Clofazimine adverse event reports that FDA received

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

Name type: Generic name
Class: Antimycobacterial

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 March 2004 to June 2026, FDA received 4,076 adverse event reports that name Clofazimine. In these reports the drug is a suspect or interacting product.

In the same period, 1,444 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 330 reports in the 12 months to June 2026 and 265 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, 330 (under 0.1%) name Clofazimine. Reports from consumers or other non-health professionals were 11.9% of the reports that name Clofazimine 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 Clofazimine 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 75 reports that name Clofazimine.
In January to March 2026, FDA received 108.
In April to June 2025, FDA received 45.

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 402 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 4,037 of the 4,076 reports (99%).

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 402 terms.

Reaction terms in the reports that name Clofazimine, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 4,076 reports
Electrocardiogram QT prolongeda QT prolongation on the ECG	598	14.7%
Off label useused for a purpose or in a way not on the label	416	10.2%
Vomitingbeing sick	377	9.2%
Anaemialow red blood cells	348	8.5%
Nauseafeeling sick	343	8.4%
Neuropathy peripheralnerve damage in hands or feet	244	6%
Dyspnoeashortness of breath	234	5.7%
Drug ineffectivethe medicine did not work as expected	214	5.3%
Drug resistance	199	4.9%
Hepatotoxicityliver injury	172	4.2%
Product use in unapproved indicationused for a purpose not on the label	172	4.2%
Diarrhoealoose or frequent stools	165	4%
Deaththe patient died; cause not stated by this term	163	4%
Tuberculosis	136	3.3%
Astheniaweakness or lack of energy	135	3.3%
Decreased appetitereduced appetite	134	3.3%
Intentional product use issuedeliberate use not as intended	133	3.3%
Respiratory failurethe lungs could not supply enough oxygen	126	3.1%
Pyrexiafever	125	3.1%
Haemoglobin decreasedlow haemoglobin	123	3%
Treatment failurethe treatment did not work	121	3%
Aspartate aminotransferase increasedraised liver enzyme (AST)	119	2.9%
Drug-induced liver injury	118	2.9%
Cough	117	2.9%
Alanine aminotransferase increasedraised liver enzyme (ALT)	113	2.8%
Weight decreasedweight loss	102	2.5%
Hypokalaemialow blood potassium	98	2.4%
Drug interactionan interaction between medicines	90	2.2%
Pneumonialung infection	87	2.1%
Acute kidney injurysudden loss of kidney function	86	2.1%
Headachehead pain	82	2%
Dizzinesslight-headedness or unsteadiness	79	1.9%
Drug intolerancethe medicine was not tolerated	77	1.9%
Fatiguetiredness	77	1.9%
Arthralgiajoint pain	76	1.9%
Incorrect product administration duration	75	1.8%
Condition aggravatedthe condition being treated got worse	74	1.8%
Mycobacterium avium complex infection	69	1.7%
Rashskin rash	69	1.7%
Abdominal painstomach or belly pain	67	1.6%
Seizurea fit or convulsion	66	1.6%
Skin discolourationa change in skin colour	66	1.6%
Gastrointestinal disorder	65	1.6%
Thrombocytopenialow platelets	65	1.6%
Type 2 lepra reaction	60	1.5%
Disease progressionthe disease advanced	54	1.3%
Product use issuea problem in how the product was used	53	1.3%
Platelet count decreasedlow platelet count	52	1.3%
Ototoxicity	51	1.3%
Hypotensionlow blood pressure	50	1.2%

Download all 402 terms of Clofazimine (CSV)

The counts add to more than 4,076 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 Clofazimine with a page, in the order generic names, brand names, names as reported
Name	Name type	Reports
Clofazimine (this page)	Generic name	4,076
Lamprene	Brand name	775

