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 5587.83 12.42 4657 116967 306030 63061368
Blood parathyroid hormone decreased 512.25 12.42 286 121338 9505 63357893
Panniculitis 474.73 12.42 287 121337 11098 63356300
Granuloma skin 470.36 12.42 257 121367 8180 63359218
Rheumatoid arthritis 464.47 12.42 1297 120327 252522 63114876
Rheumatoid nodule 416.64 12.42 309 121315 16846 63350552
Skin necrosis 379.13 12.42 269 121355 13681 63353717
Drug intolerance 331.93 12.42 1318 120306 307343 63060055
Hypercalcaemia 288.31 12.42 312 121312 28010 63339388
Toxicity to various agents 277.11 12.42 1070 120554 246180 63121218
Ulcer 271.72 12.42 291 121333 25816 63341582
Basal cell carcinoma 268.70 12.42 299 121325 27692 63339706
Drug eruption 250.84 12.42 292 121332 28402 63338996
Contrast media allergy 247.02 12.42 111 121513 2290 63365108
Skin ulcer 246.00 12.42 355 121269 42690 63324708
Inflammation 226.15 12.42 492 121132 81781 63285617
Tenosynovitis 215.30 12.42 192 121432 13603 63353795
Product dose omission issue 203.77 12.42 97 121527 234216 63133182
Red blood cell sedimentation rate increased 203.67 12.42 329 121295 43653 63323745
Contraindicated product administered 192.92 12.42 877 120747 216771 63150627
C-reactive protein abnormal 189.64 12.42 327 121297 45769 63321629
Drug tolerance decreased 187.54 12.42 198 121426 17275 63350123
Drug abuse 175.12 12.42 412 121212 72106 63295292
Fibromyalgia 173.01 12.42 437 121187 79983 63287415
Rash pruritic 170.47 12.42 363 121261 59436 63307962
Therapeutic product effect decreased 157.60 12.42 760 120864 192427 63174971
Musculoskeletal stiffness 154.00 12.42 731 120893 183887 63183511
C-reactive protein increased 151.59 12.42 462 121162 94245 63273153
Treatment failure 140.59 12.42 752 120872 198291 63169107
Fall 140.21 12.42 343 121281 391991 62975407
Enthesopathy 138.62 12.42 122 121502 8492 63358906
Infusion related reaction 138.57 12.42 874 120750 244647 63122751
Blood cholesterol increased 135.16 12.42 442 121182 93590 63273808
Peripheral swelling 133.90 12.42 920 120704 265022 63102376
Loss of personal independence in daily activities 133.33 12.42 450 121174 96840 63270558
Psoriatic arthropathy 131.37 12.42 430 121194 91090 63276308
Urinary tract infection 124.20 12.42 197 121427 264487 63102911
Deep vein thrombosis postoperative 115.24 12.42 125 121499 11244 63356154
White blood cell count abnormal 113.87 12.42 95 121529 6147 63361251
Tongue disorder 113.72 12.42 120 121504 10460 63356938
Substance abuse 113.15 12.42 85 121539 4722 63362676
Bursitis 111.54 12.42 230 121394 36811 63330587
Soft tissue disorder 110.37 12.42 81 121543 4341 63363057
Red blood cell sedimentation rate 110.20 12.42 84 121540 4770 63362628
Deformity 107.30 12.42 122 121502 11562 63355836
Lip dry 107.06 12.42 140 121484 15330 63352068
Gastric pH decreased 106.66 12.42 44 121580 730 63366668
COVID-19 105.88 12.42 42 121582 113061 63254337
Synovitis 104.51 12.42 664 120960 186254 63181144
Joint swelling 100.63 12.42 1014 120610 326652 63040746
Hypercholesterolaemia 97.93 12.42 159 121465 21175 63346223
Pancytopenia 97.52 12.42 32 121592 96901 63270497
Derealisation 96.85 12.42 47 121577 1161 63366237
Mobility decreased 95.37 12.42 472 121152 120687 63246711
Facet joint syndrome 95.33 12.42 117 121507 12021 63355377
Peripheral venous disease 91.85 12.42 130 121494 15347 63352051
Musculoskeletal disorder 90.91 12.42 151 121473 20493 63346905
Duodenal ulcer perforation 88.27 12.42 366 121258 86843 63280555
Injection site erythema 88.11 12.42 25 121599 83149 63284249
Hypotension 86.17 12.42 253 121371 272351 63095047
Rheumatoid factor positive 86.02 12.42 355 121269 84051 63283347
Tendonitis 83.08 12.42 141 121483 19474 63347924
Autoimmune disorder 82.93 12.42 131 121493 17046 63350352
Depersonalisation/derealisation disorder 82.62 12.42 44 121580 1328 63366070
Joint range of motion decreased 82.37 12.42 188 121436 32240 63335158
Musculoskeletal pain 79.48 12.42 369 121255 91908 63275490
Anaemia 79.17 12.42 292 121332 293138 63074260
Dehydration 78.47 12.42 132 121492 173222 63194176
H1N1 influenza 78.10 12.42 46 121578 1693 63365705
Injection site pain 78.05 12.42 80 121544 129720 63237678
Obliterative bronchiolitis 77.63 12.42 49 121575 2046 63365352
Liver injury 75.99 12.42 272 121352 60248 63307150
Hypersensitivity 75.08 12.42 874 120750 291811 63075587
Prescribed overdose 74.87 12.42 187 121437 33966 63333432
Herpes zoster 73.43 12.42 333 121291 82129 63285269
Helicobacter infection 72.66 12.42 361 121263 92424 63274974
Rash 71.69 12.42 1488 120136 559383 62808015
Neutropenia 71.42 12.42 142 121482 174863 63192535
Renal failure 71.32 12.42 72 121552 117580 63249818
Rheumatic fever 70.52 12.42 212 121412 42899 63324499
Product use issue 70.30 12.42 688 120936 219832 63147566
Cogwheel rigidity 67.85 12.42 44 121580 1926 63365472
Loss of employment 67.34 12.42 46 121578 2198 63365200
Disease progression 66.87 12.42 82 121542 122676 63244722
Acute kidney injury 65.99 12.42 270 121354 263145 63104253
Overdose 65.62 12.42 411 121213 114667 63252731
Urticaria 65.48 12.42 542 121082 165260 63202138
Platelet count decreased 63.85 12.42 77 121547 116045 63251353
Feeling of despair 63.30 12.42 45 121579 2294 63365104
Sepsis 61.83 12.42 125 121499 152998 63214400
Alanine aminotransferase increased 61.29 12.42 374 121250 103396 63264002
Alanine aminotransferase abnormal 61.15 12.42 58 121566 4446 63362952
Adverse event 60.27 12.42 273 121351 67286 63300112
Death 60.11 12.42 445 121179 373936 62993462
Asphyxia 59.25 12.42 66 121558 6115 63361283
Dissociation 58.65 12.42 47 121577 2872 63364526
Gastric disorder 58.53 12.42 181 121443 37188 63330210
Fatigue 56.94 12.42 1283 120341 886745 62480653
Feeling of body temperature change 55.24 12.42 57 121567 4840 63362558
Anaphylactic reaction 55.20 12.42 262 121362 65838 63301560
Arthropathy 54.86 12.42 689 120935 234103 63133295
Neuropathy peripheral 54.77 12.42 83 121541 113584 63253814
Device expulsion 54.60 12.42 3 121621 34919 63332479
Hepatic enzyme increased 53.98 12.42 609 121015 201719 63165679
Drug dependence 52.56 12.42 133 121491 24350 63343048
Lower respiratory tract infection 52.48 12.42 433 121191 131874 63235524
Miosis 51.59 12.42 67 121557 7286 63360112
Asthenia 51.56 12.42 478 121146 383126 62984272
Aspartate aminotransferase increased 51.19 12.42 322 121302 89955 63277443
Type 2 diabetes mellitus 51.06 12.42 250 121374 63618 63303780
Injection site swelling 50.93 12.42 14 121610 47558 63319840
Wrong technique in product usage process 50.84 12.42 28 121596 62312 63305086
Therapy interrupted 50.09 12.42 3 121621 32452 63334946
Drug tolerance 49.82 12.42 64 121560 6885 63360513
Sciatica 48.97 12.42 161 121463 34163 63333235
Cerebrovascular accident 48.17 12.42 83 121541 107941 63259457
Atrial fibrillation 48.12 12.42 94 121530 116542 63250856
Obesity 46.84 12.42 145 121479 29807 63337591
Anti-cyclic citrullinated peptide antibody 46.51 12.42 61 121563 6697 63360701
Full blood count abnormal 45.89 12.42 4 121620 31713 63335685
Therapy non-responder 45.72 12.42 275 121349 75626 63291772
White blood cell count decreased 45.44 12.42 127 121497 138977 63228421
Hospitalisation 45.11 12.42 58 121566 85023 63282375
No adverse event 44.67 12.42 12 121612 41393 63326005
Injury 44.51 12.42 266 121358 72981 63294417
Chronic obstructive pulmonary disease 44.49 12.42 33 121591 62653 63304745
Wrist surgery 44.24 12.42 25 121599 850 63366548
Hallucinations, mixed 43.62 12.42 50 121574 4779 63362619
Drooling 43.59 12.42 45 121579 3823 63363575
Respiratory depression 43.46 12.42 87 121537 13628 63353770
Haematocrit decreased 43.21 12.42 11 121613 39329 63328069
Patient uncooperative 43.19 12.42 16 121608 196 63367202
Serotonin syndrome 43.14 12.42 137 121487 28545 63338853
Haemoglobin decreased 43.08 12.42 139 121485 145346 63222052
Toxicologic test abnormal 43.07 12.42 23 121601 698 63366700
Neutropenic sepsis 42.52 12.42 96 121528 16342 63351056
Muscle disorder 42.46 12.42 50 121574 4919 63362479
Fear of injection 42.25 12.42 60 121564 7104 63360294
Injection site pruritus 41.80 12.42 17 121607 45099 63322299
Paralysis 41.70 12.42 71 121553 9829 63357569
Multiple sclerosis relapse 40.67 12.42 21 121603 48457 63318941
Unevaluable event 40.59 12.42 24 121600 51362 63316036
Respiratory failure 40.38 12.42 84 121540 101774 63265624
