fda-cvm foia response 2017-963 february 8,...

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FDA-CVM FOIA Response 2017-963 February 8, 2017

This serves as the response to your Freedom of Information Act (FOIA) request for records regarding

adverse event reports received for afoxolaner, fluralaner, and sarolaner.

A search of CVM’s Adverse Drug Event (ADE) database was performed on 2/8/2017. The search

parameters were:

Active ingredient(s): afoxolaner, fluralaner and sarolaner

Reports received: From 10/16/2016 through 1/26/2017

Case type: Spontaneous ADE report

Species: All

Route of administration: All

For each drug (active ingredient), we have provided the ‘CVM ADE Comprehensive Clinical Detail Report

Listing’, which is a cumulative listing of adverse experiences in reports submitted to CVM.

General Information about CVM’s ADE Database

The primary purpose for maintaining the CVM ADE database is to provide an early warning or signaling system

to CVM for adverse effects not detected during pre-market testing of FDA-approved animal drugs and for

monitoring the performance of drugs not approved for use in animals. Information from these ADE reports is

received and coded in an electronic FDA/CVM ADE database. CVM scientists use the ADE database to make

decisions about product safety which may include changes to the label or other regulatory action. CVM’s ADE

reporting system depends on detection and voluntary reporting of adverse clinical events by veterinarians and

animal owners.

The Center's ADE review process is complex, and for each report takes into consideration

confounding factors such as:

Dosage

Concomitant drug use

The medical and physical condition of animals at the time of treatment

Environmental and management information

Product defects

Extra-label (off label) uses

The specifics of these complex factors cannot be addressed in the CVM ADE Comprehensive Clinical Detail

Report Listing.

How to Use the CVM ADE Comprehensive Clinical Detail Report Listing

Clinical signs reported for an active ingredient are listed in order from most frequently reported to least

frequently reported, grouped by species and route of administration.

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FDA-CVM FOIA Response 2017-963 February 8, 2017

More than one clinical sign may have been reported per ADE case report, so the ‘Number of times

reported’ column is not additive and does not necessarily represent the total number of reports

received. Also, if a manufacturer reports multiple products in a single ADE case report, clinical signs are

associated with each of the manufacturer’s products.

Afoxolaner, fluralaner and sarolaner are approved for oral use in dogs only. For the time period of the ADE

database search (10/16/2016 - 01/26/2017), there were a total of 697 ADE reports received for afoxolaner for

dogs, a total of 1131 ADE reports received for fluralaner for dogs, and a total of 36 ADE reports received for

sarolaner for dogs.

The following table shows the number of reports broken down by all species for which reports have been

received during this time period:

Species # Afoxolaner

reports

# Fluralaner

reports

# Sarolaner

reports

Dog 697 1131 36

Cat 4 94 0

Human (accidental exposures) 2 10 1

Total # ADE reports, all

species

703 1235 37

When reviewing the CVM ADE Comprehensive Clinical Detail Report Listing, the reader should be aware

that:

For any given ADE report, there is no certainty that the reported drug caused the adverse event. The

adverse event may have been related to an underlying disease, using other drugs at the same time, or

other non-drug related causes. The clinical detail listing does not include information about underlying

diseases, other drugs used at the same time, other non-drug related causes, or the final outcome of the

reaction.

The accuracy of information regarding the ADE is dependent on the quality of information received

from the reporting veterinarian or animal owner.

Accumulated ADE reports should not be used to calculate incidence rates or estimates of drug risk,

because there is no accurate way to determine how many animals were actually given the drug, which

is needed as the denominator in calculations of incidence and relative risk.

It is inappropriate to make use of adverse event data to compare the safety of different products.

For example, if a drug is widely used to treat certain conditions, there may be more ADEs for that

drug than another product that is not used as often. This would not mean that the first drug was

more unsafe than the second. The number of reports simply represents the number of ADEs

received for a particular drug and should not be used for any type of comparison purposes.

