codeine 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
725 76-57-3

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • codeine phosphate anhydrous
  • codeine anhydrous
  • codeine monohydrate
  • codeine
  • (-)-Codeine
  • morphine monomethyl ether
  • methylmorphine
  • codeine phosphate
  • codeine sulfate
  • codeine phosphate hydrate
  • codeine polistirex
  • N-Methylmorphine
An opioid analgesic related to MORPHINE but with less potent analgesic properties and mild sedative effects. It also acts centrally to suppress cough.
  • Molecular weight: 299.37
  • Formula: C18H21NO3
  • CLOGP: 0.98
  • LIPINSKI: 0
  • HAC: 4
  • HDO: 1
  • TPSA: 41.93
  • ALOGS: -2.72
  • ROTB: 1
  • Status: OFP
    • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
0.10 g O

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 1 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 435 mg/mL Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 0.10 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 20.04 µM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 50 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution) 3.50 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 15 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.70 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 4 hours Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
Jan. 21, 1952 FDA ANI PHARMS

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 5535.97 12.31 3837 71892 247173 50282222
Blood parathyroid hormone decreased 503.17 12.31 235 75494 6879 50522516
Panniculitis 463.33 12.31 235 75494 8268 50521127
Granuloma skin 457.88 12.31 207 75522 5611 50523784
Rheumatoid nodule 387.34 12.31 240 75489 12495 50516900
Skin necrosis 364.38 12.31 218 75511 10649 50518746
Rheumatoid arthritis 345.17 12.31 863 74866 201687 50327708
Toxicity to various agents 322.60 12.31 867 74862 211632 50317763
Hypercalcaemia 293.06 12.31 258 75471 23094 50506301
Contrast media allergy 270.25 12.31 105 75624 1922 50527473
Basal cell carcinoma 269.28 12.31 246 75483 23110 50506285
Ulcer 253.11 12.31 223 75506 19977 50509418
Drug eruption 251.62 12.31 238 75491 23368 50506027
Skin ulcer 228.43 12.31 273 75456 35045 50494350
Drug intolerance 211.42 12.31 764 74965 218340 50311055
Tenosynovitis 198.94 12.31 148 75581 10417 50518978
Inflammation 179.91 12.31 313 75416 56599 50472796
Drug abuse 173.59 12.31 317 75412 59529 50469866
Rash pruritic 169.64 12.31 277 75452 47569 50481826
Red blood cell sedimentation rate increased 151.49 12.31 203 75526 29213 50500182
Drug tolerance decreased 145.51 12.31 116 75613 9044 50520351
Enthesopathy 138.19 12.31 102 75627 7091 50522304
Loss of personal independence in daily activities 136.70 12.31 315 75414 69735 50459660
Peripheral swelling 135.88 12.31 639 75090 205297 50324098
White blood cell count abnormal 134.45 12.31 90 75639 5350 50524045
Soft tissue disorder 129.58 12.31 80 75649 4134 50525261
Red blood cell sedimentation rate 128.20 12.31 75 75654 3511 50525884
Substance abuse 121.03 12.31 76 75653 4048 50525347
Tongue disorder 111.95 12.31 100 75629 9116 50520279
Product dose omission issue 110.96 12.31 69 75660 183769 50345626
Herpes zoster 110.24 12.31 292 75437 70494 50458901
Contraindicated product administered 105.42 12.31 472 75257 148486 50380909
Gastric pH decreased 105.25 12.31 39 75690 623 50528772
Musculoskeletal stiffness 99.22 12.31 418 75311 128063 50401332
C-reactive protein abnormal 98.53 12.31 161 75568 27648 50501747
Derealisation 97.74 12.31 42 75687 1004 50528391
C-reactive protein increased 97.27 12.31 268 75461 66206 50463189
Infusion related reaction 87.24 12.31 491 75238 169066 50360329
Tendonitis 87.09 12.31 116 75613 16589 50512806
Obliterative bronchiolitis 83.19 12.31 45 75684 1808 50527587
Depersonalisation/derealisation disorder 82.91 12.31 39 75690 1159 50528236
H1N1 influenza 77.94 12.31 41 75688 1556 50527839
Drug dependence 74.93 12.31 118 75611 19641 50509754
Alanine aminotransferase abnormal 71.12 12.31 55 75674 4101 50525294
Alanine aminotransferase increased 69.36 12.31 289 75440 88070 50441325
Feeling of despair 68.97 12.31 41 75688 1977 50527418
Cogwheel rigidity 68.40 12.31 39 75690 1738 50527657
Asphyxia 68.13 12.31 60 75669 5367 50524028
Aspartate aminotransferase increased 67.52 12.31 263 75466 77735 50451660
Rash 67.11 12.31 971 74758 436500 50092895
Anaphylactic reaction 65.69 12.31 204 75525 53851 50475544
Dissociation 61.71 12.31 40 75689 2251 50527144
Feeling of body temperature change 60.34 12.31 51 75678 4316 50525079
Treatment failure 60.13 12.31 382 75347 137255 50392140
Pancytopenia 58.83 12.31 26 75703 84004 50445391
Psoriatic arthropathy 58.55 12.31 179 75550 46853 50482542
Fall 58.51 12.31 280 75449 334652 50194743
Joint swelling 57.40 12.31 590 75139 244696 50284699
Blood pressure systolic increased 56.96 12.31 148 75581 35301 50494094
Pneumonia viral 56.40 12.31 60 75669 6774 50522621
Schizophrenia 55.91 12.31 62 75667 7335 50522060
Platelet count decreased 55.14 12.31 42 75687 100684 50428711
Asthenia 54.97 12.31 268 75461 318774 50210621
Urinary tract infection 54.90 12.31 163 75566 223857 50305538
Serotonin syndrome 54.78 12.31 117 75612 24596 50504799
Injection site erythema 54.36 12.31 22 75707 74914 50454481
Wrist surgery 52.23 12.31 25 75704 773 50528622
Fibromyalgia 52.13 12.31 167 75562 44811 50484584
Therapeutic product effect decreased 51.84 12.31 365 75364 135685 50393710
Patient uncooperative 51.09 12.31 16 75713 148 50529247
Dehydration 50.03 12.31 95 75634 152354 50377041
Fear of injection 49.34 12.31 53 75676 6050 50523345
Hospitalisation 49.19 12.31 20 75709 67917 50461478
Overdose 48.74 12.31 285 75444 99442 50429953
Muscle disorder 48.52 12.31 45 75684 4305 50525090
Gastric disorder 48.12 12.31 124 75605 29424 50499971
Musculoskeletal disorder 47.87 12.31 90 75639 17259 50512136
Drooling 47.74 12.31 40 75689 3344 50526051
Hallucinations, mixed 46.84 12.31 43 75686 4060 50525335
White blood cell count decreased 46.50 12.31 64 75665 116658 50412737
Synovitis 45.84 12.31 330 75399 123535 50405860
Renal papillary necrosis 45.70 12.31 16 75713 215 50529180
Urticaria 45.56 12.31 341 75388 129220 50400175
Body temperature decreased 45.18 12.31 85 75644 16310 50513085
Loss of employment 43.48 12.31 28 75701 1558 50527837
Renal failure 42.94 12.31 58 75671 106575 50422820
Deformity 42.71 12.31 56 75673 7884 50521511
Wrong technique in product usage process 42.43 12.31 15 75714 55495 50473900
Drug tolerance 41.62 12.31 44 75685 4932 50524463
Pancreatic fibrosis 41.00 12.31 12 75717 86 50529309
Necrosis ischaemic 40.38 12.31 21 75708 778 50528617
Parosmia 40.30 12.31 41 75688 4395 50525000
Liver function test abnormal 39.57 12.31 151 75578 44188 50485207
Oedema peripheral 39.35 12.31 114 75615 157847 50371548
Toxicologic test abnormal 39.21 12.31 19 75710 604 50528791
Injection site pain 38.36 12.31 67 75662 110957 50418438
Fatigue 38.25 12.31 789 74940 706812 49822583
Visceral congestion 37.51 12.31 15 75714 297 50529098
Neutropenic sepsis 37.32 12.31 72 75657 14075 50515320
Menstrual disorder 37.19 12.31 39 75690 4331 50525064
Tuberculosis 36.55 12.31 59 75670 10024 50519371
Sinusitis 36.30 12.31 132 75597 170426 50358969
Miosis 36.29 12.31 46 75683 6264 50523131
Therapeutic product ineffective 36.25 12.31 23 75706 1247 50528148
Paralysis 36.02 12.31 54 75675 8610 50520785
