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)
Painful respiration22.12.02.0110.001181%Not Available
Palpitations02.11.04.012--
Pancreatitis07.18.01.001--
Papule23.03.03.0380.010079%Not Available
Parathyroid disorder05.04.03.0010.000241%Not Available
Parosmia17.04.04.002; 22.04.03.0070.005811%Not Available
Pharyngeal ulceration22.04.05.0040.000820%Not Available
Pregnancy18.08.02.0040.038216%Not Available
Productive cough22.02.03.0050.028427%
Prostatic disorder21.04.01.0010.001254%Not Available
Pruritus23.03.12.0010.456764%
Psoriasis23.03.14.002; 10.02.01.0362.787406%Not Available
Psoriatic arthropathy15.01.10.001; 10.02.01.031; 23.03.14.0050.442321%Not Available
Pulmonary congestion22.01.03.002; 24.03.08.001; 02.05.02.0020.007040%Not Available
Pustular psoriasis10.02.01.102; 23.03.14.0060.004099%Not Available
Rash23.03.13.0010.619852%Not Available
Rash macular23.03.13.0030.049959%Not Available
Rash papular23.03.13.017--Not Available
Rash pruritic23.03.13.0300.065486%Not Available
Renal pain20.02.03.0030.010030%Not Available
Respiratory disorder22.02.07.0020.032164%Not Available
Retching07.01.07.0020.022399%Not Available
Rheumatoid arthritis15.01.03.001; 10.04.06.0010.020880%Not Available
Rhinorrhoea22.12.03.0210.091912%
Rosacea23.02.08.0010.003810%Not Available
Sacroiliitis10.02.01.104; 15.01.01.012--Not Available
Saliva altered07.06.01.0040.000530%Not Available
Salivary gland enlargement07.06.03.0020.000820%Not Available
Scab23.03.03.0040.007499%Not Available
Seborrhoea23.02.07.0010.003689%Not Available
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