Underreporting occurs with most adverse event reporting systems. The frequency of reporting for a

given drug product varies over time, and may be greater when the drug is newly marketed, or when

media publicity occurs.

Information on how the drugs were used (for indications on the product label or in an extra label manner)

is not provided in the clinical detail listing.

More information about CVM’s ADE Reporting System can be found on our web site at:

http://www.fda.gov/AnimalVeterinary/SafetyHealth/default.htm.

http://www.fda.gov/AnimalVeterinary/SafetyHealth/default.htm

CVM ADE Comprehensive Clinical Detail Report Listing

Cumulative Date Range : 16-Oct-2016 -thru- 26-Jan-2017

Included 1932a cases = : True

Included Medicated Feed cases = : False

DRUG: FLURALANER

Route of Administration: Species:

ORAL

Cat

Sign : Number of Times Reported :

GAGGING 1

HYPERSALIVATION 1

INEFFECTIVE, DEMODEX MITES 1

MEDICATION ERROR 1


TOPICAL

Cat


LETHARGY 12

EMESIS (MULTIPLE) 8

ANOREXIA 7

APPLICATION SITE GREASY FUR 7

DIARRHOEA 6

APPLICATION SITE HAIR CHANGE 5

APPLICATION SITE HAIR LOSS 5

BEHAVIOURAL DISORDER NOS 5

VOMITING 5

ATAXIA 4

DECREASED APPETITE 4

HYPERSALIVATION 4

PANTING 4

FOAMING AT THE MOUTH 3

Report Printed on 08-Feb-2017 at 12:14:28PM

Report: d:\assured\crystal\CVM ADE Comprehensive Clinical Detail.rpt

Page 1 of 24

Report Version: 1.37

DRUG: FLURALANER


TOPICAL

Cat


HYPERACTIVITY 3

INEFFECTIVE, FLEAS 3

PRURITUS 3

AGITATION 2

ALOPECIA 2

APPLICATION SITE IRRITATION 2

COUGH 2

DEATH BY EUTHANASIA 2

DEHYDRATION 2

FALLING 2

HIDING 2

MALODOUR 2

TACHYCARDIA 2

TACHYPNOEA 2

TWITCHING 2

VOCALISATION 2

ABNORMAL BREATHING 1

ABNORMAL PUPIL LIGHT REFLEX 1

ABNORMAL TEST RESULT 1

AGGRESSION 1

ANAEMIA NOS 1

ANISOCORIA 1

ANTERIOR UVEITIS 1

APPLICATION SITE ALOPECIA 1

APPLICATION SITE ITCHING 1

APPLICATION SITE PARAESTHESIA 1



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DRUG: FLURALANER


TOPICAL

Cat


APPLICATION SITE RASH 1

APPLICATION SITE RESIDUE 1

APPLICATION SITE SCAB 1

APPLICATION SITE SKIN DISCOLOURATION 1

APPLICATION SITE THICKENING 1

BLOOD IN VOMIT 1

BUMPING INTO WALLS 1

DECREASED DRINKING 1

DEPRESSION 1

DROOLING 1

ELECTROLYTE DISORDER 1

ELEVATED LIVER ENZYMES 1

ELEVATED SAP 1

EMESIS 1

EXCORIATION 1