Nightmare 35.47 12.31 76 75653 16010 50513385
Depression 35.22 12.31 128 75601 165295 50364100
Blood pressure systolic decreased 34.86 12.31 43 75686 5696 50523699
Disease progression 34.83 12.31 56 75673 95810 50433585
Hypotension 34.34 12.31 209 75520 235260 50294135
Libido increased 34.21 12.31 22 75707 1221 50528174
Needle issue 34.11 12.31 48 75681 7227 50522168
No adverse event 33.72 12.31 5 75724 33573 50495822
COVID-19 33.35 12.31 14 75715 46648 50482747
Blood cholesterol increased 31.79 12.31 165 75564 55050 50474345
Restless legs syndrome 31.54 12.31 72 75657 15825 50513570
Respiratory depression 31.53 12.31 61 75668 11949 50517446
Death 31.52 12.31 323 75406 325056 50204339
Haematocrit decreased 31.27 12.31 7 75722 34969 50494426
Haemoglobin decreased 30.81 12.31 93 75636 127123 50402272
Injection site swelling 30.72 12.31 12 75717 41761 50487634
Soft tissue injury 30.67 12.31 22 75707 1462 50527933
Atrial fibrillation 30.31 12.31 67 75662 101678 50427717
Cerebrovascular accident 30.17 12.31 60 75669 94620 50434775
Metastases to eye 29.44 12.31 10 75719 122 50529273
Bradypnoea 29.00 12.31 29 75700 3045 50526350
Finger deformity 28.91 12.31 39 75690 5643 50523752
Neutropenia 28.60 12.31 119 75610 147846 50381549
Blood potassium decreased 28.20 12.31 10 75719 36935 50492460
Unevaluable event 28.16 12.31 17 75712 46049 50483346
Post-traumatic neck syndrome 27.82 12.31 23 75706 1887 50527508
Incontinence 27.80 12.31 52 75677 9933 50519462
Nervous system disorder 27.37 12.31 69 75660 16154 50513241
Hypokalaemia 26.99 12.31 57 75672 87935 50441460
Acarodermatitis 26.97 12.31 17 75712 911 50528484
Poisoning deliberate 26.93 12.31 45 75684 7867 50521528
Pneumonia streptococcal 26.64 12.31 21 75708 1610 50527785
Respiratory failure 26.38 12.31 61 75668 91120 50438275
Hyperhidrosis 26.31 12.31 226 75503 89200 50440195
Deep vein thrombosis postoperative 26.26 12.31 21 75708 1644 50527751
Hypersensitivity 26.21 12.31 460 75269 214701 50314694
Soft tissue swelling 26.19 12.31 17 75712 959 50528436
Feeling jittery 26.08 12.31 54 75675 11106 50518289
Hypoglycaemia 26.07 12.31 25 75704 53556 50475839
Somnolence 26.05 12.31 350 75379 154635 50374760
Swollen tongue 25.95 12.31 98 75631 28532 50500863
Muscle rigidity 25.90 12.31 50 75679 9779 50519616
Sepsis 25.63 12.31 107 75622 132818 50396577
Neuropathy peripheral 25.44 12.31 68 75661 96689 50432706
Lower respiratory tract infection 25.14 12.31 235 75494 94966 50434429
Hostility 25.01 12.31 21 75708 1761 50527634
Sternal fracture 24.86 12.31 22 75707 1980 50527415
Rheumatoid lung 24.64 12.31 24 75705 2441 50526954
Beta haemolytic streptococcal infection 24.52 12.31 21 75708 1809 50527586
Accidental exposure to product 24.18 12.31 3 75726 23054 50506341
Pulmonary function test abnormal 23.86 12.31 18 75711 1293 50528102
Bone marrow failure 23.77 12.31 6 75723 27618 50501777
Emphysema 23.64 12.31 46 75683 9047 50520348
Duodenal ulcer repair 23.47 12.31 7 75722 54 50529341
Distributive shock 23.45 12.31 15 75714 825 50528570
Mydriasis 23.19 12.31 50 75679 10577 50518818
Cardiac failure congestive 23.18 12.31 58 75671 84324 50445071
Diaphragmatic rupture 22.89 12.31 10 75719 249 50529146
Mental status changes 22.71 12.31 13 75716 36259 50493136
Anaemia 22.66 12.31 255 75474 252201 50277194
Agitation 22.56 12.31 147 75582 53237 50476158
Sensory loss 22.42 12.31 41 75688 7697 50521698
Pulmonary hypertension 22.36 12.31 11 75718 33406 50495989
Accidental overdose 22.15 12.31 72 75657 19461 50509934
Laboratory test abnormal 22.09 12.31 4 75725 23204 50506191
Product use issue 22.08 12.31 330 75399 149145 50380250
Fluid retention 21.99 12.31 26 75703 50623 50478772
Injection site pruritus 21.91 12.31 17 75712 40394 50489001
Neuroleptic malignant syndrome 21.63 12.31 50 75679 11080 50518315
Acute respiratory failure 21.61 12.31 8 75721 28774 50500621
Pallor 21.52 12.31 80 75649 23119 50506276
Weight increased 21.39 12.31 196 75533 201695 50327700
Priapism 21.26 12.31 7 75722 77 50529318
Deep vein thrombosis 21.23 12.31 49 75680 73255 50456140
Granuloma 21.23 12.31 31 75698 4827 50524568
Mania 21.17 12.31 49 75680 10867 50518528
Transient ischaemic attack 20.96 12.31 11 75718 32199 50497196
Pneumonia 20.91 12.31 420 75309 377981 50151414
Emotional disorder 20.66 12.31 51 75678 11785 50517610
Chronic obstructive pulmonary disease 20.57 12.31 30 75699 53405 50475990
Transaminases increased 20.45 12.31 8 75721 27816 50501579
Alveolar rhabdomyosarcoma 20.38 12.31 5 75724 16 50529379
Pleural effusion 20.11 12.31 59 75670 81395 50448000
Mood swings 20.11 12.31 61 75668 15893 50513502
Limb operation 20.10 12.31 25 75704 3339 50526056
Treatment noncompliance 20.06 12.31 10 75719 30140 50499255
Sopor 19.87 12.31 3 75726 19876 50509519
Fungal infection 19.84 12.31 10 75719 29955 50499440
Multiple sclerosis relapse 19.81 12.31 21 75708 42943 50486452
Postmortem blood drug level abnormal 19.80 12.31 10 75719 348 50529047
Hypoaesthesia oral 19.55 12.31 47 75682 10681 50518714
Derailment 19.50 12.31 6 75723 52 50529343
Weight decreased 19.25 12.31 225 75504 221020 50308375
Mite allergy 19.05 12.31 11 75718 502 50528893
Acute kidney injury 19.05 12.31 234 75495 227824 50301571
Mobility decreased 18.97 12.31 193 75536 79755 50449640
Mycotic allergy 18.93 12.31 13 75716 806 50528589
Abdominal pain 18.93 12.31 475 75254 235753 50293642
Premature delivery 18.77 12.31 6 75723 23657 50505738
Haemorrhage 18.68 12.31 32 75697 53409 50475986
Diabetes mellitus 18.42 12.31 28 75701 49005 50480390
Foetal exposure during pregnancy 18.31 12.31 9 75720 27350 50502045
Tendon operation 18.26 12.31 9 75720 297 50529098
Myocardial fibrosis 18.25 12.31 12 75717 692 50528703
Precancerous cells present 18.24 12.31 15 75714 1222 50528173
Erythema 18.16 12.31 314 75415 146100 50383295
Thrombosis 18.11 12.31 35 75694 55798 50473597
Blood glucose increased 18.09 12.31 51 75678 71273 50458122
Disease recurrence 17.99 12.31 4 75725 20077 50509318
Lip swelling 17.92 12.31 79 75650 24657 50504738
Ear pain 17.90 12.31 10 75719 28273 50501122
Device issue 17.85 12.31 4 75725 19968 50509427
Gallbladder cholesterolosis 17.82 12.31 12 75717 720 50528675
Pulmonary embolism 17.71 12.31 85 75644 101619 50427776
Gastrooesophageal reflux disease 17.70 12.31 57 75672 76371 50453024
Intestinal fibrosis 17.63 12.31 7 75722 136 50529259
Cold urticaria 17.57 12.31 5 75724 32 50529363
Skin discolouration 17.56 12.31 96 75633 32661 50496734
Paradoxical psoriasis 17.53 12.31 7 75722 138 50529257
Dysmetropsia 17.53 12.31 6 75723 75 50529320
Head injury 17.50 12.31 7 75722 24013 50505382
Exposure during pregnancy 17.31 12.31 108 75621 120907 50408488
Full blood count decreased 17.14 12.31 6 75723 22340 50507055
Laryngeal dyspnoea 17.13 12.31 7 75722 147 50529248
Bronchitis 17.03 12.31 89 75640 104070 50425325
Pharyngeal swelling 16.94 12.31 27 75702 4539 50524856
Febrile neutropenia 16.79 12.31 82 75647 97585 50431810
Arthralgia 16.64 12.31 809 74920 437893 50091502
Hypoxia 16.63 12.31 32 75697 51091 50478304
Thirst 16.63 12.31 44 75685 10606 50518789
Intestinal strangulation 16.60 12.31 6 75723 89 50529306
Arthropathy 16.57 12.31 330 75399 157576 50371819
Hernia 16.53 12.31 41 75688 9502 50519893
Arthritis 16.31 12.31 200 75529 86521 50442874
Toxic shock syndrome streptococcal 16.24 12.31 6 75723 95 50529300
Thrombocytopenia 16.23 12.31 118 75611 127555 50401840
Hypervolaemia 16.16 12.31 9 75720 25490 50503905
