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)
Abdominal discomfort07.01.06.0010.038880%Not Available
Abdominal distension07.01.04.001--
Abdominal pain07.01.05.0020.051840%
Abdominal pain lower07.01.05.010--Not Available
Abdominal pain upper07.01.05.0030.051840%
Abortion spontaneous18.01.04.0010.038880%Not Available
Acne23.02.01.001--Not Available
Acute hepatic failure09.01.03.0010.027047%Not Available
Alopecia23.02.02.0010.025920%
Amenorrhoea21.01.02.001; 05.05.01.002--
Anaemia01.03.02.0010.051840%
Anaphylactic reaction24.06.03.006; 10.01.07.001--
Anaphylactic shock24.06.02.004; 10.01.07.0020.025920%Not Available
Angioedema23.04.01.001; 10.01.05.009--Not Available
Anxiety19.06.02.002--
Arthritis15.01.01.001--
Arthropathy15.01.01.003--Not Available
Arthropod bite12.01.08.022--Not Available
Asthenia08.01.01.0010.038880%Not Available
Asthma22.03.01.002; 10.01.03.010--Not Available
Autoimmune hepatitis10.04.09.001; 09.01.07.0190.025920%Not Available
Back pain15.03.04.0050.025920%
Biliary colic09.02.01.001--Not Available
Blister23.03.01.001; 12.01.06.0020.038880%Not Available
Blood bilirubin increased13.03.01.0080.025920%
Body temperature increased13.15.01.001--Not Available
Bronchospasm22.03.01.004; 10.01.03.012--
Cardiovascular disorder24.03.02.009; 02.01.01.001--Not Available
Chest pain08.01.08.002; 02.02.02.011; 22.02.08.003--Not Available
Cholecystitis09.03.01.001--
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