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

Stem definitionDrug idCAS RN
steroids, progestogens 1110 54048-10-1

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • etonogestrel
  • implanon
  • 3-Oxodesogestrel
metabolite of DESOGESTREL; structure given in first source; Implanon: implant containing etonogestrel (3-keto-desogestrel)
  • Molecular weight: 324.46
  • Formula: C22H28O2
  • CLOGP: 3.35
  • LIPINSKI: 0
  • HAC: 2
  • HDO: 1
  • TPSA: 37.30
  • ALOGS: -4.64
  • ROTB: 1

  • Status: OFP

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

Drug dosage:

DoseUnitRoute
68 mcg s.c. implant

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 1 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 0.51 mg/mL Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 0.10 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 0.01 ┬ÁM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 76 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution) 2.87 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 2 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.02 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 25 hours Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
Oct. 3, 2001 FDA

FDA Adverse Event Reporting System (Female)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
No adverse event 19273.96 23.62 5582 86556 33683 53223245
Complication associated with device 14992.31 23.62 3803 88335 12362 53244566
Incorrect product administration duration 12101.54 23.62 2950 89188 7674 53249254
Device difficult to use 12016.52 23.62 2919 89219 7440 53249488
Device breakage 11765.03 23.62 2881 89257 7686 53249242
Product quality issue 10219.19 23.62 3396 88742 33627 53223301
Device deployment issue 10015.36 23.62 2082 90056 1582 53255346
Complication of device insertion 7687.47 23.62 1835 90303 4182 53252746
Complication of device removal 7448.19 23.62 1671 90467 2511 53254417
Unintended pregnancy 7232.52 23.62 1749 90389 4304 53252624
Implant site pain 6768.09 23.62 1393 90745 934 53255994
Pregnancy with implant contraceptive 6698.54 23.62 1379 90759 927 53256001
Device kink 5491.76 23.62 1149 90989 926 53256002
Heavy menstrual bleeding 5342.05 23.62 1733 90405 15643 53241285
Menstruation irregular 5167.20 23.62 1380 90758 5686 53251242
Device dislocation 4713.21 23.62 1704 90434 21893 53235035
Intermenstrual bleeding 4648.39 23.62 1328 90810 7370 53249558
Device expulsion 3924.85 23.62 1589 90549 28224 53228704
Amenorrhoea 3197.19 23.62 1012 91126 8337 53248591
Vaginal haemorrhage 2438.96 23.62 1101 91037 25740 53231188
Implant site erythema 1812.69 23.62 362 91776 156 53256772
Implant site pruritus 1771.41 23.62 360 91778 202 53256726
Implant site bruising 1300.08 23.62 254 91884 71 53256857
Device placement issue 1190.67 23.62 272 91866 460 53256468
Implant site swelling 1169.95 23.62 251 91887 257 53256671
Implant site infection 1112.15 23.62 273 91865 724 53256204
Implant site scar 1058.23 23.62 205 91933 46 53256882
Inappropriate schedule of product administration 1055.48 23.62 939 91199 73939 53182989
Implant site fibrosis 1005.69 23.62 190 91948 14 53256914
General anaesthesia 978.75 23.62 186 91952 20 53256908
Menstruation delayed 951.20 23.62 268 91870 1393 53255535
Menstrual disorder 905.26 23.62 329 91809 4261 53252667
Dysmenorrhoea 830.77 23.62 294 91844 3507 53253421
Mood swings 791.39 23.62 448 91690 17038 53239890
Abortion spontaneous 781.27 23.62 646 91492 45989 53210939
Medical device site discomfort 771.11 23.62 167 91971 186 53256742
Drug ineffective 750.20 23.62 242 91896 817003 52439925
Menometrorrhagia 732.74 23.62 194 91944 761 53256167
Medical device removal 720.77 23.62 206 91932 1137 53255791
Pulmonary embolism 715.53 23.62 933 91205 113509 53143419
Implant site irritation 714.76 23.62 138 92000 28 53256900
