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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

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
Aug 6, 2026, 7:49 p.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 Jul 22, 2026, 7:08 PM UTC
    The reference fact projection used for browse cards and quick facts.
  • openFDA reaction terms: Source FDA openFDA | Refreshed Aug 6, 2026, 7:52 PM UTC
  • openFDA case summaries: Source FDA openFDA | Refreshed Aug 6, 2026, 7:52 PM UTC
Illustration placeholder
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.

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

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-2026-US-006203
Safety signal coverage Reported signals

32 tracked reaction signals; 32 reported cases; 29 serious reports; 2 species groups. These are reporting and label-derived signals for interpretation with a veterinarian.

Source: openFDA case USA-USFDACVM-2026-US-006203
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-2026-US-006203
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), Cutaneous emphysema (1 reports), Crust (1 reports)

Body systems represented Signal grouping

Digestive (3), Skin & allergy (1), Neurologic (2), Behavior (3)

Explore supporting adverse reports

Species and breed lens

Species represented in reports Species lens

Dog (20 reports), Cat (12 reports)

Breed metadata in reports Metadata only

Crossbred Canine/dog (2), Terrier - Jack Russell (1), Shih Tzu (1), Terrier - Bull - Staffordshire (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-2026-US-006203 · 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

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.

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
39
Matching reports
39
Active filters
0
Reset
Showing up to 50 matching reports.

USA-USFDACVM-2026-US-014459

Received 2026-03-24 · MSK · MSK

Serious
Species
Dog
Breed
Terrier - Jack Russell
Size / weight
10-24 lb (6.409 Kilogram)
Age
4-7 years (5 Year)
Sex
Male Neutered
Region
USA
Reactions
AnaphylaxisLateral recumbencyTachypnoeaCyanotic mucous membranes
Body systems
Other
Outcomes
Recovered/Normal

USA-USFDACVM-2026-US-014246

Received 2026-03-24 · MSK · MSK

Non-serious
Species
Dog
Breed
Shih Tzu
Size / weight
Under 10 lb (2.49 Kilogram)
Age
Under 1 year (16 Week)
Sex
Female Intact
Region
USA
Reactions
Facial swelling (see also Skin)Vomiting
Body systems
Skin & allergyDigestive
Outcomes
Outcome Unknown

USA-USFDACVM-2026-US-013479

Received 2026-03-24 · MSK · MSK

Serious
Species
Dog
Breed
Terrier - Bull - Staffordshire
Size / weight
50-99 lb (33.611 Kilogram)
Age
1-3 years (2 Year)
Sex
Female Unknown
Region
USA
Reactions
Facial swelling (see also Skin)Hypersensitivity reactionEmesis (multiple)Bloody diarrhoeaAtaxiaElevated total bilirubinElevated alanine aminotransferase (ALT)Elevated blood urea nitrogen (BUN)Lethargy (see also Central nervous system depression in Neurological)Intentional misuse
Body systems
Skin & allergyOtherDigestiveNeurologic
Outcomes
Ongoing

USA-USFDACVM-2026-US-012798

Received 2026-03-20 · MSK · MSK

Serious
Species
Dog
Breed
Crossbred Canine/dog
Size / weight
25-49 lb (14.969 Kilogram)
Age
1-3 years (1 Year)
Sex
Female Unknown
Region
USA
Reactions
VocalisationRestlessnessIntentional misuse
Body systems
Other
Outcomes
Ongoing

USA-USFDACVM-2026-US-014559

Received 2026-03-17 · MSK · MSK

Serious
Species
Dog
Breed
Crossbred Canine/dog
Size / weight
50-99 lb (37.648 Kilogram)
Age
4-7 years (7 Year)
Sex
Male Neutered
Region
USA
Reactions
RegurgitationMalaiseWobblinessBalance problemWeaknessConfusionCircling - neurological disorder (see also Behavioural disorders)VomitingDecreased appetiteDecreased bowel movementsLeukocytosis NOSNeutrophiliaMonocytosisEosinopeniaHypoproteinaemiaReduced globulinsElevated alanine aminotransferase (ALT)Elevated serum alkaline phosphatase (ALP)
Body systems
OtherNeurologicDigestive
Outcomes
Ongoing

