Ciprofloxacin adverse event reports that FDA received

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

Name type: Generic name
Class: Fluoroquinolone antibacterial
Also reported as: Ciprofloxacin 500mg, Ciprofloxacin Extended Release, Ciprofloxacin Er

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.

Reports on file

From January 2004 to June 2026, FDA received 39,570 adverse event reports that name Ciprofloxacin. In these reports the drug is a suspect or interacting product.

In the same period, 32,516 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 2,405 reports in the 12 months to June 2026 and 2,663 in the 12 months before. FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

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 Ciprofloxacin 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 1 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.

No update is on record for this page. The record starts when FDA adds the reports of July to September 2026.

In April to June 2026, FDA received 555 reports that name Ciprofloxacin.
In January to March 2026, FDA received 521.
In April to June 2025, FDA received 632.

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 2,419 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 39,298 of the 39,570 reports (99.3%).

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 2,419 terms.

Reaction terms in the reports that name Ciprofloxacin, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 39,570 reports
Drug hypersensitivityan allergic-type reaction (the term names a medicine)	3,167	8%
Arthralgiajoint pain	3,164	8%
Drug ineffectivethe medicine did not work as expected	2,715	6.9%
Fatiguetiredness	2,517	6.4%
Painpain, site not specified	2,502	6.3%
Drug interactionan interaction between medicines	2,363	6%
Diarrhoealoose or frequent stools	2,278	5.8%
Nauseafeeling sick	2,268	5.7%
Pain in extremitypain in an arm or leg	2,057	5.2%
Dyspnoeashortness of breath	2,019	5.1%
Myalgiamuscle pain	1,998	5%
Vomitingbeing sick	1,875	4.7%
Headachehead pain	1,863	4.7%
Anxiety	1,838	4.6%
Paraesthesiatingling or pins and needles	1,756	4.4%
Rashskin rash	1,734	4.4%
Tendonitisinflammation of a tendon	1,729	4.4%
Malaisegeneral feeling of being unwell	1,706	4.3%
Tendon pain	1,649	4.2%
Dizzinesslight-headedness or unsteadiness	1,644	4.2%
Off label useused for a purpose or in a way not on the label	1,489	3.8%
Pyrexiafever	1,485	3.8%
Astheniaweakness or lack of energy	1,476	3.7%
Insomniadifficulty sleeping	1,345	3.4%
Neuropathy peripheralnerve damage in hands or feet	1,296	3.3%
Acute kidney injurysudden loss of kidney function	1,292	3.3%
Depressionlow mood	1,264	3.2%
Condition aggravatedthe condition being treated got worse	1,263	3.2%
Hypoaesthesianumbness	1,215	3.1%
Muscular weaknessmuscle weakness	1,211	3.1%
Pruritusitching	1,187	3%
Gait disturbancedifficulty walking	1,171	3%
Pneumonialung infection	1,152	2.9%
Abdominal painstomach or belly pain	1,147	2.9%
Back pain	937	2.4%
Tinnitusringing in the ears	929	2.3%
Weight decreasedweight loss	910	2.3%
Palpitationsawareness of the heartbeat	907	2.3%
Muscle spasmsmuscle cramps	902	2.3%
Cough	886	2.2%
Tendon rupturea torn tendon	879	2.2%
Confusional stateconfusion	877	2.2%
Chest pain	830	2.1%
Abdominal pain upperupper stomach pain	818	2.1%
Tendon disorder	815	2.1%
Hypersensitivityan allergic-type reaction	813	2.1%
Burning sensationa burning feeling	803	2%
Tremorshaking	797	2%
Erythemaskin redness	791	2%
Feeling abnormalfeeling odd or not right	741	1.9%

Download all 2,419 terms of Ciprofloxacin (CSV)

The counts add to more than 39,570 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.

Same ingredient, other names

Reporters write a brand name or a generic name. Each name has its own page and its own count.

Names of Ciprofloxacin with a page, in the order generic names, brand names, names as reported
Name	Name type	Reports
Ciprofloxacin (this page)	Generic name	39,570
Ciprofloxacin hydrochloride	Generic name	3,653
Cipro	Brand name	9,791

Sum of the separately reported names: 53,014. A report that names two of these names is in the sum two times. The sum is not the number of reports for the ingredient.

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.

