Drug · FAERS side-effect profile with label screen
Carboplatin side effects: what 126,268 FDA adverse event reports show
Who reports
126,268 reports · 95% serious · 20,032 with death outcome · 59% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Initial Treatment of Advanced Ovarian Carcinoma Carboplatin injection is indicated for the initial treatment of advanced ovarian carcinoma in established combination with other approved chemotherapeutic agents. One established combination regimen consists of carboplatin and cyclophosphamide.
FDA label, Indications and Usage
What it is
DESCRIPTION Carboplatin injection is supplied as a sterile, pyrogen-free, 10 mg/mL aqueous solution of carboplatin, USP. It is available in multiuse vials containing 50 mg/5 mL, 150 mg/15 mL, and 450 mg/45 mL or 600 mg/60 mL of carboplatin, USP. Inactive ingredients include water for injection, USP.
FDA label, Description section
Boxed warning
Carboplatin injection should be administered under the supervision of a qualified physician experienced in the use of cancer chemotherapeutic agents. Appropriate management of therapy and complications is possible only when adequate treatment facilities are readily available.
FDA label
How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation.
Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)?
That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.
Causality screen of the 40 strongest signals
Labeled adverse reaction 1Labeled (related wording) 1Likely indication confounding 1Not in label — unassessed 37
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 flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 1,290 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
Show:
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Cervix carcinoma recurrent | 55 | 79.3 57.4–109.4ROR 79.3 · χ² 2,806 / p <1e-300 | 52.7 EB05 42.0 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious n=54 · ♀ 100% (drug 59%) · 100% clinician | no trial arm names this drug |
| Immune-mediated hyperthyroidism | 77 | 78.9 60.1–103.5ROR 78.9 · χ² 3,936 / p <1e-300 | 52.8 EB05 43.6 · IC025 +4.9 3/3 methods agree | Not in label — unassessed | serious n=77 · 100% clinician | no trial arm names this drug |
| Radiation oesophagitis | 113 | 70.2 56.3–87.6ROR 70.3 · χ² 5,341 / p <1e-300 | 49.0 EB05 41.9 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious n=110 · ♀ 36% (drug 59%) · 100% clinician | no trial arm names this drug |
| Immune-mediated adrenal insufficiency | 207 | 62.7 53.4–73.6ROR 62.8 · χ² 9,027 / p <1e-300 | 45.4 EB05 40.4 · IC025 +5.1 3/3 methods agree | Not in label — unassessed | serious n=207 · 100% clinician | no trial arm names this drug |
| Pseudocellulitis | 53 | 55.3 40.5–75.6ROR 55.4 · χ² 2,070 / p <1e-300 | 41.0 EB05 32.5 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious n=52 · ♀ 0% (drug 59%) · 100% clinician | no trial arm names this drug |
| Immune-mediated hypothyroidism | 265 | 54.2 47.2–62.3ROR 54.3 · χ² 10,346 / p <1e-300 | 40.8 EB05 36.9 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious n=265 · 95% clinician | no trial arm names this drug |
| Immune-mediated dermatitis | 223 | 51.8 44.6–60.2ROR 51.9 · χ² 8,392 / p <1e-300 | 39.4 EB05 35.3 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious n=222 · 95% clinician | no trial arm names this drug |
| Renal salt-wasting syndrome | 92 | 50.3 39.8–63.5ROR 50.3 · χ² 3,358 / p <1e-300 | 38.4 EB05 32.2 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious n=92 · 100% clinician | no trial arm names this drug |
| Immune-mediated nephritis | 105 | 50.0 40.2–62.2ROR 50.0 · χ² 3,820 / p <1e-300 | 38.2 EB05 32.5 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious n=105 · 100% clinician | no trial arm names this drug |
| Meningitis tuberculous | 125 | 47.2 38.7–57.6ROR 47.3 · χ² 4,349 / p <1e-300 | 36.7 EB05 31.6 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious n=125 · ♀ 0% (drug 59%) | no trial arm names this drug |