USA-USFDACVM-2026-US-012963

Received 2026-03-16 · MSK · MSK

Serious
Species
Dog
Breed
Great Pyrenees
Size / weight
50-99 lb (40.37 Kilogram)
Age
8+ years (13 Year)
Sex
Male Unknown
Region
USA
Reactions
Vestibular disorder NOSAtaxiaNystagmusTympanic rupture
Body systems
OtherNeurologic
Outcomes
Ongoing

USA-USFDACVM-2026-US-012695

Received 2026-03-13 · MSK · MSK

Serious
Species
Dog
Breed
Dalmatian
Size / weight
50-99 lb (36.741 Kilogram)
Age
8+ years (1 Year)
Sex
Male Neutered
Region
USA
Reactions
AgitationDroolingFebrilePantingAnaphylaxisUnwellDecreased appetiteUrinary incontinenceVomitingDiarrhoeaLeukocytosis NOSNeutrophiliaLymphocytosisMonocytosisElevated globulinsElevated serum alkaline phosphatase (ALP)Anaemia NOSElevated alanine aminotransferase (ALT)Elevated C-reactive proteinAggressionUrolithiasisAutoimmune disorder NOSThrombocytopenia
Body systems
OtherDigestiveBehavior
Outcomes
Ongoing

USA-USFDACVM-2026-US-011895

Received 2026-03-11 · MSK · MSK

Serious
Species
Cat
Breed
Domestic Shorthair
Size / weight
Under 10 lb (4.377 Kilogram)
Age
1-3 years (1.5 Year)
Sex
Female Unknown
Region
USA
Reactions
VomitingLocalised pain NOS (see other SOCs for specific pain)Limb non-weight bearingLethargy (see also Central nervous system depression in Neurological)Not eatingHead tremorIncreased respiratory ratePlantigrade postureLimb weaknessProprioception deficitCutaneous emphysemaAbnormal radiograph findingKnuckling
Body systems
DigestiveOtherNeurologic
Outcomes
Ongoing

USA-USFDACVM-2026-US-011648

Received 2026-03-10 · MSK · MSK

Serious
Species
Cat
Breed
Domestic Shorthair
Size / weight
10-24 lb (5.126 Kilogram)
Age
4-7 years (5 Year)
Sex
Female Neutered
Region
USA
Reactions
Emesis (multiple)Weight lossLethargy (see also Central nervous system depression in Neurological)Blood in vomitAbnormal ultrasound findingWeaknessDecreased appetiteINEFFECTIVE, ANTIEMETICDigestive tract disorder NOS
Body systems
DigestiveOtherNeurologic
Outcomes
Ongoing

USA-USFDACVM-2026-US-011341

Received 2026-03-05 · MSK · MSK

Non-serious
Species
Cat
Breed
Domestic Shorthair
Size / weight
10-24 lb (4.881 Kilogram)
Age
4-7 years (5 Year)
Sex
Female Unknown
Region
USA
Reactions
VomitingAnorexiaDecreased bowel movementsElevated liver enzymes NOSIntentional misuse
Body systems
DigestiveOther
Outcomes
Ongoing

USA-USFDACVM-2026-US-008882

Received 2026-03-02 · MSK · MSK

Serious
Species
Cat
Breed
Domestic Shorthair
Size / weight
10-24 lb (5.461 Kilogram)
Age
4-7 years (5 Year)
Sex
Male Neutered
Region
USA
Reactions
AnaphylaxisEmesis (multiple)LimpnessLateral recumbencyPale mucous membranePantingInvoluntary defecationLow blood pressureFoaming at the mouthLethargy (see also Central nervous system depression in Neurological)Not eatingDiarrhoea
Body systems
OtherDigestiveNeurologic
Outcomes
Recovered/Normal

