Pet Drug Reports

Drugs by active ingredient

Drug · single active ingredient

Oxytetracycline Hydrochloride: adverse event reports

All products with this active ingredient · 27 FDA-approved applications in the Green Book

432reports naming this ingredient, 1987–20220% of all reports · about 11 a year
0reports, 12 months to March 20260 in the 12 months before
50%classed serious, as reportedof 10 reports stating it
15%record death or euthanasia, as reported65 reports
32.6%of reports concern chickens13.1% of all chicken reports

Between January 1987 and August 2022 FDA received 432 adverse event reports listing a drug with oxytetracycline hydrochloride as the recorded active ingredient. The Green Book lists 27 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, 0 reports named it, and none 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 11 reports a year and 0% of all 1,357,245 reports (13.1% of all chicken reports). How many animals received it is not published, so a count says nothing about how often a problem occurs per dose.

The signs named most often are no sign (21.8%), color, Abnormal (14.8%) and death (13.4%). A report can list several signs, so shares add to more than 100%; 118 different terms appear across these reports.

32.6% of reports concern chickens. Not every report describes illness: 32.9% as product or packaging defects. Of reports that state seriousness, 50% were classed as serious, and 15% 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
Cat1 · peak 1
May 2021: 12022202320242025
Horse1 · peak 1
May 2021: 12022202320242025
Other2 · peak 1
Jun 2022: 1Aug 2022: 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

037731987: 119871988: 11989: 11990: 419901991: 31992: 51993: 219931994: 61995: 61996: 419961997: 131998: 241999: 2719992000: 232001: 102002: 720022003: 122004: 202005: 2620052006: 512007: 732008: 5620082009: 192010: 82011: 420112012: 72013: 12014: 320142015: 12016: 42017: 220172018: 22019: 22021: 220212022: 2

2022 covers reports received through March 2026 only.

Signs listed in reports

share of oxytetracycline hydrochloride reports listing the termall chicken reports

  1. No sign[no clinical sign was reported]21.8%94
  2. Color, Abnormal[a product quality report, not a sign in an animal]14.8%64
  3. Death13.4%58
  4. Lack of efficacy (bacteria) - NOS[the product did not have the expected effect: target not specified]7.9%34
  5. Residues in eggs7.6%33
  6. Accidental exposure[exposure that was not intended]5.8%25
  7. Seal, Abnormal[a product quality report, not a sign in an animal]5.8%25
  8. Solution, Abnormal[a product quality report, not a sign in an animal]4.6%20
  9. Unclassifiable adverse event[event that fits no dictionary term]4.6%20
  10. Odor, Abnormal[a product quality report, not a sign in an animal]4.4%19
  11. Containers, Damaged[a product quality report, not a sign in an animal]3.9%17
  12. Anaphylaxis[sudden severe allergic-type reaction]3.2%14
  13. Collapse2.5%11
  14. Vials, Leaking[a product quality report, not a sign in an animal]2.3%10
  15. Product Defect, General[a product quality report, not a sign in an animal]2.1%9
  16. Recumbency[lying down and unable or unwilling to rise]1.9%8
  17. Suspension, Abnormal[a product quality report, not a sign in an animal]1.9%8
  18. Injection site pain[pain where the injection was given]1.6%7
  19. Lack of efficacy - NOS[the product did not have the expected effect]1.6%7
  20. Diarrhoea[diarrhea]1.4%6
  21. Dyspnoea[difficulty breathing]1.2%5
  22. Underfilling, Package[a product quality report, not a sign in an animal]1.2%5
  23. Contamination NOS[NOS: not otherwise specified]0.9%4
  24. Hypersalivation[drooling]0.9%4
  25. Injection site swelling[swelling where the injection was given]0.9%4

Top 30 of 118 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/Normal1.4%6
Recovered with Sequela0%0
Ongoing0.2%1
Died15%65
Euthanized0%0
Outcome Unknown1.2%5

What kind of report it was

Safety issue66.2%286
Lack of expected effectiveness0.7%3
Both safety and lack of expected effectiveness0.2%1
Manufacturing or product defect32.9%142
Other0%0

Coloured bar: reports naming oxytetracycline hydrochloride. 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

Chicken32.6%141
Cattle13.7%59
Human exposure5.8%25
Other Birds3.9%17
Other1.9%8
Sheep1.9%8

Single-breed animals

Jersey0.7%3
Maltese0.5%2
Domestic0.2%1

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 year15%65
1 to 3 years7.4%32
4 to 7 years3.2%14
8 to 11 years0.2%1
12 years and over1.4%6
Age not given72.7%314

Weight of the animal

Under 5 kg (11 lb)9.3%40
5 to 9.9 kg (11–22 lb)0.9%4
10 to 24.9 kg (22–55 lb)1.9%8
25 to 44.9 kg (55–99 lb)0.7%3
45 kg and over (99 lb+)10%43
Weight not given77.3%334

Route of administration stated in reports: oral (213), intramuscular (19), intravenous (19), topical (7), subcutaneous (5), ophthalmic (2).

