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 indicated as a tablet to reduce the risk of NSAID induced gastric ulcers but not duodenal ulcers in high risk patients.[L7616] Misoprostol is also formulated in combination with diclofenac to treat symptoms of osteoarthritis or rheumatoid arthritis in patients with a high risk of developing gastric ulcers.[L7619] Misoprostol is used off label for the management of miscarriages, prevention of post partum hemorrhage, and is also used alone or in combination with mifepristone in other countries for first trimester abortions.[A181589,A181583,A181697]
Marketing Status approved
ATC Code A02BB01; G02AD06
DrugBank ID DB00929
KEGG ID D00419
MeSH ID D016595
PubChem ID 5282381
TTD Drug ID D09ANG
NDC Product Code 24584-1051; 10135-745; 60592-234; 43393-023; 60687-746; 71335-0460; 72789-128; 43063-707; 59762-5008; 60687-735; 70954-443; 65035-103; 0025-1461; 71335-9631; 63629-7929; 38779-2778; 40032-161; 42571-254; 43393-020; 43393-022; 63704-008; 68084-040; 72789-121; 68245-0001; 59762-5007; 68084-041; 43386-160; 43386-161; 0025-1451; 42571-253; 54348-148; 68071-2904; 70954-444; 72789-300; 40016-002; 10135-746; 40032-160; 72789-111
UNII 0E43V0BB57
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
ADRs Induced by Drug
*The priority for ADR severity classification is based on FAERS assessment, followed by the most severe level in CTCAE rating. If neither is available, it will be displayed as 'Not available'.
**The 'Not Available' level is hidden by default and can be restored by clicking on the legend twice.
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Vulvovaginal erythema21.08.02.011; 23.03.06.0170.000617%-
Foetal growth restriction18.03.01.0020.000925%
Myocardial necrosis marker increased13.04.01.013---
Neonatal asphyxia18.04.15.005; 22.11.02.0060.001233%-
Neonatal respiratory distress syndrome18.04.10.003; 22.11.02.0100.000925%-
Normal newborn18.08.06.0010.002404%-
Obstructed labour18.07.01.0080.000925%-
Post abortion haemorrhage18.01.03.004; 24.07.03.0270.004932%-
Retained products of conception12.02.14.006; 18.01.03.0060.001233%-
Speech disorder developmental17.02.08.011; 19.19.01.0030.000617%-
Ruptured ectopic pregnancy18.02.02.0050.000925%-
Cerebral ventricle dilatation17.11.01.0130.000925%-
Meconium in amniotic fluid18.05.01.0070.000925%-
Foetal heart rate disorder02.03.02.025; 18.03.02.0140.000925%-
Stress cardiomyopathy02.04.01.012; 24.04.04.0260.001233%-
Blood loss anaemia01.03.02.018; 24.07.01.0880.002466%-
Drug effective for unapproved indication08.06.01.037; 12.09.02.0010.001356%-
Drug ineffective for unapproved indication08.06.01.038; 12.09.02.0020.051911%-
Female reproductive tract disorder21.10.05.020---
Haemoperitoneum07.07.02.007; 12.01.17.007; 24.07.02.0650.001541%-
Heavy menstrual bleeding21.01.03.005---
Hypoxic ischaemic encephalopathy neonatal17.13.02.016; 18.04.04.017; 22.02.02.016; 24.04.06.0480.000617%-
Intermenstrual bleeding21.01.01.0150.012454%-
Neonatal seizure17.12.03.038; 18.04.04.0190.001233%-
Orbital apex syndrome06.05.02.029; 17.04.01.0060.000617%-
Precipitate labour18.07.01.0100.000617%-
Uterine tachysystole18.07.02.013; 21.07.03.0070.001541%-
The 8th Page    First    Pre   8    Total 8 Pages
ADReCS-Target
Drug Name ADR Term Target
Tip:  Drug Name  ADR Term  Protein  Variation  Gene