What the label lists and what reports show
Apremilast side effects
Apremilast's FDA label: “The most common adverse reactions (≥ 5%) are diarrhea, nausea, and headache ( 6.1 ) Plaque Psoriasis: The most common adverse reactions (≥ 5%) are diarrhea, nausea, upper respiratory tract infection, and headache, including tension headache ( 6.1 ) Behçet's …” FAERS holds 145,481 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is diarrhoea (24,624 reports).
- No generic listed
Check it at the source: the apremilast FDA label on DailyMed (effective September 2, 2026, Amgen, Inc); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsThe most common adverse reactions (≥ 5%) are diarrhea, nausea, and headache ( 6.1 ) Plaque Psoriasis: The most common adverse reactions (≥ 5%) are diarrhea, nausea, upper respiratory tract infection, and headache, including tension headache ( 6.1 ) Behçet's Disease: The most common adverse reactions (≥ 10%) are diarrhea, nausea, headache, and upper respiratory tract infection ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Amgen Inc.
Table 4. Adverse Reactions Reported in ≥ 1% of Adult Subjects with Moderate to Severe Plaque Psoriasis on OTEZLA and With Greater Frequency Than in Subjects on Placebo up to Day 112 (Week 16)
| Adverse Reactions | Placebo (N = 506) n (%) | OTEZLA 30 mg BID BID = twice daily. (N = 920) n (%) |
|---|---|---|
| Diarrhea | 32 (6) | 160 (17) |
| Nausea | 35 (7) | 155 (17) |
| Upper respiratory tract infection | 31 (6) | 84 (9) |
| Tension headache | 21 (4) | 75 (8) |
| Headache | 19 (4) | 55 (6) |
| Abdominal pain Two subjects treated with OTEZLA experienced serious adverse reaction of… | 11 (2) | 39 (4) |
| Vomiting | 8 (2) | 35 (4) |
| Fatigue | 9 (2) | 29 (3) |
| Dyspepsia | 6 (1) | 29 (3) |
| Decreased appetite | 5 (1) | 26 (3) |
| Insomnia | 4 (1) | 21 (2) |
| Back pain | 4 (1) | 20 (2) |
| Migraine | 5 (1) | 19 (2) |
| Frequent bowel movements | 1 (0) | 17 (2) |
| Depression | 2 (0) | 12 (1) |
| Bronchitis | 2 (0) | 12 (1) |
| Tooth abscess | 0 (0) | 10 (1) |
| Folliculitis | 0 (0) | 9 (1) |
| Sinus headache | 0 (0) | 9 (1) |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe following adverse reactions are described elsewhere in the labeling: Hypersensitivity [see Warnings and Precautions (5.1) ] Diarrhea, Nausea, and Vomiting [see Warnings and Precautions (5.2) ] Depression [see Warnings and Precautions (5.3) ] Weight Decrease [see Warnings and Precautions (5.4) ] Drug Interactions [see Warnings and Precautions (5.5) ] Psoriatic Arthritis: The most common adverse reactions (≥ 5%) are diarrhea, nausea, and headache ( 6.1 ) Plaque Psoriasis: The most common adverse reactions (≥ 5%) are diarrhea, nausea, upper respiratory tract infection, and headache, including tension headache ( 6.1 ) Behçet's Disease: The most common adverse reactions (≥ 10%) are diarrhea, nausea, headache, and upper respiratory tract infection ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Amgen Inc. at 1-800-77-AMGEN (1-800-772-6436) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. …
Source: FDA drug label, Amgen, Inc, effective September 2, 2026 (SPL set f6b1f516-4972-4d82-bced-113e47b41cc5), via openFDA; the full label on DailyMed
What do FAERS reports show?
145,481 reports list apremilast among the medicines taken, each a report of something that happened, not proof the medicine caused it; 5,952 are coded as a death and 11,497 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 19 reactions below, 9 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Apremilast: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions