etonogestrel ๐Ÿถ Veterinary Use | 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 ยตM/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 18400.29 52.96 4852 58723 28726 50512823
Complication associated with device 14389.93 52.96 3388 60187 11267 50530282
Device difficult to use 11365.55 52.96 2601 60974 7285 50534264
Device breakage 10845.94 52.96 2488 61087 7059 50534490
Incorrect product administration duration 10272.17 52.96 2368 61207 6907 50534642
Device deployment issue 10259.82 52.96 1997 61578 1499 50540050
Product quality issue 10146.49 52.96 2998 60577 27860 50513689
Complication of device removal 8410.80 52.96 1743 61832 2421 50539128
Complication of device insertion 8396.75 52.96 1858 61717 4183 50537366
Implant site pain 6789.77 52.96 1309 62266 860 50540689
Pregnancy with implant contraceptive 6419.37 52.96 1235 62340 788 50540761
Device kink 5738.17 52.96 1104 62471 703 50540846
Unintended pregnancy 5676.58 52.96 1302 62273 3644 50537905
Device dislocation 4846.81 52.96 1569 62006 19977 50521572
Heavy menstrual bleeding 4394.26 52.96 1348 62227 14189 50527360
Menstruation irregular 4374.30 52.96 1101 62474 5061 50536488
Intermenstrual bleeding 2707.56 52.96 770 62805 6044 50535505
Amenorrhoea 2575.22 52.96 778 62797 7706 50533843
Device expulsion 2557.04 52.96 1058 62517 27764 50513785
Vaginal haemorrhage 2135.75 52.96 889 62686 23662 50517887
Implant site erythema 1834.73 52.96 347 63228 169 50541380
Implant site pruritus 1659.83 52.96 318 63257 188 50541361
Device placement issue 1565.83 52.96 328 63247 488 50541061
Implant site bruising 1336.29 52.96 245 63330 63 50541486
Implant site swelling 1211.94 52.96 241 63334 223 50541326
Implant site infection 1185.88 52.96 266 63309 642 50540907
Implant site scar 1062.24 52.96 196 63379 59 50541490
Implant site fibrosis 979.94 52.96 174 63401 9 50541540
General anaesthesia 977.13 52.96 173 63402 6 50541543
Device issue 930.93 52.96 469 63106 19503 50522046
Menstrual disorder 741.30 52.96 258 63317 4112 50537437
Implant site irritation 730.32 52.96 133 63442 28 50541521
Menometrorrhagia 668.12 52.96 165 63410 684 50540865
Mood swings 663.34 52.96 347 63228 15607 50525942
Menstruation delayed 651.20 52.96 180 63395 1251 50540298
Drug ineffective 610.32 52.96 143 63432 819190 49722359
Adverse event 594.85 52.96 470 63105 43293 50498256
Diarrhoea 574.99 52.96 44 63531 588432 49953117
Medical device site discomfort 565.87 52.96 113 63462 109 50541440
Polymenorrhoea 562.52 52.96 152 63423 959 50540590
Device embolisation 539.75 52.96 95 63480 0 50541549
Weight increased 536.91 52.96 931 62644 200960 50340589
Implant site rash 524.08 52.96 99 63476 47 50541502
Dysmenorrhoea 521.54 52.96 185 63390 3125 50538424
Medical device removal 466.45 52.96 132 63443 1010 50540539
Implant site hypoaesthesia 457.26 52.96 81 63494 3 50541546
Menstruation normal 450.07 52.96 90 63485 88 50541461
Hypomenorrhoea 441.31 52.96 104 63471 336 50541213
Pneumonia 432.40 52.96 9 63566 378392 50163157
Abortion spontaneous 431.61 52.96 383 63192 41389 50500160
Off label use 426.96 52.96 49 63526 474377 50067172
Implant site reaction 425.07 52.96 82 63493 53 50541496
Dyspnoea 405.68 52.96 96 63479 547512 49994037
Implant site haemorrhage 398.18 52.96 74 63501 26 50541523
Fatigue 368.12 52.96 218 63357 707383 49834166
Death 366.69 52.96 9 63566 325370 50216179
Abortion induced 334.35 52.96 184 63391 9160 50532389
Implant site paraesthesia 329.52 52.96 58 63517 0 50541549
Implant site cellulitis 326.59 52.96 58 63517 3 50541546
Implant site discharge 323.82 52.96 65 63510 66 50541483
Oligomenorrhoea 315.90 52.96 87 63488 595 50540954
Surgery 310.04 52.96 276 63299 29929 50511620
