Sulfatrim (sulfamethoxazole and trimethoprim) adverse event reports that FDA received

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

Name type: Brand name
Generic name: Sulfamethoxazole and trimethoprim
Class: Dihydrofolate reductase inhibitor antibacterial
Also reported as: Sulfatrim /00086101/

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 576 adverse event reports that name Sulfatrim. In these reports the drug is a suspect or interacting product.

In the same period, 2,085 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 120 reports in the 12 months to June 2026 and 83 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 Sulfatrim 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 38 reports that name Sulfatrim.
In January to March 2026, FDA received 19.
In April to June 2025, FDA received 14.

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 308 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 520 of the 576 reports (90.3%).

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 308 terms.

Reaction terms in the reports that name Sulfatrim, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 576 reports
Dyspnoeashortness of breath	143	24.8%
Off label useused for a purpose or in a way not on the label	132	22.9%
Drug ineffectivethe medicine did not work as expected	119	20.7%
Infectionan infection, type not specified	118	20.5%
Condition aggravatedthe condition being treated got worse	112	19.4%
Pemphigus	108	18.8%
Gastrooesophageal reflux diseaseacid reflux	106	18.4%
Infusion related reactiona reaction during or soon after an infusion	104	18.1%
Nauseafeeling sick	104	18.1%
Pulmonary fibrosis	103	17.9%
Glossodynia	99	17.2%
Somnolencedrowsiness	99	17.2%
Rheumatoid arthritisrheumatoid arthritis, an inflammatory joint disease	97	16.8%
Coma	96	16.7%
Pneumonia aspirationlung infection from breathing in material	96	16.7%
Wheezing	94	16.3%
Systemic lupus erythematosuslupus, an autoimmune disease	93	16.1%
Hand deformity	92	16%
Pyrexiafever	91	15.8%
Synovitis	89	15.5%
Lung disordera lung problem, type not specified	88	15.3%
Painpain, site not specified	88	15.3%
Arthropathy	87	15.1%
Drug hypersensitivityan allergic-type reaction (the term names a medicine)	86	14.9%
Hepatic enzyme increasedraised liver enzymes	86	14.9%
Wound	86	14.9%
Drug intolerancethe medicine was not tolerated	85	14.8%
Lower respiratory tract infectiona chest infection	84	14.6%
Discomfort	83	14.4%
Fatiguetiredness	82	14.2%
Oedemaswelling from fluid	81	14.1%
Anti-cyclic citrullinated peptide antibody positive	80	13.9%
Contusiona bruise	80	13.9%
Arthralgiajoint pain	79	13.7%
Decreased appetitereduced appetite	77	13.4%
Pain in extremitypain in an arm or leg	77	13.4%
Weight decreasedweight loss	77	13.4%
Joint swellinga swollen joint	76	13.2%
Lower limb fracture	76	13.2%
Pericarditisinflammation of the sac around the heart	75	13%
Gastrointestinal disorder	74	12.8%
Injurya physical injury	74	12.8%
Alopeciahair loss	73	12.7%
Asthma	73	12.7%
Rashskin rash	73	12.7%
Rheumatoid factor positive	73	12.7%
Helicobacter infection	71	12.3%
Nasopharyngitisa cold	71	12.3%
Anxiety	70	12.2%
Dislocation of vertebra	70	12.2%

Download all 308 terms of Sulfatrim (CSV)

The counts add to more than 576 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 Sulfamethoxazole and trimethoprim with a page, in the order generic names, brand names, names as reported
Name	Name type	Reports
Sulfamethoxazole and trimethoprim	Generic name	9,070
Sulfamethoxazole, trimethoprim	Generic name	9,960
Bactrim	Brand name	16,598
Bactrim DS	Brand name	1,550
Sulfatrim (this page)	Brand name	576

Sum of the separately reported names: 37,754. 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 Sulfatrim, 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	2	2	0	1	1	0	0	1	0
2005	0	0	0	0	0	0	0	0	0
2007	0	0	0	0	0	0	0	0	0
2008	2	0	0	0	0	0	0	0	2
2009	4	4	0	0	4	0	0	1	0
2010	13	13	1	2	8	2	0	2	0
2011	22	22	2	2	12	0	0	12	0
2012	2	2	0	2	2	1	0	0	0
2013	1	1	0	0	0	0	0	1	0
2014	3	1	0	0	1	0	0	1	2
2015	11	10	0	2	4	0	0	8	1
2016	10	9	0	0	6	0	0	4	1
2017	11	10	0	0	4	0	0	8	1
2018	10	8	1	0	5	0	0	5	2
2019	35	35	0	1	31	0	0	21	0
2020	45	45	3	3	32	0	0	28	0
2021	30	30	2	2	27	0	0	19	0
2022	37	37	1	5	29	3	0	29	0
2023	43	42	2	6	28	1	0	34	1
2024	66	66	15	21	36	19	3	65	0
2025	114	113	61	72	87	50	20	104	1
2026	115	115	93	82	89	71	59	108	0

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 Sulfatrim, 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 Sulfatrim, by the year in which FDA received them
Year	Reports
2004	2
2008	2
2009	4
2010	13
2011	22
2012	3
2013	3
2014	7
2015	16
2016	15
2017	15
2018	17
2019	53
2020	58
2021	35
2022	27
2023	54
2024	76
2025	97
2026	57

Reports that name Sulfatrim, 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 Sulfatrim
Age	Reports	Share
Under 2	11	1.9%
2 to 11	19	3.3%
12 to 17	12	2.1%
18 to 44	148	25.7%
45 to 64	150	26%
65 to 74	79	13.7%
75 and over	38	6.6%
Age not given	119	20.7%

Sex of the patient in the reports that name Sulfatrim
Sex	Reports	Share
Female	365	63.4%
Male	121	21%
Unknown or not given	90	15.6%

Type of reporter in the reports that name Sulfatrim
Reporter	Reports	Share
Physician	64	11.1%
Pharmacist	38	6.6%
Other health professional	380	66%
Lawyer	0	0%
Consumer or non-health professional	83	14.4%
Not given	11	1.9%

Age and sex are as the report gives them. The reporter is the primary source in the report. 4.9% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Sulfatrim record
Indication as recorded (MedDRA)	Reports	Share
Urinary tract infection	18	3.1%
Rheumatoid arthritis	16	2.8%
Pneumocystis jiroveci pneumonia	9	1.6%
Antifungal prophylaxis	7	1.2%
Stomatitis	4	0.7%
Antibiotic therapy	3	0.5%

The reporter fills in the indication, and the field is often empty. Each share is of all 576 reports.

Pages near this one

Sulfamethoxazole and trimethoprim same ingredient
Sulfamethoxazole, trimethoprim same ingredient
Bactrim same ingredient
Bactrim DS same ingredient
Trimethoprim same class
Sulfathiazole next in the A to Z list
Sulfisomidine next in the A to Z list
Sulfathalidine next in the A to Z list
Sulfur next in the A to Z list
Sulfasalazine next in the A to Z list
Sulfur hexafluoride next in the A to Z list
Sulfamethoxazole-Trimethoprim 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 SulfatrimThe 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. Sulfatrim: adverse event reports that FDA received. https://reportedreactions.com/drug/sulfatrim/ 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 Sulfatrim as a suspect or interacting product. The 2,085 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 Sulfatrim 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 Sulfatrim?

No. It is a count of what people reported to FDA: 576 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 (66%), consumer or non-health professional (14.4%) and physician (11.1%). 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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