colchicine 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |

Stem definitionDrug idCAS RN
726 64-86-8

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • colchicine
  • colchisol
  • colcin
A major alkaloid from Colchicum autumnale L. and found also in other Colchicum species. Its primary therapeutic use is in the treatment of gout, but it has been used also in the therapy of familial Mediterranean fever (PERIODIC DISEASE). Potential to limit COVID-19-related myocardial damage has been hypothesized based on the drug’s mechanisms of action and promising results of ongoing research on colchicine in various cardiac conditions. However, the drug's safety and efficacy for treatment of COVID-19 is not yet established.
  • Molecular weight: 399.44
  • Formula: C22H25NO6
  • CLOGP: 1.29
  • LIPINSKI: 0
  • HAC: 7
  • HDO: 1
  • TPSA: 83.09
  • ALOGS: -4.16
  • ROTB: 5
  • Status: OFP
    • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
1 mg O
1 mg P

ADMET properties:

PropertyValueReference
MRTD (Maximum Recommended Therapeutic Daily Dose) 0.29 µM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BDDCS (Biopharmaceutical Drug Disposition Classification System) 3 Hosey CM, Chan R, Benet LZ
S (Water solubility) 10 mg/mL Bocci G, Oprea TI, Benet LZ
BA (Bioavailability) 50 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution) 6.10 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 2.10 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.61 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 58 hours Lombardo F, Berellini G, Obach RS

Predicted pharmacokinetic/toxicological properties (PK-AZ):

PropertyDescriptionValueUnitConfidenceSimilarity
azlogd74 LogD at pH 7.4 0.970 High 0.82
caco2-efflux Caco-2 efflux ratio (BA/AB) 2.805 High 0.82
caco2-intrinsic-papp Caco-2 intrinsic apparent permeability 26.062 10^-6 cm/s High 0.82
dh-clint Dog hepatocyte intrinsic clearance 1.879 uL/min/10^6 cells High 0.82
dppb Dog plasma protein binding (% unbound) 59.660 % High 0.82
fcs-ppb Fetal calf serum protein binding (% unbound) 73.090 % High 0.82
herg hERG pIC50 4.099 pIC50 High 0.82
hh-clint Human hepatocyte intrinsic clearance 1.288 uL/min/10^6 cells High 0.82
hlm-clint Human liver microsomal intrinsic clearance 3.214 uL/min/mg protein High 0.82
hppb Human plasma protein binding (% unbound) 58.270 % High 0.82
kinase-safety-class ACVR2B,AXL,BRAF,BTK,CAMK2B,CAMK2D,CDK5,CDK9,DDR1,EIF2AK3,EPHB4,ERBB2,GRK2,ITK,JAK2,MAPK10,MAPK7,MAPKAPK2,NTRK2,PDK2,PDK4,PIK3CB,PRKDC,SIK2,TEK 25
kinase-selectivity-class ACVR2B,AXL,EPHB4,ERBB2,GRK2,PDK4,PRKDC 7
mdck-mdr1-efflux MDCK-MDR1 efflux ratio 4.808 High 0.82
mh-clint Mouse hepatocyte intrinsic clearance 6.839 High 0.82
mppb Mouse plasma protein binding (% unbound) 55.840 High 0.82
nih-mdck-mdr1-efflux NIH MDCK-MDR1 efflux ratio 18.621 High 0.82
pfas-class PFAS structural alert (1 = True, 0 = False) 0
pld-class Phospholipidosis risk class (1 = positive, 0 = negative) 0 High 1
pppb Pig plasma protein binding (% unbound) 74.340 % High 0.82
rh-clint Rat hepatocyte intrinsic clearance 1.945 uL/min/10^6 cells High 0.82
rh-fuinc Rat hepatocyte fraction unbound in incubation 91.610 % High 0.82
rppb Rat plasma protein binding (% unbound) 57.880 % High 0.82
solubility-dd Solubility at pH 7.4 in DMSO 952.796 uM High 0.82

Approvals:

