Pet Drug Reports

Fluoxetine hydrochloride (Reconcile)adverse event reports that FDA received

Active ingredient

The name in brackets is a brand name 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 . 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 FDA

From December 2004 to June 2026, FDA received 3,019 adverse event reports that name a drug with fluoxetine hydrochloride as its active ingredient. Of the 3,019 reports, 2,588 (85.7%) are about dogs. 242 reports are about cats (8%).

In January to March 2026, FDA received 74 reports that name this drug. The signs that appear in the largest number of the 3,019 reports are "Lack of efficacy - NOS", "Vomiting" and "Anorexia". A report is not proof that a drug caused a sign.

Reports that name this drug rose by 3.6% 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 85.7% of the reports that name this drug, and 72.6% 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 62 to 74.
  • Dog: from 54 to 61.

January to March 2026 is the latest closed quarter in the data. In that quarter FDA received 74 reports that name fluoxetine hydrochloride: 61 dog, 8 cat, 0 horse, 5 other or not given.

All updatesFeed 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 3,019 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.

  1. Lack of efficacy - NOS[the product did not have the expected effect]12.8%386 reports
  2. Vomiting12%362 reports
  3. Anorexia[not eating]11%332 reports
  4. Lethargy[unusually tired or inactive]8.4%254 reports
  5. Depression[dull, quiet or withdrawn]7.5%226 reports
  6. Diarrhoea[diarrhea]6.5%195 reports
  7. Behavioural disorder NOS[behaviour change, type not specified]5.1%153 reports
  8. Seizure NOS[seizure, type not specified]4.8%145 reports
  9. Accidental exposure[exposure that was not intended]4.6%140 reports
  10. Decreased appetite4.2%128 reports
  11. Weight loss4.1%125 reports
  12. Aggression3.8%114 reports
  13. Shaking3.5%107 reports
  14. Emesis[vomiting]3.3%101 reports
Show the next 16 signs
  1. Trembling3.3%101 reports
  2. Panting3.2%97 reports
  3. Not eating3.1%94 reports
  4. Anxiety3.1%93 reports
  5. Elevated alanine aminotransferase (ALT)[a liver enzyme above the normal range]2.9%89 reports
  6. Ataxia[unsteady, uncoordinated movement]2.9%88 reports
  7. Vocalisation[crying out or unusual noise]2.7%83 reports
  8. Death by euthanasia[the animal was euthanized]2.7%82 reports
  9. Tablets, Abnormal[a product quality report, not a sign in an animal]2.5%75 reports
  10. Apprehension2.4%73 reports
  11. Ineffective, loss of effect[legacy FDA term: the product did not have the expected effect (loss of effect)]2.4%71 reports
  12. Other abnormal test result NOS[abnormal laboratory result, type not specified]2%61 reports
  13. Convulsion[seizure]2%59 reports
  14. Restlessness1.9%57 reports
  15. Polydipsia[drinking more than usual]1.7%50 reports
  16. Death1.6%48 reports

The list shows 30 of 1,065 coded signs. A report is not proof that a drug caused a sign. Download all signs (CSV)

Reports by species

  • Dog85.7%2,588
  • Cat8%242
  • Human exposure0.8%25
  • Other0.1%2

The share is of all 3,019 reports that name fluoxetine hydrochloride. The other reports give a different species or no species.

Reports for each month, Jul 2021 to Jun 2026

Dog807 reports. Largest count in one month: 30 (Apr 2026)
Cat143 reports. Largest count in one month: 9 (Aug 2025)
Horse0 reports

No chart: no month has 5 or more reports.

Other or not given101 reports. Largest count in one month: 5 (Oct 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 fluoxetine hydrochloride, by the year in which FDA received them and by species
YearDogCatHorseOther or not givenAll species
20261311809158
202524650035331
202421439015268
20239720019136
20227713011101
2021846017107
20207720887
20197040579
20186340471
20176950175
20166670174
20155250461
20145380162
201312413010147
20121761309198
201118111013205
2010183309195
20091937011211
2008217506228
2007214901224
200410001

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/Normal19.3%583
  • Recovered with Sequela[recovered, with a lasting effect]3.6%108
  • Ongoing17.1%516
  • Died2.1%62
  • Euthanized2.3%69
  • Outcome Unknown20.2%609

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 3,019 reports that name fluoxetine hydrochloride.

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

Kind of report

  • Safety issue81.3%2,455
  • Lack of expected effectiveness4.8%144
  • Both safety and lack of expected effectiveness7.3%221
  • Manufacturing or product defect6.5%196
  • Other0.1%3

1,887 reports say if the event was serious. 36.6% 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 year2.5%75
  • 1 to 3 years23.1%698
  • 4 to 7 years30.2%913
  • 8 to 11 years20.9%632
  • 12 years and over13.2%398
  • Age not given10%303

Weight of the animal

  • Under 5 kg (11 lb)10.7%322
  • 5 to 9.9 kg (11 to 22 lb)19.2%579
  • 10 to 24.9 kg (22 to 55 lb)29.2%883
  • 25 to 44.9 kg (55 to 99 lb)27.4%828
  • 45 kg and over (99 lb and over)3.3%99
  • Weight not given10.2%308

Breed, where the report gives one breed

A breed with many animals has many reports.

Route in the report

  • Oral72.6%2,191
  • Transdermal0.2%7
  • Topical0.2%5
  • Auricular (Otic)under 0.1%1
  • Intradermalunder 0.1%1
  • Intraocularunder 0.1%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

  • Reconcile

What the Green Book records give

Applications with an approval in force
1
Approved species
Dogs
Dose forms
Tablet (Chewable)
Routes
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.

Applications in the Green Book of 2 Nov 2026, pioneer applications (NADA) first
Brand nameActive ingredientsSponsorApproved speciesApplication
ReconcileFluoxetine hydrochloridePegasus Laboratories, Inc.DogsNADA 141-272

Next in the A to Z list

All drugs by active ingredient. Brand names A to Z

FDA pages for this drug

The site checked these addresses on . The links open in a new tab.

Cite this page

Pet Drug Reports. Fluoxetine hydrochloride: adverse event reports that FDA received. https://petdrugreports.com/drug/fluoxetine-hydrochloride/ Source: FDA Center for Veterinary Medicine, openFDA Animal and Veterinary adverse event reports, export of . Reports received through .

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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. 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 320 reports in the 12 months to June 2026. It received 309 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 3,019 reports received from December 2004 to June 2026, 81.3% are about a safety issue only. 12.1% are about a lack of expected effectiveness, alone or with a safety issue. 6.5% are about a defect of the product or its package.