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 Orlistat is indicated for obesity management including weight loss and weight maintenance when used in combination with calorie reduction in overweight and obese adults; this indication applies to both the prescription formulation of 120 mg[L11130] and the over the counter formulation of 60 mg.[L31963] Orlistat in the 120 mg prescription formulation is also indicated to reduce the risk for weight regain following weight loss.[L11130]
Marketing Status approved; investigational
ATC Code A08AB01
DrugBank ID DB01083
KEGG ID D04028
MeSH ID D000077403
PubChem ID 3034010
TTD Drug ID D0T9TJ
NDC Product Code 61269-565; 66499-0043; 0135-0461; 71052-110; 61269-460; 42677-119; 62331-045
UNII 95M8R751W8
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
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)
Abdominal discomfort07.01.06.0010.015269%-
Abdominal distension07.01.04.0010.041284%
Abdominal pain07.01.05.0020.039022%
Abdominal pain lower07.01.05.010---
Abdominal pain upper07.01.05.0030.025449%
Abnormal faeces07.01.03.0010.020925%-
Abortion spontaneous18.01.04.0010.008483%-
Acne23.02.01.001---
Acute hepatic failure09.01.03.0010.025449%-
Alopecia23.02.02.0010.015269%
Amenorrhoea21.01.02.001; 05.05.01.002--
Anaemia01.03.02.0010.014138%
Anaphylactic reaction24.06.03.006; 10.01.07.001--
Anaphylactic shock24.06.02.004; 10.01.07.0020.005655%-
Angioedema23.04.01.001; 10.01.05.009; 22.04.02.008---
Anxiety19.06.02.0020.011311%
Arthralgia15.01.02.0010.024883%
Arthritis15.01.01.001--
Arthropathy15.01.01.003---
Arthropod bite12.01.08.022---
Asthenia08.01.01.0010.023752%-
Asthma22.03.01.002; 10.01.03.0100.005655%-
Atrial fibrillation02.03.03.002--
Autoimmune hepatitis10.04.09.001; 09.01.07.0190.005655%-
Back pain15.03.04.0050.030539%
Biliary colic09.02.01.001---
Blister23.03.01.001; 12.01.06.0020.015269%-
Body temperature increased13.15.01.001---
Bronchospasm22.03.01.004; 10.01.03.012--
Cardiovascular disorder02.11.01.010; 24.03.02.009---
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