Stem definition | Drug id | CAS RN |
---|---|---|
opioid receptor antagonists/agonists, morphinan derivates | 434 | 52485-79-7 |
Dose | Unit | Route |
---|---|---|
1.20 | mg | P |
1.20 | mg | SL |
1.20 | mg | TD |
2.10 | mg | P |
8 | mg | SL |
8 | mg | SL |
Property | Value | Reference |
---|---|---|
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 ยตM/kg/day | Contrera JF, Matthews EJ, Kruhlak NL, Benz RD |
BA (Bioavailability) | 28 % | 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 |
Date | Agency | Company | Orphan |
---|---|---|---|
June 19, 2019 | EMA | L. Molteni & C. dei Fratelli Alitti Societร di Esercizio S.p.A. | |
Dec. 29, 1981 | FDA | RECKITT BENCKISER |
MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
---|---|---|---|---|---|---|
Application site pruritus | 1699.40 | 13.16 | 404 | 29773 | 3355 | 50571592 |
Product adhesion issue | 1682.47 | 13.16 | 413 | 29764 | 3979 | 50570968 |
Drug withdrawal syndrome | 1387.46 | 13.16 | 532 | 29645 | 24549 | 50550398 |
Application site erythema | 1187.80 | 13.16 | 315 | 29862 | 4223 | 50570724 |
Application site rash | 929.44 | 13.16 | 227 | 29950 | 2130 | 50572817 |
Inadequate analgesia | 719.17 | 13.16 | 188 | 29989 | 2370 | 50572577 |
Application site pain | 699.08 | 13.16 | 200 | 29977 | 3598 | 50571349 |
Application site vesicles | 697.96 | 13.16 | 162 | 30015 | 1193 | 50573754 |
Application site burn | 558.81 | 13.16 | 122 | 30055 | 654 | 50574293 |
Drug withdrawal syndrome neonatal | 458.76 | 13.16 | 123 | 30054 | 1718 | 50573229 |
Drug abuse | 421.16 | 13.16 | 321 | 29856 | 59525 | 50515422 |
Drug dependence | 398.70 | 13.16 | 207 | 29970 | 19552 | 50555395 |
Application site irritation | 360.77 | 13.16 | 99 | 30078 | 1516 | 50573431 |
Maternal exposure during pregnancy | 345.98 | 13.16 | 450 | 29727 | 159328 | 50415619 |
Foetal exposure during pregnancy | 242.80 | 13.16 | 169 | 30008 | 27190 | 50547757 |
Wrong technique in product usage process | 241.85 | 13.16 | 226 | 29951 | 55284 | 50519663 |
Application site scar | 233.35 | 13.16 | 48 | 30129 | 182 | 50574765 |
Exposure during pregnancy | 228.29 | 13.16 | 319 | 29858 | 120696 | 50454251 |
Application site discharge | 224.93 | 13.16 | 44 | 30133 | 120 | 50574827 |
Substance abuse | 211.64 | 13.16 | 83 | 30094 | 4041 | 50570906 |
Application site erosion | 201.33 | 13.16 | 41 | 30136 | 146 | 50574801 |
Application site exfoliation | 187.61 | 13.16 | 42 | 30135 | 257 | 50574690 |
Application site dryness | 181.42 | 13.16 | 37 | 30140 | 133 | 50574814 |
Application site discolouration | 167.61 | 13.16 | 46 | 30131 | 704 | 50574243 |
Premature delivery | 144.77 | 13.16 | 117 | 30060 | 23546 | 50551401 |
Withdrawal syndrome | 142.92 | 13.16 | 103 | 30074 | 17487 | 50557460 |
Application site urticaria | 138.48 | 13.16 | 32 | 30145 | 230 | 50574717 |
Product solubility abnormal | 122.25 | 13.16 | 36 | 30141 | 718 | 50574229 |
Abortion spontaneous | 121.67 | 13.16 | 137 | 30040 | 41635 | 50533312 |
Product physical issue | 118.90 | 13.16 | 56 | 30121 | 4276 | 50570671 |
Application site swelling | 113.40 | 13.16 | 31 | 30146 | 467 | 50574480 |
Application site reaction | 112.88 | 13.16 | 33 | 30144 | 641 | 50574306 |
Product packaging quantity issue | 109.51 | 13.16 | 36 | 30141 | 1044 | 50573903 |
Inappropriate schedule of product administration | 103.32 | 13.16 | 167 | 30010 | 71664 | 50503283 |
Product administered at inappropriate site | 100.66 | 13.16 | 42 | 30135 | 2401 | 50572546 |
Placental disorder | 95.89 | 13.16 | 35 | 30142 | 1395 | 50573552 |
Hyperhidrosis | 95.02 | 13.16 | 182 | 29995 | 89244 | 50485703 |
Respiratory depression | 92.27 | 13.16 | 68 | 30109 | 11942 | 50563005 |
Overdose | 91.62 | 13.16 | 191 | 29986 | 99536 | 50475411 |
Placental hypertrophy | 89.96 | 13.16 | 14 | 30163 | 0 | 50574947 |
Therapeutic product effect increased | 87.69 | 13.16 | 30 | 30147 | 986 | 50573961 |
Somnolence | 84.71 | 13.16 | 243 | 29934 | 154742 | 50420205 |
Drug screen positive | 84.31 | 13.16 | 41 | 30136 | 3361 | 50571586 |
Jaundice neonatal | 82.10 | 13.16 | 27 | 30150 | 784 | 50574163 |
Maternal exposure during breast feeding | 79.99 | 13.16 | 39 | 30138 | 3215 | 50571732 |
Toxicity to various agents | 76.43 | 13.16 | 289 | 29888 | 212210 | 50362737 |
Intentional product misuse | 76.00 | 13.16 | 115 | 30062 | 46619 | 50528328 |
Accidental exposure to product by child | 71.76 | 13.16 | 26 | 30151 | 1014 | 50573933 |
Oral administration complication | 71.04 | 13.16 | 16 | 30161 | 101 | 50574846 |
Drug delivery system removal | 70.68 | 13.16 | 11 | 30166 | 0 | 50574947 |
Product physical consistency issue | 69.85 | 13.16 | 21 | 30156 | 451 | 50574496 |
Abortion induced | 69.75 | 13.16 | 52 | 30125 | 9292 | 50565655 |
Hyperaesthesia | 69.00 | 13.16 | 49 | 30128 | 8124 | 50566823 |
Injection site pain | 68.47 | 13.16 | 182 | 29995 | 110842 | 50464105 |
Application site ulcer | 67.68 | 13.16 | 15 | 30162 | 87 | 50574860 |
Exposure via breast milk | 67.45 | 13.16 | 28 | 30149 | 1580 | 50573367 |
Euphoric mood | 66.37 | 13.16 | 37 | 30140 | 4018 | 50570929 |
Yawning | 63.17 | 13.16 | 23 | 30154 | 910 | 50574037 |
Application site scab | 63.16 | 13.16 | 16 | 30161 | 176 | 50574771 |
Arthropathy | 61.86 | 13.16 | 10 | 30167 | 157896 | 50417051 |
Blepharospasm | 59.74 | 13.16 | 31 | 30146 | 2917 | 50572030 |
Systemic lupus erythematosus | 59.57 | 13.16 | 7 | 30170 | 140615 | 50434332 |
Application site dermatitis | 59.29 | 13.16 | 15 | 30162 | 164 | 50574783 |
Drug use disorder | 58.53 | 13.16 | 31 | 30146 | 3041 | 50571906 |
Treatment failure | 57.94 | 13.16 | 7 | 30170 | 137630 | 50437317 |
Rhesus incompatibility | 57.86 | 13.16 | 13 | 30164 | 81 | 50574866 |
Drug screen negative | 57.75 | 13.16 | 16 | 30161 | 254 | 50574693 |
Injection site extravasation | 56.56 | 13.16 | 42 | 30135 | 7459 | 50567488 |
Injection site infection | 56.50 | 13.16 | 25 | 30152 | 1651 | 50573296 |
Selective abortion | 55.85 | 13.16 | 14 | 30163 | 147 | 50574800 |
Sinusitis | 54.42 | 13.16 | 17 | 30160 | 170541 | 50404406 |
Infusion related reaction | 53.92 | 13.16 | 17 | 30160 | 169540 | 50405407 |
Stress cardiomyopathy | 52.50 | 13.16 | 41 | 30136 | 7846 | 50567101 |
Breakthrough pain | 51.74 | 13.16 | 21 | 30156 | 1118 | 50573829 |
Application site haemorrhage | 50.92 | 13.16 | 20 | 30157 | 977 | 50573970 |
Alopecia | 49.49 | 13.16 | 44 | 30133 | 245003 | 50329944 |
Hallucination | 48.34 | 13.16 | 94 | 30083 | 46563 | 50528384 |
Pyrexia | 47.65 | 13.16 | 97 | 30080 | 380106 | 50194841 |
Foetal growth restriction | 47.51 | 13.16 | 36 | 30141 | 6591 | 50568356 |
Product dispensing issue | 47.37 | 13.16 | 11 | 30166 | 81 | 50574866 |
Miosis | 46.84 | 13.16 | 35 | 30142 | 6275 | 50568672 |
Device leakage | 46.77 | 13.16 | 34 | 30143 | 5844 | 50569103 |
Contraindicated product administered | 45.49 | 13.16 | 16 | 30161 | 148942 | 50426005 |
Joint swelling | 44.95 | 13.16 | 48 | 30129 | 245238 | 50329709 |
Fatigue | 44.84 | 13.16 | 244 | 29933 | 707357 | 49867590 |
Swelling | 44.37 | 13.16 | 33 | 30144 | 200839 | 50374108 |
Taste disorder | 44.33 | 13.16 | 38 | 30139 | 8286 | 50566661 |
Disturbance in attention | 42.76 | 13.16 | 71 | 30106 | 31115 | 50543832 |
Drug detoxification | 41.95 | 13.16 | 11 | 30166 | 140 | 50574807 |
Diarrhoea | 41.75 | 13.16 | 195 | 29982 | 588281 | 49986666 |
Intentional underdose | 41.55 | 13.16 | 20 | 30157 | 1602 | 50573345 |
Alcohol abuse | 41.44 | 13.16 | 21 | 30156 | 1880 | 50573067 |
Drug diversion | 41.38 | 13.16 | 16 | 30161 | 749 | 50574198 |
Subchondral insufficiency fracture | 41.25 | 13.16 | 9 | 30168 | 48 | 50574899 |
Injection site cellulitis | 41.14 | 13.16 | 18 | 30159 | 1157 | 50573790 |
Nasopharyngitis | 40.95 | 13.16 | 33 | 30144 | 192894 | 50382053 |
Rheumatoid arthritis | 40.13 | 13.16 | 37 | 30140 | 202513 | 50372434 |
Bradycardia foetal | 39.51 | 13.16 | 13 | 30164 | 378 | 50574569 |
Dermatitis contact | 39.13 | 13.16 | 36 | 30141 | 8610 | 50566337 |
17 ketosteroids urine abnormal | 38.55 | 13.16 | 6 | 30171 | 0 | 50574947 |
Suicidal ideation | 38.46 | 13.16 | 95 | 30082 | 55290 | 50519657 |
Impaired reasoning | 38.21 | 13.16 | 9 | 30168 | 71 | 50574876 |
Application site odour | 38.16 | 13.16 | 8 | 30169 | 34 | 50574913 |
Low birth weight baby | 37.91 | 13.16 | 30 | 30147 | 5851 | 50569096 |
Prescription drug used without a prescription | 37.70 | 13.16 | 19 | 30158 | 1681 | 50573266 |
Abdominal discomfort | 37.45 | 13.16 | 50 | 30127 | 231591 | 50343356 |
Infection | 37.43 | 13.16 | 29 | 30148 | 172925 | 50402022 |
Poor feeding infant | 36.73 | 13.16 | 11 | 30166 | 233 | 50574714 |
Hepatic enzyme increased | 36.71 | 13.16 | 18 | 30159 | 137362 | 50437585 |
Application site induration | 36.12 | 13.16 | 6 | 30171 | 3 | 50574944 |
