levonorgestrel ๐Ÿถ Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
steroids, progestogens 1572 797-63-7

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • levonorgestrel
  • 18-Methylnorethindrone
  • D-Norgestrel
  • dexnorgestrel
  • norgestrel
A synthetic progestational hormone with actions similar to those of PROGESTERONE and about twice as potent as its racemic or (+-)-isomer (NORGESTREL). It is used for contraception, control of menstrual disorders, and treatment of endometriosis.
  • Molecular weight: 312.45
  • Formula: C21H28O2
  • CLOGP: 3.32
  • LIPINSKI: 0
  • HAC: 2
  • HDO: 1
  • TPSA: 37.30
  • ALOGS: -4.73
  • ROTB: 1

  • Status: OFP

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

Drug dosage:

DoseUnitRoute
1.50 mg O

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 2 Bocci G, Oprea TI, Benet LZ
S (Water solubility) 0.01 mg/mL Bocci G, Oprea TI, Benet LZ
EoM (Fraction excreted unchanged in urine) 52 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 0.03 ยตM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 94 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution) 1.50 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 1.80 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.03 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 9.40 hours Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
April 16, 1968 FDA WYETH PHARMS
July 2, 2018 PMDA Nobelpharma Co., Ltd.

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
Device expulsion 125769.89 23.99 26185 131179 8737 63322921
Device dislocation 39315.79 23.99 9681 147683 16024 63315634
Genital haemorrhage 20358.42 23.99 4495 152869 2837 63328821
Uterine perforation 15528.32 23.99 3571 153793 3392 63328266
Pregnancy with contraceptive device 14071.41 23.99 3067 154297 1627 63330031
Complication of device insertion 11135.57 23.99 2775 154589 4789 63326869
Procedural pain 10699.66 23.99 3374 153990 18195 63313463
Abdominal pain lower 9735.51 23.99 3277 154087 22401 63309257
Embedded device 7798.69 23.99 1794 155570 1689 63329969
Pelvic pain 6911.75 23.99 2166 155198 11353 63320305
Vaginal haemorrhage 6420.42 23.99 2452 154912 25035 63306623
Complication associated with device 6127.56 23.99 2090 155274 14888 63316770
Device difficult to use 5604.68 23.99 1823 155541 10973 63320685
Device breakage 5183.38 23.99 1676 155688 9866 63321792
Ectopic pregnancy with contraceptive device 4840.26 23.99 1010 156354 241 63331417
Complication of device removal 4790.80 23.99 1313 156051 3829 63327829
Device use issue 4219.73 23.99 1035 156329 1595 63330063
Heavy menstrual bleeding 3945.44 23.99 1529 155835 16244 63315414
Medical device discomfort 3769.53 23.99 891 156473 1048 63330610
Uterine rupture 3635.17 23.99 778 156586 308 63331350
Post procedural discomfort 3463.46 23.99 751 156613 363 63331295
Device issue 3394.58 23.99 1492 155872 22289 63309369
Medical device pain 3149.62 23.99 741 156623 839 63330819
Amenorrhoea 2973.32 23.99 1064 156300 8850 63322808
Injury 2528.35 23.99 1804 155560 71443 63260215
Dyspareunia 2431.10 23.99 658 156706 1797 63329861
Expired device used 1958.89 23.99 412 156952 117 63331541
Post procedural haemorrhage 1916.11 23.99 727 156637 7237 63324421
Emotional distress 1902.53 23.99 1117 156247 31432 63300226
Uterine spasm 1610.26 23.99 367 156997 314 63331344
Unintentional medical device removal 1590.27 23.99 591 156773 5524 63326134
Abdominal pain 1550.76 23.99 2677 154687 290779 63040879
Device deployment issue 1522.73 23.99 510 156854 3392 63328266
Loss of libido 1441.34 23.99 384 156980 965 63330693
Intermenstrual bleeding 1397.28 23.99 578 156786 7348 63324310
Ovarian cyst 1253.03 23.99 665 156699 15280 63316378
Diarrhoea 1187.19 23.99 181 157183 715185 62616473
Ruptured ectopic pregnancy 1182.05 23.99 267 157097 209 63331449
Procedural haemorrhage 1175.85 23.99 383 156981 2305 63329353
Haemorrhage in pregnancy 1171.42 23.99 353 157011 1572 63330086
Menstruation irregular 1091.74 23.99 468 156896 6536 63325122
Off label use of device 1076.46 23.99 230 157134 88 63331570
Dysmenorrhoea 1033.05 23.99 384 156980 3589 63328069
Uterine cervix stenosis 1021.08 23.99 214 157150 56 63331602
Device physical property issue 1008.66 23.99 318 157046 1694 63329964
Intentional device misuse 983.13 23.99 255 157109 553 63331105
Vaginal discharge 978.71 23.99 471 156893 8727 63322931
Pneumonia 939.36 23.99 47 157317 456720 62874938
Uterine haemorrhage 900.64 23.99 349 157015 3692 63327966
Coital bleeding 891.89 23.99 217 157147 315 63331343
Dyspnoea 879.17 23.99 275 157089 661038 62670620
Death 826.24 23.99 22 157342 374359 62957299
Pelvic inflammatory disease 805.46 23.99 256 157108 1406 63330252
Ectopic pregnancy 793.80 23.99 282 157082 2285 63329373
Depression 770.29 23.99 1580 155784 194912 63136746
Contraindicated device used 760.46 23.99 152 157212 0 63331658
Medical device monitoring error 755.46 23.99 151 157213 0 63331658
Fall 707.84 23.99 75 157289 392259 62939399
Uterine leiomyoma 703.90 23.99 377 156987 8821 63322837
Internal injury 682.78 23.99 161 157203 185 63331473
Anxiety 681.98 23.99 1599 155765 215942 63115716
Acne 679.16 23.99 519 156845 22774 63308884
Drug intolerance 636.38 23.99 31 157333 308630 63023028
Hypomenorrhoea 630.91 23.99 167 157197 405 63331253
Joint swelling 627.43 23.99 49 157315 327617 63004041
Drug hypersensitivity 598.95 23.99 45 157319 310642 63021016
Condition aggravated 586.43 23.99 139 157225 402078 62929580
Idiopathic intracranial hypertension 582.47 23.99 233 157131 2698 63328960
Acute kidney injury 571.55 23.99 18 157346 263397 63068261
Toxicity to various agents 562.84 23.99 10 157354 247240 63084418
Infusion related reaction 550.57 23.99 12 157352 245509 63086149
Rash 549.90 23.99 358 157006 560513 62771145
Libido decreased 543.47 23.99 216 157148 2456 63329202
Arthropathy 516.80 23.99 14 157350 234778 63096880
Rheumatoid arthritis 508.97 23.99 30 157334 253789 63077869
Abortion spontaneous 506.90 23.99 605 156759 46590 63285068
Fatigue 498.03 23.99 904 156460 887124 62444534
Breast tenderness 495.56 23.99 195 157169 2155 63329503
Infertility female 493.81 23.99 137 157227 422 63331236
Arthralgia 483.52 23.99 422 156942 569288 62762370
Breast cancer female 476.11 23.99 338 157026 13221 63318437
Uterine pain 469.04 23.99 116 157248 188 63331470
Nasopharyngitis 467.52 23.99 45 157319 254212 63077446
Menstrual disorder 464.20 23.99 238 157126 5075 63326583
Intra-uterine contraceptive device removal 464.00 23.99 95 157269 12 63331646
Cough 453.24 23.99 88 157276 292655 63039003
Contraindicated product administered 447.93 23.99 22 157342 217626 63114032
Device placement issue 444.07 23.99 155 157209 1185 63330473
Device use error 443.23 23.99 237 157127 5524 63326134
Pemphigus 437.97 23.99 3 157361 183723 63147935
Therapeutic product effect decreased 434.77 23.99 9 157355 193178 63138480
Swelling 434.36 23.99 79 157285 275299 63056359
Cervical dysplasia 430.26 23.99 193 157171 3021 63328637
Confusional state 428.91 23.99 44 157320 236336 63095322
Vomiting 428.80 23.99 454 156910 559163 62772495
Systemic lupus erythematosus 427.12 23.99 22 157342 208896 63122762
Mood swings 426.10 23.99 357 157007 17891 63313767
Hypotension 423.98 23.99 81 157283 272523 63059135
Menometrorrhagia 423.67 23.99 139 157225 858 63330800
Treatment failure 416.47 23.99 18 157346 199025 63132633
Peripheral swelling 415.77 23.99 78 157286 265864 63065794
Product dose omission issue 414.00 23.99 48 157316 234265 63097393
Menstruation delayed 401.94 23.99 154 157210 1575 63330083
Pyrexia 394.62 23.99 352 157012 470126 62861532
Hypersensitivity 392.51 23.99 119 157245 292566 63039092
Breast pain 391.58 23.99 254 157110 8544 63323114
Haemoperitoneum 387.47 23.99 171 157193 2570 63329088
Off label use 386.84 23.99 676 156688 673786 62657872
Device defective 386.51 23.99 155 157209 1807 63329851
Neutropenia 382.92 23.99 11 157353 174994 63156664
Sinusitis 382.13 23.99 54 157310 226599 63105059
Anaemia 379.81 23.99 127 157237 293303 63038355
Wound 369.77 23.99 7 157357 163256 63168402
Hepatic enzyme increased 363.57 23.99 39 157325 202289 63129369
Nausea 355.06 23.99 1022 156342 853449 62478209
Decreased appetite 340.31 23.99 100 157264 250952 63080706
Hypertension 323.13 23.99 144 157220 279159 63052499
Stomatitis 322.40 23.99 4 157360 138721 63192937
Dehydration 320.33 23.99 30 157334 173324 63158334
Malaise 316.45 23.99 339 157025 415615 62916043
Abdominal discomfort 309.47 23.99 208 157156 320677 63010981
Musculoskeletal stiffness 308.77 23.99 45 157319 184573 63147085
Pericarditis 304.86 23.99 4 157360 131575 63200083
Completed suicide 301.95 23.99 14 157350 145659 63185999
Asthenia 294.69 23.99 310 157054 383294 62948364
Lower respiratory tract infection 290.56 23.99 8 157356 132299 63199359
Drug interaction 289.77 23.99 103 157261 229028 63102630
Pain in extremity 286.12 23.99 241 157123 331245 63000413
Scar 285.90 23.99 252 157112 13530 63318128
Pruritus 281.10 23.99 289 157075 361164 62970494
Vaginal odour 279.14 23.99 87 157277 443 63331215
Febrile neutropenia 277.11 23.99 3 157361 118446 63213212
Thrombocytopenia 277.03 23.99 27 157337 151130 63180528
Abnormal uterine bleeding 276.65 23.99 114 157250 1432 63330226
Somnolence 275.74 23.99 54 157310 178631 63153027
Maternal exposure during pregnancy 274.74 23.99 101 157263 219961 63111697
White blood cell count decreased 273.98 23.99 18 157346 139086 63192572
Disease progression 260.39 23.99 10 157354 122748 63208910
Therapeutic product effect incomplete 256.02 23.99 13 157351 125043 63206615
Constipation 255.37 23.99 119 157245 224824 63106834
Device failure 253.98 23.99 168 157196 5843 63325815
Fear 249.49 23.99 248 157116 15518 63316140
Intra-abdominal haemorrhage 249.25 23.99 122 157242 2347 63329311
Weight decreased 249.07 23.99 193 157171 276605 63055053
Contusion 245.31 23.99 39 157325 150005 63181653
Erythema 243.62 23.99 67 157297 175684 63155974
Atrial fibrillation 242.38 23.99 11 157353 116625 63215033
Renal failure 241.58 23.99 12 157352 117640 63214018
Gait disturbance 240.85 23.99 77 157287 183101 63148557
Chlamydial infection 238.54 23.99 71 157293 300 63331358
Impaired healing 238.04 23.99 3 157361 102539 63229119
Hyponatraemia 237.73 23.99 9 157355 111891 63219767
Product use issue 237.73 23.99 125 157239 220395 63111263
Neuropathy peripheral 235.30 23.99 11 157353 113656 63218002
Meningioma 233.79 23.99 136 157228 3749 63327909
Injection site pain 233.13 23.99 25 157339 129775 63201883
Intentional product use issue 231.33 23.99 24 157340 127868 63203790
Pelvic discomfort 230.39 23.99 80 157284 601 63331057
Depressed mood 228.62 23.99 380 156984 39811 63291847
Blister 228.13 23.99 27 157337 129787 63201871
Intentional medical device removal by patient 226.78 23.99 55 157309 78 63331580
Anhedonia 226.31 23.99 200 157164 10774 63320884
Pancytopenia 224.29 23.99 3 157361 96930 63234728
Overdose 223.37 23.99 16 157348 115062 63216596
Adnexa uteri pain 221.81 23.99 70 157294 374 63331284
Polymenorrhoea 221.77 23.99 91 157273 1130 63330528
Bacterial vulvovaginitis 218.19 23.99 80 157284 716 63330942
Premenstrual syndrome 214.78 23.99 77 157287 642 63331016
Bronchitis 212.24 23.99 29 157335 124906 63206752
Platelet count decreased 212.07 23.99 21 157343 116101 63215557
Abortion of ectopic pregnancy 211.95 23.99 44 157320 9 63331649
Cardiac failure congestive 209.07 23.99 4 157360 92429 63239229
Uterine scar 208.95 23.99 46 157318 27 63331631
Hypokalaemia 208.70 23.99 12 157352 103792 63227866
Arthritis 206.47 23.99 23 157341 115898 63215760
Wheezing 202.00 23.99 8 157356 95587 63236071
Salpingitis 201.58 23.99 59 157305 232 63331426
Suppressed lactation 200.80 23.99 66 157298 410 63331248
Mood altered 199.12 23.99 213 157151 14530 63317128
Endometritis 199.06 23.99 80 157284 938 63330720
Presyncope 197.39 23.99 291 157073 27494 63304164
Mobility decreased 196.88 23.99 32 157332 121127 63210531
Respiratory failure 195.30 23.99 15 157349 101843 63229815
Osteoarthritis 194.85 23.99 10 157354 95333 63236325
Oxygen saturation decreased 192.11 23.99 6 157358 88579 63243079
Vaginal infection 192.05 23.99 155 157209 7363 63324295
Oedema peripheral 191.89 23.99 116 157248 189395 63142263
Progesterone receptor assay positive 191.78 23.99 60 157304 310 63331348
Chest pain 189.88 23.99 154 157210 215805 63115853
Pleural effusion 189.79 23.99 10 157354 93200 63238458
Malignant neoplasm progression 188.02 23.99 3 157361 82118 63249540
Blood pressure increased 186.56 23.99 84 157280 161978 63169680
Asthma 185.64 23.99 44 157320 127517 63204141
Smear cervix abnormal 184.91 23.99 106 157258 2840 63328818
Cardiac failure 183.28 23.99 9 157355 89133 63242525
Ill-defined disorder 183.06 23.99 4 157360 81751 63249907
Retained products of conception 181.85 23.99 46 157318 86 63331572
Blood creatinine increased 180.20 23.99 9 157355 87835 63243823
Psoriatic arthropathy 179.72 23.99 12 157352 91508 63240150
Haemoglobin decreased 179.43 23.99 68 157296 145417 63186241
Salpingectomy 178.16 23.99 52 157312 202 63331456
Pain 177.10 23.99 2693 154671 737935 62593723
Cardiac arrest 176.38 23.99 14 157350 92531 63239127
Sepsis 175.26 23.99 80 157284 153043 63178615
Blood cholesterol increased 174.36 23.99 16 157348 94016 63237642
Influenza 173.80 23.99 30 157334 108692 63222966
Endometriosis 171.62 23.99 126 157238 5194 63326464
Product use in unapproved indication 171.21 23.99 117 157247 178963 63152695
Hypertrichosis 169.61 23.99 74 157290 1080 63330578
Uterine cervical pain 169.03 23.99 36 157328 13 63331645
Loop electrosurgical excision procedure 168.06 23.99 38 157326 30 63331628
Device malfunction 167.59 23.99 214 157150 17643 63314015
Gastrointestinal disorder 167.51 23.99 58 157306 131181 63200477
Urinary tract infection 167.32 23.99 248 157116 264436 63067222
Renal impairment 166.63 23.99 14 157350 88341 63243317
Procedural dizziness 166.47 23.99 43 157321 91 63331567
Tubo-ovarian abscess 161.96 23.99 53 157311 324 63331334
Bacterial vaginosis 159.92 23.99 76 157288 1366 63330292
Actinomyces test positive 159.84 23.99 34 157330 12 63331646
