Pet Drug Reports

Ingredients

Active ingredient · pooled across combinations

Sulfamethazine: adverse event reports, pooled

8 ingredient sets in reports · 65 FDA-approved applications in the Green Book

169reports naming the ingredient, 1987–20240% of all reports · about 4 a year
0reports, 12 months to March 20261 in the 12 months before
75.8%classed serious, as reportedall reports: 38.6%
21.3%of reports concern cattlechicken 4.1%

Sulfamethazine appears, alone or combined with other ingredients, in 169 reports in FDA's animal adverse event database (February 1987 to October 2024). The figures here pool all 8 ingredient sets that include it.

The Green Book lists 65 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.

0 reports arrived in the 12 months to March 2026, against 1 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 4 reports a year over its reporting history and 0% of all reports.

Pooled across every set, the terms listed most often are containers, Damaged (17.8%), death (15.4%) and vials, Leaking (11.8%). 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, 75.8% were classed as serious (38.6% across the whole database); 18.9% 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 sulfamethazine

Active ingredients recorded for the drugReportsShare of this page's reportsLatest 12 months
Sulfamethazine11065.1%0
Chlortetracycline Bisulfate + Sulfamethazine1710.1%0
Chlortetracycline + Sulfamethazine169.5%0
Sulfamethazine + Tylosin116.5%0
Chlortetracycline Calcium Complex + Sulfamethazine116.5%0
Sulfamethazine + Tylosin Phosphate21.2%0
Sulfamethazine + Sulfathiazole10.6%0
Chlortetracycline Hydrochloride + Sulfamethazine10.6%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 sulfamethazine reports listing the termall reports in the database

  1. Containers, Damaged[a product quality report, not a sign in an animal]17.8%30
  2. Death15.4%26
  3. Vials, Leaking[a product quality report, not a sign in an animal]11.8%20
  4. Caps, Abnormal[a product quality report, not a sign in an animal]5.9%10
  5. Lack of efficacy - NOS[the product did not have the expected effect]4.7%8
  6. Lack of efficacy (bacteria) - NOS[the product did not have the expected effect: target not specified]4.1%7
  7. Seal, Abnormal[a product quality report, not a sign in an animal]4.1%7
  8. Color, Abnormal[a product quality report, not a sign in an animal]3.6%6
  9. Containers, Abnormal[a product quality report, not a sign in an animal]3%5
  10. Diarrhoea[diarrhea]3%5
  11. Product Defect, General[a product quality report, not a sign in an animal]3%5
  12. Tablets, Abnormal[a product quality report, not a sign in an animal]3%5
  13. Anorexia[not eating]2.4%4
  14. Lack of efficacy (protozoa) - Coccidia[the product did not have the expected effect: coccidia]2.4%4
  15. No sign[no clinical sign was reported]2.4%4
  16. Product label issues[a product quality report, not a sign in an animal]2.4%4
  17. Solution, Abnormal[a product quality report, not a sign in an animal]2.4%4
  18. Bolus, Abnormal1.8%3
  19. Contamination NOS[NOS: not otherwise specified]1.8%3
  20. Death by euthanasia[the animal was euthanized]1.8%3
  21. Accidental exposure[exposure that was not intended]1.2%2
  22. Ataxia[unsteady, uncoordinated movement]1.2%2
  23. Depression[dull, quiet or withdrawn]1.2%2
  24. Recumbency[lying down and unable or unwilling to rise]1.2%2

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

Dog0 · peak 1
2022202320242025
Cat0 · peak 1
2022202320242025
Horse0 · peak 1
2022202320242025
Other6 · peak 1
Mar 2022: 1Aug 2022: 1Dec 2022: 1Mar 2023: 1Feb 2024: 1Oct 2024: 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.

07141987: 319871988: 11989: 11990: 119901995: 21997: 51998: 219981999: 72000: 62001: 120012002: 142003: 132004: 920042005: 72006: 62007: 520072008: 142009: 62010: 920102011: 62012: 102013: 920132014: 62015: 82016: 520162017: 22019: 32020: 220202022: 32023: 12024: 22024

Outcomes, report types and ages

Outcome recorded in the report

Recovered/Normal4.7%8
Recovered with Sequela0.6%1
Ongoing1.2%2
Died18.3%31
Euthanized1.8%3
Outcome Unknown10.1%17

What kind of report it was

Safety issue28.4%48
Lack of expected effectiveness4.7%8
Both safety and lack of expected effectiveness1.8%3
Manufacturing or product defect65.1%110
Other0%0