| Urogenital fistula | 50 | 45.0 32.9–61.5ROR 45.0 · χ² 1,651 / p <1e-300 | 35.0 EB05 27.6 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious n=50 · ♀ 100% (drug 59%) · 100% clinician | no trial arm names this drug |
| Immune-mediated hypophysitis | 91 | 44.6 35.4–56.3ROR 44.7 · χ² 3,013 / p <1e-300 | 35.0 EB05 29.4 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious n=91 · 100% clinician | no trial arm names this drug |
| Immune-mediated lung disease | 350 | 41.5 36.9–46.6ROR 41.6 · χ² 10,983 / p <1e-300 | 33.2 EB05 30.4 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious n=350 · 97% clinician | no trial arm names this drug |
| Lacrimal structure injury | 70 | 37.6 29.0–48.8ROR 37.6 · χ² 1,998 / p <1e-300 | 30.5 EB05 25.0 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | ♀ 100% (drug 59%) | no trial arm names this drug |
| Immune-mediated hepatic disorder | 350 | 37.1 33.0–41.6ROR 37.2 · χ² 9,982 / p <1e-300 | 30.3 EB05 27.8 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious n=349 · 94% clinician | no trial arm names this drug |
| Immune-mediated hepatitis | 346 | 35.4 31.5–39.8ROR 35.5 · χ² 9,473 / p <1e-300 | 29.2 EB05 26.7 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious n=342 · 95% clinician | no trial arm names this drug |
| Congenital aplasia | 50 | 34.5 25.4–46.8ROR 34.5 · χ² 1,315 / p 4e-288 | 28.4 EB05 22.4 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious n=50 · ♀ 0% (drug 59%) · 100% clinician | no trial arm names this drug |
| Immune-mediated renal disorder | 67 | 34.2 26.3–44.5ROR 34.2 · χ² 1,758 / p <1e-300 | 28.2 EB05 23.0 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious n=67 · 100% clinician | no trial arm names this drug |
| Immune-mediated pancreatitis | 63 | 34.1 26.0–44.7ROR 34.1 · χ² 1,646 / p <1e-300 | 28.1 EB05 22.8 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious n=63 · ♀ 100% (drug 59%) · 100% clinician | no trial arm names this drug |
| Immune-mediated thyroiditis | 79 | 33.5 26.3–42.7ROR 33.5 · χ² 2,039 / p <1e-300 | 27.8 EB05 23.0 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious n=79 · 100% clinician | no trial arm names this drug |
| Immune-mediated arthritis | 60 | 32.0 24.3–42.3ROR 32.1 · χ² 1,482 / p <1e-300 | 26.7 EB05 21.5 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious n=60 · 100% clinician | no trial arm names this drug |
| Immune-mediated enterocolitis | 534 | 29.5 26.9–32.4ROR 29.6 · χ² 12,435 / p <1e-300 | 25.1 EB05 23.4 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious n=533 · 94% clinician | no trial arm names this drug |
| Glucocorticoid deficiency | 62 | 29.0 22.1–38.0ROR 29.0 · χ² 1,400 / p <1e-300 | 24.6 EB05 19.9 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious n=62 · ♀ 100% (drug 59%) · 100% clinician | no trial arm names this drug |
| Radiation pneumonitis | 311 | 28.1 24.9–31.6ROR 28.1 · χ² 6,901 / p <1e-300 | 24.1 EB05 21.9 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious n=309 · ♀ 35% (drug 59%) · 90% clinician | no trial arm names this drug |
| Diffuse large b-cell lymphoma refractory | 133 | 27.6 23.0–33.2ROR 27.6 · χ² 2,892 / p <1e-300 | 23.7 EB05 20.5 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious n=133 · ♀ 34% (drug 59%) | no trial arm names this drug |
| Immune-mediated encephalitis | 70 | 27.2 21.1–35.0ROR 27.2 · χ² 1,492 / p <1e-300 | 23.3 EB05 19.1 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious n=70 · 100% clinician | no trial arm names this drug |
| Non-small cell lung cancer | 665 | 27.1 24.9–29.4ROR 27.2 · χ² 14,291 / p <1e-300 | 23.3 EB05 21.9 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious n=663 · 95% clinician | no trial arm names this drug |
