65/100 · Elevated
Manufactured by Amgen, Inc
Apremilast Adverse Events: Common Gastrointestinal and Musculoskeletal Issues
370,200 FDA adverse event reports analyzed
Last updated: 2026-05-12
APREMILAST is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Amgen, Inc. Based on analysis of 370,200 FDA adverse event reports, APREMILAST has a safety score of 65 out of 100. This moderate score indicates a notable volume of adverse event reports that patients and providers should be aware of. The most commonly reported adverse reactions for APREMILAST include DIARRHOEA, NAUSEA, PSORIASIS, HEADACHE, DRUG INEFFECTIVE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for APREMILAST.
Apremilast has a safety concern score of 65 out of 100, placing it in the elevated concern category based on analysis of FDA adverse event data. The FDA has received approximately 370,200 adverse event reports for this medication, which is primarily manufactured by Amgen, Inc.
The most commonly reported adverse events include Diarrhoea, Nausea, Psoriasis. Of classified reports, 23.0% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Gastrointestinal issues like diarrhea and nausea are the most common adverse events.
Musculoskeletal pain and arthralgia are frequently reported, indicating potential joint-related side effects. Serious adverse events account for 23% of all reports, with gastrointestinal and psychiatric issues being the most severe.
Patients taking Apremilast should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Apremilast can cause gastrointestinal issues such as diarrhea and nausea, and musculoskeletal pain. Patients should be monitored for these side effects, and alternative treatments may be considered if adverse reactions are severe. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Apremilast received a safety concern score of 65/100 (elevated concern). This is based on a 23.0% serious event ratio across 143,161 classified reports. The score accounts for 370,200 total adverse event reports and 100 distinct reaction types. This elevated score indicates a notable proportion of serious adverse events and warrants careful monitoring.
Adverse event reports by sex: Female: 90,394, Male: 46,320, Unknown: 12. The most frequently reported age groups are age 59 (2,713 reports), age 56 (2,429 reports), age 43 (2,374 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 143,161 classified reports for APREMILAST:
The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.
Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.
Apremilast can cause gastrointestinal issues such as diarrhea and nausea, and musculoskeletal pain. Patients should be monitored for these side effects, and alternative treatments may be considered if adverse reactions are severe.
If you are taking Apremilast, here are important things to know. The most commonly reported side effects include diarrhoea, nausea, psoriasis, headache, drug ineffective. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Monitor for gastrointestinal symptoms such as diarrhea and nausea, and consider dose adjustments or alternative treatments if necessary. Be aware of musculoskeletal pain and arthralgia, and report any severe or persistent symptoms to your healthcare provider. If you experience a serious adverse reaction, seek emergency medical attention immediately or call 911. You can report side effects to the FDA's MedWatch program at 1-800-FDA-1088.
The FDA continues to monitor the safety profile of Apremilast, and updates are regularly provided to healthcare providers and patients.
The FDA has received approximately 370,200 adverse event reports associated with Apremilast. These reports come from healthcare professionals, consumers, and manufacturers through the FDA Adverse Event Reporting System (FAERS). Note that the number of reports does not directly indicate the frequency of side effects, as adverse events are voluntarily reported and may be underrepresented.
The most frequently reported adverse events for Apremilast include Diarrhoea, Nausea, Psoriasis, Headache, Drug Ineffective. By volume, the top reported reactions are: Diarrhoea (24,315 reports), Nausea (21,927 reports), Psoriasis (20,247 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Apremilast.
Out of 143,161 classified reports, 32,991 (23.0%) were classified as serious and 110,170 as non-serious. The FDA classifies an event as "serious" if it results in death, hospitalization, disability, or other medically significant outcomes. A higher serious-event ratio warrants closer attention but does not necessarily mean the drug is unsafe.
Adverse event reports for Apremilast break down by patient sex as follows: Female: 90,394, Male: 46,320, Unknown: 12. This distribution reflects reporting patterns rather than actual risk differences between groups. Reporting rates can be influenced by prescribing patterns, disease demographics, and reporting behavior.
The most frequently reported age groups for Apremilast adverse events are: age 59: 2,713 reports, age 56: 2,429 reports, age 43: 2,374 reports, age 62: 2,362 reports, age 58: 2,323 reports. Age-related reporting patterns can reflect both the demographics of the patient population and potential age-related susceptibility to certain side effects.
The primary manufacturer associated with Apremilast adverse event reports is Amgen, Inc. Multiple manufacturers may produce generic versions of this drug. The manufacturer listed reflects the most frequently reported brand in FDA adverse event data.
Beyond the most common reactions, other reported adverse events for Apremilast include: Abdominal Discomfort, Psoriatic Arthropathy, Pain, Rash, Vomiting. Less common side effects can still be clinically significant. Patients should report any unusual symptoms to their healthcare provider.
You can report adverse events from Apremilast to the FDA through their MedWatch program at www.fda.gov/medwatch, by calling 1-800-FDA-1088, or by completing Form FDA 3500. Healthcare professionals, consumers, and manufacturers can all submit reports. Reporting helps the FDA monitor drug safety after approval.
Apremilast has a safety concern score of 65 out of 100 (elevated concern). This score is calculated from the ratio of serious to non-serious adverse events, the diversity of reported reactions, and the overall volume of reports relative to usage. Gastrointestinal issues like diarrhea and nausea are the most common adverse events.
Key safety signals identified in Apremilast's adverse event data include: Diarrhea and nausea are the most frequently reported reactions.. Musculoskeletal pain and arthralgia are significant safety signals.. Serious adverse events, particularly gastrointestinal and psychiatric issues, are notable.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Apremilast can cause gastrointestinal issues such as diarrhea and nausea, and musculoskeletal pain. Patients should be monitored for these side effects, and alternative treatments may be considered if adverse reactions are severe. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Apremilast.
Monitor for gastrointestinal symptoms such as diarrhea and nausea, and consider dose adjustments or alternative treatments if necessary. Be aware of musculoskeletal pain and arthralgia, and report any severe or persistent symptoms to your healthcare provider.
Apremilast has 370,200 adverse event reports on file with the FDA. Musculoskeletal pain and arthralgia are frequently reported, indicating potential joint-related side effects. The volume of reports for Apremilast reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor the safety profile of Apremilast, and updates are regularly provided to healthcare providers and patients. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
Explore other medications manufactured by Amgen, Inc and compare their safety profiles:
The following drugs share commonly reported adverse reactions with APREMILAST:
Drugs related to APREMILAST based on therapeutic use, drug class, or shared indications: