Levoxyl (levothyroxine sodium) adverse event reports that FDA received

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

Name type: Brand name
Generic name: Levothyroxine sodium
Class: l-Thyroxine

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 2004 to June 2026, FDA received 3,382 adverse event reports that name Levoxyl. In these reports the drug is a suspect or interacting product.

In the same period, 13,214 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 70 reports in the 12 months to June 2026 and 30 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, 70 (under 0.1%) name Levoxyl. Reports from consumers or other non-health professionals were 81.4% of the reports that name Levoxyl 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 Levoxyl 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 13 reports that name Levoxyl.
In January to March 2026, FDA received 8.
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 247 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 all 3,382 reports.

The site keeps a term for a year only if two or more reports of that year record it.

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 247 terms.

Reaction terms in the reports that name Levoxyl, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 3,382 reports
Drug ineffectivethe medicine did not work as expected	399	11.8%
Fatiguetiredness	351	10.4%
Malaisegeneral feeling of being unwell	288	8.5%
Feeling abnormalfeeling odd or not right	256	7.6%
Alopeciahair loss	231	6.8%
Weight increasedweight gain	228	6.7%
Palpitationsawareness of the heartbeat	179	5.3%
Headachehead pain	175	5.2%
Insomniadifficulty sleeping	165	4.9%
Astheniaweakness or lack of energy	139	4.1%
Dizzinesslight-headedness or unsteadiness	139	4.1%
Blood thyroid stimulating hormone increased	137	4.1%
Nauseafeeling sick	131	3.9%
Pruritusitching	131	3.9%
Thyroid function test abnormal	131	3.9%
Weight decreasedweight loss	131	3.9%
Rashskin rash	128	3.8%
Dyspnoeashortness of breath	122	3.6%
Diarrhoealoose or frequent stools	113	3.3%
Heart rate increaseda fast heart rate reading	109	3.2%
Product quality issuea problem with the product itself	109	3.2%
Anxiety	100	3%
Hypersensitivityan allergic-type reaction	96	2.8%
Hyperhidrosisexcessive sweating	95	2.8%
Drug hypersensitivityan allergic-type reaction (the term names a medicine)	94	2.8%
Blood thyroid stimulating hormone decreased	89	2.6%
Painpain, site not specified	86	2.5%
Urticariahives	86	2.5%
Arthralgiajoint pain	82	2.4%
Tremorshaking	79	2.3%
Deaththe patient died; cause not stated by this term	76	2.2%
Hyperthyroidismoveractive thyroid	74	2.2%
Oral discomfort	73	2.2%
Nervousness	72	2.1%
Abdominal discomfortstomach discomfort	70	2.1%
Drug interactionan interaction between medicines	67	2%
Dyspepsiaindigestion	66	2%
Myalgiamuscle pain	66	2%
Blood pressure increaseda raised blood pressure reading	64	1.9%
Dysphagiadifficulty swallowing	64	1.9%
Hypothyroidismunderactive thyroid	62	1.8%
Muscle spasmsmuscle cramps	61	1.8%
Abdominal distensiona bloated abdomen	58	1.7%
Chest pain	57	1.7%
Depressionlow mood	56	1.7%
Drug intolerancethe medicine was not tolerated	56	1.7%
Abdominal pain upperupper stomach pain	54	1.6%
Constipation	54	1.6%
Somnolencedrowsiness	50	1.5%
Blood thyroid stimulating hormone abnormal	49	1.4%

Download all 247 terms of Levoxyl (CSV)

The counts add to more than 3,382 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 Levothyroxine with a page, in the order generic names, brand names, names as reported
Name	Name type	Reports
Levothyroxine	Generic name	15,937
Levothyroxine sodium	Generic name	14,372
Euthyrox	Brand name	3,499
Levoxyl (this page)	Brand name	3,382
Synthroid	Brand name	26,831
Tirosint	Brand name	2,276

Sum of the separately reported names: 66,297. 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 Levoxyl, 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	83	76	1	2	12	0	0	62	7
2005	50	44	1	4	7	0	0	36	6
2006	122	20	2	1	10	1	0	7	102
2007	229	23	1	0	9	2	0	13	206
2008	240	44	12	4	10	1	1	19	196
2009	189	29	3	1	15	2	0	12	160
2010	190	37	0	4	17	3	0	21	153
2011	155	41	6	2	8	5	0	30	114
2012	181	69	8	1	10	0	0	57	112
2013	566	156	2	1	21	3	0	139	410
2014	244	60	2	5	5	4	0	50	184
2015	159	40	2	0	12	4	0	31	119
2016	144	27	0	1	6	1	0	23	117
2017	141	33	2	0	11	2	0	27	108
2018	86	26	2	0	6	0	0	23	60
2019	90	27	0	0	11	0	0	21	63
2020	70	25	0	0	2	0	0	24	45
2021	46	17	0	0	2	0	0	16	29
2022	109	18	1	0	1	1	0	18	91
2023	87	23	0	0	3	1	0	22	64
2024	111	83	72	0	1	0	0	11	28
2025	64	16	0	0	2	1	0	14	48
2026	26	4	0	0	1	0	0	4	22

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 Levoxyl, 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 Levoxyl, by the year in which FDA received them
Year	Reports
2004	75
2005	54
2006	24
2007	197
2008	261
2009	38
2010	363
2011	199
2012	246
2013	574
2014	248
2015	154
2016	146
2017	131
2018	86
2019	89
2020	67
2021	44
2022	117
2023	76
2024	105
2025	67
2026	21

Reports that name Levoxyl, 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 Levoxyl
Age	Reports	Share
Under 2	8	0.2%
2 to 11	9	0.3%
12 to 17	7	0.2%
18 to 44	212	6.3%
45 to 64	653	19.3%
65 to 74	330	9.8%
75 and over	196	5.8%
Age not given	1,967	58.2%

Sex of the patient in the reports that name Levoxyl
Sex	Reports	Share
Female	2,457	72.6%
Male	275	8.1%
Unknown or not given	650	19.2%

Type of reporter in the reports that name Levoxyl
Reporter	Reports	Share
Physician	220	6.5%
Pharmacist	151	4.5%
Other health professional	177	5.2%
Lawyer	2	0.1%
Consumer or non-health professional	2,754	81.4%
Not given	78	2.3%

Age and sex are as the report gives them. The reporter is the primary source in the report. 95.8% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Levoxyl record
Indication as recorded (MedDRA)	Reports	Share
Hypothyroidism	1,028	30.4%
Thyroid disorder	322	9.5%
Autoimmune thyroiditis	121	3.6%
Thyroidectomy	57	1.7%
Thyroid hormone replacement therapy	45	1.3%
Basedow's disease	20	0.6%

The reporter fills in the indication, and the field is often empty. Each share is of all 3,382 reports.

Pages near this one

Levothyroxine same ingredient
Levothyroxine sodium same ingredient
Euthyrox same ingredient
Synthroid same ingredient
Tirosint same ingredient
NP Thyroid same class
Levulan Kerastick next in the A to Z list
Lexapro next in the A to Z list
Levothyroxin next in the A to Z list
Lexiscan(r) (regadenoson) next in the A to Z list
Levothyrox next in the A to Z list
Lexiva 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 LevoxylThe 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. Levoxyl: adverse event reports that FDA received. https://reportedreactions.com/drug/levoxyl/ 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 Levoxyl as a suspect or interacting product. The 13,214 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 Levoxyl 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 Levoxyl?

No. It is a count of what people reported to FDA: 3,382 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?

Consumer or non-health professional (81.4%), physician (6.5%) and other health professional (5.2%). 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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