85/100 · Critical
Manufactured by Celgene Corporation
High Safety Concerns with Thalidomide: Severe Reactions and Widespread Adverse Effects
58,680 FDA adverse event reports analyzed
Last updated: 2026-05-12
THALIDOMIDE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Celgene Corporation. Based on analysis of 58,680 FDA adverse event reports, THALIDOMIDE has a safety score of 85 out of 100. This score indicates a relatively favorable safety profile, with fewer or less severe adverse events compared to many other tracked medications. The most commonly reported adverse reactions for THALIDOMIDE include DEATH, DISEASE PROGRESSION, PLASMA CELL MYELOMA, NEUROPATHY PERIPHERAL, PNEUMONIA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for THALIDOMIDE.
Thalidomide has a safety concern score of 85 out of 100, placing it in the high concern category based on analysis of FDA adverse event data. The FDA has received approximately 58,680 adverse event reports for this medication, which is primarily manufactured by Celgene Corporation.
The most commonly reported adverse events include Death, Disease Progression, Plasma Cell Myeloma. Of classified reports, 88.7% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Thalidomide reports include a high number of serious adverse events, with death being the most frequent.
Peripheral neuropathy and thrombosis are among the most common neurological and vascular side effects. The drug is associated with a wide range of adverse reactions, indicating a complex safety profile.
Patients taking Thalidomide should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Thalidomide is contraindicated in pregnant women due to severe teratogenic effects. It can also interact with other drugs, leading to increased toxicity. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Thalidomide received a safety concern score of 85/100 (high concern). This is based on a 88.7% serious event ratio across 36,075 classified reports. The score accounts for 58,680 total adverse event reports and 100 distinct reaction types. This high score reflects a significant proportion of serious adverse events in the reporting data.
Adverse event reports by sex: Male: 18,294, Female: 14,126, Unknown: 364. The most frequently reported age groups are age 68 (760 reports), age 70 (751 reports), age 67 (748 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 36,075 classified reports for THALIDOMIDE:
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.
Thalidomide is contraindicated in pregnant women due to severe teratogenic effects. It can also interact with other drugs, leading to increased toxicity.
If you are taking Thalidomide, here are important things to know. The most commonly reported side effects include death, disease progression, plasma cell myeloma, neuropathy peripheral, pneumonia. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Patients should report any new or worsening symptoms to their healthcare provider immediately. Pregnant women or those who may become pregnant should avoid this drug and use effective contraception. 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.
Thalidomide is subject to strict regulatory oversight and is only approved for specific conditions. Patients should be closely monitored for adverse reactions.
The FDA has received approximately 58,680 adverse event reports associated with Thalidomide. 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 Thalidomide include Death, Disease Progression, Plasma Cell Myeloma, Neuropathy Peripheral, Pneumonia. By volume, the top reported reactions are: Death (6,389 reports), Disease Progression (2,483 reports), Plasma Cell Myeloma (1,995 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Thalidomide.
Out of 36,075 classified reports, 31,987 (88.7%) were classified as serious and 4,088 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 Thalidomide break down by patient sex as follows: Male: 18,294, Female: 14,126, Unknown: 364. 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 Thalidomide adverse events are: age 68: 760 reports, age 70: 751 reports, age 67: 748 reports, age 64: 739 reports, age 65: 733 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 Thalidomide adverse event reports is Celgene Corporation. 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 Thalidomide include: Off Label Use, Fatigue, Drug Ineffective, Asthenia, Anaemia. 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 Thalidomide 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.
Thalidomide has a safety concern score of 85 out of 100 (high 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. Thalidomide reports include a high number of serious adverse events, with death being the most frequent.
Key safety signals identified in Thalidomide's adverse event data include: High frequency of death reports (6,389 out of 58,680, 10.9%). Severe neurological reactions such as peripheral neuropathy and dizziness. Multiple myeloma and cancer progression are reported as serious outcomes. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Thalidomide is contraindicated in pregnant women due to severe teratogenic effects. It can also interact with other drugs, leading to increased toxicity. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Thalidomide.
Patients should report any new or worsening symptoms to their healthcare provider immediately. Pregnant women or those who may become pregnant should avoid this drug and use effective contraception.
Thalidomide has 58,680 adverse event reports on file with the FDA. Peripheral neuropathy and thrombosis are among the most common neurological and vascular side effects. The volume of reports for Thalidomide reflects both the drug's usage level and the vigilance of the reporting community.
Thalidomide is subject to strict regulatory oversight and is only approved for specific conditions. Patients should be closely monitored for adverse reactions. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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