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 21125.29 34.30 5655 73944 35750 63373673
Complication associated with device 17034.72 34.30 3994 75605 12984 63396439
Incorrect product administration duration 12170.02 34.30 2831 76768 8715 63400708
Device breakage 11821.19 34.30 2765 76834 8777 63400646
Product quality issue 11262.45 34.30 3363 76236 32502 63376921
Device difficult to use 10856.46 34.30 2633 76966 10163 63399260
Device deployment issue 10644.79 34.30 2097 77502 1805 63407618
Complication of device removal 10271.33 34.30 2132 77467 3010 63406413
Complication of device insertion 9505.87 34.30 2142 77457 5422 63404001
Pregnancy with implant contraceptive 8518.47 34.30 1638 77961 1045 63408378
Unintended pregnancy 8457.86 34.30 1877 77722 4302 63405121
Implant site pain 7419.74 34.30 1437 78162 1003 63408420
Device kink 6153.83 34.30 1195 78404 859 63408564
Device dislocation 5716.25 34.30 1855 77744 23850 63385573
Heavy menstrual bleeding 4690.02 34.30 1462 78137 16311 63393112
Menstruation irregular 4649.72 34.30 1186 78413 5818 63403605
Device expulsion 3947.17 34.30 1525 78074 33397 63376026
Intermenstrual bleeding 3415.98 34.30 954 78645 6972 63402451
Amenorrhoea 2728.61 34.30 843 78756 9071 63400352
Device placement issue 2356.85 34.30 501 79098 839 63408584
Vaginal haemorrhage 2324.07 34.30 975 78624 26512 63382911
Implant site erythema 2003.90 34.30 383 79216 220 63409203
Device issue 1825.73 34.30 788 78811 22993 63386430
Implant site pruritus 1776.72 34.30 347 79252 264 63409159
Implant site bruising 1442.26 34.30 268 79331 95 63409328
Implant site scar 1405.54 34.30 258 79341 69 63409354
Implant site infection 1401.30 34.30 311 79288 703 63408720
Implant site swelling 1339.25 34.30 266 79333 244 63409179
Implant site fibrosis 1207.63 34.30 215 79384 15 63409408
General anaesthesia 1128.03 34.30 200 79399 9 63409414
Uterine haemorrhage 836.92 34.30 277 79322 3764 63405659
Menstrual disorder 822.85 34.30 293 79306 5020 63404403
Implant site irritation 809.83 34.30 148 79451 35 63409388
Drug ineffective 743.72 34.30 199 79400 1044566 62364857
Menstruation delayed 720.95 34.30 203 79396 1526 63407897
Menometrorrhagia 716.02 34.30 180 79419 817 63408606
Medical device site discomfort 711.86 34.30 143 79456 147 63409276
Mood swings 691.84 34.30 373 79226 17875 63391548
Device embolisation 670.67 34.30 118 79481 0 63409423
Dysmenorrhoea 611.05 34.30 218 79381 3755 63405668
Diarrhoea 606.40 34.30 89 79510 715277 62694146
Polymenorrhoea 594.90 34.30 162 79437 1059 63408364
Abortion spontaneous 587.20 34.30 481 79118 46714 63362709
Implant site rash 570.77 34.30 108 79491 53 63409370
Abortion induced 532.31 34.30 259 79340 9983 63399440
Weight increased 499.43 34.30 1045 78554 259747 63149676
Implant site haemorrhage 488.70 34.30 90 79509 26 63409397
Medical device removal 483.19 34.30 139 79460 1138 63408285
Adverse event 482.45 34.30 505 79094 67054 63342369
Off label use 481.10 34.30 127 79472 674335 62735088
Implant site hypoaesthesia 480.15 34.30 85 79514 3 63409420
Hypomenorrhoea 469.70 34.30 115 79484 457 63408966
Menstruation normal 469.34 34.30 95 79504 105 63409318
Fatigue 461.10 34.30 273 79326 887755 62521668
Implant site reaction 454.47 34.30 88 79511 60 63409363
Pneumonia 438.88 34.30 36 79563 456731 62952692
Dyspnoea 422.15 34.30 152 79447 661161 62748262
Death 397.26 34.30 17 79582 374364 63035059
Condition aggravated 396.76 34.30 28 79571 402189 63007234
Implant site discharge 383.35 34.30 77 79522 79 63409344
Implant site cellulitis 369.36 34.30 66 79533 6 63409417
Arthralgia 361.54 34.30 132 79467 569578 62839845
Implant site paraesthesia 352.36 34.30 62 79537 0 63409423
Pyrexia 345.72 34.30 83 79516 470395 62939028
Implant site mass 334.91 34.30 61 79538 13 63409410
Surgery 327.79 34.30 307 79292 35605 63373818
Joint swelling 325.37 34.30 22 79577 327644 63081779