Accidental overdose | 35.99 | 13.16 | 51 | 30126 | 19482 | 50555465 |
Application site inflammation | 35.83 | 13.16 | 12 | 30165 | 369 | 50574578 |
Cough | 35.16 | 13.16 | 56 | 30121 | 241208 | 50333739 |
Arthralgia | 34.96 | 13.16 | 139 | 30038 | 438563 | 50136384 |
Glossodynia | 34.29 | 13.16 | 13 | 30164 | 115556 | 50459391 |
Respiratory arrest | 34.22 | 13.16 | 63 | 30114 | 29946 | 50545001 |
Therapy naive | 33.16 | 13.16 | 7 | 30170 | 31 | 50574916 |
Neutropenia | 33.06 | 13.16 | 24 | 30153 | 147941 | 50427006 |
Off label use | 31.97 | 13.16 | 160 | 30017 | 474266 | 50100681 |
Skin irritation | 30.82 | 13.16 | 30 | 30147 | 7697 | 50567250 |
Application site bruise | 30.32 | 13.16 | 10 | 30167 | 293 | 50574654 |
Injection site abscess | 30.14 | 13.16 | 14 | 30163 | 1035 | 50573912 |
Premature baby | 29.62 | 13.16 | 45 | 30132 | 18292 | 50556655 |
Epilepsy | 29.43 | 13.16 | 49 | 30128 | 21518 | 50553429 |
Application site papules | 29.31 | 13.16 | 7 | 30170 | 59 | 50574888 |
Haemoglobin decreased | 29.25 | 13.16 | 20 | 30157 | 127196 | 50447751 |
Febrile neutropenia | 28.94 | 13.16 | 11 | 30166 | 97656 | 50477291 |
Platelet count decreased | 28.78 | 13.16 | 12 | 30165 | 100714 | 50474233 |
White blood cell count decreased | 28.69 | 13.16 | 17 | 30160 | 116705 | 50458242 |
Product colour issue | 27.61 | 13.16 | 11 | 30166 | 558 | 50574389 |
Foetal malformation | 27.19 | 13.16 | 8 | 30169 | 159 | 50574788 |
Monoplegia | 26.57 | 13.16 | 18 | 30159 | 2765 | 50572182 |
Therapeutic response shortened | 26.36 | 13.16 | 27 | 30150 | 7362 | 50567585 |
Unresponsive to stimuli | 26.19 | 13.16 | 57 | 30120 | 30552 | 50544395 |
Eyelid retraction | 26.10 | 13.16 | 6 | 30171 | 42 | 50574905 |
Faecaloma | 25.41 | 13.16 | 26 | 30151 | 7082 | 50567865 |
Pneumonia | 24.67 | 13.16 | 129 | 30048 | 378272 | 50196675 |
Maternal drugs affecting foetus | 24.67 | 13.16 | 22 | 30155 | 5055 | 50569892 |
Dermatitis allergic | 24.60 | 13.16 | 34 | 30143 | 12686 | 50562261 |
Defaecation disorder | 24.59 | 13.16 | 10 | 30167 | 535 | 50574412 |
Genitourinary symptom | 24.57 | 13.16 | 6 | 30171 | 56 | 50574891 |
Thrombocytopenia | 24.47 | 13.16 | 24 | 30153 | 127649 | 50447298 |
Gastrointestinal disorder | 24.30 | 13.16 | 13 | 30164 | 94443 | 50480504 |
Neurosis | 24.11 | 13.16 | 8 | 30169 | 239 | 50574708 |
Judgement impaired | 23.97 | 13.16 | 10 | 30167 | 571 | 50574376 |
Tooth hypoplasia | 23.77 | 13.16 | 6 | 30171 | 65 | 50574882 |
Vulvar basal cell carcinoma | 23.18 | 13.16 | 5 | 30172 | 25 | 50574922 |
Hypersensitivity | 22.78 | 13.16 | 60 | 30117 | 215101 | 50359846 |
Extra dose administered | 22.71 | 13.16 | 21 | 30156 | 5055 | 50569892 |
Musculoskeletal stiffness | 22.56 | 13.16 | 26 | 30151 | 128455 | 50446492 |
Foetal death | 22.39 | 13.16 | 26 | 30151 | 8154 | 50566793 |
Impaired healing | 22.16 | 13.16 | 7 | 30170 | 69779 | 50505168 |
Product dose omission issue | 22.05 | 13.16 | 48 | 30129 | 183790 | 50391157 |
Maternal use of illicit drugs | 22.04 | 13.16 | 4 | 30173 | 6 | 50574941 |
Victim of sexual abuse | 21.61 | 13.16 | 9 | 30168 | 512 | 50574435 |
Congenital coronary artery malformation | 21.50 | 13.16 | 6 | 30171 | 98 | 50574849 |
Endocarditis staphylococcal | 21.38 | 13.16 | 8 | 30169 | 342 | 50574605 |
Injection site ulcer | 21.23 | 13.16 | 9 | 30168 | 535 | 50574412 |
Vomiting | 20.88 | 13.16 | 388 | 29789 | 460370 | 50114577 |
Product contamination | 20.83 | 13.16 | 9 | 30168 | 561 | 50574386 |
Hypertension | 20.79 | 13.16 | 61 | 30116 | 211142 | 50363805 |
Somnolence neonatal | 20.75 | 13.16 | 6 | 30171 | 112 | 50574835 |
Accidental poisoning | 20.36 | 13.16 | 9 | 30168 | 593 | 50574354 |
Echocardiogram abnormal | 20.26 | 13.16 | 11 | 30166 | 1134 | 50573813 |
Application site infection | 19.90 | 13.16 | 5 | 30172 | 53 | 50574894 |
Sedation | 19.67 | 13.16 | 51 | 30126 | 30559 | 50544388 |
Weight increased | 19.38 | 13.16 | 59 | 30118 | 201832 | 50373115 |
Gastrointestinal hypomotility | 19.36 | 13.16 | 10 | 30167 | 932 | 50574015 |
Product substitution issue | 19.26 | 13.16 | 32 | 30145 | 14025 | 50560922 |
Neonatal aspiration | 19.17 | 13.16 | 6 | 30171 | 148 | 50574799 |
Urinary incontinence | 19.17 | 13.16 | 48 | 30129 | 28160 | 50546787 |
Small for dates baby | 18.66 | 13.16 | 16 | 30161 | 3489 | 50571458 |
Focal segmental glomerulosclerosis | 18.64 | 13.16 | 11 | 30166 | 1330 | 50573617 |
Radial nerve palsy | 18.63 | 13.16 | 8 | 30169 | 491 | 50574456 |
Stillbirth | 18.13 | 13.16 | 20 | 30157 | 5932 | 50569015 |
Injection site erosion | 17.95 | 13.16 | 5 | 30172 | 81 | 50574866 |
Enlarged uvula | 17.93 | 13.16 | 6 | 30171 | 184 | 50574763 |
Injection site oedema | 17.92 | 13.16 | 10 | 30167 | 1088 | 50573859 |
Product prescribing error | 17.89 | 13.16 | 39 | 30138 | 20922 | 50554025 |
Nausea | 17.86 | 13.16 | 548 | 29629 | 704850 | 49870097 |
Agitation | 17.81 | 13.16 | 71 | 30106 | 53313 | 50521634 |
Application site pustules | 17.79 | 13.16 | 4 | 30173 | 25 | 50574922 |
Substance dependence | 17.51 | 13.16 | 6 | 30171 | 198 | 50574749 |
Application site discomfort | 17.37 | 13.16 | 7 | 30170 | 366 | 50574581 |
Hypersomnia | 17.27 | 13.16 | 32 | 30145 | 15282 | 50559665 |
Confusional state | 16.74 | 13.16 | 177 | 30000 | 185751 | 50389196 |
Blood cholesterol increased | 16.72 | 13.16 | 6 | 30171 | 55209 | 50519738 |
Irritable bowel syndrome | 16.62 | 13.16 | 5 | 30172 | 51436 | 50523511 |
Faeces soft | 16.56 | 13.16 | 16 | 30161 | 4068 | 50570879 |
Ill-defined disorder | 16.45 | 13.16 | 6 | 30171 | 54648 | 50520299 |
Bruxism | 16.43 | 13.16 | 14 | 30163 | 3026 | 50571921 |
Cataract | 16.40 | 13.16 | 4 | 30173 | 47296 | 50527651 |
Delirium | 16.28 | 13.16 | 55 | 30122 | 38137 | 50536810 |
Application site perspiration | 15.98 | 13.16 | 3 | 30174 | 6 | 50574941 |
Application site laceration | 15.98 | 13.16 | 3 | 30174 | 6 | 50574941 |
Wound | 15.92 | 13.16 | 24 | 30153 | 105770 | 50469177 |
Sinus arrhythmia | 15.87 | 13.16 | 10 | 30167 | 1359 | 50573588 |
Pancytopenia | 15.86 | 13.16 | 16 | 30161 | 84014 | 50490933 |
Dyspnoea | 15.74 | 13.16 | 231 | 29946 | 547377 | 50027570 |
Interstitial lung disease | 15.73 | 13.16 | 6 | 30171 | 53170 | 50521777 |
Depressed level of consciousness | 15.68 | 13.16 | 67 | 30110 | 51886 | 50523061 |
Premature labour | 15.56 | 13.16 | 26 | 30151 | 11450 | 50563497 |
Product odour abnormal | 15.40 | 13.16 | 9 | 30168 | 1068 | 50573879 |
Condition aggravated | 15.29 | 13.16 | 109 | 30068 | 296949 | 50277998 |
Disease progression | 15.16 | 13.16 | 21 | 30156 | 95845 | 50479102 |
Product size issue | 15.05 | 13.16 | 6 | 30171 | 305 | 50574642 |
Repetitive strain injury | 14.89 | 13.16 | 5 | 30172 | 155 | 50574792 |
Lack of application site rotation | 14.88 | 13.16 | 3 | 30174 | 10 | 50574937 |
Therapeutic response increased | 14.84 | 13.16 | 6 | 30171 | 316 | 50574631 |
Migraine | 14.83 | 13.16 | 86 | 30091 | 75194 | 50499753 |
Influenza | 14.78 | 13.16 | 19 | 30158 | 89519 | 50485428 |
Therapy non-responder | 14.69 | 13.16 | 6 | 30171 | 51016 | 50523931 |
Application site warmth | 14.57 | 13.16 | 5 | 30172 | 166 | 50574781 |
Adjacent segment degeneration | 14.46 | 13.16 | 3 | 30174 | 12 | 50574935 |
Femoral neck fracture | 14.45 | 13.16 | 20 | 30157 | 7470 | 50567477 |
Oral mucosal blistering | 14.37 | 13.16 | 16 | 30161 | 4796 | 50570151 |
Bradypnoea | 14.30 | 13.16 | 13 | 30164 | 3061 | 50571886 |
Persistent depressive disorder | 14.23 | 13.16 | 8 | 30169 | 883 | 50574064 |
Asthenia | 14.12 | 13.16 | 122 | 30055 | 318920 | 50256027 |
Hepatitis C | 14.09 | 13.16 | 16 | 30161 | 4901 | 50570046 |
Reversible cerebral vasoconstriction syndrome | 14.07 | 13.16 | 11 | 30166 | 2108 | 50572839 |
Application site paraesthesia | 14.02 | 13.16 | 4 | 30173 | 71 | 50574876 |
Neutrophil count decreased | 13.94 | 13.16 | 5 | 30172 | 46021 | 50528926 |
Lack of administration site rotation | 13.91 | 13.16 | 3 | 30174 | 15 | 50574932 |
Dental discomfort | 13.90 | 13.16 | 6 | 30171 | 373 | 50574574 |
Feeling of body temperature change | 13.87 | 13.16 | 15 | 30162 | 4352 | 50570595 |
Product preparation error | 13.86 | 13.16 | 15 | 30162 | 4357 | 50570590 |
Injection site inflammation | 13.84 | 13.16 | 13 | 30164 | 3192 | 50571755 |
Ankyloglossia congenital | 13.70 | 13.16 | 5 | 30172 | 199 | 50574748 |
Product quality issue | 13.65 | 13.16 | 45 | 30132 | 30813 | 50544134 |
Discoloured vomit | 13.63 | 13.16 | 7 | 30170 | 644 | 50574303 |
Application site hypersensitivity | 13.61 | 13.16 | 5 | 30172 | 203 | 50574744 |
Substance abuser | 13.60 | 13.16 | 3 | 30174 | 17 | 50574930 |
Bronchitis | 13.49 | 13.16 | 26 | 30151 | 104133 | 50470814 |
Mental disorder | 13.48 | 13.16 | 36 | 30141 | 21955 | 50552992 |
Cystic lymphangioma | 13.45 | 13.16 | 3 | 30174 | 18 | 50574929 |