Product shape issue 157.77 23.99 39 157325 63 63331595
Intentional overdose 157.36 23.99 6 157358 74146 63257512
Vulvovaginal pain 157.35 23.99 93 157271 2642 63329016
Ovarian cyst ruptured 157.31 23.99 71 157293 1128 63330530
Drug abuse 156.93 23.99 5 157359 72513 63259145
Herpes zoster 155.69 23.99 13 157351 82449 63249209
Device intolerance 152.34 23.99 37 157327 53 63331605
Irritability 152.02 23.99 278 157086 31416 63300242
Diffuse alopecia 151.97 23.99 64 157300 852 63330806
Uterine infection 150.33 23.99 50 157314 324 63331334
Haemorrhagic ovarian cyst 149.76 23.99 59 157305 654 63331004
COVID-19 149.58 23.99 47 157317 113056 63218602
Oedema 149.48 23.99 30 157334 97592 63234066
Blood glucose increased 148.17 23.99 17 157347 83739 63247919
Irritable bowel syndrome 147.63 23.99 16 157348 82396 63249262
Oropharyngeal pain 146.86 23.99 28 157336 94459 63237199
Psychological trauma 145.86 23.99 66 157298 1055 63330603
Coma 144.69 23.99 3 157361 64361 63267297
Pelvic adhesions 144.09 23.99 47 157317 284 63331374
Cellulitis 144.08 23.99 17 157347 81941 63249717
Muscular weakness 143.03 23.99 62 157302 122291 63209367
Injection site erythema 141.97 23.99 19 157345 83155 63248503
Breast cancer 141.77 23.99 347 157017 48036 63283622
Folliculitis 141.73 23.99 8 157356 70309 63261349
Pelvic fluid collection 141.32 23.99 60 157304 816 63330842
C-reactive protein increased 141.11 23.99 31 157333 94676 63236982
Hydrometra 140.84 23.99 33 157331 36 63331622
Leukopenia 138.46 23.99 15 157349 77275 63254383
Therapy non-responder 137.85 23.99 14 157350 75887 63255771
Patient-device incompatibility 137.34 23.99 39 157325 134 63331524
Hospitalisation 137.03 23.99 23 157341 85058 63246600
Inappropriate schedule of product administration 136.06 23.99 44 157320 103921 63227737
Oestrogen receptor assay positive 134.97 23.99 50 157314 462 63331196
Interstitial lung disease 134.93 23.99 4 157360 61904 63269754
Dry mouth 134.79 23.99 17 157347 77846 63253812
Pelvic infection 130.29 23.99 45 157319 332 63331326
Migraine 129.79 23.99 554 156810 102792 63228866
Depressed level of consciousness 128.47 23.99 6 157358 62072 63269586
Dysphagia 127.99 23.99 31 157333 88554 63243104
Hypoxia 126.32 23.99 5 157359 59787 63271871
Medical device site discomfort 125.52 23.99 41 157323 249 63331409
Productive cough 124.94 23.99 8 157356 63200 63268458
Liver injury 124.76 23.99 6 157358 60514 63271144
Upper respiratory tract infection 123.98 23.99 26 157338 82021 63249637
Cardio-respiratory arrest 123.42 23.99 6 157358 59953 63271705
Hirsutism 123.33 23.99 63 157301 1332 63330326
Epistaxis 123.20 23.99 17 157347 72708 63258950
Vulvovaginal discomfort 121.67 23.99 75 157289 2303 63329355
Gynaecological chlamydia infection 120.23 23.99 26 157338 12 63331646
Panic attack 120.15 23.99 206 157158 22125 63309533
Procedural nausea 119.87 23.99 53 157311 800 63330858
Lung disorder 119.81 23.99 9 157355 62252 63269406
Pregnancy after post coital contraception 119.70 23.99 25 157339 6 63331652
Alanine aminotransferase increased 119.05 23.99 54 157310 103716 63227942
Osteoporosis 117.19 23.99 6 157358 57332 63274326
Hormone level abnormal 116.20 23.99 74 157290 2409 63329249
Uterine polyp 116.09 23.99 69 157295 1981 63329677
Neutrophil count decreased 114.97 23.99 6 157358 56400 63275258
Fibromyalgia 114.52 23.99 29 157335 80391 63251267
Gastrooesophageal reflux disease 114.11 23.99 47 157317 95592 63236066
Pregnancy with implant contraceptive 113.38 23.99 75 157289 2608 63329050
Type 2 diabetes mellitus 112.88 23.99 13 157351 63855 63267803
Haematosalpinx 112.25 23.99 23 157341 3 63331655
Aspartate aminotransferase increased 111.60 23.99 42 157322 90235 63241423
Myocardial infarction 111.48 23.99 54 157310 99839 63231819
Heart rate increased 111.33 23.99 47 157317 94191 63237467
Medical device entrapment 110.06 23.99 22 157342 0 63331658
Therapeutic response decreased 110.05 23.99 12 157352 61513 63270145
Nasal congestion 109.70 23.99 16 157348 65644 63266014
Rhinorrhoea 109.51 23.99 16 157348 65561 63266097
Bradycardia 109.02 23.99 24 157340 73203 63258455
Dyspepsia 108.46 23.99 59 157305 102137 63229521
Cataract 107.68 23.99 9 157355 57044 63274614
Uterine adhesions 107.31 23.99 25 157339 26 63331632
Hepatic adenoma 107.25 23.99 38 157326 305 63331353
Peritoneal adhesions 107.23 23.99 35 157329 212 63331446
Multiple organ dysfunction syndrome 106.98 23.99 9 157355 56743 63274915
Hyperkalaemia 106.72 23.99 7 157357 54196 63277462
Hypoglycaemia 106.72 23.99 12 157352 60053 63271605
Inflammation 105.58 23.99 36 157328 82237 63249421
Chest discomfort 104.85 23.99 72 157292 109897 63221761
Tremor 103.40 23.99 105 157259 132134 63199524
Abortion missed 102.97 23.99 60 157304 1659 63329999
Mucosal inflammation 102.38 23.99 3 157361 46925 63284733
Insomnia 102.07 23.99 240 157124 215012 63116646
Loss of personal independence in daily activities 100.60 23.99 58 157306 97232 63234426
Abdominal distension 100.13 23.99 453 156911 86162 63245496
Hallucination 99.83 23.99 10 157354 54807 63276851
Uterine injury 98.97 23.99 24 157340 34 63331624
Focal nodular hyperplasia 98.44 23.99 41 157323 530 63331128
Dizziness 98.37 23.99 643 156721 429282 62902376
Metabolic acidosis 97.89 23.99 3 157361 45066 63286592
Diabetes mellitus 97.05 23.99 12 157352 55798 63275860
Procedural vomiting 97.02 23.99 40 157324 503 63331155
Blood pressure systolic increased 96.73 23.99 5 157359 47392 63284266
Cervicitis 96.16 23.99 39 157325 469 63331189
Cervical polyp 96.12 23.99 32 157332 208 63331450
Chloasma 95.88 23.99 22 157342 20 63331638
Papilloedema 95.59 23.99 79 157285 3881 63327777
Dyspnoea exertional 95.57 23.99 17 157347 60285 63271373
Patient dissatisfaction with device 95.05 23.99 19 157345 0 63331658
Cervix injury 95.05 23.99 19 157345 0 63331658
Procedural complication 94.37 23.99 90 157274 5349 63326309
Uterine enlargement 94.27 23.99 51 157313 1217 63330441
Intentional product misuse 92.66 23.99 19 157345 60898 63270760
Pulmonary oedema 92.54 23.99 13 157351 54860 63276798
Device ineffective 90.43 23.99 31 157333 223 63331435
Musculoskeletal pain 89.87 23.99 59 157305 92218 63239440
Chronic kidney disease 88.97 23.99 6 157358 45392 63286266
Chlamydia test positive 87.79 23.99 20 157344 17 63331641
Injection site reaction 87.49 23.99 19 157345 58505 63273153
Intentional device use issue 87.40 23.99 23 157341 54 63331604
Genital discharge 87.40 23.99 23 157341 54 63331604
Endometrial hyperplasia 87.38 23.99 43 157321 837 63330821
Psoriasis 86.87 23.99 54 157310 86903 63244755
Genital pain 86.66 23.99 35 157329 416 63331242
Cervix disorder 86.22 23.99 38 157326 569 63331089
Salpingo-oophoritis 86.04 23.99 26 157338 117 63331541
Endometrial thickening 85.99 23.99 33 157331 339 63331319
Rhabdomyolysis 85.58 23.99 6 157358 43945 63287713
Chills 85.29 23.99 93 157271 113285 63218373
Gonorrhoea 84.88 23.99 25 157339 101 63331557
Hyperglycaemia 83.64 23.99 5 157359 41862 63289796
Actinomycosis 83.03 23.99 44 157320 1006 63330652
Uterine inflammation 81.93 23.99 19 157345 19 63331639
Gastrointestinal injury 81.86 23.99 36 157328 536 63331122
Uterine cervical laceration 81.46 23.99 17 157347 4 63331654
Joint stiffness 80.70 23.99 6 157358 41863 63289795
Skin ulcer 80.66 23.99 7 157357 43038 63288620
Procedural anxiety 80.30 23.99 39 157325 737 63330921
Colposcopy 80.29 23.99 18 157346 13 63331645
Red blood cell sedimentation rate increased 80.15 23.99 8 157356 43974 63287684
Incorrect dose administered 79.12 23.99 25 157339 59943 63271715
Septic shock 79.06 23.99 33 157331 66596 63265062
Encephalopathy 79.05 23.99 4 157360 38616 63293042
Wrong technique in product usage process 78.74 23.99 28 157336 62312 63269346
Flushing 78.72 23.99 44 157320 75043 63256615
Bursitis 78.57 23.99 3 157361 37038 63294620
Red blood cell count decreased 77.85 23.99 6 157358 40639 63291019
Injection site pruritus 77.71 23.99 10 157354 45106 63286552
Pregnancy test positive 77.69 23.99 24 157340 118 63331540
Adenomyosis 77.45 23.99 34 157330 504 63331154
Bone pain 77.22 23.99 20 157344 54621 63277037
Cardiac disorder 76.98 23.99 16 157348 50800 63280858
Agitation 76.92 23.99 26 157338 59731 63271927
Sedation 76.43 23.99 5 157359 38804 63292854
Injection site swelling 76.28 23.99 13 157351 47559 63284099
Uterine tenderness 75.99 23.99 17 157347 12 63331646
Anembryonic gestation 75.85 23.99 34 157330 531 63331127
Memory impairment 75.71 23.99 88 157276 104170 63227488
Injection site bruising 75.40 23.99 8 157356 41902 63289756
Post abortion haemorrhage 75.37 23.99 21 157343 66 63331592
Hepatic failure 75.25 23.99 3 157361 35653 63296005
Product contamination 75.06 23.99 37 157327 723 63330935
Abdominal pain upper 74.51 23.99 262 157102 206182 63125476
Dysphonia 74.21 23.99 14 157350 47600 63284058
Colitis 74.09 23.99 15 157349 48513 63283145
Pain in jaw 74.06 23.99 10 157354 43486 63288172
Myalgia 73.81 23.99 158 157206 146371 63185287
Diverticulitis 72.60 23.99 7 157357 39550 63292108
Acute respiratory failure 72.45 23.99 3 157361 34482 63297176
Adverse drug reaction 72.31 23.99 55 157309 79659 63251999
Respiratory tract infection 71.93 23.99 9 157355 41474 63290184
Benign hydatidiform mole 71.92 23.99 22 157342 104 63331554
Drug-induced liver injury 71.54 23.99 8 157356 40214 63291444
Liver disorder 71.51 23.99 22 157342 53665 63277993
Blood pressure fluctuation 71.38 23.99 14 157350 46303 63285355
Headache 71.23 23.99 1123 156241 632118 62699540
Respiratory distress 71.17 23.99 3 157361 33948 63297710
Pneumonitis 70.99 23.99 4 157360 35218 63296440
Balance disorder 70.69 23.99 63 157301 84359 63247299
Cognitive disorder 70.61 23.99 25 157339 55790 63275868
Human chorionic gonadotropin decreased 70.36 23.99 18 157346 36 63331622
Influenza like illness 70.28 23.99 39 157325 66785 63264873
Mental status changes 70.12 23.99 8 157356 39591 63292067
Penile pain 70.04 23.99 14 157350 0 63331658
Chemical poisoning 69.87 23.99 19 157345 53 63331605
Hepatotoxicity 69.47 23.99 6 157358 37035 63294623
Illness 69.25 23.99 18 157346 49041 63282617
Respiratory disorder 68.94 23.99 8 157356 39074 63292584
Multiple sclerosis relapse 68.02 23.99 18 157346 48460 63283198
Heart rate decreased 67.68 23.99 15 157349 45545 63286113
Orthostatic hypotension 67.43 23.99 6 157358 36154 63295504
Cervical conisation 67.33 23.99 14 157350 3 63331655
Hepatic function abnormal 67.05 23.99 7 157357 37135 63294523
Breast swelling 66.04 23.99 42 157322 1364 63330294
Lethargy 66.03 23.99 28 157336 55979 63275679
Haematochezia 66.02 23.99 25 157339 53519 63278139
Mouth ulceration 65.70 23.99 4 157360 32980 63298678
Rectal haemorrhage 65.47 23.99 20 157344 49010 63282648
Endometrial cancer 64.95 23.99 58 157306 3167 63328491
Lactic acidosis 64.72 23.99 9 157355 38278 63293380
Cerebrovascular accident 64.54 23.99 105 157259 107919 63223739
Pulmonary hypertension 64.50 23.99 8 157356 37115 63294543
Joint range of motion decreased 64.39 23.99 4 157360 32424 63299234
Blood potassium decreased 64.14 23.99 13 157351 42013 63289645
Acne cystic 62.85 23.99 29 157335 486 63331172
Full blood count abnormal 62.72 23.99 4 157360 31713 63299945
Hypocalcaemia 62.71 23.99 4 157360 31709 63299949
Vulvovaginal pruritus 62.70 23.99 57 157307 3186 63328472
Exposure during pregnancy 62.64 23.99 188 157176 155359 63176299
Localised infection 62.24 23.99 3 157361 30207 63301451
Uterine contractions abnormal 61.94 23.99 23 157341 214 63331444
Pericardial effusion 61.88 23.99 3 157361 30055 63301603
Therapy interrupted 61.57 23.99 5 157359 32450 63299208
No adverse event 61.55 23.99 234 157130 41171 63290487
Coronary artery disease 61.39 23.99 5 157359 32372 63299286
Hepatitis 61.37 23.99 12 157352 39776 63291882
Rash maculo-papular 60.27 23.99 5 157359 31891 63299767
Gastritis 60.24 23.99 10 157354 37293 63294365
Renal disorder 60.08 23.99 6 157358 32968 63298690
Habitual abortion 60.03 23.99 12 157352 0 63331658
Rash pruritic 59.91 23.99 37 157327 59762 63271896
Oligomenorrhoea 59.87 23.99 33 157331 818 63330840
Therapy cessation 59.76 23.99 4 157360 30453 63301205
Endometrial atrophy 59.73 23.99 17 157347 59 63331599
Unresponsive to stimuli 59.46 23.99 7 157357 33809 63297849
Medical device site pain 59.11 23.99 21 157343 170 63331488
Weight increased 59.05 23.99 941 156423 259851 63071807
Migraine with aura 58.62 23.99 51 157313 2689 63328969
Gait inability 58.51 23.99 29 157335 52930 63278728
Seborrhoea 58.33 23.99 27 157337 456 63331202
Cervix haemorrhage uterine 58.08 23.99 14 157350 19 63331639
Breast discharge 57.17 23.99 34 157330 977 63330681
Pancreatitis 57.07 23.99 25 157339 49030 63282628
Anaphylactic reaction 56.95 23.99 48 157316 66052 63265606
Skin exfoliation 56.80 23.99 18 157346 43084 63288574
Blood pressure decreased 56.29 23.99 47 157317 64975 63266683
Hypophagia 56.15 23.99 6 157358 31253 63300405
Treatment noncompliance 56.03 23.99 12 157352 37313 63294345
Ear infection 55.92 23.99 13 157351 38200 63293458
Sciatica 55.88 23.99 9 157355 34315 63297343
Clostridium difficile infection 55.70 23.99 5 157359 29917 63301741
Drug eruption 55.62 23.99 4 157360 28690 63302968
Genito-pelvic pain/penetration disorder 55.18 23.99 12 157352 6 63331652
Fallopian tube perforation 55.03 23.99 11 157353 0 63331658
Hypercalcaemia 54.75 23.99 4 157360 28318 63303340
Throat irritation 54.71 23.99 13 157351 37634 63294024
Liver function test abnormal 53.81 23.99 26 157338 48155 63283503
White blood cell count increased 53.04 23.99 27 157337 48534 63283124
Underdose 52.73 23.99 4 157360 27452 63304206
Incorrect route of product administration 52.72 23.99 4 157360 27448 63304210
Prescribed underdose 52.56 23.99 6 157358 29683 63301975
Endometrial hypertrophy 52.10 23.99 22 157342 295 63331363
Abdominal adhesions 52.09 23.99 51 157313 3131 63328527
Progesterone decreased 52.08 23.99 17 157347 103 63331555
Adnexa uteri cyst 51.66 23.99 17 157347 106 63331552
Uterine stenosis 51.63 23.99 11 157353 4 63331654
Ear pain 51.46 23.99 13 157351 36105 63295553
Blood alkaline phosphatase increased 51.43 23.99 21 157343 42946 63288712
