Paclitaxel side effects: what 98,446 FDA adverse event reports show
Drug class
Microtubule Inhibitor
Who reports
98,446 reports · 96% serious · 16,308 with death outcome · 71% female
Used for
Paclitaxel Injection, USP is indicated as subsequent therapy for the treatment of advanced carcinoma of the ovary. As first-line therapy, Paclitaxel Injection, USP is indicated in combination with cisplatin. Paclitaxel Injection, USP is indicated for the adjuvant treatment of node-positive breast cancer administered sequentially to standard doxorubicin-containing combination chemotherapy.
What it is
DESCRIPTION Paclitaxel Injection, USP is a clear, colorless to slightly yellow viscous solution. It is supplied as a nonaqueous solution intended for dilution with a suitable parenteral fluid prior to intravenous infusion.
Boxed warning
Paclitaxel should be administered under the supervision of a physician experienced in the use of cancer chemotherapeutic agents. Appropriate management of complications is possible only when adequate diagnostic and treatment facilities are readily available.
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). 1,252 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 |
|---|---|---|---|---|---|---|
| Computerised tomogram thorax | 39 | 388.5 228.5–660.3ROR 388.6 · calibrated p 2e-11 ✓ | 128.2 EB05 97.8 · IC025 +5.1 3/3 methods agree | Not in label — unassessed | serious n=39 · ♀ 100% (drug 71%) · 100% clinician | not reported in cached trials |
| Pseudocirrhosis | 136 | 151.3 121.4–188.7ROR 151.5 · calibrated p 6e-9 ✓ | 87.2 EB05 75.6 · IC025 +5.8 3/3 methods agree | Not in label — unassessed | serious n=136 · ♀ 100% (drug 71%) · 96% clinician | not reported in cached trials |
| Pik3ca-activated mutation | 89 | 79.9 62.6–102.0ROR 80.0 · calibrated p 8e-7 ✓ | 57.4 EB05 48.1 · IC025 +5.1 3/3 methods agree | Not in label — unassessed | serious n=89 · ♀ 100% (drug 71%) · 94% clinician | not reported in cached trials |
| Urogenital fistula | 63 | 78.4 58.7–104.8ROR 78.5 · calibrated p 1e-6 ✓ | 56.4 EB05 45.6 · IC025 +4.9 3/3 methods agree | Not in label — unassessed | serious n=63 · ♀ 100% (drug 71%) · 100% clinician | not reported in cached trials |
| Cervix carcinoma recurrent | 45 | 76.5 54.4–107.7ROR 76.6 · calibrated p 2e-6 ✓ | 55.1 EB05 42.8 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious n=44 · 100% clinician | not reported in cached trials |
| Nail toxicity | 71 | 66.6 51.0–87.0ROR 66.6 · calibrated p 3e-6 ✓ | 50.1 EB05 41.1 · IC025 +4.8 3/3 methods agree | Labeled (related wording) related wording | serious n=69 · ♀ 100% (drug 71%) · 93% clinician | not reported in cached trials |
| Immune-mediated adrenal insufficiency | 170 | 61.8 52.1–73.4ROR 61.9 · calibrated p 4e-6 ✓ | 47.7 EB05 42.0 · IC025 +5.1 3/3 methods agree | Not in label — unassessed | serious n=170 · 100% clinician | not reported in cached trials |
| Immune-mediated hyperthyroidism | 52 | 59.1 43.5–80.4ROR 59.1 · calibrated p 7e-6 ✓ | 45.6 EB05 36.1 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious n=52 · 100% clinician | not reported in cached trials |
| Biliary tract infection | 110 | 46.7 38.0–57.4ROR 46.7 · calibrated p 2e-5 ✓ | 38.1 EB05 32.5 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious n=110 | not reported in cached trials |
| Her2 positive breast cancer | 65 | 45.5 34.8–59.5ROR 45.5 · calibrated p 3e-5 ✓ | 37.2 EB05 30.2 · IC025 +4.5 3/3 methods agree | Likely indication confounding term in indications | serious n=65 · ♀ 100% (drug 71%) · 100% clinician | not reported in cached trials |
| Hepatic atrophy | 70 | 39.2 30.3–50.5ROR 39.2 · calibrated p 8e-5 ✓ | 32.9 EB05 26.9 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious n=70 · ♀ 100% (drug 71%) · 90% clinician | not reported in cached trials |