Implant site inflammation 325.21 34.30 70 79529 128 63409295
Wrong technique in device usage process 321.67 34.30 133 79466 3465 63405958
Oligomenorrhoea 314.71 34.30 91 79508 760 63408663
Fall 306.83 34.30 60 79539 392274 63017149
Drug intolerance 305.64 34.30 21 79578 308640 63100783
Expired product administered 302.33 34.30 150 79449 6031 63403392
Toxicity to various agents 289.18 34.30 4 79595 247246 63162177
Pregnancy with contraceptive device 281.45 34.30 131 79468 4563 63404860
Implant site discolouration 272.79 34.30 48 79551 0 63409423
Acute kidney injury 272.63 34.30 14 79585 263401 63146022
Rheumatoid arthritis 270.81 34.30 11 79588 253808 63155615
Circumstance or information capable of leading to medication error 260.32 34.30 117 79482 3753 63405670
Hypotension 260.07 34.30 22 79577 272582 63136841
Acne 255.71 34.30 221 79378 23072 63386351
Mood altered 252.91 34.30 182 79417 14561 63394862
Cough 250.47 34.30 35 79564 292708 63116715
Rash 248.31 34.30 204 79395 560667 62848756
Arthropathy 244.47 34.30 12 79587 234780 63174643
Drug hypersensitivity 243.87 34.30 47 79552 310640 63098783
Medical device discomfort 241.13 34.30 91 79508 1848 63407575
Abdominal discomfort 240.63 34.30 54 79545 320831 63088592
Implant site abscess 238.69 34.30 42 79557 0 63409423
Vomiting 236.21 34.30 213 79386 559404 62850019
Implant site vesicles 235.80 34.30 42 79557 3 63409420
Breast tenderness 234.50 34.30 94 79505 2256 63407167
Nasopharyngitis 233.25 34.30 24 79575 254233 63155190
Implant site warmth 227.42 34.30 41 79558 6 63409417
Treatment failure 225.37 34.30 5 79594 199038 63210385
Contraindicated product administered 214.78 34.30 15 79584 217633 63191790
General physical health deterioration 213.87 34.30 9 79590 201393 63208030
Confusional state 212.50 34.30 24 79575 236356 63173067
Implant site urticaria 209.54 34.30 38 79561 7 63409416
Pulmonary embolism 209.32 34.30 456 79143 116228 63293195
Systemic lupus erythematosus 204.41 34.30 15 79584 208903 63200520
Malaise 203.65 34.30 136 79463 415818 62993605
Hepatic enzyme increased 199.47 34.30 14 79585 202314 63207109
Implant site induration 198.91 34.30 35 79564 0 63409423
Sinusitis 198.82 34.30 25 79574 226628 63182795
Therapeutic product effect decreased 197.53 34.30 11 79588 193176 63216247
Neutropenia 195.79 34.30 5 79594 175000 63234423
Musculoskeletal stiffness 193.55 34.30 9 79590 184609 63224814
Anaemia 192.54 34.30 64 79535 293366 63116057
Haemorrhage 192.25 34.30 304 79295 60718 63348705
Asthenia 182.97 34.30 129 79470 383475 63025948
Vaginal discharge 177.39 34.30 122 79477 9076 63400347
Constipation 176.48 34.30 34 79565 224909 63184514
Gait disturbance 171.32 34.30 16 79583 183162 63226261
Thrombocytopenia 170.30 34.30 4 79595 151153 63258270
Completed suicide 167.51 34.30 3 79596 145670 63263753
Breast pain 165.69 34.30 115 79484 8683 63400740
Pregnancy on contraceptive 163.07 34.30 60 79539 1132 63408291
Hypertension 161.63 34.30 74 79525 279229 63130194
Stomatitis 158.93 34.30 3 79596 138722 63270701
Ectopic pregnancy 158.13 34.30 73 79526 2494 63406929
Inappropriate schedule of product administration 156.26 34.30 379 79220 103586 63305837
White blood cell count decreased 155.48 34.30 4 79595 139100 63270323
Application site discomfort 149.13 34.30 43 79556 355 63409068
Lower respiratory tract infection 147.14 34.30 4 79595 132303 63277120
Swelling 145.81 34.30 82 79517 275296 63134127
Pain 142.63 34.30 466 79133 740162 62669261
Therapeutic product effect incomplete 142.07 34.30 3 79596 125053 63284370
Dehydration 140.70 34.30 24 79575 173330 63236093
Alopecia 137.94 34.30 132 79467 337404 63072019
Decreased appetite 135.45 34.30 73 79526 250979 63158444
Device use issue 135.09 34.30 66 79533 2564 63406859
Implant site oedema 133.57 34.30 24 79575 3 63409420
Hypersensitivity 133.53 34.30 103 79496 292582 63116841
Platelet count decreased 131.07 34.30 3 79596 116119 63293304
Nausea 130.83 34.30 590 79009 853881 62555542
Oedema peripheral 130.20 34.30 38 79561 189473 63219950
Hormone level abnormal 126.61 34.30 62 79537 2421 63407002
Somnolence 126.15 34.30 34 79565 178651 63230772
Pruritus 126.10 34.30 161 79438 361292 63048131
Haemoglobin decreased 125.23 34.30 17 79582 145468 63263955
Urinary tract infection 124.78 34.30 90 79509 264594 63144829
Pain in extremity 123.72 34.30 774 78825 330712 63078711
Intentional product use issue 122.74 34.30 10 79589 127882 63281541
Atrial fibrillation 121.20 34.30 6 79593 116630 63292793
Incorrect route of product administration 120.37 34.30 160 79439 27292 63382131
Arthritis 120.33 34.30 6 79593 115915 63293508
Implant site injury 119.34 34.30 21 79578 0 63409423
Renal failure 119.29 34.30 7 79592 117645 63291778
Hyponatraemia 118.74 34.30 5 79594 111895 63297528
Implant site haematoma 117.97 34.30 26 79573 56 63409367
Wound 117.27 34.30 30 79569 163233 63246190
Deep vein thrombosis 116.93 34.30 297 79302 83503 63325920
Sepsis 116.19 34.30 25 79574 153098 63256325
Abnormal uterine bleeding 111.22 34.30 49 79550 1497 63407926
Product prescribing issue 110.21 34.30 58 79541 2641 63406782
Limb discomfort 109.07 34.30 159 79440 29557 63379866
Infection 106.60 34.30 79 79520 229094 63180329
Osteoarthritis 105.57 34.30 3 79596 95340 63314083
Gastrointestinal disorder 104.66 34.30 19 79580 131220 63278203
Maternal exposure before pregnancy 104.03 34.30 82 79517 7521 63401902
Blood pressure increased 103.34 34.30 37 79562 162025 63247398
Implant site hypersensitivity 102.49 34.30 20 79579 15 63409408
Implant site pustules 102.29 34.30 18 79581 0 63409423
Loss of personal independence in daily activities 97.99 34.30 6 79593 97284 63312139
Cardiac failure 97.98 34.30 3 79596 89139 63320284
C-reactive protein increased 97.98 34.30 5 79594 94702 63314721
Respiratory failure 97.63 34.30 8 79591 101850 63307573
Oxygen saturation decreased 97.30 34.30 3 79596 88582 63320841
Renal impairment 97.02 34.30 3 79596 88352 63321071
Breast feeding 94.70 34.30 37 79562 828 63408595
Ectopic pregnancy with contraceptive device 94.38 34.30 41 79558 1210 63408213
Psoriatic arthropathy 94.15 34.30 5 79594 91515 63317908
Bronchitis 93.56 34.30 21 79578 124914 63284509
Injection site pain 92.92 34.30 24 79575 129776 63279647
COVID-19 90.99 34.30 16 79583 113087 63296336
Encapsulation reaction 90.93 34.30 16 79583 0 63409423
Hypoaesthesia 90.90 34.30 435 79164 167958 63241465
Wheezing 90.28 34.30 8 79591 95587 63313836
Memory impairment 90.14 34.30 12 79587 104246 63305177
Blister 89.18 34.30 26 79573 129788 63279635
Blood cholesterol increased 88.45 34.30 8 79591 94024 63315399
Vulvovaginal discomfort 88.38 34.30 48 79551 2330 63407093
Keloid scar 87.51 34.30 25 79574 199 63409224
Neuropathy peripheral 87.36 34.30 18 79581 113649 63295774
Hypokalaemia 87.28 34.30 13 79586 103791 63305632
Dry mouth 84.23 34.30 3 79596 77860 63331563
Abnormal withdrawal bleeding 83.81 34.30 19 79580 49 63409374
Abortion 83.48 34.30 47 79552 2449 63406974
Needle issue 82.01 34.30 82 79517 10294 63399129
Insomnia 81.24 34.30 90 79509 215162 63194261
Scar 80.84 34.30 93 79506 13689 63395734
Alanine aminotransferase increased 80.65 34.30 16 79583 103754 63305669
Herpes zoster 80.37 34.30 6 79593 82456 63326967
Tremor 79.64 34.30 33 79566 132206 63277217
Dysphagia 79.51 34.30 9 79590 88576 63320847
Bradycardia 78.59 34.30 3 79596 73224 63336199
Hospitalisation 78.01 34.30 8 79591 85073 63324350
Cardiac arrest 76.87 34.30 12 79587 92533 63316890
Asthma 76.54 34.30 32 79567 127529 63281894
Influenza 76.12 34.30 21 79578 108701 63300722
Therapy non-responder 75.48 34.30 5 79594 75896 63333527
Aspartate aminotransferase increased 74.32 34.30 12 79587 90265 63319158
Oedema 73.91 34.30 16 79583 97606 63311817
Withdrawal bleed 73.87 34.30 17 79582 48 63409375
