Dexamethasone (Azium, Dexium): adverse event reports that FDA received
Active ingredient
Also sold as: Azium, Dexium, Dexameth-A-Vet, Pet Derm III, Zonometh, Dexachel.
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 November 1988 to June 2026, FDA received 3,041 adverse event reports that name a drug with dexamethasone as its active ingredient. Of the 3,041 reports, 2,278 (74.9%) are about dogs. 622 reports are about cats (20.5%).
In January to March 2026, FDA received 73 reports that name this drug. The signs that appear in the largest number of the 3,041 reports are "Vomiting", "Lethargy" and "Diarrhoea". A report is not proof that a drug caused a sign.
Reports that name this drug rose by 7.5% 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 cats are 20.5% of the reports that name this drug, and 11% of all reports.
Since the last update of the FDA data
The site recorded an update of the FDA data on . FDA changed these counts for January to March 2026:
- All species: from 64 to 73.
- Dog: from 46 to 55.
January to March 2026 is the latest closed quarter in the data. In that quarter FDA received 73 reports that name dexamethasone: 55 dog, 17 cat, 1 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 3,041 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.
- Vomiting27.7%842 reports
- Lethargy[unusually tired or inactive]27.5%836 reports
- Diarrhoea[diarrhea]12.2%372 reports
- Death12.2%371 reports
- Anorexia[not eating]10.8%329 reports
- Death by euthanasia[the animal was euthanized]10.4%317 reports
- Anaphylaxis[sudden severe allergic-type reaction]9.9%302 reports
- Other abnormal test result NOS[abnormal laboratory result, type not specified]9%273 reports
- Fever8.4%255 reports
- Elevated alanine aminotransferase (ALT)[a liver enzyme above the normal range]8.3%251 reports
- Pale mucous membrane[pale gums]7.6%232 reports
- Facial swelling7.5%227 reports
- Not eating7.1%216 reports
- Anaemia NOS[low red blood cell count]6.8%206 reports
Show the next 16 signs
- Lack of efficacy - NOS[the product did not have the expected effect]6.7%205 reports
- Leucocytosis NOS[high white blood cell count]6.6%200 reports
- Weight loss6.5%197 reports
- Panting6.4%194 reports
- Ataxia[unsteady, uncoordinated movement]6.2%190 reports
- Seizure NOS[seizure, type not specified]5.7%174 reports
- Hives5.6%169 reports
- Decreased appetite5.4%164 reports
- Abnormal radiograph finding5.3%161 reports
- Neutrophilia[high neutrophil count]5.2%158 reports
- Emesis[vomiting]4.8%147 reports
- Dehydration4.8%145 reports
- Elevated blood urea nitrogen (BUN)[a kidney value above the normal range]4.7%143 reports
- Thrombocytopenia[low platelet count]4.7%143 reports
- Weakness4.5%137 reports
- Behavioural disorder NOS[behaviour change, type not specified]4.2%128 reports
The list shows 30 of 1,595 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 3,041 reports that name dexamethasone. 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.
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 | 137 | 32 | 2 | 2 | 173 |
| 2025 | 221 | 66 | 2 | 13 | 302 |
| 2024 | 186 | 58 | 8 | 2 | 254 |
| 2023 | 127 | 38 | 6 | 4 | 175 |
| 2022 | 117 | 33 | 5 | 3 | 158 |
| 2021 | 151 | 27 | 1 | 6 | 185 |
| 2020 | 192 | 46 | 2 | 5 | 245 |
| 2019 | 186 | 42 | 1 | 7 | 236 |
| 2018 | 190 | 35 | 0 | 9 | 234 |
| 2017 | 154 | 36 | 3 | 3 | 196 |
| 2016 | 156 | 51 | 2 | 3 | 212 |
| 2015 | 73 | 29 | 4 | 3 | 109 |
| 2014 | 72 | 23 | 4 | 2 | 101 |
| 2013 | 136 | 60 | 1 | 4 | 201 |
| 2012 | 136 | 37 | 4 | 3 | 180 |
| 2011 | 14 | 2 | 2 | 1 | 19 |
| 2010 | 1 | 0 | 0 | 1 | 2 |
| 2009 | 3 | 1 | 0 | 2 | 6 |
| 2008 | 4 | 1 | 0 | 1 | 6 |
| 2007 | 1 | 1 | 0 | 0 | 2 |
| 2006 | 3 | 0 | 1 | 3 | 7 |
| 2005 | 1 | 0 | 0 | 1 | 2 |
| 2004 | 0 | 1 | 1 | 2 | 4 |
| 2003 | 2 | 0 | 1 | 0 | 3 |
| 2002 | 2 | 1 | 1 | 0 | 4 |
| 2001 | 0 | 1 | 1 | 2 | 4 |
| 2000 | 0 | 0 | 1 | 0 | 1 |
| 1999 | 5 | 0 | 1 | 1 | 7 |
| 1998 | 4 | 0 | 1 | 0 | 5 |
| 1997 | 0 | 0 | 0 | 1 | 1 |
| 1996 | 1 | 0 | 1 | 0 | 2 |
| 1995 | 1 | 0 | 0 | 0 | 1 |
| 1992 | 2 | 0 | 0 | 0 | 2 |
| 1989 | 0 | 1 | 0 | 0 | 1 |
| 1988 | 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/Normal21.8%664
- Recovered with Sequela[recovered, with a lasting effect]0.9%27
- Ongoing37%1,126
- Died13.2%402
- Euthanized10.3%312
- Outcome Unknown16.2%492
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 3,041 reports that name dexamethasone.
