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)
Seborrhoea23.02.07.001--Not Available
Seizure17.12.03.001--
Sinusitis22.07.03.007; 11.01.13.005--
Skin disorder23.03.03.007--Not Available
Sleep disorder19.02.04.001--Not Available
Somnolence19.02.05.003; 17.02.04.0060.051840%
Steatorrhoea07.17.01.0020.025920%Not Available
Swelling face23.04.01.018; 10.01.05.0180.025920%Not Available
Tendonitis12.01.07.007; 15.07.01.003--Not Available
Thirst14.03.02.007; 08.01.09.021--Not Available
Tooth disorder07.09.05.001--Not Available
Upper respiratory tract infection22.07.03.011; 11.01.13.009--
Urethral disorder20.07.01.002--Not Available
Urinary tract disorder20.08.01.001--Not Available
Urinary tract infection20.08.02.001; 11.01.14.004--
Urticaria23.04.02.001; 10.01.06.001--
Vaginal infection21.14.02.002; 11.01.10.002--
Vaginal inflammation21.14.02.001--
Vein disorder24.03.02.015--Not Available
Vertigo17.02.12.002; 04.04.01.003--
Vision blurred17.17.01.010; 06.02.06.007--
Vomiting07.01.07.0030.064800%
Weight decreased13.15.01.0050.038880%
Weight increased13.15.01.0060.064800%
Xeroderma23.01.02.003--Not Available
Onychoclasis23.02.05.005--Not Available
Bleeding time abnormal13.01.02.021--Not Available
Lower gastrointestinal haemorrhage24.07.02.030; 07.12.02.007--
Deep vein thrombosis24.01.02.0030.006762%Not Available
Dyschezia07.02.03.005--Not Available
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