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)
Gastritis07.08.02.0010.004796%
Gastrooesophageal reflux disease07.02.02.003--
Gastrointestinal disorder07.11.01.0010.023979%Not Available
Gastrointestinal pain07.01.05.005--
Gynaecomastia21.05.04.003; 05.05.02.0030.007194%
Haematochezia24.07.02.012; 07.12.02.0030.007194%Not Available
Blood urine present13.13.02.0020.007194%Not Available
Hallucination19.10.02.0020.016785%
Headache17.14.01.0010.047957%
Heart rate increased13.14.04.0020.011989%Not Available
Hepatic cirrhosis09.01.04.0010.001251%Not Available
Herpes zoster23.09.03.002; 11.05.02.0030.004796%
Hypersensitivity10.01.03.0030.011989%
Hypertension24.08.02.001--
Hypoglycaemia14.06.03.001; 05.06.03.0010.004796%
Hypotension24.06.03.002--
Hypoxia22.02.02.0030.004796%
Immune system disorder10.02.01.001--Not Available
Infection11.01.08.002--Not Available
Influenza22.07.02.001; 11.05.03.001--Not Available
Influenza like illness08.01.03.0100.007194%
Insomnia19.02.01.002; 17.15.03.0020.079129%
Intentional self-injury19.12.01.002; 12.01.08.0360.004796%Not Available
Intestinal obstruction07.13.01.0020.001877%Not Available
Loss of consciousness17.02.04.004--Not Available
Malaise08.01.01.0030.062344%
Mood swings19.04.03.0010.009591%Not Available
Muscle spasms15.05.03.0040.016785%
Myalgia15.05.02.0010.011989%
Myocardial infarction24.04.04.009; 02.02.02.007--
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