Blood potassium decreased 40.32 12.42 15 121609 42011 63325387
Mental status changes 39.94 12.42 13 121611 39586 63327812
Pulmonary hypertension 39.60 12.42 11 121613 37112 63330286
Pulmonary embolism 39.25 12.42 105 121519 116579 63250819
Hypokalaemia 39.16 12.42 88 121536 103716 63263682
Acute respiratory failure 39.14 12.42 9 121615 34476 63332922
Visceral congestion 39.11 12.42 17 121607 323 63367075
Renal papillary necrosis 39.09 12.42 16 121608 260 63367138
Pneumonia viral 39.05 12.42 61 121563 7861 63359537
Poisoning deliberate 39.00 12.42 74 121550 11144 63356254
Pleural effusion 38.55 12.42 75 121549 93135 63274263
Swollen tongue 38.34 12.42 150 121474 34650 63332748
C-reactive protein 38.24 12.42 47 121577 4835 63362563
Pancreatic fibrosis 38.08 12.42 12 121612 86 63367312
Febrile neutropenia 38.05 12.42 109 121515 118340 63249058
Pulmonary fibrosis 37.87 12.42 164 121460 39645 63327753
Blister 37.01 12.42 396 121228 129418 63237980
Bone marrow failure 36.71 12.42 6 121618 29284 63338114
Therapeutic product ineffective 36.61 12.42 29 121595 1743 63365655
Delirium 36.31 12.42 192 121432 50349 63317049
Folliculitis 36.31 12.42 245 121379 70072 63297326
Schizophrenia 36.28 12.42 67 121557 9885 63357513
Swollen joint count increased 36.21 12.42 151 121473 35903 63331495
Pericarditis 35.95 12.42 398 121226 131181 63236217
Renal impairment 35.76 12.42 72 121552 88283 63279115
Anti-cyclic citrullinated peptide antibody positive 35.25 12.42 359 121265 115853 63251545
Dyspnoea 35.08 12.42 982 120642 660331 62707067
Rheumatoid lung 35.03 12.42 40 121584 3808 63363590
Food allergy 34.55 12.42 71 121553 11330 63356068
Bradypnoea 34.19 12.42 38 121586 3512 63363886
Premature delivery 34.17 12.42 8 121616 30273 63337125
Necrosis ischaemic 34.10 12.42 21 121603 839 63366559
Adjustment disorder with depressed mood 33.87 12.42 66 121558 10138 63357260
Transient ischaemic attack 33.74 12.42 15 121609 37738 63329660
Dry mouth 33.68 12.42 260 121364 77603 63289795
Allergy to chemicals 33.58 12.42 35 121589 3007 63364391
Accidental exposure to product 33.49 12.42 6 121618 27399 63339999
Depression 33.20 12.42 230 121394 196262 63171136
Hypoglycaemia 32.82 12.42 40 121584 60025 63307373
Hypertension 32.63 12.42 732 120892 278571 63088827
Lung disorder 32.18 12.42 217 121407 62044 63305354
Feeling jittery 32.16 12.42 76 121548 13327 63354071
Liver function test abnormal 31.89 12.42 179 121445 48002 63319396
Hand deformity 31.86 12.42 455 121169 159002 63208396
Sopor 31.52 12.42 3 121621 22161 63345237
Mydriasis 31.12 12.42 70 121554 11886 63355512
Haemorrhage 30.92 12.42 43 121581 60979 63306419
Sinus disorder 30.84 12.42 5 121619 24548 63342850
Hyperkalaemia 30.79 12.42 35 121589 54168 63313230
Menstrual disorder 30.60 12.42 44 121580 5269 63362129
Arthralgia 30.49 12.42 1358 120266 568352 62799046
Disease recurrence 30.47 12.42 8 121616 28022 63339376
Arthritis 30.46 12.42 348 121276 115573 63251825
Staphylococcal infection 30.22 12.42 21 121603 41235 63326163
Liver disorder 30.11 12.42 191 121433 53496 63313902
Deep vein thrombosis 30.04 12.42 73 121551 83727 63283671
Blood pressure systolic increased 30 12.42 174 121450 47223 63320175
Libido increased 29.93 12.42 23 121601 1322 63366076
Hyperglycaemia 29.76 12.42 22 121602 41845 63325553
Flushing 29.69 12.42 62 121562 75025 63292373
Body temperature decreased 29.60 12.42 96 121528 20223 63347175
Device issue 29.52 12.42 5 121619 23776 63343622
Parosmia 29.50 12.42 47 121577 6159 63361239
Fungal infection 29.44 12.42 17 121607 36857 63330541
Hypoxia 29.43 12.42 43 121581 59749 63307649
Lupus vulgaris 29.33 12.42 46 121578 5948 63361450
Wheezing 29.31 12.42 296 121328 95299 63272099
Muscle injury 29.27 12.42 220 121404 65125 63302273
Hypervolaemia 29.24 12.42 9 121615 28404 63338994
Full blood count decreased 29.12 12.42 7 121617 26017 63341381
Osteoarthritis 28.65 12.42 294 121330 95049 63272349
Diabetes mellitus 28.60 12.42 39 121585 55771 63311627
Chest discomfort 28.58 12.42 111 121513 109858 63257540
Pneumonia 28.52 12.42 662 120962 456105 62911293
Hypoaesthesia 28.07 12.42 466 121158 167927 63199471
Bradycardia 27.68 12.42 62 121562 73165 63294233
Head injury 27.62 12.42 9 121615 27387 63340011
Weight decreased 27.58 12.42 369 121255 276429 63090969
Thrombocytopenia 27.51 12.42 173 121451 150984 63216414
Chronic kidney disease 27.25 12.42 28 121596 45370 63322028
Night sweats 26.97 12.42 173 121451 48641 63318757
Cardiac failure congestive 26.88 12.42 89 121535 92344 63275054
Laboratory test abnormal 26.85 12.42 9 121615 26903 63340495
Sinusitis 26.83 12.42 291 121333 226362 63141036
Pericardial effusion 26.77 12.42 12 121612 30046 63337352
Cognitive disorder 26.64 12.42 41 121583 55774 63311624
Influenza like illness 26.57 12.42 55 121569 66769 63300629
Macular degeneration 26.42 12.42 7 121617 24369 63343029
Septic shock 26.36 12.42 55 121569 66574 63300824
Multiple organ dysfunction syndrome 25.85 12.42 43 121581 56709 63310689
Gait inability 25.84 12.42 182 121442 52777 63314621
Soft tissue injury 25.79 12.42 23 121601 1629 63365769
Lower limb fracture 25.55 12.42 103 121521 24118 63343280
Surgery 25.36 12.42 19 121605 35893 63331505
Swelling face 25.29 12.42 208 121416 63267 63304131
Granuloma 25.17 12.42 42 121582 5719 63361679
X-ray abnormal 25.16 12.42 51 121573 8059 63359339
Metastases to eye 24.92 12.42 10 121614 154 63367244
Temperature regulation disorder 24.55 12.42 43 121581 6089 63361309
Suicide attempt 24.34 12.42 50 121574 60868 63306530
Thrombosis 24.34 12.42 55 121569 64700 63302698
Prescribed underdose 24.29 12.42 117 121507 29572 63337826
Blood immunoglobulin M increased 24.24 12.42 19 121605 1124 63366274
Blood glucose increased 24.11 12.42 81 121543 83675 63283723
Agranulocytosis 24.06 12.42 9 121615 25125 63342273
Bronchitis 23.77 12.42 141 121483 124794 63242604
Cough 23.76 12.42 406 121218 292337 63075061
Hernia 23.62 12.42 65 121559 12509 63354889
Bone pain 23.44 12.42 43 121581 54598 63312800
Cardiomyopathy 23.43 12.42 3 121621 17581 63349817
Skin lesion 23.36 12.42 15 121609 30706 63336692
Synovial fluid analysis 23.35 12.42 26 121598 2407 63364991
Cholelithiasis 23.22 12.42 30 121594 43895 63323503
Post-traumatic neck syndrome 23.14 12.42 24 121600 2050 63365348
Tuberculosis 23.13 12.42 60 121564 11151 63356247
Acarodermatitis 22.97 12.42 18 121606 1065 63366333
Hip fracture 22.95 12.42 14 121610 29460 63337938
Oxygen saturation decreased 22.65 12.42 90 121534 88495 63278903
Tenosynovitis stenosans 22.59 12.42 30 121594 3334 63364064
Lymphopenia 22.42 12.42 4 121620 18323 63349075
Excessive eye blinking 22.36 12.42 19 121605 1261 63366137
Haematochezia 22.20 12.42 43 121581 53501 63313897
Eosinophilia 22.04 12.42 8 121616 22748 63344650
Dysphagia 22.02 12.42 91 121533 88494 63278904
Fear of eating 22.01 12.42 12 121612 380 63367018
Myelodysplastic syndrome 21.99 12.42 3 121621 16751 63350647
Irritable bowel syndrome 21.91 12.42 248 121376 82164 63285234
Duodenal ulcer repair 21.77 12.42 7 121617 54 63367344
Incontinence 21.72 12.42 60 121564 11572 63355826
Proteinuria 21.72 12.42 5 121619 19140 63348258
Scleritis 21.69 12.42 34 121590 4394 63363004
Gastrooesophageal reflux disease 21.50 12.42 102 121522 95537 63271861
Hostility 21.50 12.42 22 121602 1850 63365548
Sternal fracture 21.49 12.42 24 121600 2230 63365168
Lymphocyte count decreased 21.37 12.42 16 121608 30241 63337157
Nightmare 21.36 12.42 83 121541 19111 63348287
Electrolyte imbalance 21.32 12.42 6 121618 20070 63347328
Dyspnoea exertional 21.24 12.42 53 121571 60249 63307149
Foetal exposure during pregnancy 21.20 12.42 18 121606 31944 63335454
Blood pressure systolic decreased 21.17 12.42 45 121579 7352 63360046
Haematuria 21.14 12.42 15 121609 29142 63338256
Pyrexia 21.11 12.42 714 120910 469764 62897634
Soft tissue swelling 20.78 12.42 18 121606 1226 63366172
Leukocytosis 20.64 12.42 12 121612 25923 63341475
Accidental overdose 20.64 12.42 94 121530 23215 63344183
Oedema peripheral 20.59 12.42 248 121376 189263 63178135
Myocardial infarction 20.48 12.42 110 121514 99783 63267615
Acute myeloid leukaemia 20.43 12.42 4 121620 17143 63350255
Diaphragmatic rupture 20.42 12.42 10 121614 252 63367146
Mood swings 20.38 12.42 79 121545 18169 63349229
Post procedural complication 20.31 12.42 4 121620 17070 63350328
Pneumonia streptococcal 20.28 12.42 21 121603 1790 63365608
Spinal fracture 20.28 12.42 5 121619 18266 63349132
Blood pressure fluctuation 20.27 12.42 36 121588 46281 63321117
Treatment noncompliance 20.24 12.42 25 121599 37300 63330098
Hyperhidrosis 20.07 12.42 304 121320 107532 63259866
Dry skin 20.04 12.42 50 121574 56837 63310561
Infusion site pain 19.96 12.42 4 121620 16865 63350533
Blood immunoglobulin A decreased 19.89 12.42 18 121606 1299 63366099
Injection site bruising 19.80 12.42 31 121593 41879 63325519
Mycotic allergy 19.74 12.42 16 121608 994 63366404
Pharyngitis 19.64 12.42 7 121617 20136 63347262
Device malfunction 19.60 12.42 5 121619 17852 63349546
Abortion spontaneous 19.48 12.42 38 121586 47157 63320241
Hip arthroplasty 19.45 12.42 157 121467 47489 63319909
Coronary artery disease 19.40 12.42 20 121604 32357 63335041
Lactic acidosis 19.37 12.42 27 121597 38260 63329138
Ataxia 19.29 12.42 3 121621 15192 63352206
White blood cell count increased 19.28 12.42 40 121584 48521 63318877
Muscle rigidity 19.22 12.42 57 121567 11443 63355955
Haematoma 19.22 12.42 23 121601 34797 63332601
Transaminases increased 19.22 12.42 19 121605 31348 63336050
Alveolar rhabdomyosarcoma 19.15 12.42 5 121619 16 63367382
Chills 19.00 12.42 133 121491 113245 63254153
Visual acuity reduced 18.99 12.42 9 121615 21817 63345581
Feeling abnormal 18.99 12.42 187 121437 148205 63219193
Product storage error 18.88 12.42 3 121621 14953 63352445
Needle issue 18.86 12.42 53 121571 10323 63357075
Skin laceration 18.80 12.42 10 121614 22698 63344700
Encephalopathy 18.79 12.42 28 121596 38592 63328806
Abdominal discomfort 18.70 12.42 772 120852 320113 63047285
Dislocation of vertebra 18.63 12.42 47 121577 8588 63358810
Blood urea increased 18.57 12.42 14 121610 26365 63341033
Osteonecrosis of jaw 18.55 12.42 24 121600 35099 63332299
Emotional distress 18.51 12.42 21 121603 32528 63334870
Plasma cell myeloma 18.49 12.42 25 121599 35880 63331518
Erythema 18.47 12.42 454 121170 175297 63192101
Sleep disorder 18.43 12.42 238 121386 81328 63286070
Poisoning 18.42 12.42 63 121561 13637 63353761
Respiratory tract infection 18.37 12.42 32 121592 41451 63325947
Device related infection 18.37 12.42 11 121613 23381 63344017
Beta haemolytic streptococcal infection 18.35 12.42 21 121603 2004 63365394
Pulmonary function test abnormal 18.33 12.42 20 121604 1810 63365588
Burning sensation 18.26 12.42 49 121575 54358 63313040
Respiratory distress 18.14 12.42 23 121601 33928 63333470
Restless legs syndrome 18.13 12.42 77 121547 18454 63348944
Presyncope 18.00 12.42 16 121608 27769 63339629
Cerebral infarction 17.71 12.42 12 121612 23881 63343517
Hypoaesthesia oral 17.58 12.42 60 121564 12973 63354425
Upper respiratory tract infection 17.54 12.42 237 121387 81810 63285588
Influenza 17.50 12.42 129 121495 108593 63258805
Laryngeal dyspnoea 17.50 12.42 8 121616 172 63367226
Postmortem blood drug level abnormal 17.48 12.42 10 121614 348 63367050
Incubator therapy 17.47 12.42 6 121618 58 63367340
Derailment 17.38 12.42 6 121618 59 63367339
Neutrophil count decreased 17.31 12.42 53 121571 56353 63311045
Cerebral haemorrhage 17.28 12.42 20 121604 30709 63336689
Hot flush 17.22 12.42 46 121578 51113 63316285
Injection site warmth 17.17 12.42 4 121620 15191 63352207
Skin reaction 17.17 12.42 65 121559 14784 63352614
Vitamin D deficiency 17.07 12.42 3 121621 13889 63353509
Abdominal distension 16.87 12.42 97 121527 86518 63280880
Nervous system disorder 16.85 12.42 76 121548 18690 63348708
Urinary incontinence 16.78 12.42 22 121602 31992 63335406
Malaise 16.73 12.42 965 120659 414989 62952409
Right ventricular failure 16.71 12.42 6 121618 17182 63350216
Neuroleptic malignant syndrome 16.70 12.42 56 121568 12000 63355398
Back pain 16.68 12.42 382 121242 263763 63103635
Ascites 16.63 12.42 33 121591 40695 63326703
Discomfort 16.59 12.42 429 121195 166945 63200453
Glaucoma 16.56 12.42 76 121548 18829 63348569
Finger deformity 16.54 12.42 42 121582 7703 63359695
Product quality issue 16.50 12.42 27 121597 35838 63331560
Cold urticaria 16.30 12.42 7 121617 129 63367269
Mite allergy 16.27 12.42 12 121612 648 63366750
Fear-related avoidance of activities 16.25 12.42 7 121617 130 63367268
Cardiac failure 16.22 12.42 102 121522 89040 63278358
Road traffic accident 16.21 12.42 123 121501 36509 63330889
Muscle tension dysphonia 16.18 12.42 8 121616 206 63367192
Pharyngeal swelling 16.12 12.42 37 121587 6367 63361031
Priapism 16.10 12.42 7 121617 133 63367265
Epistaxis 16.09 12.42 78 121546 72647 63294751
Therapeutic response unexpected 15.92 12.42 8 121616 18751 63348647
Hepatic steatosis 15.91 12.42 102 121522 28667 63338731
Dysuria 15.89 12.42 25 121599 33713 63333685
Dysmetropsia 15.87 12.42 6 121618 78 63367320
Therapeutic response decreased 15.84 12.42 184 121440 61341 63306057
Tendon operation 15.77 12.42 9 121615 312 63367086
Procedural pain 15.77 12.42 11 121613 21558 63345840
Rheumatic disorder 15.62 12.42 24 121600 3048 63364350
Pain in extremity 15.57 12.42 500 121124 330986 63036412
Abdominal pain 15.52 12.42 699 120925 292757 63074641
Sensory loss 15.48 12.42 49 121575 10189 63357209
Malignant neoplasm progression 15.45 12.42 93 121531 82028 63285370
Bacteraemia 15.33 12.42 7 121617 17341 63350057
Therapeutic product effect incomplete 15.29 12.42 330 121294 124726 63242672
Palatal oedema 15.25 12.42 11 121613 574 63366824
Breath sounds abnormal 15.23 12.42 51 121573 10922 63356476
Intestinal fibrosis 15.21 12.42 7 121617 153 63367245
Intestinal strangulation 15.10 12.42 6 121618 90 63367308
Drug use disorder 15.06 12.42 31 121593 4953 63362445
Emergency care examination abnormal 15.05 12.42 4 121620 14 63367384
Foetal monitoring abnormal 15.04 12.42 8 121616 241 63367157
Throat irritation 14.95 12.42 31 121593 37616 63329782
Intervertebral disc protrusion 14.95 12.42 14 121610 23695 63343703
Acute myocardial infarction 14.95 12.42 24 121600 32100 63335298
Vaginal cellulitis 14.92 12.42 6 121618 93 63367305
Product substitution issue 14.86 12.42 6 121618 15990 63351408
Neurotoxicity 14.79 12.42 7 121617 16983 63350415
Skin disorder 14.74 12.42 21 121603 29486 63337912
Retinitis 14.72 12.42 35 121589 6161 63361237
Blood triglycerides increased 14.70 12.42 3 121621 12485 63354913
Pneumocystis jirovecii pneumonia 14.68 12.42 7 121617 16907 63350491
Precancerous cells present 14.64 12.42 16 121608 1451 63365947
Myocardial fibrosis 14.60 12.42 12 121612 760 63366638
Ileus 14.56 12.42 5 121619 14720 63352678
Obstructive airways disorder 14.55 12.42 11 121613 20688 63346710
Hepatotoxicity 14.55 12.42 121 121503 36920 63330478
Limb operation 14.52 12.42 27 121597 4004 63363394
Heavy menstrual bleeding 14.46 12.42 8 121616 17765 63349633
Foetal arrhythmia 14.46 12.42 7 121617 172 63367226
Rash papular 14.41 12.42 6 121618 15696 63351702
Infrequent bowel movements 14.41 12.42 15 121609 1287 63366111
Gastritis fungal 14.20 12.42 6 121618 106 63367292
Mania 14.19 12.42 54 121570 12313 63355085
Anxiety 14.18 12.42 313 121311 217228 63150170
Pelvic fracture 14.15 12.42 4 121620 13344 63354054
Gallbladder cholesterolosis 14.15 12.42 12 121612 794 63366604
Lung infiltration 14.15 12.42 5 121619 14458 63352940
Red blood cell count decreased 14.10 12.42 36 121588 40609 63326789
Foot fracture 14.07 12.42 15 121609 23899 63343499
Diverticulum 13.87 12.42 3 121621 11988 63355410
Subarachnoid haemorrhage 13.87 12.42 5 121619 14278 63353120
Supraventricular tachycardia 13.85 12.42 5 121619 14266 63353132
Tachypnoea 13.78 12.42 8 121616 17294 63350104
Hypertensive crisis 13.77 12.42 6 121618 15280 63352118
Toxic epidermal necrolysis 13.70 12.42 17 121607 25317 63342081
Status epilepticus 13.69 12.42 6 121618 15227 63352171
Distributive shock 13.66 12.42 15 121609 1368 63366030
Respiratory moniliasis 13.65 12.42 7 121617 195 63367203
Nasal congestion 13.63 12.42 72 121552 65588 63301810
Nervousness 13.62 12.42 24 121600 30955 63336443
Red blood cell nucleated morphology present 13.59 12.42 4 121620 22 63367376
Shock 13.49 12.42 15 121609 23448 63343950
Toxic shock syndrome streptococcal 13.48 12.42 6 121618 121 63367277
Upper limb fracture 13.44 12.42 10 121614 18958 63348440
Consciousness fluctuating 13.39 12.42 12 121612 855 63366543
Caesarean section 13.38 12.42 8 121616 17024 63350374
Ischaemic stroke 13.34 12.42 9 121615 17948 63349450
Myalgia 13.28 12.42 199 121425 146330 63221068
