misoprostol 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |

Stem definitionDrug idCAS RN
prostaglandins 1817 59122-46-2

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • misoprostol
  • cytotec
  • isprelor
  • misoprost
  • misoprostil
A synthetic analog of natural prostaglandin E1. It produces a dose-related inhibition of gastric acid and pepsin secretion, and enhances mucosal resistance to injury. It is an effective anti-ulcer agent and also has oxytocic properties.
  • Molecular weight: 382.54
  • Formula: C22H38O5
  • CLOGP: 3.07
  • LIPINSKI: 0
  • HAC: 5
  • HDO: 2
  • TPSA: 83.83
  • ALOGS: -4.37
  • ROTB: 14
  • Status: OFP
    • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
0.80 mg O
0.20 mg O
0.20 mg V

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 1 Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 0.50 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 0.03 µM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 80 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H

Predicted pharmacokinetic/toxicological properties (PK-AZ):

PropertyDescriptionValueUnitConfidenceSimilarity
kinase-safety-class ACVR2A,ACVR2B,ACVRL1,AKT2,AURKA,AXL,BRAF,BTK,CAMK2B,CAMK2D,CDK4,CDK5,CDK9,DDR1,DYRK1B,EGFR,EIF2AK3,EPHB4,ERBB2,FLT3,GRK2,GSK3B,IKBKB,ITK,JAK2,JAK3,MAP2K6,MAP3K21,MAP3K7,MAPK10,MAPK7,MAPKAPK2,MTOR,NTRK2,PDK1,PDK2,PDK4,PDPK1,PIK3CB,PIK3CG,PIM2,PLK1,PLK2,PLK3,PRKDC,SIK2,SIK3,STK33,SYK,TEK,TGFBR1,TTK,ZAP70 53
kinase-selectivity-class AXL,EIF2AK3,EPHB4,GRK2,MAP2K6,TEK 6
pfas-class PFAS structural alert (1 = True, 0 = False) 0

Approvals:

DateAgencyCompanyOrphan
Dec. 27, 1988 FDA GD SEARLE LLC
April 28, 2023 PMDA Linepharma K.K.

