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Xeloda Side Effects

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Common Xeloda Side Effects


The most commonly reported Xeloda side effects (click to view or check a box to report):

Diarrhoea (964)
Death (734)
Palmar-plantar Erythrodysaesthesia Syndrome (506)
Disease Progression (415)
Nausea (379)
Vomiting (358)
Dehydration (284)
Fatigue (186)
Mucosal Inflammation (182)
Asthenia (180)
Decreased Appetite (176)
Stomatitis (154)
Pyrexia (148)
Neutropenia (132)
Abdominal Pain (131)
Malignant Neoplasm Progression (119)
Dyspnoea (110)
Erythema (108)
Weight Decreased (102)
Sepsis (96)

➢ More



If you or someone in your family has experienced a serious side effect to a health product, you are encouraged to report the experience to your health care professional (e.g. physician, pharmacist). You could also complete a copy of the side effect reporting form or report your side effect to FDA.

Xeloda Side Effects Reported to FDA



Xeloda Side Effect Report#9999124
Vomiting, Nausea, Hypertension, Disease Progression, Disease Progression
This is a report of a 47-year-old female patient (weight: NA) from MX, suffering from the following health symptoms/conditions: colorectal cancer, who was treated with Xeloda (dosage: During 14 Days Of Treatment And 7 Days Of Rest?planned Cycles Of Treatment With Capecitabine: Indef, start time: NS), combined with:
  • Avastin
  • Oxaliplatin
and developed a serious reaction and side effect(s): Vomiting, Nausea, Hypertension, Disease Progression, Disease Progression after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Xeloda treatment in female patients, resulting in Vomiting side effect.
Xeloda Side Effect Report#9999101
Disease Progression, Disease Progression
This report suggests a potential Xeloda Disease Progression side effect(s) that can have serious consequences. A 83-year-old female patient (weight: NA) from MX was diagnosed with the following symptoms/conditions: breast cancer and used Xeloda (dosage: During 14 Days In A Cycle Of 21 Days) starting NS. After starting Xeloda the patient began experiencing various side effects, including: Disease Progression, Disease ProgressionAdditional drugs used concurrently: NA. Although Xeloda demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Disease Progression, may still occur.
Xeloda Side Effect Report#9999051
Nausea, Diarrhoea, Disease Progression
This Nausea problem was reported by a physician from MX. A 40-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: gastric cancer. On NS this consumer started treatment with Xeloda (dosage: Cycle 21 Days, 6 Cycles Programmed). The following drugs were being taken at the same time:
  • Epirubicin
  • Oxaliplatin
When using Xeloda, the patient experienced the following unwanted symptoms/side effects: Nausea, Diarrhoea, Disease ProgressionAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Nausea, may become evident only after a product is in use by the general population.
Xeloda Side Effect Report#9999025
Disease Progression
This Disease Progression side effect was reported by a physician from MX. A 52-year-old female patient (weight:NA) experienced the following symptoms/conditions: colorectal cancer.The patient was prescribed Xeloda (drug dosage: NA), which was initiated on NS. Concurrently used drugs:
  • Avastin (Planned Cycles Of Treatment: 4.)
  • Leucovorin
  • Fluoracilo
  • Irinotecan
.After starting to take Xeloda the consumer reported adverse symptoms, such as: Disease ProgressionThese side effects may potentially be related to Xeloda.
Xeloda Side Effect Report#9999015
Lethargy, Memory Impairment, Dehydration, Depression
This is a report of a 51-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: NA, who was treated with Xeloda (dosage: 2 Tablets Bid, start time:
Jan 01, 2014), combined with: NA. and developed a serious reaction and side effect(s): Lethargy, Memory Impairment, Dehydration, Depression after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Xeloda treatment in female patients, resulting in Lethargy side effect.
Xeloda Side Effect Report#9998996
Diarrhoea, Hypertension, Palmar-plantar Erythrodysaesthesia Syndrome, Nausea
This report suggests a potential Xeloda Diarrhoea side effect(s) that can have serious consequences. A 63-year-old male patient (weight: NA) from MX was diagnosed with the following symptoms/conditions: colorectal cancer and used Xeloda (dosage: During 14 Days Of Treatment And 7 Days Of Rest) starting NS. After starting Xeloda the patient began experiencing various side effects, including: Diarrhoea, Hypertension, Palmar-plantar Erythrodysaesthesia Syndrome, NauseaAdditional drugs used concurrently:
  • Avastin
  • Oxaliplatin
Although Xeloda demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Diarrhoea, may still occur.
Xeloda Side Effect Report#9998994
Nausea, Diarrhoea, Hypertension, Palmar-plantar Erythrodysaesthesia Syndrome
This Nausea problem was reported by a physician from MX. A 63-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: colorectal cancer. On NS this consumer started treatment with Xeloda (dosage: During 14 Days Of Treatment And 7 Days Of Rest). The following drugs were being taken at the same time:
  • Avastin
  • Oxaliplatin