| Immune-mediated hypothyroidism | 167 | 39.1 33.1–46.1ROR 39.1 · calibrated p 7e-5 ✓ | 33.0 EB05 29.0 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious n=167 · 100% clinician | not reported in cached trials |
| Immune-mediated dermatitis | 145 | 38.9 32.6–46.5ROR 39.0 · calibrated p 7e-5 ✓ | 32.9 EB05 28.6 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious n=144 · 96% clinician | not reported in cached trials |
| Immune-mediated hypophysitis | 61 | 35.2 26.9–46.2ROR 35.3 · calibrated p 1e-4 ✓ | 30.1 EB05 24.2 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious n=61 · 100% clinician | not reported in cached trials |
| Immune-mediated pancreatitis | 49 | 32.5 24.1–44.0ROR 32.6 · calibrated p 2e-4 ✓ | 28.0 EB05 22.0 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious n=49 · 100% clinician | not reported in cached trials |
| Radiation oesophagitis | 50 | 32.2 23.9–43.3ROR 32.2 · calibrated p 2e-4 ✓ | 27.8 EB05 21.9 · IC025 +4.0 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=50 · ♀ 0% (drug 71%) · 100% clinician | not reported in cached trials |
| Metastases to the mediastinum | 53 | 31.1 23.3–41.4ROR 31.1 · calibrated p 3e-4 ✓ | 26.9 EB05 21.4 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious n=53 | not reported in cached trials |
| Immune-mediated hepatitis | 249 | 30.8 27.0–35.2ROR 30.9 · calibrated p 2e-4 ✓ | 27.0 EB05 24.3 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious n=249 · 97% clinician | not reported in cached trials |
| Immune-mediated lung disease | 221 | 30.7 26.7–35.4ROR 30.8 · calibrated p 2e-4 ✓ | 26.9 EB05 24.0 · IC025 +4.4 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=221 · ♀ 44% (drug 71%) · 100% clinician | not reported in cached trials |
| Metastases to skin | 129 | 30.6 25.4–36.8ROR 30.6 · calibrated p 3e-4 ✓ | 26.7 EB05 23.1 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious n=128 | not reported in cached trials |
| Delusion of grandeur | 56 | 30.3 22.9–40.2ROR 30.4 · calibrated p 3e-4 ✓ | 26.4 EB05 21.1 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious n=56 · ♀ 0% (drug 71%) | not reported in cached trials |
| Immune-mediated hepatic disorder | 239 | 30.3 26.5–34.7ROR 30.4 · calibrated p 3e-4 ✓ | 26.6 EB05 23.9 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious n=238 · 100% clinician | not reported in cached trials |
| Cystoid macular oedema | 227 | 29.5 25.7–33.9ROR 29.6 · calibrated p 3e-4 ✓ | 25.9 EB05 23.2 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious n=227 · 97% clinician | not reported in cached trials |
| Triple negative breast cancer | 75 | 28.7 22.6–36.6ROR 28.8 · calibrated p 4e-4 ✓ | 25.2 EB05 20.8 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious n=74 · ♀ 100% (drug 71%) · 100% clinician | not reported in cached trials |
| Glucocorticoid deficiency | 49 | 28.4 21.1–38.3ROR 28.4 · calibrated p 5e-4 ✓ | 24.9 EB05 19.6 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious n=49 · ♀ 100% (drug 71%) · 100% clinician | not reported in cached trials |
| Computerised tomogram thorax abnormal | 82 | 28.3 22.5–35.6ROR 28.3 · calibrated p 4e-4 ✓ | 24.9 EB05 20.7 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious n=82 · ♀ 100% (drug 71%) · 94% clinician | not reported in cached trials |
| Pancreatic carcinoma metastatic | 333 | 28.0 25.0–31.4ROR 28.1 · calibrated p 4e-4 ✓ | 24.8 EB05 22.6 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious n=331 · ♀ 38% (drug 71%) · 93% clinician | not reported in cached trials |
| Peripheral sensory neuropathy | 677 | 27.8 25.7–30.1ROR 28.0 · calibrated p 4e-4 ✓ | 24.6 EB05 23.1 · IC025 +4.5 3/3 methods agree | Labeled (related wording) related wording | serious n=668 · 96% clinician | not reported in cached trials |
