Docetaxel side effects: what 67,001 FDA adverse event reports show
Drug class
Microtubule inhibitor
Who reports
67,001 reports · 78% serious · 8,845 with death outcome · 69% female
Used for
Docetaxel Injection is a microtubule inhibitor indicated for: Breast Cancer (BC): single agent for locally advanced or metastatic BC after chemotherapy failure; and with doxorubicin and cyclophosphamide as adjuvant treatment of operable node-positive B.
What it is
Docetaxel, USP is an antineoplastic agent belonging to the taxoid family. It is prepared by semisynthesis beginning with a precursor extracted from the renewable needle biomass of yew plants.
Boxed warning
TOXIC DEATHS, HEPATOTOXICITY, NEUTROPENIA, HYPERSENSITIVITY REACTIONS, and FLUID RETENTION Treatment-related mortality associated with Docetaxel Injection is increased in patients with abnormal liver function, in pat.
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). 1,166 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 |
|---|---|---|---|---|---|---|
| Lacrimal structure injury | 265 | 755.3 604.0–944.6ROR 758.3 · calibrated p 1e-15 ✓ | 216.0 EB05 195.0 · IC025 +7.1 3/3 methods agree | Not in label — unassessed | serious n=141 · ♀ 100% (drug 69%) | not reported in cached trials |
| Multifocal micronodular pneumocyte hyperplasia | 24 | 738.8 353.3–1,544.9ROR 739.1 · calibrated p 8e-13 ✓ | 185.9 EB05 131.5 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious n=24 · ♀ 100% (drug 69%) · 100% clinician | not reported in cached trials |
| Hair disorder | 5,625 | 665.5 635.7–696.7ROR 726.4 · calibrated p 1e-15 ✓ | 211.0 EB05 206.4 · IC025 +7.7 3/3 methods agree | Not in label — unassessed | serious n=114 · ♀ 100% (drug 69%) | not reported in cached trials |
| Bronchial polyp | 24 | 568.3 289.4–1,116.1ROR 568.5 · calibrated p 3e-12 ✓ | 173.0 EB05 122.3 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious n=24 · ♀ 100% (drug 69%) · 92% clinician | not reported in cached trials |
| Madarosis | 6,717 | 427.4 412.2–443.1ROR 474.9 · calibrated p 1e-13 ✓ | 179.4 EB05 175.9 · IC025 +7.4 3/3 methods agree | Not in label — unassessed | serious n=377 · ♀ 100% (drug 69%) · 96% consumer | not reported in cached trials |
| Hair colour changes | 5,874 | 276.5 267.1–286.2ROR 303.0 · calibrated p 9e-12 ✓ | 146.1 EB05 143.0 · IC025 +7.1 3/3 methods agree | Not in label — unassessed | serious n=313 · ♀ 100% (drug 69%) | not reported in cached trials |
| Hair texture abnormal | 5,993 | 251.9 243.7–260.5ROR 276.6 · calibrated p 2e-11 ✓ | 138.9 EB05 136.0 · IC025 +7.1 3/3 methods agree | Not in label — unassessed | serious n=329 · ♀ 100% (drug 69%) · 100% consumer | not reported in cached trials |
| Desmoplastic small round cell tumour | 37 | 227.8 148.9–348.4ROR 227.9 · calibrated p 7e-10 ✓ | 123.1 EB05 93.3 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious n=37 · ♀ 100% (drug 69%) · 100% clinician | not reported in cached trials |
| Biopsy lung abnormal | 38 | 188.7 126.0–282.5ROR 188.8 · calibrated p 3e-9 ✓ | 110.9 EB05 84.4 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious n=38 · ♀ 100% (drug 69%) · 92% clinician | not reported in cached trials |
| Amaurosis fugax | 232 | 86.7 74.9–100.2ROR 87.0 · calibrated p 4e-7 ✓ | 67.5 EB05 60.5 · IC025 +5.7 3/3 methods agree | Not in label — unassessed | serious n=232 · 93% clinician | not reported in cached trials |
| Nail toxicity | 63 | 84.0 63.5–110.9ROR 84.0 · calibrated p 7e-7 ✓ | 64.9 EB05 52.6 · IC025 +5.0 3/3 methods agree | Labeled (related wording) related wording | serious n=62 · 95% clinician | not reported in cached trials |
