Cisplatin side effects: what 77,661 FDA adverse event reports show
Who reports
77,661 reports · 97% serious · 14,919 with death outcome · 40% female
Used for
Cisplatin for injection is a platinum-based drug indicated for the treatment of: • Advanced testicular cancer ( 1.1 ) • Advanced ovarian cancer ( 1.2 ) • Advanced bladder cancer ( 1.3 ) 1.1 Advanced Testicular Cancer Cisplatin for injection is indicated for the treatment of advanced testicular cancer. 1.2 Advanced Ovarian Cancer Cisplatin for injection is indicated for the treatment of advanced ovarian cancer.
What it is
Cisplatin for injection, USP, a platinum-based drug for intravenous use, is a white to light yellow lyophilized powder.
Boxed warning
NEPHROTOXICITY, PERIPHERAL NEUROPATHY, NAUSEA AND VOMITING and MYELOSUPPRESSION. • Nephrotoxicity: cisplatin for injection can cause severe renal toxicity, including acute renal failure. Severe renal toxicities are dose-related and cumulative. Ensure adequate hydration and monitor renal function and electrolytes.
Causality screen of the 40 strongest signals
What the badges mean
- Labeled — boxed warning The term (or its clinical synonym) appears in the FDA boxed warning: causality is regulator-recognised and considered serious.
- 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). 1,226 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 |
|---|---|---|---|---|---|---|
| Ovarian germ cell teratoma | 36 | 217.2 139.8–337.3ROR 217.3 · calibrated p 1e-9 ✓ | 112.9 EB05 85.2 · IC025 +5.0 3/3 methods agree vs other Platinum-based Drugs: only this drug | Likely indication confounding shares a disease stem with the indications wording | serious n=36 · ♀ 100% (drug 40%) · 100% clinician | not reported in cached trials |
| Renal salt-wasting syndrome | 160 | 184.7 150.9–225.9ROR 185.0 · calibrated p 1e-9 ✓ | 107.9 EB05 94.6 · IC025 +6.1 3/3 methods agree vs other Platinum-based Drugs: PRR 3.5 (2.7–4.5) | Not in label — unassessed | serious n=158 · 96% clinician | not reported in cached trials |
| Aorto-oesophageal fistula | 31 | 130.6 85.0–200.8ROR 130.7 · calibrated p 6e-8 ✓ | 83.5 EB05 61.6 · IC025 +4.6 3/3 methods agree vs other Platinum-based Drugs: only this drug | Not in label — unassessed | serious n=31 · ♀ 0% (drug 40%) · 100% clinician | not reported in cached trials |
| Radiation mucositis | 43 | 96.7 68.2–137.1ROR 96.8 · calibrated p 3e-7 ✓ | 69.1 EB05 53.4 · IC025 +4.8 3/3 methods agree vs other Platinum-based Drugs: only this drug | Not in label — unassessed | serious n=42 · ♀ 0% (drug 40%) · 100% clinician | not reported in cached trials |
| Teratoma | 55 | 92.4 68.0–125.6ROR 92.5 · calibrated p 4e-7 ✓ | 67.3 EB05 53.6 · IC025 +5.0 3/3 methods agree vs other Platinum-based Drugs: only this drug | Not in label — unassessed | serious n=55 · ♀ 100% (drug 40%) · 100% clinician | not reported in cached trials |
| Oesophagobronchial fistula | 36 | 82.4 56.7–119.7ROR 82.4 · calibrated p 1e-6 ✓ | 61.2 EB05 46.2 · IC025 +4.5 3/3 methods agree vs other Platinum-based Drugs: only this drug | Not in label — unassessed | serious n=36 · ♀ 0% (drug 40%) · 100% clinician | not reported in cached trials |
| Refractory cancer | 50 | 80.9 59.0–111.1ROR 81.0 · calibrated p 1e-6 ✓ | 60.9 EB05 48.0 · IC025 +4.8 3/3 methods agree vs other Platinum-based Drugs: only this drug | Not in label — unassessed | serious n=50 · ♀ 100% (drug 40%) | not reported in cached trials |