Condition aggravated 307.81 52.96 16 63559 297042 50244507
Arthralgia 303.39 52.96 88 63487 438614 50102935
Pyrexia 303.02 52.96 56 63519 380147 50161402
Implant site mass 295.16 52.96 54 63521 13 50541536
Expired product administered 288.13 52.96 139 63436 5243 50536306
Fall 285.44 52.96 41 63534 334891 50206658
Implant site discolouration 267.02 52.96 47 63528 0 50541549
Implant site inflammation 259.27 52.96 55 63520 90 50541459
Acne 256.51 52.96 206 63369 19389 50522160
Hypotension 256.04 52.96 9 63566 235460 50306089
Toxicity to various agents 246.70 52.96 4 63571 212495 50329054
Joint swelling 245.50 52.96 16 63559 245270 50296279
Acute kidney injury 240.25 52.96 11 63564 228047 50313502
Circumstance or information capable of leading to medication error 238.79 52.96 104 63471 3084 50538465
Mood altered 238.08 52.96 166 63409 12607 50528942
Drug hypersensitivity 227.64 52.96 25 63550 250985 50290564
Drug intolerance 223.12 52.96 13 63562 219091 50322458
Rheumatoid arthritis 222.79 52.96 7 63568 202543 50339006
Implant site vesicles 221.57 52.96 39 63536 0 50541549
Cough 221.41 52.96 23 63552 241241 50300308
Wrong technique in device usage process 219.04 52.96 91 63484 2395 50539154
Breast tenderness 213.33 52.96 85 63490 2003 50539546
Vomiting 211.93 52.96 162 63413 460596 50080953
Implant site abscess 204.52 52.96 36 63539 0 50541549
Rash 202.19 52.96 153 63422 437318 50104231
Implant site warmth 198.98 52.96 36 63539 6 50541543
Confusional state 192.47 52.96 10 63565 185918 50355631
Implant site urticaria 189.38 52.96 34 63541 4 50541545
Haemorrhage 187.35 52.96 280 63295 53161 50488388
Nasopharyngitis 186.05 52.96 15 63560 192912 50348637
Anaemia 182.93 52.96 46 63529 252410 50289139
Implant site induration 176.11 52.96 31 63544 0 50541549
Sinusitis 173.95 52.96 10 63565 170548 50371001
Constipation 172.15 52.96 17 63558 185691 50355858
Incorrect route of product administration 167.01 52.96 158 63417 18508 50523041
Neutropenia 166.79 52.96 4 63571 147961 50393588
Asthenia 164.09 52.96 99 63476 318943 50222606
General physical health deterioration 163.92 52.96 3 63572 142431 50399118
Arthropathy 161.82 52.96 9 63566 157897 50383652
Abdominal discomfort 160.63 52.96 46 63529 231595 50309954
Treatment failure 157.98 52.96 3 63572 137634 50403915
Gait disturbance 155.43 52.96 8 63567 149997 50391552
Breast pain 154.68 52.96 104 63471 7440 50534109
Malaise 152.74 52.96 119 63456 335413 50206136
Application site discomfort 151.81 52.96 43 63532 330 50541219
Urinary tract infection 147.21 52.96 49 63526 223971 50317578
Oedema peripheral 144.97 52.96 15 63560 157946 50383603
Systemic lupus erythematosus 144.13 52.96 8 63567 140614 50400935
Hypertension 142.66 52.96 44 63531 211159 50330390
Contraindicated product administered 142.41 52.96 12 63563 148946 50392603
Hepatic enzyme increased 140.23 52.96 8 63567 137372 50404177
Dehydration 136.05 52.96 16 63559 152433 50389116
Therapeutic product effect decreased 135.63 52.96 9 63566 136041 50405508
Musculoskeletal stiffness 132.63 52.96 7 63568 128474 50413075
Haemoglobin decreased 128.05 52.96 8 63567 127208 50414341
Pain in extremity 127.40 52.96 677 62898 272188 50269361
Pregnancy on contraceptive 125.77 52.96 48 63527 1004 50540545
Nausea 120.78 52.96 468 63107 704930 49836619
Somnolence 120.69 52.96 24 63551 154961 50386588
Hormone level abnormal 119.57 52.96 57 63518 2092 50539457
Sepsis 118.47 52.96 14 63561 132911 50408638
Limb discomfort 115.99 52.96 148 63427 24209 50517340
Atrial fibrillation 110.09 52.96 4 63571 101741 50439808
Pain 106.88 52.96 372 63203 578531 49963018
Product prescribing issue 104.03 52.96 44 63531 1212 50540337
