Pet Drug Reports

Drugs by active ingredient

Drug · single active ingredient

Phenylbutazone: adverse event reports

All products with this active ingredient · 36 FDA-approved applications in the Green Book

219reports naming this ingredient, 1988–20260% of all reports · about 6 a year
17reports, 12 months to March 20269 in the 12 months before
64.4%classed serious, as reportedof 104 reports stating it
22.4%record death or euthanasia, as reported49 reports
66.7%of reports concern horses0.8% of all horse reports

FDA has received 219 adverse event reports in which a drug is recorded with phenylbutazone as its active ingredient, from April 1988 to January 2026. The Green Book lists 36 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, 17 reports named it, up 89% from 9 in the 12 months before. Recent months are provisional: 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 6 reports a year and 0% of all 1,357,245 reports (0.8% of all horse reports). How many animals received it is not published, so a count says nothing about how often a problem occurs per dose.

Reporters most often listed death (11.9%), death by euthanasia (8.7%) and diarrhoea (8.2%). A report can list several signs, so shares add to more than 100%; 353 different terms appear across these reports.

66.7% of reports concern horses. Not every report describes illness: 22.8% as product or packaging defects. Of reports that state seriousness, 64.4% were classed as serious, and 22.4% 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

Dog0 · peak 1
2022202320242025
Cat0 · peak 1
2022202320242025
Horse48 · peak 3
Jun 2021: 1Aug 2021: 2Sep 2021: 2Oct 2021: 2Jan 2022: 1Feb 2022: 1Apr 2022: 1May 2022: 1Jun 2022: 1Aug 2022: 1Nov 2022: 1Jan 2023: 1Apr 2023: 1May 2023: 2Jun 2023: 2Aug 2023: 3Oct 2023: 1Nov 2023: 2Mar 2024: 1Apr 2024: 1Jun 2024: 1Sep 2024: 1Nov 2024: 1Dec 2024: 2Apr 2025: 3Jun 2025: 3Aug 2025: 1Sep 2025: 1Oct 2025: 1Nov 2025: 1Dec 2025: 3Jan 2026: 22022202320242025
Other11 · peak 2
Apr 2022: 1Aug 2022: 1Oct 2022: 1Mar 2023: 1Nov 2023: 1Mar 2024: 1Sep 2024: 1Oct 2024: 2Aug 2025: 1Nov 2025: 12022202320242025

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

08151988: 119881990: 31992: 21993: 21994: 319941995: 51996: 61997: 21998: 519981999: 42000: 62001: 72002: 320022003: 52004: 22005: 62006: 520062007: 32008: 22009: 22010: 120102011: 42012: 82013: 92014: 620142015: 82016: 122017: 102018: 520182019: 72020: 132021: 102022: 1020222023: 142024: 112025: 152026: 22026

2026 covers reports received through March 2026 only.

Signs listed in reports

share of phenylbutazone reports listing the termall horse reports

  1. Death11.9%26
  2. Death by euthanasia[the animal was euthanized]8.7%19
  3. Diarrhoea[diarrhea]8.2%18
  4. Anorexia[not eating]7.8%17
  5. Colic7.8%17
  6. Fever6.8%15
  7. Elevated blood urea nitrogen (BUN)[a kidney value above the normal range]6.4%14
  8. Elevated creatinine[a kidney value above the normal range]6.4%14
  9. Injection site swelling[swelling where the injection was given]5.9%13
  10. Lethargy[unusually tired or inactive]5.5%12
  11. Accidental exposure[exposure that was not intended]4.6%10
  12. Polydipsia[drinking more than usual]4.6%10
  13. Polyuria[passing more urine than usual]4.6%10
  14. Colitis4.1%9
  15. Tachycardia[fast heart rate]4.1%9
  16. Anaemia NOS[low red blood cell count]3.7%8
  17. Ataxia[unsteady, uncoordinated movement]3.7%8
  18. Depression[dull, quiet or withdrawn]3.7%8
  19. Product syringe issue[a product quality report, not a sign in an animal]3.7%8
  20. Tubes, Leaking[a product quality report, not a sign in an animal]3.7%8
  21. Localised pain NOS[NOS: not otherwise specified]3.2%7
  22. Product problem[a product quality report, not a sign in an animal]3.2%7
  23. Convulsion[seizure]2.7%6
  24. Injection site pain[pain where the injection was given]2.7%6
  25. Pawing2.7%6