Myocardial infarction 72.40 34.30 18 79581 99875 63309548
Peripheral swelling 72.17 34.30 140 79459 265802 63143621
Chills 72.06 34.30 26 79573 113352 63296071
Ill-defined disorder 71.66 34.30 9 79590 81746 63327677
Dyspepsia 71.06 34.30 20 79579 102176 63307247
Mobility decreased 68.61 34.30 33 79566 121126 63288297
Implant site nerve injury 68.20 34.30 12 79587 0 63409423
Fibromyalgia 67.77 34.30 10 79589 80410 63329013
Tachycardia 67.19 34.30 32 79567 118124 63291299
Productive cough 66.46 34.30 3 79596 63205 63346218
Psoriasis 66.34 34.30 14 79585 86943 63322480
Drug abuse 66.02 34.30 7 79592 72511 63336912
Device failure 65.88 34.30 57 79542 5954 63403469
Balance disorder 65.64 34.30 13 79586 84409 63325014
Irritable bowel syndrome 65.54 34.30 12 79587 82400 63327023
Libido decreased 65.05 34.30 41 79558 2631 63406792
Interstitial lung disease 64.89 34.30 3 79596 61905 63347518
Septic shock 64.50 34.30 5 79594 66624 63342799
Intentional overdose 63.00 34.30 9 79590 74143 63335280
Administration site discomfort 62.69 34.30 16 79583 78 63409345
Hypoglycaemia 62.67 34.30 3 79596 60062 63349361
Cardio-respiratory arrest 62.54 34.30 3 79596 59956 63349467
Ulnar nerve injury 62.49 34.30 18 79581 148 63409275
Depressed level of consciousness 61.99 34.30 4 79595 62074 63347349
Infertility female 61.51 34.30 24 79575 535 63408888
Heart rate increased 60.93 34.30 21 79578 94217 63315206
Nasal congestion 60.64 34.30 6 79593 65654 63343769
Wrong technique in product usage process 60.61 34.30 194 79405 62146 63347277
Osteoporosis 59.39 34.30 3 79596 57335 63352088
Lung disorder 59.35 34.30 5 79594 62256 63347167
Coma 59.14 34.30 6 79593 64358 63345065
Cataract 59.05 34.30 3 79596 57050 63352373
Blood glucose increased 58.96 34.30 16 79583 83740 63325683
Pelvic pain 58.04 34.30 78 79521 13441 63395982
Ruptured ectopic pregnancy 57.96 34.30 22 79577 454 63408969
Medical device site scab 56.83 34.30 10 79589 0 63409423
Myalgia 56.67 34.30 60 79539 146469 63262954
Product administration error 56.40 34.30 101 79498 22296 63387127
Gastrooesophageal reflux disease 55.77 34.30 25 79574 95614 63313809
Rhinorrhoea 55.61 34.30 8 79591 65569 63343854
Emotional disorder 54.12 34.30 75 79524 13304 63396119
Incorrect dose administered 54.05 34.30 6 79593 59962 63349461
Type 2 diabetes mellitus 53.68 34.30 8 79591 63860 63345563
Upper respiratory tract infection 53.54 34.30 18 79581 82029 63327394
Pleural effusion 53.36 34.30 25 79574 93185 63316238
Sleep disorder 53.04 34.30 18 79581 81548 63327875
Ovarian cyst 52.35 34.30 81 79518 15864 63393559
Adnexa uteri pain 52.19 34.30 20 79579 424 63408999
Cognitive disorder 51.81 34.30 5 79594 55810 63353613
Oropharyngeal pain 51.59 34.30 27 79572 94460 63314963
Delirium 51.24 34.30 3 79596 50538 63358885
Implant site nodule 51.15 34.30 9 79590 0 63409423
Implant site necrosis 51.15 34.30 9 79590 0 63409423
Poor quality device used 50.97 34.30 32 79567 2039 63407384
Blood pressure decreased 50.57 34.30 10 79589 65012 63344411
Bone pain 50.44 34.30 5 79594 54636 63354787
Flushing 49.82 34.30 16 79583 75071 63334352
Anaphylactic reaction 49.69 34.30 11 79588 66089 63343334
Inflammation 48.77 34.30 21 79578 82252 63327171
Coital bleeding 48.68 34.30 20 79579 512 63408911
Gait inability 48.49 34.30 5 79594 52954 63356469
Chlamydial infection 48.27 34.30 18 79581 353 63409070
Hallucination 48.12 34.30 6 79593 54811 63354612
Injection site erythema 48.09 34.30 22 79577 83152 63326271
Dyspnoea exertional 47.48 34.30 9 79590 60293 63349130
Suppressed lactation 47.35 34.30 19 79580 457 63408966
Product shape issue 47.21 34.30 13 79586 89 63409334
Liver disorder 46.83 34.30 6 79593 53681 63355742
Fluid retention 46.80 34.30 9 79590 59677 63349746
Unwanted pregnancy 46.61 34.30 12 79587 61 63409362
Premenstrual syndrome 46.02 34.30 21 79578 698 63408725
Chest discomfort 46.01 34.30 42 79557 109927 63299496
