Pet Drug Reports

Sulfadimethoxine: adverse event reports in all combinations

Active ingredient, alone and in combinations

Brand names with this ingredient: Bactrovet, Albon, Medacide-SDM Injection 10%, Primor, Agribon Concentrated Solution 12.5%, Rofenaid 40, and 6 more.

The openFDA records give the value "MSK" for the brand name and for the manufacturer name of each drug. FDA says that MSK means "masked". So the site cannot count a report for a brand.

Read this first. FDA says this about the data:

An API dataset query result cannot be used to estimate the risk associated with the product or compare one drug or device product with another. When looking at the results, be aware that there is no certainty that the reported drug or device caused the adverse event. This dataset should not be the sole source of information for clinical decision-making or other assumptions about the safety or effectiveness of a product. The adverse event may have been related to an underlying disease, other drugs used at the same time or other non-drug related sources.

FDA Center for Veterinary Medicine publishes these words. Source: Adverse Event Reports for Animal Drugs and Devices, read on . The data have the reports that FDA received through .

This page is not veterinary advice. For an animal that is ill, speak to a veterinarian.

Contacting a veterinarianHow to report to FDA

FDA reports received through . Counts include this ingredient alone and in combinations. Why brand names have no separate count.

From January 1990 to June 2026, FDA received 2,849 adverse event reports that name a drug with sulfadimethoxine, alone or in a combination. 2 sets of active ingredients with sulfadimethoxine have a drug page.

Of the 2,849 reports, 1,966 (69%) are about dogs. 363 reports are about cats (12.7%). In January to March 2026, FDA received 13 reports that name sulfadimethoxine, alone or in a combination. The signs that appear in the largest number of the 2,849 reports are "Vomiting", "Lack of efficacy (protozoa) - Coccidia" and "Depression". A report is not proof that a drug caused a sign.

Reports that name this ingredient rose by 91.2% in the 12 months to June 2026, compared with the 12 months before. Reports for all animal drugs fell by 4.6% in the same periods. The newest months can get more reports in a later update. Reports about dogs are 69% of the reports that name this ingredient, and 72.6% of all reports.

Reports in the latest closed quarter

Reports that name sulfadimethoxine, by the quarter in which FDA received them
SpeciesJan to Mar 2026Oct to Dec 2025Jan to Mar 2025
All species132011
Dog11126
Cat154
Horse000
Other or not given131

January to March 2026 is the latest closed quarter in the data.

All updatesFeed of updates (RSS)

Drug pages with sulfadimethoxine

A report names a drug by its set of active ingredients. Each set with sulfadimethoxine that has a drug page is in the table, in order of name. The table has 2 sets.

Drug pages with sulfadimethoxine, in order of name, with the reports of each page
Active ingredientsReports, all yearsReports, latest 12 months
Ormetoprim + Sulfadimethoxine1,1472
Sulfadimethoxine1,70563

A report can name more than one set, so the counts of the sets can add to more than the count of the page.

An API dataset query result cannot be used to estimate the risk associated with the product or compare one drug or device product with another.

FDA Center for Veterinary Medicine. Source: Adverse Event Reports for Animal Drugs and Devices

Signs that the reports list

A sign is a coded term from the report. The words in brackets are a plain gloss of the term. The percentage is the share of the 2,849 reports that list the sign. One report can list more than one sign and more than one drug.

The sign that is in the largest number of the reports comes first.

  1. Vomiting12.1%345 reports
  2. Lack of efficacy (protozoa) - Coccidia[the product did not have the expected effect: coccidia]10.9%310 reports
  3. Depression[dull, quiet or withdrawn]9.6%273 reports
  4. Anorexia[not eating]8%229 reports
  5. Death7.7%220 reports
  6. Diarrhoea[diarrhea]7.5%213 reports
  7. Fever6.9%197 reports
  8. Ataxia[unsteady, uncoordinated movement]6%171 reports
  9. Lethargy[unusually tired or inactive]5.3%150 reports
  10. Anaemia NOS[low red blood cell count]4.6%131 reports
  11. Convulsion[seizure]4.5%129 reports
  12. Thrombocytopenia[low platelet count]4.1%117 reports
  13. Elevated alanine aminotransferase (ALT)[a liver enzyme above the normal range]3.9%111 reports
  14. Elevated serum alkaline phosphatase (SAP)[a liver and bone enzyme above the normal range]3.8%109 reports
Show the next 16 signs
  1. Death by euthanasia[the animal was euthanized]3.5%101 reports
  2. No sign[no clinical sign was reported]3.1%89 reports
  3. Behavioural disorder NOS[behaviour change, type not specified]2.8%80 reports
  4. Trembling2.6%75 reports
  5. Leucocytosis NOS[high white blood cell count]2.6%73 reports
  6. Vials, Leaking[a product quality report, not a sign in an animal]2.6%73 reports
  7. Weakness2.6%73 reports
  8. Elevated total bilirubin[bilirubin above the normal range]2.5%72 reports
  9. Weight loss2.4%68 reports
  10. Accidental exposure[exposure that was not intended]2.2%64 reports
  11. Other abnormal test result NOS[abnormal laboratory result, type not specified]2.2%64 reports
  12. Lack of efficacy (bacteria) - NOS[the product did not have the expected effect: target not specified]2.1%61 reports
  13. Bolus, Abnormal2.1%60 reports
  14. Aggression2%58 reports
  15. Elevated blood urea nitrogen (BUN)[a kidney value above the normal range]2%56 reports

Download all signs (CSV)

Reports by species

Reports for each month, Jul 2021 to Jun 2026

Dog134 reports. Largest count in one month: 7 (May 2024)
Cat39 reports

No chart: no month has 5 or more reports.