Top 30 of 353 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

Recovered/Normal16.9%37
Recovered with Sequela0.9%2
Ongoing6.4%14
Died17.4%38
Euthanized5%11
Outcome Unknown16.9%37

What kind of report it was

Safety issue73.1%160
Lack of expected effectiveness0.9%2
Both safety and lack of expected effectiveness1.8%4
Manufacturing or product defect22.8%50
Other1.4%3

Coloured bar: reports naming phenylbutazone. 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

Species

Horse66.7%146
Dog8.2%18
Cat0.9%2
Donkey0.5%1
Other0.5%1
Other Equids0.5%1

Single-breed animals

Arab4.1%9
Paint1.4%3
Shetland Pony1.4%3

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

Under 1 year2.7%6
1 to 3 years8.2%18
4 to 7 years15.5%34
8 to 11 years14.2%31
12 years and over28.3%62
Age not given31.1%68

Weight of the animal

Under 5 kg (11 lb)0%0
5 to 9.9 kg (11–22 lb)0.9%2
10 to 24.9 kg (22–55 lb)1.4%3
25 to 44.9 kg (55–99 lb)4.6%10
45 kg and over (99 lb+)50.2%110
Weight not given42.9%94

Route of administration stated in reports: oral (85), intravenous (33), parenteral (2).

In context

MeasurePhenylbutazoneAll horse reportsAll reports
Reports21918,3821,357,245
Share of that pool's reports naming this drug—0.8%0%
Classed serious, of reports stating it64.4%44.1%38.6%
Death or euthanasia recorded, per 1,000 reports223.713663.8
Filed as lack of expected effectiveness (wholly or partly)2.7%—23%
Top term, share of reportsDeath 11.9%8.1%—

This set accounts for 100% of all reports naming phenylbutazone, so no separate ingredient column is shown. 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.

