Capecitabine side effects: what 90,995 FDA adverse event reports show
Drug class
Nucleoside Metabolic Inhibitor
Who reports
90,995 reports · 82% serious · 18,292 with death outcome · 64% female
Used for
Capecitabine tablet is a nucleoside metabolic inhibitor indicated for: Colorectal Cancer • adjuvant treatment of patients with Stage III colon cancer as a single agent or as a component of a combination chemotherapy regimen. ( 1.1 ) • perioperative treatment of adults with locally advanced rectal cancer as a component of chemoradiotherapy.
What it is
Capecitabine, USP is a nucleoside metabolic inhibitor.
Boxed warning
SERIOUS ADVERSE REACTIONS OR DEATH IN PATIENTS WITH COMPLETE DPD DEFICIENCY and BLEEDING WITH CONCOMITANT USE OF VITAMIN K ANTAGONISTS Increased risk of serious adverse reactions or death in patients with complete DPD deficiency Test patients for genetic variants of DPYD prior to initiating capecitabine tablets unless immediate treatment is necessary.
Causality screen of the 40 strongest signals
What the badges mean
- Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
- Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
- Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
- Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
- Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.
Strongest disproportionality signals
Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only (and, for the 300 most-reported drugs, adjusted for age band), and flags pairs whose reports are unusually skewed by sex or come mostly from consumers. Each row also shows the PRR against the other drugs of the same FDA class, which removes most confounding by the condition being treated, and a calibrated p-value: on validation, known non-causes average an ROR of about 2, so significance is judged against that empirical null (✓ = p < 0.05 after calibration). 1,211 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Dihydropyrimidine dehydrogenase deficiency | 153 | 587.1 434.8–792.8ROR 588.1 · calibrated p 4e-14 ✓ | 160.9 EB05 140.6 · IC025 +6.5 3/3 methods agree vs other Nucleoside Metabolic Inhibitors: PRR 22.2 (15.8–31.2) | Labeled (related wording) related wording | serious n=149 | not reported in cached trials |
| Fingerprint loss | 74 | 194.8 142.8–265.8ROR 195.0 · calibrated p 1e-9 ✓ | 102.5 EB05 84.3 · IC025 +5.6 3/3 methods agree vs other Nucleoside Metabolic Inhibitors: only this drug | Labeled (related wording) related wording | serious n=39 | not reported in cached trials |
| Pik3ca-activated mutation | 107 | 112.7 89.4–142.1ROR 112.8 · calibrated p 7e-8 ✓ | 74.6 EB05 63.5 · IC025 +5.5 3/3 methods agree vs other Nucleoside Metabolic Inhibitors: only this drug | Not in label — unassessed | serious n=107 · ♀ 100% (drug 64%) · 100% clinician | not reported in cached trials |
| Dysaesthesia pharynx | 56 | 108.4 78.8–149.0ROR 108.4 · calibrated p 1e-7 ✓ | 71.9 EB05 57.4 · IC025 +5.0 3/3 methods agree vs other Nucleoside Metabolic Inhibitors: only this drug | Not in label — unassessed | serious n=55 · ♀ 100% (drug 64%) · 100% clinician | not reported in cached trials |
| Palmar-plantar erythrodysaesthesia syndrome | 6,675 | 92.1 89.6–94.7ROR 99.3 · calibrated p 1e-7 ✓ | 65.8 EB05 64.4 · IC025 +6.0 3/3 methods agree vs other Nucleoside Metabolic Inhibitors: PRR 32.6 (30.7–34.6) | Not in label — unassessed | age-adj. PRR 66.1 · serious PRR 47.3 | NCT00089479: 1/1,305 (0.1%) on Capecitabine (serious AE) |