Product administration error 13.23 12.42 14 121610 22383 63345015
Gastrointestinal haemorrhage 13.22 12.42 96 121528 81080 63286318
Generalised tonic-clonic seizure 13.20 12.42 22 121602 28994 63338404
Blood iron decreased 12.92 12.42 6 121618 14715 63352683
Incorrect dose administered 12.87 12.42 65 121559 59903 63307495
Malignant melanoma 12.81 12.42 3 121621 11353 63356045
Hyperbilirubinaemia 12.74 12.42 3 121621 11311 63356087
Hypocalcaemia 12.69 12.42 26 121598 31687 63335711
Adverse drug reaction 12.69 12.42 219 121405 79495 63287903
Pleuritic pain 12.67 12.42 39 121585 7990 63359408
Nausea 12.64 12.42 1439 120185 853032 62514366
Paradoxical psoriasis 12.63 12.42 7 121617 229 63367169
Emotional disorder 12.63 12.42 55 121569 13324 63354074
Arteriosclerosis coronary artery 12.59 12.42 40 121584 8333 63359065
Gastrointestinal stoma output increased 12.59 12.42 8 121616 338 63367060
Immunodeficiency 12.58 12.42 74 121550 20180 63347218
Myopathy 12.54 12.42 3 121621 11188 63356210
Labelled drug-drug interaction medication error 12.49 12.42 5 121619 13394 63354004
Lip swelling 12.48 12.42 102 121522 30961 63336437
Breast cancer 12.46 12.42 49 121575 48334 63319064
Pneumonia aspiration 12.44 12.42 30 121594 34510 63332888
Sleep apnoea syndrome 12.43 12.42 23 121601 29110 63338288

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 2002.14 12.87 1198 30850 97898 34826985
Toxicity to various agents 1750.79 12.87 1448 30600 198914 34725969
Drug hypersensitivity 527.35 12.87 497 31551 80032 34844851
Substance abuse 370.02 12.87 167 31881 7474 34917409
Poisoning 235.14 12.87 144 31904 12082 34912801
Overdose 231.94 12.87 347 31701 90712 34834171
Intentional product misuse 218.30 12.87 238 31810 45373 34879510
Drug dependence 178.50 12.87 160 31888 24057 34900826
Asphyxia 177.88 12.87 98 31950 6737 34918146
Depressed level of consciousness 139.76 12.87 184 31864 42657 34882226
Nightmare 107.83 12.87 96 31952 14295 34910588
Respiratory depression 96.03 12.87 95 31953 16150 34908733
Dysarthria 91.87 12.87 135 31913 34647 34890236
Sedation 77.57 12.87 96 31952 20910 34903973
Pulmonary oedema 75.49 12.87 147 31901 47382 34877501
Completed suicide 63.35 12.87 216 31832 97952 34826931
Product used for unknown indication 62.33 12.87 26 32022 957 34923926
Drug interaction 61.28 12.87 385 31663 225561 34699322
Miosis 58.65 12.87 57 31991 9478 34915405
Nephrolithiasis 58.46 12.87 102 31946 30231 34894652
Intentional overdose 54.07 12.87 122 31926 43552 34881331
Chemical poisoning 52.74 12.87 14 32034 117 34924766
Poisoning deliberate 52.25 12.87 49 31999 7795 34917088
Respiratory arrest 47.29 12.87 89 31959 27954 34896929
Red blood cell sedimentation rate 45.22 12.87 22 32026 1166 34923717
Granuloma skin 43.68 12.87 22 32026 1257 34923626
Product dose omission issue 42.26 12.87 29 32019 119682 34805201
Drug use disorder 41.82 12.87 33 32015 4158 34920725
Needle fatigue 41.82 12.87 19 32029 862 34924021
Relapsing-remitting multiple sclerosis 41.65 12.87 20 32028 1030 34923853
Chronic gastrointestinal bleeding 39.83 12.87 14 32034 320 34924563
Pulmonary congestion 38.61 12.87 55 31993 13710 34911173
Hypertonic bladder 38.51 12.87 23 32025 1841 34923042
Fatigue 37.97 12.87 193 31855 370460 34554423
Blood parathyroid hormone decreased 37.89 12.87 21 32027 1459 34923424
Gait spastic 37.86 12.87 19 32029 1077 34923806
Accidental overdose 37.86 12.87 67 31981 20073 34904810
Lower respiratory tract infection 36.53 12.87 86 31962 31551 34893332
Psychotic behaviour 35.91 12.87 16 32032 693 34924190
Patient uncooperative 35.02 12.87 14 32034 461 34924422
Vestibular disorder 34.78 12.87 18 32030 1089 34923794
Drug ineffective 34.75 12.87 261 31787 456490 34468393
Panniculitis 34.57 12.87 22 32026 1972 34922911
Tooth injury 33.34 12.87 18 32030 1187 34923696
Sepsis 32.31 12.87 65 31983 166496 34758387
Bradykinesia 31.21 12.87 27 32021 3866 34921017
Self-medication 30.73 12.87 23 32025 2680 34922203
Poor feeding infant 30.05 12.87 13 32035 524 34924359
Tenosynovitis 29.39 12.87 28 32020 4542 34920341
Hospitalisation 29.20 12.87 8 32040 56894 34867989
Rheumatoid nodule 28.97 12.87 23 32025 2924 34921959
Prescription form tampering 28.45 12.87 12 32036 454 34924429
Cardio-respiratory arrest 28.36 12.87 113 31935 55160 34869723
Asthenia 27.81 12.87 123 31925 245128 34679755
Perineal pain 27.49 12.87 14 32034 819 34924064
Spinal cord infection 27.16 12.87 9 32039 171 34924712
Alcohol interaction 27.07 12.87 22 32026 2891 34921992
Hyperhidrosis 26.34 12.87 138 31910 75554 34849329
Serotonin syndrome 26.14 12.87 57 31991 19876 34905007
Blood ethanol 25.90 12.87 8 32040 120 34924763
COVID-19 25.77 12.87 20 32028 77530 34847353
Ventricular dysfunction 25.25 12.87 24 32024 3881 34921002
Perineal infection 24.82 12.87 12 32036 627 34924256
Coma scale abnormal 24.72 12.87 24 32024 3984 34920899
Optic nerve operation 24.63 12.87 11 32037 479 34924404
Bradyphrenia 24.60 12.87 26 32022 4772 34920111
Scrotal infection 24.58 12.87 12 32036 641 34924242
Monoparesis 24.55 12.87 19 32029 2327 34922556
Alice in wonderland syndrome 24.49 12.87 5 32043 10 34924873
Ulcer 24.33 12.87 35 32013 8800 34916083
Nervous system neoplasm 24.24 12.87 8 32040 150 34924733
Myocardial necrosis 24.16 12.87 9 32039 244 34924639
Rheumatoid arthritis 23.63 12.87 83 31965 38155 34886728
Thrombocytopenia 23.21 12.87 70 31978 156177 34768706
Accidental poisoning 22.42 12.87 12 32036 778 34924105
Analgesic drug level above therapeutic 22.30 12.87 9 32039 304 34924579
Disease progression 21.96 12.87 41 32007 108036 34816847
Otospondylomegaepiphyseal dysplasia 21.96 12.87 7 32041 117 34924766
Overgrowth bacterial 21.79 12.87 7 32041 120 34924763
Oesophagitis chemical 21.73 12.87 6 32042 59 34924824
Arteriosclerosis coronary artery 21.51 12.87 40 32008 12445 34912438
Duodenal ulcer perforation 21.08 12.87 15 32033 1617 34923266
Infected dermal cyst 21.03 12.87 12 32036 882 34924001
Agitated depression 20.50 12.87 8 32040 247 34924636
Enthesopathy 20.19 12.87 23 32025 4590 34920293
Mood swings 19.88 12.87 30 32018 7871 34917012
Logorrhoea 19.80 12.87 17 32031 2409 34922474
Anaemia 19.79 12.87 129 31919 233206 34691677
Off label use 19.65 12.87 269 31779 419255 34505628
Bradypnoea 19.47 12.87 18 32030 2811 34922072
Aggression 19.45 12.87 79 31969 38885 34885998
Prescription drug used without a prescription 19.45 12.87 16 32032 2138 34922745
Secondary hypogonadism 19.19 12.87 8 32040 294 34924589
Tongue disorder 19.06 12.87 24 32024 5315 34919568
Anal haemorrhage 18.91 12.87 17 32031 2561 34922322
Defaecation urgency 18.85 12.87 17 32031 2572 34922311
Tendon pain 18.60 12.87 18 32030 2977 34921906
Drug diversion 18.56 12.87 11 32037 868 34924015
Anal fissure 18.12 12.87 21 32027 4269 34920614
Thrombosis 18.09 12.87 12 32036 50446 34874437
Calcium deficiency 18 12.87 7 32041 214 34924669
Bronchial haemorrhage 17.99 12.87 10 32038 699 34924184
Morganella infection 17.89 12.87 9 32039 513 34924370
Pancytopenia 17.70 12.87 38 32010 95119 34829764
Leukopenia 17.57 12.87 19 32029 62837 34862046
Pneumonia aspiration 17.13 12.87 80 31968 41823 34883060
Febrile neutropenia 17.12 12.87 66 31982 136783 34788100
Opiates positive 16.98 12.87 9 32039 572 34924311
Dehydration 16.70 12.87 62 31986 129907 34794976
Tendonitis 16.65 12.87 30 32018 9110 34915773
Alanine aminotransferase abnormal 16.62 12.87 21 32027 4667 34920216
Arteriovenous fistula 16.20 12.87 11 32037 1100 34923783
Idiopathic pulmonary fibrosis 16.11 12.87 18 32030 3516 34921367
Gastrointestinal mucosa hyperaemia 16.05 12.87 7 32041 288 34924595
Clumsiness 15.92 12.87 13 32035 1719 34923164
Skin necrosis 15.85 12.87 23 32025 5830 34919053
Patient dissatisfaction with treatment 15.77 12.87 5 32043 82 34924801
Pouchitis 15.52 12.87 9 32039 682 34924201
Rheumatoid lung 15.36 12.87 10 32038 932 34923951
Coordination abnormal 15.10 12.87 26 32022 7618 34917265
Umbilical hernia 15.09 12.87 20 32028 4657 34920226
Postmortem blood drug level 15.08 12.87 6 32042 195 34924688
Stoma complication 14.92 12.87 7 32041 342 34924541
Amphetamines positive 14.53 12.87 6 32042 215 34924668
Drug screen positive 14.51 12.87 18 32030 3925 34920958
Paratracheal lymphadenopathy 14.44 12.87 5 32043 109 34924774
Exposure via inhalation 14.43 12.87 4 32044 40 34924843
Blood pressure diastolic decreased 14.26 12.87 28 32020 9066 34915817
