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

Stem definitionDrug idCAS RN
opioid receptor agonists, analgesics, fentanyl derivatives 1164 437-38-7

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • fentanyl
  • fentanil
  • fentanyl citrate
  • effentora
  • instanyl
  • fentanyl hydrochloride
  • fentanyl HCl
A potent narcotic analgesic, abuse of which leads to habituation or addiction. It is primarily a mu-opioid agonist. Fentanyl is also used as an adjunct to general anesthetics, and as an anesthetic for induction and maintenance.
  • Molecular weight: 336.48
  • Formula: C22H28N2O
  • CLOGP: 3.62
  • LIPINSKI: 0
  • HAC: 3
  • HDO: 0
  • TPSA: 23.55
  • ALOGS: -4.15
  • ROTB: 6

Drug dosage:

DoseUnitRoute
0.60 mg N
0.60 mg SL
1.20 mg TD

Approvals:

DateAgencyCompanyOrphan
Feb. 19, 1968 FDA AKORN

FDA Adverse Event Reporting System

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Toxicity to various agents 6963.37 31.20 2176 14908 44878 3323897
Drug abuse 5141.11 31.20 1400 15684 16930 3351845
Death 2963.06 31.20 1659 15425 150665 3218110
Overdose 2844.85 31.20 1033 16051 32945 3335830
Product quality issue 2403.93 31.20 858 16226 25877 3342898
Accidental overdose 2376.63 31.20 627 16457 6491 3362284
Intentional product misuse 1967.07 31.20 615 16469 12086 3356689
Wrong technique in product usage process 1706.09 31.20 591 16493 16160 3352615
Cardio-respiratory arrest 1442.00 31.20 511 16573 14929 3353846
Somnolence 1431.95 31.20 622 16462 31582 3337193
Cardiac arrest 1400.99 31.20 584 16500 26735 3342040
Drug prescribing error 1388.42 31.20 368 16716 3852 3364923
Respiratory arrest 1380.00 31.20 458 16626 10910 3357865
Respiratory depression 1316.96 31.20 346 16738 3488 3365287
Serotonin syndrome 1238.43 31.20 355 16729 5068 3363707
Drug withdrawal syndrome 1129.71 31.20 398 16686 11387 3357388
Inadequate analgesia 1126.52 31.20 246 16838 1003 3367772
Drug ineffective 992.26 31.20 763 16321 115327 3253448
Product adhesion issue 955.58 31.20 227 16857 1443 3367332
Completed suicide 948.35 31.20 463 16621 30651 3338124
Pain 875.67 31.20 586 16498 70971 3297804
Unresponsive to stimuli 873.33 31.20 298 16786 7710 3361065
Hypotension 769.73 31.20 472 16612 49042 3319733
Nausea 766.42 31.20 689 16395 128956 3239819
Neoplasm progression 678.21 31.20 222 16862 5022 3363753
Drug interaction 670.97 31.20 424 16660 46388 3322387
Vomiting 658.39 31.20 540 16544 88991 3279784
Medication error 600.51 31.20 252 16832 11619 3357156
Miosis 586.23 31.20 161 16923 1935 3366840
Incorrect route of drug administration 583.31 31.20 230 16854 9013 3359762
Coma 577.08 31.20 249 16835 12303 3356472
Delirium 570.74 31.20 229 16855 9399 3359376
Poisoning 567.77 31.20 193 16891 4919 3363856
Drug effect decreased 565.25 31.20 242 16842 11727 3357048
Withdrawal syndrome 551.90 31.20 182 16902 4212 3364563
Oxygen saturation decreased 543.28 31.20 224 16860 9867 3358908
Post procedural complication 524.35 31.20 181 16903 4836 3363939
Accidental exposure to product by child 515.99 31.20 134 16950 1277 3367498
Depressed level of consciousness 512.44 31.20 223 16861 11242 3357533
Bradycardia 506.50 31.20 248 16836 16421 3352354
Loss of consciousness 503.01 31.20 294 16790 27853 3340922
Inappropriate schedule of drug administration 498.38 31.20 231 16853 13522 3355253
Drug hypersensitivity 497.68 31.20 318 16766 35362 3333413
Malignant neoplasm progression 497.03 31.20 250 16834 17543 3351232
Hyperhidrosis 495.57 31.20 274 16810 23336 3345439
Accidental death 494.16 31.20 111 16973 527 3368248
Apnoea 491.86 31.20 146 16938 2356 3366419
Confusional state 486.67 31.20 321 16763 37677 3331098
Sedation 478.72 31.20 178 16906 5923 3362852
Pulmonary oedema 472.21 31.20 213 16871 11698 3357077
Drug dependence 469.41 31.20 161 16923 4215 3364560
Agitation 436.35 31.20 237 16847 19469 3349306
Anaphylactic reaction 416.82 31.20 201 16883 12853 3355922
Constipation 403.29 31.20 264 16820 30548 3338227
Off label use 379.56 31.20 318 16766 53659 3315116
Drug abuser 371.86 31.20 120 16964 2583 3366192
Hyperaesthesia 342.25 31.20 100 16984 1521 3367254
Tachycardia 332.16 31.20 211 16873 23160 3345615
Application site rash 327.58 31.20 89 16995 1022 3367753
Respiratory rate decreased 307.20 31.20 81 17003 822 3367953
Application site erythema 305.82 31.20 97 16987 1970 3366805
Lethargy 305.71 31.20 167 16917 13848 3354927
Application site pruritus 303.41 31.20 89 16995 1373 3367402
Mental status changes 287.24 31.20 144 16940 10003 3358772
Drug diversion 280.49 31.20 65 17019 363 3368412
Anaesthetic complication 274.63 31.20 72 17012 713 3368062
Hypoxia 266.89 31.20 135 16949 9556 3359219
Drug administration error 260.54 31.20 116 16968 6160 3362615
Mental status changes postoperative 260.22 31.20 45 17039 23 3368752
Muscle rigidity 258.09 31.20 94 16990 2940 3365835
Myoclonus 249.53 31.20 98 16986 3785 3364990
Delayed recovery from anaesthesia 239.52 31.20 54 17030 261 3368514
Respiratory failure 228.76 31.20 167 16917 22974 3345801
Blood pressure decreased 227.07 31.20 137 16947 13699 3355076
Hallucination 218.68 31.20 132 16952 13208 3355567
Incorrect dose administered 213.55 31.20 132 16952 13782 3354993
Therapeutic response unexpected 212.82 31.20 95 16989 5073 3363702
Application site reaction 212.64 31.20 56 17028 565 3368210
Application site irritation 209.71 31.20 59 17025 777 3367998
Accidental exposure to product 203.46 31.20 90 16994 4702 3364073
Drug dose omission 203.22 31.20 193 16891 38239 3330536
Exposure during pregnancy 196.60 31.20 164 16920 27399 3341376
Dizziness 194.01 31.20 262 16822 76250 3292525
Product administered at inappropriate site 192.41 31.20 59 17025 1066 3367709
Dyspnoea 192.24 31.20 305 16779 102629 3266146
Seizure 189.49 31.20 190 16894 40210 3328565
Hypoventilation 187.66 31.20 57 17027 996 3367779
Drug effect increased 187.08 31.20 49 17035 483 3368292
Breakthrough pain 184.95 31.20 44 17040 280 3368495
Application site vesicles 174.31 31.20 49 17035 643 3368132
Dental caries 173.68 31.20 66 17018 2327 3366448
Application site pain 173.47 31.20 60 17024 1607 3367168
Tremor 171.37 31.20 153 16931 27991 3340784
Adverse event 170.64 31.20 107 16977 11450 3357325
Stress cardiomyopathy 170.03 31.20 57 17027 1385 3367390
Intentional product use issue 169.24 31.20 61 17023 1849 3366926
Cyanosis 165.72 31.20 79 17005 4907 3363868
