Drug side effects
apremilast Side Effects
The reactions most often reported to the FDA for apremilast (also sold as Otezla), with demographics, serious outcomes, and reporting trends.
Data updated 2026-05-15
- 143,174
- FAERS reports
Data from the FDA Adverse Event Reporting System (FAERS), 2012 to 2025. A FAERS report records a temporal association, not proof of cause. See our methodology for how figures are compiled and de-duplicated.
The most commonly reported side effects of apremilast come from 143,174 reports to the FDA, broken down here by frequency, patient demographics, and serious outcomes.
This page analyzes 143,174 reports to the FDA Adverse Event Reporting System (FAERS) for apremilast (Otezla): the reactions reported most often, who reported them, serious outcomes such as hospitalization, and year-over-year trends. A FAERS report does not prove the drug caused the effect, and report volume tracks how widely a drug is used, not how likely an effect is for any one person. Educational information, not medical advice.
Total Reports
143,174
Reports Mentioning Death
5,453
3.8% of reports — not proof the medicine caused the death
Hospitalizations
10,932
7.6% of reports
Top Indication
Psoriasis
Most Reported Adverse Reactions
Who Reports Side Effects
Gender Distribution
Age Distribution
Reporting Trend by Year
Reactions in Death Reports
Top reactions reported in 5,453 reports where death was an outcome. These are voluntarily reported and do not establish causation.
| Reaction | Reports |
|---|---|
| SYSTEMIC LUPUS ERYTHEMATOSUS | 1,750 |
| TYPE 2 DIABETES MELLITUS | 1,746 |
| PSORIATIC ARTHROPATHY | 1,731 |
| GLOSSODYNIA | 1,729 |
| GENERAL PHYSICAL HEALTH DETERIORATION | 1,721 |
| RASH | 1,714 |
| SYNOVITIS | 1,712 |
| HYPOAESTHESIA | 1,707 |
| INFUSION RELATED REACTION | 1,704 |
| HYPERTENSION | 1,703 |
| RHEUMATOID ARTHRITIS | 1,695 |
| WOUND | 1,677 |
| HAND DEFORMITY | 1,667 |
| JOINT SWELLING | 1,630 |
| HEPATIC ENZYME INCREASED | 1,621 |
| FIBROMYALGIA | 1,617 |
| SWELLING | 1,607 |
| HELICOBACTER INFECTION | 1,580 |
| DUODENAL ULCER PERFORATION | 1,578 |
Reactions in Hospitalization Reports
Top reactions in 10,932 reports where hospitalization was an outcome.
| Reaction | Reports |
|---|---|
| PSORIATIC ARTHROPATHY | 2,086 |
| RASH | 2,053 |
| FATIGUE | 2,009 |
| DIARRHOEA | 1,929 |
| RHEUMATOID ARTHRITIS | 1,924 |
| HEADACHE | 1,920 |
| NAUSEA | 1,917 |
| SYNOVITIS | 1,894 |
| PAIN | 1,893 |
| JOINT SWELLING | 1,834 |
| ARTHRALGIA | 1,822 |
| GENERAL PHYSICAL HEALTH DETERIORATION | 1,798 |
| VOMITING | 1,795 |
| INFUSION RELATED REACTION | 1,779 |
| HYPERTENSION | 1,774 |
| ARTHROPATHY | 1,769 |
| SYSTEMIC LUPUS ERYTHEMATOSUS | 1,718 |
| MALAISE | 1,716 |
Nearby, Related Medications
What the FAERS Data Reveals About apremilast Side Effects
The FDA Adverse Event Reporting System (FAERS) contains 143,174 voluntary reports linked to apremilast and its brand equivalents (Otezla), spanning 2012 through 2025. Of those, 5,453 (3.8%) listed death as an outcome and 10,932 (7.6%) involved hospitalization. The most common indication reported alongside adverse events was Psoriasis.
Demographic breakdowns help contextualize who is being exposed to the drug. Of reports with known sex, 66% were female and 34% male; age distribution skews toward 45-64, with 40,417 reports in that bracket. The single most reported reaction is diarrhoea with 24,315 submissions, followed by nausea and psoriasis.
How to read these numbers
FAERS is a signal-detection tool, not a scorecard. Reports are voluntary, and a single case may list multiple suspect drugs, so numbers above should not be read as incidence rates or per-patient risk. Widely prescribed drugs naturally accumulate more reports than niche therapies even when individual risk is low. These aggregates are useful for spotting patterns that merit further pharmacovigilance, not for choosing between medications. This page is for educational reference only and is not medical advice, speak with a licensed clinician about any side-effect concerns.
Drugs With a Similar FAERS Report Volume
Other medications with a total FDA adverse-event report count closest to apremilast's 143,174.
Read our methodology - how this data is sourced, computed, and verified.