| Tumour perforation | 76 | 74.5 57.5–96.5ROR 74.6 · calibrated p 1e-6 ✓ | 55.6 EB05 45.8 · IC025 +5.0 3/3 methods agree vs other Nucleoside Metabolic Inhibitors: PRR 8.4 (6.0–11.9) | Not in label — unassessed | serious n=76 · ♀ 0% (drug 64%) · 100% clinician | not reported in cached trials |
| Pseudocirrhosis | 73 | 65.9 50.7–85.5ROR 65.9 · calibrated p 3e-6 ✓ | 50.6 EB05 41.6 · IC025 +4.9 3/3 methods agree vs other Nucleoside Metabolic Inhibitors: only this drug | Not in label — unassessed | serious n=73 · ♀ 100% (drug 64%) · 100% clinician | not reported in cached trials |
| Pancreatic neuroendocrine tumour metastatic | 51 | 62.4 45.8–85.1ROR 62.5 · calibrated p 5e-6 ✓ | 48.3 EB05 38.2 · IC025 +4.6 3/3 methods agree vs other Nucleoside Metabolic Inhibitors: only this drug | Labeled (related wording) related wording | serious n=51 · ♀ 0% (drug 64%) | not reported in cached trials |
| Metastases to eye | 46 | 60.6 43.7–83.8ROR 60.6 · calibrated p 7e-6 ✓ | 47.1 EB05 36.8 · IC025 +4.5 3/3 methods agree vs other Nucleoside Metabolic Inhibitors: only this drug | Labeled (related wording) related wording | serious n=46 · ♀ 100% (drug 64%) | NCT00089479: 1/1,305 (0.1%) on Capecitabine (serious AE) |
| Skin chapped | 81 | 56.8 44.5–72.4ROR 56.8 · calibrated p 8e-6 ✓ | 45.1 EB05 37.5 · IC025 +4.8 3/3 methods agree vs other Nucleoside Metabolic Inhibitors: only this drug | Not in label — unassessed | serious n=51 · ♀ 100% (drug 64%) · 100% consumer | not reported in cached trials |
| Anastomotic leak | 135 | 55.4 45.9–66.8ROR 55.5 · calibrated p 8e-6 ✓ | 44.4 EB05 38.5 · IC025 +5.0 3/3 methods agree vs other Nucleoside Metabolic Inhibitors: PRR 9.8 (7.5–12.9) | Not in label — unassessed | serious n=134 · ♀ 0% (drug 64%) · 100% clinician | not reported in cached trials |
| Metastases to skin | 175 | 47.4 40.3–55.8ROR 47.5 · calibrated p 2e-5 ✓ | 39.2 EB05 34.6 · IC025 +4.9 3/3 methods agree vs other Nucleoside Metabolic Inhibitors: PRR 20.1 (14.8–27.3) | Labeled (related wording) related wording | serious n=174 · ♀ 100% (drug 64%) | not reported in cached trials |
| Anastomotic complication | 59 | 46.5 35.2–61.6ROR 46.6 · calibrated p 3e-5 ✓ | 38.3 EB05 30.8 · IC025 +4.4 3/3 methods agree vs other Nucleoside Metabolic Inhibitors: PRR 8.4 (5.6–12.4) | Reporting / coding artifact | serious n=59 · ♀ 0% (drug 64%) · 100% clinician | not reported in cached trials |
| Nail bed inflammation | 53 | 46.0 34.2–61.8ROR 46.0 · calibrated p 3e-5 ✓ | 37.9 EB05 30.1 · IC025 +4.4 3/3 methods agree vs other Nucleoside Metabolic Inhibitors: only this drug | Not in label — unassessed | serious n=51 · ♀ 100% (drug 64%) | not reported in cached trials |
| Metastases to the mediastinum | 65 | 42.7 32.7–55.6ROR 42.7 · calibrated p 5e-5 ✓ | 35.7 EB05 29.0 · IC025 +4.4 3/3 methods agree vs other Nucleoside Metabolic Inhibitors: only this drug | Not in label — unassessed | serious n=65 · ♀ 100% (drug 64%) | not reported in cached trials |
| Arteriospasm coronary | 585 | 40.0 36.7–43.7ROR 40.3 · calibrated p 5e-5 ✓ | 34.1 EB05 31.9 · IC025 +4.9 3/3 methods agree vs other Nucleoside Metabolic Inhibitors: PRR 6.5 (5.8–7.3) | Not in label — unassessed | serious n=582 · 95% clinician | not reported in cached trials |
| Her2 positive breast cancer | 53 | 38.6 28.8–51.6ROR 38.6 · calibrated p 9e-5 ✓ | 32.8 EB05 26.0 · IC025 +4.2 3/3 methods agree vs other Nucleoside Metabolic Inhibitors: only this drug | Not in label — unassessed | serious n=53 · ♀ 100% (drug 64%) · 100% clinician | not reported in cached trials |
