Animal drug adverse event reports

MSK

Human · Reactions: Headache, Accidental exposure

PatientSerious
Treated for ae
false
Unique aer ID number
USA-USFDACVM-2017-US-023442
Original receive date
20170518
Number of animals affected
1
Primary reporter
Patient
Number of animals treated
1
Secondary reporter
Other
Onset date
20170518
Foreign or domestic
Domestic
Report ID
N141277
Type of information
Safety Issue
Serious ae
true
Reaction
  1. Veddra version
    11
    Veddra term code
    1511
    Veddra term name
    Headache
    Number of animals affected
    1
    Accuracy
    Actual
  2. Veddra version
    7
    Veddra term code
    99809
    Veddra term name
    Accidental exposure
    Number of animals affected
    1
    Accuracy
    Actual
Receiver
Organization
Food and Drug Administration Center for Veterinary Medicine
Street address
7500 Standish Place (HFV-210) Room N403
City
Rockville
State
MD
Postal code
20855
Country
USA
Drug
  1. First exposure date
    20170518
    Last exposure date
    20170518
    Administered by
    Patient
    Route
    Oral
    Used according to label
    false
    Previous exposure to drug
    false
    Brand name
    MSK
    Dosage form
    Tablet, chewable
    Atc vet code
    QP53BX03
    Dose
    Numerator
    1
    Numerator unit
    tablet
    Denominator
    1
    Denominator unit
    Unknown
    Off label use
    Species Off-Label , Other off label issue
    Manufacturer
    Name
    MSK
    Registration number
    USA-USFDACVM-N141277
    Active ingredients
    1. Name
      Spinosad
      Dose
      Numerator
      270
      Numerator unit
      Milligram
      Denominator
      1
      Denominator unit
      dose
  2. First exposure date
    20170101
    Administered by
    Patient
    Route
    Oral
    Brand name
    MSK
    Manufacturer
    Name
    MSK
    Active ingredients
    1. Name
      Gabapentin
      Dose
      Numerator
      1
      Numerator unit
      Unknown
      Denominator
      1
      Denominator unit
      Unknown
  3. First exposure date
    20170101
    Administered by
    Patient
    Route
    Oral
    Brand name
    MSK
    Manufacturer
    Name
    MSK
    Active ingredients
    1. Name
      Clonazepam
      Dose
      Numerator
      1
      Numerator unit
      Unknown
      Denominator
      1
      Denominator unit
      Unknown
  4. First exposure date
    20170101
    Administered by
    Patient
    Route
    Oral
    Brand name
    MSK
    Manufacturer
    Name
    MSK
    Active ingredients
    1. Name
      Divalproex Sodium
      Dose
      Numerator
      1
      Numerator unit
      Unknown
      Denominator
      1
      Denominator unit
      Unknown
  5. First exposure date
    20170101
    Administered by
    Patient
    Route
    Oral
    Brand name
    MSK
    Manufacturer
    Name
    MSK
    Active ingredients
    1. Name
      Quetiapine Fumarate
      Dose
      Numerator
      1
      Numerator unit
      Unknown
      Denominator
      1
      Denominator unit
      Unknown
  6. First exposure date
    20170101
    Administered by
    Patient
    Route
    Oral
    Brand name
    MSK
    Manufacturer
    Name
    MSK
    Active ingredients
    1. Name
      Fluoxetine Hcl
      Dose
      Numerator
      1
      Numerator unit
      Unknown
      Denominator
      1
      Denominator unit
      Unknown
  7. First exposure date
    20170101
    Administered by
    Patient
    Route
    Oral
    Brand name
    MSK
    Manufacturer
    Name
    MSK
    Active ingredients
    1. Name
      Topiramate
      Dose
      Numerator
      1
      Numerator unit
      Unknown
      Denominator
      1
      Denominator unit
      Unknown
  8. First exposure date
    20170101
    Administered by
    Patient
    Route
    Oral
    Brand name
    MSK
    Manufacturer
    Name
    MSK
    Active ingredients
    1. Name
      Levothyroxine
      Dose
      Numerator
      1
      Numerator unit
      Unknown
      Denominator
      1
      Denominator unit
      Unknown
  9. First exposure date
    20170101
    Administered by
    Patient
    Route
    Oral
    Brand name
    MSK
    Manufacturer
    Name
    MSK
    Active ingredients
    1. Name
      Naproxen
      Dose
      Numerator
      1
      Numerator unit
      Unknown
      Denominator
      1
      Denominator unit
      Unknown
  10. First exposure date
    20170101
    Administered by
    Patient
    Route
    Oral
    Brand name
    MSK
    Manufacturer
    Name
    MSK
    Active ingredients
    1. Name
      Primidone
      Dose
      Numerator
      1
      Numerator unit
      Unknown
      Denominator
      1
      Denominator unit
      Unknown
  11. First exposure date
    20170101
    Administered by
    Patient
    Route
    Oral
    Brand name
    MSK
    Manufacturer
    Name
    MSK
    Active ingredients
    1. Name
      Multivitamin Supplement
      Dose
      Numerator
      1
      Numerator unit
      Unknown
      Denominator
      1
      Denominator unit
      Unknown
  12. First exposure date
    20170101
    Administered by
    Patient
    Route
    Oral
    Brand name
    MSK
    Manufacturer
    Name
    MSK
    Active ingredients
    1. Name
      Acetaminophen
      Dose
      Numerator
      1
      Numerator unit
      Unknown
      Denominator
      1
      Denominator unit
      Unknown
  13. +1 more not shown
Health assessment prior to exposure
Condition
Fair
Assessed by
Veterinarian
Animal
Species
Human
Gender
Female
Age
Min
52.00
Unit
Year
Qualifier
Measured
Weight
Qualifier
Unknown
Outcome
  1. Medical status
    Recovered/Normal
    Number of animals affected
    1
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How to read this: Each report says someone told FDA an event happened while a product was used. A report does not show the product caused it, and counts rise and fall with how many people report. Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.