Drug · single active ingredient
Oxytetracycline: adverse event reports
All products with this active ingredient · 16 FDA-approved applications in the Green Book
- Mostly cattle reports
- Subcutaneous route most often
- Brands masked by FDA
FDA has received 1,241 adverse event reports in which a drug is recorded with oxytetracycline as its active ingredient, from April 1987 to February 2026. The Green Book lists 16 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, 15 reports named it, up 67% 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. Over its whole reporting history that is about 32 reports a year and 0.1% of all 1,357,245 reports (2.1% of all cattle 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 (27.9%), solution, Abnormal (15.1%) and anaphylaxis (14.6%). A report can list several signs, so shares add to more than 100%; 485 different terms appear across these reports. Death appears in 27.9% of these reports, a larger share than in the pooled reports for every drug containing oxytetracycline (21.1%).
52.1% of reports concern cattle. Not every report describes illness: 30.6% as product or packaging defects. Of reports that state seriousness, 70.7% were classed as serious, and 32.3% 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 oxytetracycline reports listing the termall drugs containing oxytetracyclineall cattle reports
- Death27.9%346
- Solution, Abnormal[a product quality report, not a sign in an animal]15.1%187
- Anaphylaxis[sudden severe allergic-type reaction]14.6%181
- Injection site swelling[swelling where the injection was given]11.2%139
- Color, Abnormal[a product quality report, not a sign in an animal]10.5%130
- Lack of efficacy (bacteria) - NOS[the product did not have the expected effect: target not specified]8.8%109
- Collapse6.8%84
- Dyspnoea[difficulty breathing]5.2%64
- Hypersalivation[drooling]4.1%51
- Unclassifiable adverse event[event that fits no dictionary term]3.2%40
- Recumbency[lying down and unable or unwilling to rise]3%37
- Injection site pain[pain where the injection was given]2.9%36
- Accidental exposure[exposure that was not intended]2.7%33
- Anorexia[not eating]2.3%28
- Residues in milk2.3%28
- Vials, Leaking[a product quality report, not a sign in an animal]2.2%27
- Death by euthanasia[the animal was euthanized]2%25
- Depression[dull, quiet or withdrawn]2%25
- Lameness1.9%24
- Vials, Damaged[a product quality report, not a sign in an animal]1.9%23
- Fever1.8%22
- Lack of efficacy - NOS[the product did not have the expected effect]1.8%22
- No sign[no clinical sign was reported]1.8%22
- Injection site abscess[abscess where the injection was given]1.7%21
- PR-lung(s), lesion(s)[legacy FDA term: lesions found in the lungs]1.7%21
- Seal, Abnormal[a product quality report, not a sign in an animal]1.6%20
- Ataxia[unsteady, uncoordinated movement]1.5%19
- Counterfeit product1.5%19
- Death-treatment failure1.3%16
- Staggering1.3%16
Top 30 of 485 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 oxytetracycline. 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: subcutaneous (321), intramuscular (271), intravenous (39), ophthalmic (21), oral (11), other (11).
In context
| Measure | Oxytetracycline | All drugs containing oxytetracycline | All cattle reports | All reports |
|---|---|---|---|---|
| Reports | 1,241 | 1,826 | 31,229 | 1,357,245 |
| Share of that pool's reports naming this drug | — | 68% | 2.1% | 0.1% |
| Classed serious, of reports stating it | 70.7% | 58.3% | 58.4% | 38.6% |
| Death or euthanasia recorded, per 1,000 reports | 323.1 | 255 | 368 | 63.8 |
| Filed as lack of expected effectiveness (wholly or partly) | 2.2% | — | — | 23% |
| Top term, share of reports | Death 27.9% | 21.1% | 29.4% | — |
The oxytetracycline pool is every report naming oxytetracycline alone or in any combination; this single-ingredient set accounts for 68% 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 |
|---|---|---|
| Oxytetracycline + Polymyxin B Sulfate | 386 | 17 |
| Oxytetracycline + Oxytetracycline Dihydrate | 165 | 4 |
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 oxytetracycline (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 |
|---|---|---|---|---|
| Oxyject | Oxytetracycline | Cronus Pharma Specialities India Private Ltd. | Cattle | NADA 045-143 |
| Bio-Mycin; OXY-TET 50 | Oxytetracycline | Cronus Pharma Specialities India Private Ltd. | Cattle, Swine | NADA 047-278 |
| Terramycin 10; Terramycin 30; Terramycin 50; Terramycin 100; Terramycin 200; Terramycin 200 Granular; Terramycin 100MR | Oxytetracycline | Phibro Animal Health Corp. | Cattle, Swine, Chickens, Turkeys, Sheep | NADA 095-143 |
| Oxyject 100; Status SQ | Oxytetracycline | Cronus Pharma Specialities India Private Ltd. | Cattle, Swine | NADA 097-452 |
| Medamycin 100; Medamycin | Oxytetracycline | Cronus Pharma Specialities India Private Ltd. | Cattle | NADA 108-963 |
| Liquamycin LA-200 | Oxytetracycline | Zoetis Inc. | Cattle, Swine | NADA 113-232 |
| Pennox 50; Pennox 100-MR; Pennox 100 Hi-Flo; Pennox 200 Hi-Flo | Oxytetracycline | Pharmgate Inc. | Cattle, Swine, Chickens, Turkeys, Sheep | NADA 138-938 |
| Bio-Mycin 200 | Oxytetracycline | Boehringer Ingelheim Animal Health USA, Inc. | Cattle, Swine | ANADA 200-008 |
| Maxim 100 | Oxytetracycline | Huvepharma EOOD | Cattle | ANADA 200-068 |
| Oxytetracycline Injection | Oxytetracycline | Bimeda Animal Health Ltd. | Cattle, Swine | ANADA 200-117 |
| MAXIM-200 | Oxytetracycline | Huvepharma EOOD | Cattle, Swine | ANADA 200-123 |
| Pennox 200 | Oxytetracycline | Pharmgate Inc. | Cattle, Swine | ANADA 200-154 |
| Oxytetracycline Injection 200 | Oxytetracycline | Norbrook Laboratories, Ltd. | Cattle, Swine | ANADA 200-306 |
| Oxytet 100 | Oxytetracycline | Norbrook Laboratories, Ltd. | Cattle | ANADA 200-452 |
| Tetroxy-LA | Oxytetracycline | Bimeda Animal Health Ltd. | Cattle, Swine | ANADA 200-537 |
| Geomycin 200approval voluntarily withdrawn | Oxytetracycline | Pliva, d. d. | Cattle, Swine | ANADA 200-232 |
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 reports
How many adverse event reports has FDA received for oxytetracycline?
1,241 reports record a drug with oxytetracycline as its active ingredient in the openFDA release of 28 Sep 2026, covering reports received through March 2026. 15 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 16 approved applications with this ingredient alone; the reference list on this page names them without any counts.
What signs are reported most often?
death (27.9%), solution, Abnormal (15.1%), anaphylaxis (14.6%), injection site swelling (11.2%) and color, Abnormal (10.5%). 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?
cattle (52.1%), horse (3.4%) and human exposure (3.2%). Among single-breed animals the most frequent labels are Holstein-Friesian, Aberdeen Angus, Hereford cattle and Domestic Shorthair; popular breeds appear often in any drug's reports because there are more of them.
Are reports rising?
15 reports in the 12 months to March 2026, up 67% 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 oxytetracycline 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?
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.