USA-USFDACVM-2026-US-008769

Received 2026-02-28 · MSK · MSK

Serious
Species
Cat
Breed
Russian
Size / weight
Under 10 lb (4.3 Kilogram)
Age
8+ years (19 Year)
Sex
Male Neutered
Region
USA
Reactions
Not drinkingNot eatingDullnessAnaemia NOSCardiac disorder NOSHeart murmurPale mucous membraneAtaxiaOliguriaRenal failureDeath by euthanasiaInappetenceLethargy (see also Central nervous system depression in Neurological)AscitesThird eyelid protrusionLateral recumbencyAcute renal failureDehydrationProlonged capillary refill timeHyperglycaemiaSplenic neoplasm NOSHead bobbingElevated blood urea nitrogen (BUN)Elevated creatinineAbnormal radiograph findingAzotaemiaDecreased packed cell volume (PCV)DullHypernatraemia
Body systems
OtherNeurologic
Outcomes
Euthanized

USA-USFDACVM-2026-US-009390

Received 2026-02-23 · MSK · MSK

Non-serious
Species
Dog
Breed
Terrier - Bull - Staffordshire
Size / weight
50-99 lb (30.617 Kilogram)
Age
8+ years (8 Year)
Sex
Male Neutered
Region
USA
Reactions
Swollen limbInjection site inflammationLack of efficacy (neoplasia, no remission)
Body systems
OtherEffectiveness
Outcomes
Recovered/Normal

USA-USFDACVM-2026-US-008346

Received 2026-02-23 · MSK · MSK

Non-serious
Species
Cat
Breed
Domestic Shorthair
Size / weight
Under 10 lb (4.4 Kilogram)
Age
4-7 years (4 Year)
Sex
Female Neutered
Region
USA
Reactions
MonocytosisLow creatinineGait abnormalityMuscle atrophy (see also Muscle wasting)Unkempt hair coatPlantigrade postureSedationGreasy skin
Body systems
Other
Outcomes
Ongoing

USA-USFDACVM-2026-US-011611

Received 2026-02-14 · MSK · MSK

Serious
Species
Cat
Breed
Domestic Shorthair
Size / weight
10-24 lb (6.3 Kilogram)
Age
4-7 years (6 Year)
Sex
Male Neutered
Region
USA
Reactions
DeathDullNot himself/herselfHead pressingHypotensionUnresponsive to stimuli
Body systems
Other
Outcomes
Died

USA-USFDACVM-2026-US-006203

Received 2026-02-10 · MSK · MSK

Serious
Species
Dog
Breed
Mountain Dog - Bernese
Size / weight
50-99 lb (35.698 Kilogram)
Age
4-7 years (7 Year)
Sex
Female Unknown
Region
USA
Reactions
Lethargy (see also Central nervous system depression in Neurological)InappetenceSwollen lip (see also Skin)Localised pain NOS (see other SOCs for specific pain)Ocular dischargeNot drinkingSmelly breathLip smackingWalking difficultyAbdominal painDrooping eyelidReluctant to moveOral ulcerationTongue ulcerationIntentional misuse
Body systems
NeurologicOther
Outcomes
Ongoing

USA-USFDACVM-2026-US-005800

Received 2026-02-02 · MSK · MSK

Serious
Species
Cat
Breed
Domestic Shorthair
Size / weight
10-24 lb (6.3 Kilogram)
Age
4-7 years (6 Year)
Sex
Male Neutered
Region
USA
Reactions
DeathDullNot himself/herselfHead pressingHypotensionUnresponsive to stimuli
Body systems
Other
Outcomes
Died

USA-USFDACVM-2026-US-003405

Received 2026-01-16 · MSK · MSK

Non-serious
Species
Cat
Breed
Domestic Shorthair
Size / weight
Under 10 lb (4.39 Kilogram)
Age
4-7 years (4 Year)
Sex
Female Neutered
Region
USA
Reactions
Balance problemPlantigrade postureLimpingWobblinessMonocytosisGait abnormality
Body systems
Other
Outcomes
Outcome Unknown

USA-USFDACVM-2026-US-001079

Received 2026-01-16 · MSK · MSK

Serious
Species
Cat
Breed
Domestic Shorthair
Size / weight
Under 10 lb (4.395 Kilogram)
Age
4-7 years (4 Year)
Sex
Female Unknown
Region
USA
Reactions
LimpingWobblinessMonocytosisLow creatinineSedationUnkempt hair coatGreasy skinPlantigrade postureMuscle atrophy (see also Muscle wasting)Medication error NOS
Body systems
Other
Outcomes
Ongoing

