Diclazuril (Protazil, Clinacox 0.2%): adverse event reports that FDA received
Active ingredient
The names in brackets are brand names with this active ingredient.
The openFDA records give the value "MSK" for the brand name and for the manufacturer name of each drug. FDA says that MSK means "masked". So the site cannot count a report for a brand.
Read this first. FDA says this about the data:
An API dataset query result cannot be used to estimate the risk associated with the product or compare one drug or device product with another. When looking at the results, be aware that there is no certainty that the reported drug or device caused the adverse event. This dataset should not be the sole source of information for clinical decision-making or other assumptions about the safety or effectiveness of a product. The adverse event may have been related to an underlying disease, other drugs used at the same time or other non-drug related sources.
FDA Center for Veterinary Medicine publishes these words. Source: Adverse Event Reports for Animal Drugs and Devices, read on . The data have the reports that FDA received through .
This page is not veterinary advice. For an animal that is ill, speak to a veterinarian.
Contacting a veterinarianHow to report to FDAFrom August 2000 to June 2026, FDA received 181 adverse event reports that name a drug with diclazuril as its active ingredient. Of the 181 reports, 75 (41.4%) are about horses. 5 reports are about chickens (2.8%).
In January to March 2026, FDA received 2 reports that name this drug. The signs that appear in the largest number of the 181 reports are "Lack of efficacy (protozoa) - NOS" and "Containers, Damaged". A report is not proof that a drug caused a sign.
Reports that name this drug fell by 18.2% in the 12 months to June 2026, compared with the 12 months before. Reports for all animal drugs fell by 4.6% in the same periods. The newest months can get more reports in a later update. Reports about horses are 41.4% of the reports that name this drug, and 1.4% of all reports.
Search engines list a drug page with 500 reports or more in all years. The page also needs 30 reports or more in the 12 months to June 2026. This page is under one of these numbers. The site keeps the page and keeps it out of search engines.
Since the last update of the FDA data
The latest update of the FDA data, recorded on , changed no count of this page.
January to March 2026 is the latest closed quarter in the data. In that quarter FDA received 2 reports that name diclazuril: 0 dog, 0 cat, 0 horse, 2 other or not given.
Signs that the reports list
A sign is a coded term from the report. The words in brackets are a plain gloss of the term. The percentage is the share of the 181 reports that list the sign. One report can list more than one sign.
The sign that is in the largest number of the reports comes first.
- Lack of efficacy (protozoa) - NOS[the product did not have the expected effect: target not specified]17.1%31 reports
- Containers, Damaged[a product quality report, not a sign in an animal]14.4%26 reports
- Underfilling, Container[a product quality report, not a sign in an animal]9.4%17 reports
- Closure, Abnormal[a product quality report, not a sign in an animal]8.8%16 reports
- Underfilling, Package[a product quality report, not a sign in an animal]7.7%14 reports
- Defect Unknown/Not Specified[a product quality report, not a sign in an animal]5.5%10 reports
- Containers, Abnormal[a product quality report, not a sign in an animal]5%9 reports
- Death by euthanasia[the animal was euthanized]4.4%8 reports
- Underfilling, Buckets/Pails[a product quality report, not a sign in an animal]4.4%8 reports
- Lack of efficacy - NOS[the product did not have the expected effect]3.9%7 reports
- Drug administration duration too long3.3%6 reports
- Uncoded sign[a sign with no matching dictionary term]3.3%6 reports
- Diarrhoea[diarrhea]2.8%5 reports
- Product Defect, General[a product quality report, not a sign in an animal]2.8%5 reports
Show the next 16 signs
- Product defect, product difficult to use/handle[a product quality report, not a sign in an animal]2.8%5 reports
- Weight loss2.8%5 reports
- Appearance, Abnormal[a product quality report, not a sign in an animal]2.2%4 reports
- Behavioural disorder NOS[behaviour change, type not specified]2.2%4 reports
- Colic2.2%4 reports
- Hives2.2%4 reports
- Lack of efficacy (endoparasite) - NOS[the product did not have the expected effect: target not specified]2.2%4 reports
- Recumbency[lying down and unable or unwilling to rise]2.2%4 reports
- Unpalatable[legacy FDA term: the animal would not take it]2.2%4 reports
- Administration device NOS, abnormal1.7%3 reports
- Ataxia[unsteady, uncoordinated movement]1.7%3 reports
- Fever1.7%3 reports
- Granules/Powder, Abnormal1.7%3 reports
- Inappetence[reduced appetite]1.7%3 reports
- Inappropriate schedule of drug administration1.7%3 reports
- Increased mortality rate1.7%3 reports
The list shows 30 of 128 coded signs. A report is not proof that a drug caused a sign. Download all signs (CSV)
Reports by species
The share is of all 181 reports that name diclazuril. The other reports give a different species or no species.