| Oesophageal fistula | 70 | 76.1 58.4–99.3ROR 76.2 · calibrated p 1e-6 ✓ | 58.5 EB05 47.9 · IC025 +5.0 3/3 methods agree vs other Platinum-based Drugs: only this drug | Not in label — unassessed | serious n=70 · 100% clinician | NCT00148798: 1/548 (0.2%) on Cisplatin (serious AE) |
| Meningitis tuberculous | 115 | 69.2 56.4–85.0ROR 69.3 · calibrated p 2e-6 ✓ | 54.6 EB05 46.8 · IC025 +5.2 3/3 methods agree vs other Platinum-based Drugs: PRR 1.8 (1.4–2.4) | Not in label — unassessed | serious n=115 · ♀ 0% (drug 40%) | not reported in cached trials |
| Radiation oesophagitis | 77 | 68.6 53.4–88.1ROR 68.7 · calibrated p 2e-6 ✓ | 54.0 EB05 44.6 · IC025 +5.0 3/3 methods agree vs other Platinum-based Drugs: PRR 1.4 (1.0–1.8) | Not in label — unassessed | serious n=75 | not reported in cached trials |
| Diffuse large b-cell lymphoma refractory | 186 | 67.4 57.4–79.2ROR 67.6 · calibrated p 2e-6 ✓ | 53.7 EB05 47.5 · IC025 +5.3 3/3 methods agree vs other Platinum-based Drugs: PRR 1.7 (1.4–2.0) | Not in label — unassessed | serious n=185 | not reported in cached trials |
| Chemical peritonitis | 37 | 61.4 42.9–87.8ROR 61.4 · calibrated p 7e-6 ✓ | 48.9 EB05 37.0 · IC025 +4.4 3/3 methods agree vs other Platinum-based Drugs: only this drug | Not in label — unassessed | serious n=37 · 100% clinician | not reported in cached trials |
| Blood stem cell transplant failure | 40 | 61.4 43.5–86.6ROR 61.4 · calibrated p 7e-6 ✓ | 48.9 EB05 37.5 · IC025 +4.4 3/3 methods agree vs other Platinum-based Drugs: only this drug | Not in label — unassessed | serious n=40 · ♀ 0% (drug 40%) · 100% clinician | not reported in cached trials |
| Osteosarcoma | 67 | 56.8 43.6–74.0ROR 56.9 · calibrated p 8e-6 ✓ | 46.4 EB05 37.8 · IC025 +4.7 3/3 methods agree vs other Platinum-based Drugs: only this drug | Not in label — unassessed | serious n=63 · ♀ 0% (drug 40%) · 100% clinician | not reported in cached trials |
| Diffuse large b-cell lymphoma recurrent | 368 | 55.8 49.8–62.4ROR 56.0 · calibrated p 7e-6 ✓ | 46.1 EB05 42.3 · IC025 +5.3 3/3 methods agree vs other Platinum-based Drugs: PRR 1.4 (1.3–1.6) | Not in label — unassessed | serious n=366 | not reported in cached trials |
| Ototoxicity | 313 | 54.8 48.5–61.8ROR 55.0 · calibrated p 8e-6 ✓ | 45.5 EB05 41.4 · IC025 +5.2 3/3 methods agree vs other Platinum-based Drugs: PRR 2.5 (2.1–2.9) | Labeled — boxed warning exact term | serious n=308 · 92% clinician | not reported in cached trials |
| Osteoradionecrosis | 37 | 52.8 37.1–75.1ROR 52.8 · calibrated p 2e-5 ✓ | 43.3 EB05 32.8 · IC025 +4.3 3/3 methods agree vs other Platinum-based Drugs: only this drug | Not in label — unassessed | serious n=35 · ♀ 0% (drug 40%) · 100% clinician | not reported in cached trials |
| Malignant transformation | 73 | 52.4 40.7–67.3ROR 52.4 · calibrated p 1e-5 ✓ | 43.4 EB05 35.7 · IC025 +4.7 3/3 methods agree vs other Platinum-based Drugs: PRR 2.9 (2.0–4.1) | Not in label — unassessed | serious n=73 · 100% clinician | not reported in cached trials |
| Aortic thrombosis | 186 | 51.4 44.0–60.2ROR 51.5 · calibrated p 1e-5 ✓ | 43.1 EB05 38.1 · IC025 +5.0 3/3 methods agree vs other Platinum-based Drugs: PRR 4.1 (3.2–5.3) | Not in label — unassessed | serious n=183 · 95% clinician | not reported in cached trials |
