Gemcitabine side effects: what 39,157 FDA adverse event reports show
Drug class
Nucleoside metabolic inhibitor
Who reports
39,157 reports · 97% serious · 7,396 with death outcome · 49% female
Used for
Gemcitabine is a nucleoside metabolic inhibitor indicated: • in combination with carboplatin, for the treatment of advanced ovarian cancer that has relapsed at least 6 months after completion of platinum-based therapy. ( 1.1 ) • in combination with pac.
What it is
Gemcitabine is a nucleoside metabolic inhibitor. Gemcitabine hydrochloride is 2´-deoxy-2´,2´-difluorocytidine monohydrochloride (β-isomer) with the following structural formula:
Boxed warning
None in the current label
Causality screen of the 40 strongest signals
What the badges mean
- Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
- 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.
- 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). 1,117 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 |
|---|---|---|---|---|---|---|
| Non-renal cell carcinoma of kidney | 15 | 988.8 419.2–2,332.1ROR 989.2 · calibrated p 4e-13 ✓ | 239.6 EB05 154.2 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious n=15 | not reported in cached trials |
| Desmoplastic small round cell tumour | 36 | 372.3 243.0–570.3ROR 372.6 · calibrated p 9e-12 ✓ | 196.0 EB05 147.9 · IC025 +5.2 3/3 methods agree | Not in label — unassessed | serious n=36 · ♀ 78% (drug 49%) · 100% clinician | not reported in cached trials |
| Refractory cancer | 51 | 165.0 120.5–225.9ROR 165.2 · calibrated p 5e-9 ✓ | 120.3 EB05 95.1 · IC025 +5.4 3/3 methods agree | Not in label — unassessed | serious n=51 | not reported in cached trials |
| Pseudocellulitis | 49 | 161.5 117.3–222.4ROR 161.7 · calibrated p 6e-9 ✓ | 118.3 EB05 93.0 · IC025 +5.3 3/3 methods agree | Labeled adverse reaction exact term | serious n=45 · 100% clinician | not reported in cached trials |
| Pseudocirrhosis | 68 | 140.1 107.2–183.0ROR 140.3 · calibrated p 1e-8 ✓ | 107.6 EB05 87.8 · IC025 +5.5 3/3 methods agree | Not in label — unassessed | serious n=68 · ♀ 100% (drug 49%) · 100% clinician | not reported in cached trials |
| Platelet toxicity | 19 | 139.2 84.0–230.7ROR 139.2 · calibrated p 6e-8 ✓ | 99.6 EB05 67.4 · IC025 +4.1 3/3 methods agree | Labeled (related wording) related wording | serious n=19 | not reported in cached trials |
| Diffuse large b-cell lymphoma recurrent | 313 | 91.3 81.1–103.0ROR 92.1 · calibrated p 2e-7 ✓ | 77.7 EB05 70.7 · IC025 +5.9 3/3 methods agree | Not in label — unassessed | serious n=311 · 97% clinician | not reported in cached trials |
| Ductal adenocarcinoma of pancreas | 38 | 85.6 60.8–120.6ROR 85.7 · calibrated p 7e-7 ✓ | 71.3 EB05 54.2 · IC025 +4.7 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=38 · 100% clinician | not reported in cached trials |
| Biliary tract infection | 81 | 81.8 64.8–103.4ROR 82.0 · calibrated p 7e-7 ✓ | 69.9 EB05 58.0 · IC025 +5.3 3/3 methods agree | Labeled (related wording) related wording | serious n=80 | not reported in cached trials |
| Diffuse large b-cell lymphoma refractory | 119 | 78.5 64.8–95.2ROR 78.8 · calibrated p 8e-7 ✓ | 67.8 EB05 58.2 · IC025 +5.4 3/3 methods agree | Not in label — unassessed | serious n=118 | not reported in cached trials |
| Recall phenomenon | 101 | 73.6 59.8–90.6ROR 73.8 · calibrated p 1e-6 ✓ | 63.9 EB05 54.1 · IC025 +5.3 3/3 methods agree | Not in label — unassessed | serious n=98 · ♀ 75% (drug 49%) · 100% clinician | not reported in cached trials |
| Cholangitis infective | 28 | 63.9 43.2–94.6ROR 64.0 · calibrated p 6e-6 ✓ | 55.1 EB05 40.0 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious n=28 · 100% clinician | not reported in cached trials |
