Miconazole Nitrate: adverse event reports in all combinations
Active ingredient, alone and in combinations
Brand names with this ingredient: Conofite, Surolan, Easotic, Priconazole Lotion 1% and Spray 1%.
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 FDAFDA reports received through . Counts include this ingredient alone and in combinations. Why brand names have no separate count.
From February 1990 to June 2026, FDA received 2,450 adverse event reports that name a drug with miconazole nitrate, alone or in a combination. 4 sets of active ingredients with miconazole nitrate have a drug page.
Of the 2,450 reports, 1,285 (52.4%) are about dogs. 82 reports are about cats (3.3%). In January to March 2026, FDA received 54 reports that name miconazole nitrate, alone or in a combination. The signs that appear in the largest number of the 2,450 reports are "Dispenser, Abnormal", "Loss of hearing" and "Uncoded sign". A report is not proof that a drug caused a sign.
Reports that name this ingredient rose by 6.8% 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 dogs are 52.4% of the reports that name this ingredient, and 72.6% of all reports.
Reports in the latest closed quarter
| Species | Jan to Mar 2026 | Oct to Dec 2025 | Jan to Mar 2025 |
|---|---|---|---|
| All species | 54 | 83 | 58 |
| Dog | 53 | 50 | 37 |
| Cat | 0 | 2 | 2 |
| Horse | 0 | 0 | 0 |
| Other or not given | 1 | 31 | 19 |
January to March 2026 is the latest closed quarter in the data.
Drug pages with miconazole nitrate
A report names a drug by its set of active ingredients. Each set with miconazole nitrate that has a drug page is in the table, in order of name. The table has 4 sets.
| Active ingredients | Reports, all years | Reports, latest 12 months |
|---|---|---|
| Gentamicin Sulfate + Hydrocortisone aceponate + Miconazole Nitrate | 1,861 | 197 |
| Miconazole Nitrate | 276 | 45 |
| Miconazole Nitrate + Polymyxin B Sulfate + Prednisolone Acetate | 256 | 7 |
| Miconazole Nitrate + Prednisolone Acetate | 26 | 1 |
A report can name more than one set, so the counts of the sets can add to more than the count of the page.
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.
FDA Center for Veterinary Medicine. Source: Adverse Event Reports for Animal Drugs and Devices
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 2,450 reports that list the sign. One report can list more than one sign and more than one drug.
The sign that is in the largest number of the reports comes first.
- Dispenser, Abnormal[a product quality report, not a sign in an animal]25.1%615 reports
- Loss of hearing14.7%359 reports
- Uncoded sign[a sign with no matching dictionary term]12.7%311 reports
- Difficulty of Use[a product quality report, not a sign in an animal]12.4%305 reports
- Product defect, product difficult to use/handle[a product quality report, not a sign in an animal]6.5%160 reports
- Hearing affected6.2%151 reports
- Lack of efficacy - NOS[the product did not have the expected effect]5.3%131 reports
- Administration device NOS, priming issue5.3%130 reports
- Product Defect, General[a product quality report, not a sign in an animal]4.8%118 reports
- Deafness4.8%117 reports
- Lethargy[unusually tired or inactive]4.1%100 reports
- Administration device NOS, abnormal3%73 reports
- Vomiting2.9%71 reports
- Diarrhoea[diarrhea]2.4%59 reports
Show the next 16 signs
- Appearance, Abnormal[a product quality report, not a sign in an animal]2.4%58 reports
- Administration device NOS, malfunction2.2%55 reports
- Behavioural disorder NOS[behaviour change, type not specified]2%50 reports
- Containers, Damaged[a product quality report, not a sign in an animal]2%48 reports
- Accidental exposure[exposure that was not intended]1.5%37 reports
- Pruritus[itching]1.4%35 reports
- Underfilling, Container[a product quality report, not a sign in an animal]1.4%35 reports
- Containers, Leaking[a product quality report, not a sign in an animal]1.4%34 reports
- Application site erythema[reddened skin where the product was applied]1.3%32 reports
- Emesis[vomiting]1.3%32 reports
- Head shake - ear disorder1.2%30 reports
- Other abnormal test result NOS[abnormal laboratory result, type not specified]1.2%30 reports
- Death by euthanasia[the animal was euthanized]1.2%29 reports
- Not eating1.1%28 reports
- Pinnal erythema1.1%26 reports
- Lack of efficacy (bacteria) - NOS[the product did not have the expected effect: target not specified]1%25 reports
Reports by 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.