DateAgencyCompanyOrphan
July 27, 1961 FDA MERCK

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
Gout 386.46 12.07 178 41852 16681 90569736
Enthesopathy 249.54 12.07 110 41920 9294 90577123
Toxicity to various agents 229.09 12.07 448 41582 287398 90299019
Panniculitis 227.26 12.07 118 41912 14340 90572077
Tenosynovitis 217.87 12.07 115 41915 14452 90571965
Tongue disorder 206.99 12.07 101 41929 10759 90575658
Red blood cell sedimentation rate 196.83 12.07 76 41954 4582 90581835
Blood parathyroid hormone decreased 192.85 12.07 100 41930 12116 90574301
Tendonitis 176.94 12.07 115 41915 21257 90565160
Skin necrosis 170.02 12.07 103 41927 16838 90569579
Acute kidney injury 167.99 12.07 422 41608 319965 90266452
Loss of employment 167.53 12.07 60 41970 2927 90583490
Granuloma skin 167.37 12.07 87 41943 10593 90575824
Rheumatoid nodule 153.57 12.07 103 41927 20063 90566354
Drug ineffective for unapproved indication 134.18 12.07 160 41870 66484 90519933
Diarrhoea 132.30 12.07 814 41216 938376 89648041
Glossodynia 131.00 12.07 4 42026 321775 90264642
Hypercalcaemia 128.69 12.07 115 41915 34125 90552292
Ulcer 128.69 12.07 113 41917 32769 90553648
Drug reaction with eosinophilia and systemic symptoms 125.10 12.07 125 41905 42633 90543784
Drug eruption 117.65 12.07 111 41919 35296 90551121
Basal cell carcinoma 115.41 12.07 107 41923 33282 90553135
Skin ulcer 110.43 12.07 126 41904 49949 90536468
Myopathy 107.64 12.07 71 41959 13447 90572970
Hand deformity 106.89 12.07 8 42022 296354 90290063
Alanine aminotransferase abnormal 105.00 12.07 51 41979 5375 90581042
Drug interaction 104.11 12.07 323 41707 276130 90310287
Multiple organ dysfunction syndrome 96.85 12.07 138 41892 68198 90518219
Fear of injection 88.61 12.07 53 41977 8462 90577955
Aspartate aminotransferase increased 87.54 12.07 165 41865 102772 90483645
Rhabdomyolysis 85.47 12.07 112 41918 51144 90535273
Drug resistance 85.37 12.07 87 41943 30362 90556055
Pericardial effusion 85.16 12.07 95 41935 36738 90549679
Duodenal ulcer perforation 82.63 12.07 5 42025 221283 90365134
Body mass index abnormal 82.59 12.07 25 42005 714 90585703
Cardiac failure 81.56 12.07 166 41864 109330 90477087
Off label use 78.89 12.07 818 41212 1101434 89484983
Folliculitis 78.21 12.07 4 42026 204349 90382068
Serositis 75.92 12.07 27 42003 1290 90585127
Alanine aminotransferase increased 71.66 12.07 165 41865 118173 90468244
Hepatic steatosis 71.56 12.07 87 41943 36858 90549559
Irritable bowel syndrome 70.96 12.07 7 42023 207441 90378976
Central nervous system lupus 67.58 12.07 25 42005 1338 90585079
Metabolic acidosis 64.02 12.07 102 41928 55574 90530843
Urticarial vasculitis 62.43 12.07 22 42008 1023 90585394
Pancytopenia 62.42 12.07 158 41872 120105 90466312
Type 2 diabetes mellitus 61.91 12.07 10 42020 203234 90383183
Gouty tophus 61.79 12.07 16 42014 253 90586164
Joint injury 61.77 12.07 76 41954 32588 90553829
Rash pruritic 61.64 12.07 125 41905 82089 90504328
Granuloma 57.95 12.07 36 41994 6149 90580268
Muscle injury 57.77 12.07 7 42023 176647 90409770
Lower respiratory tract infection 57.73 12.07 22 42008 250637 90335780
Gastric disorder 57.29 12.07 74 41956 33310 90553107
Leukocytosis 55.23 12.07 70 41960 30920 90555497
Ill-defined disorder 54.33 12.07 10 42020 184881 90401536
Hypersensitivity vasculitis 54.27 12.07 30 42000 4129 90582288
Defaecation disorder 53.38 12.07 19 42011 910 90585507
Echocardiogram abnormal 53.33 12.07 22 42008 1577 90584840
Lupus nephritis 52.69 12.07 31 41999 4801 90581616
Injury 51.31 12.07 14 42016 197335 90389082
Cardiac failure congestive 50.52 12.07 129 41901 98565 90487852
Bursitis 49.06 12.07 3 42027 131651 90454766
Blood cholesterol increased 48.32 12.07 18 42012 207994 90378423
Disseminated intravascular coagulation 47.14 12.07 54 41976 21484 90564933
Renal impairment 46.10 12.07 130 41900 105291 90481126
Cardiac tamponade 45.85 12.07 30 42000 5602 90580815
Impaired healing 45.52 12.07 26 42004 234173 90352244
Confusional state 43.49 12.07 70 41960 386135 90200282
Systemic lupus erythematosus 43.24 12.07 63 41967 361833 90224584
Appetite disorder 43.16 12.07 35 41995 9098 90577319
Blood pressure systolic increased 42.89 12.07 88 41942 58257 90528160
Maternal exposure during pregnancy 42.70 12.07 63 41967 360000 90226417
Memory impairment 42.68 12.07 19 42011 197225 90389192
Fibromyalgia 41.39 12.07 22 42008 206247 90380170
Drug intolerance 40.67 12.07 350 41680 447241 90139176
Red blood cell sedimentation rate increased 40.25 12.07 106 41924 82489 90503928
Swelling 40.03 12.07 84 41946 418974 90167443
Overdose 39.27 12.07 161 41869 157548 90428869
Wound 38.95 12.07 50 41980 302930 90283487
Rheumatoid lung 38.74 12.07 24 42006 4079 90582338
Serum amyloid A protein increased 38.70 12.07 14 42016 703 90585714
Drug tolerance decreased 38.50 12.07 60 41970 32070 90554347
Sleep disorder 38.46 12.07 22 42008 198008 90388409
Disease recurrence 37.92 12.07 65 41965 37588 90548829
Neuromyopathy 37.53 12.07 14 42016 767 90585650
Chondrocalcinosis 37.14 12.07 17 42013 1568 90584849
Wheezing 36.44 12.07 34 41996 238046 90348371
Chronic kidney disease 36.06 12.07 75 41955 50116 90536301
Sinusitis 36.03 12.07 65 41965 343023 90243394
Stomatitis 35.65 12.07 45 41985 274653 90311764
Lip dry 35.60 12.07 3 42027 100952 90485465
Malignant neoplasm progression 35.52 12.07 4 42026 106866 90479551
Episcleritis 35.09 12.07 15 42015 1175 90585242
Discomfort 33.50 12.07 47 41983 274288 90312129
Abdominal pain 33.12 12.07 304 41726 395417 90191000
Erythema 31.54 12.07 198 41832 229048 90357369
Asthma 31.07 12.07 40 41990 242120 90344297
Intentional overdose 31.05 12.07 105 41925 93729 90492688
Wound infection 30.73 12.07 6 42024 106396 90480021
Enterococcal sepsis 30.70 12.07 15 42015 1601 90584816
Familial mediterranean fever 30.65 12.07 7 42023 63 90586354
Rebound effect 30.36 12.07 29 42001 9355 90577062
Gait inability 30.30 12.07 15 42015 146441 90439976
Pneumonia 30.23 12.07 173 41857 637886 89948531
Drug hypersensitivity 30.09 12.07 338 41692 463271 90123146
International normalised ratio increased 29.76 12.07 67 41963 47249 90539168
Faeces soft 29.75 12.07 26 42004 7485 90578932
Therapy non-responder 29.74 12.07 134 41896 136570 90449847
Anxiety 29.64 12.07 62 41968 309710 90276707
Conjunctival haemorrhage 29.49 12.07 20 42010 3964 90582453
Blood creatine phosphokinase increased 29.47 12.07 55 41975 33968 90552449
Nasopharyngitis 29.35 12.07 94 41936 407010 90179407
Skin disorder 28.93 12.07 57 41973 36649 90549768
Febrile neutropenia 28.78 12.07 19 42011 158330 90428087
Peripheral venous disease 28.25 12.07 3 42027 83918 90502499
Blood creatine phosphokinase decreased 28.05 12.07 11 42019 691 90585726
Musculoskeletal disorder 27.98 12.07 42 41988 21727 90564690
Medical device site abscess 27.33 12.07 8 42022 203 90586214
Medical device site cellulitis 26.79 12.07 8 42022 218 90586199
Lymphadenopathy 26.78 12.07 63 41967 45712 90540705
Acute febrile neutrophilic dermatosis 26.73 12.07 18 42012 3527 90582890
Coagulopathy 25.85 12.07 42 41988 23247 90563170
Intentional product use issue 25.64 12.07 38 41992 216854 90369563
Iodine allergy 25.57 12.07 11 42019 875 90585542
Road traffic accident 25.52 12.07 9 42021 107617 90478800
Arthralgia 25.41 12.07 504 41526 778018 89808399
Prescribed overdose 25.22 12.07 7 42023 97618 90488799
Neutrophilic dermatosis 24.93 12.07 8 42022 278 90586139
Neutrophilia 24.92 12.07 21 42009 5757 90580660
Eosinophilic pleural effusion 24.90 12.07 7 42023 153 90586264
Sciatica 24.87 12.07 8 42022 101374 90485043
Obesity 24.71 12.07 9 42021 105498 90480919
Pharyngitis streptococcal 24.66 12.07 30 42000 12712 90573705
