Restlessness: in adverse event reports for animal drugs

Clinical sign, a VeDDRA term

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 June 1987 to June 2026, FDA received 9,372 adverse event reports for animal drugs that list this sign. That is 0.7% of the 1,378,761 reports that FDA received from January 1987 to June 2026. In the 12 months to June 2026, FDA received 449 reports that list this sign.

Of the 9,372 reports, 86.4% are about dogs. A report can list more than one sign and more than one drug. A report is not proof that a drug caused a sign.

By number of reports in all years, this sign is number 68 of 1,149 clinical signs with a page. Reports that list this sign rose by 3.2% 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 86.4% of the reports that list this sign, and 72.6% of all reports.

Drug pages with reports that list this sign

The table has every drug page with 20 or more reports that list this sign, in order of name. No count decides which drug is in the table. The table has 95 drug pages.

Show the 95 drug pages

Drug pages with 20 or more reports that list this sign, in order of name
Active ingredients	Reports that list the sign
(S) - methoprene	309
Acepromazine Maleate	43
Afoxolaner	596
Afoxolaner + Moxidectin + Pyrantel Pamoate	55
Amoxicillin	46
Amoxicillin + Clavulanate Potassium	23
Amoxicillin Trihydrate + Clavulanate Potassium	37
Atipamezole Hydrochloride	82
Bedinvetmab	288
Buprenorphine	253
Butorphanol Tartrate	103
Capromorelin	20
Carprofen	731
Cefovecin sodium	119
Cefpodoxime proxetil	67
Cephalexin	22
Clomipramine Hydrochloride	40
Cyclosporine	329
Deracoxib	197
Desoxycorticosterone Pivalate	37
Dexamethasone	57
Dexmedetomidine	51
Dexmedetomidine hydrochloride	36
Diazepam	21
Diphenhydramine	98
Dirlotapide	24
Doxycycline	46
Emodepside + Praziquantel	48
Enalapril Maleate	30
Enrofloxacin	80
Famotidine	74
Febantel + Praziquantel + Pyrantel Pamoate	121
Fenbendazole	56
Fentanyl	33
Firocoxib	122
Florfenicol + Mometasone furoate + Terbinafine	42
Fluoxetine hydrochloride	57
Fluralaner	347
Frunevetmab	38
Gabapentin	218
Grapiprant	109
Hydromorphone	26
Imidacloprid	55
Imidacloprid + Moxidectin	237
Insulin	70
Isoflurane	75
Ivermectin	144
Ivermectin + Praziquantel	24
Ivermectin + Praziquantel + Pyrantel Pamoate	44
Ivermectin + Pyrantel Pamoate	511
Ketamine Hydrochloride	78
Ketoconazole	31
Levothyroxine sodium	69
Lotilaner	72
Lotilaner + Moxidectin + Praziquantel + Pyrantel Pamoate	20
Lufenuron + Milbemycin Oxime	137
Lufenuron + Milbemycin Oxime + Praziquantel	23
Marbofloxacin	27
Maropitant	197
Melarsomine Dihydrochloride	535
Meloxicam	185
Methocarbamol	22
Metronidazole	51
Midazolam	51
Milbemycin Oxime	123
Milbemycin Oxime + Praziquantel	103
Milbemycin Oxime + Spinosad	647
Mirtazapine	28
Moxidectin	290
Nitenpyram	245
Oclacitinib	228
Ormetoprim + Sulfadimethoxine	43
Phenylpropanolamine hydrochloride	44
Pimobendan	111
Polysulfated Glycosaminoglycan	67
Praziquantel	20
Praziquantel + Pyrantel Pamoate	33
Prednisolone	35
Prednisolone + Trimeprazine Tartrate	25
Prednisone	149
Propofol	54
Pyrantel Pamoate	29
Pyrantel Pamoate + Sarolaner	178
Robenacoxib	57
Sarolaner	126
Sarolaner + Selamectin	27
Selamectin	347
Selegiline Hydrochloride	263
Sevoflurane	22
Spinosad	370
Tigilanol tiglate	29
Tiletamine Hydrochloride + Zolazepam Hydrochloride	20
Tramadol	81
Trazodone	28
Trilostane	172

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. A report can name more than one drug.

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.
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

Ingredients, all combinations

The list has every active ingredient with 20 or more reports that list this sign, in order of name. It has 91 ingredients.

Show the 91 ingredients

Reports by species

Dog86.4%8,093
Cat10.9%1,021
Horse1.5%140
Cattle0.8%72
Pig0.2%23
Goat0.1%5

The share is of the 9,372 reports that list this sign. The sign is in 0.8% of all reports about the species dog. The sign is in 0.7% of all reports about the species cat.

Reports by month and by year

Reports for each month, Jul 2021 to Jun 2026. The month is the month in which FDA received the report.

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 that list Restlessness, by the year in which FDA received them
Year	Reports
2026	244
2025	412
2024	483
2023	353
2022	286
2021	307
2020	316
2019	328
2018	323
2017	396
2016	434
2015	487
2014	506
2013	543
2012	453
2011	382
2010	363
2009	356
2008	326
2007	271
2006	202
2005	242
2004	249
2003	138
2002	139
2001	181
2000	197
1999	148
1998	118
1997	64
1996	30
1995	17
1994	18
1993	7
1992	6
1991	9
1990	5
1989	11
1988	12
1987	10

What these reports record

Outcome at the time of the report

Reports with this sign
All reports

Recovered/Normal23.8%2,235, All reports: 20.7%
Recovered with Sequela[recovered, with a lasting effect]1.5%143, All reports: 2.3%
Ongoing14.8%1,389, All reports: 17.4%
Died6.5%611, All reports: 4.9%
Euthanized2.6%239, All reports: 1.5%
Outcome Unknown17.9%1,673, All reports: 22.7%

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 9,372 reports that list this sign.

Age of the animal

Reports with this sign
All reports

Under 1 year9%845, All reports: 9.5%
1 to 3 years22.3%2,089, All reports: 23.9%
4 to 7 years23.5%2,207, All reports: 20.2%
8 to 11 years20.9%1,961, All reports: 15.4%
12 years and over19.7%1,846, All reports: 10.7%
Age not given4.5%424, All reports: 20.3%

The outcome is for the full report, not for this sign only.

Next in the A to Z list of signs

Respiratory signs
Respiratory sound
Respiratory tract disorder NOS[NOS: not otherwise specified]
Respiratory tract infection NOS[NOS: not otherwise specified]
Retching
Retinal disorder NOS[NOS: not otherwise specified]
Reverse sneezing
Rigidity

All clinical signs

Cite this page

Pet Drug Reports. Restlessness: adverse event reports for animal drugs. https://petdrugreports.com/reaction/restlessness/ 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 counts the different spellings of one VeDDRA term together.

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 this sign

What does this term mean in a report?: It is a term from VeDDRA, the list of terms that FDA and drug companies use to code a report. The person who coded the report selected the term.
How does the count of the latest 12 months compare with the 12 months before?: FDA received 449 reports in the 12 months to June 2026. It received 435 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.
How many of these reports have a serious flag?: Of the 5,778 reports that say if the event was serious, 46.9% have the serious flag. The person who sends a report sets the flag.
Does a drug in the table cause this sign?: The reports do not show that. A report can name more than one drug. 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