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Roxee Medication Guide

Diphenhydramine

Medication reference facts with explicit FDA-approval, off-label, source-limited, and safety context. Roxee does not sell, prescribe, or dispense medications.

Both Source review pending Not FDA-approved for animals Rx required Official label facts Owner quick guide first
Start Symptom Intake Talk to a Vet / Find a Vet Near You

Veterinary professional?

Showing simplified owner view. Switch to Vet View for full technical detail.

Data freshness

Reference facts
Source review pending
No refresh timestamp yet

Roxee is still reviewing source support for this medication profile.

FDA applications
Regulatory match pending
No refresh timestamp yet

Roxee has safety or ingredient evidence for this medication, but a regulatory product/application match is still pending.

Safety reports
Safety data refreshed
Jun 21, 2026, 5:14 a.m.

openFDA reaction terms and case summaries are supporting evidence, not proof of causality.

Source timing details
Source timing details
  • Reference facts: Source Roxee | Refreshed Jun 22, 2026, 10:45 AM UTC
    The reference fact projection used for browse cards and quick facts.
  • openFDA reaction terms: Source FDA openFDA | Refreshed Jun 22, 2026, 10:45 AM UTC
  • openFDA case summaries: Source FDA openFDA | Refreshed Jun 22, 2026, 10:45 AM UTC
Image coming soon
Diphenhydramine

Diphenhydramine

Drug type: Generic ingredient • Generic profile • Not FDA-approved for animals

Both Rx required 90% reference complete

Species: Both

Approval status: Not FDA-approved as an animal drug. No FDA-approved animal-drug application is linked for this record. It may represent extra-label, human-drug, bulk-compounding, export-only, or otherwise unapproved animal-use source data; use only under veterinarian direction.

Medication Snapshot

Merged from the current Roxee medication system with field-level provenance, freshness, and completeness tracking.

Diphenhydramine

Antihistamine sometimes used for allergies/itching and mild allergic reactions; may cause mild sedation. Species commonly shown: Both.

Generic name
Diphenhydramine
Species
Both
Prescription
Prescription required
Completeness
90%
Validation
Incomplete

Indications / Uses

Antihistamine sometimes used for allergies/itching and mild allergic reactions; may cause mild sedation.

Administration / How To Give

Oral

Storage

Store at room temperature.

Warnings / Contraindications

Use caution with glaucoma, urinary retention, or certain cardiac conditions.

  • Use caution with glaucoma, urinary retention, or certain cardiac conditions.

Side Effects

Sedation, dry mouth, GI upset; occasional paradoxical excitement.

FAQ

Both

Yes. Roxee shows this as prescription-only.

Store at room temperature.

Related Medications

Cyclosporine Same category: Allergies / Itching Lokivetmab Same category: Allergies / Itching Oclacitinib Same category: Allergies / Itching Oclacitinib Maleate Same category: Allergies / Itching Prednisone Same category: Allergies / Itching Meloxicam Same category: Allergies / Itching

Source Transparency

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Pet Owner Quick Guide

Start here first for the safest next-step summary before the deeper medication detail.

Used for:

Antihistamine sometimes used for allergies/itching and mild allergic reactions; may cause mild sedation.

Dosing note:

Exact dosing depends on your pet's species, weight, and health status. Use your veterinarian's instructions for the exact dose and schedule.

What to watch for:

  • Use caution with glaucoma, urinary retention, or certain cardiac conditions
  • wobbly/unsteady walking (1 reports)
  • Loss of appetite (1 reports)
  • Hair loss (1 reports)

When to call the vet:

  • Repeated vomiting or diarrhea.
  • Severe lethargy (hard to wake, very low energy).
  • Collapse or fainting.
  • Trouble breathing.
  • Facial swelling or hives.
  • Blood in vomit or stool.

What to tell or ask your vet today:

  • Is this medicine the right fit for my pet’s current symptoms?
  • Which warning signs mean I should call back right away?
  • How should I handle missed doses or refusal to take the medicine?

Next actions

Talk to a Vet / Find a Vet Near You Save to pet meds Share page Review report evidence
Research brief

Medication Research Insights

A source-aware map of what to know, what is uncertain, and what to verify with your veterinarian.

Source Backed Signals

What to know

Evidence-backed context Limited

Roxee has limited cited overview evidence for Diphenhydramine; use the official documents and your veterinarian's instructions for product-specific decisions.