Leukopenia 24.42 12.07 102 41928 100608 90485809
Tendinous contracture 24.40 12.07 7 42023 165 90586252
Eosinophilic pneumonia acute 24.40 12.07 10 42020 705 90585712
Arthropathy 24.06 12.07 88 41942 366154 90220263
Dizziness 23.68 12.07 168 41862 589116 89997301
Ileal ulcer 23.62 12.07 11 42019 1055 90585362
Nausea 23.50 12.07 677 41353 1109639 89476778
Toxic cardiomyopathy 23.48 12.07 8 42022 336 90586081
C-reactive protein abnormal 23.43 12.07 119 41911 127310 90459107
Labelled drug-drug interaction issue 23.35 12.07 14 42016 2244 90584173
Epilepsy 22.98 12.07 5 42025 82201 90504216
Microstomia 22.76 12.07 5 42025 37 90586380
Blood creatinine increased 22.51 12.07 100 41930 101286 90485131
Heart rate abnormal 22.32 12.07 20 42010 5951 90580466
Loss of personal independence in daily activities 22.22 12.07 123 41907 135982 90450435
Lower limb fracture 22.14 12.07 6 42024 85007 90501410
Hepatic cytolysis 21.97 12.07 46 41984 30870 90555547
Dysphoria 21.80 12.07 20 42010 6134 90580283
Parotid gland enlargement 21.74 12.07 10 42020 933 90585484
Live birth 21.73 12.07 5 42025 79102 90507315
Pleurisy 21.69 12.07 24 42006 9193 90577224
Haematuria 21.44 12.07 49 41981 34888 90551529
Knee arthroplasty 21.42 12.07 6 42024 83176 90503241
Amnesia 21.14 12.07 12 42018 108493 90477924
Injection site oedema 21.05 12.07 12 42018 1751 90584666
Acarodermatitis 20.88 12.07 11 42019 1375 90585042
Drug tolerance 20.83 12.07 33 41997 17883 90568534
Allergy to metals 20.80 12.07 10 42020 1030 90585387
Bone marrow failure 20.68 12.07 46 41984 32175 90554242
Shock 20.67 12.07 43 41987 28735 90557682
Cardiogenic shock 20.51 12.07 39 41991 24429 90561988
Natural killer cell count 20.28 12.07 4 42026 16 90586401
Amegakaryocytic thrombocytopenia 20.28 12.07 4 42026 16 90586401
Behcet's syndrome 20.15 12.07 5 42025 66 90586351
Prescribed underdose 20.10 12.07 5 42025 75014 90511403
Vasculitis 20.05 12.07 37 41993 22656 90563761
Lung disorder 20.01 12.07 24 42006 149859 90436558
Hyperkalaemia 20.01 12.07 71 41959 64893 90521524
Proteus infection 19.89 12.07 11 42019 1515 90584902
Blood pressure systolic decreased 19.88 12.07 23 42007 9247 90577170
Haemorrhagic diathesis 19.66 12.07 18 42012 5506 90580911
Musculoskeletal pain 19.28 12.07 31 41999 171220 90415197
Spondyloarthropathy 19.26 12.07 10 42020 1214 90585203
C-reactive protein increased 19.22 12.07 147 41883 181242 90405175
Gouty arthritis 19.20 12.07 8 42022 588 90585829
Renal failure 19.17 12.07 115 41915 130892 90455525
Arthritis infective 19.13 12.07 21 42009 7971 90578446
Macrophages increased 19.08 12.07 4 42026 23 90586394
Acute abdomen 19.01 12.07 11 42019 1652 90584765
Respiratory acidosis 18.86 12.07 21 42009 8098 90578319
Gastrooesophageal reflux disease 18.83 12.07 30 42000 166307 90420110
HCoV-HKU1 infection 18.79 12.07 4 42026 25 90586392
Myalgia 18.60 12.07 142 41888 174983 90411434
Accidental exposure to product by child 18.46 12.07 10 42020 1323 90585094
Therapy partial responder 18.31 12.07 35 41995 22008 90564409
Myocarditis 18.26 12.07 27 42003 13779 90572638
Osteomyelitis 18.15 12.07 40 41990 27806 90558611
White blood cell count decreased 18.12 12.07 31 41999 167078 90419339
Cholestasis 18.10 12.07 47 41983 36252 90550165
Axillary pain 18.01 12.07 12 42018 2309 90584108
Foot deformity 18.01 12.07 3 42027 59648 90526769
Depression 17.96 12.07 75 41955 300526 90285891
Hypotension 17.91 12.07 230 41800 325167 90261250
Maternal exposure during breast feeding 17.85 12.07 18 42012 6202 90580215
Pericardial haemorrhage 17.78 12.07 11 42019 1865 90584552
Drug abuse 17.70 12.07 8 42022 82339 90504078
Chondrocalcinosis pyrophosphate 17.68 12.07 9 42021 1049 90585368
Hypertriglyceridaemia 17.64 12.07 20 42010 7869 90578548
Cutaneous vasculitis 17.39 12.07 19 42011 7174 90579243
Hyperaesthesia 17.24 12.07 23 42007 10679 90575738
White blood cells urine positive 17.19 12.07 18 42012 6480 90579937
Inflammation 16.88 12.07 141 41889 178451 90407966
Seizure 16.84 12.07 28 42002 152601 90433816
Completed suicide 16.76 12.07 120 41910 144938 90441479
Migraine 16.65 12.07 40 41990 190352 90396065
Eye haemorrhage 16.58 12.07 22 42008 10158 90576259
Rash maculo-papular 16.46 12.07 49 41981 40884 90545533
Dyspepsia 16.27 12.07 43 41987 198117 90388300
Alopecia 16.25 12.07 149 41881 494922 90091495
Eye symptom 16.10 12.07 5 42025 156 90586261
Therapeutic response decreased 15.94 12.07 83 41947 89646 90496771
Autoimmune disorder 15.66 12.07 8 42022 76736 90509681
Liver injury 15.59 12.07 35 41995 170532 90415885
Hypergammaglobulinaemia benign monoclonal 15.51 12.07 8 42022 958 90585459
Keratomileusis 15.39 12.07 5 42025 181 90586236
N-terminal prohormone brain natriuretic peptide increased 15.38 12.07 12 42018 2950 90583467
Pericarditis fungal 15.35 12.07 4 42026 65 90586352
Hepatosplenomegaly 15.22 12.07 12 42018 2997 90583420
Mucosal inflammation 15.13 12.07 4 42026 57621 90528796
Cutaneous tuberculosis 15.03 12.07 5 42025 195 90586222
Blister 15.00 12.07 64 41966 254934 90331483
Hepatocellular injury 14.96 12.07 38 41992 28920 90557497
Wrong product administered 14.76 12.07 18 42012 7647 90578770
Arthritis 14.71 12.07 130 41900 167185 90419232
Delirium 14.70 12.07 16 42014 104343 90482074
Hepatic function abnormal 14.61 12.07 51 41979 46237 90540180
Enterococcal bacteraemia 14.58 12.07 10 42020 2018 90584399
Lactic acidosis 14.57 12.07 54 41976 50409 90536008
Hepatic failure 14.52 12.07 46 41984 39682 90546735
Grip strength decreased 14.41 12.07 13 42017 92563 90493854
Skin irritation 14.38 12.07 24 42006 13579 90572838
Hernia hiatus repair 14.30 12.07 5 42025 227 90586190
Acute generalised exanthematous pustulosis 14.25 12.07 24 42006 13679 90572738
Meningocele 14.20 12.07 3 42027 18 90586399
Angiopathy 14.17 12.07 15 42015 5465 90580952
Umbilical hernia repair 13.98 12.07 5 42025 243 90586174
Nail disorder 13.90 12.07 5 42025 59062 90527355
Product quality issue 13.77 12.07 10 42020 79315 90507102
Sexual inhibition 13.68 12.07 3 42027 22 90586395
Blood pressure diastolic decreased 13.65 12.07 35 41995 26791 90559626
Vascular purpura 13.52 12.07 9 42021 1729 90584688
Mobility decreased 13.51 12.07 65 41965 250669 90335748
Cardiac dysfunction 13.35 12.07 12 42018 3585 90582832
Suicidal ideation 13.23 12.07 9 42021 73846 90512571
Pericardial drainage 13.21 12.07 5 42025 285 90586132
Treatment failure 13.17 12.07 206 41824 303722 90282695
Autoinflammatory disease 13.13 12.07 5 42025 290 90586127
Body temperature decreased 13.09 12.07 32 41998 23784 90562633
Frequent bowel movements 13.09 12.07 5 42025 56930 90529487
Multiple sclerosis relapse 13.05 12.07 4 42026 52301 90534116
Pericarditis infective 12.96 12.07 4 42026 122 90586295
Seasonal allergy 12.76 12.07 31 41999 22952 90563465
Back injury 12.70 12.07 3 42027 46619 90539798
Polyarteritis nodosa 12.62 12.07 5 42025 323 90586094
Tenderness 12.60 12.07 34 41996 26834 90559583
Hypercholesterolaemia 12.59 12.07 17 42013 100875 90485542
Myopathy toxic 12.57 12.07 6 42024 608 90585809
Onychomadesis 12.45 12.07 3 42027 45995 90540422
Type IV hypersensitivity reaction 12.45 12.07 12 42018 3914 90582503
Incorrect route of product administration 12.40 12.07 4 42026 50622 90535795
Symptom recurrence 12.37 12.07 12 42018 3947 90582470
Presbyopia 12.34 12.07 6 42024 634 90585783
Hepatic cirrhosis 12.31 12.07 7 42023 63246 90523171
Depressed mood 12.25 12.07 4 42026 50218 90536199
Dry mouth 12.22 12.07 44 41986 184015 90402402
Carotidynia 12.20 12.07 4 42026 149 90586268
Dermatitis exfoliative generalised 12.20 12.07 14 42016 5579 90580838
Haemophagocytic lymphohistiocytosis 12.17 12.07 24 42006 15435 90570982
Left ventricular dilatation 12.12 12.07 6 42024 659 90585758

