Convulsions (1) Disorientation (1) Erythema (1) Frothing at the mouth (1) Lesions (1) Muscle stiffness (1) Scabs (1) Weakness (1) Acetyl glucosamine Equine Number of Reports Probable Possible 1 1 0 Presenting signs (probable and possible) Equine Pyrexia (1) Swelling (local) (1) Agelpristone Canine Number of Reports Probable Possible 5 5 0 Presenting signs (probable and possible) Lack of effect (5) Albendazole Ovine Number of Reports Probable Possible 15 4 11 Presenting signs (probable and possible) Death (15) Lethargy (2) Anorexia (1) Convulsions (1) Disorientation (1) Frothing at the mouth (1) Frothing at the nose (1) Hypersalivation (1) Muscle stiffness (1) Recumbency (1) Weakness (1)
Alpha-cypermethrin Ovine Number of Reports Probable Possible 1 0 1 Presenting signs (probable and possible) Lack of effect (1) Alphaxalone Canine Number of Reports Probable Possible 13 0 13 Presenting signs (probable and possible) Bradycardia (3) Recovery (poor) (3) Apnoea (2) Death (2) Swelling (local) (2) Cardiac arrest (1) Cyanosis (1) Dyspnoea (1) Erythema (1) Injected mucous membranes (1) Low efficacy (1) Oedema (1) Periorbital swelling (1) Recovery (prolonged) (1) Seizure (1) Vomiting (1) Feline Number of Reports Probable Possible 10 1 9 Presenting signs (probable and possible) Respiratory problems (3) Anisocoria (2) Cardiac arrest (2) Death (2) Pulmonary oedema (2) Tremor (2) Apnoea (1) Diarrhoea (1) Hypersalivation (1) Oedema (1) Swelling (local) (1) Vomiting (1) Aluminium hydroxide Aluminium hydroxide is a compound commonly used as an adjuvant in vaccines. It stabilises vaccine proteins, preventing the vaccine from adhering to the glass container. It is also thought to enhance the
Amoxycillin as Amoxycillin trihydrate Canine Number of Reports Probable Possible 5 2 3 Presenting signs (probable and possible) Oedema (3) Injection site reaction (2) Anaphylaxis (1) Hypotension (1) Feline Number of Reports Probable Possible 1 0 1 Presenting signs (probable and possible) Allergy (1) Oedema (1) Amphotericin B Feline Number of Reports Probable Possible 1 0 1 Presenting signs (probable and possible) Anorexia (1) Injection site reaction (1) Lethargy (1) Anaplasma centrale Bovine Number of Reports Probable Possible 1 0 1 Presenting signs (probable and possible) Lack of effect (18) Vaccination reaction (2)
Bordetella bronchiseptica Canine Number of Reports Probable Possible 149 45 104 Presenting signs (probable and possible) Injection site reaction (45) Coughing (30) Sneezing (21) Lethargy (18) Facial oedema (15) Anorexia (11) Nasal discharge (11) Vomiting (11) Pain (5) Respiratory problems (5) Swelling (local) (5) Anaphylactoid reaction (4) Diarrhoea (4) Pneumonia (3) Anaphylaxis (2) Conjunctivitis (2) Ocular discharge (2) Pharyngitis (2) Pruritis (2) Arthropathy (1) Bronchitis (1) Defaecation (1) Epiphora (1) Hepatopathy (1) Inflammation (1) Listless (1) Lump (local) (1) Lymphadenopathy (1) Megaoesophagus (1) Oedema (1) Polyarthritis (1) Pyrexia (1) Shaking (1) Sweating (1) Swollen ears and face (1) Swollen lips and face (1) Tonsillitis (1) Urticaria (1) Weakness (1) Wheals (1) Bordetella bronchiseptica (inactivated cell free extract) Canine Number of Reports Probable Possible 46 5 41 Presenting signs (probable and possible) Injection site reaction (21) Lethargy (14) Pain (9) Vomiting (7) Pyrexia (6) Anorexia (4) Malaise (4) Oedema (3) Pruritis (3) Allergy (2) Anaphylaxis (2) Ataxia (2) Collapse (2) Cyanosis (2) Facial oedema (2) Hypotension (2) Immune-mediated haemolytic anaemia (2) Respiratory problems (2) Urticaria (2) Behavioural change (1)