Anaemia | 13.30 | 13.16 | 92 | 30085 | 252364 | 50322583 |
Premature rupture of membranes | 13.28 | 13.16 | 15 | 30162 | 4565 | 50570382 |
Restlessness | 13.26 | 13.16 | 39 | 30138 | 25134 | 50549813 |
Dyspnoea exertional | 13.25 | 13.16 | 7 | 30170 | 51226 | 50523721 |
Drug abuser | 13.24 | 13.16 | 12 | 30165 | 2816 | 50572131 |
Learning disability | 13.20 | 13.16 | 5 | 30172 | 221 | 50574726 |
Psoriasis | 13.18 | 13.16 | 13 | 30164 | 68987 | 50505960 |
MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
---|---|---|---|---|---|---|
Drug withdrawal syndrome | 1636.29 | 14.24 | 624 | 27865 | 17360 | 29528678 |
Drug abuse | 1434.74 | 14.24 | 913 | 27576 | 78970 | 29467068 |
Drug dependence | 935.67 | 14.24 | 439 | 28050 | 20542 | 29525496 |
Intentional product misuse | 738.66 | 14.24 | 443 | 28046 | 34218 | 29511820 |
Product adhesion issue | 569.84 | 14.24 | 154 | 28335 | 1317 | 29544721 |
Drug withdrawal syndrome neonatal | 513.34 | 14.24 | 172 | 28317 | 3223 | 29542815 |
Substance abuse | 474.26 | 14.24 | 195 | 28294 | 6592 | 29539446 |
Miosis | 469.20 | 14.24 | 203 | 28286 | 7806 | 29538232 |
Injection site pain | 454.76 | 14.24 | 319 | 28170 | 32127 | 29513911 |
Toxicity to various agents | 441.32 | 14.24 | 677 | 27812 | 172984 | 29373054 |
Application site pruritus | 370.61 | 14.24 | 107 | 28382 | 1190 | 29544848 |
Intentional product use issue | 308.06 | 14.24 | 284 | 28205 | 42214 | 29503824 |
Application site rash | 286.58 | 14.24 | 78 | 28411 | 686 | 29545352 |
Application site erythema | 284.51 | 14.24 | 98 | 28391 | 2001 | 29544037 |
Inadequate analgesia | 273.05 | 14.24 | 101 | 28388 | 2553 | 29543485 |
Alcohol abuse | 244.46 | 14.24 | 107 | 28382 | 4226 | 29541812 |
Overdose | 230.21 | 14.24 | 331 | 28158 | 79488 | 29466550 |
Withdrawal syndrome | 227.19 | 14.24 | 138 | 28351 | 10854 | 29535184 |
Drug use disorder | 221.04 | 14.24 | 93 | 28396 | 3329 | 29542709 |
Foetal exposure during pregnancy | 212.35 | 14.24 | 209 | 28280 | 33658 | 29512380 |
Application site burn | 203.43 | 14.24 | 46 | 28443 | 166 | 29545872 |
Coma | 197.89 | 14.24 | 216 | 28273 | 39234 | 29506804 |
Injection site infection | 178.27 | 14.24 | 56 | 28433 | 845 | 29545193 |
Drug screen positive | 170.50 | 14.24 | 80 | 28409 | 3721 | 29542317 |
Application site vesicles | 165.06 | 14.24 | 47 | 28442 | 495 | 29545543 |
Respiratory depression | 159.69 | 14.24 | 120 | 28369 | 13403 | 29532635 |
Injection site abscess | 156.84 | 14.24 | 48 | 28441 | 661 | 29545377 |
Application site pain | 151.29 | 14.24 | 58 | 28431 | 1621 | 29544417 |
Somnolence | 150.79 | 14.24 | 300 | 28189 | 93655 | 29452383 |
Injection site ulcer | 149.55 | 14.24 | 37 | 28452 | 213 | 29545825 |
Wrong technique in product usage process | 143.68 | 14.24 | 164 | 28325 | 31264 | 29514774 |
Drug detoxification | 138.97 | 14.24 | 33 | 28456 | 155 | 29545883 |
Injection site erythema | 136.93 | 14.24 | 111 | 28378 | 13845 | 29532193 |
Accidental overdose | 132.02 | 14.24 | 120 | 28369 | 17473 | 29528565 |
Drug delivery system removal | 118.93 | 14.24 | 20 | 28469 | 0 | 29546038 |
Maternal exposure during breast feeding | 108.19 | 14.24 | 44 | 28445 | 1442 | 29544596 |
Injection site extravasation | 105.40 | 14.24 | 50 | 28439 | 2383 | 29543655 |
Asphyxia | 100.31 | 14.24 | 63 | 28426 | 5252 | 29540786 |
Application site irritation | 99.29 | 14.24 | 33 | 28456 | 601 | 29545437 |
Brain oedema | 92.94 | 14.24 | 84 | 28405 | 12136 | 29533902 |
Drug screen negative | 87.44 | 14.24 | 22 | 28467 | 137 | 29545901 |
Injection site erosion | 84.36 | 14.24 | 19 | 28470 | 67 | 29545971 |
Febrile neutropenia | 82.14 | 14.24 | 7 | 28482 | 112233 | 29433805 |
Agitation | 81.17 | 14.24 | 163 | 28326 | 51141 | 29494897 |
Injection site necrosis | 81.04 | 14.24 | 25 | 28464 | 354 | 29545684 |
Application site reaction | 74.75 | 14.24 | 24 | 28465 | 390 | 29545648 |
Pyrexia | 74.69 | 14.24 | 101 | 28388 | 287521 | 29258517 |
Jaundice neonatal | 74.03 | 14.24 | 32 | 28457 | 1224 | 29544814 |
Euphoric mood | 73.46 | 14.24 | 50 | 28439 | 4775 | 29541263 |
Accidental exposure to product by child | 71.72 | 14.24 | 32 | 28457 | 1322 | 29544716 |
Brachial artery entrapment syndrome | 71.36 | 14.24 | 12 | 28477 | 0 | 29546038 |
Aggression | 71.26 | 14.24 | 125 | 28364 | 35416 | 29510622 |
Inappropriate schedule of product administration | 71.18 | 14.24 | 142 | 28347 | 44330 | 29501708 |
Logorrhoea | 69.59 | 14.24 | 37 | 28452 | 2251 | 29543787 |
Hyperhidrosis | 67.47 | 14.24 | 174 | 28315 | 64366 | 29481672 |
Diarrhoea | 66.80 | 14.24 | 138 | 28351 | 332560 | 29213478 |
Drug diversion | 65.80 | 14.24 | 26 | 28463 | 789 | 29545249 |
Poor feeding infant | 64.64 | 14.24 | 22 | 28467 | 432 | 29545606 |
Application site dryness | 64.39 | 14.24 | 14 | 28475 | 40 | 29545998 |
Pneumonia | 64.10 | 14.24 | 133 | 28356 | 320039 | 29225999 |
Prescription drug used without a prescription | 63.31 | 14.24 | 29 | 28460 | 1275 | 29544763 |
Cluster headache | 63.18 | 14.24 | 22 | 28467 | 464 | 29545574 |
Bradypnoea | 62.83 | 14.24 | 35 | 28454 | 2336 | 29543702 |
Dysarthria | 62.33 | 14.24 | 109 | 28380 | 30802 | 29515236 |
Congenital multiplex arthrogryposis | 61.78 | 14.24 | 13 | 28476 | 30 | 29546008 |
Injection site vesicles | 60.75 | 14.24 | 22 | 28467 | 522 | 29545516 |
Injection site discharge | 60.67 | 14.24 | 15 | 28474 | 86 | 29545952 |
Atrial fibrillation | 60.13 | 14.24 | 14 | 28475 | 105632 | 29440406 |
Intentional removal of drug delivery system by patient | 59.46 | 14.24 | 10 | 28479 | 0 | 29546038 |
Dermo-hypodermitis | 59.14 | 14.24 | 18 | 28471 | 243 | 29545795 |
Cough | 57.60 | 14.24 | 25 | 28464 | 126702 | 29419336 |
Deafness neurosensory | 54.87 | 14.24 | 33 | 28456 | 2545 | 29543493 |
Application site urticaria | 54.41 | 14.24 | 13 | 28476 | 63 | 29545975 |
Platelet count decreased | 53.69 | 14.24 | 17 | 28472 | 104655 | 29441383 |
Exposure via breast milk | 52.96 | 14.24 | 28 | 28461 | 1684 | 29544354 |
Accidental poisoning | 52.88 | 14.24 | 20 | 28469 | 538 | 29545500 |
Product dispensing issue | 51.59 | 14.24 | 10 | 28479 | 12 | 29546026 |
Pulmonary oedema | 50.74 | 14.24 | 121 | 28368 | 42614 | 29503424 |
Anaemia | 50.63 | 14.24 | 72 | 28417 | 200879 | 29345159 |
Tremor neonatal | 49.06 | 14.24 | 17 | 28472 | 353 | 29545685 |
Hypotension | 48.60 | 14.24 | 70 | 28419 | 194284 | 29351754 |
Application site swelling | 48.01 | 14.24 | 15 | 28474 | 222 | 29545816 |
Injection site cellulitis | 47.52 | 14.24 | 18 | 28471 | 486 | 29545552 |
White blood cell count decreased | 47.52 | 14.24 | 11 | 28478 | 83351 | 29462687 |
Drug abuser | 47.48 | 14.24 | 35 | 28454 | 3792 | 29542246 |
Impaired driving ability | 47.45 | 14.24 | 29 | 28460 | 2302 | 29543736 |
Therapeutic product effect increased | 47.34 | 14.24 | 19 | 28470 | 601 | 29545437 |
Hepatitis C | 46.73 | 14.24 | 50 | 28439 | 8860 | 29537178 |
Sarcopenia | 45.57 | 14.24 | 16 | 28473 | 346 | 29545692 |
Injection site warmth | 45.53 | 14.24 | 26 | 28463 | 1820 | 29544218 |
Low birth weight baby | 45.53 | 14.24 | 43 | 28446 | 6565 | 29539473 |
Endocarditis staphylococcal | 45.14 | 14.24 | 16 | 28473 | 356 | 29545682 |
Application site exfoliation | 44.97 | 14.24 | 12 | 28477 | 97 | 29545941 |
Application site discolouration | 44.64 | 14.24 | 14 | 28475 | 210 | 29545828 |
Injection site irritation | 43.58 | 14.24 | 21 | 28468 | 1036 | 29545002 |
Disorientation | 43.37 | 14.24 | 91 | 28398 | 29424 | 29516614 |
Premature baby | 42.99 | 14.24 | 67 | 28422 | 17213 | 29528825 |
Poisoning | 42.03 | 14.24 | 50 | 28439 | 9943 | 29536095 |
Cardiac failure congestive | 41.91 | 14.24 | 11 | 28478 | 76570 | 29469468 |
Myelopathy | 41.32 | 14.24 | 25 | 28464 | 1949 | 29544089 |
Therapeutic product effect decreased | 41.19 | 14.24 | 89 | 28400 | 29362 | 29516676 |
Aptyalism | 40.57 | 14.24 | 14 | 28475 | 287 | 29545751 |
Fatigue | 40.32 | 14.24 | 163 | 28326 | 316658 | 29229380 |
Endocarditis | 39.01 | 14.24 | 37 | 28452 | 5679 | 29540359 |
Application site hypersensitivity | 38.79 | 14.24 | 11 | 28478 | 114 | 29545924 |
Application site erosion | 38.61 | 14.24 | 10 | 28479 | 71 | 29545967 |
Product solubility abnormal | 38.31 | 14.24 | 15 | 28474 | 444 | 29545594 |
Restlessness | 38.19 | 14.24 | 73 | 28416 | 22072 | 29523966 |
Dyspnoea | 37.96 | 14.24 | 174 | 28315 | 326558 | 29219480 |
Application site scar | 37.86 | 14.24 | 8 | 28481 | 19 | 29546019 |
Oral administration complication | 37.60 | 14.24 | 9 | 28480 | 44 | 29545994 |
Intentional underdose | 37.14 | 14.24 | 16 | 28473 | 607 | 29545431 |
Product packaging quantity issue | 37.10 | 14.24 | 17 | 28472 | 748 | 29545290 |
Decreased gait velocity | 36.80 | 14.24 | 11 | 28478 | 139 | 29545899 |
Congestive hepatopathy | 36.63 | 14.24 | 22 | 28467 | 1692 | 29544346 |
