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
TTD Drug ID D0R4UW
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
SMILES C1CC1COC2=C(C=CC(=C2)C(=O)NC3=C(C=NC=C3Cl)Cl)OC(F)F
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)
Rhinorrhoea22.02.05.0100.004796%
Sinus tachycardia02.03.03.0100.004796%
Sinusitis22.07.03.007; 11.01.13.005--
Skin disorder23.03.03.007--Not Available
Sleep apnoea syndrome19.02.05.002; 17.15.05.001; 22.02.01.0130.004796%
Sleep disorder19.02.04.0010.009591%Not Available
Somnolence19.02.05.003; 17.02.04.006--
Suicidal ideation19.12.01.0030.083925%
Suicide attempt19.12.01.0040.021581%
Syncope02.01.02.008; 24.06.02.012; 17.02.04.008--
Tachycardia02.03.02.0070.011989%Not Available
Tension19.06.02.005--Not Available
Thrombosis24.01.01.006--Not Available
Tremor17.01.06.0020.062344%
Urinary tract infection11.01.14.004; 20.08.02.001--
Urticaria23.04.02.001; 10.01.06.001--
Vaginal haemorrhage21.08.01.001; 24.07.03.0050.004796%
Vasculitis24.05.02.001; 10.02.02.0060.004796%
Ventricular tachycardia02.03.04.0100.007194%
Vertigo17.02.12.002; 04.04.01.003--
Vision blurred17.17.01.010; 06.02.06.007--
Vomiting07.01.07.003--
Weight decreased13.15.01.0050.151065%
Wheezing22.03.01.0090.004796%
Mental status changes19.07.01.0010.004796%Not Available
Food aversion19.09.01.0110.004796%Not Available
Abasia17.02.05.035; 08.01.02.0070.004796%Not Available
Sputum purulent22.02.03.008; 11.01.09.0090.004796%Not Available
Lower gastrointestinal haemorrhage24.07.02.030; 07.12.02.0070.007194%
Haemodynamic instability24.03.02.0060.004796%Not Available
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