| Mucosal toxicity | 39 | 38.4 27.3–53.9ROR 38.4 · calibrated p 1e-4 ✓ | 32.5 EB05 24.8 · IC025 +4.0 3/3 methods agree vs other Nucleoside Metabolic Inhibitors: PRR 4.3 (2.9–6.5) | Not in label — unassessed | serious n=39 · 100% clinician | not reported in cached trials |
| Non-cirrhotic portal hypertension | 52 | 38.4 28.6–51.5ROR 38.4 · calibrated p 9e-5 ✓ | 32.6 EB05 25.8 · IC025 +4.2 3/3 methods agree vs other Nucleoside Metabolic Inhibitors: PRR 4.1 (2.9–5.8) | Not in label — unassessed | serious n=52 · 100% clinician | not reported in cached trials |
| Gastrointestinal anastomotic leak | 53 | 35.8 26.8–47.9ROR 35.8 · calibrated p 1e-4 ✓ | 30.8 EB05 24.4 · IC025 +4.1 3/3 methods agree vs other Nucleoside Metabolic Inhibitors: PRR 6.2 (4.2–9.1) | Not in label — unassessed | serious n=52 · ♀ 0% (drug 64%) · 100% clinician | not reported in cached trials |
| Metastases to chest wall | 46 | 35.2 25.8–48.0ROR 35.2 · calibrated p 2e-4 ✓ | 30.2 EB05 23.6 · IC025 +4.0 3/3 methods agree vs other Nucleoside Metabolic Inhibitors: only this drug | Not in label — unassessed | serious n=45 · ♀ 100% (drug 64%) · 100% clinician | not reported in cached trials |
| Carbohydrate antigen 15-3 increased | 100 | 34.7 28.1–42.9ROR 34.8 · calibrated p 1e-4 ✓ | 30.1 EB05 25.5 · IC025 +4.4 3/3 methods agree vs other Nucleoside Metabolic Inhibitors: only this drug | Lab value / disease marker | serious n=96 · ♀ 100% (drug 64%) | not reported in cached trials |
| Metastases to pleura | 135 | 34.2 28.6–41.0ROR 34.3 · calibrated p 1e-4 ✓ | 29.8 EB05 25.8 · IC025 +4.5 3/3 methods agree vs other Nucleoside Metabolic Inhibitors: PRR 17.5 (12.6–24.4) | Labeled (related wording) related wording | serious n=135 · ♀ 100% (drug 64%) | not reported in cached trials |
| Gastroenteritis radiation | 39 | 30.8 22.0–43.0ROR 30.8 · calibrated p 3e-4 ✓ | 26.9 EB05 20.5 · IC025 +3.8 3/3 methods agree vs other Nucleoside Metabolic Inhibitors: only this drug | Labeled (related wording) related wording | serious n=39 · 100% clinician | not reported in cached trials |
| Breast cancer metastatic | 1,230 | 29.8 28.1–31.6ROR 30.2 · calibrated p 3e-4 ✓ | 26.4 EB05 25.2 · IC025 +4.6 3/3 methods agree vs other Nucleoside Metabolic Inhibitors: PRR 37.5 (32.3–43.5) | Likely indication confounding term in indications; also in warnings | serious PRR 18.6 · ♀ 100% (drug 64%) | not reported in cached trials |
| Gastrointestinal toxicity | 516 | 28.3 25.8–31.0ROR 28.4 · calibrated p 4e-4 ✓ | 25.2 EB05 23.5 · IC025 +4.5 3/3 methods agree vs other Nucleoside Metabolic Inhibitors: PRR 4.8 (4.3–5.4) | Labeled (related wording) related wording | serious n=513 · 96% clinician | not reported in cached trials |
| Metastases to liver | 1,842 | 27.0 25.7–28.3ROR 27.5 · calibrated p 4e-4 ✓ | 24.2 EB05 23.3 · IC025 +4.5 3/3 methods agree vs other Nucleoside Metabolic Inhibitors: PRR 11.4 (10.5–12.3) | Labeled (related wording) related wording | serious PRR 16.9 | not reported in cached trials |
| Carcinoembryonic antigen increased | 199 | 26.4 22.8–30.6ROR 26.5 · calibrated p 5e-4 ✓ | 23.7 EB05 21.1 · IC025 +4.3 3/3 methods agree vs other Nucleoside Metabolic Inhibitors: PRR 10.4 (8.2–13.0) | Lab value / disease marker | serious n=183 | not reported in cached trials |
| Terminal ileitis | 61 | 25.9 19.8–33.7ROR 25.9 · calibrated p 7e-4 ✓ | 23.2 EB05 18.7 · IC025 +3.9 3/3 methods agree vs other Nucleoside Metabolic Inhibitors: only this drug | Not in label — unassessed | serious n=61 · ♀ 0% (drug 64%) · 100% clinician | not reported in cached trials |