Mobility decreased 14.18 12.87 60 31988 30068 34894815
Drug withdrawal syndrome neonatal 14.10 12.87 17 32031 3602 34921281
Blood alcohol increased 14.07 12.87 9 32039 814 34924069
Death 14.03 12.87 470 31578 397579 34527304
Micturition urgency 13.96 12.87 23 32025 6502 34918381
Intracranial aneurysm 13.94 12.87 12 32036 1706 34923177
Cardiac arrest 13.90 12.87 142 31906 96017 34828866
Unresponsive to stimuli 13.84 12.87 56 31992 27513 34897370
Mental status changes 13.72 12.87 9 32039 38074 34886809
Urinary tract infection 13.70 12.87 36 32012 84045 34840838
Pyrexia 13.66 12.87 219 31829 332794 34592089
Dyspnoea 13.47 12.87 254 31794 376528 34548355
Tendon discomfort 13.46 12.87 6 32042 260 34924623
Withdrawal syndrome 13.45 12.87 33 32015 12422 34912461
Exposure via ingestion 13.34 12.87 13 32035 2168 34922715
Brain oedema 13.24 12.87 35 32013 13786 34911097
Dermal cyst 13.08 12.87 12 32036 1855 34923028
Phlebosclerosis 13.04 12.87 5 32043 147 34924736
Large intestinal obstruction 13.03 12.87 11 32037 1524 34923359
Diabetic eye disease 13.01 12.87 4 32044 59 34924824
Anal fistula 12.88 12.87 20 32028 5379 34919504

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 4273.05 11.70 3734 131303 295182 79314169
Drug abuse 1479.06 11.70 1590 133447 161101 79448250
Toxicity to various agents 1272.85 11.70 2431 132606 419109 79190242
Blood parathyroid hormone decreased 514.53 11.70 282 134755 10254 79599097
Panniculitis 477.56 11.70 284 134753 12087 79597264
Granuloma skin 474.28 11.70 255 134782 8919 79600432
Rheumatoid arthritis 434.12 11.70 1036 134001 207434 79401917
Rheumatoid nodule 432.30 11.70 303 134734 17135 79592216
Drug intolerance 367.26 11.70 1131 133906 262988 79346363
Substance abuse 353.37 11.70 221 134816 10305 79599046
Skin necrosis 344.15 11.70 268 134769 17819 79591532
Contraindicated product administered 306.50 11.70 763 134274 156775 79452576
Ulcer 289.37 11.70 303 134734 29669 79579682
Hypercalcaemia 240.78 11.70 311 134726 38119 79571232
Drug tolerance decreased 226.94 11.70 183 134854 12795 79596556
Basal cell carcinoma 225.66 11.70 297 134740 37078 79572273
Skin ulcer 222.94 11.70 359 134678 53791 79555560
Tenosynovitis 221.83 11.70 195 134842 15359 79593992
Inflammation 219.15 11.70 488 134549 93265 79516086
Therapeutic product effect decreased 213.02 11.70 686 134351 163177 79446174
Contrast media allergy 207.11 11.70 96 134941 2426 79606925
C-reactive protein abnormal 205.07 11.70 325 134712 48042 79561309
Red blood cell sedimentation rate increased 202.13 11.70 314 134723 45628 79563723
Drug eruption 191.50 11.70 299 134738 43636 79565715
Asphyxia 183.50 11.70 155 134882 11565 79597786
Psoriatic arthropathy 181.15 11.70 405 134632 77594 79531757
Product dose omission issue 179.13 11.70 98 134939 247439 79361912
Infusion related reaction 178.72 11.70 818 134219 229419 79379932
Treatment failure 173.28 11.70 658 134379 169828 79439523
Overdose 172.66 11.70 693 134344 183513 79425838
Fibromyalgia 167.63 11.70 350 134687 63990 79545361
Poisoning 165.35 11.70 209 134828 25063 79584288
Rash pruritic 164.18 11.70 370 134667 71259 79538092
Drug dependence 161.98 11.70 266 134771 40503 79568848
Duodenal ulcer perforation 147.28 11.70 338 134699 65873 79543478
Peripheral swelling 144.92 11.70 865 134172 268752 79340599
Synovitis 144.36 11.70 571 134466 150163 79459188
Anaemia 143.61 11.70 340 134697 444675 79164676
Enthesopathy 140.99 11.70 133 134904 11475 79597876
Musculoskeletal stiffness 132.19 11.70 617 134420 174391 79434960
Red blood cell sedimentation rate 131.66 11.70 94 134943 5471 79603880
Respiratory depression 131.64 11.70 196 134841 27434 79581917
COVID-19 128.47 11.70 53 134984 157621 79451730
Pancytopenia 128.28 11.70 60 134977 165685 79443666
Bursitis 127.98 11.70 223 134814 35621 79573730
Joint swelling 127.39 11.70 881 134156 287765 79321586
Acute kidney injury 126.65 11.70 453 134584 518951 79090400
Loss of personal independence in daily activities 126.52 11.70 422 134615 102158 79507193
Rheumatoid factor positive 124.93 11.70 298 134739 59541 79549810
Deep vein thrombosis postoperative 118.91 11.70 117 134920 10635 79598716
Tongue disorder 116.88 11.70 131 134906 13844 79595507
Sepsis 115.78 11.70 173 134864 269255 79340096
Lip dry 114.61 11.70 136 134901 15282 79594069
Arthropathy 113.54 11.70 596 134441 176515 79432836
Hypersensitivity 111.34 11.70 793 134244 261446 79347905
Facet joint syndrome 110.39 11.70 115 134922 11187 79598164
Blood cholesterol increased 109.14 11.70 351 134686 83369 79525982
Liver injury 107.63 11.70 272 134765 56342 79553009
C-reactive protein increased 106.45 11.70 467 134570 128560 79480791
Gastric pH decreased 106.16 11.70 44 134993 842 79608509
Fall 105.56 11.70 446 134591 487183 79122168
Rheumatic fever 105.15 11.70 180 134857 28345 79581006
Dehydration 103.13 11.70 163 134874 248024 79361327
Urinary tract infection 100.72 11.70 195 134842 274317 79335034
Neutropenia 99.92 11.70 211 134826 287499 79321852
Nightmare 96.39 11.70 164 134873 25697 79583654
Lower respiratory tract infection 96.38 11.70 454 134583 128766 79480585
Hand deformity 94.92 11.70 388 134649 103531 79505820
Joint range of motion decreased 94.91 11.70 188 134849 33094 79576257
Intentional product misuse 93.08 11.70 363 134674 94802 79514549
Febrile neutropenia 92.89 11.70 155 134882 230844 79378507
Peripheral venous disease 92.28 11.70 124 134913 15785 79593566
Disease progression 91.85 11.70 106 134931 184256 79425095
Product use issue 91.65 11.70 639 134398 209183 79400168
Tendonitis 91.31 11.70 153 134884 23677 79585674
Helicobacter infection 90.63 11.70 292 134745 69412 79539939
Derealisation 88.49 11.70 47 134990 1602 79607749
Mobility decreased 88.03 11.70 425 134612 121750 79487601
Rash 87.63 11.70 1420 133617 576938 79032413
Autoimmune disorder 86.63 11.70 123 134914 16489 79592862
Miosis 83.96 11.70 118 134919 15671 79593680
Renal failure 77.91 11.70 138 134899 200830 79408521
Depersonalisation/derealisation disorder 75.14 11.70 44 134993 1818 79607533
Swollen joint count increased 74.61 11.70 137 134900 22790 79586561
Prescribed overdose 74.09 11.70 184 134853 37699 79571652
Platelet count decreased 72.49 11.70 137 134900 194527 79414824
Deformity 71.84 11.70 85 134952 9520 79599831
Thrombocytopenia 71.63 11.70 221 134816 265038 79344313
Hepatic enzyme increased 71.03 11.70 541 134496 182069 79427282
Adverse event 70.94 11.70 244 134793 59970 79549381
H1N1 influenza 70.05 11.70 47 134990 2472 79606879
Hypotension 69.73 11.70 448 134589 439869 79169482
Folliculitis 69.29 11.70 229 134808 55151 79554200
Anti-cyclic citrullinated peptide antibody positive 67.84 11.70 300 134737 82843 79526508
Patient uncooperative 67.55 11.70 30 135007 684 79608667
Alanine aminotransferase abnormal 67.20 11.70 79 134958 8788 79600563
Poisoning deliberate 67.02 11.70 117 134920 18711 79590640
Glossodynia 66.34 11.70 348 134689 102989 79506362
Renal impairment 66.10 11.70 103 134934 157680 79451671
Injection site erythema 65.78 11.70 25 135012 78172 79531179
Asthenia 64.61 11.70 555 134482 511134 79098217
Loss of employment 64.21 11.70 45 134992 2542 79606809
Drug tolerance 63.62 11.70 76 134961 8599 79600752
Cerebrovascular accident 63.52 11.70 103 134934 155189 79454162
Musculoskeletal disorder 63.39 11.70 123 134914 21325 79588026
Pericarditis 62.82 11.70 345 134692 103891 79505460
Muscle injury 62.73 11.70 203 134834 48358 79560993
Fear of injection 62.39 11.70 70 134967 7404 79601947
Obliterative bronchiolitis 62.26 11.70 47 134990 2981 79606370
Blister 61.33 11.70 379 134658 119097 79490254
Irritable bowel syndrome 61.32 11.70 238 134799 62003 79547348
Feeling of despair 60.71 11.70 45 134992 2776 79606575
Mental status changes 60.48 11.70 19 135018 66940 79542411
Sciatica 60.43 11.70 157 134880 33065 79576286
Gastric disorder 60.16 11.70 169 134868 37264 79572087
Injection site pain 60.08 11.70 79 134958 129759 79479592
Anti-cyclic citrullinated peptide antibody 59.78 11.70 61 134976 5791 79603560
Cogwheel rigidity 59.26 11.70 46 134991 3042 79606309
Atrial fibrillation 59.18 11.70 157 134880 197729 79411622
Multiple organ dysfunction syndrome 58.94 11.70 70 134967 120176 79489175
Pemphigus 58.28 11.70 327 134710 99255 79510096
Soft tissue disorder 58.16 11.70 48 134989 3467 79605884
Accidental overdose 58.11 11.70 173 134864 39408 79569943