Adverse event 696.51 23.62 573 91565 40488 53216440
Abortion induced 677.09 23.62 344 91794 10482 53246446
Diarrhoea 659.13 23.62 140 91998 625406 52631522
Polymenorrhoea 632.57 23.62 183 91955 1062 53255866
Weight increased 623.29 23.62 1199 90939 203368 53053560
Pregnancy with contraceptive device 610.80 23.62 249 91889 4472 53252456
Hypomenorrhoea 590.75 23.62 145 91993 384 53256544
Device issue 553.00 23.62 386 91752 21272 53235656
Menstruation normal 543.98 23.62 115 92023 102 53256826
Death 530.33 23.62 20 92118 357212 52899716
Implant site rash 507.16 23.62 102 92036 49 53256879
Device embolisation 482.72 23.62 90 92048 0 53256928
Implant site reaction 465.97 23.62 96 92042 64 53256864
Rheumatoid arthritis 455.39 23.62 21 92117 314510 52942418
Pneumonia 424.10 23.62 93 92045 407076 52849852
Dyspnoea 423.06 23.62 245 91893 585987 52670941
Implant site hypoaesthesia 410.05 23.62 77 92061 3 53256925
Oligomenorrhoea 399.15 23.62 114 92024 627 53256301
Fatigue 397.05 23.62 408 91730 730098 52526830
Pyrexia 390.83 23.62 107 92031 403086 52853842
Deep vein thrombosis 378.35 23.62 582 91556 82331 53174597
Implant site haemorrhage 367.78 23.62 72 92066 21 53256907
Fall 362.88 23.62 87 92051 358353 52898575
Toxicity to various agents 353.38 23.62 5 92133 219593 53037335
Acute kidney injury 339.92 23.62 26 92112 253842 53003086
Expired product administered 333.61 23.62 175 91963 5701 53251227
Medical device discomfort 330.10 23.62 128 92010 2002 53254926
Implant site cellulitis 329.61 23.62 62 92076 3 53256925
Vaginal discharge 322.82 23.62 170 91968 5583 53251345
Abnormal withdrawal bleeding 322.75 23.62 76 92062 157 53256771
Implant site paraesthesia 321.80 23.62 60 92078 0 53256928
Arthralgia 319.34 23.62 182 91956 439601 52817327
Off label use 310.55 23.62 219 91919 471993 52784935
Implant site mass 304.71 23.62 59 92079 13 53256915
Acne 304.15 23.62 271 91867 21315 53235613
Condition aggravated 302.81 23.62 71 92067 297063 52959865
Surgery 297.92 23.62 320 91818 31644 53225284
Hypotension 296.78 23.62 43 92095 254033 53002895
Joint swelling 292.76 23.62 32 92106 234606 53022322
Implant site discharge 288.17 23.62 63 92075 76 53256852
Drug intolerance 269.57 23.62 23 92115 205470 53051458
Maternal exposure before pregnancy 268.86 23.62 150 91988 5536 53251392
Mood altered 265.29 23.62 208 91930 13693 53243235
Implant site discolouration 262.80 23.62 49 92089 0 53256928
Implant site inflammation 260.00 23.62 59 92079 95 53256833
Breast tenderness 253.96 23.62 109 92029 2237 53254691
Rash 253.35 23.62 239 91899 445952 52810976
Confusional state 251.33 23.62 23 92115 194198 53062730
Haemorrhage 249.03 23.62 396 91742 57591 53199337
Circumstance or information capable of leading to medication error 248.49 23.62 124 92014 3630 53253298
Drug hypersensitivity 246.37 23.62 76 92062 265166 52991762
Vomiting 243.79 23.62 301 91837 496838 52760090
Neutropenia 239.02 23.62 8 92130 159177 53097751
Intentional medical device removal by patient 237.69 23.62 61 92077 205 53256723
Cough 236.09 23.62 75 92063 256818 53000110
Asthenia 226.04 23.62 159 91979 343431 52913497
Pregnancy on contraceptive 222.15 23.62 83 92055 1166 53255762
Ectopic pregnancy 217.39 23.62 103 92035 2684 53254244
Infusion related reaction 214.31 23.62 14 92124 155943 53100985
Implant site vesicles 211.64 23.62 40 92098 3 53256925
Breast pain 208.42 23.62 146 91992 8083 53248845
Implant site warmth 208.09 23.62 40 92098 7 53256921
Malaise 202.29 23.62 192 91946 357425 52899503
Nasopharyngitis 199.62 23.62 44 92094 192251 53064677
Anaemia 198.39 23.62 116 92022 276602 52980326
Implant site abscess 194.65 23.62 37 92101 4 53256924
General physical health deterioration 191.13 23.62 17 92121 146925 53110003
Gait disturbance 189.78 23.62 25 92113 158817 53098111
White blood cell count decreased 187.74 23.62 6 92132 124469 53132459
