Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Salsalate
Drug ID BADD_D01983
Description Salsalate is a nonsteroidal anti-inflammatory agent for oral administration. Salsalate's mode of action as an anti-inflammatory and antirheumatic agent may be due to inhibition of synthesis and release of prostaglandins. The usefulness of salicylic acid, the active in vivo product of salsalate, in the treatment of arthritic disorders has been established. In contrast to aspirin, salsalate causes no greater fecal gastrointestinal blood loss than placebo. Salsalate is readily soluble in the small intestine where it is partially hydrolyzed to two molecules of salicylic acid. A significant portion of the parent compound is absorbed unchanged and undergoes rapid esterase hydrolysis in the body. The parent compound has an elimination half-life of about 1 hour. Salicylic acid (the active metabolite) biotransformation is saturated at anti-inflammatory doses of salsalate. Such capacity limited biotransformation results in an increase in the half-life of salicylic acid from 3.5 to 16 or more hours.
Indications and Usage For relief of the signs and symptoms of rheumatoid arthritis, osteoarthritis and related rheumatic disorders.
Marketing Status approved
ATC Code N02BA06
DrugBank ID DB01399
KEGG ID D00428
MeSH ID C014182
PubChem ID 5161
TTD Drug ID D0Y0JH
NDC Product Code 47621-001; 42192-366; 71205-983; 51293-615; 63629-9248; 69367-160; 65162-512; 42192-365; 65162-513; 63629-8997; 72162-1569; 62350-0075; 72761-027; 63629-8416; 71205-982; 63629-2150; 63629-9247; 58793-003; 51293-616; 69367-161
UNII V9MO595C9I
Synonyms salicylsalicylic acid | benzoic acid, 2-hydroxy-, 2-carboxyphenyl ester | disalicylic acid | salsalate | Argesic | Disalcid | Salsitab | Salflex | salicyl salicylate | Saloxium | Arcylate | Mono-Gesic
Chemical Information
Molecular Formula C14H10O5
CAS Registry Number 552-94-3
SMILES C1=CC=C(C(=C1)C(=O)OC2=CC=CC=C2C(=O)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)
Abdominal pain07.01.05.002--
Anaphylactic shock10.01.07.002; 24.06.02.004---
Angioedema10.01.05.009; 22.04.02.008; 23.04.01.001---
Blood creatinine decreased13.13.01.003---
Bronchospasm10.01.03.012; 22.03.01.004--
Creatinine renal clearance decreased13.13.01.013---
Deafness04.02.01.001---
Dermatitis23.03.04.002---
Diarrhoea07.02.01.001--
Gastrointestinal haemorrhage07.12.02.001; 24.07.02.009---
Gastrointestinal pain07.01.05.005--
Haemoglobin13.01.05.018---
Hepatic function abnormal09.01.02.001---
Hepatitis09.01.07.004---
Hypotension24.06.03.002--
Nausea07.01.07.001--
Nephritis20.05.02.001---
Rash23.03.13.001---
Tinnitus04.04.01.002; 17.04.07.004--
Urticaria10.01.06.001; 23.04.02.001--
Vertigo04.04.01.003; 17.02.12.002--
Hypoacusis04.02.01.006--
Haemorrhage24.07.01.002---
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