Pet Drug Reports

Sulfadimethoxine (Bactrovet, Albon): adverse event reports that FDA received

Active ingredient

Also sold as: Bactrovet, Albon, Medacide-SDM Injection 10%, Agribon Concentrated Solution 12.5%, DI-METHOX, Sulfasol, and 3 more brand names.

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

From March 1991 to June 2026, FDA received 1,705 adverse event reports that name a drug with sulfadimethoxine as its active ingredient. Of the 1,705 reports, 918 (53.8%) are about dogs. 322 reports are about cats (18.9%).

In January to March 2026, FDA received 13 reports that name this drug. The signs that appear in the largest number of the 1,705 reports are "Lack of efficacy (protozoa) - Coccidia", "Vomiting" and "Diarrhoea". A report is not proof that a drug caused a sign.

Reports that name this drug rose by 90.9% 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 53.8% of the reports that name this drug, and 72.6% of all reports.

Since the last update of the FDA data

The latest update of the FDA data, recorded on , changed no count of this page.

January to March 2026 is the latest closed quarter in the data. In that quarter FDA received 13 reports that name sulfadimethoxine: 11 dog, 1 cat, 0 horse, 1 other or not given.

All updatesFeed of updates (RSS)

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 1,705 reports that list the sign. One report can list more than one sign.

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

  1. Lack of efficacy (protozoa) - Coccidia[the product did not have the expected effect: coccidia]17.6%300 reports
  2. Vomiting12.8%219 reports
  3. Diarrhoea[diarrhea]10.2%174 reports
  4. Death8.6%146 reports
  5. Depression[dull, quiet or withdrawn]6.7%114 reports
  6. Lethargy[unusually tired or inactive]6.7%114 reports
  7. Anorexia[not eating]5.5%94 reports
  8. Fever4.4%75 reports
  9. Vials, Leaking[a product quality report, not a sign in an animal]4.3%73 reports
  10. Anaemia NOS[low red blood cell count]3.8%65 reports
  11. Bolus, Abnormal3.5%60 reports
  12. No sign[no clinical sign was reported]3.4%58 reports
  13. Ataxia[unsteady, uncoordinated movement]3.2%54 reports
  14. Death by euthanasia[the animal was euthanized]3.1%53 reports
Show the next 16 signs
  1. Other abnormal test result NOS[abnormal laboratory result, type not specified]2.6%45 reports
  2. Containers, Damaged[a product quality report, not a sign in an animal]2.6%44 reports
  3. Accidental exposure[exposure that was not intended]2.3%40 reports
  4. Convulsion[seizure]2.2%38 reports
  5. Pruritus[itching]2.2%38 reports
  6. Dehydration2.2%37 reports
  7. Facial oedema[swollen face]2.2%37 reports
  8. Weakness2.2%37 reports
  9. Vials, Damaged[a product quality report, not a sign in an animal]2.1%36 reports
  10. Seal, Abnormal[a product quality report, not a sign in an animal]2.1%35 reports
  11. Emesis[vomiting]2%34 reports
  12. Leucocytosis NOS[high white blood cell count]2%34 reports
  13. Caps, Abnormal[a product quality report, not a sign in an animal]1.9%32 reports
  14. Uncoded sign[a sign with no matching dictionary term]1.8%31 reports
  15. Weight loss1.8%31 reports
  16. Bloody diarrhoea[diarrhea with blood]1.8%30 reports

The list shows 30 of 739 coded signs. A report is not proof that a drug caused a sign. Download all signs (CSV)

Reports by species

The share is of all 1,705 reports that name sulfadimethoxine. The other reports give a different species or no species.

Reports for each month, Jul 2021 to Jun 2026

Dog125 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 given28 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
20262330531
202531110850
20242770842
20231770327
20221740324
202121100435
202030801351
20192570638
201818201333
20174490760
20164250754
201527801348
201429601045
2013411101365
201245901266
201130801957
201032903172
2009281102968
2008271102361
2007481902289
2006511511885
2005311302165
2004352401776
2003301501459
20022670740
2001321102770
2000322004496
1999211402257
1998151503666
19971540221
199625110137
199533039
199403036
199301001
199101001

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/Normal8.5%145
  • Recovered with Sequela[recovered, with a lasting effect]0.5%8
  • Ongoing12.3%210
  • Died11.4%194
  • Euthanized1.2%20
  • Outcome Unknown8.9%151

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 1,705 reports that name sulfadimethoxine.

A report about more than one animal can have more than one outcome.

Kind of report

  • Safety issue70.6%1,203
  • Lack of expected effectiveness4.6%79
  • Both safety and lack of expected effectiveness3.7%63
  • Manufacturing or product defect21.1%360
  • Other0%0

571 reports say if the event was serious. 38.4% of them have the serious flag. The person who sends the report sets the flag.

Show age, weight, breed and route

Age of the animal

  • Under 1 year50.3%858
  • 1 to 3 years9%154
  • 4 to 7 years4.9%83
  • 8 to 11 years2.1%36
  • 12 years and over1.8%30
  • Age not given31.9%544

Weight of the animal

  • Under 5 kg (11 lb)34.8%593
  • 5 to 9.9 kg (11 to 22 lb)11.5%196
  • 10 to 24.9 kg (22 to 55 lb)8.4%143
  • 25 to 44.9 kg (55 to 99 lb)4.9%84
  • 45 kg and over (99 lb and over)3.2%54
  • Weight not given37.2%635

Breed, where the report gives one breed

A breed with many animals has many reports.

Route in the report

  • Oral71.9%1,226
  • Intravenous0.6%11
  • Subcutaneous0.4%7
  • Topical0.3%5
  • Intramuscular0.1%2
  • Nasal0.1%1

Each bar is on a scale of 0 to 100%.

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%
  • Agribon Concentrated Solution 12.5%
  • DI-METHOX
  • Sulfasol
  • Sulforal
  • Sulfamed-G
  • SulfaMed

What the Green Book records give

Applications with an approval in force
22
Approved species
Cattle, Chickens, Turkeys, Dogs, Cats, Equids
Dose forms
Liquid (Solution), Soluble Powder, Liquid, Solution, Tablet, Bolus, Injection, Liquid (Suspension), Sustained Release Bolus
Routes
Oral, Intravenous, Subcutaneous, Intramuscular
Sale
RX (prescription)
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
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
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

Other pages with this ingredient

A report names a drug by its set of active ingredients. Each set has its own page. The list is in order of name.

Next in the A to Z list

All drugs by active ingredient. Brand names A to Z

FDA pages for this drug

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

Cite this page

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

Embed this card on your site

Copy this code into your page. The card shows the figures above with their source. A line under the card links to this page.

How embedding works. It is free. Keep the link in the card and the link line under it.

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. The site does not use the application number that a record has.

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 the brand names with this active ingredient.

Do the reports show that the drug caused the signs?

No. 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 63 reports in the 12 months to June 2026. It received 33 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 1,705 reports received from March 1991 to June 2026, 70.6% are about a safety issue only. 8.3% are about a lack of expected effectiveness, alone or with a safety issue. 21.1% are about a defect of the product or its package.