Implant site urticaria 183.93 23.62 35 92103 4 53256924
Treatment failure 181.02 23.62 10 92128 128393 53128535
Withdrawal bleed 177.32 23.62 42 92096 90 53256838
Implant site induration 176.99 23.62 33 92105 0 53256928
Vulvovaginal discomfort 176.02 23.62 84 92054 2225 53254703
Contraindicated product administered 175.56 23.62 16 92122 135613 53121315
Product storage error 175.39 23.62 160 91978 12970 53243958
Abdominal discomfort 174.15 23.62 82 92056 220980 53035948
Haemoglobin decreased 167.94 23.62 20 92118 137287 53119641
Thrombocytopenia 167.73 23.62 21 92117 138706 53118222
Renal failure 167.67 23.62 9 92129 118443 53138485
Sepsis 165.77 23.62 27 92111 146402 53110526
Somnolence 163.10 23.62 44 92094 167690 53089238
Incorrect route of product administration 162.53 23.62 183 91955 19061 53237867
Constipation 157.19 23.62 73 92065 198339 53058589
Dehydration 156.70 23.62 48 92090 168362 53088566
Application site discomfort 154.66 23.62 47 92091 331 53256597
Musculoskeletal stiffness 153.29 23.62 17 92121 123351 53133577
Therapeutic product effect decreased 151.95 23.62 19 92119 125636 53131292
Arthropathy 151.63 23.62 30 92108 141423 53115505
Hepatic enzyme increased 148.03 23.62 21 92117 126174 53130754
Chlamydial infection 144.17 23.62 44 92094 315 53256613
Stomatitis 143.62 23.62 6 92132 98152 53158776
Decreased appetite 143.15 23.62 98 92040 214876 53042052
Lower respiratory tract infection 142.39 23.62 3 92135 90978 53165950
Atrial fibrillation 142.29 23.62 14 92124 111638 53145290
Migraine 140.67 23.62 379 91759 80038 53176890
Cardiac failure congestive 138.00 23.62 5 92133 92752 53164176
Hormone level abnormal 137.35 23.62 72 92066 2341 53254587
Hyponatraemia 134.84 23.62 15 92123 108592 53148336
Systemic lupus erythematosus 133.58 23.62 27 92111 125387 53131541
Therapeutic product effect incomplete 133 23.62 6 92132 91778 53165150
Respiratory failure 132.39 23.62 11 92127 100501 53156427
Pruritus 130.38 23.62 191 91947 293641 52963287
Renal impairment 129.39 23.62 3 92135 83315 53173613
Product shape issue 129.08 23.62 34 92104 130 53256798
Sinusitis 127.45 23.62 66 92072 168498 53088430
Wrong technique in device usage process 127.10 23.62 70 92068 2517 53254411
Vena cava filter insertion 125.14 23.62 35 92103 176 53256752
Pain in extremity 124.84 23.62 881 91257 284169 52972759
Oedema peripheral 123.12 23.62 71 92067 170716 53086212
Hypercoagulation 120.80 23.62 64 92074 2127 53254801
Cardiac failure 120.00 23.62 7 92131 85837 53171091
Abortion 118.95 23.62 65 92073 2301 53254627
Oxygen saturation decreased 114.60 23.62 4 92134 76721 53180207
Abnormal uterine bleeding 114.01 23.62 53 92085 1321 53255607
Implant site haematoma 113.63 23.62 27 92111 59 53256869
Nausea 111.81 23.62 807 91331 755284 52501644
Pelvic pain 111.03 23.62 121 92017 12152 53244776
Neuropathy peripheral 110.32 23.62 22 92116 103165 53153763
Pain 109.74 23.62 584 91554 587814 52669114
Implant site oedema 108.97 23.62 21 92117 4 53256924
Infertility female 108.27 23.62 41 92097 599 53256329
Hypertension 107.51 23.62 139 91999 225292 53031636
Product prescribing issue 106.65 23.62 49 92089 1188 53255740
Alanine aminotransferase increased 106.56 23.62 18 92120 95077 53161851
Urinary tract infection 105.34 23.62 157 91981 239746 53017182
Hypoaesthesia 105.30 23.62 482 91656 132513 53124415
Breast feeding 104.95 23.62 44 92094 850 53256078
Leukopenia 102.65 23.62 6 92132 73457 53183471
Dysphagia 101.44 23.62 13 92125 84384 53172544
Injection site pain 100.71 23.62 35 92103 113356 53143572
Ovarian cyst 99.06 23.62 127 92011 15142 53241786
Bradycardia 98.68 23.62 6 92132 71050 53185878
Myocardial infarction 98.55 23.62 25 92113 99329 53157599
Aspartate aminotransferase increased 98.48 23.62 14 92124 84015 53172913
Herpes zoster 95.03 23.62 9 92129 74010 53182918
Limb discomfort 93.02 23.62 162 91976 25360 53231568
