Rifabutin adverse event reports that FDA received

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

Name type: Generic name
Also reported as: Rifabutin Capsules

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 March 2004 to June 2026, FDA received 1,801 adverse event reports that name Rifabutin. In these reports the drug is a suspect or interacting product.

In the same period, 914 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 214 reports in the 12 months to June 2026 and 290 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 Rifabutin 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 45 reports that name Rifabutin.
In January to March 2026, FDA received 55.
In April to June 2025, FDA received 61.

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 203 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 1,793 of the 1,801 reports (99.6%).

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 203 terms.

Reaction terms in the reports that name Rifabutin, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 1,801 reports
Drug interactionan interaction between medicines	231	12.8%
Drug ineffectivethe medicine did not work as expected	206	11.4%
Off label useused for a purpose or in a way not on the label	142	7.9%
Drug resistance	132	7.3%
Drug intolerancethe medicine was not tolerated	114	6.3%
Pyrexiafever	103	5.7%
Nauseafeeling sick	94	5.2%
Mycobacterium avium complex infection	92	5.1%
Neutropenialow neutrophils, a type of white blood cell	87	4.8%
Treatment failurethe treatment did not work	72	4%
Drug reaction with eosinophilia and systemic symptomsDRESS, a severe reaction with rash, fever and organ involvement	67	3.7%
Immune reconstitution inflammatory syndrome	62	3.4%
Product use in unapproved indicationused for a purpose not on the label	60	3.3%
Condition aggravatedthe condition being treated got worse	59	3.3%
Diarrhoealoose or frequent stools	54	3%
Uveitis	54	3%
Vomitingbeing sick	54	3%
Leukopenialow white blood cells	48	2.7%
Weight decreasedweight loss	48	2.7%
Toxicity to various agentspoisoning or toxic effect of one or more substances	47	2.6%
Fatiguetiredness	44	2.4%
Hepatotoxicityliver injury	44	2.4%
Thrombocytopenialow platelets	40	2.2%
Decreased appetitereduced appetite	39	2.2%
Disease progressionthe disease advanced	37	2.1%
Pneumonialung infection	37	2.1%
Dyspnoeashortness of breath	36	2%
Acute kidney injurysudden loss of kidney function	35	1.9%
Cough	35	1.9%
Headachehead pain	35	1.9%
Drug level decreaseda low blood level of the medicine	34	1.9%
Rashskin rash	34	1.9%
Electrocardiogram QT prolongeda QT prolongation on the ECG	31	1.7%
Mycobacterial infection	30	1.7%
Disseminated mycobacterium avium complex infection	27	1.5%
White blood cell count decreasedlow white cell count	27	1.5%
Astheniaweakness or lack of energy	26	1.4%
Pancytopenialow counts of all blood cells	26	1.4%
Pathogen resistance	26	1.4%
Neuropathy peripheralnerve damage in hands or feet	25	1.4%
Drug ineffective for unapproved indication	24	1.3%
Myalgiamuscle pain	24	1.3%
Hypertransaminasaemia	23	1.3%
Tuberculosis	23	1.3%
Arthralgiajoint pain	22	1.2%
Gastrointestinal disorder	22	1.2%
Malaisegeneral feeling of being unwell	22	1.2%
Renal impairmentreduced kidney function	22	1.2%
Acute hepatic failure	21	1.2%
Anaemialow red blood cells	21	1.2%

Download all 203 terms of Rifabutin (CSV)

The counts add to more than 1,801 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 Rifabutin, 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	15	7	2	0	5	2	0	3	8
2005	14	13	1	1	11	0	0	3	1
2006	14	14	2	1	8	3	0	7	0
2007	6	6	0	0	2	0	0	5	0
2008	14	14	2	0	7	0	0	10	0
2009	34	31	9	1	11	0	0	22	3
2010	32	30	4	4	12	0	0	17	2
2011	27	26	7	2	14	2	0	11	1
2012	36	33	6	6	23	2	1	19	3
2013	24	23	5	0	7	1	0	19	1
2014	15	15	1	0	6	0	0	11	0
2015	43	38	7	1	17	0	0	27	5
2016	46	44	18	2	9	0	0	32	2
2017	55	50	2	0	26	0	0	46	5
2018	121	97	21	2	35	0	0	83	24
2019	75	68	15	2	28	3	0	53	7
2020	95	80	3	0	28	0	0	70	15
2021	116	110	9	10	30	6	0	86	6
2022	144	118	28	10	32	1	0	86	26
2023	210	146	11	10	51	0	0	113	64
2024	250	203	14	11	90	1	0	172	47
2025	302	233	10	6	80	1	0	198	69
2026	113	86	13	7	27	0	0	74	27

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 Rifabutin, 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 Rifabutin, by the year in which FDA received them
Year	Reports
2004	12
2005	17
2006	14
2007	6
2008	12
2009	37
2010	33
2011	27
2012	38
2013	25
2014	16
2015	46
2016	57
2017	52
2018	129
2019	82
2020	97
2021	117
2022	148
2023	213
2024	252
2025	271
2026	100

Reports that name Rifabutin, 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 Rifabutin
Age	Reports	Share
Under 2	1	0.1%
2 to 11	35	1.9%
12 to 17	61	3.4%
18 to 44	358	19.9%
45 to 64	490	27.2%
65 to 74	293	16.3%
75 and over	170	9.4%
Age not given	393	21.8%

Sex of the patient in the reports that name Rifabutin
Sex	Reports	Share
Female	821	45.6%
Male	811	45%
Unknown or not given	169	9.4%

Type of reporter in the reports that name Rifabutin
Reporter	Reports	Share
Physician	724	40.2%
Pharmacist	75	4.2%
Other health professional	814	45.2%
Lawyer	1	0.1%
Consumer or non-health professional	148	8.2%
Not given	39	2.2%

Age and sex are as the report gives them. The reporter is the primary source in the report. 48.8% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Rifabutin record
Indication as recorded (MedDRA)	Reports	Share
Mycobacterium avium complex infection	387	21.5%
Tuberculosis	195	10.8%
Mycobacterial infection	113	6.3%
Atypical mycobacterial infection	73	4.1%
Pulmonary tuberculosis	73	4.1%
Disseminated mycobacterium avium complex infection	46	2.6%

The reporter fills in the indication, and the field is often empty. Each share is of all 1,801 reports.

Drugs in the same reports

Other drugs that the reports of Rifabutin name, in any role, in order of name
Drug	Reports that name the two
Amikacin	294
Azithromycin	465
Clarithromycin	438
Ethambutol	930
Isoniazid	350
Levofloxacin	165
Linezolid	185
Moxifloxacin	252
Pyrazinamide	298
Rifampin	323

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

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Rifampicine next in the A to Z list
Ribavarin next in the A to Z list
Rifampin next in the A to Z list
Ribasphere Ribapak 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 RifabutinThe 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. Rifabutin: adverse event reports that FDA received. https://reportedreactions.com/drug/rifabutin/ 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 Rifabutin as a suspect or interacting product. The 914 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 Rifabutin 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 Rifabutin?

No. It is a count of what people reported to FDA: 1,801 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?

Other health professional (45.2%), physician (40.2%) and consumer or non-health professional (8.2%). 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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