Visual acuity reduced 16.16 12.31 5 75724 20134 50509261
Skin lesion 16.14 12.31 10 75719 26717 50502678
Gastritis fungal 16.07 12.31 6 75723 98 50529297
Delirium 16.03 12.31 105 75624 38087 50491308
Joint range of motion decreased 15.66 12.31 62 75667 18450 50510945
Upper respiratory tract infection 15.59 12.31 159 75570 65739 50463656
Gait disturbance 15.58 12.31 313 75416 149692 50379703
Coronary artery disease 15.50 12.31 13 75716 29713 50499682
Hyperglycaemia 15.47 12.31 19 75710 36386 50493009
Dystonia 15.41 12.31 46 75683 11880 50517515
Antisocial behaviour 15.29 12.31 8 75721 300 50529095
Infrequent bowel movements 15.13 12.31 13 75716 1125 50528270
Red blood cell count decreased 15.09 12.31 17 75712 33818 50495577
Therapeutic product effect incomplete 15.08 12.31 206 75523 91309 50438086
Therapy non-responder 15.03 12.31 129 75600 50893 50478502
Joint stiffness 14.91 12.31 14 75715 30294 50499101
Fear-related avoidance of activities 14.90 12.31 6 75723 121 50529274
Dyspnoea 14.90 12.31 669 75060 546939 49982456
Haematuria 14.90 12.31 10 75719 25603 50503792
Pericardial effusion 14.87 12.31 10 75719 25579 50503816
Hepatic steatosis 14.82 12.31 74 75655 24310 50505085
Drug resistance 14.73 12.31 5 75724 18984 50510411
Lip dry 14.68 12.31 26 75703 4761 50524634
Respiratory disorder 14.65 12.31 15 75714 31172 50498223
Premature labour 14.57 12.31 44 75685 11432 50517963
Red blood cell nucleated morphology present 14.57 12.31 4 75725 22 50529373
Muscular weakness 14.53 12.31 83 75646 94930 50434465
Arteriosclerosis coronary artery 14.50 12.31 34 75695 7602 50521793
Bronchitis chronic 14.48 12.31 23 75706 3854 50525541
Speech disorder 14.48 12.31 97 75632 35451 50493944
Agranulocytosis 14.41 12.31 7 75722 21414 50507981
Product quality issue 14.32 12.31 15 75714 30843 50498552
Eosinophilia 14.32 12.31 5 75724 18647 50510748
Electrolyte imbalance 14.26 12.31 4 75725 17165 50512230
Abnormal weight gain 14.26 12.31 14 75715 1438 50527957
Systemic lupus erythematosus 14.25 12.31 138 75591 140484 50388911
Lymphopenia 14.22 12.31 3 75726 15618 50513777
Pyrexia 14.22 12.31 447 75282 379756 50149639
Acute chest syndrome 14.18 12.31 10 75719 647 50528748
Cardiomyopathy 14.17 12.31 3 75726 15583 50513812
Procedural anxiety 14.14 12.31 10 75719 650 50528745
Sinus disorder 14.08 12.31 5 75724 18453 50510942
Cholesteatoma 13.90 12.31 6 75723 145 50529250
Musculoskeletal pain 13.81 12.31 167 75562 72010 50457385
Cyanosis 13.78 12.31 52 75677 15132 50514263
Chronic kidney disease 13.73 12.31 24 75705 39747 50489648
Staphylococcal infection 13.70 12.31 20 75709 35596 50493799
Surgery 13.66 12.31 15 75714 30190 50499205
Glaucoma 13.64 12.31 53 75676 15633 50513762
Device related infection 13.61 12.31 7 75722 20728 50508667
Post procedural complication 13.55 12.31 3 75726 15101 50514294
Proteinuria 13.54 12.31 4 75725 16593 50512802
Shock 13.51 12.31 7 75722 20643 50508752
Flushing 13.50 12.31 53 75676 66962 50462433
Anxiety 13.44 12.31 186 75543 177420 50351975
Palmar erythema 13.39 12.31 14 75715 1549 50527846
Malaise 13.39 12.31 622 75107 334910 50194485
Bone pain 13.33 12.31 32 75697 47197 50482198
Emotional distress 13.22 12.31 14 75715 28649 50500746
Influenza like illness 13.20 12.31 43 75686 57416 50471979
Anti-cyclic citrullinated peptide antibody 13.18 12.31 14 75715 1578 50527817
Chest discomfort 13.13 12.31 83 75646 92639 50436756
Lymphocyte count decreased 13.12 12.31 12 75717 26295 50503100
Drug withdrawal syndrome 13.10 12.31 73 75656 25008 50504387
Underdose 13.08 12.31 7 75722 20271 50509124
Cholelithiasis 13.03 12.31 23 75706 37950 50491445
Salt craving 12.94 12.31 5 75724 90 50529305
Haemophilus test positive 12.92 12.31 3 75726 7 50529388
Skin laceration 12.92 12.31 6 75723 18836 50510559
Respiratory distress 12.87 12.31 16 75713 30473 50498922
Tachypnoea 12.87 12.31 3 75726 14574 50514821
Hip fracture 12.73 12.31 12 75717 25919 50503476
Monoclonal gammopathy 12.47 12.31 9 75720 604 50528791
Bradycardia 12.32 12.31 52 75677 64374 50465021

FDA Adverse Event Reporting System (Male)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Drug abuse 1666.87 12.82 939 22666 78944 29471978
Toxicity to various agents 1595.14 12.82 1219 22386 172442 29378480
Drug hypersensitivity 512.95 12.82 429 23176 67977 29482945
Substance abuse 370.74 12.82 155 23450 6632 29544290
Overdose 184.53 12.82 270 23335 79549 29471373
Drug dependence 172.23 12.82 139 23466 20842 29530080
Intentional product misuse 163.12 12.82 168 23437 34493 29516429
Asphyxia 105.92 12.82 61 23544 5254 29545668
Depressed level of consciousness 97.07 12.82 133 23472 36809 29514113
Poisoning 96.69 12.82 73 23532 9920 29541002
Dysarthria 93.10 12.82 119 23486 30792 29520130
Respiratory depression 83.22 12.82 76 23529 13447 29537475
Drug interaction 67.75 12.82 324 23281 197061 29353861
Pulmonary oedema 65.22 12.82 120 23485 42615 29508307
Miosis 59.28 12.82 50 23555 7959 29542963
Nightmare 58.51 12.82 58 23547 11359 29539563
Completed suicide 58.06 12.82 181 23424 90065 29460857
Intentional overdose 48.78 12.82 100 23505 38428 29512494
Lower respiratory tract infection 46.32 12.82 79 23526 26423 29524499
Drug use disorder 42.26 12.82 29 23576 3393 29547529
Pulmonary congestion 40.80 12.82 50 23555 12386 29538536
Psychotic behaviour 39.77 12.82 16 23589 618 29550304
Vestibular disorder 37.99 12.82 18 23587 1036 29549886
Patient uncooperative 36.30 12.82 13 23592 363 29550559
Sedation 36.00 12.82 56 23549 17349 29533573
Chronic gastrointestinal bleeding 35.82 12.82 12 23593 273 29550649
Bradykinesia 35.16 12.82 26 23579 3421 29547501
Poor feeding infant 33.91 12.82 13 23592 441 29550481
Product dose omission issue 32.86 12.82 18 23587 96365 29454557
Fatigue 32.81 12.82 136 23469 316685 29234237
Accidental overdose 32.81 12.82 54 23551 17539 29533383
Poisoning deliberate 31.01 12.82 30 23575 5701 29545221
Bradyphrenia 30.55 12.82 26 23579 4188 29546734
Spinal cord infection 29.82 12.82 9 23596 144 29550778
Drug ineffective 29.46 12.82 170 23435 363000 29187922
Alcohol interaction 28.95 12.82 21 23584 2682 29548240
Chemical poisoning 28.94 12.82 8 23597 92 29550830
Prescription drug used without a prescription 28.77 12.82 16 23589 1288 29549634
Respiratory arrest 28.02 12.82 63 23542 25770 29525152
Perineal pain 27.10 12.82 13 23592 769 29550153
Prescription form tampering 26.96 12.82 11 23594 441 29550481
Alice in wonderland syndrome 25.53 12.82 5 23600 9 29550913
Nervous system neoplasm 25.38 12.82 8 23597 149 29550773
Analgesic drug level above therapeutic 25.21 12.82 9 23596 249 29550673
Red blood cell sedimentation rate 24.80 12.82 11 23594 543 29550379
Bradypnoea 24.44 12.82 18 23587 2353 29548569
Leukopenia 24.21 12.82 7 23598 55196 29495726
Cardio-respiratory arrest 24.19 12.82 92 23513 50509 29500413
Thrombocytopenia 23.46 12.82 45 23560 134778 29416144
Overgrowth bacterial 23.31 12.82 7 23598 110 29550812
Granuloma skin 23.15 12.82 11 23594 637 29550285
Sepsis 22.81 12.82 50 23555 142632 29408290
Logorrhoea 22.76 12.82 17 23588 2271 29548651
Aggression 22.55 12.82 71 23534 35470 29515452
Agitated depression 22.25 12.82 8 23597 226 29550696
Anal fissure 21.75 12.82 18 23587 2790 29548132
Calcium deficiency 21.33 12.82 7 23598 149 29550773
Drug diversion 20.76 12.82 11 23594 804 29550118
Blood parathyroid hormone decreased 20.65 12.82 11 23594 813 29550109
Tooth injury 20.57 12.82 11 23594 819 29550103
