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)
Mental fatigue19.21.02.012; 17.03.03.0060.000820%Not Available
Helplessness19.01.02.0130.000820%Not Available
Allergy to plants10.01.03.0520.000820%Not Available
Bile acid malabsorption07.17.01.0120.000530%Not Available
Cutaneous T-cell lymphoma16.17.03.002; 01.11.03.002; 23.07.04.0290.000603%Not Available
Drug effect less than expected08.06.01.0360.010657%Not Available
Endocrine ophthalmopathy14.11.01.051; 10.04.08.012; 06.09.04.008; 05.02.02.0080.000241%Not Available
Gait inability08.01.02.011; 17.02.05.069--Not Available
Giant cell arteritis06.07.02.010; 24.12.02.003; 17.08.02.033; 10.02.02.0320.000772%Not Available
Hyperaesthesia teeth07.09.06.0050.001061%Not Available
Illness08.01.03.091--Not Available
Intra-abdominal fluid collection21.07.04.014; 07.07.01.0140.000651%Not Available
Limb mass15.03.05.0190.001350%Not Available
Loss of therapeutic response08.06.01.0410.003810%Not Available
Near death experience19.10.05.007; 17.02.04.0230.000820%Not Available
Palmoplantar pustulosis23.03.14.011; 10.02.01.0990.004750%Not Available
Pancreatic failure07.18.02.0110.000362%Not Available
Parapsoriasis23.03.08.0050.000530%Not Available
Sinus pain22.12.03.0230.003400%
Sleep disorder due to a general medical condition19.02.04.0030.004340%Not Available
Symptom recurrence08.01.03.1010.008318%Not Available
Therapeutic product effect decreased08.06.01.0500.312651%Not Available
Therapeutic product effect delayed08.06.01.0510.006920%Not Available
Therapeutic product effect incomplete08.06.01.0520.152359%Not Available
Therapeutic product ineffective08.06.01.057--Not Available
Therapeutic response shortened08.06.01.062--Not Available
Therapy non-responder08.06.01.0630.479404%Not Available
Therapy partial responder08.06.01.0640.030356%Not Available
Therapy responder08.06.01.0650.001230%Not Available
Throat clearing22.12.03.0280.000820%Not Available
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