EYE DISORDER NOS 1

FACIAL SWELLING 1

FEVER 1

GRANULOMA 1

GREASY SKIN 1

HAEMOLYTIC ANAEMIA 1

HAIR LOSS NOS 1

HEAD BOBBING 1

HEAD SHAKE - BEHAVIOURAL DISORDER 1

HYPERAESTHESIA 1

HYPERPHOSPHATAEMIA 1



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DRUG: FLURALANER


TOPICAL

Cat


HYPERTHERMIA 1

HYPOGLYCAEMIA 1

IMMUNE MEDIATED HAEMOLYTIC ANAEMIA 1

IMPAIRED VISION 1

INAPPETENCE 1

INAPPROPRIATE DEFECATION 1

INAPPROPRIATE URINATION 1

INEFFECTIVE, DEMODEX MITES 1

IRIS DISORDER 1

ITCHING 1

KERATITIS 1

LABOURED BREATHING 1

LICKING 1

LIMB WEAKNESS 1

LUMP 1

MILIARY DERMATITIS 1

MIOSIS 1

MUSCULOSKELETAL DISORDER NOS 1

MYDRIASIS 1

OPEN MOUTH BREATHING 1

POLYDIPSIA 1

POLYPHAGIA 1

PR-SKIN, LESION(S) 1

RED EYE 1

REDDENING OF THE SKIN 1

SCRATCHING 1



Page 4 of 24


DRUG: FLURALANER


TOPICAL

Cat


SEIZURE NOS 1

SKIN SWELLING 1

SQUINTING 1

STRAINING TO DEFECATE 1

ULCERATION NOS 1

UNRESPONSIVE TO STIMULI 1

WALKING DIFFICULTY 1

WEIGHT LOSS 1


UNKNOWN

Cat


SEIZURE NOS 1


ORAL

Dog


VOMITING 469

EMESIS (MULTIPLE) 131

LETHARGY 129

LACK OF EFFICACY (ECTOPARASITES) 114

DIARRHOEA 107

SEIZURE NOS 43

ANOREXIA 42

PRURITUS 30

WEIGHT LOSS 28

DECREASED APPETITE 27

BLOODY DIARRHOEA 26




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DRUG: FLURALANER


ORAL

Dog


ABNORMAL TEST RESULT 22

BEHAVIOURAL DISORDER NOS 22

DEATH 21

POLYDIPSIA 21

ABNORMAL RADIOGRAPH FINDING 18

ELEVATED SAP 18

LOOSE STOOL 18

FEVER 16

HIVES 16

NOT EATING 16

ELEVATED ALT 15

INAPPETENCE 15

POLYURIA 15

SCRATCHING 14

DEHYDRATION 12

ABNORMAL ULTRASOUND FINDING 11

LEUCOCYTOSIS 11

SHAKING 11

DROOLING 10

PANTING 10

ELEVATED CREATININE 9

HYPERPHOSPHATAEMIA 9

ITCHING 9

DECREASED DRINKING 8

ELEVATED BUN 8

ELEVATED TOTAL BILIRUBIN 8



Page 6 of 24


DRUG: FLURALANER


ORAL

Dog


EMESIS 8

GENERAL HAIR LOSS 8

INAPPROPRIATE URINATION 8

VOCALISATION 8

ANAEMIA NOS 7

ERYTHEMA 7

FACIAL SWELLING 7

FLATULENCE 7

HYPOALBUMINAEMIA 7

LAMENESS 7

LICKING 7

PANCREATITIS 7

TREMOR 7

AGGRESSION 6

BLOOD IN FAECES 6

ELEVATED AMYLASE 6

ELEVATED GAMMA-GLUTAMYL TRANSFERASE (GGT) 6

NEUTROPHILIA 6

RENAL FAILURE 6

RESTLESSNESS 6

RETCHING 6

WALKING DIFFICULTY 6

ALOPECIA 5

ANXIETY 5

ATAXIA 5

CRUST 5



Page 7 of 24


DRUG: FLURALANER


ORAL

