Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Misoprostol
Drug ID BADD_D01477
Description Misoprostol is a prostaglandin analog used to reduce the risk of NSAID related ulcers, manage miscarriages, prevent post partum hemorrhage, and also for first trimester abortions.[L7616,L7619,A181589,A181583,A181697] The stimulation of prostaglandin receptors in the stomach reduces gastric acid secretion, while stimulating these receptors in the uterus and cervix can increase the strength and frequency of contractions and decrease cervical tone.[A181586] Misoprostol was granted FDA approval on 27 December 1988.[L7616]
Indications and Usage Misoprostol is also indicated for other uses that are not approved in Canada, including the medical termination of an intrauterine pregnancy used alone or in combination with methotrexate,as well as the induction of labour in a selected population of pregnant women with unfavourable cervices. This indication is avoided in women with prior uterine surgery or cesarean surgery due to an increased risk of possible uterine rupture. Misoprostol is also used for the prevention or treatment of serious postpartum hemorrhage.
Marketing Status Prescription
ATC Code A02BB01; G02AD06
DrugBank ID DB00929
KEGG ID D00419
MeSH ID D016595
PubChem ID 5282381
TTD Drug ID D09ANG
NDC Product Code 59762-5007; 0025-1451; 55289-248; 38779-2778; 43393-022; 70710-1006; 0904-6806; 40032-160; 0025-1461; 43063-707; 54348-148; 60592-234; 72789-121; 71335-0460; 70954-443; 72789-111; 72789-128; 40016-002; 43393-020; 40032-161; 70954-444; 65035-103; 43386-161; 68071-4843; 0904-6807; 70771-1496; 59762-5008; 68084-041; 63704-008; 24584-1051; 70710-1007; 63629-7929; 68245-0001; 70771-1497; 12634-502; 68084-040; 43386-160
Synonyms Misoprostol | Novo-Misoprostol | Novo Misoprostol | SC-29333 | SC 29333 | SC29333 | SC-30249 | SC 30249 | SC30249 | Apo-Misoprostol | Apo Misoprostol | Misoprostol, (11beta,13E,16R)-Isomer | Glefos | Misoprostol, (11alpha,13E)-Isomer | Misoprostol, (11alpha,13E,16R)-Isomer | Misoprostol, (11alpha,13Z)-(+-)-Isomer | Misoprostol, (11alpha.13E,16S)-Isomer | Misoprostol, (11beta,13E)-(+-)-Isomer | Misoprostol, (11beta,13E,16S)-Isomer | Cytotec
Chemical Information
Molecular Formula C22H38O5
CAS Registry Number 59122-46-2
SMILES CCCCC(C)(CC=CC1C(CC(=O)C1CCCCCCC(=O)OC)O)O
Chemical Structure
ADR Related Proteins Induced by Drug
ADR Term Protein Name UniProt AC TTD Target ID PMID
Not AvailableNot AvailableNot AvailableNot AvailableNot Available
ADRs Induced by Drug
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Breast pain21.05.05.003--
Bronchitis22.07.01.001; 11.01.09.001--
Bronchospasm22.03.01.004; 10.01.03.012--
Cardiac arrest02.03.04.0010.002580%
Cardio-respiratory arrest02.03.04.002; 22.02.06.0070.002826%Not Available
Cerebral palsy18.04.04.004; 17.19.03.002; 03.10.03.0020.002826%Not Available
Cerebrovascular accident24.03.05.001; 17.08.01.007--
Chest pain22.02.08.003; 08.01.08.002; 02.02.02.011--Not Available
Chills15.05.03.016; 08.01.09.0010.015541%
Circulatory collapse24.06.02.0010.002949%Not Available
Cleft palate07.05.08.001; 03.04.02.0010.004239%Not Available
Coagulopathy01.01.02.0010.002826%Not Available
Confusional state19.13.01.001; 17.02.03.005--
Congenital anomaly03.02.01.001--Not Available
Congenital central nervous system anomaly03.10.02.004; 17.19.01.0030.002826%Not Available
Conjunctivitis11.01.06.012; 06.04.01.002--
Constipation07.02.02.001--
Convulsion neonatal18.04.04.003; 17.12.03.0170.005651%Not Available
Cough22.02.03.001--
Deafness04.02.01.001--Not Available
Death08.04.01.001--
Death neonatal18.04.01.002; 08.04.01.0020.000737%
Dehydration14.05.05.001--
Depressed level of consciousness17.02.04.0020.004239%
Depression19.15.01.001--
Dermatitis23.03.04.002--Not Available
Developmental delay08.01.03.0370.002826%Not Available
Diarrhoea07.02.01.001--
Differential white blood cell count abnormal13.01.06.017--Not Available
Disseminated intravascular coagulation24.01.01.010; 01.01.02.0020.001843%
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