Species
Fish: adverse event reports
208 reports, 0% of FDA's animal drug adverse event database
208 adverse event reports in FDA's database concern fish: 0% of all reports received from May 1989 to July 2025. 2 arrived in the 12 months to March 2026, close to the 2 of the 12 months before. That is 0% of all reports received in those 12 months and about 6 reports a year over the whole record.
By active ingredient, the drugs named most often are opafp-ghc2 rdna construct (46.6% of fish reports), florfenicol (32.2% of fish reports), moxidectin (1.4% of fish reports) and oxytetracycline hydrochloride (1.4% of fish reports). Drugs given to the most animals lead the list for that reason; brands are masked in the public data.
The terms listed most often are death (54.3%), iGA Animal mortality greater than expected (19.7%) and fish body deformity (15.4%). 87.7% of reports stating seriousness were classed as serious (38.6% across all species), and 79.8% record a death or euthanasia (6.4% overall).
FDA posts reports quarterly with a delay of three to six months, so the newest months are incomplete and usually grow in later releases.
Drugs named most often, by active ingredient
| Active ingredients recorded for the drug | Reports | Share of fish reports | Share of the drug's reports that concern fish |
|---|---|---|---|
| opAFP-GHc2 rDNA construct | 97 | 46.6% | 99% |
| Florfenicol | 67 | 32.2% | 6.2% |
| Moxidectin | 3 | 1.4% | 0% |
| Oxytetracycline Hydrochloride | 3 | 1.4% | 0.7% |
| Amprolium | 2 | 1% | 0.5% |
| Carprofen | 2 | 1% | 0% |
| Doramectin | 2 | 1% | 0% |
| Enrofloxacin | 2 | 1% | 0% |
| Monensin | 2 | 1% | 0% |
| Moxidectin + Praziquantel | 2 | 1% | 0.4% |
| Ormetoprim + Sulfadimethoxine | 2 | 1% | 0.2% |
| Selamectin | 2 | 1% | 0% |
| Sulfadiazine + Trimethoprim | 2 | 1% | 0.7% |
| Tildipirosin | 2 | 1% | 0.4% |
| Amitraz | 1 | 0.5% | 0.1% |
| Ceftiofur Crystalline Free Acid | 1 | 0.5% | 0% |
| Chorionic Gonadotropin | 1 | 0.5% | 2.9% |
| Eprinomectin | 1 | 0.5% | 0% |
| Fenbendazole | 1 | 0.5% | 0% |
| Isoflurane | 1 | 0.5% | 0% |
| Lasalocid sodium | 1 | 0.5% | 0.4% |
| Lufenuron | 1 | 0.5% | 0% |
| Milbemycin Oxime + Spinosad | 1 | 0.5% | 0% |
| Pentobarbital Sodium + Phenytoin Sodium | 1 | 0.5% | 0.2% |
| Tetracycline Hydrochloride | 1 | 0.5% | 1.5% |
Ordered by report count, which follows how widely a drug is used. 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". openFDA masks brand and manufacturer names in adverse event records, so the reports counted here cannot be attributed to a particular brand.
Signs listed in reports
share of fish reports listing the termall species
- Death54.3%113
- IGA Animal mortality greater than expected19.7%41
- Fish body deformity15.4%32
- Lack of efficacy (bacteria) - NOS[the product did not have the expected effect: target not specified]14.9%31
- Moribund11.5%24
- Death by euthanasia[the animal was euthanized]8.7%18
- IGA Animal morbidity greater than expected8.2%17
- Skin lesion NOS[NOS: not otherwise specified]6.7%14
- Accidental exposure[exposure that was not intended]4.3%9
- Lack of efficacy - NOS[the product did not have the expected effect]3.8%8
- Anorexia[not eating]3.4%7
- Photosensitization2.4%5
- No sign[no clinical sign was reported]1.9%4
- Sunburn1.9%4
- Skin slough1.4%3
- Depression[dull, quiet or withdrawn]1%2
- Dropsy1%2
- Fungal skin infection NOS[NOS: not otherwise specified]1%2
- Ineffective, other drug(s)[legacy FDA term: the product did not have the expected effect (other drug(s))]1%2
- NT - Abnormal necropsy finding NOS[NOS: not otherwise specified]1%2
- PR-skin, lesion(s)[legacy FDA term: lesions found in the skin]1%2
- Skin hyperaemia[reddened skin]1%2
- Weakness1%2
- Abdominal mass0.5%1
- Abnormal breathing0.5%1
- Abnormal swimming in fish0.5%1
- Anal prolapse0.5%1
Single ingredients, pooled across combinations
- opAFP-GHc2 rDNA construct97 reports · 46.6%
- Florfenicol67 reports · 32.2%
- Moxidectin5 reports · 2.4%
- Oxytetracycline Hydrochloride3 reports · 1.4%
- Amprolium2 reports · 1%
- Carprofen2 reports · 1%
- Doramectin2 reports · 1%
- Enrofloxacin2 reports · 1%
- Monensin2 reports · 1%
- Ormetoprim2 reports · 1%
- Praziquantel2 reports · 1%
- Selamectin2 reports · 1%
- Sulfadiazine2 reports · 1%
- Sulfadimethoxine2 reports · 1%
- Tildipirosin2 reports · 1%
- Trimethoprim2 reports · 1%
Age and weight
Age of the animal
Weight of the animal
Outcomes and report types
Outcome recorded in the report
What kind of report it was
Coloured bar: fish reports. Grey bar: all 1,357,245 reports. Outcomes are as stated by the reporter.
Trend
Reports by month FDA received them. The newest months are incomplete because FDA posts reports with a delay of three to six months.
| Measure | Fish | All reports |
|---|---|---|
| Reports | 208 | 1,357,245 |
| Classed serious, of reports stating it | 87.7% | 38.6% |
| Death or euthanasia recorded, per 1,000 reports | 798.1 | 63.8 |
| Filed as lack of expected effectiveness (wholly or partly) | 6.7% | 23% |
Questions about fish reports
How many adverse event reports involve fish?
208 reports through March 2026, 0% of the database; 2 in the latest 12 months.
Which drugs are reported most often for fish?
By active ingredient: opafp-ghc2 rdna construct (97), florfenicol (67), moxidectin (3), oxytetracycline hydrochloride (3) and amprolium (2). The order tracks how widely each is used; brands are masked in the public data.
What signs are reported most in fish?
death (54.3%), iGA Animal mortality greater than expected (19.7%), fish body deformity (15.4%), lack of efficacy (bacteria) - NOS (14.9%) and moribund (11.5%).
What ages are the fish in these reports?
under 1 year (43.3%), 1 to 3 years (9.6%) and 4 to 7 years (2.4%); age is not given in 43.3% of reports.
Do more reports mean more risk for this species?
No. Counts follow how many animals are treated and how readily their owners and veterinarians report. 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."
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. 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.