Pregnancy on oral contraceptive 51.27 23.99 32 157332 1005 63330653
Intracranial pressure increased 51.19 23.99 64 157300 5163 63326495
Altered state of consciousness 50.44 23.99 3 157361 25227 63306431
Retained placenta or membranes 50.30 23.99 22 157342 323 63331335
Ectopic pregnancy under hormonal contraception 50.03 23.99 10 157354 0 63331658
Biopsy endometrium 50.03 23.99 10 157354 0 63331658
Cervical discharge 50.03 23.99 10 157354 0 63331658
Ulcer 49.59 23.99 4 157360 26103 63305555
Vulvovaginal mycotic infection 49.56 23.99 65 157299 5501 63326157
Cervical cyst 49.27 23.99 17 157347 125 63331533
Tooth disorder 49.08 23.99 6 157358 28151 63303507
Live birth 48.48 23.99 4 157360 25626 63306032
Macular degeneration 48.42 23.99 3 157361 24373 63307285
Infection 48.21 23.99 351 157013 228822 63102836
Dysgeusia 48.06 23.99 28 157336 46682 63284976
Swelling face 47.80 23.99 52 157312 63423 63268235
Disorientation 47.68 23.99 19 157345 39433 63292225
Cervix inflammation 47.41 23.99 10 157354 3 63331655
Haematemesis 47.27 23.99 9 157355 30403 63301255
Abortion spontaneous incomplete 47.24 23.99 12 157352 23 63331635
Uterine haematoma 47.24 23.99 12 157352 23 63331635
Oral pain 47.23 23.99 7 157357 28387 63303271
Road traffic accident 47.04 23.99 16 157348 36616 63295042
Drug withdrawal syndrome 46.90 23.99 6 157358 27188 63304470
Negative thoughts 46.83 23.99 29 157335 898 63330760
Viral infection 46.81 23.99 15 157349 35648 63296010
Cyst 46.58 23.99 106 157258 13993 63317665
Hepatic cirrhosis 46.40 23.99 4 157360 24730 63306928
Complication of pregnancy 46.27 23.99 25 157339 595 63331063
General physical health deterioration 46.05 23.99 301 157063 201101 63130557
Tachycardia 46.00 23.99 145 157219 118011 63213647
Cerebral haemorrhage 45.88 23.99 10 157354 30719 63300939
Expired product administered 45.72 23.99 66 157298 6115 63325543
Joint injury 45.44 23.99 9 157355 29563 63302095
Ovarian germ cell teratoma benign 45.39 23.99 15 157349 95 63331563
Blood sodium decreased 45.28 23.99 4 157360 24248 63307410
Blood creatine phosphokinase increased 45.23 23.99 10 157354 30420 63301238
Lower limb fracture 45.21 23.99 4 157360 24217 63307441
Breast discomfort 45.21 23.99 23 157341 482 63331176
Toxic epidermal necrolysis 45.15 23.99 5 157359 25329 63306329
Haematoma 45.07 23.99 15 157349 34805 63296853
Chlamydial pelvic inflammatory disease 45.02 23.99 9 157355 0 63331658
Biopsy cervix 45.02 23.99 9 157355 0 63331658
Uterine fibrosis 45.02 23.99 9 157355 0 63331658
Staphylococcal infection 44.96 23.99 23 157341 41233 63290425
Gastric ulcer 44.78 23.99 4 157360 24033 63307625
Vulvovaginal dryness 44.72 23.99 45 157319 2856 63328802
Oral candidiasis 44.71 23.99 3 157361 22795 63308863
Agranulocytosis 44.70 23.99 5 157359 25129 63306529
Liver function test increased 44.51 23.99 13 157351 32798 63298860
Pelvic haemorrhage 44.46 23.99 16 157348 135 63331523
Oral herpes 44.38 23.99 6 157358 26068 63305590
Fallopian tube disorder 44.35 23.99 22 157342 436 63331222
Haematocrit decreased 44.28 23.99 21 157343 39319 63292339
Leukocytosis 44.06 23.99 6 157358 25929 63305729
Fear of disease 43.95 23.99 32 157332 1302 63330356
Pelvic organ injury 43.63 23.99 10 157354 9 63331649
Acute abdomen 43.54 23.99 34 157330 1539 63330119
Osteonecrosis 43.32 23.99 5 157359 24525 63307133
Limb injury 43.04 23.99 6 157358 25471 63306187
Rash erythematous 43.00 23.99 26 157338 42484 63289174
Cervix carcinoma stage 0 42.93 23.99 20 157344 343 63331315
Hepatocellular injury 42.77 23.99 8 157356 27373 63304285
Blood lactate dehydrogenase increased 42.66 23.99 4 157360 23112 63308546
Cystitis 42.58 23.99 44 157320 54947 63276711
Dry skin 42.39 23.99 47 157317 56840 63274818
Seizure 42.23 23.99 177 157187 132457 63199201
Skin lesion 41.99 23.99 12 157352 30709 63300949
Hypoaesthesia 41.95 23.99 245 157119 168148 63163510
Eosinophilia 41.83 23.99 4 157360 22752 63308906
Skin laceration 41.72 23.99 4 157360 22704 63308954
Sexually transmitted disease 41.58 23.99 17 157347 209 63331449
Pulmonary mass 41.46 23.99 4 157360 22592 63309066
Device allergy 41.45 23.99 12 157352 45 63331613
Acute myocardial infarction 41.30 23.99 14 157350 32110 63299548
Acute respiratory distress syndrome 41.06 23.99 5 157359 23529 63308129
Suicide attempt 40.48 23.99 55 157309 60863 63270795
Cytomegalovirus infection 40.39 23.99 3 157361 20949 63310709
Haemangioma of liver 40.35 23.99 29 157335 1156 63330502
Blood bilirubin increased 40.04 23.99 21 157343 37119 63294539
Chlamydial cervicitis 40.02 23.99 8 157356 0 63331658
Basal cell carcinoma 40.02 23.99 10 157354 27981 63303677
Frequent bowel movements 39.90 23.99 5 157359 23017 63308641
Hepatic steatosis 39.76 23.99 11 157353 28758 63302900
Transaminases increased 39.76 23.99 14 157350 31353 63300305
Ovarian vein thrombosis 39.53 23.99 12 157352 55 63331603
Abnormal withdrawal bleeding 39.36 23.99 12 157352 56 63331602
Papilloma viral infection 39.32 23.99 32 157332 1538 63330120
Bladder perforation 39.18 23.99 15 157349 153 63331505
Gastric disorder 39.01 23.99 22 157342 37347 63294311
Gastroenteritis 39.00 23.99 9 157355 26581 63305077
Rib fracture 38.94 23.99 5 157359 22592 63309066
Atelectasis 38.90 23.99 4 157360 21479 63310179
Affective disorder 38.87 23.99 61 157303 6085 63325573
Adnexal torsion 38.68 23.99 20 157344 434 63331224
Fluid retention 38.55 23.99 55 157309 59631 63272027
Infertility 38.36 23.99 24 157340 757 63330901
Genital infection bacterial 37.48 23.99 8 157356 3 63331655
Sleep apnoea syndrome 36.93 23.99 13 157351 29120 63302538
Urticaria 36.78 23.99 250 157114 165552 63166106
Neoplasm malignant 36.71 23.99 14 157350 29847 63301811
Pulmonary arterial hypertension 36.57 23.99 6 157358 22571 63309087
Breast cancer in situ 36.22 23.99 30 157334 1478 63330180
Loss of consciousness 36.15 23.99 160 157204 117961 63213697
Dyskinesia 36.15 23.99 17 157347 31985 63299673
Sinus tachycardia 36.02 23.99 8 157356 24260 63307398
Lymphocyte count decreased 35.87 23.99 15 157349 30242 63301416
Toxic shock syndrome streptococcal 35.69 23.99 13 157351 114 63331544
Stevens-Johnson syndrome 35.50 23.99 9 157355 24941 63306717
Ventricular tachycardia 35.46 23.99 4 157360 19975 63311683
Nodule 35.40 23.99 5 157359 21021 63310637
Fallopian tube cyst 35.29 23.99 13 157351 118 63331540
Obesity 35.26 23.99 15 157349 29937 63301721
Subchorionic haemorrhage 35.23 23.99 14 157350 159 63331499
Depression suicidal 35.16 23.99 32 157332 1791 63329867
Head injury 35.12 23.99 12 157352 27384 63304274
Pelvic abscess 35.11 23.99 31 157333 1667 63329991
Persistent urogenital sinus 35.02 23.99 7 157357 0 63331658
Conjunctivitis 34.89 23.99 5 157359 20791 63310867
Intervertebral disc protrusion 34.82 23.99 8 157356 23701 63307957
Dry eye 34.62 23.99 30 157334 40731 63290927
Cholestasis 34.24 23.99 15 157349 29419 63302239
Blood potassium increased 34.24 23.99 3 157361 18306 63313352
Spinal fracture 34.15 23.99 3 157361 18268 63313390
Uterine cyst 34.11 23.99 18 157346 408 63331250
Hydrosalpinx 34.01 23.99 8 157356 9 63331649
Alopecia 33.76 23.99 611 156753 336925 62994733
Drug ineffective 33.61 23.99 3014 154350 1041751 62289907
Intentional self-injury 33.36 23.99 11 157353 25676 63305982
Electrolyte imbalance 33.28 23.99 5 157359 20071 63311587
Dysarthria 33.26 23.99 34 157330 42677 63288981
Breast cyst 33.25 23.99 31 157333 1790 63329868
Exostosis 33.20 23.99 3 157361 17859 63313799
Paraesthesia 33.19 23.99 240 157124 156726 63174932
Haemorrhagic cyst 33.13 23.99 14 157350 188 63331470
Vertigo 33.10 23.99 258 157106 59629 63272029
Disease recurrence 33.06 23.99 14 157350 28016 63303642
Blood glucose decreased 32.99 23.99 6 157358 20946 63310712
Pancreatitis acute 32.96 23.99 13 157351 27153 63304505
Device deposit issue 32.86 23.99 9 157355 26 63331632
Joint dislocation 32.78 23.99 4 157360 18796 63312862
Metastases to liver 32.74 23.99 9 157355 23630 63308028
Blood pressure diastolic decreased 32.68 23.99 8 157356 22698 63308960
Drug dependence 32.66 23.99 10 157354 24473 63307185
Gilbert's syndrome 32.53 23.99 7 157357 3 63331655
Laboratory test abnormal 32.45 23.99 13 157351 26899 63304759
Movement disorder 32.44 23.99 7 157357 21654 63310004
Post abortion complication 32.33 23.99 8 157356 13 63331645
Haematuria 32.15 23.99 16 157348 29141 63302517
Wound infection 31.89 23.99 7 157357 21403 63310255
Bronchospasm 31.86 23.99 3 157361 17277 63314381
Acute hepatic failure 31.71 23.99 4 157360 18323 63313335
Placenta accreta 31.62 23.99 14 157350 212 63331446
Urinary retention 31.40 23.99 18 157346 30283 63301375
Toothache 31.33 23.99 5 157359 19194 63312464
Perineal pain 31.20 23.99 15 157349 277 63331381
Metastases to bone 31.05 23.99 7 157357 21012 63310646
Gastroenteritis viral 31.05 23.99 10 157354 23690 63307968
Hypothyroidism 30.92 23.99 36 157328 42596 63289062
Infusion site pain 30.91 23.99 3 157361 16866 63314792
Premature menopause 30.89 23.99 22 157342 864 63330794
Adrenal insufficiency 30.78 23.99 4 157360 17911 63313747
Glaucoma 30.68 23.99 5 157359 18900 63312758
Respiratory tract congestion 30.59 23.99 4 157360 17828 63313830
Genital infection female 30.55 23.99 11 157353 93 63331565
Uterine mass 30.48 23.99 15 157349 292 63331366
Injection site rash 30.46 23.99 5 157359 18804 63312854
Procedural headache 30.22 23.99 12 157352 136 63331522
Neutrophil count increased 30.13 23.99 3 157361 16524 63315134
Labelled drug-disease interaction medication error 30.06 23.99 12 157352 138 63331520
Fallopian tube obstruction 30.02 23.99 6 157358 0 63331658
Inadequate lubrication 30.02 23.99 6 157358 0 63331658
Otosclerosis 30.02 23.99 6 157358 0 63331658
Fear of pregnancy 30.02 23.99 6 157358 0 63331658
Eye pain 29.88 23.99 24 157340 33830 63297828
Haemoptysis 29.86 23.99 17 157347 28709 63302949
Vulvovaginal swelling 29.78 23.99 18 157346 533 63331125
Ectropion of cervix 29.78 23.99 10 157354 67 63331591
Pulmonary congestion 29.66 23.99 4 157360 17414 63314244
Burning sensation 29.66 23.99 56 157308 54351 63277307
Endometrial disorder 29.64 23.99 20 157344 719 63330939
Angina pectoris 29.59 23.99 19 157345 30059 63301599
Lymphopenia 29.40 23.99 5 157359 18322 63313336
Abnormal weight gain 29.34 23.99 29 157335 1801 63329857
Female genital operation 29.24 23.99 8 157356 23 63331635
Emotional disorder 29.13 23.99 86 157278 13293 63318365
Pregnancy 28.89 23.99 173 157191 36663 63294995
Menopausal symptoms 28.81 23.99 33 157331 2428 63329230
Laryngitis 28.65 23.99 4 157360 16963 63314695
Cyanosis 28.58 23.99 4 157360 16931 63314727
Skin discolouration 28.46 23.99 31 157333 37797 63293861
Osteopenia 28.42 23.99 7 157357 19778 63311880
Product administration error 28.38 23.99 10 157354 22387 63309271
Musculoskeletal disorder 28.33 23.99 8 157356 20636 63311022
Product prescribing error 28.14 23.99 15 157349 26274 63305384
Blood test abnormal 28.07 23.99 3 157361 15626 63316032
Mitral valve incompetence 28.01 23.99 7 157357 19587 63312071
Sinus disorder 27.80 23.99 13 157351 24540 63307118
Peripheral venous disease 27.72 23.99 3 157361 15474 63316184
Eye irritation 27.52 23.99 10 157354 21961 63309697
Ocular hyperaemia 27.42 23.99 14 157350 25130 63306528
Body temperature increased 27.41 23.99 31 157333 37161 63294497
Hallucination, visual 27.39 23.99 7 157357 19291 63312367
Small intestinal obstruction 27.31 23.99 6 157358 18331 63313327
Bacteraemia 27.25 23.99 5 157359 17343 63314315
Invasive ductal breast carcinoma 27.21 23.99 56 157308 6902 63324756
Uterine dilation and curettage 27.17 23.99 21 157343 936 63330722
Swollen tongue 26.76 23.99 28 157336 34772 63296886
Uterine disorder 26.66 23.99 36 157328 3133 63328525
Ovarian rupture 26.65 23.99 8 157356 35 63331623
Oesophagitis 26.65 23.99 3 157361 15005 63316653
Skin infection 26.64 23.99 3 157361 14999 63316659
Adnexa uteri mass 26.62 23.99 17 157347 556 63331102
Joint effusion 26.61 23.99 5 157359 17055 63314603
Human papilloma virus test positive 26.57 23.99 17 157347 558 63331100
Lacrimation increased 26.51 23.99 9 157355 20622 63311036
Retinal vein thrombosis 26.47 23.99 16 157348 474 63331184
Feeling hot 26.43 23.99 53 157311 50301 63281357
Ovarian abscess 26.29 23.99 12 157352 196 63331462
Ankle fracture 26.27 23.99 6 157358 17849 63313809
Injection site mass 26.03 23.99 7 157357 18649 63313009
Genital discomfort 25.99 23.99 9 157355 67 63331591
Platelet count increased 25.96 23.99 6 157358 17705 63313953
Intervertebral disc degeneration 25.89 23.99 4 157360 15728 63315930
Induced abortion haemorrhage 25.87 23.99 6 157358 6 63331652
Polyneuropathy 25.70 23.99 3 157361 14586 63317072
Retroplacental haematoma 25.69 23.99 11 157353 153 63331505
Neck pain 25.63 23.99 87 157277 69231 63262427
Hysteroscopy 25.62 23.99 8 157356 41 63331617
Female sexual dysfunction 25.62 23.99 8 157356 41 63331617
Hypoacusis 25.53 23.99 14 157350 24137 63307521
Pharyngitis 25.51 23.99 9 157355 20134 63311524
Abortion induced 25.39 23.99 69 157295 10173 63321485
Candida infection 25.15 23.99 20 157344 28331 63303327
Polycystic ovaries 25.04 23.99 42 157322 4429 63327229
Cervix erythema 25.01 23.99 5 157359 0 63331658
Cervical friability 25.01 23.99 5 157359 0 63331658
Myometritis 25.01 23.99 5 157359 0 63331658
Genital injury 25.01 23.99 5 157359 0 63331658
Ectopic pregnancy termination 24.95 23.99 6 157358 8 63331650
Weight loss poor 24.89 23.99 22 157342 1185 63330473
Angioedema 24.74 23.99 51 157313 47914 63283744
Polymenorrhagia 24.71 23.99 8 157356 47 63331611
Spinal osteoarthritis 24.71 23.99 5 157359 16181 63315477
Galactorrhoea 24.58 23.99 40 157324 4115 63327543
Diabetes mellitus inadequate control 24.54 23.99 4 157360 15122 63316536
Endometrial adenocarcinoma 24.44 23.99 22 157342 1214 63330444
Lactation disorder 24.39 23.99 14 157350 376 63331282
Lymphadenopathy 24.28 23.99 36 157328 38422 63293236
Jaundice 24.27 23.99 22 157342 29229 63302429
Hemianaesthesia 24.22 23.99 14 157350 381 63331277
Eye disorder 24.20 23.99 13 157351 22672 63308986
Cholelithiasis 24.13 23.99 45 157319 43880 63287778
Libido disorder 24.03 23.99 8 157356 52 63331606