FDA-approved products containing phenylbutazone (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
Butazolidin Bolus; Butazolidin TabletsPhenylbutazoneIntervet, Inc.Dogs, HorsesNADA 010-987
Butazolidin Injectable 20%PhenylbutazoneIntervet, Inc.Dogs, HorsesNADA 011-575
Butazolidin GranulesPhenylbutazoneIntervet, Inc.HorsesNADA 038-800
ButatronPhenylbutazoneBimeda Animal Health Ltd.Dogs, HorsesNADA 044-756
Tevcodyne InjectablePhenylbutazoneElanco US Inc.Dogs, HorsesNADA 045-416
EquiBute InjectionPhenylbutazoneZoetis Inc.Dogs, HorsesNADA 045-514
EquiBute Tablets 100 mgPhenylbutazoneZoetis Inc.Dogs, HorsesNADA 045-515
Phen-Buta Vet InjectionPhenylbutazoneBimeda Animal Health Ltd.HorsesNADA 046-780
Bizolin-100; Bizolin-200PhenylbutazoneCronus Pharma Specialities India Private Ltd.Dogs, HorsesNADA 047-712
Phen-Buta Vet Tablets; Phenylbutazone Tablets (Horses)PhenylbutazoneBimeda Animal Health Ltd.HorsesNADA 049-187
Robizone-VPhenylbutazoneZoetis Inc.Dogs, HorsesNADA 091-065
Phenylbutazone Tablets, USP 1 gramPhenylbutazoneElanco US Inc.HorsesNADA 091-818
Robizone-VPhenylbutazoneZoetis Inc.HorsesNADA 093-105
Bizolin Injection 20%PhenylbutazoneCronus Pharma Specialities India Private Ltd.HorsesNADA 093-516
Phenylbutazone Tablets, USP 100 mg; Phenylbutazone Tablets, USP 200 mgPhenylbutazoneCronus Pharma Specialities India Private Ltd.DogsNADA 094-170
Phen-Buta-Vet InjectionPhenylbutazoneBimeda Animal Health Ltd.DogsNADA 096-671
Phen-Buta-Vet Tablets; Phenylbutazone S/APhenylbutazoneBimeda Animal Health Ltd.DogsNADA 096-672
Robizone Injectable 20%PhenylbutazoneZoetis Inc.Dogs, HorsesNADA 098-640
Bizolin 1-GPhenylbutazoneCronus Pharma Specialities India Private Ltd.Dogs, HorsesNADA 099-618
EquipalazonePhenylbutazoneVetoquinol N.-A., Inc.HorsesNADA 113-510
Butazolidin; Butazolidin Paste; Bute; Phenylbute Paste; Phenylzone PastePhenylbutazoneIntervet, Inc.HorsesNADA 116-087
Butatron GelPhenylbutazoneBimeda Animal Health Ltd.HorsesNADA 118-979
Phenylbutazone 20% InjectionPhenylbutazoneElanco US Inc.HorsesANADA 200-126
ButequinePhenylbutazoneVetoquinol USA, Inc.HorsesANADA 200-266
SuperiorbutePhenylbutazoneNoble Pharma, LLCHorsesANADA 200-333
Equizone 100PhenylbutazoneA & G Pharmaceuticals, Inc.HorsesANADA 200-334
Phenylbutazone 20% InjectionPhenylbutazoneSparhawk Laboratories, Inc.HorsesANADA 200-371
PributazonePhenylbutazoneFirst Priority, Inc.HorsesANADA 200-433
Phenylbutazone Injectionapproval voluntarily withdrawnPhenylbutazoneWatson Laboratories, Inc.—NADA 045-848
Phenylbutazone Injectableapproval voluntarily withdrawnPhenylbutazoneWatson Laboratories, Inc.—NADA 048-391
Therazone Injectionapproval voluntarily withdrawnPhenylbutazoneFirst Priority, Inc.HorsesNADA 048-646
Phenylbutazon Boluses; Therazone Tabletsapproval voluntarily withdrawnPhenylbutazoneFirst Priority, Inc.HorsesNADA 048-647
Phenylbutazone Injectionapproval voluntarily withdrawnPhenylbutazoneAkorn, Inc.—NADA 094-978
Phenylbutazone Tabletsapproval voluntarily withdrawnPhenylbutazonePegasus Laboratories, Inc.Dogs, HorsesNADA 102-824
Equiphen Pasteapproval voluntarily withdrawnPhenylbutazoneLuitpold Pharmaceuticals, Inc.HorsesNADA 140-958
Phenylbutazone Tabletsapproval voluntarily withdrawnPhenylbutazoneHikma International Pharmaceuticals LLC (Exempt Company)HorsesANADA 200-323

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 phenylbutazone reports

How many adverse event reports has FDA received for phenylbutazone?

219 reports record a drug with phenylbutazone as its active ingredient in the openFDA release of 28 Sep 2026, covering reports received through March 2026. 17 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 36 approved applications with this ingredient alone; the reference list on this page names them without any counts.

What signs are reported most often?

death (11.9%), death by euthanasia (8.7%), diarrhoea (8.2%), anorexia (7.8%) and colic (7.8%). 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?

horse (66.7%), dog (8.2%) and cat (0.9%). Among single-breed animals the most frequent labels are Quarter Horse, Thoroughbred, Arab and Warmblood; popular breeds appear often in any drug's reports because there are more of them.

Are reports rising?

17 reports in the 12 months to March 2026, up 89% from 9 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 phenylbutazone 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 phenylbutazone?

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.