Asthenia 20.05 12.82 96 23509 215154 29335768
Morganella infection 19.96 12.82 9 23596 462 29550460
Idiopathic pulmonary fibrosis 19.86 12.82 18 23587 3150 29547772
Hospitalisation 19.86 12.82 6 23599 45982 29504940
Anaemia 19.68 12.82 88 23517 200863 29350059
Bronchial haemorrhage 19.64 12.82 10 23595 673 29550249
Hypertonic bladder 19.56 12.82 13 23592 1443 29549479
Pneumonia aspiration 19.40 12.82 69 23536 36668 29514254
Duodenal ulcer perforation 19.16 12.82 13 23592 1493 29549429
Clumsiness 19.16 12.82 13 23592 1493 29549429
Relapsing-remitting multiple sclerosis 18.99 12.82 10 23595 722 29550200
Accidental poisoning 18.50 12.82 9 23596 549 29550373
Rhinalgia 18.48 12.82 8 23597 372 29550550
Off label use 18.31 12.82 153 23452 300647 29250275
Needle fatigue 17.88 12.82 9 23596 591 29550331
Gastrointestinal mucosa hyperaemia 17.71 12.82 7 23598 258 29550664
Dehydration 17.69 12.82 41 23564 114707 29436215
Rheumatoid arthritis 17.51 12.82 61 23544 32091 29518831
Defaecation urgency 17.41 12.82 13 23592 1736 29549186
Mood swings 17.38 12.82 25 23580 7226 29543696
Nephrolithiasis 17.36 12.82 52 23553 25282 29525640
Self-medication 17.08 12.82 14 23591 2140 29548782
Drug withdrawal syndrome neonatal 16.93 12.82 17 23588 3378 29547544
Blood ethanol 16.93 12.82 5 23600 74 29550848
Patient dissatisfaction with treatment 16.81 12.82 5 23600 76 29550846
Gait spastic 16.70 12.82 9 23596 681 29550241
Panniculitis 16.64 12.82 11 23594 1210 29549712
Paratracheal lymphadenopathy 16.45 12.82 5 23600 82 29550840
Coordination abnormal 16.28 12.82 24 23581 7090 29543832
Blood alcohol increased 16.22 12.82 9 23596 721 29550201
Unresponsive to stimuli 15.75 12.82 50 23555 25076 29525846
Compartment syndrome 15.51 12.82 14 23591 2438 29548484
Analgesic drug level increased 15.11 12.82 8 23597 584 29550338
COVID-19 15.01 12.82 5 23600 36009 29514913
Pouchitis 14.85 12.82 8 23597 605 29550317
Tendon discomfort 14.69 12.82 6 23599 241 29550681
Disease progression 14.53 12.82 27 23578 81889 29469033
Abnormal weight gain 14.41 12.82 9 23596 898 29550024
Neovascular age-related macular degeneration 14.30 12.82 5 23600 130 29550792
Death 14.18 12.82 365 23240 341719 29209203
Liver function test abnormal 14.16 12.82 53 23552 28865 29522057
Increased bronchial secretion 14.08 12.82 11 23594 1570 29549352
Diabetic eye disease 14.02 12.82 4 23601 52 29550870
Phlebosclerosis 13.75 12.82 5 23600 146 29550776
Lip ulceration 13.64 12.82 8 23597 712 29550210
Chronic kidney disease 13.61 12.82 6 23599 36410 29514512
Myocardial infarction 13.56 12.82 44 23561 110252 29440670
Hyponatraemic seizure 13.56 12.82 4 23601 59 29550863
Anion gap 13.48 12.82 8 23597 728 29550194
Cystitis interstitial 13.47 12.82 5 23600 155 29550767
Pancytopenia 13.40 12.82 29 23576 83139 29467783
Hereditary angioedema 13.23 12.82 8 23597 753 29550169
Rheumatoid nodule 13.19 12.82 12 23593 2110 29548812
Coma scale abnormal 13.12 12.82 15 23590 3454 29547468

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Drug hypersensitivity 4044.05 11.73 2996 84527 234819 64176390
Toxicity to various agents 1357.41 11.73 2036 85487 361477 64049732
Drug abuse 1337.86 11.73 1238 86285 131136 64280073
Blood parathyroid hormone decreased 485.90 11.73 225 87298 7141 64404068
Panniculitis 445.92 11.73 225 87298 8654 64402555
Granuloma skin 439.89 11.73 198 87325 5876 64405333
Substance abuse 393.50 11.73 210 87313 9082 64402127
Rheumatoid nodule 381.70 11.73 229 87294 12422 64398787
Skin necrosis 306.98 11.73 209 87314 14120 64397089
Rheumatoid arthritis 272.76 11.73 653 86870 163641 64247568
Ulcer 252.94 11.73 226 87297 22764 64388445
Hypercalcaemia 231.56 11.73 248 87275 31168 64380041
Contrast media allergy 218.52 11.73 89 87434 2052 64409157
Basal cell carcinoma 216.04 11.73 237 87286 30601 64380608
Drug intolerance 205.56 11.73 641 86882 187351 64223858
Drug dependence 197.79 11.73 235 87288 33077 64378132
Skin ulcer 196.00 11.73 269 87254 43705 64367504
Drug eruption 185.64 11.73 237 87286 35899 64375310
Tenosynovitis 175.00 11.73 138 87385 11695 64399514
Inflammation 155.95 11.73 301 87222 64999 64346210
Rash pruritic 155.09 11.73 279 87244 57125 64354084
Overdose 154.40 11.73 522 87001 159044 64252165
Drug tolerance decreased 149.70 11.73 102 87421 6896 64404313
Contraindicated product administered 146.94 11.73 398 87125 107431 64303778
Red blood cell sedimentation rate increased 145.13 11.73 195 87328 31040 64380169
Asphyxia 142.40 11.73 112 87411 9454 64401755
Red blood cell sedimentation rate 135.29 11.73 76 87447 3638 64407571
Enthesopathy 122.69 11.73 103 87420 9535 64401674
Loss of personal independence in daily activities 122.21 11.73 290 87233 72164 64339045
Peripheral swelling 118.85 11.73 580 86943 208573 64202636
Respiratory depression 116.07 11.73 151 87372 23292 64387917
Infusion related reaction 112.69 11.73 482 87041 163985 64247224
Product dose omission issue 108.33 11.73 65 87458 194682 64216527
Gastric pH decreased 104.99 11.73 39 87484 696 64410513
Tongue disorder 100.91 11.73 102 87421 11978 64399231
C-reactive protein abnormal 94.00 11.73 153 87370 28894 64382315
Nightmare 88.40 11.73 125 87398 20868 64390341
Derealisation 87.31 11.73 42 87481 1453 64409756
Tendonitis 84.27 11.73 120 87403 20162 64391047
Therapeutic product effect decreased 78.91 11.73 338 87185 115013 64296196
Pancytopenia 78.04 11.73 49 87474 143260 64267949
C-reactive protein increased 77.61 11.73 294 87229 94615 64316594
Patient uncooperative 77.03 11.73 29 87494 538 64410671
Intentional product misuse 75.64 11.73 243 87280 72052 64339157
Depersonalisation/derealisation disorder 74.91 11.73 39 87484 1601 64409608
Miosis 72.87 11.73 90 87433 13176 64398033
Psoriatic arthropathy 72.70 11.73 173 87350 43108 64368101
Alanine aminotransferase abnormal 72.37 11.73 66 87457 6822 64404387
Dehydration 71.33 11.73 115 87408 216648 64194561
H1N1 influenza 70.89 11.73 42 87481 2224 64408985
Soft tissue disorder 68.29 11.73 47 87476 3229 64407980
Obliterative bronchiolitis 67.08 11.73 43 87480 2622 64408587
Anaemia 66.01 11.73 277 87246 378403 64032806
Treatment failure 65.58 11.73 323 87200 116493 64294716
Poisoning 65.11 11.73 111 87412 21768 64389441
Herpes zoster 63.67 11.73 244 87279 78943 64332266
Feeling of despair 63.57 11.73 41 87482 2527 64408682
Rash 62.52 11.73 920 86603 457629 63953580
Accidental overdose 61.71 11.73 139 87384 33418 64377791
Musculoskeletal stiffness 61.05 11.73 329 87194 122877 64288332
Feeling of body temperature change 60.35 11.73 51 87472 4763 64406446
Asthenia 60.18 11.73 338 87185 427706 63983503
Cogwheel rigidity 57.29 11.73 40 87483 2813 64408396
Fear of injection 57.00 11.73 54 87469 5858 64405351
Lower respiratory tract infection 56.26 11.73 266 87257 94348 64316861
Joint swelling 55.69 11.73 490 87033 214892 64196317
Dissociation 55.35 11.73 40 87483 2971 64408238
Sepsis 54.08 11.73 148 87375 230193 64181016
Accidental poisoning 53.65 11.73 30 87493 1423 64409786
Renal failure 52.89 11.73 104 87419 181584 64229625
White blood cell count decreased 52.60 11.73 83 87440 157754 64253455
Platelet count decreased 51.46 11.73 93 87430 167618 64243591
Muscle disorder 51.16 11.73 47 87476 4904 64406305
Disease progression 50.61 11.73 71 87452 141609 64269600
Acute kidney injury 49.83 11.73 381 87142 448859 63962350
Neutropenia 49.75 11.73 163 87360 239461 64171748
Bradypnoea 49.51 11.73 47 87476 5112 64406097
Hospitalisation 49.50 11.73 20 87503 75187 64336022
Menstrual disorder 49.22 11.73 39 87484 3326 64407883
Thrombocytopenia 48.73 11.73 149 87374 223652 64187557
Depressed level of consciousness 48.45 11.73 229 87294 81207 64330002
Synovitis 47.33 11.73 262 87261 98828 64312381
Urinary tract infection 47.07 11.73 159 87364 231437 64179772
Blood pressure systolic increased 47.05 11.73 161 87362 49292 64361917
COVID-19 46.82 11.73 15 87508 65125 64346084
Wrong technique in product usage process 46.63 11.73 15 87508 64959 64346250
Mood swings 46 11.73 84 87439 17384 64393825
Fibromyalgia 45.75 11.73 129 87394 35602 64375607
Serotonin syndrome 45.67 11.73 137 87386 39145 64372064
Injection site erythema 44.72 11.73 20 87503 70780 64340429
Febrile neutropenia 44.46 11.73 120 87403 187537 64223672
Parosmia 44.01 11.73 42 87481 4598 64406611
Poisoning deliberate 43.69 11.73 71 87452 13387 64397822
Fall 43.21 11.73 360 87163 416466 63994743
Cardiac failure congestive 43.18 11.73 69 87454 130511 64280698
Drug tolerance 43.00 11.73 47 87476 6038 64405171
Cerebrovascular accident 42.46 11.73 76 87447 137507 64273702
Visceral congestion 41.76 11.73 21 87502 801 64410408
Hallucinations, mixed 41.48 11.73 46 87477 6006 64405203
Pancreatic fibrosis 40.90 11.73 12 87511 97 64411112
Somnolence 39.77 11.73 437 87086 203208 64208001
Schizophrenia 39.11 11.73 61 87462 11107 64400102
Loss of employment 38.91 11.73 27 87496 1880 64409329
Necrosis ischaemic 38.22 11.73 21 87502 962 64410247
Wrist surgery 38.04 11.73 19 87504 714 64410495
Gastric disorder 37.96 11.73 106 87417 29091 64382118
Body temperature decreased 37.60 11.73 98 87425 25830 64385379
Mental status changes 37.51 11.73 18 87505 61144 64350065
Drooling 37.44 11.73 41 87482 5278 64405931
Neutropenic sepsis 36.91 11.73 91 87432 23181 64388028
Drug resistance 36.35 11.73 3 87520 35099 64376110
Haemoglobin decreased 36.26 11.73 139 87384 194924 64216285
Hyperhidrosis 35.85 11.73 291 87232 124629 64286580
Pneumonia viral 35.05 11.73 48 87475 7774 64403435
Therapeutic product ineffective 34.63 11.73 23 87500 1490 64409719
Atrial fibrillation 33.71 11.73 119 87404 170970 64240239
Emotional disorder 33.67 11.73 61 87462 12546 64398663
Renal papillary necrosis 33.32 11.73 14 87509 350 64410859
Therapy cessation 33.03 11.73 3 87520 32486 64378723
Chronic kidney disease 32.64 11.73 19 87504 57900 64353309
Liver function test abnormal 32.43 11.73 163 87360 59238 64351971
Aspartate aminotransferase increased 32.21 11.73 275 87248 119513 64291696
Injection site pain 32.21 11.73 64 87459 111344 64299865
Alanine aminotransferase increased 31.71 11.73 308 87215 138723 64272486
Toxicologic test abnormal 31.42 11.73 20 87503 1205 64410004
Soft tissue injury 31.38 11.73 22 87501 1557 64409652
Bone marrow failure 31.15 11.73 13 87510 47939 64363270
Haematocrit decreased 30.70 11.73 18 87505 54637 64356572
Pyrexia 30.57 11.73 554 86969 558090 63853119
Restless legs syndrome 30.46 11.73 70 87453 17046 64394163
Hypersensitivity 30.23 11.73 403 87120 196049 64215160
Premature labour 30.07 11.73 44 87479 7576 64403633
Renal impairment 30.01 11.73 89 87434 134928 64276281
Post-traumatic neck syndrome 29.89 11.73 23 87500 1879 64409330
Treatment noncompliance 29.54 11.73 11 87512 43471 64367738
Sopor 29.47 11.73 3 87520 29658 64381551
Feeling jittery 29.10 11.73 52 87471 10583 64400626
Arthralgia 28.90 11.73 795 86728 441465 63969744
Needle issue 28.86 11.73 48 87475 9224 64401985
Haematuria 28.57 11.73 24 87499 60447 64350762
Rheumatoid lung 28.51 11.73 25 87498 2454 64408755
Drug use disorder 28.42 11.73 38 87485 6016 64405193
Musculoskeletal disorder 28.38 11.73 70 87453 17836 64393373
Arthropathy 28.08 11.73 269 87254 120698 64290511
Chemical poisoning 27.98 11.73 10 87513 159 64411050
Anaphylactic reaction 27.89 11.73 174 87349 68490 64342719
Unevaluable event 27.83 11.73 17 87506 50472 64360737
Myocardial infarction 27.78 11.73 123 87400 165698 64245511
Dysarthria 27.64 11.73 156 87367 59250 64351959
Pulmonary hypertension 27.53 11.73 12 87511 43127 64368082
Acute respiratory failure 27.27 11.73 17 87506 49917 64361292
Injection site swelling 27.20 11.73 11 87512 41342 64369867
Paralysis 27.11 11.73 53 87470 11542 64399667
Lactic acidosis 27.07 11.73 26 87497 61384 64349825
Oedema peripheral 26.88 11.73 171 87352 210146 64201063
Abnormal weight gain 26.83 11.73 23 87500 2190 64409019
Septic shock 26.83 11.73 65 87458 105372 64305837
Fatigue 26.78 11.73 793 86730 747937 63663272
Dyspnoea 26.75 11.73 757 86766 717917 63693292
Libido increased 26.73 11.73 21 87502 1769 64409440
Sternal fracture 26.53 11.73 23 87500 2224 64408985
Drug withdrawal syndrome 26.44 11.73 98 87425 31193 64380016
Multiple organ dysfunction syndrome 26.21 11.73 62 87461 101351 64309858
Cardiogenic shock 26.06 11.73 6 87517 32421 64378788
Beta haemolytic streptococcal infection 25.68 11.73 21 87502 1873 64409336
Mydriasis 25.48 11.73 61 87462 15251 64395958
Agranulocytosis 25.42 11.73 10 87513 38219 64372990
Hypokalaemia 25.22 11.73 83 87440 121820 64289389
Metastases to eye 25.15 11.73 10 87513 216 64410993
Swollen tongue 25.10 11.73 104 87419 34850 64376359
Hypotension 25.05 11.73 365 87158 380609 64030600
Diaphragmatic rupture 24.94 11.73 10 87513 221 64410988
Precancerous cells present 24.82 11.73 16 87507 985 64410224
Mobility decreased 24.64 11.73 200 87323 85640 64325569
Thrombosis 24.62 11.73 36 87487 70606 64340603
Blood glucose increased 24.53 11.73 61 87462 98012 64313197
Psychotic behaviour 24.42 11.73 16 87507 1013 64410196
Deformity 24.32 11.73 36 87487 6261 64404948
Transient ischaemic attack 24.18 11.73 15 87508 44167 64367042
Acute myocardial infarction 23.84 11.73 36 87487 69682 64341527
Urticaria 23.40 11.73 304 87219 147013 64264196
Pulmonary embolism 23.07 11.73 111 87412 146245 64264964
Hostility 22.90 11.73 21 87502 2186 64409023
Product use issue 22.82 11.73 310 87213 151405 64259804
Fungal infection 22.71 11.73 9 87514 34242 64376967
Off label use 22.65 11.73 670 86853 632136 63779073
Hypervolaemia 22.38 11.73 12 87511 38273 64372936
Chronic gastrointestinal bleeding 22.31 11.73 11 87512 402 64410807
Leukopenia 22.30 11.73 67 87456 101175 64310034
Duodenal ulcer repair 22.27 11.73 7 87516 73 64411136
Neurotoxicity 22.16 11.73 5 87518 27399 64383810
Incontinence 22.16 11.73 50 87473 12031 64399178
Aggression 21.90 11.73 122 87401 46110 64365099
Gallbladder cholesterolosis 21.81 11.73 12 87511 551 64410658
Acarodermatitis 21.81 11.73 16 87507 1216 64409993
Blood cholesterol increased 21.68 11.73 129 87394 49937 64361272
Pallor 21.57 11.73 107 87416 38674 64372535
Pneumonia streptococcal 21.56 11.73 21 87502 2357 64408852
Deep vein thrombosis 21.49 11.73 72 87451 105110 64306099
Liver injury 21.45 11.73 89 87434 29843 64381366
Neuropathy peripheral 21.02 11.73 85 87438 117440 64293769
Accidental exposure to product 20.94 11.73 5 87518 26359 64384850
Haemorrhage 20.92 11.73 48 87475 79303 64331906
Alveolar rhabdomyosarcoma 20.87 11.73 5 87518 16 64411193
Device issue 20.76 11.73 3 87520 22645 64388564
Lymphocyte count decreased 20.69 11.73 15 87508 40684 64370525
Lip swelling 20.65 11.73 92 87431 31815 64379394
Proteinuria 20.61 11.73 6 87517 27717 64383492
Finger deformity 20.54 11.73 30 87493 5156 64406053
Pleural effusion 20.52 11.73 95 87428 126464 64284745
Tooth injury 20.37 11.73 16 87507 1347 64409862