| Metastases to peritoneum | 247 | 25.1 22.0–28.7ROR 25.2 · calibrated p 7e-4 ✓ | 22.7 EB05 20.4 · IC025 +4.2 3/3 methods agree vs other Nucleoside Metabolic Inhibitors: PRR 8.7 (7.2–10.6) | Not in label — unassessed | serious n=247 | not reported in cached trials |
| Radiation skin injury | 112 | 24.5 20.2–29.8ROR 24.6 · calibrated p 8e-4 ✓ | 22.2 EB05 18.9 · IC025 +4.0 3/3 methods agree vs other Nucleoside Metabolic Inhibitors: PRR 7.8 (5.9–10.4) | Not in label — unassessed | serious n=109 · ♀ 100% (drug 64%) | not reported in cached trials |
| Metastases to lung | 1,024 | 22.4 21.0–23.8ROR 22.6 · calibrated p 0.001 ✓ | 20.4 EB05 19.4 · IC025 +4.2 3/3 methods agree vs other Nucleoside Metabolic Inhibitors: PRR 10.5 (9.5–11.6) | Not in label — unassessed | serious PRR 14.3 | not reported in cached trials |
| Colon cancer metastatic | 140 | 21.9 18.4–26.1ROR 22.0 · calibrated p 0.001 ✓ | 20.0 EB05 17.4 · IC025 +4.0 3/3 methods agree vs other Nucleoside Metabolic Inhibitors: PRR 6.7 (5.3–8.5) | Likely indication confounding term in indications; also in warnings | serious n=137 · ♀ 35% (drug 64%) | not reported in cached trials |
| Rectal perforation | 45 | 20.9 15.4–28.3ROR 20.9 · calibrated p 0.002 ✓ | 19.1 EB05 14.8 · IC025 +3.5 3/3 methods agree vs other Nucleoside Metabolic Inhibitors: PRR 5.0 (3.4–7.4) | Not in label — unassessed | serious n=45 · ♀ 0% (drug 64%) · 100% clinician | not reported in cached trials |
| Metastases to central nervous system | 1,067 | 20.9 19.6–22.2ROR 21.1 · calibrated p 0.002 ✓ | 19.2 EB05 18.2 · IC025 +4.1 3/3 methods agree vs other Nucleoside Metabolic Inhibitors: PRR 28.0 (24.3–32.3) | Labeled (related wording) related wording | serious PRR 13.3 · ♀ 90% (drug 64%) | not reported in cached trials |
| Metastases to lymph nodes | 549 | 20.5 18.8–22.3ROR 20.6 · calibrated p 0.002 ✓ | 18.9 EB05 17.6 · IC025 +4.1 3/3 methods agree vs other Nucleoside Metabolic Inhibitors: PRR 13.5 (11.7–15.7) | Not in label — unassessed | serious n=546 | not reported in cached trials |
| Ejection fraction | 47 | 20.1 14.9–27.1ROR 20.1 · calibrated p 0.002 ✓ | 18.4 EB05 14.4 · IC025 +3.5 3/3 methods agree vs other Nucleoside Metabolic Inhibitors: only this drug | Not in label — unassessed | serious n=46 · ♀ 100% (drug 64%) | not reported in cached trials |
| Metastases to bone | 1,311 | 20.0 18.9–21.2ROR 20.3 · calibrated p 0.002 ✓ | 18.5 EB05 17.6 · IC025 +4.1 3/3 methods agree vs other Nucleoside Metabolic Inhibitors: PRR 24.3 (21.6–27.5) | Labeled (related wording) related wording | serious PRR 12.9 · ♀ 94% (drug 64%) | not reported in cached trials |
| Nasal mucosal disorder | 46 | 19.6 14.5–26.5ROR 19.6 · calibrated p 0.003 ✓ | 18.0 EB05 14.0 · IC025 +3.4 3/3 methods agree vs other Nucleoside Metabolic Inhibitors: only this drug | Not in label — unassessed | serious n=45 · ♀ 100% (drug 64%) · 100% clinician | not reported in cached trials |
| Mucosal inflammation | 1,992 | 19.0 18.2–19.9ROR 19.4 · calibrated p 0.002 ✓ | 17.6 EB05 17.0 · IC025 +4.1 3/3 methods agree vs other Nucleoside Metabolic Inhibitors: PRR 3.0 (2.9–3.2) | Labeled (related wording) related wording | age-adj. PRR 16.1 · serious PRR 12.7 · 91% clinician | not reported in cached trials |
Clinical concept groups
MedDRA splits one clinical problem across several terms (e.g. "neutropenia", "neutrophil count decreased", "agranulocytosis"), which dilutes term-level signals. These rows count reports with any term in a concept group (an exact union, not a sum), compared with all other drugs. Groups are hand-built and listed in the methods.
