Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Diflunisal
Drug ID BADD_D00666
Description Diflunisal, a salicylate derivative, is a nonsteroidal anti-inflammatory agent (NSAIA) with pharmacologic actions similar to other prototypical NSAIAs. Diflunisal possesses anti-inflammatory, analgesic and antipyretic activity. Though its mechanism of action has not been clearly established, most of its actions appear to be associated with inhibition of prostaglandin synthesis via the arachidonic acid pathway. Diflunisal is used to relieve pain accompanied with inflammation and in the symptomatic treatment of rheumatoid arthritis and osteoarthritis.
Indications and Usage For symptomatic treatment of mild to moderate pain accompanied by inflammation (e.g. musculoskeletal trauma, post-dental extraction, post-episiotomy), osteoarthritis, and rheumatoid arthritis.
Marketing Status approved; investigational
ATC Code N02BA11
DrugBank ID DB00861
KEGG ID D00130
MeSH ID D004061
PubChem ID 3059
TTD Drug ID D08LFZ
NDC Product Code 14593-891; 17511-129; 42973-152; 68382-530; 14539-673; 64980-181; 15308-0811; 62135-456; 0093-9222; 70771-1083
UNII 7C546U4DEN
Synonyms Diflunisal | Dolobid | Dolocid | Dolobis | Nu-Diflunisal | Nu Diflunisal | NuDiflunisal | MK-647 | MK 647 | MK647 | Novo-Diflunisal | Novo Diflunisal | NovoDiflunisal | Apo-Diflunisal | Apo Diflunisal | ApoDiflunisal
Chemical Information
Molecular Formula C13H8F2O3
CAS Registry Number 22494-42-4
SMILES C1=CC(=C(C=C1C2=C(C=C(C=C2)F)F)C(=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)
Renal failure20.01.03.005--Not Available
Shock24.06.02.002--Not Available
Somnolence17.02.04.006; 19.02.05.003--
Stevens-Johnson syndrome10.01.01.045; 23.03.01.007; 12.03.01.014; 11.07.01.005--
Stomatitis07.05.06.005--
Syncope24.06.02.012; 17.02.04.008; 02.11.04.015--
Tension19.06.02.005--Not Available
Thrombocytopenia01.08.01.002--Not Available
Tinnitus17.04.07.004; 04.04.01.002--
Toxic epidermal necrolysis12.03.01.015; 11.07.01.006; 10.01.01.006; 23.03.01.008--
Urticaria23.04.02.001; 10.01.06.001--
Vertigo17.02.12.002; 04.04.01.003--
Vision blurred17.17.01.010; 06.02.06.007--
Visual impairment06.02.10.013--Not Available
Vomiting07.01.07.003--
Tubulointerstitial nephritis20.05.02.002--Not Available
Hypoacusis04.02.01.006--
Protein urine present13.13.02.006--Not Available
Epidermal necrosis23.03.03.035--Not Available
Decreased appetite14.03.01.005; 08.01.09.028--
Renal impairment20.01.03.010--Not Available
Drug reaction with eosinophilia and systemic symptoms12.03.01.064; 23.03.05.005; 10.01.01.021--Not Available
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