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)
Premature baby18.04.02.0010.000079%-
Premature delivery18.07.01.0060.000079%
Productive cough22.02.03.0050.000079%
Prostatic disorder21.04.01.001---
Pruritus23.03.12.0010.000928%
Pulmonary embolism22.06.02.001; 24.01.06.0010.000316%-
Pulmonary infarction22.06.02.002; 24.04.09.0010.000039%-
Pyrexia08.05.02.0030.000403%
Rash23.03.13.0010.000652%-
Rash erythematous23.03.13.0290.000178%-
Rash maculo-papular23.03.13.0040.000039%
Rash papular23.03.13.0170.000099%-
Rash pruritic23.03.13.0300.000197%-
Rectal haemorrhage07.12.03.001; 24.07.02.018--
Refraction disorder06.02.04.004---
Renal failure20.01.03.005---
Renal tubular disorder20.05.03.0040.000039%-
Respiratory disorder22.02.07.002---
Respiratory distress22.02.01.0120.000039%-
Rhabdomyolysis15.05.05.0020.000415%
Rhinitis11.01.13.004; 22.07.03.006--
Sinusitis11.01.13.005; 22.07.03.007--
Skin discolouration23.03.03.0050.000039%-
Skin disorder23.03.03.007---
Skin exfoliation23.03.07.0030.000039%-
Skin hyperpigmentation23.05.01.0030.000039%
Skin ulcer23.07.03.003; 24.04.03.007--
Somnolence17.02.04.006; 19.02.05.003--
Swelling08.01.03.0150.000107%-
Tachycardia02.03.02.007---
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ADReCS-Target
Drug Name ADR Term Target
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