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Apremilast Side Effects

The most commonly reported side effects of apremilast include diarrhoea, nausea, and psoriasis, based on 143,200 FDA adverse event reports from 2010 to 2025. 10.7% of reports found the drug to be ineffective.

Apremilast side effects

Percentages show how often each reaction appears relative to total reports for apremilast.

1
Diarrhoea17.0%24,315
2
Nausea15.3%21,930
3
Psoriasis14.1%20,248
4
Headache12.3%17,681
5
Drug Ineffective10.7%15,315
6
Abdominal Discomfort5.6%8,065
7
Psoriatic Arthropathy5.5%7,852
8
Pain4.6%6,596
9
Rash4.5%6,479
10
Vomiting4.4%6,348
11
Arthralgia4.3%6,226
12
Fatigue4.2%6,026
13
Depression3.8%5,416
14
Off Label Use3.5%5,024
15
Weight Decreased3.5%4,954

These are voluntary reports and do not establish that apremilast caused these reactions.

Report severity

23.0%Serious33,006 reports
7.6%Hospitalizations10,938 reports
3.8%Fatal5,454 reports

Seriousness is determined by the reporter, not by OpenClaim.

Apremilast drug interactions

Other drugs that appear in adverse event reports alongside apremilast. Drugs flagged as a suspected cause appear in the first column. Drugs taken at the same time but not suspected appear in the second.

Also suspected

1
Adalimumab5.2%7,500
2
Etanercept5.0%7,125
3
Methotrexate4.9%7,000
4
Secukinumab4.5%6,468
5
Certolizumab-pegol3.6%5,219
6
Infliximab3.6%5,207
7
Abatacept3.6%5,193
8
Leflunomide3.5%5,075
9
Ustekinumab3.5%4,950
10
Golimumab3.4%4,935
11
Sulfasalazine3.3%4,753
12
Hydroxychloroquine-sulfate3.2%4,532
13
Tocilizumab3.2%4,513
14
Diclofenac3.1%4,458
15
Prednisone3.1%4,412

Taken alongside

1
Ergocalciferol4.5%6,384
2
Levothyroxine-sodium3.8%5,492
3
Lisinopril3.8%5,420
4
Methotrexate3.7%5,369
5
Acetaminophen3.3%4,732
6
Prednisone3.0%4,225
7
Folic-acid2.9%4,149
8
Ibuprofen2.9%4,096
9
Clobetasol-propionate2.8%4,061
10
Atorvastatin-calcium2.8%4,008
11
Metformin2.8%3,958
12
Omeprazole2.6%3,766
13
Pantoprazole-sodium2.3%3,354
14
Aspirin2.3%3,273
15
Gabapentin2.1%3,019

Co-occurrence in adverse event reports does not establish a drug interaction. Patients often take multiple medications, and these lists reflect prescribing patterns rather than causal relationships. Consult a healthcare provider about potential drug interactions.

Who reports apremilast side effects

63.1% of apremilast adverse event reports involve female patients and 32.4% involve male patients. The largest age group is adult at 77%. These figures reflect who reports side effects, not underlying risk.

Sex

Female63.1%
Male32.4%
Unknown4.5%

Age group

< 20.1%
2–11<0.1%
12–170.2%
18–6477.3%
65+22.3%

What is apremilast used for

Conditions and purposes for which patients were taking apremilast when the adverse event was reported.

Abdominal DiscomfortAbdominal Pain UpperAcneAcne ConglobataActinic KeratosisAdjustment Disorder With AnxietyAdverse Drug ReactionAdverse EventAffective DisorderAlopeciaAlopecia AreataAlopecia ScarringAlopecia UniversalisAmyotrophic Lateral SclerosisAngina Unstable

Showing 15 of 700 indications

Apremilast brand names and reporting trend

Apremilast is sold under the brand name Apremilast.

Brand names

Apremilast9,533

Quarterly reports (20102025)

20102016202020242025

An upward trend reflects increased FAERS reporting overall, not necessarily increased risk.

Taking apremilast with another medication?

Ask OpenClaim about your specific drug combination. Get a sourced report using FDA data, drug labels, and medical literature.