Thalomidthalidomide
According to the FDA label: • THALOMID in combination with dexamethasone is indicated for the treatment of patients with newly diagnosed multiple myeloma (MM). ( 1.1 ) • THALOMID is indicated for the acute treatment of the cutaneous manifestations of moderate to severe erythema nodosum leprosum (ENL). THALOMID is not indicated as monotherapy for such ENL treatment in the presence of moderate to severe neuritis.
36,316 adverse event reports submitted to the FDA (2004–2026)
Top Reported Adverse Events
The most frequently reported events in association with Thalomid 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.
Death 6,401 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 →Disease Progression 2,491 reports
A report that the underlying condition being treated got worse over time. This describes the course of the illness, not necessarily an effect of the drug.
Full definition in the glossary →Plasma Cell Myeloma 2,006 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 →Neuropathy Peripheral 1,819 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 →Off Label Use 1,722 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 →Pneumonia 1,710 reports
An infection that inflames the air sacs in the lungs, which can cause cough, fever, and difficulty breathing.
Full definition in the glossary →Fatigue 1,404 reports
Extreme tiredness or lack of energy that does not improve with rest.
Full definition in the glossary → See all drugs reporting this event →Drug Ineffective 1,134 reports
A report that the medication did not work as expected for the person taking it. This is a reporting category, not a sign the drug is defective. It simply means someone felt it was not helping their condition.
Full definition in the glossary →Anaemia 1,022 reports
A condition where there are too few healthy red blood cells to carry enough oxygen, often causing tiredness and paleness. Also spelled anemia in American English.
Full definition in the glossary → See all drugs reporting this event →Asthenia 1,022 reports
Physical weakness or lack of strength.
Full definition in the glossary →Constipation 995 reports
Difficulty passing stool, or having fewer bowel movements than usual.
Full definition in the glossary → See all drugs reporting this event →Dyspnoea 987 reports
Shortness of breath or difficulty breathing. Also spelled dyspnea in American English.
Full definition in the glossary → See all drugs reporting this event →Pyrexia 956 reports
The medical term for fever, meaning a raised body temperature.
Full definition in the glossary → See all drugs reporting this event →Thrombocytopenia 879 reports
A low level of platelets, the blood cells that help with clotting.
Full definition in the glossary →Nausea 863 reports
The feeling of sickness in your stomach that often comes before vomiting.
Full definition in the glossary → See all drugs reporting this event →
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 | 18,390 |
| Female | 14,241 |
| Unknown | 364 |
By Age Group
View age group data as a table
| Age group | Reports |
|---|---|
| 0-17 | 949 |
| 18-34 | 707 |
| 35-49 | 2,393 |
| 50-64 | 8,089 |
| 65-74 | 7,141 |
| 75+ | 5,755 |
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 Thalomid. 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 |
|---|---|
| Other Serious | 15,399 |
| Death | 12,142 |
| Hospitalization | 10,581 |
| Non-Serious | 4,130 |
| Life-Threatening | 1,215 |
| Disability | 783 |
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 Thalomid. 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 |
|---|---|
| 2004 | 4,416 |
| 2005 | 4,279 |
| 2006 | 809 |
| 2007 | 769 |
| 2008 | 2,021 |
| 2009 | 983 |
| 2010 | 900 |
| 2011 | 951 |
| 2012 | 956 |
| 2013 | 1,128 |
| 2014 | 1,621 |
| 2015 | 2,888 |
| 2016 | 1,716 |
| 2017 | 1,464 |
| 2018 | 1,456 |
| 2019 | 1,520 |
| 2020 | 1,487 |
| 2021 | 1,447 |
| 2022 | 1,635 |
| 2023 | 1,454 |
| 2024 | 1,182 |
| 2025 | 1,007 |
| 2026 (partial) | 227 |
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 Thalomid
In FDA adverse event reports that mention Thalomid, these medications appeared most often in the same report.
- Dexamethasone (9,703 reports)
- Bortezomib (7,689 reports)
- Cyclophosphamide (4,102 reports)
- Cyclophosphamide For (4,102 reports)
- Lenalidomide (3,352 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