| Adrenocorticotropic hormone deficiency | 99 | 27.2 22.0–33.5ROR 27.2 · calibrated p 5e-4 ✓ | 24.1 EB05 20.3 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious n=99 · 95% clinician | not reported in cached trials |
| Onycholysis | 169 | 25.9 22.1–30.4ROR 26.0 · calibrated p 6e-4 ✓ | 23.1 EB05 20.3 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious n=161 · 97% clinician | not reported in cached trials |
| Immune-mediated renal disorder | 42 | 25.5 18.5–35.2ROR 25.5 · calibrated p 8e-4 ✓ | 22.7 EB05 17.5 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious n=42 · 100% clinician | not reported in cached trials |
| Immune-mediated encephalitis | 53 | 25.4 19.1–33.8ROR 25.4 · calibrated p 8e-4 ✓ | 22.6 EB05 17.9 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious n=53 · 100% clinician | not reported in cached trials |
| Myelosuppression | 3,569 | 24.9 24.0–25.7ROR 25.8 · calibrated p 6e-4 ✓ | 22.3 EB05 21.7 · IC025 +4.4 3/3 methods agree | Labeled adverse reaction exact term | age-adj. PRR 18.0 · serious PRR 13.3 · 95% clinician | not reported in cached trials |
| Immune-mediated nephritis | 46 | 24.0 17.7–32.6ROR 24.0 · calibrated p 0.001 ✓ | 21.5 EB05 16.7 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious n=46 · 100% clinician | not reported in cached trials |
| Metastases to pleura | 105 | 23.8 19.4–29.1ROR 23.8 · calibrated p 1e-3 ✓ | 21.4 EB05 18.2 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious n=105 · 92% clinician | not reported in cached trials |
| Bronchopleural fistula | 38 | 23.7 16.9–33.1ROR 23.7 · calibrated p 0.001 ✓ | 21.2 EB05 16.1 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious n=37 · ♀ 0% (drug 71%) · 100% clinician | not reported in cached trials |
| Biliary sepsis | 46 | 23.5 17.3–31.8ROR 23.5 · calibrated p 0.001 ✓ | 21.0 EB05 16.4 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious n=46 · 91% clinician | not reported in cached trials |
| Immune-mediated thyroiditis | 46 | 23.1 17.0–31.3ROR 23.1 · calibrated p 0.001 ✓ | 20.7 EB05 16.2 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious n=46 · 100% clinician | not reported in cached trials |
| Radiation pneumonitis | 200 | 21.8 18.9–25.3ROR 21.9 · calibrated p 0.001 ✓ | 19.8 EB05 17.6 · IC025 +4.0 3/3 methods agree | Labeled adverse reaction exact term | serious n=198 · ♀ 41% (drug 71%) · 92% clinician | not reported in cached trials |
| Metastases to peritoneum | 233 | 21.8 19.0–24.9ROR 21.8 · calibrated p 0.001 ✓ | 19.8 EB05 17.7 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious n=232 · 90% 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 | 10,645 | 9.59.4–9.7 | signal |
| Interstitial lung disease | 3,282 | 7.57.3–7.8 | signal |
| Thrombocytopenia | 4,700 | 4.64.5–4.8 | signal |
| Anaemia | 5,704 | 4.14.0–4.2 | signal |
| Hyponatraemia | 1,102 | 2.92.8–3.1 | signal |
| Liver injury | 3,781 | 2.72.6–2.8 | signal |
| Anaphylaxis / angioedema | 1,562 | 2.72.5–2.8 | signal |
| Heart failure | 1,688 | 2.01.9–2.1 | raised |
| Severe cutaneous reaction | 701 | 2.01.9–2.2 | raised |
| Venous thromboembolism | 2,003 | 2.01.9–2.1 | raised |
| Osteonecrosis | 495 | 1.81.7–2.0 | raised |
| Serious infection | 6,243 | 1.71.7–1.8 | raised |
| Kidney injury | 3,182 | 1.51.4–1.5 | raised |
| Gi bleeding | 1,034 | 1.21.1–1.3 | raised |
| Rhabdomyolysis / myopathy | 458 | 1.21.1–1.3 | raised |
| Arrhythmia / qt | 946 | 1.01.0–1.1 | no difference |
Trial evidence (ClinicalTrials.gov)
✓ Trial adverse-event data found on ClinicalTrials.gov
Largest completed trials with posted results that list Paclitaxel 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).