| Adrenocorticotropic hormone deficiency | 122 | 26.9 22.2–32.6ROR 26.9 · χ² 2,588 / p <1e-300 | 23.1 EB05 19.9 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious n=122 · 94% clinician | no trial arm names this drug |
| Egfr gene mutation | 52 | 26.4 19.7–35.4ROR 26.4 · χ² 1,071 / p 3e-235 | 22.7 EB05 18.0 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious n=52 · ♀ 100% (drug 59%) · 100% clinician | no trial arm names this drug |
| Ototoxicity | 255 | 26.4 23.1–30.1ROR 26.4 · χ² 5,335 / p <1e-300 | 22.8 EB05 20.5 · IC025 +4.2 3/3 methods agree | Labeled adverse reaction exact term | serious n=255 | no trial arm names this drug |
| Non-small cell lung cancer metastatic | 115 | 25.5 21.0–31.1ROR 25.5 · χ² 2,321 / p <1e-300 | 22.1 EB05 18.9 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious n=115 · 90% clinician | no trial arm names this drug |
| Neutropenic sepsis | 932 | 24.8 23.1–26.5ROR 24.9 · χ² 18,430 / p <1e-300 | 21.6 EB05 20.5 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious PRR 13.0 · 93% clinician | no trial arm names this drug |
| Diffuse large b-cell lymphoma recurrent | 276 | 24.4 21.5–27.7ROR 24.4 · χ² 5,362 / p <1e-300 | 21.3 EB05 19.3 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious n=275 | no trial arm names this drug |
| Ovarian cancer recurrent | 197 | 23.2 20.0–26.9ROR 23.2 · χ² 3,644 / p <1e-300 | 20.4 EB05 18.1 · IC025 +4.0 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=192 · ♀ 100% (drug 59%) · 94% clinician | no trial arm names this drug |
| Immune-mediated myocarditis | 186 | 22.7 19.5–26.5ROR 22.8 · χ² 3,371 / p <1e-300 | 20.0 EB05 17.7 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious n=186 · 96% clinician | no trial arm names this drug |
| Febrile bone marrow aplasia | 485 | 21.7 19.7–23.8ROR 21.7 · χ² 8,419 / p <1e-300 | 19.2 EB05 17.8 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious n=485 · 92% clinician | no trial arm names this drug |
| Ovarian cancer metastatic | 96 | 21.3 17.2–26.3ROR 21.3 · χ² 1,625 / p <1e-300 | 18.9 EB05 15.9 · IC025 +3.8 3/3 methods agree | Labeled (related wording) related wording | serious n=95 · ♀ 100% (drug 59%) | no trial arm names this drug |
| Malignant transformation | 51 | 21.2 15.8–28.4ROR 21.2 · χ² 850 / p 3e-187 | 18.7 EB05 14.8 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious n=51 · ♀ 100% (drug 59%) · 100% clinician | no trial arm names this drug |
| Myelosuppression | 3,814 | 20.9 20.2–21.6ROR 21.5 · χ² 64,053 / p <1e-300 | 18.6 EB05 18.1 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious PRR 11.2 · 97% clinician | no trial arm names this drug |
| Haematotoxicity | 1,028 | 20.6 19.3–22.0ROR 20.8 · χ² 17,020 / p <1e-300 | 18.4 EB05 17.5 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious PRR 11.4 · 95% clinician | no trial arm names this drug |
Trial evidence (ClinicalTrials.gov)
ClinicalTrials.gov returned results-bearing trials mentioning Carboplatin only as a background or rescue medication (NCT01358877, NCT00011986); no trial listing it as the tested intervention was cached, so no trial cross-check is shown.
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) | 8,564 | 1.6 1.6–1.7ROR 1.7 · χ² 2,237 / p <1e-300 | 1.6 EB05 1.6 · IC025 +0.7 | Reporting / coding artifact | serious PRR 1.7 | no trial arm names this drug |
| Neutropenia (low neutrophils (infection-fighting cells)) | 7,435 | 9.6 9.4–9.8ROR 10.1 · χ² 54,371 / p <1e-300 | 9.1 EB05 8.9 · IC025 +3.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.6 | no trial arm names this drug |
| Anaemia (low red blood cells) | 7,235 | 6.5 6.4–6.7ROR 6.8 · χ² 32,715 / p <1e-300 | 6.3 EB05 6.2 · IC025 +2.6 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 4.1 | no trial arm names this drug |
| Nausea | 7,052 | 1.5 1.5–1.5ROR 1.5 · χ² 1,165 / p 1e-255 | 1.5 EB05 1.5 · IC025 +0.5 | Labeled adverse reaction exact term | serious PRR 1.6 | no trial arm names this drug |