Species

Cattle21.3%36
Chicken4.1%7
Pig3.6%6
Other Birds2.4%4
Dog1.2%2
Human exposure1.2%2

Age of the animal

Under 1 year9.5%16
1 to 3 years3.6%6
4 to 7 years1.2%2
8 to 11 years0%0
12 years and over0.6%1
Age not given85.2%144

Coloured bar: reports naming sulfamethazine. 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

MeasureSulfamethazineAll reports
Reports1691,357,245
Latest 12 months against the 12 before-100%-5%
Classed serious, of reports stating it75.8%38.6%
Death or euthanasia recorded, per 1,000 reports189.363.8
Filed as lack of expected effectiveness (wholly or partly)6.5%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 sulfamethazine (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
Sulmet Drinking Water Solution, 12.5%SulfamethazineHuvepharma EOODCattle, Swine, Chickens, TurkeysNADA 006-084
Sulmet Solution InjectableSulfamethazineHuvepharma EOODCattleNADA 008-774
Aureomix S 40/40 GranularChlortetracycline, SulfamethazinePhibro Animal Health Corp.SwineNADA 035-688
Aureo S 700 Granular; Aureo S 700Chlortetracycline, SulfamethazinePhibro Animal Health Corp.CattleNADA 035-805
Tylan 5 Sulfa-G; Tylan 10 Sulfa-G; Tylan 20 Sulfa-G; Tylan 40 Sulfa-GSulfamethazine, Tylosin PhosphateElanco US Inc.SwineNADA 041-275
Aureomix S 700-AChlortetracycline, SulfamethazinePhibro Animal Health Corp.CattleNADA 041-647
Aureomix S 700-DChlortetracycline, SulfamethazinePhibro Animal Health Corp.CattleNADA 041-648
Aureomix S 700-GChlortetracycline, SulfamethazinePhibro Animal Health Corp.CattleNADA 041-649
Aureomix S 700-EChlortetracycline, SulfamethazinePhibro Animal Health Corp.CattleNADA 041-650
Aureomix 700-FChlortetracycline, SulfamethazinePhibro Animal Health Corp.CattleNADA 041-651
Aureomix S 700-CChlortetracycline, SulfamethazinePhibro Animal Health Corp.CattleNADA 041-652
Aureomix S 700-BChlortetracycline, SulfamethazinePhibro Animal Health Corp.CattleNADA 041-653
Aureomix S 700-HChlortetracycline, SulfamethazinePhibro Animal Health Corp.CattleNADA 041-654
Sulfamethazine Spanbolet IISulfamethazineZoetis Inc.CattleNADA 049-892
Tylan 10 Sulfa-G; Tylan 40 Sulfa-GSulfamethazine, Tylosin PhosphatePhibro Animal Health Corp.SwineNADA 091-749
PoultrySulfaSulfamerazine, Sulfamethazine, SulfaquinoxalineHuvepharma EOODChickens, TurkeysNADA 100-094
Sustain III Bolus; Sustain III Calf BolusSulfamethazineBimeda Animal Health Ltd.CattleNADA 120-615
Sulmet ObletsSulfamethazineHuvepharma EOODHorses, CattleNADA 122-271
CalfspanSulfamethazineZoetis Inc.CattleNADA 126-232
Pennchlor S 40/40Chlortetracycline, SulfamethazinePharmgate Inc.SwineNADA 138-934
SulfaTECH SRSulfamethazineHuvepharma EOODCattleNADA 140-270
Sulka-S BolusSulfamethazineZoetis Inc.CattleNADA 140-909
Aureo S 700 and BovatecChlortetracycline, Lasalocid, SulfamethazinePhibro Animal Health Corp.CattleNADA 141-535
Pennchlor SChlortetracycline, SulfamethazinePharmgate Inc.CattleANADA 200-314
Tylocine Sulfa Tablets 50approval voluntarily withdrawnSulfadiazine, Sulfamerazine, Sulfamethazine, TylosinElanco Animal Health, A Division of Eli Lilly & Co.—NADA 030-330
Purina Pork-Plus Medicatedapproval voluntarily withdrawnSulfamethazine, Tylosin PhosphateVirbac AH, Inc.SwineNADA 042-660
Purina Sulfaapproval voluntarily withdrawnSulfamethazineCross Vetpharm Group Ltd.Cattle, Swine, Chickens, TurkeysNADA 049-729
