CAPECITABINE: 63,506 Adverse Event Reports & Safety Profile

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63,506

Total FAERS Reports

8,892 (14.0%)

Deaths Reported

17,529

Hospitalizations

63,506

As Primary/Secondary Suspect

2,289

Life-Threatening

654

Disabilities

Apr 17, 2018

FDA Approved

Aurobindo Pharma Limited

Manufacturer

Discontinued

Status

Yes

Generic Available

Drug Class: Nucleic Acid Synthesis Inhibitors [MoA] · Route: ORAL · Manufacturer: Aurobindo Pharma Limited · FDA Application: 020896 · HUMAN PRESCRIPTION DRUG · FDA Label: Available

First Report: 10220301 · Latest Report: 20250926

What Are the Most Common CAPECITABINE Side Effects?

#1 Most Reported

Diarrhoea

9,277 reports (14.6%)

#2 Most Reported

Nausea

6,248 reports (9.8%)

#3 Most Reported

Palmar-plantar erythrodysaesthesia syndrome

5,294 reports (8.3%)

All CAPECITABINE Side Effects by Frequency

Side Effect	Reports	% of Total	Deaths	Hosp.
Diarrhoea	9,277	14.6%	988	3,297
Nausea	6,248	9.8%	562	1,762
Palmar-plantar erythrodysaesthesia syndrome	5,294	8.3%	312	808
Fatigue	5,018	7.9%	480	1,091
Death	4,422	7.0%	4,340	285
Vomiting	4,111	6.5%	524	1,682
Disease progression	3,808	6.0%	829	460
Off label use	3,193	5.0%	527	799
Malignant neoplasm progression	2,425	3.8%	461	403
Asthenia	2,352	3.7%	379	881
Decreased appetite	2,275	3.6%	304	721
Neuropathy peripheral	2,202	3.5%	181	372
Drug ineffective	2,136	3.4%	262	315
Neutropenia	2,086	3.3%	388	537
Thrombocytopenia	1,723	2.7%	336	495
Dehydration	1,599	2.5%	193	1,020
Rash	1,568	2.5%	126	306
Anaemia	1,567	2.5%	267	430
Stomatitis	1,558	2.5%	172	429
Dyspnoea	1,507	2.4%	272	674

Who Reports CAPECITABINE Side Effects? Age & Gender Data

Gender: 65.1% female, 34.9% male. Average age: 61.8 years. Most reports from: US. View detailed demographics →

Is CAPECITABINE Getting Safer? Reports by Year

Year	Reports	Deaths	Hosp.
2000	3	1	2
2001	5	4	2