Ormetoprim + Sulfadimethoxine (Primor, Rofenaid 40): adverse event reports that FDA received
Combination of 2 active ingredients
Also sold as: Primor, Rofenaid 40, Romet-30.
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 January 1990 to April 2026, FDA received 1,147 adverse event reports that name a drug with ormetoprim and sulfadimethoxine as its active ingredients. Of the 1,147 reports, 1,050 (91.5%) are about dogs. 42 reports are about cats (3.7%).
In January to March 2026, FDA received no reports that name this drug. The signs that appear in the largest number of the 1,147 reports are "Depression", "Anorexia" and "Vomiting". A report is not proof that a drug caused a sign.
Fewer than 20 reports named this drug in the 12 months before June 2026, so this page gives no change. Reports about dogs are 91.5% of the reports that name this drug, and 72.6% 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 0 reports that name ormetoprim + sulfadimethoxine: 0 dog, 0 cat, 0 horse, 0 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 1,147 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.
- Depression[dull, quiet or withdrawn]13.9%159 reports
- Anorexia[not eating]11.8%135 reports
- Vomiting10.9%125 reports
- Fever10.6%122 reports
- Ataxia[unsteady, uncoordinated movement]10.2%117 reports
- Thrombocytopenia[low platelet count]8.3%95 reports
- Convulsion[seizure]7.9%91 reports
- Elevated alanine aminotransferase (ALT)[a liver enzyme above the normal range]7.3%84 reports
- Elevated serum alkaline phosphatase (SAP)[a liver and bone enzyme above the normal range]7.3%84 reports
- Death6.5%74 reports
- Anaemia NOS[low red blood cell count]5.8%66 reports
- Trembling5.3%61 reports
- Behavioural disorder NOS[behaviour change, type not specified]5.1%58 reports
- Elevated total bilirubin[bilirubin above the normal range]4.6%53 reports
Show the next 16 signs
- Keratoconjunctivitis sicca4.4%51 reports
- Aggression4.4%50 reports
- Death by euthanasia[the animal was euthanized]4.1%47 reports
- Hyperactivity3.8%44 reports
- Restlessness3.7%43 reports
- Diarrhoea[diarrhea]3.4%39 reports
- Lack of efficacy (bacteria) - NOS[the product did not have the expected effect: target not specified]3.4%39 reports
- Leucocytosis NOS[high white blood cell count]3.4%39 reports
- Icterus[jaundice (yellowing)]3.3%38 reports
- Apprehension3.2%37 reports
- Weight loss3.2%37 reports
- Lethargy[unusually tired or inactive]3.1%36 reports
- Weakness3.1%36 reports
- Confusion2.9%33 reports
- Elevated blood urea nitrogen (BUN)[a kidney value above the normal range]2.7%31 reports
- No sign[no clinical sign was reported]2.7%31 reports
The list shows 30 of 551 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 1,147 reports that name ormetoprim + sulfadimethoxine. 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.
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 | 2 | 0 | 0 | 0 | 2 |
| 2024 | 1 | 0 | 0 | 0 | 1 |
| 2023 | 2 | 0 | 0 | 0 | 2 |
| 2022 | 4 | 0 | 0 | 2 | 6 |
| 2021 | 5 | 0 | 0 | 0 | 5 |
| 2020 | 7 | 0 | 0 | 2 | 9 |
| 2019 | 10 | 0 | 0 | 1 | 11 |
| 2018 | 11 | 1 | 0 | 0 | 12 |
| 2017 | 9 | 2 | 0 | 1 | 12 |
| 2016 | 18 | 0 | 0 | 0 | 18 |
| 2015 | 16 | 0 | 0 | 2 | 18 |
| 2014 | 19 | 0 | 0 | 1 | 20 |
| 2013 | 24 | 1 | 0 | 0 | 25 |
| 2012 | 28 | 0 | 0 | 0 | 28 |
| 2011 | 25 | 0 | 0 | 2 | 27 |
| 2010 | 17 | 2 | 1 | 0 | 20 |
| 2009 | 22 | 3 | 0 | 1 | 26 |
| 2008 | 21 | 1 | 0 | 0 | 22 |
| 2007 | 31 | 1 | 0 | 2 | 34 |
| 2006 | 46 | 4 | 0 | 4 | 54 |
| 2005 | 34 | 5 | 0 | 1 | 40 |
| 2004 | 44 | 2 | 0 | 1 | 47 |
| 2003 | 19 | 0 | 0 | 3 | 22 |
| 2002 | 24 | 0 | 0 | 2 | 26 |
| 2001 | 43 | 3 | 0 | 1 | 47 |
| 2000 | 50 | 4 | 0 | 2 | 56 |
