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)
Chloasma23.05.01.001; 18.08.02.0020.001230%Not Available
Cirrhosis alcoholic09.01.04.0050.000241%Not Available
Claustrophobia19.06.03.0050.000530%Not Available
Colon cancer16.13.01.001; 07.21.01.001--Not Available
Condition aggravated08.01.03.0040.274241%Not Available
Costochondritis15.07.03.0010.000820%Not Available
Cough22.02.03.001--
Cyst16.02.02.002; 08.03.05.0010.006462%Not Available
Dandruff23.03.16.0010.003520%Not Available
Decreased interest19.15.02.0040.006389%Not Available
Defaecation urgency07.02.04.0010.014949%Not Available
Dehydration14.05.05.001--
Depressed mood19.15.02.0010.061435%Not Available
Depression19.15.01.0010.696454%
Depression suicidal19.15.01.0040.003014%Not Available
Dermatitis23.03.04.002--Not Available
Dermatitis atopic23.03.04.016; 10.01.04.0040.004340%Not Available
Diabetes mellitus14.06.01.001; 05.06.01.001--Not Available
Diarrhoea07.02.01.0014.340123%
Diarrhoea haemorrhagic07.02.01.002; 24.07.02.004--Not Available
Discomfort08.01.08.0030.089236%Not Available
Drug hypersensitivity10.01.01.001--Not Available
Drug ineffective08.06.01.0062.556059%Not Available
Dry eye06.08.02.001--
Dry skin23.03.03.0010.074721%
Dyshidrotic eczema23.03.04.0340.000820%Not Available
Dyspepsia07.01.02.0010.223391%
Ear disorder04.03.01.0010.004629%Not Available
Ear pain04.03.01.0030.011959%
Eczema23.03.04.006--
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