Pharmacologic class (EPC) · 3 drug pages

Platinum-based drug: adverse event reports filed with FDA

230,969 reports list a drug in this class as a suspect or interacting product, 2004–2026.

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "There is no certainty that the reported event (adverse event or medication error) was actually due to the product. FDA does not require that a causal relationship between a product and event be proven, and reports do not always contain enough detail to properly evaluate an event." The information in these reports "cannot be used to estimate the incidence of these events."

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

230,969
reports across the class: 1.1% of all reports; 22,813
reports, 12 months to June 2026: 23,151 in the 12 months before; 97.4%
marked serious by the reporter: 57.4% across all reports; 3
drugs with a page: brand and generic names counted separately

Platinum-based drug is a pharmacologic class (an FDA Established Pharmacologic Class) with 3 drug pages on this site. Together those drugs are listed as a suspect or interacting product in 230,969 adverse event reports received by FDA, 1.1% of the database, from January 2004 to June 2026.

22,813 reports arrived in the 12 months to June 2026, close to the 23,151 of the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. 97.4% of the class's reports are marked serious, 15.4% record death among the outcomes and 43.1% record hospitalisation, as reported.

Across the class the reactions recorded most often are nausea (6.8%), off label use (6.6%) and neutropenia (6.5%). The class median share shown beside each term is the middle value across the member drugs; it is the comparison used on every drug page in this class.

The members table is ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Drugs in the class

Drug	Name type	Reports	Latest 12 months	Marked serious	Top term recorded
Carboplatin	generic	102,372	11,835	97.1%	Neutropenia
Cisplatin	generic	64,468	4,603	97.6%	Off label use
Oxaliplatin	generic	64,129	6,375	97.7%	Diarrhoea

Ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Reports by month, five years

FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

Reactions recorded across the class

share of class reports recording the termmedian drug in the class

Nauseafeeling sick6.8%15,599
Off label useused for a purpose or in a way not on the label6.6%15,246
Neutropenialow neutrophils, a type of white blood cell6.5%15,027
Diarrhoealoose or frequent stools6.3%14,534
Disease progressionthe disease advanced5.6%12,954
Vomitingbeing sick5.4%12,535
Anaemialow red blood cells5.3%12,153
Thrombocytopenialow platelets5.2%12,112
Febrile neutropeniafever with low white blood cells5.2%11,910
Pyrexiafever4.1%9,478
Malignant neoplasm progression3.8%8,830
Dyspnoeashortness of breath3.8%8,782
Drug ineffectivethe medicine did not work as expected3.6%8,367
Fatiguetiredness3.5%8,188
Neuropathy peripheralnerve damage in hands or feet3.1%7,242
Myelosuppression3.1%7,221
Astheniaweakness or lack of energy3.1%7,084
Pneumonialung infection2.5%5,813
Pancytopenialow counts of all blood cells2.5%5,763
Decreased appetitereduced appetite2.5%5,695
Deaththe patient died; cause not stated by this term2.5%5,664
Dehydrationdehydration2.4%5,606
Sepsisa severe body-wide response to infection2.4%5,434
Acute kidney injurysudden loss of kidney function2.3%5,252
Abdominal painstomach or belly pain2.1%4,897

Solid bar: share of all class reports. Hollow bar: the median share across the 3 member drugs, the reference used on each member's page. One report can record several terms.

Outcomes, patients and reporters

Outcomes recorded

Death15.4%35,639

Life-threatening8.5%19,579

Hospitalisation (initial or prolonged)43.1%99,564

Disability1.5%3,530

Congenital anomaly0.1%228

Other serious60.6%139,990

Not serious2.6%5,990

Patient age

Under 20.8%1,773

2 to 111.9%4,447

12 to 171%2,248

18 to 448.7%20,031

45 to 6431.2%72,149

65 to 7422.1%51,000

75 and over8.6%19,923

Age not given25.7%59,398

Who reported

Physician41.8%96,551

Pharmacist6.9%15,998

Other health professional40%92,469

Lawyer0.1%252

Consumer or non-health professional6.7%15,457

Not given4.4%10,242

Grey bar: all 20,646,523 reports in the database. Outcome flags are as the reporter set them and are not verified by FDA.

Questions about Platinum-based drug reports

Which drugs are in the Platinum-based drug class on this site?

Carboplatin, Cisplatin and Oxaliplatin. Class membership comes from the pharmacologic class (EPC) on the drug's FDA label.

How many reports does the class have?

230,969 reports through June 2026, 22,813 of them in the latest 12 months. A report listing two drugs of the class counts once for each.

What reactions are recorded most often?

nausea (6.8%), off label use (6.6%), neutropenia (6.5%), diarrhoea (6.3%) and disease progression (5.6%).

Can the members table be used to rank the drugs?

No. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic." Drugs differ in how many people take them, in the conditions they treat, in time on the market and in how diligently reports are collected.

How do I report an adverse event?

Through FDA MedWatch (Form FDA 3500, or 1-800-FDA-1088) or to the manufacturer. See the guide on how to report.

Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A class is the Established Pharmacologic Class most often attached to a drug's reports by openFDA's label harmonisation, or from the NDC Directory where reports carry none. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.

Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.