| Dacryostenosis acquired | 246 | 73.2 63.7–84.1ROR 73.5 · calibrated p 1e-6 ✓ | 59.1 EB05 53.2 · IC025 +5.5 3/3 methods agree | Not in label — unassessed | serious n=167 · ♀ 90% (drug 69%) | not reported in cached trials |
| Alopecia areata | 290 | 61.9 54.5–70.2ROR 62.1 · calibrated p 4e-6 ✓ | 51.5 EB05 46.7 · IC025 +5.4 3/3 methods agree | Not in label — unassessed | serious n=196 · ♀ 100% (drug 69%) | not reported in cached trials |
| Hormone-refractory prostate cancer | 186 | 58.9 50.4–68.9ROR 59.1 · calibrated p 5e-6 ✓ | 49.4 EB05 43.7 · IC025 +5.2 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=185 · ♀ 0% (drug 69%) · 96% clinician | not reported in cached trials |
| Her2 positive breast cancer | 57 | 57.2 43.1–75.8ROR 57.2 · calibrated p 8e-6 ✓ | 47.6 EB05 38.1 · IC025 +4.7 3/3 methods agree | Likely indication confounding term in indications | serious n=57 · ♀ 100% (drug 69%) · 100% clinician | not reported in cached trials |
| Alopecia totalis | 49 | 54.1 39.9–73.2ROR 54.1 · calibrated p 1e-5 ✓ | 45.4 EB05 35.7 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious n=48 · ♀ 100% (drug 69%) | not reported in cached trials |
| Delusion of grandeur | 66 | 54.0 41.6–70.2ROR 54.1 · calibrated p 1e-5 ✓ | 45.5 EB05 37.1 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious n=66 · ♀ 0% (drug 69%) | not reported in cached trials |
| Recall phenomenon | 117 | 50.9 41.8–61.9ROR 51.0 · calibrated p 1e-5 ✓ | 43.5 EB05 37.3 · IC025 +4.9 3/3 methods agree | Labeled adverse reaction exact term | serious n=113 · 100% clinician | not reported in cached trials |
| Aortitis | 91 | 48.1 38.6–60.0ROR 48.2 · calibrated p 2e-5 ✓ | 41.4 EB05 34.8 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious n=91 · ♀ 89% (drug 69%) · 100% clinician | not reported in cached trials |
| Metastases to soft tissue | 32 | 43.6 30.1–63.1ROR 43.6 · calibrated p 6e-5 ✓ | 37.5 EB05 27.8 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious n=32 | not reported in cached trials |
| Oesophageal fistula | 37 | 41.1 29.2–57.9ROR 41.1 · calibrated p 7e-5 ✓ | 35.8 EB05 27.1 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious n=37 · ♀ 0% (drug 69%) · 100% clinician | not reported in cached trials |
| Pseudocirrhosis | 36 | 38.5 27.2–54.4ROR 38.5 · calibrated p 1e-4 ✓ | 33.8 EB05 25.5 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious n=36 · ♀ 100% (drug 69%) · 100% clinician | not reported in cached trials |
| Metastases to skin | 111 | 38.0 31.2–46.2ROR 38.0 · calibrated p 8e-5 ✓ | 33.7 EB05 28.8 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious n=111 · 95% clinician | not reported in cached trials |
| Portal venous gas | 37 | 36.6 26.0–51.5ROR 36.6 · calibrated p 1e-4 ✓ | 32.3 EB05 24.5 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious n=37 · ♀ 0% (drug 69%) · 100% clinician | not reported in cached trials |
| Neutropenic infection | 100 | 36.0 29.3–44.3ROR 36.1 · calibrated p 1e-4 ✓ | 32.2 EB05 27.2 · IC025 +4.5 3/3 methods agree | Labeled adverse reaction exact term | serious n=100 | not reported in cached trials |
| Mucosal infection | 23 | 34.0 22.1–52.4ROR 34.1 · calibrated p 2e-4 ✓ | 30.1 EB05 21.1 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious n=23 · 100% clinician | not reported in cached trials |
| Deformity | 915 | 33.8 31.6–36.2ROR 34.2 · calibrated p 1e-4 ✓ | 30.5 EB05 28.9 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious PRR 1.3 · ♀ 100% (drug 69%) · 100% consumer | not reported in cached trials |
| Nail dystrophy | 54 | 33.6 25.4–44.6ROR 33.7 · calibrated p 2e-4 ✓ | 30.1 EB05 24.0 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious n=53 · ♀ 100% (drug 69%) · 94% clinician | not reported in cached trials |
