Thiamine hydrochloride adverse event reports that FDA received

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

Name type: Generic name
Also reported as: Thiamine Hydrochloride Injection Usp

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 2007 to June 2026, FDA received 770 adverse event reports that name Thiamine hydrochloride. In these reports the drug is a suspect or interacting product.

In the same period, 2,535 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 82 reports in the 12 months to June 2026 and 151 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, 82 (under 0.1%) name Thiamine hydrochloride. Reports from other health professionals were 64.4% of the reports that name Thiamine hydrochloride 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 Thiamine hydrochloride 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 25 reports that name Thiamine hydrochloride.
In January to March 2026, FDA received 22.
In April to June 2025, FDA received 36.

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 269 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 748 of the 770 reports (97.1%).

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 269 terms.

Reaction terms in the reports that name Thiamine hydrochloride, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 770 reports
Off label useused for a purpose or in a way not on the label	288	37.4%
Painpain, site not specified	238	30.9%
Product use in unapproved indicationused for a purpose not on the label	198	25.7%
Drug ineffectivethe medicine did not work as expected	196	25.5%
Treatment failurethe treatment did not work	167	21.7%
Condition aggravatedthe condition being treated got worse	165	21.4%
Migraine	165	21.4%
Drug hypersensitivityan allergic-type reaction (the term names a medicine)	160	20.8%
Gastrooesophageal reflux diseaseacid reflux	157	20.4%
Neck pain	155	20.1%
Injection site reactiona reaction where the injection was given	152	19.7%
Nauseafeeling sick	151	19.6%
Rheumatic fever	151	19.6%
Infusion related reactiona reaction during or soon after an infusion	150	19.5%
Pericarditisinflammation of the sac around the heart	149	19.4%
Headachehead pain	148	19.2%
Pemphigus	148	19.2%
Sleep disordera sleep problem	147	19.1%
Drug intolerancethe medicine was not tolerated	145	18.8%
Psoriatic arthropathy	145	18.8%
Confusional stateconfusion	144	18.7%
Rashskin rash	144	18.7%
Rheumatoid arthritisrheumatoid arthritis, an inflammatory joint disease	144	18.7%
Synovitis	144	18.7%
Systemic lupus erythematosuslupus, an autoimmune disease	144	18.7%
Type 2 diabetes mellitustype 2 diabetes	143	18.6%
Swelling	141	18.3%
Wound	139	18.1%
Contraindicated product administered	137	17.8%
C-reactive protein increased	136	17.7%
Therapeutic product effect incomplete	136	17.7%
Dyspnoeashortness of breath	135	17.5%
Onychomadesis	135	17.5%
Therapeutic product effect decreased	132	17.1%
Ill-defined disordera condition that was not clearly described	126	16.4%
Product use issuea problem in how the product was used	126	16.4%
C-reactive protein abnormal	125	16.2%
Hypoaesthesianumbness	122	15.8%
Onychomycosis	120	15.6%
Maternal exposure during pregnancythe mother took the medicine during pregnancy	116	15.1%
Memory impairmentmemory problems	109	14.2%
Paraesthesiatingling or pins and needles	109	14.2%
Malaisegeneral feeling of being unwell	108	14%
Dyspepsiaindigestion	107	13.9%
Epilepsy	107	13.9%
Blepharospasm	106	13.8%
Taste disorder	104	13.5%
Vomitingbeing sick	103	13.4%
Mobility decreasedreduced ability to move about	99	12.9%
Hypersensitivityan allergic-type reaction	97	12.6%

Download all 269 terms of Thiamine hydrochloride (CSV)

The counts add to more than 770 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 Thiamine hydrochloride with a page, in the order generic names, brand names, names as reported
Name	Name type	Reports
Thiamine hydrochloride (this page)	Generic name	770
Thiamine	Brand name	845

Sum of the separately reported names: 1,615. 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 Thiamine hydrochloride, 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
2007	2	2	0	0	0	0	0	2	0
2008	0	0	0	0	0	0	0	0	0
2009	1	1	0	0	0	0	0	1	0
2010	1	1	1	1	0	0	0	0	0
2011	2	2	0	0	1	0	0	2	0
2012	2	2	0	0	0	0	0	2	0
2013	2	2	0	0	1	0	0	2	0
2014	4	3	0	0	0	0	0	3	1
2015	0	0	0	0	0	0	0	0	0
2016	6	4	1	0	3	0	0	2	2
2017	2	2	0	0	2	0	0	0	0
2018	0	0	0	0	0	0	0	0	0
2019	16	14	2	0	9	0	2	7	2
2020	31	31	2	2	12	0	1	19	0
2021	49	49	5	6	16	0	0	42	0
2022	95	93	7	18	29	0	0	82	2
2023	100	99	47	41	49	15	15	86	1
2024	180	177	76	68	105	65	60	168	3
2025	187	187	124	106	132	100	93	178	0
2026	90	89	47	51	66	43	43	89	1

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 Thiamine hydrochloride, 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 Thiamine hydrochloride, by the year in which FDA received them
Year	Reports
2007	8
2009	1
2010	1
2011	4
2012	3
2013	1
2014	7
2015	4
2016	10
2017	11
2018	5
2019	23
2020	79
2021	78
2022	82
2023	100
2024	187
2025	119
2026	47

Reports that name Thiamine hydrochloride, 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 Thiamine hydrochloride
Age	Reports	Share
Under 2	0	0%
2 to 11	1	0.1%
12 to 17	1	0.1%
18 to 44	282	36.6%
45 to 64	146	19%
65 to 74	87	11.3%
75 and over	76	9.9%
Age not given	177	23%

Sex of the patient in the reports that name Thiamine hydrochloride
Sex	Reports	Share
Female	401	52.1%
Male	243	31.6%
Unknown or not given	126	16.4%

Type of reporter in the reports that name Thiamine hydrochloride
Reporter	Reports	Share
Physician	136	17.7%
Pharmacist	57	7.4%
Other health professional	496	64.4%
Lawyer	1	0.1%
Consumer or non-health professional	73	9.5%
Not given	7	0.9%

Age and sex are as the report gives them. The reporter is the primary source in the report. 4.7% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Thiamine hydrochloride record
Indication as recorded (MedDRA)	Reports	Share
Vitamin supplementation	23	3%
Nutritional supplementation	18	2.3%
Hyperemesis gravidarum	16	2.1%
Vitamin b complex deficiency	11	1.4%
Foetal exposure during pregnancy	10	1.3%
Pneumonia	7	0.9%

The reporter fills in the indication, and the field is often empty. Each share is of all 770 reports.

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These links are for navigation. No count selected them.

Official pages

DailyMed labels for Thiamine hydrochlorideThe 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. Thiamine hydrochloride: adverse event reports that FDA received. https://reportedreactions.com/drug/thiamine-hydrochloride/ 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 Thiamine hydrochloride as a suspect or interacting product. The 2,535 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 Thiamine hydrochloride 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 Thiamine hydrochloride?

No. It is a count of what people reported to FDA: 770 reports from January 2007 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 (64.4%), physician (17.7%) and consumer or non-health professional (9.5%). 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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