morphine Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
opioid receptor antagonists/agonists, morphinan derivates 1845 57-27-2

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • morphine hydrochloride
  • morphine
  • morphin
  • morphina
  • morphine sulfate
  • morphine liposomal
  • morphine sulfate hydrate
  • morphine HCl
The principal alkaloid in opium and the prototype opiate analgesic and narcotic. Morphine has widespread effects in the central nervous system and on smooth muscle.
  • Molecular weight: 285.34
  • Formula: C17H19NO3
  • CLOGP: 0.57
  • LIPINSKI: 0
  • HAC: 4
  • HDO: 2
  • TPSA: 52.93
  • ALOGS: -1.45
  • ROTB: 0

  • Status: OFP

  • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
0.10 g O
30 mg P
30 mg R

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 1 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 57.14 mg/mL Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 4 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 5.85 ┬ÁM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 24 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution) 2.30 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 26 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.65 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 2 hours Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
None FDA

FDA Adverse Event Reporting System (Female)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Drug hypersensitivity 21104.06 27.76 4964 7201 41679 2304241
Drug abuse 3069.37 27.76 844 11321 11182 2334738
Toxicity to various agents 3020.46 27.76 1051 11114 31703 2314217
Completed suicide 1991.49 27.76 691 11474 20343 2325577
Death 1204.18 27.76 733 11432 80735 2265185
Overdose 1184.76 27.76 466 11699 19441 2326479
Respiratory arrest 1112.68 27.76 332 11833 5846 2340074
Cardio-respiratory arrest 964.72 27.76 327 11838 8819 2337101
Vomiting 938.42 27.76 598 11567 71004 2274916
Cardiac arrest 836.21 27.76 335 11830 14595 2331325
Somnolence 835.80 27.76 382 11783 23103 2322817
Nausea 745.27 27.76 621 11544 111568 2234352
Pruritus 722.05 27.76 423 11742 42917 2303003
Accidental overdose 699.38 27.76 210 11955 3762 2342158
Hypotension 665.23 27.76 363 11802 32073 2313847
Respiratory depression 538.94 27.76 150 12015 2020 2343900
Coma 498.55 27.76 201 11964 8855 2337065
Pain 459.82 27.76 367 11798 61490 2284430
Urticaria 435.12 27.76 249 11916 24012 2321908
Confusional state 431.65 27.76 248 11917 24096 2321824
Depressed level of consciousness 412.29 27.76 167 11998 7437 2338483
Intentional product misuse 405.87 27.76 176 11989 9313 2336607
Exposure during pregnancy 399.86 27.76 239 11926 24980 2320940
Rash 393.23 27.76 330 11835 59228 2286692
Miosis 389.95 27.76 103 12062 1121 2344799
Unresponsive to stimuli 389.39 27.76 142 12023 4734 2341186
Constipation 385.05 27.76 221 11944 21408 2324512
Poisoning 365.36 27.76 118 12047 2702 2343218
Drug ineffective 345.56 27.76 391 11774 101233 2244687
Hallucination 331.67 27.76 146 12019 8002 2337918
Sedation 325.57 27.76 113 12052 3249 2342671
Drug dependence 309.01 27.76 106 12059 2939 2342981
Exposure via ingestion 293.02 27.76 75 12090 713 2345207
Anaphylactic reaction 285.97 27.76 139 12026 9566 2336354
Delirium 280.53 27.76 114 12051 5109 2340811
Drug intolerance 264.99 27.76 148 12017 13569 2332351
Drug withdrawal syndrome 263.96 27.76 118 12047 6703 2339217
Substance abuse 252.73 27.76 62 12103 487 2345433
Hyperaesthesia 250.29 27.76 73 12092 1170 2344750
Mental status changes 249.86 27.76 107 12058 5475 2340445
Drug screen positive 248.60 27.76 68 12097 852 2345068
Oxygen saturation decreased 245.78 27.76 116 12049 7470 2338450
Agitation 240.40 27.76 129 12036 10922 2334998
Myoclonus 238.59 27.76 83 12082 2400 2343520
Loss of consciousness 231.87 27.76 152 12013 18615 2327305
Respiratory rate decreased 215.20 27.76 55 12110 519 2345401
Lethargy 209.96 27.76 109 12056 8621 2337299
Dyspnoea 198.46 27.76 261 11904 78472 2267448
Tachycardia 183.59 27.76 125 12040 16284 2329636
Acute chest syndrome 182.21 27.76 34 12131 49 2345871
Heart rate increased 177.55 27.76 106 12059 10999 2334921
Bradycardia 174.63 27.76 101 12064 9880 2336040
Dilatation intrahepatic duct acquired 173.94 27.76 33 12132 55 2345865
Intestinal pseudo-obstruction 171.34 27.76 35 12130 101 2345819
Medication error 163.20 27.76 82 12083 6049 2339871
Apnoea 162.33 27.76 54 12111 1357 2344563
Drug interaction 160.29 27.76 146 12019 29017 2316903
Contrast media allergy 151.82 27.76 35 12130 203 2345717
Pulmonary oedema 151.82 27.76 83 12082 7280 2338640
Inadequate analgesia 140.11 27.76 40 12125 591 2345329
Blood pressure systolic increased 135.69 27.76 54 12111 2285 2343635
Drug diversion 133.15 27.76 31 12134 189 2345731
Fall 132.28 27.76 165 12000 46934 2298986
Bradypnoea 126.21 27.76 34 12131 400 2345520
Disorientation 123.58 27.76 69 12096 6303 2339617
Drug abuser 123.52 27.76 40 12125 921 2344999
Respiratory failure 123.35 27.76 91 12074 13437 2332483
Acidosis 121.42 27.76 45 12120 1565 2344355
Hypoxia 119.59 27.76 67 12098 6160 2339760
Abdominal pain 115.50 27.76 132 12033 34242 2311678
Blood pressure decreased 114.39 27.76 75 12090 9161 2336759
Intentional overdose 114.26 27.76 81 12084 11240 2334680
Cyanosis 110.18 27.76 51 12114 3134 2342786
Respiratory rate increased 109.20 27.76 41 12124 1479 2344441
Hypertension 107.35 27.76 114 12051 27247 2318673
Accidental death 107.09 27.76 28 12137 291 2345629
Sinus tachycardia 101.97 27.76 49 12116 3276 2342644
Aspiration 101.63 27.76 39 12126 1495 2344425
Headache 98.85 27.76 192 11973 79987 2265933
Urinary retention 97.42 27.76 49 12116 3618 2342302
Abnormal behaviour 96.27 27.76 53 12112 4707 2341213
Restlessness 95.59 27.76 52 12113 4511 2341409
Hallucination, visual 94.70 27.76 45 12120 2934 2342986
