misoprostol 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definition	Drug id	CAS RN
prostaglandins	1817	59122-46-2

Description:

Molecule	Description
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

Molecule

Description

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:

Dose	Unit	Route
0.80	mg	O
0.20	mg	O
0.20	mg	V

ADMET properties:

Property	Value	Reference
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

Approvals:

Date	Agency	Company	Orphan
Dec. 27, 1988	FDA	GD SEARLE LLC

FDA Adverse Event Reporting System (Female)

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
Abortion incomplete	8675.84	14.39	1433	19340	1693	50582658
Haemorrhage	4482.99	14.39	1399	19374	52042	50532309
Pregnancy	1570.34	14.39	551	20222	29026	50555325
Endometritis	908.52	14.39	178	20595	797	50583554
Heavy menstrual bleeding	642.01	14.39	241	20532	15296	50569055
Anaemia	502.05	14.39	565	20208	251891	50332460
Muscle spasms	364.55	14.39	345	20428	125208	50459143
Induced abortion failed	275.23	14.39	52	20721	183	50584168
Exposure during pregnancy	229.47	14.39	265	20508	120750	50463601
Drug ineffective for unapproved indication	222.02	14.39	127	20646	21154	50563197
Uterine rupture	191.75	14.39	51	20722	1024	50583327
Retained products of conception	181.00	14.39	33	20740	90	50584261
Ectopic pregnancy	152.88	14.39	51	20722	2276	50582075
Ruptured ectopic pregnancy	145.70	14.39	34	20739	388	50583963
Pelvic inflammatory disease	143.87	14.39	44	20729	1478	50582873
Vaginal haemorrhage	137.46	14.39	99	20674	24452	50559899
Intermenstrual bleeding	126.82	14.39	60	20713	6754	50577597
Pelvic pain	114.45	14.39	66	20707	11147	50573204
Syncope	110.62	14.39	171	20602	102831	50481520
Abdominal pain	99.07	14.39	265	20508	235963	50348388
Uterine haemorrhage	98.85	14.39	41	20732	3374	50580977
Abortion induced incomplete	92.63	14.39	15	20758	13	50584338
Post abortion infection	83.46	14.39	13	20760	6	50584345
Foetal exposure during pregnancy	82.57	14.39	77	20696	27282	50557069
Pyrexia	73.15	14.39	329	20444	379874	50204477
Foetal death	72.61	14.39	44	20729	8136	50576215
Postpartum haemorrhage	71.59	14.39	27	20746	1727	50582624
Haemorrhage in pregnancy	68.64	14.39	26	20747	1683	50582668
Pain	68.45	14.39	438	20335	578465	50005886
Fatigue	65.99	14.39	119	20654	707482	49876869
Stillbirth	63.32	14.39	36	20737	5916	50578435
Gestational diabetes	63.30	14.39	39	20734	7426	50576925
Small for dates baby	62.58	14.39	30	20743	3475	50580876
Complication of device insertion	60.16	14.39	35	20738	6006	50578345
Dizziness	57.98	14.39	288	20485	346081	50238270
Foetal methotrexate syndrome	57.44	14.39	12	20761	78	50584273
Maternal exposure during pregnancy	55.86	14.39	168	20605	159610	50424741
Arteriospasm coronary	54.38	14.39	27	20746	3375	50580976
Peripheral swelling	53.32	14.39	10	20763	205926	50378425
Product use in unapproved indication	51.54	14.39	133	20640	115686	50468665
Uterine perforation	48.09	14.39	31	20742	6384	50577967
Post abortion complication	47.48	14.39	8	20765	11	50584340
Vaginal odour	47.00	14.39	14	20759	429	50583922
Maternal exposure during delivery	46.62	14.39	17	20756	989	50583362
Wrist deformity	46.62	14.39	20	20753	1789	50582562
Chills	46.11	14.39	114	20659	96573	50487778