| Concept | Reports | PRR 95% CI | Reading |
|---|---|---|---|
| Neutropenia / agranulocytosis | 4,626 | 4.44.2–4.5 | signal |
| Thrombocytopenia | 3,805 | 4.03.9–4.2 | signal |
| Osteonecrosis | 825 | 3.33.1–3.6 | signal |
| Anaemia | 3,104 | 2.42.3–2.5 | signal |
| Venous thromboembolism | 2,216 | 2.42.3–2.5 | signal |
| Interstitial lung disease | 957 | 2.32.2–2.5 | signal |
| Liver injury | 2,826 | 2.22.1–2.3 | signal |
| Hyponatraemia | 650 | 1.91.7–2.0 | raised |
| Gi bleeding | 1,164 | 1.51.4–1.6 | raised |
| Serious infection | 4,504 | 1.31.3–1.4 | raised |
| Kidney injury | 2,640 | 1.31.3–1.4 | raised |
| Heart failure | 965 | 1.21.2–1.3 | raised |
| Malignancy | 1,670 | 1.01.0–1.1 | no difference |
| Arrhythmia / qt | 857 | 1.01.0–1.1 | no difference |
| Pancreatitis | 344 | 1.00.9–1.1 | no difference |
| Stroke | 936 | 0.90.8–0.9 | lower than other drugs |
Trial evidence (ClinicalTrials.gov)
✓ Trial adverse-event data found on ClinicalTrials.gov
Largest completed trials with posted results that list Capecitabine as a study intervention. The right-hand column of the signal table shows whether each FAERS term was also recorded in these trials, with a real denominator (2 of 40 signal terms matched).
- NCT00089479 — A Study of Xeloda (Capecitabine) in Women With High-Risk Breast Cancer (N=2611, PHASE3; 246 AE terms posted; arms: AC Then T; AC Then XT)
Caveats: trial populations, doses and follow-up differ from the reporting population; AE terms are sponsor-coded and matched here by wording; absence from a trial list means the term was not reported above the sponsor's frequency threshold, not that it cannot occur.