- NCT00433511 — Doxorubicin Hydrochloride, Cyclophosphamide, and Paclitaxel With or Without Bevacizumab in Treating Patients W (N=4994, PHASE3; 350 AE terms posted; arms: Arm A (Chemo + Placebo); Arm B (Chemo + Bevacizumab); Arm C (Chemo + Bevacizumab Then Bevacizu; Arm D (Bevacizumab Cycles 9-18 of Arm C))
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 |
|---|---|---|---|---|---|---|
| Nausea | 5,498 | 1.5 1.4–1.5ROR 1.5 · calibrated p 0.652 | 1.5 EB05 1.5 · IC025 +0.5 | Labeled adverse reaction exact term | age-adj. PRR 1.3 · serious PRR 1.7 · 92% clinician | NCT00433511: 54/1,922 (2.8%) on Paclitaxel; 25/972 (2.6%) control (serious AE) |
| Neutropenia (low neutrophils (infection-fighting cells)) | 5,421 | 8.8 8.6–9.1ROR 9.3 · calibrated p 0.041 ✓ | 8.5 EB05 8.3 · IC025 +3.0 3/3 methods agree | Labeled — boxed warning exact term | age-adj. PRR 6.5 · serious PRR 5.3 · 95% clinician | NCT00433511: 7/1,922 (0.4%) on Paclitaxel; 6/972 (0.6%) control (serious AE) |
| Off label use (used outside approved label) | 5,199 | 1.3 1.2–1.3ROR 1.3 · calibrated p 0.503 | 1.3 EB05 1.2 · IC025 +0.3 | Reporting / coding artifact | age-adj. PRR 1.2 · serious PRR 1.3 | not reported in cached trials |
| Diarrhoea (diarrhea) | 5,151 | 1.7 1.7–1.8ROR 1.8 · calibrated p 0.800 | 1.7 EB05 1.7 · IC025 +0.7 | Labeled adverse reaction exact term | age-adj. PRR 1.4 · serious PRR 1.7 · 92% clinician | NCT00433511: 66/1,922 (3.4%) on Paclitaxel; 29/972 (3.0%) control (serious AE) |
| Dyspnoea (shortness of breath) | 5,112 | 1.9 1.9–2.0ROR 2.0 · calibrated p 0.936 | 1.9 EB05 1.9 · IC025 +0.9 | Labeled — boxed warning exact term | age-adj. PRR 1.7 · serious PRR 1.5 · 93% clinician | NCT00433511: 60/1,922 (3.1%) on Paclitaxel; 32/972 (3.3%) control (serious AE) |
| Anaemia (low red blood cells) | 4,794 | 5.5 5.3–5.6ROR 5.7 · calibrated p 0.172 | 5.3 EB05 5.2 · IC025 +2.4 3/3 methods agree | Labeled adverse reaction exact term | age-adj. PRR 4.1 · serious PRR 3.5 · 94% clinician | NCT00433511: 32/1,922 (1.7%) on Paclitaxel; 15/972 (1.5%) control (serious AE) |
| Death | 4,451 | 1.1 1.1–1.1ROR 1.1 · calibrated p 0.377 | 1.1 EB05 1.1 · IC025 +0.1 | Outcome field, not a reaction boxed warning mentions mortality | age-adj. PRR 0.8 · serious PRR 0.7 | NCT00433511: 2/1,922 (0.1%) on Paclitaxel (serious AE) |
| Malignant neoplasm progression | 4,345 | 9.4 9.2–9.7ROR 9.8 · calibrated p 0.034 ✓ | 9.1 EB05 8.9 · IC025 +3.1 3/3 methods agree | Reporting / coding artifact | age-adj. PRR 7.7 · serious PRR 5.5 | not reported in cached trials |
| Fatigue (tiredness) | 4,223 | 1.2 1.1–1.2ROR 1.2 · calibrated p 0.417 | 1.2 EB05 1.1 · IC025 +0.2 | Labeled (related wording) related wording | age-adj. PRR 1.0 · serious PRR 1.3 | NCT00433511: 188/1,922 (9.8%) on Paclitaxel; 66/972 (6.8%) control (serious AE) |
| Neuropathy peripheral (nerve damage in hands/feet) | 3,933 | 9.2 8.9–9.5ROR 9.5 · calibrated p 0.038 ✓ | 8.9 EB05 8.6 · IC025 +3.1 3/3 methods agree | Labeled (related wording) related wording | age-adj. PRR 8.1 · serious PRR 6.0 · 90% clinician | not reported in cached trials |
