Stem definition | Drug id | CAS RN |
---|---|---|
steroids, progestogens | 2279 | 57-83-0 |
Dose | Unit | Route |
---|---|---|
0.30 | g | O |
5 | mg | P |
0.20 | g | R |
90 | mg | V |
Property | Value | Reference |
---|---|---|
BDDCS (Biopharmaceutical Drug Disposition Classification System) | 2 | Benet LZ, Broccatelli F, Oprea TI |
S (Water solubility) | 0.01 mg/mL | Benet LZ, Broccatelli F, Oprea TI |
EoM (Fraction excreted unchanged in urine) | 0 % | Benet LZ, Broccatelli F, Oprea TI |
MRTD (Maximum Recommended Therapeutic Daily Dose) | 21.20 ยตM/kg/day | Contrera JF, Matthews EJ, Kruhlak NL, Benz RD |
BA (Bioavailability) | 25 % | Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H |
Date | Agency | Company | Orphan |
---|---|---|---|
Feb. 4, 1976 | FDA | ALZA | |
Sept. 27, 2021 | PMDA | FUJI PHARMA CO., LTD. |
MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
---|---|---|---|---|---|---|
Ovarian hyperstimulation syndrome | 850.18 | 12.51 | 219 | 25593 | 3445 | 56262810 |
Temperature regulation disorder | 432.78 | 12.51 | 135 | 25677 | 4333 | 56261922 |
Food allergy | 349.93 | 12.51 | 137 | 25675 | 8687 | 56257568 |
Coeliac disease | 328.92 | 12.51 | 137 | 25675 | 10202 | 56256053 |
Immunodeficiency | 270.41 | 12.51 | 137 | 25675 | 16020 | 56250235 |
Exposure during pregnancy | 267.97 | 12.51 | 321 | 25491 | 136021 | 56130234 |
Bursitis | 216.81 | 12.51 | 143 | 25669 | 27439 | 56238816 |
Foetal exposure during pregnancy | 203.97 | 12.51 | 149 | 25663 | 33674 | 56232581 |
Maternal exposure during pregnancy | 199.68 | 12.51 | 331 | 25481 | 189222 | 56077033 |
Abortion spontaneous | 198.93 | 12.51 | 163 | 25649 | 43590 | 56222665 |
Premature labour | 185.04 | 12.51 | 96 | 25716 | 11786 | 56254469 |
Rash erythematous | 184.77 | 12.51 | 146 | 25666 | 37075 | 56229180 |
Product adhesion issue | 158.18 | 12.51 | 64 | 25748 | 4419 | 56261836 |
Premature delivery | 155.91 | 12.51 | 116 | 25696 | 26944 | 56239311 |
Fluid retention | 150.53 | 12.51 | 153 | 25659 | 53925 | 56212330 |
Hyperhidrosis | 144.26 | 12.51 | 196 | 25616 | 93892 | 56172363 |
Upper respiratory tract infection | 123.94 | 12.51 | 158 | 25654 | 71130 | 56195125 |
Meningioma | 114.76 | 12.51 | 48 | 25764 | 3606 | 56262649 |
Gestational diabetes | 113.76 | 12.51 | 61 | 25751 | 8003 | 56258252 |
Premature baby | 96.70 | 12.51 | 76 | 25736 | 19129 | 56247126 |
Vaginal haemorrhage | 92.94 | 12.51 | 84 | 25728 | 25589 | 56240666 |
Death | 91.74 | 12.51 | 22 | 25790 | 341404 | 55924851 |
Autoimmune dermatitis | 89.12 | 12.51 | 16 | 25796 | 33 | 56266222 |
Headache | 84.23 | 12.51 | 489 | 25323 | 558555 | 55707700 |
Oligohydramnios | 80.80 | 12.51 | 44 | 25768 | 5950 | 56260305 |
Erythema | 80.66 | 12.51 | 203 | 25609 | 155736 | 56110519 |
Butterfly rash | 80.10 | 12.51 | 29 | 25783 | 1477 | 56264778 |
Postmenopausal haemorrhage | 78.54 | 12.51 | 31 | 25781 | 2005 | 56264250 |
Pregnancy | 76.85 | 12.51 | 85 | 25727 | 32948 | 56233307 |
Hot flush | 74.07 | 12.51 | 99 | 25713 | 46627 | 56219628 |
Asthma | 73.80 | 12.51 | 161 | 25651 | 112609 | 56153646 |
Haemorrhage in pregnancy | 71.88 | 12.51 | 28 | 25784 | 1748 | 56264507 |
Premature rupture of membranes | 69.89 | 12.51 | 37 | 25775 | 4728 | 56261527 |
Pre-eclampsia | 66.64 | 12.51 | 44 | 25768 | 8442 | 56257813 |
Placenta accreta | 65.17 | 12.51 | 16 | 25796 | 204 | 56266051 |
Congenital absence of vertebra | 63.64 | 12.51 | 12 | 25800 | 36 | 56266219 |
Toxicity to various agents | 63.23 | 12.51 | 13 | 25799 | 224551 | 56041704 |
Maternal exposure before pregnancy | 60.04 | 12.51 | 38 | 25774 | 6785 | 56259470 |
Progesterone decreased | 58.43 | 12.51 | 13 | 25799 | 104 | 56266151 |
Systemic lupus erythematosus | 58.41 | 12.51 | 7 | 25805 | 180071 | 56086184 |
Ectopic pregnancy | 57.40 | 12.51 | 26 | 25786 | 2368 | 56263887 |
Off label use | 57.34 | 12.51 | 443 | 25369 | 555737 | 55710518 |
Congenital vesicoureteric reflux | 55.90 | 12.51 | 10 | 25802 | 20 | 56266235 |
Glossodynia | 54.55 | 12.51 | 4 | 25808 | 152454 | 56113801 |
Normal newborn | 54.50 | 12.51 | 37 | 25775 | 7433 | 56258822 |
Atrial septal defect | 54.19 | 12.51 | 35 | 25777 | 6471 | 56259784 |
Constipation | 52.37 | 12.51 | 207 | 25605 | 201736 | 56064519 |
Synovitis | 50.55 | 12.51 | 7 | 25805 | 161298 | 56104957 |
Vulvovaginal discomfort | 50.39 | 12.51 | 23 | 25789 | 2132 | 56264123 |
Wound | 48.65 | 12.51 | 4 | 25808 | 138800 | 56127455 |
Acute kidney injury | 48.41 | 12.51 | 25 | 25787 | 240738 | 56025517 |
Drug hypersensitivity | 47.41 | 12.51 | 250 | 25562 | 274955 | 55991300 |
Abortion threatened | 46.46 | 12.51 | 15 | 25797 | 538 | 56265717 |
Periorbital oedema | 45.58 | 12.51 | 29 | 25783 | 5225 | 56261030 |
Pneumonia | 44.45 | 12.51 | 74 | 25738 | 407024 | 55859231 |
Ovarian enlargement | 44.16 | 12.51 | 14 | 25798 | 473 | 56265782 |
Subdural hygroma | 43.88 | 12.51 | 12 | 25800 | 239 | 56266016 |
Gastroschisis | 42.75 | 12.51 | 12 | 25800 | 264 | 56265991 |
Back pain | 42.59 | 12.51 | 218 | 25594 | 236952 | 56029303 |
Small for dates baby | 42.34 | 12.51 | 24 | 25788 | 3506 | 56262749 |
Arthropathy | 41.45 | 12.51 | 20 | 25792 | 200255 | 56066000 |
Hormone level abnormal | 39.95 | 12.51 | 20 | 25792 | 2275 | 56263980 |
Pericarditis | 38.55 | 12.51 | 3 | 25809 | 108920 | 56157335 |
Intermenstrual bleeding | 37.96 | 12.51 | 29 | 25783 | 6998 | 56259257 |