Pulmonary congestion 161.53 31.20 67 17017 2983 3365792
Procedural complication 159.23 31.20 61 17023 2199 3366576
Pulseless electrical activity 158.75 31.20 56 17028 1592 3367183
Disorientation 155.57 31.20 96 16988 9983 3358792
Drug screen positive 153.84 31.20 57 17027 1871 3366904
Sedation complication 145.72 31.20 27 17057 33 3368742
Incorrect drug administration duration 142.62 31.20 63 17021 3278 3365497
Cardiomegaly 141.93 31.20 68 17016 4270 3364505
Insomnia 139.92 31.20 153 16931 35745 3333030
Circulatory collapse 139.91 31.20 75 17009 5974 3362801
Hypertension 139.72 31.20 158 16926 38308 3330467
Maternal exposure during delivery 137.35 31.20 29 17055 96 3368679
Product counterfeit 135.97 31.20 32 17052 193 3368582
Drug use disorder 135.42 31.20 43 17041 875 3367900
Anxiety 132.54 31.20 156 16928 39473 3329302
Self-medication 131.35 31.20 45 17039 1170 3367605
Poor quality drug administered 130.85 31.20 44 17040 1079 3367696
Narcotic bowel syndrome 130.60 31.20 24 17060 27 3368748
Drug tolerance 130.27 31.20 39 17045 647 3368128
Heart rate increased 128.43 31.20 98 16986 14388 3354387
Intentional overdose 124.11 31.20 98 16986 15127 3353648
Rhabdomyolysis 121.29 31.20 98 16986 15631 3353144
Treatment noncompliance 120.05 31.20 78 17006 8867 3359908
Neoplasm malignant 119.56 31.20 76 17008 8321 3360454
Back pain 119.50 31.20 145 16939 37860 3330915
Horner's syndrome 117.75 31.20 26 17058 112 3368663
Respiratory acidosis 117.51 31.20 41 17043 1127 3367648
Dyskinesia 113.96 31.20 70 17014 7215 3361560
Bronchospasm 109.97 31.20 57 17027 4237 3364538
Fall 108.94 31.20 174 16910 58709 3310066
Maternal exposure during pregnancy 107.95 31.20 77 17007 10194 3358581
Brain injury 105.76 31.20 41 17043 1526 3367249
Therapeutic response decreased 105.13 31.20 77 17007 10621 3358154
Malaise 103.72 31.20 180 16904 64997 3303778
Counterfeit product administered 101.27 31.20 21 17063 62 3368713
Sinus tachycardia 100.33 31.20 56 17028 4829 3363946
Restlessness 100.15 31.20 65 17019 7373 3361402
Hospice care 99.96 31.20 32 17052 669 3368106
Bradycardia foetal 99.43 31.20 25 17059 206 3368569
Feeling abnormal 98.08 31.20 112 16972 27413 3341362
Pneumonia 97.94 31.20 183 16901 69960 3298815
Device leakage 97.92 31.20 37 17047 1283 3367492
Suicide attempt 94.10 31.20 85 16999 15762 3353013
Exposure via ingestion 93.49 31.20 37 17047 1456 3367319
Weight decreased 93.36 31.20 132 16952 39979 3328796
Respiratory distress 93.05 31.20 65 17019 8323 3360452
Hypoxic-ischaemic encephalopathy 92.73 31.20 37 17047 1488 3367287
Tooth loss 92.55 31.20 38 17046 1647 3367128
Respiratory disorder 92.27 31.20 57 17027 5933 3362842
Device failure 90.39 31.20 42 17042 2459 3366316
Asthenia 90.01 31.20 170 16914 65495 3303280
Product use issue 89.49 31.20 83 17001 15918 3352857
Potentiating drug interaction 88.91 31.20 32 17052 965 3367810
Abdominal pain 88.77 31.20 139 16945 46086 3322689
Product tampering 87.16 31.20 21 17063 142 3368633
Application site burn 86.78 31.20 25 17059 360 3368415
Hypersomnia 85.96 31.20 44 17040 3185 3365590
Foetal exposure during pregnancy 85.69 31.20 80 17004 15471 3353304
Atrial fibrillation 84.57 31.20 97 16987 23844 3344931
Hypopnoea 84.24 31.20 26 17058 480 3368295
Underdose 82.99 31.20 56 17028 6778 3361997
Dysarthria 82.79 31.20 64 17020 9570 3359205
Dermatitis contact 82.60 31.20 35 17049 1643 3367132
Condition aggravated 82.40 31.20 123 16961 39110 3329665
Hyperthermia malignant 81.92 31.20 26 17058 528 3368247
Muscle spasms 81.85 31.20 101 16983 26802 3341973
Blood pressure increased 81.80 31.20 92 16992 22138 3346637
Ventricular fibrillation 81.77 31.20 47 17037 4286 3364489
Dehydration 81.66 31.20 113 16971 33536 3335239
Aspiration 81.15 31.20 41 17043 2887 3365888
Dependence 80.83 31.20 27 17057 648 3368127
Neurotoxicity 80.73 31.20 43 17041 3378 3365397
Urinary retention 80.09 31.20 57 17027 7515 3361260
Chills 77.40 31.20 89 16995 21933 3346842
Hospitalisation 76.64 31.20 86 16998 20639 3348136
Drug screen negative 76.35 31.20 20 17064 197 3368578
Substance abuse 76.25 31.20 30 17054 1162 3367613
Pruritus 73.98 31.20 129 16955 46704 3322071
Ventricular tachycardia 73.49 31.20 49 17035 5813 3362962
Clonus 73.29 31.20 27 17057 871 3367904
Renal failure 71.64 31.20 105 16979 32835 3335940
Multiple organ dysfunction syndrome 71.55 31.20 70 17014 14340 3354435
Brain oedema 71.08 31.20 41 17043 3763 3365012
Dry mouth 71.08 31.20 59 17025 9763 3359012
Generalised tonic-clonic seizure 70.35 31.20 54 17030 7988 3360787
Bradypnoea 69.11 31.20 21 17063 367 3368408
Altered state of consciousness 67.10 31.20 46 17038 5712 3363063
Application site dermatitis 66.98 31.20 17 17067 146 3368629
Laryngospasm 66.95 31.20 26 17058 972 3367803
Product substitution issue 66.41 31.20 51 17033 7549 3361226
Therapy non-responder 66.17 31.20 59 17025 10750 3358025
Pulse absent 66.13 31.20 30 17054 1661 3367114
Skin irritation 65.59 31.20 30 17054 1693 3367082
Muscular weakness 64.50 31.20 78 17006 20263 3348512
Atelectasis 64.25 31.20 37 17047 3385 3365390
Sleep apnoea syndrome 64.17 31.20 37 17047 3393 3365382
Mydriasis 63.99 31.20 35 17049 2899 3365876
Labile blood pressure 63.92 31.20 19 17065 307 3368468
Abnormal behaviour 63.91 31.20 56 17028 9972 3358803
Heart rate decreased 63.48 31.20 43 17041 5235 3363540
Pneumonia aspiration 62.89 31.20 48 17036 7040 3361735
Anaphylactic shock 62.54 31.20 44 17040 5695 3363080
Depression 62.08 31.20 109 16975 39661 3329114
Fatigue 61.84 31.20 199 16885 107041 3261734
Haemodynamic instability 61.83 31.20 30 17054 1935 3366840
Pyrexia 61.55 31.20 166 16918 80949 3287826
Adverse drug reaction 61.36 31.20 53 17031 9258 3359517
Lung neoplasm malignant 60.75 31.20 42 17042 5286 3363489
Delusion 60.42 31.20 36 17048 3509 3365266
Kounis syndrome 60.27 31.20 20 17064 470 3368305
Blood urea increased 60.15 31.20 48 17036 7512 3361263
Pancreatic carcinoma 59.75 31.20 33 17051 2786 3365989
Decreased appetite 58.75 31.20 109 16975 41381 3327394
Confusion postoperative 57.72 31.20 12 17072 36 3368739
Faecaloma 57.64 31.20 25 17059 1243 3367532
Premature baby 57.60 31.20 46 17038 7207 3361568
Obstructive airways disorder 57.45 31.20 27 17057 1622 3367153
Areflexia 57.24 31.20 23 17061 942 3367833
Caesarean section 57.14 31.20 38 17046 4488 3364287
Hypercapnia 56.46 31.20 22 17062 830 3367945