Bronchitis 103.48 52.96 7 63568 104152 50437397
Implant site haematoma 102.35 52.96 23 63552 56 50541493
Therapeutic product effect incomplete 101.13 52.96 3 63572 91512 50450037
Vaginal discharge 99.74 52.96 69 63506 5171 50536378
Implant site oedema 99.49 52.96 18 63557 3 50541546
Decreased appetite 96.82 52.96 67 63508 200856 50340693
Breast feeding 95.34 52.96 37 63538 811 50540738
Arthritis 95.26 52.96 3 63572 86718 50454831
Blood pressure increased 94.90 52.96 25 63550 133107 50408442
Hypokalaemia 93.36 52.96 4 63571 87988 50453561
Swelling 92.85 52.96 70 63505 200802 50340747
Needle issue 92.04 52.96 75 63500 7200 50534349
Implant site pustules 90.90 52.96 16 63559 0 50541549
Hypoaesthesia 89.98 52.96 357 63218 126900 50414649
Pruritus 89.67 52.96 136 63439 283432 50258117
Hypersensitivity 89.58 52.96 83 63492 215078 50326471
Device use issue 88.91 52.96 45 63530 1884 50539665
Tremor 84.94 52.96 20 63555 114883 50426666
Injection site pain 84.74 52.96 18 63557 111006 50430543
Myocardial infarction 82.83 52.96 8 63567 89019 50452530
Medical device discomfort 82.82 52.96 41 63534 1636 50539913
Cardiac failure 82.21 52.96 3 63572 76037 50465512
Implant site hypersensitivity 81.96 52.96 16 63559 12 50541537
Tachycardia 80.74 52.96 14 63561 99749 50441800
Infection 80.27 52.96 60 63515 172894 50368655
Alopecia 79.91 52.96 115 63460 244932 50296617
Neuropathy peripheral 79.59 52.96 13 63562 96744 50444805
Chills 79.51 52.96 13 63562 96674 50444875
Insomnia 79.45 52.96 62 63513 174803 50366746
Pleural effusion 79.39 52.96 6 63569 81448 50460101
Abnormal uterine bleeding 79.01 52.96 36 63539 1190 50540359
Ectopic pregnancy 78.24 52.96 44 63531 2283 50539266
Uterine haemorrhage 77.09 52.96 50 63525 3365 50538184
Alanine aminotransferase increased 77.02 52.96 10 63565 88349 50453200
Gastrointestinal disorder 74.83 52.96 14 63561 94442 50447107
Encapsulation reaction 73.85 52.96 13 63562 0 50541549
Dysphagia 72.02 52.96 7 63568 77511 50464038
Memory impairment 71.58 52.96 8 63567 79352 50462197
Gastrooesophageal reflux disease 70.75 52.96 7 63568 76421 50465128
Keloid scar 70.66 52.96 20 63555 153 50541396
Upper respiratory tract infection 69.88 52.96 3 63572 65895 50475654
Herpes zoster 69.59 52.96 5 63570 70781 50470768
Hospitalisation 69.16 52.96 4 63571 67933 50473616
Cerebrovascular accident 68.96 52.96 17 63558 94663 50446886
Bradycardia 68.10 52.96 3 63572 64423 50477126
Aspartate aminotransferase increased 67.56 52.96 9 63566 77989 50463560
Intentional product use issue 66.33 52.96 9 63566 76909 50464640
Scar 66.27 52.96 78 63497 11740 50529809
Wound 66.23 52.96 25 63550 105769 50435780
Influenza 65.36 52.96 16 63559 89522 50452027
Asthma 65.14 52.96 16 63559 89321 50452228
Balance disorder 63.96 52.96 7 63568 70583 50470966
Administration site discomfort 63.18 52.96 16 63559 75 50541474
Drug abuse 62.56 52.96 3 63572 59843 50481706
Implant site nerve injury 62.49 52.96 11 63564 0 50541549
Maternal exposure before pregnancy 61.10 52.96 53 63522 5544 50536005
Ulnar nerve injury 60.18 52.96 14 63561 42 50541507
Blood glucose increased 59.97 52.96 9 63566 71315 50470234
Blood cholesterol increased 56.98 52.96 3 63572 55212 50486337
Wheezing 56.60 52.96 6 63569 62041 50479508
Chest discomfort 56.24 52.96 23 63552 92699 50448850
Coma 55.96 52.96 4 63571 56875 50484674
Psoriasis 55.13 52.96 10 63565 68990 50472559
Flushing 55.11 52.96 9 63566 67006 50474543
Infertility female 54.95 52.96 22 63553 525 50541024
Dyspepsia 54.55 52.96 13 63562 74084 50467465
Unwanted pregnancy 54.37 52.96 12 63563 26 50541523
Pregnancy with contraceptive device 53.60 52.96 43 63532 4036 50537513

