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) 4 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 0.00 mg/mL Benet LZ, Broccatelli F, Oprea TI
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 110542 23.37 23357 121688 5465 50454614
Device dislocation 34015.90 23.37 8569 136476 12977 50447102
Genital haemorrhage 17726.77 23.37 4041 141004 2533 50457546
Uterine perforation 14421.52 23.37 3403 141642 3012 50457067
Pregnancy with contraceptive device 13119.08 23.37 2898 142147 1181 50458898
Procedural pain 9165.43 23.37 2795 142250 11037 50449042
Complication of device insertion 9058.85 23.37 2316 142729 3725 50456354
Abdominal pain lower 8888.35 23.37 3045 142000 18711 50441368
Embedded device 6588.50 23.37 1547 143498 1290 50458789
Pelvic pain 6473.41 23.37 2040 143005 9173 50450906
Complication associated with device 6081.54 23.37 2077 142968 12578 50447501
Vaginal haemorrhage 6007.87 23.37 2357 142688 22194 50437885
Device difficult to use 5471.24 23.37 1742 143303 8144 50451935
Ectopic pregnancy with contraceptive device 4402.99 23.37 943 144102 200 50459879
Complication of device removal 4051.13 23.37 1135 143910 3029 50457050
Device breakage 3973.95 23.37 1357 143688 8190 50451889
Heavy menstrual bleeding 3610.00 23.37 1438 143607 14099 50445980
Device use issue 3554.20 23.37 873 144172 1056 50459023
Uterine rupture 3486.34 23.37 770 144275 305 50459774
Medical device discomfort 3473.48 23.37 834 144211 843 50459236
Device issue 3277.68 23.37 1443 143602 18529 50441550
Injury 2948.97 23.37 1802 143243 47123 50412956
Post procedural discomfort 2942.08 23.37 659 144386 321 50459758
Amenorrhoea 2792.68 23.37 1013 144032 7471 50452608
Medical device pain 2775.03 23.37 680 144365 807 50459272
Dyspareunia 2293.56 23.37 632 144413 1547 50458532
Emotional distress 1870.93 23.37 1112 143933 27551 50432528
Post procedural haemorrhage 1743.84 23.37 689 144356 6581 50453498
Abdominal pain 1604.52 23.37 2612 142433 233616 50226463
Expired device used 1509.40 23.37 325 144720 78 50460001
Loss of libido 1423.40 23.37 384 144661 839 50459240
Device deployment issue 1368.65 23.37 475 144570 3021 50457058
Uterine spasm 1273.47 23.37 293 144752 197 50459882
Intermenstrual bleeding 1220.12 23.37 524 144521 6290 50453789
Unintentional medical device removal 1216.15 23.37 490 144555 4945 50455134
Ovarian cyst 1176.74 23.37 641 144404 13355 50446724
Diarrhoea 1132.29 23.37 171 144874 588305 49871774
Vaginal discharge 1102.45 23.37 452 144593 4788 50455291
Ruptured ectopic pregnancy 1062.93 23.37 246 144799 176 50459903
Haemorrhage in pregnancy 1043.60 23.37 325 144720 1384 50458695
Menstruation irregular 1012.40 23.37 446 144599 5716 50454363
Dysmenorrhoea 984.47 23.37 367 144678 2943 50457136
Intentional device misuse 981.25 23.37 255 144790 449 50459630
Pneumonia 916.36 23.37 40 145005 378361 50081718
Off label use of device 883.66 23.37 191 144854 50 50460029
Coital bleeding 877.27 23.37 212 144833 225 50459854
Procedural haemorrhage 875.16 23.37 309 144736 2081 50457998
Uterine haemorrhage 855.16 23.37 334 144711 3081 50456998
Dyspnoea 844.47 23.37 262 144783 547346 49912733
Death 838.64 23.37 20 145025 325359 50134720
Uterine cervix stenosis 813.70 23.37 177 144868 53 50460026
Device physical property issue 796.03 23.37 262 144783 1380 50458699
Depression 767.73 23.37 1553 143492 163870 50296209
Pelvic inflammatory disease 766.68 23.37 250 144795 1272 50458807
Ectopic pregnancy 739.84 23.37 271 144774 2056 50458023
Fall 714.72 23.37 68 144977 334864 50125215
Anxiety 698.78 23.37 1559 143486 176047 50284032
Internal injury 666.14 23.37 161 144884 171 50459908
Acne 660.99 23.37 505 144540 19090 50440989
Medical device monitoring error 660.70 23.37 136 144909 0 50460079
Uterine leiomyoma 639.95 23.37 353 144692 7538 50452541
Contraindicated device used 636.41 23.37 131 144914 0 50460079
Hypomenorrhoea 611.41 23.37 159 144886 281 50459798
Breast cancer female 586.99 23.37 318 144727 6544 50453535
Acute kidney injury 576.03 23.37 17 145028 228041 50232038
Toxicity to various agents 572.06 23.37 7 145038 212492 50247587
Drug hypersensitivity 556.89 23.37 43 145002 250967 50209112
Joint swelling 533.10 23.37 46 144999 245240 50214839
Libido decreased 527.29 23.37 213 144832 2163 50457916
Drug intolerance 511.06 23.37 29 145016 219075 50241004
Condition aggravated 502.10 23.37 118 144927 296940 50163139
Rash 477.01 23.37 337 144708 437134 50022945
Rheumatoid arthritis 474.86 23.37 26 145019 202524 50257555
Infertility female 472.59 23.37 136 144909 411 50459668
Breast tenderness 462.74 23.37 187 144858 1901 50458178
Uterine pain 456.81 23.37 112 144933 133 50459946
Cough 453.46 23.37 74 144971 241190 50218889
Abortion spontaneous 450.85 23.37 577 144468 41195 50418884
Menstrual disorder 449.15 23.37 229 144816 4141 50455938
Infusion related reaction 437.93 23.37 10 145035 169547 50290532
Hypotension 436.37 23.37 75 144970 235394 50224685
Fatigue 425.61 23.37 871 144174 706730 49753349
Cervical dysplasia 417.19 23.37 189 144856 2596 50457483
Vomiting 414.29 23.37 427 144618 460331 49999748
Nasopharyngitis 414.13 23.37 38 145007 192889 50267190
Intra-uterine contraceptive device removal 414.10 23.37 87 144958 9 50460070
Device use error 409.01 23.37 229 144816 5037 50455042
Mood swings 406.34 23.37 349 144696 15605 50444474
Arthralgia 405.29 23.37 397 144648 438305 50021774
Product dose omission issue 403.33 23.37 33 145012 183805 50276274
Menometrorrhagia 397.63 23.37 132 144913 717 50459362
Breast pain 391.10 23.37 253 144792 7291 50452788
Anaemia 391.05 23.37 119 144926 252337 50207742
Arthropathy 390.59 23.37 14 145031 157892 50302187
Menstruation delayed 390.47 23.37 149 144896 1282 50458797
Confusional state 390.17 23.37 40 145005 185888 50274191
Neutropenia 377.22 23.37 10 145035 147955 50312124
Peripheral swelling 369.82 23.37 71 144974 205865 50254214
Idiopathic intracranial hypertension 366.45 23.37 164 144881 2185 50457894
Pyrexia 358.02 23.37 338 144707 379865 50080214
Therapeutic product effect decreased 355.31 23.37 7 145038 136043 50324036
Contraindicated product administered 352.53 23.37 18 145027 148940 50311139
Swelling 350.79 23.37 74 144971 200798 50259281
Device defective 350.34 23.37 134 144911 1161 50458918
Haemoperitoneum 347.05 23.37 162 144883 2393 50457686
Nausea 346.98 23.37 965 144080 704433 49755646
Dehydration 338.17 23.37 26 145019 152423 50307656
Sinusitis 327.81 23.37 49 144996 170509 50289570
Pemphigus 327.59 23.37 3 145042 120163 50339916
Systemic lupus erythematosus 323.49 23.37 20 145025 140602 50319477
Completed suicide 321.67 23.37 13 145032 131876 50328203
Treatment failure 321.42 23.37 18 145027 137619 50322460
Device placement issue 319.83 23.37 111 144934 705 50459374
Hypersensitivity 319.69 23.37 109 144936 215052 50245027
Drug interaction 318.35 23.37 89 144956 199532 50260547
Off label use 310.61 23.37 554 144491 473872 49986207
Decreased appetite 308.69 23.37 96 144949 200827 50259252
Malaise 295.45 23.37 316 144729 335216 50124863
Somnolence 289.96 23.37 48 144997 154937 50305142
Scar 283.75 23.37 250 144795 11568 50448511
Asthenia 282.51 23.37 299 144746 318743 50141336
Wound 278.01 23.37 5 145040 105789 50354290
Hypertension 274.62 23.37 131 144914 211072 50249007
Pain in extremity 270.42 23.37 231 144814 272634 50187445
Stomatitis 269.62 23.37 4 145041 101340 50358739
Thrombocytopenia 268.96 23.37 27 145018 127646 50332433
Hepatic enzyme increased 267.35 23.37 38 145007 137342 50322737
White blood cell count decreased 267.25 23.37 17 145028 116705 50343374
Vaginal odour 265.24 23.37 83 144962 360 50459719
Febrile neutropenia 263.59 23.37 3 145042 97664 50362415
Renal failure 255.08 23.37 12 145033 106621 50353458
Pain 249.60 23.37 2642 142403 576261 49883818
Injection site pain 248.83 23.37 18 145027 111006 50349073
Pruritus 248.46 23.37 268 144777 283300 50176779
Atrial fibrillation 244.84 23.37 11 145034 101734 50358345
Device failure 244.60 23.37 168 144877 5360 50454719
Erythema 243.40 23.37 60 144985 146354 50313725
Constipation 241.67 23.37 115 144930 185593 50274486
Disease progression 238.73 23.37 8 145037 95858 50364221
Lower respiratory tract infection 236.87 23.37 8 145037 95193 50364886
Hyponatraemia 236.01 23.37 9 145036 96130 50363949
Fear 234.23 23.37 247 144798 14302 50445777
Chlamydial infection 233.28 23.37 68 144977 218 50459861
Musculoskeletal stiffness 233.27 23.37 43 145002 128438 50331641
Abdominal discomfort 233.25 23.37 193 144852 231448 50228631
Maternal exposure during pregnancy 231.98 23.37 84 144961 159694 50300385
Neuropathy peripheral 231.07 23.37 11 145034 96746 50363333
Overdose 229.87 23.37 14 145031 99713 50360366
Pelvic discomfort 227.50 23.37 78 144967 475 50459604
Gait disturbance 226.17 23.37 74 144971 149931 50310148
Pancytopenia 224.89 23.37 3 145042 84027 50376052
Weight decreased 224.41 23.37 183 144862 221062 50239017
Depressed mood 223.84 23.37 372 144673 33651 50426428
Cardiac failure congestive 221.64 23.37 4 145041 84378 50375701
Anhedonia 219.75 23.37 197 144848 9327 50450752
Bacterial vulvovaginitis 218.92 23.37 79 144966 571 50459508
Adnexa uteri pain 217.13 23.37 69 144976 318 50459761
Respiratory failure 215.71 23.37 11 145034 91170 50368909
