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 FDAFrom 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.
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.
- Lack of efficacy (protozoa) - Coccidia[the product did not have the expected effect: coccidia]17.6%300 reports
- Vomiting12.8%219 reports
- Diarrhoea[diarrhea]10.2%174 reports
- Death8.6%146 reports
- Depression[dull, quiet or withdrawn]6.7%114 reports
- Lethargy[unusually tired or inactive]6.7%114 reports
- Anorexia[not eating]5.5%94 reports
- Fever4.4%75 reports
- Vials, Leaking[a product quality report, not a sign in an animal]4.3%73 reports
- Anaemia NOS[low red blood cell count]3.8%65 reports
- Bolus, Abnormal3.5%60 reports
- No sign[no clinical sign was reported]3.4%58 reports
- Ataxia[unsteady, uncoordinated movement]3.2%54 reports
- Death by euthanasia[the animal was euthanized]3.1%53 reports
Show the next 16 signs
- Other abnormal test result NOS[abnormal laboratory result, type not specified]2.6%45 reports
- Containers, Damaged[a product quality report, not a sign in an animal]2.6%44 reports
- Accidental exposure[exposure that was not intended]2.3%40 reports
- Convulsion[seizure]2.2%38 reports
- Pruritus[itching]2.2%38 reports
- Dehydration2.2%37 reports
- Facial oedema[swollen face]2.2%37 reports
- Weakness2.2%37 reports
- Vials, Damaged[a product quality report, not a sign in an animal]2.1%36 reports
- Seal, Abnormal[a product quality report, not a sign in an animal]2.1%35 reports
- Emesis[vomiting]2%34 reports
- Leucocytosis NOS[high white blood cell count]2%34 reports
- Caps, Abnormal[a product quality report, not a sign in an animal]1.9%32 reports
- Uncoded sign[a sign with no matching dictionary term]1.8%31 reports
- Weight loss1.8%31 reports
- 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
No chart: no month has 5 or more reports.
No chart: no month has 5 or more 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
| Year | Dog | Cat | Horse | Other or not given | All species |
|---|---|---|---|---|---|
| 2026 | 23 | 3 | 0 | 5 | 31 |
| 2025 | 31 | 11 | 0 | 8 | 50 |
| 2024 | 27 | 7 | 0 | 8 | 42 |
| 2023 | 17 | 7 | 0 | 3 | 27 |
| 2022 | 17 | 4 | 0 | 3 | 24 |
| 2021 | 21 | 10 | 0 | 4 | 35 |
| 2020 | 30 | 8 | 0 | 13 | 51 |
| 2019 | 25 | 7 | 0 | 6 | 38 |
| 2018 | 18 | 2 | 0 | 13 | 33 |
| 2017 | 44 | 9 | 0 | 7 | 60 |
| 2016 | 42 | 5 | 0 | 7 | 54 |
| 2015 | 27 | 8 | 0 | 13 | 48 |
| 2014 | 29 | 6 | 0 | 10 | 45 |
| 2013 | 41 | 11 | 0 | 13 | 65 |
| 2012 | 45 | 9 | 0 | 12 | 66 |
| 2011 | 30 | 8 | 0 | 19 | 57 |
| 2010 | 32 | 9 | 0 | 31 | 72 |
| 2009 | 28 | 11 | 0 | 29 | 68 |
| 2008 | 27 | 11 | 0 | 23 | 61 |
| 2007 | 48 | 19 | 0 | 22 | 89 |
| 2006 | 51 | 15 | 1 | 18 | 85 |
| 2005 | 31 | 13 | 0 | 21 | 65 |
| 2004 | 35 | 24 | 0 | 17 | 76 |
| 2003 | 30 | 15 | 0 | 14 | 59 |
| 2002 | 26 | 7 | 0 | 7 | 40 |
| 2001 | 32 | 11 | 0 | 27 | 70 |
| 2000 | 32 | 20 | 0 | 44 | 96 |
| 1999 | 21 | 14 | 0 | 22 | 57 |
| 1998 | 15 | 15 | 0 | 36 | 66 |
| 1997 | 15 | 4 | 0 | 2 | 21 |
| 1996 | 25 | 11 | 0 | 1 | 37 |
| 1995 | 3 | 3 | 0 | 3 | 9 |
| 1994 | 0 | 3 | 0 | 3 | 6 |
| 1993 | 0 | 1 | 0 | 0 | 1 |
| 1991 | 0 | 1 | 0 | 0 | 1 |
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
- Domestic9.4%160
- Labrador Retriever4.8%81
- Domestic Shorthair3%51
- Golden Retriever2.9%50
- German Shepherd Dog2.2%37
- Chihuahua2%34
- Yorkshire Terrier1.9%33
- Holstein-Friesian1.8%30
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.
