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Capecitabine Side Effects

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Common Capecitabine Side Effects


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

Diarrhoea (965)
Death (539)
Dehydration (436)
Vomiting (420)
Disease Progression (367)
Nausea (366)
Malignant Neoplasm Progression (352)
Mucosal Inflammation (276)
Palmar-plantar Erythrodysaesthesia Syndrome (243)
Abdominal Pain (197)
Pyrexia (190)
Fatigue (174)
Febrile Neutropenia (170)
Asthenia (166)
Dyspnoea (161)
Neutropenia (153)
Intestinal Obstruction (142)
Sepsis (132)
Anaemia (128)
Pulmonary Embolism (124)

➢ 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.

Capecitabine Side Effects Reported to FDA



Capecitabine Side Effect Report#9994619
Dehydration, Malaise, Pulmonary Embolism
This is a report of a 76-year-old male patient (weight: NA) from NL, suffering from the following health symptoms/conditions: gastric cancer, who was treated with Capecitabine (dosage: Most Recent Dose On 27/feb/2014, start time:
Jan 24, 2014), combined with:
  • Epirubicin (Most Recent Dose On 19/feb/2014)
  • Cisplatin (Most Recent Dose On 19/feb/2014)
and developed a serious reaction and side effect(s): Dehydration, Malaise, Pulmonary Embolism after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Capecitabine treatment in male patients, resulting in Dehydration side effect. The patient was hospitalized.
Capecitabine Side Effect Report#9969329
Azotaemia
This report suggests a potential Capecitabine Azotaemia side effect(s) that can have serious consequences. A 52-year-old female patient (weight: NA) from CO was diagnosed with the following symptoms/conditions: colorectal cancer metastatic and used Capecitabine (dosage: NA) starting NS. After starting Capecitabine the patient began experiencing various side effects, including: AzotaemiaAdditional drugs used concurrently: NA.The patient was hospitalized. Although Capecitabine demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Azotaemia, may still occur.
Capecitabine Side Effect Report#9968763
Throat Tightness, Loss Of Control Of Legs, Paraesthesia, Wheezing
This Throat Tightness problem was reported by a health professional from AU. A 73-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On
Dec 02, 2013 this consumer started treatment with Capecitabine (dosage: NA). The following drugs were being taken at the same time:
  • Aspirin
  • Atorvastatin
  • Oxaliplatin
  • Panadol Osteo
  • Zanextra
When using Capecitabine, the patient experienced the following unwanted symptoms/side effects: Throat Tightness, Loss Of Control Of Legs, Paraesthesia, WheezingAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Throat Tightness, may become evident only after a product is in use by the general population.
Capecitabine Side Effect Report#9956387
Disease Progression
This Disease Progression side effect was reported by a consumer or non-health professional from CO. A 75-year-old male patient (weight:NA) experienced the following symptoms/conditions: gastric cancer.The patient was prescribed Capecitabine (drug dosage: NA), which was initiated on
Aug 28, 2013. Concurrently used drugs: NA..After starting to take Capecitabine the consumer reported adverse symptoms, such as: Disease ProgressionThese side effects may potentially be related to Capecitabine.
Capecitabine Side Effect Report#9956357
Disease Progression
This is a report of a 83-year-old female patient (weight: NA) from CO, suffering from the following health symptoms/conditions: colon cancer metastatic, who was treated with Capecitabine (dosage: NA, start time:
Jul 19, 2013), combined with: NA. and developed a serious reaction and side effect(s): Disease Progression after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Capecitabine treatment in female patients, resulting in Disease Progression side effect.
Capecitabine Side Effect Report#9937375
Peripheral Arterial Occlusive Disease
This report suggests a potential Capecitabine Peripheral Arterial Occlusive Disease side effect(s) that can have serious consequences. A 56-year-old male patient (weight: NA) from NL was diagnosed with the following symptoms/conditions: gastric cancer and used Capecitabine (dosage: Date Of Last Dose Of Capecitabine: 05/feb/2014) starting
Jan 15, 2014. After starting Capecitabine the patient began experiencing various side effects, including: Peripheral Arterial Occlusive DiseaseAdditional drugs used concurrently:
  • Epirubicin (Date Of Last Dose Of Epirubicin: 05/feb/2014)
  • Cisplatin (Date Of Last Dose Of Cisplatin: 05/feb/2014)
The patient was hospitalized. Although Capecitabine demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Peripheral Arterial Occlusive Disease, may still occur.
Capecitabine Side Effect Report#9924455
Stevens-johnson Syndrome, Lower Respiratory Tract Infection, Dysphagia, Pyrexia, Stomatitis, Neutropenia, Oesophagitis, Dyspnoea, Rash
This Stevens-johnson Syndrome problem was reported by a physician from GB. A 28-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: breast cancer metastatic. On
Sep 11, 2013 this consumer started treatment with Capecitabine (dosage: NA). The following drugs were being taken at the same time: NA. When using Capecitabine, the patient experienced the following unwanted symptoms/side effects: Stevens-johnson Syndrome, Lower Respiratory Tract Infection, Dysphagia, Pyrexia, Stomatitis, Neutropenia, Oesophagitis, Dyspnoea, RashThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Stevens-johnson Syndrome, may become evident only after a product is in use by the general population.
Capecitabine Side Effect Report#9924350
Recall Phenomenon