Source: openFDA case USA-USFDACVM-2025-US-075379
Safety signal coverage Reported signals

32 tracked reaction signals; 32 reported cases; 26 serious reports; 2 species groups. These are reporting and label-derived signals for interpretation with a veterinarian.

Source: openFDA case USA-USFDACVM-2025-US-075379
Interpretation guardrail Not causation

Adverse-event reports help form a watch list, but they do not prove the medication caused the reaction and they are not a risk ranking between medications.

Evidence tension

Stronger signal Label / review

Official labels, package inserts, and reviewed summaries carry more weight than isolated reports.

Source: openFDA case USA-USFDACVM-2025-US-075379
Weaker signal Reported data

Case reports and openFDA terms are useful for pattern awareness, but they are incomplete, can include multiple exposures, and do not estimate an individual pet's probability of harm.

Reaction signal map

Most reported reactions Top terms

Unsteady walking (ataxia) (1 reports), Loss of appetite (1 reports), Hair loss (1 reports), Elevated globulins (1 reports), Elevated gamma-glutamyl transferase (1 reports)

Body systems represented Signal grouping

Digestive (4), Skin & allergy (1), Neurologic (1), Behavior (3)

Explore supporting adverse reports

Species and breed lens

Species represented in reports Species lens

Dog (16 reports), Cat (16 reports)

Breed metadata in reports Metadata only

Domestic Shorthair (1), ['Great Pyrenees', 'Retriever - Labrador'] (1), ['Terrier - Jack Russell', 'Terrier - Bull - American Pit'] (1), ['Retriever - Golden', 'Poodle - Standard'] (1). These are report metadata, not proof that a breed is at higher risk.

What your vet may verify

Fit for this patient Vet check

Verify whether Diphenhydramine fits the pet's species, current diagnosis, age, weight, organ status, pregnancy/lactation status, and concurrent medications.

Evidence limitations Evidence review

Separate label-backed warnings from adverse-event reports and owner observations before changing the plan.

What to watch next

Watch list Owner-safe

Use caution with glaucoma, urinary retention, or certain cardiac conditions, wobbly/unsteady walking, Loss of appetite, Hair loss

Call sooner if Escalation

Repeated vomiting or diarrhea. Severe lethargy (hard to wake, very low energy). Collapse or fainting.

Bottom line: Use this Diphenhydramine brief as a structured watch list and source map, not as a reason to start, stop, or change treatment without your veterinarian.
Vet source depth
  1. openFDA case USA-USFDACVM-2025-US-075379 · adverse_reaction · adverse reactions
  2. Medication contraindications · safety_warning · warnings contraindications
  3. Structured Product Label · document · documents
  4. Structured Product Label · document · documents
  5. Structured Product Label · document · documents
  6. Structured Product Label · document · documents

Evidence

Review status / Updated / Sources

Review status: Clinical reviewer not listed

Updated: April 15, 2026, 10:04 AM UTC

Sources:
Safety & side effects

Side effects to monitor:

  • Use caution with glaucoma, urinary retention, or certain cardiac conditions
  • wobbly/unsteady walking
  • Loss of appetite
  • Hair loss

Most reported reactions:

  • Unsteady walking (ataxia) (1 reports)
  • Loss of appetite (1 reports)
  • Hair loss (1 reports)
Explore reported case details

Emergency warning signs:

  • Repeated vomiting or diarrhea.
  • Severe lethargy (hard to wake, very low energy).
  • Collapse or fainting.
  • Trouble breathing.
Talk to a Vet / Find a Vet Near You Start Symptom Intake

Vet Fast Scan

Source-backed clinical checkpoints for quick review.

FDA-labeled species
Not linked yet
Indication / use
Antihistamine sometimes used for allergies/itching and mild allergic reactions; may cause mild sedation.
Form / route / dose
Confirm product label and patient-specific plan.
Warnings
  • High: Use caution with glaucoma, urinary retention, or certain cardiac conditions.
Adverse-event caveat
openFDA adverse-event cases are reported signals. They are not verified, do not prove causation, and do not estimate a pet's individual risk.
Source docs

Quick Facts

Official label facts first, then secondary summaries. Marketing content is separated below.