Application site discharge | 36.45 | 14.24 | 11 | 28478 | 144 | 29545894 |
Neutropenia | 36.40 | 14.24 | 44 | 28445 | 131667 | 29414371 |
Arthralgia | 36.15 | 14.24 | 49 | 28440 | 139568 | 29406470 |
Housebound | 36.03 | 14.24 | 12 | 28477 | 220 | 29545818 |
Haemoglobin decreased | 35.85 | 14.24 | 31 | 28458 | 108344 | 29437694 |
Hallucination | 35.35 | 14.24 | 109 | 28380 | 44603 | 29501435 |
Product dose omission issue | 35.13 | 14.24 | 25 | 28464 | 96358 | 29449680 |
Prescription form tampering | 35.03 | 14.24 | 14 | 28475 | 438 | 29545600 |
Spinal shock | 34.93 | 14.24 | 8 | 28481 | 31 | 29546007 |
Injection site pruritus | 34.58 | 14.24 | 35 | 28454 | 5814 | 29540224 |
Injection site swelling | 34.57 | 14.24 | 44 | 28445 | 9373 | 29536665 |
Skin irritation | 34.57 | 14.24 | 31 | 28458 | 4430 | 29541608 |
Glomerulonephritis acute | 34.50 | 14.24 | 9 | 28480 | 66 | 29545972 |
Incorrect route of product administration | 34.30 | 14.24 | 47 | 28442 | 10754 | 29535284 |
Cerebrovascular accident | 33.63 | 14.24 | 16 | 28473 | 76895 | 29469143 |
Injection site inflammation | 32.52 | 14.24 | 15 | 28474 | 670 | 29545368 |
Asthenia | 32.48 | 14.24 | 103 | 28386 | 215147 | 29330891 |
Neuropathy peripheral | 32.26 | 14.24 | 14 | 28475 | 71013 | 29475025 |
Acute kidney injury | 32.14 | 14.24 | 139 | 28350 | 265128 | 29280910 |
Pleural effusion | 31.37 | 14.24 | 15 | 28474 | 71893 | 29474145 |
Drug interaction | 30.46 | 14.24 | 307 | 28182 | 197078 | 29348960 |
Feeding intolerance | 30.46 | 14.24 | 9 | 28480 | 109 | 29545929 |
Disease progression | 30.17 | 14.24 | 21 | 28468 | 81895 | 29464143 |
Bradyphrenia | 30.14 | 14.24 | 28 | 28461 | 4186 | 29541852 |
Foetal distress syndrome | 29.94 | 14.24 | 16 | 28473 | 983 | 29545055 |
Respiratory arrest | 29.42 | 14.24 | 72 | 28417 | 25761 | 29520277 |
Epistaxis | 29.10 | 14.24 | 7 | 28482 | 51697 | 29494341 |
Product administered at inappropriate site | 29.01 | 14.24 | 19 | 28470 | 1701 | 29544337 |
Infusion related reaction | 28.87 | 14.24 | 4 | 28485 | 43882 | 29502156 |
Breech presentation | 28.63 | 14.24 | 9 | 28480 | 136 | 29545902 |
Interstitial lung disease | 28.48 | 14.24 | 10 | 28479 | 57708 | 29488330 |
Vestibular ischaemia | 28.47 | 14.24 | 6 | 28483 | 14 | 29546024 |
Malignant neoplasm progression | 28.46 | 14.24 | 18 | 28471 | 73841 | 29472197 |
Sedation | 28.33 | 14.24 | 56 | 28433 | 17349 | 29528689 |
Substance dependence | 27.32 | 14.24 | 11 | 28478 | 351 | 29545687 |
Depressed level of consciousness | 27.31 | 14.24 | 88 | 28401 | 36854 | 29509184 |
Troponin T increased | 27.24 | 14.24 | 17 | 28472 | 1400 | 29544638 |
Substance use disorder | 26.47 | 14.24 | 10 | 28479 | 268 | 29545770 |
Road traffic accident | 26.46 | 14.24 | 51 | 28438 | 15510 | 29530528 |
Ear deformity acquired | 26.27 | 14.24 | 5 | 28484 | 5 | 29546033 |
Death | 26.05 | 14.24 | 468 | 28021 | 341616 | 29204422 |
Suicidal ideation | 25.94 | 14.24 | 83 | 28406 | 34633 | 29511405 |
Application site scab | 25.57 | 14.24 | 7 | 28482 | 63 | 29545975 |
Blood creatinine increased | 25.05 | 14.24 | 27 | 28462 | 85075 | 29460963 |
Product use issue | 24.98 | 14.24 | 107 | 28382 | 51337 | 29494701 |
Blood glucose increased | 24.68 | 14.24 | 13 | 28476 | 58971 | 29487067 |
Drug effect less than expected | 24.64 | 14.24 | 9 | 28480 | 219 | 29545819 |
Respiratory rate decreased | 24.60 | 14.24 | 18 | 28471 | 1927 | 29544111 |
Dehydration | 24.28 | 14.24 | 46 | 28443 | 114702 | 29431336 |
Injection site bruising | 24.09 | 14.24 | 33 | 28456 | 7547 | 29538491 |
Product use in unapproved indication | 24.01 | 14.24 | 29 | 28460 | 86846 | 29459192 |
Dependence | 23.99 | 14.24 | 14 | 28475 | 1021 | 29545017 |
Thrombosis | 23.89 | 14.24 | 6 | 28483 | 43039 | 29502999 |
Clumsiness | 23.86 | 14.24 | 16 | 28473 | 1490 | 29544548 |
Joint swelling | 23.81 | 14.24 | 9 | 28480 | 49621 | 29496417 |
Septic pulmonary embolism | 23.79 | 14.24 | 4 | 28485 | 0 | 29546038 |
Aspartate aminotransferase increased | 23.78 | 14.24 | 14 | 28475 | 59711 | 29486327 |
Vestibular disorder | 23.75 | 14.24 | 14 | 28475 | 1040 | 29544998 |
Agitation neonatal | 23.73 | 14.24 | 14 | 28475 | 1042 | 29544996 |
Haemorrhage | 23.67 | 14.24 | 7 | 28482 | 45065 | 29500973 |
Therapy naive | 23.62 | 14.24 | 5 | 28484 | 12 | 29546026 |
Hyperkalaemia | 23.60 | 14.24 | 15 | 28474 | 61377 | 29484661 |
Product physical issue | 23.46 | 14.24 | 18 | 28471 | 2070 | 29543968 |
Rash | 23.23 | 14.24 | 99 | 28390 | 189720 | 29356318 |
Joint hyperextension | 22.70 | 14.24 | 7 | 28482 | 99 | 29545939 |
Mastication disorder | 22.51 | 14.24 | 14 | 28475 | 1146 | 29544892 |
Application site haemorrhage | 22.04 | 14.24 | 10 | 28479 | 430 | 29545608 |
Back pain | 21.64 | 14.24 | 41 | 28448 | 102243 | 29443795 |
Wrong dose | 21.57 | 14.24 | 10 | 28479 | 452 | 29545586 |
Hyponatraemia | 21.57 | 14.24 | 20 | 28469 | 67613 | 29478425 |
Chronic actinic dermatitis | 21.51 | 14.24 | 5 | 28484 | 21 | 29546017 |
Thrombocytopenia | 21.38 | 14.24 | 63 | 28426 | 134760 | 29411278 |
Coronary artery disease | 21.22 | 14.24 | 8 | 28481 | 44182 | 29501856 |
Coordination abnormal | 21.16 | 14.24 | 30 | 28459 | 7084 | 29538954 |
Altered state of consciousness | 21.14 | 14.24 | 54 | 28435 | 19835 | 29526203 |
Accidental death | 21.09 | 14.24 | 17 | 28472 | 2101 | 29543937 |
Compartment syndrome | 20.92 | 14.24 | 18 | 28471 | 2434 | 29543604 |
Substance use | 20.87 | 14.24 | 10 | 28479 | 487 | 29545551 |
Hypoxic-ischaemic encephalopathy | 20.65 | 14.24 | 23 | 28466 | 4261 | 29541777 |
Neonatal aspiration | 20.28 | 14.24 | 6 | 28483 | 73 | 29545965 |
Pulmonary congestion | 20.22 | 14.24 | 40 | 28449 | 12396 | 29533642 |
COVID-19 | 20.02 | 14.24 | 5 | 28484 | 36009 | 29510029 |
International normalised ratio increased | 19.74 | 14.24 | 9 | 28480 | 44363 | 29501675 |
Unresponsive to stimuli | 19.61 | 14.24 | 61 | 28428 | 25065 | 29520973 |
Anxiety | 19.54 | 14.24 | 145 | 28344 | 85220 | 29460818 |
Electrocardiogram T wave alternans | 19.40 | 14.24 | 4 | 28485 | 8 | 29546030 |
Product substitution issue | 19.33 | 14.24 | 33 | 28456 | 9139 | 29536899 |
Delirium | 19.16 | 14.24 | 82 | 28407 | 39315 | 29506723 |
Herpes zoster | 19.16 | 14.24 | 3 | 28486 | 30049 | 29515989 |
Treatment failure | 18.92 | 14.24 | 6 | 28483 | 36933 | 29509105 |
Persecutory delusion | 18.85 | 14.24 | 16 | 28473 | 2125 | 29543913 |
Product contamination | 18.79 | 14.24 | 10 | 28479 | 609 | 29545429 |
Micrognathia | 18.65 | 14.24 | 8 | 28481 | 300 | 29545738 |
Myocardial infarction | 18.62 | 14.24 | 50 | 28439 | 110246 | 29435792 |
Laryngomalacia | 18.53 | 14.24 | 8 | 28481 | 305 | 29545733 |
Brief psychotic disorder with marked stressors | 18.45 | 14.24 | 7 | 28482 | 190 | 29545848 |
Emotional poverty | 18.38 | 14.24 | 9 | 28480 | 460 | 29545578 |
Renal failure | 18.38 | 14.24 | 56 | 28433 | 118543 | 29427495 |
Poisoning deliberate | 18.29 | 14.24 | 25 | 28464 | 5706 | 29540332 |
Embolia cutis medicamentosa | 18.24 | 14.24 | 7 | 28482 | 196 | 29545842 |
Pancytopenia | 17.89 | 14.24 | 33 | 28456 | 83135 | 29462903 |
Application site odour | 17.84 | 14.24 | 3 | 28486 | 0 | 29546038 |
Injection site ischaemia | 17.84 | 14.24 | 3 | 28486 | 0 | 29546038 |
Gastrointestinal haemorrhage | 17.60 | 14.24 | 31 | 28458 | 79502 | 29466536 |
Alcohol interaction | 17.50 | 14.24 | 17 | 28472 | 2686 | 29543352 |
Application site ulcer | 17.36 | 14.24 | 4 | 28485 | 16 | 29546022 |
Product colour issue | 17.18 | 14.24 | 8 | 28481 | 365 | 29545673 |
Victim of crime | 17.18 | 14.24 | 8 | 28481 | 365 | 29545673 |
Mydriasis | 17.13 | 14.24 | 25 | 28464 | 6060 | 29539978 |
Rectal haemorrhage | 17.02 | 14.24 | 6 | 28483 | 34543 | 29511495 |
Behavioural addiction | 16.98 | 14.24 | 4 | 28485 | 18 | 29546020 |
Deafness bilateral | 16.84 | 14.24 | 11 | 28478 | 980 | 29545058 |
Cyanosis | 16.84 | 14.24 | 35 | 28454 | 11232 | 29534806 |
Accidental exposure to product | 16.78 | 14.24 | 34 | 28455 | 10719 | 29535319 |
Product physical consistency issue | 16.73 | 14.24 | 8 | 28481 | 388 | 29545650 |
Disturbance in attention | 16.71 | 14.24 | 52 | 28437 | 21372 | 29524666 |
Multiple cardiac defects | 16.67 | 14.24 | 5 | 28484 | 64 | 29545974 |
Blood bilirubin increased | 16.50 | 14.24 | 6 | 28483 | 33887 | 29512151 |
Psychotic disorder | 16.43 | 14.24 | 50 | 28439 | 20304 | 29525734 |
Incoherent | 16.43 | 14.24 | 20 | 28469 | 4072 | 29541966 |
Respiratory failure | 16.41 | 14.24 | 44 | 28445 | 97087 | 29448951 |
Diabetes mellitus | 16.33 | 14.24 | 9 | 28480 | 39822 | 29506216 |
Neutrophil count decreased | 16.26 | 14.24 | 11 | 28478 | 43556 | 29502482 |
Infection | 16.02 | 14.24 | 31 | 28458 | 76720 | 29469318 |
Eschar | 15.99 | 14.24 | 9 | 28480 | 613 | 29545425 |
Weight increased | 15.97 | 14.24 | 31 | 28458 | 76636 | 29469402 |
