Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Lubiprostone
Drug ID BADD_D01328
Description Lubiprostone is a medication used in the management of idiopathic chronic constipation. A prostaglandin E1 derivative, lubiprostone is a bicyclic fatty acid that activates ClC-2 chloride channels located on the apical side of the gastrointestinal epithelial cells. Activation of these channels promotes the secretion of a chloride-rich fluid that soften the stool, increase gastrointestinal motility, and induce spontaneous bowel movements (SBM).
Indications and Usage For the treatment of chronic idiopathic constipation in the adult population. Also used for the treatment of irritable bowel syndrome with constipation in women who are 18 years of age or older.
Marketing Status approved; investigational
ATC Code A06AX03
DrugBank ID DB01046
KEGG ID D04790
MeSH ID D000068238
PubChem ID 157920
TTD Drug ID D00CTS
NDC Product Code 71796-041; 68245-0011; 43598-168; 51407-745; 0254-3029; 55700-963; 76397-025; 63304-352; 64764-240; 65162-841; 70771-1763; 70771-1764; 70710-1642; 10888-5124; 11014-0011; 76397-012; 51407-744; 69339-163; 72189-410; 10888-5126; 42291-476; 63304-351; 65162-842; 10370-266; 65035-132; 0480-4138; 83008-001; 11014-0010; 42291-475; 64764-080; 0480-3479; 70710-1641; 40016-014; 54893-0093; 10370-267; 43598-163; 0254-3028; 69339-162
UNII 7662KG2R6K
Synonyms Lubiprostone | Prostan-1-oic acid, 16,16-difluoro-11-hydroxy-9,15-dioxo-, (11alpha)- | RU 0211 | 0211, RU | RU0211 | RU-0211 | Amitiza | SPI 0211 | 0211, SPI | SPI0211 | SPI-0211
Chemical Information
Molecular Formula C20H32F2O5
CAS Registry Number 333963-40-9
SMILES CCCCC(C1(CCC2C(O1)CC(=O)C2CCCCCCC(=O)O)O)(F)F
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)
Abdominal discomfort07.01.06.0010.002173%Not Available
Abdominal distension07.01.04.0010.001576%
Abdominal pain07.01.05.0020.002215%
Abdominal pain upper07.01.05.0030.001875%
Abdominal rigidity07.01.05.011--Not Available
Abdominal tenderness07.01.05.004--Not Available
Alanine aminotransferase increased13.03.04.005--
Altered state of consciousness17.02.04.001; 19.07.01.0030.000852%Not Available
Anaphylactic reaction24.06.03.006; 10.01.07.0010.000426%
Anxiety19.06.02.002--
Arrhythmia02.03.02.0010.000937%Not Available
Aspartate aminotransferase increased13.03.04.011--
Asthenia08.01.01.001--Not Available
Back pain15.03.04.0050.001662%
Blood potassium decreased13.11.01.010--Not Available
Blood pressure fluctuation24.06.01.0020.000426%Not Available
Cardiac arrest02.03.04.0010.000426%
Cardiac failure02.05.01.0010.000426%
Cerebral infarction17.08.01.004; 24.04.06.0020.000426%Not Available
Chest discomfort22.12.02.002; 08.01.08.019; 02.02.02.0090.015551%Not Available
Chest pain22.12.02.003; 02.02.02.011; 08.01.08.0020.009842%Not Available
Choking22.12.03.0030.001449%Not Available
Choking sensation22.12.03.004; 19.01.02.0020.002897%Not Available
Cold sweat23.02.03.002; 08.01.03.024--Not Available
Colitis07.08.01.0010.000426%
Colitis ischaemic24.04.08.012; 07.08.01.0040.000639%Not Available
Completed suicide19.12.01.001; 08.04.01.0100.000639%Not Available
Constipation07.02.02.0010.001363%
Cough22.02.03.0010.004772%
Defaecation urgency07.02.04.0010.000937%Not Available
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