Drugs › Phosphodiesterase 4 inhibitor
Generic name
Apremilast: adverse event reports filed with FDA
5,247 reports list it as a suspect or interacting product, 2014–2026. Class: Phosphodiesterase 4 inhibitor.
- 5,247
- reports as suspect product
- 0% of all reports · about 426 a year
- 880
- reports, 12 months to June 2026
- 1,261 in the 12 months before
- 77.5%
- marked serious by the reporter
- 23% across the class
- 44.4%
- record death among outcomes, as reported
- 2,328 reports · not verified by FDA
Between March 2014 and June 2026, 5,247 adverse event reports received by FDA list apremilast, a generic name as a suspect or interacting product. Reports that mention it only as a concomitant medication (926) are left out of every figure here.
In the 12 months to June 2026, 880 reports listed it, down 30% from 1,261 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Over its reporting history that is about 426 reports a year and 0% of the 20,646,523 reports in the database, and 3.4% of the reports for the phosphodiesterase 4 inhibitor class. How many people take it is not in the data, so a count is not a rate of occurrence.
Reporters most often recorded off label use (35%), drug ineffective (28.8%) and psoriatic arthropathy (25.3%). A report can list several reactions, so shares add to more than 100%; 663 different terms appear across these reports. Off label use is recorded in 35% of these reports, a larger share than in the median phosphodiesterase 4 inhibitor drug (6.3%).
77.5% of the reports are marked serious by the reporter (23% across the class); 44.4% record death among the outcomes and 49.6% record hospitalisation, as reported. 67.8% of the reports came from other health professionals, and the largest patient age group is 18 to 44 (40.7%). FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event."
Reports by month, five years
Reports by the month FDA received them. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.
By year received
2026 covers reports received through June 2026 only.
Reactions recorded in the reports
share of Apremilast reports recording the termmedian drug in phosphodiesterase 4 inhibitor
- Off label useused for a purpose or in a way not on the label35%1,836
- Drug ineffectivethe medicine did not work as expected28.8%1,511
- Psoriatic arthropathy25.3%1,325
- Headachehead pain24.4%1,278
- Synovitis24.3%1,275
- Fatiguetiredness24.1%1,267
- Rashskin rash24%1,257
- Nauseafeeling sick23.7%1,242
- Rheumatoid arthritisrheumatoid arthritis, an inflammatory joint disease23.4%1,227
- Infusion related reactiona reaction during or soon after an infusion22.8%1,198
- Painpain, site not specified22.2%1,165
- Hypertensionhigh blood pressure22.2%1,164
- General physical health deteriorationgeneral decline in health21.9%1,151
- Drug intolerancethe medicine was not tolerated21.6%1,134
- Wound21.4%1,122
- Joint swellinga swollen joint21.2%1,111
- Hypersensitivityan allergic-type reaction21.1%1,109
- Arthralgiajoint pain20.9%1,095
- Diarrhoealoose or frequent stools20.8%1,092
- Glossodynia20.7%1,087
- Type 2 diabetes mellitustype 2 diabetes20.7%1,086
- Systemic lupus erythematosuslupus, an autoimmune disease20.6%1,081
- Hypoaesthesianumbness20.6%1,080
- Hand deformity20.6%1,079
- Hepatic enzyme increasedraised liver enzymes20.6%1,079
- Abdominal discomfortstomach discomfort20.2%1,062
- Condition aggravatedthe condition being treated got worse20.1%1,056
- Alopeciahair loss19.9%1,043
- Pericarditisinflammation of the sac around the heart19.6%1,028
- Blood cholesterol increasedraised cholesterol19.3%1,012
Top 30 of 663 MedDRA preferred terms recorded across these reports, with a plain-language gloss where one is available. One report can record several terms. The hollow bar is the median share across the 5 drugs in the phosphodiesterase 4 inhibitor class; it describes the reports, not the patients. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."
Outcomes recorded
Outcome flags as the reporter set them; a report can carry several, and "other serious" is FDA's own category for serious reports outside the named outcomes. Grey bar: all 152,432 reports in the class. FDA has not verified any outcome and states that the reports "cannot be used to estimate the incidence of these events."
Patients and reporters
Patient age
Patient sex
Who reported
Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 28.8% of reports give the United States as the country of the event or reporter.
Reason for use recorded
| Indication as recorded (MedDRA) | Reports | Share |
|---|---|---|
| Psoriasis | 978 | 18.6% |
| Rheumatoid arthritis | 671 | 12.8% |
| Psoriatic arthropathy | 392 | 7.5% |
| Complex regional pain syndrome | 51 | 1% |
| Behcet's syndrome | 37 | 0.7% |
| Generalised pustular psoriasis | 30 | 0.6% |
The indication field is filled in by the reporter and is often blank; shares are of all 5,247 reports.
Drugs most often listed in the same reports
| Drug (any role in the report) | Reports | Share of Apremilast reports |
|---|---|---|
| Methotrexate | 2,922 | 55.7% |
| Prednisone | 2,751 | 52.4% |
| Enbrel | 2,546 | 48.5% |
| Adalimumab | 2,544 | 48.5% |
| Sulfasalazine | 2,537 | 48.4% |
| Cimzia | 2,520 | 48% |
| Folic acid | 2,516 | 48% |
| Infliximab | 2,408 | 45.9% |
| Desoximetasone | 2,397 | 45.7% |
| Humira | 2,384 | 45.4% |
Other products listed in reports where Apremilast is a suspect product, whatever their own role. Co-listing means the two were recorded together; it says nothing about either product's part in the event. Only the 2,500 most-reported names are counted here.
In context
| Measure | Apremilast | Phosphodiesterase 4 inhibitor | All reports |
|---|---|---|---|
| Reports as suspect product | 5,247 | 152,432 | 20,646,523 |
| Share of that pool | — | 3.4% | 0% |
| Reports, latest 12 months | 880 | — | 1,332,454 |
| Marked serious | 77.5% | 23% | 57.4% |
| Death recorded among outcomes, per 1,000 reports | 444 | 48 | 91 |
| Hospitalisation recorded, per 1,000 reports | 496 | 81 | 213 |
| Consumer-filed share | 13.4% | 24.7% | 45.8% |
| Top term, share of reports | Off label use 35% | median 6.3% | 4.1% |
Shares are of reports, not of patients treated. The number of people taking a product is not in the data, so none of these figures is a rate, and differences between columns reflect who takes a product, who reports and how long it has been sold. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."
Other drugs in the phosphodiesterase 4 inhibitor class
| Drug | Name type | Reports | Latest 12 months | Marked serious |
|---|---|---|---|---|
| Otezla | brand | 135,710 | 3,344 | 20.6% |
| Eucrisa | brand | 7,751 | 92 | 5.1% |
| Daliresp | brand | 2,443 | 14 | 58.4% |
| Roflumilast | generic | 1,281 | 112 | 92.7% |
Ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic." A brand and its generic are separate rows because reporters name them separately.
Questions about Apremilast reports
How many adverse event reports has FDA received for Apremilast?
5,247 reports list Apremilast as a suspect or interacting product in the openFDA FAERS release of 28 Sep 2026, covering reports received through June 2026. 880 of them arrived in the latest 12 months. Another 926 list it only as a concomitant medication.
What reactions are recorded in Apremilast reports?
off label use (35%), drug ineffective (28.8%), psoriatic arthropathy (25.3%), headache (24.4%) and synovitis (24.3%). These are MedDRA preferred terms coded from what the reporter described; a report can list several, and a term's presence is not a finding that Apremilast was responsible.
How serious are the reports?
77.5% are marked serious by the reporter. Among the outcomes recorded, 44.4% of reports include death and 49.6% include hospitalisation. FDA has not verified these outcomes and states that the reports "cannot be used to estimate the incidence" of the events.
Who files these reports?
other health professional (67.8%), physician (17.1%) and consumer or non-health professional (13.4%). Most reports reach FDA through the manufacturer, which must forward reports it receives.
Are reports for Apremilast rising?
880 reports in the 12 months to June 2026, down 30% from 1,261 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Counts also move with how many people take a product, its time on the market and publicity.
Do these reports show that Apremilast was responsible for these reactions?
No. FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event." The reaction may relate to the condition being treated, to other medicines, or to something else.
Is this a list of the side effects of Apremilast?
No. It is a count of what was reported to FDA. The adverse reactions observed in clinical studies are printed on the FDA-approved label, which a pharmacist or clinician can go through with you.
How do I report an adverse event?
Consumers and health professionals can report to FDA through MedWatch (Form FDA 3500 online, or 1-800-FDA-1088), or to the manufacturer, which must pass reports on. See the guide on how to report.
Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A report counts here when it lists Apremilast as a suspect or interacting product; reports listing it only as a concomitant medication (926) are excluded. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.
Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.