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)
Ephelides23.05.01.0050.002580%Not Available
Episcleritis10.02.01.024; 06.04.07.0010.000820%Not Available
Eructation07.01.02.0030.015238%
Erythrodermic psoriasis10.02.01.074; 23.03.14.0070.000241%Not Available
Eye disorder06.08.03.001--Not Available
Faeces discoloured07.01.03.0020.020302%Not Available
Fatigue08.01.01.002--
Feeling jittery08.01.09.0160.019747%Not Available
Flatulence07.01.04.0020.113226%
Folliculitis23.11.04.003; 11.02.01.053--
Food allergy10.01.01.0120.004219%Not Available
Food poisoning12.03.01.024; 11.07.02.001; 07.11.01.0070.007499%Not Available
Frequent bowel movements07.02.04.0020.173939%Not Available
Gallbladder disorder09.03.02.0010.011863%Not Available
Gastrooesophageal reflux disease07.02.02.0030.115541%
Gastrointestinal disorder07.11.01.0010.473690%Not Available
Gastrointestinal pain07.01.05.0050.016781%
Genital ulceration23.07.03.004; 21.10.05.0010.000820%Not Available
Gingival recession07.09.13.0120.000530%Not Available
Gingival swelling07.09.13.0130.002990%Not Available
Gout15.01.06.001; 14.09.01.0010.021049%Not Available
Granuloma annulare23.03.15.0050.000820%Not Available
Haematemesis24.07.02.011; 07.12.02.002--Not Available
Haematochezia24.07.02.012; 07.12.02.003--Not Available
Haematospermia24.07.03.008; 21.03.03.0030.000820%Not Available
Haemoptysis02.11.04.009; 24.07.01.006; 22.02.03.004--Not Available
Hair disorder23.02.06.0030.000940%Not Available
Head discomfort17.02.05.0270.010488%Not Available
Headache17.14.01.0012.906492%
Hepatic cirrhosis09.01.04.001--Not Available
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