Drug ineffective for unapproved indication 56.39 31.20 34 17050 3386 3365389
Conversion disorder 55.48 31.20 19 17065 493 3368282
Product packaging quantity issue 55.34 31.20 19 17065 497 3368278
Headache 55.12 31.20 173 16911 91807 3276968
Upper airway obstruction 53.26 31.20 15 17069 198 3368577
Encephalopathy 52.28 31.20 44 17040 7418 3361357
Brain death 52.17 31.20 21 17063 864 3367911
Disease progression 51.09 31.20 89 16995 32170 3336605
Allodynia 51.09 31.20 14 17070 166 3368609
Irritability 51.09 31.20 52 17032 11164 3357611
Application site erosion 51.01 31.20 14 17070 167 3368608
Product packaging issue 50.89 31.20 17 17067 408 3368367
Infusion site mass 50.39 31.20 13 17071 120 3368655
Drug dispensing error 49.79 31.20 33 17051 3875 3364900
Compartment syndrome 49.45 31.20 20 17064 833 3367942
Metastatic neoplasm 49.10 31.20 22 17062 1183 3367592
Procedural hypotension 48.66 31.20 16 17068 365 3368410
Aspartate aminotransferase increased 48.35 31.20 69 17015 21044 3347731
Ventricular extrasystoles 48.22 31.20 31 17053 3456 3365319
Lung cancer metastatic 47.70 31.20 20 17064 914 3367861
Amnesia 47.53 31.20 49 17035 10677 3358098
Vasoplegia syndrome 46.78 31.20 13 17071 163 3368612
Drug withdrawal syndrome neonatal 46.75 31.20 26 17058 2224 3366551
Incorrect drug administration rate 46.10 31.20 17 17067 550 3368225
Acute respiratory distress syndrome 45.99 31.20 37 17047 5857 3362918
Neuroleptic malignant syndrome 45.97 31.20 33 17051 4408 3364367
Pupil fixed 45.34 31.20 18 17066 714 3368061
Cancer pain 45.24 31.20 16 17068 458 3368317
Presbyacusis 45.11 31.20 10 17074 44 3368731
Hypoaesthesia 45.07 31.20 73 17011 24866 3343909
Blood creatine phosphokinase increased 44.71 31.20 52 17032 12961 3355814
Acute kidney injury 44.17 31.20 108 16976 49575 3319200
Arteriosclerosis 44.05 31.20 28 17056 3062 3365713
Secondary adrenocortical insufficiency 44.03 31.20 13 17071 205 3368570
General physical health deterioration 43.82 31.20 65 17019 20524 3348251
Aggression 43.37 31.20 48 17036 11337 3357438
Stridor 43.29 31.20 19 17065 972 3367803
Tooth fracture 43.18 31.20 23 17061 1806 3366969
Wheezing 43.01 31.20 41 17043 8130 3360645
Hepatic congestion 42.36 31.20 16 17068 554 3368221
Product use in unapproved indication 41.60 31.20 29 17055 3697 3365078
Acute postoperative sialadenitis 41.60 31.20 7 17077 2 3368773
Rash 41.28 31.20 132 16952 70689 3298086
Increased bronchial secretion 40.85 31.20 14 17070 364 3368411
Arteriosclerosis coronary artery 40.69 31.20 26 17058 2868 3365907
Accident 40.59 31.20 20 17064 1334 3367441
Blood pressure systolic decreased 40.12 31.20 19 17065 1161 3367614
Urticaria 40.05 31.20 75 17009 28652 3340123
Acute chest syndrome 40.02 31.20 11 17073 132 3368643
Suspected counterfeit product 40.02 31.20 12 17072 200 3368575
Balance disorder 39.91 31.20 48 17036 12391 3356384
Screaming 39.65 31.20 18 17066 998 3367777
Euphoric mood 39.62 31.20 21 17063 1633 3367142
Tryptase increased 39.60 31.20 10 17074 84 3368691
Analgesic drug level increased 39.42 31.20 12 17072 211 3368564
Anaesthetic complication cardiac 39.27 31.20 8 17076 21 3368754
Nystagmus 39.10 31.20 22 17062 1925 3366850
Cold sweat 39.04 31.20 26 17058 3077 3365698
Dystonia 39.01 31.20 28 17056 3739 3365036
Decorticate posture 39.00 31.20 8 17076 22 3368753
Feeling cold 38.26 31.20 28 17056 3852 3364923
Application site perspiration 38.03 31.20 7 17077 8 3368767
Blood albumin decreased 37.27 31.20 25 17059 2993 3365782
Alanine aminotransferase increased 37.13 31.20 65 17019 23575 3345200
Respiratory rate increased 37.07 31.20 23 17061 2410 3366365
Metabolic acidosis 36.92 31.20 39 17045 8739 3360036
Myotonia 36.60 31.20 9 17075 67 3368708
Renal impairment 36.51 31.20 56 17028 18205 3350570
Drug level increased 36.46 31.20 29 17055 4516 3364259
Somatic symptom disorder 36.40 31.20 13 17071 383 3368392
Chest pain 36.27 31.20 88 16996 40187 3328588
Product physical issue 36.25 31.20 18 17066 1221 3367554
Bedridden 36.09 31.20 20 17064 1699 3367076
Neuralgia 35.67 31.20 25 17059 3214 3365561
Speech disorder 35.64 31.20 39 17045 9093 3359682
Musculoskeletal stiffness 35.54 31.20 48 17036 13902 3354873
Myocardial infarction 35.11 31.20 92 16992 44041 3324734
Feeling jittery 35.08 31.20 22 17062 2349 3366426
Suicidal ideation 34.98 31.20 54 17030 17651 3351124
Breast cancer metastatic 34.89 31.20 20 17064 1813 3366962
Unevaluable event 34.86 31.20 46 17038 13030 3355745
Acidosis 34.80 31.20 23 17061 2687 3366088
Metastases to bone 34.59 31.20 24 17060 3037 3365738
Toxicologic test abnormal 34.35 31.20 11 17073 230 3368545
Deafness neurosensory 34.28 31.20 16 17068 946 3367829
Spinal anaesthesia 34.19 31.20 7 17077 19 3368756
Refusal of treatment by patient 34.11 31.20 21 17063 2171 3366604
Disturbance in attention 33.91 31.20 36 17048 8112 3360663
Nervous system disorder 33.86 31.20 29 17055 5004 3363771
Erythema 33.85 31.20 70 17014 28740 3340035
Application site discolouration 33.84 31.20 12 17072 346 3368429
Hyperkalaemia 33.67 31.20 42 17042 11252 3357523
Blood pressure systolic increased 33.63 31.20 24 17060 3175 3365600
Hypothermia 33.52 31.20 24 17060 3191 3365584
Device adhesion issue 33.46 31.20 9 17075 99 3368676
Supraventricular tachycardia 33.25 31.20 24 17060 3232 3365543
Poisoning deliberate 33.22 31.20 16 17068 1015 3367760
Cognitive disorder 33.14 31.20 35 17049 7839 3360936
Hypersensitivity 33.02 31.20 68 17016 27832 3340943
Uterine hypertonus 32.96 31.20 8 17076 56 3368719
Paraplegia 32.93 31.20 15 17069 838 3367937
Gait disturbance 32.87 31.20 68 17016 27924 3340851
Drug effect prolonged 32.84 31.20 10 17074 176 3368599
Medical device site pain 32.71 31.20 8 17076 58 3368717
Hallucination, visual 32.61 31.20 27 17057 4449 3364326
Blood pressure diastolic decreased 32.48 31.20 18 17066 1529 3367246
Incoherent 32.47 31.20 18 17066 1530 3367245
Expired product administered 32.38 31.20 19 17065 1800 3366975
Nervousness 32.32 31.20 31 17053 6193 3362582
Maternal drugs affecting foetus 32.27 31.20 25 17059 3746 3365029
Ventricular hypokinesia 32.17 31.20 16 17068 1089 3367686
Stupor 31.88 31.20 16 17068 1110 3367665
Anaesthetic complication neurological 31.60 31.20 9 17075 124 3368651
Troponin increased 31.58 31.20 19 17065 1884 3366891
Electrocardiogram ST segment depression 31.36 31.20 15 17069 937 3367838
Psychomotor hyperactivity 31.30 31.20 23 17061 3184 3365591