Uterine tenderness	45.28	14.39	8	20765	17	50584334
Death	39.80	14.39	45	20728	325334	50259017
Uterine hypotonus	38.87	14.39	9	20764	99	50584252
Pelvic infection	38.72	14.39	11	20762	284	50584067
Procedural pain	38.05	14.39	37	20736	13795	50570556
Embedded device	38.04	14.39	20	20753	2817	50581534
Uterine tachysystole	37.41	14.39	7	20766	23	50584328
Induced abortion haemorrhage	36.64	14.39	6	20767	6	50584345
Systemic lupus erythematosus	36.02	14.39	7	20766	140615	50443736
Microcephaly	34.90	14.39	13	20760	803	50583548
Uterine atony	33.72	14.39	9	20764	183	50584168
Product dose omission issue	33.21	14.39	17	20756	183821	50400530
Toxic shock syndrome	33.18	14.39	11	20762	481	50583870
Cerebral ventricle dilatation	33.15	14.39	13	20760	924	50583427
Uterine hyperstimulation	32.69	14.39	7	20766	52	50584299
Therapeutic product effect decreased	32.36	14.39	8	20765	136042	50448309
Sinusitis	31.98	14.39	15	20758	170543	50413808
Dysmorphism	31.13	14.39	16	20757	2151	50582200
Off label use	30.13	14.39	312	20461	474114	50110237
Toxicity to various agents	29.85	14.39	26	20747	212473	50371878
Alopecia	29.82	14.39	34	20739	245013	50339338
Respiratory disorder neonatal	29.62	14.39	12	20761	929	50583422
Abortion induced	29.54	14.39	27	20746	9317	50575034
Febrile neutropenia	29.35	14.39	3	20770	97664	50486687
Drug ineffective	29.27	14.39	207	20566	819126	49765225
Post procedural discomfort	29.15	14.39	12	20761	968	50583383
Joint swelling	28.81	14.39	35	20738	245251	50339100
Adactyly	28.21	14.39	6	20767	43	50584308
Abnormal palmar/plantar creases	28.09	14.39	6	20767	44	50584307
Congenital multiplex arthrogryposis	27.88	14.39	5	20768	12	50584339
Oral fibroma	27.10	14.39	6	20767	53	50584298
Uterine dilation and curettage	27.04	14.39	11	20762	861	50583490
Neutropenia	26.25	14.39	14	20759	147951	50436400
Abortion	25.74	14.39	14	20759	2110	50582241
Completed suicide	25.65	14.39	11	20762	131878	50452473
Abortion infected	25.57	14.39	5	20768	22	50584329
Arnold-Chiari malformation	25.39	14.39	9	20764	482	50583869
Craniosynostosis	25.29	14.39	7	20766	164	50584187
Endometritis bacterial	24.96	14.39	4	20769	3	50584348
Pre-eclampsia	24.95	14.39	23	20750	8021	50576330
Bloody discharge	23.89	14.39	11	20762	1163	50583188
Lower respiratory tract infection	23.83	14.39	5	20768	95196	50489155
Acute kidney injury	23.29	14.39	36	20737	228022	50356329
Product complaint	23.15	14.39	26	20747	11440	50572911
Meconium in amniotic fluid	22.66	14.39	7	20766	243	50584108
Uterine hypertonus	22.53	14.39	7	20766	248	50584103
Contraindicated product administered	22.43	14.39	17	20756	148941	50435410
Vaginal discharge	22.40	14.39	18	20755	5222	50579129
Confusional state	22.39	14.39	26	20747	185902	50398449
Infusion related reaction	22.32	14.39	22	20751	169535	50414816
Abdominal discomfort	22.31	14.39	38	20735	231603	50352748
Diarrhoea	22.27	14.39	146	20627	588330	49996021
Post abortion haemorrhage	22.02	14.39	5	20768	50	50584301
Injection site pain	22.01	14.39	9	20764	111015	50473336
Intentional product use issue	21.53	14.39	3	20770	76915	50507436
Infantile haemangioma	21.43	14.39	5	20768	57	50584294
Congenital joint malformation	21.41	14.39	4	20769	13	50584338
Victim of homicide	21.19	14.39	5	20768	60	50584291