Horse0 reports

No chart: no month has 5 or more reports.

Other or not given30 reports

No chart: no month has 5 or more reports.

The month is the month in which FDA received the report. Each chart has its own scale. FDA says that a report can take 3 to 6 months to reach the public data. The newest months can get more reports in a later update.

Reports by year

  • Dog
  • Cat
  • Horse
  • Other or not given
Reports that name sulfadimethoxine, by the year in which FDA received them and by species
YearDogCatHorseOther or not givenAll species
20262530533
202531110850
20242870843
20231970329
20222140530
202125100439
202037801560
20193570749
201829301345
201752110871
20165950771
201543801566
201448601165
2013651101389
201274901295
201155802184
2010491113192
2009501403094
2008481202383
20077920024123
20069719122139
20056518022105
20047926018123
2003491501781
20025070966
20017514028117
20008224046152
19999118026135
19989716045158
19976350674
1996971201110
19957660688
1994120607133
199371008
19922000020
19911610219
19901000010

2026 has the reports that FDA received through Jun 2026. Download the years (CSV)

What the reports record

Outcome at the time of the report

  • Recovered/Normal6.5%186
  • Recovered with Sequela[recovered, with a lasting effect]0.3%8
  • Ongoing10.2%292
  • Died10.8%308
  • Euthanized1%28
  • Outcome Unknown6.5%184

An outcome in a report is not proof that the drug caused it. The person who sends the report gives the outcome. Each share is of the 2,849 reports that name sulfadimethoxine.

Kind of report

  • Safety issue80.4%2,290
  • Lack of expected effectiveness3%85
  • Both safety and lack of expected effectiveness2.7%77
  • Manufacturing or product defect13.9%397
  • Other0%0

Age of the animal

  • Under 1 year36.2%1,031
  • 1 to 3 years14.1%401
  • 4 to 7 years12.8%366
  • 8 to 11 years8.8%250
  • 12 years and over4.4%124
  • Age not given23.8%677

Each share of kind and age is of the 2,849 reports that name sulfadimethoxine.

Approved animal drugs with this active ingredient (FDA Green Book)

This section is reference data. It has no report count.

The openFDA records give the value "MSK" for the brand name and for the manufacturer name of each drug. FDA says that MSK means "masked". So the site cannot count a report for a brand.

Brand names

  • Bactrovet
  • Albon
  • Medacide-SDM Injection 10%
  • Primor
  • Agribon Concentrated Solution 12.5%
  • Rofenaid 40
  • Romet-30
  • DI-METHOX
  • Sulfasol
  • Sulforal
  • Sulfamed-G
  • SulfaMed

What the Green Book records give

Applications with an approval in force
25
Approved species
Cattle, Chickens, Turkeys, Dogs, Cats, Chukar Partridges, Ducks, Equids, Fish
Dose forms
Liquid (Solution), Soluble Powder, Liquid, Solution, Tablet, Type A Medicated Article, Bolus, Injection, Liquid (Suspension), Sustained Release Bolus
Routes
Oral, Intravenous, Subcutaneous, Intramuscular
Sale
RX (prescription), VFD (veterinary feed directive)
Earliest approval date in the records

The species, dose forms and routes are the words of the Green Book records for all the applications together. One product can have fewer. The label of a product gives its approved use.