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
Abortion incomplete 9321.60 14.42 1438 22662 1702 90602645
Haemorrhage 4799.05 14.42 1418 22682 67951 90536396
Pregnancy 1408.14 14.42 552 23548 61495 90542852
Endometritis 954.99 14.42 179 23921 1021 90603326
Heavy menstrual bleeding 686.00 14.42 243 23857 20287 90584060
Anaemia 564.33 14.42 574 23526 352228 90252119
Induced abortion failed 346.37 14.42 58 24042 147 90604200
Muscle spasms 307.43 14.42 356 23744 251527 90352820
Exposure during pregnancy 277.61 14.42 329 23771 238081 90366266
Uterine rupture 272.02 14.42 63 24037 1106 90603241
Foetal exposure during pregnancy 250.60 14.42 151 23949 42824 90561523
Retained products of conception 243.97 14.42 41 24059 107 90604240
Vaginal haemorrhage 216.96 14.42 123 23977 31148 90573199
Complication of device insertion 198.56 14.42 82 24018 10354 90593993
Drug ineffective for unapproved indication 192.76 14.42 152 23948 66492 90537855
Bloody discharge 180.53 14.42 52 24048 2211 90602136
Post abortion haemorrhage 162.80 14.42 27 24073 63 90604284
International normalised ratio fluctuation 160.36 14.42 51 24049 3042 90601305
Ectopic pregnancy 158.02 14.42 51 24049 3190 90601157
Intermenstrual bleeding 157.15 14.42 67 24033 9156 90595191
Pelvic inflammatory disease 154.72 14.42 44 24056 1786 90602561
Ruptured ectopic pregnancy 151.86 14.42 34 24066 509 90603838
Pelvic pain 150.39 14.42 76 24024 15281 90589066
Syncope 149.06 14.42 180 23920 132483 90471864
Lyme disease 144.32 14.42 51 24049 4211 90600136
Small for dates baby 136.31 14.42 51 24049 4956 90599391
Uterine haemorrhage 127.89 14.42 48 24052 4704 90599643
Abortion induced incomplete 124.26 14.42 19 24081 19 90604328
Abdominal pain 101.87 14.42 282 23818 395439 90208908
Postpartum haemorrhage 101.81 14.42 34 24066 2367 90601980
Stillbirth 97.60 14.42 45 24055 7398 90596949
Foetal methotrexate syndrome 96.37 14.42 18 24082 100 90604247
Post abortion infection 89.10 14.42 13 24087 6 90604341
Foetal death 86.45 14.42 59 24041 20664 90583683
Haemorrhage in pregnancy 85.00 14.42 29 24071 2156 90602191
Maternal exposure during delivery 82.69 14.42 33 24067 3813 90600534
Maternal exposure during pregnancy 79.52 14.42 243 23857 359820 90244527
Iron deficiency 78.16 14.42 42 24058 9570 90594777
Gestational diabetes 77.09 14.42 43 24057 10539 90593808
Uterine perforation 72.83 14.42 37 24063 7517 90596830
Dizziness 72.35 14.42 329 23771 588955 90015392
Peripheral swelling 71.48 14.42 12 24088 413094 90191253
Congenital multiplex arthrogryposis 70.42 14.42 13 24087 67 90604280
Chills 69.04 14.42 125 23975 131856 90472491
Arteriospasm coronary 67.68 14.42 31 24069 5019 90599328
Pemphigus 62.42 14.42 7 24093 326857 90277490
Pyrexia 60.78 14.42 340 23760 660145 89944202
Pain 60.65 14.42 462 23638 995879 89608468
Wrist deformity 60.09 14.42 25 24075 3213 90601134
Post abortion complication 57.47 14.42 9 24091 12 90604335
Systemic lupus erythematosus 55.39 14.42 14 24086 361882 90242465
Vaginal odour 53.82 14.42 15 24085 565 90603782
Uterine tenderness 53.14 14.42 9 24091 25 90604322
Abortion induced 52.34 14.42 35 24065 11853 90592494
Meconium in amniotic fluid 52.30 14.42 13 24087 311 90604036
Wound 51.95 14.42 9 24091 302971 90301376
Joint swelling 50.77 14.42 36 24064 503264 90101083
Embedded device 50.49 14.42 24 24076 4224 90600123
Infusion related reaction 50.27 14.42 24 24076 416756 90187591
Truncus arteriosus persistent 49.55 14.42 13 24087 388 90603959
Sinusitis 49.27 14.42 15 24085 343073 90261274
Procedural pain 48.87 14.42 52 24048 33308 90571039
Platelet count increased 48.60 14.42 42 24058 20817 90583530
Uterine tachysystole 46.78 14.42 8 24092 24 90604323
Congenital cardiovascular anomaly 46.76 14.42 13 24087 485 90603862
Pelvic infection 46.07 14.42 12 24088 348 90603999
Secretion discharge 45.36 14.42 36 24064 15860 90588487
Uterine dilation and curettage 45.28 14.42 15 24085 1018 90603329
Microcephaly 44.73 14.42 16 24084 1368 90602979
Glossodynia 44.55 14.42 15 24085 321764 90282583
Pericarditis 44.23 14.42 9 24091 270142 90334205
Arthropathy 42.78 14.42 22 24078 366220 90238127
Adactyly 42.75 14.42 8 24092 45 90604302
Heart disease congenital 42.00 14.42 16 24084 1633 90602714
Off label use 41.93 14.42 462 23638 1101790 89502557
Uterine atony 41.65 14.42 11 24089 337 90604010
Post procedural discomfort 41.45 14.42 15 24085 1326 90603021
Stomatitis 41.30 14.42 11 24089 274687 90329660
Cardiac septal defect 40.92 14.42 13 24087 772 90603575
Psoriatic arthropathy 40.89 14.42 6 24094 228329 90376018
Alopecia 40.70 14.42 43 24057 495028 90109319
Intentional product use issue 40.51 14.42 5 24095 216887 90387460
Uterine hyperstimulation 40.41 14.42 8 24092 63 90604284
Hepatic enzyme increased 40.19 14.42 23 24077 360713 90243634
Therapeutic product effect decreased 40.09 14.42 12 24088 277559 90326788
Anaphylactoid syndrome of pregnancy 40.08 14.42 8 24092 66 90604281
Confusional state 39.75 14.42 27 24073 386178 90218169
Induced abortion haemorrhage 39.24 14.42 6 24094 6 90604341
Uterine hypotonus 39.23 14.42 9 24091 151 90604196
General physical health deterioration 39.05 14.42 23 24077 355092 90249255
Craniosynostosis 38.43 14.42 9 24091 166 90604181
Staphylococcal infection 37.76 14.42 55 24045 48384 90555963
Fatigue 37.46 14.42 169 23931 1153854 89450493
Toxic shock syndrome 37.29 14.42 13 24087 1031 90603316
Cerebral ventricle dilatation 37.26 14.42 13 24087 1033 90603314
Weight increased 36.99 14.42 34 24066 417893 90186454
Abortion 36.96 14.42 17 24083 2778 90601569
Blister 36.87 14.42 11 24089 254987 90349360
Wheezing 36.81 14.42 9 24091 238071 90366276
Ventricular septal defect 36.76 14.42 21 24079 5386 90598961
Premature baby 36.57 14.42 39 24061 25038 90579309
Abdominal discomfort 36.46 14.42 44 24056 477284 90127063
Abnormal palmar/plantar creases 35.72 14.42 7 24093 52 90604295
Dysmorphism 35.15 14.42 16 24084 2552 90601795
Nasopharyngitis 35.00 14.42 34 24066 407070 90197277
Maternal drugs affecting foetus 34.98 14.42 20 24080 5135 90599212
Vomiting 34.91 14.42 341 23759 787952 89816395
Microgenia 34.38 14.42 6 24094 21 90604326
Endometritis bacterial 33.23 14.42 5 24095 4 90604343
Product complaint 33.12 14.42 28 24072 13472 90590875
Treatment failure 32.97 14.42 20 24080 303908 90300439
Lower respiratory tract infection 32.47 14.42 13 24087 250646 90353701
Helicobacter infection 32.41 14.42 10 24090 226840 90377507
Gastrointestinal disorder 32.14 14.42 14 24086 256673 90347674
Abortion infected 32.02 14.42 6 24094 34 90604313
Sleep disorder 31.58 14.42 7 24093 198023 90406324
Pre-eclampsia 31.48 14.42 25 24075 11023 90593324
Febrile neutropenia 31.22 14.42 3 24097 158346 90446001
Oral fibroma 30.12 14.42 6 24094 49 90604298
Respiratory disorder neonatal 30.04 14.42 12 24088 1389 90602958
Discomfort 29.83 14.42 18 24082 274317 90330030
Duodenal ulcer perforation 29.45 14.42 11 24089 221277 90383070
Oligohydramnios 28.84 14.42 20 24080 7181 90597166
Tongue oedema 28.79 14.42 18 24082 5436 90598911
Developmental hip dysplasia 28.61 14.42 12 24088 1573 90602774
Uterine hypertonus 28.41 14.42 8 24092 313 90604034
Uterine cervical laceration 28.33 14.42 5 24095 19 90604328
Uterine spasm 28.28 14.42 10 24090 827 90603520
Low birth weight baby 28.22 14.42 22 24078 9445 90594902
Fibromyalgia 27.87 14.42 10 24090 206259 90398088
Arthralgia 27.03 14.42 111 23989 778411 89825936
Ill-defined disorder 26.68 14.42 8 24092 184883 90419464
Infantile haemangioma 26.08 14.42 6 24094 102 90604245
Arnold-Chiari malformation 25.87 14.42 9 24091 709 90603638
Neutropenia 25.52 14.42 14 24086 224890 90379457
Low set ears 24.86 14.42 7 24093 274 90604073
Product dose omission issue 24.32 14.42 25 24075 291662 90312685
Atrial septal defect 24.25 14.42 19 24081 8215 90596132
Headache 24.10 14.42 133 23967 862613 89741734
Premature separation of placenta 24.03 14.42 12 24088 2350 90601997
Contraindicated product administered 23.91 14.42 30 24070 320109 90284238
Disseminated intravascular coagulation 23.78 14.42 29 24071 21509 90582838
Gait inability 23.71 14.42 5 24095 146451 90457896
Retained placenta or membranes 23.62 14.42 7 24093 329 90604018
Prominent epicanthal folds 23.59 14.42 5 24095 57 90604290
Polyhydramnios 23.35 14.42 12 24088 2496 90601851
Congenital joint malformation 22.92 14.42 4 24096 14 90604333
Device placement issue 22.70 14.42 11 24089 2019 90602328
Movement disorder 22.68 14.42 33 24067 28986 90575361
Victim of homicide 22.64 14.42 5 24095 70 90604277
Type 2 diabetes mellitus 22.56 14.42 13 24087 203231 90401116
Pregnancy with contraceptive device 22.50 14.42 15 24085 5051 90599296
Synovitis 22.50 14.42 33 24067 329719 90274628
Tachycardia 22.28 14.42 92 24008 157581 90446766
Caesarean section 22.13 14.42 26 24074 18551 90585796
Device dislocation 22.04 14.42 34 24066 31448 90572899
Impaired healing 21.98 14.42 18 24082 234181 90370166
Dry mouth 21.55 14.42 11 24089 184048 90420299
Hospitalisation 21.52 14.42 4 24096 128096 90476251
COVID-19 21.46 14.42 9 24091 168834 90435513
Rash 21 14.42 125 23975 795975 89808372
Spina bifida 20.49 14.42 8 24092 872 90603475
Abdominal pain lower 20.30 14.42 32 24068 30145 90574202
Uterine disorder 20.26 14.42 12 24088 3289 90601058
Varicose veins vulval 20.26 14.42 5 24095 116 90604231
Diarrhoea 20.05 14.42 157 23943 939033 89665314
Device difficult to use 20.00 14.42 24 24076 17501 90586846
Migraine 19.98 14.42 13 24087 190379 90413968
Death 19.91 14.42 59 24041 456492 90147855
Musculoskeletal stiffness 19.91 14.42 30 24070 296502 90307845
Micrognathia 19.79 14.42 6 24094 305 90604042
Anonychia 19.62 14.42 3 24097 3 90604344
Nail aplasia 19.62 14.42 3 24097 3 90604344
Intrauterine infection 19.54 14.42 5 24095 135 90604212
Congenital choroid plexus cyst 19.28 14.42 6 24094 333 90604014
Inflammation 19.01 14.42 12 24088 178580 90425767
Musculoskeletal pain 18.94 14.42 11 24089 171240 90433107
Pruritus 18.89 14.42 77 24023 541448 90062899
Adverse drug reaction 18.85 14.42 4 24096 116697 90487650
Liver injury 18.80 14.42 11 24089 170556 90433791
Foetal heart rate deceleration abnormality 18.79 14.42 7 24093 672 90603675
Dysmenorrhoea 18.77 14.42 13 24087 4659 90599688
Anaemia of pregnancy 18.66 14.42 5 24095 162 90604185
Wound infection 18.58 14.42 3 24097 106399 90497948
Uterine cervix stenosis 18.56 14.42 6 24094 377 90603970
Microphthalmos 18.40 14.42 5 24095 171 90604176
Foetal heart rate disorder 18.32 14.42 5 24095 174 90604173
Congenital myopia 18.32 14.42 4 24096 53 90604294
Gross motor delay 18.21 14.42 5 24095 178 90604169
Irritable bowel syndrome 18.18 14.42 17 24083 207431 90396916
Synostosis 18.05 14.42 4 24096 57 90604290
Injection site pain 18.04 14.42 12 24088 173687 90430660
Dyspnoea 17.99 14.42 149 23951 880806 89723541
Urinary bladder rupture 17.75 14.42 5 24095 196 90604151
Swelling 17.67 14.42 55 24045 419003 90185344
Toxicity to various agents 17.57 14.42 31 24069 287815 90316532
Sciatica 17.38 14.42 3 24097 101379 90502968
Breast tenderness 17.37 14.42 10 24090 2602 90601745
Anaphylactic reaction 17.35 14.42 57 24043 87467 90516880
Abnormal labour 17.28 14.42 4 24096 70 90604277
Hyponatraemia 17.16 14.42 7 24093 133531 90470816
Congenital pneumonia 17.08 14.42 3 24097 11 90604336
Amniotic cavity infection 16.94 14.42 8 24092 1388 90602959
Uterine infection 16.91 14.42 6 24094 501 90603846
Gait disturbance 16.87 14.42 27 24073 260469 90343878
Impaired work ability 16.61 14.42 23 24077 19303 90585044
Uterine contractions abnormal 16.55 14.42 5 24095 251 90604096
Condition aggravated 16.49 14.42 92 24008 595453 90008894
Pneumonia 16.38 14.42 101 23999 637958 89966389
Retrognathia 16.29 14.42 6 24094 558 90603789
Circulatory collapse 16.19 14.42 26 24074 24878 90579469
Ectrodactyly 16.17 14.42 3 24097 16 90604331
Night sweats 16.14 14.42 7 24093 128759 90475588
Acute pulmonary oedema 15.95 14.42 16 24084 9564 90594783
Purpura senile 15.78 14.42 6 24094 609 90603738
Limb reduction defect 15.66 14.42 6 24094 622 90603725
Pelvic kidney 15.60 14.42 4 24096 109 90604238
Genital haemorrhage 15.35 14.42 15 24085 8687 90595660
Phalangeal hypoplasia 15.34 14.42 3 24097 22 90604325
Adverse event 15.34 14.42 6 24094 117412 90486935
Insomnia 15.34 14.42 42 24058 333432 90270915
Abortion spontaneous 15.33 14.42 40 24060 54016 90550331
Fall 15.28 14.42 71 24029 481739 90122608
Hypercholesterolaemia 15.23 14.42 4 24096 100888 90503459
Memory impairment 15.23 14.42 18 24082 197226 90407121
Weight decreased 15.22 14.42 51 24049 379859 90224488
Rheumatoid arthritis 14.99 14.42 48 24052 362566 90241781
Cervix enlargement 14.90 14.42 3 24097 26 90604321
Third stage postpartum haemorrhage 14.90 14.42 3 24097 26 90604321
Drug-induced liver injury 14.79 14.42 3 24097 90315 90514032
Disease progression 14.73 14.42 12 24088 156603 90447744
Loss of personal independence in daily activities 14.68 14.42 9 24091 136096 90468251
Premature rupture of membranes 14.61 14.42 12 24088 5546 90598801
Prescribed overdose 14.49 14.42 4 24096 97621 90506726