Acute myeloid leukaemia 20.31 11.73 6 87517 27457 64383752
Deep vein thrombosis postoperative 20.29 11.73 16 87507 1355 64409854
Hypoaesthesia oral 20.21 11.73 47 87476 11533 64399676
Lymphopenia 20.12 11.73 5 87518 25652 64385557
Coronary artery disease 19.91 11.73 32 87491 60401 64350808
Cardiomyopathy 19.77 11.73 5 87518 25351 64385858
Disease recurrence 19.74 11.73 9 87514 31501 64379708
Abdominal pain 19.66 11.73 559 86964 311816 64099393
Illness 19.63 11.73 70 87453 21868 64389341
Respiratory failure 19.60 11.73 133 87390 161050 64250159
Transaminases increased 19.51 11.73 19 87504 44575 64366634
Full blood count abnormal 19.43 11.73 8 87515 29749 64381460
Spinal cord infection 19.35 11.73 10 87513 404 64410805
Agitated depression 19.30 11.73 9 87514 290 64410919
Arthritis 19.26 11.73 186 87337 83628 64327581
Disturbance in attention 19.19 11.73 108 87415 40966 64370243
Weight decreased 19.03 11.73 273 87250 285466 64125743
Bronchitis chronic 18.95 11.73 25 87498 3907 64407302
Analgesic drug level above therapeutic 18.91 11.73 10 87513 424 64410785
Haematoma 18.78 11.73 21 87502 46229 64364980
Skin discolouration 18.72 11.73 96 87427 35159 64376050
Adverse event 18.56 11.73 104 87419 39385 64371824
Sensory loss 18.55 11.73 42 87481 10127 64401082
Diabetes mellitus 18.52 11.73 39 87484 66435 64344774
Vestibular disorder 18.49 11.73 19 87504 2274 64408935
Derailment 18.48 11.73 6 87517 70 64411139
Logorrhoea 18.33 11.73 25 87498 4034 64407175
Myocardial fibrosis 18.30 11.73 16 87507 1564 64409645
Laboratory test abnormal 18.28 11.73 5 87518 24058 64387151
Visual acuity reduced 18.21 11.73 7 87516 27134 64384075
Duodenal ulcer perforation 18.18 11.73 94 87429 34531 64376678
Paradoxical psoriasis 18.11 11.73 7 87516 140 64411069
Thirst 18.06 11.73 51 87472 14086 64397123
Cold urticaria 17.92 11.73 5 87518 33 64411176
Injection site pruritus 17.88 11.73 15 87508 37811 64373398
Overgrowth bacterial 17.83 11.73 7 87516 146 64411063
Mycotic allergy 17.76 11.73 13 87510 985 64410224
Pneumonia 17.70 11.73 602 86921 558974 63852235
Perineal pain 17.70 11.73 13 87510 990 64410219
Pharyngeal swelling 17.60 11.73 29 87494 5530 64405679
Granuloma 17.57 11.73 32 87491 6609 64404600
Hyperkalaemia 17.55 11.73 74 87449 101055 64310154
Joint range of motion decreased 17.55 11.73 62 87461 19281 64391928
Dysmetropsia 17.42 11.73 6 87517 85 64411124
White blood cell count increased 17.34 11.73 40 87483 65974 64345235
Device related infection 17.32 11.73 10 87513 30616 64380593
Glaucoma 17.13 11.73 55 87468 16293 64394916
Myelodysplastic syndrome 17.09 11.73 8 87515 27571 64383638
Shock 17.07 11.73 16 87507 38224 64372985
Fear-related avoidance of activities 17.05 11.73 6 87517 91 64411118
Arteriosclerosis coronary artery 16.96 11.73 53 87470 15476 64395733
Head injury 16.83 11.73 12 87511 32830 64378379
Alice in wonderland syndrome 16.77 11.73 5 87518 43 64411166
Muscle rigidity 16.71 11.73 57 87466 17416 64393793
Soft tissue swelling 16.61 11.73 13 87510 1089 64410120
Skin lesion 16.60 11.73 15 87508 36467 64374742
Mite allergy 16.57 11.73 11 87512 712 64410497
Completed suicide 16.53 11.73 410 87113 224004 64187205
Dysphagia 16.26 11.73 82 87441 106730 64304479
Hypoxia 16.24 11.73 63 87460 88086 64323123
Abdominal discomfort 16.19 11.73 342 87181 181980 64229229
Intentional overdose 16.17 11.73 190 87333 89754 64321455
Respiratory arrest 16.05 11.73 125 87398 52860 64358349
Lip dry 16.03 11.73 26 87497 4892 64406317
Cholesteatoma 15.90 11.73 6 87517 112 64411097
Blood urea increased 15.88 11.73 22 87501 44131 64367078
Facet joint syndrome 15.72 11.73 16 87507 1893 64409316
Tuberculosis 15.65 11.73 46 87477 12992 64398217
Staphylococcal infection 15.62 11.73 28 87495 50650 64360559
Red blood cell count decreased 15.58 11.73 26 87497 48360 64362849
Pulmonary congestion 15.56 11.73 69 87454 23811 64387398
Mania 15.47 11.73 53 87470 16233 64394976
Hypertensive crisis 15.43 11.73 3 87520 18245 64392964
Coma 15.27 11.73 184 87339 87431 64323778
Prostate cancer 15.25 11.73 4 87519 19791 64391418
Underdose 15.24 11.73 8 87515 25821 64385388
No adverse event 15.21 11.73 10 87513 28551 64382658
Postmortem blood drug level abnormal 15.21 11.73 10 87513 637 64410572
Procedural anxiety 15.18 11.73 10 87513 639 64410570
Allergy to chemicals 15.13 11.73 12 87511 1025 64410184
Analgesic drug level increased 15.12 11.73 17 87506 2253 64408956
Pseudomonas infection 15.00 11.73 3 87520 17880 64393329
Mitral valve incompetence 14.93 11.73 8 87515 25530 64385679
Full blood count decreased 14.86 11.73 6 87517 22576 64388633
Red blood cell nucleated morphology present 14.81 11.73 4 87519 23 64411186
Myopathy 14.76 11.73 3 87520 17677 64393532
Malaise 14.75 11.73 668 86855 395579 64015630
Sinusitis 14.64 11.73 127 87396 145801 64265408
Blood lactate dehydrogenase increased 14.58 11.73 14 87509 33064 64378145
Haematochezia 14.56 11.73 44 87479 66329 64344880
Muscular weakness 14.54 11.73 107 87416 127231 64283978
Sciatica 14.32 11.73 60 87463 20204 64391005
Knee deformity 14.31 11.73 11 87512 897 64410312
Hypoglycaemia 14.26 11.73 68 87455 89824 64321385
Snoring 14.25 11.73 24 87499 4658 64406551
Supraventricular tachycardia 14.23 11.73 4 87519 18903 64392306
Laryngeal dyspnoea 14.19 11.73 7 87516 256 64410953
Chest pain 14.15 11.73 230 87293 235750 64175459
Pulmonary oedema 14.05 11.73 166 87357 78508 64332701
Anti-cyclic citrullinated peptide antibody 14.05 11.73 13 87510 1369 64409840
Product name confusion 13.99 11.73 6 87517 158 64411051
Tricuspid valve incompetence 13.96 11.73 3 87520 17000 64394209
Food allergy 13.85 11.73 32 87491 7819 64403390
Sinus disorder 13.84 11.73 3 87520 16905 64394304
Tendon operation 13.82 11.73 7 87516 271 64410938
Benign breast neoplasm 13.80 11.73 10 87513 746 64410463
Limb operation 13.73 11.73 18 87505 2796 64408413
Tubulointerstitial nephritis 13.72 11.73 13 87510 30896 64380313
Blood creatinine increased 13.69 11.73 118 87405 135664 64275545
Idiopathic pulmonary fibrosis 13.65 11.73 21 87502 3779 64407430
Needle fatigue 13.61 11.73 9 87514 579 64410630
Post procedural complication 13.53 11.73 6 87517 21347 64389862
Diabetes mellitus inadequate control 13.50 11.73 6 87517 21315 64389894
Blood pressure systolic decreased 13.47 11.73 34 87489 8786 64402423
Swelling face 13.44 11.73 131 87392 59035 64352174
Hand deformity 13.30 11.73 137 87386 62634 64348575
Joint stiffness 13.25 11.73 13 87510 30391 64380818
Tachypnoea 13.24 11.73 10 87513 26561 64384648
Myelosuppression 13.17 11.73 8 87515 23822 64387387
Confusional state 13.16 11.73 455 87068 260689 64150520
Splenomegaly 13.15 11.73 4 87519 17957 64393252
Tumour lysis syndrome 13.07 11.73 5 87518 19435 64391774
Gastritis fungal 13.05 11.73 6 87517 187 64411022
Depression 12.95 11.73 173 87350 183118 64228091
Cyanosis 12.95 11.73 62 87461 22093 64389116
Gastrointestinal haemorrhage 12.90 11.73 116 87407 132196 64279013
Hernia 12.84 11.73 44 87479 13474 64397735
Device malfunction 12.78 11.73 4 87519 17629 64393580
Retinal degeneration 12.75 11.73 11 87512 1056 64410153
Blood potassium decreased 12.74 11.73 22 87501 40377 64370832
Product quality issue 12.69 11.73 13 87510 29786 64381423
Nephropathy toxic 12.64 11.73 4 87519 17510 64393699
Nail bed tenderness 12.61 11.73 7 87516 327 64410882
Sleep disorder 12.50 11.73 130 87393 59579 64351630
Acute respiratory distress syndrome 12.46 11.73 21 87502 38914 64372295