Maternal exposure timing unspecified	21.17	14.39	15	20758	3605	50580746
Fall	21.03	14.39	69	20704	334863	50249488
Arthralgia	20.83	14.39	101	20672	438601	50145750
Maternal drugs affecting foetus	20.77	14.39	17	20756	5060	50579291
Microgenia	20.76	14.39	4	20769	16	50584335
Dyspnoea	20.64	14.39	136	20637	547472	50036879
Weight increased	20.49	14.39	32	20741	201859	50382492
Glossodynia	20.40	14.39	11	20762	115558	50468793
Hyponatraemia	20.38	14.39	7	20766	96132	50488219
Tongue oedema	20.38	14.39	15	20758	3824	50580527
Treatment failure	20.35	14.39	16	20757	137621	50446730
Hepatic enzyme increased	20.28	14.39	16	20757	137364	50446987
Arthropathy	20.20	14.39	21	20752	157885	50426466
Discomfort	19.59	14.39	10	20763	108370	50475981
Pruritus	19.52	14.39	56	20717	283512	50300839
Foetal heart rate disorder	19.41	14.39	5	20768	88	50584263
Device difficult to use	19.25	14.39	22	20751	9864	50574487
Nasopharyngitis	19.18	14.39	31	20742	192896	50391455
Spina bifida	18.93	14.39	8	20765	689	50583662
Rash	18.91	14.39	104	20669	437367	50146984
Micrognathia	18.73	14.39	6	20767	235	50584116
Polyhydramnios	18.24	14.39	11	20762	2014	50582337
Tachycardia	18.07	14.39	85	20688	99678	50484673
Low set ears	18.06	14.39	6	20767	264	50584087
Uterine spasm	18.05	14.39	7	20766	483	50583868
Uterine disorder	17.88	14.39	12	20761	2643	50581708
Gross motor delay	17.79	14.39	5	20768	124	50584227
Retained placenta or membranes	17.66	14.39	6	20767	283	50584068
Drug intolerance	17.59	14.39	40	20733	219064	50365287
International normalised ratio fluctuation	17.45	14.39	11	20762	2179	50582172
Premature separation of placenta	17.45	14.39	10	20763	1668	50582683
Pregnancy with contraceptive device	17.41	14.39	14	20759	4065	50580286
Anaphylactoid syndrome of pregnancy	17.27	14.39	4	20769	44	50584307
Cough	17.07	14.39	47	20726	241217	50343134
General physical health deterioration	17.05	14.39	20	20753	142414	50441937
Foetal exposure during delivery	17.03	14.39	4	20769	47	50584304
Headache	17.02	14.39	130	20643	506405	50077946
Congenital choroid plexus cyst	16.97	14.39	6	20767	319	50584032
Microphthalmos	16.92	14.39	5	20768	149	50584202
Vomiting	16.87	14.39	274	20499	460484	50123867
Third stage postpartum haemorrhage	16.79	14.39	3	20770	7	50584344
Abortion complete	16.79	14.39	3	20770	7	50584344
Synostosis	16.32	14.39	4	20769	57	50584294
Pneumonia	16.32	14.39	90	20683	378311	50206040
Thrombocytopenia	16.30	14.39	17	20756	127656	50456695
Hospitalisation	16.13	14.39	4	20769	67933	50516418
Congenital pneumonia	16.00	14.39	3	20770	10	50584341
Stomatitis	15.99	14.39	11	20762	101333	50483018
Lyme disease	15.95	14.39	11	20762	2532	50581819
Limb reduction defect	15.95	14.39	6	20767	381	50583970
Movement disorder	15.79	14.39	27	20746	17605	50566746
Weight decreased	15.73	14.39	43	20730	221202	50363149
Dysmenorrhoea	15.50	14.39	12	20761	3298	50581053
Breast tenderness	15.43	14.39	10	20763	2078	50582273
Uterine contractions abnormal	15.03	14.39	5	20768	221	50584130
Amniotic cavity infection	15.03	14.39	8	20765	1155	50583196
Premature baby	15.02	14.39	27	20746	18310	50566041
Uterine cervix stenosis	14.94	14.39	5	20768	225	50584126
Uterine cervical laceration	14.71	14.39	3	20770	17	50584334