A report about more than one animal can have more than one outcome.
Kind of report
- Safety issue88.5%2,691
- Lack of expected effectiveness4.3%132
- Both safety and lack of expected effectiveness5.9%178
- Manufacturing or product defect1.2%36
- Other0.1%4
2,958 reports say if the event was serious. 65.9% 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 year9%274
- 1 to 3 years28.2%857
- 4 to 7 years24.9%757
- 8 to 11 years19.4%589
- 12 years and over14.9%453
- Age not given3.7%111
Weight of the animal
- Under 5 kg (11 lb)21.2%644
- 5 to 9.9 kg (11 to 22 lb)25.1%763
- 10 to 24.9 kg (22 to 55 lb)22.4%680
- 25 to 44.9 kg (55 to 99 lb)20.9%636
- 45 kg and over (99 lb and over)4.7%143
- Weight not given5.8%175
Breed, where the report gives one breed
- Domestic Shorthair13.2%401
- Labrador Retriever5.1%156
- Chihuahua3.2%98
- American Pit Bull Terrier2.5%76
- Shih Tzu2.4%72
- French Bulldog2.1%63
- Domestic Longhair2%61
- Yorkshire Terrier1.9%59
A breed with many animals has many reports.
Route in the report
- Intravenous6.3%191
- Subcutaneous5.5%168
- Ophthalmic4.5%138
- Intramuscular3.7%111
- Parenteral3.6%110
- Oral3.3%100
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
- Azium
- Dexium
- Dexameth-A-Vet
- Pet Derm III
- Zonometh
- Dexachel
What the Green Book records give
- Applications with an approval in force
- 16
- Approved species
- Dogs, Equids, Cats, Cattle
- Dose forms
- Liquid (Solution), Tablet, Bolus, Liquid, Powder, Tablet (Chewable)
- Routes
- Intravenous, Intramuscular, Oral
- 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 |
|---|---|---|---|---|
| Azium Tablets 0.25 mg | Dexamethasone | Intervet, Inc. | Dogs, Cats | NADA 011-885 |
| Azium Aqueous Suspension Veterinary | Dexamethasone | Intervet, Inc. | Dogs, Cats, Horses, Cattle | NADA 011-901 |
| Azium Solution | Dexamethasone | Intervet, Inc. | Dogs, Cats, Horses, Cattle | NADA 012-559 |
| Azium Powder | Dexamethasone | Intervet, Inc. | Horses, Cattle | NADA 030-434 |
| Azium Boluses 10 mg | Dexamethasone | Intervet, Inc. | Horses, Cattle | NADA 030-435 |
| Azium Oral Solution 2 mg | Dexamethasone | Intervet, Inc. | Dogs, Cats, Horses, Cattle | NADA 092-835 |
| Dexium Tablets | Dexamethasone | Bimeda Animal Health Ltd. | Dogs, Cats | NADA 095-218 |
| Dexameth-A-Vet Injection | Dexamethasone | Bimeda Animal Health Ltd. | Dogs | NADA 099-606 |
| Dexameth-A-Vet | Dexamethasone | Bimeda Animal Health Ltd. | Horses | NADA 099-607 |
| Pet Derm III Tablets | Dexamethasone | Kinetic Technologies, LLC | Dogs | NADA 108-687 |
| Dexamethasone Sterile Solution | Dexamethasone | Kinetic Technologies, LLC | Dogs, Cats, Horses | NADA 111-369 |
| Zonometh Solution | Dexamethasone | Huvepharma EOOD | Dogs, Cats, Horses | NADA 128-089 |
| Dexachel | Dexamethasone | Zoetis Inc. | Dogs, Cats, Horses | NADA 130-660 |
| Dexamethasone Solution | Dexamethasone | Huvepharma EOOD | Dogs, Cats, Horses, Cattle | ANADA 200-108 |
| Dexium | Dexamethasone | Bimeda Animal Health Ltd. | Dogs, Cats, Horses, Cattle | ANADA 200-312 |
| Dexamethasone Injection | Dexamethasone | Sparhawk Laboratories, Inc. | Horses, Cattle | ANADA 200-324 |
| Dexamethasone Injectionapproval withdrawn | Dexamethasone | Watson Laboratories, Inc. | Not in the list of major species | NADA 110-350 |
| Dexamethasone Solutionapproval withdrawn | Dexamethasone | Med-Pharmex, Inc. | Horses, Cattle | ANADA 200-456 |
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
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 011-885The FDA record of the application for Azium Tablets 0.25 mg.
- Green Book record of NADA 011-901The FDA record of the application for Azium Aqueous Suspension Veterinary.
- Green Book record of NADA 012-559The FDA record of the application for Azium Solution.
- Green Book record of NADA 092-835The FDA record of the application for Azium Oral Solution 2 mg.
- Green Book record of NADA 095-218The FDA record of the application for Dexium Tablets.
- Green Book record of NADA 099-606The FDA record of the application for Dexameth-A-Vet Injection.
- 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. Dexamethasone: adverse event reports that FDA received. https://petdrugreports.com/drug/dexamethasone/ 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 314 reports in the 12 months to June 2026. It received 292 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 3,041 reports received from November 1988 to June 2026, 88.5% are about a safety issue only. 10.2% are about a lack of expected effectiveness, alone or with a safety issue. 1.2% are about a defect of the product or its package.