82/100 · Critical
Manufactured by Celgene Corporation
Pomalidomide Adverse Events: High Seriousness and Diverse Reactions
136,988 FDA adverse event reports analyzed
Last updated: 2026-05-12
POMALIDOMIDE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Celgene Corporation. Based on analysis of 136,988 FDA adverse event reports, POMALIDOMIDE has a safety score of 82 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 POMALIDOMIDE include PLASMA CELL MYELOMA, DEATH, FATIGUE, PNEUMONIA, OFF LABEL USE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for POMALIDOMIDE.
Pomalidomide has a safety concern score of 82 out of 100, placing it in the high concern category based on analysis of FDA adverse event data. The FDA has received approximately 136,988 adverse event reports for this medication, which is primarily manufactured by Celgene Corporation.
The most commonly reported adverse events include Plasma Cell Myeloma, Death, Fatigue. Of classified reports, 61.6% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. High percentage of serious adverse events (61.6%) indicates significant safety concerns.
A wide range of reactions, including fatal outcomes, infections, and hematological issues, are reported. Frequent occurrences of hematological and respiratory issues suggest these as primary safety concerns.
Patients taking Pomalidomide should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Pomalidomide can cause severe hematological and respiratory issues, and patients should be monitored closely for these conditions. Drug interactions, particularly with other hematological agents, should be carefully managed. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Pomalidomide received a safety concern score of 82/100 (high concern). This is based on a 61.6% serious event ratio across 98,251 classified reports. The score accounts for 136,988 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: 49,156, Female: 45,823, Unknown: 59. The most frequently reported age groups are age 72 (2,671 reports), age 74 (2,570 reports), age 75 (2,556 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 98,251 classified reports for POMALIDOMIDE:
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.
Pomalidomide can cause severe hematological and respiratory issues, and patients should be monitored closely for these conditions. Drug interactions, particularly with other hematological agents, should be carefully managed.
If you are taking Pomalidomide, here are important things to know. The most commonly reported side effects include plasma cell myeloma, death, fatigue, pneumonia, off label use. 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. Regular blood tests and monitoring of hematological parameters are essential during treatment. 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.
Regulatory oversight is ongoing, with Pomalidomide requiring strict monitoring and reporting of adverse events. Healthcare providers should adhere to the prescribing information and guidelines.
The FDA has received approximately 136,988 adverse event reports associated with Pomalidomide. 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 Pomalidomide include Plasma Cell Myeloma, Death, Fatigue, Pneumonia, Off Label Use. By volume, the top reported reactions are: Plasma Cell Myeloma (7,851 reports), Death (7,465 reports), Fatigue (7,170 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Pomalidomide.
Out of 98,251 classified reports, 60,511 (61.6%) were classified as serious and 37,740 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 Pomalidomide break down by patient sex as follows: Male: 49,156, Female: 45,823, Unknown: 59. 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 Pomalidomide adverse events are: age 72: 2,671 reports, age 74: 2,570 reports, age 75: 2,556 reports, age 70: 2,549 reports, age 71: 2,513 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 Pomalidomide 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 Pomalidomide include: Diarrhoea, White Blood Cell Count Decreased, Neutropenia, Rash, Dyspnoea. 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 Pomalidomide 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.
Pomalidomide has a safety concern score of 82 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. High percentage of serious adverse events (61.6%) indicates significant safety concerns.
Key safety signals identified in Pomalidomide's adverse event data include: High number of fatalities reported.. Significant hematological issues such as decreased white blood cell count and thrombocytopenia.. Multiple respiratory issues including pneumonia and dyspnea.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Pomalidomide can cause severe hematological and respiratory issues, and patients should be monitored closely for these conditions. Drug interactions, particularly with other hematological agents, should be carefully managed. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Pomalidomide.
Patients should report any new or worsening symptoms to their healthcare provider immediately. Regular blood tests and monitoring of hematological parameters are essential during treatment.
Pomalidomide has 136,988 adverse event reports on file with the FDA. A wide range of reactions, including fatal outcomes, infections, and hematological issues, are reported. The volume of reports for Pomalidomide reflects both the drug's usage level and the vigilance of the reporting community.
Regulatory oversight is ongoing, with Pomalidomide requiring strict monitoring and reporting of adverse events. Healthcare providers should adhere to the prescribing information and guidelines. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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