Pet Drug Reports

Ingredients

Active ingredient · pooled across combinations

Sulfadimethoxine: adverse event reports, pooled

3 ingredient sets in reports · 28 FDA-approved applications in the Green Book

2,825reports naming the ingredient, 1990–20260.2% of all reports · about 78 a year
48reports, 12 months to March 202642 in the 12 months before
36.9%classed serious, as reportedall reports: 38.6%
69%of reports concern dogscat 12.7%

2,825 adverse event reports received by FDA list a drug containing sulfadimethoxine, alone or in combination, from January 1990 to March 2026. This page pools every ingredient set that includes it; 3 such sets appear in reports.

The Green Book lists 28 FDA-approved applications containing it. openFDA masks brand and manufacturer names in adverse event records, so the reports counted here cannot be attributed to a particular brand.

48 reports arrived in the 12 months to March 2026, up 14% from 42 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. That is about 78 reports a year over its reporting history and 0.2% of all reports.

Pooled across every set, the terms listed most often are vomiting (11.8%), lack of efficacy (protozoa) - Coccidia (10.8%) and depression (9.7%). Many drugs combine several ingredients, and many reports list several drugs, so a term on this page may relate to any of them or to none.

Of reports that state seriousness, 36.9% were classed as serious (38.6% across the whole database); 11.8% record a death or euthanasia (6.4% overall). Ingredients used in older or sicker animals, or in anaesthesia and cancer care, carry higher shares for that reason alone.

Ingredient sets that include sulfadimethoxine

Active ingredients recorded for the drugReportsShare of this page's reportsLatest 12 months
Sulfadimethoxine1,68359.6%48
Ormetoprim + Sulfadimethoxine1,14540.5%0
Sulfadimethoxine + Trimethoprim20.1%0

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"; counts follow sales volume and years on the market. A report can list more than one set, so shares can add to more than 100%.

Signs listed in reports, pooled

share of sulfadimethoxine reports listing the termall reports in the database

  1. Vomiting11.8%333
  2. Lack of efficacy (protozoa) - Coccidia[the product did not have the expected effect: coccidia]10.8%306
  3. Depression[dull, quiet or withdrawn]9.7%273
  4. Anorexia[not eating]8.1%229
  5. Death7.7%218
  6. Diarrhoea[diarrhea]7.4%209
  7. Fever7%197
  8. Ataxia[unsteady, uncoordinated movement]6.1%171
  9. Lethargy[unusually tired or inactive]5.2%147
  10. Anaemia NOS[low red blood cell count]4.6%131
  11. Convulsion[seizure]4.6%129
  12. Thrombocytopenia[low platelet count]4.1%117
  13. Elevated alanine aminotransferase (ALT)[a liver enzyme above the normal range]3.9%110
  14. Elevated serum alkaline phosphatase (SAP)[a liver and bone enzyme above the normal range]3.9%109
  15. Death by euthanasia[the animal was euthanized]3.5%100
  16. No sign[no clinical sign was reported]3.2%89
  17. Behavioural disorder NOS[behaviour change, type not specified]2.8%80
  18. Trembling2.7%75
  19. Leucocytosis NOS[high white blood cell count]2.6%73
  20. Vials, Leaking[a product quality report, not a sign in an animal]2.6%73
  21. Weakness2.6%73
  22. Elevated total bilirubin[bilirubin above the normal range]2.5%70
  23. Accidental exposure[exposure that was not intended]2.3%64
  24. Lack of efficacy (bacteria) - NOS[the product did not have the expected effect: target not specified]2.2%61
  25. Other abnormal test result NOS[abnormal laboratory result, type not specified]2.2%61
  26. Bolus, Abnormal2.1%60
  27. Elevated blood urea nitrogen (BUN)[a kidney value above the normal range]1.9%55

Pooled across every ingredient set and every report that names the ingredient. One report can list several terms and several drugs; a term here may relate to any of them or to none.