Dog


DECREASED PACKED CELL VOLUME (PCV) 5

DEPRESSION 5

DERMATITIS 5

ELEVATED LIPASE 5

ERYTHEMATOUS RASH 5

FREQUENT URINATION 5

GENERALISED ITCHING 5

HYPERACTIVITY 5

HYPERGLYCAEMIA 5

HYPERSALIVATION 5

INTESTINAL DISORDER NOS 5

MALAISE 5

MEDICATION ERROR 5

PYODERMA 5

SKIN SCAB 5

THROMBOCYTOPENIA 5

TREMBLING 5

TWITCHING 5

ABDOMINAL PAIN 4

ABNORMAL BREATHING 4

ADIPSIA 4

BLINDNESS 4

COUGH 4

DECREASED ACTIVITY 4

DISORIENTATION 4

DISTENSION OF ABDOMEN 4



Page 8 of 24


DRUG: FLURALANER


ORAL

Dog


DRY MUCOUS MEMBRANE 4

EXCORIATION 4

GLAZED EYE 4

HAEMATURIA 4

HOT SPOT (PYOTRAUMATIC DERMATITIS) 4

HYPERKALEMIC CONDITION 4

HYPONATREMIA 4

LACK OF EFFICACY 4

LATERAL RECUMBENCY 4

LOW PLATELET COUNT 4

MUSCULOSKELETAL DISORDER NOS 4

NAUSEA 4

OCULAR DISCHARGE 4

PALE MUCOUS MEMBRANE 4

PRODUCT PROBLEM 4


RELUCTANT TO MOVE 4

SKIN IRRITATION 4

THROMBOCYTOSIS 4

URINARY TRACT INFECTION 4

ABDOMINAL MASS 3

ARTHRITIS 3

ASCITES 3

BLOOD IN VOMIT 3

CONJUNCTIVITIS 3

DECREASED NUMBER OF SPERMATOZOA 3



Page 9 of 24


DRUG: FLURALANER


ORAL

Dog


DISCOMFORT NOS 3

DRY SKIN 3

ELEVATED LIVER ENZYMES 3

EOSINOPHILIA 3

FACIAL OEDEMA 3

GAGGING 3

HEAD TREMOR 3

HYPOKALEAEMIA 3

HYPOPROTEINAEMIA 3

ICTERUS 3

INAPPROPRIATE DEFECATION 3

ITCHY SKIN 3

LIMB WEAKNESS 3

LIMPING 3

LOCALISED RASH 3

MENTAL IMPAIRMENT NOS 3

MONOCYTOSIS 3

NASAL DISCHARGE 3

NYSTAGMUS 3

OTITIS EXTERNA 3

PAIN NOS 3

PAPULE 3

PLEURAL EFFUSION 3

PROTEINURIA 3

PUSTULES 3

RASH 3



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DRUG: FLURALANER


ORAL

Dog


RUBBING 3

SMELLY BREATH 3

STAR-GAZING 3

TOOTH DISORDER 3

UNCLASSIFIABLE ADVERSE EVENT 3

WEAKNESS 3

ABDOMINAL CAVITY DISORDER NOS 2

ABNORMAL NECROPSY FINDING 2

ABNORMAL PUPIL LIGHT REFLEX 2

ABNORMAL STOOL COLOURATION 2

ADDISON'S DISEASE 2

ADRENAL GLAND DISORDER NOS 2

AGITATION 2

APPETITE LOSS 2

BILIRUBINURIA 2

BLISTERING 2

BLOTCHY RASH 2

BREATHING DIFFICULTY 2

COLLAPSE 2

CRYING 2

DECREASED BOWEL MOVEMENTS 2

DECREASED CHOLESTEROL (TOTAL) 2

DECREASED URINE CONCENTRATION 2

DIABETES MELLITUS 2

DILATED PUPILS 2

ELEVATED BILE ACIDS 2



Page 11 of 24


DRUG: FLURALANER


ORAL

Dog


ELEVATED CREATININE-KINASE (CK) 2

ENLARGED LYMPH NODE 2

EPIPHORA 2

EXCESSIVE THIRST 2

EYE DISORDER NOS 2