| Toxic erythema of chemotherapy | 23 | 33.4 21.7–51.4ROR 33.4 · calibrated p 3e-4 ✓ | 29.6 EB05 20.7 · IC025 +3.5 3/3 methods agree | Labeled (related wording) related wording | 100% clinician | not reported in cached trials |
| Pik3ca-activated mutation | 31 | 32.8 22.6–47.5ROR 32.8 · calibrated p 3e-4 ✓ | 29.3 EB05 21.6 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious n=31 · ♀ 100% (drug 69%) · 100% clinician | not reported in cached trials |
| Nail bed inflammation | 30 | 32.5 22.3–47.4ROR 32.5 · calibrated p 3e-4 ✓ | 29.0 EB05 21.3 · IC025 +3.7 3/3 methods agree | Labeled (related wording) related wording | serious n=29 · ♀ 100% (drug 69%) · 90% clinician | not reported in cached trials |
| Retinitis pigmentosa | 25 | 32.5 21.5–49.0ROR 32.5 · calibrated p 3e-4 ✓ | 28.9 EB05 20.6 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious n=25 · ♀ 100% (drug 69%) · 100% clinician | not reported in cached trials |
| Metastases to the mediastinum | 39 | 32.4 23.3–45.0ROR 32.4 · calibrated p 3e-4 ✓ | 29.0 EB05 22.1 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious n=39 | not reported in cached trials |
| Onycholysis | 145 | 32.2 27.1–38.2ROR 32.2 · calibrated p 2e-4 ✓ | 29.1 EB05 25.3 · IC025 +4.5 3/3 methods agree | Labeled adverse reaction exact term | serious n=136 · 91% clinician | not reported in cached trials |
| Psychological trauma | 787 | 30.9 28.7–33.2ROR 31.3 · calibrated p 2e-4 ✓ | 28.2 EB05 26.5 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious PRR 20.8 · ♀ 100% (drug 69%) · 100% consumer | not reported in cached trials |
| Gastrointestinal anastomotic leak | 34 | 29.6 20.8–42.0ROR 29.6 · calibrated p 4e-4 ✓ | 26.7 EB05 20.0 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious n=34 · ♀ 0% (drug 69%) · 100% clinician | not reported in cached trials |
| Alopecia (hair loss) | 16,970 | 29.5 29.1–29.9ROR 39.1 · calibrated p 6e-5 ✓ | 27.0 EB05 26.7 · IC025 +4.7 3/3 methods agree | Labeled adverse reaction exact term | age-adj. PRR 19.8 · serious PRR 11.7 · ♀ 97% (drug 69%) · 80% consumer | not reported in cached trials |
| Metastases to pleura | 89 | 29.2 23.5–36.3ROR 29.2 · calibrated p 4e-4 ✓ | 26.6 EB05 22.3 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious n=89 · 100% clinician | not reported in cached trials |
| Radiation skin injury | 98 | 28.8 23.4–35.4ROR 28.8 · calibrated p 4e-4 ✓ | 26.3 EB05 22.2 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious n=93 | not reported in cached trials |
| Ejection fraction | 47 | 27.3 20.3–36.8ROR 27.3 · calibrated p 6e-4 ✓ | 24.9 EB05 19.5 · IC025 +3.8 3/3 methods agree | Labeled adverse reaction exact term | serious n=47 · ♀ 100% (drug 69%) | 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 | 7,174 | 9.39.1–9.5 | signal |
| Interstitial lung disease | 1,659 | 5.55.2–5.8 | signal |
| Osteonecrosis | 650 | 3.63.3–3.8 | signal |
| Anaemia | 2,682 | 2.82.7–2.9 | signal |
| Thrombocytopenia | 1,956 | 2.82.7–2.9 | signal |
| Heart failure | 1,260 | 2.22.1–2.3 | signal |
| Hyponatraemia | 558 | 2.22.0–2.4 | signal |
| Liver injury | 1,648 | 1.71.6–1.8 | raised |
| Serious infection | 4,107 | 1.71.6–1.7 | raised |
| Venous thromboembolism | 1,026 | 1.51.4–1.6 | raised |
| Gi bleeding | 851 | 1.51.4–1.6 | raised |
| Depression | 1,017 | 1.11.1–1.2 | raised |
| Kidney injury | 1,611 | 1.11.1–1.2 | raised |
| Severe cutaneous reaction | 229 | 1.00.8–1.1 | no difference |
| Arrhythmia / qt | 578 | 0.90.9–1.0 | no difference |
| Rhabdomyolysis / myopathy | 228 | 0.90.8–1.0 | no difference |
Trial evidence (ClinicalTrials.gov)
✓ Trial adverse-event data found on ClinicalTrials.gov
Largest completed trials with posted results that list Docetaxel 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).