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 | 78 | 0 | 0 | 1 | 79 |
| 2025 | 164 | 11 | 0 | 122 | 297 |
| 2024 | 115 | 3 | 0 | 83 | 201 |
| 2023 | 74 | 4 | 0 | 87 | 165 |
| 2022 | 57 | 3 | 0 | 101 | 161 |
| 2021 | 66 | 2 | 0 | 101 | 169 |
| 2020 | 80 | 2 | 0 | 81 | 163 |
| 2019 | 8 | 2 | 0 | 5 | 15 |
| 2018 | 15 | 4 | 0 | 2 | 21 |
| 2017 | 9 | 3 | 0 | 4 | 16 |
| 2016 | 18 | 1 | 0 | 8 | 27 |
| 2015 | 166 | 6 | 0 | 131 | 303 |
| 2014 | 185 | 5 | 0 | 117 | 307 |
| 2013 | 116 | 5 | 0 | 161 | 282 |
| 2012 | 77 | 4 | 0 | 64 | 145 |
| 2011 | 22 | 1 | 0 | 1 | 24 |
| 2010 | 1 | 0 | 0 | 1 | 2 |
| 2009 | 0 | 1 | 0 | 1 | 2 |
| 2008 | 1 | 1 | 0 | 2 | 4 |
| 2007 | 3 | 1 | 0 | 2 | 6 |
| 2006 | 6 | 3 | 0 | 2 | 11 |
| 2005 | 6 | 2 | 0 | 0 | 8 |
| 2004 | 6 | 2 | 0 | 1 | 9 |
| 2003 | 2 | 4 | 0 | 1 | 7 |
| 2002 | 1 | 2 | 0 | 1 | 4 |
| 2001 | 1 | 2 | 0 | 0 | 3 |
| 2000 | 3 | 2 | 0 | 2 | 7 |
| 1999 | 1 | 1 | 0 | 0 | 2 |
| 1998 | 2 | 3 | 0 | 0 | 5 |
| 1997 | 1 | 1 | 0 | 0 | 2 |
| 1996 | 1 | 0 | 0 | 0 | 1 |
| 1993 | 0 | 0 | 0 | 1 | 1 |
| 1990 | 0 | 1 | 0 | 0 | 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/Normal17.7%434
- Recovered with Sequela[recovered, with a lasting effect]4.2%102
- Ongoing4.9%119
- Died0.9%21
- Euthanized1.1%27
- Outcome Unknown25.4%622
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 2,450 reports that name miconazole nitrate.
Kind of report
- Safety issue49.3%1,208
- Lack of expected effectiveness4.2%102
- Both safety and lack of expected effectiveness2.5%62
- Manufacturing or product defect44%1,077
- Otherunder 0.1%1
Age of the animal
- Under 1 year2.6%64
- 1 to 3 years7.6%187
- 4 to 7 years10.4%254
- 8 to 11 years17.8%436
- 12 years and over14.7%361
- Age not given46.9%1,148
Each share of kind and age is of the 2,450 reports that name miconazole nitrate.
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
- Conofite
- Surolan
- Easotic
- Priconazole Lotion 1% and Spray 1%
What the Green Book records give
- Applications with an approval in force
- 5
- Approved species
- Dogs, Cats
- Dose forms
- Cream, Liquid (Suspension), Lotion, Otic Suspension, Solution
- Routes
- Topical, Otic
- Sale
- 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 |
|---|---|---|---|---|
| Conofite Cream 2% | Miconazole Nitrate | Intervet, Inc. | Dogs, Cats | NADA 095-183 |
| Conofite Lotion 1% | Miconazole Nitrate | Intervet, Inc. | Dogs, Cats | NADA 095-184 |
| Surolan | Miconazole Nitrate, Polymyxin B Sulfate, Prednisolone Acetate | Elanco US Inc. | Dogs | NADA 141-298 |
| Easotic | Gentamicin Sulfate, Hydrocortisone aceponate, Miconazole Nitrate | Virbac AH, Inc. | Dogs | NADA 141-330 |
| Priconazole Lotion 1% and Spray 1% | Miconazole Nitrate | First Priority, Inc. | Dogs, Cats | ANADA 200-362 |
| Miconosolapproval withdrawn | Miconazole Nitrate | Med-Pharmex, Inc. | Dogs, Cats | ANADA 200-196 |
FDA pages for this ingredient
- 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 095-183The FDA record of the application for Conofite Cream 2%.
- Green Book record of NADA 095-184The FDA record of the application for Conofite Lotion 1%.
- Green Book record of NADA 141-298The FDA record of the application for Surolan.
- Green Book record of NADA 141-330The FDA record of the application for Easotic.
- Green Book record of ANADA 200-362The FDA record of the application for Priconazole Lotion 1% and Spray 1%.
- 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. Miconazole Nitrate, all combinations: adverse event reports that FDA received. https://petdrugreports.com/ingredient/miconazole-nitrate/ 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. Ingredient names follow the Green Book, with salts and forms as FDA lists them.
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 brand names with this active ingredient.
- Do the reports show that the ingredient caused the signs?
No. A report can name more than one drug, and a drug can have more than one active ingredient. 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 253 reports in the 12 months to June 2026. It received 237 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 2,450 reports received from February 1990 to June 2026, 49.3% are about a safety issue only. 6.7% are about a lack of expected effectiveness, alone or with a safety issue. 44% are about a defect of the product or its package.