Species: Both
Manufacturer: Manufacturer not confirmed
Identifiers:
NDC Package: 21091-695-01 NDC Package: 43655-002-01 NDC Package: 49427-329-45 NDC Package: 49427-329-57 NDC Package: 49427-330-45 NDC Package: 49427-330-57 NDC Package: 70782-200-08 NDC Package: 70782-201-12 NDC Package: 72087-021-10 NDC Package: 72087-022-20 NDC Package: 80547-116-50 NDC Package: 80547-128-50 NDC Product: 21091 NDC Product: 43655 NDC Product: 49427 NDC Product: 70782 NDC Product: 72087 NDC Product: 80547

Warnings / Contraindications

Use caution with glaucoma, urinary retention, or certain cardiac conditions.

  • High: Use caution with glaucoma, urinary retention, or certain cardiac conditions.
Source metadata:

Adverse Reactions

Snapshot first, detailed rows second. This section summarizes signal data and is not a diagnosis.

Reported case explorer

Filter stored openFDA reports by pet and report attributes. Counts describe reports in this data set, not risk.

Clear filters
openFDA adverse-event cases are reported signals. They are not verified, do not prove causation, and do not estimate a pet's individual risk.
Stored reports
20
Matching reports
4
Active filters
2
Selected filters
Reaction: Anaphylaxis Clear Body system: Digestive Clear
Reset
Drill into common report signals
Emesis (multiple) (5) Anaphylaxis (4) Hives (see also Skin) (4) Lethargy (see also Central nervous system depression in Neurological) (3) Other (18) Digestive (10) Skin & allergy (8) Neurologic (5)
Showing up to 50 matching reports.

USA-USFDACVM-2025-US-074149

Received 2025-12-12 · MSK · MSK

Serious
Species
Dog
Breed
Dachshund - Miniature
Size / weight
Under 10 lb (2.812 Kilogram)
Age
1-3 years (1 Year)
Sex
Female Intact
Region
USA
Reactions
Circulatory collapse (see also Neurological and Systemic disorders)Pale mucous membraneEmesis (multiple)Hives (see also Skin)Anaphylaxis
Body systems
NeurologicOtherDigestiveSkin & allergy
Outcomes
Ongoing

USA-USFDACVM-2025-US-071520

Received 2025-12-01 · MSK · MSK

Serious
Species
Dog
Breed
Bulldog - French
Size / weight
10-24 lb (10.795 Kilogram)
Age
1-3 years (3 Year)
Sex
Female Unknown
Region
USA
Reactions
VomitingBreathing difficultyCyanosisUrinary incontinenceAnaphylaxis
Body systems
DigestiveOther
Outcomes
Recovered/Normal

USA-USFDACVM-2025-US-070459

Received 2025-11-25 · MSK · MSK

Serious
Species
Dog
Breed
Dachshund - Miniature
Size / weight
10-24 lb (5.557 Kilogram)
Age
4-7 years (4 Year)
Sex
Female Unknown
Region
USA
Reactions
Emesis (multiple)Lateral recumbencyPale mucous membraneDry mucous membraneAnaphylaxisHives (see also Skin)Swollen muzzle
Body systems
DigestiveOtherSkin & allergy
Outcomes
Recovered/Normal

USA-USFDACVM-2025-US-069329

Received 2025-11-17 · MSK · MSK

Serious
Species
Cat
Breed
['Siamese', 'Cat (other)']
Size / weight
10-24 lb (5.352 Kilogram)
Age
4-7 years (4 Year)
Sex
Female Unknown
Region
USA
Reactions
AnaphylaxisPantingOpen mouth breathingElevated temperatureEmesis (multiple)HidingLethargy (see also Central nervous system depression in Neurological)Low blood pressureFacial swelling (see also Skin)Local erythema
Body systems
OtherDigestiveNeurologicSkin & allergy
Outcomes
Ongoing

Tap or hover a reaction to see what it means in plain language.