FDA Adverse Event Reporting System (Male)

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	235.19	15.08	112	4561	33755	29536099
Maternal exposure during pregnancy	85.64	15.08	30	4643	4093	29565761
Anencephaly	70.02	15.08	13	4660	126	29569728
Premature baby	52.07	15.08	33	4640	17247	29552607
Pulmonary hypoplasia	50.28	15.08	12	4661	414	29569440
Congenital hydrocephalus	48.59	15.08	9	4664	86	29569768
Poor weight gain neonatal	46.26	15.08	7	4666	15	29569839
Congenital megaureter	45.43	15.08	9	4664	126	29569728
Renal aplasia	44.96	15.08	12	4661	654	29569200
Neonatal respiratory arrest	44.09	15.08	7	4666	23	29569831
Micrognathia	43.31	15.08	10	4663	298	29569556
Stillbirth	42.95	15.08	9	4664	169	29569685
Meningocele	42.26	15.08	7	4666	32	29569822
Congenital cystic kidney disease	40.79	15.08	10	4663	387	29569467
Foetal growth restriction	40.61	15.08	17	4656	3749	29566105
Moebius II syndrome	38.77	15.08	5	4668	0	29569854
Respiratory disorder neonatal	35.95	15.08	12	4661	1413	29568441
Congenital cystic lung	35.20	15.08	8	4665	222	29569632
Newborn persistent pulmonary hypertension	34.89	15.08	7	4666	105	29569749
Anomaly of external ear congenital	34.89	15.08	7	4666	105	29569749
Intervertebral disc compression	34.01	15.08	8	4665	259	29569595
Heart disease congenital	33.17	15.08	11	4662	1269	29568585
Cleft lip and palate	32.50	15.08	8	4665	315	29569539
External auditory canal atresia	31.42	15.08	7	4666	177	29569677
Genitalia external ambiguous	30.40	15.08	7	4666	206	29569648
Haemangioma congenital	29.04	15.08	8	4665	491	29569363
Congenital diaphragmatic hernia	28.75	15.08	7	4666	263	29569591
Retroperitoneal fibrosis	28.11	15.08	7	4666	289	29569565
Maternal drugs affecting foetus	27.29	15.08	13	4660	3880	29565974
Paternal exposure before pregnancy	26.97	15.08	5	4668	48	29569806
Interstitial lung disease	26.89	15.08	39	4634	57679	29512175
Patent ductus arteriosus	26.77	15.08	12	4661	3119	29566735
Congenital pulmonary valve atresia	26.35	15.08	5	4668	55	29569799
Congenital tricuspid valve atresia	23.20	15.08	5	4668	108	29569746
Double outlet right ventricle	23.15	15.08	5	4668	109	29569745
Talipes	22.42	15.08	9	4664	1783	29568071
Kidney duplex	21.27	15.08	6	4667	402	29569452
Atrial septal defect	20.52	15.08	13	4660	6776	29563078
Arachnoid cyst	20.18	15.08	5	4668	202	29569652
Gastric ulcer haemorrhage	18.95	15.08	11	4662	4903	29564951
Cerebellar hypoplasia	18.64	15.08	3	4670	11	29569843
Craniofacial deformity	18.49	15.08	4	4669	88	29569766
Hyperbilirubinaemia neonatal	17.73	15.08	6	4667	736	29569118
Spinal deformity	16.72	15.08	5	4668	412	29569442
Low set ears	16.48	15.08	5	4668	432	29569422
Death	16.40	15.08	18	4655	342066	29227788
Vesicoureteric reflux	16.36	15.08	4	4669	153	29569701
Congenital central nervous system anomaly	16.29	15.08	5	4668	450	29569404
Congenital bowing of long bones	16.26	15.08	3	4670	28	29569826
Foetal distress syndrome	15.99	15.08	6	4667	993	29568861
Neonatal respiratory distress syndrome	15.95	15.08	9	4664	3801	29566053
Congenital nose malformation	15.36	15.08	4	4669	198	29569656
Delayed fontanelle closure	15.35	15.08	3	4670	39	29569815
Hypertelorism	15.27	15.08	5	4668	554	29569300