USA-USFDACVM-2025-US-075379

Received 2025-12-23 · MSK · MSK

Serious
Species
Cat
Breed
Domestic Shorthair
Size / weight
10-24 lb (8.618 Kilogram)
Age
4-7 years (7 Year)
Sex
Male Neutered
Region
USA
Reactions
Injection site hair lossReddening of the skinWeight lossSkin lesion NOSWoundAbnormal cytologyDiscomfort NOSSkin necrosisItchingFacial swelling (see also Skin)Facial rash (For urticaria see Immune SOC)
Body systems
Skin & allergyOther
Outcomes
Ongoing

USA-USFDACVM-2025-US-075148

Received 2025-12-19 · MSK · MSK

Serious
Species
Dog
Breed
['Great Pyrenees', 'Retriever - Labrador']
Size / weight
50-99 lb (31.661 Kilogram)
Sex
Female Neutered
Region
USA
Reactions
Emesis (multiple)
Body systems
Digestive
Outcomes
Ongoing

USA-USFDACVM-2025-US-074361

Received 2025-12-18 · MSK · MSK

Serious
Species
Dog
Breed
['Terrier - Jack Russell', 'Terrier - Bull - American Pit']
Size / weight
25-49 lb (17.236 Kilogram)
Age
1-3 years (1 Year)
Sex
Female Unknown
Region
USA
Reactions
Emesis (multiple)Hives (see also Skin)Reddening of the skinSkin irritationUrine leakageHypersensitivity reaction
Body systems
DigestiveSkin & allergyOther
Outcomes
Ongoing

USA-USFDACVM-2025-US-074431

Received 2025-12-16 · MSK · MSK

Serious
Species
Dog
Breed
['Retriever - Golden', 'Poodle - Standard']
Size / weight
50-99 lb (43.273 Kilogram)
Age
4-7 years (7 Year)
Sex
Male Neutered
Region
USA
Reactions
ThrombocytopeniaBlood loss NOSSkin petechiaeDeath
Body systems
Other
Outcomes
Died

USA-USFDACVM-2025-US-074416

Received 2025-12-16 · MSK · MSK

Non-serious
Species
Dog
Breed
Terrier - Bull - American Pit
Size / weight
50-99 lb (33.339 Kilogram)
Age
1-3 years (1 Year)
Sex
Male Neutered
Region
USA
Reactions
Aggression
Body systems
Behavior
Outcomes
Recovered/Normal

USA-USFDACVM-2025-US-074249

Received 2025-12-16 · MSK · MSK

Non-serious
Species
Dog
Breed
Terrier - Boston
Size / weight
25-49 lb (17.83 Kilogram)
Age
8+ years (9.75 Year)
Sex
Male Neutered
Region
USA
Reactions
ProteinuriaHypoalbuminaemia
Body systems
Other
Outcomes
Ongoing

USA-USFDACVM-2025-US-074064

Received 2025-12-15 · MSK · MSK

Serious
Species
Dog
Breed
['Bichon Frise', 'Chihuahua']
Size / weight
Under 10 lb (3.493 Kilogram)
Age
8+ years (15 Year)
Sex
Female Unknown
Region
USA
Reactions
Seizure NOSAtaxiaUrinary incontinence
Body systems
NeurologicOther
Outcomes
Ongoing

USA-USFDACVM-2025-US-074693

Received 2025-12-12 · MSK · MSK

Serious
Species
Dog
Breed
Shih Tzu
Size / weight
10-24 lb (6.53 Kilogram)
Age
8+ years (11.68 Year)
Sex
Female Neutered
Region
USA
Reactions
Not eatingPeriorbital oedemaFeverLocal swelling (not application site)Nasal dischargeStridor (Upper respiratory; for lower respiratory see also Bronchial rale)Face and neck swelling (see also Skin)SneezingRespiratory tract disorder NOSBiting -aggression (see also Skin and appendages disorders)
Body systems
OtherSkin & allergyBehavior
Outcomes
Ongoing