Acute kidney injury 94.44 27.76 108 12057 28014 2317906
Pyrexia 93.88 27.76 150 12015 53558 2292362
Back pain 93.75 27.76 114 12051 31545 2314375
Pulmonary congestion 92.28 27.76 39 12126 1926 2343994
Drug tolerance 90.51 27.76 26 12139 393 2345527
Blood pressure increased 89.24 27.76 83 12082 16903 2329017
Malaise 88.71 27.76 149 12016 55436 2290484
Anxiety 85.75 27.76 105 12060 29254 2316666
Hyperhidrosis 84.20 27.76 77 12088 15345 2330575
Asphyxia 82.89 27.76 30 12135 974 2344946
Hypothermia 79.32 27.76 36 12129 2112 2343808
Blood pH decreased 77.89 27.76 24 12141 467 2345453
Rheumatoid arthritis 77.25 27.76 81 12084 19059 2326861
Pneumonia aspiration 76.59 27.76 42 12123 3700 2342220
Pneumonia 74.47 27.76 129 12036 49167 2296753
Pancreatic fibrosis 73.15 27.76 12 12153 2 2345918
Accidental exposure to product by child 72.73 27.76 24 12141 587 2345333
Abdominal discomfort 72.46 27.76 75 12090 17381 2328539
Heart rate decreased 71.78 27.76 40 12125 3636 2342284
Body temperature increased 71.63 27.76 38 12127 3133 2342787
Gait disturbance 71.33 27.76 84 12081 22461 2323459
Maternal exposure during pregnancy 71.15 27.76 69 12096 14794 2331126
Hypercapnia 71.03 27.76 23 12142 529 2345391
Hepatocellular injury 70.77 27.76 41 12124 4014 2341906
Insomnia 70.12 27.76 89 12076 25698 2320222
Aggression 69.52 27.76 43 12122 4743 2341177
Joint swelling 69.34 27.76 72 12093 16747 2329173
Cholestasis 68.62 27.76 39 12126 3682 2342238
Post procedural complication 68.42 27.76 36 12129 2918 2343002
Poisoning deliberate 67.34 27.76 27 12138 1164 2344756
Feeling abnormal 66.68 27.76 83 12082 23498 2322422
Blood pressure diastolic decreased 66.01 27.76 26 12139 1069 2344851
Dehydration 65.49 27.76 80 12085 22215 2323705
Granuloma 64.23 27.76 22 12143 605 2345315
Oliguria 63.94 27.76 27 12138 1330 2344590
Therapy non-responder 63.86 27.76 50 12115 8054 2337866
Faecaloma 63.25 27.76 24 12141 891 2345029
Pupil fixed 62.69 27.76 20 12145 438 2345482
Condition aggravated 62.33 27.76 94 12071 31885 2314035
Hypoventilation 62.26 27.76 22 12143 665 2345255
Swelling 62.08 27.76 67 12098 16283 2329637
Upper respiratory tract infection 62.07 27.76 51 12114 8800 2337120
Respiratory distress 61.90 27.76 41 12124 5088 2340832
Blood urea increased 61.72 27.76 36 12129 3569 2342351
Sedation complication 61.65 27.76 16 12149 161 2345759
Foetal exposure during pregnancy 61.01 27.76 41 12124 5211 2340709
Venoocclusive liver disease 60.99 27.76 21 12144 587 2345333
Cognitive disorder 60.11 27.76 41 12124 5340 2340580
Creatinine renal clearance decreased 59.64 27.76 23 12142 893 2345027
Aspartate aminotransferase increased 59.32 27.76 58 12107 12554 2333366
Therapeutic product effect decreased 59.12 27.76 54 12111 10735 2335185
Abdominal distension 58.80 27.76 53 12112 10358 2335562
Treatment failure 57.77 27.76 45 12120 7194 2338726
Pruritus allergic 57.70 27.76 15 12150 152 2345768
Alanine aminotransferase increased 57.70 27.76 60 12105 13972 2331948
Hepatotoxicity 57.59 27.76 34 12131 3447 2342473
Hepatic steatosis 57.43 27.76 33 12132 3180 2342740
Pulseless electrical activity 57.35 27.76 23 12142 992 2344928
Maternal exposure during delivery 56.84 27.76 15 12150 162 2345758
Visceral congestion 56.76 27.76 12 12153 43 2345877
Myocardial fibrosis 56.49 27.76 14 12151 115 2345805
Systemic mastocytosis 56.33 27.76 12 12153 45 2345875
Central nervous system injury 56.25 27.76 9 12156 0 2345920
Obliterative bronchiolitis 56.24 27.76 16 12149 233 2345687
Spleen congestion 55.72 27.76 12 12153 48 2345872
Pupillary reflex impaired 54.51 27.76 18 12147 441 2345479
Blood potassium increased 54.40 27.76 28 12137 2168 2343752
Foetal heart rate abnormal 54.21 27.76 14 12151 138 2345782
Orthostatic hypotension 52.61 27.76 30 12135 2849 2343071
Body temperature decreased 51.47 27.76 23 12142 1300 2344620
Respiratory acidosis 51.27 27.76 20 12145 801 2345119
Withdrawal syndrome 51.06 27.76 31 12134 3306 2342614
Peripheral nerve injury 50.87 27.76 12 12153 78 2345842
Drug withdrawal syndrome neonatal 50.60 27.76 17 12148 440 2345480
Cardiomegaly 49.32 27.76 27 12138 2369 2343551
Hypoxic-ischaemic encephalopathy 48.90 27.76 19 12146 753 2345167
Posterior reversible encephalopathy syndrome 48.45 27.76 27 12138 2453 2343467
Mydriasis 48.45 27.76 26 12139 2193 2343727
Tremor 47.94 27.76 66 12099 20595 2325325
Implant site extravasation 47.94 27.76 13 12152 157 2345763
Brain oedema 47.47 27.76 26 12139 2284 2343636
Spinal epidural haemorrhage 47.43 27.76 9 12156 15 2345905
Speech disorder 46.90 27.76 38 12127 6426 2339494
Serotonin syndrome 46.88 27.76 30 12135 3510 2342410
Hypersensitivity 46.87 27.76 70 12095 23523 2322397
Aortic valve calcification 46.57 27.76 11 12154 72 2345848
Arthralgia 46.10 27.76 112 12053 54173 2291747
Abdominal hernia 46.05 27.76 17 12148 584 2345336
Live birth 45.66 27.76 21 12144 1270 2344650
Dysarthria 45.62 27.76 37 12128 6265 2339655
Dizziness 45.59 27.76 117 12048 58548 2287372
Asthenia 45.51 27.76 102 12063 46824 2299096
Fatigue 45.40 27.76 148 12017 84725 2261195
Multiple organ dysfunction syndrome 45.32 27.76 40 12125 7601 2338319
Wheezing 45.20 27.76 37 12128 6347 2339573
Blood creatinine increased 45.03 27.76 46 12119 10487 2335433
Narcotic bowel syndrome 44.85 27.76 9 12156 23 2345897
Gallbladder cholesterolosis 44.71 27.76 12 12153 139 2345781
Dry mouth 44.61 27.76 41 12124 8212 2337708
Herpes zoster 44.38 27.76 44 12121 9681 2336239
Patient uncooperative 44.30 27.76 9 12156 25 2345895
Muscle spasms 44.30 27.76 65 12100 21501 2324419
Liver function test abnormal 44.01 27.76 39 12126 7451 2338469
Blood calcium decreased 43.54 27.76 24 12141 2134 2343786
Blood creatine phosphokinase increased 43.32 27.76 33 12132 5103 2340817
Thrombocytopenia 42.72 27.76 60 12105 19071 2326849
Balance disorder 42.46 27.76 43 12122 9704 2336216
Suicide attempt 40.67 27.76 45 12120 11237 2334683
Infusion related reaction 40.47 27.76 42 12123 9754 2336166
Psoriasis 40.46 27.76 55 12110 16953 2328967
Nervous system disorder 40.26 27.76 26 12139 3090 2342830
Stupor 40.23 27.76 16 12149 675 2345245
Toxicologic test abnormal 40.03 27.76 11 12154 140 2345780
Weight decreased 39.87 27.76 72 12093 28299 2317621
PO2 decreased 39.82 27.76 13 12152 307 2345613
Altered state of consciousness 39.79 27.76 28 12137 3832 2342088
Device failure 39.43 27.76 21 12144 1744 2344176
Toxic leukoencephalopathy 39.34 27.76 10 12155 92 2345828
Incoherent 39.13 27.76 17 12148 898 2345022
Cough 39.07 27.76 78 12087 33039 2312881
Retrograde amnesia 39.05 27.76 10 12155 95 2345825
Blood pressure diastolic increased 38.40 27.76 14 12151 464 2345456
Blood potassium decreased 38.09 27.76 31 12134 5274 2340646
Venoocclusive disease 37.90 27.76 12 12153 256 2345664
Haemoglobin decreased 37.69 27.76 55 12110 18096 2327824
Hepatitis fulminant 37.51 27.76 15 12150 642 2345278
Stridor 37.20 27.76 15 12150 656 2345264
Anaphylactic shock 37.16 27.76 28 12137 4258 2341662
Hypotonia 37.01 27.76 20 12145 1710 2344210
Allodynia 37.01 27.76 10 12155 119 2345801
Muscular weakness 36.69 27.76 49 12116 14848 2331072
Dyskinesia 36.54 27.76 29 12136 4760 2341160
Hypoglycaemia 36.45 27.76 37 12128 8370 2337550
General physical health deterioration 35.58 27.76 47 12118 14092 2331828
Blood pressure systolic decreased 35.49 27.76 15 12150 740 2345180
Diarrhoea 35.42 27.76 135 12030 83429 2262491
Self-medication 35.32 27.76 14 12151 585 2345335
Chest pain 35.28 27.76 68 12097 28069 2317851
Hyperchloraemia 35.19 27.76 9 12156 85 2345835
Heat stroke 35.19 27.76 10 12155 145 2345775
Snoring 34.93 27.76 13 12152 457 2345463
Areflexia 34.79 27.76 14 12151 609 2345311
Victim of sexual abuse 34.73 27.76 9 12156 90 2345830
Angioedema 34.68 27.76 36 12129 8360 2337560
Intestinal obstruction 34.37 27.76 27 12138 4366 2341554
Blood glucose increased 34.29 27.76 43 12122 12247 2333673
Erythema 34.27 27.76 63 12102 25096 2320824
Seizure 34.26 27.76 62 12103 24404 2321516
Acute pulmonary oedema 33.90 27.76 17 12148 1246 2344674
Paraplegia 33.75 27.76 13 12152 503 2345417
Rhabdomyolysis 33.72 27.76 32 12133 6672 2339248
Abdominal pain upper 33.51 27.76 58 12107 22042 2323878
Complication associated with device 33.36 27.76 23 12142 3046 2342874
Electrocardiogram QRS complex prolonged 33.05 27.76 16 12149 1086 2344834
Chest discomfort 32.91 27.76 46 12119 14549 2331371
Neuralgia 32.70 27.76 22 12143 2800 2343120
Congenital pulmonary hypertension 32.50 27.76 7 12158 28 2345892
Premature baby 32.47 27.76 23 12142 3181 2342739
Splenic injury 32.30 27.76 7 12158 29 2345891
Acute generalised exanthematous pustulosis 32.25 27.76 18 12147 1640 2344280
Incorrect dose administered 32.09 27.76 37 12128 9658 2336262
Cardiopulmonary failure 32.00 27.76 14 12151 752 2345168
Depression 31.67 27.76 65 12100 28067 2317853
Mendelson's syndrome 31.62 27.76 6 12159 10 2345910
Hypochromasia 31.57 27.76 7 12158 33 2345887
Anterior spinal artery syndrome 30.91 27.76 6 12159 12 2345908
Asthma 30.64 27.76 39 12126 11275 2334645
Symptom masked 30.35 27.76 8 12157 86 2345834
Face oedema 30.32 27.76 24 12141 3924 2341996
Blood pressure fluctuation 30.19 27.76 18 12147 1857 2344063
Brain injury 29.56 27.76 14 12151 905 2345015
Accidental exposure to product 29.09 27.76 33 12132 8464 2337456
Procedural pain 28.86 27.76 17 12148 1715 2344205
Blood alkaline phosphatase increased 28.73 27.76 29 12136 6516 2339404
Stevens-Johnson syndrome 28.72 27.76 24 12141 4235 2341685
Epidural haemorrhage 28.71 27.76 6 12159 20 2345900
White blood cell count increased 28.61 27.76 30 12135 7048 2338872
Dysphagia 28.34 27.76 40 12125 12765 2333155
Drug level increased 28.22 27.76 20 12145 2767 2343153
Large intestine perforation 28.15 27.76 15 12150 1247 2344673
Sleep apnoea syndrome 28.11 27.76 18 12147 2108 2343812
Hypoaesthesia 28.00 27.76 51 12114 20164 2325756
Coma scale abnormal 27.97 27.76 13 12152 805 2345115
Premature delivery 27.95 27.76 21 12144 3179 2342741
Incorrect route of product administration 27.85 27.76 26 12139 5310 2340610
Blood bilirubin increased 27.81 27.76 26 12139 5319 2340601

FDA Adverse Event Reporting System (Male)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Drug hypersensitivity 4527.01 34.81 1233 7346 13902 1724300
Toxicity to various agents 3959.39 34.81 1289 7290 27852 1710350
Drug abuse 3544.34 34.81 999 7580 12690 1725512
Overdose 1811.46 34.81 630 7949 16071 1722131
Completed suicide 1347.18 34.81 504 8075 15808 1722394
Accidental overdose 1134.05 34.81 319 8260 3845 1734357
Death 1112.04 34.81 754 7825 86689 1651513
Respiratory depression 945.82 34.81 243 8336 2004 1736198
Respiratory arrest 832.74 34.81 272 8307 5567 1732635
Somnolence 803.37 34.81 351 8228 16388 1721814
Cardio-respiratory arrest 738.00 34.81 280 8299 9013 1729189
Cardiac arrest 725.12 34.81 322 8257 15608 1722594
Intentional product misuse 669.13 34.81 245 8334 7113 1731089
Confusional state 601.14 34.81 310 8269 20968 1717234
Unresponsive to stimuli 569.00 34.81 193 8386 4436 1733766
Substance abuse 553.95 34.81 135 8444 868 1737334
Mental status changes 521.38 34.81 194 8385 5881 1732321
Sedation 518.15 34.81 167 8412 3250 1734952
Coma 491.21 34.81 195 8384 7067 1731135
Depressed level of consciousness 445.68 34.81 177 8402 6415 1731787
Vomiting 444.06 34.81 315 8264 38000 1700202
Poisoning 417.68 34.81 132 8447 2400 1735802
Pulmonary oedema 414.59 34.81 168 8411 6418 1731784
Hypotension 412.33 34.81 273 8306 29381 1708821
Nausea 387.78 34.81 327 8252 50869 1687333
Lethargy 387.09 34.81 164 8415 7020 1731182
Miosis 377.57 34.81 108 8471 1370 1736832
Drug withdrawal syndrome 375.15 34.81 141 8438 4384 1733818
Drug dependence 374.53 34.81 130 8449 3197 1735005