Most frequently reported reactions
By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Diarrhoea (diarrhea) | 13,623 | 5.0 4.9–5.0ROR 5.7 · calibrated p 0.174 | 4.9 EB05 4.8 · IC025 +2.3 3/3 methods agree vs other Nucleoside Metabolic Inhibitors: PRR 8.2 (8.1–8.4) | Labeled — boxed warning exact term | age-adj. PRR 4.1 · serious PRR 4.7 | NCT00089479: 10/1,305 (0.8%) on Capecitabine (serious AE) |
| Death | 8,844 | 2.4 2.3–2.4ROR 2.5 · calibrated p 0.801 | 2.4 EB05 2.3 · IC025 +1.2 3/3 methods agree vs other Nucleoside Metabolic Inhibitors: PRR 5.6 (5.5–5.8) | Outcome field, not a reaction boxed warning mentions mortality | age-adj. PRR 1.8 · serious PRR 1.6 | not reported in cached trials |
| Nausea | 8,456 | 2.5 2.4–2.5ROR 2.6 · calibrated p 0.756 | 2.5 EB05 2.4 · IC025 +1.3 3/3 methods agree vs other Nucleoside Metabolic Inhibitors: PRR 6.2 (6.0–6.3) | Labeled adverse reaction exact term | age-adj. PRR 2.1 · serious PRR 2.5 | NCT00089479: 7/1,305 (0.5%) on Capecitabine (serious AE) |
| Palmar-plantar erythrodysaesthesia syndrome | 6,675 | 92.1 89.6–94.7ROR 99.3 · calibrated p 1e-7 ✓ | 65.8 EB05 64.4 · IC025 +6.0 3/3 methods agree vs other Nucleoside Metabolic Inhibitors: PRR 32.6 (30.7–34.6) | Not in label — unassessed | age-adj. PRR 66.1 · serious PRR 47.3 | NCT00089479: 1/1,305 (0.1%) on Capecitabine (serious AE) |
| Fatigue (tiredness) | 6,476 | 1.9 1.9–2.0ROR 2.0 · calibrated p 0.944 | 1.9 EB05 1.9 · IC025 +0.9 vs other Nucleoside Metabolic Inhibitors: PRR 7.7 (7.5–8.0) | Labeled adverse reaction exact term | age-adj. PRR 1.6 · serious PRR 1.8 | NCT00089479: 2/1,305 (0.2%) on Capecitabine (serious AE) |
| Vomiting | 6,281 | 3.1 3.0–3.2ROR 3.3 · calibrated p 0.544 | 3.1 EB05 3.0 · IC025 +1.6 3/3 methods agree vs other Nucleoside Metabolic Inhibitors: PRR 5.7 (5.6–5.9) | Labeled adverse reaction exact term | age-adj. PRR 2.6 · serious PRR 2.8 | NCT00089479: 13/1,305 (1.0%) on Capecitabine (serious AE) |
| Disease progression | 6,057 | 12.4 12.1–12.7ROR 13.2 · calibrated p 0.011 ✓ | 11.8 EB05 11.6 · IC025 +3.5 3/3 methods agree vs other Nucleoside Metabolic Inhibitors: PRR 5.0 (4.8–5.1) | Reporting / coding artifact | age-adj. PRR 11.0 · serious PRR 8.3 | not reported in cached trials |
| Malignant neoplasm progression | 3,968 | 9.3 9.0–9.6ROR 9.7 · calibrated p 0.036 ✓ | 9.0 EB05 8.7 · IC025 +3.1 3/3 methods agree vs other Nucleoside Metabolic Inhibitors: PRR 6.6 (6.3–6.8) | Reporting / coding artifact | age-adj. PRR 7.3 · serious PRR 6.3 | not reported in cached trials |
| Off label use (used outside approved label) | 3,829 | 1.0 1.0–1.0ROR 1.0 · calibrated p 0.318 | 1.0 EB05 1.0 · IC025 -0.0 PRR-only: not supported by EBGM or IC vs other Nucleoside Metabolic Inhibitors: PRR 1.8 (1.8–1.9) | Reporting / coding artifact | age-adj. PRR 1.0 · serious PRR 1.0 | not reported in cached trials |
| Asthenia (weakness) | 3,414 | 2.1 2.0–2.2ROR 2.1 · calibrated p 0.979 | 2.1 EB05 2.0 · IC025 +1.0 3/3 methods agree vs other Nucleoside Metabolic Inhibitors: PRR 4.8 (4.6–5.0) | Labeled adverse reaction exact term | age-adj. PRR 1.8 · serious PRR 1.9 | NCT00089479: 2/1,305 (0.2%) on Capecitabine (serious AE) |
| Decreased appetite (loss of appetite) | 3,269 | 3.3 3.2–3.4ROR 3.4 · calibrated p 0.518 | 3.3 EB05 3.2 · IC025 +1.6 3/3 methods agree vs other Nucleoside Metabolic Inhibitors: PRR 6.3 (6.0–6.6) | Labeled adverse reaction exact term | age-adj. PRR 2.6 · serious PRR 2.9 | NCT00089479: 440/1,305 (33.7%) on Capecitabine |