Aureo Sulfa Soluble Powderapproval voluntarily withdrawnChlortetracycline Bisulfate, SulfamethazinePurina Mills, Inc.SwineNADA 065-113
Chlorachel 250 Swine; Pficlor 1000; Pficlor 250; Pficlor-SP 250approval voluntarily withdrawnChlortetracycline Calcium Complex, Penicillin G Procaine, SulfamethazineZoetis Inc.SwineNADA 091-668
HavaSpan Prolonged Release Bolus; SulfaSpan Prolonged Release Bolusapproval voluntarily withdrawnSulfamethazineElanco US Inc.CattleNADA 093-329
Hubbard Tylan Plus Sulfa Premixapproval voluntarily withdrawnSulfamethazine, Tylosin PhosphateHubbard Milling Co.—NADA 094-402
Swine Med-A-Mix TS 8000 Premix; Tylan 10 Sulfa-G; Tylan 20 Sulfa-G; Tylan 40 Sulfa-G; Tylan 5 Sulfa-Gapproval voluntarily withdrawnSulfamethazine, Tylosin PhosphateGolden Sun Feeds, Inc.—NADA 097-615
Quali-Tech Tylan-Sulfa Premix 10 -10; Tylan 10 Sulfa-G; Tylan 20 Sulfa-G; Tylan 40 Sulfa-G; Tylan 5 Sulfa-Gapproval voluntarily withdrawnSulfamethazine, Tylosin PhosphateQuali-Tech Products, Inc.SwineNADA 097-981
Medi-Flex T:S; Tylan Sulfa 10-10 Premixapproval voluntarily withdrawnSulfamethazine, Tylosin PhosphateLand OLakes Purina Feed LLC—NADA 098-156
Tylan Sulfa 10 G; Tylan Sulfa 20 G; Tylan Sulfa 40 G; Tylan Sulfa 5 Gapproval voluntarily withdrawnSulfamethazine, Tylosin PhosphateTriple "F", Inc.—NADA 099-561
Purina Tylan 40 Plus Sulfamethazineapproval voluntarily withdrawnSulfamethazine, Tylosin PhosphateVirbac AH, Inc.SwineNADA 099-767
V.P.O. Tylan Plus Sulfaapproval voluntarily withdrawnSulfamethazine, TylosinSmithKline Beecham Animal Health—NADA 100-127
Mill Co Medicator TS-40 Premixapproval voluntarily withdrawnSulfamethazine, Tylosin PhosphateWaterloo Mills Co.SwineNADA 101-906
Seeco Tylan-Sulfa 10 Premix Med.approval voluntarily withdrawnSulfamethazine, Tylosin PhosphateTruow Nutrition, Inc.SwineNADA 107-002
Tylan 20 Sulfa-G; Tylan 40 Sulfa-Gapproval voluntarily withdrawnSulfamethazine, Tylosin PhosphateADM Alliance Nutrition, Inc.SwineNADA 107-957
HFA Tylosin-10 Plus Sulfaapproval voluntarily withdrawnSulfamethazine, Tylosin PhosphateADM Alliance Nutrition, Inc.SwineNADA 108-484
Tylan 10 Sulfa-G; Tylan 20 Sulfa-G; Tylan 40 Sulfa-G; Tylan 5 Sulfa-Gapproval voluntarily withdrawnSulfamethazine, Tylosin PhosphateInternational Nutrition, Inc.SwineNADA 109-816
Tylan 10 Sulfa-G; Tylan 20 Sulfa-G; Tylan 40 Sulfa-G; Tylan 5 Sulfa-Gapproval voluntarily withdrawnSulfamethazine, Tylosin PhosphateADM Alliance Nutrition, Inc.SwineNADA 111-069
Heinold Tylan 5 Sulfa Premix; Tylan 10 Sulfa-G; Tylan 20 Sulfa-G; Tylan 40 Sulfa-G; Tylan 5 Sulfa-Gapproval voluntarily withdrawnSulfamethazine, Tylosin PhosphateHeinold Feeds, Inc.—NADA 127-506
Tylan 10 Sulfa-G; Tylan 20 Sulfa-G; Tylan 40 Sulfa-G; Tylan 5 Sulfa-Gapproval voluntarily withdrawnSulfamethazine, Tylosin PhosphateElanco US, Inc.SwineNADA 127-507
Tylan Sulfaapproval voluntarily withdrawnSulfamethazine, Tylosin PhosphateADM Alliance Nutrition, Inc.—NADA 127-826
Tylan 10 Sulfa Premix; Tylan 5 Sulfa Premixapproval voluntarily withdrawnSulfamethazine, Tylosin PhosphateKay Dee Feed Co.—NADA 128-255
Tylan 5 Sulfa Premixapproval voluntarily withdrawnSulfamethazine, Tylosin PhosphateADM Alliance Nutrition, Inc.SwineNADA 128-411