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
Gout 354.45 11.86 258 40328 27797 42552952
Rhabdomyolysis 234.17 11.86 328 40258 77691 42503058
Toxicity to various agents 184.63 11.86 557 40029 228579 42352170
Drug interaction 172.64 11.86 602 39984 266397 42314352
Myopathy 163.45 11.86 122 40464 13639 42567110
Pericarditis 161.49 11.86 120 40466 13324 42567425
Tenosynovitis 158.19 11.86 81 40505 4614 42576135
Acute kidney injury 156.43 11.86 727 39859 366610 42214139
Enthesopathy 153.19 11.86 80 40506 4748 42576001
Neuromyopathy 135.24 11.86 48 40538 1086 42579663
Tongue disorder 131.42 11.86 75 40511 5308 42575441
Diarrhoea 120.24 11.86 799 39787 460050 42120699
Multiple organ dysfunction syndrome 106.97 11.86 265 40321 96770 42483979
C-reactive protein abnormal 96.57 11.86 76 40510 9185 42571564
Drug reaction with eosinophilia and systemic symptoms 85.60 11.86 148 40438 41927 42538822
Alanine aminotransferase abnormal 84.93 11.86 55 40531 4889 42575860
Synovitis 78.33 11.86 85 40501 15482 42565267
Tendonitis 75.87 11.86 68 40518 9826 42570923
Cardiogenic shock 74.64 11.86 127 40459 35513 42545236
Overdose 70.02 11.86 240 40346 105024 42475725
Drug ineffective for unapproved indication 66.25 11.86 140 40446 46023 42534726
Metabolic acidosis 61.77 11.86 146 40440 51712 42529037
Myopathy toxic 61.35 11.86 24 40562 717 42580032
Drug abuse 60.37 11.86 13 40573 104758 42475991
Serum amyloid A protein increased 54.39 11.86 17 40569 255 42580494
Renal failure 52.60 11.86 273 40313 143453 42437296
Pericardial effusion 50.64 11.86 96 40490 29179 42551570
Intentional overdose 49.90 11.86 134 40452 51322 42529427
Aspartate aminotransferase increased 47.89 11.86 172 40414 76991 42503758
Scleroderma renal crisis 46.68 11.86 17 40569 415 42580334
Red blood cell sedimentation rate 46.42 11.86 22 40564 1058 42579691
Granuloma skin 44.66 11.86 22 40564 1153 42579596
Malignant neoplasm progression 44.29 11.86 24 40562 108376 42472373
Panniculitis 41.79 11.86 26 40560 2155 42578594
Gouty tophus 38.46 11.86 12 40574 179 42580570
Shock 37.98 11.86 85 40501 29036 42551713
Leukocytosis 37.95 11.86 86 40500 29622 42551127
Blood parathyroid hormone decreased 37.73 11.86 22 40564 1621 42579128
Death 37.49 11.86 279 40307 470906 42109843
Mixed liver injury 36.79 11.86 32 40554 4442 42576307
Treatment failure 35.83 11.86 136 40450 62488 42518261
Gouty arthritis 35.16 11.86 19 40567 1208 42579541
Completed suicide 34.40 11.86 182 40404 96283 42484466
Ulcer 33.64 11.86 58 40528 16383 42564366
Pericarditis constrictive 32.50 11.86 14 40572 537 42580212
Alanine aminotransferase increased 32.35 11.86 168 40418 88238 42492511
Familial mediterranean fever 31.08 11.86 8 40578 56 42580693
Muscle abscess 30.97 11.86 16 40570 928 42579821
Drug intolerance 30.94 11.86 155 40431 80269 42500480
Cardiac tamponade 29.95 11.86 34 40552 6506 42574243
Febrile neutropenia 29.67 11.86 85 40501 185618 42395131
Seizure 29.64 11.86 43 40543 120518 42460231
Therapeutic response decreased 28.72 11.86 89 40497 36923 42543826
Musculoskeletal toxicity 27.97 11.86 9 40577 149 42580600
Aggression 26.42 11.86 5 40581 44158 42536591
Pericardial haemorrhage 26.32 11.86 24 40562 3545 42577204
Rheumatoid nodule 25.80 11.86 22 40564 2973 42577776
Myalgia 25.66 11.86 168 40418 95912 42484837
Spermatozoa progressive motility decreased 25.09 11.86 9 40577 210 42580539
Agranulocytosis 25.05 11.86 75 40511 30537 42550212
Pericarditis adhesive 25.02 11.86 5 40581 8 42580741
Disease progression 25.02 11.86 63 40523 143593 42437156
Pericardial calcification 24.70 11.86 6 40580 32 42580717
Contraindicated product administered 24.67 11.86 66 40520 25206 42555543
Hypertrophic osteoarthropathy 23.91 11.86 7 40579 83 42580666
Cellulitis 23.90 11.86 119 40467 61466 42519283
Growth retardation 23.31 11.86 19 40567 2413 42578336
Myocarditis 23.27 11.86 54 40532 18884 42561865
Pulmonary embolism 22.79 11.86 50 40536 119562 42461187
Cholestasis 22.73 11.86 76 40510 32803 42547946
Herbal interaction 22.41 11.86 10 40576 418 42580331
Blood uric acid increased 22.11 11.86 47 40539 15500 42565249
Pneumonia streptococcal 22.04 11.86 16 40570 1712 42579037
Erythema 22.01 11.86 178 40408 108615 42472134
Foetal exposure during pregnancy 21.57 11.86 9 40577 47302 42533447
Hepatitis acute 21.50 11.86 34 40552 8941 42571808
Secondary adrenocortical insufficiency 21.39 11.86 17 40569 2082 42578667
Pleuropericarditis 21.17 11.86 9 40577 334 42580415
Pericardial mesothelioma malignant 21.06 11.86 4 40582 4 42580745
Drug hypersensitivity 20.86 11.86 164 40422 99225 42481524
Cardiac vein perforation 20.85 11.86 5 40581 25 42580724
Loss of personal independence in daily activities 20.57 11.86 98 40488 49718 42531031
Acute hepatic failure 20.24 11.86 48 40538 17025 42563724
Myositis 20.07 11.86 44 40542 14822 42565927
Lymph nodes scan abnormal 19.18 11.86 5 40581 37 42580712
Rebound effect 19.14 11.86 29 40557 7350 42573399
Thrombocytopenic purpura 18.91 11.86 13 40573 1276 42579473
Therapy non-responder 18.55 11.86 100 40486 53259 42527490
Somnolence 18.13 11.86 71 40515 141034 42439715
Stomatitis 17.98 11.86 13 40573 50316 42530433
Vasoplegia syndrome 17.93 11.86 17 40569 2638 42578111
Meningitis gonococcal 17.87 11.86 3 40583 0 42580749
Biopsy muscle abnormal 17.87 11.86 3 40583 0 42580749
Pericardial cyst 17.83 11.86 4 40582 14 42580735
Heart sounds abnormal 17.82 11.86 11 40575 899 42579850
Myocardial rupture 17.80 11.86 7 40579 212 42580537
Osteoporosis 17.77 11.86 42 40544 14864 42565885
Liver injury 17.68 11.86 49 40537 19099 42561650
Mouth ulceration 17.66 11.86 42 40544 14921 42565828
Bradycardia foetal 17.42 11.86 8 40578 358 42580391
Platelet count decreased 17 11.86 71 40515 138510 42442239
Secondary amyloidosis 16.81 11.86 6 40580 138 42580611
Psoriatic arthropathy 16.63 11.86 57 40529 24910 42555839
Glucose tolerance impaired 16.49 11.86 20 40566 4104 42576645
Scrotal erythema 16.45 11.86 5 40581 68 42580681
Muscle necrosis 16.43 11.86 11 40575 1034 42579715
Blood creatine phosphokinase increased 16.40 11.86 90 40496 48248 42532501
Mixed dementia 16.29 11.86 7 40579 267 42580482
Thrombocytopenia 16.27 11.86 263 40323 190016 42390733
Hepatic cytolysis 15.93 11.86 59 40527 26785 42553964
Vomiting 15.80 11.86 374 40212 289349 42291400
Sinus arrhythmia 15.66 11.86 10 40576 867 42579882
Arthralgia 15.48 11.86 278 40308 204960 42375789
Skin necrosis 15.24 11.86 24 40562 6290 42574459
Pneumonia 15.23 11.86 297 40289 421852 42158897
Hypocalcaemia 15.21 11.86 63 40523 30110 42550639
Neutrophil count decreased 15.20 11.86 23 40563 63392 42517357
Subperiosteal abscess 15.10 11.86 5 40581 91 42580658
Hepatic failure 15.04 11.86 74 40512 38026 42542723
Penile discomfort 14.76 11.86 4 40582 35 42580714
Chronic kidney disease 14.74 11.86 86 40500 47155 42533594
Skin hyperpigmentation 14.68 11.86 19 40567 4162 42576587
Insulin autoimmune syndrome 14.57 11.86 8 40578 525 42580224
Disseminated coccidioidomycosis 14.39 11.86 5 40581 106 42580643
Vascular cognitive impairment 14.28 11.86 4 40582 40 42580709
Hepatosplenomegaly neonatal 14.28 11.86 4 40582 40 42580709
Stevens-Johnson syndrome 14.22 11.86 50 40536 22128 42558621
Neoplasm progression 14.08 11.86 5 40581 28995 42551754
Vasospasm 13.86 11.86 8 40578 578 42580171
Renal vasculitis 13.81 11.86 6 40580 235 42580514
Pancytopenia 13.77 11.86 172 40414 117571 42463178
Carditis 13.74 11.86 6 40580 238 42580511
Gastrointestinal disorder 13.32 11.86 83 40503 46570 42534179
Cardiac failure congestive 13.17 11.86 132 40454 85470 42495279
Allergic eosinophilia 13.12 11.86 4 40582 55 42580694
Acute respiratory failure 12.95 11.86 72 40514 38786 42541963
Drug-disease interaction 12.79 11.86 9 40577 917 42579832
Disease recurrence 12.70 11.86 59 40527 29619 42551130
Restlessness 12.65 11.86 6 40580 29243 42551506
Serositis 12.50 11.86 6 40580 297 42580452
Obstructive airways disorder 12.49 11.86 4 40582 24755 42555994
Coronary artery thrombosis 12.41 11.86 13 40573 2273 42578476
Eosinophilia 12.35 11.86 63 40523 32836 42547913
Hepatic enzyme increased 12.18 11.86 80 40506 45704 42535045
Metastases to spleen 12.18 11.86 7 40579 502 42580247
Agitation 12.14 11.86 27 40559 64287 42516462
Dysarthria 12.11 11.86 12 40574 39795 42540954
Pericardial fibrosis 12.06 11.86 5 40581 174 42580575
Spider vein 12.04 11.86 5 40581 175 42580574
Suicidal ideation 12.00 11.86 17 40569 48144 42532605
Chronic left ventricular failure 11.93 11.86 8 40578 754 42579995