| Pancreatic carcinoma recurrent | 24 | 60.3 39.5–91.9ROR 60.3 · calibrated p 1e-5 ✓ | 52.1 EB05 36.8 · IC025 +4.0 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=24 · 91% clinician | not reported in cached trials |
| Biliary sepsis | 44 | 56.3 41.3–76.8ROR 56.4 · calibrated p 1e-5 ✓ | 49.9 EB05 38.7 · IC025 +4.5 3/3 methods agree | Labeled (related wording) related wording | serious n=44 · 91% clinician | not reported in cached trials |
| Pancreatic carcinoma metastatic | 269 | 55.6 49.1–63.0ROR 56.0 · calibrated p 7e-6 ✓ | 50.2 EB05 45.4 · IC025 +5.3 3/3 methods agree | Likely indication confounding term in indications | serious n=268 · 95% clinician | not reported in cached trials |
| Metastases to retroperitoneum | 16 | 55.5 33.2–92.9ROR 55.5 · calibrated p 2e-5 ✓ | 47.7 EB05 31.1 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious n=16 | not reported in cached trials |
| Metastases to muscle | 16 | 52.4 31.4–87.6ROR 52.4 · calibrated p 3e-5 ✓ | 45.4 EB05 29.6 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious n=16 | not reported in cached trials |
| Pik3ca-activated mutation | 29 | 52.2 35.6–76.4ROR 52.2 · calibrated p 2e-5 ✓ | 46.2 EB05 33.8 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious n=29 · ♀ 73% (drug 49%) · 100% clinician | not reported in cached trials |
| Renal-limited thrombotic microangiopathy | 20 | 52.0 32.8–82.2ROR 52.0 · calibrated p 3e-5 ✓ | 45.5 EB05 31.1 · IC025 +3.7 3/3 methods agree | Labeled (related wording) related wording | serious n=20 | not reported in cached trials |
| High-grade b-cell lymphoma | 16 | 49.6 29.7–82.9ROR 49.7 · calibrated p 4e-5 ✓ | 43.3 EB05 28.2 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious n=16 | not reported in cached trials |
| Pancreatic abscess | 16 | 46.6 28.0–77.7ROR 46.6 · calibrated p 6e-5 ✓ | 41.0 EB05 26.7 · IC025 +3.4 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=16 | not reported in cached trials |
| Toxic erythema of chemotherapy | 19 | 46.4 29.0–74.1ROR 46.4 · calibrated p 5e-5 ✓ | 41.1 EB05 27.8 · IC025 +3.6 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=18 | not reported in cached trials |
| Haemolytic uraemic syndrome | 185 | 45.8 39.4–53.2ROR 46.0 · calibrated p 2e-5 ✓ | 42.1 EB05 37.2 · IC025 +5.0 3/3 methods agree | Labeled adverse reaction exact term | serious n=185 · 98% clinician | not reported in cached trials |
| Thrombotic microangiopathy | 681 | 40.4 37.4–43.7ROR 41.1 · calibrated p 4e-5 ✓ | 37.6 EB05 35.3 · IC025 +5.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 22.3 · 98% clinician | not reported in cached trials |
| Adenocarcinoma pancreas | 89 | 39.7 32.0–49.2ROR 39.8 · calibrated p 6e-5 ✓ | 36.7 EB05 30.8 · IC025 +4.6 3/3 methods agree | Likely indication confounding term in indications | serious n=89 · 98% clinician | not reported in cached trials |
| Adenoviral hepatitis | 15 | 37.0 21.9–62.4ROR 37.0 · calibrated p 2e-4 ✓ | 33.3 EB05 21.4 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=15 | not reported in cached trials |
| Metastases to bone marrow | 32 | 36.3 25.4–51.9ROR 36.3 · calibrated p 1e-4 ✓ | 33.4 EB05 24.8 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious n=32 | not reported in cached trials |
| Hypercalcaemia of malignancy | 17 | 35.7 21.9–58.4ROR 35.7 · calibrated p 2e-4 ✓ | 32.4 EB05 21.4 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious n=17 | not reported in cached trials |
| Metastases to spleen | 25 | 34.2 22.8–51.2ROR 34.2 · calibrated p 2e-4 ✓ | 31.4 EB05 22.4 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious n=25 | not reported in cached trials |
