Paracetamol Adverse events from historical clinical trial data are both infrequent and from small patient exposure. Accordingly, events reported from extensive post-marketing experience at therapeutic/labelled dose and considered attributable are tabulated below by system class.
The frequency of these adverse events is not known (cannot be estimated from available data). Body System Undesirable Effects Blood and lymphatic system disorders Thrombocytopenia Agranulocytosis These are not necessarily causally related to paracetamol Immune system disorders Anaphylaxis Cutaneous hypersensitivity reactions including, among others, Toxic Epidermal Necrolysis Stevens-Johnson syndrome, angiodema and skin rashes.
4). Pyroglutamic acidosis may occur as a consequence of low glutathione levels in these patients. **There have been cases of bronchospasm with paracetamol, but these are more likely in asthmatics sensitive to aspirin or other NSAIDs.
Phenylephrine 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 Effects Psychiatric disorders Nervousness, irritability, restlessness and excitability Nervous system disorders Headache, dizziness, insomnia Cardiac disorders Increased blood pressure Gastrointestinal disorders Nausea, vomiting, diarrhoea Caffeine Body System Undesirable Effects Central nervous system Nervousness Dizziness When the recommended paracetamol-caffeine-codeine dosing regimen is combined with dietary caffeine intake, the resulting higher dose of caffeine may increase the potential for caffeine-related adverse effects such as insomnia, restlessness, anxiety, irritability, headaches, gastrointestinal disturbances and palpitations.
Adverse reactions identified during post-marketing use are listed below. The frequency of these reactions is unknown but likely to be rare. System Organ Class Adverse Reaction Immune system disorders Hypersensitivity, allergic dermatitis, urticaria Eye disorders Acute angle glaucoma (most likely to occur in those with closed angle glaucoma), Mydriasis Cardiac disorders Tachycardia, palpitations Skin and subcutaneous disorders Hypersensitivity reactions including cross- sensitivity with other sympathomimetics may occur Renal and urinary disorders Urinary retention, dysuria.
This is most likely to occur in those with ladder outlet obstruction, such as prostatic hypertrophy. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
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