Multiple sclerosis relapse 45.92 34.30 4 79595 48474 63360949
Erythema 45.52 34.30 95 79504 175656 63233767
Implant site cyst 45.46 34.30 8 79591 0 63409423
Intentional product misuse 44.09 34.30 11 79588 60906 63348517
Red blood cell sedimentation rate increased 43.43 34.30 3 79596 43979 63365444
Colitis 43.37 34.30 5 79594 48523 63360900
Agitation 42.84 34.30 11 79588 59746 63349677
Liposuction 42.34 34.30 9 79590 15 63409408
Muscular weakness 42.05 34.30 55 79544 122298 63287125
Adverse drug reaction 41.74 34.30 24 79575 79690 63329733
Hyperhidrosis 40.75 34.30 45 79554 107791 63301632
Pain in jaw 40.10 34.30 4 79595 43492 63365931
Implant site papules 39.78 34.30 7 79592 0 63409423
Ascites 39.57 34.30 3 79596 40725 63368698
Epistaxis 39.38 34.30 21 79578 72704 63336719
Rectal haemorrhage 39.28 34.30 7 79592 49023 63360400
Therapeutic response decreased 39.27 34.30 14 79585 61511 63347912
Circumstance or information capable of leading to device use error 38.88 34.30 12 79587 128 63409295
White blood cell count increased 38.76 34.30 7 79592 48554 63360869
Hypercoagulation 38.66 34.30 27 79572 2058 63407365
Diabetes mellitus 38.64 34.30 11 79588 55799 63353624
International normalised ratio increased 38.59 34.30 6 79593 46419 63363004
Mental status changes 38.24 34.30 3 79596 39596 63369827
Overdose 38.08 34.30 261 79338 114817 63294606
Vaginal infection 37.95 34.30 47 79552 7471 63401952
Haematocrit decreased 37.94 34.30 3 79596 39337 63370086
Implantation complication 37.76 34.30 8 79591 13 63409410
Haematochezia 36.25 34.30 11 79588 53533 63355890
Liver function test abnormal 36.25 34.30 8 79591 48173 63361250
Injection site reaction 36.21 34.30 14 79585 58510 63350913
Blood potassium decreased 35.93 34.30 5 79594 42021 63367402
Injection site bruising 35.80 34.30 5 79594 41905 63367518
Product quality control issue 35.47 34.30 8 79591 20 63409403
Illness 35.23 34.30 9 79590 49050 63360373
Blood alkaline phosphatase increased 34.72 34.30 6 79593 42961 63366462
Musculoskeletal pain 34.32 34.30 39 79560 92238 63317185

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 13244.22 41.50 3356 49839 33836 79657357
Complication associated with device 10966.50 41.50 2496 50699 15000 79676193
Product quality issue 8601.27 41.50 2343 50852 31597 79659596
Device difficult to use 8419.41 41.50 1917 51278 11468 79679725
Device deployment issue 8277.88 41.50 1489 51706 1723 79689470
Complication of device insertion 7613.80 41.50 1548 51647 4802 79686391
Complication of device removal 7390.53 41.50 1394 51801 2495 79688698
Device breakage 7334.96 41.50 1644 51551 9031 79682162
Incorrect product administration duration 7097.66 41.50 1636 51559 10386 79680807
Implant site pain 6046.76 41.50 1070 52125 1027 79690166
Unintended pregnancy 5775.13 41.50 1136 52059 2797 79688396
Pregnancy with implant contraceptive 5698.16 41.50 999 52196 857 79690336
Device kink 4206.26 41.50 775 52420 1120 79690073
Device dislocation 4177.62 41.50 1261 51934 24709 79666484
Heavy menstrual bleeding 3842.05 41.50 1032 52163 12979 79678214
Device expulsion 3469.85 41.50 1093 52102 24768 79666425
Menstruation irregular 3304.02 41.50 748 52447 4288 79686905
Intermenstrual bleeding 2817.95 41.50 677 52518 5207 79685986
Amenorrhoea 2452.83 41.50 639 52556 7053 79684140
Device placement issue 1894.14 41.50 369 52826 838 79690355
Implant site erythema 1717.55 41.50 300 52895 242 79690951
Vaginal haemorrhage 1671.66 41.50 606 52589 21211 79669982
Implant site pruritus 1619.17 41.50 282 52913 219 79690974
Implant site bruising 1188.09 41.50 200 52995 91 79691102
Implant site swelling 1100.94 41.50 201 52994 264 79690929
Implant site scar 1022.64 41.50 171 53024 68 79691125
Device issue 1009.83 41.50 448 52747 26660 79664533
Implant site fibrosis 1006.99 41.50 161 53034 10 79691183
General anaesthesia 918.59 41.50 147 53048 10 79691183
Implant site infection 878.96 41.50 212 52983 1653 79689540