Platelet count decreased 215.56 23.37 20 145025 100706 50359373
Therapeutic product effect incomplete 213.50 23.37 12 145033 91503 50368576
Contusion 209.20 23.37 35 145010 112148 50347931
Bronchitis 206.91 23.37 27 145018 104132 50355947
Pericarditis 205.58 23.37 4 145041 78685 50381394
Hypokalaemia 203.86 23.37 12 145033 87980 50372099
Uterine scar 202.29 23.37 46 144999 27 50460052
Intra-abdominal haemorrhage 198.57 23.37 106 144939 2114 50457965
Suppressed lactation 197.67 23.37 66 144979 366 50459713
Abortion of ectopic pregnancy 197.57 23.37 42 145003 7 50460072
Polymenorrhoea 197.38 23.37 85 144960 1026 50459053
Progesterone receptor assay positive 195.20 23.37 60 144985 242 50459837
Vaginal infection 193.44 23.37 153 144892 6083 50453996
Pleural effusion 192.13 23.37 10 145035 81444 50378635
Mood altered 190.05 23.37 208 144837 12565 50447514
Premenstrual syndrome 189.83 23.37 70 144975 542 50459537
Cardiac arrest 189.05 23.37 13 145032 83638 50376441
Oedema peripheral 187.52 23.37 110 144935 157851 50302228
Salpingitis 187.50 23.37 56 144989 200 50459879
Intentional medical device removal by patient 187.45 23.37 48 144997 77 50460002
Impaired healing 184.56 23.37 3 145042 69783 50390296
Cardiac failure 183.66 23.37 8 145037 76032 50384047
Sepsis 182.80 23.37 76 144969 132849 50327230
Oxygen saturation decreased 182.76 23.37 6 145039 73242 50386837
Haemoglobin decreased 182.74 23.37 68 144977 127148 50332931
Blood creatinine increased 180.74 23.37 9 145036 76151 50383928
Malignant neoplasm progression 179.86 23.37 3 145042 68121 50391958
Endometritis 177.85 23.37 76 144969 899 50459180
Abnormal uterine bleeding 176.69 23.37 81 144964 1145 50458934
Blood pressure increased 175.36 23.37 81 144964 133051 50327028
Retained products of conception 173.58 23.37 45 145000 78 50460001
Chest pain 172.32 23.37 152 144893 176730 50283349
Salpingectomy 171.27 23.37 49 144996 144 50459935
Arthritis 170.99 23.37 23 145022 86698 50373381
Diffuse alopecia 169.62 23.37 64 144981 532 50459547
Urinary tract infection 169.45 23.37 237 144808 223783 50236296
Loop electrosurgical excision procedure 169.35 23.37 36 145009 6 50460073
Influenza 169.02 23.37 27 145018 89511 50370568
Hypertrichosis 168.83 23.37 74 144971 935 50459144
Smear cervix abnormal 167.38 23.37 102 144943 2639 50457440
Renal impairment 164.64 23.37 14 145031 75647 50384432
Product shape issue 164.05 23.37 39 145006 36 50460043
Migraine 163.31 23.37 531 144514 74749 50385330
Uterine cervical pain 162.04 23.37 35 145010 9 50460070
Endometriosis 162.02 23.37 116 144929 3959 50456120
Vulvovaginal pain 160.73 23.37 92 144953 2113 50457966
Osteoarthritis 160.00 23.37 9 145036 68597 50391482
Injection site erythema 160.00 23.37 15 145030 74921 50385158
Blister 158.46 23.37 27 145018 85391 50374688
Procedural dizziness 158.17 23.37 41 145004 71 50460008
Intentional product use issue 157.51 23.37 18 145027 76900 50383179
Herpes zoster 157.08 23.37 12 145033 70774 50389305
Intentional overdose 156.36 23.37 5 145040 62499 50397580
Meningioma 155.39 23.37 106 144939 3343 50456736
Ovarian cyst ruptured 154.39 23.37 70 144975 963 50459116
Uterine infection 153.53 23.37 50 144995 253 50459826
Product use issue 153.51 23.37 122 144923 149353 50310726
Drug abuse 152.59 23.37 4 145041 59842 50400237
Wheezing 151.61 23.37 6 145039 62041 50398038
Actinomyces test positive 150.11 23.37 33 145012 12 50460067
Cellulitis 148.97 23.37 15 145030 70783 50389296
Coma 148.13 23.37 3 145042 56876 50403203
Oropharyngeal pain 147.88 23.37 23 145022 77778 50382301
Asthma 145.73 23.37 38 145007 89299 50370780
Blood glucose increased 145.27 23.37 17 145028 71307 50388772
Psychological trauma 143.90 23.37 66 144979 934 50459145
Bacterial vaginosis 142.34 23.37 66 144979 959 50459120
Tubo-ovarian abscess 141.73 23.37 48 144997 280 50459799
Haemorrhagic ovarian cyst 140.98 23.37 57 144988 580 50459499
Leukopenia 140.30 23.37 15 145030 67513 50392566
Irritability 139.92 23.37 274 144771 28152 50431927
Mobility decreased 138.29 23.37 30 145015 79918 50380161
Ill-defined disorder 138.06 23.37 4 145041 54650 50405429
Pelvic adhesions 137.53 23.37 47 144998 283 50459796
Device malfunction 137.19 23.37 192 144853 14929 50445150
Oestrogen receptor assay positive 134.94 23.37 50 144995 393 50459686
Pelvic infection 134.70 23.37 45 145000 250 50459829
Dysphagia 134.26 23.37 29 145016 77489 50382590
Hospitalisation 133.97 23.37 18 145027 67919 50392160
Presyncope 133.65 23.37 245 144800 23953 50436126
Cardio-respiratory arrest 132.39 23.37 5 145040 53887 50406192
Gastrointestinal disorder 131.46 23.37 53 144992 94403 50365676
Hirsutism 131.30 23.37 62 144983 941 50459138
Pelvic fluid collection 129.63 23.37 57 144988 726 50459353
Muscular weakness 126.34 23.37 57 144988 94956 50365123
Epistaxis 125.98 23.37 17 145028 63937 50396142
Hydrometra 125.02 23.37 30 145015 30 50460049
Hypoxia 124.71 23.37 5 145040 51118 50408961
Depressed level of consciousness 123.71 23.37 6 145039 51947 50408132
Breast cancer 122.92 23.37 334 144711 42556 50417523
Productive cough 122.60 23.37 7 145038 52687 50407392
Patient-device incompatibility 120.11 23.37 35 145010 112 50459967
Medical device site discomfort 118.05 23.37 38 145007 184 50459895
Upper respiratory tract infection 117.54 23.37 23 145022 65875 50394204
Alanine aminotransferase increased 117.50 23.37 53 144992 88306 50371773
Myocardial infarction 117.45 23.37 54 144991 88973 50371106
Device intolerance 116.70 23.37 29 145016 38 50460041
Gynaecological chlamydia infection 116.47 23.37 26 145019 12 50460067
Oedema 116.09 23.37 29 145016 70152 50389927
Bradycardia 113.84 23.37 23 145022 64403 50395676
Aspartate aminotransferase increased 113.13 23.37 41 145004 77957 50382122
Inappropriate schedule of product administration 112.57 23.37 33 145012 71798 50388281
Panic attack 112.12 23.37 200 144845 19142 50440937
Tremor 111.53 23.37 99 144946 114804 50345275
Pregnancy after post coital contraception 111.25 23.37 24 145021 6 50460073
Hypoglycaemia 111.05 23.37 12 145033 53569 50406510
Chest discomfort 110.78 23.37 64 144981 92658 50367421
Multiple organ dysfunction syndrome 110.37 23.37 9 145036 50328 50409751
Hyperkalaemia 110.03 23.37 7 145038 48082 50411997
Product use in unapproved indication 109.78 23.37 102 144943 115717 50344362
Hormone level abnormal 108.75 23.37 71 144974 2078 50458001
Dry mouth 108.15 23.37 16 145029 56162 50403917
Neutrophil count decreased 107.43 23.37 6 145039 46020 50414059
C-reactive protein increased 107.03 23.37 29 145016 66445 50393634
Diabetes mellitus 106.86 23.37 9 145036 49024 50411055
Heart rate increased 106.43 23.37 44 145001 77206 50382873
Blood cholesterol increased 105.66 23.37 16 145029 55199 50404880
Cataract 104.99 23.37 8 145037 47292 50412787
Procedural nausea 104.99 23.37 48 144997 674 50459405
Vulvovaginal discomfort 104.67 23.37 68 144977 1973 50458106
Gastrooesophageal reflux disease 104.54 23.37 44 145001 76384 50383695
Osteoporosis 104.29 23.37 6 145039 44873 50415206
Haematosalpinx 104.07 23.37 22 145023 3 50460076
Uterine polyp 103.39 23.37 64 144981 1704 50458375
Nasal congestion 102.09 23.37 13 145032 51107 50408972
Mucosal inflammation 101.16 23.37 3 145042 40139 50419940
Rhinorrhoea 100.91 23.37 14 145031 51569 50408510
Hallucination 100.50 23.37 9 145036 46648 50413431
Therapy non-responder 99.45 23.37 14 145031 51008 50409071
Therapeutic response decreased 99.37 23.37 10 145035 47221 50412858
Chloasma 99.35 23.37 22 145023 9 50460070
Uterine adhesions 99.04 23.37 24 145021 26 50460053
Peritoneal adhesions 99.03 23.37 34 145011 208 50459871
Psoriatic arthropathy 98.85 23.37 10 145035 47022 50413057
Irritable bowel syndrome 98.22 23.37 15 145030 51426 50408653
Focal nodular hyperplasia 98.18 23.37 41 145004 456 50459623
Metabolic acidosis 97.48 23.37 3 145042 38822 50421257
Injection site reaction 96.89 23.37 14 145031 50018 50410061
Cervicitis 96.84 23.37 38 145007 355 50459724
Pulmonary oedema 96.40 23.37 13 145032 48925 50411154
Lung disorder 95.53 23.37 9 145036 44790 50415289
Uterine injury 95.51 23.37 24 145021 34 50460045
Dyspnoea exertional 95.44 23.37 16 145029 51217 50408862
Abdominal distension 93.82 23.37 436 144609 72467 50387612
Hepatic adenoma 93.71 23.37 34 145011 250 50459829
Chronic kidney disease 93.40 23.37 5 145040 39766 50420313
Genital pain 92.96 23.37 35 145010 289 50459790
Cervical polyp 92.83 23.37 31 145014 172 50459907
Patient dissatisfaction with device 92.30 23.37 19 145026 0 50460079
Insomnia 91.52 23.37 231 144814 174634 50285445
Rhabdomyolysis 91.36 23.37 5 145040 39022 50421057
Papilloedema 90.50 23.37 77 144968 3396 50456683
Wrong technique in product usage process 89.77 23.37 24 145021 55486 50404593
Flushing 89.40 23.37 40 145005 66975 50393104
Procedural complication 88.73 23.37 88 144957 4735 50455344
Injection site bruising 88.34 23.37 4 145041 36764 50423315
Chills 88.30 23.37 88 144957 96599 50363480
Injection site swelling 87.48 23.37 9 145036 41764 50418315
Cervix injury 87.44 23.37 18 145027 0 50460079
Hyperglycaemia 87.33 23.37 4 145041 36401 50423678
Uterine enlargement 87.27 23.37 48 144997 1018 50459061
Procedural vomiting 87.24 23.37 37 145008 429 50459650
Injection site pruritus 86.49 23.37 8 145037 40403 50419676
Dizziness 85.69 23.37 611 144434 345758 50114321
Chlamydia test positive 85.44 23.37 20 145025 16 50460063
Genital discharge 85.00 23.37 23 145022 51 50460028
Endometrial thickening 84.18 23.37 31 145014 239 50459840
Abortion missed 84.13 23.37 54 144991 1534 50458545
Intentional product misuse 84 23.37 16 145029 46718 50413361
Salpingo-oophoritis 83.98 23.37 26 145019 108 50459971
Folliculitis 83.32 23.37 8 145037 39217 50420862
Agitation 82.78 23.37 25 145020 53359 50406720
Medical device entrapment 82.58 23.37 17 145028 0 50460079
Post abortion haemorrhage 81.89 23.37 21 145024 34 50460045
Gastrointestinal injury 81.84 23.37 36 145009 459 50459620
Dyspepsia 81.81 23.37 56 144989 74041 50386038
Blood pressure systolic increased 81.58 23.37 5 145040 35444 50424635
Septic shock 81.32 23.37 31 145014 57144 50402935
Bone pain 81.10 23.37 18 145027 47211 50412868
Encephalopathy 79.91 23.37 4 145041 33707 50426372
Uterine cervical laceration 79.83 23.37 17 145028 3 50460076
Cervix disorder 79.79 23.37 35 145010 443 50459636
Gonorrhoea 79.66 23.37 24 145021 89 50459990
Endometrial hyperplasia 79.50 23.37 40 145005 702 50459377
Hepatic failure 79.27 23.37 3 145042 32280 50427799
Weight increased 79.21 23.37 906 144139 200985 50259094
Uterine inflammation 79.18 23.37 19 145026 19 50460060
Skin ulcer 78.31 23.37 6 145039 35312 50424767
Mental status changes 78.11 23.37 7 145038 36265 50423814
Colposcopy 77.46 23.37 17 145028 6 50460073
Pregnancy test positive 77.27 23.37 24 145021 101 50459978
Red blood cell count decreased 77.18 23.37 5 145040 33830 50426249
Pain in jaw 76.19 23.37 10 145035 38418 50421661
Uterine tenderness 76.05 23.37 17 145028 8 50460071
Musculoskeletal pain 75.19 23.37 58 144987 72119 50387960
Actinomycosis 74.86 23.37 42 145003 927 50459152
Cardiac disorder 74.57 23.37 16 145029 42963 50417116
Inflammation 74.31 23.37 35 145010 56877 50403202
Respiratory distress 74.30 23.37 3 145042 30486 50429593
Myalgia 74.12 23.37 153 144892 124166 50335913
COVID-19 73.91 23.37 21 145024 46641 50413438
Psoriasis 73.74 23.37 54 144991 68946 50391133
Loss of personal independence in daily activities 73.35 23.37 56 144989 69994 50390085
Benign hydatidiform mole 72.93 23.37 22 145023 82 50459997
Incorrect dose administered 72.70 23.37 24 145021 48390 50411689
Influenza like illness 72.50 23.37 37 145008 57422 50402657
Human chorionic gonadotropin decreased 71.42 23.37 18 145027 26 50460053
Balance disorder 70.69 23.37 59 144986 70531 50389548
Joint stiffness 70.58 23.37 4 145041 30304 50429775
Multiple sclerosis relapse 70.57 23.37 18 145027 42946 50417133
Breast swelling 70.37 23.37 42 145003 1045 50459034
Lethargy 69.97 23.37 27 145018 49405 50410674
Anembryonic gestation 69.87 23.37 33 145012 501 50459578
Diverticulitis 69.87 23.37 7 145038 33175 50426904
Acute respiratory failure 69.58 23.37 3 145042 28779 50431300
Hepatic function abnormal 68.54 23.37 7 145038 32674 50427405
Vulvovaginal pruritus 68.46 23.37 57 144988 2439 50457640
Dysphonia 68.46 23.37 14 145031 38878 50421201
Pneumonitis 68.40 23.37 4 145041 29506 50430573
Penile pain 68.01 23.37 14 145031 0 50460079
Pulmonary hypertension 67.95 23.37 8 145037 33409 50426670
Blood potassium decreased 67.79 23.37 12 145033 36933 50423146
Cerebrovascular accident 67.72 23.37 104 144941 94576 50365503
Mouth ulceration 67.48 23.37 3 145042 28021 50432058
Respiratory disorder 67.21 23.37 6 145039 31181 50428898
Chemical poisoning 67.14 23.37 19 145026 53 50460026
No adverse event 66.68 23.37 230 144815 33348 50426731
Coronary artery disease 66.05 23.37 5 145040 29721 50430358
Unresponsive to stimuli 65.66 23.37 6 145039 30603 50429476
Colitis 65.52 23.37 15 145030 38514 50421565
Lactic acidosis 65.36 23.37 9 145036 33346 50426733
Adenomyosis 64.82 23.37 30 145015 434 50459645
Heart rate decreased 64.53 23.37 13 145032 36484 50423595
Endometrial cancer 63.29 23.37 58 144987 2825 50457254
Procedural anxiety 63.24 23.37 33 145012 627 50459452
Orthostatic hypotension 62.65 23.37 6 145039 29475 50430604
Pancreatitis 62.46 23.37 22 145023 42592 50417487
Gastritis 62.10 23.37 10 145035 32973 50427106
Respiratory tract infection 61.89 23.37 9 145036 32008 50428071
Adnexa uteri cyst 61.55 23.37 15 145030 17 50460062
Hypocalcaemia 61.06 23.37 4 145041 26812 50433267
Cognitive disorder 60.97 23.37 25 145020 44098 50415981
Blood pressure fluctuation 60.81 23.37 14 145031 35809 50424270
Pericardial effusion 60.77 23.37 3 145042 25586 50434493
Cervical conisation 60.46 23.37 13 145032 3 50460076
Device ineffective 60.16 23.37 21 145024 136 50459943
Renal disorder 60.06 23.37 5 145040 27500 50432579
Liver function test abnormal 59.86 23.37 26 145019 44313 50415766
Uterine contractions abnormal 59.75 23.37 23 145022 203 50459876
Fibromyalgia 59.74 23.37 27 145018 44951 50415128
Headache 59.57 23.37 1058 143987 505477 49954602
Blood pressure decreased 59.42 23.37 44 145001 55865 50404214
Oligomenorrhoea 59.41 23.37 32 145013 650 50459429
Type 2 diabetes mellitus 59.22 23.37 13 145032 34362 50425717
Intentional device use issue 58.99 23.37 15 145030 23 50460056
Endometrial atrophy 58.67 23.37 17 145028 53 50460026
Acne cystic 58.31 23.37 27 145018 391 50459688
Habitual abortion 58.29 23.37 12 145033 0 50460079
Seborrhoea 58.25 23.37 27 145018 392 50459687
Migraine with aura 58.19 23.37 50 144995 2235 50457844
Rectal haemorrhage 58.09 23.37 19 145026 38539 50421540
Hypophagia 57.99 23.37 6 145039 27722 50432357
Memory impairment 57.89 23.37 86 144959 79274 50380805
Rash maculo-papular 57.75 23.37 5 145040 26636 50433443
Red blood cell sedimentation rate increased 57.49 23.37 8 145037 29408 50430671
White blood cell count increased 56.66 23.37 25 145020 42215 50417864
Hepatotoxicity 56.66 23.37 6 145039 27220 50432859
Drug-induced liver injury 56.45 23.37 7 145038 28088 50431991
Rash pruritic 55.76 23.37 34 145011 47812 50412267
Anaphylactic reaction 55.59 23.37 44 145001 54011 50406068
Breast discharge 55.55 23.37 33 145012 814 50459265
Skin exfoliation 55.36 23.37 14 145031 33598 50426481
Drug eruption 55.33 23.37 3 145042 23603 50436476
Treatment noncompliance 54.87 23.37 10 145035 30140 50429939
Clostridium difficile infection 54.53 23.37 5 145040 25434 50434645
Disorientation 54.32 23.37 17 145028 35467 50424612
Hepatitis 53.97 23.37 12 145033 31441 50428638
Drug withdrawal syndrome 53.58 23.37 5 145040 25076 50435003
Medical device site pain 53.56 23.37 20 145025 161 50459918
Genito-pelvic pain/penetration disorder 53.44 23.37 12 145033 6 50460073
Abdominal pain upper 53.20 23.37 255 144790 159054 50301025
Haematochezia 52.88 23.37 24 145021 39858 50420221
Liver injury 52.84 23.37 5 145040 24801 50435278
Blood alkaline phosphatase increased 52.28 23.37 21 145024 37505 50422574
Fallopian tube disorder 52.11 23.37 22 145023 252 50459827
Seizure 51.88 23.37 169 144876 117705 50342374
Endometrial hypertrophy 51.80 23.37 22 145023 256 50459823
Full blood count abnormal 51.77 23.37 4 145041 23384 50436695
Hypercalcaemia 51.68 23.37 4 145041 23348 50436731
Liver disorder 51.58 23.37 21 145024 37201 50422878
Cervix haemorrhage uterine 51.49 23.37 13 145032 19 50460060
Fear of disease 51.10 23.37 32 145013 870 50459209
Haematemesis 50.88 23.37 9 145036 27716 50432363
Exposure during pregnancy 50.88 23.37 177 144868 120838 50339241
Altered state of consciousness 50.69 23.37 3 145042 21907 50438172
Progesterone decreased 50.66 23.37 17 145028 96 50459983
Swelling face 50.19 23.37 46 144999 52549 50407530
Abdominal adhesions 49.80 23.37 50 144995 2730 50457349
Vulvovaginal mycotic infection 49.51 23.37 63 144982 4466 50455613
Intracranial pressure increased 49.44 23.37 61 144984 4191 50455888
Osteonecrosis 49.43 23.37 4 145041 22513 50437566
Cerebral haemorrhage 49.17 23.37 9 145036 27043 50433036
Throat irritation 49.03 23.37 13 145032 30226 50429853
Tooth disorder 48.76 23.37 6 145039 24222 50435857
Fallopian tube perforation 48.58 23.37 10 145035 0 50460079
Cervical discharge 48.58 23.37 10 145035 0 50460079
Hepatocellular injury 48.55 23.37 8 145037 25939 50434140
Oral pain 48.47 23.37 7 145038 25026 50435053
Staphylococcal infection 47.90 23.37 21 145024 35595 50424484
Adverse drug reaction 47.33 23.37 53 144992 55169 50404910
Pregnancy on oral contraceptive 46.89 23.37 31 145014 927 50459152
Abortion spontaneous incomplete 46.58 23.37 12 145033 20 50460059
Viral infection 46.56 23.37 14 145031 29972 50430107
Haematocrit decreased 46.45 23.37 21 145024 34955 50425124
Dysgeusia 46.27 23.37 27 145018 38889 50421190
Gastric ulcer 46.17 23.37 4 145041 21301 50438778
Ulcer 46.03 23.37 3 145042 20197 50439882
Haematoma 46.02 23.37 15 145030 30495 50429584
Cervix inflammation 45.96 23.37 10 145035 3 50460076
Blood sodium decreased 45.75 23.37 4 145041 21143 50438936
Loss of consciousness 45.65 23.37 150 144895 104203 50355876
Vulvovaginal dryness 45.58 23.37 43 145002 2174 50457905
Cyst 45.51 23.37 105 144940 12082 50447997
Blood creatine phosphokinase increased 45.36 23.37 10 145035 26357 50433722
Tachycardia 45.32 23.37 141 144904 99622 50360457
Abnormal withdrawal bleeding 45.18 23.37 12 145033 24 50460055
Suicide attempt 45.05 23.37 49 144996 51683 50408396