Agitation 370.22 34.81 181 8398 10845 1727357
Delirium 365.35 34.81 152 8427 6210 1731992
Constipation 347.74 34.81 192 8387 14808 1723394
Drug screen positive 295.96 34.81 83 8496 974 1737228
Oxygen saturation decreased 293.76 34.81 126 8453 5549 1732653
Pain 284.65 34.81 209 8370 26448 1711754
Hyperaesthesia 268.07 34.81 71 8508 660 1737542
Drug interaction 247.30 34.81 196 8383 27762 1710440
Hallucination 246.96 34.81 125 8454 8045 1730157
Loss of consciousness 223.19 34.81 144 8435 14731 1723471
Drug abuser 219.70 34.81 71 8508 1386 1736816
Brain oedema 213.46 34.81 77 8502 2119 1736083
Pneumonia aspiration 190.14 34.81 91 8488 5175 1733027
Accidental death 188.92 34.81 48 8531 372 1737830
Apnoea 183.90 34.81 62 8517 1387 1736815
Pulmonary congestion 181.84 34.81 65 8514 1740 1736462
Respiratory rate decreased 178.99 34.81 46 8533 375 1737827
Acute chest syndrome 172.87 34.81 33 8546 45 1738157
Hypoxia 170.68 34.81 88 8491 5875 1732327
Pruritus 167.90 34.81 145 8434 23077 1715125
Exposure via ingestion 166.00 34.81 48 8531 632 1737570
Drug ineffective 159.75 34.81 228 8351 63573 1674629
Tachycardia 159.73 34.81 110 8469 12518 1725684
Medication error 159.25 34.81 78 8501 4665 1733537
Hyperhidrosis 146.76 34.81 104 8475 12384 1725818
Acute kidney injury 138.20 34.81 157 8422 34787 1703415
Urinary retention 135.57 34.81 73 8506 5322 1732880
Myoclonus 132.07 34.81 55 8524 2240 1735962
Heart rate increased 128.02 34.81 75 8504 6435 1731767
Intentional overdose 126.69 34.81 79 8500 7591 1730611
Inadequate analgesia 123.65 34.81 36 8543 486 1737716
Withdrawal syndrome 122.20 34.81 52 8527 2236 1735966
Asphyxia 120.49 34.81 42 8537 1041 1737161
Aspiration 118.43 34.81 48 8531 1822 1736380
Bradypnoea 115.30 34.81 31 8548 306 1737896
Blood pH decreased 108.44 34.81 32 8547 454 1737748
Hypoventilation 104.71 34.81 32 8547 515 1737687
Acute pulmonary oedema 104.61 34.81 39 8540 1178 1737024
Abdominal pain 103.06 34.81 107 8472 21383 1716819
Aggression 98.55 34.81 69 8510 8046 1730156
Disorientation 94.51 34.81 58 8521 5411 1732791
Respiratory distress 92.47 34.81 56 8523 5101 1733101
Fall 90.44 34.81 112 8467 27102 1711100
Asthenia 89.47 34.81 126 8453 34544 1703658
Dyskinesia 88.50 34.81 49 8530 3770 1734432
Urticaria 87.39 34.81 76 8503 12165 1726037
Muscle spasms 84.68 34.81 73 8506 11548 1726654
Hypogonadism male 84.54 34.81 19 8560 80 1738122
Dysarthria 83.86 34.81 53 8526 5206 1732996
Cyanosis 83.84 34.81 42 8537 2632 1735570
Serotonin syndrome 82.18 34.81 42 8537 2746 1735456
Toxicologic test abnormal 82.01 34.81 20 8559 128 1738074
Hypoxic-ischaemic encephalopathy 81.87 34.81 30 8549 862 1737340
Self-medication 81.86 34.81 28 8551 654 1737548
Cardiomegaly 77.14 34.81 38 8541 2296 1735906
Sinus tachycardia 77.12 34.81 39 8540 2493 1735709
Dyspnoea 76.90 34.81 147 8432 51912 1686290
Blood pressure decreased 76.87 34.81 58 8521 7588 1730614
Restlessness 75.09 34.81 46 8533 4275 1733927
Respiratory failure 74.52 34.81 75 8504 14430 1723772
Back pain 72.99 34.81 79 8500 16534 1721668
Weight decreased 71.34 34.81 91 8488 22662 1715540
Rash 70.81 34.81 120 8459 38573 1699629
Condition aggravated 70.14 34.81 87 8492 21063 1717139
Pancreatitis acute 67.19 34.81 42 8537 4045 1734157
Blood pressure increased 65.36 34.81 61 8518 10692 1727510
Poisoning deliberate 65.18 34.81 25 8554 817 1737385
Bradycardia 64.50 34.81 60 8519 10474 1727728
Respiratory rate increased 64.44 34.81 28 8551 1266 1736936
Pupil fixed 63.04 34.81 20 8559 366 1737836
Intestinal obstruction 62.64 34.81 38 8541 3469 1734733
Sedation complication 62.50 34.81 16 8563 128 1738074
Hallucination, visual 62.08 34.81 34 8545 2558 1735644
Rhabdomyolysis 61.87 34.81 60 8519 11030 1727172
Alcohol poisoning 61.37 34.81 21 8558 491 1737711
Malaise 61.22 34.81 97 8482 29468 1708734
Stupor 60.56 34.81 22 8557 616 1737586
PCO2 increased 60.05 34.81 16 8563 152 1738050
Pneumonia 58.05 34.81 122 8457 46060 1692142
Blood potassium decreased 57.45 34.81 31 8548 2264 1735938
Acidosis 57.42 34.81 27 8552 1470 1736732
Blood pressure diastolic decreased 57.10 34.81 22 8557 728 1737474
Dizziness 56.88 34.81 102 8477 34259 1703943
Anaphylactic reaction 56.23 34.81 44 8535 6069 1732133
Aspartate aminotransferase increased 55.92 34.81 56 8523 10700 1727502
Drug use disorder 55.49 34.81 19 8560 445 1737757
Accident 54.91 34.81 22 8557 809 1737393
Encephalopathy 54.35 34.81 38 8541 4414 1733788
Drug diversion 54.34 34.81 16 8563 225 1737977
Arteriosclerosis coronary artery 54.30 34.81 28 8551 1864 1736338
Mydriasis 54.26 34.81 25 8554 1299 1736903
Feeling abnormal 54.16 34.81 56 8523 11110 1727092
Seizure 53.68 34.81 75 8504 20366 1717836
Therapy non-responder 53.14 34.81 43 8536 6223 1731979
Suicide attempt 50.98 34.81 45 8534 7336 1730866
Brain death 50.48 34.81 18 8561 477 1737725
Accidental exposure to product 50.05 34.81 35 8544 4066 1734136
Tremor 50.03 34.81 58 8521 13073 1725129
Body temperature decreased 49.37 34.81 22 8557 1057 1737145
Electrocardiogram QT prolonged 49.04 34.81 39 8540 5506 1732696
Sphincter of Oddi dysfunction 48.46 34.81 10 8569 25 1738177
Post procedural complication 48.27 34.81 28 8551 2352 1735850
Blood pressure systolic increased 48.26 34.81 25 8554 1680 1736522
Respiratory acidosis 48.19 34.81 19 8560 669 1737533
Incorrect route of product administration 48.05 34.81 32 8547 3433 1734769
Circulatory collapse 48.03 34.81 32 8547 3435 1734767
Decreased appetite 47.57 34.81 77 8502 23794 1714408
Snoring 46.79 34.81 17 8562 476 1737726
Coagulopathy 46.76 34.81 29 8550 2752 1735450
Visceral congestion 46.76 34.81 12 8567 97 1738105
Abnormal behaviour 46.48 34.81 40 8539 6302 1731900
Arteriosclerosis 46.37 34.81 25 8554 1822 1736380
Multiple organ dysfunction syndrome 45.99 34.81 47 8532 9195 1729007
Blood potassium increased 44.11 34.81 27 8552 2503 1735699
