Iodine adverse event reports that FDA received

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

Name type: Generic name
Also reported as: Iodine Solution, Iodine Nos

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 2,051 adverse event reports that name Iodine. In these reports the drug is a suspect or interacting product.

In the same period, 1,572 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 162 reports in the 12 months to June 2026 and 233 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, 162 (under 0.1%) name Iodine. Reports from consumers or other non-health professionals were 19.5% of the reports that name Iodine 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 Iodine 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 42 reports that name Iodine.
In January to March 2026, FDA received 32.
In April to June 2025, FDA received 40.

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 381 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 2,003 of the 2,051 reports (97.7%).

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 381 terms.

Reaction terms in the reports that name Iodine, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 2,051 reports
Drug hypersensitivityan allergic-type reaction (the term names a medicine)	1,079	52.6%
Nauseafeeling sick	338	16.5%
Dyspnoeashortness of breath	310	15.1%
Fatiguetiredness	288	14%
Diarrhoealoose or frequent stools	268	13.1%
Arthralgiajoint pain	261	12.7%
Headachehead pain	243	11.8%
Pruritusitching	243	11.8%
Vomitingbeing sick	229	11.2%
Off label useused for a purpose or in a way not on the label	217	10.6%
Dizzinesslight-headedness or unsteadiness	216	10.5%
Pyrexiafever	214	10.4%
Falla fall	210	10.2%
Malaisegeneral feeling of being unwell	208	10.1%
Drug ineffectivethe medicine did not work as expected	207	10.1%
Abdominal painstomach or belly pain	205	10%
Abdominal pain upperupper stomach pain	201	9.8%
Decreased appetitereduced appetite	194	9.5%
Rashskin rash	180	8.8%
Astheniaweakness or lack of energy	177	8.6%
Insomniadifficulty sleeping	176	8.6%
Painpain, site not specified	173	8.4%
Tachycardiafast heart rate	162	7.9%
Psoriatic arthropathy	155	7.6%
Chillschills or shivering	154	7.5%
Syncopefainting	153	7.5%
Haemorrhagic stroke	152	7.4%
Systemic lupus erythematosuslupus, an autoimmune disease	152	7.4%
Type 2 diabetes mellitustype 2 diabetes	147	7.2%
Rheumatoid arthritisrheumatoid arthritis, an inflammatory joint disease	146	7.1%
Swelling	146	7.1%
Product use in unapproved indicationused for a purpose not on the label	143	7%
Blindnessloss of sight	140	6.8%
Coma	140	6.8%
Cough	140	6.8%
Eye pain	139	6.8%
Ocular discomfort	139	6.8%
Synovitis	139	6.8%
Amaurosis fugax	138	6.7%
Haematemesis	138	6.7%
Urticariahives	136	6.6%
Head discomfortdiscomfort in the head	135	6.6%
Altered state of consciousness	133	6.5%
Infusion related reactiona reaction during or soon after an infusion	131	6.4%
Ascitesfluid in the abdomen	130	6.3%
Blood pressure increaseda raised blood pressure reading	130	6.3%
Cardio-respiratory arrestthe heart and breathing stopped	130	6.3%
Pemphigus	130	6.3%
Haematuriablood in the urine	129	6.3%
Sepsisa severe body-wide response to infection	129	6.3%

Download all 381 terms of Iodine (CSV)

The counts add to more than 2,051 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 Iodine, 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	17	14	1	8	11	0	0	2	3
2005	6	6	0	1	4	0	1	3	0
2006	3	3	0	2	2	0	0	3	0
2007	7	5	0	0	2	0	0	4	2
2008	6	6	0	0	1	1	0	5	0
2009	6	4	0	0	1	0	0	4	2
2010	7	7	0	1	2	2	0	4	0
2011	9	8	1	1	4	0	0	4	1
2012	23	6	0	1	2	0	0	6	17
2013	84	18	0	3	7	1	0	12	66
2014	92	10	0	1	3	0	0	8	82
2015	109	13	0	2	3	0	0	9	96
2016	190	32	5	3	5	1	0	27	158
2017	123	19	1	0	9	1	0	13	104
2018	122	36	1	1	16	0	8	24	86
2019	264	45	1	0	13	0	6	35	219
2020	112	33	1	1	22	1	0	26	79
2021	97	66	0	3	30	1	0	60	31
2022	73	52	9	2	15	1	1	42	21
2023	94	70	21	4	22	0	0	60	24
2024	195	183	114	49	68	29	20	160	12
2025	236	223	157	134	147	132	56	215	13
2026	176	172	103	85	94	80	55	163	4

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 Iodine, 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 Iodine, by the year in which FDA received them
Year	Reports
2004	16
2005	6
2006	3
2007	8
2008	6
2009	4
2010	10
2011	11
2012	30
2013	93
2014	108
2015	124
2016	207
2017	134
2018	156
2019	216
2020	106
2021	87
2022	89
2023	115
2024	253
2025	195
2026	74

Reports that name Iodine, 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 Iodine
Age	Reports	Share
Under 2	7	0.3%
2 to 11	2	0.1%
12 to 17	6	0.3%
18 to 44	314	15.3%
45 to 64	462	22.5%
65 to 74	298	14.5%
75 and over	244	11.9%
Age not given	718	35%

Sex of the patient in the reports that name Iodine
Sex	Reports	Share
Female	1,309	63.8%
Male	361	17.6%
Unknown or not given	381	18.6%

Type of reporter in the reports that name Iodine
Reporter	Reports	Share
Physician	732	35.7%
Pharmacist	51	2.5%
Other health professional	843	41.1%
Lawyer	3	0.1%
Consumer or non-health professional	400	19.5%
Not given	22	1.1%

Age and sex are as the report gives them. The reporter is the primary source in the report. 58.4% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Iodine record
Indication as recorded (MedDRA)	Reports	Share
Migraine	29	1.4%
Thyrotoxic crisis	22	1.1%
Computerised tomogram	18	0.9%
Rheumatoid arthritis	14	0.7%
Nutritional supplementation	11	0.5%
Psoriatic arthropathy	9	0.4%

The reporter fills in the indication, and the field is often empty. Each share is of all 2,051 reports.

Drugs in the same reports

Other drugs that the reports of Iodine name, in any role, in order of name
Drug	Reports that name the two
Acetaminophen	454
Actemra	217
Adalimumab	349
Alendronate sodium	229
Celecoxib	331
Codeine	322
Folic acid	222
Methotrexate	235
Prednisone	243
Tramadol hydrochloride	263

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 IodineThe 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. Iodine: adverse event reports that FDA received. https://reportedreactions.com/drug/iodine/ 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 Iodine as a suspect or interacting product. The 1,572 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 Iodine 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 Iodine?

No. It is a count of what people reported to FDA: 2,051 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?

Other health professional (41.1%), physician (35.7%) and consumer or non-health professional (19.5%). 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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