Monthly reports by species, five years

Dog124 · peak 7
Apr 2021: 3May 2021: 1Jun 2021: 3Jul 2021: 1Aug 2021: 2Sep 2021: 4Oct 2021: 2Nov 2021: 1Jan 2022: 1Feb 2022: 1Mar 2022: 2Apr 2022: 3Jun 2022: 1Jul 2022: 1Aug 2022: 1Sep 2022: 5Oct 2022: 2Nov 2022: 2Dec 2022: 2Jan 2023: 4Feb 2023: 1Mar 2023: 2May 2023: 1Jun 2023: 2Jul 2023: 1Aug 2023: 3Sep 2023: 1Oct 2023: 1Nov 2023: 1Dec 2023: 2Jan 2024: 1Feb 2024: 2Mar 2024: 5Apr 2024: 3May 2024: 7Jun 2024: 2Jul 2024: 2Sep 2024: 2Oct 2024: 1Nov 2024: 3Jan 2025: 1Feb 2025: 4Mar 2025: 1Apr 2025: 1May 2025: 3Jun 2025: 1Jul 2025: 1Aug 2025: 4Sep 2025: 3Oct 2025: 4Nov 2025: 4Dec 2025: 4Jan 2026: 3Feb 2026: 3Mar 2026: 22022202320242025
Cat36 · peak 3
Oct 2021: 3Nov 2021: 2Dec 2021: 2Mar 2022: 1Aug 2022: 1Sep 2022: 2May 2023: 1Aug 2023: 3Oct 2023: 1Dec 2023: 2Jan 2024: 1Apr 2024: 1Jun 2024: 1Jul 2024: 2Dec 2024: 2Jan 2025: 1Feb 2025: 3Jul 2025: 2Oct 2025: 3Nov 2025: 22022202320242025
Horse0 · peak 1
2022202320242025
Other27 · peak 2
Jun 2021: 1Aug 2021: 1Jan 2022: 1May 2022: 1Jun 2022: 1Dec 2022: 2Jan 2023: 1May 2023: 1Dec 2023: 1Jan 2024: 1Mar 2024: 2Jun 2024: 1Jul 2024: 2Aug 2024: 1Sep 2024: 1Jan 2025: 1Apr 2025: 1May 2025: 1Aug 2025: 1Sep 2025: 1Oct 2025: 2Dec 2025: 1Feb 2026: 12022202320242025

By month of receipt; each panel has its own scale. The newest months are incomplete because FDA posts reports with a delay of three to six months.

0791581990: 1019901991: 191992: 201993: 81994: 13319941995: 881996: 1101997: 741998: 15819981999: 1352000: 1522001: 1172002: 6620022003: 812004: 1232005: 1052006: 13920062007: 1232008: 832009: 942010: 9220102011: 842012: 952013: 892014: 6520142015: 662016: 712017: 712018: 4520182019: 492020: 602021: 392022: 3020222023: 292024: 432025: 502026: 92026

Outcomes, report types and ages

Outcome recorded in the report

Recovered/Normal6.4%180
Recovered with Sequela0.3%8
Ongoing10.2%288
Died10.8%306
Euthanized1%27
Outcome Unknown6.3%177

What kind of report it was

Safety issue80.6%2,277
Lack of expected effectiveness3%84
Both safety and lack of expected effectiveness2.5%71
Manufacturing or product defect13.9%393
Other0%0

Species

Dog69%1,949
Cat12.7%360
Cattle2.3%64
Human exposure0.9%25
Other0.4%10
Sheep0.2%7

Age of the animal

Under 1 year36.2%1,023
1 to 3 years14.1%397
4 to 7 years12.7%359
8 to 11 years8.8%249
12 years and over4.4%124
Age not given23.8%673

Coloured bar: reports naming sulfadimethoxine. Grey bar: all 1,357,245 reports. Outcomes are as stated by the reporter; FDA has not necessarily determined whether any product played a part.

In context

MeasureSulfadimethoxineAll reports
Reports2,8251,357,245
Latest 12 months against the 12 before+14%-5%
Classed serious, of reports stating it36.9%38.6%
Death or euthanasia recorded, per 1,000 reports117.963.8
Filed as lack of expected effectiveness (wholly or partly)5.5%23%

Shares of reports, not of animals treated: how many animals receive the ingredient is not public. Ingredients used in anaesthesia, cancer care or in old animals carry more serious outcomes in their reports for that reason alone.

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 nameActive ingredientsSponsorApproved forApplication
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 AS—NADA 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 voluntarily withdrawnSulfadimethoxineMallinckrodt Veterinary, Inc.—NADA 012-554
Rofenaid Plus Roxarsoneapproval voluntarily withdrawnOrmetoprim, Roxarsone, SulfadimethoxineZoetis Inc.ChickensNADA 041-984
Rofenaid & Ipropranapproval voluntarily withdrawnIpronidazole, Ormetoprim, SulfadimethoxineRoche Vitamins, Inc.—NADA 047-089

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 FDA adverse event reports mention sulfadimethoxine?

2,825 reports through March 2026, 48 of them in the latest 12 months, counting sulfadimethoxine alone and in combinations.

Which brands 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 reference list on this page names approved products containing sulfadimethoxine without any counts.

In which combinations is sulfadimethoxine reported?

Sulfadimethoxine (59.6% of these reports), Ormetoprim + Sulfadimethoxine (40.5% of these reports) and Sulfadimethoxine + Trimethoprim (0.1% of these reports).

What reactions are reported for sulfadimethoxine?

vomiting (11.8%), lack of efficacy (protozoa) - Coccidia (10.8%), depression (9.7%), anorexia (8.1%) and death (7.7%). Shares are of reports naming the ingredient; one report can list several terms.

Which animals are these reports about?

dog (69%), cat (12.7%) and cattle (2.3%).

Does a high count mean sulfadimethoxine is a problem ingredient?

A count 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." Widely used ingredients collect more reports because more animals receive them.

How do I report a problem?

Call the drug company using the number on the label, or send Form FDA 1932a to FDA. 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. Ingredient names follow the Green Book; salts and forms are kept as FDA lists them. Drug entries are matched by the active ingredients their unmasked ingredient field discloses. 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.