Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Pirfenidone
Drug ID BADD_D01783
Description Pirfenidone is an orally active small molecule drug that may inhibit collagen synthesis, down regulate production of multiple cytokines and block fibroblast proliferation and stimulation in response to cytokines. Pirfenidone has demonstrated activity in multiple fibrotic conditions, including those of the lung, kidney and liver. It is being investigated by InterMune.
Indications and Usage For the treatment of idiopathic pulmonary fibrosis (IPF).
Marketing Status approved; investigational
ATC Code L04AX05
DrugBank ID DB04951
KEGG ID D01583
MeSH ID C093844
PubChem ID 40632
TTD Drug ID D02WCI
NDC Product Code 0480-3610; 60862-005; 69766-030; 76072-1006; 42385-924; 69539-120; 42385-923; 42385-925; 42571-336; 69097-940; 72205-182; 0781-8085; 0480-3611; 65372-1197; 82920-705; 16729-468; 46708-479; 69238-1640; 62332-480; 0781-2158; 62207-004; 31722-872; 50228-442; 69539-119; 57297-140; 73309-052; 46708-480; 69097-988; 69238-1641; 42571-329; 46016-5312; 31722-873; 72205-181; 76282-716; 0781-8086; 53104-7712; 69037-0013; 60219-1640; 60219-1641; 47621-311; 59285-013; 59651-199; 50228-443; 50242-121; 60219-1642; 62332-479; 46016-5310; 16729-467; 42385-926; 42571-335; 50228-441; 50242-122; 69097-987; 76282-715; 76282-717; 11014-0214; 46438-0648; 62512-0070; 50242-123
UNII D7NLD2JX7U
Synonyms pirfenidone | 5-methyl-1-phenyl-2-(1H)-pyridone | Esbriet | deupirfenidone | 1-phenyl-5-(trideuteriomethyl)-1,2-dihydropyridin-2-one | Deskar
Chemical Information
Molecular Formula C12H11NO
CAS Registry Number 53179-13-8
SMILES CC1=CN(C(=O)C=C1)C2=CC=CC=C2
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)
Fibrosis08.03.01.0010.000772%-
Flatulence07.01.04.0020.004171%
Food poisoning07.11.01.007; 11.07.02.001; 12.03.01.0240.000530%-
Frequent bowel movements07.02.04.0020.001013%-
Gamma-glutamyltransferase increased13.03.04.024--
Gastritis07.08.02.0010.001374%
Gastrooesophageal reflux disease07.02.02.0030.011549%
Gastrointestinal disorder07.11.01.0010.034720%-
Gastrointestinal pain07.01.05.0050.001591%
Gout14.09.01.001; 15.01.06.001---
Guillain-Barre syndrome10.04.10.005; 11.07.01.001; 17.09.01.0010.000241%
Haemoptysis02.11.04.009; 22.02.03.004; 24.07.01.0060.003641%-
Head discomfort17.02.05.0270.001350%-
Headache17.14.01.001--
Hepatic cirrhosis09.01.04.001---
Hepatic failure09.01.03.002--
Hepatic neoplasm09.04.03.001; 16.07.03.0010.000241%-
Hepatitis09.01.07.0040.001447%-
Hepatitis acute09.01.07.0050.000723%-
Hepatotoxicity09.01.07.009; 12.03.01.0080.003737%-
Hernia08.01.04.0010.000362%-
Hiatus hernia07.16.01.001; 22.09.02.0040.001254%-
Hyperaesthesia17.02.06.004; 23.03.03.0800.000651%-
Hyperchlorhydria07.11.03.0010.000820%-
Hyperkeratosis23.01.01.0010.000530%
Hypersomnia17.15.01.001; 19.02.05.0010.003231%
Hyperventilation19.01.02.004; 22.02.01.0060.000241%-
Hypocoagulable state01.01.02.0040.000241%-
Hypogeusia07.14.03.002; 17.02.07.0040.000530%-
Hypopnoea22.02.01.0210.000241%-
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