Head discomfort | 37.11 | 12.51 | 36 | 25776 | 11978 | 56254277 |
Human herpesvirus 6 infection | 37.01 | 12.51 | 20 | 25792 | 2662 | 56263593 |
Photosensitivity reaction | 36.95 | 12.51 | 38 | 25774 | 13555 | 56252700 |
Foetal death | 36.92 | 12.51 | 31 | 25781 | 8556 | 56257699 |
Foetal growth restriction | 35.52 | 12.51 | 28 | 25784 | 7071 | 56259184 |
HELLP syndrome | 35.22 | 12.51 | 14 | 25798 | 922 | 56265333 |
Ascites | 34.70 | 12.51 | 62 | 25750 | 37482 | 56228773 |
Adnexal torsion | 34.60 | 12.51 | 11 | 25801 | 375 | 56265880 |
Single umbilical artery | 34.49 | 12.51 | 10 | 25802 | 248 | 56266007 |
Uterine haemorrhage | 34.39 | 12.51 | 21 | 25791 | 3519 | 56262736 |
Ventricular septal defect | 33.82 | 12.51 | 22 | 25790 | 4116 | 56262139 |
Breast hyperplasia | 33.68 | 12.51 | 10 | 25802 | 270 | 56265985 |
Tinnitus | 33.58 | 12.51 | 54 | 25758 | 29988 | 56236267 |
Completed suicide | 33.28 | 12.51 | 10 | 25802 | 133823 | 56132432 |
Hepatic enzyme increased | 33.19 | 12.51 | 161 | 25651 | 171223 | 56095032 |
Suicidal behaviour | 33.18 | 12.51 | 18 | 25794 | 2415 | 56263840 |
Product odour abnormal | 32.78 | 12.51 | 14 | 25798 | 1107 | 56265148 |
Ovarian haemorrhage | 31.97 | 12.51 | 10 | 25802 | 323 | 56265932 |
Ophthalmic vein thrombosis | 31.28 | 12.51 | 9 | 25803 | 217 | 56266038 |
Blood oestrogen decreased | 30.42 | 12.51 | 9 | 25803 | 240 | 56266015 |
Endometrial stromal sarcoma | 30.29 | 12.51 | 6 | 25806 | 25 | 56266230 |
Product quality issue | 30.09 | 12.51 | 53 | 25759 | 31683 | 56234572 |
Retroplacental haematoma | 29.86 | 12.51 | 8 | 25804 | 147 | 56266108 |
Retained placenta or membranes | 28.89 | 12.51 | 9 | 25803 | 287 | 56265968 |
Anxiety | 28.88 | 12.51 | 169 | 25643 | 193003 | 56073252 |
Caesarean section | 28.45 | 12.51 | 36 | 25776 | 16055 | 56250200 |
Neutropenia | 28.13 | 12.51 | 19 | 25793 | 158148 | 56108107 |
Vaginal discharge | 28.06 | 12.51 | 23 | 25789 | 6140 | 56260115 |
Abortion missed | 27.82 | 12.51 | 14 | 25798 | 1610 | 56264645 |
Ovarian cyst | 27.47 | 12.51 | 34 | 25778 | 14832 | 56251423 |
Blister | 27.31 | 12.51 | 8 | 25804 | 108879 | 56157376 |
Treatment failure | 27.06 | 12.51 | 23 | 25789 | 170369 | 56095886 |
Abdominal discomfort | 27.00 | 12.51 | 54 | 25758 | 277220 | 55989035 |
Periodic limb movement disorder | 26.98 | 12.51 | 8 | 25804 | 215 | 56266040 |
Hypersensitivity | 26.69 | 12.51 | 205 | 25607 | 256203 | 56010052 |
Twin pregnancy | 26.30 | 12.51 | 12 | 25800 | 1111 | 56265144 |
Sepsis | 25.96 | 12.51 | 16 | 25796 | 139824 | 56126431 |
Swelling | 25.73 | 12.51 | 44 | 25768 | 239727 | 56026528 |
Decreased appetite | 24.67 | 12.51 | 39 | 25773 | 219192 | 56047063 |
Pelvic infection | 24.62 | 12.51 | 8 | 25804 | 293 | 56265962 |
Preterm premature rupture of membranes | 24.52 | 12.51 | 12 | 25800 | 1300 | 56264955 |
Confusional state | 24.41 | 12.51 | 36 | 25776 | 208119 | 56058136 |
Therapeutic product effect decreased | 24.40 | 12.51 | 25 | 25787 | 169427 | 56096828 |
Hippocampal sclerosis | 24.26 | 12.51 | 6 | 25806 | 79 | 56266176 |
Cardiac arrest | 24.26 | 12.51 | 5 | 25807 | 86309 | 56179946 |
Breast tenderness | 24.17 | 12.51 | 14 | 25798 | 2131 | 56264124 |
Drug intolerance | 23.76 | 12.51 | 54 | 25758 | 264764 | 56001491 |
Talipes | 23.45 | 12.51 | 12 | 25800 | 1430 | 56264825 |
Application site pruritus | 23.40 | 12.51 | 17 | 25795 | 3802 | 56262453 |
Complication of pregnancy | 23.04 | 12.51 | 9 | 25803 | 566 | 56265689 |
Patent ductus arteriosus | 22.88 | 12.51 | 17 | 25795 | 3934 | 56262321 |
Product use in unapproved indication | 22.88 | 12.51 | 126 | 25686 | 140696 | 56125559 |
Application site erythema | 22.71 | 12.51 | 18 | 25794 | 4582 | 56261673 |
Anaemia | 22.06 | 12.51 | 57 | 25755 | 267454 | 55998801 |
Subchorionic haematoma | 21.78 | 12.51 | 6 | 25806 | 123 | 56266132 |
General physical health deterioration | 21.33 | 12.51 | 28 | 25784 | 169982 | 56096273 |
Menopausal symptoms | 21.32 | 12.51 | 13 | 25799 | 2172 | 56264083 |
Mediastinal effusion | 21.21 | 12.51 | 5 | 25807 | 53 | 56266202 |
Hydrops foetalis | 21.00 | 12.51 | 8 | 25804 | 470 | 56265785 |
Product use issue | 20.62 | 12.51 | 151 | 25661 | 185890 | 56080365 |
Carnitine deficiency | 20.50 | 12.51 | 6 | 25806 | 154 | 56266101 |
Congenital umbilical hernia | 20.36 | 12.51 | 7 | 25805 | 306 | 56265949 |
Lower respiratory tract infection | 20.13 | 12.51 | 14 | 25798 | 114780 | 56151475 |
Application site rash | 20.09 | 12.51 | 13 | 25799 | 2410 | 56263845 |
Eosinophilic pneumonia acute | 19.91 | 12.51 | 7 | 25805 | 327 | 56265928 |
Cholestasis of pregnancy | 19.70 | 12.51 | 10 | 25802 | 1171 | 56265084 |
Ultrasound liver abnormal | 19.59 | 12.51 | 4 | 25808 | 20 | 56266235 |
Tubo-ovarian abscess | 19.45 | 12.51 | 7 | 25805 | 350 | 56265905 |
Ovarian abscess | 19.18 | 12.51 | 6 | 25806 | 194 | 56266061 |
Temporal lobe epilepsy | 18.92 | 12.51 | 7 | 25805 | 379 | 56265876 |
Drug abuse | 18.83 | 12.51 | 4 | 25808 | 67606 | 56198649 |
Oestradiol increased | 18.81 | 12.51 | 5 | 25807 | 89 | 56266166 |
Abdominal pain lower | 18.66 | 12.51 | 36 | 25776 | 23056 | 56243199 |
Hypogonadism | 18.61 | 12.51 | 5 | 25807 | 93 | 56266162 |
Peripheral swelling | 18.60 | 12.51 | 51 | 25761 | 234675 | 56031580 |
Renal impairment | 18.37 | 12.51 | 7 | 25805 | 80706 | 56185549 |
Prescribed overdose | 18.31 | 12.51 | 35 | 25777 | 22261 | 56243994 |
