Pet Drug Reports

Phenylpropanolamine hydrochloride (Proin)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 January 2013 to June 2026, FDA received 1,007 adverse event reports that name a drug with phenylpropanolamine hydrochloride as its active ingredient. Of the 1,007 reports, 936 (92.9%) are about dogs.

In January to March 2026, FDA received 45 reports that name this drug. The signs that appear in the largest number of the 1,007 reports are "Lack of efficacy - NOS", "Vomiting" and "Lethargy". A report is not proof that a drug caused a sign.

Reports that name this drug rose by 39.4% 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 92.9% 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 36 to 45.
  • Dog: from 36 to 43.

January to March 2026 is the latest closed quarter in the data. In that quarter FDA received 45 reports that name phenylpropanolamine hydrochloride: 43 dog, 0 cat, 0 horse, 2 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 1,007 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]28.6%288 reports
  2. Vomiting17.2%173 reports
  3. Lethargy[unusually tired or inactive]12.5%126 reports
  4. Panting10.1%102 reports
  5. Diarrhoea[diarrhea]9.6%97 reports
  6. Emesis (multiple)[vomiting more than once]6.3%63 reports
  7. Behavioural disorder NOS[behaviour change, type not specified]5%50 reports
  8. Anorexia[not eating]4.6%46 reports
  9. Restlessness4.4%44 reports
  10. Agitation4.1%41 reports
  11. Urinary incontinence3.6%36 reports
  12. Decreased appetite3.5%35 reports
  13. Underfilling, Package[a product quality report, not a sign in an animal]3.5%35 reports
  14. Seizure NOS[seizure, type not specified]3.3%33 reports
Show the next 16 signs
  1. Anxiety2.9%29 reports
  2. Elevated alanine aminotransferase (ALT)[a liver enzyme above the normal range]2.9%29 reports
  3. Hypertension[high blood pressure]2.8%28 reports
  4. Ataxia[unsteady, uncoordinated movement]2.7%27 reports
  5. Polydipsia[drinking more than usual]2.7%27 reports
  6. Weight loss2.7%27 reports
  7. Underdose[less than the labelled amount was given]2.5%25 reports
  8. Urinary tract infection2.4%24 reports
  9. Drooling2.2%22 reports
  10. Dilated pupils2.1%21 reports
  11. Emesis[vomiting]2.1%21 reports
  12. Death by euthanasia[the animal was euthanized]2%20 reports
  13. Pacing1.9%19 reports
  14. Not eating1.8%18 reports
  15. Tablets, Abnormal[a product quality report, not a sign in an animal]1.8%18 reports
  16. Elevated blood urea nitrogen (BUN)[a kidney value above the normal range]1.7%17 reports

The list shows 30 of 592 coded signs. A report is not proof that a drug caused a sign. Download all signs (CSV)

Reports by species

  • Dog92.9%936
  • Other0.5%5
  • Human exposure0.3%3
  • Dormouse0.1%1

The share is of all 1,007 reports that name phenylpropanolamine hydrochloride. The other reports give a different species or no species.

Reports for each month, Jul 2021 to Jun 2026

Dog568 reports. Largest count in one month: 27 (Apr 2026)
Cat0 reports

No chart: no month has 5 or more reports.

Horse0 reports

No chart: no month has 5 or more reports.

Other or not given49 reports. Largest count in one month: 6 (Oct 2025)

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 phenylpropanolamine hydrochloride, by the year in which FDA received them and by species
YearDogCatHorseOther or not givenAll species
20269500499
20251360018154
2024137008145
2023920010102
20227300578
202189001099
20202900016306
201960006
201830003
201740004
201620002
201550005
201340004

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/Normal39.1%394
  • Recovered with Sequela[recovered, with a lasting effect]0.8%8
  • Ongoing8.2%83
  • Died1.5%15
  • Euthanized2.1%21
  • Outcome Unknown42.2%425

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 1,007 reports that name phenylpropanolamine hydrochloride.

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

Kind of report

  • Safety issue63.1%635
  • Lack of expected effectiveness0.9%9
  • Both safety and lack of expected effectiveness27.9%281
  • Manufacturing or product defect8.1%82
  • Other0%0

945 reports say if the event was serious. 34.2% 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 year0.8%8
  • 1 to 3 years11.9%120
  • 4 to 7 years24.7%249
  • 8 to 11 years25.6%258
  • 12 years and over26.1%263
  • Age not given10.8%109

Weight of the animal

  • Under 5 kg (11 lb)2.5%25
  • 5 to 9.9 kg (11 to 22 lb)9.8%99
  • 10 to 24.9 kg (22 to 55 lb)30.6%308
  • 25 to 44.9 kg (55 to 99 lb)39.1%394
  • 45 kg and over (99 lb and over)6.3%63
  • Weight not given11.7%118

Breed, where the report gives one breed

A breed with many animals has many reports.

Route in the report

  • Oral86.7%873
  • Other0.1%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

  • Proin

What the Green Book records give

Applications with an approval in force
3
Approved species
Dogs
Dose forms
Chewable Tablets, Scored Chewable Tablets, 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
Proin Chewable TabletsPhenylpropanolamine hydrochloridePegasus Laboratories, Inc.DogsNADA 141-324
Proin ERPhenylpropanolamine hydrochloridePegasus Laboratories, Inc.DogsNADA 141-517
Phenylpropanolamine HydrochloridePhenylpropanolamine hydrochlorideZyVet Animal Health, Inc.DogsANADA 200-787

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. Phenylpropanolamine hydrochloride: adverse event reports that FDA received. https://petdrugreports.com/drug/phenylpropanolamine-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 184 reports in the 12 months to June 2026. It received 132 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 1,007 reports received from January 2013 to June 2026, 63.1% are about a safety issue only. 28.8% are about a lack of expected effectiveness, alone or with a safety issue. 8.1% are about a defect of the product or its package.