Gun shot wound | 15.94 | 14.24 | 11 | 28478 | 1074 | 29544964 |
Dermal absorption impaired | 15.76 | 14.24 | 3 | 28486 | 3 | 29546035 |
Administration site abscess sterile | 15.76 | 14.24 | 3 | 28486 | 3 | 29546035 |
Acute cardiac event | 15.75 | 14.24 | 4 | 28485 | 26 | 29546012 |
Bronchitis | 15.60 | 14.24 | 8 | 28481 | 36860 | 29509178 |
Injection site scab | 15.49 | 14.24 | 4 | 28485 | 28 | 29546010 |
Infantile vomiting | 15.25 | 14.24 | 4 | 28485 | 30 | 29546008 |
Tachyphrenia | 15.20 | 14.24 | 11 | 28478 | 1158 | 29544880 |
Psoriasis | 15.19 | 14.24 | 6 | 28483 | 32221 | 29513817 |
Hallucinations, mixed | 15.19 | 14.24 | 15 | 28474 | 2418 | 29543620 |
Hyperglycaemia | 15.18 | 14.24 | 7 | 28482 | 34280 | 29511758 |
Pain in extremity | 15.14 | 14.24 | 55 | 28434 | 110378 | 29435660 |
Anaphylactic reaction | 15.00 | 14.24 | 4 | 28485 | 27569 | 29518469 |
Hypoventilation | 14.99 | 14.24 | 16 | 28473 | 2825 | 29543213 |
Neuromuscular blockade | 14.80 | 14.24 | 6 | 28483 | 195 | 29545843 |
Nasal septum deviation | 14.74 | 14.24 | 10 | 28479 | 949 | 29545089 |
Neonatal respiratory distress | 14.70 | 14.24 | 8 | 28481 | 510 | 29545528 |
Chronic hepatitis C | 14.67 | 14.24 | 7 | 28482 | 338 | 29545700 |
Off label use | 14.66 | 14.24 | 203 | 28286 | 300597 | 29245441 |
Acute myocardial infarction | 14.66 | 14.24 | 15 | 28474 | 48423 | 29497615 |
Injection site induration | 14.47 | 14.24 | 15 | 28474 | 2561 | 29543477 |
MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
---|---|---|---|---|---|---|
Drug abuse | 1620.19 | 12.68 | 1041 | 42256 | 131333 | 64324102 |
Drug withdrawal syndrome | 1429.47 | 12.68 | 598 | 42699 | 30693 | 64424742 |
Application site pruritus | 1121.12 | 12.68 | 293 | 43004 | 3246 | 64452189 |
Drug dependence | 1001.32 | 12.68 | 475 | 42822 | 32837 | 64422598 |
Product adhesion issue | 967.35 | 12.68 | 242 | 43055 | 2217 | 64453218 |
Application site erythema | 816.99 | 12.68 | 243 | 43054 | 4446 | 64450989 |
Intentional product misuse | 668.35 | 12.68 | 479 | 42818 | 71816 | 64383619 |
Application site rash | 600.62 | 12.68 | 158 | 43139 | 1796 | 64453639 |
Substance abuse | 552.85 | 12.68 | 215 | 43082 | 9077 | 64446358 |
Miosis | 524.05 | 12.68 | 229 | 43068 | 13037 | 64442398 |
Toxicity to various agents | 484.57 | 12.68 | 870 | 42427 | 362643 | 64092792 |
Application site pain | 483.48 | 12.68 | 159 | 43138 | 4089 | 64451346 |
Application site burn | 476.67 | 12.68 | 110 | 43187 | 686 | 64454749 |
Inadequate analgesia | 457.18 | 12.68 | 150 | 43147 | 3828 | 64451607 |
Application site vesicles | 450.31 | 12.68 | 116 | 43181 | 1206 | 64454229 |
Alcohol abuse | 298.27 | 12.68 | 115 | 43182 | 4737 | 64450698 |
Respiratory depression | 286.97 | 12.68 | 185 | 43112 | 23258 | 64432177 |
Overdose | 280.18 | 12.68 | 433 | 42864 | 159133 | 64296302 |
Withdrawal syndrome | 269.49 | 12.68 | 178 | 43119 | 23314 | 64432121 |
Drug use disorder | 257.01 | 12.68 | 110 | 43187 | 5944 | 64449491 |
Coma | 222.58 | 12.68 | 284 | 43013 | 87331 | 64368104 |
Intentional product use issue | 220.35 | 12.68 | 295 | 43002 | 95069 | 64360366 |
Somnolence | 200.47 | 12.68 | 430 | 42867 | 203215 | 64252220 |
Application site irritation | 195.57 | 12.68 | 63 | 43234 | 1513 | 64453922 |
Application site scar | 178.03 | 12.68 | 38 | 43259 | 155 | 64455280 |
Accidental overdose | 176.42 | 12.68 | 160 | 43137 | 33397 | 64422038 |
Application site dryness | 168.44 | 12.68 | 36 | 43261 | 148 | 64455287 |
Accidental exposure to product by child | 153.09 | 12.68 | 59 | 43238 | 2426 | 64453009 |
Application site discolouration | 141.57 | 12.68 | 41 | 43256 | 679 | 64454756 |
Drug screen positive | 139.91 | 12.68 | 71 | 43226 | 5658 | 64449777 |
Application site discharge | 134.83 | 12.68 | 33 | 43264 | 273 | 64455162 |
Wrong technique in product usage process | 130.53 | 12.68 | 188 | 43109 | 64786 | 64390649 |
Application site exfoliation | 127.27 | 12.68 | 32 | 43265 | 299 | 64455136 |
Application site urticaria | 116.36 | 12.68 | 28 | 43269 | 214 | 64455221 |
Application site erosion | 108.02 | 12.68 | 26 | 43271 | 199 | 64455236 |
Injection site abscess | 107.31 | 12.68 | 39 | 43258 | 1359 | 64454076 |
Agitation | 101.41 | 12.68 | 199 | 43098 | 88168 | 64367267 |
Asphyxia | 101.30 | 12.68 | 69 | 43228 | 9497 | 64445938 |
Injection site ulcer | 96.60 | 12.68 | 30 | 43267 | 637 | 64454798 |
Drug detoxification | 94.91 | 12.68 | 24 | 43273 | 230 | 64455205 |
Hyperhidrosis | 93.36 | 12.68 | 237 | 43060 | 124683 | 64330752 |
Injection site pain | 91.33 | 12.68 | 219 | 43078 | 111189 | 64344246 |
Aggression | 88.80 | 12.68 | 131 | 43166 | 46101 | 64409334 |
Injection site infection | 86.18 | 12.68 | 36 | 43261 | 1829 | 64453606 |
Brachial artery entrapment syndrome | 81.99 | 12.68 | 13 | 43284 | 0 | 64455435 |
Pyrexia | 80.99 | 12.68 | 158 | 43139 | 558486 | 63896949 |
Logorrhoea | 78.37 | 12.68 | 43 | 43254 | 4016 | 64451419 |
Inappropriate schedule of product administration | 77.34 | 12.68 | 183 | 43114 | 92103 | 64363332 |
Accidental poisoning | 77.21 | 12.68 | 31 | 43266 | 1422 | 64454013 |
Application site swelling | 76.95 | 12.68 | 25 | 43272 | 617 | 64454818 |
Brain oedema | 76.61 | 12.68 | 84 | 43213 | 21991 | 64433444 |
Bradypnoea | 73.89 | 12.68 | 45 | 43252 | 5114 | 64450321 |
Maternal exposure during pregnancy | 73.80 | 12.68 | 184 | 43113 | 95700 | 64359735 |
Product physical issue | 73.47 | 12.68 | 39 | 43258 | 3410 | 64452025 |
Febrile neutropenia | 73.08 | 12.68 | 18 | 43279 | 187639 | 64267796 |
Endocarditis staphylococcal | 72.88 | 12.68 | 24 | 43273 | 619 | 64454816 |
Death | 72.72 | 12.68 | 563 | 42734 | 482142 | 63973293 |
Application site reaction | 70.38 | 12.68 | 24 | 43273 | 691 | 64454744 |
Drug delivery system removal | 69.38 | 12.68 | 11 | 43286 | 0 | 64455435 |
Hallucination | 67.23 | 12.68 | 150 | 43147 | 72638 | 64382797 |
Drug diversion | 66.53 | 12.68 | 26 | 43271 | 1110 | 64454325 |
Drug withdrawal syndrome neonatal | 66.18 | 12.68 | 18 | 43279 | 234 | 64455201 |
Euphoric mood | 66.15 | 12.68 | 46 | 43251 | 6545 | 64448890 |
Infusion related reaction | 65.57 | 12.68 | 15 | 43282 | 164452 | 64290983 |
Hepatitis C | 64.80 | 12.68 | 56 | 43241 | 10959 | 64444476 |
Application site scab | 64.70 | 12.68 | 17 | 43280 | 192 | 64455243 |
Diarrhoea | 62.93 | 12.68 | 261 | 43036 | 722443 | 63732992 |
Disturbance in attention | 60.38 | 12.68 | 103 | 43194 | 40971 | 64414464 |
Product administered at inappropriate site | 60.19 | 12.68 | 33 | 43264 | 3077 | 64452358 |
Arthropathy | 59.64 | 12.68 | 6 | 43291 | 120961 | 64334474 |
Cluster headache | 58.85 | 12.68 | 22 | 43275 | 831 | 64454604 |
Intentional underdose | 57.64 | 12.68 | 28 | 43269 | 2030 | 64453405 |
Application site haemorrhage | 57.44 | 12.68 | 24 | 43273 | 1220 | 64454215 |
Respiratory arrest | 56.77 | 12.68 | 116 | 43181 | 52869 | 64402566 |
Disorientation | 56.05 | 12.68 | 119 | 43178 | 55709 | 64399726 |
Product solubility abnormal | 55.56 | 12.68 | 21 | 43276 | 818 | 64454617 |
Depressed level of consciousness | 55.17 | 12.68 | 149 | 43148 | 81287 | 64374148 |
Hyperaesthesia | 55.08 | 12.68 | 49 | 43248 | 9965 | 64445470 |
Drug interaction | 54.25 | 12.68 | 422 | 42875 | 361661 | 64093774 |
Application site ulcer | 53.17 | 12.68 | 13 | 43284 | 107 | 64455328 |
Skin irritation | 52.59 | 12.68 | 46 | 43251 | 9148 | 64446287 |
Drug abuser | 52.44 | 12.68 | 38 | 43259 | 5770 | 64449665 |
Cough | 52.41 | 12.68 | 76 | 43221 | 302072 | 64153363 |
Suicidal ideation | 51.50 | 12.68 | 128 | 43169 | 66414 | 64389021 |
Pulmonary oedema | 51.35 | 12.68 | 142 | 43155 | 78532 | 64376903 |
Synovitis | 51.32 | 12.68 | 4 | 43293 | 99086 | 64356349 |
Arthralgia | 51.18 | 12.68 | 141 | 43156 | 442119 | 64013316 |
Joint swelling | 50.79 | 12.68 | 42 | 43255 | 215340 | 64240095 |
Sarcopenia | 50.60 | 12.68 | 16 | 43281 | 361 | 64455074 |
Intentional removal of drug delivery system by patient | 50.46 | 12.68 | 8 | 43289 | 0 | 64455435 |
Substance dependence | 50.40 | 12.68 | 17 | 43280 | 473 | 64454962 |
Stress cardiomyopathy | 50.32 | 12.68 | 45 | 43252 | 9212 | 64446223 |
Dysarthria | 49.96 | 12.68 | 118 | 43179 | 59288 | 64396147 |
Fatigue | 49.86 | 12.68 | 297 | 43000 | 748433 | 63707002 |
Injection site necrosis | 49.48 | 12.68 | 22 | 43275 | 1303 | 64454132 |
Therapeutic product effect increased | 49.24 | 12.68 | 22 | 43275 | 1318 | 64454117 |
Dermo-hypodermitis | 48.75 | 12.68 | 17 | 43280 | 524 | 64454911 |
Platelet count decreased | 48.56 | 12.68 | 26 | 43271 | 167685 | 64287750 |
Poisoning | 47.90 | 12.68 | 66 | 43231 | 21813 | 64433622 |
Taste disorder | 47.64 | 12.68 | 44 | 43253 | 9389 | 64446046 |
Blepharospasm | 47.21 | 12.68 | 29 | 43268 | 3346 | 64452089 |
Drug screen negative | 46.44 | 12.68 | 14 | 43283 | 268 | 64455167 |
