Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Fenofibrate
Drug ID BADD_D00873
Description Fenofibrate is a fibric acid derivative like [clofibrate] and [gemfibrozil].[A185954] Fenofibrate is used to treat primary hypercholesterolemia, mixed dyslipidemia, severe hypertriglyceridemia.[L8588,L8591] Fenofibrate was granted FDA approval on 31 December 1993.[L8585]
Indications and Usage Fenofibrate is indicated as adjunctive therapy to diet to reduce elevated LDL-C, Total-C, Triglycerides, and Apo B, and to increase HDL-C adults with primary hypercholesterolemia or mixed dyslipidemia.[L8588,L8591] Fenofibrate is also indicated to treat adults with severe hypertriglyceridemia.[L8588,L8591]
Marketing Status approved
ATC Code C10AB05
DrugBank ID DB01039
KEGG ID D00565
MeSH ID D011345
PubChem ID 3339
TTD Drug ID D07XGR
NDC Product Code 11014-0132; 11722-065; 17337-0019; 58175-0348; 0074-3173; 13668-439; 31722-595; 0115-5522; 42385-950; 50090-6227; 51079-599; 55111-349; 60505-3121; 60687-629; 60760-318; 62332-361; 62332-538; 63304-444; 68180-131; 68180-231; 68462-580; 68462-582; 69238-1263; 71205-050; 71205-190; 71205-666; 71205-949; 0904-7161; 66064-1006; 16714-740; 27437-109; 0115-0522; 0115-5511; 42385-951; 42858-200; 43547-431; 50090-3044; 63304-448; 68071-1712; 70518-2768; 71335-1701; 72789-310; 13668-440; 46708-085; 51407-092; 51407-204; 51655-234; 59651-203; 60687-666; 63187-640; 63304-901; 0378-7100; 68180-389; 68788-8106; 69844-008; 71335-1286; 71335-1292; 71335-2016; 59651-576; 60219-5522; 62332-086; 62332-554; 62559-305; 63187-940; 63304-449; 0378-4391; 68462-581; 69097-894; 69238-1261; 69367-270; 70756-214; 71205-366; 71335-0741; 71335-0891; 82009-060; 11014-0131; 17337-0410; 27437-110; 35561-345; 42291-289; 42385-936; 42858-454; 42858-660; 43975-306; 46708-555; 51407-205; 59651-201; 60687-713; 62332-084; 63187-681; 0378-3066; 68071-2587; 68180-746; 68682-490; 69238-1260; 69315-290; 69367-254; 69844-013; 46708-084; 46708-361; 46708-554; 50268-312; 50268-338; 55700-876; 60219-5511; 60687-655; 62332-360; 62559-461; 68071-2812; 68788-7816; 69097-458; 69367-269; 69844-009; 70518-2349; 0615-8270; 65862-768; 68294-0001; 16714-741; 27241-120; 31722-596; 35561-346; 0115-0511; 42385-935; 42858-067; 46708-086; 46708-350; 46708-360; 50090-6120; 51407-094; 51655-433; 51655-856; 62332-539; 63304-443; 63629-1100; 63629-1101; 63629-9474; 0378-4390; 65862-769; 68071-2540; 68071-2686; 68788-7932; 69097-895; 69844-012; 17337-0430; 0904-7128; 59349-0018; 65977-0074; 16714-739; 35561-347; 0115-0533; 42291-427; 43353-001; 43353-272; 50090-1275; 50090-4698; 50090-5854; 51079-608; 59651-202; 62559-306; 63187-760; 63304-900; 0378-7101; 68012-490; 68084-328; 68180-232; 68180-388; 69315-288; 70934-977; 13672-020; 53747-033; 70966-0021; 13668-438; 27241-117; 27437-108; 42291-290; 43975-305; 43975-444; 51407-091; 60505-3120; 60687-618; 62332-085; 62332-351; 62559-460; 63629-7213; 0378-3065; 68084-827; 68180-130; 69097-896; 69315-287; 69367-268; 70518-2907; 70518-2947; 70518-3370; 71335-0872; 71610-027; 0074-3189; 27241-116; 27241-119; 43353-898; 43598-910; 50090-5244; 51407-090; 55111-395; 62332-350; 62332-555; 63629-1099; 63629-2505; 68012-495; 68084-329; 68682-495; 69097-459; 69238-1262; 69315-289; 70756-215; 71335-1756; 49452-3101; 68543-3173; 68543-3189; 27241-118; 42858-134; 43547-430; 43598-909; 46708-351; 50090-2899; 50090-5796; 50268-313; 51407-093; 51655-009; 51655-554; 59651-575
UNII U202363UOS
Synonyms Fenofibrate | Phenofibrate | Procetofene | Procetofen | Apo-Feno-Micro | Apo Feno Micro | Apo-Fenofibrate | Apo Fenofibrate | CiL | Controlip | durafenat | Fenobeta | Fenofanton | Fenofibrat AbZ | Fenofibrat AL | Fenofibrat AZU | AZU, Fenofibrat | Fenofibrat Heumann | Heumann, Fenofibrat | Fenofibrat Hexal | Hexal, Fenofibrat | Fenofibrat Stada | Stada, Fenofibrat | fenofibrat von ct | Fenofibrat-ratiopharm | Fenofibrat ratiopharm | Fénofibrate MSD | Gen-Fenofibrate | Gen Fenofibrate | LF-178 | LF 178 | LF178 | Lipanthyl | Lipantil | Fenofibrat FPh | Lipidil | Secalip | Supralip | Fénofibrate Debat | Debat, Fénofibrate | Lipidil-Ter | Lipidil Ter | Liparison | Livesan | Lofibra | MTW-Fenofibrat | MTW Fenofibrat | Novo-Fenofibrate | Novo Fenofibrate | Nu-Fenofibrate | Nu Fenofibrate | PMS-Fenofibrate Micro | PMS Fenofibrate Micro | Tricor | Normalip | Antara Micronized Procetofen | Micronized Procetofen, Antara | Procetofen, Antara Micronized
Chemical Information
Molecular Formula C20H21ClO4
CAS Registry Number 49562-28-9
SMILES CC(C)OC(=O)C(C)(C)OC1=CC=C(C=C1)C(=O)C2=CC=C(C=C2)Cl
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)
Cholestatic liver injury09.01.07.0160.000237%-
Hypertransaminasaemia09.01.02.0050.000039%-
Acute kidney injury20.01.03.0160.000553%
Drug-induced liver injury09.01.07.023; 12.03.01.0440.001046%-
Drug reaction with eosinophilia and systemic symptoms10.01.01.021; 12.03.01.064; 23.03.05.0050.000217%-
Multiple organ dysfunction syndrome08.01.03.0570.000118%
Liver function test increased13.03.04.031---
Palatal oedema07.05.04.0080.000039%-
Hypercreatinaemia14.11.01.024; 15.05.03.0210.000039%-
Skin plaque23.03.03.0440.000039%-
Diabetic metabolic decompensation05.07.03.003; 14.07.03.0030.000039%-
Steatohepatitis09.01.07.024; 14.08.04.0200.000039%-
Hypersensitivity pneumonitis10.01.03.056; 22.01.01.027---
Immune thrombocytopenia01.08.01.013; 10.02.01.0830.000059%-
Placental transfusion syndrome01.05.01.031; 18.05.02.0100.000039%-
Subacute kidney injury20.01.03.0300.000099%-
Therapy non-responder08.06.01.0630.000280%-
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ADReCS-Target
Drug Name ADR Term Target
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