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-072505

Received 2025-12-11 · MSK · MSK

Serious
Species
Dog
Breed
Terrier - Bull - Staffordshire
Size / weight
50-99 lb (30.935 Kilogram)
Age
4-7 years (4 Year)
Sex
Female Neutered
Region
USA
Reactions
EmesisRegurgitationNauseaGastric distensionMedication error NOSAbnormal radiograph finding
Body systems
DigestiveOther
Outcomes
Ongoing

USA-USFDACVM-2025-US-072294

Received 2025-12-10 · MSK · MSK

Non-serious
Species
Dog
Breed
['Retriever - Golden', 'Dog (unknown)']
Size / weight
50-99 lb (27.48 Kilogram)
Age
1-3 years (2.66 Year)
Sex
Male Neutered
Region
USA
Reactions
Hives (see also Skin)Local erythema
Body systems
Skin & allergyOther
Outcomes
Ongoing

USA-USFDACVM-2025-US-073513

Received 2025-12-09 · MSK · MSK

Non-serious
Species
Dog
Breed
['Pointing Dog - Hungarian Short-haired (Vizsla)', 'Retriever - Labrador']
Size / weight
50-99 lb (40.415 Kilogram)
Age
8+ years (8 Year)
Sex
Male Neutered
Region
USA
Reactions
Application site scarInjection site alopeciaInjection site reaction NOSInjection site noduleMast cell tumourLack of efficacy (neoplasia, relapse)
Body systems
OtherSkin & allergyEffectiveness
Outcomes
Outcome Unknown

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-070899

Received 2025-11-20 · MSK · MSK

Serious
Species
Cat
Breed
Domestic Shorthair
Size / weight
10-24 lb (6.713 Kilogram)
Age
8+ years (10.4 Year)
Sex
Female Neutered
Region
USA
Reactions
Dry mucous membraneNot eatingLethargy (see also Central nervous system depression in Neurological)Fever
Body systems
OtherNeurologic
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

USA-USFDACVM-2025-US-067552

Received 2025-11-13 · MSK · MSK

Serious
Species
Dog
Breed
Shepherd Dog - German
Size / weight
50-99 lb (40.37 Kilogram)
Age
8+ years (9 Year)
Sex
Male Neutered
Region
USA
Reactions
Injection site painNot himself/herselfVomitingWobblinessUnexplained death
Body systems
OtherDigestive
Outcomes
Died

USA-USFDACVM-2025-US-065982

Received 2025-11-03 · MSK · MSK

Serious
Species
Dog
Breed
Dachshund (unspecified)
Size / weight
10-24 lb (9.344 Kilogram)
Age
8+ years (14 Year)
Sex
Male Neutered
Region
USA
Reactions
Lethargy (see also Central nervous system depression in Neurological)AnorexiaPale mucous membraneDecreased haematocritThrombocytopeniaImmune mediated haemolytic anaemiaHyperthermiaHeavy breathingFluid in abdomen NOSWeight lossIntentional misuse
Body systems
NeurologicDigestiveOther
Outcomes
Ongoing

USA-USFDACVM-2025-US-065568

Received 2025-10-27 · MSK · MSK

Non-serious
Species
Cat
Breed
Domestic Shorthair
Size / weight
Under 10 lb (3.5 Kilogram)
Age
8+ years (15.4 Year)
Sex
Male Neutered
Region
USA
Reactions
Pica NOSNasal bleedingNeutrophiliaLymphopeniaStraining to defecateDecreased appetite
Body systems
OtherDigestive
Outcomes
Ongoing

USA-USFDACVM-2025-US-062481

Received 2025-10-21 · MSK · MSK

Serious
Species
Cat
Breed
Domestic Longhair
Sex
Male Unknown
Region
USA
Reactions
Lateral recumbencyDilated pupilsWeaknessHypoglycaemia
Body systems
Other
Outcomes
Outcome Unknown

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

Tracked signals
32
Reported cases
32
Serious reports
29
Species represented
2
Grouped by Body System
Digestive (3) · Loss of appetite, Bloody diarrhoea, Blood in vomit Skin & allergy (1) · Hair loss Neurologic (2) · Unsteady walking (ataxia), Circling - neurological disorder Behavior (3) · Biting -aggression, Behavioral disorder (unspecified), Aggression Other (23) · Cutaneous emphysema, Crust, Confusion
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 Dog 1
Other 1 Dog 1
Other 1 Dog 1
Neurologic 1 Dog 1