| Urogenital fistula | 35 | 47.4 33.1–67.9ROR 47.4 · calibrated p 3e-5 ✓ | 39.6 EB05 29.7 · IC025 +4.1 3/3 methods agree vs other Platinum-based Drugs: PRR 1.4 (0.9–2.2) | Not in label — unassessed | serious n=36 · ♀ 100% (drug 40%) · 100% clinician | not reported in cached trials |
| Mantle cell lymphoma recurrent | 58 | 42.2 32.0–55.6ROR 42.2 · calibrated p 5e-5 ✓ | 36.1 EB05 29.0 · IC025 +4.4 3/3 methods agree vs other Platinum-based Drugs: only this drug | Not in label — unassessed | serious n=58 · 100% clinician | not reported in cached trials |
| Central hypothyroidism | 39 | 38.9 27.8–54.5ROR 38.9 · calibrated p 9e-5 ✓ | 33.6 EB05 25.6 · IC025 +4.1 3/3 methods agree vs other Platinum-based Drugs: only this drug | Not in label — unassessed | serious n=39 · ♀ 100% (drug 40%) · 92% clinician | not reported in cached trials |
| Anastomotic leak | 86 | 38.0 30.3–47.6ROR 38.0 · calibrated p 9e-5 ✓ | 33.1 EB05 27.7 · IC025 +4.5 3/3 methods agree vs other Platinum-based Drugs: PRR 1.4 (1.1–1.8) | Not in label — unassessed | serious n=86 · ♀ 0% (drug 40%) · 100% clinician | not reported in cached trials |
| B-cell lymphoma recurrent | 64 | 36.1 27.8–46.8ROR 36.1 · calibrated p 1e-4 ✓ | 31.6 EB05 25.6 · IC025 +4.3 3/3 methods agree vs other Platinum-based Drugs: only this drug | Not in label — unassessed | serious n=64 · ♀ 0% (drug 40%) | not reported in cached trials |
| Portal venous gas | 41 | 35.4 25.6–49.1ROR 35.5 · calibrated p 2e-4 ✓ | 31.0 EB05 23.8 · IC025 +4.0 3/3 methods agree vs other Platinum-based Drugs: PRR 2.1 (1.4–3.3) | Not in label — unassessed | serious n=41 · ♀ 0% (drug 40%) · 100% clinician | not reported in cached trials |
| Radiation skin injury | 126 | 32.8 27.3–39.5ROR 32.8 · calibrated p 2e-4 ✓ | 29.2 EB05 25.1 · IC025 +4.4 3/3 methods agree vs other Platinum-based Drugs: PRR 2.0 (1.5–2.5) | Not in label — unassessed | serious n=121 | not reported in cached trials |
| Thrombophlebitis migrans | 35 | 32.6 22.9–46.3ROR 32.6 · calibrated p 3e-4 ✓ | 28.7 EB05 21.6 · IC025 +3.8 3/3 methods agree vs other Platinum-based Drugs: only this drug | Not in label — unassessed | serious n=34 | not reported in cached trials |
| Cytomegalovirus oesophagitis | 36 | 29.4 20.8–41.5ROR 29.4 · calibrated p 4e-4 ✓ | 26.2 EB05 19.8 · IC025 +3.7 3/3 methods agree vs other Platinum-based Drugs: only this drug | Not in label — unassessed | serious n=36 · ♀ 0% (drug 40%) · 100% clinician | not reported in cached trials |
| Haematotoxicity | 878 | 28.2 26.3–30.2ROR 28.5 · calibrated p 3e-4 ✓ | 25.6 EB05 24.2 · IC025 +4.5 3/3 methods agree vs other Platinum-based Drugs: PRR 1.1 (1.0–1.2) | Not in label — unassessed | serious PRR 15.6 | not reported in cached trials |
| Immune-mediated renal disorder | 36 | 27.3 19.4–38.5ROR 27.3 · calibrated p 6e-4 ✓ | 24.6 EB05 18.5 · IC025 +3.7 3/3 methods agree vs other Platinum-based Drugs: PRR 1.1 (0.7–1.6) | Not in label — unassessed | serious n=36 · ♀ 0% (drug 40%) · 100% clinician | not reported in cached trials |
| Neutropenic sepsis | 633 | 26.1 24.1–28.3ROR 26.3 · calibrated p 5e-4 ✓ | 23.9 EB05 22.3 · IC025 +4.4 3/3 methods agree vs other Platinum-based Drugs: PRR 1.1 (1.0–1.2) | Not in label — unassessed | serious PRR 14.2 | NCT00148798: 9/548 (1.6%) on Cisplatin (serious AE) |
| Plasma cell leukaemia | 51 | 25.1 18.8–33.4ROR 25.1 · calibrated p 8e-4 ✓ | 22.8 EB05 18.0 · IC025 +3.8 3/3 methods agree vs other Platinum-based Drugs: only this drug | Not in label — unassessed | serious n=51 · 92% clinician | not reported in cached trials |
