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

Stem definitionDrug idCAS RN
sodium glucose co-transporter inhibitors, phlorizin derivatives 4304 461432-26-8

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • dapagliflozin propanediol monohydrate
  • dapagliflozin propanediol
  • BMS 512148
  • forxiga
  • dapaglifozin
  • dapagliflozin
  • farxiga
  • dapagliflozin propylene glycolate hydrate
an Sodium-glucose cotransporter 2 (SGLT2) inhibitor, SGLT2 expressed in the proximal renal tubules, is responsible for the majority of the reabsorption of filtered glucose from the tubular lumen, by inhibiting SGLT2, dapagliflozin reduces reabsorption of filtered glucose and lowers the renal threshold for glucose, and thereby increases urinary glucose excretion
  • Molecular weight: 408.88
  • Formula: C21H25ClO6
  • CLOGP: 3.37
  • LIPINSKI: 0
  • HAC: 6
  • HDO: 4
  • TPSA: 99.38
  • ALOGS: -3.37
  • ROTB: 6
  • Status: OFP
    • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
10 mg O

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 1 Hosey CM, Chan R, Benet LZ
Vd (Volume of distribution) 1.70 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 3 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.09 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 12.20 hours Lombardo F, Berellini G, Obach RS
S (Water solubility) 1.60 mg/mL Bocci G, Oprea TI, Benet LZ
BA (Bioavailability) 78 %

Predicted pharmacokinetic/toxicological properties (PK-AZ):

PropertyDescriptionValueUnitConfidenceSimilarity
azlogd74 LogD at pH 7.4 2.121 High 0.82
caco2-efflux Caco-2 efflux ratio (BA/AB) 5.508 High 0.82
caco2-intrinsic-papp Caco-2 intrinsic apparent permeability 19.543 10^-6 cm/s High 0.82
dh-clint Dog hepatocyte intrinsic clearance 3.707 uL/min/10^6 cells High 0.82
dppb Dog plasma protein binding (% unbound) 8.920 % High 0.82
fcs-ppb Fetal calf serum protein binding (% unbound) 15.970 % High 0.82
herg hERG pIC50 4.496 pIC50 High 0.82
hh-clint Human hepatocyte intrinsic clearance 2.924 uL/min/10^6 cells High 0.82
hlm-clint Human liver microsomal intrinsic clearance 3.055 uL/min/mg protein High 0.82
hppb Human plasma protein binding (% unbound) 9.560 % High 0.82
kinase-safety-class ACVR2B,BRAF,BTK,CAMK2D,CDK5,EIF2AK3,ERBB2,GRK2,ITK,MAP2K6,MAPK10,MAPK7,NTRK2,PDK1,PDK2,PDK4,PRKDC,TEK,TGFBR1,ZAP70 20
kinase-selectivity-class AXL,GRK2,MAP2K6 3
mdck-mdr1-bcrp-efflux MDCK-MDR1-BCRP efflux ratio 15.417 High 1
mdck-mdr1-efflux MDCK-MDR1 efflux ratio 11.508 High 0.82
mh-clint Mouse hepatocyte intrinsic clearance 14.555 High 0.82
mppb Mouse plasma protein binding (% unbound) 9.540 High 0.82
nih-mdck-mdr1-efflux NIH MDCK-MDR1 efflux ratio 29.444 High 0.82
pfas-class PFAS structural alert (1 = True, 0 = False) 0
pppb Pig plasma protein binding (% unbound) 12.780 % High 0.82
rat-kpuu-brain Rat brain Kpuu 0.026 % High 1
rh-clint Rat hepatocyte intrinsic clearance 8.590 uL/min/10^6 cells High 0.82
rh-fuinc Rat hepatocyte fraction unbound in incubation 69.660 % High 0.82
rppb Rat plasma protein binding (% unbound) 5.950 % High 0.82
solubility-dd Solubility at pH 7.4 in DMSO 785.236 uM High 0.82

Approvals:

DateAgencyCompanyOrphan
March 24, 2014 PMDA BRISTOL-MYERS
Jan. 8, 2014 FDA ASTRAZENECA AB
Nov. 12, 2012 EMA

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
Diabetic ketoacidosis 3101.26 14.84 902 39600 23505 90564440
Ketoacidosis 1503.13 14.84 374 40128 5221 90582724
Euglycaemic diabetic ketoacidosis 1189.45 14.84 317 40185 5884 90582061
Death 496.01 14.84 796 39706 455755 90132190
Acute kidney injury 484.32 14.84 653 39849 319734 90268211
Pruritus genital 412.53 14.84 130 40372 4428 90583517
Fungal infection 407.97 14.84 248 40254 42413 90545532
Ketosis 407.01 14.84 90 40412 719 90587226
Cardiospasm 285.92 14.84 92 40410 3354 90584591
Palmoplantar keratoderma 284.33 14.84 92 40410 3415 90584530
Lactic acidosis 281.56 14.84 210 40292 50253 90537692
Glomerular filtration rate decreased 258.89 14.84 134 40368 16798 90571147
Sleep terror 251.11 14.84 89 40413 4375 90583570
Dehydration 251.03 14.84 368 40134 194079 90393866
Glycosylated haemoglobin increased 240.35 14.84 124 40378 15438 90572507
Carotid artery occlusion 238.08 14.84 94 40408 6248 90581697
Blood glucose increased 237.48 14.84 251 40251 94995 90492950
Atrial tachycardia 229.13 14.84 90 40412 5900 90582045
Cardiac failure 223.74 14.84 260 40242 109236 90478709
Diabetes mellitus inadequate control 221.78 14.84 125 40377 18559 90569386
Metabolic acidosis 215.38 14.84 187 40315 55489 90532456
Tension headache 209.47 14.84 90 40412 7419 90580526
Hypoglycaemia 206.78 14.84 202 40300 69646 90518299
Blood ketone body increased 197.36 14.84 43 40459 318 90587627
Urinary tract infection 195.05 14.84 425 40077 305207 90282738
Hyperkalaemia 192.53 14.84 188 40314 64776 90523169
Immunisation 191.47 14.84 61 40441 2152 90585793
Diabetic ketosis 188.83 14.84 45 40457 516 90587429
Anosmia 186.11 14.84 90 40412 9758 90578187
Urine ketone body present 182.93 14.84 61 40441 2491 90585454
Vasculitis 181.86 14.84 118 40384 22575 90565370
Vulvovaginal pruritus 174.13 14.84 66 40436 3927 90584018
Facial pain 164.09 14.84 91 40411 13091 90574854
Renal impairment 161.91 14.84 217 40285 105204 90482741
Ventricular tachycardia 160.97 14.84 113 40389 24595 90563350
Subarachnoid haemorrhage 155.63 14.84 98 40404 17806 90570139
Infusion related reaction 153.47 14.84 8 40494 416772 90171173
Pain of skin 152.39 14.84 93 40409 15989 90571956
Ketonuria 140.59 14.84 38 40464 743 90587202
Necrotising fasciitis 133.45 14.84 54 40448 3826 90584119
Pemphigus 131.67 14.84 3 40499 326861 90261084
Hypoglycaemic coma 128.86 14.84 49 40453 2941 90585004
Drug ineffective 124.64 14.84 272 40230 1384026 89203919
Tinnitus 122.59 14.84 122 40380 42980 90544965
Blindness 120.81 14.84 98 40404 26470 90561475
Lip swelling 120.51 14.84 115 40387 38495 90549450
Muscle twitching 120.16 14.84 94 40408 24108 90563837
Joint swelling 119.79 14.84 38 40464 503262 90084683
Palpitations 115.62 14.84 214 40288 136514 90451431
Treatment failure 114.53 14.84 5 40497 303923 90284022
Arthropathy 113.10 14.84 15 40487 366227 90221718
Wound 110.91 14.84 6 40496 302974 90284971
Eye pruritus 109.21 14.84 96 40406 28931 90559014
Diplopia 108.10 14.84 95 40407 28619 90559326
Glucose urine present 107.63 14.84 32 40470 892 90587053
Diabetic metabolic decompensation 106.21 14.84 38 40464 1919 90586026
COVID-19 98.76 14.84 227 40275 168616 90419329
Genital infection 94.38 14.84 21 40481 173 90587772
Transient ischaemic attack 93.97 14.84 106 40396 43070 90544875
Marasmus 93.69 14.84 28 40474 795 90587150
Therapeutic product effect decreased 91.60 14.84 9 40493 277562 90310383
Maternal exposure during pregnancy 91.48 14.84 24 40478 360039 90227906
Pollakiuria 91.23 14.84 92 40410 32913 90555032
Angioedema 91.19 14.84 128 40374 64748 90523197
Hypersensitivity 90.67 14.84 45 40457 454632 90133313
Sinusitis 86.90 14.84 23 40479 343065 90244880
Musculoskeletal stiffness 85.01 14.84 15 40487 296517 90291428
Swelling 82.75 14.84 42 40460 419016 90168929
Nasopharyngitis 80.09 14.84 41 40461 407063 90180882
Hepatic enzyme increased 79.31 14.84 31 40471 360705 90227240
Disturbance in attention 78.51 14.84 101 40401 47008 90540937
Urosepsis 77.43 14.84 69 40433 21163 90566782
Impaired healing 76.21 14.84 8 40494 234191 90353754
Dry skin 74.60 14.84 138 40364 87935 90500010
Psoriatic arthropathy 73.79 14.84 8 40494 228327 90359618
Hallucination 72.49 14.84 116 40386 65843 90522102
Stomatitis 72.29 14.84 17 40485 274681 90313264
Injury 71.91 14.84 4 40498 197345 90390600
Drug intolerance 71.72 14.84 57 40445 447534 90140411
Irritable bowel syndrome 70.38 14.84 6 40496 207442 90380503
Rash papular 70.00 14.84 64 40438 20291 90567654
Rheumatoid arthritis 69.13 14.84 38 40464 362576 90225369
Lower respiratory tract infection 69.02 14.84 14 40488 250645 90337300
Polyuria 67.91 14.84 47 40455 9993 90577952
Drug hypersensitivity 67.09 14.84 65 40437 463544 90124401
Myocardial infarction 66.99 14.84 147 40355 105825 90482120
Fibromyalgia 64.72 14.84 8 40494 206261 90381684
Systemic lupus erythematosus 64.65 14.84 41 40461 361855 90226090
Hyperglycaemia 62.08 14.84 94 40408 50876 90537069
Drug interaction 61.79 14.84 266 40236 276187 90311758
Candida infection 61.48 14.84 76 40426 33981 90553964
Weight decreased 61.43 14.84 333 40169 379577 90208368
Cognitive disorder 60.35 14.84 110 40392 69297 90518648
Dizziness 59.27 14.84 458 40044 588826 89999119
Contraindicated product administered 58.94 14.84 35 40467 320104 90267841
Genital infection female 58.76 14.84 13 40489 104 90587841
Dysuria 58.75 14.84 80 40422 39321 90548624
Wheezing 58.32 14.84 17 40485 238063 90349882
Pyelonephritis 58.14 14.84 59 40443 21257 90566688
Exposure during pregnancy 56.64 14.84 18 40484 238392 90349553
Acidosis 55.84 14.84 46 40456 12690 90575255
Cardiac failure chronic 54.38 14.84 33 40469 5613 90582332
Hypernatraemia 52.17 14.84 39 40463 9348 90578597
Chronic kidney disease 52.06 14.84 86 40416 50105 90537840
Glomerular filtration rate increased 51.95 14.84 23 40479 2037 90585908
Hyperhidrosis 50.79 14.84 155 40347 136150 90451795
Catarrh 50.27 14.84 21 40481 1613 90586332
Musculoskeletal toxicity 50.06 14.84 16 40486 570 90587375
Chest wall mass 49.28 14.84 16 40486 600 90587345
Cerebral infarction 49.05 14.84 60 40442 26536 90561409
Dermo-hypodermitis 48.87 14.84 17 40485 790 90587155
Scan abnormal 48.75 14.84 16 40486 621 90587324
Intentional product misuse 48.56 14.84 117 40385 89487 90498458
Pneumonia 48.00 14.84 137 40365 637922 89950023
Blister 46.75 14.84 28 40474 254970 90332975
Burns second degree 46.39 14.84 21 40481 1959 90585986
Blood creatinine increased 46.23 14.84 124 40378 101262 90486683
Blood ketone body 46.13 14.84 10 40492 72 90587873
Blood cholesterol increased 45.48 14.84 18 40484 207994 90379951