Coughing (1) Inflammation (1) Lump (local) (1) Site reaction (swelling) (1) Unconscious (1) Vocalisation (1) Bordetella bronchiseptica killed vaccine Canine Number of Reports Probable Possible 59 0 59 Presenting signs (probable and possible) Anaphylactoid reaction (17) Facial oedema (17) Anaphylaxis (7) Vomiting (7) Collapse (6) Pruritis (6) Urticaria (6) Injection site reaction (4) Pale mucous membranes (3) Pyrexia (3) Agitation (2) Bradycardia (2) Erythema (2) Red eyes (2) Swollen lips and face (2) Tachycardia (2) Tachypnoea (2) Ataxia (1) Cyanosis (1) Immune-mediated haemolytic anaemia (1) Lethargy (1) Pyoderma (1) Rash (1) Thrombocytopenia (1) Vocalisation (1) Bovine coronavirus (inactivated) Bovine Number of Reports Probable Possible 2 2 0 Presenting signs (probable and possible) Malaise (2) Milk production decrease (2) Injection site reaction (1) Pyrexia (1) Bovine ephemeral fever virus (BEFV) Bovine Number of Reports Probable Possible 2 0 2 Presenting signs (probable and possible)
Swollen ears and face (3) Agitation (2) Epiphora (2) Erythema (2) Pale mucous membranes (2) Pharyngitis (2) Polyarthritis (2) Red eyes (2) Swollen lips and face (2) Tachycardia (2) Tachypnoea (2) Allergy (1) Behavioural change (1) Bradycardia (1) Bronchitis (1) Cyanosis (1) Death (1) Dyspnoea (1) Haemorrhagic gastroenteritis (1) Hepatopathy (1) Immune-mediated haemolytic anaemia (1) Inflammation (1) Lump (local) (1) Lymphadenopathy (1) Megaoesophagus (1) Oedema (1) Pneumonia (1) Pyoderma (1) Rash (1) Shaking (1) Site reaction (swelling) (1) Thrombocytopenia (1) Tonsillitis (1) Unconscious (1) Canine adenovirus type 2 - live (infectious hepatitis) Canine Number of Reports Probable Possible 33 1 32 Presenting signs (probable and possible) Injection site reaction (20) Lack of effect (4) Malaise (4) Collapse (3) Lethargy (3) Anorexia (2) Cyanosis (2) Hypotension (2) Immune-mediated haemolytic anaemia (2) Anaphylaxis (1) Facial oedema (1) Hypothermia (1) Pale mucous membranes (1) Pruritis (1) Pyrexia (1) Respiratory problems (1) Urticaria (1) Vasculitis (1) Vomiting (1) Canine adenovirus type 2 live (CAV II) Canine Number of Reports Probable Possible 1 1 Presenting signs (probable and possible) Anorexia (1) Lethargy (1) Vomiting (1)
Canine parainfluenza Canine Number of Reports Probable Possible 33 5 28 Presenting signs (probable and possible) Coughing (15) Nasal discharge (9) Sneezing (9) Facial oedema (5) Lethargy (3) Respiratory problems (3) Anorexia (2) Pharyngitis (2) Bronchitis (1) Diarrhoea (1) Epiphora (1) Lymphadenopathy (1) Pneumonia (1) Polyarthritis (1) Pyrexia (1) Swollen ears and face (1) Tonsillitis (1) Urticaria (1) Vomiting (1) Canine parainfluenza virus type 2 Canine Number of Reports Probable Possible 90 4 86 Presenting signs (probable and possible) Lack of effect (24) Facial oedema (22) Anaphylactoid reaction (18) Pruritis (8) Anaphylaxis (7) Vomiting (7) Collapse (6) Injection site reaction (6) Urticaria (5) Pale mucous membranes (3) Pyrexia (3) Agitation (2) Bradycardia (2) Erythema (2) Red eyes (2) Swollen lips and face (2) Tachycardia (2) Tachypnoea (2) Ataxia (1) Cyanosis (1) Immune-mediated haemolytic anaemia (1) Lethargy (1) Pyoderma (1) Rash (1) Thrombocytopenia (1) Vocalisation (1)