| Follicular lymphoma | 70 | 24.1 18.8–30.7ROR 24.1 · calibrated p 1e-3 ✓ | 22.0 EB05 18.0 · IC025 +3.9 3/3 methods agree vs other Platinum-based Drugs: PRR 1.5 (1.1–2.1) | Not in label — unassessed | serious n=69 · 93% clinician | not reported in cached trials |
| Oesophageal perforation | 67 | 23.6 18.4–30.3ROR 23.6 · calibrated p 0.001 ✓ | 21.6 EB05 17.6 · IC025 +3.8 3/3 methods agree vs other Platinum-based Drugs: only this drug | Not in label — unassessed | serious n=67 · ♀ 0% (drug 40%) · 100% clinician | not reported in cached trials |
| Recall phenomenon | 67 | 23.5 18.3–30.1ROR 23.5 · calibrated p 0.001 ✓ | 21.5 EB05 17.5 · IC025 +3.8 3/3 methods agree vs other Platinum-based Drugs: PRR 1.0 (0.8–1.4) | Not in label — unassessed | serious n=63 | not reported in cached trials |
| Reversible posterior leukoencephalopathy syndrome | 63 | 23.3 18.0–30.1ROR 23.3 · calibrated p 0.001 ✓ | 21.3 EB05 17.3 · IC025 +3.8 3/3 methods agree vs other Platinum-based Drugs: PRR 3.8 (2.5–5.8) | Labeled adverse reaction exact term | serious n=62 · ♀ 100% (drug 40%) · 100% clinician | not reported in cached trials |
| Gastrointestinal toxicity | 370 | 23.0 20.7–25.5ROR 23.1 · calibrated p 0.001 ✓ | 21.2 EB05 19.4 · IC025 +4.2 3/3 methods agree vs other Platinum-based Drugs: PRR 0.9 (0.8–1.0) | Labeled (related wording) related wording | serious n=369 · 92% clinician | not reported in cached trials |
| Myelosuppression | 2,662 | 22.9 22.0–23.8ROR 23.6 · calibrated p 9e-4 ✓ | 21.1 EB05 20.5 · IC025 +4.3 3/3 methods agree vs other Platinum-based Drugs: PRR 1.0 (0.9–1.0) | Labeled — boxed warning exact term | age-adj. PRR 15.9 · serious PRR 12.5 · 94% clinician | not reported in cached trials |
| Chloroma | 33 | 22.8 16.0–32.5ROR 22.8 · calibrated p 0.001 ✓ | 20.9 EB05 15.5 · IC025 +3.4 3/3 methods agree vs other Platinum-based Drugs: only this drug | Not in label — unassessed | serious n=33 · ♀ 0% (drug 40%) · 100% clinician | not reported in cached trials |
| Radiation pneumonitis | 163 | 22.2 18.9–26.0ROR 22.2 · calibrated p 0.001 ✓ | 20.5 EB05 18.0 · IC025 +4.0 3/3 methods agree vs other Platinum-based Drugs: PRR 1.0 (0.9–1.3) | Labeled (related wording) related wording | serious n=161 · 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 | 10,599 | 12.011.8–12.3 | signal |
| Thrombocytopenia | 5,543 | 6.96.8–7.1 | signal |
| Hyponatraemia | 1,737 | 5.95.7–6.2 | signal |
| Anaemia | 5,309 | 4.84.7–5.0 | signal |
| Interstitial lung disease | 1,554 | 4.44.2–4.7 | signal |
| Kidney injury | 6,122 | 3.73.6–3.7 | signal |
| Venous thromboembolism | 2,714 | 3.43.3–3.5 | signal |
| Serious infection | 6,719 | 2.42.3–2.4 | signal |
| Liver injury | 2,078 | 1.91.8–1.9 | raised |
| Opportunistic infection | 849 | 1.71.6–1.8 | raised |
| Gi bleeding | 991 | 1.51.4–1.6 | raised |
| Heart failure | 936 | 1.41.3–1.5 | raised |
| Arrhythmia / qt | 946 | 1.31.2–1.4 | raised |
| Osteonecrosis | 253 | 1.21.0–1.3 | raised |
| Stroke | 988 | 1.11.0–1.1 | raised |
| Severe cutaneous reaction | 288 | 1.00.9–1.2 | no difference |
Trial evidence (ClinicalTrials.gov)
✓ Trial adverse-event data found on ClinicalTrials.gov
Largest completed trials with posted results that list Cisplatin 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).
