Pomalystpomalidomide
According to the FDA label: Pomalidomide capsules are a thalidomide analogue indicated for the treatment of adult patients: in combination with dexamethasone, for patients with multiple myeloma (MM) who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or within 60 days of completion of the last therapy ( 1.1 ).
100,554 adverse event reports submitted to the FDA (2011–2026)
Top Reported Adverse Events
The most frequently reported events in association with Pomalyst in the FAERS database. These are events reported by patients taking this medication, not necessarily caused by it. A single report may include multiple events.
Show these terms with plain-language definitions
Tap any term below for a plain-language definition.
Plasma Cell Myeloma 7,942 reports
A cancer of certain white blood cells in the bone marrow, also called multiple myeloma. It often appears in reports as a condition being treated.
Full definition in the glossary →Death 7,602 reports
A report that the person died. A death appearing in reports for a drug does not mean the drug caused it. Reports record that a death occurred while the medication was being used, which can happen for many unrelated reasons.
Full definition in the glossary →Fatigue 7,373 reports
Extreme tiredness or lack of energy that does not improve with rest.
Full definition in the glossary → See all drugs reporting this event →Pneumonia 6,221 reports
An infection that inflames the air sacs in the lungs, which can cause cough, fever, and difficulty breathing.
Full definition in the glossary →Off Label Use 4,481 reports
Using a medication for a condition or in a way that the FDA has not officially approved. This is common and often legal, and a report of it does not mean something went wrong. Doctors sometimes prescribe drugs off label based on their judgment.
Full definition in the glossary →Diarrhoea 3,829 reports
Loose or watery bowel movements, often frequent. Also spelled diarrhea in American English.
Full definition in the glossary → See all drugs reporting this event →White Blood Cell Count Decreased 3,618 reports
A blood test result showing a low level of white blood cells, which help fight infection.
Full definition in the glossary →Neutropenia 3,270 reports
A low level of neutrophils, a type of white blood cell that fights infection.
Full definition in the glossary →Rash 3,002 reports
An area of irritated, red, or bumpy skin.
Full definition in the glossary → See all drugs reporting this event →Dyspnoea 2,812 reports
Shortness of breath or difficulty breathing. Also spelled dyspnea in American English.
Full definition in the glossary → See all drugs reporting this event →Neuropathy Peripheral 2,641 reports
Damage to the nerves outside the brain and spinal cord, often causing numbness, tingling, or pain in the hands and feet.
Full definition in the glossary →Asthenia 2,640 reports
Physical weakness or lack of strength.
Full definition in the glossary →Constipation 2,629 reports
Difficulty passing stool, or having fewer bowel movements than usual.
Full definition in the glossary → See all drugs reporting this event →Nausea 2,514 reports
The feeling of sickness in your stomach that often comes before vomiting.
Full definition in the glossary → See all drugs reporting this event →Product Dose Omission Issue 2,226 reports
A report that a dose of the medication was missed or skipped.
Full definition in the glossary →
Ranked by frequency of reports, not severity. The most-reported event is not necessarily the most dangerous or the most common in patients taking this drug.
Who Is Reporting
Demographics of patients in FAERS reports that included this information. Not all reports include patient demographics.
By Sex
View reporter sex data as a table
| Sex | Reports |
|---|---|
| Male | 50,119 |
| Female | 46,840 |
| Unknown | 59 |
By Age Group
View age group data as a table
| Age group | Reports |
|---|---|
| 0-17 | 444 |
| 18-34 | 88 |
| 35-49 | 2,156 |
| 50-64 | 16,752 |
| 65-74 | 24,260 |
| 75+ | 23,380 |
This shows who filed reports, reflecting who takes this drug and who tends to report, not who is at greatest risk.
Reported Outcomes
Outcomes recorded in FAERS reports that included Pomalyst. A single report may involve multiple reactions, each with a different outcome. These categories are defined by FDA reporting guidelines, not by PillSignal.
View outcome data as a table
| Outcome | Reports |
|---|---|
| Non-Serious | 38,621 |
| Other Serious | 33,802 |
| Hospitalization | 26,872 |
| Death | 13,869 |
| Life-Threatening | 1,788 |
| Disability | 628 |
Serious outcomes are far more likely to be reported than mild ones, so this overstates how often outcomes are serious. A recorded death does not mean the drug caused it.
Report Volume Over Time
Number of FAERS reports received per quarter for Pomalyst. Changes in volume may reflect shifts in prescribing rates, media attention, or reporting behavior, not changes in the medication's safety profile.
View report trend as a table
| Year | Reports |
|---|---|
| 2011 | 2 |
| 2012 | 6 |
| 2013 | 1,217 |
| 2014 | 2,659 |
| 2015 | 5,383 |
| 2016 | 5,867 |
| 2017 | 6,831 |
| 2018 | 7,077 |
| 2019 | 9,195 |
| 2020 | 10,066 |
| 2021 | 13,134 |
| 2022 | 11,305 |
| 2023 | 8,274 |
| 2024 | 8,959 |
| 2025 | 8,597 |
| 2026 (partial) | 1,982 |
The steep increase around 2004 reflects the FDA's move to electronic submission, not a change in this drug's safety. Trends track reporting volume, not risk.
Medications commonly reported with Pomalyst
In FDA adverse event reports that mention Pomalyst, these medications appeared most often in the same report.
- Dexamethasone (27,865 reports)
- Acyclovir (12,647 reports)
- Aspirin (11,525 reports)
- Daratumumab (7,250 reports)
- Lenalidomide (7,008 reports)
This reflects co-occurrence in submitted reports, not evidence of drug interaction or combined risk. People often report several medications taken for the same condition or for unrelated reasons. Talk to a doctor or pharmacist about your specific medications.
Related Drugs
Other medications with similar adverse event profiles in FDA FAERS reports.
Data Source
This data is sourced from the FDA's Adverse Event Monitoring System (AEMS), formerly FAERS, via the OpenFDA API. PillSignal is not affiliated with the FDA.
View this data on the FDA website →Data last updated: June 2026