Canine parainfluenza virus Canine Number of Reports Probable Possible 126 41 85 Presenting signs (probable and possible) Injection site reaction (45) Lethargy (25) Vomiting (16) Coughing (14) Pain (13) Sneezing (12) Anorexia (11) Facial oedema (7) Swelling (local) (5) Anaphylactoid reaction (4) Pyrexia (4) Anaphylaxis (3) Diarrhoea (3) Ataxia (2) Conjunctivitis (2) Nasal discharge (2) Ocular discharge (2) Oedema (2) Pneumonia (2) Pruritis (2) Respiratory problems (2) Allergy (1) Arthropathy (1) Behavioural change (1) Defaecation (1) Hepatopathy (1) Inflammation (1) Listless (1) Lump (local) (1) Megaoesophagus (1) Shaking (1) Site reaction (swelling) (1) Sweating (1) Swollen lips and face (1) Unconscious (1) Weakness (1) Wheals (1) Canine parainfluenza virus – inactivated Canine Number of Reports Probable Possible 28 2 26 Presenting signs (probable and possible) Injection site reaction (20) Malaise (4) Lethargy (3) Anorexia (2) Collapse (2) Cyanosis (2) Hypotension (2) Immune-mediated haemolytic anaemia (2) Pruritis (2) Anaphylaxis (1) Facial oedema (1) Lump (local) (1) Oedema (1) Pyrexia (1) Respiratory problems (1) Urticaria (1) Vomiting (1)
Shaking (1) Sneezing (1) Thrombocytopenia (1) Canine parvovirus type 2 Canine Number of Reports Probable Possible 24 3 21 Presenting signs (probable and possible) Lethargy (10) Pain (8) Vomiting (8) Lack of effect (7) Pyrexia (4) Anorexia (3) Ataxia (2) Injection site reaction (2) Allergy (1) Anaphylaxis (1) Behavioural change (1) Diarrhoea (1) Facial oedema (1) Haemorrhagic gastroenteritis (1) Hepatopathy (1) Inflammation (1) Oedema (1) Pruritis (1) Site reaction (swelling) (1) Unconscious (1) Canine parvovirus - live Canine Number of Reports Probable Possible 33 1 32 Presenting signs (probable and possible) Injection site reaction (20) Lack of effect (4) Malaise (4) Collapse (3) Lethargy (3) Anorexia (2) Cyanosis (2) Hypotension (2) Immune-mediated haemolytic anaemia (2) Anaphylaxis (1) Facial oedema (1) Hypothermia (1) Pale mucous membranes (1) Pruritis (1) Pyrexia (1) Respiratory problems (1) Urticaria (1) Vasculitis (1) Vomiting (1)
Clomipramine hydrochloride Canine Number of Reports Probable Possible 4 0 4 Presenting signs (probable and possible) Hyperactivity (3) Behavioural change (2) Distress (2) Feline Number of Reports Probable Possible 18 11 7 Presenting signs (probable and possible) Lethargy (12) Urinary retention (11) Stranguria (9) Anorexia (4) Adipsia (2) Vocalisation (2) Vomiting (2) Behavioural change (1) Constipation (1) Dysphonia (1) Incontinence (1) Clostridium chauvoei—Formol culture Bovine Number of Reports Probable Possible 4 2 2 Presenting signs (probable and possible) Allergy (1) Anaphylaxis (1) Death (1) Lump (local) (1) Milk production decrease (1) Oedema (1) Vaginitis (1) Caprine Number of Reports Probable Possible 1 0 1 Presenting signs (probable and possible) Injection site reaction (1) Oedema (1) Pain (1)