Acute myocardial infarction 44.85 23.37 14 145031 29259 50430820
Negative thoughts 44.77 23.37 29 145016 837 50459242
Oral herpes 44.62 23.37 4 145041 20721 50439358
Adnexal torsion 44.51 23.37 19 145026 224 50459855
Retained placenta or membranes 44.51 23.37 20 145025 269 50459810
Ovarian germ cell teratoma benign 44.51 23.37 15 145030 86 50459993
Leukocytosis 44.46 23.37 6 145039 22573 50437506
Blood lactate dehydrogenase increased 44.30 23.37 3 145042 19559 50440520
Ear pain 44.29 23.37 13 145032 28270 50431809
Skin lesion 44.27 23.37 11 145034 26716 50433363
Expired product administered 43.93 23.37 65 144980 5317 50454762
Agranulocytosis 43.87 23.37 5 145040 21416 50438663
Uterine fibrosis 43.72 23.37 9 145036 0 50460079
Biopsy cervix 43.72 23.37 9 145036 0 50460079
Biopsy endometrium 43.72 23.37 9 145036 0 50460079
Chlamydial pelvic inflammatory disease 43.72 23.37 9 145036 0 50460079
Underdose 43.43 23.37 4 145041 20274 50439805
Rash erythematous 43.14 23.37 23 145022 34829 50425250
Acute respiratory distress syndrome 43.02 23.37 5 145040 21094 50438985
Illness 42.85 23.37 9 145036 24531 50435548
Toxic epidermal necrolysis 42.74 23.37 5 145040 20987 50439092
Cervix carcinoma stage 0 42.27 23.37 20 145025 305 50459774
Pelvic organ injury 42.18 23.37 10 145035 9 50460070
Cervical cyst 41.98 23.37 15 145030 105 50459974
Incorrect route of product administration 41.87 23.37 3 145042 18663 50441416
Eosinophilia 41.83 23.37 3 145042 18649 50441430
Dyskinesia 41.49 23.37 14 145031 27847 50432232
Transaminases increased 41.41 23.37 14 145031 27810 50432269
Blood bilirubin increased 41.36 23.37 20 145025 32018 50428061
Sinus tachycardia 41.28 23.37 6 145039 21348 50438731
Uterine stenosis 41.14 23.37 9 145036 3 50460076
Pregnancy with implant contraceptive 41.14 23.37 39 145006 1984 50458095
Limb injury 40.79 23.37 5 145040 20245 50439834
Breast discomfort 40.58 23.37 21 145024 392 50459687
Infertility 40.51 23.37 24 145021 589 50459490
Hepatic steatosis 40.46 23.37 10 145035 24374 50435705
Papilloma viral infection 40.39 23.37 32 145013 1275 50458804
Cytomegalovirus infection 39.96 23.37 3 145042 17959 50442120
Basal cell carcinoma 39.90 23.37 9 145036 23347 50436732
Dry skin 39.77 23.37 39 145006 43152 50416927
Gastroenteritis 39.71 23.37 9 145036 23272 50436807
Liver function test increased 39.67 23.37 12 145033 25594 50434485
Skin laceration 39.60 23.37 4 145041 18838 50441241
Lymphocyte count decreased 39.56 23.37 13 145032 26294 50433785
Gait inability 39.53 23.37 29 145016 36998 50423081
Bladder perforation 39.51 23.37 15 145030 127 50459952
Pelvic haemorrhage 39.31 23.37 15 145030 129 50459950
Pulmonary mass 39.24 23.37 4 145041 18701 50441378
Chlamydial cervicitis 38.86 23.37 8 145037 0 50460079
Device allergy 38.79 23.37 11 145034 31 50460048
Ear infection 38.76 23.37 13 145032 25957 50434122
Joint range of motion decreased 38.73 23.37 4 145041 18508 50441571
Pulmonary arterial hypertension 38.61 23.37 6 145039 20313 50439766
Haemangioma of liver 38.49 23.37 28 145017 980 50459099
Complication of pregnancy 38.36 23.37 22 145023 507 50459572
Rib fracture 38.10 23.37 5 145040 19216 50440863
Atelectasis 38.09 23.37 4 145041 18266 50441813
Joint injury 38.02 23.37 8 145037 21781 50438298
Device deposit issue 38.02 23.37 9 145036 8 50460071
Sexually transmitted disease 37.84 23.37 16 145029 184 50459895
Fluid retention 37.80 23.37 54 144991 50595 50409484
Head injury 37.68 23.37 11 145034 24009 50436070
Intentional self-injury 37.35 23.37 10 145035 23102 50436977
Affective disorder 37.25 23.37 59 144986 5122 50454957
Oral candidiasis 37.14 23.37 3 145042 16912 50443167
Uterine haematoma 37.01 23.37 10 145035 22 50460057
Cystitis 36.86 23.37 44 145001 44520 50415559
Product contamination 36.84 23.37 22 145023 548 50459531
Toxic shock syndrome streptococcal 36.75 23.37 13 145032 88 50459991
Genital infection bacterial 36.32 23.37 8 145037 3 50460076
Hydrosalpinx 36.32 23.37 8 145037 3 50460076
Hepatic cirrhosis 36.25 23.37 4 145041 17573 50442506
Stevens-Johnson syndrome 35.94 23.37 9 145036 21743 50438336
Disease recurrence 35.82 23.37 7 145038 20074 50440005
Blood potassium increased 35.75 23.37 3 145042 16395 50443684
Cholestasis 35.73 23.37 14 145031 25387 50434692
Laboratory test abnormal 35.73 23.37 11 145034 23197 50436882
Sleep apnoea syndrome 35.53 23.37 12 145033 23856 50436223
Pancreatitis acute 35.40 23.37 12 145033 23800 50436279
Acute abdomen 35.34 23.37 31 145014 1425 50458654
Sciatica 35.03 23.37 9 145036 21373 50438706
Road traffic accident 34.96 23.37 13 145032 24339 50435740
Nodule 34.74 23.37 4 145041 16999 50443080
Haematuria 34.60 23.37 15 145030 25598 50434481
Intervertebral disc protrusion 34.55 23.37 8 145037 20385 50439694
Gastric disorder 34.42 23.37 21 145024 29527 50430552
Dysarthria 34.18 23.37 34 145011 37369 50422710
Depression suicidal 34.03 23.37 31 145014 1498 50458581
Ectopic pregnancy under hormonal contraception 34.00 23.37 7 145038 0 50460079
Persistent urogenital sinus 34.00 23.37 7 145038 0 50460079
Breast cancer in situ 33.80 23.37 30 145015 1401 50458678
Breast cyst 33.77 23.37 31 145014 1513 50458566
Pelvic abscess 33.67 23.37 30 145015 1408 50458671
Fallopian tube cyst 33.55 23.37 13 145032 117 50459962
Spinal fracture 33.54 23.37 3 145042 15570 50444509
Neoplasm malignant 33.48 23.37 13 145032 23702 50436377
Blood glucose decreased 33.22 23.37 6 145039 18205 50441874
Live birth 33.18 23.37 4 145041 16404 50443675
Electrolyte imbalance 32.78 23.37 5 145040 17164 50442915
Uterine cyst 32.22 23.37 18 145027 394 50459685
Toothache 32.08 23.37 5 145040 16889 50443190
Post abortion complication 31.97 23.37 8 145037 11 50460068
Metastases to liver 31.92 23.37 9 145036 20095 50439984
Dry eye 31.91 23.37 27 145018 32068 50428011
Ventricular tachycardia 31.64 23.37 4 145041 15817 50444262
Bronchospasm 31.62 23.37 3 145042 14851 50445228
Procedural headache 31.54 23.37 11 145034 71 50460008
Haemoptysis 31.47 23.37 17 145028 25556 50434523
Urinary retention 31.37 23.37 18 145027 26172 50433907
Angina pectoris 31.37 23.37 18 145027 26170 50433909
Mitral valve incompetence 31.35 23.37 6 145039 17465 50442614
Acute hepatic failure 31.26 23.37 4 145041 15673 50444406
Hypothyroidism 31.21 23.37 31 145014 34094 50425985
Polycystic ovaries 31.10 23.37 37 145008 2447 50457632
Drug dependence 31.09 23.37 9 145036 19750 50440329
Perineal pain 30.94 23.37 15 145030 242 50459837
Metastases to bone 30.60 23.37 7 145038 17988 50442091
Gastroenteritis viral 30.60 23.37 8 145037 18778 50441301
Eye irritation 30.52 23.37 6 145039 17134 50442945
Bacteraemia 30.50 23.37 3 145042 14430 50445649
Macular degeneration 30.38 23.37 3 145042 14385 50445694
Premature menopause 30.29 23.37 22 145023 768 50459311
Osteopenia 30.21 23.37 6 145039 17012 50443067
Conjunctivitis 30.16 23.37 5 145040 16140 50443939
Pulmonary congestion 30.14 23.37 4 145041 15243 50444836
Female genital operation 30.12 23.37 8 145037 16 50460063
Drug ineffective 30.12 23.37 2731 142314 816602 49643477
Cyanosis 29.98 23.37 4 145041 15180 50444899
Small intestinal obstruction 29.96 23.37 5 145040 16063 50444016
Neutrophil count increased 29.87 23.37 3 145042 14192 50445887
Movement disorder 29.71 23.37 7 145038 17625 50442454
Skin discolouration 29.68 23.37 30 145015 32727 50427352
Eye pain 29.44 23.37 23 145022 28426 50431653
Uterine mass 29.37 23.37 15 145030 272 50459807
Genital infection female 29.30 23.37 11 145034 90 50459989
Endometrial disorder 29.22 23.37 20 145025 634 50459445
Product administration error 29.16 23.37 10 145035 19689 50440390
Fallopian tube obstruction 29.15 23.37 6 145039 0 50460079
Inadequate lubrication 29.15 23.37 6 145039 0 50460079
Fear of pregnancy 29.15 23.37 6 145039 0 50460079
Otosclerosis 29.15 23.37 6 145039 0 50460079
Injection site warmth 29.00 23.37 3 145042 13863 50446216
Glaucoma 28.98 23.37 5 145040 15681 50444398
Haemorrhagic cyst 28.92 23.37 13 145032 175 50459904
Lymphadenopathy 28.87 23.37 32 145013 33467 50426612
Lymphopenia 28.82 23.37 5 145040 15616 50444463
Vertigo 28.71 23.37 250 144795 51582 50408497
Vulvovaginal swelling 28.48 23.37 17 145028 423 50459656
Labelled drug-disease interaction medication error 28.38 23.37 12 145033 138 50459941
Hypoaesthesia 28.29 23.37 231 144814 127026 50333053
Ovarian vein thrombosis 28.23 23.37 9 145036 42 50460037
Intervertebral disc degeneration 27.92 23.37 3 145042 13458 50446621
Burning sensation 27.86 23.37 55 144990 45391 50414688
Oesophagitis 27.72 23.37 3 145042 13380 50446699
Abnormal weight gain 27.65 23.37 27 145018 1425 50458654
Infection 27.60 23.37 340 144705 172614 50287465
Lower limb fracture 27.54 23.37 4 145041 14242 50445837
Adrenal insufficiency 27.54 23.37 4 145041 14239 50445840
Prescribed underdose 27.54 23.37 6 145039 15943 50444136
Retinal vein thrombosis 27.43 23.37 16 145029 381 50459698
Respiratory tract congestion 27.42 23.37 4 145041 14195 50445884
Spinal osteoarthritis 27.15 23.37 4 145041 14088 50445991
Feeling hot 27.13 23.37 44 145001 39158 50420921
Hallucination, visual 27.13 23.37 7 145038 16575 50443504
Musculoskeletal disorder 27.12 23.37 8 145037 17341 50442738
Ectropion of cervix 27.09 23.37 9 145036 49 50460030