Feeling of body temperature change 57.12 11.70 57 134980 5269 79604082
Wrong technique in product usage process 56.74 11.70 27 135010 73848 79535503
Abdominal discomfort 54.62 11.70 657 134380 250070 79359281
Rheumatoid lung 54.17 11.70 50 134987 4195 79605156
Dyspnoea 53.57 11.70 1077 133960 855948 78753403
Serotonin syndrome 51.77 11.70 181 134856 44846 79564505
Therapy cessation 51.46 11.70 3 135034 37559 79571792
Accidental poisoning 51.15 11.70 33 135004 1624 79607727
Discomfort 51.00 11.70 376 134661 125241 79484110
Dissociation 50.61 11.70 47 134990 3974 79605377
Cardiac failure congestive 50.59 11.70 103 134934 142299 79467052
Hospitalisation 50.45 11.70 51 134986 94185 79515166
Injury 50.44 11.70 262 134775 77234 79532117
Musculoskeletal pain 50.23 11.70 321 134716 102033 79507318
Acute respiratory failure 50.14 11.70 19 135018 59522 79549829
Septic shock 49.70 11.70 82 134955 122719 79486632
Bradypnoea 49.36 11.70 56 134981 5996 79603355
Pulmonary embolism 49.22 11.70 139 134898 171515 79437836
Chronic kidney disease 48.08 11.70 26 135011 66128 79543223
Haemoglobin decreased 48.05 11.70 203 134834 221916 79387435
White blood cell count decreased 47.92 11.70 161 134876 188127 79421224
Urticaria 47.91 11.70 502 134535 184699 79424652
Myocardial infarction 47.17 11.70 157 134880 183972 79425379
Bone marrow failure 47.06 11.70 14 135023 51093 79558258
Arthralgia 47.02 11.70 1284 133753 570519 79038832
Pyrexia 46.95 11.70 838 134199 677871 78931480
Neuropathy peripheral 46.23 11.70 107 134930 141198 79468153
Chemical poisoning 45.87 11.70 16 135021 186 79609165
Product used for unknown indication 45.82 11.70 30 135007 1514 79607837
Muscle disorder 45.18 11.70 52 134985 5655 79603696
Mood swings 44.75 11.70 102 134935 19778 79589573
Pulmonary hypertension 44.58 11.70 13 135024 48067 79561284
Haematuria 44.53 11.70 31 135006 68805 79540546
Menstrual disorder 44.49 11.70 44 134993 4023 79605328
Pleural effusion 44.37 11.70 114 134923 145148 79464203
Sopor 44.13 11.70 3 135034 33007 79576344
Leukopenia 43.35 11.70 82 134955 116431 79492920
Injection site swelling 43.24 11.70 13 135024 47119 79562232
Haematochezia 42.97 11.70 51 134986 87594 79521757
Herpes zoster 42.68 11.70 287 134750 92796 79516555
Lactic acidosis 42.54 11.70 34 135003 70325 79539026
Depressed level of consciousness 42.53 11.70 295 134742 96357 79512994
Hypokalaemia 42.51 11.70 115 134922 143925 79465426
Visceral congestion 42.33 11.70 24 135013 932 79608419
C-reactive protein 42.19 11.70 47 134990 4932 79604419
Food allergy 42.14 11.70 70 134967 10754 79598597
Agranulocytosis 42.08 11.70 12 135025 45018 79564333
Type 2 diabetes mellitus 42.05 11.70 200 134837 56922 79552429
Unevaluable event 41.64 11.70 21 135016 55564 79553787
Pulmonary fibrosis 41.29 11.70 166 134871 43946 79565405
Adjustment disorder with depressed mood 41.20 11.70 63 134974 9023 79600328
Transient ischaemic attack 40.86 11.70 19 135018 52676 79556675
Therapy non-responder 40.77 11.70 282 134755 92023 79517328
Obesity 40.21 11.70 141 134896 34984 79574367
Allergy to chemicals 39.88 11.70 34 135003 2568 79606783
Hip arthroplasty 39.61 11.70 142 134895 35614 79573737
Toxicologic test abnormal 39.33 11.70 26 135011 1334 79608017
Arthritis 39.00 11.70 330 134707 114550 79494801
Dry mouth 38.93 11.70 269 134768 87750 79521601
Hallucinations, mixed 38.84 11.70 53 134984 6846 79602505
Hypervolaemia 38.75 11.70 12 135025 42678 79566673
Swollen tongue 38.10 11.70 158 134879 42412 79566939
Neurotoxicity 38.08 11.70 5 135032 32513 79576838
Mydriasis 38.04 11.70 89 134948 17554 79591797
Pancreatic fibrosis 37.96 11.70 12 135025 100 79609251
Hypercholesterolaemia 37.83 11.70 105 134932 22990 79586361
Therapeutic product ineffective 37.69 11.70 29 135008 1893 79607458
Haemorrhage 37.66 11.70 60 134977 91058 79518293
Full blood count abnormal 37.43 11.70 11 135026 40463 79568888
Feeling jittery 37.16 11.70 73 134964 12768 79596583
Hyperkalaemia 37.12 11.70 87 134950 114311 79495040
Hyperhidrosis 37.01 11.70 406 134631 151086 79458265
Haematocrit decreased 36.60 11.70 30 135007 61282 79548069
Drug use disorder 36.47 11.70 58 134979 8593 79600758
Neutropenic sepsis 35.73 11.70 114 134923 26950 79582401
Disease recurrence 35.63 11.70 15 135022 44094 79565257
Sleep disorder 35.07 11.70 257 134780 85420 79523931
Fatigue 34.99 11.70 1256 133781 928471 78680880
Wound 34.94 11.70 325 134712 115854 79493497
Diabetes mellitus 34.94 11.70 49 134988 78341 79531010
Device issue 34.73 11.70 3 135034 27105 79582246
Acute myocardial infarction 34.49 11.70 48 134989 76988 79532363
Thrombosis 34.17 11.70 56 134981 84044 79525307
Granuloma 34.12 11.70 55 134982 8242 79601109
Swelling face 34.11 11.70 222 134815 70990 79538361
Drooling 34.03 11.70 46 134991 5888 79603463
Therapy interrupted 34.00 11.70 6 135031 31335 79578016
Hypoxia 33.91 11.70 78 134959 103165 79506186
Osteoarthritis 33.54 11.70 258 134779 87051 79522300
Systemic lupus erythematosus 33.52 11.70 333 134704 120816 79488535
Injection site pruritus 33.17 11.70 15 135022 42268 79567083
Night sweats 33.12 11.70 175 134862 51920 79557431
Lymphopenia 32.83 11.70 6 135031 30551 79578800
Device expulsion 32.76 11.70 3 135034 25858 79583493
Lupus vulgaris 32.59 11.70 34 135003 3312 79606039
Fungal infection 32.45 11.70 15 135022 41733 79567618
Paralysis 32.35 11.70 70 134967 13107 79596244
Cardiomyopathy 32.35 11.70 5 135032 28769 79580582
Parosmia 32.33 11.70 49 134988 6965 79602386
Respiratory failure 32.31 11.70 177 134860 180734 79428617
Wrist surgery 32.16 11.70 19 135018 798 79608553
Necrosis ischaemic 31.91 11.70 21 135016 1069 79608282
Staphylococcal infection 31.83 11.70 31 135006 58264 79551087
X-ray abnormal 31.73 11.70 44 134993 5769 79603582
Contusion 31.13 11.70 387 134650 148389 79460962
Road traffic accident 30.78 11.70 151 134886 43513 79565838
Gastrointestinal haemorrhage 30.71 11.70 137 134900 147582 79461769
Pneumonia 30.55 11.70 868 134169 659378 78949973
Needle fatigue 30.43 11.70 19 135018 883 79608468
No adverse event 29.48 11.70 13 135024 37179 79572172
Treatment noncompliance 29.47 11.70 27 135010 52241 79557110
Post-traumatic neck syndrome 29.35 11.70 26 135011 2068 79607283
Chronic obstructive pulmonary disease 29.31 11.70 63 134974 85356 79523995
Alanine aminotransferase increased 29.07 11.70 411 134626 162159 79447192
Prostate cancer 29.06 11.70 10 135027 33258 79576093
Deep vein thrombosis 29.01 11.70 106 134931 120813 79488538
Haematoma 28.21 11.70 28 135009 52167 79557184
Off label use 28.19 11.70 1253 133784 905962 78703389
Lower limb fracture 28.15 11.70 95 134942 23120 79586231
Renal papillary necrosis 28.12 11.70 14 135023 416 79608935
Blood glucose increased 28.10 11.70 100 134937 114875 79494476
Accidental exposure to product 28.08 11.70 9 135028 31313 79578038
Epistaxis 27.92 11.70 96 134941 111419 79497932
Blood pressure systolic increased 27.45 11.70 201 134836 66785 79542566
Sinus disorder 27.42 11.70 3 135034 22461 79586890
Ascites 27.39 11.70 54 134983 75508 79533843
Premature labour 27.13 11.70 50 134987 8340 79601011
Alopecia 27.10 11.70 546 134491 230809 79378542
Swelling 26.92 11.70 516 134521 216195 79393156
Chills 26.87 11.70 160 134877 160074 79449277
Soft tissue injury 26.74 11.70 23 135014 1758 79607593
Liver function test abnormal 26.73 11.70 194 134843 64281 79545070
Lung disorder 26.60 11.70 230 134807 80327 79529024
Transaminases increased 26.57 11.70 29 135008 51714 79557637
Weight decreased 26.28 11.70 433 134604 354765 79254586
Dysphagia 26.16 11.70 112 134925 122024 79487327
Drug resistance 26.02 11.70 20 135017 42193 79567158
Tenosynovitis stenosans 25.99 11.70 29 135008 3049 79606302
Mitral valve incompetence 25.98 11.70 8 135029 28557 79580794
White blood cell count increased 25.64 11.70 55 134982 74578 79534773
Device related infection 25.62 11.70 13 135024 34281 79575070
Gait spastic 25.55 11.70 19 135018 1178 79608173
Blood calcium decreased 25.41 11.70 11 135026 31808 79577543
Full blood count decreased 25.33 11.70 7 135030 26812 79582539
Dyspnoea exertional 25.32 11.70 70 134967 87003 79522348
Tumour lysis syndrome 25.08 11.70 5 135032 23934 79585417
Myelodysplastic syndrome 24.96 11.70 10 135027 30291 79579060
Cytokine release syndrome 24.93 11.70 15 135022 35983 79573368
Synovial fluid analysis 24.84 11.70 25 135012 2334 79607017