FLAKING SKIN 2

GAIT ABNORMALITY 2

GASTROENTERITIS 2

GENERAL ILLNESS 2

GLUCOSURIA 2

HAEMATOCHEZIA 2

HEAD TILT 2

HEART MURMUR 2

HIDING 2

HYPERCALCAEMIA 2

HYPOGLYCAEMIA 2

HYPOSTHENURIA 2

IMMUNE MEDIATED HAEMOLYTIC ANAEMIA 2

INCOORDINATION 2

INCREASED HEART RATE 2

INEFFECTIVE, TICKS 2

INJECTION SITE PAIN 2

LABOURED BREATHING 2

LIP LICKING 2

LIVER DISORDER NOS 2

LIVER FAILURE 2



Page 12 of 24


DRUG: FLURALANER


ORAL

Dog


LOCALISED ITCHING 2

LOCALISED PAIN NOS 2

MUCOUS STOOL 2

ORAL CAVITY DISORDER NOS 2

PARALYSIS NOS 2

PICA NOS 2

PYURIA 2

RESPIRATORY DISTRESS 2

SHIVERING 2

SKIN ABSCESS 2

SKIN DISORDERS NOS 2

SKIN SORE 2

SKIN ULCER 2

SKIN WARMTH 2

SMALL LIVER 2

STIFFNESS NOS 2

STRAINING TO DEFECATE 2

SUDDEN DEATH 2

SWELLING AROUND EYE 2

SWELLING NOS 2

UNABLE TO STAND 2

UNCOMFORTABLE 2

URINE ABNORMALITIES NOS 2

URINE LEAKAGE 2

WEAKNESS OF LIMB 2

WEIGHT GAIN 2



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DRUG: FLURALANER


ORAL

Dog


WELT 2

ABDOMINAL CAVITY HAEMORRHAGE 1

ABDOMINAL DISCOMFORT 1

ABNORMAL POSTURE NOS 1

ABNORMAL SPERMATOZOA 1

ABNORMAL VISION 1

ALLERGIC PRURITUS 1

ALLERGY NOS 1

ALOPECIA GENERAL 1

ALOPECIA NOS 1

ANAL SAC DISORDER 1

ANGIOEDEMA 1

ANISOCORIA 1

APPETITE DISORDER NOS 1

ARCHED BACK 1

AURAL HAEMATOMA 1

AUTOIMMUNE DISORDER NOS 1

AZOTAEMIA 1

BACTERIAL SKIN INFECTION NOS 1

BALANCE PROBLEM 1

BIRTH DEFECT 1

BITING 1

BLADDER INCONTINENCE 1

BLOATED 1

BLOOD IN URINE 1

BOIL 1



Page 14 of 24


DRUG: FLURALANER


ORAL

Dog


BONE AND JOINT DISORDER NOS 1

BUMPING INTO WALLS 1

BUN LOW, BLD 1

CARDIAC ENLARGEMENT 1

CATARACT 1

CERVICAL SPONDYLOPATHY 1

CHLORIDE LOW, BLOOD 1

CIRCLING 1

COLITIS 1

CONFUSED 1

CONFUSION 1

CONSTIPATION 1

CONVULSION 1

COOMBS TEST POSITIVE 1

CORNEAL ULCER 1

CRANIAL NERVE DISORDER 1

CRYSTALLURIA 1

CUTANEOUS CALCINOSIS 1

CYANOSIS 1

DEAFNESS 1

DECREASED RED BLOOD CELL COUNT 1

DECREASED RESPIRATORY RATE 1

DEPRESSED REFLEXES 1

DERMAL CYST(S) 1

DERMAL MASS 1

DIABETES 1



Page 15 of 24


DRUG: FLURALANER


ORAL

Dog


DIABETIC KETONURIA 1

DIGESTIVE TRACT DISORDER NOS 1

DIGESTIVE TRACT HYPERMOTILITY 1

DISCOLOURED URINE 1

DISORIENTED STATE 1

DRINKING A LOT 1

DRY NOSE 1

DULL 1

DYSPNOEA 1

DYSTOCIA 1

EAR FLAP OEDEMA 1

EAR INFECTION NOS 1