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
Penile pain 3082.64 714.68 342 186 1221 34955182

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
Device expulsion 95440.64 29.63 18307 104224 7554 79614303
Device dislocation 29197.68 29.63 6959 115572 19011 79602846
Genital haemorrhage 16657.42 29.63 3408 119123 2847 79619010
Uterine perforation 14334.57 29.63 3014 119517 3289 79618568
Pregnancy with contraceptive device 11135.13 29.63 2229 120302 1425 79620432
Complication of device insertion 9787.60 29.63 2207 120324 4143 79617714
Procedural pain 9556.38 29.63 2813 119718 20271 79601586
Abdominal pain lower 8131.06 29.63 2680 119851 29102 79592755
Embedded device 6586.78 29.63 1420 121111 1899 79619958
Pelvic pain 6140.16 29.63 1768 120763 11613 79610244
Vaginal haemorrhage 5428.28 29.63 1803 120728 20014 79601843
Device difficult to use 5028.46 29.63 1515 121016 11870 79609987
Ectopic pregnancy with contraceptive device 4541.10 29.63 864 121667 221 79621636
Complication of device removal 3925.77 29.63 960 121571 2929 79618928
Device breakage 3857.45 29.63 1173 121358 9502 79612355
Heavy menstrual bleeding 3660.11 29.63 1202 121329 12809 79609048
Device issue 3510.18 29.63 1383 121148 25725 79596132
Device use issue 3475.78 29.63 816 121715 1968 79619889
Medical device discomfort 3453.93 29.63 746 121785 1008 79620849
Complication associated with device 3235.38 29.63 1159 121372 16337 79605520
Post procedural discomfort 3234.61 29.63 646 121885 394 79621463
Injury 3180.91 29.63 1786 120745 75710 79546147
Amenorrhoea 2756.12 29.63 840 121691 6852 79615005
Medical device pain 2729.81 29.63 593 121938 838 79621019
Uterine rupture 2564.34 29.63 501 122030 220 79621637
Dyspareunia 2272.36 29.63 540 121991 1398 79620459
Emotional distress 2142.69 29.63 1101 121430 38868 79582989
Device deployment issue 1483.23 29.63 427 122104 2785 79619072
Post procedural haemorrhage 1440.62 29.63 603 121928 13141 79608716
Uterine spasm 1393.60 29.63 287 122244 250 79621607
Unintentional medical device removal 1380.23 29.63 499 122032 7213 79614644
Ovarian cyst 1328.99 29.63 556 121975 12099 79609758
Abdominal pain 1328.38 29.63 2242 120289 387327 79234530
Haemorrhage in pregnancy 1260.19 29.63 316 122215 1098 79620759
Loss of libido 1257.92 29.63 361 122170 2324 79619533
Intermenstrual bleeding 1198.05 29.63 419 122112 5465 79616392
Ruptured ectopic pregnancy 1151.61 29.63 236 122295 195 79621662
Expired device used 1109.64 29.63 227 122304 184 79621673
Dysmenorrhoea 1016.08 29.63 315 122216 2730 79619127
Procedural haemorrhage 1000.05 29.63 346 122185 4360 79617497
Depression 971.05 29.63 1416 121115 215374 79406483
Intentional device misuse 963.32 29.63 227 122304 558 79621299
Menstruation irregular 946.77 29.63 338 122193 4698 79617159
Off label use of device 945.93 29.63 197 122334 192 79621665
Vaginal discharge 920.43 29.63 368 122163 7095 79614762
Uterine cervix stenosis 915.18 29.63 175 122356 50 79621807
Anxiety 899.61 29.63 1471 121060 247041 79374816
Diarrhoea 885.62 29.63 147 122384 880342 78741515
Pneumonia 855.60 29.63 38 122493 660208 78961649
Uterine haemorrhage 838.49 29.63 269 122262 2634 79619223
Device physical property issue 822.83 29.63 259 122272 2371 79619486
Coital bleeding 791.00 29.63 167 122364 185 79621672
Death 777.98 29.63 20 122511 566494 79055363
Pelvic inflammatory disease 769.34 29.63 213 122318 1179 79620678
Internal injury 744.84 29.63 161 122370 218 79621639
Abortion spontaneous 741.60 29.63 498 122033 29009 79592848
Acute kidney injury 738.25 29.63 12 122519 519392 79102465
Ectopic pregnancy 695.80 29.63 207 122324 1536 79620321
Medical device monitoring error 685.03 29.63 125 122406 0 79621857
Dyspnoea 678.21 29.63 237 122294 856788 78765069
Contraindicated device used 668.59 29.63 122 122409 0 79621857
Uterine leiomyoma 652.68 29.63 276 122255 6167 79615690
Hypomenorrhoea 617.92 29.63 141 122390 283 79621574
Toxicity to various agents 601.90 29.63 9 122522 421531 79200326
Fall 547.39 29.63 57 122474 487572 79134285
Pain 511.79 29.63 2285 120246 701517 78920340
Acne 505.63 29.63 382 122149 26808 79595049
Infertility female 499.79 29.63 120 122411 329 79621528
Hypotension 456.16 29.63 67 122464 440250 79181607
Condition aggravated 449.69 29.63 109 122422 501015 79120842
Menstrual disorder 438 29.63 182 122349 3885 79617972
Device use error 425.07 29.63 211 122320 6890 79614967
Breast pain 420.33 29.63 220 122311 8045 79613812
Breast tenderness 417.90 29.63 150 122381 2118 79619739
Menometrorrhagia 410.94 29.63 113 122418 607 79621250
Neutropenia 402.75 29.63 8 122523 287702 79334155
Drug interaction 399.42 29.63 77 122454 415106 79206751
Uterine pain 398.95 29.63 85 122446 102 79621755
Device placement issue 390.65 29.63 122 122409 1085 79620772
Libido decreased 384.81 29.63 180 122351 5141 79616716
Menstruation delayed 382.74 29.63 125 122406 1301 79620556
Cervical dysplasia 379.74 29.63 138 122393 2023 79619834
Pyrexia 378.92 29.63 294 122237 678415 78943442
Device defective 372.74 29.63 132 122399 1788 79620069
Anaemia 372.32 29.63 111 122420 444904 79176953
Breast cancer female 366.00 29.63 225 122306 11236 79610621
Haemoperitoneum 355.10 29.63 160 122371 4183 79617674
Confusional state 354.40 29.63 38 122493 317959 79303898
Mood swings 346.98 29.63 269 122262 19611 79602246
Off label use 345.83 29.63 539 121992 906676 78715181
Rash 345.52 29.63 233 122298 578125 79043732
Scar 345.09 29.63 241 122290 14955 79606902
Cough 344.43 29.63 72 122459 366717 79255140
Completed suicide 339.36 29.63 8 122523 245759 79376098
Drug hypersensitivity 337.53 29.63 34 122497 298882 79322975
Intra-uterine contraceptive device removal 334.28 29.63 63 122468 12 79621845
Thrombocytopenia 324.91 29.63 21 122510 265238 79356619
Joint swelling 312.82 29.63 38 122493 288608 79333249
Device failure 310.82 29.63 164 122367 6097 79615760
Infusion related reaction 308.59 29.63 10 122521 230227 79391630
Vomiting 299.51 29.63 350 122181 665478 78956379
Drug intolerance 298.27 29.63 30 122501 264089 79357768
Dehydration 288.75 29.63 25 122506 248162 79373695
Abnormal uterine bleeding 283.72 29.63 93 122438 980 79620877
Decreased appetite 283.36 29.63 87 122444 342331 79279526
Fear 274.39 29.63 245 122286 21741 79600116
Nasopharyngitis 273.66 29.63 34 122497 253847 79368010
Depressed mood 271.00 29.63 353 122178 48127 79573730
Renal failure 268.35 29.63 9 122522 200959 79420898
Atrial fibrillation 260.27 29.63 10 122521 197876 79423981
Product dose omission issue 255.30 29.63 38 122493 247499 79374358
Vaginal odour 253.23 29.63 69 122462 356 79621501
Idiopathic intracranial hypertension 248.58 29.63 114 122417 3108 79618749
Disease progression 247.06 29.63 8 122523 184354 79437503
Anhedonia 239.34 29.63 192 122339 14706 79607151
Pancytopenia 238.61 29.63 3 122528 165742 79456115
Migraine 238.27 29.63 458 122073 87035 79534822
Rheumatoid arthritis 237.11 29.63 23 122508 208447 79413410
Drug abuse 233.96 29.63 3 122528 162688 79459169
Hyponatraemia 233.84 29.63 9 122522 177839 79444018
Platelet count decreased 233.69 29.63 17 122514 194647 79427210
Arthropathy 232.74 29.63 9 122522 177102 79444755
Somnolence 232.41 29.63 43 122488 238938 79382919
Respiratory failure 231.74 29.63 11 122520 180900 79440957
Uterine scar 231.51 29.63 46 122485 26 79621831
Sepsis 229.14 29.63 65 122466 269363 79352494
Adnexa uteri pain 228.15 29.63 61 122470 289 79621568
White blood cell count decreased 227.30 29.63 16 122515 188272 79433585
Hypertension 226.25 29.63 113 122418 330879 79290978
Peripheral swelling 225.71 29.63 67 122464 269550 79352307
Pelvic discomfort 225.39 29.63 68 122463 532 79621325
Cardiac arrest 225.28 29.63 9 122522 172087 79449770
Asthenia 224.48 29.63 274 122257 511415 79110442
Overdose 224.27 29.63 15 122516 184191 79437666
Therapeutic product effect decreased 223.61 29.63 6 122525 163857 79458000
Arthralgia 222.78 29.63 334 122197 571469 79050388
Polymenorrhoea 221.90 29.63 76 122455 926 79620931
Intra-abdominal haemorrhage 214.31 29.63 115 122416 4425 79617432
Cardiac failure 206.46 29.63 7 122524 154835 79467022
Stomatitis 205.57 29.63 4 122527 146753 79475104
Blood creatinine increased 203.32 29.63 8 122523 155049 79466808
Meningioma 203.25 29.63 109 122422 4189 79617668
Salpingitis 201.06 29.63 49 122482 146 79621711
Abortion of ectopic pregnancy 200.99 29.63 38 122493 8 79621849
Progesterone receptor assay positive 199.12 29.63 51 122480 197 79621660
Cardiac failure congestive 198.99 29.63 4 122527 142398 79479459
Malaise 197.73 29.63 279 122252 489590 79132267
Renal impairment 197.64 29.63 11 122520 157772 79464085
Erythema 197.15 29.63 50 122481 223240 79398617
Salpingectomy 196.77 29.63 49 122482 164 79621693
Treatment failure 196.00 29.63 18 122513 170468 79451389
Endometritis 193.53 29.63 65 122466 743 79621114
Malignant neoplasm progression 193.40 29.63 3 122528 135987 79485870
Fatigue 190.77 29.63 760 121771 928967 78692890
Hypersensitivity 189.23 29.63 83 122448 262156 79359701
Contraindicated product administered 188.38 29.63 14 122517 157524 79464333
Weight decreased 187.61 29.63 162 122369 355036 79266821
Bacterial vulvovaginitis 186.82 29.63 59 122472 546 79621311
Premenstrual syndrome 186.49 29.63 58 122473 508 79621349
Haemoglobin decreased 184.42 29.63 56 122475 222063 79399794
Constipation 184.01 29.63 103 122428 282947 79338910
Hypokalaemia 183.69 29.63 9 122522 144031 79477826
Pleural effusion 182.33 29.63 10 122521 145252 79476605
Endometriosis 181.85 29.63 96 122435 3572 79618285
Neuropathy peripheral 179.65 29.63 9 122522 141296 79480561
Sinusitis 178.02 29.63 41 122490 195460 79426397
Procedural dizziness 177.42 29.63 40 122491 74 79621783
Hepatic enzyme increased 177.21 29.63 33 122498 182577 79439280
Lower respiratory tract infection 175.30 29.63 5 122526 129215 79492642
Ovarian cyst ruptured 174.64 29.63 63 122468 903 79620954
Therapeutic product effect incomplete 173.98 29.63 11 122520 141634 79480223
Intentional product use issue 172.36 29.63 17 122514 152095 79469762
Product use in unapproved indication 171.72 29.63 85 122446 250274 79371583
Oxygen saturation decreased 171.45 29.63 6 122525 129041 79492816
Oedema peripheral 171.03 29.63 87 122444 252201 79369656
Swelling 168.76 29.63 61 122470 216650 79405207
Retained products of conception 168.11 29.63 39 122492 87 79621770
Pruritus 168.05 29.63 216 122315 394432 79227425
Hypertrichosis 167.76 29.63 66 122465 1216 79620641
Suppressed lactation 166.82 29.63 47 122484 280 79621577
Vulvovaginal pain 166.59 29.63 77 122454 2138 79619719
Oestrogen receptor assay positive 166.39 29.63 47 122484 283 79621574
Uterine cervical pain 164.47 29.63 32 122499 13 79621844
Bacterial vaginosis 164.46 29.63 64 122467 1144 79620713
Vaginal infection 164.08 29.63 106 122425 5774 79616083
Intentional medical device removal by patient 163.37 29.63 48 122483 339 79621518
Haemorrhagic ovarian cyst 162.48 29.63 54 122477 596 79621261
Blood pressure increased 162.04 29.63 61 122470 211299 79410558
Psychological trauma 161.86 29.63 66 122465 1340 79620517
Musculoskeletal stiffness 160.74 29.63 36 122495 174972 79446885
Breast cancer 159.97 29.63 227 122304 33554 79588303
Wound 159.45 29.63 4 122527 116175 79505682
Uterine infection 157.78 29.63 44 122487 251 79621606
Pain in extremity 156.77 29.63 198 122333 364340 79257517
Diffuse alopecia 155.69 29.63 58 122473 915 79620942
Myocardial infarction 155.42 29.63 45 122486 184084 79437773
Chest pain 154.89 29.63 124 122407 282180 79339677
Nausea 154.65 29.63 853 121678 956343 78665514
Pelvic fluid collection 154.03 29.63 55 122476 764 79621093
Pelvic adhesions 153.07 29.63 43 122488 253 79621604
Wheezing 153 29.63 6 122525 116658 79505199
Multiple organ dysfunction syndrome 151.77 29.63 8 122523 120238 79501619
Tubo-ovarian abscess 151.22 29.63 44 122487 299 79621558
Hyperkalaemia 149.63 29.63 6 122525 114392 79507465
Gait disturbance 149.15 29.63 66 122465 207440 79414417
Mood altered 147.94 29.63 159 122372 17688 79604169
Device malfunction 145.24 29.63 172 122359 21276 79600581
Bradycardia 141.57 29.63 20 122511 135537 79486320
Cardio-respiratory arrest 140.89 29.63 6 122525 108504 79513353
Irritability 140.85 29.63 238 122293 40906 79580951
Intentional overdose 140.50 29.63 5 122526 105955 79515902
Systemic lupus erythematosus 138.67 29.63 13 122518 121136 79500721
Pemphigus 138.31 29.63 3 122528 99579 79522278
Hydrometra 137.88 29.63 29 122502 31 79621826
Hypoxia 136.45 29.63 5 122526 103238 79518619
Rhabdomyolysis 136.28 29.63 5 122526 103126 79518731
Hirsutism 135.96 29.63 58 122473 1324 79620533
COVID-19 135.92 29.63 37 122494 157637 79464220
Contusion 135.82 29.63 31 122500 148745 79473112
Leukopenia 134.71 29.63 12 122519 116501 79505356
Injection site pain 133.63 29.63 20 122511 129818 79492039
Depressed level of consciousness 130.14 29.63 4 122527 96648 79525209
Alanine aminotransferase increased 129.57 29.63 44 122487 162526 79459331
Presyncope 129.44 29.63 229 122302 40825 79581032
Hypoglycaemia 127.46 29.63 7 122524 101587 79520270
Blood glucose increased 127.28 29.63 14 122517 114961 79506896
Procedural nausea 126.70 29.63 48 122483 795 79621062
Bronchitis 125.89 29.63 24 122507 130620 79491237
Smear cervix abnormal 124.66 29.63 66 122465 2470 79619387
Haematosalpinx 123.22 29.63 23 122508 3 79621854
Pregnancy with implant contraceptive 122.61 29.63 59 122472 1797 79620060
Panic attack 122.52 29.63 168 122363 24048 79597809
Influenza 122.39 29.63 25 122506 129581 79492276
Chlamydial infection 122.24 29.63 42 122489 517 79621340
Arthritis 122.21 29.63 16 122515 114864 79506993
Cellulitis 121.44 29.63 13 122518 109047 79512810
Product shape issue 120.79 29.63 26 122505 34 79621823
Impaired healing 120.34 29.63 3 122528 87652 79534205
Epistaxis 119.91 29.63 15 122516 111500 79510357
Asthma 119.68 29.63 30 122501 135065 79486792
C-reactive protein increased 119.56 29.63 26 122505 129001 79492856
Neutrophil count decreased 119.37 29.63 6 122525 93953 79527904
Muscular weakness 117.26 29.63 50 122481 160679 79461178
Patient-device incompatibility 116.90 29.63 30 122501 117 79621740
Abortion missed 116.89 29.63 51 122480 1232 79620625
Aspartate aminotransferase increased 116.77 29.63 34 122497 138607 79483250
Drug ineffective 116.04 29.63 2314 120217 1078599 78543258
Product use issue 115.25 29.63 92 122439 209730 79412127
Oedema 115.15 29.63 22 122509 119558 79502299
Gynaecological chlamydia infection 115.08 29.63 21 122510 0 79621857
Loop electrosurgical excision procedure 113.47 29.63 24 122507 27 79621830
Septic shock 113.27 29.63 25 122506 122776 79499081
Uterine polyp 112.73 29.63 53 122478 1531 79620326
Inappropriate schedule of product administration 112.12 29.63 33 122498 133595 79488262
Uterine injury 112.10 29.63 24 122507 30 79621827
Productive cough 111.08 29.63 6 122525 88325 79533532
Weight increased 110.34 29.63 767 121764 276619 79345238
Osteoarthritis 109.58 29.63 6 122525 87303 79534554
Cervicitis 109.53 29.63 32 122499 221 79621636
Blister 108.84 29.63 25 122506 119451 79502406
Mobility decreased 108.48 29.63 27 122504 122148 79499709
Vulvovaginal discomfort 108.18 29.63 54 122477 1784 79620073
Peritoneal adhesions 107.05 29.63 34 122497 321 79621536
Uterine enlargement 105.81 29.63 43 122488 865 79620992
Dysphagia 104.62 29.63 29 122502 122107 79499750
Medical device site discomfort 103.99 29.63 30 122501 197 79621660
Herpes zoster 103.88 29.63 11 122520 93072 79528785
Oropharyngeal pain 103.44 29.63 21 122510 109332 79512525
Therapy non-responder 102.78 29.63 11 122520 92294 79529563
Device intolerance 102.70 29.63 25 122506 74 79621783
Mucosal inflammation 102.22 29.63 3 122528 75577 79546280
Cervical polyp 99.95 29.63 27 122504 134 79621723
Hallucination 98.66 29.63 9 122522 85736 79536121
Hepatic function abnormal 98.51 29.63 3 122528 73104 79548753
Hospitalisation 98.16 29.63 14 122517 94222 79527635
Hormone level abnormal 98.12 29.63 52 122479 1950 79619907
Cervix disorder 97.15 29.63 30 122501 256 79621601
Pelvic infection 96.38 29.63 32 122499 352 79621505
Adenomyosis 95.73 29.63 30 122501 270 79621587
Intentional product misuse 94.89 29.63 16 122515 95149 79526708
Pulmonary oedema 94.57 29.63 12 122519 88242 79533615
Agitation 92.57 29.63 20 122511 99695 79522162
Lung disorder 91.24 29.63 9 122522 80548 79541309
Diabetes mellitus 90.81 29.63 8 122523 78382 79543475
Uterine cervical laceration 89.57 29.63 17 122514 4 79621853
Uterine adhesions 88.64 29.63 19 122512 24 79621833
Procedural anxiety 88.32 29.63 36 122495 730 79621127
Hyperglycaemia 87.75 29.63 5 122526 70330 79551527
Encephalopathy 86.58 29.63 4 122527 67393 79554464
Dyspnoea exertional 86.03 29.63 15 122516 87058 79534799