FDA Adverse Event Reporting System (Geriatric)

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
Abortion incomplete	8969.85	14.49	1422	19388	1639	64476283
Haemorrhage	4221.42	14.49	1387	19423	77964	64399958
Pregnancy	1845.78	14.49	541	20269	20324	64457598
Endometritis	954.75	14.49	172	20638	594	64477328
Heavy menstrual bleeding	733.57	14.49	235	20575	11842	64466080
Anaemia	430.27	14.49	567	20243	378113	64099809
Muscle spasms	391.42	14.49	340	20470	140683	64337239
Exposure during pregnancy	281.71	14.49	219	20591	77456	64400466
Induced abortion failed	219.12	14.49	40	20770	151	64477771
Retained products of conception	190.30	14.49	33	20777	85	64477837
Uterine rupture	187.44	14.49	44	20766	669	64477253
Ectopic pregnancy	184.97	14.49	51	20759	1513	64476409
Pelvic inflammatory disease	162.63	14.49	44	20766	1214	64476708
Vaginal haemorrhage	143.37	14.49	85	20725	19259	64458663
Ruptured ectopic pregnancy	140.34	14.49	31	20779	353	64477569
Pain	136.09	14.49	439	20371	553072	63924850
Pelvic pain	131.07	14.49	66	20744	10844	64467078
Intermenstrual bleeding	125.59	14.49	51	20759	5074	64472848
Drug ineffective for unapproved indication	117.55	14.49	90	20720	31043	64446879
Uterine haemorrhage	104.27	14.49	37	20773	2542	64475380
Maternal exposure during pregnancy	99.57	14.49	138	20672	95746	64382176
Syncope	90.01	14.49	173	20637	157462	64320460
Abdominal pain	84.01	14.49	256	20554	312119	64165803
Abortion induced incomplete	83.55	14.49	13	20797	11	64477911
Haemorrhage in pregnancy	82.13	14.49	26	20784	1254	64476668
Foetal death	80.52	14.49	39	20771	5891	64472031
Post abortion infection	79.61	14.49	12	20798	6	64477916
Complication of device insertion	71.20	14.49	34	20776	4978	64472944
Postpartum haemorrhage	71.04	14.49	24	20786	1423	64476499
Gestational diabetes	70.63	14.49	35	20775	5555	64472367
Dizziness	63.05	14.49	290	20520	429873	64048049
Stillbirth	58.89	14.49	27	20783	3606	64474316
Uterine perforation	57.82	14.49	31	20779	5789	64472133
Vaginal odour	54.54	14.49	14	20796	313	64477609
Uterine tenderness	54.53	14.49	9	20801	15	64477907
Maternal exposure during delivery	52.67	14.49	17	20793	873	64477049
Wrist deformity	51.37	14.49	20	20790	1780	64476142
Pyrexia	49.15	14.49	328	20482	558316	63919606
Death	48.07	14.49	51	20759	482654	63995268
Arteriospasm coronary	45.74	14.49	26	20784	5439	64472483
Uterine hypotonus	43.28	14.49	9	20801	75	64477847
Embedded device	43.19	14.49	20	20790	2732	64475190
Completed suicide	42.70	14.49	10	20800	224404	64253518
Toxicity to various agents	42.61	14.49	33	20777	363480	64114442
Uterine tachysystole	42.29	14.49	7	20803	12	64477910
Procedural pain	42.06	14.49	37	20773	15471	64462451
Fatigue	40.86	14.49	116	20694	748614	63729308
Peripheral swelling	40.43	14.49	9	20801	209144	64268778
Acute kidney injury	39.85	14.49	52	20758	449188	64028734
Post abortion complication	38.60	14.49	6	20804	5	64477917
Induced abortion haemorrhage	38.08	14.49	6	20804	6	64477916
Uterine dilation and curettage	35.81	14.49	11	20799	480	64477442
Abortion induced	34.55	14.49	23	20787	6365	64471557
Febrile neutropenia	34.45	14.49	9	20801	187648	64290274
Post procedural discomfort	32.91	14.49	12	20798	891	64477031
Pre-eclampsia	32.66	14.49	22	20788	6209	64471713
Endometritis bacterial	32.26	14.49	5	20805	4	64477918