Therapeutic response unexpected | 18.18 | 12.51 | 30 | 25782 | 17014 | 56249241 |
Feeling abnormal | 18.12 | 12.51 | 114 | 25698 | 133488 | 56132767 |
Postpartum haemorrhage | 18.04 | 12.51 | 11 | 25801 | 1838 | 56264417 |
Infection | 17.80 | 12.51 | 41 | 25771 | 200165 | 56066090 |
Cardiac failure congestive | 17.77 | 12.51 | 9 | 25803 | 87711 | 56178544 |
Uterine haematoma | 17.76 | 12.51 | 4 | 25808 | 34 | 56266221 |
Breast enlargement | 17.70 | 12.51 | 10 | 25802 | 1451 | 56264804 |
Malignant neoplasm progression | 17.40 | 12.51 | 6 | 25806 | 73581 | 56192674 |
Cardiac failure | 17.27 | 12.51 | 8 | 25804 | 82085 | 56184170 |
Endometrial hyperplasia | 17.16 | 12.51 | 8 | 25804 | 778 | 56265477 |
Feeling hot | 17.14 | 12.51 | 50 | 25762 | 41737 | 56224518 |
Turner's syndrome | 17.13 | 12.51 | 5 | 25807 | 127 | 56266128 |
Gastrointestinal haemorrhage | 16.61 | 12.51 | 7 | 25805 | 75944 | 56190311 |
Application site irritation | 16.56 | 12.51 | 10 | 25802 | 1642 | 56264613 |
Enlarged clitoris | 16.31 | 12.51 | 5 | 25807 | 151 | 56266104 |
Renal failure | 16.25 | 12.51 | 16 | 25796 | 110484 | 56155771 |
Joint swelling | 16.23 | 12.51 | 73 | 25739 | 289727 | 55976528 |
Biochemical pregnancy | 16.17 | 12.51 | 3 | 25809 | 8 | 56266247 |
Stomatitis | 16.09 | 12.51 | 19 | 25793 | 120791 | 56145464 |
Premature separation of placenta | 15.98 | 12.51 | 10 | 25802 | 1750 | 56264505 |
Injection site pain | 15.92 | 12.51 | 100 | 25712 | 117018 | 56149237 |
Haemoglobin decreased | 15.91 | 12.51 | 23 | 25789 | 134114 | 56132141 |
Palatal polyp | 15.91 | 12.51 | 3 | 25809 | 9 | 56266246 |
Primary hypogonadism | 15.88 | 12.51 | 5 | 25807 | 165 | 56266090 |
Folliculitis | 15.83 | 12.51 | 3 | 25809 | 54976 | 56211279 |
Incorrect dose administered | 15.34 | 12.51 | 56 | 25756 | 52491 | 56213764 |
Product taste abnormal | 15.34 | 12.51 | 10 | 25802 | 1878 | 56264377 |
Hypotension | 15.32 | 12.51 | 61 | 25751 | 250447 | 56015808 |
Live birth | 15.15 | 12.51 | 30 | 25782 | 19575 | 56246680 |
Swelling face | 14.92 | 12.51 | 58 | 25754 | 56011 | 56210244 |
Fallopian tube disorder | 14.83 | 12.51 | 6 | 25806 | 414 | 56265841 |
Retinal vein occlusion | 14.77 | 12.51 | 10 | 25802 | 1998 | 56264257 |
Wheezing | 14.75 | 12.51 | 8 | 25804 | 75018 | 56191237 |
Product physical issue | 14.66 | 12.51 | 14 | 25798 | 4568 | 56261687 |
Disease progression | 14.59 | 12.51 | 16 | 25796 | 105157 | 56161098 |
Arterial intramural haematoma | 14.53 | 12.51 | 3 | 25809 | 16 | 56266239 |
Idiopathic angioedema | 14.53 | 12.51 | 3 | 25809 | 16 | 56266239 |
Heterotopic pregnancy | 14.53 | 12.51 | 3 | 25809 | 16 | 56266239 |
Pulmonary oedema | 14.29 | 12.51 | 3 | 25809 | 51140 | 56215115 |
Endometrial cancer stage I | 14.25 | 12.51 | 5 | 25807 | 232 | 56266023 |
Dyspnoea | 14.24 | 12.51 | 189 | 25623 | 592388 | 55673867 |
Keratoconus | 14.23 | 12.51 | 3 | 25809 | 18 | 56266237 |
Blood oestrogen increased | 14.21 | 12.51 | 4 | 25808 | 89 | 56266166 |
Nerve compression | 14.05 | 12.51 | 18 | 25794 | 8126 | 56258129 |
Infusion related reaction | 13.99 | 12.51 | 49 | 25763 | 208882 | 56057373 |
Foetal hypokinesia | 13.98 | 12.51 | 6 | 25806 | 480 | 56265775 |
Irritable bowel syndrome | 13.90 | 12.51 | 7 | 25805 | 68451 | 56197804 |
Drug exposure before pregnancy | 13.88 | 12.51 | 7 | 25805 | 809 | 56265446 |
Foreign body in reproductive tract | 13.80 | 12.51 | 6 | 25806 | 496 | 56265759 |
Anti-Muellerian hormone level decreased | 13.77 | 12.51 | 4 | 25808 | 100 | 56266155 |
Application site urticaria | 13.76 | 12.51 | 5 | 25807 | 257 | 56265998 |
Chorioretinopathy | 13.73 | 12.51 | 7 | 25805 | 827 | 56265428 |
Abortion | 13.67 | 12.51 | 10 | 25802 | 2259 | 56263996 |
Febrile neutropenia | 13.63 | 12.51 | 17 | 25795 | 105528 | 56160727 |
Erythema nodosum | 13.58 | 12.51 | 13 | 25799 | 4252 | 56262003 |
Liver tenderness | 13.58 | 12.51 | 4 | 25808 | 105 | 56266150 |
Impaired healing | 13.44 | 12.51 | 12 | 25800 | 86829 | 56179426 |
Vomiting | 13.43 | 12.51 | 155 | 25657 | 498073 | 55768182 |
Product substitution issue | 13.34 | 12.51 | 24 | 25788 | 14575 | 56251680 |
Embedded device | 13.27 | 12.51 | 11 | 25801 | 2982 | 56263273 |
Placental insufficiency | 13.11 | 12.51 | 8 | 25804 | 1338 | 56264917 |
Chronic obstructive pulmonary disease | 13.03 | 12.51 | 5 | 25807 | 57410 | 56208845 |
Abdominal distension | 12.96 | 12.51 | 70 | 25742 | 77556 | 56188699 |
Muscle injury | 12.90 | 12.51 | 4 | 25808 | 52496 | 56213759 |
Platelet count decreased | 12.85 | 12.51 | 18 | 25794 | 106365 | 56159890 |
Meningioma benign | 12.75 | 12.51 | 5 | 25807 | 318 | 56265937 |
Cervical incompetence | 12.73 | 12.51 | 6 | 25806 | 598 | 56265657 |
Low birth weight baby | 12.68 | 12.51 | 15 | 25797 | 6243 | 56260012 |
Birth mark | 12.65 | 12.51 | 4 | 25808 | 134 | 56266121 |
Eosinophilic pneumonia | 12.57 | 12.51 | 9 | 25803 | 1968 | 56264287 |
MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
---|---|---|---|---|---|---|
Foetal exposure during pregnancy | 753.46 | 111.45 | 185 | 813 | 40691 | 31655655 |
Premature baby | 324.55 | 111.45 | 81 | 917 | 17985 | 31678361 |
Atrial septal defect | 138.47 | 111.45 | 34 | 964 | 6893 | 31689453 |
MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
---|---|---|---|---|---|---|
Ovarian hyperstimulation syndrome | 903.12 | 14.36 | 203 | 19095 | 3037 | 70906109 |