Blood triglycerides increased 12.44 11.73 5 87518 18861 64392348
Hypertonic bladder 12.43 11.73 19 87504 3399 64407810
Distributive shock 12.42 11.73 14 87509 1861 64409348
Surgery 12.37 11.73 12 87511 28201 64383008
Status epilepticus 12.35 11.73 7 87516 21656 64389553
Renal disorder 12.34 11.73 18 87505 35347 64375862
Opiates positive 12.27 11.73 10 87513 888 64410321
Posterior reversible encephalopathy syndrome 12.27 11.73 8 87515 22938 64388271
Blood calcium decreased 12.25 11.73 10 87513 25544 64385665
Pulmonary function test abnormal 12.09 11.73 18 87505 3146 64408063
Increased bronchial secretion 12.08 11.73 17 87506 2825 64408384
Salt craving 12.07 11.73 4 87519 50 64411159
Ischaemic stroke 11.99 11.73 13 87510 29022 64382187
Polyneuropathy 11.98 11.73 6 87517 19888 64391321
Gastrointestinal stoma output increased 11.95 11.73 6 87517 228 64410981
Bradykinesia 11.86 11.73 27 87496 6533 64404676
Pneumocystis jirovecii pneumonia 11.83 11.73 12 87511 27622 64383587

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC N02AA59 NERVOUS SYSTEM
ANALGESICS
OPIOIDS
Natural opium alkaloids
ATC N02AA79 NERVOUS SYSTEM
ANALGESICS
OPIOIDS
Natural opium alkaloids
ATC N02AJ06 NERVOUS SYSTEM
ANALGESICS
OPIOIDS
Opioids in combination with non-opioid analgesics
ATC N02AJ07 NERVOUS SYSTEM
ANALGESICS
OPIOIDS
Opioids in combination with non-opioid analgesics
ATC N02AJ08 NERVOUS SYSTEM
ANALGESICS
OPIOIDS
Opioids in combination with non-opioid analgesics
ATC N02AJ09 NERVOUS SYSTEM
ANALGESICS
OPIOIDS
Opioids in combination with non-opioid analgesics
ATC R05DA04 RESPIRATORY SYSTEM
COUGH AND COLD PREPARATIONS
COUGH SUPPRESSANTS, EXCL. COMBINATIONS WITH EXPECTORANTS
Opium alkaloids and derivatives
MeSH PA D000700 Analgesics
MeSH PA D000701 Analgesics, Opioid
MeSH PA D000996 Antitussive Agents
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 D019141 Respiratory System Agents
MeSH PA D018689 Sensory System Agents
FDA MoA N0000175684 Full Opioid Agonists
FDA EPC N0000175690 Opioid Agonist
CHEBI has role CHEBI:35482 narcotic analgesic
CHEBI has role CHEBI:35703 Xenobiotic
CHEBI has role CHEBI:50266 Prodrugs
CHEBI has role CHEBI:51177 anti-tussive
CHEBI has role CHEBI:60606 opioid agonist
CHEBI has role CHEBI:78298 environmental contaminants
CHEBI has role CHEBI:88188 allergenic drug

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

DiseaseRelationSNOMED_IDDOID
Pain indication 22253000
Cough indication 49727002
Allergic rhinitis indication 61582004
Nasal discharge indication 64531003
Nasal congestion indication 68235000
Rhinitis indication 70076002 DOID:4483
Sneezing indication 76067001
Common cold indication 82272006 DOID:10459
Headache disorder indication 230461009
Sore throat symptom indication 267102003
Influenza-like symptoms indication 315642008
Fever indication 386661006
Tension-type headache indication 398057008
Muscle Spasm with Pain indication
Diarrhea off-label use 62315008
Necrotizing enterocolitis in fetus OR newborn contraindication 2707005
Goiter contraindication 3716002 DOID:12176
Ocular hypertension contraindication 4210003 DOID:9282
Gastritis contraindication 4556007 DOID:4029
Suicidal thoughts contraindication 6471006
Dependent drug abuse contraindication 6525002
Alcoholism contraindication 7200002
Alcohol withdrawal delirium contraindication 8635005
Hyperammonemia contraindication 9360008
Peptic ulcer contraindication 13200003 DOID:750
Chronic obstructive lung disease contraindication 13645005 DOID:3083
Asthenia contraindication 13791008
Hepatic encephalopathy contraindication 13920009 DOID:13413
Hyperkalemia contraindication 14140009
Constipation contraindication 14760008 DOID:2089
Hyperbilirubinemia contraindication 14783006 DOID:2741
Neuroleptic malignant syndrome contraindication 15244003 DOID:14464
Chronic disease of respiratory system contraindication 17097001
Mood swings contraindication 18963009
Lowered convulsive threshold contraindication 19260006
Hashimoto thyroiditis contraindication 21983002
Myocardial infarction contraindication 22298006 DOID:5844
Disorder of the central nervous system contraindication 23853001 DOID:331
Inflammatory bowel disease contraindication 24526004 DOID:0050589
Ventricular tachycardia contraindication 25569003
Acute tuberculosis contraindication 25629007
Alcohol intoxication contraindication 25702006
Shock contraindication 27942005
Hypercapnia contraindication 29596007
Bronchitis contraindication 32398004 DOID:6132
Dehydration contraindication 34095006
Hyperthyroidism contraindication 34486009 DOID:7998
Depressive disorder contraindication 35489007
Acute hepatitis contraindication 37871000
Hypertensive disorder contraindication 38341003 DOID:10763
Disorder of gallbladder contraindication 39621005 DOID:0060262
Gastrointestinal ulcer contraindication 40845000
Hypothyroidism contraindication 40930008 DOID:1459
Body fluid retention contraindication 43498006
Hyperactive behavior contraindication 44548000
Conduction disorder of the heart contraindication 44808001
Low blood pressure contraindication 45007003
Chronic heart failure contraindication 48447003
Bradycardia contraindication 48867003
Disorder of cardiovascular system contraindication 49601007 DOID:1287
Acidosis contraindication 51387008
Vitamin K deficiency contraindication 52675005 DOID:11249
Nasal polyp contraindication 52756005
Coronary arteriosclerosis contraindication 53741008 DOID:3393
Acute nephropathy contraindication 58574008
Hepatic failure contraindication 59927004
Ulcerative colitis contraindication 64766004 DOID:8577
Blood coagulation disorder contraindication 64779008 DOID:1247
Arterial thrombosis contraindication 65198009
Drug AND/OR toxin-induced diarrhea contraindication 65979008
Substance abuse contraindication 66214007
Benign intracranial hypertension contraindication 68267002 DOID:11459
Psychotic disorder contraindication 69322001
Poisoning by acetaminophen contraindication 70273001
Agoraphobia contraindication 70691001 DOID:593
Arteriosclerotic vascular disease contraindication 72092001
Sedation contraindication 72641008
Hepatic coma contraindication 72836002 DOID:12550
Diabetes mellitus contraindication 73211009 DOID:9351
Sleep apnea contraindication 73430006 DOID:0050847
Factor II deficiency contraindication 73975000
Reye's syndrome contraindication 74351001 DOID:14525
Gastrointestinal hemorrhage contraindication 74474003
Urethral stricture contraindication 76618002
Thrombotic thrombocytopenic purpura contraindication 78129009 DOID:10772
Decreased respiratory function contraindication 80954004
Disorder of brain contraindication 81308009 DOID:936
Injury of head contraindication 82271004
Chronic idiopathic constipation contraindication 82934008
Cor pulmonale contraindication 83291003 DOID:8515
Epilepsy contraindication 84757009 DOID:1826
Pulmonary emphysema contraindication 87433001
Gout contraindication 90560007 DOID:13189
Kidney disease contraindication 90708001 DOID:557
Thyrotoxicosis contraindication 90739004 DOID:7997
Hemophilia contraindication 90935002
Dermatitis herpetiformis contraindication 111196000 DOID:8505
Anemia due to enzyme deficiency contraindication 111577008
Acute abdominal pain contraindication 116290004
Procedure on urinary system contraindication 118677009
Gastrointestinal obstruction contraindication 126765001
Neoplasm of brain contraindication 126952004 DOID:1319
von Willebrand disorder contraindication 128105004 DOID:12531