Outcomes by year

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

Outcomes in the reports that name Ciprofloxacin, 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	287	279	50	35	152	32	5	98	8
2005	325	321	65	29	163	23	2	131	4
2006	430	398	56	65	208	35	0	144	32
2007	470	442	36	61	205	38	3	217	28
2008	516	445	49	56	238	36	0	208	71
2009	687	618	68	68	292	52	3	346	69
2010	866	647	74	76	304	79	1	363	219
2011	1,074	845	76	92	406	72	6	503	229
2012	943	827	95	67	399	95	0	482	116
2013	1,286	1,170	151	92	482	172	0	663	116
2014	1,302	1,156	124	116	415	216	22	619	146
2015	1,567	1,334	132	67	464	229	2	834	233
2016	2,016	1,583	123	121	584	222	2	1,035	433
2017	1,941	1,587	153	139	553	253	2	1,078	354
2018	2,986	2,501	181	191	915	330	3	1,792	485
2019	3,716	3,067	232	246	1,286	412	10	2,081	649
2020	2,969	2,636	218	197	1,059	378	3	1,855	333
2021	2,788	2,562	204	235	1,055	310	15	1,859	226
2022	2,474	2,291	160	205	1,031	203	11	1,688	183
2023	3,297	3,008	253	246	1,239	544	23	2,237	289
2024	3,229	2,999	196	205	1,330	281	5	2,193	230
2025	2,990	2,836	206	228	1,189	273	15	2,262	154
2026	1,411	1,346	114	98	569	128	5	1,063	65

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 Ciprofloxacin, 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 Ciprofloxacin, by the year in which FDA received them
Year	Reports
2004	275
2005	321
2006	429
2007	474
2008	514
2009	695
2010	748
2011	1,232
2012	1,079
2013	1,302
2014	1,323
2015	1,694
2016	2,130
2017	2,038
2018	3,193
2019	3,954
2020	2,998
2021	2,883
2022	2,392
2023	3,196
2024	3,105
2025	2,519
2026	1,076

Reports that name Ciprofloxacin, 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 Ciprofloxacin
Age	Reports	Share
Under 2	181	0.5%
2 to 11	452	1.1%
12 to 17	499	1.3%
18 to 44	8,104	20.5%
45 to 64	9,757	24.7%
65 to 74	6,346	16%
75 and over	6,207	15.7%
Age not given	8,024	20.3%

Sex of the patient in the reports that name Ciprofloxacin
Sex	Reports	Share
Female	20,068	50.7%
Male	16,262	41.1%
Unknown or not given	3,240	8.2%

Type of reporter in the reports that name Ciprofloxacin
Reporter	Reports	Share
Physician	9,732	24.6%
Pharmacist	3,264	8.2%
Other health professional	14,029	35.5%
Lawyer	165	0.4%
Consumer or non-health professional	10,116	25.6%
Not given	2,264	5.7%

Age and sex are as the report gives them. The reporter is the primary source in the report. 31.3% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Ciprofloxacin record
Indication as recorded (MedDRA)	Reports	Share
Urinary tract infection	5,076	12.8%
Prostatitis	1,153	2.9%
Infection	1,046	2.6%
Diverticulitis	613	1.5%
Antibiotic therapy	555	1.4%
Cystitis	482	1.2%

The reporter fills in the indication, and the field is often empty. Each share is of all 39,570 reports.

Drugs in the same reports

Other drugs that the reports of Ciprofloxacin name, in any role, in order of name
Drug	Reports that name the two
Acetaminophen	1,423
Amoxicillin	1,247
Aspirin	1,746
Fluconazole	1,502
Furosemide	1,465
Meropenem	1,523
Metronidazole	2,930
Omeprazole	1,434
Prednisone	2,481
Vancomycin	1,825

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.

Pages near this one

Ciprofloxacin hydrochloride same ingredient
Cipro same ingredient
Baxdela same class
Ciprofloxacin hcl same class
Levofloxacin same class
Ciprodex next in the A to Z list
Ciprobay next in the A to Z list
Ciprofloxacin Lactate next in the A to Z list
Cipramil next in the A to Z list
Ciprofloxacin Monohydrochloride next in the A to Z list
Cipralex next in the A to Z list
Ciprofloxacine next in the A to Z list

These links are for navigation. No count selected them. The class page lists each drug of the class.

Official pages

DailyMed labels for CiprofloxacinThe 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. Ciprofloxacin: adverse event reports that FDA received. https://reportedreactions.com/drug/ciprofloxacin/ Source: U.S. Food and Drug Administration, openFDA Drug Adverse Event (FAERS) files, release of 1 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 1 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 Oct 2026. A class is the pharmacologic class (EPC) of the FDA label.

A report is in the count when it names Ciprofloxacin as a suspect or interacting product. The 32,516 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 Ciprofloxacin 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 Ciprofloxacin?

No. It is a count of what people reported to FDA: 39,570 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?

Other health professional (35.5%), consumer or non-health professional (25.6%) and physician (24.6%). 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.

To the top of the page