Tylan 10 Sulfa-G; Tylan 20 Sulfa-G; Tylan 40 Sulfa-G; Tylan 5 Sulfa-Gapproval voluntarily withdrawnSulfamethazine, Tylosin PhosphateOld Monroe Elevator & Supply Co., Inc.—NADA 128-835
Tylan 10 Sulfa-G; Tylan 20 Sulfa-G; Tylan 40 Sulfa-G; Tylan 5 Sulfa-Gapproval voluntarily withdrawnSulfamethazine, Tylosin PhosphateCustom Feed Services Corp.SwineNADA 129-159
Nutra-Blend Tylan 5 Sulfa Premix; Tylan 10 Sulfa Premix; Tylan 20 Sulfa Premix; Tylan 40 Sulfa Premix; Tylan 5 Sulfa Premixapproval voluntarily withdrawnSulfamethazine, Tylosin PhosphateNutra-Blend Corp.SwineNADA 129-161
Tylan 10 Sulfa-G; Tylan 20 Sulfa-G; Tylan 40 Sulfa-G; Tylan 5 Sulfa Premix; Tylan 5 Sulfa-Gapproval voluntarily withdrawnSulfamethazine, Tylosin PhosphateI.M.S., Inc.SwineNADA 129-646
Tylan 10 Sulfa-G; Tylan 20 Sulfa-G; Tylan 40 Sulfa-G; Tylan 5 Sulfa-Gapproval voluntarily withdrawnSulfamethazine, Tylosin PhosphateGrowmark, Inc.—NADA 130-465
Tylan Sulfa-Gapproval voluntarily withdrawnSulfamethazine, TylosinADM Alliance Nutrition, Inc.SwineNADA 131-956
Tylan Sulfa-Gapproval voluntarily withdrawnSulfamethazine, Tylosin PhosphateWayne Feed Division, Continental Grain Co.SwineNADA 131-958
Tylan 10 Sulfa-G Premix; Tylan 20 Sulfa-G Premix; Tylan 40 Sulfa-G Premix; Tylan 5 Sulfa-G Premixapproval voluntarily withdrawnSulfamethazine, Tylosin PhosphateFeed Service Co., Inc.SwineNADA 138-342
Tylan Sulfa-Gapproval voluntarily withdrawnSulfamethazine, Tylosin PhosphateOhio Farmers Grain and Supply Association—NADA 138-343
Tylan 10 Sulfa-G Premix; Tylan 20 Sulfa-G Premix; Tylan 40 Sulfa-G Premix; Tylan 5 Sulfa-G Premixapproval voluntarily withdrawnSulfamethazine, Tylosin PhosphateSouthern Micro-Blenders, Inc.—NADA 138-453
Tylan 10 Sulfa-G Premix; Tylan 20 Sulfa-G Premix; Tylan 40 Sulfa-G Premix; Tylan 5 Sulfa-G Premixapproval voluntarily withdrawnSulfamethazine, Tylosin PhosphateJ & R Specialty Supply Co.—NADA 138-454
Tylan 10 Sulfa-G Premix; Tylan 20 Sulfa-G Premix; Tylan 40 Sulfa-G Premix; Tylan 5 Sulfa-G Premixapproval voluntarily withdrawnSulfamethazine, Tylosin PhosphateWalnut Grove Products—NADA 139-301

Showing 60 of 65 applications; the full list is at Animal Drugs @ FDA.

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 sulfamethazine reports

How many FDA adverse event reports mention sulfamethazine?

169 reports through March 2026, 0 of them in the latest 12 months, counting sulfamethazine 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 sulfamethazine without any counts.

In which combinations is sulfamethazine reported?

Sulfamethazine (65.1% of these reports), Chlortetracycline Bisulfate + Sulfamethazine (10.1% of these reports), Chlortetracycline + Sulfamethazine (9.5% of these reports), Sulfamethazine + Tylosin (6.5% of these reports) and Chlortetracycline Calcium Complex + Sulfamethazine (6.5% of these reports).

What reactions are reported for sulfamethazine?

containers, Damaged (17.8%), death (15.4%), vials, Leaking (11.8%), caps, Abnormal (5.9%) and lack of efficacy - NOS (4.7%). Shares are of reports naming the ingredient; one report can list several terms.

Which animals are these reports about?

cattle (21.3%), chicken (4.1%) and pig (3.6%).

Does a high count mean sulfamethazine 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.