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 approved
ATC Code R03DX07
DrugBank ID DB01656
KEGG ID D05744
MeSH ID C424423
PubChem ID 449193
TTD Drug ID D0R4UW
NDC Product Code 47234-0095; 64552-4096; 65015-850; 65977-0111; 42571-259; 42571-369; 70771-1673; 70771-1674; 80610-130; 43547-005; 59651-275; 43265-7462; 64552-4067; 0378-1905; 59651-222; 31722-623; 0310-0088; 14501-0078; 47234-0088; 72205-200; 43265-7463; 0310-0095; 64380-786; 68382-624; 54245-7016; 82245-0118; 64552-4053; 31722-676; 68382-969; 72205-201; 13668-476
UNII 0P6C6ZOP5U
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
SMILES C1CC1COC2=C(C=CC(=C2)C(=O)NC3=C(C=NC=C3Cl)Cl)OC(F)F
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)
Abdominal discomfort07.01.06.0010.003139%Not Available
Abdominal pain07.01.05.0020.013079%
Abdominal pain upper07.01.05.0030.004185%
Abnormal dreams19.02.03.001; 17.15.02.0010.009417%Not Available
Acute myocardial infarction24.04.04.001; 02.02.02.0010.001046%Not Available
Agitation19.06.02.001; 17.02.05.0120.005859%
Anaphylactic reaction24.06.03.006; 10.01.07.0010.001046%
Anger19.04.02.0010.002302%Not Available
Angioedema22.04.02.008; 23.04.01.001; 10.01.05.009--Not Available
Anxiety19.06.02.0020.019462%
Application site pain12.07.01.004; 08.02.01.0040.003558%Not Available
Arrhythmia02.03.02.0010.004604%Not Available
Asthenia08.01.01.0010.016741%Not Available
Asthma22.03.01.002; 10.01.03.0100.001046%Not Available
Atrial fibrillation02.03.03.0020.008789%
Atrioventricular block02.03.01.0020.001046%Not Available
Back pain15.03.04.0050.009522%
Breast cancer21.05.01.003; 16.10.01.0010.002093%Not Available
Bronchiectasis22.03.02.0050.003348%Not Available
Bronchospasm22.03.01.004; 10.01.03.0120.001046%
Cardiac failure02.05.01.0010.002093%
Chest pain22.12.02.003; 08.01.08.002; 02.02.02.0110.005964%Not Available
Chills15.05.03.016; 08.01.09.0010.002825%
Chronic obstructive pulmonary disease22.03.01.0070.028565%Not Available
Colitis07.08.01.0010.001046%
Completed suicide19.12.01.001; 08.04.01.0100.002093%Not Available
Condition aggravated08.01.03.0040.005755%Not Available
Constipation07.02.02.001--
Cough22.02.03.0010.013079%
Crying19.04.02.002; 17.02.05.013; 12.02.11.001; 08.01.03.0050.004081%Not Available
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