Species coverage: Dog (20) Cat (12)

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 Dog Serious - 1
Other Dog Serious - 1
Other Dog Serious - 1
Neurologic Dog Serious - 1
Other Cat Serious - 1
Other Dog Serious - 1
Other Dog Serious - 1
Digestive Dog Serious - 1
Other Dog Serious - 1
Digestive Cat Serious - 1
Behavior Dog Serious - 1
Behavior Cat Non-serious - 1
Other Dog Serious - 1
Other Cat Serious - 1
Other Dog Serious - 1
Other Cat Serious - 1
Other Cat Serious - 1
Other Dog Non-serious - 1
Other Dog Serious - 1
Other Cat Serious - 1
Other Dog Serious - 1
Behavior Dog Non-serious - 1
Other Cat Serious - 1
Other Cat Serious - 1
Other Dog Serious - 1
Other Cat Serious - 1
Other Cat Serious - 1
Other Dog 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.

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

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

Calmatrol SPL

SPL · Structured Product Label

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

Calmatrol SPL

SPL · Structured Product Label

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

Diphenhydramine HCL SPL

SPL · Structured Product Label

FDA Structured Product Label XML for Diphenhydramine HCL. Use the source link for the full official labeling record.
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 Jul 22, 2026, 7:08 PM UTC
    The reference fact projection used for browse cards and quick facts.
  • openFDA reaction terms: Source FDA openFDA | Refreshed Aug 6, 2026, 7:52 PM UTC
  • openFDA case summaries: Source FDA openFDA | Refreshed Aug 6, 2026, 7:52 PM 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 113 Cat 97 View
Case summaries: 39 (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) Cutaneous emphysema (1) Crust (1) Confusion (1) Circulatory collapse (1) Circling - neurological disorder (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, 2026-07-22)
  • contraindications: Use caution with glaucoma, urinary retention, or certain cardiac conditions. (Clinical, 2026-07-22)
  • contraindications: Use caution with glaucoma, urinary retention, or certain cardiac conditions. (Clinical, 2026-07-22)
  • contraindications: Use caution with glaucoma, urinary retention, or certain cardiac conditions. (Clinical, 2026-07-20)
  • contraindications: Use caution with glaucoma, urinary retention, or certain cardiac conditions. (Clinical, 2026-07-19)
  • contraindications: Use caution with glaucoma, urinary retention, or certain cardiac conditions. (Clinical, 2026-07-16)
  • contraindications: Use caution with glaucoma, urinary retention, or certain cardiac conditions. (Clinical, 2026-07-16)
  • contraindications: Use caution with glaucoma, urinary retention, or certain cardiac conditions. (Clinical, 2026-07-13)
  • contraindications: Use caution with glaucoma, urinary retention, or certain cardiac conditions. (Clinical, 2026-07-12)
  • contraindications: Use caution with glaucoma, urinary retention, or certain cardiac conditions. (Clinical, 2026-07-11)
  • contraindications: Use caution with glaucoma, urinary retention, or certain cardiac conditions. (Clinical, 2026-07-11)
  • contraindications: Use caution with glaucoma, urinary retention, or certain cardiac conditions. (Clinical, 2026-07-11)
  • contraindications: Use caution with glaucoma, urinary retention, or certain cardiac conditions. (Clinical, 2026-07-10)
  • contraindications: Use caution with glaucoma, urinary retention, or certain cardiac conditions. (Clinical, 2026-07-07)
  • contraindications: Use caution with glaucoma, urinary retention, or certain cardiac conditions. (Clinical, 2026-07-06)
  • contraindications: Use caution with glaucoma, urinary retention, or certain cardiac conditions. (Clinical, 2026-07-06)
  • contraindications: Use caution with glaucoma, urinary retention, or certain cardiac conditions. (Clinical, 2026-07-03)
  • contraindications: Use caution with glaucoma, urinary retention, or certain cardiac conditions. (Clinical, 2026-07-03)
  • contraindications: Use caution with glaucoma, urinary retention, or certain cardiac conditions. (Clinical, 2026-07-02)