Blood cholesterol increased 85.90 29.63 13 122518 83707 79538150
Heart rate increased 85.77 29.63 39 122492 120685 79501172
Uterine inflammation 85.70 29.63 18 122513 19 79621838
Dry mouth 85.15 29.63 16 122515 88003 79533854
Colposcopy 84.93 29.63 16 122515 3 79621854
Ill-defined disorder 84.34 29.63 4 122527 65871 79555986
Endometrial hyperplasia 84.13 29.63 33 122498 603 79621254
Procedural vomiting 83.83 29.63 35 122496 756 79621101
Abdominal distension 83.58 29.63 385 122146 119265 79502592
Tremor 83.27 29.63 83 122448 170000 79451857
Nasal congestion 83.02 29.63 10 122521 76542 79545315
Blood pressure systolic increased 82.84 29.63 5 122526 66981 79554876
Psoriatic arthropathy 82.63 29.63 11 122520 77988 79543869
Focal nodular hyperplasia 82.58 29.63 34 122497 708 79621149
Genital discharge 82.43 29.63 17 122514 15 79621842
Chronic kidney disease 81.63 29.63 5 122526 66149 79555708
Post abortion haemorrhage 81.47 29.63 20 122511 62 79621795
Hepatic failure 80.75 29.63 3 122528 61209 79560648
Coronary artery disease 80.63 29.63 5 122526 65469 79556388
Injection site erythema 80.56 29.63 12 122519 78185 79543672
Pneumonitis 80.23 29.63 3 122528 60857 79561000
Pregnancy after post coital contraception 79.47 29.63 15 122516 3 79621854
Lactic acidosis 79.32 29.63 8 122523 70351 79551506
Device ineffective 79.08 29.63 23 122508 156 79621701
Acute respiratory failure 78.27 29.63 3 122528 59538 79562319
Gastrointestinal disorder 77.15 29.63 46 122485 122159 79499698
Mental status changes 77.11 29.63 7 122524 66952 79554905
Acute myocardial infarction 76.70 29.63 13 122518 77023 79544834
Chills 76.39 29.63 80 122451 160154 79461703
Drug-induced liver injury 75.90 29.63 7 122524 66110 79555747
Upper respiratory tract infection 75.59 29.63 23 122508 91145 79530712
Colitis 73.81 29.63 12 122519 73295 79548562
Urinary tract infection 73.51 29.63 199 122332 274313 79347544
Gastrointestinal injury 73.39 29.63 34 122497 949 79620908
Rhinorrhoea 73.22 29.63 14 122517 76060 79545797
Abdominal discomfort 73.13 29.63 174 122357 250553 79371304
Uterine tenderness 72.86 29.63 15 122516 13 79621844
Blood pressure fluctuation 72.26 29.63 9 122522 67136 79554721
Gastrooesophageal reflux disease 72.01 29.63 35 122496 104211 79517646
Chlamydia test positive 71.90 29.63 16 122515 27 79621830
Incorrect dose administered 71.88 29.63 15 122516 76615 79545242
Therapeutic response decreased 71.85 29.63 9 122522 66844 79555013
Pregnancy test positive 71.59 29.63 19 122512 87 79621770
Patient dissatisfaction with device 71.24 29.63 13 122518 0 79621857
Haematochezia 71.07 29.63 23 122508 87622 79534235
Human chorionic gonadotropin decreased 71.05 29.63 14 122517 7 79621850
Blood creatine phosphokinase increased 70.78 29.63 9 122522 66081 79555776
Liver injury 70.70 29.63 4 122527 56610 79565247
Cataract 70.19 29.63 7 122524 62113 79559744
Endometrial cancer 69.12 29.63 42 122489 2052 79619805
Red blood cell count decreased 69.04 29.63 5 122526 57508 79564349
Benign hydatidiform mole 69.00 29.63 18 122513 76 79621781
Salpingo-oophoritis 68.94 29.63 19 122512 103 79621754
Inflammation 68.63 29.63 29 122502 93724 79528133
Hepatic adenoma 68.38 29.63 24 122507 316 79621541
Chest discomfort 67.99 29.63 67 122464 137977 79483880
Endometrial thickening 67.62 29.63 23 122508 274 79621583
Maternal exposure during pregnancy 67.55 29.63 66 122465 136472 79485385
Rectal haemorrhage 67.45 29.63 17 122514 76283 79545574
Papilloedema 67.16 29.63 64 122467 6169 79615688
Skin ulcer 67.09 29.63 4 122527 54146 79567711
Cerebrovascular accident 67.01 29.63 84 122447 155208 79466649
Rash maculo-papular 66.96 29.63 5 122526 56073 79565784
Genital pain 66.58 29.63 30 122501 784 79621073
Medical device entrapment 65.76 29.63 12 122519 0 79621857
Uterine contractions abnormal 65.19 29.63 19 122512 130 79621727
Vulvovaginal pruritus 65.06 29.63 44 122487 2589 79619268
Orthostatic hypotension 64.33 29.63 6 122525 56158 79565699
Wrong technique in product usage process 64.27 29.63 17 122514 73858 79547999
Osteoporosis 64.12 29.63 5 122526 54107 79567750
Cerebral haemorrhage 63.88 29.63 7 122524 57666 79564191
Sedation 63.79 29.63 4 122527 51891 79569966
Haematuria 63.49 29.63 14 122517 68822 79553035
Heart rate decreased 63.46 29.63 15 122516 70301 79551556
Adnexa uteri cyst 63.04 29.63 15 122516 39 79621818
Procedural complication 62.46 29.63 69 122462 7914 79613943
Pregnancy on oral contraceptive 62.38 29.63 29 122502 816 79621041
Complication of pregnancy 62.02 29.63 23 122508 358 79621499
Cervical cyst 61.63 29.63 16 122515 66 79621791
Unresponsive to stimuli 61.21 29.63 7 122524 55781 79566076
Vulvovaginal mycotic infection 61.20 29.63 53 122478 4513 79617344
Hypocalcaemia 60.92 29.63 4 122527 49920 79571937
Actinomyces test positive 60.90 29.63 12 122519 6 79621851
Irritable bowel syndrome 60.88 29.63 11 122520 62230 79559627
Breast discharge 60.77 29.63 27 122504 682 79621175
Blood pressure decreased 60.62 29.63 39 122492 99427 79522430
Seborrhoea 60.56 29.63 24 122507 451 79621406
Liver disorder 60.52 29.63 18 122513 72399 79549458
Habitual abortion 60.28 29.63 11 122520 0 79621857
Cervix injury 60.28 29.63 11 122520 0 79621857
White blood cell count increased 59.79 29.63 20 122511 74613 79547244
Abdominal adhesions 59.42 29.63 47 122484 3526 79618331
Cardiac disorder 59.40 29.63 14 122517 65743 79556114
Hepatitis 58.69 29.63 8 122523 55719 79566138
Folliculitis 58.20 29.63 8 122523 55372 79566485
Blood bilirubin increased 58.08 29.63 15 122516 66217 79555640
Dyspepsia 57.98 29.63 49 122482 108638 79513219
Retained placenta or membranes 57.50 29.63 20 122511 256 79621601
Hepatotoxicity 57.47 29.63 6 122525 51346 79570511
Eosinophilia 57.26 29.63 3 122528 45342 79576515
Oligomenorrhoea 56.99 29.63 26 122505 700 79621157
Breast swelling 56.98 29.63 32 122499 1348 79620509
Agranulocytosis 56.79 29.63 3 122528 45027 79576830
Lethargy 56.59 29.63 27 122504 81265 79540592
Fallopian tube disorder 56.54 29.63 22 122509 393 79621464
Anembryonic gestation 56.49 29.63 22 122509 394 79621463
Respiratory tract infection 56.31 29.63 5 122526 48684 79573173
Haematemesis 56.25 29.63 7 122524 52257 79569600
Intentional device use issue 56.18 29.63 14 122517 47 79621810
Toxic epidermal necrolysis 56.13 29.63 3 122528 44578 79577279
Type 2 diabetes mellitus 56.07 29.63 10 122521 57112 79564745
Pulmonary hypertension 55.43 29.63 5 122526 48075 79573782
Acute respiratory distress syndrome 55.38 29.63 3 122528 44064 79577793
Drug eruption 55.18 29.63 3 122528 43932 79577925
Cervix carcinoma stage 0 55.14 29.63 19 122512 236 79621621
Dysphonia 53.61 29.63 11 122520 56861 79564996
Disorientation 53.57 29.63 15 122516 62761 79559096
Seizure 53.51 29.63 133 122398 188701 79433156
Fear of disease 53.45 29.63 30 122501 1262 79620595
Breast cancer in situ 53.35 29.63 27 122504 919 79620938
Cytomegalovirus infection 53.29 29.63 3 122528 42641 79579216
Renal disorder 52.50 29.63 3 122528 42102 79579755
Migraine with aura 52.48 29.63 39 122492 2666 79619191
Cervical conisation 52.18 29.63 10 122521 3 79621854
Hypophagia 51.55 29.63 5 122526 45362 79576495
Cholestasis 51.42 29.63 9 122522 52100 79569757
Musculoskeletal pain 51.18 29.63 49 122482 102305 79519552
Vertigo 51.00 29.63 226 122305 68856 79553001
Cervix haemorrhage uterine 50.84 29.63 11 122520 15 79621842
Progesterone decreased 50.77 29.63 12 122519 30 79621827
Flushing 50.61 29.63 37 122494 88231 79533626
Pancreatitis 50.53 29.63 21 122510 68554 79553303
Uterine haematoma 50.43 29.63 11 122520 16 79621841
Clostridium difficile infection 50.42 29.63 4 122527 42681 79579176
Full blood count abnormal 50.11 29.63 3 122528 40471 79581386
Pelvic organ injury 50.11 29.63 10 122521 6 79621851
Red blood cell sedimentation rate increased 49.82 29.63 6 122525 45936 79575921
Hepatocellular injury 49.72 29.63 7 122524 47586 79574271
Staphylococcal infection 49.61 29.63 14 122517 58281 79563576
Psoriasis 49.51 29.63 39 122492 89548 79532309
Treatment noncompliance 49.50 29.63 10 122521 52258 79569599
Myalgia 49.35 29.63 135 122396 185506 79436351
Uterine fibrosis 49.32 29.63 9 122522 0 79621857
Chlamydial pelvic inflammatory disease 49.32 29.63 9 122522 0 79621857
Fallopian tube perforation 49.32 29.63 9 122522 0 79621857
Tachycardia 48.98 29.63 127 122404 177641 79444216
Product contamination 48.74 29.63 28 122503 1232 79620625
Fibromyalgia 48.55 29.63 19 122512 64321 79557536
Ovarian germ cell teratoma benign 48.46 29.63 12 122519 39 79621818
Insomnia 48.33 29.63 203 122328 244967 79376890
Respiratory disorder 48.29 29.63 6 122525 44850 79577007
Joint stiffness 47.74 29.63 4 122527 40826 79581031
Blood alkaline phosphatase increased 47.71 29.63 19 122512 63645 79558212
Dizziness 47.40 29.63 549 121982 525892 79095965
Ovarian vein thrombosis 47.34 29.63 12 122519 44 79621813
Skin exfoliation 47.33 29.63 13 122518 55087 79566770
Liver function test abnormal 47.09 29.63 20 122511 64455 79557402
Mouth ulceration 47.07 29.63 3 122528 38391 79583466
Genito-pelvic pain/penetration disorder 46.73 29.63 9 122522 3 79621854
Cervix inflammation 46.73 29.63 9 122522 3 79621854
Fallopian tube cyst 46.52 29.63 12 122519 48 79621809
Haematocrit decreased 46.44 29.63 18 122513 61294 79560563
Leukocytosis 46.33 29.63 6 122525 43449 79578408
Invasive ductal breast carcinoma 46.22 29.63 51 122480 5841 79616016
Pelvic haemorrhage 46.19 29.63 15 122516 153 79621704
Cognitive disorder 46.02 29.63 25 122506 69901 79551956
Illness 45.97 29.63 8 122523 46503 79575354
Localised infection 45.88 29.63 3 122528 37572 79584285
Therapy cessation 45.86 29.63 3 122528 37559 79584298
Chloasma 45.85 29.63 11 122520 30 79621827
Loss of personal independence in daily activities 45.82 29.63 54 122477 102526 79519331
Breast discomfort 45.74 29.63 19 122512 405 79621452
Diverticulitis 45.18 29.63 8 122523 45928 79575929
Abortion induced 44.84 29.63 55 122476 7054 79614803
Transaminases increased 44.83 29.63 12 122519 51731 79570126
Injection site pruritus 44.69 29.63 6 122525 42277 79579580
Bone pain 44.54 29.63 15 122516 55727 79566130
Hypercalcaemia 44.29 29.63 4 122527 38426 79583431
Balance disorder 44.20 29.63 52 122479 98805 79523052
Ectopic pregnancy under hormonal contraception 43.84 29.63 8 122523 0 79621857
Biopsy endometrium 43.84 29.63 8 122523 0 79621857
Cervical discharge 43.84 29.63 8 122523 0 79621857
Gastritis 43.78 29.63 10 122521 47983 79573874
Haematoma 43.56 29.63 13 122518 52182 79569675
Caesarean section 43.54 29.63 73 122458 12462 79609395
Bursitis 43.36 29.63 3 122528 35841 79586016
Pain in jaw 43.35 29.63 9 122522 46142 79575715
Haemoptysis 43.15 29.63 16 122515 55983 79565874
Vulvovaginal dryness 43.00 29.63 32 122499 2192 79619665
Papilloma viral infection 42.90 29.63 29 122502 1705 79620152
Endometrial atrophy 42.84 29.63 11 122520 43 79621814
Abnormal withdrawal bleeding 42.64 29.63 11 122520 44 79621813
Injection site swelling 42.64 29.63 10 122521 47122 79574735
Urinary retention 42.28 29.63 17 122514 56613 79565244
Hepatic cirrhosis 41.99 29.63 3 122528 34903 79586954
Blood potassium decreased 41.82 29.63 10 122521 46502 79575355
Injection site reaction 41.63 29.63 16 122515 54769 79567088
Gonorrhoea 41.33 29.63 15 122516 219 79621638
Abortion spontaneous incomplete 41.29 29.63 9 122522 13 79621844
Endometrial hypertrophy 40.92 29.63 14 122517 170 79621687
Anaphylactic reaction 40.81 29.63 41 122490 83702 79538155
Adnexal torsion 40.77 29.63 17 122514 366 79621491
Hepatic steatosis 40.74 29.63 5 122526 37733 79584124
Injection site bruising 40.63 29.63 7 122524 40995 79580862
Pancreatitis acute 40.24 29.63 13 122518 49591 79572266
Subchorionic haemorrhage 40.09 29.63 13 122518 132 79621725
Road traffic accident 40.03 29.63 9 122522 43655 79578202
Suicide attempt 39.97 29.63 41 122490 82891 79538966
Rash pruritic 39.81 29.63 31 122500 71598 79550259
Acne cystic 39.78 29.63 19 122512 569 79621288
Joint range of motion decreased 39.64 29.63 3 122528 33279 79588578
Infertility 39.51 29.63 20 122511 681 79621176
Placenta accreta 38.91 29.63 14 122517 199 79621658
Influenza like illness 38.64 29.63 32 122499 71675 79550182
Negative thoughts 38.49 29.63 25 122506 1374 79620483
Drug dependence 38.19 29.63 8 122523 40761 79581096
Stevens-Johnson syndrome 38.13 29.63 7 122524 39159 79582698
Breast cyst 37.89 29.63 24 122507 1263 79620594
Gastric ulcer 37.84 29.63 4 122527 33901 79587956
Ventricular fibrillation 37.68 29.63 3 122528 31923 79589934
Loss of consciousness 37.63 29.63 132 122399 167811 79454046
Pelvic abscess 37.32 29.63 29 122502 2120 79619737
Sinus tachycardia 37.24 29.63 6 122525 36902 79584955
Therapy interrupted 36.84 29.63 3 122528 31338 79590519
Ascites 36.82 29.63 37 122494 75525 79546332
Underdose 36.77 29.63 4 122527 33147 79588710
Sleep apnoea syndrome 36.65 29.63 6 122525 36472 79585385
Drug withdrawal syndrome 36.52 29.63 5 122526 34713 79587144
Maternal exposure before pregnancy 36.31 29.63 39 122492 4334 79617523
Bacteraemia 36.31 29.63 4 122527 32820 79589037
Electrolyte imbalance 36.18 29.63 3 122528 30878 79590979
Rash erythematous 36.09 29.63 22 122509 57747 79564110
Endometrial disorder 35.94 29.63 18 122513 599 79621258
Head injury 35.70 29.63 7 122524 37362 79584495
Skin lesion 35.70 29.63 10 122521 41834 79580023
Lymphocyte count decreased 35.62 29.63 14 122517 47275 79574582
Atelectasis 35.51 29.63 4 122527 32253 79589604
Memory impairment 35.45 29.63 74 122457 111660 79510197
Dysarthria 35.43 29.63 31 122500 67591 79554266
Viral infection 35.38 29.63 11 122520 43005 79578852
Acute abdomen 35.31 29.63 33 122498 3104 79618753
Menopausal symptoms 35.20 29.63 27 122504 1936 79619921
Ulcer 34.87 29.63 3 122528 29969 79591888
Angina pectoris 34.77 29.63 18 122513 51714 79570143
Cyst 34.67 29.63 70 122461 13770 79608087
Uterine disorder 34.50 29.63 28 122503 2179 79619678
Blood sodium decreased 34.49 29.63 5 122526 33250 79588607
Oral candidiasis 34.37 29.63 3 122528 29625 79592232
Joint injury 34.20 29.63 4 122527 31331 79590526
Dyskinesia 34.15 29.63 13 122518 44760 79577097
Neutrophil count increased 34.04 29.63 3 122528 29393 79592464
Hydrosalpinx 34.03 29.63 7 122524 6 79621851
Blood potassium increased 33.87 29.63 3 122528 29272 79592585
Osteonecrosis 33.87 29.63 4 122527 31091 79590766
Adnexa uteri mass 33.76 29.63 15 122516 379 79621478
Amniotic cavity infection 33.66 29.63 19 122512 808 79621049
Toxic shock syndrome streptococcal 33.38 29.63 11 122520 118 79621739
Uterine cyst 33.38 29.63 14 122517 306 79621551
Disease recurrence 33.32 29.63 13 122518 44096 79577761
Actinomycosis 33.27 29.63 21 122510 1098 79620759
Medical device site pain 33.25 29.63 14 122517 309 79621548
Lymphopenia 33.11 29.63 4 122527 30553 79591304
Adverse drug reaction 32.93 29.63 32 122499 66360 79555497
Premature menopause 32.89 29.63 17 122514 605 79621252
Fear of pregnancy 32.88 29.63 6 122525 0 79621857
Chlamydial cervicitis 32.88 29.63 6 122525 0 79621857
Inadequate lubrication 32.88 29.63 6 122525 0 79621857
Dysgeusia 32.73 29.63 24 122507 57153 79564704
Product prescribing error 32.57 29.63 14 122517 44799 79577058
Acute hepatic failure 32.49 29.63 4 122527 30109 79591748
Oral pain 32.47 29.63 5 122526 31793 79590064
Jaundice 32.39 29.63 21 122510 53328 79568529
Arrhythmia 32.21 29.63 28 122503 61244 79560613
High risk pregnancy 32.11 29.63 10 122521 88 79621769
Basal cell carcinoma 31.76 29.63 9 122522 37366 79584491
Limb injury 31.66 29.63 4 122527 29524 79592333
Emotional disorder 31.65 29.63 69 122462 14318 79607539
Endometrial adenocarcinoma 31.53 29.63 20 122511 1055 79620802
Uterine dilation and curettage 31.49 29.63 16 122515 549 79621308
Crying 31.27 29.63 92 122439 22951 79598906
Ectropion of cervix 31.21 29.63 9 122522 59 79621798
Throat irritation 31.04 29.63 12 122519 40934 79580923
Gait inability 30.88 29.63 27 122504 58890 79562967
Skin laceration 30.87 29.63 4 122527 28958 79592899
Uterine stenosis 30.45 29.63 6 122525 3 79621854
Uterine mass 30.36 29.63 12 122519 224 79621633
Neoplasm malignant 30.30 29.63 6 122525 31804 79590053
Adrenal insufficiency 30.21 29.63 4 122527 28483 79593374
Swelling face 30.21 29.63 39 122492 71173 79550684
Sciatica 30.15 29.63 7 122524 33215 79588642
Multiple sclerosis relapse 30.09 29.63 17 122514 46516 79575341
Pneumothorax 29.98 29.63 4 122527 28319 79593538
Breast mass 29.94 29.63 44 122487 6710 79615147
Angioedema 29.89 29.63 44 122487 75991 79545866
Vulvovaginal swelling 29.88 29.63 14 122517 401 79621456
Lactation disorder 29.87 29.63 12 122519 234 79621623
Ear infection 29.80 29.63 8 122523 34424 79587433
Disseminated intravascular coagulation 29.78 29.63 9 122522 35833 79586024
Affective disorder 29.63 29.63 49 122482 8270 79613587