Weight loss poor 27.06 23.37 22 145023 910 50459169
Adnexa uteri mass 27.05 23.37 17 145028 465 50459614
Ankle fracture 26.97 23.37 6 145039 15716 50444363
Withdrawal bleed 26.91 23.37 8 145037 28 50460051
Human papilloma virus test positive 26.86 23.37 17 145028 471 50459608
Paraesthesia 26.85 23.37 218 144827 120025 50340054
Genital discomfort 26.79 23.37 9 145036 51 50460028
Gilbert's syndrome 26.72 23.37 6 145039 3 50460076
Frequent bowel movements 26.70 23.37 4 145041 13914 50446165
Urticaria 26.65 23.37 240 144805 129321 50330758
Jaundice 26.56 23.37 22 145023 26407 50433672
Hysteroscopy 26.48 23.37 8 145037 30 50460049
Pregnancy 26.42 23.37 160 144885 29417 50430662
Lacrimation increased 26.26 23.37 8 145037 16984 50443095
Uterine dilation and curettage 26.20 23.37 21 145024 851 50459228
Emotional disorder 26.09 23.37 84 144961 11752 50448327
Ectopic pregnancy termination 26.09 23.37 6 145039 4 50460075
Uterine disorder 26.02 23.37 35 145010 2620 50457459
Cholelithiasis 25.92 23.37 43 145002 37930 50422149
Body temperature increased 25.86 23.37 31 145014 31310 50428769
Blood pressure diastolic decreased 25.75 23.37 8 145037 16773 50443306
Pharyngitis 25.71 23.37 9 145036 17494 50442585
Ocular hyperaemia 25.69 23.37 13 145032 20279 50439800
Ovarian abscess 25.30 23.37 12 145033 184 50459895
Heart rate irregular 25.12 23.37 12 145033 19348 50440731
Haemorrhage intracranial 25.06 23.37 3 145042 12371 50447708
Swollen tongue 25.06 23.37 27 145018 28603 50431476
Ascites 25.05 23.37 40 145005 35821 50424258
Placenta accreta 25.01 23.37 12 145033 189 50459890
Hypoacusis 25.01 23.37 14 145031 20633 50439446
Induced abortion haemorrhage 25.00 23.37 6 145039 6 50460073
Infusion site pain 24.99 23.37 3 145042 12343 50447736
Injection site mass 24.93 23.37 7 145038 15673 50444406
Product substitution issue 24.86 23.37 5 145040 14052 50446027
Skin infection 24.84 23.37 3 145042 12288 50447791
Neuralgia 24.83 23.37 16 145029 21847 50438232
Diabetes mellitus inadequate control 24.71 23.37 4 145041 13141 50446938
Sinus disorder 24.63 23.37 11 145034 18447 50441632
Abortion infected 24.61 23.37 7 145038 20 50460059
Breast mass 24.56 23.37 56 144989 6393 50453686
Lactation disorder 24.52 23.37 14 145031 320 50459759
Polyneuropathy 24.42 23.37 3 145042 12128 50447951
Cholecystitis 24.40 23.37 5 145040 13866 50446213
Invasive ductal breast carcinoma 24.33 23.37 53 144992 5868 50454211
Polymenorrhagia 24.32 23.37 8 145037 42 50460037
Genital injury 24.29 23.37 5 145040 0 50460079
Cervix erythema 24.29 23.37 5 145040 0 50460079
Cervical friability 24.29 23.37 5 145040 0 50460079
Product prescribing error 24.27 23.37 15 145030 20946 50439133
Platelet count increased 24.05 23.37 6 145039 14534 50445545
Subchorionic haemorrhage 24.02 23.37 11 145034 155 50459924
Unevaluable event 23.95 23.37 61 144984 46005 50414074
Tricuspid valve incompetence 23.75 23.37 4 145041 12766 50447313
Neck pain 23.61 23.37 84 144961 56983 50403096
Galactorrhoea 23.53 23.37 40 145005 3683 50456396
High risk pregnancy 23.42 23.37 10 145035 118 50459961

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 2950.53 699.26 330 179 1094 29572924

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 83980.76 29.78 16280 97263 4856 64380333
Device dislocation 25553.11 29.78 6169 107374 15009 64370180
Genital haemorrhage 14557.20 29.78 3054 110489 2468 64382721
Uterine perforation 13383.65 29.78 2876 110667 2944 64382245
Pregnancy with contraceptive device 10388.17 29.78 2102 111441 1072 64384117
Complication of device insertion 8089.95 29.78 1855 111688 3157 64382032
Procedural pain 7974.61 29.78 2306 111237 13202 64371987
Abdominal pain lower 7561.69 29.78 2508 111035 23961 64361228
Pelvic pain 5809.46 29.78 1668 111875 9242 64375947
Embedded device 5803.28 29.78 1268 112275 1484 64383705
Vaginal haemorrhage 5096.39 29.78 1726 111817 17618 64367571
Device difficult to use 5006.60 29.78 1451 112092 8347 64376842
Ectopic pregnancy with contraceptive device 4148.88 29.78 808 112735 192 64384997
Injury 3493.38 29.78 1784 111759 54208 64330981
Device issue 3452.50 29.78 1350 112193 21298 64363891
Heavy menstrual bleeding 3414.24 29.78 1137 112406 10940 64374249
Complication of device removal 3397 29.78 849 112694 2431 64382758
Complication associated with device 3223.59 29.78 1152 112391 13928 64371261
Medical device discomfort 3221.78 29.78 706 112837 843 64384346
Device breakage 3221.58 29.78 1007 112536 7748 64377441
Device use issue 3060.31 29.78 698 112845 1135 64384054
Post procedural discomfort 2756.42 29.78 565 112978 338 64384851
Amenorrhoea 2611.54 29.78 801 112742 5738 64379451
Uterine rupture 2472.07 29.78 496 113047 217 64384972
Medical device pain 2434.74 29.78 548 112995 808 64384381
Dyspareunia 2168.87 29.78 525 113018 1252 64383937
Emotional distress 2103.58 29.78 1099 112444 34939 64350250
Abdominal pain 1399.66 29.78 2191 111352 310184 64075005
Device deployment issue 1338.57 29.78 395 113148 2431 64382758
Post procedural haemorrhage 1311.36 29.78 570 112973 11861 64373328
Ovarian cyst 1270.25 29.78 538 113005 10480 64374709
Loss of libido 1248.87 29.78 361 113182 2043 64383146
Haemorrhage in pregnancy 1131.02 29.78 292 113251 988 64384201
Uterine spasm 1095.97 29.78 228 113315 163 64385026
Unintentional medical device removal 1087.39 29.78 419 113124 6315 64378874
Intermenstrual bleeding 1081.06 29.78 388 113155 4737 64380452
Vaginal discharge 1040.62 29.78 354 113189 3643 64381546
Ruptured ectopic pregnancy 1036.29 29.78 217 113326 167 64385022
Dysmenorrhoea 984.42 29.78 303 113240 2194 64382995
Depression 979.52 29.78 1398 112145 181893 64203296
Intentional device misuse 967.73 29.78 227 113316 445 64384744
Anxiety 942.56 29.78 1448 112095 201201 64183988
Menstruation irregular 887.64 29.78 323 113220 4112 64381077
Expired device used 887.24 29.78 183 113360 118 64385071
Pneumonia 840.62 29.78 34 113509 559542 63825647
Diarrhoea 828.97 29.78 140 113403 722564 63662625
Uterine haemorrhage 785.11 29.78 257 113286 2322 64382867
Off label use of device 780.33 29.78 163 113380 122 64385067
Coital bleeding 772.29 29.78 162 113381 127 64385062
Death 761.60 29.78 19 113524 482686 63902503
Procedural haemorrhage 741.93 29.78 280 113263 3972 64381217
Pelvic inflammatory disease 739.24 29.78 208 113335 1050 64384139
Acute kidney injury 735.50 29.78 11 113532 449229 63935960
Internal injury 727.33 29.78 161 113382 208 64384981
Uterine cervix stenosis 705.58 29.78 140 113403 50 64385139
Abortion spontaneous 699.73 29.78 476 113067 24667 64360522
Device physical property issue 663.23 29.78 216 113327 1917 64383272
Ectopic pregnancy 655.75 29.78 199 113344 1365 64383824
Dyspnoea 652.95 29.78 227 113316 718447 63666742
Pain 612.91 29.78 2248 111295 551263 63833926
Toxicity to various agents 607.68 29.78 6 113537 363507 64021682
Uterine leiomyoma 604.87 29.78 258 113285 5111 64380078
Medical device monitoring error 603.93 29.78 113 113430 0 64385189
Hypomenorrhoea 585.63 29.78 134 113409 222 64384967
Contraindicated device used 561.17 29.78 105 113438 0 64385189
Fall 543.55 29.78 53 113490 416773 63968416
Acne 490.64 29.78 371 113172 22710 64362479
Infertility female 485.99 29.78 120 113423 320 64384869
Hypotension 462.67 29.78 62 113481 380912 64004277
Breast cancer female 461.03 29.78 210 113333 4893 64380296
Menstrual disorder 426.96 29.78 176 113367 3189 64382000
Drug interaction 425.46 29.78 65 113478 362018 64023171
Breast pain 421.92 29.78 219 113324 6842 64378347
Device use error 401.93 29.78 206 113337 6265 64378924
Breast tenderness 394.30 29.78 145 113398 1904 64383285
Neutropenia 386.90 29.78 7 113536 239617 64145572
Menometrorrhagia 378.80 29.78 107 113436 549 64384640
Menstruation delayed 375.11 29.78 121 113422 1038 64384151
Libido decreased 373.62 29.78 178 113365 4606 64380583
Condition aggravated 372.73 29.78 98 113445 372328 64012861
Anaemia 372.68 29.78 103 113440 378577 64006612
Uterine pain 367.94 29.78 81 113462 100 64385089
Cervical dysplasia 367.91 29.78 135 113408 1761 64383428
Completed suicide 356.52 29.78 8 113535 224406 64160783
Pyrexia 352.61 29.78 281 113262 558363 63826826
Device defective 347.17 29.78 117 113426 1166 64384023
Scar 342.92 29.78 241 113302 13157 64372032
Confusional state 337.97 29.78 34 113509 261110 64124079
Cough 337.62 29.78 62 113481 302086 64083103
Mood swings 336.76 29.78 265 113278 17203 64367986
Haemoperitoneum 325.20 29.78 152 113391 3763 64381426
Thrombocytopenia 312.02 29.78 21 113522 223780 64161409
Intra-uterine contraceptive device removal 306.95 29.78 59 113484 9 64385180
Device failure 304.55 29.78 164 113379 5528 64379661
Drug hypersensitivity 302.47 29.78 33 113510 237782 64147407
Rash 297.57 29.78 224 113319 458325 63926864
Dehydration 297.39 29.78 22 113521 216741 64168448
Vomiting 289.40 29.78 327 113216 550790 63834399
Migraine 280.83 29.78 441 113102 62236 64322953
Renal failure 279.13 29.78 9 113534 181679 64203510
Device placement issue 270.81 29.78 85 113458 661 64384528
Depressed mood 267.16 29.78 345 113198 40667 64344522
Decreased appetite 264.69 29.78 83 113460 281206 64103983
Fear 261.98 29.78 244 113299 19927 64365262
Off label use 261.71 29.78 446 113097 632360 63752829
Joint swelling 258.92 29.78 36 113507 215346 64169843