Reports for each month, Jul 2021 to Jun 2026
No chart: no month has 5 or more reports.
No chart: no month has 5 or more reports.
No chart: no month has 5 or more reports.
The month is the month in which FDA received the report. Each chart has its own scale. FDA says that a report can take 3 to 6 months to reach the public data. The newest months can get more reports in a later update.
Reports by year
- Dog
- Cat
- Horse
- Other or not given
| Year | Dog | Cat | Horse | Other or not given | All species |
|---|---|---|---|---|---|
| 2026 | 0 | 0 | 3 | 2 | 5 |
| 2025 | 0 | 0 | 8 | 15 | 23 |
| 2024 | 0 | 0 | 12 | 15 | 27 |
| 2023 | 0 | 0 | 9 | 12 | 21 |
| 2022 | 1 | 0 | 11 | 9 | 21 |
| 2021 | 0 | 0 | 6 | 5 | 11 |
| 2020 | 0 | 0 | 7 | 9 | 16 |
| 2019 | 0 | 0 | 2 | 1 | 3 |
| 2018 | 0 | 0 | 5 | 3 | 8 |
| 2017 | 0 | 0 | 6 | 5 | 11 |
| 2016 | 0 | 0 | 1 | 2 | 3 |
| 2015 | 0 | 0 | 1 | 3 | 4 |
| 2014 | 0 | 0 | 1 | 8 | 9 |
| 2013 | 0 | 0 | 0 | 6 | 6 |
| 2012 | 0 | 0 | 2 | 5 | 7 |
| 2011 | 0 | 0 | 1 | 0 | 1 |
| 2006 | 0 | 0 | 0 | 1 | 1 |
| 2004 | 0 | 0 | 0 | 2 | 2 |
| 2001 | 0 | 0 | 0 | 1 | 1 |
| 2000 | 0 | 0 | 0 | 1 | 1 |
2026 has the reports that FDA received through Jun 2026. Download the years (CSV)
What the reports record
Outcome at the time of the report
- Recovered/Normal6.1%11
- Recovered with Sequela[recovered, with a lasting effect]0%0
- Ongoing32%58
- Died3.3%6
- Euthanized4.4%8
- Outcome Unknown2.8%5
An outcome in a report is not proof that the drug caused it. The person who sends the report gives the outcome. Each share is of the 181 reports that name diclazuril.
A report about more than one animal can have more than one outcome.
Kind of report
- Safety issue24.3%44
- Lack of expected effectiveness7.7%14
- Both safety and lack of expected effectiveness15.5%28
- Manufacturing or product defect52.5%95
- Other0%0
83 reports say if the event was serious. 77.1% of them have the serious flag. The person who sends the report sets the flag.
Show age, weight, breed and route
Age of the animal
- Under 1 year3.3%6
- 1 to 3 years1.1%2
- 4 to 7 years4.4%8
- 8 to 11 years6.6%12
- 12 years and over27.1%49
- Age not given57.5%104
Weight of the animal
- Under 5 kg (11 lb)0%0
- 5 to 9.9 kg (11 to 22 lb)0%0
- 10 to 24.9 kg (22 to 55 lb)0%0
- 25 to 44.9 kg (55 to 99 lb)0.6%1
- 45 kg and over (99 lb and over)27.1%49
- Weight not given72.4%131
Breed, where the report gives one breed
- Quarter Horse8.3%15
- Warmblood5.5%10
- Thoroughbred3.9%7
- Appaloosa1.1%2
- Arab1.1%2
- Hanovarian1.1%2
- Irish Hunter1.1%2
- Tennessee Walking Horse1.1%2
A breed with many animals has many reports.