Pharmacologic Action:

SourceCodeDescription
ATC N01AH01 NERVOUS SYSTEM
ANESTHETICS
ANESTHETICS, GENERAL
Opioid anesthetics
ATC N01AH51 NERVOUS SYSTEM
ANESTHETICS
ANESTHETICS, GENERAL
Opioid anesthetics
ATC N02AB03 NERVOUS SYSTEM
ANALGESICS
OPIOIDS
Phenylpiperidine derivatives
FDA MoA N0000175684 Full Opioid Agonists
FDA EPC N0000175690 Opioid Agonist
MeSH PA D000759 Adjuvants, Anesthesia
MeSH PA D000700 Analgesics
MeSH PA D000701 Analgesics, Opioid
MeSH PA D000777 Anesthetics
MeSH PA D018681 Anesthetics, General
MeSH PA D018686 Anesthetics, Intravenous
CHEBI has role CHEBI:38877 intravenous anaesthetic
CHEBI has role CHEBI:38867 anaesthetic
CHEBI has role CHEBI:60809 adjuvant
CHEBI has role CHEBI:60807 anaesthesia adjuvant
CHEBI has role CHEBI:35482 opioid analgesic
CHEBI has role CHEBI:55322 mu-opioid receptor agonist
MeSH PA D002491 Central Nervous System Agents
MeSH PA D002492 Central Nervous System Depressants
MeSH PA D009294 Narcotics
MeSH PA D018373 Peripheral Nervous System Agents
MeSH PA D018689 Sensory System Agents

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Pain indication 22253000
General anesthesia indication 50697003
Local anesthesia indication 386761002
Acute postoperative pain indication 107401000119105
Breakthrough Pain in Opioid Tolerant Patients indication
Chronic Pain with Opioid Tolerance indication
Regional Anesthesia for Surgery indication
Regional Anesthesia for Postoperative Pain indication
Anesthesia for cesarean section off-label use 4847005
Severe pain off-label use 76948002
Conscious sedation off-label use 314271007
Sedation in Intubated Patients off-label use
Regional Anesthesia for Labor Pain off-label use
Alcoholism contraindication 7200002
Cardiomegaly contraindication 8186001
Chronic obstructive lung disease contraindication 13645005 DOID:3083
Asthenia contraindication 13791008
Neuroleptic malignant syndrome contraindication 15244003 DOID:14464
Chronic disease of respiratory system contraindication 17097001
Inflammatory bowel disease contraindication 24526004 DOID:0050589
Complete atrioventricular block contraindication 27885002
Shock contraindication 27942005
Hypovolemia contraindication 28560003
Orthostatic hypotension contraindication 28651003
Torsades de pointes contraindication 31722008
Dehydration contraindication 34095006
Depressive disorder contraindication 35489007 DOID:2848
Migraine contraindication 37796009 DOID:6364
Hypertensive disorder contraindication 38341003 DOID:10763
Hypokalemia contraindication 43339004
Decreased cardiac function contraindication 43650005
Low blood pressure contraindication 45007003
Chronic heart failure contraindication 48447003
Bradycardia contraindication 48867003
Disorder of cardiovascular system contraindication 49601007 DOID:1287
Paralytic ileus contraindication 55525008 DOID:8442
Hepatic failure contraindication 59927004
Drug AND/OR toxin-induced diarrhea contraindication 65979008
Substance abuse contraindication 66214007
Benign intracranial hypertension contraindication 68267002 DOID:11459
Extrapyramidal disease contraindication 76349003
Urethral stricture contraindication 76618002
Decreased respiratory function contraindication 80954004
Injury of head contraindication 82271004
Cor pulmonale contraindication 83291003 DOID:8515
Kidney disease contraindication 90708001 DOID:2527
Myasthenia gravis contraindication 91637004 DOID:437
Disorder of biliary tract contraindication 105997008 DOID:9741
Prolonged QT interval contraindication 111975006
Procedure on urinary system contraindication 118677009
Hypomagnesemia contraindication 190855004
Asthma contraindication 195967001 DOID:2841
Acute pancreatitis contraindication 197456007 DOID:2913
Headache disorder contraindication 230461009
Disease of liver contraindication 235856003 DOID:409
Sepsis syndrome contraindication 238150007
Benign prostatic hyperplasia contraindication 266569009 DOID:2883
Retention of urine contraindication 267064002
Lesion of brain contraindication 301766008
Pheochromocytoma contraindication 302835009
Deficiency of cholinesterase contraindication 360607009
Central nervous system depression contraindication 418072004
Congenital long QT syndrome contraindication 442917000
Acute exacerbation of asthma contraindication 708038006
Pain in Opioid Naive Patients contraindication
Headache Pain especially in Patients who are not Opiate Tolerant contraindication
Refractory Extrinsic Asthma contraindication