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
Gout 610.86 10.98 350 72644 36216 110480089
Toxicity to various agents 423.18 10.98 960 72034 479595 110036710
Rhabdomyolysis 366.21 10.98 424 72570 119977 110396328
Acute kidney injury 361.10 10.98 1077 71917 634353 109881952
Enthesopathy 353.05 10.98 170 72824 12308 110503997
Tenosynovitis 327.00 10.98 176 72818 16107 110500198
Drug interaction 309.07 10.98 874 72120 499309 110016996
Tongue disorder 294.00 10.98 157 72837 14141 110502164
Myopathy 293.72 10.98 191 72803 24769 110491536
Diarrhoea 240.23 10.98 1424 71570 1138081 109378224
Tendonitis 225.28 10.98 165 72829 25918 110490387
Multiple organ dysfunction syndrome 218.16 10.98 373 72621 151337 110364968
Drug reaction with eosinophilia and systemic symptoms 213.31 10.98 267 72727 81828 110434477
Alanine aminotransferase abnormal 198.98 10.98 105 72889 9229 110507076
Panniculitis 192.60 10.98 123 72871 15459 110500846
Red blood cell sedimentation rate 191.06 10.98 85 72909 5129 110511176
Drug ineffective for unapproved indication 187.82 10.98 282 72712 102556 110413749
Neuromyopathy 177.22 10.98 60 72934 1719 110514586
Blood parathyroid hormone decreased 173.49 10.98 108 72886 12981 110503324
Granuloma skin 154.37 10.98 95 72899 11188 110505117
Loss of employment 140.39 10.98 60 72934 3284 110513021
Skin necrosis 135.65 10.98 113 72881 21399 110494906
Rheumatoid nodule 135.07 10.98 110 72884 20186 110496119
Metabolic acidosis 132.61 10.98 237 72757 99507 110416798
Glossodynia 132.01 10.98 3 72991 222001 110294304
Pericardial effusion 125.14 10.98 171 72823 57046 110459259
Overdose 119.84 10.98 383 72611 233411 110282894
Aspartate aminotransferase increased 117.07 10.98 298 72696 159638 110356667
Hand deformity 113.22 10.98 8 72986 218498 110297807
Cardiogenic shock 111.51 10.98 162 72832 57176 110459129
Ulcer 106.84 10.98 137 72857 42979 110473326
Anti-cyclic citrullinated peptide antibody positive 106.14 10.98 3 72991 181981 110334324
Basal cell carcinoma 95.54 10.98 133 72861 45137 110471168
Duodenal ulcer perforation 93.54 10.98 6 72988 177694 110338611
Gouty tophus 92.74 10.98 27 72967 464 110515841
Alanine aminotransferase increased 89.57 10.98 296 72698 183477 110332828
Hypercalcaemia 89.53 10.98 131 72863 46526 110469779
Leukocytosis 87.59 10.98 140 72854 53688 110462617
Fear of injection 87.58 10.98 61 72933 8850 110507455
Renal failure 85.78 10.98 336 72658 226238 110290067
Skin ulcer 83.00 10.98 150 72844 63495 110452810
Cardiac tamponade 81.02 10.98 64 72930 11243 110505062
Intentional overdose 80.96 10.98 231 72763 132270 110384035
Serum amyloid A protein increased 79.23 10.98 28 72966 914 110515391
Pancytopenia 77.84 10.98 309 72685 209304 110307001
Irritable bowel syndrome 77.06 10.98 9 72985 164206 110352099
Folliculitis 76.69 10.98 10 72984 167643 110348662
Drug eruption 75.83 10.98 131 72863 53528 110462777
Rheumatoid factor positive 73.84 10.98 3 72991 131637 110384668
Maternal exposure during pregnancy 73.82 10.98 38 72956 254845 110261460
Serositis 72.03 10.98 30 72964 1539 110514766
Myopathy toxic 69.93 10.98 28 72966 1297 110515008
Lower respiratory tract infection 69.28 10.98 37 72957 243069 110273236
Impaired healing 68.87 10.98 22 72972 196695 110319610
Body mass index abnormal 68.34 10.98 25 72969 903 110515402
Off label use 66.32 10.98 1371 71623 1498814 109017491
Drug abuse 63.61 10.98 19 72975 177392 110338913
Ill-defined disorder 63.61 10.98 13 72981 156840 110359465
Stomatitis 62.39 10.98 52 72942 270190 110246115
Shock 60.80 10.98 119 72875 53469 110462836
Familial mediterranean fever 60.27 10.98 16 72978 192 110516113
Systemic lupus erythematosus 59.88 10.98 48 72946 254290 110262015
Cardiac failure congestive 59.63 10.98 227 72767 150773 110365532
Central nervous system lupus 59.20 10.98 25 72969 1328 110514977
Fibromyalgia 58.27 10.98 20 72974 170889 110345416
Sinusitis 58.16 10.98 66 72928 296622 110219683
Cardiac failure 56.81 10.98 260 72734 187366 110328939
Type 2 diabetes mellitus 56.63 10.98 23 72971 177209 110339096
Muscle injury 56.42 10.98 12 72982 140795 110375510
Completed suicide 55.87 10.98 311 72683 242070 110274235
Chronic kidney disease 52.55 10.98 139 72855 76152 110440153
Malignant neoplasm progression 52.08 10.98 25 72969 174542 110341763
Rash pruritic 51.41 10.98 162 72832 97907 110418398
Gouty arthritis 51.19 10.98 24 72970 1635 110514670
Epilepsy 50.95 10.98 4 72990 100205 110416100
Lip dry 50.87 10.98 4 72990 100079 110416226
Disease recurrence 50.55 10.98 119 72875 60665 110455640
Gastric disorder 50.52 10.98 84 72910 33273 110483032
Therapy non-responder 49.87 10.98 221 72773 157086 110359219
Blood cholesterol increased 48.56 10.98 31 72963 184754 110331551
Blood creatine phosphokinase increased 48.17 10.98 131 72863 72946 110443359
Erythema 47.31 10.98 342 72652 291105 110225200
Cholestasis 46.95 10.98 120 72874 64398 110451907
Injury 46.23 10.98 30 72964 177235 110339070
Lupus nephritis 46.12 10.98 32 72962 4613 110511692
Granuloma 46.11 10.98 43 72951 9447 110506858
Confusional state 46.03 10.98 157 72837 468523 110047782
Defaecation disorder 45.10 10.98 18 72976 827 110515478
Disseminated intravascular coagulation 44.80 10.98 90 72904 41196 110475109
Rebound effect 44.71 10.98 52 72942 14754 110501551
Wheezing 44.57 10.98 62 72932 255168 110261137
Rheumatoid lung 43.56 10.98 30 72964 4274 110512031
Joint injury 43.18 10.98 87 72907 39907 110476398
Pericardial haemorrhage 42.79 10.98 32 72962 5185 110511120
Myalgia 42.06 10.98 271 72723 222110 110294195
Peripheral venous disease 41.02 10.98 4 72990 84113 110432192
Drug intolerance 40.82 10.98 429 72565 406083 110110222
Scleroderma renal crisis 40.20 10.98 17 72977 906 110515399
Bursitis 39.68 10.98 18 72976 129900 110386405
Treatment failure 39.20 10.98 315 72679 276919 110239386
Asthma 38.72 10.98 66 72928 250225 110266080
Febrile neutropenia 38.45 10.98 96 72898 316671 110199634
Myocarditis 38.12 10.98 70 72924 29985 110486320
Nasopharyngitis 38.10 10.98 133 72861 394228 110122077
Hepatic steatosis 37.81 10.98 93 72901 48738 110467567
Lung disorder 37.56 10.98 38 72956 180009 110336296
Memory impairment 37.31 10.98 45 72949 196899 110319406
Wound infection 37.08 10.98 9 72985 96456 110419849
C-reactive protein abnormal 36.51 10.98 176 72818 129519 110386786
Accidental exposure to product by child 36.46 10.98 24 72970 3174 110513131
Seizure 36.39 10.98 56 72938 221129 110295176
Anxiety 36.36 10.98 112 72882 344966 110171339
Leukopenia 36.34 10.98 194 72800 148597 110367708
Growth retardation 35.98 10.98 22 72972 2560 110513745
Sleep disorder 35.94 10.98 47 72947 198597 110317708
Blood creatinine increased 35.89 10.98 225 72769 182664 110333641
Wound 35.19 10.98 63 72931 234374 110281931
Episcleritis 35.06 10.98 17 72977 1249 110515056
Coagulopathy 35.00 10.98 81 72913 40830 110475475
Loss of personal independence in daily activities 34.88 10.98 193 72801 149827 110366478
Obesity 34.16 10.98 16 72978 113335 110402970
Drug resistance 34.14 10.98 98 72896 56276 110460029
Pneumonia 33.85 10.98 393 72601 876321 109639984
Thrombocytopenia 33.52 10.98 365 72629 348520 110167785
Abdominal pain 33.29 10.98 499 72495 512490 110003815
Echocardiogram abnormal 32.77 10.98 21 72973 2653 110513652
Hepatic cytolysis 32.66 10.98 95 72899 54958 110461347
Live birth 32.12 10.98 4 72990 69480 110446825
Depression 32.02 10.98 105 72889 317230 110199075
Pericarditis constrictive 32.02 10.98 15 72979 1020 110515285
Hepatic failure 31.94 10.98 109 72885 68630 110447675
Spermatozoa progressive motility decreased 31.63 10.98 9 72985 142 110516163
Intentional product use issue 30.96 10.98 74 72920 247832 110268473
Hypoaesthesia 30.32 10.98 106 72888 314117 110202188
Musculoskeletal disorder 30.29 10.98 54 72940 22610 110493695
International normalised ratio increased 29.86 10.98 125 72869 86647 110429658
Muscle abscess 29.83 10.98 16 72978 1453 110514852
Migraine 28.67 10.98 43 72951 171609 110344696
Pleuropericarditis 28.02 10.98 12 72982 660 110515645
Sedation 27.78 10.98 6 72988 69677 110446628
Mixed liver injury 27.77 10.98 37 72957 12042 110504263
Musculoskeletal toxicity 27.74 10.98 9 72985 225 110516080
Blister 27.51 10.98 69 72925 227307 110288998
Appetite disorder 27.33 10.98 33 72961 9736 110506569
Dizziness 26.91 10.98 313 72681 697880 109818425
Hepatocellular injury 26.85 10.98 84 72910 50558 110465747
Pericarditis adhesive 26.85 10.98 5 72989 8 110516297
Swelling 26.64 10.98 130 72864 350911 110165394
Sciatica 26.40 10.98 14 72980 92385 110423920
Neutrophilia 25.86 10.98 33 72961 10296 110506009
Therapeutic response decreased 25.76 10.98 129 72865 96370 110419935
Blepharospasm 25.74 10.98 3 72991 54848 110461457
Arthralgia 25.73 10.98 685 72309 778947 109737358
Suicide attempt 25.37 10.98 135 72859 103259 110413046
Lower limb fracture 25.36 10.98 9 72985 75339 110440966
Discomfort 25.32 10.98 66 72928 214641 110301664
Medical device site abscess 24.58 10.98 8 72986 202 110516103
Agranulocytosis 24.49 10.98 93 72901 61667 110454638
Eosinophilia 24.44 10.98 89 72905 57847 110458458
Renal impairment 24.42 10.98 210 72784 188235 110328070
Enterococcal sepsis 24.27 10.98 19 72975 3293 110513012
Prescribed overdose 23.97 10.98 14 72980 87567 110428738
Arthropathy 23.88 10.98 103 72891 287419 110228886
Medical device site cellulitis 23.84 10.98 8 72986 223 110516082
Hypertrophic osteoarthropathy 23.54 10.98 7 72987 130 110516175
Pregnancy 23.46 10.98 3 72991 51064 110465241
Autoinflammatory disease 23.45 10.98 9 72985 372 110515933
Acute generalised exanthematous pustulosis 23.23 10.98 47 72947 21617 110494688
Knee arthroplasty 23.19 10.98 7 72987 64941 110451364
Hypercholesterolaemia 22.83 10.98 16 72978 90821 110425484
Drug tolerance 22.79 10.98 40 72954 16545 110499760