Hospitalisation 92.88 23.62 8 92130 71004 53185924
Libido decreased 92.71 23.62 58 92080 2651 53254277
Arthritis 92.51 23.62 19 92119 87279 53169649
Blood pressure increased 92.18 23.62 65 92073 140414 53116514
Uterine haemorrhage 91.58 23.62 66 92072 3821 53253107
Implant site pustules 91.17 23.62 17 92121 0 53256928
C-reactive protein increased 90.58 23.62 7 92131 67879 53189049
Osteoarthritis 89.36 23.62 9 92129 70477 53186451
Dry mouth 89.30 23.62 3 92135 59547 53197381
Influenza 89.00 23.62 27 92111 95352 53161576
Pulmonary infarction 87.79 23.62 57 92081 2780 53254148
Wound 87.11 23.62 25 92113 91532 53165396
Tremor 86.77 23.62 55 92083 125681 53131247
Hypersensitivity 86.63 23.62 144 91994 210521 53046407
Implant site hypersensitivity 85.69 23.62 20 92118 39 53256889
Chills 85.44 23.62 37 92101 104811 53152117
Interstitial lung disease 84.37 23.62 4 92134 58618 53198310
Septic shock 84.22 23.62 6 92132 62223 53194705
Wheezing 83.63 23.62 8 92130 65267 53191661
Loss of personal independence in daily activities 83.30 23.62 11 92127 69804 53187124
Poor quality device used 81.92 23.62 53 92085 2569 53254359
Cervical dysplasia 81.14 23.62 56 92082 3025 53253903
Depressed level of consciousness 80.71 23.62 3 92135 54425 53202503
Ulnar nerve injury 79.70 23.62 18 92120 28 53256900
Hypoxia 79.49 23.62 4 92134 55676 53201252
Intentional overdose 79.21 23.62 11 92127 67194 53189734
Infection 79.19 23.62 109 92029 172096 53084832
Hypoglycaemia 78.98 23.62 6 92132 59007 53197921
Drug abuse 78.96 23.62 10 92128 65516 53191412
Intentional product use issue 78.44 23.62 15 92123 72479 53184449
Product colour issue 78.27 23.62 34 92104 719 53256209
Coma 78.03 23.62 8 92130 61775 53195153
Insomnia 77.71 23.62 127 92011 186945 53069983
Cerebral venous sinus thrombosis 77.60 23.62 46 92092 1906 53255022
Needle issue 77.56 23.62 77 92061 6935 53249993
Balance disorder 77.43 23.62 16 92122 73191 53183737
Coital bleeding 77.13 23.62 30 92108 473 53256455
Product administration error 76.30 23.62 135 92003 21396 53235532
Cardio-respiratory arrest 75.81 23.62 7 92131 58751 53198177
Bronchitis 75.77 23.62 50 92088 111849 53145079
Memory impairment 75.53 23.62 26 92112 84731 53172197
Scar 75.25 23.62 101 92037 12592 53244336
Implant site necrosis 75.08 23.62 14 92124 0 53256928
Cardiac arrest 74.83 23.62 34 92104 93633 53163295
Swelling 74.57 23.62 135 92003 190970 53065958
Gastrointestinal disorder 72.95 23.62 32 92106 89972 53166956
Hypokalaemia 72.60 23.62 38 92100 96479 53160449
Tachycardia 72.40 23.62 49 92089 108163 53148765
Neutrophil count decreased 71.81 23.62 3 92135 49095 53207833
Oedema 71.28 23.62 20 92118 74326 53182602
Vaginal infection 70.83 23.62 71 92067 6470 53250458
Pulmonary oedema 70.39 23.62 6 92132 53717 53203211
Blood glucose increased 70.21 23.62 23 92115 77338 53179590
Cataract 69.48 23.62 4 92134 49616 53207312
Female sterilisation 68.02 23.62 29 92109 585 53256343
Alopecia 67.79 23.62 195 91943 234388 53022540
Flushing 67.67 23.62 19 92119 70581 53186347
Erythema 67.61 23.62 104 92034 156865 53100063
Myalgia 67.06 23.62 79 92059 133412 53123516
Vulvovaginal pain 66.49 23.62 45 92093 2354 53254574
Agitation 65.88 23.62 11 92127 58615 53198313
Unwanted pregnancy 65.84 23.62 16 92122 40 53256888
Therapy non-responder 65.71 23.62 5 92133 49115 53207813
Bone pain 65.55 23.62 6 92132 50716 53206212
Blister 65.42 23.62 27 92111 78726 53178202
Peripheral swelling 64.30 23.62 165 91973 205943 53050985
Keloid scar 63.73 23.62 21 92117 198 53256730
Psoriasis 63.01 23.62 36 92102 87053 53169875
Hallucination 63.00 23.62 9 92129 53829 53203099
Emotional disorder 62.92 23.62 94 92044 12936 53243992
Blood pressure decreased 62.45 23.62 15 92123 61854 53195074
Chronic kidney disease 62.28 23.62 3 92135 43367 53213561
Adnexa uteri pain 61.21 23.62 24 92114 387 53256541