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 8.62 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
EQ 40MCG BASE/ACTIVATION IONSYS THE MEDICINES CO N021338 May 22, 2006 RX SYSTEM IONTOPHORESIS, TRANSDERMAL 6169920 Jan. 2, 2018 METHOD FOR IONTOPHORETIC TRANSDERMAL DELIVERY OF FENTANYL HYDROCHLORIDE
EQ 0.1MG BASE LAZANDA ELEFSEE PHARMS INTL N022569 June 30, 2011 RX SPRAY, METERED NASAL 6432440 April 20, 2018 MANAGEMENT OF BREAKTHROUGH PAIN IN CANCER PATIENTS 18 YEARS OF AGE AND OLDER WHO ARE RECEIVING AND TOLERANT TO OPIOID THERAPY FOR THEIR UNDERLYING PERSISTENT CANCER PAIN
EQ 0.4MG BASE LAZANDA ELEFSEE PHARMS INTL N022569 June 30, 2011 RX SPRAY, METERED NASAL 6432440 April 20, 2018 MANAGEMENT OF BREAKTHROUGH PAIN IN CANCER PATIENTS 18 YEARS OF AGE AND OLDER WHO ARE RECEIVING AND TOLERANT TO OPIOID THERAPY FOR THEIR UNDERLYING PERSISTENT CANCER PAIN
EQ 40MCG BASE/ACTIVATION IONSYS THE MEDICINES CO N021338 May 22, 2006 RX SYSTEM IONTOPHORESIS, TRANSDERMAL 6195582 Jan. 28, 2019 METHOD FOR IONTOPHORETIC TRANSDERMAL DELIVERY OF FENTANYL HYDROCHLORIDE
EQ 0.1MG BASE FENTORA CEPHALON N021947 Sept. 25, 2006 RX TABLET BUCCAL, SUBLINGUAL 6200604 March 26, 2019 MANAGEMENT OF BREAKTHROUGH PAIN IN PATIENTS WITH CANCER
EQ 0.1MG BASE FENTORA CEPHALON N021947 Sept. 25, 2006 RX TABLET BUCCAL, SUBLINGUAL 6974590 March 26, 2019 MANAGEMENT OF BREAKTHROUGH PAIN IN PATIENTS WITH CANCER
EQ 0.1MG BASE FENTORA CEPHALON N021947 Sept. 25, 2006 RX TABLET BUCCAL, SUBLINGUAL 8728441 March 26, 2019 MANAGEMENT OF BREAKTHROUGH PAIN IN PATIENTS WITH CANCER BY BUCCAL OR SUBLINGUAL ADMINISTRATION OF FENTANYL
EQ 0.1MG BASE FENTORA CEPHALON N021947 Sept. 25, 2006 RX TABLET BUCCAL, SUBLINGUAL 8753611 March 26, 2019 MANAGEMENT OF BREAKTHROUGH PAIN IN PATIENTS WITH CANCER BY BUCCAL OR SUBLINGUAL ADMINISTRATION OF FENTANYL
EQ 0.2MG BASE FENTORA CEPHALON N021947 Sept. 25, 2006 RX TABLET BUCCAL, SUBLINGUAL 6200604 March 26, 2019 MANAGEMENT OF BREAKTHROUGH PAIN IN PATIENTS WITH CANCER
EQ 0.2MG BASE FENTORA CEPHALON N021947 Sept. 25, 2006 RX TABLET BUCCAL, SUBLINGUAL 6974590 March 26, 2019 MANAGEMENT OF BREAKTHROUGH PAIN IN PATIENTS WITH CANCER
EQ 0.2MG BASE FENTORA CEPHALON N021947 Sept. 25, 2006 RX TABLET BUCCAL, SUBLINGUAL 8728441 March 26, 2019 MANAGEMENT OF BREAKTHROUGH PAIN IN PATIENTS WITH CANCER BY BUCCAL OR SUBLINGUAL ADMINISTRATION OF FENTANYL
EQ 0.2MG BASE FENTORA CEPHALON N021947 Sept. 25, 2006 RX TABLET BUCCAL, SUBLINGUAL 8753611 March 26, 2019 MANAGEMENT OF BREAKTHROUGH PAIN IN PATIENTS WITH CANCER BY BUCCAL OR SUBLINGUAL ADMINISTRATION OF FENTANYL
EQ 0.3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** FENTORA CEPHALON N021947 March 2, 2007 DISCN TABLET BUCCAL, SUBLINGUAL 6200604 March 26, 2019 MANAGEMENT OF BREAKTHROUGH PAIN IN PATIENTS WITH CANCER
EQ 0.3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** FENTORA CEPHALON N021947 March 2, 2007 DISCN TABLET BUCCAL, SUBLINGUAL 6974590 March 26, 2019 MANAGEMENT OF BREAKTHROUGH PAIN IN PATIENTS WITH CANCER
EQ 0.4MG BASE FENTORA CEPHALON N021947 Sept. 25, 2006 RX TABLET BUCCAL, SUBLINGUAL 6200604 March 26, 2019 MANAGEMENT OF BREAKTHROUGH PAIN IN PATIENTS WITH CANCER
EQ 0.4MG BASE FENTORA CEPHALON N021947 Sept. 25, 2006 RX TABLET BUCCAL, SUBLINGUAL 6974590 March 26, 2019 MANAGEMENT OF BREAKTHROUGH PAIN IN PATIENTS WITH CANCER
EQ 0.4MG BASE FENTORA CEPHALON N021947 Sept. 25, 2006 RX TABLET BUCCAL, SUBLINGUAL 8728441 March 26, 2019 MANAGEMENT OF BREAKTHROUGH PAIN IN PATIENTS WITH CANCER BY BUCCAL OR SUBLINGUAL ADMINISTRATION OF FENTANYL
EQ 0.4MG BASE FENTORA CEPHALON N021947 Sept. 25, 2006 RX TABLET BUCCAL, SUBLINGUAL 8753611 March 26, 2019 MANAGEMENT OF BREAKTHROUGH PAIN IN PATIENTS WITH CANCER BY BUCCAL OR SUBLINGUAL ADMINISTRATION OF FENTANYL
EQ 0.6MG BASE FENTORA CEPHALON N021947 Sept. 25, 2006 RX TABLET BUCCAL, SUBLINGUAL 6200604 March 26, 2019 MANAGEMENT OF BREAKTHROUGH PAIN IN PATIENTS WITH CANCER
EQ 0.6MG BASE FENTORA CEPHALON N021947 Sept. 25, 2006 RX TABLET BUCCAL, SUBLINGUAL 6974590 March 26, 2019 MANAGEMENT OF BREAKTHROUGH PAIN IN PATIENTS WITH CANCER
EQ 0.6MG BASE FENTORA CEPHALON N021947 Sept. 25, 2006 RX TABLET BUCCAL, SUBLINGUAL 8728441 March 26, 2019 MANAGEMENT OF BREAKTHROUGH PAIN IN PATIENTS WITH CANCER BY BUCCAL OR SUBLINGUAL ADMINISTRATION OF FENTANYL
EQ 0.6MG BASE FENTORA CEPHALON N021947 Sept. 25, 2006 RX TABLET BUCCAL, SUBLINGUAL 8753611 March 26, 2019 MANAGEMENT OF BREAKTHROUGH PAIN IN PATIENTS WITH CANCER BY BUCCAL OR SUBLINGUAL ADMINISTRATION OF FENTANYL
EQ 0.8MG BASE FENTORA CEPHALON N021947 Sept. 25, 2006 RX TABLET BUCCAL, SUBLINGUAL 6200604 March 26, 2019 MANAGEMENT OF BREAKTHROUGH PAIN IN PATIENTS WITH CANCER
EQ 0.8MG BASE FENTORA CEPHALON N021947 Sept. 25, 2006 RX TABLET BUCCAL, SUBLINGUAL 6974590 March 26, 2019 MANAGEMENT OF BREAKTHROUGH PAIN IN PATIENTS WITH CANCER
