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 fatigue17.03.03.006; 19.21.02.0120.000820%-
Helplessness19.01.02.0130.000820%-
Allergy to plants10.01.03.0520.000820%-
Bile acid malabsorption07.17.01.0120.000530%-
Cutaneous T-cell lymphoma01.11.03.002; 16.17.03.002; 23.07.04.0290.000603%-
Drug effect less than expected08.06.01.0360.010657%-
Endocrine ophthalmopathy05.02.02.008; 06.09.04.008; 10.04.08.012; 14.11.01.0510.000241%-
Gait inability08.01.02.011; 17.02.05.069---
Giant cell arteritis06.07.02.010; 10.02.02.032; 17.08.02.033; 24.12.02.0030.000772%-
Hyperaesthesia teeth07.09.06.0050.001061%-
Illness08.01.03.091---
Intra-abdominal fluid collection07.07.01.014; 21.07.04.0140.000651%-
Limb mass15.03.05.0190.001350%-
Loss of therapeutic response08.06.01.0410.003810%-
Near death experience17.02.04.023; 19.10.05.0070.000820%-
Palmoplantar pustulosis10.02.01.099; 23.03.14.0110.004750%-
Pancreatic failure07.18.02.0110.000362%-
Parapsoriasis23.03.08.0050.000530%-
Sinus pain22.12.03.0230.003400%
Sleep disorder due to a general medical condition19.02.04.0030.004340%-
Symptom recurrence08.01.03.1010.008318%-
Therapeutic product effect decreased08.06.01.0500.312651%-
Therapeutic product effect delayed08.06.01.0510.006920%-
Therapeutic product effect incomplete08.06.01.0520.152359%-
Therapeutic product ineffective08.06.01.057---
Therapeutic response shortened08.06.01.062---
Therapy non-responder08.06.01.0630.479404%-
Therapy partial responder08.06.01.0640.030356%-
Therapy responder08.06.01.0650.001230%-
Throat clearing22.12.03.0280.000820%-
The 13th Page    First    Pre   13 14    Next   Last    Total 14 Pages