This Recall Phenomenon side effect was reported by a health professional from ES. A 78-year-old female patient (weight:NA) experienced the following symptoms/conditions: breast cancer.The patient was prescribed Capecitabine (drug dosage: NA), which was initiated on 201005. Concurrently used drugs: NA..After starting to take Capecitabine the consumer reported adverse symptoms, such as: Recall PhenomenonThese side effects may potentially be related to Capecitabine.
Capecitabine Side Effect Report#9919649
Arteriospasm Coronary
This is a report of a 63-year-old male patient (weight: NA) from DE, suffering from the following health symptoms/conditions: rectal cancer metastatic, who was treated with Capecitabine (dosage: 3000 Milligram Daily;, start time: NS), combined with:
  • Oxaliplatin
and developed a serious reaction and side effect(s): Arteriospasm Coronary after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Capecitabine treatment in male patients, resulting in Arteriospasm Coronary side effect.
Capecitabine Side Effect Report#9913236
Keratitis, Diarrhoea
This report suggests a potential Capecitabine Keratitis side effect(s) that can have serious consequences. A 78-year-old female patient (weight: NA) from GT was diagnosed with the following symptoms/conditions: colon cancer and used Capecitabine (dosage: NA) starting
Dec 01, 2011. After starting Capecitabine the patient began experiencing various side effects, including: Keratitis, DiarrhoeaAdditional drugs used concurrently:
  • Bevacizumab
Although Capecitabine demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Keratitis, may still occur.
Capecitabine Side Effect Report#9913185
Disease Progression
This Disease Progression problem was reported by a consumer or non-health professional from CO. A 53-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: colon cancer. On
Aug 09, 2013 this consumer started treatment with Capecitabine (dosage: NA). The following drugs were being taken at the same time:
  • Bevacizumab
When using Capecitabine, the patient experienced the following unwanted symptoms/side effects: Disease ProgressionThe patient was hospitalized.Although 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.
Capecitabine Side Effect Report#9912608
Diarrhoea, Pulmonary Fibrosis, Dehydration, Sepsis
This Diarrhoea side effect was reported by a physician from US. A 78-year-old male patient (weight:NA) experienced the following symptoms/conditions: transitional cell carcinoma.The patient was prescribed Capecitabine (drug dosage: NA), which was initiated on NS. Concurrently used drugs: NA..After starting to take Capecitabine the consumer reported adverse symptoms, such as: Diarrhoea, Pulmonary Fibrosis, Dehydration, SepsisThese side effects may potentially be related to Capecitabine.
Capecitabine Side Effect Report#9907573
Pulmonary Fibrosis, Infection
This is a report of a 74-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: transitional cell carcinoma, who was treated with Capecitabine (dosage: 2 Divided Doses Daily For 1 Week, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Pulmonary Fibrosis, Infection after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Capecitabine treatment in female patients, resulting in Pulmonary Fibrosis side effect. The patient was hospitalized.
Capecitabine Side Effect Report#9900228
Neoplasm Progression
This report suggests a potential Capecitabine Neoplasm Progression side effect(s) that can have serious consequences. A 55-year-old female patient (weight: NA) from CO was diagnosed with the following symptoms/conditions: gastric cancer and used Capecitabine (dosage: NA) starting
Nov 05, 2013. After starting Capecitabine the patient began experiencing various side effects, including: Neoplasm ProgressionAdditional drugs used concurrently: NA. Although Capecitabine demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Neoplasm Progression, may still occur.
Capecitabine Side Effect Report#9886119
Inflammation, C-reactive Protein Increased, Renal Failure, Dehydration
This Inflammation problem was reported by a physician from BE. A 83-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: her-2 positive gastric cancer. On
Dec 04, 2013 this consumer started treatment with Capecitabine (dosage: 100 Mg, 2 In 1 Day). The following drugs were being taken at the same time:
  • 5-fluorouracil (6936 Mg, 1 In 3 Weeks)
  • Cisplatin (139 Mg, 1 In 3 Week)
  • Pertuzumab (Unk Ukn, Unk)
  • Trastuzumab (533 Mg, 1 In 3 Week)
  • Lisinopril (2.5 Mg, Unk)
  • Pantomed//pantoprazole Sodium Sesquihydrate (40 Mg, Unk)
  • Glucophage (Unk Ukn, Unk)
  • Tenormin (50 Mg, Unk)
When using Capecitabine, the patient experienced the following unwanted symptoms/side effects: Inflammation, C-reactive Protein Increased, Renal Failure, DehydrationThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Inflammation, may become evident only after a product is in use by the general population.
Capecitabine Side Effect Report#9882947
Cardiac Disorder
This Cardiac Disorder side effect was reported by a physician from NO. A 52-year-old female patient (weight:NA) experienced the following symptoms/conditions: breast cancer metastatic.The patient was prescribed Capecitabine (drug dosage: NA), which was initiated on
Jan 11, 2011. Concurrently used drugs:
  • Lapatinib
.After starting to take Capecitabine the consumer reported adverse symptoms, such as: Cardiac DisorderThese side effects may potentially be related to Capecitabine.
Capecitabine Side Effect Report#9880397
Dermatomyositis
This is a report of a 76-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: adenocarcinoma gastric, who was treated with Capecitabine (dosage: NA, start time: NS), combined with:
  • Carboplatin