Tracked signals
32
Reported cases
32
Serious reports
26
Species represented
2
Grouped by Body System
Digestive (4) · Loss of appetite, Diarrhea, Decreased appetite Skin & allergy (1) · Hair loss Neurologic (1) · Unsteady walking (ataxia) Behavior (3) · Biting -aggression, Behavioral disorder (unspecified), Aggression Other (23) · Elevated globulins, Elevated gamma-glutamyl transferase, Elevated creatinine
Most Reported Reactions
Reaction Body system Cases Species Serious cases
Neurologic 1 Dog 1
Digestive 1 Dog 1
Skin & allergy 1 Dog 1
Other 1 Cat 1
Other 1 Cat 1
Other 1 Cat 1
Other 1 Cat 1
Other 1 Dog 1

Species coverage: Dog (16) Cat (16)

View detailed reaction table
Reaction Body system Species Seriousness Frequency Reports
Neurologic Dog Serious - 1
Digestive Dog Serious - 1
Skin & allergy Dog Serious - 1
Other Cat Serious - 1
Other Cat Serious - 1
Other Cat Serious - 1
Other Cat Serious - 1
Other Dog Serious - 1
Other Cat Non-serious - 1
Other Dog Serious - 1
Other Cat Serious - 1
Other Cat Serious - 1
Digestive Dog Non-serious - 1
Other Dog Serious - 1
Digestive Cat Non-serious - 1
Other Cat Serious - 1
Other Dog Serious - 1
Other Dog Serious - 1
Other Dog Serious - 1
Other Dog Serious - 1
Other Dog Serious - 1
Other Dog Serious - 1
Digestive Cat Serious - 1
Behavior Dog Serious - 1
Behavior Cat Non-serious - 1
Other Cat Serious - 1
Other Dog Non-serious - 1
Other Cat Serious - 1
Behavior Dog Non-serious - 1
Other Cat Serious - 1
Other Cat Serious - 1
Other Cat Serious - 1
Source metadata:

Storage & Handling

Store at room temperature.

Source Documents

The most useful source links appear first; full previews and metadata stay in the veterinary/professional layer.

Use original documents to confirm product-specific warnings, ingredients, and handling details with your veterinarian.

Vetadryl 30 SPL SPL · Structured Product Label Calmatrol SPL SPL · Structured Product Label Calmatrol SPL SPL · Structured Product Label

Full source previews and metadata remain in the veterinary/professional layer.

Owner handouts

0
No owner handouts linked yet.

Official label / PI

0
No official label or package insert links yet.

SPL

4

FOI

0
No FOI links yet.

Vetadryl 30 SPL

SPL · Structured Product Label

Open original
FDA Structured Product Label XML for Vetadryl 30. Use the source link for the full official labeling record.

Calmatrol SPL

SPL · Structured Product Label

Open original
FDA Structured Product Label XML for Calmatrol. Use the source link for the full official labeling record.

Calmatrol SPL

SPL · Structured Product Label

Open original
FDA Structured Product Label XML for Calmatrol. Use the source link for the full official labeling record.

Diphenhydramine HCL SPL

SPL · Structured Product Label

Open original
FDA Structured Product Label XML for Diphenhydramine HCL. Use the source link for the full official labeling record.
Source metadata:
Veterinary reference (advanced)

Canonical medication sections are above. This legacy block remains available for deeper cross-reference without cluttering the primary workflow.

At a Glance

Quick facts and links to official labeling and safety signals.

Data freshness
  • Reference facts: Source Roxee | Refreshed Jun 22, 2026, 10:45 AM UTC
    The reference fact projection used for browse cards and quick facts.
  • openFDA reaction terms: Source FDA openFDA | Refreshed Jun 22, 2026, 10:45 AM UTC
  • openFDA case summaries: Source FDA openFDA | Refreshed Jun 22, 2026, 10:45 AM UTC
Official (FDA)
Identity: Generic ingredient • No FDA branded products linked
No official FDA brand rows linked yet for this ingredient.
Manufacturer mapping: Multiple FDA labelers
Case-reported brands (openFDA): MSK
Catalog species: Both
Safety (openFDA)
Top reactions: Dog 60 • Cat 33 • View
Case summaries: 20 (showing 8) • View
openFDA reports are unverified and do not prove causation.
Diagnosis Codes

Diagnosis-code mappings are not available for this medication yet.

Counseling and Monitoring Highlights

Global Pet owner/Vet mode is controlled in the header. This section avoids duplicate in-page persona tabs.

Owner-facing counseling points
  • Use caution with glaucoma, urinary retention, or certain cardiac conditions. (Contraindication, High)
Top reaction signals
Unsteady walking (ataxia) (1) Loss of appetite (1) Hair loss (1) Elevated globulins (1) Elevated gamma-glutamyl transferase (1) Elevated creatinine (1) Elevated alanine aminotransferase (1) Ear infection NOS (1)

Identifiers & Packages

Normalized identifiers (NDC/NADA/ANADA) and package metadata from regulator listings.