Temperature regulation disorder | 479.73 | 14.36 | 130 | 19168 | 4314 | 70904832 |
Food allergy | 404.25 | 14.36 | 132 | 19166 | 8392 | 70900754 |
Coeliac disease | 396.73 | 14.36 | 132 | 19166 | 8901 | 70900245 |
Immunodeficiency | 317.99 | 14.36 | 134 | 19164 | 17421 | 70891725 |
Bursitis | 276.15 | 14.36 | 138 | 19160 | 26535 | 70882611 |
Exposure during pregnancy | 271.45 | 14.36 | 210 | 19088 | 87507 | 70821639 |
Maternal exposure during pregnancy | 260.53 | 14.36 | 230 | 19068 | 115115 | 70794031 |
Rash erythematous | 200.76 | 14.36 | 142 | 19156 | 51576 | 70857570 |
Fluid retention | 187.84 | 14.36 | 148 | 19150 | 63237 | 70845909 |
Premature delivery | 173.89 | 14.36 | 94 | 19204 | 21210 | 70887936 |
Abortion spontaneous | 160.02 | 14.36 | 96 | 19202 | 26383 | 70882763 |
Upper respiratory tract infection | 149.45 | 14.36 | 143 | 19155 | 79131 | 70830015 |
Premature labour | 134.65 | 14.36 | 58 | 19240 | 7942 | 70901204 |
Hyperhidrosis | 132.67 | 14.36 | 171 | 19127 | 131415 | 70777731 |
Gestational diabetes | 122.78 | 14.36 | 50 | 19248 | 5951 | 70903195 |
Headache | 119.19 | 14.36 | 387 | 18911 | 580018 | 70329128 |
Asthma | 107.92 | 14.36 | 148 | 19150 | 120645 | 70788501 |
Meningioma | 105.12 | 14.36 | 40 | 19258 | 3978 | 70905168 |
Butterfly rash | 96.44 | 14.36 | 29 | 19269 | 1401 | 70907745 |
Erythema | 92.86 | 14.36 | 182 | 19116 | 199381 | 70709765 |
Autoimmune dermatitis | 87.12 | 14.36 | 15 | 19283 | 46 | 70909100 |
Death | 86.47 | 14.36 | 17 | 19281 | 510044 | 70399102 |
Haemorrhage in pregnancy | 85.50 | 14.36 | 26 | 19272 | 1305 | 70907841 |
Hepatic enzyme increased | 85.25 | 14.36 | 153 | 19145 | 156837 | 70752309 |
Vaginal haemorrhage | 83.85 | 14.36 | 58 | 19240 | 20294 | 70888852 |
Pre-eclampsia | 83.53 | 14.36 | 39 | 19259 | 6446 | 70902700 |
Premature rupture of membranes | 78.11 | 14.36 | 32 | 19266 | 3866 | 70905280 |
Drug hypersensitivity | 76.78 | 14.36 | 199 | 19099 | 262260 | 70646886 |
Normal newborn | 75.35 | 14.36 | 36 | 19262 | 6264 | 70902882 |
Placenta accreta | 74.22 | 14.36 | 16 | 19282 | 194 | 70908952 |
Acute kidney injury | 74.04 | 14.36 | 19 | 19279 | 474605 | 70434541 |
Back pain | 72.65 | 14.36 | 199 | 19099 | 270953 | 70638193 |
Product adhesion issue | 69.19 | 14.36 | 26 | 19272 | 2498 | 70906648 |
Toxicity to various agents | 68.50 | 14.36 | 11 | 19287 | 382161 | 70526985 |
Maternal exposure before pregnancy | 65.31 | 14.36 | 28 | 19270 | 3788 | 70905358 |
Constipation | 62.43 | 14.36 | 180 | 19118 | 252258 | 70656888 |
Hypersensitivity | 60.86 | 14.36 | 168 | 19130 | 229644 | 70679502 |
Ovarian enlargement | 55.54 | 14.36 | 14 | 19284 | 347 | 70908799 |
Abortion threatened | 53.50 | 14.36 | 14 | 19284 | 404 | 70908742 |
Periorbital oedema | 49.06 | 14.36 | 29 | 19269 | 7746 | 70901400 |
Head discomfort | 48.73 | 14.36 | 35 | 19263 | 12988 | 70896158 |
HELLP syndrome | 46.09 | 14.36 | 14 | 19284 | 700 | 70908446 |
Ectopic pregnancy | 45.66 | 14.36 | 17 | 19281 | 1591 | 70907555 |
Progesterone decreased | 44.62 | 14.36 | 8 | 19290 | 33 | 70909113 |
Hot flush | 44.59 | 14.36 | 61 | 19237 | 49523 | 70859623 |
Vulvovaginal discomfort | 41.58 | 14.36 | 16 | 19282 | 1639 | 70907507 |
Breast hyperplasia | 40.55 | 14.36 | 9 | 19289 | 126 | 70909020 |
Off label use | 40.47 | 14.36 | 342 | 18956 | 742718 | 70166428 |
Photosensitivity reaction | 40.45 | 14.36 | 37 | 19261 | 19303 | 70889843 |
Uterine haemorrhage | 40.42 | 14.36 | 18 | 19280 | 2666 | 70906480 |
Pregnancy | 39.37 | 14.36 | 40 | 19258 | 23741 | 70885405 |
Rheumatoid arthritis | 39.04 | 14.36 | 170 | 19128 | 291635 | 70617511 |
Pneumonia | 38.95 | 14.36 | 64 | 19234 | 596168 | 70312978 |
Ovarian haemorrhage | 37.71 | 14.36 | 10 | 19288 | 304 | 70908842 |
Ophthalmic vein thrombosis | 35.40 | 14.36 | 9 | 19289 | 231 | 70908915 |
Neutropenia | 35.17 | 14.36 | 13 | 19285 | 257143 | 70652003 |
Suicidal behaviour | 35.14 | 14.36 | 17 | 19281 | 3039 | 70906107 |
Fatigue | 35.12 | 14.36 | 360 | 18938 | 823959 | 70085187 |
Tinnitus | 34.81 | 14.36 | 46 | 19252 | 36130 | 70873016 |
Completed suicide | 33.66 | 14.36 | 10 | 19288 | 227125 | 70682021 |
Pain | 33.43 | 14.36 | 288 | 19010 | 628528 | 70280618 |
Adnexal torsion | 32.89 | 14.36 | 9 | 19289 | 309 | 70908837 |
Postmenopausal haemorrhage | 32.76 | 14.36 | 13 | 19285 | 1446 | 70907700 |
Cardiac arrest | 32.51 | 14.36 | 3 | 19295 | 159831 | 70749315 |
Twin pregnancy | 31.71 | 14.36 | 11 | 19287 | 840 | 70908306 |
Foetal death | 31.04 | 14.36 | 20 | 19278 | 6219 | 70902927 |
Retroplacental haematoma | 30.49 | 14.36 | 7 | 19291 | 115 | 70909031 |
Contraindicated product administered | 30.37 | 14.36 | 93 | 19205 | 134519 | 70774627 |
Hormone level abnormal | 30.19 | 14.36 | 13 | 19285 | 1777 | 70907369 |
Caesarean section | 29.89 | 14.36 | 25 | 19273 | 11582 | 70897564 |
Ascites | 29.41 | 14.36 | 60 | 19238 | 67487 | 70841659 |
Drug abuse | 29.33 | 14.36 | 3 | 19295 | 147253 | 70761893 |
Intermenstrual bleeding | 29.04 | 14.36 | 18 | 19280 | 5232 | 70903914 |
Oligohydramnios | 28.40 | 14.36 | 15 | 19283 | 3225 | 70905921 |
Pelvic infection | 28.25 | 14.36 | 8 | 19290 | 312 | 70908834 |
Endometrial stromal sarcoma | 28.01 | 14.36 | 5 | 19293 | 20 | 70909126 |
Foetal exposure during pregnancy | 27.85 | 14.36 | 18 | 19280 | 5627 | 70903519 |
Product odour abnormal | 27.75 | 14.36 | 11 | 19287 | 1220 | 70907926 |