  • contraindications: Use caution with glaucoma, urinary retention, or certain cardiac conditions. (Clinical, 2026-07-01)
Recent Revisions
  • side_effects updated 2026-07-22 19:08 by etl_backfill • Backfilled from existing medication fields
  • contraindications updated 2026-07-22 19:08 by etl_backfill • Backfilled from existing medication fields
  • usage updated 2026-07-22 19:08 by etl_backfill • Backfilled from existing medication fields
  • side_effects updated 2026-07-22 18:40 by etl_backfill • Backfilled from existing medication fields
  • contraindications updated 2026-07-22 18:40 by etl_backfill • Backfilled from existing medication fields
  • usage updated 2026-07-22 18:40 by etl_backfill • Backfilled from existing medication fields
  • side_effects updated 2026-07-22 08:29 by etl_backfill • Backfilled from existing medication fields
  • contraindications updated 2026-07-22 08:29 by etl_backfill • Backfilled from existing medication fields
  • usage updated 2026-07-22 08:29 by etl_backfill • Backfilled from existing medication fields
  • side_effects updated 2026-07-20 10:05 by etl_backfill • Backfilled from existing medication fields
  • contraindications updated 2026-07-20 10:05 by etl_backfill • Backfilled from existing medication fields
  • usage updated 2026-07-20 10:05 by etl_backfill • Backfilled from existing medication fields
  • side_effects updated 2026-07-19 13:48 by etl_backfill • Backfilled from existing medication fields
  • contraindications updated 2026-07-19 13:48 by etl_backfill • Backfilled from existing medication fields
  • usage updated 2026-07-19 13:48 by etl_backfill • Backfilled from existing medication fields
  • side_effects updated 2026-07-16 16:34 by etl_backfill • Backfilled from existing medication fields
  • contraindications updated 2026-07-16 16:34 by etl_backfill • Backfilled from existing medication fields
  • usage updated 2026-07-16 16:34 by etl_backfill • Backfilled from existing medication fields
  • side_effects updated 2026-07-16 15:43 by etl_backfill • Backfilled from existing medication fields
  • contraindications updated 2026-07-16 15:43 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 Bloody diarrhoea (1) • Dog 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 Circling - neurological disorder (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
Cutaneous emphysema (1) • Cat Crust (1) • Dog Confusion (1) • Dog Circulatory collapse (1) • Dog Cardiac disorder NOS (1) • Cat
Show more (18)
Bumps on skin (1) • Dog Breathing difficulty (1) • Dog Blood loss NOS (1) • Dog Balance problem (1) • Dog Azotaemia (1) • Cat Autoimmune disorder NOS (1) • Dog Aspiration pneumonia (1) • Cat Ascites (1) • Cat Application site scar (1) • Dog Anaphylaxis (1) • Dog Anaemia NOS (1) • Cat Agitation (1) • Dog Acute renal failure (1) • Cat Abnormal ultrasound finding (1) • Cat Abnormal radiograph finding (1) • Dog Abnormal histology NOS (1) • Cat Abnormal cytology (1) • Cat Abdominal pain (1) • Dog

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.

Dog, Terrier - Jack Russell, Male, 5 year, 6.409 kilogram • Drug: MSK, Unassigned, Unknown • Reactions: Anaphylaxis, Lateral recumbency, Tachypnoea, Cyanotic mucous membranes • Outcome: Recovered/Normal

  • Report ID: USA-USFDACVM-2026-US-014459
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Male
  • Age: 5.00 Year
  • Weight: 6.409 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Unknown
  • Form: Unassigned
Reactions Reported:
Anaphylaxis Lateral recumbency Tachypnoea Cyanotic mucous membranes
Outcomes: Recovered/Normal

Dog, Shih Tzu, Female, 16 week, 2.49 kilogram • Drug: MSK, Parenteral • Reactions: Facial swelling (possible allergy), Vomiting • Outcome: Outcome Unknown

  • Report ID: USA-USFDACVM-2026-US-014246
  • Serious AE: No
  • Treated For AE: No
  • Sex: Female
  • Age: 16.00 Week
  • Weight: 2.490 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Parenteral
Reactions Reported:
Facial swelling (possible allergy) Vomiting
Outcomes: Outcome Unknown