- NCT00003782 — Combination Chemotherapy in Treating Women With Stage I, Stage II, or Stage IIIA (cT1-3, N0-1, M0) Breast Canc (N=5351, PHASE3; 64 AE terms posted; arms: Doxorubicin + Cyclophosphamide, Then Doc; Doxorubicin + Docetaxel; Doxorubicin + Docetaxel + Cyclophosphami)
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 |
|---|---|---|---|---|---|---|
| Alopecia (hair loss) | 16,970 | 29.5 29.1–29.9ROR 39.1 · calibrated p 6e-5 ✓ | 27.0 EB05 26.7 · IC025 +4.7 3/3 methods agree | Labeled adverse reaction exact term | age-adj. PRR 19.8 · serious PRR 11.7 · ♀ 97% (drug 69%) · 80% consumer | not reported in cached trials |
| Madarosis | 6,717 | 427.4 412.2–443.1ROR 474.9 · calibrated p 1e-13 ✓ | 179.4 EB05 175.9 · IC025 +7.4 3/3 methods agree | Not in label — unassessed | serious n=377 · ♀ 100% (drug 69%) · 96% consumer | not reported in cached trials |
| Hair texture abnormal | 5,993 | 251.9 243.7–260.5ROR 276.6 · calibrated p 2e-11 ✓ | 138.9 EB05 136.0 · IC025 +7.1 3/3 methods agree | Not in label — unassessed | serious n=329 · ♀ 100% (drug 69%) · 100% consumer | not reported in cached trials |
| Hair colour changes | 5,874 | 276.5 267.1–286.2ROR 303.0 · calibrated p 9e-12 ✓ | 146.1 EB05 143.0 · IC025 +7.1 3/3 methods agree | Not in label — unassessed | serious n=313 · ♀ 100% (drug 69%) | not reported in cached trials |
| Hair disorder | 5,625 | 665.5 635.7–696.7ROR 726.4 · calibrated p 1e-15 ✓ | 211.0 EB05 206.4 · IC025 +7.7 3/3 methods agree | Not in label — unassessed | serious n=114 · ♀ 100% (drug 69%) | not reported in cached trials |
| Diarrhoea (diarrhea) | 5,239 | 2.6 2.5–2.6ROR 2.7 · calibrated p 0.734 | 2.5 EB05 2.5 · IC025 +1.3 3/3 methods agree | Labeled adverse reaction exact term | age-adj. PRR 2.4 · serious PRR 3.2 · 94% clinician | NCT00003782: 1/1,745 (0.1%) on Docetaxel (serious AE) |
| Nausea | 3,814 | 1.5 1.5–1.6ROR 1.5 · calibrated p 0.672 | 1.5 EB05 1.5 · IC025 +0.5 | Labeled adverse reaction exact term | age-adj. PRR 1.4 · serious PRR 2.1 · 92% clinician | NCT00003782: 155/1,745 (8.9%) on Docetaxel |
| Emotional distress | 3,615 | 9.6 9.3–9.9ROR 10.1 · calibrated p 0.032 ✓ | 9.3 EB05 9.1 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | age-adj. PRR 2.9 · serious PRR 1.2 · ♀ 100% (drug 69%) · 100% consumer | not reported in cached trials |
| Anxiety | 3,456 | 3.8 3.7–4.0ROR 4.0 · calibrated p 0.381 | 3.8 EB05 3.7 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | age-adj. PRR 1.4 · serious PRR 0.8 · ♀ 97% (drug 69%) · 90% consumer | NCT00003782: 1/1,745 (0.1%) on Docetaxel (serious AE) |
| Neutropenia (low neutrophils (infection-fighting cells)) | 3,370 | 8.0 7.7–8.2ROR 8.3 · calibrated p 0.059 | 7.8 EB05 7.6 · IC025 +2.9 3/3 methods agree | Labeled — boxed warning exact term | age-adj. PRR 6.4 · serious PRR 5.9 · 95% clinician | NCT00003782: 7/1,745 (0.4%) on Docetaxel (serious AE) |