EQ 0.8MG BASE FENTORA CEPHALON N021947 Sept. 25, 2006 RX TABLET BUCCAL, SUBLINGUAL 8728441 March 26, 2019 MANAGEMENT OF BREAKTHROUGH PAIN IN PATIENTS WITH CANCER BY BUCCAL OR SUBLINGUAL ADMINISTRATION OF FENTANYL
EQ 0.8MG BASE FENTORA CEPHALON N021947 Sept. 25, 2006 RX TABLET BUCCAL, SUBLINGUAL 8753611 March 26, 2019 MANAGEMENT OF BREAKTHROUGH PAIN IN PATIENTS WITH CANCER BY BUCCAL OR SUBLINGUAL ADMINISTRATION OF FENTANYL
EQ 0.1MG BASE ABSTRAL SENTYNL THERAPS INC N022510 Jan. 7, 2011 RX TABLET SUBLINGUAL 6759059 Sept. 24, 2019 MANAGEMENT OF BREAKTHROUGH PAIN IN PATIENTS WITH CANCER
EQ 0.1MG BASE ABSTRAL SENTYNL THERAPS INC N022510 Jan. 7, 2011 RX TABLET SUBLINGUAL 6761910 Sept. 24, 2019 MANAGEMENT OF BREAKTHROUGH PAIN IN PATIENTS WITH CANCER
EQ 0.1MG BASE ABSTRAL SENTYNL THERAPS INC N022510 Jan. 7, 2011 RX TABLET SUBLINGUAL 7910132 Sept. 24, 2019 MANAGEMENT OF BREAKTHROUGH PAIN IN PATIENTS WITH CANCER
EQ 0.2MG BASE ABSTRAL SENTYNL THERAPS INC N022510 Jan. 7, 2011 RX TABLET SUBLINGUAL 6759059 Sept. 24, 2019 MANAGEMENT OF BREAKTHROUGH PAIN IN PATIENTS WITH CANCER
EQ 0.2MG BASE ABSTRAL SENTYNL THERAPS INC N022510 Jan. 7, 2011 RX TABLET SUBLINGUAL 6761910 Sept. 24, 2019 MANAGEMENT OF BREAKTHROUGH PAIN IN PATIENTS WITH CANCER
EQ 0.2MG BASE ABSTRAL SENTYNL THERAPS INC N022510 Jan. 7, 2011 RX TABLET SUBLINGUAL 7910132 Sept. 24, 2019 MANAGEMENT OF BREAKTHROUGH PAIN IN PATIENTS WITH CANCER
EQ 0.3MG BASE ABSTRAL SENTYNL THERAPS INC N022510 Jan. 7, 2011 RX TABLET SUBLINGUAL 6759059 Sept. 24, 2019 MANAGEMENT OF BREAKTHROUGH PAIN IN PATIENTS WITH CANCER
EQ 0.3MG BASE ABSTRAL SENTYNL THERAPS INC N022510 Jan. 7, 2011 RX TABLET SUBLINGUAL 6761910 Sept. 24, 2019 MANAGEMENT OF BREAKTHROUGH PAIN IN PATIENTS WITH CANCER
EQ 0.3MG BASE ABSTRAL SENTYNL THERAPS INC N022510 Jan. 7, 2011 RX TABLET SUBLINGUAL 7910132 Sept. 24, 2019 MANAGEMENT OF BREAKTHROUGH PAIN IN PATIENTS WITH CANCER
EQ 0.4MG BASE ABSTRAL SENTYNL THERAPS INC N022510 Jan. 7, 2011 RX TABLET SUBLINGUAL 6759059 Sept. 24, 2019 MANAGEMENT OF BREAKTHROUGH PAIN IN PATIENTS WITH CANCER
EQ 0.4MG BASE ABSTRAL SENTYNL THERAPS INC N022510 Jan. 7, 2011 RX TABLET SUBLINGUAL 6761910 Sept. 24, 2019 MANAGEMENT OF BREAKTHROUGH PAIN IN PATIENTS WITH CANCER
EQ 0.4MG BASE ABSTRAL SENTYNL THERAPS INC N022510 Jan. 7, 2011 RX TABLET SUBLINGUAL 7910132 Sept. 24, 2019 MANAGEMENT OF BREAKTHROUGH PAIN IN PATIENTS WITH CANCER
EQ 0.6MG BASE ABSTRAL SENTYNL THERAPS INC N022510 Jan. 7, 2011 RX TABLET SUBLINGUAL 6759059 Sept. 24, 2019 MANAGEMENT OF BREAKTHROUGH PAIN IN PATIENTS WITH CANCER
EQ 0.6MG BASE ABSTRAL SENTYNL THERAPS INC N022510 Jan. 7, 2011 RX TABLET SUBLINGUAL 6761910 Sept. 24, 2019 MANAGEMENT OF BREAKTHROUGH PAIN IN PATIENTS WITH CANCER
EQ 0.6MG BASE ABSTRAL SENTYNL THERAPS INC N022510 Jan. 7, 2011 RX TABLET SUBLINGUAL 7910132 Sept. 24, 2019 MANAGEMENT OF BREAKTHROUGH PAIN IN PATIENTS WITH CANCER
EQ 0.8MG BASE ABSTRAL SENTYNL THERAPS INC N022510 Jan. 7, 2011 RX TABLET SUBLINGUAL 6759059 Sept. 24, 2019 MANAGEMENT OF BREAKTHROUGH PAIN IN PATIENTS WITH CANCER
EQ 0.8MG BASE ABSTRAL SENTYNL THERAPS INC N022510 Jan. 7, 2011 RX TABLET SUBLINGUAL 6761910 Sept. 24, 2019 MANAGEMENT OF BREAKTHROUGH PAIN IN PATIENTS WITH CANCER
EQ 0.8MG BASE ABSTRAL SENTYNL THERAPS INC N022510 Jan. 7, 2011 RX TABLET SUBLINGUAL 7910132 Sept. 24, 2019 MANAGEMENT OF BREAKTHROUGH PAIN IN PATIENTS WITH CANCER
EQ 0.2MG BASE ONSOLIS BDSI N022266 July 16, 2009 DISCN FILM BUCCAL 7579019 Jan. 22, 2020 MANAGEMENT OF BREAKTHROUGH PAIN IN PATIENTS WITH CANCER
EQ 0.4MG BASE ONSOLIS BDSI N022266 July 16, 2009 DISCN FILM BUCCAL 7579019 Jan. 22, 2020 MANAGEMENT OF BREAKTHROUGH PAIN IN PATIENTS WITH CANCER
EQ 0.6MG BASE ONSOLIS BDSI N022266 July 16, 2009 DISCN FILM BUCCAL 7579019 Jan. 22, 2020 MANAGEMENT OF BREAKTHROUGH PAIN IN PATIENTS WITH CANCER
EQ 0.8MG BASE ONSOLIS BDSI N022266 July 16, 2009 DISCN FILM BUCCAL 7579019 Jan. 22, 2020 MANAGEMENT OF BREAKTHROUGH PAIN IN PATIENTS WITH CANCER
EQ 1.2MG BASE ONSOLIS BDSI N022266 July 16, 2009 DISCN FILM BUCCAL 7579019 Jan. 22, 2020 MANAGEMENT OF BREAKTHROUGH PAIN IN PATIENTS WITH CANCER
EQ 40MCG BASE/ACTIVATION IONSYS THE MEDICINES CO N021338 May 22, 2006 RX SYSTEM IONTOPHORESIS, TRANSDERMAL 6881208 April 19, 2022 METHOD FOR IONTOPHORETIC TRANSDERMAL DELIVERY OF FENTANYL HYDROCHLORIDE
EQ 0.1MG BASE LAZANDA ELEFSEE PHARMS INTL N022569 June 30, 2011 RX SPRAY, METERED NASAL 8889176 Jan. 16, 2024 MANAGEMENT OF BREAKTHROUGH PAIN IN PATIENTS WITH CANCER
EQ 0.4MG BASE LAZANDA ELEFSEE PHARMS INTL N022569 June 30, 2011 RX SPRAY, METERED NASAL 8889176 Jan. 16, 2024 MANAGEMENT OF BREAKTHROUGH PAIN IN PATIENTS WITH CANCER
EQ 0.1MG BASE LAZANDA ELEFSEE PHARMS INTL N022569 June 30, 2011 RX SPRAY, METERED NASAL 8216604 Oct. 3, 2024 MANAGEMENT OF BREAKTHROUGH PAIN IN PATIENTS WITH CANCER