White blood cell count decreased | 46.39 | 12.68 | 24 | 43273 | 157813 | 64297622 |
Sinusitis | 46.25 | 12.68 | 20 | 43277 | 145908 | 64309527 |
Restlessness | 46.09 | 12.68 | 90 | 43207 | 39695 | 64415740 |
Unresponsive to stimuli | 45.57 | 12.68 | 103 | 43194 | 50290 | 64405145 |
Application site odour | 44.56 | 12.68 | 9 | 43288 | 26 | 64455409 |
Pneumonia | 44.43 | 12.68 | 209 | 43088 | 559367 | 63896068 |
Neutropenia | 43.82 | 12.68 | 58 | 43239 | 239566 | 64215869 |
Injection site extravasation | 43.35 | 12.68 | 39 | 43258 | 8047 | 64447388 |
Injection site erosion | 42.99 | 12.68 | 11 | 43286 | 111 | 64455324 |
Endocarditis | 42.13 | 12.68 | 41 | 43256 | 9337 | 64446098 |
Treatment failure | 42.10 | 12.68 | 13 | 43284 | 116803 | 64338632 |
Incorrect route of product administration | 41.85 | 12.68 | 64 | 43233 | 23234 | 64432201 |
Product physical consistency issue | 41.70 | 12.68 | 15 | 43282 | 507 | 64454928 |
Product dose omission issue | 40.01 | 12.68 | 43 | 43254 | 194704 | 64260731 |
Impaired reasoning | 39.81 | 12.68 | 10 | 43287 | 93 | 64455342 |
Decreased gait velocity | 39.76 | 12.68 | 11 | 43286 | 153 | 64455282 |
Application site inflammation | 39.59 | 12.68 | 14 | 43283 | 450 | 64454985 |
Bradycardia foetal | 39.25 | 12.68 | 10 | 43287 | 99 | 64455336 |
Haemoglobin decreased | 39.05 | 12.68 | 44 | 43253 | 195019 | 64260416 |
Impaired driving ability | 38.75 | 12.68 | 29 | 43268 | 4625 | 64450810 |
Subchondral insufficiency fracture | 38.74 | 12.68 | 9 | 43288 | 58 | 64455377 |
Yawning | 38.50 | 12.68 | 18 | 43279 | 1198 | 64454237 |
Application site dermatitis | 38.45 | 12.68 | 11 | 43286 | 174 | 64455261 |
17 ketosteroids urine abnormal | 37.84 | 12.68 | 6 | 43291 | 0 | 64455435 |
Infection | 37.78 | 12.68 | 41 | 43256 | 184839 | 64270596 |
Congenital multiplex arthrogryposis | 37.55 | 12.68 | 7 | 43290 | 11 | 64455424 |
Deafness neurosensory | 36.67 | 12.68 | 32 | 43265 | 6342 | 64449093 |
Delirium | 36.67 | 12.68 | 116 | 43181 | 69078 | 64386357 |
Exposure during pregnancy | 35.62 | 12.68 | 124 | 43173 | 77551 | 64377884 |
Systemic lupus erythematosus | 35.41 | 12.68 | 5 | 43292 | 77607 | 64377828 |
Breakthrough pain | 35.38 | 12.68 | 17 | 43280 | 1203 | 64454232 |
Rheumatoid arthritis | 35.18 | 12.68 | 35 | 43262 | 164259 | 64291176 |
Confusional state | 35.06 | 12.68 | 297 | 43000 | 260847 | 64194588 |
Bradyphrenia | 34.75 | 12.68 | 37 | 43260 | 9369 | 64446066 |
Aptyalism | 33.63 | 12.68 | 14 | 43283 | 705 | 64454730 |
Anaemia | 33.30 | 12.68 | 136 | 43161 | 378544 | 64076891 |
Interstitial lung disease | 33.25 | 12.68 | 12 | 43285 | 97720 | 64357715 |
Application site pustules | 32.71 | 12.68 | 7 | 43290 | 29 | 64455406 |
Product substitution issue | 31.99 | 12.68 | 49 | 43248 | 17812 | 64437623 |
Injection site cellulitis | 31.84 | 12.68 | 17 | 43280 | 1504 | 64453931 |
Poisoning deliberate | 31.59 | 12.68 | 42 | 43255 | 13416 | 64442019 |
Altered state of consciousness | 31.55 | 12.68 | 75 | 43222 | 37827 | 64417608 |
Vestibular ischaemia | 30.63 | 12.68 | 6 | 43291 | 14 | 64455421 |
Product dispensing issue | 30.55 | 12.68 | 8 | 43289 | 89 | 64455346 |
Dyspnoea | 30.55 | 12.68 | 322 | 42975 | 718352 | 63737083 |
Glomerulonephritis acute | 30.32 | 12.68 | 9 | 43288 | 163 | 64455272 |
Application site hypersensitivity | 29.65 | 12.68 | 10 | 43287 | 278 | 64455157 |
Injection site discharge | 29.11 | 12.68 | 11 | 43286 | 428 | 64455007 |
Hypertension | 28.94 | 12.68 | 84 | 43213 | 259177 | 64196258 |
Cerebrovascular accident | 28.67 | 12.68 | 30 | 43267 | 137553 | 64317882 |
Mucosal inflammation | 28.62 | 12.68 | 4 | 43293 | 62580 | 64392855 |
Housebound | 28.50 | 12.68 | 11 | 43286 | 454 | 64454981 |
Herpes zoster | 28.20 | 12.68 | 9 | 43288 | 79178 | 64376257 |
Ear deformity acquired | 28.07 | 12.68 | 5 | 43292 | 5 | 64455430 |
Nasopharyngitis | 27.83 | 12.68 | 56 | 43241 | 196017 | 64259418 |
Cardiac failure congestive | 27.74 | 12.68 | 28 | 43269 | 130552 | 64324883 |
Weight increased | 27.74 | 12.68 | 64 | 43233 | 213284 | 64242151 |
Glossodynia | 27.64 | 12.68 | 5 | 43292 | 64691 | 64390744 |
Alopecia | 27.41 | 12.68 | 43 | 43254 | 165647 | 64289788 |
Dermatitis contact | 27.40 | 12.68 | 32 | 43265 | 8968 | 64446467 |
Congestive hepatopathy | 27.09 | 12.68 | 22 | 43275 | 3951 | 64451484 |
Swelling | 27.06 | 12.68 | 41 | 43256 | 160177 | 64295258 |
Faecaloma | 27 | 12.68 | 33 | 43264 | 9695 | 64445740 |
Thrombocytopenia | 26.85 | 12.68 | 70 | 43227 | 223731 | 64231704 |
Off label use | 26.68 | 12.68 | 284 | 43013 | 632522 | 63822913 |
Product packaging quantity issue | 26.63 | 12.68 | 13 | 43284 | 953 | 64454482 |
Sedation | 26.22 | 12.68 | 74 | 43223 | 41388 | 64414047 |
Accidental death | 26.19 | 12.68 | 21 | 43276 | 3704 | 64451731 |
Eyelid retraction | 26.19 | 12.68 | 6 | 43291 | 36 | 64455399 |
Feeling drunk | 26.17 | 12.68 | 22 | 43275 | 4145 | 64451290 |
Psychomotor skills impaired | 25.61 | 12.68 | 21 | 43276 | 3824 | 64451611 |
Defaecation disorder | 25.02 | 12.68 | 10 | 43287 | 453 | 64454982 |
Troponin T increased | 24.98 | 12.68 | 17 | 43280 | 2336 | 64453099 |
Rash | 24.88 | 12.68 | 193 | 43104 | 458356 | 63997079 |
Micrognathia | 24.87 | 12.68 | 5 | 43292 | 14 | 64455421 |
Gastrointestinal disorder | 24.40 | 12.68 | 15 | 43282 | 89694 | 64365741 |
Disease progression | 24.17 | 12.68 | 36 | 43261 | 141644 | 64313791 |
Paranoia | 24.02 | 12.68 | 41 | 43256 | 16311 | 64439124 |
Aspartate aminotransferase increased | 23.98 | 12.68 | 27 | 43270 | 119761 | 64335674 |
Application site papules | 23.97 | 12.68 | 6 | 43291 | 55 | 64455380 |
Substance use disorder | 23.63 | 12.68 | 9 | 43288 | 358 | 64455077 |
Tachyphrenia | 23.42 | 12.68 | 15 | 43282 | 1861 | 64453574 |
Atrial fibrillation | 23.32 | 12.68 | 50 | 43247 | 171039 | 64284396 |
Chronic actinic dermatitis | 23.31 | 12.68 | 5 | 43292 | 21 | 64455414 |
Asthenia | 23.29 | 12.68 | 180 | 43117 | 427864 | 64027571 |
Application site induration | 22.99 | 12.68 | 4 | 43293 | 3 | 64455432 |
Congenital coronary artery malformation | 22.98 | 12.68 | 6 | 43291 | 66 | 64455369 |
Pain in extremity | 22.94 | 12.68 | 115 | 43182 | 302970 | 64152465 |
Product preparation error | 22.83 | 12.68 | 20 | 43277 | 3985 | 64451450 |
Vulvar basal cell carcinoma | 22.59 | 12.68 | 5 | 43292 | 25 | 64455410 |
Suicide attempt | 22.54 | 12.68 | 101 | 43196 | 70906 | 64384529 |
Maternal use of illicit drugs | 21.57 | 12.68 | 4 | 43293 | 6 | 64455429 |
Premature delivery | 21.46 | 12.68 | 42 | 43255 | 18547 | 64436888 |
Abnormal behaviour | 21.25 | 12.68 | 60 | 43237 | 33562 | 64421873 |
Prescription drug used without a prescription | 21.20 | 12.68 | 16 | 43281 | 2584 | 64452851 |
Hallucination, visual | 20.96 | 12.68 | 53 | 43244 | 27781 | 64427654 |
Emotional poverty | 20.93 | 12.68 | 10 | 43287 | 699 | 64454736 |
Therapy non-responder | 20.92 | 12.68 | 9 | 43288 | 65890 | 64389545 |
Foetal exposure during pregnancy | 20.92 | 12.68 | 20 | 43277 | 4456 | 64450979 |
Contraindicated product administered | 20.83 | 12.68 | 25 | 43272 | 107804 | 64347631 |
Cyanosis | 20.82 | 12.68 | 46 | 43251 | 22109 | 64433326 |
Therapy naive | 20.80 | 12.68 | 5 | 43292 | 38 | 64455397 |
Mydriasis | 20.68 | 12.68 | 37 | 43260 | 15275 | 64440160 |
Substance abuser | 20.41 | 12.68 | 6 | 43291 | 105 | 64455330 |
Injection site inflammation | 20.22 | 12.68 | 17 | 43280 | 3204 | 64452231 |
Bronchitis | 20.18 | 12.68 | 26 | 43271 | 108717 | 64346718 |
Vomiting | 20.16 | 12.68 | 498 | 42799 | 550619 | 63904816 |
Neuropathy peripheral | 19.91 | 12.68 | 30 | 43267 | 117495 | 64337940 |
Pleural effusion | 19.85 | 12.68 | 34 | 43263 | 126525 | 64328910 |
Cataract | 19.78 | 12.68 | 5 | 43292 | 51257 | 64404178 |
Blood glucose increased | 19.74 | 12.68 | 22 | 43275 | 98051 | 64357384 |
Coronary artery disease | 19.59 | 12.68 | 8 | 43289 | 60425 | 64395010 |
Neurosis | 19.58 | 12.68 | 8 | 43289 | 384 | 64455051 |
Hypersensitivity | 19.55 | 12.68 | 67 | 43230 | 196385 | 64259050 |
Neutrophil count decreased | 19.52 | 12.68 | 14 | 43283 | 77182 | 64378253 |
Lack of application site rotation | 19.45 | 12.68 | 4 | 43293 | 13 | 64455422 |
Epilepsy | 19.42 | 12.68 | 58 | 43239 | 33473 | 64421962 |
Hypoventilation | 19.37 | 12.68 | 22 | 43275 | 5984 | 64449451 |
Application site bruise | 19.31 | 12.68 | 7 | 43290 | 242 | 64455193 |
Victim of sexual abuse | 19.29 | 12.68 | 8 | 43289 | 399 | 64455036 |
Nasal congestion | 19.17 | 12.68 | 8 | 43289 | 59650 | 64395785 |
Abortion spontaneous | 19.06 | 12.68 | 48 | 43249 | 25095 | 64430340 |
Respiratory rate decreased | 19.00 | 12.68 | 19 | 43278 | 4472 | 64450963 |
Foetal non-stress test abnormal | 18.92 | 12.68 | 3 | 43294 | 0 | 64455435 |
Substance use | 18.81 | 12.68 | 9 | 43288 | 631 | 64454804 |
