Paraplatin adverse event reports that FDA received

Name: Reaction terms in FDA adverse event reports that name Paraplatin
Creator: Reported Reactions
License: https://creativecommons.org/publicdomain/zero/1.0/

Name type: Product name as reported

What a report is

A report is not proof that the drug was the cause of the event.

FDA says:

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.
Source: openFDA, Drug Adverse Event Overview, section "Responsible use of the data". The site read the page on 2 Oct 2026. The data have the reports that FDA received through 30 Jun 2026.

FDA also says:

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 has not been scientifically or otherwise verified as to a cause and effect relationship and cannot be used to estimate the incidence of these events.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

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.
Source: openFDA, Response of the drug event API (meta.disclaimer). The site read the page on 2 Oct 2026.

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

Drug reports received through 30 Jun 2026. Device reports have a separate cutoff, 30 Sep 2026. Why a report count is not a rate.

Reports on file

From January 2004 to May 2026, FDA received 1,798 adverse event reports that name Paraplatin. The name is as reporters wrote it. In these reports the drug is a suspect or interacting product.

In the same period, 4,478 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 28 reports in the 12 months to June 2026 and 42 in the 12 months before. FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

Of the 1,332,454 drug reports that FDA received in the 12 months to June 2026, 28 (under 0.1%) name Paraplatin. Reports from consumers or other non-health professionals were 22.7% of the reports that name Paraplatin and 45.8% of all drug reports.

The number of people who use the product is not in the data. A count is not a rate. A count of reports is not a count of events or of patients, because one event can have more than one report.

There are many instances of duplicative reports and some reports do not contain all the necessary information.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

Suspect product

FDA records each drug in a report as suspect, concomitant or interacting. This page counts the reports in which Paraplatin is suspect or interacting. FDA says:

Any number of the drugs may be marked as suspect if thought to be responsible for one or more of the reactions, but that information is not validated.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Data version

openFDA FAERS release of 29 Oct 2026. Reports received through 30 Jun 2026.

Since the last update

FDA says:

Many factors can influence whether or not an event will be reported, such as the time a product has been marketed and publicity about an event.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The information in these reports cannot be used to estimate the incidence (occurrence rates) of the events reported.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

The latest update of the FDA data, recorded on 28 Oct 2026, changed no count of this page.

In April to June 2026, FDA received 7 reports that name Paraplatin.
In January to March 2026, FDA received 5.
In April to June 2025, FDA received 8.

April to June 2026 is the latest closed quarter in the data. A closed quarter is a quarter for which the FDA files have most of the reports.

All updates Feed of updates (RSS)

Reaction lookup

These are the reaction terms that the reports record, with the number of reports for each term. Type a term or a plain word to find its count.

What this list leaves out

The table lists the 116 reaction terms that 5 or more reports record. A term with fewer than 5 reports is not in the table.

The site keeps reaction terms for all 1,798 reports.

The site keeps a term for a year only if two or more reports of that year record it.

So a count in the table can be lower than the count of FDA.

Find a reaction term

The table shows the first 50 of 116 terms.

Reaction terms in the reports that name Paraplatin, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 1,798 reports
Alopeciahair loss	350	19.5%
Interstitial lung diseasescarring or inflammation of lung tissue	99	5.5%
Malignant neoplasm progression	86	4.8%
Pyrexiafever	64	3.6%
White blood cell count decreasedlow white cell count	60	3.3%
Deaththe patient died; cause not stated by this term	59	3.3%
Diarrhoealoose or frequent stools	59	3.3%
Nauseafeeling sick	57	3.2%
Pneumonialung infection	57	3.2%
Febrile neutropeniafever with low white blood cells	56	3.1%
Platelet count decreasedlow platelet count	46	2.6%
Dyspnoeashortness of breath	45	2.5%
Myelosuppression	40	2.2%
Vomitingbeing sick	40	2.2%
Hypersensitivityan allergic-type reaction	38	2.1%
Pancytopenialow counts of all blood cells	38	2.1%
Disseminated intravascular coagulation	35	1.9%
Neutropenialow neutrophils, a type of white blood cell	34	1.9%
Anaemialow red blood cells	33	1.8%
Neutrophil count decreased	31	1.7%
Off label useused for a purpose or in a way not on the label	29	1.6%
Thrombocytopenialow platelets	29	1.6%
Sepsisa severe body-wide response to infection	26	1.4%
Fatiguetiredness	25	1.4%
Rashskin rash	25	1.4%
Myelodysplastic syndrome	24	1.3%
Dizzinesslight-headedness or unsteadiness	22	1.2%
Hair colour changes	21	1.2%
Abdominal painstomach or belly pain	20	1.1%
Hair texture abnormal	20	1.1%
Pruritusitching	20	1.1%
Anaphylactic shocka severe allergic reaction with collapse	19	1.1%
Cerebral infarction	19	1.1%
Flushingsudden reddening or warmth of the skin	19	1.1%
Arthralgiajoint pain	18	1%
Dehydration	18	1%
Astheniaweakness or lack of energy	17	0.9%
Bone marrow failure	17	0.9%
Painpain, site not specified	17	0.9%
Decreased appetitereduced appetite	16	0.9%
Deep vein thrombosisa blood clot in a deep vein	16	0.9%
Haemoglobin decreasedlow haemoglobin	16	0.9%
Madarosis	16	0.9%
Acute myeloid leukaemia	15	0.8%
Renal failurekidney failure	15	0.8%
Alanine aminotransferase increasedraised liver enzyme (ALT)	14	0.8%
Aspartate aminotransferase increasedraised liver enzyme (AST)	14	0.8%
Hypotensionlow blood pressure	14	0.8%
Infectionan infection, type not specified	14	0.8%
Cardio-respiratory arrestthe heart and breathing stopped	13	0.7%