EQ 0.4MG BASE LAZANDA ELEFSEE PHARMS INTL N022569 June 30, 2011 RX SPRAY, METERED NASAL 8216604 Oct. 3, 2024 MANAGEMENT OF BREAKTHROUGH PAIN IN PATIENTS WITH CANCER
0.1MG SUBSYS INSYS DEV CO INC N202788 Jan. 4, 2012 RX SPRAY SUBLINGUAL 8835460 Jan. 25, 2027 TREATMENT OF PAIN
0.1MG SUBSYS INSYS DEV CO INC N202788 Jan. 4, 2012 RX SPRAY SUBLINGUAL 9289387 Jan. 25, 2027 TREATMENT OF PAIN
0.1MG SUBSYS INSYS DEV CO INC N202788 Jan. 4, 2012 RX SPRAY SUBLINGUAL 9642797 Jan. 25, 2027 TREATMENT OF PAIN
0.2MG SUBSYS INSYS DEV CO INC N202788 Jan. 4, 2012 RX SPRAY SUBLINGUAL 8835460 Jan. 25, 2027 TREATMENT OF PAIN
0.2MG SUBSYS INSYS DEV CO INC N202788 Jan. 4, 2012 RX SPRAY SUBLINGUAL 9289387 Jan. 25, 2027 TREATMENT OF PAIN
0.2MG SUBSYS INSYS DEV CO INC N202788 Jan. 4, 2012 RX SPRAY SUBLINGUAL 9642797 Jan. 25, 2027 TREATMENT OF PAIN
0.4MG SUBSYS INSYS DEV CO INC N202788 Jan. 4, 2012 RX SPRAY SUBLINGUAL 8835460 Jan. 25, 2027 TREATMENT OF PAIN
0.4MG SUBSYS INSYS DEV CO INC N202788 Jan. 4, 2012 RX SPRAY SUBLINGUAL 9289387 Jan. 25, 2027 TREATMENT OF PAIN
0.4MG SUBSYS INSYS DEV CO INC N202788 Jan. 4, 2012 RX SPRAY SUBLINGUAL 9642797 Jan. 25, 2027 TREATMENT OF PAIN
0.6MG SUBSYS INSYS DEV CO INC N202788 Jan. 4, 2012 RX SPRAY SUBLINGUAL 8835460 Jan. 25, 2027 TREATMENT OF PAIN
0.6MG SUBSYS INSYS DEV CO INC N202788 Jan. 4, 2012 RX SPRAY SUBLINGUAL 9289387 Jan. 25, 2027 TREATMENT OF PAIN
0.6MG SUBSYS INSYS DEV CO INC N202788 Jan. 4, 2012 RX SPRAY SUBLINGUAL 9642797 Jan. 25, 2027 TREATMENT OF PAIN
0.8MG SUBSYS INSYS DEV CO INC N202788 Jan. 4, 2012 RX SPRAY SUBLINGUAL 8835460 Jan. 25, 2027 TREATMENT OF PAIN
0.8MG SUBSYS INSYS DEV CO INC N202788 Jan. 4, 2012 RX SPRAY SUBLINGUAL 9289387 Jan. 25, 2027 TREATMENT OF PAIN
0.8MG SUBSYS INSYS DEV CO INC N202788 Jan. 4, 2012 RX SPRAY SUBLINGUAL 9642797 Jan. 25, 2027 TREATMENT OF PAIN
1.2MG SUBSYS INSYS DEV CO INC N202788 Aug. 30, 2012 RX SPRAY SUBLINGUAL 8835460 Jan. 25, 2027 TREATMENT OF PAIN
1.2MG SUBSYS INSYS DEV CO INC N202788 Aug. 30, 2012 RX SPRAY SUBLINGUAL 9289387 Jan. 25, 2027 TREATMENT OF PAIN
1.2MG SUBSYS INSYS DEV CO INC N202788 Aug. 30, 2012 RX SPRAY SUBLINGUAL 9642797 Jan. 25, 2027 TREATMENT OF PAIN
1.6MG SUBSYS INSYS DEV CO INC N202788 Aug. 30, 2012 RX SPRAY SUBLINGUAL 8835460 Jan. 25, 2027 TREATMENT OF PAIN
1.6MG SUBSYS INSYS DEV CO INC N202788 Aug. 30, 2012 RX SPRAY SUBLINGUAL 9289387 Jan. 25, 2027 TREATMENT OF PAIN
1.6MG SUBSYS INSYS DEV CO INC N202788 Aug. 30, 2012 RX SPRAY SUBLINGUAL 9642797 Jan. 25, 2027 TREATMENT OF PAIN
EQ 0.2MG BASE ONSOLIS BDSI N022266 July 16, 2009 DISCN FILM BUCCAL 9597288 July 23, 2027 MANAGEMENT OF BREAKTHROUGH PAIN IN PATIENTS WITH CANCER
EQ 0.4MG BASE ONSOLIS BDSI N022266 July 16, 2009 DISCN FILM BUCCAL 9597288 July 23, 2027 MANAGEMENT OF BREAKTHROUGH PAIN IN PATIENTS WITH CANCER
EQ 0.6MG BASE ONSOLIS BDSI N022266 July 16, 2009 DISCN FILM BUCCAL 9597288 July 23, 2027 MANAGEMENT OF BREAKTHROUGH PAIN IN PATIENTS WITH CANCER
EQ 0.8MG BASE ONSOLIS BDSI N022266 July 16, 2009 DISCN FILM BUCCAL 9597288 July 23, 2027 MANAGEMENT OF BREAKTHROUGH PAIN IN PATIENTS WITH CANCER
EQ 1.2MG BASE ONSOLIS BDSI N022266 July 16, 2009 DISCN FILM BUCCAL 9597288 July 23, 2027 MANAGEMENT OF BREAKTHROUGH PAIN IN PATIENTS WITH CANCER
0.1MG SUBSYS INSYS DEV CO INC N202788 Jan. 4, 2012 RX SPRAY SUBLINGUAL 8486973 April 27, 2030 TREATMENT OF PAIN
0.2MG SUBSYS INSYS DEV CO INC N202788 Jan. 4, 2012 RX SPRAY SUBLINGUAL 8486973 April 27, 2030 TREATMENT OF PAIN
0.4MG SUBSYS INSYS DEV CO INC N202788 Jan. 4, 2012 RX SPRAY SUBLINGUAL 8486973 April 27, 2030 TREATMENT OF PAIN
0.6MG SUBSYS INSYS DEV CO INC N202788 Jan. 4, 2012 RX SPRAY SUBLINGUAL 8486973 April 27, 2030 TREATMENT OF PAIN
0.8MG SUBSYS INSYS DEV CO INC N202788 Jan. 4, 2012 RX SPRAY SUBLINGUAL 8486973 April 27, 2030 TREATMENT OF PAIN
1.2MG SUBSYS INSYS DEV CO INC N202788 Aug. 30, 2012 RX SPRAY SUBLINGUAL 8486973 April 27, 2030 TREATMENT OF PAIN
1.6MG SUBSYS INSYS DEV CO INC N202788 Aug. 30, 2012 RX SPRAY SUBLINGUAL 8486973 April 27, 2030 TREATMENT OF PAIN
EQ 40MCG BASE/ACTIVATION IONSYS THE MEDICINES CO N021338 May 22, 2006 RX SYSTEM IONTOPHORESIS, TRANSDERMAL 9364656 Sept. 30, 2031 METHOD FOR IONTOPHORETIC TRANSDERMAL DELIVERY OF FENTANYL HYDROCHLORIDE
EQ 40MCG BASE/ACTIVATION IONSYS THE MEDICINES CO N021338 May 22, 2006 RX SYSTEM IONTOPHORESIS, TRANSDERMAL 8781571 March 31, 2032 METHOD FOR IONTOPHORETIC TRANSDERMAL DELIVERY OF FENTANYL HYDROCHLORIDE
EQ 40MCG BASE/ACTIVATION IONSYS THE MEDICINES CO N021338 May 22, 2006 RX SYSTEM IONTOPHORESIS, TRANSDERMAL 8428708 May 21, 2032 METHOD FOR IONTOPHORETIC TRANSDERMAL DELIVERY OF FENTANYL HYDROCHLORIDE
EQ 40MCG BASE/ACTIVATION IONSYS THE MEDICINES CO N021338 May 22, 2006 RX SYSTEM IONTOPHORESIS, TRANSDERMAL 8428709 June 11, 2032 METHOD FOR IONTOPHORETIC TRANSDERMAL DELIVERY OF FENTANYL HYDROCHLORIDE

