What is a serious reaction?
Serious reactions include those that are:
- fatal
- life-threatening
- disabling or incapacitating
- have resulted in or prolonged hospitalisation
- congenital abnormalities
- medically significant.
Examples of serious reactions
|
Blood |
Gastrointestinal |
Musculoskeletal |
|---|---|---|
|
Bone marrow dyscrasias |
Colitis |
Arthropathy |
|
Coagulopathies |
Haemorrhage |
Aseptic bone necrosis |
|
Haemolytic anaemias |
Hepatic cirrhosis |
Osteomalacia |
|
|
Hepatic dysfunction |
Pathological fracture |
|
Cardiovascular |
Hepatic fibrosis |
|
|
Arrhythmias |
Ileus |
Renal |
|
Cardiac arrest |
Pancreatitis |
Renal dysfunction |
|
Cardiac failure |
Perforation |
Urinary retention |
|
Cardiomyopathy |
Peritonitis (inc. fibrosing) |
|
|
Circulatory failure |
Pseudo-obstruction |
Reproduction |
|
Hypertension |
|
Spontaneous abortion |
|
Hypotension |
Immunological |
Antepartum haemorrhage |
|
Myocardial |
Anaphylaxis |
Congenital abnormalities |
|
Ischaemia/infarction |
Arteritis |
Eclampsia, pre-eclampsia |
|
Sudden death |
Drug fever |
Infertility |
|
|
Graft rejection |
Uterine haemorrhage, perforation |
|
Central nervous system |
Lupus syndrome |
|
|
Anorexia nervosa |
Polyarteritis nodosa |
Respiratory |
|
Catatonia |
Vasculitis |
Alveolitis (allergic, fibrosing) |
|
Cerebrovascular accident |
|
Bronchospasm (inc. exacerbation) |
|
Coma |
Malignancy |
Pneumonitis |
|
Confusional state |
Any |
Respiratory failure |
|
Dependence |
|
Thromboembolism |
|
Depression |
Metabolic |
|
|
Epilepsy (inc. exacerbations) |
Acidosis |
Skin |
|
Extrapyramidal reactions |
Adrenal dysfunction |
Angioedema |
|
Hallucinations |
Diabetes |
Bullous eruptions |
|
Hyperpyrexia |
Hypercalcaemia |
Epidermal necrolysis |
|
Intracranial pressure |
Hyperkalaemia |
Exfoliation (generalised) |
|
Myasthenia |
Hypokalaemia |
|
|
Neuroleptic malignant |
Hyponatraemia |
Special senses |
|
|
|
Cataract |
Why should I report serious reactions to established drugs, if the effects are well-known?
1. Established drugs and vaccines no longer require intensive monitoring as the safety of the product has been well established. However, previously unrecognised side effects, in particular rare or delayed effects, may still be identified when a medicine has been available for many years. For example, Reye's syndrome was associated with aspirin eight decades after it was first marketed. Therefore all established drugs and vaccines are continually monitored under the Yellow Card Scheme.
2. In addition to identification of previously unrecognised side effects, we also need to investigate well-known side effects in detail. This will allow us to give advice on:
- risk factors for patients such as age or concurrent disease
- how medicines can be used more safely.
3. If sufficient information about recognised reactions is gathered, we may be able to compare medicines in the same therapeutic class to investigate their relative safety. For instance, data from the Yellow Card Scheme has contributed to the evidence that among non-steroidal anti-inflammatory drugs, ibuprofen is associated with the lowest risk of gastrointestinal reactions.
What are severe reactions and should they be reported?
A severe reaction might not be life-threatening or disabling but can seriously affect an individual patient. For example, headaches are not normally considered serious in nature, but may be very severe. A severe or exaggerated adverse drug reaction (ADR) should be reported.