Dog, Terrier - Bull - Staffordshire, Female, 2 year, 33.611 kilogram • Drug: MSK, Injection, solution, Unknown • Reactions: Facial swelling (possible allergy), Hypersensitivity reaction, Vomiting, Bloody diarrhoea, Unsteady walking (ataxia)… • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2026-US-013479
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Female
  • Age: 2.00 Year
  • Weight: 33.611 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Unknown
  • Form: Injection, solution
Reactions Reported:
Facial swelling (possible allergy) Hypersensitivity reaction Vomiting Bloody diarrhoea Unsteady walking (ataxia) Elevated total bilirubin Elevated alanine aminotransferase Elevated blood urea nitrogen Tiredness (lethargy) Intentional misuse
Outcomes: Ongoing

Dog, Crossbred Canine/dog, Female, 1 year, 14.969 kilogram • Drug: MSK, Injection, solution, Unknown • Reactions: Vocalisation, Restlessness, Intentional misuse • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2026-US-012798
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Female
  • Age: 1.00 Year
  • Weight: 14.969 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Unknown
  • Form: Injection, solution
Reactions Reported:
Vocalisation Restlessness Intentional misuse
Outcomes: Ongoing

Dog, Crossbred Canine/dog, Male, 7 year, 37.648 kilogram • Drug: MSK, Injection, Unknown • Reactions: Regurgitation, Malaise, Wobbliness, Balance problem, Weakness… • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2026-US-014559
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Male
  • Age: 7.00 Year
  • Weight: 37.648 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Unknown
  • Form: Injection
Reactions Reported:
Regurgitation Malaise Wobbliness Balance problem Weakness Confusion Circling - neurological disorder Vomiting Decreased appetite Decreased bowel movements Leukocytosis NOS Neutrophilia Monocytosis Eosinopenia Hypoproteinaemia Reduced globulins Elevated alanine aminotransferase Elevated serum alkaline phosphatase
Outcomes: Ongoing

Dog, Great Pyrenees, Male, 13 year, 40.37 kilogram • Drug: MSK, Unassigned, Oral • Reactions: Vestibular disorder NOS, Unsteady walking (ataxia), Nystagmus, Tympanic rupture • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2026-US-012963
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Male
  • Age: 13.00 Year
  • Weight: 40.370 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Oral
  • Form: Unassigned
Reactions Reported:
Vestibular disorder NOS Unsteady walking (ataxia) Nystagmus Tympanic rupture
Outcomes: Ongoing

Dog, Dalmatian, Male, 10 year, 36.741 kilogram • Drug: MSK, Unassigned, Unknown • Reactions: Agitation, Drooling, Febrile, Panting, Anaphylaxis… • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2026-US-012695
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Male
  • Age: 10.00 Year
  • Weight: 36.741 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Unknown
  • Form: Unassigned
Reactions Reported:
Agitation Drooling Febrile Panting Anaphylaxis Unwell Decreased appetite Urinary incontinence Vomiting Diarrhea Leukocytosis NOS Neutrophilia Lymphocytosis Monocytosis Elevated globulins Elevated serum alkaline phosphatase Anaemia NOS Elevated alanine aminotransferase Elevated C-reactive protein Aggression Urolithiasis Autoimmune disorder NOS Thrombocytopenia
Outcomes: Ongoing

Cat, Domestic Shorthair, Female, 1.5 year, 4.377 kilogram • Drug: MSK, Unassigned, Unknown • Reactions: Vomiting, Localised pain NOS, Limb non-weight bearing, Tiredness (lethargy), Not eating… • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2026-US-011895
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Female
  • Age: 1.50 Year
  • Weight: 4.377 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Unknown
  • Form: Unassigned
Reactions Reported:
Vomiting Localised pain NOS Limb non-weight bearing Tiredness (lethargy) Not eating Head tremor Increased respiratory rate Plantigrade posture Limb weakness Proprioception deficit Cutaneous emphysema Abnormal radiograph finding Knuckling
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.

Share Your Thoughts

Let others know your experience or advice regarding this medication.

This medication has not been reviewed by a veterinarian yet.