Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Orlistat
Drug ID BADD_D01624
Description The global prevalence of obesity is increasing rapidly. Obesity-related complications lead to significant personal and economic burden by reducing quality of life and increasing the cost of healthcare. In some individuals, diet and exercise are insufficient to maintain weight loss, and pharmacological or surgical intervention is required.[A229928] Orlistat is a lipase inhibitor used in the treatment of obesity that works by inhibiting fat-metabolizing enzymes. It was approved by the FDA for use in combination with a reduced-calorie diet in 1999.[L11130] This drug is a generally well-tolerated and effective weight-loss aid and is now available in both over-the-counter[L31963] and prescription preparations, depending on the dosage quantity.[L11130]
Indications and Usage For obesity management including weight loss and weight maintenance when used in conjunction with a reduced-calorie diet. Also used to reduce the risk for weight regain after prior weight loss. Use of orlistat is pending revision due to reports of liver-related adverse events.
Marketing Status Prescription; OTC
ATC Code A08AB01
DrugBank ID DB01083
KEGG ID D04028
MeSH ID D000077403
PubChem ID 3034010
TTD Drug ID D0T9TJ
NDC Product Code 62331-045; 71973-001; 51927-5020; 0135-0461; 71052-110; 66499-0043; 61269-460
Synonyms Orlistat | Tetrahydrolipstatin | THLP | Tetrahydrolipastatin | Ro-18-0647 | Ro 18 0647 | Alli | 1-((3-Hexyl-4-oxo-2-oxetanyl)methyl)dodecyl-2-formamido-4-methylvalerate | Xenical
Chemical Information
Molecular Formula C29H53NO5
CAS Registry Number 96829-58-2
SMILES CCCCCCCCCCCC(CC1C(C(=O)O1)CCCCCC)OC(=O)C(CC(C)C)NC=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)
Epilepsy17.12.03.002--Not Available
Eructation07.01.02.003--
Faeces discoloured07.01.03.0020.051840%Not Available
Faeces hard07.01.03.003--Not Available
Fatigue08.01.01.0020.077760%
Feeling abnormal08.01.09.014--Not Available
Flank pain20.02.03.006; 15.03.04.003; 08.01.08.0070.025920%
Flatulence07.01.04.0020.025920%
Fracture15.08.02.001; 12.04.02.001--
Frequent bowel movements07.02.04.002--Not Available
Gastritis07.08.02.001--
Gastrointestinal disorder07.11.01.0010.064800%Not Available
Gastrointestinal pain07.01.05.005--
Gingival bleeding24.07.02.010; 07.09.07.0010.025920%Not Available
Gingival disorder07.09.03.001--Not Available
Haematochezia24.07.02.012; 07.12.02.0030.051840%Not Available
Haemoglobin13.01.05.018--Not Available
Haemorrhoids24.10.02.002; 07.15.03.0010.025920%
Hair texture abnormal23.02.06.004--
Headache17.14.01.0010.051840%
Hepatic encephalopathy09.01.03.006; 17.13.01.0030.025920%Not Available
Hepatic failure09.01.03.0020.013524%
Hepatic necrosis09.01.07.0020.025920%
Hepatic steatosis14.08.04.005; 09.01.07.0030.025920%Not Available
Hepatitis09.01.07.0040.025920%Not Available
Hepatitis cholestatic09.01.01.0020.038880%Not Available
Hepatotoxicity12.03.01.008; 09.01.07.0090.025920%Not Available
Hyperbilirubinaemia01.06.04.003; 14.11.01.010; 09.01.01.0030.025920%Not Available
Hyperhidrosis23.02.03.004; 08.01.03.028--
Hypersensitivity10.01.03.003--
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