and developed a serious reaction and side effect(s): Dermatomyositis after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Capecitabine treatment in male patients, resulting in Dermatomyositis side effect. The patient was hospitalized.
Capecitabine Side Effect Report#9880280
Diarrhoea, Sepsis, Prerenal Failure, Malignant Neoplasm Progression, Venous Thrombosis Limb
This report suggests a potential Capecitabine Diarrhoea side effect(s) that can have serious consequences. A 51-year-old male patient (weight: NA) from DE was diagnosed with the following symptoms/conditions: colorectal cancer metastatic and used Capecitabine (dosage: NA) starting 201304. After starting Capecitabine the patient began experiencing various side effects, including: Diarrhoea, Sepsis, Prerenal Failure, Malignant Neoplasm Progression, Venous Thrombosis LimbAdditional drugs used concurrently: NA. Although Capecitabine demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Diarrhoea, may still occur.
Capecitabine Side Effect Report#9876376
Abdominal Pain, Disease Recurrence
This Abdominal Pain problem was reported by a health professional from US. A 50-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On NS this consumer started treatment with Capecitabine (dosage: NA). The following drugs were being taken at the same time:
  • Gemcitabine Hydrochloride
When using Capecitabine, the patient experienced the following unwanted symptoms/side effects: Abdominal Pain, Disease RecurrenceThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Abdominal Pain, may become evident only after a product is in use by the general population.
Capecitabine Side Effect Report#9844286
Duodenal Perforation, Necrosis, Abdominal Infection
This Duodenal Perforation side effect was reported by a physician from NL. A 47-year-old patient (weight:NA) experienced the following symptoms/conditions: gastric cancer.The patient was prescribed Capecitabine (drug dosage: Most Recent Dose Received On 26/aug/2013), which was initiated on
Dec 11, 2013. Concurrently used drugs:
  • Epirubicin (Most Recent Dose Received On 13/aug/2013)
  • Cisplatin (Most Recent Dose Received On 13/aug/2013)
  • Esomeprazole
  • Vancomycin
.After starting to take Capecitabine the consumer reported adverse symptoms, such as: Duodenal Perforation, Necrosis, Abdominal InfectionThese side effects may potentially be related to Capecitabine. The patient was hospitalized.
Capecitabine Side Effect Report#9844103
Respiratory Failure, Bradycardia, Hypotension, Altered State Of Consciousness
This is a report of a 62-year-old male patient (weight: NA) from TW, suffering from the following health symptoms/conditions: colorectal cancer metastatic, who was treated with Capecitabine (dosage: NA, start time:
Nov 10, 2011), combined with: NA. and developed a serious reaction and side effect(s): Respiratory Failure, Bradycardia, Hypotension, Altered State Of Consciousness after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Capecitabine treatment in male patients, resulting in Respiratory Failure side effect. The patient was hospitalized.
Capecitabine Side Effect Report#9831057
Myelodysplastic Syndrome
This report suggests a potential Capecitabine Myelodysplastic Syndrome side effect(s) that can have serious consequences. A 69-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: skin cancer and used Capecitabine (dosage: NA) starting NS. After starting Capecitabine the patient began experiencing various side effects, including: Myelodysplastic SyndromeAdditional drugs used concurrently:
  • Azathioprine
  • Aspirin
  • Enalapril
  • Prednisone
  • Simvastatin
  • Tamsulosin
Although Capecitabine demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Myelodysplastic Syndrome, may still occur.
Capecitabine Side Effect Report#9825253
Sepsis, Multi-organ Failure, Anastomotic Leak
This Sepsis problem was reported by a physician from NL. A 62-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: gastrooesophageal cancer. On
Nov 08, 2013 this consumer started treatment with Capecitabine (dosage: Last Treatment Was On 30/nov/2013. Cumulative Dose 86400 Mg). The following drugs were being taken at the same time:
  • Epirubicin (Last Treatment Was On 25/nov/2013. Cumulative Dose: 226 Mg)
  • Cisplatin (Last Treatment Was On 25/nov/2013. Cumulative Dose: 216 Mg)
  • Paracetamol
  • Emend
  • Emend
When using Capecitabine, the patient experienced the following unwanted symptoms/side effects: Sepsis, Multi-organ Failure, Anastomotic LeakAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Sepsis, may become evident only after a product is in use by the general population.
Capecitabine Side Effect Report#9814980
This Death side effect was reported by a consumer or non-health professional from US. A 44-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Capecitabine (drug dosage: NA), which was initiated on NS. Concurrently used drugs: NA..After starting to take Capecitabine the consumer reported adverse symptoms, such as: These side effects may potentially be related to Capecitabine.
Capecitabine Side Effect Report#9812278
Mucosal Inflammation, Rectal Haemorrhage, Febrile Neutropenia
This is a report of a 72-year-old male patient (weight: NA) from NL, suffering from the following health symptoms/conditions: gastric cancer, who was treated with Capecitabine (dosage: NA, start time:
Nov 28, 2013), combined with:
  • Epirubicin
  • Cisplatin (Every 3 Weeks, Every 1 Week And 5 Weeks)
and developed a serious reaction and side effect(s): Mucosal Inflammation, Rectal Haemorrhage, Febrile Neutropenia after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Capecitabine treatment in male patients, resulting in Mucosal Inflammation side effect. The patient was hospitalized.