| Fatigue (tiredness) | 3,241 | 1.3 1.3–1.4ROR 1.3 · calibrated p 0.523 | 1.3 EB05 1.3 · IC025 +0.3 | Labeled adverse reaction exact term | age-adj. PRR 1.1 · serious PRR 1.8 | NCT00003782: 167/1,745 (9.6%) on Docetaxel |
| Febrile neutropenia | 3,074 | 15.2 14.7–15.7ROR 15.9 · calibrated p 0.005 ✓ | 14.5 EB05 14.1 · IC025 +3.8 3/3 methods agree | Labeled — boxed warning exact term | age-adj. PRR 12.6 · serious PRR 10.7 · 95% clinician | NCT00003782: 7/1,745 (0.4%) on Docetaxel (serious AE) |
| Vomiting | 2,777 | 1.9 1.8–1.9ROR 1.9 · calibrated p 0.886 | 1.9 EB05 1.8 · IC025 +0.8 | Labeled adverse reaction exact term | age-adj. PRR 1.6 · serious PRR 2.0 · 94% clinician | NCT00003782: 1/1,748 (0.1%) on Docetaxel (serious AE) |
| Malignant neoplasm progression | 2,765 | 8.7 8.4–9.0ROR 9.0 · calibrated p 0.045 ✓ | 8.5 EB05 8.2 · IC025 +3.0 3/3 methods agree | Reporting / coding artifact | age-adj. PRR 8.7 · serious PRR 6.4 · ♀ 45% (drug 69%) | not reported in cached trials |
| Disease progression | 2,655 | 7.2 6.9–7.5ROR 7.4 · calibrated p 0.083 | 7.0 EB05 6.8 · IC025 +2.8 3/3 methods agree | Reporting / coding artifact | age-adj. PRR 7.2 · serious PRR 5.8 · 96% clinician | not reported in cached trials |
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.
- Lacrimal structure injury — n=265, PRR 755.3
- Multifocal micronodular pneumocyte hyperplasia — n=24, PRR 738.8
- Hair disorder — n=5,625, PRR 665.5
- Bronchial polyp — n=24, PRR 568.3
- Madarosis — n=6,717, PRR 427.4
- Hair colour changes — n=5,874, PRR 276.5
- Hair texture abnormal — n=5,993, PRR 251.9
- Desmoplastic small round cell tumour — n=37, PRR 227.8
- Biopsy lung abnormal — n=38, PRR 188.7
- Amaurosis fugax — n=232, PRR 86.7
✓ A hand-written Bradford Hill causality assessment exists for this drug: Docetaxel (taxanes) ↔ Alopecia.
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 Docetaxel?
In FDA FAERS, the most frequently co-reported reaction terms for Docetaxel are alopecia, madarosis, hair texture abnormal, hair colour changes, hair disorder, diarrhoea. 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 Docetaxel have an FDA boxed warning?
Yes. The current FDA label carries a boxed warning: TOXIC DEATHS, HEPATOTOXICITY, NEUTROPENIA, HYPERSENSITIVITY REACTIONS, and FLUID RETENTION Treatment-related mortality associated with Docetaxel Injection is increased in patients with abnormal liver function, in pat.
Do FAERS signals prove that Docetaxel 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 2c806400-5fdc-4398-8475-37f700b3191f, effective 20240801; matched on
openfda.generic_name.exact:"DOCETAXEL") - 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, 1,206 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
DOCETAXEL, 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.