Sum of the separately reported names: 4,851. 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 Clofazimine, 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	4	4	0	0	2	1	0	3	0
2005	9	9	1	1	5	0	0	4	0
2006	3	2	0	0	0	0	0	2	1
2007	2	2	1	0	0	0	0	1	0
2008	3	3	1	0	0	0	0	3	0
2009	5	5	2	0	2	0	0	3	0
2010	2	2	1	0	2	0	0	1	0
2011	5	5	1	0	0	0	0	5	0
2012	6	6	1	0	1	0	0	5	0
2013	19	19	1	0	13	0	0	14	0
2014	17	16	2	2	10	0	0	8	1
2015	23	19	6	0	5	1	0	15	4
2016	78	78	33	8	26	1	0	40	0
2017	189	187	62	21	78	5	0	103	2
2018	636	630	245	58	240	24	0	436	6
2019	663	652	195	37	264	32	0	485	11
2020	445	412	103	28	149	15	0	319	33
2021	186	173	43	7	54	2	0	121	13
2022	394	367	60	33	135	13	0	262	27
2023	492	355	55	18	119	5	0	271	137
2024	356	293	49	26	97	3	7	223	63
2025	330	278	48	20	87	5	7	216	52
2026	209	186	54	13	45	1	12	143	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 Clofazimine, 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 Clofazimine, by the year in which FDA received them
Year	Reports
2004	5
2005	7
2006	5
2007	2
2008	5
2009	7
2010	7
2011	6
2012	7
2013	21
2014	17
2015	25
2016	117
2017	218
2018	737
2019	686
2020	368
2021	189
2022	344
2023	502
2024	337
2025	279
2026	183

Reports that name Clofazimine, 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 Clofazimine
Age	Reports	Share
Under 2	19	0.5%
2 to 11	115	2.8%
12 to 17	89	2.2%
18 to 44	1,560	38.3%
45 to 64	946	23.2%
65 to 74	265	6.5%
75 and over	160	3.9%
Age not given	922	22.6%

Sex of the patient in the reports that name Clofazimine
Sex	Reports	Share
Female	1,703	41.8%
Male	1,940	47.6%
Unknown or not given	433	10.6%

Type of reporter in the reports that name Clofazimine
Reporter	Reports	Share
Physician	2,026	49.7%
Pharmacist	70	1.7%
Other health professional	1,463	35.9%
Lawyer	0	0%
Consumer or non-health professional	485	11.9%
Not given	32	0.8%

Age and sex are as the report gives them. The reporter is the primary source in the report. 24.5% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Clofazimine record
Indication as recorded (MedDRA)	Reports	Share
Tuberculosis	1,922	47.2%
Pulmonary tuberculosis	437	10.7%
Mycobacterium abscessus infection	241	5.9%
Mycobacterium avium complex infection	223	5.5%
Mycobacterial infection	83	2%
Lepromatous leprosy	61	1.5%

The reporter fills in the indication, and the field is often empty. Each share is of all 4,076 reports.

Drugs in the same reports

Other drugs that the reports of Clofazimine name, in any role, in order of name
Drug	Reports that name the two
Amikacin	685
Bedaquiline	1,604
Cycloserine	981
Ethambutol	660
Levofloxacin	951
Linezolid	2,454
Moxifloxacin	888
Pyrazinamide	1,011
Pyridoxine	598
Sirturo	688

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.

Pages near this one

Lamprene same ingredient
Ethambutol hydrochloride same class
Isoniazid same class
Clofarabine next in the A to Z list
Clolar next in the A to Z list
Clobex next in the A to Z list
Clomid next in the A to Z list
Clobetasol propionate next in the A to Z list
Clomiphene citrate next in the A to Z list
Clobetasol next in the A to Z list
Clomipramine next in the A to Z list
Clobazam 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 ClofazimineThe 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. Clofazimine: adverse event reports that FDA received. https://reportedreactions.com/drug/clofazimine/ 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 Clofazimine as a suspect or interacting product. The 1,444 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 Clofazimine 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 Clofazimine?

No. It is a count of what people reported to FDA: 4,076 reports from March 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 (49.7%), other health professional (35.9%) and consumer or non-health professional (11.9%). 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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