Death (1) Lame (1) Shaking (1) Clostridium perfringens type B toxoid Bovine Number of Reports Probable Possible 1 1 0 Presenting signs (probable and possible) Injection site reaction (1) Clostridium perfringens type C toxoid Bovine Number of Reports Probable Possible 3 3 0 Presenting signs (probable and possible) Injection site reaction (2) Malaise (2) Milk production decrease (2) Pyrexia (1) Clostridium perfringens type D toxoid Bovine Number of Reports Probable Possible 7 5 2 Presenting signs (probable and possible) Milk production decrease (3) Injection site reaction (2) Malaise (2) Allergy (1) Anaphylaxis (1) Death (1) Lump (local) (1) Oedema (1) Pyrexia (1) Vaginitis (1) Caprine Number of Reports Probable Possible 3 1 2 Presenting signs (probable and possible)
Presenting signs (probable and possible) Injection site reaction (1) Lack of effect (1) Oedema (1) Pain (1) Ovine Number of Reports Probable Possible 3 3 0 Presenting signs (probable and possible) Injection site reaction (2) Abscess (1) Ataxia (1) Death (1) Shaking (1) Cyclosporin Cyclosporin is a widely used immunosuppressant drug used in the treatment of immune-mediated conditions. The most commonly reported presenting signs are gastrointestinal related, most notably vomiting and diarrhoea. The number of reports associated with Cyclosporin is low when compared with the number of doses sold in 2013 (less than 1 in 10 000 doses) and therefore no regulatory action is required other than continued monitoring for unexpected or severe reactions. Cyclosporin Canine Number of Reports Probable Possible 87 56 31 Presenting signs (probable and possible) Vomiting (55) Diarrhoea (21) Pruritis (16) Lethargy (9) Anorexia (8) Tachypnoea (6) Distress (4) Hyperactivity (4) Dermatitis (3) Tremor (3) Behavioural change (2) Coat colour change (2) Eczema (2) Erythema (2) Hyperkeratosis (2) Injected mucous membranes (2) Neoplasia (2) Red eyes (2) Vocalisation (2) Abdominal pain (1) Agitation (1) Alopecia (1) Cellulitis (1) Collapse (1) Dehydration (1) Diabetes (1) Elevated ALP (1)
Hairy (1) Hepatopathy (1) Lack of effect (1) Leucocytosis (1) Otitis externa (1) Pancreatitis (1) Pigmentation (1) Restless (1) Shaking (1) Tachycardia (1) Cypermethrin Bovine Number of Reports Probable Possible 2 0 2 Presenting signs (probable and possible) Lack of effect (2) Deltamethrin Bovine Number of Reports Probable Possible 1 0 1 Presenting signs (probable and possible) Lack of effect (1) Canine Number of Reports Probable Possible 28 13 15 Presenting signs (probable and possible) Lack of effect (8) Pruritis (7) Dermatitis (6) Lethargy (3) Irritation (skin) (2) Agitation (1) Anorexia (1) Ataxia (1) Dehydration (1) Depression (1) Electrolyte changes (1) Facial oedema (1) Listless (1) Muscle twitching (1) Rash (1) Tremor (1) Vomiting (1)
Diarrhoea (1) Head tilt (1) Irritation (skin) (1) Muscle twitching (1) Pain (1) Welts (1) Wheals (1) Feline Number of Reports Probable Possible 38 19 19 Presenting signs (probable and possible) Alopecia (localised) (22) Scabs (8) Erythema (6) Pruritis (6) Inflammation (4) Lethargy (4) Anorexia (3) Alopecia (2) Panting (2) Vomiting (2) Diarrhoea (1) Head tilt (1) Hypersalivation (1) Lack of effect (1) Lesions (1) Tachycardia (1) Tremor (1) Firocoxib Canine Number of Reports Probable Possible 2 0 2 Presenting signs (probable and possible) Lethargy (1) Pancreatitis (1) Renal failure (1) Fluazuron Bovine Number of Reports Probable Possible 1 0 1 Presenting signs (probable and possible) Lack of effect (1)