FDA Adverse Event Reporting System (Male)

None

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
No adverse event 11809.32 62.16 2917 41101 25644 64429070
Complication associated with device 9592.68 62.16 2186 41832 12894 64441820
Device difficult to use 8825.11 62.16 1890 42128 7908 64446806
Device deployment issue 8058.95 62.16 1432 42586 1394 64453320
Product quality issue 7610.25 62.16 2079 41939 27720 64426994
Device breakage 6803.41 62.16 1497 42521 7258 64447456
Complication of device insertion 6528.80 62.16 1314 42704 3698 64451016
Complication of device removal 6397.71 62.16 1206 42812 2074 64452640
Incorrect product administration duration 6057.27 62.16 1389 42629 8369 64446345
Implant site pain 5613.99 62.16 993 43025 907 64453807
Pregnancy with implant contraceptive 4556.68 62.16 800 43218 664 64454050
Unintended pregnancy 4151.67 62.16 834 43184 2300 64452414
Device kink 3945.93 62.16 724 43294 969 64453745
Device dislocation 3697.68 62.16 1101 42917 20077 64434637
Heavy menstrual bleeding 3640.32 62.16 963 43055 11114 64443600
Menstruation irregular 3124.55 62.16 701 43317 3734 64450980
Device expulsion 2470.38 62.16 809 43209 20327 64434387
Amenorrhoea 2393.53 62.16 609 43409 5930 64448784
Intermenstrual bleeding 2243.79 62.16 551 43467 4574 64450140
Implant site erythema 1615.87 62.16 281 43737 203 64454511
Implant site pruritus 1546.98 62.16 263 43755 134 64454580
Vaginal haemorrhage 1528.99 62.16 553 43465 18791 64435923
Device placement issue 1362.57 62.16 260 43758 486 64454228
Implant site bruising 1124.72 62.16 187 43831 60 64454654
Implant site swelling 1037.20 62.16 189 43829 234 64454480
Implant site fibrosis 867.77 62.16 139 43879 7 64454707
Implant site scar 863.61 62.16 145 43873 58 64454656
General anaesthesia 836.31 62.16 134 43884 7 64454707
Implant site infection 778.63 62.16 189 43829 1480 64453234
Menstrual disorder 638.43 62.16 187 43831 3178 64451536
Implant site irritation 630.62 62.16 103 43915 19 64454695
Medical device removal 609.44 62.16 128 43890 465 64454249
Device issue 600.17 62.16 298 43720 22350 64432364
Menstruation delayed 559.86 62.16 135 43883 1024 64453690
Mood swings 557.13 62.16 261 43757 17207 64437507
Menometrorrhagia 529.24 62.16 116 43902 540 64454174
Abortion spontaneous 486.46 62.16 268 43750 24875 64429839
Dysmenorrhoea 474.72 62.16 139 43879 2358 64452356
Polymenorrhoea 470.59 62.16 112 43906 798 64453916
Weight increased 457.47 62.16 641 43377 212707 64242007
Medical device site discomfort 447.73 62.16 81 43937 93 64454621
Implant site rash 427.81 62.16 75 43943 60 64454654
Hypomenorrhoea 407.36 62.16 84 43934 272 64454442
Menstruation normal 394.22 62.16 64 43954 9 64454705
Diarrhoea 368.03 62.16 35 43983 722669 63732045
Abortion induced 353.74 62.16 141 43877 6247 64448467
Device embolisation 346.25 62.16 58 43960 22 64454692
Pneumonia 340.75 62.16 9 44009 559567 63895147