Download all 116 terms of Paraplatin (CSV)

The counts add to more than 1,798 reports, because one report can record more than one term. FDA says:

No individual drug is connected to any individual reaction. When a report lists multiple drugs and multiple reactions, there is no way to conclude from the data therein that a given drug is responsible for a given reaction.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The CSV file has the same rows and the same limits. Its last row is a note that says so.

MedDRA term

The person who codes a report selects the preferred term that agrees best with the description of the reporter. The words under a term are the plain meaning that this site gives.

Not the label

The FDA-approved label of a product lists its adverse reactions. See the official pages at the end of this page.

Outcomes by year

The table gives the outcomes that the reporters gave, in the terms of FDA.

Outcomes in the reports that name Paraplatin, by the year of the openFDA file that holds the report

The table continues to the right.

Year of the openFDA file	Reports	Serious	Death	Life-threatening	Hospitalization (initial or prolonged)	Disability or Permanent Damage	Other Serious (Important Medical Events)	Not serious
2004	213	163	44	32	63	12	64	50
2005	248	216	93	25	74	16	78	32
2006	132	113	51	20	41	6	33	19
2007	108	102	24	13	50	11	33	6
2008	109	104	27	25	53	10	37	5
2009	76	73	18	8	33	2	33	3
2010	58	57	19	8	23	4	30	1
2011	51	51	7	6	12	3	37	0
2012	24	24	5	3	11	0	12	0
2013	24	24	3	3	11	1	10	0
2014	27	27	9	5	12	3	13	0
2015	16	16	3	0	7	0	9	0
2016	16	15	3	2	9	1	10	1
2017	80	77	26	12	33	7	66	3
2018	77	65	0	0	11	1	57	12
2019	121	117	1	1	10	0	111	4
2020	27	26	0	4	9	4	17	1
2021	166	165	2	3	13	4	159	1
2022	48	45	3	5	16	3	42	3
2023	63	63	3	8	24	0	52	0
2024	57	47	7	6	23	1	33	10
2025	37	37	7	7	14	1	24	0
2026	20	20	5	1	5	0	13	0

An outcome in a report is not proof that the drug was the cause. The reporter gives the outcome, and FDA does not verify it. FDA says:

The information in these reports has not been scientifically or otherwise verified as to a cause and effect relationship and cannot be used to estimate the incidence of these events.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The six headings with the names of FDA are the outcome terms of FDA. A report can have more than one outcome. The columns Serious and Not serious are the two values of the openFDA field serious. For the value serious, openFDA gives this description:

The adverse event resulted in death, a life threatening condition, hospitalization, disability, congenital anomaly, or other serious condition
Source: openFDA, Drug adverse event fields (YAML reference). The site read the page on 2 Oct 2026.

The year is the year of the openFDA file that holds the latest version of the report. It is not always the year in which FDA first received the report. The chart of the next section uses the year of first receipt. The latest year is not complete.

Reports by year and month

Reports that name Paraplatin, by the year in which FDA received them

The column of 2026 has an outline, because the year is not complete. It has the reports that FDA received through June 2026 only.