| 1999 | 70 | 4 | 0 | 4 | 78 |
| 1998 | 82 | 1 | 0 | 9 | 92 |
| 1997 | 48 | 1 | 0 | 4 | 53 |
| 1996 | 72 | 1 | 0 | 0 | 73 |
| 1995 | 73 | 3 | 0 | 3 | 79 |
| 1994 | 120 | 3 | 0 | 4 | 127 |
| 1993 | 7 | 0 | 0 | 0 | 7 |
| 1992 | 20 | 0 | 0 | 0 | 20 |
| 1991 | 16 | 0 | 0 | 2 | 18 |
| 1990 | 10 | 0 | 0 | 0 | 10 |
2026 has the reports that FDA received through Apr 2026. Download the years (CSV)
What the reports record
Outcome at the time of the report
- Recovered/Normal3.8%44
- Recovered with Sequela[recovered, with a lasting effect]0%0
- Ongoing7.2%83
- Died9.9%113
- Euthanized0.6%7
- Outcome Unknown3%34
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 1,147 reports that name ormetoprim + sulfadimethoxine.
A report about more than one animal can have more than one outcome.
Kind of report
- Safety issue94.9%1,088
- Lack of expected effectiveness0.6%7
- Both safety and lack of expected effectiveness1.3%15
- Manufacturing or product defect3.2%37
- Other0%0
156 reports say if the event was serious. 30.1% 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 year15.5%178
- 1 to 3 years21.4%246
- 4 to 7 years24.7%283
- 8 to 11 years18.7%214
- 12 years and over8.1%93
- Age not given11.6%133
Weight of the animal
- Under 5 kg (11 lb)11.9%137
- 5 to 9.9 kg (11 to 22 lb)13.3%153
- 10 to 24.9 kg (22 to 55 lb)22.6%259
- 25 to 44.9 kg (55 to 99 lb)30.7%352
- 45 kg and over (99 lb and over)8.3%95
- Weight not given13.2%151
Breed, where the report gives one breed
- Labrador Retriever13.7%157
- Golden Retriever6.9%79
- German Shepherd Dog3.5%40
- Domestic2.5%29
- Doberman Pinscher2.5%29
- Poodle2.5%29
- Bulldog2.1%24
- Shih Tzu2.1%24
A breed with many animals has many reports.
Route in the report
- Oral95.6%1,096
- Subcutaneous0.1%1
Each bar is on a scale of 0 to 100%.
Approved animal drugs with these active ingredients (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
- Primor
- Rofenaid 40
- Romet-30
What the Green Book records give
- Applications with an approval in force
- 3
- Approved species
- Chickens, Chukar Partridges, Dogs, Ducks, Fish, Turkeys
- Dose forms
- Type A Medicated Article, Tablet
- Routes
- Oral
- Sale
- VFD (veterinary feed directive), 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 |
|---|---|---|---|---|
| Rofenaid 40 | Ormetoprim, Sulfadimethoxine | Phibro Animal Health Corp. | Chickens, Turkeys | NADA 040-209 |
| Primor Tablets | Ormetoprim, Sulfadimethoxine | Zoetis Inc. | Dogs | NADA 100-929 |
| Romet-30 | Ormetoprim, Sulfadimethoxine | Pharmaq AS | Not in the list of major species | NADA 125-933 |
Other pages with one of these ingredients
A report names a drug by its set of active ingredients. Each set has its own page. The list is in order of name.
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 100-929The FDA record of the application for Primor Tablets.
- Green Book record of NADA 040-209The FDA record of the application for Rofenaid 40.
- Green Book record of NADA 125-933The FDA record of the application for Romet-30.
- 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. Ormetoprim + Sulfadimethoxine: adverse event reports that FDA received. https://petdrugreports.com/drug/ormetoprim-sulfadimethoxine/ 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 these active ingredients.
- 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 2 reports in the 12 months to June 2026. It received 1 report 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 1,147 reports received from January 1990 to April 2026, 94.9% are about a safety issue only. 1.9% are about a lack of expected effectiveness, alone or with a safety issue. 3.2% are about a defect of the product or its package.