Productive cough 60.82 23.62 12 92126 56717 53200211
Thrombectomy 60.10 23.62 20 92118 195 53256733
Vulvovaginal mycotic infection 59.06 23.62 56 92082 4766 53252162
Implant site nerve injury 58.99 23.62 11 92127 0 53256928
Encapsulation reaction 58.99 23.62 11 92127 0 53256928
Osteoporosis 58.71 23.62 6 92132 46454 53210474
Premenstrual syndrome 58.37 23.62 27 92111 665 53256263
Dysphonia 56.87 23.62 4 92134 41934 53214994
Psoriatic arthropathy 56.52 23.62 8 92130 48182 53208746
Device failure 56.39 23.62 61 92077 6074 53250854
Dyspepsia 56.25 23.62 32 92106 77568 53179360
Smear cervix abnormal 56.00 23.62 43 92095 2743 53254185
Chest discomfort 55.64 23.62 54 92084 99641 53157287
Blood cholesterol increased 55.17 23.62 12 92126 52977 53203951
Helicobacter infection 55.16 23.62 3 92135 39066 53217862
Depression 54.64 23.62 519 91619 182533 53074395
Metabolic acidosis 54.58 23.62 5 92133 42237 53214691
Administration site discomfort 54.42 23.62 16 92122 99 53256829
Injection site erythema 54.37 23.62 33 92105 77216 53179712
Lung disorder 53.76 23.62 9 92129 47870 53209058
Hyperhidrosis 53.36 23.62 53 92085 96740 53160188
Fluid retention 53.34 23.62 14 92124 54387 53202541
Device physical property issue 53.30 23.62 35 92103 1740 53255188
Device use issue 52.90 23.62 36 92102 1900 53255028
Haematocrit decreased 52.29 23.62 3 92135 37328 53219600
Infertility 52.25 23.62 25 92113 666 53256262
Rhinorrhoea 52.13 23.62 14 92124 53564 53203364
Anaphylactic reaction 51.77 23.62 18 92120 58308 53198620
Poor quality product administered 50.74 23.62 43 92095 3158 53253770
Blood alkaline phosphatase increased 50.60 23.62 6 92132 41356 53215572
Pleural effusion 50.58 23.62 47 92091 88532 53168396
Bacterial vaginosis 50.28 23.62 28 92110 1029 53255899
Ill-defined disorder 49.88 23.62 12 92126 49432 53207496
Loss of consciousness 49.81 23.62 75 92063 114137 53142791
Accidental underdose 49.53 23.62 24 92114 658 53256270
Mobility decreased 49.08 23.62 36 92102 76235 53180693
Heart rate increased 49.01 23.62 42 92096 82273 53174655
Ruptured ectopic pregnancy 48.74 23.62 21 92117 435 53256493
Suppressed lactation 48.48 23.62 21 92117 441 53256487
Implant site nodule 48.27 23.62 9 92129 0 53256928
Nasal congestion 48.07 23.62 16 92122 53271 53203657
Mental status changes 47.77 23.62 6 92132 39565 53217363
Pneumonia aspiration 47.31 23.62 3 92135 34298 53222630
Pain in jaw 47.12 23.62 7 92131 40662 53216266
White blood cell count increased 47.09 23.62 11 92127 46234 53210694
Diverticulitis 46.90 23.62 4 92134 35797 53221131
Circumstance or information capable of leading to device use error 46.64 23.62 15 92123 130 53256798
Dysgeusia 46.19 23.62 9 92129 42922 53214006
Asthma 46.14 23.62 73 92065 108899 53148029
Blood pressure systolic increased 45.89 23.62 4 92134 35173 53221755
Ascites 45.67 23.62 7 92131 39728 53217200
International normalised ratio increased 45.49 23.62 13 92125 47748 53209180
Upper respiratory tract infection 45.26 23.62 32 92106 69065 53187863
Inflammation 45.22 23.62 21 92117 57115 53199813
Breast discharge 45.18 23.62 25 92113 907 53256021
Ectopic pregnancy with contraceptive device 44.81 23.62 27 92111 1153 53255775
Epistaxis 44.77 23.62 32 92106 68678 53188250
Cerebral venous thrombosis 44.55 23.62 35 92103 2309 53254619
Papilloma viral infection 43.71 23.62 28 92110 1334 53255594
Loss of libido 43.69 23.62 28 92110 1335 53255593
Incorrect dose administered 43.21 23.62 17 92121 51028 53205900
Folliculitis 43.07 23.62 3 92135 31706 53225222
Cognitive disorder 43.00 23.62 12 92126 44766 53212162
Dyspareunia 42.92 23.62 35 92103 2436 53254492
Muscular weakness 42.43 23.62 68 92070 100924 53156004
Dyspnoea exertional 42.33 23.62 21 92117 54979 53201949
Rectal haemorrhage 41.97 23.62 10 92128 41471 53215457
Hepatic failure 41.86 23.62 6 92132 35800 53221128
