Drug · single active ingredient
Sulfadimethoxine: adverse event reports
All products with this active ingredient · 23 FDA-approved applications in the Green Book
- Mostly dog reports
- Oral route most often
- Brands masked by FDA
FDA has received 1,683 adverse event reports in which a drug is recorded with sulfadimethoxine as its active ingredient, from March 1991 to March 2026. The Green Book lists 23 FDA-approved applications with this single active ingredient.
openFDA masks the brand and manufacturer in every report, so these figures describe the ingredient across all products and cannot be attributed to a brand.
In the 12 months to March 2026, 48 reports named it, up 17% from 41 in the 12 months before. FDA posts reports quarterly with a delay of three to six months, so the newest months are incomplete and usually grow in later releases. Over its whole reporting history that is about 48 reports a year and 0.1% of all 1,357,245 reports (0.1% of all dog reports). How many animals received it is not published, so a count says nothing about how often a problem occurs per dose.
The most frequently coded terms are lack of efficacy (protozoa) - Coccidia (17.6%), vomiting (12.3%) and diarrhoea (10.1%). A report can list several signs, so shares add to more than 100%; 727 different terms appear across these reports. Lack of efficacy (protozoa) - Coccidia appears in 17.6% of these reports, a larger share than in the pooled reports for every drug containing sulfadimethoxine (10.8%).
53.7% of reports concern dogs. Not every report describes illness: 21.2% as product or packaging defects. Of reports that state seriousness, 38.7% were classed as serious, and 12.5% of all reports record a death or euthanasia as an outcome, as reported. FDA has not necessarily determined whether any drug played a part.
Monthly reports by species, five years
Reports by the month FDA received them. Each panel has its own scale; the peak month is printed at the top right. The newest months are incomplete because FDA posts reports with a delay of three to six months.
Reports by year received
2026 covers reports received through March 2026 only.
Signs listed in reports
share of sulfadimethoxine reports listing the termall drugs containing sulfadimethoxineall dog reports
- Lack of efficacy (protozoa) - Coccidia[the product did not have the expected effect: coccidia]17.6%296
- Vomiting12.3%207
- Diarrhoea[diarrhea]10.1%170
- Death8.6%144
- Depression[dull, quiet or withdrawn]6.8%114
- Lethargy[unusually tired or inactive]6.7%113
- Anorexia[not eating]5.6%94
- Fever4.5%75
- Vials, Leaking[a product quality report, not a sign in an animal]4.3%73
- Anaemia NOS[low red blood cell count]3.9%65
- Bolus, Abnormal3.6%60
- No sign[no clinical sign was reported]3.4%58
- Ataxia[unsteady, uncoordinated movement]3.2%54
- Death by euthanasia[the animal was euthanized]3.1%52
- Containers, Damaged[a product quality report, not a sign in an animal]2.6%44
- Other abnormal test result NOS[abnormal laboratory result, type not specified]2.5%42
- Accidental exposure[exposure that was not intended]2.4%40
- Convulsion[seizure]2.3%38
- Pruritus[itching]2.3%38
- Facial oedema[swollen face]2.2%37
- Weakness2.2%37
- Vials, Damaged[a product quality report, not a sign in an animal]2.1%36
- Dehydration2.1%35
- Emesis[vomiting]2%34
- Leucocytosis NOS[high white blood cell count]2%34
- Seal, Abnormal[a product quality report, not a sign in an animal]2%34
- Caps, Abnormal[a product quality report, not a sign in an animal]1.8%31
- Uncoded sign[a sign with no matching dictionary term]1.8%31
- Weight loss1.8%30
- Bloody diarrhoea[diarrhea with blood]1.7%29
Top 30 of 727 coded terms (VeDDRA, the veterinary reporting dictionary; plain-language gloss in brackets). One report can list several terms. The ticks show how often the same term appears in a wider pool of reports; they describe the reports, and FDA cautions that such figures cannot be used to estimate risk or to compare one product with another. openFDA masks brand and manufacturer names in adverse event records, so the reports counted here cannot be attributed to a particular brand.
Outcomes and report types
Outcome recorded in the report
What kind of report it was
Coloured bar: reports naming sulfadimethoxine. Grey bar: all 1,357,245 reports in the database. Outcomes are the status at the time of the last report, as stated by the reporter; a report covering several animals can carry more than one outcome. FDA has not necessarily determined whether any drug played a part in any outcome.
Species and breeds in the reports
Single-breed animals
Breed shares follow how common each breed is. Crossbred animals and reports with no breed stay in the species figure only.
Age, weight and route
Age of the animal
Weight of the animal
Route of administration stated in reports: oral (1,216), intravenous (11), subcutaneous (7), topical (5), intramuscular (2), nasal (1).