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC G03AA06 GENITO URINARY SYSTEM AND SEX HORMONES
SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM
HORMONAL CONTRACEPTIVES FOR SYSTEMIC USE
Progestogens and estrogens, fixed combinations
ATC G03AA07 GENITO URINARY SYSTEM AND SEX HORMONES
SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM
HORMONAL CONTRACEPTIVES FOR SYSTEMIC USE
Progestogens and estrogens, fixed combinations
ATC G03AB03 GENITO URINARY SYSTEM AND SEX HORMONES
SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM
HORMONAL CONTRACEPTIVES FOR SYSTEMIC USE
Progestogens and estrogens, sequential preparations
ATC G03AC03 GENITO URINARY SYSTEM AND SEX HORMONES
SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM
HORMONAL CONTRACEPTIVES FOR SYSTEMIC USE
Progestogens
ATC G03AD01 GENITO URINARY SYSTEM AND SEX HORMONES
SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM
HORMONAL CONTRACEPTIVES FOR SYSTEMIC USE
Emergency contraceptives
ATC G03FA10 GENITO URINARY SYSTEM AND SEX HORMONES
SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM
PROGESTOGENS AND ESTROGENS IN COMBINATION
Progestogens and estrogens, fixed combinations
ATC G03FA11 GENITO URINARY SYSTEM AND SEX HORMONES
SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM
PROGESTOGENS AND ESTROGENS IN COMBINATION
Progestogens and estrogens, fixed combinations
ATC G03FB01 GENITO URINARY SYSTEM AND SEX HORMONES
SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM
PROGESTOGENS AND ESTROGENS IN COMBINATION
Progestogens and estrogens, sequential preparations
ATC G03FB09 GENITO URINARY SYSTEM AND SEX HORMONES
SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM
PROGESTOGENS AND ESTROGENS IN COMBINATION
Progestogens and estrogens, sequential preparations
FDA CS M0447349 Progesterone Congeners
MeSH PA D003270 Contraceptive Agents
MeSH PA D003271 Contraceptive Agents, Female
MeSH PA D000080066 Contraceptive Agents, Hormonal
MeSH PA D003278 Contraceptives, Oral, Hormonal
MeSH PA D003280 Contraceptives, Oral, Synthetic
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:49326 synthetic oral contraceptives
CHEBI has role CHEBI:59826 progestins
FDA EPC N0000175602 Progestin
FDA PE N0000175830 Inhibit Ovum Fertilization
FDA EPC N0000175832 Progestin-containing Intrauterine Device