When using Xeloda, the patient experienced the following unwanted symptoms/side effects: Nausea, Diarrhoea, Hypertension, Palmar-plantar Erythrodysaesthesia SyndromeAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Nausea, may become evident only after a product is in use by the general population.
Xeloda Side Effect Report#9998266
Paralysis, Speech Disorder
This Paralysis side effect was reported by a consumer or non-health professional from CL. A 40-year-old female patient (weight:NA) experienced the following symptoms/conditions: colon cancer.The patient was prescribed Xeloda (drug dosage: 14 Days Per Cycle, Last Dose Of Capecitabine Taken On 23/feb/2014), which was initiated on
Jan 01, 2014. Concurrently used drugs:
  • Oxaliplatin
  • Losartan
  • Aspirin
  • Atorvastatin
.After starting to take Xeloda the consumer reported adverse symptoms, such as: Paralysis, Speech DisorderThese side effects may potentially be related to Xeloda.
Xeloda Side Effect Report#9995545
Disease Progression, Disease Progression
This is a report of a 44-year-old female patient (weight: NA) from MX, suffering from the following health symptoms/conditions: breast cancer, who was treated with Xeloda (dosage: During 14 Days In A Cyclo Of 21 Days, start time: NS), combined with:
  • Cyclophosphamide
  • Adriamycin
and developed a serious reaction and side effect(s): Disease Progression, Disease Progression after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Xeloda treatment in female patients, resulting in Disease Progression side effect.
Xeloda Side Effect Report#9995435
Disease Progression, Anaemia, Diarrhoea
This report suggests a potential Xeloda Disease Progression side effect(s) that can have serious consequences. A 67-year-old female patient (weight: NA) from MX was diagnosed with the following symptoms/conditions: gastric cancer and used Xeloda (dosage: NA) starting NS. After starting Xeloda the patient began experiencing various side effects, including: Disease Progression, Anaemia, DiarrhoeaAdditional drugs used concurrently:
  • Docetaxel
  • Epirubicina
  • Oxaliplatino
Although Xeloda demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Disease Progression, may still occur.
Xeloda Side Effect Report#9994334
Disease Progression
This Disease Progression problem was reported by a physician from MX. A 52-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: colorectal cancer. On NS this consumer started treatment with Xeloda (dosage: NA). The following drugs were being taken at the same time:
  • Oxaliplatin
When using Xeloda, the patient experienced the following unwanted symptoms/side effects: Disease ProgressionAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Disease Progression, may become evident only after a product is in use by the general population.
Xeloda Side Effect Report#9994193
Back Pain, Inflammation
This Back Pain side effect was reported by a consumer or non-health professional from US. A female patient (weight:NA) experienced the following symptoms/conditions: pancreatic carcinoma.The patient was prescribed Xeloda (drug dosage: NA), which was initiated on
Jan 08, 2014. Concurrently used drugs: NA..After starting to take Xeloda the consumer reported adverse symptoms, such as: Back Pain, InflammationThese side effects may potentially be related to Xeloda. The patient was hospitalized.
Xeloda Side Effect Report#9994184
This is a report of a 51-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: breast cancer, who was treated with Xeloda (dosage: NA, start time:
Feb 06, 2014), combined with: NA. and developed a serious reaction and side effect(s): after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Xeloda treatment in female patients, resulting in Death side effect.
Xeloda Side Effect Report#9989368
Disease Progression
This report suggests a potential Xeloda Disease Progression side effect(s) that can have serious consequences. A 64-year-old female patient (weight: NA) from MX was diagnosed with the following symptoms/conditions: ovarian cancer and used Xeloda (dosage: NA) starting NS. After starting Xeloda the patient began experiencing various side effects, including: Disease ProgressionAdditional drugs used concurrently:
  • Carboplatin
Although Xeloda demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Disease Progression, may still occur.
Xeloda Side Effect Report#9988345
Disease Progression
This Disease Progression problem was reported by a consumer or non-health professional from CL. A 99-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: breast cancer. On
Aug 27, 2013 this consumer started treatment with Xeloda (dosage: 14-day-cycle). The following drugs were being taken at the same time: NA. When using Xeloda, the patient experienced the following unwanted symptoms/side effects: Disease ProgressionAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Disease Progression, may become evident only after a product is in use by the general population.
Xeloda Side Effect Report#9988303
Intestinal Obstruction, Gastrointestinal Stoma Complication
This Intestinal Obstruction side effect was reported by a consumer or non-health professional from CL. A 56-year-old male patient (weight:NA) experienced the following symptoms/conditions: rectal cancer.The patient was prescribed Xeloda (drug dosage: 14-day-cycle), which was initiated on