Atrial fibrillation 257.51 29.78 10 113533 171079 64214110
Infusion related reaction 253.17 29.78 8 113535 164459 64220730
Vaginal odour 252.31 29.78 67 113476 260 64384929
Idiopathic intracranial hypertension 251.03 29.78 112 113431 2481 64382708
Nasopharyngitis 244.78 29.78 29 113514 196044 64189145
Respiratory failure 244.02 29.78 9 113534 161174 64224015
Product dose omission issue 242.64 29.78 29 113514 194718 64190471
Pancytopenia 236.26 29.78 3 113540 143306 64241883
Cardiac arrest 235.33 29.78 8 113535 154056 64231133
Drug intolerance 234.19 29.78 28 113515 187964 64197225
Somnolence 233.43 29.78 39 113504 203606 64181583
Platelet count decreased 232.94 29.78 16 113527 167695 64217494
Uterine scar 231.40 29.78 46 113497 17 64385172
Anhedonia 228.41 29.78 191 113352 13515 64371674
Overdose 228.27 29.78 13 113530 159553 64225636
Pelvic discomfort 228.10 29.78 68 113475 435 64384754
Sepsis 225.71 29.78 63 113480 230278 64154911
Hyponatraemia 222.11 29.78 9 113534 148330 64236859
Adnexa uteri pain 221.80 29.78 60 113483 254 64384935
Disease progression 221.31 29.78 6 113537 141674 64243515
White blood cell count decreased 219.37 29.78 15 113528 157822 64227367
Rheumatoid arthritis 216.11 29.78 20 113523 164274 64220915
Asthenia 211.60 29.78 266 113277 427778 63957411
Cardiac failure congestive 209.89 29.78 4 113539 130576 64254613
Cardiac failure 205.30 29.78 6 113537 132367 64252822
Blood creatinine increased 204.09 29.78 8 113535 135774 64249415
Polymenorrhoea 199.82 29.78 71 113472 839 64384350
Peripheral swelling 199.76 29.78 60 113483 209093 64176096
Erythema 195.11 29.78 45 113498 187025 64198164
Hypertension 194.73 29.78 107 113436 259154 64126035
Progesterone receptor assay positive 194.53 29.78 51 113492 186 64385003
Renal impairment 193.11 29.78 11 113532 135006 64250183
Bacterial vulvovaginitis 189.22 29.78 58 113485 413 64384776
Abortion of ectopic pregnancy 188.60 29.78 36 113507 4 64385185
Salpingectomy 186.46 29.78 46 113497 122 64385067
Haemoglobin decreased 186.20 29.78 56 113487 195007 64190182
Salpingitis 185.92 29.78 46 113497 124 64385065
Therapeutic product effect decreased 183.53 29.78 4 113539 115347 64269842
Malignant neoplasm progression 183.29 29.78 3 113540 112868 64272321
Pleural effusion 181.96 29.78 10 113533 126549 64258640
Malaise 181.81 29.78 260 113283 395987 63989202
Abnormal uterine bleeding 179.00 29.78 64 113479 771 64384418
Hypokalaemia 177.24 29.78 9 113534 121894 64263295
Arthralgia 176.76 29.78 318 113225 441942 63943247
Arthropathy 175.66 29.78 9 113534 120958 64264231
Diffuse alopecia 175.50 29.78 58 113485 541 64384648
Procedural dizziness 175.34 29.78 38 113505 41 64385148
Vulvovaginal pain 175.13 29.78 77 113466 1645 64383544
Stomatitis 173.60 29.78 4 113539 109601 64275588
Endometritis 172.89 29.78 61 113482 705 64384484
Endometriosis 170.83 29.78 88 113455 2704 64382485
Neuropathy peripheral 169.85 29.78 9 113534 117516 64267673
Ovarian cyst ruptured 169.63 29.78 62 113481 799 64384390
Intra-abdominal haemorrhage 169.06 29.78 99 113444 3932 64381257
Weight decreased 167.27 29.78 154 113389 285585 64099604
Oestrogen receptor assay positive 166.72 29.78 47 113496 239 64384950
Premenstrual syndrome 166.70 29.78 54 113489 470 64384719
Hypertrichosis 166.12 29.78 66 113477 1082 64384107
Retained products of conception 165.38 29.78 39 113504 79 64385110
Suppressed lactation 165.13 29.78 47 113496 249 64384940
Constipation 164.57 29.78 100 113443 229237 64155952
Haemorrhagic ovarian cyst 164.56 29.78 53 113490 452 64384737
Vaginal infection 163.20 29.78 104 113439 4816 64380373
Myocardial infarction 163.04 29.78 45 113498 165776 64219413
Oxygen saturation decreased 162.13 29.78 6 113537 107170 64278019
Oedema peripheral 162.00 29.78 84 113459 210233 64174956
Psychological trauma 161.61 29.78 66 113477 1166 64384023
Uterine infection 160.48 29.78 44 113499 198 64384991
Uterine cervical pain 157.78 29.78 31 113512 9 64385180
Pelvic fluid collection 155.45 29.78 54 113489 594 64384595
Hypersensitivity 155.00 29.78 76 113467 196376 64188813
Fatigue 152.95 29.78 739 112804 747991 63637198
Hyperkalaemia 151.82 29.78 6 113537 101123 64284066
Cardio-respiratory arrest 150.61 29.78 5 113538 98388 64286801
Sinusitis 150.36 29.78 36 113507 145892 64239297
Blood pressure increased 149.99 29.78 58 113485 172494 64212695
Pain in extremity 149.97 29.78 188 113355 302897 64082292
Breast cancer 148.79 29.78 218 113325 28930 64356259
Contraindicated product administered 147.63 29.78 11 113532 107818 64277371
Pelvic adhesions 147.43 29.78 43 113500 252 64384937
Pruritus 147.18 29.78 201 113342 312199 64072990
Bacterial vaginosis 146.41 29.78 56 113487 825 64384364
Multiple organ dysfunction syndrome 145.81 29.78 8 113535 101405 64283784
Nausea 145.63 29.78 802 112741 784998 63600191
Intentional medical device removal by patient 145.33 29.78 43 113500 267 64384922
Injection site pain 145.31 29.78 14 113529 111394 64273795
Hirsutism 144.51 29.78 57 113486 916 64384273
Lower respiratory tract infection 144.14 29.78 5 113538 94609 64290580
Treatment failure 143.95 29.78 18 113525 116798 64268391
Bradycardia 143.79 29.78 19 113524 118200 64266989
Chest pain 143.09 29.78 123 113420 235857 64149332
Mood altered 142.88 29.78 158 113385 15821 64369368
Therapeutic product effect incomplete 140.42 29.78 11 113532 103471 64281718
Gait disturbance 139.79 29.78 64 113479 172091 64213098
Intentional overdose 139.73 29.78 4 113539 89940 64295249
Rhabdomyolysis 139.21 29.78 5 113538 91721 64293468
Tubo-ovarian abscess 137.17 29.78 41 113502 265 64384924
Weight increased 136.66 29.78 738 112805 212610 64172579
Irritability 135.56 29.78 237 113306 36509 64348680
Swelling 134.13 29.78 57 113486 160161 64225028
Hepatic enzyme increased 133.98 29.78 32 113511 129911 64255278
Leukopenia 133.97 29.78 12 113531 101230 64283959
Hypoxia 133.10 29.78 5 113538 88144 64297045
Hypoglycaemia 129.52 29.78 7 113536 89885 64295304
Product use in unapproved indication 129.51 29.78 75 113468 176543 64208646
Meningioma 128.62 29.78 82 113461 3800 64381389
Hydrometra 127.16 29.78 27 113516 24 64385165
Alanine aminotransferase increased 125.42 29.78 44 113499 138987 64246202
Depressed level of consciousness 125.13 29.78 4 113539 81432 64303757
Cellulitis 124.20 29.78 11 113532 93646 64291543
Device malfunction 123.76 29.78 154 113389 17479 64367710
Blood glucose increased 123.59 29.78 14 113529 98059 64287130
Product shape issue 122.51 29.78 26 113517 23 64385166
Bronchitis 121.96 29.78 22 113521 108721 64276468
Intentional product use issue 121.73 29.78 13 113530 95351 64289838
Epistaxis 121.20 29.78 15 113528 98116 64287073
Wound 120.29 29.78 3 113540 76474 64308715
Wheezing 120.21 29.78 5 113538 80574 64304615
Loop electrosurgical excision procedure 120.10 29.78 23 113520 3 64385186
Chlamydial infection 119.92 29.78 40 113503 385 64384804
Drug ineffective 119.72 29.78 2108 111435 838139 63547050
Panic attack 119.15 29.78 165 113378 20788 64364401
Influenza 118.51 29.78 22 113521 106509 64278680
Musculoskeletal stiffness 118.20 29.78 35 113508 123171 64262018
Contusion 115.66 29.78 29 113514 113936 64271253
Aspartate aminotransferase increased 114.97 29.78 34 113509 119754 64265435
Haematosalpinx 114.76 29.78 22 113521 3 64385186
Septic shock 114.70 29.78 23 113520 105414 64279775
Gynaecological chlamydia infection 112.23 29.78 21 113522 0 64385189
Procedural nausea 111.35 29.78 43 113500 651 64384538
Neutrophil count decreased 111.25 29.78 6 113537 77190 64307999
Smear cervix abnormal 109.41 29.78 62 113481 2312 64382877
Uterine injury 108.85 29.78 24 113519 30 64385159
Dysphagia 108.74 29.78 27 113516 106785 64278404
Cervicitis 108.48 29.78 31 113512 167 64385022
Productive cough 104.53 29.78 6 113537 73197 64311992
Oropharyngeal pain 104.05 29.78 16 113527 88851 64296338
Muscular weakness 103.88 29.78 47 113496 127291 64257898
Herpes zoster 103.13 29.78 10 113533 79177 64306012
Uterine polyp 102.65 29.78 49 113494 1273 64383916
Patient-device incompatibility 102.45 29.78 27 113516 101 64385088
Peritoneal adhesions 100.12 29.78 33 113510 305 64384884
Uterine enlargement 99.59 29.78 41 113502 740 64384449
Hepatic function abnormal 99.38 29.78 3 113540 64310 64320879
Abortion missed 98.87 29.78 46 113497 1126 64384063
Medical device site discomfort 98.74 29.78 28 113515 146 64385043
Pelvic infection 98.53 29.78 32 113511 281 64384908
Hallucination 98.01 29.78 8 113535 72780 64312409
Systemic lupus erythematosus 97.98 29.78 11 113532 77601 64307588
Pulmonary oedema 97.22 29.78 12 113531 78662 64306527
Cervical polyp 96.89 29.78 26 113517 106 64385083
Hospitalisation 96.63 29.78 10 113533 75197 64309992
Mucosal inflammation 96.41 29.78 3 113540 62581 64322608
Diabetes mellitus 96.31 29.78 5 113538 66469 64318720
Arthritis 96.08 29.78 16 113527 83798 64301391
Oedema 96.03 29.78 22 113521 91913 64293276
Asthma 95.15 29.78 25 113518 95200 64289989
Vulvovaginal discomfort 95.10 29.78 49 113494 1506 64383683
C-reactive protein increased 94.68 29.78 25 113518 94884 64290305
Agitation 94.62 29.78 20 113523 88347 64296842
Hormone level abnormal 93.33 29.78 50 113493 1667 64383522
Pemphigus 93.19 29.78 3 113540 60698 64324491