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

DiseaseRelationSNOMED_IDDOID
Contraception indication 13197004
Postmenopausal osteoporosis indication 102447009
Menopausal flushing indication 198436008
Dysmenorrhea indication 266599000
Postcoital contraception indication 268463003
Menorrhagia indication 386692008
Controlled ovarian stimulation indication 732970000
Female hypogonadism syndrome off-label use 16041008
Polycystic ovaries off-label use 69878008
Acne vulgaris off-label use 88616000
Endometriosis off-label use 129103003
Heart valve disorder contraindication 368009 DOID:4079
Hyperlipoproteinemia contraindication 3744001 DOID:1168
Hypocalcemia contraindication 5291005
Congenital heart disease contraindication 13213009
Hypercholesterolemia contraindication 13644009
Amenorrhea contraindication 14302001 DOID:13938
Jaundice contraindication 18165001
Myocardial infarction contraindication 22298006 DOID:5844
Puerperal endometritis contraindication 22399000
Diplopia contraindication 24982008
Retinal hemorrhage contraindication 28998008
Streptococcal septicemia contraindication 29577008
Vaginitis contraindication 30800001 DOID:2170
Ectopic pregnancy contraindication 34801009 DOID:0060329
Depressive disorder contraindication 35489007
Chloasma contraindication 36209000
Inflammation of cervix contraindication 37610005 DOID:2568
Migraine contraindication 37796009 DOID:6364
Congenital uterine anomaly contraindication 37849005
Hypertensive disorder contraindication 38341003 DOID:10763
Disorder of gallbladder contraindication 39621005 DOID:0060262
Hypothyroidism contraindication 40930008 DOID:1459
Body fluid retention contraindication 43498006
Thrombosis of retinal vein contraindication 46085004
Humoral hypercalcemia of malignancy contraindication 47709007
Chronic heart failure contraindication 48447003
Dementia contraindication 52448006
Hepatic porphyria contraindication 55056006 DOID:3133
Systemic lupus erythematosus contraindication 55464009 DOID:9074
Hyperlipidemia contraindication 55822004 DOID:1168
Benign mammary dysplasia contraindication 57993004
Obstructive hyperbilirubinemia contraindication 59848001
Thrombophlebitis contraindication 64156001 DOID:3875
Blood coagulation disorder contraindication 64779008 DOID:1247
Intermenstrual bleeding - irregular contraindication 64996003
Miscarriage with sepsis contraindication 67465009
Diabetes mellitus contraindication 73211009 DOID:9351
Cyst of ovary contraindication 79883001
Hyperglycemia contraindication 80394007 DOID:4195
Epilepsy contraindication 84757009 DOID:1826
Human immunodeficiency virus infection contraindication 86406008 DOID:526
Breast lump contraindication 89164003
Kidney disease contraindication 90708001 DOID:557
Leukemia, disease contraindication 93143009 DOID:1240
Malignant neoplasm of liver contraindication 93870000 DOID:3571
Uterine leiomyoma contraindication 95315005 DOID:13223
Neoplasm of endometrium contraindication 123844007 DOID:1380
Neoplasm of liver contraindication 126851005 DOID:3571
Deep venous thrombosis contraindication 128053003
Seizure disorder contraindication 128613002
Bed-ridden contraindication 160685001
Liver function tests abnormal contraindication 166603001
Mammography abnormal contraindication 168750009
Angina pectoris contraindication 194828000
Asthma contraindication 195967001 DOID:2841
Cerebrovascular accident contraindication 230690007
Pulmonary thromboembolism contraindication 233935004
Thrombophilia contraindication 234467004 DOID:2452
Disease of liver contraindication 235856003 DOID:409
Cholestasis of pregnancy contraindication 235888006
Uterine perforation by intrauterine contraceptive device contraindication 236738001
Endometrial carcinoma contraindication 254878006 DOID:2871
Chorea contraindication 271700006
Anemia contraindication 271737000 DOID:2355
Pregnancy, function contraindication 289908002
Hypertriglyceridemia contraindication 302870006
Abnormal uterine bleeding unrelated to menstrual cycle contraindication 312984006
Functional visual loss contraindication 313165001
Malignant tumor of cervix contraindication 363354003 DOID:4362
Malignant tumor of ovary contraindication 363443007 DOID:2394
Thromboembolic disorder contraindication 371039008
Cardiovascular event risk contraindication 395112001
Disorder of coronary artery contraindication 414024009
Obesity contraindication 414916001 DOID:9970
Estrogen receptor positive tumor contraindication 416053008
Porphyria contraindication 418470004
Bacterial vaginosis contraindication 419760006 DOID:3385
Optic disc edema contraindication 423341008 DOID:146
Family history of malignant neoplasm of breast contraindication 429740004
Hypertensive urgency contraindication 443482000
Carcinoma of female breast contraindication 447782002
Smokes tobacco daily contraindication 449868002
Severe Headache Disorder contraindication
Nonspecific Abnormal Papanicolaou Smear of Cervix contraindication
Uterine Scarring contraindication
Major Surgery with Prolonged Post-Operative Immobilization contraindication
Intrauterine Device Insertion with Acute Vaginitis contraindication
Inflammatory Disease of Female Pelvic Organs contraindication