Feb 10, 2014. Concurrently used drugs: NA..After starting to take Xeloda the consumer reported adverse symptoms, such as: Intestinal Obstruction, Gastrointestinal Stoma ComplicationThese side effects may potentially be related to Xeloda. The patient was hospitalized.
Xeloda Side Effect Report#9988263
This is a report of a 84-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: small intestine carcinoma, who was treated with Xeloda (dosage: NA, start time:
Feb 01, 2014), combined with:
  • Aspirin
  • Lisinopril
  • Maxidex
  • Toprol
  • Potassium Chloride
and developed a serious reaction and side effect(s): after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Xeloda treatment in female patients, resulting in Death side effect.
Xeloda Side Effect Report#9988050
Disease Progression
This report suggests a potential Xeloda Disease Progression side effect(s) that can have serious consequences. A 49-year-old male patient (weight: NA) from CL was diagnosed with the following symptoms/conditions: colon cancer and used Xeloda (dosage: 14-day-cycle) starting
Dec 28, 2013. After starting Xeloda the patient began experiencing various side effects, including: Disease ProgressionAdditional drugs used concurrently: NA. Although Xeloda demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Disease Progression, may still occur.
Xeloda Side Effect Report#9988045
This Death problem was reported by a physician from US. A 75-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: colon cancer. On
Oct 25, 2013 this consumer started treatment with Xeloda (dosage: NA). The following drugs were being taken at the same time: NA. When using Xeloda, the patient experienced the following unwanted symptoms/side effects:Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Death, may become evident only after a product is in use by the general population.
Xeloda Side Effect Report#9981157
Metastases To Lung
This Metastases To Lung side effect was reported by a consumer or non-health professional from CN. A 81-year-old female patient (weight:NA) experienced the following symptoms/conditions: rectal cancer.The patient was prescribed Xeloda (drug dosage: NA), which was initiated on 201310. Concurrently used drugs: NA..After starting to take Xeloda the consumer reported adverse symptoms, such as: Metastases To LungThese side effects may potentially be related to Xeloda.
Xeloda Side Effect Report#9980746
Tumour Excision
This is a report of a male patient (weight: NA) from US, suffering from the following health symptoms/conditions: oesophageal carcinoma, who was treated with Xeloda (dosage: 2 Tablets Twice Daily, start time:
Aug 23, 2013), combined with: NA. and developed a serious reaction and side effect(s): Tumour Excision after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Xeloda treatment in male patients, resulting in Tumour Excision side effect. The patient was hospitalized.
Xeloda Side Effect Report#9980707
Disease Progression
This report suggests a potential Xeloda Disease Progression side effect(s) that can have serious consequences. A 56-year-old female patient (weight: NA) from MX was diagnosed with the following symptoms/conditions: breast cancer and used Xeloda (dosage: 8 Cycles Programmed, 14 Aplications Per Cycle) starting NS. After starting Xeloda the patient began experiencing various side effects, including: Disease ProgressionAdditional drugs used concurrently: NA. Although Xeloda demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Disease Progression, may still occur.
Xeloda Side Effect Report#9980632
Disease Progression, Vomiting
This Disease Progression problem was reported by a physician from MX. A 73-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: colorectal cancer. On NS this consumer started treatment with Xeloda (dosage: NA). The following drugs were being taken at the same time:
  • Oxaliplatin
  • Irinotecan
  • 5-fu
  • Leucovorin
When using Xeloda, the patient experienced the following unwanted symptoms/side effects: Disease Progression, VomitingAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Disease Progression, may become evident only after a product is in use by the general population.
Xeloda Side Effect Report#9980323
Infusion Related Reaction, Interstitial Lung Disease, Sinusitis, Hepatic Function Abnormal, Myalgia
This Infusion Related Reaction side effect was reported by a physician from JP. A 58-year-old female patient (weight:NA) experienced the following symptoms/conditions: rectal cancer recurrent.The patient was prescribed Xeloda (drug dosage: It Is One Administering Weekly Holiday Medicine For Two Weeks.), which was initiated on
Sep 25, 2013. Concurrently used drugs: NA..After starting to take Xeloda the consumer reported adverse symptoms, such as: Infusion Related Reaction, Interstitial Lung Disease, Sinusitis, Hepatic Function Abnormal, MyalgiaThese side effects may potentially be related to Xeloda. The patient was hospitalized.
Xeloda Side Effect Report#9979185
Convulsion, Brain Oedema, Dizziness
This is a report of a 48-year-old female patient (weight: NA) from CL, suffering from the following health symptoms/conditions: breast cancer, who was treated with Xeloda (dosage: 14 Days Per Cycle, start time:
May 16, 2013), combined with:
  • Herceptin
and developed a serious reaction and side effect(s): Convulsion, Brain Oedema, Dizziness after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Xeloda treatment in female patients, resulting in Convulsion side effect.


