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)
Chapped lips07.05.01.0040.000530%-
Sudden cardiac death02.03.04.016; 08.04.01.0080.000241%-
General physical health deterioration08.01.03.0180.006124%-
Muscle fatigue15.05.03.006---
Balance disorder08.01.03.081; 17.02.02.007---
Cardiac death02.03.04.015; 08.04.01.0070.000241%-
Intervertebral disc protrusion15.10.01.0040.000362%-
Lupus-like syndrome10.04.03.003; 15.06.02.004; 23.03.02.0040.000241%-
Penile discharge21.12.01.0050.000530%-
Deep vein thrombosis24.01.02.003---
Cardiopulmonary failure02.05.01.004; 22.02.06.0040.000603%-
Dyschezia07.02.03.0050.000241%-
Photodermatosis23.03.09.0040.000530%-
Exercise tolerance decreased08.01.03.0360.000362%-
Acute coronary syndrome02.02.02.015; 24.04.04.0110.000362%-
Metastases to peritoneum07.21.03.003; 16.22.02.0080.000241%-
Respiratory tract congestion22.02.07.0030.000241%-
Upper respiratory tract congestion22.12.03.0330.000530%-
Epigastric discomfort07.01.02.0040.001061%-
Musculoskeletal discomfort15.03.04.001---
Secretion discharge08.01.03.0190.001471%-
Cerebral haematoma17.08.01.014; 24.07.04.0060.000241%-
Skin burning sensation17.02.06.009; 23.03.03.021---
Cerebral disorder17.02.10.0170.000241%-
Varices oesophageal07.15.05.001; 09.01.06.009; 24.10.02.0040.000241%-
Pulmonary mass22.02.07.0040.000723%-
Cutaneous lupus erythematosus10.04.03.007; 15.06.02.007; 23.03.02.0080.000241%-
Toxic skin eruption10.01.01.008; 12.03.01.073; 23.03.05.0030.000723%-
Ocular icterus01.06.04.007; 06.08.03.009; 09.01.01.0070.000241%-
Lung neoplasm malignant16.19.02.001; 22.08.01.0010.003665%-
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