Flunixin as Flunixin meglumine Equine Number of Reports Probable Possible 2 0 2 Presenting signs (probable and possible) Ataxia (1) Behavioural change (1) Death (1) Epistaxis (1) Sweating (1) Fluoxetine hydrochloride Canine Number of Reports Probable Possible 7 2 5 Presenting signs (probable and possible) Anorexia (2) Ataxia (2) Behavioural change (2) Elevated ALP (1) Haematology (abnormal) (1) Incoordination (1) Lack of effect (1) Somnolence (1) Tremor (1) Formalin Bovine Number of Reports Probable Possible 1 1 0 Presenting signs (probable and possible) Anorexia (1) Lethargy (1) Gentamicin sulfate Canine Number of Reports Probable Possible 2 1 1
Maropitant as Maropitant citrate Canine Number of Reports Probable Possible 4 0 4 Presenting signs (probable and possible) Injection site reaction (3) Lack of effect (1) Oedema (1) Pyrexia (1) Mavacoxib Canine Number of Reports Probable Possible 20 10 10 Presenting signs (probable and possible) Vomiting (11) Anorexia (4) Hepatopathy (3) Azotaemia (2) Haemorrhagic gastroenteritis (2) Lethargy (2) Renal failure (2) Anaemia (1) Arthropathy (1) Blood in faeces (1) Death (1) Dehydration (1) Diarrhoea (1) Fatigue (1) Gastric dilatation (1) Gastroenteritis (1) Haematemesis (1) Hyperactivity (1) Lack of effect (1) Panting (1) Renal disease (1) Medetomidine hydrochloride Canine Number of Reports Probable Possible 6 0 6 Presenting signs (probable and possible) Bradycardia (3) Anaphylactoid reaction (1) Apnoea (1) Ataxia (1) Death (1) Dyspnoea (1) Head tilt (1) Nystagmus (1) Seizure (1) Shaking (1) Somnolence (1)
Feline Number of Reports Probable Possible 12 8 4 Presenting signs (probable and possible) Vomiting (4) Tremor (3) Ataxia (2) Lethargy (2) Somnolence (2) Alopecia (localised) (1) Blindness (1) Blurred vision (1) Injection site reaction (1) Lack of effect (1) Shaking (1) Monensin as Monensin sodium Bovine Number of Reports Probable Possible 63 18 45 Presenting signs (probable and possible) Regurgitation (31) Lack of effect (22) Choking (4) Death (3) Toxicity (2) Anorexia (1) Coat discoloration (1) Diarrhoea (1) Scouring (1) Weight loss (1) Morantel tartrate Equine Number of Reports Probable Possible 2 1 1 Presenting signs (probable and possible) Anorexia (1) Gingival soreness (1) Lethargy (1) Pawing at ground (1) Shaking (1)
The most commonly reported presenting signs included facial oedema, vomiting and lethargy. The APVMA notes that products containing this active constituent are often used in conjunction with other products (including vaccines) resulting in a higher number of reports. In most cases it is impossible to attribute the cause of an adverse reaction to a single active constituent. Hence a single report may be classified against multiple active constituents that may have a potential relationship to an adverse experience. The number of reports associated with moxidectin microspheres is low when compared with the number of doses sold in 2013 (less than 1 in 10 000 doses) and therefore no regulatory action is required other than continued monitoring