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
Foetal exposure during pregnancy 341.64 16.51 153 5585 47158 42568439
Ventricular septal defect 96.35 16.51 32 5706 4367 42611230
Maternal exposure during pregnancy 92.67 16.51 35 5703 6943 42608654
Atrial septal defect 74.61 16.51 31 5707 7888 42607709
Anencephaly 72.10 16.51 13 5725 126 42615471
Nail bed bleeding 62.03 16.51 14 5724 444 42615153
Premature baby 55.29 16.51 36 5702 23117 42592480
Congenital hydrocephalus 50.32 16.51 10 5728 169 42615428
Pulmonary hypoplasia 49.95 16.51 12 5726 502 42615095
Poor weight gain neonatal 47.38 16.51 7 5731 15 42615582
Congenital megaureter 45.69 16.51 9 5729 145 42615452
Renal aplasia 44.94 16.51 12 5726 771 42614826
Micrognathia 44.71 16.51 10 5728 304 42615293
Meningocele 43.38 16.51 7 5731 32 42615565
Stillbirth 43.25 16.51 9 5729 193 42615404
Neonatal respiratory arrest 42.53 16.51 7 5731 37 42615560
Congenital cystic kidney disease 40.96 16.51 10 5728 448 42615149
Moebius II syndrome 39.57 16.51 5 5733 0 42615597
Foetal growth restriction 37.69 16.51 17 5721 5266 42610331
Congenital cystic lung 36.44 16.51 8 5730 223 42615374
Anomaly of external ear congenital 35.46 16.51 7 5731 114 42615483
Spinal osteoarthritis 35.17 16.51 19 5719 8667 42606930
Newborn persistent pulmonary hypertension 34.70 16.51 7 5731 128 42615469
Respiratory disorder neonatal 34.02 16.51 12 5726 1958 42613639
Heart disease congenital 33.61 16.51 11 5727 1431 42614166
Intervertebral disc compression 32.52 16.51 8 5730 370 42615227
External auditory canal atresia 32.28 16.51 7 5731 184 42615413
Off label use 31.66 16.51 24 5714 638311 41977286
Persistent left superior vena cava 30.96 16.51 5 5733 23 42615574
Genitalia external ambiguous 30.68 16.51 7 5731 233 42615364
Grip strength decreased 30.30 16.51 13 5725 3575 42612022
Red blood cell sedimentation rate increased 30.17 16.51 18 5720 9906 42605691
Congenital diaphragmatic hernia 30.13 16.51 7 5731 253 42615344
Thrombocytosis 29.79 16.51 14 5724 4761 42610836
Haemangioma congenital 29.70 16.51 8 5730 531 42615066
Maternal drugs affecting foetus 29.46 16.51 13 5725 3826 42611771
Paternal exposure before pregnancy 27.68 16.51 5 5733 49 42615548
Patent ductus arteriosus 27.41 16.51 12 5726 3464 42612133
Pleuritic pain 27.32 16.51 15 5723 7062 42608535
Congenital pulmonary valve atresia 26.91 16.51 5 5733 58 42615539
Retroperitoneal fibrosis 26.28 16.51 7 5731 445 42615152
Anal fissure 25.60 16.51 13 5725 5226 42610371
Cleft lip and palate 25.37 16.51 8 5730 924 42614673
Interstitial lung disease 25.25 16.51 41 5697 78421 42537176
Oesophageal atresia 25.19 16.51 7 5731 522 42615075
Blood albumin decreased 25.19 16.51 19 5719 15383 42600214
Tracheo-oesophageal fistula 24.85 16.51 7 5731 549 42615048
Joint effusion 24.15 16.51 13 5725 5884 42609713
Congenital tricuspid valve atresia 24.08 16.51 5 5733 106 42615491
Double outlet right ventricle 23.37 16.51 5 5733 123 42615474
Rheumatoid arthritis 22.26 16.51 28 5710 42412 42573185
Kidney duplex 22.18 16.51 6 5732 405 42615192
Agitation neonatal 22.03 16.51 8 5730 1420 42614177
Talipes 21.89 16.51 9 5729 2227 42613370
Hyperbilirubinaemia neonatal 21.80 16.51 7 5731 857 42614740
Death 21.70 16.51 19 5719 471166 42144431
Rash macular 21.54 16.51 18 5720 16873 42598724
Skin discolouration 20.13 16.51 19 5719 20871 42594726
Pain in jaw 19.63 16.51 16 5722 14486 42601111
Arachnoid cyst 19.53 16.51 5 5733 272 42615325
Craniofacial deformity 19.04 16.51 4 5734 90 42615507
Pleural effusion 18.99 16.51 41 5697 97125 42518472
Congenital central nervous system anomaly 18.98 16.51 6 5732 699 42614898
Epilepsy congenital 18.91 16.51 3 5735 12 42615585
C-reactive protein increased 18.81 16.51 32 5706 63528 42552069
Cerebellar hypoplasia 18.72 16.51 3 5735 13 42615584
Gastric ulcer haemorrhage 18.33 16.51 11 5727 6116 42609481
Retinal scar 17.95 16.51 5 5733 376 42615221
Dysstasia 17.93 16.51 15 5723 14071 42601526
Hypoaesthesia 17.34 16.51 33 5705 71430 42544167
Congenital bowing of long bones 17.27 16.51 3 5735 23 42615574
Low set ears 16.52 16.51 5 5733 504 42615093