Contusion 45.47 14.84 28 40474 251188 90336757
Renal failure 45.14 14.84 145 40357 130862 90457083
Temperature perception test abnormal 44.60 14.84 8 40494 17 90587928
Left ventricular dysfunction 44.45 14.84 43 40459 14626 90573319
Discomfort 43.82 14.84 35 40467 274300 90313645
Steroid dependence 43.66 14.84 21 40481 2248 90585697
Heart rate increased 43.57 14.84 130 40372 112772 90475173
Hyperglycaemic hyperosmolar nonketotic syndrome 43.49 14.84 18 40484 1351 90586594
Gait inability 42.85 14.84 7 40495 146449 90441496
Vulvovaginitis 42.84 14.84 13 40489 389 90587556
Musculoskeletal pain 42.35 14.84 12 40490 171239 90416706
Urine albumin/creatinine ratio abnormal 41.93 14.84 10 40492 115 90587830
Vulvovaginal candidiasis 40.69 14.84 24 40478 3876 90584069
Leukocyturia 40.55 14.84 18 40484 1604 90586341
Ill-defined disorder 40.42 14.84 16 40486 184875 90403070
Blood alkaline phosphatase abnormal 40.14 14.84 17 40485 1351 90586594
Blood albumin abnormal 39.54 14.84 16 40486 1133 90586812
Blood creatinine abnormal 39.27 14.84 24 40478 4133 90583812
Ischaemic stroke 39.26 14.84 49 40453 22117 90565828
Hypoaesthesia 38.89 14.84 50 40452 314160 90273785
Pancreatitis acute 38.78 14.84 59 40443 32056 90555889
Polycythaemia 38.58 14.84 16 40486 1207 90586738
Microalbuminuria 38.49 14.84 13 40489 552 90587393
Night sweats 38.01 14.84 6 40496 128760 90459185
Atrial fibrillation 37.40 14.84 138 40364 133473 90454472
Trisomy 21 37.06 14.84 12 40490 446 90587499
Blood glucose abnormal 36.91 14.84 32 40470 9460 90578485
Liver injury 36.89 14.84 15 40487 170552 90417393
Therapy non-responder 36.86 14.84 8 40494 136696 90451249
Pulmonary fibrosis 36.75 14.84 3 40499 107500 90480445
Acetonaemia 36.52 14.84 11 40491 321 90587624
Genital infection fungal 36.19 14.84 10 40492 213 90587732
Lung disorder 36.15 14.84 11 40491 149872 90438073
Glycosuria 36.04 14.84 16 40486 1426 90586519
Urogenital infection fungal 35.55 14.84 7 40495 29 90587916
Hypopnoea 35.39 14.84 23 40479 4408 90583537
Inflammation 35.05 14.84 18 40484 178574 90409371
Blood ketone body present 35.03 14.84 8 40494 75 90587870
Urinary tract infection fungal 34.86 14.84 13 40489 739 90587206
Vomiting 34.72 14.84 519 39983 787774 89800171
Blood bilirubin abnormal 34.26 14.84 17 40485 1947 90585998
Nephrotic syndrome 33.20 14.84 27 40475 7312 90580633
Perineal infection 32.83 14.84 9 40493 186 90587759
Hypotension 32.67 14.84 253 40249 325144 90262801
Thirst 32.08 14.84 38 40464 16257 90571688
Vulvovaginal discomfort 31.87 14.84 18 40484 2679 90585266
Peripartum cardiomyopathy 31.83 14.84 9 40493 209 90587736
Sciatica 31.62 14.84 4 40498 101378 90486567
Lip dry 31.45 14.84 4 40498 100951 90486994
Blood calcium abnormal 31.23 14.84 16 40486 1961 90585984
Disease risk factor 30.94 14.84 9 40493 232 90587713
Glomerular filtration rate abnormal 30.68 14.84 14 40488 1331 90586614
Vulvovaginal mycotic infection 30.20 14.84 24 40478 6290 90581655
Vulvovaginal pain 30.14 14.84 19 40483 3455 90584490
Visual impairment 30.01 14.84 128 40374 132237 90455708
Osteoarthritis 29.98 14.84 26 40476 195704 90392241
Genital swelling 29.91 14.84 8 40494 150 90587795
Glycosylated haemoglobin abnormal 29.90 14.84 9 40493 262 90587683
Tubulointerstitial nephritis 29.81 14.84 46 40456 25297 90562648
Lupus nephritis 28.93 14.84 21 40481 4811 90583134
Pain 28.27 14.84 297 40205 996044 89591901
Emphysematous cystitis 28.23 14.84 9 40493 318 90587627
Feeling abnormal 27.92 14.84 148 40354 167087 90420858
C-reactive protein abnormal 27.89 14.84 11 40491 127418 90460527
Rhabdomyolysis 27.84 14.84 67 40435 51189 90536756
Pancreatitis 27.50 14.84 81 40421 69745 90518200
Urticaria 27.44 14.84 62 40440 312672 90275273
Prerenal failure 27.41 14.84 15 40487 2100 90585845
Burning feet syndrome 26.82 14.84 7 40495 119 90587826
Pyelonephritis acute 26.74 14.84 21 40481 5411 90582534
Perineal pain 26.74 14.84 10 40492 573 90587372
Vulvovaginal erythema 26.54 14.84 10 40492 585 90587360
Bladder trabeculation 26.49 14.84 6 40496 54 90587891
Condition aggravated 26.43 14.84 157 40345 595388 89992557
Infection 26.26 14.84 79 40423 362015 90225930
Blood urea increased 26.17 14.84 48 40454 30365 90557580
Therapeutic product effect incomplete 25.95 14.84 29 40473 193867 90394078
Adverse event 25.92 14.84 10 40492 117408 90470537
Mitral valve incompetence 25.27 14.84 40 40462 22484 90565461
Drug-disease interaction 25.23 14.84 11 40491 939 90587006
N-terminal prohormone brain natriuretic peptide increased 25.20 14.84 16 40486 2946 90584999
Haematuria 25.00 14.84 51 40451 34886 90553059
Altered state of consciousness 24.94 14.84 48 40454 31484 90556461
Crush syndrome 24.61 14.84 8 40494 301 90587644
Creatinine urine decreased 24.59 14.84 8 40494 302 90587643
Peripheral venous disease 24.57 14.84 4 40498 83917 90504028
Joint stiffness 24.53 14.84 3 40499 78039 90509906
Urinary occult blood positive 24.41 14.84 6 40496 79 90587866
Hypertensive heart disease 24.32 14.84 15 40487 2625 90585320
Sleep disorder 23.99 14.84 32 40470 197998 90389947
Sarcopenia 23.79 14.84 8 40494 335 90587610
Disease progression 23.74 14.84 21 40481 156594 90431351
Micturition urgency 23.45 14.84 27 40475 11206 90576739
C-reactive protein increased 23.33 14.84 28 40474 181361 90406584
Decreased vibratory sense 23.31 14.84 8 40494 357 90587588
Tachycardia 23.29 14.84 135 40367 157538 90430407
Vulvitis 22.89 14.84 8 40494 377 90587568
Neutrophil count abnormal 22.60 14.84 17 40485 4111 90583834
Alanine aminotransferase abnormal 22.54 14.84 19 40483 5407 90582538
Arteriosclerosis 22.51 14.84 26 40476 10827 90577118
Aortic valve calcification 22.41 14.84 9 40493 625 90587320
Toe amputation 22.29 14.84 13 40489 2056 90585889
Alkalosis hypochloraemic 22.24 14.84 7 40495 237 90587708
Genital rash 22.15 14.84 9 40493 644 90587301
Proteinuria 21.63 14.84 38 40464 23253 90564692
Diabetes mellitus 21.61 14.84 71 40431 64804 90523141
Diabetic retinopathy 21.52 14.84 14 40488 2688 90585257
Atrioventricular block complete 21.19 14.84 24 40478 9787 90578158
Amnesia 20.90 14.84 100 40402 108405 90479540
White blood cell count abnormal 20.88 14.84 21 40481 7483 90580462
Paraesthesia 20.86 14.84 51 40451 250275 90337670
Febrile neutropenia 20.84 14.84 24 40478 158325 90429620
Pancreatic carcinoma 20.71 14.84 22 40480 8355 90579590
General physical health deterioration 20.70 14.84 85 40417 355030 90232915
Orthopnoea 20.64 14.84 20 40482 6815 90581130
Vaginal infection 20.57 14.84 22 40480 8418 90579527
Nausea 20.38 14.84 644 39858 1109672 89478273
Diabetic ketoacidotic hyperglycaemic coma 20.19 14.84 5 40497 68 90587877
Mobility decreased 20.18 14.84 52 40450 250682 90337263
Funguria 20.14 14.84 3 40499 0 90587945
Parosmia 20.07 14.84 20 40482 7049 90580896
Polydipsia 20.06 14.84 16 40486 4215 90583730
Hypercholesterolaemia 20.04 14.84 10 40492 100882 90487063
Inability to afford medication 20.02 14.84 15 40487 3607 90584338
Epilepsy 19.88 14.84 6 40496 82200 90505745
Autoimmune disorder 19.68 14.84 5 40497 76739 90511206
Asthma 19.66 14.84 50 40452 242110 90345835
Emphysematous pyelonephritis 19.61 14.84 7 40495 351 90587594
Pemphigoid 19.36 14.84 22 40480 9004 90578941
Genital candidiasis 18.99 14.84 6 40496 206 90587739
Hyponatraemia 18.86 14.84 113 40389 133425 90454520
Knee arthroplasty 18.50 14.84 7 40495 83175 90504770
Latent autoimmune diabetes in adults 18.31 14.84 4 40498 30 90587915
Red blood cell sedimentation rate increased 18.29 14.84 7 40495 82588 90505357
White blood cell count decreased 18.28 14.84 29 40473 167080 90420865
Conjunctival discolouration 18.25 14.84 5 40497 103 90587842
Haemoglobin abnormal 18.18 14.84 19 40483 7081 90580864
Road traffic accident 18.11 14.84 13 40489 107613 90480332
Urinary retention 18.04 14.84 47 40455 37697 90550248
Mouth swelling 17.92 14.84 17 40485 5645 90582300
Neck pain 17.61 14.84 15 40487 113948 90473997
Urinary tract disorder 17.53 14.84 14 40488 3697 90584248
Blood glucose fluctuation 17.51 14.84 16 40486 5067 90582878
Cardiac failure acute 17.44 14.84 24 40478 11905 90576040
Shock symptom 17.33 14.84 6 40496 275 90587670
Cardiac murmur 17.30 14.84 30 40472 18164 90569781
Arthralgia 17.13 14.84 245 40257 778277 89809668
Pruritus 17.04 14.84 338 40164 541187 90046758
Fatigue 16.95 14.84 390 40112 1153633 89434312
Pyuria 16.92 14.84 11 40491 2108 90585837
Impaired quality of life 16.81 14.84 34 40468 23110 90564835
Dyspepsia 16.80 14.84 40 40462 198120 90389825
Aspartate aminotransferase increased 16.59 14.84 13 40489 102924 90485021
Gingival pain 16.56 14.84 21 40481 9631 90578314
Capillary leak syndrome 16.51 14.84 12 40490 2755 90585190
Type 2 diabetes mellitus 16.46 14.84 42 40460 203202 90384743
Ear pain 16.34 14.84 3 40499 57699 90530246
Upper respiratory tract infection 16.30 14.84 20 40482 128298 90459647
Urinary incontinence 16.17 14.84 45 40457 37521 90550424
Liver function test increased 15.99 14.84 9 40493 84846 90503099
Portal fibrosis 15.91 14.84 6 40496 352 90587593
Congestive cardiomyopathy 15.90 14.84 18 40484 7336 90580609
Injection site reaction 15.65 14.84 11 40491 92069 90495876
Immune-mediated myositis 15.59 14.84 11 40491 2410 90585535
Weight increased 15.58 14.84 116 40386 417811 90170134
Product quality issue 15.55 14.84 8 40494 79317 90508628
Feeding disorder 15.52 14.84 28 40474 17484 90570461
Nasal congestion 15.50 14.84 9 40493 83405 90504540
Blood bilirubin unconjugated decreased 15.44 14.84 4 40498 66 90587879
Chest pain 15.41 14.84 214 40288 319431 90268514
Hepatic cytolysis 15.30 14.84 39 40463 30877 90557068
Hypovolaemia 15.24 14.84 23 40479 12408 90575537
Product use issue 15.13 14.84 86 40416 329833 90258112
Perineal cellulitis 15.13 14.84 3 40499 13 90587932
Ejection fraction decreased 14.99 14.84 35 40467 26218 90561727
Ventricular hypokinesia 14.96 14.84 15 40487 5326 90582619