for unexpected or severe reactions. Moxidectin microspheres Canine Number of Reports Probable Possible 116 29 87 Presenting signs (probable and possible) Vomiting (35) Facial oedema (27) Lethargy (15) Injection site reaction (14) Anaphylaxis (11) Pruritis (11) Anaphylactoid reaction (10) Oedema (9) Pyrexia (9) Urticaria (9) Anorexia (8) Lump (local) (8) Diarrhoea (7) Pain (6) Pale mucous membranes (5) Allergy (4) Ataxia (4) Collapse (3) Hypersalivation (3) Cyanosis (2) Erythema (2) Hepatopathy (2) Inflammation (2) Tachypnoea (2) Unconscious (2) Abdominal pain (1) Behavioural change (1) Blood in faeces (1) Bradycardia (1) Conjunctivitis (1) Convulsions (1) Defaecation (1) Epiphora (1) Haemorrhage (1) Hypotension (1) Malaise (1) Necrosis (1) Panting (1) Sarcoma (1) Site reaction (swelling) (1) Sweating (1) Swelling (local) (1) Tachycardia (1) Tremor (1) Wheals (1)
Permethrin (25:75:cis:trans) Feline Number of Reports Probable Possible 1 1 0 Presenting signs (probable and possible) Ataxia (1) Muscle twitching (1) Seizure (1) Tremor (1) Permethrin (40:60:cis:trans) Canine Number of Reports Probable Possible 9 1 8 Presenting signs (probable and possible) Lack of effect (6) Hypersalivation (2) Abdominal pain (1) Ataxia (1) Erythema (1) Lethargy (1) Nausea (1) Seizure (1) Shaking (1) Site reaction (1) Tachycardia (1) Tachypnoea (1) Vocalisation (1) Vomiting (1) Phenylalanine-d Equine Number of Reports Probable Possible 2 2 0 Presenting signs (probable and possible) Anorexia (1) Lethargy (1) Pyrexia (1) Shaking (1) Tachycardia (1) Pimobendan
Presenting signs (probable and possible) Vomiting (643) Lethargy (50) Anorexia (24) Diarrhoea (22) Depression (21) Lack of effect (17) Seizure (12) Pruritis (10) Ataxia (9) Malaise (9) Shaking (8) Nausea (7) Panting (7) Tremor (7) Erythema (6) Restless (6) Behavioural change (5) Somnolence (5) Hypersalivation (4) Hyperaesthesia (3) Rash (3) Urticaria (3) Disorientation (2) Frothing at the mouth (2) Periorbital swelling (2) Pyrexia (2) Agitation (1) Blood in faeces (1) Coughing (1) Distress (1) Hives (1) Hyperactivity (1) Hypersensitivity reaction (1) Irritation (skin) (1) Lesions (1) Prolapsed third eyelid (1) Pupillary light reflex (abnormal) (1) Red eyes (1) Regurgitation (1) Sedation (1) Stiffness (1) Tachycardia (1) Unknown (1) Vocalisation (1) Weakness (1) Welts (1) Ovine Number of Reports Probable Possible 48 6 42 Presenting signs (probable and possible) Lack of effect (47) Coat discoloration (1) Flystrike (1) Stabilised green-lipped mussel powder Canine Number of Reports Probable Possible 4 1 3 Presenting signs (probable and possible) Lethargy (2) Vomiting (2) Behavioural change (1) Diarrhoea (1)
Blisters (1) Burning sensation (1) Facial oedema (1) Numbness (1) Paraesthesia (1) Periorbital swelling (1) Pruritis (1) Pustules (1) Rash (1) Lignocaine as Lignocaine hydrochloride Human Number of Reports Probable Possible 1 1 0 Presenting signs (probable and possible) Respiratory problems (1) Lufenuron Human Number of Reports Probable Possible 1 0 1 Presenting signs (probable and possible) Urticaria (1) Milbemycin oxime Human Number of Reports Probable Possible 1 0 1 Presenting signs (probable and possible) Urticaria (1) Moxidectin Human Number of Reports Probable Possible 5 3 2