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 FDAFDA 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
| Species | Jan to Mar 2026 | Oct to Dec 2025 | Jan to Mar 2025 |
|---|---|---|---|
| All species | 13 | 20 | 11 |
| Dog | 11 | 12 | 6 |
| Cat | 1 | 5 | 4 |
| Horse | 0 | 0 | 0 |
| Other or not given | 1 | 3 | 1 |
January to March 2026 is the latest closed quarter in the data.
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.
| Active ingredients | Reports, all years | Reports, latest 12 months |
|---|---|---|
| Ormetoprim + Sulfadimethoxine | 1,147 | 2 |
| Sulfadimethoxine | 1,705 | 63 |
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.
- Vomiting12.1%345 reports
- Lack of efficacy (protozoa) - Coccidia[the product did not have the expected effect: coccidia]10.9%310 reports
- Depression[dull, quiet or withdrawn]9.6%273 reports
- Anorexia[not eating]8%229 reports
- Death7.7%220 reports
- Diarrhoea[diarrhea]7.5%213 reports
- Fever6.9%197 reports
- Ataxia[unsteady, uncoordinated movement]6%171 reports
- Lethargy[unusually tired or inactive]5.3%150 reports
- Anaemia NOS[low red blood cell count]4.6%131 reports
- Convulsion[seizure]4.5%129 reports
- Thrombocytopenia[low platelet count]4.1%117 reports
- Elevated alanine aminotransferase (ALT)[a liver enzyme above the normal range]3.9%111 reports
- Elevated serum alkaline phosphatase (SAP)[a liver and bone enzyme above the normal range]3.8%109 reports
Show the next 16 signs
- Death by euthanasia[the animal was euthanized]3.5%101 reports
- No sign[no clinical sign was reported]3.1%89 reports
- Behavioural disorder NOS[behaviour change, type not specified]2.8%80 reports
- Trembling2.6%75 reports
- Leucocytosis NOS[high white blood cell count]2.6%73 reports
- Vials, Leaking[a product quality report, not a sign in an animal]2.6%73 reports
- Weakness2.6%73 reports
- Elevated total bilirubin[bilirubin above the normal range]2.5%72 reports
- Weight loss2.4%68 reports
- Keratoconjunctivitis sicca2.3%66 reports
- Accidental exposure[exposure that was not intended]2.2%64 reports
- Other abnormal test result NOS[abnormal laboratory result, type not specified]2.2%64 reports
- Lack of efficacy (bacteria) - NOS[the product did not have the expected effect: target not specified]2.1%61 reports
- Bolus, Abnormal2.1%60 reports
- Aggression2%58 reports
- Elevated blood urea nitrogen (BUN)[a kidney value above the normal range]2%56 reports
Reports by 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 | 25 | 3 | 0 | 5 | 33 |
| 2025 | 31 | 11 | 0 | 8 | 50 |
| 2024 | 28 | 7 | 0 | 8 | 43 |
| 2023 | 19 | 7 | 0 | 3 | 29 |
| 2022 | 21 | 4 | 0 | 5 | 30 |
| 2021 | 25 | 10 | 0 | 4 | 39 |
| 2020 | 37 | 8 | 0 | 15 | 60 |
| 2019 | 35 | 7 | 0 | 7 | 49 |
| 2018 | 29 | 3 | 0 | 13 | 45 |
| 2017 | 52 | 11 | 0 | 8 | 71 |
| 2016 | 59 | 5 | 0 | 7 | 71 |
| 2015 | 43 | 8 | 0 | 15 | 66 |
| 2014 | 48 | 6 | 0 | 11 | 65 |
| 2013 | 65 | 11 | 0 | 13 | 89 |
| 2012 | 74 | 9 | 0 | 12 | 95 |
| 2011 | 55 | 8 | 0 | 21 | 84 |
| 2010 | 49 | 11 | 1 | 31 | 92 |
| 2009 | 50 | 14 | 0 | 30 | 94 |
| 2008 | 48 | 12 | 0 | 23 | 83 |
| 2007 | 79 | 20 | 0 | 24 | 123 |
| 2006 | 97 | 19 | 1 | 22 | 139 |
| 2005 | 65 | 18 | 0 | 22 | 105 |
| 2004 | 79 | 26 | 0 | 18 | 123 |
| 2003 | 49 | 15 | 0 | 17 | 81 |
| 2002 | 50 | 7 | 0 | 9 | 66 |
| 2001 | 75 | 14 | 0 | 28 | 117 |
| 2000 | 82 | 24 | 0 | 46 | 152 |
| 1999 | 91 | 18 | 0 | 26 | 135 |
| 1998 | 97 | 16 | 0 | 45 | 158 |
| 1997 | 63 | 5 | 0 | 6 | 74 |
| 1996 | 97 | 12 | 0 | 1 | 110 |
| 1995 | 76 | 6 | 0 | 6 | 88 |
| 1994 | 120 | 6 | 0 | 7 | 133 |
| 1993 | 7 | 1 | 0 | 0 | 8 |
| 1992 | 20 | 0 | 0 | 0 | 20 |
| 1991 | 16 | 1 | 0 | 2 | 19 |
| 1990 | 10 | 0 | 0 | 0 | 10 |
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.
| 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 |
| Rofenaid 40 | Ormetoprim, Sulfadimethoxine | Phibro Animal Health Corp. | Chickens, Turkeys | NADA 040-209 |
| 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 |
| Primor Tablets | Ormetoprim, Sulfadimethoxine | Zoetis Inc. | Dogs | NADA 100-929 |
| Romet-30 | Ormetoprim, Sulfadimethoxine | Pharmaq AS | Not in the list of major species | NADA 125-933 |
| 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 |
| Rofenaid Plus Roxarsoneapproval withdrawn | Ormetoprim, Roxarsone, Sulfadimethoxine | Zoetis Inc. | Chickens | NADA 041-984 |
| Rofenaid & Ipropranapproval withdrawn | Ipronidazole, Ormetoprim, Sulfadimethoxine | Roche Vitamins, Inc. | Not in the list of major species | NADA 047-089 |
FDA pages for this ingredient
- 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, 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 .
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.