Chills	31.77	14.49	107	20703	137157	64340765
Uterine atony	31.69	14.49	8	20802	167	64477755
Vaginal discharge	30.75	14.49	18	20792	3979	64473943
Toxic shock syndrome	29.44	14.49	11	20799	875	64477047
Abortion infected	28.03	14.49	5	20805	16	64477906
Product dose omission issue	27.87	14.49	14	20796	194733	64283189
Dyspnoea	26.32	14.49	131	20679	718543	63759379
Meconium in amniotic fluid	26.15	14.49	6	20804	82	64477840
Maternal drugs affecting foetus	26.13	14.49	12	20798	1608	64476314
Abortion	25.89	14.49	11	20799	1225	64476697
Uterine hypertonus	24.81	14.49	7	20803	226	64477696
Small for dates baby	24.41	14.49	8	20802	431	64477491
Bloody discharge	24.01	14.49	11	20799	1466	64476456
Device difficult to use	23.85	14.49	22	20788	9776	64468146
Pregnancy with contraceptive device	23.64	14.49	14	20796	3160	64474762
Product use in unapproved indication	23.52	14.49	116	20694	176502	64301420
Pelvic infection	22.77	14.49	7	20803	306	64477616
Therapeutic product effect decreased	22.21	14.49	5	20805	115346	64362576
Neutropenia	21.97	14.49	27	20783	239597	64238325
Uterine disorder	21.84	14.49	11	20799	1806	64476116
Vomiting	21.22	14.49	271	20539	550846	63927076
Polyhydramnios	20.85	14.49	10	20800	1477	64476445
Hyponatraemia	20.72	14.49	11	20799	148328	64329594
Retained placenta or membranes	20.64	14.49	6	20804	216	64477706
Confusional state	20.39	14.49	33	20777	261111	64216811
Maternal exposure timing unspecified	20.32	14.49	12	20798	2695	64475227
Premature separation of placenta	20.12	14.49	9	20801	1135	64476787
Injection site pain	19.23	14.49	6	20804	111402	64366520
Uterine hyperstimulation	19.16	14.49	4	20806	34	64477888
Joint swelling	18.98	14.49	25	20785	215357	64262565
Lyme disease	18.90	14.49	11	20799	2404	64475518
Anaphylactoid syndrome of pregnancy	18.58	14.49	4	20806	40	64477882
Diarrhoea	18.54	14.49	147	20663	722557	63755365
Post abortion haemorrhage	17.91	14.49	4	20806	48	64477874
Breast tenderness	17.83	14.49	10	20800	2039	64475883
Abortion complete	17.82	14.49	3	20807	6	64477916
General physical health deterioration	17.74	14.49	24	20786	204401	64273521
Hysterectomy	17.66	14.49	14	20796	5071	64472851
Third stage postpartum haemorrhage	17.51	14.49	3	20807	7	64477915
Victim of homicide	17.42	14.49	5	20805	172	64477750
Uterine spasm	17.30	14.49	6	20804	385	64477537
International normalised ratio fluctuation	16.84	14.49	11	20799	2950	64474972
Product complaint	16.78	14.49	20	20790	11934	64465988
Infusion related reaction	16.74	14.49	17	20793	164450	64313472
Weight decreased	16.46	14.49	43	20767	285696	64192226
Oligohydramnios	16.30	14.49	11	20799	3113	64474809
Drug interaction	16.26	14.49	61	20749	362022	64115900
Bacterial vulvovaginitis	16.21	14.49	6	20804	465	64477457
Abnormal labour	16.10	14.49	3	20807	13	64477909
Dysmenorrhoea	16.00	14.49	10	20800	2487	64475435
Uterine infection	15.88	14.49	5	20805	237	64477685
Tongue oedema	15.66	14.49	14	20796	5976	64471946
Uterine cervical laceration	15.43	14.49	3	20807	17	64477905
Gastrointestinal disorder	15.18	14.49	5	20805	89704	64388218
Hospitalisation	15.01	14.49	3	20807	75204	64402718
Lower respiratory tract infection	14.78	14.49	6	20804	94608	64383314
Fall	14.63	14.49	77	20733	416749	64061173
Genital haemorrhage	14.62	14.49	13	20797	5509	64472413

