 ug TRANSDERMAL ANDA 31 sections
Buprenorphine HUMAN PRESCRIPTION DRUG LABEL 1 0093-3656 PATCH, EXTENDED RELEASE 5 ug TRANSDERMAL ANDA 31 sections
Buprenorphine HUMAN PRESCRIPTION DRUG LABEL 1 0093-3657 PATCH, EXTENDED RELEASE 10 ug TRANSDERMAL ANDA 31 sections
Buprenorphine HUMAN PRESCRIPTION DRUG LABEL 1 0093-3658 PATCH, EXTENDED RELEASE 15 ug TRANSDERMAL ANDA 31 sections
Buprenorphine HUMAN PRESCRIPTION DRUG LABEL 1 0093-3659 PATCH, EXTENDED RELEASE 20 ug TRANSDERMAL ANDA 31 sections
Buprenorphine and Naloxone HUMAN PRESCRIPTION DRUG LABEL 2 0121-1018 TABLET 2 mg SUBLINGUAL ANDA 31 sections
buprenorphine hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0121-1019 TABLET 2 mg SUBLINGUAL ANDA 33 sections
Buprenorphine and Naloxone HUMAN PRESCRIPTION DRUG LABEL 2 0121-2036 TABLET 8 mg SUBLINGUAL ANDA 31 sections
buprenorphine hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0121-2038 TABLET 8 mg SUBLINGUAL ANDA 33 sections
Buprenorphine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0143-9246 INJECTION 0.32 mg INTRAMUSCULAR ANDA 16 sections
Buprenorphine HUMAN PRESCRIPTION DRUG LABEL 1 0228-3153 TABLET 8 mg SUBLINGUAL ANDA 32 sections
Buprenorphine and Naloxone HUMAN PRESCRIPTION DRUG LABEL 2 0228-3154 TABLET 2 mg SUBLINGUAL ANDA 33 sections
Buprenorphine and Naloxone HUMAN PRESCRIPTION DRUG LABEL 2 0228-3155 TABLET 8 mg SUBLINGUAL ANDA 33 sections
Buprenorphine HUMAN PRESCRIPTION DRUG LABEL 1 0228-3156 TABLET 2 mg SUBLINGUAL ANDA 32 sections
Buprenorphine and Naloxone HUMAN PRESCRIPTION DRUG LABEL 2 0378-8765 FILM 2 mg SUBLINGUAL ANDA 34 sections
Buprenorphine and Naloxone HUMAN PRESCRIPTION DRUG LABEL 2 0378-8766 FILM 4 mg SUBLINGUAL ANDA 34 sections
Buprenorphine and Naloxone HUMAN PRESCRIPTION DRUG LABEL 2 0378-8767 FILM 8 mg SUBLINGUAL ANDA 34 sections
Buprenorphine and Naloxone HUMAN PRESCRIPTION DRUG LABEL 2 0378-8768 FILM 12 mg SUBLINGUAL ANDA 34 sections
Buprenorphine HCl HUMAN PRESCRIPTION DRUG LABEL 1 0406-7012 TABLET 2 mg SUBLINGUAL ANDA 36 sections
Buprenorphine HCl HUMAN PRESCRIPTION DRUG LABEL 1 0406-7018 TABLET 8 mg SUBLINGUAL ANDA 36 sections
Buprenorphine Hydrochloride and Naloxone Hydrochloride Dihydrate HUMAN PRESCRIPTION DRUG LABEL 2 0406-8005 TABLET 2 mg SUBLINGUAL ANDA 37 sections
Buprenorphine Hydrochloride and Naloxone Hydrochloride Dihydrate HUMAN PRESCRIPTION DRUG LABEL 2 0406-8020 TABLET 8 mg SUBLINGUAL ANDA 37 sections