Menstrual disorder 684.72 41.50 205 52990 3862 79687331
Implant site irritation 683.36 41.50 111 53084 19 79691174
Menstruation delayed 630.56 41.50 154 53041 1272 79689921
Medical device removal 625.95 41.50 134 53061 561 79690632
Abortion spontaneous 595.67 41.50 321 52874 29186 79662007
Mood swings 587.91 41.50 280 52915 19600 79671593
Menometrorrhagia 559.72 41.50 123 53072 597 79690596
Dysmenorrhoea 536.55 41.50 159 53036 2886 79688307
Medical device site discomfort 530.09 41.50 97 53098 130 79691063
Abortion induced 523.66 41.50 192 53003 6917 79684276
Polymenorrhoea 498.46 41.50 119 53076 883 79690310
Implant site rash 464.88 41.50 81 53114 63 79691130
Hypomenorrhoea 423.24 41.50 89 53106 335 79690858
Weight increased 413.57 41.50 696 52499 276690 79414503
Device embolisation 412.89 41.50 69 53126 27 79691166
Menstruation normal 409.51 41.50 67 53128 15 79691178
Diarrhoea 386.31 41.50 63 53132 880426 78810767
Off label use 384.74 41.50 71 53124 907144 78784049
Pneumonia 354.16 41.50 22 53173 660224 79030969
Implant site hypoaesthesia 347.88 41.50 56 53139 6 79691187
Implant site reaction 343.93 41.50 64 53131 100 79691093
Death 336.55 41.50 9 53186 566505 79124688
Drug ineffective 335.48 41.50 152 53043 1080761 78610432
Implant site discharge 332.77 41.50 63 53132 114 79691079
Implant site haemorrhage 314.16 41.50 63 53132 175 79691018
Implant site mass 296.78 41.50 50 53145 23 79691170
Implant site cellulitis 295.49 41.50 53 53142 58 79691135
Acute kidney injury 295.18 41.50 12 53183 519392 79171801
Oligomenorrhoea 288.66 41.50 72 53123 654 79690539
Pyrexia 277.04 41.50 58 53137 678651 79012542
Dyspnoea 274.25 41.50 115 53080 856910 78834283
Surgery 271.59 41.50 203 52992 32563 79658630
Pregnancy with contraceptive device 262.85 41.50 97 53098 3557 79687636
Toxicity to various agents 260.91 41.50 4 53191 421536 79269657
Implant site paraesthesia 258.86 41.50 41 53154 0 79691193
Condition aggravated 242.78 41.50 26 53169 501098 79190095
Hypotension 240.94 41.50 13 53182 440304 79250889
Implant site inflammation 235.67 41.50 51 53144 227 79690966
Wrong technique in device usage process 214.82 41.50 86 53109 3942 79687251
Breast tenderness 211.54 41.50 73 53122 2195 79688998
Fall 210.83 41.50 36 53159 487593 79203600
Implant site warmth 208.30 41.50 34 53161 7 79691186
Implant site vesicles 202.84 41.50 33 53162 6 79691187
Acne 198.01 41.50 156 53039 27034 79664159
Medical device discomfort 197.34 41.50 65 53130 1689 79689504
Implant site discolouration 190.24 41.50 31 53164 6 79691187
Fatigue 189.89 41.50 205 52990 929522 78761671
Mood altered 188.04 41.50 128 53067 17719 79673474
Implant site urticaria 176.03 41.50 29 53166 8 79691185
Neutropenia 172.77 41.50 4 53191 287706 79403487
Arthralgia 171.17 41.50 84 53111 571719 79119474
Vaginal discharge 166.93 41.50 87 53108 7376 79683817
Breast pain 166.92 41.50 90 53105 8175 79683018
Expired product administered 165.78 41.50 85 53110 6966 79684227
Implant site induration 164.15 41.50 26 53169 0 79691193
Thrombocytopenia 162.00 41.50 3 53192 265256 79425937
Anaemia 160.17 41.50 49 53146 444966 79246227
Pregnancy on contraceptive 157.79 41.50 47 53148 868 79690325
Implant site abscess 155.46 41.50 28 53167 32 79691161
Haemorrhage 154.84 41.50 243 52952 90875 79600318
Cough 154.27 41.50 29 53166 366760 79324433
Ectopic pregnancy 150.62 41.50 53 53142 1690 79689503
General physical health deterioration 147.75 41.50 9 53186 275229 79415964
Pain in extremity 146.25 41.50 554 52641 363984 79327209
Confusional state 142.90 41.50 21 53174 317976 79373217
Joint swelling 137.04 41.50 16 53179 288630 79402563
Drug intolerance 134.93 41.50 11 53184 264108 79427085
Hypoaesthesia 134.17 41.50 339 52856 179013 79512180
Sepsis 127.73 41.50 15 53180 269413 79421780
Application site discomfort 123.25 41.50 32 53163 346 79690847