๐Ÿถ Veterinary Drug Use

None

๐Ÿถ Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

None

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
0.03MG,0.01MG;0.15MG,N/A SEASONIQUE TEVA BRANDED PHARM N021840 May 25, 2006 RX TABLET ORAL 7615545 June 15, 2023 PREVENTION OF PREGNANCY
0.02MG,0.1MG;0.01MG,N/A LOSEASONIQUE TEVA BRANDED PHARM N022262 Oct. 24, 2008 RX TABLET ORAL 7615545 June 15, 2023 PREVENTION OF PREGNANCY
0.03MG,0.01MG;0.15MG,N/A SEASONIQUE TEVA BRANDED PHARM N021840 May 25, 2006 RX TABLET ORAL 7320969 Jan. 30, 2024 PREVENTION OF PREGNANCY IN WOMEN WHO ELECT TO USE ORAL CONTRACEPTIVES AS A METHOD OF CONTRACEPTION
0.02MG,0.15MG;0.025MG,0.15MG;0.03MG,0.15MG;0.01MG,N/A QUARTETTE TEVA BRANDED PHARM N204061 March 28, 2013 RX TABLET ORAL 8450299 Oct. 7, 2025 PREVENTION OF PREGNANCY
0.02MG;0.1MG BALCOLTRA AVION PHARMS N208612 Jan. 9, 2018 RX TABLET ORAL 7838042 June 1, 2027 ADMINISTRATION OF FERROUS BISGLYCINATE TABLETS
0.03MG,0.01MG;0.15MG,N/A SEASONIQUE TEVA BRANDED PHARM N021840 May 25, 2006 RX TABLET ORAL 7855190 Dec. 5, 2028 PREVENTION OF PREGNANCY
0.02MG,0.1MG;0.01MG,N/A LOSEASONIQUE TEVA BRANDED PHARM N022262 Oct. 24, 2008 RX TABLET ORAL 7855190 Dec. 5, 2028 PREVENTION OF PREGNANCY
52MG MIRENA BAYER HLTHCARE N021225 Dec. 6, 2000 RX INTRAUTERINE DEVICE INTRAUTERINE 10561524 Sept. 16, 2029 A METHOD OF POSITIONING AN INTRAUTERINE SYSTEM (IUS) BY DETERMINING A DEPTH OF THE UTERUS, HOLDING AN INSERTER HANDLE WITH ONE HAND, INSERTING THE IUS INTO THE UTERUS, AND RETRACTING A SLIDER ON THE HANDLE TO RELEASE THE IUS INTO THE UTERUS
52MG MIRENA BAYER HLTHCARE N021225 Dec. 6, 2000 RX INTRAUTERINE DEVICE INTRAUTERINE 9615965 Sept. 16, 2029 A METHOD OF POSITIONING AN INTRAUTERINE SYSTEM BY HOLDING AN INSERTER HANDLE WITH ONE HAND, ADVANCING THE INSERTER THROUGH THE CERVIX AND INTO THE UTERUS, AND RETRACTING A SLIDER ON THE HANDLE TO RELEASE THE INTRAUTERINE SYSTEM
13.5MG SKYLA BAYER HLTHCARE N203159 Jan. 9, 2013 RX INTRAUTERINE DEVICE INTRAUTERINE 10561524 Sept. 16, 2029 A METHOD OF POSITIONING AN INTRAUTERINE SYSTEM (IUS) BY DETERMINING A DEPTH OF THE UTERUS, HOLDING AN INSERTER HANDLE WITH ONE HAND, INSERTING THE IUS INTO THE UTERUS, AND RETRACTING A SLIDER ON THE HANDLE TO RELEASE THE IUS INTO THE UTERUS
13.5MG SKYLA BAYER HLTHCARE N203159 Jan. 9, 2013 RX INTRAUTERINE DEVICE INTRAUTERINE 9615965 Sept. 16, 2029 A METHOD OF POSITIONING AN INTRAUTERINE SYSTEM BY HOLDING AN INSERTER HANDLE WITH ONE HAND, ADVANCING THE INSERTER THROUGH THE CERVIX AND INTO THE UTERUS, AND RETRACTING A SLIDER ON THE HANDLE TO RELEASE THE INTRAUTERINE SYSTEM
19.5MG KYLEENA BAYER HLTHCARE N208224 Sept. 16, 2016 RX INTRAUTERINE DEVICE INTRAUTERINE 10561524 Sept. 16, 2029 A METHOD OF POSITIONING AN INTRAUTERINE SYSTEM (IUS) BY DETERMINING A DEPTH OF THE UTERUS, HOLDING AN INSERTER HANDLE WITH ONE HAND, INSERTING THE IUS INTO THE UTERUS, AND RETRACTING A SLIDER ON THE HANDLE TO RELEASE THE IUS INTO THE UTERUS
19.5MG KYLEENA BAYER HLTHCARE N208224 Sept. 16, 2016 RX INTRAUTERINE DEVICE INTRAUTERINE 9615965 Sept. 16, 2029 A METHOD OF POSITIONING AN INTRAUTERINE SYSTEM BY HOLDING AN INSERTER HANDLE WITH ONE HAND, ADVANCING THE INSERTER THROUGH THE CERVIX AND INTO THE UTERUS, AND RETRACTING A SLIDER ON THE HANDLE TO RELEASE THE INTRAUTERINE SYSTEM
52MG LILETTA MEDICINES360 N206229 Feb. 26, 2015 RX INTRAUTERINE DEVICE INTRAUTERINE 11090186 Oct. 24, 2033 A METHOD FOR PREVENTION OF PREGNANCY
52MG LILETTA MEDICINES360 N206229 Feb. 26, 2015 RX INTRAUTERINE DEVICE INTRAUTERINE 10028858 March 22, 2034 A METHOD FOR PREVENTION OF PREGNANCY

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
0.03MG/24HR;0.12MG/24HR TWIRLA AGILE N204017 Feb. 14, 2020 RX SYSTEM TRANSDERMAL Feb. 14, 2023 NEW PRODUCT
0.02MG;0.1MG TYBLUME EXELTIS USA INC N209405 March 30, 2020 RX TABLET ORAL March 30, 2023 NEW DOSAGE FORM
52MG MIRENA BAYER HLTHCARE N021225 Dec. 6, 2000 RX INTRAUTERINE DEVICE INTRAUTERINE Aug. 20, 2023 DOSING REGIMEN EXTENDING THE CONTRACEPTION USE FROM 5 YEARS TO UP TO 6 YEARS
52MG LILETTA MEDICINES360 N206229 Feb. 26, 2015 RX INTRAUTERINE DEVICE INTRAUTERINE June 29, 2026 TREATMENT OF HEAVY MENSTRUAL BLEEDING FOR UP TO 5 YEARS IN PATIENTS WHO CHOOSE INTRAUTERINE CONTRACEPTION AS THEIR METHOD OF CONTRACEPTION

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Progesterone receptor Nuclear hormone receptor AGONIST ED50 12.80 WOMBAT-PK CHEMBL
Glucocorticoid receptor Nuclear hormone receptor Ki 7.17 DRUG MATRIX
Estrogen receptor Nuclear hormone receptor WOMBAT-PK
Sodium-dependent serotonin transporter Transporter Ki 6.23 DRUG MATRIX
Sex hormone-binding globulin Secreted Kd 8.91 CHEMBL
Androgen receptor Transcription factor Ki 8.37 DRUG MATRIX
Progesterone receptor Transcription factor Ki 9.34 DRUG MATRIX

External reference:

IDSource
4018027 VUID
N0000146370 NUI
D00950 KEGG_DRUG
6533-00-2 SECONDARY_CAS_RN
4018023 VANDF
4018027 VANDF
C0023566 UMLSCUI
CHEBI:6443 CHEBI
NOG PDB_CHEM_ID
CHEMBL1389 ChEMBL_ID
CHEMBL2107797 ChEMBL_ID
DB00367 DRUGBANK_ID
D016912 MESH_DESCRIPTOR_UI
13109 PUBCHEM_CID
2881 IUPHAR_LIGAND_ID
3475 INN_ID
5W7SIA7YZW UNII
DB09389 DRUGBANK_ID
6373 RXNORM
180470 MMSL
4974 MMSL
5191 MMSL
d00557 MMSL
d03034 MMSL
001303 NDDF
001304 NDDF
001325 NDDF
109032009 SNOMEDCT_US
126106007 SNOMEDCT_US
126109000 SNOMEDCT_US
82240008 SNOMEDCT_US
D009644 MESH_DESCRIPTOR_UI
2157 INN_ID

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
LILETTA HUMAN PRESCRIPTION DRUG LABEL 1 0023-5858 INTRAUTERINE DEVICE 52 mg INTRAUTERINE NDA 31 sections
LILETTA HUMAN PRESCRIPTION DRUG LABEL 1 0023-5858 INTRAUTERINE DEVICE 52 mg INTRAUTERINE NDA 31 sections
LILETTA HUMAN PRESCRIPTION DRUG LABEL 1 0023-5858 INTRAUTERINE DEVICE 52 mg INTRAUTERINE NDA 31 sections
Option 2 HUMAN OTC DRUG LABEL 1 0113-2003 TABLET 1.50 mg ORAL ANDA 14 sections
Amethyst HUMAN PRESCRIPTION DRUG LABEL 2 0480-3472 TABLET 90 ug ORAL ANDA 24 sections
Amethyst HUMAN PRESCRIPTION DRUG LABEL 2 0480-3472 TABLET 90 ug ORAL ANDA 24 sections
Levonorgestrel HUMAN OTC DRUG LABEL 1 0536-1142 TABLET 1.50 mg ORAL ANDA 14 sections
Emergency Contraceptive HUMAN OTC DRUG LABEL 1 0536-1391 TABLET 1.50 mg ORAL ANDA 13 sections
Levonorgestrel and Ethinyl Estradiol HUMAN PRESCRIPTION DRUG LABEL 2 0591-0295 TABLET 90 ug ORAL ANDA 24 sections
New Day HUMAN OTC DRUG LABEL 1 16714-809 TABLET 1.50 mg ORAL ANDA 12 sections
NEXT CHOICE HUMAN PRESCRIPTION DRUG LABEL 1 21695-443 TABLET 0.75 mg ORAL ANDA 14 sections
Plan B One-Step HUMAN PRESCRIPTION DRUG LABEL 1 21695-973 TABLET 1.50 mg ORAL NDA 25 sections
Levonorgestrel HUMAN PRESCRIPTION DRUG LABEL 1 40032-620 TABLET 1.50 mg ORAL ANDA 24 sections
Levonorgestrel HUMAN PRESCRIPTION DRUG LABEL 1 40032-622 TABLET 1.50 mg ORAL ANDA 8 sections
My Way HUMAN PRESCRIPTION DRUG LABEL 1 43386-620 TABLET 1.50 mg ORAL ANDA 24 sections
My Way HUMAN OTC DRUG LABEL 1 43386-622 TABLET 1.50 mg ORAL ANDA 12 sections
Levonorgestrel HUMAN OTC DRUG LABEL 1 49615-017 TABLET 1.50 mg ORAL ANDA 13 sections
Plan B One-Step HUMAN OTC DRUG LABEL 1 50090-1141 TABLET 1.50 mg ORAL NDA 14 sections
Plan B One-Step HUMAN OTC DRUG LABEL 1 50090-3830 TABLET 1.50 mg ORAL NDA 15 sections
Plan B One-Step HUMAN OTC DRUG LABEL 1 50090-5978 TABLET 1.50 mg ORAL NDA 15 sections
EContra EZ HUMAN OTC DRUG LABEL 1 50102-111 TABLET 1.50 mg ORAL ANDA 9 sections
EContra One-Step Human OTC Drug Label 1 50102-211 TABLET 1.50 mg ORAL ANDA 14 sections
EContra One-Step Human OTC Drug Label 1 50102-211 TABLET 1.50 mg ORAL ANDA 14 sections
Skyla HUMAN PRESCRIPTION DRUG LABEL 1 50419-422 INTRAUTERINE DEVICE 13.50 mg INTRAUTERINE NDA 29 sections
Skyla HUMAN PRESCRIPTION DRUG LABEL 1 50419-422 INTRAUTERINE DEVICE 13.50 mg INTRAUTERINE NDA 29 sections
Skyla HUMAN PRESCRIPTION DRUG LABEL 1 50419-422 INTRAUTERINE DEVICE 13.50 mg INTRAUTERINE NDA 29 sections
Mirena HUMAN PRESCRIPTION DRUG LABEL 1 50419-423 INTRAUTERINE DEVICE 52 mg INTRAUTERINE NDA 29 sections
Mirena HUMAN PRESCRIPTION DRUG LABEL 1 50419-423 INTRAUTERINE DEVICE 52 mg INTRAUTERINE NDA 29 sections
Kyleena HUMAN PRESCRIPTION DRUG LABEL 1 50419-424 INTRAUTERINE DEVICE 19.50 mg INTRAUTERINE NDA 29 sections
Kyleena HUMAN PRESCRIPTION DRUG LABEL 1 50419-424 INTRAUTERINE DEVICE 19.50 mg INTRAUTERINE NDA 29 sections