ting experience at therapeutic/labelled dose and considered attributable are tabulated below by MedDRA System Organ Class. Due to limited clinical trial data, the frequency of these adverse events is not known (cannot be estimated from available data), but post-marketing experience indicates that adverse reactions to paracetamol are rare and serious reactions are very rare.
Body System
Undesirable effect
Blood and lymphatic system disorders
Thrombocytopenia
Agranulocytosis
These are not necessarily causally related to paracetamol
Immune system disorders
Anaphylaxis
Cutaneous hypersensitivity reactions including skin rashes, angiodema and Stevens Johnson syndrome, toxic epidermal necrolysis
Respiratory, thoracic and mediastinal disorders
Bronchospasm*
Hepatobiliary disorders
Hepatic dysfunction
Gastrointestinal disorders
Acute pancreatitis
* There have been cases of bronchospasm with paracetamol, but these are more likely in asthmatics sensitive to aspirin or other NSAIDs.
The following adverse events have been observed in clinical trials with phenylephrine and may therefore represent the most commonly occurring adverse events.
Body System
Undesirable effect
Psychiatric disorders
Nervousness, irritability, restlessness, and excitability
Nervous system disorders
Headache, dizziness, insomnia
Cardiac disorders
Increased blood pressure
Gastrointestinal disorders
Nausea, Vomiting, diarrhoea
Adverse reactions identified during post-marketing use are listed below. The frequency of these reactions is unknown but likely to be rare.
Eye disorders
Mydriasis, acute angle closure glaucoma, most likely to occur in those with closed angle glaucoma
Cardiac disorders
Tachycardia, palpitations
Skin and subcutaneous disorders
Allergic reactions (e.g. rash, urticaria, allergic dermatitis).
Hypersensitivity reactions including cross-sensitivity with other sympathomimetics may occur.
Renal and urinary disorders
Dysuria, urinary retention. This is most likely to occur in those with bladder outlet obstruction, such as prostatic hypertrophy.
Guaifenesin
The frequency of these events is unknown but considered likely to be rare.
Body system
Undesirable effect
Immune system disorders
Allergic reactions, angioedema, anaphylactic reactions
Respiratory, thoracic and mediastinal disorders
Dyspnoea*
Gastrointestinal disorders
Nausea, vomiting, abdominal discomfort,
Skin and subcutaneous disorders
Rash, urticaria
4.9 Overdose
Paracetamol
Liver damage is possible in adults who have taken 10g or more of paracetamol. Ingestion of 5g or more of paracetamol may lead to liver damage if the patient has risk factors (see below).
Risk factors:
If the patient
a, Is on long term treatment with carbamazepine, phenobarbitone, phenytoin, primidone, rifampicin, St John's Wort or other drugs that induce liver enzymes.
Or
b, Regularly consum
