Pet Drug Reports

Clomipramine Hydrochloride (Clomicalm)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.

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From February 1999 to June 2026, FDA received 2,457 adverse event reports that name a drug with clomipramine hydrochloride as its active ingredient. Of the 2,457 reports, 1,512 (61.5%) are about dogs. 234 reports are about people who were exposed to the drug (9.5%).

In January to March 2026, FDA received 12 reports that name this drug. The signs that appear in the largest number of the 2,457 reports are "Tablets, Abnormal", "Accidental exposure" and "Depression". A report is not proof that a drug caused a sign.

Reports that name this drug fell by 7.0% 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 61.5% of the reports that name this drug, and 72.6% of all reports.

Since the last update of the FDA data

The latest update of the FDA data, recorded on , 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 clomipramine hydrochloride: 11 dog, 0 cat, 0 horse, 1 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 2,457 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. Tablets, Abnormal[a product quality report, not a sign in an animal]18.3%450 reports
  2. Accidental exposure[exposure that was not intended]16.5%406 reports
  3. Depression[dull, quiet or withdrawn]14.2%350 reports
  4. Vomiting12.6%310 reports
  5. Uncoded sign[a sign with no matching dictionary term]10.4%256 reports
  6. Elevated alanine aminotransferase (ALT)[a liver enzyme above the normal range]8.3%204 reports
  7. Anorexia[not eating]7.7%189 reports
  8. Unclassifiable adverse event[event that fits no dictionary term]7.4%183 reports
  9. Elevated serum alkaline phosphatase (SAP)[a liver and bone enzyme above the normal range]7.2%176 reports
  10. Lack of efficacy - NOS[the product did not have the expected effect]6.6%163 reports
  11. Diarrhoea[diarrhea]5.7%139 reports
  12. Feeling depressed5.3%130 reports
  13. Aggression4.6%113 reports
  14. Ataxia[unsteady, uncoordinated movement]3.9%95 reports
Show the next 16 signs
  1. Lethargy[unusually tired or inactive]3.7%92 reports
  2. Elevated total bilirubin[bilirubin above the normal range]3.5%87 reports
  3. Nausea3.5%87 reports
  4. Elevated aspartate aminotransferase (AST)[a liver and muscle enzyme above the normal range]3.3%80 reports
  5. Vocalisation[crying out or unusual noise]3.2%78 reports
  6. Behavioural disorder NOS[behaviour change, type not specified]3.1%75 reports
  7. Trembling2.9%71 reports
  8. Weight loss2.8%69 reports
  9. Polydipsia[drinking more than usual]2.6%65 reports
  10. Mydriasis[dilated pupils]2.5%62 reports
  11. Other abnormal test result NOS[abnormal laboratory result, type not specified]2.3%57 reports
  12. Convulsion[seizure]2.3%56 reports
  13. Elevated gamma-glutamyl transferase (GGT)[a liver enzyme above the normal range]2.3%56 reports
  14. Tachycardia[fast heart rate]2.2%55 reports
  15. Polyuria[passing more urine than usual]1.9%47 reports
  16. Hyperactivity1.8%43 reports

The list shows 30 of 761 coded signs. A report is not proof that a drug caused a sign. Download all signs (CSV)

Reports by species

  • Dog61.5%1,512
  • Human exposure9.5%234
  • Cat5%123
  • Other Birds0.1%2
  • Otherunder 0.1%1

The share is of all 2,457 reports that name clomipramine hydrochloride. The other reports give a different species or no species.

Reports for each month, Jul 2021 to Jun 2026

Dog143 reports. Largest count in one month: 7 (Dec 2024)
Cat11 reports

No chart: no month has 5 or more reports.

Horse0 reports

No chart: no month has 5 or more reports.

Other or not given29 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 clomipramine hydrochloride, by the year in which FDA received them and by species
YearDogCatHorseOther or not givenAll species
20261720120
20253530543
20242930537
20232630736
20222400731
202122101235
202024401341
20194230651
201850201870
201733201348
201645301866
201533301450
201434501655
201341901262
20125420249305
201153401875
20104240551
200952501572
200862701483
2007765022103
2006868034128
200513010039179
200416415096275
2003927082181
200229505993
200136301251
200071301488
19991102016128

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/Normal7.4%181
  • Recovered with Sequela[recovered, with a lasting effect]0.6%14
  • Ongoing5.9%146
  • Died2.6%64
  • Euthanized0.4%10
  • Outcome Unknown9.7%239

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 2,457 reports that name clomipramine hydrochloride.

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

Kind of report

  • Safety issue70.6%1,735
  • Lack of expected effectiveness2.8%68
  • Both safety and lack of expected effectiveness2%50
  • Manufacturing or product defect24.6%604
  • Other0%0

595 reports say if the event was serious. 38.8% 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 year3.7%90
  • 1 to 3 years19.3%474
  • 4 to 7 years20%492
  • 8 to 11 years14.8%364
  • 12 years and over13.2%324
  • Age not given29%713

Weight of the animal

  • Under 5 kg (11 lb)9.4%231
  • 5 to 9.9 kg (11 to 22 lb)13.1%321
  • 10 to 24.9 kg (22 to 55 lb)22.8%559
  • 25 to 44.9 kg (55 to 99 lb)18.4%452
  • 45 kg and over (99 lb and over)5.2%127
  • Weight not given31.2%767

Breed, where the report gives one breed

A breed with many animals has many reports.

Route in the report

  • Oral73.8%1,814
  • Respiratory (Inhalation)0.1%2
  • Ophthalmicunder 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

  • Clomicalm

What the Green Book records give

Applications with an approval in force
3
Approved species
Dogs
Dose forms
Tablet
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
ClomicalmClomipramine HydrochlorideVirbac AH, Inc.DogsNADA 141-120
Clomipramine Hydrochloride TabletsClomipramine HydrochlorideMizner Bioscience LLCDogsANADA 200-635
Clomipramine Hydrochloride TabletsClomipramine HydrochlorideFelix Pharmaceuticals Pvt. Ltd.DogsANADA 200-825

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. Clomipramine Hydrochloride: adverse event reports that FDA received. https://petdrugreports.com/drug/clomipramine-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 40 reports in the 12 months to June 2026. It received 43 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 2,457 reports received from February 1999 to June 2026, 70.6% are about a safety issue only. 4.8% are about a lack of expected effectiveness, alone or with a safety issue. 24.6% are about a defect of the product or its package.