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)
Heart rate increased13.14.04.002--Not Available
Hepatic function abnormal09.01.02.0010.001875%Not Available
Hyperhidrosis23.02.03.004; 08.01.03.028--
Hypersensitivity10.01.03.0030.002386%
Hyperventilation22.02.01.006; 19.01.02.0040.000937%Not Available
Hypoaesthesia23.03.03.081; 17.02.06.0230.000639%Not Available
Hypochloraemia14.05.08.0030.000426%Not Available
Hypokalaemia14.05.03.0020.002343%
Hyponatraemia14.05.04.0020.000852%
Hypotension24.06.03.0020.000852%
Ileus07.13.01.0010.001704%
Influenza22.07.02.001; 11.05.03.001--Not Available
Intestinal dilatation07.02.02.0100.000426%Not Available
Intestinal obstruction07.13.01.0020.000852%Not Available
Intestinal perforation07.04.06.0020.000639%Not Available
Irritable bowel syndrome19.24.01.003; 07.02.04.0030.000937%Not Available
Joint swelling15.01.02.004--Not Available
Laryngeal pain22.12.03.010--
Lethargy17.02.04.003; 08.01.01.008; 19.04.04.004--
Liver disorder09.01.08.0010.000426%Not Available
Loss of consciousness17.02.04.0040.002642%Not Available
Malaise08.01.01.0030.002301%
Marasmus14.03.02.0130.000426%Not Available
Metabolic alkalosis14.01.02.0040.000426%Not Available
Movement disorder17.01.02.0100.000426%Not Available
Muscle spasms15.05.03.004--
Muscular weakness17.05.03.005; 15.05.06.0010.000426%
Musculoskeletal pain15.03.04.0070.000937%
Myalgia15.05.02.001--
Nausea07.01.07.0010.012228%
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