Identifiers
NDC Package: 21091-695-01 NDC Package: 43655-002-01 NDC Package: 49427-329-45 NDC Package: 49427-329-57 NDC Package: 49427-330-45 NDC Package: 49427-330-57 NDC Package: 70782-200-08 NDC Package: 70782-201-12 NDC Package: 72087-021-10 NDC Package: 72087-022-20 NDC Package: 80547-116-50 NDC Package: 80547-128-50 NDC Product: 21091 NDC Product: 43655 NDC Product: 49427 NDC Product: 70782 NDC Product: 72087 NDC Product: 80547
Package NDC Product NDC Form / Route Status
21091-695-01 21091 -
43655-002-01 43655 -
49427-329-45 49427 -
49427-329-57 49427 -
49427-330-45 49427 -
49427-330-57 49427 -
70782-200-08 70782 -
70782-201-12 70782 -
72087-021-10 72087 -
72087-022-20 72087 -
80547-116-50 80547 -
80547-128-50 80547 -

Enriched Documents

Documents are tiered by source trust: Official, Clinical, Manufacturer, Marketing.

  • Vetadryl 30 SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • Calmatrol SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • Calmatrol SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • Diphenhydramine HCL SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.

Data Sources & Change Log

Every non-trivial field is expected to include provenance and update timestamps.

Official 4 Clinical 120 Manufacturer 0 Marketing 0
Current Field Facts
  • contraindications: Use caution with glaucoma, urinary retention, or certain cardiac conditions. (Clinical, 2026-06-22)
  • contraindications: Use caution with glaucoma, urinary retention, or certain cardiac conditions. (Clinical, 2026-06-22)
  • contraindications: Use caution with glaucoma, urinary retention, or certain cardiac conditions. (Clinical, 2026-06-21)
  • contraindications: Use caution with glaucoma, urinary retention, or certain cardiac conditions. (Clinical, 2026-06-20)
  • contraindications: Use caution with glaucoma, urinary retention, or certain cardiac conditions. (Clinical, 2026-06-13)
  • contraindications: Use caution with glaucoma, urinary retention, or certain cardiac conditions. (Clinical, 2026-06-12)
  • contraindications: Use caution with glaucoma, urinary retention, or certain cardiac conditions. (Clinical, 2026-06-12)
  • contraindications: Use caution with glaucoma, urinary retention, or certain cardiac conditions. (Clinical, 2026-06-11)
  • contraindications: Use caution with glaucoma, urinary retention, or certain cardiac conditions. (Clinical, 2026-06-11)
  • contraindications: Use caution with glaucoma, urinary retention, or certain cardiac conditions. (Clinical, 2026-06-10)
  • contraindications: Use caution with glaucoma, urinary retention, or certain cardiac conditions. (Clinical, 2026-06-08)
  • contraindications: Use caution with glaucoma, urinary retention, or certain cardiac conditions. (Clinical, 2026-06-07)
  • contraindications: Use caution with glaucoma, urinary retention, or certain cardiac conditions. (Clinical, 2026-06-06)
  • contraindications: Use caution with glaucoma, urinary retention, or certain cardiac conditions. (Clinical, 2026-06-05)
  • contraindications: Use caution with glaucoma, urinary retention, or certain cardiac conditions. (Clinical, 2026-06-04)
  • contraindications: Use caution with glaucoma, urinary retention, or certain cardiac conditions. (Clinical, 2026-06-03)
  • contraindications: Use caution with glaucoma, urinary retention, or certain cardiac conditions. (Clinical, 2026-06-02)
  • contraindications: Use caution with glaucoma, urinary retention, or certain cardiac conditions. (Clinical, 2026-06-01)
  • contraindications: Use caution with glaucoma, urinary retention, or certain cardiac conditions. (Clinical, 2026-06-01)
  • contraindications: Use caution with glaucoma, urinary retention, or certain cardiac conditions. (Clinical, 2026-05-31)
Recent Revisions
  • side_effects updated 2026-06-22 10:45 by etl_backfill • Backfilled from existing medication fields
  • contraindications updated 2026-06-22 10:45 by etl_backfill • Backfilled from existing medication fields
  • usage updated 2026-06-22 10:45 by etl_backfill • Backfilled from existing medication fields
  • side_effects updated 2026-06-22 10:04 by etl_backfill • Backfilled from existing medication fields
  • contraindications updated 2026-06-22 10:04 by etl_backfill • Backfilled from existing medication fields
  • usage updated 2026-06-22 10:04 by etl_backfill • Backfilled from existing medication fields
  • side_effects updated 2026-06-21 05:18 by etl_backfill • Backfilled from existing medication fields
  • contraindications updated 2026-06-21 05:18 by etl_backfill • Backfilled from existing medication fields
  • usage updated 2026-06-21 05:18 by etl_backfill • Backfilled from existing medication fields
  • side_effects updated 2026-06-20 20:58 by etl_backfill • Backfilled from existing medication fields
  • contraindications updated 2026-06-20 20:58 by etl_backfill • Backfilled from existing medication fields
  • usage updated 2026-06-20 20:58 by etl_backfill • Backfilled from existing medication fields
  • side_effects updated 2026-06-13 11:33 by etl_backfill • Backfilled from existing medication fields
  • contraindications updated 2026-06-13 11:33 by etl_backfill • Backfilled from existing medication fields
  • usage updated 2026-06-13 11:33 by etl_backfill • Backfilled from existing medication fields
  • side_effects updated 2026-06-12 10:42 by etl_backfill • Backfilled from existing medication fields
  • contraindications updated 2026-06-12 10:42 by etl_backfill • Backfilled from existing medication fields
  • usage updated 2026-06-12 10:42 by etl_backfill • Backfilled from existing medication fields
  • side_effects updated 2026-06-12 10:04 by etl_backfill • Backfilled from existing medication fields
  • contraindications updated 2026-06-12 10:04 by etl_backfill • Backfilled from existing medication fields

Usage

Antihistamine sometimes used for allergies/itching and mild allergic reactions; may cause mild sedation.

Contraindications

Use caution with glaucoma, urinary retention, or certain cardiac conditions.

Side Effects

Sedation, dry mouth, GI upset; occasional paradoxical excitement.

Source: FDA openFDA • Reference

Top Reported Reactions (openFDA)

De-duplicated reaction terms grouped by body system from FDA openFDA reports (not verified; does not prove causation).

Digestive
Loss of appetite (1) • Dog Diarrhea (1) • Dog Decreased appetite (1) • Cat Blood in vomit (1) • Cat

Showing top 5 for Digestive.

Skin & allergy
Hair loss (1) • Dog

Showing top 5 for Skin & allergy.

Neurologic
Unsteady walking (1) • Dog

Showing top 5 for Neurologic.

Behavior
Biting -aggression (1) • Dog Behavioral disorder (1) • Cat Aggression (1) • Dog

Showing top 5 for Behavior.

Other
Elevated globulins (1) • Cat Elevated gamma-glutamyl transferase (1) • Cat Elevated creatinine (1) • Cat Elevated alanine aminotransferase (1) • Cat Ear infection NOS (1) • Dog
Show more (18)
Dullness (1) • Cat Dry mucous membrane (1) • Dog Discomfort NOS (1) • Cat Dilated pupils (1) • Cat Decreased haematocrit (1) • Dog Death (1) • Cat Cyanosis (1) • Dog Crust (1) • Dog Circulatory collapse (1) • Dog Bumps on skin (1) • Dog Breathing difficulty (1) • Dog Blood loss NOS (1) • Dog Aspiration pneumonia (1) • Cat Application site scar (1) • Dog Anaphylaxis (1) • Cat Abnormal radiograph finding (1) • Cat Abnormal histology NOS (1) • Cat Abnormal cytology (1) • Cat

Showing top 5 for Other.

Data source: FDA openFDA Animal & Veterinary adverse event reports.

Adverse Event Case Summaries (openFDA)

These are individual FDA adverse event reports. They are unverified and do not prove the medication caused the reaction.

