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)
Hypersensitivity vasculitis23.06.02.005; 10.02.02.017; 01.01.04.008; 24.05.02.0120.038880%Not Available
Hypertension24.08.02.0010.025920%
Hypoglycaemia14.06.03.001; 05.06.03.001--
Hypokalaemia14.05.03.002--
Hypopnoea22.02.01.0210.025920%Not Available
Hypothyroidism05.02.03.001; 14.11.01.012--
Hypovitaminosis14.12.01.001--Not Available
Immune system disorder10.02.01.001--Not Available
Increased appetite14.03.01.003; 08.01.09.027--Not Available
Infection11.01.08.002--Not Available
Influenza22.07.02.001; 11.05.03.001--Not Available
Insomnia19.02.01.002; 17.15.03.002--
International normalised ratio increased13.01.02.008--
Jaundice23.03.03.030; 09.01.01.004; 01.06.04.0040.064800%Not Available
Liver disorder09.01.08.0010.025920%Not Available
Local swelling08.01.03.013--Not Available
Lower respiratory tract infection22.07.01.002; 11.01.09.002--Not Available
Malaise08.01.01.003--
Menopausal symptoms21.02.02.002--Not Available
Menstruation irregular21.01.01.005; 05.05.01.008--
Miosis17.02.11.002; 06.05.03.0030.025920%Not Available
Multiple fractures15.08.02.005; 12.04.02.009--Not Available
Muscle spasms15.05.03.0040.025920%
Myalgia15.05.02.001--
Myopathy15.05.05.0010.051840%Not Available
Nail disorder23.02.05.002--
Nausea07.01.07.0010.103681%
Neoplasm16.16.02.001--Not Available
Nephrolithiasis20.04.01.0020.010143%
Nephropathy20.05.03.0010.064800%Not Available
The 4th Page    First    Pre   4 5 6 7 8    Next   Last    Total 8 Pages