Applications in the Green Book of 2 Nov 2026, pioneer applications (NADA) first
Brand nameActive ingredientsSponsorApproved speciesApplication
Bactrovet Tablets 250 mgSulfadimethoxineIntervet, Inc.Dogs, CatsNADA 012-087
Albon TabletsSulfadimethoxineZoetis Inc.Dogs, CatsNADA 015-102
Agribon Concentrated Solution 12.5%; Albon Concentrated Solution 12.5%SulfadimethoxineZoetis Inc.Cattle, Chickens, TurkeysNADA 031-205
Albon or AgribonSulfadimethoxineZoetis Inc.CattleNADA 031-715
Bactrovet Oral Suspension 12.5%SulfadimethoxineIntervet, Inc.Dogs, CatsNADA 037-700
Rofenaid 40Ormetoprim, SulfadimethoxinePhibro Animal Health Corp.Chickens, TurkeysNADA 040-209
AlbonSulfadimethoxineZoetis Inc.Dogs, Cats, Horses, CattleNADA 041-245
Albon Oral Suspension 5%SulfadimethoxineZoetis Inc.Dogs, CatsNADA 043-785
AlbonSulfadimethoxineZoetis Inc.Cattle, Chickens, TurkeysNADA 046-285
Albon S.R. (Sustained Release)SulfadimethoxineZoetis Inc.CattleNADA 093-107
Medacide-SDM Injection 10%SulfadimethoxineCronus Pharma Specialities India Private Ltd.DogsNADA 098-569
Primor TabletsOrmetoprim, SulfadimethoxineZoetis Inc.DogsNADA 100-929
Romet-30Ormetoprim, SulfadimethoxinePharmaq ASNot in the list of major speciesNADA 125-933
DI-METHOXSulfadimethoxineHuvepharma EOODCattle, Chickens, TurkeysANADA 200-030
DI-METHOXSulfadimethoxineHuvepharma EOODCattle, Chickens, TurkeysANADA 200-031
Di-Methox Injection 40%SulfadimethoxineHuvepharma EOODCattleANADA 200-038
Sulfadimethoxine Concentrated Solution 12.5%SulfadimethoxineCronus Pharma Specialities India Private Ltd.Cattle, Chickens, TurkeysANADA 200-165
Sulfadimethoxine Injection 40%SulfadimethoxineHuvepharma EOODCattleANADA 200-177
Sulfadimethoxine 12.5% Oral SolutionSulfadimethoxineHuvepharma EOODCattle, Chickens, TurkeysANADA 200-192
Sulfasol Soluble PowderSulfadimethoxineDechra Veterinary Products LLCCattle, Chickens, TurkeysANADA 200-238
SulforalSulfadimethoxineDechra Veterinary Products LLCCattle, Chickens, TurkeysANADA 200-251
Sulfadimethoxine Soluble PowderSulfadimethoxinePhibro Animal Health Corp.Cattle, Chickens, TurkeysANADA 200-258
Sulfamed-GSulfadimethoxineBimeda Animal Health Ltd.Cattle, Chickens, TurkeysANADA 200-376
Sulfadimethoxine Soluble PowderSulfadimethoxineFirst Priority, Inc.Cattle, Chickens, TurkeysANADA 200-443
SulfaMedSulfadimethoxineBimeda Animal Health Ltd.CattleANADA 200-523
Bactrovet Injectableapproval withdrawnSulfadimethoxineMallinckrodt Veterinary, Inc.Not in the list of major speciesNADA 012-554
Rofenaid Plus Roxarsoneapproval withdrawnOrmetoprim, Roxarsone, SulfadimethoxineZoetis Inc.ChickensNADA 041-984
Rofenaid & Ipropranapproval withdrawnIpronidazole, Ormetoprim, SulfadimethoxineRoche Vitamins, Inc.Not in the list of major speciesNADA 047-089

FDA pages for this ingredient

The site checked these addresses on . The links open in a new tab.

Cite this page

Pet Drug Reports. Sulfadimethoxine, all combinations: adverse event reports that FDA received. https://petdrugreports.com/ingredient/sulfadimethoxine/ Source: FDA Center for Veterinary Medicine, openFDA Animal and Veterinary adverse event reports, export of . Reports received through .

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Where the data come from

The counts come from the openFDA Animal and Veterinary adverse event files, export of 30 Oct 2026. The files have the reports that the FDA Center for Veterinary Medicine received through 26 Jun 2026. The files mask brand and manufacturer names. The site counts a drug by the active ingredients that each record gives, and gives no count to a brand, an application or a company. Ingredient names and the lists of approved products follow the FDA Green Book of 2 Nov 2026. Ingredient names follow the Green Book, with salts and forms as FDA lists them.

The site does not publish report text, lot numbers or details of a reporter. FDA's record is the authority. See how the site counts reports, the data sources and the corrections page.

Questions about these reports

Which brand are these reports about?

The openFDA records give the value "MSK" for the brand name and for the manufacturer name of each drug. FDA says that MSK means "masked". So the site cannot count a report for a brand. The Green Book section of this page lists brand names with this active ingredient.

Do the reports show that the ingredient caused the signs?

No. A report can name more than one drug, and a drug can have more than one active ingredient. FDA states this about the data.

When looking at the results, be aware that there is no certainty that the reported drug or device caused the adverse event.

The adverse event may have been related to an underlying disease, other drugs used at the same time or other non-drug related sources.

FDA Center for Veterinary Medicine. Source: Adverse Event Reports for Animal Drugs and Devices

How many reports did FDA receive in the latest 12 months?

FDA received 65 reports in the 12 months to June 2026. It received 34 reports in the 12 months before. FDA says that a report can take 3 to 6 months to reach the public data. The newest months can get more reports in a later update.

What kinds of report are in the count?

Of the 2,849 reports received from January 1990 to June 2026, 80.4% are about a safety issue only. 5.7% are about a lack of expected effectiveness, alone or with a safety issue. 13.9% are about a defect of the product or its package.