- NCT00148798 — Study of Cisplatin/Vinorelbine +/- Cetuximab as First-line Treatment of Advanced Non Small Cell Lung Cancer (F (N=1861, PHASE3; 308 AE terms posted; arms: Cetuximab Plus Chemotherapy; Chemotherapy Alone)
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 |
|---|---|---|---|---|---|---|
| Off label use (used outside approved label) | 5,885 | 1.8 1.8–1.9ROR 1.9 · calibrated p 0.891 | 1.8 EB05 1.8 · IC025 +0.8 vs other Platinum-based Drugs: PRR 0.9 (0.9–0.9) | Reporting / coding artifact | age-adj. PRR 1.7 · serious PRR 2.0 · 92% clinician | not reported in cached trials |
| Nausea | 5,437 | 1.9 1.8–1.9ROR 1.9 · calibrated p 0.906 | 1.9 EB05 1.8 · IC025 +0.9 vs other Platinum-based Drugs: PRR 0.9 (0.8–0.9) | Labeled — boxed warning exact term | age-adj. PRR 1.6 · serious PRR 2.0 | NCT00148798: 6/548 (1.1%) on Cisplatin (serious AE) |
| Neutropenia (low neutrophils (infection-fighting cells)) | 4,876 | 10.0 9.8–10.3ROR 10.7 · calibrated p 0.026 ✓ | 9.7 EB05 9.5 · IC025 +3.2 3/3 methods agree vs other Platinum-based Drugs: PRR 0.8 (0.8–0.9) | Labeled adverse reaction exact term | age-adj. PRR 7.7 · serious PRR 5.9 · 92% clinician | NCT00148798: 96/548 (17.5%) on Cisplatin (serious AE) |
| Disease progression | 4,659 | 11.1 10.8–11.4ROR 11.7 · calibrated p 0.018 ✓ | 10.7 EB05 10.4 · IC025 +3.4 3/3 methods agree vs other Platinum-based Drugs: PRR 0.9 (0.9–0.9) | Reporting / coding artifact | age-adj. PRR 8.9 · serious PRR 7.2 · 95% clinician | not reported in cached trials |
| Febrile neutropenia | 4,607 | 20.1 19.6–20.7ROR 21.3 · calibrated p 0.001 ✓ | 18.8 EB05 18.3 · IC025 +4.2 3/3 methods agree vs other Platinum-based Drugs: PRR 1.1 (1.1–1.1) | Labeled (related wording) related wording | age-adj. PRR 14.5 · serious PRR 11.1 · 93% clinician | NCT00148798: 96/548 (17.5%) on Cisplatin (serious AE) |
| Vomiting | 4,563 | 2.6 2.6–2.7ROR 2.7 · calibrated p 0.715 | 2.6 EB05 2.6 · IC025 +1.3 3/3 methods agree vs other Platinum-based Drugs: PRR 1.0 (0.9–1.0) | Labeled — boxed warning exact term | age-adj. PRR 2.0 · serious PRR 2.3 | NCT00148798: 16/548 (2.9%) on Cisplatin (serious AE) |
| Anaemia (low red blood cells) | 4,051 | 5.8 5.7–6.0ROR 6.1 · calibrated p 0.144 | 5.7 EB05 5.6 · IC025 +2.5 3/3 methods agree vs other Platinum-based Drugs: PRR 0.8 (0.8–0.9) | Labeled adverse reaction exact term | age-adj. PRR 4.9 · serious PRR 3.7 · 90% clinician | NCT00148798: 11/548 (2.0%) on Cisplatin (serious AE) |
| Thrombocytopenia (low platelets) | 3,787 | 9.5 9.2–9.8ROR 9.9 · calibrated p 0.033 ✓ | 9.2 EB05 8.9 · IC025 +3.1 3/3 methods agree vs other Platinum-based Drugs: PRR 0.8 (0.8–0.8) | Labeled (related wording) related wording | age-adj. PRR 7.6 · serious PRR 5.6 · 92% clinician | NCT00148798: 23/548 (4.2%) on Cisplatin |
| Diarrhoea (diarrhea) | 3,760 | 1.6 1.5–1.6ROR 1.6 · calibrated p 0.714 | 1.6 EB05 1.5 · IC025 +0.6 vs other Platinum-based Drugs: PRR 0.6 (0.6–0.6) | Labeled adverse reaction exact term | age-adj. PRR 1.3 · serious PRR 1.6 | NCT00148798: 8/548 (1.5%) on Cisplatin (serious AE) |
| Pyrexia (fever) | 3,398 | 2.7 2.6–2.8ROR 2.7 · calibrated p 0.716 | 2.6 EB05 2.6 · IC025 +1.3 3/3 methods agree vs other Platinum-based Drugs: PRR 0.9 (0.8–0.9) | Labeled (related wording) related wording | age-adj. PRR 2.2 · serious PRR 1.9 · 91% clinician | NCT00148798: 16/548 (2.9%) on Cisplatin (serious AE) |