Menopausal symptoms | 27.44 | 14.36 | 12 | 19286 | 1702 | 70907444 |
Ovarian abscess | 27.24 | 14.36 | 6 | 19292 | 81 | 70909065 |
Sepsis | 26.40 | 14.36 | 17 | 19281 | 244528 | 70664618 |
Oestradiol increased | 26.35 | 14.36 | 6 | 19292 | 95 | 70909051 |
Foetal growth restriction | 26.14 | 14.36 | 12 | 19286 | 1907 | 70907239 |
Retained placenta or membranes | 26.12 | 14.36 | 7 | 19291 | 222 | 70908924 |
Ovarian cyst | 25.56 | 14.36 | 23 | 19275 | 11749 | 70897397 |
Prescribed overdose | 25.28 | 14.36 | 34 | 19264 | 27147 | 70881999 |
Swelling face | 25.05 | 14.36 | 54 | 19244 | 63110 | 70846036 |
Synovitis | 24.80 | 14.36 | 3 | 19295 | 129225 | 70779921 |
Anaemia | 24.75 | 14.36 | 45 | 19253 | 403378 | 70505768 |
Preterm premature rupture of membranes | 24.46 | 14.36 | 10 | 19288 | 1201 | 70907945 |
Abdominal pain lower | 24.29 | 14.36 | 34 | 19264 | 28182 | 70880964 |
Mediastinal effusion | 23.64 | 14.36 | 5 | 19293 | 55 | 70909091 |
Tubo-ovarian abscess | 23.61 | 14.36 | 7 | 19291 | 322 | 70908824 |
Decreased appetite | 23.53 | 14.36 | 29 | 19269 | 304751 | 70604395 |
Renal failure | 23.52 | 14.36 | 11 | 19287 | 189059 | 70720087 |
Product use issue | 23.40 | 14.36 | 104 | 19194 | 179833 | 70729313 |
Complication of pregnancy | 23.26 | 14.36 | 7 | 19291 | 339 | 70908807 |
Hypotension | 23.15 | 14.36 | 47 | 19251 | 404334 | 70504812 |
Confusional state | 23.09 | 14.36 | 26 | 19272 | 284372 | 70624774 |
Cholestasis of pregnancy | 23.04 | 14.36 | 9 | 19289 | 960 | 70908186 |
Postpartum haemorrhage | 22.33 | 14.36 | 10 | 19288 | 1501 | 70907645 |
Feeling hot | 22.10 | 14.36 | 44 | 19254 | 48626 | 70860520 |
Hirsutism | 22.06 | 14.36 | 9 | 19289 | 1075 | 70908071 |
Hypotonia neonatal | 22.02 | 14.36 | 5 | 19293 | 78 | 70909068 |
Renal impairment | 21.94 | 14.36 | 6 | 19292 | 143931 | 70765215 |
Injection site pain | 21.79 | 14.36 | 76 | 19222 | 117543 | 70791603 |
Porphyria non-acute | 21.62 | 14.36 | 8 | 19290 | 736 | 70908410 |
Febrile neutropenia | 20.98 | 14.36 | 15 | 19283 | 204303 | 70704843 |
Uterine haematoma | 20.79 | 14.36 | 4 | 19294 | 26 | 70909120 |
Carnitine deficiency | 20.54 | 14.36 | 6 | 19292 | 262 | 70908884 |
Gastrointestinal haemorrhage | 20.43 | 14.36 | 6 | 19292 | 137402 | 70771744 |
Cardiac failure | 20.05 | 14.36 | 7 | 19291 | 143534 | 70765612 |
Anxiety | 19.95 | 14.36 | 115 | 19183 | 220215 | 70688931 |
Breast enlargement | 19.94 | 14.36 | 9 | 19289 | 1375 | 70907771 |
Nephrocalcinosis | 19.84 | 14.36 | 9 | 19289 | 1392 | 70907754 |
Blood oestrogen decreased | 19.50 | 14.36 | 5 | 19293 | 133 | 70909013 |
Bradycardia | 19.36 | 14.36 | 5 | 19293 | 124610 | 70784536 |
Vaginal discharge | 18.83 | 14.36 | 13 | 19285 | 4530 | 70904616 |
Placental insufficiency | 18.79 | 14.36 | 8 | 19290 | 1063 | 70908083 |
Fallopian tube disorder | 18.52 | 14.36 | 6 | 19292 | 371 | 70908775 |
Primary hypogonadism | 18.26 | 14.36 | 5 | 19293 | 172 | 70908974 |
Abortion missed | 17.91 | 14.36 | 8 | 19290 | 1193 | 70907953 |
Congenital hydronephrosis | 17.47 | 14.36 | 3 | 19295 | 9 | 70909137 |
Live birth | 17.24 | 14.36 | 20 | 19278 | 13759 | 70895387 |
Ovarian cyst ruptured | 16.92 | 14.36 | 7 | 19291 | 867 | 70908279 |
Malignant neoplasm progression | 16.89 | 14.36 | 6 | 19292 | 121733 | 70787413 |
Hydrops foetalis | 16.70 | 14.36 | 5 | 19293 | 238 | 70908908 |
Erythema nodosum | 16.66 | 14.36 | 12 | 19286 | 4469 | 70904677 |
Cardiac failure congestive | 16.66 | 14.36 | 8 | 19290 | 135449 | 70773697 |
Eosinophilic pneumonia acute | 16.53 | 14.36 | 7 | 19291 | 918 | 70908228 |
Product taste abnormal | 16.24 | 14.36 | 9 | 19289 | 2127 | 70907019 |
Embedded device | 16.22 | 14.36 | 10 | 19288 | 2879 | 70906267 |
Heterotopic pregnancy | 16.10 | 14.36 | 3 | 19295 | 16 | 70909130 |
Systemic lupus erythematosus | 16.00 | 14.36 | 4 | 19294 | 101898 | 70807248 |
Genital haemorrhage | 15.97 | 14.36 | 13 | 19285 | 5802 | 70903344 |
Failed induction of labour | 15.91 | 14.36 | 5 | 19293 | 280 | 70908866 |
Nerve compression | 15.85 | 14.36 | 15 | 19283 | 8163 | 70900983 |
Anti-Muellerian hormone level decreased | 15.83 | 14.36 | 4 | 19294 | 100 | 70909046 |
Depressed mood | 15.72 | 14.36 | 36 | 19262 | 43784 | 70865362 |
Cardio-respiratory arrest | 15.71 | 14.36 | 4 | 19294 | 100673 | 70808473 |
General physical health deterioration | 15.67 | 14.36 | 25 | 19273 | 236006 | 70673140 |
Retinal vein occlusion | 15.53 | 14.36 | 10 | 19288 | 3106 | 70906040 |
Subchorionic haematoma | 15.50 | 14.36 | 4 | 19294 | 109 | 70909037 |
Haemoglobin decreased | 15.33 | 14.36 | 20 | 19278 | 205139 | 70704007 |
Drug interaction | 15.23 | 14.36 | 53 | 19245 | 381388 | 70527758 |
Idiopathic angioedema | 14.83 | 14.36 | 3 | 19295 | 26 | 70909120 |
Platelet count decreased | 14.78 | 14.36 | 16 | 19282 | 178206 | 70730940 |
MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
---|---|---|---|---|---|---|
Human herpesvirus 6 infection | 46.81 | 37.71 | 15 | 363 | 45 | 89369 |
Congestive cardiomyopathy | 40.41 | 37.71 | 14 | 364 | 57 | 89357 |
Source | Code | Description |
---|---|---|
ATC | G03DA04 | GENITO URINARY SYSTEM AND SEX HORMONES SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM PROGESTOGENS Pregnen (4) derivatives |
ATC | G03FA04 | GENITO URINARY SYSTEM AND SEX HORMONES SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM PROGESTOGENS AND ESTROGENS IN COMBINATION Progestogens and estrogens, fixed combinations |
