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Capecitabine Side Effects

The most commonly reported side effects of capecitabine include diarrhoea, nausea, and death, based on 96,633 FDA adverse event reports from 2004 to 2025. 2.6% of reports found the drug to be ineffective.

Capecitabine side effects

Percentages show how often each reaction appears relative to total reports for capecitabine.

1
Diarrhoea11.6%11,241
2
Nausea7.9%7,591
3
Death7.7%7,432
4
Fatigue6.3%6,117
5
Palmar-plantar Erythrodysaesthesia Syndrome6.3%6,044
6
Disease Progression5.5%5,286
7
Vomiting5.3%5,139
8
Off Label Use4.1%3,960
9
Malignant Neoplasm Progression3.4%3,248
10
Diarrhoea3.2%3,121
11
Decreased Appetite3.1%2,962
12
Asthenia3.0%2,933
13
Neuropathy Peripheral2.8%2,729
14
Neutropenia2.7%2,591
15
Drug Ineffective2.6%2,554

These are voluntary reports and do not establish that capecitabine caused these reactions.

Report severity

78.6%Serious75,961 reports
31.0%Hospitalizations29,926 reports
19.3%Fatal18,637 reports

Seriousness is determined by the reporter, not by OpenClaim.

Capecitabine drug interactions

Other drugs that appear in adverse event reports alongside capecitabine. Drugs flagged as a suspected cause appear in the first column. Drugs taken at the same time but not suspected appear in the second.

Also suspected

1
Oxaliplatin15.8%15,271
2
Bevacizumab12.1%11,695
3
Trastuzumab8.8%8,503
4
Lapatinib-ditosylate6.0%5,761
5
Paclitaxel4.3%4,177
6
Fluorouracil3.9%3,807
7
Docetaxel3.9%3,764
8
Tucatinib3.7%3,571
9
Irinotecan-hydrochloride3.4%3,314
10
Cisplatin3.2%3,103
11
Gemcitabine3.1%2,956
12
Epirubicin-hydrochloride2.5%2,393
13
Vinorelbine-tartrate2.3%2,227
14
Letrozole2.2%2,081
15
Pertuzumab2.0%1,968

Taken alongside

1
Ondansetron5.0%4,796
2
Acetaminophen4.7%4,500
3
Dexamethasone4.4%4,227
4
Oxaliplatin3.8%3,657
5
Omeprazole3.1%2,998
6
Aspirin2.6%2,492
7
Loperamide-hydrochloride2.6%2,466
8
Levothyroxine-sodium2.5%2,439
9
Oxycodone2.4%2,302
10
Amlodipine2.3%2,204
11
Pantoprazole-sodium2.2%2,131
12
Ergocalciferol2.2%2,125
13
Prochlorperazine2.2%2,117
14
Atorvastatin-calcium2.1%1,990
15
Furosemide2.0%1,924

Co-occurrence in adverse event reports does not establish a drug interaction. Patients often take multiple medications, and these lists reflect prescribing patterns rather than causal relationships. Consult a healthcare provider about potential drug interactions.

Who reports capecitabine side effects

58.4% of capecitabine adverse event reports involve female patients and 32.2% involve male patients. The largest age group is adult at 56%. These figures reflect who reports side effects, not underlying risk.

Sex

Female58.4%
Male32.2%
Unknown9.4%

Age group

< 2<0.1%
2–11<0.1%
12–170.1%
18–6456.2%
65+43.5%

What is capecitabine used for

Conditions and purposes for which patients were taking capecitabine when the adverse event was reported.

Abdominal DistensionAbdominal MassAbdominal NeoplasmAbdominal PainAbnormal Weight GainAccidental Drug Intake By ChildAcinar Cell Carcinoma Of PancreasActh-producing Pituitary TumourActh-producing Pituitary TumourActinic KeratosisAcute Kidney InjuryAcute Lymphocytic LeukaemiaAcute Myeloid LeukaemiaAcute Myocardial InfarctionAdenocarcinoma

Showing 15 of 1,319 indications

Capecitabine brand names and reporting trend

Capecitabine is sold under the brand name Capecitabine.

Brand names

Capecitabine73,266

Quarterly reports (20042025)

20052010201520202025

An upward trend reflects increased FAERS reporting overall, not necessarily increased risk.

Taking capecitabine with another medication?

Ask OpenClaim about your specific drug combination. Get a sourced report using FDA data, drug labels, and medical literature.