Dietary Supplement adverse event reports that FDA received

Name: Reaction terms in FDA adverse event reports that name Dietary Supplement
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.

Reports on file

From August 2005 to June 2026, FDA received 1,512 adverse event reports that name Dietary Supplement. The name is as reporters wrote it. In these reports the drug is a suspect or interacting product.

In the same period, 4,069 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 233 reports in the 12 months to June 2026 and 285 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 Dietary Supplement 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 70 reports that name Dietary Supplement.
In January to March 2026, FDA received 39.
In April to June 2025, FDA received 73.

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 474 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 1,484 of the 1,512 reports (98.1%).

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 474 terms.

Reaction terms in the reports that name Dietary Supplement, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 1,512 reports
Off label useused for a purpose or in a way not on the label	392	25.9%
Drug ineffectivethe medicine did not work as expected	361	23.9%
Dyspnoeashortness of breath	355	23.5%
Headachehead pain	334	22.1%
Hypertensionhigh blood pressure	329	21.8%
Condition aggravatedthe condition being treated got worse	328	21.7%
Vomitingbeing sick	317	21%
General physical health deteriorationgeneral decline in health	314	20.8%
Fatiguetiredness	306	20.2%
Blood cholesterol increasedraised cholesterol	305	20.2%
Nauseafeeling sick	288	19%
Drug intolerancethe medicine was not tolerated	279	18.5%
Painpain, site not specified	277	18.3%
Abdominal discomfortstomach discomfort	276	18.3%
Fibromyalgia	272	18%
Swelling	272	18%
Asthma	267	17.7%
Arthropathy	264	17.5%
Rashskin rash	264	17.5%
Alopeciahair loss	258	17.1%
Rheumatoid arthritisrheumatoid arthritis, an inflammatory joint disease	257	17%
Drug hypersensitivityan allergic-type reaction (the term names a medicine)	254	16.8%
Wheezing	251	16.6%
Arthralgiajoint pain	240	15.9%
Diarrhoealoose or frequent stools	238	15.7%
Hepatic enzyme increasedraised liver enzymes	233	15.4%
Infusion related reactiona reaction during or soon after an infusion	233	15.4%
Duodenal ulcer perforation	231	15.3%
Glossodynia	229	15.1%
Nasopharyngitisa cold	226	14.9%
Product use in unapproved indicationused for a purpose not on the label	226	14.9%
Systemic lupus erythematosuslupus, an autoimmune disease	223	14.7%
Hand deformity	219	14.5%
Dizzinesslight-headedness or unsteadiness	218	14.4%
Pemphigus	218	14.4%
Dry mouth	216	14.3%
Decreased appetitereduced appetite	215	14.2%
Psoriatic arthropathy	215	14.2%
Helicobacter infection	214	14.2%
Abdominal pain upperupper stomach pain	211	14%
Liver injury	209	13.8%
Joint swellinga swollen joint	208	13.8%
Hypersensitivityan allergic-type reaction	207	13.7%
Contraindicated product administered	205	13.6%
Hypoaesthesianumbness	205	13.6%
Pericarditisinflammation of the sac around the heart	205	13.6%
Wound	205	13.6%
Musculoskeletal stiffnessstiffness in muscles or joints	201	13.3%
Type 2 diabetes mellitustype 2 diabetes	200	13.2%
Pyrexiafever	199	13.2%

Download all 474 terms of Dietary Supplement (CSV)

The counts add to more than 1,512 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 Dietary Supplement, 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	0	0	0	0	0	0	0	0	0
2005	1	1	0	0	0	0	0	1	0
2006	0	0	0	0	0	0	0	0	0
2007	0	0	0	0	0	0	0	0	0
2008	0	0	0	0	0	0	0	0	0
2010	2	2	1	0	1	0	0	0	0
2011	0	0	0	0	0	0	0	0	0
2012	5	5	0	1	3	0	0	1	0
2013	14	12	9	2	2	2	0	1	2
2014	14	11	0	2	7	3	0	5	3
2015	2	2	0	0	0	1	0	1	0
2016	3	2	0	0	2	0	0	2	1
2017	3	3	0	1	2	0	1	2	0
2018	2	2	1	0	0	0	0	1	0
2019	2	2	0	0	1	0	0	1	0
2020	8	4	3	0	2	0	0	0	4
2021	27	21	2	2	13	0	0	18	6
2022	242	215	58	29	95	46	0	175	27
2023	258	202	82	76	130	71	10	169	56
2024	386	288	127	155	208	125	43	245	98
2025	328	231	91	92	137	82	43	201	97
2026	215	192	84	62	95	63	38	166	23

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 Dietary Supplement, 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 Dietary Supplement, by the year in which FDA received them
Year	Reports
2005	1
2010	1
2011	2
2012	4
2013	14
2014	15
2015	7
2016	10
2017	4
2018	9
2019	14
2020	35
2021	96
2022	265
2023	287
2024	385
2025	254
2026	109

Reports that name Dietary Supplement, 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 Dietary Supplement
Age	Reports	Share
Under 2	7	0.5%
2 to 11	13	0.9%
12 to 17	9	0.6%
18 to 44	269	17.8%
45 to 64	273	18.1%
65 to 74	111	7.3%
75 and over	253	16.7%
Age not given	577	38.2%

Sex of the patient in the reports that name Dietary Supplement
Sex	Reports	Share
Female	834	55.2%
Male	395	26.1%
Unknown or not given	283	18.7%

Type of reporter in the reports that name Dietary Supplement
Reporter	Reports	Share
Physician	328	21.7%
Pharmacist	55	3.6%
Other health professional	600	39.7%
Lawyer	0	0%
Consumer or non-health professional	511	33.8%
Not given	18	1.2%

Age and sex are as the report gives them. The reporter is the primary source in the report. 35.3% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Dietary Supplement record
Indication as recorded (MedDRA)	Reports	Share
Vitamin supplementation	97	6.4%
Rheumatoid arthritis	52	3.4%
Arthralgia	16	1.1%
Hot flush	16	1.1%
Headache	13	0.9%
Parenteral nutrition	12	0.8%

The reporter fills in the indication, and the field is often empty. Each share is of all 1,512 reports.

Pages near this one

Didanosine next in the A to Z list
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These links are for navigation. No count selected them.

Official pages

DailyMed labels for Dietary SupplementThe 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. Dietary Supplement: adverse event reports that FDA received. https://reportedreactions.com/drug/dietary-supplement/ 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 Dietary Supplement as a suspect or interacting product. The 4,069 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 Dietary Supplement 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 Dietary Supplement?

No. It is a count of what people reported to FDA: 1,512 reports from August 2005 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 (39.7%), consumer or non-health professional (33.8%) and physician (21.7%). 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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