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
Diabetic ketoacidosis 1919.39 13.83 786 49137 21581 42549831
Euglycaemic diabetic ketoacidosis 1018.31 13.83 343 49580 5317 42566095
Ketoacidosis 890.90 13.83 306 49617 5046 42566366
Death 536.57 13.83 1476 48447 469709 42101703
Ketosis 392.55 13.83 108 49815 797 42570615
Phimosis 283.82 13.83 89 49834 1082 42570330
Glomerular filtration rate decreased 267.72 13.83 191 49732 16160 42555252
Pruritus genital 254.33 13.83 101 49822 2538 42568874
Balanoposthitis 251.56 13.83 88 49835 1533 42569879
Metabolic acidosis 242.07 13.83 301 49622 51557 42519855
Acute kidney injury 199.69 13.83 904 49019 366433 42204979
Glycosylated haemoglobin increased 197.94 13.83 145 49778 12779 42558633
Cardiospasm 197.88 13.83 77 49846 1830 42569582
Urine ketone body present 194.75 13.83 70 49853 1324 42570088
Lactic acidosis 180.34 13.83 243 49680 45018 42526394
Palmoplantar keratoderma 178.69 13.83 75 49848 2179 42569233
Blood ketone body increased 173.73 13.83 51 49872 487 42570925
Sleep terror 166.11 13.83 77 49846 2849 42568563
Migraine 164.97 13.83 175 49748 25239 42546173
Cardiac failure 162.28 13.83 375 49548 106481 42464931
Palpitations 153.15 13.83 239 49684 50558 42520854
Atrial tachycardia 151.97 13.83 81 49842 4059 42567353
Tension headache 151.85 13.83 76 49847 3338 42568074
Toxicity to various agents 149.01 13.83 42 49881 229094 42342318
Tinnitus 146.36 13.83 175 49748 28763 42542649
Carotid artery occlusion 142.63 13.83 78 49845 4116 42567296
Diabetes mellitus inadequate control 141.05 13.83 128 49795 15262 42556150
Facial pain 136.01 13.83 76 49847 4184 42567228
Burns second degree 135.22 13.83 86 49837 6010 42565402
Hyperkalaemia 135.13 13.83 294 49629 80164 42491248
Blood glucose increased 134.99 13.83 279 49644 73420 42497992
Catarrh 134.16 13.83 85 49838 5901 42565511
Immunisation 131.25 13.83 51 49872 1207 42570205
Urinary tract infection 130.94 13.83 330 49593 98954 42472458
Diabetic ketosis 130.45 13.83 35 49888 232 42571180
Ketonuria 130.34 13.83 43 49880 621 42570791
Anosmia 129.93 13.83 79 49844 5097 42566315
Drug ineffective 127.01 13.83 352 49571 629845 41941567
Steroid dependence 125.16 13.83 85 49838 6637 42564775
Dehydration 123.61 13.83 406 49517 141361 42430051
Parosmia 121.64 13.83 88 49835 7603 42563809
Necrotising fasciitis 118.28 13.83 71 49852 4475 42566937
Polycythaemia 115.99 13.83 60 49863 2826 42568586
Hypopnoea 115.21 13.83 86 49837 7796 42563616
Ventricular tachycardia 114.15 13.83 158 49765 30002 42541410
Gingival pain 113.84 13.83 88 49835 8406 42563006
Renal impairment 112.04 13.83 333 49590 109895 42461517
Febrile neutropenia 111.81 13.83 39 49884 185664 42385748
Neutropenia 109.99 13.83 48 49875 199383 42372029
Fungal infection 105.90 13.83 123 49800 19599 42551813
Glomerular filtration rate abnormal 104.83 13.83 43 49880 1177 42570235
Systemic lupus erythematosus 104.52 13.83 87 49836 9237 42562175
Eye pruritus 102.78 13.83 94 49829 11318 42560094
Tubulointerstitial nephritis 98.64 13.83 151 49772 31397 42540015
Pain of skin 93.92 13.83 77 49846 8003 42563409
Impaired work ability 90.65 13.83 90 49833 12001 42559411
Cardiac failure chronic 90.23 13.83 81 49842 9520 42561892
N-terminal prohormone brain natriuretic peptide increased 90.02 13.83 54 49869 3399 42568013
Blindness 89.70 13.83 108 49815 17870 42553542
Abdominal discomfort 88.77 13.83 240 49683 75015 42496397
Drug abuse 87.77 13.83 10 49913 104761 42466651
Marasmus 85.20 13.83 34 49889 865 42570547
Rhinitis 84.02 13.83 86 49837 11891 42559521
Cardiac murmur 82.93 13.83 88 49835 12687 42558725
Lipoprotein (a) increased 81.31 13.83 26 49897 338 42571074
Pollakiuria 80.84 13.83 115 49808 22390 42549022
Lip swelling 79.99 13.83 105 49818 18948 42552464
Weight decreased 79.10 13.83 464 49459 207484 42363928
Colitis ulcerative 77.24 13.83 122 49801 26053 42545359
Toe amputation 76.86 13.83 46 49877 2883 42568529
Ejection fraction decreased 76.61 13.83 111 49812 21976 42549436
Completed suicide 76.47 13.83 11 49912 96454 42474958
Nightmare 74.38 13.83 117 49806 24895 42546517
Disease progression 73.89 13.83 38 49885 143618 42427794
Swollen tongue 72.62 13.83 106 49817 21125 42550287
Pericarditis 72.42 13.83 84 49839 13360 42558052
Hypoglycaemic coma 71.76 13.83 43 49880 2701 42568711
Hypoglycaemia 70.68 13.83 191 49732 59663 42511749
Impaired quality of life 68.82 13.83 84 49839 14093 42557319
Muscle twitching 67.51 13.83 76 49847 11704 42559708
Alcohol poisoning 67.45 13.83 62 49861 7512 42563900
Rash papular 67.35 13.83 76 49847 11735 42559677
Medication error 67.20 13.83 131 49792 33023 42538389
Polyuria 65.05 13.83 69 49854 9942 42561470
White blood cell count decreased 65 13.83 24 49899 110372 42461040
Urosepsis 63.40 13.83 83 49840 14937 42556475
Orchitis 63.38 13.83 37 49886 2214 42569198
Hyperglycaemic hyperosmolar nonketotic syndrome 63.19 13.83 33 49890 1585 42569827
Pneumonia 62.84 13.83 268 49655 421881 42149531
Subarachnoid haemorrhage 62.69 13.83 81 49842 14391 42557021
Genital erythema 60.86 13.83 20 49903 285 42571127
Scrotal abscess 60.51 13.83 25 49898 697 42570715
Glucose urine present 59.36 13.83 30 49893 1345 42570067
Frequent bowel movements 59.35 13.83 97 49826 21310 42550102
Peripheral arterial occlusive disease 59.00 13.83 55 49868 6783 42564629
Bronchiectasis 58.80 13.83 88 49835 17931 42553481
Acquired phimosis 58.61 13.83 17 49906 155 42571257
Malignant neoplasm progression 58.27 13.83 27 49896 108373 42463039
Vasculitis 57.42 13.83 88 49835 18306 42553106
Genital swelling 55.47 13.83 18 49905 246 42571166
Glycosuria 53.67 13.83 28 49895 1342 42570070
Disturbance in attention 52.21 13.83 111 49812 29755 42541657
COVID-19 50.15 13.83 268 49655 115680 42455732
Urine albumin/creatinine ratio increased 49.78 13.83 20 49903 518 42570894
Genital infection fungal 49.55 13.83 16 49907 215 42571197
Pancytopenia 48.50 13.83 40 49883 117703 42453709
Leukopenia 47.94 13.83 14 49909 74732 42496680
Urine protein/creatinine ratio increased 47.93 13.83 22 49901 795 42570617
Type V hyperlipidaemia 47.55 13.83 23 49900 937 42570475
Agitation 47.25 13.83 9 49914 64305 42507107
Diplopia 47.05 13.83 85 49838 20231 42551181
Eczema 46.64 13.83 115 49808 33971 42537441
Anaemia 46.01 13.83 171 49752 280107 42291305
Seizure 46.00 13.83 44 49879 120517 42450895
Congestive cardiomyopathy 45.94 13.83 54 49869 8710 42562702
Cough 45.68 13.83 87 49836 178016 42393396
Multiple organ dysfunction syndrome 45.12 13.83 29 49894 97006 42474406
Therapeutic product effect incomplete 44.21 13.83 14 49909 70925 42500487
Hyperglycaemia 44.12 13.83 136 49787 45723 42525689
Epididymitis 44.10 13.83 33 49890 3001 42568411
Dizziness 43.22 13.83 464 49459 248790 42322622
Dysgeusia 42.26 13.83 111 49812 34078 42537334
Genital infection 41.46 13.83 10 49913 40 42571372
Cardiac amyloidosis 41.29 13.83 27 49896 1978 42569434
Thirst 41.05 13.83 52 49871 9056 42562356
Adverse drug reaction 40.75 13.83 116 49807 37318 42534094
Thrombocytopenia 40.52 13.83 103 49820 190176 42381236
Cerebral infarction 40.38 13.83 103 49820 31066 42540346
Treatment failure 39.67 13.83 12 49911 62612 42508800
Transient ischaemic attack 39.14 13.83 107 49816 33632 42537780
Genital infection male 39.07 13.83 9 49914 28 42571384
Pyelonephritis 38.58 13.83 47 49876 7867 42563545
Foot amputation 37.88 13.83 19 49904 838 42570574
Extremity necrosis 37.73 13.83 27 49896 2292 42569120
Prostatic abscess 37.38 13.83 18 49905 726 42570686
Blood ketone body present 37.05 13.83 10 49913 68 42571344
Neutrophil count decreased 36.95 13.83 14 49909 63401 42508011
Perineal abscess 36.76 13.83 15 49908 405 42571007
Gangrene 36.30 13.83 37 49886 5089 42566323
Chronic kidney disease 35.58 13.83 129 49794 47112 42524300
Cardiac failure acute 35.41 13.83 60 49863 13573 42557839
Type 2 diabetes mellitus 35.03 13.83 71 49852 18400 42553012
Microalbuminuria 34.63 13.83 18 49905 856 42570556
Renal phospholipidosis 34.26 13.83 11 49912 145 42571267
Mucosal inflammation 34.03 13.83 8 49915 49366 42522046
Accidental overdose 33.01 13.83 90 49833 28240 42543172
Blood glucose abnormal 32.95 13.83 41 49882 7012 42564400
Bladder cancer 32.90 13.83 66 49857 16981 42554431
Amnesia 32.80 13.83 90 49833 28347 42543065
Thrombosis 32.50 13.83 20 49903 68491 42502921
Respiratory failure 32.47 13.83 63 49860 128069 42443343
Therapy non-responder 32.42 13.83 11 49912 53348 42518064
Acetonaemia 32.35 13.83 12 49911 249 42571163
Hypoxia 32.24 13.83 21 49902 69765 42501647
Vertigo 32.24 13.83 101 49822 34246 42537166
Mitral valve incompetence 32.01 13.83 64 49859 16425 42554987
Platelet count decreased 31.87 13.83 72 49851 138509 42432903
Arthritis 31.79 13.83 115 49808 41950 42529462
Body mass index increased 31.58 13.83 19 49904 1202 42570210
Cellulitis gangrenous 31.49 13.83 12 49911 269 42571143
Blood creatine decreased 31.49 13.83 12 49911 269 42571143
Off label use 31.42 13.83 543 49380 637792 41933620
Myelosuppression 31.17 13.83 5 49918 40456 42530956
Pancreatitis 30.78 13.83 116 49807 43152 42528260
Intentional product use issue 30.33 13.83 165 49758 71668 42499744
Visual impairment 30.18 13.83 115 49808 42998 42528414
Glomerular filtration rate increased 30.08 13.83 16 49907 798 42570614
Genital rash 29.75 13.83 16 49907 816 42570596
Anal abscess 29.50 13.83 41 49882 7809 42563603
Testicular swelling 29.44 13.83 22 49901 1997 42569415
Unevaluable event 29.39 13.83 3 49920 34285 42537127
Nasopharyngitis 29.38 13.83 33 49890 83963 42487449
Overdose 29.14 13.83 49 49874 105215 42466197
Atrial enlargement 28.85 13.83 15 49908 714 42570698
Chills 28.70 13.83 41 49882 94025 42477387
Angioedema 28.67 13.83 112 49811 42365 42529047
Procalcitonin decreased 28.56 13.83 11 49912 254 42571158
Bone marrow failure 28.10 13.83 3 49920 33090 42538322
Eosinophil percentage decreased 28.08 13.83 11 49912 266 42571146
Low density lipoprotein increased 28.07 13.83 33 49890 5322 42566090
Ventricular internal diameter abnormal 27.87 13.83 10 49913 188 42571224
Stomatitis 27.87 13.83 12 49911 50317 42521095
Blood pressure decreased 27.39 13.83 138 49785 58194 42513218
Enzyme inhibition 27.29 13.83 8 49915 76 42571336
Cytomegalovirus infection 27.25 13.83 3 49920 32303 42539109
Haemoglobin decreased 27.19 13.83 73 49850 132398 42439014
Glycosylated haemoglobin abnormal 26.95 13.83 11 49912 297 42571115
Pancreatitis acute 26.42 13.83 93 49830 33471 42537941
Staphylococcal infection 26.14 13.83 6 49917 37637 42533775
Dysuria 26.08 13.83 88 49835 31008 42540404
Pyrexia 26.05 13.83 316 49607 393726 42177686
N-terminal prohormone brain natriuretic peptide abnormal 25.96 13.83 10 49913 231 42571181
Alopecia 25.57 13.83 84 49839 29192 42542220
Constipation 25.30 13.83 101 49822 162190 42409222
Drug hypersensitivity 25.06 13.83 49 49874 99340 42472072
Full blood count abnormal 24.64 13.83 3 49920 29873 42541539
Cognitive disorder 24.62 13.83 92 49831 34080 42537332
Dry skin 24.58 13.83 117 49806 48221 42523191
Inferior vena cava syndrome 24.52 13.83 7 49916 60 42571352
Emphysematous cystitis 24.37 13.83 10 49913 274 42571138
Aspartate aminotransferase increased 24.17 13.83 33 49890 77130 42494282
Scrotal gangrene 23.96 13.83 6 49917 29 42571383
Hypotension 23.85 13.83 429 49494 257202 42314210
Proteinuria 23.83 13.83 70 49853 22913 42548499
Gastroduodenal ulcer 23.49 13.83 13 49910 702 42570710
Urinary tract infection fungal 23.12 13.83 12 49911 569 42570843
Intentional overdose 23.07 13.83 16 49907 51440 42519972
Chronic left ventricular failure 22.72 13.83 13 49910 749 42570663
Epistaxis 22.56 13.83 27 49896 66799 42504613
Carotid arteriosclerosis 22.55 13.83 20 49903 2312 42569100
Haematochezia 22.52 13.83 131 49792 58305 42513107
Thrombotic cerebral infarction 22.52 13.83 11 49912 458 42570954
NYHA classification 22.46 13.83 6 49917 39 42571373
Haemoglobin increased 22.32 13.83 29 49894 5177 42566235
Mitral valve thickening 22.27 13.83 11 49912 469 42570943
Onychoclasis 22.24 13.83 21 49902 2631 42568781
Therapeutic product effect decreased 22.22 13.83 9 49914 39141 42532271
Aggression 22.21 13.83 12 49911 44151 42527261
Musculoskeletal stiffness 22.11 13.83 21 49902 57744 42513668
Perineal cellulitis 22.10 13.83 5 49918 14 42571398
Inability to afford medication 22.07 13.83 19 49904 2111 42569301
Mitral valve calcification 21.98 13.83 12 49911 631 42570781
Urethritis 21.95 13.83 11 49912 484 42570928
Upper respiratory tract infection 21.89 13.83 11 49912 42162 42529250
Productive cough 21.87 13.83 17 49906 51550 42519862
Therapeutic response decreased 21.85 13.83 8 49915 37004 42534408
Mental status changes 21.84 13.83 11 49912 42104 42529308
Incorrect dose administered 21.79 13.83 18 49905 52956 42518456
Suspected COVID-19 21.79 13.83 16 49907 1414 42569998
Cerebrovascular accident 21.76 13.83 191 49732 96969 42474443
Blood creatine increased 21.76 13.83 30 49893 5670 42565742
Psychotic disorder 21.64 13.83 4 49919 29204 42542208
Hypovolaemia 21.60 13.83 44 49879 11441 42559971
Heart rate increased 21.58 13.83 121 49802 53134 42518278
Urinary tract candidiasis 21.54 13.83 11 49912 504 42570908
Pallor 21.30 13.83 4 49919 28882 42542530
Disorientation 21.25 13.83 8 49915 36381 42535031
Drug ineffective for unapproved indication 21.17 13.83 14 49909 46149 42525263
Hospitalisation 21.12 13.83 34 49889 74296 42497116
Suicide attempt 21.12 13.83 14 49909 46086 42525326
Product dose omission issue 21.06 13.83 101 49822 154264 42417148
Plasma cell myeloma 21.06 13.83 15 49908 47563 42523849
Respiratory arrest 20.83 13.83 4 49919 28420 42542992
Left ventricular false tendon 20.75 13.83 6 49917 54 42571358
Blood potassium increased 20.72 13.83 58 49865 18478 42552934
Cardio-respiratory arrest 20.54 13.83 23 49900 58613 42512799
Total cholesterol/HDL ratio increased 20.40 13.83 8 49915 194 42571218
Systemic candida 20.31 13.83 28 49895 5291 42566121
Rectal haemorrhage 20.30 13.83 113 49810 49493 42521919
International normalised ratio increased 20.27 13.83 16 49907 48152 42523260
Lung diffusion test abnormal 20.01 13.83 6 49917 62 42571350
Fall 20.00 13.83 177 49746 234343 42337069
Arthropathy 19.99 13.83 5 49918 29592 42541820
Cardiac pacemaker evaluation 19.84 13.83 7 49916 125 42571287
Labyrinthitis 19.73 13.83 13 49910 965 42570447
Restlessness 19.65 13.83 5 49918 29244 42542168
Neoplasm progression 19.40 13.83 5 49918 28995 42542417
Gait disturbance 19.36 13.83 55 49868 97945 42473467
Left ventricular dysfunction 19.24 13.83 42 49881 11459 42559953
Hepatic cytolysis 19.11 13.83 72 49851 26772 42544640
Tricuspid valve incompetence 19.07 13.83 41 49882 11072 42560340
Infusion related reaction 19.04 13.83 26 49897 60780 42510632
Haematocrit increased 19.04 13.83 19 49904 2548 42568864
Depressed level of consciousness 18.88 13.83 17 49906 47953 42523459
Injection site pain 18.83 13.83 24 49899 57774 42513638
Generalised tonic-clonic seizure 18.73 13.83 4 49919 26375 42545037
Tremor 18.71 13.83 55 49868 96874 42474538
Hypovolaemic shock 18.50 13.83 35 49888 8624 42562788
Sinusitis 18.33 13.83 17 49906 47275 42524137
Starvation 18.31 13.83 10 49913 526 42570886
Atrioventricular block 18.28 13.83 37 49886 9578 42561834
Haematuria 18.17 13.83 123 49800 57676 42513736
Perineal necrosis 18.04 13.83 5 49918 38 42571374
Myocardial infarction 17.91 13.83 223 49700 123786 42447626
Paraesthesia 17.84 13.83 37 49886 73422 42497990
Acute myocardial infarction 17.83 13.83 123 49800 58042 42513370
Aortic valve calcification 17.82 13.83 10 49913 555 42570857
Chronic obstructive pulmonary disease 17.81 13.83 29 49894 63085 42508327
Dyskinesia 17.72 13.83 4 49919 25386 42546026
Blood creatinine abnormal 17.61 13.83 20 49903 3109 42568303
Wheezing 17.59 13.83 23 49900 54758 42516654
Balanitis candida 17.40 13.83 7 49916 182 42571230
Splinter haemorrhages 17.39 13.83 6 49917 100 42571312
Shock haemorrhagic 17.35 13.83 50 49873 16192 42555220
Hyperlipasaemia 17.30 13.83 10 49913 587 42570825
Balanoposthitis infective 17.25 13.83 3 49920 0 42571412
Vulvovaginal pruritus 17.25 13.83 3 49920 0 42571412
Oxygen saturation decreased 17.08 13.83 31 49892 64656 42506756
Lymphadenopathy 16.87 13.83 9 49914 33356 42538056
Abnormal behaviour 16.87 13.83 5 49918 26446 42544966
Ventricular arrhythmia 16.79 13.83 28 49895 6251 42565161
Supraventricular extrasystoles 16.69 13.83 22 49901 3984 42567428
Infection 16.67 13.83 71 49852 111997 42459415
Electrocardiogram QT prolonged 16.58 13.83 19 49904 47926 42523486
Malaise 16.46 13.83 344 49579 211812 42359600
Alanine aminotransferase increased 16.46 13.83 51 49872 88355 42483057
Renal atrophy 16.34 13.83 13 49910 1294 42570118
Stress 16.32 13.83 98 49825 44114 42527298
Urine ketone body 16.31 13.83 5 49918 56 42571356
Penile oedema 16.28 13.83 9 49914 485 42570927
Interstitial lung disease 16.27 13.83 43 49880 78419 42492993
Respiratory distress 16.24 13.83 15 49908 41805 42529607
Scrotal inflammation 16.21 13.83 4 49919 18 42571394
Muscular weakness 16.11 13.83 159 49764 83339 42488073
Blood folate decreased 16.06 13.83 11 49912 870 42570542
Hypertrophy 15.96 13.83 9 49914 504 42570908
Urine albumin/creatinine ratio abnormal 15.86 13.83 4 49919 20 42571392
Pneumothorax 15.86 13.83 4 49919 23539 42547873
Suicidal ideation 15.69 13.83 20 49903 48141 42523271
Duodenal ulcer haemorrhage 15.67 13.83 26 49897 5782 42565630
Pneumocystis jirovecii pneumonia 15.63 13.83 5 49918 25176 42546236
Prostate examination abnormal 15.56 13.83 8 49915 372 42571040
Transferrin saturation decreased 15.53 13.83 9 49914 531 42570881
Hypersensitivity 15.51 13.83 39 49884 72331 42499081
Drug reaction with eosinophilia and systemic symptoms 15.29 13.83 16 49907 42059 42529353
Pancreatitis necrotising 15.14 13.83 20 49903 3629 42567783
Ascites 15.11 13.83 27 49896 56651 42514761
Pancreatic carcinoma 15.09 13.83 34 49889 9472 42561940
Myelodysplastic syndrome 15.06 13.83 4 49919 22741 42548671
Bronchitis 14.96 13.83 20 49903 47181 42524231
Urine output increased 14.96 13.83 13 49910 1463 42569949
Renal hypertension 14.95 13.83 7 49916 265 42571147
Bladder cancer recurrent 14.89 13.83 8 49915 407 42571005
Groin pain 14.72 13.83 26 49897 6078 42565334
Erectile dysfunction 14.68 13.83 63 49860 24850 42546562
Diabetic foot 14.57 13.83 18 49905 3055 42568357
Stevens-Johnson syndrome 14.50 13.83 4 49919 22174 42549238
Liver disorder 14.50 13.83 15 49908 39629 42531783
Coagulopathy 14.48 13.83 4 49919 22158 42549254
Scrotal cellulitis 14.40 13.83 5 49918 85 42571327
Bulbar palsy 14.38 13.83 7 49916 289 42571123
Neuralgia 14.38 13.83 6 49917 25641 42545771
Dermatitis allergic 14.21 13.83 31 49892 8452 42562960
Diabetic ketoacidotic hyperglycaemic coma 14.05 13.83 6 49917 182 42571230
Urethral abscess 13.96 13.83 3 49920 6 42571406
Pemphigoid 13.93 13.83 37 49886 11430 42559982
Peripheral circulatory failure 13.84 13.83 6 49917 189 42571223