Seizure disorder contraindication 128613002
Drug-induced psychosis contraindication 191483003 DOID:1742
Obsessive-compulsive disorder contraindication 191736004 DOID:10933
Insomnia contraindication 193462001
Partial atrioventricular block contraindication 195039008
Acute pancreatitis contraindication 197456007 DOID:2913
Impaired renal function disorder contraindication 197663003
Acute intermittent porphyria contraindication 234422006 DOID:3890
Gastroesophageal reflux disease contraindication 235595009 DOID:8534
Disease of liver contraindication 235856003 DOID:409
Bladder outflow obstruction contraindication 236645006
Morbid obesity contraindication 238136002 DOID:11981
Hypocomplementemic urticarial vasculitis contraindication 239945009
Pyloric obstruction contraindication 244815007
Sleep automatism contraindication 247962006
Benign prostatic hyperplasia contraindication 266569009
Retention of urine contraindication 267064002
Anemia contraindication 271737000 DOID:2355
Exacerbation of asthma contraindication 281239006
Pregnancy, function contraindication 289908002
Lesion of brain contraindication 301766008
Thrombocytopenic disorder contraindication 302215000 DOID:1588
Neutropenic disorder contraindication 303011007 DOID:1227
Bone marrow depression contraindication 307762000
Panic disorder contraindication 371631005 DOID:594
Coma contraindication 371632003
Primary adrenocortical insufficiency contraindication 373662000
Operation on gastrointestinal tract contraindication 386621005
Hypoxia contraindication 389086002
Angle-closure glaucoma contraindication 392291006 DOID:13550
Cardiovascular event risk contraindication 395112001
Pseudomembranous enterocolitis contraindication 397683000
Respiratory insufficiency contraindication 409623005
Breastfeeding (mother) contraindication 413712001
Chronic myocardial ischemia contraindication 413844008 DOID:3393
Disorder of coronary artery contraindication 414024009
Myocardial ischemia contraindication 414795007 DOID:3393
Myocardial infarction in recovery phase contraindication 418044006
Central nervous system depression contraindication 418072004
Porphyria contraindication 418470004
Ultrarapid metabolizer due to cytochrome p450 CYP2D6 variant contraindication 422681000
Poor metabolizer due to cytochrome p450 CYP2C19 variant contraindication 424500005
Dysfunction of sphincter of Oddi contraindication 430887001
Hypertensive urgency contraindication 443482000
Acute erosive gastritis contraindication 444926003
Acute exacerbation of asthma contraindication 708038006




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 8.38 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
8MG;54.3MG TUXARIN ER MAINPOINTE N206323 June 22, 2015 RX TABLET, EXTENDED RELEASE ORAL 9066942 Jan. 3, 2032 TREATMENT OF COUGH AND SYMPTOMS ASSOCIATED WITH UPPER RESPIRATORY ALLERGIES OR A COMMON COLD WITH CODEINE PHOSPHATE AND CHLORPHENIRAMINE MALEATE ORALLY ADMINISTERED EXTENDED RELEASE TABLETS

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 Ki 6.14 CHEMBL CHEMBL
Kappa-type opioid receptor GPCR AGONIST Ki 4.59 CHEMBL
Delta-type opioid receptor GPCR AGONIST Ki 4.28 CHEMBL
Opioid receptor GPCR IC50 8 CHEMBL

External reference:

IDSource
4017509 VUID
N0000145894 NUI
D00195 KEGG_DRUG
41444-62-6 SECONDARY_CAS_RN
6854-40-6 SECONDARY_CAS_RN
1545976 RXNORM
4017414 VANDF
4017415 VANDF
4017509 VANDF
4019491 VANDF
C0009214 UMLSCUI
CHEBI:16714 CHEBI
CHEMBL485 ChEMBL_ID
CHEMBL369475 ChEMBL_ID
CHEMBL1201099 ChEMBL_ID
DB00318 DRUGBANK_ID
CHEMBL1159819 ChEMBL_ID
CHEMBL4297091 ChEMBL_ID
CHEMBL284671 ChEMBL_ID
D003061 MESH_DESCRIPTOR_UI
5284371 PUBCHEM_CID
1673 IUPHAR_LIGAND_ID
Q830PW7520 UNII
32159 MMSL
4490 MMSL
4491 MMSL
4492 MMSL
4675 MMSL
4676 MMSL
d00012 MMSL
001550 NDDF
001551 NDDF
001552 NDDF
001553 NDDF
005189 NDDF
1476002 SNOMEDCT_US
261000 SNOMEDCT_US
387494007 SNOMEDCT_US
85990009 SNOMEDCT_US
CHEMBL1201463 ChEMBL_ID
6059-47-8 SECONDARY_CAS_RN
52-28-8 SECONDARY_CAS_RN

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Fiorinal with Codeine HUMAN PRESCRIPTION DRUG LABEL 4 0023-6010 CAPSULE 30 mg ORAL NDA 36 sections
Codeine sulfate HUMAN PRESCRIPTION DRUG LABEL 1 0054-0243 TABLET 15 mg ORAL NDA 32 sections
Codeine sulfate HUMAN PRESCRIPTION DRUG LABEL 1 0054-0244 TABLET 30 mg ORAL NDA 32 sections
Codeine sulfate HUMAN PRESCRIPTION DRUG LABEL 1 0054-0245 TABLET 60 mg ORAL NDA 32 sections
Butalbital, Acetaminophen, Caffeine and Codeine Phosphate HUMAN PRESCRIPTION DRUG LABEL 4 0054-0650 CAPSULE 30 mg ORAL ANDA 33 sections
Butalbital, Acetaminophen, Caffeine and Codeine Phosphate HUMAN PRESCRIPTION DRUG LABEL 4 0054-3000 CAPSULE 30 mg ORAL ANDA 33 sections
Acetaminophen and Codeine Phosphate HUMAN PRESCRIPTION DRUG LABEL 2 0093-0050 TABLET 15 mg ORAL ANDA 27 sections
Acetaminophen and Codeine Phosphate HUMAN PRESCRIPTION DRUG LABEL 2 0093-0050 TABLET 15 mg ORAL ANDA 27 sections
Acetaminophen and Codeine Phosphate HUMAN PRESCRIPTION DRUG LABEL 2 0093-0150 TABLET 30 mg ORAL ANDA 27 sections
Acetaminophen and Codeine Phosphate HUMAN PRESCRIPTION DRUG LABEL 2 0093-0150 TABLET 30 mg ORAL ANDA 27 sections
Acetaminophen and Codeine Phosphate HUMAN PRESCRIPTION DRUG LABEL 2 0093-0350 TABLET 60 mg ORAL ANDA 27 sections
Acetaminophen and Codeine Phosphate HUMAN PRESCRIPTION DRUG LABEL 2 0093-0350 TABLET 60 mg ORAL ANDA 27 sections
Acetaminophen and Codeine Phosphate HUMAN PRESCRIPTION DRUG LABEL 2 0121-0504 SOLUTION 12 mg ORAL ANDA 34 sections
PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE HUMAN PRESCRIPTION DRUG LABEL 2 0121-0547 SYRUP 10 mg ORAL ANDA 30 sections
Guaifenesin and Codeine Phosphate HUMAN OTC DRUG LABEL 2 0121-0775 SOLUTION 10 mg ORAL OTC monograph final 16 sections
Guaifenesin and Codeine Phosphate HUMAN OTC DRUG LABEL 2 0121-0775 SOLUTION 10 mg ORAL OTC monograph final 16 sections
Promethazine VC with Codeine Oral Solution HUMAN PRESCRIPTION DRUG LABEL 3 0121-0925 SOLUTION 10 mg ORAL ANDA 29 sections
Promethazine with Codeine HUMAN PRESCRIPTION DRUG LABEL 2 0121-0928 SOLUTION 10 mg ORAL ANDA 29 sections
Acetaminophen and Codeine Phosphate HUMAN PRESCRIPTION DRUG LABEL 2 0121-1008 SOLUTION 30 mg ORAL ANDA 34 sections
Guaifenesin and Codeine Phosphate HUMAN OTC DRUG LABEL 2 0121-1550 SOLUTION 10 mg ORAL OTC monograph final 16 sections
Guaifenesin and Codeine Phosphate HUMAN OTC DRUG LABEL 2 0121-1550 SOLUTION 20 mg ORAL OTC monograph final 16 sections
Guaifenesin and Codeine Phosphate HUMAN OTC DRUG LABEL 2 0121-1775 SOLUTION 10 mg ORAL OTC monograph final 16 sections
Guaifenesin and Codeine Phosphate HUMAN OTC DRUG LABEL 2 0121-1775 SOLUTION 10 mg ORAL OTC monograph final 16 sections
ACETAMINOPHEN AND CODEINE PHOSPHATE HUMAN PRESCRIPTION DRUG LABEL 2 0406-0483 TABLET 15 mg ORAL ANDA 15 sections
ACETAMINOPHEN AND CODEINE PHOSPHATE HUMAN PRESCRIPTION DRUG LABEL 2 0406-0484 TABLET 30 mg ORAL ANDA 15 sections
ACETAMINOPHEN AND CODEINE PHOSPHATE HUMAN PRESCRIPTION DRUG LABEL 2 0406-0485 TABLET 60 mg ORAL ANDA 15 sections
Acetaminophen And Codeine HUMAN PRESCRIPTION DRUG LABEL 2 0440-7026 TABLET 30 mg ORAL ANDA 31 sections
Acetaminophen And Codeine HUMAN PRESCRIPTION DRUG LABEL 2 0440-7027 TABLET 60 mg ORAL ANDA 31 sections
Butalbital, Aspirin, Caffeine and Codeine Phosphate HUMAN PRESCRIPTION DRUG LABEL 4 0527-1312 CAPSULE 30 mg ORAL ANDA 25 sections
Codeine Sulfate HUMAN PRESCRIPTION DRUG LABEL 1 0527-1698 TABLET 30 mg ORAL ANDA 32 sections