Orbifloxacin: adverse event reports in all combinations

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

Active ingredient, alone and in combinations

Brand names with this ingredient: Orbax, Posatex.

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

FDA reports received through 26 Jun 2026. Counts include this ingredient alone and in combinations. Why brand names have no separate count.

From July 1997 to June 2026, FDA received 1,996 adverse event reports that name a drug with orbifloxacin, alone or in a combination. 3 sets of active ingredients with orbifloxacin have a drug page.

Of the 1,996 reports, 754 (37.8%) are about dogs. 702 reports are about cats (35.2%). In January to March 2026, FDA received 24 reports that name orbifloxacin, alone or in a combination. The signs that appear in the largest number of the 1,996 reports are "Vomiting", "Anorexia" and "Lethargy". A report is not proof that a drug caused a sign.

Reports that name this ingredient fell by 1.0% 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 37.8% of the reports that name this ingredient, and 72.6% of all reports.

Reports in the latest closed quarter

Reports that name orbifloxacin, by the quarter in which FDA received them
Species	Jan to Mar 2026	Oct to Dec 2025	Jan to Mar 2025
All species	24	27	20
Dog	12	11	4
Cat	9	8	8
Horse	0	0	0
Other or not given	3	8	8

January to March 2026 is the latest closed quarter in the data.

All updates Feed of updates (RSS)

Drug pages with orbifloxacin

A report names a drug by its set of active ingredients. Each set with orbifloxacin that has a drug page is in the table, in order of name. The table has 3 sets.

Drug pages with orbifloxacin, in order of name, with the reports of each page
Active ingredients	Reports, all years	Reports, latest 12 months
Mometasone Furoate Monohydrate + Orbifloxacin + Posaconazole	126	29
Orbifloxacin	1,514	52
Orbifloxacin + Posaconazole	344	8

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 1,996 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.

Vomiting9%179 reports
Anorexia[not eating]7.5%149 reports
Lethargy[unusually tired or inactive]6.7%134 reports
Containers, Damaged[a product quality report, not a sign in an animal]6.5%130 reports
Death by euthanasia[the animal was euthanized]6.5%130 reports
Blindness6.4%128 reports
Death5.6%111 reports
Deafness5.2%104 reports
Containers, Leaking[a product quality report, not a sign in an animal]5.2%103 reports
Lack of efficacy - NOS[the product did not have the expected effect]5.2%103 reports
Ataxia[unsteady, uncoordinated movement]4.7%93 reports
Depression[dull, quiet or withdrawn]4.5%90 reports
Diarrhoea[diarrhea]3.8%76 reports
Lack of efficacy (bacteria) - NOS[the product did not have the expected effect: target not specified]3.6%72 reports

Show the next 16 signs

Partial deafness3.6%71 reports
Convulsion[seizure]3.3%66 reports
Weight loss3.1%62 reports
Mydriasis[dilated pupils]2.9%58 reports
Other abnormal test result NOS[abnormal laboratory result, type not specified]2.9%58 reports
Behavioural disorder NOS[behaviour change, type not specified]2.7%54 reports
Not eating2.4%48 reports
Seizure NOS[seizure, type not specified]2.2%44 reports
Anaemia NOS[low red blood cell count]2.1%42 reports
Hypersalivation[drooling]2.1%41 reports
Vials, Leaking[a product quality report, not a sign in an animal]2.1%41 reports
Dilated pupils1.9%38 reports
Appearance, Abnormal[a product quality report, not a sign in an animal]1.9%37 reports
Decreased appetite1.9%37 reports
Emesis (multiple)[vomiting more than once]1.8%36 reports
Underfilling, Container[a product quality report, not a sign in an animal]1.8%36 reports

Download all signs (CSV)

Reports by species

Dog37.8%754
Cat35.2%702
Human exposure0.7%13
Other0.3%5
Guinea Pig0.2%4
Rabbit0.2%4

Reports for each month, Jul 2021 to Jun 2026

Dog132 reports. Largest count in one month: 9 (Jun 2025)

Cat139 reports. Largest count in one month: 8 (Jul 2023)

Horse0 reports

No chart: no month has 5 or more reports.

Other or not given119 reports. Largest count in one month: 7 (Apr 2023)

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 orbifloxacin, by the year in which FDA received them and by species
Year	Dog	Cat	Other or not given	All species
2026	19	15	4	38
2025	47	31	33	111
2024	27	24	29	80
2023	18	30	25	73
2022	13	29	19	61
2021	16	19	22	57
2020	11	31	36	78
2019	9	30	39	78
2018	17	37	31	85
2017	23	38	46	107
2016	19	46	53	118
2015	13	31	28	72
2014	60	34	30	124
2013	103	61	48	212
2012	99	52	38	189
2011	79	44	32	155
2010	8	25	6	39
2009	5	5	0	10
2008	12	11	1	24
2007	2	7	0	9
2006	8	10	1	19
2005	9	9	1	19
2004	7	6	3	16
2003	15	5	0	20
2002	9	15	3	27
2001	17	20	3	40
2000	30	14	3	47
1999	27	6	6	39
1998	21	13	0	34
1997	11	4	0	15

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/Normal8.3%166
Recovered with Sequela[recovered, with a lasting effect]2.9%58
Ongoing11.1%222
Died8.7%174
Euthanized3.7%74
Outcome Unknown8.1%161

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 1,996 reports that name orbifloxacin.

Kind of report

Safety issue68.3%1,364
Lack of expected effectiveness2.1%42
Both safety and lack of expected effectiveness3.1%62
Manufacturing or product defect26.5%528
Other0%0

Age of the animal

Under 1 year4.6%91
1 to 3 years11.1%221
4 to 7 years14.1%281
8 to 11 years18.5%369
12 years and over22.3%446
Age not given29.5%588

Each share of kind and age is of the 1,996 reports that name orbifloxacin.

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

Orbax
Posatex

What the Green Book records give

Applications with an approval in force: 3
Approved species: Dogs, Cats
Dose forms: Liquid (Suspension), Tablet, Topical Suspension
Routes: Oral, Otic
Sale: RX (prescription)
Earliest approval date in the records: 22 Apr 1997

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
Orbax Tablets	Orbifloxacin	Intervet, Inc.	Dogs, Cats	NADA 141-081
Posatex Otic Suspension	Mometasone Furoate Monohydrate, Orbifloxacin, posaconazole	Intervet, Inc.	Dogs	NADA 141-266
Orbax	Orbifloxacin	Intervet, Inc.	Dogs, Cats	NADA 141-305

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 141-081The FDA record of the application for Orbax Tablets.
Green Book record of NADA 141-266The FDA record of the application for Posatex Otic Suspension.
Green Book record of NADA 141-305The FDA record of the application for Orbax.
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. Orbifloxacin, all combinations: adverse event reports that FDA received. https://petdrugreports.com/ingredient/orbifloxacin/ Source: FDA Center for Veterinary Medicine, openFDA Animal and Veterinary adverse event reports, export of 30 Oct 2026. Reports received through 26 Jun 2026.

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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 96 reports in the 12 months to June 2026. It received 97 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 1,996 reports received from July 1997 to June 2026, 68.3% are about a safety issue only. 5.2% are about a lack of expected effectiveness, alone or with a safety issue. 26.5% are about a defect of the product or its package.