FDA CS | M0017672 | Progesterone |
FDA EPC | N0000175601 | Progesterone |
MeSH PA | D009465 | Neuromuscular Agents |
MeSH PA | D009466 | Neuromuscular Blocking Agents |
MeSH PA | D003473 | Neuromuscular Nondepolarizing Agents |
MeSH PA | D018373 | Peripheral Nervous System Agents |
MeSH PA | D006728 | Hormones |
MeSH PA | D011372 | Progestins |
CHEBI has role | CHEBI:49323 | contraceptive drugs |
CHEBI has role | CHEBI:59826 | progestins |
CHEBI has role | CHEBI:70709 | progesterone receptor agonists |
CHEBI has role | CHEBI:75771 | Mus musculus metabolites |
CHEBI has role | CHEBI:77746 | Homo sapiens metabolite |
Disease | Relation | SNOMED_ID | DOID |
---|---|---|---|
Contraception | indication | 13197004 | |
Dysfunctional uterine bleeding | indication | 19155002 | |
Atrophic vaginitis | indication | 52441000 | |
Secondary physiologic amenorrhea | indication | 86030004 | |
Secondary malignant neoplasm of kidney | indication | 94360002 | |
Postmenopausal osteoporosis | indication | 102447009 | |
Endometriosis | indication | 129103003 | |
Menopausal flushing | indication | 198436008 | |
Endometrial carcinoma | indication | 254878006 | DOID:2871 |
Infertility Secondary to Progesterone Deficiency | indication | ||
Amenorrhea Secondary to Ovarian Dysfunction | indication | ||
Endometrial Hyperplasia Prevention | indication | ||
Prevention of Premature Labor | indication | ||
Corpus Luteum Insufficiency Syndrome | indication | ||
Polycystic ovaries | off-label use | 69878008 | |
Menorrhagia | off-label use | 386692008 | |
Precocious puberty | off-label use | 400179000 | |
Female Hormonal Imbalance | off-label use | ||
Endogenous Estrogen Production Test | off-label use | ||
Hyperlipoproteinemia | contraindication | 3744001 | DOID:1168 |
Hypocalcemia | contraindication | 5291005 | |
Alcoholism | contraindication | 7200002 | |
Weight gain finding | contraindication | 8943002 | |
Impaired glucose tolerance | contraindication | 9414007 | |
Hypercholesterolemia | contraindication | 13644009 | |
Jaundice | contraindication | 18165001 | |
Myocardial infarction | contraindication | 22298006 | DOID:5844 |
Fibroadenosis of breast | contraindication | 23260002 | DOID:10352 |
Diplopia | contraindication | 24982008 | |
Retinal hemorrhage | contraindication | 28998008 | |
Ectopic pregnancy | contraindication | 34801009 | DOID:0060329 |
Depressive disorder | contraindication | 35489007 | |
Chloasma | contraindication | 36209000 | |
Migraine | contraindication | 37796009 | DOID:6364 |
Hypertensive disorder | contraindication | 38341003 | DOID:10763 |
Disorder of gallbladder | contraindication | 39621005 | DOID:0060262 |
Hypothyroidism | contraindication | 40930008 | DOID:1459 |
Mild pre-eclampsia | contraindication | 41114007 | |
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 |
Anorexia nervosa | contraindication | 56882008 | DOID:8689 |
Hepatic failure | contraindication | 59927004 | |
Cerebrovascular disease | contraindication | 62914000 | DOID:6713 |
Thrombophlebitis | contraindication | 64156001 | DOID:3875 |
Osteoporosis | contraindication | 64859006 | DOID:11476 |
Intermenstrual bleeding - irregular | contraindication | 64996003 | |
Diabetes mellitus | contraindication | 73211009 | DOID:9351 |
Hyperglycemia | contraindication | 80394007 | DOID:4195 |
Epilepsy | contraindication | 84757009 | DOID:1826 |
Breast lump | contraindication | 89164003 | |
Kidney disease | contraindication | 90708001 | DOID:557 |
Malignant neoplasm of liver | contraindication | 93870000 | DOID:3571 |
Uterine leiomyoma | contraindication | 95315005 | DOID:13223 |
Neoplasm of liver | contraindication | 126851005 | DOID:3571 |
Deep venous thrombosis | contraindication | 128053003 | |
Seizure disorder | contraindication | 128613002 | |
Incomplete miscarriage | contraindication | 156072005 | |
Bed-ridden | contraindication | 160685001 | |
Mammography abnormal | contraindication | 168750009 | |
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 |
Chorea | contraindication | 271700006 | |
Pregnancy, function | contraindication | 289908002 | |
Hypertriglyceridemia | contraindication | 302870006 | |
Osteopenia | contraindication | 312894000 | |
Functional visual loss | contraindication | 313165001 | |
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 | |
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 | |
Predisposition to Thrombosis | contraindication |
Species | Use | Relation |
---|---|---|
Cattle | Estrus synchronization | Indication |
Cattle | Induction of estrous cycles | Indication |
Cattle | Synchronization of the return to estrus | Indication |
Cattle | Advancement of first postpartum estrus | Indication |
Cattle | Advancement of first pubertal estrus | Indication |
Cattle | To increase rate of weight gain | Indication |
Cattle | To improve feed efficiency | Indication |
Sheep | Estrus induction | Indication |
Product | Applicant | Ingredients |
---|---|---|
Synovex C, Synovex S | Zoetis Inc. | 2 |
Component E-C with Tylan, Component E-S with Tylan | Elanco US Inc. | 3 |
EAZI-BREED CIDR Cattle Insert | Zoetis Inc. | 1 |
EAZI-BREED CIDR Sheep Insert | Zoetis Inc. | 1 |
None
Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Patent number | Patent expiration date | Patent use |
---|---|---|---|---|---|---|---|---|---|---|