Brief psychotic disorder with marked stressors | 18.73 | 12.68 | 7 | 43290 | 264 | 64455171 |
Vestibular disorder | 18.45 | 12.68 | 14 | 43283 | 2279 | 64453156 |
Injection site erythema | 18.35 | 12.68 | 95 | 43202 | 70705 | 64384730 |
Venous thrombosis | 18.29 | 12.68 | 22 | 43275 | 6359 | 64449076 |
Radial nerve palsy | 18.28 | 12.68 | 8 | 43289 | 456 | 64454979 |
Injection site ischaemia | 18.24 | 12.68 | 4 | 43293 | 19 | 64455416 |
Cryoglobulinaemia | 18.17 | 12.68 | 9 | 43288 | 681 | 64454754 |
Haematocrit decreased | 18.10 | 12.68 | 7 | 43290 | 54648 | 64400787 |
Haemorrhage | 18.04 | 12.68 | 16 | 43281 | 79335 | 64376100 |
Mastication disorder | 17.99 | 12.68 | 14 | 43283 | 2365 | 64453070 |
Incoherent | 17.93 | 12.68 | 23 | 43274 | 7095 | 64448340 |
Allodynia | 17.88 | 12.68 | 11 | 43286 | 1272 | 64454163 |
Pancytopenia | 17.81 | 12.68 | 44 | 43253 | 143265 | 64312170 |
Hepatic enzyme increased | 17.68 | 12.68 | 38 | 43259 | 129905 | 64325530 |
Epistaxis | 17.66 | 12.68 | 24 | 43273 | 98107 | 64357328 |
Abdominal discomfort | 17.59 | 12.68 | 63 | 43234 | 182259 | 64273176 |
Intervertebral discitis | 17.58 | 12.68 | 17 | 43280 | 3840 | 64451595 |
Pulmonary congestion | 17.49 | 12.68 | 45 | 43252 | 23835 | 64431600 |
Persistent depressive disorder | 17.45 | 12.68 | 10 | 43287 | 1016 | 64454419 |
Influenza | 17.28 | 12.68 | 28 | 43269 | 106503 | 64348932 |
Blood cholesterol increased | 17.28 | 12.68 | 6 | 43291 | 50060 | 64405375 |
Application site infection | 17.25 | 12.68 | 5 | 43292 | 83 | 64455352 |
Hypotension | 17.24 | 12.68 | 168 | 43129 | 380806 | 64074629 |
Chronic hepatitis C | 17.07 | 12.68 | 8 | 43289 | 535 | 64454900 |
Judgement impaired | 17.03 | 12.68 | 10 | 43287 | 1063 | 64454372 |
Reaction to excipient | 16.98 | 12.68 | 11 | 43286 | 1392 | 64454043 |
Administration site abscess sterile | 16.84 | 12.68 | 3 | 43294 | 3 | 64455432 |
Hypertonia | 16.82 | 12.68 | 21 | 43276 | 6304 | 64449131 |
Accidental exposure to product | 16.61 | 12.68 | 47 | 43250 | 26317 | 64429118 |
Chest discomfort | 16.60 | 12.68 | 33 | 43264 | 116073 | 64339362 |
Tooth hypoplasia | 16.46 | 12.68 | 6 | 43291 | 211 | 64455224 |
Product odour abnormal | 16.36 | 12.68 | 10 | 43287 | 1143 | 64454292 |
COVID-19 | 16.22 | 12.68 | 12 | 43285 | 65128 | 64390307 |
Malignant neoplasm progression | 16.21 | 12.68 | 32 | 43265 | 112839 | 64342596 |
Upper respiratory tract infection | 16.16 | 12.68 | 15 | 43282 | 72770 | 64382665 |
Constipation | 15.95 | 12.68 | 229 | 43068 | 229108 | 64226327 |
Hallucinations, mixed | 15.94 | 12.68 | 20 | 43277 | 6032 | 64449403 |
Blood creatinine increased | 15.87 | 12.68 | 43 | 43254 | 135739 | 64319696 |
Alcohol interaction | 15.71 | 12.68 | 17 | 43280 | 4384 | 64451051 |
Lactic acidosis | 15.70 | 12.68 | 11 | 43286 | 61399 | 64394036 |
Wrong dose | 15.69 | 12.68 | 10 | 43287 | 1231 | 64454204 |
Psoriasis | 15.66 | 12.68 | 15 | 43282 | 71688 | 64383747 |
Victim of crime | 15.66 | 12.68 | 7 | 43290 | 420 | 64455015 |
Cystic lymphangioma | 15.63 | 12.68 | 3 | 43294 | 6 | 64455429 |
Genitourinary symptom | 15.44 | 12.68 | 6 | 43291 | 252 | 64455183 |
Musculoskeletal stiffness | 15.18 | 12.68 | 38 | 43259 | 123168 | 64332267 |
Oral administration complication | 15.14 | 12.68 | 5 | 43292 | 130 | 64455305 |
Urinary incontinence | 15.11 | 12.68 | 56 | 43241 | 36095 | 64419340 |
Hyperkalaemia | 15.11 | 12.68 | 28 | 43269 | 101101 | 64354334 |
Dementia with Lewy bodies | 15.07 | 12.68 | 8 | 43289 | 699 | 64454736 |
Clostridium difficile infection | 15.01 | 12.68 | 3 | 43294 | 36160 | 64419275 |
Pneumonia aspiration | 14.99 | 12.68 | 79 | 43218 | 59192 | 64396243 |
Road traffic accident | 14.89 | 12.68 | 50 | 43247 | 30695 | 64424740 |
Dependence | 14.84 | 12.68 | 12 | 43285 | 2143 | 64453292 |
Urticaria | 14.82 | 12.68 | 50 | 43247 | 147267 | 64308168 |
Persecutory delusion | 14.73 | 12.68 | 16 | 43281 | 4142 | 64451293 |
Testicular pain | 14.73 | 12.68 | 11 | 43286 | 1749 | 64453686 |
Bruxism | 14.72 | 12.68 | 15 | 43282 | 3609 | 64451826 |
Embolia cutis medicamentosa | 14.67 | 12.68 | 7 | 43290 | 488 | 64454947 |
Repetitive strain injury | 14.59 | 12.68 | 5 | 43292 | 146 | 64455289 |
Electrocardiogram T wave alternans | 14.57 | 12.68 | 4 | 43293 | 54 | 64455381 |
Echocardiogram abnormal | 14.57 | 12.68 | 11 | 43286 | 1778 | 64453657 |
Product contamination | 14.48 | 12.68 | 9 | 43288 | 1060 | 64454375 |
Diabetes mellitus | 14.41 | 12.68 | 14 | 43283 | 66460 | 64388975 |
Injection site oedema | 14.40 | 12.68 | 9 | 43288 | 1071 | 64454364 |
Dyspnoea exertional | 14.34 | 12.68 | 17 | 43280 | 73713 | 64381722 |
Myocardial infarction | 14.26 | 12.68 | 60 | 43237 | 165761 | 64289674 |
Injection site irritation | 14.25 | 12.68 | 14 | 43283 | 3226 | 64452209 |
Ankyloglossia congenital | 14.10 | 12.68 | 3 | 43294 | 12 | 64455423 |
Adjacent segment degeneration | 14.10 | 12.68 | 3 | 43294 | 12 | 64455423 |
Reversible cerebral vasoconstriction syndrome | 13.96 | 12.68 | 12 | 43285 | 2330 | 64453105 |
Developmental hip dysplasia | 13.96 | 12.68 | 5 | 43292 | 167 | 64455268 |
Anxiety | 13.95 | 12.68 | 202 | 43095 | 202447 | 64252988 |
Sepsis | 13.88 | 12.68 | 94 | 43203 | 230247 | 64225188 |
Discoloured vomit | 13.83 | 12.68 | 9 | 43288 | 1148 | 64454287 |
Oropharyngeal pain | 13.82 | 12.68 | 24 | 43273 | 88843 | 64366592 |
Type 2 diabetes mellitus | 13.75 | 12.68 | 3 | 43294 | 34017 | 64421418 |
Dermal absorption impaired | 13.73 | 12.68 | 3 | 43294 | 14 | 64455421 |
Placental disorder | 13.52 | 12.68 | 8 | 43289 | 862 | 64454573 |
Cachexia | 13.39 | 12.68 | 23 | 43274 | 9194 | 64446241 |
Maternal drugs affecting foetus | 13.28 | 12.68 | 10 | 43287 | 1610 | 64453825 |
Delusion | 13.25 | 12.68 | 34 | 43263 | 17980 | 64437455 |
Tricuspid valve replacement | 13.24 | 12.68 | 3 | 43294 | 17 | 64455418 |
Lividity | 13.14 | 12.68 | 6 | 43291 | 378 | 64455057 |
Mental status changes | 13.12 | 12.68 | 13 | 43284 | 61149 | 64394286 |
Productive cough | 13.07 | 12.68 | 18 | 43279 | 73185 | 64382250 |
Pericardial effusion | 13.05 | 12.68 | 5 | 43292 | 39249 | 64416186 |
Product colour issue | 13.04 | 12.68 | 7 | 43290 | 626 | 64454809 |
Throat irritation | 12.99 | 12.68 | 3 | 43294 | 32708 | 64422727 |
Cardiogenic shock | 12.83 | 12.68 | 3 | 43294 | 32424 | 64423011 |
Blood pressure decreased | 12.76 | 12.68 | 24 | 43273 | 86175 | 64369260 |
Injection site vesicles | 12.73 | 12.68 | 12 | 43285 | 2628 | 64452807 |
MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
---|---|---|---|---|---|---|
Drug withdrawal syndrome neonatal | 59.05 | 31.76 | 43 | 160 | 2010 | 82465 |
Poor feeding infant | 39.95 | 31.76 | 13 | 190 | 84 | 84391 |
Source | Code | Description |
---|---|---|
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 | narcotic analgesic |
CHEBI has role | CHEBI:55322 | mu-opioid agonists |
CHEBI has role | CHEBI:59283 | delta-opioid antagonists |
CHEBI has role | CHEBI:167165 | kappa-opioid receptor antagonists |
MeSH PA | D000700 | Analgesics |
MeSH PA | D000701 | Analgesics, Opioid |
MeSH PA | D002491 | Central Nervous System Agents |
MeSH PA | D002492 | Central Nervous System Depressants |
MeSH PA | D009292 | Narcotic Antagonists |
MeSH PA | D009294 | Narcotics |
MeSH PA | D018373 | Peripheral Nervous System Agents |
MeSH PA | D018689 | Sensory System Agents |
FDA MoA | N0000175685 | Partial Opioid Agonists |
FDA EPC | N0000175689 | Partial Opioid Agonist |
CHEBI has role | CHEBI:59282 | kappa-opioid receptor agonists |
Disease | Relation | SNOMED_ID | DOID |
---|---|---|---|
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 |
Species | Use | Relation |
---|---|---|
Cats | Postoperative pain associated with surgical procedures | Indication |
Product | Applicant | Ingredients |
---|---|---|
Simbadol | Zoetis Inc. | 1 |
Zorbium | Elanco US Inc. | 1 |
Dissociation level | Dissociation constant | Type (acidic/basic) |
---|---|---|
pKa1 | 9.97 | acidic |
pKa2 | 8.88 | Basic |
Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Patent number | Patent expiration date | Patent use |
---|---|---|---|---|---|---|---|---|---|---|
EQ 12MG BASE;EQ 3MG BASE | SUBOXONE | INDIVIOR INC | N022410 | Aug. 10, 2012 | RX | FILM | BUCCAL, SUBLINGUAL | 8603514 | April 3, 2024 | TREATMENT OF OPIOID DEPENDENCE/SUBLINGUAL OR BUCCAL APPLICATION |
EQ 2MG BASE;EQ 0.5MG BASE | SUBOXONE | INDIVIOR INC | N022410 | Aug. 30, 2010 | RX | FILM | BUCCAL, SUBLINGUAL | 8603514 | April 3, 2024 | TREATMENT OF OPIOID DEPENDENCE/SUBLINGUAL OR BUCCAL APPLICATION |
EQ 4MG BASE;EQ 1MG BASE | SUBOXONE | INDIVIOR INC | N022410 | Aug. 10, 2012 | RX | FILM | BUCCAL, SUBLINGUAL | 8603514 | April 3, 2024 | TREATMENT OF OPIOID DEPENDENCE/SUBLINGUAL OR BUCCAL APPLICATION |