Cardiac vein perforation 22.68 10.98 5 72989 25 110516280
Herbal interaction 22.28 10.98 10 72984 616 110515689
Faeces soft 22.26 10.98 32 72962 11178 110505127
Skin hyperpigmentation 22.12 10.98 28 72966 8668 110507637
Road traffic accident 22.01 10.98 23 72971 107375 110408930
Lactic acidosis 21.97 10.98 120 72874 92691 110423614
Night sweats 21.95 10.98 34 72960 133949 110382356
Cutaneous vasculitis 21.94 10.98 34 72960 12695 110503610
Foot deformity 21.90 10.98 3 72991 48477 110467828
Drug tolerance decreased 21.90 10.98 53 72941 27487 110488818
Drug hypersensitivity 21.87 10.98 421 72573 453669 110062636
Autoimmune disorder 21.74 10.98 8 72986 65475 110450830
Taste disorder 21.68 10.98 8 72986 65379 110450926
Frequent bowel movements 21.63 10.98 10 72984 71380 110444925
Prescribed underdose 21.57 10.98 8 72986 65166 110451139
Blood pressure systolic increased 21.49 10.98 110 72884 82881 110433424
Pericardial drainage 21.47 10.98 9 72985 469 110515836
Neoplasm progression 21.26 10.98 8 72986 64587 110451718
Back injury 21.26 10.98 3 72991 47396 110468909
Pericardial mesothelioma malignant 21.25 10.98 4 72990 7 110516298
Conjunctival haemorrhage 21.22 10.98 24 72970 6609 110509696
Scrotal erythema 21.00 10.98 5 72989 37 110516268
Microstomia 20.89 10.98 5 72989 38 110516267
Cardiac arrest 20.84 10.98 210 72784 196543 110319762
Chondrocalcinosis 20.48 10.98 14 72980 1971 110514334
Red blood cell sedimentation rate increased 20.43 10.98 104 72890 78198 110438107
Exostosis 20.40 10.98 3 72991 45953 110470352
Product quality issue 20.26 10.98 13 72981 77286 110439019
Onychomadesis 20.22 10.98 3 72991 45660 110470645
Vascular purpura 20.10 10.98 18 72976 3753 110512552
Aggression 20.05 10.98 7 72987 59203 110457102
Amnesia 20.04 10.98 24 72970 105384 110410921
Blood uric acid increased 19.95 10.98 44 72950 21485 110494820
Rash maculo-papular 19.65 10.98 99 72895 74123 110442182
Pericardial calcification 19.32 10.98 5 72989 54 110516251
Heart sounds abnormal 19.06 10.98 12 72982 1470 110514835
Cardiac dysfunction 19.03 10.98 22 72972 6201 110510104
Meningitis gonococcal 18.97 10.98 3 72991 0 110516305
Acute respiratory failure 18.96 10.98 99 72895 75161 110441144
Natural killer cell count 18.87 10.98 4 72990 16 110516289
Hypersensitivity vasculitis 18.71 10.98 23 72971 6914 110509391
Respiratory acidosis 18.55 10.98 33 72961 13793 110502512
Gastrooesophageal reflux disease 18.53 10.98 59 72935 179917 110336388
Obstructive airways disorder 18.35 10.98 4 72990 46145 110470160
Myocardial rupture 18.32 10.98 7 72987 286 110516019
Mixed dementia 18.32 10.98 7 72987 286 110516019
Laryngitis 18.30 10.98 3 72991 42408 110473897
Dry mouth 18.26 10.98 69 72925 199879 110316426
Pruritus 18.25 10.98 272 72722 581288 109935017
Cellulitis 18.24 10.98 144 72850 125872 110390433
Tendinous contracture 18.18 10.98 7 72987 292 110516013
Renal vasculitis 18.17 10.98 9 72985 692 110515613
Skin disorder 18.17 10.98 66 72928 42847 110473458
Bone marrow failure 18.11 10.98 81 72913 57767 110458538
Amegakaryocytic thrombocytopenia 17.98 10.98 4 72990 21 110516284
Heart rate abnormal 17.93 10.98 23 72971 7215 110509090
Chondrocalcinosis pyrophosphate 17.81 10.98 12 72982 1649 110514656
Generalised tonic-clonic seizure 17.62 10.98 7 72987 54673 110461632
Disease progression 17.58 10.98 92 72902 243942 110272363
Atrial fibrillation 17.53 10.98 230 72764 229412 110286893
C-reactive protein increased 17.37 10.98 220 72774 217699 110298606
Pneumonia streptococcal 17.32 10.98 16 72978 3473 110512832
Stevens-Johnson syndrome 17.27 10.98 69 72925 46832 110469473
Behcet's syndrome 17.25 10.98 4 72990 26 110516279
Labelled drug-drug interaction issue 16.95 10.98 17 72977 4084 110512221
Pharyngitis streptococcal 16.93 10.98 31 72963 13246 110503059
Liver dialysis 16.89 10.98 3 72991 3 110516302
Paraesthesia 16.85 10.98 110 72884 276411 110239894
Ileal ulcer 16.84 10.98 12 72982 1805 110514500
Grip strength decreased 16.62 10.98 17 72977 80157 110436148
Injection site oedema 16.62 10.98 12 72982 1842 110514463
Exposure during pregnancy 16.46 10.98 56 72938 167368 110348937
Somnolence 16.32 10.98 122 72872 297327 110218978
Suicidal ideation 16.20 10.98 23 72971 93914 110422391
Dyspepsia 16.10 10.98 68 72926 190897 110325408
Drug ineffective 16.05 10.98 1187 71807 1519353 108996952
Toxic epidermal necrolysis 15.97 10.98 77 72917 56650 110459655
Secondary adrenocortical insufficiency 15.84 10.98 17 72977 4417 110511888
Hypotension 15.76 10.98 455 72539 523394 109992911
Death 15.59 10.98 347 72647 698522 109817783
Urine output decreased 15.54 10.98 38 72956 19838 110496467
Joint range of motion decreased 15.50 10.98 36 72958 121796 110394509
Blood creatine phosphokinase decreased 15.37 10.98 10 72984 1297 110515008
Neutrophil count decreased 15.17 10.98 36 72958 120905 110395400
Vascular cognitive impairment 15.07 10.98 4 72990 48 110516257
Myositis 15.03 10.98 50 72944 31066 110485239
Hyperkalaemia 14.89 10.98 146 72848 135650 110380655
Insulin autoimmune syndrome 14.84 10.98 8 72986 734 110515571
Pulmonary embolism 14.81 10.98 82 72912 214392 110301913
Hepatitis acute 14.80 10.98 36 72958 18730 110497575
Lymph nodes scan abnormal 14.74 10.98 5 72989 144 110516161
Erythema nodosum 14.72 10.98 20 72974 6633 110509672
Muscle necrosis 14.69 10.98 11 72983 1786 110514519
Pericardial cyst 14.57 10.98 4 72990 55 110516250
Gait inability 14.54 10.98 44 72950 136332 110379973
Acute hepatic failure 14.53 10.98 55 72939 36413 110479892
Fall 14.51 10.98 296 72698 603186 109913119
Coronary artery thrombosis 14.43 10.98 14 72980 3230 110513075
Platelet count decreased 14.38 10.98 91 72903 230352 110285953
Eosinophilic pleural effusion 14.35 10.98 7 72987 521 110515784
White blood cells urine positive 14.25 10.98 21 72973 7503 110508802
Keratomileusis 14.18 10.98 5 72989 162 110516143
Labelled drug-drug interaction medication error 14.08 10.98 47 72947 29255 110487050
Aphasia 14.04 10.98 11 72983 58986 110457319
Onychomycosis 14.04 10.98 4 72990 38527 110477778
Acute abdomen 14.01 10.98 14 72980 3347 110512958
Secondary amyloidosis 13.82 10.98 6 72988 341 110515964
Acarodermatitis 13.74 10.98 11 72983 1970 110514335
Dysphoria 13.73 10.98 19 72975 6409 110509896
Vomiting 13.64 10.98 733 72261 909942 109606363
White blood cell count decreased 13.60 10.98 92 72902 229298 110287007
Allergic eosinophilia 13.57 10.98 4 72990 72 110516233
Strabismus 13.54 10.98 14 72980 3485 110512820
Muscle spasms 13.46 10.98 118 72876 278039 110238266
Spondyloarthropathy 13.46 10.98 10 72984 1604 110514701
Neuroleptic malignant syndrome 13.44 10.98 3 72991 34056 110482249
Intentional self-injury 13.43 10.98 4 72990 37425 110478880
Cytokine release syndrome 13.37 10.98 16 72978 70290 110446015
Coma 13.31 10.98 37 72957 117832 110398473
Thrombocytopenic purpura 13.30 10.98 13 72981 3026 110513279
Tendon rupture 13.30 10.98 29 72965 14049 110502256
Colitis ulcerative 13.29 10.98 19 72975 77344 110438961
Bone erosion 13.28 10.98 7 72987 46364 110469941
Therapy partial responder 13.23 10.98 54 72940 37007 110479298
Eosinophilic pneumonia acute 13.18 10.98 10 72984 1655 110514650
Dysarthria 13.17 10.98 22 72972 84099 110432206
Contusion 13.14 10.98 95 72899 233266 110283039
Axillary pain 13.11 10.98 12 72982 2574 110513731
Nausea 13.07 10.98 965 72029 1234725 109281580
Blood pressure systolic decreased 13.06 10.98 28 72966 13413 110502892
Pain 13.04 10.98 507 72487 954448 109561857
Chronic left ventricular failure 13.04 10.98 9 72985 1287 110515018
Vasoplegia syndrome 13.03 10.98 17 72977 5422 110510883
Disturbance in attention 13.02 10.98 13 72981 61982 110454323
Fixed eruption 13.01 10.98 15 72979 4217 110512088
Troponin I increased 13.00 10.98 17 72977 5435 110510870
Blood urea increased 12.96 10.98 71 72923 54886 110461419
Injection site pain 12.85 10.98 67 72927 177855 110338450
Carditis 12.78 10.98 5 72989 218 110516087
Cognitive disorder 12.69 10.98 24 72970 87487 110428818
Hepatosplenomegaly 12.66 10.98 19 72975 6900 110509405
Neurotoxicity 12.65 10.98 6 72988 42201 110474104
Penile discomfort 12.63 10.98 3 72991 22 110516283
Musculoskeletal pain 12.62 10.98 70 72924 182953 110333352
Contraindicated product administered 12.56 10.98 232 72762 248035 110268270
Pericardial fibrosis 12.46 10.98 5 72989 233 110516072
Lymphadenopathy 12.18 10.98 78 72916 63757 110452548
Influenza like illness 12.17 10.98 25 72969 88387 110427918
Sperm concentration decreased 12.11 10.98 4 72990 106 110516199
Pericarditis infective 12.11 10.98 5 72989 251 110516054
Disseminated coccidioidomycosis 12.11 10.98 5 72989 251 110516054
Sleep disorder due to a general medical condition 12.05 10.98 10 72984 52102 110464203
Palmar-plantar erythrodysaesthesia syndrome 12.04 10.98 6 72988 41019 110475286
Product prescribing issue 11.72 10.98 26 72968 12746 110503559
Enanthema 11.70 10.98 8 72986 1126 110515179
Bicytopenia 11.64 10.98 18 72976 6706 110509599
Thrombocytosis 11.61 10.98 23 72971 10421 110505884
Symptom recurrence 11.56 10.98 15 72979 4757 110511548
Insomnia 11.52 10.98 168 72826 360422 110155883
Psychotic disorder 11.50 10.98 10 72984 50927 110465378
Pleurisy 11.49 10.98 25 72969 12091 110504214
Haemorrhagic diathesis 11.49 10.98 19 72975 7489 110508816
Gastrointestinal haemorrhage 11.49 10.98 163 72831 165355 110350950
Maternal exposure during breast feeding 11.34 10.98 14 72980 4224 110512081
Metastases to spleen 11.27 10.98 7 72987 837 110515468
Osteomyelitis 11.27 10.98 51 72943 36549 110479756
Hepatic cirrhosis 11.23 10.98 17 72977 67609 110448696
Ear infection 11.18 10.98 15 72979 62717 110453588
Nasal crusting 11.15 10.98 7 72987 854 110515451
Troponin increased 11.13 10.98 44 72950 29722 110486583
Muscle atrophy 11.07 10.98 26 72968 13228 110503077