Anxiety 43.80 34.81 59 8520 15468 1722734
Secondary hypogonadism 43.65 34.81 11 8568 82 1738120
Cardiac failure 43.60 34.81 53 8526 12549 1725653
Metabolic acidosis 43.56 34.81 36 8543 5366 1732836
Drug tolerance 42.96 34.81 15 8564 373 1737829
Accidental exposure to product by child 42.71 34.81 18 8561 754 1737448
Blood creatine phosphokinase increased 42.19 34.81 44 8535 8812 1729390
Allodynia 42.11 34.81 11 8568 96 1738106
Diarrhoea 41.62 34.81 118 8461 53734 1684468
Pallor 41.36 34.81 29 8550 3382 1734820
Hypercapnia 41.03 34.81 16 8563 547 1737655
Lung cancer metastatic 40.89 34.81 16 8563 552 1737650
Intestinal ischaemia 40.41 34.81 19 8560 1034 1737168
Muscular weakness 40.25 34.81 46 8533 10203 1727999
Pulmonary haemorrhage 39.89 34.81 22 8557 1677 1736525
Device failure 39.38 34.81 17 8562 756 1737446
Dehydration 39.38 34.81 60 8519 17598 1720604
Troponin increased 39.29 34.81 20 8559 1295 1736907
Heart rate decreased 39.08 34.81 26 8553 2783 1735419
Accidental poisoning 38.95 34.81 11 8568 132 1738070
Pupillary reflex impaired 38.77 34.81 14 8565 385 1737817
Hyperkalaemia 38.11 34.81 41 8538 8506 1729696
Sleep apnoea syndrome 37.58 34.81 23 8556 2131 1736071
Muscle spasticity 37.46 34.81 20 8559 1429 1736773
Hyperthermia 37.26 34.81 21 8558 1670 1736532
General physical health deterioration 37.22 34.81 50 8529 13068 1725134
Drug level increased 36.95 34.81 25 8554 2752 1735450
Alanine aminotransferase increased 36.69 34.81 48 8531 12230 1725972
Blood creatinine increased 36.33 34.81 51 8528 13895 1724307
Neurotoxicity 36.31 34.81 22 8557 2002 1736200
Hypopnoea 36.23 34.81 12 8567 253 1737949
Speech disorder 36.02 34.81 30 8549 4518 1733684
Sudden death 35.66 34.81 25 8554 2915 1735287
Delayed graft function 35.49 34.81 10 8569 119 1738083
Large intestine perforation 35.38 34.81 18 8561 1164 1737038
Body temperature increased 35.38 34.81 24 8555 2653 1735549
Sepsis 35.08 34.81 60 8519 19378 1718824

Pharmacologic Action:

SourceCodeDescription
ATC N02AA01 NERVOUS SYSTEM
ANALGESICS
OPIOIDS
Natural opium alkaloids
ATC A07DA52 ALIMENTARY TRACT AND METABOLISM
ANTIDIARRHEALS, INTESTINAL ANTIINFLAMMATORY/ANTIINFECTIVE AGENTS
ANTIPROPULSIVES
Antipropulsives
ATC N02AA51 NERVOUS SYSTEM
ANALGESICS
OPIOIDS
Natural opium alkaloids
ATC N02AG01 NERVOUS SYSTEM
ANALGESICS
OPIOIDS
Opioids in combination with antispasmodics
ATC R05DA05 RESPIRATORY SYSTEM
COUGH AND COLD PREPARATIONS
COUGH SUPPRESSANTS, EXCL. COMBINATIONS WITH EXPECTORANTS
Opium alkaloids and derivatives
FDA MoA N0000175684 Full Opioid Agonists
FDA EPC N0000175690 Opioid Agonist
MeSH PA D000700 Analgesics
MeSH PA D000701 Analgesics, Opioid
CHEBI has role CHEBI:55322 mu-opioid receptor agonist
CHEBI has role CHEBI:35620 vasodilator agent
CHEBI has role CHEBI:38867 anaesthetic
CHEBI has role CHEBI:35482 opioid analgesic
CHEBI has role CHEBI:88188 drug allergen
MeSH PA D002491 Central Nervous System Agents
MeSH PA D002492 Central Nervous System Depressants
MeSH PA D009294 Narcotics
MeSH PA D018373 Peripheral Nervous System Agents
MeSH PA D018689 Sensory System Agents

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Pain indication 22253000
General anesthesia indication 50697003
Diarrhea indication 62315008
Severe pain indication 76948002
Chronic pain indication 82423001
Local anesthesia indication 386761002
Acute postoperative pain indication 107401000119105
Regional Anesthesia for Surgery indication
Regional Anesthesia for Labor Pain indication
Chronic Pain with Opioid Tolerance indication
Neuropathic pain off-label use 247398009
Neonatal Abstinence Syndrome off-label use 414819007 DOID:9828
Sedation in Intubated Patients off-label use
Neonatal Opioid Dependence off-label use
Brain damage contraindication 2470005
Priapism contraindication 6273006 DOID:9286
Tachyarrhythmia contraindication 6285003
Urinary tract obstruction contraindication 7163005 DOID:5200
Alcoholism contraindication 7200002
Alcohol withdrawal delirium contraindication 8635005
Dyskinesia contraindication 9748009
Chronic obstructive lung disease contraindication 13645005 DOID:3083
Severe chronic ulcerative colitis contraindication 14311001
Chronic disease of respiratory system contraindication 17097001
Acute vomiting contraindication 23971007
Alcohol intoxication contraindication 25702006
Shock contraindication 27942005
Toxic megacolon contraindication 28536002 DOID:1770
Orthostatic hypotension contraindication 28651003
Atony of colon contraindication 29479008
Hypercapnia contraindication 29596007
Torsades de pointes contraindication 31722008
Hyperthyroidism contraindication 34486009 DOID:7998
Depressive disorder contraindication 35489007
Hypertensive disorder contraindication 38341003 DOID:10763
Disorder of gallbladder contraindication 39621005 DOID:0060262
Hypothyroidism contraindication 40930008 DOID:1459
Complete trisomy 21 syndrome contraindication 41040004 DOID:14250
Hypokalemia contraindication 43339004
Low blood pressure contraindication 45007003
Achalasia of esophagus contraindication 45564002 DOID:9164
Chronic heart failure contraindication 48447003
Paralytic ileus contraindication 55525008 DOID:8442
Peptic reflux disease contraindication 57643001
Acute nephropathy contraindication 58574008
Hepatic failure contraindication 59927004
Cerebrovascular disease contraindication 62914000 DOID:6713
Ulcerative colitis contraindication 64766004 DOID:8577
Drug AND/OR toxin-induced diarrhea contraindication 65979008
Substance abuse contraindication 66214007
Benign intracranial hypertension contraindication 68267002 DOID:11459
Psychotic disorder contraindication 69322001
Sleep apnea contraindication 73430006 DOID:0050847
Pancreatitis contraindication 75694006 DOID:4989
Urethral stricture contraindication 76618002
Spastic paralysis contraindication 78403003
Disturbance of salivary secretion contraindication 78948009
