85/100 · Critical
Manufactured by H2-Pharma, LLC
Severe Adverse Reactions Common with Capecitabine Use
174,965 FDA adverse event reports analyzed
Last updated: 2026-05-12
CAPECITABINE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by H2-Pharma, LLC. Based on analysis of 174,965 FDA adverse event reports, CAPECITABINE 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 CAPECITABINE include DIARRHOEA, DEATH, NAUSEA, PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME, FATIGUE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for CAPECITABINE.
Capecitabine 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 174,965 adverse event reports for this medication, which is primarily manufactured by H2-Pharma, Llc.
The most commonly reported adverse events include Diarrhoea, Death, Nausea. Of classified reports, 82.2% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Severe adverse reactions such as death, disease progression, and sepsis are frequently reported.
Diarrhoea and nausea are the most common gastrointestinal side effects. Neutropenia and thrombocytopenia are significant hematological concerns.
Patients taking Capecitabine should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Capecitabine can cause severe hematological and gastrointestinal side effects, and patients should be monitored closely for signs of toxicity. Drug interactions, particularly with other cytotoxic agents, should be avoided. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Capecitabine received a safety concern score of 85/100 (high concern). This is based on a 82.2% serious event ratio across 88,887 classified reports. The score accounts for 174,965 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: Female: 51,525, Male: 28,494, Unknown: 542. The most frequently reported age groups are age 65 (1,724 reports), age 66 (1,714 reports), age 70 (1,682 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 88,887 classified reports for CAPECITABINE:
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.
Capecitabine can cause severe hematological and gastrointestinal side effects, and patients should be monitored closely for signs of toxicity. Drug interactions, particularly with other cytotoxic agents, should be avoided.
If you are taking Capecitabine, here are important things to know. The most commonly reported side effects include diarrhoea, death, nausea, palmar-plantar erythrodysaesthesia syndrome, fatigue. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Monitor closely for signs of severe side effects such as severe diarrhea, nausea, and hematological issues. Follow healthcare provider’s guidance on managing side effects and adjusting dosages as necessary. 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 frequent updates to the drug’s labeling to include new safety information. Patients should report any adverse reactions immediately.
The FDA has received approximately 174,965 adverse event reports associated with Capecitabine. 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 Capecitabine include Diarrhoea, Death, Nausea, Palmar-Plantar Erythrodysaesthesia Syndrome, Fatigue. By volume, the top reported reactions are: Diarrhoea (13,395 reports), Death (8,723 reports), Nausea (8,248 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Capecitabine.
Out of 88,887 classified reports, 73,050 (82.2%) were classified as serious and 15,837 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 Capecitabine break down by patient sex as follows: Female: 51,525, Male: 28,494, Unknown: 542. 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 Capecitabine adverse events are: age 65: 1,724 reports, age 66: 1,714 reports, age 70: 1,682 reports, age 67: 1,640 reports, age 60: 1,629 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 Capecitabine adverse event reports is H2-Pharma, Llc. 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 Capecitabine include: Vomiting, Disease Progression, Malignant Neoplasm Progression, Off Label Use, Asthenia. 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 Capecitabine 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.
Capecitabine 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. Severe adverse reactions such as death, disease progression, and sepsis are frequently reported.
Key safety signals identified in Capecitabine's adverse event data include: High incidence of serious adverse reactions (82.2%). Diverse range of reactions including neurological, gastrointestinal, and hematological issues. Significant number of reports involving disease progression and metastasis. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Capecitabine can cause severe hematological and gastrointestinal side effects, and patients should be monitored closely for signs of toxicity. Drug interactions, particularly with other cytotoxic agents, should be avoided. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Capecitabine.
Monitor closely for signs of severe side effects such as severe diarrhea, nausea, and hematological issues. Follow healthcare provider’s guidance on managing side effects and adjusting dosages as necessary.
Capecitabine has 174,965 adverse event reports on file with the FDA. Diarrhoea and nausea are the most common gastrointestinal side effects. The volume of reports for Capecitabine reflects both the drug's usage level and the vigilance of the reporting community.
Regulatory oversight is ongoing, with frequent updates to the drug’s labeling to include new safety information. Patients should report any adverse reactions immediately. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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