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)
Post inflammatory pigmentation change23.05.03.0020.000820%Not Available
Prostate cancer recurrent21.04.02.008; 16.25.01.0050.000241%Not Available
Seasonal affective disorder19.04.04.0070.000820%Not Available
Sleep disorder due to general medical condition, insomnia type19.02.04.0040.001230%Not Available
Stasis dermatitis24.10.04.004; 23.03.04.0410.000820%Not Available
Teeth brittle07.09.05.0150.001230%Not Available
Throat cancer22.08.02.008; 16.19.02.0070.001832%Not Available
Neck mass15.03.02.0070.001061%Not Available
Transient acantholytic dermatosis23.03.03.0690.000530%Not Available
Laziness19.04.04.0050.000820%Not Available
Joint warmth15.01.02.0090.000940%Not Available
Colon cancer metastatic16.13.01.012; 07.21.01.0100.000603%Not Available
Acute cutaneous lupus erythematosus23.03.02.017; 15.06.02.009; 10.04.03.0090.000241%Not Available
Negative thoughts19.15.02.0120.003713%Not Available
Sputum retention22.02.03.0120.000820%Not Available
Arterial stenosis24.04.02.0120.000241%Not Available
Onychalgia23.02.05.0260.001640%Not Available
Nail growth abnormal23.02.05.0240.001230%Not Available
Enlarged uvula07.05.01.0150.000530%Not Available
Stomach mass07.11.01.0300.000530%Not Available
Skin plaque23.03.03.0440.011839%Not Available
Rebound psoriasis10.02.01.103; 23.03.14.010; 08.06.02.0190.007161%Not Available
Subchorionic haemorrhage24.07.03.030; 18.02.01.0070.000241%Not Available
Soft tissue mass15.03.02.0190.000820%Not Available
Spinal pain17.10.01.020; 15.02.01.008; 08.01.08.030--Not Available
Tendon discomfort15.07.01.0120.001230%Not Available
Eyelid rash23.03.13.020; 06.04.04.0170.000820%Not Available
Cutaneous symptom23.07.04.0230.000651%Not Available
Lower respiratory tract congestion22.12.01.0040.000820%Not Available
Increased viscosity of upper respiratory secretion22.12.03.0080.000530%Not Available
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