Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Apremilast
Drug ID BADD_D00156
Description Apremilast, also known as Otezla, is a phosphodiesterase 4 (PDE4) inhibitor used to treat various types of symptoms resulting from certain inflammatory autoimmune diseases. It belongs to the same drug class as [Roflumilast] and [Crisaborole].[A181244,L7495] Initially approved in 2014, it is marketed by Celgene.[L7501] In July 2019, apremilast was granted a new FDA approval for the treatment of oral ulcers associated with Behcet's disease, an autoimmune condition that causes recurrent skin, blood vessel, and central nervous system inflammation.[A181216]
Indications and Usage Apremilast is indicated for the treatment of adults with active psoriatic arthritis and adults with oral ulcers associated with Behcet's Disease. In addition, apremilast is indicated for the treatment of plaque psoriasis, of any severity, in adult patients who are candidates for phototherapy or systemic therapy.[L7501]
Marketing Status approved; investigational
ATC Code L04AA32
DrugBank ID DB05676
KEGG ID D08860
MeSH ID C505730
PubChem ID 10151715
TTD Drug ID D07ESC
NDC Product Code 55513-369; 53069-1040; 66406-0242; 82891-014; 55513-137; 59651-150; 65129-1383; 11722-062; 12658-0581; 47621-306; 53069-1050; 66406-0241; 70518-3155; 49187-0757; 55111-993; 58032-2030; 65372-1204; 69766-010; 69766-024; 55513-485; 53747-077; 65977-0119; 66039-934; 73309-043; 66406-0240
UNII UP7QBP99PN
Synonyms apremilast | Otezla | CC 10004 | CC10004 | CC-10004
Chemical Information
Molecular Formula C22H24N2O7S
CAS Registry Number 253168-86-4
SMILES CCOC1=C(C=CC(=C1)C(CS(=O)(=O)C)N2C(=O)C3=C(C2=O)C(=CC=C3)NC(=O)C)OC
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)
Diabetic complication14.07.03.002; 05.07.03.0020.000651%Not Available
Gastrointestinal motility disorder07.02.03.0010.004099%Not Available
Gastrointestinal neoplasm16.13.11.001; 07.21.04.0020.000530%Not Available
Inflammation10.02.01.089; 08.01.05.007--Not Available
Malnutrition14.03.02.004--Not Available
Mediastinal disorder22.09.03.001--Not Available
Oesophageal disorder07.11.02.0010.001181%Not Available
Spinal disorder15.02.04.0230.003159%Not Available
Cardiac valve disease02.07.02.0010.002604%Not Available
Decreased appetite14.03.01.005; 08.01.09.0280.327455%
Ill-defined disorder08.01.03.049--Not Available
Immunodeficiency10.03.02.002--Not Available
Adverse drug reaction08.06.01.0090.556174%Not Available
Food intolerance14.02.01.0050.001760%Not Available
Immunosuppression10.03.02.001--Not Available
Renal mass20.01.02.0070.001061%Not Available
Tongue neoplasm16.13.09.001; 07.21.08.0010.000241%Not Available
Renal impairment20.01.03.010--Not Available
Sinus disorder22.04.06.0020.033708%
Nail ridging23.02.05.0200.001350%
Unevaluable event08.01.03.0510.126415%Not Available
Middle ear effusion04.05.03.0010.001760%Not Available
Allergic respiratory symptom22.12.02.001; 10.01.03.0270.001640%Not Available
Bowel movement irregularity07.02.03.0030.022134%Not Available
Skin haemorrhage24.07.01.103; 23.06.07.0010.014322%Not Available
Dark circles under eyes08.01.03.054; 06.08.03.0190.000820%Not Available
Bronchial disorder22.03.02.0090.000820%Not Available
Bronchial hyperreactivity22.03.01.0160.000820%Not Available
Tendon pain15.07.01.0090.005449%Not Available
Regurgitation07.01.07.0040.001591%Not Available
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