Route in the report
- Oral45.3%82
- Intravenous0.6%1
Each bar is on a scale of 0 to 100%.
Approved animal drugs with this active ingredient (FDA Green Book)
This section is reference data. It has no report count.
The openFDA records give the value "MSK" for the brand name and for the manufacturer name of each drug. FDA says that MSK means "masked". So the site cannot count a report for a brand.
Brand names
- Protazil
- Clinacox 0.2%
What the Green Book records give
- Applications with an approval in force
- 2
- Approved species
- Chickens, Equids, Turkeys
- Dose forms
- Medicated Feed, Pellet
- Routes
- Oral
- Sale
- OTC (over the counter), RX (prescription)
- Earliest approval date in the records
The species, dose forms and routes are the words of the Green Book records for all the applications together. One product can have fewer. The label of a product gives its approved use.
| Brand name | Active ingredients | Sponsor | Approved species | Application |
|---|---|---|---|---|
| Clinacox 0.2% | Diclazuril | Elanco US Inc. | Chickens, Turkeys | NADA 140-951 |
| Protazil | Diclazuril | Intervet, Inc. | Horses | NADA 141-268 |
Next in the A to Z list
FDA pages for this drug
- How to Report Animal Drug and Device Side Effects and Product ProblemsThe FDA page that tells an owner or a veterinarian how to send a report.
- Green Book record of NADA 141-268The FDA record of the application for Protazil.
- Green Book record of NADA 140-951The FDA record of the application for Clinacox 0.2%.
- Animal Drugs @ FDAThe search page of the Green Book, the FDA list of approved animal drugs.
The site checked these addresses on . The links open in a new tab.
Cite this page
Pet Drug Reports. Diclazuril: adverse event reports that FDA received. https://petdrugreports.com/drug/diclazuril/ Source: FDA Center for Veterinary Medicine, openFDA Animal and Veterinary adverse event reports, export of . Reports received through .
Where the data come from
The counts come from the openFDA Animal and Veterinary adverse event files, export of 30 Oct 2026. The files have the reports that the FDA Center for Veterinary Medicine received through 26 Jun 2026. The files mask brand and manufacturer names. The site counts a drug by the active ingredients that each record gives, and gives no count to a brand, an application or a company. Ingredient names and the lists of approved products follow the FDA Green Book of 2 Nov 2026. The site does not use the application number that a record has.
The site does not publish report text, lot numbers or details of a reporter. FDA's record is the authority. See how the site counts reports, the data sources and the corrections page.
Questions about these reports
- Which brand are these reports about?
The openFDA records give the value "MSK" for the brand name and for the manufacturer name of each drug. FDA says that MSK means "masked". So the site cannot count a report for a brand. The Green Book section of this page lists the brand names with this active ingredient.
- Do the reports show that the drug caused the signs?
No. FDA states this about the data.
When looking at the results, be aware that there is no certainty that the reported drug or device caused the adverse event.
The adverse event may have been related to an underlying disease, other drugs used at the same time or other non-drug related sources.
FDA Center for Veterinary Medicine. Source: Adverse Event Reports for Animal Drugs and Devices
- How many reports did FDA receive in the latest 12 months?
FDA received 18 reports in the 12 months to June 2026. It received 22 reports in the 12 months before. FDA says that a report can take 3 to 6 months to reach the public data. The newest months can get more reports in a later update.
- What kinds of report are in the count?
Of the 181 reports received from August 2000 to June 2026, 24.3% are about a safety issue only. 23.2% are about a lack of expected effectiveness, alone or with a safety issue. 52.5% are about a defect of the product or its package.