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
Diabetic ketoacidosis 3966.64 13.41 1384 77148 40674 110470093
Euglycaemic diabetic ketoacidosis 1999.43 13.41 604 77928 11019 110499748
Ketoacidosis 1833.55 13.41 547 77985 9540 110501227
Acute kidney injury 749.26 13.41 1491 77041 633939 109876828
Ketosis 726.62 13.41 182 78350 1572 110509195
Pruritus genital 618.88 13.41 216 78316 6306 110504461
Metabolic acidosis 489.40 13.41 469 78063 99275 110411492
Cardiospasm 465.51 13.41 163 78369 4804 110505963
Lactic acidosis 454.56 13.41 436 78096 92375 110418392
Palmoplantar keratoderma 445.08 13.41 161 78371 5226 110505541
Sleep terror 409.47 13.41 160 78372 6450 110504317
Glomerular filtration rate decreased 405.43 13.41 254 78278 28702 110482065
Dehydration 400.22 13.41 714 77818 278797 110231970
Atrial tachycardia 374.87 13.41 165 78367 9013 110501754
Carotid artery occlusion 371.52 13.41 166 78366 9399 110501368
Glycosylated haemoglobin increased 358.15 13.41 218 78314 23401 110487366
Hyperkalaemia 357.54 13.41 461 78071 135335 110375432
Tension headache 351.60 13.41 160 78372 9458 110501309
Urine ketone body present 340.54 13.41 121 78411 3725 110507042
Diabetes mellitus inadequate control 323.75 13.41 223 78309 29552 110481215
Anosmia 320.76 13.41 163 78369 12309 110498458
Cardiac failure 311.40 13.41 512 78020 187114 110323653
Blood glucose increased 309.11 13.41 424 78108 132072 110378695
Blood ketone body increased 308.12 13.41 80 78452 808 110509959
Immunisation 308.06 13.41 107 78425 3076 110507691
Tinnitus 293.66 13.41 283 78249 60257 110450510
Facial pain 286.36 13.41 162 78370 15177 110495590
Ventricular tachycardia 285.50 13.41 256 78276 49753 110461014
Diabetic ketosis 275.43 13.41 74 78458 862 110509905
Hypoglycaemia 256.52 13.41 362 78170 115742 110395025
Pain of skin 241.61 13.41 160 78372 19869 110490898
Palpitations 238.29 13.41 415 78117 158797 110351970
Renal impairment 228.98 13.41 449 78083 187996 110322771
Balanoposthitis 221.51 13.41 68 78464 1308 110509459
Eye pruritus 217.81 13.41 183 78349 32592 110478175
Phimosis 212.75 13.41 59 78473 780 110509987
Subarachnoid haemorrhage 212.30 13.41 173 78359 29529 110481238
Catarrh 206.68 13.41 102 78430 7233 110503534
Burns second degree 204.50 13.41 103 78429 7630 110503137
Urinary tract infection 201.55 13.41 598 77934 325684 110185083
Ketonuria 197.87 13.41 63 78469 1372 110509395
Hypoglycaemic coma 195.80 13.41 90 78442 5443 110505324
Vasculitis 193.68 13.41 178 78354 35695 110475072
Steroid dependence 192.82 13.41 102 78430 8367 110502400
Necrotising fasciitis 191.68 13.41 98 78434 7493 110503274
Muscle twitching 190.42 13.41 163 78369 29772 110480995
Lip swelling 189.62 13.41 206 78326 50461 110460306
Blindness 183.94 13.41 174 78358 36185 110474582
Drug ineffective 182.58 13.41 519 78013 1520021 108990746
Marasmus 175.90 13.41 60 78472 1631 110509136
Death 173.06 13.41 963 77569 697906 109812861
Hypopnoea 172.41 13.41 105 78427 11275 110499492
Infusion related reaction 168.59 13.41 33 78499 381129 110129638
Diplopia 161.44 13.41 173 78359 41721 110469046
COVID-19 158.77 13.41 457 78075 244603 110266164
Parosmia 158.26 13.41 105 78427 13075 110497692
Arthropathy 152.89 13.41 14 78518 287508 110223259
Disturbance in attention 149.94 13.41 202 78330 61793 110448974
Fungal infection 148.75 13.41 182 78350 50624 110460143
Pollakiuria 147.03 13.41 169 78363 44026 110466741
Glucose urine present 143.86 13.41 56 78476 2233 110508534
Vulvovaginal pruritus 142.89 13.41 62 78470 3269 110507498
Tubulointerstitial nephritis 142.28 13.41 184 78348 54100 110456667
Gingival pain 141.47 13.41 105 78427 15631 110495136
Rash papular 139.29 13.41 132 78400 27507 110483260
Transient ischaemic attack 139.04 13.41 198 78334 63784 110446983
Treatment failure 138.44 13.41 17 78515 277217 110233550
Polycythaemia 137.37 13.41 60 78472 3215 110507552
Maternal exposure during pregnancy 136.62 13.41 12 78520 254871 110255896
Pemphigus 133.95 13.41 4 78528 214566 110296201
Joint swelling 132.34 13.41 75 78457 442770 110067997
Completed suicide 131.03 13.41 11 78521 242370 110268397
Nasopharyngitis 129.47 13.41 59 78473 394302 110116465
Hypersensitivity 128.70 13.41 63 78469 403935 110106832
Cardiac failure chronic 128.31 13.41 94 78438 13717 110497050
Wound 125.75 13.41 11 78521 234426 110276341
Weight decreased 122.37 13.41 655 77877 467402 110043365
Toxicity to various agents 121.36 13.41 98 78434 480457 110030310
Polyuria 119.82 13.41 100 78432 17638 110493129
Therapeutic product effect decreased 119.52 13.41 16 78516 244300 110266467
Hyperglycaemia 117.20 13.41 214 78318 84876 110425891
Stomatitis 116.13 13.41 25 78507 270217 110240550
Drug hypersensitivity 115.41 13.41 92 78440 453998 110056769
N-terminal prohormone brain natriuretic peptide increased 115.19 13.41 65 78467 6056 110504711
Sinusitis 114.87 13.41 34 78498 296654 110214113
Cardiac murmur 113.52 13.41 112 78420 24516 110486251
Nightmare 113.41 13.41 139 78393 38724 110472043
Musculoskeletal stiffness 112.17 13.41 30 78502 279792 110230975
Duodenal ulcer perforation 112.07 13.41 3 78529 177697 110333070
Cerebral infarction 112.01 13.41 160 78372 51678 110459089
Angioedema 110.33 13.41 227 78305 98273 110412494
Urosepsis 106.61 13.41 120 78412 30555 110480212
Drug intolerance 106.29 13.41 80 78452 406432 110104335
Swelling 105.49 13.41 59 78473 350982 110159785
Rhinitis 104.80 13.41 103 78429 22442 110488325
Toe amputation 103.75 13.41 54 78478 4284 110506483
Folliculitis 101.57 13.41 4 78528 167649 110343118
Hyperglycaemic hyperosmolar nonketotic syndrome 100.42 13.41 47 78485 2962 110507805
Ejection fraction decreased 98.53 13.41 133 78399 40747 110470020
Dry skin 97.74 13.41 228 78304 107425 110403342
Neutropenia 96.30 13.41 75 78457 374545 110136222
Psoriatic arthropathy 95.96 13.41 13 78519 196748 110314019
Lower respiratory tract infection 95.68 13.41 27 78505 243079 110267688
Diabetic metabolic decompensation 94.70 13.41 49 78483 3840 110506927
Impaired work ability 94.64 13.41 105 78427 26314 110484453
Glomerular filtration rate abnormal 94.59 13.41 42 78490 2341 110508426
Fibromyalgia 94.48 13.41 7 78525 170902 110339865
Hepatic enzyme increased 93.47 13.41 56 78476 320836 110189931
Rheumatoid arthritis 91.98 13.41 49 78483 299564 110211203
Impaired healing 89.12 13.41 16 78516 196701 110314066
Dysuria 88.72 13.41 156 78376 60075 110450692
Cognitive disorder 87.97 13.41 193 78339 87318 110423449
Alcohol poisoning 87.44 13.41 63 78469 8957 110501810
Febrile neutropenia 84.51 13.41 61 78471 316706 110194061
Wheezing 84.01 13.41 38 78494 255192 110255575
Impaired quality of life 83.78 13.41 105 78427 29912 110480855
Migraine 82.56 13.41 289 78243 171363 110339404
Pancreatitis acute 82.24 13.41 151 78381 60123 110450644
Irritable bowel syndrome 82.12 13.41 10 78522 164205 110346562
Dizziness 81.08 13.41 804 77728 697389 109813378
Genital infection 80.53 13.41 21 78511 216 110510551
Hallucination 79.47 13.41 203 78329 101229 110409538
Orchitis 77.73 13.41 34 78498 1828 110508939
Exposure during pregnancy 77.19 13.41 13 78519 167411 110343356
Therapeutic product effect incomplete 75.75 13.41 32 78500 223773 110286994
Hypotension 75.39 13.41 632 77900 523217 109987550
Pyelonephritis 74.78 13.41 91 78441 25159 110485608
Myocardial infarction 74.61 13.41 302 78230 191781 110318986
Chronic kidney disease 73.02 13.41 165 78367 76126 110434641
Injury 72.95 13.41 18 78514 177247 110333520
Musculoskeletal pain 72.62 13.41 20 78512 183003 110327764
Eczema 72.16 13.41 159 78373 72134 110438633
Congestive cardiomyopathy 71.81 13.41 68 78464 14151 110496616
Bronchiectasis 70.69 13.41 107 78425 36386 110474381
Gait inability 68.95 13.41 8 78524 136368 110374399
Swollen tongue 66.27 13.41 138 78394 60224 110450543
Night sweats 64.97 13.41 9 78523 133974 110376793
Genital swelling 63.72 13.41 20 78512 415 110510352
Medication error 62.91 13.41 191 78341 105175 110405592
Congenital hydrocephalus 62.81 13.41 14 78518 68 110510699
Therapy non-responder 62.76 13.41 17 78515 157290 110353477
Drug abuse 62.26 13.41 24 78508 177387 110333380
Heart rate increased 62.23 13.41 234 78298 143600 110367167
White blood cell count decreased 61.39 13.41 44 78488 229346 110281421
Cardiac failure acute 60.57 13.41 80 78452 23998 110486769
Scrotal abscess 60.28 13.41 21 78511 609 110510158
Contusion 59.58 13.41 47 78485 233314 110277453
Visual impairment 59.24 13.41 220 78312 134208 110376559
Blood ketone body present 58.93 13.41 15 78517 139 110510628
Hyperhidrosis 58.62 13.41 276 78256 187022 110323745
Pneumonia 58.38 13.41 374 78158 876340 109634427
Blood glucose abnormal 58.16 13.41 58 78474 12858 110497909
Glycosuria 57.96 13.41 31 78501 2599 110508168
Acute myocardial infarction 57.85 13.41 160 78372 83617 110427150
Left ventricular dysfunction 57.47 13.41 77 78455 23416 110487351
Disease progression 56.42 13.41 54 78478 243980 110266787
Thirst 55.96 13.41 73 78459 21634 110489133
Acetonaemia 54.70 13.41 19 78513 546 110510221
Osteoarthritis 54.38 13.41 31 78501 182592 110328175
Blister 54.12 13.41 49 78483 227327 110283440
Blood creatinine increased 53.98 13.41 265 78267 182624 110328143
Dysgeusia 53.71 13.41 139 78393 69846 110440921
C-reactive protein abnormal 53.69 13.41 13 78519 129682 110381085
Accidental overdose 52.86 13.41 115 78417 51719 110459048
Lip dry 52.83 13.41 5 78527 100078 110410689
Microalbuminuria 52.77 13.41 23 78509 1226 110509541
Renal failure 52.38 13.41 307 78225 226267 110284500
Hypernatraemia 52.37 13.41 64 78468 17769 110492998
Type V hyperlipidaemia 52.10 13.41 24 78508 1458 110509309
Emphysematous cystitis 52.01 13.41 19 78513 634 110510133
Inflammation 51.79 13.41 37 78495 193201 110317566
Mitral valve incompetence 51.26 13.41 88 78444 33241 110477526
Genital erythema 50.89 13.41 16 78516 334 110510433
Colitis ulcerative 50.72 13.41 145 78387 77218 110433549
Hypoaesthesia 50.63 13.41 91 78441 314132 110196635
Wound infection 50.44 13.41 5 78527 96460 110414307
Asthma 49.48 13.41 63 78469 250228 110260539
Amnesia 49.39 13.41 176 78356 105232 110405535
Urine albumin/creatinine ratio increased 48.67 13.41 21 78511 1092 110509675
Epididymitis 48.43 13.41 27 78505 2457 110508310
Infection 48.17 13.41 117 78415 362083 110148684
Acidosis 47.86 13.41 69 78463 22462 110488305
Cardiac amyloidosis 47.71 13.41 28 78504 2809 110507958
Atrial fibrillation 46.68 13.41 301 78231 229341 110281426
Genital infection fungal 46.37 13.41 14 78518 254 110510513
Ill-defined disorder 46.17 13.41 27 78505 156826 110353941
Acquired phimosis 46.05 13.41 12 78520 123 110510644
Prostatic abscess 45.74 13.41 17 78515 596 110510171
Genital infection female 45.69 13.41 11 78521 79 110510688
Urinary tract infection fungal 45.62 13.41 21 78511 1274 110509493
Anal abscess 44.72 13.41 48 78484 11590 110499177
Paraesthesia 44.62 13.41 80 78452 276441 110234326
Peripheral arterial occlusive disease 44.25 13.41 43 78489 9237 110501530
Intentional product misuse 43.90 13.41 199 78333 132705 110378062
Blood cholesterol increased 43.75 13.41 40 78492 184745 110326022
Haematuria 42.72 13.41 143 78389 82862 110427905
Contraindicated product administered 42.65 13.41 69 78463 248198 110262569
Lung disorder 42.60 13.41 39 78493 180008 110330759
Hepatic cytolysis 41.89 13.41 109 78423 54944 110455823
Mobility decreased 41.71 13.41 65 78467 237357 110273410
Urticaria 41.61 13.41 104 78428 318753 110192014
Blood pressure decreased 41.56 13.41 177 78355 114914 110395853
Discomfort 41.45 13.41 55 78477 214652 110296115
Temperature perception test abnormal 40.90 13.41 8 78524 17 110510750
Pulmonary fibrosis 40.75 13.41 11 78521 102031 110408736
Agitation 40.15 13.41 15 78517 113036 110397731
Urine albumin/creatinine ratio abnormal 39.90 13.41 11 78521 142 110510625
Dermo-hypodermitis 39.87 13.41 20 78512 1468 110509299
Adverse event 39.38 13.41 14 78518 108795 110401972
Lower limb fracture 39.15 13.41 4 78528 75344 110435423
Red blood cell sedimentation rate increased 38.58 13.41 5 78527 78297 110432470
Candida infection 38.55 13.41 97 78435 47912 110462855
Glycosylated haemoglobin abnormal 38.24 13.41 14 78518 470 110510297
Thrombotic cerebral infarction 38.10 13.41 16 78516 778 110509989
Leukopenia 37.93 13.41 30 78502 148761 110362006
Vulvovaginitis 37.88 13.41 13 78519 360 110510407
Malignant neoplasm progression 37.65 13.41 41 78491 174526 110336241
Cough 37.11 13.41 185 78347 461456 110049311
Adverse drug reaction 37.08 13.41 161 78371 105398 110405369
Injection site pain 37.04 13.41 43 78489 177879 110332888
Feeling abnormal 36.80 13.41 237 78295 180474 110330293
Body mass index increased 36.58 13.41 22 78510 2308 110508459
Vertigo 36.46 13.41 140 78392 86730 110424037
Cellulitis gangrenous 36.19 13.41 13 78519 413 110510354
Urinary retention 35.82 13.41 120 78412 69563 110441204
Prescribed overdose 35.81 13.41 9 78523 87572 110423195
Extremity necrosis 35.59 13.41 26 78506 3776 110506991
Suspected COVID-19 35.24 13.41 25 78507 3468 110507299
Ischaemic stroke 34.85 13.41 85 78447 41178 110469589
Perineal abscess 34.51 13.41 15 78517 794 110509973
Product use issue 34.51 13.41 110 78422 311585 110199182
Perineal cellulitis 33.79 13.41 8 78524 53 110510714
Pancreatic carcinoma 33.74 13.41 47 78485 14825 110495942
Diabetic ketoacidotic hyperglycaemic coma 33.38 13.41 11 78521 268 110510499
Injection site reaction 33.03 13.41 11 78521 89059 110421708
Low density lipoprotein increased 32.49 13.41 39 78493 10627 110500140
Frequent bowel movements 32.42 13.41 118 78414 71272 110439495
