Serious reactions include those that are:-
- Fatal
- Life threatening
- Disabling
- Incapacitating
- Result in or prolong hospitalisation
- Medically significant
Blood
Bone marrow dyscrasias
Coagulopathies
Haemolytic anaemias
Cardiovascular
Arrhythmias
Cardiac arrest
Cardiac failure
Cardiomyopathy
Circulatory failure
Hypertension
Hypotension
Myocardial
Ischaemia/infarction
Sudden death
Central nervous system
Anorexia nervosa
Catatonia
Cerebrovascular accident
Coma
Confusional state
Dependence
Depression
Epilepsy (inc. exacerbations)
Extrapyramidal reactions
Hallucinations
Hyperpyrexia
Intracranial pressure
Myasthenia
Neuroleptic malignant
Neuropathy
Psychosis
Withdrawal syndrome
Gastrointestinal
Colitis
Haemorrhage
Hepatic cirrhosis
Hepatic dysfunction
Hepatic fibrosis
Ileus
Pancreatitis
Perforation
Peritonitis (inc. fibrosing)
Pseudo-obstruction
Immunological
Anaphylaxis
Arteritis
Drug fever
Graft rejection
Lupus syndrome
Polyarteritis nodosa
Vasculitis
Malignancy
Any
Metabolic
Acidosis
Adrenal dysfunction
Diabetes
Hypercalcaemia
Hyperkalaemia
Hypokalaemia
Hyponatraemia
Pituitary dysfunction
Porphyria
Thyroid dysfunction
Musculoskeletal
Arthropathy
Aseptic bone necrosis
Osteomalacia
Pathological fracture
Respiratory
Alveolitis (allergic, fibrosing)
Bronchospasm
(inc. exacerbation)
Pneumonitis
Respiratory failure
Thromboembolism
Skin
Angioedema
Bullous eruptions
Epidermal necrolysis
Exfoliation (generalised)
Special senses
Cataract
Corneal opacification
Glaucoma
Hearing loss
Vestibular dysfunction
Visual loss