EAR PAIN 1

ELECTROLYTE DISORDER 1

ELEVATED AST 1

ELEVATED CHOLESTEROL (TOTAL) 1

ELEVATED FIBRINOGEN LEVEL 1

ELEVATED GLOBULINS 1

ELEVATED TEMPERATURE 1

ENLARGED KIDNEY(S) 1

ENLARGED LIVER 1

ENTERITIS 1

EPILEPTIC SEIZURE 1

EPISTAXIS 1

EROSION 1

ERYTHEMA MULTIFORME 1



Page 16 of 24


DRUG: FLURALANER


ORAL

Dog


EXCESSIVE LICKING AND/OR GROOMING 1

EXTERNAL EAR DISORDER NOS 1

EYE ITCHING 1

FALLING 1

FLACCID MUSCLES 1

GALL BLADDER & BILE DUCT DISORDER NOS 1

GASTRIC IRRITATION 1

GENERAL PAIN 1

GENERALISED SKIN REACTION 1

HAEMOTHORAX 1

HAIR LOSS NOS 1

HAIR SHEDDING 1

HALITOSIS 1

HEAD BOBBING 1

HEAD SHAKE - BEHAVIOURAL DISORDER 1

HEAD SHAKE - EAR DISORDER 1

HEAD TILT - EAR DISORDER 1

HEPATIC DISORDER NOS 1

HIND LIMB ATAXIA 1

HIND LIMB PARESIS 1

HYPERAEMIC MUCOUS MEMBRANE 1

HYPERAESTHESIA 1

HYPERALBUMINAEMIA 1

HYPERCHLORAEMIA 1

HYPERMETRIA 1

HYPERNATREMIA 1



Page 17 of 24


DRUG: FLURALANER


ORAL

Dog


HYPERPIGMENTATION 1

HYPERSTHENURIA 1

HYPERTENSION 1

HYPOCALCAEMIC CONDITION 1

HYPOKALEMIC CONDITION 1

HYPOPHOSPHATAEMIA 1

HYPOTENSION 1

HYPOTHYROIDISM 1

IDIOPATHIC VESTIBULAR DISEASE 1

IMMUNE MEDIATED THROMBOCYTOPENIA 1

IMPAIRED VISION 1

INCREASED APPETITE 1

INCREASED BORBORYGMUS 1

INCREASED BOWEL MOVEMENTS (FREQUENCY) 1

INCREASED PACKED CELL VOLUME (PCV) 1

INCREASED RESPIRATORY RATE 1

INCREASED SEIZURE FREQUENCY 1

INCREASED SKIN SENSITIVITY 1

INJECTION SITE LUMP 1

INTESTINAL PERFORATION 1

INTRAUTERINE DEATH 1

INVOLUNTARY MOVEMENT 1

JAUNDICE 1

JOINT LIGAMENT DISORDER NOS 1

JOINT PAIN 1

LACK OF RESPONSE TO OWNER 1



Page 18 of 24


DRUG: FLURALANER


ORAL

Dog


LENS DISORDER NOS 1

LEUCOPENIA 1

LEUKAEMIA 1

LIP SMACKING 1

LIPAEMIA 1

LOCAL SWELLING (NOT APPLICATION SITE) 1

LOCALISED HAIR LOSS 1

LOOSE BOWEL 1

LOW VISION 1

LUMBAR PAIN 1

LUMP 1

LUNG TUMOUR 1

LYMPHOCYTOSIS 1

LYMPHOMA 1

MALODOUR 1

METABOLIC BONE DISORDER NOS 1

MISCARRIAGE 1

MOUTH PAIN 1

MOUTH ULCER 1

MUCOSA PETECHIAE 1

MULTI-ORGAN FAILURE NOS 1

MUSCLE TREMOR 1

MUSCULOSKELETAL PAIN 1

MYOCLONIC JERK 1

NASAL CONGESTION 1

NEPHROPATHY 1



Page 19 of 24


DRUG: FLURALANER


ORAL

Dog


NEUROLOGICAL SIGNS NOS 1

NEUROLOGICAL SYMPTOMS NOS 1

NOT DRINKING 1

NT - PROLIFERATIVE GLOMERULONEPHRITIS 1

OEDEMA OF THE EXTREMITIES 1