In context
| Measure | Sulfadimethoxine | All drugs containing sulfadimethoxine | All dog reports | All reports |
|---|---|---|---|---|
| Reports | 1,683 | 2,825 | 985,675 | 1,357,245 |
| Share of that pool's reports naming this drug | — | 59.6% | 0.1% | 0.1% |
| Classed serious, of reports stating it | 38.7% | 36.9% | 38.3% | 38.6% |
| Death or euthanasia recorded, per 1,000 reports | 125.4 | 118 | 55 | 63.8 |
| Filed as lack of expected effectiveness (wholly or partly) | 8.1% | — | — | 23% |
| Top term, share of reports | Lack of efficacy (protozoa) - Coccidia 17.6% | 10.8% | 0.4% | — |
The sulfadimethoxine pool is every report naming sulfadimethoxine alone or in any combination; this single-ingredient set accounts for 59.6% of it. Shares are of reports, not of animals treated. The number of doses sold is not public, so none of these figures is a rate of occurrence, and differences between columns reflect which animals receive a drug and who reports as much as anything else.
Other ingredient sets sharing an ingredient
| Active ingredients | Reports | Latest 12 months |
|---|---|---|
| Ormetoprim + Sulfadimethoxine | 1,145 | 0 |
Listed for navigation, ordered by report count. FDA states that these data "cannot be used to estimate the risk associated with the product or compare one drug or device product with another": drugs differ in formulation, in the animals they are given to, in sales volume and in years on the market. A report's ingredient field can be incomplete, so reports about one product may sit under more than one set.
FDA-approved products containing sulfadimethoxine (Green Book)
Reference information, not report statistics. openFDA masks brand and manufacturer names in adverse event records, so the reports counted here cannot be attributed to a particular brand. The list below is the FDA Green Book as of 1 Oct 2026; nothing on this page says which of these products, if any, a report concerned.
| Trade name | Active ingredients | Sponsor | Approved for | 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 voluntarily withdrawn | Sulfadimethoxine | Mallinckrodt Veterinary, Inc. | — | NADA 012-554 |
Species are the major species the Green Book search lists for the application ("—" where it lists another species or none). Approval dates are not part of the Green Book listing files and are not shown. Pioneer applications (NADA) come first, then generics (ANADA).
Questions about sulfadimethoxine reports
How many adverse event reports has FDA received for sulfadimethoxine?
1,683 reports record a drug with sulfadimethoxine as its active ingredient in the openFDA release of 28 Sep 2026, covering reports received through March 2026. 48 of them arrived in the latest 12 months.
Which brand do these reports concern?
That cannot be known from the public data. openFDA masks brand and manufacturer names in adverse event records, so the reports counted here cannot be attributed to a particular brand. The Green Book lists 23 approved applications with this ingredient alone; the reference list on this page names them without any counts.
What signs are reported most often?
lack of efficacy (protozoa) - Coccidia (17.6%), vomiting (12.3%), diarrhoea (10.1%), death (8.6%) and depression (6.8%). These are the coded terms listed in reports; several can appear in one report, and a term's presence is not a finding that the drug was responsible.
Which species and breeds appear in these reports?
dog (53.7%), cat (19%) and cattle (3.8%). Among single-breed animals the most frequent labels are Domestic, Labrador Retriever, Golden Retriever and Domestic Shorthair; popular breeds appear often in any drug's reports because there are more of them.
Are reports rising?
48 reports in the 12 months to March 2026, up 17% from 41 in the 12 months before. FDA posts reports quarterly with a delay of three to six months, so the newest months are incomplete and usually grow in later releases. Counts also move with sales, publicity and time on the market.
Do these reports show that sulfadimethoxine harms pets?
Report counts cannot show that. FDA states that "there is no certainty that the reported drug or device caused the adverse event" and that the event "may have been related to an underlying disease, other drugs used at the same time or other non-drug related sources." FDA also notes that commonly used products may have more reports simply because more animals receive them.
Are these the side effects of sulfadimethoxine?
They are signs listed in reports, not an established list of side effects. The adverse reactions observed in studies are printed on each product's FDA-approved label, which a veterinarian can go through with you. This page is a record of what was reported to FDA.
How do I report a problem with an animal drug?
FDA asks owners and veterinarians to call the drug company first (the number is on the label); companies must pass reports to FDA. Reports can also go directly to FDA on Form FDA 1932a. See the guide on how to report.
Where this comes from. Counts are built from the openFDA Animal & Veterinary adverse event bulk files released 28 Sep 2026, which hold reports FDA's Center for Veterinary Medicine received through 31 Mar 2026. openFDA masks brand and manufacturer names in these files, so drugs are counted by the active ingredients each record discloses and no figure is attributed to a brand, application or company. Ingredient names, and the separate reference lists of approved products, follow the FDA Green Book as of 1 Oct 2026. Drug entries are grouped by the active ingredients their unmasked ingredient field discloses; the application number that records also carry is not used. No report text, lot numbers or reporter details are published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.