Lymphocyte count decreased 24.84 11.70 26 135011 47263 79562088
Liver disorder 24.56 11.70 208 134829 72209 79537142
Myopathy 24.47 11.70 3 135034 20560 79588791
Prescribed underdose 24.44 11.70 107 134930 29407 79579944
Arteriosclerosis coronary artery 24.39 11.70 76 134961 17740 79591611
Skin lesion 24.33 11.70 21 135016 41823 79567528
Tooth injury 24.18 11.70 23 135014 2005 79607346
Emotional disorder 24.15 11.70 66 134971 14321 79595030
Otospondylomegaepiphyseal dysplasia 24.13 11.70 7 135030 42 79609309
Device dislocation 24.12 11.70 7 135030 25963 79583388
Fear of eating 24.03 11.70 13 135024 460 79608891
Head injury 23.94 11.70 17 135020 37352 79571999
Scleritis 23.82 11.70 33 135004 4323 79605028
Chronic gastrointestinal bleeding 23.78 11.70 13 135024 470 79608881
Relapsing-remitting multiple sclerosis 23.59 11.70 20 135017 1499 79607852
Anaphylactic reaction 23.55 11.70 231 134806 83512 79525839
Coronary artery disease 23.55 11.70 47 134990 65427 79543924
Diabetes mellitus inadequate control 23.55 11.70 6 135031 24258 79585093
Laboratory test abnormal 23.53 11.70 9 135028 28039 79581312
Sternal fracture 23.38 11.70 25 135012 2505 79606846
Blood immunoglobulin M increased 23.33 11.70 19 135018 1347 79608004
Pneumocystis jirovecii pneumonia 23.29 11.70 13 135024 32495 79576856
Blood urea increased 23.27 11.70 29 135008 48761 79560590
Tricuspid valve incompetence 23.16 11.70 3 135034 19709 79589642
Delirium 23.10 11.70 232 134805 84395 79524956
Labelled drug-drug interaction medication error 22.99 11.70 9 135028 27641 79581710
Temperature regulation disorder 22.98 11.70 38 134999 5815 79603536
Pneumonia viral 22.89 11.70 49 134988 9109 79600242
Encephalopathy 22.88 11.70 50 134987 67347 79542004
Shock 22.81 11.70 24 135013 43524 79565827
Diaphragmatic rupture 22.80 11.70 10 135027 221 79609130
Posterior reversible encephalopathy syndrome 22.78 11.70 8 135029 26273 79583078
Acute myeloid leukaemia 22.64 11.70 12 135025 30873 79578478
Libido increased 22.55 11.70 22 135015 1979 79607372
Body temperature decreased 22.54 11.70 111 134926 32034 79577317
Appendicitis 22.52 11.70 4 135033 20790 79588561
Cough 22.48 11.70 462 134575 366327 79243024
Hypoglycaemia 22.48 11.70 92 134945 101502 79507849
Bradycardia 22.39 11.70 136 134901 135421 79473930
Renal disorder 22.29 11.70 23 135014 42082 79567269
Aspartate aminotransferase increased 22.23 11.70 344 134693 138297 79471054
Obstructive airways disorder 21.94 11.70 13 135024 31446 79577905
Proteinuria 21.88 11.70 14 135023 32488 79576863
Dislocation of vertebra 21.85 11.70 44 134993 7836 79601515
Eosinophilia 21.58 11.70 27 135010 45318 79564033
Gait inability 21.47 11.70 172 134865 58745 79550606
Metastases to eye 21.42 11.70 10 135027 257 79609094
Hypertension 21.41 11.70 722 134315 330270 79279081
Ischaemic stroke 21.32 11.70 15 135022 33116 79576235
Schizophrenia 21.27 11.70 66 134971 15374 79593977
Plasma cell myeloma 21.14 11.70 36 135001 53223 79556128
Precancerous cells present 21.06 11.70 17 135020 1190 79608161
Product prescribing error 20.99 11.70 27 135010 44786 79564565
Sleep disorder due to general medical condition, insomnia type 20.99 11.70 136 134901 43420 79565931
Cerebral infarction 20.91 11.70 28 135009 45648 79563703
Melaena 20.81 11.70 45 134992 60845 79548506
Blood potassium decreased 20.80 11.70 29 135008 46483 79562868
Abnormal weight gain 20.78 11.70 24 135013 2620 79606731
Flushing 20.76 11.70 78 134959 88190 79521161
Duodenal ulcer repair 20.75 11.70 7 135030 73 79609278
Glaucoma 20.64 11.70 77 134960 19684 79589667
Pseudomonas infection 20.61 11.70 5 135032 20898 79588453
Pericardial effusion 20.50 11.70 29 135008 46208 79563143
Cognitive disorder 20.49 11.70 56 134981 69870 79539481
Respiratory arrest 20.42 11.70 167 134870 57383 79551968
Drug withdrawal syndrome 20.30 11.70 114 134923 34604 79574747
Hypertonic bladder 20.29 11.70 30 135007 4171 79605180
Blood immunoglobulin A decreased 20.28 11.70 18 135019 1435 79607916
Gastrointestinal stoma output increased 20.06 11.70 11 135026 400 79608951
Tachypnoea 20.01 11.70 15 135022 32048 79577303
Hernia 19.97 11.70 69 134968 16990 79592361
Restless legs syndrome 19.92 11.70 77 134960 20015 79589336
Hostility 19.91 11.70 22 135015 2288 79607063
Psychotic behaviour 19.91 11.70 16 135021 1113 79608238
Beta haemolytic streptococcal infection 19.88 11.70 21 135016 2076 79607275
Electrolyte imbalance 19.85 11.70 14 135023 30867 79578484
Alveolar rhabdomyosarcoma 19.77 11.70 5 135032 16 79609335
Lymphoma 19.71 11.70 3 135034 17457 79591894
Bacteraemia 19.66 11.70 16 135021 32808 79576543
Surgery 19.59 11.70 16 135021 32750 79576601
Device malfunction 19.52 11.70 6 135031 21442 79587909
Status epilepticus 19.46 11.70 9 135028 25032 79584319
Hyperglycaemia 19.38 11.70 58 134979 70277 79539074
Supraventricular tachycardia 19.27 11.70 6 135031 21264 79588087
International normalised ratio increased 19.19 11.70 76 134961 84645 79524706
Acute respiratory distress syndrome 19.18 11.70 28 135009 44039 79565312
Blood creatinine increased 19.14 11.70 169 134868 154888 79454463
Tubulointerstitial nephritis 19.01 11.70 22 135015 38213 79571138
Incontinence 19.01 11.70 60 134977 14104 79595247
Blood triglycerides increased 18.94 11.70 6 135031 21034 79588317
Premature delivery 18.92 11.70 8 135029 23459 79585892
Acarodermatitis 18.88 11.70 17 135020 1381 79607970
Grip strength decreased 18.66 11.70 80 134957 21789 79587562
Fear-related avoidance of activities 18.63 11.70 7 135030 102 79609249
Hypertensive crisis 18.56 11.70 6 135031 20764 79588587
Wheezing 18.52 11.70 289 134748 116375 79492976
Scrotal infection 18.41 11.70 12 135025 601 79608750
Bone pain 18.39 11.70 42 134995 55700 79553651
Optic nerve operation 18.26 11.70 11 135026 479 79608872
Blood ethanol 18.23 11.70 8 135029 177 79609174
Hypoaesthesia oral 18.20 11.70 59 134978 14065 79595286
Cold urticaria 18.15 11.70 7 135030 110 79609241
Cardiac failure 18.14 11.70 171 134866 154671 79454680
Adverse drug reaction 18.12 11.70 182 134855 66210 79543141
Visual acuity reduced 18.11 11.70 14 135023 29455 79579896
Oxygen saturation decreased 18.05 11.70 136 134901 128911 79480440
Blood pressure decreased 17.93 11.70 97 134940 99369 79509982
Foetal arrhythmia 17.92 11.70 6 135031 61 79609290
Excessive eye blinking 17.87 11.70 18 135019 1683 79607668
Neutrophil count decreased 17.85 11.70 90 134947 93869 79515482
Gallbladder cholesterolosis 17.84 11.70 12 135025 634 79608717
Clostridium difficile colitis 17.82 11.70 17 135020 32266 79577085
Drug reaction with eosinophilia and systemic symptoms 17.69 11.70 53 134984 64191 79545160
Therapeutic response decreased 17.64 11.70 182 134855 66671 79542680
Gastroenteritis 17.61 11.70 19 135018 34063 79575288
Leukocytosis 17.59 11.70 29 135008 43426 79565925
Lip swelling 17.48 11.70 124 134913 40787 79568564
Pharyngitis 17.45 11.70 8 135029 22367 79586984
Right ventricular failure 17.42 11.70 9 135028 23488 79585863
Disseminated intravascular coagulation 17.41 11.70 21 135016 35821 79573530
Overgrowth bacterial 17.41 11.70 8 135029 198 79609153
Dry skin 17.38 11.70 58 134979 67937 79541414
Rheumatic disorder 17.38 11.70 24 135013 3134 79606217
Osteonecrosis of jaw 17.36 11.70 29 135008 43197 79566154
Toxic skin eruption 17.34 11.70 8 135029 22285 79587066
Hepatocellular injury 17.26 11.70 34 135003 47559 79561792
Opiates positive 17.22 11.70 14 135023 990 79608361
Hip fracture 17.21 11.70 16 135021 30745 79578606
Needle issue 17.21 11.70 55 134982 13013 79596338
Dysuria 17.13 11.70 38 134999 50913 79558438
Impaired healing 17.05 11.70 225 134812 87430 79521921
Cerebral haemorrhage 17.04 11.70 46 134991 57627 79551724
Enterococcal infection 16.98 11.70 3 135034 15657 79593694
Subdural haematoma 16.83 11.70 17 135020 31417 79577934
Polyneuropathy 16.82 11.70 10 135027 24141 79585210
Blood loss anaemia 16.74 11.70 3 135034 15495 79593856
Pharyngeal swelling 16.71 11.70 39 134998 7680 79601671
Ileus 16.69 11.70 12 135025 26199 79583152
Haemorrhage intracranial 16.67 11.70 12 135025 26181 79583170
Lung infiltration 16.65 11.70 9 135028 22903 79586448
Derailment 16.59 11.70 6 135031 78 79609273
Oesophagitis chemical 16.59 11.70 6 135031 78 79609273
Underdose 16.56 11.70 19 135018 33132 79576219
Coagulopathy 16.55 11.70 22 135015 35984 79573367