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The appearance of Capecitabine 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 Capecitabine Side Effects for Women?

Women Side EffectsReports
Diarrhoea 563
Death 296
Dehydration 260
Malignant Neoplasm Progression 253
Disease Progression 246
Vomiting 241
Nausea 214
Mucosal Inflammation 192
Palmar-plantar Erythrodysaesthesia Syndrome 170
Febrile Neutropenia 125

What are common Capecitabine Side Effects for Men?

Men Side EffectsReports
Diarrhoea 381
Death 234
Dehydration 167
Vomiting 162
Nausea 138
Disease Progression 120
Malignant Neoplasm Progression 94
Mucosal Inflammation 81
Abdominal Pain 78
Pyrexia 76

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.

    Capecitabine 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 Capecitabine Side Effects

    Did You Have a Capecitabine Side Effect?

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    How Effective is Capecitabine for You?

    Exceeded Expectations
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    Capecitabine Safety Alerts, Active Ingredients, Usage Information

    NDC0093-7473
    TypeHUMAN PRESCRIPTION DRUG
    Proprietary NameCapecitabine
    NameCapecitabine
    Dosage FormTABLET, FILM COATED
    RouteORAL
    On market since20140307
    LabelerTeva Pharmaceuticals USA Inc
    Active Ingredient(s)CAPECITABINE
    Strength(s)150
    Unit(s)mg/1
    Pharma ClassNucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC]

    More About Capecitabine

    Side Effects reported to FDA: 5490

    Capecitabine safety alerts: 2001 2000

    Reported deaths: 2032

    Reported hospitalizations: 3592

    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 Capecitabine clinical trials