Atrial enlargement 32.41 13.41 16 78516 1135 110509632
Pancreatitis 32.35 13.41 142 78390 93391 110417376
Testicular swelling 32.09 13.41 18 78514 1658 110509109
Vulvovaginal candidiasis 31.97 13.41 23 78509 3262 110507505
Urinary tract candidiasis 31.79 13.41 16 78516 1183 110509584
Leukocyturia 31.74 13.41 20 78512 2280 110508487
Hypovolaemia 31.73 13.41 56 78476 21618 110489149
Haematochezia 31.68 13.41 164 78368 115360 110395407
Upper respiratory tract infection 31.60 13.41 28 78504 131300 110379467
Neck pain 31.16 13.41 25 78507 123105 110387662
Thrombocytopenia 30.87 13.41 135 78397 348750 110162017
Hypoxia 30.70 13.41 28 78504 129487 110381280
Ventricular internal diameter abnormal 30.61 13.41 10 78522 237 110510530
Urine protein/creatinine ratio increased 30.40 13.41 17 78515 1556 110509211
Bladder trabeculation 30.19 13.41 8 78524 88 110510679
Hypovolaemic shock 30.02 13.41 44 78488 14539 110496228
Foot amputation 29.75 13.41 15 78517 1113 110509654
Systemic candida 29.62 13.41 36 78496 9938 110500829
Glomerular filtration rate increased 29.60 13.41 18 78514 1927 110508840
Renal phospholipidosis 29.56 13.41 11 78521 387 110510380
Cerebrovascular accident 29.42 13.41 225 78307 181059 110329708
Therapeutic response decreased 29.27 13.41 16 78516 96483 110414284
Dyspepsia 29.25 13.41 57 78475 190908 110319859
Pancreatitis necrotising 29.11 13.41 27 78505 5474 110505293
Hospitalisation 29.06 13.41 35 78497 142458 110368309
Sleep disorder 28.97 13.41 61 78471 198583 110312184
Gastroduodenal ulcer 28.84 13.41 14 78518 957 110509810
Blood ketone body 28.75 13.41 9 78523 185 110510582
Urogenital infection fungal 28.64 13.41 7 78525 54 110510713
Blood potassium increased 28.62 13.41 69 78463 33180 110477587
Bronchitis 28.53 13.41 42 78490 156990 110353777
Micturition urgency 28.39 13.41 50 78482 19270 110491497
Penile oedema 28.01 13.41 10 78522 312 110510455
N-terminal prohormone brain natriuretic peptide abnormal 27.98 13.41 10 78522 313 110510454
Aspartate aminotransferase increased 27.88 13.41 44 78488 159892 110350875
Product quality issue 27.88 13.41 10 78522 77289 110433478
Prerenal failure 27.78 13.41 24 78508 4435 110506332
Vomiting 27.15 13.41 842 77690 909833 109600934
Sciatica 27.05 13.41 16 78516 92383 110418384
Scrotal gangrene 26.94 13.41 6 78526 29 110510738
Metabolic alkalosis 26.82 13.41 26 78506 5569 110505198
Urethritis 26.75 13.41 12 78520 685 110510082
Myelosuppression 26.70 13.41 17 78515 94323 110416444
Anaemia 26.68 13.41 254 78278 546832 109963935
Polydipsia 26.58 13.41 30 78502 7658 110503109
Enzyme inhibition 26.50 13.41 8 78524 145 110510622
Unevaluable event 26.42 13.41 5 78527 59222 110451545
Pemphigoid 26.41 13.41 49 78483 19658 110491109
Gait disturbance 26.25 13.41 105 78427 278103 110232664
Coronary artery stenosis 26.16 13.41 40 78492 13718 110497049
Respiratory failure 25.98 13.41 73 78459 215259 110295508
Abdominal discomfort 25.85 13.41 408 78124 393450 110117317
Respiratory arrest 25.84 13.41 5 78527 58294 110452473
Road traffic accident 25.71 13.41 23 78509 107375 110403392
Disease risk factor 25.70 13.41 9 78523 265 110510502
Emphysematous pyelonephritis 25.58 13.41 11 78521 567 110510200
Urinary occult blood positive 25.48 13.41 9 78523 272 110510495
Heat illness 25.29 13.41 12 78520 780 110509987
Proteinuria 25.25 13.41 74 78458 39944 110470823
Atrioventricular block 25.22 13.41 44 78488 16833 110493934
Genital infection male 25.14 13.41 5 78527 12 110510755
Mucosal inflammation 24.99 13.41 19 78513 96122 110414645
Weight increased 24.89 13.41 185 78347 419459 110091308
Ear pain 24.82 13.41 4 78528 53222 110457545
NYHA classification 24.70 13.41 6 78526 45 110510722
Drug ineffective for unapproved indication 24.65 13.41 22 78510 102816 110407951
Peripartum cardiomyopathy 24.55 13.41 8 78524 188 110510579
Productive cough 24.47 13.41 27 78505 114278 110396489
Left ventricular false tendon 24.36 13.41 6 78526 48 110510719
Prostate examination abnormal 24.35 13.41 8 78524 193 110510574
Hip arthroplasty 24.29 13.41 5 78527 55808 110454959
Chills 24.20 13.41 63 78469 190517 110320250
Bladder cancer 24.18 13.41 48 78484 20244 110490523
Liver function test increased 23.66 13.41 17 78515 88531 110422236
Incorrect route of product administration 23.60 13.41 8 78524 64053 110446714
Product dose omission issue 23.58 13.41 133 78399 321649 110189118
Hypercholesterolaemia 23.54 13.41 18 78514 90819 110419948
Vulvovaginal discomfort 23.30 13.41 16 78516 2108 110508659
Hyperlipasaemia 23.22 13.41 14 78518 1475 110509292
Sarcopenia 23.14 13.41 13 78519 1201 110509566
Ventricular arrhythmia 23.07 13.41 32 78500 10055 110500712
Cardiac pacemaker evaluation 22.78 13.41 7 78525 135 110510632
Perineal pain 22.75 13.41 14 78518 1531 110509236
Rhabdomyolysis 22.74 13.41 155 78377 120246 110390521
Autoimmune disorder 22.73 13.41 9 78523 65474 110445293
Splinter haemorrhages 22.69 13.41 7 78525 137 110510630
Taste disorder 22.68 13.41 9 78523 65378 110445389
Blood creatine increased 22.62 13.41 34 78498 11487 110499280
Mitral valve thickening 22.58 13.41 11 78521 758 110510009
Exostosis 22.48 13.41 3 78529 45953 110464814
Nasal congestion 22.41 13.41 22 78510 98260 110412507
Neutrophil count decreased 22.31 13.41 32 78500 120909 110389858
Neoplasm progression 22.22 13.41 9 78523 64586 110446181
Epilepsy 22.20 13.41 23 78509 100186 110410581
Shock 22.19 13.41 86 78446 53502 110457265
C-reactive protein increased 22.00 13.41 80 78452 217839 110292928
Genital rash 21.99 13.41 13 78519 1322 110509445
Groin abscess 21.97 13.41 15 78517 1957 110508810
Pain 21.87 13.41 514 78018 954441 109556326
Renal atrophy 21.86 13.41 16 78516 2330 110508437
Deep vein thrombosis 21.80 13.41 172 78360 139715 110371052
Muscular weakness 21.79 13.41 271 78261 248197 110262570
Bone marrow failure 21.70 13.41 7 78525 57841 110452926
Condition aggravated 21.43 13.41 380 78152 734456 109776311
Testicular pain 21.37 13.41 16 78516 2413 110508354
Hypertensive heart disease 21.36 13.41 21 78511 4575 110506192
Vulvitis 21.35 13.41 8 78524 287 110510480
General physical health deterioration 21.34 13.41 196 78336 425099 110085668
Psychotic disorder 21.28 13.41 5 78527 50932 110459835
Pancytopenia 21.13 13.41 77 78455 209536 110301231
Balanitis candida 20.85 13.41 7 78525 181 110510586
Shock haemorrhagic 20.78 13.41 54 78478 27193 110483574
Drug interaction 20.75 13.41 483 78049 499700 110011067
Chest pain 20.73 13.41 379 78153 375996 110134771
Rectal haemorrhage 20.72 13.41 151 78381 119682 110391085
Duodenal ulcer haemorrhage 20.67 13.41 27 78505 8010 110502757
Full blood count abnormal 20.64 13.41 7 78525 56045 110454722
Scrotal inflammation 20.61 13.41 4 78528 8 110510759
Back pain 20.57 13.41 374 78158 370622 110140145
Platelet count decreased 20.47 13.41 89 78443 230354 110280413
Injection site erythema 20.43 13.41 22 78510 94154 110416613
Cardio-respiratory arrest 20.06 13.41 32 78500 115804 110394963
Blood glucose fluctuation 20.02 13.41 26 78506 7672 110503095
Tricuspid valve incompetence 19.97 13.41 49 78483 23824 110486943
Erectile dysfunction 19.87 13.41 42 78490 18514 110492253
Diabetic retinopathy 19.85 13.41 18 78514 3546 110507221
Generalised tonic-clonic seizure 19.84 13.41 7 78525 54673 110456094
Atrioventricular block complete 19.84 13.41 44 78488 20038 110490729
Mental status changes 19.84 13.41 15 78517 76107 110434660
Albumin urine present 19.82 13.41 10 78522 743 110510024
Pyelonephritis acute 19.76 13.41 25 78507 7188 110503579
Liver injury 19.65 13.41 49 78483 150364 110360403
Altered state of consciousness 19.56 13.41 87 78445 57539 110453228
Emotional distress 19.55 13.41 4 78528 44843 110465924
Alanine aminotransferase increased 19.53 13.41 66 78466 183707 110327060
Inferior vena cava syndrome 19.51 13.41 6 78526 116 110510651
Osteonecrosis of jaw 19.50 13.41 5 78527 48012 110462755
Knee arthroplasty 19.36 13.41 11 78521 64937 110445830
Hyperuricaemia 19.31 13.41 36 78496 14495 110496272
Hepatocellular injury 19.22 13.41 6 78526 50636 110460131
Aggression 19.18 13.41 9 78523 59201 110451566
Genital candidiasis 19.18 13.41 7 78525 233 110510534
Crush syndrome 19.09 13.41 8 78524 387 110510380
Vulvovaginal pain 18.94 13.41 16 78516 2868 110507899
Burning feet syndrome 18.76 13.41 7 78525 248 110510519
Glucose urine absent 18.75 13.41 3 78529 0 110510767
Testicular necrosis 18.75 13.41 3 78529 0 110510767
Haemoglobin decreased 18.66 13.41 102 78430 248625 110262142
Brain stem infarction 18.64 13.41 14 78518 2120 110508647
Total cholesterol/HDL ratio increased 18.61 13.41 8 78524 412 110510355
Ventricular extrasystoles 18.44 13.41 46 78486 22595 110488172
Liver disorder 18.07 13.41 47 78485 142196 110368571
Cytomegalovirus infection 18.07 13.41 8 78524 54436 110456331
Pyuria 17.96 13.41 15 78517 2648 110508119
Injection site bruising 17.87 13.41 7 78525 51256 110459511
Ventricular hypokinesia 17.76 13.41 30 78502 11184 110499583
Pulmonary embolism 17.57 13.41 231 78301 214243 110296524
BRASH syndrome 17.28 13.41 17 78515 3706 110507061
Leg amputation 17.28 13.41 18 78514 4200 110506567
Arrhythmia 17.19 13.41 96 78436 69479 110441288
Blood glucose decreased 17.16 13.41 53 78479 29435 110481332
Systemic lupus erythematosus 17.11 13.41 108 78424 254230 110256537
Vulvovaginal erythema 17.02 13.41 8 78524 509 110510258
Seizure 16.98 13.41 90 78442 221095 110289672
Starvation 16.95 13.41 10 78522 1013 110509754
Scrotal oedema 16.89 13.41 12 78520 1669 110509098
Scrotal cellulitis 16.86 13.41 5 78527 85 110510682
Orthopnoea 16.81 13.41 29 78503 10992 110499775
Urine ketone body 16.66 13.41 6 78526 192 110510575
Type 2 diabetes mellitus 16.64 13.41 67 78465 177165 110333602
Malaise 16.63 13.41 608 77924 671211 109839556
Mitral valve calcification 16.59 13.41 12 78520 1716 110509051
Joint stiffness 16.58 13.41 14 78518 67229 110443538
Left atrial enlargement 16.57 13.41 12 78520 1719 110509048
Dermatitis allergic 16.51 13.41 43 78489 21681 110489086
Tachycardia 16.48 13.41 239 78293 226406 110284361
Gangrene 16.37 13.41 36 78496 16305 110494462
Bulbar palsy 16.33 13.41 7 78525 358 110510409
Injection site swelling 16.33 13.41 12 78520 61778 110448989
Diabetic nephropathy 16.25 13.41 16 78516 3492 110507275
Creatinine urine decreased 16.24 13.41 7 78525 363 110510404
Delirium 16.11 13.41 46 78486 134979 110375788
Peripheral circulatory failure 16.04 13.41 12 78520 1807 110508960
Blood lactic acid increased 16.01 13.41 35 78497 15786 110494981
Diabetic foot 15.93 13.41 17 78515 4078 110506689
Intentional overdose 15.92 13.41 45 78487 132456 110378311
High density lipoprotein decreased 15.91 13.41 20 78512 5713 110505054
Hepatotoxicity 15.88 13.41 13 78519 63387 110447380
Immunodeficiency 15.86 13.41 4 78528 38834 110471933
Haemoconcentration 15.76 13.41 6 78526 225 110510542
Wrong patient 15.76 13.41 11 78521 1488 110509279
Hypertension 15.75 13.41 261 78271 509823 110000944
Blood bicarbonate decreased 15.73 13.41 20 78512 5777 110504990
Off label use 15.67 13.41 889 77643 1499296 109011471
Renal tubular acidosis 15.63 13.41 18 78514 4697 110506070
Urinary tract disorder 15.60 13.41 20 78512 5824 110504943
Dizziness postural 15.57 13.41 33 78499 14576 110496191
Staphylococcal infection 15.55 13.41 16 78516 69928 110440839
Ear infection 15.54 13.41 13 78519 62719 110448048
Blood lactate dehydrogenase increased 15.54 13.41 6 78526 44328 110466439
Oropharyngeal pain 15.48 13.41 47 78485 135229 110375538
Urethral abscess 15.46 13.41 3 78529 6 110510761
Scrotal swelling 15.40 13.41 10 78522 1201 110509566
Coagulopathy 15.26 13.41 5 78527 40906 110469861
Clostridium difficile colitis 15.22 13.41 6 78526 43772 110466995
Osteoporosis 15.16 13.41 24 78508 87128 110423639
Hypertrophy 15.13 13.41 9 78523 926 110509841
Agranulocytosis 15.11 13.41 85 78447 61675 110449092
Conjunctival discolouration 15.09 13.41 5 78527 124 110510643
Intentional self-injury 15.01 13.41 4 78528 37425 110473342
International normalised ratio increased 15.00 13.41 24 78508 86748 110424019
Serotonin syndrome 14.98 13.41 12 78520 59141 110451626
Oxygen saturation decreased 14.95 13.41 59 78473 156923 110353844
Hydrocele 14.88 13.41 10 78522 1271 110509496
Pain in jaw 14.79 13.41 9 78523 51168 110459599
Hypoglycaemic encephalopathy 14.59 13.41 8 78524 705 110510062
Rhinorrhoea 14.57 13.41 32 78500 102634 110408133
Pruritus 14.55 13.41 527 78005 581033 109929734
Dry eye 14.53 13.41 11 78521 55782 110454985
Decreased vibratory sense 14.51 13.41 8 78524 712 110510055
Albuminuria 14.48 13.41 9 78523 1002 110509765
Intentional product use issue 14.47 13.41 252 78280 247654 110263113
Overdose 14.36 13.41 102 78430 233692 110277075
Neurotoxicity 14.33 13.41 6 78526 42201 110468566
Genital tract inflammation 14.22 13.41 5 78527 149 110510618
Sinus rhythm 14.22 13.41 9 78523 1034 110509733
Penile discharge 14.21 13.41 4 78528 56 110510711
Lower urinary tract symptoms 14.15 13.41 7 78525 499 110510268
Inappropriate schedule of product administration 14.13 13.41 213 78319 203424 110307343
Cardiac ventricular thrombosis 13.93 13.41 14 78518 3133 110507634
Renal pain 13.90 13.41 25 78507 9792 110500975
Haemoglobin increased 13.86 13.41 24 78508 9123 110501644
Blood parathyroid hormone increased 13.71 13.41 16 78516 4232 110506535
Gastrointestinal disorder 13.70 13.41 108 78424 241844 110268923
Suicidal ideation 13.56 13.41 29 78503 93908 110416859
Device dislocation 13.47 13.41 3 78529 31701 110479066
Immune-mediated hepatitis 13.45 13.41 20 78512 6691 110504076
Pyrexia 13.43 13.41 512 78020 897753 109613014