Asthenia 120.35 41.50 99 53096 511590 79179603
Constipation 119.78 41.50 22 53173 283028 79408165
Dehydration 119.70 41.50 13 53182 248174 79443019
Vomiting 119.52 41.50 162 53033 665666 79025527
Circumstance or information capable of leading to medication error 117.85 41.50 56 53139 3892 79687301
Renal failure 116.17 41.50 4 53191 200964 79490229
Platelet count decreased 115.70 41.50 3 53192 194661 79496532
Implant site oedema 115.67 41.50 20 53175 14 79691179
Drug hypersensitivity 114.76 41.50 29 53166 298887 79392306
Rheumatoid arthritis 114.37 41.50 6 53189 208464 79482729
Pulmonary embolism 113.61 41.50 310 52885 171344 79519849
Nasopharyngitis 113.50 41.50 17 53178 253864 79437329
White blood cell count decreased 111.54 41.50 3 53192 188285 79502908
Inappropriate schedule of product administration 110.98 41.50 263 52932 133365 79557828
Haemoglobin decreased 108.74 41.50 11 53184 222108 79469085
Atrial fibrillation 107.61 41.50 6 53189 197880 79493313
Rash 105.48 41.50 139 53056 578219 79112974
Malaise 105.33 41.50 103 53092 489766 79201427
Hyponatraemia 104.73 41.50 3 53192 177845 79513348
Incorrect route of product administration 103.37 41.50 122 53073 34807 79656386
Implant site injury 101.02 41.50 16 53179 0 79691193
Sinusitis 97.49 41.50 9 53186 195492 79495701
Arthropathy 97.45 41.50 5 53190 177106 79514087
Gait disturbance 97.23 41.50 12 53183 207494 79483699
Hypertension 96.81 41.50 50 53145 330942 79360251
Respiratory failure 96.80 41.50 6 53189 180905 79510288
Drug abuse 94.87 41.50 3 53192 162688 79528505
Decreased appetite 93.97 41.50 56 53139 342362 79348831
Treatment failure 93.22 41.50 5 53190 170481 79520712
Oedema peripheral 92.08 41.50 27 53168 252261 79438932
Somnolence 92.06 41.50 23 53172 238958 79452235
Implant site pustules 91.97 41.50 15 53180 3 79691190
Renal impairment 91.68 41.50 3 53192 157780 79533413
Cardiac failure 89.77 41.50 3 53192 154839 79536354
Cardiac arrest 88.33 41.50 7 53188 172089 79519104
Breast feeding 86.63 41.50 28 53167 684 79690509
Limb discomfort 86.25 41.50 108 53087 32742 79658451
Therapeutic product effect decreased 85.99 41.50 6 53189 163857 79527336
Adverse event 85.29 41.50 148 53047 60066 79631127
Musculoskeletal stiffness 84.79 41.50 9 53186 174999 79516194
Hepatic enzyme increased 84.48 41.50 11 53184 182599 79508594
Hormone level abnormal 83.94 41.50 36 53159 1966 79689227
Myocardial infarction 83.03 41.50 12 53183 184117 79507076
Implant site hypersensitivity 82.89 41.50 15 53180 18 79691175
Encapsulation reaction 82.07 41.50 13 53182 0 79691193
Bradycardia 77.28 41.50 3 53192 135554 79555639
Vulvovaginal discomfort 76.89 41.50 33 53162 1805 79689388
Hypokalaemia 76.38 41.50 5 53190 144035 79547158
Intentional product use issue 75.84 41.50 7 53188 152105 79539088
Ectopic pregnancy with contraceptive device 75.08 41.50 28 53167 1057 79690136
COVID-19 74.14 41.50 9 53186 157665 79533528
Implant site haematoma 73.22 41.50 18 53177 153 79691040
C-reactive protein increased 73.07 41.50 3 53192 129024 79562169
Contraindicated product administered 71.65 41.50 10 53185 157528 79533665
Maternal exposure before pregnancy 70.29 41.50 41 53154 4332 79686861
Implant site nerve injury 69.45 41.50 11 53184 0 79691193
Adnexa uteri pain 69.25 41.50 20 53175 330 79690863
Alanine aminotransferase increased 67.95 41.50 13 53182 162557 79528636
Device use issue 66.72 41.50 34 53161 2750 79688443
Blood pressure increased 66.25 41.50 29 53166 211331 79479862
Abdominal discomfort 65.99 41.50 43 53152 250684 79440509
Septic shock 65.90 41.50 4 53191 122797 79568396
Withdrawal bleed 65.39 41.50 13 53182 34 79691159
Abnormal uterine bleeding 64.55 41.50 25 53170 1048 79690145
Arthritis 63.96 41.50 3 53192 114877 79576316
Abnormal withdrawal bleeding 63.35 41.50 13 53182 42 79691151
Dysphagia 62.57 41.50 5 53190 122131 79569062
Scar 62.26 41.50 63 53132 15133 79676060
Neuropathy peripheral 61.89 41.50 10 53185 141295 79549898