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Mu-type opioid receptor GPCR AGONIST EC50 9.00 WOMBAT-PK CHEMBL
Kappa-type opioid receptor GPCR Ki 6.71 CHEMBL
Delta-type opioid receptor GPCR Ki 6.17 CHEMBL
Potassium voltage-gated channel subfamily H member 2 Ion channel IC50 5.74 CHEMBL
Monoamine oxidase Enzyme Ki 5.26 CHEMBL
Kappa-type opioid receptor GPCR Ki 6.71 CHEMBL
Delta-type opioid receptor GPCR IC50 8.03 CHEMBL
Mu-type opioid receptor GPCR Ki 8.07 CHEMBL
Histamine H1 receptor GPCR IC50 4.70 CHEMBL
Opioid receptor GPCR Ki 8.67 CHEMBL
Delta-type opioid receptor GPCR Ki 6.40 CHEMBL
Mu-type opioid receptor GPCR Ki 8.82 CHEMBL
Mu-type opioid receptor GPCR Ki 8.23 CHEMBL

External reference:

IDSource
1626 IUPHAR_LIGAND_ID
4018745 VUID
N0000147049 NUI
C0015846 UMLSCUI
D00320 KEGG_DRUG
CHEMBL596 ChEMBL_ID
CHEMBL688 ChEMBL_ID
59H156XY46 UNII
1443-54-5 SECONDARY_CAS_RN
DB00813 DRUGBANK_ID
4337 RXNORM
373492002 SNOMEDCT_US
40648001 SNOMEDCT_US
4721 MMSL
4018745 VANDF
N0000147049 NDFRT
N0000007029 NDFRT
003571 NDDF
64408 MMSL
d00233 MMSL
3345 PUBCHEM_CID
CHEMBL1201159 ChEMBL_ID
D005283 MESH_DESCRIPTOR_UI
1608 INN_ID
CHEBI:119915 CHEBI
7V7 PDB_CHEM_ID

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Fentanyl Citrate HUMAN PRESCRIPTION DRUG LABEL 1 0093-7865 LOZENGE 200 ug ORAL NDA authorized generic 20 sections
Fentanyl Citrate HUMAN PRESCRIPTION DRUG LABEL 1 0093-7866 LOZENGE 400 ug ORAL NDA authorized generic 20 sections
Fentanyl Citrate HUMAN PRESCRIPTION DRUG LABEL 1 0093-7867 LOZENGE 600 ug ORAL NDA authorized generic 20 sections
Fentanyl Citrate HUMAN PRESCRIPTION DRUG LABEL 1 0093-7868 LOZENGE 800 ug ORAL NDA authorized generic 20 sections
Fentanyl Citrate HUMAN PRESCRIPTION DRUG LABEL 1 0093-7869 LOZENGE 1200 ug ORAL NDA authorized generic 20 sections
Fentanyl Citrate HUMAN PRESCRIPTION DRUG LABEL 1 0093-7870 LOZENGE 1600 ug ORAL NDA authorized generic 20 sections
FENTANYL HUMAN PRESCRIPTION DRUG LABEL 1 0378-9119 PATCH 12 ug TRANSDERMAL ANDA 20 sections
FENTANYL HUMAN PRESCRIPTION DRUG LABEL 1 0378-9121 PATCH 25 ug TRANSDERMAL ANDA 20 sections
FENTANYL HUMAN PRESCRIPTION DRUG LABEL 1 0378-9122 PATCH 50 ug TRANSDERMAL ANDA 20 sections
FENTANYL HUMAN PRESCRIPTION DRUG LABEL 1 0378-9123 PATCH 75 ug TRANSDERMAL ANDA 20 sections
FENTANYL HUMAN PRESCRIPTION DRUG LABEL 1 0378-9124 PATCH 100 ug TRANSDERMAL ANDA 20 sections
FENTANYL HUMAN PRESCRIPTION DRUG LABEL 1 0378-9125 PATCH 37.50 ug TRANSDERMAL ANDA 20 sections
FENTANYL HUMAN PRESCRIPTION DRUG LABEL 1 0378-9126 PATCH 62.50 ug TRANSDERMAL ANDA 20 sections
FENTANYL HUMAN PRESCRIPTION DRUG LABEL 1 0378-9127 PATCH 87.50 ug TRANSDERMAL ANDA 20 sections
FENTANYL TRANSDERMAL SYSTEM HUMAN PRESCRIPTION DRUG LABEL 1 0406-9000 PATCH, EXTENDED RELEASE 100 ug TRANSDERMAL ANDA 21 sections
FENTANYL TRANSDERMAL SYSTEM HUMAN PRESCRIPTION DRUG LABEL 1 0406-9012 PATCH, EXTENDED RELEASE 12.50 ug TRANSDERMAL ANDA 21 sections
FENTANYL TRANSDERMAL SYSTEM HUMAN PRESCRIPTION DRUG LABEL 1 0406-9025 PATCH, EXTENDED RELEASE 25 ug TRANSDERMAL ANDA 21 sections
FENTANYL TRANSDERMAL SYSTEM HUMAN PRESCRIPTION DRUG LABEL 1 0406-9050 PATCH, EXTENDED RELEASE 50 ug TRANSDERMAL ANDA 21 sections
FENTANYL TRANSDERMAL SYSTEM HUMAN PRESCRIPTION DRUG LABEL 1 0406-9075 PATCH, EXTENDED RELEASE 75 ug TRANSDERMAL ANDA 21 sections
FENTANYL CITRATE HUMAN PRESCRIPTION DRUG LABEL 1 0406-9202 LOZENGE 200 ug TRANSMUCOSAL ANDA 20 sections
FENTANYL CITRATE HUMAN PRESCRIPTION DRUG LABEL 1 0406-9204 LOZENGE 400 ug TRANSMUCOSAL ANDA 20 sections
FENTANYL CITRATE HUMAN PRESCRIPTION DRUG LABEL 1 0406-9206 LOZENGE 600 ug TRANSMUCOSAL ANDA 20 sections
FENTANYL CITRATE HUMAN PRESCRIPTION DRUG LABEL 1 0406-9208 LOZENGE 800 ug TRANSMUCOSAL ANDA 20 sections
FENTANYL CITRATE HUMAN PRESCRIPTION DRUG LABEL 1 0406-9212 LOZENGE 1200 ug TRANSMUCOSAL ANDA 20 sections
FENTANYL CITRATE HUMAN PRESCRIPTION DRUG LABEL 1 0406-9216 LOZENGE 1600 ug TRANSMUCOSAL ANDA 20 sections
Fentanyl Citrate HUMAN PRESCRIPTION DRUG LABEL 1 0409-1276 INJECTION, SOLUTION 50 ug INTRAMUSCULAR ANDA 18 sections
Fentanyl Citrate HUMAN PRESCRIPTION DRUG LABEL 1 0409-9093 INJECTION, SOLUTION 50 ug INTRAMUSCULAR NDA 19 sections
Fentanyl Citrate HUMAN PRESCRIPTION DRUG LABEL 1 0409-9094 INJECTION, SOLUTION 50 ug INTRAMUSCULAR NDA 19 sections
Fentanyl HUMAN PRESCRIPTION DRUG LABEL 1 0591-3198 PATCH, EXTENDED RELEASE 25 ug TRANSDERMAL ANDA 21 sections
Fentanyl HUMAN PRESCRIPTION DRUG LABEL 1 0591-3212 PATCH, EXTENDED RELEASE 50 ug TRANSDERMAL ANDA 21 sections