Impaired healing 92.80 29.78 3 113540 60470 64324719
Injection site erythema 92.04 29.78 9 113534 70791 64314398
Osteoarthritis 91.02 29.78 5 113538 63331 64321858
Abdominal distension 90.70 29.78 372 113171 95622 64289567
Hyperglycaemia 90.22 29.78 4 113539 60964 64324225
Inappropriate schedule of product administration 88.90 29.78 26 113517 92260 64292929
Uterine cervical laceration 88.09 29.78 17 113526 3 64385186
Device intolerance 87.94 29.78 21 113522 46 64385143
Post abortion haemorrhage 87.83 29.78 20 113523 32 64385157
Tremor 87.70 29.78 79 113464 148151 64237038
Encephalopathy 86.57 29.78 4 113539 58815 64326374
Adenomyosis 86.51 29.78 28 113515 243 64384946
Presyncope 86.45 29.78 191 113352 34898 64350291
Coronary artery disease 86.14 29.78 5 113538 60428 64324761
Uterine adhesions 86.06 29.78 19 113524 24 64385165
Cervix disorder 85.68 29.78 27 113516 213 64384976
Dyspnoea exertional 84.68 29.78 14 113529 73716 64311473
Intentional product misuse 84.67 29.78 13 113530 72282 64312907
Hepatic failure 84.11 29.78 3 113540 55391 64329798
Uterine inflammation 83.26 29.78 18 113525 19 64385170
Focal nodular hyperplasia 82.11 29.78 34 113509 623 64384566
Chronic kidney disease 81.93 29.78 5 113538 57914 64327275
Mental status changes 81.58 29.78 7 113536 61155 64324034
Heart rate increased 81.13 29.78 36 113507 98639 64286550
Genital pain 80.88 29.78 30 113513 404 64384785
Acute myocardial infarction 80.60 29.78 13 113530 69705 64315484
Product use issue 80.42 29.78 89 113454 151626 64233563
Genital discharge 80.12 29.78 17 113526 15 64385174
Endometrial hyperplasia 80.05 29.78 31 113512 473 64384716
Mobility decreased 79.42 29.78 26 113517 85814 64299375
Lactic acidosis 79.32 29.78 8 113535 61402 64323787
Therapy non-responder 79.14 29.78 11 113532 65888 64319301
Chills 79.01 29.78 75 113468 137189 64248000
Procedural vomiting 77.93 29.78 33 113510 641 64384548
Colposcopy 77.43 29.78 15 113528 3 64385186
Lung disorder 75.63 29.78 9 113534 60691 64324498
Pneumonitis 75.54 29.78 3 113540 50362 64334827
Acute respiratory failure 74.80 29.78 3 113540 49931 64335258
Gastrointestinal injury 74.67 29.78 34 113509 791 64384398
Blister 74.08 29.78 25 113518 80942 64304247
Nasal congestion 73.95 29.78 9 113534 59649 64325540
Uterine tenderness 73.13 29.78 15 113528 9 64385180
Vulvovaginal pruritus 73.03 29.78 44 113499 1842 64383347
Procedural anxiety 72.47 29.78 31 113512 618 64384571
Blood creatine phosphokinase increased 72.18 29.78 9 113534 58549 64326640
Chlamydia test positive 72.13 29.78 16 113527 21 64385168
Pregnancy test positive 72.11 29.78 19 113524 71 64385118
Pregnancy after post coital contraception 72.10 29.78 14 113529 3 64385186
Urinary tract infection 71.32 29.78 192 113351 231404 64153785
Human chorionic gonadotropin decreased 71.31 29.78 14 113529 4 64385185
Wrong technique in product usage process 71.02 29.78 14 113529 64960 64320229
Chest discomfort 70.94 29.78 60 113483 116046 64269143
Cerebrovascular accident 70.43 29.78 83 113460 137500 64247689
Benign hydatidiform mole 70.14 29.78 18 113525 59 64385130
Adnexa uteri cyst 69.47 29.78 13 113530 0 64385189
Patient dissatisfaction with device 69.47 29.78 13 113530 0 64385189
Upper respiratory tract infection 69.20 29.78 21 113522 72764 64312425
Red blood cell count decreased 68.97 29.78 4 113539 48382 64336807
Blood pressure systolic increased 67.80 29.78 5 113538 49448 64335741
Endometrial cancer 67.42 29.78 42 113501 1868 64383321
COVID-19 67.20 29.78 16 113527 65124 64320065
Salpingo-oophoritis 67.17 29.78 19 113524 98 64385091
Therapeutic response decreased 66.88 29.78 7 113536 52181 64333008
Unresponsive to stimuli 66.58 29.78 6 113537 50387 64334802
Haematuria 66.16 29.78 13 113530 60458 64324731
Colitis 65.49 29.78 12 113531 58662 64326527
Fallopian tube disorder 65.47 29.78 22 113521 217 64384972
Rhinorrhoea 65.38 29.78 13 113530 59956 64325233
Cataract 65.38 29.78 7 113536 51255 64333934
Hepatic adenoma 65.33 29.78 23 113520 264 64384925
Endometrial thickening 65.21 29.78 21 113522 179 64385010
Cerebral haemorrhage 65.10 29.78 7 113536 51083 64334106
Incorrect dose administered 64.54 29.78 14 113529 60751 64324438
Blood pressure decreased 64.01 29.78 36 113507 86163 64299026
Rash maculo-papular 63.78 29.78 5 113538 47021 64338168
Uterine contractions abnormal 63.67 29.78 19 113524 122 64385067
Vulvovaginal mycotic infection 63.44 29.78 52 113491 3576 64381613
White blood cell count increased 62.84 29.78 19 113524 65995 64319194
Gastrooesophageal reflux disease 62.79 29.78 34 113509 83109 64302080
Papilloedema 62.77 29.78 62 113481 5443 64379746
Seborrhoea 62.29 29.78 24 113519 361 64384828
Rectal haemorrhage 62.19 29.78 16 113527 61801 64323388
Dry mouth 62.02 29.78 15 113528 60403 64324786
Ill-defined disorder 61.71 29.78 4 113539 44048 64341141
Skin ulcer 61.58 29.78 4 113539 43970 64341219
Blood pressure fluctuation 61.49 29.78 9 113534 51862 64333327
Seizure 61.25 29.78 126 113417 166766 64218423
Breast swelling 61.16 29.78 32 113511 1016 64384173
Orthostatic hypotension 60.59 29.78 6 113537 46732 64338457
Lethargy 60.44 29.78 26 113517 72568 64312621
Gastrointestinal disorder 60.36 29.78 42 113501 89667 64295522
Fear of disease 59.66 29.78 30 113513 875 64384314
Blood bilirubin increased 59.64 29.78 14 113529 57539 64327650
Drug-induced liver injury 59.51 29.78 7 113536 47636 64337553
Breast discharge 59.32 29.78 26 113517 551 64384638
Actinomyces test positive 59.27 29.78 12 113531 6 64385183
Disorientation 59.01 29.78 13 113530 55815 64329374
Abdominal adhesions 58.96 29.78 46 113497 2946 64382243
Pregnancy with implant contraceptive 58.88 29.78 35 113508 1429 64383760
Habitual abortion 58.78 29.78 11 113532 0 64385189
Haematemesis 58.47 29.78 7 113536 46992 64338197
Haematochezia 58.15 29.78 22 113521 66351 64318838
Pregnancy on oral contraceptive 58.11 29.78 28 113515 743 64384446
Hypocalcaemia 57.88 29.78 4 113539 41749 64343440
Heart rate decreased 57.85 29.78 13 113530 55054 64330135
Pulmonary hypertension 57.36 29.78 5 113538 43134 64342055
Cardiac disorder 57.01 29.78 14 113529 55802 64329387
Procedural complication 56.76 29.78 67 113476 7198 64377991
Flushing 56.76 29.78 34 113509 78614 64306575
Acute respiratory distress syndrome 56.17 29.78 3 113540 38932 64346257
Oligomenorrhoea 55.81 29.78 25 113518 559 64384630
Hepatocellular injury 55.63 29.78 7 113536 45228 64339961
Osteoporosis 55.62 29.78 5 113538 42075 64343114
Pancreatitis 55.23 29.78 18 113525 59589 64325600
Agranulocytosis 54.99 29.78 3 113540 38226 64346963
Anembryonic gestation 54.91 29.78 22 113521 369 64384820
Eosinophilia 54.73 29.78 3 113540 38073 64347116
Cervix carcinoma stage 0 54.53 29.78 19 113524 211 64384978
Cervical cyst 53.85 29.78 14 113529 49 64385140
Hepatitis 53.82 29.78 8 113535 45574 64339615
Cervix injury 53.44 29.78 10 113533 0 64385189
Medical device entrapment 53.44 29.78 10 113533 0 64385189
Cytomegalovirus infection 53.25 29.78 3 113540 37196 64347993
Toxic epidermal necrolysis 53.20 29.78 3 113540 37163 64348026
Cholestasis 52.70 29.78 8 113535 44864 64340325
Complication of pregnancy 52.02 29.78 20 113523 299 64384890
Breast cancer in situ 51.95 29.78 27 113516 845 64384344
Injection site bruising 51.87 29.78 3 113540 36370 64348819
Device ineffective 51.71 29.78 16 113527 118 64385071
Hypophagia 51.53 29.78 5 113538 39582 64345607
Liver function test abnormal 51.52 29.78 20 113523 59381 64325808
Drug eruption 51.47 29.78 3 113540 36133 64349056
Retained placenta or membranes 51.33 29.78 18 113525 204 64384985
Staphylococcal infection 51.20 29.78 13 113530 50665 64334524
Migraine with aura 50.97 29.78 38 113505 2274 64382915
Progesterone decreased 50.34 29.78 12 113531 26 64385163
Blood cholesterol increased 50.28 29.78 13 113530 50053 64335136
Maternal exposure during pregnancy 49.97 29.78 57 113486 95827 64289362
Ovarian germ cell teratoma benign 49.73 29.78 12 113531 28 64385161
Adnexal torsion 49.69 29.78 17 113526 178 64385011
Hepatotoxicity 49.60 29.78 6 113537 39956 64345233
Injection site swelling 49.42 29.78 7 113536 41346 64343843
Cervix haemorrhage uterine 49.35 29.78 11 113532 15 64385174
Vertigo 49.02 29.78 220 113323 58791 64326398
Pelvic organ injury 48.75 29.78 10 113533 6 64385183
Blood alkaline phosphatase increased 48.72 29.78 19 113524 56260 64328929
Injection site pruritus 48.66 29.78 5 113538 37821 64347368
Dysphonia 48.62 29.78 11 113532 46371 64338818
Clostridium difficile infection 48.61 29.78 4 113539 36159 64349030
Myalgia 48.43 29.78 132 113411 158485 64226704
Treatment noncompliance 48.30 29.78 9 113534 43473 64341716
Uterine fibrosis 48.10 29.78 9 113534 0 64385189
Chlamydial pelvic inflammatory disease 48.10 29.78 9 113534 0 64385189
Haematocrit decreased 48.07 29.78 18 113525 54637 64330552
Psoriatic arthropathy 47.99 29.78 9 113534 43272 64341917
Respiratory tract infection 47.98 29.78 5 113538 37402 64347787
Liver disorder 47.89 29.78 17 113526 53334 64331855
Inflammation 47.44 29.78 28 113515 65272 64319917
Injection site reaction 47.09 29.78 12 113531 46652 64338537
Abdominal discomfort 46.95 29.78 164 113379 182158 64203031
Skin exfoliation 46.35 29.78 11 113532 44874 64340315
Abnormal withdrawal bleeding 46.10 29.78 11 113532 24 64385165
