Gemfibrozil adverse event reports that FDA received

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

Name type: Generic name
Class: Peroxisome proliferator receptor alpha agonist
Also reported as: Gemfibrozil 600mg

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 1,807 adverse event reports that name Gemfibrozil. In these reports the drug is a suspect or interacting product.

In the same period, 9,645 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 43 reports in the 12 months to June 2026 and 44 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, 43 (under 0.1%) name Gemfibrozil. Reports from consumers or other non-health professionals were 17.3% of the reports that name Gemfibrozil 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 Gemfibrozil 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 6 reports that name Gemfibrozil.
In January to March 2026, FDA received 13.
In April to June 2025, FDA received 4.

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 206 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 1,805 of the 1,807 reports (99.9%).

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 206 terms.

Reaction terms in the reports that name Gemfibrozil, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 1,807 reports
Rhabdomyolysismuscle breakdown	378	20.9%
Drug interactionan interaction between medicines	253	14%
Myalgiamuscle pain	152	8.4%
Renal failure acute	145	8%
Drug hypersensitivityan allergic-type reaction (the term names a medicine)	126	7%
Completed suicidedeath by suicide	116	6.4%
Astheniaweakness or lack of energy	99	5.5%
Fatiguetiredness	95	5.3%
Blood creatine phosphokinase increased	92	5.1%
Nauseafeeling sick	88	4.9%
Drug ineffectivethe medicine did not work as expected	82	4.5%
Muscular weaknessmuscle weakness	59	3.3%
Vomitingbeing sick	59	3.3%
Diarrhoealoose or frequent stools	57	3.2%
Acute kidney injurysudden loss of kidney function	50	2.8%
Pain in extremitypain in an arm or leg	50	2.8%
Blood triglycerides increased	47	2.6%
Malaisegeneral feeling of being unwell	46	2.5%
Dizzinesslight-headedness or unsteadiness	44	2.4%
Blood cholesterol increasedraised cholesterol	43	2.4%
Muscle spasmsmuscle cramps	43	2.4%
Abdominal painstomach or belly pain	42	2.3%
Toxicity to various agentspoisoning or toxic effect of one or more substances	41	2.3%
Arthralgiajoint pain	40	2.2%
Aspartate aminotransferase increasedraised liver enzyme (AST)	40	2.2%
Deaththe patient died; cause not stated by this term	40	2.2%
Alanine aminotransferase increasedraised liver enzyme (ALT)	39	2.2%
Blood creatinine increasedraised creatinine, a kidney test	38	2.1%
Myopathy	37	2%
Treatment noncompliancethe treatment was not taken as directed	37	2%
Falla fall	36	2%
Gait disturbancedifficulty walking	36	2%
Rashskin rash	36	2%
Headachehead pain	34	1.9%
Hypertriglyceridaemia	34	1.9%
Chromaturia	32	1.8%
Dyspnoeashortness of breath	31	1.7%
Insomniadifficulty sleeping	31	1.7%
Painpain, site not specified	30	1.7%
Pruritusitching	29	1.6%
Renal failurekidney failure	29	1.6%
Weight decreasedweight loss	28	1.5%
Confusional stateconfusion	27	1.5%
Hypertensionhigh blood pressure	27	1.5%
Vision blurredblurred vision	27	1.5%
Liver function test abnormal	26	1.4%
Loss of consciousnesspassing out	26	1.4%
Metabolic acidosistoo much acid in the body fluids	25	1.4%
Myositis	25	1.4%
Renal impairmentreduced kidney function	25	1.4%

Download all 206 terms of Gemfibrozil (CSV)

The counts add to more than 1,807 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 Gemfibrozil with a page, in the order generic names, brand names, names as reported
Name	Name type	Reports
Gemfibrozil (this page)	Generic name	1,807
Lopid	Brand name	712

Sum of the separately reported names: 2,519. 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 Gemfibrozil, 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	110	105	2	12	71	5	0	37	5
2005	113	104	2	17	68	3	0	34	9
2006	83	70	3	9	46	3	0	30	13
2007	51	45	4	9	30	2	0	15	6
2008	92	73	12	13	41	6	0	15	19
2009	121	104	25	15	46	4	0	36	17
2010	66	57	13	7	30	5	1	22	9
2011	97	83	26	10	34	3	0	22	14
2012	78	64	14	6	29	1	0	27	14
2013	110	93	14	2	37	6	0	59	17
2014	74	51	29	1	8	0	0	17	23
2015	85	55	1	3	23	3	0	35	30
2016	72	40	2	0	18	2	0	28	32
2017	63	44	7	1	22	4	0	31	19
2018	94	57	11	6	32	1	0	42	37
2019	120	71	10	9	26	2	2	62	49
2020	64	51	6	2	27	2	0	33	13
2021	63	48	4	5	23	1	0	36	15
2022	55	47	8	1	9	1	0	41	8
2023	54	39	6	1	16	0	0	28	15
2024	60	56	12	3	32	1	0	38	4
2025	54	47	11	0	19	0	0	37	7
2026	28	23	12	1	4	0	0	14	5

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 Gemfibrozil, 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 Gemfibrozil, by the year in which FDA received them
Year	Reports
2004	102
2005	116
2006	84
2007	52
2008	82
2009	131
2010	65
2011	96
2012	100
2013	102
2014	78
2015	89
2016	75
2017	62
2018	111
2019	122
2020	57
2021	54
2022	51
2023	54
2024	67
2025	38
2026	19

Reports that name Gemfibrozil, 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 Gemfibrozil
Age	Reports	Share
Under 2	5	0.3%
2 to 11	17	0.9%
12 to 17	6	0.3%
18 to 44	237	13.1%
45 to 64	588	32.5%
65 to 74	333	18.4%
75 and over	191	10.6%
Age not given	430	23.8%

Sex of the patient in the reports that name Gemfibrozil
Sex	Reports	Share
Female	623	34.5%
Male	972	53.8%
Unknown or not given	212	11.7%

Type of reporter in the reports that name Gemfibrozil
Reporter	Reports	Share
Physician	467	25.8%
Pharmacist	439	24.3%
Other health professional	460	25.5%
Lawyer	4	0.2%
Consumer or non-health professional	312	17.3%
Not given	125	6.9%

Age and sex are as the report gives them. The reporter is the primary source in the report. 68.1% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Gemfibrozil record
Indication as recorded (MedDRA)	Reports	Share
Hyperlipidaemia	243	13.4%
Hypertriglyceridaemia	162	9%
Hypercholesterolaemia	83	4.6%
Blood cholesterol increased	61	3.4%
Blood triglycerides increased	55	3%
Dyslipidaemia	49	2.7%

The reporter fills in the indication, and the field is often empty. Each share is of all 1,807 reports.

Pages near this one

Lopid same ingredient
Fenofibrate same class
Actos same class
Pioglitazone same class
Pioglitazone hydrochloride same class
Gemcitabine/Gemcitabine Hydrochloride next in the A to Z list
Gemtesa next in the A to Z list
Gemcitabine hydrochloride next in the A to Z list
Gemtuzumab ozogamicin next in the A to Z list
Gemcitabine hcl next in the A to Z list
Gemzar next in the A to Z list
Gemcitabine 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 GemfibrozilThe 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. Gemfibrozil: adverse event reports that FDA received. https://reportedreactions.com/drug/gemfibrozil/ 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 Gemfibrozil as a suspect or interacting product. The 9,645 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 Gemfibrozil 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 Gemfibrozil?

No. It is a count of what people reported to FDA: 1,807 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?

Physician (25.8%), other health professional (25.5%) and pharmacist (24.3%). 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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