Implant site hypoaesthesia 340.32 62.16 55 43963 6 64454708
Implant site reaction 327.73 62.16 61 43957 92 64454622
Death 308.99 62.16 4 44014 482701 63972013
Off label use 308.21 62.16 36 43982 632770 63821944
Implant site discharge 295.72 62.16 56 43962 98 64454616
Oligomenorrhoea 292.24 62.16 70 43948 514 64454200
Implant site mass 276.97 62.16 47 43971 23 64454691
Drug ineffective 272.86 62.16 117 43901 840130 63614584
Dyspnoea 269.16 62.16 79 43939 718595 63736119
Implant site cellulitis 265.71 62.16 46 43972 31 64454683
Surgery 262.26 62.16 189 43829 28024 64426690
Acute kidney injury 259.98 62.16 11 44007 449229 64005485
Implant site haemorrhage 259.07 62.16 53 43965 163 64454551
Pyrexia 252.40 62.16 40 43978 558604 63896110
Implant site paraesthesia 245.35 62.16 39 43979 0 64454714
Toxicity to various agents 228.25 62.16 4 44014 363509 64091205
Hypotension 221.45 62.16 9 44009 380965 64073749
Acne 204.01 62.16 150 43868 22931 64431783
Implant site vesicles 202.09 62.16 33 43985 6 64454708
Breast tenderness 197.58 62.16 68 43950 1981 64452733
Fall 197.03 62.16 26 43992 416800 64037914
Condition aggravated 194.57 62.16 16 44002 372410 64082304
Implant site warmth 188.71 62.16 31 43987 7 64454707
Implant site discolouration 183.26 62.16 30 43988 6 64454708
Implant site inflammation 182.68 62.16 40 43978 185 64454529
Mood altered 171.67 62.16 117 43901 15862 64438852
Implant site urticaria 165.27 62.16 27 43991 5 64454709
Implant site induration 157.27 62.16 25 43993 0 64454714
Expired product administered 156.18 62.16 78 43940 5909 64448805
Fatigue 153.02 62.16 172 43846 748558 63706156
Breast pain 152.46 62.16 81 43937 6980 64447734
Anaemia 150.08 62.16 37 43981 378643 64076071
Pain in extremity 150.04 62.16 501 43517 302584 64152130
Implant site abscess 147.64 62.16 26 43992 22 64454692
Haemorrhage 147.10 62.16 223 43795 79128 64375586
Arthralgia 145.56 62.16 60 43958 442200 64012514
Neutropenia 144.98 62.16 4 44014 239620 64215094
Confusional state 142.68 62.16 9 44009 261135 64193579
Wrong technique in device usage process 140.28 62.16 58 43960 2824 64451890
Cough 139.94 62.16 20 43998 302128 64152586
Incorrect route of product administration 138.56 62.16 120 43898 23178 64431536
General physical health deterioration 125.21 62.16 3 44015 204422 64250292
Application site discomfort 124.97 62.16 32 43986 318 64454396
Sepsis 122.71 62.16 9 44009 230332 64224382
Hypoaesthesia 122.54 62.16 284 43734 138824 64315890
Pregnancy on contraceptive 119.97 62.16 37 43981 754 64453960
Adverse event 119.42 62.16 141 43877 39348 64415366
Vomiting 116.37 62.16 123 43895 550994 63903720
Asthenia 114.33 62.16 76 43942 427968 64026746
Dehydration 113.96 62.16 9 44009 216754 64237960
Circumstance or information capable of leading to medication error 112.93 62.16 52 43966 3288 64451426
Drug hypersensitivity 109.47 62.16 16 44002 237799 64216915