In context

MeasureOxytetracycline HydrochlorideAll chicken reportsAll reports
Reports4321,0731,357,245
Share of that pool's reports naming this drug—13.1%0%
Classed serious, of reports stating it50%58.2%38.6%
Death or euthanasia recorded, per 1,000 reports150.552463.8
Filed as lack of expected effectiveness (wholly or partly)0.9%—23%
Top term, share of reportsNo sign 21.8%7.5%—

This set accounts for 98.9% of all reports naming oxytetracycline hydrochloride, 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 oxytetracycline hydrochloride (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
Terramycin Vet CapsulesOxytetracycline HydrochlorideZoetis Inc.Dogs, CatsNADA 007-879
TERRAMYCIN-343; Terramycin; Terramycin Soluble Powder ConcentrateOxytetracycline HydrochloridePhibro Animal Health Corp.Cattle, Swine, Chickens, Turkeys, SheepNADA 008-622
Liquamycin Injectable; Terramycin InjectableOxytetracycline HydrochlorideZoetis Inc.Cattle, Swine, Chickens, TurkeysNADA 008-769
TM-50; TM-50 D; TM-100; TM-100DOxytetracycline HydrochloridePhibro Animal Health Corp.Cattle, Swine, Chickens, Turkeys, SheepNADA 008-804
Terramycin Scours TabletsOxytetracycline HydrochlorideZoetis Inc.CattleNADA 011-060
OXY WSOxytetracycline HydrochloridePhibro Animal Health Corp.Chickens, TurkeysNADA 038-200
Oxytetracycline-50Oxytetracycline HydrochlorideHuvepharma EOODCattleNADA 048-287
Rachelle Oxyvet InjectionOxytetracycline HydrochlorideZoetis Inc.CattleNADA 091-127
Liquamycin 100; Terramycin 100Oxytetracycline HydrochlorideZoetis Inc.Cattle, SwineNADA 094-114
Aquachel-100; Oxyvet-100Oxytetracycline HydrochlorideZoetis Inc.CattleNADA 099-402
OXYMarine; Oxytet SolubleOxytetracycline HydrochlorideHuvepharma EOODSwine, Chickens, TurkeysNADA 130-435
Biocyl-50; Biocyl-100Oxytetracycline HydrochlorideBimeda Animal Health Ltd.CattleNADA 140-582
Pennox 343Oxytetracycline HydrochloridePharmgate Inc.Cattle, Swine, Chickens, Turkeys, SheepANADA 200-026
AGRIMYCIN-343Oxytetracycline HydrochlorideHuvepharma EOODSwine, Chickens, TurkeysANADA 200-066
Tetroxy HCA-280; Tetroxy HCA-1772; Tetroxy HCA-1400Oxytetracycline HydrochlorideBimeda Animal Health Ltd.Swine, Chickens, TurkeysANADA 200-144
Tetroxy 25Oxytetracycline HydrochlorideBimeda Animal Health Ltd.Cattle, Swine, Chickens, Turkeys, SheepANADA 200-146
Tetroxy 343Oxytetracycline HydrochlorideBimeda Animal Health Ltd.Cattle, Swine, Chickens, Turkeys, SheepANADA 200-247
Tetroxy AquaticOxytetracycline HydrochlorideBimeda Animal Health Ltd.—ANADA 200-460
Terramycin Egg Formulaapproval voluntarily withdrawnOxytetracycline HydrochloridePfizer, Inc.—NADA 010-661
Liquimast Solution for Mastitisapproval voluntarily withdrawnOxytetracycline HydrochloridePfizer, Inc.—NADA 011-034
TM-10 Premixapproval voluntarily withdrawnOxytetracycline HydrochloridePfizer, Inc.—NADA 013-470
Oxytetracycline Premixapproval voluntarily withdrawnOxytetracycline HydrochloridePurina Mills, Inc.—NADA 094-959
Purina Mix-R-Mycin Concentrateapproval voluntarily withdrawnOxytetracycline HydrochloridePurina Mills, Inc.—NADA 094-960
Bio-Mycin C; Oxy-Tet Injectionapproval voluntarily withdrawnOxytetracycline HydrochlorideBoehringer Ingelheim Animal Health USA Inc.Cattle, SwineNADA 095-642
Terramycin Premixapproval voluntarily withdrawnOxytetracycline HydrochloridePfizer, Inc.ChickensNADA 103-758
OXY 1000 Calf Bolus; OXY 500 Calf Bolusapproval voluntarily withdrawnOxytetracycline HydrochlorideBoehringer Ingelheim Animal Health USA Inc.CattleNADA 141-002
Oxytetracycline Hydrochloride Soluble Powderapproval voluntarily withdrawnOxytetracycline HydrochlorideVetoquinol N.-A., Inc.Swine, Chickens, TurkeysANADA 200-305

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 oxytetracycline hydrochloride reports

How many adverse event reports has FDA received for oxytetracycline hydrochloride?

432 reports record a drug with oxytetracycline hydrochloride as its active ingredient in the openFDA release of 28 Sep 2026, covering reports received through March 2026. 0 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 27 approved applications with this ingredient alone; the reference list on this page names them without any counts.

What signs are reported most often?

no sign (21.8%), color, Abnormal (14.8%), death (13.4%), granules/Powder, Abnormal (8.6%) and lack of efficacy (bacteria) - NOS (7.9%). 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?

chicken (32.6%), cattle (13.7%) and human exposure (5.8%). Among single-breed animals the most frequent labels are Holstein-Friesian, Aberdeen Angus, Charolais and Jersey; popular breeds appear often in any drug's reports because there are more of them.

Are reports rising?

0 reports in the 12 months to March 2026, and none 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 oxytetracycline hydrochloride 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 oxytetracycline hydrochloride?

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.