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC A10BD15 ALIMENTARY TRACT AND METABOLISM
DRUGS USED IN DIABETES
BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS
Combinations of oral blood glucose lowering drugs
ATC A10BD21 ALIMENTARY TRACT AND METABOLISM
DRUGS USED IN DIABETES
BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS
Combinations of oral blood glucose lowering drugs
ATC A10BD25 ALIMENTARY TRACT AND METABOLISM
DRUGS USED IN DIABETES
BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS
Combinations of oral blood glucose lowering drugs
ATC A10BD29 ALIMENTARY TRACT AND METABOLISM
DRUGS USED IN DIABETES
BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS
Combinations of oral blood glucose lowering drugs
ATC A10BD30 ALIMENTARY TRACT AND METABOLISM
DRUGS USED IN DIABETES
BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS
Combinations of oral blood glucose lowering drugs
ATC A10BD31 ALIMENTARY TRACT AND METABOLISM
DRUGS USED IN DIABETES
BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS
Combinations of oral blood glucose lowering drugs
ATC A10BD32 ALIMENTARY TRACT AND METABOLISM
DRUGS USED IN DIABETES
BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS
Combinations of oral blood glucose lowering drugs
ATC A10BD33 ALIMENTARY TRACT AND METABOLISM
DRUGS USED IN DIABETES
BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS
Combinations of oral blood glucose lowering drugs
ATC A10BK01 ALIMENTARY TRACT AND METABOLISM
DRUGS USED IN DIABETES
BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS
Sodium-glucose co-transporter 2 (SGLT2) inhibitors
ATC C03DA54 CARDIOVASCULAR SYSTEM
DIURETICS
ALDOSTERONE ANTAGONISTS AND OTHER POTASSIUM-SPARING AGENTS
Aldosterone antagonists
MeSH PA D000077203 Sodium-Glucose Transporter 2 Inhibitors
MeSH PA D007004 Hypoglycemic Agents
FDA MoA N0000187058 Sodium-Glucose Transporter 2 Inhibitors
FDA EPC N0000187059 Sodium-Glucose Cotransporter 2 Inhibitor
CHEBI has role CHEBI:22587 antiviral agent
CHEBI has role CHEBI:35469 antidepressant
CHEBI has role CHEBI:35526 hypoglycemic agent
CHEBI has role CHEBI:35554 cardiovascular drug
CHEBI has role CHEBI:35610 antineoplastic agent
CHEBI has role CHEBI:35674 antihypertensive agent
CHEBI has role CHEBI:38070 anti-arrhythmia drug
CHEBI has role CHEBI:50864 insulin-sensitizing drug
CHEBI has role CHEBI:62868 hepatoprotective agent
CHEBI has role CHEBI:67079 anti-inflammatory agent
CHEBI has role CHEBI:73273 sodium-glucose transport protein subtype 2 inhibitor
CHEBI has role CHEBI:74518 anti-obesity agent
CHEBI has role CHEBI:176497 geroprotector
CHEBI has role CHEBI:231911 renoprotective agent