Vulvovaginal dryness 46.03 29.78 31 113512 1577 64383612
Leukocytosis 46.03 29.78 6 113537 37734 64347455
Tachycardia 46.02 29.78 124 113419 149455 64235734
Respiratory disorder 45.87 29.78 5 113538 36106 64349083
Cervical conisation 45.51 29.78 9 113534 3 64385186
Genito-pelvic pain/penetration disorder 45.51 29.78 9 113534 3 64385186
Cervix inflammation 45.51 29.78 9 113534 3 64385186
Mouth ulceration 45.29 29.78 3 113540 32441 64352748
Fallopian tube cyst 44.90 29.78 12 113531 48 64385141
Loss of consciousness 44.89 29.78 124 113419 148241 64236948
Gastritis 44.89 29.78 10 113533 42608 64342581
Bone pain 44.73 29.78 14 113529 47558 64337631
Haematoma 44.59 29.78 13 113530 46237 64338952
Chloasma 44.37 29.78 11 113532 30 64385159
Uterine haematoma 44.30 29.78 10 113533 15 64385174
Breast discomfort 44.23 29.78 18 113525 315 64384874
Suicide attempt 44.22 29.78 36 113507 70971 64314218
Pain in jaw 44.08 29.78 9 113534 40746 64344443
Transaminases increased 43.98 29.78 12 113531 44582 64340607
Papilloma viral infection 43.78 29.78 29 113514 1435 64383754
Blood potassium decreased 43.53 29.78 9 113534 40390 64344799
Haemoptysis 43.39 29.78 16 113527 49032 64336157
Diverticulitis 42.88 29.78 8 113535 38610 64346579
Endometrial atrophy 42.87 29.78 11 113532 36 64385153
Fallopian tube perforation 42.75 29.78 8 113535 0 64385189
Cervical discharge 42.75 29.78 8 113535 0 64385189
Musculoskeletal pain 42.71 29.78 48 113495 81246 64303943
Dyspepsia 42.66 29.78 47 113496 80265 64304924
Balance disorder 42.54 29.78 51 113492 83875 64301314
Infertility 42.53 29.78 20 113523 502 64384687
Urinary retention 41.95 29.78 17 113526 49184 64336005
Invasive ductal breast carcinoma 41.90 29.78 48 113495 4994 64380195
Joint stiffness 41.89 29.78 3 113540 30401 64354788
Psoriasis 41.45 29.78 39 113504 71664 64313525
Pancreatitis acute 41.40 29.78 12 113531 42843 64342346
Abortion spontaneous incomplete 41.39 29.78 9 113534 10 64385179
Full blood count abnormal 40.82 29.78 3 113540 29754 64355435
Hypercalcaemia 40.81 29.78 4 113539 31412 64353777
Pelvic haemorrhage 40.80 29.78 14 113529 148 64385041
Drug withdrawal syndrome 40.61 29.78 4 113539 31287 64353902
Insomnia 40.28 29.78 195 113348 197641 64187548
Endometrial hypertrophy 40.22 29.78 14 113529 155 64385034
Dizziness 40.19 29.78 525 113018 429638 63955551
Gonorrhoea 40.14 29.78 14 113529 156 64385033
Influenza like illness 40.05 29.78 30 113513 61672 64323517
Sinus tachycardia 39.54 29.78 5 113538 32183 64353006
Caesarean section 39.36 29.78 71 113472 11203 64373986
Gastric ulcer 38.88 29.78 4 113539 30230 64354959
Liver injury 38.39 29.78 4 113539 29928 64355261
Breast cyst 38.33 29.78 24 113519 1077 64384112
Osteonecrosis 38.28 29.78 3 113540 28226 64356963
Intentional device use issue 38.24 29.78 9 113534 18 64385171
Head injury 38.23 29.78 6 113537 32836 64352353
Stevens-Johnson syndrome 38.23 29.78 7 113536 34242 64350947
Cognitive disorder 38.11 29.78 25 113518 55062 64330127
Dyskinesia 38.10 29.78 11 113532 39377 64345812
Rash erythematous 38.03 29.78 19 113524 48614 64336575
Anaphylactic reaction 37.79 29.78 39 113504 68625 64316564
Hepatic steatosis 37.64 29.78 5 113538 31002 64354187
Skin lesion 37.55 29.78 9 113534 36473 64348716
Biopsy endometrium 37.41 29.78 7 113536 0 64385189
Hydrosalpinx 37.41 29.78 7 113536 0 64385189
Abortion induced 37.36 29.78 51 113492 6337 64378852
Rash pruritic 37.14 29.78 28 113515 57376 64327813
Endometrial disorder 36.83 29.78 18 113525 493 64384696
Negative thoughts 36.75 29.78 25 113518 1293 64383896
Lymphocyte count decreased 36.47 29.78 13 113530 40686 64344503
Angina pectoris 36.18 29.78 17 113526 45064 64340125
Bacteraemia 36.10 29.78 3 113540 26908 64358281
Uterine disorder 35.95 29.78 28 113515 1789 64383400
Adnexa uteri mass 35.92 29.78 15 113528 281 64384908
Dysarthria 35.91 29.78 31 113512 59375 64325814
Sleep apnoea syndrome 35.77 29.78 5 113538 29827 64355362
Red blood cell sedimentation rate increased 35.70 29.78 6 113537 31229 64353960
Maternal exposure before pregnancy 35.64 29.78 37 113506 3446 64381743
Pelvic abscess 35.57 29.78 28 113515 1817 64383372
Blood sodium decreased 35.21 29.78 5 113538 29477 64355712
Irritable bowel syndrome 35.12 29.78 11 113532 37358 64347831
Hepatic cirrhosis 35.09 29.78 3 113540 26295 64358894
Jaundice 34.96 29.78 21 113522 48491 64336698
Cyst 34.89 29.78 70 113473 11957 64373232
Drug dependence 34.72 29.78 8 113535 33304 64351885
Blood potassium increased 34.57 29.78 3 113540 25977 64359212
Toxic shock syndrome streptococcal 34.55 29.78 11 113532 90 64385099
Acne cystic 34.44 29.78 17 113526 476 64384713
Ascites 34.36 29.78 35 113508 61966 64323223
Ovarian vein thrombosis 34.29 29.78 9 113534 33 64385156
Atelectasis 34.07 29.78 4 113539 27262 64357927
Disease recurrence 33.99 29.78 7 113536 31503 64353686
Electrolyte imbalance 33.36 29.78 3 113540 25240 64359949
Viral infection 33.33 29.78 11 113532 36129 64349060
Swelling face 33.25 29.78 33 113510 59133 64326056
Neutrophil count increased 33.25 29.78 3 113540 25171 64360018
Discomfort 33.17 29.78 250 113293 80628 64304561
Premature menopause 32.86 29.78 17 113526 527 64384662
Road traffic accident 32.82 29.78 7 113536 30738 64354451
Arrhythmia 32.77 29.78 27 113516 52917 64332272
Acute hepatic failure 32.21 29.78 4 113539 26108 64359081
Uterine cyst 32.10 29.78 14 113529 293 64384896
Fear of pregnancy 32.06 29.78 6 113537 0 64385189
Inadequate lubrication 32.06 29.78 6 113537 0 64385189
Chlamydial cervicitis 32.06 29.78 6 113537 0 64385189
Oral pain 32.06 29.78 5 113538 27488 64357701
Type 2 diabetes mellitus 32 29.78 10 113533 34010 64351179
Breast mass 31.97 29.78 43 113500 5267 64379922
Back pain 31.92 29.78 618 112925 249553 64135636
Affective disorder 31.83 29.78 48 113495 6532 64378657
Polycystic ovaries 31.77 29.78 28 113515 2127 64383062
Underdose 31.75 29.78 4 113539 25825 64359364
High risk pregnancy 31.72 29.78 10 113533 79 64385110
Uterine dilation and curettage 31.56 29.78 16 113527 475 64384714
Lymphopenia 31.48 29.78 4 113539 25653 64359536
Actinomycosis 31.46 29.78 20 113523 922 64384267
Abnormal behaviour 31.42 29.78 10 113533 33612 64351577
Disseminated intravascular coagulation 31.35 29.78 9 113534 32339 64352850
Vulvovaginal swelling 31.34 29.78 14 113529 311 64384878
Mitral valve incompetence 31.29 29.78 4 113539 25534 64359655
Subchorionic haemorrhage 31.26 29.78 11 113532 126 64385063
Placenta accreta 31.24 29.78 12 113531 179 64385010
Lactation disorder 31.24 29.78 12 113531 179 64385010
Ventricular fibrillation 31.09 29.78 3 113540 23857 64361332
Basal cell carcinoma 30.98 29.78 8 113535 30830 64354359
Medical device site pain 30.96 29.78 13 113530 247 64384942
Multiple sclerosis relapse 30.79 29.78 17 113526 41118 64344071
Limb injury 30.51 29.78 3 113540 23502 64361687
Hysteroscopy 30.44 29.78 7 113536 12 64385177
Dysgeusia 30.37 29.78 23 113520 47024 64338165
Emotional disorder 30.34 29.78 68 113475 12539 64372650
Oral candidiasis 30.03 29.78 3 113540 23209 64361980
Alopecia 29.84 29.78 433 113110 165257 64219932
Folliculitis 29.84 29.78 8 113535 30069 64355120
Amniotic cavity infection 29.82 29.78 18 113525 756 64384433

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
FDA EPC N0000175602 Progestin
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 PE N0000175830 Inhibit Ovum Fertilization
FDA EPC N0000175832 Progestin-containing Intrauterine Device

Drug Use (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
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
Inflammatory Disease of Female Pelvic Organs contraindication
Nonspecific Abnormal Papanicolaou Smear of Cervix contraindication
Major Surgery with Prolonged Post-Operative Immobilization contraindication
Uterine Scarring contraindication
Intrauterine Device Insertion with Acute Vaginitis 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

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 29 sections
Option 2 HUMAN OTC DRUG LABEL 1 0113-2003 TABLET 1.50 mg ORAL ANDA 14 sections
Levonorgestrel HUMAN OTC DRUG LABEL 1 0536-1142 TABLET 1.50 mg ORAL ANDA 14 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
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
Kyleena HUMAN PRESCRIPTION DRUG LABEL 1 50419-424 INTRAUTERINE DEVICE 19.50 mg INTRAUTERINE NDA 29 sections
Climara Pro HUMAN PRESCRIPTION DRUG LABEL 2 50419-491 PATCH 0.02 mg TRANSDERMAL NDA 30 sections
Dolishale HUMAN PRESCRIPTION DRUG LABEL 2 50742-659 TABLET 90 ug ORAL ANDA 15 sections
Levonorgestrel HUMAN OTC DRUG LABEL 1 51660-723 TABLET 1.50 mg ORAL ANDA 14 sections
Amethyst HUMAN PRESCRIPTION DRUG LABEL 2 52544-295 TABLET 90 ug ORAL ANDA 24 sections
Amethyst HUMAN PRESCRIPTION DRUG LABEL 2 52544-295 TABLET 90 ug ORAL ANDA 24 sections
Next Choice HUMAN PRESCRIPTION DRUG LABEL 1 52959-450 TABLET 0.75 mg ORAL ANDA 24 sections
Plan B HUMAN PRESCRIPTION DRUG LABEL 1 54868-4894 TABLET 0.75 mg ORAL NDA 25 sections
Climara Pro HUMAN PRESCRIPTION DRUG LABEL 2 54868-5570 PATCH 1.39 mg TRANSDERMAL NDA 23 sections
My Way HUMAN OTC DRUG LABEL 1 57297-852 TABLET 1.50 mg ORAL ANDA 9 sections
Fallback Solo HUMAN OTC DRUG LABEL 1 57297-853 TABLET 1.50 mg ORAL ANDA 9 sections