Persistent genital arousal disorder 41.85 23.62 17 92121 302 53256626
Sleep disorder 41.63 23.62 25 92113 58845 53198083
Vulvovaginal swelling 41.34 23.62 19 92119 461 53256467
Blood pressure fluctuation 41.34 23.62 6 92132 35464 53221464
Diabetes mellitus 40.85 23.62 21 92117 53878 53203050
Disorientation 40.80 23.62 9 92129 39350 53217578
Suicide attempt 40.72 23.62 25 92113 58143 53198785
Liver function test abnormal 40.70 23.62 16 92122 48055 53208873
Venous stent insertion 40.66 23.62 9 92129 12 53256916
Coronary artery disease 40.53 23.62 5 92133 33432 53223496
Blood potassium decreased 40.46 23.62 10 92128 40450 53216478
Therapeutic response decreased 40.00 23.62 16 92122 47553 53209375
Vulvovaginal burning sensation 39.62 23.62 29 92109 1720 53255208
Muscle spasms 39.61 23.62 381 91757 134414 53122514
Magnetic resonance imaging 39.31 23.62 12 92126 86 53256842
Gait inability 39.23 23.62 9 92129 38302 53218626
Lethargy 39.20 23.62 22 92116 53738 53203190
Cardiac disorder 39.17 23.62 16 92122 46950 53209978
Drug-induced liver injury 39.03 23.62 3 92135 29230 53227698
Encephalopathy 39.01 23.62 8 92130 36800 53220128
Melaena 38.86 23.62 3 92135 29126 53227802
Respiratory distress 38.78 23.62 6 92132 33821 53223107
Injection site reaction 38.68 23.62 20 92118 51146 53205782
Drug interaction 38.31 23.62 222 91916 219107 53037821
Vertigo 38.03 23.62 25 92113 56056 53200872
Hyperglycaemia 38.01 23.62 11 92127 40073 53216855
Multiple sclerosis relapse 37.86 23.62 15 92123 44838 53212090
Visual impairment 37.85 23.62 42 92096 72870 53184058
Product quality control issue 37.77 23.62 9 92129 20 53256908
Oropharyngeal pain 37.77 23.62 51 92087 81217 53175711
Endometriosis 37.65 23.62 42 92096 4327 53252601
Blood bilirubin increased 37.38 23.62 8 92130 35722 53221206
Hepatic function abnormal 37.13 23.62 9 92129 36890 53220038
COVID-19 37.11 23.62 9 92129 36879 53220049
Uterine dilation and curettage 37.03 23.62 22 92116 915 53256013
Polycystic ovaries 36.95 23.62 31 92107 2245 53254683
Hypophagia 36.79 23.62 5 92133 31057 53225871
Fibromyalgia 36.78 23.62 15 92123 44060 53212868
Fluid overload 36.76 23.62 3 92135 27828 53229100
Colitis 36.57 23.62 13 92125 41539 53215389
Liposuction 36.35 23.62 9 92129 25 53256903
Liver disorder 36.32 23.62 12 92126 40143 53216785
Gamma-glutamyltransferase increased 36.17 23.62 7 92131 33548 53223380
Unresponsive to stimuli 35.97 23.62 7 92131 33419 53223509
Tonsillectomy 35.93 23.62 21 92117 847 53256081
Discomfort 35.38 23.62 284 91854 95188 53161740
May-Thurner syndrome 35.36 23.62 9 92129 29 53256899
Anticoagulation drug level below therapeutic 35.28 23.62 20 92118 761 53256167
Oral pain 35.15 23.62 3 92135 26834 53230094
Colposcopy 35.12 23.62 9 92129 30 53256898
Abortion spontaneous complete 35.05 23.62 7 92131 3 53256925
Intentional product misuse 34.89 23.62 21 92117 49371 53207557
Liver function test increased 34.81 23.62 3 92135 26625 53230303
Product use in unapproved indication 34.78 23.62 321 91817 111968 53144960
Injection site swelling 34.78 23.62 15 92123 42613 53214315
Osteonecrosis 34.72 23.62 3 92135 26572 53230356
Lymphocyte count decreased 34.48 23.62 4 92134 28048 53228880
Skin exfoliation 34.04 23.62 10 92128 36073 53220855
Dizziness 33.66 23.62 447 91691 371812 52885116
Dysarthria 33.54 23.62 14 92124 40554 53216374
Heart rate decreased 33.49 23.62 11 92127 36936 53219992
Nipple pain 33.41 23.62 14 92124 270 53256658
Pericardial effusion 33.26 23.62 4 92134 27274 53229654
Speech disorder 33.24 23.62 13 92125 39168 53217760
Intestinal obstruction 33.17 23.62 5 92133 28736 53228192
Hepatocellular injury 32.87 23.62 6 92132 29980 53226948
Breast enlargement 32.77 23.62 25 92113 1579 53255349
Implantation complication 32.70 23.62 7 92131 7 53256921
Hepatitis 32.70 23.62 9 92129 33885 53223043
Orthostatic hypotension 32.51 23.62 6 92132 29747 53227181