Show the figures of the chart as a table

Reports that name Paraplatin, by the year in which FDA received them
Year	Reports
2004	147
2005	238
2006	200
2007	138
2008	122
2009	80
2010	58
2011	56
2012	28
2013	30
2014	21
2015	16
2016	13
2017	46
2018	121
2019	131
2020	33
2021	139
2022	44
2023	37
2024	52
2025	33
2026	12

Reports that name Paraplatin, by month, five years to June 2026

FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

Why a count moves

A count moves for many reasons. The guide gives FDA's words about them.

Patients and reporters

Age of the patient in the reports that name Paraplatin
Age	Reports	Share
Under 2	10	0.6%
2 to 11	28	1.6%
12 to 17	8	0.4%
18 to 44	174	9.7%
45 to 64	742	41.3%
65 to 74	421	23.4%
75 and over	121	6.7%
Age not given	294	16.4%

Sex of the patient in the reports that name Paraplatin
Sex	Reports	Share
Female	1,055	58.7%
Male	609	33.9%
Unknown or not given	134	7.5%

Type of reporter in the reports that name Paraplatin
Reporter	Reports	Share
Physician	534	29.7%
Pharmacist	52	2.9%
Other health professional	480	26.7%
Lawyer	305	17%
Consumer or non-health professional	408	22.7%
Not given	19	1.1%

Age and sex are as the report gives them. The reporter is the primary source in the report. 32.6% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Paraplatin record
Indication as recorded (MedDRA)	Reports	Share
Breast cancer	319	17.7%
Ovarian cancer	188	10.5%
Lung neoplasm malignant	173	9.6%
Non-small cell lung cancer	158	8.8%
Lung adenocarcinoma	47	2.6%
Uterine cancer	47	2.6%

The reporter fills in the indication, and the field is often empty. Each share is of all 1,798 reports.

Drugs in the same reports

Other drugs that the reports of Paraplatin name, in any role, in order of name
Drug	Reports that name the two
Benadryl	78
Decadron	197
Dexamethasone	134
Docetaxel	132
Docetaxel Accord	264
Herceptin	282
Paclitaxel	111
Perjeta	105
Taxol	635
Taxotere	134

The table has the 10 drug names that these reports name most. Two names in one report says only that the report recorded the two. It says nothing about the part of a product in the event.

FDA says:

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.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Importantly, the AEMS data by themselves are not an indicator of the safety profile of the drug or biologic.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

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These links are for navigation. No count selected them.

Official pages

DailyMed labels for ParaplatinThe labels (prescribing information) that have this name, at the National Library of Medicine.
MedWatch Online Voluntary Reporting FormThe online form of FDA for a voluntary report.
MedWatch: The FDA Safety Information and Adverse Event Reporting ProgramThe page of the FDA program that receives reports about drugs and devices.
FDA Adverse Event Monitoring System (AEMS) Public DashboardThe public dashboard of FDA for adverse event reports on drugs and biologics.

The site checked these addresses on 2 Oct 2026. The links open in a new tab.

Cite this page

Reported Reactions. Paraplatin: adverse event reports that FDA received. https://reportedreactions.com/drug/paraplatin/ Source: U.S. Food and Drug Administration, openFDA Drug Adverse Event (FAERS) files, release of 29 Oct 2026. Reports received through 30 Jun 2026.

Where the data come from

The counts come from the openFDA Drug Adverse Event (FAERS) bulk files, release of 29 Oct 2026. The files have the reports that FDA received through 30 Jun 2026. A drug name is the name on the report. The site matches it to a brand name or a generic name of the National Drug Code Directory of 2 Nov 2026. A class is the pharmacologic class (EPC) of the FDA label.

A report is in the count when it names Paraplatin as a suspect or interacting product. The 4,478 reports that name it only as a concomitant medicine are not in the count. The site does not publish a report narrative, a lot number, a detail of a patient or the identity of a reporter. The record of FDA is the authority. See how the site counts reports, the data sources and the corrections page.

Questions

Do these reports show that Paraplatin was responsible for the reactions?

No. FDA says:

For any given report, there is no certainty that a suspected drug caused the event.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

A reaction can relate to the condition that the drug treats, to other medicines, or to something else.

Is this the list of reactions on the label of Paraplatin?

No. It is a count of what people reported to FDA: 1,798 reports from January 2004 to May 2026. The FDA-approved label of a product lists its adverse reactions. The official pages at the end of this page link to the labels.

Who sent these reports?

Physician (29.7%), other health professional (26.7%) and consumer or non-health professional (22.7%). These are the types of reporter for the reports that name this drug.

If a manufacturer receives an adverse event report, it is normally required to send the report to FDA.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

How does a person report an adverse event?

FDA runs MedWatch, a program that takes voluntary reports from health professionals, patients and consumers. The guide on how to report has the links.

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