| Follicular lymphoma | 51 | 34.0 25.6–45.1ROR 34.0 · calibrated p 2e-4 ✓ | 31.7 EB05 25.0 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious n=51 · 94% clinician | not reported in cached trials |
| Cholangitis | 368 | 34.0 30.6–37.7ROR 34.3 · calibrated p 1e-4 ✓ | 31.9 EB05 29.3 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious n=368 · 95% clinician | not reported in cached trials |
| Metastases to chest wall | 20 | 32.8 20.9–51.5ROR 32.8 · calibrated p 3e-4 ✓ | 30.1 EB05 20.6 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious n=20 | not reported in cached trials |
| Metastases to peritoneum | 144 | 32.6 27.6–38.6ROR 32.7 · calibrated p 2e-4 ✓ | 30.7 EB05 26.7 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious n=144 · ♀ 69% (drug 49%) · 93% clinician | not reported in cached trials |
| Capillary leak syndrome | 117 | 32.3 26.8–38.9ROR 32.4 · calibrated p 2e-4 ✓ | 30.4 EB05 26.0 · IC025 +4.5 3/3 methods agree | Labeled adverse reaction exact term | serious n=117 · 100% clinician | not reported in cached trials |
| Duodenal obstruction | 17 | 32.2 19.8–52.6ROR 32.3 · calibrated p 4e-4 ✓ | 29.5 EB05 19.5 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=17 | not reported in cached trials |
| Egfr gene mutation | 20 | 29.9 19.0–46.9ROR 29.9 · calibrated p 5e-4 ✓ | 27.7 EB05 18.9 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious n=20 | not reported in cached trials |
| Haematotoxicity | 490 | 29.8 27.3–32.7ROR 30.2 · calibrated p 3e-4 ✓ | 28.3 EB05 26.2 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious PRR 17.2 · 98% clinician | not reported in cached trials |
| Atypical haemolytic uraemic syndrome | 41 | 28.6 20.9–39.2ROR 28.7 · calibrated p 5e-4 ✓ | 26.9 EB05 20.7 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious n=41 · 100% clinician | not reported in cached trials |
| Duodenal stenosis | 23 | 26.8 17.7–40.8ROR 26.8 · calibrated p 8e-4 ✓ | 25.1 EB05 17.6 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious n=22 | not reported in cached trials |
| Diffuse large b-cell lymphoma | 360 | 26.5 23.8–29.4ROR 26.7 · calibrated p 5e-4 ✓ | 25.2 EB05 23.1 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious PRR 15.1 | not reported in cached trials |
Trial evidence (ClinicalTrials.gov)
✓ Trial adverse-event data found on ClinicalTrials.gov
Largest completed trials with posted results that list Gemcitabine 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 (0 of 40 signal terms matched).
- NCT00011986 — Combination Chemotherapy in Treating Patients With Stage III or Stage IV Ovarian Epithelial Cancer or Primary (N=4312, PHASE3; 127 AE terms posted; arms: Carbo/Taxol; Carbo/Taxol/Gemcitabine; Carbo/Taxol/Doxil; Carbo/Topotecan - Carbo/Taxol)
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 |
|---|---|---|---|---|---|---|
| Disease progression | 4,557 | 21.5 20.9–22.1ROR 24.2 · calibrated p 8e-4 ✓ | 20.7 EB05 20.2 · IC025 +4.3 3/3 methods agree | Reporting / coding artifact | serious PRR 13.9 · 97% clinician | not reported in cached trials |
| Thrombocytopenia (low platelets) | 2,968 | 14.6 14.1–15.1ROR 15.7 · calibrated p 0.006 ✓ | 14.2 EB05 13.8 · IC025 +3.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 8.7 · 96% clinician | NCT00011986: 645/851 (75.8%) on Gemcitabine |
| Off label use (used outside approved label) | 2,781 | 1.7 1.7–1.8ROR 1.8 · calibrated p 0.814 | 1.7 EB05 1.7 · IC025 +0.7 | Reporting / coding artifact | serious PRR 1.8 · 93% clinician | not reported in cached trials |
| Drug ineffective (drug did not work) | 2,655 | 1.1 1.0–1.1ROR 1.1 · calibrated p 0.363 | 1.1 EB05 1.0 · IC025 +0.0 | Reporting / coding artifact | serious PRR 1.8 · 96% clinician | not reported in cached trials |
