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)
Seborrhoeic dermatitis23.03.04.0180.001350%Not Available
Sinus congestion22.04.06.0010.012297%Not Available
Sinus headache22.12.03.022; 17.14.01.0020.022978%
Skin atrophy23.01.05.0010.007908%
Skin cancer23.08.02.002; 16.03.02.0020.007667%Not Available
Skin disorder23.03.03.0070.044268%Not Available
Skin exfoliation23.03.07.0030.051863%Not Available
Skin fissures23.03.03.0080.021917%Not Available
Skin fragility23.03.03.0090.001640%Not Available
Skin hypertrophy23.01.04.0020.001760%Not Available
Skin irritation23.03.04.0090.020278%Not Available
Skin odour abnormal23.03.03.0120.002700%
Skin ulcer24.04.03.007; 23.07.03.003--
Skin wrinkling23.01.03.0010.003279%Not Available
Squamous cell carcinoma of lung22.08.01.014; 16.19.01.0060.000241%Not Available
Squamous cell carcinoma of skin23.08.02.005; 16.03.02.0050.003665%Not Available
Stress19.06.02.0040.133022%Not Available
Suicidal ideation19.12.01.003--
Suicide attempt19.12.01.004--
Swelling face10.01.05.018; 08.01.03.100; 23.04.01.018--Not Available
Syncope02.11.04.015; 24.06.02.012; 17.02.04.008--
Temporomandibular joint syndrome17.14.01.017; 15.01.08.0080.001760%Not Available
Tension headache19.24.01.009; 17.14.01.0040.061411%Not Available
Therapeutic response decreased08.06.01.0160.212951%Not Available
Thrombosis24.01.01.006--Not Available
Tongue geographic07.14.01.0060.000530%Not Available
Tongue neoplasm malignant stage unspecified16.13.07.003; 07.21.07.0030.000651%Not Available
Tonsillar hypertrophy22.04.05.0060.000241%Not Available
Tooth abscess11.01.04.003; 07.09.01.003--Not Available
Toothache07.09.06.0010.010368%
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