Decreased respiratory function contraindication 80954004
Injury of head contraindication 82271004
Cor pulmonale contraindication 83291003 DOID:8515
Hiatal hernia contraindication 84089009 DOID:12642
Epilepsy contraindication 84757009 DOID:1826
Kidney disease contraindication 90708001 DOID:557
Myasthenia gravis contraindication 91637004 DOID:437
Disorder of biliary tract contraindication 105997008 DOID:9741
Prolonged QT interval contraindication 111975006
Gastrointestinal obstruction contraindication 126765001
Seizure disorder contraindication 128613002
Autonomic dysreflexia contraindication 129618003
Bleeding contraindication 131148009
Hypomagnesemia contraindication 190855004
Alcohol withdrawal syndrome contraindication 191480000
Drug-induced psychosis contraindication 191483003 DOID:1742
Acute pancreatitis contraindication 197456007 DOID:2913
Impaired renal function disorder contraindication 197663003
Myocardial dysfunction contraindication 233928007
Disease of liver contraindication 235856003 DOID:409
Chronic diarrhea contraindication 236071009
Bladder outflow obstruction contraindication 236645006
Pyloric obstruction contraindication 244815007
Benign prostatic hyperplasia contraindication 266569009
Retention of urine contraindication 267064002
Drowsy contraindication 271782001
Primary adrenocortical insufficiency contraindication 373662000
Angle-closure glaucoma contraindication 392291006 DOID:13550
Gastric ulcer contraindication 397825006 DOID:10808
Chronic lung disease contraindication 413839001
Disorder of coronary artery contraindication 414024009
Central nervous system depression contraindication 418072004
Congenital long QT syndrome contraindication 442917000
Acute exacerbation of asthma contraindication 708038006
Predisposition to Nausea and Vomiting contraindication
Pain in Opioid Naive Patients contraindication
Progressive Angina Pectoris contraindication
Severe Nausea contraindication

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 9.71 acidic
pKa2 8.38 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
100MG EMBEDA ALPHARMA PHARMS N022321 Aug. 13, 2009 DISCN CAPSULE, EXTENDED RELEASE ORAL 8685443 July 3, 2025 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG TERM OPIOID TREATMENT BY ORALLY ADMINISTERING A PLURALITY OF COMPOSITE SUBUNITS AS CLAIMED
20MG EMBEDA ALPHARMA PHARMS N022321 Aug. 13, 2009 DISCN CAPSULE, EXTENDED RELEASE ORAL 8685443 July 3, 2025 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG TERM OPIOID TREATMENT BY ORALLY ADMINISTERING A PLURALITY OF COMPOSITE SUBUNITS AS CLAIMED
30MG EMBEDA ALPHARMA PHARMS N022321 Aug. 13, 2009 DISCN CAPSULE, EXTENDED RELEASE ORAL 8685443 July 3, 2025 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG TERM OPIOID TREATMENT BY ORALLY ADMINISTERING A PLURALITY OF COMPOSITE SUBUNITS AS CLAIMED
50MG EMBEDA ALPHARMA PHARMS N022321 Aug. 13, 2009 DISCN CAPSULE, EXTENDED RELEASE ORAL 8685443 July 3, 2025 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG TERM OPIOID TREATMENT BY ORALLY ADMINISTERING A PLURALITY OF COMPOSITE SUBUNITS AS CLAIMED
60MG EMBEDA ALPHARMA PHARMS N022321 Aug. 13, 2009 DISCN CAPSULE, EXTENDED RELEASE ORAL 8685443 July 3, 2025 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG TERM OPIOID TREATMENT BY ORALLY ADMINISTERING A PLURALITY OF COMPOSITE SUBUNITS AS CLAIMED
80MG EMBEDA ALPHARMA PHARMS N022321 Aug. 13, 2009 DISCN CAPSULE, EXTENDED RELEASE ORAL 8685443 July 3, 2025 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG TERM OPIOID TREATMENT BY ORALLY ADMINISTERING A PLURALITY OF COMPOSITE SUBUNITS AS CLAIMED
100MG EMBEDA ALPHARMA PHARMS N022321 Aug. 13, 2009 DISCN CAPSULE, EXTENDED RELEASE ORAL 7682633 June 19, 2027 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG TERM OPIOID TREATEMENT BY ORALLY ADMINISTERING AN INTACT COMPOSITION AS CLAIMED.
100MG EMBEDA ALPHARMA PHARMS N022321 Aug. 13, 2009 DISCN CAPSULE, EXTENDED RELEASE ORAL 8158156 June 19, 2027 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG TERM OPIOID TREATEMENT BY ORALLY ADMINISTERING AN INTACT COMPOSITION AS CLAIMED.
20MG EMBEDA ALPHARMA PHARMS N022321 Aug. 13, 2009 DISCN CAPSULE, EXTENDED RELEASE ORAL 7682633 June 19, 2027 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG TERM OPIOID TREATEMENT BY ORALLY ADMINISTERING AN INTACT COMPOSITION AS CLAIMED.
20MG EMBEDA ALPHARMA PHARMS N022321 Aug. 13, 2009 DISCN CAPSULE, EXTENDED RELEASE ORAL 8158156 June 19, 2027 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG TERM OPIOID TREATEMENT BY ORALLY ADMINISTERING AN INTACT COMPOSITION AS CLAIMED.
30MG EMBEDA ALPHARMA PHARMS N022321 Aug. 13, 2009 DISCN CAPSULE, EXTENDED RELEASE ORAL 7682633 June 19, 2027 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG TERM OPIOID TREATEMENT BY ORALLY ADMINISTERING AN INTACT COMPOSITION AS CLAIMED.
30MG EMBEDA ALPHARMA PHARMS N022321 Aug. 13, 2009 DISCN CAPSULE, EXTENDED RELEASE ORAL 8158156 June 19, 2027 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG TERM OPIOID TREATEMENT BY ORALLY ADMINISTERING AN INTACT COMPOSITION AS CLAIMED.
50MG EMBEDA ALPHARMA PHARMS N022321 Aug. 13, 2009 DISCN CAPSULE, EXTENDED RELEASE ORAL 7682633 June 19, 2027 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG TERM OPIOID TREATEMENT BY ORALLY ADMINISTERING AN INTACT COMPOSITION AS CLAIMED.
50MG EMBEDA ALPHARMA PHARMS N022321 Aug. 13, 2009 DISCN CAPSULE, EXTENDED RELEASE ORAL 8158156 June 19, 2027 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG TERM OPIOID TREATEMENT BY ORALLY ADMINISTERING AN INTACT COMPOSITION AS CLAIMED.
60MG EMBEDA ALPHARMA PHARMS N022321 Aug. 13, 2009 DISCN CAPSULE, EXTENDED RELEASE ORAL 7682633 June 19, 2027 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG TERM OPIOID TREATEMENT BY ORALLY ADMINISTERING AN INTACT COMPOSITION AS CLAIMED.