| Brand name | Active ingredients | Sponsor | Approved species | Application |
|---|---|---|---|---|
| Bactrovet Tablets 250 mg | Sulfadimethoxine | Intervet, Inc. | Dogs, Cats | NADA 012-087 |
| Albon Tablets | Sulfadimethoxine | Zoetis Inc. | Dogs, Cats | NADA 015-102 |
| Agribon Concentrated Solution 12.5%; Albon Concentrated Solution 12.5% | Sulfadimethoxine | Zoetis Inc. | Cattle, Chickens, Turkeys | NADA 031-205 |
| Albon or Agribon | Sulfadimethoxine | Zoetis Inc. | Cattle | NADA 031-715 |
| Bactrovet Oral Suspension 12.5% | Sulfadimethoxine | Intervet, Inc. | Dogs, Cats | NADA 037-700 |
| Albon | Sulfadimethoxine | Zoetis Inc. | Dogs, Cats, Horses, Cattle | NADA 041-245 |
| Albon Oral Suspension 5% | Sulfadimethoxine | Zoetis Inc. | Dogs, Cats | NADA 043-785 |
| Albon | Sulfadimethoxine | Zoetis Inc. | Cattle, Chickens, Turkeys | NADA 046-285 |
| Albon S.R. (Sustained Release) | Sulfadimethoxine | Zoetis Inc. | Cattle | NADA 093-107 |
| Medacide-SDM Injection 10% | Sulfadimethoxine | Cronus Pharma Specialities India Private Ltd. | Dogs | NADA 098-569 |
| DI-METHOX | Sulfadimethoxine | Huvepharma EOOD | Cattle, Chickens, Turkeys | ANADA 200-030 |
| DI-METHOX | Sulfadimethoxine | Huvepharma EOOD | Cattle, Chickens, Turkeys | ANADA 200-031 |
| Di-Methox Injection 40% | Sulfadimethoxine | Huvepharma EOOD | Cattle | ANADA 200-038 |
| Sulfadimethoxine Concentrated Solution 12.5% | Sulfadimethoxine | Cronus Pharma Specialities India Private Ltd. | Cattle, Chickens, Turkeys | ANADA 200-165 |
| Sulfadimethoxine Injection 40% | Sulfadimethoxine | Huvepharma EOOD | Cattle | ANADA 200-177 |
| Sulfadimethoxine 12.5% Oral Solution | Sulfadimethoxine | Huvepharma EOOD | Cattle, Chickens, Turkeys | ANADA 200-192 |
| Sulfasol Soluble Powder | Sulfadimethoxine | Dechra Veterinary Products LLC | Cattle, Chickens, Turkeys | ANADA 200-238 |
| Sulforal | Sulfadimethoxine | Dechra Veterinary Products LLC | Cattle, Chickens, Turkeys | ANADA 200-251 |
| Sulfadimethoxine Soluble Powder | Sulfadimethoxine | Phibro Animal Health Corp. | Cattle, Chickens, Turkeys | ANADA 200-258 |
| Sulfamed-G | Sulfadimethoxine | Bimeda Animal Health Ltd. | Cattle, Chickens, Turkeys | ANADA 200-376 |
| Sulfadimethoxine Soluble Powder | Sulfadimethoxine | First Priority, Inc. | Cattle, Chickens, Turkeys | ANADA 200-443 |
| SulfaMed | Sulfadimethoxine | Bimeda Animal Health Ltd. | Cattle | ANADA 200-523 |
| Bactrovet Injectableapproval withdrawn | Sulfadimethoxine | Mallinckrodt Veterinary, Inc. | Not in the list of major species | NADA 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
FDA pages for this drug
- How to Report Animal Drug and Device Side Effects and Product ProblemsThe FDA page that tells an owner or a veterinarian how to send a report.
- Green Book record of NADA 012-087The FDA record of the application for Bactrovet Tablets 250 mg.
- Green Book record of NADA 015-102The FDA record of the application for Albon Tablets.
- Green Book record of NADA 037-700The FDA record of the application for Bactrovet Oral Suspension 12.5%.
- Green Book record of NADA 041-245The FDA record of the application for Albon.
- Green Book record of NADA 043-785The FDA record of the application for Albon Oral Suspension 5%.
- Green Book record of NADA 098-569The FDA record of the application for Medacide-SDM Injection 10%.
- Animal Drugs @ FDAThe search page of the Green Book, the FDA list of approved animal drugs.
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 .
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.