Related Drugs by ATC class:

A10BD Combinations of oral blood glucose lowering drugs 19 drugs
acarbosealogliptincanagliflozinempagliflozinertugliflozinevogliptingemigliptinglimepiridelinagliptinlobeglitazonemetforminphenformin show all 19 →
A10BK Sodium-glucose co-transporter 2 (SGLT2) inhibitors 7 drugs
bexagliflozincanagliflozinempagliflozinertugliflozinipragliflozinluseogliflozinsotagliflozin
C03DA Aldosterone antagonists 5 drugs
canrenoneeplerenonefinerenonepotassium canrenoatespironolactone

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

DiseaseRelationSNOMED_IDDOID
Diabetes mellitus type 2 indication 44054006 DOID:9352
Diabetes mellitus type 1 indication 46635009 DOID:9744
Chronic heart failure indication 48447003
Chronic kidney disease indication 709044004




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 11.62 acidic
pKa2 13.26 acidic
pKa3 13.7 acidic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
10MG FARXIGA ASTRAZENECA AB N202293 Jan. 8, 2014 RX TABLET ORAL 6515117 Oct. 4, 2025 TREATMENT OF TYPE 2 DIABETES MELLITUS
10MG FARXIGA ASTRAZENECA AB N202293 Jan. 8, 2014 RX TABLET ORAL 6515117 Oct. 4, 2025 TREATMENT OF TYPE 2 DIABETES MELLITUS IN COMBINATION WITH EXENATIDE
5MG FARXIGA ASTRAZENECA AB N202293 Jan. 8, 2014 RX TABLET ORAL 6515117 Oct. 4, 2025 TREATMENT OF TYPE 2 DIABETES MELLITUS
5MG FARXIGA ASTRAZENECA AB N202293 Jan. 8, 2014 RX TABLET ORAL 6515117 Oct. 4, 2025 TREATMENT OF TYPE 2 DIABETES MELLITUS IN COMBINATION WITH EXENATIDE
10MG;1GM XIGDUO XR ASTRAZENECA AB N205649 Oct. 29, 2014 RX TABLET, EXTENDED RELEASE ORAL 6515117 Oct. 4, 2025 TREATMENT OF TYPE 2 DIABETES MELLITUS
10MG;500MG XIGDUO XR ASTRAZENECA AB N205649 Oct. 29, 2014 RX TABLET, EXTENDED RELEASE ORAL 6515117 Oct. 4, 2025 TREATMENT OF TYPE 2 DIABETES MELLITUS
2.5MG;1GM XIGDUO XR ASTRAZENECA AB N205649 July 28, 2017 RX TABLET, EXTENDED RELEASE ORAL 6515117 Oct. 4, 2025 TREATMENT OF TYPE 2 DIABETES MELLITUS
5MG;1GM XIGDUO XR ASTRAZENECA AB N205649 Oct. 29, 2014 RX TABLET, EXTENDED RELEASE ORAL 6515117 Oct. 4, 2025 TREATMENT OF TYPE 2 DIABETES MELLITUS
5MG;500MG XIGDUO XR ASTRAZENECA AB N205649 Oct. 29, 2014 RX TABLET, EXTENDED RELEASE ORAL 6515117 Oct. 4, 2025 TREATMENT OF TYPE 2 DIABETES MELLITUS
10MG;EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** QTERN ASTRAZENECA AB N209091 Feb. 27, 2017 DISCN TABLET ORAL 6515117 Oct. 4, 2025 TREATMENT OF TYPE 2 DIABETES MELLITUS
5MG;EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** QTERN ASTRAZENECA AB N209091 May 2, 2019 DISCN TABLET ORAL 6515117 Oct. 4, 2025 TREATMENT OF TYPE 2 DIABETES MELLITUS
10MG;1GM;EQ 5MG BASE QTERNMET XR ASTRAZENECA AB N210874 May 2, 2019 DISCN TABLET, EXTENDED RELEASE ORAL 6515117 Oct. 4, 2025 TREATMENT OF TYPE 2 DIABETES MELLITUS
2.5MG;1GM;EQ 2.5MG BASE QTERNMET XR ASTRAZENECA AB N210874 May 2, 2019 DISCN TABLET, EXTENDED RELEASE ORAL 6515117 Oct. 4, 2025 TREATMENT OF TYPE 2 DIABETES MELLITUS
5MG;1GM;EQ 2.5MG BASE QTERNMET XR ASTRAZENECA AB N210874 May 2, 2019 DISCN TABLET, EXTENDED RELEASE ORAL 6515117 Oct. 4, 2025 TREATMENT OF TYPE 2 DIABETES MELLITUS
5MG;1GM;EQ 5MG BASE QTERNMET XR ASTRAZENECA AB N210874 May 2, 2019 DISCN TABLET, EXTENDED RELEASE ORAL 6515117 Oct. 4, 2025 TREATMENT OF TYPE 2 DIABETES MELLITUS
10MG FARXIGA ASTRAZENECA AB N202293 Jan. 8, 2014 RX TABLET ORAL 8329648 Aug. 18, 2026 REDUCING FASTING PLASMA GLUCOSE IN A HUMAN IN NEED THEREOF IN COMBINATION WITH A SUSTAINED-RELEASE COMPOSITION CONTAINING EXENDIN-4
10MG FARXIGA ASTRAZENECA AB N202293 Jan. 8, 2014 RX TABLET ORAL 8329648 Aug. 18, 2026 REDUCING HBA1C IN A HUMAN IN NEED THEREOF IN COMBINATION WITH A SUSTAINED-RELEASE COMPOSITION CONTAINING EXENDIN-4
10MG FARXIGA ASTRAZENECA AB N202293 Jan. 8, 2014 RX TABLET ORAL 8329648 Aug. 18, 2026 TREATMENT OF TYPE 2 DIABETES MELLITUS IN COMBINATION WITH EXENATIDE
10MG FARXIGA ASTRAZENECA AB N202293 Jan. 8, 2014 RX TABLET ORAL 8906851 Aug. 18, 2026 TREATMENT OF TYPE 2 DIABETES MELLITUS IN COMBINATION WITH EXENATIDE
5MG FARXIGA ASTRAZENECA AB N202293 Jan. 8, 2014 RX TABLET ORAL 8329648 Aug. 18, 2026 REDUCING FASTING PLASMA GLUCOSE IN A HUMAN IN NEED THEREOF IN COMBINATION WITH A SUSTAINED-RELEASE COMPOSITION CONTAINING EXENDIN-4
5MG FARXIGA ASTRAZENECA AB N202293 Jan. 8, 2014 RX TABLET ORAL 8329648 Aug. 18, 2026 REDUCING HBA1C IN A HUMAN IN NEED THEREOF IN COMBINATION WITH A SUSTAINED-RELEASE COMPOSITION CONTAINING EXENDIN-4
5MG FARXIGA ASTRAZENECA AB N202293 Jan. 8, 2014 RX TABLET ORAL 8329648 Aug. 18, 2026 TREATMENT OF TYPE 2 DIABETES MELLITUS IN COMBINATION WITH EXENATIDE
5MG FARXIGA ASTRAZENECA AB N202293 Jan. 8, 2014 RX TABLET ORAL 8906851 Aug. 18, 2026 TREATMENT OF TYPE 2 DIABETES MELLITUS IN COMBINATION WITH EXENATIDE
10MG FARXIGA ASTRAZENECA AB N202293 Jan. 8, 2014 RX TABLET ORAL 8501698 June 20, 2027 TREATMENT OF TYPE 2 DIABETES MELLITUS
5MG FARXIGA ASTRAZENECA AB N202293 Jan. 8, 2014 RX TABLET ORAL 8501698 June 20, 2027 TREATMENT OF TYPE 2 DIABETES MELLITUS
10MG;1GM XIGDUO XR ASTRAZENECA AB N205649 Oct. 29, 2014 RX TABLET, EXTENDED RELEASE ORAL 8501698 June 20, 2027 TREATMENT OF TYPE 2 DIABETES MELLITUS
10MG;500MG XIGDUO XR ASTRAZENECA AB N205649 Oct. 29, 2014 RX TABLET, EXTENDED RELEASE ORAL 8501698 June 20, 2027 TREATMENT OF TYPE 2 DIABETES MELLITUS
2.5MG;1GM XIGDUO XR ASTRAZENECA AB N205649 July 28, 2017 RX TABLET, EXTENDED RELEASE ORAL 8501698 June 20, 2027 TREATMENT OF TYPE 2 DIABETES MELLITUS
5MG;1GM XIGDUO XR ASTRAZENECA AB N205649 Oct. 29, 2014 RX TABLET, EXTENDED RELEASE ORAL 8501698 June 20, 2027 TREATMENT OF TYPE 2 DIABETES MELLITUS
5MG;500MG XIGDUO XR ASTRAZENECA AB N205649 Oct. 29, 2014 RX TABLET, EXTENDED RELEASE ORAL 8501698 June 20, 2027 TREATMENT OF TYPE 2 DIABETES MELLITUS
10MG;EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** QTERN ASTRAZENECA AB N209091 Feb. 27, 2017 DISCN TABLET ORAL 8501698 June 20, 2027 METHOD FOR TREATING TYPE 2 DIABETES MELLITUS (T2DM) IN PATIENTS WHO ARE ALREADY TREATED WITH DAPAGLIFLOZIN AND SAXAGLIPTIN
10MG;EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** QTERN ASTRAZENECA AB N209091 Feb. 27, 2017 DISCN TABLET ORAL 8501698 June 20, 2027 METHOD FOR TREATING TYPE 2 DIABETES MELLITUS (T2DM) IN PATIENTS WHO HAVE INADEQUATE CONTROL WITH DAPAGLIFLOZIN
10MG;EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** QTERN ASTRAZENECA AB N209091 Feb. 27, 2017 DISCN TABLET ORAL 8501698 June 20, 2027 TREATMENT OF TYPE 2 DIABETES MELLITUS
5MG;EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** QTERN ASTRAZENECA AB N209091 May 2, 2019 DISCN TABLET ORAL 8501698 June 20, 2027 TREATMENT OF TYPE 2 DIABETES MELLITUS
10MG;1GM;EQ 5MG BASE QTERNMET XR ASTRAZENECA AB N210874 May 2, 2019 DISCN TABLET, EXTENDED RELEASE ORAL 8501698 June 20, 2027 TREATMENT OF TYPE 2 DIABETES MELLITUS
2.5MG;1GM;EQ 2.5MG BASE QTERNMET XR ASTRAZENECA AB N210874 May 2, 2019 DISCN TABLET, EXTENDED RELEASE ORAL 8501698 June 20, 2027 TREATMENT OF TYPE 2 DIABETES MELLITUS
5MG;1GM;EQ 2.5MG BASE QTERNMET XR ASTRAZENECA AB N210874 May 2, 2019 DISCN TABLET, EXTENDED RELEASE ORAL 8501698 June 20, 2027 TREATMENT OF TYPE 2 DIABETES MELLITUS
5MG;1GM;EQ 5MG BASE QTERNMET XR ASTRAZENECA AB N210874 May 2, 2019 DISCN TABLET, EXTENDED RELEASE ORAL 8501698 June 20, 2027 TREATMENT OF TYPE 2 DIABETES MELLITUS
10MG FARXIGA ASTRAZENECA AB N202293 Jan. 8, 2014 RX TABLET ORAL 8361972 March 21, 2028 TREATMENT OF TYPE 2 DIABETES MELLITUS
10MG FARXIGA ASTRAZENECA AB N202293 Jan. 8, 2014 RX TABLET ORAL 8361972 March 21, 2028 TREATMENT OF TYPE 2 DIABETES MELLITUS IN COMBINATION WITH EXENATIDE
5MG FARXIGA ASTRAZENECA AB N202293 Jan. 8, 2014 RX TABLET ORAL 8361972 March 21, 2028 TREATMENT OF TYPE 2 DIABETES MELLITUS
5MG FARXIGA ASTRAZENECA AB N202293 Jan. 8, 2014 RX TABLET ORAL 8361972 March 21, 2028 TREATMENT OF TYPE 2 DIABETES MELLITUS IN COMBINATION WITH EXENATIDE
10MG;EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** QTERN ASTRAZENECA AB N209091 Feb. 27, 2017 DISCN TABLET ORAL 8361972 March 21, 2028 METHOD FOR TREATING TYPE 2 DIABETES MELLITUS (T2DM) IN PATIENTS WHO ARE ALREADY TREATED WITH DAPAGLIFLOZIN AND SAXAGLIPTIN
10MG;EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** QTERN ASTRAZENECA AB N209091 Feb. 27, 2017 DISCN TABLET ORAL 8361972 March 21, 2028 METHOD FOR TREATING TYPE 2 DIABETES MELLITUS (T2DM) IN PATIENTS WHO HAVE INADEQUATE CONTROL WITH DAPAGLIFLOZIN
10MG;EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** QTERN ASTRAZENECA AB N209091 Feb. 27, 2017 DISCN TABLET ORAL 8361972 March 21, 2028 TREATMENT OF TYPE 2 DIABETES MELLITUS
5MG;EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** QTERN ASTRAZENECA AB N209091 May 2, 2019 DISCN TABLET ORAL 8361972 March 21, 2028 TREATMENT OF TYPE 2 DIABETES MELLITUS
10MG FARXIGA ASTRAZENECA AB N202293 Jan. 8, 2014 RX TABLET ORAL 8685934 May 26, 2030 TREATMENT OF TYPE 2 DIABETES MELLITUS IN A PATIENT, WHEREIN GLYCEMIC CONTROL (HBA1C < 7.0%) IS NOT ACHIEVABLE USING ONE OR MORE OF INSULIN, METFORMIN, PIOGLITAZONE, OR ROSIGLITAZONE
5MG FARXIGA ASTRAZENECA AB N202293 Jan. 8, 2014 RX TABLET ORAL 8685934 May 26, 2030 TREATMENT OF TYPE 2 DIABETES MELLITUS IN A PATIENT, WHEREIN GLYCEMIC CONTROL (HBA1C < 7.0%) IS NOT ACHIEVABLE USING ONE OR MORE OF INSULIN, METFORMIN, PIOGLITAZONE, OR ROSIGLITAZONE
10MG;1GM XIGDUO XR ASTRAZENECA AB N205649 Oct. 29, 2014 RX TABLET, EXTENDED RELEASE ORAL 8685934 May 26, 2030 TREATMENT OF TYPE 2 DIABETES MELLITUS IN A PATIENT, WHEREIN GLYCEMIC CONTROL (HBA1C < 7.0%) IS NOT ACHIEVABLE USING ONE OR MORE OF INSULIN, METFORMIN, PIOGLITAZONE, OR ROSIGLITAZONE
10MG;500MG XIGDUO XR ASTRAZENECA AB N205649 Oct. 29, 2014 RX TABLET, EXTENDED RELEASE ORAL 8685934 May 26, 2030 TREATMENT OF TYPE 2 DIABETES MELLITUS IN A PATIENT, WHEREIN GLYCEMIC CONTROL (HBA1C < 7.0%) IS NOT ACHIEVABLE USING ONE OR MORE OF INSULIN, METFORMIN, PIOGLITAZONE, OR ROSIGLITAZONE
2.5MG;1GM XIGDUO XR ASTRAZENECA AB N205649 July 28, 2017 RX TABLET, EXTENDED RELEASE ORAL 8685934 May 26, 2030 TREATMENT OF TYPE 2 DIABETES MELLITUS IN A PATIENT, WHEREIN GLYCEMIC CONTROL (HBA1C < 7.0%) IS NOT ACHIEVABLE USING ONE OR MORE OF INSULIN, METFORMIN, PIOGLITAZONE, OR ROSIGLITAZONE
5MG;1GM XIGDUO XR ASTRAZENECA AB N205649 Oct. 29, 2014 RX TABLET, EXTENDED RELEASE ORAL 8685934 May 26, 2030 TREATMENT OF TYPE 2 DIABETES MELLITUS IN A PATIENT, WHEREIN GLYCEMIC CONTROL (HBA1C < 7.0%) IS NOT ACHIEVABLE USING ONE OR MORE OF INSULIN, METFORMIN, PIOGLITAZONE, OR ROSIGLITAZONE
5MG;500MG XIGDUO XR ASTRAZENECA AB N205649 Oct. 29, 2014 RX TABLET, EXTENDED RELEASE ORAL 8685934 May 26, 2030 TREATMENT OF TYPE 2 DIABETES MELLITUS IN A PATIENT, WHEREIN GLYCEMIC CONTROL (HBA1C < 7.0%) IS NOT ACHIEVABLE USING ONE OR MORE OF INSULIN, METFORMIN, PIOGLITAZONE, OR ROSIGLITAZONE
10MG FARXIGA ASTRAZENECA AB N202293 Jan. 8, 2014 RX TABLET ORAL 11826376 July 18, 2039 REDUCE THE RISK OF CARDIOVASCULAR DEATH AND HOSPITALIZATION FOR HEART FAILURE AND URGENT HEART FAILURE VISITS IN ADULTS WITH HEART FAILURE WITH PRESERVED EJECTION FRACTION AND WITHOUT TYPE II DIABETES
10MG FARXIGA ASTRAZENECA AB N202293 Jan. 8, 2014 RX TABLET ORAL 12472194 July 18, 2039 REDUCE THE RISK OF CARDIOVASCULAR DEATH AND HOSPITALIZATION FOR HEART FAILURE AND URGENT HEART FAILURE VISITS IN ADULTS WITH HEART FAILURE WITH PRESERVED EJECTION FRACTION AND STRUCTURAL HEART DISEASE AND WITHOUT TYPE II DIABETES
10MG FARXIGA ASTRAZENECA AB N202293 Jan. 8, 2014 RX TABLET ORAL 10973836 March 9, 2040 REDUCTION OF THE RISK OF CARDIOVASCULAR DEATH AND HOSPITALIZATION FOR HEART FAILURE IN ADULTS WITH HEART FAILURE WITH REDUCED EJECTION FRACTION AND WITHOUT TYPE II DIABETES
10MG FARXIGA ASTRAZENECA AB N202293 Jan. 8, 2014 RX TABLET ORAL 11903955 March 9, 2040 REDUCE THE RISK OF CARDIOVASCULAR DEATH AND WORSENING HEART FAILURE IN ADULTS WITH HEART FAILURE WITH REDUCED EJECTION FRACTION, WITHOUT TYPE II DIABETES, AND HAVING AN HBA1C OF < 5.7%
10MG FARXIGA ASTRAZENECA AB N202293 Jan. 8, 2014 RX TABLET ORAL 12213988 April 1, 2041 REDUCING THE RISK OF SUSTAINED EGFR DECLINE, END-STAGE KIDNEY DISEASE, CV DEATH, AND HOSPITALIZATION FOR HEART FAILURE IN ADULTS WITH CKD AT RISK OF PROGRESSION AND WITHOUT TYPE II DIABETES AFTER AT LEAST 4 MONTHS OF TREATMENT
10MG FARXIGA ASTRAZENECA AB N202293 Jan. 8, 2014 RX TABLET ORAL 12409186 April 1, 2041 REDUCING THE RISK OF SUSTAINED EGFR DECLINE, END-STAGE KIDNEY DISEASE, CV DEATH, AND HOSPITALIZATION FOR HEART FAILURE IN ADULTS WITH CKD AT RISK OF PROGRESSION AND WITHOUT TYPE II DIABETES AFTER AT LEAST 4 MONTHS OF TREATMENT

