Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Roflumilast
Drug ID BADD_D01962
Description Roflumilast is a phosphodiesterase-4 (PDE-4) inhibitor. Due to its selective inhibition of the PDE4 isoenzyme in lung cells, roflumilast is indicated for the management of chronic obstrtuctive pulmonary disease (COPD) exacerbations. Treatment with Roflumilast is associated with an increase in psychiatric adverse reactions, including suicide and suicidal attempts.
Indications and Usage Roflumilast is indicated as a treatment to reduce the risk of COPD exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations. Roflumilast is not a bronchodilator and is not indicated for the relief of acute bronchospasm.
Marketing Status Prescription
ATC Code R03DX07
DrugBank ID DB01656
KEGG ID D05744
MeSH ID C424423
PubChem ID 449193
NDC Product Code 43265-7463; 47234-0088; 64552-4053; 54245-7016; 65977-0111; 82245-0118; 43265-7462; 0310-0088; 0310-0095; 47234-0095; 14501-0078; 65015-850; 59651-222
Synonyms Roflumilast | 3-cyclopropylmethoxy-4-difluoromethoxy-N-(3,5-di-chloropyrid-4-yl)benzamide | daliresp
Chemical Information
Molecular Formula C17H14Cl2F2N2O3
CAS Registry Number 162401-32-3
Chemical Structure
ADR Related Proteins Induced by Drug
ADR Term Protein Name UniProt AC TTD Target ID PMID
Not AvailableNot AvailableNot AvailableNot AvailableNot Available
ADRs Induced by Drug
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Abdominal discomfort07.01.06.001--Not Available
Abdominal distension07.01.04.001--
Abdominal pain07.01.05.0020.033570%
Abdominal pain upper07.01.05.0030.016785%
Abnormal dreams19.02.03.001; Available
Acute myocardial infarction24.04.04.001; Available
Anaphylactic reaction24.06.03.006;
Anger19.04.02.0010.004796%Not Available
Angioedema23.04.01.001; Available
Arrhythmia02.03.02.0010.009591%Not Available
Asthenia08.01.01.0010.047957%Not Available
Asthma22.03.01.002; Available
Atrial fibrillation02.03.03.0020.028774%
Atrioventricular block02.03.01.0020.004796%Not Available
Back pain15.03.04.0050.028774%
Blood pressure increased13.14.03.0050.009591%Not Available
Blood sodium decreased13.11.01.0120.004796%Not Available
Breast cancer21.05.01.003; Available
Cardiac arrest02.03.04.001--
Cardiac failure02.05.01.001--
Cardiac failure congestive02.05.01.002--Not Available
Cerebrovascular accident24.03.05.001;
Chest discomfort22.02.08.001;; Available
Chest pain22.02.08.003;; Available
The 1th Page    1 2 3 4 5    Next   Last    Total 6 Pages