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC M04AC01 MUSCULO-SKELETAL SYSTEM
ANTIGOUT PREPARATIONS
ANTIGOUT PREPARATIONS
Preparations with no effect on uric acid metabolism
ATC M04AC51 MUSCULO-SKELETAL SYSTEM
ANTIGOUT PREPARATIONS
ANTIGOUT PREPARATIONS
Preparations with no effect on uric acid metabolism
FDA CS M0000713 Alkaloids
MeSH PA D006074 Gout Suppressants
MeSH PA D018501 Antirheumatic Agents
MeSH PA D050256 Antimitotic Agents
MeSH PA D050257 Tubulin Modulators
CHEBI has role CHEBI:61951 microtubule-destabilising agent
CHEBI has role CHEBI:76924 plant metabolite
FDA EPC N0000193949 Alkaloid

Related Drugs by ATC class:

M04AC Preparations with no effect on uric acid metabolism 2 drugs
cinchophenprobenecid

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

DiseaseRelationSNOMED_IDDOID
Familial Mediterranean fever indication 12579009 DOID:2987
Atherosclerosis indication 38716007 DOID:1936
Cardiovascular disease indication 49601007 DOID:1287
Chronic gouty arthritis indication 68451005
Gout indication 90560007 DOID:13189
Gout Prevention indication
Peptic ulcer contraindication 13200003 DOID:750
Acute nephropathy contraindication 58574008
Hepatic failure contraindication 59927004
Diarrhea contraindication 62315008
Leukopenia contraindication 84828003 DOID:615
Anemia due to enzyme deficiency contraindication 111577008
Disorder of muscle contraindication 129565002 DOID:423
Disease of blood AND/OR blood-forming organ contraindication 191124002 DOID:74
Impaired renal function disorder contraindication 197663003
Rhabdomyolysis contraindication 240131006
Renal dialysis contraindication 265764009
Uric acid renal calculus contraindication 274401005
Thrombocytopenic disorder contraindication 302215000 DOID:1588
Aplastic anemia contraindication 306058006 DOID:12449
Bone marrow depression contraindication 307762000
Granulocytopenic disorder contraindication 417672002
Vomiting contraindication 422400008
Uric Acid Nephropathy Gout contraindication




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 13.19 acidic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
0.6MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** COLCRYS TAKEDA PHARMS USA N022352 July 29, 2009 DISCN TABLET ORAL 7964647 Oct. 6, 2028 METHOD OF TREATING GOUT FLARES
0.6MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** COLCRYS TAKEDA PHARMS USA N022352 July 29, 2009 DISCN TABLET ORAL 7964648 Oct. 6, 2028 FOR THE TREATMENT AND PROPHYLAXIS OF GOUT FLARES & THE TREATMENT OF FAMILIAL MEDITERRANEAN FEVER
0.6MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** COLCRYS TAKEDA PHARMS USA N022352 July 29, 2009 DISCN TABLET ORAL 7981938 Oct. 6, 2028 A METHOD FOR TREATMENT OF GOUT FLARES DURING PROPHYLAXIS
0.6MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** COLCRYS TAKEDA PHARMS USA N022352 July 29, 2009 DISCN TABLET ORAL 8093296 Oct. 6, 2028 METHOD OF TREATING GOUT FLARES
0.6MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** COLCRYS TAKEDA PHARMS USA N022352 July 29, 2009 DISCN TABLET ORAL 8093297 Oct. 6, 2028 FOR THE TREATMENT AND PROPHYLAXIS OF GOUT FLARES & THE TREATMENT OF FAMILIAL MEDITERRANEAN FEVER
0.6MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** COLCRYS TAKEDA PHARMS USA N022352 July 29, 2009 DISCN TABLET ORAL 8093298 Oct. 6, 2028 METHOD OF ADMINISTERING COLCHICINE TO FAMILIAL MEDITERRANEAN FEVER PATIENTS
0.6MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** COLCRYS TAKEDA PHARMS USA N022352 July 29, 2009 DISCN TABLET ORAL 8097655 Oct. 6, 2028 METHOD OF USING COLCHICINE FOR THE PROPHYLAXIS OF GOUT FLARES
0.6MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** COLCRYS TAKEDA PHARMS USA N022352 July 29, 2009 DISCN TABLET ORAL 8415395 Oct. 6, 2028 METHOD OF TREATING GOUT FLARES
0.6MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** COLCRYS TAKEDA PHARMS USA N022352 July 29, 2009 DISCN TABLET ORAL 8415396 Oct. 6, 2028 METHOD OF TREATING GOUT FLARES
0.6MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** COLCRYS TAKEDA PHARMS USA N022352 July 29, 2009 DISCN TABLET ORAL 7619004 Dec. 3, 2028 METHOD OF USING COLCHICINE FOR THE PROPHYLAXIS OF GOUT FLARES
0.6MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** COLCRYS TAKEDA PHARMS USA N022352 July 29, 2009 DISCN TABLET ORAL 7935731 Dec. 3, 2028 METHOD OF ADMINISTERING COLCHICINE TO FAMILIAL MEDITERRANEAN FEVER PATIENTS
0.6MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** COLCRYS TAKEDA PHARMS USA N022352 July 29, 2009 DISCN TABLET ORAL 7601758 Feb. 10, 2029 METHOD OF TREATING GOUT FLARES
0.6MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** COLCRYS TAKEDA PHARMS USA N022352 July 29, 2009 DISCN TABLET ORAL 7820681 Feb. 17, 2029 METHOD OF USING COLCHICINE FOR THE PROPHYLAXIS OF GOUT FLARES
0.6MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** COLCRYS TAKEDA PHARMS USA N022352 July 29, 2009 DISCN TABLET ORAL 7906519 Feb. 17, 2029 METHOD OF ADMINISTERING COLCHICINE TO FAMILIAL MEDITERRANEAN FEVER PATIENTS
0.6MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** COLCRYS TAKEDA PHARMS USA N022352 July 29, 2009 DISCN TABLET ORAL 7915269 Feb. 17, 2029 METHOD OF TREATING GOUT FLARES
0.6MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** COLCRYS TAKEDA PHARMS USA N022352 July 29, 2009 DISCN TABLET ORAL 8440721 Feb. 17, 2029 METHOD OF TREATING GOUT FLARES
0.6MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** COLCRYS TAKEDA PHARMS USA N022352 July 29, 2009 DISCN TABLET ORAL 8440722 Feb. 17, 2029 METHOD OF USING COLCHICINE FOR THE PROPHYLAXIS OF GOUT FLARES
0.6MG MITIGARE HIKMA INTL PHARMS N204820 Sept. 26, 2014 RX CAPSULE ORAL 8927607 Aug. 22, 2033 METHOD OF USING COLCHICINE FOR THE PROPHYLAXIS OF GOUT FLARES
0.6MG MITIGARE HIKMA INTL PHARMS N204820 Sept. 26, 2014 RX CAPSULE ORAL 9399036 Aug. 22, 2033 METHOD OF USING COLCHICINE FOR THE PROPHYLAXIS OF GOUT FLARES
0.6MG MITIGARE HIKMA INTL PHARMS N204820 Sept. 26, 2014 RX CAPSULE ORAL 9555029 Aug. 22, 2033 METHOD OF USING COLCHICINE FOR THE PROPHYLAXIS OF GOUT FLARES
0.6MG MITIGARE HIKMA INTL PHARMS N204820 Sept. 26, 2014 RX CAPSULE ORAL 9675613 Aug. 22, 2033 METHOD OF USING COLCHICINE FOR THE PROPHYLAXIS OF GOUT FLARES
0.6MG MITIGARE HIKMA INTL PHARMS N204820 Sept. 26, 2014 RX CAPSULE ORAL 9789108 Aug. 22, 2033 METHOD OF USING COLCHICINE FOR THE PROPHYLAXIS OF GOUT FLARES
0.5MG LODOCO AGEPHA PHARMA FZ N215727 June 16, 2023 RX TABLET ORAL 10206891 Nov. 1, 2033 A METHOD OF TREATING AND/OR REDUCING THE RISK OF A CARDIOVASCULAR EVENT; ACUTE CORONARY SYNDROME, OUT-OF-HOSPITAL CARDIAC ARREST, AND/OR NONCARDIOEMBOLIC ISCHEMIC STROKE
0.5MG LODOCO AGEPHA PHARMA FZ N215727 June 16, 2023 RX TABLET ORAL 10265281 Nov. 1, 2033 A METHOD FOR TREATING AND/OR REDUCING THE RISK OF A CARDIOVASCULAR EVENT
0.5MG LODOCO AGEPHA PHARMA FZ N215727 June 16, 2023 RX TABLET ORAL 10842762 Nov. 1, 2033 A METHOD OF TREATING AND/OR REDUCING THE RISK OF INFLAMMATION, ATHEROSCLEROTIC VASCULAR DISEASE, AND CHOLESTEROL CRYSTAL INDUCED INFLAMMATION WITHIN ATHEROSCLEROTIC PLAQUES
0.5MG LODOCO AGEPHA PHARMA FZ N215727 June 16, 2023 RX TABLET ORAL 11026899 Nov. 1, 2033 A METHOD FOR TREATING AND/OR REDUCING THE RISK OF A CARDIOVASCULAR EVENT
0.5MG LODOCO AGEPHA PHARMA FZ N215727 June 16, 2023 RX TABLET ORAL 11026900 Nov. 1, 2033 A METHOD FOR TREATING AND/OR REDUCING THE RISK OF A CARDIOVASCULAR EVENT
0.5MG LODOCO AGEPHA PHARMA FZ N215727 June 16, 2023 RX TABLET ORAL 11026901 Nov. 1, 2033 A METHOD FOR TREATING AND/OR REDUCING THE RISK OF ACUTE MYOCARDIAL INFARCTION
0.5MG LODOCO AGEPHA PHARMA FZ N215727 June 16, 2023 RX TABLET ORAL 11944594 Nov. 1, 2033 METHOD FOR REDUCING A RISK OF AT LEAST ONE CARDIOVASCULAR EVENT
0.5MG LODOCO AGEPHA PHARMA FZ N215727 June 16, 2023 RX TABLET ORAL 11944595 Nov. 1, 2033 METHOD FOR REDUCING A COMPOSITE ENDPOINT RISK OF MYOCARDIAL INFARCTION (MI), STROKE, CORONARY REVASCULARIZATION, UNSTABLE ANGINA REQUIRING HOSPITALIZATION, CARDIAC ARREST, AND CARDIOVASCULAR DEATH
0.5MG LODOCO AGEPHA PHARMA FZ N215727 June 16, 2023 RX TABLET ORAL 11944595 Nov. 1, 2033 METHOD FOR REDUCING ACUTE MYOCARDIAL INFARCTION RISK
0.5MG LODOCO AGEPHA PHARMA FZ N215727 June 16, 2023 RX TABLET ORAL 12233035 Nov. 1, 2033 A METHOD OF TREATING AND/OR REDUCING THE RISK OF A CARDIOVASCULAR EVENT IN A PATIENT
0.5MG LODOCO AGEPHA PHARMA FZ N215727 June 16, 2023 RX TABLET ORAL 12280025 Nov. 1, 2033 A METHOD FOR REDUCING A RISK OF AT LEAST ONE CARDIOVASCULAR EVENT
0.5MG LODOCO AGEPHA PHARMA FZ N215727 June 16, 2023 RX TABLET ORAL 12364675 Nov. 1, 2033 A METHOD FOR TREATING AND/OR REDUCING THE RISK OF A CARDIOVASCULAR EVENT
0.5MG LODOCO AGEPHA PHARMA FZ N215727 June 16, 2023 RX TABLET ORAL 9744144 Nov. 1, 2033 METHOD OF TREATING AND/OR REDUCING THE RISK OF A CARDIOVASCULAR EVENT
0.5MG LODOCO AGEPHA PHARMA FZ N215727 June 16, 2023 RX TABLET ORAL 10130585 May 9, 2034 A METHOD OF TREATING CARDIOVASCULAR DISEASE
0.6MG/5ML GLOPERBA SCILEX PHARMS N210942 Jan. 30, 2019 RX SOLUTION ORAL 10383820 Nov. 22, 2036 A METHOD OF PROPHYLACTIC TREATMENT OF GOUT FLARES IN ADULTS COMPRISES ADMINISTERING TO A PATIENT A LIQUID COLCHICINE ORAL SOLUTION
0.6MG/5ML GLOPERBA SCILEX PHARMS N210942 Jan. 30, 2019 RX SOLUTION ORAL 12274751 Nov. 22, 2036 A METHOD OF PROPHYLACTIC TREATMENT OF GOUT FLARES IN ADULTS COMPRISES ADMINISTERING TO A PATIENT A LIQUID COLCHICINE ORAL SOLUTION
0.6MG/5ML GLOPERBA SCILEX PHARMS N210942 Jan. 30, 2019 RX SOLUTION ORAL 12514819 Nov. 22, 2036 A METHOD OF PROPHYLACTIC TREATMENT OF GOUT FLARES IN ADULTS COMPRISES ADMINISTERING TO A PATIENT A LIQUID COLCHICINE ORAL SOLUTION