| Febrile neutropenia | 6,610 | 18.3 17.9–18.8ROR 19.3 · χ² 97,623 / p <1e-300 | 16.6 EB05 16.2 · IC025 +4.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 10.0 · 91% clinician | no trial arm names this drug |
| Diarrhoea (diarrhea) | 6,243 | 1.6 1.6–1.7ROR 1.7 · χ² 1,504 / p <1e-300 | 1.6 EB05 1.6 · IC025 +0.6 | Labeled adverse reaction exact term | serious PRR 1.7 | no trial arm names this drug |
| Malignant neoplasm progression | 6,115 | 10.5 10.3–10.8ROR 11.0 · χ² 49,877 / p <1e-300 | 10.0 EB05 9.8 · IC025 +3.3 3/3 methods agree | Reporting / coding artifact | serious PRR 6.1 | no trial arm names this drug |
| Disease progression | 6,076 | 9.0 8.7–9.2ROR 9.4 · χ² 41,015 / p <1e-300 | 8.6 EB05 8.4 · IC025 +3.1 3/3 methods agree | Reporting / coding artifact | serious PRR 5.8 · 95% clinician | no trial arm names this drug |
| Thrombocytopenia (low platelets) | 5,938 | 9.3 9.1–9.5ROR 9.7 · χ² 41,772 / p <1e-300 | 8.8 EB05 8.7 · IC025 +3.1 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 5.5 | no trial arm names this drug |
| Dyspnoea (shortness of breath) | 5,430 | 1.6 1.6–1.6ROR 1.6 · χ² 1,243 / p 1e-272 | 1.6 EB05 1.6 · IC025 +0.6 | Not in label — unassessed | serious PRR 1.3 | no trial arm names this drug |
| Vomiting | 5,151 | 1.8 1.8–1.9ROR 1.9 · χ² 1,974 / p <1e-300 | 1.8 EB05 1.8 · IC025 +0.8 | Labeled — boxed warning exact term | serious PRR 1.6 | no trial arm names this drug |
| Pyrexia (fever) | 4,849 | 2.3 2.3–2.4ROR 2.4 · χ² 3,748 / p <1e-300 | 2.3 EB05 2.3 · IC025 +1.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 1.7 · 91% clinician | no trial arm names this drug |
| Fatigue (tiredness) | 4,731 | 1.0 1.0–1.0ROR 1.0 · χ² 1 / p 0.216 | 1.0 EB05 1.0 · IC025 -0.0 PRR-only: not supported by EBGM or IC | Labeled (related wording) related wording | serious PRR 1.1 | no trial arm names this drug |
| Drug ineffective (drug did not work) | 4,399 | 0.6 0.5–0.6ROR 0.5 · χ² 1,686 / p <1e-300 | 0.6 EB05 0.5 · IC025 -0.9 PRR-only: not supported by EBGM or IC | Reporting / coding artifact | serious PRR 0.9 · 93% clinician | no trial arm names this drug |
| Death | 4,294 | 0.8 0.8–0.9ROR 0.8 · χ² 161 / p 4e-37 | 0.8 EB05 0.8 · IC025 -0.3 PRR-only: not supported by EBGM or IC | Outcome field, not a reaction | serious PRR 0.5 | no trial arm names this drug |
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.
- Cervix carcinoma recurrent — n=55, PRR 79.3
- Immune-mediated hyperthyroidism — n=77, PRR 78.9
- Radiation oesophagitis — n=113, PRR 70.2
- Immune-mediated adrenal insufficiency — n=207, PRR 62.7
- Pseudocellulitis — n=53, PRR 55.3
- Immune-mediated hypothyroidism — n=265, PRR 54.2
- Immune-mediated dermatitis — n=223, PRR 51.8
- Renal salt-wasting syndrome — n=92, PRR 50.3
- Immune-mediated nephritis — n=105, PRR 50.0
- Meningitis tuberculous — n=125, PRR 47.2
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 Carboplatin?
In FDA FAERS, the most frequently co-reported reaction terms for Carboplatin are neutropenia, anaemia, nausea, febrile neutropenia, diarrhoea, 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 Carboplatin have an FDA boxed warning?
Yes. The current FDA label carries a boxed warning: Carboplatin injection should be administered under the supervision of a qualified physician experienced in the use of cancer chemotherapeutic agents. Appropriate management of therapy and complications is possible only when adequate treatment facilities are readily available.
Do FAERS signals prove that Carboplatin 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 1c275825-0275-4c73-b650-e4c1519f13b8, effective 20240107; matched on
openfda.generic_name.exact:"CARBOPLATIN" AND openfda.product_type:"HUMAN PRESCRIPTION DRUG") - 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, 1,330 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
CARBOPLATIN, results-bearing studies sorted by enrollment)
Page generated 2026-10-08. 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.