Betadine (povidone-iodine) adverse event reports that FDA received

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

Name type: Brand name
Generic name: Povidone-iodine
Also reported as: Betadine Ophthalmic

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 February 2004 to June 2026, FDA received 1,126 adverse event reports that name Betadine. In these reports the drug is a suspect or interacting product.

In the same period, 1,115 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 53 reports in the 12 months to June 2026 and 37 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, 53 (under 0.1%) name Betadine. Reports for male patients were 21.7% of the reports that name Betadine and 34.6% 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 Betadine 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 5 reports that name Betadine.
In January to March 2026, FDA received 20.
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 93 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 1,092 of the 1,126 reports (97%).

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 93 terms.

Reaction terms in the reports that name Betadine, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 1,126 reports
Drug hypersensitivityan allergic-type reaction (the term names a medicine)	215	19.1%
Toxic anterior segment syndrome	109	9.7%
Hypersensitivityan allergic-type reaction	88	7.8%
Endophthalmitisinfection inside the eye	86	7.6%
Eye pain	84	7.5%
Rashskin rash	72	6.4%
Eye irritation	64	5.7%
Off label useused for a purpose or in a way not on the label	48	4.3%
Vision blurredblurred vision	48	4.3%
Anaphylactic reactiona severe, sudden allergic reaction	38	3.4%
Corneal oedema	38	3.4%
Visual impairmentreduced vision	38	3.4%
Pruritusitching	31	2.8%
Anterior chamber cell	29	2.6%
Hypopyon	27	2.4%
Ocular hyperaemiaa red eye	26	2.3%
Oliguria	26	2.3%
Renal failure acute	26	2.3%
Lacrimation increasedwatery eyes	25	2.2%
Haematuriablood in the urine	23	2%
Visual acuity reducedreduced sharpness of vision	23	2%
Foreign body sensation in eyes	22	2%
Urticariahives	22	2%
Anterior chamber fibrin	20	1.8%
Drug ineffectivethe medicine did not work as expected	20	1.8%
Lymphopenia	19	1.7%
Punctate keratitis	19	1.7%
Hypotensionlow blood pressure	17	1.5%
Rash maculo-papulara rash of flat and raised spots	16	1.4%
Anaphylactic shocka severe allergic reaction with collapse	15	1.3%
Corneal epithelium defect	15	1.3%
Corneal abrasion	14	1.2%
Post procedural complicationa complication after a procedure	14	1.2%
Eye swellinga swollen eye	13	1.2%
Postoperative infection	13	1.2%
Acute kidney injurysudden loss of kidney function	12	1.1%
Eyelid oedemaa swollen eyelid	12	1.1%
Headachehead pain	12	1.1%
Pyrexiafever	12	1.1%
Vitreous floatersfloaters in vision	12	1.1%
Blistera blister	11	1%
Corneal opacity	11	1%
Dry eye	11	1%
Photophobiasensitivity to light	11	1%
Poor quality drug administered	11	1%
Sudden deatha sudden death	11	1%
Toxic skin eruption	11	1%
Angioedemadeep swelling of skin or mucous membranes	10	0.9%
Blindnessloss of sight	10	0.9%
Erythemaskin redness	10	0.9%

Download all 93 terms of Betadine (CSV)

The counts add to more than 1,126 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 Povidone-iodine with a page, in the order generic names, brand names, names as reported
Name	Name type	Reports
Povidone-iodine	Generic name	523
Betadine (this page)	Brand name	1,126

Sum of the separately reported names: 1,649. 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 Betadine, 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	12	11	0	0	5	4	3	1
2005	5	3	0	2	3	0	1	2
2006	15	8	0	1	0	0	7	7
2007	3	3	0	0	0	0	3	0
2008	9	8	1	4	2	0	5	1
2009	8	8	0	0	5	1	5	0
2010	37	34	1	3	30	0	6	3
2011	9	9	0	0	2	0	8	0
2012	37	33	0	1	6	0	28	4
2013	33	28	1	2	0	1	25	5
2014	54	45	0	0	11	0	35	9
2015	74	41	0	2	7	2	35	33
2016	126	83	0	2	6	1	79	43
2017	104	48	0	0	13	4	36	56
2018	114	74	0	6	34	6	44	40
2019	118	50	0	5	24	2	31	68
2020	54	33	0	1	14	2	24	21
2021	88	42	0	7	15	2	35	46
2022	47	26	0	2	20	1	16	21
2023	34	25	1	5	12	0	12	9
2024	60	27	0	0	9	1	20	33
2025	46	31	2	5	9	1	21	15
2026	39	24	13	1	3	0	16	15

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 Betadine, 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 Betadine, by the year in which FDA received them
Year	Reports
2004	11
2005	5
2006	16
2007	2
2008	9
2009	9
2010	36
2011	7
2012	42
2013	38
2014	65
2015	73
2016	129
2017	117
2018	108
2019	114
2020	50
2021	81
2022	46
2023	32
2024	56
2025	55
2026	25

Reports that name Betadine, 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 Betadine
Age	Reports	Share
Under 2	2	0.2%
2 to 11	1	0.1%
12 to 17	5	0.4%
18 to 44	98	8.7%
45 to 64	185	16.4%
65 to 74	193	17.1%
75 and over	158	14%
Age not given	484	43%

Sex of the patient in the reports that name Betadine
Sex	Reports	Share
Female	671	59.6%
Male	244	21.7%
Unknown or not given	211	18.7%

Type of reporter in the reports that name Betadine
Reporter	Reports	Share
Physician	363	32.2%
Pharmacist	28	2.5%
Other health professional	340	30.2%
Lawyer	0	0%
Consumer or non-health professional	374	33.2%
Not given	21	1.9%

Age and sex are as the report gives them. The reporter is the primary source in the report. 68.5% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Betadine record
Indication as recorded (MedDRA)	Reports	Share
Infection prophylaxis	73	6.5%
Preoperative care	72	6.4%
Intraocular lens implant	65	5.8%
Cataract operation	32	2.8%
Surgery	20	1.8%
Antibiotic prophylaxis	17	1.5%

The reporter fills in the indication, and the field is often empty. Each share is of all 1,126 reports.

Drugs in the same reports

Other drugs that the reports of Betadine name, in any role, in order of name
Drug	Reports that name the two
Acetaminophen	31
Dexamethasone	50
Epinephrine	52
Eylea	80
Iodine	38
Lidocaine	78
Lovenox	32
Morphine sulfate	32
Neurontin	44
Propofol	88

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

Povidone-iodine same ingredient
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These links are for navigation. No count selected them.

Official pages

DailyMed labels for BetadineThe 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. Betadine: adverse event reports that FDA received. https://reportedreactions.com/drug/betadine/ 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 Betadine as a suspect or interacting product. The 1,115 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 Betadine 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 Betadine?

No. It is a count of what people reported to FDA: 1,126 reports from February 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?

Consumer or non-health professional (33.2%), physician (32.2%) and other health professional (30.2%). 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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