Ciflox adverse event reports that FDA received

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

Name type: Product name as reported
Also reported as: Ciflox /00697201/, Ciflox /00697202/

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 September 2021, FDA received 1,165 adverse event reports that name Ciflox. The name is as reporters wrote it. In these reports the drug is a suspect or interacting product.

In the same period, 609 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 0 reports in the 12 months to June 2026 and 0 in the 12 months before. FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

Reports from other health professionals were 51.9% of the reports that name Ciflox and 19.7% 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 Ciflox 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.

FDA received no report that names Ciflox in April to June 2026, in January to March 2026 or in April to June 2025.

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 118 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 1,114 of the 1,165 reports (95.6%).

The reports of the other years are not in the counts.

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 118 terms.

Reaction terms in the reports that name Ciflox, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 1,165 reports
Drug reaction with eosinophilia and systemic symptomsDRESS, a severe reaction with rash, fever and organ involvement	101	8.7%
Renal failure acute	81	7%
Pyrexiafever	78	6.7%
Thrombocytopenialow platelets	54	4.6%
Rash maculo-papulara rash of flat and raised spots	53	4.5%
Cholestasis	52	4.5%
Neutropenialow neutrophils, a type of white blood cell	49	4.2%
Acute kidney injurysudden loss of kidney function	48	4.1%
Toxic skin eruption	48	4.1%
Anaemialow red blood cells	43	3.7%
Agranulocytosis	42	3.6%
Confusional stateconfusion	41	3.5%
Eosinophilia	40	3.4%
Drug interactionan interaction between medicines	37	3.2%
International normalised ratio increasedblood clotting slower than intended (raised INR)	34	2.9%
Cytolytic hepatitis	31	2.7%
Rashskin rash	30	2.6%
Renal failurekidney failure	30	2.6%
Toxic epidermal necrolysisa severe skin reaction with peeling	30	2.6%
Leukopenialow white blood cells	27	2.3%
Vomitingbeing sick	27	2.3%
Drug rash with eosinophilia and systemic symptoms	26	2.2%
Dermatitis exfoliative	25	2.1%
Pancytopenialow counts of all blood cells	25	2.1%
General physical health deteriorationgeneral decline in health	23	2%
Diarrhoealoose or frequent stools	22	1.9%
Erythemaskin redness	22	1.9%
Pruritusitching	22	1.9%
Hepatocellular injury	21	1.8%
Skin exfoliationpeeling skin	20	1.7%
Dehydration	19	1.6%
Hepatitis	19	1.6%
Multi-organ failure	19	1.6%
Condition aggravatedthe condition being treated got worse	17	1.5%
Encephalopathy	17	1.5%
Face oedemaswelling of the face	17	1.5%
Purpura	17	1.5%
Clostridium difficile colitisa bowel infection with C. difficile	16	1.4%
Haematomaa collection of blood under the skin or in tissue	16	1.4%
Vascular purpura	16	1.4%
Acute generalised exanthematous pustulosis	15	1.3%
Hyperkalaemiahigh blood potassium	15	1.3%
Hypotensionlow blood pressure	15	1.3%
Deaththe patient died; cause not stated by this term	14	1.2%
Septic shockshock arising from infection	14	1.2%
Hyponatraemialow blood sodium	13	1.1%
Renal tubular necrosis	13	1.1%
Disorientation	12	1%
Lung disordera lung problem, type not specified	12	1%
Alanine aminotransferase increasedraised liver enzyme (ALT)	11	0.9%

Download all 118 terms of Ciflox (CSV)

The counts add to more than 1,165 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 Ciflox, 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	37	37	11	3	32	0	0	6	0
2005	37	37	11	5	30	0	0	2	0
2006	67	67	7	13	54	3	0	8	0
2007	71	70	16	14	56	1	0	4	1
2008	53	52	6	3	41	0	0	8	1
2009	104	104	11	20	88	2	0	22	0
2010	73	73	14	6	66	0	0	22	0
2011	27	27	1	2	23	0	0	4	0
2012	20	20	3	2	17	0	1	3	0
2013	147	147	16	20	124	2	0	34	0
2014	81	81	6	10	62	1	0	21	0
2015	78	78	5	5	65	3	0	17	0
2016	79	78	2	20	61	5	0	20	1
2017	34	34	2	3	27	1	0	15	0
2018	84	84	11	12	59	0	0	27	0
2019	71	71	13	22	42	1	0	24	0
2020	63	63	6	2	41	0	0	23	0
2021	39	39	8	5	29	4	0	6	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 Ciflox, by the year in which FDA received them

Show the figures of the chart as a table

Reports that name Ciflox, by the year in which FDA received them
Year	Reports
2004	32
2005	41
2006	72
2007	70
2008	54
2009	103
2010	68
2011	47
2012	32
2013	137
2014	83
2015	75
2016	80
2017	28
2018	83
2019	63
2020	62
2021	35

Reports that name Ciflox, 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 Ciflox
Age	Reports	Share
Under 2	3	0.3%
2 to 11	27	2.3%
12 to 17	23	2%
18 to 44	144	12.4%
45 to 64	315	27%
65 to 74	179	15.4%
75 and over	358	30.7%
Age not given	116	10%

Sex of the patient in the reports that name Ciflox
Sex	Reports	Share
Female	528	45.3%
Male	612	52.5%
Unknown or not given	25	2.1%

Type of reporter in the reports that name Ciflox
Reporter	Reports	Share
Physician	215	18.5%
Pharmacist	45	3.9%
Other health professional	605	51.9%
Lawyer	0	0%
Consumer or non-health professional	211	18.1%
Not given	89	7.6%

Age and sex are as the report gives them. The reporter is the primary source in the report. 0.9% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Ciflox record
Indication as recorded (MedDRA)	Reports	Share
Urinary tract infection	89	7.6%
Infection	38	3.3%
Lung disorder	27	2.3%
Osteitis	27	2.3%
Prostatitis	27	2.3%
Pneumonia	22	1.9%

The reporter fills in the indication, and the field is often empty. Each share is of all 1,165 reports.

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These links are for navigation. No count selected them.

Official pages

DailyMed labels for CifloxThe 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. Ciflox: adverse event reports that FDA received. https://reportedreactions.com/drug/ciflox/ 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 Ciflox as a suspect or interacting product. The 609 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 Ciflox 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 Ciflox?

No. It is a count of what people reported to FDA: 1,165 reports from January 2004 to September 2021. 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?

Other health professional (51.9%), physician (18.5%) and consumer or non-health professional (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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