| Neutropenia (low neutrophils (infection-fighting cells)) | 2,648 | 10.7 10.3–11.1ROR 11.4 · calibrated p 0.021 ✓ | 10.5 EB05 10.1 · IC025 +3.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.4 · 95% clinician | NCT00011986: 1/766 (0.1%) on Gemcitabine (serious AE) |
| Anaemia (low red blood cells) | 2,425 | 6.9 6.6–7.2ROR 7.3 · calibrated p 0.089 | 6.8 EB05 6.6 · IC025 +2.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.4 · 93% clinician | NCT00011986: 685/851 (80.5%) on Gemcitabine |
| Malignant neoplasm progression | 2,099 | 11.2 10.8–11.7ROR 11.8 · calibrated p 0.018 ✓ | 11.0 EB05 10.6 · IC025 +3.4 3/3 methods agree | Reporting / coding artifact | serious PRR 6.6 | not reported in cached trials |
| Nausea | 1,987 | 1.3 1.3–1.4ROR 1.4 · calibrated p 0.554 | 1.3 EB05 1.3 · IC025 +0.4 | Labeled adverse reaction exact term | serious PRR 1.5 · 92% clinician | NCT00011986: 1/767 (0.1%) on Gemcitabine (serious AE) |
| Pyrexia (fever) | 1,945 | 3.0 2.9–3.2ROR 3.1 · calibrated p 0.587 | 3.0 EB05 2.9 · IC025 +1.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 2.2 · 92% clinician | not reported in cached trials |
| Fatigue (tiredness) | 1,660 | 1.1 1.1–1.2ROR 1.2 · calibrated p 0.407 | 1.1 EB05 1.1 · IC025 +0.1 | Labeled adverse reaction exact term | serious PRR 1.2 | NCT00011986: 3/774 (0.4%) on Gemcitabine (serious AE) |
| Diarrhoea (diarrhea) | 1,642 | 1.4 1.3–1.4ROR 1.4 · calibrated p 0.565 | 1.4 EB05 1.3 · IC025 +0.4 | Labeled adverse reaction exact term | serious PRR 1.4 · 93% clinician | NCT00011986: 2/767 (0.3%) on Gemcitabine (serious AE) |
| Vomiting | 1,586 | 1.8 1.7–1.9ROR 1.8 · calibrated p 0.858 | 1.8 EB05 1.7 · IC025 +0.8 | Labeled adverse reaction exact term | serious PRR 1.6 · 93% clinician | NCT00011986: 1/767 (0.1%) on Gemcitabine (serious AE) |
| Death | 1,516 | 0.9 0.9–1.0ROR 0.9 · calibrated p 0.268 | 0.9 EB05 0.9 · IC025 -0.2 PRR-only: not supported by EBGM or IC | Outcome field, not a reaction | serious PRR 0.6 · 90% clinician | not reported in cached trials |
| Febrile neutropenia | 1,389 | 11.5 10.9–12.1ROR 11.8 · calibrated p 0.018 ✓ | 11.2 EB05 10.7 · IC025 +3.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.7 · 94% clinician | NCT00011986: 7/767 (0.9%) on Gemcitabine (serious AE) |
| Dyspnoea (shortness of breath) | 1,212 | 1.1 1.1–1.2ROR 1.2 · calibrated p 0.408 | 1.1 EB05 1.1 · IC025 +0.1 | Labeled adverse reaction exact term | serious PRR 0.9 | NCT00011986: 3/774 (0.4%) on Gemcitabine (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.
- Desmoplastic small round cell tumour — n=36, PRR 372.3
- Refractory cancer — n=51, PRR 165.0
- Pseudocirrhosis — n=68, PRR 140.1
- Diffuse large b-cell lymphoma recurrent — n=313, PRR 91.3
- Diffuse large b-cell lymphoma refractory — n=119, PRR 78.5
- Recall phenomenon — n=101, PRR 73.6
- Cholangitis infective — n=28, PRR 63.9
- Pik3ca-activated mutation — n=29, PRR 52.2
- Metastases to bone marrow — n=32, PRR 36.3
- Metastases to spleen — n=25, PRR 34.2
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 Gemcitabine?
In FDA FAERS, the most frequently co-reported reaction terms for Gemcitabine are thrombocytopenia, neutropenia, anaemia, nausea, pyrexia, fatigue. 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 Gemcitabine have an FDA boxed warning?
No. The FDA label retrieved for Gemcitabine has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Gemcitabine 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 a625c92b-c569-4b98-8d2e-2b3f5e12b34f, effective 20240816; matched on
openfda.generic_name.exact:"GEMCITABINE") - 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, 1,157 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
GEMCITABINE, 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.