Miconazole Nitrate (Conofite, Priconazole Lotion 1% and Spray 1%): adverse event reports that FDA received

Name: Miconazole Nitrate: adverse event reports that FDA received, by year and species
Creator: Pet Drug Reports
License: https://creativecommons.org/publicdomain/zero/1.0/

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 2 Oct 2026. The data have the reports that FDA received through 26 Jun 2026.

This page is not veterinary advice. For an animal that is ill, speak to a veterinarian.

Contacting a veterinarian How to report to FDA

From February 1990 to May 2026, FDA received 276 adverse event reports that name a drug with miconazole nitrate as its active ingredient. Of the 276 reports, 175 (63.4%) are about dogs. 52 reports are about cats (18.8%).

In January to March 2026, FDA received 12 reports that name this drug. The signs that appear in the largest number of the 276 reports are "Lethargy", "Pruritus" and "Accidental exposure". A report is not proof that a drug caused a sign.

Reports that name this drug rose by 40.6% 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 63.4% 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 11 Oct 2026, changed no count of this page.

January to March 2026 is the latest closed quarter in the data. In that quarter FDA received 12 reports that name miconazole nitrate: 12 dog, 0 cat, 0 horse, 0 other or not given.

All updates Feed of updates (RSS)

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 276 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.

Lethargy[unusually tired or inactive]8%22 reports
Pruritus[itching]8%22 reports
Accidental exposure[exposure that was not intended]7.6%21 reports
Lack of efficacy - NOS[the product did not have the expected effect]7.2%20 reports
Vomiting6.9%19 reports
Diarrhoea[diarrhea]6.2%17 reports
Other abnormal test result NOS[abnormal laboratory result, type not specified]5.1%14 reports
Application site erythema[reddened skin where the product was applied]4.7%13 reports
Deafness4.7%13 reports
Death by euthanasia[the animal was euthanized]4.3%12 reports
Dermatitis[inflamed skin]4%11 reports
Skin lesion NOS[NOS: not otherwise specified]4%11 reports
Behavioural disorder NOS[behaviour change, type not specified]3.6%10 reports
Elevated alanine aminotransferase (ALT)[a liver enzyme above the normal range]3.6%10 reports

Show the next 16 signs

Eye irritation3.6%10 reports
Hypersalivation[drooling]3.6%10 reports
Bacterial skin infection NOS[NOS: not otherwise specified]3.3%9 reports
Erythema (for urticaria see Immune SOC)3.3%9 reports
Abnormal cytology2.9%8 reports
Alopecia[hair loss]2.9%8 reports
Elevated creatinine[a kidney value above the normal range]2.9%8 reports
Hyperpigmentation2.9%8 reports
Neutropenia[low neutrophil count]2.9%8 reports
Otitis externa[outer ear inflammation]2.9%8 reports
Anorexia[not eating]2.5%7 reports
Product Defect, General[a product quality report, not a sign in an animal]2.5%7 reports
Skin scab2.5%7 reports
Crust2.2%6 reports
Death2.2%6 reports
Decreased appetite2.2%6 reports

The list shows 30 of 427 coded signs. A report is not proof that a drug caused a sign. Download all signs (CSV)

Reports by species

Dog63.4%175
Cat18.8%52
Human exposure1.4%4

The share is of all 276 reports that name miconazole nitrate. The other reports give a different species or no species.

Reports for each month, Jul 2021 to Jun 2026

Dog84 reports. Largest count in one month: 8 (May 2025)

Cat12 reports

No chart: no month has 5 or more reports.

Horse0 reports

No chart: no month has 5 or more reports.

Other or not given18 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

Reports that name miconazole nitrate, by the year in which FDA received them and by species
Year	Dog	Cat	Other or not given	All species
2026	16	0	0	16
2025	39	6	2	47
2024	12	1	9	22
2023	5	3	3	11
2022	10	1	2	13
2021	4	2	2	8
2020	5	2	3	10
2019	5	2	4	11
2018	10	4	2	16
2017	5	3	3	11
2016	9	1	1	11
2015	8	0	0	8
2014	3	1	0	4
2013	4	0	3	7
2012	2	0	0	2
2011	3	0	1	4
2010	1	0	1	2
2009	0	1	1	2
2008	1	1	2	4
2007	3	1	2	6
2006	6	3	2	11
2005	6	2	0	8
2004	6	2	1	9
2003	2	4	1	7
2002	1	2	1	4
2001	1	2	0	3
2000	3	2	2	7
1999	1	1	0	2
1998	2	3	0	5
1997	1	1	0	2
1996	1	0	0	1
1993	0	0	1	1
1990	0	1	0	1

2026 has the reports that FDA received through May 2026. Download the years (CSV)

What the reports record

Outcome at the time of the report

Recovered/Normal17%47
Recovered with Sequela[recovered, with a lasting effect]1.4%4
Ongoing18.1%50
Died3.6%10
Euthanized3.3%9
Outcome Unknown18.1%50

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 276 reports that name miconazole nitrate.

A report about more than one animal can have more than one outcome.

Kind of report

Safety issue72.5%200
Lack of expected effectiveness6.2%17
Both safety and lack of expected effectiveness4.3%12
Manufacturing or product defect16.7%46
Other0.4%1

165 reports say if the event was serious. 40% 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 year12%33
1 to 3 years16.7%46
4 to 7 years15.2%42
8 to 11 years19.6%54
12 years and over12.3%34
Age not given24.3%67

Weight of the animal

Under 5 kg (11 lb)18.5%51
5 to 9.9 kg (11 to 22 lb)10.9%30
10 to 24.9 kg (22 to 55 lb)13.4%37
25 to 44.9 kg (55 to 99 lb)18.8%52
45 kg and over (99 lb and over)4%11
Weight not given34.4%95

Breed, where the report gives one breed

A breed with many animals has many reports.

Route in the report

Topical41.3%114
Auricular (Otic)13.8%38
Ophthalmic4.3%12
Oral4%11
Cutaneous0.4%1
Intramuscular0.4%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

Conofite
Priconazole Lotion 1% and Spray 1%

What the Green Book records give

Applications with an approval in force: 3
Approved species: Cats, Dogs
Dose forms: Cream, Lotion, Solution
Routes: Topical
Sale: RX (prescription)
Earliest approval date in the records: 14 Nov 2005

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.

Applications in the Green Book of 2 Nov 2026, pioneer applications (NADA) first
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
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

Other pages with this ingredient

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

All drugs by active ingredient. Brand names A to Z

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 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 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 2 Oct 2026. The links open in a new tab.

Cite this page

Pet Drug Reports. Miconazole Nitrate: adverse event reports that FDA received. https://petdrugreports.com/drug/miconazole-nitrate/ Source: FDA Center for Veterinary Medicine, openFDA Animal and Veterinary adverse event reports, export of 30 Oct 2026. Reports received through 26 Jun 2026.

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 45 reports in the 12 months to June 2026. It received 32 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 276 reports received from February 1990 to May 2026, 72.5% are about a safety issue only. 10.5% are about a lack of expected effectiveness, alone or with a safety issue. 16.7% are about a defect of the product or its package.