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
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
FDA EPC	N0000175785	Prostaglandin E1 Analog
CHEBI has role	CHEBI:36063	oxytocic agents
CHEBI has role	CHEBI:49201	anti-ulcer drugs
CHEBI has role	CHEBI:50691	abortifacient drug
MeSH PA	D000019	Abortifacient Agents
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

Drug Use (View source of the data)

Disease	Relation	SNOMED_ID	DOID
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:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Bioact source	MoA source
Prostaglandin E2 receptor EP3 subtype	GPCR	P43115	PE2R3_HUMAN	AGONIST	Ki	8.10	IUPHAR	CHEMBL
Prostaglandin E2 receptor EP2 subtype	GPCR	P43116	PE2R2_HUMAN	AGONIST	Ki	7.50	IUPHAR
Prostaglandin E2 receptor EP4 subtype	GPCR	P35408	PE2R4_HUMAN	AGONIST	Ki	7.60	IUPHAR
Prostaglandin F2-alpha receptor	GPCR	P43088	PF2R_HUMAN		Ki	5.03	PDSP

External reference:

ID	Source
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
C047042	MESH_SUPPLEMENTAL_RECORD_UI
5154	INN_ID
66792-31-2	SECONDARY_CAS_RN
0E43V0BB57	UNII
6436406	PUBCHEM_CID
151578	RXNORM
44310	MMSL
445	MMSL
5121	MMSL
d00303	MMSL
001133	NDDF
387242007	SNOMEDCT_US
43684009	SNOMEDCT_US
C0377863	UMLSCUI
CHEMBL1201377	ChEMBL_ID
12Z0SU967A	UNII

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
ARTHROTEC	HUMAN PRESCRIPTION DRUG LABEL	2	0025-1411	TABLET, FILM COATED	200 ug	ORAL	NDA	30 sections
ARTHROTEC	HUMAN PRESCRIPTION DRUG LABEL	2	0025-1421	TABLET, FILM COATED	200 ug	ORAL	NDA	30 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	0904-6806	TABLET	100 ug	ORAL	ANDA	22 sections
Misoprostol	HUMAN PRESCRIPTION DRUG LABEL	1	0904-6807	TABLET	200 ug	ORAL	ANDA	22 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	43063-707	TABLET	200 ug	ORAL	ANDA	22 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