| Pyrexia (fever) | 3,903 | 2.4 2.3–2.5ROR 2.5 · calibrated p 0.823 | 2.4 EB05 2.3 · IC025 +1.2 3/3 methods agree | Labeled (related wording) related wording | age-adj. PRR 2.1 · serious PRR 1.8 · 92% clinician | not reported in cached trials |
| Disease progression | 3,878 | 7.2 7.0–7.4ROR 7.5 · calibrated p 0.082 | 7.0 EB05 6.8 · IC025 +2.8 3/3 methods agree | Reporting / coding artifact | age-adj. PRR 5.9 · serious PRR 4.7 · 95% clinician | NCT00433511: 1/1,922 (0.1%) on Paclitaxel; 4/972 (0.4%) control (serious AE) |
| Vomiting | 3,816 | 1.7 1.7–1.8ROR 1.8 · calibrated p 0.812 | 1.7 EB05 1.7 · IC025 +0.7 | Labeled adverse reaction exact term | age-adj. PRR 1.4 · serious PRR 1.5 · 92% clinician | NCT00433511: 49/1,922 (2.5%) on Paclitaxel; 15/972 (1.5%) control (serious AE) |
| Febrile neutropenia | 3,716 | 12.6 12.2–13.0ROR 13.1 · calibrated p 0.012 ✓ | 11.9 EB05 11.6 · IC025 +3.5 3/3 methods agree | Labeled — boxed warning synonym match | age-adj. PRR 9.9 · serious PRR 7.1 · 94% clinician | NCT00433511: 77/1,922 (4.0%) on Paclitaxel; 33/972 (3.4%) control (serious AE) |
| Myelosuppression | 3,569 | 24.9 24.0–25.7ROR 25.8 · calibrated p 6e-4 ✓ | 22.3 EB05 21.7 · IC025 +4.4 3/3 methods agree | Labeled adverse reaction exact term | age-adj. PRR 18.0 · serious PRR 13.3 · 95% 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.
- Computerised tomogram thorax — n=39, PRR 388.5
- Pseudocirrhosis — n=136, PRR 151.3
- Pik3ca-activated mutation — n=89, PRR 79.9
- Urogenital fistula — n=63, PRR 78.4
- Cervix carcinoma recurrent — n=45, PRR 76.5
- Immune-mediated adrenal insufficiency — n=170, PRR 61.8
- Immune-mediated hyperthyroidism — n=52, PRR 59.1
- Biliary tract infection — n=110, PRR 46.7
- Hepatic atrophy — n=70, PRR 39.2
- Immune-mediated hypothyroidism — n=167, PRR 39.1
✓ A hand-written Bradford Hill causality assessment exists for this drug: Paclitaxel ↔ Peripheral neuropathy.
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 Paclitaxel?
In FDA FAERS, the most frequently co-reported reaction terms for Paclitaxel are nausea, neutropenia, diarrhoea, dyspnoea, anaemia, 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 Paclitaxel have an FDA boxed warning?
Yes. The current FDA label carries a boxed warning: Paclitaxel should be administered under the supervision of a physician experienced in the use of cancer chemotherapeutic agents. Appropriate management of complications is possible only when adequate diagnostic and treatment facilities are readily available.
Do FAERS signals prove that Paclitaxel 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 0c12c77c-5fd4-48dc-a318-e96892233992, effective 20240624; matched on
openfda.generic_name.exact:"PACLITAXEL") - 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, 1,292 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
PACLITAXEL, 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.