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
Abortion incomplete 9532.28 14.40 1427 23034 1645 110563193
Haemorrhage 4379.34 14.40 1400 23061 105292 110459546
Pregnancy 1573.11 14.40 542 23919 50525 110514313
Endometritis 984.92 14.40 173 24288 801 110564037
Heavy menstrual bleeding 754.60 14.40 236 24225 16129 110548709
Anaemia 454.32 14.40 580 23881 546506 110018332
Muscle spasms 323.46 14.40 351 24110 277806 110287032
Exposure during pregnancy 294.60 14.40 265 24196 167159 110397679
Induced abortion failed 268.78 14.40 44 24417 119 110564719
Retained products of conception 253.50 14.40 41 24420 100 110564738
Uterine rupture 250.05 14.40 53 24408 738 110564100
Vaginal haemorrhage 215.45 14.40 107 24354 24967 110539871
Complication of device insertion 215.31 14.40 79 24382 8759 110556079
Bloody discharge 189.25 14.40 54 24407 2679 110562159
Ectopic pregnancy 184.62 14.40 51 24410 2246 110562592
Post abortion haemorrhage 177.61 14.40 28 24433 54 110564784
Pelvic inflammatory disease 169.15 14.40 44 24417 1536 110563302
International normalised ratio fluctuation 163.82 14.40 53 24408 4027 110560811
Lyme disease 160.90 14.40 53 24408 4263 110560575
Pelvic pain 157.93 14.40 75 24386 15867 110548971
Intermenstrual bleeding 154.30 14.40 58 24403 6876 110557962
Ruptured ectopic pregnancy 150.47 14.40 32 24429 453 110564385
Uterine haemorrhage 130.62 14.40 43 24418 3451 110561387
Pain 122.60 14.40 475 23986 954480 109610358
Syncope 118.32 14.40 182 24279 202354 110362484
Maternal exposure during pregnancy 116.48 14.40 205 24256 254678 110310160
Abortion induced incomplete 107.59 14.40 16 24445 16 110564822
Postpartum haemorrhage 98.65 14.40 30 24431 1859 110562979
Haemorrhage in pregnancy 93.61 14.40 28 24433 1640 110563198
Drug ineffective for unapproved indication 87.85 14.40 111 24350 102727 110462111
Abdominal pain 86.05 14.40 279 24182 512710 110052128
Post abortion infection 84.14 14.40 12 24449 6 110564832
Foetal death 80.61 14.40 48 24413 15997 110548841
Maternal exposure during delivery 79.97 14.40 30 24431 3535 110561303
Uterine perforation 79.64 14.40 36 24425 6804 110558034
Dizziness 78.74 14.40 334 24127 697859 109866979
Stillbirth 78.23 14.40 31 24430 4233 110560605
Gestational diabetes 76.98 14.40 36 24425 7353 110557485
Iron deficiency 67.07 14.40 45 24416 18431 110546407
Wrist deformity 64.92 14.40 25 24436 3164 110561674
Uterine tenderness 63.53 14.40 10 24451 19 110564819
Vaginal odour 59.78 14.40 15 24446 452 110564386
Meconium in amniotic fluid 58.10 14.40 12 24449 146 110564692
Uterine dilation and curettage 54.68 14.40 15 24446 643 110564195
Abortion induced 53.82 14.40 29 24432 7990 110556848
Arteriospasm coronary 53.08 14.40 30 24431 9070 110555768
Procedural pain 52.23 14.40 51 24410 35514 110529324
Uterine tachysystole 51.62 14.40 8 24453 13 110564825
Platelet count increased 50.83 14.40 44 24417 26290 110538548
Post abortion complication 46.59 14.40 7 24454 8 110564830
Nail bed bleeding 46.44 14.40 14 24447 842 110563996
Embedded device 46.23 14.40 21 24440 4012 110560826
Secretion discharge 45.64 14.40 37 24424 20207 110544631
Chills 44.71 14.40 117 24344 190463 110374375
Post procedural discomfort 41.82 14.40 14 24447 1183 110563655
Pyrexia 41.75 14.40 340 24121 897925 109666913
Maternal drugs affecting foetus 41.41 14.40 15 24446 1602 110563236
Uterine hypotonus 41.40 14.40 9 24452 142 110564696
Uterine atony 41.20 14.40 10 24451 262 110564576
Pre-eclampsia 41.18 14.40 25 24436 8625 110556213
Vomiting 40.88 14.40 342 24119 910333 109654505
Endometritis bacterial 40.87 14.40 6 24455 5 110564833
Febrile neutropenia 40.67 14.40 10 24451 316757 110248081
Induced abortion haemorrhage 40.34 14.40 6 24455 6 110564832
Death 38.94 14.40 59 24402 698810 109866028
Intentional product use issue 37.91 14.40 5 24456 247901 110316937
Abortion 37.39 14.40 14 24447 1640 110563198
Anaphylactoid syndrome of pregnancy 35.91 14.40 7 24454 62 110564776
Pain in jaw 35.62 14.40 50 24411 51127 110513711
Infusion related reaction 35.62 14.40 20 24441 381142 110183696
General physical health deterioration 34.73 14.40 26 24435 425269 110139569
Red blood cell sedimentation rate increased 34.43 14.40 62 24399 78240 110486598
Staphylococcal infection 34.15 14.40 58 24403 69886 110494952
Abortion infected 34.10 14.40 6 24455 28 110564810
Stomatitis 33.79 14.40 9 24452 270233 110294605
Gastrointestinal disorder 32.32 14.40 7 24454 241945 110322893
Peripheral swelling 31.35 14.40 26 24435 404008 110160830
Toxic shock syndrome 31.24 14.40 12 24449 1508 110563330
Therapeutic product effect decreased 30.80 14.40 8 24453 244308 110320530
Confusional state 30.76 14.40 35 24426 468645 110096193
Uterine hypertonus 30.67 14.40 8 24453 282 110564556
Acute kidney injury 30.47 14.40 59 24402 635371 109929467
Toxicity to various agents 29.30 14.40 38 24423 480517 110084321
Pregnancy with contraceptive device 28.68 14.40 15 24446 3892 110560946
Small for dates baby 28.21 14.40 9 24452 653 110564185
Wound 27.13 14.40 9 24452 234428 110330410
Retained placenta or membranes 26.57 14.40 7 24454 257 110564581
Uterine hyperstimulation 25.89 14.40 5 24456 42 110564796
Device placement issue 25.81 14.40 11 24450 1806 110563032
Pemphigus 25.25 14.40 8 24453 214562 110350276
Polyhydramnios 25.15 14.40 11 24450 1922 110562916
Joint swelling 25.01 14.40 37 24424 442808 110122030
Weight increased 24.75 14.40 34 24427 419610 110145228
Abortion spontaneous 24.61 14.40 34 24427 34248 110530590
Uterine spasm 24.47 14.40 8 24453 628 110564210
Sinusitis 24.39 14.40 18 24443 296670 110268168
Product complaint 24.28 14.40 22 24439 13950 110550888
Premature separation of placenta 23.89 14.40 10 24451 1570 110563268
Abnormal labour 23.88 14.40 4 24457 13 110564825
Completed suicide 23.69 14.40 12 24449 242369 110322469
Pelvic infection 23.45 14.40 7 24454 407 110564431
Uterine disorder 23.20 14.40 11 24450 2315 110562523
Dyspnoea 23.04 14.40 147 24314 1106725 109458113
Wheezing 22.97 14.40 14 24447 255216 110309622
Arthropathy 22.92 14.40 18 24443 287504 110277334
Tongue oedema 22.76 14.40 17 24444 8239 110556599
Uterine cervical laceration 22.68 14.40 4 24457 19 110564819
Blister 22.61 14.40 11 24450 227365 110337473
Treatment failure 22.55 14.40 17 24444 277217 110287621
Abortion complete 22.25 14.40 3 24458 0 110564838
Product dose omission issue 22.24 14.40 23 24438 321759 110243079
Device dislocation 22.10 14.40 31 24430 31673 110533165
Injection site pain 22.09 14.40 6 24455 177916 110386922
Psoriatic arthropathy 22.00 14.40 8 24453 196753 110368085
Glossodynia 21.68 14.40 11 24450 221993 110342845
Anaemia of pregnancy 21.39 14.40 5 24456 111 110564727
Varicose veins vulval 21.18 14.40 5 24456 116 110564722
Disseminated intravascular coagulation 21.17 14.40 35 24426 41251 110523587
Lower respiratory tract infection 20.97 14.40 14 24447 243092 110321746
Hyponatraemia 20.93 14.40 11 24450 217642 110347196
Sleep disorder 20.69 14.40 9 24452 198635 110366203
Device difficult to use 20.50 14.40 23 24438 18782 110546056
Systemic lupus erythematosus 20.17 14.40 16 24445 254322 110310516
Genital haemorrhage 20.14 14.40 15 24446 7237 110557601
Hepatic enzyme increased 19.93 14.40 25 24436 320867 110243971
Uterine cervical pain 19.82 14.40 4 24457 43 110564795
Pericarditis 19.74 14.40 12 24449 219102 110345736
Infection 19.47 14.40 142 24319 362058 110202780
Hospitalisation 19.28 14.40 4 24457 142489 110422349
Blood albumin decreased 19.22 14.40 27 24434 27625 110537213
Uterine infection 19.20 14.40 6 24455 407 110564431
Breast tenderness 18.99 14.40 10 24451 2630 110562208
Movement disorder 18.85 14.40 31 24430 36373 110528465
COVID-19 18.71 14.40 16 24445 245044 110319794
Disease progression 18.55 14.40 16 24445 244018 110320820
Vaginal discharge 18.00 14.40 21 24440 17887 110546951
Dry mouth 17.94 14.40 11 24450 199937 110364901
Intrauterine infection 17.80 14.40 4 24457 74 110564764
Neutropenia 17.75 14.40 35 24426 374585 110190253
Nasopharyngitis 17.70 14.40 38 24423 394323 110170515
Abdominal discomfort 17.64 14.40 38 24423 393820 110171018
Oligohydramnios 17.63 14.40 11 24450 3983 110560855
Foetal exposure during pregnancy 17.51 14.40 14 24447 7491 110557347
Victim of homicide 17.33 14.40 5 24456 258 110564580
Abdominal pain lower 17.00 14.40 30 24431 37253 110527585
Caesarean section 16.98 14.40 18 24443 13799 110551039
Diarrhoea 16.87 14.40 166 24295 1139339 109425499
Fatigue 16.83 14.40 180 24281 1215778 109349060
Hysterectomy 16.56 14.40 14 24447 8100 110556738
Ill-defined disorder 16.51 14.40 7 24454 156846 110407992
Bacterial vulvovaginitis 16.37 14.40 6 24455 662 110564176
Complication of device removal 16.16 14.40 11 24450 4609 110560229
Dysmenorrhoea 16.08 14.40 10 24451 3600 110561238
Fibromyalgia 15.90 14.40 9 24452 170900 110393938
Impaired work ability 15.76 14.40 24 24437 26395 110538443
Condition aggravated 15.55 14.40 97 24364 734739 109830099
Cervix enlargement 15.45 14.40 3 24458 26 110564812
Third stage postpartum haemorrhage 15.45 14.40 3 24458 26 110564812
Weight decreased 15.09 14.40 53 24408 468004 110096834
Therapy non-responder 15.05 14.40 8 24453 157299 110407539
Urinary bladder rupture 14.71 14.40 4 24457 166 110564672
Migraine 14.64 14.40 10 24451 171642 110393196
Tachycardia 14.64 14.40 93 24368 226552 110338286

