Differences between serious and severe reactions

This section provides information about reporting suspected adverse drug reactions for healthcare professionals. Information for patients is available in the 'Patient reporting of suspected adverse drug reactions' section (please see 'Related information on the right of this page').

What is a serious reaction?
Serious reactions include those that are:

  • fatal;
  • life-threatening;
  • disabling or incapacitating;
  • result in or prolong hospitalisation;
  • congenital abnormalities; or
  • 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


What is a severe reaction?
A severe reaction might not be life-threatening or disabling but in the individual patient it is extreme. An example would be a headache, which would not normally be considered serious but may be very severe.

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 in detail well known side effects. This may allow us to give advice on:

  • risk factors for patients such as age or concurrent disease; or
  • 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.


Page last modified: 20 September 2006