| Drug ineffective (drug did not work) | 3,296 | 0.7 0.7–0.7ROR 0.7 · calibrated p 0.111 | 0.7 EB05 0.7 · IC025 -0.6 PRR-only: not supported by EBGM or IC vs other Platinum-based Drugs: PRR 1.0 (1.0–1.0) | Reporting / coding artifact | age-adj. PRR 0.9 · serious PRR 1.1 · 94% clinician | not reported in cached trials |
| Malignant neoplasm progression | 3,289 | 9.0 8.7–9.3ROR 9.3 · calibrated p 0.041 ✓ | 8.7 EB05 8.5 · IC025 +3.1 3/3 methods agree vs other Platinum-based Drugs: PRR 0.8 (0.8–0.9) | Reporting / coding artifact | age-adj. PRR 9.3 · serious PRR 5.3 | NCT00148798: 1/548 (0.2%) on Cisplatin (serious AE) |
| Death | 2,723 | 0.9 0.8–0.9ROR 0.8 · calibrated p 0.212 | 0.9 EB05 0.8 · IC025 -0.3 PRR-only: not supported by EBGM or IC vs other Platinum-based Drugs: PRR 0.8 (0.8–0.9) | Outcome field, not a reaction boxed warning mentions mortality | age-adj. PRR 0.7 · serious PRR 0.5 | NCT00148798: 2/548 (0.4%) on Cisplatin (serious AE) |
| Myelosuppression | 2,662 | 22.9 22.0–23.8ROR 23.6 · calibrated p 9e-4 ✓ | 21.1 EB05 20.5 · IC025 +4.3 3/3 methods agree vs other Platinum-based Drugs: PRR 1.0 (0.9–1.0) | Labeled — boxed warning exact term | age-adj. PRR 15.9 · serious PRR 12.5 · 94% clinician | not reported in cached trials |
| Fatigue (tiredness) | 2,505 | 0.9 0.8–0.9ROR 0.9 · calibrated p 0.222 | 0.9 EB05 0.8 · IC025 -0.3 PRR-only: not supported by EBGM or IC vs other Platinum-based Drugs: PRR 0.7 (0.6–0.7) | Labeled (related wording) related wording | age-adj. PRR 0.7 · serious PRR 0.9 | NCT00148798: 5/548 (0.9%) on Cisplatin (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.
- Renal salt-wasting syndrome — n=160, PRR 184.7
- Aorto-oesophageal fistula — n=31, PRR 130.6
- Radiation mucositis — n=43, PRR 96.7
- Teratoma — n=55, PRR 92.4
- Oesophagobronchial fistula — n=36, PRR 82.4
- Refractory cancer — n=50, PRR 80.9
- Oesophageal fistula — n=70, PRR 76.1 (also seen in trial arm)
- Meningitis tuberculous — n=115, PRR 69.2
- Radiation oesophagitis — n=77, PRR 68.6
- Diffuse large b-cell lymphoma refractory — n=186, PRR 67.4
✓ A hand-written Bradford Hill causality assessment exists for this drug: Cisplatin ↔ 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 Cisplatin?
In FDA FAERS, the most frequently co-reported reaction terms for Cisplatin are nausea, neutropenia, febrile neutropenia, vomiting, anaemia, thrombocytopenia. 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 Cisplatin have an FDA boxed warning?
Yes. The current FDA label carries a boxed warning: NEPHROTOXICITY, PERIPHERAL NEUROPATHY, NAUSEA AND VOMITING and MYELOSUPPRESSION. • Nephrotoxicity: cisplatin for injection can cause severe renal toxicity, including acute renal failure. Severe renal toxicities are dose-related and cumulative. Ensure adequate hydration and monitor renal function and electrolytes.
Do FAERS signals prove that Cisplatin 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 508496cb-3441-46b3-a4fe-e0d440e6adc6, effective 20260624; matched on
openfda.generic_name.exact:"CISPLATIN") - 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, 1,266 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
CISPLATIN, 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.