Unevaluable event 32.31 23.62 23 92115 49475 53207453
Vaginal odour 32.26 23.62 16 92122 462 53256466
Implant site papules 32.18 23.62 6 92132 0 53256928
Implant site cyst 32.18 23.62 6 92132 0 53256928
Implant site injury 32.18 23.62 6 92132 0 53256928
Red blood cell sedimentation rate increased 32.11 23.62 5 92133 28052 53228876
Hypomagnesaemia 31.88 23.62 3 92135 24808 53232120
Serotonin syndrome 31.88 23.62 4 92134 26402 53230526
Stevens-Johnson syndrome 31.51 23.62 3 92135 24579 53232349
Haematochezia 31.36 23.62 17 92121 42341 53214587
Pregnancy test negative 31.35 23.62 7 92131 10 53256918
Joint stiffness 31.23 23.62 7 92131 30276 53226652
Respiratory disorder 31.17 23.62 10 92128 34087 53222841
Hypercalcaemia 31.14 23.62 3 92135 24345 53232583
Pancreatitis 30.70 23.62 21 92117 46121 53210807
Abdominal pain lower 30.55 23.62 100 92038 23493 53233435
Device extrusion 30.09 23.62 8 92130 32 53256896
Urinary incontinence 30.08 23.62 8 92130 30813 53226115
Therapy cessation 29.89 23.62 6 92132 28019 53228909
Drug withdrawal syndrome 29.88 23.62 6 92132 28016 53228912
Clostridium difficile infection 29.69 23.62 6 92132 27887 53229041
Swelling face 29.59 23.62 33 92105 57135 53199793
Injection site bruising 29.53 23.62 14 92124 37632 53219296
Throat irritation 29.48 23.62 9 92129 31672 53225256
Bacterial vulvovaginitis 29.31 23.62 17 92121 676 53256252
Foreign body reaction 29.30 23.62 9 92129 66 53256862
Cystitis 29.17 23.62 23 92115 46965 53209963
Thrombosis 28.93 23.62 192 91946 60601 53196327
Seizure 28.39 23.62 121 92017 129388 53127540
Respiratory tract infection 28.22 23.62 11 92127 33213 53223715
Superior sagittal sinus thrombosis 27.75 23.62 18 92120 876 53256052
Medical device site scab 27.63 23.62 7 92131 22 53256906
Renal disorder 27.62 23.62 8 92130 29131 53227797
Protein S deficiency 27.56 23.62 8 92130 47 53256881
Gastric bypass 27.40 23.62 22 92116 1498 53255430
Amnesia 27.08 23.62 23 92115 45265 53211663
Pancreatitis acute 27.00 23.62 6 92132 26103 53230825
Cholestasis 26.98 23.62 8 92130 28687 53228241
Medical device site movement impairment 26.82 23.62 5 92133 0 53256928
Product sterility lacking 26.82 23.62 5 92133 0 53256928
Affective disorder 26.80 23.62 40 92098 5499 53251429
Palpitations 26.74 23.62 89 92049 102259 53154669
Acute myocardial infarction 26.63 23.62 12 92126 33223 53223705
Dry skin 26.45 23.62 24 92114 45736 53211192
Post thrombotic syndrome 26.34 23.62 15 92123 576 53256352
Thrombolysis 26.32 23.62 9 92129 96 53256832
Injection site pruritus 26.27 23.62 20 92118 41569 53215359
Circulatory collapse 26.10 23.62 4 92134 22710 53234218
Restlessness 26.10 23.62 8 92130 28079 53228849
Pulmonary fibrosis 26.09 23.62 5 92133 24130 53232798
Type 2 diabetes mellitus 26.06 23.62 11 92127 31659 53225269
Paraesthesia 25.82 23.62 335 91803 127180 53129748
Vulvovaginal dryness 25.60 23.62 26 92112 2406 53254522
Agranulocytosis 25.50 23.62 5 92133 23744 53233184
Acute respiratory failure 25.50 23.62 11 92127 31247 53225681
Medical device site pain 25.22 23.62 11 92127 235 53256693
Implant site extravasation 25.08 23.62 14 92124 517 53256411
Rash maculo-papular 25.02 23.62 10 92128 29739 53227189
Urinary retention 24.89 23.62 9 92129 28457 53228471
Aphasia 24.84 23.62 11 92127 30767 53226161
Product expiration date issue 24.69 23.62 6 92132 15 53256913
Chlamydia test positive 24.58 23.62 7 92131 38 53256890
Tinnitus 24.48 23.62 11 92127 30508 53226420
Exploratory operation 24.47 23.62 5 92133 3 53256925
Laboratory test abnormal 24.47 23.62 6 92132 24403 53232525
Neoplasm malignant 24.32 23.62 7 92131 25594 53231334
Arrhythmia 24.12 23.62 17 92121 36762 53220166
Ejection fraction decreased 23.98 23.62 3 92135 19845 53237083
Pregnancy test false positive 23.81 23.62 10 92128 194 53256734
Gastrooesophageal reflux disease 23.63 23.62 69 92069 82594 53174334