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC A02BB01 ALIMENTARY TRACT AND METABOLISM
DRUGS FOR ACID RELATED DISORDERS
DRUGS FOR PEPTIC ULCER AND GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD)
Prostaglandins
ATC G02AD06 GENITO URINARY SYSTEM AND SEX HORMONES
OTHER GYNECOLOGICALS
UTEROTONICS
Prostaglandins
ATC M01AE56 MUSCULO-SKELETAL SYSTEM
ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS
ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS, NON-STEROIDS
Propionic acid derivatives
FDA CS M0017811 Prostaglandins E, Synthetic
MeSH PA D000020 Abortifacient Agents, Nonsteroidal
MeSH PA D000897 Anti-Ulcer Agents
MeSH PA D005765 Gastrointestinal Agents
MeSH PA D010120 Oxytocics
MeSH PA D012102 Reproductive Control Agents
FDA EPC N0000175785 Prostaglandin E1 Analog
CHEBI has role CHEBI:33282 antibacterial agent
CHEBI has role CHEBI:35441 antiinfective agent
CHEBI has role CHEBI:35480 analgesic
CHEBI has role CHEBI:35610 antineoplastic agent
CHEBI has role CHEBI:36063 oxytocic
CHEBI has role CHEBI:49201 anti-ulcer drug
CHEBI has role CHEBI:50691 abortifacient
CHEBI has role CHEBI:67079 anti-inflammatory agent
CHEBI has role CHEBI:74518 anti-obesity agent