60MG EMBEDA ALPHARMA PHARMS N022321 Aug. 13, 2009 DISCN CAPSULE, EXTENDED RELEASE ORAL 8158156 June 19, 2027 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG TERM OPIOID TREATEMENT BY ORALLY ADMINISTERING AN INTACT COMPOSITION AS CLAIMED.
80MG EMBEDA ALPHARMA PHARMS N022321 Aug. 13, 2009 DISCN CAPSULE, EXTENDED RELEASE ORAL 7682633 June 19, 2027 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG TERM OPIOID TREATEMENT BY ORALLY ADMINISTERING AN INTACT COMPOSITION AS CLAIMED.
80MG EMBEDA ALPHARMA PHARMS N022321 Aug. 13, 2009 DISCN CAPSULE, EXTENDED RELEASE ORAL 8158156 June 19, 2027 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG TERM OPIOID TREATEMENT BY ORALLY ADMINISTERING AN INTACT COMPOSITION AS CLAIMED.
100MG EMBEDA ALPHARMA PHARMS N022321 Aug. 13, 2009 DISCN CAPSULE, EXTENDED RELEASE ORAL 8623418 Nov. 7, 2029 TREATMENT OF MODERATE TO SEVERE CHRONIC PAIN BY ADMINISTERING AN INTACT COMPOSITION AS CLAIMED
20MG EMBEDA ALPHARMA PHARMS N022321 Aug. 13, 2009 DISCN CAPSULE, EXTENDED RELEASE ORAL 8623418 Nov. 7, 2029 TREATMENT OF MODERATE TO SEVERE CHRONIC PAIN BY ADMINISTERING AN INTACT COMPOSITION AS CLAIMED
30MG EMBEDA ALPHARMA PHARMS N022321 Aug. 13, 2009 DISCN CAPSULE, EXTENDED RELEASE ORAL 8623418 Nov. 7, 2029 TREATMENT OF MODERATE TO SEVERE CHRONIC PAIN BY ADMINISTERING AN INTACT COMPOSITION AS CLAIMED
50MG EMBEDA ALPHARMA PHARMS N022321 Aug. 13, 2009 DISCN CAPSULE, EXTENDED RELEASE ORAL 8623418 Nov. 7, 2029 TREATMENT OF MODERATE TO SEVERE CHRONIC PAIN BY ADMINISTERING AN INTACT COMPOSITION AS CLAIMED
60MG EMBEDA ALPHARMA PHARMS N022321 Aug. 13, 2009 DISCN CAPSULE, EXTENDED RELEASE ORAL 8623418 Nov. 7, 2029 TREATMENT OF MODERATE TO SEVERE CHRONIC PAIN BY ADMINISTERING AN INTACT COMPOSITION AS CLAIMED
80MG EMBEDA ALPHARMA PHARMS N022321 Aug. 13, 2009 DISCN CAPSULE, EXTENDED RELEASE ORAL 8623418 Nov. 7, 2029 TREATMENT OF MODERATE TO SEVERE CHRONIC PAIN BY ADMINISTERING AN INTACT COMPOSITION AS CLAIMED
15MG ARYMO ER ZYLA N208603 Jan. 9, 2017 DISCN TABLET, EXTENDED RELEASE ORAL 9044402 July 1, 2033 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
15MG ARYMO ER ZYLA N208603 Jan. 9, 2017 DISCN TABLET, EXTENDED RELEASE ORAL 9549899 July 1, 2033 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
30MG ARYMO ER ZYLA N208603 Jan. 9, 2017 DISCN TABLET, EXTENDED RELEASE ORAL 9044402 July 1, 2033 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
30MG ARYMO ER ZYLA N208603 Jan. 9, 2017 DISCN TABLET, EXTENDED RELEASE ORAL 9549899 July 1, 2033 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
60MG ARYMO ER ZYLA N208603 Jan. 9, 2017 DISCN TABLET, EXTENDED RELEASE ORAL 9044402 July 1, 2033 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
60MG ARYMO ER ZYLA N208603 Jan. 9, 2017 DISCN TABLET, EXTENDED RELEASE ORAL 9549899 July 1, 2033 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
10MG/ML (10MG/ML) MORPHINE SULFATE FRESENIUS KABI USA N204223 Oct. 30, 2013 RX SOLUTION INTRAMUSCULAR, INTRAVENOUS 9192608 March 12, 2034 MANAGEMENT OF CHRONIC PAIN IN PATIENTS REQUIRING OPIOID ANALGESIA
10MG/ML (10MG/ML) MORPHINE SULFATE FRESENIUS KABI USA N204223 Oct. 30, 2013 RX SOLUTION INTRAMUSCULAR, INTRAVENOUS 9192608 March 12, 2034 TREATMENT OF PAIN
2MG/ML (2MG/ML) MORPHINE SULFATE FRESENIUS KABI USA N204223 Oct. 30, 2013 RX SOLUTION INTRAMUSCULAR, INTRAVENOUS 9192608 March 12, 2034 MANAGEMENT OF CHRONIC PAIN IN PATIENTS REQUIRING OPIOID ANALGESIA
2MG/ML (2MG/ML) MORPHINE SULFATE FRESENIUS KABI USA N204223 Oct. 30, 2013 RX SOLUTION INTRAMUSCULAR, INTRAVENOUS 9192608 March 12, 2034 TREATMENT OF PAIN
4MG/ML (4MG/ML) MORPHINE SULFATE FRESENIUS KABI USA N204223 Oct. 30, 2013 RX SOLUTION INTRAMUSCULAR, INTRAVENOUS 9192608 March 12, 2034 MANAGEMENT OF CHRONIC PAIN IN PATIENTS REQUIRING OPIOID ANALGESIA
4MG/ML (4MG/ML) MORPHINE SULFATE FRESENIUS KABI USA N204223 Oct. 30, 2013 RX SOLUTION INTRAMUSCULAR, INTRAVENOUS 9192608 March 12, 2034 TREATMENT OF PAIN
5MG/ML (5MG/ML) MORPHINE SULFATE FRESENIUS KABI USA N204223 Oct. 30, 2013 RX SOLUTION INTRAMUSCULAR, INTRAVENOUS 9192608 March 12, 2034 MANAGEMENT OF CHRONIC PAIN IN PATIENTS REQUIRING OPIOID ANALGESIA
5MG/ML (5MG/ML) MORPHINE SULFATE FRESENIUS KABI USA N204223 Oct. 30, 2013 RX SOLUTION INTRAMUSCULAR, INTRAVENOUS 9192608 March 12, 2034 TREATMENT OF PAIN
8MG/ML (8MG/ML) MORPHINE SULFATE FRESENIUS KABI USA N204223 Oct. 30, 2013 RX SOLUTION INTRAMUSCULAR, INTRAVENOUS 9192608 March 12, 2034 MANAGEMENT OF CHRONIC PAIN IN PATIENTS REQUIRING OPIOID ANALGESIA
8MG/ML (8MG/ML) MORPHINE SULFATE FRESENIUS KABI USA N204223 Oct. 30, 2013 RX SOLUTION INTRAMUSCULAR, INTRAVENOUS 9192608 March 12, 2034 TREATMENT OF PAIN

