Cubicin adverse event reports that FDA received

Name: Reaction terms in FDA adverse event reports that name Cubicin
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 June 2026, FDA received 6,326 adverse event reports that name Cubicin. The name is as reporters wrote it. In these reports the drug is a suspect or interacting product.

In the same period, 434 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 26 reports in the 12 months to June 2026 and 154 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, 26 (under 0.1%) name Cubicin. Reports from consumers or other non-health professionals were 14.1% of the reports that name Cubicin 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 Cubicin 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 Cubicin.
In January to March 2026, FDA received 6.
In April to June 2025, FDA received 18.

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 385 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 6,326 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 385 terms.

Reaction terms in the reports that name Cubicin, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 6,326 reports
Blood creatine phosphokinase increased	502	7.9%
Product use in unapproved indicationused for a purpose not on the label	478	7.6%
Off label useused for a purpose or in a way not on the label	421	6.7%
Eosinophilic pneumonia	411	6.5%
Deaththe patient died; cause not stated by this term	359	5.7%
Rhabdomyolysismuscle breakdown	257	4.1%
Pyrexiafever	238	3.8%
Drug ineffectivethe medicine did not work as expected	216	3.4%
Eosinophilia	201	3.2%
Rashskin rash	173	2.7%
Sepsisa severe body-wide response to infection	163	2.6%
Antimicrobial susceptibility test resistant	157	2.5%
Thrombocytopenialow platelets	151	2.4%
Renal failurekidney failure	149	2.4%
Pneumonialung infection	137	2.2%
Treatment failurethe treatment did not work	132	2.1%
Blood creatinine increasedraised creatinine, a kidney test	127	2%
Acute kidney injurysudden loss of kidney function	118	1.9%
Septic shockshock arising from infection	117	1.8%
Staphylococcal bacteraemia	117	1.8%
Dyspnoeashortness of breath	114	1.8%
Pathogen resistance	113	1.8%
Myalgiamuscle pain	109	1.7%
Renal failure acute	107	1.7%
Infectionan infection, type not specified	105	1.7%
Interstitial lung diseasescarring or inflammation of lung tissue	101	1.6%
Respiratory failurethe lungs could not supply enough oxygen	96	1.5%
Multi-organ failure	94	1.5%
Staphylococcal infection	92	1.5%
Endocarditis	91	1.4%
Drug interactionan interaction between medicines	89	1.4%
Drug resistance	89	1.4%
Drug ineffective for unapproved indication	87	1.4%
Eosinophilic pneumonia acute	86	1.4%
Overdosea dose above the recommended amount	86	1.4%
Renal impairmentreduced kidney function	79	1.2%
No adverse eventno adverse event was reported	77	1.2%
Condition aggravatedthe condition being treated got worse	75	1.2%
Pulmonary eosinophilia	75	1.2%
Hypotensionlow blood pressure	71	1.1%
Nauseafeeling sick	71	1.1%
Aspartate aminotransferase increasedraised liver enzyme (AST)	67	1.1%
Leukopenialow white blood cells	65	1%
Anaemialow red blood cells	64	1%
Chillschills or shivering	64	1%
International normalised ratio increasedblood clotting slower than intended (raised INR)	63	1%
Neutropenialow neutrophils, a type of white blood cell	62	1%
Osteomyelitis	60	0.9%
Pruritusitching	60	0.9%
Drug reaction with eosinophilia and systemic symptomsDRESS, a severe reaction with rash, fever and organ involvement	59	0.9%

Download all 385 terms of Cubicin (CSV)

The counts add to more than 6,326 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 Cubicin, 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	Congenital Anomaly/Birth Defect	Other Serious (Important Medical Events)	Not serious
2004	158	60	14	3	22	1	0	25	98
2005	225	74	19	0	22	2	0	36	151
2006	190	95	17	4	36	7	0	51	95
2007	154	148	73	4	47	2	0	44	6
2008	87	86	17	11	47	3	0	24	1
2009	135	132	43	7	55	7	0	46	3
2010	250	245	79	15	75	3	0	119	5
2011	360	352	96	23	106	9	0	217	8
2012	712	703	208	48	162	9	0	403	9
2013	646	625	204	41	244	6	0	263	21
2014	606	552	144	46	208	5	0	282	54
2015	271	221	53	24	111	4	0	115	50
2016	365	261	82	39	138	6	0	164	104
2017	245	182	32	22	96	3	0	113	63
2018	324	256	45	28	153	4	0	152	68
2019	324	221	35	21	106	13	0	150	103
2020	235	172	37	14	88	4	1	119	63
2021	293	221	57	16	116	8	0	151	72
2022	188	136	8	7	39	5	0	115	52
2023	235	123	19	7	76	1	0	103	112
2024	223	110	16	11	49	0	0	96	113
2025	73	65	9	7	26	2	0	51	8
2026	27	27	6	6	20	1	0	23	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 Cubicin, 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 Cubicin, by the year in which FDA received them
Year	Reports
2004	120
2005	188
2006	254
2007	155
2008	97
2009	126
2010	234
2011	388
2012	725
2013	686
2014	596
2015	288
2016	369
2017	290
2018	333
2019	338
2020	229
2021	273
2022	177
2023	210
2024	188
2025	49
2026	13

Reports that name Cubicin, 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 Cubicin
Age	Reports	Share
Under 2	30	0.5%
2 to 11	45	0.7%
12 to 17	45	0.7%
18 to 44	533	8.4%
45 to 64	1,303	20.6%
65 to 74	935	14.8%
75 and over	845	13.4%
Age not given	2,590	40.9%

Sex of the patient in the reports that name Cubicin
Sex	Reports	Share
Female	1,705	27%
Male	2,557	40.4%
Unknown or not given	2,064	32.6%

Type of reporter in the reports that name Cubicin
Reporter	Reports	Share
Physician	2,426	38.3%
Pharmacist	1,146	18.1%
Other health professional	1,408	22.3%
Lawyer	0	0%
Consumer or non-health professional	889	14.1%
Not given	457	7.2%

Age and sex are as the report gives them. The reporter is the primary source in the report. 54.4% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Cubicin record
Indication as recorded (MedDRA)	Reports	Share
Staphylococcal infection	553	8.7%
Endocarditis	320	5.1%
Osteomyelitis	307	4.9%
Staphylococcal bacteraemia	256	4%
Enterococcal infection	247	3.9%
Infection	190	3%

The reporter fills in the indication, and the field is often empty. Each share is of all 6,326 reports.

Drugs in the same reports

Other drugs that the reports of Cubicin name, in any role, in order of name
Drug	Reports that name the two
Acetaminophen	178
Aspirin	172
Furosemide	245
Gentamicin	292
Linezolid	336
Meropenem	399
Pantoprazole	173
Rifampicin	181
Rifampin	286
Vancomycin	1,011

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 CubicinThe 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. Cubicin: adverse event reports that FDA received. https://reportedreactions.com/drug/cubicin/ 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 Cubicin as a suspect or interacting product. The 434 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 Cubicin 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 Cubicin?

No. It is a count of what people reported to FDA: 6,326 reports from January 2004 to June 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 (38.3%), other health professional (22.3%) and pharmacist (18.1%). 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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