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)
Adverse reaction08.06.01.0180.033153%Not Available
Gastrointestinal sounds abnormal07.01.01.0020.009669%Not Available
Head and neck cancer16.16.01.0030.000362%Not Available
Oropharyngeal blistering22.12.03.014; 07.05.05.0060.000530%Not Available
Upper-airway cough syndrome22.12.03.0360.009138%
Nail bed disorder23.02.05.0170.001230%Not Available
Skin sensitisation23.03.03.052; 10.02.01.0380.002580%Not Available
Functional gastrointestinal disorder07.11.01.0160.003930%Not Available
Resting tremor17.01.06.0080.000820%Not Available
Hepatic cancer16.07.02.004; 09.04.02.008--Not Available
Faeces soft07.01.03.0080.063003%Not Available
Respiratory symptom22.12.02.0130.004340%Not Available
Invasive breast carcinoma21.05.01.013; 16.10.01.0050.000241%Not Available
Excessive cerumen production04.01.01.0040.000530%Not Available
Gingival discomfort07.09.13.0030.000820%Not Available
Abdominal mass07.01.01.0030.000892%Not Available
Adjustment disorder with depressed mood19.23.01.0020.000940%Not Available
Alcoholic liver disease09.01.07.0310.000362%Not Available
Alopecia areata23.02.02.008; 10.04.02.0110.000940%Not Available
Behcet's syndrome06.04.05.017; 24.12.04.003; 23.06.02.004; 21.10.03.009; 15.01.01.009; 10.02.02.015; 07.05.06.0080.010175%Not Available
Bleeding varicose vein24.10.04.0020.000241%Not Available
Blood blister23.03.01.028; 12.01.06.0130.002580%Not Available
Guttate psoriasis10.02.01.076; 23.03.14.0080.001881%Not Available
Hairy cell leukaemia16.01.06.002; 01.10.06.0020.000241%Not Available
Lichen sclerosus23.03.08.006; 21.10.03.0100.000940%Not Available
Lung carcinoma cell type unspecified stage IV22.08.01.019; 16.19.02.0060.000482%Not Available
Mitral valve prolapse02.07.01.0080.000940%Not Available
Nail psoriasis10.02.01.094; 23.03.14.0090.002291%Not Available
Ovarian cyst ruptured21.11.01.015; 16.04.03.0060.000362%Not Available
Pityriasis rosea23.03.08.0030.000820%Not Available
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