Cat, Domestic Shorthair, Male, 7 year, 8.618 kilogram • Drug: MSK, Unassigned, Oral, Frequency: 12 per hour • Reactions: Injection site hair loss, Reddening of the skin, Weight loss, Skin lesion NOS, Wound… • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2025-US-075379
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Male
  • Age: 7.00 Year
  • Weight: 8.618 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Oral
  • Form: Unassigned
  • Frequency: 12 per hour
Reactions Reported:
Injection site hair loss Reddening of the skin Weight loss Skin lesion NOS Wound Abnormal cytology Discomfort NOS Skin necrosis Itching Facial swelling (possible allergy) Facial rash
Outcomes: Ongoing

Dog, ['Great Pyrenees', 'Retriever - Labrador'], Female, 31.661 kilogram • Drug: MSK, Unassigned, Unknown • Reactions: Vomiting • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2025-US-075148
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Female
  • Weight: 31.661 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Unknown
  • Form: Unassigned
Reactions Reported:
Vomiting
Outcomes: Ongoing

Dog, ['Terrier - Jack Russell', 'Terrier - Bull - American Pit'], Female, 1 year, 17.236 kilogram • Drug: MSK, Unassigned, Unknown • Reactions: Vomiting, Hives, Reddening of the skin, Skin irritation, Urine leakage… • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2025-US-074361
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Female
  • Age: 1.00 Year
  • Weight: 17.236 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Unknown
  • Form: Unassigned
Reactions Reported:
Vomiting Hives Reddening of the skin Skin irritation Urine leakage Hypersensitivity reaction
Outcomes: Ongoing

Dog, ['Retriever - Golden', 'Poodle - Standard'], Male, 7 year, 43.273 kilogram • Drug: MSK, Unassigned, Unknown • Reactions: Thrombocytopenia, Blood loss NOS, Skin petechiae, Death • Outcome: Died

  • Report ID: USA-USFDACVM-2025-US-074431
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Male
  • Age: 7.00 Year
  • Weight: 43.273 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Unknown
  • Form: Unassigned
Reactions Reported:
Thrombocytopenia Blood loss NOS Skin petechiae Death
Outcomes: Died

Dog, Terrier - Bull - American Pit, Male, 1 year, 33.339 kilogram • Drug: MSK, Tablet, Oral, Dose: 75 Milligram per animal • Reactions: Aggression • Outcome: Recovered/Normal

  • Report ID: USA-USFDACVM-2025-US-074416
  • Serious AE: No
  • Treated For AE: No
  • Sex: Male
  • Age: 1.00 Year
  • Weight: 33.339 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Oral
  • Form: Tablet
  • Dose: 75 Milligram per animal
Reactions Reported:
Aggression
Outcomes: Recovered/Normal

Dog, Terrier - Boston, Male, 9.75 year, 17.83 kilogram • Drug: MSK, Unassigned, Oral • Reactions: Proteinuria, Hypoalbuminaemia • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2025-US-074249
  • Serious AE: No
  • Treated For AE: No
  • Sex: Male
  • Age: 9.75 Year
  • Weight: 17.830 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Oral
  • Form: Unassigned
Reactions Reported:
Proteinuria Hypoalbuminaemia
Outcomes: Ongoing

Dog, ['Bichon Frise', 'Chihuahua'], Female, 15 year, 3.493 kilogram • Drug: MSK, Unassigned, Unknown, Frequency: 12 per hour • Reactions: Seizure NOS, Unsteady walking (ataxia), Urinary incontinence • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2025-US-074064
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Female
  • Age: 15.00 Year
  • Weight: 3.493 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Unknown
  • Form: Unassigned
  • Frequency: 12 per hour
Reactions Reported:
Seizure NOS Unsteady walking (ataxia) Urinary incontinence
Outcomes: Ongoing

Dog, Shih Tzu, Female, 11.68 year, 6.53 kilogram • Drug: MSK, Parenteral • Reactions: Not eating, Periorbital oedema, Fever, Local swelling, Nasal discharge… • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2025-US-074693
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Female
  • Age: 11.68 Year
  • Weight: 6.530 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Parenteral
Reactions Reported:
Not eating Periorbital oedema Fever Local swelling Nasal discharge Stridor Face and neck swelling Sneezing Respiratory tract disorder NOS Biting -aggression
Outcomes: Ongoing

Data source: FDA openFDA Animal & Veterinary adverse event reports.

Overdose Information

Overdose causes extreme drowsiness, tremors, seizures, or hyperexcitability. In severe cases, respiratory failure is possible. Treat with IV fluids, seizure control.

Storage & Handling

Store at room temperature.

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