What the label lists and what reports show

Carboplatin side effects

Carboplatin's FDA label: “Other Events Pain and asthenia were the most frequently reported miscellaneous adverse effects; their relationship to the tumor and to anemia was likely.” FAERS holds 126,274 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is neutropenia (7,436 reports).

Generic listed
In shortage
Boxed warning

Check it at the source: the carboplatin FDA label on DailyMed (effective January 10, 2025, Eugia US LLC); the FDA FAERS public dashboard.

What does the patient leaflet say about side effects?

From the patient leaflet: What are the possible side effects of carboplatin?
Carboplatin may cause unwanted effects, particularly because carboplatin interferes with the growth of normal cells as well as cancer cells. For example, the occurrence of another cancer (secondary malignancy) has been reported in patients receiving cancer chemotherapy with multiple drugs. It is not always possible to tell whether such effects are caused by carboplatin, another drug you may be taking, or your illness. Because some of these effects may be serious, you will need close medical supervision during treatment with carboplatin. The most serious side effects of carboplatin are: bleeding and reduced blood cells, including reduced red blood cells (anemia) and platelets (needed for proper blood clotting), which may be severe enough to require blood transfusion. […]

Source: FDA drug label, Eugia US LLC, effective January 10, 2025 (SPL set f5fe9a20-47a5-45b9-ab06-c6158d9b6aca), via openFDA; the full label on DailyMed

What does the label list?

From the label: adverse reactions
Other Events Pain and asthenia were the most frequently reported miscellaneous adverse effects; their relationship to the tumor and to anemia was likely.

Table 3: Adverse Reactions (≥ 5%) in Patients with Advanced Ovarian Cancer - NCIC Study

This table is printed in the KYXATA label published by Avyxa Pharma, LLC of September 2, 2025; the label quoted above does not print one.

Adverse Reaction	Carboplatin in combination with cyclophosphamide (N=224) (%)*	Cisplatin in combination with cyclophosphamide (N=223) (%)*
Nausea and vomiting	93	98
Vomiting	84	97
Other GI adverse reactions	50	62
Mucositis	10	9
Alopecia	50	62
Asthenia	40	33
Pain	36	37
Cardiovascular	15	19
Infection	14	12
Hypersensitivity	12	9
Hemorrhage	10	4
Genitourinary	10	10
Respiratory	8	9
Central neurotoxicity	28	40
Peripheral neuropathies	16	42
Ototoxicity	13	33
Other sensory disorders	6	10

Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.

From the label: adverse reactions, continued
For a comparison of toxicities when carboplatin or cisplatin was given in combination with cyclophosphamide, see CLINICAL STUDIES , Use with Cyclophosphamide for Initial Treatment of Ovarian Cancer, Comparative Toxicity. ADVERSE EXPERIENCES IN PATIENTS WITH OVARIAN CANCER First Line Combination Therapy* Percent Second Line Single-Agent Therapy † Percent * Use with Cyclophosphamide for Initial Treatment of Ovarian Cancer: Data are based on the experience of 393 patients with ovarian cancer (regardless of baseline status) who received initial combination therapy with carboplatin and cyclophosphamide in two randomized controlled studies conducted by SWOG and NCIC (see CLINICAL STUDIES ). Combination with cyclophosphamide as well as duration of treatment may be responsible for the differences that can be noted in the adverse experience table. † Single Agent Use for the Secondary Treatment of Ovarian Cancer: Data are based on the experience of 553 patients with previously treated ovarian carcinoma (regardless of baseline status) who received single-agent carboplatin.

Source: FDA drug label, Eugia US LLC, effective January 10, 2025 (SPL set f5fe9a20-47a5-45b9-ab06-c6158d9b6aca), via openFDA; the full label on DailyMed

What do FAERS reports show?

126,274 reports list carboplatin among the medicines taken, each a report of something that happened, not proof the medicine caused it; 20,032 are coded as a death and 54,088 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 20 reactions below, 8 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.

Reports received each year

The 25 most reported reactions

Off Label Use (a use or a product term, not a reaction)8,564
Neutropenia (named in the label)7,436
Anaemia (named in the label)7,235
Nausea (named in the label)7,052
Febrile Neutropenia6,609
Diarrhoea (named in the label)6,243
Malignant Neoplasm Progression6,115
Disease Progression (a use or a product term, not a reaction)6,076
Thrombocytopenia (named in the label)5,937
Dyspnoea5,430
Vomiting (named in the label)5,150
Pyrexia4,848
Fatigue4,730
Drug Ineffective (a use or a product term, not a reaction)4,401
Death (an outcome recorded in the report)4,295
Asthenia (named in the label)3,895
Myelosuppression3,814
Pancytopenia3,716
Pneumonia3,380
Rash (named in the label)3,191
Decreased Appetite2,895
Neutrophil Count Decreased2,775
Sepsis2,751
Neuropathy Peripheral2,695
Product Use In Unapproved Indication (a use or a product term, not a reaction)2,673

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms

What next?

Carboplatin: the full record: label, generics, price, shortages, recalls
Report a side effect to the FDA: MedWatch
Side effects hub: the most reported medicines and reactions