Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Sulindac
Drug ID BADD_D02097
Description Sulindac is a nonsteroidal anti-inflammatory drug (NSAID) of the arylalkanoic acid class that is marketed by Merck under the brand name Clinoril. Like other NSAIDs, it may be used in the treatment of acute or chronic inflammatory conditions. Sulindac is a prodrug, derived from sulfinylindene, that is converted _in vivo_ to an active sulfide compound by liver enzymes. There is evidence from some studies that sulindac may be associated with fewer gastrointestinal side effects than other NSAIDs, except for the cyclooxygenase-2 (COX-2) inhibitor drug class. This may be due to the sulfide metabolite undergoing enterohepatic circulation thus maintaining constant blood levels of the compound without inducing gastrointestinal effects, where the drug is excreted in the bile and then reabsorbed from the intestines. While its full mechanism of action is not fully understood, sulindac is thought to primarily mediate its action by inhibiting prostaglandin synthesis by inhibiting COX-1 and COX-2.
Indications and Usage For acute or long-term use in the relief of signs and symptoms of osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, acute painful shoulder (acute subacromial bursitis/supraspinatus tendinitis), and acute gouty arthritis.
Marketing Status approved; investigational
ATC Code M01AB02
DrugBank ID DB00605
KEGG ID D00120
MeSH ID D013467
PubChem ID 1548887
TTD Drug ID D0Z5IU
NDC Product Code 0591-5661; 17337-0541; 24658-771; 0591-5660; 24658-770; 63629-3208; 49452-7583; 42806-018; 50090-2093; 55700-682; 53489-478; 0904-6217; 53489-479; 0904-6216; 52133-0007; 55111-059; 42806-011; 71335-0413; 55289-930; 71205-648
UNII 184SNS8VUH
Synonyms Sulindac | Apo-Sulin | Apo Sulin | Arthrobid | Clinoril | Arthrocine | Klinoril | Sulindal | Chibret | Kenalin | MK-231 | MK 231 | MK231 | Novo-Sundac | Novo Sundac | Nu-Sulindac | Nu Sulindac | Aclin | Copal
Chemical Information
Molecular Formula C20H17FO3S
CAS Registry Number 38194-50-2
SMILES CC1=C(C2=C(C1=CC3=CC=C(C=C3)S(=O)C)C=CC(=C2)F)CC(=O)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)
Constipation07.02.02.001--
Crystalluria20.02.01.003---
Death08.04.01.001--
Depressed level of consciousness17.02.04.002--
Depression19.15.01.001--
Dermatitis23.03.04.002---
Dermatitis exfoliative10.01.01.004; 23.03.07.001--
Diarrhoea07.02.01.001--
Discomfort08.01.08.003---
Disseminated intravascular coagulation01.01.02.002; 24.01.01.010--
Dizziness02.11.04.006; 17.02.05.003; 24.06.02.007--
Drug hypersensitivity10.01.01.0010.005950%-
Drug ineffective08.06.01.0060.001890%-
Duodenal ulcer07.04.02.0020.000700%
Dysgeusia07.14.03.001; 17.02.07.003--
Dyspepsia07.01.02.001--
Dyspnoea02.11.05.003; 22.02.01.004--
Dysuria20.02.02.002--
Ecchymosis01.01.03.001; 23.06.01.001; 24.07.06.002---
Eosinophilia01.02.04.001--
Epistaxis22.04.03.001; 24.07.01.005--
Erythema23.03.06.001---
Erythema multiforme10.01.03.015; 23.03.01.003--
Face oedema08.01.07.003; 10.01.05.002; 23.04.01.004--
Fatigue08.01.01.002--
Feeling abnormal08.01.09.014---
Flatulence07.01.04.002--
Flushing08.01.03.025; 23.06.05.003; 24.03.01.002--
Gastric haemorrhage07.12.01.001; 24.07.02.0070.000700%
Gastritis07.08.02.001--
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