Electrocardiogram abnormal 16.51 11.70 4 135033 16733 79592618
Atrial flutter 16.45 11.70 8 135029 21617 79587734
Post procedural complication 16.40 11.70 10 135027 23819 79585532
Perineal pain 16.30 11.70 14 135023 1068 79608283
Respiratory distress 16.15 11.70 48 134989 58291 79551060
Intervertebral disc protrusion 16.14 11.70 10 135027 23611 79585740
Somnolence 16.13 11.70 524 134513 238457 79370894
Injection site bruising 16.01 11.70 28 135009 40974 79568377
Blood lactate dehydrogenase increased 15.99 11.70 26 135011 39144 79570207
Chest discomfort 15.93 11.70 153 134884 137891 79471460
Myocardial fibrosis 15.92 11.70 17 135020 1701 79607650
Emotional distress 15.88 11.70 27 135010 39942 79569409
Anhedonia 15.84 11.70 3 135034 14895 79594456
Mycotic allergy 15.82 11.70 16 135021 1503 79607848
Product storage error 15.77 11.70 4 135033 16222 79593129
Dysmetropsia 15.75 11.70 6 135031 91 79609260
Analgesic drug level above therapeutic 15.74 11.70 10 135027 479 79608872
Rectal haemorrhage 15.71 11.70 71 134966 76229 79533122
Injection site warmth 15.71 11.70 3 135034 14804 79594547
Foetal death 15.65 11.70 39 134998 8005 79601346
Vaginal cellulitis 15.63 11.70 6 135031 93 79609258
Staphylococcal sepsis 15.59 11.70 3 135034 14723 79594628
Live birth 15.56 11.70 68 134969 18676 79590675
Emergency care examination abnormal 15.54 11.70 4 135033 14 79609337
Pleuritic pain 15.50 11.70 45 134992 10107 79599244
Alice in wonderland syndrome 15.48 11.70 5 135032 45 79609306
Perineal infection 15.44 11.70 12 135025 795 79608556
Multiple sclerosis relapse 15.40 11.70 35 135002 46498 79562853
Postmortem blood drug level abnormal 15.36 11.70 11 135026 643 79608708
Pneumonia streptococcal 15.32 11.70 21 135016 2724 79606627
Nasal congestion 15.31 11.70 72 134965 76480 79532871
Bladder cancer 15.20 11.70 7 135030 19519 79589832
Eosinophil count increased 15.18 11.70 5 135032 17100 79592251
Cardiogenic shock 15.15 11.70 30 135007 41884 79567467
Abdominal pain 15.02 11.70 805 134232 388764 79220587
Spinal compression fracture 14.98 11.70 5 135032 16953 79592398
Muscle rigidity 14.91 11.70 70 134967 19812 79589539
Crepitations 14.91 11.70 44 134993 9973 79599378
Respiratory moniliasis 14.89 11.70 8 135029 279 79609072
Cardiac disorder 14.89 11.70 59 134978 65698 79543653
Nephropathy toxic 14.87 11.70 8 135029 20411 79588940
Bronchitis chronic 14.86 11.70 27 135010 4455 79604896
Incubator therapy 14.83 11.70 5 135032 52 79609299
Incorrect dose administered 14.78 11.70 73 134964 76557 79532794
Infusion site pain 14.77 11.70 3 135034 14173 79595178
Foetal monitoring abnormal 14.74 11.70 7 135030 187 79609164
Hypoaesthesia 14.74 11.70 403 134634 178949 79430402
Confusional state 14.74 11.70 669 134368 317328 79292023
Spinal cord infection 14.74 11.70 10 135027 536 79608815
Malaise 14.70 11.70 990 134047 488879 79120472
Blood bilirubin increased 14.63 11.70 60 134977 66172 79543179
Influenza like illness 14.60 11.70 67 134970 71640 79537711
Squamous cell carcinoma of skin 14.56 11.70 3 135034 14030 79595321
Knee arthroplasty 14.54 11.70 124 134913 43124 79566227
Laryngeal dyspnoea 14.54 11.70 8 135029 293 79609058
Upper respiratory tract infection 14.53 11.70 226 134811 90942 79518409
Administration site bruise 14.51 11.70 7 135030 194 79609157
Pemphigoid 14.46 11.70 4 135033 15311 79594040
Cardiac failure acute 14.41 11.70 7 135030 18922 79590429
Skin disorder 14.36 11.70 22 135015 33921 79575430
Agitated depression 14.34 11.70 9 135028 422 79608929
Burning sensation 14.32 11.70 51 134986 58581 79550770
Knee deformity 14.24 11.70 14 135023 1271 79608080
Hepatic encephalopathy 14.20 11.70 12 135025 24154 79585197
Hyponatraemia 14.07 11.70 214 134823 177634 79431717
Graft versus host disease 14.05 11.70 4 135033 15022 79594329
Vestibular disorder 14.03 11.70 19 135018 2436 79606915
Cholesteatoma 14.01 11.70 6 135031 125 79609226
Abscess 13.98 11.70 11 135026 22940 79586411
Hot flush 13.90 11.70 47 134990 54830 79554521
Diverticulum 13.86 11.70 4 135033 14892 79594459
Fracture 13.86 11.70 10 135027 21791 79587560
Dialysis 13.79 11.70 7 135030 18455 79590896
Red blood cell nucleated morphology present 13.79 11.70 4 135033 24 79609327
Generalised tonic-clonic seizure 13.76 11.70 34 135003 43876 79565475
Anaphylactic shock 13.68 11.70 25 135012 35971 79573380
Malnutrition 13.44 11.70 11 135026 22491 79586860
Blindness 13.40 11.70 17 135020 28366 79580985
Large intestine perforation 13.39 11.70 4 135033 14563 79594788
Bronchitis 13.36 11.70 149 134888 130495 79478856
Dysarthria 13.32 11.70 174 134863 67448 79541903
Spinal fracture 13.26 11.70 7 135030 18047 79591304
Cataract operation 13.25 11.70 28 135009 5157 79604194
Abdominal distension 13.23 11.70 134 134903 119516 79489835
Death 13.23 11.70 805 134232 565709 79043642
Ill-defined disorder 13.19 11.70 170 134867 65705 79543646
Product administration error 13.13 11.70 21 135016 31825 79577526
Myocardial necrosis 13.10 11.70 9 135028 492 79608859
Aggression 13.10 11.70 138 134899 50820 79558531
Pathogen resistance 13.07 11.70 4 135033 14338 79595013
Sensory loss 13.05 11.70 50 134987 12941 79596410
Secondary hypogonadism 13.02 11.70 8 135029 361 79608990
Shock haemorrhagic 13.02 11.70 9 135028 20051 79589300
Skin laceration 13.01 11.70 18 135019 28944 79580407
Jaundice neonatal 12.97 11.70 6 135031 151 79609200
Paradoxical psoriasis 12.96 11.70 7 135030 247 79609104
Skin discolouration 12.94 11.70 116 134921 40918 79568433
Atrioventricular block complete 12.86 11.70 6 135031 16604 79592747
Logorrhoea 12.86 11.70 25 135012 4340 79605011
Oedema peripheral 12.84 11.70 327 134710 251961 79357390
Infective pulmonary exacerbation of cystic fibrosis 12.82 11.70 3 135034 12848 79596503
Lung neoplasm malignant 12.76 11.70 17 135020 27775 79581576
Coronary artery occlusion 12.71 11.70 5 135032 15310 79594041
Atrioventricular block 12.65 11.70 4 135033 14037 79595314
Infected dermal cyst 12.64 11.70 13 135024 1245 79608106
Splenomegaly 12.58 11.70 10 135027 20744 79588607
Ventricular extrasystoles 12.58 11.70 9 135028 19695 79589656
Hypocalcaemia 12.48 11.70 43 134994 49881 79559470
Abdominal pain upper 12.44 11.70 480 134557 223339 79386012
Soft tissue swelling 12.43 11.70 14 135023 1487 79607864
Immunodeficiency 12.41 11.70 71 134966 21697 79587654
Muscle tension dysphonia 12.38 11.70 6 135031 168 79609183
Osteonecrosis 12.36 11.70 21 135016 31074 79578277
Skin cancer 12.33 11.70 5 135032 15035 79594316
Lower gastrointestinal haemorrhage 12.22 11.70 6 135031 16119 79593232
Nail bed tenderness 12.18 11.70 8 135029 406 79608945
Anal haemorrhage 12.17 11.70 24 135013 4210 79605141
Product name confusion 12.15 11.70 6 135031 175 79609176
Red blood cell count decreased 12.15 11.70 53 134984 57460 79551891
Tendon operation 12.14 11.70 7 135030 281 79609070
Cholelithiasis 12.08 11.70 47 134990 52617 79556734
Haemodialysis 11.99 11.70 8 135029 18160 79591191
COVID-19 pneumonia 11.91 11.70 19 135018 28830 79580521
Aspergillus infection 11.91 11.70 9 135028 19152 79590199
End stage renal disease 11.90 11.70 3 135034 12217 79597134
Oropharyngeal pain 11.87 11.70 123 134914 109230 79500121
Arteriovenous fistula 11.85 11.70 13 135024 1341 79608010
Pulmonary thrombosis 11.83 11.70 3 135034 12168 79597183
Procedural pain 11.78 11.70 13 135024 23071 79586280
Palmar-plantar erythrodysaesthesia syndrome 11.73 11.70 24 135013 33110 79576241
Procedural anxiety 11.72 11.70 10 135027 756 79608595

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
52-28-8 SECONDARY_CAS_RN
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
CHEMBL1201099 ChEMBL_ID
CHEMBL369475 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
1268991009 SNOMEDCT_US
1476002 SNOMEDCT_US
261000 SNOMEDCT_US
387494007 SNOMEDCT_US
85990009 SNOMEDCT_US
CHEMBL1201463 ChEMBL_ID
6059-47-8 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 0054-0243 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 0054-0244 TABLET 30 mg ORAL NDA 32 sections
Codeine sulfate HUMAN PRESCRIPTION DRUG LABEL 1 0054-0245 TABLET 60 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 0054-0650 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
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
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 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
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