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The appearance of Xeloda on this list does not mean that FDA has concluded that the drug has the listed risk. It means that FDA has identified a potential safety issue, but it does not mean that FDA has found a causal relationship between the drug and the listed risk.

What are common Xeloda Side Effects for Women?

Women Side EffectsReports
Diarrhoea 599
Death 389
Palmar-plantar Erythrodysaesthesia Syndrome 349
Disease Progression 262
Nausea 249
Vomiting 244
Dehydration 174
Fatigue 126
Asthenia 115
Decreased Appetite 108

What are common Xeloda Side Effects for Men?

Men Side EffectsReports
Diarrhoea 343
Death 286
Palmar-plantar Erythrodysaesthesia Syndrome 145
Nausea 126
Disease Progression 123
Vomiting 109
Dehydration 107
Mucosal Inflammation 79
Decreased Appetite 66
Asthenia 61

Track Your Side Effects

Note Your Observations

It is really important to keep track of your health symptoms, right from the time you start a new medicine. You can do it any way you prefer: in a notebook, in a computer file or using our online tool. You should also note down any other medicines you are taking at the same time, because there could be an interaction between these medicines.

Why Your Notes are Important

Your notes could be helpful in several ways:

  • You can use them to remind you of details that may alert your health care professional(s) to a problem
  • You will have a record to refer to in the future, in case you are ever prescribed the same medicine again

  • Log Form

    You can use the following log form to write down important information, like the date and time you experienced a side effect and your symptoms, how strong the symptoms were, and any other medicines you were using.

    Medicine Name and Dosage:
    Side Effects Scale Date & Time Other Medicine(s) or Treatment(s)
    Scale: 1 = very mild to 10 = very bad

    Side effects reports are analyzed to discover potential health product safety signals. Some important reactions may take an extremely long time to develop or occur infrequently. Continued monitoring of adverse reactions is thus essential to maintain a comprehensive safety and effectiveness profile of health products.

    You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

    Xeloda reports list potential signals of serious risks and new safety information that were identified using the FDA Adverse Event Reporting System (FAERS).
    FAERS is a database that contains information on adverse event and medication errors reports submitted to FDA by healthcare professionals (such as physicians, pharmacists, nurses and others), consumers (such as patients, family members, layers and others) and manufacturers.

    Discuss Xeloda Side Effects

    Did You Have a Xeloda Side Effect?

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    How Effective is Xeloda for You?

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    Xeloda Safety Alerts, Active Ingredients, Usage Information

    NDC0004-1100
    TypeHUMAN PRESCRIPTION DRUG
    Proprietary NameXeloda
    Namecapecitabine
    Dosage FormTABLET, FILM COATED
    RouteORAL
    On market since19980430
    LabelerGenentech, Inc.
    Active Ingredient(s)CAPECITABINE
    Strength(s)150
    Unit(s)mg/1
    Pharma ClassNucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC]

    Xeloda Dosage, Warnings, Usage.

    Side Effects reported to FDA: 5241

    Xeloda safety alerts: 2001 2000

    Reported deaths: 2075

    Reported hospitalizations: 2294

    Xeloda (capecitabine)

    Audience: Oncologists, Pharmacists, and other healthcare professionals

    FDA and Roche have added a BLACK BOX WARNING and strengthened the PRECAUTIONS section in the label for Xeloda, indicated for the treatment of colorectal and breast cancer. A clinically important XELODA-Warfarin drug interaction was demonstrated in a clinical pharmacology trial. Postmarketing reports have shown clinically significant increases in prothrombin time and INR in patients who were stabilized on anticoagulants at the time XELODA was introduced. Patients receiving concomitant capecitabine and oral coumarin-derivative anticoagulant therapy should have their anticoagulant response (INR or prothrombin time) monitored frequently in order to adjust the anticoagulant dose accordingly. The Patient Package Insert was also revised to reflect this new safety information.

     

    Latest Xeloda clinical trials