1.78GM | MILPROSA | FERRING PHARMS INC | N201110 | April 29, 2020 | DISCN | SYSTEM | VAGINAL | 10548904 | Feb. 3, 2029 | METHOD OF SUPPORTING EMBRYO IMPLANTATION AND EARLY PREGNANCY BY SUPPLEMENTATION OF CORPUS LUTEAL FUNCTION AS PART OF AN ASSISTED REPRODUCTIVE TECHNOLOGY (ART) TREATMENT PROGRAM FOR INFERTILE WOMEN |
1.78GM | MILPROSA | FERRING PHARMS INC | N201110 | April 29, 2020 | DISCN | SYSTEM | VAGINAL | 8580293 | Jan. 21, 2030 | METHOD OF SUPPORTING EMBRYO IMPLANTATION AND EARLY PREGNANCY BY SUPPLEMENTATION OF CORPUS LUTEAL FUNCTION AS PART OF AN ASSISTED REPRODUCTIVE TECHNOLOGY (ART) TREATMENT PROGRAM FOR INFERTILE WOMEN |
0.5MG;100MG | BIJUVA | THERAPEUTICSMD INC | N210132 | Dec. 28, 2021 | DISCN | CAPSULE | ORAL | 10206932 | Nov. 21, 2032 | TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS |
0.5MG;100MG | BIJUVA | THERAPEUTICSMD INC | N210132 | Dec. 28, 2021 | DISCN | CAPSULE | ORAL | 10675288 | Nov. 21, 2032 | TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS |
0.5MG;100MG | BIJUVA | THERAPEUTICSMD INC | N210132 | Dec. 28, 2021 | DISCN | CAPSULE | ORAL | 11033626 | Nov. 21, 2032 | TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS |
0.5MG;100MG | BIJUVA | THERAPEUTICSMD INC | N210132 | Dec. 28, 2021 | DISCN | CAPSULE | ORAL | 8846648 | Nov. 21, 2032 | TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS |
0.5MG;100MG | BIJUVA | THERAPEUTICSMD INC | N210132 | Dec. 28, 2021 | DISCN | CAPSULE | ORAL | 8846649 | Nov. 21, 2032 | TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS |
0.5MG;100MG | BIJUVA | THERAPEUTICSMD INC | N210132 | Dec. 28, 2021 | DISCN | CAPSULE | ORAL | 8933059 | Nov. 21, 2032 | TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS |
0.5MG;100MG | BIJUVA | THERAPEUTICSMD INC | N210132 | Dec. 28, 2021 | DISCN | CAPSULE | ORAL | 9114145 | Nov. 21, 2032 | TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS |
0.5MG;100MG | BIJUVA | THERAPEUTICSMD INC | N210132 | Dec. 28, 2021 | DISCN | CAPSULE | ORAL | 9114146 | Nov. 21, 2032 | TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS |
0.5MG;100MG | BIJUVA | THERAPEUTICSMD INC | N210132 | Dec. 28, 2021 | DISCN | CAPSULE | ORAL | 9301920 | Nov. 21, 2032 | TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS |
1MG;100MG | BIJUVA | THERAPEUTICSMD INC | N210132 | Oct. 28, 2018 | RX | CAPSULE | ORAL | 10206932 | Nov. 21, 2032 | TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS |
1MG;100MG | BIJUVA | THERAPEUTICSMD INC | N210132 | Oct. 28, 2018 | RX | CAPSULE | ORAL | 10675288 | Nov. 21, 2032 | TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS |
1MG;100MG | BIJUVA | THERAPEUTICSMD INC | N210132 | Oct. 28, 2018 | RX | CAPSULE | ORAL | 10806740 | Nov. 21, 2032 | TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS |
1MG;100MG | BIJUVA | THERAPEUTICSMD INC | N210132 | Oct. 28, 2018 | RX | CAPSULE | ORAL | 11033626 | Nov. 21, 2032 | TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS |
1MG;100MG | BIJUVA | THERAPEUTICSMD INC | N210132 | Oct. 28, 2018 | RX | CAPSULE | ORAL | 11103513 | Nov. 21, 2032 | TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS |
1MG;100MG | BIJUVA | THERAPEUTICSMD INC | N210132 | Oct. 28, 2018 | RX | CAPSULE | ORAL | 8846648 | Nov. 21, 2032 | TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS |
1MG;100MG | BIJUVA | THERAPEUTICSMD INC | N210132 | Oct. 28, 2018 | RX | CAPSULE | ORAL | 8846649 | Nov. 21, 2032 | TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS |
1MG;100MG | BIJUVA | THERAPEUTICSMD INC | N210132 | Oct. 28, 2018 | RX | CAPSULE | ORAL | 9006222 | Nov. 21, 2032 | TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS |
1MG;100MG | BIJUVA | THERAPEUTICSMD INC | N210132 | Oct. 28, 2018 | RX | CAPSULE | ORAL | 9114145 | Nov. 21, 2032 | TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS |
1MG;100MG | BIJUVA | THERAPEUTICSMD INC | N210132 | Oct. 28, 2018 | RX | CAPSULE | ORAL | 9114146 | Nov. 21, 2032 | TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS |
1MG;100MG | BIJUVA | THERAPEUTICSMD INC | N210132 | Oct. 28, 2018 | RX | CAPSULE | ORAL | 9301920 | Nov. 21, 2032 | TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS |
Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
---|---|---|---|---|---|---|---|---|---|
1.78GM | MILPROSA | FERRING PHARMS INC | N201110 | April 29, 2020 | DISCN | SYSTEM | VAGINAL | April 29, 2023 | NEW PRODUCT |
Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
---|---|---|---|---|---|---|---|---|---|
Progesterone receptor | Nuclear hormone receptor | AGONIST | ED50 | 9.88 | WOMBAT-PK | CHEMBL | |||
Sigma non-opioid intracellular receptor 1 | Membrane receptor | Ki | 6.59 | CHEMBL | |||||
Multidrug resistance protein 1 | Transporter | IC50 | 4.32 | CHEMBL | |||||
Glucocorticoid receptor | Nuclear hormone receptor | Ki | 7.52 | CHEMBL | |||||
Mineralocorticoid receptor | Nuclear hormone receptor | EC50 | 11 | WOMBAT-PK | |||||
Estrogen receptor | Nuclear hormone receptor | WOMBAT-PK | |||||||
Androgen receptor | Nuclear hormone receptor | Ki | 8.07 | CHEMBL | |||||
Corticosteroid-binding globulin | Secreted | Ki | 7.38 | CHEMBL | |||||
Sex hormone-binding globulin | Secreted | Kd | 6.94 | CHEMBL | |||||
Sterol O-acyltransferase 1 | Enzyme | IC50 | 4.77 | CHEMBL | |||||
Fatty acid-binding protein, intestinal | Cytosolic other | Ki | 4.70 | CHEMBL | |||||