Related Drugs by ATC class:

A02BB Prostaglandins 1 drug
enprostil
G02AD Prostaglandins 5 drugs
carboprostdinoprostdinoprostonegemeprostsulprostone
M01AE Propionic acid derivatives 21 drugs
alminoprofenbenoxaprofendexibuprofendexketoprofendiphenhydramineesomeprazolefenbufenfenoprofenflunoxaprofenflurbiprofenibuprofenibuproxam show all 21 →

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

DiseaseRelationSNOMED_IDDOID
Postpartum hemorrhage indication 47821001
Rheumatoid Arthritis in Patient at High Ulcer Risk indication
Prevention of NSAID-Induced Gastric Ulcer indication
Prevention of CMV Disease After Organ Transplant indication
Osteoarthritis in Patients at High Ulcer Risk indication
Ankylosing spondylitis off-label use 9631008 DOID:7147
Peptic ulcer off-label use 13200003 DOID:750
Duodenal ulcer disease off-label use 51868009 DOID:1724
Cervical ripening procedure off-label use 236959001
Pregnancy with abortive outcome off-label use 363681007
Gastric ulcer off-label use 397825006 DOID:10808
NSAID-Induced Gastric Ulcer off-label use
Alcoholism contraindication 7200002
Myocardial infarction contraindication 22298006 DOID:5844
Inflammatory bowel disease contraindication 24526004 DOID:0050589
Dehydration contraindication 34095006
Hypertensive disorder contraindication 38341003 DOID:10763
Gastrointestinal ulcer contraindication 40845000
Body fluid retention contraindication 43498006
Chronic heart failure contraindication 48447003
Disorder of cardiovascular system contraindication 49601007 DOID:1287
Gastrointestinal perforation contraindication 51875005
Acute nephropathy contraindication 58574008
Hepatic failure contraindication 59927004
Blood coagulation disorder contraindication 64779008 DOID:1247
Gastrointestinal hemorrhage contraindication 74474003
Liver function tests abnormal contraindication 166603001
Asthma contraindication 195967001 DOID:2841
Deliveries by cesarean contraindication 200144004
Non-infective meningitis contraindication 230155003
Cerebrovascular accident contraindication 230690007
Coronary artery bypass graft contraindication 232717009
Disease of liver contraindication 235856003 DOID:409
Drug-induced hepatitis contraindication 235876009
Edema contraindication 267038008
Anemia contraindication 271737000 DOID:2355
Pregnancy, function contraindication 289908002
Cardiovascular event risk contraindication 395112001
Smokes tobacco daily contraindication 449868002
Uterine Rupture in Pregnancy contraindication
Bloody Vomit contraindication
Gynecological Surgery contraindication




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

None

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])		Mechanism
action		Bioact sourceMoA source
Prostaglandin E2 receptor EP3 subtype GPCR AGONIST Ki 8.10 IUPHAR CHEMBL
Prostaglandin E2 receptor EP2 subtype GPCR AGONIST Ki 7.50 IUPHAR
Prostaglandin E2 receptor EP4 subtype GPCR AGONIST Ki 7.60 IUPHAR
Prostaglandin F2-alpha receptor GPCR Ki 5.03 PDSP

External reference:

IDSource
4019313 VUID
N0000147506 NUI
D00419 KEGG_DRUG
4019313 VANDF
C0085174 UMLSCUI
CHEBI:63610 CHEBI
CHEMBL606 ChEMBL_ID
DB00929 DRUGBANK_ID
D016595 MESH_DESCRIPTOR_UI
5282381 PUBCHEM_CID
5154 INN_ID
0E43V0BB57 UNII
151578 RXNORM
44310 MMSL
445 MMSL
5121 MMSL
d00303 MMSL
001133 NDDF
387242007 SNOMEDCT_US
43684009 SNOMEDCT_US
C0377863 UMLSCUI
CHEMBL1201377 ChEMBL_ID
66792-31-2 SECONDARY_CAS_RN
6436406 PUBCHEM_CID
C047042 MESH_SUPPLEMENTAL_RECORD_UI
12Z0SU967A UNII
CHEBI:749416 CHEBI
0E43V0BB57 INXIGHT DRUGS

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
ARTHROTEC HUMAN PRESCRIPTION DRUG LABEL 2 0025-1411 TABLET, FILM COATED 200 ug ORAL NDA 31 sections
ARTHROTEC HUMAN PRESCRIPTION DRUG LABEL 2 0025-1421 TABLET, FILM COATED 200 ug ORAL NDA 31 sections
Cytotec HUMAN PRESCRIPTION DRUG LABEL 1 0025-1451 TABLET 100 ug ORAL NDA 28 sections
Cytotec HUMAN PRESCRIPTION DRUG LABEL 1 0025-1461 TABLET 200 ug ORAL NDA 28 sections
Diclofenac Sodium and Misoprostol HUMAN PRESCRIPTION DRUG LABEL 2 0591-0397 TABLET, DELAYED RELEASE 200 ug ORAL ANDA 28 sections
Diclofenac Sodium and Misoprostol HUMAN PRESCRIPTION DRUG LABEL 2 0591-0398 TABLET, DELAYED RELEASE 200 ug ORAL ANDA 28 sections
Misoprostol HUMAN PRESCRIPTION DRUG LABEL 1 10135-745 TABLET 100 ug ORAL ANDA 20 sections
Misoprostol HUMAN PRESCRIPTION DRUG LABEL 1 10135-746 TABLET 200 ug ORAL ANDA 20 sections
Diclofenac Sodium and Misoprostol HUMAN PRESCRIPTION DRUG LABEL 2 10544-949 TABLET, DELAYED RELEASE 200 ug ORAL ANDA 24 sections
Diclofenac Sodium and MisoprostolDelayed-Release HUMAN PRESCRIPTION DRUG LABEL 2 10544-955 TABLET, DELAYED RELEASE 0.20 mg ORAL ANDA 30 sections
misoprostol HUMAN PRESCRIPTION DRUG LABEL 1 12634-502 TABLET 200 ug ORAL NDA authorized generic 27 sections
CYTOTEC HUMAN PRESCRIPTION DRUG LABEL 1 12634-933 TABLET 200 ug ORAL NDA 13 sections
ARTHROTEC HUMAN PRESCRIPTION DRUG LABEL 2 16590-024 TABLET, FILM COATED 200 ug ORAL NDA 31 sections
ARTHROTEC HUMAN PRESCRIPTION DRUG LABEL 2 21695-425 TABLET, FILM COATED 200 ug ORAL NDA 30 sections
Misoprostol HUMAN PRESCRIPTION DRUG LABEL 1 33261-076 TABLET 200 ug ORAL ANDA 15 sections
Misoprostol HUMAN PRESCRIPTION DRUG LABEL 1 33261-754 TABLET 100 ug ORAL ANDA 15 sections
Misoprostol HUMAN PRESCRIPTION DRUG LABEL 1 40032-160 TABLET 100 ug ORAL ANDA 22 sections
Misoprostol HUMAN PRESCRIPTION DRUG LABEL 1 40032-161 TABLET 200 ug ORAL ANDA 22 sections
Diclofenac Sodium and Misoprostol HUMAN PRESCRIPTION DRUG LABEL 2 42291-232 TABLET, DELAYED RELEASE 200 ug ORAL ANDA 27 sections
Diclofenac Sodium and Misoprostol HUMAN PRESCRIPTION DRUG LABEL 2 42291-233 TABLET, DELAYED RELEASE 200 ug ORAL ANDA 27 sections
Diclofenac Sodium and Misoprostol Delayed-Release HUMAN PRESCRIPTION DRUG LABEL 2 42367-110 TABLET, DELAYED RELEASE 0.20 mg ORAL ANDA 30 sections
Diclofenac Sodium and Misoprostol Delayed-Release HUMAN PRESCRIPTION DRUG LABEL 2 42367-111 TABLET, DELAYED RELEASE 0.20 mg ORAL ANDA 30 sections
Diclofenac Sodium/MisoprostolDICLOFENAC-SODIUM-MISOPROSTOL HUMAN PRESCRIPTION DRUG LABEL 2 42571-133 TABLET 200 ug ORAL ANDA 28 sections
Diclofenac Sodium/MisoprostolDICLOFENAC-SODIUM-MISOPROSTOL HUMAN PRESCRIPTION DRUG LABEL 2 42571-134 TABLET 200 ug ORAL ANDA 28 sections
MISOPROSTOL HUMAN PRESCRIPTION DRUG LABEL 1 42571-253 TABLET 100 ug ORAL ANDA 13 sections
MISOPROSTOL HUMAN PRESCRIPTION DRUG LABEL 1 42571-254 TABLET 200 ug ORAL ANDA 13 sections
Misoprostol HUMAN PRESCRIPTION DRUG LABEL 1 43063-707 TABLET 200 ug ORAL ANDA 22 sections
Misoprostol HUMAN PRESCRIPTION DRUG LABEL 1 43386-160 TABLET 100 ug ORAL ANDA 22 sections
Misoprostol HUMAN PRESCRIPTION DRUG LABEL 1 43386-161 TABLET 200 ug ORAL ANDA 22 sections
Misoprostol HUMAN PRESCRIPTION DRUG LABEL 1 43393-023 TABLET 200 ug ORAL ANDA 21 sections