Constipation 108.95 62.16 14 44004 229323 64225391
Haemoglobin decreased 108.71 62.16 6 44012 195057 64259657
Joint swelling 107.68 62.16 11 44007 215371 64239343
Oedema peripheral 104.48 62.16 11 44007 210306 64244408
Vaginal discharge 104.04 62.16 52 43966 3945 64450769
Drug intolerance 101.11 62.16 7 44011 187985 64266729
Atrial fibrillation 99.41 62.16 4 44014 171085 64283629
Nasopharyngitis 98.05 62.16 10 44008 196063 64258651
Rheumatoid arthritis 94.92 62.16 4 44014 164290 64290424
Implant site pustules 91.63 62.16 15 44003 3 64454711
Gait disturbance 90.89 62.16 7 44011 172148 64282566
Rash 90.52 62.16 108 43910 458441 63996273
Limb discomfort 90.51 62.16 102 43916 27073 64427641
Myocardial infarction 89.68 62.16 6 44012 165815 64288899
Ectopic pregnancy 88.24 62.16 35 43983 1529 64453185
Hypertension 87.09 62.16 34 43984 259227 64195487
Breast feeding 86.59 62.16 28 43990 669 64454045
Implant site oedema 86.12 62.16 15 44003 11 64454703
Somnolence 84.36 62.16 18 44000 203627 64251087
Hormone level abnormal 81.69 62.16 34 43984 1683 64453031
Sinusitis 79.73 62.16 5 44013 145923 64308791
Malaise 79.59 62.16 92 43926 396155 64058559
Medical device discomfort 78.19 62.16 32 43986 1517 64453197
Cardiac failure 77.21 62.16 3 44015 132370 64322344
Decreased appetite 73.60 62.16 51 43967 281238 64173476
Implant site hypersensitivity 71.81 62.16 13 44005 15 64454699
Hypokalaemia 70.30 62.16 3 44015 121900 64332814
Arthropathy 69.68 62.16 3 44015 120964 64333750
Encapsulation reaction 69.20 62.16 11 44007 0 64454714
Discomfort 68.83 62.16 163 43855 80715 64373999
Bradycardia 67.87 62.16 3 44015 118216 64336498
Pregnancy with contraceptive device 67.36 62.16 36 43982 3138 64451576
Pleural effusion 67.20 62.16 5 44013 126554 64328160
Alanine aminotransferase increased 67.18 62.16 8 44010 139023 64315691
Treatment failure 66.95 62.16 3 44015 116813 64337901
Tachycardia 66.67 62.16 11 44007 149568 64305146
Implant site haematoma 63.71 62.16 16 44002 146 64454568
Implant site nerve injury 62.91 62.16 10 44008 0 64454714

FDA Adverse Event Reporting System (Pediatric)

None

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 drugs
CHEBI has role CHEBI:49324 female contraceptive drugs
CHEBI has role CHEBI:59826 progestins

Drug Use | Suggest Off label Use Form| |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




๐Ÿถ Veterinary Drug Use

None

๐Ÿถ Veterinary products

None

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
Etonogestrel/Ethinyl Estradiol HUMAN PRESCRIPTION DRUG LABEL 2 50090-5959 INSERT, EXTENDED RELEASE 0.12 mg VAGINAL NDA AUTHORIZED GENERIC 29 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
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
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
NuvaRing HUMAN PRESCRIPTION DRUG LABEL 2 78206-146 INSERT, EXTENDED RELEASE 0.12 mg VAGINAL NDA 29 sections