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])		Mechanism
action		Bioact sourceMoA source
Cytochrome P450 3A4 Enzyme Ki 4.19 WOMBAT-PK
Multidrug resistance protein 1 Transporter Kd 3.80 WOMBAT-PK
Multidrug resistance-associated protein 1 Transporter WOMBAT-PK
Glycine receptor subunit alpha-1 Ion channel IC50 3.49 WOMBAT-PK
Glycine receptor subunit alpha-2 Ion channel IC50 4.19 WOMBAT-PK
Tubulin beta chain Structural INHIBITOR Ki 5.24 WOMBAT-PK
Serine/threonine-protein kinase pim-1 Kinase IC50 5.37 CHEMBL
Bromodomain-containing protein 4 Nuclear other INHIBITOR Kd 4.70 IUPHAR
Tubulin beta-4B chain Structural Ki 5.24 WOMBAT-PK
Tubulin alpha-1A chain Structural Ki 5.60 CHEMBL
Tubulin beta-2B chain Structural Ki 6.11 CHEMBL
Tubulin polymerization-promoting protein Cytosolic other EC50 6.12 CHEMBL
Tubulin Structural IC50 6.10 CHEMBL
Tubulin Structural Ki 5.24 CHEMBL

External reference:

IDSource
4020930 VUID
N0000148412 NUI
D00570 KEGG_DRUG
2683 RXNORM
C0009262 UMLSCUI
CHEBI:27882 CHEBI
LOC PDB_CHEM_ID
CHEMBL107 ChEMBL_ID
D003078 MESH_DESCRIPTOR_UI
DB01394 DRUGBANK_ID
6167 PUBCHEM_CID
2367 IUPHAR_LIGAND_ID
SML2Y3J35T UNII
4493 MMSL
581 MMSL
d00150 MMSL
002372 NDDF
387413002 SNOMEDCT_US
73133000 SNOMEDCT_US
4017416 VANDF
4020930 VANDF

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Colchicine HUMAN PRESCRIPTION DRUG LABEL 1 0143-3018 CAPSULE 0.60 mg ORAL NDA 29 sections
Colchicine HUMAN PRESCRIPTION DRUG LABEL 1 0254-0460 CAPSULE 0.60 mg ORAL ANDA 27 sections
Colchicine HUMAN PRESCRIPTION DRUG LABEL 1 0254-2008 TABLET, FILM COATED 0.60 mg ORAL NDA AUTHORIZED GENERIC 32 sections
Colchicine HUMAN PRESCRIPTION DRUG LABEL 1 0378-1086 TABLET, FILM COATED 0.60 mg ORAL ANDA 28 sections
Probenecid and Colchicine HUMAN PRESCRIPTION DRUG LABEL 2 0591-5325 TABLET 0.50 mg ORAL ANDA 13 sections
Colchicine HUMAN PRESCRIPTION DRUG LABEL 1 0904-6732 CAPSULE 0.60 mg ORAL NDA 29 sections
Colchicine HUMAN PRESCRIPTION DRUG LABEL 1 0904-7120 TABLET, FILM COATED 0.60 mg ORAL ANDA 27 sections
Colcrys HUMAN PRESCRIPTION DRUG LABEL 1 13310-119 TABLET, FILM COATED 0.60 mg ORAL NDA 29 sections
Probenecid and Colchicine Human Prescription Drug Label 2 16571-832 TABLET 0.50 mg ORAL ANDA 12 sections
Colchicine HUMAN PRESCRIPTION DRUG LABEL 1 23155-855 TABLET, FILM COATED 0.60 mg ORAL ANDA 23 sections
COLCHICINE HUMAN PRESCRIPTION DRUG LABEL 1 31722-099 CAPSULE 0.60 mg ORAL ANDA 26 sections
Colchicine HUMAN PRESCRIPTION DRUG LABEL 1 31722-899 TABLET, FILM COATED 0.60 mg ORAL ANDA 26 sections
Colchicine Human Prescription Drug Label 1 33342-341 TABLET 0.60 mg ORAL ANDA 26 sections
Colchicine HUMAN PRESCRIPTION DRUG LABEL 1 42571-341 CAPSULE 0.60 mg ORAL ANDA 26 sections
Colcrys HUMAN PRESCRIPTION DRUG LABEL 1 43353-854 TABLET, FILM COATED 0.60 mg ORAL NDA 28 sections
colchicine HUMAN PRESCRIPTION DRUG LABEL 1 43598-372 TABLET 0.60 mg ORAL ANDA 28 sections
Colchicine HUMAN PRESCRIPTION DRUG LABEL 1 49884-171 TABLET, FILM COATED 0.60 mg ORAL ANDA 27 sections
Colchicine HUMAN PRESCRIPTION DRUG LABEL 1 50090-3465 CAPSULE 0.60 mg ORAL NDA 29 sections
colchicine Human Prescription Drug Label 1 50090-8014 TABLET 0.60 mg ORAL ANDA 27 sections
Colchicine HUMAN PRESCRIPTION DRUG LABEL 1 50268-187 TABLET 0.60 mg ORAL ANDA 19 sections
Probenecid and Colchicine Human Prescription Drug Label 2 50742-263 TABLET 0.50 mg ORAL ANDA 13 sections
Colchicine HUMAN PRESCRIPTION DRUG LABEL 1 51407-082 TABLET, FILM COATED 0.60 mg ORAL ANDA 27 sections
Colcrys HUMAN PRESCRIPTION DRUG LABEL 1 54868-6256 TABLET, FILM COATED 0.60 mg ORAL NDA 29 sections
MITIGARE HUMAN PRESCRIPTION DRUG LABEL 1 59467-318 CAPSULE 0.60 mg ORAL NDA 30 sections
Colchicine Human Prescription Drug Label 1 59651-446 CAPSULE 0.60 mg ORAL ANDA 27 sections
Colchicine Human Prescription Drug Label 1 59651-455 TABLET 0.60 mg ORAL ANDA 27 sections
Colchicine HUMAN PRESCRIPTION DRUG LABEL 1 60687-358 CAPSULE 0.60 mg ORAL NDA 27 sections
Colchicine HUMAN PRESCRIPTION DRUG LABEL 1 60687-727 TABLET, FILM COATED 0.60 mg ORAL ANDA 27 sections
colchicine HUMAN PRESCRIPTION DRUG LABEL 1 60760-839 TABLET 0.60 mg ORAL ANDA 27 sections
Colchicine HUMAN PRESCRIPTION DRUG LABEL 1 62135-789 TABLET, FILM COATED 0.60 mg ORAL ANDA 19 sections