ORAL BLEEDING 1

ORAL MASS 1

OTHER EAR DISORDER NOS 1

OTITIS NOS 1

PACING 1

PADDLING 1

PAPULAR RASH 1

PEMPHIGUS FOLIACEUS 1

PERINATAL MORTALITY 1

PERITONITIS 1

PILOERECTION 1

POLLAKIURIA 1

POLYCYTHEMIA 1

POOR COAT CONDITION 1

PR-KIDNEY(S), LESION(S) 1

PR-LIVER, LESION(S) 1

PROFUSE BLEEDING 1

PROLONGED ACTIVATED PARTIAL THROMBIN TIME (APTT) 1

PROLONGED ONE STAGE PROTHROMBIN TIME (OSPT) 1

PROPRIOCEPTION DEFICIT 1

PR-PANCREAS, LESION(S) 1



Page 20 of 24


DRUG: FLURALANER


ORAL

Dog


PR-SMALL INTESTINE, LESION(S) 1

PRURITIC RASH 1

PULMONARY DISORDER NOS 1

RED EYE 1

REDUCED LEVEL OF CONSCIOUSNESS 1

RENAL INSUFFICIENCY 1

RETINAL DEGENERATION 1

ROLLING 1

SCROTAL OEDEMA 1

SELF TRAUMA 1

SEPTICAEMIA 1

SHALLOW BREATHING 1

SICK EUTHYROID SYNDROME 1

SKIN DRYNESS 1

SKIN LESION NOS 1

SKIN PETECHIAE 1

SKIN SLOUGH 1

SKIN TUMOUR NOS 1

SLEEPINESS - SYSTEMIC DISORDER 1

SNEEZING 1

SODIUM:POTASSIUM LOW, BLOOD 1

SORE TONGUE 1

SPASM 1

SPLEEN AND RETICULO-ENDOTHELIAL SYSTEM DISORDER NOS 1

SPLEEN HYPERTROPHY 1

SPLENOMEGALY 1



Page 21 of 24


DRUG: FLURALANER


ORAL

Dog


STAGGERING 1

STEATITIS 1

STERILE 1

STIFF GAIT 1

STOMACH PAIN 1

SYSTEMIC DISORDER NOS 1

TACHYCARDIA 1

TENSE ABDOMEN 1

THORACIC CAVITY DISORDER NOS 1

TITER DATA ABNORMAL 1

TONIC-CLONIC SEIZURE 1

UNABLE TO RISE 1

UNSTEADY GAIT 1

URINARY INCONTINENCE 1

URTICARIA 1

URTICARIAL RASH 1

WHEEZING 1


OTHER

Dog


ABDOMINAL MASS 1

ABDOMINAL PAIN 1

ABNORMAL ULTRASOUND FINDING 1

ANOREXIA 1


DIARRHOEA 1



Page 22 of 24


DRUG: FLURALANER


OTHER

Dog


ENLARGED LIVER 1

FLATULENCE 1

LIVER DISORDER NOS 1


TRANSPLACENTAL

Dog


CLEFT PALATE 2

BIRTH DEFECT 1

CONGENITAL NEUROLOGICAL DISORDER NOS 1

DEATH 1


MALFORMATION NOS 1

STILLBIRTH 1


UNKNOWN

Dog


UNCLASSIFIABLE ADVERSE EVENT 1

URINARY TRACT DISORDER NOS 1


ORAL

Human


DIARRHOEA 1

DRY MOUTH 1

INCREASED HEART RATE 1

MALAISE 1


TOPICAL

Human




Page 23 of 24


DRUG: FLURALANER


TOPICAL

Human


APPLICATION SITE SKIN CHANGE NOS 2

APPLICATION SITE REACTION NOS 1

APPLICATION SITE REDDENING 1

APPLICATION SITE TINGLING 1

FACIAL RASH 1

HIVES 1

LOCALISED ITCHING 1

MALAISE 1

PRODUCT PROBLEM 1


SKIN DISORDERS NOS 1

SKIN IRRITATION 1

URTICARIAL ERYTHEMA 1



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