Cation channel sperm-associated protein 1 | Ion channel | ACTIVATOR | EC50 | 8.11 | IUPHAR | ||||
Cation channel sperm-associated protein 2 | Ion channel | ACTIVATOR | EC50 | 8.11 | IUPHAR | ||||
Cation channel sperm-associated protein 3 | Ion channel | ACTIVATOR | EC50 | 8.11 | IUPHAR | ||||
Cation channel sperm-associated protein 4 | Ion channel | ACTIVATOR | EC50 | 8.11 | IUPHAR | ||||
Short transient receptor potential channel 5 | Ion channel | BLOCKER | IC50 | 5.30 | IUPHAR | ||||
Sodium/nucleoside cotransporter 1 | Transporter | Ki | 5.17 | DRUG MATRIX | |||||
P2X purinoceptor 3 | Ion channel | IC50 | 5.80 | CHEMBL | |||||
Androgen receptor | Transcription factor | IC50 | 5.81 | CHEMBL | |||||
Fatty acid-binding protein, liver | Unclassified | Ki | 7.57 | CHEMBL | |||||
Progesterone receptor | Transcription factor | Ki | 8.44 | DRUG MATRIX | |||||
Sigma non-opioid intracellular receptor 1 | Membrane receptor | Kd | 6.62 | CHEMBL | |||||
Androgen receptor | Transcription factor | IC50 | 7.43 | CHEMBL | |||||
Progesterone receptor | Transcription factor | Ki | 7.98 | CHEMBL | |||||
C-8 sterol isomerase | Enzyme | Ki | 5.35 | CHEMBL | |||||
Sigma non-opioid intracellular receptor 1 | Membrane other | Ki | 6.18 | CHEMBL | |||||
Steroid 5-alpha-reductase | Enzyme | IC50 | 5.80 | CHEMBL | |||||
Estrogen receptor | Transcription factor | Kd | 8.41 | CHEMBL |
ID | Source |
---|---|
4017453 | VUID |
N0000145841 | NUI |
D00066 | KEGG_DRUG |
4017453 | VANDF |
C0033308 | UMLSCUI |
CHEBI:17026 | CHEBI |
STR | PDB_CHEM_ID |
CHEMBL103 | ChEMBL_ID |
DB00396 | DRUGBANK_ID |
D011374 | MESH_DESCRIPTOR_UI |
C003549 | MESH_SUPPLEMENTAL_RECORD_UI |
5994 | PUBCHEM_CID |
2377 | IUPHAR_LIGAND_ID |
417 | INN_ID |
4G7DS2Q64Y | UNII |
8727 | RXNORM |
2110 | MMSL |
53089 | MMSL |
5365 | MMSL |
d00550 | MMSL |
001290 | NDDF |
16683002 | SNOMEDCT_US |
50318003 | SNOMEDCT_US |
Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
---|---|---|---|---|---|---|---|---|
Crinone | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0023-6150 | GEL | 45 mg | VAGINAL | NDA | 23 sections |
Crinone | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0023-6151 | GEL | 90 mg | VAGINAL | NDA | 23 sections |
Progesterone | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0143-9725 | INJECTION | 50 mg | INTRAMUSCULAR | ANDA | 13 sections |
PROGESTERONE | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0591-3128 | INJECTION, SOLUTION | 50 mg | INTRAMUSCULAR | NDA | 13 sections |
PROGESTERONE | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0591-3128 | INJECTION, SOLUTION | 50 mg | INTRAMUSCULAR | NDA | 13 sections |
PROGESTERONE | Human Prescription Drug Label | 1 | 10888-7135 | CAPSULE | 100 mg | ORAL | ANDA | 21 sections |
PROGESTERONE | Human Prescription Drug Label | 1 | 10888-7136 | CAPSULE | 200 mg | ORAL | ANDA | 21 sections |
Progesterone | HUMAN PRESCRIPTION DRUG LABEL | 1 | 16714-157 | CAPSULE | 100 mg | ORAL | ANDA | 25 sections |
Progesterone | HUMAN PRESCRIPTION DRUG LABEL | 1 | 16714-158 | CAPSULE | 200 mg | ORAL | ANDA | 25 sections |
Progesterone | HUMAN PRESCRIPTION DRUG LABEL | 1 | 17478-766 | CAPSULE | 100 mg | ORAL | ANDA | 23 sections |
Progesterone | HUMAN PRESCRIPTION DRUG LABEL | 1 | 17478-767 | CAPSULE | 200 mg | ORAL | ANDA | 23 sections |
Progesterone | HUMAN PRESCRIPTION DRUG LABEL | 1 | 43598-349 | CAPSULE | 100 mg | ORAL | ANDA | 21 sections |
Progesterone | HUMAN PRESCRIPTION DRUG LABEL | 1 | 43598-350 | CAPSULE | 200 mg | ORAL | ANDA | 21 sections |
Progesterone | HUMAN PRESCRIPTION DRUG LABEL | 1 | 50090-2527 | CAPSULE | 100 mg | ORAL | ANDA | 23 sections |
Progesterone | HUMAN PRESCRIPTION DRUG LABEL | 1 | 50090-3240 | CAPSULE | 100 mg | ORAL | NDA | 24 sections |
Progesterone | HUMAN PRESCRIPTION DRUG LABEL | 1 | 50090-4656 | CAPSULE | 100 mg | ORAL | ANDA | 23 sections |
Progesterone | Human Prescription Drug Label | 1 | 50090-5928 | CAPSULE | 100 mg | ORAL | ANDA | 22 sections |
Bijuva | HUMAN PRESCRIPTION DRUG LABEL | 2 | 50261-211 | CAPSULE | 100 mg | ORAL | NDA | 33 sections |
Progesterone | HUMAN PRESCRIPTION DRUG LABEL | 1 | 53002-1760 | CAPSULE | 200 mg | ORAL | ANDA | 23 sections |
Prometrium | HUMAN PRESCRIPTION DRUG LABEL | 1 | 54868-4230 | CAPSULE | 200 mg | ORAL | NDA | 15 sections |
Prometrium | HUMAN PRESCRIPTION DRUG LABEL | 1 | 54868-4250 | CAPSULE | 100 mg | ORAL | NDA | 15 sections |
Prochieve | HUMAN PRESCRIPTION DRUG LABEL | 1 | 55056-0406 | GEL | 45 mg | VAGINAL | NDA | 24 sections |
Crinone | HUMAN PRESCRIPTION DRUG LABEL | 1 | 55056-0806 | GEL | 90 mg | VAGINAL | NDA | 24 sections |
Crinone | HUMAN PRESCRIPTION DRUG LABEL | 1 | 55056-0808 | GEL | 45 mg | VAGINAL | NDA | 24 sections |
Crinone | HUMAN PRESCRIPTION DRUG LABEL | 1 | 55056-0818 | GEL | 90 mg | VAGINAL | NDA | 24 sections |
Prochieve | HUMAN PRESCRIPTION DRUG LABEL | 1 | 55056-1601 | GEL | 90 mg | VAGINAL | NDA | 24 sections |
Progesterone | Human Prescription Drug Label | 1 | 55150-306 | INJECTION, SOLUTION | 50 mg | INTRAMUSCULAR | ANDA | 16 sections |
Progesterone | Human Prescription Drug Label | 1 | 55150-306 | INJECTION, SOLUTION | 50 mg | INTRAMUSCULAR | ANDA | 16 sections |
ENDOMETRIN | HUMAN PRESCRIPTION DRUG LABEL | 1 | 55566-6500 | INSERT | 100 mg | VAGINAL | NDA | 26 sections |
ENDOMETRIN | HUMAN PRESCRIPTION DRUG LABEL | 1 | 55566-6500 | INSERT | 100 mg | VAGINAL | NDA | 26 sections |