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Mu-type opioid receptor GPCR AGONIST EC50 7.86 WOMBAT-PK CHEMBL
Solute carrier family 22 member 1 Transporter IC50 4.55 CHEMBL
Delta-type opioid receptor GPCR Ki 6.62 WOMBAT-PK
Kappa-type opioid receptor GPCR Ki 6.97 WOMBAT-PK
Dopamine receptor GPCR IC50 8.27 CHEMBL
Kappa-type opioid receptor GPCR Ki 7.62 CHEMBL
Delta-type opioid receptor GPCR Ki 7 CHEMBL
Mu-type opioid receptor GPCR Ki 8.92 CHEMBL
Kappa-type opioid receptor GPCR Ki 7.57 CHEMBL
Delta-type opioid receptor GPCR Ki 8.74 CHEMBL
Mu-type opioid receptor GPCR Ki 9.30 CHEMBL
Mu-type opioid receptor GPCR Ki 9.11 CHEMBL
Kappa-type opioid receptor GPCR Ki 6.52 CHEMBL
Nociceptin receptor GPCR Ki 7.86 CHEMBL
Mu-type opioid receptor GPCR Ki 9.06 CHEMBL
Opioid receptor GPCR IC50 7.57 CHEMBL
Opioid receptor GPCR Ki 8.22 CHEMBL
Mu opioid receptor-like OR2 Unclassified Ki 6.73 CHEMBL

External reference:

IDSource
C0770901 UMLSCUI
D00842 KEGG_DRUG
76I7G6D29C UNII
73572009 SNOMEDCT_US
4017530 VANDF
7052 RXNORM
373529000 SNOMEDCT_US
d00308 MMSL
001545 NDDF
CHEBI:17303 CHEBI
CHEMBL70 ChEMBL_ID
DB00295 DRUGBANK_ID
CHEMBL556578 ChEMBL_ID
52-26-6 SECONDARY_CAS_RN
MOI PDB_CHEM_ID
5288826 PUBCHEM_CID
D009020 MESH_DESCRIPTOR_UI
CHEMBL2096625 ChEMBL_ID
CHEMBL2103744 ChEMBL_ID
1627 IUPHAR_LIGAND_ID

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Kadian HUMAN PRESCRIPTION DRUG LABEL 1 0023-6011 CAPSULE, EXTENDED RELEASE 10 mg ORAL NDA 20 sections
Kadian HUMAN PRESCRIPTION DRUG LABEL 1 0023-6012 CAPSULE, EXTENDED RELEASE 20 mg ORAL NDA 20 sections
Kadian HUMAN PRESCRIPTION DRUG LABEL 1 0023-6013 CAPSULE, EXTENDED RELEASE 30 mg ORAL NDA 20 sections
Kadian HUMAN PRESCRIPTION DRUG LABEL 1 0023-6014 CAPSULE, EXTENDED RELEASE 40 mg ORAL NDA 20 sections
Kadian HUMAN PRESCRIPTION DRUG LABEL 1 0023-6015 CAPSULE, EXTENDED RELEASE 50 mg ORAL NDA 20 sections
Kadian HUMAN PRESCRIPTION DRUG LABEL 1 0023-6016 CAPSULE, EXTENDED RELEASE 60 mg ORAL NDA 20 sections
Kadian HUMAN PRESCRIPTION DRUG LABEL 1 0023-6017 CAPSULE, EXTENDED RELEASE 80 mg ORAL NDA 20 sections
Kadian HUMAN PRESCRIPTION DRUG LABEL 1 0023-6018 CAPSULE, EXTENDED RELEASE 100 mg ORAL NDA 20 sections
Kadian HUMAN PRESCRIPTION DRUG LABEL 1 0023-6019 CAPSULE, EXTENDED RELEASE 200 mg ORAL NDA 20 sections
Morphine Sulfate HUMAN PRESCRIPTION DRUG LABEL 1 0054-0235 TABLET 15 mg ORAL NDA 19 sections
Morphine Sulfate HUMAN PRESCRIPTION DRUG LABEL 1 0054-0236 TABLET 30 mg ORAL NDA 19 sections
Morphine Sulfate HUMAN PRESCRIPTION DRUG LABEL 1 0054-0237 SOLUTION 10 mg ORAL NDA 20 sections
Morphine Sulfate HUMAN PRESCRIPTION DRUG LABEL 1 0054-0238 SOLUTION 20 mg ORAL NDA 20 sections
Morphine Sulfate HUMAN PRESCRIPTION DRUG LABEL 1 0054-0404 SOLUTION 100 mg ORAL NDA 20 sections
Morphine Sulfate HUMAN PRESCRIPTION DRUG LABEL 1 0054-0517 SOLUTION 100 mg ORAL NDA 20 sections
Morphine Sulfate HUMAN PRESCRIPTION DRUG LABEL 1 0115-1277 CAPSULE, EXTENDED RELEASE 20 mg ORAL ANDA 21 sections
Morphine Sulfate HUMAN PRESCRIPTION DRUG LABEL 1 0115-1278 CAPSULE, EXTENDED RELEASE 30 mg ORAL ANDA 21 sections
Morphine Sulfate HUMAN PRESCRIPTION DRUG LABEL 1 0115-1279 CAPSULE, EXTENDED RELEASE 50 mg ORAL ANDA 21 sections
Morphine Sulfate HUMAN PRESCRIPTION DRUG LABEL 1 0115-1280 CAPSULE, EXTENDED RELEASE 60 mg ORAL ANDA 21 sections
Morphine Sulfate HUMAN PRESCRIPTION DRUG LABEL 1 0115-1281 CAPSULE, EXTENDED RELEASE 80 mg ORAL ANDA 21 sections
Morphine Sulfate HUMAN PRESCRIPTION DRUG LABEL 1 0115-1282 CAPSULE, EXTENDED RELEASE 100 mg ORAL ANDA 21 sections
Morphine Sulfate HUMAN PRESCRIPTION DRUG LABEL 1 0115-1479 CAPSULE, EXTENDED RELEASE 40 mg ORAL ANDA 21 sections
Morphine Sulfate HUMAN PRESCRIPTION DRUG LABEL 1 0121-0825 SOLUTION 100 mg ORAL ANDA 21 sections
Opium Tincture Deodorized HUMAN PRESCRIPTION DRUG LABEL 1 0187-4203 SOLUTION 10 mg ORAL Unapproved drug other 13 sections
Morphine sulfate HUMAN PRESCRIPTION DRUG LABEL 1 0228-3090 CAPSULE, EXTENDED RELEASE 30 mg ORAL ANDA 21 sections
Morphine sulfate HUMAN PRESCRIPTION DRUG LABEL 1 0228-3091 CAPSULE, EXTENDED RELEASE 60 mg ORAL ANDA 21 sections
Morphine sulfate HUMAN PRESCRIPTION DRUG LABEL 1 0228-3092 CAPSULE, EXTENDED RELEASE 90 mg ORAL ANDA 21 sections
Morphine sulfate HUMAN PRESCRIPTION DRUG LABEL 1 0228-3093 CAPSULE, EXTENDED RELEASE 120 mg ORAL ANDA 21 sections
Morphine sulfate HUMAN PRESCRIPTION DRUG LABEL 1 0228-3116 CAPSULE, EXTENDED RELEASE 45 mg ORAL ANDA 21 sections
Morphine sulfate HUMAN PRESCRIPTION DRUG LABEL 1 0228-3117 CAPSULE, EXTENDED RELEASE 75 mg ORAL ANDA 21 sections