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

Pharmacologic Action:

SourceCodeDescription
ATC G03AC08 GENITO URINARY SYSTEM AND SEX HORMONES
SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM
HORMONAL CONTRACEPTIVES FOR SYSTEMIC USE
Progestogens
FDA CS M0447349 Progesterone Congeners
FDA EPC N0000175602 Progestin
MeSH PA D003270 Contraceptive Agents
MeSH PA D003271 Contraceptive Agents, Female
MeSH PA D000080066 Contraceptive Agents, Hormonal
MeSH PA D012102 Reproductive Control Agents
CHEBI has role CHEBI:49323 contraceptive agent
CHEBI has role CHEBI:49324 female contraceptive agent
CHEBI has role CHEBI:59826 progestins

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Contraception indication 13197004
Heart valve disorder contraindication 368009 DOID:4079
Hypercholesterolemia contraindication 13644009
Toxic shock syndrome contraindication 18504008 DOID:14115
Myocardial infarction contraindication 22298006 DOID:5844
Diplopia contraindication 24982008
Retinal hemorrhage contraindication 28998008
Depressive disorder contraindication 35489007
Migraine contraindication 37796009 DOID:6364
Hypertensive disorder contraindication 38341003 DOID:10763
Disorder of gallbladder contraindication 39621005 DOID:0060262
Body fluid retention contraindication 43498006
Thrombosis of retinal vein contraindication 46085004
Chronic heart failure contraindication 48447003
Dementia contraindication 52448006
Systemic lupus erythematosus contraindication 55464009 DOID:9074
Hyperlipidemia contraindication 55822004 DOID:1168
Cerebrovascular disease contraindication 62914000 DOID:6713
Thrombophlebitis contraindication 64156001 DOID:3875
Intermenstrual bleeding - irregular contraindication 64996003
Diabetes mellitus contraindication 73211009 DOID:9351
Kidney disease contraindication 90708001 DOID:557
Malignant neoplasm of liver contraindication 93870000 DOID:3571
Deep venous thrombosis contraindication 128053003
Seizure disorder contraindication 128613002
Bed-ridden contraindication 160685001
Asthma contraindication 195967001 DOID:2841
Cerebrovascular accident contraindication 230690007
Pulmonary thromboembolism contraindication 233935004
Disease of liver contraindication 235856003 DOID:409
Cholestasis of pregnancy contraindication 235888006
Metabolic syndrome X contraindication 237602007 DOID:14221
Endometrial carcinoma contraindication 254878006 DOID:2871
Pregnancy, function contraindication 289908002
Hypertriglyceridemia contraindication 302870006
Functional visual loss contraindication 313165001
Non-Q wave myocardial infarction contraindication 314207007
Malignant tumor of ovary contraindication 363443007 DOID:2394
Thromboembolic disorder contraindication 371039008
Disorder of coronary artery contraindication 414024009
Obesity contraindication 414916001 DOID:9970
Estrogen receptor positive tumor contraindication 416053008
Porphyria contraindication 418470004
Optic disc edema contraindication 423341008 DOID:146
Hypertensive urgency contraindication 443482000
Carcinoma of female breast contraindication 447782002
Smokes tobacco daily contraindication 449868002
Worsening Headache Disorder contraindication
Major Surgery with Prolonged Post-Operative Immobilization contraindication
Diabetes with Vascular Disease Complication contraindication
Benign Hepatic Cell Adenoma contraindication

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 13.93 acidic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
68MG/IMPLANT IMPLANON ORGANON N021529 July 17, 2006 DISCN IMPLANT IMPLANTATION 9757552 July 28, 2030 PREVENTION OF PREGNANCY
68MG/IMPLANT NEXPLANON ORGANON N021529 May 31, 2011 RX IMPLANT IMPLANTATION 9757552 July 28, 2030 PREVENTION OF PREGNANCY

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Progesterone receptor Nuclear hormone receptor AGONIST WOMBAT-PK CHEMBL
Estrogen receptor Nuclear hormone receptor WOMBAT-PK
Sex hormone-binding globulin Secreted Kd 8.23 CHEMBL

External reference:

IDSource
4021294 VUID
N0000179018 NUI
D04104 KEGG_DRUG
4021294 VANDF
C0047683 UMLSCUI
CHEBI:50777 CHEBI
CHEMBL1531 ChEMBL_ID
CHEMBL1697750 ChEMBL_ID
DB00294 DRUGBANK_ID
C044815 MESH_SUPPLEMENTAL_RECORD_UI
6917715 PUBCHEM_CID
7590 IUPHAR_LIGAND_ID
6832 INN_ID
304GTH6RNH UNII
14584 RXNORM
16189 MMSL
51895 MMSL
d04772 MMSL
007906 NDDF
326451000 SNOMEDCT_US
396050000 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
NuvaRing HUMAN PRESCRIPTION DRUG LABEL 2 0052-0273 INSERT, EXTENDED RELEASE 0.12 mg VAGINAL NDA 28 sections
Nexplanon HUMAN PRESCRIPTION DRUG LABEL 1 0052-4330 IMPLANT 68 mg SUBCUTANEOUS NDA 29 sections
Etonogestrel and Ethinyl Estradiol HUMAN PRESCRIPTION DRUG LABEL 2 0093-7679 INSERT, EXTENDED RELEASE 0.12 mg VAGINAL ANDA 29 sections
NUVARING HUMAN PRESCRIPTION DRUG LABEL 2 50090-1008 INSERT, EXTENDED RELEASE 0.12 mg VAGINAL NDA 27 sections
NUVARING HUMAN PRESCRIPTION DRUG LABEL 2 50090-5611 INSERT, EXTENDED RELEASE 0.12 mg VAGINAL NDA 27 sections
NuvaRing HUMAN PRESCRIPTION DRUG LABEL 2 54868-4832 INSERT, EXTENDED RELEASE 11.70 mg VAGINAL NDA 25 sections
EluRyng HUMAN PRESCRIPTION DRUG LABEL 2 65162-469 RING 0.12 mg VAGINAL ANDA 29 sections
Etonogestrel/Ethinyl Estradiol HUMAN PRESCRIPTION DRUG LABEL 2 66993-605 INSERT, EXTENDED RELEASE 0.12 mg VAGINAL NDA AUTHORIZED GENERIC 30 sections
NuvaRing HUMAN PRESCRIPTION DRUG LABEL 2 76413-131 INSERT, EXTENDED RELEASE 0.12 mg VAGINAL NDA 28 sections
Nexplanon HUMAN PRESCRIPTION DRUG LABEL 1 78206-145 IMPLANT 68 mg SUBCUTANEOUS NDA 29 sections
NuvaRing HUMAN PRESCRIPTION DRUG LABEL 2 78206-146 INSERT, EXTENDED RELEASE 0.12 mg VAGINAL NDA 29 sections