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
10MG FARXIGA ASTRAZENECA AB N202293 Jan. 8, 2014 RX TABLET ORAL May 8, 2026 LABELING REVISIONS RELATED TO STUDY D1699CC00001
5MG FARXIGA ASTRAZENECA AB N202293 Jan. 8, 2014 RX TABLET ORAL May 8, 2026 LABELING REVISIONS RELATED TO STUDY D1699CC00001
10MG DAPAGLIFLOZIN INVENTIA A211156 April 6, 2026 RX TABLET ORAL Oct. 3, 2026 PATENT CHALLENGE
5MG DAPAGLIFLOZIN INVENTIA A211156 April 6, 2026 RX TABLET ORAL Oct. 3, 2026 PATENT CHALLENGE
10MG DAPAGLIFLOZIN SANDOZ A211312 April 6, 2026 RX TABLET ORAL Oct. 3, 2026 PATENT CHALLENGE
5MG DAPAGLIFLOZIN SANDOZ A211312 April 6, 2026 RX TABLET ORAL Oct. 3, 2026 PATENT CHALLENGE
10MG DAPAGLIFLOZIN MICRO LABS A211467 April 6, 2026 RX TABLET ORAL Oct. 3, 2026 PATENT CHALLENGE
5MG DAPAGLIFLOZIN MICRO LABS A211467 April 6, 2026 RX TABLET ORAL Oct. 3, 2026 PATENT CHALLENGE
10MG DAPAGLIFLOZIN BIOCON PHARMA A211470 April 6, 2026 RX TABLET ORAL Oct. 3, 2026 PATENT CHALLENGE
5MG DAPAGLIFLOZIN BIOCON PHARMA A211470 April 6, 2026 RX TABLET ORAL Oct. 3, 2026 PATENT CHALLENGE
10MG;1GM DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE MSN A211479 April 6, 2026 RX TABLET, EXTENDED RELEASE ORAL Oct. 3, 2026 PATENT CHALLENGE
10MG;500MG DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE MSN A211479 April 6, 2026 RX TABLET, EXTENDED RELEASE ORAL Oct. 3, 2026 PATENT CHALLENGE
5MG;1GM DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE MSN A211479 April 6, 2026 RX TABLET, EXTENDED RELEASE ORAL Oct. 3, 2026 PATENT CHALLENGE
5MG;500MG DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE MSN A211479 April 6, 2026 RX TABLET, EXTENDED RELEASE ORAL Oct. 3, 2026 PATENT CHALLENGE
10MG DAPAGLIFLOZIN AJANTA PHARMA LTD A211482 April 6, 2026 RX TABLET ORAL Oct. 3, 2026 PATENT CHALLENGE
5MG DAPAGLIFLOZIN AJANTA PHARMA LTD A211482 April 6, 2026 RX TABLET ORAL Oct. 3, 2026 PATENT CHALLENGE
10MG;1GM DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE SUN PHARM A211491 April 6, 2026 RX TABLET, EXTENDED RELEASE ORAL Oct. 3, 2026 PATENT CHALLENGE
10MG;500MG DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE SUN PHARM A211491 April 6, 2026 RX TABLET, EXTENDED RELEASE ORAL Oct. 3, 2026 PATENT CHALLENGE
5MG;1GM DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE SUN PHARM A211491 April 6, 2026 RX TABLET, EXTENDED RELEASE ORAL Oct. 3, 2026 PATENT CHALLENGE
10MG DAPAGLIFLOZIN AIZANT A211523 April 6, 2026 RX TABLET ORAL Oct. 3, 2026 PATENT CHALLENGE
5MG DAPAGLIFLOZIN AIZANT A211523 April 6, 2026 RX TABLET ORAL Oct. 3, 2026 PATENT CHALLENGE
10MG DAPAGLIFLOZIN TEVA PHARMS USA A211541 April 6, 2026 RX TABLET ORAL Oct. 3, 2026 PATENT CHALLENGE
5MG DAPAGLIFLOZIN TEVA PHARMS USA A211541 April 6, 2026 RX TABLET ORAL Oct. 3, 2026 PATENT CHALLENGE
10MG DAPAGLIFLOZIN ALKEM LABS LTD A211545 April 6, 2026 RX TABLET ORAL Oct. 3, 2026 PATENT CHALLENGE
5MG DAPAGLIFLOZIN ALKEM LABS LTD A211545 April 6, 2026 RX TABLET ORAL Oct. 3, 2026 PATENT CHALLENGE
10MG DAPAGLIFLOZIN ALEMBIC A211560 April 6, 2026 RX TABLET ORAL Oct. 3, 2026 PATENT CHALLENGE
5MG DAPAGLIFLOZIN ALEMBIC A211560 April 6, 2026 RX TABLET ORAL Oct. 3, 2026 PATENT CHALLENGE
10MG;1GM DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE ALKEM LABS LTD A211563 April 6, 2026 RX TABLET, EXTENDED RELEASE ORAL Oct. 3, 2026 PATENT CHALLENGE
10MG;500MG DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE ALKEM LABS LTD A211563 April 6, 2026 RX TABLET, EXTENDED RELEASE ORAL Oct. 3, 2026 PATENT CHALLENGE
5MG;1GM DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE ALKEM LABS LTD A211563 April 6, 2026 RX TABLET, EXTENDED RELEASE ORAL Oct. 3, 2026 PATENT CHALLENGE
5MG;500MG DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE ALKEM LABS LTD A211563 April 6, 2026 RX TABLET, EXTENDED RELEASE ORAL Oct. 3, 2026 PATENT CHALLENGE
10MG FARXIGA ASTRAZENECA AB N202293 Jan. 8, 2014 RX TABLET ORAL Nov. 8, 2026 PEDIATRIC EXCLUSIVITY
5MG FARXIGA ASTRAZENECA AB N202293 Jan. 8, 2014 RX TABLET ORAL Nov. 8, 2026 PEDIATRIC EXCLUSIVITY
10MG FARXIGA ASTRAZENECA AB N202293 Jan. 8, 2014 RX TABLET ORAL June 12, 2027 NEW PATIENT POPULATION
5MG FARXIGA ASTRAZENECA AB N202293 Jan. 8, 2014 RX TABLET ORAL June 12, 2027 NEW PATIENT POPULATION
10MG;1GM XIGDUO XR ASTRAZENECA AB N205649 Oct. 29, 2014 RX TABLET, EXTENDED RELEASE ORAL June 12, 2027 NEW PATIENT POPULATION
10MG;500MG XIGDUO XR ASTRAZENECA AB N205649 Oct. 29, 2014 RX TABLET, EXTENDED RELEASE ORAL June 12, 2027 NEW PATIENT POPULATION
2.5MG;1GM XIGDUO XR ASTRAZENECA AB N205649 July 28, 2017 RX TABLET, EXTENDED RELEASE ORAL June 12, 2027 NEW PATIENT POPULATION
5MG;1GM XIGDUO XR ASTRAZENECA AB N205649 Oct. 29, 2014 RX TABLET, EXTENDED RELEASE ORAL June 12, 2027 NEW PATIENT POPULATION
5MG;500MG XIGDUO XR ASTRAZENECA AB N205649 Oct. 29, 2014 RX TABLET, EXTENDED RELEASE ORAL June 12, 2027 NEW PATIENT POPULATION
10MG FARXIGA ASTRAZENECA AB N202293 Jan. 8, 2014 RX TABLET ORAL Dec. 12, 2027 PEDIATRIC EXCLUSIVITY
5MG FARXIGA ASTRAZENECA AB N202293 Jan. 8, 2014 RX TABLET ORAL Dec. 12, 2027 PEDIATRIC EXCLUSIVITY
10MG;1GM XIGDUO XR ASTRAZENECA AB N205649 Oct. 29, 2014 RX TABLET, EXTENDED RELEASE ORAL Dec. 12, 2027 PEDIATRIC EXCLUSIVITY
10MG;500MG XIGDUO XR ASTRAZENECA AB N205649 Oct. 29, 2014 RX TABLET, EXTENDED RELEASE ORAL Dec. 12, 2027 PEDIATRIC EXCLUSIVITY
2.5MG;1GM XIGDUO XR ASTRAZENECA AB N205649 July 28, 2017 RX TABLET, EXTENDED RELEASE ORAL Dec. 12, 2027 PEDIATRIC EXCLUSIVITY
5MG;1GM XIGDUO XR ASTRAZENECA AB N205649 Oct. 29, 2014 RX TABLET, EXTENDED RELEASE ORAL Dec. 12, 2027 PEDIATRIC EXCLUSIVITY
5MG;500MG XIGDUO XR ASTRAZENECA AB N205649 Oct. 29, 2014 RX TABLET, EXTENDED RELEASE ORAL Dec. 12, 2027 PEDIATRIC EXCLUSIVITY

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])		Mechanism
action		Bioact sourceMoA source
Sodium/glucose cotransporter 2 Transporter INHIBITOR IC50 9.30 IUPHAR IUPHAR
Sodium/glucose cotransporter 1 Transporter IC50 8.49 CHEMBL
Sodium/myo-inositol cotransporter 2 Transporter IC50 6.42 CHEMBL
Low affinity sodium-glucose cotransporter Transporter IC50 8.87 CHEMBL
Potassium channel subfamily K member 7 Ion channel ACTIVATOR EC50 4 IUPHAR
Sodium/glucose cotransporter 2 Transporter EC50 8.52 CHEMBL

External reference:

IDSource
D08897 KEGG_DRUG
960404-48-2 SECONDARY_CAS_RN
4033035 VANDF
CHEBI:85078 CHEBI
LE6 PDB_CHEM_ID
CHEMBL429910 ChEMBL_ID
CHEMBL2103802 ChEMBL_ID
C529054 MESH_SUPPLEMENTAL_RECORD_UI
4594 IUPHAR_LIGAND_ID
DB06292 DRUGBANK_ID
1486966 RXNORM
210769 MMSL
28989 MMSL
29986 MMSL
376980 MMSL
d07928 MMSL
014949 NDDF
014950 NDDF
703674001 SNOMEDCT_US
703675000 SNOMEDCT_US
703678003 SNOMEDCT_US
783086004 SNOMEDCT_US
C2353951 UMLSCUI
8886 INN_ID
9887712 PUBCHEM_CID
1ULL0QJ8UC UNII

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
FARXIGA HUMAN PRESCRIPTION DRUG LABEL 1 0310-6205 TABLET, FILM COATED 5 mg ORAL NDA 27 sections
FARXIGA HUMAN PRESCRIPTION DRUG LABEL 1 0310-6210 TABLET, FILM COATED 10 mg ORAL NDA 27 sections
XIGDUOXR HUMAN PRESCRIPTION DRUG LABEL 2 0310-6225 TABLET, FILM COATED, EXTENDED RELEASE 2.50 mg ORAL NDA 29 sections
XIGDUOXR HUMAN PRESCRIPTION DRUG LABEL 2 0310-6250 TABLET, FILM COATED, EXTENDED RELEASE 5 mg ORAL NDA 29 sections
XIGDUOXR HUMAN PRESCRIPTION DRUG LABEL 2 0310-6260 TABLET, FILM COATED, EXTENDED RELEASE 5 mg ORAL NDA 29 sections
XIGDUOXR HUMAN PRESCRIPTION DRUG LABEL 2 0310-6270 TABLET, FILM COATED, EXTENDED RELEASE 10 mg ORAL NDA 29 sections
XIGDUOXR HUMAN PRESCRIPTION DRUG LABEL 2 0310-6280 TABLET, FILM COATED, EXTENDED RELEASE 10 mg ORAL NDA 29 sections
DAPAGLIFLOZIN HUMAN PRESCRIPTION DRUG LABEL 1 0480-3527 TABLET, FILM COATED 5 mg ORAL ANDA 26 sections
DAPAGLIFLOZIN HUMAN PRESCRIPTION DRUG LABEL 1 0480-3528 TABLET, FILM COATED 10 mg ORAL ANDA 26 sections
Dapagliflozin HUMAN PRESCRIPTION DRUG LABEL 1 0781-5985 TABLET, FILM COATED 5 mg ORAL ANDA 26 sections
Dapagliflozin HUMAN PRESCRIPTION DRUG LABEL 1 0781-5990 TABLET, FILM COATED 10 mg ORAL ANDA 26 sections
Dapagliflozin Human Prescription Drug Label 1 27241-151 TABLET 5 mg ORAL ANDA 26 sections
Dapagliflozin Human Prescription Drug Label 1 27241-152 TABLET 10 mg ORAL ANDA 26 sections
Dapagliflozin and Metformin Hydrochloride Human Prescription Drug Label 2 33342-406 TABLET, EXTENDED RELEASE 5 mg ORAL ANDA 27 sections
Dapagliflozin and Metformin Hydrochloride Human Prescription Drug Label 2 33342-407 TABLET, EXTENDED RELEASE 10 mg ORAL ANDA 27 sections
Dapagliflozin and Metformin Hydrochloride Human Prescription Drug Label 2 33342-408 TABLET, EXTENDED RELEASE 5 mg ORAL ANDA 27 sections
Dapagliflozin and Metformin Hydrochloride Human Prescription Drug Label 2 33342-409 TABLET, EXTENDED RELEASE 10 mg ORAL ANDA 27 sections
dapagliflozin Human Prescription Drug Label 1 33342-585 TABLET 5 mg ORAL ANDA 26 sections
dapagliflozin Human Prescription Drug Label 1 33342-586 TABLET 10 mg ORAL ANDA 26 sections
DAPAGLIFLOZIN Human Prescription Drug Label 1 46708-392 TABLET, FILM COATED 5 mg ORAL ANDA 26 sections
DAPAGLIFLOZIN Human Prescription Drug Label 1 46708-393 TABLET, FILM COATED 10 mg ORAL ANDA 26 sections
FARXIGA HUMAN PRESCRIPTION DRUG LABEL 1 50090-3481 TABLET, FILM COATED 10 mg ORAL NDA 27 sections
FARXIGA HUMAN PRESCRIPTION DRUG LABEL 1 50090-3482 TABLET, FILM COATED 5 mg ORAL NDA 27 sections
DAPAGLIFLOZIN HUMAN PRESCRIPTION DRUG LABEL 1 50090-7056 TABLET, FILM COATED 5 mg ORAL NDA authorized generic 27 sections
DAPAGLIFLOZIN HUMAN PRESCRIPTION DRUG LABEL 1 50090-7057 TABLET, FILM COATED 10 mg ORAL NDA authorized generic 27 sections
Dapagliflozin Human Prescription Drug Label 1 50090-7971 TABLET, FILM COATED 5 mg ORAL ANDA 25 sections
Dapagliflozin Human Prescription Drug Label 1 50090-7972 TABLET, FILM COATED 10 mg ORAL ANDA 25 sections
FARXIGA HUMAN PRESCRIPTION DRUG LABEL 1 55154-6932 TABLET, FILM COATED 5 mg ORAL NDA 27 sections
FARXIGA HUMAN PRESCRIPTION DRUG LABEL 1 55154-6933 TABLET, FILM COATED 10 mg ORAL NDA 27 sections
Dapagliflozin and Metformin hydrochloride Human Prescription Drug Label 2 59651-154 TABLET, FILM COATED, EXTENDED RELEASE 5 mg ORAL ANDA 29 sections