EQ 8MG BASE;EQ 2MG BASE | SUBOXONE | INDIVIOR INC | N022410 | Aug. 30, 2010 | RX | FILM | BUCCAL, SUBLINGUAL | 8603514 | April 3, 2024 | TREATMENT OF OPIOID DEPENDENCE/SUBLINGUAL OR BUCCAL APPLICATION |
EQ 80MG BASE/IMPLANT | PROBUPHINE | TITAN PHARMS | N204442 | May 26, 2016 | DISCN | IMPLANT | IMPLANTATION | 7736665 | April 25, 2024 | FOR OPIOID DEPENDENCE |
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 | TREATEMENT 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 | TREATEMENT 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 | TREATEMENT 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 | TREATEMENT 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 | TREATEMENT 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 | TREATEMENT 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 | TREATEMENT 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 | OREXO US INC | 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 | OREXO US INC | 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 | OREXO US INC | 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 | OREXO US INC | 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 | OREXO US INC | 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 | OREXO US INC | 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 INC | N022410 | Aug. 10, 2012 | RX | FILM | BUCCAL, SUBLINGUAL | 11135216 | Aug. 7, 2029 | TREATING OPIOID USE DISORDER |
EQ 12MG BASE;EQ 3MG BASE | SUBOXONE | INDIVIOR INC | 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 INC | 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 INC | 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 INC | N022410 | Aug. 10, 2012 | RX | FILM | BUCCAL, SUBLINGUAL | 11135216 | Aug. 7, 2029 | TREATING OPIOID USE DISORDER |
EQ 4MG BASE;EQ 1MG BASE | SUBOXONE | INDIVIOR INC | 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 INC | N022410 | Aug. 30, 2010 | RX | FILM | BUCCAL, SUBLINGUAL | 11135216 | Aug. 7, 2029 | TREATING OPIOID USE DISORDER |
EQ 8MG BASE;EQ 2MG BASE | SUBOXONE | INDIVIOR INC | 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 INC | 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 INC | 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 INC | 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 INC | 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 | OREXO US INC | 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 | OREXO US INC | 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 | OREXO US INC | 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 | OREXO US INC | 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 | OREXO US INC | 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 | OREXO US INC | 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 INC | 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 INC | 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 INC | 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 INC | 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 INC | 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 INC | 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 INC | 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 INC | 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 INC | 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 INC | 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 INC | 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 INC | 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 INC | 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 INC | 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 INC | 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 INC | 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 INC | 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 INC | 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 INC | 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 INC | 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 INC | 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 INC | 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 INC | 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 INC | 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 INC | 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 INC | 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 INC | 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 INC | 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 INC | 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 INC | 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 INC | 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 INC | 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 INC | 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 INC | 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 INC | 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 INC | 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 INC | 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 INC | 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 INC | 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 INC | N209819 | Nov. 30, 2017 | RX | SOLUTION, EXTENDED RELEASE | SUBCUTANEOUS | 8921387 | Jan. 6, 2032 | TREATING OPIOID DEPENDENCY BY ADMINISTERING BUPRENORPHINE ONCE PER MONTH |
EQ 0.7MG BASE;EQ 0.18MG BASE | ZUBSOLV | OREXO US INC | 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 | OREXO US INC | N204242 | July 3, 2013 | RX | TABLET | SUBLINGUAL | 11020388 | Sept. 18, 2032 | USE OF ZUBSOLV FOR TREATMENT OF OPIOID DEPENDENCE |
EQ 11.4MG BASE;EQ 2.9MG BASE | ZUBSOLV | OREXO US INC | 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 | OREXO US INC | N204242 | Dec. 11, 2014 | RX | TABLET | SUBLINGUAL | 11020388 | Sept. 18, 2032 | USE OF ZUBSOLV FOR TREATMENT OF OPIOID DEPENDENCE |
EQ 2.9MG BASE;EQ 0.71MG BASE | ZUBSOLV | OREXO US INC | 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 | OREXO US INC | N204242 | June 4, 2015 | RX | TABLET | SUBLINGUAL | 11020388 | Sept. 18, 2032 | USE OF ZUBSOLV FOR TREATMENT OF OPIOID DEPENDENCE |
EQ 5.7MG BASE;EQ 1.4MG BASE | ZUBSOLV | OREXO US INC | 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 | OREXO US INC | N204242 | July 3, 2013 | RX | TABLET | SUBLINGUAL | 11020388 | Sept. 18, 2032 | USE OF ZUBSOLV FOR TREATMENT OF OPIOID DEPENDENCE |
EQ 8.6MG BASE;EQ 2.1MG BASE | ZUBSOLV | OREXO US INC | 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 | OREXO US INC | N204242 | Dec. 11, 2014 | RX | TABLET | SUBLINGUAL | 11020388 | 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 INC | N209819 | Nov. 30, 2017 | RX | SOLUTION, EXTENDED RELEASE | SUBCUTANEOUS | 11000520 | Nov. 6, 2035 | TREATING OPIOID USE DISORDER |
300MG/1.5ML (200MG/ML) | SUBLOCADE | INDIVIOR INC | N209819 | Nov. 30, 2017 | RX | SOLUTION, EXTENDED RELEASE | SUBCUTANEOUS | 11000520 | Nov. 6, 2035 | TREATING OPIOID USE DISORDER |
300MG/1.5ML (200MG/ML) | SUBLOCADE | INDIVIOR INC | N209819 | Nov. 30, 2017 | RX | SOLUTION, EXTENDED RELEASE | SUBCUTANEOUS | 10646484 | June 22, 2038 | TREATMENT OF MODERATE TO SEVERE OPIOID USE DISORDER |
None
Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA 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 |
ID | Source |
---|---|
4019644 | VUID |
N0000147737 | NUI |
D00836 | KEGG_DRUG |
53152-21-9 | SECONDARY_CAS_RN |
1819 | RXNORM |
C0006405 | UMLSCUI |
CHEBI:3216 | CHEBI |
CHEMBL560511 | ChEMBL_ID |
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 |
001573 | NDDF |
004632 | NDDF |
21066009 | SNOMEDCT_US |
31684002 | SNOMEDCT_US |
387173000 | SNOMEDCT_US |
4018880 | VANDF |
4019644 | VANDF |
Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
---|---|---|---|---|---|---|---|---|
Buprenorphine HCl | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0054-0176 | TABLET | 2 mg | SUBLINGUAL | ANDA | 33 sections |
Buprenorphine HCl | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0054-0176 | TABLET | 2 mg | SUBLINGUAL | ANDA | 33 sections |
Buprenorphine HCl | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0054-0177 | TABLET | 8 mg | SUBLINGUAL | ANDA | 33 sections |
Buprenorphine HCl | 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 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 | 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 | 0228-3154 | 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 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 | 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 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 |
Buprenorphine Hydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0409-2012 | INJECTION, SOLUTION | 0.30 mg | INTRAMUSCULAR | ANDA | 31 sections |
Buprenorphine Hydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0517-0725 | INJECTION, SOLUTION | 0.32 mg | INTRAMUSCULAR | ANDA | 21 sections |