Tachycardia 61.32 41.50 21 53174 177747 79513446
Needle issue 60.66 41.50 58 53137 13010 79678183
Ovarian cyst 60.33 41.50 57 53138 12598 79678595
Aspartate aminotransferase increased 60.30 41.50 10 53185 138631 79552562
Infection 60.23 41.50 44 53151 241668 79449525
Product administration error 59.79 41.50 89 53106 31757 79659436
Systemic lupus erythematosus 59.27 41.50 6 53189 121143 79570050
Wheezing 59.15 41.50 5 53190 116659 79574534
Device failure 59.13 41.50 42 53153 6219 79684974
Urinary tract infection 58.58 41.50 58 53137 274454 79416739
Deep vein thrombosis 57.92 41.50 195 53000 120724 79570469
Chills 56.90 41.50 18 53177 160216 79530977
Loss of personal independence in daily activities 56.09 41.50 3 53192 102577 79588616
Abortion 54.69 41.50 24 53171 1386 79689807
Pleural effusion 52.14 41.50 16 53179 145246 79545947
Premenstrual syndrome 51.94 41.50 18 53177 548 79690645
Keloid scar 51.49 41.50 14 53181 183 79691010
Bronchitis 51.41 41.50 12 53183 130632 79560561
Administration site discomfort 51.26 41.50 13 53182 127 79691066
Hospitalisation 50.77 41.50 3 53192 94233 79596960
Implant site nodule 50.51 41.50 8 53187 0 79691193
Therapy non-responder 49.54 41.50 3 53192 92302 79598891
Coma 49.19 41.50 5 53190 100644 79590549
Ulnar nerve injury 48.99 41.50 13 53182 154 79691039
Paraesthesia 48.93 41.50 240 52955 176083 79515110
Gastrooesophageal reflux disease 48.88 41.50 6 53189 104240 79586953
Memory impairment 48.72 41.50 8 53187 111726 79579467
Suppressed lactation 48.68 41.50 15 53180 312 79690881
Ruptured ectopic pregnancy 48.60 41.50 16 53179 415 79690778
Gastrointestinal disorder 48.53 41.50 11 53184 122194 79568999
Blood pressure decreased 48.46 41.50 5 53190 99461 79591732
Infertility female 47.95 41.50 16 53179 433 79690760
Tremor 47.77 41.50 27 53168 170056 79521137
Intentional overdose 47.54 41.50 7 53188 105953 79585240
Productive cough 47.02 41.50 3 53192 88328 79602865
Unwanted pregnancy 46.62 41.50 9 53186 19 79691174
Osteoarthritis 46.37 41.50 3 53192 87306 79603887
Uterine haemorrhage 46.09 41.50 27 53168 2876 79688317
Emotional disorder 45.48 41.50 52 53143 14335 79676858
Migraine 45.39 41.50 145 53050 87348 79603845
Asthma 44.81 41.50 17 53178 135078 79556115
Delirium 44.68 41.50 3 53192 84624 79606569
Discomfort 44.62 41.50 184 53011 125433 79565760
Herpes zoster 44.53 41.50 5 53190 93078 79598115
Pelvic pain 43.38 41.50 49 53146 13332 79677861
Intentional product misuse 43.36 41.50 6 53189 95159 79596034
Hallucination 42.58 41.50 4 53191 85741 79605452
Blood glucose increased 42.48 41.50 12 53183 114963 79576230
International normalised ratio increased 41.95 41.50 4 53191 84717 79606476

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
MeSH PA D003270 Contraceptive Agents
MeSH PA D003271 Contraceptive Agents, Female
MeSH PA D000080066 Contraceptive Agents, Hormonal
MeSH PA D012102 Reproductive Control Agents
FDA EPC N0000175602 Progestin
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
DB00294 DRUGBANK_ID
CHEMBL1697750 ChEMBL_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
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 28 sections
NUVARING HUMAN PRESCRIPTION DRUG LABEL 2 50090-5611 INSERT, EXTENDED RELEASE 0.12 mg VAGINAL NDA 28 sections
Etonogestrel/Ethinyl Estradiol HUMAN PRESCRIPTION DRUG LABEL 2 50090-5959 INSERT, EXTENDED RELEASE 0.12 mg VAGINAL NDA AUTHORIZED GENERIC 29 sections
HALOETTE HUMAN PRESCRIPTION DRUG LABEL 2 51862-148 INSERT, EXTENDED RELEASE 0.12 mg VAGINAL ANDA 34 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
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
EnilloRing HUMAN PRESCRIPTION DRUG LABEL 2 70700-156 RING 0.12 mg VAGINAL ANDA 22 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
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
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