| Neutropenia (low neutrophils (infection-fighting cells)) | 3,111 | 5.4 5.2–5.6ROR 5.5 · calibrated p 0.183 | 5.3 EB05 5.1 · IC025 +2.3 3/3 methods agree vs other Nucleoside Metabolic Inhibitors: PRR 1.5 (1.4–1.5) | Labeled adverse reaction exact term | age-adj. PRR 3.8 · serious PRR 3.8 · 92% clinician | NCT00089479: 118/1,305 (9.0%) on Capecitabine (serious AE) |
| Neuropathy peripheral (nerve damage in hands/feet) | 2,897 | 7.3 7.0–7.5ROR 7.5 · calibrated p 0.082 | 7.1 EB05 6.8 · IC025 +2.8 3/3 methods agree vs other Nucleoside Metabolic Inhibitors: PRR 4.1 (3.9–4.3) | Labeled (related wording) related wording | age-adj. PRR 6.7 · serious PRR 4.8 | NCT00089479: 327/1,305 (25.1%) on Capecitabine |
| Dehydration | 2,753 | 4.8 4.7–5.0ROR 5.0 · calibrated p 0.239 | 4.8 EB05 4.6 · IC025 +2.2 3/3 methods agree vs other Nucleoside Metabolic Inhibitors: PRR 7.5 (7.1–7.9) | Labeled — boxed warning exact term | age-adj. PRR 3.7 · serious PRR 3.5 | NCT00089479: 11/1,305 (0.8%) on Capecitabine (serious AE) |
| Dyspnoea (shortness of breath) | 2,670 | 1.1 1.0–1.1ROR 1.1 · calibrated p 0.367 | 1.1 EB05 1.1 · IC025 +0.1 vs other Nucleoside Metabolic Inhibitors: PRR 4.4 (4.2–4.6) | Labeled adverse reaction exact term | age-adj. PRR 1.0 · serious PRR 1.0 | NCT00089479: 5/1,305 (0.4%) on Capecitabine (serious AE) |
Unlabeled candidate signals
These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.
- Pik3ca-activated mutation — n=107, PRR 112.7
- Dysaesthesia pharynx — n=56, PRR 108.4
- Palmar-plantar erythrodysaesthesia syndrome — n=6,675, PRR 92.1 (also seen in trial arm)
- Tumour perforation — n=76, PRR 74.5
- Pseudocirrhosis — n=73, PRR 65.9
- Skin chapped — n=81, PRR 56.8
- Anastomotic leak — n=135, PRR 55.4
- Nail bed inflammation — n=53, PRR 46.0
- Metastases to the mediastinum — n=65, PRR 42.7
- Arteriospasm coronary — n=585, PRR 40.0
✓ A hand-written Bradford Hill causality assessment exists for this drug: Capecitabine ↔ Palmar-plantar erythrodysaesthesia (hand-foot syndrome).
Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.
Common questions
What are the most reported side effects of Capecitabine?
In FDA FAERS, the most frequently co-reported reaction terms for Capecitabine are diarrhoea, nausea, palmar-plantar erythrodysaesthesia syndrome, fatigue, vomiting, asthenia. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.
Does Capecitabine have an FDA boxed warning?
Yes. The current FDA label carries a boxed warning: SERIOUS ADVERSE REACTIONS OR DEATH IN PATIENTS WITH COMPLETE DPD DEFICIENCY and BLEEDING WITH CONCOMITANT USE OF VITAMIN K ANTAGONISTS Increased risk of serious adverse reactions or death in patients with complete DPD deficiency Test patients for genetic variants of DPYD prior to initiating capecitabine tablets unless immediate treatment is necessary.
Do FAERS signals prove that Capecitabine causes these side effects?
No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.
Sources & methods
- FDA label via openFDA (set ID 007e3432-c8aa-2a76-52ba-c346924c08a7, effective 20251120; matched on
openfda.generic_name.exact:"CAPECITABINE") - Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
- FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA
count=aggregation, fieldpatient.drug.openfda.generic_name.exact, 1,251 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction - Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
- Seriousness and sex counts from openFDA
count=serious,patient.patientsex,seriousnessdeath - ClinicalTrials.gov API v2 (query
CAPECITABINE, results-bearing studies sorted by enrollment)
Page generated 2026-10-14. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.