Chloramphenicol adverse event reports that FDA received

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

Name type: Generic name

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 February 2004 to June 2026, FDA received 569 adverse event reports that name Chloramphenicol. In these reports the drug is a suspect or interacting product.

In the same period, 1,661 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 37 reports in the 12 months to June 2026 and 29 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 Chloramphenicol 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 6 reports that name Chloramphenicol.
In January to March 2026, FDA received 16.
In April to June 2025, FDA received 12.

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 187 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 521 of the 569 reports (91.6%).

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 187 terms.

Reaction terms in the reports that name Chloramphenicol, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 569 reports
Off label useused for a purpose or in a way not on the label	110	19.3%
Drug ineffectivethe medicine did not work as expected	109	19.2%
Multiple organ dysfunction syndromeseveral organs failing	97	17%
Vomitingbeing sick	94	16.5%
Sepsisa severe body-wide response to infection	92	16.2%
Condition aggravatedthe condition being treated got worse	89	15.6%
Abdominal painstomach or belly pain	88	15.5%
General physical health deteriorationgeneral decline in health	87	15.3%
Hyponatraemialow blood sodium	86	15.1%
Stress	83	14.6%
Drug hypersensitivityan allergic-type reaction (the term names a medicine)	81	14.2%
Abdominal distensiona bloated abdomen	80	14.1%
Somnolencedrowsiness	78	13.7%
Nauseafeeling sick	77	13.5%
Swelling	74	13%
Ascitesfluid in the abdomen	73	12.8%
Myasthenia gravis	73	12.8%
Appendicitis	72	12.7%
Cardiogenic shockshock from the heart failing to pump	72	12.7%
Constipation	71	12.5%
Incorrect route of product administrationthe product was given by the wrong route	71	12.5%
Sleep disordera sleep problem	71	12.5%
Ventricular fibrillationa chaotic rhythm from the lower heart chambers	71	12.5%
Anaemialow red blood cells	70	12.3%
Appendicolith	70	12.3%
Diabetes mellitusdiabetes	67	11.8%
Thrombosis	67	11.8%
Drug intolerancethe medicine was not tolerated	66	11.6%
Hyperphosphataemia	66	11.6%
Pulmonary embolisma blood clot in the lung	66	11.6%
Chronic obstructive pulmonary diseaseCOPD, a long-term lung disease	65	11.4%
Hypophosphataemia	65	11.4%
Intentional product misusedeliberate use not as intended	65	11.4%
Neuralgia	65	11.4%
Bacterial infectiona bacterial infection	62	10.9%
Product use in unapproved indicationused for a purpose not on the label	61	10.7%
Dry mouth	59	10.4%
Activated partial thromboplastin time prolonged	58	10.2%
Dyspnoeashortness of breath	58	10.2%
Blood cholesterol increasedraised cholesterol	57	10%
Lower respiratory tract infectiona chest infection	57	10%
Blood phosphorus increased	55	9.7%
Blood uric acid increasedraised uric acid	54	9.5%
Analgesic therapy	50	8.8%
Drug therapy	49	8.6%
Gout	49	8.6%
Hypertensionhigh blood pressure	49	8.6%
Sleep disorder therapy	48	8.4%
Ulcer	48	8.4%
End stage renal diseasekidney failure needing dialysis or transplant	47	8.3%

Download all 187 terms of Chloramphenicol (CSV)

The counts add to more than 569 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 Chloramphenicol, 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	8	7	1	1	2	3	0	1	1
2005	4	4	1	1	2	0	0	2	0
2006	21	17	2	1	0	0	0	14	4
2007	9	9	2	0	4	1	0	4	0
2008	13	13	1	0	1	0	0	12	0
2009	10	10	1	0	2	1	0	8	0
2010	6	5	0	0	2	0	0	3	1
2011	12	12	0	1	3	0	0	9	0
2012	17	17	1	0	2	0	0	14	0
2013	28	28	12	1	7	0	0	18	0
2014	13	12	1	0	6	4	0	5	1
2015	11	10	3	1	3	3	0	4	1
2016	33	33	8	3	6	1	1	26	0
2017	18	17	5	4	8	0	0	12	1
2018	19	19	3	0	6	1	0	12	0
2019	35	35	2	3	18	1	0	26	0
2020	42	40	3	2	9	0	0	37	2
2021	35	32	1	0	2	0	0	32	3
2022	61	55	23	2	17	11	0	39	6
2023	57	57	45	33	43	37	1	52	0
2024	42	41	15	14	27	16	4	34	1
2025	36	36	24	21	26	26	19	32	0
2026	39	38	34	33	34	32	27	37	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 Chloramphenicol, 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 Chloramphenicol, by the year in which FDA received them
Year	Reports
2004	8
2005	4
2006	21
2007	9
2008	15
2009	10
2010	5
2011	12
2012	20
2013	30
2014	11
2015	14
2016	38
2017	15
2018	19
2019	52
2020	46
2021	36
2022	58
2023	63
2024	32
2025	29
2026	22

Reports that name Chloramphenicol, 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 Chloramphenicol
Age	Reports	Share
Under 2	12	2.1%
2 to 11	19	3.3%
12 to 17	17	3%
18 to 44	130	22.8%
45 to 64	68	12%
65 to 74	71	12.5%
75 and over	164	28.8%
Age not given	88	15.5%

Sex of the patient in the reports that name Chloramphenicol
Sex	Reports	Share
Female	225	39.5%
Male	292	51.3%
Unknown or not given	52	9.1%

Type of reporter in the reports that name Chloramphenicol
Reporter	Reports	Share
Physician	124	21.8%
Pharmacist	22	3.9%
Other health professional	347	61%
Lawyer	0	0%
Consumer or non-health professional	38	6.7%
Not given	38	6.7%

Age and sex are as the report gives them. The reporter is the primary source in the report. 11.4% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Chloramphenicol record
Indication as recorded (MedDRA)	Reports	Share
Bacterial infection	32	5.6%
Antibiotic therapy	10	1.8%
Cataract operation	8	1.4%
Eye infection staphylococcal	7	1.2%
Conjunctivitis	6	1.1%
Keratitis	6	1.1%

The reporter fills in the indication, and the field is often empty. Each share is of all 569 reports.

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These links are for navigation. No count selected them.

Official pages

DailyMed labels for ChloramphenicolThe 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. Chloramphenicol: adverse event reports that FDA received. https://reportedreactions.com/drug/chloramphenicol/ 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 Chloramphenicol as a suspect or interacting product. The 1,661 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 Chloramphenicol 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 Chloramphenicol?

No. It is a count of what people reported to FDA: 569 reports from February 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 (61%), physician (21.8%) and consumer or non-health professional (6.7%). 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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